[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Rules and Regulations]
[Pages 53568-54229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24067]



[[Page 53567]]

Vol. 82

Thursday,

No. 220

November 16, 2017

Part II

Book 2 of 3 Books

Pages 53567-54230





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Part 414



 Medicare Program; CY 2018 Updates to the Quality Payment Program; and 
Quality Payment Program: Extreme and Uncontrollable Circumstance Policy 
for the Transition Year; Rule

  Federal Register / Vol. 82 , No. 220 / Thursday, November 16, 2017 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 414

[CMS-5522-FC and IFC]
RIN 0938-AT13


Medicare Program; CY 2018 Updates to the Quality Payment Program; 
and Quality Payment Program: Extreme and Uncontrollable Circumstance 
Policy for the Transition Year

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

ACTION: Final rule with comment period and interim final rule with 
comment period.

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SUMMARY: The Medicare Access and CHIP Reauthorization Act of 2015 
(MACRA) established the Quality Payment Program for eligible 
clinicians. Under the Quality Payment Program, eligible clinicians can 
participate via one of two tracks: Advanced Alternative Payment Models 
(APMs); or the Merit-based Incentive Payment System (MIPS). We began 
implementing the Quality Payment Program through rulemaking for 
calendar year (CY) 2017. This final rule with comment period provides 
updates for the second and future years of the Quality Payment Program.
    In addition, we also are issuing an interim final rule with comment 
period (IFC) that addresses extreme and uncontrollable circumstances 
MIPS eligible clinicians may face as a result of widespread 
catastrophic events affecting a region or locale in CY 2017, such as 
Hurricanes Irma, Harvey and Maria.

DATES: 
    Effective date: These provisions of this final rule with comment 
period and interim final rule with comment period are effective on 
January 1, 2018.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on January 1, 2018.

ADDRESSES: In commenting, please refer to file code CMS-5522-FC when 
commenting on issues in the final rule with comment period, and CMS-
5522-IFC when commenting on issues in the interim final rule with 
comment period. 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-5522-FC or CMS-5522-IFC (as 
appropriate), P.O. Box 8016, Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-5522-FC or CMS-
5522-IFC (as appropriate), 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.
    Benjamin Chin, (410) 786-0679, for inquiries related to APMs.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary and Background
    A. Overview
    B. Quality Payment Program Strategic Objectives
    C. One Quality Payment Program
    D. Summary of the Major Provisions
    1. Quality Payment Program Year 2
    2. Small Practices
    3. Summary of Major Provisions for Advanced Alternative Payment 
Models (Advanced APMs)
    4. Summary of Major Provisions for the Merit-Based Incentive 
Payment System (MIPS)
    E. Payment Adjustments
    F. Benefits and Costs of the Final Rule With Comment Period
    G. Automatic Extreme and Uncontrollable Circumstance Policy 
Interim Final Rule With Comment Period
    H. Stakeholder Input
II. Summary of the Provisions of the Proposed Regulations, and 
Analysis of and Responses to Public Comments
    A. Introduction
    B. Definitions
    C. MIPS Program Details
    1. MIPS Eligible Clinicians
    2. Exclusions
    3. Group Reporting
    4. Virtual Groups
    5. MIPS Performance Period
    6. MIPS Category Measures and Activities
    7. MIPS Final Score Methodology
    8. MIPS Payment Adjustments
    9. Review and Correction of MIPS Final Score
    10. Third Party Data Submission
    11. Public Reporting on Physician Compare
    D. Overview of the APM Incentive
    1. Overview
    2. Terms and Definitions
    3. Regulation Text Changes
    4. Advanced APMs
    5. Qualifying APM Participant (QP) and Partial QP Determinations
    6. All-Payer Combination Option
    7. Physician-Focused Payment Models (PFPMs)
III. Quality Payment Program: Extreme and Uncontrollable 
Circumstances Policy for the Transition Year Interim Final Rule With 
Comment Period
    A. Background
    B. Changes to the Extreme and Uncontrollable Circumstances 
Policies for the MIPS Transition Year
    C. Changes to the Final Score and Policies for Redistributing 
the Performance Category Weights for the Transition Year
    D. Changes to the APM Scoring Standard for MIPS Eligible 
Clinicians in MIPS APMs for the Transition Year
    E. Waiver of Proposed Rulemaking for Provisions Related to 
Extreme and Uncontrollable Circumstances
IV. Collection of Information Requirements
    A. Wage Estimates
    B. Framework for Understanding the Burden of MIPS Data 
Submission

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    C. ICR Regarding Burden for Virtual Group Election (Sec.  
414.1315)
    D. ICR Regarding Burden for Election of Facility-Based 
Measurement (Sec.  414.1380(e))
    E. ICRs Regarding Burden for Third-Party Reporting (Sec.  
414.1400)
    F. ICRs Regarding the Quality Performance Category (Sec. Sec.  
414.1330 and 414.1335)
    G. ICRs Regarding Burden Estimate for Advancing Care Information 
Data (Sec.  414.1375)
    H. ICR Regarding Burden for Improvement Activities Submission 
(Sec.  414.1355)
    I. ICR Regarding Burden for Nomination of Improvement Activities 
(Sec.  414.1360)
    J. ICRs Regarding Burden for Cost (Sec.  414.1350)
    K. ICR Regarding Partial QP Elections (Sec.  414.1430)
    L. ICRs Regarding Other Payer Advanced APM Determinations: 
Payer-Initiated Process (Sec.  414.1440) and Medicaid Specific 
Eligible Clinician Initiated Process (Sec.  414.1445)
    M. ICRs Regarding Burden for Voluntary Participants To Elect Opt 
Out of Performance Data Display on Physician Compare (Sec.  
414.1395)
    N. Summary of Annual Burden Estimates
    O. Submission of PRA-Related Comments
    P. Collection of Information Requirements for the Interim Final 
Rule With Comment Period: Medicare Program; Quality Payment Program: 
Extreme and Uncontrollable Circumstances Policy for the Transition 
Year
V. Response to Comments
VI. Regulatory Impact Analysis
    A. Statement of Need
    B. Overall Impact
    C. Changes in Medicare Payments
    D. Impact on Beneficiaries
    E. Regulatory Review Costs
    F. Accounting Statement
    G. Regulatory Impact Statement for Interim Final Rule With 
Comment Period: Medicare Program; Quality Payment Program: Extreme 
and Uncontrollable Circumstance Policy for the Transition Year

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
API Application Programming Interface
APM Alternative Payment Model
APRN Advanced Practice Registered Nurse
ASC Ambulatory Surgical Center
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 Core Based Statistical Area
CEHRT Certified EHR Technology
CFR Code of Federal Regulations
CHIP Children's Health Insurance Program
CJR Comprehensive Care for Joint Replacement
COI Collection of Information
CPR Customary, Prevailing, and Reasonable
CPS Composite Performance Score
CPT Current Procedural Terminology
CQM Clinical Quality Measure
CY Calendar Year
eCQM Electronic Clinical 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
HCC Hierarchical Condition Category
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
PHI Protected Health Information
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 Resource Use 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
VBP Value-Based Purchasing
VM Value-Based Payment Modifier
VPS Volume Performance Standard

I. Executive Summary and Background

A. Overview

    This final rule with comment period makes payment and policy 
changes to the Quality Payment Program. 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 (SGR) formula, to 
reauthorize the Children's Health Insurance Program (CHIP), and to 
strengthen Medicare access by improving physician and other clinician 
payments and making other improvements. The MACRA advances a forward-
looking, coordinated framework for clinicians to successfully take part 
in the 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).
    Our goal is to support patients and clinicians in making their own 
decisions about health care using data driven insights, increasingly 
aligned and meaningful quality measures, and innovative technology. To 
implement this vision, the Quality Payment Program emphasizes high-
value care and patient outcomes while minimizing burden on eligible 
clinicians. The Quality Payment Program is also designed to be 
flexible, transparent, and structured to improve over time with input 
from clinicians, patients, and other stakeholders.
    In today's health care system, we often pay doctors and other 
clinicians based on the number of services they perform rather than 
patient health outcomes. The good work that clinicians do is not 
limited to conducting tests or writing prescriptions, but also taking 
the time to have a conversation with a patient about test results, 
being available to a patient through telehealth or expanded hours, 
coordinating medicine and treatments to avoid confusion or errors, and 
developing care plans.
    The Quality Payment Program takes a comprehensive approach to 
payment by basing consideration of quality on a set of evidenced-based 
measures that were primarily developed by clinicians, thus encouraging 
improvement in clinical practice and supporting by advances in 
technology that allow for the easy exchange of information. The Quality 
Payment Program also offers special incentives for those participating 
in certain innovative models of care that

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provide an alternative to fee-for-service payment.
    We have sought and will continue to seek feedback from the health 
care community through various public avenues such as rulemaking, 
listening sessions and stakeholder engagement. We understand that 
technology, infrastructure, physician support systems, and clinical 
practices will change over the next few years and are committed to 
refine our policies for the Quality Payment Program with those factors 
in mind.
    We are aware of the diversity among clinician practices in their 
experience with quality-based payments and expect the Quality Payment 
Program to evolve over multiple years. The groundwork has been laid for 
expansion toward an innovative, patient-centered, health system that is 
both outcome focused and resource effective. A system that leverages 
health information technology to support clinicians and patients and 
builds collaboration across care settings. The Quality Payment Program: 
(1) Supports care improvement by focusing on better outcomes for 
patients, and preserving the independent clinical practice; (2) 
promotes the adoption of APMs that align incentives for high-quality, 
low-cost care across healthcare stakeholders; and (3) advances existing 
delivery system reform efforts, including ensuring a smooth transition 
to a healthcare system that promotes high-value, efficient care through 
unification of CMS legacy programs.
    In the 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 with comment 
period (81 FR 77008, November 4, 2016), referred to as the ``CY 2017 
Quality Payment Program final rule,'' we established incentives for 
participation in Advanced APMs, supporting the goals of transitioning 
from fee-for-service (FFS) payments to payments for quality and value. 
The CY 2017 Quality Payment Program final rule included definitions and 
processes to determine Qualifying APM Participants (QPs) in Advanced 
APMs. The CY 2017 Quality Payment Program final rule also established 
the criteria for use by the Physician-Focused Payment Model Technical 
Advisory Committee (PTAC) in making comments and recommendations to the 
Secretary on proposals for physician-focused payment models (PFPMs).
    The CY 2017 Quality Payment Program final rule also established 
policies to implement MIPS, which consolidated certain aspects of 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 made CY 2017 the 
transition year for clinicians under the Quality Payment Program. As 
prescribed by MACRA, MIPS focuses on the following: (1) Quality--
including a set of evidence-based, specialty-specific standards; (2) 
cost; (3) practice-based improvement activities; and (4) use of 
certified electronic health record (EHR) technology (CEHRT) to support 
interoperability and advanced quality objectives in a single, cohesive 
program that avoids redundancies.
    This CY 2018 final rule with comment period continues to build and 
improve upon our transition year policies, as well as, address elements 
of MACRA that were not included in the first year of the program, 
including virtual groups, beginning with the CY 2019 performance period 
facility-based measurement, and improvement scoring. This final rule 
with comment period implements policies for ``Quality Payment Program 
Year 2,'' some of which will continue into subsequent years of the 
Quality Payment Program.
    We have also included an interim final rule with comment period to 
establish an automatic extreme and uncontrollable circumstance policy 
for the 2017 MIPS performance period that recognizes recent hurricanes 
(Harvey, Irma, and Maria) and other natural disasters can effectively 
impede a MIPS eligible clinician's ability to participate in MIPS.

B. Quality Payment Program Strategic Objectives

    After extensive outreach with clinicians, patients and other 
stakeholders, we created 7 strategic objectives to drive continued 
progress and improvement. These objectives help guide our final 
policies and future rulemaking in order to design, implement, and 
advance a Quality Payment Program that aims to improve health outcomes, 
promote efficiency, 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 on program performance to 
provide accurate, timely, and actionable feedback to clinicians and 
other stakeholders; (6) to deliver IT systems capabilities that meet 
the needs of users for data submission, reporting, and improvement and 
are seamless, efficient and valuable on the front and back-end; and (7) 
to ensure operation excellence in program implementation and ongoing 
development; and to design the program in a manner that allows smaller 
independent and rural practices to be successful. More information on 
these objectives and the Quality Payment Program can be found at 
qpp.cms.gov.
    Stakeholder feedback is the hallmark of the Quality Payment 
Program. We solicited and reviewed nearly 1,300 comments and had over 
100,000 physicians and other stakeholders attend our outreach sessions 
to help inform our policies for Quality Payment Program Year 2. We have 
set ambitious yet achievable goals for those clinicians interested in 
APMs, as they are a vital part of bending the Medicare cost curve by 
encouraging the delivery of high-quality, low-cost care. To allow this 
program to work 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 APMs if that is the best choice for their practice. 
Finally, we understand that we must achieve excellence in program 
management, focusing on customer needs while also promoting problem-
solving, teamwork, and leadership to provide continuous improvements in 
the Quality Payment Program.

C. 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 goal 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-value care to their patients in a streamlined and 
cost-effective manner. Within MIPS, the second pathway of the Quality 
Payment Program, we believe that integration into typical clinical

[[Page 53571]]

workflows can best be accomplished by making connections across the 
four statutory pillars of the MIPS incentive structure. Those four 
pillars are: (1) Quality; (2) clinical practice improvement activities 
(referred to as ``improvement activities''); (3) meaningful use of 
CEHRT (referred to as ``advancing care information''); and (4) resource 
use (referred to as ``cost'').
    Although there are two separate pathways within the Quality Payment 
Program, Advanced APMs and MIPS both contribute toward the goal of 
seamless integration of the Quality Payment Program into clinical 
practice workflows. Advanced APMs promote this seamless integration by 
way of payment methodology and design that incentivize care 
coordination. The MIPS builds the capacity of eligible clinicians 
across the four pillars of MIPS to prepare them for participation in 
APMs in later years of the Quality Payment Program. Indeed, the bedrock 
of the Quality Payment Program is high-value, patient-centered care, 
informed by useful feedback, in a continuous cycle of improvement. The 
principal way that MIPS measures quality of care is through a set of 
clinical quality measures (CQMs) from which MIPS eligible clinicians 
can select. The CQMs are evidence-based, and the vast majority are 
created or supported by clinicians. Over time, the portfolio of quality 
measures will grow and develop, driving towards outcomes that are of 
the greatest importance to patients and clinicians and away from 
process, or ``check the box'' type measures.
    Through MIPS, we have the opportunity to measure clinical and 
patient outcomes, not only through evidence-based quality measures, but 
also by accounting for activities that clinicians and patients 
themselves identify: Namely, practice-driven quality improvement. MIPS 
also requires us to assess whether CEHRT is used in a meaningful way 
and based on significant feedback, this area was simplified to support 
the exchange of patient information, engagement of patients in their 
own care through technology, and the way technology specifically 
supports the quality goals selected by the practice. And lastly, MIPS 
requires us to measure the cost of services provided through the cost 
performance category, which will contribute to a MIPS eligible 
clinician's final score beginning in the second year of the MIPS.
    We realize the Quality Payment Program is a big change. In this 
final rule with comment period, we continue the slow ramp-up of the 
Quality Payment Program by establishing special policies for MIPS Year 
2 aimed at encouraging successful participation in the program while 
reducing burden, reducing the number of clinicians required to 
participate, and preparing clinicians for the CY 2019 performance 
period (CY 2021 payment year). 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.

D. Summary of the Major Provisions

1. Quality Payment Program Year 2
    We believe the second year of the Quality Payment Program should 
build upon the foundation that has been established which provides a 
trajectory for clinicians to value-based care. A second year to ramp-up 
the program will continue to help build upon the iterative learning and 
development of year 1 in preparation for a robust program in year 3.
2. Small Practices
    The support of small, independent practices remains an important 
thematic objective for the implementation of the Quality Payment 
Program and is expected to be carried throughout future rulemaking. 
Many small practices did not have to participate in MIPS during the 
transition year due to the low-volume threshold, which was set for the 
CY 2017 performance period at less than or equal to $30,000 in Medicare 
Part B allowed charges or less than or equal to 100 Medicare Part B 
patients. We have heard feedback that many small practices still face 
challenges in their ability to participate in the program. We are 
implementing additional flexibilities for Year 2 including: 
Implementing the virtual groups provisions; increasing the low-volume 
threshold to less than or equal to $90,000 in Medicare Part B allowed 
charges or less than or equal to 200 Medicare Part B patients; adding a 
significant hardship exception from the advancing care information 
performance category for MIPS eligible clinicians in small practices; 
providing 3 points even if small practices submit quality measures 
below data completeness standards; and providing bonus points that are 
added to the final scores of MIPS eligible clinicians who are in small 
practices. We believe that these additional flexibilities and reduction 
in barriers will further enhance the ability of small practices to 
participate successfully in the Quality Payment Program.
    In keeping with the objectives to provide education about the 
Quality Payment Program and maximize participation, and as mandated by 
the statute, during a period of 5 years, $100 million in funding was 
provided for technical assistance to be available to provide guidance 
and assistance to MIPS eligible clinicians in small practices through 
contracts with regional health collaboratives, and others. Guidance and 
assistance on the MIPS performance categories or the transition to APM 
participation will be available to MIPS eligible clinicians in 
practices of 15 or fewer clinicians with priority given to practices 
located in rural areas or medically underserved areas (MUAs), and 
practices with low MIPS final scores. More information on the technical 
assistance support available to small practices can be found at https://qpp.cms.gov/docs/QPP_Support_for_Small_Practices.pdf.
    We have also performed an updated regulatory impact analysis, 
accounting for flexibilities, many of which are continuing into the 
Quality Payment Program Year 2, that have been created to ease the 
burden for small and solo practices.
3. Summary of Major Provisions for Advanced Alternative Payment Models 
(Advanced APMs)
a. Overview
    APMs represent an important step forward in our efforts to move our 
healthcare system from volume-based to value-based care. Our existing 
APM policies provide opportunities that support state flexibility, 
local leadership, regulatory relief, and innovative approaches to 
improve quality, accessibility, and affordability.
    APMs that meet the criteria to be Advanced APMs provide the pathway 
through which eligible clinicians, many of whom who would otherwise 
fall under the MIPS, can become Qualifying APM Participants (QPs), 
thereby earning incentives for their Advanced APM participation. In the 
CY 2017 Quality Payment Program final rule, we estimated that 70,000 to 
120,000 eligible clinicians would be QPs for payment year 2019 based on 
Advanced APM participation in performance year 2017 (81 FR 77516). With 
new Advanced APMs expected to be available for participation in 2018, 
including the Medicare ACO Track 1 Plus (1+) Model, and the addition of 
new participants for some current Advanced APMs, such as the Next 
Generation ACO Model and Comprehensive Primary Care Plus (CPC+) Model, 
we anticipate higher numbers of QPs in subsequent years of the program. 
We currently estimate that approximately 185,000 to 250,000

[[Page 53572]]

eligible clinicians may become QPs for payment year 2020 based on 
Advanced APM participation in performance year 2018.
b. Advanced APMs
    In the CY 2017 Quality Payment Program final rule, to be considered 
an Advanced APM, we finalized that 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 (81 FR 77408).
    We are maintaining the generally applicable revenue-based nominal 
amount standard at 8 percent for QP Performance Periods 2019 and 2020. 
We are exempting participants in Round 1 of the CPC+ Model as of 
January 1, 2017 from the 50 eligible clinician limit as proposed. We 
are also finalizing a more gradual ramp-up in percentages of revenue 
for the Medical Home Model nominal amount standard over the next 
several years.
c. Qualifying APM Participant (QP) and Partial QP Determinations
    QPs are eligible clinicians in an Advanced APM who have met a 
threshold percentage of their patients or payments through an Advanced 
APM or, beginning in performance year 2019, attain QP status through 
the All-Payer Combination Option. Eligible clinicians who are QPs for a 
year are excluded from the MIPS reporting requirements and payment 
adjustment for the year, and receive a 5 percent APM Incentive Payment 
for the year in years from 2019 through 2024. The statute sets 
thresholds for the level of participation in Advanced APMs required for 
an eligible clinician to become a QP for a year.
    We are finalizing that for Advanced APMs that start or end during 
the QP Performance Period and operate continuously for a minimum of 60 
days during the QP Performance Period for the year, we are making QP 
determinations using payment or patient data only for the dates that 
APM Entities were able to participate in the Advanced APM per the terms 
of the Advanced APM, not for the full QP Performance Period.
    Eligible clinicians who participate in Advanced APMs but do not 
meet the QP or Partial QP thresholds are subject to MIPS reporting 
requirements and payment adjustments unless they are otherwise excluded 
from MIPS.
d. All-Payer Combination Option
    The All-Payer Combination Option, which uses a calculation based on 
an eligible clinician's participation in both Advanced APMs and Other 
Payer Advanced APMs to make QP determinations, is applicable beginning 
in performance year 2019. To become a QP through the All-Payer 
Combination Option, an eligible clinician must participate in an 
Advanced APM with CMS as well as an Other Payer Advanced APM. We 
determine whether other payer arrangements are Other Payer Advanced 
APMs based on information submitted to us by eligible clinicians, APM 
Entities, and in some cases by payers, including states and Medicare 
Advantage Organizations. In addition, the eligible clinician or the APM 
Entity must submit information to CMS so that we can determine whether 
the eligible clinician meets the requisite QP threshold of 
participation.
    To be an Other Payer Advanced APM, as set forth in section 
1833(z)(2)(B)(ii) and (C)(ii) of the Act and implemented in the CY 2017 
Quality Payment Program final rule, a payment arrangement with a payer 
(for example, payment arrangements authorized under Title XIX, Medicare 
Health Plan payment arrangements, and payment arrangements in CMS 
Multi-Payer Models) must meet all three of the following criteria: (1) 
CEHRT is used; (2) the payment arrangement must require the use of 
quality measures comparable to those in the quality performance 
category under MIPS; and (3) the payment arrangement must either 
require the APM Entities to 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.
    In this final rule with comment period, we are finalizing policies 
that provide more detail about how the All-Payer Combination Option 
will operate. We are finalizing that an other payer arrangement would 
meet the generally applicable revenue-based nominal amount standard we 
proposed if, under the terms of the other payer arrangement, the total 
amount that an APM Entity potentially owes the payer or foregoes is 
equal to at least: For the 2019 and 2020 QP Performance Periods, 8 
percent of the total combined revenues from the payer of providers and 
suppliers in participating APM Entities only for arrangements that are 
expressly defined in terms of revenue. We are also finalizing a more 
gradual ramp-up in percentages of revenue for the Medicaid Medical Home 
Model nominal amount standard over the next several years.
    We are finalizing the Payer Initiated and Eligible Clinician Other 
Payer Advanced APM determination processes to allow payers, APM 
Entities, or eligible clinicians to request that we determine whether 
other payer arrangements meet the Other Payer Advanced APM criteria. We 
have also finalized requirements pertaining to the submission of 
information.
    We are finalizing certain modifications to how we calculate 
Threshold Scores and make QP determinations under the All-Payer 
Combination Option. We are retaining the QP Performance Period for the 
All-Payer Combination Option from January 1 through August 31 of each 
year as finalized in the CY 2017 Quality Payment Program final rule.
e. Physician-Focused Payment Models (PFPMs)
    The PTAC is an 11-member federal advisory committee that is an 
important avenue for the creation of innovative payment models. The 
PTAC is charged with reviewing stakeholders' proposed PFPMs, and making 
comments and recommendations to the Secretary regarding whether they 
meet the PFPM criteria established by the Secretary through rulemaking 
in the CY 2017 Quality Payment Program final rule. The Secretary is 
required to review the comments and recommendations submitted by the 
PTAC and post a detailed response to these recommendations on the CMS 
Web site.
    We sought comments on broadening the definition of PFPM to include 
payment arrangements that involve Medicaid or the Children's Health 
Insurance Program (CHIP) as a payer even if Medicare is not included as 
a payer. We are maintaining the current definition of a PFPM to include 
only payment arrangements with Medicare as a payer. We believe this 
definition retains focus on APMs and Advanced APMs, which would be 
proposals that the Secretary has more direct authority to implement, 
while maintaining consistency for PTAC's review while they are still 
refining their processes. In addition, we sought comment on the 
Secretary's criteria and stakeholders' needs in developing PFPM 
proposals aimed at meeting the criteria.

[[Page 53573]]

4. Summary of Major Provisions for the Merit-Based Incentive Payment 
System (MIPS)
    For Quality Payment Program Year 2, which is the second year of the 
MIPS and includes the 2018 performance period and the 2020 MIPS payment 
year, as well as the following:
a. Quality
    We previously finalized that the quality performance category would 
comprise 60 percent of the final score for the transition year and 50 
percent of the final score for the 2020 MIPS payment year (81 FR 
77100). While we proposed to maintain a 60 percent weight for the 
quality performance category for the 2020 MIPS payment year, we are not 
finalizing this proposal and will be keeping our previously finalized 
policy to weight the quality performance category at 50 percent for the 
2020 MIPS payment year. We are also finalizing that for purposes of the 
2021 MIPS payment year, the performance period for the quality and cost 
performance categories is CY 2019 (January 1, 2019 through December 31, 
2019). We note that we had previously finalized that for the 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). We did not make proposals to modify this time frame 
in the CY 2018 Quality Payment Program proposed rule and are therefore 
unable to modify this performance period.
    Quality measures are selected annually through a call for quality 
measures under consideration, with a final list of quality measures 
being published in the Federal Register by November 1 of each year. We 
are finalizing for the CAHPS for MIPS survey for the Quality Payment 
Program Year 2 and future years that the survey administration period 
will, at a minimum, span over 8 weeks and, at a maximum, 17 weeks and 
will end no later than February 28th following the applicable 
performance period. In addition, we are finalizing for the Quality 
Payment Program Year 2 and future years to remove two Summary Survey 
Modules (SSMs), specifically, ``Helping You to Take Medication as 
Directed'' and ``Between Visit Communication'' from the CAHPS for MIPS 
survey.
    For the 2018 MIPS performance period, we previously finalized that 
the data completeness threshold would increase to 60 percent for data 
submitted on quality measures using QCDRs, qualified registries, via 
EHR, or Medicare Part B claims. While we proposed to maintain a 50 
percent data completeness threshold for the 2018 MIPS performance 
period, we are not finalizing this proposal and will be keeping our 
previously finalized data completeness threshold of 60 percent for data 
submitted on quality measures using QCDRs, qualified registries, EHR, 
or Medicare Part B claims for the 2018 MIPS performance period. We also 
proposed to have the data completeness threshold for the 2021 MIPS 
payment year (2019 performance period) to 60 percent for data submitted 
on quality measures using QCDRs, qualified registries, EHR, or Medicare 
Part B claims. We are also finalizing this proposal. We anticipate that 
as MIPS eligible clinicians gain experience with the MIPS we will 
propose to further increase these thresholds over time.
b. Improvement Activities
    Improvement activities are those that improve clinical practice or 
care delivery and that, when effectively executed, are likely to result 
in improved outcomes. We believe improvement activities support broad 
aims within healthcare delivery, including care coordination, 
beneficiary engagement, population management, and health equity. For 
the 2020 MIPS payment year, we previously finalized that the 
improvement activities performance category would comprise 15 percent 
of the final score (81 FR 77179). There are no changes in improvement 
activities scoring for Quality Payment Program Year 2 (2018 MIPS 
performance period) as discussed in section II.C.7.a.(5) of this final 
rule with comment period. However, in this final rule, we are 
finalizing our proposal to no longer require self-identifications for 
non-patient facing MIPS eligible clinicians, small practices, practices 
located in rural areas or geographic HPSAs, or any combination thereof, 
beginning with the 2018 MIPS performance period and for future years.
    We are finalizing that for Quality Payment Program Year 2 and 
future years (2018 MIPS performance period and future years), MIPS 
eligible clinicians or groups must submit data on improvement 
activities in one of the following manners: Via qualified registries, 
EHR submission mechanisms, QCDR, CMS Web Interface, or attestation; and 
that for activities that are performed for at least a continuous 90 
days during the performance period, MIPS eligible clinicians must 
submit a yes response for activities within the Improvement Activities 
Inventory.
    In this final rule with comment period, we are finalizing updates 
to the Improvement Activities Inventory. Specifically, as discussed in 
the appendices (Tables F and G) of this final rule with comment period, 
we are finalizing 21 new improvement activities (some with 
modification) and changes to 27 previously adopted improvement 
activities (some with modification and including 1 removal) for the 
Quality Payment Program Year 2 and future years (2018 MIPS performance 
period and future years) Improvement Activities Inventory. These 
activities were recommended by clinicians, patients and other 
stakeholders interested in advancing quality improvement and 
innovations in healthcare. We will continue to seek new improvement 
activities as the program evolves. Additionally, we are finalizing 
several policies related to submission of improvement activities. In 
particular, we are formalizing the annual call for activities process 
for Quality Payment Program Year 3 and future years. We are finalizing 
with modification, for the Quality Payment Program Year 3 and future 
years, that stakeholders should apply one or more of the criteria when 
submitting improvement activities in response to the Annual Call for 
Activities. In addition to the criteria listed in the proposed rule for 
nominating new improvement activities for the Annual Call for 
Activities policy, we are modifying and expanding the proposed criteria 
list to also include: (1) Improvement activities that focus on 
meaningful actions from the person and family's point of view, and (2) 
improvement activities that support the patient's family or personal 
caregiver. In addition, we are finalizing to: (1) Accept submissions 
for prospective improvement activities at any time during the 
performance period for the Annual Call for Activities and create an 
Improvement Activities Under Review (IAUR) list; (2) only consider 
prospective activities submitted by March 1 for inclusion in the 
Improvement Activities Inventory for the performance periods occurring 
in the following calendar year; and (3) add new improvement activities 
and subcategories through notice-and-comment rulemaking in future years 
of the Quality Payment Program.
    Additionally, we are finalizing that for purposes of the 2021 MIPS 
payment year, the performance period for the improvement activities 
performance category is a minimum of a continuous 90-day period within 
CY 2019, up to and including the full CY 2019 (January 1, 2019 through 
December 31, 2019).
    In this final rule with comment period, we are also expanding our

[[Page 53574]]

definition of how we will recognize an individual MIPS eligible 
clinician or group as being a certified patient-centered medical home 
or comparable specialty practice. We are finalizing our proposal, with 
clarification, that at least 50 percent of the practice sites within 
the TIN must be recognized as a patient-centered medical home or 
comparable specialty practice to receive full credit as a certified or 
recognized patient-centered medical home or comparable specialty 
practice for the 2020 MIPS payment year and future years. We are 
clarifying that a practice site as is the physical location where 
services are delivered. We proposed in section II.C.6.e.(3)(b) of the 
proposed rule (82 FR 30054) that eligible clinicians in practices that 
have been randomized to the control group in the CPC+ model would also 
receive full credit as a Medical Home Model. We are not finalizing this 
proposal, however, because CMMI has not randomized any practices into a 
control group in CPC+ Round 2.
    We are also finalizing changes to the study, including modifying 
the name to the ``CMS Study on Burdens Associated with Reporting 
Quality Measures,'' increasing the sample size for 2018, and updating 
requirements.
    Furthermore, in recognition of improvement activities as supporting 
the central mission of a unified Quality Payment Program, we are 
finalizing in section II.C.6.e.(3)(a) of this final rule with comment 
period to continue to designate activities in the Improvement 
Activities Inventory that will also qualify for the advancing care 
information bonus score. This is consistent with our desire to 
recognize that CEHRT is often deployed to improve care in ways that our 
programs should recognize.
c. Advancing Care Information
    For the Quality Payment Program Year 2, the advancing care 
information performance category is 25 percent of the final score. 
However, if a MIPS eligible clinician is participating in a MIPS APM 
the advancing care information performance category may be 30 percent 
or 75 percent of the final score depending on the availability of APM 
quality data for reporting. We are finalizing that for purposes of the 
2021 MIPS payment year, the performance period for advancing care 
information performance category is a minimum of a continuous 90-day 
period within CY 2019, up to and including the full CY 2019 (January 1, 
2019 through December 31, 2019).
    Objectives and measures in the advancing care information 
performance category focus on the secure exchange of health information 
and the use of CEHRT to support patient engagement and improved 
healthcare quality. While we continue to recommend that physicians and 
clinicians migrate to the implementation and use of EHR technology 
certified to the 2015 Edition so they may take advantage of improved 
functionalities, including care coordination and technical advancements 
such as application programming interfaces, or APIs, we recognize that 
some practices may have challenges in adopting new certified health IT. 
Therefore, we are finalizing that MIPS eligible clinicians may continue 
to use EHR technology certified to the 2014 Edition for the performance 
period in CY 2018. Clinicians may also choose to use the 2015 Edition 
CEHRT or a combination of the two. Clinicians will earn a bonus for 
using only 2015 CEHRT in 2018.
    For the 2018 performance period, MIPS eligible clinicians will have 
the option to report the Advancing Care Information Transition 
Objectives and Measures using 2014 Edition CEHRT, 2015 Edition CEHRT, 
or a combination of 2014 and 2015 Edition CEHRT, as long as the EHR 
technology they possess can support the objectives and measures to 
which they plan to attest. Similarly, MIPS eligible clinicians will 
have the option to attest to the Advancing Care Information Objectives 
and Measures using 2015 Edition CEHRT or a combination of 2014 and 2015 
Edition CEHRT, as long as their EHR technology can support the 
objectives and measures to which they plan to attest.
    We are finalizing exclusions for the e-Prescribing and Health 
Information Exchange Objectives beginning with the 2017 performance 
period. We are also finalizing that eligible clinicians can earn 10 
percentage points in their performance score for reporting to any 
single public health agency or clinical data registry to meet any of 
the measures associated with the Public Health and Clinical Data 
Registry Reporting objective (or any of the measures associated with 
the Public Health Reporting Objective of the 2018 Advancing Care 
Information Transition Objectives and Measures, for clinicians who 
choose to report on those measures) and, and will award an additional 5 
percentage point bonus for reporting to more than one. We are 
implementing several provisions of the 21st Century Cures Act (Pub. L. 
114-255, enacted on December 13, 2016) pertaining to hospital-based 
MIPS eligible clinicians, ambulatory surgical center-based MIPS 
eligible clinicians, MIPS eligible clinicians using decertified EHR 
technology, and significant hardship exceptions under the MIPS. We are 
also finalizing a significant hardship exception for MIPS eligible 
clinicians in small practices. For clinicians requesting a reweighting 
of the advancing care information performance category, we are changing 
the deadline for submission of this application to December 31 of the 
performance period. Lastly, we are finalizing additional improvement 
activities that are eligible for a 10 percent bonus under the advancing 
care information performance category if they are completed using 
CEHRT.
d. Cost
    We previously finalized that the cost performance category would 
comprise zero percent of the final score for the transition year and 10 
percent of the final score for the 2020 MIPS payment year (81 FR 
77165). For the 2020 MIPS payment year, we proposed to change the 
weight of the cost performance category from 10 percent to zero percent 
(82 FR 30047). For the 2020 MIPS payment year, we are finalizing a 10 
percent weight for the cost performance category in the final score in 
order to ease the transition to a 30 percent weight for the cost 
performance category in the 2021 MIPS payment year. For the 2018 MIPS 
performance period, we are adopting the total per capita costs for all 
attributed beneficiaries measure and the Medicare Spending per 
Beneficiary (MSPB) measure that were adopted for the 2017 MIPS 
performance period, and we will not use the 10 episode-based measures 
that were adopted for the 2017 MIPS performance period. Although data 
on the episode-based measures has been made available to clinicians in 
the past, we are in the process of developing new episode-based 
measures with significant clinician input and believe it would be more 
prudent to introduce these new measures over time. We will continue to 
offer performance feedback on episode-based measures prior to potential 
inclusion of these measures in MIPS to increase clinician familiarity 
with the concept as well as specific episode-based measures. 
Specifically, we are providing feedback on these new episode-based cost 
measures for informational purposes only. We intend to provide 
performance feedback on the MSPB and total per capita cost measures by 
July 1, 2018, consistent with section 1848(q)(12) of the Act. In 
addition, we intend to offer feedback on newly developed episode-based 
cost measures in 2018 as well.

[[Page 53575]]

e. Submission Mechanisms
    We are finalizing additional flexibility for submitting data 
through multiple submission mechanisms. Due to operational reasons and 
to allow additional time to communicate how this policy intersects with 
our measure applicability policies, this policy will not be implemented 
for the 2018 performance period but will be implemented instead for the 
2019 performance period of the Quality Payment Program. Individual MIPS 
eligible clinicians or groups will be able to submit measures and 
activities, as available and applicable, via as many mechanisms as 
necessary to meet the requirements of the quality, improvement 
activities, or advancing care information performance categories for 
the 2019 performance period. This option will provide clinicians the 
ability to select the measures most meaningful to them, regardless of 
the submission mechanism.
    Also, given stakeholder concerns regarding CMS' multiple 
submissions mechanism policy, we want to clarify that under the 
validation process for Year 3, MIPS eligible clinicians who submit via 
claims or registry submission only or a combination of claims and 
registry submissions would not be required to submit measures through 
other mechanisms to meet the quality performance category criteria; 
rather, it is an option available to MIPS eligible clinicians which may 
increase their quality performance category score. We expect that MIPS 
eligible clinicians would choose the submission mechanism that would 
give them 6 measures to report. Our intention is to offer multiple 
submission mechanisms to increase flexibility for MIPS individual 
clinicians and groups. We are not requiring that MIPS individual 
clinicians and groups submit via additional submission mechanisms; 
however, through this policy the option would be available for those 
that have applicable measures and/or activities available to them.
f. Virtual Groups
    Virtual groups are a new way to participate in MIPS starting with 
the 2018 MIPS performance period. For the 2018 performance period, 
clinicians can participate in MIPS as an individual, as a group, as an 
APM Entity in a MIPS APM, or as a virtual group.
    For the implementation of virtual groups as a participation option 
under MIPS, we are establishing the following policies. We are defining 
a virtual group as a combination of two or more TINs assigned to one or 
more solo practitioners or one or more groups consisting of 10 or fewer 
eligible clinicians that elect to form a virtual group for a 
performance period for a year. In order for solo practitioners or such 
groups to be eligible to join a virtual group, the solo practitioners 
and the groups would need to exceed the low-volume threshold. A solo 
practitioner or a group that does not exceed the low-volume threshold 
could not participate in a virtual group, and it is not permissible 
under the statute to apply the low-volume threshold at the virtual 
group level. Also, we are finalizing our virtual group policies to 
clearly delineate those group-related policies that apply to virtual 
groups versus policies that only apply to virtual groups.
    Virtual groups are required to make an election to participate in 
MIPS as a virtual group prior to the start of an applicable performance 
period. We are also finalizing a two-stage virtual group election 
process for the applicable 2018 and 2019 performance periods. The first 
stage is the optional eligibility stage, but for practices that do not 
choose to participate in stage 1 of the election process, we will make 
an eligibility determination during stage 2 of the election process. 
The second stage is the virtual group formation stage. We are also 
finalizing that virtual groups must have a formal written agreement 
among each party of a virtual group. The election deadline will be 
December 31.
    To provide support and reduce burden, we intend to make technical 
assistance (TA) available, to the extent feasible and appropriate, to 
support clinicians who choose to come together as a virtual group for 
the first 2 years of virtual group implementation applicable to the 
2018 and 2019 performance years. Clinicians already receiving technical 
assistance may continue to do so for virtual groups support; otherwise, 
the Quality Payment Service Center is available to assist and connect 
virtual groups with a technical assistance representative. For year 2, 
we believe that we have created an election process that is simple and 
straightforward. For Quality Payment Program Year 3, we intend to 
provide an electronic election process, if technically feasible.
    Virtual groups are required to meet the requirements for each 
performance category and responsible for aggregating data for their 
measures and activities across the virtual group, for example, across 
their TINs. In future years, we intend to examine how we define 
``group'' under MIPS with respect to flexibility in composition and 
reporting.
g. MIPS APMs
    MIPS eligible clinicians who participate in MIPS APMs are scored 
using the APM scoring standard instead of the generally applicable MIPS 
scoring standard. For the 2018 performance period, we are finalizing 
modifications to the quality performance category reporting 
requirements and scoring for MIPS eligible clinicians in MIPS APMs, and 
other modifications to the APM scoring standard. For purposes of the 
APM scoring standard, we are adding a fourth snapshot date that would 
be used only to identify eligible clinicians in APM Entity groups 
participating in those MIPS APMs that require full TIN participation. 
This snapshot date will not be used to make QP determinations. Along 
with the other APM Entity groups, these APM Entity groups would be used 
for the purposes of reporting and scoring under the APM scoring 
standard described in the CY 2017 Quality Payment Program final rule 
(81 FR 77246).
h. Facility-Based Measurement
    We solicited comments on implementing facility-based measurement 
for the 2018 MIPS performance period and future performance periods to 
add more flexibility for clinicians to be assessed in the context of 
the facilities at which they work. We described facility-based measures 
policies related to applicable measures, applicability to facility-
based measurement, group participation, and facility attribution. For 
clinicians whose primary professional responsibilities are in a 
healthcare facility we presented a method to assess performance in the 
quality and cost performance categories of MIPS based on the 
performance of that facility in another value-based purchasing program.
    After much consideration, we are finalizing our proposal to allow 
clinicians to use facility-based measurement in year 3 (2019) of the 
Quality Payment Program. We will use the 2018 year to ensure that 
clinicians better understand the opportunity and ensure operational 
readiness to offer facility-based measurement.
i. Scoring
    In the transition year of the Quality Payment Program, we finalized 
a unified scoring system to determine a final score across the 4 
performance categories (81 FR 77273 through 77276). For the 2018 MIPS 
performance period, we will build on the scoring methodology we 
finalized for the transition year, focusing on encouraging

[[Page 53576]]

MIPS eligible clinicians to meet data completeness requirements.
    For quality performance category scoring, we are finalizing to 
extend some of the transition year policies to the 2018 MIPS 
performance period and also finalizing several modifications to 
existing policy. Quality measures that can be scored against a 
benchmark that meet data completeness standards, and meet the minimum 
case size requirements will continue to receive between 3 and 10 points 
as measure achievement points. Measures that do not have a benchmark or 
meet the case minimum requirement will continue to receive 3 points.
    For quality data submitted via EHR, QCDR, or qualified registry, we 
are lowering the number of points available for measures that do not 
meet the data completeness criteria to 1 point, except for a measure 
submitted by a small practice, which we will continue to assign 3 
points.
    We are finalizing a timeline to identify and propose to remove 
topped out quality measures through future rulemaking. We are 
evaluating additional considerations needed to maintain measures for 
important aspects of care, such as patient safety and high reliability, 
and will address this in future rulemaking. We are finalizing a policy 
of applying a scoring cap to identified topped out measures with 
measure benchmarks that have been topped out for at least 2 consecutive 
years; however, based on feedback, we will award up to 7 points for 
topped out measures rather than the 6 points originally proposed. We 
are finalizing the special scoring policy for the 6 measures identified 
for the 2018 performance period with a 7-point scoring cap.
    We are also excluding CMS Web Interface measures from topped out 
scoring, but we will continue to monitor differences between CMS Web 
Interface and other submission options. We intend to address CAHPS 
through future rulemaking.
    Beginning with the 2018 MIPS performance period, we are finalizing 
measuring improvement scoring at the performance category level for the 
quality performance category, but we will monitor this approach and 
revisit as needed through future rule making. We are finalizing 
measuring improvement scoring at the measure level for the cost 
performance category.
    For the 2018 MIPS performance period, the quality, improvement 
activities, cost and advancing care information performance category 
scores will be given weight in the final score, or be reweighted if a 
performance category score is not available.
    We are also finalizing small practice and complex patient bonuses 
only for the 2020 MIPS payment year. The small practice bonus of 5 
points will be applied to the final score for MIPS eligible clinicians 
in groups, virtual groups, or APM Entities that have 15 or fewer 
clinicians and that submit data on at least one performance category in 
the 2018 performance period. We will also apply a complex patient bonus 
capped at 5 points using the dual eligibility ratio and average HCC 
risk score. We increased the complex patients bonus from 3 points as 
proposed in part to align with the small practice bonus. The final 
score will be compared against the MIPS performance threshold of 15 
points for the 2020 MIPS payment year, a modest increase from 3 points 
in the transition year. A 15-point final score equal to the performance 
threshold can be achieved via multiple pathways and continues the 
gradual transition into MIPS. The additional performance threshold for 
exceptional performance will remain at 70 points, the same as for the 
transition year.
    We are finalizing a policy of applying the MIPS payment adjustment 
to the Medicare paid amount.
j. Performance Feedback
    We proposed and are finalizing the policy to provide Quality 
Payment Program performance feedback to eligible clinicians and groups. 
Initially, we will provide performance feedback on an annual basis. In 
future years, we aim to provide performance feedback on a more frequent 
basis, which is in line with clinician requests for timely, actionable 
feedback that they can use to improve care.
k. Third Party Intermediaries
    In the CY 2017 Quality Payment Program final rule (81 FR 77362), we 
finalized that qualified registries, QCDRs, health IT vendors, and CMS-
approved survey vendors will have the ability to act as intermediaries 
on behalf of individual MIPS eligible clinicians and groups for 
submission of data to CMS across the quality, improvement activities, 
and advancing care information performance categories.
    Regarding QCDRs and qualified registries, we are finalizing our 
proposal to eliminate the self-nomination submission method of email 
and require that QCDRs and qualified registries submit their self-
nomination applications via a web-based tool for future program years 
beginning with the 2018 performance period. Beginning with the 2019 
performance period, we are finalizing the use of a simplified self-
nomination process for previously approved QCDRs and qualified 
registries in good standing.
    In addition, regarding information a QCDR specifically must provide 
to us at the time of self-nomination, we are making a number of 
clarifications, finalized that the term ``QCDR measures'' will replace 
the existing term of ``non-MIPS measures'', and sought public input on 
requiring full development and testing of QCDR measures by submission. 
We have also made a few clarifications to existing criteria as they 
pertain to qualified registries.
    We are not making any changes to the health IT vendors that obtain 
data from CEHRT requirements. Regarding CMS-approved survey vendors, we 
are finalizing that for the Quality Payment Program year 2 and for 
future years, that the vendor application deadline be January 31st of 
the applicable performance year or a later date specified by CMS. 
Lastly, based on comments we received on the 10-year record retention 
period and our interest in reducing financial and time burdens under 
this program and having consistent policies across this program, we are 
aligning our record retention period across the program by modifying 
our proposal for third parties from 10 years to finalize a 6-year 
retention period. Therefore, we are finalizing that entities must 
retain all data submitted to us for purposes of MIPS for a 6 years from 
the end of the MIPS performance period.
l. Public Reporting
    As discussed in section II.C.11. of this final rule with comment 
period, we proposed and are finalizing public reporting of certain 
eligible clinician and group Quality Payment Program information, 
including MIPS and APM data in an easily understandable format as 
required under the MACRA.
m. Eligibility and Exclusion Provisions of the MIPS Program
    We are modifying the definition of a non-patient facing MIPS 
eligible clinician to apply to virtual groups. In addition, we are 
finalizing our proposal to specify that groups considered to be non-
patient facing (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 
would automatically have their advancing care information performance 
category reweighted to zero.

[[Page 53577]]

    Additionally, we are finalizing our proposal to increase the low-
volume threshold to less than or equal to $90,000 in Medicare Part B 
allowed charges or 200 or fewer Part-B enrolled Medicare beneficiaries 
to further decrease burden on MIPS eligible clinicians that practice in 
rural areas or are part of a small practice or are solo practitioners. 
We are not finalizing our proposal to provide clinicians the ability to 
opt-in to MIPS if they meet or exceed one, but not all, of the low-
volume threshold determinations, including as defined by dollar amount, 
beneficiary count or, if established, items and services. We intend to 
revisit this policy in future rulemaking and are seeking comment on 
methods to implement this policy in a low burden manner.

E. Payment Adjustments

    For the 2020 payment year based on Advanced APM participation in 
2018 performance period, we estimated that approximately 185,000 to 
250,000 clinicians will become QPs, and therefore, be excluded from the 
MIPS reporting requirements and payment adjustment, and qualify for a 
lump sum APM incentive payment equal to 5 percent of their estimated 
aggregate payment amounts for covered professional services in the 
preceding year. We estimate that the total lump sum APM incentive 
payments will be between approximately $675 million and $900 million 
for the 2020 Quality Payment Program payment year. This expected growth 
in QPs between the first and second year of the program is due in part 
to reopening of CPC+ and Next Generation ACO for 2018, and the Medicare 
ACO Track 1+ Model which is projected to have a large number of 
participants, with a large majority reaching QP status.
    Under the policies in this final rule with comment period, and for 
purposes of the Regulatory Impact Analysis, we estimate that 
approximately 622,000 eligible clinicians will be subject to MIPS 
reporting requirements and payment adjustments in the 2018 MIPS 
performance period. However, this number may vary depending on the 
number of eligible clinicians excluded from MIPS based on their status 
as QPs or Partial QPs. After restricting the population to eligible 
clinician types who are not newly enrolled, we believe the increase in 
the low-volume threshold is expected to exclude 540,000 clinicians who 
do not exceed the low-volume threshold. In the 2020 MIPS payment year, 
MIPS payment adjustments will be applied based on MIPS eligible 
clinicians' performance on specified measures and activities within 
four integrated performance categories.
    Assuming that 90 percent of MIPS eligible clinicians of all 
practice sizes participate in MIPS, we estimate that MIPS payment 
adjustments will be approximately equally distributed between negative 
MIPS payment adjustments of $118 million and positive MIPS payment 
adjustments of $118 million to MIPS eligible clinicians, as required by 
the statute to ensure budget neutrality. Positive MIPS payment 
adjustments will also include up to an additional $500 million for 
exceptional performance to MIPS eligible clinicians whose final score 
meets or exceeds the additional performance threshold of 70 points. 
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 will change based on the final population of 
MIPS eligible clinicians for CY 2020 and the distribution of scores 
under the program. We believe that starting with these modest initial 
MIPS payment adjustments is in the long-term best interest of 
maximizing participation and starting the Quality Payment Program off 
on the right foot, even if it limits the magnitude of MIPS positive 
adjustments during the 2018 MIPS performance period. The increased 
availability of Advanced APM opportunities, including through Medical 
Home models, also provides earlier avenues to earn APM incentive 
payments for those eligible clinicians who choose to participate.

F. Benefits and Costs of the Final Rule With Comment Period

    We quantify several costs associated with this rule. We estimate 
that this final rule with comment period will result in approximately 
$694 million in collection of information-related burden. We estimate 
that the incremental collection of information-related burden 
associated with this final rule with comment period is a reduction of 
approximately $13.9 million relative to the estimated burden of 
continuing the policies the CY 2017 Quality Payment Program final rule, 
which is $708 million. We also estimate regulatory review costs of $2.2 
million for this final rule with comment period. We estimate that 
federal expenditures will include $118 million in revenue neutral 
payment adjustments and $500 million for exceptional performance 
payments. Additional federal expenditures include approximately $675-
$900 million in APM incentive payments to QPs.

G. Automatic Extreme and Uncontrollable Circumstance Policy Interim 
Final Rule With Comment Period

    In order to account for Hurricanes Harvey, Irma, and Maria and 
other disasters that have occurred or might occur during the 2017 MIPS 
performance period, we are establishing in an interim final rule with 
comment period an automatic extreme and uncontrollable circumstance 
policy for the quality, improvement activities, and advancing care 
information performance categories for the 2017 MIPS performance 
period. We believe the automatic extreme and uncontrollable 
circumstance policy will reduce clinician burden during a catastrophic 
time and will also align with Medicare policies in other programs such 
as the Hospital IQR Program. Under this policy, we will apply the 
extreme and uncontrollable circumstance policies for the MIPS 
performance categories to individual MIPS eligible clinicians for the 
2017 MIPS performance period without requiring a MIPS eligible 
clinician to submit an application when we determine a triggering 
event, such as a hurricane, has occurred and the clinician is in an 
affected area. We will automatically weight the quality, improvement 
activities, and advancing care information performance categories at 
zero percent of the final score, resulting in a final score equal to 
the performance threshold, unless the MIPS eligible clinician submits 
MIPS data which we would then score on a performance-category-by-
performance-category-basis, like all other MIPS eligible clinicians. We 
are not making any changes to the APM scoring standard policies that 
apply in 2017 for participants in MIPS APMs. We are waiving notice and 
comment and adopting this policy on an interim final basis due to the 
urgency of providing relief for MIPS eligible clinicians impacted by 
recent natural disasters during the 2017 MIPS performance period.

H. Stakeholder Input

    In developing this final rule with comment period, we sought 
feedback from stakeholders and the public throughout the process, 
including in the CY 2018 Quality Payment Program proposed rule, CY 2017 
Quality Payment Program final rule with comment period, listening 
sessions, webinars, and other listening venues. We received a high 
degree of interest

[[Page 53578]]

from a broad spectrum of stakeholders. We thank our many commenters and 
acknowledge their valued input throughout the rulemaking process. We 
summarize and respond to comments on our proposals in the appropriate 
sections of this final rule with comment period, though we are not able 
to address all comments or all issues that all commenters raised due to 
the volume of comments and feedback. Specifically, due to the volume of 
comments we have not summarized feedback from commenters on items we 
solicited feedback on for future rulemaking purposes. However, in 
general, commenters continue to be supportive as we continue 
implementation of the Quality Payment Program and maintain optimism as 
we move from FFS Medicare payment towards a payment structure focused 
on the quality and value of care. Public support for our proposed 
approach and policies in the proposed rule, which many were finalized, 
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. Additionally we note that we 
received a number of comments from stakeholders in regards to the 
application of MIPS to certain Part B drugs. Additional guidance on the 
applicability of MIPS to Part B drugs can be found on our Web site at 
qpp.cms.gov.
    We thank stakeholders again for their responses throughout our 
process, in various venues, including comments on 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 
(herein referred to as the MIPS and APMs RFI) (80 FR 59102 through 
59113) and the CY 2017 Quality Payment Program final rule (81 FR 77008 
through 77831). 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.
    We will continue to offer help so clinicians can be successful in 
the program and make informed decisions about how to participate. You 
can find out more about the help that's available at qpp.cms.gov, which 
has many free and customized resources, or by calling 1-866-288-8292. 
As with the policy decisions, stakeholder feedback is essential to the 
development of educational resources as well. We look forward to your 
feedback on existing or the need for new resources.

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

    The following is a summary of the proposed provisions in the 
``Medicare Program; CY 2018 Updates to the Quality Payment Program'' 
proposed rule (82 FR 30010-30500) (hereinafter referred to as the ``CY 
2018 Quality Payment Program proposed rule.'' In this section, we also 
provide summaries of the public comments and our responses.

A. Introduction

    The Quality Payment Program, authorized by the Medicare Access and 
CHIP Reauthorization Act of 2015 (MACRA) is a new approach for 
reforming care across the health care delivery system for eligible 
clinicians. Under the Quality Payment Program, eligible clinicians can 
participate via one of two pathways: Advanced Alternative Payment 
Models (APMs); or the Merit-based Incentive Payment System (MIPS). We 
began implementing the Quality Payment Program through rulemaking for 
calendar year (CY) 2017. This rule provides updates for the second and 
future years of the Quality Payment Program.

B. Definitions

    At Sec.  414.1305, subpart O, we define the following terms:

 Ambulatory Surgical Center (ASC)-based MIPS eligible 
clinician.
 CMS Multi-Payer Model.
 Facility-based MIPS eligible clinician.
 Full TIN APM.
 Improvement Scoring.
 Other MIPS APM.
 Solo practitioner.
 Virtual group.

    We revise the definitions of the following terms:

 Affiliated practitioner.
 APM Entity.
 Attributed beneficiary.
 Certified Electronic Health Record Technology (CEHRT).
 Final Score.
 Hospital-based MIPS eligible clinician.
 Low-volume threshold.
 Medicaid APM.
 Non-patient facing MIPS eligible clinician.
 Other Payer Advanced APM.
 Rural areas.
 Small practice.

    We remove the following terms:

 Advanced APM Entity.

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

C. MIPS Program Details

1. MIPS Eligible Clinicians
a. Definition of a MIPS Eligible Clinician
    In the CY 2017 Quality Payment Program final rule (81 FR77040 
through 77041), we defined at Sec.  414.1305 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 
established at Sec.  414.1310(b) and (c) that the following are 
excluded from this definition per the statutory exclusions defined in 
section 1848(q)(1)(C)(ii) and (v) of the Act: (1) QPs; (2) Partial QPs 
who choose not to report on applicable measures and activities that are 
required to be reported under MIPS for any given performance period in 
a year; (3) low-volume threshold eligible clinicians; and (4) new 
Medicare-enrolled eligible clinicians. In accordance with sections 
1848(q)(1)(A) and (q)(1)(C)(vi) of the Act, we established at Sec.  
414.1310(b)(2) that eligible clinicians (as defined at Sec.  414.1305) 
who are not MIPS eligible clinicians have the option to voluntarily 
report measures and activities for MIPS. Additionally, we established 
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 eligible 
clinicians who are not MIPS eligible clinicians, as described in Sec.  
414.1310(b) and (c), including those who voluntarily report on 
applicable measures and activities specified under MIPS.
    In the CY 2017 Quality Payment Program final rule (81 FR 77340), 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 payment adjustment at the TIN/NPI level. We have 
received requests for additional clarifications on which specific Part 
B services are subject to the MIPS payment adjustment, as well as which 
Part B services are included for eligibility determinations. We note 
that

[[Page 53579]]

when Part B items or services are furnished by suppliers that are also 
MIPS eligible clinicians, there may be circumstances in which it is not 
operationally feasible for us to attribute those items or services to a 
MIPS eligible clinician at an NPI level in order to include them for 
purposes of applying the MIPS payment adjustment or making eligibility 
determinations.
    To further clarify, there are circumstances that involve Part B 
prescription drugs and durable medical equipment (DME) where the 
supplier may also be a MIPS eligible clinician. In the case of a MIPS 
eligible clinician who furnishes a Part B covered item or service, such 
as prescribing Part B drugs that are dispensed, administered, and 
billed by a supplier that is a MIPS eligible clinician, or ordering DME 
that is administered and billed by a supplier that is a MIPS eligible 
clinician, 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 the 
MIPS payment adjustment or making eligibility determinations. To the 
extent that it is not operationally feasible for us to do so, such 
items or services would not be included for purposes of applying the 
MIPS payment adjustment or making eligibility determinations. However, 
for those billed Medicare Part B allowed charges that we are able to 
associate with a MIPS eligible clinician at an NPI level, such items 
and services would be included for purposes of applying the MIPS 
payment adjustment or making eligibility determinations.
b. Groups
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77088 through 77831), we indicated that we will assess performance 
either for individual MIPS eligible clinicians or for groups. We 
defined a group at Sec.  414.1305 as a single Taxpayer Identification 
Number (TIN) with two or more eligible clinicians (including at least 
one MIPS eligible clinician), as identified by their individual NPI, 
who have reassigned their Medicare billing rights to the TIN. We 
recognize that MIPS eligible clinicians participating in MIPS may be 
part of a TIN that has one portion of its NPIs participating in MIPS 
according to the generally applicable scoring criteria while the 
remaining portion of its NPIs is participating in a MIPS APM or an 
Advanced APM according to the MIPS APM scoring standard. In the CY 2017 
Quality Payment Program final rule (81 FR 77058), we noted that except 
for groups containing APM participants, we are not permitting groups to 
``split'' TINs if they choose to participate in MIPS as a group. Thus, 
we would like to clarify that we consider a group to be either an 
entire single TIN or portion of a TIN that: (1) Is participating in 
MIPS according to the generally applicable scoring criteria while the 
remaining portion of the TIN is participating in a MIPS APM or an 
Advanced APM according to the MIPS APM scoring standard; and (2) 
chooses to participate in MIPS at the group level. We also defined an 
APM Entity group at Sec.  414.1305 as a group of eligible clinicians 
participating in an APM Entity, as identified by a combination of the 
APM identifier, APM Entity identifier, TIN, and NPI for each 
participating eligible clinician.
c. Small Practices
    In the CY 2017 Quality Payment Program final rule (81 FR 77188), we 
defined the term small practices at Sec.  414.1305 as practices 
consisting of 15 or fewer clinicians and solo practitioners. However, 
it has come to our attention that there is inconsistency between the 
proposed definition of a solo practitioner discussed in section 
II.C.4.b. of this final rule with comment period and the established 
definition of a small practice. Therefore, to resolve this 
inconsistency and ensure greater consistency with established MIPS 
terminology, we are modifying the definition of a small practice at 
Sec.  414.1305 to mean a practice consisting of 15 or fewer eligible 
clinicians. This modification is not intended to substantively change 
the definition of a small practice. In section II.C.4.d. of this final 
rule with comment period, we discuss how small practice status would 
apply to virtual groups. Also, in the final rule with comment period, 
we noted that we would not make an eligibility determination regarding 
the size of small practices, but indicated that small practices would 
attest to the size of their group practice (81 FR 77057). However, we 
have since realized that our system needs to account for small practice 
size in advance of a performance period for operational purposes 
relating to assessing and scoring the improvement activities 
performance category, determining hardship exceptions for small 
practices, calculating the small practice bonus for the final score, 
and identifying small practices eligible for technical assistance. As a 
result, we believe it is critical to modify the way in which small 
practice size would be determined. To make eligibility determinations 
regarding the size of small practices for performance periods occurring 
in 2018 and future years, we proposed that we would determine the size 
of small practices as described in this section of the final rule with 
comment period (82 FR 30020). As noted in the CY 2017 Quality Payment 
Program final rule, the size of a group (including a small practice) 
would be determined before exclusions are applied (81 FR 77057). We 
note that group size determinations are based on the number of NPIs 
associated with a TIN, which would include eligible clinicians (NPIs) 
who may be excluded from MIPS participation and do not meet the 
definition of a MIPS eligible clinician.
    To make eligibility determinations regarding the size of small 
practices for performance periods occurring in 2018 and future years, 
we proposed that we would determine the size of small practices by 
utilizing claims data (82 FR 30020). For purposes of this section, we 
are coining the term ``small practice size determination period'' to 
mean a 12-month assessment period, which consists of an analysis of 
claims data that spans from the last 4 months of a calendar year 2 
years prior to the performance period followed by the first 8 months of 
the next calendar year and includes a 30-day claims run out. This would 
allow us to inform small practices of their status near the beginning 
of the performance period as it pertains to eligibility relating to 
technical assistance, applicable improvement activities criteria, the 
proposed hardship exception for small practices under the advancing 
care information performance category, and the proposed small practice 
bonus for the final score.
    Thus, for purposes of performance periods occurring in 2018 and the 
2020 MIPS payment year, we would identify small practices based on 12 
months of data starting from September 1, 2016 to August 31, 2017. We 
would not change an eligibility determination regarding the size of a 
small practice once the determination is made for a given performance 
period and MIPS payment year. We recognize that there may be 
circumstances in which the small practice size determinations made do 
not reflect the real-time size of such practices. We considered two 
options that could address such potential discrepancies. One option 
would include an expansion of the proposed small practice size 
determination period to 24 months with two 12-month segments of data 
analysis (before and during the performance period), in which we would 
conduct a second analysis of claims data during the performance period. 
Such an expanded

[[Page 53580]]

determination period may better capture the real-time size of small 
practices, but determinations made during the performance period 
prevent our system from being able to account for the assessment and 
scoring of the improvement activities performance category and 
identification of small practices eligible for technical assistance 
prior to the performance period. Specifically, our system needs to 
capture small practice determinations in advance of the performance 
period in order for the system to reflect the applicable requirements 
for the improvement activities performance category and when a small 
practice bonus would be applied. A second option would include an 
attestation component, in which a small practice that was not 
identified as a small practice during the small practice size 
determination period would be able to attest to the size of their group 
practice prior to the performance period. However, this second option 
would require us to develop several operational improvements, such as a 
manual process or system that would provide an attestation mechanism 
for small practices, and a verification process to ensure that only 
small practices are identified as eligible for technical assistance. 
Since individual MIPS eligible clinicians and groups are not required 
to register to participate in MIPS (except for groups utilizing the CMS 
Web Interface for the Quality Payment Program or administering the 
CAHPS for MIPS survey), requiring small practices to attest to the size 
of their group practice prior to the performance period could increase 
burden on individual MIPS eligible clinicians and groups that are not 
already utilizing the CMS Web Interface for the Quality Payment Program 
or administering the CAHPS for MIPS survey. We solicited public comment 
on the proposal regarding how we would determine small practice size.
    The following is a summary of the public comments received on the 
``Small Practices'' proposal and our responses:
    Comment: Several commenters supported using historical claims data 
to make a small practice size determination. One commenter also noted 
support for the definition of a small practice using the number of NPIs 
associated with a TIN.
    Response: We are finalizing that we will utilize a 12-month 
assessment period, which consists of an analysis of claims data that 
spans from the last 4 months of a calendar year 2 years prior to the 
performance period followed by the first 8 months of the next calendar 
year and includes a 30-day claims run out for the small practice size 
determination.
    Comment: Several commenters supported the proposal to notify small 
practices of their status near the beginning of the performance period 
so that practices can plan accordingly.
    Response: We are finalizing that we will utilize a 12-month 
assessment period, which consists of an analysis of claims data that 
spans from the last 4 months of a calendar year 2 years prior to the 
performance period followed by the first 8 months of the next calendar 
year and includes a 30-day claims run out for the small practice size 
determination. We anticipate providing MIPS eligible clinicians with 
their small practice size determination by Spring 2018, for the 
applicable 2018 performance period.
    Comment: Several commenters recommended that practices be allowed 
to attest the size of their practice if they are not identified during 
the small practice size determination period. Specifically, a few 
commenters expressed concern that utilizing claims data will result in 
practices learning of their small practice status too close to the 
start of the performance period. A few commenters recommended that we 
should rely on attestation alone, and expressed concern that claims 
data will not provide a reliable, real-time determination of practice 
size. Another commenter specifically recommended that practices be 
required to attest 180 days before the close of the performance period 
so that practices can accurately predict their status. One commenter 
recommended that we validate practice size for groups attesting as 
small using recent claims data. One commenter recommended utilizing a 
claims determination process as well as attestation, and using 
whichever method yields a smaller practice size.
    Response: Regarding the various commenters that provided different 
methods for validating practice size, including: Attesting as small 
using recent claims data; utilizing an 180 days attestation period; or 
utilizing a claims determination process as well as attestation, we 
have considered various approaches and have determined that the most 
straightforward approach which provides the lowest burden to MIPS 
eligible clinicians is the utilization of claims data. By utilizing 
claims data, we can apply the status of a small practice accurately 
without requiring clinicians to take a separate action and attest to 
being a small practice. Therefore, we are finalizing that we will 
utilize a 12-month assessment period, which consists of an analysis of 
claims data that spans from the last 4 months of a calendar year 2 
years prior to the performance period followed by the first 8 months of 
the next calendar year and includes a 30-day claims run out for the 
small practice size determination. We anticipate providing MIPS 
eligible clinicians with their small practice size determination by 
Spring 2018, for the applicable 2018 performance period.
    As discussed in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30020), there are operational barriers with allowing groups to 
attest to their size. Specifically, since individual MIPS eligible 
clinicians and groups are not required to register to participate in 
MIPS (except for groups utilizing the CMS Web Interface for the Quality 
Payment Program or administering the CAHPS for MIPS survey), requiring 
small practices to attest to the size of their group practice prior to 
the performance period could increase burden on individual MIPS 
eligible clinicians and groups. In addition, attestation would require 
us to develop several operational improvements, such as a manual 
process or system that would provide an attestation mechanism for small 
practices, and a verification process to ensure that only small 
practices are identified as eligible for technical assistance. We 
believe utilizing claims data will support most eligibility 
determinations because we consider it a reliable source of how a MIPS 
eligible clinician or group interacts with Medicare.
    Comment: One commenter expressed concern that using performance 
period data or an attestation portal as a second step in the small 
practice identification process does not provide practices with 
adequate advanced notice of their practice size determination and could 
limit their ability to access small practice support services.
    Response: We are finalizing that we will utilize a 12-month 
assessment period, which consists of an analysis of claims data that 
spans from the last 4 months of a calendar year 2 years prior to the 
performance period followed by the first 8 months of the next calendar 
year and includes a 30-day claims run out for the small practice size 
determination. This proposed modification of the claims run out period 
from 60 days to 30 days increases the speed of delivery for 
communication and creation of the file using claims data. In addition, 
using the 30-day claims run out allows us to inform small practices of 
their determination as soon as technically possible, as it pertains to 
eligibility relating to technical assistance, applicable improvement

[[Page 53581]]

activities criteria, the proposed hardship exception for small 
practices under the advancing care information performance category, 
and the proposed small practice bonus for the final score. As a result, 
we do not believe clinicians' ability to access small practice support 
services will be limited.
    Comment: A few commenters recommended that we should not allow 
practices to attest that they are small practices. Specifically, one 
commenter expressed concern that practices may mistakenly expect to be 
identified as small based on their number of MIPS eligible clinicians 
and attest incorrectly.
    Response: We acknowledge and agree with the commenters' concern. We 
have considered various approaches and have determined that the most 
straightforward and best representation of small practice size 
determination is the utilization of claims data. Therefore, we are 
finalizing that we will utilize a 12-month assessment period, which 
consists of an analysis of claims data that spans from the last 4 
months of a calendar year 2 years prior to the performance period 
followed by the first 8 months of the next calendar year and includes a 
30-day claims run out for the small practice size determination.
    Comment: Several commenters did not support the previously 
finalized definition of small practices as practices consisting of 15 
or fewer clinicians and solo practitioners. One commenter recommended 
that we modify the definition of small practices to include those that 
are similar in challenges and structure, but that may include more than 
15 clinicians. The commenter noted that several small practices may be 
loosely tied together under the same TIN but may function as small 
practices without the benefit of shared organizational and 
administrative resources. The commenter recommended that we assess the 
number of clinicians at a physical practice site to determine small 
practice status and ability to join a virtual group. Several commenters 
believed that we should define small practices based on the number of 
MIPS eligible clinicians, not eligible clinicians. A few commenters 
supported defining small practices based on the number of full-time 
equivalent employees, arguing that rural and HPSAs use different 
staffing arrangements to fully staff their practices.
    Response: Section 1848(q)(2)(B)(iii) of the Act defines small 
practices as consisting of 15 or fewer professionals. We previously 
defined small practices at Sec.  414.1305 as practices consisting of 15 
or fewer clinicians and solo practitioners in order to include both 
MIPS eligible clinicians and eligible clinicians, such as those in 
APMs. As discussed above, we are modifying the definition of a small 
practice at Sec.  414.1305 to mean a practice consisting of 15 or fewer 
eligible clinicians. This modification is not intended to substantively 
change the definition of a small practice. In response to the 
suggestions that we assess the number of clinicians at a physical 
practice site to determine small practice status, or make the small 
practice assessment based on the number of full-time equivalent 
employees, we acknowledge that some practices may be structured in this 
manner; however, we do not currently have a reliable method of making a 
determination that does not require a separate action from such 
practices, such as attestation or submission of supporting 
documentation to verify these statuses. Rather, we believe the approach 
of simply counting the NPIs (clinicians) that are associated with a TIN 
provides a simple method for all stakeholders to understand.
    Final Action: After consideration of the public comments, we are 
finalizing that we will utilize a 12-month assessment period, which 
consists of an analysis of claims data that spans from the last 4 
months of a calendar year 2 years prior to the performance period 
followed by the first 8 months of the next calendar year and includes a 
30-day claims run out for the small practice size determination. In 
addition, as discussed above, we are modifying the definition of a 
small practice at Sec.  414.1305 to mean a practice consisting of 15 or 
fewer eligible clinicians. This modification is not intended to 
substantively change the definition of a small practice. Finally, we 
refer readers to section II.C.4.b. of this final rule with comment 
period for a discussion of the definition of a solo practitioner.
d. Rural Area and Health Professional Shortage Area Practices
    In the CY 2017 Quality Payment Program final rule, we defined rural 
areas at Sec.  414.1305 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; and Health 
Professional Shortage Areas (HPSAs) at Sec.  414.1305 as areas 
designated under section 332(a)(1)(A) of the Public Health Service Act. 
For technical accuracy purposes, we proposed to remove the language 
``clinicians in'' as clinicians are not technically part of a ZIP code 
and modify the definition of a rural areas at Sec.  414.1305 as ZIP 
codes designated as rural, using the most recent Health Resources and 
Services Administration (HRSA) Area Health Resource File data set 
available.
    We recognize that there are cases in which an individual MIPS 
eligible clinician (including a solo practitioner) or a group may have 
multiple practice sites associated with its TIN and as a result, it is 
critical for us to outline the application of rural area and HPSA 
practice designations to such practices. For performance periods 
occurring in 2017, we consider an individual MIPS eligible clinician or 
a group with at least one practice site under its TIN in a ZIP code 
designated as a rural area or HPSA to be a rural area or HPSA practice. 
For performance periods occurring in 2018 and future years, we believe 
that a higher threshold than one practice within a TIN is necessary to 
designate an individual MIPS eligible clinician, a group, or a virtual 
group as a rural or HPSA practice. We recognize that the establishment 
of a higher threshold starting in 2018 would more appropriately 
identify groups and virtual groups with multiple practices under a 
group's TIN or TINs that are part of a virtual group as rural or HPSA 
practice and ensure that groups and virtual groups are assessed and 
scored according to requirements that are applicable and appropriate. 
We note that in the CY 2017 Quality Payment Program final rule (81 FR 
77048 through 77049), we defined a non-patient facing MIPS eligible 
clinician at Sec.  414.1305 as including 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 refer readers to 
section II.C.1.e. of this final rule with comment period for our policy 
to modify the definition of a non-patient facing MIPS eligible 
clinician. We believe that using a similar threshold for applying the 
rural and HPSA designation to an individual MIPS eligible clinician, a 
group, or virtual group with multiple practices under its TIN or TINs 
within a virtual group will add consistency for such practices across 
the MIPS as it pertains to groups and virtual groups obtaining such 
statuses. We also believe that establishing a 75 percent threshold 
renders an adequate representation of a group or virtual group where a 
significant portion of a group or a virtual group is identified as 
having such status. Therefore, for performance periods occurring in 
2018 and future years, we proposed that an individual

[[Page 53582]]

MIPS eligible clinician, a group, or a virtual group with multiple 
practices under its TIN or TINs within a virtual group would be 
designated as a rural or HPSA practice if more than 75 percent of NPIs 
billing under the individual MIPS eligible clinician or group's TIN or 
within a virtual group, as applicable, are designated in a ZIP code as 
a rural area or HPSA (82 FR 30020 through 30021).
    The following is a summary of the public comments received on the 
``Rural Area and Health Professional Shortage Area Practices'' 
proposals and our responses:
    Comment: Several commenters supported the proposals to modify the 
definition of rural areas as ZIP codes designated as rural and a rural 
group when more than 75 percent of NPIs billing under the individual 
MIPS eligible clinician or group's TIN or within a virtual group, as 
applicable, are designated in a ZIP code as a rural area or HPSA. 
Another commenter recommended that we conduct further analysis on those 
clinicians who thought they qualified as a rural area or HPSA practice 
but did not meet the 75 percent threshold.
    Response: We are finalizing that the definition of a rural areas at 
Sec.  414.1305 as ZIP codes designated as rural, using the most recent 
Health Resources and Services Administration (HRSA) Area Health 
Resource File data set available. In addition, we are finalizing that 
for performance periods occurring in 2018 and future years, that an 
individual MIPS eligible clinician, a group, or a virtual group with 
multiple practices under its TIN or TINs within a virtual group would 
be designated as a rural or HPSA practice if more than 75 percent of 
NPIs billing under the individual MIPS eligible clinician or group's 
TIN or within a virtual group, as applicable, are designated in a ZIP 
code as a rural area or HPSA. In regard to the suggestion that we 
conduct further analysis on those clinicians who thought they qualified 
as a rural area or HPSA practice but did not meet the 75 percent 
threshold, we would encourage those stakeholders to contact our Quality 
Payment Program Service Center which may be reached at 1-866-288-8292 
(TTY 1-877-715-6222), available Monday through Friday, 8:00 a.m.-8:00 
p.m. Eastern Time or via email at [email protected].
    Comment: One commenter recommended we further analyze the 
characteristics of practices currently defined as rural or HPSA to 
identify practices that may be inappropriately classified.
    Response: We believe that establishing a 75 percent threshold more 
appropriately identifies groups and virtual groups with multiple 
practices under a group's TIN or TINs that are part of a virtual group 
as rural or HPSA practices and ensure that groups and virtual groups 
are assessed and scored according to requirements that are applicable 
and appropriate. We will take the suggestions for further analysis on 
the characteristics of practices currently defined as rural or HPSA to 
identify practices that may be inappropriately classified into 
consideration in future rulemaking as necessary.
    Comment: Several commenters did not support the proposed definition 
of rural areas and did not support the proposed group definition of 
rural and HPSA practice. One commenter did not support the use of ZIP 
codes as a reliable indicator of rural status as some clinicians have 
multiple sites inside and outside of rural areas. A few commenters 
recommended that we not adopt the policy that a group be considered 
rural if more than 75 percent of NPIs billing under the TIN are 
designated in a ZIP code as rural or HPSA because it would overly limit 
the number of rural group practices. Of these commenters, two 
recommended using 50 percent as a threshold, and one commenter 
recommended a gradual transition using the 2017 threshold for the 2018 
MIPS performance period and thresholds of 25 percent, 50 percent, and 
75 percent in performance periods occurring in 2019, 2020, and 2021, 
respectively. A few commenters believed that expanding the number of 
clinicians in rural or HPSA groups would hamper the ability of those 
practices to participate fully in the transition to value-based care 
and increase disparities between urban and rural care. One commenter 
stated that the status of rural or HPSA should be assigned to an 
individual but not be assigned to a group.
    Response: We are finalizing that an individual MIPS eligible 
clinician, a group, or a virtual group with multiple practices under 
its TIN or TINs within a virtual group would be designated as a rural 
or HPSA practice if more than 75 percent of NPIs billing under the 
individual MIPS eligible clinician or group's TIN or within a virtual 
group, as applicable, are designated in a ZIP code as a rural area or 
HPSA. We do not believe establishing a 75 percent threshold would 
overly limit the number of rural group practices, nor hamper their 
ability to participate fully in the transition to value-based care, or 
increase disparities between urban and rural care. In response to the 
various threshold recommendations, we believe that the 75 percent 
threshold provides adequate representation of the group, and it also 
aligns with our definition of a non-patient facing group, which 
provides consistency across the program. We believe rural and HPSA 
status should be assigned to groups because we believe those clinicians 
that are in a rural or HPSA area and choose to participate in MIPS as 
part of a group, should receive the benefit of those statuses, 
regardless of their chosen participation mechanism. In regards to the 
commenter who did not support the use of ZIP codes as a reliable 
indicator of rural status due to clinicians practicing at multiple 
sites, we disagree. We believe that utilizing ZIP codes designated as 
rural is an appropriate indicator of rural status. We further note that 
if a clinician practices at multiple sites that have different TINs, 
each TIN would have a separate rural analysis applied for that 
particular site (TIN).
    Final Action: After consideration of the public comments, we are 
finalizing the definition of rural areas at Sec.  414.1305 as ZIP codes 
designated as rural, using the most recent Health Resources and 
Services Administration (HRSA) Area Health Resource File data set 
available. In addition, we are finalizing that for performance periods 
occurring in 2018 and future years, that an individual MIPS eligible 
clinician, a group, or a virtual group with multiple practices under 
its TIN or TINs within a virtual group would be designated as a rural 
or HPSA practice if more than 75 percent of NPIs billing under the 
individual MIPS eligible clinician or group's TIN or within a virtual 
group, as applicable, are designated in a ZIP code as a rural area or 
HPSA.
e. 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

[[Page 53583]]

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.C.6.f. of this final rule with comment 
period for the discussion regarding how we address performance category 
weighting for MIPS eligible clinicians for whom no measures or 
activities are applicable and available in a given performance 
category.
    In the CY 2017 Quality Payment Program final rule (81 FR 77048 
through 77049), we defined 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. In order to account 
for the formation of virtual groups starting in the 2018 performance 
year and how non-patient facing determinations would apply to virtual 
groups, we need to modify the definition of a non-patient facing MIPS 
eligible clinician. Therefore, for performance periods occurring in 
2018 and future years, we proposed to modify the definition of a non-
patient facing MIPS eligible clinician at Sec.  414.1305 to mean 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 or virtual group provided that more than 75 percent 
of the NPIs billing under the group's TIN or within a virtual group, as 
applicable, meet the definition of a non-patient facing individual MIPS 
eligible clinician during the non-patient facing determination period 
(82 FR 30021).
    We considered a patient-facing encounter to be an instance in which 
the individual 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 published the list of patient-
facing encounter codes for performance periods occurring in 2017 at 
qpp.cms.gov/resources/education. We intend to publish the list of 
patient-facing encounter codes for performance periods occurring in 
2018 at qpp.cms.gov by the end of 2017. The list of patient-facing 
encounter codes is used to determine the non-patient facing status of 
MIPS eligible clinicians.
    The list of patient-facing encounter codes includes two general 
categories of codes: Evaluation and Management (E&M) codes; and 
Surgical and Procedural codes. E&M codes capture clinician-patient 
encounters that occur in a variety of care settings, including office 
or other outpatient settings, hospital inpatient settings, emergency 
departments, and nursing facilities, in which clinicians utilize 
information provided by patients regarding history, present illness, 
and symptoms to determine the type of assessments to conduct. 
Assessments are conducted on the affected body area(s) or organ 
system(s) for clinicians to make medical decisions that establish a 
diagnosis or select a management option(s).
    Surgical and Procedural codes capture clinician-patient encounters 
that involve procedures, surgeries, and other medical services 
conducted by clinicians to treat medical conditions. In the case of 
many of these services, evaluation and management work is included in 
the payment for the single code instead of separately reported. 
Patient-facing encounter codes from both of these categories describe 
direct services furnished by eligible clinicians with impact on patient 
safety, quality of care, and health outcomes.
    For purposes of the non-patient facing policies under MIPS, the 
utilization of E&M codes and Surgical and Procedural codes allows for 
accurate identification of patient-facing encounters, and thus, 
accurate eligibility determinations regarding non-patient facing 
status. As a result, MIPS eligible clinicians considered non-patient 
facing are able to prepare to meet requirements applicable to non-
patient facing MIPS eligible clinicians. We proposed to continue 
applying these policies for purposes of the 2020 MIPS payment year and 
future years (82 FR 30021).
    As described in the CY 2017 Quality Payment Program final rule, we 
established the non-patient facing determination period for purposes of 
identifying non-patient facing MIPS eligible clinicians in advance of 
the performance period and during the performance period using 
historical and performance period claims data. This eligibility 
determination process allows us to begin identifying non-patient facing 
MIPS eligible clinicians prior to or shortly after the start of the 
performance period. The non-patient facing determination period is 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 spans from the 
last 4 months of a calendar year 2 years prior to the performance 
period followed by the first 8 months of the next calendar year and 
includes a 60-day claims run out, which allows us to inform individual 
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 spans 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 includes a 60-day 
claims run out, which will allow us to inform additional individual 
MIPS eligible clinicians and groups of their non-patient status during 
the performance period.
    However, based on our analysis of data from the initial segment of 
the non-patient facing determination period for performance periods 
occurring in 2017 (that is, data spanning from September 1, 2015 to 
August 31, 2016), we found that it may not be necessary to include a 
60-day claims run out since we could achieve a similar outcome for such 
eligibility determinations by utilizing a 30-day claims run out. In our 
comparison of data analysis results utilizing a 60-day claims run out 
versus a 30-day claims run out, there was a 1 percent decrease in data 
completeness (see Table 1 for data completeness regarding comparative 
analysis of a 60-day and 30-day claims run out). The small decrease in 
data completeness would not negatively impact individual MIPS eligible 
clinicians or groups regarding non-patient facing determinations. We 
believe that a 30-day claims run out would allow us to complete the 
analysis and provide such determinations in a more timely manner.

[[Page 53584]]



 Table 1--Percentages of Data Completeness for 60-Day and 30-Day Claims
                                 Run Out
------------------------------------------------------------------------
                                                 30-Day        60-Day
                Incurred year                  claims run    claims run
                                                  out *         out *
------------------------------------------------------------------------
2015........................................        97.1%         98.4%
------------------------------------------------------------------------
* Note: Completion rates are estimated and averaged at aggregated
  service categories and may not be applicable to subsets of these
  totals. For example, completion rates can vary by clinician due to
  claim processing practices, service mix, and post payment review
  activity. Completion rates vary from subsections of a calendar year;
  later portions of a given calendar year will be less complete than
  earlier ones. Completion rates vary due to variance in loading
  patterns due to technical, seasonal, policy, and legislative factors.
  Completion rates are a function of the incurred date used to process
  claims, and these factors will need to be updated if claims are
  processed on a claim from date or other methodology.

    For performance periods occurring in 2018 and future years, we 
proposed a modification to the non-patient facing determination period, 
in which 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 30-day claims run out; 
and 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 30-day 
claims run out (82 FR 30022). The proposal would only change the 
duration of the claims run out, not the 12-month timeframes used for 
the first and second segments of data analysis.
    For purposes of the 2020 MIPS payment year, we would 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, 2016, to August 31, 2017. To 
account for the identification of additional individual MIPS eligible 
clinicians and groups that may qualify as non-patient facing during 
performance periods occurring in 2018, we would conduct another 
eligibility determination analysis based on 12 months of data starting 
from September 1, 2017, to August 31, 2018.
    Similarly, for future years, we would 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 would 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 would continue to be considered non-patient 
facing for the duration of the performance period and MIPS payment year 
regardless of the results of the second eligibility determination 
analysis. We would 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.
    Additionally, in the CY 2017 Quality Payment Program final rule (81 
FR 77241), we established a policy regarding the re-weighting of the 
advancing care information performance category for non-patient facing 
MIPS eligible clinicians. Specifically, MIPS eligible clinicians who 
are considered to be non-patient facing will have their advancing care 
information performance category automatically reweighted to zero (81 
FR 77241). For groups that are considered to be non-patient facing 
(that is, 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 are finalizing in section II.C.7.b.(3) of this final rule with 
comment period to automatically reweight their advancing care 
information performance category to zero. We proposed to continue 
applying these policies for purposes of the 2020 MIPS payment year and 
future years.
    The following is a summary of the public comments received on the 
``Non-Patient Facing MIPS Eligible Clinicians'' proposals and our 
responses:
    Comment: Several commenters supported the policy to define non-
patient facing clinicians as individual eligible clinicians billing 100 
or fewer encounters, and group or virtual groups to be defined as non-
patient facing if more than 75 percent of eligible clinicians billing 
under the group meets the individual clinician definition. One 
commenter appreciated the flexibility we are demonstrating in 
considering the use of telehealth. Another commenter recommended we 
implement the same thresholds for rural and HPSA practices.
    Response: We are finalizing for performance periods occurring in 
2018 and future years that at Sec.  414.1305 non-patient facing MIPS 
eligible clinician means an individual MIPS eligible clinician that 
bills 100 or fewer patient-facing encounters (including Medicare 
telehealth services defined in section 1834(m) of the Act) during the 
non-patient facing determination period, and a group or virtual group 
provided that more than 75 percent of the NPIs billing under the 
group's TIN or within a virtual group, as applicable, meet the 
definition of a non-patient facing individual MIPS eligible clinician 
during the non-patient facing determination period.
    Comment: Several commenters did not support the proposed definition 
of non-patient facing as an individual MIPS eligible clinician that 
bills 100 or fewer patient-facing encounters 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. One commenter recommended that 
the definition of a non-patient facing clinician be defined at the 
individual clinician level and not be applied at a group level. Another 
commenter did not support applying the non-patient facing definition to 
pathologists using PECOS, but rather believed all pathologists should 
be automatically identified as non-patient facing.
    Response: We do not agree with the commenters who did not support 
the proposed definition of a non-patient facing MIPS eligible clinician 
at the individual or group level. We weighed several options when 
considering the appropriate definition of non-patient facing MIPS 
eligible clinicians and believe we have established an appropriate 
threshold that provides the most appropriate representation of a non-
patient facing MIPS eligible clinician. The 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-

[[Page 53585]]

patient facing services should be treated as a non-patient facing MIPS 
eligible clinician despite furnishing a small number of patient-facing 
services. This approach also allows us to determine if an individual 
clinician or a group of clinicians is non-patient facing. We believe 
that having the determination of non-patient facing available at the 
individual and group level provides further flexibilities for MIPS 
eligible clinicians on the options available to them for participation 
within the program. Our methodology used to identify non-patient facing 
MIPS eligible clinicians included a quantitative, comparative analysis 
of claims and HCPCS code data. We refer commenters to CY 2017 Quality 
Payment Program Final Rule (81 FR 77041 through 77049) for a full 
discussion on the logic for which clinicians are eligible to be non-
patient facing MIPS eligible clinicians. We agree and intend to provide 
the non-patient facing determination prior to the performance period 
following the non-patient facing determination period as discussed in 
section II.C.1.e. of this final rule with comment period. Regarding the 
comment disagreeing with applying the non-patient facing definition to 
pathologists using PECOS, we note that we are not utilizing PECOS for 
the non-patient facing determination, rather we utilize Part B claims 
data.
    Comment: Two commenters recommended that we release all patient-
facing codes through formal notice-and-comment rulemaking rather than 
subregulatory guidance.
    Response: In the CY 2018 Quality Payment Program proposed rule (82 
FR 30021), we noted that we consider a patient-facing encounter to be 
an instance in which the individual MIPS eligible clinician or group 
billed for items and services furnished such as general office visits, 
outpatient visits, and procedure codes under the PFS, and we described 
in detail two general categories of codes included in this list of 
codes, specifically, E&M codes and Surgical and Procedural codes, and 
our rationale for including these codes, which we proposed to continue 
applying for purposes of the 2020 MIPS payment year and future years. 
Therefore, we do not believe it is necessary to specify each individual 
code in notice-and-comment rulemaking. Moreover, we are unable to 
provide the patient-facing codes through the notice-and-comment 
rulemaking as the final list of Current Procedural Terminology (CPT) 
codes used to determine patient facing encounters are often not 
available in conjunction with the proposed and final rulemaking 
timelines. However, we intend to publish the patient-facing codes as 
close to when the final rule with comment period is issued as possible 
and prior to the start of the performance period. We will adopt any 
changes to this policy through future rulemaking as necessary.
    Comment: Several commenters supported the proposed policy on 
determination periods. The commenters agreed with the proposed policy 
to use 2 determination periods. A few commenters recommended that we 
notify MIPS eligible clinicians and groups prior to the start of the 
performance period by either including such information in the MIPS 
eligibility notifications sent to eligible clinicians or responding to 
MIPS eligible clinician or group requests for information. Two 
commenters recommended that we allow an appeal process or attestation 
by MIPS eligible clinicians for the non-patient facing designation.
    Response: We agree with the commenters regarding the non-patient 
facing determination period and that MIPS eligible clinicians should be 
notified prior to the performance period regarding their eligibility 
status. In the CY 2017 Quality Payment Program final rule (81 FR 77043 
through 77048), we established the non-patient facing determination 
period for purposes of identifying non-patient facing MIPS eligible 
clinicians in advance of the performance period and during the 
performance period using historical and performance period claims data. 
In addition, we would like to note that MIPS eligible clinicians may 
access the Quality Payment Program Web site at www.qpp.cms.gov and 
check if they are required to submit data to MIPS by entering their NPI 
into the online tool. In response to the comment regarding appeals for 
non-patient facing status, if a MIPS eligible clinician disagrees with 
the non-patient facing determination, we note that clinicians can 
contact the Quality Payment Program Service Center which may be reached 
at 1-866-288-8292 (TTY 1-877-715-6222), available Monday through 
Friday, 8:00 a.m.-8:00 p.m. Eastern Time or via email at 
[email protected]. If an error in the non-patient facing determination is 
discovered, we will update the MIPS eligible clinicians' status 
accordingly.
    Final Action: After consideration of the public comments, we are 
finalizing for performance periods occurring in 2018 and future years 
that at Sec.  414.1305 non-patient facing MIPS eligible clinician means 
an individual MIPS eligible clinician that bills 100 or fewer patient-
facing encounters (including Medicare telehealth services defined in 
section 1834(m) of the Act) during the non-patient facing determination 
period, and a group or virtual group provided that more than 75 percent 
of the NPIs billing under the group's TIN or within a virtual group, as 
applicable, meet the definition of a non-patient facing individual MIPS 
eligible clinician during the non-patient facing determination period. 
In addition, we are finalizing that for performance periods occurring 
in 2018 and future years that for purposes of non-patient facing MIPS 
eligible clinicians, we will utilize E&M codes and Surgical and 
Procedural codes for accurate identification of patient-facing 
encounters, and thus, accurate eligibility determinations regarding 
non-patient facing status. Further, we are finalizing that a patient-
facing encounter is considered to be an instance in which the 
individual MIPS eligible clinician or group billed for items and 
services furnished such as general office visits, outpatient visits, 
and procedure codes under the PFS. Finally, we are finalizing that for 
performance periods occurring in 2018 and future years, that for the 
non-patient facing determination period, in which 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 30-day claims run out; and 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 30-day claims run out.
f. MIPS Eligible Clinicians Who Practice in Critical Access Hospitals 
Billing Under Method II (Method II CAHs)
    In the CY 2017 Quality Payment Program final rule (81 FR 77049), we 
noted that 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, 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. As 
established in the CY 2017 Quality Payment Program final rule (81 FR 
77051), the MIPS payment adjustment will apply to Method II CAH 
payments

[[Page 53586]]

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 refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77049 through 77051) for our discussion of MIPS eligible 
clinicians who practice in Method II CAHs.
g. MIPS Eligible Clinicians Who Practice in Rural Health Clinics (RHCs) 
or Federally Qualified Health Centers (FQHCs)
    As established in the CY 2017 Quality Payment Program final rule 
(81 FR 77051 through 77053), services furnished by an eligible 
clinician under the RHC or FQHC methodology, will not be subject to the 
MIPS payments adjustments. As noted, 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.
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77051 through 77053) for our discussion of MIPS eligible 
clinicians who practice in RHCs or FQHCs.
h. MIPS Eligible Clinicians Who Practice in Ambulatory Surgical Centers 
(ASCs), Home Health Agencies (HHAs), Hospice, and Hospital Outpatient 
Departments (HOPDs)
    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 ASC, HHA, 
Hospice, and/or HOPD and the facility bills for those items and 
services (including prescription drugs) under the facility's all-
inclusive payment methodology or prospective payment system 
methodology, the MIPS adjustment would not apply to the facility 
payment itself. However, if a MIPS eligible clinician furnishes other 
items and services in an ASC, HHA, Hospice, and/or HOPD and bills for 
those items and services separately, such as under the PFS, the MIPS 
adjustment would apply to payments made for such items and services. 
Such items and services would also be considered for purposes of 
applying the low-volume threshold. Therefore, we proposed that services 
furnished by an eligible clinician that are payable under the ASC, HHA, 
Hospice, or HOPD methodology would not be subject to the MIPS payments 
adjustments (82 FR 30023). However, these eligible clinicians have the 
option to voluntarily report on applicable measures and activities for 
MIPS, in which case the data received would not be used to assess their 
performance for the purpose of the MIPS payment adjustment. We note 
that eligible clinicians who bill under both the PFS and one of these 
other billing methodologies (ASC, HHA, Hospice, and/or HOPD) may be 
required to participate in MIPS if they exceed the low-volume threshold 
and are otherwise eligible clinicians; in such case, the data reported 
would be used to determine their MIPS payment adjustment.
    The following is a summary of the public comments received on the 
``MIPS Eligible Clinicians Who Practice in ASCs, HHAs, HOPDs'' proposal 
and our responses:
    Comment: A few commenters agreed with the proposal that services 
furnished by an eligible clinician that are payable under the ASC, HHA, 
Hospice, or Outpatient payment methodology would not be subject to the 
MIPS payment adjustments.
    Response: We appreciate the commenters' support. We are finalizing 
that services furnished by an eligible clinician that are payable under 
the ASC, HHA, Hospice, or HOPD methodology will not be subject to the 
MIPS payments adjustments and that such data will not be utilized for 
MIPS eligibility purposes.
    Final Action: After consideration of the public comments, we are 
finalizing that services furnished by an eligible clinician that are 
payable under the ASC, HHA, Hospice, or HOPD methodology will not be 
subject to the MIPS payments adjustments and that such data will not be 
utilized for MIPS eligibility purposes, as proposed.
i. MIPS Eligible Clinician Identifiers
    As described in the CY 2017 Quality Payment Program final rule (81 
FR 77057), we established the use of multiple identifiers that allow 
MIPS eligible clinicians to be measured as an individual or 
collectively through a group's performance and that the same identifier 
be used for all four performance categories. While we have multiple 
identifiers for participation and performance, we established the use 
of a single identifier, TIN/NPI, for applying the MIPS payment 
adjustment, regardless of how the MIPS eligible clinician is assessed.
(1) Individual Identifiers
    As established in the CY 2017 Quality Payment Program final rule 
(81 FR 77058), we define a MIPS eligible clinician at Sec.  414.1305 to 
mean the use of 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 is considered a different 
MIPS eligible clinician, and MIPS performance is assessed separately 
for each TIN under which an individual bills.
(2) Group Identifiers for Performance
    As established in the CY 2017 Quality Payment Program final rule 
(81 FR 77059), we codified 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.
(3) APM Entity Group Identifiers for Performance
    As described in the CY 2017 Quality Payment Program final rule (81 
FR 77060), we established that each eligible clinician who is a 
participant of an APM Entity is identified by a unique APM participant 
identifier. The unique APM participant identifier is 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). We codified 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, TIN, and NPI for each participating eligible 
clinician.
2. Exclusions
a. New Medicare-Enrolled Eligible Clinician
    As established in the CY 2017 Quality Payment Program final rule 
(81 FR 77061 through 77062), we defined 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 
clinician group or under a different billing number or tax identifier. 
Additionally, we established

[[Page 53587]]

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. We established 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 used the term ``new Medicare-enrolled eligible clinician 
determination period'' to refer to the 12 months of a calendar year 
applicable to the performance period. During the new Medicare-enrolled 
eligible clinician determination period, we conduct eligibility 
determinations on a quarterly basis to the extent that is technically 
feasible to identify new Medicare-enrolled eligible clinicians that 
would be excluded from the requirement to participate in MIPS for the 
applicable performance period.
b. Qualifying APM Participant (QP) and Partial Qualifying APM 
Participant (Partial QP)
    In the CY 2017 Quality Payment Program final rule (81 FR 77062), we 
established at Sec.  414.1305 that a QP (as defined at Sec.  414.1305) 
is not a MIPS eligible clinician, and therefore, is excluded from MIPS. 
Also, we established that a Partial QP (as defined at Sec.  414.1305) 
who does not report on applicable measures and activities that are 
required to be reported under MIPS for any given performance period in 
a year is not a MIPS eligible clinician, and therefore, is excluded 
from MIPS.
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 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 eligible clinician for a particular performance period; 
(2) the minimum number, as determined by the Secretary, of items and 
services furnished to Part B-enrolled individuals by the eligible 
clinician for a particular performance period; and (3) the minimum 
amount, as determined by the Secretary, of allowed charges billed by 
the eligible clinician for a particular performance period.
    In the CY 2017 Quality Payment Program final rule (81 FR 77069 
through 77070), we defined MIPS eligible clinicians or groups who do 
not exceed the low-volume threshold at Sec.  414.1305 as an individual 
MIPS eligible clinician or group who, during the low-volume threshold 
determination period, has Medicare Part B allowed charges less than or 
equal to $30,000 or provides care for 100 or fewer Part B-enrolled 
Medicare beneficiaries. We established at Sec.  414.1310(b) that for a 
year, eligible clinicians who do not exceed the low-volume threshold 
(as defined at Sec.  414.1305) are excluded from MIPS for the 
performance period for a given calendar year.
    In the CY 2017 Quality Payment Program final rule (81 FR 77069 
through 77070), we defined 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 spans from the last 4 months of a 
calendar year 2 years prior to the performance period followed by the 
first 8 months of the next calendar year and includes a 60-day claims 
run out, which allows 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 spans 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 
includes a 60-day claims run out, which allows us to inform additional 
eligible clinicians and groups of their low-volume status during the 
performance period.
    We recognize that individual MIPS eligible clinicians and groups 
that are small practices or practicing in designated rural areas face 
unique dynamics and challenges such as fiscal limitations and workforce 
shortages, but serve as a critical access point for care and provide a 
safety net for vulnerable populations. Claims data shows that 
approximately 15 percent of individual MIPS eligible clinicians (TIN/
NPIs) are considered to be practicing in rural areas after applying all 
exclusions. Also, we have heard from stakeholders that MIPS eligible 
clinicians practicing in small practices and designated rural areas 
tend to have a patient population with a higher proportion of older 
adults, as well as higher rates of poor health outcomes, co-
morbidities, chronic conditions, and other social risk factors, which 
can result in the costs of providing care and services being 
significantly higher compared to non-rural areas. We also have heard 
from many solo practitioners and small practices that still face 
challenges and additional resource burden in participating in the MIPS.
    In the CY 2017 Quality Payment Program final rule, we did not 
establish an adjustment for social risk factors in assessing and 
scoring performance. In response to the CY 2017 Quality Payment Program 
final rule, we received public comments indicating that individual MIPS 
eligible clinicians and groups practicing in designated rural areas 
would be negatively impacted and at a disadvantage if assessment and 
scoring methodology did not adjust for social risk factors. 
Additionally, commenters expressed concern that such individual MIPS 
eligible clinicians and groups may be disproportionately more 
susceptible to lower performance scores across all performance 
categories and negative MIPS payments adjustments, and as a result, 
such outcomes may further strain already limited fiscal resources and 
workforce shortages, and negatively impact access to care (reduction 
and/or elimination of available services).
    After the consideration of stakeholder feedback, we proposed to 
modify the low-volume threshold policy established in the CY 2017 
Quality Payment Program final rule (82 FR 30024). We stated that we 
believe that increasing the dollar amount and beneficiary count of the 
low-volume threshold would further reduce the number of eligible 
clinicians that are required to participate in the MIPS, which would 
reduce the burden on individual MIPS eligible clinicians and groups 
practicing in small practices and designated rural areas. Based on our 
analysis of claims data, we found that increasing the low-volume 
threshold to exclude individual eligible clinicians or groups that have 
Medicare Part B allowed charges less than or equal to $90,000 or that 
provide care for 200 or fewer Part B-enrolled Medicare beneficiaries 
will exclude approximately 134,000 additional clinicians from MIPS from 
the approximately 700,000 clinicians that would have been eligible 
based on the low-volume threshold that was finalized in the CY 2017 
Quality Payment Program final rule. Almost half of the additionally 
excluded clinicians are in small practices, and approximately 17 
percent are clinicians from practices in designated rural areas. 
Applying this

[[Page 53588]]

criterion decreases the percentage of the MIPS eligible clinicians that 
come from small practices. For example, prior to any exclusions, 
clinicians in small practices represent 35 percent of all clinicians 
billing Part B services. After applying the eligibility criteria for 
the CY 2017 Quality Payment Program final rule, MIPS eligible 
clinicians in small practices represent approximately 27 percent of the 
clinicians eligible for MIPS; however, with the increased low-volume 
threshold, approximately 22 percent of the clinicians eligible for MIPS 
are from small practices. In our analysis, the proposed changes to the 
low-volume threshold showed little impact on MIPS eligible clinicians 
from practices in designated rural areas. MIPS eligible clinicians from 
practices in designated rural areas account for15 to 16 percent of the 
total MIPS eligible clinician population. We note that, due to data 
limitations, we assessed rural status based on the status of individual 
TIN/NPI and did not model any group definition for practices in 
designated rural areas.
    We believe that increasing the number of such individual eligible 
clinicians and groups excluded from MIPS participation would reduce 
burden and mitigate, to the extent feasible, the issue surrounding 
confounding variables impacting performance under the MIPS. Therefore, 
beginning with the 2018 MIPS performance period, we proposed to 
increase the low-volume threshold. Specifically, at Sec.  414.1305, we 
proposed to define an individual MIPS eligible clinician or group who 
does 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 allowed charges less than or equal to 
$90,000 or provides care for 200 or fewer Part B-enrolled Medicare 
beneficiaries. This would mean that approximately 37 percent of 
individual eligible clinicians and groups would be eligible for MIPS 
based on the low-volume threshold exclusion (and the other exclusions). 
However, approximately 65 percent of Medicare payments would still be 
captured under MIPS as compared to 72.2 percent of Medicare payments 
under the CY 2017 Quality Payment Program final rule.
    We recognize that increasing the dollar amount and beneficiary 
count of the low-volume threshold would increase the number of 
individual eligible clinicians and groups excluded from MIPS. We 
assessed various levels of increases and found that $90,000 as the 
dollar amount and 200 as the beneficiary count balances the need to 
account for individual eligible clinicians and groups who face 
additional participation burden while not excluding a significant 
portion of the clinician population.
    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 
eligible clinicians who practice in APMs under the APM scoring standard 
at the APM Entity level, in which APM Entities do not exceed the low-
volume threshold. In such cases, the eligible clinicians participating 
in the MIPS APM Entity would be excluded from the MIPS requirements for 
the applicable performance period and not subject to a MIPS payment 
adjustment for the applicable year. Such an exclusion would not affect 
an APM Entity's QP determination if the APM Entity is an Advanced APM.
    In the CY 2017 Quality Payment Program final rule, we established 
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 (81 FR 77069 through 77070). We 
defined 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. Based on our analysis of data from the initial segment of the 
low-volume threshold determination period for performance periods 
occurring in 2017 (that is, data spanning from September 1, 2015 to 
August 31, 2016), we found that it may not be necessary to include a 
60-day claims run out since we could achieve a similar outcome for such 
eligibility determinations by utilizing a 30-day claims run out.
    In our comparison of data analysis results utilizing a 60-day 
claims run out versus a 30-day claims run out, there was a 1 percent 
decrease in data completeness. The small decrease in data completeness 
would not substantially impact individual MIPS eligible clinicians or 
groups regarding low-volume threshold determinations. We believe that a 
30-day claims run out would allow us to complete the analysis and 
provide such determinations in a more timely manner. For performance 
periods occurring in 2018 and future years, we proposed a modification 
to the low-volume threshold determination period, in which 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 30-day claims run out; and 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 30-day claims run out 
(82 FR 30025). We stated that the proposal would only change the 
duration of the claims run out, not the 12-month timeframes used for 
the first and second segments of data analysis.
    For purposes of the 2020 MIPS payment year, we would initially 
identify individual eligible clinicians and groups that do not exceed 
the low-volume threshold based on 12 months of data starting from 
September 1, 2016 to August 31, 2017. To account for the identification 
of additional individual eligible clinicians and groups that do not 
exceed the low-volume threshold during performance periods occurring in 
2018, we would conduct another eligibility determination analysis based 
on 12 months of data starting from September 1, 2017 to August 31, 
2018. We would 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 would continue to be excluded from MIPS for the duration of 
the performance period regardless of the results of the second 
eligibility determination analysis. We established our policy to 
include two eligibility determination analyses in order to prevent any 
potential confusion for an individual eligible clinician or group to 
know whether or not participate in MIPS; also, such policy makes it 
clear from the onset as to which individual eligible clinicians and 
groups would be required to participate in MIPS. We would 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 note that low-volume threshold determinations are made at 
the individual and group level, and not at the virtual group level.
    As noted above, section 1848(q)(1)(C)(iv) of the Act requires the

[[Page 53589]]

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 eligible clinician for a particular 
performance period; (2) the minimum number, as determined by the 
Secretary, of items and services furnished to Part B-enrolled 
individuals by the eligible clinician for a particular performance 
period; and (3) the minimum amount, as determined by the Secretary, of 
allowed charges billed by the eligible clinician for a particular 
performance period. We have established a low-volume threshold that 
accounts for the minimum number of Part-B enrolled individuals who are 
treated by an eligible clinician and that accounts for the minimum 
amount of allowed charges billed by an eligible clinician. We did not 
make proposals specific to a minimum number of items and service 
furnished to Part-B enrolled individuals by an eligible clinician.
    In order to expand the ways in which claims data could be analyzed 
for purposes of determining a more comprehensive assessment of the low-
volume threshold, we have assessed the option of establishing a low-
volume threshold for items and services furnished to Part-B enrolled 
individuals by an eligible clinician. We have considered defining items 
and services by using the number of patient encounters or procedures 
associated with a clinician. Defining items and services by patient 
encounters would assess each patient per visit or encounter with the 
eligible clinician. We believe that defining items and services by 
using the number of patient encounters or procedures is a simple and 
straightforward approach for stakeholders to understand. However, we 
are concerned that using this unit of analysis could incentivize 
clinicians to focus on volume of services rather than the value of 
services provided to patients. Defining items and services by procedure 
would tie a specific clinical procedure furnished to a patient to a 
clinician. We solicited public comment on the methods of defining items 
and services furnished by clinicians described in this paragraph above 
and alternate methods of defining items and services (82 FR 30025 
through 30026).
    For the individual eligible clinicians and groups that would be 
excluded from MIPS participation as a result of an increased low-volume 
threshold, we believe that in future years it would be beneficial to 
provide, to the extent feasible, such individual eligible clinicians 
and groups with the option to opt-in to MIPS participation if they 
might otherwise be excluded under the low-volume threshold, such as 
where they only meet one of the threshold determinations (including a 
third determination based on Part B items and services, if 
established). For example, if a clinician meets the low-volume 
threshold of $90,000 in allowed charges, but does not meet the 
threshold of 200 patients or, if established, the threshold pertaining 
to Part B items and services, we believe the clinician should, to the 
extent feasible, have the opportunity to choose whether or not to 
participate in the MIPS and be subject to MIPS payment adjustments. We 
recognize that this choice would present additional complexity to 
clinicians in understanding all of their available options and may 
impose additional burden on clinicians by requiring them to notify us 
of their decision. Because of these concerns and our desire to 
establish options in a way that is a low-burden and user-focused 
experience for all MIPS eligible clinicians, we would not be able to 
offer this additional flexibility until performance periods occurring 
in 2019. Therefore, as a means of expanding options for clinicians and 
offering them the ability to participate in MIPS if they otherwise 
would not be included, for the purposes of the 2021 MIPS payment year, 
we proposed to provide clinicians the ability to opt-in to the MIPS if 
they meet or exceed one, but not all, of the low-volume threshold 
determinations, including as defined by dollar amount, beneficiary 
count or, if established, items and services (82 FR 30026).
    We note that there may be additional considerations we should 
address for scenarios in which an individual eligible clinician or a 
group does not exceed the low-volume threshold and opts-in to 
participate in MIPS. We therefore sought comment on any additional 
considerations we should address when establishing this opt-in policy. 
Additionally, we note that there is the potential with this opt-in 
policy for there to be an impact on our ability to create quality 
benchmarks that meet our sample size requirements. For example, if 
particularly small practices or solo practitioners with low Part B 
beneficiary volumes opt-in, such clinicians may lack sufficient sample 
size to be scored on many quality measures, especially measures that do 
not apply to all of a MIPS eligible clinician's patients. We therefore 
sought comment on how to address any potential impact on our ability to 
create quality benchmarks that meet our sample size requirements (82 FR 
30026).
    The following is a summary of the public comments received on the 
``Low-Volume Threshold'' proposals and our responses:
    Comment: Many commenters supported raising the low-volume threshold 
to exclude an individual MIPS eligible clinician or group who, during 
the low-volume threshold determination period, has Medicare Part B 
allowed charges less than or equal to $90,000 or provides care for 200 
or fewer Part B-enrolled Medicare beneficiaries. Several commenters 
further suggested that we retroactively apply the threshold to the 2017 
MIPS performance period because changing the low-volume threshold for 
the 2018 MIPS performance period would create confusion, complicate 
operational and strategic planning for eligible clinicians, and create 
inefficiencies for clinicians. One commenter noted that we has not yet 
issued the required second round of reports notifying MIPS eligible 
clinicians whether they are below the low-volume threshold, so it would 
be technically feasible to implement the lower threshold before the end 
of the CY 2017 reporting period. A few commenters supported the 
proposal but recommended that we maintain the current, lower low-volume 
threshold for at least 2, 3, or more years to allow for planning and 
investment by clinicians in the program.
    Response: We appreciate the support from commenters who supported 
raising the low-volume threshold. We are finalizing our proposal to 
define at Sec.  414.1305 an individual eligible clinician or group that 
does not exceed the low-volume threshold as an individual eligible 
clinician or group that, during the low-volume threshold determination 
period, has Medicare Part B allowed charges less than or equal to 
$90,000 or provides care for 200 or fewer Part B-enrolled Medicare 
beneficiaries. We do not believe that we have the flexibility to 
retroactively apply the revised low-volume threshold to the 2017 MIPS 
performance period threshold. We are aware that by finalizing this 
policy, some MIPS eligible clinicians who were eligible to participate 
in MIPS for Year 1 will be excluded for Year 2. However, we would like 
to note that those MIPS eligible clinicians may still participate in 
Year 1. Finally, we agree with the commenter that there are benefits of 
maintaining the same low-volume threshold for several years and will 
take this into consideration in future years.
    Comment: Several commenters did not support the proposed low-volume 
threshold because the commenters believed the low-volume threshold

[[Page 53590]]

should be raised further to exclude more clinicians. Several of those 
commenters specifically recommended that we set the threshold no lower 
than $100,000 in Medicare Part B charges and to only apply to practices 
with 10 or fewer eligible clinicians.
    Response: We disagree with the commenters regarding raising the 
low-volume threshold further. Based on our data analysis, applying the 
proposed criterion decreases the percentage of MIPS eligible clinicians 
that come from small practices. We note that from our updated data 
models we found that the revised low-volume threshold will exclude 
approximately 123,000 additional clinicians from MIPS from the 
approximately 744,000 clinicians that would have been eligible based on 
the low-volume threshold that was finalized in the CY 2017 Quality 
Payment Program final rule. We believe that if we were to raise the 
low-volume threshold further, we may prevent medium size practices that 
wish to participate from the opportunity to receive an upward 
adjustment and would have fewer clinicians engaged in value-based care. 
We believe the finalized low-volume threshold strikes the appropriate 
balance with the need to account for individual MIPS eligible 
clinicians and groups who face additional participation burden while 
not excluding a significant portion of the clinician population. We are 
finalizing the low-volume threshold to exclude an individual eligible 
clinician or group that, during the low-volume threshold determination 
period, has Medicare Part B allowed charges less than or equal to 
$90,000 or provides care for 200 or fewer Part B-enrolled Medicare 
beneficiaries.
    Comment: Many commenters did not support raising the low-volume 
threshold for the 2018 MIPS performance period because they believed it 
would be unfair to clinicians who were already participating or planned 
to participate in MIPS in future years. The commenters noted that 
clinicians may have already invested in MIPS participation. Many 
commenters did not support the proposed low-volume threshold because 
they believed that raising the low-volume threshold would reduce 
payment and incentives for excluded clinicians to participate in value-
based care, which would create additional quality and reimbursement 
disparities for the beneficiaries seen by the excluded clinicians, 
creating a 2-tiered system of clinicians and related beneficiaries that 
are participating in value-based care. The commenters noted that 
raising the low-volume threshold would signal to the industry that we 
are not focused on transitioning to value-based payment and care. A few 
commenters expressed concern that raising the low-volume threshold 
would create further disparities in quality between urban and rural 
clinicians based on the reduced incentives for rural clinicians to 
participate in value-based purchasing programs. One of these commenters 
strongly recommended that we study the impact on the rural health 
industry prior to implementing the increased low-volume threshold. Many 
commenters noted that excluding more clinicians would risk dismantling 
the EHR infrastructure that has developed over recent years as 
additional practices opt-out of participation in programs designed to 
increase adoption and use of EHRs, wasting the billions of dollars we 
have invested to date in EHRs. The commenters believed that reduction 
in use of EHRs will affect participating clinicians as well by 
hampering connectivity and information sharing between excluded 
clinicians and participating clinicians. Some commenters also stated 
that decreased investment in EHRs by excluded clinicians will drive 
greater disparities in care quality between clinicians who are engaged 
in value-based purchasing and those who are not. One commenter strongly 
recommended that we delay implementation of the proposed low-volume 
threshold. Another commenter recommended that, rather than exclude 
clinicians from MIPS, we should allow clinicians to continue the pick-
your-pace approach and continue participating in MIPS.
    Response: We acknowledge there will be MIPS eligible clinicians who 
were eligible for Year 1 of MIPS that are no longer eligible for Year 2 
of MIPS. However, from our analyses, the MIPS eligible clinicians 
affected are mainly smaller practices and practices in rural areas, 
many of which have raised concerns regarding their ability to 
participate in MIPS. We want to encourage all clinicians to participate 
in value-based care within the MIPS; however, we have continued to hear 
from practices that challenges to participation in the Quality Payment 
Program still exist. Therefore, we believe it is appropriate to raise 
the low-volume threshold to not require these practices to participate 
in the program. However, we will review the impacts of this policy to 
determine if it should remain. We do not believe that raising the low-
volume threshold will cause quality disparities between urban and rural 
practices. With the increased low-volume threshold, additional 
practices will not be required to participate in the Quality Payment 
Program; however, we still encourage all clinicians to provide high-
value care to their patients. The goal of raising the low-volume 
threshold is to reduce burden on small practices, and we do not believe 
it will create a 2-tiered system. We appreciate the suggestion to study 
the impact on the rural health industry before finalizing this policy. 
We do not believe a study is necessary prior to finalizing this policy; 
rather, we believe that there is sufficient evidence from stakeholder 
feedback to reflect the value of increasing the low-volume threshold at 
this time. We do not agree that this policy would risk dismantling the 
EHR infrastructure. We believe that the low-volume threshold in Year 2 
provides MIPS eligible clinicians and groups, particularly those in 
smaller practices and rural areas, that do not exceed the low-volume 
threshold with additional time to further invest in their EHR 
infrastructure to gain experience in implementing and utilizing an EHR 
infrastructure to meet their needs and prepare for their potential 
participation in MIPS in future years while not being subject to the 
possibility of a negative payment adjustment. We believe that 
clinicians and patients benefit from the utilization and capabilities 
of an EHR infrastructure and would continue to utilize this technology. 
In addition, we do not believe we should delay implementation of this 
policy as it reduces the burden on individual MIPS eligible clinicians 
and those in small practices and in some rural areas. The intention of 
the Year 1 pick-your-pace policies were to set the foundation for MIPS 
to support long-term, high quality patient care through feedback by 
lowering the barriers to participation. Year 2 continues this 
transition as we are providing a gradual ramp-up of the program and of 
the performance thresholds. For the low-volume threshold, we are 
finalizing our proposal to increase the threshold, which excludes more 
eligible clinicians from MIPS. Specifically, we are finalizing our 
proposal to exclude an individual eligible clinician or group that, 
during the low-volume threshold determination period, has Medicare Part 
B allowed charges less than or equal to $90,000 or provides care for 
200 or fewer Part B-enrolled Medicare beneficiaries.
    Comment: Many commenters did not support the proposed low-volume 
threshold because it is based on the amount of Medicare billings from 
clinicians or number of beneficiaries. Instead, the commenters offered

[[Page 53591]]

recommendations for alternative ways of applying the low-volume 
threshold. Many commenters recommended that we exclude all practices 
with 15 or fewer clinicians. Several commenters recommended redefining 
the low-volume threshold so that it would mirror the policy for non-
patient facing eligible clinicians by excluding a group from MIPS if 75 
percent or more of its eligible clinicians individually fall below the 
low-volume threshold or if the group's average Medicare allowed charges 
or Medicare patient population falls below the threshold. The 
commenters noted that this would align status determinations across the 
Quality Payment Program and reduce complexity and burden. One commenter 
recommended excluding: Practices with less than $100,000 per clinician 
in Medicare charges not including Part B drug costs; practices with 10 
or fewer clinicians; and rural clinicians practicing in an area with 
fewer than 100 clinicians per 100,000 population. The commenter further 
encouraged us to consider excluding specialists who practice in ZIP 
codes or other geographic areas with low per capita numbers of 
clinicians in their specialty per population. One commenter recommended 
that we establish 2 different low-volume thresholds for primary care 
and specialty care clinicians. Another commenter recommended using a 
percentage of Medicare charges to total charges and a percentage of 
Medicare patients to total patients as opposed to the use of claims and 
patients. One commenter noted that the low-volume threshold's inclusion 
of beneficiaries creates an incentive for clinicians to turn away 
Medicare beneficiaries in order to fall below the low-volume threshold. 
Another commenter recommended that we exclude all clinicians who have 
elected to have non-participation status for Medicare. As an 
alternative to raising the low-volume threshold, one commenter 
recommended that we reduce the reporting requirement for small 
practices or for those practices between the previous threshold of 
$30,000 and 100 beneficiaries to $90,000 and 200 beneficiaries. Several 
commenters specifically did not support that a group could meet the 
low-volume threshold based on services provided by a small percentage 
of the clinicians in the group. A few commenters recommended that we 
exclude individuals who do not meet the low-volume threshold, even if 
the group practice otherwise met the low-volume threshold.
    Response: We note that some of the suggestions provided are not 
compliant with the statute, specifically, the suggestions on basing the 
low-volume threshold exclusion on practice size, practice location and 
specialty characteristics. We note that 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 
eligible clinician for a particular performance period; (2) the minimum 
number, as determined by the Secretary, of items and services furnished 
to Part B-enrolled individuals by the eligible clinician for a 
particular performance period; and (3) the minimum amount, as 
determined by the Secretary, of allowed charges billed by the eligible 
clinician for a particular performance period. We do not believe the 
statute provides discretion in establishing exclusions other than the 
three exclusions specified above. Additionally, for the commenters 
suggestion to use a percentage of Medicare charges to total charges and 
a percentage of Medicare patients to total patients as opposed to the 
use of a minimum number of claims and patients, we will take this 
suggestion under consideration for future rulemaking. In regards to the 
commenters suggestion to exclude all clinicians from MIPS that have 
non-participation status within Medicare, we note that these clinicians 
may still fall within the definition of a MIPS eligible clinician at 
Sec.  414.1305. However, as provided in Sec.  414.1310(d), in no case 
will a MIPS payment adjustment apply to the items and services 
furnished during a year by clinicians who are not MIPS eligible 
clinicians.
    We note that the low-volume threshold is different from the other 
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. In the CY 2017 Quality Payment 
Program final rule (82 FR 77071) we considered aligning how MIPS 
exclusions would be applied at the group level. We recognized that 
alignment would provide a uniform application across exclusions and 
offer simplicity, but we also believed that 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 finalized that we would 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. We appreciate the other concerns and 
recommendations provided by the commenters. We received a range of 
suggestions and considered the various options. We are finalizing our 
proposal to exclude an individual MIPS eligible clinician or group 
that, during the low-volume threshold determination period, has 
Medicare Part B allowed charges less than or equal to $90,000 or 
provides care for 200 or fewer Part B-enrolled Medicare beneficiaries. 
In this final rule with comment period, we are requesting additional 
comments regarding the application of low-volume threshold at the group 
level.
    Comment: Many commenters supported the proposed policy to provide 
clinicians the ability to opt-in to the MIPS if they meet or exceed 
one, but not all, of the low-volume threshold determinations, including 
as defined by dollar amount, beneficiary count, or, if established, 
items and services beginning with the 2019 MIPS performance period. 
Other commenters supported applying the opt-in based on the Medicare 
Part B charges criterion, but not the Medicare beneficiary criterion. 
Several commenters supported the proposal to allow opt-in but requested 
that the policy be retroactively applied to the 2017 MIPS performance 
period. A few commenters supported the proposed opt-in option but 
recommended that we establish separate performance benchmarks for 
excluded individuals or groups that opt-in. Other commenters 
recommended that we shield opt-in clinicians so that they can avoid a 
negative payment adjustment or other disadvantages of participation.
    Response: We appreciate the support of the proposed policy to 
provide clinicians the ability to opt-in to the MIPS if they meet or 
exceed one, but not all, of the low-volume threshold

[[Page 53592]]

determinations, including as defined by dollar amount, beneficiary 
count, or, if established, items and services beginning with the 2019 
MIPS performance period. However, we are not finalizing this proposal 
for the 2019 MIPS performance period. We are concerned that we will not 
be able to operationalize this policy in a low-burden manner to MIPS 
eligible clinicians as currently proposed. Specifically, our goal is to 
implement a process whereby a clinician can be made aware of their low-
volume threshold status and make an informed decision on whether they 
will participate in MIPS or not. We believe it is critical to implement 
a process that provides the least burden to clinicians in communicating 
this decision to us. Therefore, in this final rule with comment period, 
we are seeking additional comments on the best approach of implementing 
a low-volume threshold opt-in policy. As we plan to revisit this policy 
in the 2018 notice-and-comment rulemaking cycle. This additional time 
and additional public comments will give us the opportunity to explore 
how best to implement this policy and to perform additional analyses. 
We do not agree that we should allow any MIPS eligible clinicians that 
meet the low-volume threshold exclusion from any criterion to opt-in to 
MIPS, as it may impact our ability to create quality performance 
benchmarks that meet our sample size requirements. For example, if 
particularly small practices or solo practitioners with low Part B 
beneficiary volumes opt-in, such clinician's may lack sufficient sample 
size to be scored on many quality measures, especially measures that do 
not apply to all of a MIPS eligible clinician's patients. In addition, 
we do not believe MIPS eligible clinicians who opt-in should have 
different performance benchmarks nor avoid a negative payment 
adjustment. If the MIPS eligible clinician decides to opt-in, then they 
are committing to participating in the entire program, which would 
include being assessed on the same criteria as other MIPS eligible 
clinicians.
    Comment: A few commenters opposed the proposed policy to provide 
clinicians the ability to opt-in to the MIPS if they meet or exceed 
one, but not all, of the low-volume threshold determinations, including 
as defined by dollar amount, beneficiary count, or, if established, 
items and services beginning with the 2019 MIPS performance period. One 
commenter believed that an opt-in policy would complicate the program's 
ability to accurately evaluate clinician performance, which may result 
in unequal outcomes based on clinician participation at the individual- 
or group-level and specialty types. The commenter recommended that we 
fully evaluate the effect of the opt-in policy prior to implementing 
any changes.
    Response: We agree with the commenters' concerns and acknowledge 
that allowing an opt-in option may present additional complexity and 
could inadvertantly create a model where only high-performers opt-in. 
Therefore, we are not finalizing this proposal for the 2019 MIPS 
performance period. Rather, we are seeking further comment on the best 
approach to implementing the low-volume opt-in policy. This additional 
time will give us the opportunity to perform additional analyses. We 
intend to revisit this policy in the 2018 notice-and-comment rulemaking 
cycle.
    Comment: Several commenters supported the current low-volume 
threshold assessment period and proposal to use a 30-day claims run 
out. One commenter agreed with retaining the low-volume threshold 
status if triggered during the first 12-month determination period 
regardless of the status resulting from the second 12-month 
determination period. Another commenter did not support the use of a 
determination period for low-volume threshold that is outside of the 
performance period and believed that only data overlapping the 
performance period should be used to determine low-volume threshold 
status.
    Response: We appreciate the commenters' support of the low-volume 
threshold determination period and the proposed use of a 30-day claims 
run out. We believe that it is beneficial for MIPS eligible clinicians 
to know whether they are excluded under the low-volume threshold prior 
to the start of the performance period. In order to identify these MIPS 
eligible clinicians prior to the start of the performance period, we 
must use historical data that is outside of the performance period. We 
refer commenters to the CY 2017 Quality Payment Program final rule (82 
FR 77069 through 77070) for a full discussion of this policy.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to define at Sec.  414.1305 an individual 
eligible clinician or group that does not exceed the low-volume 
threshold as an individual eligible clinician or group that, during the 
low-volume threshold determination period, has Medicare Part B allowed 
charges less than or equal to $90,000 or provides care for 200 or fewer 
Part B-enrolled Medicare beneficiaries. In addition, for performance 
periods occurring in 2018 and future years, we are finalizing a 
modification to the low-volume threshold determination period, in which 
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 30-day claims run out; and 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 30-day claims run out. 
In addition, in this final rule with comment period, we are seeking 
further comment on the best approach to implementing a low-volume 
threshold opt-in policy. We welcome suggestions on ways to implement 
the low-volume threshold opt-in that does not add additional burden to 
clinicians. We also are interested in receiving feedback on ways to 
mitigate our concern that only high-performers will choose to opt-in. 
We also are soliciting comment on whether our current application of 
the low-volume threshold to groups is still appropriate. We refer 
readers to the CY 2017 Quality Payment Program final rule (81 FR 77062 
through 77070) for a discussion on how the low-volume threshold is 
currently applied to groups.
3. Group Reporting
a. Background
    As discussed in the CY 2017 Quality Payment Program final rule, we 
established the following requirements for groups (81 FR 77072):
     Individual eligible clinicians and individual MIPS 
eligible clinicians will have their performance assessed as a group as 
part of a single TIN associated with two or more eligible clinicians 
(including at least one MIPS eligible clinician), as identified by an 
NPI, who have reassigned their Medicare billing rights to the TIN (at 
Sec.  414.1310(e)(1)).
     A group must meet the definition of a group at all times 
during the performance period for the MIPS payment year in order to 
have its performance assessed as a group (at Sec.  414.1310(e)(2)).
     Individual eligible clinicians and individual MIPS 
eligible clinicians within a group must aggregate their performance 
data across the TIN to have their performance assessed as a group (at 
Sec.  414.1310(e)(3)).

[[Page 53593]]

     A group that elects to have its performance assessed as a 
group will be assessed as a group across all four MIPS performance 
categories (at Sec.  414.1310(e)(4)).
    We stated in the CY 2017 Quality Payment Program final rule that 
groups attest to their group size for purpose of using the CMS Web 
Interface or identifying as a small practice (81 FR 77057). In section 
II.C.1.c. of this final rule with comment period, we are finalizing our 
proposal to modify the way in which we determine small practice size by 
establishing a process under which CMS would utilize claims data to 
make small practice size determinations. In addition, in section 
II.C.4.e. of this final rule comment period, we are finalizing our 
proposal to establish a policy under which CMS would utilize claims 
data to determine group size for groups of 10 or fewer eligible 
clinicians seeking to form or join a virtual group.
    As noted in the CY 2017 Quality Payment Program final rule, group 
size would be determined before exclusions are applied (81 FR 77057). 
We note that group size determinations are based on the number of NPIs 
associated with a TIN, which would include individual eligible 
clinicians (NPIs) who may be excluded from MIPS participation and do 
not meet the definition of a MIPS eligible clinician.
b. Registration
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77072 through 77073), we established the following policies:
     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 mechanisms, groups 
must work with appropriate third party intermediaries 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, 2018, for performance periods occurring in 2018). We note that 
groups participating in APMs that require APM Entities to report using 
the CMS Web Interface are not required to register for the CMS Web 
Interface or administer the CAHPS for MIPS survey separately from the 
APM.
    When groups submit data utilizing third party intermediaries, such 
as a qualified registry, QCDR, or EHR, we are able to obtain group 
information from the third party intermediary and discern whether the 
data submitted represents group submission or individual submission 
once the data are submitted.
    In the CY 2017 Quality Payment Program final rule (81 FR 77072 
through 77073), we discussed the implementation of a voluntary 
registration process if technically feasible. Since the publication of 
the CY 2017 Quality Payment Program final rule, we have determined that 
it is not technically feasible to develop and build a voluntary 
registration process. Until further notice, we are not implementing a 
voluntary registration process.
    Also, in the CY 2017 Quality Payment Program final rule (81 FR 
77075), we expressed our commitment to pursue the active engagement of 
stakeholders throughout the process of establishing and implementing 
virtual groups. Please refer to the CY 2018 Quality Payment Program 
proposed rule (82 FR 30027) for a full discussion of the public 
comments and additional stakeholder feedback we received in response to 
the CY 2017 Quality Payment Program final rule and additional 
stakeholder feedback gathered through hosting several virtual group 
listening sessions and convening user groups.
    As discussed in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30027), one of the overarching themes we have heard is that we 
make an option available to groups that would allow a portion of a 
group to report as a separate subgroup on measures and activities that 
are more applicable to the subgroup and be assessed and scored 
accordingly based on the performance of the subgroup. In future 
rulemaking, we intend to explore the feasibility of establishing group-
related policies that would permit participation in MIPS at a subgroup 
level and create such functionality through a new identifier. 
Therefore, we solicited public comment on the ways in which 
participation in MIPS at the subgroup level could be established. In 
addition, in this final rule with comment period, we are seeking 
comment on additional ways to define a group, not solely based on a 
TIN. For example, redefining a group to allow for practice sites to be 
reflected and/or for specialties within a TIN to create groups.
    We received several comments on subgroup level policies and will 
take them into consideration for future rulemaking.
4. Virtual Groups
a. Background
    There are generally three ways to participate in MIPS: (1) 
Individual-level reporting; (2) group-level reporting; and (3) virtual 
group-level reporting. In the CY 2018 Quality Payment Program proposed 
rule (82 FR 30027 through 30034), we proposed to establish requirements 
for MIPS participation at the virtual group level.
    Section 1848(q)(5)(I) of the Act provides for the use of voluntary 
virtual groups for certain assessment purposes, including the election 
of certain practices to be a virtual group and the requirements for the 
election process. Section 1848(q)(5)(I)(i) of the Act provides that 
MIPS eligible clinicians electing to be a virtual group must: (1) Have 
their performance assessed for the quality and cost performance 
categories in a manner that applies the combined performance of all the 
MIPS eligible clinicians in the virtual group to each MIPS eligible 
clinician in the virtual group for the applicable performance period; 
and (2) be scored for the quality and cost performance categories based 
on such assessment for the applicable performance period. Section 
1848(q)(5)(I)(ii) of the Act requires the Secretary to establish and 
implement, in accordance with section 1848(q)(5)(I)(iii) of the Act, a 
process that allows an individual MIPS eligible clinician or a group 
consisting of not more than 10 MIPS eligible clinicians to elect, for a 
performance period, to be a virtual group with at least one other such 
individual MIPS eligible clinician or group. Virtual groups may be 
based on appropriate classifications of providers, such as by 
geographic areas or by provider specialties defined by nationally 
recognized specialty boards of certification or equivalent 
certification boards.
    Section 1848(q)(5)(I)(iii) of the Act provides that the virtual 
group election process must include the following requirements: (1) An 
individual MIPS eligible clinician or group electing to be in a virtual 
group must make their election prior to the start of the applicable 
performance period and cannot change their election during the 
performance period; (2) an individual MIPS eligible clinician or group 
may elect to be in no more than one virtual group for a performance 
period, and, in the case of a group, the election applies to all MIPS 
eligible clinicians in the

[[Page 53594]]

group; (3) a virtual group is a combination of TINs; (4) requirements 
providing for formal written agreements among individual MIPS eligible 
clinicians and groups electing to be a virtual group; and (5) such 
other requirements as the Secretary determines appropriate.
b. Definition of a Virtual Group
(1) Generally
    As noted above, section 1848(q)(5)(I)(ii) of the Act requires the 
Secretary to establish and implement, in accordance with section 
1848(q)(5)(I)(iii) of the Act, a process that allows an individual MIPS 
eligible clinician or group consisting of not more than 10 MIPS 
eligible clinicians to elect, for a performance period, to be a virtual 
group with at least one other such individual MIPS eligible clinician 
or group. Given that section 1848(q)(5)(I)(iii)(III) of the Act 
provides that a virtual group is a combination of TINs, we interpreted 
the references to an ``individual'' MIPS eligible clinician in section 
1848(q)(5)(I)(ii) of the Act to mean a solo practitioner, which, for 
purposes of section 1848(q)(5)(I) of the Act, we proposed to define as 
a MIPS eligible clinician (as defined at Sec.  414.1305) who bills 
under a TIN with no other NPIs billing under such TIN (82 FR 30027).
    Also, we recognized that a group (TIN) may include not only NPIs 
who meet the definition of a MIPS eligible clinician, but also NPIs who 
do not meet the definition of a MIPS eligible clinician at Sec.  
414.1305 or who are excluded from the definition of a MIPS eligible 
clinician under Sec.  414.1310(b) or (c). Thus, we interpreted the 
references to a group ``consisting of not more than 10'' MIPS eligible 
clinicians in section 1848(q)(5)(I)(ii) of the Act to mean a group with 
10 or fewer eligible clinicians (as such terms are defined at Sec.  
414.1305) (82 FR 30027). Under Sec.  414.1310(d), the MIPS payment 
adjustment would apply only to NPIs in the virtual group who meet the 
definition of a MIPS eligible clinician at Sec.  414.1305 and who are 
not excluded from the definition of a MIPS eligible clinician under 
Sec.  414.1310(b) or (c). We noted that groups must include at least 
one MIPS eligible clinician in order to meet the definition of a group 
at Sec.  414.1305 and thus be eligible to form or join a virtual group.
    We proposed to define a virtual group at Sec.  414.1305 as a 
combination of two or more TINs composed of a solo practitioner (that 
is, a MIPS eligible clinician (as defined at Sec.  414.1305) who bills 
under a TIN with no other NPIs billing under such TIN) or a group with 
10 or fewer eligible clinicians (as such terms are defined at Sec.  
414.1305) under the TIN that elects to form a virtual group with at 
least one other such solo practitioner or group for a performance 
period for a year (82 FR 30027 through 30028).
    With regard to the low-volume threshold, we recognized that such 
determinations are made at the individual and group level, but not at 
the virtual group level (82 FR 30031). For example, if an individual 
MIPS eligible clinician is part of a practice that is participating in 
MIPS (that is, reporting) at the individual level, then the low-volume 
threshold determination is made at the individual level. Whereas, if an 
individual MIPS eligible clinician is part of a practice that is 
participating in MIPS (that is, reporting) at the group level, then the 
low-volume threshold determination is made at the group level and would 
be applicable to such MIPS eligible clinician regardless of the low-
volume threshold determination made at the individual level. Similarly, 
if a solo practitioner or a group with 10 or fewer eligible clinicians 
seeks to participate in MIPS (that is, report) at the virtual group 
level, then the low-volume threshold determination made at the 
individual or group level, respectively, would be applicable to such 
solo practitioner or group. Thus, solo practitioners or groups with 10 
or fewer eligible clinicians that are determined not to exceed the low-
volume threshold at the individual or group level, respectively, would 
not be eligible to participate in MIPS as an individual, group, or 
virtual group, as applicable.
    Given that a virtual group must be a combination of TINs, we 
recognized that the composition of a virtual group could include, for 
example, one solo practitioner (NPI) who is practicing under multiple 
TINs (TIN A and TIN B), in which the solo practitioner would be able to 
form a virtual group with his or her own self based on each TIN 
assigned to the solo practitioner (TIN A/NPI and TIN B/NPI) (82 FR 
30032). As discussed in section II.C.4.b.(3) of this final rule with 
comment period, we did not propose to establish a limit on the number 
of TINs that may form a virtual group at this time.
    Lastly, we noted that qualification as a virtual group for purposes 
of MIPS does not change the application of the physician self-referral 
law to a financial relationship between a physician and an entity 
furnishing designated health services, nor does it change the need for 
such a financial relationship to comply with the physician self-
referral law (82 FR 30028).
    We refer readers to section II.C.4.b.(3) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(2) Application to Groups Containing Participants in a MIPS APM or an 
Advanced APM
    Additionally, we recognized that there are circumstances in which a 
TIN may have one portion of its NPIs participating under the generally 
applicable MIPS scoring criteria while the remaining portion of NPIs 
under the TIN is participating in a MIPS APM or an Advanced APM under 
the MIPS APM scoring standard (82 FR 30028). To clarify, for all 
groups, including those containing participants in a MIPS APM or an 
Advanced APM, the group's performance assessment will be based on the 
performance of the entire TIN. Generally, for groups other than those 
containing participants in a MIPS APM or an Advanced APM, each MIPS 
eligible clinician under the TIN (TIN/NPI) receives a MIPS adjustment 
based on the entire group's performance assessment (entire TIN). For 
groups containing participants in a MIPS APM or an Advanced APM, only 
the portion of the TIN that is being scored for MIPS according to the 
generally applicable scoring criteria (TIN/NPI) receives a MIPS 
adjustment based on the entire group's performance assessment (entire 
TIN). The remaining portion of the TIN that is being scored according 
to the APM scoring standard (TIN/NPI) receives a MIPS adjustment based 
on that standard. We noted that such participants may be excluded from 
MIPS if they achieve QP or Partial QP status. For more information, we 
refer readers to the CY 2017 Quality Payment Program final rule (81 FR 
77058, 77330 through 77331).
    We proposed to apply a similar policy to groups, including those 
containing participants in a MIPS APM or an Advanced APM, that are 
participating in MIPS as part of a virtual group (82 FR 30028). 
Specifically, for groups other than those containing participants in a 
MIPS APM or an Advanced APM, each MIPS eligible clinician under the TIN 
(TIN/NPI) would receive a MIPS adjustment based on the virtual group's 
combined performance assessment (combination of TINs). For groups 
containing participants in a MIPS APM or an Advanced APM, only the 
portion of the TIN that is being scored for MIPS according to the 
generally applicable scoring criteria (TIN/NPI) would receive a MIPS 
adjustment based on the virtual

[[Page 53595]]

group's combined performance assessment (combination of TINs). As 
discussed in section II.C.6.g. of this final rule with comment period, 
we proposed to use waiver authority to ensure that the remaining 
portion of the TIN that is being scored according to the APM scoring 
standard (TIN/NPI) would receive a MIPS adjustment based on that 
standard. We noted that such participants may be excluded from MIPS if 
they achieve QP or Partial QP status.
    We refer readers to section II.C.4.b.(3) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(3) Appropriate Classifications
    As noted above, the statute provides the Secretary with discretion 
to establish appropriate classifications regarding the composition of 
virtual groups, such as by geographic area or by specialty. We 
recognized that virtual groups would each have unique characteristics 
and varying patient populations. However, we believe it is important 
for virtual groups to have the flexibility to determine their own 
composition at this time, and, as a result, we did not propose to 
establish any such classifications regarding virtual group composition 
(82 FR 30028).
    We further noted that the statute does not limit the number of TINs 
that may form a virtual group, and we did not propose to establish such 
a limit at this time (82 FR 30028). We did consider proposing to 
establish such a limit, such as 50 or 100 participants. In particular, 
we were concerned that virtual groups of too substantial a size (for 
example, 10 percent of all MIPS eligible clinicians in a given 
specialty or sub-specialty) may make it difficult to compare 
performance between and among clinicians. We believe that limiting the 
number of virtual group participants could eventually assist virtual 
groups as they aggregate their performance data across the virtual 
group. However, we believe that as we initially implement virtual 
groups, it is important for virtual groups to have the flexibility to 
determine their own size, and thus, the better approach is not to place 
such a limit on virtual group size. We will monitor the ways in which 
solo practitioners and groups with 10 or fewer eligible clinicians form 
virtual groups and may propose to establish appropriate classifications 
regarding virtual group composition or a limit on the number of TINs 
that may form a virtual group in future rulemaking as necessary.
    We solicited public comment on these proposals, as well as our 
approach of not establishing appropriate classifications (such as by 
geographic area or by specialty) regarding virtual group composition or 
a limit on the number of TINs that may form a virtual group at this 
time.
    We noted that we received public comments in response to the CY 
2017 Quality Payment Program final rule and additional stakeholder 
feedback by hosting several virtual group listening sessions and 
convening user groups (82 FR 30028). We refer readers to the CY 2018 
Quality Payment Program proposed rule (82 FR 30027) for a summary of 
these comments and our response.
    The following is a summary of the public comments received 
regarding our proposals, as well as our approach of not establishing 
appropriate classifications (such as by geographic area or by 
specialty) regarding virtual group composition or a limit on the number 
of TINs that may form a virtual group at this time.
    Comment: A majority of commenters supported the concept of virtual 
groups, as defined, as a participation option available under MIPS.
    Response: We appreciate the support from the commenters.
    Comment: Several commenters did not support virtual groups being 
limited to groups consisting of not more than 10 eligible clinicians 
and requested that CMS expand virtual group participation to groups 
with more than 10 eligible clinicians.
    Response: As noted above, we interpreted the references to a group 
``consisting of not more than 10'' MIPS eligible clinicians in section 
1848(q)(5)(I)(ii) of the Act to mean a group with 10 or fewer eligible 
clinicians (as such terms are defined at Sec.  414.1305) (82 FR 30027). 
We do not have discretion to expand virtual group participation to 
groups with more than 10 MIPS eligible clinicians.
    Comment: One commenter recommended that CMS seek a technical 
amendment to section 1848(q)(5)(I) of the Act to replace the group 
eligibility threshold of 10 or fewer MIPS eligible clinicians with a 
patient population requirement of at least 5,000 to improve the 
validity of the reporting of virtual groups.
    Response: We appreciate the feedback from the commenter and will 
take the commenter's recommendation into consideration.
    Comment: A few commenters recommended that CMS allow a large, 
multispecialty group under one TIN to split into clinically relevant 
reporting groups, or allow multiple TINs within a health care delivery 
system to report as a virtual group.
    Response: In the CY 2017 Quality Payment Program final rule (81 FR 
77058), we noted that except for groups containing APM participants, we 
do not permit groups to ``split'' TINs if they choose to participate in 
MIPS as a group. As we considered the option of permitting groups to 
split TINs, we identified several issues that would make it challenging 
and cumbersome to implement a split TIN option such as the 
administrative burden of groups having to monitor and track which NPIs 
are reporting under which portion of a split TIN and the identification 
of appropriate criteria to be used for determining the ways in which 
groups would be able to split TINs (for example, based on specialty, 
practice site, location, health IT systems, or other factors). However, 
we recognize that there are certain advantages for allowing TINs to 
split, such as those the identified by the commenter. We intend to 
explore the option of permitting groups to split TINs, and any changes 
would be proposed in future rulemaking. Thus, we consider a group to 
mean an entire single TIN that elects to participate in MIPS at the 
group or virtual group level. However, for multiple TINs that are 
within a health care delivery system, such TINs would be able to form a 
virtual group provided that each TIN has 10 or fewer eligible 
clinicians.
    Comment: A significant portion of commenters expressed concern 
regarding the ineligibility of virtual group participation for solo 
practitioners and groups that do not exceed the low-volume threshold. 
The commenters noted that such solo practitioners and groups would not 
be able to benefit from participating as part of a virtual group and 
noted that the purpose of virtual group formation was to provide such 
solo practitioners and groups, which are otherwise unable to 
participate on their own, with an opportunity to join with other such 
entities and collectively become eligible to participate in MIPS as 
part of a virtual group. A few commenters recommended that the low-
volume threshold be conducted at the virtual group level.
    Response: In regard to stakeholder concerns pertaining to the low-
volume threshold eligibility determinations made at the individual and 
group level that would prevent certain solo practitioners and groups 
from being eligible to form a virtual group, we believe there are 
statutory constraints that do not allow us to establish a low-

[[Page 53596]]

volume threshold at the virtual group level. The statute includes 
specific references to ``MIPS eligible clinicians'' throughout the 
virtual group provisions, and we believe that such references were 
intended to limit virtual group participation to ``MIPS eligible 
clinicians'', that is, eligible clinicians who meet the definition of a 
MIPS eligible clinician and are not excluded under the low-volume 
threshold or any other statutory exclusion. As a result, we do not 
believe we are able to establish a low-volume threshold at the virtual 
group level because a solo practitioner or group would need to be 
considered eligible to participate in MIPS to form or join a virtual 
group.
    Comment: Many commenters supported the flexibility provided for 
virtual group composition, such as to not have parameters pertaining to 
geographic area, specialty, size, or other factors, while other 
commenters had concerns that such flexibility could circumvent bona 
fide clinical reasons for collaboration, incentivize practice 
consolidation, and cause an increase in costs without improving quality 
and health outcomes.
    Response: We appreciate the support from the commenters regarding 
the flexibility we are providing to virtual groups pertaining to 
composition. In regard to concerns from other commenters regarding such 
flexibility, we note that TINs vary in size, clinician composition, 
patient population, resources, technological capabilities, geographic 
area, and other characteristics, and may join or form virtual groups 
for various reasons, and we do not want to inhibit virtual group 
formation due to parameters. At this juncture of virtual group 
implementation, we believe that virtual groups should have the 
flexibility to determine their composition and size, and thus we do not 
want to limit the ways in which virtual groups are composed. However, 
we encourage TINs within virtual groups to assess means for promoting 
and enhancing the coordination of care and improving the quality of 
care and health outcomes. We will monitor the ways in which solo 
practitioners and groups with 10 or fewer eligible clinicians form 
virtual groups and may propose to establish appropriate classifications 
regarding virtual group composition or a limit on the number of TINs 
that may form a virtual group in future rulemaking as necessary.
    Comment: One commenter requested that CMS continue to examine the 
formation and implementation of virtual groups, ensuring equity and 
taking into account variability in patient case-mix and practice needs.
    Response: We appreciate the feedback from the commenter and will 
take the commenter's recommendation into consideration.
    Comment: One commenter indicated that the Quality Payment Program 
encourages eligible clinicians to aggregate data, share financial risk, 
and work together as virtual groups, which promotes joint 
accountability and creates delivery systems that are better able to 
improve the cost, quality, and experience of care. As a result, the 
commenter recommended that CMS issue detailed guidance and develop 
tools, resources, technical assistance, and other materials for 
guidance as to how clinicians can form virtual groups.
    Response: We appreciate the feedback from the commenter and note 
that we intend to publish a virtual group toolkit that provides 
information pertaining to requirements and outlines the steps a virtual 
group would pursue during the election process, which can be accessed 
on the CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html.
    Comment: A few commenters recommended that only MIPS eligible 
clinicians be considered as part of a virtual group as written in the 
statute. The commenters indicated that CMS continues to include all 
eligible clinicians versus only MIPS eligible clinicians in the count 
to determine TIN size and requested that CMS instead rely on the ``not 
more than 10 MIPS eligible clinicians'' language in the statute, which 
would allow more groups to take advantage of the virtual group 
reporting option and focus more directly on the number of clinicians 
who are participating in and contributing to MIPS rather than 
clinicians who are excluded.
    Response: We note that our proposed definition of a virtual group 
reflects the statutory premise of virtual group participation 
pertaining to MIPS eligible clinicians. In the CY 2017 final rule (81 
FR 77539), we define a MIPS eligible clinician (identified by a unique 
billing TIN and NPI combination used to assess performance) at Sec.  
414.1305 to mean any of the following (excluding those identified at 
Sec.  414.1310(b)): (1) A physician as defined in section 1861(r) of 
the Act; (2) a physician assistant, a nurse practitioner, and clinical 
nurse specialist as such terms are defined in section 1861(aa)(5) of 
the Act; (3) a certified registered nurse anesthetist as defined in 
section 1861(bb)(2) of the Act; and (4) a group that includes such 
clinicians. The definition of a MIPS eligible clinician includes a 
group and we define a group at Sec.  414.1305 to mean 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. Since a group is included under the 
definition of a MIPS eligible clinician, which would include two or 
more eligible clinicians (including at least one MIPS eligible 
clinician), our definition of a virtual group is consistent with 
statute.
    In regard to determining TIN size for purposes of virtual group 
eligibility, we count each NPI associated with a TIN in order to 
determine whether or not a TIN exceeds the threshold of 10 NPIs, which 
is an approach that we believe provides continuity over time if the 
definition of a MIPS eligible clinician is expanded in future years 
under section 1848(q)(1)(C)(i)(II) of the Act to include other eligible 
clinicians. We considered an alternative approach for determining TIN 
size, which would determine TIN size for virtual group eligibility 
based on NPIs who are MIPS eligible clinicians. However, as we 
conducted a comparative assessment of the application of such 
alternative approach with the current definition of a MIPS eligible 
clinician (as defined at Sec.  414.1305) and a potential expanded 
definition of a MIPS eligible clinician, we found that such an approach 
could create confusion as to which factors determine virtual group 
eligibility and cause the pool of virtual group eligible TINs to 
significantly be reduced once the definition of a MIPS eligible 
clinician would be expanded, which may impact a larger portion of 
virtual groups that intend to participate in MIPS as a virtual group 
for consecutive performance periods. Such impact would be the result of 
the current definition of a MIPS eligible clinician being narrower than 
the potential expanded definition of a MIPS eligible clinician. For 
example, under the recommended approach, a TIN with a total of 15 NPIs 
(10 MIPS eligible clinicians and 5 eligible clinicians) would not 
exceed the threshold of 10 MIPS eligible clinicians and would be 
eligible to participate in MIPS as a virtual group for the 2018 
performance period; however, if the definition of a MIPS eligible 
clinician were expanded through rulemaking for the 2019 performance 
period, such TIN, with no change in TIN size (15 NPIs), would exceed 
the threshold of 10 MIPS eligible clinicians if 1 or more of the 5 
eligible clinicians met the expanded definition

[[Page 53597]]

of a MIPS eligible clinician and no longer eligible to participate in 
MIPS as part of a virtual group. We did not pursue such an approach 
given that it did not align with our objective of establishing virtual 
group eligibility policies that are simplistic in understanding and 
provide continuity.
    Final Action: After consideration of the public comments received, 
we are finalizing with modification our proposal to define a solo 
practitioner at Sec.  414.1305 as a practice consisting of one eligible 
clinician (who is also a MIPS eligible clinician). We are also 
finalizing with modification our proposal to define a virtual group at 
Sec.  414.1305 as a combination of two or more TINs assigned to one or 
more solo practitioners or one or more groups consisting of 10 or fewer 
eligible clinicians, or both, that elect to form a virtual group for a 
performance period for a year. We are modifying the definition (i) to 
remove the redundant phrases ``with at least one other such solo 
practitioner or group'' and unnecessary parenthetical cross references; 
(ii) to accurately characterize TINs as being ``assigned to'' (rather 
than ``composed of'') a solo practitioner or group; and (iii) to 
clearly indicate that a virtual group can be composed of ``one or 
more'' solo practitioners or groups of 10 or fewer eligible clinicians. 
We note that we are modifying our proposed definitions for greater 
clarity and consistency with established MIPS terminology.
    We are also finalizing our proposal that for groups (TINs) that 
participate in MIPS as part of a virtual group and do not contain 
participants in a MIPS APM or an Advanced APM, each MIPS eligible 
clinician under the TIN (each TIN/NPI) will receive a MIPS payment 
adjustment based on the virtual group's combined performance assessment 
(combination of TINs). For groups (TINs) that participate in MIPS as 
part of a virtual group and contain participants in a MIPS APM or an 
Advanced APM, only the portion of the TIN that is being scored for MIPS 
according to the generally applicable scoring criteria will receive a 
MIPS adjustment based on the virtual group's combined performance 
assessment (combination of TINs). As discussed in section II.C.6.g. of 
this final rule with comment period, the remaining portion of the TIN 
that is being scored according to the APM scoring standard will receive 
a MIPS payment adjustment based on that standard. We note that such 
participants may be excluded from MIPS if they achieve QP or Partial QP 
status.
    At this juncture, we are not establishing additional 
classifications (such as by geographic area or by specialty) regarding 
virtual group composition or a limit on the number of TINs that may 
form a virtual group.
c. Virtual Group Identifier for Performance
    To ensure that we have accurately captured all of the MIPS eligible 
clinicians participating in a virtual group, we proposed that each MIPS 
eligible clinician who is part of a virtual group would be identified 
by a unique virtual group participant identifier (82 FR 30028 through 
30029). The unique virtual group participant identifier would be a 
combination of three identifiers: (1) Virtual group identifier 
(established by CMS; for example, XXXXXX); (2) TIN (9 numeric 
characters; for example, XXXXXXXXX); and (3) NPI (10 numeric 
characters; for example, 1111111111). For example, a virtual 
participant identifier could be VG-XXXXXX, TIN-XXXXXXXXX, NPI-
11111111111. We solicited public comment on this proposal.
    The following is a summary of the public comments received 
regarding our proposal.
    Comment: A majority of commenters expressed support for our 
proposal.
    Response: We appreciate the support from the commenters.
    Comment: One commenter indicated that a virtual group identifier 
would lead to administrative simplification and more accurate 
identification of MIPS eligible clinicians caring for Medicare 
beneficiaries, which could be used in recognizing and eliminating 
redundancies in the payer system.
    Response: We appreciate the support from the commenter. We believe 
that our proposed virtual group identifier will accurately identify 
each MIPS eligible clinician participating in a virtual group and be 
easily implemented by virtual groups.
    Comment: One commenter thanked CMS for not requiring virtual groups 
to form new TINs, which would add to the administrative burden for 
entities electing to become virtual groups, while another commenter 
requested clarification regarding whether or not members of a virtual 
group would need to submit a Reassignment of Benefits Form (CMS-855R) 
to the MAC and reassign their billing rights to the elected virtual 
group.
    Response: We note that a virtual group is recognized as an official 
collective entity for reporting purposes, but is not a distinct legal 
entity for billing purposes. As a result, a virtual group does not need 
to establish a new TIN for purposes of participation in MIPS, nor does 
any eligible clinician in the virtual group need to reassign their 
billing rights to a new or different TIN.
    Comment: A few commenters indicated that EHR developers need to 
know the specifications for the virtual group identifier as soon as 
technically feasible in order for such specifications to be included in 
their development efforts and implemented early in 2018. One commenter 
indicated that qualified registries submit data at the TIN level for 
group reporting and that individual NPI data is effectively obscured, 
and requested clarification regarding the type of information qualified 
registries would report for virtual groups, such as the virtual group 
identifier alone (VG-XXXXXX) or the combination of all three 
identifiers (VG-XXXXXX, TIN-XXXXXXXXX, NPI-11111111111).
    Response: For a virtual groups that are determined to have met the 
virtual group formation criteria and approved to participate in MIPS as 
an identified official virtual group, we will notify official 
designated virtual group representatives of their official virtual 
group status and issue a virtual group identifier. We intend to notify 
virtual groups of their official status as close to the start of the 
performance period as technically feasible. Virtual groups will need to 
provide their virtual group identifiers to the third party 
intermediaries that will be submitting their performance data, such as 
qualified registries, QCDRs, and/or EHRs. Qualified registries, QCDRs, 
and EHRs will include the virtual group identifier alone (VG-XXXXXX) in 
the file submissions. For virtual groups that elect to participate in 
MIPS via the CMS Web Interface or administer the CAHPS for MIPS survey, 
they will register via the CMS Web Interface and include the virtual 
group identifier alone (VG-XXXXXX) during registration. We intend to 
update submission specifications prior to the start of the applicable 
submission period.
    Comment: One commenter expressed concerns regarding the burden of 
using a virtual group identifier and the added administrative 
complexity to the claims process of using layered identifiers and 
modifiers. The commenter requested that CMS simplify the reporting 
process for MIPS eligible clinicians, groups, and virtual groups rather 
than increase the administrative burden.
    Response: We appreciate the feedback from the commenter. We do not 
believe that the virtual group identifier would be burdensome for 
virtual groups to implement. We believe that our proposed virtual group 
identifier is the most appropriate and simple approach,

[[Page 53598]]

which will allow for the accurate identification of each MIPS eligible 
clinician participating in a virtual group and be easily implemented by 
virtual groups.
    Final Action: After consideration of the public comments received, 
we are finalizing our proposal that each MIPS eligible clinician who is 
part of a virtual group will be identified by a unique virtual group 
participant identifier, which will be a combination of three 
identifiers: (1) Virtual group identifier (established by CMS; for 
example, XXXXXX); (2) TIN (9 numeric characters; for example, 
XXXXXXXXX); and (3) NPI (10 numeric characters; for example, 
1111111111). For example, a virtual group participant identifier could 
be VG-XXXXXX, TIN-XXXXXXXXX, NPI-11111111111.
d. Application of Group-Related Policies to Virtual Groups
(1) Generally
    In the CY 2017 Quality Payment Program final rule (81 FR 77070 
through 77072), we finalized various requirements for groups under MIPS 
at Sec.  414.1310(e), under which groups electing to report at the 
group level are assessed and scored across the TIN for all four 
performance categories. In the CY 2018 Quality Payment Program proposed 
rule (82 FR 30029), we proposed to apply our previously finalized and 
proposed group-related policies to virtual groups, unless otherwise 
specified. We recognized that there are instances in which we may need 
to clarify or modify the application of certain previously finalized or 
proposed group-related policies to virtual groups, such as the 
definition of a non-patient facing MIPS eligible clinician; small 
practice, rural area and HPSA designations; and groups that contain 
participants in a MIPS APM or an Advanced APM (see section II.C.4.b. of 
this final rule with comment period). More generally, such policies may 
include, but are not limited to, those that require a calculation of 
the number of NPIs across a TIN (given that a virtual group is a 
combination of TINs), the application of any virtual group 
participant's status or designation to the entire virtual group, and 
the applicability and availability of certain measures and activities 
to any virtual group participant and to the entire virtual group.
    We refer readers to section II.C.4.d.(5) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(2) Application of Non-Patient Facing Status to Virtual Groups
    With regard to the applicability of the non-patient facing MIPS 
eligible clinician-related policies to virtual groups, in the CY 2017 
Quality Payment Program final rule (81 FR 77048 through 77049), we 
defined the term non-patient facing MIPS eligible clinician 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. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30021, 30029), we proposed to modify the 
definition of a non-patient facing MIPS eligible clinician to include 
clinicians in a virtual group, provided that more than 75 percent of 
the NPIs billing under the virtual group's TINs meet the definition of 
a non-patient facing individual MIPS eligible clinician during the non-
patient facing determination period. We noted that other policies 
previously established and proposed in the proposed rule for non-
patient facing groups would apply to virtual groups (82 FR 30029). For 
example, as discussed in section II.C.1.e. of this final rule with 
comment period, virtual groups determined to be non-patient facing 
would have their advancing care information performance category 
automatically reweighted to zero.
    We refer readers to section II.C.4.d.(5) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(3) Application of Small Practice Status to Virtual Groups
    With regard to the application of small practice status to virtual 
groups, in the CY 2017 Quality Payment Program final rule (81 FR 
77188), we defined the term small practices at Sec.  414.1305 as 
practices consisting of 15 or fewer clinicians and solo practitioners. 
In the CY 2018 Quality Payment Program proposed rule (82 FR 30019, 
30029), we proposed that a virtual group would be identified as a small 
practice if the virtual group does not have 16 or more eligible 
clinicians. In addition, we proposed for performance periods occurring 
in 2018 and future years to identify small practices by utilizing 
claims data; for performance periods occurring in 2018, we would 
identify small practices based on 12 months of data starting from 
September 1, 2016 to August 31, 2017 (82 FR 30019 through 30020). We 
refer readers to section II.C.1.c. of this final rule with comment 
period for the discussion of our proposal to identify small practices 
by utilizing claims data. We refer readers to section II.C.4.d.(3) of 
this final rule with comment period for the discussion regarding how 
small practice status would apply to virtual groups for scoring under 
MIPS.
    We refer readers to section II.C.4.d.(5) of this final rule with 
comment period for a summary of the public comments we received on our 
proposal to apply small practice status to virtual groups and our 
responses.
(4) Application of Rural Area and HSPA Practice Status to Virtual 
Groups
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30020 
through 30021), we proposed to determine rural area and HPSA practice 
designations at the individual, group, and virtual group level. 
Specifically, for performance periods occurring in 2018 and future 
years, we proposed that an individual MIPS eligible clinician, a group, 
or a virtual group with multiple practices under its TIN or TINs within 
a virtual group would be designated as a rural area or HPSA practice if 
more than 75 percent of NPIs billing under the individual MIPS eligible 
clinician or group's TIN or within a virtual group, as applicable, are 
designated in a ZIP code as a rural area or HPSA. We noted that other 
policies previously established and proposed in the proposed rule for 
rural area and HPSA groups would apply to virtual groups (82 FR 30029). 
We note that in section II.C.7.b.(1)(b) of this final rule with comment 
period, we describe our scoring proposals for practices that are in a 
rural area.
    We refer readers to section II.C.4.d.(5) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(5) Applicability and Availability of Measures and Activities to 
Virtual Groups
    As noted above, we proposed to apply our previously finalized and 
proposed group-related policies to virtual groups, unless otherwise 
specified (82 FR 30029). In particular, we recognized that the measures 
and activities applicable and available to groups would also be 
applicable and available to virtual groups. Virtual groups would be 
required to meet the reporting

[[Page 53599]]

requirements for each measure and activity, and the virtual group would 
be responsible for ensuring that their measure and activity data are 
aggregated across the virtual group (for example, across their TINs). 
We noted that other previously finalized and proposed group-related 
policies pertaining to the four performance categories would apply to 
virtual groups.
    The following is a summary of the public comments received 
regarding our proposals.
    Comment: Many commenters supported our proposal to generally apply 
MIPS group-related policies to virtual groups, unless otherwise 
specified. The commenters indicated that such alignment would ease 
undue administrative and reporting burden.
    Response: We appreciate the support from the commenters.
    Comment: Several commenters supported our proposal to modify the 
definition of a non-patient facing MIPS eligible clinician to include 
clinicians in a virtual group provided that more than 75 percent of the 
NPIs billing under the virtual group's TINs meet the definition of a 
non-patient facing individual MIPS eligible clinician.
    Response: We appreciate the support from the commenters.
    Comment: One commenter expressed support for our proposal that a 
virtual group would be identified as a small practice if the virtual 
group does not have 16 or more eligible clinicians, while another 
commenter expressed support for our proposal that a virtual group with 
more than 75 percent of the NPIs billing under the virtual group's TINs 
are in a ZIP code designated as a rural area or HPSA would be 
designated as a rural area or HPSA practice at the virtual group level.
    Response: We appreciate the support from the commenters regarding 
our proposals.
    Comment: Several commenters did not support our proposal that a 
virtual group would be identified as a small practice if the virtual 
group does not have 16 or more eligible clinicians. The commenters 
expressed concerns that the benefits of forming a virtual group could 
be outweighed by the loss of the proposed small practice bonus points 
for virtual groups with more than 15 eligible clinicians, and that the 
elimination of small practice bonus points for such virtual groups 
would undermine the establishment of small practice policies afforded 
to such entities in statute. The commenters indicated that the 
formation of virtual groups would involve substantial administrative 
burdens for small practices, and that each TIN within a virtual group 
would otherwise qualify as a small practice and should not lose the 
accommodations to which they would otherwise be entitled. The 
commenters suggested that any virtual group, regardless of size, be 
considered a small practice. The commenters further stated that small 
practices that just slightly exceed the low-volume threshold may have 
the most challenges and difficulty succeeding in the Quality Payment 
Program.
    Response: We note that virtual groups with 15 or fewer eligible 
clinicians will continue to be considered a small practice as a 
collective entity. The small practice status is applied based on the 
collective entity as a whole and not based on the small practice status 
of each TIN within a virtual group. If a virtual group has 16 or more 
eligible clinicians, it would not be considered to have a small 
practice status as a collective whole. We believe that our approach is 
consistent with statute and not unfair to small practices that are a 
part of virtual groups with 16 or more eligible clinicians. Section 
1848(q)(2)(B)(iii) of the Act specifically refers to small practices of 
15 or fewer clinicians, and we do not believe it is appropriate to 
apply such designation to a virtual group as a collective single entity 
when a virtual group has 16 or more eligible clinicians. We encourage 
small practices to weigh the benefit of the special provisions specific 
to small practices against the benefits of virtual group participation 
when considering whether to form a virtual group that has 16 or more 
eligible clinicians. We refer readers to section II.C.7.b.(1)(c) of 
this final rule with comment for the discussion regarding the scoring 
of small practices. We want to ensure that small practices have the 
ability to determine the most appropriate means for participating in 
MIPS, whether it be as individuals, as a group or part of a virtual 
group. The formation of virtual groups provides for a comprehensive 
measurement of performance, shared responsibility, and an opportunity 
to effectively and efficiently coordinate resources to achieve 
requirements under each performance category. A small practice may 
elect to join a virtual group in order to potentially increase their 
performance under MIPS or elect to participate in MIPS as a group and 
take advantage of other flexibilities and benefits afforded to small 
practices. We note that if a virtual group has 16 or more eligible 
clinicians, it will not be considered a small practice.
    Comment: A few commenters did not support our proposal that a 
virtual group with more than 75 percent of the NPIs billing under the 
virtual group's TINs are in a ZIP code designated as a rural area or 
HPSA would be designated as a rural area or HPSA practice at the 
virtual group level. The commenters requested that CMS reduce the 
threshold pertaining to rural area and HPSA practice status for virtual 
groups and recommended that a virtual group with more than 50 percent 
of the NPIs billing under a virtual group's TINs are in a ZIP code 
designated as a rural area or HPSA would be designated as a rural area 
or HPSA practice at the virtual group level.
    Response: We disagree with the recommendation from the commenters. 
In order for a virtual group to be designated as a rural area or HPSA 
practice, we believe that a significant portion of a virtual group's 
NPIs would need to be in a ZIP code designated as a rural area or HPSA. 
Our proposal provides a balance between requiring more than half of a 
virtual group's NPIs to have such designations and requiring all NPIs 
within a virtual group to have such designations. Also, our proposed 
threshold pertaining to rural area and HPSA practice status for virtual 
groups aligns with other group-related and virtual group policies, 
which creates continuity among policies and makes virtual group 
implementation easier for TINs forming virtual groups.
    Comment: One commenter urged CMS to eliminate the all-cause 
hospital readmission measure from the quality performance category 
score for virtual groups with 16 or more eligible clinicians. The 
commenter noted that virtual groups would be newly formed and unlikely 
to have the same infrastructure and care coordination functionality 
that established groups under a single TIN may have in place, and that 
factoring the all-cause hospital readmission measure into their score 
would be inappropriate.
    Response: We recognize that small practices, including solo 
practitioners, would not be assessed on the all-cause hospital 
readmission measure as individual TINs. However, we believe that the 
all-cause hospital readmission measure is an appropriate measure, when 
applicable, to assess performance under the quality performance 
category of virtual groups with 16 or more eligible clinicians that 
meet the case volume of 200 cases. For virtual groups that do not meet 
the minimum case volume of 200, the all-cause hospital readmission 
measure would not be scored. Also, we believe that our approach for 
assessing performance based on the all-cause hospital readmission 
measure for virtual groups with 16 or more eligible clinicians is 
appropriate because it reflects the same

[[Page 53600]]

policy for groups, which was developed as a requirement to reduce 
burden (such measure is based on administrative claims data and does 
not require a separate submission of data) and ensure that we do not 
unfairly penalize MIPS eligible clinicians or groups that did not have 
adequate time to prepare adequately to succeed in the program while 
still rewarding high performers.
    Comment: One commenter supported our proposal to generally apply 
our group-related policies to virtual groups, specifically with regard 
to the improvement activities performance category requirements, under 
which groups and virtual groups would receive credit for an improvement 
activity as long as one NPI under the group's TIN or virtual group's 
TINs performs an improvement activity for a continuous 90-day period.
    Response: We appreciate the support from the commenter.
    Comment: One commenter requested clarification regarding how the 
proposed group-related policy that at least 50 percent of the practice 
sites within a TIN must be certified or recognized as a patient-
centered medical home or comparable specialty practice in order to 
receive full credit in the improvement activities performance category 
applies to virtual groups. Another commenter recommended that a virtual 
group receive full credit for the improvement activities performance 
category if at least 50 percent of its eligible clinicians are 
certified or recognized as a patient-centered medical home or 
comparable specialty practice.
    Response: As discussed in section II.C.7.a.(5)(c) of this final 
rule with comment period, in order for a group to receive full credit 
as a certified or recognized patient-centered medical home or 
comparable specialty practice under the improvement activities 
performance category, at least 50 percent of the practice sites within 
the TIN must be recognized as a patient-centered medical home or 
comparable specialty practice. In order for a virtual group to receive 
full credit as a certified or recognized patient-centered medical home 
or comparable specialty practice under the improvement activities 
performance category, at least 50 percent of the practice sites within 
the TINs that are part of a virtual group must be certified or 
recognized as a patient-centered medical home or comparable specialty 
practice.
    Comment: One commenter requested that CMS clarify how a virtual 
group would be expected to meet the advancing care information 
performance category requirements and whether all TINs within a virtual 
group would be required to have certified EHR technology.
    Response: In general and unless stated otherwise, for purposes of 
the advancing care information performance category, the policies 
pertaining to groups will apply to virtual groups. We refer readers to 
section II.C.6.f. of this final rule with comment period for more 
information on the generally applicable policies for the advancing care 
information performance category.
    We note that as with virtual group reporting for the other MIPS 
performance categories, to report as a virtual group, the virtual group 
will need to aggregate data for all of the individual MIPS eligible 
clinicians within the virtual group for which its TINs have data in 
CEHRT. For solo practitioners and groups that choose to report as a 
virtual group, performance on the advancing care information 
performance category objectives and measures will be reported and 
evaluated at the virtual group level. The virtual group will submit the 
data that its TINs have utilizing CEHRT and exclude data not collected 
from a non-certified EHR system. While we do not expect that every MIPS 
eligible clinician in a virtual group will have access to CEHRT, or 
that every measure will apply to every clinician in the virtual group, 
only those data contained in CEHRT should be reported for the advancing 
care information performance category.
    For example, the virtual group calculation of the numerators and 
denominators for each measure must reflect all of the data from the 
individual MIPS eligible clinicians (unless a clinician can be 
excluded) that have been captured in CEHRT for the given advancing care 
information performance category measure. If the groups (not including 
solo practitioners) that are part of a virtual group have CEHRT that is 
capable of supporting group level reporting, the virtual group would 
submit the aggregated data across the TINs produced by the CEHRT. If a 
group (TIN) that is part of a virtual group does not have CEHRT that is 
capable of supporting group level reporting, such group would aggregate 
the data by adding together the numerators and denominators for each 
MIPS eligible clinician within the group for whom the group has data 
captured in CEHRT. If an individual MIPS eligible clinician meets the 
criteria to exclude a measure, their data can be excluded from the 
calculation of that particular measure only.
    We recognize that it can be difficult to identify unique patients 
across a virtual group for the purposes of aggregating data on the 
advancing care information performance category measures, particularly 
when TINs within a virtual group may be using multiple CEHRT systems. 
For the 2018 performance period, TINs within virtual groups may be 
using systems which are certified to different CEHRT Editions. We 
consider ``unique patients'' to be individual patients treated by a TIN 
within a virtual group who would typically be counted as one patient in 
the denominator of an advancing care information performance category 
measure. This patient may see multiple MIPS eligible clinicians within 
a TIN that is part of a virtual group, or may see MIPS eligible 
clinicians at multiple practice sites of a TIN that is part of a 
virtual group. When aggregating performance on advancing care 
information measures for virtual group level reporting, we do not 
require that a virtual group determines that a patient seen by one MIPS 
eligible clinician (or at one location in the case of TINs working with 
multiple CEHRT systems) is not also seen by another MIPS eligible 
clinician in the TIN that is part of the virtual group or captured in a 
different CEHRT system. Virtual groups are provided with some 
flexibility as to the method for counting unique patients in the 
denominators to accommodate such scenarios where aggregation may be 
hindered by systems capabilities across multiple CEHRT platforms. We 
refer readers to section II.C.6.f.(4) of this final rule with comment 
for the discussion regarding certification requirements.
    Comment: One commenter requested that CMS require that a majority 
of eligible clinicians within a virtual group participate in activities 
to which the virtual group attests in the improvement activities and 
advancing care information performance categories in order for the 
virtual group to receive credit for those activities.
    Response: We note that a virtual group would need to meet the 
group-related requirements under each performance category. For the 
improvement activities performance category, a virtual group would meet 
the reporting requirements if at least one NPI within the virtual group 
completed an improvement activity for a minimum of a continuous 90-day 
period within CY 2018. In regard to the advancing care information 
performance category, a virtual group would need to fulfill the 
required base score measures for a minimum of 90 days in order to earn 
points for the advancing care information performance category. 
Additionally, virtual groups are able to submit performance score 
measures and bonus score measures in order to

[[Page 53601]]

increase the number of points earned under the advancing care 
information performance category.
    Comment: A few commenters requested that virtual groups have the 
same flexibility afforded to groups regarding the ability to report on 
different measures and utilize multiple submission mechanisms under 
each performance category.
    Response: We note that virtual groups will have the same 
flexibility as groups to report on measures and activities that are 
applicable and available to them. As discussed in section II.C.6.a.(1) 
of this final rule with comment period, the submission mechanisms 
available to groups under each performance category will also be 
available to virtual groups. Similarly, virtual groups will also have 
the same option as groups to utilize multiple submission mechanisms, 
but only one submission mechanism per performance category for the 2018 
performance period. However, starting with the 2019 performance period, 
groups and virtual groups will be able to utilize multiple submission 
mechanisms for each performance category.
    Comment: A few commenters recommended that CMS establish 
performance feedback for virtual groups and each TIN within a virtual 
group that includes complete performance data for each performance 
category. One commenter requested that CMS provide instructions 
regarding the appeal and audit process for virtual groups and TINs 
within a virtual group.
    Response: We note that performance feedback for virtual groups will 
be similar to feedback reports for groups, which is based on the 
performance of the entire group for each performance category. We note 
that virtual groups are required to aggregate their data across the 
virtual group, and will be assessed and scored at the virtual group 
level. Each TIN within the virtual group will receive feedback on their 
performance based on participation in MIPS as a virtual group, in which 
each TIN under the virtual group will have the same performance 
feedback applicable to the four performance categories. At this 
juncture, it is not technically feasible nor do we believe it is 
appropriate for us to de-aggregate data at the virtual group level and 
reassess performance data at the TIN or TIN/NPI level without requiring 
TINs and/or TIN/NPIs to submit data separately. We refer readers to 
section II.C.9.a. of this final rule with comment period for the 
discussion pertaining to performance feedback.
    Moreover, we note that virtual groups will have an opportunity to 
request a targeted review of their MIPS payment adjustment factor(s) 
for a performance period. In regard to an audit process, virtual groups 
would be subject to the MIPS data validation and auditing requirements 
as described in section II.C.9.c. of this final rule with comment 
period.
    Final Action: After consideration of public comments received, we 
are finalizing our proposal to apply our previously finalized and 
proposed group-related policies to virtual groups, unless otherwise 
specified.
    We are also finalizing our proposal to modify the definition of a 
non-patient facing MIPS eligible clinician at Sec.  414.1305 to include 
a virtual group, provided that more than 75 percent of the NPIs billing 
under the virtual group's TINs meet the definition of a non-patient 
facing individual MIPS eligible clinician during the non-patient facing 
determination period. Other previously finalized and proposed policies 
related to non-patient facing MIPS eligible clinicians would apply to 
such virtual groups.
    We are also finalizing our proposal that a virtual group will be 
considered a small practice if a virtual group consists of 15 or fewer 
eligible clinicians. Other previously finalized and proposed policies 
related to small practices would apply to such virtual groups.
    We are also finalizing our proposal that a virtual group will be 
designated as a rural area or HPSA practice if more than 75 percent of 
NPIs billing under the virtual group's TINs are designated in a ZIP 
code as a rural area or HPSA, the virtual group's TINs are designated 
as rural areas or HPSA practices. Other previously finalized and 
proposed policies related to rural area or HPSA practices would apply 
to such virtual groups.
    In response to public comments, we are also finalizing that a 
virtual group will be considered a certified or recognized patient-
centered medical home or comparable specialty practice under Sec.  
414.1380(b)(3)(iv) if at least 50 percent of the practices sites within 
the TINs are certified or recognized as a patient-centered medical home 
or comparable specialty practice.
e. Virtual Group Election Process
(1) Generally
    As noted in section II.C.4.a. of this final rule with comment 
period, section 1848(q)(5)(I)(iii)(I) and (II) of the Act provides that 
the virtual group election process must include certain requirements, 
including that: (1) An individual MIPS eligible clinician or group 
electing to be in a virtual group must make their election prior to the 
start of the applicable performance period and cannot change their 
election during the performance period; and (2) an individual MIPS 
eligible clinician or group may elect to be in no more than one virtual 
group for a performance period, and, in the case of a group, the 
election applies to all MIPS eligible clinicians in the group. 
Accordingly, we proposed to codify at Sec.  414.1315(a) that a solo 
practitioner (as defined at Sec.  414.1305) or group consisting of 10 
or fewer eligible clinicians (as such terms are defined at Sec.  
414.1305) electing to be in a virtual group must make their election 
prior to the start of the applicable performance period and cannot 
change their election during the performance period (82 FR 30029 
through 30030). Virtual group participants may elect to be in no more 
than one virtual group for a performance period, and, in the case of a 
group, the election applies to all MIPS eligible clinicians in the 
group.
    We noted that in the case of a TIN within a virtual group being 
acquired or merged with another TIN, or no longer operating as a TIN 
(for example, a group practice closes), during a performance period, 
such solo practitioner's or group's performance data would continue to 
be attributed to the virtual group (82 FR 30032). The remaining parties 
to the virtual group would continue to be part of the virtual group 
even if only one solo practitioner or group remains. We consider a TIN 
that is acquired or merged with another TIN, or no longer operating as 
a TIN (for example, a group practice closes), to mean a TIN that no 
longer exists or operates under the auspices of such TIN during a 
performance period.
    In order to provide support and reduce burden, we intend to make 
technical assistance (TA) available, to the extent feasible and 
appropriate, to support clinicians who choose to come together as a 
virtual group. Clinicians can access the TA infrastructure and 
resources that they may already be utilizing. For Quality Payment 
Program year 3, we intend to provide an electronic election process if 
technically feasible. We proposed that clinicians who do not elect to 
contact their designated TA representative would still have the option 
of contacting the Quality Payment Program Service Center to obtain 
information pertaining to virtual groups (82 FR 30030).
    We refer readers to section II.C.4.e.(3) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.

[[Page 53602]]

(2) Virtual Group Election Deadline
    For performance periods occurring in 2018 future years, we proposed 
to establish a virtual group election period (82 FR 30030). 
Specifically, we proposed to codify at Sec.  414.1315(a) that a solo 
practitioner (as defined at Sec.  414.1305) or group consisting of 10 
or fewer eligible clinicians (as such terms are defined at Sec.  
414.1305) electing to be in a virtual group must make their election by 
December 1 of the calendar year preceding the applicable performance 
period. A virtual group representative would be required to make the 
election, on behalf of the members of a virtual group, regarding the 
formation of a virtual group for the applicable performance period, by 
the election deadline. For example, a virtual group representative 
would need to make an election, on behalf of the members of a virtual 
group, by December 1, 2017 for the members of the virtual group to 
participate in MIPS as a virtual group during the CY 2018 performance 
period. We intend to publish the beginning date of the virtual group 
election period applicable to performance periods occurring in 2018 and 
future years in subregulatory guidance.
    We refer readers to section II.C.4.e.(3) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(3) Virtual Group Eligibility Determinations and Formation
    We proposed to codify at Sec.  414.1315(c) a two-stage virtual 
group election process, stage 1 of which is optional, for performance 
periods occurring in 2018 and 2019 (82 FR 30030 through 30032). Stage 1 
pertains to virtual group eligibility determinations, and stage 2 
pertains to virtual group formation. We noted that activity involved in 
stage 1 is not required, but a resource available to solo practitioners 
and groups with 10 or fewer eligible clinicians. Solo practitioners and 
groups that engage in stage 1 and are determined eligible for virtual 
group participation would proceed to stage 2; otherwise, solo 
practitioners and groups that do not engage in any activity during 
stage 1 would begin the election process at stage 2. Engaging in stage 
1 would provide solo practitioners and groups with the option to 
confirm whether or not they are eligible to join or form a virtual 
group before going to the lengths of executing formal written 
agreements, submitting a formal election registration, allocating 
resources for virtual group implementation, and other related 
activities; whereas, by engaging directly in stage 2 as an initial 
step, solo practitioners and groups might conduct all such efforts to 
only have their election registration be rejected with no recourse or 
remaining time to amend and resubmit.
    In stage 1, solo practitioners and groups with 10 or fewer eligible 
clinicians interested in forming or joining a virtual group would have 
the option to contact their designated TA representative in order to 
obtain information pertaining to virtual groups and/or determine 
whether or not they are eligible, as it relates to the practice size 
requirement of a solo practitioner or a group of 10 or fewer eligible 
clinicians, to participate in MIPS as a virtual group (Sec.  
414.1315(c)(1)(i)). During stage 1 of the virtual group election 
process, we would determine whether or not a TIN is eligible to form or 
join a virtual group. In order for a solo practitioner to be eligible 
to form or join a virtual group, the solo practitioner would need to 
meet the definition of a solo practitioner at Sec.  414.1305 and not be 
excluded from MIPS under Sec.  414.1310(b) or (c). In order for a group 
to be eligible to form or join a virtual group, a group would need to 
meet the definition of a group at Sec.  414.1305, have a TIN size that 
does not exceed 10 eligible clinicians, and not be excluded from MIPS 
under Sec.  414.1310(b) or (c). For purposes of determining TIN size 
for virtual group participation eligibility, we coined the term 
``virtual group eligibility determination period'' and defined it to 
mean an analysis of claims data during an assessment period of up to 5 
months that would begin on July 1 and end as late as November 30 of the 
calendar year prior to the applicable performance period and includes a 
30-day claims run out.
    To capture a real-time representation of TIN size, we proposed to 
analyze up to 5 months of claims data on a rolling basis, in which 
virtual group eligibility determinations for each TIN would be updated 
and made available monthly (82 FR 30030). We noted that an eligibility 
determination regarding TIN size is based on a relative point in time 
within the 5-month virtual group eligibility determination period, and 
not made at the end of such 5-month determination period.
    If at any time a TIN is determined to be eligible to participate in 
MIPS as part of a virtual group, the TIN would retain that status for 
the duration of the election period and the applicable performance 
period. TINs could determine their status by contacting their 
designated TA representative; otherwise, the TIN's status would be 
determined at the time that the TIN's virtual group election is 
submitted. For example, if a group contacted their designated TA 
representative on October 20, 2017, the claims data analysis would 
include the months of July through September of 2017, and, if 
determined not to exceed 10 eligible clinicians, the TIN's size would 
be determined at such time, and the TIN's eligibility status would be 
retained for the duration of the election period and the CY 2018 
performance period. If another group contacted their designated TA 
representative on November 20, 2017, the claims data analysis would 
include the months of July through October of 2017, and, if determined 
not to exceed 10 eligible clinicians, the TIN's size would be 
determined at such time, and the TIN's eligibility status would be 
retained for the duration of the election period and the CY 2018 
performance period.
    We believe such a virtual group determination period process 
provides a relative representation of real-time TIN size for purposes 
of virtual group eligibility and allows solo practitioners and groups 
to know their real-time eligibility status immediately and plan 
accordingly for virtual group implementation. It is anticipated that 
starting in September of each calendar year prior to the applicable 
performance period, solo practitioners and groups would be able to 
contact their designated TA representative and inquire about virtual 
group participation eligibility. We noted that TIN size determinations 
are based on the number of NPIs associated with a TIN, which would 
include clinicians (NPIs) who do not meet the definition of a MIPS 
eligible clinician at Sec.  414.1305 or who are excluded from MIPS 
under Sec.  414.1310(b) or (c).
    For groups that do not choose to participate in stage 1 of the 
election process (that is, the group does not request an eligibility 
determination), we will make an eligibility determination during stage 
2 of the election process. If a group began the election process at 
stage 2 and if its TIN size is determined not to exceed 10 eligible 
clinicians and not excluded based on the low-volume threshold exclusion 
at the group level, the group is determined eligible to participate in 
MIPS as part of a virtual group, and such virtual group eligibility 
determination status would be retained for the duration of the election 
period and applicable performance period. Stage 2 pertains to virtual 
group formation. For stage two, we proposed the following (82 FR 
30031):

[[Page 53603]]

     TINs comprising a virtual group must establish a written 
formal agreement between each member of a virtual group prior to an 
election (Sec.  414.1315(c)(2)(i)).
     On behalf of a virtual group, the official designated 
virtual group representative must submit an election by December 1 of 
the calendar year prior to the start of the applicable performance 
period (Sec.  414.1315(c)(2)(ii)). Such election will occur via email 
to the Quality Payment Program Service Center using the following email 
address for the 2018 and 2019 performance periods: 
[email protected].
     The submission of a virtual group election must include, 
at a minimum, information pertaining to each TIN and NPI associated 
with the virtual group and contact information for the virtual group 
representative (Sec.  414.1315(c)(2)(iii)). A virtual group 
representative would submit the following type of information: Each TIN 
associated with the virtual group; each NPI associated with a TIN that 
is part of the virtual group; name of the virtual group representative; 
affiliation of the virtual group representative to the virtual group; 
contact information for the virtual group representative; and 
confirmation through acknowledgment that a formal written agreement has 
been established between each member of the virtual group (solo 
practitioner or group) prior to election and each eligible clinician in 
the virtual group is aware of participating in MIPS as a virtual group 
for an applicable performance period. Each party to the virtual group 
agreement must retain a copy of the virtual group's written agreement. 
We noted that the virtual group agreement is subject to the MIPS data 
validation and auditing requirements as described in section II.C.9.c. 
of this final rule with comment period.
     Once an election is made, the virtual group representative 
must contact their designated CMS contact to update any election 
information that changed during an applicable performance period at 
least one time prior to the start of an applicable submission period 
(Sec.  414.1315(c)(2)(iv)). Virtual groups will use the Quality Payment 
Program Service Center as their designated CMS contact; however, we 
will define this further in subregulatory guidance.
    For stage 2 of the election process, we would review all submitted 
election information; confirm whether or not each TIN within a virtual 
group is eligible to participate in MIPS as part of a virtual group; 
identify the NPIs within each TIN participating in a virtual group that 
are excluded from MIPS in order to ensure that such NPIs would not 
receive a MIPS payment adjustment or, when applicable and when 
information is available, would receive a payment adjustment based on a 
MIPS APM scoring standard; calculate the low-volume threshold at the 
individual and group levels in order to determine whether or not a solo 
practitioner or group is eligible to participate in MIPS as part of a 
virtual group; and notify virtual groups as to whether or not they are 
considered official virtual groups for the applicable performance 
period. For virtual groups that are determined to have met the virtual 
group formation criteria and identified as an official virtual group 
participating in MIPS for an applicable performance period, we would 
contact the official designated virtual group representative via email 
notifying the virtual group of its official virtual group status and 
issuing a virtual group identifier for performance (as described in 
section II.C.4.c. of this final rule with comment period) that would 
accompany the virtual group's submission of performance data during the 
submission period.
    As we engaged in various discussions with stakeholders during the 
rulemaking process through listening sessions and user groups, 
stakeholders indicated that many solo practitioners and small groups 
have limited resources and technical capacities, which may make it 
difficult for the entities to form virtual groups without sufficient 
time and technical assistance. Depending on the resources and technical 
capacities of the entities, stakeholders conveyed that it may take 
entities 3 to 18 months to prepare to participate in MIPS as a virtual 
group. The majority of stakeholders indicated that virtual groups would 
need at least 6 to 12 months prior to the start of the CY 2018 
performance period to form virtual groups, prepare health IT systems, 
and train staff to be ready for the implementation of virtual group 
related activities by January 1, 2018.
    We recognized that for the first year of virtual group formation 
and implementation prior to the start of the CY 2018 performance 
period, the timeframe for virtual groups to make an election by 
registering would be relatively short, particularly from the date we 
issue the publication of a final rule toward the end of the 2017 
calendar year. To provide solo practitioners and groups with 10 or 
fewer eligible clinicians with additional time to assemble and 
coordinate resources, and form a virtual group prior to the start of 
the CY 2018 performance period, we provided virtual groups with an 
opportunity to make an election prior to the publication of our final 
rule. On October 11, 2017, the election period began and we issued 
information pertaining to the start date of the election process via 
subregulatory guidance, which can be accessed on the CMS Web site at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html. As discussed in section II.C.4.e. of this final rule with 
comment period, we are extending the virtual group election. Virtual 
groups would have from October 11, 2017 to December 31, 2017 to make an 
election for the 2018 performance year. However, any MIPS eligible 
clinicians applying to be a virtual group that does not meet all 
finalized virtual group requirements would not be permitted to 
participate in MIPS as a virtual group.
    As previously noted, solo practitioners and groups participating in 
a virtual group would have the size of their TIN determined for 
eligibility purposes. We recognized that the size of a TIN may 
fluctuate during a performance period with eligible clinicians and/or 
MIPS eligible clinicians joining or leaving a group. For solo 
practitioners and groups that are determined eligible to form or join a 
virtual group based on the one-time determination per applicable 
performance period, any new eligible clinicians or MIPS eligible 
clinicians that join the TIN during the performance period would 
participate in MIPS as part of the virtual group. In such cases, we 
recognized that a solo practitioner or group may exceed 1 eligible 
clinician or 10 eligible clinicians, as applicable, associated with its 
TIN during an applicable performance period, but such solo practitioner 
or group would have been determined eligible to form or join a virtual 
group given that the TIN did not have more than 1 eligible clinician or 
10 eligible clinicians, as applicable, associated with its TIN at the 
time of election. As previously noted, the virtual group representative 
would need to contact the Quality Payment Program Service Center to 
update the virtual group's information that was provided during the 
election period if any information changed during an applicable 
performance period at least one time prior to the start of an 
applicable submission period (for example, include new NPIs who joined 
a TIN that is part of a virtual group).

[[Page 53604]]

Virtual groups must re-register before each performance period.
    The following is a summary of the public comments received 
regarding our proposed election process for virtual groups.
    Comment: Generally, all commenters expressed support for the 
technical assistance infrastructure and two-stage election process.
    Response: We appreciate the support from commenters.
    Comment: A majority of commenters expressed concern regarding the 
election deadline of December 1, while several commenters recommended 
that an election deadline be established during the performance period 
in order for virtual groups to have the adequate and necessary time to 
prepare for the implementation of virtual groups, including the 
establishment and execution of formal written agreements and 
coordination within virtual groups to address issues pertaining to 
interoperability, measure selection, data collection and aggregation, 
measure specifications, workflows, resources, and other related items. 
A few commenters recommended an election deadline of June 30 to align 
with the election deadline for groups and virtual groups to register to 
use the CMS Web Interface and/or administer the CAHPS for MIPS survey.
    Response: We appreciate the feedback from commenters regarding the 
election deadline of December 1 and note that section 
1848(q)(5)(I)(iii)(I) of the Act provides that the virtual group 
election process must require an individual MIPS eligible clinician or 
group electing to be in a virtual group to make their election prior to 
the start of the applicable performance period. Given that the CY 
performance period for the quality and cost performance categories 
begins on January 1, a solo practitioner or group electing to be in a 
virtual group would need to make their election prior to January 1. As 
a result, we are modifying our proposed election deadline by extending 
it to December 31 of the calendar year preceding the applicable 
performance period. We note that our proposed election deadline of 
December 1 was intended to allow us to notify virtual groups of their 
official status prior to the start of the performance period. With the 
modification we are finalizing for the election deadline of December 
31, it is not operationally feasible for us to notify virtual groups of 
their official virtual group status prior to the start of the 
performance period. However, we intend to notify virtual groups of 
their official status as close to the start of the performance period 
as technically feasible.
    Comment: A few commenters indicated that solo practitioners and 
groups should have the option of leaving a virtual group during the 
performance period or allow a virtual group to remove a solo 
practitioner or group for non-compliance or low performance.
    Response: We note that the statute specifies that a virtual group 
election cannot be changed during the performance period, and such 
election would remain for the duration of the performance period.
    Comment: A few commenters requested that CMS allow virtual group 
agreements to be executed during the performance period in order to 
provide the virtual group parties with time to establish goals and 
objectives, build relationships with each other, and identify 
additional agreement provisions that may be necessary to include in 
order to meet program requirements.
    Response: We note that section 1848(q)(5)(I)(iii)(I) and (IV) of 
the Act provides that the virtual group election process must require 
an individual MIPS eligible clinician or group electing to be in a 
virtual group to make their election prior to the start of the 
applicable performance period, and include requirements providing for 
formal written agreements among individual MIPS eligible clinicians and 
groups electing to be a virtual group. Thus, we are not authorized to 
establish an agreement deadline during the performance period. However, 
we note that the parties to a virtual group agreement would not be 
precluded from amending their agreement during the performance period, 
which enables them to incorporate any additional agreement provisions 
that they later identify as necessary. A virtual group representative 
would notify CMS of the implementation and execution of an amended 
virtual group agreement.
    Final Action: After consideration of the public comments received, 
we are finalizing the following policies. We are codifying at Sec.  
414.1315(a) that a solo practitioner or a group of 10 or fewer eligible 
clinicians must make their election to participate in MIPS as a virtual 
group prior to the start of the applicable performance period and 
cannot change their election during the performance period; and 
codifying at Sec.  414.1315(c) a two-stage virtual group election 
process, stage 1 of which is optional, for the applicable 2018 and 2019 
performance periods. We are finalizing a modification to our proposed 
election period deadline by codifying at Sec.  414.1315(b) that, 
beginning with performance periods occurring in 2018, a solo 
practitioner, or group of 10 or fewer eligible clinicians electing to 
be in a virtual group must make their election by December 31 of the 
calendar year preceding the applicable performance period.
f. Virtual Group Agreements
    As noted in section II.C.4.a. of this final rule with comment 
period, section 1848(q)(5)(I)(iii)(IV) of the Act provides that the 
virtual group election process must provide for formal written 
agreements among individual MIPS eligible clinicians (solo 
practitioners) and groups electing to be a virtual group. We proposed 
that each virtual group member (that is, each solo practitioner or 
group) would be required to execute formal written agreements with each 
other virtual group member to ensure that requirements and expectations 
of participation in MIPS are clearly articulated, understood, and 
agreed upon (82 FR 30032 through 30033). We noted that a virtual group 
may not include a solo practitioner or group as part of the virtual 
group unless an authorized person of the TIN has executed a formal 
written agreement. During the election process and submission of a 
virtual group election, a designated virtual group representative would 
be required to confirm through acknowledgement that an agreement is in 
place between each member of the virtual group. An agreement would be 
executed for at least one performance period. If an NPI joins or leaves 
a TIN, or a change is made to a TIN that impacts the agreement itself, 
such as a legal business name change, during the applicable performance 
period, a virtual group would be required to update the agreement to 
reflect such changes and submit changes to CMS via the Quality Payment 
Program Service Center.
    We proposed, at Sec.  414.1315(c)(3), that a formal written 
agreement between each member of a virtual group must include the 
following elements:
     Expressly state the only parties to the agreement are the 
TINs and NPIs of the virtual group (at Sec.  414.1315(c)(3)(i)). For 
example, the agreement may not be between a virtual group and another 
entity, such as an independent practice association (IPA) or management 
company that in turn has an agreement with one or more TINs within the 
virtual group. Similarly, virtual groups should not use existing 
contracts between TINs that include third parties.
     Be executed on behalf of the TINs and the NPIs by 
individuals who are authorized to bind the TINs and the

[[Page 53605]]

NPIs, respectively at Sec.  414.1315(c)(3)(ii)).
     Expressly require each member of the virtual group 
(including each NPI under each TIN) to agree to participate in MIPS as 
a virtual group and comply with the requirements of the MIPS and all 
other applicable laws and regulations (including, but not limited to, 
federal criminal law, False Claims Act, anti-kickback statute, civil 
monetary penalties law, the Health Insurance Portability and 
Accountability Act of 1996, and physician self-referral law) (at Sec.  
414.1315(c)(3)(iii)).
     Require each TIN within a virtual group to notify all NPIs 
associated with the TIN of their participation in the MIPS as a virtual 
group (at Sec.  414.1315(c)(3)(iv)).
     Set forth the NPI's rights and obligations in, and 
representation by, the virtual group, including without limitation, the 
reporting requirements and how participation in MIPS as a virtual group 
affects the ability of the NPI to participate in the MIPS outside of 
the virtual group (at Sec.  414.1315(c)(3)(v)).
     Describe how the opportunity to receive payment 
adjustments will encourage each member of the virtual group (including 
each NPI under each TIN) to adhere to quality assurance and improvement 
(at Sec.  414.1315(c)(3)(vi)).
     Require each member of the virtual group to update its 
Medicare enrollment information, including the addition and deletion of 
NPIs billing through a TIN that is part of a virtual group, on a timely 
basis in accordance with Medicare program requirements and to notify 
the virtual group of any such changes within 30 days after the change 
(at Sec.  414.1315(c)(3)(vii)).
     Be for a term of at least one performance period as 
specified in the formal written agreement (at Sec.  
414.1315(c)(3)(viii)).
     Require completion of a close-out process upon termination 
or expiration of the agreement that requires the TIN (group part of the 
virtual group) or NPI (solo practitioner part of the virtual group) to 
furnish, in accordance with applicable privacy and security laws, all 
data necessary in order for the virtual group to aggregate its data 
across the virtual group (at Sec.  414.1315(c)(3)(ix)).
    On August 18, 2017, we published a 30-day Federal Register notice 
(82 FR 39440) announcing our formal submission of the information 
collection request (ICR) for the virtual group election process to OMB, 
which included a model formal written agreement, and informing the 
public on its additional opportunity to review the ICR and submit 
comments by September 18, 2017. OMB approved the ICR on September 27, 
2017 (OMB control number 0938-1343). The model formal written agreement 
is not required, but serves as a template that virtual groups could 
utilize in establishing an agreement with each member of a virtual 
group. Such agreement template will be made available via subregulatory 
guidance. Each prospective virtual group member should consult their 
own legal and other appropriate counsel as necessary in establishing 
the agreement.
    We want to ensure that all eligible clinicians who bill through the 
TINs that are components of a virtual group are aware of their 
participation in a virtual group. We want to implement an approach that 
considers a balance between the need to ensure that all eligible 
clinicians in a group are aware of their participation in a virtual 
group and the minimization of administration burden.
    We solicited public comment on these proposals and on approaches 
for virtual groups to ensure that all eligible clinicians in a group 
are aware of their participation in a virtual group.
    The following is a summary of the public comments received 
regarding our proposal to require formal written agreement between each 
member of a virtual group.
    Comment: Several commenters expressed support for the proposed 
provisions that virtual groups would need to include as part of the 
formal written agreement establishing a virtual group.
    Response: We appreciate the support from commenters.
    Comment: A few commenters expressed concern regarding the burden 
associated with the agreements required for virtual group 
implementation and execution. One commenter indicated that the formal 
written agreement process, while essential to allow for data capture, 
poses administrative burden and other complexities when utilizing 
multiple submission mechanisms.
    Response: We note that section 1848(q)(5)(I)(iii)(IV) of the Act 
provides that the virtual group election process must provide for 
``formal written agreements among MIPS eligible professionals'' (that 
is, individual MIPS eligible clinicians and groups) that elect to be a 
virtual group. As such, we do not believe that our proposal to require 
a written agreement governing the virtual group is excessively 
burdensome. However, although we believe the agreements should identify 
each eligible clinician billing under the TIN of a practice within the 
virtual group, we have concluded that it would be unnecessarily 
burdensome to require each such eligible clinician to be a party to the 
virtual group agreement. In addition, we agree that it is unnecessarily 
burdensome to require each solo practitioner or group that wishes to be 
part of a virtual group to have a separate agreement with every other 
solo practitioner or group that wishes to be part of the same virtual 
group. We do not believe the statute compels such a requirement; a 
single agreement among all solo practitioners and groups forming a 
virtual group is sufficient to implement the statutory requirement. 
Accordingly, we have revised the regulation text at Sec.  
414.1315(c)(3) to clarify that the parties to a formal written virtual 
group agreement must be only the groups and solo practitioners (as 
identified by name of party, TIN, and NPI) that compose the virtual 
group. We note that we are modifying our proposals for greater clarity.
    We recognize that our proposals regarding virtual group agreements 
as well as other virtual group matters used the term ``member of a 
virtual group'' inconsistently. In some places, we used the term to 
refer only to the components of the virtual group (that is, the solo 
practitioners and groups that can form a virtual group), while in other 
places we used the term to mean both the components of the virtual 
group and the eligible clinicians billing through a TIN that is a 
component of the virtual group. We believe that some of the perceived 
burden of the requirement for a virtual group agreement was due to the 
ambiguous use of this terminology. Wherever possible, we modified our 
proposals to ensure that they appropriately distinguishes between the 
components of a virtual group and the eligible clinicians billing 
through a TIN that is a component of a virtual group.
    Comment: One commenter expressed support for the proposed agreement 
provision that would require the parties to a virtual group agreement 
to be only solo practitioners and groups (not third parties), while 
another commenter did not support such provision and indicated that 
many small practices have joined IPAs to provide centralized support 
for quality improvement training, health technology support, reporting, 
and analytics needed for success under payment reform programs such as 
the Quality Payment Program. The commenter also indicated that IPAs 
could serve as the administrator of a virtual group by collecting and 
submitting data on behalf of the virtual group and requested that CMS 
eliminate the requirement for all members of a virtual group to execute 
a single joint agreement and expand the allowable

[[Page 53606]]

scope of the agreements by permitting IPAs to sign a virtual group 
agreement with each member of a virtual group.
    Response: For purposes of participation in MIPS as a virtual group, 
we note that eligible clinicians within a virtual group are 
collectively assessed and scored across each performance category based 
on applicable measures and activities that pertain to the performance 
of all TINs and NPIs within a virtual group. Each TIN and NPI within a 
virtual group has an integral role in improving quality of care and 
health outcomes, and increasing care coordination. As such, we believe 
it is appropriate prohibit third parties from becoming parties to a 
virtual group agreement. However, we note that virtual groups are not 
precluded from utilizing, or executing separate agreements with, third 
parties to provide support for virtual group implementation.
    Comment: To minimize the administrative burden, one commenter 
suggested that CMS not require all agreement requirements to be met in 
freestanding agreements. The commenter noted that the agreement could 
be an addendum to existing contracts to eliminate the need to draft an 
independent agreement, unless necessary.
    Response: We consider an ``existing'' contract to mean a contract 
that was established and executed prior to the formation of a virtual 
group. Depending on the parties to an existing contract, freestanding 
virtual group agreements may not be necessary. For example, if an 
existing contract was established between two or more TINs prior to the 
formation of a virtual group and such TINs formed a virtual group among 
themselves, the required provisions of a virtual group agreement could 
be included in the existing contract as an addendum as long as the 
parties to the existing contract include each TIN within the virtual 
group and all other requirements are satisfied prior to the applicable 
performance period. However, if the existing contract is with a third 
party intermediary or does not include each TIN within the virtual 
group, the virtual group agreement could not be effectuated as an 
addendum to the existing contract.
    We recognize that including virtual group agreement provisions as 
an addendum to an existing contract may reduce administrative burden 
and in certain circumstances such an addendum can be incorporated to an 
existing contract. However, we do believe it is critical that the 
inclusion of such provisions as an addendum does not limit or restrict 
the responsibility of each party to collectively meet the program 
requirements under MIPS. We reiterate that the statute requires formal 
written agreements to between each solo practitioner and group forming 
the virtual group. Individuals billing under the TIN of a party to a 
virtual group are collectively assessed and scored across each 
performance category based on applicable measures and activities that 
pertain to the performance of all TINs and NPIs within a virtual group. 
Each TIN and NPI within a virtual group has an integral role in 
improving quality of care and health outcomes, and increasing care 
coordination. As such, we believe it is appropriate to require 
agreements to only be between solo practitioners and groups and not 
include third parties. However, we note that virtual groups are not 
precluded from utilizing, or executing separate agreements with, third 
parties to provide support for virtual group implementation.
    Comment: One commenter requested that CMS clarify the parameters 
surrounding the proposed agreement provision that requires agreements 
to be executed on behalf of the TINs and the NPIs by individuals who 
are authorized to bind the TINs and the NPIs, and how CMS would 
evaluate the criterion in such provision when reviewing written 
agreements.
    Response: If a solo practitioner (or his or her professional 
corporation) is a party to a virtual group agreement, the solo 
practitioner could execute the agreement individually or on behalf of 
his or her professional corporation. We recognize that groups (TINs) 
have varying administrative and operational infrastructures. In 
general, one or more officers, agents, or other authorized individuals 
of a group would have the authority to legally bind the group. The 
parties to a virtual group agreement should ensure that the agreement 
is executed only by appropriately authorized individuals.
    Comment: One commenter expressed support for the proposed agreement 
provision that would require NPIs billing under a TIN in a virtual 
group to agree to participate in MIPS as a virtual group, and urged CMS 
to notify, by a means of direct communication, each NPI regarding his 
or her participation in MIPS as part of a virtual group prior to the 
performance period.
    Response: We appreciate the support from the commenter. We believe 
that it is critical for each eligible clinician in a virtual group to 
be aware of his or her participation in MIPS as part of a virtual 
group. Based on our experience under the Medicare Shared Savings 
Program, we found that NPIs continued to be unaware of their 
participation in a Medicare Shared Savings Program ACO regardless of 
the ACO's obligation to notify each NPI via direct communication. We 
considered directly notifying all NPIs regarding their participation in 
MIPS as part of a virtual group, but based on our experience under the 
Medicare Shared Savings Program, we do not believe that such action 
would be an effective way of ensuring that each NPI is aware of his or 
her TIN being part of a virtual group. We believe that communication 
within a TIN is imperative and the crux of ensuring that each NPI is 
aware of his or her participation in MIPS as part of a virtual group. 
As part of the virtual group election process, we will notify each 
virtual group representative regarding the official status of the 
virtual group. We will also require each TIN within a virtual group to 
notify all NPIs associated with the TIN of their participation in the 
MIPS as a virtual group.
    Comment: One commenter expressed support for one of the proposed 
agreement provisions that would set forth the NPI's rights and 
obligations in, and representation by, the virtual group. As part of 
the process for establishing an agreement, the commenter, as well as 
other commenters, requested that CMS allow virtual groups to discuss 
with all participants in the virtual group the ways in which the 
virtual group would meet the requirements for each performance 
category, the type of submission mechanism(s) the virtual group intends 
to utilize, the timelines for aggregating data across the TINs within 
the virtual group and for data submission, and the assessment and 
scoring of performance and application of the MIPS payment adjustment. 
Another commenter requested that the agreements include other elements 
such as requiring participation in improvement activities, use of EHR, 
and data sharing workflows, and suggested that CMS provide guidance on 
specific efficiencies and improvement goals that a virtual group could 
support and encourage virtual groups to create a plan for achieving 
those goals as a virtual group. A commenter suggested that the model 
agreement include provisions related to a mutual interest in quality 
performance, shared responsibility in decision making, a meaningful way 
to effectively use data to drive performance, and a mechanism to share 
best practices within the virtual group. Another commenter requested 
for CMS to develop a checklist for interested TINs to assist them in 
understanding the

[[Page 53607]]

requirements pertaining a virtual group agreement.
    Response: For the successful implementation of virtual groups, we 
believe that it is critical for everyone participating in a virtual 
group (including the individuals billing under the TIN of a group) to 
understand their rights and obligations in a virtual group. We believe 
that virtual groups should have the flexibility to identify additional 
requirements that would facilitate and guide a virtual group as it 
works to achieve its goals and meet program requirements. We note that 
the model agreement serves as a template that virtual groups could 
utilize in establishing a virtual group agreement, and could include 
other elements that would meet the needs of the virtual group to ensure 
that each TIN and NPI within a virtual group are collectively and 
collaboratively working together. We encourage the parties to a virtual 
group agreement to actively engage in discussions with eligible 
clinicians to develop a strategic plan, identify resources and needs, 
and establish processes, workflows, and other tools as they prepare for 
virtual group reporting. To support the efforts of solo practitioners 
and groups with 10 or fewer eligible clinicians in virtual group 
implementation, we intend to publish a virtual group toolkit that 
provides information pertaining to requirements and outlines the steps 
a virtual group would pursue during an the election process.
    Comment: One commenter requested that the agreement be a 1-year 
term and renewable thereafter.
    Response: We note that an agreement will need to be executed for at 
least one performance period. However, with virtual groups being 
required to be assessed and scored across all four performance 
categories, and the quality and cost performance categories having a 
calendar year performance period (at Sec.  414.1320), we clarify that a 
virtual group agreement would need to be executed for least a 1-year 
term. Virtual groups have the flexibility to establish a new agreement 
or renew the execution of an existing agreement for the preceding 
applicable performance period.
    Comment: One commenter requested that the virtual group agreements 
clearly specify the repercussions of an eligible clinician or group 
within a virtual group who fails to report as part of the virtual 
group.
    Response: We believe that the proposed provisions of a virtual 
group agreement provide a foundation that sets forth the 
responsibilities and obligations of each party for a performance 
period. Virtual groups have the flexibility to include other elements 
in an agreement. Each virtual group will be unique, and as a result, we 
encourage virtual groups to establish and execute an agreement that 
guides how a virtual group would meet its goals and objectives, and 
program requirements. Some virtual groups may elect to include a 
provision that outlines the implications of a solo practitioner or 
group failing to meet the elements of an agreement. We will also 
require such agreements to describe how the opportunity to receive 
payment adjustments will encourage each member of the virtual group 
(and each NPI under each TIN in the virtual group) to adhere to quality 
assurance and improvement.
    Comment: One commenter recommended that virtual group agreements 
contain similar elements used in agreements by the private sector, 
which would address factors pertaining to health IT and administrative 
and operationalization components such as: Requiring the establishment 
of a plan for integrating each virtual group component's health IT (for 
example, EHRs, patient registries, and practice management systems), 
including a timeline to work with health IT vendors on such 
integration, if applicable; requiring component of a virtual group to 
serve a common patient population and provide a list of hospitals and/
or facilities with which they have an affiliation and a list of 
counties in which they would be active; and determining how a virtual 
group would be staffed and governed by identifying staff allocations to 
organizational leadership, clinical leadership, practice consultants, 
and IT resources.
    Response: We recognize that different sectors may have established 
agreements with various elements to facilitate and assure attainment of 
program goals and objectives, which may serve as a useful tool to 
virtual groups. We encourage virtual groups to assess whether or not 
their agreement should include other elements in addition to our 
proposed agreement provisions. Virtual groups have the flexibility to 
identify other elements that would be critical to include in an 
agreement specific to their particular virtual group. We believe it is 
essential to continue to provide virtual groups with the flexibility to 
establish agreements that will most appropriately reflect the unique 
characteristics of a virtual group.
    Also, we note that different TINs, particularly small practices, 
may have access to different resources, which makes it difficult to 
identify specific requirements pertaining to the inclusion of 
administration and operationalization of health IT components in a 
virtual group agreement that would be universally applicable to any 
virtual group composition, while maintaining the flexibility and 
discretion afforded to virtual groups in establishing additional 
elements for their agreements that meet the needs of virtual groups. We 
recognize that each TIN within a virtual group will need to coordinate 
within the virtual group to address issues pertaining to 
interoperability, data collection, measure specifications, workflows, 
resources, and other related items, and believe that a virtual group is 
the most appropriate entity to determine how it will prepare, 
implement, and execute the functions of the virtual group to meet the 
requirements for each performance category. We believe that our 
proposed agreement elements provide a critical foundation for virtual 
group implementation, which establishes a clear responsibility and 
obligation of each NPI to the virtual group for the duration of an 
applicable performance period.
    Comment: Many commenters expressed concern regarding the timeframe 
virtual groups would have to make an election and establish agreements. 
The commenters indicated that the election period is very restrictive 
and does not provide interested solo practitioners and groups with 
sufficient time to meet and execute the required elements of an 
agreement and work through all of the necessary details in forming and 
implementing a virtual group. The commenters also noted that 
contractual agreements between NPIs and TINs often take several months, 
at least, to negotiate and finalize. A few commenters indicated that 
interested solo practitioners and groups would not have adequate time 
to make informed decisions regarding virtual group participation. The 
commenters noted that it would be helpful to have the virtual group 
agreement template available for review and comment in advance. One 
commenter indicated that the lack of virtual group requirements at this 
early stage of the Quality Payment Program causes a lack of clarity and 
stability for eligible clinicians and/or groups interested in forming 
virtual groups.
    Response: In order to provide support and reduce burden, we intend 
to make TA available, to the extent feasible and appropriate, to 
support clinicians who choose to come together as a virtual group. 
Clinicians can access the TA infrastructure and resources that they

[[Page 53608]]

may already be utilizing. In section II.C.4.e. of this final rule with 
comment period, we establish a two-stage virtual group election 
process, stage 1 of which is optional, for performance periods 
occurring in 2018 and 2019 (82 FR 30030 through 30032). Stage 1 
pertains to virtual group eligibility determinations, and stage 2 
pertains to virtual group formation. During stage 1, solo practitioners 
and groups have the option to contact their designated TA 
representative in order to obtain information pertaining to virtual 
groups and/or determine whether or not they are eligible, as it relates 
to the practice size requirement. Clinicians who do not elect to 
contact their designated TA representative would still have the option 
of contacting the Quality Payment Program Service Center to obtain 
information pertaining to virtual groups.
    We recognize that the election period, including the timeframe 
virtual groups would have to establish and implement the virtual group 
agreement, and the timeline for establishing virtual group policies in 
this final rule with comment period is short and imposes certain 
potential barriers for virtual group formation and limitations for the 
first year of virtual group implementation that we are not able to 
eliminate due to statutory constraints, such as the requirement for 
virtual groups to make an election made prior to an applicable 
performance period. In order to mitigate some of the challenges, we 
developed a model agreement to serve as a template that could be 
utilized by virtual groups as they prepare for the implementation of 
virtual groups and are finalizing a modification to the election period 
deadline by extending it to December 31, which can be accessed on the 
CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html. In this final rule with comment period, 
we are establishing virtual group policies for the 2018 and 2019 
performance periods. Solo practitioners and groups with 10 or fewer 
eligible clinicians that are not able to form virtual groups for the 
2018 performance period should have sufficient time to prepare and 
implement requirements applicable to virtual groups for the 2019 
performance period.
    Comment: A majority of commenters indicated that virtual group 
formation involves preparing health IT systems, training staff to be 
ready for implementation, sharing and aggregating data, and 
coordinating workflows. The commenters expressed concern that while 
such steps are necessary to ensure the success of virtual groups, such 
steps could raise issues regarding compliance with certain fraud and 
abuse laws, particularly the physician self-referral law (section 1877 
of the Act) and the anti-kickback statute (section 1128B(b) of the 
Act). The commenters requested that CMS assess the potential risks 
virtual groups may have under the physician self-referral law and 
whether or not a regulatory exception would be necessary to 
successfully implement and maximize the advantages of the virtual group 
option. One commenter noted that parties to a virtual group agreement 
may want to enter into financial arrangements with each other to 
maximize the benefit of the virtual group (for example, pay for one 
party to organize and submit all measures on behalf of all the virtual 
group parties) and that such an arrangement may result in some eligible 
clinicians being unable to refer patients to other participants in the 
virtual group without running afoul of the physician self-referral law, 
unless CMS established an exception for virtual groups. A few 
commenters requested that the Secretary exercise prosecutorial 
discretion by not enforcing the anti-kickback statute and the physician 
self-referral law for activities involving the development and 
operation of a virtual group.
    Many commenters expressed concerns regarding the lack of 
information and clarity pertaining to the interaction between virtual 
groups and the physician self-referral law, anti-kickback statute, and 
antitrust law. The commenters requested that CMS clarify the program 
integrity obligations of virtual groups, issue safe harbors, and 
publish guidance outlining how the physician self-referral law, anti-
kickback statute, and antitrust law apply to virtual groups. The 
commenters asserted that this was needed in order for solo 
practitioners and groups to maintain safeguards against fraud and abuse 
while soliciting partners to form a virtual group and working toward 
common MIPS goals.
    Response: Nothing in this final rule with comment period changes 
the application of the physician self-referral law, anti-kickback 
statute, or anti-trust laws. We note that a ``group practice'' as 
defined for purposes of the physician self-referral law is separate and 
distinct from a ``virtual group'' as defined in this final rule. A 
virtual group may, but is not required, to include a ``group practice'' 
as defined for purposes of the physician self-referral law. Whether an 
entity that is assigned a TIN and is included in a virtual group should 
be a ``group practice'' (as defined for purposes of the physician self-
referral law) is a separate legal issue that is not governed by this 
final rule with comment period. We recognize that a virtual group may 
include multiple clinician practices and that the clinicians in one 
practice may refer patients for services that will be furnished by 
other practices in the virtual group. However, we believe that the 
virtual group arrangement can be structured in a manner that both 
complies with an existing physician self-referral law exception and 
does not violate the anti-kickback statute. We note that the issuance 
of guidance, exceptions, or safe harbors regarding the physician self-
referral law or the anti-kickback statute is beyond the scope of this 
rulemaking, and MACRA does not authorize the Secretary to waive any 
fraud and abuse laws for MIPS. Finally, HHS is not authorized to 
interpret or provide guidance regarding the anti-trust laws.
    Comment: Several commenters supported the development of a model 
agreement. One commenter indicated that the model agreement lacked the 
details necessary to enable virtual groups to cover all required 
criteria and urged CMS to supply a template that is inclusive of needed 
detail and instructions.
    Response: We appreciate the support from commenters. In regard to 
the model agreement, we established such a template in order to reduce 
the burden of virtual groups having to develop an agreement. On August 
18, 2017, we published a 30-day Federal Register notice (82 FR 39440) 
announcing our formal submission of the ICR for the virtual group 
election process to OMB, which included a model formal written 
agreement, and informing the public on its additional opportunity to 
review the information collection request and submit comments by 
September 18, 2017. OMB approved the ICR on September 27, 2017 (OMB 
control number 0938-1343). The utilization of our model agreement is 
not required, but serves as a tool that can be utilized by virtual 
groups. Each prospective party to a virtual group agreement should 
consult their own legal and other appropriate counsel as necessary in 
establishing the agreement. We note that the received comments 
pertaining to the content of the model agreement are out of scope for 
this final rule with comment period.
    Final Action: After consideration of public comments received, we 
are finalizing with modification our proposal at Sec.  414.1315(c)(3) 
regarding virtual group agreements. This final rule

[[Page 53609]]

with comment period requires a formal written agreement between each 
solo practitioner and group that composes a virtual group; the revised 
regulation text makes it clear the formal written virtual group 
agreement must identify, but need not include as parties to the 
agreement, all eligible clinicians who bill under the TINs that are 
components of the virtual group. The requirement to execute a formal 
written virtual group agreement ensures that requirements and 
expectations of participation in MIPS are clearly articulated, 
understood, and agreed upon. We are finalizing our proposal that a 
virtual group agreement must be executed on behalf of a party to the 
agreement by an individual who is authorized to bind the party. For 
greater clarity, we are finalizing with modification our proposals at 
Sec.  414.1315(c)(3) that a formal written agreement between each 
member of a virtual group must include the following elements:
     Identifies the parties to the agreement by name of party, 
TIN, and NPI, and includes as parties to the agreement only the groups 
and solo practitioners that compose the virtual group (at Sec.  
414.1315(c)(3)(i)).
     Is executed on behalf of each party by an individual who 
is authorized to bind the party (at Sec.  414.1315(c)(3)(ii)).
     Expressly requires each member of the virtual group (and 
each NPI under each TIN in the virtual group) to participate in MIPS as 
a virtual group and comply with the requirements of the MIPS and all 
other applicable laws and regulations (including, but not limited to, 
federal criminal law, False Claims Act, anti-kickback statute, civil 
monetary penalties law, the Health Insurance Portability and 
Accountability Act of 1996, and physician self-referral law) (at Sec.  
414.1315(c)(3)(iii)).
     Identifies each NPI under each TIN in the virtual group 
and requires each TIN within a virtual group to notify all NPIs 
associated with the TIN of their participation in the MIPS as a virtual 
group (at Sec.  414.1315(c)(3)(iv)).
     Sets forth the NPI's rights and obligations in, and 
representation by, the virtual group, including without limitation, the 
reporting requirements and how participation in MIPS as a virtual group 
affects the ability of the NPI to participate in the MIPS outside of 
the virtual group (at Sec.  414.1315(c)(3)(v)).
     Describes how the opportunity to receive payment 
adjustments will encourage each member of the virtual group (and each 
NPI under each TIN in the virtual group) to adhere to quality assurance 
and improvement (at Sec.  414.1315(c)(3)(vi)).
     Requires each party to the agreement to update its 
Medicare enrollment information, including the addition and deletion of 
NPIs billing through its TIN, on a timely basis in accordance with 
Medicare program requirements and to notify the virtual group of any 
such changes within 30 days after the change (at Sec.  
414.1315(c)(3)(vii)).
     Is for a term of at least one performance period as 
specified in the formal written agreement (at Sec.  
414.1315(c)(3)(viii)).
     Requires completion of a close-out process upon 
termination or expiration of the agreement that requires each party to 
the virtual group agreement to furnish, in accordance with applicable 
privacy and security laws, all data necessary in order for the virtual 
group to aggregate its data across the virtual group (at Sec.  
414.1315(c)(3)(ix)).
    During the election process and submission of a virtual group 
election, a designated virtual group representative will be required to 
confirm through acknowledgement that an agreement is in place between 
all solo practitioners and groups that compose the virtual group. An 
agreement will be executed for at least one performance period. If a 
NPI joins or leaves a TIN, or a change is made to a TIN that impacts 
the agreement itself, such as a legal business name change, during the 
applicable performance period, a virtual group will be required to 
update the agreement to reflect such changes and submit changes to CMS 
via the Quality Payment Program Service Center.
g. Virtual Group Reporting Requirements
    As discussed in section II.C.4.d. of this final rule with comment 
period, we believe virtual groups should generally be treated under the 
MIPS as groups. Therefore, for MIPS eligible clinicians participating 
at the virtual group level, we proposed at Sec.  414.1315(d) the 
following requirements (82 FR 30033):
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level would have their performance assessed as a virtual 
group (at Sec.  414.1315(d)(1)).
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level would need to meet the definition of a virtual 
group at all times during the performance period for the MIPS payment 
year (at Sec.  414.1315(d)(2)).
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level must aggregate their performance data across 
multiple TINs in order for their performance to be assessed as a 
virtual group (at Sec.  414.1315(d)(3)).
     MIPS eligible clinicians that elect to participate in MIPS 
at the virtual group level would have their performance assessed at the 
virtual group level across all four MIPS performance categories (at 
Sec.  414.1315(d)(4)).
     Virtual groups would need to adhere to an election process 
established and required by CMS (at Sec.  414.1315(d)(5)).
    The following is a summary of the public comments received 
regarding our proposed virtual group reporting requirements.
    Comment: Many commenters generally supported our proposed reporting 
requirements for virtual groups.
    Response: We appreciate the support from the commenters.
    Comment: One commenter expressed support of our proposed virtual 
group reporting requirements and indicated that a majority of 
practicing vascular surgeons are part of private practices, including 
groups of 10 or fewer eligible clinicians, and would benefit from 
participating in MIPS as part of a virtual group. The commenter noted 
that the implementation of virtual groups would ease burdens on small 
practices and eligible clinicians by allowing them to report data 
together for each performance category, and be assessed and scored as a 
virtual group. Another commenter supported our proposal that allows 
small practices to aggregate their data at the virtual group level, 
which would allow them to have a larger denominator to spread risk and 
mitigate the impact of adverse outlier situations.
    Response: We appreciate the support from the comment regarding our 
proposed virtual group reporting requirements.
    Comment: One commenter indicated that the reporting of performance 
data for all NPIs under a TIN participating in a virtual group, 
particularly non-MIPS eligible clinicians who are excluded from MIPS 
participation, would be a regulatory burden to virtual groups.
    Response: We do not believe that requiring virtual groups to report 
on data for all NPIs under a TIN participating in a virtual group would 
be burdensome to virtual groups. Based on previous feedback from 
stakeholders regarding group reporting under PQRS, we believe that it 
would be more burdensome for virtual groups to

[[Page 53610]]

determine which clinicians are MIPS eligible versus not MIPS eligible 
and remove performance data for non-MIPS eligible clinicians when 
reporting as a virtual group. While entire TINs participate in a 
virtual group, including each NPI under a TIN, and are assessed and 
scored collectively as a virtual group, we note that only NPIs that 
meet the definition of a MIPS eligible clinician would be subject to a 
MIPS payment adjustment.
    Comment: A majority of commenters did not support our proposal to 
require all eligible clinicians who are part of a TIN participating in 
MIPS at the virtual group level to aggregate their performance data 
across multiple TINs in order for their performance to be assessed and 
scored as a virtual group. The commenters expressed concerns that it 
would be burdensome for rural and small practices and prohibitive for 
virtual groups to perform data aggregation and requested that CMS 
aggregate data for virtual groups. The commenters indicated that the 
requirement for virtual groups to aggregate data across the virtual 
group could be a potential barrier for virtual group participation and 
would be unlikely to occur without error. One commenter requested that 
CMS further define data aggregation and clarify whether or not 
individual reports from each NPI within a virtual group could simply be 
added together for all NPIs in the virtual group or if each NPI's data 
could be pulled from each TIN's QRDA file.
    Response: We appreciate the feedback from the commenters and 
recognize that data aggregation across multiple TINs within a virtual 
group may pose varying challenges. At this juncture, it is not 
technically feasible for us to aggregate the data for virtual groups, 
but will consider such option in future years. In order to support the 
implementation of virtual groups as a participation option under MIPS, 
we intend to issue subregulatory guidance pertaining to data 
aggregation for virtual groups.
    Comment: A few commenters recommended that for the first year of 
virtual group implementation, CMS hold virtual groups and registries 
that support virtual groups harmless from penalties if they encounter 
technical challenges related to data aggregation. The commenters noted 
that the potential penalty for technical challenges in data aggregation 
is a severe 5 percent for TINs that are already operating on small 
margins and expressed concerns that registries supporting virtual group 
reporting would be opening themselves to potential disqualification for 
the aforementioned challenges in data aggregation.
    Response: We appreciate the feedback from commenters and note that 
statute requires virtual groups to be assessed and scored, and subject 
to a MIPS payment adjustment as a result of TINs participating in a 
virtual group under MIPS. The statute does not authorize us to 
establish additional exclusions that are not otherwise identified in 
statute. If a virtual group encounters technical challenges regarding 
data aggregation and are not able to report on measures and activities 
via QCDRs, qualified registries, or EHRs, virtual groups would have the 
option of reporting via the CMS Web Interface (for virtual groups of 25 
or more eligible clinicians), a CMS-approved survey vendor for the 
CAHPS for MIPS survey, and administrative claims (if applicable) for 
the quality and cost performance categories, and via attestation for 
the improvement activities and advancing care information performance 
categories. The administrative claims submission mechanism does not 
require virtual groups to submit data for purposes of the quality and 
cost performance categories but the calculation of performance data is 
conducted by CMS.
    We note that the measure reporting requirements applicable to 
groups are also generally applicable to virtual groups. However, we 
note that the requirements for calculating measures and activities when 
reporting via QCDRs, qualified registries, EHRs, and attestation differ 
in their application to virtual groups. Specifically, these 
requirements apply cumulatively across all TINs in a virtual group. 
Thus, virtual groups will aggregate data for each NPI under each TIN 
within the virtual group by adding together the numerators and 
denominators and then cumulatively collate to report one measure ratio 
at the virtual group level. Moreover, if each MIPS eligible clinician 
within a virtual group faces a significant hardship or has EHR 
technology that has been decertified, the virtual group can apply for 
an exception to have its advancing care information performance 
category reweighted. If such exception application is approved, the 
virtual group's advancing care information performance category is 
reweighted to zero percent and applied to the quality performance 
category increasing the quality performance weight from 50 percent to 
75 percent.
    Additionally, the data submission criteria applicable to groups are 
also generally applicable to virtual groups. However, we note that data 
completeness and sampling requirements for the CMS Web Interface and 
CAHPS for MIPS survey differ in their application to virtual groups. 
Specifically, data completeness for virtual groups applies cumulatively 
across all TINs in a virtual group. Thus, we note that there may be a 
case when a virtual group has one TIN that falls below the 60 percent 
data completeness threshold, which is an acceptable case as long as the 
virtual group cumulatively exceeds such threshold. In regard to the CMS 
Web Interface and CAHPS for MIPS survey, sampling requirements pertain 
to Medicare Part B patients with respect to all TINs in a virtual 
group, where the sampling methodology would be conducted for each TIN 
within the virtual group and then cumulatively aggregated across the 
virtual group. A virtual group would need to meet the beneficiary 
sampling threshold cumulatively as a virtual group.
    Comment: A few commenters urged CMS to set clear expectations as to 
how virtual groups should submit data across performance categories and 
from multiple systems while ensuring their information is aggregated 
and reported correctly to maximize the virtual group's final score and 
requested that CMS provide clarity regarding virtual group reporting. 
One commenter indicated that virtual group reporting can be completed 
through QCDRs, in which multiple eligible clinicians in a virtual group 
could report to one place on the quality of care furnished to their 
respective patients. The commenter noted that the commitments from CMS 
and ONC regarding interoperability and electronic data sharing would 
continue to further the feasibility of virtual group reporting through 
EHRs in the future. However, a few commenters requested clarification 
regarding how data can and should be submitted for virtual groups, and 
whether or not QCDRs and other clinical outcomes data registries would 
be able to assist virtual groups by sharing in the responsibility for 
aggregating data. The commenters noted that the aggregation of data 
across various TINs and health IT systems may be logistically difficult 
and complex, as groups and health IT systems have different ways of 
collecting and storing data and stated that data aggregation across 
various systems for measures and activities under each performance 
category may not be possible if qualified registries do not have the 
option to assist virtual groups.
    Response: We appreciate the feedback from commenters and recognize 
that commenters seek clarification regarding submission requirements 
for third party intermediaries such as QCDRs, qualified registries, and 
EHRs. We note that third

[[Page 53611]]

party intermediaries would need to meet the same requirements 
established at Sec.  414.1400 and form and manner per submission 
mechanism when submitting data on behalf of virtual groups. We intend 
to issue subregulatory guidance for virtual groups and third party 
intermediaries pertaining to data aggregation and the collection and 
submission of data.
    Comment: One commenter requested clarification regarding the 
submission of data for virtual groups via EHRs. The commenter indicated 
that while groups may already be familiar with the reporting of quality 
measures via EHRs, the addition of the improvement activities and 
advancing care information performance categories adds a new level of 
complexity. Also, the commenter requested clarification regarding 
whether or not CMS has an established mechanism that would accept 
multiple QRDA III submissions for a single virtual group pertaining to 
the improvement activities and advancing care information performance 
categories. The commenter indicated that standards do not exist to 
combine files pertaining to the improvement activities and advancing 
care information performance categories from disparate vendors and 
requested clarification regarding whether or not combined files would 
be needed for virtual groups and for CMS to issue guidance to vendors 
at least 18 months in advance regarding development and implementation.
    Response: We appreciate the feedback from the commenter and note 
that we intend to issue additional subregulatory guidance for third 
party intermediaries pertaining to the collection and submission of 
data for all performance categories. In regard to the submission of 
multiple QRDA III files, our system is not built to allow for the 
submission of multiple QRDA III files. Groups and virtual groups are 
required to submit one QRDA III file for each performance category. 
Given that virtual groups are required to aggregate their data at the 
virtual level and submit one file of data per performance category, 
there may be circumstances that would require a virtual group to 
combine their files in order to meet the submission requirements. 
However, it should be noted that all other measures and activities 
requirements would also need to be met in order for virtual groups to 
meeting reporting and submission requirements.
    Comment: One commenter requested that CMS allow QCDRs and other 
clinical outcomes data registries to support virtual groups in 
aggregating measures and activities for reporting.
    Response: We note that virtual groups are not precluded from 
utilizing third party intermediaries such as QCDRs and qualified 
registries to support virtual groups in meeting virtual group reporting 
requirements. We intend to issue subregulatory guidance for virtual 
groups and third party intermediaries pertaining to data aggregation 
and the collection and submission of data.
    Comment: A few commenters expressed concern that the submission 
mechanisms available to virtual groups involve multiple layers of legal 
and operational complexity. The commenters indicated that certain 
registries have internal data governance standards, including patient 
safety organization requirements, that they must follow when 
contracting with single TIN participants, such that legal agreements 
made between solo practitioners and small groups within a virtual group 
may complicate the registries' ability to comply with those 
requirements. The commenters recommended that CMS provide guidance to 
registries on how to handle data sharing among virtual groups with 
respect to patient safety organization requirements. One commenter 
expressed concern regarding how registries would be able to meet 
virtual group requirements to report a sufficient number of measures 
given that some registries may have made a variety of measures 
available for individual eligible clinicians to report, but may need to 
increase the available measures to report in order to support virtual 
group reporting. The commenter requested that CMS provide guidance 
regarding the expectations for registries supporting virtual group 
reporting, particularly when considering the role of specialty 
registries and the quality performance category.
    Response: We recognize that certain registries may have internal 
governance standards complicating how they would support virtual 
groups, but note that by definition, a virtual group is a combination 
of TINs. We appreciate the feedback from commenters and note that we 
intend to issue additional subregulatory guidance for third party 
intermediaries such as qualified registries.
    Comment: One commenter expressed concern regarding how quality data 
would be collected, aggregated and displayed for solo practitioners and 
groups composing the virtual group. The commenter requested 
clarification regarding whether or not solo practitioners and groups 
composing the virtual group would be allowed to view the quality data 
of other solo practitioners and groups in the virtual group. Also, the 
commenter indicated that it is not clear what responsibility a 
qualified registry would have, if any, to verify if a virtual group 
reporting through a registry has all the appropriate legal agreements 
in place prior to their participation in the registry.
    Response: We appreciate the commenter expressing such concern and 
note that we intend to issue subregulatory guidance for virtual groups 
and third party intermediaries pertaining to data aggregation and the 
collection and submission of data. We note that the measure reporting 
requirements applicable to groups are also generally applicable to 
virtual groups. However, we note that the requirements for calculating 
measures and activities when reporting via QCDRs, qualified registries, 
EHRs, and attestation differ in their application to virtual groups. 
Specifically, these requirements apply cumulatively across all TINs in 
a virtual group. Thus, virtual groups will aggregate data for each NPI 
under each TIN within the virtual group by adding together the 
numerators and denominators and then cumulatively collate to report one 
measure ratio at the virtual group level. Moreover, if each MIPS 
eligible clinician within a virtual group faces a significant hardship 
or has EHR technology that has been decertified, the virtual group can 
apply for an exception to have its advancing care information 
performance category reweighted. If such exception application is 
approved, the virtual group's advancing care information performance 
category is reweighted to zero percent and applied to the quality 
performance category increasing the quality performance weight from 50 
percent to 75 percent.
    Additionally, the data submission criteria applicable to groups are 
also generally applicable to virtual groups. However, we note that data 
completeness and sampling requirements for the CMS Web Interface and 
CAHPS for MIPS survey differ in their application to virtual groups. 
Specifically, data completeness for virtual groups applies cumulatively 
across all TINs in a virtual group. Thus, we note that there may be a 
case when a virtual group has one TIN that falls below the 60 percent 
data completeness threshold, which is an acceptable case as long as the 
virtual group cumulatively exceeds such threshold. In regard to the CMS 
Web Interface and CAHPS for MIPS survey, sampling requirements pertain 
to Medicare Part B patients with respect to all TINs in a virtual 
group, where the sampling methodology would be conducted for

[[Page 53612]]

each TIN within the virtual group and then cumulatively aggregated 
across the virtual group. A virtual group would need to meet the 
beneficiary sampling threshold cumulatively as a virtual group. In 
regard to the comment requesting clarification on whether or not solo 
practitioners and groups composing a virtual group would be allowed to 
view quality data of other solo practitioners and groups in the virtual 
group, we note that virtual groups have the flexibility to determine 
if, how, and when solo practitioners and groups in the virtual group 
would be able to view quality data and/or data pertaining to the other 
three performance categories, in which such permissibility could be 
established as a provision under the virtual group agreement. Moreover, 
the establishment and execution of a virtual group agreement is the 
responsibility of the parties electing to participate in MIPS as part 
of a virtual group. Health IT vendors or third party intermediaries are 
not required to verify that each virtual group has established and 
executed a prior virtual group agreement.
    Comment: One commenter indicated that there would be added 
technical challenges for a virtual group representative when submitting 
on behalf of their virtual group given that he or she may face errors 
or warnings during submission and, due to the possibility that 
individual files could come from various EHR vendors, that 
representative would not have authority or the ability to work directly 
with another TIN's vendor.
    Response: We note that virtual groups have the flexibility to 
determine how they would complete reporting under MIPS. We believe that 
virtual groups would need to address operational elements to ensure 
that it would meet the reporting requirements for each performance 
category. Virtual groups are able to utilize the same multiple 
submission mechanisms that are available to groups. For the 2018 
performance period, groups and virtual groups can utilize multiple 
submission mechanism, but only use one submission mechanism per 
performance category. Starting with the 2019 performance period, groups 
and virtual groups will be able to utilize multiple submission 
mechanisms for each performance category.
    Comment: One commenter recommended that the virtual group 
infrastructure be defined and tested prior to implementation and noted 
that virtual group implementation does not appear to be ready for CY 
2018. Another commenter suggested that the virtual group reporting 
option have a transition year for the CY 2018 and CY 2019 performance 
periods in order for solo practitioners and groups to become familiar 
with implementing the virtual group reporting option as well as the 
election process and executing agreements. The commenter requested that 
virtual groups have the ``pick your pace'' options that were 
established for the CY 2017 performance period for the CY 2018 
performance period in order to test the virtual group option, whereby 
the virtual group would only need to report one quality measure or one 
improvement activity to avoid a negative MIPS payment adjustment.
    Response: We note that it is not permissible for virtual groups to 
meet the requirements established for the 2017 performance period given 
that such requirements are not applicable to the 2018 performance 
period. Moreover, the ``pick your pace'' options were based on the 
lower performance threshold established for the CY 2017 performance 
period. As discussed in section II.C.8.c. of this final rule with 
comment period, we are finalizing a higher performance threshold for 
the CY 2018 performance period, and the statute requires the 
establishment of one performance threshold for a performance period, 
which is the same for all MIPS eligible clinicians regardless of how or 
when they participate in MIPS. Year 2 requirements for virtual groups 
are defined throughout this final rule with comment period.
    Comment: One commenter requested that CMS require virtual groups to 
report a plan prior to the start of the performance period regarding 
how members of the virtual group (solo practitioners and groups) would 
share data internally, including how they would identify the measures 
that the virtual group would report, and share NPI-level performance 
data on those measures with each other during the performance period to 
facilitate performance improvement.
    Response: We appreciate the commenter recommending requirements for 
virtual groups, but disagree with the recommendation that would require 
virtual groups to submit a report to us prior to the start of the 
performance period outlining how the virtual group would share data 
internally, how the virtual group would identify the measures and 
activities to report, and share NPI-level performance data on those 
measures with each other during the performance period to facilitate 
performance improvement. We believe that the submission of such report 
prior to the start of the performance period would increase 
administrative burden for virtual groups. However, we encourage virtual 
groups to actively engage in discussions with its members to develop a 
strategic plan, select measures and activities to report, identify 
resources and needs, and establish processes, workflows, and other 
tools as they prepare for virtual group reporting. Virtual groups have 
the flexibility to identify other elements, in addition to our proposed 
agreement provisions, that would be critical to include in an agreement 
specific to their particular virtual group. We believe that virtual 
groups should have the flexibility to identify additional requirements 
that would facilitate and guide a virtual group as it works to achieve 
its goals and meet program requirements.
    Comment: One commenter recommended that CMS require all eligible 
clinicians within a virtual group to report on the same measure set. 
The commenter indicated that unifying measures would allow CMS to 
aggregate numerators and denominators more easily when calculating 
performance against measures.
    Response: For virtual groups that report via the CMS Web Interface, 
they would report on all measures within the CMS Web Interface. For 
virtual groups that report via other submission mechanisms, they would 
report on the same 6 measures for the quality performance category. We 
encourage virtual groups to assess the types of measures and measure 
sets to report to ensure that they would meet the reporting 
requirements for the applicable performance categories.
    Comment: One commenter recommended that CMS develop a web-based 
portal that would streamline reporting requirements for virtual groups. 
For example, CMS could model, to the extent possible and appropriate, a 
virtual group web-based portal on the CMS Web Interface. The 
availability of a web-based portal would relieve a substantial burden 
for solo practitioners and small groups who do not have the same level 
of resources as larger groups to purchase and maintain the 
infrastructure necessary for MIPS reporting. Moreover, the commenter 
indicated that a single reporting portal would ease data collection 
burden on CMS, enabling the Agency to collect and pull data from a 
single source under a single submission mechanism rather than engaging 
in a more cumbersome process that could require multiple data 
collection and submission mechanisms.
    Response: We have developed a web-based portal submission system 
that streamlines and simplifies the

[[Page 53613]]

submission of data at the individual, group, and virtual group level, 
including the utilization of multiple submission mechanisms (one 
submission mechanism per performance category), for each performance 
category. We will be issuing guidance at qpp.cms.gov pertaining to the 
utilization and functionality of such portal.
    Comment: Several commenters requested that CMS clarify whether or 
not data should be de-duplicated for virtual group reporting. The 
commenters indicated that TINs already have an issue of not being able 
to de-duplicate patient data across different health IT systems/
multiple EHRs. The commenters indicated that virtual groups need clear 
guidelines regarding how to achieve accurate reporting and suggested 
that CMS may want to consider delaying implementation of the virtual 
group reporting option until all related logistics issues and solutions 
are identified.
    Response: We interpret the commenter's reference to ``de-
duplicate'' to mean the identification of unique patients across a 
virtual group. We recognize that it may be difficult to identify unique 
patients across a virtual group for the purposes of aggregating 
performance on the advancing care information measures, particularly 
when a virtual group is using multiple CEHRT systems. For 2018, virtual 
groups may be using systems which are certified to different CEHRT 
editions further adding to this challenge. We consider ``unique 
patients'' to be individual patients treated by a TIN within a virtual 
group who would typically be counted as one patient in the denominator 
of an advancing care information measure. This patient may see multiple 
MIPS eligible clinicians within a TIN that is part of a virtual group, 
or may see MIPS eligible clinicians at multiple practice sites of a TIN 
that is part of a virtual group. When aggregating performance on 
advancing care information measures for virtual group level reporting, 
we do not require that a virtual group determine that a patient seen by 
one MIPS eligible clinician (or at one location in the case of TINs 
working with multiple CEHRT systems) is not also seen by another MIPS 
eligible clinician in the TIN that is part of the virtual group or 
captured in a different CEHRT system.
    In regard to the suggestion provided by the commenter regarding the 
delay of the implementation of virtual groups, we are not able to 
further postpone the implementation of virtual groups. We recognize 
that there are various elements and factors that virtual groups would 
need to address prior to the execution of virtual groups. Also, we 
recognize that certain solo practitioners and groups may not be ready 
to form virtual groups for the 2018 performance period.
    Comment: One commenter expressed concern regarding how a health IT 
vendor would support a virtual group regardless of submission 
mechanism, CEHRT, registry, and/or billing claims. The commenter 
indicated that having multiple health IT vendors and products to 
support within a single virtual group would complicate the ability to 
aggregate data for a final score, affect the productivity of the health 
IT vendor in its effort to support the virtual groups, and increase 
coding and billing errors.
    Response: We note that virtual groups may elect to utilize health 
IT vendors and/or third party intermediaries for the collection and 
submission of data on behalf of virtual groups. As discussed in section 
II.C.6.a.(1) of this final rule with comment period, the submission 
mechanisms available to groups under each performance category will 
also be available to virtual groups. Similarly, virtual groups will 
also have the same option as groups to utilize multiple submission 
mechanisms, but only one submission mechanism per performance category 
for the 2018 performance period. However, starting with the 2019 
performance period, groups and virtual groups will be able to utilize 
multiple submission mechanisms for each performance category. We 
believe that our policies pertaining to the availability and 
utilization of multiple submission mechanisms increases flexibility and 
reduces burden. However, we recognize that data aggregation across at 
the virtual group level may pose varying challenges.
    We note that the measure reporting requirements applicable to 
groups are also generally applicable to virtual groups. However, we 
note that the requirements for calculating measures and activities when 
reporting via QCDRs, qualified registries, EHRs, and attestation differ 
in their application to virtual groups. Specifically, these 
requirements apply cumulatively across all TINs in a virtual group. 
Thus, virtual groups will aggregate data for each NPI under each TIN 
within the virtual group by adding together the numerators and 
denominators and then cumulatively collate to report one measure ratio 
at the virtual group level. Moreover, if each MIPS eligible clinician 
within a virtual group faces a significant hardship or has EHR 
technology that has been decertified, the virtual group can apply for 
an exception to have its advancing care information performance 
category reweighted. If such exception application is approved, the 
virtual group's advancing care information performance category is 
reweighted to zero percent and applied to the quality performance 
category increasing the quality performance weight from 50 percent to 
75 percent.
    Additionally, the data submission criteria applicable to groups are 
also generally applicable to virtual groups. However, we note that data 
completeness and sampling requirements for the CMS Web Interface and 
CAHPS for MIPS survey differ in their application to virtual groups. 
Specifically, data completeness for virtual groups applies cumulatively 
across all TINs in a virtual group. Thus, we note that there may be a 
case when a virtual group has one TIN that falls below the 60 percent 
data completeness threshold, which is an acceptable case as long as the 
virtual group cumulatively exceeds such threshold. In regard to the CMS 
Web Interface and CAHPS for MIPS survey, sampling requirements pertain 
to Medicare Part B patients with respect to all TINs in a virtual 
group, where the sampling methodology would be conducted for each TIN 
within the virtual group and then cumulatively aggregated across the 
virtual group. A virtual group would need to meet the beneficiary 
sampling threshold cumulatively as a virtual group.
    Final Action: After consideration of the public comments received, 
we are finalizing the following virtual group reporting requirements:
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level will have their performance assessed as a virtual 
group at Sec.  414.1315(d)(1).
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level will need to meet the definition of a virtual group 
at all times during the performance period for the MIPS payment year 
(at Sec.  414.1315(d)(2)).
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level must aggregate their performance data across 
multiple TINs in order for their performance to be assessed as a 
virtual group (at Sec.  414.1315(d)(3)).
     MIPS eligible clinicians that elect to participate in MIPS 
at the virtual group level will have their performance assessed at the 
virtual group level across all four MIPS performance categories (at 
Sec.  414.1315(d)(4)).

[[Page 53614]]

     Virtual groups will need to adhere to an election process 
established and required by CMS (at Sec.  414.1315(d)(5)).
h. Virtual Group Assessment and Scoring
    As noted in section II.C.4.a. of this final rule with comment 
period, section 1848(q)(5)(I)(i) of the Act provides that MIPS eligible 
clinicians electing to be a virtual group must: (1) Have their 
performance assessed for the quality and cost performance categories in 
a manner that applies the combined performance of all the MIPS eligible 
clinicians in the virtual group to each MIPS eligible clinician in the 
virtual group for the applicable performance period; and (2) be scored 
for the quality and cost performance categories based on such 
assessment for the applicable performance period. We believe it is 
critical for virtual groups to be assessed and scored at the virtual 
group level for all performance categories, as it eliminates the burden 
of virtual group components having to report as a virtual group and 
separately outside of a virtual group. Additionally, we believe that 
the assessment and scoring at the virtual group level provides for a 
comprehensive measurement of performance, shared responsibility, and an 
opportunity to effectively and efficiently coordinate resources to also 
achieve performance under the improvement activities and the advancing 
care information performance categories. Therefore, we proposed at 
Sec.  414.1315(d)(4) that virtual groups would be assessed and scored 
across all four MIPS performance categories at the virtual group level 
for a performance period for a year (82 FR 30033 through 30034).
    In the CY 2017 Quality Payment Program final rule (81 FR 77319 
through 77329), we established the MIPS final score methodology at 
Sec.  414.1380, which would apply to virtual groups. We refer readers 
to sections II.C.4.h. and II.C.6.g. of this final rule with comment 
period for scoring policies that would apply to virtual groups.
    As noted in section II.C.4.g. of this final rule with comment 
period, we proposed to allow solo practitioners and groups with 10 or 
fewer eligible clinicians that have elected to be part of a virtual 
group to have their performance measured and aggregated at the virtual 
group level across all four performance categories; however, we would 
apply payment adjustments at the individual TIN/NPI level. Each TIN/NPI 
would receive a final score based on the virtual group performance, but 
the payment adjustment would still be applied at the TIN/NPI level. We 
would assign the virtual group score to all TIN/NPIs billing under a 
TIN in the virtual group during the performance period.
    During the performance period, we recognized that NPIs in a TIN 
that has joined a virtual group may also be participants in an APM. The 
TIN, as part of the virtual group, would be required to submit 
performance data for all eligible clinicians associated with the TIN, 
including those participating in APMs, to ensure that all eligible 
clinicians associated with the TIN are being measured under MIPS.
    APMs seek to deliver better care at lower cost and to test new ways 
of paying for care and measuring and assessing performance. In the CY 
2017 Quality Payment Program final rule, we established policies to the 
address concerns we have expressed in regard to the application of 
certain MIPS policies to MIPS eligible clinicians in MIPS APMs (81 FR 
77246 through 77269). In the CY 2018 Quality Payment Program proposed 
rule, we reiterated those concerns and proposed additional policies for 
the APM scoring standard (82 FR 30080 through 30091). We believe it is 
important to consistently apply the APM scoring standard under MIPS for 
eligible clinicians participating in MIPS APMs in order to avoid 
potential misalignments between the evaluation of performance under the 
terms of the MIPS APM and evaluation of performance on measures and 
activities under MIPS, and to preserve the integrity of the initiatives 
we are testing. Therefore, we believe it is necessary to waive the 
requirement to only use the virtual group scores under section 
1848(q)(5)(I)(i)(II) of the Act, and instead to apply the score under 
the APM scoring standard for eligible clinicians in virtual groups who 
are also in an APM Entity participating in an APM.
    Specifically, for participants in MIPS APMs, we proposed to use our 
authority under section 1115A(d)(1) of the Act for MIPS APMs authorized 
under section 1115A of the Act, and under section 1899(f) of the Act 
for the Shared Savings Program, to waive the requirement under section 
1848(q)(2)(5)(I)(i)(II) of the Act that requires performance category 
scores from virtual group reporting to be used to generate the final 
score upon which the MIPS payment adjustment is based for all TIN/NPIs 
in the virtual group. Instead, we would use the score assigned to the 
MIPS eligible clinician based on the applicable APM Entity score to 
determine MIPS payment adjustments for all MIPS eligible clinicians 
that are part of an APM Entity participating in a MIPS APM, in 
accordance with Sec.  414.1370, instead of determining MIPS payment 
adjustments for these MIPS eligible clinicians using the final score of 
their virtual group.
    We noted that MIPS eligible clinicians who are participants in both 
a virtual group and a MIPS APM would be assessed under MIPS as part of 
the virtual group and under the APM scoring standard as part of an APM 
Entity group, but would receive their payment adjustment based only on 
the APM Entity score. In the case of an eligible clinician 
participating in both a virtual group and an Advanced APM who has 
achieved QP status, the clinician would be assessed under MIPS as part 
of the virtual group, but would still be excluded from the MIPS payment 
adjustment as a result of his or her QP status. We refer readers to 
section II.C.6.g. of this final rule with comment period for further 
discussion regarding the waiver.
    The following is a summary of the public comments received 
regarding our proposals.
    Comment: Many commenters supported our proposals regarding the 
assessment and scoring of virtual group performance and the application 
of the MIPS payment adjustment to MIPS eligible clinicians based on the 
virtual group's final score.
    Response: We appreciate the support from the commenters.
    Comment: One commenter supported our proposal to assess and score 
virtual groups at the virtual group level and indicated that such an 
approach would provide comprehensive measurement, shared responsibility 
and coordination of resources, and reduce burden. Another commenter 
expressed support for requiring the aggregation of data across the TINs 
within a virtual group, including the performance data of APM 
participants, to assess the performance of a virtual group given that 
it would be difficult for TINs to separate and exclude data for some 
NPIs. One commenter supported our proposal to utilize waiver authority, 
which allows MIPS eligible clinicians within a virtual group to receive 
their MIPS payment adjustment based on the virtual group score while 
allowing APM participants who are also a part of a virtual group to 
receive their MIPS payment adjustment based on their APM Entity score 
under the APM scoring standard.
    Response: We appreciate the support from the commenters regarding 
our proposals.
    Comment: One commenter requested clarification regarding whether or 
not the MIPS payment adjustment would only apply to MIPS eligible 
clinicians within a virtual group.

[[Page 53615]]

    Response: We note that each eligible clinician in a virtual group 
will receive a virtual group score that is reflective of the combined 
performance of a virtual group; however, only MIPS eligible clinicians 
will receive a MIPS payment adjustment based on the virtual group final 
score. In the case of an eligible clinician participating in both a 
virtual group and an Advanced APM who has achieved QP status, such 
eligible clinician will be assessed under MIPS as part of the virtual 
group, but will still be excluded from the MIPS payment adjustment as a 
result of his or her QP status. Conversely, in the case of an eligible 
clinician participating in both a virtual group and an Advanced APM who 
has achieved Partial QP status, it is recognized that such eligible 
clinician would be excluded from the MIPS payment adjustment unless 
such eligible clinician elects to report under MIPS. We note that 
affirmatively agreeing to participate in MIPS as part of a virtual 
group prior to the start of the applicable performance period would 
constitute an explicit election to report under MIPS. Thus, eligible 
clinicians who participate in a virtual group and achieve Partial QP 
status would remain subject to the MIPS payment adjustment due to their 
election to report under MIPS. New Medicare-enrolled eligible 
clinicians and clinician types not included in the definition of a MIPS 
eligible clinician who are associated with a TIN that is part of a 
virtual group would receive a virtual group score, but would not 
receive a MIPS payment adjustment. MIPS eligible clinicians who are 
participants in both a virtual group and a MIPS APM will be assessed 
under MIPS as part of the virtual group and under the APM scoring 
standard as part of an APM Entity group, but will receive their payment 
adjustment based only on the APM Entity score.
    Comment: In order to increase virtual group participation and 
incentivize solo practitioners and groups (including rural and small 
practices) to form virtual groups and move toward joint accountability, 
many commenters recommended that CMS provide bonus points to TINs that 
elect to form virtual groups given that virtual groups would face 
administrative and operational challenges, such as identifying reliable 
partners, aggregating and sharing data, and coordinating workflow 
across multiple TINs and NPIs. One commenter recommended that CMS 
consider granting virtual groups (of any size) special reporting and/or 
scoring accommodations similar to the previously finalized and proposed 
policies for small practices (for example, attesting to only one to two 
improvement activities) in order to account for the short timeframe (a 
few months) TINs have to form and implement virtual groups in 
preparation for the CY 2018 performance period.
    Response: We appreciate the recommendations from commenters. We 
believe that the ability for solo practitioners and groups to form and/
or join virtual groups is an advantage and provides flexibility. We 
note that virtual groups are generally able to take advantage and 
benefit from all scoring incentives and bonuses that are currently 
provided under MIPS. We will take into consideration the development of 
additional incentives, and any changes would be proposed in future 
rulemaking.
    Comment: One commenter requested that CMS consider scoring virtual 
groups by weighting each individual group category score by the number 
of clinicians. The commenter indicated that the requirement to 
consolidate scoring for each performance category would limit the 
ability of TINs to take advantage of the virtual group option, 
particularly with regard to the advancing care information performance 
category, where the use of different EHR vendors may make finding 
viable partners difficult and preclude easy reporting. Another 
commenter indicated that our proposal to require virtual groups to be 
scored across all performance categories may cause unintended 
consequences, such as virtual groups being dissuaded from admitting 
TINs that do have EHR technology certified to the 2014 Edition in order 
for virtual groups' advancing care information performance category 
scores not to be impacted.
    Response: We believe it is important for TINs participating in MIPS 
as part of a virtual group to be assessed and scored at the virtual 
group level across each performance category. We believe it provides 
continuity in assessment and allows virtual groups to share and 
coordinate resources pertaining to each performance category. We 
recognize that there may be challenges pertaining to aligning EHR 
technology and the ways in which EHR technology captures data, but 
believe that virtual groups have the opportunity to coordinate and 
identify means to align elements of EHR technology that would benefit 
the virtual group. In order for virtual groups to accurately have their 
performance assessed and scored as a collective entity and identify 
areas to improve care coordination, quality of care, and health 
outcomes, we believe that each eligible clinician in a virtual group 
should be assessed and scored across all four performance categories at 
the virtual group level.
    Comment: One commenter suggested that CMS explore the development 
of a test to determine, in advance, if a virtual group would have 
sufficient numbers for valid measurement.
    Response: We interpret the commenter's reference to ``sufficient 
numbers for valid measurement'' to mean sufficient numerator and 
denominator data to enable the data to accurately reflect the virtual 
group's performance on specific measures and activities. As virtual 
groups are implemented, we will take this recommendation into 
consideration.
    Comment: One commenter expressed concern that virtual groups would 
have the ability to skew benchmark scoring standards to the 
disadvantage of MIPS eligible clinicians who choose not to participate 
in MIPS as part of a virtual group.
    Response: We disagree with the commenter and do not believe that 
virtual groups would skew benchmark scoring standards to the 
disadvantage of MIPS eligible clinicians participating in MIPS at the 
individual or group level as a result of how benchmarks are calculated, 
which is based on the composite of available data for all MIPS eligible 
clinicians. MIPS eligible clinicians that are participating in MIPS as 
part of a virtual group would already be eligible and able to 
participate in MIPS at the individual or group level; therefore, the 
benchmark scoring standards would not be skewed regardless of such MIPS 
eligible clinicians participating in MIPS at the individual, group, or 
virtual group level. Also, we believe that solo practitioners and 
groups with 10 or fewer eligible clinicians that form virtual groups 
would increase their performance by joining together.
    Comment: One commenter urged CMS to address risk adjustment 
mechanisms for virtual groups and develop methodologies to account for 
the unique nature of virtual groups and noted that appropriate risk 
adjustment is critical for virtual groups because of the heterogeneous 
make-up of virtual groups (for example, geographic and specialty 
diversity).
    Response: We appreciate the recommendation from the commenter. 
Under the Improving Medicare Post-Acute Transformation (IMPACT) Act of 
2014, 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

[[Page 53616]]

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.
    Comment: One commenter requested clarification regarding how 
compliance would be implemented for the quality and improvement 
activities performance categories at the virtual group level and 
whether or not a virtual group would be able to achieve the highest 
possible score for the improvement activities performance category if 
only one NPI within the virtual group meets the requirements regardless 
of the total number of NPIs participating in the virtual group. Also, 
the commenter requested clarification regarding whether or not a 
virtual group would meet the requirements under the quality performance 
category if the virtual group included a TIN that reported a specialty 
measures set that is not applicable to other eligible clinicians in the 
virtual group.
    Response: As discussed in section II.C.4.d. of this final rule with 
comment period, we are generally applying our previously finalized and 
proposed group policies to virtual groups, unless specified. Thus, in 
order for virtual groups to meet the requirements for the quality and 
improvement activities performance categories, they would need to meet 
the same requirements established for groups and meet virtual group 
reporting requirements. Virtual groups will have their performance 
assessed and scored for the quality and improvement activities 
performance categories based submitting the minimum number of measures 
and activities. Generally, virtual groups reporting quality measures 
are required to select at least 6 measures, one of which must be an 
outcome measure, or if an outcome measure is not available a high 
priority measure to collectively report for the performance period of 
CY 2018. Virtual groups are encouraged to select the quality measures 
that are most appropriate to the TINs and NPIs within their virtual 
group and patient population.
    For the 2018 performance period, virtual groups submitting data on 
quality measures using QCDRs, qualified registries, or via EHR must 
report on at least 60 percent of the virtual group's patients that meet 
the measure's denominator criteria, regardless of payer for the 
performance period. We expect to receive quality data for both Medicare 
and non-Medicare patients under these submission mechanisms. Virtual 
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 note that the measure reporting 
requirements applicable to groups are also generally applicable to 
virtual groups. However, we note that the requirements for calculating 
measures and activities when reporting via QCDRs, qualified registries, 
EHRs, and attestation differ in their application to virtual groups. 
Specifically, these requirements apply cumulatively across all TINs in 
a virtual group. Thus, virtual groups will aggregate data for each NPI 
under each TIN within the virtual group by adding together the 
numerators and denominators and then cumulatively collate to report one 
measure ratio at the virtual group level. Moreover, if each MIPS 
eligible clinician within a virtual group faces a significant hardship 
or has EHR technology that has been decertified, the virtual group can 
apply for an exception to have its advancing care information 
performance category reweighted. If such exception application is 
approved, the virtual group's advancing care information performance 
category is reweighted to zero percent and applied to the quality 
performance category increasing the quality performance weight from 50 
percent to 75 percent.
    Additionally, the data submission criteria applicable to groups are 
also generally applicable to virtual groups. However, we note that data 
completeness and sampling requirements for the CMS Web Interface and 
CAHPS for MIPS survey differ in their application to virtual groups. 
Specifically, data completeness for virtual groups applies cumulatively 
across all TINs in a virtual group. Thus, we note that there may be a 
case when a virtual group has one TIN that falls below the 60 percent 
data completeness threshold, which is an acceptable case as long as the 
virtual group cumulatively exceeds such threshold. In regard to the CMS 
Web Interface and CAHPS for MIPS survey, sampling requirements pertain 
to Medicare Part B patients with respect to all TINs in a virtual 
group, where the sampling methodology would be conducted for each TIN 
within the virtual group and then cumulatively aggregated across the 
virtual group. A virtual group would need to meet the beneficiary 
sampling threshold cumulatively as a virtual group.
    In regard to performance under the improvement activities 
performance category, we clarified in the CY 2017 Quality Payment 
Program final rule (81 FR 77181) that if one MIPS eligible clinician 
(NPI) in a group completed an improvement activity, the entire group 
(TIN) would receive credit for that activity. In addition, we specified 
that all MIPS eligible clinicians reporting as a group would receive 
the same score for the improvement activities performance category if 
at least one clinician within the group is performing the activity for 
a continuous 90 days in the performance period. As discussed in section 
II.C.4.d. of this final rule with comment period, we are finalizing our 
proposal to generally apply our previously finalized and proposed group 
policies to virtual groups, unless otherwise specified. Thus, if one 
MIPS eligible clinician (NPI) in a virtual group completed an 
improvement activity, the entire virtual group would receive credit for 
that activity and receive the same score for the improvement activities 
performance category if at least one clinician within the virtual group 
is performing the activity for a minimum of a continuous 90-day period 
in CY 2018. In order for virtual groups to achieve full credit under 
the improvement activities performance category for the 2018 
performance period, they would need to submit four medium-weighted or 
two high-weighted activities that were for a minimum of a continuous 
90-day period in CY 2018. Virtual groups that are considered to be non-
patient facing or small practices, or designated as rural or HPSA 
practices will receive full credit by submitting one high-weighted 
improvement activity or two medium-weighted improvement activities that 
were conducted for a minimum of a continuous 90-day period in CY 2018.
    In regard to compliance with quality and improvement activities 
performance category requirements, virtual groups would meet the same 
performance category requirements applicable to groups. In section 
II.C.4.g. of this final rule with comment period, we outline virtual 
group reporting requirements. Virtual groups are required to adhere to 
the requirements established for each performance category. Performance 
data submitted to CMS on behalf of virtual groups must be meet form and 
manner requirements for each submission mechanism.

[[Page 53617]]

    Final Action: After consideration of the public comments received, 
we are finalizing the following proposals. Solo practitioners and 
groups with 10 or fewer eligible clinicians that have elected to be 
part of a virtual group will have their performance measured and 
aggregated at the virtual group level across all four performance 
categories. We will apply payment adjustments at the individual TIN/NPI 
level. Each TIN/NPI will receive a final score based on the virtual 
group performance, but the payment adjustment would still be applied at 
the TIN/NPI level. We will assign the virtual group score to all TIN/
NPIs billing under a TIN in the virtual group during the performance 
period.
    For participants in MIPS APMs, we will use our authority under 
section 1115A(d)(1) for MIPS APM authorized under section 1115A of the 
Act, and under section 1899(f) for the Shared Savings Program, to waive 
the requirement under section 1848 (q)(2)(5)(I)(i)(II) of the Act that 
requires performance category scores from virtual group reporting to be 
used to generate the final score upon which the MIPS payment adjustment 
is based for all TIN/NPIs in the virtual group. We will use the score 
assigned to the MIPS eligible clinician based on the applicable APM 
Entity score to determine MIPS payment adjustments for all MIPS 
eligible clinicians that are part of an APM Entity participating in a 
MIPS APM, in accordance with Sec.  414.1370, instead of determining 
MIPS payment adjustments for these MIPS eligible clinicians using the 
final score of their virtual group.
5. MIPS Performance Period
    In the CY 2017 Quality Payment Program final rule (81 FR 77085), we 
finalized 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). We finalized 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 did not propose any changes to these policies.
    We also finalized at Sec.  414.1325(f)(2) that for Medicare Part B 
claims, data must be submitted on claims with dates of service during 
the performance period that must be processed no later than 60 days 
following the close of the performance period. In this final rule with 
comment period, we are finalizing three policies (small practice size 
determination, non-patient facing determination, and low-volume 
threshold determination) that utilize a 30-day claims run out. We refer 
readers to sections II.C.l.c., II.C.l.e., and II.C.2.c. of this final 
rule with comment period for details on these three policies. Lastly, 
we finalized that individual MIPS eligible clinicians or groups who 
report less than 12 months of data (due to family leave, etc.) are 
required to report all performance data available from the applicable 
performance period (for example, CY 2018 or a minimum of a continuous 
90-day period within CY 2018).
    We proposed at Sec.  414.1320(c)(1) that for purposes of the 2021 
MIPS payment year and future years, the performance period for the 
quality and cost performance categories would be the full calendar year 
(January 1 through December 31) that occurs 2 years prior to the 
applicable payment year. For example, for the 2021 MIPS payment year, 
the performance period would be CY 2019 (January 1, 2019 through 
December 31, 2019), and for the 2022 MIPS payment year, the performance 
period would be CY 2020 (January 1, 2020 through December 31, 2020).
    We proposed at Sec.  414.1320(d)(1) that for purposes of the 2021 
MIPS payment year, the performance period for the improvement 
activities and advancing care information performance categories would 
be a minimum of a continuous 90-day period within CY 2019, up to and 
including the full CY 2019 (January 1, 2019 through December 31, 2019).
    The following is a summary of the public comments received on the 
``MIPS Performance Period'' proposals and our responses:
    Comment: Many commenters did not support our proposal that 
beginning with the 2021 MIPS payment year, the performance period for 
the quality and cost performance categories would be the full calendar 
year that occurs 2 years prior to the applicable payment year. The 
commenters believed that MIPS eligible clinicians are not prepared to 
move from ``pick your pace'' flexibility to a full calendar year 
performance period and that the proposal would create significant 
administrative burden and confusion for MIPS eligible clinicians. A few 
commenters noted that a full calendar year of data does not necessarily 
improve the validity of the data. Many commenters recommended that CMS 
continue ``pick your pace'' flexibility with respect to the performance 
period, while several commenters expressed an interest in CMS allowing 
clinicians to choose the length of their performance period. One 
commenter recommended that CMS provide bonus points to clinicians who 
report for a performance period that is longer than 90 days. A few 
commenters recommended that CMS analyze the quality and cost 
performance data to determine the appropriate length of the performance 
period, taking into consideration whether there are any unintended 
consequences for practices of a particular size or specialty. One 
commenter suggested that CMS work with physicians to develop options 
and a specific plan to provide accommodations where possible, such as 
providing clinicians multiple different performance periods to choose 
from. A few commenters noted that a 90-day performance period may 
eliminate issues for clinicians that either switch or update their EHR 
system during the performance period. Furthermore, a few commenters 
noted that since the QCDR self-nominations are not due until November 
1, 2017, CMS would need to review and approve QCDR measures within less 
than 2 months, for clinicians to have QCDR measures to report at the 
start of the CY 2018 performance period. One commenter noted that a 90-
day performance period is preferable as clinicians will need time to 
update their systems and train staff after QCDR measures have been 
approved.
    Response: We understand the commenters' concerns. However, we 
believe that it would not be in the best interest of MIPS eligible 
clinicians to have less than a full calendar year performance period 
for the quality and cost performance categories beginning with the 2021 
MIPS payment year, as we previously finalized at Sec.  414.1320(b)(1) a 
full calendar year performance period for the quality and cost 
performance categories for the 2020 MIPS payment year, which will occur 
during CY 2018. By finalizing a full calendar year performance period 
for the quality and cost performance categories for the 2021 MIPS 
payment year, we are maintaining consistency with the performance 
period for the 2020 MIPS payment year. We believe this will be less 
burdensome and confusing for MIPS eligible clinicians. We also would 
like to note that a longer performance period for the quality and cost 
performance categories will likely include more patient encounters, 
which will increase the denominator of the quality and cost measures. 
Statistically, larger sample sizes provide more accurate and actionable 
information. Additionally, the longer performance

[[Page 53618]]

period (a year) is consistent with how many of the measures used in our 
program were designed to be reported and performed, such as Quality 
#303 (Cataracts: Improvement in Patient's Visual Function within 90 
Days Following Cataract Surgery) and Quality #304 (Cataracts: Patient 
Satisfaction within 90 Days Following Cataract Surgery). Finally, some 
of the measures do not allow for a 90-day performance period (such as 
those looking at complications after certain surgeries or improvement 
in certain conditions after treatment). In regards to the 
recommendation of providing bonus points to MIPS eligible clinicians 
that report for a performance period longer than 90 days, we believe a 
more appropriate incentive is for MIPS eligible clinicians to perform 
on a full year so that they have the ability to improve their 
performance due to having a larger sample size, etc. We also understand 
the commenters' preference of a 90-day performance period, so that 
there is adequate time to update systems and train staff. We agree that 
adequate time is needed to update systems, workflows and train staff. 
However, we note that the quality measures are finalized as part of 
this final rule, and the specifications are published on our Web site 
by no later than December 31 prior to the performance period. While we 
strongly encourage all clinicians to review the current performance 
period's measure specifications, we note that the overwhelming majority 
of MIPS quality measures are maintained year over year with only minor 
code set updates. Further, for quality, we have a 60 percent data 
completeness threshold, which provides a buffer for clinicians if they 
are not able to implement their selected measures immediately at the 
start of the performance period. Finally, we would like to clarify that 
many registries, QCDRs, and EHRs have the ability to accept historical 
data so that once the EHR system is switched or updated, the MIPS 
eligible clinician can report their information. With regard to the 
suggestion that we work with physicians to develop options and a 
specific plan to provide accommodations where possible, such as 
providing clinicians multiple different performance periods to choose 
from, we will consider this suggestion for future rulemaking as 
necessary.
    Comment: While we did not propose any changes to the previously 
finalized performance periods for the 2020 MIPS payment year, many 
commenters did not support a full calendar year performance period for 
the quality performance category for the 2020 MIPS payment year. The 
commenters noted that MIPS eligible clinicians are not prepared to move 
from ``pick your pace'' flexibility to a full calendar year performance 
period and that this policy will create significant administrative 
burden and confusion for MIPS eligible clinicians.
    Response: We understand the commenters' concerns in regards to the 
full calendar year MIPS performance period for the quality performance 
category for the 2020 MIPS payment year. We would like to note that the 
MIPS performance period for the 2020 MIPS payment year was finalized in 
the CY 2017 Quality Payment Program final rule, and we made no new 
proposals for the MIPS performance period for the 2020 MIPS payment 
year. Therefore, we are unable to modify the MIPS performance period 
for the quality performance category for the 2020 MIPS payment year.
    Comment: Several commenters supported the proposal to increase the 
performance period for the 2021 MIPS payment year and future payment 
years to 12 months occurring 2 years prior because the longer 
performance period provides a more accurate picture of eligible 
clinicians' performance. A few commenters noted that their support was 
contingent on CMS approving 2018 QCDR measure specifications by 
December 1, 2017. One commenter noted that a 90-day performance period 
is insufficient to thoroughly assess performance. One commenter noted 
that the full year will ensure continuity in the quality of care 
delivered to beneficiaries. One commenter noted that a TIN 
participating in Track 1 of the Shared Savings Program is automatically 
required to report for the full year, so requiring all MIPS eligible 
clinicians to participate for a full year would be fairer now that 
scores are reflected on Physician Compare.
    Response: We thank the commenters for their support. We would also 
like to note that in the CY 2017 Quality Payment Program final rule (81 
FR 77158), we stated that we would post the approved QCDR measures 
through the qualified posting by no later than January 1, 2018.
    Comment: A few commenters did not support the proposed performance 
periods because the quality and cost performance categories would not 
be aligned with the improvement activities and advancing care 
information performance categories. The commenters believed it would be 
confusing to clinicians. One commenter recommended that all performance 
categories have a 12-month performance period.
    Response: We understand the commenters' concerns that the proposed 
performance periods for quality and cost would not be consistent with 
the improvement activities and advancing care information performance 
categories. For the improvement activities performance category, a 
minimum of a continuous 90-day performance period provides MIPS 
eligible clinicians more flexibility as some improvement activities may 
be ongoing, while others may be episodic. For the advancing care 
information performance category, a minimum of a continuous 90-day 
period performance period provides MIPS eligible clinicians more 
flexibility and time to adopt and implement 2015 Edition CEHRT. As for 
the quality and cost performance categories, we believe that a full 
calendar year performance period is most appropriate. Additionally, 
submitting only 90 days of performance data may create challenges for 
specific measures. Finally, with respect to the cost performance 
category, we would like to note that no data submission is required, as 
this performance category is calculated utilizing Part B claim data.
    Comment: Many commenters supported the proposed 90-day performance 
period for the improvement activities and advancing care information 
performance categories. A few commenters requested that CMS adopt a 90-
day performance period for the improvement activities and advancing 
care information performance categories for the 2022 MIPS payment year 
and future years.
    Response: We thank the commenters for their support and will 
consider the commenters' recommendation for future rulemaking.
    Comment: A few commenters did not support the length of time 
between the proposed performance period and the applicable payment year 
because the commenters believed it would not allow practices time to 
make necessary adjustments before the next performance period begins. 
One commenter recommended that, as the program matures, one 
consideration for shortening this timeframe could be a quarterly 
rolling annual performance period with a three- to 6-month validation 
period prior to any payment adjustment. Another commenter recommended 
that we consider staggered performance periods; for example payment 
adjustments for 2021, would ideally be based on a performance period 
running from July 1, 2019 through June 30, 2020.
    Response: We understand the commenters' concerns regarding the 
length of time between the proposed

[[Page 53619]]

performance period and the applicable payment year and appreciate the 
commenters' suggestions for shortening this timeframe. While a 
shortened timeframe between performance period and payment year may be 
desirable, there are operational challenges with this approach that we 
do not anticipate can be resolved in the near future. Specifically, we 
need to allow time for the post submission processes of calculating 
MIPS eligible clinicians' final scores, establishing budget neutrality, 
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. However, we are 
continuing to look for opportunities to shorten the timeframe between 
the end of the performance period and when payment adjustments are 
applied.
    Comment: One commenter recommended a 2-year performance period for 
clinicians who have patient volume insufficient for statistical 
analysis so that the clinician has a sufficient sample size to analyze.
    Response: We thank the commenter for their suggestion and will 
consider it for future rulemaking. We would like to note that in this 
final rule with comment period, we are only finalizing the performance 
period for the 2021 MIPS payment year, not future years, so that we can 
continue to monitor and assess whether changes to the performance 
period through future rulemaking would be beneficial.
    Comment: One commenter encouraged CMS to implement the MIPS program 
as soon as possible. This commenter noted that a transition period 
could discourage eligible clinicians from participating in the program.
    Response: We appreciate the commenter's recommendation to implement 
the MIPS program as soon as possible; however, we disagree that a 
transition period will discourage participation. We believe that a 
transition period will reduce barriers from participation that existed 
in the legacy programs.
    Final Action: After consideration of the public comments, we are 
finalizing at Sec.  414.1320(c)(1) that for purposes of the 2021 MIPS 
payment year, the performance period for the quality and cost 
performance categories is CY 2019 (January 1, 2019 through December 31, 
2019). We are not finalizing the proposed performance period for the 
quality and cost performance categories for purposes of the 2022 MIPS 
payment year and future years. We are also redesignating proposed Sec.  
414.1320(d)(1) and finalizing at Sec.  414.1320(c)(2) that for purposes 
of the 2021 MIPS payment year, the performance period for the advancing 
care information and improvement activities performance categories is a 
minimum of a continuous 90-day period within CY 2019, up to and 
including the full CY 2019 (January 1, 2019 through December 31, 2019).
6. MIPS Performance Category Measures and Activities
a. Performance Category Measures and Reporting
(1) Submission Mechanisms
    We finalized in the CY 2017 Quality Payment Program final rule (81 
FR 77094) at Sec.  414.1325(a) that individual MIPS eligible clinicians 
and groups must submit measures and activities, as applicable, for the 
quality, improvement activities, and advancing care information 
performance categories. For the cost performance category, we finalized 
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 are not required 
to submit any additional information for the cost performance category. 
We finalized in the CY 2017 Quality Payment Program final rule (81 FR 
77094 through 77095) multiple data submission mechanisms for MIPS, 
which provide individual MIPS eligible clinicians and groups with the 
flexibility to submit their MIPS measures and activities in a manner 
that best accommodates the characteristics of their practice, as 
indicated in Tables 2 and 3. Table 2 summarizes the data submission 
mechanisms for individual MIPS eligible clinicians that we finalized at 
Sec.  414.1325(b) and (e). Table 3 summarizes the data submission 
mechanisms for groups that are not reporting through an APM that we 
finalized at Sec.  414.1325(c) and (e).

    Table 2--Data Submission Mechanisms for MIPS Eligible Clinicians
                         Reporting Individually
                                [TIN/NPI]
------------------------------------------------------------------------
  Performance category/submission   Individual reporting data submission
       combinations accepted                     mechanisms
------------------------------------------------------------------------
Quality...........................  Claims.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
Cost..............................  Administrative claims.\1\
Advancing Care Information........  Attestation.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
Improvement Activities............  Attestation.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
------------------------------------------------------------------------


    Table 3--Data Submission Mechanisms for MIPS Eligible Clinicians
                           Reporting as Groups
                                  [TIN]
------------------------------------------------------------------------
  Performance category/submission      Group reporting data submission
       combinations accepted                     mechanisms
------------------------------------------------------------------------
Quality...........................  QCDR.
                                    Qualified registry.
                                    EHR.

[[Page 53620]]

 
                                    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.\1\
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).
------------------------------------------------------------------------

    We finalized at Sec.  414.1325(d) that individual 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.
---------------------------------------------------------------------------

    \1\ Requires no separate data submission to CMS: Measures are 
calculated based on data available from MIPS eligible clinicians' 
billings on Medicare Part B claims. Note: Claims differ from 
administrative claims as they require MIPS eligible clinicians to 
append certain billing codes to denominator eligible claims to 
indicate the required quality action or exclusion occurred.
---------------------------------------------------------------------------

    We proposed to revise Sec.  414.1325(d) for purposes of the 2020 
MIPS payment year and future years, beginning with performance periods 
occurring in 2018, to allow individual MIPS eligible clinicians and 
groups to submit data on measures and activities, as applicable and 
available, via multiple data submission mechanisms for a single 
performance category (specifically, the quality, improvement 
activities, or advancing care information performance category) (82 FR 
30035). Under this proposal, individual MIPS eligible clinicians and 
groups that have fewer than the required number of measures and 
activities applicable and available under one submission mechanism 
could submit data on additional measures and activities via one or more 
additional submission mechanisms, as necessary, to receive a potential 
maximum number of points under a performance category.
    If an individual MIPS eligible clinician or group submits the same 
measure through two different mechanisms, each submission would be 
calculated and scored separately. We do not have the ability to 
aggregate data on the same measure across submission mechanisms. We 
would only count the submission that gives the clinician the higher 
score, thereby avoiding the double count. We refer readers to section 
II.C.7.a.(2) of this final rule with comment period, which further 
outlines how we proposed to score measures and activities regardless of 
submission mechanism.
    We believe that this flexible approach would help individual MIPS 
eligible clinicians and groups with reporting, as it provides more 
options for the submission of data for the applicable performance 
categories. We believe that by providing this flexibility, we would be 
allowing MIPS eligible clinicians to choose the measures and activities 
that are most meaningful to them, regardless of the submission 
mechanism. We are aware that this proposal for increased flexibility in 
data submission mechanisms may increase complexity and in some 
instances necessitate additional costs for clinicians, as they may need 
to establish relationships with additional data submission mechanism 
vendors in order to report additional measures and/or activities for 
any given performance category. We clarified that the requirements for 
the performance categories remain the same, regardless of the number of 
submission mechanisms used. It is also important to note that for the 
improvement activities and advancing care information performance 
categories, that using multiple data submission mechanisms may limit 
our ability to provide real-time feedback. While we strive to provide 
flexibility to individual MIPS eligible clinicians and groups, we noted 
that our goal within the MIPS program is to minimize complexity and 
administrative burden to individual MIPS eligible clinicians and 
groups.
    As discussed in section II.C.4 of this final rule with comment 
period, we proposed to generally apply our previously finalized and 
proposed group policies to virtual groups. With respect to data 
submission mechanisms, we proposed that virtual groups would be able to 
use a different submission mechanism for each performance category, and 
would be able to utilize multiple submission mechanisms for the quality 
performance category, beginning with performance periods occurring in 
2018 (82 FR 30036). However, virtual groups would be required to 
utilize the same submission mechanism for the improvement activities 
and the advancing care information performance categories.
    For those MIPS eligible clinicians participating in a MIPS APM, who 
are on an APM Participant List on at least one of the three snapshot 
dates as finalized in the CY 2017 Quality Payment Program Final Rule 
(81 FR 77444 through 77445), or for MIPS eligible clinicians 
participating in a full TIN MIPS APM, who are on an APM Participant 
List on at least one of the four snapshot dates as discussed in section 
II.C.6.g.(2) of this final rule with comment period, the APM scoring 
standard applies. We refer readers to Sec.  414.1370 and the CY 2017 
Quality Payment Program final rule (81 FR 77246), which describes how 
MIPS eligible clinicians participating in APM entities submit data to 
MIPS in the form and manner required, including separate approaches to 
the quality and cost performance categories applicable to MIPS APMs. We 
did not propose any changes to how APM entities in MIPS APMs and their 
participating MIPS eligible clinicians submit data to MIPS.

[[Page 53621]]

    The following is a summary of the public comments received on the 
``Performance Category Measures and Reporting: Submission Mechanisms'' 
proposal and our responses:
    Comment: Many commenters supported the proposal to allow MIPS 
eligible clinicians and groups to submit measures and activities via 
multiple submission mechanisms. Several commenters noted it will help 
ease reporting and administrative burden. Several commenters also noted 
it will provide greater flexibility, including increasing the number of 
measures available. Several commenters stated it will allow clinicians 
to report the measures that are most meaningful and applicable to them. 
Several commenters also stated it will help MIPS eligible clinicians 
and groups successfully report required measures and meet MIPS 
reporting requirements. A few commenters specifically supported the 
policy to allow reporting of quality measures across multiple data 
submission mechanisms because 6 clinically-applicable quality measures 
may not always be available using one submission mechanism; it will 
provide clinicians who belong to multi-specialty groups more ease in 
reporting quality measures they may be already reporting to qualified 
vendors, versus forcing different specialties to find a common 
reporting platform that causes much more administrative, and often 
financial burden; it will allow greater flexibility in measure 
selection and will particularly benefit specialists who may want to 
report one or 2 eCQMs but will need to use a registry to report the 
rest of their measure set; and it is especially helpful for those who 
want to report via EHR to the extent possible even though not all 
measures can be submitted via that mechanism. One commenter asked if 
specialists who would have used a specialty measure set would be 
required to use multiple submission methods to meet the 6-measure 
requirement.
    Response: We appreciate the commenters support for our proposal. 
Due to operational feasibility concerns, we are not finalizing this 
proposal beginning with the CY 2018 performance period as proposed, but 
instead beginning with the CY 2019 performance period. Moreover, we are 
not requiring that MIPS individual clinicians and groups submit via 
additional submission mechanisms; however, through this proposal the 
option would be available for those that have applicable measures and/
or activities available to them. As discussed in section 
II.C.7.a.(2)(e) of this final rule with comment period, beginning with 
the CY 2019 performance period, we will apply our validation process to 
determine if other measures are available and applicable only with 
respect to the data submission mechanism(s) that a MIPS eligible 
clinician utilizes for the quality performance category for a 
performance period. With regard to a specialty measure set, specialists 
who report on a speciality measure set are only required to report on 
the measures within that set, even if it is less than the required 6 
measures. If the specialty set includes measures that are available 
through multiple submission mechanisms, then through this policy, 
beginning with the 2019 performance period, the option to report 
additional measures would be available for those that have applicable 
measures and/or activities available to them, which may potentially 
increase their score, but they are not required to utilize multiple 
submission methods to meet the 6 measure requirement. In addition, for 
MIPS eligible clinicians reporting on a specialty measure set via 
claims or registry, we will apply our validation process to determine 
if other measures are available and applicable within the specialty 
measure set only with respect to the data submission mechanism(s) that 
a MIPS eligible clinician utilizes for the quality performance category 
for a performance period.
    Comment: A few commenters stated this proposal will allow MIPS 
eligible clinicians to determine which method is most appropriate for 
the different MIPS categories. Several commenters noted it will 
encourage MIPS participation. Many commenters stated it will encourage 
the reporting of measures through new submission methods such as QCDRs 
and EHRs. A few commenters stated it will reduce burden on clinicians 
and EHR vendors by allowing large groups that report under different 
EHRs to report using multiple EHRs.
    Response: In the CY 2017 Quality Payment Program final rule, we 
finalized that for the quality performance category, an individual MIPS 
eligible clinician or group that submits data on quality measures via 
EHR, QCDR, qualified registry, claims, or a CMS-approved survey vendor 
for the CAHPS for MIPS survey will be assigned measure achievement 
points for 6 measures (1 outcome, or if an outcome measure is not 
available, another high priority measure and the next 5 highest scoring 
measures) as available and applicable, and we will receive applicable 
measure bonus points for all measures submitted that meet the bonus 
criteria (81 FR 77282 through 77301). Consistent with this policy, we 
would like to clarify that for performance periods beginning in 2019, 
if a MIPS eligible clinician or group reports for the quality 
performance category by using multiple instances of the same data 
submission mechanism (for example, multiple EHRs) then all the 
submissions would be scored, and the 6 quality measures with the 
highest performance (that is, the greatest number of measure 
achievement points) would be utilized for the quality performance 
category score. As noted above, if an individual MIPS eligible 
clinician or group submits the same measure through two different 
mechanisms, each submission would be calculated and scored separately. 
We do not have the ability to aggregate data on the same measure across 
multiple submission mechanisms. We would only count the submission that 
gives the clinician the higher score, thereby avoiding the double 
count. For example, if a MIPS eligible clinician submits performance 
data for Quality Measure 236, Controlling High Blood Pressure, using a 
registry and also through an EHR, these two submissions would be scored 
separately, and we would apply the submission with the higher score 
towards the quality performance score. We would not aggregate the score 
of the registry and EHR submission of the same measure. This approach 
decreases the likelihood of cumulative overcounting in the event that 
the submissions may have time or patient overlaps that may not be 
readily identifiable.
    Comment: One commenter supported that virtual groups would be able 
to use multiple submission mechanisms for quality reporting but would 
have to use the same submission mechanism for the improvement 
activities and advancing care information performance categories. A few 
commenters suggested that both groups and virtual groups have the same 
submission requirements. Another commenter suggested that we reconsider 
multiple submission mechanisms due to the complexity it will place on 
clinicians.
    Response: We are not finalizing our proposal that virtual groups 
would be required to utilize the same submission mechanism for the 
improvement activities and the advancing care information performance 
categories because we believe that virtual groups should have the same 
reporting capabilities as groups. Thus, groups and virtual groups have 
the same submission requirements, which for the CY 2018 performance 
period, includes the utilization of multiple submission mechanisms with 
the caveat that only one submission mechanism must be used per 
performance category. Starting

[[Page 53622]]

with the CY 2019 performance period, groups and virtual groups will be 
able to utilize multiple submission mechanisms for each performance 
category. As noted above, due to operational feasibility concerns, we 
are not finalizing this proposal beginning with the CY 2018 performance 
period as proposed, but instead beginning with the CY 2019 performance 
period.
    Comment: A few commenters stated this proposal would help 
clinicians and groups receive the maximum number of points available. 
One commenter noted it will ease the path for small and rural practice 
clinicians to participate in MIPS. One commenter stated it will support 
reporting the highest quality data available. One commenter noted it 
may allow clinicians to complete more activities. One commenter noted 
it will provide EHR and registry vendors flexibility in submitting data 
on behalf of their customers. One commenter stated that while it may 
add some burdens to reporting quality measures because MIPS eligible 
clinicians will be required to report on 6 quality measures instead of 
only the number available via a given submission mechanism, they stated 
that they believe it will ultimately drive adoption of more robust 
measures based on clinical data and outcomes.
    Response: We note that under this policy, individual MIPS eligible 
clinicians and groups are not required to, but may use multiple data 
submission mechanisms to report on six quality measures in order to 
potentially achieve the maximum score for the quality performance 
category beginning with the 2019 performance period. Individual MIPS 
eligible clinicians and groups could report on additional measures and/
or activities using multiple data submission mechanisms for the 
Quality, Advancing Care Information, and Improvement Activities 
performance categories should applicable measures and/or activities be 
available to them. We agree that this policy provides small and rural 
practice clinicians with additional flexibility to participate in MIPS 
by not limiting them to the use of one submission mechanism per 
performance category. We believe that MIPS eligible clinicians and 
groups should select and report on measures that provide meaningful 
measurement within the scope of their practice that should include a 
focus on more outcomes-based measurement.
    Comment: One commenter who supported the proposal expressed concern 
that the flexibility may create more complexity and confusion, as well 
as burden on CMS. Another commenter stated that while there could be 
some burdens with requiring clinicians to use multiple submission 
mechanisms, if they have fewer than the required number of measures and 
activities applicable and available under one submission mechanism, as 
the requirements for the performance categories remain the same 
regardless of the number of submission mechanisms used. A commenter 
expressed concern with making multiple submissions part of the measure 
validation process for the review of whether 6 measures are available 
for reporting.
    Response: We appreciate the commenters support for our proposal. 
Due to operational feasibility concerns, we are not finalizing this 
proposal beginning with the CY 2018 performance period as proposed, but 
instead beginning with the CY 2019 performance period. Moreover, we are 
not requiring that MIPS individual clinicians and groups submit via 
additional submission mechanisms; however, through this proposal the 
option would be available for those that have applicable measures and/
or activities available to them. As discussed in section 
II.C.7.a.(2)(e) of this final rule with comment period, beginning with 
the CY 2019 performance period, we will apply our validation process to 
determine if other measures are available and applicable only with 
respect to the data submission mechanism(s) that a MIPS eligible 
clinician utilizes for the quality performance category for a 
performance period. With regard to a specialty measure set, specialists 
who report on a speciality measure set are only required to report on 
the measures within that set, even if it is less than the required 6 
measures. If the specialty set includes measures that are available 
through multiple submission mechanisms, then through this policy, 
beginning with the 2019 performance period, the option to report 
additional measures would be available for those that have applicable 
measures and/or activities available to them, which may potentially 
increase their score, but they are not required to utilize multiple 
submission methods to meet the 6 measure requirement. In addition, for 
MIPS eligible clinicians reporting on a specialty measure set via 
claims or registry, we will apply our validation process to determine 
if other measures are available and applicable within the specialty 
measure set only with respect to the data submission mechanism(s) that 
a MIPS eligible clinician utilizes for the quality performance category 
for a performance period.
    Comment: A few commenters offered additional recommendations 
including: That CMS eventually require a MIPS eligible clinician or 
group to submit all data on measures and activities across a single 
data submission mechanism of their choosing to ensure that reliable, 
trustworthy, comparative data can be extracted from the MIPS eligible 
clinician and/or group's MIPS performance information and to alleviate 
the resource intensity associated with retaining all data across the 
multiple submission mechanisms for auditing purposes; and that claims-
only reporting for the quality performance category be phased-out due 
to difficulty with clinically abstracting meaningful quality data.
    Response: We thank the commenter for their recommendations 
regarding using a single data submission mechanism and phasing out 
claims-only reporting for the quality performance category, and will 
take their recommendations into consideration for future rulemaking. We 
refer readers to section II.C.9.c of this final rule with comment 
period for a discussion of our data validation and auditing policies.
    Comment: Commenters requested that CMS continue to look for ways to 
increase flexibility in the Quality Payment Program and believed the 
best way to ensure participating clinicians can meet the requirements 
of each performance category is to increase the number of meaningful 
measures available. For clinicians who do not want to manage multiple 
submission mechanisms an alternative solution would be for each 
specialty within a group to create their own TINs and report as 
subgroups, because the commenter stated that allowing all MIPS eligible 
groups to report unique sets of measures via a single mechanism or 
multiple mechanisms promotes the ability for all clinicians to have a 
meaningful impact on overall MIPS performance, although the commenter 
recognized that this subgroup approach could create challenges with the 
current MIPS group scoring methodology.
    Response: We agree that reporting on quality measures should be 
meaningful for clinicians, and note that measures are taken into 
consideration on an annual basis prior to rule-making and we encourage 
stakeholders to communicate their concerns regarding gaps in measure 
development to measure stewards. We thank commenters for their 
suggestions regarding an alternative approach to submission mechanisms. 
We would like to clarify that each newly created TIN would be 
considered a new group, and as discussed in the CY 2018 Quality Payment 
Program proposed rule (82 FR 30027), we intend to explore the

[[Page 53623]]

feasibility of establishing group-related policies that would permit 
participation in MIPS at a subgroup level through future rulemaking. We 
refer readers section II.C.3. of this final rule with comment period 
for additional information regarding group reporting.
    Comment: Commenters suggested that CMS ensure that entire specialty 
specific measure sets can be reported through a single submission 
mechanism of their choice, specifically expressing concern for the 
measures within the radiation oncology subspecialty measure set.
    Response: We would like to note that a majority of the measures in 
the specialty measure sets are available through registry reporting, 
and that specifically to the commenters concern, that all the measures 
within the radiation oncology subspecialty measure set are available 
through registry reporting. A majority of the quality measures in the 
MIPS program are not owned by CMS, but rather are developed and 
maintained by third party measure stewards. As a part of measure 
development and maintenance, measure stewards conduct feasibility 
testing of adding a new submission mechanism as a reporting option for 
their measure. We will share this recommendation with the measure 
stewards for future consideration.
    Comment: One commenter suggested that CMS retroactively provide 
similar flexibility for the CY 2017 MIPS performance period.
    Response: For operational and feasibility reasons, we believe that 
it would not be possible to retroactively allow MIPS individual 
eligible clinicians and groups to submit data through multiple 
submission mechanisms for the CY 2017 MIPS performance period.
    Comment: Some commenters suggested that CMS not overly rely on 
claims-based measures to drive quality improvement and scoring in 
future program years, that CMS develop a transition plan toward only 
accepting data from electronic systems that have demonstrated abilities 
to produce valid measurement, such as those EHRs that have achieved 
NCQA eMeasure Certification; and that CMS create educational programs 
to help clinicians and groups understand the multiple submission 
option. A few commenters recommended making more quality measures 
available under each of the submission mechanisms so MIPS eligible 
clinicians have sufficient measures within a single submission 
mechanism. One commenter stated it would inadvertently advantage large 
practices that may be better equipped to track measures. One commenter 
asked for clarification to distinguish between the scenarios where a 
clinician is required to submit under both EHR and registry because 
their EHR is not certified for enough measures and when a clinician is 
required to submit under both EHR and registry because CMS has not 
created enough electronic measures for the clinician's specialty.
    Response: We appreciate the suggestions, and will take them into 
consideration for future rulemaking. As indicated in the CY 2017 
Quality Payment Program final rule (81 FR 77090), we intend to reduce 
the number of claims-based measures in the future as more measures are 
available through health IT mechanisms that produce valid measurement 
such as registries, QCDRs, and health IT vendors. We plan to 
continuously work with MIPS eligible clinicians and other stakeholders 
to continue to improve the submission mechanisms available for MIPS. We 
agree that there is value to EHR based reporting; however, we recognize 
that there are relatively fewer measures available via EHR reporting 
and we generally want to retain solutions that are low burden unless 
and until we identify viable alternatives. As indicated in the quality 
measures appendices in this final rule with comment period, we are 
finalizing 54 out of the 275 quality measures available through EHR 
reporting for the CY 2018 performance period. MIPS eligible clinicians 
should evaluate the options available to them and choose which 
available submission mechanism and measures they believe will provide 
meaningful measurement for their scope of practice. We intend to 
provide stakeholders with additional education with regards to the use 
of multiple submission mechanisms by the implementation of this policy 
for the CY 2019 performance period. We plan to continuously work with 
MIPS eligible clinicians and other stakeholders to continue to improve 
the submission mechanisms available for MIPS. It is not our intent to 
provide larger practices an advantage over smaller practices, rather 
our intention is to provide all MIPS eligible clinicians and groups the 
opportunity to submit data on measures that are available and 
applicable to their scope of practice. We are not requiring that MIPS 
individual clinicians and groups submit via additional submission 
mechanisms; however, through this proposal the option would be 
available for those that have applicable measures and/or activities 
available to them. As discussed in section II.C.7.a.(2)(e) of this 
final rule with comment period, beginning with the CY 2019 performance 
period, we will apply our validation process to determine if other 
measures are available and applicable only with respect to the data 
submission mechanism(s) that a MIPS eligible clinician utilizes for the 
quality performance category for a performance period. With regard to a 
specialty measure set, specialists who report on a speciality measure 
set are only required to report on the measures within that set, even 
if it is less than the required 6 measures. If the specialty set 
includes measures that are available through multiple submission 
mechanisms, then through this policy, beginning with the 2019 
performance period, the option to report additional measures would be 
available for those that have applicable measures and/or activities 
available to them, which may potentially increase their score, but they 
are not required to utilize multiple submission methods to meet the 6 
measure requirement. In addition, for MIPS eligible clinicians 
reporting on a specialty measure set via claims or registry, we will 
apply our validation process to determine if other measures are 
available and applicable within the specialty measure set only with 
respect to the data submission mechanism(s) that a MIPS eligible 
clinician utilizes for the quality performance category for a 
performance period.
    Comment: Several commenters recommended that CMS make multiple 
submission mechanisms optional only. A few commenters expressed concern 
that a requirement to report via multiple mechanisms to meet the 
required 6 measures in the quality performance category would increase 
burden on MIPS eligible clinicians and groups that are unable to meet 
the minimum requirement using one submission mechanism. A few 
commenters stated that MIPS eligible clinicians and groups should not 
be required to contract with vendors and pay to report data on 
additional quality measures that are not reportable through their 
preferred method or be penalized for failing to report additional 
measures via a second submission mechanism and that CMS should only 
review the measures available to a clinician or group given their 
chosen submission mechanism--claims, registry, EHR or QCDR--to 
determine if they could have reported on additional measures. A few 
commenters recommended that CMS only offer multiple submission 
mechanisms as an option that could earn a clinician bonus points to 
recognize investment in an additional submission mechanism. One 
commenter

[[Page 53624]]

recommended that reporting using more than one submission mechanism be 
required for a given performance period only if the MIPS eligible 
clinician or group already has an additional submission mechanism in 
place that could be utilized to submit additional measures.
    Response: We are not requiring that MIPS individual clinicians and 
groups submit via additional submission mechanisms; however, through 
this proposal the option would be available for those that have 
applicable measures and/or activities available to them. As discussed 
in section II.C.7.a.(2)(e) of this final rule with comment period, 
beginning with the CY 2019 performance period, we will apply our 
validation process to determine if other measures are available and 
applicable only with respect to the data submission mechanism(s) that a 
MIPS eligible clinician utilizes for the quality performance category 
for a performance period. With regard to a specialty measure set, 
specialists who report on a speciality measure set are only required to 
report on the measures within that set, even if it is less than the 
required 6 measures. If the specialty set includes measures that are 
available through multiple submission mechanisms, then through this 
policy, beginning with the 2019 performance period, the option to 
report additional measures would be available for those that have 
applicable measures and/or activities available to them, which may 
potentially increase their score, but they are not required to utilize 
multiple submission methods to meet the 6 measure requirement. In 
addition, for MIPS eligible clinicians reporting on a specialty measure 
set via claims or registry, we will apply our validation process to 
determine if other measures are available and applicable within the 
specialty measure set only with respect to the data submission 
mechanism(s) that a MIPS eligible clinician utilizes for the quality 
performance category for a performance period.
    Comment: Many commenters did not support our proposal to allow 
submission of measures via multiple submission mechanisms or expressed 
concerns with the proposal. Several commenters expressed concern that 
it would add burden, confusion, and complexity for MIPS eligible 
clinicians and groups, as well as vendors, possibly requiring them to 
track measures across mechanisms based on varying benchmarks and to 
review measures and tools to determine if there are additional 
applicable measures.
    Response: We understand the commenters concerns with regards to 
burden and complexity around the use of multiple submission mechanisms. 
we are not requiring that MIPS individual clinicians and groups submit 
via additional submission mechanisms; however, through this proposal 
the option would be available for those that have applicable measures 
and/or activities available to them. As discussed in section 
II.C.7.a.(2)(e) of this final rule with comment period, beginning with 
the CY 2019 performance period, we will apply our validation process to 
determine if other measures are available and applicable only with 
respect to the data submission mechanism(s) that a MIPS eligible 
clinician utilizes for the quality performance category for a 
performance period. With regard to a specialty measure set, specialists 
who report on a speciality measure set are only required to report on 
the measures within that set, even if it is less than the required 6 
measures. If the specialty set includes measures that are available 
through multiple submission mechanisms, then through this policy, 
beginning with the 2019 performance period, the option to report 
additional measures would be available for those that have applicable 
measures and/or activities available to them, which may potentially 
increase their score, but they are not required to utilize multiple 
submission methods to meet the 6 measure requirement. In addition, for 
MIPS eligible clinicians reporting on a specialty measure set via 
claims or registry, we will apply our validation process to determine 
if other measures are available and applicable within the specialty 
measure set only with respect to the data submission mechanism(s) that 
a MIPS eligible clinician utilizes for the quality performance category 
for a performance period.
    Comment: A few commenters expressed concern that this policy could 
substantially increase costs and burden for MIPS eligible clinicians, 
as it may require a MIPS eligible clinician or group practice to 
purchase an additional data submission mechanism in order to report 6 
measures, and another commenter expressed concern for financial impact 
on small and solo practices. A few commenters stated that it would 
increase costs to vendors, which would be passed on to customers and 
patients. One commenter expressed concern regarding decreased 
productivity, and increased opportunity for coding errors. A few 
commenters expressed concern that they may be required to report on 
measures that are potentially not clinically relevant. One commenter 
noted that requiring the clinician to use multiple submission 
mechanisms would penalize them for something out of their control, 
specifically development of specialty-specific eCQMs, noting that even 
with software certified to all 64 eCQMs, fewer than 6 have a positive 
denominator. A few commenters expressed concern with how this proposal 
would interact with the measure validation process to determine whether 
a clinician could have reported additional measures, specifically 
expressing concern that it would require eligible clinicians to look 
across multiple mechanisms to fulfill the 6-measure requirement and 
that MIPS eligible clinicians should not be held accountable to meet 
more measures or look across submission mechanisms, and potentially 
invest in multiple mechanisms, because CMS is making additional 
submission mechanisms available.
    Response: We are not requiring that MIPS individual clinicians and 
groups submit via additional submission mechanisms; however, through 
this proposal the option would be available for those that have 
applicable measures and/or activities available to them. As discussed 
in section II.C.7.a.(2)(e) of this final rule with comment period, 
beginning with the CY 2019 performance period, we will apply our 
validation process to determine if other measures are available and 
applicable only with respect to the data submission mechanism(s) that a 
MIPS eligible clinician utilizes for the quality performance category 
for a performance period. With regard to a specialty measure set, 
specialists who report on a speciality measure set are only required to 
report on the measures within that set, even if it is less than the 
required 6 measures. If the specialty set includes measures that are 
available through multiple submission mechanisms, then through this 
policy, beginning with the 2019 performance period, the option to 
report additional measures would be available for those that have 
applicable measures and/or activities available to them, which may 
potentially increase their score, but they are not required to utilize 
multiple submission methods to meet the 6 measure requirement. In 
addition, for MIPS eligible clinicians reporting on a specialty measure 
set via claims or registry, we will apply our validation process to 
determine if other measures are available and applicable within the 
specialty measure set only with respect to the data submission 
mechanism(s) that a MIPS eligible clinician utilizes for the quality

[[Page 53625]]

performance category for a performance period.
    Comment: One commenter recommended that CMS withhold the option for 
submission through multiple mechanisms in the quality category for 
future implementation, or until CMS has become comfortable with the 
data received in year 1 of the program.
    Response: We agree with the commenter and due to operational 
feasibility concerns, we have determined that this proposal will be 
implemented beginning with the CY 2019 performance period. By the time 
this proposal is implemented for the CY 2019 performance period, we 
will have greater familiarity with which the way data is submitted to 
CMS based off submissions from the CY 2017 performance period.
    Comment: One commenter asked that CMS confirm that a MIPS eligible 
clinician would be allowed to submit data using multiple QCDRs under 
the same TIN/NPI or TIN because allowing submission via multiple QCDRs 
in single TIN could serve as a pathway forward for greater specialist 
participation within multispecialty groups.
    Response: A MIPS individual eligible clinician or group would be 
able to submit data using multiple QCDRs if they are able to find 
measures supported by other QCDRs that would provide meaningful 
measurement for the clinicians, and those measures are applicable. 
Consistent with the policy finalized in the CY 2017 Quality Payment 
Program final rule (81 FR 77282 through 77301), we would like to 
clarify that beginning with the CY 2019 performance period, if a MIPS 
eligible clinician or group reports for the quality performance 
category by using multiple instances of the same submission mechanism 
(for example, multiple QCDRs), then all the submissions would be 
scored, and the 6 quality measures with the highest performance (that 
is, the greatest number of measure achievement points) would be 
utilized for the quality performance category score. As noted above, if 
an individual MIPS eligible clinician or group submits the same measure 
through two different submission mechanisms, each submission would be 
calculated and scored separately. We do not have the ability to 
aggregate data on the same measure across submission mechanisms. 
Similarly, data completeness cannot be combined for the same measure 
that is reported through multiple submission mechanisms, but data 
completeness would need to be achieved for each measure and associated 
submission mechanism.
    Comment: One commenter requested clarification on how the data 
completeness will be determined if reporting the same quality measures 
via multiple submission mechanisms, for example, if a clinician 
utilized two submission mechanisms to report the same measure, would 50 
percent data completeness need to be achieved for each submission 
mechanism or for the combined data submitted. Another commenter asked 
how CMS will take into consideration data that is submitted using the 
same submission mechanism, but using two different products or 
services, specifically data submitted from two different certified EHRs 
in a single performance period when clinicians switch EHRs mid-
performance year.
    Response: In the CY 2017 Quality Payment Program final rule, we 
finalized that for the quality performance category, an individual MIPS 
eligible clinician or group that submits data on quality measures via 
EHR, QCDR, qualified registry, claims, or a CMS-approved survey vendor 
for the CAHPS for MIPS survey will be assigned measure achievement 
points for 6 measures (1 outcome, or if an outcome measure is not 
available, another high priority measure and the next 5 highest scoring 
measures) as available and applicable, and we will receive applicable 
measure bonus points for all measures submitted that meet the bonus 
criteria (81 FR 77282 through 77301). Consistent with this policy, we 
would like to clarify that for performance periods beginning in 2019, 
if a MIPS eligible clinician or group reports for the quality 
performance category by using multiple instances of the same data 
submission mechanism (for example, multiple EHRs) then all the 
submissions would be scored, and the 6 quality measures with the 
highest performance (that is, the greatest number of measure 
achievement points) would be utilized for the quality performance 
category score. As noted above, if an individual MIPS eligible 
clinician or group submits the same measure through two different 
mechanisms, each submission would be calculated and scored separately. 
We do not have the ability to aggregate data on the same measure across 
multiple submission mechanisms. We would only count the submission that 
gives the clinician the higher score, thereby avoiding the double 
count. For example, if a MIPS eligible clinician submits performance 
data for Quality Measure 236, Controlling High Blood Pressure, using a 
registry and also through an EHR, these two submissions would be scored 
separately, and we would apply the submission with the higher score 
towards the quality performance score; we would not aggregated the 
score of the registry and EHR submission of the same measure. This 
approach decreases the likelihood of cumulative overcounting in the 
event that the submissions may have time or patient overlaps that may 
not be readily identifiable.
    Final Action: After consideration of the public comments received, 
we are finalizing our proposal at Sec.  414.1325(d) with modification. 
Specifically, due to operational reasons, and to allow for additional 
time to communicate how this policy intersects with out measure 
applicability policies, we are not finalizing this policy for the CY 
2019 performance period. For the CY 2018 performance period, we intend 
to continue implementing the submission mechanisms policies as 
finalized in the CY 2017 Quality Payment Program final rule (81 FR 
77094) that individual MIPS eligible clinicians and groups may elect to 
submit information via multiple submission mechanisms; however, they 
must use one submission mechanism per performance category. We are, 
however, finalizing our proposal beginning with the CY 2019 performance 
period. Thus, for purposes of the 2021 MIPS payment year and future 
years, beginning with performance periods occurring in 2019, individual 
MIPS eligible clinicians, groups, and virtual groups may submit data on 
measures and activities, as applicable, via multiple data submission 
mechanisms for a single performance category (specifically, the 
quality, improvement activities, or advancing care information 
performance category). Individual MIPS eligible clinicians and groups 
that have fewer than the required number of measures and activities 
applicable and available under one submission mechanism may submit data 
on additional measures and activities via one or more additional 
submission mechanisms, as necessary, provided that such measures and 
activities are applicable and available to them.
    We are finalizing our proposal with modification. Specifically, we 
are not finalizing our proposal for the CY 2018 performance period, and 
our previously finalized policies continue to apply for the CY 2018 
performance period. Thus, for the CY 2018 performance period, virtual 
groups may elect to submit information via multiple submission 
mechanisms; however, they must use the same identifier for all practice 
categories, and they may only use one submission mechanism per 
performance

[[Page 53626]]

category. We are, however, finalizing our proposal beginning with the 
CY 2019 performance period. Thus, beginning with the CY 2019 
performance period, virtual groups will be able to use multiple 
submission mechanisms for each performance category.
(2) Submission Deadlines
    In the CY 2017 Quality Payment Program final rule (81 FR 77097), we 
finalized submission deadlines by which all associated data for all 
performance categories must be submitted for the submission mechanisms 
described in this rule.
    As specified at Sec.  414.1325(f)(1), the data submission deadline 
for the qualified registry, QCDR, EHR, and attestation submission 
mechanisms is 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 
performance periods occurring in 2018, the data submission period will 
occur prior to January 2, 2019, if technically feasible, through March 
31, 2019. 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, 2019.
    At Sec.  414.1325(f)(2), we specified that for the Medicare Part B 
claims submission mechanism, data must be submitted on claims with 
dates of service during the performance period that must be processed 
no later than 60 days following the close of the performance period. 
Lastly, for the CMS Web Interface submission mechanism, at Sec.  
414.1325(f)(3), we specified that the data must be submitted during an 
8-week period following the close of the performance period that will 
begin no earlier than January 2, 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 did not propose any changes to the submission deadlines in the CY 
2018 Quality Payment Program proposed rule.
b. Quality Performance Criteria
(1) Background
    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.
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77098 through 77099), we finalized 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 comments we 
received in response to the CY 2017 Quality Payment Program proposed 
rule and the MIPS and APMs RFI.
     To encourage meaningful measurement, we finalized allowing 
individual MIPS eligible clinicians and groups the flexibility to 
determine the most meaningful measures and data submission mechanisms 
for their practice.
     To simplify the reporting criteria, we aligned the 
submission criteria for several of the data submission mechanisms.
     To reduce administrative burden and focus on measures that 
matter, we lowered the required number of the measures for several of 
the data submission mechanisms, yet still required that certain types 
of measures, particularly outcome measures, be reported.
     To create alignment with other payers and reduce burden on 
MIPS eligible clinicians, we incorporated measures that align with 
other national payers.
     To create a more comprehensive picture of a practice's 
performance, we also finalized the use of all-payer data where 
possible.
    As beneficiary health is always our top priority, we finalized 
criteria to continue encouraging the reporting of certain measures such 
as outcome, appropriate use, patient safety, efficiency, care 
coordination, or patient experience measures. However, as discussed in 
the CY 2017 Quality Payment Program final rule (81 FR 77098), we 
removed the requirement for measures to span across multiple domains of 
the NQS. While we do not require that MIPS eligible clinicians select 
measures across multiple domains, we encourage them to do so.
(2) Contribution to Final Score
    For MIPS payment year 2019, the quality performance category will 
account for 60 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 that 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 final score shall be based on 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 the cost performance 
category.
    In the CY 2017 Quality Payment Program final rule (81 FR 77100), we 
finalized at Sec.  414.1330(b) that, for MIPS payment years 2019 and 
2020, 60 percent and 50 percent, respectively, of

[[Page 53627]]

the MIPS final score will be based on the quality performance category. 
For the third and future years, 30 percent of the MIPS final score will 
be based on the quality performance category.
    As discussed in section II.C.6.d. of this final rule with comment 
period, we are not finalizing our proposal to weight the cost 
performance category at zero percent for the second MIPS payment year 
(2020) and are instead retaining the previously finalized cost 
performance category weight of 10 percent for that year. In accordance 
with section 1848(q)(5)(E)(i)(I)(bb) of the Act, for the first 2 years, 
the percentage of the MIPS final score that would otherwise be based on 
the quality performance category (that is, 30 percent) must be 
increased by the same number of percentage points by which the 
percentage based on the cost performance category is less than 30 
percent. We proposed to modify Sec.  414.1330(b)(2) to reweight the 
percentage of the MIPS final score based on the quality performance 
category for MIPS payment year 2020 as may be necessary to account for 
any reweighting of the cost performance category, if finalized (82 FR 
30037). Thus, since we are not finalizing our proposal to reweight the 
cost performance category to zero percent for MIPS payment year 2020, 
we are not finalizing our proposal to modify Sec.  414.1330(b)(2), as 
the performance in the quality performance category currently comprises 
50 percent of a MIPS eligible clinician's final score for MIPS payment 
year 2020, and no reweighting is necessary to account for the 
previously finalized cost performance category weight. We refer readers 
to section II.C.6.d. of this final rule with comment period for more 
information on the cost 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 finalized scoring 
policies, an individual MIPS eligible clinician or group that reports 
on all required measures and activities could potentially obtain the 
highest score possible within the performance category, assuming they 
perform well on the measures and activities they report. An individual 
MIPS eligible clinician or group who does not submit data on a required 
measure or activity would receive a zero score for the unreported items 
in the performance category (in accordance with section 
1848(q)(5)(B)(i) of the Act). The individual 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 
individual MIPS eligible clinician or group from obtaining the highest 
possible score within the performance category.
    The following is a summary of the public comments received on the 
``Contribution to Final Score'' proposal and our responses:
    Comment: Many commenters supported the policy to weight the quality 
performance category at 60 percent of the final score for the 2020 MIPS 
payment year. One commenter expressed appreciation for the proposal 
because it maintains consistency within the program, which facilitates 
easier implementation for upcoming years.
    Response: We appreciate the commenters' support. However, as noted 
above, we are not finalizing our proposal at Sec.  414.1330(b)(2) to 
provide that performance in the quality performance category will 
comprise 60 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2020. We believe that by keeping our current policy to 
weight the quality performance period at 50 percent and the cost 
performance category at 10 percent will help ease the transition so 
that MIPS eligible clinicians can understand how they will be scored in 
future years under MIPS generally and the cost performance category in 
particular, as the cost performance category will be weighted at 30 
percent beginning with MIPS payment year 2021.
    Comment: One commenter did not support the policy to weight the 
quality performance category at 60 percent of the final score for the 
2020 MIPS payment year. Instead, the commenter recommended that CMS 
retain the previously finalized weighting for the quality performance 
category of 50 percent for the 2020 MIPS payment year. The commenter 
explained that since the 2021 MIPS payment year will require a cost 
performance category weighting of 30 percent, they recommended that CMS 
not retreat from progressing toward that amount in the intervening 
year.
    Response: We appreciate the commenter's recommendation and note 
that we are not finalizing the cost performance category weighting at 
zero percent toward the final score for the 2020 MIPS payment year. 
Further, the percentage of the MIPS final score based on the quality 
performance category for MIPS payment year 2020 will be 50 percent in 
accordance with section 1848(q)(5)(E)(i)(I)(bb) of the Act. We refer 
readers to section II.C.6.d. of this final rule with comment period for 
more information on the cost performance category.
    Comment: One commenter requested clarification on the policy to 
weight the quality performance category at 60 percent of the final 
score for the 2020 MIPS payment year instead of 50 percent. The 
commenter requested clarification as to which performance category the 
10 percent difference would apply if the quality performance category 
was weighted at 50 percent in the 2020 MIPS payment year.
    Response: As previously noted in this final rule with comment 
period, for the 2020 MIPS payment year, the quality performance 
category will be weighted at 50 percent. The 10 percent difference will 
be applied to the cost performance category.
    Comment: A few commenters urged CMS to reconsider the proposal to 
weight the quality performance category at 60 percent of the final 
score for the 2020 MIPS payment year for non-patient facing MIPS 
eligible clinicians. One commenter noted that the quality performance 
category accounts for 85 percent of the total score for pathologists, 
and placing this much weight on the quality performance category puts 
pathologists at an unfair disadvantage given the lack of reportable 
measures. The commenter recommended that the improvement activity 
performance category be weighted more heavily at a 50 percent weight 
and that the quality performance category receive a 50 percent weight. 
Another commenter indicated that it was not possible for non-patient 
facing MIPS eligible clinicians to achieve a score higher than 40 
percent, in the quality performance category, given a lack of measures 
and given that those measures that are applicable are only worth 3 
points. While this score allows them to avoid a penalty, the commenter 
noted it precludes them from achieving a bonus. Thus, the commenter 
recommended that CMS reweight the quality performance category for non-
patient facing MIPS eligible clinicians so that they can receive a 
score of 70 percent or higher. This would give non-patient facing MIPS 
eligible clinicians motivation for improvement as well as encourage 
them to continue to participate in the Quality Payment Program should 
it become voluntary.
    Response: As previously noted in this final rule with comment 
period, we are not finalizing our proposal to reweight the quality 
performance to 60 percent of the final score or the cost performance 
category to zero percent of the final score for the 2020 MIPS payment 
year.

[[Page 53628]]

Therefore, we are keeping our previously finalized policy to weight the 
quality performance category at 50 percent and the cost performance 
category at 10 percent for the 2020 MIPS payment year. It is important 
to note that for the 2021 MIPS payment year that the quality 
performance category will be 30 percent of the final score, and the 
cost performance category will be 30 percent of the final score as 
required by statute. We cannot weight the improvement activities 
performance category more heavily as suggested because section 
1848(q)(5)(E)(i)(III) of the Act specifies that the improvement 
activities performance category will account for 15 percent of the 
final score and was codified as such at Sec.  414.1355. Regarding the 
comment on applicable measures being worth less points, we note that 
non-patient facing MIPS eligible clinicians may report on a specialty-
specific measure set (which may have fewer than the required six 
measures) or may report through a QCDR that can report QCDR measures in 
order to earn the full points in the quality performance category.
    Final Action: After consideration of the public comments, we are 
not finalizing our proposal at Sec.  414.1330(b)(2) to provide that 
performance in the quality performance category will comprise 60 
percent of a MIPS eligible clinician's final score for MIPS payment 
year 2020. Rather we will be maintaining our previously finalized 
policy at Sec.  414.1330(b)(2) to provide that the performance in the 
quality performance category will comprise 50 percent of a MIPS 
eligible clinician's final score for MIPS payment year 2020.
(3) Quality Data Submission Criteria
(a) Submission Criteria
(i) Submission Criteria for Quality Measures Excluding Groups Reporting 
via the CMS Web Interface and the CAHPS for MIPS Survey
    In the CY 2017 Quality Payment Program final rule (81 FR 77114), we 
finalized at Sec.  414.1335(a)(1) that individual MIPS eligible 
clinicians submitting data via claims and individual MIPS eligible 
clinicians and groups submitting data via all mechanisms (excluding the 
CMS Web Interface and the CAHPS for MIPS survey) are required to meet 
the following submission criteria. For the applicable period during the 
performance period, the individual 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 
individual 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 individual MIPS 
eligible clinician or group would be required to report on each measure 
that is applicable. We defined ``applicable'' to mean measures relevant 
to a particular MIPS eligible clinician's services or care rendered. As 
discussed in section II.C.7.a.(2) of this final rule with comment 
period, we will only make determinations as to whether a sufficient 
number of measures are applicable for claims-based and registry 
submission mechanisms; we will not make this determination for EHR and 
QCDR submission mechanisms, for example.
    Alternatively, the individual MIPS eligible clinician or group will 
report one specialty 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, the MIPS eligible clinician will 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 measure 
set and will not be penalized for doing so, provided that such MIPS 
eligible clinicians follow all requirements discussed here.
    In accordance with Sec.  414.1335(a)(1)(ii), individual MIPS 
eligible clinicians and groups will select their measures from either 
the set of all MIPS measures listed or referenced in Table A of the 
Appendix in this final rule with comment period or one of the specialty 
measure sets listed in Table B of the Appendix in this final rule with 
comment period. We note that some specialty measure sets include 
measures grouped by subspecialty; in these cases, the measure set is 
defined at the subspecialty level. Previously finalized quality 
measures may be found in the CY 2017 Quality Payment Program final rule 
(81 FR 77558 through 77816).
    We also finalized the definition of a high priority measure at 
Sec.  414.1305 to mean an outcome, appropriate use, patient safety, 
efficiency, patient experience, or care coordination quality measure. 
Except as discussed in section II.C.6.b.(3)(a) of this final rule with 
comment period with regard to the CMS Web Interface and the CAHPS for 
MIPS survey, we did not propose any changes to the submission criteria 
or definitions established for measures in the proposed rule.
    In the CY 2017 Quality Payment Program final rule (81 FR 77114), we 
solicited comments regarding adding a requirement to our finalized 
policy 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 the Quality 
Payment Program Year 2 and future years. For clarification, we consider 
a cross-cutting measure to be any measure that is broadly applicable 
across multiple clinical settings and individual MIPS eligible 
clinicians or groups within a variety of specialties. We specifically 
requested 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. We refer readers to the CY 2018 
Quality Payment Program proposed rule (82 FR 30038 through 30039) for a 
full discussion of the comments received and responses provided.
    Except as discussed in section II.C.6.b.(3)(a)(iii) of this final 
rule with comment period with regard to the CAHPS for MIPS survey, we 
did not propose any changes to the submission criteria for quality 
measures. We solicited additional feedback on meaningful ways to 
incorporate cross-cutting measurement into MIPS and the Quality Payment 
Program generally. We received several comments regarding incorporating 
cross-cutting measurements into the Quality Payment Program and will 
take them into consideration in future rulemaking.
(ii) Submission Criteria for Quality Measures for Groups Reporting via 
the CMS Web Interface
    In the CY 2017 Quality Payment Program final rule (81 FR 77116), we 
finalized at Sec.  414.1335(a)(2) the following criteria for the 
submission of data on quality measures by registered groups of 25 or 
more eligible clinicians

[[Page 53629]]

who want to report via the CMS Web Interface. For the applicable 12-
month performance period, 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 or measure. If the sample of 
eligible assigned beneficiaries is less than 248, then the group would 
report on 100 percent of assigned beneficiaries. A group would be 
required to report on at least one measure for which there is Medicare 
patient data. 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. Specifically, we proposed to revise Sec.  414.1335(a)(2) to 
clarify that the CMS Web Interface criteria applies only to groups of 
25 or more eligible clinicians (82 FR 30039). As previously finalized 
at Sec.  414.1335(a)(2)(i), groups using the CMS Web Interface must 
report on all measures included in the CMS Web Interface and report on 
the first 248 consecutively ranked beneficiaries in the sample for each 
measure or module.
    In the CY 2017 Quality Payment Program final rule (81 FR 77116), we 
finalized to continue to align the 2019 CMS Web Interface beneficiary 
assignment methodology with the attribution methodology for two of the 
measures that were formerly in the VM: the acute and chronic composite 
measures of Agency for Healthcare Research and Quality (AHRQ) 
Prevention Quality Indicators (PQIs) discussed in the CY 2017 Quality 
Payment Program proposed rule (81 FR 28192) and total per capita cost 
for all attributed beneficiaries discussed in the CY 2017 Quality 
Payment Program proposed rule (81 FR 28196). When establishing MIPS, we 
also finalized a modified 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 CY 2017 
Quality Payment Program proposed rule (81 FR 28196).
    We clarify that the attribution methodology for the CMS Web 
Interface implemented under MIPS is similar to the attribution 
methodology implemented under the Physician Quality Reporting System 
(PQRS) Group Practice Reporting Option (GPRO) Web Interface, which 
utilizes a two-step attribution process to associate beneficiaries with 
TINs during the period in which performance is assessed. The process 
attributes a beneficiary to a TIN that bills the plurality of primary 
care services for that beneficiary. In order to conduct attribution for 
the CMS Web Interface, we utilize retrospective assignment to identify 
beneficiaries eligible for sampling and identify the beneficiary claims 
that will be utilized for the calculations of cost. Beneficiary 
assignment for groups is based on a 10-month period (between January 
and October) and determined retrospectively after the month of October 
for the applicable performance period. We note that it is not 
operationally feasible for us to utilize a period longer than 10 
months, to assess claims data for beneficiary assignment for a 
performance period.
    Lastly, we note that groups reporting via the CMS Web Interface may 
also report the CAHPS for MIPS survey and receive bonus points for 
submitting that measure. We did not propose any changes to the 
submission criteria for quality measures for groups reporting via the 
CMS Web Interface in the proposed rule.
    The following is a summary of the public comments received on the 
``Submission Criteria for Quality Measures for Groups Reporting via the 
CMS Web Interface'' proposal and our responses:
    Comment: One commenter suggested that CMS allow groups with fewer 
than 25 eligible clinicians (such as 2 or more eligible clinicians in a 
group) to use CMS Web Interface reporting. The commenter was concerned 
that the Quality Payment Program is more limiting than PQRS with regard 
to available submission mechanisms.
    Response: The CMS Web Interface has been limited to groups of 25 or 
more eligible clinicians because smaller groups have not been able to 
meet the data submission requirements on the sample of the Medicare 
Part B patients we provide. We would like to clarify that we have made 
available the same submission mechanisms for the Quality Payment 
Program that were available for PQRS. In addition, we are finalizing 
our proposal to revise Sec.  414.1325(d) for purposes of the 2021 MIPS 
payment year and future years to allow individual MIPS eligible 
clinicians and groups to submit measures and activities, as applicable, 
via as many submission mechanisms as necessary to meet the requirements 
of the quality, improvement activities, or advancing care information 
performance categories. We refer readers to section II.C.6.a.(1) of 
this final rule with comment period for more information on submission 
mechanisms.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal at Sec.  414.1335(a)(2) to clarify that the CMS 
Web Interface criteria applies only to group of 25 or more eligible 
clinicians. As previously finalized at Sec.  414.1335(a)(2)(i), the 
group must report on the first 248 consecutively ranked beneficiaries 
in the sample for each measure or module.
(iii) Performance Criteria for Quality Measures for Groups Electing To 
Report Consumer Assessment of Healthcare Providers and Systems (CAHPS) 
for MIPS Survey
    In the CY 2017 Quality Payment Program final rule (81 FR 77100), we 
finalized 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 measure 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 mechanism. A group may report any five measures within 
MIPS plus the CAHPS for MIPS survey to achieve the six measures 
threshold. We did not propose any changes to the performance criteria 
for quality measures for groups electing to report the CAHPS for MIPS 
survey in the proposed rule.
    In the CY 2017 Quality Payment Program final rule (see 81 FR 
77120), we finalized retaining the CAHPS for MIPS survey administration 
period that was utilized for PQRS of November to February. However, 
this survey administration period has become operationally problematic 
for the administration of MIPS. In order to compute scoring, we must 
have the

[[Page 53630]]

CAHPS for MIPS survey data earlier than the current survey 
administration period deadline allows. Therefore, we proposed for the 
Quality Payment Program Year 2 and future years that the survey 
administration period would, at a minimum, span over 8 weeks and would 
end no later than February 28th following the applicable performance 
period (82 FR 30040). In addition, we proposed to further specify the 
start and end timeframes of the survey administration period through 
our normal communication channels.
    In addition, as discussed in the CY 2017 Quality Payment Program 
final rule (81 FR 77116), we anticipated exploring the possibility of 
updating the CAHPS for MIPS survey under MIPS, specifically not 
finalizing all of the proposed Summary Survey Measures (SSMs). The 
CAHPS for MIPS survey currently consists of the core CAHPS Clinician & 
Group (CG-CAHPS) Survey developed by the Agency for Healthcare Research 
and Quality (AHRQ), plus additional survey questions to meet CMS's 
program needs. We proposed for the Quality Payment Program Year 2 and 
future years to remove two SSMs, specifically, ``Helping You to Take 
Medication as Directed'' and ``Between Visit Communication'' from the 
CAHPS for MIPS survey (82 FR 30040). We proposed to remove the SSM 
entitled ``Helping You to Take Medication as Directed'' due to low 
reliability. In 2014 and 2015, the majority of groups had very low 
reliability on this SSM. Furthermore, based on analyses conducted of 
SSMs in an attempt to improve their reliability, removing questions 
from this SSM did not result in any improvements in reliability. The 
SSM, ``Helping You to Take Medication as Directed,'' has also never 
been a scored measure with the Medicare Shared Savings Program CAHPS 
for Accountable Care Organizations (ACOs) Survey. We refer readers to 
the CY 2014 Physician Fee Schedule final rule for a discussion on the 
CAHPS for ACOs survey scoring (79 FR 67909 through 67910) and measure 
tables (79 FR 67916 through 67917). The SSM entitled ``Between Visit 
Communication'' currently contains only one question. This question 
could also be considered related to other SSMs entitled: ``Care 
Coordination'' or ``Courteous and Helpful Office Staff,'' but does not 
directly overlap with any of the questions under that SSM. However, we 
proposed to remove this SSM in order to maintain consistency with the 
Medicare Shared Savings Program which, utilizes the CAHPS for ACOs 
Survey. The SSM entitled ``Between Visit Communication'' has never been 
a scored measure with the Medicare Shared Savings Program CAHPS for 
ACOs Survey. We refer readers to section II.C.6.g. for the discussion 
of the CAHPS for ACOs survey.
    In addition to public comments we received, we also took into 
consideration analysis we conducted before finalizing this provision. 
Specifically, we reviewed the findings of the CAHPS for ACOs survey 
pilot, which was administered from November 2016 through February 2017. 
The CAHPS for ACOs survey pilot utilized a survey instrument which did 
not contain the two SSMs that we proposed for removal from the CAHPS 
for MIPS survey. For more information on the other SSMs within 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).

 Table 4--Summary Survey Measures (SSMs) Included in the CAHPS for MIPS
                                 Survey
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Getting Timely Care, Appointments, and Information.
How Well Providers Communicate.
Patient's Rating of Provider.
Access to Specialists.
Health Promotion and Education.
Shared Decision-Making.
Health Status and Functional Status.
Courteous and Helpful Office Staff.
Care Coordination.
Stewardship of Patient Resources.
------------------------------------------------------------------------

    We sought comment on expanding the patient experience data 
available for the CAHPS for MIPS survey (82 FR 30040 through 30401). 
Currently, the CAHPS for MIPS survey is available for groups to report 
under the MIPS. The patient experience survey data that is available on 
Physician Compare is highly valued by patients and their caregivers as 
they evaluate their health care options. However, in user testing with 
patients and caregivers in regard to the Physician Compare Web site, 
the users regularly request more information from patients like them in 
their own words. Patients regularly request that we include narrative 
reviews of individual clinicians and groups on the Web site. AHRQ is 
fielding a beta version of the CAHPS Patient Narrative Elicitation 
Protocol (https://www.ahrq.gov/cahps/surveys-guidance/item-sets/elicitation/index.html). This includes five open-ended questions 
designed to be added to the CG CAHPS survey, after which the CAHPS for 
MIPS survey is modeled. These five questions have been developed and 
tested in order to capture patient narratives in a scientifically 
grounded and rigorous way, setting it apart from other patient 
narratives collected by various health systems and patient rating 
sites. More scientifically rigorous patient narrative data would not 
only greatly benefit patients in their decision for healthcare, but it 
would also greatly aid individual MIPS eligible clinicians and groups 
as they assess how their patients experience care. We sought comment on 
adding these five open-ended questions to the CAHPS for MIPS survey in 
future rulemaking. Beta testing is an ongoing process, and we 
anticipate reviewing the results of that testing in collaboration with 
AHRQ before proposing changes to the CAHPS for MIPS survey.
    We are requiring, where possible, all-payer data for all reporting 
mechanisms, yet certain reporting mechanisms are limited to Medicare 
Part B data. Specifically, the CAHPS for MIPS survey currently relies 
on sampling protocols based on Medicare Part B billing; therefore, only 
Medicare Part B beneficiaries are sampled through that methodology. We 
requested comments on ways to modify the methodology to assign and 
sample patients using data from other payers for reporting mechanisms 
that are currently limited to Medicare Part B data (82 FR 30041). In 
particular, we sought comment on the ability of groups to provide 
information on the patients to whom they provide care during a calendar 
year, whether it would be possible to identify a list of patients seen 
by individual clinicians in the group, and what type of patient contact 
information groups would be able to provide. Further, we sought comment 
on the challenges groups may anticipate in trying to provide this type 
of information, especially for vulnerable beneficiary populations, such 
as those lacking stable housing. We also sought comment on EHR vendors' 
ability to provide information on the patients who receive care from 
their client groups.
    The following is a summary of the public comments received on the 
``Performance Criteria for Quality Measures for Groups Electing to 
Report the CAHPS for MIPS Survey'' proposals and our responses:
    Comment: A few commenters supported removing the 2 SSMs, ``Helping 
You to Take Medication as Directed'' and ``Between Visit 
Communication'' from CAHPS for MIPS for the 2018 MIPS performance 
period and future MIPS performance periods. The commenters recommended 
that CMS communicate all changes made to the CAHPS for MIPS survey well 
in advance of the annual registration

[[Page 53631]]

deadline. While supportive of CMS' proposal to remove these 2 SSMs, one 
commenter urged CMS to replace the ``Helping You to Take Medication as 
Directed'' module with a reliable way to measure patient experience for 
patients as part of understanding their medications. Finally, one 
commenter urged CMS to make the survey even shorter, stating that it is 
still significantly too long to gain a large enough adoption rate among 
patients and needs to be reduced further to increase completion rates.
    Response: We thank the commenters for their support and will make 
every effort to continue to communicate changes to the CAHPS for MIPS 
survey. We also appreciate the commenters' suggestion to replace the 
``Helping You to Take Medication as Directed'' SSM with a reliable way 
to measure patients' understanding of their medications, as well as the 
suggestion to reduce the number of questions in the CAHPS for MIPS 
survey, and will consider these suggestions for future years of the 
CAHPS for MIPS survey. We are finalizing for the Quality Payment 
Program Year 2 and future years to remove two SSMs, specifically, 
``Helping You to Take Medication as Directed'' and ``Between Visit 
Communication'' from the CAHPS for MIPS survey.
    Comment: Several commenters did not support the proposal to remove 
the 2 SSMs without alternative domains or better patient experience or 
patient-reported outcomes measures to replace them and urged us to 
leave these SSMs in the survey at this time. Commenters noted that 
although the ``Between Visit Communication'' measure is related to 2 
other SSMs (``Care Coordination'' and ``Courteous and Helpful Office 
Staff''), these measures do not entirely overlap, and poor 
communication between visits can have serious consequences. The 
commenters also expressed concern that the ``Helping You to Take 
Medication as Directed'' SSM is needed to continue to capture safe and 
appropriate medication use as a domain of the CAHPS for MIPS survey. 
One commenter expressed concern that removal of the SSM is premature 
and encouraged us to improve this SSM instead of removing it entirely, 
urging us to retain the SSM and capture this information within both 
the CAHPS for MIPS and the CAHPS for ACOs surveys if necessary. Another 
commenter recommended that CMS keep the current CAHPS format which they 
noted provides important feedback on key areas such as timely 
appointments, easy access to information, and good communication with 
healthcare providers.
    Response: We acknowledge the commenters' concerns with respect to 
removing the ``Between Visit Communication'' and ``Helping You to Take 
Medication as Directed'' SSMs. We would like to note that the Shared 
Savings Program piloted tested a revised CAHPS survey that did not 
include these two SSMs, and we have reviewed the results of that 
survey. Results from the pilot study suggest that administration of the 
shortened version of the survey (that is, the pilot survey) is likely 
to result in improvements in overall response rates. Findings show that 
the response rate to the pilot survey was 3.4 percentage points higher 
than the response rate to the Reporting Year (RY) 2016 CAHPS for ACOs 
survey among ACOs participating in the pilot study. Increases in 
response rates tended to be larger among ACOs that had lower response 
rates in the prior year. In addition, after accounting for survey 
questions that were removed from the pilot survey, the average survey 
responses for ACOs who participated in the pilot study were mostly 
similar across the two survey versions (pilot and RY 2016). Based on 
results of the piloted CAHPS survey, we recommend the removal of the 
two SSMs ``Between Visit Communication'' and ``Helping You to Take 
Medications as Directed''. Further, the SSM, ``Between Visit 
Communication,'' currently contains only one question. This question 
could also be considered related to other SSMs entitled: ``Care 
Coordination'' or ``Courteous and Helpful Office Staff,'' but does not 
directly overlap with any of the questions under that SSM. As for the 
SSM, ``Helping You to Take Medication as Directed,'' this SSM has had 
low reliability. However, we will continue to look at ways to further 
improve the CAHPS for MIPS survey including exploring new questions and 
domains of patient experience. We are finalizing for the Quality 
Payment Program Year 2 and future years to remove two SSMs, 
specifically, ``Helping You to Take Medication as Directed'' and 
``Between Visit Communication'' from the CAHPS for MIPS survey.
    Comment: A few commenters supported the proposal to reduce the 
minimum fielding period for CAHPS for MIPS from 4 months to 2 months in 
the 2018 MIPS performance period to allow CMS to have adequate time to 
collect the data needed to administer the MIPS program. One commenter 
urged CMS to explore additional ways to improve the survey in terms of 
the survey administration time frame, frequency of results, and the 
length of the survey and its administration, which is often well after 
the patient's visit.
    Response: We plan to consider additional ways to improve the survey 
in regards to the timeframe for administering the survey, frequency of 
the results, as well as the survey instrument and its administration. 
We are finalizing that for the Quality Payment Program Year 2 and 
future years the survey administration period would span over a minimum 
of 8 weeks to a maximum of 17 weeks and would end no later than 
February 28th following the applicable performance period. In addition, 
we are finalizing to further specify the start and end timeframes of 
the survey administration period through our normal communication 
channels.
    Comment: A few commenters did not support the proposal to change 
the minimum fielding period for CAHPS for MIPS, expressing concern that 
2 months of data is inadequate for a meaningful assessment of the 
patient experience. One commenter expressed concern that the cost to 
engage a survey vendor for a relatively short period and for 
potentially low returns may limit the value of participation, 
especially if the cost is in addition to costs for the mechanisms to 
support the other 5 quality measures. Commenters encouraged CMS to 
field the CAHPS for MIPS survey for at least 10 to 14 weeks--or to 
select 12 weeks in alignment with existing CAHPS guidelines--in order 
to improve the patient response rate and avoid unintentionally 
excluding patients who have a more difficult time responding within the 
shortened response period.
    Response: We appreciate the commenters' concern that 2 months of 
data is inadequate for a meaningful assessment of patient experience 
and the recommendation to field the CAHPS for MIPS survey for at least 
10 to 14 weeks. We would like to clarify that the proposal was for the 
survey administration, at a minimum, to span over 8 weeks. We believe 
that an 8 week minimum is adequate for the meaningful assessment of the 
patient experience because it provides sufficient time for the 
beneficiaries to respond to the survey. With respect to the 2018 CAHPS 
for MIPS survey, we anticipate that the survey administration period 
will be longer than the minimum 8 weeks and note that we will specify 
the start and end timeframes of the survey administration period 
through our normal communication channels. Further, this policy will 
allow us the flexibility to adjust the survey administration period to 
meet future operational needs, as well

[[Page 53632]]

as any newly identified adjustments to the survey administration period 
that would result in improvements, such as response rates. We are 
finalizing that for the Quality Payment Program Year 2 and future years 
the survey administration period would, span over a minimum of 8 weeks 
to a maximum of 17 weeks and end no later than February 28th following 
the applicable performance period. We refer readers to section 
II.C.6.a. of this final rule with comment period for more information 
on submission mechanisms.
    Final Action: After consideration of the public comments, we are 
finalizing that for the Quality Payment Program Year 2 and future years 
the survey administration period would span over a minimum of 8 weeks 
to a maximum of 17 weeks and would end no later than February 28th 
following the applicable performance period. In addition, we are 
finalizing to further specify the start and end timeframes of the 
survey administration period through our normal communication channels. 
Further, we are finalizing for the Quality Payment Program Year 2 and 
future years to remove two SSMs, specifically, ``Helping You to Take 
Medication as Directed'' and ``Between Visit Communication'' from the 
CAHPS for MIPS survey.
(b) Data Completeness Criteria
    In the CY 2017 Quality Payment Program final rule (81 FR 77125), we 
finalized data completeness criteria for the transition year and MIPS 
payment year 2020. We finalized at Sec.  414.1340 the data completeness 
criteria that follows for performance periods occurring in 2017.
     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 individual 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 that CMS provides.
    In addition, we finalized an increased data completeness threshold 
of 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 noted that we anticipate we will 
propose to increase these thresholds for data submitted on quality 
measures using QCDRs, qualified registries, via EHR, or Medicare Part B 
claims for performance periods occurring in 2019 and onward.
    We proposed to modify the previously established data completeness 
criteria for MIPS payment year 2020 (82 FR 30041 through 30042). 
Specifically, we proposed to provide an additional year for individual 
MIPS eligible clinicians and groups to gain experience with MIPS before 
increasing the data completeness thresholds for data submitted on 
quality measures using QCDRs, qualified registries, via EHR, or 
Medicare Part B claims. We noted concerns about the unintended 
consequences of accelerating the data completeness threshold so 
quickly, which may jeopardize MIPS eligible clinicians' ability to 
participate and perform well under the MIPS, particularly those 
clinicians who are least experienced with MIPS quality measure data 
submission. We wanted to ensure that an appropriate yet achievable 
level of data completeness is applied to all MIPS eligible clinicians. 
We continue to believe it is important to incorporate higher data 
completeness thresholds in future years to ensure a more accurate 
assessment of a MIPS eligible clinician's performance on quality 
measures and to avoid any selection bias. Therefore, we proposed a 60 
percent data completeness threshold for MIPS payment year 2021. We 
strongly encouraged all MIPS eligible clinicians to perform the quality 
actions associated with the quality measures on their patients. The 
data submitted for each measure is expected to be representative of the 
individual MIPS eligible clinician's or group's overall performance for 
that measure. The data completeness threshold of less than 100 percent 
is intended to reduce burden and accommodate operational issues that 
may arise during data collection during the initial years of the 
program. We provided this notice to MIPS eligible clinicians so that 
they can take the necessary steps to prepare for higher data 
completeness thresholds in future years.
    Therefore, we proposed to revise the data completeness criteria for 
the quality performance category at Sec.  414.1340(a)(2) to provide 
that MIPS eligible clinicians and groups submitting quality measures 
data using the QCDR, qualified registry, or EHR submission mechanism 
must submit data on at least 50 percent of the individual MIPS eligible 
clinician's or group's patients that meet the measure's denominator 
criteria, regardless of payer, for MIPS payment year 2020. We also 
proposed to revise the data completeness criteria for the quality 
performance category at Sec.  414.1340(b)(2) to provide that MIPS 
eligible clinicians and groups submitting quality measures data using 
Medicare Part B claims, must submit data on at least 50 percent of the 
applicable Medicare Part B patients seen during the performance period 
to which the measure applies for MIPS payment year 2020. We further 
proposed at Sec.  414.1340(a)(3), that MIPS eligible clinicians and 
groups submitting quality measures data using the QCDR, qualified 
registry, or EHR submission mechanism must submit data on at least 60 
percent of the individual MIPS eligible clinician or group's patients 
that meet the measure's denominator criteria, regardless of payer, for 
MIPS payment year 2021. We also proposed at Sec.  414.1340(b)(3), that 
MIPS eligible clinicians and groups submitting quality measures data 
using Medicare Part B claims, must submit data on at least 60 percent 
of the applicable Medicare Part B patients seen during the performance 
period to which the measure applies for MIPS payment year 2021. We 
noted that we anticipate for future MIPS payment years we will propose 
to increase the data completeness threshold for data submitted using 
QCDRs, qualified registries, EHR submission mechanisms, or Medicare 
Part B claims. As MIPS eligible clinicians gain experience with the 
MIPS, we would propose to steadily increase these thresholds for future 
years through rulemaking. In addition, we sought comment on what data 
completeness threshold should be established for future years.
    In the CY 2017 Quality Payment Program final rule (81 FR 77125 
through 77126), we finalized our approach of including all-payer data 
for the QCDR, qualified registry, and EHR submission mechanisms because 
we believed this approach provides a more complete picture of each MIPS 
eligible clinician's

[[Page 53633]]

scope of practice and provides more access to data about specialties 
and subspecialties not currently captured in PQRS. In addition, those 
clinicians who utilize the QCDR, qualified registry, or EHR data 
submission methods must contain a minimum of one quality measure for at 
least one Medicare patient. We did not propose any changes to these 
policies. As noted in the CY 2017 Quality Payment Program final rule, 
those MIPS eligible clinicians who fall below the data completeness 
thresholds will receive 3 points for the specific measures that fall 
below the data completeness threshold in the transition year of MIPS 
only. For the Quality Payment Program Year 2, we proposed that MIPS 
eligible clinicians would receive 1 point for measures that fall below 
the data completeness threshold, with an exception for small practices, 
which would still receive 3 points for measures that fail data 
completeness. We refer readers to section II.C.6.b.(3) of this final 
rule with comment period for our finalized policies on instances when 
MIPS eligible clinicians' measures fall below the data completeness 
threshold.
    The following is a summary of the public comments received on the 
``Data Completeness Criteria'' proposals and our responses:
    Comment: Several commenters expressed support for our proposal to 
increase the data completeness threshold to 60 percent for the 2021 
MIPS payment year.
    Response: We appreciate the commenters' support and are finalizing 
this proposal.
    Comment: Several commenters urged CMS to not finalize an increase 
in the data completeness threshold for the 2021 MIPS payment year or 
future payment years. Commenters noted that constant changing in 
reporting requirements creates administrative challenges for eligible 
clinicians and their staff. Other commenters observed that a higher 
threshold of data completeness requires a significant amount of 
technical and administrative coordination which can take several months 
to properly validate, both for MIPS eligible clinicians in larger 
practices and those in small and rural practices.
    Response: We understand the commenters' concerns but believe it is 
important to incorporate higher thresholds to ensure a more accurate 
assessment of a MIPS eligible clinician's performance on the quality 
measures and to avoid any selection bias. Therefore, we are not 
finalizing our proposal to decrease the data completeness threshold to 
50 percent for the 2020 MIPS payment year and are instead retaining the 
previously finalized data completeness threshold of 60 percent that 
year. In addition, we are finalizing our proposal to increase the data 
completeness threshold to 60 percent for MIPS payment year 2021.
    Comment: Many commenters supported the proposal to apply the data 
completeness criteria that was previously finalized for the CY 2017 
performance period to the CY 2018 performance period because they 
believed that it would help create stability within the quality 
performance category, would enable MIPS eligible clinicians and groups 
to gain additional experience reporting on quality measures and make 
improvements, and would enhance the ability of MIPS eligible clinicians 
and groups to perform well in the program. Several commenters noted 
that taking a slower approach to increasing the data completeness 
criteria is the best way to ensure reliable and accurate data is 
submitted so that CMS has a complete and accurate reflection of MIPS 
eligible clinician performance.
    Response: While we understand the commenters' desire to take a more 
gradual approach, we must balance this with need to ensure that we have 
a complete an accurate reflection of MIPS eligible clinician 
performance. As such, we are not finalizing our proposal to decrease 
the data completeness threshold to 50 percent for the 2020 MIPS payment 
year and are instead retaining the previously finalized data 
completeness threshold of 60 percent for that year. In addition, we are 
finalizing our proposal to increase the data completeness threshold to 
60 percent for MIPS payment year 2021.
    Comment: A few commenters did not support our proposal to delay 
moving to a higher data completeness threshold until the 2019 MIPS 
performance period and 2021 MIPS payment year, expressing concern that 
a delay would encourage MIPS eligible clinicians and groups to avoid 
the selection of population-based measures that would more easily meet 
any higher completeness requirements that we might set; would 
negatively impact the ability of high performers to receive a 
substantial payment increase in the 2020 MIPS payment year; and would 
not prepare MIPS eligible clinicians and groups for a more rigorous 
program in future years. A few commenters suggested that 50 percent of 
available data is insufficient and that a larger patient sample 
provides a more reliable and valid representation of true performance 
and will better support clinician groups in internal benchmarking for 
quality improvement. One commenter noted that a delay would continue to 
create a misalignment between the MIPS and Advanced APM tracks. One 
commenter disagreed with the 50 percent threshold itself, expressing 
concern that this standard may motivate MIPS eligible clinicians and 
groups to ``cherry pick'' the cases that make up the denominator for 
reporting. This commenter suggested that for any reporting mechanism 
for which a MIPS eligible clinician could attest to a formal, auditable 
representative sampling, we should exempt the MIPS eligible clinician 
from the data completeness standard.
    Response: We agree that a larger sample reduces the likelihood of 
selection bias and provides a more reliable and valid representation of 
true performance. As a result, we are not finalizing our proposal to 
decrease the data completeness threshold to 50 percent for the 2020 
MIPS payment year and are instead retaining the previously finalized 
data completeness threshold of 60 percent for that year. In addition, 
we are finalizing our proposal to increase the data completeness 
threshold to 60 percent for MIPS payment year 2021.
    Final Action: After consideration of the public comments, we are 
not finalizing our proposal regarding the data completeness criteria 
for MIPS payment year 2020. Instead, we are retaining our previously 
finalized requirements at:
     Sec.  414.1340(a)(2) that MIPS eligible clinicians and 
groups submitting quality measures data using the QCDR, qualified 
registry, or EHR submission mechanism must submit data on at least 60 
percent of the MIPS eligible clinician or group's patients that meet 
the measure's denominator criteria, regardless of payer for MIPS 
payment year 2020; and
     Sec.  414.1340(b)(2) that MIPS eligible clinicians 
submitting quality measures data using Medicare Part B claims, must 
submit data on at least 60 percent of the applicable Medicare Part B 
patients seen during the performance period to which the measure 
applies for MIPS payment years 2020.
    We are, however, finalizing our proposal regarding the data 
completeness criteria for MIPS payment year 2021. Specifically, we are 
finalizing at:
     Sec.  414.1340(a)(2) that MIPS eligible clinicians and 
groups submitting quality measures data using the QCDR, qualified 
registry, or EHR submission mechanism must submit data on at least 60 
percent of the MIPS eligible clinician or group's patients that meet 
the measure's denominator criteria,

[[Page 53634]]

regardless of payer for MIPS payment year 2021; and
     Sec.  414.1340(b)(2) that MIPS eligible clinicians 
submitting quality measures data using Medicare Part B claims, must 
submit data on at least 60 percent of the applicable Medicare Part B 
patients seen during the performance period to which the measure 
applies for MIPS payment years 2021.
(c) Summary of Data Submission Criteria
    Table 5 reflects our final quality data submission criteria for 
MIPS payment years 2020 and 2021 via Medicare Part B claims, QCDR, 
qualified registry, EHR, CMS Web Interface, and the CAHPS for MIPS 
survey. It is important to note that while we finalized at Sec.  
414.1325(d) in the CY 2017 Quality Payment Program final rule that 
individual MIPS eligible clinicians and groups may only use one 
submission mechanism per performance category, in section II.C.6.a.(1) 
of this final rule with comment period, we are finalizing to revise 
Sec.  414.1325(d) for purposes of the 2021 MIPS payment year and future 
years to allow individual MIPS eligible clinicians and groups to submit 
measures and activities, as applicable, via as many submission 
mechanisms as necessary to meet the requirements of the quality, 
improvement activities, or advancing care information performance 
categories. We refer readers to section II.C.6.a.(1) of this final rule 
with comment period for further discussion of this policy.

    TABLE 5--Summary of Final Quality Data Submission Criteria for MIPS Payment Year 2020 and 2021 via Part B
             Claims, QCDR, Qualified Registry, EHR, CMS Web Interface, and the CAHPS for MIPS Survey
----------------------------------------------------------------------------------------------------------------
                                                   Submission
   Performance period       Clinician type         mechanism          Submission criteria     Data completeness
----------------------------------------------------------------------------------------------------------------
Jan 1-Dec 31...........  Individual MIPS      Part B Claims......  Report at least six       60 percent of
                          eligible                                  measures including one    individual MIPS
                          clinicians.                               outcome measure, or if    eligible
                                                                    an outcome measure is     clinician's
                                                                    not available report      Medicare Part B
                                                                    another high priority     patients for the
                                                                    measure; if less than     performance
                                                                    six measures apply then   period.
                                                                    report on each measure
                                                                    that is applicable.
                                                                    Individual MIPS
                                                                    eligible clinicians
                                                                    would have to select
                                                                    their measures from
                                                                    either the set of all
                                                                    MIPS measures listed or
                                                                    referenced, or one of
                                                                    the specialty measure
                                                                    sets listed in, the
                                                                    applicable final rule.
Jan 1-Dec 31...........  Individual MIPS      QCDR, Qualified      Report at least six       60 percent of
                          eligible             Registry, & EHR.     measures including one    individual MIPS
                          clinicians, groups.                       outcome measure, or if    eligible
                                                                    an outcome measure is     clinician's, or
                                                                    not available report      group's patients
                                                                    another high priority     across all payers
                                                                    measure; if less than     for the
                                                                    six measures apply then   performance
                                                                    report on each measure    period.
                                                                    that is applicable.
                                                                    Individual MIPS
                                                                    eligible clinicians, or
                                                                    groups would have to
                                                                    select their measures
                                                                    from either the set of
                                                                    all MIPS measures
                                                                    listed or referenced,
                                                                    or one of the specialty
                                                                    measure sets listed in,
                                                                    the applicable final
                                                                    rule.
Jan 1-Dec 31...........  Groups.............  CMS Web Interface..  Report on all measures    Sampling
                                                                    included in the CMS Web   requirements for
                                                                    Interface; AND populate   the group's
                                                                    data fields for the       Medicare Part B
                                                                    first 248 consecutively   patients.
                                                                    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 need to be   requirements for
                                                                    paired with another       the group's
                                                                    reporting mechanism to    Medicare Part B
                                                                    ensure the minimum        patients.
                                                                    number of measures is
                                                                    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 would only
                                                                    count for one measure
                                                                    under the quality
                                                                    performance category.
----------------------------------------------------------------------------------------------------------------

    We note that the measure reporting requirements applicable to 
groups are also generally applicable to virtual groups. However, we 
note that the requirements for calculating measures and activities when 
reporting via QCDRs, qualified registries, EHRs, and attestation differ 
in their application to virtual groups. Specifically, these 
requirements apply cumulatively across all TINs in a virtual group. 
Thus, virtual groups will aggregate data for each NPI under each TIN 
within the virtual group by adding together the numerators and 
denominators and then cumulatively collate to report one measure ratio 
at the virtual group level. Moreover, if each MIPS eligible clinician 
within a virtual group faces a significant hardship or has EHR 
technology that has been decertified, the virtual group can apply for 
an exception to have its advancing care information performance 
category reweighted. If such exception application is approved, the 
virtual group's advancing care information performance category is 
reweighted to zero percent and applied to the quality performance 
category increasing the quality performance weight from 50 percent to 
75 percent.
    Additionally, the data submission criteria applicable to groups are 
also generally applicable to virtual groups. However, we note that data 
completeness and sampling requirements for the CMS Web Interface and 
CAHPS for MIPS survey differ in their application to virtual groups. 
Specifically, data completeness for virtual groups applies cumulatively 
across all TINs in a virtual group. Thus, we note that there may be a 
case when a virtual group has one TIN that falls below the 60 percent 
data completeness threshold, which is an acceptable case as long as the 
virtual group cumulatively exceeds such threshold. In regard to the CMS 
Web Interface and CAHPS for MIPS survey, sampling requirements pertain 
to Medicare Part B patients with respect to all TINs in a virtual 
group, where the sampling methodology would be conducted for

[[Page 53635]]

each TIN within the virtual group and then cumulatively aggregated 
across the virtual group. A virtual group would need to meet the 
beneficiary sampling threshold cumulatively as a virtual group.
(4) Application of Quality Measures to Non-Patient Facing MIPS Eligible 
Clinicians
    In the CY 2017 Quality Payment Program final rule (81 FR 77127), we 
finalized at Sec.  414.1335 that non-patient facing MIPS eligible 
clinicians would be required to meet the applicable submission criteria 
that apply for all MIPS eligible clinicians for the quality performance 
category. We did not propose any changes to this policy in the proposed 
rule.
(5) Application of Facility-Based 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. However, the Secretary may not 
use measures for hospital outpatient departments, except in the case of 
items and services furnished by emergency physicians, radiologists, and 
anesthesiologists. We refer readers to section II.C.7.a.(4) of this 
final rule with comment period for a full discussion of the finalized 
policies regarding the application of facility-based measures.
(6) Global and Population-Based Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77136), we 
did not finalize all of our proposals on global and population-based 
measures as part of the quality score. Specifically, we did not 
finalize our proposal to use the acute and chronic composite measures 
of the AHRQ Prevention Quality Indicators (PQIs). We agreed with 
commenters that additional enhancements, including the addition of risk 
adjustment, needed to be made to these measures prior to inclusion in 
MIPS. We did, however, calculate these measures at the TIN level, and 
provided the measure data through the QRURs released in September 2016, 
and this data can be used by MIPS eligible clinicians for informational 
purposes.
    We did finalize the all-cause hospital readmissions (ACR) measure 
from the VM Program as part of the annual list of quality measures for 
the MIPS quality performance category. We finalized this measure with 
the following modifications. We did not apply the ACR measure to solo 
practices or small groups (groups of 15 or less). We did apply the ACR 
measure to groups of 16 or more who meet the case volume of 200 cases. 
A group will be scored on the ACR measure even if it did not submit any 
quality measures, if it submitted in other performance categories. 
Otherwise, the group will not be scored on the readmission measure if 
it did not submit data in any of the performance categories. 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, an individual 
MIPS eligible clinician or group must submit information in one of the 
three performance categories as discussed in the CY 2017 Quality 
Payment Program final rule (81 FR 77329). However, for MIPS eligible 
clinicians who did not meet the minimum case requirements, the ACR 
measure was not applicable. In the CY 2018 Quality Payment Program 
proposed rule, we did not propose to remove this measure from the list 
of quality measures for the MIPS quality performance category. Nor did 
we propose any changes for the ACR measure in the proposed rule. As 
discussed in section II.C.4.d. of this final rule with comment period, 
we are finalizing our proposal to generally apply our finalized group 
policies to virtual groups.
c. Selection of MIPS Quality Measures for Individual MIPS Eligible 
Clinicians and Groups Under the Annual List of Quality Measures 
Available for MIPS Assessment
(1) Background and Policies for the Call for Measures and Measure 
Selection Process
    Under section 1848(q)(2)(D)(i) of the Act, the Secretary, through 
notice and comment rulemaking, must establish an annual list of MIPS 
quality measures from which MIPS eligible clinicians may choose for 
purposes of assessment for a performance period. The annual list of 
MIPS 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 MIPS quality measures 
must be published in the Federal Register no later than November 1 of 
the year prior to the first day of each subsequent performance period. 
Updates may include the addition of new MIPS quality measures, 
substantive changes to MIPS quality measures, and removal of MIPS 
quality measures. We refer readers to the CY 2018 Quality Payment 
Program proposed rule (82 FR 30043 and 30044) for additional 
information regarding eCQM reporting and the Measure Development Plan 
that serves as a strategic framework for the future of the clinician 
quality measure development to support MIPS and APMs. We encourage 
stakeholders to develop additional quality measures for MIPS that would 
address the gaps.
    Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must 
solicit a ``Call for Quality Measures Under Consideration'' each year. 
Specifically, the Secretary must request that eligible clinician 
organizations and other relevant stakeholders identify and submit 
quality measures to be considered for selection in the annual list of 
MIPS quality measures, as well as updates to the measures. Under 
section 1848(q)(2)(D)(ii) of the Act, eligible clinician organizations 
are professional organizations as defined by nationally recognized 
specialty boards of certification or equivalent certification boards. 
However, we do not believe there needs to be any special restrictions 
on the type or make-up of the organizations that submit measures for 
consideration through the call for measures. Any such restriction would 
limit the type of quality measures and the scope and utility of the 
quality measures that may be considered for inclusion under the MIPS.
    As we described previously in the CY 2017 Quality Payment Program 
final rule (81 FR 77137), we will accept quality measures submissions 
at any time, but only measures submitted during the timeframe provided 
by us through the pre-rulemaking process of each year will be 
considered for inclusion in the annual list of MIPS quality measures 
for the performance period beginning 2 years after the measure is 
submitted. This process is consistent with the pre-rulemaking process 
and the annual call for measures, which are further described at 
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rule-Making.html).
    Submission of potential quality measures, regardless of whether 
they were previously published in a proposed rule or endorsed by an 
entity with a contract under section 1890(a) of the Act, which is 
currently the National Quality Forum, is encouraged. 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

[[Page 53636]]

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 measures 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.
    As previously noted, we encourage the submission of potential 
quality measures regardless of whether such measures were previously 
published in a proposed rule or endorsed by an entity with a contract 
under section 1890(a) of the Act. However, we proposed to request that 
stakeholders apply the following considerations when submitting quality 
measures for possible inclusion in MIPS:
     Measures that are not duplicative of an existing or 
proposed measure.
     Measures that are beyond the measure concept phase of 
development and have started testing, at a minimum, with strong 
encouragement and preference for measures that have completed or are 
near completion of reliability and validity testing.
     Measures that include a data submission method beyond 
claims-based data submission.
     Measures that are outcome-based rather than clinical 
process measures.
     Measures that address patient safety and adverse events.
     Measures that identify appropriate use of diagnosis and 
therapeutics.
     Measures that address the domain for care coordination.
     Measures that address the domain for patient and caregiver 
experience.
     Measures that address efficiency, cost, and resource use.
     Measures that address significant variation in 
performance.
    We will apply these considerations when considering quality 
measures for possible inclusion in MIPS.
    In addition, we note that we are likely to reject measures that do 
not provide substantial evidence of variation in performance; for 
example, if a measure developer submits data showing a small variation 
in performance among a group already composed of high performers, such 
evidence would not be substantial enough to assure us that sufficient 
variation in performance exists. We also noted that we are likely to 
reject measures that are not outcome-based measures, unless: (1) There 
is substantial documented and peer reviewed evidence that the clinical 
process measured varies directly with the outcome of interest; and (2) 
it is not possible to measure the outcome of interest in a reasonable 
timeframe.
    We also noted that retired measures that were in one of CMS's 
previous quality programs, such as the Physician Quality Reporting 
System (PQRS) program, will likely be rejected if proposed for 
inclusion. This includes measures that were retired due to being topped 
out, as defined below. For example, measures may be retired due to 
attaining topped out status because of high performance, or measures 
that are retired due to a change in the evidence supporting their use.
    In the CY 2017 Quality Payment Program final rule (81 FR 77153), we 
established that we will categorize measures into the six NQS domains 
(patient safety, person- and caregiver-centered experience and 
outcomes, communication and care coordination, effective clinical care, 
community/population health, and efficiency and cost reduction). We 
intend to submit future MIPS quality measures to the NQF-convened 
Measure Application Partnership's (MAP), as appropriate, and we intend 
to consider the MAP's recommendations as part of the comprehensive 
assessment of each measure considered for inclusion under MIPS.
    In the CY 2017 Quality Payment Program final rule (81 FR 77155), we 
established that we use the Call for Quality Measures process as a 
forum to gather the information necessary to draft the journal articles 
for submission from measure developers, measure owners and measure 
stewards. The submission of this information does not preclude us from 
conducting our own research using Medicare claims data, Medicare survey 
results, and other data sources that we possess. We submit new measures 
for publication in applicable specialty-appropriate, peer-reviewed 
journals before including such measures in the final annual list of 
quality measures.
    In the CY 2017 Quality Payment Program final rule (81 FR 77158), we 
established at Sec.  414.1330(a)(2) that for purposes of assessing 
performance of MIPS eligible clinicians in the quality performance 
category, we use quality measures developed by QCDRs. In the 
circumstances where a QCDR wants to use a QCDR measure for inclusion in 
the MIPS program for reporting, those measures go through a CMS 
approval process during the QCDR self-nomination period. We also 
established that we post the quality measures for use by QCDRs by no 
later than January 1 for performance periods occurring in 2018 and 
future years.
    Previously finalized MIPS quality measures can be found in the CY 
2017 Quality Payment Program final rule (81 FR 77558 through 77675). 
Updates may include the addition of proposed new MIPS quality measures, 
including measures selected 2 years ago during the Call for Measures 
process. The new MIPS quality measures proposed for inclusion in MIPS 
for the 2018 performance period and future years were found in Table A 
of the CY 2018 Quality Payment Program proposed rule (82 FR 30261 
through 30270). The proposed new and modified MIPS specialty sets for 
the 2018 performance period and future years were listed in Table B of 
the CY 2018 Quality Payment Program proposed rule (82 FR 30271 through 
30454), and included existing measures that were proposed with 
modifications, new measures, and measures finalized in the CY 2017 
Quality Payment Program final rule. We noted that the modifications 
made to the specialty sets may include the removal of certain quality 
measures that were previously finalized. The specialty measure sets 
should be used as a guide for eligible clinicians to choose measures 
applicable to their specialty. To clarify, some of the MIPS specialty 
sets have further defined subspecialty sets, each of which is 
effectively a separate specialty set. In instances where an individual 
MIPS eligible clinician or group reports on a specialty or subspecialty 
set, if the set has less than six measures, that is all the clinician 
is required to report. MIPS eligible clinicians are not required to 
report on the specialty measure sets, but they are suggested measures 
for specific specialties. Throughout measure utilization, measure 
maintenance should be a continuous process done by the measure owners, 
to include environmental scans of scientific literature about the 
measure. New information gathered during this ongoing review may 
trigger an ad hoc review. Please note that these specialty specific 
measure sets are not all inclusive of every specialty or subspecialty. 
On January 25, 2017, we announced that we would be accepting

[[Page 53637]]

recommendations for potential new specialty measure sets for year 2 of 
MIPS under the Quality Payment Program. These recommendations were 
based on the MIPS quality measures finalized in the CY 2017 Quality 
Payment Program final rule, and include recommendations to add or 
remove the current MIPS quality measures from the specialty measure 
sets. The current specialty measure sets can be found on the Quality 
Payment Program Web site at https://qpp.cms.gov/measures/quality. All 
specialty measure sets submitted for consideration were assessed to 
ensure that they met the needs of the Quality Payment Program.
    As a result, we proposed (82 FR 30045) to add new quality measures 
to MIPS (Table A in the proposed rule (82 FR 30261 through 30270)), 
revise the specialty measure sets in MIPS (Table B in the proposed rule 
(82 FR 30271 through 30454)), remove specific MIPS quality measures 
only from specialty sets (Table C.1 in the proposed rule (82 FR 30455 
through 30462)), and proposed to remove specific MIPS quality measures 
from the MIPS program for the 2018 performance period (Table C.2 in the 
proposed rule (82 FR 30463 through 30465)). In addition, we proposed to 
also remove cross cutting measures from most of the specialty sets. 
Specialty groups and societies reported that cross cutting measures may 
or may not be relevant to their practices, contingent on the eligible 
clinicians or groups. We chose to retain the cross cutting measures in 
Family Practice, Internal Medicine, and Pediatrics specialty sets 
because they are frequently used in these practices. The proposed 2017 
cross cutting measures (81 FR 28447 through 28449) were compiled and 
placed in a separate table for eligible clinicians to elect to use or 
not, for reporting. To clarify, the cross-cutting measures are intended 
to provide clinicians with a list of measures that are broadly 
applicable to all clinicians regardless of the clinician's specialty. 
Even though it is not required to report on cross-cutting measures, it 
is provided as a reference to clinicians who are looking for additional 
measures to report outside their specialty. We continue to consider 
cross-cutting measures to be an important part of our quality measure 
programs, and seek comment on ways to incorporate cross-cutting 
measures into MIPS in the future. The Table of Cross-Cutting Measures 
can be found in Table D of the Appendix in the CY 2018 Quality Payment 
Program proposed rule (82 FR 30466 through 30467).
    For MIPS quality measures that are undergoing substantive changes, 
we proposed to identify measures including, but not limited to measures 
that have had measure specification, measure title, and domain changes. 
MIPS quality measures with proposed substantive changes can be found at 
Table E of the Appendix in the CY 2018 Quality Payment Program proposed 
rule (82 FR 30468 through 30478).
    The measures that would be used for the APM scoring standard and 
our authority for waiving certain measure requirements are described in 
section II.C.6.g.(3)(b)(ii) of this final rule with comment period, and 
the measures that would be used to calculate a quality score for the 
APM scoring standard are proposed in Tables 14, 15, and 16 of the CY 
2018 Quality Payment Program proposed rule (82 FR 30091 through 30095).
    We also sought comment on whether there are any MIPS quality 
measures that commenters believe should be classified in a different 
NQS domain than what is being proposed, or that should be classified as 
a different measure type (for example, process vs. outcome) than what 
we proposed (82 FR 30045). We did not receive any public comments in 
response to this solicitation.
    The following is a summary of the public comments received on the 
``Background and Policies for the Call for Measures and Measure 
Selection Process proposals and our responses:
    Comment: A few commenters supported the proposal to remove cross-
cutting measures from most specialty sets. One commenter agreed that 
cross-cutting measures may or may not be relevant to certain practices.
    Response: We appreciate the commenters support.
    Comment: One commenter recommended that CMS retain cross-cutting 
measures in specialty sets with fewer than six measures because the 
commenter believed it would allow parity in quality measure reporting 
across all clinicians and provide incentives for all specialties to 
develop quality measures.
    Response: We did not retain the cross-cutting measures in all the 
specialty sets, including those sets with less than six measures, 
because we believe that cross-cutting measures are not necessarily 
reflective of all specialty groups' scope of their practice. One goal 
of the MIPS program is to ensure that meaningful measurement occurs, 
and CMS chose to retain the cross cutting measures in Family Practice, 
Internal Medicine, and Pediatrics specialty sets because they are 
frequently used in these practices. The cross-cutting measures are 
intended to provide clinicians with a list of measures that are broadly 
applicable to all clinicians regardless of the clinician's specialty. 
Even though MIPS eligible clinicians are not required to report on 
cross-cutting measures, they are provided as a reference to clinicians 
who are looking for additional measures to report outside their 
specialty.
    Final Action: After consideration of the public comments received, 
we refer readers to the appendix of this final rule with comment period 
for the finalized list of new quality measures available for reporting 
in MIPS for the 2018 performance period and future years (Table A); the 
finalized specialty measure sets available for reporting in MIPS for 
the 2018 performance period and future years (Table B); the MIPS 
quality measures removed only from specialty sets for the 2018 
performance period and future years (Table C.1); the MIPS quality 
measures removed from the MIPS program for the 2018 performance period 
and future years (Table C.2); the cross-cutting measures available for 
the 2018 MIPS performance period and future years (Table D); and the 
MIPS quality measures finalized with substantive changes for the 2018 
performance period and future years (Table E).
(2) Topped Out Measures
    As defined in the CY 2017 Quality Payment Program final rule at (81 
FR 77136), 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. Topped out measures 
could have a disproportionate impact on the scores for certain MIPS 
eligible clinicians, and provide little room for improvement for the 
majority of MIPS eligible clinicians. We refer readers to section 
II.C.7.a.(2)(c) of this final rule with comment period for additional 
information regarding the scoring of topped out measures.
    Although we proposed a 3-year timeline to identify and propose to 
remove (through future rulemaking) topped out measures (82 FR 30046). 
We would like to clarify that the proposed timeline is more accurately 
described as a 4-year timeline. After a measure has been identified as 
topped out for 3 consecutive years, we may propose to remove the 
measure through notice-and-comment rulemaking for the 4th year. 
Therefore, in the 4th year, if finalized through rulemaking, the 
measure would be removed and would no longer be available for reporting 
during the performance period. This proposal would provide a path 
toward removing topped out measures over time, and will

[[Page 53638]]

apply to the MIPS quality measures. QCDR measures that consistently are 
identified as topped out according to the same timeline as proposed 
below, would not be approved for use in year 4 during the QCDR self-
nomination review process. These identified QCDR measures would not be 
removed through the notice-and-comment and rulemaking process described 
below.
    We proposed to phase in this policy starting with a select set of 
six highly topped out measures identified in section II.C.7.a.(2)(c) of 
this final rule with comment period. We also proposed to phase in 
special scoring for measures identified as topped out in the published 
benchmarks for 2 consecutive performance periods, starting with the 
select set of highly topped out measures for the 2018 MIPS performance 
period. An example illustrating the proposed timeline for the removal 
and special scoring of topped out measures, as it would be applied to 
the select set of highly topped out measures identified in section 
II.C.7.a.(2)(c) of this final rule with comment period, is as follows:
     Year 1: Measures are identified as topped out in the 
benchmarks published for the 2017 MIPS performance Period. The 2017 
benchmarks are posted on the Quality Payment Program Web site: https://qpp.cms.gov/resources/education.
     Year 2: Measures are identified as topped out in the 
benchmarks published for the 2018 MIPS performance period. We refer 
readers to section II.C.7.a.(2)(c) of this final rule with comment 
period for additional information regarding the scoring of topped out 
measures.
     Year 3: Measures are identified as topped out in the 
benchmarks published for the 2019 MIPS performance period. The measures 
identified as topped out in the benchmarks published for the 2019 MIPS 
performance period and the previous two consecutive performance periods 
would continue to have special scoring applied for the 2019 MIPS 
performance period and would be considered, through notice-and-comment 
rulemaking, for removal for the 2020 MIPS performance period.
     Year 4: Topped out measures that are finalized for removal 
are no longer available for reporting. For example, the measures in the 
set of highly topped out measures identified as topped out for the 
2017, 2018 and 2019 MIPS performance periods, and if subsequently 
finalized for removal will not be available on the list of measures for 
the 2020 MIPS performance period and future years.
    For all other measures, the timeline would apply starting with the 
benchmarks for the 2018 MIPS performance period. Thus, the first year 
any other topped out measure could be proposed for removal would be in 
rulemaking for the 2021 MIPS performance period, based on the 
benchmarks being topped out in the 2018, 2019, and 2020 MIPS 
performance periods. If the measure benchmark is not topped out during 
one of the 3 MIPS performance periods, then the lifecycle would stop 
and start again at year 1 the next time the measure benchmark is topped 
out.
    We sought comment on the proposed timeline; specifically, regarding 
the number of years before a topped out measure is identified and 
considered for removal, and under what circumstances we should remove 
topped out measures once they reach that point (82 FR 30046). We also 
noted that if for some reason a measure benchmark is topped out for 
only one submission mechanism benchmark, then we would remove that 
measure from the submission mechanism, but not remove the measure from 
other submission mechanisms available for submitting that measure. The 
comments we received and our responses are discussed further below.
    We also sought comment on whether topped out Summary Survey 
Measures (SSMs), if topped out, should be considered for removal from 
the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for 
MIPS Clinician or Group Survey measure due to high, unvarying 
performance within the SSM, or whether there is another alternative 
policy that could be applied for topped out SSMs within the CAHPS for 
MIPS Clinician or Group Survey measure (82 FR 30046). We received a 
comment on this item and appreciate the input received. As this was a 
request for comment only, we will take the feedback provided into 
consideration for future rulemaking.
    In the CY 2017 Quality Payment Program final rule, we stated that 
we do not believe it would be appropriate to remove topped out measures 
from the CMS Web Interface for the Quality Payment Program because the 
CMS Web Interface measures are used in MIPS and in APMs, such as the 
Shared Savings Program. Removing topped out measures from the CMS Web 
Interface would not be appropriate because we have aligned policies 
where possible, with the Shared Savings Program, such as using the 
Shared Savings Program benchmarks for the CMS Web Interface measures 
(81 FR 77285). In the CY 2017 Quality Payment Program final rule, we 
also finalized that MIPS eligible clinicians reporting via the CMS Web 
Interface must report all measures included in the CMS Web Interface 
(81 FR 77116). Thus, if a CMS Web Interface measure is topped out, the 
CMS Web Interface reporter cannot select other measures. We refer 
readers to section II.C.7.a.(2) of this final rule with comment period 
for information on scoring policies with regards to topped out measures 
from the CMS Web Interface for the Quality Payment Program. We did not 
propose to include CMS Web Interface measures in our proposal on 
removing topped out measures.
    The following is a summary of the public comments received on the 
``Topped Out Measures'' proposals and our responses:
    Comment: Many commenters supported the proposed timeline for 
identification and removal of topped out measures because the process 
relies on multiple years of data and the lifecycle permits enough time 
to avoid disadvantaging certain clinicians who may report these 
measures. The commenters supported the lifecycle over multiple years to 
find a trend in high performance, providing time for consideration of 
replacement measures to sustain the focus on clinical areas where 
improvement opportunities exist. A few commenters supported the 
timeline and encouraged CMS to develop a more comprehensive approach to 
identifying topped out measures, to ensure that voluntary reporting on 
a menu of quality measures does not allow eligible clinicians to 
`cherry pick' measures. One commenter supported not applying the topped 
out measure policies to measures in the CMS Web Interface to align with 
measures used in APMs such as the Shared Savings Program for the CMS 
Web Interface submission mechanism for the Quality Payment Program.
    Response: We agree that by identifying and removing topped out 
measures, we may greatly reduce eligible clinicians' ability to 
``cherry pick'' measures. We believe that the benchmarks will help us 
identify those measures that meet our definition of topped out 
measures.
    Comment: Many commenters did not support removal of the measures, 
because they noted: Benchmarks published for the 2017 performance 
period were not derived from MIPS reported data; criteria to identify 
topped out measures did not include consideration of important clinical 
considerations including patient safety and the ability to accurately 
measure and motivate high quality care; and removal of measures may 
disproportionately impact one submission mechanism or clinicians

[[Page 53639]]

based on medical specialty, practice size or regional variation. 
Several commenters indicated that identification of topped out measures 
is challenging because measures are voluntarily selected with limited 
reporting on each measure, and thus benchmarks may appear to be topped 
out when in fact there is still the room for improvement. A few 
commenters cautioned against removing measures because this may lead to 
``back sliding'' due to a shift in resources from support of current 
practices yielding high performance to new practices to support a new 
measure. Several commenters indicated that the criteria for selection 
of topped out measures should be expanded to consider the clinical 
importance of measures, and a few commenters recommended the 
identification of measures that are essential for high quality care 
such as patient safety, public health or patient experience that should 
never be removed from the list of measures. Many commenters voiced 
concern over the potential number of measures that may be topped out 
which they believed would leave eligible clinicians, particularly 
specialists with few relevant measures to submit. Many commenters 
recommended only removing topped out measures if there are adequate 
replacement measures added to the measures list. A few commenters 
indicated that topped out measures could be incorporated into composite 
measures reflecting multiple, important aspects of care. A few 
commenters recommended that prior to the removal of a measure, CMS 
evaluate the topped out measure across submission mechanisms to 
determine if the measure is harmonized across submission mechanisms.
    Response: The benchmarks for the 2017 performance period are 
derived from the measure's historical performance data which helps us 
trend the measure's anticipated performance in the future. Topped out 
measures are considered topped out if the measure performance is so 
high and unvarying that meaningful differences and improvement in 
performance can no longer be seen. Retaining topped out measures could 
have a disproportionate impact on the scores for certain MIPS eligible 
clinicians. We note that topped out measures must be consecutively 
identified for 3 years (in MIPS) as topped out before it is proposed 
for removal in the 4th year through rulemaking and comment period. As a 
part of the topped out measure timeline, we will take into 
consideration other factors such as clinical relevance and the 
availability of other relevant specialty measures prior to deciding 
whether or not to remove the measure from the program. Through the Call 
for Measures process and annual approval of QCDR measures, we 
anticipate that MIPS eligible clinicians and groups will have measures 
that provide meaningful measurement and are reflective of their current 
scope of practice. We believe that through the annual Call for Measures 
and QCDR self-nomination processes additional quality measures will be 
developed and implemented in the program, that will provide eligible 
clinicians and groups with a continuously growing selection of measures 
to choose from that will allow for meaningful measurement. We recognize 
that there are certain types of high value measures such as patient 
safety and patient experience, but we disagree that such measures 
should be designated as never to be removed from the list of available 
quality measures. We thank the commenters for their suggestion to 
remove topped out measures if there are adequate replacement measures 
added to the measures list, and we will take this into consideration, 
while encouraging measure stewards to submit measures to us through the 
Call for Measures process. We would like to note that this policy 
creates a standard timeline for us to consider which measures are 
topped out and may need to be removed. Each removal would need to be 
proposed and finalized through rulemaking, and we would have the 
discretion to retain any particular measure that, after consideration 
of public comments and other factors, may be determined to be 
inappropriate for removal.
    Comment: Several commenters did not support the removal of topped 
out measures from QCDR submissions because commenters believed this 
would reduce the ability of specialists to develop and strengthen new 
measures. A few commenters believed that not including QCDR measures in 
the topped out measure policy would ensure that eligible clinicians, 
including anesthesia clinicians, have measures of merit during the 
transition to full implementation of MIPS. One commenter urged CMS not 
to remove QCDR topped out measures but rather allow topped out measures 
as controls for new and developing measures by which true statistical 
validity and reliability can be assessed. One commenter voiced concern 
over potential removal of QCDR topped out measures without going 
through the notice-and-comment rulemaking process. One commenter 
indicated that EHR measures used by QCDRs are less likely to be topped 
out because QCDRs led by specialty societies have significant expertise 
in quality measure development, measurement, and implementation, and 
are uniquely poised to develop and test meaningful measures. The 
commenter indicated that specialty registries can continue to monitor 
vital topped out measures, even if the measures are removed from MIPS 
reporting. A few commenters noted that many topped out process measures 
are important to monitor and to provide feedback to clinicians because 
less than very high performance is concerning and should be flagged.
    Response: We disagree that the removal of topped out QCDR measures 
would reduce the ability of specialists to develop and strengthen new 
measures. Rather, we believe that QCDRs can develop QCDR measures that 
would address areas in which there is a known performance gap and in 
which there is need for improvement. We also disagree that the removal 
of QCDR measures should occur through the notice-and-comment rulemaking 
process, as QCDR measures are not approved for use in the program 
through rulemaking. We refer readers to section 1848(q)(2)(D)(vi) of 
the Act, which expressly provides that QCDR measures are not subject to 
the notice-and-comment rulemaking requirements described in section 
1848(q)(2)(D)(i) of the Act that apply to other MIPS measures, and that 
the Secretary is only required to publish the list of QCDR measures on 
the CMS Web site. We appreciate the QCDRs expertise in given areas of 
specialty, but as previously indicated, we will utilize benchmarks for 
all submission mechanisms to appropriately identify measures as topped 
out, and will consider performance in all submission mechanisms before 
indicating that a given measure is topped out. QCDR measures should 
also be removed from MIPS through a similar timeline when QCDR measures 
meet the definition of a topped out measure. We understand the 
importance of monitoring high performance among clinicians, but we also 
believe that topped out QCDR measures may inadvertently penalize 
clinicians who are considered high performers when they are compared to 
other high performer clinicians, as described in the CY 2017 Quality 
Payment Program final rule (81 FR 77286). For example, a clinician who 
performs at the 90th percentile, when compared to another high 
performing clinician who scored in the 98th percentile, could 
potentially receive a lower score based on the cohort in

[[Page 53640]]

which they are compared. QCDR measures, their performance data, and 
clinical relevance are reviewed extensively as QCDRs self-nominate and 
submit their QCDR measures for consideration on an annual basis. We 
agree that specialty registries can continue to monitor their data 
submission of topped out measures for purposes of monitoring 
performance and improvement, even after the measures are removed from 
MIPS. Additional data provided by QCDRs or discussions about their QCDR 
measures is taken into consideration during the review process.
    Comment: A few commenters encouraged CMS to have a transparent 
process using multiple communication processes to indicate which 
measures are topped out and which measures will have the scoring cap to 
ensure MIPS eligible clinicians have the necessary time to alter their 
reporting under the quality performance category before topped-out 
measures are finalized for removal. Some commenters recommended that 
CMS provide detailed information on the measures considered to be 
topped-out, including the number and type of clinicians or groups 
reporting the measure each year, the number and type of clinicians or 
groups consistently reporting the measure, the range of performance 
scores and any statistical testing information. Other commenters 
suggested that CMS announce the status of a topped out measure in a 
draft proposed rule with at least a 45-day comment period. One 
commenter urged CMS to announce topped out measures at a consistent 
time each year.
    Response: We intend to indicate which measures are topped out 
through the benchmarks that will be published on the Quality Payment 
Program Web site annually, as feasible prior to the beginning of each 
performance period. We intend to consider, and as appropriate, propose 
removal of topped out measures in future notice-and-comment rulemaking 
in accordance with the proposed timeline. We thank commenters for their 
suggestions as to what information should be available on measures 
considered topped out and will provide additional data elements, as 
technically feasible and appropriate.
    Comment: A few commenters did not support the proposed lifecycle 
and made suggestions regarding the delay of the initiation of the 
lifecycle or extension to the timeline, to allow more time to adjust 
and continue to demonstrate improvement over time within MIPS. A few 
commenters recommended lengthening the lifecycle by 1 year, allowing 
the measure to be scored for 2 years after the measure is identified as 
topped out. The commenters indicated this will support MIPS eligible 
clinicians in incorporating appropriate measures into EHR systems and 
updating clinical practice. Several commenters recommended a delay in 
the start of the lifecycle to allow benchmarks to be developed from 
MIPS data and a more representative sample, while giving time for MIPS 
eligible clinicians to experience the program. One commenter requested 
a delay in the initiation of the lifecycle for measures without a 
benchmark to allow additional submissions in future years which may 
lead to the development of benchmarks.
    Response: We note that the topped out measure lifecycle has built 
in a 4-year timeline, which would be triggered when topped out measures 
are identified through the benchmarks as topped out. We believe the 4-
year timeline would provide MIPS eligible clinicians, groups, and 
third-party intermediaries with a sufficient amount of time to adjust 
to the removal of identified topped out measures. Topped out measures 
are identified through the benchmarks, and cannot be identified as 
topped out until the benchmark is established. We would like to note 
that this policy creates a standard timeline for us to consider which 
measures are topped out and may need to be removed. Each removal would 
need to be proposed and finalized through rulemaking, and we would have 
the discretion to retain any particular measure that, after 
consideration of public comments and other factors may be determined to 
be inappropriate for removal. We believe that the 4-year timeline will 
provide MIPS eligible clinicians with sufficient time to incorporate 
measures into their EHR systems and to update their clinical practice.
    Comment: A few commenters did not support the proposed topped out 
measure removal timeline, noting that the proposal would delay the 
retirement of topped out measures and selection and use of different 
quality measures. One commenter believed that allowing performance to 
be supported by the selection of topped out measures will not provide 
sufficient incentive for eligible clinicians to select the more 
challenging and difficult measures available.
    Response: We believe that the topped out measure timeline reflects 
a sufficient amount of time in which we are able to clearly distinguish 
topped out measures through their performance in the benchmarks. The 
timing will allow us to take into consideration any variances in the 
benchmarks, and provide sufficient timing to request public comment on 
the proposed removal of topped out measures. There are a variety of 
quality and QCDR measures to choose from in the MIPS program, and we 
encourage MIPS individual eligible clinicians and groups to select 
measures that provide meaningful measurement for them.
    Final Action: After consideration of the public comments received 
and since topped out measures may provide little room for improvement 
for the majority of MIPS eligible clinicians, and a disproportionate 
impact on the scores for certain MIPS eligible clinicians, we are 
finalizing our proposed 4-year timeline to identify topped out 
measures, after which we may propose to remove the measures through 
future rule making topped out measures. After a measure has been 
identified as topped out for 3 consecutive years, we may propose to 
remove the measure through notice and comment rulemaking for the 4th 
year. Therefore, in the 4th year, if finalized through rulemaking, the 
measure would be removed and would no longer be available for reporting 
during the performance period. This policy provides a path toward 
removing topped out MIPS quality measures over time. QCDR measures that 
consistently are identified as topped out according to the same 
timeline would not be approved for use in year 4 during the QCDR self-
nomination review process. Removal of these QCDR measures would not go 
through the comment and rulemaking process as MIPS quality measures 
would.
(3) Non-Outcome Measures
    In the CY 2017 Quality Payment Program final rule, we sought 
comment on whether we should remove non-outcomes measures for which 
performance cannot reliably be scored against a benchmark (for example, 
measures that do not have 20 reporters with 20 cases that meet the data 
completeness standard) for 3 years in a row (81 FR 77288).
    Based on the need for CMS to further assess this issue, we did not 
propose to remove non-outcome measures. However, we sought comment on 
what the best timeline for removing both non-outcome and outcome 
measures that cannot be reliably scored against a benchmark for 3 years 
(82 FR 30047). We received a number of comments on this item and 
appreciate the input received. As this was a request for comment only, 
we will take the feedback provided into consideration for future 
rulemaking.

[[Page 53641]]

(4) Quality Measures Determined To Be Outcome Measures
    Under the MIPS, individual MIPS eligible clinicians are generally 
required to submit at least one outcome measure, or, if no outcome 
measure is available, one high priority measure. As such, our 
determinations as to whether a measure is an outcome measure is of 
importance to stakeholders. We did not make any proposals on how 
quality measures are determined to be outcome measures, and refer 
readers to the CY 2018 Quality Payment Program proposed rule (82 FR 
30047) for the criteria utilized in determining if a measure is 
considered an outcome measure. We sought comment on the criteria and 
process outlined in the proposed rule on how we designate outcome 
measures (82 FR 30047). We received a number of comments on this item 
and appreciate the input received. As this was a request for comment 
only, we will take the feedback provided into consideration for future 
rulemaking.
d. Cost Performance Category
(1) Background
(a) General Overview
    Measuring cost is an integral part of measuring value as part of 
MIPS. In implementing the cost performance category for the transition 
year (2017 MIPS performance period/2019 MIPS payment year), we started 
with measures that had been used in previous programs (mainly the VM) 
but noted our intent to move towards episode-based measurement as soon 
as possible, consistent with the statute and the feedback from the 
clinician community. Specifically, we adopted 2 measures that had been 
used in the VM: The total per capita costs for all attributed 
beneficiaries measure (referred to as the total per capita cost 
measure); and the MSPB measure (81 FR 77166 through 77168). We also 
adopted 10 episode-based measures that had previously been included in 
the Supplemental Quality and Resource Use Reports (sQRURs) (81 FR 77171 
through 77174).
    At Sec.  414.1325(e), we finalized that all measures used under the 
cost performance category would be derived from Medicare administrative 
claims data and, thus, participation would not require additional data 
submission. We finalized a reliability threshold of 0.4 for measures in 
the cost performance category (81 FR 77170). We also finalized a case 
minimum of 35 for the MSPB measure (81 FR 77171) and 20 for the total 
per capita cost measure (81 FR 77170) and each of the 10 episode-based 
measures (81 FR 77175) in the cost performance category to ensure the 
reliability threshold is met.
    For the transition year, we finalized a policy to weight the cost 
performance category at zero percent of the final score in order to 
give clinicians more opportunity to understand the attribution and 
scoring methodologies and gain more familiarity with the measures 
through performance feedback so that clinicians may take action to 
improve their performance (81 FR 77165 through 77166). In the CY 2017 
Quality Payment Program final rule, we finalized a cost performance 
category weight of 10 percent for the 2020 MIPS payment year (81 FR 
77165). For the 2021 MIPS payment year and beyond, the cost performance 
category will have a weight of 30 percent of the final score as 
required by section 1848(q)(5)(E)(i)(II)(aa) of the Act.
    For descriptions of the statutory basis and our existing policies 
for the cost performance category, we refer readers to the CY 2017 
Quality Payment Program final rule (81 FR 77162 through 77177).
    As finalized at Sec.  414.1370(g)(2), the cost performance category 
is weighted at zero percent for MIPS eligible clinicians scored under 
the MIPS APM scoring standard because many MIPS APMs incorporate cost 
measurement in other ways. For more on the APM scoring standard, see 
II.C.6.g. of this final rule with comment period.
(2) Weighting in the Final Score
    We proposed at Sec.  414.1350(b)(2) to change the weight of the 
cost performance category from 10 percent to zero percent for the 2020 
MIPS payment year. We noted that we continue to have concerns about the 
level of familiarity with and understanding of cost measures among 
clinicians. We noted that we could use the additional year where the 
cost performance category would not affect the final score to increase 
understanding of the measures so that clinicians would be more 
comfortable with their role in reducing costs for their patients. In 
addition, we could use this additional year to develop and refine 
episode-based cost measures, which are cost measures that are focused 
on clinical conditions or procedures. We intend to propose in future 
rulemaking policies to adopt episode-based measures currently in 
development.
    Although we believed that reducing this weight could be appropriate 
given the level of understanding of the measures and the scoring 
standards, we noted that section 1848(q)(5)(E)(i)(II)(aa) of the Act 
requires the cost performance category to be assigned a weight of 30 
percent of the MIPS final score beginning in the 2021 MIPS payment 
year. We recognized that assigning a zero percent weight to the cost 
performance category for the 2020 MIPS payment year may not provide a 
smooth enough transition for integrating cost measures into MIPS and 
may not provide enough encouragement to clinicians to review their 
performance on cost measures. Therefore, we sought comment on keeping 
the weight of the cost performance category at 10 percent for the 2020 
MIPS payment year (82 FR 30048).
    We invited public comments on this proposal of a zero percent 
weighting for the cost performance category and the alternative option 
of a 10 percent weighting for the cost performance category for the 
2020 MIPS payment year (82 FR 30048).
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters supported our alternative option to keep 
the weight of the cost performance category at 10 percent for the 2020 
MIPS payment year, as we previously finalized in the CY 2017 Quality 
Payment Program final rule. The commenters expressed concern that the 
statutorily mandated 30 percent weight of the cost performance category 
in the 2021 MIPS payment year would be too steep an increase from zero 
percent, and MIPS eligible clinicians would be unprepared. Some 
commenters indicated that they believed that cost measures are 
intrinsic measures of value and that clinicians can demonstrate value 
through lower costs. One commenter recommended that the cost 
performance category be weighted at 15 percent for the 2020 MIPS 
payment year.
    Response: We share the commenters' concerns about the increase in 
the weight of the cost performance category from zero percent in the 
2020 MIPS payment year to 30 percent in the 2021 MIPS payment year, 
which is statutorily required. We agree with the commenters that cost 
measures are an important component of value, and that weighting the 
cost category at 10 percent will help to provide a smoother transition 
for clinicians by giving them more time to experience cost measurement 
with the cost category having a lower relative weight of 10 percent. 
Furthermore, moving forward with a lower relative weight in 
anticipation of the requirement to go to 30 percent in the 2021 MIPS 
payment year will allow more time for the development of episode-based 
cost measures, which are being developed with substantial

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clinician input. We are therefore adopting our alternative option to 
maintain the 10 percent weight for the cost performance category for 
the 2020 MIPS payment year, as we finalized in the CY 2017 Quality 
Payment Program final rule (81 FR 77165).
    Comment: Many commenters supported our proposal to weight the cost 
performance category at zero percent of the final score for the 2020 
MIPS payment year. The commenters stated that MIPS eligible clinicians 
are still gaining familiarity with the scoring methodology and the cost 
measures and would appreciate additional time to review feedback 
reports. Some commenters supported the proposal because episode-based 
measures were not yet included and therefore many clinicians would not 
be measured in the cost performance category. Some commenters suggested 
that CMS use the additional time to continue to improve risk 
adjustment, attribution, and other components of cost measures.
    Response: We will continue to work to make clinicians more familiar 
with the measures and continue to refine the measures. However, we are 
concerned that not assigning any weight to the cost performance 
category when the weight is required to be at 30 percent in the third 
MIPS payment year will result in too dramatic a transition in a single 
year. We also agree with commenters that new episode-based cost 
measures will be an important part of the cost category, and intend to 
make future proposals about implementing episode-based measures as soon 
as they are developed.
    Comment: Several commenters stated that although the statute 
requires the cost performance category to be weighted at 30 percent of 
the final score in the third MIPS payment year, we should use 
flexibility in the statute to weight the cost performance category at 
zero percent or a percentage lower than 30 percent for the third MIPS 
payment year and for additional years in the future either by 
determining that there are no applicable measures in the cost 
performance category or using broader flexibility to reweight the 
performance categories. These commenters supported the zero percent 
weight for the 2020 MIPS payment year but believed that the cost 
performance category should not count towards the final score until 
clinicians have gained more experience with this category, episode-
based measures are more developed, and risk adjustment models are more 
robust.
    Response: While we understand the concerns of commenters, section 
1848(q)(5)(E) of the Act requires the cost performance category to be 
weighted at 30 percent of the final score beginning in the third MIPS 
payment year. We do not believe the statute affords us flexibility to 
adjust this prescribed weight, unless we determine there are not 
sufficient cost measures applicable and available to MIPS eligible 
clinicians under section 1848(q)(5)(F) of the Act. We believe that a 
clinician's influence on the costs borne by both patients and the 
Medicare program is an important component of measuring value as 
envisioned by the creation of the MIPS program. In addition, because of 
our concerns about the dramatic transition between the cost performance 
category being weighed at zero percent for a year and 30 percent for 
the next year, we are adopting our alternative to maintain the 10 
percent weight for the cost performance category for the 2020 MIPS 
payment year. We continue to work with clinicians to better understand 
the cost measures as they prepare for the category to be weighted at 30 
percent of the final score. We are seeking extensive input from 
clinicians on the development of episode-based measures and technical 
updates to existing measures in addition to providing feedback reports 
so that clinicians can better understand the measures.
    Comment: Several commenters recommended that the cost performance 
category be weighted at 10 percent in the 2020 MIPS payment year only 
for those clinicians who volunteer to be measured on cost. Other 
commenters expressed their support for a zero percent weighting but 
requested that clinicians be given information on how they would have 
scored under cost measurement.
    Response: We do not have the statutory authority to score cost 
measures on a voluntary basis under MIPS. Because the MIPS cost 
measures are calculated based on Medicare claims data and do not 
require additional reporting by clinicians, we are able to provide 
outreach and model scoring scenarios without clinicians volunteering to 
complete any actions. We are planning to provide feedback on both 
individual measures as well as the cost performance category to 
increase understanding and familiarity going into future years.
    Comment: Many commenters requested that CMS provide extensive 
feedback on cost measures and the cost performance category score to 
ensure that clinicians are best positioned for the cost performance 
category to be weighted at 30 percent of the final score for the 2021 
MIPS payment year.
    Response: We discuss in section II.C.9.a of this final rule with 
comment period our plans to provide performance feedback, including on 
cost measures. As noted there, we will also be providing information on 
newly developed episode-based measures which may become a part of the 
MIPS cost performance category in future years.
    Comment: A few commenters recommended that the cost performance 
category be weighted at zero percent for certain specialties or types 
of clinicians for an indefinite period of time because not enough 
measures are available for them. One commenter suggested that if at 
least one episode-based measure cannot be calculated for a clinician or 
group that they not be scored in the cost performance category.
    Response: We recognize that not every clinician will have cost 
measures attributed to them in the initial years of MIPS and therefore 
may not receive a cost performance category score. However, we do not 
believe that it is appropriate to exclude certain clinicians from cost 
measurement on the basis of their specialty if they are attributed a 
sufficient number of cases to meet the case minimum for the cost 
measure. We did not propose any episode-based measures for the 2018 
MIPS performance period. We address MIPS cost performance category 
scoring policies in section II.C.7.a.(3) of this final rule with 
comment period, but we did not propose any changes related to the 
minimum number of measures required to receive a cost performance 
category score. A MIPS eligible clinician must be attributed a 
sufficient number of cases for at least one cost measure, and that cost 
measure must have a benchmark, in order for the clinician to receive a 
cost performance category score (81 FR 77322 through 77323).
    Comment: One commenter recommended that small practices (defined as 
15 or fewer clinicians) not have the cost performance category 
contribute to the weight of their final score, at least until more 
valid and reliable measures are developed.
    Response: While we have a strong commitment to ensuring that small 
practices are able to participate in MIPS, we do not have the statutory 
authority to exempt small practices from the cost performance category. 
We have offered additional flexibility for small practices in a number 
of areas, including a small practice bonus that will be added to the 
final score for the 2020 MIPS payment year (see section II.C.7.b.(1)(c) 
of this final rule with comment period). Many of these policies are 
intended to recognize the different level of administrative or other 
support a small practice might have in comparison to a larger entity. 
Because the MIPS cost

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measures do not require reporting of data by clinicians other than the 
usual submission of claims, there is no additional administrative 
burden associated with being a small practice in the cost performance 
category. Furthermore, it is possible that some small practices will 
not have any cost measures applicable and available to them because 
they may not meet the case minimums for any of the cost measures. Other 
small practices may have a considerable volume of patients and wish to 
be rewarded for their commitment to reducing the cost of care.
    Comment: A few commenters recommended that the cost performance 
category be weighted at a percentage higher than zero percent but lower 
than 10 percent so that the cost performance category would have a 
limited contribution to the final score.
    Response: We are adopting our alternative of maintaining the cost 
performance category weight at 10 percent of the final score for the 
2020 MIPS payment year. We are doing so because we are concerned about 
the dramatic transition between a zero percent weight and the 30 
percent weight mandated for the 2021 MIPS payment year. We did receive 
many comments in favor of the 10 percent weight and do not believe that 
a weight below 10 percent will provide an easier transition to the 30 
percent weight for the 2021 MIPS payment year.
    Comment: Some commenters expressed general concern about our 
approach to measuring the cost performance category. Some suggested 
that cost measures should not be included if there are not quality 
measures for the same group of patients. A few commenters suggested 
that cost measures should only consider services that were personally 
provided or ordered by a clinician.
    Response: We have designed the Quality Payment Program to be 
flexible and allow clinicians to select quality measures that reflect 
their practice. We expect that most clinicians and groups will select 
measures based on the types of patients they typically see. Because the 
measures for the cost performance category are calculated based on 
Medicare claims submitted, we believe they will also reflect a 
clinician's practice. While we are finalizing cost measures that do not 
directly correspond to quality measures, we note that each performance 
category is weighted and combined to determine the final score. In that 
sense, we believe that we are measuring value by rewarding performance 
in quality while keeping down costs. We also believe that clinicians 
can influence the cost of services that they do not personally perform 
by improving care management with other clinicians and avoiding 
unnecessary services.
    Final Action: After consideration of the public comments, we are 
not finalizing our proposal to weight the cost performance category at 
zero percent of the final score for the 2020 MIPS payment year. We are 
instead adopting our alternative option to maintain the weight of the 
cost performance category at 10 percent of the final score for the 2020 
MIPS payment year as we finalized in the CY 2017 Quality Payment 
Program final rule (81 FR 77165).
(3) Cost Criteria
(a) Measures Proposed for the MIPS Cost Performance Category
(i) Background
    Under Sec.  414.1350(a), we specify cost measures for a performance 
period to assess the performance of MIPS eligible clinicians on the 
cost performance category. For the 2017 MIPS performance period, we 
will utilize 12 cost measures that are derived from Medicare 
administrative claims data. Two of these measures, the MSPB measure and 
total per capita cost measure, have been used in the VM (81 FR 77166 
through 77168), and the remaining 10 are episode-based measures that 
were included in the sQRURs in 2014 and 2015 (81 FR 77171 through 
77174).
    Section 1848(r) of the Act specifies a series of steps and 
activities for the Secretary to undertake to involve the physician, 
practitioner, and other stakeholder communities in enhancing the 
infrastructure for cost measurement, including for purposes of MIPS, 
which we summarized in detail in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30048).
(ii) Total Per Capita Cost and MSPB Measures
    For the 2018 MIPS performance period and future performance 
periods, we proposed to include in the cost performance category the 
total per capita cost measure and the MSPB measure as finalized for the 
2017 MIPS performance period (82 FR 30048 through 30049). We referred 
readers to the description of these measures in the CY 2017 Quality 
Payment Program final rule (81 FR 77164 through 77171). We proposed to 
include the total per capita cost measure because it is a global 
measure of all Medicare Part A and Part B costs during the performance 
period. MIPS eligible clinicians are familiar with the total per capita 
cost measure because the measure has been used in the VM since the 2015 
payment adjustment period and performance feedback has been provided 
through the annual QRUR since 2013 for a subset of groups that had 20 
or more eligible professionals) and to all groups in the annual QRUR 
since 2014 and mid-year QRUR since 2015. We proposed to use the MSPB 
measure because many MIPS eligible clinicians will be familiar with the 
measure from the VM, where it has been included since the 2016 payment 
adjustment period and in annual QRUR since 2014 and the mid-year QRUR 
since 2015, or its hospital-specified version, which has been a part of 
the Hospital VBP Program since 2015. In addition to familiarity, these 
two measures cover a large number of patients and provide an important 
measurement of clinician contribution to the overall population that a 
clinician encounters.
    We did not propose any changes to the methodologies for payment 
standardization, risk adjustment, and specialty adjustment for these 
measures and refer readers to the CY 2017 Quality Payment Program final 
rule (81 FR 77164 through 77171) for more information about these 
methodologies.
    We noted that we will continue to evaluate cost measures that are 
included in MIPS on a regular basis and anticipate that measures could 
be added or removed, subject to rulemaking under applicable law, as 
measure development continues. We will also maintain the measures that 
are used in the cost performance category by updating specifications, 
risk adjustment, and attribution as appropriate. We anticipate 
including a list of cost measures for a given performance period in 
annual rulemaking.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters opposed the inclusion of the total per 
capita cost measure and the MSPB measure as cost measures for the 2018 
MIPS performance period and future performance periods. Commenters 
expressed concern that these measures did not differentiate between 
services or circumstances that clinicians could control from those that 
they could not. The commenters stated that the MSPB measure had been 
developed for the hospital setting and had not been endorsed for use 
for clinician accountability by the NQF. The commenters stated that the 
total per capita cost measure had not been endorsed by the NQF. Some 
commenters recommended that these

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measures be eliminated when episode-based measures are made part of the 
program because episode-based measures are more focused on certain 
conditions.
    Response: Both the total per capita cost and MSPB measures were 
included in the QRURs and used in the VM for many years before the 
implementation of MIPS. These two measures cover a large number of 
patients and provide an important measurement of clinician contribution 
to the overall population that a clinician encounters. Like all of the 
cost measures that we have developed, we continue to refine these 
measures for improvement. If we find that episode-based measures would 
be an appropriate replacement for both of these measures, we would 
address that issue in future rulemaking. At this time, we believe that 
the total per capita and MSPB measures are tested and reliable for 
Medicare populations and are therefore the best measures available for 
the cost performance category. We are concurrently developing new 
episode-based cost measures with substantial clinician input, that we 
will consider for proposals in future rulemaking.
    Comment: Several commenters supported our proposal to include the 
total per capita cost measure and MSPB measure as cost measures for the 
2018 MIPS performance period. These commenters stated that these 
measures had been used in the legacy VM and would be applicable to many 
clinicians.
    Response: We appreciate the commenters for their support.
    Comment: A few commenters recommended that Part B drugs be excluded 
from the cost measures because Part D drugs are excluded. They 
suggested that including Part B drugs is unfair because it would 
penalize clinicians for prescribing or providing appropriate care.
    Response: We believe that clinicians play a key role in prescribing 
drugs for their patients and that the costs associated with drugs can 
be a significant contributor to the overall cost of caring for a 
patient. We do not believe it would be appropriate to remove the cost 
of Medicare Part B drugs from the cost measures, when other services 
that are ordered but not performed by clinicians, such as laboratory 
tests or diagnostic imaging, are included. Clinicians play a similar 
role in prescribing Part D drugs, and Part D drugs can also be a 
significant contributor to the overall cost of care. However, there are 
technical challenges that would need to be addressed to integrate Part 
D drug costs. Section 1848(q)(2)(B)(ii) of the Act requires CMS, to the 
extent feasible and applicable, to account for the cost of drugs under 
Medicare Part D as part of cost measurement under MIPS, and we will 
continue to explore the addition of this data in cost measures.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to include the total per capita cost and MSPB 
measures in the cost performance category for the 2018 MIPS performance 
period and future performance periods.
(iii) Episode-Based Measures
    Episode-based measures differ from the total per capita cost 
measure and MSPB measure because their specifications only include 
services that are related to the episode of care for a clinical 
condition or procedure (as defined by procedure and diagnosis codes), 
as opposed to including all services that are provided to a patient 
over a given period of time. For the 2018 MIPS performance period, we 
did not propose to include in the cost performance category the 10 
episode-based measures that we adopted for the 2017 MIPS performance 
period in the CY 2017 Quality Payment Program final rule (81 FR 77171 
through 77174). We instead will work to develop new episode-based 
measures, with significant clinician input, for future performance 
periods.
    We received extensive comments on our proposal to include 41 of 
these episode-based measures for the 2017 MIPS performance period, 
which we responded to in the CY 2017 Quality Payment Program final rule 
(81 FR 77171 through 77174). We also received additional comments after 
publication of that final rule with comment period about the decision 
to include 10 episode-based measures for the 2017 MIPS performance 
period. Although comments were generally in favor of the inclusion of 
episode-based measures in the future, there was also overwhelming 
stakeholder interest in more clinician involvement in the development 
of these episode-based measures as required by section 1848(r)(2) of 
the Act. Although there was an opportunity for clinician involvement in 
the development of some of the episode-based measures included for the 
2017 MIPS performance period, it was not as extensive as the process we 
are currently using to develop episode-based measures. We believe that 
the new episode-based measures, which we intend to propose in future 
rulemaking to include in the cost performance category for the 2019 
MIPS performance period, will be substantially improved by more 
extensive stakeholder feedback and involvement in the process.
    A draft list of care episodes and patient condition groups that 
could become episode-based measures used in the Quality Payment 
Program, along with trigger codes that would indicate the beginning of 
the episode, was posted for comment in December 2016 (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Episode-Based-Cost-Measure-Development-for-the-Quality-Payment-Program.pdf). This 
material was informed by engagement with clinicians from over 50 
clinician specialty societies through a Clinical Committee formed to 
participate in cost measure development. Subsequently, Clinical 
Subcomittees have been formed to provide input from a diverse array of 
clinicians on identifying conditions and procedures for episode groups. 
For the first set of episode-based cost measures being developed, the 
Clinical Subcommittees have nearly 150 clinicians affiliated with 
nearly 100 national specialty societies, recommending which services or 
claims would be counted in episode costs. This will ensure that cost 
measures in development are directly informed by a substantial number 
of clinicians and members of specialty societies.
    In addition, a technical expert panel has met to provide oversight 
and guidance for our development of episode-based cost measures. The 
technical expert panel has offered recommendations for defining an 
episode group, assigning costs to the group, attributing episode groups 
to clinicians, risk adjusting episodes, and aligning cost and quality. 
This expert feedback has been built into the current cost measure 
development process.
    As this process continues, we are continuing to seek input from 
clinicians. We believe that episode-based measures will benefit from 
this comprehensive approach to development. In addition, because it is 
possible that the new episode-based measures under development could 
address similar conditions as those in the episode-based measures 
finalized for the 2017 MIPS performance period, we believe that it 
would be better to focus attention on the new episode-based measures, 
so that clinicians would not receive feedback or scores from two 
measures for the same patient condition or procedure. We will endeavor 
to have as many episode-based measures available as possible for the 
2019 MIPS performance period but will continue to develop measures for 
potential consideration in the more distant future.
    Although we did not propose to include any episode-based measures 
in

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calculating the cost performance category score for the 2020 MIPS 
payment year, we noted that we do plan to continue to provide 
confidential performance feedback to clinicians on their performance on 
episode-based measures developed under the processes required by 
section 1848(r)(2) of the Act as appropriate in order to increase 
familiarity with the concept of episode-based measurement as well as 
the specific episodes that could be included in determining the cost 
performance category score in the future. We recently provided an 
initial opportunity for clinicians to review their performance based on 
the new episode-based measures, as the measures are developed and as 
the information is available. We note that this feedback will be 
specific to the new episode-based measures that are developed under the 
process described above and may be presented in a different format than 
MIPS eligible clinicians' performance feedback as described in section 
II.C.9.a. of this final rule with comment period. However, our 
intention is to align the feedback as much as possible to ensure 
clinicians receive opportunities to review their performance on 
potential new episode-based measures for the cost performance category 
prior to the 2019 MIPS performance period. We are concerned that 
continuing to provide feedback on the older episode-based measures 
along with feedback on new episode-based measures will be confusing and 
a poor use of resources. Because we are focusing on development of new 
episode-based measures, our feedback on episode-based measures that 
were previously developed will discontinue after 2017, as these 
measures would no longer be maintained or reflect changes in diagnostic 
and procedural coding. We intend to provide feedback on newly developed 
episode-based measures as they become available in a new format around 
summer 2018. We noted that the feedback provided in the summer of 2018 
will go to those MIPS eligible clinicians for whom we are able to 
calculate the episode-based measures, which means it would be possible 
a clinician may not receive feedback on episode-based measures in both 
the fall of 2017 and the summer of 2018. We believe that receiving 
feedback on the new episode-based measures will support clinicians in 
their readiness for the 2019 MIPS performance period.
    As previously finalized in the in the CY 2017 Quality Payment 
Program final rule (81 FR 77173), the 10 episode-based measures (which 
we did not propose for the 2018 MIPS performance period) will be used 
for determining the cost performance category score for the 2019 MIPS 
payment year in conjunction with the MSPB measure and the total per 
capita cost measure, although the cost performance category score will 
be weighted at zero percent in that year.
    The following is a summary of the public comments received and our 
responses:
    Comment: Many commenters supported our decision not to propose for 
the 2018 MIPS performance period the 10 episode-based measures that 
will be used for the 2017 MIPS performance period. These commenters 
stated that they supported the focus on the development of new episode-
based measures that are currently being developed under section 
1848(r)(2) of the Act and agreed that there would be confusion if 
multiple versions of episode-based measures existed.
    Response: We appreciate the commenters for their support.
    Comment: Many commenters expressed support for episode-based 
measurement but concern about our stated plan to introduce new episode-
based measures to be used in the cost performance category beginning in 
next year's proposed rule. Many commenters expressed support for the 
process that had prioritized clinician involvement but were concerned 
that the measures would not be able to be tested or understood by 
clinicians prior to their introduction in the MIPS program. Some 
commenters recommended that episode-based measures be made available 
for feedback for at least a year before contributing to the cost 
performance category percent score. Some commenters recommended that 
cost measures not be included unless they were endorsed by the NQF or 
recommended by the MAP.
    Response: As part of our episode-based measure development, we are 
completing an extensive outreach initiative in the fall of 2017 to 
share performance information with many clinicians on the newly 
developed episode-based measures as part of field testing, a part of 
measure development. We believe these efforts go beyond the typical 
testing associated with many performance measures and should reveal 
issues that were not clear during the development, which also included 
many clinician experts. We did not make any specific proposals related 
to the inclusion of episode-based measures in future years, but this 
development work is intended to develop measures that could be used in 
the MIPS cost performance category. All measures that will be included 
in the program would be included in a future proposed rule, and we 
would discuss the assessment and testing of the measures at the time of 
their proposal. Although CMS is conducting a rigorous process to ensure 
that any new measure is rigorously reviewed before implementation, we 
believe it is in the interest of MIPS participants, particularly 
certain specialists, to have access to new episode based measures. We 
will consider the opportunity to submit measures that have been or may 
be adopted for the cost performance category for NQF endorsement and to 
the MAP review process in the future.
    Comment: A few commenters recommended specific clinical topics for 
episode-based measures, including oncology care, chronic care, care of 
the frail elderly, and rare disease. One commenter recommended that CMS 
consider a measure that focuses on adherence to clinical pathways, 
rather than using costs of care, because clinical pathways would 
differentiate care that is appropriate from care that is not.
    Response: We appreciate the suggestions for future development of 
episode-based measures and other measures. We will continue to endeavor 
to develop measures that capture the cost of care for as many different 
types of patients and clinicians as possible. We would also review 
potential different methodologies as appropriate.
    Comment: Several commenters recommended that episode-based measures 
be developed so that all drugs costs are considered in the same manner, 
rather than Medicare Part B drugs being included and Medicare Part D 
drugs being excluded. These commenters suggested the clinical 
interchangeability of these types of drugs and expressed concern that 
they would be considered differently in determining cost measures.
    Response: Section 1848(q)(2)(B)(ii) of the Act requires CMS, to the 
extent feasible and applicable, to account for the cost of drugs under 
Medicare Part D as part of cost measurement under MIPS. As stated in 
the CY 2017 Quality Payment Program final rule, we will continue to 
explore methods to add Part D drug costs into cost measures in the 
future. We believe that Part D drugs are a significant contributor to 
costs for both patients and the Medicare program and should be measured 
when technically feasible. Episode-based measures may include Part B 
drug costs if clinically appropriate as we believe these are an 
important component of health spending.
    Comment: One commenter requested that CMS develop a process to 
allow stakeholders to develop their own cost measures, rather than only 
relying on

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the CMS episode-based measure development. This commenter suggested 
that this would allow for more leadership from relevant specialties of 
medicine.
    Response: Although we continue to develop episode-based measures, 
we are open to considering other types of measures for use in the cost 
performance category. If an episode-based measure or cost measure were 
to be created by an external stakeholder, we may consider it for 
inclusion in the program along the same criteria that we have used to 
develop and refine other cost measures.
    Comment: A few commenters opposed the decision to not propose the 
inclusion of the 10 episode-based measures as cost performance category 
measures for the 2018 MIPS performance period and for future 
performance periods. These commenters suggested that clinicians would 
benefit from having these measures as part of their score even as new 
episode-based measures are developed.
    Response: Many of the 10 episode-based measures that are included 
for the 2019 MIPS payment year have similar topics to those in the new 
list of episode-based measures we are currently developing. We believe 
that continuing to use these measures would create confusion. 
Furthermore, we want to potentially include episode-based cost measures 
that have significant clinician input, which is a cornerstone of the 
new episode-based cost measures currently being developed.
    Comment: A few commenters recommended that, in addition to episode-
based measures, we include condition-specific total per capita cost 
measures that were used in the VM.
    Response: We are currently focusing on the development of episode-
based measures. We continue to believe that the total per capita cost 
measure we have adopted is inclusive of the four condition-specific 
total per capita cost measures that have been used under the VM 
(chronic obstructive pulmonary disease, congestive heart failure, 
coronary artery disease, and diabetes mellitus).
    Final Action: After consideration of the public comments, for the 
2018 MIPS performance period, we will not include in the cost 
performance category the 10 episode-based measures that we adopted for 
the 2017 performance period, and we do not anticipate proposing to 
include these measures in future performance periods. We will continue 
to work on development and outreach for new episode-based measures, 
such as those that are undergoing field testing in October 2017, and 
may propose to include them in MIPS as appropriate in future 
rulemaking.
(iv) Attribution
    In the CY 2017 Quality Payment Program final rule, we changed the 
list of primary care services that had been used to determine 
attribution for the total per capita cost measure by adding 
transitional care management (CPT codes 99495 and 99496) codes and a 
chronic care management code (CPT code 99490) (81 FR 77169). In the CY 
2017 Physician Fee Schedule final rule, we changed the payment status 
for two existing CPT codes (CPT codes 99487 and 99489) that could be 
used to describe care management from B (bundled) to A (active) meaning 
that the services would be paid under the Physician Fee Schedule (81 FR 
80349). The services described by these codes are substantially similar 
to those described by the chronic care management code that we added to 
the list of primary care services beginning with the 2017 performance 
period. We therefore proposed to add CPT codes 99487 and 99489, both 
describing complex chronic care management, to the list of primary care 
services used to attribute patients under the total per capita cost 
measure (82 FR 30050).
    We did not propose any changes to the attribution methods for the 
MSPB measure and referred readers to the CY 2017 Quality Payment 
Program final rule (81 FR 77168 through 77169) for more information.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Some commenters supported the proposal to add CPT codes 
99487 and 99489 to the list of primary care services used to attribute 
patients under the total per capita cost measure, noting the similarity 
of these codes to other codes defined as primary care services for this 
purpose.
    Response: We appreciate the commenters for their support.
    Comment: Some commenters expressed concern that cost measures were 
being attributed to clinicians before patient relationship codes were 
being reported by clinicians. Some commenters recommended that cost 
measures not be used before the patient relationship codes are 
implemented and studied.
    Response: To facilitate the attribution of patients and episodes to 
one or more clinicians, section 1848(r)(3) of the Act requires the 
development of patient relationship categories and codes that define 
and distinguish the relationship and responsibility of a physician or 
applicable practitioner with a patient at the time of furnishing an 
item or service. In the CY 2018 Physician Fee Schedule proposed rule 
(82 FR 34129), we proposed to use certain HCPCS modifiers as the 
patient relationship codes. Section 1848(r)(4) of the Act requires 
claims submitted for items and services furnished by a physician or 
applicable practitioner on or after January 1, 2018, shall, as 
determined appropriate by the Secretary, include the applicable patient 
relationship code, in addition to other information. We proposed (82 FR 
34129) that for at least an initial period while clinicians gain 
familiarity, reporting the HCPCS modifiers on claims would be 
voluntary, and the use and selection of the modifiers would not be a 
condition of payment. The statute requires us to include the cost 
performance category in the MIPS program, and thus, we cannot delay the 
use of cost measures in MIPS until after the patient relationship codes 
have been implemented, as recommended by the commenters. However, we 
may consider future changes to our attribution methods for cost 
measures based on the patient relationship codes that will be reported 
on claims.
    Comment: One commenter recommended that services provided in a 
nursing facility (POS 32) not be included for purposes of attribution 
under the total per capita cost measure. One commenter recommended that 
services provided in a skilled nursing home facility (POS 31) continue 
to be excluded for purposes of attribution under the total per capita 
cost measure.
    Response: Patients in a skilled nursing home facility (SNF) (POS 
31) require more frequent practitioner visits--often from 1 to 3 times 
a week. In contrast, patients in nursing facilities (NFs) (POS 32) are 
almost always permanent residents and generally receive their primary 
care services in the facility for the duration of their life. On the 
other hand, patients in an NF (POS 32) are usually seen every 30 to 60 
days unless medical necessity dictates otherwise. We believe this 
distinction is important enough to treat these sites of service 
differently in terms of attribution for the total per capita cost 
measure. Services provided in POS 31 are not included in the definition 
of primary care services used for the total per capita cost measure, 
but services provided in POS 32 are. We will continue to evaluate 
attribution methods as part of measure development and maintenance.
    Comment: One commenter opposed the addition of complex chronic care 
management codes because palliative

[[Page 53647]]

care physicians often bill for the services, but serve in a consulting 
role as opposed to serving as a primary care clinician.
    Response: We believe that the attribution model that assigns 
patients on the basis of a plurality of services would not assign 
patients for the purposes of the total per capita cost measure on the 
basis of a single visit, unless that patient had also not seen a 
primary care clinician during the year. We believe these codes are 
consistent with other services typically provided by primary care 
clinicians.
    Comment: Many commenters expressed general concerns about 
attribution methods, stating that they were not well understood, were 
not properly tested, and were unfair. These commenters encouraged CMS 
to improve or perfect attribution methods.
    Response: We will continue to work to improve attribution methods 
as we develop the measures and methods that are part of the cost 
performance category. We do not use a single attribution method--
instead the attribution method is linked to a measure and attempts to 
best identify the clinician who may have influenced the spending for a 
patient, whether it be all spending in a year or a more narrow set of 
spending in a defined period. As we continue our work to develop 
episode-based measures and refine the two cost measures included for 
the 2018 MIPS performance period, we will work to explain the 
methodology for attribution and how it works in relation to the measure 
and the scoring methodology.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to add CPT codes 99487 and 99489 to the list of 
primary care services used to attribute patients under the total per 
capita cost measure.
(v) Reliability
    In the CY 2017 Quality Payment Program final rule (81 FR 77169 
through 77170), we finalized a reliability threshold of 0.4 for 
measures in the cost performance category. Reliability is an important 
evaluation for cost measures to ensure that differences in performance 
are not the result of random variation. In the proposed rule, we 
provided a summary of the importance of reliability in measurement and 
how high reliability must be balanced with other goals, such as 
measuring where there is significant variation and ensuring that cost 
measurement is not limited to large groups with large case volume (82 
FR 30050). Although we did not propose any adjustments to our 
reliability policies, we did receive a number of comments on issues 
related to reliability which we will consider as part of future 
rulemaking. We will continue to evaluate reliability as we develop new 
measures and to ensure that our measures meet an appropriate standard.
(b) Attribution for Individuals and Groups
    We did not propose any changes for how we attribute cost measures 
to individual and group reporters. We refer readers to the CY 2017 
Quality Payment Program final rule for more information (81 FR 77175 
through 77176). Although we did not propose any adjustments to our 
attribution policies, we did receive a number of comments on issues 
related to attribution which we will consider as part of future 
rulemaking.
(c) Incorporation of Cost Measures With SES or Risk Adjustment
    Both measures proposed for inclusion in the cost performance 
category for the 2018 MIPS performance period are risk adjusted at the 
measure level. Although the risk adjustment of the 2 measures is not 
identical, in both cases it is used to recognize the higher risk 
associated with demographic factors (such as age) or certain clinical 
conditions. We recognize that the risks accounted for with this 
adjustment are not the only potential attributes that could lead to a 
higher cost patient. Stakeholders have pointed to many other factors 
such as income level, race, and geography that they believe contribute 
to increased costs. These issues and our plans for attempting to 
address them are discussed in length in section II.C.7.b.(1)(a) of this 
final rule with comment period. While we did not propose any changes to 
address risk adjustment for cost measures in this rule, we continue to 
believe that this is an important issue and it will be considered 
carefully in the development of future cost measures and for the 
overall cost performance category. Although we did not propose any 
adjustments to our policies on incorporating cost measures with SES or 
risk adjustment, we did receive a number of comments which we will 
consider as part of future rulemaking.
(d) Incorporation of Cost Measures With ICD-10 Impacts
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30098), 
we discussed our proposal to assess performance on any measures 
impacted by ICD-10 updates based only on the first 9 months of the 12-
month performance period. Because the total per capita cost and MSPB 
measures include costs from all Medicare Part A and B services, 
regardless of the specific ICD-10 codes that are used on claims, and do 
not assign patients based on ICD-10, we do not anticipate that any 
measures for the cost performance category would be affected by this 
ICD-10 issue during the 2018 MIPS performance period. However, as we 
continue our plans to expand cost measures to incorporate episode-based 
measures, ICD-10 changes could become important. Episode-based measures 
may be opened (triggered) by and may assign services based on ICD-10 
codes. Therefore, a change to ICD-10 coding could have a significant 
effect on an episode-based measure. Changes to ICD-10 codes will be 
incorporated into the measure specifications on a regular basis through 
the measure maintenance process. Please refer to section 
II.C.7.a.(1)(c) of this final rule with comment period for a summary of 
the comments and our response on this issue.
(e) Application of Measures to Non-Patient Facing MIPS Eligible 
Clinicians
    We did not propose changes to the policy we finalized in the CY 
2017 Quality Payment Program final rule (81 FR 77176) that we will 
attribute cost measures to non-patient facing MIPS eligible clinicians 
who have sufficient case volume, in accordance with the attribution 
methodology. Although we did not propose any adjustments to our 
attribution of cost measures to non-patient facing MIPS eligible 
clinicians with sufficient case volume policies, we did receive a few 
comments which we will consider as part of future rulemaking.
    Section 1848(q)(2)(C)(iv) of the Act requires the Secretary to 
consider the circumstances of professional types who typically furnish 
services without patient facing interaction (non-patient facing) when 
determining the application of measures and activities. In addition, 
this section allows the Secretary to apply alternative measures or 
activities to non-patient facing MIPS eligible clinicians that fulfill 
the goals of a performance category. Section 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 involved.
    We believe that non-patient facing clinicians are an integral part 
of the care team and that their services do contribute to the overall 
costs but at this time we believe it better to focus on the development 
of a comprehensive system of episode-based measures which focus

[[Page 53648]]

on the role of patient-facing clinicians. Accordingly, for the 2018 
MIPS performance period, we did not propose alternative cost measures 
for non-patient facing MIPS eligible clinicians or groups. This means 
that non-patient facing MIPS eligible clinicians or groups are unlikely 
to be attributed any cost measures that are generally attributed to 
clinicians who have patient-facing encounters with patients. Therefore, 
we anticipate that, similar to MIPS eligible clinicians or groups that 
do not meet the required case minimums for any cost measures, many non-
patient facing MIPS eligible clinicians may not have sufficient cost 
measures applicable and available to them and would not be scored on 
the cost performance category under MIPS.
    We will continue to explore methods to incorporate non-patient 
facing clinicians into the cost performance category in the future.
(f) Facility-Based Measurement as It Relates to the Cost Performance 
Category
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30123), 
we discussed our proposal to implement section 1848(q)(2)(C)(ii) of the 
Act by assessing clinicians who meet certain requirements and elect 
participation based on the performance of their associated hospital in 
the Hospital VBP Program. We refer readers to section II.C.7.a.(4) of 
this final rule with comment period for full details on the final 
policies related to facility-based measurement, including the measures 
and how the measures are scored, for the cost performance category.
e. Improvement Activity Criteria
(1) Background
    Section 1848(q)(2)(C)(v)(III) of the Act defines an improvement 
activity as an activity that relevant eligible clinician organizations 
and other relevant stakeholders identify as improving clinical practice 
or care delivery, and that the Secretary determines, when effectively 
executed, is likely to result in improved outcomes. Section 
1848(q)(2)(B)(iii) of the Act requires the Secretary to specify 
improvement activities under subcategories for the performance period, 
which must include at least the subcategories specified in section 
1848(q)(2)(B)(iii)(I) through (VI) of the Act, and in doing so to give 
consideration to the circumstances of small practices, and practices 
located in rural areas and geographic health professional shortage 
areas (HPSAs).
    Section 1848(q)(2)(C)(iv) of the Act generally requires the 
Secretary to give consideration to the circumstances of non-patient 
facing individual MIPS eligible clinicians or groups and allows the 
Secretary, to the extent feasible and appropriate, to apply alternative 
measures and activities to such individual MIPS eligible clinicians and 
groups.
    Section 1848(q)(2)(C)(v) of the Act required the Secretary to use a 
request for information (RFI) to solicit recommendations from 
stakeholders to identify improvement activities and specify criteria 
for such improvement activities, and provides that the Secretary may 
contract with entities to assist in identifying activities, specifying 
criteria for the activities, and determining whether individual MIPS 
eligible clinicians or groups meet the criteria set. For a detailed 
discussion of the feedback received from the MIPS and APMs RFI, see the 
CY 2017 Quality Payment Program 2017 final rule (81 FR 77177).
    In the CY 2017 Quality Payment Program final rule (81 FR 77178), we 
defined improvement activities at Sec.  414.1305 as an activity that 
relevant MIPS eligible clinicians, organizations and other relevant 
stakeholders identify as improving clinical practice or care delivery 
and that the Secretary determines, when effectively executed, is likely 
to result in improved outcomes.
    In the CY 2017 Quality Payment Program final rule (81 FR 77199), we 
solicited comments on activities that would advance the usage of health 
IT to support improvement activities for future consideration. Please 
refer to the CY 2018 Quality Payment Program proposed rule (82 FR 
30052) for a full discussion of the public comments we received in 
response to the CY 2017 Quality Payment Program final rule and our 
responses provided on activities that would advance the usage of health 
IT to support improvement activities.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30052), 
we sought comment on how we might provide flexibility for MIPS eligible 
clinicians to effectively demonstrate improvement through health IT 
usage while also measuring such improvement for future consideration. 
We received many comments on this topic and will take them into 
consideration for future rulemaking.
(2) Contribution to the Final Score
(i) Patient-Centered Medical Home
    In the CY 2017 Quality Payment Program final rule (81 FR 77179 
through 77180), we finalized at Sec.  414.1355 that the improvement 
activities performance category would account for 15 percent of the 
final score. We also finalized at Sec.  414.1380(b)(3)(iv) criteria for 
recognition as a certified patient-centered medical home or comparable 
specialty practice. Since then, it has come to our attention that the 
common terminology utilized in the general medical community for 
``certified'' patient-centered medical home is ``recognized'' patient-
centered medical home.
    Therefore, in order to provide clarity, in the CY 2018 Quality 
Payment Program proposed rule (82 FR 30052), we proposed that the term 
``recognized'' be accepted as equivalent to the term ``certified'' when 
referring to the requirements for a patient-centered medical home to 
receive full credit for the improvement activities performance category 
for MIPS. Specifically, we proposed to revise Sec.  414.1380(b)(3)(iv) 
to provide that a MIPS eligible clinician or group in a practice that 
is certified or recognized as a patient-centered medical home or 
comparable specialty practice, as determined by the Secretary, receives 
full credit for performance on the improvement activities performance 
category. A practice is certified or recognized as a patient-centered 
medical home if it meets any of the criteria specified under Sec.  
414.1380(b)(3)(iv).
    We invited public comment on this proposal.
    Comment: A few commenters supported the proposed expansion of the 
patient-centered medical home definition, to include both medical homes 
that are ``certified'' and those that are ``recognized.'' These 
commenters noted that inclusion of both terms aligns with the 
terminology used by various organizations and states that have patient-
centered medical home programs that may be eligible for full credit in 
the improvement activities performance category.
    Response: We thank the commenters for their support.
    Comment: One commenter stated that in the CY 2017 Quality Payment 
Program final rule, the documented recognition as a patient-centered 
medical home from an accredited body combined with continual 
improvements was listed as already receiving credit in the improvement 
activity performance category.
    Response: We believe the commenter is referring to our discussion 
in the CY 2017 Quality Payment Program final rule (81 FR 77179 through 
77180), where we finalized at Sec.  414.1380 an expanded definition of 
what is acceptable for recognition as a certified-

[[Page 53649]]

patient centered medical home or comparable specialty practice. We 
recognized a MIPS eligible clinician or group as being a certified 
patient-centered medical home or comparable specialty practice if they 
have achieved certification or accreditation as such from a national 
program, or they have achieved certification or accreditation as such 
from a regional or state program, private payer or other body that 
certifies at least 500 or more practices for patient-centered medical 
home accreditation or comparable specialty practice certification. In 
the CY 2018 Quality Payment Program proposed rule, we did not propose 
any substantive changes to that definition. However, for the sake of 
clarity we proposed that we will accept the designation of 
``recognized'' as equivalent to the designation of ``certified'' when 
referring to the requirements for a patient-centered medical home or 
comparable specialty practice to receive full credit for the 
improvement activities performance category for MIPS and also to update 
Sec.  414.1380(b)(3)(iv) to reflect this. Our intention behind this 
proposal was to reflect common terminology utilized in the general 
medical community--that ``certified'' patient-centered medical home is 
equivalent to ``recognized'' patient-centered medical home. A practice 
is certified or recognized as a patient-centered medical home if it 
meets any of the criteria specified under Sec.  414.1380(b)(3)(iv).
    Comment: Several commenters provided comments that were not related 
to our proposal to accept the designation of ``recognized'' as 
equivalent to the designation of ``certified'' when referring to the 
requirements for a patient-centered medical home or comparable 
specialty practice to receive full credit for the improvement 
activities performance category for MIPS. They are summarized here. 
Some commenters recommended that CMS consider other models as patient-
centered medical homes for full credit in this performance category. 
These commenters suggested that CMS consider full credit to those MIPS 
eligible clinicians and groups participating in models such as a 
Patient Centered Medical Neighborhood (PCMN), participation in a 
Certified Community Behavioral Health Clinic (CCBHC) or a Medicaid 
Section 2703 Health Home, or Blue Distinction[supreg] Total Care. Other 
commenters suggested that CMS establish a policy to offer full auto-
credit to any practice that achieves National Committee for Quality 
Assurance (NCQA) recognition by December 31st of a given performance 
year, since NCQA requires that practices seeking patient-centered 
medical home and patient-centered specialty practice (PCSP) recognition 
perform the appropriate activities for a minimum of 90 days. Further, 
these commenters recommended that this policy should extend to any 
other approved patient-centered medical home programs that use a 90-day 
look-back period.
    Response: We acknowledge the commenter's suggestions that we 
consider additional models as patient-centered medical homes for full 
credit in this performance category. In the CY 2017 Quality Payment 
Program final rule (81 FR 77180), we previously stated that we 
recognize a MIPS eligible clinician or group as being a certified 
patient-centered medical home or comparable specialty practice if they 
have achieved certification or accreditation as such from a national 
program, or they have achieved certification or accreditation as such 
from a regional or state program, private payer or other body that 
certifies at least 500 or more practices for patient-centered medical 
home accreditation or comparable specialty practice certification. We 
went on to state that examples of nationally recognized accredited 
patient-centered medical homes are: (1) The Accreditation Association 
for Ambulatory Health Care; (2) the National Committee for Quality 
Assurance (NCQA) Patient-Centered Medical Home; (3) The Joint 
Commission Designation; or (4) the Utilization Review Accreditation 
Commission (URAC) (81 FR 77180). We finalized that the criteria for 
being a nationally recognized accredited patient-centered medical home 
are that it must be national in scope and must have evidence of being 
used by a large number of medical organizations as the model for their 
patient-centered medical home (81 FR 77180). We also stated that we 
will also provide full credit for the improvement activities 
performance category for a MIPS eligible clinician or group that has 
received certification or accreditation as a patient-centered medical 
home or comparable specialty practice from a national program or from a 
regional or state program, private payer, or other body that 
administers patient-centered medical home accreditation and certifies 
500 or more practices for patient-centered medical home accreditation 
or comparable specialty practice certification (81 FR 77180). We note, 
however, that in the CY 2018 Quality Payment Program proposed rule we 
did not propose any changes to the definition of what is acceptable for 
recognition as a certified patient-centered medical home or comparable 
specialty practice that we finalized in the CY 2017 Quality Payment 
Program final rule (81 FR 77180) and codified under Sec.  
414.1380(b)(3)(iv). Without more information, we cannot provide 
information as to whether the suggested entities fall within our 
previously established definition above. Furthermore, while we are not 
considering any changes to this definition and criteria for the CY 2018 
performance period, we may consider commenters' suggestions as we craft 
policy for future rulemaking. Moreover, we would like to make clear 
that credit is not automatically granted; MIPS eligible clinicians and 
groups must attest in order to receive the credit (81 FR 77181) which 
is codified at Sec.  414.1360.
    Final Action: After consideration of the public comments received, 
we are finalizing, as proposed, our proposals: (1) That the term 
``recognized'' be accepted as equivalent to the term ``certified'' when 
referring to the requirements for a patient-centered medical home to 
receive full credit for the improvement activities performance category 
for MIPS; and (2) to update Sec.  414.1380(b)(3)(iv) to reflect this 
change.
(ii) Weighting of Improvement Activities
    As previously explained in the CY 2017 Quality Payment Program 
final rule (81 FR 77194), we believe that high weighting should be used 
for activities that directly address areas with the greatest impact on 
beneficiary care, safety, health, and well-being. In the CY 2017 
Quality Payment Program final rule (81 FR 77198), we requested 
commenters' specific suggestions for additional activities or 
activities that may merit additional points beyond the ``high'' level 
for future consideration.
    Comment: Several commenters urged CMS to increase the overall 
number of high-weighted activities in this performance category. Some 
commenters recommended additional criteria for designating high-
weighted activities, such as an improvement activity's impact on 
population health, medication adherence, and shared decision-making 
tools, and encouraged CMS to be more transparent in our weighting 
decisions. Several commenters recommended that CMS weight registry-
related activities as high, and suggested that we award individual MIPS 
eligible clinicians and groups in APMs full credit in this performance 
category. The commenters also offered many recommendations for changing

[[Page 53650]]

current medium-weighted activities to high and offered many specific 
suggestions for new high-weighted improvement activities.
    Response: After review and consideration of comments in the CY 2017 
Quality Payment Program final rule, while we did not propose changes to 
our approach for weighting improvement activities in the CY 2018 
Quality Payment Program proposed rule (82 FR 30052), we will take the 
additional criteria suggested by commenters for designating high-
weighted activities into consideration in future rulemaking. We did 
however, propose new, high-weighted as well as new medium weighted 
activities, in Table F in the Appendix of the proposed rule. We refer 
readers to Table F in the Appendix of this final rule with comment 
period where we are finalizing new activites, and Table G in the same 
Appendix where we are finalizing changes to existing improvement 
activities.
    For MIPS eligible clinicians participating in MIPS APMs, in the CY 
2017 Quality Payment Program final rule (81 FR 77185) we finalized a 
policy to reduce reporting burden through the APM scoring standard for 
this performance category to recognize improvement activities work 
performed through participation in MIPS APMs. This policy is codified 
at Sec.  414.1370(g)(3), and we refer readers to the CY 2017 Quality 
Payment Program final rule for further details on reporting and scoring 
this performance category under the APM Scoring Standard (81 FR 77259 
through 77260). In the CY 2018 Quality Payment Program proposed rule, 
we did not propose any changes to these policies.
    We received many comments on this topic and will take them into 
consideration for future rulemaking.
(3) Improvement Activities Data Submission Criteria
(a) Submission Mechanisms
(i) Generally
    In the CY 2017 Quality Payment Program final rule (81 FR 77180), we 
discussed that for the transition year of MIPS, we would allow for 
submission of data for the improvement activities performance category 
using the qualified registry, EHR, QCDR, CMS Web Interface, and 
attestation data submission mechanisms through attestation. 
Specifically, in the CY 2017 Quality Payment Program final rule (81 FR 
77180), we finalized a policy that regardless of the data submission 
method, with the exception of MIPS eligible clinicians in MIPS APMs, 
all individual MIPS eligible clinicians or groups must select 
activities from the Improvement Activities Inventory. In addition, we 
codified at Sec.  414.1360, that for the transition year of MIPS, all 
individual MIPS eligible clinicians or groups, or third party 
intermediaries such as health IT vendors, QCDRs and qualified 
registries that submit on behalf of an individual MIPS eligible 
clinician or group, must designate a ``yes'' response for activities on 
the Improvement Activities Inventory. We also codified at Sec.  
414.1360 that in the case where an individual MIPS eligible clinician 
or group is using a health IT vendor, QCDR, or qualified registry for 
their data submission, the individual MIPS eligible clinician or group 
will validate the improvement activities that were performed, and the 
health IT vendor, QCDR, or qualified registry would submit on their 
behalf.
    We would like to maintain stability in the Quality Payment Program 
and continue these policies into future years. In the CY 2018 Quality 
Payment proposed rule (82 FR 30053), we proposed to update Sec.  
414.1360 for the transition year of MIPS and future years, to reflect 
that all individual MIPS eligible clinicians or groups, or third party 
intermediaries such as health IT vendors, QCDRs and qualified 
registries that submit on behalf of an individual MIPS eligible 
clinician or group, must designate a ``yes'' response for activities on 
the Improvement Activities Inventory. We note that these are the same 
requirements as previously codified for the transition year; 
requirements for the transition year remain unchanged. We merely 
proposed to extend the same policies for future years.
    In addition, in the case where an individual MIPS eligible 
clinician or group is using a health IT vendor, QCDR, or qualified 
registry for their data submission, we proposed that the MIPS eligible 
clinician or group will certify all improvement activities were 
performed and the health IT vendor, QCDR, or qualified registry would 
submit on their behalf (82 FR 30053). In summary, we proposed to 
continue our previously established policies for future years and to 
generally apply our group policies to virtual groups. Furthermore, we 
refer readers to the CY 2018 Quality Payment Program proposed rule at 
(82 FR 30029) and section II.C.4.d. of this final rule, where we are 
finalizing to generally apply our group policies to virtual groups.
    While we previously codified at Sec.  414.1325(d) in the CY 2017 
Quality Payment Program final rule that individual MIPS eligible 
clinicians and groups may only use one submission mechanism per 
performance category, (81 FR 77275), in section II.C.6.a.(1) of this 
final rule with comment period, we are finalizing our proposal, with 
modification, to revise Sec.  414.1325(d) for purposes of the 2021 MIPS 
payment year and future years to allow individual MIPS eligible 
clinicians and groups to submit measures and activities, as applicable, 
via as many submission mechanisms as necessary to meet the requirements 
of the quality, improvement activities, or advancing care information 
performance categories. We refer readers to section II.C.6.a.(1) of 
this final rule with comment period for discussion of this proposal as 
finalized.
    We also included a designation column in the Improvement Activities 
Inventory at Table H in the Appendix of the CY 2017 Quality Payment 
Program final rule (81 FR 77817) that indicated which activities 
qualified for the advancing care information bonus codified at Sec.  
414.1380. In future updates to the Improvement Activities Inventory, we 
intend to continue to indicate which activities qualify for the 
advancing care information performance category bonus.
    We invited public comment on our proposals.
    Comment: A few commenters expressed support for our proposal that 
for the transition year of MIPS and future years, all individual MIPS 
eligible clinicians or groups, or third party intermediaries such as 
health IT vendors, QCDRs, and qualified registries that submit on 
behalf of an individual MIPS eligible clinician or group, must 
designate a ``yes'' response for activities on the Improvement 
Activities Inventory, and that where an individual MIPS eligible 
clinician or group is using a health IT vendor, QCDR, or qualified 
registry for their data submission, the MIPS eligible clinician or 
group must certify all improvement activities were performed and the 
health IT vendor, QCDR, or qualified registry would submit on their 
behalf.
    Response: We thank the commenters for their support. We realize the 
way the proposal was worded may have caused some potential confusion. 
Therefore, we are clarifying here that our proposal merely extends the 
same requirements, as previously codified for the transition year, to 
future years; requirements for the transition year remain unchanged.
    Comment: One commenter urged CMS to refer to registries more 
broadly, rather than using the term ``QCDR,'' noting that many 
qualified registries are in use by clinicians, even though these may 
not have received official QCDR

[[Page 53651]]

status for one reason or another. Another commenter requested that CMS 
consider allowing other third parties that may be collecting 
information that is indicative of completion of an improvement activity 
to submit data to CMS, suggesting that for example, an organization 
that awards continuing medical education (CME) credits that qualify as 
improvement activities could submit a list of MIPS eligible clinicians 
who received qualifying CME credit directly to CMS.
    Response: We note that the terms ``qualified registry'' and 
``QCDR'' are defined terms for the purposes of MIPS, as codified at 
Sec.  414.1400. We refer readers to section II.C.10. of this final rule 
with comment period for a detailed discussion of third party 
intermediaries. While we recognize that there are other registries that 
are not considered MIPS qualified registry or QCDRs, those registries 
have the option to become a MIPS QCDR using the process finalized in 
the CY 2017 Quality Payment Program final rule (81 FR 77365), or 
qualify as a MIPS registry using the process finalized at 81 FR 77383 
in that same final rule. If an organization becomes a MIPS qualified 
registry or QCDR then they could submit MIPS data to us.
    Final Action: After consideration of the public comments we 
received, we are finalizing our proposals, with clarification, to 
continue our previously established policies for future years. 
Specifically: (1) For purposes of MIPS Year 2 and future years, MIPS 
eligible clinicians or groups must submit data on MIPS improvement 
activities in one of the following manners: Via qualified registries; 
EHR submission mechanisms; QCDR, CMS Web Interface; or attestation. Our 
proposal language may have potentially caused some confusion, because 
it included the transition year; however, we are clarifying here that 
policies were previously established for that year and remain 
unchanged. We are also finalizing, as proposed: (2) For activities that 
are performed for at least a continuous 90 days during the performance 
period, MIPS eligible clinicians must submit a yes response for 
activities within the Improvement Activities Inventory; and (3) that 
Sec.  414.1360 will be updated to reflect these changes.
(ii) Group Reporting
    In the CY 2017 Quality Payment Program final rule (81 FR 77181), we 
clarified that if one MIPS eligible clinician (NPI) in a group 
completed an improvement activity, the entire group (TIN) would receive 
credit for that activity. In addition, we specified that all MIPS 
eligible clinicians reporting as a group would receive the same score 
for the improvement activities performance category if at least one 
clinician within the group is performing the activity for a continuous 
90 days in the performance period. We refer readers to section 
II.C.4.d. of this final rule with comment period, where we are 
finalizing to generally apply our group policies to virtual groups. We 
did not propose any changes to our group reporting policies in the 
proposed rule. However, in the CY 2017 Quality Payment Program proposed 
rule (82 FR 30053), we requested comment for future consideration on 
whether we should establish a minimum threshold (for example, 50 
percent) of the clinicians (NPIs) that must complete an improvement 
activity in order for the entire group (TIN) to receive credit in the 
improvement activities performance category in future years. In 
addition, we requested comments for future consideration on recommended 
minimum threshold percentages and whether we should establish different 
thresholds based on the size of the group. In the proposed rule, (82 FR 
30053), we noted that we are concerned that while establishing any 
specific threshold for the percentage of NPIs in a TIN that must 
participate in an improvement activity for credit will incentivize some 
groups to move closer to the threshold, it may have the unintended 
consequence of incentivizing groups who are exceeding the threshold to 
gravitate back toward the threshold. Therefore, we requested comments 
for future consideration on how to set this threshold while maintaining 
the goal of promoting greater participation in an improvement activity.
    Additionally, we noted in the CY 2017 Quality Payment Program final 
rule (81 FR 77197) that we intended, in future years, to score the 
improvement activities performance category based on performance and 
improvement, rather than simple attestation. In the CY 2018 Quality 
Payment Program proposed rule (82 FR 30053), we sought comment on how 
we could measure performance and improvement for future consideration; 
we were especially interested in ways to measure performance without 
imposing additional burden on eligible clinicians, such as by using 
data captured in eligible clinicians' daily work.
    We received many comments on these topics and will take them into 
consideration as we craft for future policies.
(b) Submission Criteria
(i) Background
    In the CY 2017 Quality Payment Program final rule (81 FR 77185), we 
finalized at Sec.  414.1380 to set the improvement activities 
submission criteria under MIPS, to achieve the highest potential score, 
at two high-weighted improvement activities or four medium-weighted 
improvement activities, or some combination of high and medium-weighted 
improvement activities. While the minimum reporting period for one 
improvement activity is 90 days, the maximum frequency with which an 
improvement activity may be reported would be once during the 12-month 
performance period (81 FR 77185). In addition, we refer readers to 
section II.C.4.d. of this final rule with comment period, where we are 
finalizing to generally apply group policies to virtual groups.
    In the CY 2017 Quality Payment Program final rule (81 FR 77185), we 
established exceptions to the above for: Small practices; practices 
located in rural areas; practices located in geographic HPSAs; non-
patient facing individual MIPS eligible clinicians or groups; and 
individual MIPS eligible clinicians and groups that participate in a 
MIPS APM or a patient-centered medical home submitting in MIPS. 
Specifically, for individual MIPS eligible clinicians and groups that 
are small practices, practices located in rural areas or geographic 
HPSAs, or non-patient facing individual MIPS eligible clinicians or 
groups, to achieve the highest score, one high-weighted or two medium-
weighted improvement activities are required (81 FR 77185). For these 
individual MIPS eligible clinicians and groups, in order to achieve 
one-half of the highest score, one medium-weighted improvement activity 
is required (81 FR 77185).
    In the CY 2017 Quality Payment Program final rule (81 FR 77185), we 
finalized that under the APM scoring standard, all clinicians 
identified on the Participation List of an APM receive at least one-
half of the highest score applicable to the MIPS APM. To develop the 
improvement activities score assigned to each MIPS APM, we compare the 
requirements of the specific MIPS APM with the list of activities in 
the Improvement Activities Inventory and score those activities in the 
same manner that they are otherwise scored for MIPS eligible clinicians 
(81 FR 77185). If by our assessment the MIPS APM does not receive the 
maximum improvement activities performance category score then the APM 
entity can submit additional

[[Page 53652]]

improvement activities (81 FR 77185). All other individual MIPS 
eligible clinicians or groups that we identify as participating in APMs 
that are not MIPS APMs will need to select additional improvement 
activities to achieve the improvement activities highest score (81 FR 
77185). We did not propose any changes to these policies; we refer 
readers to section II.C.6.g. of this final rule with comment period for 
further discussion of the APM scoring standard.
    We received many comments on this topic and will take them into 
consideration for future rulemaking.
(ii) Patient-Centered Medical Homes or Comparable Specialty Practices
    In the CY 2017 Quality Payment Program final rule (81 FR 77185), we 
finalized at Sec.  414.1380(b)(3)(iv) to provide full credit for the 
improvement activities performance category, as required by law, for an 
individual MIPS eligible clinician or group that has received 
certification or accreditation as a patient-centered medical home or 
comparable specialty practice from a national program or from a 
regional or state program, private payer or other body that administers 
patient-centered medical home accreditation and certifies 500 or more 
practices for patient-centered medical home accreditation or comparable 
specialty practice certification, or for an individual MIPS eligible 
clinician or group that is a participant in a medical home model. We 
noted in the CY 2017 Quality Payment Program final rule (81 FR 77178) 
that practices may receive this designation at a practice level and 
that TINs may be comprised of both undesignated practices and 
designated practices. We finalized at Sec.  414.1380(b)(3)(viii) that 
to receive full credit as a certified patient-centered medical home or 
comparable specialty practice, a TIN that is reporting must include at 
least one practice site which is a certified patient-centered medical 
home or comparable specialty practice (81 FR 77178). We also indicated 
that we would continue to have more stringent requirements in future 
years, and would lay the groundwork for expansion towards continuous 
improvement over time (81 FR 77189).
    We received many comments on the CY 2017 Quality Payment Program 
final rule regarding our transition year policy that only one practice 
site within a TIN needs to be certified as a patient-centered medical 
home for the entire TIN to receive full credit in the improvement 
activities performance category. While several commenters supported our 
transition year policy, others disagreed and suggested to move to a 
more stringent requirement in future years while still offering some 
flexibility. We refer readers to the CY 2017 Quality Payment Program 
final rule (81 FR 77180 through 77182) for the details of those 
comments and our responses. In response to these comments, in the CY 
2018 Quality Payment Program proposed rule (82 FR 30054), we proposed 
to revise Sec.  414.1380(b)(3)(x) to provide that for the 2020 MIPS 
payment year and future years, to receive full credit as a certified or 
recognized patient-centered medical home or comparable specialty 
practice, at least 50 percent of the practice sites within the TIN must 
be recognized as a patient-centered medical home or comparable 
specialty practice. This is an increase to the previously established 
requirement codified at Sec.  414.1380(b)(3) in the CY 2017 Quality 
Payment Program final rule (81 FR 77178) that only one practice site 
within a TIN needs to be certified as a patient-centered medical home. 
We chose not to propose to require that every site be certified, 
because that could potentially be overly restrictive given that some 
sites within a TIN may be in the process of being certified as patient-
centered medical homes. We believe a 50 percent threshold is 
achievable, and is supported by a study of physician-owned primary care 
groups in a recent Annals of Family Medicine article (Casalino, et al., 
2016) http://www.annfammed.org/content/14/1/16.full. For nearly all 
groups in this study (sampled with variation in size and geographic 
area), at least 50 percent of the practice sites within the group had a 
medical home designation.\2\ If the group is unable to meet the 50 
percent threshold, then the individual MIPS eligible clinician may 
choose to receive full credit as a certified patient-centered medical 
home or comparable specialty practice by reporting as an individual for 
all performance categories. In addition, we refer readers to section 
II.C.4.d. of this final rule with comment period, where we are 
finalizing to generally apply our group policies to virtual groups. 
Further, in the proposed rule, we welcomed suggestions on an 
appropriate threshold for the number of NPIs within the TIN that must 
be recognized as a certified patient-centered medical home or 
comparable specialty practice to receive full credit in the improvement 
activities performance category.
---------------------------------------------------------------------------

    \2\ Casalino LP, Chen MA, Staub CT, Press MJ, Mendelsohn JL, 
Lynch JT, Miranda Y. Large independent primary care medical groups. 
Ann Fam Med. 2016;14(1):16-25.
---------------------------------------------------------------------------

    In the CY 2018 QPP proposed rule (82 FR 30054 through 55) we 
invited public comments on our proposals to revise Sec.  
414.1380(b)(3)(x) to provide that for the 2020 MIPS payment year and 
future years, to receive full credit as a certified or recognized 
patient-centered medical home or comparable specialty practice, at 
least 50 percent of the practice sites within the TIN must be 
recognized as a patient-centered medical home or comparable specialty 
practice. However, we are correcting here that we intended to add Sec.  
414.1380(b)(3)(x) as a new provision, not revise it. This was an 
inadvertent typographical error. The following is a summary of the 
public comments received and our responses.
    Comment: Several commenters supported CMS's proposal to raise the 
threshold to 50 percent for the number of practice sites that must be 
recognized within a TIN to receive full credit in this performance 
category as a patient-centered medical home or comparable specialty. 
These commenters noted that the proposal strikes an appropriate balance 
between requiring a TIN to show substantial accomplishment before 
receiving full credit in this performance category and acknowledging 
that it may be infeasible for every practice site within a TIN to 
achieve this recognition. One commenter urged CMS to accept data feeds 
from accrediting bodies so that we can move to requiring 100 percent of 
practice sites within a TIN to achieve recognition in order to receive 
full credit in this performance category.
    Response: We appreciate the support and agree that establishing a 
50 percent threshold strikes an appropriate balance. In addition, we 
appreciate the comment regarding accepting data feeds from accrediting 
bodies and will explore this idea, including whether it is technically 
feasible, as we craft future policy.
    Comment: Another commenter supported the proposal, but suggested 
that it would be most logical to define the threshold as 50 percent of 
the primary care sites for TINs with both specialty and primary care, 
and for groups with both primary care and specialty only sites, the 
denominator for the threshold should be the number of primary care.
    Response: It is important to note that our criteria for patient-
centered medical homes include specialty sites as well, not just 
primary care. We do not believe it is appropriate to restrict patient-
centered medical home designation to primary care sites only. Based on 
a survey of patient-centered medical homes accrediting organizations, 
named in the Annals of Family Medicine article

[[Page 53653]]

2017 (Casalino, et al., 2016) cited above in our proposal, only one 
specifically requires that practices be primary care, and another 
offers specialty-specific patient-centered medical homes recognition. 
Therefore, it is reasonable to assume that specialty practices could 
attain patient-centered medical homes recognition through multiple 
accrediting organizations along with their primary care sites if they 
choose to. Overall, we believe that setting the patient-centered 
medical home group threshold at 50 percent of the group is achievable 
and it is our goal to encourage TINs to have more practice sites 
undergo transformation.
    Comment: Several commenters opposed CMS's proposal to raise the 
threshold to 50 percent for the number of practice sites that must be 
recognized within a TIN to receive full credit in this performance 
category as a patient-centered medical home or comparable specialty, 
expressing concern that it is a significant change from the first year 
of the program, and urging CMS to continue to provide flexibility in 
this area or gradually increase the threshold in future years.
    Several commenters expressed concern that the proposed threshold is 
premature and may interfere with their ability to report participation 
in an improvement activity that may be unique to their specialty group 
or discourage participation by some clinicians in the medical home 
models altogether.
    Other commenters expressed concern that CMS's proposed policy fails 
to account for the effort and investment required to achieve this 
designation, and fails to account for how the work of those sites that 
do achieve such recognition impacts specialty clinics within a TIN by 
ensuring coordinated primary care for patients as those practice sites 
refer patients needing specialized care who cannot be managed by 
primary care. Some commenters recommended that CMS consider 
alternatives to our proposal. A few commenters recommended a threshold 
of 2 or more practice sites, or beginning with a lower threshold, such 
as 33 percent. One commenter suggested that CMS instead consider 
awarding prorated credit for the entire TIN that is in proportion to 
the percentage of the TIN that is a patient-centered medical home or 
comparable specialty. For example, for one practice site that is a 
patient-centered medical home out of five sites under the same TIN, 
this practice would receive 20 percent of the 100 percent credit for 
the performance category score, and eligible clinicians in the other 
four sites within the TIN would need to demonstrate other improvement 
activities. Although MIPS eligible clinicians may choose to receive 
full credit by reporting as an individual clinician, one commenter 
noted that this is not a reasonable alternative due to the complexity 
and burden required to do so as part of a large multi-specialty group. 
This commenter suggested that before proceeding with this policy, CMS 
should determine an alternative that allows a portion of a group under 
one TIN to report as a separate subgroup on measures and activities 
that are more applicable to that subgroup. This commenter suggested 
that alternatively, CMS could incorporate thresholds into improvement 
activities, consider a variety of thresholds (for example, clinicians 
participating, target population included, entire practice included, 
etc.) and adjust the thresholds based on the type of improvement 
activity. Another commenter suggested that CMS equate this threshold 
with the credit received, giving the example that if 70 percent of NPIs 
within a TIN are performing an improvement activity, then that group 
should get 70 percent credit toward that improvement activity score. 
Commenters suggested that this addresses the possibility of a decline 
in further improvement once the set threshold is achieved.
    Response: We disagree with the commenters who oppose increasing the 
threshold to 50 percent of the group practice sites to receive patient-
centered medical home designation. Currently, only one practice site in 
a TIN with multiple practice sites is required for full credit as a 
patient-centered medical home. We recognized that the transition year 
was the first time MIPS eligible clinicians or groups would be measured 
on the quality improvement work on a national scale. Therefore, we 
approached the improvement activities performance category with these 
principles in mind along with the overarching principle for the MIPS 
program that we are building a process that will have increasingly more 
stringent requirements over time. We noted in the CY 2017 Quality 
Payment Program final rule (81 FR 77188 through 77189) that the 
baseline requirements that would continue to have more stringent 
requirements in future years, and that we were laying the groundwork 
for expansion towards continuous improvement over time. We recognized 
that quality improvement is a critical aspect of improving the health 
of individuals and the health care delivery system overall. We have 
provided great flexibility during the transition year and believe it is 
time to increase this threshold to encourage TINs to increase their 
number of patient-centered medical homes. We do not believe that only 
one MIPS eligible clinician should represent the entire group going 
forward; and accordingly, do not believe one MIPS eligible clinician's 
patient-centered medical home status should qualify the entire group to 
receive the maximum improvement activity performance category score (15 
points) toward their final score beyond the transition year. In 
addition, as discussed in our proposal above, we determined that a 50 
percent threshold would be appropriate, because we believe it is an 
achievable goal and it is supported by a study of physician-owned 
primary care groups in a recent Annals of Family Medicine article, in 
which nearly all groups of varying sizes in this study (sampled with 
variation in size and geographic area) have 50 percent or more of the 
practice sites within a group being an NCQA patient-centered medical 
home.
    In response to the commenters who believed that the proposed 
threshold may interfere with their ability to report participation in 
an improvement activity that may be unique to their specialty group, if 
those specialty groups decided to use patient-centered medical home 
recognition as their credit for the improvement activities performance 
category, those specialty groups would not be able to report on 
improvement activities unique to their specialties. We refer commenters 
to our proposal above where we state that if the group is unable to 
meet the 50 percent threshold, then the individual MIPS eligible 
clinicians may choose to receive full credit as a recognized or 
certified patient-centered medical home, or comparable specialty 
practice, as an individual for all performance categories (82 FR 
30054). To emphasize this point, specialty clinicians could either be 
recognized as a comparable specialty practice under the patient-
centered medical home designation, which would reflect the specialty 
care they provide, or they could report on improvement activities that 
may be unique to their specialty group as individual reporters. 
Therefore, we do not believe that setting the patient-centered medical 
home threshold at 50 percent would interfere with a group's ability to 
report other specialty specific improvement activities. We believe that 
the suggestion that we use a threshold of 2 or more practice sites, 
instead of 50 percent might discourage large medical groups from 
investing in patient-centered medical home transformation more broadly, 
because many large

[[Page 53654]]

medical groups may have ten practice sites, and having only 2 sites 
recognized as patient-centered medical homes would mean a very 
different investment for a practice with 3 sites than it would for a 
practice with 30 sites. We also disagree that a threshold of 33 percent 
is appropriate, because the literature (Casalino, et al., 2016), as 
cited in our proposal, demonstrated that a 50 percent target is 
achievable and we have seen a subset of large, multi-specialty medical 
groups from across the country that have already surpassed this target. 
We also believe that finalizing a proportion lower than 50 percent of 
practice sites would unfairly discredit practices that have greater 
integration and required a significant investment. In addition, using a 
pro-rated approach as suggested by a commenter brings significant added 
complexity and burden, for which we do not believe outweighs the 
benefits.
    Comment: Several commenters indicated that large multispecialty 
practices, such as academic medical centers, have a large number of 
specialists; therefore, it is unlikely that 50 percent of the practice 
sites under their TIN would be recognized as medical homes. Commenters 
cautioned that excluding these medical homes from getting credit while 
other practices get full credit is likely to discourage practice 
locations from seeking this designation.
    Response: Regarding commenters who suggested that large 
multispecialty practices, such as academic medical centers with a large 
number of specialists would be unlikely to have 50 percent of the 
practice sites under their TIN recognized as medical homes, we want to 
raise the threshold to encourage greater transition such that there a 
meaningful investment in transforming their practice sites. Having 50 
percent of their sites being recognized as patient-centered medical 
homes represents a significant investment toward practice 
transformation that is achievable and supported by the literature. As 
cited in our proposal (Casalino, et al., 2016), studies have 
demonstrated that a 50 percent target is achievable and we have seen a 
subset of large, multi-specialty medical groups from across the country 
that have already surpassed this target. In addition, if an academic 
medical center has numerous sites, and only one is a patient-centered 
medical home, we do not believe that represent the same degree of 
investment in practice transformation as a TIN with 50 percent or more 
of the practice sites being recognized medical homes, because because 
having only 2 sites recognized as patient-centered medical homes would 
mean a very different investment for a practice with 3 sites than it 
would for a practice with 30 sites.
    Comment: Another commenter suggested that CMS use the CMS Study on 
Burden Associated with Quality Reporting that is discussed in section 
II.C.6.e.(9) of this final rule with comment period to solicit input 
from stakeholders about how to assess thresholds of participation, 
score practices on performance, and assess improvement.
    Response: As discussed in the CY 2017 Quality Payment Program final 
rule (81 FR 77195) the CMS Study on Burden Associated with Quality 
Reporting goals are to see whether there will be improved outcomes, 
reduced burden in reporting, and enhancements in clinical care by 
selected MIPS eligible clinicians desiring:
     A more data driven approach to quality measurement.
     Measure selection unconstrained by a CEHRT program or 
system.
     Improving data quality submitted to CMS.
     Enabling CMS get data more frequently and provide feedback 
more often.
    We do not believe the CMS Study on Burden Associated with Quality 
Reporting is the appropriate vehicle to assess thresholds of 
participation, score practices on performance, and assess improvement. 
We will, however, take these comments into consideration as we craft 
future policies.
    Comment: One commenter requested that CMS more clearly define the 
term ``practice'' used in the CY 2018 Quality Payment proposed rule (82 
FR 30054) and clarify, for example, whether ``practice'' means a 
physical location where services are delivered or the administrative 
address, among other things, and urged CMS to define this term in a way 
that includes as many individual MIPS eligible clinicians as possible.
    Response: In the CY 2018 Quality Payment Program proposed rule (82 
FR 30054), we proposed to revise Sec.  414.1380(b)(3)(x) to provide 
that for the 2020 MIPS payment year and future years, to receive full 
credit as a certified or recognized patient-centered medical home or 
comparable specialty practice, at least 50 percent of the practice 
sites within the TIN must be recognized as a patient-centered medical 
home or comparable specialty practice. However, we note again that we 
intended to add Sec.  414.1380(b)(3)(x) as a new provision, not revise 
it. This was an inadvertent typographical error. We interpret commenter 
to be referring to our use of the term ``practice sites'' and we agree 
with the commenter that defining this term will reduce ambiguity. In 
response, we are clarifying in this final rule that a practice site is 
the physical location where services are delivered. We are 
operationalizing this definition by using the practice address field 
within the Provider Enrollment, Chain and Ownership System (PECOS). We 
believe this definition is generally acceptable in the medical 
community as a whole, because physical practice locations are a common 
way for primary care to be organized.
    Comment: One commenter stated that the intent of MACRA was to give 
all practices recognized as a patient-centered medical home or 
comparable specialty full credit in the improvement activities 
performance category and that the proposed threshold is not consistent 
with the intent of Congress.
    Response: We disagree with the commenter that our proposal is 
contrary to the intent of Congress. Section 1848(q)(5)(C)(i) of the Act 
specifies that a MIPS eligible clinician or group that is certified or 
recognized as a patient-centered medical home or comparable specialty 
practice, as determined by the Secretary, must be given the highest 
potential score for the improvement activities performance category for 
the performance period. We believe the statute gives the Secretary 
discretion to determine what qualifies as a certified or recognized 
patient-centered medical home or comparable specialty practice. We have 
provided the utmost flexibility by allowing any undesignated practices 
to receive full credit simply by virtue of being in a TIN with one 
designated practice. As discussed in the CY 2017 Quality Payment 
Program final rule (81 FR 30054) for the transition year, that 
practices may receive a patient-centered medical home designation at a 
practice level, and that individual TINs may be composed of both 
undesignated practices and practices that have received a designation 
as a patient-centered medical home (for example, only one practice site 
has received patient-centered medical home designation in a TIN that 
includes five practice sites). In addition, we finalized an expanded 
definition of what is acceptable for recognition as a certified 
patient-centered medical home or comparable specialty practice (81 FR 
77180). We refer readers to Sec.  414.1380(3)(iv) for details. We 
recognized a MIPS eligible clinician or group as being a certified 
patient-centered medical home or comparable specialty practice if they 
have achieved certification or accreditation as such from a national 
program, or they have achieved certification or accreditation as

[[Page 53655]]

such from a regional or state program, private payer or other body that 
certifies at least 500 or more practices for patient-centered medical 
home accreditation or comparable specialty practice certification (81 
FR 77180). Examples of nationally recognized accredited patient-
centered medical homes are: (1) The Accreditation Association for 
Ambulatory Health Care; (2) the National Committee for Quality 
Assurance (NCQA) Patient-Centered Medical Home; (3) The Joint 
Commission Designation; or (4) the Utilization Review Accreditation 
Commission (URAC) (81 FR 77180). We finalized that the criteria for 
being a nationally recognized accredited patient-centered medical home 
are that it must be national in scope and must have evidence of being 
used by a large number of medical organizations as the model for their 
patient-centered medical home (81 FR 77180). We also provided full 
credit for the improvement activities performance category for a MIPS 
eligible clinician or group that has received certification or 
accreditation as a patient-centered medical home or comparable 
specialty practice from a national program or from a regional or state 
program, private payer or other body that administers patient-centered 
medical home accreditation and certifies 500 or more practices for 
patient-centered medical home accreditation or comparable specialty 
practice certification (81 FR 77180). Once a MIPS eligible clinician or 
group is certified or recognized as a patient-centered medical home or 
comparable specialty practice, those clinicians or groups are given the 
full improvement activities score (for example, 40 points) (81 FR 
77180). This policy specifically applies to MIPS eligible groups; 
individual MIPS eligible clinicians may still attest that their 
practice is part of a patient-centered medical home or comparable 
specialty practice as established for the transition year in the CY 
2017 Quality Payment Program final rule (81 FR 77189).
    Final Action: After consideration of the public comments received, 
we are finalizing our proposals with clarification. Specifically, we 
are finalizing that for the 2020 MIPS payment year and future years, to 
receive full credit as a certified or recognized patient-centered 
medical home or comparable specialty practice, at least 50 percent of 
the practice sites within the TIN must be recognized as a patient-
centered medical home or comparable specialty practice. We are 
clarifying that a practice site as is the physical location where 
services are delivered. We are also finalizing to add Sec.  
414.1380(b)(3)(x) to reflect these changes.
(A) CPC+
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30054) 
we stated that we have determined that the Comprehensive Primary Care 
Plus (CPC+) APM design satisfies the requirements to be designated as a 
medical home model, as defined in Sec.  414.1305; and therefore, as 
defined at 81 FR 77178 that states that patient-centered medical homes 
will be recognized if it is a nationally recognized accredited patient-
centered medical home, a Medicaid Medical Home Model, or a Medical Home 
Model, CPC+ APM is also a certified or recognized patient-centered 
medical home for purposes of the improvement activities performance 
category. We have also determined that the CPC+ APM meets the criteria 
to be an Advanced APM. We refer readers to https://qpp.cms.gov/docs/QPP_Advanced_APMs_in_2017.pdf for more information. Participating CPC+ 
practices in the Model must adopt, at a minimum, the certified health 
IT needed to meet the certified EHR technology (CEHRT) definition at 
Sec.  414.1305. In addition, participating CPC+ practices receive 
payments for covered professional services based on quality measures 
comparable to those used in the quality performance category of MIPS, 
and they bear more than a nominal amount of financial risk for monetary 
losses as described at Sec.  414.1415.
    We recognized the possibility that certain practices that applied 
to participate in Round 2 of the CPC+ APM, but were not chosen to 
participate in the model, could potentially be randomized into a CPC+ 
control group. The control group practices would meet all of the same 
eligibility requirements as the CPC+ participating practices (also 
known as the ``intervention group'') but the control group would not 
``participate'' in the APM (for example, undertake the CPC+ care 
delivery activities such as providing 24/7 clinician access, or empanel 
attributed Medicare beneficiaries) or receive any of the CPC+ payments. 
In the CY 2018 Quality Payment Program proposed rule (82 FR 30015), we 
discussed that we believe MIPS eligible clinicians, who are 
participating in the CPC+ APM, whether actively in the intervention 
group or as part of the control group, should therefore receive full 
credit for the improvement activities performance category.
    Accordingly, in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30054 through 30055), we proposed that MIPS eligible clinicians 
in practices randomized to the control group in the CPC+ APM would 
receive full credit as a medical home model, and therefore, a certified 
patient-centered medical home, for the improvement activities 
performance category. In other words, MIPS eligible clinicians who 
attest that they are in practices that have been randomized to the 
control group in the CPC+ APM would receive full credit for the 
improvement activities performance category for each performance period 
in which they are on the Practitioner Roster, the official list of 
eligible clinicians participating in a practice in the CPC+ control 
group (82 FR 30054 through 30055).
    We invited public comment on our proposal. The following is a 
summary of public comments received on this proposal and our response.
    Comment: Several commenters stated that they support recognizing 
CPC+ control group participants as participating in a medical home 
model and receiving full credit for the improvement activities 
performance category. The commenters noted that the focus of these 
practices should be on developing a balance in primary care and 
specialty care focused high-weight improvement activities. One 
commenter stated that the requirements of CPC+ are such that there 
would be a guarantee that participants are carrying out true practice 
improvement activities focused on patient-centered care.
    Response: We thank commenters for their support. As an update, CMS 
has not randomized any practices that will begin participation in CPC+ 
in 2018 into a control group. Because we have not randomized any 
practices into a control group in CPC+ Round 2, we are not finalizing 
our proposal.
    Final Action: After consideration of the public comments we 
received and developments in the CPC+ Model, we are not finalizing our 
proposal as discussed above.
(c) Required Period of Time for Performing an Activity
    In the CY 2017 Quality Payment Program final rule (81 FR 77186), we 
specified at Sec.  414.1360 that MIPS eligible clinicians or groups 
must perform improvement activities for at least 90 consecutive days 
during the performance period for improvement activities performance 
category credit. Activities, where applicable, may be continuing (that 
is, could have started prior to the performance period and are 
continuing) or be adopted in the

[[Page 53656]]

performance period as long as an activity is being performed for at 
least 90 days during the performance period. In the CY 2018 Quality 
Payment Program proposed rule (82 FR 30055), we did not propose any 
changes to the required period of time for performing an activity for 
the improvement activities performance category in the proposed rule. 
We also refer readers to section II.C.4.d. of this final rule with 
comment period, where we are finalizing to generally apply our group 
policies to virtual groups.
    We received many comments on this topic and will take them into 
consideration for future rulemaking.
(4) Application of Improvement Activities to Non-Patient Facing 
Individual MIPS Eligible Clinicians and Groups
    In the CY 2017 Quality Payment Program final rule (81 FR 77187), we 
specified at Sec.  414.1380(b)(3)(vii) that for non-patient facing 
individual MIPS eligible clinicians or groups, to achieve the highest 
score one high-weighted or two medium-weighted improvement activities 
are required. For these individual MIPS eligible clinicians and groups, 
in order to achieve one-half of the highest score, one medium-weighted 
improvement activity is required (81 FR 77187). In the CY 2018 Quality 
Payment Program proposed rule (82 FR 30055), we did not propose any 
changes to the application of improvement activities to non-patient 
facing individual MIPS eligible clinicians and groups for the 
improvement activities performance category.
    We received a few comments on this topic and will take them into 
consideration for future rulemaking.
(5) Special Consideration for Small, Rural, or Health Professional 
Shortage Areas Practices
    In the CY 2017 Quality Payment Program final rule (81 FR 77188), we 
finalized at Sec.  414.1380(b)(3)(vii) that one high-weighted or two 
medium-weighted improvement activities are required for individual MIPS 
eligible clinicians and groups that are small practices or located in 
rural areas, or geographic HPSAs, to achieve full credit. In addition, 
we specified at Sec.  414.1305 that a rural area means ZIP codes 
designated as rural, using the most recent HRSA Area Health Resource 
File data set available (81 FR 77012). Lastly, in the CY 2017 Quality 
Payment Program final rule (81 FR 77539 through 77540), we codified the 
following definitions at Sec.  414.1305: (1) Small practices is defined 
to mean practices consisting of 15 or eligible clinicians; and (2) 
Health Professional Shortage Areas (HPSA) refers to areas as designated 
under section 332(a)(1)(A) of the Public Health Service Act. In the CY 
2018 Quality Payment Program proposed rule (82 FR 30055), we did not 
propose any changes to the special consideration for small, rural, or 
health professional shortage areas practices for the improvement 
activities performance category in the proposed rule.
    We received many comments on this topic and will take them into 
consideration for future rulemaking.
(6) Improvement Activities Subcategories
    In the CY 2017 Quality Payment Program final rule (81 FR 77190), we 
finalized at Sec.  414.1365 that the improvement activities performance 
category will include the subcategories of activities provided at 
section 1848(q)(2)(B)(iii) of the Act. In addition, we finalized (81 FR 
77190) at Sec.  414.1365 the following additional subcategories: 
Achieving Health Equity; Integrated Behavioral and Mental Health; and 
Emergency Preparedness and Response. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30055), we did not propose any changes to 
the improvement activities subcategories for the improvement activities 
performance category in the proposed rule.
    We received a few comments on this topic and will take them into 
consideration for future rulemaking.
(7) Improvement Activities Inventory
    We refer readers to Table H in the Appendix of the CY 2017 Quality 
Payment Program final rule (81 FR 77817) for our previously finalized 
Improvement Activities Inventory for the transition year of MIPS and 
future years. In this final rule with comment period, we are finalizing 
updates to the Improvement Activities Inventory, formalizing the 
process for adding new improvement activities to the Improvement 
Activities Inventory, and finalizing the criteria for nominating new 
improvement activities. These are discussed in detail below.
(a) Annual Call for Activities Process for Adding New Activities
(i) Transition Year
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77190), for the transition year of MIPS, we implemented the initial 
Improvement Activities Inventory and took several steps to ensure it 
was inclusive of activities in line with statutory and program 
requirements. Prior to selecting the improvement activities, we 
conducted background research. We interviewed high performing 
organizations of all sizes, conducted an environmental scan to identify 
existing models, activities, or measures that met all or part of the 
improvement activities performance category requirements, including the 
patient-centered medical homes, the Transforming Clinical Practice 
Initiative (TCPI), CAHPS surveys, and AHRQ's Patient Safety 
Organizations (81 FR 77190). In addition, we reviewed comments from the 
CY 2016 PFS final rule with comment period (80 FR 70886), and those 
received in response to the MIPS and APMs RFI published in the October 
1, 2015 Federal Register (80 FR 59102, 59106 through 59107) regarding 
the improvement activities performance category. The Improvement 
Activities Inventory finalized in the CY 2017 Quality Payment Program 
final rule (81 FR 77817 through 77831) in Table H of the Appendix, for 
the transition year and future years, was compiled as a result of the 
stakeholder input, an environmental scan, the MIPS and APMs RFI 
comments, and subsequent working sessions with AHRQ and ONC and 
additional communications with CDC, SAMHSA, and HRSA.
(ii) Year 2
    For the Quality Payment Program Year 2, we provided an informal 
process for submitting new improvement activities for potential 
inclusion in the comprehensive Improvement Activities Inventory for the 
Quality Payment Program Year 2 and future years through subregulatory 
guidance (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-MIPS_Overview-Factsheet.pdf). As part of this informal 
process, we solicited and received input from various MIPS eligible 
clinicians and organizations suggesting possible new activities via a 
nomination form that was posted on the CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/CallForMeasures.html. These nominations were 
vetted by an internal CMS review panel that conferred with other 
federal partners. New activities or modifications to existing 
activities were proposed in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30479 through 30500) Improvement Activities 
Inventory in Tables F and G of the Appendix for Year 2 of the MIPS 
program. We refer readers to the CY 2017 Quality Payment Program final 
rule (81 FR 77817 through 77831) in

[[Page 53657]]

Table H of the Appendix, for the transition year and future years and 
Tables F and G of the Appendix of this final rule with comment period 
for our finalized Improvement Activities Inventory for Year 2 and 
future years of MIPS.
(iii) Year 3 and Future Years
    For the Quality Payment Program Year 3 and future years, in the CY 
2018 Quality Payment Program proposed rule (82 FR 30055), we proposed 
to formalize an Annual Call for Activities process for adding possible 
new activities or providing modifications to the current activities in 
the Improvement Activities Inventory. We believe this is a way to 
engage eligible clinician organizations and other relevant 
stakeholders, including beneficiaries, in the identification and 
submission of improvement activities for consideration. Specifically, 
we proposed that individual MIPS eligible clinicians or groups and 
other relevant stakeholders may recommend activities for potential 
inclusion in the Improvement Activities Inventory via a similar 
nomination form that was utilized in the Year 2 of MIPS informal Annual 
Call for Activities found on the Quality Payment Program Web site at 
www.qpp.cms.gov, as discussed above. As part of this formalized 
process, individual MIPS eligible clinicians, groups, and other 
relevant stakeholders would be able to nominate new improvement 
activities that we may consider adding to the Improvement Activities 
Inventory. Individual MIPS eligible clinicians and groups and relevant 
stakeholders would be required to provide an explanation, via the 
nomination form, of how the improvement activity meets all the relevant 
criteria proposed in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30055 through 30056) and finalized below in section 
II.C.6.e.(7)(b) of this final rule with comment period.
    We refer readers to the Improvement Activities Inventory in Tables 
F and G of the Appendix of this final rule with comment period where we 
are finalizing new activities and changes to existing activities, some 
with modification. We invited public comment on our proposal to 
formalize the Annual Call for Activities process for the Quality 
Payment Program Year 3 and future years.
    Comment: Several commenters supported the proposal to formalize an 
Annual Call for Activities process to facilitate the solicitation of 
new improvement activities. The commenters supported CMS's criteria for 
improvement activities that continue to follow the priorities of the 
National Quality Strategy. In addition, other commenters noted that the 
addition of new improvement activities creates more opportunity for 
clinicians to select a suite of activities that further a particular 
improvement goal, rather than choosing several discrete activities, 
which together may not move the practice toward transformation. Several 
commenters supported the inclusion of improvement activities that 
demonstrate the delivery of patient and family centered care.
    Response: We thank the commenters for their support.
    Comment: One commenter suggested that quality and practice 
transformation standards such as the National Committee for Quality 
Assurance (NCQA) patient-centered medical home recognition should be 
the basis for reporting and validating improvement activities.
    Response: We are considering the standards for reporting and 
validation, given that each national accrediting organization has 
different reporting requirements and utilizes different standards to 
evaluate their respective patient-centered medical home recognition 
programs. Although the AHRQ patient-centered medical home definition 
(https://pcmh.ahrq.gov/page/defining-pcmh) identified national 
accrediting organizations' patient-centered medical home models which 
align around recognized functions, their standards and activities for 
evaluation of each element may be different. Likewise, the data 
collected and maintained by each accrediting organization may be 
updated during different time frames and assess or evaluate performance 
elements using different methodologies, presenting challenges to 
standardizing validation that would need to be addressed through 
further research. We are evaluating the technical feasibility of having 
an external entity report and potentially validate improvement 
activities in the future. We refer readers to the Quality Payment 
Program Web site Resource Library at https://qpp.cms.gov/ (MIPS Data 
Validation Criteria), which provides the current expected data 
validation information.
    Comment: Some commenters also encouraged CMS to ensure that 
accepted improvement activities are aligned with measures for the other 
performance categories.
    Response: We agree that it is important to create a program in 
which the performance categories are aligned as much as possible. We 
will continue to identify those improvement activities that are also 
eligible for the advancing care information performance category in the 
Improvement Activities Inventory. We encourage stakeholders to submit 
new improvement activities and modifications to existing improvement 
activities that help to align performance categories through the Annual 
Call for Activities.
    Comment: Commenters also encouraged CMS to ensure that the process 
is transparent, urged CMS to continue to be flexible and include as 
many proposed improvement activities on the final list as possible, and 
urged CMS to create more explicit inclusion criteria, which would 
further streamline the process of hospitals identifying the broader 
activity to which the discrete activity belongs. A few commenters 
expressed concern that improvement activities that were submitted were 
not accepted and urged CMS to be more transparent in the manner in 
which they make decisions about: (1) Which improvement activities are 
included and not included in the inventory, and (2) the weighting of 
improvement activities. In addition, they urged CMS to provide 
additional rationale to submitters when their recommended improvement 
activities are not accepted and engage specialists and non-specialists 
equally to select improvement activities for inclusion in the 
Inventory.
    Response: As we have developed the Improvement Activity Inventory, 
we have strived to be flexible and have accepted as many improvement 
activities as possible that are appropriate. As we work to further 
develop the Annual Call for Activities process, we intend to be as 
transparent as feasible. In the CY 2017 Quality Payment final rule (81 
FR 77190), we discussed some guidelines by which improvement activities 
are selected based on a set of criteria. We note that the Annual Call 
for Activities that was held in Year 2 for improvement activities that 
will be applicable for the 2018 performance period, was an informal 
process. We formally proposed criteria in the CY 2018 QPP proposed rule 
(82 FR 30055 through 30056) and are finalizing them in section 
II.C.6.e.(7)(b) of this final rule with comment period. We refer 
readers to section II.C.6.e.(7)(b) of this final rule with comment 
period.
    We will take the commenters' feedback into consideration as we work 
to refine the Annual Call for Activities process for future years.
    Comment: Another commenter recommended that CMS prioritize 
additional modifications to existing improvement activities and adopt 
new

[[Page 53658]]

improvement activities on a more gradual basis.
    Response: We do not disagree that we should prioritize 
modifications to the current improvement activities over new 
improvement activities as we believe they are both valuable. We must 
balance burden with including a sufficient number and variety of 
improvement activities in the Inventory so that all MIPS eligible 
clinician and groups have relevant activities to select. However, we 
are mindful of adopting new activities gradually; the Improvement 
Activities Inventory has not grown by more than 20 percent for the 2018 
performance period.
    Comment: Several commenters supported the addition of improvement 
activities for hospitals, but recommended that CMS work with partners, 
clinicians, researchers, and other stakeholders to develop a broad set 
of activities to fill existing gaps in the program. Some commenters 
expressed concern that the Inventory is too heavily focused on primary 
care and urged us to work closely with specialty societies to solicit 
and develop additional improvement activities.
    Response: We consistently engage a variety of groups within 
different specialties via webinars and listening sessions to get 
improvement activity feedback. We do not agree that the Improvement 
Activities Inventory is primary care focused as there are many 
activities specialists may perform. As discussed in the CY 2017 Quality 
Payment Program final rule (82 FR 77190), we wanted to create a broad 
list of activities that can be used by multiple practice types to 
demonstrate improvement activities and activities that may lend 
themselves to being measured for improvement in future years. We took 
several steps to ensure the initial improvement activities inventory is 
inclusive of activities in line with the statutory language. We had 
numerous interviews with highly performing organizations of all sizes, 
conducted an environmental scan to identify existing models, 
activities, or measures that met all or part of the improvement 
activities performance category. We also encourage specialties to 
submit new improvement activities and modifications to existing 
improvement activities through the Annual Call for Activities.
    Comment: Several commenters noted that it would make more sense to 
reorganize and augment the Improvement Activities Inventory to align 
explicitly with the requirements in MIPS, and for APMs. Several 
commenters believed that improvement activities should be developed and 
added that would support a practice's capacity to analyze its own 
quality data and be prepared to share downside risk in order to 
participate in an APM. The commenters encouraged CMS to align the 
thresholds and reporting requirements across performance categories for 
any of these overlapping activities, in order to reduce burden.
    Response: Section 1848(q)(2)(B)(iii) of the Act specified 
subcategories improvement activities. However, we are working to ensure 
that improvement activities align across the performance categories and 
must balance burden with including a sufficient number and variety of 
improvement activities in the Inventory so that all MIPS eligible 
clinician and groups have relevant activities to select, and in 
particular for clinicians who do not participate in APMs as we do not 
want to the Inventory to be exclusive to any one group. We encourage 
stakeholders to submit new improvement activities and modifications to 
existing improvement activities through the Annual Call for Activities.
    Comment: One commenter encouraged CMS to specify improvement 
activities for which a participant can use application programming 
interfaces (APIs) to receive another advancing care information bonus 
point. The commenter noted that doing so would further incentivize 
clinicians to utilize the API functionality for health information 
sharing with beneficiaries as part of patient engagement and care 
coordination activities.
    Response: We will take the commenter's suggestions for specifying 
improvement activities that are eligible for a bonus in the advancing 
care information performance category into consideration in future 
rulemaking. We note that in the CY 2017 Quality Payment Program final 
rule (81 FR 77182), we finalized a policy to allow MIPS eligible 
clinicians to achieve a bonus in the advancing care information 
performance category when they use functions included in CEHRT to 
complete eligible activities from the improvement activities inventory, 
and codified at Sec.  414.1380 that we would provide a designation 
indicating which activities qualify for the advancing care information 
bonus finalized. In addition, we refer readers to section II.E.5.g. of 
this final rule with comment period for details on how improvement 
activities using CEHRT relate to the objectives and measures of the 
advancing care information and improvement activities performance 
categories. We acknowledge the commenters additional suggestions and 
note that in addition to those functions included under the CEHRT 
definition, we advised in the CY 2017 Quality Payment Program final 
rule (81 FR 77199) that we may consider including additional ONC 
certified health IT capabilities as part of activities within the 
improvement activities inventory in future years. However, we are not 
making any changes to our current approach for allowing MIPS eligible 
clinicians to achieve a bonus in the advancing care performance 
category in this final rule with comment period.
    Comment: Some commenters encouraged CMS to consider the role of 
digital technologies in improving care and including related activities 
as part of continual improvement activities for future consideration. 
Some commenters supported the inclusion of telehealth-related 
improvement activities in the Inventory and suggested that these be 
high-weighted activities. A few commenters recommended that improvement 
activities that are registry-focused be assigned a high-weight, or 
alternatively, that CMS allow eligible clinicians who participate in a 
registry and meet certain basic requirements to receive the maximum 
score in this performance category.
    Response: We acknowledge commenters' suggestions for considering 
digital technologies and telehealth in improvement activities and their 
weighting in the Improvement Activities Inventory. We note that we have 
reserved high weighting for activities that directly address areas with 
the greatest impact on beneficiary care, safety, health, and well-
being, as explained in the CY 2017 Quality Payment Program final rule 
(81 FR 77194). We are not making any changes to this approach in this 
final rule with comment period; however, we will take these commenters' 
suggestions into consideration for future rulemaking. We also encourage 
stakeholders to submit activities for consideration during our formal 
Annual Call for Activities finalized in this final rule with comment 
period, as suggestions regarding improvement activity type, and content 
will be taken into consideration as part of that process. Finally, we 
do not agree that clinicians who participate in a registry and meet 
certain basic requirements should receive the maximum improvement 
activities score at this time, as we do not have sufficient data to 
determine what basic requirements might be sufficient to merit full 
credit, or what impact such an approach would have across MIPS eligible 
clinicians and groups.
    Comment: One commenter noted that some of the proposed activities 
exclude

[[Page 53659]]

clinicians who are not physicians from participation, and advised us to 
be mindful of this going forward.
    Response: We believe that this comprehensive Improvement Activities 
Inventory includes a broad range of activities that can be used by 
multiple clinician and practice types to demonstrate improvement 
activities and activities that may lend themselves to being measured 
for improvement in future years. We will take this concern into 
consideration, however, as we craft future policy, and we encourage 
stakeholders to submit new activities or suggestions for modifications 
to existing activities for consideration during our Annual Call for 
Activities.
    Comment: One commenter urged CMS to accept input from stakeholders 
regarding the weighting of several activities already included in the 
inventory that are resource intensive and currently have a medium 
weighting, and reconsider the weighting of these activities.
    Response: We refer the commenter and readers to Tables F and G in 
the Appendices of this final rule with comment period where we received 
public input on the weighting of a number of existing improvement 
activities. We previously stated that we believe high weighting should 
be used for activities that directly address areas with the greatest 
impact on beneficiary care, safety, health, and well-being, as 
explained in the CY 2017 Quality Payment Program final rule (81 FR 
77194). While we are not making any changes to this approach in this 
final rule with comment period, we will take the commenter's 
suggestions into consideration for future rulemaking. We also encourage 
commenter to submit new improvement activities, or recommendations for 
modifications to existing activities (including weighting) to us for 
consideration during the Annual Call for Activities.
    Comment: Several commenters proposed additional concepts for 
improvement activities for the Quality Payment Program Year 2, 
including improvement activities that address participation in self-
assessment or ongoing learning activities; improving access to care; 
engaging patients and families in practice governance; using telehealth 
for patient interactions; and collaborating and data-sharing with 
Regional Health Improvement Networks. Several comments were received 
requesting various new improvement activities for inclusion in the 
Improvement Activities Inventory.
    Response: We thank the commenters for their suggestions. While the 
informal process for the nominating improvement activities for MIPS 
Year 2 is now closed, we encourage stakeholders to submit new 
improvement activities and modifications to existing improvement 
activities through the upcoming Annual Call for Activities.
    Final Action: After consideration of the public comments we 
received, we are finalizing our proposal, as proposed, to formalize the 
Annual Call for Activities process for Quality Payment Program Year 3 
and future years, as discussed in this final rule with comment period.
(b) Criteria for Nominating New Improvement Activities for the Annual 
Call for Activities
    In the CY 2017 Quality Payment final rule (81 FR 77190), we 
discussed guidelines for the selection of improvement activities. In 
the CY 2018 Quality Payment Program proposed rule (82 FR 30055 and 
30485), we formally proposed that for the Quality Payment Program Year 
3 and future years, that stakeholders would apply one or more of the 
following criteria when submitting improvement activities in response 
to the proposed formal Annual Call for Activities. We intend to also 
use these criteria in selecting improvement activities for inclusion in 
the program.
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcome;
     Importance of an activity that could lead to improvement 
in practice to reduce health care disparities;
     Aligned with patient-centered medical homes;
     Activities that may be considered for an advancing care 
information bonus;
     Representative of activities that multiple individual MIPS 
eligible clinicians or groups could perform (for example, primary care, 
specialty care);
     Feasible to implement, recognizing importance in 
minimizing burden, especially for small practices, practices in rural 
areas, or in areas designated as geographic HPSAs by HRSA;
     Evidence supports that an activity has a high probability 
of contributing to improved beneficiary health outcomes; or
     CMS is able to validate the activity.
    We also noted in our proposal that in future rulemaking, activities 
that overlap with other performance categories may be proposed to be 
included if such activities support the key goals of the program.
    We invited public comment on our proposal. The following is a 
summary of the public comments received on the ``Criteria for 
Nominating New Improvement Activities for the Annual Call for 
Activities'' proposals and our responses.
    Comment: Several commenters provided suggested additional selection 
criteria: (1) Improvement activities should focus on meaningful 
activities from the person and family's point of view, not structural 
processes that do not improve clinical care; and (2) there should be 
consideration for adding new activities that focus on identifying and 
supporting the patient's family or personal caregiver. A few commenters 
requested that CMS expand the definition of eligible activities to 
include ``actions that reduce barriers to care,'' and to include 
interpretation and transportation services explicitly.
    Response: We acknowledge commenters' suggestions for additional 
criteria, and in response to these comments, we are expanding the 
proposed criteria to also include: (1) Improvement activities that 
focus on meaningful actions from the person and family's point of view; 
and (2) improvement activities that support the patient's family or 
personal caregiver. We believe these are appropriate to add, because 
they closely align with one of our MIPS strategic goals, to use a 
patient-centered approach to program development that leads to better, 
smarter, and healthier care.
    In addition, we currently include several activities in the 
Improvement Activities Inventory that address barriers to care, such as 
IA_CC_16, Primary Care Physician and Behavioral Health Bilateral 
Electronic Exchange of Information for Shared Patients, which rewards 
primary care and behavioral health practices using the same electronic 
health record system for shared patients or for exchanging information 
bilaterally and IA_PM_18 Provide Clinical-Community Linkages, which 
rewards MIPS eligible clinicians engaging community health workers to 
provide a comprehensive link to community resources through family-
based services focusing on success in health, education, and self-
sufficiency. However, we will consider criteria that address ``actions 
that reduce barriers to care'' and those that identify interpretation 
and transportation services as we craft future policies.
    Final Action: After consideration of the public comments received, 
we are finalizing with modification, for the Quality Payment Program 
Year 3 and future years, that stakeholders should apply one or more of 
the criteria when

[[Page 53660]]

submitting improvement activities in response to the Annual Call for 
Activities. In addition to the criteria listed in the proposed rule for 
nominating new improvement activities for the Annual Call for 
Activities policy we are modifying and expanding the proposed criteria 
list to also include: (1) Improvement activities that focus on 
meaningful actions from the person and family's point of view, and (2) 
improvement activities that support the patient's family or personal 
caregiver. The finalized list of criteria for submitting improvement 
activities in response to the Annual Call for Activities is as follows:
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcome;
     Importance of an activity that could lead to improvement 
in practice to reduce health care disparities;
     Aligned with patient-centered medical homes;
     Focus on meaningful actions from the person and family's 
point of view;
     Support the patient's family or personal caregiver;
     Activities that may be considered for an advancing care 
information bonus;
     Representative of activities that multiple individual MIPS 
eligible clinicians or groups could perform (for example, primary care, 
specialty care);
     Feasible to implement, recognizing importance in 
minimizing burden, especially for small practices, practices in rural 
areas, or in areas designated as geographic HPSAs by HRSA;
     Evidence supports that an activity has a high probability 
of contributing to improved beneficiary health outcomes; or
     CMS is able to validate the activity.
(c) Submission Timeline for Nominating New Improvement Activities for 
the Annual Call for Activities
    During the informal process, we accepted nominations from February 
16 through Febuary 28, 2017. For the Quality Payment Program Year 2, we 
provided an informal process for submitting new improvement activities 
for potential inclusion in the comprehensive Improvement Activities 
Inventory for the Quality Payment Program Year 2 and future years 
through subregulatory guidance (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-MIPS_Overview-Factsheet.pdf). As part 
of this informal process, we solicited and received input from various 
MIPS eligible clinicians and organizations suggesting possible new 
activities via a nomination form that was posted on the CMS Web site at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/CallForMeasures.html.
    It is our intention that the nomination and acceptance process for 
improvement activities, to the best extent possible, parallel the 
Annual Call for Measures process that is already conducted for MIPS 
quality measures. We refer readers to the CY 2017 Quality Payment 
Program final rule (81 FR 77147 through 77153) and section II.C.6.c.(1) 
of this final rule with comment period for more information. Therefore, 
aligned with this process, in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30056), we proposed to accept submissions for 
prospective improvement activities at any time during the performance 
period for the Annual Call for Activities and create an Improvement 
Activities Under Review (IAUR) list which will be displayed on a CMS 
Web site. For example, the CY 2019 performance period spans January 1, 
2019 through December 31, 2019, therefore, the submission period for CY 
2019 prospective improvement activities would be March 2, 2017 through 
March 1, 2018. When submissions are received after the March 1 deadline 
then that submission will be included in the next performance period 
activities cycle. We will consider the IAUR list we make decisions on 
which improvement activities to include in a future Improvement 
Activities Inventory. We will analyze the IAUR list while considering 
the criteria for inclusion of improvement activities as finalized in 
section II.C.6.e.(7)(b) of this final rule with comment period.
    In addition, in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30056), we proposed that for the formal Annual Call for 
Activities, only activities submitted by March 1 would be considered 
for inclusion in the Improvement Activities Inventory for the 
performance periods occurring in the following calendar year. In other 
words, we will accept improvement activities at any time throughout the 
year, however, we will only consider those improvement activities that 
are received by the March 1 deadline for the following performance 
period. This proposal was slightly different than the Call for Measures 
timeline. The Annual Call for Measures requires a 2-year implementation 
timeline, because the measures being considered for inclusion in MIPS 
undergo the pre-rulemaking process with review by the Measures 
Application Partnership (MAP) (81 FR 77153). In order to decrease the 
timeframe for activity implementation, we did not propose that 
improvement activities also undergo MAP review. Our intention is that 
while we we will accept improvement activities at any time throughout 
the year, we will close the Annual Call for Activities submissions by 
March 1 before the applicable performance period, which would enable us 
to propose the new improvement activities for adoption in the same 
year's rulemaking cycle for implementation in the following year. When 
submissions are received after the March 1 deadline then that 
submission will be included in the next performance period activities 
cycle. For example, an improvement activity submitted to the IAUR prior 
to March 1, 2018 could be considered for performance periods beginning 
in 2019. If an improvement activity submission is submitted April 1, 
2018 then the submission could be considered for performance periods 
beginning in 2020.
    In addition, in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30056), we proposed that we would add new improvement activities 
to the inventory through notice-and-comment rulemaking.
    We invited public comment on our proposals.
    Final Action: We did not receive any public comments on these 
proposals. Therefore, we are finalizing our proposals, as proposed, to: 
(1) Accept submissions for prospective improvement activities at any 
time during the performance period for the Annual Call for Activities 
and create an Improvement Activities under Review (IAUR) list; (2) only 
consider prospective activities submitted by March 1 for inclusion in 
the Improvement Activities Inventory for the performance periods 
occurring in the following calendar year; and (3) add new improvement 
activities to the inventory through notice-and-comment rulemaking.
(8) Removal of Improvement Activities
    In future years, we anticipate developing a process and 
establishing criteria for identifying activities for removal from the 
Improvement Activities Inventory through the Annual Call for Activities 
process. We anticipate proposing these requirements in the future 
through notice-and-comment rulemaking. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30056), we invited public comments on what 
criteria should be

[[Page 53661]]

used to identify improvement activities for removal from the 
Improvement Activities Inventory.
    We received a few comments on this topic and will take them into 
consideration for future rulemaking.
(9) Approach for Adding New Subcategories
    In the CY 2017 Quality Payment Program final rule (81 FR 77197), we 
finalized the following criteria for adding a new subcategory to the 
improvement activities performance category:
     The new subcategory represents an area that could 
highlight improved beneficiary health outcomes, patient engagement and 
safety based on evidence.
     The new subcategory has a designated number of activities 
that meet the criteria for an improvement activity and cannot be 
classified under the existing subcategories.
     Newly identified subcategories would contribute to 
improvement in patient care practices or improvement in performance on 
quality measures and cost performance categories.
    In the CY 2018 Quality Payment Program proposed rule at (82 FR 
30056), while we did not propose any changes to the approach for adding 
new subcategories for the improvement activities performance category, 
we did propose that in future years of the Quality Payment Program, we 
would add new improvement activities subcategories through notice-and-
comment rulemaking. We did not receive any comments on this proposal 
and are finalizing, as proposed, that in future years of the Quality 
Payment Program, we will add new improvement activities subcategories 
through notice-and-comment rulemaking.
    In the CY 2018 Quality Payment Program proposed rule at (82 FR 
30056), we also sought comments on new improvement activities 
subcategories for future consideration. In particular, in the CY 2017 
Quality Payment Program final rule (81 FR 77194), several stakeholders 
have suggested that a separate subcategory for improvement activities 
specifically related to health IT would make it easier for MIPS 
eligible clinicians and vendors to understand and earn points toward 
their final score through the use of health IT. Such a health IT 
subcategory could include only improvement activities that are 
specifically related to the advancing care information performance 
category measures and allow MIPS eligible clinicians to earn credit in 
the improvement activities performance category, while receiving a 
bonus in the advancing care information performance category as well. 
In the CY 2018 Quality Payment Program proposed rule (82 FR 30056), we 
sought suggestions on how a health IT subcategory within the 
improvement activities performance category could be structured to 
provide MIPS eligible clinicians with flexible opportunities to gain 
experience in using CEHRT and other health IT to improve their 
practice.
    We received many comments on this topic and will take these into 
consideration for future rulemaking.
(10) CMS Study on Burdens Associated With Reporting Quality Measures
(a) Background
    In the CY 2017 Quality Payment Program final rule (81 FR 77195), we 
finalized specifics regarding the CMS Study on Improvement Activities 
and Measurement including the study purpose, study participation credit 
and requirements, and the study procedure. In the CY 2018 Quality 
Payment Program proposed rule (82 FR 30056), we proposed to modify the 
name of the study to the ``CMS Study on Burdens Associated with 
Reporting Quality Measures'' to more accurately reflect the purpose of 
the study. The study assesses clinician burden and data submission 
errors associated with the collection and submission of clinician 
quality measures for MIPS, enrolling groups of different sizes and 
individuals in both rural and non-rural settings and also different 
specialties. We previously finalized that study participants receive 
full credit in the improvement activities performance category if they 
successfully elect, participate, and submit data to CMS for the full 
calendar year (81 FR 77196). In the CY 2017 final rule (81 FR 77195 
through 77197), we requested comments on the study and received 
generally supportive feedback for the study.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30056 
through 30057), we did not propose any changes to the study purpose. 
However, we proposed changes to the study participation credit and 
requirements for sample size, how the study sample is categorized into 
groups, and the study procedures for the frequency of surveys, focus 
groups, and quality data submission. These proposals are discussed in 
more detail below.
(b) Sample Size
    In addition to performing descriptive statistics to compare the 
trends in errors and burden between study years 2017 and 2018 as 
previously finalized in the (81 FR 77196), we would like to perform a 
more rigorous statistical analysis with the 2018 data, which will 
require a larger sample size. Therefore, in the CY 2018 Quality Payment 
Program proposed rule (82 FR 30056), we proposed increasing the sample 
size for CY 2018 and beyond to provide the minimum sample needed to get 
a significant result with adequate power; that is, we proposed 
increasing the number of the study participants to provide the minimum 
needed to make a meaningful and factual conclusion out of the study. 
This is described in more detail below. The sample size, as finalized 
in the CY 2017 Quality Payment Program final rule (81 FR 77196), for 
performance periods occurring in CY 2017 consisted of 42 MIPS groups as 
stated by MIPS criteria from the following seven categories:
     10 urban individual or groups of <3 eligible clinicians.
     10 rural individual or groups of <3 eligible clinicians.
     10 groups of 3-8 eligible clinicians.
     5 groups of 8-20 eligible clinicians.
     3 groups of 20-100 eligible clinicians.
     2 groups of 100 or greater eligible clinicians.
     2 specialty groups.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30057), 
we proposed to increase the sample size for the performance periods 
occurring in CY 2018 to a minimum of:
     20 urban individual or groups of <3 eligible clinicians,--
(broken down into 10 individuals and 10 groups).
     20 rural individual or groups of <3 eligible clinicians--
(broken down into 10 individuals and 10 groups).
     10 groups of 3-8 eligible clinicians.
     10 groups of 8-20 eligible clinicians.
     10 groups of 20-100 eligible clinicians.
     10 groups of 100 or greater eligible clinicians.
     6 groups of >20 eligible clinicians reporting as 
individuals--(broken down into 3 urban and 3 rural).
     6 specialty groups--(broken down into 3 reporting 
individually and 3 reporting as a group).
     Up to 10 non-MIPS eligible clinicians reporting as a group 
or individual (any number of individuals and any group size).
(c) Study Procedures
(i) Frequency of Survey and Focus Group
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30057), 
we also proposed changes to the study procedures. In the CY 2017 
Quality

[[Page 53662]]

Payment Program final rule (81 FR 77196), we finalized that for 
transition year of MIPS, study participants were required to attend a 
monthly focus group to share lessons learned in submitting quality data 
along with providing survey feedback to monitor effectiveness. However, 
an individual MIPS eligible clinician or group who chooses to report 
all 6 measures within a period of 90 days may not need to be a part of 
all of the focus groups and survey sessions after their first focus 
group and survey following the measurement data submission (81 FR 
77196). This is because they may have nothing new to contribute in 
terms of discussion of errors or clinician burdens (81 FR 77196). This 
also applied to MIPS eligible clinicians that submitted only three MIPS 
measures within the performance period, if all three measures within 
the 90-day period or at one submission (81 FR 77196). We finalized that 
all study participants would participate in surveys and focus group 
meetings at least once after each measures data submission (81 FR 
77196). For those who elect to report data for a 90-day period, we made 
further engagement optional (81 FR 77196).
    In order to prevent or reduce study participants from incurring any 
more significant additional administrative work as compared to other 
MIPS eligible clinicians not participating in the study, in the CY 2018 
Quality Payment Program proposed rule (82 FR 30057), we proposed that 
for Quality Payment Program Year 2 and future years, that study 
participants would be required to attend as frequently as four monthly 
surveys and focus group sessions throughout the year, but certain study 
participants would be able to attend less frequently. In other words, 
study participants would be required to attend a maximum of four 
surveys and focus group sessions throughout the year.
(ii) Data Submission
    We previously required study measurement data to be collected at 
baseline and then at every 3 months (quarterly basis) afterwards for 
the duration of the calendar year (81 FR 77196). We also finalized a 
minimum requirement of three MIPS quality measures, four times within 
the year (81 FR 77196). We stated that we believe this is inconsistent 
with clinicians reporting a full year's data, as we believe some study 
participants may choose to submit data for all measures at one time, or 
alternatively, may choose to submit data up to six times during the 1-
year period (82 FR 30057).
    As a result, in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30057), we proposed, for the Quality Payment Program Year 2 and 
future years, to offer study participants flexibility in their 
submissions such that they could submit all their quality measures data 
at once, as allowed in the MIPS program, and participate in study 
surveys and focus groups, while still earning improvement activities 
credit.
    We invited public comments on our proposals.
    Comment: A few commenters supported the proposal to examine the 
challenges and costs of reporting quality measures by expanding, and 
aptly renaming the ``CMS Study on Burdens Associated with Reporting 
Quality Measures.''
    Response: We thank the commenters for their support.
    Comment: A few commenters encouraged CMS to automate the process to 
reduce administrative burden and publicly share the survey results.
    Response: We note the suggestion to automate the process (that is, 
the measure data submission process) to reduce administrative burden, 
and will take this into consideration as we craft future policies. We 
also note that the current study survey and focus group have open ended 
questions that ask study participants about their recommendations and 
opinions on the ease and complexities of technology on the process. 
Furthermore, we intend to make the results of the study public 
immediately after the end of the study year CY 2018 (summer 2019) to 
all study participants, relevant stakeholders, and on the CMS Web site.
    Comment: A few commenters suggested that CMS consider additional 
study inclusion factors, such as: Practices and clinicians located in 
both urban and rural HPSAs and clinicians who serve a high proportion 
of low-income patients and patients of color.
    Response: The study selection criteria already includes; but is not 
limited to, rural, urban and geographical location (based on 
demographic characteristics) (81 FR 77195). For study years CY 2017 and 
CY 2018, we are able to analyze and compare clinicians who serve at 
both rural and urban HPSAs, based on participant's zip codes collected 
during recruitment. Additionally, we will consider for future 
rulemaking further efforts to include proportionate HPSAs and minority 
patients in the recruitment and screening of the study participants.
    Final Action: After consideration of the public comments we 
received, we are finalizing our proposals for the CY 2018 and beyond as 
proposed, to: (1) Modify the name of the study to the ``CMS Study on 
Burdens Associated with Reporting Quality Measures;'' (2) increase the 
sample size for CY 2018 and beyond as discussed previously in this 
final rule with comment period; (3) require study participants to 
attend as frequently as four monthly surveys and focus group sessions 
throughout the year; and (4) for the Quality Payment Program Year 2 and 
future years, offer study participants flexibility in their submissions 
such that they can submit all their quality measures data at once and 
participate in study surveys and focus groups while still earning 
improvement activities credit.
    It must be noted that although the aforementioned activities 
constitute an information collection request as defined in the 
implementing regulations of the Paperwork Reduction Act (PRA) of 1995 
(5 CFR 1320), the associated burden is exempt from application of the 
Paperwork Reduction Act. Specifically, section 1848(s)(7) of the Act, 
as added by section 102 of the MACRA (Pub. L. 114-10) states that 
Chapter 35 of title 44, United States Code, shall not apply to the 
collection of information for the development of quality measures. Our 
goals for new measures are to develop new high quality, low cost 
measures that are meaningful, easily understandable and operable, that 
also, reliably and validly measure what they purport. This study shall 
inform us on the root causes of clinicians' performance measure data 
collection and data submission burdens and challenges that hinders 
accurate and timely quality measurement activities. In addition, this 
study will inform us on the characteristic attributes that our new 
measures must possess to be able to accurately capture and measure the 
priorities and gaps MACRA aims for, as described in the Quality 
Measures Development Plan.\2\ This study, therefore, serves as the 
initial stage of developing new measures and also adapting existing 
measures. We believe that understanding clinician's challenges and 
skepticisms, and especially, understanding the factors that undermine 
the optimal functioning and effectiveness of quality measures are 
requisites of developing measures that are not only measuring what it 
purports but also that are user friendly and understandable for 
frontline clinicians--our main stakeholders in measure development. 
This will lead to the creation of practice-derived, tested measures 
that reduces burden and create a culture of continuous improvement in 
measure development.

[[Page 53663]]

f. Advancing Care Information Performance Category
(1) Background
    Section 1848(q)(2)(A) of the Act includes the meaningful use of 
CEHRT as a performance category under the MIPS. We refer to this 
performance category as the advancing care information performance 
category, and it is reported by MIPS eligible clinicians as part of the 
overall MIPS program. As required by sections 1848(q)(2) and (5) of the 
Act, the four performance categories of the MIPS shall be used in 
determining the MIPS final score for each MIPS eligible clinician. In 
general, MIPS eligible clinicians will be evaluated under all four of 
the MIPS performance categories, including the advancing care 
information performance category.
(2) Scoring
    Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of 
the MIPS final score shall be based on performance for the advancing 
care information performance category. We established at Sec.  
414.1380(b)(4) that the score for the advancing care information 
performance category would be comprised of a base score, performance 
score, and potential bonus points for reporting on certain measures and 
activities. For further explanation of our scoring policies for the 
advancing care information performance category, we refer readers to 81 
FR 77216-77227.
(a) Base Score
    For the CY 2018 performance period, we did not propose any changes 
to the base score methodology as established in the CY 2017 Quality 
Payment Program final rule (81 FR 77217-77223).
(b) Performance Score
    In the CY 2017 Quality Payment Program final rule (81 FR 77223 
through 77226), we finalized that MIPS eligible clinicians can earn 10 
percentage points in the performance score for meeting the Immunization 
Registry Reporting Measure. We proposed to modify our policy for 
scoring the Public Health and Clinical Data Registry Reporting 
Objective beginning with the performance period in CY 2018 because we 
have learned that there are areas of the country where immunization 
registries are not available, and we did not intend to disadvantage 
MIPS eligible clinicians practicing in those areas. We proposed if a 
MIPS eligible clinician fulfills the Immunization Registry Reporting 
Measure, the MIPS eligible clinician would earn 10 percentage points in 
the performance score. If a MIPS eligible clinician cannot fulfill the 
Immunization Registry Reporting Measure, we proposed that the MIPS 
eligible clinician could earn 5 percentage points in the performance 
score for each public health agency or clinical data registry to which 
the clinician reports for the following measures, up to a maximum of 10 
percentage points: Syndromic Surveillance Reporting; Electronic Case 
Reporting; Public Health Registry Reporting; and Clinical Data Registry 
Reporting. A MIPS eligible clinician who chooses to report to more than 
one public health agency or clinical data registry may receive credit 
in the performance score for the submission to more than one agency or 
registry; however, the MIPS eligible clinician would not earn more than 
a total of 10 percentage points for such reporting.
    We further proposed similar flexibility for MIPS eligible 
clinicians who choose to report the measures specified for the Public 
Health Reporting Objective of the 2018 Advancing Care Information 
Transition Objective and Measure set. (In section II.C.6.f.(6)(b) of 
the proposed rule, we proposed to allow MIPS eligible clinicians to 
report using the 2018 Advancing Care Information Transition Objectives 
and Measures in 2018.) We proposed if a MIPS eligible clinician 
fulfills the Immunization Registry Reporting Measure, the MIPS eligible 
clinician would earn 10 percentage points in the performance score. If 
a MIPS eligible clinician cannot fulfill the Immunization Registry 
Reporting Measure, we proposed that the MIPS eligible clinician could 
earn 5 percentage points in the performance score for each public 
health agency or specialized registry to which the clinician reports 
for the following measures, up to a maximum of 10 percentage points: 
Syndromic Surveillance Reporting; Specialized Registry Reporting. A 
MIPS eligible clinician who chooses to report to more than one 
specialized registry or public health agency to submit syndromic 
surveillance data may earn 5 percentage points in the performance score 
for reporting to each one, up to a maximum of 10 percentage points.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters supported the flexibility that we proposed to 
complete the objective and earn points in the performance score. Other 
commenters stated that they appreciate the options for earning a 
performance score. Most commenters appreciated our intent not to 
disadvantage those clinicians without access to immunization 
registries; however, they stated our proposal to award 5 percentage 
points for reporting to each additional public health agency or 
clinical data registry minimized the value of reporting to other types 
of public health information beyond immunization information. 
Commenters suggested that we award 10 percentage points in the 
performance score for reporting to a single agency or registry.
    Response: We appreciate the suggestion and did not intend to 
disadvantage MIPS eligible clinicians who lack access to immunization 
registries or do not administer immunizations. The Public Health and 
Clinical Data Registry Reporting Objective focuses on the importance of 
the ongoing lines of communication that should exist between MIPS 
eligible clinicians and public health agencies and clinical data 
registries, and we want to encourage reporting to them. These 
registries play an important part in monitoring the health status of 
patients and some, for example syndromic surveillance registries, help 
in the early detection of outbreaks, which is critical to public health 
overall. For these reasons, we are finalizing our proposal with 
modification so that a MIPS eligible clinician may earn 10 percentage 
points in the performance score for reporting to any single public 
health agency or clinical data registry, regardless of whether an 
immunization registry is available to the clinician.
    Comment: One commenter requested that we clarify that the exclusion 
for Immunization Registry Reporting is still available to those who do 
not routinely provide vaccinations.
    Response: No exclusion is available for the Immunization Registry 
Reporting Measure for the advancing care information performance 
category. The Immunization Registry Reporting Measure is part of the 
performance score in which clinicians can select which measures they 
wish to report. If they do not provide vaccinations, then they would 
not report on the Immunization Registry Reporting Measure. The final 
policy we are adopting should provide flexibility for clinicians who do 
not administer immunizations by allowing them to earn performance score 
points for public health reporting that is not related to 
immunizations.
    Final Action: After consideration of the public comments and for 
the reasons noted above, we are finalizing our proposal with 
modification. Rather than awarding 5 percentage points in the 
performance score for each public health agency or clinical data 
registry that a MIPS eligible clinician reports to (for a maximum of 10 
percentage

[[Page 53664]]

points), we are finalizing that a MIPS eligible clinician may earn 10 
percentage points in the performance score for reporting to any single 
public health agency or clinical data registry to meet any of the 
measures associated with the Public Health and Clinical Data Registry 
Reporting Objective (or any of the measures associated with the Public 
Health Reporting Objective of the 2018 Advancing Care Information 
Transition Objectives and Measures, for clinicians who choose to report 
on those measures), regardless of whether an immunization registry is 
available to the clinician. A MIPS eligible clinician can earn only 10 
percentage points in the performance score under this policy, no matter 
how many agencies or registries they report to. This policy will apply 
beginning with the 2018 performance period.
(c) Bonus Score
    In the CY 2017 Quality Payment Program final rule (81 FR 77220 
through 77226), for the Public Health and Clinical Data Registry 
Reporting Objective and the Public Health Reporting Objective, we 
finalized that MIPS eligible clinicians who report to one or more 
public health agencies or clinical data registries beyond the 
Immunization Registry Reporting Measure will earn a bonus score of 5 
percentage points in the advancing care information performance 
category. Based on our proposals discussed above to allow MIPS eligible 
clinicians who cannot fulfill the Immunization Registry Reporting 
Measure to earn additional points in the performance score, we proposed 
to modify this policy so that MIPS eligible clinicians cannot earn 
points in both the performance score and bonus score for reporting to 
the same public health agency or clinical data registry. We proposed to 
modify our policy beginning with the performance period in CY 2018. We 
proposed that a MIPS eligible clinician may earn the bonus score of 5 
percentage points for reporting to at least one additional public 
health agency or clinical data registry that is different from the 
agency/agencies or registry/or registries to which the MIPS eligible 
clinician reports to earn a performance score. A MIPS eligible 
clinician would not receive credit under both the performance score and 
bonus score for reporting to the same agency or registry.
    We proposed that for the Advancing Care Information Objectives and 
Measures, a bonus of 5 percentage points would be awarded if the MIPS 
eligible clinician reports ``yes'' for any one of the following 
measures associated with the Public Health and Clinical Data Registry 
Reporting Objective: Syndromic Surveillance Reporting; Electronic Case 
Reporting; Public Health Registry Reporting; or Clinical Data Registry 
Reporting. We proposed that for the 2018 Advancing Care Information 
Transition Objectives and Measures, a bonus of 5 percent would be 
awarded if the MIPS eligible clinician reports ``yes'' for any one of 
the following measures associated with the Public Health Reporting 
Objective: Syndromic Surveillance Reporting or Specialized Registry 
Reporting. We proposed that to earn the bonus score, the MIPS eligible 
clinician must be in active engagement with one or more additional 
public health agencies or clinical data registries that is/are 
different from the agency or registry that they identified to earn a 
performance score.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters supported the awarding of bonus points for 
reporting to an additional agency or registry. A commenter supported 
providing bonus points for registry reporting rather than mandating 
registry reporting.
    Response: We appreciate the support for our proposal.
    Comment: One commenter requested that we make it explicitly clear 
that MIPS eligible clinicians cannot earn a bonus score for reporting 
to the same agency or registry that they identified for the purposes of 
earning a performance score.
    Response: Under our final policy discussed above, MIPS eligible 
clinicians may report to a single public health or clinical data 
registry and earn 10 percentage points in the performance score. 
Reporting to a different public health or clinical data registry may 
earn the MIPS eligible clinician five percentage points in the bonus 
score. In order to earn the bonus score, the MIPS eligible clinician 
must be in active engagement with a different public health agency or 
clinical data registry than the one to which they reported to earn the 
10 percentage points for the performance score. We expect to engage in 
education and outreach efforts to ensure MIPS eligible clinicians are 
aware of the policies adopted in this final rule with comment period 
including the policy for earning bonus points for the advancing care 
information performance category.
    Comment: One commenter supported closing the loophole so that a 
MIPS eligible clinician cannot receive double credit under both the 
performance score and bonus score for reporting to the same agency or 
registry.
    Response: We appreciate the support for our proposal. As we 
proposed, MIPS eligible clinician cannot receive credit under both the 
performance score and bonus score for reporting to the same public 
health agency or registry.
    Final Action: After consideration of the public comments that we 
received, we are adopting our proposal as proposed and updating the 
regulation text at Sec.  414.1380(b)(4)(C)(1).
(d) Improvement Activities Bonus Score under the Advancing Care 
Information Performance Category
    In the CY 2017 Quality Payment Program final rule (81 FR 77202), we 
discussed our approach to the measurement of the use of health IT to 
allow MIPS eligible clinicians and groups the flexibility to implement 
health IT in a way that supports their clinical needs. Toward that end, 
we adopted a policy to award a bonus score to MIPS eligible clinicians 
who use CEHRT to complete certain activities in the improvement 
activities performance category based on our belief that the use of 
CEHRT in carrying out these activities could further the outcomes of 
clinical practice improvement.
    We adopted a final policy to award a 10 percent bonus for the 
advancing care information performance category if a MIPS eligible 
clinician attests to completing at least one of the improvement 
activities we have specified using CEHRT (81 FR 77209). We referred 
readers to Table 8 in the CY 2017 Quality Payment Program final rule 
(81 FR 77202-77209) for a list of the improvement activities eligible 
for the advancing care information performance category bonus. We 
proposed to expand this policy beginning with the CY 2018 performance 
period by identifying additional improvement activities in Table 6 (82 
FR 30060-30063) that would be eligible for the advancing care 
information performance category bonus score if they are completed 
using CEHRT functionality.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: One commenter supported rewarding clinicians who used 
CEHRT to perform improvement activities. Other commenters appreciated 
the proposed additions to the list of improvement activities using 
CEHRT that would be eligible for the bonus.
    Response: We appreciate the support as we continue to believe that 
offering this bonus will encourage MIPS eligible clinicians to use 
CEHRT not only to

[[Page 53665]]

document patient care, but also to improve their clinical practices by 
using CEHRT in a meaningful manner that supports clinical practice 
improvement. We refer readers to Table 6 which lists all improvement 
activities eligible for the advancing care information performance 
category improvement activity bonus in 2018.
    Comment: One commenter recommended that MIPS eligible clinicians 
and groups that attest to completing one or more of the improvement 
activities using CEHRT should not only earn improvement activity credit 
but also automatically earn the base score for the advancing care 
information performance category, amounting to 50 percent of the 
advancing care information performance category.
    Response: We appreciate the commenter's input and continue to be 
interested in options for incentivizing clinicians to use CEHRT in the 
completion of improvement activities. We will take this comment under 
consideration for future rulemaking on this topic.
    Final Action: After consideration of the public comments, we are 
finalizing with modifications the list of improvement activities shown 
in Table 6 that will be eligible for the advancing care information 
performance category bonus score beginning with the 2018 performance 
period if they are completed using CEHRT. We refer readers to Table F: 
New Improvement Activities for the Quality Payment Program Year 2 and 
Future Years and Table G: Improvement Activities with Changes for the 
Quality Payment Program Year 2 and Future Years for more information on 
modifications to the Improvement Activities that were proposed.

Table 6--Improvement Activities Eligible for the Advancing Care Information Performance Category Bonus Beginning
                                        With the 2018 Performance Period
----------------------------------------------------------------------------------------------------------------
                                                                               Improvement
     Improvement activity                                                       activity       Related advancing
     performance category         Activity name           Activity             performance      care information
          subcategory                                                        category weight      measure(s) *
----------------------------------------------------------------------------------------------------------------
Expanded Practice Access......  Provide 24/7       Provide 24/7 access to  Medium............  Provide Patient
                                 access to          MIPS eligible                               Access.
                                 eligible           clinicians, groups,                        Secure Messaging.
                                 clinicians or      or care teams for                          Send A Summary of
                                 groups who have    advice about urgent                         Care.
                                 real-time access   and emergent care                          Request/Accept
                                 to patient's       (for example, MIPS                          Summary of Care.
                                 medical record.    eligible clinician
                                                    and care team access
                                                    to CEHRT, cross-
                                                    coverage with access
                                                    to CEHRT, or protocol-
                                                    driven nurse line
                                                    with access to CEHRT)
                                                    that could include
                                                    one or more of the
                                                    following:
                                                    Expanded
                                                    hours in evenings and
                                                    weekends with access
                                                    to the patient
                                                    medical record (for
                                                    example, coordinate
                                                    with small practices
                                                    to provide alternate
                                                    hour office visits
                                                    and urgent care);
                                                    Use of
                                                    alternatives to
                                                    increase access to
                                                    care team by MIPS
                                                    eligible clinicians
                                                    and groups, such as e-
                                                    visits, phone visits,
                                                    group visits, home
                                                    visits and alternate
                                                    locations (for
                                                    example, senior
                                                    centers and assisted
                                                    living centers); and/
                                                    or
                                                    Provision of
                                                    same-day or next-day
                                                    access to a
                                                    consistent MIPS
                                                    eligible clinician,
                                                    group or care team
                                                    when needed for
                                                    urgent care or
                                                    transition
                                                    management.
Patient Safety and Practice     Communication of   A MIPS eligible         Medium............  Secure Messaging.
 Assessment.                     Unscheduled        clinician providing                        Send A Summary of
                                 Visit for          unscheduled care                            Care.
                                 Adverse Drug       (such as an emergency                      Request/Accept
                                 Event and Nature   room, urgent care, or                       Summary of Care.
                                 of Event.          other unplanned
                                                    encounter) attests
                                                    that, for greater
                                                    than 75 percent of
                                                    case visits that
                                                    result from a
                                                    clinically
                                                    significant adverse
                                                    drug event, the MIPS
                                                    eligible clinician
                                                    transmits
                                                    information,
                                                    including through the
                                                    use of CEHRT to the
                                                    patient's primary
                                                    care clinician
                                                    regarding both the
                                                    unscheduled visit and
                                                    the nature of the
                                                    adverse drug event
                                                    within 48 hours. A
                                                    clinically
                                                    significant adverse
                                                    event is defined as a
                                                    medication-related
                                                    harm or injury such
                                                    as side-effects,
                                                    supratherapeutic
                                                    effects, allergic
                                                    reactions, laboratory
                                                    abnormalities, or
                                                    medication errors
                                                    requiring urgent/
                                                    emergent evaluation,
                                                    treatment, or
                                                    hospitalization.
Patient Safety and Practice     Consulting AUC     Clinicians attest that  High..............  Clinical Decision
 Assessment.                     using clinical     they are consulting                         Support (CEHRT
                                 decision support   specified applicable                        function only).
                                 when ordering      AUC through a
                                 advanced           qualified clinical
                                 diagnostic         decision support
                                 imaging.           mechanism for all
                                                    applicable imaging
                                                    services furnished in
                                                    an applicable
                                                    setting, paid for
                                                    under an applicable
                                                    payment system, and
                                                    ordered on or after
                                                    January 1, 2018. This
                                                    activity is for
                                                    clinicians that are
                                                    early adopters of the
                                                    Medicare AUC program
                                                    (2018 performance
                                                    year) and for
                                                    clinicians that begin
                                                    the Medicare AUC
                                                    program in future
                                                    years as specified in
                                                    our regulation at
                                                    Sec.   414.94. The
                                                    AUC program is
                                                    required under
                                                    section 218 of the
                                                    Protecting Access to
                                                    Medicare Act of 2014.
                                                    Qualified mechanisms
                                                    will be able to
                                                    provide a report to
                                                    the ordering
                                                    clinician that can be
                                                    used to assess
                                                    patterns of image-
                                                    ordering and improve
                                                    upon those patterns
                                                    to ensure that
                                                    patients are
                                                    receiving the most
                                                    appropriate imaging
                                                    for their individual
                                                    condition.
Patient Safety and Practice     Cost Display for   Implementation of a     Medium............  Clinical Decision
 Assessment.                     Laboratory and     cost display for                            Support (CEHRT
                                 Radiographic       laboratory and                              function only).
                                 Orders.            radiographic orders,
                                                    such as costs that
                                                    can be obtained
                                                    through the Medicare
                                                    clinical laboratory
                                                    fee schedule.

[[Page 53666]]

 
Population Management.........  Glycemic           For at-risk outpatient  Medium............  Patient-Specific
                                 Screening          Medicare                                    Education.
                                 Services.          beneficiaries,                             Patient Generated
                                                    individual MIPS                             Health Data or
                                                    eligible clinicians                         Data from Non-
                                                    and groups must                             clinical
                                                    attest to                                   Settings.
                                                    implementation of
                                                    systematic preventive
                                                    approaches in
                                                    clinical practice for
                                                    at least 60 percent
                                                    for the 2018
                                                    performance period
                                                    and 75 percent in
                                                    future years, of
                                                    CEHRT with
                                                    documentation of
                                                    screening patients
                                                    for abnormal blood
                                                    glucose according to
                                                    current U.S.
                                                    Preventive Services
                                                    Task Force (USPSTF)
                                                    and/or American
                                                    Diabetes Association
                                                    (ADA) guidelines.
Population Management.........  Glycemic           For outpatient          High..............  Patient Generated
                                 management         Medicare                                    Health Data.
                                 services.          beneficiaries with                         Clinical
                                                    diabetes and who are                        Information
                                                    prescribed                                  Reconciliation.
                                                    antidiabetic agents                        Clinical Decision
                                                    (for example,                               Support, CCDS,
                                                    insulin,                                    Family Health
                                                    sulfonylureas), MIPS                        History (CEHRT
                                                    eligible clinicians                         functions only).
                                                    and groups must
                                                    attest to having:
                                                   For the first
                                                    performance period,
                                                    at least 60 percent
                                                    of medical records
                                                    with documentation of
                                                    an individualized
                                                    glycemic treatment
                                                    goal that:
                                                   [cir] Takes into
                                                    account patient-
                                                    specific factors,
                                                    including, at least
                                                    (1) age, (2)
                                                    comorbidities, and
                                                    (3) risk for
                                                    hypoglycemia, and.
                                                   [cir] Is reassessed at
                                                    least annually.
                                                   The performance
                                                    threshold will
                                                    increase to 75
                                                    percent for the
                                                    second performance
                                                    period and onward.
                                                   Clinicians would
                                                    attest that, 60
                                                    percent for first
                                                    year, or 75 percent
                                                    for the second year,
                                                    of their medical
                                                    records that document
                                                    individualized
                                                    glycemic treatment
                                                    represent patients
                                                    who are being treated
                                                    for at least 90 days
                                                    during the
                                                    performance period.
Population Management.........  Glycemic           For at-risk outpatient  Medium............  Patient-Specific
                                 Referring          Medicare                                    Education.
                                 Services.          beneficiaries,                             Patient Generated
                                                    individual MIPS                             Health Data or
                                                    eligible clinicians                         Data from Non-
                                                    and groups must                             clinical
                                                    attest to                                   Settings.
                                                    implementation of
                                                    systematic preventive
                                                    approaches in
                                                    clinical practice for
                                                    at least 60 percent
                                                    for the CY 2018
                                                    performance period
                                                    and 75 percent in
                                                    future years, of
                                                    CEHRT with
                                                    documentation of
                                                    referring eligible
                                                    patients with
                                                    prediabetes to a CDC-
                                                    recognized diabetes
                                                    prevention program
                                                    operating under the
                                                    framework of the
                                                    National Diabetes
                                                    Prevention Program.
Population Management.........  Anticoagulant      Individual MIPS         High..............  Provide Patient
                                 management         eligible clinicians                         Access.
                                 improvements.      and groups who                             Patient-Specific
                                                    prescribe oral                              Education.
                                                    Vitamin K antagonist                       View, Download,
                                                    therapy (warfarin)                          Transmit.
                                                    must attest that, for                      Secure Messaging.
                                                    60 percent of                              Patient Generated
                                                    practice patients in                        Health Data or
                                                    the transition year                         Data from Non-
                                                    and 75 percent of                           Clinical
                                                    practice patients in                        Setting.
                                                    Quality Payment                            Send a Summary of
                                                    Program Year 2 and                          Care.
                                                    future years, their                        Request/Accept
                                                    ambulatory care                             Summary of Care.
                                                    patients receiving                         Clinical
                                                    warfarin are being                          Information
                                                    managed by one or                           Reconciliation
                                                    more of the following                       Exchange.
                                                    improvement                                Clinical Decision
                                                    activities;.                                Support (CEHRT
                                                    Patients are                        Function Only).
                                                    being managed by an
                                                    anticoagulant
                                                    management service,
                                                    that involves
                                                    systematic and
                                                    coordinated care,
                                                    incorporating
                                                    comprehensive patient
                                                    education, systematic
                                                    prothrombin time (PT-
                                                    INR) testing,
                                                    tracking, follow-up,
                                                    and patient
                                                    communication of
                                                    results and dosing
                                                    decisions;.
                                                    Patients are
                                                    being managed
                                                    according to
                                                    validated electronic
                                                    decision support and
                                                    clinical management
                                                    tools that involve
                                                    systematic and
                                                    coordinated care,
                                                    incorporating
                                                    comprehensive patient
                                                    education, systematic
                                                    PT-INR testing,
                                                    tracking, follow-up,
                                                    and patient
                                                    communication of
                                                    results and dosing
                                                    decisions;.
                                                    For rural or
                                                    remote patients,
                                                    patients are managed
                                                    using remote
                                                    monitoring or
                                                    telehealth options
                                                    that involve
                                                    systematic and
                                                    coordinated care,
                                                    incorporating
                                                    comprehensive patient
                                                    education, systematic
                                                    PT-INR testing,
                                                    tracking, follow-up,
                                                    and patient
                                                    communication of
                                                    results and dosing
                                                    decisions; and/or
                                                    For patients
                                                    who demonstrate
                                                    motivation,
                                                    competency, and
                                                    adherence, patients
                                                    are managed using
                                                    either a patient self-
                                                    testing (PST) or
                                                    patient-self-
                                                    management (PSM)
                                                    program.

[[Page 53667]]

 
Population Management.........  Provide Clinical-  Engaging community      Medium............  Provide Patient
                                 Community          health workers to                           Access.
                                 Linkages.          provide a                                  Patient-Specific
                                                    comprehensive link to                       Education.
                                                    community resources                        Patient-Generated
                                                    through family-based                        Health Data.
                                                    services focusing on
                                                    success in health,
                                                    education, and self-
                                                    sufficiency. This
                                                    activity supports
                                                    individual MIPS
                                                    eligible clinicians
                                                    or groups that
                                                    coordinate with
                                                    primary care and
                                                    other clinicians,
                                                    engage and support
                                                    patients, use of
                                                    CEHRT, and employ
                                                    quality measurement
                                                    and improvement
                                                    processes. An example
                                                    of this community
                                                    based program is the
                                                    NCQA Patient-Centered
                                                    Connected Care (PCCC)
                                                    Recognition Program
                                                    or other such
                                                    programs that meet
                                                    these criteria.
Population Management.........  Advance Care       Implementation of       Medium............  Patient-Specific
                                 Planning.          practices/processes                         Education.
                                                    to develop advance                         Patient-Generated
                                                    care planning that                          Health Data.
                                                    includes: Documenting
                                                    the advance care plan
                                                    or living will within
                                                    CEHRT, educating
                                                    clinicians about
                                                    advance care planning
                                                    motivating them to
                                                    address advance care
                                                    planning needs of
                                                    their patients, and
                                                    how these needs can
                                                    translate into
                                                    quality improvement,
                                                    educating clinicians
                                                    on approaches and
                                                    barriers to talking
                                                    to patients about end-
                                                    of-life and
                                                    palliative care needs
                                                    and ways to manage
                                                    its documentation, as
                                                    well as informing
                                                    clinicians of the
                                                    healthcare policy
                                                    side of advance care
                                                    planning.
Population Management.........  Chronic care and   Proactively manage      Medium............  Provide Patient
                                 preventative       chronic and                                 Access.
                                 care management    preventive care for                        Patient-Specific
                                 for empanelled     empanelled patients                         Education.
                                 patients.          that could include                         View, Download,
                                                    one or more of the                          Transmit.
                                                    following:                                 Secure Messaging.
                                                    Provide                            Patient Generated
                                                    patients annually                           Health Data or
                                                    with an opportunity                         Data from Non-
                                                    for development and/                        Clinical
                                                    or adjustment of an                         Setting.
                                                    individualized plan                        Send A Summary of
                                                    of care as                                  Care.
                                                    appropriate to age                         Request/Accept
                                                    and health status,                          Summary of Care.
                                                    including health risk                      Clinical
                                                    appraisal; gender,                          Information
                                                    age and condition-                          Reconciliation.
                                                    specific preventive                        Clinical Decision
                                                    care services; plan                         Support, Family
                                                    of care for chronic                         Health History
                                                    conditions; and                             (CEHRT functions
                                                    advance care                                only).
                                                    planning;.
                                                    Use condition-
                                                    specific pathways for
                                                    care of chronic
                                                    conditions (for
                                                    example,
                                                    hypertension,
                                                    diabetes, depression,
                                                    asthma and heart
                                                    failure) with
                                                    evidence-based
                                                    protocols to guide
                                                    treatment to target;.
                                                    Use pre-visit
                                                    planning to optimize
                                                    preventive care and
                                                    team management of
                                                    patients with chronic
                                                    conditions;.
                                                    Use panel
                                                    support tools
                                                    (registry
                                                    functionality) to
                                                    identify services
                                                    due;.
                                                    Use reminders
                                                    and outreach (for
                                                    example, phone calls,
                                                    emails, postcards,
                                                    patient portals and
                                                    community health
                                                    workers where
                                                    available) to alert
                                                    and educate patients
                                                    about services due;
                                                    and/or
                                                    Routine
                                                    medication
                                                    reconciliation
Population Management.........  Implementation of  Provide longitudinal    Medium............  Provide Patient
                                 methodologies      care management to                          Access.
                                 for improvements   patients at high risk                      Patient-Specific
                                 in longitudinal    for adverse health                          Education.
                                 care management    outcome or harm that                       Patient Generated
                                 for high risk      could include one or                        Health Data or
                                 patients.          more of the                                 Data from Non-
                                                    following:                                  clinical
                                                    Use a                               Settings.
                                                    consistent method to                       Send A Summary of
                                                    assign and adjust                           Care.
                                                    global risk status                         Request/Accept
                                                    for all empaneled                           Summary of Care.
                                                    patients to allow                          Clinical
                                                    risk stratification                         information
                                                    into actionable risk                        reconciliation.
                                                    cohorts. Monitor the                       Clinical Decision
                                                    risk-stratification                         Support, CCDS,
                                                    method and refine as                        Family Health
                                                    necessary to improve                        History, Patient
                                                    accuracy of risk                            List (CEHRT
                                                    status                                      functions only).
                                                    identification;.
                                                    Use a
                                                    personalized plan of
                                                    care for patients at
                                                    high risk for adverse
                                                    health outcome or
                                                    harm, integrating
                                                    patient goals, values
                                                    and priorities; and/
                                                    or.
                                                    Use on-site
                                                    practice-based or
                                                    shared care managers
                                                    to proactively
                                                    monitor and
                                                    coordinate care for
                                                    the highest risk
                                                    cohort of patients..
Population Management.........  Implementation of  Provide episodic care   Medium............  Send A Summary of
                                 episodic care      management, including                       Care.
                                 management         management across                          Request/Accept
                                 practice.          transitions and                             Summary of Care.
                                                    referrals that could                       Clinical
                                                    include one or more                         Information
                                                    of the following:                           Reconciliation.
                                                    Routine and
                                                    timely follow-up to
                                                    hospitalizations, ED
                                                    visits and stays in
                                                    other institutional
                                                    settings, including
                                                    symptom and disease
                                                    management, and
                                                    medication
                                                    reconciliation and
                                                    management; and/or.
                                                    Managing care
                                                    intensively through
                                                    new diagnoses,
                                                    injuries and
                                                    exacerbations of
                                                    illness..

[[Page 53668]]

 
Population Management.........  Implementation of  Manage medications to   Medium............  Clinical
                                 medication         maximize efficiency,                        Information
                                 management         effectiveness and                           Reconciliation.
                                 practice           safety that could                          Clinical Decision
                                 improvements.      include one or more                         Support,
                                                    of the following:                           Computerized
                                                    Reconcile and                       Physician Order
                                                    coordinate                                  Entry Electronic
                                                    medications and                             Prescribing
                                                    provide medication                          (CEHRT functions
                                                    management across                           only).
                                                    transitions of care
                                                    settings and eligible
                                                    clinicians or groups;.
                                                    Integrate a
                                                    pharmacist into the
                                                    care team; and/or.
                                                    Conduct
                                                    periodic, structured
                                                    medication reviews..
Achieving Health Equity.......  Promote use of     Demonstrate             High..............  Public Health
                                 patient-reported   performance of                              Registry
                                 outcome tools.     activities for                              Reporting.
                                                    employing patient-                         Clinical Data
                                                    reported outcome                            Registry
                                                    (PRO) tools and                             Reporting.
                                                    corresponding                              Patient-Generated
                                                    collection of PRO                           Health Data.
                                                    data (e.g., use of
                                                    PQH-2 or PHQ-9 and
                                                    PROMIS instruments)
                                                    such as patient
                                                    reported Wound
                                                    Quality of Life
                                                    (QoL), patient
                                                    reported Wound
                                                    Outcome, and patient
                                                    reported Nutritional
                                                    Screening.
Care Coordination.............  Practice           Develop pathways to     Medium............  Send a Summary of
                                 Improvements       neighborhood/                               Care.
                                 that Engage        community-based                            Request/Accept
                                 Community          resources to support                        Summary of Care.
                                 Resources to       patient health goals                       Patient-Generated
                                 Support Patient    that could include                          Health Data.
                                 Health Goals.      one or more of the
                                                    following:
                                                    Maintain
                                                    formal (referral)
                                                    links to community-
                                                    based chronic disease
                                                    self-management
                                                    support programs,
                                                    exercise programs and
                                                    other wellness
                                                    resources with the
                                                    potential for
                                                    bidirectional flow of
                                                    information and
                                                    provide a guide to
                                                    available community
                                                    resources..
                                                    Including
                                                    through the use of
                                                    tools that facilitate
                                                    electronic
                                                    communication between
                                                    settings;.
                                                    Screen
                                                    patients for health-
                                                    harming legal needs;
                                                    Screen and
                                                    assess patients for
                                                    social needs using
                                                    tools that are CEHRT
                                                    enabled and that
                                                    include to any extent
                                                    standards-based,
                                                    coded question/field
                                                    for the capture of
                                                    data as is feasible
                                                    and available as part
                                                    of such tool; and/or
                                .................   Provide a
                                                    guide to available
                                                    community resources.
Care Coordination.............  Primary Care       The primary care and    Medium............  Send a Summary of
                                 Physician and      behavioral health                           Care.
                                 Behavioral         practices use the                          Request/Accept
                                 Health Bilateral   same CEHRT system for                       Summary of Care.
                                 Electronic         shared patients or
                                 Exchange of        have an established
                                 Information for    bidirectional flow of
                                 Shared Patients.   primary care and
                                                    behavioral health
                                                    records.
Care Coordination.............  PSH Care           Participation in a      Medium............  Send a Summary of
                                 Coordination.      Perioperative                               Care.
                                                    Surgical Home (PSH)                        Request/Accept
                                                    that provides a                             Summary of Care.
                                                    patient-centered,                          Clinical
                                                    physician-led,                              Information
                                                    interdisciplinary,                          Reconciliation.
                                                    and team-based system                      Health
                                                    of coordinated                              Information
                                                    patient care, which                         Exchange.
                                                    coordinates care from
                                                    pre-procedure
                                                    assessment through
                                                    the acute care
                                                    episode, recovery,
                                                    and post-acute care.
                                                    This activity allows
                                                    for reporting of
                                                    strategies and
                                                    processes related to
                                                    care coordination of
                                                    patients receiving
                                                    surgical or
                                                    procedural care
                                                    within a PSH. The
                                                    clinician must
                                                    perform one or more
                                                    of the following care
                                                    coordination
                                                    activities:
                                                    Coordinate
                                                    with care managers/
                                                    navigators in
                                                    preoperative clinic
                                                    to plan and
                                                    implementation
                                                    comprehensive post
                                                    discharge plan of
                                                    care;
                                                    Deploy
                                                    perioperative clinic
                                                    and care processes to
                                                    reduce post-operative
                                                    visits to emergency
                                                    rooms;.
                                                    Implement
                                                    evidence-informed
                                                    practices and
                                                    standardize care
                                                    across the entire
                                                    spectrum of surgical
                                                    patients; or.
                                                    Implement
                                                    processes to ensure
                                                    effective
                                                    communications and
                                                    education of
                                                    patients' post-
                                                    discharge
                                                    instructions.
Care Coordination.............  Implementation of  Performance of regular  Medium............  Send A Summary of
                                 use of             practices that                              Care.
                                 specialist         include providing                          Request/Accept
                                 reports back to    specialist reports                          Summary of Care.
                                 referring          back to the referring                      Clinical
                                 clinician or       MIPS eligible                               Information
                                 group to close     clinician or group to                       Reconciliation.
                                 referral loop.     close the referral
                                                    loop or where the
                                                    referring MIPS
                                                    eligible clinician or
                                                    group initiates
                                                    regular inquiries to
                                                    specialist for
                                                    specialist reports
                                                    which could be
                                                    documented or noted
                                                    in the CEHRT.
Care Coordination.............  Implementation of  Implementation of       Medium............  Secure Messaging.
                                 documentation      practices/processes,                       Send A Summary of
                                 improvements for   including a                                 Care.
                                 developing         discussion on care,                        Request/Accept
                                 regular            to develop regularly                        Summary of Care.
                                 individual care    updated individual                         Clinical
                                 plans.             care plans for at-                          Information
                                                    risk patients that                          Reconciliation.
                                                    are shared with the
                                                    beneficiary or
                                                    caregiver(s).
                                                    Individual care plans
                                                    should include
                                                    consideration of a
                                                    patient's goals and
                                                    priorities, as well
                                                    as desired outcomes
                                                    of care.

[[Page 53669]]

 
Care Coordination.............  Implementation of  Implementation of       Medium............  Provide Patient
                                 practices/         practices/processes                         Access (formerly
                                 processes for      to develop regularly                        Patient Access).
                                 developing         updated individual                         View, Download,
                                 regular            care plans for at-                          Transmit.
                                 individual care    risk patients that                         Secure Messaging.
                                 plans.             are shared with the                        Patient Generated
                                                    beneficiary or                              Health Data or
                                                    caregiver(s).                               Data from Non-
                                                                                                Clinical
                                                                                                Setting.
Care Coordination.............  Practice           Ensure that there is    Medium............  Send A Summary of
                                 improvements for   bilateral exchange of                       Care.
                                 bilateral          necessary patient                          Request/Accept
                                 exchange of        information to guide                        Summary of Care.
                                 patient            patient care, such as                      Clinical
                                 information.       Open Notes, that                            Information
                                                    could include one or                        Reconciliation.
                                                    more of the
                                                    following:
                                                    Participate
                                                    in a Health
                                                    Information Exchange
                                                    if available; and/or.
                                                    Use
                                                    structured referral
                                                    notes.
Beneficiary Engagement........  Engage Patients    Engage patients and     High..............  Patient-Generated
                                 and Families to    families to guide                           Health Data.
                                 Guide              improvement in the                         Provide Patient
                                 Improvement in     system of care by                           Access.
                                 the System of      leveraging digital                         View, Download,
                                 Care.              tools for ongoing                           or Transmit.
                                                    guidance and
                                                    assessments outside
                                                    the encounter,
                                                    including the
                                                    collection and use of
                                                    patient data for
                                                    return-to-work and
                                                    patient quality of
                                                    life improvement.
                                                    Platforms and devices
                                                    that collect patient-
                                                    generated health data
                                                    (PGHD) must do so
                                                    with an active
                                                    feedback loop, either
                                                    providing PGHD in
                                                    real or near-real
                                                    time to the care
                                                    team, or generating
                                                    clinically endorsed
                                                    real or near-real
                                                    time automated
                                                    feedback to the
                                                    patient. Includes
                                                    patient reported
                                                    outcomes (PROs).
                                                    Examples include
                                                    patient engagement
                                                    and outcomes tracking
                                                    platforms, cellular
                                                    or web-enabled bi-
                                                    directional systems,
                                                    and other devices
                                                    that transmit
                                                    clinically valid
                                                    objective and
                                                    subjective data back
                                                    to care teams.
                                                   Because many consumer-
                                                    grade devices capture
                                                    PGHD (for example,
                                                    wellness devices),
                                                    platforms or devices
                                                    eligible for this
                                                    improvement activity
                                                    must be, at a
                                                    minimum, endorsed and
                                                    offered clinically by
                                                    care teams to
                                                    patients to
                                                    automatically send
                                                    ongoing guidance (one
                                                    way). Platforms and
                                                    devices that
                                                    additionally collect
                                                    PGHD must do so with
                                                    an active feedback
                                                    loop, either
                                                    providing PGHD in
                                                    real or near-real
                                                    time to the care
                                                    team, or generating
                                                    clinically endorsed
                                                    real or near-real
                                                    time automated
                                                    feedback to the
                                                    patient (e.g.
                                                    automated patient-
                                                    facing instructions
                                                    based on glucometer
                                                    readings). Therefore,
                                                    unlike passive
                                                    platforms or devices
                                                    that may collect but
                                                    do not transmit PGHD
                                                    in real or near-real
                                                    time to clinical care
                                                    teams, active devices
                                                    and platforms can
                                                    inform the patient or
                                                    the clinical care
                                                    team in a timely
                                                    manner of important
                                                    parameters regarding
                                                    a patient's status,
                                                    adherence,
                                                    comprehension, and
                                                    indicators of
                                                    clinical concern.
Beneficiary Engagement........  Use of CEHRT to    In support of           Medium............  Provide Patient
                                 capture patient    improving patient                           Access.
                                 reported           access, performing                         Patient-Specific
                                 outcomes.          additional activities                       Education.
                                                    that enable capture                        Care Coordination
                                                    of patient reported                         through Patient
                                                    outcomes (for                               Engagement.
                                                    example, home blood
                                                    pressure, blood
                                                    glucose logs, food
                                                    diaries, at-risk
                                                    health factors such
                                                    as tobacco or alcohol
                                                    use, etc.) or patient
                                                    activation measures
                                                    through use of CEHRT,
                                                    containing this data
                                                    in a separate queue
                                                    for clinician
                                                    recognition and
                                                    review.
Beneficiary Engagement........  Engagement of      Access to an enhanced   Medium............  Provide Patient
                                 patients through   patient portal that                         Access.
                                 implementation.    provides up to date                        Patient-Specific
                                                    information related                         Education.
                                                    to relevant chronic
                                                    disease health or
                                                    blood pressure
                                                    control, and includes
                                                    interactive features
                                                    allowing patients to
                                                    enter health
                                                    information and/or
                                                    enables bidirectional
                                                    communication about
                                                    medication changes
                                                    and adherence.
Beneficiary Engagement........  Engagement of      Engage patients,        Medium............  Provide Patient
                                 patients, family   family and caregivers                       Access.
                                 and caregivers     in developing a plan                       Patient-specific
                                 in developing a    of care and                                 Education.
                                 plan of care.      prioritizing their                         View, Download,
                                                    goals for action,                           Transmit
                                                    documented in the                           (Patient
                                                    CEHRT.                                      Action).
                                                                                               Secure Messaging.
Patient Safety and Practice...  Use of decision    Use decision support    Medium............  Clinical Decision
                                 support and        and protocols to                            Support (CEHRT
                                 standardized       manage workflow in                          function only).
                                 treatment          the team to meet
                                 protocols.         patient needs.

[[Page 53670]]

 
Achieving Health Equity.......  Promote Use of     Demonstrate             Medium............  Patient Generated
                                 Patient-Reported   performance of                              Health Data or
                                 Outcome Tools.     activities for                              Data from a Non-
                                                    employing patient-                          Clinical
                                                    reported outcome                            Setting.
                                                    (PRO) tools and                            Public Health and
                                                    corresponding                               Clinical Data
                                                    collection of PRO                           Registry
                                                    data such as the use                        Reporting.
                                                    of PQH-2 or PHQ-9,
                                                    PROMIS instruments,
                                                    patient reported
                                                    Wound Quality of Life
                                                    (QoL), patient
                                                    reported Wound
                                                    Outcome, and patient
                                                    reported Nutritional
                                                    Screening.
Behavioral and Mental Health..  Implementation of  Offer integrated        High..............  Provide Patient
                                 integrated         behavioral health                           Access.
                                 Patient Centered   services to support                        Patient-Specific
                                 Behavioral         patients with                               Education.
                                 Health (PCBH)      behavioral health                          View, Download,
                                 model.             needs, dementia, and                        Transmit.
                                                    poorly controlled                          Secure Messaging.
                                                    chronic conditions.                        Patient Generated
                                                    The services could                          Health Data or
                                                    include one or more                         Data from Non-
                                                    of the following:.                          Clinical
                                                    Use evidence-                       Setting.
                                                    based treatment                            Care coordination
                                                    protocols and                               through Patient
                                                    treatment to goal                           Engagement.
                                                    where appropriate;.                        Send A Summary of
                                                    Use evidence-                       Care.
                                                    based screening and
                                                    case finding
                                                    strategies to
                                                    identify individuals
                                                    at risk and in need
                                                    of services;.
                                                    Ensure
                                                    regular communication
                                                    and coordinated
                                                    workflows between
                                                    eligible clinicians
                                                    in primary care and
                                                    behavioral health;.
                                                    Conduct
                                                    regular case reviews
                                                    for at-risk or
                                                    unstable patients and
                                                    those who are not
                                                    responding to
                                                    treatment;.
                                                    Use of a
                                                    registry or certified
                                                    health information
                                                    technology
                                                    functionality to
                                                    support active care
                                                    management and
                                                    outreach to patients
                                                    in treatment; and/or
                                                    Integrate                          Request/Accept
                                                    behavioral health and                       Summary of Care.
                                                    medical care plans
                                                    and facilitate
                                                    integration through
                                                    co-location of
                                                    services when
                                                    feasible; and/or
                                                    Participate
                                                    in the National
                                                    Partnership to
                                                    Improve Dementia Care
                                                    Initiative, which
                                                    promotes a
                                                    multidimensional
                                                    approach that
                                                    includes public
                                                    reporting, state-
                                                    based coalitions,
                                                    research, training,
                                                    and revised surveyor
                                                    guidance.
Behavioral and Mental Health..  Electronic Health  Enhancements to CEHRT   Medium............  Patient Generated
                                 Record             to capture additional                       Health Data or
                                 Enhancements for   data on behavioral                          Data from Non-
                                 BH data capture.   health (BH)                                 Clinical
                                                    populations and use                         Setting.
                                                    that data for                              Send A Summary of
                                                    additional decision-                        Care.
                                                    making purposes (for                       Request/Accept
                                                    example, capture of                         Summary of Care.
                                                    additional BH data                         Clinical
                                                    results in additional                       Information
                                                    depression screening                        Reconciliation.
                                                    for at-risk patient
                                                    not previously
                                                    identified).
----------------------------------------------------------------------------------------------------------------

(3) Performance Periods for the Advancing Care Information Performance 
Category
    In the CY 2017 Quality Payment Program final rule (81 FR 77210 
through 77211), we established a performance period for the advancing 
care information performance category to align with the overall MIPS 
performance period of one full year to ensure all four performance 
categories are measured and scored based on the same period of time. We 
stated for the first and second performance periods of MIPS (CYs 2017 
and 2018), we will accept a minimum of 90 consecutive days of data and 
encourage MIPS eligible clinicians to report data for the full year 
performance period. We proposed the same policy for the advancing care 
information performance category for the performance period in CY 2019, 
Quality Payment Program Year 3, and would accept a minimum of 90 
consecutive days of data in CY 2019.
    Comment: Commenters supported the continuation of a performance 
period of a minimum of 90 consecutive days of data in CY 2019. Some 
stated that maintaining the 90-day performance period for the first 3 
years of MIPS is important to add stability for the reporting on the 
performance category. One commenter requested that we maintain the 90-
day performance period for the advancing care information performance 
category in perpetuity as a shorter period enables physicians to adopt 
innovative uses of technology and permits flexibility to test new 
health IT solutions.
    Response: While we believe a 90-day performance period is 
appropriate for advancing care information for the 2017, 2018 and 2019 
performance periods, we believe it is premature to establish the 
performance periods for any additional years at this time. We will 
consider creating a 90-day performance period for 2020 and beyond and 
may address this issue in future rulemaking.
    Comment: A few commenters expressed their disappointment that we 
proposed another 90-day performance period for 2019 and urged us to 
move to full calendar year reporting as soon as possible. They stated 
that patients and families should be able to experience the benefits of 
health IT--getting questions answered through secure email, or having 
summary of care records incorporated into new providers' health records 
-any day of the year, rather than a particular three-month period.
    Response: Although we proposed that the MIPS performance period for 
the advancing care information performance category would be a minimum 
of 90 consecutive days, MIPS eligible clinicians have the option to 
submit data for longer periods up to a full calendar year. Furthermore, 
we believe

[[Page 53671]]

that once the functionality in the 2015 Edition CEHRT is implemented, 
MIPS eligible clinicians will use it all the time.
    Final Action: After consideration of the public comments, we are 
adopting our policy as proposed. We will accept a minimum of 90 
consecutive days of data in CY 2019 and are revising Sec.  
414.1320(d)(1).
(4) Certification Requirements
    In the CY 2017 Quality Payment Program final rule (81 FR 77211 
through 77213), we outlined the requirements for MIPS eligible 
clinicians using CEHRT during the CY 2017 performance period for the 
advancing care information performance category as it relates to the 
objectives and measures they select to report, and also outlined 
requirements for the CY 2018 performance period. We additionally 
adopted a definition of CEHRT at Sec.  414.1305 for MIPS eligible 
clinicians that is based on the definition that applies in the EHR 
Incentive Programs under Sec.  495.4.
    For the CY 2017 performance period, we adopted a policy by which 
MIPS eligible clinicians may use EHR technology certified to either the 
2014 or 2015 Edition certification criteria, or a combination of the 
two. For the CY 2018 performance period, we previously stated that MIPS 
eligible clinicians must use EHR technology certified to the 2015 
Edition to meet the objectives and measures specified for the advancing 
care information performance category. We received significant comments 
from the CY 2017 Quality Payment Program final rule and feedback from 
stakeholders through meetings and listening sessions requesting that we 
extend the use of 2014 Edition CEHRT beyond CY 2017 into CY 2018. Many 
commenters expressed concern over the lack of products certified to the 
2015 Edition. Other commenters stated that switching from the 2014 
Edition to the 2015 Edition requires a large amount of time and 
planning and if it is rushed there is a potential risk to patient 
health. Also, our experience with the transition from EHR technology 
certified to the 2011 Edition to EHR technology certified to the 2014 
Edition did make us aware of the many issues associated with the 
adoption of EHR technology certified to a new Edition. These include 
the time that will be necessary to effectively deploy EHR technology 
certified to the 2015 Edition standards and certification criteria and 
to make the necessary patient safety, staff training, and workflow 
investments to be prepared to report for the advancing care information 
performance category for 2018. Thus, we proposed that MIPS eligible 
clinicians may use EHR technology certified to either the 2014 or 2015 
Edition certification criteria, or a combination of the two for the CY 
2018 performance period. We proposed to amend Sec.  414.1305 to reflect 
this change.
    We further noted, that to encourage new participants to adopt 
certified health IT and to incentivize participants to upgrade their 
technology to 2015 Edition products which better support 
interoperability across the care continuum, we proposed to offer a 
bonus of 10 percentage points under the advancing care information 
performance category for MIPS eligible clinicians who report the 
Advancing Care Information Objectives and Measures for the performance 
period in CY 2018 using only 2015 Edition CEHRT. We proposed to amend 
Sec.  414.1380(b)(4)C)(3) to reflect this change. We proposed this one-
time bonus for CY 2018 to support and recognize MIPS eligible 
clinicians and groups that invest in implementing certified EHR 
technology in their practice. We sought comment on the proposed bonus, 
the proposed amount of percentage points for the bonus, and whether the 
bonus should be limited to new participants in MIPS and small 
practices.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Most commenters supported our proposal to allow the use of 
2014 Edition or 2015 Edition CEHRT or a combination for the 2018 
performance period. One stated that allowing flexibility allows 
clinicians more time to fully evaluate their EHR optimization in a 
meaningful way that ensures EHR systems are in place, tested thoroughly 
and operating as intended. Many stated that an additional transition 
year would be very helpful in allowing physicians to plan for the 
required upgrades, which can be costly and time-consuming. A few 
commenters supported our proposal because they believed it would delay 
the requirement to report on the Advancing Care Information Objectives 
and Measures derived from meaningful use Stage 3 in 2018.
    Response: We thank commenters for their feedback and support of 
CEHRT flexibility in 2018. We hope that allowing MIPS eligible 
clinicians to use 2014 Edition or 2015 Edition CEHRT or a combination 
of the two in 2018 will allow for a smooth transition to 2015 Edition 
CEHRT.
    Comment: One commenter requested that we affirm that 2015 Edition 
CEHRT will be required for the 2019 performance period so that they can 
plan accordingly.
    Response: Under our current policy as reflected in Sec.  414.1305, 
2015 Edition CEHRT will be required in the performance period in 2019. 
We believe that there are many benefits for MIPS eligible clinicians 
and their patients implementing the 2015 Edition of CEHRT. These 
include enabling health information exchange through new and enhanced 
certification criteria standards, as well as through implementation 
specifications for interoperability. The 2015 Edition also incorporates 
changes that are designed to spur innovation and provide more choices 
to health care providers and patients for the exchange of electronic 
health information, including new Application Programming Interface 
(API) certification criteria.
    Comment: Several commenters stated their disappointment with the 
proposed delayed transition to 2015 Edition CEHRT as they believe that 
it includes significant patient-facing technologies and new 
functionalities to support patient engagement and improve 
interoperability.
    Response: While we understand the concern, we believe that it is 
important to provide MIPS eligible clinicians with flexibility and more 
time to adopt and implement 2015 CEHRT We recognize there is burden 
associated with the development and deployment of each new version of 
CEHRT, which may be labor intensive and expensive for clinicians so we 
believe the additional time will be welcomed. In addition if MIPS 
eligible clinicians are ready to report using the 2015 Edition, we 
encourage them to do so.
    Comment: Most commenters supported our proposal to award a 10 
percentage point bonus for using 2015 Edition CEHRT exclusively in 
2018.
    Response: We appreciate the support for this proposal and believe 
the bonus will incentivize MIPS eligible clinicians to work to 
implement 2015 Edition CEHRT by 2018.
    Comment: Some commenters suggested that we offer a bonus to those 
MIPS eligible clinicians who use a combination of 2014 Edition and 2015 
Edition CEHRT in 2018. Others suggested that the bonus be available not 
only in 2018 but also in 2019. Other commenters requested that the 
bonus be available to all MIPS eligible clinicians regardless of 
whether they are new to the MIPS program or not. Other commenters 
believed that CMS has struck an appropriate balance of minimizing the 
regulatory burden on clinicians not yet prepared to transition to 2015 
Edition CEHRT, while

[[Page 53672]]

incentivizing those clinicians who have transitioned to 2015 Edition 
CEHRT.
    Response: We believe it is appropriate to award the bonus only to 
those MIPS eligible clinicians who are able to use only the 2015 
Edition of CEHRT in 2018. We understand that it is challenging to 
transition from the 2014 Edition to the 2015 Edition of CEHRT and wish 
to incentivize clinicians to complete the transition. We believe this 
bonus will help to incentivize participants to continue the process of 
upgrading from 2014 Edition to 2015 Edition, especially small practices 
where the investment in updated workflows and implementation may 
present unique challenges. We agree with commenters that the bonus 
should be available to all MIPS eligible clinicians who use 2015 
Edition CEHRT exclusively in 2018. In addition, we intend this bonus to 
support and recognize the efforts to report on the Advancing Care 
Information Measures using EHR technology certified to the 2015 
Edition, which include more robust measures using updated standards and 
functions which support interoperability.
    Comment: Several commenters requested that the bonus points 
available for using 2015 Edition CEHRT be raised from 10 percentage 
points to 20 percentage points because it would provide stronger 
incentive for clinicians to upgrade to and implement 2015 Edition CEHRT 
for use in 2018, thereby expanding the availability of 2015 Edition 
enhancements, such as the new open APIs. A few commenters recommended 
that we provide a bonus of 15 percentage points. Commenters expressed 
concern that adding only 10 percentage points to the score for the use 
of 2015 Edition CEHRT is too trivial an incentive and would do little 
to offset the work participants must do to prepare to participate in 
the Quality Payment Program.
    Response: We disagree and believe that a 10 percentage point bonus 
provides an adequate incentive for MIPS eligible clinicians to use 2015 
Edition CEHRT exclusively for a minimum of a 90-day performance period 
in 2018. Additionally, the addition of this 10 percentage point bonus 
would bring the total bonus points available under the advancing care 
information performance category to 25 percentage points. We remind 
readers that a MIPS eligible clinician may earn a maximum score of 165 
percentage points (including the 2015 Edition CEHRT bonus) for the 
advancing care information performance category, but all scores of 100 
percentage points and higher will receive full credit for the category 
(25 percentage points) in the final score.
    Comment: One commenter did not support bonus points for clinicians 
that adopt 2015 Edition CEHRT in 2018 because they do not agree that 
2015 Edition CEHRT enhances a physician's ability to provide higher 
quality care. Another commenter indicated that providing bonus points 
may disadvantage clinicians who have prior experience with CEHRT but 
are unable to fully implement the 2015 Edition due to vendor issues 
beyond their control.
    Response: While we appreciate these concerns, we believe that the 
availability of the bonus is appropriate and we wish to incentivize 
clinicians to complete the transition to 2015 Edition CEHRT in 2018.
    Final Action: After consideration of the public comments, we are 
adopting as proposed our proposal to allow the use of 2014 Edition or 
2015 Edition CEHRT, or a combination of the two Editions, for the 
performance period in 2018. We will offer a one-time bonus of 10 
percentage points under the advancing care information performance 
category for MIPS eligible clinicians who report the Advancing Care 
Information Objectives and Measures for the performance period in CY 
2018 using only 2015 Edition CEHRT. We will not limit the bonus to new 
participants. We are revising Sec. Sec.  414.1305 and 414.1380(b)(4) of 
the regulation text to reflect this policy.
(5) Scoring Methodology Considerations
    Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of 
the MIPS final score shall be based on performance for the advancing 
care information performance category. Further, section 
1848(q)(5)(E)(ii) of the Act, provides that in any year in which the 
Secretary estimates that the proportion of eligible professionals (as 
defined in section 1848(o)(5) of the Act) who are meaningful EHR users 
(as determined under section 1848(o)(2) of the Act) is 75 percent or 
greater, the Secretary may reduce the applicable percentage weight of 
the advancing care information performance category in the MIPS final 
score, but not below 15 percent, and increase the weightings of the 
other performance categories such that the total percentage points of 
the increase equals the total percentage points of the reduction. We 
noted that section 1848(o)(5) of the Act defines an eligible 
professional as a physician, as defined in section 1861(r) of the Act.
    In CY 2017 Quality Payment Program final rule (81 FR 77226-77227), 
we established a final policy, for purposes of applying section 
1848(q)(5)(E)(ii) of the Act, to estimate the proportion of physicians 
as defined in section 1861(r) of the Act who are meaningful EHR users, 
as those physician MIPS eligible clinicians who earn an advancing care 
information performance category score of at least 75 percent for a 
performance period. We established that we will base this estimation on 
data from the relevant performance period, if we have sufficient data 
available from that period. We stated that we will not include in the 
estimation physicians for whom the advancing care information 
performance category is weighted at zero percent under section 
1848(q)(5)(F) of the Act, which we relied on in the CY 2017 Quality 
Payment Program final rule (81 FR 77226 through 77227) to establish 
policies under which we would weigh the advancing care information 
performance category at zero percent of the final score. In addition, 
we proposed not to include in the estimation physicians for whom the 
advancing care information performance category would be weighted at 
zero percent under the proposal in section II.C.6.f.(7) of the proposed 
rule to implement certain provisions of the 21st Century Cures Act 
(that is, physicians who are determined hospital-based or ambulatory 
surgical center-based, or who are granted an exception based on 
significant hardship or decertified EHR technology).
    We stated that we were considering modifications to the policy we 
established in last year's rulemaking to base our estimation of 
physicians who are meaningful EHR users for a MIPS payment year (for 
example, 2019) on data from the relevant performance period (for 
example, 2017). We stated our concern that if in future rulemaking we 
decide to propose to change the weight of the advancing care 
information performance category based on our estimation, such a change 
may cause confusion to MIPS eligible clinicians who are adjusting to 
the MIPS program and believe this performance category will make up 25 
percent of the final score for the 2019 MIPS payment year. We noted the 
earliest we would be able to make our estimation based on 2017 data and 
propose in future rulemaking to change the weight of the advancing care 
information performance category for the 2019 MIPS payment year would 
be in mid-2018, as the deadline for data submission is March 31, 2018. 
We requested public comments on whether this timeframe is sufficient, 
or whether a more extended timeframe would be preferable. We proposed 
to modify our existing policy such that we would base our estimation

[[Page 53673]]

of physicians who are meaningful EHR users for a MIPS payment year on 
data from the performance period that occurs 4 years before the MIPS 
payment year.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Some commenters supported our proposal because they 
believed it was appropriate to allow additional time to ensure that 
clinicians are aware of the percentage weighting of each MIPS 
performance category. A few commenters stated that more certainty and 
advance notice will offer MIPS eligible clinicians more time to prepare 
and focus resources on areas of most significance.
    Response: We thank commenters for their support and agree that 
additional time to determine whether the advancing care information 
category weight should be reduced is necessary. Once we make a 
determination we will communicate such a change to the percentage 
weighting of each of the MIPS performance categories to MIPS eligible 
clinicians.
    Comment: Some commenters stated that the timeline that we proposed 
was not sufficient. Commenters stated that a proposal to change the 
weight would not be finalized until late in 2018 and would be applied 
to the 2019 MIPS performance period/2021 payment year which does not 
give clinicians sufficient time to be educated and respond to the 
changes in the category weights. Other commenters stated that any 
change to the MIPS program, specifically the possibility of a change in 
the weight of the advancing care information performance category, will 
have a domino effect on various aspects of the program, as well as 
within the health IT space. Based on updated category weight 
allocation, which would change the overall computation of a MIPS score, 
health IT developers will need to make adjustments to their products 
and software accordingly. In turn, those products must be implemented 
by clinicians. For product lifecycles, there needs to be at least 12 
months' notice given for all parties to adequately plan and execute 
these changes. The proposed timeline that CMS has outlined (for 
performance period 2017/payment year 2019, the earliest feedback would 
be in mid-2018 that would in turn effect the weight of performance 
period 2019/payment year 2021) would allow for notification of less 
than a year, and is therefore not sufficient.
    Response: While we understand these concerns, we previously 
finalized our policy to base our estimation of physicians who are 
meaningful EHR users for a MIPS payment year on data from the relevant 
performance period for the MIPS payment year. For example, for the 2019 
MIPS payment year, the performance period is two years prior to the 
payment year, in 2017. We proposed to extend the look-back period to 
the performance period that occurs 4 years before the MIPS payment 
year, which would give additional time for MIPS eligible clinicians and 
health IT developers to adjust to the new weighting prior to the start 
of the actual performance period for the MIPS payment year. We continue 
to believe that this timeframe is sufficient.
    Comment: Some commenters expressed concern with the proposal to 
base CMS' estimation of meaningful EHR users on data from the 
performance period that occurs 4 years before the MIPS payment year. 
According to the commenters, the 4-year look-back period is 
unreasonably long given the rapid pace of technology, especially given 
continued delays in adopting 2015 Edition technology. Commenters 
encouraged CMS to shorten this look-back period. Prematurely reducing 
the advancing care information performance category's weight could 
impair progress towards robust, person-centered uses of health IT.
    Response: While we appreciate these concerns, we also believe that 
it is important to give MIPS eligible clinicians sufficient notice 
before we change the weighting of a category so that they can plan 
appropriately. We note that the earliest data we can use to calculate 
the proportion of physicians who are meaningful EHR users will be the 
data from the 2017 performance period, which will not be available 
until 2018. Under our current policy, 2018 is the earliest we would be 
able to propose in rulemaking to reduce and redistribute the weight of 
the advancing care information performance category for the 2019 MIPS 
payment year, based on the proportion of physicians who were meaningful 
EHR users during the performance period in 2017. As previously stated, 
we believe it is important for MIPS eligible clinicians to be aware of 
this reweighting prior to the relevant performance period during which 
they would be measured for the MIPS payment year, which is why we 
believe the proposed 4-year timeline is more appropriate.
    Comment: Some commenters recommended keeping the advancing care 
information performance category as 25 percent of the MIPS final score 
in years in which 75 percent or more of physicians are meaningful EHR 
users. Other commenters recommended that if the weight of the advancing 
care information performance category is reduced, it should not all be 
redistributed to the quality category. Many commenters suggested that 
it be redistributed to quality and improvement activities performance 
categories particularly for physicians for whom there are not the 
required number of meaningful quality measures.
    Response: We appreciate this input. We intend to make our decision 
about whether to change the performance category weight based on data 
from the performance period that is 4 years prior to the MIPS payment 
year. We have not yet proposed a new weight for the advancing care 
information performance category or to which category or categories the 
points would be distributed.
    Comment: A few commenters stated that it is too early to consider 
reweighting a category before any data has been received or analyzed. 
When reweighting is implemented, they urged CMS to ensure that 
clinicians are informed of the reweighting prior to the performance 
period. Changing the weight of a performance category retrospectively 
would add confusion to an already complex program.
    Response: We have not yet proposed to reduce the weight of the 
performance category. We are simply establishing the timeframe for when 
we would decide whether to reduce and redistribute the weight.
    Comment: Several commenters suggested that any proposed changes to 
the weight of the advancing care information performance category 
resulting from an assessment of the proportion of clinicians who are 
meaningful EHR users, for example, those who achieve an advancing care 
information performance category score of at least 75 percent, should 
be based on at least two to three MIPS performance periods worth of 
data to ensure an accurate baseline.
    Response: We agree that this decision should be made with 
consideration for the reliability and validity of data, however, we 
disagree that it would require multiple performance periods to obtain 
the necessary data to make this determination. We also note that we are 
not proposing to base this decision on any particular year at this 
point in time, we are only addressing the timeframe relationship 
between when the data is reported and when the reweighting would take 
place. For example, should the data show that 75 percent or more 
physicians are considered meaningful users based on data submitted for 
the 2017 performance period, we would propose to reweight the advancing 
care information performance category weight in 2021 instead of 2019. 
We

[[Page 53674]]

believe this policy would allow adequate time for MIPS eligible 
clincians, EHR vendors and other stakeholders to adjust to the new 
scoring structure prior to submitting data for the effected payment 
year.
    Final Action: Based on the public comments and for the reasons 
discussed in the proposed rule, we are adopting our proposal as 
proposed. Our ability to implement this policy will be dependent on the 
availability of data from the performance period that occurs 4 years 
before the MIPS payment year.
(6) Objectives and Measures
(a) Advancing Care Information Objectives and Measures Specifications
    We proposed to maintain for the CY 2018 performance period the 
Advancing Care Information Objectives and Measures as finalized in the 
CY 2017 Quality Payment Program final rule (81 FR 77227 through 77229). 
We proposed the following modifications to certain objectives and 
measures.
    Provide Patient Access Measure: For at least one unique patient 
seen by the MIPS eligible clinician: (1) The patient (or the patient-
authorized representative) is provided timely access to view online, 
download, and transmit his or her health information; and (2) The MIPS 
eligible clinician ensures the patient's health information is 
available for the patient (or patient-authorized representative) to 
access using any application of their choice that is configured to meet 
the technical specifications of the Application Programing Interface 
(API) in the MIPS eligible clinician's CEHRT.
    Proposed definition of timely: Beginning with the 2018 performance 
period, we proposed to define ``timely'' as within 4 business days of 
the information being available to the MIPS eligible clinician. This 
definition of timely is the same as we adopted under the EHR Incentive 
Programs (80 FR 62815).
    Proposed change to the View, Download, Transmit (VDT) Measure: 
During the performance period, at least one unique patient (or patient-
authorized representatives) seen by the MIPS eligible clinician 
actively engages with the EHR made accessible by the MIPS eligible 
clinician by either (1) viewing, downloading or transmitting to a third 
party their health information; or (2) accessing their health 
information through the use of an API that can be used by applications 
chosen by the patient and configured to the API in the MIPS eligible 
clinician's CEHRT; or (3) a combination of (1) and (2). We proposed 
this change because we erroneously described the actions in the measure 
(viewing, downloading or transmitting; or accessing through an API) as 
being taken by the MIPS eligible clinician rather than the patient or 
the patient-authorized representatives. We proposed this change would 
apply beginning with the performance period in 2017.
    Objective: Health Information Exchange.
    Objective: The MIPS eligible clinician provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other health care clinician into their EHR using the functions of 
CEHRT.
    Proposed change to the Objective: The MIPS eligible clinician 
provides a summary of care record when transitioning or referring their 
patient to another setting of care, receives or retrieves a summary of 
care record upon the receipt of a transition or referral or upon the 
first patient encounter with a new patient, and incorporates summary of 
care information from other health care providers into their EHR using 
the functions of CEHRT.
    We inadvertently used the term ``health care clinician'' and 
proposed to replace it with the more appropriate term ``health care 
provider''. We proposed this change would apply beginning with the 
performance period in 2017.
    Send a Summary of Care Measure: For at least one transition of care 
or referral, the MIPS eligible clinician that transitions or refers 
their patient to another setting of care or health care clinician (1) 
creates a summary of care record using CEHRT; and (2) electronically 
exchanges the summary of care record.
    Proposed Change to the Send a Summary of Care Measure: For at least 
one transition of care or referral, the MIPS eligible clinician that 
transitions or refers their patient to another setting of care or 
health care provider (1) creates a summary of care record using CEHRT; 
and (2) electronically exchanges the summary of care record.
    We inadvertently used the term ``health care clinician'' and 
proposed to replace it with the more appropriate term ``health care 
provider''. We proposed this change would apply beginning with the 2017 
performance period.
    Syndromic Surveillance Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
syndromic surveillance data from a non-urgent care ambulatory setting 
where the jurisdiction accepts syndromic data from such settings and 
the standards are clearly defined.
    Proposed change to the Syndromic Surveillance Reporting Measure: 
The MIPS eligible clinician is in active engagement with a public 
health agency to submit syndromic surveillance data.
    We proposed this change because we inadvertently finalized the 
measure description that we had proposed for Stage 3 of the EHR 
Incentive Program (80 FR 62866) and not the measure description that we 
finalized (80 FR 62970). We are modifying the proposed change so that 
it does align with the measure description finalized for Stage 3 by 
adding the phrase ``from an urgent care setting'' to the end of the 
measure description.
    In the proposed rule, we noted that we have split the Specialized 
Registry Reporting Measure that we adopted under the 2017 Advancing 
Care Information Transition Objectives and Measures into two separate 
measures, Public Health Registry Reporting and Clinical Data Registry 
Reporting, to better define the registries available for reporting. We 
proposed to allow MIPS eligible clinicians and groups to continue to 
count active engagement in electronic public health reporting with 
specialized registries. We proposed to allow these registries to be 
counted for purposes of reporting the Public Health Registry Reporting 
Measure or the Clinical Data Registry Reporting Measure beginning with 
the 2018 performance period. A MIPS eligible clinician may count a 
specialized registry if the MIPS eligible clinician achieved the phase 
of active engagement as described under ``active engagement option 3: 
production'' in the 2015 EHR Incentive Programs final rule with comment 
period (80 FR 62862 through 62865), meaning the clinician has completed 
testing and validation of the electronic submission and is 
electronically submitting production data to the public health agency 
or clinical data registry.
(b) 2017 and 2018 Advancing Care Information Transition Objectives and 
Measures Specifications
    In the CY 2017 Quality Payment Program final rule (81 FR 77229 
through 77237), we finalized the 2017 Advancing Care Information 
Transition Objectives and Measures for MIPS eligible clinicians using 
EHR technology certified to the 2014 Edition. Because we proposed in 
section II.C.6.f.(4) of the

[[Page 53675]]

proposed rule to continue to allow the use of EHR technology certified 
to the 2014 Edition in the 2018 performance period, we also proposed to 
allow MIPS eligible clinicians to report the 2017 Advancing Care 
Information Transition Objectives and Measures in 2018. We proposed to 
make several modifications identified and described below to the 2017 
Advancing Care Information Transition Objectives and Measures for the 
advancing care information performance category of MIPS for the 2017 
and 2018 performance periods.
    Objective: Patient Electronic Access.
    Objective: The MIPS eligible clinician provides patients (or 
patient-authorized representative) with timely electronic access to 
their health information and patient-specific education.
    Proposed Change to the Objective.
    We proposed to modify this objective beginning with the 2017 
performance period by removing the word ``electronic'' from the 
description of timely access as it was erroneously included in the 
final rule (81 FR 77228).
    Objective: Patient-Specific Education.
    Objective: The MIPS eligible clinician provides patients (or 
patient authorized representative) with timely electronic access to 
their health information and patient-specific education.
    Proposed Change to the Objective: The MIPS eligible clinician uses 
clinically relevant information from CEHRT to identify patient-specific 
educational resources and provide those resources to the patient. We 
inadvertently finalized the description of the Patient Electronic 
Access Objective for the Patient-Specific Education Objective, so that 
the Patient-Specific Education Objective had the wrong description. We 
proposed to correct this error by adopting the description of the 
Patient-Specific Education Objective adopted under modified Stage 2 in 
the 2015 EHR Incentive Programs final rule (80 FR 62809 and 80 FR 
62815). We proposed this change would apply beginning with the 
performance period in 2017.
    Objective: Health Information Exchange.
    Objective: The MIPS eligible clinician provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other health care clinicians into their EHR using the functions of 
CEHRT.
    Proposed change to the Objective: The MIPS eligible clinician 
provides a summary of care record when transitioning or referring their 
patient to another setting of care, receives or retrieves a summary of 
care record upon the receipt of a transition or referral or upon the 
first patient encounter with a new patient, and incorporates summary of 
care information from other health care providers into their EHR using 
the functions of CEHRT.
    We inadvertently used the term ``health care clinician'' and 
proposed to replace it with the more appropriate term ``health care 
provider''. We proposed this change would apply beginning with the 
performance period in 2017.
    Health Information Exchange Measure: The MIPS eligible clinician 
that transitions or refers their patient to another setting of care or 
health care clinician (1) uses CEHRT to create a summary of care 
record; and (2) electronically transmits such summary to a receiving 
health care clinician for at least one transition of care or referral.
    Proposed change to the measure: The MIPS eligible clinician that 
transitions or refers their patient to another setting of care or 
health care provider (1) uses CEHRT to create a summary of care record; 
and (2) electronically transmits such summary to a receiving health 
care provider for at least one transition of care or referral.
    We inadvertently used the term ``health care clinician'' and 
proposed to replace it with the more appropriate term ``health care 
provider''. We proposed this change would apply beginning with the 
performance period in 2017.
    Denominator: Number of transitions of care and referrals during the 
performance period for which the EP was the transferring or referring 
health care clinician.
    Proposed change to the denominator: Number of transitions of care 
and referrals during the performance period for which the MIPS eligible 
clinician was the transferring or referring health care provider. This 
change reflects the change proposed to the Health Information Exchange 
Measure replacing ``health care clinician'' with ``health care 
provider.'' We also inadvertently referred to the EP in the description 
and are replacing ``EP'' with ``MIPS eligible clinician.'' We proposed 
this change would apply beginning with the performance period in 2017.
    Objective: Medication Reconciliation.
    Proposed Objective: We proposed to add a description of the 
Medication Reconciliation Objective beginning with the CY 2017 
performance period, which we inadvertently omitted from the CY 2017 
Quality Payment Program proposed and final rules, as follows:
    Proposed Objective: The MIPS eligible clinician who receives a 
patient from another setting of care or provider of care or believes an 
encounter is relevant performs medication reconciliation. This 
description aligns with the objective adopted for Modified Stage 2 at 
80 FR 62811.
    Medication Reconciliation Measure: The MIPS eligible clinician 
performs medication reconciliation for at least one transition of care 
in which the patient is transitioned into the care of the MIPS eligible 
clinician.
     Numerator: The number of transitions of care or referrals 
in the denominator where the following three clinical information 
reconciliations were performed: Medication list, Medication allergy 
list, and current problem list.
    Proposed Modification to the Numerator.
    Proposed Numerator: The number of transitions of care or referrals 
in the denominator where medication reconciliation was performed.
    We proposed to modify the numerator by removing medication list, 
medication allergy list, and current problem list. These three criteria 
were adopted for Stage 3 (80 FR 62862) but not for Modified Stage 2 (80 
FR 62811). We proposed this change would apply beginning with the 
performance period in 2017.
    The following is a summary of the public comments received on the 
``Advancing Care Information Objectives and Measures'' and the ``2017 
and 2018 Advancing Care Information Transition Objectives and 
Measures'' proposals and our responses:
    Comment: Several commenters were confused by our proposal related 
to specialized registries and active engagement option 3, production, 
believing that the only way to receive credit for the Public Health 
Agency and Clinical Data Registry Reporting Objective is through the 
production option.
    Response: MIPS eligible clinicians may fulfill the Public Health 
Agency and Clinical Data Registry Reporting Objective or the Public 
Health Reporting Objective through any of the active engagement options 
as described at 80 FR 62818-62819: completed registration to submit 
data; testing and validation; or production. Our proposal pertained to 
MIPS eligible clinicians who choose to use option 3, production, for 
specialized registries.
    Comment: Several commenters supported the proposed definition of 
timely for the Patient Electronic Access

[[Page 53676]]

Measure. One stated that the proposed definition supports practice 
workflows where patient information may become available prior to a 
weekend or holiday. This proposal would allow the necessary time for an 
eligible clinician to review and ensure accurate information is made 
available to patients.
    Response: We appreciate the support for our proposal. We sought to 
give MIPS eligible clinicians sufficient time to make information 
available. We specified 4 business days so as not to include holidays 
and weekends.
    Comment: In the interest of reducing administrative burden, a 
commenter encouraged the alignment of the definition of ``timely'' for 
the ``Provide Patient Access Measure'' in the Medicaid EHR Incentive 
Program and the Quality Payment Program. For both programs, they 
supported defining ``timely'' as follows: Providing access to health 
information within 4 business days of the information being available 
to the MIPS eligible clinician, as opposed to the 48 hour standard in 
Stage 3 of the Medicaid EHR Incentive Program.
    Response: We understand that there are two different definitions of 
timely. We proposed 4 business days for MIPS because we believe it 
provides an adequate timeframe for a new program and the clinicians who 
may not have previously participated in the Medicare and Medicaid EHR 
Incentive Programs. We may consider aligning the Medicaid EHR Incentive 
Program definition in the future.
    Comment: One commenter disagreed with our proposal related to the 
Patient Electronic Access Objective and suggested that the definition 
of timely access under the Health Insurance Portability and 
Accountability Act (HIPAA) is appropriate. The commenter stated that 
under the HIPAA Privacy Rule, a covered entity must act on an 
individual's request for access no later than 30 calendar days after 
receipt of the request.
    Response: We disagree and believe that 4 business days will provide 
MIPS eligible clinicians with an adequate amount of time to provide 
their patients with electronic access to their health information. We 
further note that the HIPAA timeframe relates to an individual's 
request for their information and the Patient Electronic Access Measure 
relates to information being made available regardless of whether a 
request is made.
    Comment: One commenter cautioned CMS of the unintended consequences 
related to the proposed definition of providing ``timely'' access for 
patients or their authorized representatives. The commenter stated that 
the proposed definition of timely (4 business days) may result in the 
inability of clinicians to achieve the base score, and thus, any 
advancing care information performance category score.
    Response: While we appreciate this concern, we believe that by 
establishing the definition of timely as 4 business days MIPS eligible 
clinicians should have a sufficient amount of time to fulfill the 
Patient Electronic Access Measure. We also note that you only need to 
provide timely access for one patient to achieve the base score for the 
advancing care information performance category.
    Comment: Most commenters supported the proposed modifications to 
the Advancing Care Information Objectives and Measures as reasonable 
and appropriate. Another commenter stated that until an overhaul of the 
advancing care information performance category is undertaken, they 
support the modifications as proposed and urged CMS to finalize them as 
described.
    Response: We thank commenters for their support of the proposed 
modifications and agree that these modifications should be finalized.
    Comment: Some commenters suggested that we clarify that MIPS 
eligible clinicians may report either the Advancing Care Information 
Objectives and Measures or the Advancing Care Information Transition 
Objectives and Measures using 2015 Edition or 2014 Edition CEHRT.
    Response: For the 2018 performance period, MIPS eligible clinicians 
will have the option to report the Advancing Care Information 
Transition Objectives and Measures using 2014 Edition CEHRT, 2015 
Edition CEHRT, or a combination of 2014 and 2015 Edition CEHRT, as long 
as the EHR technology they possess can support the objectives and 
measures to which they plan to attest. Similarly, MIPS eligible 
clinicians will have the option to attest to the Advancing Care 
Information Objectives and Measures using 2015 Edition CEHRT or a 
combination of 2014 and 2015 Edition CEHRT, as long as their EHR 
technology can support the objectives and measures to which they plan 
to attest.
    Final Action: After considering the public comments that we 
received, we are finalizing our proposals as proposed with one 
modification to the description of the Syndromic Surveillance Reporting 
Measure: The MIPS eligible clinician is in active engagement with a 
public health agency to submit syndromic surveillance data from an 
urgent care setting.

 Table 7--2018 Performance Period Advancing Care Information Performance Category Scoring Methodology Advancing
                                    Care Information Objectives and Measures
----------------------------------------------------------------------------------------------------------------
                                    2018 advancing       Required/not
 2018 advancing care information   care information    required for base   Performance score       Reporting
            objective                   measure           score (50%)         (up to 90%)         requirement
----------------------------------------------------------------------------------------------------------------
Protect Patient Health            Security Risk       Required..........  0.................  Yes/No Statement.
 Information.                      Analysis.
Electronic Prescribing..........  e-Prescribing **..  Required..........  0.................  Numerator/
                                                                                               Denominator.
Patient Electronic Access.......  Provide Patient     Required..........  Up to 10%.........  Numerator/
                                   Access.                                                     Denominator.
                                  Patient-Specific    Not Required......  Up to 10%.........  Numerator/
                                   Education.                                                  Denominator.
Coordination of Care Through      View, Download, or  Not Required......  Up to 10%.........  Numerator/
 Patient Engagement.               Transmit (VDT).                                             Denominator.
                                  Secure Messaging..  Not Required......  Up to 10%.........  Numerator/
                                                                                               Denominator.
                                  Patient-Generated   Not Required......  Up to 10%.........  Numerator/
                                   Health Data.                                                Denominator.
Health Information Exchange.....  Send a Summary of   Required..........  Up to 10%.........  Numerator/
                                   Care **.                                                    Denominator.
                                  Request/Accept      Required..........  Up to 10%.........  Numerator/
                                   Summary of Care                                             Denominator.
                                   **.
                                  Clinical            Not Required......  Up to 10%.........  Numerator/
                                   Information                                                 Denominator.
                                   Reconciliation.
Public Health and Clinical Data   Immunization        Not Required......  0 or 10% *........  Yes/No Statement.
 Registry Reporting.               Registry
                                   Reporting.
                                  Syndromic           Not Required......  0 or 10%*.........  Yes/No Statement.
                                   Surveillance
                                   Reporting.
                                  Electronic Case     Not Required......  0 or 10%*.........  Yes/No Statement.
                                   Reporting.
                                  Public Health       Not Required......  0 or 10%*.........  Yes/No Statement.
                                   Registry
                                   Reporting.
                                  Clinical Data       Not Required......  0 or 10%*.........  Yes/No Statement.
                                   Registry
                                   Reporting.
----------------------------------------------------------------------------------------------------------------

[[Page 53677]]

 
                                                Bonus (up to 25%)
----------------------------------------------------------------------------------------------------------------
Report to one or more additional p5% bonusalth                            Yes/No Statement..
 agencies or clinical data registries beyond the one
 identified for the performance score.
Report improvement activities usin10% bonus.........                      Yes/No Statement..
Report using only 2015 Edition CEH10% bonus.........                      Based on measures
                                                                           submitted..
----------------------------------------------------------------------------------------------------------------
* A MIPS eligible clinician may earn 10 percent for each public health agency or clinical data registry to which
  the clinician reports, up to a maximum of 10 percent under the performance score.
** Exclusions are available for these measures.


  Table 8--2018 Performance Period Advancing Care Information Performance Category Scoring Methodology for 2018
                          Advancing Care Information Transition Objectives and Measures
----------------------------------------------------------------------------------------------------------------
                                    2018 advancing       Required/not
 2018 advancing care information   care information    required for base   Performance score       Reporting
      transition objective        transition measure      score (50%)         (Up to 90%)         requirement
----------------------------------------------------------------------------------------------------------------
Protect Patient Health            Security Risk       Required..........  0.................  Yes/No Statement.
 Information.                      Analysis.
Electronic Prescribing..........  E-Prescribing**...  Required..........  0.................  Numerator/
                                                                                               Denominator.
Patient Electronic Access.......  Provide Patient     Required..........  Up to 20%.........  Numerator/
                                   Access.                                                     Denominator.
                                  View, Download, or  Not Required......  Up to 10%.........  Numerator/
                                   Transmit (VDT).                                             Denominator.
Patient-Specific Education......  Patient-Specific    Not Required......  Up to 10%.........  Numerator/
                                   Education.                                                  Denominator.
Secure Messaging................  Secure Messaging..  Not Required......  Up to 10%.........  Numerator/
                                                                                               Denominator.
Health Information Exchange.....  Health              Required..........  Up to 20%.........  Numerator/
                                   Information**                                               Denominator.
                                   Exchange.
Medication Reconciliation.......  Medication          Not Required......  Up to 10%.........  Numerator/
                                   Reconciliation.                                             Denominator.
Public Health Reporting.........  Immunization        Not Required......  0 or 10%*.........  Yes/No Statement.
                                   Registry
                                   Reporting.
                                  Syndromic           Not Required......  0 or 10% *........  Yes/No Statement.
                                   Surveillance
                                   Reporting.
                                  Specialized         Not Required......  0 or 10% *........  Yes/No Statement.
                                   Registry
                                   Reporting.
----------------------------------------------------------------------------------------------------------------
                                                 Bonus up to 15%
----------------------------------------------------------------------------------------------------------------
Report to one or more additional public health agencies or clinical data  5% bonus..........  Yes/No Statement.
 registries beyond the one identified for the performance score.
Report improvement activities using CEHRT...............................  10% bonus.........  Yes/No Statement.
----------------------------------------------------------------------------------------------------------------
* A MIPS eligible clinician may earn 10% for each public health agency or clinical data registry to which the
  clinician reports, up to a maximum of 10% under the performance score.
** Exclusions are available for these measures.

    To facilitate readers in identifying the requirements of CEHRT for 
the Advancing Care Information Objectives and Measures, we are 
including the Table 9, which includes the 2015 Edition and 2014 Edition 
certification criteria required to meet the objectives and measures.

    Table 9--Advancing Care Information and Advancing Care Information Transition Objectives and Measures and
                                Certification Criteria for 2014 and 2015 Editions
----------------------------------------------------------------------------------------------------------------
             Objective                     Measure                2015 Edition                2014 Edition
----------------------------------------------------------------------------------------------------------------
Protect Patient Health Information  Security Risk          The requirements are a      The requirements are
                                     Analysis.              part of CEHRT specific to   included in the Base EHR
                                                            each certification          Definition.
                                                            criterion.
Electronic Prescribing............  e-Prescribing........  Sec.   170.315(b)(3)        Sec.   170.314(b)(3)
                                                            (Electronic Prescribing).   (Electronic
                                                            Sec.   170.315(a)(10)       Prescribing). Sec.
                                                            (Drug-Formulary and         170.314(a)(10) (Drug-
                                                            Preferred Drug List         Formulary and Preferred
                                                            checks.                     Drug List checks.

[[Page 53678]]

 
Patient Electronic Access.........  Provide Patient        Sec.   170.315(e)(1)        Sec.   170.314(e)(1)
                                     Access.                (View, Download, and        (View, Download, and
                                                            Transmit to 3rd Party).     Transmit to 3rd Party).
                                                            Sec.   170.315(g)(7)
                                                            (Application Access--
                                                            Patient Selection). Sec.
                                                             170.315(g)(8)
                                                            (Application Access--Data
                                                            Category Request). Sec.
                                                            170.315(g)(9)
                                                            (Application Access--All
                                                            Data Request). The three
                                                            criteria combined are the
                                                            ``API'' certification
                                                            criteria.
Patient Electronic Access/Patient   Patient Specific       Sec.   170.315(a)(13)       Sec.   170.314(a)(13)
 Specific Education.                 Education.             (Patient-specific           (Patient-specific
                                                            Education Resources).       Education Resources).
Coordination of Care Through        View, Download, or     Sec.   170.315(e)(1)        Sec.   170.314(e)(1)
 Patient Engagement/Patient          Transmit (VDT).        (View, Download, and        (View, Download, and
 Electronic Access.                                         Transmit to 3rd Party).     Transmit to 3rd Party).
                                                            Sec.   170.315(g)(7)
                                                            (Application Access--
                                                            Patient Selection). Sec.
                                                             170.315(g)(8)
                                                            (Application Access--Data
                                                            Category Request). Sec.
                                                            170.315(g)(9)
                                                            (Application Access--All
                                                            Data Request) The three
                                                            criteria combined are the
                                                            ``API'' certification
                                                            criteria.
Coordination of Care Through        Secure Messaging.....  Sec.   170.315(e)(2)        Sec.   170.314(e)(3)
 Patient Engagement.                                        (Secure Messaging).         (Secure Messaging).
Coordination of Care Through        Patient-Generated      Sec.   170.315(e)(3)        N/A.
 Patient Engagement.                 Health Data.           (Patient Health
                                                            Information Capture)
                                                            Supports meeting the
                                                            measure, but is NOT
                                                            required to be used to
                                                            meet the measure. The
                                                            certification criterion
                                                            is part of the CEHRT
                                                            definition beginning in
                                                            2018.
Health Information Exchange.......  Send a Summary of      Sec.   170.315(b)(1)        Sec.   170.314(b)(2)
                                     Care.                  (Transitions of Care).      (Transitions of Care-
                                                                                        Create and Transmit
                                                                                        Transition of Care/
                                                                                        Referral Summaries or
                                                                                        Sec.   170.314(b)(8)
                                                                                        (Optional--Transitions
                                                                                        of Care).
Health Information Exchange.......  Request/Accept         Sec.   170.315(b)(1)        Sec.   170.314(b)(1)
                                     Summary of Care.       (Transitions of Care).      (Transitions of Care-
                                                                                        Receive, Display and
                                                                                        Incorporate Transition
                                                                                        of Care/Referral
                                                                                        Summaries or Sec.
                                                                                        170.314(b)(8) (Optional--
                                                                                        Transitions of Care).
Health Information Exchange.......  Clinical Information   Sec.   170.315(b)(2)        Sec.   170.314(b)(4)
                                     Reconciliation.        (Clinical Information       (Clinical Information
                                                            Reconciliation and          Reconciliation or Sec.
                                                            Incorporation).             170.314(b)(9) (Optional--
                                                                                        Clinical Information
                                                                                        Reconciliation and
                                                                                        Incorporation).
Health Information Exchange.......  Health Information     N/A.......................  Sec.   170.314(b)(2)
                                     Exchange.                                          (Transitions of Care-
                                                                                        Create and Transmit
                                                                                        Transition of Care/
                                                                                        Referral Summaries or
                                                                                        Sec.   170.314(b)(8)
                                                                                        (Optional--Transitions
                                                                                        of Care).
Medication Reconciliation.........  Medication             N/A.......................  Sec.   170.314(b)(4)
                                     Reconciliation.                                    (Clinical Information
                                                                                        Reconciliation) or Sec.
                                                                                         170.314(b)(9)
                                                                                        (Optional-- Clinical
                                                                                        Information
                                                                                        Reconciliation and
                                                                                        Incorporation).
Public Health and Clinical Data     Immunization Registry  Sec.   170.315(f)(1)        N/A.
 Registry Reporting/Public Health    Reporting.             (Transmission to
 Reporting.                                                 Immunization Registries).
Public Health and Clinical Data     Syndromic              Sec.   170.315(f)(2)        Sec.   170.314(f)(3)
 Registry Reporting/Public Health    Surveillance           (Transmission to Public     (Transmission to Public
 Reporting.                          Reporting.             Health Agencies--           Health Agencies--
                                                            Syndromic Surveillance)     Syndromic Surveillance)
                                                            Urgent Care Setting Only.   or Sec.   170.314(f)(7)
                                                                                        (Optional-Ambulatory
                                                                                        Setting Only--
                                                                                        Transmission to Public
                                                                                        Health Agencies--
                                                                                        Syndromic Surveillance).
Public Health and Clinical Data     Electronic Case        Sec.   170.315(f)(5)        N/A.
 Registry Reporting.                 Reporting.             (Transmission to Public
                                                            Health Agencies--
                                                            Electronic Case
                                                            Reporting).
Public Health and Clinical Data     Public Health          EPs may choose one or more  Sec.   170.314(f)(5)
 Registry Reporting.                 Registry Reporting.    of the following: Sec.      (Optional--Ambulatory
                                                            170.315(f)(4)               Setting Only--Cancer
                                                            (Transmission to Cancer     Case Information and
                                                            Registries). Sec.           Sec.   170.314(f)(6)
                                                            170.315(f)(7)               (Optional--Ambulatory
                                                            (Transmission to Public     Setting Only--
                                                            Health Agencies--Health     Transmission to Cancer
                                                            Care Surveys).              Registries).
Public Health and Clinical Data     Clinical Data          No 2015 Edition health IT   N/A.
 Registry Reporting.                 Registry Reporting.    certification criteria at
                                                            this time.

[[Page 53679]]

 
Public Health Reporting...........  Specialized Registry   N/A.......................  Sec.   170.314(f)(5)
                                     Reporting.                                         (Optional--Ambulatory
                                                                                        Setting Only--Cancer
                                                                                        Case Information) and
                                                                                        Sec.   170.314(f)(6)
                                                                                        (Optional-- Ambulatory
                                                                                        Setting Only--
                                                                                        Transmission to Cancer
                                                                                        Registries).
----------------------------------------------------------------------------------------------------------------

(c) Exclusions
    We proposed to add exclusions to the measures associated with the 
Health Information Exchange and Electronic Prescribing Objectives 
required for the base score, as described below. We proposed these 
exclusions would apply beginning with the CY 2017 performance period.
Proposed Exclusion for the E-Prescribing Objective and Measure
Advancing Care Information Objective and Measure
    Objective: Electronic Prescribing.
    Objective: Generate and transmit permissible prescriptions 
electronically.
    E-Prescribing Measure: At least one permissible prescription 
written by the MIPS eligible clinician is queried for a drug formulary 
and transmitted electronically using CEHRT.
    Proposed Exclusion: Any MIPS eligible clinician who writes fewer 
than 100 permissible prescriptions during the performance period.
2017 and 2018 Advancing Care Information Transition Objective and 
Measure
    Objective: Electronic Prescribing.
    Objective: MIPS eligible clinicians must generate and transmit 
permissible prescriptions electronically.
    E-Prescribing Measure: At least one permissible prescription 
written by the MIPS eligible clinician is queried for a drug formulary 
and transmitted electronically using CEHRT.
    Proposed Exclusion: Any MIPS eligible clinician who writes fewer 
than 100 permissible prescriptions during the performance period.
Proposed Exclusion for the Health Information Exchange Objective and 
Measures Advancing Care Information Objective and Measures
    Objective: Health Information Exchange.
    Objective: The MIPS eligible clinician provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other health care clinician into their EHR using the functions of 
CEHRT.
    Send a Summary of Care Measure: For at least one transition of care 
or referral, the MIPS eligible clinician that transitions or refers 
their patient to another setting of care or health care clinician (1) 
creates a summary of care record using CEHRT; and (2) electronically 
exchanges the summary of care record.
    We note that we finalized our proposal to replace ``health care 
clinician'' with ``health care provider'' in the objective and measure.
    Proposed Exclusion: Any MIPS eligible clinician who transfers a 
patient to another setting or refers a patient is fewer than 100 times 
during the performance period.
    Request/Accept Summary of Care Measure: For at least one transition 
of care or referral received or patient encounter in which the MIPS 
eligible clinician has never before encountered the patient, the MIPS 
eligible clinician receives or retrieves and incorporates into the 
patient's record an electronic summary of care document.
    Proposed Exclusion: Any MIPS eligible clinician who receives 
transitions of care or referrals or has patient encounters in which the 
MIPS eligible clinician has never before encountered the patient fewer 
than 100 times during the performance period.
2017 and 2018 Advancing Care Information Transition Objective and 
Measures
    Objective: Health Information Exchange.
    Objective: The MIPS eligible clinician provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other health care clinicians into their EHR using the functions of 
CEHRT.
    Health Information Exchange Measure: The MIPS eligible clinician 
that transitions or refers their patient to another setting of care or 
health care clinician (1) uses CEHRT to create a summary of care 
record; and (2) electronically transmits such summary to a receiving 
health care clinician for at least one transition of care or referral.
    We note that we finalized our proposal to replace ``health care 
clinician'' with ``health care provider'' in the objective and measure.
    Proposed Exclusion: Any MIPS eligible clinician who transfers a 
patient to another setting or refers a patient fewer than 100 times 
during the performance period.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters overwhelmingly supported the addition of 
exclusions for the Electronic Prescribing, Health Information Exchange, 
Send a Summary of Care, and Request/Accept Summary of Care Measures.
    Response: We appreciate the support of the proposed modifications, 
and for the reasons discussed in the proposed rule, agree that it is 
appropriate to establish these exclusions.
    Comment: One commenter supported establishing exclusions but 
recommended that the thresholds be set at fewer than 200 instead of 
fewer than 100 as proposed.
    Response: We disagree. We proposed the exclusions because these 
measures may be outside a MIPS eligible clinician's licensing authority 
or outside their scope of practice. By claiming the exclusion, the MIPS 
eligible clinician is indicating that the measure is inapplicable to 
them, because they have few patients or insufficient number of actions 
that would allow calculation of the measure. We proposed the fewer than 
100 threshold to align with the exclusions for these measures that were 
established for the Medicare and Medicaid EHR Incentive Programs. We 
believe that the threshold of fewer than 100 will enable MIPS eligible 
clinicians

[[Page 53680]]

who do not prescribe, or transfer or refer patients or rarely do so to 
claim the exclusion(s) and still fulfill the base score of the 
advancing care information performance category. We believe a threshold 
of 200 is too high, and believe that a MIPS eligible clinician who is 
prescribing, transferring or referring more than 100 times during the 
performance period is taking the actions described in the measures 
often enough to be able to report on the measures for at least one 
patient to fulfil the base score requirement.
    Comment: One commenter was pleased to see CMS's intent to establish 
an exclusion for the e-Prescribing Measure. They stated that as doctors 
of chiropractic are statutorily prohibited in most states from 
prescribing medication, this measure created a great deal of concern 
over the last year that doctors of chiropractic would be adversely 
affected by not reporting this measure.
    Response: We did not intend to disadvantage chiropractors or other 
types of clinicians who may be prohibited by law from prescribing 
medication. We are establishing this exclusion for the e-Prescribing 
Measure beginning with the 2017 performance period.
    Comment: One commenter requested that if a MIPS eligible clinician 
claims an exclusion for the base score for the Health Information 
Exchange Measure, they should also be able to claim an exclusion for 
the performance score for this measure so their total advancing care 
information points are not adversely affected.
    Response: We disagree. MIPS eligible clinicians have many options 
to earn performance score points. If a measure is not applicable to a 
clinician, they have the flexibility to select other performance score 
measures on which to report.
    Comment: One commenter asked if these exclusions are available if 
reporting as a group.
    Response: Yes, MIPS eligible clinicians may claim the exclusion if 
they are reporting as a group. In the CY 2017 Quality Payment Program 
final rule (81 FR 77215), we stated that the group will need to 
aggregate data for all the individual MIPS eligible clinicians within 
the group for whom they have data in CEHRT, and if an individual MIP 
eligible clinician meets the criteria to exclude a measure, their data 
can be excluded from the calculation of that particular measure only.
    Comment: One commenter questioned whether clinicians who qualify to 
exclude these measures will be allowed to report on the measures. The 
commenter encouraged CMS to consider allowing these clinicians to 
exclude or to attest to the measures as they stated that both measures 
are key objectives in the advancing care information performance 
category and also stated that it will be beneficial to encourage 
clinicians to attest to both measures, even if they qualify to exclude 
them.
    Response: MIPS eligible clinicians may claim these exclusions if 
they qualify, although they do not have to claim the exclusions and may 
report on the measures if they choose to do so.
    Comment: One commenter requested that for the Request/Accept a 
Summary of Care Measure, that the exclusion be more closely tied to the 
logic for the denominator of that measure, so that the exclusion is 
specified in terms of new patients for whom a summary of care is 
available.
    Response: While we understand this concern, we disagree that the 
exclusion should be limited to new patients. While we believe the 
exclusion should include instances where the MIPS eligible clinician 
has never before encountered the patient, we do not want to limit it to 
just those instances.
    Final Action: After consideration of the public comments, we are 
finalizing these proposals as proposed. We note that the exclusions 
apply beginning with the 2017 performance period.
(7) Additional Considerations
(a) 21st Century Cures Act
    As we noted in the CY 2017 Quality Payment Program final rule (81 
FR 77238), section 101(b)(1)(A) of the MACRA amended section 
1848(a)(7)(A) of the Act to sunset the meaningful use payment 
adjustment at the end of CY 2018. Section 1848(a)(7) of the Act 
includes certain statutory exceptions to the meaningful use payment 
adjustment under section 1848(a)(7)(A) of the Act. Specifically, 
section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the 
application of the payment adjustment under section 1848(a)(7)(A) of 
the Act. In addition, section 1848(a)(7)(B) of the Act provides that 
the Secretary may, on a case-by-case basis, exempt an EP from the 
application of the payment adjustment under section 1848(a)(7)(A) of 
the Act if the Secretary determines, subject to annual renewal, that 
compliance with the requirement for being a meaningful EHR user would 
result in a significant hardship, such as in the case of an EP who 
practices in a rural area without sufficient internet access. The last 
sentence of section 1848(a)(7)(B) of the Act also provides that in no 
case may an exemption be granted under subparagraph (B) for more than 5 
years. The MACRA did not maintain these statutory exceptions for the 
advancing care information performance category of the MIPS. Thus, we 
had previously stated that the provisions 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.
    Following the publication of the CY 2017 Quality Payment Program 
final rule, the 21st Century Cures Act (Pub. L. 114-255) was enacted on 
December 13, 2016. Section 4002(b)(1)(B) of the 21st Century Cures Act 
amended section 1848(o)(2)(D) of the Act to state that the provisions 
of sections 1848(a)(7)(B) and (D) of the Act shall apply to assessments 
of MIPS eligible clinicians under section 1848(q) of the Act with 
respect to the performance category described in subsection 
(q)(2)(A)(iv) (the advancing care information performance category) in 
an appropriate manner which may be similar to the manner in which such 
provisions apply with respect to the meaningful use payment adjustment 
made under section 1848(a)(7)(A) of the Act. As a result of this 
legislative change, we believe that the general exceptions described 
under sections 1848(a)(7)(B) and (D) of the Act are applicable under 
the MIPS program. We included the proposals described below to 
implement these provisions as applied to assessments of MIPS eligible 
clinicians under section 1848(q) of the Act with respect to the 
advancing care information performance category.
(i) MIPS Eligible Clinicians Facing a Significant Hardship
    In the CY 2017 Quality Payment Program final rule (81 FR 77240 
through 77243), we recognized that there may not be sufficient measures 
applicable and available under the advancing care information 
performance category to MIPS eligible clinicians facing a significant 
hardship, such as those who lack sufficient internet connectivity, face 
extreme and uncontrollable circumstances, lack control over the 
availability of CEHRT, or do not have face-to-face interactions with 
patients. We relied on section 1848(q)(5)(F) of the Act to establish a 
final policy to assign a zero percent weighting to the advancing care 
information performance category in the final score if there are not 
sufficient measures and activities applicable and available to MIPS 
eligible clinicians within the categories of significant hardship noted 
above (81 FR 77243). Additionally, under the final policy (81 FR 
77243), we did not impose a limitation on the total number of MIPS 
payment years for which the advancing

[[Page 53681]]

care information performance category could be weighted at zero 
percent, in contrast with the 5-year limitation on significant hardship 
exceptions under the Medicare EHR Incentive Program as required by 
section 1848(a)(7)(B) of the Act.
    We did not propose substantive changes to this policy; however, as 
a result of the changes in the law made by the 21st Century Cures Act 
discussed above, we will not rely on section 1848(q)(5)(F) of the Act 
and instead proposed to use the authority in the last sentence of 
section 1848(o)(2)(D) of the Act for significant hardship exceptions 
under the advancing care information performance category under MIPS. 
Section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) 
of the 21st Century Cures Act, states in part that the provisions of 
section 1848(a)(7)(B) of the Act shall apply to assessments of MIPS 
eligible clinicians with respect to the advancing care information 
performance category in an appropriate manner which may be similar to 
the manner in which such provisions apply with respect to the payment 
adjustment made under section 1848(a)(7)(A) of the Act. We would assign 
a zero percent weighting to the advancing care information performance 
category in the MIPS final score for a MIPS payment year for MIPS 
eligible clinicians who successfully demonstrate a significant hardship 
through the application process. We would use the same categories of 
significant hardship and application process as established in the CY 
2017 Quality Payment Program final rule (81 FR 77240-77243). We would 
automatically reweight the advancing care information performance 
category to zero percent for a MIPS eligible clinician who lacks face-
to-face patient interaction and is classified as a non-patient facing 
MIPS eligible clinician without requiring an application. If a MIPS 
eligible clinician submits an application for a significant hardship 
exception or is classified as a non-patient facing MIPS eligible 
clinician, but also reports on the measures specified for the advancing 
care information performance category, they would be scored on the 
advancing care information performance category like all other MIPS 
eligible clinicians, and the category would be given the weighting 
prescribed by section 1848(q)(5)(E) of the Act regardless of the MIPS 
eligible clinician's score.
    As required under section 1848(a)(7)(B) of the Act, eligible 
professionals were not granted significant hardship exceptions for the 
payment adjustments under the Medicare EHR Incentive Program for more 
than 5 years. We proposed not to apply the 5-year limitation under 
section 1848(a)(7)(B) of the Act to significant hardship exceptions for 
the advancing care information performance category under MIPS.
    We solicited comments on the proposed use of the authority provided 
in the 21st Century Cures Act in section 1848(o)(2)(D) of the Act as it 
relates to application of significant hardship exceptions under MIPS 
and the proposal not to apply a 5-year limit to such exceptions.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters supported our proposal not to apply the 5-
year limit for significant hardship exceptions. Some commenters stated 
that the 5-year limit was arbitrary and should be eliminated. Other 
commenters stated that the issue causing the hardship may not be 
rectified within a 5-year period, and thus, could create undue burdens 
on the clinicians in the future. Assigning a zero percent weighting to 
the advancing care information performance category for those who 
successfully demonstrate a significant hardship through the application 
process would provide significant relief.
    Response: We thank commenters for their support and agree it is 
possible a clinician could experience a hardship for more than 5 years.
    Comment: One commenter suggested that under the EHR Incentive 
Program, a significant hardship exception would apply even if a health 
care provider attested to meaningful use. They requested that we not 
penalize eligible clinicians who choose to submit data, and to apply 
the exception if they qualify.
    Response: We disagree. Under the EHR Incentive Program, if a health 
care provider submits a request for or is otherwise granted a 
significant hardship exception, and also successfully attests to 
meaningful use, we would consider that provider to be a meaningful EHR 
user based on its attestation and thus would not apply the exception. 
Under MIPS, we continue to believe that this approach is warranted. If 
a MIPS eligible clinician chooses to submit data for the advancing care 
information performance category, they will be scored. As we explained 
in the CY 2017 Quality Payment Program final rule (81 FR 77241), we 
believe there may not be sufficient advancing care information measures 
applicable and available to MIPS eligible clinicians who experience a 
significant hardship, such as insufficient internet connectivity, 
extreme and uncontrollable circumstances, lack of control over the 
availability of CEHRT, and lack of face-to-face patient interaction. We 
believe that the submission of data indicates that there are sufficient 
measures applicable and available for the MIPS eligible clinician, and 
therefore, the significant hardship exception is not necessary.
    Comment: One commenter recommended that CMS outline more specific 
criteria for hardship exceptions because allowing too many exceptions 
could hinder adoption of the changes required to create a more 
efficient, value focused health care system. They suggested that 
hardship exceptions only be available for unusual and unique clinician 
circumstances.
    Response: While we understand the concern expressed in this 
comment, we decline to adopt narrower criteria for significant hardship 
exceptions at this time. We understand that the transition to MIPS has 
created challenges for MIPS eligible clinicians, and we believe the 
significant hardship exception policy we proposed would encourage more 
clinicians to participate successfully in the other performance 
categories of MIPS.
    Comment: One commenter questioned the proposed requirement to 
reapply for a hardship exception on an annual basis and recommended 
that exceptions should be granted for 2 years.
    Response: We disagree and believe it is appropriate to limit a 
hardship exception to 1 year. We want to encourage MIPS eligible 
clinicians to adopt and use CEHRT and allowing multi-year exceptions 
would not accomplish that goal. We believe that granting hardship 
exceptions for 1 year at a time will enable clinicians to work harder 
to successfully participate in the advancing care information 
performance category while knowing that there may be the possibility of 
receiving a significant hardship exception if it is needed and they 
qualify. Furthermore we have created a streamlined mechanism for the 
submission of Quality Payment Program Hardship Exception Applications. 
Applications that are submitted are reviewed on a rolling basis.
    Comment: One commenter expressed concern about occupational 
therapists participating in MIPS as they were never eligible for the 
EHR Incentive Program. They stated that many clinicians in solo or very 
small therapy practices cannot afford the expense of purchasing an EHR 
documentation system. For this reason, the commenter requested that in 
CY 2018 and future

[[Page 53682]]

years CMS grant them exceptions. Further, they recommended that CMS 
dedicate staff to engage therapists in an effort to provide consistent 
and targeted education regarding CEHRT requirements, applicable 
electronic measures, and other new criteria so they may be successful 
under the advancing care information performance category.
    Response: We appreciate this comment and point out that under 
section 1848(q)(1)(C)(i)(II) of the Act, additional eligible clinicians 
such as occupational therapists could be considered MIPS eligible 
clinicians starting in the third year of the program. If we decide to 
add additional clinician types to the definition of a MIPS eligible 
clinician, it would be proposed and finalized through notice and 
comment rulemaking. We would support these clinicians and help them to 
become successful program participants.
    Comment: One commenter expressed concern over the proposal to not 
apply the 5-year limit to significant hardship exceptions. They stated 
that although it is important to acknowledge circumstances outside of a 
clinician's control, it does not seem necessary to grant these hardship 
exceptions in perpetuity.
    Response: While we appreciate this comment, we disagree. We believe 
that a variety of circumstances may arise, and the application of the 
5-year limit could unfairly disadvantage MIPS eligible clinicians whose 
circumstances warrant a hardship exception. For example, a MIPS 
eligible clinician may lack control over the availability of CEHRT and 
apply annually for and receive a hardship exception for 5 years. If 
their practice is later significantly affected by a natural disaster, 
such as a hurricane, they would be unable to receive a hardship 
exception due to the 5-year limit, even though they would otherwise 
qualify for the exception.
    Comment: Commenters recommended adding additional hardship 
exception categories such as those eligible for Social Security 
benefits, those who have changed specialty taxonomy, those who practice 
in Tribal health care facilities and those who are solo practitioners.
    Response: While we appreciate the suggestions, we are declining to 
adopt these suggestions at this time. We will monitor performance on 
the advancing care information performance category to determine if 
additional hardship exception categories are appropriate. As we have 
previously stated, we do not believe that it is appropriate to reweight 
this category solely on the basis of a MIPS eligible clinicians' age or 
Social Security status, and believe that while other factors such as 
the lack of access to CEHRT or unforeseen environmental circumstances 
may constitute a significant hardship, the age of an MIPS eligible 
clinician alone or the preference to not obtain CEHRT does not. We note 
that solo practitioners would be included in the small practice 
significant hardship that we proposed at 82 FR 30076 so a separate 
hardship exception category for them is unnecessary.
    Final Action: After consideration of the comments we received, we 
are finalizing our policy as proposed.
(ii) Significant Hardship Exception for MIPS Eligible Clinicians in 
Small Practices
    Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to 
give consideration to the circumstances of small practices (consisting 
of 15 or fewer professionals) and practices located in rural areas and 
geographic HPSAs in establishing improvement activities under MIPS. In 
the CY 2017 Quality Payment Program final rule (81 FR 77187 through 
77188), we finalized that for MIPS eligible clinicians and groups that 
are in small practices or located in rural areas, or geographic health 
professional shortage areas (HPSAs), to achieve full credit under the 
improvement activities category, one high-weighted or two medium-
weighted improvement activities are required.
    While there is no corresponding statutory provision for the 
advancing care information performance category, we believe that 
special consideration should also be available for MIPS eligible 
clinicians in small practices. We proposed a significant hardship 
exception for the advancing care information performance category for 
MIPS eligible clinicians who are in small practices, under the 
authority in section 1848(o)(2)(D) of the Act, as amended by section 
4002(b)(1)(B) of the 21st Century Cures Act (see discussion of the 
statutory authority for significant hardship exceptions in section 
II.C.6.f.(7)(ii) of the proposed rule). We proposed that this hardship 
exception would be available to MIPS eligible clinicians in small 
practices as defined under Sec.  414.1305. We proposed in section 
II.C.1.e. of the proposed rule, that CMS would make eligibility 
determinations regarding the size of small practices for performance 
periods occurring in 2018 and future years. We proposed to reweight the 
advancing care information performance category to zero percent of the 
MIPS final score for MIPS eligible clinicians who qualify for this 
hardship exception. We proposed this exception would be available 
beginning with the 2018 performance period and 2020 MIPS payment year. 
We proposed a MIPS eligible clinician seeking to qualify for this 
exception would submit an application in the form and manner specified 
by us by December 31st of the performance period or a later date 
specified by us. We also proposed MIPS eligible clinicians seeking this 
exception must demonstrate in the application that there are 
overwhelming barriers that prevent the MIPS eligible clinician from 
complying with the requirements for the advancing care information 
performance category. In accordance with section 1848(a)(7)(B) of the 
Act, the exception would be subject to annual renewal. Under the 
proposal in section II.C.6.f.(7)(a) of the proposed rule, the 5-year 
limitation under section 1848(a)(7)(B) of the Act would not apply to 
this significant hardship exception for MIPS eligible clinicians in 
small practices.
    While we would be making this significant hardship exception 
available to small practices in particular, we are considering whether 
other categories or types of clinicians might similarly require an 
exception. We solicited comment on what those categories or types are, 
why such an exception is required, and any data available to support 
the necessity of the exception. We noted that supporting data would be 
particularly helpful to our consideration of whether any additional 
exceptions would be appropriate.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters supported and appreciated the significant 
hardship exception that we proposed for MIPS eligible clinicians in 
small practices. Many commenters stated that there are a number of 
administrative and financial barriers that small practices would be 
required to negotiate in order to be successful in the advancing care 
information performance category.
    Response: We appreciate this support and believe it is appropriate 
to provide a significant hardship exception for MIPS eligible 
clinicians in small practices, in part due to the barriers identified 
by the commenters.
    Comment: One commenter disagreed with our proposal to establish a 
significant hardship exception for small practices. They stated that 
while there are challenges that clinicians in small practices face in 
implementing HIT, well-implemented HIT can add to a practice's capacity 
to deliver high quality care. For a practice with limited support 
staff, HIT can make it easier for clinicians to communicate with their 
patients, know in real time about the

[[Page 53683]]

care their patients are receiving at other practices, and actively 
manage the population health of their entire patient panel. They 
recommended that CMS help and encourage small practices to adopt and 
meaningfully use HIT, rather than sending the message that HIT is a 
``significant hardship'' that small practices should consider avoiding.
    Response: While we agree that the use of HIT has many benefits and 
ideally all MIPS eligible clinicians would utilize CEHRT, we understand 
it may not be feasible at this time for all practices. We hope that 
over time more and more practices will realize the benefits of CEHRT 
and interoperability with other clinicians and successfully adopt and 
utilize CEHRT. We do offer no-cost technical assistance to small 
practices through the Small, Underserved, and Rural Support initiative. 
To find your local Small, Underserved, and Rural Support organization 
please review the Technical Assistance Resource Guide on qpp.cms.gov, 
or use the search feature on the ``Small Practices'' Web page.
    Comment: Some commenters recommended other significant hardship 
exceptions such as for MIPS eligible clinicians practicing in medically 
underserved areas or MIPS eligible clinicians caring for a medically 
underserved population.
    Response: We are adopting several policies in this final rule with 
comment period that will reduce its impact on small and solo practices, 
including the creation of a hardship exception for MIPS eligible 
clinicians in small practices. We will be monitoring participation in 
MIPS and in the advancing care information performance category to 
determine if it is appropriate to establish additional hardship 
exceptions for clinicians in medically underserved areas and those who 
serve underserved populations. Further, this final rule with comment 
period's provisions are designed to encourage participation, 
incentivize continuous improvement, and move participants on a glide 
path to improved health care delivery in the Quality Payment Program.
    Comment: One commenter applauded CMS for proposing a hardship 
exception for small practices and requested that CMS provide more 
assistance to small practices that are willing to try to integrate 
information technology. They stated the invaluable assistance provided 
by the Regional Extension Centers for the Medicare and Medicare EHR 
Incentive Programs.
    Response: We do offer no-cost technical assistance to small 
practices through the Small, Underserved, and Rural Support initiative. 
This initiative is comprised of 11 professional and experienced 
organizations who are ready to help clinicians in small practices and 
rural areas prepare for and participate in the Quality Payment Program. 
We try to ensure that priority is given to small practices in rural 
locations, health professional shortage areas, and medically 
underserved areas. The organizations within the Small, Underserved, and 
Rural Support initiative can help clinicians determine if they are 
included in the program, choose whether they will participate 
individually or as a part of a group, determine their data submission 
method, identify appropriate measures and activities, and much more. To 
find your local Small, Underserved, and Rural Support organization 
please review the Technical Assistance Resource Guide on qpp.cms.gov, 
or use the search feature on the ``Small Practices'' Web page.
    Comment: Commenters questioned the requirement that MIPS eligible 
clinicians must demonstrate that there are overwhelming barriers that 
prevent them from complying with the requirements of the advancing care 
information performance category. They believe that such a requirement 
is not clear or concise, and detracts from program goals.
    Response: We understand these concerns; however, we believe that 
adopting and implementing CEHRT may not be a significant hardship for 
some small practices. For small practices experiencing a significant 
hardship, we proposed that they demonstrate, through their application, 
there are overwhelming barriers to complying with the requirements of 
the advancing care information performance category. We do not 
anticipate any additional burden associated with this requirement as we 
do not intend to require documentation of the overwhelming barriers. 
While we sincerely hope that MIPS eligible clinicians will be able to 
successfully report for the advancing care information performance 
category, we understand that small practices do have challenges that 
would benefit from added flexibility and time to adopt CEHRT.
    Comment: One commenter recommended expanding the definition of 
small practice so that it is not limited to practices with 15 or fewer 
clinicians. Another suggested a threshold of 18 clinicians.
    Response: While we understand the concern that the proposed 
definition could be under-inclusive, we are not modifying our proposal. 
We believe it is more important to reduce burden by having one 
definition of small practice for the MIPS program and choose to align 
the definition for purposes of this significant hardship exception with 
the definition under Sec.  414.1305.
    Comment: Some commenters stated that practices located in rural 
areas often experience many of the same barriers as small practices 
such as financial limitations and workforce shortages. The effects of 
these challenges are magnified because clinicians in rural areas serve 
as critical access points for care and often provide a safety net for 
vulnerable populations. Commenters stated that CMS includes both small 
practices and practices located in rural areas in many of its policies 
proposed to reduce burden, including the low-volume threshold and 
flexibility under the improvement activities category, but neglected to 
include practices located in rural areas in its hardship exception 
proposal for advancing care information. Commenters believed this was 
an oversight and urged CMS to create a hardship exception for 
clinicians that practice in rural areas. Others requested that CMS 
modify the proposed advancing care information hardship exception so 
that it applies to both small practices and practices located in rural 
areas. They also requested that CMS make this an automatic exemption so 
as not to add to the burden of clinicians in these practices by 
requiring them to demonstrate ``overwhelming barriers'' to compliance. 
To recognize more advanced practices, the commenter suggested that CMS 
could offer an opt-in that would allow small and rural practices that 
believe they are prepared to participate in the advancing care 
information performance category to do so.
    Response: We disagree that the hardship exception should be 
``automatic'' for small practices because we believe many small 
practices will be able to successfully report on the advancing care 
information performance category. For those small practice that wish to 
apply for this significant hardship exception, we have simplified the 
application process for hardship exceptions under MIPS as compared with 
the process available for the Medicare EHR Incentive Program. We will 
be monitoring participation in MIPS and in the advancing care 
information performance category to determine if it is appropriate to 
establish an additional hardship exception for clinicians practicing in 
rural areas in future rulemaking.
    Final Action: After consideration of the comments that we received, 
we are adopting our policy as proposed.

[[Page 53684]]

(iii) Hospital-Based MIPS Eligible Clinicians
    In the CY 2017 Quality Payment Program final rule (81 FR 77238 
through 77240), we defined a hospital-based MIPS eligible clinician 
under Sec.  414.1305 as a MIPS eligible clinician who furnishes 75 
percent or more of his or her covered professional services in sites of 
service identified by the Place of Service (POS) codes used in the 
HIPAA standard transaction as an inpatient hospital (POS 21), on-campus 
outpatient hospital (POS 22), or emergency room (POS 23) setting, based 
on claims for a period prior to the performance period as specified by 
CMS. We discussed our assumption that MIPS eligible clinicians who are 
determined hospital-based do not have sufficient advancing care 
information measures applicable to them, and we established a policy to 
reweight the advancing care information performance category to zero 
percent of the MIPS final score for the MIPS payment year in accordance 
with section 1848(q)(5)(F) of the Act (81 FR 77240).
    We did not propose substantive changes to this policy; however, as 
a result of the changes in the law made by the 21st Century Cures Act 
discussed above, we will not rely on section 1848(q)(5)(F) of the Act 
and instead proposed to use the authority in the last sentence of 
section 1848(o)(2)(D) of the Act for exceptions for hospital-based MIPS 
eligible clinicians under the advancing care information performance 
category. Section 1848(o)(2)(D) of the Act, as amended by section 
4002(b)(1)(B) of the 21st Century Cures Act, states in part that the 
provisions of section 1848(a)(7)(D) of the Act shall apply to 
assessments of MIPS eligible clinicians with respect to the advancing 
care information performance category in an appropriate manner which 
may be similar to the manner in which such provisions apply with 
respect to the payment adjustment made under section 1848(a)(7)(A) of 
the Act. We would assign a zero percent weighting to the advancing care 
information performance category in the MIPS final score for a MIPS 
payment year for hospital-based MIPS eligible clinicians as previously 
defined. A hospital-based MIPS eligible clinician would have the option 
to report the advancing care information measures for the performance 
period for the MIPS payment year for which they are determined 
hospital-based. However, if a MIPS eligible clinician who is determined 
hospital-based chooses to report on the advancing care information 
measures, they would be scored on the advancing care information 
performance category like all other MIPS eligible clinicians, and the 
category would be given the weighting prescribed by section 
1848(q)(5)(E) of the Act regardless of their score.
    We proposed to amend Sec.  414.1380(c)(1) and (2) of the regulation 
text to reflect this proposal.
    We requested comments on the proposed use of the authority provided 
in the 21st Century Cures Act in section 1848(o)(2)(D) of the Act as it 
relates to hospital-based MIPS eligible clinicians.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter recommended that this policy be effective as 
soon as possible.
    Response: We note that this policy would apply beginning with the 
first year of the Quality Payment Program, the 2017 performance period. 
We did not propose substantive changes to our existing policy for 
hospital-based MIPS eligible clinicians; rather, we proposed to rely on 
different statutory authority for the policy.
    Comment: The majority of commenters supported our proposal. Many 
stated that there are insufficient measures applicable and available to 
hospital-based MIPS eligible clinicians for the advancing care 
information performance category of MIPS.
    Response: We appreciate the support of commenters. We continue to 
believe that hospital-based MIPS eligible clinicians may not have 
control over the decisions that the hospital makes regarding the use of 
health IT and CEHRT. These MIPS eligible clinicians therefore may have 
no control over the type of CEHRT available, the way that the 
technology is implemented and used, or whether the hospital continually 
invests in the technology to ensure it is compliant with ONC 
certification criteria.
    Comment: Commenters urged us to be transparent and give MIPS 
eligible clinicians timely notice well in advance of the start of the 
performance period whether or not they are hospital-based and therefore 
not required to participate in the advancing care information 
performance category.
    Response: We agree. We want to inform MIPS eligible clinicians as 
soon as possible of their hospital-based status. Unfortunately, in this 
first year of the Quality Payment Program, we were unable to provide 
this information as soon as we had hoped. It became available in August 
2017, but for future performance periods it is expected that the 
information will be available sooner.
    Comment: Commenters stated that under the current hospital-based 
group definition, if less than 100 percent of the clinicians in a group 
are considered hospital-based, then the group is expected to submit 
advancing care information performance category data for the portion of 
clinicians who are not hospital-based, even if that is only a small 
percentage. Commenters stated they believe the intent of the group 
reporting option is to ease the administrative burden of reporting on 
behalf of an entire group. Commenters also stated it is unreasonable to 
expect a group, where the majority of clinicians are hospital-based, to 
parse out the minority of clinicians who are not hospital-based and to 
report their advancing care information performance category data to 
CMS.
    They suggested that CMS adopt a policy whereby if the simple 
majority of the group's clinicians meet the definition of hospital-
based, as individuals, then the group as a whole would be exempt from 
the advancing care information performance category.
    Response: We disagree and note that the group would not be expected 
to parse out any data, but would instead report the aggregated data of 
the entire group (hospital-based MIPS eligible clinicians included), 
thus, there would be no additional burden to prepare the data for 
reporting. We direct readers to the discussion of Scoring for MIPS 
Eligible Clinicians in Groups in section II.6.f(c)(7) of this final 
rule with comment period.
    Final Action: After consideration of the comments we received, we 
are finalizing our policy as proposed. We will amend Sec.  
414.1380(c)(1) and (2) of the regulation text to reflect this policy.
(iv) Ambulatory Surgical Center (ASC)--Based MIPS Eligible Clinicians
    Section 16003 of the 21st Century Cures Act amended section 
1848(a)(7)(D) of the Act to provide that no payment adjustment may be 
made under section 1848(a)(7)(A) of the Act for 2017 and 2018 in the 
case of an eligible professional who furnishes substantially all of his 
or her covered professional services in an ambulatory surgical center 
(ASC). Section 1848(a)(7)(D)(iii) of the Act provides that 
determinations of whether an eligible professional is ASC-based may be 
made based on the site of service as defined by the Secretary or an 
attestation, but shall be made without regard to any employment or 
billing arrangement between the eligible professional and any other 
supplier or provider of services. Section 1848(a)(7)(D)(iv) of the Act 
provides that

[[Page 53685]]

the ASC-based exception shall no longer apply as of the first year that 
begins more than 3 years after the date on which the Secretary 
determines, through notice and comment rulemaking, that CEHRT 
applicable to the ASC setting is available.
    Under section 1848(o)(2)(D) of the Act, as amended by section 
4002(b)(1)(B) of the 21st Century Cures Act, the ASC-based provisions 
of section 1848(a)(7)(D) of the Act shall apply to assessments of MIPS 
eligible clinicians under section 1848(q) of the Act with respect to 
the advancing care information performance category in an appropriate 
manner which may be similar to the manner in which such provisions 
apply with respect to the payment adjustment made under section 
1848(a)(7)(A) of the Act. We believe the proposals for ASC-based MIPS 
eligible clinicians are an appropriate application of the provisions of 
section 1848(a)(7)(D) of the Act to MIPS eligible clinicians. Under the 
Medicare EHR Incentive Program an approved hardship exception exempted 
an EP from the payment adjustment. We believe that weighting the 
advancing care information performance category to zero percent is 
similar in effect to an exemption from the requirements of that 
performance category.
    To align with our hospital-based MIPS eligible clinician policy, we 
proposed to define at Sec.  414.1305 an ASC-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) code 24 used in the HIPAA 
standard transaction based on claims for a period prior to the 
performance period as specified by us. We requested comments on this 
proposal and solicit comments as to whether other POS codes should be 
used to identify a MIPS eligible clinician's ASC-based status or if an 
alternative methodology should be used. We noted that the ASC-based 
determination will be made independent of the hospital-based 
determination.
    To determine a MIPS eligible clinician's ASC-based status, we 
proposed to use claims with dates of service between September 1 of the 
calendar year 2 years preceding the performance period through August 
31 of the calendar year preceding the performance period, but in the 
event it is not operationally feasible to use claims from this time 
period, we would use a 12-month period as close as practicable to this 
time period. We proposed this timeline to allow us to notify MIPS 
eligible clinicians of their ASC-based status prior to the start of the 
performance period and to align with the hospital-based MIPS eligible 
clinician determination period. For the 2019 MIPS payment year, we 
would not be able to notify MIPS eligible clinicians of their ASC-based 
status until after the final rule with comment period is published, 
which we anticipate would be later in 2017. We expect that we would 
provide this notification through QPP.cms.gov.
    For MIPS eligible clinicians who we determine are ASC-based, we 
proposed to assign a zero percent weighting to the advancing care 
information performance category in the MIPS final score for the MIPS 
payment year. However, if a MIPS eligible clinician who is determined 
ASC-based chooses to report on the Advancing Care Information Measures 
or the Advancing Care Information Transition Measures, if applicable, 
for the performance period for the MIPS payment year for which they are 
determined ASC-based, we proposed they would be scored on the advancing 
care information performance category like all other MIPS eligible 
clinicians, and the performance category would be given the weighting 
prescribed by section 1848(q)(5)(E) of the Act regardless of their 
advancing care information performance category score.
    We proposed these ASC-based policies would apply beginning with the 
2017 performance period/2019 MIPS payment year.
    We proposed to amend Sec.  414.1380(c)(1) and (2) of the regulation 
text to reflect these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter requested that the ASC-based MIPS eligible 
clinician determination be added to the hospital-based determination so 
that we would make a determination based on the sum of services 
performed in an ASC, inpatient hospital, emergency room and on-campus 
outpatient hospital as they believe that application is in line with 
congressional intent.
    Response: We disagree. We proposed that the ASC-based MIPS eligible 
clinician determination be made separately from the hospital-based 
determination because section 1848(a)(7)(D) of the Act, as amended by 
section 16003 of the 21st Century Cures Act, distinguishes between 
hospital-based and ASC-based clinicians, and continue to believe this 
approach is most consistent with the statute. However, we note that the 
commenter incorrectly described our hospital-based policy by stating we 
determine a clinician's status based on one setting. To determine if a 
MIPS eligible clinician is hospital-based, we currently consider the 
percentage of covered professional services furnished in POS codes 21, 
22, and 23 collectively and not separately.
    Comment: One commenter urged CMS to allow ASC-based MIPS eligible 
clinicians the ability to apply for a significant hardship exception to 
reweight their advancing care information performance category score 
even if their ASC-based status changes subsequent to the deadline to 
apply for the significant hardship exception. The commenter stated that 
these clinicians likely would not have control over the CEHRT in their 
practice and should have their advancing care information performance 
category score reweighted to zero.
    Response: We note that we will make the determination about whether 
a MIPS eligible clinician is ASC-based by looking claims with dates of 
service between September 1 of the calendar year 2 years preceding the 
performance period through August 31 of the calendar year preceding the 
performance period. It is our intent to make determinations prior to 
the close of the submission period for significant hardship exceptions.
    Final Action: After consideration of the comments we received, we 
are finalizing our policy as proposed. We are amending Sec.  414.1305 
and Sec.  414.1380(c)(1) and (2) to reflect this policy.
(v) Exception for MIPS Eligible Clinicians Using Decertified EHR 
Technology
    Section 4002(b)(1)(A) of the 21st Century Cures Act amended section 
1848(a)(7)(B) of the Act to provide that the Secretary shall exempt an 
eligible professional from the application of the payment adjustment 
under section 1848(a)(7)(A) of the Act with respect to a year, subject 
to annual renewal, if the Secretary determines that compliance with the 
requirement for being a meaningful EHR user is not possible because the 
CEHRT used by such professional has been decertified under ONC's Health 
IT Certification Program. Section 1848(o)(2)(D) of the Act, as amended 
by section 4002(b)(1)(B) of the 21st Century Cures Act, states in part 
that the provisions of section 1848(a)(7)(B) of the Act shall apply to 
assessments of MIPS eligible clinicians with respect to the advancing 
care information performance category in an appropriate manner which 
may be similar to the manner in which such provisions apply with 
respect to the

[[Page 53686]]

payment adjustment made under section 1848(a)(7)(A) of the Act.
    We proposed that a MIPS eligible clinician may demonstrate through 
an application process that reporting on the measures specified for the 
advancing care information performance category is not possible because 
the CEHRT used by the MIPS eligible clinician has been decertified 
under ONC's Health IT Certification Program. We proposed that if the 
MIPS eligible clinician's demonstration is successful and an exception 
is granted, we would assign a zero percent weighting to the advancing 
care information performance category in the MIPS final score for the 
MIPS payment year. In accordance with section 1848(a)(7)(B) of the Act, 
the exception would be subject to annual renewal, and in no case may a 
MIPS eligible clinician be granted an exception for more than 5 years. 
We proposed this exception would be available beginning with the CY 
2018 performance period and the 2020 MIPS payment year.
    We proposed that a MIPS eligible clinician may qualify for this 
exception if their CEHRT was decertified either during the performance 
period for the MIPS payment year or during the calendar year preceding 
the performance period for the MIPS payment year. In addition, we 
proposed that the MIPS eligible clinician must demonstrate in their 
application and through supporting documentation if available that the 
MIPS eligible clinician made a good faith effort to adopt and implement 
another CEHRT in advance of the performance period. We proposed a MIPS 
eligible clinician seeking to qualify for this exception would submit 
an application in the form and manner specified by us by December 31st 
of the performance period, or a later date specified by us.
    We proposed to amend Sec.  414.1380(c)(1) and (2) of the regulation 
text to reflect these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters supported the creation of a hardship exception 
for clinicians whose EHR becomes decertified. One commenter stated that 
the proposal was a sensible approach that supports clinicians who 
encounter serious issues with EHR technology that are outside their 
control.
    Response: We appreciate the support of commenters for this 
proposal.
    Comment: One commenter recommended that clinicians be held harmless 
in an automated fashion if there CEHRT becomes decertified. The 
commenter expressed concern that the terms ``made a good faith effort'' 
and ``through supporting documentation'' are vague and requested 
further guidance.
    Response: While we understand the concern, MIPS eligible clinicians 
frequently change EHR vendors, and we would not know that they are 
using a product that has been decertified unless they notified CMS. We 
have a fairly simple system through which MIPS eligible clinicians may 
apply for an exception. Documentation does not need to be submitted 
with the application, but MIPS eligible clinicians should retain 
documentation that supports their request for an exception based on 
decertified EHR technology.
    Comment: One commenter recommended that we communicate the 
availability of this hardship exception for clinicians who learn that 
their CEHRT does not conform to the ONC certification requirements.
    Response: We plan to add this decertification exception category to 
the Quality Payment Program Hardship Exception Application on 
qpp.cms.gov.
    Comment: One commenter urged CMS to use at least a 2-year exemption 
period and allow clinicians to seek additional time if necessary before 
they are subject to the advancing care information performance category 
reporting requirements. A few commenters stated it was more appropriate 
to allow a 3-year exemption period because of the time necessary to 
acquire a new system, move data, redesign workflows and train clinical 
and administrative staffs.
    Response: All exceptions for the advancing care information 
performance category are approved for 1 year only, and the exception 
application would be subject to annual renewal. We stated that MIPS 
eligible clinician may qualify for this exception if their CEHRT was 
decertified either during the performance period for the MIPS payment 
year or during the calendar year preceding the performance period for 
the MIPS payment year. If the transition to a new CEHRT takes much 
longer than expected for reasons beyond the clinician's control, they 
could potentially apply for a significant hardship exception based on 
extreme and uncontrollable circumstances.
    Comment: Several commenters recommended expanding this proposal to 
include CEHRT that has its certification suspended. Commenters 
indicated a suspension would occur only when ONC identifies that CEHRT 
poses a ``potential risk to public health or safety''.
    Response: While we understand these concerns, section 1848(a)(7)(B) 
of the Act, as amended by section 4002(b)(1)(A) of the 21st Century 
Cures Act, provides authority for an exception in the event of 
decertification, not suspension of certification.
    Final Action: After consideration of the comments we received, we 
are finalizing our policy as proposed. We are amending Sec.  
414.1380(c)(1) and (2) of the regulation text to reflect this policy.
(b) Hospital-Based MIPS Eligible Clinicians
    In the CY 2017 Quality Payment Program final rule (81 FR 77238 
through 77240, we defined 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 services identified by the 
Place of Service (POS) codes used in the HIPAA standard transaction as 
an inpatient hospital (POS 21), on campus outpatient hospital (POS 22) 
or emergency room (POS 23) setting, based on claims for a period prior 
to the performance period as specified by CMS.
    We proposed to modify our policy to include covered professional 
services furnished by MIPS eligible clinicians in an off-campus-
outpatient hospital (POS 19) in the definition of hospital-based MIPS 
eligible clinician. POS 19 was developed in 2015 in order to capture 
the numerous physicians that are paid for a portion of their services 
in an ``off campus-outpatient hospital'' versus an on campus-outpatient 
hospital, (POS 22). We also believe that these MIPS eligible clinicians 
would not typically have control of the development and maintenance of 
their EHR systems, just like those who bill using POS 22. We proposed 
to add POS 19 to our existing definition of a hospital-based MIPS 
eligible clinician beginning with the performance period in 2018.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters expressed their support for the addition of 
off-campus-outpatient hospital (POS 19) to the definition of hospital-
based.
    Response: We appreciate the support and believe it is appropriate 
to add off-campus-outpatient hospital (POS 19) in the definition of 
hospital-based MIPS eligible clinician because this setting is similar 
to the on-campus outpatient hospital setting in that the MIPS eligible 
clinicians lack control over CEHRT.
    Comment: A few commenters urged CMS to automatically reweight the 
advancing care information performance category for clinicians who 
predominantly practice in settings such as Comprehensive Inpatient

[[Page 53687]]

Rehabilitation Facility (IRF; POS 61) and Skilled Nursing Facility 
(SNF: POS 31) as clinicians who practice in these settings will 
struggle to meet advancing care information requirements much like 
inpatient hospital-based eligible clinicians. For example, they may not 
have control over the decisions that the facilities make regarding the 
use of health IT and CEHRT, and requirements under the Protect Patient 
Health Information Objective to conduct a security risk analysis would 
rely on the actions of the facilities, rather than the actions of the 
MIPS eligible clinicians.
    Response: We thank the commenters for bringing these settings to 
our attention, and although we did not include them in our proposals, 
we will monitor MIPS participation of clinicians who practice in these 
settings to determine if they are able to meet the requirements of the 
advancing care information performance category.
    Final Action: After consideration of the public comments, we are 
adopting our proposal as proposed.
(c) Scoring for MIPS Eligible Clinicians in Groups
    In any of the situations described in the sections above, we would 
assign a zero percent weighting to the advancing care information 
performance category in the MIPS final score for the MIPS payment year 
if the MIPS eligible clinician meets certain specified requirements for 
this weighting. We noted that these MIPS eligible clinicians may choose 
to submit Advancing Care Information Measures or the Advancing Care 
Information Transition Measures, if applicable; however, if they choose 
to report, they will be scored on the advancing care information 
performance category like all other MIPS eligible clinicians and the 
performance category will be given the weighting prescribed by section 
1848(q)(5)(E) of the Act regardless of their advancing care information 
performance category score. This policy includes MIPS eligible 
clinicians choosing to report as part of a group or part of a virtual 
group.
    Groups as defined at Sec.  414.1310(e)(1) are required to aggregate 
their performance data across the TIN in order for their performance to 
be assessed as a group (81 FR 77058). Additionally, groups that elect 
to have their performance assessed as a group will be assessed as a 
group across all four MIPS performance categories. By reporting as part 
of a group, MIPS eligible clinicians are subscribing to the data 
reporting and scoring requirements of the group. We noted that the data 
submission criteria for groups reporting advancing care information 
performance category described in the CY 2017 Quality Payment Program 
final rule (81 FR 77215) state that group data should be aggregated for 
all MIPS eligible clinicians within the group. This includes those MIPS 
eligible clinicians who may qualify for a zero percent weighting of the 
advancing care information performance category due to the 
circumstances as described above, such as a significant hardship or 
other type of exception, hospital-based or ASC-based status, or certain 
types of non-physician practitioners (NPs, PAs, CNSs, and CRNAs). If 
these MIPS eligible clinicians report as part of a group or virtual 
group, they will be scored on the advancing care information 
performance category like all other MIPS eligible clinicians and the 
performance category will be given the weighting prescribed by section 
1848(q)(5)(E) of the Act regardless of the group's advancing care 
information performance category score.
    The following is a summary of the public comments received and our 
responses:
    Comment: One commenter urged CMS not to finalize this policy and 
instead to reweight the advancing care information category to zero 
percent for any group or virtual group in which the majority of 
individual clinicians would be exempt from scoring in that category. 
Another commenter suggested that groups should have the option to 
include or to not include data from non-patient facing and hospital-
based MIPS eligible clinicians in their aggregated advancing care 
information performance category data.
    Response: We did not propose any changes to our policy related to 
MIPS eligible clinicians in groups. We were simply restating the policy 
finalized for groups reporting data for the advancing care information 
performance category as described in the CY 2017 Quality Payment 
Program final rule (81 FR 77215) that group data should be aggregated 
for all MIPS eligible clinicians within the group. This includes those 
MIPS eligible clinicians who may qualify for a zero percent weighting 
of the advancing care information performance category based on a 
significant hardship or other type of exception, hospital-based or ASC-
based status, or certain types of non-physician practitioners (NPs, 
PAs, CNSs, and CRNAs). Our policy is 100 percent of the MIPS eligible 
clinicians in the group must qualify for a zero percent weighting in 
order for the advancing care information performance category to be 
reweighted in the final score.
    Comment: One commenter requested clarification as to how the 
advancing care information performance category of MIPS applies to 
group reporting. Specifically, the commenter stated that CMS' 
regulations and guidance are unclear as to whether it is permissible 
for a MIPS eligible clinician who participates in group reporting to 
not utilize CEHRT without disqualifying the entire group from 
attempting to report successfully on the advancing care information 
performance category. Another commenter asked if groups are able to 
report their advancing care information data by aggregating data for 
the entire TIN and including a denominator value only for the patients 
who were seen in a location with the use of CEHRT, or if the whole 
group would receive a zero for the advancing care information 
performance category because not all MIPS eligible clinicians in the 
group use CEHRT.
    Response: In the CY 2017 Quality Payment Program final rule (81 FR 
77215), we stated that the group will need to aggregate data for all 
the individual MIPS eligible clinicians within the group for whom they 
have data in CEHRT. The group should submit the data that they have in 
CEHRT and exclude data not collected from a non-certified EHR system. 
While we do not expect that every MIPS eligible clinician in the group 
will have access to CEHRT, or that every measure will apply to every 
clinician in the group, only those data contained in CEHRT should be 
reported for the advancing care information performance category.
    We will take these comments into consideration and may address the 
issues raised in future rulemaking.
(d) Timeline for Submission of Reweighting Applications
    In the CY 2017 Quality Payment Program final rule (81 FR 77240-
77243), we established the timeline for the submission of applications 
to reweight the advancing care information performance category in the 
MIPS final score to align with the data submission timeline for MIPS. 
We established that all applications for reweighting the advancing care 
information performance category be submitted by the MIPS eligible 
clinician or designated group representative in the form and manner 
specified by us. All applications may be submitted on a rolling basis, 
but must be received by us no later than the close of the submission 
period for the relevant performance period, or a later date specified 
by us. An application would need to be submitted annually to be 
considered for reweighting each year.

[[Page 53688]]

    The Quality Payment Program Exception Application will be used to 
apply for the following exceptions: Insufficient Internet Connectivity; 
Extreme and Uncontrollable Circumstances; Lack of Control over the 
Availability of CEHRT; Decertification of CEHRT; and Small Practice.
    We proposed to change the submission deadline for the application 
as we believe that aligning the data submission deadline with the 
reweighting application deadline could disadvantage MIPS eligible 
clinicians. We proposed to change the submission deadline for the CY 
2017 performance period to December 31, 2017, or a later date specified 
by us. We believe this change would help MIPS eligible clinicians by 
allowing them to learn whether their application is approved prior to 
the data submission deadline for the CY 2017 performance period, March 
31, 2018. We noted that if a MIPS eligible clinician submits data for 
the advancing care information performance category after an 
application has been submitted, the data would be scored, the 
application would be considered voided and the advancing care 
information performance category would not be reweighted.
    We further proposed that the submission deadline for the 2018 
performance period will be December 31, 2018, or a later date as 
specified by us. We believe this would help MIPS eligible clinicians by 
allowing them to learn whether their application is approved prior to 
the data submission deadline for the CY 2018 performance period, March 
31, 2019.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter requested that MIPS eligible clinicians be 
able to submit applications throughout the performance period and did 
not support the change to the application deadline. Another commenter 
suggested that MIPS eligible clinicians should be able to submit their 
applications throughout the performance period and receive a timely 
response from CMS.
    Response: We agree that MIPS eligible clinicians should be able to 
submit applications throughout the performance period. Under our 
proposal, MIPS eligible clinicians could submit applications anytime 
during CY 2017, which is the performance period. We believe that if the 
application submission period is open during the data submission 
period, MIPS eligible clinicians may not know whether their application 
is approved prior to the data submission period, and thus we proposed 
to change the application submission deadline to align with the end of 
the performance period.
    Comment: Commenters supported the change in the application 
submission deadline because it will reduce the reporting burden for 
those who are approved for a hardship exception.
    Response: We appreciate the support for our proposal.
    Comment: One commenter recommended that the submission deadline for 
hardship exceptions be changed to July 31, 2018 as they stated that the 
inclusion of the phrase ``or at a later date specified by us'' 
indicates that CMS acknowledges that the December 31st deadline may not 
be appropriate.
    Response: We disagree. We believe that it is appropriate to align 
the submission period for hardship exception applications with the 
performance period so that MIPS eligible clinicians will know whether 
their application was approved prior to the MIPS data submission 
deadline.
    Final Action: After consideration of the public comments, we are 
adopting our policy as proposed. We note that the submission of Quality 
Payment Program Hardship Exception Applications began during the 2017 
performance period (in August 2017) and will close at the end of the 
calendar year 2017.
g. APM Scoring Standard for MIPS Eligible Clinicians in MIPS APMs
(1) Overview
    Under section 1848(q)(1)(C)(ii)(1) of the Act, Qualifying APM 
Participants (QPs) are not MIPS eligible clinicians and are thus 
excluded from MIPS reporting requirements and payment adjustments. 
Similarly, under section 1848(q)(1)(c)(ii)(II) of the Act, Partial 
Qualifying APM Participants (Partial QPs) are also not MIPS eligible 
clinicians unless they opt to report and be scored under MIPS. All 
other MIPS eligible clinicians, including those participating in MIPS 
APMs, are subject to MIPS reporting requirements and payment 
adjustments unless they are excluded on another basis such as being 
newly enrolled in Medicare or not exceeding the low volume threshold.
    In the CY 2017 Quality Payment Program final rule, we finalized the 
APM scoring standard, which is designed to reduce reporting burden for 
participants in certain APMs by minimizing the need for them to make 
duplicative data submissions for both MIPS and their respective APMs 
(81 FR 77246 through 77269, 77543). We also sought to ensure that MIPS 
eligible clinicians in APM Entities that participate in certain types 
of APMs that assess their participants on quality and cost are assessed 
as consistently as possible across MIPS and their respective APMs. 
Given that many APMs already assess their participants on cost and 
quality of care and require engagement in certain improvement 
activities, we believe that without the APM scoring standard, 
misalignments could be quite common between the evaluation of 
performance under the terms of the APM and evaluation of performance on 
measures and activities under MIPS.
    In the CY 2017 Quality Payment Program final rule, we identified 
the types of APMs for which the APM scoring standard would apply as 
MIPS APMs (81 FR 77249). We finalized at Sec.  414.1370(b) that to be a 
MIPS APM, an APM must satisfy the following criteria: (1) APM Entities 
participate in the APM under an agreement with CMS or by law or 
regulation; (2) the APM requires that APM Entities include at least one 
MIPS eligible clinician on a Participation List; (3) the APM bases 
payment incentives on performance (either at the APM Entity or eligible 
clinician level) on cost/utilization and quality measures; and (4) the 
APM is not either a new APM for which the first performance period 
begins after the first day of the MIPS performance period for the year 
or an APM in the final year of operation for which the APM scoring 
standard is impracticable. We specified that we will post the list of 
MIPS APMs prior to the first day of the MIPS performance period for 
each year, though we expect that any new models would likely be 
announced 2 or more months before the start of the performance period 
for a year (81 FR 77250). We finalized in our regulations at Sec.  
414.1370(b) that for a new APM to be a MIPS APM, its first performance 
period must start on or before the first day of the MIPS performance 
period. A list of MIPS APMs is available at www.qpp.cms.gov.
    We also note that while it is possible to be both a MIPS APM and an 
Advanced APM, the criteria for the two are distinct, and a 
determination that an APM is an Advanced APM does not guarantee that it 
will be a MIPS APM and vice versa. We refer eligible clinicians to our 
Web site, qpp.cms.gov, for more information about participating in MIPS 
APMs and Advanced APMs.
    We established in the regulations at Sec.  414.1370(c) that the 
MIPS performance period under Sec.  414.1320 of our regulations applies 
for the APM scoring standard.
    We finalized that under section Sec.  414.1370(f) of our 
regulations, for the APM scoring standard, MIPS eligible clinicians 
will be scored at the APM

[[Page 53689]]

Entity group level, and each MIPS eligible clinician will receive the 
APM Entity group's final score. The MIPS payment adjustment is applied 
at the TIN/NPI level for each of the MIPS eligible clinicians in the 
APM Entity. The MIPS final score is comprised of the four MIPS 
performance category scores, as described in our regulation at Sec.  
414.1370(g): Quality, cost, improvement activities, and advancing care 
information. Both the Medicare Shared Savings Program and Next 
Generation ACO Model are MIPS APMs for the 2017 performance period. For 
these two MIPS APMs, in accordance with our regulations at Sec.  
414.1370(h), the MIPS performance category scores are weighted as 
follows: Quality at 50 percent; cost at zero percent; improvement 
activities at 20 percent; and advancing care information at 30 percent 
of the final score. For all other MIPS APMs for the 2017 performance 
period, quality and cost are each weighted at zero percent, improvement 
activities at 25 percent, and advancing care information at 75 percent 
of the final score.
    In the CY 2018 Quality Payment Program proposed rule, for the APM 
scoring standard, we proposed to: Amend Sec.  414.1370(e) to add an APM 
Entity group assessment date for MIPS eligible clinicians in full TIN 
APMs; continue to weight the cost performance category at zero and, in 
alignment with that proposal, to not take improvement into account for 
the cost performance category for 2020 and subsequent years; add the 
CAHPS for ACOs survey to the list of Shared Savings Program and Next 
Generation ACO Model quality measures that are used to calculate the 
MIPS APM quality performance category score beginning with the 2018 
performance period; define ``Other MIPS APMs'' under Sec.  414.1305; 
establish a separate MIPS APM list of quality measures for each Other 
MIPS APM and use that list for scoring in the quality performance 
category; calculate the MIPS quality performance category score for 
Other MIPS APMs using the APM-specific quality measures and score only 
those measures that are tied to payment as described under the terms of 
the APM, are available for scoring near the close of the MIPS 
submission period, have a minimum of 20 cases available for reporting 
and have an available benchmark; and add scoring for quality 
improvement to the MIPS APM quality performance category for all MIPS 
APMs beginning in 2018. We also proposed a quality scoring methodology 
for Other MIPS APMs beginning in the 2018 MIPS performance period and 
described the scoring methodology for quality improvement for Other 
MIPS APMs. We proposed to align the MIPS performance category weights 
for Other MIPS APMs with those used for Web Interface reporter APMs 
under the APM scoring standard; and proposed policies to address 
situations where a MIPS eligible clinician qualifies for reweighting to 
zero percent in the advancing care information performance category. We 
also proposed, beginning with the 2018 performance period, to provide 
MIPS eligible clinicians scored using the APM scoring standard with 
performance feedback as specified under section 1848(q)(12) of the Act 
for the quality, advancing care information, and improvement activities 
performance categories to the extent data are available (82 FR 30080 
through 30091). We discuss these final policies in this section of this 
final rule with comment period.
    In reviewing these proposals, we reminded readers that the APM 
scoring standard is built upon regular MIPS but provides for special 
policies to address the unique circumstances of MIPS eligible 
clinicians who are in APM Entities participating in MIPS APMs. For the 
cost, improvement activities, and advancing care information 
performance categories, unless a separate policy has been established 
or is being proposed for the APM scoring standard, the generally 
applicable MIPS policies would be applicable to the APM scoring 
standard. Additionally, unless we included a proposal to adopt a unique 
policy for the APM scoring standard, we proposed to adopt the same 
generally applicable MIPS policies proposed elsewhere in the CY 2018 
Quality Payment Program proposed rule and would treat the APM Entity 
group as the group for purposes of MIPS. For the quality performance 
category, however, the APM scoring standard we proposed is presented as 
a separate, unique standard, and therefore, generally applicable MIPS 
policies would not be applied to the quality performance category under 
the APM scoring standard unless specifically stated. We sought comment 
on whether there may be potential conflicts or inconsistencies between 
the generally applicable MIPS policies and those proposed under the APM 
scoring standard, particularly where these could impact our goals to 
reduce duplicative and potentially incongruous reporting requirements 
and performance evaluations that could undermine our ability to test or 
evaluate MIPS APMs, or whether certain generally applicable MIPS 
policies should be made explicitly applicable to the APM scoring 
standard.
(2) Assessment Dates for Inclusion of MIPS Eligible Clinicians in APM 
Entity Groups Under the APM Scoring Standard
    In the CY 2017 Quality Payment Program final rule, we specified in 
our regulations at Sec.  414.1370(e) that the APM Entity group for 
purposes of scoring under the APM scoring standard is determined in the 
manner prescribed at Sec.  414.1425(b)(1), which provides that eligible 
clinicians who are on a Participation List on at least one of three 
dates (March 31, June 30, and August 31) would be considered part of 
the APM Entity group. Under these regulations, MIPS eligible clinicians 
who are not on a Participation List on one of these three assessment 
dates are not scored under the APM scoring standard. Instead, they 
would need to submit data to MIPS through one of the MIPS data 
submission mechanisms and their performance would be assessed either as 
individual MIPS eligible clinicians or as a group according to the 
generally applicable MIPS criteria.
    We stated that we will continue to use the three assessment dates 
of March 31, June 30, and August 31 to identify MIPS eligible 
clinicians who are on an APM Entity's Participation List and determine 
the APM Entity group that is used for purposes of the APM scoring 
standard (82 FR 30081). In addition, beginning in the 2018 performance 
period, we proposed to add a fourth assessment date of December 31 to 
identify those MIPS eligible clinicians who participate in a full TIN 
APM. We proposed to define full TIN APM at Sec.  414.1305 to mean an 
APM where participation is determined at the TIN level, and all 
eligible clinicians who have assigned their billing rights to a 
participating TIN are therefore participating in the APM. An example of 
a full TIN APM is the Shared Savings Program, which requires all 
individuals and entities that have reassigned their right to receive 
Medicare payment to the TIN of an ACO participant to participate in the 
ACO and comply with the requirements of the Shared Savings Program.
    If an eligible clinician elects to reassign their billing rights to 
a TIN participating in a full TIN APM, the eligible clinician is 
necessarily participating in the full TIN APM. We proposed to add this 
fourth date of December 31 only for MIPS eligible clinicians in a full 
TIN APM, and only for purposes of applying the APM scoring standard. We 
did not propose to use this additional assessment date of December 31 
for purposes of QP

[[Page 53690]]

determinations. Therefore, we proposed to amend Sec.  414.1370(e) to 
identify the four assessment dates that would be used to identify the 
APM Entity group for purposes of the APM scoring standard, and to 
specify that the December 31 date would be used only to identify MIPS 
eligible clinicians on the APM Entity's Participation List for a MIPS 
APM that is a full TIN APM in order to add them to the APM Entity group 
that is scored under the APM scoring standard.
    We proposed to use this fourth assessment date of December 31 to 
extend the APM scoring standard to only those MIPS eligible clinicians 
participating in MIPS APMs that are full TIN APMs, ensuring that a MIPS 
eligible clinician who joins the full TIN APM between August 31 and 
December 31 in the performance period would be scored under the APM 
scoring standard. We considered proposing to use the fourth assessment 
date more broadly for all MIPS APMs. However, we noted that we believe 
that approach would have allowed MIPS eligible clinicians to 
inappropriately leverage the fourth assessment date to avoid reporting 
and scoring under the generally applicable MIPS scoring standard when 
they were part of the MIPS APM for only a very limited portion of the 
performance period. That is, for MIPS APMs that allow split TIN 
participation, we were concerned that it would be possible for MIPS 
eligible clinicians to briefly join a MIPS APM principally in order to 
benefit from the APM scoring standard, despite having limited 
opportunity to contribute to the APM Entity's performance in the MIPS 
APM. In contrast, we believe MIPS eligible clinicians would be less 
likely to join a full TIN APM principally to avail themselves of the 
APM scoring standard, since doing so would require either that the 
entire TIN join the MIPS APM or the administratively burdensome act of 
the MIPS eligible clinician reassigning their billing rights to the TIN 
of an entity participating in the full TIN APM.
    We will continue to use only the three dates of March 31, June 30, 
and August 31 to determine, based on Participation Lists, the MIPS 
eligible clinicians who participate in MIPS APMs that are not full TIN 
APMs. We sought comment on the proposed addition of the fourth date of 
December 31 to assess Participation Lists to identify MIPS eligible 
clinicians who participate in MIPS APMs that are full TIN APMs for 
purposes of the APM scoring standard.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: CMS received many comments in support of our proposal to 
add the December 31 snapshot date for full TIN APMs.
    Response: We thank commenters for their support of our proposal.
    Comment: Several commenters recommended that CMS make the fourth 
snapshot date policy retroactive so that it would apply for the 2017 
performance period.
    Response: We understand commenters' desire for the proposed policy 
to be applied retroactively to the 2017 performance period. However, in 
consideration of the requirement that we give the public notice of 
proposed changes and an opportunity to comment on them, we refrain from 
making retroactive regulatory changes unless there is specific and 
articulable authority and a reason why it is necessary and appropriate 
to do so; and we do not believe we have those in this situation.
    Comment: A few commenters requested a switch to 90 day assessment 
periods to determine participation in MIPS APMs.
    Response: We believe it is simplest to generally align the snapshot 
dates used for purposes of the APM scoring standard for MIPS APMs with 
those used to identify eligible clinicians in Advanced APMs for 
purposes of QP determinations.
    We anticipate that the current snapshot policy will identify the 
vast majority of MIPS eligible clinicians in MIPS APMs at the first 
snapshot, and then at subsequent snapshot dates will add those MIPS 
eligible clinicians who join a MIPS APM later in the year but still 
have a significant opportunity to contribute to the APM Entity's 
performance in the MIPS APM. As such, we believe this policy would more 
appropriately identify MIPS eligible clinicians for purposes of 
applying the APM scoring standard.
    Comment: A few commenters suggested adding the fourth snapshot date 
of December 31 for QP determinations as well.
    Response: We reiterate that we did not propose to add a fourth 
snapshot date of December 31 for QP determinations and we will not 
adopt a policy to do so in this rulemaking. We believe that the 
snapshot policy that we finalized in the CY 2017 Quality Payment 
Program final rule will allow for us to make QP determinations such 
that eligible clinicians, including those who fail to become QPs and 
who may need to report to MIPS, would know their QP status in advance 
of the end of the MIPS reporting period.
    Comment: A few commenters requested that CMS provide more 
information as to whether an eligible clinician is counted as a 
participant in a MIPS APM so that they know whether or not they are 
required to report to MIPS.
    Response: In the CY 2017 Quality Payment Program final rule, we 
stated that it is important to ensure that the appropriate parties are 
properly notified of their status for purposes of MIPS. We also stated 
that we would provide additional information on the format of such 
notifications and the data we will include as part of our public 
communications following the issuance of that final rule (81 FR 77450).
    Comment: Numerous comments recommended that CMS extend the fourth 
snapshot date to all MIPS APM participants.
    Response: In addition to avoiding duplicative or potentially 
inconsistent reporting requirements or incentives between MIPS and a 
MIPS APM, the APM scoring standard is intended to reduce the reporting 
burden of participants in MIPS APMs who have focused their practice 
transformation activities in the preceding performance period on the 
requirements of participation in the APM. As such, we believe it is 
appropriate to ensure that the APM scoring standard applies only for 
those who are genuinely committed to participation in MIPS APMs. By 
limiting applicability of the APM scoring standard to eligible 
clinicians who are on a MIPS APM's Participation List on one of the 
first three snapshot dates, we hope to minimize any potential 
opportunity for certain MIPS eligible clinicians to take inappropriate 
advantage of the APM scoring standard. Full TIN APMs, however, require 
that all individuals and entities billing through a TIN agree to 
participate in the APM in which the TIN is a participant. As a result, 
to avail themselves of the APM scoring standard, clinicians or entities 
would have to undergo the additional burden of joining a different 
billing TIN before starting their participation in the APM. Therefore, 
we believe that the risk of a MIPS eligible clinician inappropriately 
leveraging the APM scoring standard by joining an APM late in the year 
is significantly diminished in full-TIN APMs, and we are comfortable 
allowing for the use of the fourth snapshot date at the end of the 
performance period to identify the eligible clinicians participating in 
these APMs. We will continue to monitor this issue and may consider in 
future rulemaking whether there are other APM designs for which using a 
fourth

[[Page 53691]]

snapshot date would also be appropriate.
    Final Action: After considering public comments, we are finalizing 
our proposal to define full TIN APM at Sec.  414.1305 to mean an APM 
where participation is determined at the TIN level, and all eligible 
clinicians who have assigned their billing rights to a participating 
TIN are therefore participating in the APM. We are also finalizing our 
proposal to add a fourth date of December 31 only for MIPS eligible 
clinicians in a full TIN APM only for purposes of applying the APM 
scoring standard and we are finalizing our proposal to amend Sec.  
414.1370(e) to identify the four assessment dates that would be used to 
identify the APM Entity group for purposes of the APM scoring standard. 
We are also finalizing our proposal to specify that the December 31 
date would be used only to identify MIPS eligible clinicians on the APM 
Entity's Participation List for a MIPS APM that is a full TIN APM in 
order to add them to the APM Entity group that is scored under the APM 
scoring standard.
(3) Calculating MIPS APM Performance Category Scores
    In the CY 2017 Quality Payment Program final rule, we established a 
scoring standard for MIPS eligible clinicians participating in MIPS 
APMs to reduce participant reporting burden by reducing the need for 
MIPS eligible clinicians participating in these types of APMs to make 
duplicative data submissions for both MIPS and their respective APMs 
(81 FR 77246 through 77271). In accordance with section 
1848(q)(1)(D)(i) of the Act, we finalized a policy under which we 
assess the performance of a group of MIPS eligible clinicians in an APM 
Entity that participates in one or more MIPS APMs based on their 
collective performance as an APM Entity group, as defined in 
regulations at Sec.  414.1305.
    In addition to reducing reporting burden, we sought to ensure that 
MIPS eligible clinicians in MIPS APMs are not assessed in multiple ways 
on the same performance activities. Depending on the terms of the 
particular MIPS APM, we believe that misalignments could be common 
between the evaluation of performance on quality and cost under MIPS 
versus under the terms of the APM. We continue to believe that 
requiring MIPS eligible clinicians in MIPS APMs to submit data, be 
scored on measures, and be subject to payment adjustments that are not 
aligned between MIPS and a MIPS APM could potentially undermine the 
validity of testing or performance evaluation under the APM. We also 
believe imposition of MIPS reporting requirements would result in 
reporting activity that provides little or no added value to the 
assessment of MIPS eligible clinicians, and could confuse these 
eligible clinicians as to which CMS incentives should take priority 
over others in designing and implementing care improvement activities.
(a) Cost Performance Category
    In the CY 2017 Quality Payment Program final rule, for MIPS 
eligible clinicians participating in MIPS APMs, we used our authority 
to waive certain requirements under the statute to reduce the scoring 
weight for the cost performance category to zero (81 FR 77258, 77262, 
and 77266). For MIPS APMs authorized under section 1115A of the Act 
using our authority under section 1115A(d)(1) of the Act, we waived the 
requirement under section 1848(q)(5)(E)(i)(II) of the Act, which 
specifies the scoring weight for the cost performance category. Having 
reduced the cost performance category weight to zero, we further used 
our authority under section 1115A(d)(1) of the Act to waive the 
requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of 
the Act to specify and use, respectively, cost measures in calculating 
the MIPS final score for MIPS eligible clinicians participating in MIPS 
APMs (81 FR 77261-77262; 81 FR 77265 through 77266). Similarly, for 
MIPS eligible clinicians participating in the Shared Savings Program, 
we used our authority under section 1899(f) of the Act to waive the 
same requirements of section 1848 of the Act for the MIPS cost 
performance category (81 FR 77257 through 77258). We finalized this 
policy because: (1) APM Entity groups are already subject to cost and 
utilization performance assessment under the MIPS APMs; (2) MIPS APMs 
usually measure cost in terms of total cost of care, which is a broader 
accountability standard that inherently encompasses the purpose of the 
claims-based measures that have relatively narrow clinical scopes, and 
MIPS APMs that do not measure cost in terms of total cost of care may 
depart entirely from MIPS measures; and (3) the beneficiary attribution 
methodologies differ for measuring cost under APMs and MIPS, leading to 
an unpredictable degree of overlap (for eligible clinicians and for 
CMS) between the sets of beneficiaries for which eligible clinicians 
would be responsible that would vary based on the unique APM Entity 
characteristics such as which and how many eligible clinicians comprise 
an APM Entity group. We believe that with an APM Entity's finite 
resources for engaging in efforts to improve quality and lower costs 
for a specified beneficiary population, measurement of the population 
identified through the APM must take priority in order to ensure that 
the goals and the model evaluation associated with the APM are as clear 
and free of confounding factors as possible. The potential for 
different, conflicting results across APMs and MIPS assessments may 
create uncertainty for MIPS eligible clinicians who are attempting to 
strategically transform their respective practices and succeed under 
the terms of the APM.
    We sought comment on our proposal to continue to waive the 
weighting of the cost performance category for the 2020 payment year 
forward (82 FR 30082). The following is a summary of the public 
comments we received on this proposal and our responses:
    Comment: Several commenters supported our proposal.
    Response: We thank commenters for their support of our proposal.
    Comment: One commenter requested that the cost performance category 
be scored for MIPS APMs to further incentivize efficient and 
appropriate care delivery.
    Response: We agree that encouraging efficient and appropriate care 
delivery is an important aim of MIPS. We also believe that the MIPS 
APMs specifically are working toward achieving this goal in diverse and 
innovative ways by basing participants' Medicare payment on their 
performance on cost/utilization and quality measures. Because 
participants in MIPS APMs are already scored and have payment based on 
their performance on cost/utilization measures under their respective 
APM, we continue to believe scoring of the cost performance category is 
unnecessary and could create conflicting incentives for participants in 
MIPS APMs if their MIPS payment adjustment is also based in part on 
their performance in the MIPS cost performance category.
    Comment: One commenter supported the reweighting of the cost 
performance category to zero, but requested that CMS provide 
performance feedback in the cost performance category to MIPS eligible 
clinicians in MIPS APMs.
    Response: We understand commenters' desire to have information on 
MIPS eligible clinicians' performance under the MIPS cost performance 
category, even if they are not scored on cost under the APM scoring 
standard. However, each MIPS APM's payment design is unique and 
distinct from MIPS. Comparing participants in these APMs to other

[[Page 53692]]

MIPS eligible clinicians may lead to misleading or not meaningful 
results. Because we are unable to provide accurate and meaningful 
feedback for the MIPS cost performance category for those MIPS eligible 
clinicians scored under the APM scoring standard, we will not be 
including it in the performance feedback. However, MIPS APMs may 
provide some level of feedback to their participants on cost/
utilization measure performance.
    Comment: One commenter suggested that CMS should score the cost 
performance category for MIPS APMs, but that CMS should first find a 
way to align episodes between MIPS and episode-based APMs.
    Response: Currently there is no way for us to align MIPS cost 
measures with episodes as defined within certain MIPS APMs because each 
of those MIPS APMs uniquely identifies the period of time over which 
performance is assessed and scored. For example, the Oncology Care 
Model has semi-annual performance periods, with 6-month episodes 
beginning on any day within a semi-annual performance period; initial 
reconciliation occurs after a performance period ends using a two month 
claims runout from the final day of the performance period, and 
subsequent ``true-up'' reconciliations capture additional claims runout 
after 8 and 14 months after the performance period ends. This MIPS APM 
uses unique methods of defining when performance is measured and scores 
calculated; attempting to align a model like the Oncology Care Model 
with other MIPS APMs or MIPS would require large-scale modifications to 
one or more initiatives that would undermine their design. Further, 
changing a MIPS APM's performance period could be burdensome and 
disruptive for health care providers participating in MIPS APMs. For 
these reasons, we do not believe it is advisable to change an APMs' 
episode timing or performance periods for MIPS purposes.
    Because of the innovative and unique nature of each MIPS APM and 
the need to maintain flexibility in designing and implementing them, we 
do not believe it would be appropriate to attempt to conform 
programmatic elements of APMs to MIPS.
    Final Action: After considering public comments, we are finalizing 
the proposal to continue to use our authority under sections 
1115A(d)(1) and 1899(f) of the Act to waive the requirements of the 
statute to reweight the cost performance category to zero for MIPS APMs 
for the 2020 payment year and subsequent payment years as proposed. We 
are codifying this policy at Sec.  414.1370(g)(2).
(i) Measuring Improvement in the Cost Performance Category
    In setting performance standards with respect to measures and 
activities in each MIPS performance category, section 1848(q)(3)(B) of 
the Act requires us to consider historical performance standards, 
improvement, and the opportunity for continued improvement. Section 
1848(q)(5)(D)(i)(I) of the Act requires us to introduce the measurement 
of improvement into performance scores in the cost performance category 
for MIPS eligible clinicians for the 2020 MIPS Payment Year if data 
sufficient to measure improvement are available. Section 
1848(q)(5)(D)(i)(II) of the Act permits us to take into account 
improvement in the case of performance scores in other performance 
categories. Given that we have in effect waivers of the scoring weight 
for the cost performance category, and of the requirement to specify 
and use cost measures in calculating the MIPS final score for MIPS 
eligible clinicians participating in MIPS APMs, and for the same 
reasons that we initially waived those requirements, we proposed to use 
our authority under section 1115A(d)(1) of the Act for MIPS APMs 
authorized under section 1115A of the Act and under section 1899(f) of 
the Act for the Medicare Shared Savings Program to waive the 
requirement under section 1848(q)(5)(D)(i)(I) of the Act to take 
improvement into account for performance scores in the cost performance 
category beginning with the 2018 MIPS performance period (82 FR 30082).
    We sought comment on this proposal. The following is a summary of 
the public comments we received and our response:
    Comment: Several commenters supported CMS's proposal to waive cost 
improvement scoring as participants in MIPS APMs are already scored and 
reimbursed on their performance on cost/utilization measures under the 
terms of the MIPS APM
    Response: We thank the commenters for their support of our 
proposal.
    Final Action: After considering public comments, we are finalizing 
the policy to waive cost improvement scoring as proposed.
(b) Quality Performance Category
(i) Web Interface Reporters: Shared Savings Program and Next Generation 
ACO Model
(A) Quality Measures
    We finalized in the CY 2017 Quality Payment Program final rule that 
under the APM scoring standard, participants in the Shared Savings 
Program and Next Generation ACO Model would be assessed for the 
purposes of generating a MIPS APM quality performance category score 
based exclusively on quality measures submitted using the CMS Web 
Interface (81 FR 77256, 77261). We also recognized that ACOs in both 
the Shared Savings Program and Next Generation ACO Model are required 
to use the CMS Web Interface to submit data on quality measures, and 
that the measures they are required to report for 2017 were also MIPS 
measures for 2017. We finalized a policy to use quality measures and 
data submitted by the participant ACOs using the CMS Web Interface and 
MIPS benchmarks for these measures to score quality for MIPS eligible 
clinicians in these MIPS APMs at the APM Entity level (81 FR 77256, 
77261). For these MIPS APMs, which we refer to as CMS Web Interface 
reporters going forward, we established that quality performance data 
that are not submitted using the Web Interface, for example, the CAHPS 
for ACOs survey and claims-based measures, will not be included in the 
MIPS APM quality performance category score for 2017. We also 
established a policy, codified at Sec.  414.1370(f)(1), to allow Shared 
Savings Program participant TINs to report quality on behalf of the TIN 
in the event that the ACO Entity fails to report quality on behalf of 
the APM Entity group, and for purposes of scoring under the APM scoring 
standard to treat such participant TINs as unique APM Entities.
(aa) Addition of New Measures
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30082 
through 30083), we proposed to score the CAHPS for ACOs survey in 
addition to the CMS Web Interface measures that are used to calculate 
the MIPS APM quality performance category score for participants in the 
Shared Savings Program and Next Generation ACO Model, beginning in the 
2018 performance period. The CAHPS for ACOs survey is already required 
in the Shared Savings Program and Next Generation ACO Model, and 
including the CAHPS for ACOs survey would better align the measures on 
which

[[Page 53693]]

participants in these MIPS APMs are assessed under the APM scoring 
standard with the measures used to assess participants' quality 
performance under the APM.
    We did not initially propose to include the CAHPS for ACOs survey 
as part of the MIPS APM quality performance category scoring for the 
Shared Savings Program and Next Generation ACO Model because we 
believed that the CAHPS for ACOs survey would not be collected and 
scored in time to produce a MIPS quality performance category score. 
However, operational efficiencies have recently been introduced that 
have made it possible to score the CAHPS for ACOs survey on the same 
timeline as the CAHPS for MIPS survey. Under the proposal, the CAHPS 
for ACOs survey would be added to the total number of quality 
performance category measures available for scoring in these MIPS APMs.
    While the CAHPS for ACOs survey is new to the APM scoring standard, 
the CG-CAHPS survey upon which it is based is also the basis for the 
CAHPS for MIPS survey, which was included on the MIPS final list for 
the 2017 performance period. For further discussion of the CAHPS for 
ACOs survey, and the way it will be scored, we refer readers to section 
II.C.7.a.(2)(b) of this final rule with comment period, which describes 
the CAHPS for MIPS survey and the scoring method that will be used for 
MIPS and the APM scoring standard in the 2018 performance period.
    We noted that although each question in the CAHPS for ACOs survey 
can also be found in the CAHPS for MIPS survey, the CAHPS for ACOs 
survey will have one fewer survey question in the Summary Survey 
Measure entitled ``Between Visit Communication'', which has never been 
a scored measure in the CAHPS for ACOs survey used in the Shared 
Savings Program or Next Generation ACO Model, and which we believe to 
be inappropriate to score for MIPS, as it is not scored under the terms 
of the APM.

       Table 10--Web Interface Reporters: Shared Savings Program and Next Generation ACO Model New Measure
----------------------------------------------------------------------------------------------------------------
                                 NQF/quality        National
         Measure name             number (if        quality            Measure description       Primary measure
                                 applicable)    strategy domain                                      steward
----------------------------------------------------------------------------------------------------------------
CAHPS for ACOs...............  Not Applicable.  Patient/         Consumer Assessment of          Agency for
                                                 Caregiver        Healthcare Providers and        Healthcare
                                                 Experience.      Systems (CAHPS) surveys for     Research and
                                                                  Accountable Care                Quality
                                                                  Organizations (ACOs) in the     (AHRQ).
                                                                  Medicare Shared Savings
                                                                  Program and Next Generation
                                                                  ACO Model ask consumers about
                                                                  their experiences with health
                                                                  care. The CAHPS for ACOs
                                                                  survey is collected from a
                                                                  sample of beneficiaries who
                                                                  get the majority of their
                                                                  care from participants in the
                                                                  ACO, and the questions
                                                                  address care received from a
                                                                  named clinician within the
                                                                  ACO.
                                                                 Survey measures include:--
                                                                  Getting Timely Care,
                                                                  Appointments, and Information
                                                                    --How Well Your Providers
                                                                     Communicate.
                                                                    --Patients' Rating of
                                                                     Provider.
                                                                    --Access to Specialists....
                                                                    --Health Promotion and
                                                                     Education.
                                                                    --Shared Decision Making...
                                                                    --Health Status/Functional
                                                                     Status.
                                                                    --Stewardship of Patient
                                                                     Resources.
----------------------------------------------------------------------------------------------------------------

    We sought comment on this proposal. The following is a summary of 
the public comments we received and our responses:
    Comment: Several commenters supported the proposal.
    Response: We thank commenters for their support of our proposal.
    Comment: One commenter expressed confusion as to whether the CAHPS 
for ACOs survey would be required under the APM scoring standard, or 
whether it is an optional measure.
    Response: Under the APM scoring standard, it is our goal to score 
all measures required under the terms of the APM. As part of the 
quality performance requirements for the Shared Savings Program and the 
Next Generation ACO Model, all participating ACOs are already required 
to report all of the measures included in the CAHPS for ACOs survey. 
Because we are able to score the CAHPS for ACOs survey, and it is 
mandatory under these APMs, it will be scored under the APM scoring 
standard for participants in those APMs. Notwithstanding the fact that 
the CAHPS for ACOs survey is mandatory for Shared Savings Program and 
Next Generation ACO participants, we note that MIPS eligible clinicians 
participating in ACOs will nonetheless be eligible to receive bonus 
points for reporting this measure, which is classified as a high-
priority measure, beginning in 2018.
    Comment: Some commenters objected to the subjective nature of the 
CAHPS for ACOs survey and the difficulty in acting on responses to 
improve quality.
    Response: Under both the Shared Savings Program and Next Generation 
ACO Model, ACOs are required to report on all of the measures included 
in the CAHPS for ACOs survey, and the results of the survey are used to 
assess the quality performance of the ACO. Because the CAHPS for ACOs 
survey is required under the terms of those initiatives, we believe it 
is appropriate to use the CAHPS for ACOs survey for purposes of the APM 
scoring standard.
    Final Action: After considering public comments, we are finalizing 
the policy to score the CAHPS for ACOs survey in addition to the CMS 
Web Interface measures that are used to calculate the MIPS APM quality 
performance category score for participants in the Shared Savings 
Program and Next Generation ACO Model, beginning in the 2018 
performance period, as proposed, in accordance with Sec.  
414.1370(g)(1)(i)(A).
(B) Calculating Quality Scores
    We refer readers to section II.C.7.a.(2) of this final rule with 
comment period for a summary of our final policies related to 
calculating the MIPS quality performance category percent score for 
MIPS eligible clinicians, including APM Entity groups, reporting 
through the CMS Web Interface, and a discussion of our proposed and 
final changes to those policies for the 2018 performance period. The 
changes we are finalizing in section II.C.7.a.(2) of this final rule 
with comment period apply in the same

[[Page 53694]]

manner under the APM scoring standard for Web Interface reporters 
except as otherwise noted in this section of this final rule with 
comment period.
    However, we proposed not to subject Web Interface reporters to a 3 
point floor because we do not believe it is necessary to apply this 
transition year policy to MIPS eligible clinicians participating in 
previously established MIPS APMs (82 FR 30083). We sought comment on 
this proposal.
    Final Action: We received no public comments on this proposal. We 
are finalizing this policy as proposed at Sec.  414.1370(g)(1)(i)(A).
(C) Incentives To Report High Priority Measures
    In the CY 2017 Quality Payment Program final rule, we finalized 
that for CMS Web Interface reporters, we will apply bonus points based 
on the finalized set of measures reportable through the Web Interface 
(81 FR 77291 through 77294). We will assign two bonus points for 
reporting each outcome measure (after the first required outcome 
measure) and for each scored patient experience measure. We will also 
assign one bonus point for reporting each other high priority measure.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30083), 
we noted that in addition to the measures required by the APM to be 
submitted through the CMS Web Interface, APM Entities in the Medicare 
Shared Savings Program and Next Generation ACO Model must also report 
the CAHPS for ACOs survey, and we proposed that, beginning for the 2020 
payment year forward, participants in the APM Entities may receive 
bonus points under the APM scoring standard for submitting that 
measure. Participants in MIPS APMs, like all MIPS eligible clinicians, 
are also subject to the 10 percent cap on bonus points for reporting 
high priority measures. APM Entities reporting through the CMS Web 
Interface will only receive bonus points if they submit a high priority 
measure with a performance rate that is greater than zero, and provided 
that the measure meets the case minimum requirements.
    Final Action: We received no public comment on this proposal. We 
are finalizing this policy as proposed at Sec.  414.1370(g)(1)(i)(C).
(D) Scoring Quality Improvement
    Beginning in the 2018 performance period, section 
1848(q)(5)(D)(i)(I) of the Act requires us to score improvement for the 
MIPS quality performance category for MIPS eligible clinicians, 
including those participating in MIPS APMs, if data sufficient to 
measure quality improvement are available. We proposed to calculate the 
quality improvement score using the methodology described in the CY 
2018 Quality Payment Program proposed rule for scoring quality 
improvement for MIPS eligible clinicians submitting quality measures 
via the CMS Web Interface (82 FR 30113, 30116-30119) and finalized at 
II.C.7.a.(2). In the CY 2018 Quality Payment Program proposed rule, we 
stated that we believe aligning the scoring methodology used for all 
Web Interface submissions will minimize confusion among MIPS eligible 
clinicians receiving a MIPS score, including those participating in 
MIPS APMs (82 FR 30083).
    The following is a summary of the public comments we received on 
this proposal and our response:
    Comment: Several commenters expressed support for our proposal to 
make quality improvement points available beginning in the 2018 
performance period.
    Response: We thank commenters for their support of our quality 
improvement scoring proposal.
    Final Action: We are finalizing this policy as proposed at Sec.  
414.1370(g)(1)(i)(B).
(E) Total Quality Performance Category Score for Web Interface 
Reporters
    In the 2018 Quality Payment Program proposed rule (82 FR 30083 
through 30084), we proposed to calculate the total quality percent 
score for APM Entities in APMs that require Web Interface reporting 
according to the methodology for scoring MIPS eligible clinicians 
reporting on quality through the CMS Web Interface described in section 
II.C.7.a.(2) of this final rule with comment period.
    We sought comment on our proposed quality performance category 
scoring methodology for Web Interface reporters. The following is a 
summary of the public comments we received and our responses:
    Comment: One commenter expressed confusion as to how quality 
improvement scoring will be calculated at the APM Entity level for MIPS 
eligible clinicians in MIPS APMs.
    Response: APM Entity groups, like other MIPS groups, will receive 
quality improvement scores for any year following a year in which one 
or more members of the APM Entity group was subject to MIPS and 
received a quality score. If the APM Entity group existed in the 
previous performance period and received a quality score, we will use 
that score for the purpose of calculating quality improvement points. 
If the APM Entity group did not exist or receive a quality score but 
some of its participant TIN/NPIs received quality scores in the 
previous performance period, the mean of those scores would be applied 
to the APM Entity group for the purpose of calculating quality 
improvement points. If the APM Entity group did not exist or receive a 
quality score and none of its participant MIPS eligible clinicians 
received quality scores in the previous performance period, no quality 
improvement points will be awarded.
    Final Action: After considering the public comments, we are 
finalizing the policy for calculating the total quality performance 
category score for Web Interface reporters as proposed at Sec.  
414.1370(g)(1)(i)(C).
(ii) Other MIPS APMs
    In the CY 2018 Quality Payment Program proposed rule (82 FR 20084), 
we proposed to define the term Other MIPS APM at Sec.  414.1305 of our 
regulations as a MIPS APM that does not require reporting through the 
Web Interface. We proposed to add this definition as we believe it will 
be useful in discussing our policies for the APM scoring standard. For 
the 2018 MIPS performance period, Other MIPS APMs will include the 
Comprehensive ESRD Care Model, the Comprehensive Primary Care Plus 
Model (CPC+), and the Oncology Care Model.
    We sought comment on this proposal. The following is a summary of 
the public comments we received on this proposal and our responses:
    Comment: One commenter objected to the use of the term Other MIPS 
APM and found the distinction between MIPS APMs and Other MIPS APMs 
confusing.
    Response: We clarify that MIPS APMs are those APMs that meet the 
four criteria of: (1) The APM Entities participate in the APM under an 
agreement with CMS by law or regulation, (2) the APM requires that 
Entities include at least one MIPS eligible clinician on a 
Participation List, (3) the APM bases payment incentives on performance 
(either at the APM Entity or clinician level) on cost/utilization and 
quality measures, and (4) the APM is not either a new APM for which the 
first performance period begins after the first day of the MIPS 
performance period for the year or an APM in the final year of 
operation for which the APM scoring standard is impracticable. Web 
Interface reporters are a subset of MIPS APMs where the terms of the 
APM require participating APM Entities to report quality data using the 
Web Interface. Other MIPS APMs include all MIPS APMs that are

[[Page 53695]]

not Web Interface reporters and are also a subset of MIPS APMs.
    Comment: Some commenters expressed confusion as to how Other MIPS 
APM policies will impact Next Generation ACOs.
    Response: The APM scoring standard applies for MIPS eligible 
clinicians in MIPS APMs. In discussing policies for the APM scoring 
standard, we developed terminology to describe two subcategories of 
MIPS APMs: Web Interface reporters (currently the Shared Savings 
Program and Next Generation ACO Model), and Other MIPS APMs (all other 
MIPS APMs that are not Web Interface reporters). Policies for Other 
MIPS APMs will apply only to MIPS APMs that do not require reporting 
through the Web Interface. For the 2018 performance period, only the 
Shared Savings Program and Next Generation ACO Model are Web Interface 
reporter APMs and therefore are not Other MIPS APMs.
    Final Action: After considering public comments, we are finalizing 
the policy as proposed by defining the term Other MIPS APM at Sec.  
414.1305.
(A) Quality Measures
    In the CY 2017 Quality Payment Program final rule, we explained 
that current MIPS APMs have requirements regarding the number of 
quality measures and measure specifications as well as the measure 
reporting method(s) and frequency of reporting, and have an established 
mechanism for submission of these measures to us within the structure 
of the specific MIPS APM. We explained that operational considerations 
and constraints interfered with our ability to use the quality measure 
data from some MIPS APMs for the purpose of satisfying MIPS data 
submission requirements for the quality performance category for the 
first performance period. We concluded that there was insufficient time 
to adequately implement changes to the current MIPS APM quality measure 
data collection timelines and infrastructure in the first performance 
period to conduct a smooth hand-off to the MIPS system that would 
enable use of quality measure data from these MIPS APMs to satisfy the 
MIPS quality performance category requirements in the first MIPS 
performance period (81 FR 77264). Out of concern that subjecting MIPS 
eligible clinicians who participate in these MIPS APMs to multiple, 
potentially duplicative or inconsistent performance assessments could 
undermine the validity of testing or performance evaluation under the 
MIPS APMs; and that there was insufficient time to make adjustments in 
operationally complex systems and processes related to the alignment, 
submission and collection of APM quality measures for purposes of MIPS, 
we used our authority under section 1115A(d)(1) of the Act to waive 
certain requirements of section 1848(q) of the Act for APMs authorized 
under section 1115A of the Act.
    In the CY 2017 Quality Payment Program final rule, we finalized 
that for the first MIPS performance period only, for MIPS eligible 
clinicians participating in APM Entities in Other MIPS APMs, the weight 
for the quality performance category is zero (81 FR 77268). To avoid 
risking adverse operational or program evaluation consequences for MIPS 
APMs while we worked toward incorporating MIPS APM quality measures 
into scoring for future performance periods, we used the authority 
provided by section 1115A(d)(1) of the Act to waive the quality 
performance category weight required under section 1848(q)(5)(E)(i)(I) 
of the Act for Other MIPS APMs, all of which are currently authorized 
under section 1115A of the Act, and we indicated that with the 
reduction of the quality performance category weight to zero, it was 
unnecessary to establish for these MIPS APMs a final list of quality 
measures as required under section 1848(q)(2)(D) of the Act or to 
specify and use quality measures in determining the MIPS final score 
for these MIPS eligible clinicians. As such, we further waived the 
requirements under sections 1848(q)(2)(D), 1848(q)(2)(B)(i), and 
1848(q)(2)(A)(i) of the Act to establish a final list of quality 
measures (using certain criteria and processes); and to specify and 
use, respectively, quality measures in calculating the MIPS final score 
for the first MIPS performance period.
    In the CY 2017 Quality Payment Program final rule, we anticipated 
that beginning with the second MIPS performance period, the APM quality 
measure data submitted to us during the MIPS performance period would 
be used to derive a MIPS quality performance score for APM Entities in 
all MIPS APMs. We also anticipated that it may be necessary to propose 
policies and waivers of requirements of the statute, such as section 
1848(q)(2)(D) of the Act, to enable the use of non-MIPS quality 
measures in the quality performance category score. We anticipated that 
by the second MIPS performance period we would have had sufficient time 
to resolve operational constraints related to use of separate quality 
measure systems and to adjust quality measure data submission 
timelines. Accordingly, we stated our intention, in future rulemaking, 
to use our section 1115A(d)(1) waiver authority to establish that the 
quality measures and data that are used to evaluate performance for APM 
Entities in Other MIPS APMs would be used to calculate a MIPS quality 
performance score under the APM scoring standard.
    We have since designed the means to overcome the operational 
constraints that prevented us from scoring quality for these MIPS APMs 
under the APM scoring standard in the first MIPS performance period, 
and in the CY 2018 Quality Payment Program proposed rule we proposed to 
adopt quality measures for use under the APM scoring standard, and to 
begin collecting MIPS APM quality measure performance data to generate 
a MIPS quality performance category score for APM Entities 
participating in Other MIPS APMs beginning with the 2018 MIPS 
performance period.
    We sought comment on this proposal. The following is a summary of 
the public comments we received on this proposal and our responses:
    Comment: Some commenters expressed support for our proposal.
    Response: We thank commenters for their support of our proposal.
    Final Action: After considering public comments, we are finalizing 
our proposal to use quality measure performance data reported for 
purposes of the Other MIPS APM to generate a MIPS quality performance 
category score for APM Entities participating in Other MIPS APMs 
beginning with the 2018 MIPS performance period as proposed. We are 
codifying this policy at Sec.  414.1370(g)(1)(ii)(A).
(aa) APM Measures for MIPS
    In the CY 2017 Quality Payment Program final rule, we explained the 
concerns that led us to express our intent to use the quality measures 
and data that apply in MIPS APMs for purposes of the APM scoring 
standard, including concerns about the application of multiple, 
potentially duplicative or inconsistent performance assessments that 
could negatively impact our ability to evaluate MIPS APMs (81 FR 
77246). Additionally, the quality and cost/utilization measures that 
are used to calculate performance-based payments in MIPS APMs may vary 
from one MIPS APM to another. Factors such as the type and quantity of 
measures required, the MIPS APM's particular measure specifications, 
how frequently the measures must be reported, and the mechanisms used 
to collect or submit the measures all add to the diversity in the 
quality and cost/utilization measures used to evaluate performance 
among MIPS APMs. Given

[[Page 53696]]

these concerns and the differences between and among the quality 
measures used to evaluate performance within MIPS APMs as opposed to 
those used more generally under MIPS, in the CY 2018 Quality Payment 
Program proposed rule, we proposed to use our authority under section 
1115A(d)(1) of the Act to waive requirements under section 
1848(q)(2)(D) of the Act, which requires the Secretary to use certain 
criteria and processes to establish an annual MIPS final list of 
quality measures from which all MIPS eligible clinicians may choose 
measures for purposes of assessment, and instead to establish a MIPS 
APM quality measure list for purposes of the APM scoring standard (82 
FR 30084). The MIPS APM quality measure list would be adopted as the 
final list of MIPS quality measures under the APM scoring standard for 
Other MIPS APMs, and would reflect the quality measures that are used 
to evaluate performance on quality within each Other MIPS APM.
    The MIPS APM measure list we proposed in Table 13 of the CY 2018 
Quality Payment Program proposed rule would define distinct measure 
sets for participants in each MIPS APM for purposes of the APM scoring 
standard, based on the measures that are used by the APM, and for which 
data will be collected by the close of the MIPS submission period. The 
measure sets on the MIPS APM measure list would represent all possible 
measures which may contribute to an APM Entity's MIPS score for the 
MIPS quality performance category, and may include measures that are 
the same as or similar to those used by MIPS. However, measures may 
ultimately not be used for scoring if a measure's data becomes 
inappropriate or unavailable for scoring; for example, if a measure's 
clinical guidelines are changed or the measure is otherwise modified by 
the APM during the performance period, the data collected during that 
performance period would not be uniform, and as such may be rendered 
unusable for purposes of the APM scoring standard (82 FR 30091).
    We sought comment on this proposal. The following is a summary of 
comments we received on this proposal and our responses:
    Comment: Several commenters expressed support for the proposed 
requirements for APM quality measures under the APM scoring standard.
    Response: We thank commenters for their support for our proposal to 
use quality measures that are used within Other MIPS APMs for purposes 
of scoring under the APM scoring standard.
    Comment: One commenter voiced concern that CMS would add measures 
to the APM scoring standard measure set outside of notice-and-comment 
rulemaking in order to include all measures used by a MIPS APM.
    Response: We clarify that we will not be scoring performance for 
any measures not included on the MIPS APM quality measure list included 
in each year's proposed rule. Any measures that are added to an Other 
MIPS APM's measure set after the proposed rule has been published will 
not be scored under the APM scoring standard until they have been 
proposed and adopted through notice-and-comment rulemaking in the 
following year.
    Comment: One commenter expressed concern that the time it takes to 
develop and implement new measures upon which eligible clinicians are 
scored may cause delays in the adoption of new innovative technologies 
with value that cannot easily be captured by current measure types, 
particularly among MIPS APM participants.
    Response: We do not believe any policies under the APM scoring 
standard would diminish any existing incentives for the adoption of new 
technologies, or affect the flexibility for APMs to set their own 
incentives for the adoption of such technologies. Furthermore, we 
encourage the public to respond to our annual call for measures, as 
described at section II.C.6.c.(1) of this final rule with comment 
period, to help ensure that appropriate measures are quickly adopted by 
appropriate programs.
    Comment: Several commenters requested more information about the 
way measures and their benchmarks are decided on for purposes of APMs.
    Response: For questions about APM measures and their benchmarks, we 
refer readers to https://qpp.cms.gov/apms/overview or the CMS Measure 
Development Plan: Supporting the Transition to the Quality Payment 
Program 2017 Annual Report, which is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2017-CMS-MDP-Annual-Report.pdf. We 
did not address or propose to modify policies relating to the 
development and adoption of measures or benchmarks for purposes of 
individual MIPS APMs.
    Comment: One commenter requested that CMS provide more information 
about reporting requirements for quality measures under the APM scoring 
standard for Other MIPS APMs.
    Response: Under the APM scoring standard, APM Entities will not be 
required to do any additional reporting on quality measures beyond what 
they are already required to report as part of their participation in 
the MIPS APM. Therefore, whatever specific reporting mechanisms and 
measures are required by each MIPS APM will also be used for purposes 
of MIPS under the APM scoring standard.
    Final Action: After considering public comments, we are finalizing 
our proposal to establish a MIPS APM quality measure list for purposes 
of the APM scoring standard at Sec.  414.1370(g)(1)(ii)(A).
(B) Measure Requirements for Other MIPS APMs
    Because the quality measure sets for each Other MIPS APM are 
unique, in the CY 2018 Quality Payment Program proposed rule, we 
proposed to calculate the MIPS quality performance category score using 
Other MIPS APM-specific quality measures (82 FR 30085). For purposes of 
the APM scoring standard, we proposed to score only measures that: (1) 
Are tied to payment as described under the terms of the APM, (2) are 
available for scoring near the close of the MIPS submission period, (3) 
have a minimum of 20 cases available for reporting, and (4) have an 
available benchmark. We discuss our policies for each of these 
requirements for Other MIPS APM quality measures below.
    We sought comment on this proposal. The following is a summary of 
the comments we have received and our responses:
    Comment: Some commenters recommended that CMS exclude three 
additional categories from those that will be used for scoring under 
the APM scoring standard when including Other MIPS APM measures: pay-
for-reporting measures, utilization measures, and measures that are new 
within an APM.
    Response: We clarify that pay-for-reporting measures will not be 
scored because they do not have an available benchmark. As such, we do 
not believe it is necessary to explicitly state that we will exclude 
these measures. Measures that are new within an APM are often pay-for-
reporting in their first year in order to give time for APM 
participants to gain experience with the measure and to establish a 
benchmark; in cases where new measures are immediately pay for 
performance, we believe it would be appropriate to score them because 
the measures themselves would be used under the terms of the APM, and 
to the extent possible it is our goal to align scoring under the APM 
scoring standard with scoring under the terms of the APM. Tying payment 
to cost/utilization is a requirement of all MIPS APMs; cost/

[[Page 53697]]

utilization measures tied to payment are often used by the APMs to meet 
this requirement. Because we will not score MIPS APMs on cost, we 
believe that cost/utilization measures should be scored under the APM 
scoring standard as a means of incentivizing performance within MIPS 
APMs in this MIPS priority area.
    Comment: One commenter voiced concern that the new APM scoring 
standard requirements would be burdensome or confusing for APM Entities 
during the first performance period, and suggested that CMS should 
allow APM Entities to report according to general MIPS quality 
reporting requirements for the APM scoring standard.
    Response: We thank commenters for their concern; however, there 
will be no added reporting burden for participants in MIPS APMs because 
we will be using the quality measure performance data that the APM 
Entity is already submitting as part of the requirements for 
participation in the MIPS APM.
    Final Action: After considering public comments, we are finalizing 
as proposed the policy to only score measures that (1) are tied to 
payment as described under the terms of the APM, (2) are available for 
scoring near the close of the MIPS submission period, (3) have a 
minimum of 20 cases available for reporting, and (4) have an available 
benchmark at Sec.  414.1370(g)(1)(ii)(A)(1) through (4).
(aa) Tied to Payment
    As discussed in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30085), for purposes of the APM scoring standard, we proposed to 
consider a measure to be tied to payment if an APM Entity group will 
receive a payment adjustment or other incentive payment under the terms 
of the APM, based on the APM Entity's performance on the measure.
    We sought comment on this proposal. We did not receive any comments 
on this proposal.
    Final Action: We are finalizing the policy as proposed.
(bb) Available for Scoring
    Some MIPS APM quality measure results are not available until late 
in the calendar year subsequent to the MIPS performance period, which 
would prevent us from including them in the MIPS APM quality 
performance category score under the APM scoring standard due to the 
larger programmatic timelines for providing MIPS eligible clinician 
performance feedback by July and issuing budget-neutral MIPS payment 
adjustments. Consequently, we proposed to only use the MIPS APM quality 
measure data that are submitted by the close of the MIPS submission 
period and are available for scoring in time for inclusion to calculate 
a MIPS quality performance category score (82 FR 30085). Measures are 
to be submitted according to requirements under the terms of the APM; 
the measure data will then be aggregated and prepared for submission to 
MIPS for the purpose of creating a MIPS quality performance category 
score.
    We believe using the Other MIPS APMs' quality measure data that 
have been submitted no later than the close of the MIPS submission 
period and have been processed and made available to MIPS for scoring 
in time to calculate a MIPS quality performance category score is 
consistent with our intent to decrease duplicative reporting for MIPS 
eligible clinicians who would otherwise need to report quality measures 
to both MIPS and their APM. Going forward, these are the measures to 
which we are referring in our proposal to limit scoring to measures 
that are available near the close of the MIPS submission period.
    We sought comment on this proposal. We did not receive any comments 
on this proposal.
    Final Action: We are finalizing the policy as proposed.
(cc) 20 Case Minimum
    We also believe that a 20 case minimum, in alignment with the one 
finalized generally under MIPS in the CY 2017 Quality Payment Program 
final rule, is necessary to ensure the reliability of the measure data 
submitted, as we explained the CY 2017 Quality Payment Program final 
rule (81 FR 77288).
    We proposed that when an APM Entity reports a quality measure that 
includes less than 20 cases, under the APM scoring standard, the 
measure would receive a null score for that measure's achievement 
points, and the measure would be removed from both the numerator and 
the denominator of the MIPS quality performance category percentage. We 
proposed to apply this policy under the APM scoring standard.
    We sought comment on this proposal. The following is a summary of 
the comments we received on this proposal and our responses:
    Comment: One commenter expressed concern as to how failure to 
report the 20 case minimum would impact an APM Entity's score.
    Response: We reiterate that entities that do not reach the 20 case 
minimum for a particular measure will not be penalized for not 
reporting the measure, but instead will receive a null score for that 
particular measure, which will be removed from the numerator and 
denominator when calculating the total quality score, and will 
therefore have neither a positive nor negative impact on the APM 
Entity's overall quality performance category score.
    Final Action: After considering public comments, we are finalizing 
the proposal to establish a 20 case minimum for quality measures under 
the APM scoring standard without change.
(dd) Available Benchmark
    An APM Entity's achievement score on each quality measure would be 
calculated in part by comparing the APM Entity's performance on the 
measure with a benchmark performance score. Therefore, we would need 
all scored measures to have a benchmark available by the time that the 
MIPS quality performance category score is calculated in order to make 
that comparison.
    We proposed that, for the APM scoring standard, the benchmark score 
used for a quality measure would be the benchmark used in the MIPS APM 
for calculation of the performance based payments, where such a 
benchmark is available. If the MIPS APM does not produce a benchmark 
score for a reportable measure that is included on the MIPS APM 
measures list, we would use the benchmark score for the measure that is 
used for the MIPS quality performance category generally (outside of 
the APM scoring standard) for that MIPS performance period, provided 
the measure specifications for the measure are the same under both the 
MIPS final list and the APM measures list. If neither the APM nor MIPS 
has a benchmark available for a reported measure, the APM Entity that 
reported that measure would receive a null score for that measure's 
achievement points, and the measure would be removed from both the 
numerator and the denominator of the quality performance category 
percentage.
    We sought comment on this proposal. The following is a summary of 
the comments we received on this proposal and our responses:
    Comment: One commenter objected to CMS's proposal to remove 
measures from scoring for which no benchmark is available, and instead 
suggested that we assign three points for the measure in alignment with 
general MIPS policy.
    Response: We thank the commenter for the suggestion. In general, we 
have attempted to create consistency between the MIPS and the APM 
scoring standard when practicable. However, in this case doing so would 
be inappropriate

[[Page 53698]]

because APM participants are required to report on all APM measures 
used in the MIPS APM, whereas eligible clinicians reporting under 
general MIPS are given the opportunity to choose six of the measures 
from the MIPS measure set. We believe that it would be unfair to 
require APM Entities to report on measures for which they are unable to 
achieve a score above three, which could significantly impact their 
total quality performance category score. For example, if an APM 
requires that five measures be reported, and an APM Entity received 10 
points on 4 measures, but did not meet the 20 case minimum on the fifth 
measure, the formula for calculating the quality score would be [(10 + 
10 + 10 + 10)/4] = 10 (or, 100 percent), rather than [(10 + 10 + 10 + 
10 + 3)/5] = 8.6 (or, 86 percent).
    Comment: One commenter expressed concern that by limiting the use 
of measures to those for which a benchmark is available, CMS may be 
overly restrictive of new models in their first years of operation, and 
that CMS should instead use any measure for which a benchmark could be 
calculated based on the current performance year.
    Response: To score quality for Other MIPS APMs, we will use any 
available benchmark that is being used by the APM. In the event an APM 
does not have a benchmark for a given measure, we will use MIPS 
benchmarks for that measure if available. With this level of benchmark 
flexibility, we do not anticipate lack of benchmarks will eliminate a 
significant number of measures from the APM scoring standard quality 
calculations.
    Comment: Several commenters objected to scoring Web Interface 
reporters based on the same benchmarks and decile distribution as those 
in Other MIPS APMs reporting through other mechanisms.
    Response: Under the APM scoring standard, Web Interface reporters 
will be scored on a scale unique to Web Interface reporters and based 
on benchmarks generated through the Web Interface. Other MIPS APMs do 
not use the Web Interface and therefore measures will be scored under 
the APM scoring standard's Other MIPS APM scoring methodology using a 
decile distribution unique to each Other MIPS APM.
    Comment: One commenter objected to the use of MIPS measure 
benchmarks in the absence of APM measure benchmarks, despite the 
comparability of the measures, because the effect may be to compare the 
performance of a specific specialty against that of the general health 
care provider population.
    Response: While the use of MIPS benchmarks in the absence of an APM 
benchmark would mean comparing the performance of APM participants to 
the performance of the general MIPS population in order to create the 
measure score, for measures that are used by MIPS as well as MIPS APMs, 
there would not be an advantage or disadvantage given to APM 
participants relative to the general population of MIPS eligible 
clinicians and their scores would simply reflect how they would have 
performed under general MIPS scoring.
    Final Action: After considering public comments, we are finalizing 
the policy with respect to the use of quality performance benchmarks as 
proposed.
(C) Calculating the Quality Performance Category Percent Score
    Eligible clinicians who participate in Other MIPS APMs are subject 
to specific quality measure reporting requirements within these APMs. 
To best align with APM design and objectives, in the CY 2018 Quality 
Payment Program proposed rule, we proposed that the minimum number of 
required measures to be reported for the APM scoring standard would be 
the minimum number of quality measures that are required by the MIPS 
APM and are collected and available in time to be included in the 
calculation for the APM Entity score under the APM scoring standard. 
For example, if an Other MIPS APM requires participating APM Entities 
to report nine of 14 quality measures and the APM Entity fails to 
submit them by the APM's submission deadline, then for the purposes of 
calculating an APM Entity quality performance category score, the APM 
Entity would receive a zero for those measures. An APM Entity that does 
not submit any APM quality measures by the submission deadline would 
receive a zero for its MIPS APM quality performance category percent 
score for the MIPS performance period.
    We also proposed that if an APM Entity submits some, but not all of 
the measures required by the MIPS APM by the close of the MIPS 
submission period, the APM Entity would receive points for the measures 
that were submitted, but would receive a score of zero for each 
remaining measure between the number of measures reported and the 
number of measures required by the APM that were available for scoring.
    For example, if an APM Entity in the above hypothetical MIPS APM 
submits quality performance data on three of the APM's measures, 
instead of the required nine, the APM Entity would receive quality 
points in the APM scoring standard quality performance category percent 
score for the three measures it submitted, but would receive zero 
points for each of the six remaining measures that were required under 
the terms of the MIPS APM. On the other hand, if an APM Entity reports 
on more than the minimum number of measures required to be reported 
under the MIPS APM and the measures meet the other criteria for 
scoring, only the measures with the highest scores, up to the number of 
measures required to be reported under the MIPS APM, would be counted; 
however, any bonus points earned by reporting on measures beyond the 
minimum number of required measures would be awarded.
    If a measure is reported but fails to meet the 20 case minimum or 
does not have a benchmark available, there would be a null score for 
that measure, and it would be removed from both the numerator and the 
denominator, so as not to negatively affect the APM Entity's quality 
performance category score.
    We proposed to assign bonus points for reporting high priority 
measures or measures with end-to-end CEHRT reporting as described for 
general MIPS scoring in the CY 2017 Quality Payment Program final rule 
(81 FR 77297 through 77299).
    We sought comment on these proposals. The following is a summary of 
the public comments we received and our response:
    Comment: Some commenters recommended that CMS require APM Entities 
to report on the same number of measures required under regular MIPS: 
Six.
    Response: We thank commenters for this input. However, we note that 
under the APM scoring standard, eligible clinicians participating in 
MIPS APMs are not required to report any additional measures for 
purposes of MIPS scoring beyond those reported under their MIPS APM, 
and they will only be scored on the minimum number of measures required 
by the APM. The purpose of this policy is to help align incentives 
between the APMs and the Quality Payment Program, and not to emphasize 
performance in one over the other. Given this, it would not be 
appropriate to set a minimum number of measures independent of the 
requirements of the APM.
    Final Action: After considering public comments, we are finalizing 
the policy for calculating the quality performance category score as 
proposed at Sec.  414.1370(g)(1)(ii)(A).

[[Page 53699]]

(aa) Quality Measure Benchmarks
    An APM Entity's MIPS APM quality score will be calculated by 
comparing the APM Entity's performance on a given measure with a 
benchmark performance score. We proposed that the benchmark score used 
for a quality measure would be the benchmark used by the MIPS APM for 
calculation of the performance based payments within the APM, if 
possible, in order to best align the measure performance outcomes 
between MIPS APMs and MIPS generally. If the MIPS APM does not produce 
a benchmark score for a reportable measure that will be available at 
the close of the MIPS submission period, the benchmark score for the 
measure that is used for the MIPS quality performance category 
generally for that performance period would be used, provided the 
measure specifications are the same for both. If neither the APM nor 
MIPS has a benchmark available for a reported measure, the APM Entity 
that reported that measure will receive a null score for that measure's 
achievement points, and the measure will be removed from both the 
numerator and the denominator of the quality performance category 
percentage.
    We proposed that for measures that are pay-for-reporting or which 
do not measure performance on a continuum of performance, we will 
consider these measures to be lacking a benchmark and they will be 
treated as such. For example, if a MIPS APM only requires that an APM 
Entity must surpass a threshold and does not measure APM Entities on 
performance beyond surpassing a threshold, we would not consider such a 
measure to measure performance on a continuum.
    We proposed to score quality measure performance under the APM 
scoring standard using a percentile distribution, separated by decile 
categories, as described in the finalized MIPS quality scoring 
methodology (81 FR 77282 through 77284). For each benchmark, we will 
calculate the decile breaks for measure performance and assign points 
based on the benchmark decile range into which the APM Entity's measure 
performance falls.
    We proposed to use a graduated points-assignment approach, where a 
measure is assigned a continuum of points out to one decimal place, 
based on its place in the decile. For example, as shown in Table 11, a 
raw score of 55 percent would fall within the sixth decile of 41.0 
percent to 61.9 percent and would receive between 6.0 and 6.9 points.

                 Table 11--Benchmark Decile Distribution
------------------------------------------------------------------------
                                      Sample quality    Graduated points
      Sample benchmark decile       measure (percent)   (with no floor)
------------------------------------------------------------------------
Example Benchmark Decile 1........              0-9.9            1.0-1.9
Example Benchmark Decile 2........          10.0-17.9            2.0-2.9
Example Benchmark Decile 3........          18.0-22.9            3.0-3.9
Example Benchmark Decile 4........          23.0-35.9            4.0-4.9
Example Benchmark Decile 5........          36.0-40.9            5.0-5.9
Example Benchmark Decile 6........          41.0-61.9            6.0-6.9
Example Benchmark Decile 7........          62.0-68.9            7.0-7.9
Example Benchmark Decile 8........          69.0-78.9            8.0-8.9
Example Benchmark Decile 9........          79.0-84.9            9.0-9.9
Example Benchmark Decile 10.......           85.0-100               10.0
------------------------------------------------------------------------

    We sought comment on our proposal. The following is a summary of 
the public comments received on this proposal and our response:
    Comment: One commenter voiced concern that comparing performance of 
MIPS APM participants against the performance of eligible clinicians 
assessed under regular MIPS would skew benchmarks and give MIPS APM 
participants an unfair advantage in calculating a MIPS score.
    Response: In circumstances where an APM does not have a benchmark 
available for a measure, but a MIPS benchmark is available, we proposed 
to use the MIPS benchmark to create a measure score. These benchmark 
scores reflect performance of eligible clinicians in the MIPS program, 
against whom MIPS APM participants will ultimately be compared. As 
such, we do not believe the use of these benchmarks is inappropriate in 
this context.
    Final Action: After considering public comments, we are finalizing 
the policy for applying quality measure benchmarks to calculate an APM 
Entity's MIPS quality measure score as proposed.
(bb) Assigning Quality Measure Points Based on Achievement
    For the APM scoring standard quality performance category, we 
proposed that each APM Entity that reports on quality measures would 
receive between 1 and 10 achievement points for each measure reported 
that can be reliably scored against a benchmark, up to the number of 
measures that are required to be reported by the APM (82 FR 30086 
through 30087). Because measures that lack benchmarks or 20 reported 
cases are removed from the numerator and denominator of the quality 
performance category percentage, it is unnecessary to include a point-
floor for scoring of Other MIPS APMs. Similarly, because the quality 
measures reported by the MIPS APM for MIPS eligible clinicians under 
the APM scoring standard are required to be submitted to the APM under 
the terms of the APM, and the MIPS eligible clinicians do not select 
their APM measures, there will be no cap on topped out measures for 
MIPS APM participants being scored under the APM scoring standard, 
which differs from the policy for other MIPS eligible clinicians 
proposed in the CY 2018 Quality Payment Program proposed rule (82 FR 
30101 through 30103).
    Beginning in the 2018 MIPS performance period, we proposed that APM 
Entities in MIPS APMs, like other MIPS eligible clinicians, would be 
eligible to receive bonus points for the MIPS quality performance 
category for reporting on high priority measures or measures submitted 
via CEHRT (for example, end-to-end submission) (82 FR 30109). For each 
Other MIPS APM, we proposed to identify whether any of their available 
measures meets the criteria to receive a bonus, and add the bonus 
points to the quality achievement points. Further, we proposed that the 
total number of awarded bonus points may not exceed 10 percent of the 
APM Entity's total available achievement points for the MIPS quality 
performance category score.

[[Page 53700]]

    To generate the APM Entity's quality performance category 
percentage, achievement points would be added to any applicable bonus 
points, and then divided by the total number of available achievement 
points, with a cap of 100 percent. For more detail on the MIPS quality 
performance category percentage score calculation, we refer readers to 
section II.C.7.a.(2)(j) of this final rule with comment period.
    Under the APM scoring standard for Other MIPS APMs, the number of 
available achievement points would be the number of measures required 
under the terms of the APM and available for scoring multiplied by ten. 
If, however, an APM Entity reports on a required measure that fails the 
20 case minimum requirement, or for which there is no available 
benchmark for that performance period, the measure would receive a null 
score and all points from that measure would be removed from both the 
numerator and the denominator.
    For example, if an APM Entity reports on four out of four measures 
required to be reported by the MIPS APM, and receives an achievement 
score of five on each and no bonus points, the APM Entity's quality 
performance category percentage would be [(5 points x 4 measures) + 0 
bonus points]/(4 measures x 10 max available points), or 50 percent. 
If, however, one of those measures failed the 20 case minimum 
requirement or had no benchmark available, that measure would have a 
null value and would be removed from both the numerator and denominator 
to create a quality performance category percentage of [(5 points x 3 
measures) + 0 bonus points]/(3 measures x 10 max available points), or 
50 percent.
    If an APM Entity fails to meet the 20 case minimum on all available 
APM measures, that APM Entity would have its quality performance 
category score reweighted to zero, as described below.
    We sought comment on these proposals. The following is a summary of 
the public comments we received and our response:
    Comment: One commenter was concerned about the complexity of the 
program and suggested that the addition of additional scoring 
opportunities could become too burdensome for CMS to effectively 
administrate.
    Response: The APM scoring standard was designed to simplify 
administration of MIPS for both eligible clinicians in certain types of 
APMs and for CMS. We believe that we are prepared to effectively 
administer MIPS, including the APM scoring standard. However, as we 
gain additional experience in implementing MIPS, we will continue to 
monitor for opportunities to minimize complexity and reduce burden for 
all parties.
    Final Action: After considering public comments, we are finalizing 
the policy on assigning quality measure points for achievement as 
proposed.
(D) Quality Improvement Scoring
    Beginning in the 2018 MIPS performance period, we proposed to score 
improvement, as well as achievement in the quality performance category 
(82 FR 30087).
    For the APM scoring standard, we proposed that the quality 
improvement percentage points would be awarded based on the following 
formula:

Quality Improvement Score = (Absolute Improvement/Previous Year Quality 
Performance Category Percent Score Prior to Bonus Points)/10

    We sought comment on this proposal. The following is a summary of 
the public comments we received on this proposal and our responses:
    Comment: Several commenters expressed support for this proposal.
    Response: We thank commenters for their support for this proposal.
    Comment: One commenter suggested that rather than declining to 
score quality improvement for the MIPS eligible clinicians who had a 
quality performance category score of 0 in the previous performance 
year, or who did not participate in MIPS in the previous performance 
year, CMS should instead assign a minimum quality performance category 
score of 1 for purposes of calculating an improvement score.
    Response: We thank the commenter for the suggestion. While 
assigning a quality score of 1 in years in which no quality score is 
available would enable us to assign a quality improvement score, it 
would also have the effect of giving all first year participants higher 
quality improvement scores that do not necessarily reflect improvement. 
Instead, with this policy we seek to encourage early and consistent 
participation in MIPS by requiring two years of consecutive 
participation before the quality improvement score can be applied.
    We note that we inadvertently described the formula in error in the 
APM scoring standard section, but provided a cross-reference to the 
discussion and the correct formula under the general MIPS scoring 
standard (82 FR 30096). We are correcting the error in this final rule 
with comment period to clarify and resolve the inconsistency by 
changing the quality improvement score calculation to the following:

Quality Improvement Score = (Absolute Improvement/Previous Year Quality 
Performance Category Percent Score Prior to Bonus Points) * 10

    Final Action: After considering public comments, we are finalizing 
the proposed quality improvement score calculation with the corrected 
formula at Sec.  414.1370(g)(1)(ii)(B).
(E) Calculating Total Quality Performance Category Score
    We proposed that the APM Entity's total quality performance 
category score would be equal to [(achievement points + bonus points)/
total available achievement points] + quality improvement score. The 
APM Entity's total quality performance category score may not exceed 
100 percent. We sought comment on the proposed quality performance 
category scoring methodology for APM Entities participating in Other 
MIPS APMs. The following is a summary of the public comments we 
received on this proposal and our response:
    Comment: Several commenters expressed support for this proposed 
methodology.
    Response: We thank commenters for their support of this proposal.
    Final Action: After considering public comments, we are finalizing 
the policy for calculating the total quality performance category score 
as proposed at Sec.  414.1370(g)(1)(ii)(C).
(c) Improvement Activities Performance Category
    As we finalized in the CY 2017 Quality Payment Program final rule, 
for all MIPS APMs we will assign the same improvement activities score 
to each APM Entity based on the activities involved in participation in 
a MIPS APM (81 FR 77262 through 77266). As described in the CY 2017 
Quality Payment Program final rule, APM Entities will receive a minimum 
of one half of the total possible points (81 FR 77254). This policy is 
in accordance with section 1848(q)(5)(C)(ii) of the Act. In the event 
that the assigned score does not represent the maximum improvement 
activities score, the APM Entity group will have the opportunity to 
report additional improvement activities to add points to the APM 
Entity level score as described in section II.C.6.e. of this final rule 
with comment period We note that in the 2017 performance year, we 
determined that the improvement activities involved in participation in 
all MIPS APMs satisfied the requirements for participating APM entities 
to receive the maximum score of 100 percent in this performance 
category. In the 2018 Quality Payment

[[Page 53701]]

Program proposed rule, we did not propose any changes to this policy 
for the 2018 MIPS performance period (82 FR 30087). We have made some 
clarifying edits to Sec.  414.1370(g)(3)(i).

(d) Advancing Care Information Performance Category

    In the CY 2017 Quality Payment Program final rule, we finalized our 
policy to attribute one score to each MIPS eligible clinician in an APM 
Entity group by looking for both individual and group TIN level data 
submitted for a MIPS eligible clinician and using the highest available 
score (81 FR 77268). We will then use these scores to create an APM 
Entity's score based on the average of the highest scores available for 
all MIPS eligible clinicians in the APM Entity group. If an individual 
or TIN did not report on the advancing care information performance 
category, the individual or TIN will contribute a zero to the APM 
Entity's aggregate score. Each MIPS eligible clinician in an APM Entity 
group will receive one score, weighted equally with the scores of every 
other MIPS eligible clinician in the APM Entity group, and we will use 
these scores to calculate a single APM Entity-level advancing care 
information performance category score.
(i) Special Circumstances
    As we explained in the CY 2017 Quality Payment Program final rule, 
under generally applicable MIPS scoring policy, we will assign a weight 
of zero percent to the advancing care information performance category 
in the final score for MIPS eligible clinicians who meet specific 
criteria: Hospital-based MIPS eligible clinicians, MIPS eligible 
clinicians who are facing a significant hardship, and certain types of 
non-physician practitioners (NPs, PAs, CRNAs, CNSs) who are MIPS 
eligible clinicians (81 FR 77238 through 77245). In the CY 2018 Quality 
Payment Program proposed rule, we proposed to include in this weighting 
policy ASC-based MIPS eligible clinicians and MIPS eligible clinicians 
who are using decertified EHR technology (82 FR 30077 through 30078).
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that under the APM scoring standard, if a MIPS eligible clinician who 
qualifies for a zero percent weighting of the advancing care 
information performance category in the final score is part of a TIN 
reporting at the group level that includes one or more MIPS eligible 
clinicians who do not qualify for a zero percent weighting, we would 
not apply the zero percent weighting to the qualifying MIPS eligible 
clinician, and the TIN would still report on behalf of the entire 
group, although the TIN would not need to report data for the 
qualifying MIPS eligible clinician. All MIPS eligible clinicians in the 
TIN who are participants in the MIPS APM would count towards the TIN's 
weight when calculating an aggregated APM Entity score for the 
advancing care information performance category.
    If, however, the MIPS eligible clinician is a solo practitioner and 
qualifies for a zero percent weighting, or if all MIPS eligible 
clinicians in a TIN qualify for the zero percent weighting, the TIN 
would not be required to report on the advancing care information 
performance category, and if the TIN chooses not to report that TIN 
would be assigned a weight of 0 when calculating the APM Entity's 
advancing care information performance category score.
    If advancing care information data are reported by one or more TIN/
NPIs in an APM Entity, an advancing care information performance 
category score will be calculated for, and will be applicable to, all 
MIPS eligible clinicians in the APM Entity group. If all MIPS eligible 
clinicians in all TINs in an APM Entity group qualify for a zero 
percent weighting of the advancing care information performance 
category, or in the case of a solo practitioner who comprises an entire 
APM Entity and qualifies for zero percent weighting, the advancing care 
information performance category would be weighted at zero percent of 
the final score, and the advancing care information performance 
category's weight would be redistributed to the quality performance 
category.
    We sought comment on this proposal. The following is a summary of 
the public comments we received and our responses:
    Comment: Some commenters supported the proposed policy to allow 
participants in MIPS APMs to also apply for advancing care information 
hardship exceptions like eligible clinicians participating under 
regular MIPS rules.
    Response: We thank commenters for their support for this policy.
    Comment: A few commenters suggested that the advancing care 
information hardship exception policy for all MIPS APMs should be 
uniform and that MIPS eligible clinicians who qualify for an exception, 
and who bill through the TIN of an ACO participant in a Shared Savings 
Program ACO should not be counted when weighting the TIN for purposes 
of calculating the APM Entity advancing care information performance 
category score. Some commenters also expressed confusion as to how TIN-
level advancing care information data are to be reported for the Shared 
Savings Program if a MIPS eligible clinician in an ACO participant TIN 
receives an exception or joins the TIN at various times in the year.
    Response: We thank commenters for bringing our attention to this 
issue. We proposed that under the APM scoring standard, if a MIPS 
eligible clinician is a solo practitioner and qualifies for a zero 
percent weighting in the advancing care information performance 
category, or if all MIPS eligible clinicians in a TIN qualify for the 
zero percent weighting, the TIN would not be required to report on the 
advancing care information performance category, and if the TIN chooses 
not to report that TIN would be assigned a weight of 0 when calculating 
the APM Entity's advancing care information performance category score. 
If the MIPS eligible clinician would have reported the advancing care 
information performance category as an individual and therefore 
contributed to the APM Entity's advancing care information score at the 
individual level but qualifies for a zero percent weighting of the 
advancing care information performance category, the individual will be 
removed from the numerator and denominator when calculating the APM 
Entity's advancing care information performance category score, thereby 
contributing a null value. If a MIPS eligible clinician qualifies for a 
zero percent weighting of the advancing care information performance 
category as described in II.C.6.f.(6) of this final rule with comment 
period as an individual, but receives an advancing care information 
score as part of a group, we will use that group score for that 
eligible clinician when calculating the APM Entity's advancing care 
information performance category score. We note that group level 
advancing care information reporting is not negatively affected by the 
failure of a single individual to report because it is based only on 
average reported performance within the group, not the average reported 
performance of all eligible clinicians in the group--those who do not 
report are not factored into the denominator. If, however, all MIPS 
eligible clinicians in a TIN qualify for a zero percent weighting of 
the advancing care information performance category, the entire TIN 
will be removed from the numerator and denominator, and therefore 
contribute a null value when calculating the APM Entity score. If all 
participant NPIs and TINs in an APM Entity are qualify for a zero 
percent weighting of the advancing care

[[Page 53702]]

information performance category and do not report, we will reweight 
the entire advancing care information performance category to zero 
percent of the final score for the APM Entity as described in Table 13.
    Final Action: After considering public comments, we are finalizing 
the policy for scoring the advancing care information performance 
category under the APM scoring standard as proposed at Sec.  
414.1370(g)(4)(iii).
(4) Calculating Total APM Entity Score
(a) Performance Category Weighting
    In the 2018 Quality Payment Program proposed rule, we proposed to 
continue to use our authority to waive sections 1848(q)(2)(B)(ii) and 
1848(q)(2)(A)(ii) of the Act to specify and use, respectively, cost 
measures, and to maintain the cost performance category weight of zero 
under the APM scoring standard for the 2018 performance period and 
subsequent MIPS performance periods (82 FR 30082). Because the cost 
performance category would be reweighted to zero, that weight would 
need to be redistributed to other performance categories. We proposed 
to use our authority under section 1115A(d)(1) to waive requirements 
under sections 1848(q)(5)(E)(i)(I)(bb), 1848(q)(5)(E)(i)(III) and 
1848(q)(5)(E)(i)(IV) of the Act that prescribe the weights, 
respectively, for the quality, improvement activities, and advancing 
care information performance categories (82 FR 30088). We proposed to 
weight the quality performance category score to 50 percent, the 
improvement activities performance category to 20 percent, and the 
advancing care information performance category to 30 percent of the 
final score for all APM Entities in Other MIPS APMs. We proposed these 
weights to align the Other MIPS APM performance category weights with 
those assigned to the Web Interface reporters, which we adopted as 
explained in the CY 2017 Quality Payment Program final rule (81 FR 
77262-77263). We believe it is appropriate to align the performance 
category weights for APM Entities in MIPS APMs that require reporting 
through the Web Interface with those in Other MIPS APMs. By aligning 
the performance category weights among all MIPS APMs, we would create 
greater scoring parity among the MIPS eligible clinicians in MIPS APMs 
who are being scored under the APM scoring standard.
    We sought comment on this proposal. The following is a summary of 
the comments and our responses:
    Comment: Some commenters supported CMS's proposal to weight the 
quality performance category to better align the APM scoring standard 
with regular MIPS scoring.
    Response: We thank commenters for their support of our proposal.
    Comment: Several commenters suggested delaying assigning a weight 
to the quality performance category until MIPS eligible clinicians and 
participants in APMs have had time to adjust to using these measures, 
as well as to ensure that the measures have been fully vetted.
    Response: We appreciate commenters' concerns that it may take time 
for MIPS eligible clinicians to adjust to this new program. However, we 
will be entering our second year of the Quality Payment Program in 2018 
after a transition year in which quality was not scored for Other MIPS 
APMs. Furthermore, while we acknowledge that the Quality Payment 
Program is still relatively new program, APM participants are already 
required to report the relevant quality measures as part of their 
participation in a MIPS APM, in order to receive performance-based 
payments. By repurposing these quality measures, we will enable MIPS 
APM participants to avoid duplicative reporting and inconsistent 
incentives between MIPS and APM requirements.
    Comment: Some commenters suggested reweighting the performance 
categories under the APM scoring standard to align with the weights 
used under regular MIPS in 2018.
    Response: While it is our intention to align the policies under the 
APM scoring standard with the generally applicable MIPS policies to the 
greatest extent possible, in this instance we believe alignment is 
inappropriate. As previously noted, under the APM scoring standard, we 
proposed to use our authority to waive the establishment of measures 
and scoring in the cost performance category in all performance periods 
(82 FR 30082), and we are finalizing that proposal in this final rule 
with comment period. As a result, we will not align with the generally 
applicable MIPS performance category weighting.
    Comment: One commenter was confused by Table 12 of the proposed 
rule (82 FR 30088), which indicates that all MIPS APMs will have the 
same performance category weighting, as well as the same reweighting 
standards in the event that a MIPS eligible clinician or TIN is 
exempted from the advancing care information performance category, or 
an APM Entity has no quality measures available to create a quality 
performance category score.
    Response: All MIPS APMs will have their performance categories 
weighted in the same way. For information about performance category 
weighting for MIPS APM under normal circumstances, we refer readers to 
Table 12. For information about performance category weighting in 
special circumstances, such as when a performance category is 
reweighted to zero, we refer readers to Table 13.
    Final Action: After considering public comments, we are finalizing 
the performance category weighting as proposed at Sec.  414.1370(h).
    These final weights are summarized in Table 12.

     Table 12--APM Scoring Standard Performance Category Weights--Beginning With the 2018 Performance Period
----------------------------------------------------------------------------------------------------------------
                                                                                                    Performance
      MIPS performance category           APM entity submission      Performance category score      category
                                               requirement                                          weight (%)
----------------------------------------------------------------------------------------------------------------
Quality.............................  The APM Entity will be        CMS will assign the same                  50
                                       required to submit quality    quality category
                                       measures to CMS as required   performance score to each
                                       by the MIPS APM. Measures     TIN/NPI in an APM Entity
                                       available at the close of     group based on the APM
                                       the MIPS submission period    Entity's total quality
                                       will be used to calculate     score, derived from
                                       the MIPS quality              available APM quality
                                       performance category score.   measures.
                                       If the APM Entity does not
                                       submit any APM required
                                       measures by the MIPS
                                       submission deadline, the
                                       APM Entity will be assigned
                                       a zero.

[[Page 53703]]

 
Cost................................  The APM Entity group will     Not Applicable..............               0
                                       not be assessed on cost
                                       under the APM scoring
                                       standard.
Improvement Activities..............  MIPS eligible clinicians are  CMS will assign the same                  20
                                       not required to report        improvement activities
                                       improvement activities        score to each APM Entity
                                       data; if the CMS-assigned     based on the activities
                                       improvement activities        involved in participation
                                       score is below the maximum    in the MIPS APM. APM
                                       improvement activities        Entities will receive a
                                       score, APM Entities will      minimum of one half of the
                                       have the opportunity to       total possible points. In
                                       submit additional             the event that the assigned
                                       improvement activities to     score does not represent
                                       raise the APM Entity          the maximum improvement
                                       improvement activity score.   activities score, the APM
                                                                     Entity will have the
                                                                     opportunity to report
                                                                     additional improvement
                                                                     activities to add points to
                                                                     the APM Entity level score.
Advancing Care Information..........  Each MIPS eligible clinician  CMS will attribute the same               30
                                       in the APM Entity group is    score to each MIPS eligible
                                       required to report            clinician in the APM Entity
                                       advancing care information    group. This score will be
                                       to MIPS through either        the highest score
                                       group TIN or individual       attributable to the TIN/NPI
                                       reporting.                    combination of each MIPS
                                                                     eligible clinician, which
                                                                     may be derived from either
                                                                     group or individual
                                                                     reporting. The scores
                                                                     attributed to each MIPS
                                                                     eligible clinician will be
                                                                     averaged for a single APM
                                                                     Entity score.
----------------------------------------------------------------------------------------------------------------

    There could be instances where an Other MIPS APM has no measures 
available to score for the quality performance category for a MIPS 
performance period; for example, it is possible that none of the Other 
MIPS APM's measures would be available for calculating a quality 
performance category score by or shortly after the close of the MIPS 
submission period because the measures were removed due to changes in 
clinical practice guidelines. In addition, as we explained in the CY 
2018 Quality Payment Program proposed rule, the MIPS eligible 
clinicians in an APM Entity may qualify for a zero percent weighting 
for the advancing care information performance category (82 FR 30087 
through 30088). In such instances, under the APM scoring standard, we 
proposed to reweight the affected performance category to zero, in 
accordance with section 1848(q)(5)(F) of the Act (82 FR 30088 through 
30089).
    If the quality performance category is reweighted to zero, we 
proposed to reweight the improvement activities and advancing care 
information performance categories to 25 and 75 percent, respectively. 
If the advancing care information performance category is reweighted to 
zero, the quality performance category weight would be increased to 80 
percent.
    We sought comment on these proposals. The following is a summary of 
the comments on these proposals and our responses:
    Comment: A few commenters suggested that in the event an entire 
performance category is unable to be scored, its weight should be 
evenly distributed among the remaining performance categories rather 
than shifted entirely to either quality or advancing care information.
    Response: In a situation where either the quality or advancing care 
information performance categories have been reweighted to zero, we do 
not believe it is appropriate to give any more weight to the 
improvement activities performance category because under the APM 
scoring standard this performance category score is automatically 
assigned, rather than reported and scored like the advancing care 
information and quality performance categories.
    Comment: Some commenters suggested that in the event a second 
performance category (in addition to cost) is weighted to zero, the APM 
Entity or all APM Entities in the APM should receive a neutral score 
for that performance period.
    Response: Our proposed policy of scoring an APM Entity for which 
two or more performance categories are available to be scored is 
consistent with policies finalized in the CY 2017 Quality Payment 
Program final rule, and scoring policies under regular MIPS. We also 
continue to believe that it is appropriate to use the available 
performance category scores in order to encourage the continued 
performance and reporting of measures in any performance category that 
is available, including the advancing care information performance 
category, which is not necessarily required under the terms of MIPS 
APMs. Having data for as many performance categories as possible is 
also important for purposes of calculating improvement scoring in 
future years and in helping to calculate MIPS payment adjustments.
    Final Action: After considering public comments, we are finalizing 
our proposals. If the quality performance category is reweighted to 
zero, we will reweight the improvement activities and advancing care 
information performance categories to 25 and 75 percent, respectively. 
If the advancing care information performance category is reweighted to 
zero, the quality performance category weight will be increased to 80 
percent and the improvement activities performance category will remain 
at 20 percent. The final policies are summarized in Table 13. We are 
finalizing this policy at Sec.  414.1370(h)(5).

[[Page 53704]]



Table 13--APM Scoring Standard Performance Category Weights for MIPS APMs With Performance Categories Weighted to 0--Beginning With the 2018 Performance
                                                                         Period
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Performance
                                                                                                                            Performance      category
                                                                                                                             category       weight (no
       MIPS performance category           APM entity submission requirement            Performance category score          weight (no    advancing care
                                                                                                                           quality) (%)    information)
                                                                                                                                                (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality...............................  The APM Entity will not be assessed on   CMS will assign the same quality                      0              80
                                         quality under MIPS if no quality data    category performance score to each TIN/
                                         are available at the close of the MIPS   NPI in an APM Entity group based on
                                         submission period. The APM Entity will   the APM Entity's total quality score,
                                         submit quality measures to CMS as        derived from available APM quality
                                         required by the Other MIPS APM.          measures.
Cost..................................  The APM Entity group will not be         Not Applicable.........................               0               0
                                         assessed on cost under APM scoring
                                         standard.
Improvement Activities................  MIPS eligible clinicians are not         CMS will assign the same improvement                 25              20
                                         required to report improvement           activities score to each APM Entity
                                         activities data unless the CMS-          group based on the activities involved
                                         assigned improvement activities score    in participation in the MIPS APM.
                                         is below the maximum improvement        APM Entities will receive a minimum of
                                         activities score.                        one half of the total possible points.
                                                                                  In the event that the assigned score
                                                                                  does not represent the maximum
                                                                                  improvement activities score, the APM
                                                                                  Entity will have the opportunity to
                                                                                  report additional improvement
                                                                                  activities to add points to the APM
                                                                                  Entity level score.
Advancing Care Information............  Each MIPS eligible clinician in the APM  CMS will attribute the same score to                 75               0
                                         Entity group reports advancing care      each MIPS eligible clinician in the
                                         information to MIPS through either       APM Entity group. This score will be
                                         group TIN or individual reporting.       the highest score attributable to the
                                                                                  TIN/NPI combination of each MIPS
                                                                                  eligible clinician, which may be
                                                                                  derived from either group or
                                                                                  individual reporting. The scores
                                                                                  attributed to each MIPS eligible
                                                                                  clinicians will be averaged for a
                                                                                  single APM Entity score. For
                                                                                  participants in the Shared Savings
                                                                                  Program, advancing care information
                                                                                  will be scored at the TIN level. A TIN
                                                                                  will be exempt from reporting only if
                                                                                  all MIPS eligible clinicians billing
                                                                                  through the TIN qualify for a zero
                                                                                  percent weighting of the advancing
                                                                                  care information performance category.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(b) Risk Factor Score
    Section 1848(q)(1)(G) of the Act requires us to consider risk 
factors in our scoring methodology. Specifically, that section provides 
that the Secretary, on an ongoing basis, shall, as the Secretary 
determines appropriate and based on individuals' health status and 
other risk factors, assess appropriate adjustments to quality measures, 
cost measures, and other measures used under MIPS and assess and 
implement appropriate adjustments to payment adjustments, final scores, 
scores for performance categories, or scores for measures or activities 
under the MIPS.
    We did not be create a separate methodology to adjust for patient 
risk factors for purposes of the APM scoring standard. However, we 
refer readers to section II.C.7.b.(1)(b) of this final rule with 
comment period for a description of the complex patient bonus and its 
application to APM Entities.
(c) Small Practice Bonus
    We believe an adjustment for eligible clinicians in small practices 
(referred to herein as the small practice bonus) is appropriate to 
recognize barriers faced by small practices, such as unique challenges 
related to financial and other resources, environmental factors, and 
access to health information technology, and to incentivize eligible 
clinicians in small practices to participate in the Quality Payment 
Program and to overcome any performance discrepancy due to practice 
size.
    We refer readers to section II.C.7.b (1)(c) of this final rule with 
comment period for a discussion of the small practice adjustment and 
its application to APM Entities.
(d) Final Score Methodology
    In the CY 2017 Quality Payment Program final rule, we finalized the 
methodology for calculating a final score of 0-100 based on the four 
performance categories (81 FR 77320). We refer readers to section 
II.C.7.b. of this final rule for a discussion of the changes we are 
making to the final score methodology. We are codifying our policy 
pertaining to the calculation of the total APM Entity score at Sec.  
414.1370(i).
(5) MIPS APM Performance Feedback
    In the CY 2017 Quality Payment Program final rule, we finalized 
that all MIPS eligible clinicians scored under

[[Page 53705]]

the APM scoring standard will receive performance feedback as specified 
under section 1848(q)(12) of the Act on the quality and cost 
performance categories to the extent applicable, based on data 
collected in the September 2016 QRUR, unless they did not have data 
included in the September 2016 QRUR. Those eligible clinicians without 
data included in the September 2016 QRUR will not receive any 
performance feedback until performance data is available for feedback 
(81 FR 77270).
    Beginning with the 2018 performance period, we proposed that MIPS 
eligible clinicians whose MIPS payment adjustment is based on their 
score under the APM scoring standard will receive performance feedback 
as specified under section 1848(q)(12) of the Act for the quality, 
advancing care information, and improvement activities performance 
categories to the extent data are available for the MIPS performance 
period (82 FR 30089 through 30090). Further, we proposed that in cases 
where performance data are not available for a MIPS APM performance 
category or the MIPS APM performance category has been weighted to zero 
for that performance period, we would not provide performance feedback 
on that MIPS performance category.
    We believe that with an APM Entity's finite resources for engaging 
in efforts to improve quality and lower costs for a specified 
beneficiary population, the incentives of the APM must take priority 
over those offered by MIPS in order to ensure that the goals and 
evaluation associated with the APM are as clear and free of confounding 
factors as possible. The potential for different, conflicting messages 
in performance feedback provided by the APMs and that provided by MIPS 
may create uncertainty for MIPS eligible clinicians who are attempting 
to strategically transform their respective practices and succeed under 
the terms of the APM. Accordingly, under sections 1115A(d)(1) and 
1899(f) of the Act, for all MIPS performance periods we proposed to 
waive--for MIPS eligible clinicians participating in MIPS APMs 
authorized under sections 1115A and 1899 of the Act, respectively--the 
requirement under section 1848(q)(12)(A)(i)(I) of the Act to provide 
performance feedback for the cost performance category.
    We requested comment on these proposals to waive requirements for 
performance feedback on the cost performance category beginning in the 
2018 performance year, and for the other performance categories in 
years for which the weight for those categories has been reweighted to 
zero.
    The following is a summary of the public comments we received and 
our responses:
    Comment: Several commenters supported our proposal.
    Response: We thank commenters for their support of this policy.
    Final Action: After considering public comments, we are finalizing 
the policy on performance feedback for MIPS eligible clinicians 
participating in MIPS APMs as proposed.
(6) Summary of Final Policies
    In summary, we are finalizing the following policies in this 
section:
     We are finalizing our proposal to define full TIN APM at 
Sec.  414.1305 and to amend Sec.  414.1370(e) to identify the four 
assessment dates that would be used to identify the APM Entity group 
for full TIN APMs for purposes of the APM scoring standard, and to 
specify that the December 31 date will be used only to identify MIPS 
eligible clinicians on the APM Entity's Participation List for a MIPS 
APM that is a full TIN APM in order to add them to the APM Entity group 
that is scored under the APM scoring standard. We will use this fourth 
assessment date of December 31 only to extend the APM scoring standard 
to those MIPS eligible clinicians participating in MIPS APMs that are 
full TIN APMs, ensuring that a MIPS eligible clinician who joins a full 
TIN APM late in the performance period would be scored under the APM 
scoring standard.
     We are finalizing our proposal to continue to weight the 
cost performance category under the APM scoring standard for Web 
Interface reporters at zero percent beginning with the 2020 MIPS 
payment year.
     We are finalizing our proposal not to take improvement 
into account for performance scores in the cost performance category 
for Web Interface reporters beginning with the 2020 MIPS payment year 
to align with our final policy of weighting the cost performance 
category at zero percent.
     We finalizing our proposal to score the CAHPS for ACOs 
survey in addition to the Web Interface measures to calculate the MIPS 
APM quality performance category score for Web Interface reporters 
(including MIPS eligible clinicians participating in the Shared Savings 
Program and Next Generation ACO Model), beginning in the 2018 
performance period at Sec.  414.1370(e).
     We are finalizing our proposal that, beginning with the 
2018 performance period, MIPS eligible clinicians in Web Interface 
reporters may receive bonus points under the APM scoring standard for 
submitting the CAHPS for ACOs survey.
     We are finalizing our proposal to calculate the quality 
improvement score for MIPS eligible clinicians submitting quality 
measures via the Web Interface using the methodology described in 
section II.C.7.a.(2) of this final rule with comment period at Sec.  
414.1370(g)(1)(i)(B).
     We are finalizing our proposal to calculate the total 
quality percent score for MIPS eligible clinicians using the Web 
Interface according to the methodology described in section 
II.C.7.a.(2) of this final rule with comment period at Sec.  
414.1370(g)(1)(i)(C).
     We are finalizing our proposal to establish a separate 
MIPS APM measure list of quality measures for each Other MIPS APM, 
which will be the quality measure list used for purposes of the APM 
scoring standard for that Other MIPS APM.
     We are finalizing our proposals to calculate the MIPS 
quality performance category score for Other MIPS APMs using MIPS APM-
specific quality measures. For purposes of the APM scoring standard, we 
will score only measures that: (1) Are tied to payment as described 
under the terms of the APM, (2) are available for scoring near the 
close of the MIPS submission period, (3) have a minimum of 20 cases 
available for reporting, and (4) have an available benchmark at Sec.  
414.1370(g)(1)(ii)(A)(1) through (4).
     We are finalizing our proposal to only use the MIPS APM 
quality measure data that are submitted by the close of the MIPS 
submission period and are available for scoring in time for inclusion 
to calculate a MIPS quality performance category score.
     We are finalizing our proposal that, for the APM scoring 
standard, the benchmark score used for a quality measure would be the 
benchmark used in the MIPS APM for calculation of the performance based 
payments, where such a benchmark is available. If the APM does not 
produce a benchmark score for a reportable measure that is included on 
the APM measures list, we will use the benchmark score for the measure 
that is used for the MIPS quality performance category generally for 
that performance period, provided the measure specifications for the 
measure are the same under both the MIPS final list and the MIPS APM 
measures list.
     We are finalizing our proposal that the minimum number of 
quality measures required to be reported for the

[[Page 53706]]

APM scoring standard would be the minimum number of quality measures 
that are required within the MIPS APM and are collected and available 
in time to be included in the calculation for the APM Entity score 
under the APM scoring standard. We are also finalizing our proposal 
that that if an APM Entity submits some, but not all of the measures 
required by the MIPS APM by the close of the MIPS submission period, 
the APM Entity would receive points for the measures that were 
submitted, but would receive a score of zero for each remaining measure 
between the number of measures reported and the number of measures 
required by the APM that were available for scoring.
     We are finalizing our proposal that the benchmark score 
used for a quality measure would be the benchmark used by the MIPS APM 
for calculation of the performance based payments within the APM, if 
possible, in order to best align the measure performance outcomes 
between the Quality Payment Program and the APM. We are finalizing our 
proposal that for measures that are pay-for-reporting or that do not 
measure performance on a continuum of performance, we will consider 
these measures to be lacking a benchmark and treat them as such.
     We are finalizing our proposal to score quality measure 
performance under the APM scoring standard using a percentile 
distribution, separated by decile categories, as described in the 
finalized MIPS quality scoring methodology. We are also finalizing our 
proposal to use a graduated points-assignment approach, where a measure 
is assigned a continuum of points out to one decimal place, based on 
its place in the decile.
     We are finalizing our proposal that each APM Entity that 
reports on quality measures would receive between 1 and 10 achievement 
points for each measure reported that can be reliably scored against a 
benchmark, up to the number of measures that are required to be 
reported by the APM.
     We are finalizing our proposal that MIPS eligible 
clinicians in APM Entities participating in MIPS APMs, like other MIPS 
eligible clinicians, would be eligible to receive bonus points for the 
MIPS quality performance category for reporting on high priority 
measures or measures submitted via CEHRT. For each Other MIPS APM, we 
are finalizing our proposal to identify whether any of the available 
measures meets the criteria to receive a bonus, and add the bonus 
points to the quality achievement points.
     We are finalizing our proposal to score improvement as 
well as achievement in the quality performance category beginning in 
the 2018 performance period at Sec.  414.1370(g)(1)(ii)(B). For the APM 
scoring standard, the improvement percentage points will be awarded 
based on the following formula:

Quality Improvement Score = (Absolute Improvement/Previous Year Quality 
Performance Category Percent Score Prior to Bonus Points) * 10

     We are finalizing our proposal that the APM Entity's total 
quality performance category score would be equal to [(achievement 
points + bonus points)/total available achievement points] + quality 
improvement score. We are codifying this policy at Sec.  
414.1370(g)(1)(ii)(C).
     We are finalizing at Sec.  414.1370(g)(4)(iii), our 
proposal for scoring the advancing care information performance 
category if a MIPS eligible clinician who qualifies for a zero percent 
weighting of the advancing are information performance category. This 
policy will apply beginning with the 2019 payment year.
     We are finalizing our proposal to maintain the cost 
performance category weight of zero for all MIPS APMs under the APM 
scoring standard for the 2020 MIPS payment year and subsequent MIPS 
payment years. Because the cost performance category will be reweighted 
to zero, that weight will be redistributed to other performance 
categories. We are finalizing our policy to align the Other MIPS APM 
performance category weights with those for Web Interface reporters and 
weight the quality performance category to 50 percent, the improvement 
activities performance category to 20 percent, and the advancing care 
information performance category to 30 percent of the APM Entity final 
score for all MIPS APMs at Sec.  414.1370(h)(1) through (4).
     We are finalizing our proposal to reweight the quality 
performance category to zero under the APM scoring standard in 
instances where none of a MIPS APM's measures will be available for 
calculating a quality performance category score by or shortly after 
the close of the MIPS submission period, for example, due to changes in 
clinical practice guidelines. In addition, the MIPS eligible clinicians 
in an APM Entity may qualify for a zero percent weighting for the 
advancing care information performance category.
     We are finalizing our proposal that MIPS eligible 
clinicians whose MIPS payment adjustment is based on their score under 
the APM scoring standard will receive performance feedback as specified 
under section 1848(q)(12) of the Act for the quality, advancing care 
information, and improvement activities performance categories to the 
extent data are available for the MIPS performance period. Further, we 
are finalizing our proposal that in cases where the MIPS APM 
performance category has been weighted to zero for a performance 
period, we will not provide performance feedback on that MIPS 
performance category. We are also finalizing our proposal to waive, 
using our authority under sections 1115A(d)(1) and 1899(f) of the Act, 
the requirement under section 1848(q)(12)(A)(i)(I) of the Act to 
provide performance feedback for the cost performance category for MIPS 
eligible clinicians participating in MIPS APMs authorized under 
sections 1115A and 1899 of the Act, respectively; this waiver will be 
applicable in all years, regardless of the availability of cost 
performance data for MIPS eligible clinicians participating in these 
MIPS APMs.
     We are finalizing at section II.C.4.b. of this final rule 
with comment period to apply the APM scoring standard score when 
calculating the MIPS payment adjustment for MIPS eligible clinicians 
participating in MIPS APMs, even for those whose TINs are participating 
in a virtual group. We are codifying this policy at Sec.  
414.1370(f)(2).
     We are not finalizing our proposal to amend Sec.  
414.1370(b)(4)(i).
(7) Measure Sets
    We sought comment on Tables 14, 15, and 16 in the CY 2018 Quality 
Payment Program proposed rule (82 FR 30091through 30095), which 
outlined the measures being introduced for notice and comment, and 
would serve as the measure set used by participants in the identified 
MIPS APMs in order to create a MIPS score under the APM scoring 
standard, as described in section II.C.6.g.(3)(b)(ii) of this final 
rule with comment period.
    The following is a summary of the public comments we received and 
our responses:
    Comment: One commenter requested that CMS include more immunization 
measures for all MIPS APMs, specifically the Comprehensive ESRD Care 
and Comprehensive Primary Care Plus (CPC+) APMs:
 NQF #0041/PQRS #110: Influenza Immunization in the ESRD 
Population
 NQF #0043/PQRS #111: Pneumococcal Vaccination Status
 For the Comprehensive Primary Care Plus (CPC+) APM:26

[[Page 53707]]

++ NQF #0041/PQRS #110: Influenza Immunization
++ NQF #0043/PQRS #111: Pneumonia Vaccination Status for Older Adults

    Response: The MIPS APM measures list is comprised of only measures 
that are already in effect under the terms of the MIPS APMs. The 
addition of measures to MIPS APMs is a function of each APM's model 
design and objectives and is determined by the terms of each MIPS APM.
    Comment: One commenter objected to the use of CMS 166v6 (MIPS ID 
312) Use of Imaging Studies for Low Back Pain for the CPC+ Model. The 
commenter suggested the requirements of the measure to be overly 
general, and that the measure may cause the intervention to be 
inappropriately applied because exclusion criteria were too limited and 
not all indications for the intervention were included in the measure 
requirements. The commenter further objected to the benchmark for the 
measure, which requires 100 percent performance to achieve a perfect 
score.
    Response: The MIPS APM measure list is comprised of measures that 
are used under the terms of each MIPS APM. Because this measure has 
been removed from the CPC+ measure list for the 2018 performance year, 
we will also be removing it from the 2018 MIPS APM measure list for APM 
Entities participating in the CPC+ Model.
    Comment: One commenter objected to the use of CMS 156v5 (MIPS ID 
238) Use of High-Risk Medications in the Elderly (inverse metric) for 
the CPC+ Model. The commenter stated that the benchmark thresholds are 
effectively unattainable and therefore may reduce the incentive for 
clinicians to strive for performance beyond the minimum 50th 
percentile; further, the commenter stated that with an 80th percentile 
benchmark of 0.01 percent, clinicians do not believe that the benchmark 
is valid or appropriate for the best interests of their varied patient 
population.
    Response: The MIPS APM measure list is comprised of measures that 
are used under the terms of each MIPS APM. Because this measure has 
been removed from the Comprehensive Primary Care Plus measure list for 
the 2018 performance year, we will also be removing it from the 2018 
MIPS APM measure list for APM Entities participating in CPC+.
    Comment: One commenter objected to the use of CMS 131v5 (MIPS ID 
117) Diabetes: Eye Exam for CPC+ because the benchmarks for the measure 
may be appropriate for ophthalmologists or optometrists, but the 80th 
percentile decile of 99.99 percent is inappropriate for primary care 
providers like those participating in CPC+.
    Response: CPC+ uses the MIPS benchmarks for electronic clinical 
quality measures (eCQMs). These benchmarks are based on data reported 
to CMS by all clinicians--primary care and specialists. The 2017 
benchmarks were based on data submitted in 2015 to the Physician 
Quality Reporting System. The percentile standards mentioned in the 
comment are MIPS percentile standards.
    Final Action: After considering public comments, we are finalizing 
the MIPS APM measure sets as follows in Tables 14, 15, and 16. We note 
that some proposed measures have been removed from these MIPS APM 
measure lists because the measures have been removed from use under the 
terms of the individual APM, and therefore in order to maintain 
alignment between the APM scoring standard and the APMs, we have also 
removed these measures from the MIPS APM measures list. We have also 
updated the below measure list to reflect updates to measure 
descriptions provided by the measure stewards, as well as corrected 
National Quality Strategy Domains in alignment with the most recent 
MIPS APM measure lists.

                              Table 14--MIPS APM Measures List--Oncology Care Model
----------------------------------------------------------------------------------------------------------------
                                 NQF/quality No. (if   National quality         Measure         Primary measure
          Measure name               applicable)        strategy domain       description           steward
----------------------------------------------------------------------------------------------------------------
Risk-adjusted proportion of      Not Applicable.....  Effective Clinical  Percentage of OCM-  Not Applicable.
 patients with all-cause                               Care.               attributed FFS
 hospital admissions within the                                            beneficiaries who
 6-month episode.                                                          were had an acute-
                                                                           care hospital
                                                                           stay during the
                                                                           measurement
                                                                           period.
Risk-adjusted proportion of      Not Applicable.....  Effective Clinical  Percentage of OCM-  Not Applicable.
 patients with all-cause ED                            Care.               attributed FFS
 visits or observation stays                                               beneficiaries who
 that did not result in a                                                  had an ER visit
 hospital admission within the                                             that did not
 6-month episode.                                                          result in a
                                                                           hospital stay
                                                                           during the
                                                                           measurement
                                                                           period.
Proportion of patients who died  Not Applicable.....  Effective Clinical  Percentage of OCM-  Not Applicable.
 who were admitted to hospice                          Care.               attributed FFS
 for 3 days or more.                                                       beneficiaries who
                                                                           died and spent at
                                                                           least 3 days in
                                                                           hospice during
                                                                           the measurement
                                                                           time period.
Oncology: Medical and            0384/143...........  Person and          Percentage of       Physician
 Radiation--Pain Intensity                             Caregiver           patient visits,     Consortium for
 Quantified.                                           Centered            regardless of       Performance
                                                       Experience.         patient age, with   Improvement
                                                                           a diagnosis of      Foundations
                                                                           cancer currently    (PCPI).
                                                                           receiving
                                                                           chemotherapy or
                                                                           radiation therapy
                                                                           in which pain
                                                                           intensity is
                                                                           quantified.
Oncology: Medical and            0383/144...........  Person and          Percentage of       American Society
 Radiation--Plan of Care for                           Caregiver           visits for          of Clinical
 Pain.                                                 Centered            patients,           Oncology.
                                                       Experience.         regardless of
                                                                           age, with a
                                                                           diagnosis of
                                                                           cancer currently
                                                                           receiving
                                                                           chemotherapy or
                                                                           radiation therapy
                                                                           who report having
                                                                           pain with a
                                                                           documented plan
                                                                           of care to
                                                                           address pain.
Preventive Care and Screening:   0418/134...........  Community/          Percentage of       Centers for
 Screening for Depression and                          Population Health.  patients aged 12    Medicare &
 Follow-Up Plan.                                                           and older           Medicaid
                                                                           screened for        Services.
                                                                           depression on the
                                                                           date of the
                                                                           encounter using
                                                                           an age
                                                                           appropriate
                                                                           standardized
                                                                           depression
                                                                           screening tool
                                                                           and if positive,
                                                                           a follow-up plan
                                                                           is documented on
                                                                           the date of the
                                                                           positive screen.
Patient-Reported Experience of   Not Applicable.....  Person and          Summary/Survey      Not Applicable.
 Care.                                                 Caregiver           Measures may
                                                       Centered            include:
                                                       Experience.        --Overall measure
                                                                           of patient
                                                                           experience..
                                                                          --Exchanging
                                                                           Information with
                                                                           Patients..
                                                                          --Access..........
                                                                          --Shared Decision
                                                                           Making..
                                                                          --Enabling Self-
                                                                           Management..
                                                                          --Affective
                                                                           Communication..

[[Page 53708]]

 
Prostate Cancer: Adjuvant        0390/104...........  Effective Clinical  Percentage of       American
 Hormonal Therapy for High or                          Care.               patients,           Urological
 Very High Risk Prostate Cancer.                                           regardless of       Association
                                                                           age, with a         Education and
                                                                           diagnosis of        Research.
                                                                           prostate cancer
                                                                           at high or very
                                                                           high risk of
                                                                           recurrence
                                                                           receiving
                                                                           external beam and
                                                                           radiotherapy to
                                                                           the prostate who
                                                                           were prescribed
                                                                           adjuvant hormonal
                                                                           therapy (GnRH
                                                                           [gonadotropin
                                                                           releasing
                                                                           hormone] agonist
                                                                           or antagonist).
Adjuvant chemotherapy is         0223...............  Communication and   Percentage of       Commission on
 recommended or administered                           Care Coordination.  patients under      Cancer, American
 within 4 months (120 days) of                                             the age of 80       College of
 diagnosis to patients under                                               with AJCC III       Surgeons.
 the age of 80 with AJCC III                                               (lymph node
 (lymph node positive) colon                                               positive) colon
 cancer.                                                                   cancer for whom
                                                                           adjuvant
                                                                           chemotherapy is
                                                                           recommended and
                                                                           not received or
                                                                           administered
                                                                           within 4 months
                                                                           (120 days) of
                                                                           diagnosis.
Combination chemotherapy is      0559...............  Communication and   Percentage of       Commission on
 recommended or administered                           Care Coordination.  female patients,    Cancer, American
 within 4 months (120 days) of                                             age >18 at          College of
 diagnosis for women under 70                                              diagnosis, who      Surgeons.
 with AJCC T1cN0M0, or Stage IB-                                           have their first
 III hormone receptor negative                                             diagnosis of
 breast cancer.                                                            breast cancer
                                                                           (epithelial
                                                                           malignancy), at
                                                                           AJCC stage
                                                                           T1cN0M0 (tumor
                                                                           greater than 1
                                                                           cm), or Stage IB-
                                                                           III, whose
                                                                           primary tumor is
                                                                           progesterone and
                                                                           estrogen receptor
                                                                           negative
                                                                           recommended for
                                                                           multiagent
                                                                           chemotherapy
                                                                           (recommended or
                                                                           administered)
                                                                           within 4 months
                                                                           (120 days) of
                                                                           diagnosis.
Trastuzumab administered to      1858/450...........  Efficiency and      Proportion of       American Society
 patients with AJCC stage I                            Cost Reduction.     female patients     of Clinical
 (T1c)-III and human epidermal                                             (aged 18 years      Oncology.
 growth factor receptor 2                                                  and older) with
 (HER2) positive breast cancer                                             AJCC stage I
 who receive adjuvant                                                      (Tlc)-Ill, human
 chemotherapy.                                                             epidermal growth
                                                                           factor receptor 2
                                                                           (HER2) positive
                                                                           breast cancer
                                                                           receiving
                                                                           adjuvant
                                                                           Chemotherapy.
Breast Cancer: Hormonal Therapy  0387...............  Communication and   Percentage of       AMA-convened
 for Stage I (T1b)-IIIC                                Care Coordination.  female patients     Physician
 Estrogen Receptor/Progesterone                                            aged 18 years and   Consortium for
 Receptor (ER/PR) Positive                                                 older with Stage    Performance
 Breast Cancer.                                                            I (T1b) through     Improvement.
                                                                           IIIC, ER or PR
                                                                           positive breast
                                                                           cancer who were
                                                                           prescribed
                                                                           tamoxifen or
                                                                           aromatase
                                                                           inhibitor (AI)
                                                                           during the 12-
                                                                           month reporting
                                                                           period.
Documentation of Current         0419/130...........  Patient Safety....  Percentage of       Centers for
 Medications in the Medical                                                visits for          Medicare &
 Record.                                                                   patients aged 18    Medicaid
                                                                           years and older     Services.
                                                                           for which the
                                                                           eligible
                                                                           clinician attests
                                                                           to documenting a
                                                                           list of current
                                                                           medications using
                                                                           all immediate
                                                                           resources
                                                                           available on the
                                                                           date of the
                                                                           encounter. This
                                                                           list must include
                                                                           ALL known
                                                                           prescriptions,
                                                                           over-the
                                                                           counters,
                                                                           herbals, and
                                                                           vitamin/mineral/
                                                                           dietary AND must
                                                                           contain the
                                                                           medications'
                                                                           name, dosage,
                                                                           frequency and
                                                                           route of
                                                                           administration.
----------------------------------------------------------------------------------------------------------------


                            Table 15--MIPS APM Measures List--Comprehensive ESRD Care
----------------------------------------------------------------------------------------------------------------
                                  NQF/quality No.    National quality                           Primary measure
         Measure name             (if applicable)    strategy domain     Measure description        steward
----------------------------------------------------------------------------------------------------------------
ESCO Standardized Mortality     0369/154..........  Patient Safety...  This measure is         National
 Ratio.                                                                 calculated as a ratio   Committee for
                                                                        but can also be         Quality
                                                                        expressed as a rate.    Assurance.
Falls: Screening, Risk          0101/154..........  Communication and  (A) Screening for       National
 Assessment and Plan of Care                         Coordination.      Future Fall Risk:       Committee for
 to Prevent Future Falls.                                               Patients who were       Quality
                                                                        screened for future     Assurance.
                                                                        fall risk at last
                                                                        once within 12 months.
                                                                       (B) Multifactorial
                                                                        Falls Risk
                                                                        Assessment: Patients
                                                                        at risk of future
                                                                        fall who had a
                                                                        multifactorial risk
                                                                        assessment for falls
                                                                        completed within 12
                                                                        months.
                                                                       (C) Plan of Care to
                                                                        Prevent Future Falls:
                                                                        Patients at risk of
                                                                        future fall with a
                                                                        plan of care for
                                                                        falls prevention
                                                                        documented within 12
                                                                        months.
Advance Care Plan.............  0326/47...........  Patient Safety...  Percentage of patients  National
                                                                        aged 65 years and       Committee for
                                                                        older who have an       Quality
                                                                        advance care plan or    Assurance.
                                                                        surrogate decision
                                                                        maker documented in
                                                                        the medical record or
                                                                        documentation in the
                                                                        medical record that
                                                                        an advance care plan
                                                                        was discussed but the
                                                                        patient did not wish
                                                                        or was not able to
                                                                        name a surrogate
                                                                        decision maker or
                                                                        provide an advance
                                                                        care plan.

[[Page 53709]]

 
ICH-CAHPS: Nephrologists'       0258..............  Person and         Summary/Survey          Agency for
 Communication and Caring.                           Caregiver          Measures may include:   Healthcare
                                                     Centered          --Getting timely care,   Research and
                                                     Experience and     appointments, and       Quality.
                                                     Outcome.           information..
                                                                       --How well providers
                                                                        communicate..
                                                                       --Patients' rating of
                                                                        provider..
                                                                       --Access to
                                                                        specialists..
                                                                       --Health promotion and
                                                                        education..
                                                                       --Shared Decision-
                                                                        making..
                                                                       --Health status and
                                                                        functional status..
                                                                       --Courteous and
                                                                        helpful office staff..
                                                                       --Care coordination...
                                                                       --Between visit
                                                                        communication..
                                                                       --Helping you to take
                                                                        medications as
                                                                        directed, and.
                                                                       --Stewardship of
                                                                        patient resources..
ICH-CAHPS: ICH-CAHPS: Rating    0258..............  Person and         Comparison of services  Not Applicable.
 of Dialysis Center.                                 Caregiver          and quality of care
                                                     Centered           that dialysis
                                                     Experience and     facilities provide
                                                     Outcome.           from the perspective
                                                                        of ESRD patients
                                                                        receiving in-center
                                                                        hemodialysis care.
                                                                        Patients will assess
                                                                        their dialysis
                                                                        providers, including
                                                                        nephrologists and
                                                                        medical and non-
                                                                        medical staff, the
                                                                        quality of dialysis
                                                                        care they receive,
                                                                        and information
                                                                        sharing about their
                                                                        disease.
ICH-CAHPS: Quality of Dialysis  0258..............  Person and         Comparison of services  Agency for
 Center Care and Operations.                         Caregiver          and quality of care     Healthcare
                                                     Centered           that dialysis           Research and
                                                     Experience and     facilities provide      Quality.
                                                     Outcome.           from the perspective
                                                                        of ESRD patients
                                                                        receiving in-center
                                                                        hemodialysis care.
                                                                        Patients will assess
                                                                        their dialysis
                                                                        providers, including
                                                                        nephrologists and
                                                                        medical and non-
                                                                        medical staff, the
                                                                        quality of dialysis
                                                                        care they receive,
                                                                        and information
                                                                        sharing about their
                                                                        disease.
ICH-CAHPS: Providing            0258..............  Person and         Comparison of services  Agency for
 Information to Patients.                            Caregiver          and quality of care     Healthcare
                                                     Centered           that dialysis           Research and
                                                     Experience and     facilities provide      Quality.
                                                     Outcome.           from the perspective
                                                                        of ESRD patients
                                                                        receiving in-center
                                                                        hemodialysis care.
                                                                        Patients will assess
                                                                        their dialysis
                                                                        providers, including
                                                                        nephrologists and
                                                                        medical and non-
                                                                        medical staff, the
                                                                        quality of dialysis
                                                                        care they receive,
                                                                        and information
                                                                        sharing about their
                                                                        disease.
ICH-CAHPS: Rating of Kidney     0258..............  Person and         Comparison of services  Agency for
 Doctors.                                            Caregiver          and quality of care     Healthcare
                                                     Centered           that dialysis           Research and
                                                     Experience and     facilities provide      Quality.
                                                     Outcome.           from the perspective
                                                                        of ESRD patients
                                                                        receiving in-center
                                                                        hemodialysis care.
                                                                        Patients will assess
                                                                        their dialysis
                                                                        providers, including
                                                                        nephrologists and
                                                                        medical and non-
                                                                        medical staff, the
                                                                        quality of dialysis
                                                                        care they receive,
                                                                        and information
                                                                        sharing about their
                                                                        disease.
ICH-CAHPS: Rating of Dialysis   0258..............  Person and         Comparison of services  Agency for
 Center Staff.                                       Caregiver          and quality of care     Healthcare
ICH-CAHPS: Rating of Dialysis                        Centered           that dialysis           Research and
 Center.                                             Experience and     facilities provide      Quality.
                                                     Outcome.           from the perspective
                                                                        of ESRD patients
                                                                        receiving in-center
                                                                        hemodialysis care.
                                                                        Patients will assess
                                                                        their dialysis
                                                                        providers, including
                                                                        nephrologists and
                                                                        medical and non-
                                                                        medical staff, the
                                                                        quality of dialysis
                                                                        care they receive,
                                                                        and information
                                                                        sharing about their
                                                                        disease.
Medication Reconciliation Post  0554..............  Communication and  The percentage of       National
 Discharge.                                          Care               discharges from any     Committee for
                                                     Coordination.      inpatient facility      Quality
                                                                        (e.g. hospital,         Assurance.
                                                                        skilled nursing
                                                                        facility, or
                                                                        rehabilitation
                                                                        facility) for
                                                                        patients 18 years of
                                                                        age and older seen
                                                                        within 30 days
                                                                        following the
                                                                        discharge in the
                                                                        office by the
                                                                        physicians,
                                                                        prescribing
                                                                        practitioner,
                                                                        registered nurse, or
                                                                        clinical pharmacist
                                                                        providing on-going
                                                                        care for whom the
                                                                        discharge medication
                                                                        list was reconciled
                                                                        with the current
                                                                        medication list in
                                                                        the outpatient
                                                                        medical record.
                                                                       This measure is
                                                                        reported as three
                                                                        rates stratified by
                                                                        age group:
                                                                        Reporting
                                                                        Criteria 1: 18-64
                                                                        years of age..
                                                                        Reporting
                                                                        Criteria 2: 65 years
                                                                        and older..
                                                                        Total Rate:
                                                                        All patients 18 years
                                                                        of age and Older..
Diabetes Care: Eye Exam.......  0055/117..........  Effective          Percentage of patients  National
                                                     Clinical Care.     18-75 years of age      Committee for
                                                                        with diabetes who had   Quality
                                                                        a retinal or dilated    Assurance.
                                                                        eye exam by an eye
                                                                        care professional
                                                                        during the
                                                                        measurement period or
                                                                        a negative retinal
                                                                        exam (no evidence of
                                                                        retinopathy) in the
                                                                        12 months prior to
                                                                        the measurement
                                                                        period.
Diabetes Care: Foot Exam......  0056/163..........  Effective          Percentage of patients  National
                                                     Clinical Care.     18-75 years of age      Committee for
                                                                        with diabetes (type 1   Quality
                                                                        and type 2) who         Assurance,
                                                                        received a foot exam
                                                                        (visual inspection
                                                                        and sensory exam with
                                                                        mono filament and a
                                                                        pulse exam) during
                                                                        the previous
                                                                        measurement year.
Influenza Immunization for the  0041/110, 0226....  Community/         Percentage of patients  Kidney Care
 ESRD Population.                                    Population         aged 6 months and       Quality Alliance
                                                     Health.            older seen for a        (KCQA).
                                                                        visit between July 1
                                                                        and March 31 who
                                                                        received an influenza
                                                                        immunization OR who
                                                                        reported previous
                                                                        receipt of an
                                                                        influenza
                                                                        immunization.
Pneumococcal Vaccination        0043/111..........  Community/         Percentage of patients  National
 Status.                                             Population         65 years of age and     Committee for
                                                     Health.            older who have ever     Quality
                                                                        received a              Assurance.
                                                                        pneumococcal vaccine.

[[Page 53710]]

 
Screening for Clinical          0418/134..........  Community/         Percentage of patients  Centers for
 Depression and Follow-Up Plan.                      Population         aged 12 and older       Medicare and
                                                     Health.            screened for            Medicaid
                                                                        depression on the       Services.
                                                                        date of the encounter
                                                                        and using an age
                                                                        appropriate
                                                                        standardized
                                                                        depression screening
                                                                        tool AND if positive,
                                                                        a follow-up plan is
                                                                        documented on the
                                                                        date of the positive
                                                                        screen.
Tobacco Use: Screening and      0028/226..........  Community/         Percentage of patients  Physician
 Cessation Intervention.                             Population         aged 18 years and       Consortium for
                                                     Health.            older who were          Performance
                                                                        screened for tobacco    Improvement
                                                                        use one or more times   Foundations
                                                                        within 24 months AND    (PCPI).
                                                                        who received
                                                                        cessation counseling
                                                                        intervention if
                                                                        identified as a
                                                                        tobacco user.
----------------------------------------------------------------------------------------------------------------


                    Table 16--MIPS APM Measures List--Comprehensive Primary Care Plus (CPC+)
----------------------------------------------------------------------------------------------------------------
                                  NQF/quality No.    National quality                           Primary measure
         Measure name             (if applicable)    strategy domain     Measure description        steward
----------------------------------------------------------------------------------------------------------------
Controlling High Blood          0018/236..........  Effective          Percentage of patients  National
 Pressure.                                           Clinical Care.     18-85 years of age      Committee for
                                                                        who had a diagnosis     Quality
                                                                        of hypertension and     Assurance.
                                                                        whose blood pressure
                                                                        was adequately
                                                                        controlled (<140/90
                                                                        mmHg) during the
                                                                        measurement period.
Diabetes: Eye Exam............  0055/117..........  Effective          Percentage of patients  National
                                                     Clinical Care.     18-75 years of age      Committee for
                                                                        with diabetes who had   Quality
                                                                        a retinal or dilated    Assurance.
                                                                        eye exam by an eye
                                                                        care professional
                                                                        during the
                                                                        measurement period or
                                                                        a negative retinal
                                                                        exam (no evidence of
                                                                        retinopathy) in the
                                                                        12 months prior to
                                                                        the measurement
                                                                        period.
Diabetes: Hemoglobin A1c        0059/001..........  Effective          Percentage of patients  National
 (HbA1c) Poor Control (<9%).                         Clinical Care.     18-75 years of age      Committee for
                                                                        with diabetes who had   Quality
                                                                        hemoglobin A1c >9.0%    Assurance
                                                                        during the
                                                                        measurement period.
Use of High-Risk Medications    0022/238..........  Patient Safety...  Percentage of patients  National
 in the Elderly.                                                        66 years of age and     Committee for
                                                                        older who were          Quality
                                                                        ordered high-risk       Assurance.
                                                                        medications. Two
                                                                        rates are reported
                                                                       a. Percentage of
                                                                        patients who were
                                                                        ordered at least one
                                                                        high risk medication.
                                                                       b. Percentage of
                                                                        patients who were
                                                                        ordered at least two
                                                                        different high risk
                                                                        medications.
Dementia: Cognitive Assessment  2872/281..........  Effective          Percentage of           Physician
                                                     Clinical Care.     patients, regardless    Consortium for
                                                                        of age, with a          Performance
                                                                        diagnosis of dementia   Improvement
                                                                        for whom an             Foundation
                                                                        assessment of           (PCPI).
                                                                        cognition is
                                                                        performed and the
                                                                        results reviewed at
                                                                        least once within a
                                                                        12-month period.
Falls: Screening for Future     0101/318..........  Patient Safety...  (A) Screening for       National
 Fall Risk.                                                             Future Fall Risk:       Committee for
                                                                        Patients who were       Quality
                                                                        screened for future     Assurance.
                                                                        fall risk at least
                                                                        once within 12 months.
                                                                       (B) Multifactorial
                                                                        Falls Risk
                                                                        Assessment: Patients
                                                                        at risk of future
                                                                        fall who had a
                                                                        multifactorial risk
                                                                        assessment for falls
                                                                        completed within 12
                                                                        months.
                                                                       (C) Plan of Care to
                                                                        Prevent Future Falls:
                                                                        Patients at risk of
                                                                        future fall with a
                                                                        plan of care for
                                                                        falls prevention
                                                                        documented within 12
                                                                        months..
Initiation and Engagement of    0004/305..........  Effective          Percentage of patients  National
 Alcohol and Other Drug                              Clinical Care.     13 years of age and     Committee for
 Dependence Treatment.                                                  older with a new        Quality
                                                                        episode of alcohol      Assurance.
                                                                        and other drug (AOD)
                                                                        dependence who
                                                                        received the
                                                                        following. Two rates
                                                                        are reported
                                                                       a. Percentage of
                                                                        patients who
                                                                        initiated treatment
                                                                        within 14 days of the
                                                                        diagnosis..
                                                                       b. Percentage of
                                                                        patients who
                                                                        initiated treatment
                                                                        and who had two or
                                                                        more additional
                                                                        services with an AOD
                                                                        diagnosis within 30
                                                                        days of the
                                                                        initiation visit..
Closing the Referral Loop:      Not Applicable/374  Communication and  Percentage of Patients  Centers for
 Receipt of Specialist Report.                       Care               with referrals,         Medicare and
                                                     Coordination.      regardless of age,      Medicaid
                                                                        for which the           Services.
                                                                        referring provider
                                                                        receives a report
                                                                        from the provider to
                                                                        whom the patient was
                                                                        referred.
Cervical Cancer Screening.....  0032/309..........  Effective          Percentage of women 21- National
                                                     Clinical Care.     64 years of age, who    Committee for
                                                                        were screened for       Quality
                                                                        cervical cancer using   Assurance.
                                                                        either of the
                                                                        following criteria
                                                                        Women age 21-
                                                                        64 who had cervical
                                                                        cytology performed
                                                                        every 3 years.
                                                                        Women age 30-
                                                                        64 who had cervical
                                                                        cytology/human
                                                                        papillomavirus (HPV)
                                                                        co-testing performed
                                                                        every 5 years.
Colorectal Cancer Screening...  0034/113..........  Effective          Percentage of           National
                                                     Clinical Care.     patients, 50-75 years   Committee for
                                                                        of age who had          Quality
                                                                        appropriate screening   Assurance.
                                                                        for colorectal cancer.
Preventive Care and Screening:  0028/226..........  Community/         Percentage of patients  Physician
 Tobacco Use: Screening and                          Population         aged 18 years and       Consortium for
 Cessation Intervention.                             Health.            older who were          Performance
                                                                        screened for tobacco    Improvement
                                                                        use one or more times   Foundations
                                                                        within 24 months and    (PCPI).
                                                                        who received
                                                                        cessation counseling
                                                                        intervention if
                                                                        identified as a
                                                                        tobacco user.
Breast Cancer Screening.......  2372/112..........  Effective          Percentage of women 50- National
                                                     Clinical Care.     74 years of age who     Committee for
                                                                        had a mammogram to      Quality
                                                                        screen for breast       Assurance.
                                                                        cancer.

[[Page 53711]]

 
Preventive Care and Screening:  0041/110..........  Community/         Percentage of patients  Physician
 Influenza Immunization.                             Population         aged 6 months and       Consortium for
                                                     Health.            older seen for a        Performance
                                                                        visit between October   Improvement
                                                                        1 and March 31 who      Foundations
                                                                        received an influenza   PCPI(R)
                                                                        immunization OR who     Foundation
                                                                        reported previous       (PCPI[R]).
                                                                        receipt of an
                                                                        influenza
                                                                        immunization.
Pneumonia Vaccination Status    0043/111..........  Community/         Percentage of patients  National
 for Older Adults.                                   Population         65 years of age and     Committee for
                                                     Health.            older who have ever     Quality
                                                                        received a              Assurance.
                                                                        pneumococcal vaccine.
Diabetes: Medical Attention     0062/119..........  Effective          The percentage of       National
 for Nephropathy.                                    Clinical Care.     patients 18-75 years    Committee for
                                                                        of age with diabetes    Quality
                                                                        who had a nephropathy   Assurance.
                                                                        screening test or
                                                                        evidence of
                                                                        nephropathy during
                                                                        the measurement
                                                                        period.
Ischemic Vascular Disease       0068/204..........  Effective          Percentage of patients  National
 (IVD): Use of Aspirin or                            Clinical Care.     18 years of age and     Committee for
 Another.                                                               older who were          Quality
                                                                        diagnosed with acute    Assurance.
                                                                        myocardial infarction
                                                                        (AMI), coronary
                                                                        artery bypass graft
                                                                        (CABG) or
                                                                        percutaneous coronary
                                                                        interventions (PCI)
                                                                        in the 12 months
                                                                        prior to the
                                                                        measurement period,
                                                                        or who had an active
                                                                        diagnosis of ischemic
                                                                        vascular disease
                                                                        (IVD) during the
                                                                        measurement period,
                                                                        and who had
                                                                        documentation of use
                                                                        of aspirin or another
                                                                        antiplatelet during
                                                                        the measurement
                                                                        period.
Preventive Care and Screening:  0418/134..........  Community/         Percentage of patients  Centers for
 Screening for Depression and                        Population         aged 12 years and       Medicare &
 Follow-Up Plan.                                     Health.            older screened for      Medicaid
                                                                        depression on the       Services.
                                                                        date of the encounter
                                                                        using an age
                                                                        appropriate
                                                                        standardized
                                                                        depression screening
                                                                        tool AND if positive,
                                                                        a follow-up plan is
                                                                        documented on the
                                                                        date of the positive
                                                                        screen.
Statin Therapy for the          Not Applicable/438  Effective          Percentage of the       Centers for
 Prevention and Treatment of                         Clinical Care.     following patients--    Medicare &
 Cardiovascular Disease.                                                all considered at       Medicaid
                                                                        high risk of            Services.
                                                                        cardiovascular
                                                                        events--who were
                                                                        prescribed or were on
                                                                        statin therapy during
                                                                        the measurement
                                                                        period:
                                                                       * Adults aged >=21
                                                                        years who were
                                                                        previously diagnosed
                                                                        with or currently
                                                                        have an active
                                                                        diagnosis of clinical
                                                                        atherosclerotic
                                                                        cardiovascular
                                                                        disease (ASCVD); OR.
                                                                       * Adults aged >=21
                                                                        years who have ever
                                                                        had a fasting or
                                                                        direct low-density
                                                                        lipoprotein
                                                                        cholesterol (LDL-C)
                                                                        level >=190 mg/dL or
                                                                        were previously
                                                                        diagnosed with or
                                                                        currently have an
                                                                        active diagnosis of
                                                                        familial or pure
                                                                        hypercholesterolemia;
                                                                        OR.
                                                                       * Adults aged 40-75
                                                                        years with a
                                                                        diagnosis of diabetes
                                                                        with a fasting or
                                                                        direct LDL-C level of
                                                                        70-189 mg/dL.
Inpatient Hospital Utilization  Not Applicable....  Not Applicable...  For members 18 years    National
 (IHU).                                                                 of age and older, the   Committee for
                                                                        risk-adjusted ratio     Quality
                                                                        of observed to          Assurance.
                                                                        expected acute
                                                                        inpatient discharges
                                                                        during the
                                                                        measurement year
                                                                        reported by Surgery,
                                                                        Medicine, and Total.
Emergency Department            Not Applicable....  Not Applicable...  For members 18 years    National
 Utilization (EDU).                                                     of age and older, the   Committee for
                                                                        risk-adjusted ratio     Quality
                                                                        of observed to          Assurance.
                                                                        expected emergency
                                                                        department (ED)
                                                                        visits during the
                                                                        measurement year.
CAHPS.........................  CPC+ specific;      Person and         CG-CAHPS Survey 3.0...  Agency for
                                 different than      Caregiver-                                 Healthcare
                                 CAHPS for MIPS.     Centered                                   Research and
                                                     Experience and                             Quality.
                                                     Outcome.
----------------------------------------------------------------------------------------------------------------

7. MIPS Final Score Methodology
    For the 2020 MIPS payment year, we intend to build on the scoring 
methodology we finalized for the transition year, which allows for 
accountability and alignment across the performance categories and 
minimizes burden on MIPS eligible clinicians, while continuing to 
prepare MIPS eligible clinicians for the performance threshold required 
for the 2021 MIPS payment year. Our rationale for our scoring 
methodology continues to be grounded in the understanding that the MIPS 
scoring system has many components and numerous moving parts.
    As we continue to move forward in implementing the MIPS program, we 
strive to balance the statutory requirements and programmatic goals 
with the ease of use, stability, and meaningfulness for MIPS eligible 
clinicians, while also emphasizing simplicity and scoring that is 
understandable for MIPS eligible clinicians. We proposed refinements to 
the performance standards, the methodology for determining a score for 
each of the four performance categories (the ``performance category 
score''), and the methodology for determining a final score based on 
the performance category scores (82 FR 30140 through 30142).
    We intended to continue the transition of MIPS by proposing the 
following policies:
     Continuation of many transition year scoring policies in 
the quality performance category, with an adjustment to the number of 
achievement points available for measures that fail to meet the data 
completeness criteria, to encourage MIPS eligible clinicians to meet 
data completeness while providing an exception for small practices;
     An improvement scoring methodology that rewards MIPS 
eligible clinicians who improve their performance in the quality and 
cost performance categories;
     A new scoring option for the quality and cost performance 
categories that allows facility-based MIPS eligible clinicians to be 
scored based on their facility's performance;
     Special considerations for MIPS eligible clinicians in 
small practices or those who care for complex patients; and
     Policies that allow multiple pathways for MIPS eligible 
clinicians to receive a neutral to positive MIPS payment adjustment.

[[Page 53712]]

    We noted that these sets of proposed policies will help clinicians 
smoothly transition from the transition year to the 2021 MIPS payment 
year, for which the performance threshold (which represents the final 
score that would earn a neutral MIPS adjustment) would be either the 
mean or median (as selected by the Secretary) of the MIPS final scores 
for all MIPS eligible clinicians from a previous period specified by 
the Secretary.
    Unless otherwise noted, for purposes of this section II.C.7. of the 
final rule with comment period on scoring, the term ``MIPS eligible 
clinician'' will refer to MIPS eligible clinicians that submit data and 
are scored at either the individual- or group-level, including virtual 
groups, but will not refer to MIPS eligible clinicians who elect 
facility-based scoring. The scoring rules for facility-based 
measurement are discussed in section II.C.7.a.(4) of this final rule 
with comment period. We also note that the APM scoring standard applies 
to APM Entities in MIPS APMs, and those policies take precedence where 
applicable; however, where those policies do not apply, scoring for 
MIPS eligible clinicians as described in section II.C.7. of this final 
rule with comment period will apply. We refer readers to section 
II.C.6.g. of this final rule with comment period for additional 
information about the APM scoring standard.
a. Converting Measures and Activities Into Performance Category Scores
(1) Policies That Apply Across Multiple Performance Categories
    The policies for scoring the 4 performance categories are described 
in detail in section II.C.7.a. of this final rule with comment period. 
However, as the 4 performance categories collectively create a single 
MIPS final score, there are several policies that apply across 
categories, which we discuss in section II.C.7.a.(1) of this final rule 
with comment period.
(a) Performance Standards
    In accordance with section 1848(q)(3) of the Act, in the CY 2017 
Quality Payment Program final rule, we finalized performance standards 
for the four performance categories. We refer readers to the CY 2017 
Quality Payment Program final rule for a description of the performance 
standards against which measures and activities in the four performance 
categories are scored (81 FR 77271 through 77272).
    As discussed in the proposed rule (82 FR 30096 through 30098), we 
proposed to add an improvement scoring standard to the quality and cost 
performance categories starting with the 2020 MIPS payment year.
(b) Policies Related to Scoring Improvement
(i) Background
    In accordance with section 1848(q)(5)(D)(i) of the Act, beginning 
with the 2020 MIPS payment year, if data sufficient to measure 
improvement are available, the final score methodology shall take into 
account improvement of the MIPS eligible clinician in calculating the 
performance score for the quality and cost performance categories and 
may take into account improvement for the improvement activities and 
advancing care information performance categories. In addition, section 
1848(q)(3)(B) of the Act provides that the Secretary, in establishing 
performance standards for measures and activities for the MIPS 
performance categories, shall consider: Historical performance 
standards; improvement; and the opportunity for continued improvement. 
Section 1848(q)(5)(D)(ii) of the Act also provides that achievement may 
be weighted higher than improvement.
    In the CY 2017 Quality Payment Program final rule, we summarized 
public comments received on the proposed rule regarding potential ways 
to incorporate improvement into the scoring methodology moving forward, 
including approaches based on methodologies used in the Hospital VBP 
Program, the Shared Savings Program, and Medicare Advantage 5-star 
Ratings Program (81 FR 77306 through 77308). We did not finalize a 
policy at that time on this topic and indicated we would take comments 
into account in developing a proposal for future rulemaking.
    When considering the applicability of these programs to MIPS, we 
looked at the approach that was used to measure improvement for each of 
the programs and how improvement was incorporated into the overall 
scoring system. An approach that focuses on measure-level comparison 
enables a more granular assessment of improvement because performance 
on a specific measure can be considered and compared from year to year. 
All options that we considered last year use a standard set of measures 
that do not provide for choice of measures to assess performance; 
therefore, they are better structured to compare changes in performance 
based on the same measure from year to year. The aforementioned 
programs do not use a category-level approach; however, we believe that 
a category-level approach would provide a broader perspective, 
particularly in the absence of a standard set of measures, because it 
would allow for a more flexible approach that enables MIPS eligible 
clinicians to select measures and data submission mechanisms that can 
change from year to year and be more appropriate to their practice in a 
given year.
    We believe that both approaches are viable options for measuring 
improvement. Accordingly, we noted that we believe that an appropriate 
approach for measuring improvement for the quality performance category 
and the cost performance category should consider the unique 
characteristics of each performance category rather than necessarily 
applying a uniform approach across both performance categories. For the 
quality performance category, clinicians are offered a variety of 
different measures which can be submitted by different mechanisms, 
rather than a standard set of measures or a single data submission 
mechanism. For the cost performance category, however, clinicians are 
scored on the same set of cost measures to the extent each measure is 
applicable and available to them; clinicians cannot choose which cost 
measures they will be scored on. In addition, all of the cost measures 
are derived from administrative claims data with no additional 
submission required by the clinician.
    When considering the applicability of these programs to MIPS, we 
also considered how scoring improvement is incorporated into the 
overall scoring system, including when only achievement or improvement 
is incorporated into a final score or when improvement and achievement 
are both incorporated into a final score.
    We refer readers to the proposed rule (82 FR 30096 through 30098) 
where we considered how we might adapt for MIPS the various approaches 
used for scoring improvement under the Hospital VBP Program, Medicare 
Shared Savings Program, and Medicare Advantage 5-Star rating.
    We proposed two different approaches for scoring improvement from 
year to year. We proposed to measure improvement at the performance 
category level for the quality performance category score (82 FR 30113 
through 30114) and refer readers to section II.C.7.a.(2)(i) of this 
final rule with comment period for a summary of the comments we 
received and our responses. Because clinicians can elect the submission 
mechanisms and quality measures that are most

[[Page 53713]]

meaningful to their practice, and these choices can change from year to 
year, we want a flexible methodology that allows for improvement 
scoring even when the quality measures change. This is particularly 
important as we encourage MIPS eligible clinicians to move away from 
topped out measures and toward more outcome measures. We do not want 
the flexibility that is offered to MIPS eligible clinicians in the 
quality performance category to limit clinicians' ability to move 
towards outcome measures, or limit our ability to measure improvement. 
Our final policies for taking improvement into account as part of the 
quality performance category score are addressed in detail in sections 
II.C.7.a.(2)(i) and II.C.7.a.(2)(j) of this final rule with comment 
period.
    We noted our belief that there is reason to adopt a different 
methodology for scoring improvement for the cost performance category 
from that used for the quality performance category. In contrast to the 
quality performance category, for the cost performance category, MIPS 
eligible clinicians do not have a choice in measures or submission 
mechanisms; rather, all MIPS eligible clinicians are assessed on all 
measures based on the availability and applicability of the measure to 
their practice, and all measures are derived from administrative claims 
data. Therefore, for the cost performance category, we proposed to 
measure improvement at the measure level (82 FR 30121). We also noted 
that we are statutorily required to measure improvement for the cost 
performance category beginning with the second MIPS payment year if 
data sufficient to measure improvement is available. Because we had 
proposed to weight the cost performance category at zero percent for 
the 2018 MIPS performance period/2020 MIPS payment year (82 FR 30047 
through 30048), the improvement score for the cost performance category 
would not have affected the MIPS final score for the 2018 MIPS 
performance period/2020 MIPS payment year and would have been for 
informational purposes only. However, as discussed in section 
II.C.6.d.(2) of this final rule with comment period, we are adopting 
our alternative option to maintain a 10 percent weight for the cost 
performance category, and therefore, the cost improvement score will be 
reflected in the cost performance category percent score and the final 
score for the 2018 MIPS performance period/2020 MIPS payment year.
    We did not propose to score improvement in the improvement 
activities performance category or the advancing care information 
performance category at this time, though we may address improvement 
scoring for these performance categories in future rulemaking.
    We proposed to amend Sec.  414.1380(a)(1)(i) to add that 
improvement scoring is available for the quality performance category 
and for the cost performance category at Sec.  414.1380(a)(1)(ii) 
beginning with the 2020 MIPS payment year.
    We solicited public comment on our proposals to score improvement 
for the quality and cost performance categories starting with the 2020 
MIPS payment year.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: Several commenters supported CMS's proposal to score 
improvement for the quality and cost performance categories to 
recognize and reward improvement as well as achievement. A few 
commenters supported separate approaches for scoring improvement for 
the cost and quality performance categories because of the specific 
characteristics of each category. A few commenters recommended that CMS 
review the impact of these proposals after the first year of 
implementation and refine them as necessary to ensure that they achieve 
the intended goal of rewarding improvement and not penalizing high 
performers. One commenter supported the incorporation of improvement 
scoring because measuring changes in year-to-year performance could 
create strong incentives for clinicians to further improve upon the 
quality and value of care. One commenter believed that clinicians who 
make large gains in their performance could be rewarded and 
incentivized toward continuous quality improvement, even for the 
highest performers. One commenter believed that scoring improvement 
would help solo, small, and rural practices with administrative 
challenges by incentivizing and offsetting upfront costs of MIPS 
participation. One commenter believed that scoring improvement could 
boost the success of MIPS because it would improve the quality of care 
patients receive, reduce the inefficient use of care, increase the 
value of care provided, focus on an enhanced reward system relative to 
quality and cost as the primary measurements of care efficiency, and 
increase clinicians' incentive to drive improvements in the performance 
categories. Finally, one commenter recommended continued transparency 
for the improvement scoring methodology and calculations because 
clinicians should be able to understand their progress in improving 
outcomes.
    Response: We thank commenters for their support for scoring 
improvement for the quality and cost performance categories starting 
with the 2020 MIPS payment year. We will implement improvement scoring 
beginning with the 2020 MIPS payment year. We intend to evaluate the 
implementation of improvement scoring for the quality and cost 
performance categories to determine how the policies we establish in 
this final rule with comment period are affecting MIPS eligible 
clinicians, including high-performing clinicians. We intend to 
implement improvement scoring in a transparent manner and we will 
address any changes in improvement scoring through future rulemaking. 
Please refer to sections II.C.7.a.(2)(i) and II.C.7.a.(3)(a) of this 
final rule with comment period for details for our proposals, comments, 
and final policies related to the implementation of improvement scoring 
for the quality and cost performance categories, respectively.
    Comment: Several commenters did not support scoring improvement for 
the quality and cost performance categories because they believed it 
would add a layer of complexity for clinicians participating in the 
MIPS program. Several commenters did not support 2 separate methods for 
improvement scoring for quality and cost because this approach would 
lead to further complexity in the MIPS program. Several commenters 
recommended that CMS delay implementation of improvement scoring and 
that CMS seek feedback from stakeholders and analyze data further 
because making adjustments after implementation may be difficult. 
Commenters also believed that there had not been sufficient discussion 
with stakeholders about the challenges for certain specialties, sites 
of service, and other participants; that clinicians need more time to 
understand the reporting requirements; and that the program's measures 
should be stable prior to implementing improvement scoring.
    Response: We acknowledge the commenters' concerns with the 
complexity that scoring improvement adds to the calculation of the MIPS 
quality performance category score. We also acknowledge the commenters' 
concerns related to the challenges of improvement scoring for specific 
types of clinician practices, the amount of time to understand the 
reporting requirements, and the stability of the program's measures. 
Section 1848(q)(5)(D)(i) of the Act requires us to take into account 
improvement when

[[Page 53714]]

calculating the quality and cost performance category scores beginning 
with the 2020 MIPS payment year if data sufficient to measure 
improvement is available. We intend to develop additional educational 
materials to help explain improvement scoring. We also intend to 
monitor implementation of improvement scoring for the quality and cost 
performance categories and will address any changes to improvement 
scoring through future rulemaking. Please refer to sections 
II.C.7.a.(2)(i)(ii) and II.C.7.a.(3)(a)(i) of this final rule with 
comment period for more information about our proposal and discussion 
related to data sufficiency for the quality and cost performance 
categories. We continue to believe that the separate methodologies for 
the quality and cost performance categories are warranted given the 
unique characteristics of each performance category.
    Comment: One commenter recommended that, in future rulemaking, CMS 
advance an improvement score proposal for the improvement activities 
and advancing care information performance categories that aligns with 
the proposal set forth for the quality performance category to measure 
improvement at the category level.
    Response: We will address improvement scoring for the improvement 
activities and advancing care information performance categories, and 
alignment as appropriate, in future rulemaking.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to amend Sec.  414.1380(a)(1)(i) and Sec.  
414.1380(a)(1)(ii) to add that improvement scoring is available for the 
quality performance category and the cost performance category 
beginning with the 2020 MIPS payment year.
(ii) Data Sufficiency Standard To Measure Improvement
    Section 1848(q)(5)(D)(i) of the Act requires us to measure 
improvement for the quality and cost performance categories of MIPS if 
data sufficient to measure improvement are available, which we 
interpret to mean that we would measure improvement when we can 
identify data from a current performance period that can be compared to 
data from a prior performance period or data that compares performance 
from year to year. We proposed that we would measure improvement for 
the quality performance category when data is available because there 
is a performance category score for the prior performance period (82 FR 
30114 through 30116). We also proposed that we would measure 
improvement for the cost performance category when data is available 
which is when there is sufficient case volume to provide measurable 
data on measures in subsequent years with the same identifier (82 FR 
30121). We refer readers to sections II.C.7.a.(2)(i)(ii) and 
II.C.7.a.(3)(a)(i) of this final rule with comment period for details 
on these proposals, the comments received and our responses, and final 
policies.
(c) Scoring Flexibility for ICD-10 Measure Specification Changes During 
the Performance Period
    The quality and cost performance categories rely on measures that 
use detailed measure specifications that include ICD-10-CM/PCS (``ICD-
10'') code sets. We annually issue new ICD-10 coding updates, which are 
effective from October 1 through September 30 (https://www.cms.gov/Medicare/Coding/ICD10/ICD10OmbudsmanandICD10CoordinationCenterICC.html). As part of this 
update, codes are added as well as removed from the ICD-10 code set.
    To provide scoring flexibility for MIPS eligible clinicians and 
groups for measures impacted by ICD-10 coding changes in the final 
quarter of the Quality Payment Program performance period--which may 
render the measures no longer comparable to the historical benchmark--
we proposed in the CY 2018 Quality Payment Program proposed rule (82 FR 
30098) to codify at Sec. Sec.  414.1380(b)(1)(xviii) that we will 
assess performance on measures considered significantly impacted by 
ICD-10 updates based only on the first 9 months of the 12-month 
performance period (for example, January 1, 2018 through September 30, 
2018, for the 2018 MIPS performance period). As discussed in the CY 
2018 Quality Payment Program proposed rule (82 FR 30098), we believed 
it would be appropriate to assess performance for significantly 
impacted measures based on the first 9 months of the performance 
period, rather than the full 12 months because the indicated 
performance for the last quarter could be affected by the coding 
changes rather than actual differences in performance. We noted that 
performance on measures that are not significantly impacted by changes 
to ICD-10 codes would continue to be assessed on the full 12-month 
performance period (January 1 through December 31) (82 FR 30098).
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30098), 
we noted that any measure that relies on an ICD-10 code which is added, 
modified, or removed, such as in the measure numerator, denominator, 
exclusions, or exceptions, could have an impact on the indicated 
performance on the measure, although the impact may not always be 
significant. In the CY 2018 Quality Payment Program proposed rule, we 
proposed an annual review process to analyze the measures that have a 
code impact and assess the subset of measures significantly impacted by 
ICD-10 coding changes during the performance period (82 FR 30098). 
Depending on the data available, we anticipated that our determination 
as to whether a measure is significantly impacted by ICD-10 coding 
changes would include these factors: A more than 10 percent change in 
codes in the measure numerator, denominator, exclusions, and 
exceptions; clinical guideline changes or new products or procedures 
reflected in ICD-10 code changes; and feedback on a measure received 
from measure developers and stewards (82 FR 30098). In the CY 2018 
Quality Payment Program proposed rule, we considered an approach where 
we would consider any change in ICD-10 coding to impact performance on 
a measure and thus only rely on the first 9 months of the 12-month 
performance period for such measures; however, we believed such an 
approach would be too broad and truncate measurement for too many 
measures where performance may not be significantly affected (82 FR 
30098). We believed that our proposed approach would ensure the 
measures on which individual MIPS eligible clinicians and groups will 
have their performance assessed are accurate for the performance period 
and are consistent with the benchmark set for the performance period 
(82 FR 30098).
    We proposed to publish on the CMS Web site which measures are 
significantly impacted by ICD-10 coding changes and would require the 
9-month assessment (82 FR 30098). We proposed to publish this 
information by October 1st of the performance period if technically 
feasible, but by no later than the beginning of the data submission 
period, which is January 2, 2019 for the 2018 MIPS performance period 
(82 FR 30098).
    We requested comment on the proposal to address ICD-10 measures 
specification changes during the performance period by relying on the 
first 9 months of the 12-month performance period (82 FR 30098). We 
also requested comment on potential alternate approaches to address 
measures that are significantly impacted due to ICD-10 changes during 
the performance period, including the factors we might use to determine

[[Page 53715]]

whether a measure is significantly impacted (82 FR 30098).
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: A few commenters had suggestions to improve the proposed 
ICD-10 annual review process. Some commenters suggested that CMS 
develop a centralized process for soliciting feedback on measures that 
may be significantly impacted by ICD-10 coding changes and facilitate 
discussions between measure developers, stewards, clinicians, and 
vendors who would be implementing the changes to resolve ICD-10 coding 
changes as quickly as possible. A few commenters also recommended that 
CMS address significant changes as a result of ICD-10 changes through 
notice and comment rulemaking.
    Response: We will take commenters' suggestions for a centralized 
process for soliciting feedback on significantly impacted measures and 
facilitating discussions into consideration as part of our annual 
review process. We are finalizing our proposal to assess measure 
performance based only on the first 9 months of the 12-month 
performance period when we determine that a measure is significantly 
impacted by ICD-10 coding changes. Measures impacted by ICD-10 coding 
changes will be identified during the performance period. We are unable 
to address each individual ICD-10 code change through rulemaking in 
advance as the code changes are identified during the performance 
period and take effect on October 1 of the performance period. However, 
any changes to this policy, including our process for identifying 
significantly impacted measures, and any substantive changes to quality 
or cost measures will be addressed through future rulemaking. We are 
also finalizing our proposal to publish which measures are 
significantly impacted by ICD-10 coding changes by October 1st of the 
performance period if technically feasible, but by no later than the 
beginning of the data submission period, which is January 2, 2019 for 
the 2018 MIPS performance period. We will also provide further 
information through subregulatory guidance.
    Comment: Several commenters were supportive of the proposal to 
score measures that are considered significantly impacted by ICD-10 
updates based on only the first 9 months of the performance period to 
align with annual ICD-10 updates.
    Response: We thank commenters for their support. We are finalizing 
our proposal to assess measure performance based only on the first 9 
months of the 12-month performance period when we determine measures 
are significantly impacted by ICD-10 coding changes. Our determination 
as to whether a measure is significantly impacted by ICD-10 coding 
changes will consider one or more of the following factors: A more than 
10 percent change in codes in the measure numerator, denominator, 
exclusions, and exceptions; guideline changes or new products or 
procedures reflected in ICD-10 code changes; and feedback on a measure 
received from measure developers and stewards.
    Comment: Several commenters expressed concern about our proposed 
approach to scoring flexibility based on the impact of the ICD-10 
update cycle on measures and suggested alternatives. The commenters 
noted that because it is possible for ICD-10 updates to occur in April 
as well as in October, CMS's proposal does not solve the issue of ICD-
10 updates that occur midway through the performance period. A few 
commenters recommended that CMS give full credit for reporting that 
would be applied in future years, or alternatively, that CMS consider 
novel approaches that developers, stewards, and implementers may have 
for accounting for ICD-10 changes--for example, releasing new measure 
guidance or suspending the use of certain new ICD-10 codes until the 
following performance period.
    Response: While the list of ICD-10 codes are available prior to 
October 1, for Medicare Part A and Part B, all ICD-10 changes become 
effective October 1. As discussed further below, we are finalizing our 
proposal to measure the first 9 months of the performance period when 
we determine measures are significantly impacted by ICD-10 updates. We 
believe this approach ensures our assessment of performance will only 
be based on measures with ICD-10 codes and measure specifications that 
are consistent with the historical benchmark we set out for the 
performance period when available, which are relied on by MIPS eligible 
clinicians and groups as they plan for the performance period. While we 
acknowledge the other approaches recommended by commenters, such as 
providing full credit for reporting that would be applied in future 
years, we believe the approach we are finalizing allows comparisons to 
historical benchmarks, which use similar codes, and ensures the measure 
specifications are accurate for the time period being measured. As some 
commenters suggested, the input of stakeholders in this process is 
valuable, and we will consider the input of developers, stewards and 
implementers as part of the annual review process. More information 
will be available through subregulatory guidance.
    Comment: Several commenters expressed concern that for certain 
measures, truncated reporting would not be appropriate due to their 
measure logic, and the measures would be negatively impacted by a 
shorter reporting window since it can take a full year to capture the 
data needed to successfully report these measures. One commenter 
expressed concern that, because certain standards used by registries to 
support measure reporting do not include timing information, such as 
the QRDA III standard, it is unclear how MIPS eligible clinicians would 
be able to submit only 9 months of data. This commenter urged CMS to, 
instead, adjust the value sets to account for the updates and have 
those changes apply to the entire performance year, with no change to 
full-year measure submission. This commenter suggested that this would 
allow clinicians to take immediate advantage of critical updates to 
value sets without having to wait until the next performance year. The 
commenters also noted that the very short timeline between the 
discovery and announcement of the error and the end of the submission 
period would place an unreasonable burden on MIPS eligible clinicians 
to revise and revalidate their submissions. One commenter also noted 
that CMS's approach adds complexity because clinicians and groups would 
have to track which measures require a full year of reporting and which 
require only 9 months.
    Response: We acknowledge the commenters' concerns that scoring 
based on only 9 months of data raises issues with assessing MIPS 
eligible clinicians and groups on less than a full year of data, 
particularly for some measures. We also acknowledge that certain 
standards used by registries to support measure reporting do not 
include timing information. In response to these concerns we note that 
where, as part of our annual review process we determine that scoring a 
significantly impacted measure based on only 9 months of data is 
inappropriate due to the measure logic or other factors, we will 
communicate with MIPS eligible clinicians and groups and interested 
parties and provide information to them through subregulatory guidance. 
However, we expect that these instances would be rare based on our 
experience.
    We also acknowledge the concerns raised by commenters about the 
burden MIPS eligible clinicians may face to revise and revalidate their 
submissions,

[[Page 53716]]

and clarify that CMS will monitor ICD-10 updates and coding changes 
that significantly impact measures during the performance period to 
track which measures require a full year of reporting and which require 
only 9 months, and we will also provide this information to MIPS 
eligible clinicians, groups, and other interested parties, including 
registries, through subregulatory guidance. We acknowledge the 
commenter's suggestion that, alternatively, we adjust the value sets to 
account for the updates and have those changes apply to the entire 
performance year, with no change to full-year measure submission; 
however, this approach is not operationally feasible for us to 
implement.
    Comment: One commenter did not support the approach that CMS 
considered but rejected, whereby CMS would consider any change in ICD-
10 coding to impact performance on a measure, and thus, rely on the 
first 9 months of the 12-month performance period for such measures.
    Response: We acknowledge that such an approach would be too broad 
and truncate measurement for too many measures where performance may 
not be significantly affected and have rejected this approach.
    Comment: Several commenters supported the proposal to publish the 
measures significantly impacted by ICD-10 coding changes that would 
require the 9-month assessment, and agreed with the factors listed to 
consider in determining whether a measure is significantly impacted by 
an ICD-10 coding update.
    Response: We thank the commenters for their support. We are 
finalizing as proposed our proposal to publish the list of measures 
requiring a 9-month assessment process on the CMS Web site by October 
1st of the performance period if technically feasible, but by no later 
than the beginning of the data submission period. For example, for the 
2018 performance period, data submissions will begin on January 2, 
2019.
    Comment: Several commenters requested that CMS provide information 
about significantly impacted measures as soon as possible. The 
commenters suggested that CMS issue the impacted ICD-10 list well 
before October 1 to allow clinician and groups to appropriately prepare 
for the upcoming submission cycle. A few commenters recommended that 
clinicians and groups will need a 30- to 60-day window of lead time, 
such as November 1 or December 1.
    Response: We acknowledge that it would be useful to identify 
significantly impacted measures as early as possible and will take 
commenters' concerns into consideration to identify and publish 
information on impacted measures as soon as it is technically feasible 
for us to do so. We are finalizing that we will publish this 
information by October 1st of the performance period if technically 
feasible, but by no later than the beginning of the data submission 
period, which is January 2, 2019 for the 2018 MIPS performance period. 
We believe this timeline provides us needed time to review whether ICD-
10 code changes are significant or not as well as reviewing other 
guideline changes.
    Comment: Some commenters recommended that CMS include how the 
annual ICD-10 update on October 1 may impact quality measures, 
performance scores, and benchmarks for the last quarter of the year 
because this is vital information needed for clinicians and groups to 
make informed decisions about the performance period best suited for 
their practice, including those who may want to choose the last 90 days 
of 2018 as their performance period for the advancing care information 
and the improvement activities performance categories, which have 90-
day performance periods.
    Response: We will consider commenters' suggestions about the 
information to include regarding significantly impacted measures as we 
prepare our publication of significantly impacted measures. We will 
monitor measure changes as they occur and rely on stakeholder input; we 
will also provide subregulatory communication and guidance to 
stakeholders as to how changes we determine to be significant may 
impact the quality measures, performance scores, and benchmarks. We do 
not believe this policy will affect the improvement activities and 
advancing care information performance categories because those 
performance categories have a 90-day reporting period.
    Final Action: After consideration of the public comments, we are 
finalizing as proposed our policy to provide scoring flexibility for 
ICD-10 measure specification changes during the performance period. We 
are finalizing that we will establish an annual review process to 
analyze the measures that have a code impact and assess the subset of 
measures significantly impacted by ICD-10 coding changes during the 
performance period. Depending on the data available, our determination 
as to whether a measure is significantly impacted by ICD-10 coding 
changes will include one or more these factors: A more than 10 percent 
change in codes in the measure numerator, denominator, exclusions, and 
exceptions; clinical guideline changes or new products or procedures 
reflected in ICD-10 code changes; and feedback on a measure received 
from measure developers and stewards. Beginning with the 2018 MIPS 
performance period, measures we determine to be significantly impacted 
by ICD-10 updates will be assessed based only on the first 9 months of 
the 12-month performance period. Lastly, we are finalizing as proposed 
that we will publish the list of measures requiring a 9-month 
assessment process on the CMS Web site by October 1st of the 
performance period if technically feasible, but by no later than the 
beginning of the data submission period, which is January 2, 2019 for 
the 2018 MIPS performance period, as discussed in section II.C.6.a.(2) 
of this final rule with comment period. We are codifying these policies 
for the quality performance category at Sec.  414.1380(b)(1)(xviii) in 
this final rule with comment period. As discussed in section 
II.C.6.d.(3)(d) of this final rule with comment period, we will apply a 
similar approach for measures in the cost performance category, 
although we do not anticipate that the cost measures for the 2018 MIPS 
performance period (total per capita cost measure and the MSPB) would 
be significantly affected by ICD-10 changes.
    As we finalize this policy for measures significantly impacted by 
ICD-10 code changes, we are also concerned about instances where 
clinical guideline changes or other changes to a measure that occur 
during the performance period may significantly impact a measure and 
render the measure no longer comparable to the historical benchmark. As 
such, we seek comment in this final rule with comment period regarding 
whether we should apply similar scoring flexibility to such measures.
(2) Scoring the Quality Performance Category for Data Submission via 
Claims, EHR, Third Party Data Submission Options, CMS Web Interface, 
and Administrative Claims
    Many comments submitted in response to the CY 2017 Quality Payment 
Program final rule requested additional clarification on our finalized 
scoring methodology for the 2019 MIPS payment year. To provide further 
clarity to MIPS eligible clinicians about the transition year scoring 
policies, before describing our proposed scoring policies for the 2020 
MIPS payment year, we provided a summary of the scoring policies 
finalized in the CY 2017 Quality Payment Program final rule

[[Page 53717]]

along with examples of how they apply under several scenarios (82 FR 
30098 through 30100).
    In the CY 2017 Quality Payment Program final rule (81 FR 77286 
through 77287), we finalized that the quality performance category 
would be scored by assigning achievement points to each submitted 
measure, which we refer to in this section of the proposed rule as 
``measure achievement points.'' In the CY 2018 Quality Payment Program 
proposed rule (82 FR 30098 through 30099), we proposed to amend various 
paragraphs in Sec.  414.1380(b)(1) to use this term in place of 
``achievement points.'' MIPS eligible clinicians can also earn bonus 
points for certain measures (81 FR 77293 through 77294; 81 FR 77297 
through 77299), which we referred to as ``measure bonus points,'' and 
we proposed to amend Sec.  414.1380(b)(1)(xiii) (which we proposed to 
redesignate as Sec.  414.1380(b)(1)(xiv) \3\), Sec.  
414.1380(b)(1)(xiv) (which we proposed to redesignate as Sec.  
414.1380(b)(1)(xv)), and Sec.  414.1380(b)(1)(xv) (which we proposed to 
redesignate as Sec.  414.1380(b)(1)(xvii)) to use this term in place of 
``bonus points.'' The measure achievement points assigned to each 
measure would be added with any measure bonus points and then divided 
by the total possible points (Sec.  414.1380(b)(1)(xv) (which we 
proposed to redesignate as Sec.  414.1380(b)(1)(xvii)). We referred to 
the total possible points as ``total available measure achievement 
points,'' and we proposed to amend Sec.  414.1380(b)(1)(xv) to use this 
term in place of ``total possible points.'' We also proposed to amend 
these terms in Sec.  414.1380(b)(1)(xiii)(D) (which we proposed to 
redesignate as Sec.  414.1380(b)(1)(xiv)(D)), and Sec.  
414.1380(b)(1)(xiv) (which we proposed to redesignate as Sec.  
414.1380(b)(1)(xv)).
---------------------------------------------------------------------------

    \3\ In section II.C.7.a.(2)(c) of this final rule with comment 
period, we are finalizing a new provision to be codified at Sec.  
414.1380(b)(1)(xiii), and in section II.C.7.a.(2)(i) of this final 
rule with comment period, we are finalizing a new provision to be 
codified at Sec.  414.1380(b)(1)(xvi). As a result, we are 
finalizing as well that the remaining paragraphs be redesignated in 
order following the new provisions.
---------------------------------------------------------------------------

    This resulting quality performance category score is a fraction 
from zero to 1, which can be formatted as a percent; therefore, for 
this section, we will present the quality performance category score as 
a percent and refer to it as ``quality performance category percent 
score.'' We also proposed to amend Sec.  414.1380(b)(1)(xv) (which we 
proposed to redesignate as Sec.  414.1380(b)(1)(xvii)) to use this term 
in place of ``quality performance category score.'' Thus, the formula 
for the quality performance category percent score that we will use in 
this section is as follows:

(Total measure achievement points + total measure bonus points)/total 
available measure achievement points = quality performance category 
percent score.

    This is a summary of the public comments received on the changes to 
the regulatory text and our responses:
    Comment: One commenter expressed their belief that the continued 
changes in terminology not based on statute serves to confuse 
clinicians and further complicate the Quality Payment Program.
    Response: The amendments to the regulatory text are meant to 
clarify our terminology to make the Quality Payment Program easier to 
understand. The changes to terminology are not intended to create 
confusion but to respond to feedback on the need for more clarity and 
meaningful terms than those used in the Act. These amendments to 
regulation text are not changes to the program policy.
    Final Action: After consideration of public comments, we are 
finalizing the proposed clarifications and redesignations in Sec.  
414.1380(b)(1) related to measure achievement points and the quality 
performance category score.
    In the CY 2017 Quality Payment Program final rule, we finalized 
that for the quality performance category, an individual MIPS eligible 
clinician or group that submits data on quality measures via EHR, QCDR, 
qualified registry, claims, or a CMS-approved survey vendor for the 
CAHPS for MIPS survey will be assigned measure achievement points for 6 
measures (1 outcome or, if an outcome measure is not available, other 
high priority measure and the next 5 highest scoring measures) as 
available and applicable, and will receive applicable measure bonus 
points for all measures submitted that meet the bonus criteria (81 FR 
77282 through 77301).
    In addition, for groups of 16 or more clinicians who meet the case 
minimum of 200, we will also automatically score the administrative 
claims-based all-cause hospital readmission measure as a seventh 
measure (81 FR 77287). For individual MIPS eligible clinicians and 
groups for whom the readmission measure does not apply, the denominator 
is generally 60 (10 available measure achievement points multiplied by 
6 available measures). For groups for whom the readmission measure 
applies, the denominator is generally 70 points.
    If we determined that a MIPS eligible clinician has fewer than 6 
measures available and applicable, we will score only the number of 
measures that are available and adjust the denominator accordingly to 
the total available measure achievement points (81 FR 77291). A 
description of the validation process to determine measure availability 
is provided in the proposed rule (82 FR 30108 through 30109).
    For the 2019 MIPS payment year, a MIPS eligible clinician that 
submits quality measure data via claims, EHR, or third party data 
submission options (that is, QCDR, qualified registry, EHR, or CMS-
approved survey vendor for the CAHPS for MIPS survey), can earn between 
3 and 10 measure achievement points for quality measures submitted for 
the performance period of greater than or equal to 90 continuous days 
during CY 2017. A MIPS eligible clinician can earn measure bonus points 
(subject to a cap) if they submit additional high priority measures 
with a performance rate that is greater than zero, and that meet the 
case minimum and data completeness requirements, or submit a measure 
using an end-to-end electronic pathway. An individual MIPS eligible 
clinician that has 6 or more quality measures available and applicable 
will have 60 total available measure achievement points. An example was 
provided in Table 17 of the proposed rule (82 FR 30099). We noted that 
in the CY 2017 Quality Payment Program proposed rule, we proposed that 
bonus points would be available for high priority measures that are not 
scored (not included in the top 6 measures for the quality performance 
category score) as long as the measure has the required case minimum, 
data completeness, and has a performance rate greater than zero, 
because we believed these qualities would allow us to include the 
measure in future benchmark development (81 FR 28255). Although we 
received public comments on this policy, responded to those comments, 
and reiterated this proposal in the CY 2017 Quality Payment Program 
final rule (81 FR 77292), we would like to clarify that our policy is 
to assign measure bonus points for high priority measures, even if the 
measure's achievement points are not included in the total measure 
achievement points for calculating the quality performance category 
percent score, as long as the measure has the required case minimum, 
data completeness, and has a performance rate greater than zero, and

[[Page 53718]]

that this applies beginning with the transition year.
    We proposed to amend Sec.  414.1380(b)(1)(xiii)(A) (which we 
proposed to redesignate as Sec.  414.1380(b)(1)(xiv)(A)) to state that 
measure bonus points may be included in the calculation of the quality 
performance category percent score regardless of whether the measure is 
included in the calculation of the total measure achievement points. We 
also proposed a technical correction to the second sentence of that 
paragraph to state that to qualify for high priority measure bonus 
points, each measure must be reported with sufficient case volume to 
meet the required case minimum, meet the required data completeness 
criteria, and not have a zero percent performance rate.
    We did not receive any public comments on this proposal.
    Final Action: We are finalizing as proposed the amendments and 
technical corrections to Sec.  414.1380(b)(1) related to high priority 
measure bonus points.
    In the CY 2017 Quality Payment Program final rule, we also 
finalized scoring policies specific to groups of 25 or more that submit 
their quality performance measures using the CMS Web Interface (81 FR 
77278 through 77306). Although we did not propose to change the basic 
scoring system that we finalized in the CY 2017 Quality Payment Program 
final rule for the 2020 MIPS payment year, we noted that we proposed 
several modifications to scoring the quality performance category, 
including adjusting scoring for measures that do not meet the data 
completeness criteria, adding a method for scoring measures submitted 
via multiple mechanisms, adding a method for scoring selected topped 
out measures, and adding a method for scoring improvement (82 FR 
30100). We also noted that we proposed an additional option for 
facility-based scoring for the quality performance category (82 FR 
30123 through 30132). Further description of these proposals and 
finalized policies are discussed below.
(a) Quality Measure Benchmarks
    We did not propose to change the policies on benchmarking finalized 
in the CY 2017 Quality Payment Program final rule and codified at 
paragraphs (b)(1)(i) through (iii) of Sec.  414.1380; however, we 
proposed a technical correction to paragraphs (i) and (ii) to clarify 
that measure benchmark data are separated into decile categories based 
on percentile distribution, and that, other than using performance 
period data, performance period benchmarks are created in the same 
manner as historical benchmarks using decile categories based on a 
percentile distribution and that each benchmark must have a minimum of 
20 individual clinicians or groups who reported on the measure meeting 
the data completeness requirement and case minimum case size criteria 
and performance greater than zero. We referred readers to the 
discussion at 81 FR 77282 for more details on that policy.
    We received no public comments on the proposed technical correction 
to Sec.  414.1380.
    Final Action: We are finalizing the technical corrections to Sec.  
414.1380(b)(1)(i) through (iii) related to the measure benchmark data 
as proposed.
    We noted that the proposal to increase the low-volume threshold 
could have an impact on our MIPS benchmarks because we include MIPS 
eligible clinicians and comparable APMs that meet our benchmark 
criteria in our measure benchmarks, which could reduce the number of 
individual eligible clinicians and groups that meet the definition of a 
MIPS eligible clinician and contribute to our benchmarks (82 FR 30101). 
Therefore, we sought feedback on whether we should broaden the criteria 
for creating our MIPS benchmarks to include PQRS and any data from 
MIPS, including voluntary reporters, that meet our benchmark 
performance, case minimum and data completeness criteria when creating 
our benchmarks.
    We thank commenters for their responses on whether we should 
broaden the criteria for creating our MIPS benchmarks. We will consider 
them in future rulemaking.
    In the CY 2017 Quality Payment Program final rule, we did not 
stratify benchmarks by practice characteristics, such as practice size, 
because we did not believe there was a compelling rationale for such an 
approach, and we believed that stratifying could have unintended 
negative consequences for the stability of the benchmarks, equity 
across practices, and quality of care for beneficiaries (81 FR 77282). 
We noted that we do create separate benchmarks for each of the 
following submission mechanisms: EHR submission options; QCDR and 
qualified registry submission options; claims submission options; CMS 
Web Interface submission options; CMS-approved survey vendor for CAHPS 
for MIPS submission options; and administrative claims submission 
options (for measures derived from claims data, such as the all-cause 
hospital readmission measure) (81 FR 77282). We refer readers to the CY 
2018 Quality Payment Program proposed rule for a summary of the 
comments we received (82 FR 30101).
    We did not propose to change our policies related to stratifying 
benchmarks by practice size for the 2020 MIPS payment year. For many 
measures, the benchmarks may not need stratification as they are only 
meaningful to certain specialties and only expected to be submitted by 
those certain specialists. We further clarified that in the majority of 
instances our current benchmarking approach only compares like 
clinicians to like clinicians. We noted that we continue to believe 
that stratifying by practice size could have unintended negative 
consequences for the stability of the benchmarks, equity across 
practices, and quality of care for beneficiaries. However, we sought 
comment on methods by which we could stratify benchmarks, while 
maintaining reliability and stability of the benchmarks, to use in 
developing future rulemaking for future performance and payment years. 
Specifically, we sought comment on methods for stratifying benchmarks 
by specialty or by place of service. We also requested comment on 
specific criteria to consider for stratifying measures, such as how we 
should stratify submissions by multi-specialty practices or by 
practices that operate in multiple places of service.
    We thank commenters for their suggestions on stratifying benchmarks 
and measures for creating MIPS benchmarks. We will consider them in 
future rulemaking.
    When we were developing the quality measure benchmarks, we were 
guided by the principles we used when developing the MIPS unified 
scoring system (81 FR 28249 through 28250). We sought a system that 
enables MIPS eligible clinicians, beneficiaries, and stakeholders to 
understand what is required for a strong performance in MIPS while 
being consistent with statutory requirements. We also wanted the 
methodology to be as a simple as possible while providing flexibility 
for the variety of practice types. Now that we have gone through 1 year 
of the program, we are asking for comments on how we can improve our 
quality measure benchmarking methodology. In the CY 2018 Quality 
Payment Program proposed rule, we requested comments on how we can 
specifically improve our benchmarking methodology (82 FR 30100 through 
30101). For this final rule with comment period, we are requesting 
comments on whether our methodology has been successful in achieving 
the goals we aimed to achieve, and, if not,

[[Page 53719]]

what other ways or approaches we could use that are in line with 
principles we discussed above.
(b) Assigning Points Based on Achievement
    In the CY 2017 Quality Payment Program final rule, we finalized at 
Sec.  414.1380(b)(1) that a MIPS quality measure must have a measure 
benchmark to be scored based on performance. MIPS quality measures that 
do not have a benchmark (for example, because fewer than 20 MIPS 
eligible clinicians or groups submitted data that met our criteria to 
create a reliable benchmark) will not be scored based on performance 
(81 FR 77286). In the CY 2018 Quality Payment Program proposed rule (82 
FR 30101), we did not propose any changes to this policy. We did, 
however, propose a technical correction to the regulatory text at Sec.  
414.1380(b)(1) to delete the term ``MIPS'' before ``quality measure'' 
in the third sentence of that paragraph and to delete the term MIPS 
before ``quality measures'' in the fourth sentence of that paragraph 
because this policy applies to all quality measures, including the 
measures finalized for the MIPS program and the quality measures 
submitted through a QCDR that have been approved for MIPS.
    We also did not propose to change the policies to score quality 
measure performance using a percentile distribution, separated by 
decile categories and assign partial points based on the percentile 
distribution finalized in the CY 2017 Quality Payment Program final 
rule and codified at paragraphs (b)(1)(ix), (x), and (xi) of Sec.  
414.1380; however, we proposed a technical correction to paragraph (ix) 
to clarify that measures are scored against measure benchmarks. We 
referred readers to the discussion at 81 FR 77286 for more details on 
those policies.
    In Table 19 of the proposed rule (82 FR 3010), we provided an 
example of assigning points for performance based on benchmarks using a 
percentile distribution, separated by decile categories. We noted that 
for quality measures for which baseline period data is available, we 
will publish the numerical baseline period benchmarks with deciles 
prior to the start of the performance period (or as soon as possible 
thereafter) (see 81 FR 77282). For quality measures for which there is 
no comparable data from the baseline period, we will publish the 
numerical performance period benchmarks after the end of the 
performance period (81 FR 77282). We will also publish further 
explanation of how we calculate partial points at qpp.cms.gov.
    We did not receive public comments on this proposal.
    Final Action: We are finalizing as proposed the technical 
corrections to Sec.  414.1380(b)(1) related to quality measures.
(i) Floor for Scored Quality Measures
    For the 2017 MIPS performance period, we also finalized at Sec.  
414.1380(b)(1) a global 3-point floor for each scored quality measure, 
as well as for the hospital readmission measure (if applicable), such 
that MIPS eligible clinicians would receive between 3 and 10 measure 
achievement points for each submitted measure that can be reliably 
scored against a benchmark, which requires meeting the case minimum and 
data completeness requirements (81 FR 77286 through 77287). For 
measures with a benchmark based on the performance period, rather than 
on the baseline period, we stated that we would continue to assign 
between 3 and 10 measure achievement points for performance years after 
the first transition year because it would help to ensure that the MIPS 
eligible clinicians are protected from a poor performance score that 
they would not be able to anticipate (81 FR 77282; 81 FR 77287). For 
measures with benchmarks based on the baseline period, we stated the 3-
point floor was for the transition year and that we would revisit the 
3-point floor in future years (81 FR 77286 through 77287).
    We note, for clarification purposes, that we stated in the CY 2018 
Quality Payment Program proposed rule (82 FR 30102) that measures 
without a benchmark based on the baseline period would be assigned 
between 3 and 10 measure achievement points for performance years after 
the first transition year. However, we wanted to clarify that only 
measures without a benchmark based on the baseline period that later 
have a benchmark based on the performance period would be assigned 
between 3 and 10 measure achievement points for performance years after 
the first transition year. Measures without a benchmark based on the 
baseline or performance period would receive 3 points.
    For the 2018 MIPS performance period, we proposed to again apply a 
3-point floor for each measure that can be reliably scored against a 
benchmark based on the baseline period, and to amend Sec.  
414.1380(b)(1) accordingly. We noted that we proposed to score measures 
in the CMS Web Interface for the Quality Payment Program for which 
performance is below the 30th percentile (82 FR 30113). We will revisit 
the 3-point floor for such measures again in future rulemaking.
    We invited public comment on this proposal to again apply this 3-
point floor for quality measures that can be reliably scored against a 
baseline benchmark in the 2018 MIPS performance period.
    The following is a summary of the public comments received on the 
floor for quality measures proposal and our responses:
    Comment: Several commenters supported maintaining the 3-point floor 
for measures that can be reliably scored against a benchmark. A few 
commenters supported the policy because the 3-point floor maintains 
stability and rewards participation in the Quality Payment Program. One 
commenter indicated that this will allow time for eligible clinicians 
and groups to receive feedback on performance and incorporate changes 
into clinical practice.
    Response: We thank commenters for their support of the 3-point 
floor for the 2018 MIPS performance period and will finalize this 
policy as proposed.
    Comment: One commenter recommended that CMS should lower the 3-
point floor for measures reliably scored against a baseline benchmark, 
citing the need to move past transition year policies in the second 
year.
    Response: The 3-point floor in the 2018 performance period affords 
MIPS eligible clinicians the ability to continue to successfully 
transition into the program and provides stability and consistency in 
the Quality Payment Program. We will revisit this policy in future 
years.
    Final Action: After consideration of public comments, we are 
finalizing the proposal to again apply the 3-point floor for quality 
measures that can be reliably scored against a baseline benchmark in 
the 2018 MIPS performance period and to amend Sec.  414.1380(b)(1) 
accordingly.
(ii) Additional Policies for the CAHPS for MIPS Measure Score
    In the CY 2017 Quality Payment Program final rule, we finalized a 
policy for the CAHPS for MIPS measure, such that each Summary Survey 
Measure (SSM) will have an individual benchmark, that we will score 
each SSM individually and compare it against the benchmark to establish 
the number of points, and the CAHPS score will be the average number of 
points across SSMs (81 FR 77284).
    As described in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30102), we proposed to remove two SSMs from the CAHPS for MIPS 
survey, which would result in the collection of

[[Page 53720]]

10 SSMs in the CAHPS for MIPS survey. Eight of those 10 SSMs have had 
high reliability for scoring in prior years, or reliability is expected 
to improve for the revised version of the measure, and they also 
represent elements of patient experience for which we can measure the 
effect one practice has compared to other practices participating in 
MIPS. The ``Health Status and Functional Status'' SSM, however, 
assesses underlying characteristics of a group's patient population 
characteristics and is less of a reflection of patient experience of 
care with the group. Moreover, to the extent that health and functional 
status reflects experience with the practice, case-mix adjustment is 
not sufficient to separate how much of the score is due to patient 
experience versus due to aspects of the underlying health of patients. 
The ``Access to Specialists'' SSM has low reliability; historically it 
has had small sample sizes, and therefore, the majority of groups do 
not achieve adequate reliability, which means there is limited ability 
to distinguish between practices' performance.
    For these reasons, we proposed not to score the ``Health Status and 
Functional Status'' SSM and the ``Access to Specialists'' SSM beginning 
with the 2018 MIPS performance period. Despite not being suitable for 
scoring, both SSMs provide important information about patient care. 
Qualitative work suggests that ``Access to Specialists'' is a critical 
issue for Medicare FFS beneficiaries. The survey is also a useful tool 
for assessing beneficiaries' self-reported health status and functional 
status, even if this measure is not used for scoring practices' care 
experiences. Therefore, we believed that continued collection of the 
data for these two SSMs is appropriate even though we do not propose to 
score them.
    Other than these two SSMs, we proposed to score the remaining 8 
SSMs because they have had high reliability for scoring in prior years, 
or reliability is expected to improve for the revised version of the 
measure, and they also represent elements of patient experience for 
which we can measure the effect one practice has compared to other 
practices participating in MIPS.
    We invited comment on our proposal not to score the ``Health Status 
and Functional Status'' and ``Access to Specialists'' SSMs beginning 
with the 2018 MIPS performance period.
    The following is a summary of the public comments received on our 
proposal to not score ``Health Status and Functional Status'' and 
``Access to Specialists'' SSMs beginning with the 2018 MIPS performance 
period:
    Comment: One commenter supported CMS's proposal not to score the 
two SSMs in the CAHPS for MIPS measure, agreeing that CMS should only 
use the 8 SSMs with high reliability to calculate the CAHPS for MIPS 
score.
    Response: We appreciate commenters' support to not score the 
``Health Status and Functional Status'' and ``Access to Specialists'' 
SSMs beginning with the 2018 MIPS performance period.
    Comment: Several commenters did not support the proposal to not 
score the ``Health Status and Functional Status'' SSM and argued that 
the functional status SSM provides valuable insights and connect to 
health outcomes in a meaningful way.
    Response: We agree with commenters on the value of the ``Health 
Status and Functional Status'' SSM and will continue to collect data on 
both the ``Health Status and Functional Status'' and ``Access to 
Specialists'' SSMs even though we will no longer score them. Our 
concern is that the ``Health Status and Functional Status'' SSM is not 
a reliable indicator of patient care and experience for scoring 
purposes. As we described above, the ``Health Status and Functional 
Status'' SSM reflects more of the characteristics of a group's patient 
population than patient experience and does not allow for an adequate 
assessment of how much the score is a result of patient experience or 
aspects of the underlying health of patients. Additionally, the 
``Access to Specialists'' SSM has historically had small sample sizes, 
making it highly unreliable, and thus we feel it is not appropriate for 
it to be included in scoring.
    Final Action: After consideration of public comments, we are 
finalizing the proposal to not score the ``Health Status and Functional 
Status'' and ``Access to Specialists'' SSMs beginning with the 2018 
MIPS performance period, as proposed. We noted in the CY 2018 Quality 
Payment Program proposed rule that we proposed to add the CAHPS for 
ACOs survey as an available measure for calculating the MIPS APM score 
for the Shared Savings Program and Next Generation ACO Model (82 FR 
30082 through 30083). We refer readers participating in ACOs to section 
II.C.6.g.(3)(b) of this final rule with comment period for the 
discussion of the CAHPS for ACOs scoring methodology.
    Table 17 summarizes the newly finalized SSMs included in the CAHPS 
for MIPS survey and illustrates application of our policy to score only 
8 measures.

                            Table 17--Newly Finalized SSM for CAHPS for MIPS Scoring
----------------------------------------------------------------------------------------------------------------
                                                   Newly finalized for inclusion   Newly finalized for inclusion
             Summary survey measure                in the CAHPS for MIPS survey?    in CAHPS for MIPS scoring?
----------------------------------------------------------------------------------------------------------------
Getting Timely Care, Appointments, and            Yes...........................  Yes.
 Information.
How Well Providers Communicate..................  Yes...........................  Yes.
Patient's Rating of Provider....................  Yes...........................  Yes.
Health Promotion & Education....................  Yes...........................  Yes.
Shared Decision Making..........................  Yes...........................  Yes.
Stewardship of Patient Resources................  Yes...........................  Yes.
Courteous and Helpful Office Staff..............  Yes...........................  Yes.
Care Coordination...............................  Yes...........................  Yes.
Health Status and Functional Status.............  Yes...........................  No.
Access to Specialists...........................  Yes...........................  No.
----------------------------------------------------------------------------------------------------------------


[[Page 53721]]

(c) Identifying and Assigning Measure Achievement Points for Topped Out 
Measures
    Section 1848(q)(3)(B) of the Act requires that, in establishing 
performance standards with respect to measures and activities, we 
consider, among other things, the opportunity for continued 
improvement. We finalized in the CY 2017 Quality Payment Program final 
rule that we would identify topped out process measures as those with a 
median performance rate of 95 percent or higher (81 FR 77286). For non-
process measures we finalized a topped out definition similar to the 
definition used in the Hospital VBP Program: The truncated coefficient 
of variation is less than 0.10 and the 75th and 90th percentiles are 
within 2 standard errors (81 FR 77286). When a measure is topped out, a 
large majority of clinicians submitting the measure performs at or very 
near the top of the distribution; therefore, there is little or no room 
for the majority of MIPS eligible clinicians who submit the measure to 
improve. We understand that every measure we have identified as topped 
out may offer room for improvement for some MIPS eligible clinicians; 
however, we believe asking clinicians to submit measures that we have 
identified as topped out and measures for which they already excel is 
an unnecessary burden that does not add value or improve beneficiary 
outcomes.
    Based on 2015 historic benchmark data,\4\ approximately 45 percent 
of the quality measure benchmarks currently meet the definition of 
topped out, with some submission mechanisms having a higher percent of 
topped out measures than others. Approximately 70 percent of claims 
measures are topped out, 10 percent of EHR measures are topped out, and 
45 percent of registry/QCDR measures are topped out.
---------------------------------------------------------------------------

    \4\ The topped out determination is calculated on historic 
performance data and the percentage of topped out measures may 
change when evaluated for the most applicable annual period.
---------------------------------------------------------------------------

    In the CY 2017 Quality Payment Program final rule, we finalized 
that for the 2019 MIPS payment year, we would score topped out quality 
measures in the same manner as other measures (81 FR 77286). We 
finalized that we would not modify the benchmark methodology for topped 
out measures for the first year that the measure has been identified as 
topped out, but that we would modify the benchmark methodology for 
topped out measures beginning with the 2020 MIPS payment year, provided 
that it is the second year the measure has been identified as topped 
out. In the CY 2018 Quality Payment Program proposed rule (82 FR 30103 
through 30106), we proposed a phased in approach to apply special 
scoring to topped out measures, beginning with the 2018 MIPS 
performance period (2020 MIPS payment year), rather than modifying the 
benchmark methodology for topped out measures as indicated in the CY 
2017 Quality Payment Program final rule. We also provided a summary of 
comments received in response to the CY 2017 Quality Payment Program 
final rule (82 FR 30103 through 30104) on how topped out measures 
should be scored provided that it is the second year the measure has 
been identified as topped out.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30045 
through 30047), we proposed a lifecycle for topped out measures by 
which, after a measure benchmark is identified as topped out in the 
published benchmark for 2 years, in the third consecutive year it is 
identified as topped out it will be considered for removal through 
notice-and-comment rulemaking or the QCDR approval process and may be 
removed from the benchmark list in the fourth year, subject to the 
phased in approach described in section II.C.6.c.(2) of this final rule 
with comment period.
    We also stated in the CY 2017 Quality Payment Program final rule 
that we do not believe it would be appropriate to remove topped out 
measures from the CMS Web Interface for the Quality Payment Program 
because the CMS Web Interface measures are used in MIPS and in APMs 
such as the Shared Savings Program and because we have aligned 
policies, where possible, with the Shared Savings Program, such as 
using the Shared Savings Program benchmarks for the CMS Web Interface 
measures (81 FR 77285). In the CY 2017 Quality Payment Program final 
rule, we also finalized that MIPS eligible clinicians submitting via 
the CMS Web Interface must submit all measures included in the CMS Web 
Interface (81 FR 77116). Thus, if a CMS Web Interface measure is topped 
out, the CMS Web Interface submitter cannot select other measures. 
Because of the lack of ability to select measures, we did not propose 
to apply the proposed special scoring adjustment to topped out measures 
for CMS Web Interface for the Quality Payment Program (82 FR 30106).
    Additionally, because the Shared Savings Program incorporates a 
methodology for measures with high performance into the benchmark, we 
noted that we do not believe capping benchmarks from the CMS Web 
Interface for the Quality Payment Program is appropriate. We finalized 
in the CY 2017 Quality Payment Program final rule at Sec.  
414.1380(b)(1)(ii)(A) to use benchmarks from the corresponding 
reporting year of the Shared Savings Program. The Shared Savings 
Program adjusts some benchmarks to a flat percentage when the 60th 
percentile is equal to or greater than 80.00 percent for individual 
measures (78 FR 74759 through 74763), and, for other measures, 
benchmarks are set using flat percentages when the 90th percentile for 
a measure are equal to or greater than 95.00 percent (79 FR 67925). 
Thus, we did not propose to apply the topped out measure cap to 
measures in the CMS Web Interface for the Quality Payment Program.
    Starting with the 2019 MIPS performance period, we proposed to 
apply the special topped out scoring method to all topped out measures, 
provided it is the second (or more) consecutive year the measure is 
identified as topped out (82 FR 30103 through 30106). We sought comment 
on our proposal to apply special topped out scoring to all topped out 
measures, provided it is the second (or more) consecutive year the 
measure is identified as topped out. We also sought comment on the 
proposal not to apply the topped out measure cap to measures in the CMS 
Web Interface for the Quality Payment Program. We refer readers to 
section II.C.6.c.(2) of this final rule with comment period for a 
summary of the comments we received and our responses.
    As part of the lifecycle for topped out measures, we also proposed 
a method to phase in special scoring for topped out measure benchmarks 
starting with the 2018 MIPS performance period, provided that is the 
second consecutive year the measure benchmark is identified as topped 
out in the benchmarks published for the performance period (82 FR 30103 
through 30106). This special scoring would not apply to measures in the 
CMS Web Interface, as explained later in this section. The phased-in 
approach described in this section represents our first step in 
methodically implementing special scoring for topped out measures.
    We did not propose to remove topped out measures for the 2018 MIPS 
performance period because we recognize that there are currently a 
large number of topped out measures and removing them may impact the 
ability of some MIPS eligible clinicians to submit 6 measures and may 
impact some specialties more than others. We noted, however, that we 
proposed a timeline for removing topped out measures in future years 
(82 FR 30046). We believe this provides MIPS eligible

[[Page 53722]]

clinicians the ability to anticipate and plan for the removal of 
specific topped out measures, while providing measure developers time 
to develop new measures.
    We noted that because we create a separate benchmark for each 
submission mechanism available for a measure, a benchmark for one 
submission mechanism for the measure may be identified as topped out 
while another submission mechanism's benchmark may not be topped out. 
The topped out designation and special scoring apply only to the 
specific benchmark that is topped out, not necessarily every benchmark 
for a measure. For example, the benchmark for the claims submission 
mechanism may be topped out for a measure, but the benchmark for the 
EHR submission mechanisms for that same measure may not be topped out. 
In this case, the topped out scoring would only apply to measures 
submitted via the claims submission mechanism, which has the topped out 
benchmark. We also described that only the submission mechanism that is 
topped out for the measure would be removed (82 FR 30104).
    We proposed to cap the score of topped out measures at 6 measure 
achievement points. We proposed a 6-point cap for multiple reasons. 
First, we noted that we believe applying a cap to the current method of 
scoring a measure against a benchmark is a simple approach that can 
easily be predicted by clinicians. Second, the cap will create 
incentives for clinicians to submit other measures for which they can 
improve and earn future improvement points. Third, considering the 
proposed topped out measure lifecycle, we believed this cap would only 
be used for a few years and the simplicity of a cap on the current 
benchmarks would outweigh more complicated approaches to scoring such 
as a cluster-based options or applying a cap on benchmarks based on 
flat-percentage (see 82 FR 30103 through 30104). The rationale for a 6-
point cap is that 6 points is the median score for any measure as it 
represents the start of the 6th decile for performance and represents 
the spot between the bottom 5 deciles and start of the top 5 deciles.
    We believed the proposed capped scoring methodology would 
incentivize MIPS eligible clinicians to begin submitting non-topped out 
measures without performing below the median score. This methodology 
also would not impact scoring for those MIPS eligible clinicians that 
do not perform near the top of the measure, and therefore, have 
significant room to improve on the measure. We noted that we may also 
consider lowering the cap below 6 points in future years, especially if 
we remove the 3-point floor for performance in future years.
    Although we proposed a new methodology for assigning measure 
achievement points for topped out measures, we did not propose to 
change the policy for awarding measure bonus points for topped out 
measures. Topped out measures will still be eligible for measure bonus 
points if they meet the required criteria. We refer readers to sections 
II.C.7.a.(2)(f) and II.C.7.a.(2)(g) of this final rule with comment 
period for more information about measure bonus points.
    While we believe it is important to score topped out measures 
differently because they could have a disproportionate impact on the 
scores for certain MIPS eligible clinicians and topped out measures 
provide little room for improvement for the majority of MIPS eligible 
clinicians who submit them, we also recognize that numerous measure 
benchmarks are currently identified as topped out, and special scoring 
for topped out measures could impact some specialties more than others. 
Therefore, we considered ways to phase in special scoring for topped 
out measures in a way that will begin to apply special scoring, but 
would not overwhelm any one specialty and would also provide additional 
time to evaluate the impact of topped out measures before implementing 
it for all topped out measures, while also beginning to encourage 
submission of measures that are not topped out.
    We believe the best way to accomplish this is by applying special 
topped out scoring to a select number of measures for the 2018 MIPS 
performance period and to then apply the special topped out scoring to 
all topped out measures for the 2019 MIPS performance period, provided 
it is the second consecutive year the measure is topped out. We believe 
this approach allows us time to further evaluate the impact of topped 
out measures and allows for a methodical way to phase in topped out 
scoring.
    We identified measures we believe should be scored with the special 
topped out scoring for the 2018 performance period by using the 
following set criteria, which are only intended as a way to phase in 
our topped-out measure policy for selected measures and are not 
necessarily intended to be criteria for use in future policies:
     Measure is topped out and there is no difference in 
performance between decile 3 through decile 10. We applied this 
limitation because, based on historical data, there is no room for 
improvement for over 80 percent of MIPS eligible clinicians that 
reported on these measures.
     Process measures only because we want to continue to 
encourage reporting on high priority outcome measures, and the small 
subset of structure measures was confined to only three specialties.
     MIPS measures only (which does not include measures that 
can only be reported through a QCDR) given that QCDR measures go 
through a separate process for approval and because we want to 
encourage use of QCDRs required by section 1848(q)(1)(E) of the Act.
     Measure is topped out for all mechanisms by which the 
measure can be submitted. Because we create a separate benchmark for 
each submission mechanism available for a measure, a benchmark for one 
submission mechanism for the measure may be identified as topped out 
while another submission mechanism's benchmark may not be topped out. 
For example, the benchmark for the claims submission mechanism may be 
topped out for a measure, but the benchmark for the EHR submission 
mechanisms for that same measure may not be topped out. We decided to 
limit our criteria to only measures that were topped out for all 
mechanisms for simplicity and to avoid confusion about what scoring is 
applied to a measure.
     Measure is in a specialty set with at least 10 measures, 
because 2 measures in the pathology specialty set, which only has 8 
measures total, would have been included.
    Applying these criteria resulted in the 6 measures as listed in 
Table 18.

[[Page 53723]]



         Table 18--Proposed Topped Out Measures for Special Scoring for the 2018 MIPS Performance Period
----------------------------------------------------------------------------------------------------------------
                                                                       Topped out for all
         Measure name             Measure ID        Measure type           submission          Specialty set
                                                                           mechanisms
----------------------------------------------------------------------------------------------------------------
Perioperative Care: Selection               21  Process.............  Yes................  General Surgery,
 of Prophylactic Antibiotic--                                                               Orthopedic Surgery,
 First OR Second Generation                                                                 Otolaryngology,
 Cephalosporin.                                                                             Thoracic Surgery,
                                                                                            Plastic Surgery.
Melanoma: Overutilization of               224  Process.............  Yes................  Dermatology.
 Imaging Studies in Melanoma.
Perioperative Care: Venous                  23  Process.............  Yes................  General Surgery,
 Thromboembolism (VTE)                                                                      Orthopedic Surgery,
 Prophylaxis (When Indicated                                                                Otolaryngology,
 in ALL Patients).                                                                          Thoracic Surgery,
                                                                                            Plastic Surgery.
Image Confirmation of                      262  Process.............  Yes................  n/a.
 Successful Excision of Image-
 Localized Breast Lesion.
Optimizing Patient Exposure to             359  Process.............  Yes................  Diagnostic Radiology.
 Ionizing Radiation:
 Utilization of a Standardized
 Nomenclature for Computerized
 Tomography (CT) Imaging
 Description.
Chronic Obstructive Pulmonary               52  Process.............  Yes................  n/a.
 Disease (COPD): Inhaled
 Bronchodilator Therapy.
----------------------------------------------------------------------------------------------------------------

    We proposed to apply the special topped out scoring method to only 
the 6 measures in Table 18 for the 2018 MIPS performance period, 
provided they are again identified as topped out in the benchmarks for 
the 2018 MIPS performance period. If these measures are not identified 
as topped out in the benchmarks published for the 2018 MIPS performance 
period, they will not be scored differently because they would not be 
topped out for a second consecutive year.
    Finally, we proposed to add a new paragraph at Sec.  
414.1380(b)(1)(xiii) to codify our proposal for the lifecycle for 
removing topped out measures. We also proposed to add at Sec.  
414.1380(b)(1)(xiii)(A) that for the 2018 MIPS performance period, the 
6 measures identified in Table 18 will receive a maximum of 6 measure 
achievement points, provided that the measure benchmarks are identified 
as topped out again in the benchmarks published for the 2018 MIPS 
performance period. We also proposed to add at Sec.  
414.1380(b)(1)(xiii)(B) that beginning with the 2019 MIPS performance 
period, measure benchmarks, except for measures in the CMS Web 
Interface, that are identified as topped out for two 2 or more 
consecutive years will receive a maximum of 6 measure achievement 
points in the second consecutive year it is identified as topped out, 
and beyond.
    We requested comments on our proposal to score topped out measures 
differently by applying a 6-point cap, provided it is the second 
consecutive year the measure is identified as topped out. Specifically, 
we sought feedback on whether 6 points is the appropriate cap or 
whether we should consider another value. We also sought comment on our 
proposal to apply special topped out scoring only to the 6 measures 
identified in Table 18 for the 2018 MIPS performance period. We also 
sought comment on our proposal to amend the regulatory text to align 
with these proposed policies.
    The following is a summary of the public comments received on the 
proposal to cap topped out measures at 6-points and our responses:
    Comment: Many commenters supported the proposal to cap topped out 
measures at 6 points because commenters believed the proposal is a 
simplified approach to assigning points to topped out measures, aligns 
with certain state programs, and will encourage reporting of other 
measures that are more meaningful.
    Response: As we note below, we have been persuaded by other 
commenters that this adjustment is too abrupt a change to provide in 
the 2018 MIPS performance period, so as described below, we intend to 
apply a scoring cap but are modifying the proposal as described below.
    Comment: Several commenters recommended a more gradual reduction of 
points because commenters believed the 6-point cap did not acknowledge 
high performance and was too steep a drop in points because measure 
benchmarks are not based on MIPS data, selection of measures from a 
menu may result in only high performers submitting topped out measures 
which could still provide opportunities for improvement, and submitters 
have limited measure alternatives for reporting. Commenters recommended 
higher point values ranging from 7 to 8, when capping topped out 
measures. A few commenters recommended 7 points for topped out 
measures, excluding outcome measures and cross cutting measures, which 
commenters believed should be allowed a maximum point value, to prevent 
penalizing eligible clinicians with limited options for measures when 
reporting topped out measures due to limitations largely outside of 
their control. One commenter recommended that topped out measures be 
capped at 8 points in year 2 of the designation as a topped out measure 
and 6 points in year 3 of the designation, providing a more gradual 
reduction of points for reporting topped out measures. A few commenters 
recommended capping topped out measures at 7.5 points, representing the 
lowest possible points associated with the upper quartile of 
performance. The commenters believed that the 7.5 points would align 
with CMS definition of a topped-out measure that the truncated 
coefficient of variation is less than 0.10 and the 75th and 90th 
percentiles are within two standard errors (a test of whether the range 
of scores in the upper quartile is statistically meaningful). The 
commenters believed this would still discourage clinicians from 
continuing to report topped out measures because the scores would be 
capped and the measures are ineligible for improvement points. The 
commenters believed the higher scores are more aligned with points 
assigned for upper quartile performance, acknowledging high 
performance.
    Response: We acknowledge the commenters' concerns with the 6-point 
cap and recommendations to increase the point value to acknowledge 
performance and allow a more gradual reduction in the achievement score 
of topped out measures. The benchmarks for the 2017 performance period 
are derived from the measure's historical

[[Page 53724]]

performance data which would be reflective of the measure's anticipated 
performance in the future. We believe our policy approach of using a 
cap set at 6 points (which represents the median score in our 
benchmark) and phasing in this cap by only applying it to selected 
measures for the 2018 MIPS performance period (see section II.C.6.c.(2) 
in this final rule with comment period) provides a simple policy 
solution and addresses many concerns about a disproportionate number of 
topped out measures affecting clinicians for the 2018 performance 
period. However, we do understand that a significant number of measures 
may qualify for this scoring cap starting in the 2019 MIPS performance 
period/2021 MIPS payment year, which could affect scores for MIPS 
eligible clinicians with a limited choice of measures. Therefore, we 
have been persuaded by the comments to increase the scoring cap to 7 
points. We chose 7 points for several reasons. First, for simplicity in 
the scoring system, we believe we should have a single integer number 
cap for all topped out measures that are subject to the cap. We believe 
it would be easier for clinicians to understand a cap of 7 points than 
a policy which uses partial points or a system that gradually decreases 
points the longer a measure is topped out. One additional component in 
assuring consistency in scoring is to apply the scoring cap to all 
identified topped out measures, including outcome and cross-cutting 
measures. Second, 7 points is higher than the median, so this cap 
provides credit for good performance. Finally, the 7 point cap would 
mitigate to some degree the scoring concerns for clinicians who have a 
large number of topped out measures, while still providing incentives 
to all eligible clinicians to submit measures that are not topped out. 
We will monitor the scoring cap and address any changes through future 
rulemaking.
    Comment: One commenter supported the 6-point cap but recommended 
maintaining measures at a reduced point cap rather than removing 
measures that might have a critical position in clinical care pathways.
    Response: We acknowledge concerns about maintaining measures that 
support clinical care pathways, but we believe that considering the 
removal of topped out measures beginning with the 2019 MIPS performance 
period, subject to removal criteria, is more appropriate than 
maintaining an indefinite cap on scoring. Measures considered for 
removal would need to go through notice and comment rulemaking, and 
commenters would have the opportunity to provide feedback on the 
measure before we finalize a measure removal.
    Comment: One commenter indicated that a cap of 6 points or a 
similar median score would be appropriate if performance improvement 
could not be statistically measured.
    Response: We continue to believe that capping the score is a 
reasonable and simple way to score topped out measures, although we 
have been persuaded by commenters that the 6-point cap is potentially 
too large a change, and, as described above, we are modifying the 
proposal slightly. While we will still cap the score, we will cap it at 
7 points rather than 6. The commenter did not provide additional detail 
on how improvement should be statistically measured, however, in 
section II.C.7.a.(2)(i)(v) of this final rule with comment, we seek 
comments on how to adjust our scoring policies and meet our policy 
goals and would welcome additional discussion on how this approach 
could be implemented in MIPS.
    Comment: Many commenters did not support a scoring cap for topped 
out measures because commenters believed that CMS should be rewarding 
an eligible clinician's ability to achieve and maintain high 
performance, that all MIPS measures should be scored in the same way to 
minimize scoring complexity, and that many topped out measures may 
still represent an opportunity to encourage quality improvement. In 
addition, some commenters believed that a scoring cap should not be 
applied because topped out measures reflect performance of only high 
performers who selected the measures and therefore should not be 
considered topped out for all MIPS eligible clinicians.
    Response: We disagree with the commenters that a scoring cap is 
inappropriate. We believe that MIPS eligible clinicians generally 
should have the flexibility to select measures most relevant to their 
practice, but a trade-off of this flexibility is that not all MIPS 
eligible clinicians are reporting the same measure. As MIPS is a 
performance-based program, we do not believe that topped out measures 
should be scored the same way as other measures that can demonstrate 
achievement by showing variation in performance and room for 
improvement. In particular, it is difficult to assess whether the lack 
of variation in performance is truly due to lack of variation among all 
clinicians or if it is just due to lack of variation among the 
clinicians who are submitting the measures. If it is the latter and 
more clinicians report the measure, and we have a more robust benchmark 
and see variation in performance, then we would no longer classify the 
measure as topped out. Thus, while we agree that some measures 
initially identified as topped out may later show room for improvement 
if additional MIPS eligible clinicians report the measures, we note 
that we have not seen any variation in performance on the 6 measures 
proposed for the scoring cap applied in 2018 MIPS performance period. 
We continue to see a cap as a simple approach that is predictable for 
clinicians and creates incentives to select other non-topped out 
measures. However, we understand the concerns of the commenters; 
therefore, we are finalizing an increase to the cap from 6 measure 
achievement points to 7 measure achievement points, which does 
acknowledge better than average performance on measure achievement. We 
believe the scoring cap would only be used for a few years because we 
anticipate that topped out measures generally will be removed after 3 
years through future rulemaking, and the simplicity of the cap on 
current benchmarks makes this scoring approach an attractive 
alternative to more complex scoring schemes. We will continue to 
consider if additional factors need to be taken into account as we 
score topped out measures, and if needed, we will make further 
proposals in future rulemaking. In addition, we expect to incorporate 
new measures into MIPS. We refer readers to section II.C.6.c.(1) of 
this final rule with comment period for further discussion on measure 
development.
    Comment: A few commenters indicated that capping the score of 
topped out measures may result in a gap in available achievement points 
available for quality measures for some MIPS eligible clinicians. A few 
commenters believed that some high-volume services may have only topped 
out measures, which would limit the achievement points available to 
MIPS eligible clinicians providing care to those patients. 
Additionally, a few commenters believed that MIPS eligible clinicians 
do not have control over the measures available in the program and 
should be able to report, and potentially receive full achievement 
points, on measures that are relevant to their patient population and 
scope of practice.
    Response: We acknowledge the concern about the availability of 
measures that are eligible for the full 10 measure achievement points. 
The majority of quality measures used in

[[Page 53725]]

MIPS are developed by external stakeholders, and as discussed in 
section II.C.6.c.(1) of this final rule with comment period, we intend 
to work with developers using the Measure Development Plan as a 
strategic framework to add new measures into MIPS. While these measures 
are being developed and refined, we have multiple policies to mitigate 
the impact of topped out measures. For the 2018 MIPS performance 
period, we are only finalizing 6 topped out measures to which the 
scoring cap will apply. In the 2019 MIPS performance period, MIPS 
eligible clinicians will be able to submit quality data using more than 
one submission mechanism, which may increase the availability of non-
topped out measures for some MIPS eligible clinicians. Finally, as 
discussed in section II.C.6.c.(2) of this final rule with comment 
period, we will consider the impact of the topped out measure lifecycle 
on certain clinicians in future rulemaking and refine our policies if 
needed.
    Comment: A few commenters indicated that a scoring cap should not 
be used for QCDR measures because the measures are relatively new and 
QCDRs have only recently begun collecting performance data. The 
commenters noted that QCDRs should be allowed to promote the submission 
of QCDR measures for several years to understand performance trends 
before identifying topped out measures. One commenter requested a delay 
in the implementation of scoring caps for QCDR submissions because the 
commenter believed that the additional time would increase submission 
rates and support specialty MIPS eligible clinicians who are new to 
quality reporting.
    Response: We believe that the scoring cap should be applied to 
measures submitted through all submission mechanisms. Although the 
scoring cap applies to measures submitted via QCDR (including both MIPS 
measures and QCDR measures), the topped out measures identified for the 
scoring cap for the 2018 MIPS performance period do not include any 
QCDR measures. Therefore, there is no immediate impact on the 
submission of additional data on QCDR measures, which potentially 
reduces the likelihood that any QCDR measures would be considered 
topped out in future years. Therefore, we do not believe it is 
necessary to delay implementation of scoring caps for QCDR submissions. 
We will monitor how the application of the scoring cap affects measure 
selection and propose any changes in future rulemaking.
    Comment: One commenter did not support the scoring cap because it 
might penalize clinicians and groups who have invested in EHR 
technology and workflow design required to perform well on topped out 
measures.
    Response: We want to encourage the continued use of using EHR 
technology for quality improvement. We continue to evaluate methods to 
encourage the use of EHR technology, including the end-to-end 
electronic reporting bonus available to measures submitted through an 
EHR submission mechanism, regardless of whether they are topped out. We 
note that topped out measures are identified through benchmarks for 
each submission mechanism, and EHR measures have a lower proportion of 
topped out measures compared to other submission mechanisms, which 
limits the impact of any topped out special scoring policy. We will 
monitor how the application of the scoring cap affects measure 
selection during the topped out lifecycle.
    Comment: A few commenters recommended that clinicians caring for 
American Indian and Alaska Native patients be excluded from the scoring 
cap for topped out measures because the commenters believed that if 
clinicians are performing well on a quality measure, they should be 
awarded maximum points.
    Response: To our knowledge, there are no measures in MIPS that are 
specific to this population; however, there is a large variety of 
measures overall for selection. We do not believe it would be 
appropriate to exclude clinicians caring for American Indian and Alaska 
Native patients at this time because the policy for topped out measures 
encourages selection of non-topped out measures that have an 
opportunity for improvement of value and beneficiary outcomes, 
including this specific population. For clinicians in small practices 
caring for American Indian and Alaskan Native patients, there are 
flexibilities built into MIPS, including the low-volume threshold 
affecting eligibility for MIPS and, for those participating, bonus 
points applied when calculating the final score.
    Comment: Several commenters had specific recommendations to amend 
CMS's proposed topped out measure scoring. One commenter recommended 
eliminating the cap or awarding full points over an expanded timeline 
to phase out topped out measures over a 6-year period or longer. One 
commenter urged CMS to not apply a scoring cap for clinical specialists 
with limited numbers of measures to report that are not topped out. One 
commenter indicated that scoring should be restructured to limit the 
number of topped out measures that would receive the capped score or 
provide a bonus structure to add extra points for reporting on capped 
topped out measures to ensure that eligible clinicians are not 
penalized for submission of topped out measures. One commenter 
recommended that CMS consider the ABC methodology to evaluate variation 
in performance when identifying topped out measures for the scoring 
cap.
    Response: We believe that topped out measures should not be scored 
the same way as other measures that show variation and room for 
improvement, and that a measure cap is an appropriate approach that 
does not add complexity to scoring. We believe the scoring cap should 
be applied to all topped out measures submitted and that, although 
bonus points are available for topped out measures that are additional 
high priority measures and/or submitted via end-to-end reporting, bonus 
points specifically for topped out measures would not be appropriate or 
provide incentives for eligible clinicians to submit measures are not 
topped out. We appreciate the commenters' suggestions, which we may 
consider for future rulemaking; however, we believe that the lifecycle 
finalized at section II.C.6.c.(2) of this final rule with comment 
period provides sufficient notice to stakeholders, including measure 
developers, to create alternative measures if needed, and we believe 
that the scoring policy should be applied consistently across clinical 
specialties and submissions mechanisms regardless of the number of 
topped out measures available and submitted. In the interim, we believe 
a cap of 7 points addresses some stakeholder concerns while providing a 
simple way to score topped out measures. We will continue to evaluate 
application of the scoring policy during the topped out lifecycle.
    The following is a summary of the public comments received on the 
proposal to not apply the topped out measure scoring cap to measures in 
the CMS Web Interface and our responses:
    Comment: A few commenters did not support CMS's proposal to exclude 
CMS Web Interface measures from the special scoring policy and 
encouraged CMS to develop an approach to apply the topped out policy to 
the CMS Web Interface measures. One commenter believed that allowing 
clinicians reporting through the CMS Web Interface to earn full points 
for reporting topped out measures would unfairly advantage the final 
score for these reporters compared to other clinicians. The commenter 
recommended that CMS

[[Page 53726]]

work with developers on more meaningful measures for the CMS Web 
Interface.
    Response: We continue to believe that it would be inappropriate to 
cap scoring for topped out measures from the CMS Web Interface, which 
we believe provides meaningful measures for MIPS eligible clinicians. 
The CMS Web Interface measures are used in MIPS and APMs such as the 
Shared Savings Program, and we have aligned policies where possible, 
including using the Shared Savings Programs benchmarks for the CMS Web 
Interface measures. In addition, the lack of ability to select measures 
would mean that applying topped out scoring would create a disadvantage 
for CMS Web Interface submitters as they would not have the ability to 
choose alternative measures. We would be interested in working with a 
broad stakeholder group and developers as appropriate to identify 
additional measures that should be in CMS Web Interface. We will 
continue to coordinate with the Shared Savings Program to discuss any 
future modifications to scoring or modifications to measures in the CMS 
Web Interface.
    The following is a summary of the public comments received on the 
proposal to apply topped out measure policy for the 6 selected measures 
in Table 18 for the 2018 MIPS performance period and our responses:
    Comment: A few commenters supported CMS's proposed special scoring 
for the 6 topped out measures in the 2018 MIPS performance period.
    Response: We appreciate the commenters' support.
    Comment: A few commenters did not support the special scoring and 
potential future removal of the 6 topped out measures proposed for 
special scoring, citing specific measures that are important to 
specialists and included in specialty measurement sets. One commenter 
recommended the inclusion of a replacement measure if capping the score 
for the measure Chronic Obstructive Pulmonary Disease (measure 52), 
because the commenter believed without replacement there will be a gap 
in the program. A few commenters did not support including the 
Perioperative Care Measure: Selection of Prophylactic Antibiotic 
(measure 21) because commenters believed it is an important measure to 
identify patient outcomes and is crucial to maintain high quality care. 
One commenter did not support the inclusion of the Perioperative Care 
measures (measures 21 and 23) in the list of topped out measures 
because the commenter believed that the measures are important to 
support patient safety. One commenter recommended that CMS consult 
stakeholders and literature on the importance of measures for patient 
safety and clinical significance, and consider developing a 
perioperative composite measure rather than capping and eventually 
removing the two perioperative care measures. The commenter believed a 
replacement process, including development of composite measures, would 
ensure that sufficient measures are available and appropriate to 
specialties and potentially demonstrate variation in performance to 
identify opportunities for improvement.
    Response: We acknowledge the concerns of commenters regarding the 
availability of measures. We note that the finalized policy is to cap 
the score of 6 specific measures for the CY 2018 performance period, 
and that any potential removal of measures would occur only through 
future rulemaking, which would be proposed after consulting appropriate 
literature and include stakeholder feedback. We refer readers to 
section II.C.6.c.(2) of this final rule with comment period for 
additional discussion on the lifecycle of topped out measures, 
including the consideration of criteria for the identification and 
potential removal of measures. In terms of scoring, we do not believe 
that a MIPS eligible clinician electing to report topped out measures 
should be able to receive the same maximum score as MIPS eligible 
clinicians electing to report other measures. Therefore, we believe 
that scoring of the 6 identified topped out measures, including 
measures 52, 21 and 23 discussed above, should be capped. In terms of 
recommendations to replace measures and develop composite measures, we 
will consider these recommendations for future rulemaking. As discussed 
in section II.C.6.c.(1) of this final rule with comment period, we 
intend to work with developers using the Measure Development Plan as a 
strategic framework to add new measures into MIPS. We will share the 
commenters' recommendations regarding the need for new measures and a 
composite measure. We encourage stakeholders to develop and submit 
measures and composite measures for consideration.
    We also sought comment on other possible options for scoring topped 
out measures that would meet our policy goals to encourage clinicians 
to begin to submit measures that are not topped out while also 
providing stability for MIPS eligible clinicians. We specifically 
sought comment on whether the proposed policy to cap the score of 
topped out measures beginning with the 2019 MIPS performance period 
should apply to SSMs in the CAHPS for MIPS survey measure or whether 
there is another alternative policy that could be applied for the CAHPS 
for MIPS survey measure due to high, unvarying performance within the 
SSM. We noted that we would like to encourage groups to report the 
CAHPS for MIPS survey as it incorporates beneficiary feedback.
    We thank the commenters for their feedback and will take their 
suggestions into consideration in future rulemaking.
    We did not receive any public comments specific to our proposal to 
change the regulatory text at Sec.  414.1380(b)(1)(xiii)(A) and Sec.  
414.1380(b)(1)(xiii)(B).
    Final Action: After consideration of all comments, we are 
finalizing with modifications the proposed policy to apply the special 
scoring cap to topped out measures. Specifically, we are finalizing a 
scoring cap of 7 points, rather than the proposed 6 points. We are 
finalizing a 7-point cap for multiple reasons. First, we believe 
applying the special scoring cap is a simple approach that can be 
easily predicted by clinicians. Second, the cap will create incentives 
for clinicians to submit other measures for which they can improve and 
earn future improvement points. Third, the rationale for the point 
value is that 7 points is slightly higher than the median score for any 
measure and will address the near-term concerns that clinicians have 
about the lack of additional, non-topped out measures for submission 
and still provide an above median award for good performance. In 
addition, we are finalizing our proposed policy that we will not apply 
the topped out measure cap to measures in the CMS Web Interface for the 
Quality Payment Program. We also appreciate the input and suggestions 
on the best way to proceed with topped out SSMs in the CAHPS for MIPS 
survey measures, and we will take it into consideration in future 
rulemaking. Additionally, we are finalizing our proposal to apply that 
the special scoring policy to the 6 selected measures in Table 18 for 
the 2018 MIPS performance period and 2020 MIPS payment year.
    Finally, we are finalizing the proposed regulatory text changes 
with some modifications to reflect the other policies we are 
finalizing. We are finalizing amendments to Sec.  
414.1380(b)(1)(xiii)(A) to read that, for the 2020 MIPS payment year, 
the 6 measures identified in Table 18 will receive a maximum of 7 
measure achievement points, provided that for the applicable submission 
mechanisms the measure benchmarks are identified as topped out again in 
the benchmarks

[[Page 53727]]

published for the 2018 MIPS performance period. We will also amend 
Sec.  414.1380(b)(1)(xiii)(B) to read that, beginning with the 2021 
MIPS payment year, measure benchmarks, except for measures in the CMS 
Web Interface, that are identified as topped out for 2 or more 
consecutive years will receive a maximum of 7 measure achievement 
points in the second consecutive year it is identified as topped out, 
and beyond. We will continue to consider if additional factors need to 
be taken into account as we score topped out measures, and if needed, 
we will make further proposals in future rulemaking.
    Together the finalized policies for phasing in capped scoring and 
removing topped out measures are intended to provide an incentive for 
MIPS eligible clinicians to begin to submit measures that are not 
topped out while also providing stability by allowing MIPS eligible 
clinicians who have few alternative measures to continue to receive 
standard scoring for most topped out measures for an additional year, 
and not perform below the median score for those 6 measures that 
receive special scoring. It also provides MIPS eligible clinicians the 
ability to anticipate and plan for the removal of specific topped out 
measures, while providing measure developers time to develop new 
measures. Below is an illustration of the lifecycle for scoring and 
removing topped out measures based on our newly finalized policies:
     Year 1: Measure are identified as topped out, which in 
this example would be in the benchmarks published for the 2017 MIPS 
performance period. The 2017 benchmarks are posted on the Quality 
Payment Program Web site: https://qpp.cms.gov/resources/education.
     Year 2: Measures are identified as topped out in the 
benchmarks published for the 2018 MIPS performance period. Measures 
identified in Table 18 have special scoring applied, provided they are 
identified as topped out for the 2018 MIPS performance period, meaning 
it is the second consecutive year they are identified as topped out.
     Year 3: Measures are identified as topped out in the 
benchmarks published for the 2019 MIPS performance period. The measures 
identified as topped out in the benchmarks published for the 2019 MIPS 
performance period and the previous two consecutive performance periods 
would continue to have special scoring applied for the 2019 MIPS 
performance period and would be considered, through notice-and-comment 
rulemaking, for removal for the 2020 MIPS performance period.
     Year 4: Topped out measures that are finalized for removal 
are no longer available for reporting. For example, the measures 
identified as topped out for the 2017, 2018 and 2019 MIPS performance 
periods, if subsequently finalized for removal, will not be available 
on the list of measures for the 2020 MIPS performance period and future 
years. For all other measures, the timeline would apply starting with 
the benchmarks for the 2018 MIPS performance period. Thus, the first 
year any topped out measure other than those identified in Table 18 
could be proposed for removal would be in rulemaking for the 2021 MIPS 
performance period, based on the benchmarks being topped out in the 
2018, 2019, and 2020 MIPS performance periods. If the measure benchmark 
is not topped out for three consecutive MIPS performance periods, then 
the lifecycle would stop and start again at year 1 the next time the 
measure benchmark is topped out.
    An example of applying the proposed scoring cap compared to scoring 
applied for the 2017 MIPS performance period is provided in Table 19.

           Table 19--Scoring for Topped Out Measures * Starting in the CY 2018 MIPS Performance Period Compared to the Transition Year Scoring
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                 Measure 1        Measure 2        Measure 3        Measure 4      Measure 5 (not   Measure 6 (not    Quality category
       Scoring policy           (topped out)     (topped out)     (topped out)     (topped out)     topped out)      topped out)       percent score *
--------------------------------------------------------------------------------------------------------------------------------------------------------
2017 MIPS performance period  10 measure       10 measure       10 measure       4 measure        10 measure       5 measure        49/60 = 81.67
 Scoring.                      achieve-ment     achieve-ment     achieve-ment     achieve-ment     achieve-ment     achieve-ment
                               points.          points.          points.          points (did      points.          points.
                                                                                  not get max
                                                                                  score).
Capped Scoring applied......  7 measure        7 measure        7 measure        4 measure        10 measure       5 measure        40/60 = 66.67.
                               achieve-ment     achieve-ment     achieve-ment     achieve-ment     achieve-ment     achieve-ment
                               points.          points.          points.          points.          points.          points.
                             ------------------------------------------------------------------------------------------------------
Notes.......................  Topped out measures scored with 7-point measure achievement point
                               cap. Cap does not impact score if the MIPS eligible clinician's
                               score is below the cap.
                              Still possible to earn maximum    ...............
                               measure achievement points on
                               the non-topped out measures
--------------------------------------------------------------------------------------------------------------------------------------------------------
* This example would only apply to the 6 measures identified in Table 18 for the CY 2018 MIPS Performance Period. This example also excludes bonus
  points and improvement scoring proposed in section the proposed rule (82 FR 30113 through 30114).

(d) Case Minimum Requirements and Measure Reliability and Validity
    To help ensure reliable measurement, in the CY 2017 Quality Payment 
Program final rule (81 FR 77288), we finalized a 20-case minimum for 
all quality measures except the all-cause hospital readmission measure. 
For the all-cause hospital readmission measure, we finalized in the CY 
2017 Quality Payment Program final rule a 200-case minimum and 
finalized to apply the all-cause hospital readmission measure only to 
groups of 16 or more clinicians that meet the 200-case minimum 
requirement (81 FR 77288). We did not propose any changes to these 
policies.
    For the 2019 MIPS payment year, we finalized in the CY 2017 Quality 
Payment Program final rule that if the measure is submitted but is 
unable to be scored because it does not meet the required case minimum, 
does not have a benchmark, or does not meet the data completeness 
requirement, the measure would receive a score of 3 points (81 FR 77288 
through 77289). We identified two classes of measures for the 
transition year. Class 1 \5\ measures are measures that can be scored 
based on performance because they have a benchmark, meet the case 
minimum requirement, and meet the data completeness standard. We 
finalized that Class 1 measures would receive 3 to 10 points based on 
performance compared to the benchmark (81 FR 77289). Class 2 measures 
are measures that cannot be scored based on performance because they do 
not have a benchmark, do not have at least 20 cases, or the submitted 
measure does not meet data completeness criteria. We

[[Page 53728]]

finalized that Class 2 measures, which do not include measures 
submitted with the CMS Web Interface or administrative claims-based 
measures, receive 3 points (81 FR 77289).
---------------------------------------------------------------------------

    \5\ References to ``Classes'' of measures in this section 
II.C.7.a.(2)(d) of this final rule with comment period are intended 
only to characterize the measures for ease of discussion.
---------------------------------------------------------------------------

    We proposed to maintain the policy to assign 3 points for measures 
that are submitted but do not meet the required case minimum or do not 
have a benchmark for the 2020 MIPS payment year and amend Sec.  
414.1380(b)(1)(vii) accordingly (82 FR 30106 through 30108). We also 
proposed a change to the policy for scoring measures that do not meet 
the data completeness requirement for the 2020 MIPS payment year.
    To encourage complete reporting, we proposed that in the 2020 MIPS 
payment year, measures that do not meet data completeness standards 
will receive 1 point instead of the 3 points that were awarded in the 
2019 MIPS payment year. We proposed lowering the point floor to 1 for 
measures that do not meet data completeness standards for several 
reasons. First, we want to encourage complete reporting because data 
completeness is needed to reliably measure quality. Second, unlike case 
minimum and availability of a benchmark, data completeness is within 
the direct control of the MIPS eligible clinician. In the future, we 
intend that measures that do not meet the completeness criteria will 
receive zero points; however, we believe that during the second year of 
transitioning to MIPS, clinicians should continue to receive at least 1 
measure achievement point for any submitted measure, even if the 
measure does not meet the data completeness standards.
    We are concerned, however, that data completeness may be harder to 
achieve for small practices. Small practices tend to have small case 
volume, and missing one or two cases could cause the MIPS eligible 
clinician to miss the data completeness standard as each case may 
represent multiple percentage points for data completeness. For 
example, for a small practice with only 20 cases for a measure, each 
case is worth 5 percentage points, and if they miss reporting just 11 
or more cases, they would fail to meet the data completeness threshold, 
whereas for a practice with 200 cases, each case is worth 0.5 
percentage points towards data completeness, and the practice would 
have to miss more than 100 cases to fail to meet the data completeness 
criteria. Applying 1 point for missing data completeness based on 
missing a relatively small number of cases could disadvantage small 
practices, which may have additional burdens for reporting in MIPS, 
although we also recognize that failing to report on 10 or more 
patients is undesirable. In addition, we know that many small practices 
may have less experience with submitting quality performance category 
data and may not yet have systems in place to ensure they can meet the 
data completeness criteria. Thus, we proposed an exception to the 
proposed policy for measures submitted by small practices, as defined 
in Sec.  414.1305. We proposed that these clinicians would continue to 
receive 3 points for measures that do not meet data completeness.
    Therefore, we proposed to revise Class 2 measures to include only 
measures that cannot be scored based on performance because they do not 
have a benchmark or do not have at least 20 cases. We also proposed to 
create Class 3 measures, which are measures that do not meet the data 
completeness requirement. We proposed that the revised Class 2 measure 
would continue to receive 3 points. The proposed Class 3 measures would 
receive 1 point, except if the measure is submitted by a small practice 
in which case the Class 3 measure would receive 3 points. However, 
consistent with the policy finalized in the CY 2017 Quality Payment 
Program final rule, these policies for Class 2 and Class 3 measures 
would not apply to measures submitted with the CMS Web Interface or 
administrative claims-based measures. A summary of the proposals is 
provided in Table 20.

                  Table 20--Quality Performance Category: Scoring Measures Based on Performance
----------------------------------------------------------------------------------------------------------------
                                              Scoring rules in 2017   Description for 2018
     Measure type          Description in        MIPS performance       MIPS performance          2018 MIPS
                          transition year             period                 period          performance period
----------------------------------------------------------------------------------------------------------------
Class 1..............  Measures that can be   3 to 10 points based   Same as transition     Same as transition
                        scored based on        on performance         year.                  year.
                        performance.           compared to the                              3 to 10 points based
                        Measures that were     benchmark.                                    on performance
                        submitted or                                                         compared to the
                        calculated that met                                                  benchmark.
                        the following
                        criteria:
                       (1) The measure has a
                        benchmark;.
                       (2) Has at least 20
                        cases; and.
                       (3) Meets the data
                        completeness
                        standard (generally
                        60 percent.).
Class 2..............  Measures that cannot   3 points.............  Measures that were     3 points.
                        be scored based on    * This Class 2          submitted and meet    * This Class 2
                        performance.           measure policy does    data completeness,     measure policy
                        Measures that were     not apply to CMS Web   but do not have both   would not apply to
                        submitted, but fail    Interface measures     of the following:      CMS Web Interface
                        to meet one of the     and administrative    (1) a benchmark......   measures and
                        Class 1 criteria.      claims based          (2) at least 20         administrative
                        The measure either     measures.              cases..                claims based
                       (1) does not have a                                                   measures.
                        benchmark,.
                       (2) does not have at
                        least 20 cases, or.
                       (3) does not meet
                        data completeness
                        criteria..

[[Page 53729]]

 
Class 3..............  n/a..................  n/a..................  Measures that were     1 point except for
                                                                      submitted, but do      small practices,
                                                                      not meet data          which would receive
                                                                      completeness           3 points.
                                                                      criteria, regardless  * This Class 3
                                                                      of whether they have   measure policy
                                                                      a benchmark or meet    would not apply to
                                                                      the case minimum.      CMS Web Interface
                                                                                             measures and
                                                                                             administrative
                                                                                             claims based
                                                                                             measures
----------------------------------------------------------------------------------------------------------------

    The following is a summary of the public comments received on our 
proposal for measures that do not meet the case minimum requirement or 
do not have a benchmark (Class 2 measures) and our responses:
    Comment: A few commenters supported maintaining the policy to 
assign 3 points to measures that are submitted but do not have a 
benchmark or meet the case minimum.
    Response: We appreciate commenters support for the policy to assign 
3 points to Class 2 measures.
    Comment: Several commenters recommended that more than 3 points 
should be assigned to measures without a benchmark, citing the need to 
encourage MIPS eligible clinicians to report new measures and ensure 
adequate representation of quality of care provided. A few commenters 
proposed assigning a null value, maximum points, 6 points, or bonus 
points to these measures. A few commenters suggested measures with no 
benchmarks should have an opportunity to earn a maximum or near maximum 
score or at least 5 or 6 points. One commenter encouraged CMS to align 
general MIPS and the APM scoring standard and suggested that measures 
that do not have a benchmark or meet the case minimum should not be 
removed from the numerator and denominator of the quality performance 
category percent score, regardless of whether general MIPS or the APM 
scoring standard applies.
    Response: We recognize stakeholders' concerns regarding the 
assignment of 3 points to measures without a benchmark. However, 
assigning more than 3 points, a null value, or bonus points increases 
the likelihood of potential gaming because new measures and other 
measures without a benchmark based on the baseline period may still be 
scored based on performance and receive between 3-10 measure 
achievement points if the measure has a benchmark based on the 
performance period (Class 1 measures). Therefore, if we were to use any 
of the suggested approaches, it would be more advantageous for a MIPS 
eligible clinician that submits measures without a benchmark because 
points for those measures would be higher than the floor for Class 1 
measures. For those measures without a benchmark based on the baseline 
period or the performance period (Class 2 measures), we selected 3 
points because we did not want to provide more credit for reporting a 
measure than cannot be reliably scored against a benchmark than for 
measures for which we can measure performance against a benchmark. 
Providing null values would reduce the final quality score potential of 
60 points and may provide incentives for MIPS eligible clinicians to 
submit mostly measures without a benchmark that cannot be reliably 
scored, rather than encouraging the use of measures that can reliably 
measure performance, provide meaningful distinctions and performance 
and offer improvement opportunities. We refer readers to section 
II.C.6.g.(3)(b) of this final rule with comment period for further 
discussion on the quality performance category for MIPS APMs including 
the use of the null value score for measures that do not have a 
benchmark or meet the case minimum. We will continue to monitor the 
impact of the policy as we gain experience with MIPS and evaluate 
whether we need to revisit these approaches in future rulemaking.
    Final Action: After consideration of public comments, we are 
finalizing our proposal to maintain the policy to assign 3 points for 
measures that are submitted but do not meet the required case minimum 
or do not have a benchmark for the 2020 MIPS payment year and amend 
Sec.  414.1380(b)(1)(vii) accordingly.
    We proposed to amend Sec.  414.1380(b)(1)(vii) to assign 3 points 
for measures that do not meet the case minimum or do not have a 
benchmark in the 2020 MIPS payment year, and to assign 1 point for 
measures that do not meet data completeness requirements, unless the 
measure is submitted by a small practice, in which case it would 
receive 3 points (82 FR 30108).
    We invited comment on our proposal to assign 1 point to measures 
that do not meet data completeness criteria, with an exception for 
measures submitted by small practices.
    The following is a summary of the public comments received on the 
data completeness proposal and our responses:
    Comment: Several commenters supported lowering the 3-point floor to 
1 point for measures that do not meet the data completeness criteria 
because it would encourage MIPS eligible clinicians to report more 
complete performance data, in turn supporting the robust measurement 
underlying the Quality Payment Program's overall assessments, bonuses, 
and penalties. One commenter suggested adjusting the points assigned to 
small practices in future years to align with large practices and 
incentivize small practices to collect quality measure data 
effectively. One commenter only supported awarding 1 point if the 
performance period for the quality performance category was not longer 
than 90 days.
    Response: We thank commenters for their support for lowering the 
points assigned to measures that do not meet the data completeness 
criteria from 3 points to 1 point. We will continue to revisit ways to 
improve this policy in future years. Additionally, we believe that it 
would not be in the best interest of MIPS eligible clinicians to have 
less than a full calendar year performance period for the quality 
performance category. We refer readers to section II.C.5. of this final 
rule with comment period for future discussion on the MIPS performance 
period.
    Comment: Several commenters supported CMS's proposed policy to 
assign 3 points to small practices who submit measures that do not meet 
the data completeness requirement. A few commenters requested that CMS 
extend the 3-point floor for small practices past the 2018 MIPS 
performance period or include other types of clinicians or

[[Page 53730]]

groups that may need a similar exception. One commenter who supported 
the small practice exception also expressed concern that it would not 
be enough to overcome the disparities between small and rural practices 
and large and urban practices.
    Response: We thank commenters for their support for the small 
practice exception. We will consider ways to improve this approach in 
future years, including assessing the exception's impact on any 
disparities between various types of practices. Next year we will 
revisit whether to extend the small practice exception beyond the 2018 
MIPS performance period. At this time, we do not believe it is 
appropriate to extend this exception beyond small practices because we 
believe the policy supports our program goals for complete and accurate 
reporting to support meaningful efforts to improve the quality of care 
patients receive.
    Comment: Many commenters did not support assigning 1 point to 
measures that do not meet the data completeness criteria in the 2018 
MIPS performance period and wanted to maintain the policy to assign 3 
points. A few commenters cited the difficulty many practices face in 
meeting the data completeness threshold, including disparate IT 
systems, the dearth of germane specialty quality measures that can be 
reported electronically, and limited numbers of cases. One commenter 
wanted long term stability in the program reporting requirements, 
citing the administrative burden caused by changes. A few commenters 
requested that the 3-point floor remain until there is data to show 
that sufficient numbers of MIPS eligible clinicians are able to meet 
the criteria to warrant a reduction in points or at least until 2015 
CEHRT is required. Another commenter stated that having a different 
floor for small practices creates a disparity in scoring and further 
complicates the Quality Payment Program. One commenter suggested that 
CMS continue to assign 3 points if the MIPS eligible clinician makes a 
substantive effort to submit data, or provide a sliding scale for MIPS 
eligible clinicians who make a good faith effort to achieve data 
completeness thresholds, thus rewarding physicians for submitting data 
in a timely manner.
    Response: We believe assigning 1 point to measures that do not meet 
the data completeness criteria reflects our goals for MIPS eligible 
clinicians' performance under the Quality Payment Program. We also 
believe that data completeness is something that is within a 
clinician's control, and without the data completeness requirement 
clinicians would be able to receive 3 measure achievement points for 
submitting just one case. While that was appropriate for year 1, it is 
less appropriate as we transition into year 2 and future years. As 
discussed in section II.C.6.b.(3)(b) of this final rule with comment 
period, we are not finalizing our proposal to lower the data 
completeness threshold to 50 percent for the 2018 performance period, 
rather it will remain at 60 percent for the 2018 performance period as 
finalized in the CY 2017 Quality Payment Program final rule with 
comment period. While we acknowledge stakeholders' concerns and 
suggestions for delaying the implementation of the 1-point policy, we 
believe this policy supports our program goals for complete and 
accurate reporting that reflects meaningful efforts to improve the 
quality of care patients receive. We will continue to consider ways to 
improve the policy to achieve this aim as we work to stabilize and best 
simplify the program reporting requirements.
    Comment: One commenter suggested that measures that do not meet 
data completeness should receive zero points instead of 1 point because 
it adds less complexity to the Quality Payment Program.
    Response: At this time, we believe assigning 1 point is appropriate 
for the second transition year, as it is a step towards meeting our 
goal for a more accurate assessment of a MIPS eligible clinician's 
performance on the quality measures. We will continue to monitor the 
impact of the policy and evaluate whether we need to apply more 
rigorous standards in future rulemaking.
    Final Action: After consideration of public comments, we are 
finalizing the policy to assign 1 point to measures that do not meet 
data completeness criteria, with an exception for measures submitted by 
small practices, which will receive 3 points, and amend Sec.  
414.1380(b)(1)(vii) accordingly.
    We did not propose to change the methodology we use to score 
measures submitted via the CMS Web Interface that do not meet the case 
minimum, do not have a benchmark, or do not meet the data completeness 
requirement finalized in the CY 2017 Quality Payment Program final rule 
and codified at paragraph (b)(1)(viii) of Sec.  414.1380. We referred 
readers to the discussion at 81 FR 77288 for more details on our 
previously finalized policy. However, we noted that as described in the 
proposed rule (82 FR 30113), we proposed to add that CMS Web Interface 
measures with a benchmark that are redesignated from pay for 
performance to pay for reporting by the Shared Savings Program will not 
be scored. We refer readers to the discussion at section 
II.C.7.a.(2)(h)(ii) of this final rule with comment period for public 
comments related to changes in CMS Web Interface scoring.
    We also did not propose any changes to the policy to not include 
administrative claims measures in the quality performance category 
percent score if the case minimum is not met or if the measure does not 
have a benchmark finalized in the CY 2017 Quality Payment Program final 
rule and codified at paragraph (b)(1)(viii) of Sec.  414.1380. We 
referred readers to the discussion at 81 FR 77288 for more details on 
that policy.
    To clarify the exclusion of measures submitted via the CMS Web 
Interface and based on administrative claims from the policy changes 
proposed to be codified at paragraph (b)(1)(vii) previously, we 
proposed to amend paragraph (b)(1)(vii) to make it subject to paragraph 
(b)(1)(viii), which codifies the exclusion.
    We did not receive public comments on this proposal.
    Final Action: We are finalizing as proposed the technical 
corrections to Sec.  414.1380(b)(1)(vii) related to the exclusion of 
measures submitted via the CMS Web Interface. We refer readers to the 
discussion at section II.C.7.a.(2)(h)(ii) of this final rule with 
comment period for public comments related to changes in CMS Web 
Interface scoring.
(e) Scoring for MIPS Eligible Clinician That Do Not Meet Quality 
Performance Category Criteria
    In the CY 2017 Quality Payment Program final rule, we finalized 
that MIPS eligible clinicians who fail to submit a measure that is 
required to satisfy the quality performance category submission 
criteria would receive zero points for that measure (81 FR 77291). We 
did not propose any changes to the policy to assign zero points for 
failing to submit a measure that is required in this proposed rule.
    We would like to emphasize that MIPS eligible clinicians that fail 
to submit any measures under the quality performance category will 
receive a zero score for this category. All MIPS eligible clinicians 
are required to submit measures under the quality performance category 
unless there are no measures that are applicable and available or 
because of extreme and uncontrollable circumstances. For further 
discussion on extreme and uncontrollable circumstances, see sections 
II.C.7.b.(3)(c) and III.B of this final rule with comment period.

[[Page 53731]]

    In the CY 2017 Quality Payment Program final rule, we also 
finalized implementation of a validation process for claims and 
registry submissions to validate whether MIPS eligible clinicians have 
6 applicable and available measures, whether an outcome measure is 
available or whether another high priority measure is available if an 
outcome measure is not available (81 FR 77290 through 77291).
    We did not propose any changes to the process for validating 
whether MIPS eligible clinicians that submit measures via claims and 
registry submissions have measures available and applicable. We stated 
in the CY 2017 Quality Payment Program final rule (81 FR 77290) that we 
did not intend to establish a validation process for QCDRs because we 
expect that MIPS eligible clinicians that enroll in QCDRs will have 
sufficient meaningful measures to meet the quality performance category 
criteria (81 FR 77290 through 77291). We did not propose any changes to 
this policy.
    We also stated that if a MIPS eligible clinician did not have 6 
measures relevant within their EHR to meet the full specialty set 
requirements or meet the requirement to submit 6 measures, the MIPS 
eligible clinician should select a different submission mechanism to 
meet the quality performance category requirements and should work with 
their EHR vendors to incorporate applicable measures as feasible (81 FR 
77290 through 77291). Under our proposals discussed in section 
II.C.6.a.(1) of this final rule with comment period to allow measures 
to be submitted and scored via multiple mechanisms within a performance 
category, we anticipated that MIPS eligible clinicians that submit 
fewer than 6 measures via EHR will have sufficient additional measures 
available via a combination of submission mechanisms to submit the 
measures required to meet the quality performance category criteria. 
For example, the MIPS eligible clinician could submit 2 measures via 
EHR and supplement that with 4 measures via QCDR or registry.
    Therefore, given the proposal to score multiple mechanisms, if a 
MIPS eligible clinician submits any quality measures via EHR or QCDR, 
we would not conduct a validation process because we expect these MIPS 
eligible clinicians to have sufficient measures available to meet the 
quality performance category requirements. As discussed in section 
II.C.6.a.(1) of this final rule with comment period, we are not 
finalizing the proposal to score multiple mechanisms beginning with the 
CY 2018 performance period as proposed, but instead beginning with the 
CY 2019 performance period.
    Given our proposal to score measures submitted via multiple 
mechanisms (see 82 FR 30110 through 30113), we proposed to validate the 
availability and applicability of measures only if a MIPS eligible 
clinician submits via claims submission options only, registry 
submission options only, or a combination of claims and registry 
submission options. In these cases, we proposed that we will apply the 
validation process to determine if other measures are available and 
applicable broadly across claims and registry submission options. We 
will not check if there are measures available via EHR or QCDR 
submission options for these reporters. We noted that groups cannot 
report via claims, and therefore groups and virtual groups will only 
have validation applied across registries. We would validate the 
availability and applicability of a measure through a clinically 
related measure analysis based on patient type, procedure, or clinical 
action associated with the measure specifications. For us to recognize 
fewer than 6 measures, an individual MIPS eligible clinician must 
submit exclusively using claims or qualified registries or a 
combination of the two, and a group or virtual group must submit 
exclusively using qualified registries. Given the proposal in the 
proposed rule (82 FR 30110 through 30113) to permit scoring measures 
submitted via multiple mechanisms, validation will be conducted first 
by applying the clinically related measure analysis for the individual 
measure, and then, to the extent technically feasible, validation will 
be applied to check for available measures available via both claims 
and registries.
    We would like to clarify that we expect that MIPS eligible 
clinicians would choose a single submission mechanism that would allow 
them to report 6 measures. Multiple submission mechanisms give MIPS 
eligible clinicians additional flexibility in reporting the 6 measures, 
and we do not require using multiple submission mechanisms for 
reporting quality measures.
    The following is a summary of the public comments received on 
validation only if measures are submitted via claims and/or registry 
options proposal and our responses:
    Comment: Several commenters were concerned about the impact of 
multiple submission mechanisms on the validation process for claims and 
registry submissions. A few commenters recommended that the validation 
process should be limited to a single submission mechanism. Several 
commenters were concerned that the process may determine that a MIPS 
eligible clinician who reports via claims should have also reported via 
a qualified registry to reach six measures adding an administrative and 
financial burden for MIPS eligible clinicians. A few commenters also 
recommended that in cases of claims reporting, CMS limit validation to 
measures applicable to claims reporting only or develop a process to 
determine in advance of the reporting year which quality measures are 
likely applicable to each MIPS eligible clinician and only hold them 
accountable for these relevant measures. A few commenters requested 
clarification on the validation process and how it would be implemented 
for measures submitted via claims and registries in light of the 
proposal to use multiple submission mechanisms.
    Response: As mentioned in II.C.6.a.(1) of this final rule with 
comment period, we are finalizing the policy for scoring measures 
submitted via multiple mechanisms beginning with year 3 to allow 
additional time to communicate how this policy intersects with our 
measure applicability policies. To align with that policy, we are 
finalizing our validation proposal with modification beginning with 
year 3 and, for the year 2 validation process, will continue to apply 
the year 1 validation process, which is limited to a single submission 
mechanism. Also, given commenters' concerns regarding the impact of 
multiple submission mechanisms on the validation process for claims and 
registry submissions, we are modifying our validation proposal to 
provide that we will validate the availability and applicability of 
quality measures only with respect to the data submission mechanism(s) 
that a MIPS eligible clinician utilizes for the quality performance 
category for a performance period. We will not apply the validation 
process to any data submission mechanism that the MIPS eligible 
clinician does not utilize for the quality performance category for the 
performance period. Thus, MIPS eligible clinicians who submit quality 
data via claims only would be validated against claims measures only, 
and MIPS eligible clinicians who submit quality data via registry only 
would be validated against registry measures only. MIPS eligible 
clinicians who, beginning with year 3, elect to submit quality data via 
claims and registry would be validated against both claims and registry 
measures; however, they would not be validated against measures 
submitted via other

[[Page 53732]]

data submission mechanisms. Thus, under the modified validation 
process, MIPS eligible clinicians who submit via claims or registry 
submission only or a combination of claims and registry submissions 
would not be required to submit measures through multiple mechanisms to 
meet the quality performance category criteria; rather, utilizing 
multiple submission mechanisms is an option available to MIPS eligible 
clinicians beginning with year 3, which may increase their quality 
performance category score, but may also affect the scope of measures 
against which they will be validated or whether they qualify for the 
validation process. We expect that MIPS eligible clinicians would 
choose a single submission mechanism that would allow them to report 6 
measures. Our intention is to offer multiple submission mechanisms to 
increase flexibility for MIPS individual clinicians and groups. We are 
not requiring that MIPS individual clinicians and groups submit via 
multiple submission mechanisms; however, beginning with year 3, the 
option would be available for those that have applicable measures and/
or activities available to them.
    Comment: A few commenters recommended a validation process for 
measures submitted via EHR and QCDR reporting mechanisms to ensure that 
eligible clinicians who select an EHR or QCDR mechanism to report are 
not unfairly disadvantaged. The commenters believed that such 
clinicians may not have 6 relevant measures to report; therefore, a 
lack of a validation process for QCDR and EHR reporting disincentivizes 
QCDR- and EHR-based submission of quality measures.
    Response: As we mentioned in the proposed rule (82 FR 30108 through 
30109), we expect that MIPS eligible clinicians that enroll in QCDRs 
should have sufficient measures to report and that those who submit via 
EHR and do not have a sufficient number of measures within their EHR 
should select a different submission mechanism to meet the quality 
performance category requirements and should work with their EHR 
vendors to incorporate applicable measures as feasible. We recognize 
this may be a disadvantage for MIPS eligible clinicians who submit via 
EHR in year 2; however, beginning in the 2019 MIPS performance period, 
MIPS eligible clinicians that submit fewer than 6 measures via EHR will 
have sufficient additional measures available via a combination of 
submission mechanisms to meet the 6-measure reporting requirement. We 
strongly encourage MIPS eligible clinicians to select the submission 
mechanism that has 6 measures available and applicable to their 
specialty and practice type. The multiple submission policy will help 
situations where people who do not have 6 measures via the QCDR or EHR, 
would have the ability to report via QCDR or EHR and supplement 
measures from other mechanisms.
    Final Action: After consideration of public comments, we are 
finalizing our validation proposal with modification beginning with 
year 3 (CY 2019 performance period and 2021 MIPS payment year). For 
year 2 (CY 2018 performance period and 2020 MIPS payment year), we will 
continue to apply the year 1 validation process. As discussed above, we 
are modifying our validation proposal to provide that we will validate 
the availability and applicability of quality measures only with 
respect to the data submission mechanism(s) that a MIPS eligible 
clinician utilizes for the quality performance category for a 
performance period. We will not apply the validation process to any 
data submission mechanism that the MIPS eligible clinician does not 
utilize for the quality performance category for the performance 
period. We seek comment on how to modify the validation process for 
year 3 when we have multiple submission mechanisms.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30109), 
we recognized that in extremely rare instances there may be a MIPS 
eligible clinician who may not have available and applicable quality 
measures. For example, a subspecialist who focuses on a very targeted 
clinical area may not have any measures available. However, in many 
cases, the clinician may be part of a broader group or would have the 
ability to select some of the cross-cutting measures that are 
available. Given the wide array of submission options, including QCDRs 
which have the flexibility to develop additional measures, we believe 
this scenario should be extremely rare. If we are not able to score the 
quality performance category, we may reweight their score according to 
the reweighting policies described in section II.C.7.b.(3)(b) and 
II.C.7.b.(3)(d) of this final rule with comment period. We noted that 
we anticipate this will be a rare circumstance given our proposals to 
allow measures to be submitted and scored via multiple mechanisms 
within a performance category and to allow facility-based measurement 
for the quality performance category.
(f) Incentives To Report High Priority Measures
    In the CY 2017 Quality Payment Program final rule, we finalized 
that we would award 2 bonus points for each outcome or patient 
experience measure and 1 bonus point for each additional high priority 
measure that is reported in addition to the 1 high priority measure 
that is already required to be reported under the quality performance 
category submission criteria, provided the measure has a performance 
rate greater than zero, and the measure meets the case minimum and data 
completeness requirements (81 FR 77293). High priority measures were 
defined as outcome, appropriate use, patient safety, efficiency, 
patient experience and care coordination measures. We also finalized 
that we will apply measure bonus points for the CMS Web Interface for 
the Quality Payment Program based on the finalized set of measures 
reportable through that submission mechanism (81 FR 77293). We noted 
that in addition to the 14 required measures, CMS Web Interface 
reporters may also report the CAHPS for MIPS survey and receive measure 
bonus points for submitting that measure. We did not propose any 
changes to these policies for awarding measure bonus points for 
reporting high priority measures in the proposed rule.
    In the CY 2017 Quality Payment Program final rule, we finalized a 
cap on high priority measure bonus points at 10 percent of the 
denominator (total possible measure achievement points the MIPS 
eligible clinician could receive in the quality performance category) 
of the quality performance category for the first 2 years of MIPS (81 
FR 77294). We did not propose any changes to the cap on measure bonus 
points for reporting high priority measures, which is codified at Sec.  
414.1380(b)(1)(xiv)(D),\6\ in the proposed rule.
---------------------------------------------------------------------------

    \6\ Redesignated from Sec.  414.1380(b)(1)(xiii)(D).
---------------------------------------------------------------------------

(g) Incentives To Use CEHRT To Support Quality Performance Category 
Submissions
    Section 1848(q)(5)(B)(ii) of the Act outlines specific scoring 
rules to encourage the use of CEHRT under the quality performance 
category. For more of the statutory background and description of the 
proposed and finalized policies, we referred readers to the CY 2017 
Quality Payment Program final rule (81 FR 77294 through 77299).
    In the CY 2017 Quality Payment Program final rule at Sec.  
414.1380(b)(1)(xiv), we codified that 1 bonus point is available for 
each quality

[[Page 53733]]

measure submitted with end-to-end electronic reporting, under certain 
criteria described below (81 FR 77297). We also finalized a policy 
capping the number of bonus points available for electronic end-to-end 
reporting at 10 percent of the denominator of the quality performance 
category percent score, for the first 2 years of the program (81 FR 
77297). We also finalized that the CEHRT bonus would be available to 
all submission mechanisms except claims submissions. Specifically, MIPS 
eligible clinicians who report via qualified registries, QCDRs, EHR 
submission mechanisms, or the CMS Web Interface for the Quality Payment 
Program, in a manner that meets the end-to-end reporting requirements, 
may receive 1 bonus point for each reported measure with a cap (81 FR 
77297).
    We did not propose changes to these policies related to bonus 
points for using CEHRT for end-to-end reporting in the proposed rule. 
However, we sought comment on the use of health IT in quality 
measurement and how HHS can encourage the use of certified EHR 
technology in quality measurement as established in the statute (82 FR 
30109 through 30110).
    We thank commenters for their response on the use of health IT in 
quality measurement and we will consider them in future rulemaking.
(h) Calculating Total Measure Achievement and Measure Bonus Points
    In the proposed rule (82 FR 30113 through 30120), we proposed a new 
methodology to reward improvement based on achievement, from 1 year to 
another, which requires modifying the calculation of the quality 
performance category percent score. In the proposed rule (82 FR 30110 
through 30113), we summarized the policies for calculating the total 
measure achievement points and total measure bonus points, prior to 
scoring improvement and the final quality performance category percent 
score. We noted that we will refer to policies finalized in the CY 2017 
Quality Payment Program final rule that apply to the quality 
performance category score, which is referred to as the quality 
performance category percent score in this proposed rule, in this 
section. We also proposed some refinements to address the ability for 
MIPS eligible clinicians to submit quality data via multiple submission 
mechanisms.
(i) Calculating Total Measure Achievement and Measure Bonus Points for 
Non-CMS Web Interface Reporters
    In the CY 2017 Quality Payment Program final rule (81 FR 77300), we 
finalized that if a MIPS eligible clinician elects to report more than 
the minimum number of measures to meet the MIPS quality performance 
category criteria, then we will only include the scores for the 
measures with the highest number of assigned points, once the first 
outcome measure is scored, or if an outcome measure is not available, 
once another high priority measure is scored. We did not propose any 
changes to the policy to score the measures with the highest number of 
assigned points in this proposed rule; however, we proposed refinements 
to account for measures being submitted across multiple submission 
mechanisms.
    In the CY 2017 Quality Payment Program final rule, we sought 
comment on whether to score measures submitted across multiple 
submission mechanisms (81 FR 77275) and on what approach we should use 
to combine the scores for quality measures from multiple submission 
mechanisms into a single aggregate score for the quality performance 
category (81 FR 77275). We summarized the comments that were received 
in the proposed rule (82 FR 30110).
    We proposed, beginning with the 2018 MIPS performance period, a 
method to score quality measures if a MIPS eligible clinician submits 
measures via more than one of the following submission mechanisms: 
Claims, qualified registry, EHR or QCDR submission options. We noted 
that we believe that allowing MIPS eligible clinicians to be scored 
across these data submission mechanisms in the quality performance 
category will provide additional options for MIPS eligible clinicians 
to report the measures required to meet the quality performance 
category criteria, and encourage MIPS eligible clinicians to begin 
using electronic submission mechanisms, even if they may not have 6 
measures to report via a single electronic submission mechanism alone. 
We noted that we also continue to score the CMS-approved survey vendor 
for CAHPS for MIPS submission options in conjunction with other 
submission mechanisms (81 FR 77275) as noted in Table 21.
    We proposed to score measures across multiple mechanisms using the 
following rules:
     As with the rest of MIPS, we will only score measures 
within a single identifier. For example, as codified in Sec.  
414.1310(e), eligible clinicians and MIPS eligible clinicians within a 
group aggregate their performance data across the TIN in order for 
their performance to be assessed as a group. Therefore, measures can 
only be scored across multiple mechanisms if reported by the same 
individual MIPS eligible clinician, group, virtual group or APM Entity, 
as described in Table 21.
     We did not propose to aggregate measure results across 
different submitters to create a single score for an individual measure 
(for example, we are not going to aggregate scores from different TINs 
within a virtual group TIN to create a single virtual group score for 
the measures; rather, virtual groups must perform that aggregation 
across TINs prior to data submission to CMS). Virtual groups are 
treated like other groups and must report all of their measures at the 
virtual group level, for the measures to be scored. Data completeness 
and all the other criteria will be evaluated at the virtual group 
level. Then the same rules apply for selecting which measures are used 
for scoring. In other words, if a virtual group representative submits 
some measures via a qualified registry and other measures via EHR, but 
an individual TIN within the virtual group also submits measures, we 
will only use the scores from the measures that were submitted at the 
virtual group level, because the TIN submission does not use the 
virtual group identifier. This is consistent with our other scoring 
principles, where, for virtual groups, all quality measures are scored 
at the virtual group level.
     Separately, as also described in Table 21, because CMS Web 
Interface and facility-based measurement each have a comprehensive set 
of measures that meet the proposed MIPS submission requirements, we did 
not propose to combine CMS Web Interface measures or facility-based 
measurement with other group submission mechanisms (other than CAHPS 
for MIPS, which can be submitted in conjunction with the CMS Web 
Interface). We refer readers to section II.C.7.a.(2)(h)(ii) of this 
final rule with comment period for discussion of calculating the total 
measure achievement and measure bonus points for CMS Web Interface 
reporters. We refer readers to section II.C.7.a.(4) of the final rule 
with comment period for a description of our policies on facility-based 
measurement. We list these submission mechanisms in Table 21, to 
illustrate that CMS Web Interface submissions and facility-based 
measurement cannot be combined with other submission options, except 
that the CAHPS for MIPS survey can be combined with CMS Web Interface, 
as described in the proposed rule (82 FR 30113).

[[Page 53734]]



   Table 21--Scoring Allowed Across Multiple Mechanisms by Submission
                                Mechanism
      [Determined by MIPS identifier and submission mechanism] \1\
------------------------------------------------------------------------
                                           When can quality measures be
     MIPS identifier and submission           scored across multiple
               mechanisms                          mechanisms?
------------------------------------------------------------------------
Individual eligible clinician reporting  Can combine claims, EHR, QCDR,
 via claims, EHR, QCDR, and registry      and registry.
 submission options.
Group reporting via EHR, QCDR,           Can combine EHR, QCDR,
 registry, and the CAHPS for MIPS         registry, and CAHPS for MIPS
 survey.                                  survey.
Virtual group reporting via EHR, QCDR,   Can combine EHR, QCDR,
 registry, and the CAHPS for MIPS         registry, and CAHPS for MIPS
 survey.                                  survey.
Group reporting via CMS Web Interface..  Cannot be combined with other
                                          submission mechanisms, except
                                          for the CAHPS for MIPS survey.
Virtual group reporting via CMS Web      Cannot be combined with other
 Interface.                               submission mechanisms, except
                                          for the CAHPS for MIPS survey.
Individual or group reporting facility-  Cannot be combined with other
 based measures.                          submission mechanisms.
MIPS APMs reporting Web Interface or     MIPS APMs are subject to
 other quality measures.                  separate scoring standards and
                                          cannot be combined with other
                                          submission mechanisms.
------------------------------------------------------------------------
\1\ The all-cause readmission measure is not submitted and applies to
  all groups of 16 or more clinicians who meet the case minimum of 200.

     If a MIPS eligible clinician submits the same measure via 
2 different submission mechanisms, we will score each mechanism by 
which the measure is submitted for achievement and take the highest 
measure achievement points of the 2 mechanisms.
     Measure bonus points for high priority measures would be 
added for all measures submitted via all the different submission 
mechanisms available, even if more than 6 measures are submitted, but 
high priority measure bonus points are only available once for each 
unique measure (as noted by the measure number) that meets the criteria 
for earning the bonus point. For example, if a MIPS eligible clinician 
submits 8 measures--6 process and 2 outcome--and both outcome measures 
meet the criteria for a high priority bonus (meeting the required data 
completeness, case minimum, and has a performance rate greater than 
zero), the outcome measure with the highest measure achievement points 
would be scored as the required outcome measure and then the measures 
with the next 5 highest measure achievement points will contribute to 
the final quality score. This could include the second outcome measure 
but does not have to. Even if the measure achievement points for the 
second outcome measure are not part of the quality performance category 
percent score, measure bonus points would still be available for 
submitting a second outcome measure and meeting the requirement for the 
high priority measure bonus points. The rationale for providing measure 
bonus points for measures that do not contribute measure achievement 
points to the quality performance category percent score is that it 
would help create better benchmarks for outcome and other high priority 
measures by encouraging clinicians to report them even if they may not 
have high performance on the measure. We also want to encourage MIPS 
eligible clinicians to submit to us all of their available MIPS data, 
not only the data that they or their intermediary deem to be their best 
data. We believe it will be in the best interest of all MIPS eligible 
clinicians that we determine which measures will result in the 
clinician receiving the highest MIPS score. If the same measure is 
submitted through multiple submission mechanisms, we would apply the 
bonus points only once to the measure. We proposed to amend Sec.  
414.1380(b)(1)(xiv) (as redesignated from Sec.  414.1380(b)(1)(xiii)) 
to add paragraph (b)(1)(xiv)(E) that if the same high priority measure 
is submitted via two or more submission mechanisms, as determined using 
the measure ID, the measure will receive high priority measure bonus 
points only once for the measure. The total measure bonus points for 
high-priority measures would still be capped at 10 percent of the total 
possible measure achievement points.
     Measure bonus points that are available for the use of 
end-to-end electronic reporting would be calculated for all submitted 
measures across all submission mechanisms, including measures that 
cannot be reliably scored against a benchmark. If the same measure is 
submitted through multiple submission mechanisms, then we would apply 
the bonus points only once to the measure. For example, if the same 
measure is submitted using end-to-end reporting via both a QCDR and EHR 
reporting mechanism, the measure would only get a measure bonus point 
one time. We proposed to amend Sec.  414.1380(b)(1)(xv) (as 
redesignated) to add that if the same measure is submitted via two or 
more submission mechanisms, as determined using the measure ID, the 
measure will receive measure bonus points only once for the measure. 
The total measure bonus points for end-to-end electronic reporting 
would still be capped at 10 percent of the total available measure 
achievement points.
    Although we provided a policy to account for scoring in those 
circumstances when the same measure is submitted via multiple 
mechanisms, we anticipated that this will be a rare circumstance and do 
not encourage clinicians to submit the same measure via multiple 
mechanisms. Table 22 illustrates how we would assign total measure 
achievement points and total measure bonus points across multiple 
submission mechanisms under the proposal. In this example, a MIPS 
eligible clinician elects to submit quality data via 3 submission 
mechanisms: 3 measures via registry, 4 measures via claims, and 5 
measures via EHR. The 3 registry measures are also submitted via claims 
(as noted by the same measure letter in this example). The EHR measures 
do not overlap with either the registry or claims measures. In this 
example, we assign measure achievement and bonus points for each 
measure. If the same measure (as determined by measure ID) is 
submitted, then we use the highest achievement points for that measure. 
For the bonus points, we assess which of the outcome measures meets the 
outcome measure requirement and then we identify any other unique 
measures that qualify for the high priority bonus. We also identify the 
unique measures that qualify for end-to-end electronic reporting bonus.

[[Page 53735]]



    Table 22--Example of Assigning Total Measure Achievement and Bonus Points for an Individual MIPS Eligible
                      Clinician That Submits Measures Across Multiple Submission Mechanisms
----------------------------------------------------------------------------------------------------------------
                                     Measure                           High priority
                                   achievement         6 scored        measure bonus      Incentive for CEHRT
                                      points           measures           points          measure bonus points
----------------------------------------------------------------------------------------------------------------
Registry:
    Measure A (Outcome).......  7.1..............  7.1 (Outcome      (required
                                                    measure with      outcome measure
                                                    highest           does not
                                                    achievement       receive bonus
                                                    points).          points).
    Measure B.................  6.2 (points not
                                 considered
                                 because it is
                                 lower than the
                                 8.2 points for
                                 the same claims
                                 measure).
    Measure C (high priority    5.1 (points not    ................  1...............
     patient safety measure      considered
     that meets requirements     because it is
     for additional bonus        lower than the
     points).                    6.0 points for
                                 the same claims
                                 measure).
----------------------------------------------------------------------------------------------------------------
Claims:
    Measure A (Outcome).......  4.1 (points not    ................  No bonus points
                                 considered                           because the
                                 because it is                        registry
                                 lower than the                       submission of
                                 7.1 points for                       the same
                                 the same measure                     measure
                                 submitted via a                      satisfies
                                 registry).                           requirement for
                                                                      outcome measure.
    Measure B.................  8.2..............  8.2.............
    Measure C (High priority    6.0..............  6.0.............  No bonus (Bonus
     patient safety measure                                           applied to the
     that meets requirements                                          registry
     for additional bonus                                             measure).
     points).
    Measure D (outcome measure  1.0 \2\..........  ................  (no high
     <50% of data submitted).                                         priority bonus
                                                                      points because
                                                                      below data
                                                                      completeness).
----------------------------------------------------------------------------------------------------------------
    EHR (using end-to-end)                                                             Reporting that meets
                                                                                        CEHRT bonus point
                                                                                        criteria
----------------------------------------------------------------------------------------------------------------
Measure E.....................  5.1..............  5.1.............  ................  1.
Measure F.....................  5.0..............  5.0.............  ................  1.
Measure G.....................  4.1..............  ................  ................  1.
Measure H.....................  4.2..............  4.2.............  ................  1.
Measure I (high priority        3.0..............  ................  (no high          1.
 patient safety measure that                                          priority bonus
 is below case minimum).                                              points because
                                                                      below case
                                                                      minimum).
                                                  --------------------------------------------------------------
                                                   35.6............  1 (below 10% cap  5 (below 10% cap).
                                                                      \1\).
                                                  --------------------------------------------------------------
Quality Performance Category    .................                    (35.6 + 1 + 5)/60 = 69.33%
 Percent Score Prior to
 Improvement Scoring.
----------------------------------------------------------------------------------------------------------------
\1\ In this example the cap would be 6 points, which is 10 percent of the total available measure achievement
  points of 60.
\2\ This table in the CY 2018 Quality Payment Program proposed rule (82 FR 30112) inadvertently indicated that
  this would contribute 1 point to the quality performance category percent score for being one of the 6
  measures submitted. In the example, more than 6 measures were submitted and the 6 with the highest scores
  would be used, therefore, Measure D would not contribute points to the final score.

    We proposed to amend Sec.  414.1380(b)(1)(xii) to add paragraph (A) 
to state that if a MIPS eligible clinician submits measures via claims, 
qualified registry, EHR, or QCDR submission options, and submits more 
than the required number of measures, they are scored on the required 
measures with the highest assigned measure achievement points. MIPS 
eligible clinicians that report a measure via more than 1 submission 
mechanism can be scored on only 1 submission mechanism, which will be 
the submission mechanism with the highest measure achievement points. 
Groups that submit via these submission mechanisms may also submit and 
be scored on CMS-approved survey vendor for CAHPS for MIPS submission 
mechanisms.
    We invited comments on the proposal to calculate the total measure 
achievement points by using the measures with the 6 highest measure 
achievement points across multiple submission mechanisms. We invited 
comments on the proposal that if the same measure is submitted via 2 or 
more mechanisms, we will only take the one with the highest measure 
achievement points. We invited comments on the proposal to assign high 
priority measure bonus points to all measures, with performance greater 
than zero, that meet case minimums, and that meet data completeness 
requirements, regardless of submission mechanism and to assign measure 
bonus points for each unique measure submitted using end-to-end 
electronic reporting. We invited comments on the proposal that if the 
same measure is submitted using 2 different mechanisms, the measure 
will receive measure bonus points once.
    We did not propose any changes to our policy that if a MIPS 
eligible clinician does not have any scored measures, then a quality 
performance category percent score will not be calculated as finalized 
in the CY 2017 Quality Payment Program final rule at 81 FR 77300. We 
referred readers to the discussion at 81 FR 77299 through 77300 for 
more details on that policy. We noted in the proposed rule (82 FR 30108 
through 30109) that we anticipate that it will be only in rare case 
that a MIPS eligible clinician does not have any scored measures and a 
quality performance category percent score cannot be calculated.
    The following is a summary of the public comments received on

[[Page 53736]]

calculating total achievement and bonus points when using multiple 
submission mechanisms proposals and our responses:
    Comment: A few commenters supported the policy to assign high 
priority measures bonus points to all measures, with performance 
greater than zero, that meet case minimum, and that meet data 
completeness requirement and to assign measure bonus points for each 
unique measure using end-to-end electronic reporting. One commenter 
expressed support for bonus points, agreeing with CMS that this would 
aid future benchmark development. Another commenter stated that the 
policy offers the best opportunities for eligible clinicians to perform 
well and maximize the bonus points offered.
    Response: As discussed in section II.C.6.a.(1) of this final rule 
with comment period, we are not finalizing the proposal to score 
multiple mechanisms beginning with the CY 2018 performance period as 
proposed, but instead beginning with the CY 2019 performance period. To 
align with that policy, we are not finalizing for the CY 2018 
performance period the policy for calculating total achievement points 
and bonus points when using multiple submission mechanisms, but we are 
finalizing it for the CY 2019 performance period and future. We will 
continue to review this policy in future rulemaking.
    Comment: Several commenters supported taking the highest measure 
achievement point if the same measure is submitted via 2 or more 
mechanisms. A few commenters stated that this offers MIPS eligible 
clinicians the best opportunity to perform well and eliminates the risk 
that a MIPS eligible clinician will be penalized for reporting the same 
measure via multiple mechanisms. Another commenter remarked that CMS is 
providing a necessary transition to more robust submission mechanism 
reporting. One commenter who supported the policy also requested that 
CMS include in provider feedback reports eligible clinicians' scores on 
all measures reported via multiple submission mechanisms to help MIPS 
eligible clinicians select submission mechanisms in future reporting 
periods.
    Response: As noted above, we are finalizing the implementation of 
this policy for the 2019 MIPS performance period and future years to 
align with the multiple submission mechanisms policy and so that 
stakeholders can more fully understand the impact of multiple 
submissions on the measure applicability policies. We will consider 
ways to provide more information on the impact of the policy on quality 
measure scoring, including through provider feedback reports. We refer 
readers to section II.C.6.a.(1) of this final rule with comment period 
for more discussion on the delay.
    Comment: A few commenters did not support the scoring policy for 
measures submitted through multiple submission mechanisms. One 
commenter cited uncertainty in the administration of the policy and 
recommended it not be instituted until CMS can demonstrate the ability 
to receive data and send feedback in a timely and accurate manner. 
Another commenter requested that CMS re-evaluate its scoring policies 
for the affected MIPS eligible clinicians who do not have the 
opportunity to achieve bonus points or take advantage of this policy 
due to measure scarcity. One commenter also expressed concerns that 
potential cross-over measures (that is, measures that can be reported 
through multiple submission mechanisms) limit the ability to aggregate 
the data and shared concerns regarding how MIPS eligible clinicians 
would track their progress across multiple platforms. One commenter was 
concerned about the difficulty in calculating a quality performance 
category score via multiple submission mechanisms. Another expressed 
concern about how the same measure submitted through two different 
submission mechanisms, during different timeframes would be calculated 
and scored. The commenter stated that calculating a score for half of 
the year using one submission mechanism would not be fair, given the 
MIPS eligible clinician reported for the entire year and it would be 
important to rectify as longer reporting durations are mandatory. One 
commenter who supported the policy expressed concern about the number 
of MIPS eligible clinicians who would need to submit via multiple 
mechanisms because of the limited number of specialty measure sets that 
can be reported electronically.
    Response: We understand the commenters' concerns with regards to 
burden and complexity around the use of multiple submission mechanisms. 
We believe that allowing MIPS eligible clinicians to be scored across 
multiple submission mechanisms will provide additional options for MIPS 
eligible clinicians to meet the quality performance category 
requirement, thus maximizing their ability to achieve the highest 
possible score and encouraging them to use electronic reporting. We 
would like to clarify that for performance periods beginning in 2019, 
if a MIPS eligible clinician or group reports for the quality 
performance category by using multiple EHRs then all the submissions 
would be scored and the quality measures with the highest performance 
would be utilized for the quality performance category score. If the 
same measure is reported through multiple submission mechanisms for the 
same performance period, then each submission would be scored, and only 
the highest scored submission would be applied. We would not aggregate 
multiple submissions of the same measure towards the quality 
performance category score. However, we do not anticipate clinicians 
will want to submit the same measure through multiple submission 
mechanisms. As discussed in section II.C.6.a.(1) of this final rule 
with comment period, we are not finalizing the proposed multiple data 
submission mechanisms policy beginning with the CY 2018 performance 
period as proposed, but instead beginning with the CY 2019 performance 
period. The capabilities will be in place for us to administer the 
policy for CY 2019 performance period. We do not believe that MIPS 
eligible clinicians who have a scarcity of measures will be 
disadvantaged because of the validation process discussed in section 
II.C.7.a.(2)(e) of this final rule with comment period would adjust the 
scoring for lack of measures. We refer readers to section II.C.6.a.(1) 
of this final rule with comment period for further discussion on the 
multiple submission mechanism policy, including specialists who report 
on a specialty set or do not have 6 measures to report. Over the next 
year, we intend to work with and educate stakeholders regarding this 
change and make them aware of any potential advantages or disadvantages 
of this policy and discuss how MIPS eligible clinicians who participate 
in this policy can receive feedback.
    Final Action: After consideration of public comments, we are 
finalizing our proposal to calculate the total measure achievement and 
bonus points when using multiple submission mechanisms proposals for 
year 3 to align with the multiple submission mechanisms policy which 
will be finalized for year 3 and amend Sec.  414.1380(b)(1)(xii) 
accordingly.
(ii) Calculating Total Measure Achievement and Measure Bonus Points for 
CMS Web Interface Reporters
    In the CY 2017 Quality Payment Program final rule, we finalized 
that CMS Web Interface reporters are required to report 14 measures, 13 
individual measures, and a 2-component measure for diabetes (81 FR 
77302 through 77305). We noted that for

[[Page 53737]]

the transition year, 3 measures did not have a benchmark in the Shared 
Savings Program. Therefore, for the transition year, CMS Web Interface 
reporters are scored on 11 of the total 14 required measures, provided 
that they report all 14 required measures.
    In the CY 2017 Quality Payment Program final rule, we finalized a 
global floor of 3 points for all CMS Web Interface measures submitted 
in the transition year, even with measures at zero percent performance 
rate, provided that these measures have met the data completeness 
criteria, have a benchmark and meet the case minimum requirements (82 
FR 77305). Therefore, measures with performance below the 30th 
percentile will be assigned a value of 3 points during the transition 
year to be consistent with the floor established for other measures and 
because the Shared Savings Program does not publish benchmarks below 
the 30th percentile (82 FR 77305). We stated that we will reassess 
scoring for measures below the 30th percentile in future years.
    We proposed to continue to assign 3 points for measures with 
performance below the 30th percentile, provided the measure meets data 
completeness, has a benchmark, and meets the case minimum requirements 
for the 2018 MIPS performance year; we made this proposal in order to 
continue to align with the 3-point floor for other measures and because 
the Shared Savings Program does not publish benchmarks with values 
below the 30th percentile (82 FR 30113). We will reassess this policy 
again next year through rulemaking.
    We did not propose any changes to our previously finalized policy 
to exclude from scoring CMS Web Interface measures that are submitted 
but that do not meet the case minimum requirement or that lack a 
benchmark, or to our policy that measures that are not submitted and 
measures submitted below the data completeness requirements will 
receive a zero score (82 FR 77305). However, to further increase 
alignment with the Shared Savings Program, we proposed to also exclude 
CMS Web Interface measures from scoring if the measure is redesignated 
from pay for performance to pay for reporting for all Shared Savings 
Program ACOs, although we will recognize the measure was submitted. 
While the Shared Savings Program designates measures that are pay for 
performance in advance of the reporting year, the Shared Savings 
Program may redesignate a measure as pay for reporting under certain 
circumstances (see 42 CFR 425.502(a)(5)). Therefore, we proposed to 
amend Sec.  414.1380(b)(1)(viii) to add that CMS Web Interface measures 
that have a measure benchmark but are redesignated as pay for reporting 
for all Shared Savings Program ACOs by the Shared Savings Program will 
not be scored, as long as the data completeness requirement is met.
    We invited comment on our proposal to not score CMS Web Interface 
measures redesignated as pay for reporting by the Shared Savings 
Program.
    We also noted that, while we did not state explicitly in the CY 
2017 Quality Payment Program final rule, groups that choose to report 
quality measures via the CMS Web Interface may, in addition to the 14 
required measures, also submit the CAHPS for MIPS survey in the quality 
performance category (81 FR 77094 through 77095; 81 FR 77292). If they 
do so, they can receive bonus points for submitting this high priority 
measure and will be scored on it as an additional measure. Therefore, 
we proposed to amend Sec.  414.1380(b)(1)(xii) to add paragraph (B) to 
state that groups that submit measures via the CMS Web Interface may 
also submit and be scored on CMS-approved survey vendor for CAHPS for 
MIPS submission options.
    In addition, groups of 16 or more eligible clinicians that meet the 
case minimum for administrative claims measures will automatically be 
scored on the all-cause hospital readmission measure and have that 
measure score included in their quality category performance percent 
score.
    We did not propose any changes to calculating the total measure 
achievement points and measure bonus points for CMS Web Interface 
measures in the proposed rule, although we proposed to add improvement 
to the quality performance category percent score for such submissions 
(as well as other submission mechanisms) in the proposed rule (82 FR 
30119 through FR 30120).
    The following is a summary of the public comments received on the 
scoring for CMS Web Interface proposal and our responses:
    Comment: A few commenters supported not scoring CMS Web Interface 
measures re-designated as pay for reporting by the Shared Savings 
Program, citing the need for alignment across programs and consistency 
with the goals of the Quality Payment Program. One commenter requested 
that CMS clarify which pay for reporting measures will be excluded from 
MIPS Quality Performance category scoring.
    Response: We appreciate commenters support for our proposal to not 
score CMS Web Interface measures redesignated as pay for reporting by 
the Shared Savings Program. We will communicate with registered CMS Web 
Interface participants about the re-designation and the changes will be 
posted on a CMS Web site.
    Final Action: After consideration of public comments, we are 
finalizing our proposal to not score CMS Web Interface measures 
redesignated as pay for reporting by the Shared Savings Program and to 
amend Sec.  414.1380(b)(1)(viii) accordingly.
(i) Scoring Improvement for the MIPS Quality Performance Category 
Percent Score
(i) Calculating Improvement at the Quality Performance Category Level
    In the CY 2017 Quality Payment Program final rule, we noted that we 
consider achievement to mean how a MIPS eligible clinician performs 
relative to performance standards, and improvement to mean how a MIPS 
eligible clinician performs compared to the MIPS eligible clinician's 
own previous performance on measures and activities in the performance 
category (81 FR 77274). We also solicited public comments in the CY 
2017 Quality Payment Program proposed rule on potential ways to 
incorporate improvement in the scoring methodology. In the CY 2018 
Quality Payment Program proposed rule (82 FR 30096 through 30098), we 
explained why we believe that the options set forth in the CY 2017 
Quality Payment Program proposed rule, including the Hospital VBP 
Program, the Shared Savings Program, and Medicare Advantage 5-star 
Ratings Program, were not fully translatable to MIPS. Beginning with 
the 2018 MIPS performance period, we proposed to score improvement, as 
well as achievement in the quality performance category level when data 
is sufficient (82 FR 30113 through 30114). We believe that scoring 
improvement at the performance category level, rather than measuring 
improvement at the measure level, for the quality performance category 
would allow improvement to be available to the broadest number of MIPS 
eligible clinicians because we are connecting performance to previous 
MIPS quality performance as a whole rather than changes in performance 
for individual measures. Just as we believe it is important for a MIPS 
eligible clinician to have the flexibility to choose measures that are 
meaningful to their practice, we want them to be able to adopt new 
measures without concern about losing the ability to be measured

[[Page 53738]]

on improvement. In addition, we encouraged MIPS eligible clinicians to 
select more outcome measures and to move away from topped out measures. 
We did not want to remove the opportunity to score improvement from 
those who select different measures between performance periods for the 
quality performance category; therefore, we proposed to measure 
improvement at the category level which can be calculated with 
different measures.
    We proposed at Sec.  414.1380(b)(1)(xvi)(E) to define an 
improvement percent score to mean the score that represents improvement 
for the purposes of calculating the quality performance category 
percent score. We also proposed at Sec.  414.1380(b)(1)(xvi)(C) that an 
improvement percent score would be assessed at the quality performance 
category level and included in the calculation of the quality 
performance category percent score. When we evaluated different 
improvement scoring options, we saw two general methods for 
incorporating improvement. One method measures both achievement and 
improvement and takes the higher of the two scores for each measure 
that is compared. The Hospital VBP Program incorporates such a 
methodology. The second method is to calculate an achievement score and 
then add an improvement score if improvement is measured. The Shared 
Savings Program utilizes a similar methodology for measuring 
improvement. For the quality performance category, we proposed to 
calculate improvement at the category level and believe adding 
improvement to an existing achievement percent score would be the most 
straight-forward and simple way to incorporate improvement. For the 
purpose of improvement scoring methodology, the term ``quality 
performance category achievement percent score'' means the total 
measure achievement points divided by the total possible available 
measure achievement points, without consideration of bonus points or 
improvement adjustments and is discussed in the proposed rule (82 FR 
30116 through 30117).
    Consistent with bonuses available in the quality performance 
category, we proposed at Sec.  414.1380(b)(1)(xvi)(B) that the 
improvement percent score may not total more than 10 percentage points.
    We invited public comments on these proposals.
    The following is a summary of the public comments received on the 
proposal for scoring improvement at the quality performance category 
level and our responses:
    Comment: Many commenters supported improvement scoring at the 
category level for the quality performance category score and adding 
the improvement percent score to the quality performance category 
percent score. Many commenters noted it provides a bonus incentive, 
rather than a penalty for MIPS eligible clinicians. Many commenters 
supported flexibility in measure choice because clinicians could choose 
the most clinically relevant measures; the approach is less complicated 
than others; clinicians are adjusting to the MIPS program; and would 
encourage clinicians to adopt more difficult measures. A few commenters 
believed the approach would incentivize clinician progress toward 
achieving quality outcomes and care efficiency because it would 
encourage clinicians to move away from reporting topped out measures 
and begin reporting new, more meaningful quality measures. One 
commenter noted it was administratively burdensome to report new 
measures; therefore, clinicians would only change measures if they are 
relevant and the category scoring allows them the flexibility to change 
their measures. One commenter supported the approach because it 
recognizes and encourages higher standards of quality among all 
clinicians and increases opportunities for providers to succeed despite 
challenges associated with serving patients with high social risk 
factors. One commenter believed that the proposal would encourage 
smaller practices to participate in the MIPS program.
    Response: We thank the commenters for their support, and we are 
finalizing these policies as proposed.
    Comment: A few commenters supported category level improvement 
scoring, but suggested that CMS should monitor for the frequency of 
clinicians switching measures, which could potentially warrant 
consideration of alternative approaches, and whether category level 
improvement scoring was needed in the future.
    Response: We intend to monitor the MIPS scoring methodology, 
including frequency of clinicians switching measures and the need for 
category level improvement scoring, as the program transitions. We will 
address any changes of improvement scoring through future rulemaking.
    Comment: A few commenters supported the proposed capping of 
improvement points at no more than 10 percentage points as proposed at 
Sec.  414.1380(b)(1)(xvi)(B). One commenter supported the proposed 10 
percentage points available in the quality performance category because 
it would encourage clinician participation and offset negative payment 
adjustments for clinicians acclimating to pay for performance programs.
    Response: We thank the commenters for their support.
    Comment: One commenter requested an increase in the number of bonus 
points available for improvement scoring.
    Response: We believe that capping the improvement percent score at 
10 percentage points is consistent with the bonuses available in the 
quality performance category and appropriate for rewarding year-to-year 
improvement in the quality performance category.
    Comment: One commenter did not support the proposed bonus of 10 
percentage points because it is excessive and would penalize 
consistently high-performing practices.
    Response: We disagree with the characterization of the proposed 
bonus points for improvement as excessive. Ten percentage points is 
consistent with other bonuses in the quality performance category and 
therefore simpler to describe and understand. Additionally, we believe 
it is a sufficient incentive for both high and low performers, 
appropriately provides a larger incentive for low performers to 
improve, and will have the greatest impact on improving quality for 
beneficiaries.
    Comment: Many commenters did not support measuring quality 
improvement at the performance category level because it could lead to 
inadvertently rewarding eligible clinicians who have not improved, but 
rather selected different measures, and instead recommended the 
adoption of a measure level approach, which is more precise. Commenters 
noted that this would align with the cost performance category. A few 
commenters recommended that, should CMS implement a measure level 
approach, improvement could only be assessed on any measure that meets 
the data completeness threshold and is reported year over year. One 
commenter suggested that CMS restrict improvement to MIPS eligible 
clinicians and groups that report on at least half of the measures 
reported in the prior MIPS performance period during the current MIPS 
performance period. One commenter suggested restricting improvement to 
the first few years that a measure is used because this would 
incentivize lower performers to invest time and resources to improve.
    Response: We appreciate the commenters' concerns with measuring 
improvement at the performance category level and support for an

[[Page 53739]]

alternative approach to measure improvement at the measure level for 
the quality performance category. We believe that, particularly in the 
early years of MIPS implementation, providing clinicians the 
flexibility to choose the measures for the quality performance 
category, rather than a more restrictive approach that would limit the 
choice of measures, will enable them to select measures that are most 
appropriate for their practice from 1 year to the next, will encourage 
participation in the MIPS program, and will incentivize clinicians to 
invest in improving their quality of care delivery. We believe that 
restricting improvement scoring to measures which meet data 
completeness and MIPS eligible clinicians who reported one or more 
measures over multiple years would unduly limit the availability of 
this incentive, particularly for those who are transitioning away from 
topped out measures. As described in section II.C.6.d. of this final 
rule with comment period, the cost performance category does not allow 
for the selection of measures, so we believe it is appropriate for the 
quality performance to have a different methodology.
    We do not believe our improvement scoring methodology will drive 
clinicians to select different measures in order to earn a higher 
improvement score, nor do we anticipate that clinicians will make 
investments to change and excel at quality measures solely to earn a 
higher improvement score. As noted in section II.C.7.a.(1)(b)(i) of 
this final rule with comment period, we intend to evaluate the 
implementation of improvement scoring for the quality and cost 
performance categories to determine how the policies we establish in 
this final rule with comment period are affecting MIPS eligible 
clinicians.
    Comment: Many commenters recommended a delay in implementing 
improvement scoring because they believed that CMS should focus on 
quality reporting and assessment; seek feedback and experience; and 
develop more robust, valid, and accurate sets of measures. They were 
also concerned with the consistency of quality measure benchmarks.
    Response: We appreciate the commenters' concerns related to the 
validity and accuracy of current measure sets and the consistency of 
quality measure benchmark. We also recognize commenters' recommendation 
of a delay in the implementation of improvement scoring to allow for a 
focus on quality reporting and assessment. Section 1848(q)(5)(D)(i) of 
the Act requires improvement to be taken into account for the quality 
performance category and the cost performance category if data 
sufficient to measure improvement is available. We do not believe the 
concerns noted by the commenters make the data insufficient or 
unavailable. Please see section II.C.7.a.(2)(i)(ii) of this final rule 
with comment period for a discussion of why we believe that data is 
sufficient to measure improvement in the quality performance category 
and a delay is not warranted.
    Comment: Several commenters believed the proposed approach adds 
complexity because it would be difficult to communicate to clinicians, 
is not straightforward and transparent, and clinicians would not 
understand how they are being rewarded for improvement. A few 
commenters believed that the proposed approach is too new and too 
complex to ensure that quality improvement is being measured validly 
and reliably.
    Response: While improvement is an additional factor to be 
considered in the MIPS quality performance category score calculation, 
we are required to take improvement into account for the quality 
performance category and the cost performance category if data 
sufficient to measure improvement is available. Given the flexibility 
in quality measurement, we wanted to have improvement scoring be 
broadly available to MIPS eligible clinicians. We intend to develop 
additional educational materials to explain the improvement scoring. We 
believe that encouraging continued improvement in clinician quality 
performance will raise the quality of care delivered and benefit the 
health outcomes of beneficiaries.
    Comment: Several commenters expressed concerns about the impact of 
topped out measures because they potentially confound the accurate 
measurement of improvement. These commenters believed that clinicians 
should not be penalized for changes in quality reporting that are out 
of their control such as elimination of measures or the learning curve 
for reporting new measures; believed that specialists could have 
difficulty demonstrating improvement; and recommended that improvement 
focus on outcome measures.
    Response: We understand the commenters' concerns about the impact 
of topped out measures and measure availability and appreciate the 
recommendation to focus on outcome measures. We do not believe that 
topped out measures and the identification and removal of topped out 
measures will significantly impact the accurate measurement of 
improvement because there will be sufficient measure choice and 
flexibility for clinicians to choose measures that represent areas for 
performance category level improvement. In addition, we believe that 
measuring improvement at the performance category level will encourage 
movement away from topped out measures toward new high priority 
measures that may have additional measure bonus points. We also believe 
that improvement should be made broadly available to clinicians to 
encourage MIPS participation, and therefore, do not support restricting 
improvement scoring to clinicians that submit a specific number of 
outcomes measures or only outcome measures.
    Comment: Several commenters suggested the adoption of alternative 
approaches to implementing improvement at the performance category 
level, such as the Hospital VBP Program, because with the proposed 
category level scoring MIPS eligible clinicians could achieve a higher 
performance by changing the measures they choose, whereas with the 
alternate approaches, the stability in the measures reported could 
foster greater improvement in those areas, and this approach would 
provide a clearer picture of the change in the quality of care over 
time. A few commenters suggested that CMS develop an alternative 
approach that does not put already-high-performing physicians or groups 
at a disadvantage compared to lower-performing practices and that 
builds on the existing benchmark structure. One commenter recommended 
that CMS test each of the proposed methodologies in clinician practices 
before introducing them in MIPS. One commenter recommended that CMS 
seek a method that is straightforward and transparent.
    Response: As we described in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30096 through 30098), we do not believe the 
Hospital VBP Program approach would be appropriate for MIPS because it 
does not reward points for achievement in the same manner and would 
require significant changes to the scoring methodology for the quality 
performance category. We continue to believe that flexibility for 
clinicians to select meaningful measures is appropriate for MIPS, 
especially for the quality performance category. The Hospital VBP 
Program methodology, which relies on consistent measures from year to 
year in order to track improvement, would limit our ability to measure 
improvement in MIPS. As noted above, we do not anticipate that 
clinicians would change measures

[[Page 53740]]

solely for the purposes of improvement scoring. We do not expect that 
there will be a disadvantage for high performing clinicians as they 
already would already have a high performance score and are potentially 
eligible for improvement. We believe that improvement scoring will 
provide relatively larger incentives for lower performers who raise 
their performance level at a greater rate, but we anticipate this will 
benefit quality for beneficiaries. We believe the proposed approach is 
transparent and provides clarity on a clinician performance from 1 year 
to the next.
    Comment: A few commenters requested clarity regarding how the 
improvement score would be calculated for clinicians who are changing 
CEHRT systems or adopting a CEHRT system.
    Response: Improvement scoring would not be directly impacted by 
clinicians changing or adopting a CEHRT system because it would be 
calculated at the performance category level.
    Comment: One commenter believed that scoring for improvement was 
unnecessary because a clinician's improvement is reflected in their 
final score, which can be compared to the previous year's final score 
with a higher score, potentially resulting in the clinician receiving a 
higher payment adjustment.
    Response: We are accounting for improvement for the quality 
performance category as required under section 1848(q)(5)(D) of the 
Act. The commenter is correct that clinicians who qualify for 
improvement scoring would have a higher quality performance category 
achievement percent score; however, we believe it is appropriate to 
provide an improvement adjustment on top of that score to create 
incentives for continuous improvement.
    Comment: One commenter believed that the nature of different 
organizations' practices, including region, payer mix, specialty, and 
mode of practice, may well require adjusted treatment of reported 
scores to ensure that a valid measure of improvement is being 
calculated.
    Response: The performance category level approach is based on 
improvement in a MIPS eligible clinician's performance from the current 
MIPS performance period compared to a comparable score from the 
previous MIPS performance period. Because we are making the comparison 
to the MIPS eligible clinician and not to other organizations or 
practices, we do not see the need to adjust improvement scores in 
consideration of these factors.
    Comment: One commenter believed the proposed approach would be 
difficult to communicate to clinicians and would obscure a clinician's 
overall progress. One commenter believed that the lag time between 
performance and feedback does not allow adequate time to implement 
actionable changes the drive improvement.
    Response: We believe that improvement scoring, while adding a layer 
of complexity to MIPS scoring overall, is an easy to understand 
approach that will provide important insight into clinician performance 
from 1 year to the next. As discussed in section II.C.9.a.(1) of this 
final rule with comment period, we continue to work on ways to improve 
performance feedback.
    Comment: One commenter recommended that improvement should be 
defined more broadly to encourage participants to report new aspects of 
the MIPS program, participate in pilots, use registries, or other tools 
that CMS seeks to promote. One commenter recommended a phased-in 
approach, such as with a pilot test with a limited number of 
clinicians.
    Response: We do not believe that that reporting or participation by 
itself meets a requirement for improvement for purposes of the quality 
performance category. In addition, our MIPS quality performance 
category scoring policies already include bonuses to promote the use of 
high priority measures and end-to-end electronic reporting. We believe 
that a phased-in approach or pilot study would limit the availability 
of improvement scoring, especially to clinicians who may best benefit 
from improvement scoring.
    Final Action: As a result of the public comments, we are finalizing 
as proposed at Sec.  414.1380(b)(1)(xvi)(E) to define an improvement 
percent score to mean the score that represents improvement for the 
purposes of calculating the quality performance category score. We are 
also finalizing as proposed at proposed at Sec.  414.1380(b)(1)(xvi)(C) 
that an improvement percent score would be assessed at the quality 
performance category level and included in the calculation of the 
quality performance category percent score. We are also finalizing as 
proposed at Sec.  414.1380(b)(1)(xvi)(B) that the improvement percent 
score may not total more than 10 percentage points.
(ii) Data Sufficiency Standard to Measure Improvement for Quality 
Performance Category
    Section 1848(q)(5)(D)(i) of the Act stipulates that beginning with 
the second year to which the MIPS applies, if data sufficient to 
measure improvement is available, then we shall measure improvement for 
the quality performance category. Measuring improvement requires a 
direct comparison of data from one Quality Payment Program year to 
another. Starting with the 2020 MIPS payment year, we proposed that a 
MIPS eligible clinician's data would be sufficient to score improvement 
in the quality performance category if the MIPS eligible clinician had 
a comparable quality performance category achievement percent score for 
the MIPS performance period immediately prior to the current MIPS 
performance period (82 FR 30114); we explain our proposal to identify 
how we will identify ``comparable'' quality performance category 
achievement percent scores below. We noted that we believe that this 
approach would allow improvement to be broadly available to MIPS 
eligible clinicians and encourage continued participation in the MIPS 
program. Moreover, this approach would encourage MIPS eligible 
clinicians to focus on efforts to improve the quality of care 
delivered. We noted that, by measuring improvement based only on the 
overall quality performance category achievement percent score, some 
MIPS eligible clinicians and groups may generate an improvement score 
simply by switching to measures on which they perform more highly, 
rather than actually improving at the same measures. We will monitor 
how frequently improvement is due to actual improvement versus 
potentially perceived improvement by switching measures and will 
address through future rulemaking, as needed. We also solicited comment 
on whether we should require some level of year to year consistency 
when scoring improvement.
    We proposed that ``comparability'' of quality performance category 
achievement percent scores would be established by looking first at the 
submitter of the data. As discussed in more detail in the proposed rule 
(82 FR 300113 through 300114), we are comparing results at the 
category, rather than the performance measure level because we believe 
that the performance category score from 1 year is comparable to the 
performance category score from the prior performance period, even if 
the measures in the performance category have changed from year to 
year.
    We proposed to compare results from an identifier when we receive 
submissions with that same identifier (either TIN/NPI for individual, 
or TIN for group, APM entity, or virtual group identifier) for two 
consecutive performance periods. However, if we do

[[Page 53741]]

not have the same identifier for 2 consecutive performance periods, we 
proposed a methodology to create a comparable performance category 
score that can be used for improvement measurement. Just as we did not 
want to remove the opportunity to earn an improvement score from those 
who elect new measures between performance periods for the quality 
performance category, we also did not want to restrict improvement for 
those MIPS eligible clinicians who elect to participate in MIPS using a 
different identifier.
    There are times when submissions from a particular individual 
clinician or group of clinicians use different identifiers between 2 
years. For example, a group of 20 MIPS eligible clinicians could choose 
to submit as a group (using their TIN identifier) for the current 
performance period. If the group also submitted as a group for the 
previous year's performance period, we would simply compare the group 
scores associated with the previous performance period to the current 
performance period (following the methodology explained in the proposed 
rule (82 FR 30116 through 30117)). However, if the group members had 
previously elected to submit to MIPS as individual clinicians, we would 
not have a group score at the TIN level from the previous performance 
period to which to compare the current performance period.
    In circumstances where we do not have the same identifier for 2 
consecutive performance periods, we proposed to identify a comparable 
score for individual submissions or calculate a comparable score for 
group, virtual group, and APM entity submissions. For individual 
submissions, if we do not have a quality performance category 
achievement percent score for the same individual identifier in the 
immediately prior period, then we proposed to apply the hierarchy logic 
that is described in section II.C.8.a.(2) of the proposed rule (82 FR 
30146 through 30147) to identify the quality performance category 
achievement score associated with the final score that would be applied 
to the TIN/NPI for payment purposes. For example, if there is no 
historical score for the TIN/NPI, but there is a TIN score (because in 
the previous period the TIN submitted as a group), then we would use 
the quality performance category achievement percent score associated 
with the TIN's prior performance. If the NPI had changed TINs and there 
was no historical score for the same TIN/NPI, then we would take the 
highest prior score associated with the NPI.
    When we do not have a comparable TIN group, virtual group, or APM 
Entity score, we proposed to calculate a score based on the individual 
TIN/NPIs in the practice for the current performance period. For 
example, in a group of 20 clinicians that previously participated in 
MIPS as individuals, but now want to participate as a group, we would 
not have a comparable TIN score to use for scoring improvement. We 
believe however it is still important to provide to the MIPS eligible 
clinicians the improvement points they have earned. Similarly, in cases 
where a group of clinicians previously participated in MIPS as 
individuals, but now participates as a new TIN, or a new virtual group, 
or a new APM Entity submitting data in the performance period, we would 
not have a comparable TIN, virtual group, or APM Entity score to use 
for scoring improvement. Therefore, we proposed to calculate a score by 
taking the average of the individual quality performance category 
achievement scores for the MIPS eligible clinicians that were in the 
group for the current performance period. If we have more than one 
quality performance category achievement percent score for the same 
individual identifier in the immediately prior period, then we proposed 
to apply the hierarchy logic that is described in section II.C.8.a.(2) 
of the proposed rule (82 FR 30146 through 30147) to identify the 
quality performance category score associated with the final score that 
would be applied to the TIN/NPI for payment purposes. We would exclude 
any TIN/NPIs that did not have a final score because they were not 
eligible for MIPS. We would include quality performance category 
achievement percent scores of zero in the average.
    There are instances where we would not be able to measure 
improvement due to lack of sufficient data. For example, if the MIPS 
eligible clinicians did not participate in MIPS in the previous 
performance period because they were not eligible for MIPS, we could 
not calculate improvement because we would not have a previous quality 
performance category achievement percent score.
    Table 26 in the proposed rule (82 FR 30115) summarized the 
different cases when a group or individual would be eligible for 
improvement scoring under the proposal which we have replicated for 
convenience in Table 23.

                         Table 23--Proposed Eligibility for Improvement Scoring Examples
----------------------------------------------------------------------------------------------------------------
                                                       Prior MIPS
                                                      performance
                                   Current MIPS    period Identifier     Eligible for
           Scenario                performance        (with score         improvement       Data comparability
                                period identifier     greater than          scoring
                                                         zero)
----------------------------------------------------------------------------------------------------------------
No change in identifier.......  Individual (TIN..  Individual (TIN..  Yes...............  Current individual
                                A/NPI 1).........  A/NPI 1).........                       score is compared to
                                                                                           individual score from
                                                                                           prior performance
                                                                                           period.
No change in identifier.......  Group (TIN A)....  Group (TIN A)....  Yes...............  Current group score is
                                                                                           compared to group
                                                                                           score from prior
                                                                                           performance period.
Individual is with same group,  Individual (TIN..  Group (TIN A)....  Yes...............  Current individual
 but selects to submit as an    A/NPI 1).........                                          score is compared to
 individual whereas previously                                                             the group score
 the group submitted as a                                                                  associated with the
 group.                                                                                    TIN/NPI from the
                                                                                           prior performance
                                                                                           period.
Individual changes practices,   Individual (TIN..  Individual (TIN..  Yes...............  Current individual
 but submitted to MIPS          B/NPI)...........  A/NPI)...........                       score is compared to
 previously as an individual.                                                              the individual score
                                                                                           from the prior
                                                                                           performance period.
Individual changes practices    Individual (TIN..  Group (TIN A/      Yes...............  Current individual
 and has multiple scores in     C/NPI)...........   NPI); Individual                       score is compared to
 prior performance period.                          (TIN B/NPI).                           highest score from
                                                                                           the prior performance
                                                                                           period.

[[Page 53742]]

 
Group does not have a previous  Group (TIN A)....  Individual scores  Yes...............  The current group
 group score from prior                             (TIN A/NPI 1,                          score is compared to
 performance period.                                TIN A/NPI 2, TIN.                      the average of the
                                                   A/NPI 3, etc.)...                       scores from the prior
                                                                                           performance period of
                                                                                           individuals who
                                                                                           comprise the current
                                                                                           group.
Virtual group does not have     Virtual Group      Individuals (TINA/ Yes...............  The current group
 previous group score from       (Virtual Group     NPI 1, TIN A/NPI                       score is compared to
 prior performance period.       Identifier A)      2, TIN B/NPI 1,                        the average of the
                                 (Assume virtual    TIN B/NPI 2).                          scores from the prior
                                 group has 2 TINs                                          performance period of
                                 with 2                                                    individuals who
                                 clinicians.).                                             comprise the current
                                                                                           group.
Individual has score from       Individual (TIN..  APM Entity (APM    Yes...............  Current individual
 prior performance period as    A/NPI 1).........   Entity                                 score is compared to
 part of an APM Entity.                             Identifier).                           the score of the APM
                                                                                           entity from the prior
                                                                                           performance period.
Individual does not have a      Individual (TIN..  Individual was     No................  The individual quality
 quality performance category   A/NPI 1).........   not eligible for                       performance category
 achievement score for the                          MIPS and did not                       score is missing for
 prior performance period.                          voluntarily                            the prior performance
                                                    submit any                             period and not
                                                    quality measures                       eligible for
                                                    to MIPS.                               improvement scoring.
----------------------------------------------------------------------------------------------------------------

    We proposed at Sec.  414.1380(b)(1)(xvi)(A) to state that 
improvement scoring is available when the data sufficiency standard is 
met, which means when data are available and a MIPS eligible clinician 
or group has a quality performance category achievement percent score 
for the previous performance period. We also proposed at Sec.  
414.1380(b)(1)(xvi)(A)(1) that data must be comparable to meet the 
requirement of data sufficiency, which means that the quality 
performance category achievement percent score is available for the 
current performance period and the previous performance period and, 
therefore, quality performance category achievement percent scores can 
be compared. We also proposed at Sec.  414.1380(b)(1)(xvi)(A)(2) that 
quality performance category achievement percent scores are comparable 
when submissions are received from the same identifier for two 
consecutive performance periods. We also proposed an exception at Sec.  
414.1380(b)(1)(xvi)(A)(3) that if the identifier is not the same for 2 
consecutive performance periods, then for individual submissions, the 
comparable quality performance category achievement percent score is 
the quality performance category achievement percent score associated 
with the final score from the prior performance period that will be 
used for payment. For group, virtual group, and APM entity submissions, 
the comparable quality performance category achievement percent score 
is the average of the quality performance category achievement percent 
score associated with the final score from the prior performance period 
that will be used for payment for each of the individuals in the group. 
As noted above, the proposals were designed to offer improvement 
scoring to all MIPS eligible clinicians with sufficient data in the 
prior MIPS performance period. We invited public comments on our 
proposals as they relate to data sufficiency for improvement scoring.
    We also sought comment on an alternative to the proposal: whether 
we should restrict improvement to those who submit quality performance 
data using the same identifier for two consecutive MIPS performance 
periods. We believed this option would be simpler to apply, communicate 
and understand than our proposal is, but this alternative could have 
the unintended consequence of not allowing improvement scoring for 
certain MIPS eligible clinicians, groups, virtual groups and APM 
entities.
    The following is a summary of the public comments received on our 
proposals related to data sufficiency for improvement scoring and our 
responses:
    Comment: Many commenters believed there was not sufficient data to 
score improvement because MIPS data has not yet been collected, the 
data in pick-your-pace approach for the 2017 MIPS performance period 
may not be representative, and some practices may not understand that 
they must fully participate in the quality category in order to receive 
an improvement score.
    Response: We disagree that there is not enough data collected to 
meet the data sufficiency standard. As required by section 
1848(q)(5)(D) of the Act, improvement must be incorporated into the 
MIPS scoring methodology for the 2018 MIPS performance period if data 
sufficient to measure improvement is available. By the end of the 2018 
MIPS performance period, we will have collected data for the 2017 MIPS 
performance period. While this data may have limitations due to the 
``pick your pace'' transition, clinicians will have a quality 
performance category achievement percent score which is sufficient to 
measure quality. As discussed in section II.C.7.a.(2)(i)(ii) of this 
final rule with comment period, we should not be similarly limited in 
the availability of sufficient data for year 2.
    Comment: Several commenters supported the proposal for a comparable 
identifier because this approach would not penalize clinicians changing 
jobs, changes in group composition, or new elections to report as a 
group. One commenter believed this approach would support the 
establishment of virtual groups. One commenter believed limitations to 
the same identifier would restrict those eligible for improvement.
    Response: We thank the commenters for their support. We agree that 
this approach provides flexibility for clinicians to allow for changes 
in their practice that could include establishing and reporting as part 
of a virtual group.
    Comment: A few commenters recommended restricting improvement to 
those who submit quality performance data using the same identifier for 
two consecutive MIPS performance periods as it is a simpler

[[Page 53743]]

approach and easier to understand. One commenter supported restricting 
improvement to those MIPS eligible clinicians who use the same 
identifier and same mechanism of reporting for two consecutive 
performance periods. One commenter requested clarification on the 
impact on group practices when the entity was participating in an APM 
entity in the prior performance period. One commenter believed that 
tracking different identifiers would require physicians to factor in 
additional considerations when they are just trying to learn the 
program, such as the requirement that MIPS eligible clinicians must 
fully participate in the quality performance category in order to 
receive an improvement score. One commenter expressed concerns that the 
requirement for data from two consecutive performance periods for 
specific clinicians may reward stable and high performing practices and 
clinicians while struggling practices with high turnover rates may fall 
further behind. One commenter believed that tracking clinician scores 
from previous years would increase the overhead costs for Qualified 
Registries and QCDRs.
    Response: Within MIPS, we must balance complexity with flexibility. 
We believe improvement scoring should be available to the broadest 
number of eligible clinicians to incentivize increases in the quality 
performance category scores and have the greatest impact on increasing 
quality of care. Thus, we have provided for the use of a comparable 
identifier when we do not have the same identifier from 1 year to 
another. Table 23 summarizes different cases when a group or individual 
would be eligible for improvement scoring under our proposal including 
when we do not have identical identifiers. For a MIPS eligible 
clinician reporting as an individual in the current performance period 
who reported as part of an APM entity in the previous performance 
period, we would use the score of the APM entity as a point of 
comparison with the MIPS eligible clinician's score in the current 
performance period to determine eligibility for improvement. 
Improvement scoring can only increase a quality performance category 
score, not decrease it. The burden to track and calculate this score 
will not impact external stakeholders and should not impact clinician 
decisions on how to submit data, as our systems will help do the 
tracking of clinician scores from previous years.
    Final Action: As a result of the public comments, we are finalizing 
as proposed at Sec.  414.1380(b)(1)(xvi)(A) that improvement scoring is 
available when the data sufficiency standard is met which means when 
data are available and a MIPS eligible clinician has a quality 
performance category achievement percent score for the previous 
performance period and the current performance period. We are also 
finalizing as proposed at Sec.  414.1380(b)(1)(xvi)(A)(1) that data 
must be comparable to meet the requirement of data sufficiency, which 
means a quality performance category achievement percent score is 
available for the current and previous performance periods and quality 
performance category achievement percent scores can be compared. We are 
also finalizing as proposed at Sec.  414.1380(b)(1)(xvi)(A)(2) that the 
quality performance category achievement percent scores are comparable 
when submissions are received from the same identifier for two 
consecutive performance periods. We are also finalizing as proposed at 
Sec.  414.1380(b)(1)(xvi)(A)(3) that if the identifier is not the same 
for 2 consecutive performance periods, then for individual submissions, 
the comparable quality performance category achievement percent score 
is the highest available quality performance category achievement 
percent score associated with the final score from the prior 
performance period that will be used for payment for the individual. 
For group, virtual group, and APM Entity submissions, the comparable 
quality performance category achievement percent score is the average 
of the quality performance category achievement percent score 
associated with the final score from the prior performance period that 
will be used for payment for each of the individuals in the group.
(iii) Additional Requirement for Full Participation To Measure 
Improvement for Quality Performance Category
    To receive a quality performance category improvement percent score 
greater than zero, we also proposed that MIPS eligible clinicians must 
fully participate, which we proposed in Sec.  414.1380(b)(1)(xvi)(F) to 
mean compliance with Sec.  414.1330 and Sec.  414.1340, in the current 
performance year (81 FR 30116). Compliance with those referenced 
regulations entails the submission of all required measures, including 
meeting data completeness, for the quality performance category for the 
current performance period. For example, for MIPS eligible clinicians 
submitting via QCDR, full participation would generally mean submitting 
6 measures including 1 outcome measure if an outcome measure is 
available or 1 high priority measure if an outcome measure is not 
available, and meeting the 60 percent data completeness criteria for 
each of the 6 measures.
    We believe that improvement is most meaningful and valid when we 
have a full set of quality measures. A comparison of data resulting 
from full participation of a MIPS eligible clinician from 1 year to 
another enables a more accurate assessment of improvement because the 
performance being compared is based on the applicable and available 
measures for the performance periods and not from changes in 
participation. While we did not require full participation for both 
performance periods, requiring full participation for the current 
performance period means that any future improvement scores for a 
clinician or group would be derived solely from changes in performance 
and not because the clinician or group submitted more measures. We 
proposed at Sec.  414.1380(b)(1)(xvi)(C)(5) that the quality 
improvement percent score is zero if the clinician did not fully 
participate in the quality performance category for the current 
performance period.
    Because we want to award improvement for net increases in 
performance and not just improved participation in MIPS, we want to 
measure improvement above a floor for the 2018 MIPS performance period, 
to account for our transition year policies. We considered that MIPS 
eligible clinicians who chose the ``test'' option of the ``pick your 
pace'' approach for the transition year may not have submitted all the 
required measures and, as a result, may have a relatively low quality 
performance category achievement score for the 2017 MIPS performance 
period. Due to the transition year policy to award at least 3 measure 
achievement points for any submitted measure via claims, EHR, QCDR, 
qualified registry, and CMS-approved survey vendor for CAHPS for MIPS, 
and the 3-point floor for the all-cause readmission measure (if the 
measure applies), a MIPS eligible clinician that submitted some data 
via these mechanisms on the required number of measures would 
automatically have a quality performance category achievement score of 
at least 30 percent because they would receive at least 3 of 10 
possible measure achievement points for each required measure. For 
example, if a solo practitioner submitted 6 measures and received 3 
points for each measure, then the solo practitioner would have 18 
measure achievement points out of a possible 60 total possible measure 
achievement points (3 measure achievement points x 6 measures). The

[[Page 53744]]

quality performance category achievement percent score is 18/60 which 
equals 30 percent. For groups with 16 or more clinicians that submitted 
6 measures and receive 3 measure achievement points for each submitted 
measure as well as the all-cause hospital readmission measure, then the 
group would have 21 measure achievement points out of 70 total possible 
measure achievement points or a quality performance category 
achievement percent score of 21/70 which equals 30 percent (3 measure 
achievement points x 7 measures). For the CMS Web Interface submission 
option, MIPS eligible clinicians that fully participate by submitting 
and meeting data completeness for all measures, would also be able to 
achieve a quality performance category achievement percent score of at 
least 30 percent, as each scored measure would receive 3 measure 
achievement points out of 10 possible measure achievement points.
    Therefore, we proposed at Sec.  414.1380(b)(1)(xvi)(C)(4) that if a 
MIPS eligible clinician has a previous year quality performance 
category score less than or equal to 30 percent, we would compare 2018 
performance to an assumed 2017 quality performance category achievement 
percent score of 30 percent. In effect, for the MIPS 2018 performance 
period, improvement would be measured only if the clinician's 2018 
quality performance category achievement percent score for the quality 
performance category exceeds 30 percent. We believe this approach 
appropriately recognizes the participation of MIPS eligible clinicians 
who participated in the transition year and accounts for MIPS eligible 
clinicians who participated minimally and may otherwise be awarded for 
an increase in participation rather than an increase in achievement 
performance.
    We invited public comment on these proposals.
    The following is a summary of the public comments received on our 
proposal for full participation related to improvement scoring and our 
responses:
    Comment: Several commenters supported the requirement for full 
participation in the performance period.
    Response: We appreciate your support of our proposal.
    Comment: One commenter requested the expansion of the eligibility 
criteria to include those clinicians that were unable to report 
complete data in the previous year because moving from incomplete data 
to complete data in 1 year is a significant achievement and should be 
recognized by CMS. One commenter believed the requirement of full 
participation will add complexity when clinicians are trying to learn 
the program and may not understand that they must fully participate in 
the quality performance category in order to receive an improvement 
score. One commenter recommended a separate improvement calculation or 
bonus for clinicians who do not meet full participation for the early 
years of MIPS performance because incentivizing incremental increases 
in performance in the early years will be an important way to encourage 
clinicians and groups to participate in MIPS without adding too much 
administrative burden in a single year.
    Response: We understand that adding in the full participation 
requirement adds a layer of complexity; however, MIPS is required to 
measure performance, not participation. We note that full participation 
would generally mean submitting 6 measures, including 1 outcome measure 
if available, or 1 high priority measure if an outcome measure is not 
available, and meeting the data completeness criteria for each of the 6 
measures; for eligible clinicians who do not have 6 measures available 
or applicable, full participation is met by submitting the measures 
that are available and applicable and the data completeness requirement 
for those submitted measures. We do not believe increased participation 
is sufficient enough to warrant receiving an improvement score, and we 
believe that we need the full participation requirement to ensure that 
we are capturing data that can be used to measure performance.
    Comment: One commenter suggested that the regulatory language be 
changed to: Sec.  414.1380(b)(1)(xvi)(A) Improvement scoring is 
available when the data sufficiency standard is met, which means when 
data are available and a MIPS eligible clinician fully participated in 
the previous performance period. This references the definition of 
``fully participate'' given in Sec.  414.1380(b)(1)(xvi)(F): For the 
purpose of improvement scoring methodology, the term ``fully 
participate'' means the MIPS eligible clinician met all requirements in 
Sec. Sec.  414.1330 and 414.1340.
    Response: We disagree that the clinicians should need to have fully 
participated in the prior period in order to have sufficient data to 
measure improvement. We believe our proposal to require full 
participation in the current performance period and not necessarily the 
prior performance period creates an additional incentive to fully 
participate in the current performance period in order to be eligible 
for improvement scoring and have data available for future performance 
measurement. In addition, our proposal to measure improvement above 30 
percent helps to ensure that we are measuring true changes in 
performance and not just changes in the level of participation.
    Comment: A few commenters supported the implementation of 
additional requirements for improvement scoring, including the 
requirement of participation during the transition year at a level to 
achieve a quality category achievement percent score of at least 30 
percent. A few commenters suggested that improvement bonuses only be 
available to those who fully participate in both the current and the 
previous year to close this loophole. One commenter suggested that 30 
percent should be the minimum improvement score percentage floor 
because it would encourage continued participation by clinicians, 
including specialists.
    Response: As noted earlier, we disagree that the clinicians should 
need to have fully participated in the prior period in order to be 
measured for improvement. We think our proposal to require full 
participation in the current performance period and not necessarily the 
prior performance period creates an additional incentive to fully 
participate in the current performance period in order to be eligible 
for improvement scoring and have data available for future performance 
measurement. We also believe improvement scoring should be available to 
the broadest number of eligible clinicians to incentivize increases in 
the quality performance category scores and have the greatest impact on 
increasing quality of care. In addition, our proposal to measure 
improvement above 30 percent helps to ensure that we are measuring true 
changes in performance and not just changes in participation.
    Final Action: As a result of the public comments, we are finalizing 
as proposed that MIPS eligible clinicians must fully participate, which 
we propose in Sec.  414.1380(b)(1)(xvi)(F) to mean compliance with 
Sec.  414.1330 and Sec.  414.1340, in the current performance year. We 
are also finalizing as proposed at Sec.  414.1380(b)(1)(xvi)(C)(5) that 
the quality improvement percent score is zero if the clinician did not 
fully participate in the quality performance category for the current 
performance period. We are also finalizing as proposed at Sec.  
414.1380(b)(1)(xvi)(C)(4) that if a MIPS eligible clinician has a 
previous year quality performance category score less than or equal to 
30 percent, we would compare 2018

[[Page 53745]]

performance to an assumed 2017 quality performance category achievement 
percent score of 30 percent.
(iv) Measuring Improvement Based on Changes in Achievement
    To calculate improvement with a focus on quality performance, we 
proposed to focus on improvement based on achievement performance and 
would not consider measure bonus points in our improvement algorithm 
(82 FR 30116 through 30117). Bonus points may be awarded for reasons 
not directly related to performance such as the use of end-to-end 
electronic reporting. We believe that improvement points should be 
awarded based on improvement related to achievement. Accordingly, we 
are proposing to use an individual MIPS eligible clinician's or group's 
total measure achievement points from the prior MIPS performance period 
without the bonus points the individual MIPS eligible clinician or 
group may have received, to calculate improvement. Therefore, to 
measure improvement at the quality performance category level, we will 
use the quality performance category achievement percent score 
excluding measure bonus points (and any improvement score) for the 
applicable years. We proposed at Sec.  414.1380(b)(1)(xvi)(D) to call 
this score, which is based on achievement only, the ``quality 
performance category achievement percent score'' which is calculated 
using the following formula:

Quality performance category achievement percent score = total measure 
achievement points/total available measure achievement points.

    The current MIPS performance period quality performance category 
achievement percent score is compared to the previous performance 
period quality performance category achievement percent score. If the 
current score is higher, the MIPS eligible clinician may qualify for an 
improvement percent score to be added into the quality performance 
category percent score for the current performance year. Table 27 of 
the proposed rule (82 FR 30117) illustrated how the quality performance 
category achievement percent score is calculated.
    We proposed to amend the regulatory text at Sec.  
414.1380(b)(1)(xvi) to state that improvement scoring is available to 
MIPS eligible clinicians and groups that demonstrate improvement in 
performance in the current MIPS performance period compared to the 
performance in the previous MIPS performance period, based on 
achievement. Bonus points or improvement percent score adjustments made 
to the category score in the prior or current performance period are 
not taken into account when determining whether an improvement has 
occurred or the size of any improvement percent score.
    We invited public comment on our proposal to award improvement 
based on changes in the quality performance category achievement 
percent score.
    The following is a summary of the public comments received on our 
proposal to measure improvement based on changes in achievement in the 
quality performance category and our responses:
    Comment: A few commenters agreed with not including bonus points in 
the calculation.
    Response: We appreciate the support of our proposal.
    Comment: One commenter recommended including the bonus for end-to-
end electronic reporting in the calculation for the improvement percent 
score. One commenter suggested counting bonus points for scenarios 
where additional outcome or high priority measures are reported because 
the bonus point does have a stronger tie to performance and will help 
provide incentives for eligible clinicians to move toward reporting of 
more outcome measures in the future.
    Response: We appreciate your suggestions to incorporate bonus 
points into improvement scoring, but MIPS already has bonuses to reward 
end-to-end electronic reporting and high priority measures. We do not 
believe it would be appropriate to reward changes in the quality 
performance due to these bonuses.
    Final Action: As a result of the public comments, we are finalizing 
as proposed to amend the regulatory text at Sec.  414.1380(b)(1)(xvi) 
to state that improvement scoring is available to MIPS eligible 
clinicians that demonstrate improvement in performance in the current 
MIPS performance period compared to the performance in the previous 
MIPS performance period, based on measure achievement points.
    We are also finalizing as proposed to call the score at Sec.  
414.1380(b)(1)(xvi)(D), which is based on achievement only, the 
``quality performance category achievement percent score,'' which is 
calculated using the formula as proposed.
(v) Improvement Scoring Methodology for the Quality Performance 
Category
    We noted that we believe the improvement scoring methodology that 
we are proposing for the quality performance category recognizes the 
rate of increase in quality performance category scores of MIPS 
eligible clinicians from one performance period to another performance 
period so that a higher rate of improvement results in a higher 
improvement percent score. We believe this is particularly true for 
those clinicians with lower performance who will be incentivized to 
begin improving with the opportunity to increase their improvement 
significantly and achieve a higher improvement percent score.
    We proposed to award an ``improvement percent score'' based on the 
following formula:

Improvement percent score = (increase in quality performance category 
achievement percent score from prior performance period to current 
performance period/prior performance period quality performance 
category achievement percent score) *10 percent.

    In the proposed rule (82 FR 30117), we provided an example of how 
to score the improvement percent score. We noted that we believe that 
this improvement scoring methodology provides an easily explained and 
applied approach that is consistent for all MIPS eligible clinicians. 
Additionally, it provides additional incentives for MIPS eligible 
clinicians who are lower performers to improve performance. We believe 
that providing larger incentives for MIPS eligible clinicians with 
lower quality performance category scores to improve will not only 
increase the quality performance category scores but also will have the 
greatest impact on improving quality for beneficiaries.
    We also proposed that the improvement percent score cannot be 
negative (that is, lower than zero percentage points). The improvement 
percent score would be zero for those who do not have sufficient data 
or who are not eligible under our proposal for improvement points. For 
example, a MIPS eligible clinician would not be eligible for 
improvement if the clinician was not eligible for MIPS in the prior 
performance period and did not have a quality performance category 
achievement percent score. We also proposed to cap the size of the 
improvement award at 10 percentage points, which we believe 
appropriately rewards improvement and does not outweigh percentage 
points available through achievement. In effect, 10 percentage points 
under our proposed formula would represent 100 percent improvement--or 
doubling of achievement measure points--over the immediately preceding 
period. For the

[[Page 53746]]

reasons stated, we anticipated that this amount will encourage 
participation by individual MIPS eligible clinicians and groups and 
will provide an appropriate recognition and award for the largest 
increases in performance improvement.
    Table 28 of the proposed rule (82 FR 30118), and included in Table 
24, illustrated examples of the proposed improvement percent scoring 
methodology, which is based on rate of increase in quality performance 
category achievement percent scores. We also considered an alternative 
to measuring the rate of improvement. The alternative would use band 
levels to determine the improvement points for MIPS eligible clinicians 
who qualify for improvement points. Under the band level methodology, a 
MIPS eligible clinician's improvement points would be determined by an 
improvement in the quality performance category achievement percent 
score from 1 year to the next year to determine improvement in the same 
manner as set forth in the rate of improvement methodology. However, 
for the band level methodology, an improvement percent score would then 
be assigned by taking into account a portion (50, 75 or 100 percent) of 
the improvement in achievement, based on the clinician's performance 
category achievement percent score for the prior performance period. 
Bands would be set for category achievement percent scores, with 
increases from lower category achievement scores earning a larger 
portion (percentage) of the improvement points. Under this alternative, 
simple improvement percentage points for improvement are awarded to 
MIPS eligible clinicians whose category scores improved across years 
according to the band level, up to a maximum of 10 percent of the total 
score. In Table 29 of the proposed rule (82 FR 30118), we illustrated 
the band levels we considered as part of this alternative proposal. 
Table 30 of the proposed rule (82 FR 30119) illustrated examples of the 
improvement scoring methodology based on band levels. Generally, this 
methodology would generate a higher improvement percent score for 
clinicians; however, we noted that we believe the policy we proposed 
would provide a score that better represents true improvement at the 
performance category level, rather than comparing simple increases in 
performance category scores.

  Table 24--Improvement Scoring Examples Based on Rate of Increase in Quality Performance Category Achievement
                                                 Percent Scores
----------------------------------------------------------------------------------------------------------------
                               Year 1 quality  Year 2 quality
                                performance      performance
                                  category        category       Increase in        Rate of        Improvement
                                achievement      achievement     improvement      improvement     percent score
                               percent score    percent score
----------------------------------------------------------------------------------------------------------------
Individual Eligible           5% (Will                     50  20% Because the  20%/30% = 0.67.  0.67 * 10% =
 Clinician #1 (Pick your       substitute 30%                   year 1 score                      6.7% No cap
 Pace Test Option).            which is the                     is below 30%,                     needed.
                               lowest score a                   we measure
                               clinician can                    improvement
                               achieve with                     above 30%.
                               complete
                               reporting in
                               year 1.).
Individual Eligible           60%............              66  6%.............  6%/60% = 0.10..  0.10 * 10% =
 Clinician #2.                                                                                    1.0% No cap
                                                                                                  needed.
Individual Eligible           90%............              93  3%.............  3%/90% = 0.033.  0.033 * 10% =
 Clinician #3.                                                                                    0.3% No cap
                                                                                                  needed.
Individual Eligible           30%............              70  40%............  40%/30% = 1.33.  1.33 * 10% =
 Clinician #4.                                                                                    13.3% Apply
                                                                                                  cap at 10%.
----------------------------------------------------------------------------------------------------------------

    In addition, we considered another alternative that would adopt the 
improvement scoring methodology of the Shared Savings Program \7\ for 
CMS Web Interface submissions in the quality performance category, but 
decided to not adopt this approach. Under the Shared Savings Program 
approach, eligible clinicians and groups that submit through the CMS 
Web Interface would have been required to submit on the same set of 
quality measures, and we would have awarded improvement for all 
eligible clinicians or groups who submitted complete data in the prior 
performance period. As Shared Savings Program and Next Generation ACOs 
report using the CMS Web Interface, using the same improvement score 
approach would align MIPS with these other programs. We believed it 
could be beneficial to align improvement between the programs because 
it would align incentives for those who participate in the Shared 
Savings Program or ACOs. The Shared Savings Program approach would test 
each measure for statistically significant improvement or statistically 
significant decline. We would sum the number of measures with a 
statistically significant improvement and subtract the number of 
measures with a statistically significant decline to determine the Net 
Improvement. We would next divide the Net Improvement in each domain by 
the number of eligible measures in the domain to calculate the 
Improvement Score. We would cap the number of possible improvement 
percentage points at 10.
---------------------------------------------------------------------------

    \7\ For additional information on the Shared Savings Program's 
scoring methodology, we refer readers to the Quality Measurement 
Methodology and Resources, September 2016, Version 1 and the 
Medicare Shared Savings Program Quality Measure Benchmarks for the 
2016 and 2017 Reporting Years (available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/MSSP-QM-Benchmarks-2016.pdf).
---------------------------------------------------------------------------

    We considered the Shared Savings Program methodology because it 
would promote alignment with ACOs. We ultimately decided not to adopt 
this scoring methodology because we believe having a single performance 
category level approach for all quality performance category scores 
encourages a uniformity in our approach to improvement scoring and 
simplifies the scoring rules for MIPS eligible clinicians. It also 
allows us greater flexibility to compare performance scores across the 
diverse submission mechanisms, which makes improvement scoring more 
broadly available to eligible clinicians and groups that elect 
different ways of participating in MIPS.
    We proposed to add regulatory text at Sec.  
414.1380(b)(1)(xvi)(C)(3) to state that an improvement percent score 
cannot be negative (that is, lower than zero percentage points). We 
also proposed to add regulatory text at Sec.  414.1380(b)(1)(xvi)(C)(1) 
to state that improvement scoring is awarded based on the rate of 
increase in the quality performance category achievement percent score 
of individual MIPS eligible clinicians or groups from the current MIPS 
performance period compared to the score in the year immediately prior 
to the current MIPS

[[Page 53747]]

performance period. We also proposed to add regulatory text at Sec.  
414.1380(b)(1)(xvi)(C)(2) to state that an improvement percent score is 
calculated by dividing the increase in the quality performance category 
achievement percent score of an individual MIPS eligible clinician or 
group, which is calculated by comparing the quality performance 
category achievement percent score the current MIPS performance period 
to the quality performance category achievement percent score from the 
MIPS performance period in the year immediately prior to the current 
MIPS performance period, by the prior performance period quality 
performance category achievement percent score, and multiplying by 10 
percent.
    We invited public comments on our proposal to calculate improvement 
scoring using a methodology that awards improvement points based on the 
rate of improvement and, alternatively, on rewarding improvement at the 
band level or using the Shared Savings Program approach for CMS Web 
Interface submissions.
    The following is a summary of the public comments received on our 
proposal for the methodology to calculate improvement of the quality 
performance category and our response:
    Comment: Many commenters supported the proposed rate of increase 
for measuring improvement. Several commenters believed it is fairer and 
easier to understand the rate of improvement instead of the improvement 
at the band level. One commenter believed that the proposed methodology 
more accurately captures improvement levels than the band level 
methodology and would provide more equivalent scoring because the band 
level methodology provides less opportunity to improve scores for high 
performers. One commenter believed the band level and the Shared 
Savings Program approach for CMS Web Interface submissions are too 
complex. One commenter believed the rate of improvement appropriately 
incentivizes lower performers to improve their performance. One 
commenter believed the proposed approach redresses inadvertent biases 
that would otherwise disadvantage smaller specialty, rural, and other 
professionals.
    Response: We appreciate the commenters' support for our proposal.
    Comment: One commenter suggested adjustments in future years based 
on an analysis of the impact of the current proposal on practices and 
their ability to ramp up to full reporting.
    Response: We will monitor the impact of the rate of increase 
methodology on the quality performance category scores and address any 
changes through future rulemaking.
    Comment: One commenter believed that the rate of improvement mainly 
benefits lower performers who show improvement. One commenter believed 
that the proposed methodology disadvantages clinicians who are already 
performing well in the program. One commenter believed that this 
approach might discourage high-performing practices from continuing to 
invest in their practices to achieve small, incremental, yet vital 
improvements in quality. One commenter requested an alternative 
approach that would more equitably incentivize clinicians at all-stages 
of practice transformation to value-based care and to continuously 
improve their performance.
    Response: While we understand the commenter's concerns, we believe 
the improvement methodology provides an adequate incentive and award 
for improvement in performance for high performers and low performers 
and encourages movement toward value-based care. Improvement is 
available to all clinicians, although initially the chance to improve 
is higher for those who either low-performers or those who have not 
participated before. We believe that increasing the scores for those 
who raise their performance level at a greater rate will have the 
greatest impact on quality for beneficiaries.
    Comment: A few commenters supported the band methodology over the 
proposed methodology for calculating improvement because clinicians 
with high performance who demonstrate even modest improvement should 
benefit from improvement scoring.
    Response: We agree that the band methodology is a viable approach; 
however, given the general support for our proposal, we are finalizing 
our proposal of using rate of increase in achievement.
    Final Action: As a result of the public comments, we are finalizing 
as proposed to base the improvement percent score on the rate of 
increase in achievement methodology. We are finalizing as proposed to 
add requirements at Sec.  414.1380(b)(1)(xvi)(C)(3) to state that an 
improvement percent score cannot be negative (that is, lower than zero 
percentage points). We also are finalizing as proposed to add a 
requirement at Sec.  414.1380(b)(1)(xvi)(C)(1) to state that 
improvement scoring is awarded based on the rate of increase in the 
quality performance category achievement percent score of individual 
MIPS eligible clinicians from the previous performance period to the 
current performance period. We also are finalizing as proposed to add 
requirements at Sec.  414.1380(b)(1)(xvi)(C)(2) to state that an 
improvement percent score is calculated by dividing the increase in the 
quality performance category achievement percent score of an individual 
MIPS eligible clinician or group, which is calculated by comparing the 
quality performance category achievement percent score from the prior 
performance period to the current performance period, by the prior 
performance period's quality performance category achievement percent 
score, and multiplying by 10 percent.
(j) Calculating the Quality Performance Category Percent Score 
Including Improvement
    In the CY 2017 Quality Payment Program final rule, we finalized at 
Sec.  414.1380(b)(1)(xv) that the quality performance category score is 
the sum of all points assigned for the measures required for the 
quality performance category criteria plus bonus points, divided by the 
sum of total possible points (81 FR 77300). Using the terminology 
proposed in section II.C.7.a.(2) of the proposed rule (82 FR 30098 
through 30099), this formula can be represented as:

Quality performance category percent score = (total measure achievement 
points + measure bonus points)/total available measure achievement 
points.

    We proposed to incorporate the improvement percent score, which was 
proposed in section II.C.7.a.(2)(i)(i) of the proposed rule (82 FR 
30113 through 30114), into the quality performance category percent 
score. We proposed to amend Sec.  414.1380(b)(1)(xv) (redesignated as 
Sec.  414.1380(b)(1)(xvii)) to add the improvement percent score (as 
calculated pursuant to proposed paragraph (b)(1)(xvi)(A) through (F)) 
to the quality performance score. We also proposed to amend Sec.  
414.1380(b)(1)(xv) (redesignated as Sec.  414.1380(b)(1)(xvii)) to 
amend the text that states the quality performance category percent 
score cannot exceed the total possible points for the quality 
performance category to clarify that the total possible points for the 
quality performance category cannot exceed 100 percentage points. Thus, 
the calculation for the proposed quality performance category percent 
score including improvement, can be summarized in the following 
formula:


[[Page 53748]]


Quality performance category percent score = ([total measure 
achievement points + measure bonus points]/total available measure 
achievement points) + improvement percent score, not to exceed 100 
percent.

    This same formula and logic will be applied for both CMS Web 
Interface and Non-CMS Web Interface reporters.
    Table 31 of the proposed rule (82 FR 30120) illustrated an example 
of calculating the quality performance category percent score including 
improvement for a non-CMS Web Interface reporter. We noted that the 
quality performance category percent score is then multiplied by the 
performance category weight for calculating the points towards the 
final score.
    We invited public comment on this overall methodology and formula 
for calculating the quality performance category percent score.
    The following is a summary of the public comments received on the 
``Calculating the Quality Performance Category Percent Score Including 
Improvement'' proposals and our responses:
    Comment: Several commenters supported the quality category 
improvement scoring formula.
    Response: We appreciate the commenters' support of our proposal.
    Final Action: As a result of the public comments, we are finalizing 
as proposed to incorporate the improvement percent score, which was 
proposed in section II.C.7.a.(2)(i)(i) of the proposed rule (see 82 FR 
30113 through 30114), into the quality performance category percent 
score. We are also finalizing as proposed to amend Sec.  
414.1380(b)(1)(xv) (redesignated as Sec.  414.1380(b)(1)(xvii)) to add 
the improvement percent score (as calculated pursuant to proposed 
paragraph (b)(1)(xvi)(A) through (F)) to the quality performance score. 
We are also finalizing as proposed to amend Sec.  414.1380(b)(1)(xv) 
(redesignated as Sec.  414.1380(b)(1)(xvii) to amend the text that 
states the quality performance category percent score cannot exceed the 
total possible points for the quality performance category to clarify 
that the total possible points for the quality performance category 
cannot exceed 100 percentage points.
(3) Scoring the Cost Performance Category
    We score the cost performance category using a methodology that is 
generally consistent with the methodology used for the quality 
performance category. In the CY 2017 Quality Payment Program final rule 
(81 FR 77309), we codified at Sec.  414.1380(b)(2) that a MIPS eligible 
clinician receives 1 to 10 achievement points for each cost measure 
attributed to the MIPS eligible clinician based on the MIPS eligible 
clinician's performance compared to the measure benchmark. We establish 
a single benchmark for each cost measure and base those benchmarks on 
the performance period (81 FR 77309). Because we base the benchmarks on 
the performance period, we will not be able to publish the actual 
numerical benchmarks in advance of the performance period (81 FR 
77309). We develop a benchmark for a cost measure only if at least 20 
groups (for those MIPS eligible clinicians participating in MIPS as a 
group practice) or TIN/NPI combinations (for those MIPS eligible 
clinicians participating in MIPS as an individual) can be attributed 
the case minimum for the measure (81 FR 77309). If a benchmark is not 
developed, the cost measure is not scored or included in the 
performance category (81 FR 77309). For each set of benchmarks, we 
calculate the decile breaks based on cost measure performance during 
the performance period and assign 1 to 10 achievement points for each 
measure based on which benchmark decile range the MIPS eligible 
clinician's performance on the measure is between (81 FR 77309 through 
77310). We also codified at Sec.  414.1380(b)(2)(iii) that a MIPS 
eligible clinician's cost performance category score is the equally-
weighted average of all scored cost measures (81 FR 77311).
    In the CY 2017 Quality Payment Program final rule (81 FR 77311), we 
adopted a final policy to not calculate a cost performance category 
score if a MIPS eligible clinician or group is not attributed any cost 
measures because the MIPS eligible clinician or group has not met the 
case minimum requirements for any of the cost measures or a benchmark 
has not been created for any of the cost measures that would otherwise 
be attributed to the clinician or group. We inadvertently failed to 
include this policy in the regulation text and proposed to codify it 
under Sec.  414.1380(b)(2)(v) (82 FR 30120).
    For more of the statutory background and descriptions of our 
current policies for the cost performance category, we refer readers to 
the CY 2017 Quality Payment Program final rule (81 FR 77308 through 
77311).
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30098), 
we proposed to add improvement scoring to the cost performance category 
scoring methodology starting with the 2020 MIPS payment year. We did 
not propose any changes to the methodology for scoring achievement in 
the cost performance category for the 2020 MIPS payment year other than 
the method used for facility-based measurement described in the CY 2018 
Quality Payment Program proposed rule (82 FR 30128 through 30132). We 
proposed a change in terminology to refer to the ``cost performance 
category percent score'' in order to be consistent with the terminology 
used in the quality performance category (82 FR 30120). We proposed to 
revise Sec.  414.1380(b)(2)(iii) to provide that a MIPS eligible 
clinician's cost performance category percent score is the sum of the 
following, not to exceed 100 percent: The total number of achievement 
points earned by the MIPS eligible clinician divided by the total 
number of available achievement points (which can be expressed as a 
percentage); and the cost improvement score (82 FR 30121). This 
terminology change to refer to the score as a percentage is consistent 
with the proposed change in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30099) for the quality performance category. We 
discussed the proposals for improvement scoring in the cost performance 
category in of the CY 2018 Quality Payment Program proposed rule (82 FR 
30121).
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters supported the addition of improvement 
scoring in the cost performance category, noting that it was consistent 
with the statutory requirements.
    Response: We thank the commenters for their support.
    Comment: Several commenters opposed the proposal to add improvement 
scoring in the cost performance category for the 2020 MIPS payment 
year. Many of these commenters expressed concern with the measures used 
in the cost performance category, suggesting that the measures were not 
well suited to determine achievement and therefore not suitable to 
determine improvement. A few commenters recommended that clinicians be 
given more time to understand cost measures before assessing 
improvement. A few commenters expressed concern that this increased the 
complexity of scoring in the cost performance category. A few 
commenters suggested that improvement scoring should not be added until 
episode-based measures were included as cost measures.
    Response: We understand the concerns with adding improvement 
scoring to the cost performance

[[Page 53749]]

category. We have recognized that clinicians still need time to better 
understand cost measures, as well as our method of scoring them. Under 
our proposed methodology for scoring improvement, only two cost 
measures would be eligible for improvement scoring for the 2018 MIPS 
performance period. Many clinicians will not be scored on those two 
cost measures because they will not meet the case minimums for either 
of those measures due to the nature of their specialty or practice. 
However, section 1848(q)(5)(D)(i)(I) of the Act compels us to take 
improvement into account in addition to achievement in scoring the cost 
performance category beginning with the second year of MIPS, if data 
sufficient to measure improvement is available.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to add improvement scoring to the cost 
performance category scoring methodology starting with the 2020 MIPS 
payment year. We are finalizing our proposal to change the terminology 
to refer to a cost performance category percent score and to make 
corresponding changes to the regulation text at Sec.  
414.1380(b)(2)(iii). We are also finalizing our proposal to add 
regulatory text at Sec.  414.1380(b)(2)(v) reflecting our previously 
finalized policy not to calculate a cost performance category score if 
a MIPS eligible clinician or group is not attributed any cost measures 
because the MIPS eligible clinician or group has not met the case 
minimum requirements for any of the cost measures or a benchmark has 
not been created for any of the cost measures that would otherwise be 
attributed to the clinician or group.
(a) Measuring Improvement
(i) Calculating Improvement at the Cost Measure Level
    In the CY 2018 Quality Payment Program proposed rule (82 FR XXX), 
we proposed to make available to MIPS eligible clinicians and groups a 
method of measuring improvement in the quality and cost performance 
categories. In the CY 2018 Quality Payment Program proposed rule (82 FR 
30113 through 30114), for the quality performance category, we proposed 
to assess improvement on the basis of the score at the performance 
category level. For the cost performance category, similar to the 
quality performance category, we proposed at Sec.  414.1380(b)(2)(iv) 
that improvement scoring is available to MIPS eligible clinicians and 
groups that demonstrate improvement in performance in the current MIPS 
performance period compared to their performance in the immediately 
preceding MIPS performance period (for example, demonstrating 
improvement in the 2018 MIPS performance period over the 2017 MIPS 
performance period).
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30113 
through 30114), we noted the various challenges associated with 
attempting to measure improvement in the quality performance category 
at the measure level, given the many opportunities available to 
clinicians to select which measures to report. We noted that these 
challenges are not present in the cost performance category and 
explained our reasons for believing that there are advantages to 
measuring cost improvement at the measure level. Therefore, we proposed 
at section Sec.  414.1380(b)(2)(iv)(A) to measure cost improvement at 
the measure level for the cost performance category.
    In the CY 2018 Quality Payment Program proposed rule, we described 
our reasons for believing that we would have data sufficient to measure 
improvement when we can measure performance in the current performance 
period compared to the prior performance period. Due to the differences 
in our proposals for measuring improvement for the quality and cost 
performance categories, such as measuring improvement at the measure 
level versus the performance category level, we proposed a different 
data sufficiency standard for the cost performance category than for 
the quality performance category. First, for data sufficient to measure 
improvement to be available for the cost performance category, we 
proposed that the same cost measure(s) would need to be specified for 
the cost performance category for 2 consecutive performance periods (82 
FR 30121). For the 2020 MIPS payment year, only 2 cost measures, the 
MSPB measure and the total per capita cost measure, would be eligible 
for improvement scoring under this proposal. For a measure to be scored 
in either performance period, a MIPS eligible clinician would need to 
have a sufficient number of attributed cases to meet or exceed the case 
minimum for the measure.
    In addition, we proposed that a clinician would have to report for 
MIPS using the same identifier (TIN/NPI combination for individuals, 
TIN for groups, or virtual group identifiers for virtual groups) and be 
scored on the same measure(s) for 2 consecutive performance periods (82 
FR 30121). Because we wanted to encourage action on the part of 
clinicians in reviewing and understanding their contribution to patient 
costs, we believed that improvement should be evaluated only when there 
is a consistent identifier.
    Therefore, for the cost performance category, we proposed at Sec.  
414.1380(b)(2)(iv)(B) that we would calculate a cost improvement score 
only when data sufficient to measure improvement is available (82 FR 
30121). We proposed that sufficient data would be available when a MIPS 
eligible clinician participates in MIPS using the same identifier in 2 
consecutive performance periods and is scored on the same cost 
measure(s) for 2 consecutive performance periods (for example, in the 
2017 MIPS performance period and the 2018 MIPS performance period) (82 
FR 30121). If the cost improvement score cannot be calculated because 
sufficient data is not available, we proposed to assign a cost 
improvement score of zero percentage points (82 FR 30121). While the 
total available cost improvement score would be limited at first 
because only 2 cost measures would be included in both the first and 
second performance periods of the program (total per capita cost and 
MSPB), more opportunities for improvement scoring would be available in 
the future as additional cost measures, including episode-based 
measures, are added in future rulemaking. MIPS eligible clinicians 
would be able to review their performance feedback and make 
improvements compared to the score in their previous feedback.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters supported our proposal to evaluate 
improvement for the cost performance category at the measure level 
because the measures are likely to remain consistent over time and this 
approach may enable clinicians the ability to target process 
improvements on a specific measurement that results in improved 
performance.
    Response: We thank the commenters for their support.
    Comment: A few commenters suggested that data sufficient to measure 
improvement in the cost performance category would not be available, 
and therefore we are not required to consider improvement in 
determining the cost performance category score. These commenters 
suggested that sufficient data would not be available because we did 
not propose to retain for the 2020 MIPS payment year the episode-based 
measures used for the 2019 MIPS payment year and that new

[[Page 53750]]

episode-based measures could be added for the 2021 MIPS payment year. 
One commenter suggested that sufficient data would not be available to 
measure improvement for specialist clinicians because episode-based 
measures would not be available for all clinicians.
    Response: We continue to believe that data sufficient to measure 
improvement will be available under our proposed methodology for 
measuring improvement for the cost performance category. Under our 
proposal, we would measure improvement only when a MIPS eligible 
clinician participates in MIPS using the same identifier in two 
consecutive performance periods and is scored on the same cost 
measure(s) for two consecutive performance periods. This same policy 
would apply as we continue to implement our plan to introduce new 
episode-based measures in future years of the program. We note measures 
would not be eligible for improvement scoring in the first year they 
are adopted for MIPS, as we would have no way of assessing how a 
clinician might have improved on a measure that was not previously 
included in the program.
    Comment: Several commenters supported our proposal to measure 
improvement in the cost performance category if a clinician is scored 
on the same measure and with the same group or individual identifier in 
subsequent years.
    Response: We thank the commenters for their support.
    Comment: A few commenters opposed our approach to measuring 
improvement in the cost performance category at the measure level, 
suggesting that the approach proposed for the quality performance 
category would be simpler and better understood by clinicians, and 
having more than one method of evaluating improvement is confusing.
    Response: We strive to maintain consistency and simplicity in the 
Quality Payment Program to the greatest extent possible. However, we 
continue to believe that the methods for measuring achievement in the 
quality and cost performance categories are different enough to warrant 
a different approach for measuring improvement. Most importantly, 
clinicians are not given the opportunity to select the measures in the 
cost performance category, as they are in the quality performance 
category, so there should be greater consistency in the measures on 
which clinicians are assessed from year to year. One benefit to scoring 
improvement at the cost measure level is that clinicians who wish to 
take action to improve their performance can focus on a particular 
measure as opposed to an overall category score that may represent 
multiple measures.
    Comment: One commenter opposed our proposal to measure improvement 
only when a clinician participates in MIPS using the same identifier 
(TIN/NPI combination for individuals, TIN for groups, or virtual group 
identifiers for virtual groups) for two consecutive performance 
periods. This commenter suggested that some clinicians work in multiple 
practices in a year and that this requirement would limit their 
opportunity to receive an improvement score.
    Response: We wish to encourage action on the part of clinicians in 
reviewing and understanding their contribution to patient costs. We 
believe an approach that evaluates improvement only for those who 
report using the same identifier in consecutive years is more likely to 
reward targeted improvement by the clinician or group. A clinician who 
reported as part of a group in 1 year and as an individual in another 
year would be likely to have a different patient population and other 
factors that could affect the improvement score. In the case of 
clinicians who work at more than one practice (and bill under more than 
one TIN) in a given year and continue at those practices in future 
years, they could be scored on their improvement if they continue to 
participate in MIPS using the same practice identifier from year to 
year.
    Final Action: After consideration of the public comments, we are 
finalizing all of these proposals related to measuring improvement in 
the cost performance category at the measure level.
(ii) Improvement Scoring Methodology
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30096 
through 30097), we discussed a number of different programs and how 
they measure improvement at the category or measure level as part of 
their scoring systems. In the proposed method for the quality 
performance category, we proposed to compare the overall rate of 
achievement on all the underlying measures in the quality performance 
category and measure a rate of overall improvement to calculate an 
improvement percent score. We then add the improvement percent score 
after taking into account measure achievement points and measure bonus 
points as described in proposed Sec.  414.1380(b)(1)(xvii). In 
reviewing the methodologies that are specified in the CY 2018 Quality 
Payment Program proposed rule that include consideration of improvement 
at the measure level, we noted that the methodology used in the Shared 
Savings Program would best reward achievement and improvement for the 
cost performance category because this program includes measures for 
clinicians, the methodology is straightforward, and it only recognizes 
significant improvement (82 FR 30122). We proposed to quantify 
improvement in the cost performance category by comparing the number of 
cost measures with significant improvement in performance and the 
number of cost measures with significant declines in performance (82 FR 
30122). We proposed at Sec.  414.1380(b)(2)(iv)(C) to determine the 
cost improvement score by subtracting the number of cost measures with 
significant declines from the number of cost measures with significant 
improvement, and then dividing the result by the number of cost 
measures for which the MIPS eligible clinician or group was scored in 
both performance periods, and then multiplying the result by the 
maximum cost improvement score (82 FR 30122). For the 2020 MIPS payment 
year, improvement scoring would be possible for the total per capita 
cost measure and the MSPB measure as those 2 measures would be 
available for 2 consecutive performance periods under the proposals in 
the CY 2018 Quality Payment Program proposed rule (82 FR 30122). As in 
our proposed quality improvement methodology, we proposed at Sec.  
414.1380(b)(2)(iv)(D) that the cost improvement score could not be 
lower than zero, and therefore, could only be positive (82 FR 30122).
    We proposed to determine whether there was a significant 
improvement or decline in performance between the two performance 
periods by applying a common standard statistical test, a t-test, as is 
used in the Shared Savings Program (79 FR 67930 through 67931, 82 FR 
30122). We also welcomed public comments on whether we should consider 
instead adopting an improvement scoring methodology that measures 
improvement in the cost performance category the same way we proposed 
to do in the quality performance category; that is, using the rate of 
improvement and without requiring statistical significance which was 
discussed in the CY 2018 Quality Payment Program proposed rule (82 FR 
30113 through 30114).
    Section 1848(q)(5)(D)(ii) of the Act specifies that the Secretary 
may assign a higher scoring weight under subparagraph (F) with respect 
to the achievement of a MIPS eligible clinician than with respect to 
any improvement

[[Page 53751]]

of such clinician with respect to a measure, activity, or category 
described in paragraph (2). We noted that we believe that there are 
many opportunities for clinicians to actively work on improving their 
performance on cost measures, through more active care management or 
reductions in certain services. However, we recognize that most 
clinicians are still learning about their opportunities in cost 
measurement. We noted that we aim to continue to educate clinicians 
about opportunities in cost measurement and continue to develop 
opportunities for robust feedback and measures that better recognize 
the role of clinicians. Since MIPS is still in its beginning years and 
we understand that clinicians are working hard to understand how we 
measure costs for purposes of the cost performance category, as well as 
how we score their performance in all other aspects of the program, we 
believe improvement scoring in the cost performance category should be 
limited to avoid creating additional confusion. Based on these 
considerations, we proposed in the CY 2018 Quality Payment Program 
proposed rule to weight the cost performance category at zero percent 
for the 2018 MIPS performance period/2020 MIPS payment year (82 FR 
30122). With the entire cost performance category proposed to be 
weighted at zero percent, we noted that the focus of clinicians should 
be on achievement as opposed to improvement, and therefore, we proposed 
at Sec.  414.1380(b)(2)(iv)(E) that although improvement would be 
measured according to the method described above, the maximum cost 
improvement score for the 2020 MIPS payment year would be zero 
percentage points (82 FR 30122). Section 1848(q)(5)(D)(ii) of the Act 
provides discretion for the Secretary to assign a higher scoring weight 
under subparagraph (F), which refers to section 1848(q)(5)(F) of the 
Act, with respect to achievement than with respect to improvement. 
Section 1848(q)(5)(F) of the Act provides if there are not sufficient 
measures and activities applicable and available to each type of MIPS 
eligible clinician, the Secretary shall assign different scoring 
weights (including a weight of zero) for measures, activities, and/or 
performance categories. When read together, we interpreted sections 
1848(q)(5)(D)(ii) and 1848(q)(5)(F) of the Act to provide discretion to 
the Secretary to assign a scoring weight of zero for improvement on the 
measures specified for the cost performance category. Under the 
improvement scoring methodology we proposed, we believe a maximum cost 
improvement score of zero would be effectively the same as a scoring 
weight of zero. Under this proposal, the cost improvement score would 
not contribute to the cost performance category percent score 
calculated for the 2020 MIPS payment year.
    In the CY 2018 Quality Payment Program proposed rule, we considered 
an alternative to make no changes to the previously finalized weight of 
10 percent for the cost performance category for the 2020 MIPS payment 
year. We proposed that if we maintain a weight of 10 percent for the 
cost performance category for the 2020 MIPS payment year, the maximum 
cost improvement score available in the cost performance category would 
be 1 percentage point out of 100 percentage points available for the 
cost performance category percent score (82 FR 30122). If a clinician 
were measured on only one measure consistently from one performance 
period to the next and met the requirements for improvement, the 
clinician would receive one improvement percentage point in the cost 
performance category percent score. If a clinician were measured on 2 
measures consistently, improved significantly on one, and did not show 
significant improvement on the other (as measured by the t-test method 
described above), the clinician would receive 0.5 improvement 
percentage points.
    We invited comments on these proposals, as well as alternative ways 
to measure changes in statistical significance for the cost measure.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: A few commenters supported our proposed methodology to 
determine cost improvement score on the basis of a statistical test at 
the measure level.
    Response: We thank the commenters for their support.
    Comment: A few commenters expressed concern that our proposed 
method of determining cost improvement would be unfair once multiple 
episode-based measures are included in the cost performance category 
because it would be difficult to demonstrate improvement on all 
measures. A few commenters suggested that clinicians receive credit for 
improvement in each cost measure but that declines in performance not 
be considered as part of their improvement score.
    Response: Because there will be some variability in the number of 
cost measures that are attributed to clinicians and groups, 
particularly if more measures are added in future years of the program, 
we do not believe that we can award additional credit for improvement 
for each measure without considering the total numbers of cost measures 
that are scored for an individual or group. Doing so could provide an 
advantage to an individual or group with more measures than others. We 
also believe that recognizing significant declines reduces the chance 
of rewarding random variation from year to year.
    We recognize that some clinicians will not have cost measures 
available and applicable during the 2018 MIPS performance period and, 
therefore, will be unable to demonstrate improvement in either the 2018 
or 2019 MIPS performance periods. However, we wish to reward clinicians 
who do achieve improvement and who are measured using the same 
identifier on the same measure in consecutive years. We will evaluate 
changes to the maximum cost improvement score for future years in 
future rulemaking.
    Comment: A few commenters supported the proposal for the maximum 
cost improvement score to be zero percentage points for the 2020 MIPS 
payment year because we had also proposed to set the weight for the 
cost performance category at zero percent of the final MIPS score for 
that same period.
    Response: We thank the commenters for their support. However, as 
discussed in section II.C.6.d.(2) of this final rule with comment 
period, we are not finalizing our proposal to weigh the cost 
performance category at zero percent for the 2020 MIPS payment year. 
Instead, we are adopting the alternative option to maintain a 10 
percent weight for the cost performance category. We proposed that if 
we maintain a weight of 10 percent for the cost performance category 
for the 2020 MIPS payment year, the maximum cost improvement score 
available in the cost performance category would be 1 percentage point 
out of 100 percentage points available for the cost performance 
category percent score. We believe that we should set a maximum cost 
improvement score that is higher than zero and are finalizing the 
maximum score at 1 percentage point as proposed.
    Final Action: After consideration of the public comments, we are 
finalizing all of our proposals related to the improvement scoring 
methodology for the cost performance category, with the exception of 
our proposal to set the maximum cost improvement score at 0 percentage 
points for the 2020 MIPS payment year. Because we are finalizing the 
alternative option to weight the cost

[[Page 53752]]

performance category at 10 percent of the final score for the 2020 MIPS 
payment year (see II.C.6.d.(2) of this final rule with comment period), 
we are adopting at Sec.  414.1380(b)(2)(iv)(E) our alternative of a 
maximum cost improvement score of 1 percentage point out of 100 
percentage points available for the cost performance category.
(b) Calculating the Cost Performance Category Percent Score With 
Achievement and Improvement
    For the cost performance category, we proposed to evaluate 
improvement at the measure level, unlike the quality performance 
category where we proposed to evaluate improvement at the performance 
category level. For both the quality performance category and the cost 
performance category, we proposed to add improvement to an existing 
category percent score. We noted that we believe this is the most 
straight-forward and simple way to incorporate improvement. It is also 
consistent with other Medicare programs that reward improvement.
    As noted in the CY 2018 Quality Payment Program proposed rule, we 
proposed a change in terminology to express the cost performance 
category percent score as a percentage (82 FR 30123). We proposed to 
revise Sec.  414.1380(b)(2)(iii) to provide that a MIPS eligible 
clinician's cost performance category percent score is the sum of the 
following, not to exceed 100 percent: The total number of achievement 
points earned by the MIPS eligible clinician divided by the total 
number of available achievement points (which can be expressed as a 
percentage); and the cost improvement score (82 FR 30123). With these 
two proposed changes, the formula would be:

(Cost Achievement Points/Available Cost Achievement Points) + (Cost 
Improvement Score) = (Cost Performance Category Percent Score).

    We provided an example of cost performance category scores with the 
determination of improvement and decline in Table 32 of the proposed 
rule (82 FR 30123). We invited public comments on these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter supported the proposed formula to calculate 
the cost performance category percent score with achievement and 
improvement.
    Response: We thank the commenter for the support.
    Final Action: After consideration of the public comments, we are 
finalizing the method of calculating the cost performance category 
percent score as proposed.
    In Table 25, we provide an example of cost performance category 
percent scores along with the determination of improvement or decline. 
This example is for group reporting where the group is measured on both 
the total per capita cost measure and the MSPB measure for 2 
consecutive performance periods.

           Table 25--Example of Assessing Achievement and Improvement in the Cost Performance Category
----------------------------------------------------------------------------------------------------------------
                                      Measure     Total possible
                                    achievement       measure           Significant         Significant decline
             Measure               points earned    achievement   improvement from prior  from prior performance
                                   by the group       points        performance period            period
----------------------------------------------------------------------------------------------------------------
Total per Capita Cost Measure...             8.2              10  Yes...................  No.
MSPB Measure....................             6.4              10  No....................  No.
                                 --------------------------------
    Total.......................            14.6              20  N/A...................  N/A.
----------------------------------------------------------------------------------------------------------------

    In this example, there are 20 total possible measure achievement 
points and 14.6 measure achievement points earned by the group, and the 
group improved on one measure but not the other, with both measures 
being scored in each performance period. The first part of the formula 
is calculating (Cost Achievement Points/Available Cost Achievement 
Points) which is 14.6/20, which equals .730 and can be represented as 
73.0 percent. The cost improvement score will be determined as follows: 
((1 measure with significant improvement-zero measures with significant 
decline)/2 measures) * 1 percentage point = 0.5 percentage points. 
Under the formula, the cost performance category percent score will be 
(14.6/20 or 73.0 percent) + 0.5 percent = 73.5 percent. To determine 
how many points the cost performance category contributes to the final 
score, we will multiply the performance category percent score (73.5 
percent) by the weight of the cost performance category (10 percent of 
the final score) and by 100 to determine the points to the final score. 
The group would have 73.5 percent x 10 percent x 100 = 7.35 points for 
the cost performance category contributed towards the final score.
(4) Facility-Based Measures Scoring Option for the 2020 MIPS Payment 
Year for the Quality and Cost Performance Categories
(a) Background
    Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary 
may use measures used for payment systems other than for physicians, 
such as measures for inpatient hospitals, for purposes of the quality 
and cost performance categories. However, the Secretary may not use 
measures for hospital outpatient departments, except in the case of 
items and services furnished by emergency physicians, radiologists, and 
anesthesiologists. In the MIPS and APMs RFI (80 FR 59108), we sought 
comment on how we could best use this authority. We refer readers to 
the CY 2017 Quality Payment Program final rule (81 FR 77127) for a 
summary of these comments.
    As noted in the CY 2017 Quality Payment Program proposed rule (81 
FR 28192), we considered 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. However, we did 
not propose an option for the transition year of MIPS because there 
were several operational considerations that we believed needed to be 
addressed before this option could be implemented. At that time, we 
requested comments on the following issues: (1) Whether we should 
attribute a facility's performance to a MIPS eligible clinician for 
purposes of the 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

[[Page 53753]]

criteria for attributing a facility's performance to a MIPS eligible 
clinician for purposes of the quality and cost performance categories; 
(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 an individual MIPS eligible 
clinician or group should elect for it to be done and choose the 
facilities through a registration process. We summarized the comments 
on these questions in the proposed rule (82 FR 30123 through 30124).
(b) Facility-Based Measurement
    We believe that facility-based measurement is intended to reduce 
reporting burden on facility-based MIPS eligible clinicians by 
leveraging existing quality data sources and value-based purchasing 
experiences and aligning incentives between facilities and the MIPS 
eligible clinicians who provide services there. In addition, we believe 
that facility-based MIPS eligible clinicians contribute substantively 
to their respective facilities' performance on facility-based measures 
of quality and cost, and that their performance may be better reflected 
by their facilities' performance on such measures.
    We proposed to limit facility-based reporting to the inpatient 
hospital in the first year for a number of reasons, including that 
there is a more diverse group of clinicians (and specialty types) 
providing services in an inpatient setting compared to other settings 
and that the Hospital Value-Based Purchasing (VBP) Program adjusts 
payment in connection with both increases and decreases in performance. 
The Hospital VBP Program is large and mature (82 FR 30124). We also 
proposed to only use measures from a pay-for-performance program and 
not a pay-for-reporting program and proposed to limit the measures for 
facility-based measurement to those used in the Hospital VBP Program 
(82 FR 30124) because it compares facilities on a series of different 
measures intended to capture the breadth of care in the facility.
    We also considered program timing when determining what Hospital 
VBP Program year to use for facility-based measurement for the 2020 
MIPS payment year. Quality measurement for the FY 2019 Hospital VBP 
Program's performance period will be concluded by December 31, 2017 (we 
refer readers to the finalized FY 2019 performance periods in the FY 
2018 Inpatient Prospective Payment System/Long-Term Care Hospital 
Prospective Payment System final rule (82 FR 38259 through 38260)), and 
the Hospital VBP Program scoring reports (referred to as the Percentage 
Payment Summary Reports) will be provided to participating hospitals 
not later than 60 days prior to the beginning of FY 2019, pursuant to 
the Hospital VBP Program's statutory requirement at section 1886(o)(8) 
of the Act. We discuss eligibility for facility-based measurement in 
the CY 2018 Quality Payment Program proposed rule (82 FR 30125 through 
30126), and we noted that the determination of the applicable hospital 
will be made on the basis of a period that overlaps with the applicable 
Hospital VBP Program performance period. Although Hospital VBP Program 
measures have different measurement periods, the FY 2019 measures all 
overlap from January to June in 2017, which also overlaps with our 
first 12-month period to determine MIPS eligibility for purposes of the 
CY 2018 performance period and 2020 MIPS payment year.
    We believe that MIPS eligible clinicians electing the facility-
based measurement option under MIPS should be able to consider as much 
information as possible when making that decision, including how their 
attributed hospital performed in the Hospital VBP Program because an 
individual clinician is a part of the clinical team in the hospital, 
rather than the sole clinician responsible for care as tracked by 
quality measures. Therefore, we concluded that we should be as 
transparent as possible with MIPS eligible clinicians about their 
potential facility-based scores before they begin data submission for 
the MIPS performance period since this policy option is intended to 
minimize reporting burdens on clinicians that are already participating 
in quality improvement efforts through other CMS programs. We expect 
that MIPS eligible clinicians that would consider facility-based 
scoring would generally be aware of their hospital's performance on its 
quality measures, but believe that providing this information directly 
to clinicians ensures that such clinicians are fully aware of the 
implications of their scoring elections under MIPS. However, we noted 
that this policy could conceivably place non-facility-based MIPS 
eligible clinicians at a competitive disadvantage since they would not 
have any means by which to ascertain their MIPS measure scores in 
advance. We viewed that compromise as a necessity to maximize 
transparency, and we requested comment on whether this notification in 
advance of the conclusion of the MIPS performance period is 
appropriate, or if we should consider notifying facility-based 
clinicians later in the MIPS performance period or even after its 
conclusion.
    The performance periods proposed in the CY 2018 Quality Payment 
Program proposed rule (82 FR 30034) for the 2020 MIPS payment year 
occur in part in 2018, with data submission for most mechanisms 
starting in January 2019. To provide potential facility-based scores to 
clinicians by the time the data submission period for the 2018 MIPS 
performance period begins (assuming that timeframe is operationally 
feasible), we noted that we believe that the FY 2019 Hospital VBP 
Program, including the corresponding performance periods, is the most 
appropriate program year to use for purposes of facility-based 
measurement under the quality and cost performance categories for the 
2020 MIPS payment year. However, we noted also that Hospital VBP 
Program performance periods can run for periods as long as 36 months, 
and for some FY 2019 Hospital VBP Program measures, the performance 
period begins in 2014. We requested comment on whether this lengthy 
performance period duration should outweigh our desire to include all 
Hospital VBP Program measures as discussed further below (82 FR 30125). 
We proposed at Sec.  414.1380(e)(6)(iii) that the performance period 
for facility-based measurement is the performance period for the 
measures for the measures adopted under the value-based purchasing 
program of the facility of the year specified (82 FR 30125).
    We considered whether we should include the entire set of Hospital 
VBP Program measures for purposes of facility-based measurement under 
MIPS or attempt to differentiate those which may be more influenced by 
clinicians' contribution to quality performance than others. However, 
we believe that clinicians have a broad and important role as part of 
the healthcare team at a hospital and that attempting to differentiate 
certain measures undermines the team-based approach of facility-based 
measurement. We proposed at Sec.  414.1380(e)(6)(i) that the quality 
and cost measures are those adopted under the value-based purchasing 
program of the facility program for the year specified (82 FR 30125).
    We proposed for the 2020 MIPS payment year to include all the 
measures adopted for the FY 2019 Hospital VBP Program on the MIPS list 
of quality measures and cost measures (82 FR 30125). Under the 
proposal, we considered the FY 2019 Hospital VBP Program measures to 
meet the definition

[[Page 53754]]

of additional system-based measures provided in section 
1848(q)(2)(C)(ii) of the Act, and we proposed at Sec.  
414.1380(e)(1)(i) that facility-based measures available for the 2018 
MIPS performance period are the measures adopted for the FY 2019 
Hospital VBP Program year authorized by section 1886(o) of the Act and 
codified in our regulations at Sec. Sec.  412.160 through 412.167 (82 
FR 30125). Measures in the FY 2019 Hospital VBP Program have different 
performance periods as noted in Table 33 of the CY 2018 Quality Payment 
Program proposed rule.
    We requested comments on these proposals. We also requested 
comments on what other programs, if any, we should consider including 
for purposes of facility-based measurement under MIPS in future program 
years (82 FR 30125).
    The following is a summary of the public comments received on the 
``Facility-Based Measurement'' proposals and our responses:
    Comment: Many commenters supported our proposal to offer the 
opportunity for facility-based measurement for purposes of determining 
the quality and cost performance category scores for the 2020 MIPS 
payment year. These commenters noted their longstanding interest in 
such an opportunity and stated that it would reduce burden and align 
incentives between facilities and clinicians who provide a substantial 
amount of services there.
    Response: We thank the commenters for their support. We agree that 
facility-based measurement is important and a step forward in alignment 
of incentives between clinicians and facilities. As we discuss below, 
we believe that it is prudent to delay implementation of facility-based 
measurement for an additional year so that clinicians better understand 
the opportunity and ensure that we are operationally ready to support 
this measurement option.
    Comment: A few commenters expressed general support for the idea of 
facility-based measurement but concern that they did not have enough 
information or preparation to adequately understand the proposal. These 
commenters recommended that CMS develop a 1-year pilot program and 
inform clinicians more about their status.
    Response: We acknowledge the commenters' concerns. In order to 
increase understanding of the policy, better educate clinicians on 
eligibility and applicability of the program, and ensure CMS's 
operational readiness to offer this measurement option to clinicians, 
we plan to delay implementation of this policy by 1 year.
    Comment: Many commenters recommended that eligibility for facility-
based measurement be expanded to include a wide range of facilities. 
Commenters recommended that facility-based measurement be extended in 
the future to include inpatient rehabilitation facilities, skilled 
nursing facilities, hospice programs, critical access hospitals, 
hospital outpatient departments, and ambulatory surgical centers.
    Response: As we stated in the proposed rule, we believe that 
clinicians play an important role in many facilities and programs that 
include quality reporting elements and value-based purchasing program. 
Because we believe that the program used for the inpatient hospital is 
the largest and among the most established value-based purchasing 
programs, we have proposed, and are finalizing, that clinicians 
practicing in the inpatient hospital will be eligible for facility-
based measurement. As discussed in more detail below, this final rule 
will be applicable beginning with the 2019 MIPS performance period and 
2021 MIPS payment year. However, in the future we will consider 
opportunities to expand the program to other facilities, based on the 
status of the facility value-based purchasing program, the 
applicability of measures, and the ability to appropriately attribute a 
clinician to a facility. Any new settings for facility-based 
measurement would be proposed in future rulemaking.
    Comment: A few commenters expressed concern that the facility-based 
measurement would not be applicable to certain clinicians who are not 
MIPS eligible because they are excluded by statute or bill under a 
facility provider identification number. These commenters suggested 
that we develop options to allow for these clinicians to participate in 
facility-based measurement.
    Response: MIPS eligibility is discussed in section II.C.1 of this 
final rule with comment period. Eligibility for MIPS must be 
established at the individual or group level in order for facility-
based measurement to also be applicable. We do not believe we have the 
authority to determine MIPS eligibility through facility-based 
measurement. We note that certain clinicians practice primarily in an 
FQHC or CAH but bill for some items and services under Part B. Those 
clinicians, even though they typically bill for services through an 
FQHC or CAH, could be eligible for MIPS on the basis of their other 
billing.
    Comment: Several commenters supported our plan to inform clinicians 
about their eligibility for facility-based measurement and which 
hospital their score would be based on during the MIPS performance 
period. A few commenters recommended that facilities be informed of 
which clinicians could have their scores based on that facility as 
well. These commenters expressed that informing clinicians and 
hospitals of their status would allow clinicians to make the best 
decisions for MIPS participation for their practices and increase 
alignment between facilities and clinicians.
    Response: We agree with the commenters and intend to provide as 
much information as possible as early as possible to clinicians about 
their eligibility and the hospital performance upon which a MIPS 
eligible clinician's score would be based. We will work to provide 
information about facility-based measurement eligibility and facility 
attribution to clinicians in 2018, if technically feasible. We will 
investigate whether it would be technically feasible and appropriate to 
distribute information to attributed facilities about the clinicians 
that could elect attribution of facility performance measures for 
purposes of the MIPS program.
    Comment: One commenter opposed our plan to notify clinicians about 
their facility-based status before the close of the MIPS performance 
period because the commenter noted that this choice should be made 
earlier rather than to make up for a failure to report in another 
fashion.
    Response: Although we understand the commenter's concerns, we 
disagree that an earlier deadline will be beneficial. We also need to 
balance the issue of informing clinicians of their eligibility and 
giving them an opportunity to consider their options.
    Comment: A few commenters requested clarification on whether the 
facility-based measurement would apply to the advancing care 
information or improvement activity performance categories.
    Response: Clinicians that participate in facility-based measurement 
will have their scores in the quality and cost performance categories 
determined on the basis of the performance of that facility. However, 
we did not propose that those scored under facility-based measurement 
would have different requirements for the advancing care information or 
improvement activities performance categories. Clinicians or groups 
would still be scored based on their own performance (not a facility's 
performance) on those performance

[[Page 53755]]

categories unless other exclusions apply. In addition, section 
1848(q)(2)(C)(ii) of the Act states that we may use measures used for a 
payment system other than that used for physicians for the purposes of 
the quality and cost performance categories, but does not address the 
advancing care information and improvement activities performance 
categories.
    Comment: A few commenters expressed concern that offering facility-
based measurement could distract from other quality improvement 
efforts, such as those that use registries or QCDRs. One commenter 
expressed concern that offering facility-based measurement could 
disadvantage those who are not offered the opportunity to participate 
in facility-based measurement.
    Response: One of our primary goals in structuring the Quality 
Payment Program is to allow clinicians as much flexibility as possible. 
We view the option of facility-based measurement as advancing that 
goal. As noted in the 2018 Quality Payment Program proposed rule (82 FR 
30124), we have heard concerns that clinicians who work in certain 
facilities would be more accurately measured in the context of those 
facilities and that separately identifying and reporting quality 
measures could distract from the broader quality mission of the 
facility while adding administrative burden on clinicians. We agree 
with that statement. For those clinicians who may meet our definition 
of facility-based and find that the measurement does not reflect their 
practice, there are other opportunities to submit quality measures 
data. For those for which facility-based measurement is not available, 
we continue to work to offer as much flexibility in measurement as 
possible. We have very clearly heard that facility-based measurement 
should not be mandatory and have made it an option for those who are 
eligible.
    Comment: A few commenters recommended that rather than developing a 
new system of assessing facility-based clinicians based on the 
performance of a facility that those clinicians instead be made exempt 
from the MIPS program.
    Response: MIPS eligibility is determined based on the requirements 
of section 1848(q)(2)(C) of the Act and discussed in section II.C.1 of 
this final rule with comment period. We do not believe we have the 
authority to exempt clinicians that are otherwise eligible for MIPS 
from the Quality Payment Program based on their eligibility for 
facility-based measurement.
    Final Action: After consideration of the public comments, we are 
finalizing our proposals on the general availability of facility-based 
measurement with the modification that facility-based measurement will 
not be available for clinicians until the 2019 MIPS performance period/
2021 MIPS payment year. We are finalizing regulation text at Sec.  
414.1380(e) that provides that for payment in the 2021 MIPS payment 
year and subsequent years, a MIPS eligible clinician or group may elect 
to be scored in the quality and cost performance categories using 
facility-based measures. We discuss the measures used to determine 
facility-based measurement in section II.C.7.a.(4)(f) of this final 
rule with comment period, but are finalizing our proposals and our 
proposal at Sec.  414.1380(e)(6)(i) that the quality and cost measures 
are those adopted under the value-based purchasing program of the 
facility program for the year specified at Sec.  414.1380(e)(6)(iii) 
that the performance period for facility-based measurement is the 
performance period for the measures adopted under the value-based 
purchasing program of the facility of the year specified (82 FR 30125). 
We appreciate the broad support for the implementation of facility-
based measurement and the general support for many of the policies that 
are outlined below.
    However, we are concerned that we might not have the operational 
ability to inform these clinicians soon enough during the MIPS 
performance period in 2018 for them to know that they could select 
facility-based measurement as opposed to another method. We also 
believe that the comments reflect some lack of understanding of how 
elements of the policy might apply to clinicians that may qualify for 
facility-based measurement. We plan to use this additional year for 
outreach and, if technically feasible, informing clinicians if they 
would have met the requirements for facility-based measurement based on 
the finalized policy and what their scoring might have been based on an 
attributed hospital. We believe this additional year of outreach will 
best prepare clinicians to make decisions about participating in 
facility-based measurement. As discussed in section II.C.7.a.(4)(c) of 
this final rule with comment period, the use of facility-based 
measurement will be available for individual clinicians and groups. 
Therefore, we are finalizing the introductory text at Sec.  414.1380(e) 
with a minor change to refer to ``a MIPS eligible clinician or group'' 
in place of ``MIPS eligible clinicians'' in the proposed text. We 
discuss the election in section II.C.7.a.(4)(e) of this final rule with 
comment period.
(c) Facility-Based Measurement Applicability
(i) General
    The percentage of professional time a clinician spends working in a 
hospital varies considerably. Some clinicians may provide services in 
the hospital regularly, but also treat patients extensively in an 
outpatient office or another environment. Other clinicians may practice 
exclusively within a hospital. Recognizing the various levels of 
presence of different clinicians within a hospital environment, we 
proposed to limit the potential applicability of facility-based 
measurement to those MIPS eligible clinicians with a significant 
presence in the hospital.
    In the CY 2017 Quality Payment Program final rule (81 FR 77238 
through 77240), we adopted a definition of ``hospital-based MIPS 
eligible clinician'' under Sec.  414.1305 for purposes of the advancing 
care information performance category. Section 414.1305 defines 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 POS codes used in the 
HIPAA standard transaction as an inpatient hospital, on-campus 
outpatient hospital, or emergency room setting, based on Medicare Part 
B claims for a period prior to the performance period as specified by 
CMS. We considered whether we should simply use this definition to 
determine eligibility for facility-based measurement under MIPS. 
However, we expressed concern that this definition could include many 
clinicians that have limited or no presence in the inpatient hospital 
setting. We discuss the differences between the approach of defining 
hospital-based clinicians for the purposes of the advancing care 
information category and defining facility-based measurement in the CY 
2018 Quality Payment Program proposed rule. (82 FR 30125 through 30126) 
The measures used in the Hospital VBP Program are focused on care 
provided in the inpatient setting. We noted that we do not believe it 
is appropriate for a MIPS eligible clinician to use a hospital's 
Hospital VBP Program performance for MIPS scoring if the clinician did 
not provide services in the inpatient setting or in the emergency 
department, through which many inpatients arrive at the inpatient 
setting.
    We stated our belief that establishing a definition for purposes of 
facility-based measurement that is different from the hospital-based 
definition used

[[Page 53756]]

for the advancing care information category is necessary to implement 
this option. We also noted that, since we were seeking comments on 
other programs to consider including for purposes of facility-based 
measurement in future years, we believed that establishing a separate 
definition that could be expanded as needed for this purpose is 
appropriate. We proposed at Sec.  414.1380(e)(2) that a MIPS eligible 
clinician is eligible for facility-based measurement under MIPS if they 
are determined facility-based as an individual (82 FR 30126) or as a 
part of a group (82 FR 30126).
(ii) Facility-Based Measurement by Individual Clinicians
    Based on those background considerations, we proposed at Sec.  
414.1380(e)(2)(i) that a MIPS eligible clinician is considered 
facility-based as an individual if the MIPS eligible clinician 
furnishes 75 percent or more of their covered professional services (as 
defined in section 1848(k)(3)(A) of the Act) in sites of service 
identified by the POS codes used in the HIPAA standard transaction as 
an inpatient hospital, as identified by POS code 21, or an emergency 
room, as identified by POS code 23, based on claims for a period prior 
to the performance period as specified by CMS (82 FR 30126). We 
understand that the services of some clinicians who practice solely in 
the hospital are billed using place of service codes such as code 22, 
reflecting an on-campus outpatient hospital for patients who are in 
observation status. Because there are limits on the length of time a 
Medicare patient may be seen under observation status, we noted that we 
believe that these clinicians would still furnish 75 percent or more of 
their covered professional services using POS code 21, but sought 
comment on whether a lower or higher threshold of inpatient services 
would be appropriate. We did not propose to include POS code 22 in 
determining whether a clinician is facility-based because many 
clinicians who bill for services using this POS code may work on a 
hospital campus but in a capacity that has little to do with the 
inpatient care in the hospital. In contrast, we noted our belief that 
those who provide services in the emergency room or the inpatient 
hospital clearly contribute to patient care that is captured as part of 
the Hospital VBP Program because many patients who are admitted are 
admitted through the emergency room. We sought comments on whether POS 
22 should be included in determining if a clinician is facility-based 
and how we might distinguish those clinicians who contribute to 
inpatient care from those who do not. The inclusion of any POS code in 
our definition is pending technical feasibility to link a clinician to 
a facility under the method described in section II.C.7.b.(4)(d) of the 
CY 2018 Quality Payment Program proposed rule (82 FR 30126 through 
30127).
    We noted that this more limited definition would mean that a 
clinician who is determined to be facility-based likely would also be 
determined to be hospital-based for purposes of the advancing care 
information performance category, because the proposed definition of 
facility-based is narrower than the hospital-based definition 
established for that purpose. We proposed to identify clinicians as 
facility-based (and thus eligible to elect facility-based measurement) 
through an evaluation of covered professional services between 
September 1 of the calendar year 2 years preceding the performance 
period through August 31 of the calendar year preceding the performance 
period with a 30-day claims run out. For example, for the 2020 MIPS 
payment year, where we have adopted a performance period of CY 2018 for 
the quality and cost performance categories, we would use the data 
available at the end of October 2017 to determine whether a MIPS 
eligible clinician is considered facility-based under our proposed 
definition. At that time, those data would include Medicare Part B 
claims with dates of service between September 1, 2016 and August 31, 
2017. If it is not operationally feasible to use claims from this exact 
time period, we noted that we would use a 12-month period as close as 
practicable to September 1 of the calendar year 2 years preceding the 
performance period and August 31 of the calendar year preceding the 
performance period. This determination would allow clinicians to be 
made aware of their eligibility for facility-based measurement near the 
beginning of the MIPS performance period.
    We also recognized that in addition to the variation in the 
percentage of time a clinician is present in the hospital, there is 
also great variability in the types of services that clinicians 
perform. We considered whether certain clinicians should be identified 
as eligible for this facility-based measurement option based on 
characteristics in addition to their percentage of covered professional 
services furnished in the inpatient hospital or emergency room setting, 
such as by requiring a certain specialty such as hospital medicine or 
by limiting eligibility to those who served in patient-facing roles. 
However, we noted our belief that all MIPS eligible clinicians with a 
significant presence in the facility play a role in the overall 
performance of a facility, and therefore, did not propose to further 
limit this option based on characteristics other than the percentage of 
covered professional services furnished in an inpatient hospital or 
emergency room setting.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters supported our proposal that a MIPS 
eligible clinician is considered facility-based as an individual if the 
MIPS eligible clinician furnishes 75 percent or more of their covered 
professional services in sites of service identified by the POS codes 
used in the HIPAA standard transaction as an inpatient hospital, as 
identified by POS code 21, or an emergency room, as identified by POS 
code 23.
    Response: We appreciate the commenters' support. We are finalizing 
this policy as proposed, but as discussed below, we intend to continue 
analyzing refinements to facility-based eligibility for potential 
future rulemaking or to inform our interpretation of this final rule.
    Comment: Many commenters did not support our proposal that a MIPS 
eligible clinician is considered facility-based as an individual if the 
MIPS eligible clinician furnishes 75 percent or more of their covered 
professional services in sites of service identified by the POS codes 
used in the HIPAA standard transaction as an inpatient hospital, as 
identified by POS code 21, or an emergency room, as identified by POS 
code 23. Many of these commenters recommended that POS code 22, used 
for on-campus outpatient hospitals, be added to the POS codes used to 
determine applicability of facility-based measurement. They noted that 
this place of service code is used for providing observation services, 
which were indistinguishable from inpatient services because they are 
typically provided in the same physical space as inpatient services and 
on similar patients. They indicated that many clinicians that provide 
exclusively hospital services may not meet this definition due to the 
preponderance of observation services which they bill. Some commenters 
recommended that the facility-based definition be aligned with the 
hospital-based definition used in the advancing care information 
performance category, and therefore include POS code 19, which was 
proposed to be added for determination of hospital-based eligibility in 
addition to POS code 22 and the codes we did

[[Page 53757]]

propose for inclusion. These commenters noted that aligning definitions 
would simplify understanding of the program. A few commenters suggested 
the addition of POS codes 51 (inpatient psychiatric facility) and POS 
codes 52 (psychiatric facility partial hospital).
    Response: We remain concerned that including codes for outpatient 
hospital services could make eligible for facility-based measurement 
clinicians who have little or no contribution to a hospital's 
performance in the Hospital VBP Program. We recognize that observation 
services are similar to services provided in the inpatient hospital 
setting in many cases. However, there are many services, such as 
outpatient clinic visits, which include patients who may never visit 
the hospital in question as inpatients. We are finalizing our proposal 
for eligibility; however, we intend to further study the impact of 
including outpatient services on eligibility for facility-based 
clinicians and to determine if there is another method to distinguish 
observation services from other outpatient services. As noted above, we 
are finalizing our proposal, but with a delay in the implementation of 
facility-based measurement until the 2019 MIPS performance period/2021 
MIPS payment year. This will provide additional time for analysis and 
outreach to clinicians. We hope that this outreach will help to inform 
clinicians about the applicability of facility-based measurement. We 
will make future changes to the applicability of facility-based 
measurement in the context of that outreach and additional analysis. 
Any changes would be proposed in future rulemaking. We are specifically 
seeking comments on ways to identify clinicians who have a significant 
presence within the inpatient setting and address the concerns that we 
have noted above.
    Comment: Several commenters recommended that we adopt a threshold 
lower than 75 percent of services with particular place of service 
codes because some clinicians who work primarily or exclusively in a 
hospital might not meet our proposed definition. Some of these 
commenters recommended that clinicians be eligible if at least a 
majority of their services were provided with an eligible place of 
service code.
    Response: Because the 75 percent threshold is used in our 
determination of hospital-based eligible clinicians in the advancing 
care information performance category, we believe that a similar 
threshold would be appropriate to use in the determination of 
applicability of facility-based measurement. On an individual basis, 
all clinicians who quality for facility-based measurement would also 
qualify for hospital-based under the advancing care information 
category. If we were to adopt a lower threshold for facility-based 
measurement, this would no longer be the case. We believe that it is to 
the benefit of clinicians to know that even though the two definitions 
are not perfectly aligned, they have similar parameters and that 
qualifying for one (facility-based) would generally mean qualifying for 
the other (hospital-based). However, a clinician may qualify to be 
hospital-based but not qualify to be facility-based. If technically 
feasible, we will use 2018 as an opportunity to offer information to 
clinicians on their eligibility and applicability of facility-based 
measurement. While we are finalizing our proposal, we will continue to 
examine the 75 percent threshold to determine if this consistency is 
not necessary and will propose changes in future rulemaking if analysis 
suggests that this presents a significant barrier.
    Comment: A few commenters suggested that our proposal to determine 
facility-based measurement status not be limited to a review of place 
of service codes. One commenter suggested that we review the specialty 
of a clinician to determine if the clinician is a hospitalist. Another 
commenter suggested that facility-based measurement should be limited 
to clinicians for whom the Hospital VBP Program measures are related to 
their clinical area.
    Response: As we noted in the proposed rule, we considered whether 
to further limit facility-based measurement on characteristics such as 
specialty. However, we believe that there are clinicians other than 
those who are identified with the hospitalist specialty code who 
significantly contribute to the quality of care in the facility 
setting. We do not typically use a specialty code to determine special 
status in MIPS. In addition, the hospitalist specialty code was only 
established in 2017 so many clinicians who practice hospital medicine 
are not currently identified by that specialty code. We are unable to 
identify another way to identify a strong connection between a facility 
and a clinician at this time but will continue to analyze and welcome 
comments on this issue.
    Final Action: After consideration of the public comments, we are 
finalizing our proposals codified at Sec.  414.1380(e)(2) for the 
determination of eligibility for facility-based measurement as an 
individual. We note that facility-based measurement will not be 
available until the 2019 MIPS performance period/2021 MIPS payment year 
so clinicians will not be eligible until that time. We understand that 
there are concerns that some clinicians who practice primarily or 
exclusively in hospitals will not be eligible for facility-based 
measurement, particularly due to the complicating factor of observation 
services. We will use the next year to further examine this issue and 
determine if changes in eligibility should be proposed in future 
rulemaking. We are also finalizing technical and grammatical changes to 
the introductory text at paragraph (e)(2).
(iii) Facility-Based Measurement Group Participation
    We proposed at Sec.  414.1380(e)(2) that a MIPS eligible clinician 
is eligible for facility-based measurement under MIPS if they are 
determined facility-based as part of a group (82 FR 30126). We proposed 
at Sec.  414.1380(e)(2)(ii) that a facility-based group is a group in 
which 75 percent or more of the MIPS eligible clinician NPIs billing 
under the group's TIN are eligible for facility-based measurement as 
individuals as defined in Sec.  414.1380(e)(2)(i) (82 FR 30126). We 
also considered an alternative proposal in which a facility-based group 
would be a group where the TIN overall furnishes 75 percent or more of 
its covered professional services (as defined in section 1848(k)(3)(A) 
of the Act) in sites of service identified by the POS codes used in the 
HIPAA standard transaction as an inpatient hospital, as identified by 
POS code 21, or the emergency room, as identified by POS code 23, based 
on claims for a period prior to the performance period as specified by 
CMS (82 FR 30126). Groups would be determined to be facility-based 
through an evaluation of covered professional services between 
September 1 of the calendar year 2 years preceding the performance 
period through August 31 of the calendar year preceding the performance 
period with a 30 day claims run out period (or if not operationally 
feasible to use claims from this exact time period, a 12-month period 
as close as practicable to September 1 of the calendar year 2 years 
preceding the performance period and August 31 of the calendar year 
preceding the performance period).
    We requested comments on our proposal and alternative proposal.
    The following is a summary of the public comments received on the 
``Facility-Based Measurement Group Participation'' proposals and our 
responses:
    Comment: Several commenters recommended that groups be eligible for 
facility-based measurement if they meet

[[Page 53758]]

the requirements of either our proposal (75 percent or more of the MIPS 
eligible clinician NPIs billing under the group's TIN are eligible for 
facility-based measurement as individuals) or our alternative proposal 
(TIN overall furnishes 75 percent or more of its covered professional 
services in sites of service identified by the POS codes used to 
determine individual eligibility). These commenters noted that this 
would increase the number of groups eligible for this opportunity.
    Response: We understand the interest in providing multiple methods 
of eligibility but believe that establishing multiple methods increases 
complexity. In this case, we do not believe that the interests of 
flexibility outweigh those of simplicity, given that facility-based 
measurement will be available only for groups that are primarily 
composed of those who provide services in the hospital setting. We are 
finalizing our proposal that a facility-based group is one in which 75 
percent or more of the of the MIPS eligible clinician NPIs billing 
under the group's TIN are eligible for facility-based measurement as 
individuals. We are finalizing regulation text at Sec.  
414.1380(e)(2)(ii) to codify this standard for determining that a 
clinician group is a facility-based group and are making minor 
revisions to the regulatory text to match the proposed policy by 
explicitly referencing clinician NPIs billing under the group's TIN. In 
2018, we will provide more information to clinicians and groups on 
their eligibility for facility-based measurement and hope that sharing 
this information will help to provide more clarity. We will revisit 
this standard for identifying when a clinician group is a facility-
based group eligible for facility-based measurement in future 
rulemaking if changes are needed.
    Comment: A few commenters supported our alternative proposal in 
which a facility-based group would be a group where the TIN overall 
furnishes 75 percent or more of its covered professional services (as 
defined in section 1848(k)(3)(A) of the Act) in sites of service 
identified by the POS codes used to establish individual eligibility 
for facility-based measurement. These commenters expressed concern that 
CMS would be unable to properly identify all of the clinicians in the 
group and therefore unable to properly make this determination. One of 
the commenters suggested that it was easier to determine eligibility at 
the TIN level.
    Response: We agree that our proposed alternative approach of using 
all the claims submitted by a group is one way to calculate eligibility 
for facility-based measurement, but we also believe that our proposed 
approach would appropriately identify groups that should be eligible 
for facility-based measurement. We are able to identify through claims 
data all the individual NPIs that bill under a group TIN. In addition, 
we have several MIPS group status indicators that are determined by 75 
percent or more of the of the MIPS eligible clinician NPIs billing 
under the group's TIN meeting a certain designation. By finalizing our 
policy as proposed, we are aligning with those other group policies. 
For example, as discussed in section II.C.1.e. of this final rule with 
comment period, a group is determined to be non-patient facing 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 
discussed in section II.C.1.d. of this final rule with comment period, 
we use a similar threshold to determine which groups should have a 
rural or HPSA designation. However, as we perform outreach in 2018, we 
hope that we can clarify and address any concerns related to our 
ability to identify the clinicians that are associated with a 
particular practice and would be considered for facility-based 
measurement. If needed, we will revisit this policy through future 
rulemaking.
    Comment: One commenter recommended that groups of clinicians within 
a TIN be eligible as a facility-based group rather than requiring the 
entire group to be scored based on facility-based measurement.
    Response: Because of the scoring approach that we are adopting for 
facility-based measurement (discussed in section II.C.7.a.(4) of this 
final rule with comment period), a group is scored for the quality and 
cost performance category on the basis of facility-based measurement or 
through another method. We are unable to establish a group reporting 
mechanism that is not applicable for portions of a TIN. This score will 
be combined with scores on the improvement activity and advancing care 
information performance categories. Please refer to section II.C.3. of 
this final rule with comment period for additional information about 
reporting for groups.
    Comment: One commenter recommended that a group be eligible for 
facility-based measurement if more than 50 percent of the MIPS eligible 
clinicians met the requirements of facility-based measurement.
    Response: We believe that the 75 percent threshold better 
establishes that a group is primarily one that focuses on hospital 
care. It aligns with our proposal to identify non-patient facing groups 
and ensures that majority of clinicians in the group are involved in 
care that may be related to the measures in facility-based measurement. 
As we develop outreach in 2018, we aim to inform clinicians and groups 
about what their facility-based measurement eligibility would have been 
had we finalized these policies for application to the 2020 MIPS 
payment year; we hope this will clarify the application of this rule.
    Comment: One commenter recommended that there not be an option to 
establish a facility-based group, because, as proposed, a group could 
include many clinicians who do not practice in the facility setting.
    Response: We believe that the establishment of an opportunity for a 
group to be eligible for facility-based measurement is consistent with 
our general approach to group measurement in MIPS. A large group may 
include some clinicians who focus on the patients associated with 
submitted quality measures and others who focus on a different 
population. However, under group-based reporting in MIPS, all members 
of the group receive the same score. Facility-based measurement will 
only be available to those groups with a significant connection to the 
hospital (as measured by the settings of services for which claims are 
paid) and we believe only those groups that believe the hospital scores 
reflect their performance will elect the option. We believe that 
limiting the facility-based measurement to individuals would make the 
option less tenable and less consistent with our overall approach to 
MIPS, which is intended to provide flexibility to participate as a 
group or as an individual to the greatest extent possible. We also 
noted that facility-based measurement applies only to the quality and 
cost performance categories; groups and individuals must separately 
consider their participation in the advancing care information and 
improvement activities performance categories. We believe that groups 
will select the quality measures that they believe are most applicable 
to reflecting the overall quality of the group.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal for determining which groups are facility-based 
groups in regulation text at Sec.  414.1380(e)(2)(ii). We note that 
facility-based measurement will not be available until the 2019 MIPS 
performance period/2021 MIPS payment year so a facility-based group 
will not exist before that time. As

[[Page 53759]]

noted earlier, we are delaying the implementation of facility-based 
measurement until the 2019 MIPS performance period to ensure clinician 
understanding and operational readiness. We will propose any changes to 
this definition in future rulemaking.
(d) Facility Attribution for Facility-Based Measurement
    Many MIPS eligible clinicians provide services at more than one 
hospital, so we need a method to identify which hospital's scores 
should be associated with each MIPS eligible clinician that elects 
facility-based measurement under this option. We considered whether a 
clinician should be required to identify for us the hospital with which 
the clinician is affiliated, but believe that such a requirement would 
add unnecessary administrative burden in a process that we believe was 
intended to reduce burden. We also considered whether we could combine 
scores from multiple hospitals, but noted our belief that such a 
combination would reduce the alignment between a single hospital and a 
clinician or group and could be confusing for participants. We further 
noted that we believed we must establish a reasonable threshold for a 
MIPS eligible clinician's participation in clinical care at a given 
facility to allow that MIPS eligible clinician to be scored using that 
facility's measures. We noted that we do not believe it to be 
appropriate to allow MIPS eligible clinicians to claim credit for 
facilities' measures if the MIPS eligible clinician does not 
participate meaningfully in the care provided at the facility.
    Therefore, we proposed at Sec.  414.1380(e)(5) that MIPS eligible 
clinicians who elect facility-based measurement would receive scores 
derived from the value-based purchasing score (using the methodology 
described in section II.B.7.b.4. of the CY 2018 Quality Payment Program 
proposed rule (82 FR 30128 through 30129) for the facility at which 
they provided services for the most Medicare beneficiaries during the 
period of September 1 of the calendar year 2 years preceding the 
performance period through August 31 of the calendar year preceding the 
performance period with a 30-day claims run out (82 FR 30127). This 
period for identifying the facility whose performance will be 
attributed to a facility-based clinician (or group) is the same as the 
time period for services we will use to determine if a clinician (or 
group) is eligible for facility-based measurement; this time period 
also overlaps with parts of the performance period for the applicable 
Hospital VBP Program measures. We proposed that for the first year, the 
value-based purchasing score for the facility would be the FY 2019 
Hospital VBP Program's Total Performance Score. In cases in which there 
was an equal number of Medicare beneficiaries treated at more than one 
facility, we proposed to use the value-based purchasing score from the 
facility with the highest score (82 FR 30127).
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters supported our proposal that MIPS 
eligible clinicians that elect facility-based measurement would receive 
scores derived from the value-based purchasing score for the facility 
at which they provided services for the most Medicare beneficiaries 
during the period of September 1 of the calendar year 2 years preceding 
the performance period through August 31 of the calendar year.
    Response: We thank the commenters for their support.
    Comment: A few commenters opposed our proposed time period that 
would determine the facility that would determine the MIPS quality and 
cost score, noting that the clinician may have moved on to another 
facility by the time of the MIPS performance period. One commenter 
suggested that because of this issue that clinicians be given the 
opportunity to identify the hospital upon which their scores should be 
based.
    Response: We recognize that clinicians may move from one facility 
to another over time and a specific clinician may see a majority of his 
or her patients at one facility during 1 year but at a different 
facility in later years. However, our proposal to use the September 
through August period beginning 2 calendar years before the MIPS 
performance period begins for attribution of facility performance 
matched our proposed timeframe for claims used to determine whether a 
clinician (or group) is facility-based. This time period overlaps with 
parts of the performance period for the applicable Hospital VBP Program 
measures. If these timelines did not overlap, it would increase the 
likelihood that we determine a clinician met the requirements for 
facility- based measurement but did not have a hospital from which we 
could attribute performance. As noted in the proposed rule, we 
considered whether a clinician should be required to identify the 
hospital on which their scores should be based, but concluded that was 
more likely to be a burden on the clinician. We were also (and continue 
to be) concerned that permitting the clinician or group to choose could 
result in clinician or group selecting a hospital at which they did not 
provide care, either inadvertently due to selection error, or 
fraudulently.
    Comment: A few commenters noted that the proposed method of 
attributing clinicians to a facility did not identify a method that 
would determine attribution for a facility-based group. A few 
commenters suggested that in this situation that CMS use the score from 
the hospital attributed to an individual clinician in the group with 
the highest score on the Hospital VBP Program.
    Response: Although we did not specifically address the issue of how 
facility-based groups would be assigned to a facility (for purposes of 
attributing facility performance to the group) in the preamble of the 
CY 2018 Quality Payment Program proposed rule, our proposed regulation 
at Sec.  414.380(e)(5) did apply the same standard to individuals and 
groups. Although we believe that this provided sufficient notice of the 
policy, we will plan to address this issue as part of the next Quality 
Payment Program rulemaking cycle. We encourage all interested parties 
to review that proposal when it is issued and submit comments.
    Comment: A few commenters expressed concern that our proposed 
approach for facility attribution would not reflect the quality of care 
for clinicians that practice at multiple facilities. These commenters 
suggested that CMS consider future changes to the methodology to 
accommodate multiple facilities, such as using a weighted average of 
the facility scores.
    Response: We have designed the facility-based measurement option to 
align incentives between clinicians and facilities. Therefore, the 
intention is for a clinician or a group that spends significant time in 
a facility to be supporting the efforts to improve the score of that 
particular facility, particularly because we believe a desire to 
improve scores drives high quality care for patients. While we 
recognize that clinicians do practice in multiple facilities, we are 
concerned that developing a composite score based on the performance of 
multiple facilities would reduce that alignment by diffusing focus from 
a single facility and complicating scoring.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal for clinicians in facility-based measurement to 
receive scores derived from the value-based purchasing score for the 
facility at which they provided services for the

[[Page 53760]]

most Medicare beneficiaries during the period of September 1 of the 
calendar year 2 years preceding the performance period through August 
31 of the calendar year preceding the performance period with a 30-day 
claims run out. We are not finalizing regulation text associated with 
this specific policy (that is, identifying the period of the claims 
data used) as we consider implementation of this policy. We note that 
facility-based measurement will not be available until the 2019 MIPS 
performance period/2021 MIPS payment year so clinicians will not be 
assigned to a facility for attribution of the facility's performance 
before that time. We will address the issue of attribution for 
facility-based groups in future rulemaking.
(e) Election of Facility-Based Measurement
    We proposed at Sec.  414.1380(e)(3) that individual MIPS eligible 
clinicians or groups who wish to have their quality and cost 
performance category scores determined based on a facility's 
performance must elect to do so through an attestation. We proposed 
that those clinicians or groups who are eligible for and wish to elect 
facility-based measurement would be required to submit their election 
during the data submission period as determined at Sec.  414.1325(f) 
through the attestation submission mechanism established for the 
improvement activities and advancing care information performance 
categories. (82 FR 30127). We further proposed that, if technically 
feasible, we would let the MIPS eligible clinician know that they were 
eligible for facility-based measurement prior to the submission period, 
so that MIPS eligible clinicians would be informed if this option is 
available to them.
    We also considered an alternative approach of not requiring an 
election process but instead automatically applying facility-based 
measurement to MIPS eligible clinicians and groups who are eligible for 
facility-based measurement, if technically feasible. Under this 
approach, we would calculate a MIPS eligible clinician's facility-based 
measurement score based on the hospital's (as identified using the 
process described in section II.C.7.a.(4)(d) of the CY 2018 Quality 
Payment Program proposed rule (82 FR 30126 through 30127)) performance 
using the methodology described in section II.C.7.a.(4)(f) of the CY 
2018 Quality Payment Program proposed rule (82 FR 30128 through 30132), 
and automatically use that facility-based measurement score for the 
quality and cost performance category scores if the facility-based 
measurement score is higher than the quality and cost performance 
category scores as determined based on data submitted by the MIPS 
eligible clinician or group through any available reporting mechanism. 
This facility-measurement score would be calculated even if an 
individual MIPS eligible clinician or group did not submit any data for 
the quality performance category. We explained how this alternative 
approach might work in the CY 2018 Quality Payment Program proposed 
rule in connection with choosing the time period of the hospital 
performance in the Hospital VBP Program (82 FR 30127). We noted our 
concern that a method that does not require active selection may result 
in MIPS eligible clinicians being scored on measures at a facility and 
being unaware that such scoring is taking place. We also expressed 
concern that such a method could provide an advantage to those 
facility-based clinicians who do not submit quality measures in 
comparison to those who work in other environments. We also noted that 
this option may not be technically feasible for us to implement for the 
2018 MIPS performance period.
    We invited comments on this proposal and alternate proposal.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters supported our proposal to require 
clinicians or groups to opt-in through a voluntary election process in 
order to participate in facility-based measurement. These commenters 
noted that clinicians should be given the opportunity to determine if 
the quality of a hospital reflected the quality of the clinician or if 
they would be better represented using a different submission 
mechanism.
    Response: We appreciate the support of the commenters. As noted 
below, we are not finalizing the attestation mechanism aspect of our 
proposal or our alternative, but we will revisit through future 
rulemaking how to permit an individual clinician or group to elect 
facility-based measurement.
    Comment: A few commenters supported our alternative approach of not 
requiring an election process but instead automatically applying 
facility-based measurement to MIPS eligible clinicians and groups who 
are eligible for facility-based measurement unless they opt out. These 
commenters noted that this would reduce administrative burden and some 
clinicians who would be eligible would fail to opt in.
    Response: We appreciate the interest in minimizing administrative 
burden for clinicians. We will aim to minimize administrative burden on 
clinicians and groups for whichever method would be used for 
determination of facility-based measurement.
    Comment: A few commenters expressed concern about the details of 
the opt-in process. One commenter expressed concern that an 
administrator would be unable to opt in on behalf of clinicians in a 
group. One commenter recommended that third party intermediaries be 
able to receive information on facility-based measurement through an 
API framework.
    Response: As described further above, we are not implementing 
facility-based measurement until the 2019 MIPS performance period. We 
will use the additional year to better explain to clinicians how the 
facility-based measurement will work under the regulatory provisions we 
are finalizing at Sec.  414.1380(e), including the determination of 
when a clinician or group is facility-based and thus able to elect to 
use facility measurement, the time period for making that 
determination, and the use of the facility's Hospital VBP Program 
performance to score the clinician or group.
    Final Action: After consideration of the public comments, we are 
not finalizing either our proposal or our alternative option for how an 
individual clinician or group will elect to use and be identified as 
using facility-based measurement for the MIPS program. Because we are 
not offering facility-based measurement until the 2019 MIPS performance 
period, we do not need to finalize either of these for the 2018 MIPS 
performance period. We will use the additional time to examine the 
attestation process we proposed and the alternative opt-out process. We 
intend to work with stakeholders to identify a procedure that best 
balances administrative burden and clinician choice for proposal in 
next year's proposed rule. We are not finalizing our proposed 
regulatory text at Sec.  414.1380(e)(3), but will reserve that section 
for our future proposals.
    In light of our interest in reducing burden, we do prefer an option 
that would not require a clinician or practice to notify CMS through 
attestation or other method. We therefore seek comment on whether a 
process by which a clinician or group would be automatically assigned a 
score under facility-based measurement but be notified and given the 
opportunity to

[[Page 53761]]

opt out of facility-based measurement would be appropriate.
(f) Facility-Based Measures
    For FY 2019, the Hospital VBP Program has adopted 12 quality and 
efficiency measures. The Hospital VBP Program currently includes 4 
domains: Person and community engagement, clinical care, safety, and 
efficiency and cost reduction. These domains align with many MIPS high 
priority measures (outcome, appropriate use, patient safety, 
efficiency, patient experience, and care coordination measures) in the 
quality performance category and the efficiency and cost reduction 
domain closely aligns with our cost performance category. We believe 
this set of measures covering 4 domains and composed primarily of 
measures that would be considered high priority under the MIPS quality 
performance category capture a broad picture of hospital-based care. 
Additionally, the Hospital VBP Program has adopted several measures of 
clinical outcomes in the form of 30-day mortality measures, and 
clinical outcomes are a high-priority topic for MIPS. The Hospital VBP 
Program includes several measures in a safety domain, which meets our 
definition of patient safety measures as high-priority. Therefore, we 
proposed that facility-based individual MIPS eligible clinicians or 
groups that are attributed to a hospital would be scored on all the 
measures on which the hospital is scored for the Hospital VBP Program 
via the Hospital VBP Program's Total Performance Score scoring 
methodology (82 FR 30127).
    The Hospital VBP Program's FY 2019 measures, and their associated 
performance periods, were reproduced in Table 33 in the proposed rule 
(82 FR 30128). Here, we are including, in Table 26, a list of the 
finalized FY2019 Hospital VBP Program Measures.

                                 Table 26--FY 2019 Hospital VBP Program Measures
----------------------------------------------------------------------------------------------------------------
            Short name                Domain/measure name     NQF No.              Performance period
----------------------------------------------------------------------------------------------------------------
                                     Person and Community Engagement Domain
----------------------------------------------------------------------------------------------------------------
HCAHPS...........................  Hospital Consumer              0166  CY 2017.
                                    Assessment of               (0228)
                                    Healthcare Providers
                                    and Systems (HCAHPS)
                                    (including Care
                                    Transition Measure).
----------------------------------------------------------------------------------------------------------------
                                              Clinical Care Domain
----------------------------------------------------------------------------------------------------------------
MORT-30-AMI......................  Hospital 30-Day, All-          0230  July 1, 2014-June 30, 2017.
                                    Cause, Risk-
                                    Standardized Mortality
                                    Rate (RSMR) Following
                                    Acute Myocardial
                                    Infarction (AMI)
                                    Hospitalization.
MORT-30-HF.......................  Hospital 30-Day, All-          0229  July 1, 2014-June 30, 2017.
                                    Cause, Risk-
                                    Standardized Mortality
                                    Rate (RSMR) Following
                                    Heart Failure (HF)
                                    Hospitalization.
MORT-30-PN.......................  Hospital 30-Day, All-          0468  July 1, 2014-June 30, 2017.
                                    Cause, Risk-
                                    Standardized Mortality
                                    Rate (RSMR) Following
                                    Pneumonia
                                    Hospitalization.
THA/TKA..........................  Hospital-Level Risk-           1550  January 1, 2015-June 30, 2017.
                                    Standardized
                                    Complication Rate
                                    (RSCR) Following
                                    Elective Primary Total
                                    Hip Arthroplasty (THA)
                                    and/or Total Knee
                                    Arthroplasty (TKA).
----------------------------------------------------------------------------------------------------------------
                                                  Safety Domain
----------------------------------------------------------------------------------------------------------------
CAUTI............................  National Healthcare            0138  CY 2017.
                                    Safety Network (NHSN)
                                    Catheter-Associated
                                    Urinary Tract Infection
                                    (CAUTI) Outcome Measure.
CLABSI...........................  National Healthcare            0139  CY 2017.
                                    Safety Network (NHSN)
                                    Central Line-Associated
                                    Bloodstream Infection
                                    (CLABSI) Outcome
                                    Measure.
Colon and Abdominal Hysterectomy   American College of            0753  CY 2017.
 SSI.                               Surgeons--Centers for
                                    Disease Control and
                                    Prevention (ACS-CDC)
                                    Harmonized Procedure
                                    Specific Surgical Site
                                    Infection (SSI) Outcome
                                    Measure.
MRSA Bacteremia..................  National Healthcare            1716  CY 2017.
                                    Safety Network (NHSN)
                                    Facility-wide Inpatient
                                    Hospital-onset
                                    Methicillin-resistant
                                    Staphylococcus aureus
                                    (MRSA) Bacteremia
                                    Outcome Measure.
CDI..............................  National Healthcare            1717  CY 2017.
                                    Safety Network (NHSN)
                                    Facility-wide Inpatient
                                    Hospital-onset
                                    Clostridium difficile
                                    Infection (CDI) Outcome
                                    Measure.
PC-01............................  Elective Delivery.......       0469  CY 2017.
----------------------------------------------------------------------------------------------------------------
                                      Efficiency and Cost Reduction Domain
----------------------------------------------------------------------------------------------------------------
MSPB.............................  Payment-Standardized           2158  CY 2017.
                                    Medicare Spending Per
                                    Beneficiary (MSPB).
----------------------------------------------------------------------------------------------------------------

    We noted that the Patient Safety Composite Measure (PSI-90) was 
proposed for removal beginning with the FY 2019 measure set in the FY 
2018 Hospital Inpatient Prospective Payment Systems for Acute Care 
Hospitals and the Long Term Care Hospital Prospective Payment System 
(IPPS/LTCH PPS) proposed rule (82 FR 19970) due to issues with 
calculating the measure score and that we would remove the measure from 
the list of those adopted for facility-based measurement in the MIPS 
program if that proposal was finalized. The proposal to remove the PSI-
90 measure was finalized in the FY 2018 IPPS/LTCH PPS final rule (82 FR 
38244).
    We proposed at Sec.  414.1380(e)(4) that there are no data 
submission requirements for the facility-based measures used to assess 
performance in the quality and cost performance categories, other than 
electing the option through attestation as proposed in the CY 2018 
Quality Payment Program proposed rule (82 FR 30128).
    The following is a summary of the public comments received on the 
``Facility-Based Measures'' proposals and our responses:
    Comment: Several commenters supported our proposal to adopt all 
measures and performances from the FY 2019 Hospital VBP Program for the 
purposes of facility-based measurement

[[Page 53762]]

in the MIPS program for the 2018 MIPS performance period/2020 MIPS 
payment year because those measures represented the total performance 
of the hospital and were well known by clinicians.
    Response: We thank the commenters for their support. Because we are 
delaying the implementation of facility-based measure until the 2019 
MIPS performance period, these measures will not be available for the 
2018 MIPS performance period. We intend to propose in next year's 
rulemaking the facility measures that will be used for purpose of the 
2019 MIPS performance period.
    Comment: Several commenters recommended that clinicians be able to 
select measures from the Hospital VBP Program and the Hospital 
Inpatient Quality Reporting (IQR) Program in order to better identify 
those that they noted were relevant to their practice. These commenters 
indicated that using all measures from the Hospital VBP Program was not 
necessarily representative of the individual clinician's quality.
    Response: We have a policy goal to align incentives between 
clinicians and facilities through facility-based measurement. We 
believe that any efforts to measure clinicians on a subset of measures 
rather than the entire measure set reduces that alignment. In addition, 
we believe that a measure selection process would introduce unnecessary 
administrative burden. If clinicians do not believe that the measures 
that are included for that facility measurement program are 
appropriate, there are opportunities to participate in MIPS that offer 
more flexibility in measure selection other than the use of facility-
based measurement.
    Comment: A few commenters recommended that instead of using 
measures that are part of the Hospital VBP Program or other pay-for-
reporting or pay-for-performance program, that we use measures from 
registries or other sources. These measures might reflect the 
performance of an entire facility but would be more closely tied to the 
activities of a particular clinician.
    Response: Section 1848(q)(2)(C)(ii) of the Act provides that the 
Secretary may use measures used for payment systems other than for 
physicians, such as measures for inpatient hospitals, for purposes of 
the quality and cost performance categories. Based on this statutory 
requirement and because we want to align incentives between clinicians 
and hospitals, we have elected to use measures that are developed and 
implemented into other programs, as opposed to other new measures that 
reflect a facility's performance. We note that there may be 
opportunities for clinicians to participate in MIPS using qualified 
registries or QCDRs that measure quality for services that may be 
provided in a facility setting, without being measured in facility-
based measurement.
    Comment: Several commenters expressed concern that the performance 
periods for the measures that we proposed for inclusion for facility-
based measurement did not align with the performance period used for 
other measures and requested that the performance periods be aligned.
    Response: We recognize that the performance periods adopted for the 
measures under the Hospital VBP Program differ from the performance 
period for MIPS measures. As we have discussed with respect to the 
Hospital VBP Program (such as in the FY 2013 IPPS/LTCH PPS final rule, 
77 FR 53594), we take several considerations into account when adopting 
performance periods for the Hospital VBP Program, including previously-
adopted performance periods under the Hospital VBP Program, the 
possible duration of the performance period, and the reliability of the 
data that we collect. We also consider the statutory requirement that 
hospitals be notified of their Total Performance Scores and payment 
adjustments no later than 60 days prior to the fiscal year involved, as 
well as the time necessary for quality measures submission and Total 
Performance Score computations.
    When developing our facility-based measurement policy under MIPS, 
we also took into account our beliefs that aligning incentives and 
informing clinicians about their opportunity to participate in MIPS 
outweighs the interest in aligning the performance period between the 
Hospital VBP Program and MIPS. We believe that we must encourage 
participation in MIPS, and we view the facility-based measurement 
option as one policy that enables us to so encourage participating 
clinicians. We will consider ways to align performance periods between 
the Hospital VBP Program and the Quality Payment Program in the future.
    Comment: A few commenters opposed the inclusion of the PSI-90 
measure as a measure to be used for facility-based measurement. Others 
expressed concern about the inclusion of measures that are part of 
future years of the Hospital VBP Program, such as condition-specific 
episode-based payment measures.
    Response: In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38244), we 
finalized our proposal to remove the PSI-90 measure from the FY 2019 
Hospital VBP Program measure set. We noted in the proposed rule that if 
this measure was to be removed from that measure set, we would also 
remove it from the measures set used for facility-based measurement. We 
will consider issues of measures included in future years of other 
programs in future rulemaking for the Quality Payment Program.
    Comment: Several commenters opposed the inclusion of the MSPB 
measure from the FY 2019 Hospital VBP Program as a measure for 
facility-based measurement. These commenters noted that we had also 
proposed to weight the cost performance category at zero percent, so 
clinicians in facility-based measurement would be disadvantaged by 
including this similar measure.
    Response: As noted earlier in this section, we will not offer the 
opportunity to participate in facility-based measurement for the 2020 
MIPS payment year. When facility-based measurement is offered beginning 
with the 2021 MIPS payment year, the cost performance category will be 
equally weighted to the quality performance category. The MSPB measure 
is part of the overall Hospital VBP Program score and reflects an 
important measure of the overall value of care in that environment. Our 
scoring methodology is intended to translate the overall score of value 
in the Hospital VBP Program to a measure of value in the MIPS quality 
and cost performance categories. Section II.C.7.a.(4)(g) of this final 
rule with comment period discusses the scoring for facility-based 
measurement.
    Final Action: After consideration of the public comments, we are 
not finalizing our proposal that the facility-based measures available 
for the 2018 MIPS performance period are the measures adopted for the 
FY 2019 Hospital VBP Program. We are also not finalizing our proposal 
that for the 2020 MIPS payment year facility-based individual MIPS 
eligible clinicians or groups that are attributed to a hospital would 
be scored on all the measures on which the hospital is scored for the 
Hospital VBP Program via the Hospital VBP Program's Total Performance 
Score methodology. (As discussed in section II.C.7.a.(4)(g) of this 
final rule with comment period, we are finalizing a facility-based 
measurement scoring standard, but not the specific instance of using FY 
2019 Hospital VBP Program Total Performance Score methodology.)
    We believe that the policy approach of using all measures from a 
value-based purchasing program is appropriate. However, we are not 
adopting these

[[Page 53763]]

proposals because we are not implementing facility-based measurement 
for the 2018 MIPS performance period/2020 MIPS payment year and as such 
cannot finalize any measures or scoring under this program for that 
performance period and payment year for the purpose of facility-based 
measurement in MIPS. We intend to propose measures that would be 
available for facility-based measurement for the 2019 MIPS performance 
period/2021 MIPS payment year in future rulemaking. As noted in section 
II.C.7.a.(4)(a) of this final rule with comment period, we are adopting 
at Sec.  414.1380(e)(6)(i) that quality and cost measures for which 
facility-based measurement will be available are those adopted under 
the value-based purchasing program of the facility for the year 
specified and at Sec.  414.1380(e)(6)(iii) that the performance period 
for facility-based measurement is the performance period for the 
measures adopted under the value-based purchasing program of the 
facility program for the year specified. These provisions refer to the 
general parameters of our method of facility-based measurement. 
Specific programs and years would be addressed in future rulemaking.
    We are finalizing our proposal at Sec.  414.1380(e)(4) with 
modification to state that there are no data submission requirements 
for clinicians for the facility-based measures used to assess 
performance in the quality and cost performance categories. Because we 
have not finalized a method of electing facility-based measurement in 
Sec.  414.1380(e)(3), we are deleting the phrase ``other than electing 
the option through attestation as described in paragraph (e)(3) of this 
section''. In addition, we are revising the text to clarify that the 
lack of data submission requirements is for individual clinicians and 
groups of clinicians, rather than a statement about the submission by 
facilities for the facility performance program.
(g) Scoring Facility-Based Measurement
(i) Hospital VBP Program Scoring
    We believe that the Hospital VBP Program represents the most 
appropriate value-based purchasing program with which to begin 
implementation of the facility-based measurement option under MIPS. We 
offered a summary of the Hospital VBP Program scoring and compared it 
to MIPS scoring in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30128 through 30129).
(ii) Applying Hospital VBP Program Scoring to the MIPS Quality and Cost 
Performance Categories
    We summarized in the proposed rule (82 FR 30129) what we considered 
prior to proposing at Sec.  414.1380(e) that facility-based scoring be 
available for cost and quality performance categories. We considered 
several methods to incorporate facility-based measures into scoring for 
the 2020 MIPS payment year, including selecting hospitals' measure 
scores, domain scores, and the Hospital VBP Program Total Performance 
Scores to form the basis for the cost and quality performance category 
scores for individual MIPS eligible clinicians and groups that are 
eligible to participate in facility-based measurement. We proposed the 
option that we believed provided the fairest comparison between 
performance in the 2 programs and would best allow us to expand the 
opportunity to other programs in the future.
    Unlike MIPS, the Hospital VBP Program does not have performance 
categories. There are instead four domains of measures. We considered 
whether we should try to identify certain domains or measures that were 
more closely aligned with those identified in the quality performance 
category or the cost performance category. We also considered whether 
we should limit the application of facility-based measurement to the 
quality performance category and calculate the cost performance 
category score as we do for other clinicians. However, we believe that 
value-based purchasing programs are generally constructed to assess an 
overall picture of the care provided by the facility, taking into 
account both the costs and the quality of care provided. Given our 
focus on alignment between quality and cost, we also do not believe it 
is appropriate to measure quality on one unit (a hospital) and cost on 
another (such as an individual clinician or TIN). Therefore, we 
proposed at Sec.  414.1380(e) that facility-based scoring is available 
for the quality and cost performance categories and that the facility-
based measurement scoring standard is the MIPS scoring methodology 
applicable for those who meet facility-based eligibility requirements 
and who elect facility-based measurement.
    The following is a summary of the public comments received on 
``Applying Hospital VBP Program Scoring to the MIPS Quality and Cost 
Performance Categories'' proposals and our responses:
    Comment: Several commenters supported our proposed methodology of 
applying Hospital VBP Program scoring to the MIPS quality and cost 
performance categories.
    Response: We thank the commenters for their support.
    Final Action: After consideration of the public comments, we are 
finalizing our proposed methodology applying Hospital VBP Program 
scoring to MIPS quality and cost performance categories with 
modifications. As noted, we are delaying the implementation of 
facility-based measurement by 1 year in order to increase clinician 
understanding and operational readiness to offer the program. As such, 
we are finalizing the introductory regulation text at Sec.  
414.1380(e)(1) (that the facility-based measurement scoring standard is 
the MIPS scoring methodology applicable for MIPS eligible clinicians 
identified as meeting the requirements in paragraph (e)(2) and (3) of 
this section) but are not finalizing the text proposed for paragraphs 
(e)(1)(A) and (B) that would specifically identify use of the FY 2019 
Hospital VBP Program for this purpose. We will address this issue in 
future rulemaking to identify the specifics of the Hospital VBP Program 
performance and scoring to be used for facility-based measurement in 
MIPS.
(iii) Benchmarking Facility-Based Measures
    Measures in the MIPS quality performance category are benchmarked 
to historical performance on the basis of performance during the 12-
month calendar year that is 2 years prior to the performance period for 
the MIPS payment year. If a historical benchmark cannot be established, 
a benchmark is calculated during the performance period. In the cost 
performance category, benchmarks are established during the performance 
period because changes in payment policies year to year can make it 
challenging to compare performance on cost measure year to year. 
Although we proposed a different performance period for MIPS eligible 
clinicians in facility-based measurement, the baseline period used for 
creating MIPS benchmarks is generally consistent with this approach. We 
noted that the Hospital VBP Program uses measures for the same fiscal 
year even if those measures do not have the same performance period 
length, but the baseline period closes well before the performance 
period. The MSPB is benchmarked in a manner that is similar to measures 
in the MIPS cost performance category. The MSPB only uses a historical 
baseline period for improvement scoring and bases its achievement 
threshold and benchmark solely on the performance period (81 FR

[[Page 53764]]

57002). We proposed at Sec.  414.1380(e)(6)(ii) that the benchmarks for 
facility-based measurement are those that are adopted under the value-
based purchasing program of the facility for the year specified (82 FR 
30130).
    Final Action: We did not receive any comments specifically on the 
``Benchmarking Facility-Based Measures'' proposals, and we are 
finalizing the policy as proposed in Sec.  414.1380(e)(6)(ii). While we 
are not making facility-based measurement available until the 2019 MIPS 
performance period/2021 MIPS payment year (and are therefore not 
finalizing use of the FY 2019 Hospital VBP Program measurement), we are 
finalizing that benchmarks are those adopted under the value-based 
purchasing program of the facility program for the year specified. We 
will identify the particular value-based purchasing program in future 
rulemaking but would routinely use the benchmarks associated with that 
program.
(iv) Assigning MIPS Performance Category Scores Based on Hospital VBP 
Performance
    Performance measurement in the Hospital VBP Program and MIPS is 
quite different in part due to the design and the maturity of the 
programs. The Hospital VBP Program only assigns achievement points to a 
hospital for its performance on a measure if the hospital's performance 
during the performance period meets or exceeds the median of hospital 
performance on that measure during the applicable baseline period (or 
in the case of the MSPB measure, if the hospital's performance during 
the performance period meets or exceeds the median of hospital 
performance during that period), whereas MIPS assigns achievement 
points to all measures that meet the required data completeness and 
case minimums. In addition, the Hospital VBP Program has removed many 
process measures and topped out measures since its first program year 
(FY 2013), while both process and topped out measures are available in 
MIPS. With respect to the FY 2017 program year, for example, the median 
Total Performance Score for a hospital in Hospital VBP Program was 
33.88 out of 100 possible points. If we were to simply assign the 
Hospital VBP Program Total Performance Score for a hospital to a 
clinician, the performance of those MIPS eligible clinicians electing 
facility-based measurement would likely be lower than most who 
participated in the MIPS program, particularly in the quality 
performance category.
    We noted that we believe that we should recognize relative 
performance in the facility programs that reflect their different 
designs. Therefore, we proposed at Sec.  414.1380(e)(6)(iv) that the 
quality performance category score for facility-based measurement is 
reached by determining the percentile performance of the facility 
determined in the value-based purchasing program for the specified year 
as described under Sec.  414.1380(e)(5) and awarding a score associated 
with that same percentile performance in the MIPS quality performance 
category score for those clinicians who are not scored using facility-
based measurement (82 FR 30130). We also proposed at Sec.  
414.1380(e)(6)(v) that the cost performance category score for 
facility-based measurement is established by determining the percentile 
performance of the facility determined in the value-based purchasing 
program for the specified year as described in Sec.  414.1380(e)(5) and 
awarding the number of points associated with that same percentile 
performance in the MIPS cost performance category score for those 
clinicians who are not scored using facility-based measurement (82 FR 
30130). (In the context of our proposal, this year would have been the 
FY 2019 year for the Hospital VBP program, as we proposed in section 
II.C.7.a.(4)(e) to use that as the attributed performance for MIPS 
eligible clinicians and groups that elected facility-based 
measurement.) For example, if the median Hospital VBP Program Total 
Performance Score was 35 out of 100 possible points and the median 
quality performance category percent score in MIPS was 75 percent and 
the median cost performance category score was 50 percent, then a 
clinician or group that is evaluated based on a hospital that received 
an Hospital VBP Program Total Performance Score of 35 points would 
receive a score of 75 percent for the quality performance category and 
50 percent for the cost performance category. The percentile 
distribution for both the Hospital VBP Program and MIPS would be based 
on the distribution during the applicable performance periods for each 
of the programs and not on a previous benchmark year.
    We noted in the proposed rule our belief that the proposal offers a 
fairer comparison of the performance among participants in MIPS and the 
Hospital VBP Program compared to other options we considered and 
provides an objective means to normalize differences in measured 
performance between the programs. In addition, we noted that this 
method will make it simpler to apply the concept of facility-based 
measurement to additional programs in the future.
    The following is a summary of the public comments received on the 
``Assigning MIPS Performance Category Scores based on Hospital VBP 
Performance'' proposals and our responses:
    Comment: Several commenters supported our proposed approach to 
translate performance in the Hospital VBP Program into MIPS quality and 
cost performance category scores using a percentile distribution.
    Response: We thank the commenters for their support.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to determine the percentile performance of the 
facility determined for the specified year and awarding a score 
associated with that same percentile performance in the MIPS quality 
performance category score and MIPS cost performance category score for 
those clinicians who are not scored using facility-based measurement, 
but are not finalizing use of the FY 2019 Hospital VBP Program 
measurement and scoring. We are modifying the regulatory text at Sec.  
414.1380(e) to clarify that this determination will be based on the 
year the claims are drawn from in Sec.  414.1380(e)(2). We note that 
facility-based measurement will not be available until the 2019 MIPS 
performance period/2021 MIPS payment year so clinicians will not be 
scored through facility-based measurement until that time.
(v) Scoring Improvement for Facility-Based Measurement
    The Hospital VBP Program includes a methodology for recognizing 
improvement on individual measures which is then incorporated into the 
total performance score for each participating hospital. A hospital's 
performance on a measure is compared to a national benchmark, as well 
as its own performance from a corresponding baseline period.
    We proposed to consider improvement in the quality and cost 
performance categories. In the CY 2018 Quality Payment Program proposed 
rule (82 FR 30113), we proposed to measure improvement in the quality 
performance category based on improved achievement for the performance 
category percent score and award improvement even if, under certain 
circumstances, a clinician moves from one identifier to another from 1 
year to the next. For those who may be measured under facility-based

[[Page 53765]]

measurement, improvement is already captured in the scoring method used 
by the Hospital VBP Program, so we do not believe it is appropriate to 
separately measure improvement using the proposed MIPS methodology for 
clinicians and groups that elect facility-based measurement. Although 
the improvement methodology is not identical in the Hospital VBP 
Program compared to our MIPS proposal, improvement is reflected in the 
underlying Hospital VBP Program measurement because a hospital that 
demonstrated improvement in the individual measures would in turn 
receive points under the Hospital VBP Program methodology if the 
improvement score is higher than their achievement score. In addition, 
improvement is already captured in the distribution of MIPS performance 
scores that is used to translate Hospital VBP Program Total Performance 
Score into a MIPS quality performance category score. Therefore, we did 
not propose any additional improvement scoring for facility-based 
measurement for either the quality or cost performance category.
    Because we indicated our intention to allow clinicians the 
flexibility to elect facility-based measurement on an annual basis, we 
noted that some clinicians may be measured through facility-based 
measurement in 1 year and through another MIPS method in the next. We 
sought comment on how to assess improvement for those that switch from 
facility-based scoring to another MIPS method in a later year. We 
requested comment on whether it is appropriate to include measurement 
of improvement in the MIPS quality performance category for MIPS 
eligible clinicians and groups that use facility-based measures given 
that the Hospital VBP Program already takes improvement into account in 
its scoring methodology (82 FR 30130).
    In the CY 2018 Quality Payment Program proposed rule, we discussed 
our proposal to measure improvement in the cost performance category at 
the measure level (82 FR 30121). We proposed that clinicians under 
facility-based measurement would not be eligible for a cost improvement 
score in the cost performance category (82 FR 30130). As in the quality 
performance category, we believe that a clinician participating in 
facility-based measurement in subsequent years would already have 
improvement recognized as part of the Hospital VBP Program methodology 
and therefore, should not be given additional credit. In addition, 
because we proposed to limit measurement of improvement to those MIPS 
eligible clinicians that participate in MIPS using the same identifier 
and are scored on the same cost measure(s) in 2 consecutive performance 
periods, those MIPS eligible clinicians who elect facility-based 
measurement would not be eligible for a cost improvement score in the 
cost performance category under the proposed methodology because they 
would not be scored on the same cost measure(s) for 2 consecutive 
performance periods.
    The following is a summary of the public comments received on the 
``Scoring Improvement for Facility-Based Measurement'' proposals and 
our responses:
    Comment: One commenter supported our proposal to not assess 
improvement for participants in facility-based measurement.
    Response: We appreciate the support of the commenter.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal that a clinician or group participating in 
facility-based measurement would not be given the opportunity to earn 
improvement points based on prior performance in the MIPS quality and 
cost performance categories. We did not propose and are not finalizing 
regulation text on this aspect of facility-based measurement because we 
believe it is unnecessary.
(vi) Bonus Points for Facility-Based Measurement
    MIPS eligible clinicians that report on quality measures are 
eligible for bonus points for the reporting of additional outcome and 
high priority measures beyond the one that is required. Two bonus 
points are awarded for each additional outcome or patient experience 
measure, and one bonus point is awarded for each additional other high 
priority measure. These bonus points are intended to encourage the use 
of measures that are more impactful on patients and better reflect the 
overall goals of the MIPS program. Many of the measures in the Hospital 
VBP Program meet the criteria that we have adopted for high-priority 
measures. We support measurement that takes clinicians' focus away from 
clinical process measures; however, the proposed scoring method 
described above is based on a percentile distribution of scores within 
the quality and cost performance categories that already accounts for 
bonus points. For this reason, we did not propose to calculate 
additional high priority bonus points for facility-based measurement.
    We noted that clinicians have an additional opportunity to receive 
bonus points in the quality performance category score for using end-
to-end electronic submission of quality measures. The Hospital VBP 
Program does not capture whether or not measures are reported using 
end-to-end electronic reporting; however, our proposed facility-based 
scoring method described above is based on a percentile distribution of 
scores within the quality and cost performance categories. Because the 
MIPS quality performance category scores already account for bonus 
points, including end-to-end electronic reporting, when we translate 
the Total Performance Score, the overall effect of end-to-end 
electronic reporting would be captured in the translated score. For 
this reason, we did not propose to calculate additional end-to-end 
electronic reporting bonus points for facility-based measurement.
    The following is a summary of the public comments received on the 
``Bonus Points for Facility-Based Measurement'' proposals and our 
responses:
    Comment: A few commenters supported our proposal to not calculate 
bonus points for additional high priority or end-to-end electronic 
reporting of measures.
    Response: We thank the commenters for their support of the 
proposal.
    Comment: A few commenters opposed our proposal to not calculate 
bonus points for additional high priority measures or end-to-end 
electronic reporting. One of the commenters noted the similarity of 
facility-based measurement to the CMS Web Interface because there was 
no opportunity to select measures in either method, and noted that 
those who submitted via web interface did receive bonus points for both 
additional high priority measures and end-to-end electronic reporting.
    Response: Because our scoring approach to facility-based 
measurement is based on a translation of the facility's performance 
under the Hospital VBP Program scoring methodology to the MIPS quality 
and cost performance categories, we do not believe it is appropriate to 
add bonus points based on measure selection. The CMS Web Interface 
method is scored in a manner that determines performance on individual 
measures and is scored in the same way as other MIPS submission 
mechanisms with a few exceptions.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to not award bonus points for additional high 
priority and end-to-end electronic reporting for clinicians scored 
under facility-based measurement. We did not propose and are not 
finalizing regulation text on this

[[Page 53766]]

aspect of facility-based measurement because we believe it is 
unnecessary.
(vii) Special Rules for Facility-Based Measurement
    Some hospitals do not receive a Total Performance Score in a given 
year in the Hospital VBP Program, whether due to insufficient quality 
measure data, failure to meet requirements under the Hospital IQR 
Program, or other reasons. In these cases, we would be unable to 
calculate a facility-based score based on the hospital's performance, 
and facility-based clinicians would be required to participate in MIPS 
via another method. Most hospitals which do not receive a Total 
Performance Score in the Hospital VBP Program are routinely excluded, 
such as hospitals in Maryland. In such cases, facility-based clinicians 
would know well in advance that the hospital would not receive a Total 
Performance Score, and that they would need to participate in MIPS 
through another method. However, we noted that we are concerned that 
some facility-based clinicians may provide services in hospitals which 
they expect will receive a Total Performance Score but do not due to 
various rare circumstances such as natural disasters. In the CY 2018 
Quality Payment Program proposed rule (82 FR 30142 through 30143) we 
proposed a process for requesting a reweighting assessment for the 
quality, cost and improvement activities performance categories due to 
extreme and uncontrollable circumstances, such as natural disasters. We 
proposed that MIPS eligible clinicians who are facility-based and 
affected by extreme and uncontrollable circumstances, such as natural 
disasters, may apply for reweighting (82 FR 30131).
    In addition, we noted that hospitals may submit correction requests 
to their Total Performance Scores calculated under the Hospital VBP 
Program, and may also appeal the calculations of their Total 
Performance Scores, subject to Hospital VBP Program requirements 
established in prior rulemaking. Our proposal was to use the final 
Hospital VBP Program Total Performance Score for the facility-based 
measurement option under MIPS. In the event that a hospital obtains a 
successful correction or appeal of its Total Performance Score, we 
would update MIPS eligible clinicians' quality and cost performance 
category scores accordingly, as long as the update could be made prior 
to the application of the MIPS payment adjustment for the relevant MIPS 
payment year.
    Additionally, although we wish to tie the hospital and clinician 
performance as closely together as possible for purposes of the 
facility-based scoring policy, we do not wish to disadvantage those 
clinicians and groups that select this measurement method. In the CY 
2018 Quality Payment Program proposed rule, we proposed to retain a 
policy equivalent to the 3-point floor for all measures with complete 
data in the quality performance category scored against a benchmark in 
the 2020 MIPS payment year (82 FR 30131). However, the Hospital VBP 
Program does not have a corresponding scoring floor. Therefore, we 
proposed to adopt a floor on the Hospital VBP Program Total Performance 
Score for purposes of facility-based measurement under MIPS so that any 
score in the quality performance category, once translated into the 
percentile distribution described above, that would result in a score 
of below 30 percent would be reset to a score of 30 percent in the 
quality performance category (82 FR 30131). We believe that this 
adjustment is important to maintain consistency with our other 
policies. There is no similar floor established for measures in the 
cost performance category under MIPS, so we did not propose any floor 
for the cost performance category for facility-based measurement.
    Some MIPS eligible clinicians who select facility-based measurement 
could have sufficient numbers of attributed patients to meet the case 
minimums for the cost measures established under MIPS. Although there 
is no additional data reporting for cost measures, we believe that, to 
facilitate the relationship between cost and quality measures, they 
should be evaluated covering the same population as opposed to 
comparing a hospital population and a population attributed to an 
individual clinician or group. In addition, we believe that including 
additional cost measures in the cost performance category score for 
MIPS eligible clinicians who elect facility-based measurement would 
reduce the alignment of incentives between the hospital and the 
clinician. Thus, we proposed at Sec.  414.1380(e)(6)(v)(A) that MIPS 
eligible clinicians who elect facility-based measurement would not be 
scored on other cost measures specified for the cost performance 
category, even if they meet the case minimum for a cost measure (82 FR 
30131).
    If a clinician or a group elects facility-based measurement but 
also submits quality data through another MIPS mechanism, we proposed 
to use the higher of the two scores for the quality performance 
category and base the score of the cost performance category on the 
same method (that is, if the facility-based quality performance 
category score is higher, facility-based measurement is used for 
quality and cost) (82 FR 30131). Since this policy may result in a 
higher final score, it may provide facility-based clinicians with a 
substantial incentive to elect facility-based measurement, whether or 
not the clinician believes such measures are the most accurate or 
useful measures of that clinician's performance. Therefore, this policy 
may create an advantage for facility-based clinicians over non-
facility-based clinicians, since non-facility-based clinicians would 
not have the opportunity to use the higher of two scores. Therefore, we 
sought comment on whether this proposal to use the higher score is the 
best approach to score the performance of facility-based clinicians in 
comparison to their non-facility-based peers (82 FR 30131).
    The following is a summary of the public comments received on the 
``Special Rules for Facility-Based Measurement'' proposals and our 
responses:
    Comment: Several commenters supported our proposal that, if a 
clinician or a group elects facility-based measurement but also submits 
quality data through another MIPS mechanism, we use the higher of the 
two scores for the quality performance category and base the score of 
the cost performance category on the same method.
    Response: We thank the commenters for their support.
    Comment: A few commenters stated that giving the higher score of 
the facility-based measurement or another submission was an unfair 
advantage for facility-based clinicians. Some of these commenters 
recommended that those who elect facility-based measurement always be 
scored on it, regardless if another mechanism for submitting quality 
measurement was used.
    Response: We believe that this policy to use the higher of two 
available performance scores is consistent with our other approaches to 
scoring where we have the opportunity to assess performance based on 
two different methods. If another clinician were to submit through two 
different methods of MIPS reporting, we would base the score of that 
clinician on the submission that resulted in the highest score.
    Comment: One commenter supported our proposed 30 percent floor for 
the quality performance category for participants in facility-based 
measurement, noting that it was equitable to other clinicians with 
complete data submission in the quality performance category.
    Response: We thank the commenter for the support.

[[Page 53767]]

    Comment: Several commenters opposed our proposal to establish a 
floor of 30 percent for the quality performance category for clinicians 
and groups participating in facility-based measurement. A few 
commenters noted that score of 30 percent in the quality category is 
equal to 18 points (assuming a quality performance category weight of 
60 percent), which is higher than the 15 point performance threshold 
that CMS has proposed. These commenters suggested that such a floor was 
unfair to other clinicians who would be required to submit data in 
order to receive a score that higher than the performance threshold.
    Response: We continue to believe that this policy is consistent 
with the score that might be received for a clinician who submitted 
data that meet data completeness on six measures through another 
mechanism. Measures scored in the Hospital VBP Program have to meet the 
criteria required for submission through the Hospital IQR Program; 
therefore, we do not believe it would be appropriate to allow a 
clinician to receive a lower score based on the selection of this 
measurement option. We will continue to evaluate this floor in the 
context of scoring policies that are established in the quality 
performance category for other methods of participating in MIPS. We 
also note that this option is not being finalized for the 2018 MIPS 
performance period, so concerns about the minimum score being higher 
than the performance threshold for the 2018 MIPS performance period is 
no longer relevant at this time. We will consider comments on this 
topic in future rulemaking.
    Comment: One commenter recommended that if a clinician or group 
participates in facility-based measurement and submits through another 
mechanism that we use the highest combined quality and cost performance 
category score as opposed to the method which would have the highest 
quality performance category score.
    Response: Because many of the clinicians who qualify for facility-
based measurement would also qualify for an exemption from the 
advancing care information performance category, their quality 
performance category will carry more weight than the cost performance 
category. Because of the possibility of reweighting of this category 
for many clinicians who would use facility-based measurement, we 
believe it is too complex to use the higher combined score. We believe 
that using the option with the higher quality score is simpler and more 
appropriate.
    Final Action: After consideration of the public comments, we are 
finalizing our proposals that clinicians or groups that elect facility-
based measurement but also submit quality data through another MIPS 
mechanism would be measured on the method that results in the higher 
quality score and to establish a 30 percent floor for the quality 
performance category for those who participate in facility-based 
measurement. We are finalizing all other special rules discussed in 
this section as well. We note that facility-based measurement will not 
be available until the 2019 MIPS performance period/2021 MIPS payment 
year so these special rules will not apply until that time.
(5) Scoring the Improvement Activities Performance Category
    Section 1848(q)(5)(C) of the Act specifies scoring rules for the 
improvement activities performance category. For more of the statutory 
background and description of the proposed and finalized policies, we 
refer readers to the CY 2017 Quality Payment Program final rule (81 FR 
77311 through 77319). We have also codified certain requirements for 
the improvement activities performance category at Sec.  
414.1380(b)(3). Based on these criteria, we finalized at Sec.  
414.1380(b)(3) in the CY 2017 Quality Payment Program final rule the 
scoring methodology for this category, which assigns points based on 
certified patient-centered medical home participation or comparable 
specialty practice participation, APM participation, and the 
improvement activities reported by the MIPS eligible clinician (81 FR 
77312). A MIPS eligible clinician's performance will be evaluated by 
comparing the reported improvement activities to the highest possible 
score (40 points). In the CY 2018 Quality Payment Program proposed rule 
(82 FR 30132), we did not propose any changes to the scoring of the 
improvement activities performance category.
(a) Assigning Points to Reported Improvement Activities
    We assign points for each reported improvement activity within 2 
categories: Medium-weighted; and high-weighted activities. Generally, 
each medium-weighted activity is worth 10 points toward the total 
category score of 40 points, and each high-weighted activity is worth 
20 points toward the total category score of 40 points. These points 
are doubled for small practices, practices in rural areas, or practices 
located in geographic HPSAs, and non-patient facing MIPS eligible 
clinicians. We refer readers to Sec.  414.1380(b)(3) and the CY 2017 
Quality Payment Program final rule (81 FR 78312) for further detail on 
improvement activities scoring.
    Activities will be weighted as high based on the extent to which 
they align with activities that support the certified patient-centered 
medical home, since that is consistent with the standard under section 
1848(q)(5)(C)(i) of the Act for achieving the highest potential score 
for the improvement activities performance category, as well as with 
our priorities for transforming clinical practice (81 FR 77311). 
Additionally, activities that require performance of multiple actions, 
such as participation in the Transforming Clinical Practice Initiative 
(TCPI), participation in a MIPS eligible clinician's state Medicaid 
program, or an activity identified as a public health priority (such as 
emphasis on anticoagulation management or utilization of prescription 
drug monitoring programs) are justifiably weighted as high (81 FR 77311 
through 77312).
    We refer readers to Table 26 of the CY 2017 Quality Payment Program 
final rule for a summary of the previously finalized improvement 
activities that are weighted as high (81 FR 77312 through 77313), and 
to Table H of the same final rule, for a list of all the previously 
finalized improvement activities, both medium- and high-weighted (81 FR 
77817 through 77831). We also refer readers to Table F and Table G in 
the appendices of the proposed rule for our proposed additions and 
changes to the Improvement Activities Inventory for Quality Payment 
Program Year 2 and future years (82 FR 30479 and 82 FR 30486 
respectively). In this final rule with comment period, we are 
finalizing the proposed new activities and changes to previously 
adopted activities, some with modification, and refer readers to the 
tables in the appendices of this final rule with comment period for 
details. Consistent with our unified scoring system principles, we 
finalized in the CY 2017 Quality Payment Program final rule that MIPS 
eligible clinicians will know in advance how many potential points they 
could receive for each improvement activity (81 FR 77311 through 
77319).
(b) Improvement Activities Performance Category Highest Potential Score
    At Sec.  414.1380(b)(3), we finalized that we will require a total 
of 40 points to receive the highest score for the improvement 
activities performance category (81 FR 77315). For more of the 
statutory background and description of the proposed and finalized 
policies, we

[[Page 53768]]

refer readers to the CY 2017 Quality Payment Program final rule (81 FR 
77314 through 77315).
    For small practices, practices in rural areas or geographic HPSAs, 
and non-patient facing MIPS eligible clinicians, the weight for any 
activity selected is doubled so that these practices and eligible 
clinicians only need to select one high- or two medium-weighted 
activities to achieve the highest score of 40 points (81 FR 77312).
    In accordance with section 1848(q)(5)(C)(ii) of the Act, we 
codified at Sec.  414.1380(b)(3)(ix) that individual MIPS eligible 
clinicians or groups who are participating in an APM (as defined in 
section 1833(z)(3)(C) of the Act) for a performance period will 
automatically earn at least one half of the highest potential score for 
the improvement activities performance category for the performance 
period (81 FR 30132). In addition, MIPS eligible clinicians that are 
participating in MIPS APMs are assigned an improvement activity score, 
which may be higher than one half of the highest potential score (81 FR 
30132). This assignment is based on the extent to which the 
requirements of the specific model meet the list of activities in the 
Improvement Activities Inventory (81 FR 30132). For a further 
description of improvement activities and the APM scoring standard for 
MIPS, we refer readers to the CY 2017 Quality Payment Program final 
rule (81 FR 77246). For all other individual MIPS eligible clinicians 
or groups, we refer readers to the scoring requirements for individual 
MIPS eligible clinicians and groups in the CY 2017 Quality Payment 
Program final rule (81 FR 77270). An individual MIPS eligible clinician 
or group is not required to perform activities in each improvement 
activities subcategory or participate in an APM to achieve the highest 
potential score in accordance with section 1848(q)(5)(C)(iii) of the 
Act (81 FR 77178).
    In the CY 2017 Quality Payment Program final rule, we also 
finalized that individual MIPS eligible clinicians and groups that 
successfully participate and submit data to fulfill the requirements 
for the CMS Study on Improvement Activities and Measurement will 
receive the highest score for the improvement activities performance 
category (81 FR 77315). We refer readers to the CY 2018 Quality Payment 
Program proposed rule (82 FR 30056) and section II.C.6.e.(10) of this 
final rule with comment period for further detail on this study.
(c) Points for Certified Patient-Centered Medical Home or Comparable 
Specialty Practice
    Section 1848(q)(5)(C)(i) of the Act specifies that a MIPS eligible 
clinician who is in a practice that is certified as a patient-centered 
medical home or comparable specialty practice for a performance period, 
as determined by the Secretary, must be given the highest potential 
score for the improvement activities performance category for the 
performance period. Accordingly, at Sec.  414.1380(b)(3)(iv), we 
specified that a MIPS eligible clinician who is in a practice that is 
certified as a patient-centered medical home, including a Medicaid 
Medical Home, Medical Home Model, or comparable specialty practice, 
will receive the highest potential score for the improvement activities 
performance category (81 FR 77196 through 77180).
    In the CY 2018 Quality Payment Program proposed rule, we did not 
propose any changes specifically to the scoring of the patient-centered 
medical home or comparable specialty practice; however, we did propose 
a change to how groups qualify for this activity (82 FR 30054). We 
refer readers to section II.C.6.e.(2)(a) of this final rule with 
comment period for more details.
(d) Calculating the Improvement Activities Performance Category Score
(i) Generally
    In the CY 2017 Quality Payment Program final rule (81 FR 77318), we 
finalized that individual MIPS eligible clinicians and groups must earn 
a total of 40 points to receive the highest score for the improvement 
activities performance category. To determine the improvement 
activities performance category score, we sum the points for all of a 
MIPS eligible clinician's reported activities and divide by the 
improvement activities performance category highest potential score of 
40. A perfect score will be 40 points divided by 40 possible points, 
which equals 100 percent. If MIPS eligible clinicians have more than 40 
improvement activities points, we will cap the resulting improvement 
activities performance category score at 100 percent (81 FR 77318). For 
example, if more activities are selected than 4 medium-weighted 
activities, the total points that could be achieved is still 40 points 
(81 FR 77318). As stated at (81 FR 77318), the following scoring 
applies to MIPS eligible clinicians generally (who are not a non-
patient facing clinician, a small practice, a practice located in a 
rural area, or a practice in a geographic HPSA):
     Reporting of one medium-weighted activity will result in 
10 points which is one- fourth of the highest score.
     Reporting of two medium-weighted activities will result in 
20 points which is one- half of the highest score.
     Reporting of three medium-weighted activities will result 
in 30 points which is three-fourths of the highest score.
     Reporting of four medium-weighted activities will result 
in 40 points which is the highest score.
     Reporting of one high-weighted activity will result in 20 
points which is one-half of the highest score.
     Reporting of two high-weighted activities will result in 
40 points which is the highest score.
     Reporting of a combination of medium-weighted and high-
weighted activities where the total number of points achieved are 
calculated based on the number of activities selected and the weighting 
assigned to that activity (number of medium-weighted activities 
selected x 10 points + number of high-weighted activities selected x 20 
points) (81 FR 78318).
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30133), 
we did not propose any changes to how we will calculate the improvement 
activities performance category score.
(ii) Small Practices, Practices Located in Rural Areas or Geographic 
HPSAs, and Non- Patient Facing MIPS Eligible Clinicians
    Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to 
give consideration to the circumstances of small practices and 
practices located in rural areas and in geographic HPSAs (as designated 
under section 332(a)(1)(A) of the PHS Act) in defining activities. 
Section 1848(q)(2)(C)(iv) of the Act also requires the Secretary to 
give consideration to non- patient facing MIPS eligible clinicians. 
Further, section 1848(q)(5)(F) of the Act allows the Secretary to 
assign different scoring weights for measures, activities, and 
performance categories, if there are not sufficient measures and 
activities applicable and available to each type of eligible clinician.
    Accordingly, in the CY 2017 Quality Payment Program final rule (81 
FR 77318), we finalized that the following scoring applies to MIPS 
eligible clinicians who are a non-patient facing MIPS eligible 
clinician, a small practice (consisting of 15 or fewer professionals), 
a practice located in a rural area, or practice in a geographic HPSA, 
or any combination thereof:

[[Page 53769]]

     Reporting of one medium-weighted activity will result in 
20 points or one-half of the highest score.
     Reporting of two medium-weighted activities will result in 
40 points or the highest score.
     Reporting of one high-weighted activity will result in 40 
points or the highest score.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30133), 
we did not propose any changes to our policy to give consideration to 
the circumstances of small practices and practices located in rural 
areas and in geographic HPSAs.
(iii) Advancing Care Information Performance Category Bonus
    We finalized in the CY 2017 Quality Payment Program final rule that 
certain activities in the improvement activities performance category 
will also qualify for a bonus under the advancing care information 
performance category (81 FR 78318). This bonus is applied under the 
advancing care information performance category and not under the 
improvement activities performance category (81 FR 78318). For more 
information about our finalized improvement activities scoring policies 
and for several sample scoring charts, we refer readers to the CY 2017 
Quality Payment Program final rule (81 FR 78318 through 78319). In the 
CY 2018 Quality Payment Program proposed rule (82 FR 30059), we did not 
propose any changes to this policy and refer readers to section 
II.C.6.f.(2)(d) of this final rule with comment period for more details 
in the advancing care information performance discussion.
(iv) MIPS APMs
    Finally, in the CY 2017 Quality Payment Program final rule (81 FR 
77319), we codified at Sec.  414.1380(b)(3)(ix) that MIPS eligible 
clinicians participating in APMs that are not certified patient-
centered medical homes will automatically earn a minimum score of one-
half of the highest potential score for the performance category, as 
required by section 1848(q)(5)(C)(ii) of the Act. For any other MIPS 
eligible clinician who does not report at least one activity, including 
a MIPS eligible clinician who does not identify to us that they are 
participating in a certified patient-centered medical home or 
comparable specialty practice, we will calculate a score of zero points 
(81 FR 77319). In the CY 2018 Quality Payment Program proposed rule (82 
FR 30132), we did not propose any changes to this policy.
(e) Self-Identification Policy for MIPS Eligible Clinicians
    In the CY 2017 Quality Payment Program final rule (81 FR 77319), we 
established that individual MIPS eligible clinicians or groups 
participating in APMs would not be required to self-identify as 
participating in an APM, but that all MIPS eligible clinicians would be 
required to self-identify if they were part of a certified patient-
centered medical home or comparable specialty practice, a non-patient 
facing MIPS eligible clinician, a small practice, a practice located in 
a rural area, or a practice in a geographic HPSA, or any combination 
thereof, and that we would validate these self-identifications as 
appropriate.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30133), 
we did not propose any changes to this policy for certified patient-
centered medical homes or comparable specialty practices. MIPS eligible 
clinicians that are part of a certified patient-centered medical home a 
recognized or certified patient-centered medical home or comparable 
specialty practice are still required to self-identify for the 2018 
MIPS performance period, and we will validate these self-
identifications as appropriate.
    For the criteria for recognition as a recognized or certified 
patient-centered medical home or comparable specialty practice, we 
refer readers to the CY 2017 Quality Payment Program final rule (81 FR 
77179 through 77180) and section II.C.6.e.(2)a of this final rule with 
comment period.
    However, in the CY 2018 Quality Payment Program proposed rule (82 
FR 30133), we proposed to no longer require these self-identifications 
for non-patient facing MIPS eligible clinicians, small practices, or 
practices located in rural areas or geographic HPSAs beginning with the 
2018 MIPS performance period, because it is technically feasible for us 
to identify these MIPS eligible clinicians during attestation for the 
performance of improvement activities following the performance period. 
We define these MIPS eligible clinicians in the CY 2017 Quality Payment 
Program final rule (81 FR 77540).
    The following is a summary of the public comments received on the 
``Self-Identification Policy for MIPS Eligible Clinicians'' proposals 
and our responses.
    Comment: Several commenters supported our proposal to remove the 
requirement for MIPS eligible clinicians that are non-patient facing, a 
small practice, a practice located in a rural area, or a practice in a 
geographic HPSA, or any combination thereof to self-identify, stating 
that this will lower the burden of reporting. One commenter urged us to 
also consider ways of eliminating the self-identification requirements 
for MIPS eligible clinicians who participate in patient-centered 
medical homes or comparable specialty practices, for example, by 
requiring the certification and recognition organizations to submit to 
CMS lists of the MIPS eligible clinicians or groups that meet their 
standards and are certified/recognized, similar to how participation 
lists are utilized to determine the participants in certain APMs.
    Response: We thank commenters for their support and suggestions. We 
are attempting to eliminate burden where possible and will continue to 
explore technically feasible ways to reduce burden. We will consider 
the suggestion to also eliminate the need for MIPS eligible clinicians 
who participate in patient-centered medical homes or comparable 
specialty practices to self identify as we craft future policy.
    Final Action: After consideration of the public comments received, 
we are finalizing our proposal, as proposed, to no longer require these 
self-identifications for non-patient facing MIPS eligible clinicians, 
small practices, practices located in rural areas or geographic HPSAs, 
or any combination thereof, beginning with the 2018 MIPS performance 
period and for future years.
(6) Scoring the Advancing Care Information Performance Category
    In the CY 2018 Quality Payment Program proposed rule, we referred 
readers to section II.C.6. of the proposed rule, (82 FR 30057 through 
82 FR 30080) where we discussed scoring the advancing care information 
performance category. We refer readers to section II.C.6.f. of this 
final rule with comment period for finalized policies related to 
scoring the advancing care information performance category.
b. Calculating the Final Score
    For a description of the statutory basis and our policies for 
calculating the final score for MIPS eligible clinicians, we refer 
readers to the discussion in the CY 2017 Quality Payment Program final 
rule (81 FR 77319 through 77329) and Sec.  414.1380. In the proposed 
rule, we proposed to add a complex patient scoring bonus (82 FR 30135 
through 82 FR 30139) and add a small practice bonus to the final score 
(82 FR 30139 through 82 FR 30140). In addition, we reviewed the final 
score calculation for the 2020 MIPS payment year (82 FR

[[Page 53770]]

30140) and proposed refinements to the reweighting policies (82 FR 
30141 through 82 FR 30146).
(1) Accounting for Risk Factors
    Section 1848(q)(1)(G) of the Act requires us to consider risk 
factors in our scoring methodology. Specifically, that section provides 
that the Secretary, on an ongoing basis, shall, as the Secretary 
determines appropriate and based on individuals' health status and 
other risk factors, assess appropriate adjustments to quality measures, 
cost measures, and other measures used under MIPS and assess and 
implement appropriate adjustments to payment adjustments, final scores, 
scores for performance categories, or scores for measures or activities 
under the MIPS. In doing this, the Secretary is required to take into 
account the relevant studies conducted under section 2(d) of the 
Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 
and, as appropriate, other information, including information collected 
before completion of such studies and recommendations.
    In this section, we summarize our efforts related to social risk 
and the relevant studies conducted under section 2(d) of the IMPACT Act 
of 2014. We also finalize some short-term adjustments to address 
patient complexity.
(a) Considerations for Social Risk
    We understand that social risk factors such as income, education, 
race and ethnicity, employment, disability, community resources, and 
social support (certain factors of which are also sometimes referred to 
as socioeconomic status (SES) factors or socio-demographic status (SDS) 
factors) play a major role in health. One of our core objectives is to 
improve beneficiary outcomes, including reducing health disparities, 
and we want to ensure that all beneficiaries, including those with 
social risk factors, receive high quality care. In addition, we seek to 
ensure that the quality of care furnished by providers and suppliers is 
assessed as fairly as possible under our programs while ensuring that 
beneficiaries have adequate access to excellent care.
    We have been reviewing reports prepared by the Office of the 
Assistant Secretary for Planning and Evaluation (ASPE) and the National 
Academies of Sciences, Engineering, and Medicine on the issue of 
accounting for social risk factors in CMS's value-based purchasing and 
quality reporting programs, and considering options on how to address 
the issue in these programs. On December 21, 2016, ASPE submitted the 
first of several Reports to Congress on a study it was required to 
conduct under section 2(d) of the IMPACT Act of 2014. The first study 
analyzed the effects of certain social risk factors in Medicare 
beneficiaries on quality measures and measures of resource use used in 
one or more of nine Medicare value-based purchasing programs.\8\ The 
report also included considerations for strategies to account for 
social risk factors in these programs. A second report due October 2019 
will expand on these initial analyses, supplemented with non-Medicare 
datasets to measure social risk factors. In a January 10, 2017 report 
released by the National Academies of Sciences, Engineering, and 
Medicine, that body provided various potential methods for accounting 
for social risk factors, including stratified public reporting.\9\
---------------------------------------------------------------------------

    \8\ Office of the Assistant Secretary for Planning and 
Evaluation. 2016. Report to Congress: Social Risk Factors and 
Performance Under Medicare's Value-Based Purchasing Programs. 
Available at https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
    \9\ National Academies of Sciences, Engineering, and Medicine. 
2017. Accounting for social risk factors in Medicare payment. 
Washington, DC: The National Academies Press.
---------------------------------------------------------------------------

    In addition, the National Quality Forum (NQF) has concluded their 
initial trial on risk adjustment for quality measures. Based on the 
findings from the initial trial, NQF will continue its work to evaluate 
the impact of social risk factor adjustment on intermediate outcome and 
outcome measures for an additional 3 years. The extension of this work 
will allow NQF to determine further how to effectively account for 
social risk factors through risk adjustment and other strategies in 
quality measurement.
    As we continue to consider the analyses and recommendations from 
these and any future reports, we are continuing to work with 
stakeholders in this process. As we have previously communicated, we 
are concerned about holding providers to different standards for the 
outcomes of their patients with social risk factors because we do not 
want to mask potential disparities or minimize incentives to improve 
the outcomes for disadvantaged populations. Keeping this concern in 
mind, while we sought input on this topic previously, we requested 
public comment on whether we should account for social risk factors in 
the MIPS, and if so, what method or combination of methods would be 
most appropriate for accounting for social risk factors in the MIPS. 
Examples of methods include: Adjustment of MIPS eligible clinician 
scores (for example, stratifying the scores of MIPS eligible clinicians 
based on the proportion of their patients who are dual eligible); 
confidential reporting of stratified measure rates to MIPS eligible 
clinicians; public reporting of stratified measure results; risk 
adjustment of a particular measure as appropriate based on data and 
evidence; and redesigning payment incentives (for instance, rewarding 
improvement for clinicians caring for patients with social risk factors 
or incentivizing clinicians to achieve health equity). We requested 
comments on whether any of these methods should be considered, and if 
so, which of these methods or combination of methods would best account 
for social risk factors in MIPS, if any.
    In addition, we requested public comment on which social risk 
factors might be most appropriate for stratifying measure scores and/or 
potential risk adjustment of a particular measure. Examples of social 
risk factors include, but are not limited to the following: Dual 
eligibility/low-income subsidy; race and ethnicity; and geographic area 
of residence. We also requested comment on which of these factors, 
including current data sources where this information would be 
available, could be used alone or in combination, and whether other 
data should be collected to better capture the effects of social risk. 
We noted that we will take commenters' input into consideration as we 
continue to assess the appropriateness and feasibility of accounting 
for social risk factors in MIPS. We noted that any such changes would 
be proposed through future notice and comment rulemaking.
    We look forward to working with stakeholders as we consider the 
issue of accounting for social risk factors and reducing health 
disparities in CMS programs. Of note, implementing any of the above 
methods would be taken into consideration in the context of how this 
and other CMS programs operate (for example, data submission methods, 
availability of data, statistical considerations relating to 
reliability of data calculations, among others); we also welcome 
comment on operational considerations. CMS is committed to ensuring 
that its beneficiaries have access to and receive excellent care, and 
that the quality of care furnished by providers and suppliers is 
assessed fairly in CMS programs.
    In response to our requests for comments described previously in 
this final rule with comment period, many commenters provided feedback 
on addressing social risk. As we have previously stated, we are 
concerned

[[Page 53771]]

about holding providers to different standards for the outcomes of 
their patients with social risk factors, because we do not want to mask 
potential disparities. We believe that the path forward should 
incentivize improvements in health outcomes for disadvantaged 
populations while ensuring that beneficiaries have adequate access to 
excellent care. We thank commenters for this important feedback and 
will continue to consider options to account for social risk factors 
that would allow us to view disparities and potentially incentivize 
improvement in care for patients and beneficiaries. We will consider 
the comments we received in preparation for future rulemaking.
(b) Complex Patient Bonus
    While we work with stakeholders on these issues as we have 
described, under the authority within section 1848(q)(1)(G) of the Act, 
which allows us to assess and implement appropriate adjustments to 
payment adjustments, MIPS final scores, scores for performance 
categories, or scores for measures or activities under MIPS, we 
proposed to implement a short-term strategy for the Quality Payment 
Program to address the impact patient complexity may have on final 
scores (82 FR 30135 through 82 FR 30139). The overall goal when 
considering a bonus for complex patients is two-fold: (1) To protect 
access to care for complex patients and provide them with excellent 
care; and (2) to avoid placing MIPS eligible clinicians who care for 
complex patients at a potential disadvantage while we review the 
completed studies and research to address the underlying issues. We 
used the term ``patient complexity'' to take into account a multitude 
of factors that describe and have an impact on patient health outcomes; 
such factors include the health status and medical conditions of 
patients, as well as social risk factors. We believe that as the number 
and intensity of these factors increase for a single patient, the 
patient may require more services, more clinician focus, and more 
resources in order to achieve health outcomes that are similar to those 
who have fewer factors. In developing the policy for the complex 
patient bonus, we assessed whether there was a MIPS performance 
discrepancy by patient complexity using two well-established indicators 
in the Medicare program. The proposal was intended to address any 
discrepancy, without masking performance. Because this bonus is 
intended to be a short-term strategy, we proposed the bonus only for 
the 2018 MIPS performance period (2020 MIPS payment year) and noted we 
will assess on an annual basis whether to continue the bonus and how 
the bonus should be structured (82 FR 30135 through 30139).
    When considering approaches for a complex patient bonus, we 
reviewed evidence to identify how indicators of patient complexity have 
an impact on performance under MIPS as well as availability of data to 
implement the bonus. We estimated the impact on performance using our 
proposed scoring model, described in more detail in the regulatory 
impact analysis of the CY 2018 Quality Payment Program proposed rule 
(82 FR 30235 through 30238) that uses historical PQRS data to simulate 
scores for MIPS eligible clinicians including estimates for the 
quality, advancing care information, and improvement activities 
performance categories, and the small practice bonus (82 FR 30149 
through 30150). These estimates reflect scoring proposals with the cost 
performance category weight at zero percent. We identified two 
potential indicators for complexity: Medical complexity as measured 
through Hierarchical Condition Category (HCC) risk scores and social 
risk as measured through the proportion of patients with dual eligible 
status. We identified these indicators because they are common 
indicators of patient complexity in the Medicare program and the data 
is readily available. Please refer to the CY 2018 Quality Payment 
Program proposed rule for a detailed discussion of our analysis of both 
indicators that informed our proposal (82 FR 30135 through 30138).
    We proposed at Sec.  414.1380(c)(3) to add a complex patient bonus 
to the final score for the 2020 MIPS payment year for MIPS eligible 
clinicians that submit data for at least one performance category (82 
FR 30138). We proposed at Sec.  414.1380(c)(3)(i) to calculate an 
average HCC risk score, using the model adopted under section 1853 of 
the Act for Medicare Advantage risk adjustment purposes, for each MIPS 
eligible clinician or group, and to use that average HCC risk score as 
the complex patient bonus. We proposed to calculate the average HCC 
risk score for a MIPS eligible clinician or group by averaging HCC risk 
scores for beneficiaries cared for by the MIPS eligible clinician or 
clinicians in the group during the second 12-month segment of the 
eligibility period, which spans 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 (September 
1, 2017 to August 31, 2018 for the 2018 MIPS performance period). We 
proposed the second 12-month segment of the eligibility period to align 
with other MIPS policies and to ensure we have sufficient time to 
determine the necessary calculations. The second period 12-month 
segment overlaps 8-months with the MIPS performance period which means 
that many of the patients in our complex patient bonus would have been 
cared for by the clinician, group, virtual group, or APM Entity during 
the MIPS performance period.
    HCC risk scores for beneficiaries would be calculated based on the 
calendar year immediately prior to the performance period. For the 2018 
MIPS performance period, the HCC risk scores would be calculated based 
on beneficiary services from the 2017 calendar year. We proposed this 
approach because CMS uses prior year diagnoses to set Medicare 
Advantage rates prospectively every year and has employed this approach 
in the VM (77 FR 69317 through 69318). Additionally, this approach 
mitigates the risk of ``upcoding'' to get higher expected costs, which 
could happen if concurrent risk adjustments were incorporated. We noted 
that we realized using the 2017 calendar year to assess beneficiary HCC 
risk scores overlaps by 4 months with the 12-month data period to 
identify beneficiaries (which is September 1, 2017 to August 31, 2018 
for the 2018 MIPS performance period); however, we annually calculate 
the beneficiary HCC risk score and use it for multiple purposes (like 
the Physician and Other Supplier Public Use File).
    For MIPS APMs and virtual groups, we proposed at Sec.  
414.1380(c)(3)(ii) to use the beneficiary weighted average HCC risk 
score for all MIPS eligible clinicians, and if technically feasible, 
TINs for models and virtual groups which rely on complete TIN 
participation, within the APM Entity or virtual group, respectively, as 
the complex patient bonus. We would calculate the weighted average by 
taking the sum of each individual clinician's (or TIN's as appropriate) 
average HCC risk score multiplied by the number of unique beneficiaries 
cared for by the clinician and then divide by the sum of the 
beneficiaries cared for by each individual clinician (or TIN as 
appropriate) in the APM Entity or virtual group.
    We proposed at Sec.  414.1380(c)(3)(iii) that the complex patient 
bonus cannot exceed 3 points. We divided clinicians and groups into 
quartiles based on average HCC risk score and percentage of patients 
who are dual eligible. A cap of 3 points was selected because the 
differences in performance we observed

[[Page 53772]]

in simulated scores (based on our proposed scoring methodology) between 
the first and fourth quartiles of average HCC risk scores was 
approximately 4 points for individuals and approximately 5 points for 
groups. The 95th percentile of average HCC risk score values for 
individual clinicians was 2.91 which we rounded to 3 for simplicity. 
Although we considered using a higher cap to reflect the differences in 
performance above 4 points, we believed that 3 points was appropriate 
in order to not mask poor performance and because we estimated that 
most MIPS eligible clinicians would have an average HCC risk score 
below 3 points.
    We expressed our belief that applying this bonus to the final score 
is appropriate because caring for complex and vulnerable patients can 
affect all aspects of a practice and not just specific performance 
categories. It may also create a small incentive to provide access to 
complex patients. We considered whether we should apply a set number of 
points to those in a specific quartile (for example, for the highest 
risk quartile only), but did not want to restrict the bonus to only 
certain MIPS eligible clinicians. Rather than assign points based on 
quartile, we believed that adding the average HCC risk score directly 
to the final score would achieve our goal of accounting for patient 
complexity without masking low performance and does provide a modest 
effect on the final score.
    Finally, we proposed that the MIPS eligible clinician, group, 
virtual group, or APM Entity must submit data on at least one measure 
or activity in a performance category during the performance period to 
receive the complex patient bonus. Under this proposal, MIPS eligible 
clinicians would not need to meet submission requirements for the 
quality performance category in order to receive the bonus (they could 
instead submit improvement activities or advancing care information 
measures only or submit fewer than the required number of measures for 
the quality performance category).
    Based on our data analysis using our proposed scoring model with 
the cost performance category weighted at zero percent, we estimated 
that this bonus on average would range from 1.16 points in the first 
quartile of MIPS eligible clinicians when ranked by average HCC risk 
scores to 2.49 points in the fourth quartile for individual reporters 
submitting 6 or more measures, and 1.26 points in the first quartile to 
2.23 points in the fourth quartile for group reporters. For example, a 
MIPS eligible clinician with a final score of 55.11 with an average HCC 
risk score of 2.01 would receive a final score of 57.12. We proposed 
(82 FR 30140) to modify the final score calculation formula so that if 
the result of the calculation is greater than 100 points, then the 
final score would be capped at 100 points.
    We also sought comment on an alternative complex patient bonus 
methodology, similarly for the 2020 MIPS payment year only (82 FR 
30139). Under the alternative, we would apply a complex patient bonus 
based on a ratio of patients who are dual eligible because dual 
eligible status is a common indicator of social risk for which we 
currently have data available. We expressed our belief that the 
advantage of this option is its relative simplicity and that it creates 
a direct incentive to care for dual eligible patients, who are often 
medically complex and have concurrent social risk factors. In addition, 
whereas the HCC risk scores rely on the diagnoses a beneficiary 
receives which could be impacted by variations in coding practices 
among clinicians, the dual eligibility ratio is not impacted by 
variations in coding practices. For this alternative option, we would 
calculate a dual eligible ratio (including both full and partial 
Medicaid beneficiaries) for each MIPS eligible clinician based on the 
proportion of unique patients who have dual eligible status seen by the 
MIPS eligible clinician among all unique patients seen during the 
second 12-month segment of the eligibility period, which spans 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. For MIPS APMs 
and virtual groups, we would use the average dual eligible patient 
ratio for all MIPS eligible clinicians, and if technically feasible, 
TINs for models and virtual groups which rely on complete TIN 
participation, within the APM Entity or virtual group, respectively.
    Under this alternative option, we would identify dual eligible 
status (numerator of the ratio) using data on dual-eligibility status 
sourced from the state Medicare Modernization Act (MMA) files, which 
are files each state submits to CMS with monthly Medicaid eligibility 
information. We would use dual-eligibility status data from the state 
MMA files because it is the best available data for identifying dual 
eligible beneficiaries. Under this alternative option, we would include 
both full-benefit and partial benefit beneficiaries in the dual 
eligible ratio, and an individual would be counted as a dual patient if 
they were identified as a full-benefit or partial-benefit dual patient 
in the state MMA files at the conclusion of the second 12-month segment 
of the eligibility determination period.
    We proposed to define the proportion of full-benefit or partial-
benefit dual eligible beneficiaries as the proportion of dual eligible 
patients among all unique Medicare patients seen by the MIPS eligible 
clinician or group during the second 12-month segment of the 
eligibility period which spans from the last 4 months of a calendar 
year prior to the performance period followed by the first 8 months of 
the performance period in the next calendar year (September 1, 2017 to 
August 31, 2018 for the 2018 MIPS performance period), to identify MIPS 
eligible clinicians for calculation of the complex patient bonus. This 
date range aligns with the second low-volume threshold determination 
and also represents care provided during the performance period.
    We proposed to multiply the dual eligible ratio by 5 points to 
calculate a complex patient bonus for each MIPS eligible clinician. For 
example, a MIPS eligible clinician who sees 400 patients with dual 
eligible status out of 1,000 total Medicare patients seen during the 
second 12-month segment of the eligibility period would have a complex 
patient ratio of 0.4, which would be multiplied by 5 points for a 
complex patient bonus of 2 points toward the final score. We believe 
this approach would be simple to explain and would be available to all 
clinicians who care for dual eligible beneficiaries. We also believed a 
complex patient bonus ranging from 1 to 5 points (with most MIPS 
eligible clinicians receiving a bonus between 1 and 3 points) would be 
appropriate because, in our analysis, we estimated differences in 
performance between the 1st and 4th quartiles of dual eligible ratios 
to be approximately 3 points for individuals and approximately 6 points 
for groups. A bonus of less than 5 points would help to mitigate the 
impact of caring for patients with social risk factors while not 
masking poor performance. Using this approach, we estimated that the 
bonus would range from 0.45 (first dual quartile) to 2.42 (fourth dual 
quartile) for individual reporters, and from 0.63 (first dual quartile) 
to 2.19 (fourth dual quartile) for group reporters. Under this 
alternative option, we would also include the complex patient bonus in 
the calculation of the final score. We proposed that if the result of 
the calculation is greater than 100 points, then the final score would 
be capped at 100 points (82 FR 30140). We sought comments on our 
proposed bonus for

[[Page 53773]]

complex patients based on average HCC risk scores, and our alternative 
option using a ratio of dual eligible patients in lieu of average HCC 
risk scores. We reiterated that the complex patient bonus is intended 
to be a short-term solution, which we plan to revisit on an annual 
basis, to incentivize clinicians to care for patients with medical 
complexity. We noted that we may consider alternate adjustments in 
future years after methods that more fully account for patient 
complexity in MIPS have been developed. We also requested comments on 
alternative methods to construct a complex patient bonus.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters requested that CMS base the complex 
patient bonus on both HCC risk scores and dual eligibility. The 
commenters expressed the belief that both of these indicators capture 
important aspects of patient risk, and together provide a more complete 
picture. The commenters suggested that CMS apply a complex patient 
bonus if a MIPS eligible clinician meets a defined threshold for either 
HCC risk scores or proportion of patients who are dual eligible. One 
commenter requested that CMS provide separate bonuses based on HCC risk 
scores and the proportion of patients who are dual eligible.
    Response: We appreciate these comments and have decided to finalize 
a modified complex patient bonus which will be added to the final score 
that includes the sum of the average HCC risk scores and proportion of 
dual eligible beneficiaries (multiplied by 5 points), subject to a 5-
point cap. We believe combining these two indicators is appropriate 
because, while these two indicators are correlated (with a correlation 
coefficient of 0.487 based on our updated model, which includes 2016 
PQRS data and the cost performance category weighted at 10 percent of 
the final score), they are not interchangeable. We believe adding these 
two indicators together recognizes the strengths of both approaches, as 
well as the limitations of either approach in fully accounting for 
patient complexity. We believe including both indicators will account 
for MIPS eligible clinicians who see medically complex patients but do 
not see many patients who are dual eligible, as well as MIPS eligible 
clinicians who see dual eligible patients but do not see many medically 
complex patients as defined by HCC risk scores.
    As discussed later in this section, a 5-point cap was requested by 
several commenters. While we did not want to mask poor performance, we 
believe raising the cap to 5 points could be supported by the data and 
would align with the small practice bonus. Using our proposed scoring 
model, we observed a decrease in simulated scores of approximately 4 
points (for individuals who report 6 or more quality measures) and 
approximately 5 points (for groups) from the top quartile to the bottom 
quartile for the average patient HCC risk score. Our updated model 
showed similar distribution. We believe that the 3-point cap we 
proposed was justified in order to not mask poor performance, given the 
differences in quartiles scores, and we believe a cap of 5 points could 
also be supported. Using our updated scoring model (described in the 
regulatory impact analysis section VI.D of this final rule with comment 
period), we estimate a decrease in simulated scores of 5.4 points (for 
individuals who report 6 or more quality measures) and 4.5 points (for 
groups) from the top quartile to the bottom quartile for the average 
patient HCC risk scores and 4.8 points (for individuals who report 6 or 
more quality measures) and 4.5 points (for groups) from the top 
quartile to the bottom quartile for the dual eligible ratio. Therefore, 
we believe a cap for the complex patient bonus of 5 points is supported 
by this updated data with slightly higher differences in performance 
based on HCC risk scores and dual eligibility.
    We do not believe that adopting a threshold is appropriate at this 
time because it would add additional complexity. In addition, a 
threshold would likely create an artificial ``cliff,'' where MIPS 
eligible clinicians just above the threshold would receive a bonus 
while those just below the threshold would not, even though the 
differences in patient populations between these two groups may be very 
minimal. We also believe that separate bonuses for complex patients (as 
opposed to a single combined score) may add unnecessary confusion to 
MIPS eligible clinicians.
    Comment: Many commenters supported the complex patient bonus but 
requested that CMS increase the maximum number of points for the bonus. 
Most of these commenters supported a cap of 5 points. The commenters 
expressed the belief that MIPS eligible clinicians should have the 
opportunity to receive as many points for the complex patient bonus as 
they receive for the small practice bonus because commenters believe 
patient complexity can have as much of an impact on performance as 
practice size. The commenters furthermore believe that a bonus of only 
1 to 3 points would have only a modest impact on the final score. A few 
commenters requested that CMS adopt the same cap for HCC risk scores 
that is used in the Next Generation ACO Model or Shared Savings 
Program, where the HCC risk score cannot increase by more than 3 
percent.
    Response: We acknowledge the commenters' concern that a 3-point cap 
would have only a modest impact on the final score and would not be 
aligned with the small practice bonus. For the reasons described 
earlier, we believe a 5-point cap for the complex patient bonus is 
justified and are finalizing it for the 2020 MIPS payment year. We 
think the 5 points will have slightly more impact on the final score 
(while not masking poor performance) and is justified by the data. In 
response to comments to adopt the cap used in the Next Generation ACO 
Model or Shared Savings Program, we note that we are not currently 
measuring increases in HCC risk scores over time but will evaluate any 
impacts on diagnosis coding should the complex patient bonus continue.
    Comment: Many commenters supported CMS's proposal to apply a 
complex patient bonus to the final score based on HCC risk scores. The 
commenters agreed that the complex patient bonus will help address the 
resources needed to treat complex patients, without masking clinician 
performance. Furthermore, the commenters believe that the complex 
patient bonus will help protect access to care and offset incentives to 
avoid treating the sickest patients. The commenters supported HCC risk 
scores as a valid proxy for medical complexity, believing that it is 
familiar to stakeholders.
    Response: We appreciate the support of commenters for the proposed 
complex patient bonus for the 2020 MIPS payment year. We continue to 
believe HCC risk scores is a valid complex patient indicator and will 
be incorporating this into the complex patient bonus along with the 
dual eligible ratio, for the reasons described earlier. As we stated in 
the CY 2018 Quality Payment Program proposed rule, we intend to monitor 
the effect of the complex patient bonus and revisit future adjustments 
or the continued need for an extension of the bonus through rulemaking.
    Comment: Several commenters supported CMS's proposal to apply a 
complex patient bonus but expressed the belief that the bonus, 
particularly when combined with other bonuses at the performance 
category level and at the final score level, creates confusion for MIPS 
eligible clinicians.

[[Page 53774]]

Commenters urged CMS to align our approaches across these various 
bonuses as much as possible to enhance stability and predictability for 
MIPS eligible clinicians. Several commenters requested that CMS extend 
the complex patient bonus to future years, in order to increase 
stability in the Quality Payment Program and to help MIPS eligible 
clinicians better predict which bonuses they will receive. The 
commenters expressed the belief that modifying bonus points each year 
will add complexity to the program and increase confusion for MIPS 
eligible clinicians.
    Response: We acknowledge the need for simplicity and predictability 
in our MIPS scoring policies. For the reasons described earlier in this 
final rule comment period, we are modifying the complex patient bonus 
to incorporate dual eligibility and HCC risk scores with a 5-point cap 
to better align with the small practice bonus. We also agree with 
commenters that, to the extent possible, we should try to maintain 
stability over time in our approach to account for social risk in order 
to minimize confusion and complexity for MIPS eligible clinicians. 
However, as we note earlier in this final rule with comment period, we 
intend this complex patient bonus as a short-term solution to account 
for risk factors in MIPS as we continue to evaluate ongoing research in 
this area as well as review available data to support various 
approaches to accounting for risk factors. We plan to review results of 
implementation of the complex patient bonus in the 2020 MIPS payment 
year, as well as available reports, and as appropriate, update our 
approach to accounting for risk factors.
    Comment: A few commenters expressed support for CMS's alternative 
approach to calculate a complex patient bonus based on proportion of 
patients who are dual eligible. The commenters supported dual 
eligibility as a proxy for social risk factors, an approach that is 
currently used in the Medicare Advantage star ratings methodology. The 
commenters stated that dual eligible patients are a high-cost, high-
risk population, and, therefore, the proportion of patients who are 
dual eligible is an appropriate indicator of social risk. The 
commenters further expressed concern with limitations in using HCC risk 
scores, which they believe are subject to variations in coding 
practices.
    Response: We thank the commenters for their support. We agree that 
dual eligibility is an appropriate indicator, and for the reasons 
explained previously, we are including a dual eligibility ratio in the 
calculation of the complex patient bonus.
    Comment: Some commenters who supported CMS's proposal to apply a 
complex patient bonus based on HCC risk scores pointed out some 
limitations in using HCC risk scores for this purpose for our 
consideration as we consider alternate methods in future years. For 
example, some commenters expressed the belief that HCC risk scores are 
subject to differences in coding, rather than being completely tied to 
patient complexity. A few commenters stated that HCC risk scores are of 
limited value due to the inadequacy of coding systems. For example, a 
few commenters noted that inadequate coding exists for behavioral 
health conditions, oncology, pediatrics, and rare diseases. Further, 
the commenters expressed the belief that, even though HCC risk scores 
include dual eligibility as one component, they do not adequately 
capture social determinants of health. Some commenters further pointed 
out that in the VM program, clinicians who cared for patients with high 
HCC risk scores were more likely to receive negative payment 
adjustments. A few commenters urged CMS to identify appropriate 
adjustment mechanisms for quality measures in addition to the complex 
patient bonus.
    Response: We understand that HCC risk scores have some limitations, 
particularly in that the HCC values depends on coding to capture 
medical complexity and coding may not capture all of a patient's 
medical conditions. However, we are unaware of other options that are 
readily available that would be a more complete index of a patient's 
medical complexity. We have decided to pair the HCC risk score with the 
proportion of dual eligible patients to create a more complete complex 
patient indicator than can be captured using HCC risk scores alone. We 
note that the complex patient bonus would be available to all MIPS 
eligible clinicians who submit data on at least one measure or activity 
in a performance category, unlike in the VM program, which limits the 
bonus for caring for high-risk beneficiaries to clinicians who qualify 
for upward adjustments. We will evaluate additional options in future 
years in order to better account for social risk factors while 
minimizing unintended consequences.
    Comment: One commenter urged CMS to look to POS codes (POS 31 SNF; 
POS 32 NF) to provide further granularity in assessing the complexity 
of clinicians' patient populations given the complexity of populations 
in these settings.
    Response: We thank the commenter for this suggestion. We take into 
consideration better accounting for the complexity of patients in these 
facility settings in future rulemaking.
    Comment: One commenter requested that the complex patient bonus be 
determined based on new patient relationship codes, with a field to 
document patient complexity.
    Response: Thank you for this comment. We do not believe it is 
feasible to include patient complexity with patient relationship codes 
at this time, but we will take it into consideration in future 
rulemaking.
    Comment: A few commenters suggested that CMS offer education to 
MIPS eligible clinicians on appropriate coding practices to enhance the 
validity of HCC risk scores.
    Response: Our intent in adopting a methodology for the complex 
patient bonus based on HCC risk scores is to capture differences in 
patient complexity, rather than differences in clinician coding 
practices. We are aware that variations in coding practices may impact 
HCC risk scores, but are unaware of other readily available indicators 
that would better capture medical complexity. We intend to provide 
guidance to MIPS eligible clinicians on calculation of the complex 
patient bonus. As described earlier, we are also incorporating 
proportion of dual eligible beneficiaries in to the complex patient 
bonus and plan to develop appropriate educational materials.
    Comment: Several commenters did not support the proposed complex 
patient bonus for the 2020 MIPS payment year. Several commenters 
expressed the belief that the proposed approach is too complex, while 
others stated that because CMS have not yet identified an ideal method 
to adjust for patient complexity, CMS should delay any bonus at this 
time. A few commenters expressed the belief that implementing a complex 
patient bonus that CMS plans to modify in future years will add 
unnecessary confusion for MIPS eligible clinicians. A few commenters 
stated that all of the various bonuses available under MIPS add a great 
deal of complexity and uncertainty to the program. One commenter stated 
that HCC risk scores tend to be lower for rural practices, citing 
MedPAC's 2012 report on rural providers.
    Response: While we work with stakeholders to identify a more 
comprehensive, long-term approach to account for social risk factors, 
we continue to believe a short-term strategy for the Quality Payment 
Program based on data we have available to us is appropriate, despite 
its limitations, to

[[Page 53775]]

address the impact of patient complexity. We are also finalizing a 
revised complex patient bonus based on HCC risk scores and dual 
eligibility with a 5-point cap for reasons described earlier. We intend 
to identify additional ways we can minimize complexity in our approach 
to accounting for social risk factors in future rulemaking. We also 
intend to monitor for any disparities in HCC risk scores based on 
whether a practice is located in a rural area, but in the meantime, we 
are also incorporating a dual eligibility component to the complex 
patient bonus which we believe will mitigate some concerns about basing 
the complex patient bonus on HCC risk scores alone.
    Comment: Several commenters did not support the use of dual 
eligibility for calculating a complex patient bonus. For example, 
several commenters expressed their belief that dual eligibility is not 
a good proxy for social risk factors. The commenters pointed out that 
Medicaid eligibility varies by state, particularly based on recent 
trends in Medicaid expansion. A few commenters stated that HCC risk 
scores are a more familiar concept to MIPS eligible clinicians than 
dual eligibility.
    Response: We continue to believe that dual eligibility is a valid 
proxy for social risk factors which impacts performance in MIPS, which 
has been used to account for social risk in other CMS programs, such as 
Medicare Advantage star ratings. We note that HCC risk scores include 
dual eligibility as one factor; however, we acknowledge that these two 
indicators are not interchangeable (correlation coefficient of 0.487) 
as HCC risk scores also include other aspects of social complexity 
(such as medical diagnoses). We are aware that dual eligibility may 
vary by state, and we plan to continue to monitor alternative 
approaches to accounting for social risk in the future.
    Comment: One commenter requested that CMS use data from the 
performance period rather than prospective data because this approach 
does not account for new diagnoses.
    Response: As we discussed above, Medicare Advantage uses prior year 
diagnoses to set rates prospectively every year and we have employed 
this approach in the VM (77 FR 69317 through 69318). While using data 
from a prior period may not capture any new diagnoses for a patient, it 
also mitigates the risk of ``upcoding'' which could happen if 
concurrent risk adjustments were incorporated.
    Comment: One commenter requested that CMS provide information on 
the number of MIPS eligible clinicians who would be eligible for a 
complex patient bonus under each of the two options, as well as the 
overlap between the two.
    Response: Under both options, all MIPS eligible clinicians would 
receive a complex patient bonus as long as they submit data on at least 
one measure or activity in a performance category; however, those with 
higher complexity would receive a higher bonus score. Based on our 
updated analysis, we estimate the median complex patient bonus would be 
just under 3 points (2.97). Additional information can be found in 
Table 27 of this final rule with comment period.
    Comment: Several commenters suggested additional risk factors to 
consider for bonuses. Several commenters requested that CMS incorporate 
a bonus for MIPS eligible clinicians who care for American Indian/
Alaska Native patients because these patients tend to be more complex, 
with a greater disease burden, and because clinicians caring for these 
patients tend to have decreased resources. The commenters also 
requested that CMS provide bonus points based on frailty, Adverse 
Childhood Events (ACE), social risk factors, and other factors not 
currently captured in the HCC risk score methodology. Several 
commenters offered suggestions for future enhancements of the complex 
patient bonus to ensure that it achieves the goals CMS has outlined 
while reducing confusion and complexity for MIPS eligible clinicians 
wherever possible. The commenters acknowledged that the proposed 
approach has several limitations that must be addressed over time. The 
commenters urged CMS to use the first year of the complex patient bonus 
to monitor the impact of the complex patient bonus, receive feedback 
from stakeholders, and explore more appropriate methods of accounting 
for patient complexity, while continuing to monitor reports released by 
NQF, ASPE, and others. The commenters also requested that CMS identify 
ways to better account for certain patient populations, such as 
patients with rare diseases.
    Response: We appreciate these comments suggesting ways that we can 
continue to enhance the complex patient bonus. We intend to explore 
additional risk factors, as appropriate, as we consider approaches to 
account for social risk in the future in the Quality Payment Program. 
As noted in the CY 2018 Quality Payment Program proposed rule (82 FR 
30135), our goals for the complex patient bonus are (1) to protect 
access to care for complex patients and provide them with excellent 
care; and (2) to avoid placing MIPS eligible clinicians who care for 
complex patients at a potential disadvantage while we review the 
completed studies and research to address the underlying issues. 
Keeping these goals in mind, we also recognize the value of maintaining 
stability wherever possible to reduce clinician confusion. Therefore, 
we intend to take into consideration feedback we have received as we 
consider approaches to account for social risk in future years that 
minimize confusion and complexity in the Quality Payment Program.
    Comment: One commenter suggested that CMS provide an exclusion to 
the Quality Payment Program for clinicians who treat complex patients 
because such an exclusion would reduce unnecessary risks and 
uncertainties for MIPS eligible clinicians and impact treatment access.
    Response: We do not have statutory authority to exclude MIPS 
eligible clinicians based on patient complexity.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal with modification for the 2020 MIPS payment 
year. We are finalizing at Sec.  414.1380(c)(3) a complex patient bonus 
for MIPS eligible clinicians, groups, APM Entities, and virtual groups 
that submit data for at least one MIPS performance category during the 
applicable performance period, which will be added to the final score. 
We are finalizing at Sec.  414.1380(c)(3)(i) to calculate the complex 
patient bonus for MIPS eligible clinicians and groups by adding the 
average HCC risk score to the dual eligible ratio, based on full 
benefit and partial benefit dual eligible beneficiaries, multiplied by 
5. We are finalizing at Sec.  414.1380(c)(3)(ii) to calculate the 
complex patient bonus for APM Entities and virtual groups by adding the 
beneficiary weighted average HCC risk score for all MIPS eligible 
clinicians, and if technically feasible, TINs for models and virtual 
groups which rely on complete TIN participation, within the APM Entity 
or virtual group, respectively, to the average dual eligible ratio for 
all MIPS eligible clinicians, and if technically feasible, TINs for 
models and virtual groups which rely on complete TIN participation, 
within the APM Entity or virtual group, respectively, multiplied by 5. 
We will calculate the average HCC risk score and dual eligible ratio as 
described in the proposed rule (82 FR 30138 through 30139). We are 
finalizing at Sec.  414.1380(c)(3)(iii) that the complex patient bonus 
cannot exceed 5 points.

[[Page 53776]]

    Using our scoring model, we estimate that the average complex 
patient bonus will range from 2.52 in the first HCC quartile to 3.72 in 
the highest HCC quartile for all MIPS eligible clinicians. Table 27 
includes the distribution for the complex patient bonus under our final 
policy, along with bonuses based on the proposed approach (based on HCC 
risk scores only) and the alternate approach (based on dual eligible 
ratio).

            Table 27--Estimated Complex Patient Bonus for Finalized, Proposed, and Alternate Approach
----------------------------------------------------------------------------------------------------------------
                                                                                   Dual bonus **
                                                                    HCC bonus *      (2018 QPP      HCC + dual
                                                                     (2018 QPP     proposed rule   bonus (final
                                                                  proposed rule)     alternate        policy)
                                                                                     proposal)
----------------------------------------------------------------------------------------------------------------
                                                  HCC Quartile
----------------------------------------------------------------------------------------------------------------
Quartile 1--Lowest Average HCC Score............................            1.26            1.33            2.52
Quartile 2......................................................            1.51            1.56            3.06
Quartile 3......................................................            1.63            1.81            3.43
Quartile 4--Highest Average HCC Score...........................            1.86            1.97            3.72
----------------------------------------------------------------------------------------------------------------
                                             Dual Eligible Quartile
----------------------------------------------------------------------------------------------------------------
Quartile 1--Low Proportion of Dual Eligible.....................            1.42            0.84            2.19
Quartile 2......................................................            1.54            1.36            2.85
Quartile 3......................................................            1.68            2.01            3.68
Quartile 4--Highest Proportion of Dual Eligible.................            1.64            2.46            4.02
----------------------------------------------------------------------------------------------------------------
* Includes a 3-point cap.
** Calculated as dual eligible ratio times 5.

(c) Small Practice Bonus for the 2020 MIPS Payment Year
    Eligible clinicians and groups who work in small practices are a 
crucial part of the health care system. The Quality Payment Program 
provides options designed to make it easier for these MIPS eligible 
clinicians and groups to report on performance and quality and 
participate in advanced alternative payment models for incentives. We 
have heard directly from clinicians in small practices that they face 
unique challenges related to financial and other resources, 
environmental factors, and access to health information technology. We 
heard from many commenters that the Quality Payment Program gives an 
advantage to large organizations because such organizations have more 
resources invested in the infrastructure required to track and report 
measures to MIPS. We also observed that, based on our scoring model, 
which is described in the regulatory impact analysis in the CY 2018 
Quality Payment Program proposed rule (82 FR 30233 through 30241), 
practices with more than 100 clinicians may perform better in the 
Quality Payment Program, on average, compared to smaller practices. We 
believe this trend is due primarily to two factors: participation rates 
and submission mechanism. Based on the most recent PQRS data available, 
practices with 100 or more MIPS eligible clinicians have participated 
in the PQRS at a higher rate than small practices (99.4 percent 
compared to 69.7 percent, respectively). As we indicate in our 
regulatory impact analysis in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30233 through 30241), we believe participation 
rates based only on historic 2015 quality data submitted under PQRS 
significantly underestimate the expected participation in MIPS 
particularly for small practices. Therefore, we have modeled the 
regulatory impact analysis using minimum participation assumptions of 
80 percent and 90 percent participation for each practice size category 
(1-15 clinicians, 16-24 clinicians, 25-99 clinicians, and 100 or more 
clinicians). However, even with these enhanced participation 
assumptions, MIPS eligible clinicians in small practices would have 
lower participation in MIPS than MIPS eligible clinicians in larger 
practices have had in PQRS, as 80 or 90 percent participation is still 
much lower than the 99.4 percent PQRS participation for MIPS eligible 
clinicians in practices with 100 or more clinicians.
    In addition, the most recent PQRS data (from CY 2016) indicates 
practices with 100 or more MIPS eligible clinicians are more likely to 
report as a group, rather than individually, which reduces burden to 
individuals within those practices due to the unified nature of group 
reporting. Specifically, 62.1 percent of practices with 100 or more 
MIPS eligible clinicians have reported via CMS Web Interface (either 
through the Shared Savings Program or as a group practice) compared to 
22.4 percent of small practices (the CMS Web Interface reporting 
mechanism is only available to small practices participating in the 
Shared Savings Program or Next Generation ACO Model).\10\
---------------------------------------------------------------------------

    \10\ Groups must have at least 25 clinicians to participate in 
Web Interface.
---------------------------------------------------------------------------

    These two factors have financial implications based on the MIPS 
scoring model described in the CY 2018 Quality Payment Program proposed 
rule (82 FR 30233 through 30241). Looking at the combined impact 
performance, we observed consistent trends for small practices in 
various scenarios. A combined impact of performance measurement looks 
at the aggregate net percent change (the combined impact of MIPS 
negative and positive adjustments). The MIPS payment adjustment is 
connected to the final score because final scores below the performance 
threshold receive a negative MIPS payment adjustment and final scores 
above the performance threshold receive a positive MIPS payment 
adjustment. In analyzing the combined impact performance, we see MIPS 
eligible clinicians in small practices consistently have a lower 
combined impact performance than larger practices based on actual 
historical data and after we apply the 80 and 90 percent participation 
assumptions.
    Due to these challenges, we proposed an adjustment to the final 
score for MIPS eligible clinicians in small practices (referred to 
herein as the ``small practice bonus'') to recognize these barriers and 
to incentivize MIPS

[[Page 53777]]

eligible clinicians in small practices to participate in the Quality 
Payment Program and to overcome any performance discrepancy due to 
practice size (82 FR 30139 through 30140). To receive the small 
practice bonus, we proposed that the MIPS eligible clinician must 
participate in the program by submitting data on at least one 
performance category in the 2018 MIPS performance period. Therefore, 
MIPS eligible clinicians would not need to meet submission requirements 
for the quality performance category in order to receive the bonus 
(they could instead submit improvement activities or advancing care 
information measures only or submit fewer than the required number of 
measures for the quality performance category). Additionally, we 
proposed that group practices, virtual groups, or APM Entities that 
consist of a total of 15 or fewer clinicians may receive the small 
practice bonus.
    We proposed at Sec.  414.1380(c)(4) to add a small practice bonus 
of 5 points to the final score for MIPS eligible clinicians who 
participate in MIPS for the 2018 MIPS performance period and are in 
small practices, virtual groups, or APM Entities with 15 or fewer 
clinicians (the entire virtual group or APM Entity combined must 
include 15 or fewer clinicians to qualify for the bonus). We proposed 
in the CY 2018 Quality Payment Program proposed rule that if the result 
of the calculation is greater than 100 points, then the final score 
would be capped at 100 points (82 FR 30140). This bonus is intended to 
be a short-term strategy to help small practices transition to MIPS; 
therefore, we proposed the bonus only for the 2018 MIPS performance 
period (2020 MIPS payment year) and will assess on an annual basis 
whether to continue the bonus and how the bonus should be structured.
    We invited public comment on our proposal to apply a small practice 
bonus for the 2020 MIPS payment year.
    We also considered applying a bonus for MIPS eligible clinicians 
that practice in either a small practice or a rural area. However, on 
average, because we saw less than a 1-point difference between scores 
for MIPS eligible clinicians who practice in rural areas and those who 
do not, we did not propose a bonus for those who practice in a rural 
area, but plan to continue to monitor the Quality Payment Program's 
impacts on the performance of those who practice in rural areas. We 
also sought comment on the application of a rural bonus in the future, 
including available evidence demonstrating differences in clinician 
performance based on rural status. If we implement a bonus for 
practices located in rural areas, we would use the definition for rural 
specified in section II.C.1.d. of this final rule with comment period 
for individuals and groups (including virtual groups).
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters supported the proposed small practice 
bonus for the 2020 MIPS payment year. The commenters expressed the 
belief that this bonus will help address the particular challenges that 
small practices experience in participating in MIPS, including the 
resources needed to create an infrastructure to meet MIPS reporting 
requirements. Several commenters believe that the small practice bonus 
will help to encourage small practices to participate in MIPS. A few 
commenters supported the application of the small practice bonus to 
group practices, virtual groups, and APM Entities.
    Response: We thank commenters for their support. We agree that the 
small practice bonus will help to alleviate the impact of some of the 
particular challenges that small practices experience in participating 
in MIPS on performance, and believe that the bonus will help 
incentivize these practices to participate in MIPS.
    Comment: A few commenters requested that CMS extend the small 
practice bonus to future years of MIPS to maintain stability. One 
commenter requested that CMS reevaluate the small practice bonus in 
future years to ensure that it is sufficient to overcome any 
discrepancies due to practice size.
    Response: We are finalizing the small practice bonus for the 2020 
MIPS payment year only. We intend to continue to evaluate options to 
address challenges small practices face to participate in MIPS in 
future rulemaking, including continuation of the small practice bonus, 
as appropriate.
    Comment: A few commenters expressed the belief that some practices 
may not meet the definition of a small practice due to the use of part-
time, temporary staff that will cause them to exceed the 15-clinician 
threshold. One commenter suggested that CMS revise the definition of a 
small practice to include full-time employees only. One commenter 
requested that CMS expand the small practice bonus to practices of 16 
to 24 clinicians.
    Response: We thank the commenters for alerting us to this potential 
limitation in our definition of a small practice, and we will monitor 
the impact of part-time and temporary staff to determine whether we 
should propose changes to the small practice bonus in future 
rulemaking. However, we also believe it is important to maintain 
consistency within the Quality Payment Program, so we intend to align 
this bonus with our definition of small practices under Sec.  414.1305. 
In addition, we have not seen the same discrepancies in simulated MIPS 
final scores among practices of 16-24 clinicians that we have observed 
for practices of 15 or fewer clinicians.
    Comment: One commenter suggested that CMS reduce the small practice 
bonus to 3 points, instead of 5 points. The commenter expressed the 
belief that the small practice bonus represented too great a proportion 
of the performance threshold (5 points of the proposed 15-point 
performance threshold which represents 30 percent of the points).
    Response: We believe a bonus of 5 points is appropriate to 
acknowledge the challenges small practices face in participating in 
MIPS, and to help them achieve the performance threshold finalized at 
section II.C.8.c. of this final rule with comment period at 15 points 
for the 2020 MIPS payment year, as this bonus represents one-third of 
the total points needed to meet or exceed the performance threshold and 
receive a neutral or positive payment adjustment. With a small practice 
bonus of 5 points, small practices could achieve this performance 
threshold by reporting 3 quality measures or 1 quality measure and 1 
medium weighted improvement activity.\11\
---------------------------------------------------------------------------

    \11\ Assuming the small practice did not submit data for the 
advancing care information performance category and applied for the 
hardship exception and had the advancing care information 
performance category weight redistributed to the quality performance 
category, the small practice would have a final score with 75 
percent weight from the quality performance category score, 15 
percent from improvement activities, and 10 percent from cost. With 
the proposed scoring for small practices, submitting one measure one 
time would provide at least 3 measure achievement points out of 60 
total available measure points. With 75 percent quality performance 
category weight, each quality measure would be worth at least 3.75 
points towards the final score. ((3/60) x 75% x 100 = 3.75 points). 
For improvement activities, each medium weighted activity is worth 
20 out of 40 possible points which translates to 7.5 points to the 
file score. (20/40) x 15% x 100 = 7.5 points). The final score would 
be at least 3.75 points for quality + 7.5 points for improvement 
activities + 5 point small practice bonus which equals 16.5 points 
without considering cost or the complex patient bonus.
---------------------------------------------------------------------------

    Comment: One commenter suggested that CMS require small practices 
to report on at least 2 performance categories in order to receive the 
small practice bonus.
    Response: We continue to believe that it is appropriate to require 
MIPS eligible clinicians to report on only one performance category in 
order to receive the small practice bonus because we

[[Page 53778]]

want to encourage small practices to participate in MIPS and we are 
still in a transition phase. We may reconsider the need for the bonus 
or augment requirements for small practices to receive the small 
practice bonus in future rulemaking.
    Comment: Some commenters did not support the small practice bonus 
as proposed. Some commenters expressed the belief that CMS should 
instead focus on providing technical assistance to small and rural 
practices who may struggle to meet MIPS reporting requirements. One 
commenter suggested that CMS calculate different performance thresholds 
based on practice size. A few commenters expressed the belief that the 
small practice bonus, along with additional available bonuses, may make 
it difficult for other MIPS eligible clinicians to succeed in MIPS and 
earn a positive adjustment. One commenter expressed the belief that 
small practices can be competitive in MIPS by participating in a 
virtual group or reporting quality measures above the minimum number. 
Another commenter expressed the belief that the small practice bonus is 
not sufficient to overcome the disparities small practices face to 
succeed in MIPS.
    Response: We intend to explore other approaches to account for the 
impact of practice size on MIPS performance in future rulemaking as 
well as monitor for any unintended consequences of the bonus in the 
MIPS program, including impact on MIPS eligible clinicians who are not 
in small practices. We are not able to create different performance 
thresholds based on practice size because we believe section 
1848(q)(6)(D) of the Act requires us to establish one performance 
threshold applicable to all MIPS eligible clinicians for a year. We 
believe that technical support is critical for the success of small 
practices in reporting for MIPS, but we also believe that a bonus is 
appropriate at this time due to the discrepancies in performance we 
observed for clinicians in small practices as compared with clinicians 
in practices with 100 or more clinicians. We have launched the Small, 
Underserved, and Rural Support initiative, a 5-year program, to provide 
technical support to MIPS eligible clinicians in small practices. The 
program provides assistance to practices in selecting and reporting on 
quality measures, education and outreach, and support for optimizing 
health information technology.
    Comment: Several commenters requested that CMS implement a similar 
bonus for rural practices. The commenters noted that not all rural 
practices meet the definition of a small practice, but these practices 
face unique challenges in meeting MIPS reporting requirements. For 
example, the commenters expressed the belief that rural practices face 
particular challenges in adopting health information technology. 
Commenters further noted that rural practices lack resources to help 
achieve high performance on quality measures. One commenter expressed 
the belief that relying on data from preceding programs such as PQRS 
and the VM to estimate the impact of rural status on performance may 
provide an incomplete picture due to low participation rates for rural 
practices in these legacy programs. One commenter expressed the belief 
that a rural practice bonus may signal that quality standards for 
patients in rural areas do not need to be as high as those for patients 
in non-rural areas.
    Response: As we discussed in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30140), we observed that performance for rural 
MIPS eligible clinicians is very similar to performance for non-rural 
MIPS eligible clinician once we account for practice size, so we do not 
believe a bonus for MIPS eligible clinicians practicing in a rural 
setting is appropriate at this time. We acknowledge that legacy program 
data may not provide a complete picture of MIPS participation rates for 
practices located in rural areas. We will continue to monitor impacts 
of rural status on performance in the MIPS program and if warranted, 
propose adjustments through future rulemaking.
    Final Action: After consideration of the public comments, we are 
finalizing at Sec.  414.1380(c)(4) our proposal to add a small practice 
bonus of 5 points to the final score for MIPS eligible clinicians, 
groups, APM Entities, and virtual groups that meet the definition of a 
small practice as defined at Sec.  414.1305 and submit data on at least 
one performance category in the 2018 performance period.
    We seek comment on approaches to better align final score and 
performance category level bonuses for simplicity in future rulemaking.
(2) Final Score Calculation
    We proposed a formula for the final score calculation for MIPS 
eligible clinicians, groups, virtual groups, and APM Entities at Sec.  
414.1380(c), which includes the proposed complex patient and small 
practice bonuses. We also proposed to revise the policy finalized in 
the CY 2017 Quality Payment Program final rule to assign MIPS eligible 
clinicians with only 1 scored performance category a final score that 
is equal to the performance threshold (81 FR 77326 through 77328) (we 
noted that we inadvertently failed to codify this policy in Sec.  
414.1380(c)). We proposed this revision to the policy to account for 
our proposal in the CY 2018 Quality Payment Program proposed rule (82 
FR 30144 through 30146) for extreme and uncontrollable circumstances 
which, if finalized, could result in a scenario where a MIPS eligible 
clinician is not scored on any performance categories. To reflect this 
proposal, we proposed to add to Sec.  414.1380(c) that a MIPS eligible 
clinician with fewer than 2 performance category scores would receive a 
final score equal to the performance threshold.
    With the proposed addition of the complex patient and small 
practice bonuses, we also proposed to strike the following phrase from 
the final score definition at Sec.  414.1305: ``The final score is the 
sum of each of the products of each performance category score and each 
performance category's assigned weight, multiplied by 100.'' We 
believed this portion of the definition would be incorrect and 
redundant of the proposed revised regulation at Sec.  414.1380(c).
    We requested public comment on the proposed final score methodology 
and associated revisions to regulation text.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter supported the proposal for MIPS eligible 
clinicians who are scored on fewer than two performance categories to 
receive a final score equal to the performance threshold.
    Response: We thank the commenter for their support of our proposal.
    Comment: Several commenters expressed the belief that calculation 
of the final score is overly confusing for MIPS eligible clinicians. A 
few commenters suggested that CMS modify our scoring methodology so 
that performance category points are equal to points in the final 
score. This would mean that, for example, the advancing care 
information performance category total possible points would be 25 
points which would be equal to the generally applicable weighting for 
the advancing care information performance category of 25 points.
    Response: Simplification in scoring is a core goal of the MIPS 
program so that MIPS eligible clinicians can easily understand how the 
final score is calculated. In determining scoring policies for the MIPS 
program, we kept this goal in mind whenever possible. The weighting of 
performance categories can vary for different MIPS eligible

[[Page 53779]]

clinicians, such as when there are not sufficient measures or 
activities applicable and available to a clinician, and the performance 
categories are reweighted in their final score. For example, non-
patient facing MIPS eligible clinicians can qualify for reweighting of 
the advancing care information performance category. If a non-patient 
facing MIPS eligible clinician does not submit advancing care 
information data, then the advancing care information performance 
category score would be redistributed to the quality performance 
category and non-patient facing MIPS eligible clinician would have a 75 
percent weighting for quality instead of 50 percent (see Table 28 of 
this final rule with comment period for the different potential 
redistribution combinations). Therefore, it is not possible to have a 
single scoring system that generates the exact number of points toward 
the final score. Instead, we have created a system where a clinician 
receives a performance category score and then that score is multiplied 
by the weight assigned to the performance category. We intend to 
continue to explore approaches to simplify MIPS scoring in future 
rulemaking.
    In the meantime, we seek comment on approaches to display scores 
and provide feedback to MIPS eligible clinicians in a way that MIPS 
eligible clinicians can easily understand how their scores are 
calculated, including how performance category scores are translated to 
a final score. We also seek comment on how to simplify the scoring 
system while still recognizing differences in clinician practices.
    Final Action: After consideration of public comments, we are 
finalizing the revisions to Sec.  414.1380(c) and Sec.  414.1305 as 
proposed.
(3) Final Score Performance Category Weights
(a) General Weights
    Section 1848(q)(5)(E)(i) of the Act specifies weights for the 
performance categories included in the MIPS final score: In general, 30 
percent for the quality performance category, 30 percent for the cost 
performance category, 25 percent for the advancing care information 
performance category, and 15 percent for the improvement activities 
performance category. However, that section also specifies different 
weightings for the quality and cost performance categories for the 
first and second years for which the MIPS applies to payments. Section 
1848(q)(5)(E)(i)(II)(bb) of the Act specifies that for the transition 
year, not more than 10 percent of the final score will be based on the 
cost performance category, and for the 2020 MIPS payment year, not more 
than 15 percent will be based on the cost performance category. Under 
section 1848(q)(5)(E)(i)(I)(bb) of the Act, the weight of the quality 
performance category for each of the first 2 years will increase by the 
difference of 30 percent minus the weight specified for the cost 
performance category for the year.
    In the CY 2017 Quality Payment Program final rule, we established 
the weights of the cost performance category as 10 percent of the final 
score (81 FR 77166) and the quality performance category as 50 percent 
of the final score (81 FR 77100) for the 2020 MIPS payment year. While 
we proposed in the CY 2018 Quality Payment Program proposed rule (82 FR 
30047 through 30048) to change the weight of the cost performance 
category to zero percent and to change the weight of the quality 
performance category to 60 percent for the 2020 MIPS payment year, we 
are finalizing a weight of 10 percent for cost for the 2020 MIPS 
payment year, so the quality performance category weight will be 50 
percent (82 FR 30037 through 30038). We refer readers to sections 
II.C.6.b. and II.C.6.d. of this final rule with comment period for 
further information on the final policies related to the weight of the 
quality and cost performance categories, including our rationale for 
our weighting for each category.
    As specified in section 1848(q)(5)(E)(i) of the Act, the weights 
for the other performance categories are 25 percent for the advancing 
care information performance category and 15 percent for the 
improvement activities performance category. Section 1848(q)(5)(E)(ii) 
of the Act provides that in any year in which the Secretary estimates 
that the proportion of eligible professionals (as defined in section 
1848(o)(5) of the Act) who are meaningful EHR users (as determined in 
section 1848(o)(2) of the Act) is 75 percent or greater, the Secretary 
may reduce the applicable percentage weight of the advancing care 
information performance category in the final score, but not below 15 
percent. For more on our policies concerning section 1848(q)(5)(E)(ii) 
of the Act and a review of our proposal for reweighting the advancing 
care information performance category in the event that the proportion 
of MIPS eligible clinicians who are meaningful EHR users is 75 percent 
or greater starting with the 2019 MIPS performance period, we refer 
readers to section II.C.6.f.(5) of this final rule with comment period.
    Table 28 summarizes the weights specified for each performance 
category.

                                 Table 28--Weights by MIPS Performance Category
----------------------------------------------------------------------------------------------------------------
                                                                                     2020 MIPS       2021 MIPS
                      Performance category                          Transition     payment year    payment year
                                                                     year (%)           (%)       and beyond (%)
----------------------------------------------------------------------------------------------------------------
Quality.........................................................              60              50              30
Cost............................................................               0              10              30
Improvement Activities..........................................              15              15              15
Advancing Care Information*.....................................              25              25              25
----------------------------------------------------------------------------------------------------------------
* As described in section II.C.6.f.(5) of this final rule with comment period, the weight for advancing care
  information could decrease (not below 15 percent) starting with the 2021 MIPS payment year if the Secretary
  estimates that the proportion of physicians who are meaningful EHR users is 75 percent or greater.

(b) Flexibility for Weighting Performance Categories
    Under section 1848(q)(5)(F) of the Act, if there are not sufficient 
measures and activities applicable and available to each type of MIPS 
eligible clinician involved, the Secretary shall assign different 
scoring weights (including a weight of zero) for each performance 
category based on the extent to which the category is applicable and 
for each measure and activity based on the extent to which the measure 
or activity is applicable and available to the type of MIPS eligible 
clinician involved. For the 2020 MIPS payment year, we proposed to 
assign a scoring weight of zero percent to a performance category

[[Page 53780]]

and redistribute its weight to the other performance categories in the 
following scenarios.
    For the quality performance category, we proposed that having 
sufficient measures applicable and available means that we can 
calculate a quality performance category percent score for the MIPS 
eligible clinician because at least one quality measure is applicable 
and available to the MIPS eligible clinician. Based on the volume of 
measures available to MIPS eligible clinicians via the multiple 
submission mechanisms, we stated that we generally believe there will 
be at least 1 quality measure applicable and available to every MIPS 
eligible clinician. If we receive no quality performance category 
submission from a MIPS eligible clinician, the MIPS eligible clinician 
generally will receive a performance category score of zero (or 
slightly above zero if the all-cause hospital readmission measure 
applies because the clinician submits data for a performance category 
other than the quality performance category).\12\ However, as described 
in the CY 2018 Quality Payment Program proposed rule (82 FR 30108 
through 30109), there may be rare instances that we believe could 
affect only a very limited subset of MIPS eligible clinicians (as well 
as groups and virtual groups) that may have no quality measures 
available and applicable and for whom we receive no quality performance 
category submission (and for whom the all-cause hospital readmission 
measure does not apply). In those instances, we would not be able to 
calculate a quality performance category percent score.
---------------------------------------------------------------------------

    \12\ As discussed in the CY 2017 Quality Payment Program final 
rule (81 FR 77300), groups of 16 or more eligible clinicians that 
meet the applicable case minimum requirement are automatically 
scored on the all-cause readmission measure, even if they do not 
submit any other data under the quality performance category, 
provided that they submit data under one of the other performance 
categories. If such groups do not submit data under any performance 
category, the readmission measure is not scored.
---------------------------------------------------------------------------

    The proposed quality performance category scoring policies for the 
2020 MIPS payment year continue many of the special scoring policies 
from the transition year which would enable us to determine a quality 
performance category percent score whenever a MIPS eligible clinician 
has submitted at least 1 quality measure. In addition, MIPS eligible 
clinicians that do not submit quality measures when they have them 
available and applicable would receive a quality performance category 
percent score of zero percent. It is only in the rare scenarios when we 
determine that a MIPS eligible clinician does not have any relevant 
quality measures available to report or the MIPS eligible clinician is 
approved for reweighting the quality performance category based on 
extreme and uncontrollable circumstances as proposed in the CY 2018 
Quality Payment Program proposed rule (82 FR 30142 through 30144), that 
we would reweight the quality performance category.
    For the cost performance category, we stated that we continue to 
believe that having sufficient measures applicable and available means 
that we can reliably calculate a score for the cost measures that 
adequately captures and reflects the performance of a MIPS eligible 
clinician, and that MIPS eligible clinicians who are not attributed 
enough cases to be reliably measured should not be scored for the cost 
performance category (82 FR 30142). We established a policy in the CY 
2017 Quality Payment Program final rule that if a MIPS eligible 
clinician is not attributed enough cases for a measure (in other words, 
has not met the required case minimum for the measure), or if a measure 
does not have a benchmark, then the measure will not be scored for that 
clinician (81 FR 77323). If we do not score any cost measures for a 
MIPS eligible clinician in accordance with this policy, then the 
clinician would not receive a cost performance category percent score. 
Because we proposed in the CY 2018 Quality Payment Program proposed 
rule to set the weight of the cost performance category to zero percent 
of the final score for the 2020 MIPS payment year, we did not propose 
to redistribute the weight of the cost performance category to any 
other performance categories for the 2020 MIPS payment year. In the 
event we did not finalize this proposal, we proposed to redistribute 
the weight of the cost performance category as described in the CY 2018 
Quality Payment Program proposed rule (82 FR 30144 through 30146).
    For the improvement activities performance category, we stated the 
belief that all MIPS eligible clinicians will have sufficient 
activities applicable and available; however, as discussed in the CY 
2018 Quality Payment Program proposed rule (82 FR 30142 through 30144), 
we believe there are limited extreme and uncontrollable circumstances, 
such as natural disasters, where a clinician is unable to report 
improvement activities. Barring these circumstances, we did not propose 
any changes that would affect our ability to calculate an improvement 
activities performance category score.
    We refer readers to the CY 2018 Quality Payment Program proposed 
rule (82 FR 30075 through 30079) for a detailed discussion of our 
proposals and policies under which we would not score the advancing 
care information performance category and would assign a weight of zero 
percent to that category for a MIPS eligible clinician.
    We invited public comment on our interpretation of sufficient 
measures available and applicable in the performance categories.
    Final Action: We did not receive any comments. We are finalizing 
our proposed policies for our interpretation of measures available and 
applicable for the quality, cost, and improvement activities for the 
2020 MIPS payment year.
(c) Extreme and Uncontrollable Circumstances
    In the CY 2017 Quality Payment Program final rule (81 FR 77241 
through 77243), we discussed our belief that extreme and uncontrollable 
circumstances, such as a natural disaster in which an EHR or practice 
location is destroyed, can happen at any time and are outside a MIPS 
eligible clinician's control. We stated that if a MIPS eligible 
clinician's CEHRT is unavailable as a result of such circumstances, 
then the measures specified for the advancing care information 
performance category may not be available for the MIPS eligible 
clinician to report. We established a policy allowing a MIPS eligible 
clinician affected by extreme and uncontrollable circumstances to 
submit an application to us to be considered for reweighting of the 
advancing care information performance category under section 
1848(q)(5)(F) of the Act. Although we proposed (82 FR 30075 through 
30078) to use the authority in the last sentence of section 
1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 
21st Century Cures Act, as the authority for this policy, rather than 
section 1848(q)(5)(F) of the Act, we continue to believe that extreme 
and uncontrollable circumstances could affect the availability of a 
MIPS eligible clinician's CEHRT and the measures specified for the 
advancing care information performance category.
    While we had not adopted a similar reweighting policy for the other 
performance categories in the transition year, we stated that we 
believe a similar reweighting policy may be appropriate for the 
quality, cost, and improvement activities performance categories 
beginning with the 2020 MIPS payment year (82 FR 30142). For these 
performance categories, we proposed to define ``extreme and 
uncontrollable circumstances'' as rare (that is, highly

[[Page 53781]]

unlikely to occur in a given year) events entirely outside the control 
of the clinician and of the facility in which the clinician practices 
that cause the MIPS eligible clinician to not be able to collect 
information that the clinician would submit for a performance category 
or to submit information that would be used to score a performance 
category for an extended period of time (for example, 3 months could be 
considered an extended period of time with regard to information a 
clinician would collect for the quality performance category). For 
example, a tornado or fire destroying the only facility in which a 
clinician practices likely would be considered an ``extreme and 
uncontrollable circumstance;'' however, neither the inability to renew 
a lease--even a long or extended lease--nor a facility being found not 
compliant with federal, state, or local building codes or other 
requirements would be considered ``extreme and uncontrollable 
circumstances''. We proposed that we would review both the 
circumstances and the timing independently to assess the availability 
and applicability of measures and activities independently for each 
performance category. For example, in 2018 the performance period for 
improvement activities is only 90 days, whereas it is 12 months for the 
quality performance category, so an issue lasting 3 months may have 
more impact on the availability of measures for the quality performance 
category than for the improvement activities performance category, 
because the MIPS eligible clinician, conceivably, could participate in 
improvement activities for a different 90-day period.
    We stated that we believe that extreme and uncontrollable 
circumstances, such as natural disasters, may affect a clinician's 
ability to access or submit quality measures via all submission 
mechanisms (effectively rendering the measures unavailable to the 
clinician), as well as the availability of numerous improvement 
activities. In addition, damage to a facility where care is provided 
due to a natural disaster, such as a hurricane, could result in 
practice management and clinical systems that are used for the 
collection or submission of data to be down, thus impacting a 
clinician's ability to submit necessary information via Qualified 
Registry, QCDR, CMS Web Interface, or claims. This policy would not 
include issues that third-party intermediaries, such as EHRs, Qualified 
Registries, or QCDRs, might have submitting information to MIPS on 
behalf of a MIPS eligible clinician. Instead, this policy is geared 
towards events, such as natural disasters, that affect the MIPS 
eligible clinician's ability to submit data to the third-party 
intermediary, which in turn, could affect the ability of the clinician 
(or the third-party intermediary acting on their behalf) to 
successfully submit measures and activities to MIPS.
    We also proposed to use this policy for measures which we derive 
from claims data, such as the all-cause hospital readmission measure 
and the cost measures. Other programs, such as the Hospital VBP 
Program, allow hospitals to submit exception applications when ``a 
hospital is able to continue to report data on measures . . . but can 
demonstrate that its Hospital VBP Program measure rates are negatively 
impacted as a result of a natural disaster or other extraordinary 
circumstance and, as a result, the hospital receives a lower value-
based incentive payment'' (78 FR 50705). For the Hospital VBP Program, 
we ``interpret[ed] the minimum numbers of cases and measures 
requirement in the Act to enable us to not score . . . all applicable 
quality measure data from a performance period and, thus, exclude the 
hospital from the Hospital VBP Program for a fiscal year during which 
the hospital has experienced a disaster or other extraordinary 
circumstance'' (78 FR 50705). Hospitals that request and are granted an 
exception are exempted from the Program entirely for the applicable 
year.
    For the 2020 MIPS payment year, we would score quality measures and 
assign points even for those clinicians who do not meet the case 
minimums for the quality measures they submit. However, we established 
a policy not to score a cost measure unless a MIPS eligible clinician 
has met the required case minimum for the measure (81 FR 77323), and 
not to score administrative claims measures, such as the all-cause 
hospital readmission measure, if they cannot be reliably scored against 
a benchmark (81 FR 77288 through 77289). Even if the required case 
minimums have been met and we are able to reliably calculate scores for 
the measures that are derived from claims, we believe a MIPS eligible 
clinician's performance on those measures could be adversely impacted 
by a natural disaster or other extraordinary circumstance, similar to 
the issues we identified for the Hospital VBP Program. For example, the 
claims data used to calculate the cost measures or the all-cause 
hospital readmission measure could be significantly affected if a 
natural disaster caused wide-spread injury or health problems for the 
community, which could not have been prevented by high-value 
healthcare. In such cases, we believe that the measures are available 
to the clinician, but are likely not applicable, because the extreme 
and uncontrollable circumstance has disrupted practice and measurement 
processes. Therefore, we believed an approach similar to that in the 
Hospital VBP Program (78 FR 50705) is warranted under MIPS, and we 
proposed that we would exempt a MIPS eligible clinician from all 
quality and cost measures calculated from administrative claims data if 
the clinician is granted an exception for the respective performance 
categories based on extreme and uncontrollable circumstances.
    Beginning with the 2020 MIPS payment year, we proposed that we 
would reweight the quality, cost, and/or improvement activities 
performance categories if a MIPS eligible clinician, group, or virtual 
group's request for a reweighting assessment based on extreme and 
uncontrollable circumstances is granted. We proposed that MIPS eligible 
clinicians could request a reweighting assessment if they believe 
extreme and uncontrollable circumstances affect the availability and 
applicability of measures for the quality, cost, and improvement 
activities performance categories. To the extent possible, we noted we 
would seek to align the requirements for submitting a reweighting 
assessment for extreme and uncontrollable circumstances with the 
requirements for requesting a significant hardship exception for the 
advancing care information performance category. For example, we 
proposed to adopt the same deadline (December 31, 2018 for the 2018 
MIPS performance period) for submission of a reweighting assessment 
(see 82 FR 30075 through 30078), and we encouraged the requests to be 
submitted on a rolling basis. We proposed the reweighting assessment 
must include the nature of the extreme and uncontrollable circumstance, 
including the type of event, date of the event, and length of time over 
which the event took place, performance categories impacted, and other 
pertinent details that impacted the ability to report on measures or 
activities to be considered for reweighting of the quality, cost, or 
improvement activities performance categories (for example, information 
detailing how exactly the event impacted availability and applicability 
of measures). We stated that if we finalize the policy to allow 
reweighting based on extreme and uncontrollable circumstances beginning 
with the 2020 MIPS payment year, we would specify the form and manner 
in which these reweighting applications must be

[[Page 53782]]

submitted outside of the rulemaking process after the final rule is 
published.
    For virtual groups, we proposed to request that virtual groups 
submit a reweighting assessment for extreme and uncontrollable 
circumstances similar to groups, and we would evaluate whether 
sufficient measures and activities are applicable and available to the 
majority of TINs in the virtual group. We proposed that a majority of 
TINs in the virtual group would need to be impacted before we grant an 
exception. We still found it important to measure the performance of 
virtual group members unaffected by an extreme and uncontrollable 
circumstance even if some of the virtual group's TINs are affected.
    We also sought comment on what additional factors we should 
consider for virtual groups. We proposed that the reweighting 
assessment due to extreme and uncontrollable circumstances for the 
quality, cost, and improvement activities would not be available to APM 
Entities in the APM scoring standard for the following reasons. First, 
all MIPS eligible clinicians scored under the APM scoring standard will 
automatically receive an improvement activities category score based on 
the terms of their participation in a MIPS APM and need not report 
anything for this performance category. Second, the cost performance 
category has no weight under the APM scoring standard. Finally, for the 
quality performance category, each MIPS APM has its own rules related 
to quality measures and we believe any decisions related to 
availability and applicability of measures should reside within the 
model. As noted in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30087 through 30088), APM entities in MIPS APMs would be able to 
request reweighting of the advancing care information performance 
category.
    We noted that if we finalize these proposals for reweighting the 
quality, cost, and improvement activities performance categories based 
on extreme and uncontrollable circumstances, then it would be possible 
that one or more of these performance categories would not be scored 
and would be weighted at zero percent of the final score for a MIPS 
eligible clinician. We proposed to assign a final score equal to the 
performance threshold if fewer than 2 performance categories are scored 
for a MIPS eligible clinician. This is consistent with our policy 
finalized in the CY 2017 Quality Payment Program final rule that 
because the final score is a composite score, we believe the intention 
of section 1848(q)(5) of the Act is for MIPS eligible clinicians to be 
scored based on multiple performance categories (81 FR 77326 through 
77328).
    We requested comment on our extreme and uncontrollable 
circumstances proposals. We also sought comment on the types of the 
extreme and uncontrollable circumstances we should consider for this 
policy given the general parameters we describe in this section.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters supported our proposal to reweight the 
performance categories based on extreme and uncontrollable 
circumstances. These commenters stated that MIPS eligible clinicians 
who experience extreme and uncontrollable events are already 
significantly burdened and should not be subject to MIPS reporting 
requirements. A few commenters stated that claims data could be 
impacted by extreme and uncontrollable events.
    Response: We thank commenters for their support of our proposed 
policy to reweight the performance categories in the event of extreme 
and uncontrollable circumstances.
    Comment: One commenter requested that CMS modify our proposal to 
allow MIPS eligible clinicians who are eligible for an improvement 
score to receive the improvement score points, believing that this will 
provide recognition of improvement.
    Response: Because MIPS eligible clinicians would not report or 
receive a score for the quality and cost performance categories if 
those categories are reweighted based on extreme and uncontrollable 
circumstances, we would not have data sufficient to measure improvement 
for the current or future performance periods. We refer readers to 
sections II.C.7.a.(2)(i) and II.C.7.a.(3)(a) of this final rule with 
comment period for a summary of our policies related to data 
sufficiency. We believe it is important to measure improvement for as 
many MIPS eligible clinicians as possible, and we seek comment on ways 
we can modify our improvement scoring policies to account for 
clinicians who have been affected by extreme and uncontrollable 
circumstances. For example, in cases where sufficient data from the 
prior performance period are not available to measure improvement due 
to extreme and uncontrollable circumstances, should we use data from 2 
years prior to the performance period if such data is available.
    Comment: A few commenters suggested additional types of events to 
include in the definition of extreme and uncontrollable circumstances. 
A few commenters requested that CMS include extreme and uncontrollable 
events caused by a third-party intermediary submitting information to 
CMS on behalf of a MIPS eligible clinician. In addition, a few 
commenters requested that CMS include physician illness and maternity 
leave in the definition of extreme and uncontrollable events.
    Response: We continue to believe it is appropriate to maintain a 
narrow definition of extreme and uncontrollable circumstances for the 
quality, cost, and improvement activities performance categories. For 
third-party intermediaries, we believe it more appropriate to monitor 
the third-party issues and take additional action if needed in the 
future rather than address it through the extreme and uncontrollable 
circumstances policy here at this time. We refer readers to section 
II.C.10. in this final rule with comment period for additional 
information on third party vendors. We believe many clinicians affected 
by illness or who are on maternity leave would be excluded from MIPS 
due to not exceeding the low-volume threshold; however, we will review 
each application on a case-by-case basis and determine whether 
reweighting is warranted based on the circumstances described and 
information provided.
    Comment: One commenter requested that CMS allow flexibility in our 
process for reviewing reweighting applications because they believe 
certain events may impact certain MIPS eligible clinicians more than 
others.
    Response: We intend for the review process to be flexible and take 
into consideration various factors, including the duration, type, and 
severity of the circumstances. We agree with commenters that additional 
flexibility is appropriate, especially for virtual groups because we 
have finalized the virtual group reporting option to support MIPS 
eligible clinicians who may have a difficult time reporting in MIPS 
individually. We believe that there may be cases where less than a 
majority of the TINs in a virtual group are impacted by an extreme and 
uncontrollable event, but reweighting is still appropriate. For 
example, there may be one TIN in the virtual group which is impacted by 
an extreme and uncontrollable event; however, that TIN may be the one 
coordinating data collection and submission for the entire virtual 
group. Conversely, we believe there may be cases where more than a 
majority of the TINs in a virtual group are impacted by an extreme and 
uncontrollable event, but reweighting

[[Page 53783]]

may still not be appropriate. One example may be when the TINs impacted 
by the event experience the event; however, the event did not impede 
data collection. As a result, we are not finalizing the proposal that a 
majority of TINs in the virtual group would need to be impacted by 
extreme and uncontrollable circumstances in order for the virtual group 
to qualify for reweighting.
    Final Action: After consideration of the public comments, we are 
finalizing the proposed policies for reweighting the quality, cost, and 
improvement activities performance categories based on extreme and 
uncontrollable circumstances, beginning with the 2018 performance 
period/2020 MIPS payment year with one minor exception. We are not 
finalizing the proposal that a virtual group submitting a reweighting 
application must have a majority of its TINs impacted by extreme and 
uncontrollable circumstances in order for the virtual group to qualify 
for reweighting, but instead we will review each virtual group 
application on a case-by-case basis and make a determination based on 
the information provided on the practices impacted and nature of the 
event. As we noted in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30143), we will specify the form and manner in which the 
reweighting applications must be submitted outside of the rulemaking 
process after this final rule with comment period is published. We also 
invite public comment on alternatives to these policies, such as using 
a shortened performance period, which may allow us to measure 
performance, rather than reweighting the performance categories to zero 
percent.
    These policies for reweighting the quality, cost, and improvement 
activities performance categories based on extreme and uncontrollable 
circumstances will apply beginning with the 2018 MIPS performance 
period/2020 MIPS payment year. We recognize, however, that MIPS 
eligible clinicians have been affected by the recent hurricanes Harvey, 
Irma, and Maria, which affected large regions of the United States in 
August and September of 2017. We are adopting interim final policies 
for the 2017 performance period/2019 MIPS payment year for MIPS 
eligible clinicians who have been affected by these hurricanes and 
other natural disasters and refer readers to the interim final rule 
with comment period in section III.B.
(d) Redistributing Performance Category Weights
    In the CY 2017 Quality Payment Program final rule, we codified at 
Sec.  414.1380(c)(2) that we will assign different scoring weights for 
the performance categories if we determine there are not sufficient 
measures and activities applicable and available to MIPS eligible 
clinicians (81 FR 77327). We also finalized a policy to assign MIPS 
eligible clinicians with only one scored performance category a final 
score that is equal to the performance threshold, which means the 
clinician would receive a MIPS payment adjustment factor of zero 
percent for the year (81 FR 77326 through 77328). We proposed in the CY 
2018 Quality Payment Program proposed rule (82 FR 30140) to refine this 
policy such that a MIPS eligible clinician with fewer than 2 
performance category scores would receive a final score equal to the 
performance threshold. This refinement is to account for the proposal 
in the CY 2018 Quality Payment Program proposed rule (82 FR 30142 
through 30144) for extreme and uncontrollable circumstances, which 
could result in a scenario where a MIPS eligible clinician is not 
scored on any performance categories. We referred readers to the CY 
2017 Quality Payment Program final rule for a description of our 
policies for redistributing the weights of the performance categories 
(81 FR 77325 through 77329). For the 2020 MIPS payment year, we 
proposed to redistribute the weights of the performance categories in a 
manner that is similar to the transition year. However, we also 
proposed new scoring policies to incorporate our proposals for extreme 
and uncontrollable circumstances.
    In the CY 2018 Quality Payment Program proposed rule, (82 FR 30075 
through 30078) we proposed to use the authority in the last sentence of 
section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) 
of the 21st Century Cures Act, as the authority for certain policies 
under which we would assign a scoring weight of zero percent for the 
advancing care information performance category, and to amend Sec.  
414.1380(c)(2) to reflect the proposals. We did not, however, propose 
substantive changes to the policy established in the CY 2017 Quality 
Payment Program final rule to redistribute the weight of the advancing 
care information performance category to the other performance 
categories for the transition year (81 FR 77325 through 77329).
    For the 2020 MIPS payment year, if we assign a weight of zero 
percent for the advancing care information performance category for a 
MIPS eligible clinician, we proposed (82 FR 30144) to continue our 
policy from the transition year and redistribute the weight of the 
advancing care information performance category to the quality 
performance category (assuming the quality performance category does 
not qualify for reweighting). We believe redistributing the weight of 
the advancing care information performance category to the quality 
performance category (rather than redistributing to both the quality 
and improvement activities performance categories) is appropriate 
because MIPS eligible clinicians have more experience reporting quality 
measures through the PQRS program, and measurement in this performance 
category is more mature.
    We noted in the CY 2018 Quality Payment Program proposed rule (82 
FR 30144) that if we do not finalize our proposal to weight the cost 
performance category at zero percent (which means the weight of the 
cost performance category is greater than zero percent), then we would 
not redistribute the weight of any other performance categories to the 
cost performance category. We believed this would be consistent with 
our policy of introducing cost measurement in a deliberate fashion and 
recognition that clinicians are more familiar with other elements of 
MIPS. In the rare and unlikely scenario where a MIPS eligible clinician 
qualifies for reweighting of the quality performance category percent 
score (because there are not sufficient quality measures applicable and 
available to the clinician or the clinician is facing extreme and 
uncontrollable circumstances) and the MIPS eligible clinician is 
eligible to have the advancing care information performance category 
reweighted to zero and the MIPS eligible clinician has sufficient cost 
measures applicable and available to have a cost performance category 
percent score that is not reweighted, then we would redistribute the 
weight of the quality and advancing care information performance 
categories to the improvement activities performance category and would 
not redistribute the weight to the cost performance category. We also 
proposed that if we finalize the cost performance category weight at 
zero percent for the 2020 MIPS payment year, then we would set the 
final score at the performance threshold because the final score would 
be based on the improvement activities performance category which would 
not be a

[[Page 53784]]

composite of 2 or more performance category scores.
    For the 2020 MIPS payment year, we proposed to redistribute the 
weight of the cost performance category to the quality performance 
category if we did not finalize the proposal to set the cost 
performance category at a zero percent weight, and if a MIPS eligible 
clinician does not receive a cost performance category percent score 
because there are not sufficient cost measures applicable and available 
to the clinician or the clinician is facing extreme and uncontrollable 
circumstances. In the rare scenarios where a MIPS eligible clinician 
does not receive a quality performance category percent score because 
there are not sufficient quality measures applicable and available to 
the clinician or the clinician is facing extreme and uncontrollable 
circumstances, we proposed to redistribute the weight of the cost 
performance category equally to the remaining performance categories 
that are not reweighted.
    In the rare event a MIPS eligible clinician is not scored on at 
least one measure in the quality performance category because there are 
not sufficient measures applicable and available or the clinician is 
facing extreme and uncontrollable circumstances, we proposed for the 
2020 MIPS payment year to continue our policy from the transition year 
and redistribute the 60 percent weight of the quality performance 
category so that the performance category weights are 50 percent for 
the advancing care information performance category and 50 percent for 
the improvement activities performance category (assuming these 
performance categories do not qualify for reweighting). While 
clinicians have more experience reporting advancing care information 
measures, we believe equal weighting to both the improvement activities 
and advancing care information performance categories is appropriate 
for simplicity. Additionally, in the absence of quality measures, we 
believe increasing the relative weight of the improvement activities 
performance category is appropriate because both the improvement 
activities and advancing care information performance categories have 
elements of quality and care improvement which are important to 
emphasize. Should the cost performance category have available and 
applicable measures and the cost performance category weight is not 
zero, but either the improvement activities or advancing care 
information performance category is reweighted to zero percent, then we 
proposed that we would redistribute the weight of the quality 
performance category to the remaining performance category that is not 
weighted at zero percent. We would not redistribute the weight to the 
cost performance category.
    We believe that all MIPS eligible clinicians will have sufficient 
improvement activities applicable and available. It is possible that a 
MIPS eligible clinician might face extreme and uncontrollable 
circumstances that render the improvement activities not applicable or 
available to the clinician; however, in that scenario, we believe it is 
likely that the measures specified for the other performance categories 
also would not be applicable or available to the clinician based on the 
circumstances. In the rare event that the improvement activities 
performance category would qualify for reweighting based on extreme and 
uncontrollable circumstances, and the other performance categories 
would not also qualify for reweighting, we proposed to redistribute the 
improvement activities performance category weight to the quality 
performance category consistent with the redistribution policies for 
the cost and advancing care information performance categories. We 
noted in the CY 2018 Quality Payment Program proposed rule (82 FR 
30145) that, should the cost performance category have available and 
applicable measures and the cost performance category weight is not 
finalized at zero percent, and the quality performance category is 
reweighted to zero percent, then we would redistribute the weight of 
the improvement activities performance category to the advancing care 
information performance category. Table 38 in the CY 2018 Quality 
Payment Program proposed rule summarized the potential reweighting 
scenarios based on our proposals for the 2020 MIPS payment year should 
the cost performance category be weighted at zero percent (82 FR 
30145).
    We also considered an alternative approach for the 2020 MIPS 
payment year to redistribute the weight of the advancing care 
information performance category to the quality and improvement 
activities performance categories, to minimize the impact of the 
quality performance category on the final score. For this approach, we 
proposed to redistribute 15 percent to the quality performance category 
(60 percent + 15 percent = 75 percent) and 10 percent to the 
improvement activities performance category (15 percent + 10 percent = 
25 percent). We considered redistributing the weight of the advancing 
care information performance category equally to the quality and 
improvement activities performance categories. However, for simplicity, 
we wanted to redistribute the weights in increments of 5 points. 
Because MIPS eligible clinicians have more experience reporting quality 
measures and because these measures are more mature, under this 
alternative option, we would redistribute slightly more to the quality 
performance category (15 percent vs. 10 percent). Should the cost 
performance category have available and applicable measures and the 
cost performance category weight is not finalized at zero percent and 
the quality performance category is reweighted to zero percent, then we 
would redistribute the weight of the advancing care information 
performance category to the improvement activities performance 
category. This alternative approach, which assumed a cost performance 
category weight of zero percent was detailed in Table 39 of the CY 2018 
Quality Payment Program proposed rule (82 FR 30146).
    We invited comments on our proposal for reweighting the performance 
categories for the 2020 MIPS payment year and our alternative option 
for reweighting the advancing care information performance category.
    The following is a summary of the public comments received and our 
responses:
    Comment: Several commenters supported CMS's proposed reweighting 
policies for the 2020 MIPS payment year. Commenters noted that CMS's 
reweighting policies would alleviate burdens for small and rural 
practices. Some commenters expressed the belief that reweighting to the 
quality performance category was appropriate because it is the category 
with which MIPS eligible clinicians are most familiar.
    Response: We thank commenters for their support of our proposed 
reweighting policies. We are finalizing our reweighting policies as 
proposed for the 2020 MIPS payment year, with the exception of the 
policies that assume the cost performance category will be weighted at 
zero percent in the final score as proposed, because we have decided to 
finalize the cost performance category weight at 10 percent in section 
II.C.6.d.(2) of this final rule with comment period. We agree that 
quality is the performance category with which MIPS eligible clinicians 
are most familiar (compared with the improvement activities performance 
category). The commenters did not specify how this policy would benefit 
small and rural practices, but we agree that collectively our policies 
for MIPS aim to minimize burden for these practices.

[[Page 53785]]

    Comment: Several commenters were supportive of CMS's alternative 
approach to reweight the advancing care information performance 
category to the quality and improvement activities performance 
categories, in order to not place undue emphasis on the quality 
performance category. A few commenters suggested that, in cases where a 
MIPS eligible clinician's advancing care information performance 
category is reweighted to quality, CMS provide a 50 percent base score 
for the quality performance category to better align with scoring for 
the advancing care information performance category and to not unfairly 
penalize these MIPS eligible clinicians.
    Response: We continue to believe that redistributing the advancing 
care information weight to quality is appropriate because of the 
experience MIPS eligible clinicians have reporting on quality measures 
under other CMS programs. We appreciate these comments and will take 
them into consideration in future rulemaking, when MIPS eligible 
clinicians have more experience reporting on the improvement activities 
performance category.
    Comment: One commenter requested that CMS not redistribute the cost 
performance category weight in future years for non-patient facing MIPS 
eligible clinicians who do not have sufficient cost measures.
    Response: We appreciate the feedback and will take into 
consideration in future rulemaking. We note that in section 
II.C.6.d.(2) of this final rule with comment period, we finalized that 
the cost performance category weight for the 2018 MIPS performance 
period and the 2020 MIPS payment year is 10 percent. As a result, if 
there are not sufficient cost measures applicable and available to a 
MIPS eligible clinician, we are finalizing the proposal to redistribute 
the cost performance category weight to the quality performance 
category, or if a MIPS eligible clinician does not receive a quality 
performance category percent score because there are not sufficient 
quality measures applicable and available to the clinician, to 
redistribute the cost performance category weight equally to the 
remaining performance categories that are not reweighted.
    Final Action: After consideration of public comments, we are 
finalizing our proposals for redistributing the performance category 
weights for the 2020 MIPS payment year, with the exception of the 
proposals that assume the cost performance category will be weighted at 
zero percent in the final score as proposed, because in section 
II.C.6.d.(2) of this final rule with comment period, we finalized that 
the cost performance category weight for the 2018 MIPS performance 
period and the 2020 MIPS payment period is 10 percent. Table 29 
summarizes the final reweighting policies for the 2018 MIPS performance 
period and 2020 MIPS payment year.

              Table 29--Performance Category Redistribution Policies for the 2020 MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
                                                                                                  Advancing care
              Reweighting scenario                  Quality (%)      Cost (%)       Improvement     information
                                                                                  activities (%)        (%)
----------------------------------------------------------------------------------------------------------------
                                      No Reweighting Needed
----------------------------------------------------------------------------------------------------------------
--Scores for all four performance categories....              50              10              15              25
----------------------------------------------------------------------------------------------------------------
                                Reweight One Performance Category
----------------------------------------------------------------------------------------------------------------
--No Cost.......................................              60               0              15              25
--No Advancing Care Information.................              75              10              15               0
--No Quality....................................               0              10              45              45
--No Improvement Activities.....................              65              10               0              25
----------------------------------------------------------------------------------------------------------------
                               Reweight Two Performance Categories
----------------------------------------------------------------------------------------------------------------
--No Cost and no Advancing Care Information.....              85               0              15               0
--No Cost and no Quality........................               0               0              50              50
--No Cost and no Improvement Activities.........              75               0               0              25
--No Advancing Care Information and no Quality..               0              10              90               0
--No Advancing Care Information and no                        90              10               0               0
 Improvement Activities.........................
--No Quality and no Improvement Activities......               0              10               0              90
----------------------------------------------------------------------------------------------------------------

8. MIPS Payment Adjustments
a. Payment Adjustment Identifier and Final Score Used in Payment 
Adjustment Calculation
(1) Payment Adjustment Identifier
    For purposes of applying the MIPS payment adjustment under section 
1848(q)(6)(E) of the Act, we finalized a policy in the CY 2017 Quality 
Payment Program final rule to use a single identifier, TIN/NPI, for all 
MIPS eligible clinicians, regardless of whether the TIN/NPI was 
measured as an individual, group or APM Entity group (81 FR 77329 
through 77330). In other words, a TIN/NPI may receive a final score 
based on individual, group, or APM Entity group performance, but the 
MIPS payment adjustment would be applied at the TIN/NPI level.
    We did not propose any changes to the MIPS payment adjustment 
identifier.
(2) Final Score Used in Payment Adjustment Calculation
    In CY 2017 Quality Payment Program final rule (81 FR 77330 through 
77332), we finalized a policy to use a TIN/NPI's performance from the 
performance period associated with the MIPS payment adjustment. We also 
proposed the following policies, and, although we received public 
comments on them and responded to those comments, we inadvertently 
failed to state that we were finalizing these policies, although it was 
our intention to do so. Thus, we clarify that the following final 
policies apply beginning with the transition year. For groups 
submitting data using the TIN identifier, we will apply the group final 
score to all the TIN/NPI combinations that bill under that TIN during 
the performance period. For individual MIPS eligible clinicians 
submitting data using TIN/NPI, we will

[[Page 53786]]

use the final score associated with the TIN/NPI that is used during the 
performance period. For MIPS eligible clinicians in MIPS APMs, we will 
assign the APM Entity group's final score to all the APM Entity 
Participant Identifiers that are associated with the APM Entity. For 
MIPS eligible clinicians that participate in APMs for which the APM 
scoring standard does not apply, we will assign a final score using 
either the individual or group data submission assignments.
    In the case where a MIPS eligible clinician starts working in a new 
practice or otherwise establishes a new TIN that did not exist during 
the performance period, there would be no corresponding historical 
performance information or final score for the new TIN/NPI. In cases 
where there is no final score associated with a TIN/NPI from the 
performance period, we will use the NPI's performance for the TIN(s) 
the NPI was billing under during the performance period. If the MIPS 
eligible clinician has only one final score associated with the NPI 
from the performance period, then we will use that final score. In the 
event that an NPI bills under multiple TINs in the performance period 
and bills under a new TIN in the MIPS payment year, we finalized a 
policy of taking the highest final score associated with that NPI in 
the performance period (81 FR 77332).
    In some cases, a TIN/NPI could have more than one final score 
associated with it from the performance period, if the MIPS eligible 
clinician submitted duplicative data sets. In this situation, the MIPS 
eligible clinician has not changed practices; rather, for example, a 
MIPS eligible clinician has a final score for an APM Entity and a final 
score for a group TIN. If a MIPS eligible clinician has multiple final 
scores, the following hierarchy will apply. If a MIPS eligible 
clinician is a participant in MIPS APM, then the APM Entity final score 
would be used instead of any other final score. If a MIPS eligible 
clinician has more than one APM Entity final score, we will apply the 
highest APM Entity final score to the MIPS eligible clinician. If a 
MIPS eligible clinician reports as a group and as an individual and not 
as an APM Entity, we will calculate a final score for the group and 
individual identifier and use the highest final score for the TIN/NPI 
(81 FR 77332).
    For a further description of our policies, we referred readers to 
the CY 2017 Quality Payment Program final rule (81 FR 77330 through 
77332).
    In addition to the above policies from the CY 2017 Quality Payment 
Program final rule, beginning with the 2020 MIPS payment year, we 
proposed to modify the policies to address the addition of virtual 
groups. Section 1848(q)(5)(I)(i) of the Act provides that MIPS eligible 
clinicians electing to be a virtual group must: (1) Have their 
performance assessed for the quality and cost performance categories in 
a manner that applies the combined performance of all the MIPS eligible 
clinicians in the virtual group to each MIPS eligible clinician in the 
virtual group for the applicable performance period; and (2) be scored 
for the quality and cost performance categories based on such 
assessment. Therefore, when identifying a final score for payment 
adjustments, we must prioritize a virtual group final score over other 
final scores such as individual and group scores. Because we also wish 
to encourage movement towards APMs, we will prioritize using the APM 
Entity final score over any other score for a TIN/NPI, including a TIN/
NPI that is in a virtual group. If a TIN/NPI is in both a virtual group 
and a MIPS APM, we proposed to use the waiver authority for Innovation 
Center models under section 1115A(d)(1) of the Act and the Shared 
Savings Program waiver authority under section 1899(f) of the Act to 
waive section 1848(q)(5)(I)(i)(I) and (II) of the Act so that we could 
use the APM Entity final score instead of the virtual group final score 
for a TIN/NPI. As discussed in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30033 through 30034), the use of waiver authority 
is to avoid creating competing incentives between MIPS and the APM. We 
want MIPS eligible clinicians to focus on the requirements of the APM 
to ensure that the models produce valid results that are not confounded 
by the incentives created by MIPS.
    We also proposed to modify our hierarchy to state that if a MIPS 
eligible clinician is not in an APM Entity and is in a virtual group, 
the MIPS eligible clinician would receive the virtual group final score 
over any other final score. Our policies remain unchanged for TIN/NPIs 
who are not in an APM Entity or virtual group. Tables 40 and 41 in the 
CY 2018 Quality Payment Program proposed rule summarized the final and 
proposed policies (82 FR 30147).
    We will only apply the associated final score to clinicians or 
groups who are not otherwise excluded from MIPS. We invited public 
comment on our proposals.
    The following is a summary of the public comments received and our 
responses:
    Comment: A few commenters supported the prioritization of the APM 
Entity final score over any virtual group scores for the TIN/NPI and 
agreed that this prioritization will help encourage eligible clinicians 
to move towards APMs.
    Response: We thank the commenters for their support.
    Comment: One commenter did not support the prioritization of the 
APM Entity final score and suggested that a group practice should have 
the option to report both as a group and through an APM Entity, and the 
final score should be the higher of the two scores. One commenter 
believes that APM Entities may receive lower scores for certain 
performance categories, such as the advancing care information 
performance category, compared to their group.
    Response: We believe it is important to align MIPS with APMs and 
believe prioritizing APM Entity scores over other scores creates that 
alignment. We want MIPS eligible clinicians to be able to focus on the 
requirements and redesign required in the APM.
    Comment: One commenter requested additional clarity on how payment 
adjustments will be applied when a MIPS eligible clinician bills under 
more than one TIN/NPI combination. One commenter expressed concern with 
the approach of applying the payment adjustment at the TIN/NPI level 
because of the potential complexities from MIPS eligible clinicians 
changing practices.
    Response: MIPS payment adjustments will be determined for each TIN/
NPI combination. We will use only one final score for a TIN/NPI for 
purposes of determining the MIPS payment adjustment that will be 
applied to that TIN/NPI. If a MIPS eligible clinician bills under more 
than one TIN, that MIPS eligible clinician will receive a separate MIPS 
payment adjustment for each TIN/NPI combination. In addition, since we 
allow each MIPS eligible clinician to decide how they want to report--
individually, through a group, or through an APM Entity as a MIPS APM 
participant--we cannot control the number of submissions that one TIN/
NPI may have for a performance period. To address scenarios where we 
have multiple submissions for one TIN/NPI, we have established the 
policies described earlier in this section to articulate the hierarchy 
of which final score we will use to determine the MIPS payment 
adjustment for a TIN/NPI.
    Final Action: After consideration of the public comments received, 
we are finalizing our policies as proposed.
    Tables 30 and 31 illustrate the final policies for determining 
which final score will be used when more than one final score is 
associated with a TIN/NPI (Table 30) and the final policies that apply 
if there is no final score

[[Page 53787]]

associated with a TIN/NPI from the performance period, such as when a 
MIPS eligible clinician starts working in a new practice or otherwise 
establishes a new TIN (Table 31).

  Table 30--Hierarchy for Final Score When More Than One Final Score Is
                        Associated With a TIN/NPI
------------------------------------------------------------------------
                                          Final score used to determine
                Example                        payment adjustments
------------------------------------------------------------------------
TIN/NPI has more than one APM Entity     The highest of the APM Entity
 final score.                             final scores.
TIN/NPI has an APM Entity final score    APM Entity final score.
 and also has an individual score.
TIN/NPI has an APM Entity final score    APM Entity final score.
 that is not a virtual group score and
 also has a group final score.
TIN/NPI has an APM Entity final score    APM Entity final score.
 and also has a virtual group score.
TIN/NPI has a virtual group score and    Virtual group score.
 an individual final score.
TIN/NPI has a group final score and an   The highest of the group or
 individual final score, but no APM       individual final score.
 Entity final score and is not in a
 virtual group.
------------------------------------------------------------------------


                               Table 31--No Final Score Associated With a TIN/NPI
----------------------------------------------------------------------------------------------------------------
                                                               TIN/NPI billing in        Final score used to
  MIPS eligible clinician (NPI 1)      Performance period    MIPS payment year (yes/      determine payment
                                           final score                 no)                   adjustments
----------------------------------------------------------------------------------------------------------------
TIN A/NPI 1........................  90....................  Yes (NPI 1 is still     90 (Final score for TIN A/
                                                              billing under TIN A     NPI 1 from the performance
                                                              in the MIPS payment     period)
                                                              year).
TIN B/NPI 1........................  70....................  No (NPI 1 has left TIN  n/a (no claims are billed
                                                              B and no longer bills   under TIN B/NPI 1)
                                                              under TIN B in the
                                                              MIPS payment year).
TIN C/NPI 1........................  n/a (NPI 1 was not      Yes (NPI 1 has joined   90 (No final score for TIN
                                      part of TIN C during    TIN C and is billing    C/NPI 1, so use the
                                      the performance         under TIN C in the      highest final score
                                      period).                MIPS payment year).     associated with NPI 1 from
                                                                                      the performance period)
----------------------------------------------------------------------------------------------------------------

b. MIPS Payment Adjustment Factors
    For a description of the statutory background and further 
description of our policies, we refer readers to the CY 2017 Quality 
Payment Program final rule (81 FR 77332 through 77333).
    Although we did not propose any changes to these policies, nor did 
we request public comments, we did receive comments on this topic, 
which we will consider in preparation for future rulemaking.
c. Establishing the Performance Threshold
    Under section 1848(q)(6)(D)(i) of the Act, for each year of the 
MIPS, the Secretary shall compute a performance threshold with respect 
to which the final scores of MIPS eligible clinicians are compared for 
purposes of determining the MIPS payment adjustment factors under 
section 1848(q)(6)(A) of the Act for a year. The performance threshold 
for a year must be either the mean or median (as selected by the 
Secretary, and which may be reassessed every 3 years) of the final 
scores for all MIPS eligible clinicians for a prior period specified by 
the Secretary. Section 1848(q)(6)(D)(iii) of the Act outlines a special 
rule for the initial 2 years of MIPS, which requires the Secretary, 
prior to the performance period for such years, to establish a 
performance threshold for purposes of determining the MIPS payment 
adjustment factors under section 1848(q)(6)(A) of the Act and an 
additional performance threshold for purposes of determining the 
additional MIPS payment adjustment factors under section 1848(q)(6)(C) 
of the Act, each of which shall be based on a period prior to the 
performance period and take into account data available for performance 
on measures and activities that may be used under the performance 
categories and other factors determined appropriate by the Secretary. 
We codified the term performance threshold at Sec.  414.1305 as the 
numerical threshold for a MIPS payment year against which the final 
scores of MIPS eligible clinicians are compared to determine the MIPS 
payment adjustment factors. We codified at Sec.  414.1405(b) that a 
performance threshold will be specified for each MIPS payment year. We 
referred readers to the CY 2017 Quality Payment Program final rule for 
further discussion of the performance threshold (81 FR 77333 through 
77338). In accordance with the special rule set forth in section 
1848(q)(6)(D)(iii) of the Act, we finalized a performance threshold of 
3 points for the transition year (81 FR 77334 through 77338). We 
inadvertently failed to codify the performance threshold for the 2019 
MIPS payment year in the CY 2017 Quality Payment Program final rule, 
although it was our intention to do so. Thus, we now codify the 
performance threshold of 3 points for the 2019 MIPS payment year at 
Sec.  414.1405(b)(4).
    Our goal was to encourage participation and provide an opportunity 
for MIPS eligible clinicians to become familiar with the MIPS program. 
We determined that it would have been inappropriate to set a 
performance threshold that would result in downward adjustments to 
payments for many clinicians who may not have had time to prepare 
adequately to succeed under MIPS. By providing a pathway for many 
clinicians to succeed under MIPS, we believed that we would encourage 
early participation in the program, which may enable more robust and 
thorough engagement with the program over time. We set the performance 
threshold at a low number to provide MIPS eligible clinicians an 
opportunity to achieve a minimum level of success under the program, 
while gaining experience with reporting on the measures and activities 
and becoming familiar with other program

[[Page 53788]]

policies and requirements. We believed if we set the threshold too 
high, using a new formula that is unfamiliar and confusing to 
clinicians, many could be discouraged from participating in the first 
year of the program, which may lead to lower participation rates in 
future years. Additionally, we believed a lower performance threshold 
was particularly important to reduce the initial burden for MIPS 
eligible clinicians in small or solo practices. We believed that active 
participation of MIPS eligible clinicians in MIPS will improve the 
overall quality, cost, and care coordination of services provided to 
Medicare beneficiaries. In accordance with section 1848(q)(6)(D)(iii) 
of the Act, we took into account available data regarding performance 
on measures and activities, as well as other factors we determined 
appropriate. We refer readers to 81 FR 77333 through 77338 for details 
of our analysis. We also stated our intent to increase the performance 
threshold in the 2020 MIPS payment year, and that, beginning in the 
2021 MIPS payment year, we will use the mean or median final score from 
a prior period as required by section 1848(q)(6)(D)(i) of the Act (81 
FR 77338).
    For the 2020 MIPS payment year, we again wanted to use the 
flexibility provided in section 1848(q)(6)(D)(iii) to help transition 
MIPS eligible clinicians to the 2021 MIPS payment year, when the 
performance threshold will be the mean or median of the final scores 
for all MIPS eligible clinicians from a prior period. We wanted to 
encourage continued participation and the collection of meaningful data 
by MIPS eligible clinicians. A higher performance threshold would help 
MIPS eligible clinicians strive to achieve more complete reporting and 
better performance and prepare MIPS eligible clinicians for the 2021 
MIPS payment year. However, a performance threshold set too high could 
also create a performance barrier, particularly for MIPS eligible 
clinicians who did not previously participate in PQRS or the EHR 
Incentive Programs. We have heard from stakeholders requesting that we 
continue a low performance threshold and from stakeholders requesting 
that we ramp up the performance threshold to help MIPS eligible 
clinicians prepare for the 2021 MIPS payment year and to meaningfully 
incentivize higher performance. Given our desire to provide a 
meaningful ramp between the transition year's 3-point performance 
threshold and the 2021 MIPS payment year performance threshold using 
the mean or median of the final scores for all MIPS eligible clinicians 
for a prior period, we proposed to set the performance threshold at 15 
points for the 2020 MIPS payment year (82 FR 30147 through 30149).
    We proposed a performance threshold of 15 points because it 
represents a meaningful increase, compared to 3 points in the 
transition year, while maintaining flexibility for MIPS eligible 
clinicians in the pathways available to achieve this performance 
threshold. We refer readers to the CY 2018 Quality Payment Program 
proposed rule (82 FR 30148) for examples of how clinicians could meet 
or exceed a performance threshold of 15 points based on our proposed 
policies.
    We believed the proposed performance threshold would mitigate 
concerns from MIPS eligible clinicians about participating in the 
program for the second year. However, we remained concerned that moving 
from a performance threshold of 15 points for the 2020 MIPS payment 
year to a performance threshold of the mean or median of the final 
scores for all MIPS eligible clinicians for a prior period for the 2021 
MIPS payment year may be a steep jump.
    By the 2021 MIPS payment year, MIPS eligible clinicians would 
likely need to submit most of the required information and perform well 
on the measures and activities to receive a positive MIPS payment 
adjustment. Therefore, we also sought comment on setting the 
performance threshold either lower or higher than the proposed 15 
points for the 2020 MIPS payment year. A performance threshold lower 
than the proposed 15 points for the 2020 MIPS payment year presents the 
potential for a significant increase in the final score a MIPS eligible 
clinician must earn to meet the performance threshold in the 2021 MIPS 
payment year, as well as providing for a potentially smaller total 
amount of negative MIPS payment adjustments upon which the total amount 
of the positive MIPS payment adjustments would depend due to the budget 
neutrality requirement under section 1848(q)(6)(F)(ii) of the Act. A 
performance threshold higher than the proposed 15 points would increase 
the final score required to receive a neutral MIPS payment adjustment, 
which may be particularly challenging for small practices, even with 
the proposed addition of the small practice bonus. A higher performance 
threshold would also allow for potentially higher positive MIPS payment 
adjustments for those who exceed the performance threshold.
    We considered an alternative of setting a performance threshold of 
6 points, which could be met by submitting 2 quality measures with 
required data completeness or one high-weighted improvement activity. 
While this lower performance threshold may provide a sharp increase to 
the required performance threshold in the 2021 MIPS payment year (the 
mean or median of the final scores for all MIPS eligible clinicians for 
a prior period), it would continue to reward clinicians for 
participation in MIPS as they transition into the program.
    We also considered an alternative of setting the performance 
threshold at 33 points, which would require full participation both in 
improvement activities and in the quality performance category (either 
for a small group or for a large group that meets data completeness 
standards) to meet the performance threshold. Such a threshold would 
make the step to the required mean or median performance threshold in 
the 2021 MIPS payment year less steep but could present further 
challenges to clinicians who have not previously participated in legacy 
quality reporting programs.
    As required by section 1848(q)(6)(D)(iii) of the Act, for the 
purposes of determining the performance threshold, we considered data 
available for performance on measures and activities that may be used 
under the MIPS performance categories. We refer readers to the CY 2018 
Quality Payment Program proposed rule (82 FR 30147 through 30149) for a 
discussion of the data we considered.
    We invited public comments on the proposal to set the performance 
threshold at 15 points, and also sought comment on setting the 
performance threshold at the alternative of 6 points or at 33 points 
for the 2020 MIPS payment year. We also sought public comments on 
principles and considerations for setting the performance threshold 
beginning with the 2021 MIPS payment year, which will be the mean or 
median of the final scores for all MIPS eligible clinicians from a 
prior period.
    The following is a summary of the public comments received on our 
proposals for the performance threshold and our responses:
    Comment: Many commenters supported the performance threshold of 15 
points because it will provide an incremental increase over the 3-point 
performance threshold from the transition year; provide a helpful 
ramping up of performance standards; encourage more participation in 
MIPS; prepare clinicians to focus on the delivery of high quality care 
to help them eventually advance toward APM

[[Page 53789]]

participation; and represents a meaningful increase in the performance 
threshold while maintaining flexibility for clinicians to achieve the 
threshold in multiple ways. One commenter recommended a performance 
threshold higher than 5 points.
    Response: We thank the commenters for their support. We are 
finalizing the performance threshold at 15 points. Please refer to 
section II.C.8.g.(2) of this final rule with comment period for 
additional details on multiple ways clinicians and groups can meet or 
exceed the performance threshold.
    Comment: Many commenters supported a lower performance threshold 
without a specific numerical recommendation because the commenters 
believe that the increase to 15 points would put an increased burden of 
additional requirements on MIPS eligible clinicians, that a lower 
threshold would encourage clinician participation, provide flexibility 
for clinicians to meet the performance threshold, and would allow 
clinicians to become more familiar with MIPS and more successful, 
particularly for gastroenterologists. One commenter encouraged CMS to 
maintain as low a performance threshold as possible for 2018 since the 
second year of MIPS is still considered a transition year, and the 
commenter indicated many clinicians are still expected to be at various 
levels of readiness and comfort with the program. One commenter 
believes that the lower performance threshold would allow CRNAs and 
other MIPS eligible clinicians to gain greater familiarity with QCDR 
measure reporting and improvement activities.
    Response: We acknowledge the concerns expressed by many commenters. 
We recognize that the 2020 MIPS payment year is still a transition year 
for MIPS, and we believe the proposed performance threshold of 15 
points modestly increases the threshold from the transition year, while 
encouraging increased engagement and participation in the MIPS program 
and preparing clinicians for additional participation requirements in 
the 2021 MIPS performance period. We note that this performance 
threshold would allow for many options for a MIPS eligible clinician to 
succeed under MIPS. For example, submitting the maximum number of 
improvement activities could qualify for a final score of 15 points 
because improvement activities performance category is worth 15 percent 
of the final score. The performance threshold could also be met by full 
participation in the quality performance category--by submitting all 
required measures with the necessary data completeness, MIPS eligible 
clinicians would earn a quality performance category percent score of 
at least 30 percent (which is at least 3 measure achievement points out 
of 10 measure points for each required measure). If the quality 
performance category is weighted at 50 percent, then the quality 
performance category would be 30 percent x 50 percent x 100 which 
equals 15 points toward the final score and meets the performance 
threshold. Finally, a MIPS eligible clinician could achieve a final 
score of 15 points through an advancing care information performance 
category score of 60 percent or higher (60 percent advancing care 
information performance category score x 25 percent performance 
category weight x 100 equals 15 points towards the final score). Please 
refer to section II.C.8.g.(2) of this final rule with comment period 
for additional details on ways to meet or exceed the performance 
threshold.
    Comment: A few commenters stated that setting a lower performance 
threshold is especially important because stakeholders do not have data 
from the first performance period and are unsure how well clinicians 
understand MIPS requirements and whether clinicians are ready for a 
more challenging program. The commenters expressed their belief that 
CMS's current program estimates are overly optimistic and may be 
inflated. A few commenters suggested that CMS delay implementing a 
significant increase in the performance threshold until a complete 
analysis of the 2017 data is performed because that would be consistent 
with efforts to ensure a smooth transition in the 2018 performance 
period.
    Response: We appreciate the commenters' concerns with the proposed 
performance threshold and their request for a delay in increasing the 
performance threshold until we have more information about how 
clinicians are performing under MIPS. However, beginning with the 2021 
MIPS payment year, section 1848(q)(6)(D)(i) of the Act requires the 
performance threshold to be either the mean or median of the final 
scores for all MIPS eligible clinicians for a prior period, which could 
result in a significant increase in the performance threshold in the 
2021 MIPS payment year. We believe that setting the performance 
threshold at 15 points for the 2020 MIPS payment year is appropriate 
because it encourages increased participation and prepares clinicians 
for the additional participation requirements to meet or exceed the 
increased performance threshold that is statutorily required in the 
2021 MIPS payment year. We also do not believe that increasing the 
performance threshold to 15 points is a significant increase, but is 
rather a moderate step that provides an opportunity for clinicians to 
gain experience with all MIPS performance categories before the 
performance threshold changes in the 2021 MIPS payment year and a 
clinician will likely need to participate more fully and perform well 
on multiple performance categories to earn a score high enough to 
receive a positive adjustment. We have based our regulatory impact 
analysis estimates on the best available data and two sets of 
participation assumptions; we do not believe our participation 
assumptions are overly inflated or inaccurate based on the data 
available. We refer readers to the CY 2018 Quality Payment Program 
proposed rule (82 FR 30147 through 30149) for details on the data 
considered. While we anticipate we will have more accurate program 
information after the first year of MIPS, we do not believe it is 
appropriate to have a performance threshold below 15 points as our 
program estimates do not impact the statutory requirement to set the 
performance threshold at either the mean or median of the final scores 
for all MIPS eligible clinicians for a prior period starting in the 
2021 MIPS payment year.
    Comment: A few commenters believe a performance threshold of 15 
points is excessively steep because clinicians will no longer be able 
to report on only one measure to avoid a negative payment adjustment 
and because some clinicians may not be ready to submit enough data to 
reach the proposed performance threshold of 15 points. One commenter 
recommended only a minimal increase (something less than the proposed 
15 points) in the performance threshold because of concern with drastic 
fluctuations in performance threshold numbers. One commenter 
recommended that CMS simplify and clarify performance scoring through 
future regulation to allow clinicians to better assess the scoring and 
weighting of each performance category because any increases in the 
performance threshold make it more difficult for clinicians to combine 
reporting on measures and activities to avoid a negative payment 
adjustment.
    Response: We disagree with the characterization that a performance 
threshold of 15 points is excessively steep. We believe a performance 
threshold of 15 points is an incremental increase over the 3-point 
performance threshold from the transition year and will provide a 
modest increase in what

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clinicians need to do to succeed in MIPS. As discussed earlier in this 
section, there are many ways a clinician can earn a final score of 15 
points from reporting for just a single performance category. We also 
believe this provides an opportunity for clinicians to gain experience 
with all MIPS performance categories before the performance threshold 
changes in the 2021 MIPS payment year, and a clinician will likely need 
to perform well on multiple performance categories to earn a score high 
enough to receive a positive payment adjustment. We will continue to 
address any changes to the MIPS program in future rulemaking.
    Comment: One commenter did not support the increase from 3 points 
in the 2019 MIPS payment year to 15 points for the 2020 MIPS payment 
year because of the impact on clinicians integrating CEHRT into their 
practices.
    Response: We do not believe CEHRT integration will impact the 
ability of MIPS eligible clinicians to meet or exceed the performance 
threshold because in section II.C.6.f.(4) of this final rule with 
comment period, we adopted a policy to allow the use of 2014 Edition or 
2015 Edition CEHRT, or a combination of the two Editions, for the 
performance period in 2018. A clinician can also meet a performance 
threshold of 15 points without participating in the advancing care 
information performance category.
    Comment: Several commenters recommended CMS maintain the 
performance threshold at 3 points because the 2020 MIPS payment year is 
a transition year, MIPS is complex, and CMS should continue to offer an 
``on-ramp'' for clinicians to transition and integrate into MIPS. One 
commenter stated that an increase could harm MIPS eligible clinicians' 
ability to provide the care that patients need. One commenter believes 
that 15 points would be too steep an increase at this early juncture in 
the MIPS program. One commenter stated that clinicians are still trying 
to understand the program requirements and invest in submission 
mechanisms that make the most sense for their practice. One commenter 
recommended that the performance threshold remain at 3 points until 
MIPS eligible clinician participation can be assessed so that impact on 
small practices could be evaluated. One commenter believes that current 
threshold of 3 points would reward clinicians who are implementing 
quality measures into their practices while encouraging those who are 
reluctant to do so as well.
    Response: We do not believe that maintaining the performance 
threshold at 3 points for the 2020 MIPS payment year appropriately 
encourages clinicians to actively participate in MIPS. We believe a 
meaningful increase to a performance threshold of 15 points maintains 
appropriate flexibility for clinicians to meet or exceed the threshold, 
while requiring increased participation over the level of engagement 
required to meet or exceed the 3-point threshold used in the transition 
year. We also believe the increased participation better prepares 
clinicians to succeed under MIPS in future years and will improve the 
overall quality, cost, and care coordination of services to Medicare 
beneficiaries. We are also mindful of the impact of meeting additional 
requirements on small practices and have added a small practice bonus 
as discussed in section II.C.7.b.(1)(c) of this final rule with comment 
period, which may help them meet the performance threshold. 
Additionally, we have modified our quality performance category scoring 
policy, which allows small practices to receive a minimum of 3 measure 
achievement points for every measure submitted, even if the measure 
does not meet the data completeness criteria.
    Comment: Several commenters recommended a performance threshold of 
6 points, rather than the proposed 15 points, because it would relieve 
some of the burden of increased participation from the transition year, 
particularly for solo practitioners and small group practices, and 
would encourage participation providing clinicians with the opportunity 
to avoid a negative MIPS payment adjustment by submitting a minimal 
amount of data. A few commenters stated that lowering the threshold to 
6 points would be appropriate for another transition year, keep the 
program stable, and minimize the potential of penalizing clinicians who 
are still learning about the program and care for the most vulnerable 
patients in our country. A few commenters acknowledged CMS's concerns 
that setting a lower performance threshold in the 2018 MIPS performance 
period could lead to a jump in the performance threshold for the 2019 
MIPS performance period, when CMS is required to use either the mean or 
median final score from a prior period. However, the commenters 
believes that setting a lower performance threshold in 2018 would lead 
to a lower performance threshold in the future because many clinicians 
would be aiming to meet the lower performance threshold of 6 points 
which would lower the mean or median final score for 2018. A few 
commenters supported a performance threshold at 6 points to be 
implemented along with provisions, such as additional bonus points, 
that protect clinicians and groups whose final scores are below the 
performance threshold due to performance category reweighting. One 
commenter believes 6 points would be a more modest performance 
threshold which would enable practices to upgrade their EHR software 
and more effectively track measures and improvement activities and 
comply with interoperability expectations. One commenter urged CMS to 
consider the impact of the level of participation that would be 
required to meet a performance threshold of 6 points in the MIPS 
program.
    Response: We believe that increasing the performance threshold to 6 
points for the 2020 MIPS payment year would not adequately encourage 
increased clinician participation in MIPS and would not prepare 
clinicians for the additional participation requirements in the 2021 
MIPS payment year in order to avoid a negative adjustment. We recognize 
the challenges unique to clinicians in solo and small group practices 
participating in MIPS, but note that solo and small group practices 
must also meet the additional participation requirements in the 2021 
MIPS payment year, and refer readers to section II.C.7.b.(1)(c) of this 
final rule with comment for the provisions related to the small 
practice bonus for the 2020 MIPS payment year. We also do not agree 
that setting a performance threshold at 6 points for 2018 MIPS 
performance period will preclude a significant increase in the 
performance threshold for the 2019 MIPS performance period because 
performance data does not support that the mean or median of clinician 
scores for a particular performance period is limited to a number at or 
near the performance threshold. We refer readers to the CY 2018 Quality 
Payment Program proposed rule (82 FR 30147 through 30149) for a 
discussion of the data we considered. Finally, we believe that 15 point 
performance threshold is attainable even for those who have a 
performance category score reweighted. We refer readers to section 
II.C.8.g.(2) for scoring examples where the advancing care information 
performance category is reweighted and yet MIPS eligible clinicians are 
able to receive a final score higher than 15 points.
    Comment: A few commenters recommended a performance threshold 
between 8 and 13 points. One commenter supported a performance 
threshold between 8 and 10 points to lessen the increase from the 2017

[[Page 53791]]

performance period and to have less of an impact on small practices. 
One commenter recommended that CMS set the performance threshold at 7 
to 10 points because of the lower expected participation rate of small 
practices. One commenter recommended that the performance threshold be 
increased by no more than 7 to 10 points in any given year because any 
more is too much of an increase to implement in a year. One commenter 
encouraged CMS to consider a longer transition period and suggested 
that 10 points would be an appropriate performance threshold because it 
would enable growth over the 2019 MIPS payment year, but at not as 
steep a climb as the proposed 15 points.
    Response: We appreciate the suggestions for a range of increases in 
the performance threshold from 7 points to 13 points. We also 
appreciate the concerns expressed by many commenters about clinicians 
needing more clarity around MIPS program requirements and additional 
time to prepare to participate in MIPS and meet program requirements. 
We agree that setting the performance threshold for the 2018 MIPS 
performance period significantly higher than the performance threshold 
for the 2017 MIPS performance period would be inappropriate because 
many clinicians need time to become familiar with the program policies 
and requirements and gain experience with increased participation under 
the MIPS program. However, we believe that clinicians should be 
prepared to meet the additional requirements for meeting, or exceeding, 
the significantly increased performance threshold statutorily required 
in the 2021 MIPS payment year. As such, we believe that the performance 
threshold of 15 points will encourage increased participation and 
adequately prepare clinicians for these additional participation 
requirements in the 2021 MIPS payment year. Additionally, we refer 
readers to section II.C.7.b.(1)(c) of this final rule with comment 
where we finalize the small practice bonus for the 2020 MIPS payment 
year which may help clinicians in small practices meet the performance 
threshold of 15 points.
    Comment: Many commenters supported a higher performance threshold 
with no specific numerical recommendation because the additional 
increase would encourage participation in multiple performance 
categories, appropriately focus clinicians on quality and improvement 
activities that are critical steps in moving towards value-based care, 
and would make a higher performance threshold for the 2021 MIPS payment 
year less steep. One commenter recommended setting the performance 
threshold closer to the cumulative number of points a clinician would 
earn for minimum participation across all MIPS performance categories 
to incentivize clinicians who are almost ready for full participation 
to make the necessary practice changes and investments.
    Response: We understand the perspective expressed by some 
commenters that a higher performance threshold would better prepare 
clinicians for the expected increase in the performance threshold for 
the 2021 MIPS payment year and would encourage increased clinician 
participation in the MIPS program and the movement toward value-based 
care. While we acknowledge these advantages to setting a higher 
performance threshold for the 2020 MIPS payment year, we also believe 
that we should provide MIPS eligible clinicians with a smooth 
transition to the second year of the program to encourage continued 
participation. We believe that a performance threshold of 15 points is 
a sufficient increase over the 2017 MIPS performance period that would 
encourage continued clinician participation with an increased 
engagement whereas a higher performance threshold may discourage 
clinicians from participating in MIPS, which in the long run does not 
improve quality of care for beneficiaries. We appreciate the suggestion 
to set the performance threshold at a number to encourage minimum 
participation in all of the performance categories, however, we believe 
that the additional performance threshold, which we are establishing at 
70 points as discussed in section II.C.8.d. of this final rule with 
comment period, will provide incentive for reporting on all of the 
performance categories.
    Comment: A few commenters expressed concerns that the proposed 
performance threshold would limit the opportunity for MIPS eligible 
clinicians performing above average to earn up to a 5 percent positive 
payment adjustment in 2020 because of the proposals to expand 
exclusions from reporting and make more bonus points available.
    Response: We acknowledge that setting the performance threshold at 
a low number may limit the maximum payment adjustment amount that high 
performers could receive, due to the budget neutrality requirement in 
the statute, but we believe that this is warranted in a transition year 
to encourage clinician participation in MIPS.
    Comment: A few commenters supported the alternative of 33 points 
because they believe it is attainable, would better prepare clinicians 
for the steep increase expected for the 2021 MIPS payment year, send 
the message to clinicians that focusing on quality and improvement 
activities are critical steps in moving towards value-based care, 
reward high-performing clinicians who have invested in performance 
improvement, and result in higher positive MIPS payment adjustments for 
MIPS eligible clinicians who exceed the performance threshold thereby 
incentivizing higher performance. One commenter supported a performance 
threshold of 33 points because if a clinician that had a neutral 
adjustment in the VM program and had successfully demonstrated 
meaningful use under the EHR Incentive Program delivered the same 
performance under MIPS, then the clinician could expect to receive a 
final score of 53 points. This commenter believes that this ``status 
quo'' performance threshold of 53 points, which is significantly higher 
than either the proposed 15 point or the alternative 33 point 
threshold, supported a performance threshold of 33 points.
    One commenter supported a performance threshold of 33 points 
because it would require participation in both the improvement 
activities and quality performance categories to avoid a negative 
adjustment. One commenter supported a 33-point performance threshold 
because the combined effect of the proposed changes for 2018, including 
the performance threshold, the low-volume threshold, small practice 
bonus, and EHR certification requirements, would reduce the opportunity 
for high-performing MIPS eligible clinicians to earn a reasonable 
increase to their Medicare payments in the 2020 MIPS payment year. One 
commenter recommended for those practices where a 33-point performance 
threshold may present a challenge because they have not participated in 
the legacy Medicare programs, CMS can assist them through the existing 
Transforming Clinical Practice Initiative (TCPI) that would help 
clinicians identify and report quality measures under the MIPS quality 
performance category.
    Response: We appreciate the commenters' feedback regarding the 
alternative of 33 points. We believe the proposed performance threshold 
of 15 points is appropriate for the 2020 MIPS payment year because it 
represents a meaningful increase compared to 3 points in the transition 
year, while maintaining multiple pathways for MIPS eligible clinicians 
to achieve and or exceed the performance threshold. We want to 
encourage clinician

[[Page 53792]]

participation and believe that setting a performance threshold too high 
for the 2020 MIPS payment year could create a performance barrier, 
particularly for clinicians that have not previously participated in 
PQRS or the EHR Incentive Programs. We want to encourage MIPS eligible 
clinicians to participate because that will provide better data for us 
to measure performance and ultimately help drive the delivery of value-
based, quality health care. In the long run, we would prefer the 
negative MIPS payment adjustments to be caused by poor performance 
rather than non-participation. Because the statute requires the MIPS 
payment adjustments to be budget neutral, a performance threshold of 15 
points could lower the potential positive MIPS payment adjustment for 
high performers compared to a higher performance threshold. However, we 
believe the trade-off to encourage participation is warranted in the 
second transition year. We agree that technical assistance can help 
practices understand MIPS and transform care and have set up the Small, 
Underserved, and Rural Support initiative, a 5-year program, to provide 
technical support to MIPS eligible clinicians in small practices. The 
program provides assistance to practices in selecting and reporting on 
quality measures, education and outreach, and support for optimizing 
health IT.
    Comment: A few commenters suggested a performance threshold higher 
of at least 30 points and up to 45 points. One commenter supported a 
threshold of at least 30 points because this would better prepare 
clinicians for the likely higher performance threshold for the 2019 
MIPS performance period and would be fair for groups that have invested 
time and resources preparing for the MIPS program. One commenter 
recommended a performance threshold of approximately 40 to 45 points 
because that would incentivize clinicians to familiarize themselves 
with the reporting requirements and accelerate initial improvement 
efforts to ensure higher performance in future program years. One 
commenter recommended a performance threshold of 42.5 points because 
that would be closer to the cumulative number of points a clinician 
would earn for minimum participation across all MIPS performance 
categories, ensure that eligible clinicians participate in the quality 
performance category to avoid a negative payment adjustment, and would 
encourage clinicians to gain experience in each performance category 
and familiarize themselves with the program's reporting requirements so 
that they can better focus on performance in future program years.
    Response: We appreciate the commenters' suggestions for alternative 
higher performance thresholds of 30 points, 42.5 points, and a number 
between 40 and 45 points. However, we believe that setting the 
performance threshold too high could discourage clinician participation 
which may lead to lower clinician participation in future years. 
Accordingly, we believe clinicians should have an opportunity to become 
more familiar with the MIPS program and gain experience with reporting 
on measures and activities for the different MIPS performance 
categories with only a modest increase in the MIPS performance 
threshold from the 2017 MIPS performance period to the 2018 MIPS 
performance period. We believe that a performance threshold of 15 
points does not preclude clinicians from participating in multiple 
performance categories and that clinicians can and should participate 
in all performance categories. We are encouraged clinicians are 
investing in the time and resources to perform well in MIPS and expect 
that will benefit these clinicians through receiving a positive MIPS 
payment adjustment and additional MIPS payment adjustment (for those 
with a final score equal or greater than 70 points, as discussed in 
section II.C.8.d. of this final rule with comment period.) While having 
a lower performance threshold many limit the amount of the positive 
payment adjustment, we believe the trade-off to encourage participation 
is warranted in the second transition year.
    Comment: One commenter recommended setting the performance 
threshold at a level that would require eligible clinicians to 
participate in at least 2 performance categories to avoid a negative 
payment adjustment, including the quality performance category, because 
this would incentivize clinicians to familiarize themselves with all 
the reporting requirements in the program, particularly the quality 
performance category, so that they can focus on performance improvement 
in future program years. One commenter suggested that CMS consider 
alternative approaches to setting the performance threshold that would 
reduce the burden on small practices and clinicians and groups 
practicing in rural and underserved areas by establishing different 
performance thresholds for specific groups.
    Response: We appreciate your suggestions for alternative approaches 
when setting the performance threshold. We believe the proposed 
performance threshold of 15 points provides a pathway to success for 
many clinicians in the MIPS program through increased participation and 
do not want to add additional complexity with establishing a 
performance threshold or placing additional requirements for submitting 
for multiple performance categories. We believe that requiring MIPS 
eligible clinicians to submit on more than one performance category to 
meet the performance threshold to avoid a negative payment adjustment 
could be a barrier to participation, particularly for clinicians 
gaining experience with reporting on the measures and activities and 
becoming familiar with program policies and requirements. However, we 
also believe that a performance threshold of 15 points does not 
preclude clinicians from participating in multiple performance 
categories and that clinicians can and should participate in all 
performance categories. In addition, the scoring policies in the MIPS 
program take into account the needs of small practices and the impact 
on clinicians serving complex patients; however, the statute requires a 
single performance threshold for all MIPS eligible clinicians. Please 
refer to sections II.C.7.b.(1)(b) and II.C.7.b.(1)(c) of this final 
rule with comment period for a discussion of these policies.
    Comment: Several commenters offered input on the 2021 MIPS payment 
year requirement that the performance threshold be either the median or 
mean of the final scores for a prior period and other suggested 
modifications to the performance threshold.
    Response: We thank the commenters for their input, and although we 
did not propose or request comments on the performance threshold for 
the 2021 MIPS payment year, we will take these comments into 
consideration in future rulemaking.
    Final Action: After consideration of the public comments, we are 
finalizing the performance threshold for the 2020 MIPS payment year as 
proposed at 15 points. We are codifying the performance threshold for 
the 2020 MIPS payment year at Sec.  414.1405(b)(5).
d. Additional Performance Threshold for Exceptional Performance
    Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to 
compute, for each year of the MIPS, an additional performance threshold 
for purposes of determining the additional MIPS payment adjustment 
factors for exceptional performance under paragraph (C). For each such 
year, the Secretary shall apply either of the

[[Page 53793]]

following methods for computing the additional performance threshold: 
(1) The threshold shall be the score that is equal to the 25th 
percentile of the range of possible final scores above the performance 
threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2) 
the threshold shall be the score that is equal to the 25th percentile 
of the actual final scores for MIPS eligible clinicians with final 
scores at or above the performance threshold for the prior period 
described in section 1848(q)(6)(D)(i) of the Act.
    We codified at Sec.  414.1305 the definition of additional 
performance threshold as the numerical threshold for a MIPS payment 
year against which the final scores of MIPS eligible clinicians are 
compared to determine the additional MIPS payment adjustment factors 
for exceptional performance. We also codified at Sec.  414.1405(d) that 
an additional performance threshold will be specified for each of the 
MIPS payment years 2019 through 2024. We referred readers to the CY 
2017 Quality Payment Program final rule for further discussion of the 
additional performance threshold (81 FR 77338 through 77339). We 
inadvertently failed to codify the additional performance threshold for 
the 2019 MIPS payment year in the CY 2017 Quality Payment Program final 
rule, although it was our intention to do so. Thus, we now codify the 
additional performance threshold for the 2019 MIPS payment year at 
Sec.  414.1405(d)(3).
    Based on the special rule for the initial 2 years of MIPS in 
section 1848(q)(6)(D)(iii) of the Act, for the transition year, we 
decoupled the additional performance threshold from the performance 
threshold and established the additional performance threshold at 70 
points. We selected a 70-point numerical value for the additional 
performance threshold, in part, because it would require a MIPS 
eligible clinician to submit data for and perform well on more than one 
performance category (except in the event the advancing care 
information performance category is reweighted to zero percent and the 
weight is redistributed to the quality performance category making the 
quality performance category worth 85 percent of the final score). 
Under section 1848(q)(6)(C) of the Act, a MIPS eligible clinician with 
a final score at or above the additional performance threshold will 
receive an additional MIPS payment adjustment factor and may share in 
the $500,000,000 of funding available for the year under section 
1848(q)(6)(F)(iv) of the Act. We believed these additional incentives 
should only be available to those clinicians with very high performance 
on the MIPS measures and activities. We took into account the data 
available and the modeling described in section II.E.7.c.(1) of the CY 
2017 Quality Payment Program final rule in selecting the additional 
performance threshold for the transition year (81 FR 77338 through 
77339).
    As we discussed in the CY 2018 Quality Payment Program proposed 
rule (82 FR 30147 through 30149), we relied on the special rule under 
section 1848(q)(6)(D)(iii) of the Act to establish the performance 
threshold at 15 points for 2020 MIPS payment year. We proposed to again 
decouple the additional performance threshold from the performance 
threshold. Because we do not have actual MIPS final scores for a prior 
performance period, if we do not decouple the additional performance 
threshold from the performance threshold, then we would have to set the 
additional performance threshold at the 25th percentile of possible 
final scores above the performance threshold. With a performance 
threshold set at 15 points, the range of total possible points above 
the performance threshold is 16 to 100 points. The 25th percentile of 
that range is 36.25 points, which is barely more than one third of the 
possible 100 points in the MIPS final score. We do not believe it would 
be appropriate to lower the additional performance threshold to 36.25 
points, as we do not believe a final score of 36.25 points demonstrates 
exceptional performance by a MIPS eligible clinician. We believe these 
additional incentives should only be available to those clinicians with 
very high performance on the MIPS measures and activities. Therefore, 
we relied on the special rule under section 1848(q)(6)(D)(iii) of the 
Act to propose the additional performance threshold at 70 points for 
the 2020 MIPS payment year, which is higher than the 25th percentile of 
the range of the possible final scores above the performance threshold.
    We took into account the data available and the modeling described 
in the CY 2018 Quality Payment Program proposed rule (82 FR 30147 
through 30148) to estimate final scores for the 2020 MIPS payment year. 
We believed 70 points is appropriate because it requires a MIPS 
eligible clinician to submit data for and perform well on more than one 
performance category (except in the event the advancing care 
information measures are not applicable and available to a MIPS 
eligible clinician). Generally, under our proposals, a MIPS eligible 
clinician could receive a maximum score of 60 points for the quality 
performance category, which is below the 70-point additional 
performance threshold. In addition, 70 points is at a high enough level 
that MIPS eligible clinicians must submit data for the quality 
performance category to achieve this target. For example, if a MIPS 
eligible clinician gets a perfect score for the improvement activities 
and advancing care information performance categories, but does not 
submit quality measures data, then the MIPS eligible clinician would 
only receive 40 points (0 points for quality + 15 points for 
improvement activities + 25 points for advancing care information), 
which is below the additional performance threshold. We believed an 
additional performance threshold of 70 points would maintain the 
incentive for excellent performance while keeping the focus on quality 
performance. Finally, we noted that we believed keeping the additional 
performance threshold at 70 points maintains consistency with the 2019 
MIPS payment year which helps to simplify the overall MIPS framework.
    We invited public comment on the proposals. We also sought feedback 
on whether we should raise the additional performance threshold to a 
higher number which would in many instances require the use of an EHR 
for those to whom the advancing care information performance category 
requirements would apply. In addition, a higher additional performance 
threshold would incentivize better performance and would also allow 
MIPS eligible clinicians to receive a higher additional MIPS payment 
adjustment.
    We also sought public comment on which method we should use to 
compute the additional performance threshold beginning with the 2021 
MIPS payment year. Section 1848(q)(6)(D)(ii) of the Act requires the 
additional performance threshold to be the score that is equal to the 
25th percentile of the range of possible final scores above the 
performance threshold for the year, or the score that is equal to the 
25th percentile of the actual final scores for MIPS eligible clinicians 
with final scores at or above the performance threshold for the prior 
period described in section 1848(q)(6)(D)(i) of the Act.
    The following is a summary of the public comments received and our 
responses:
    Comment: Many commenters supported the proposal to keep the 
additional performance threshold at 70 points for the 2018 MIPS 
performance period because this number is high enough to necessitate 
what could be construed as ``exceptional performance'' and low enough 
to be reasonably

[[Page 53794]]

attainable; is sufficient to drive improvement and reward those with 
high performance; is close to full participation in addition to 
requiring good performance in the quality and advancing care 
information categories; avoids shifting program requirements; rewards 
those who submit data on multiple MIPS performance categories; and is 
more appropriate than raising the bar after just 1 year.
    Response: We thank the commenters for their support. We are 
finalizing the additional performance threshold at 70 points.
    Comment: Several commenters recommended an additional performance 
threshold higher than the proposal of 70 points because they believe it 
was merited and that establishing an additional performance threshold 
that allows 4 out of 5 participants to qualify as ``exceptional'' 
performers would dilute the impact of these important incentives and 
potentially reduce clinician motivation to improve performance, 
particularly for those clinicians who expended resources and effort 
preparing to be successful in MIPS in 2017 and 2018.
    A few commenters supported raising the additional performance 
threshold for the 2018 MIPS performance period/2020 MIPS payment year 
to 75 points because this would allow for a potentially larger 
additional MIPS payment adjustment for qualifying clinicians compared 
to an additional performance threshold of 70 points. The increase would 
allow those MIPS eligible clinicians who expended significant effort 
and resources to perform at higher levels and earn a higher incentive 
for their achievement; would account for improvements in technology and 
processes; would align with a proposed increase in the performance 
threshold; and would better prepare the MIPS eligible clinician 
community for the statutory requirements for the 2021 MIPS payment year 
additional performance threshold.
    One commenter supported an additional performance threshold of 80 
points because it would be possible for a MIPS eligible clinician to 
exceed 70 points without reporting on the advancing care information 
measures.
    Response: We appreciate commenters' suggestions for higher 
additional performance thresholds in general and your specific 
recommendations of 75 points and 80 points. We applaud MIPS eligible 
clinicians that have invested in performing well in MIPS. We want to 
reward exceptional performance, yet also have an achievable additional 
performance threshold that encourages clinicians to participate more 
fully. We disagree with the characterization that the proposal of 70 
points will reduce clinician motivation to perform because there is no 
certainty about the number of clinicians who will qualify for the 
additional MIPS payment adjustment and the impact of this number on the 
size of the additional MIPS payment adjustment. We also believe that 
keeping the additional performance threshold the same as in the 2017 
MIPS performance period will encourage continued participation from 
clinicians who have experience with and understand what is required to 
meet and exceed the 70-point threshold.
    Comment: Several commenters offered input on the 2021 MIPS payment 
year statutory requirements for the additional performance threshold 
and other suggested modifications to the additional performance 
threshold.
    Response: We thank the commenters for their input, and although we 
did not propose or request comments on the additional performance 
threshold for the 2021 MIPS payment year, we will take these comments 
into consideration in future rulemaking.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to set the additional performance threshold at 
70 points for the 2020 MIPS payment year. We are codifying the 
additional performance threshold for the 2020 MIPS payment year in this 
final rule at Sec.  414.1405(d)(4).
e. Scaling/Budget Neutrality
    We codified at Sec.  414.1405(b)(3) that a scaling factor not to 
exceed 3.0 may be applied to positive MIPS payment adjustment factors 
to ensure budget neutrality such that the estimated increase in 
aggregate allowed charges resulting from the application of the 
positive MIPS payment adjustment factors for the MIPS payment year 
equals the estimated decrease in aggregate allowed charges resulting 
from the application of negative MIPS payment adjustment factors for 
the MIPS payment year. We referred readers to the CY 2017 Quality 
Payment Program final rule for further discussion of budget neutrality 
(81 FR 77339).
    We did not propose any changes to the scaling and budget neutrality 
requirements as they are applied to MIPS payment adjustment factors in 
this proposed rule.
f. Additional Adjustment Factors
    We referred readers to the CY 2017 Quality Payment Program final 
rule for further discussion of the additional MIPS payment adjustment 
factor (81 FR 77339 through 77340). We did not propose any changes to 
determine the additional MIPS payment adjustment factors.
g. Application of the MIPS Payment Adjustment Factors
(1) Application to the Medicare Paid Amount
    Section 1848(q)(6)(E) of the Act provides that for items and 
services furnished by a MIPS eligible clinician during a year 
(beginning with 2019), the amount otherwise paid under Part B for such 
items and services and MIPS eligible clinician for such year, shall be 
multiplied by 1 plus the sum of the MIPS payment adjustment factor 
determined under section 1848(q)(6)(A) of the Act divided by 100, and 
as applicable, the additional MIPS payment adjustment factor determined 
under section 1848(q)(6)(C) of the Act divided by 100.
    We codified at Sec.  414.1405(e) the application of the MIPS 
payment adjustment factors. For each MIPS payment year, the MIPS 
payment adjustment factor, and if applicable the additional MIPS 
payment adjustment factor, are applied to Medicare Part B payments for 
items and services furnished by the MIPS eligible clinician during the 
year.
    We proposed to apply the MIPS payment adjustment factor, and if 
applicable, the additional MIPS payment adjustment factor, to the 
Medicare paid amount for items and services paid under Part B and 
furnished by the MIPS eligible clinician during the year. This proposal 
is consistent with the approach taken for the value-based payment 
modifier (77 FR 69308 through 69310) and would mean that beneficiary 
cost-sharing and coinsurance amounts would not be affected by the 
application of the MIPS payment adjustment factor and the additional 
MIPS payment adjustment factor. The MIPS payment adjustment applies 
only to the amount otherwise paid under Part B for items and services 
furnished by a MIPS eligible clinician during a year. Please refer to 
the CY 2017 Quality Payment Program final rule at 81 FR 77340 and the 
CY 2018 Quality Payment Program proposed rule at 82 FR 30019 and 
section II.C.1.a. of this final rule with comment period for further 
discussion and our proposals regarding which Part B covered items and 
services would be subject to the MIPS payment adjustment.
    The following is a summary of the public comments received on these 
proposals and our responses:

[[Page 53795]]

    Comment: A few commenters supported the proposal to apply the 
adjustment to the Medicare paid amount because it would not affect the 
Medicare beneficiary deductible and coinsurance amounts.
    Response: We thank the commenters for their support.
    Comment: One commenter did not support the proposal and recommended 
that the MIPS payment adjustment apply to the full fee schedule amount. 
The commenter questioned the statutory authority for the proposal and 
expressed a belief that section 1848(q)(6)(E) of the Act applies the 
adjustment to the full fee schedule amount. In addition, the commenter 
stated that the proposal would not accomplish its objective as savings 
would be passed on to the supplemental insurance industry and not to 
beneficiaries.
    Response: We disagree with the commenter's interpretation of the 
statute. We assume the commenter is referring to the Medicare Physician 
Fee Schedule. Section 1848(q)(6)(E) of the Act, requires us to apply 
the adjustment to ``the amount otherwise paid under this part,'' which 
we interpret to refer to Medicare Part B payments, with respect to 
items and services furnished by a MIPS eligible clinician. We believe 
the language of this section gives us discretion to apply the 
adjustment to the Medicare paid amount as we proposed. We also disagree 
with the characterization that the proposal would not accomplish its 
objective because the MIPS program is focused on rewarding value and 
outcomes for MIPS eligible clinicians and is intended to improve the 
overall quality, cost, and care coordination of services provided to 
Medicare beneficiaries.
    Comment: One commenter requested guidance on how the MIPS payment 
adjustment will be applied for non-participating clinicians. 
Specifically, the commenter expressed concerns about the administrative 
burden of maintaining a separate fee schedule for MIPS eligible 
clinicians and non-participating clinicians. The commenter also 
requested guidance regarding whether the MIPS adjustment is used in 
calculating the Medicare limiting charge amount for non-participating 
clinicians, whether we will provide the annual Medicare Physician Fee 
Schedule with the relating limiting charge amount for both MIPS 
eligible clinicians as well as non-participating clinicians, and 
whether there are different limiting charge amounts for MIPS eligible 
clinicians receiving the MIPS payment adjustment and for clinicians not 
subject to MIPS.
    Response: We appreciate the commenter's questions and note that 
although we did not address these issues in the proposed rule, we 
intend to address them in rulemaking next year.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to apply the MIPS payment adjustment factor, 
and if applicable, the additional MIPS payment adjustment factor, to 
the Medicare paid amount for items and services paid under Part B and 
furnished by the MIPS eligible clinician during the year. We refer 
readers to section II.C.1.a. of this final rule with comment period, 
where we discuss the items and services to which the MIPS payment 
adjustment could be applied under Part B.
(2) Example of Adjustment Factors
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30152) 
we provided a figure and several tables as illustrative examples of how 
various final scores would be converted to an adjustment factor, and 
potentially an additional adjustment factor, using the statutory 
formula and based on proposed policies. We repeat these examples using 
our final policies. In Figure A, the performance threshold is 15 
points. The applicable percentage is 5 percent for 2020. The adjustment 
factor is determined on a linear sliding scale from zero to 100, with 
zero being the lowest negative applicable percentage (negative 5 
percent for the 2020 MIPS payment year), and 100 being the highest 
positive applicable percentage. However, there are two modifications to 
this linear sliding scale. First, there is an exception for a final 
score between zero and one-fourth of the performance threshold (zero 
and 3.75 points based on the performance threshold of 15 points for the 
2020 MIPS payment year). All MIPS eligible clinicians with a final 
score in this range would receive the lowest negative applicable 
percentage (negative 5 percent for the 2020 MIPS payment year). Second, 
the linear sliding scale line for the positive MIPS adjustment factor 
is adjusted by the scaling factor, which cannot be higher than 3.0 (as 
discussed in section II.C.8.e. of this final rule with comment and in 
the CY 2018 Quality Payment Program proposed rule at 82 FR 30150). If 
the scaling factor is greater than zero and less than or equal to 1.0, 
then the adjustment factor for a final score of 100 would be less than 
or equal to 5 percent. If the scaling factor is above 1.0, but less 
than or equal to 3.0, then the adjustment factor for a final score of 
100 would be higher than 5 percent. Only those MIPS eligible clinicians 
with a final score equal to 15 points (which is the performance 
threshold in this example) would receive a neutral MIPS payment 
adjustment. Because the performance threshold is 15 points, we 
anticipate that the scaling factor would be less than 1.0 and the 
payment adjustment for MIPS eligible clinicians with a final score of 
100 points would be less than 5 percent.
    Figure A illustrates an example of the slope of the line for the 
linear adjustments. In this example, the scaling factor for the 
adjustment factor is 0.06 which is much lower than 1.0. In this 
example, MIPS eligible clinicians with a final score equal to 100 would 
have an adjustment factor of 0.31 percent (5 percent x 0.06).
    The additional performance threshold is 70 points. An additional 
adjustment factor of 0.5 percent starts at the additional performance 
threshold and increases on a linear sliding scale up to 10 percent. 
This linear sliding scale line is also multiplied by a scaling factor 
that is greater than zero and less than or equal to 1.0. The scaling 
factor will be determined so that the estimated aggregate increase in 
payments associated with the application of the additional adjustment 
factors is equal to $500,000,000. In Figure A, the example scaling 
factor for the additional adjustment factor is 0.175. Therefore, MIPS 
eligible clinicians with a final score of 100 would have an additional 
adjustment factor of 1.75 percent (10 percent x 0.175). The total 
adjustment for a MIPS eligible clinician with a final score equal to 
100 would be 1 + 0.0031 + 0.0175 = 1.0205, for a total positive MIPS 
payment adjustment of 2.05 percent.
BILLING CODE 4120-01-P

[[Page 53796]]

[GRAPHIC] [TIFF OMITTED] TR16NO17.000

BILLING CODE 4120-01-C
    The final MIPS payment adjustments will be determined by the 
distribution of final scores across MIPS eligible clinicians and the 
performance threshold. More MIPS eligible clinicians above the 
performance threshold means the scaling factors would decrease because 
more MIPS eligible clinicians receive a positive MIPS payment 
adjustment. More MIPS eligible clinicians below the performance 
threshold means the scaling factors would increase because more MIPS 
eligible clinicians would have negative MIPS payment adjustments and 
relatively fewer MIPS eligible clinicians would receive positive MIPS 
payment adjustments.
    Table 32 illustrates the changes in payment adjustments from the 
transition year to the 2020 MIPS payment year based on the final 
policies, as well as the statutorily-required increase in the 
applicable percent as required by section 1848(q)(6)(B) of the Act.

    Table 32--Illustration of Point System and Associated Adjustments
    Comparison Between Transition Year and the 2020 MIPS Payment Year
------------------------------------------------------------------------
            Transition year                   2020 MIPS payment year
------------------------------------------------------------------------
                                           Final score
  Final score points    MIPS adjustment      points      MIPS adjustment
------------------------------------------------------------------------
0.0-0.75..............  Negative 4             0.0-3.75  Negative 5
                         percent.                         percent.

[[Page 53797]]

 
0.76-2.99.............  Negative MIPS        3.76-14.99  Negative MIPS
                         payment                          payment
                         adjustment                       adjustment
                         greater than                     greater than
                         negative 4                       negative 5
                         percent and                      percent and
                         less than 0                      less than 0
                         percent on a                     percent on a
                         linear sliding                   linear sliding
                         scale.                           scale.
3.00..................  0 percent                 15.00  0 percent
                         adjustment.                      adjustment.
3.01-69.99............  Positive MIPS       15.01-69.99  Positive MIPS
                         payment                          payment
                         adjustment                       adjustment
                         greater than 0                   greater than 0
                         percent on a                     percent on a
                         linear sliding                   linear sliding
                         scale. The                       scale. The
                         linear sliding                   linear sliding
                         scale ranges                     scale ranges
                         from 0 to 4                      from 0 to 5
                         percent for                      percent for
                         scores from                      scores from
                         3.00 to                          15.00 to
                         100.00. This                     100.00. This
                         sliding scale                    sliding scale
                         is multiplied                    is multiplied
                         by a scaling                     by a scaling
                         factor greater                   factor greater
                         than zero but                    than zero but
                         not exceeding                    not exceeding
                         3.0 to                           3.0 to
                         preserve                         preserve
                         budget                           budget
                         neutrality.                      neutrality.
70.00-100.............  Positive MIPS         70.00-100  Positive MIPS
                         payment                          payment
                         adjustment                       adjustment
                         greater than 0                   greater than 0
                         percent on a                     percent on a
                         linear sliding                   linear sliding
                         scale. The                       scale. The
                         linear sliding                   linear sliding
                         scale ranges                     scale ranges
                         from 0 to 4                      from 0 to 5
                         percent for                      percent for
                         scores from                      scores from
                         3.00 to                          15.00 to
                         100.00. This                     100.00. This
                         sliding scale                    sliding scale
                         is multiplied                    is multiplied
                         by a scaling                     by a scaling
                         factor greater                   factor greater
                         than zero but                    than zero but
                         not exceeding                    not exceeding
                         3.0 to                           3.0 to
                         preserve                         preserve
                         budget                           budget
                         neutrality;                      neutrality;
                         PLUS.                            PLUS.
                        An additional                    An additional
                         MIPS payment                     MIPS payment
                         adjustment for                   adjustment for
                         exceptional                      exceptional
                         performance.                     performance.
                         The additional                   The additional
                         MIPS payment                     MIPS payment
                         adjustment                       adjustment
                         starts at 0.5                    starts at 0.5
                         percent and                      percent and
                         increases on a                   increases on a
                         linear sliding                   linear sliding
                         scale. The                       scale. The
                         linear sliding                   linear sliding
                         scale ranges                     scale ranges
                         from 0.5 to 10                   from 0.5 to 10
                         percent for                      percent for
                         scores from                      scores from
                         70.00 to                         70.00 to
                         100.00. This                     100.00. This
                         sliding scale                    sliding scale
                         is multiplied                    is multiplied
                         by a scaling                     by a scaling
                         factor not                       factor not
                         greater than                     greater than
                         1.0 in order                     1.0 in order
                         to                               to
                         proportionatel                   proportionatel
                         y distribute                     y distribute
                         the available                    the available
                         funds for                        funds for
                         exceptional                      exceptional
                         performance.                     performance.
------------------------------------------------------------------------

    In the CY 2018 Quality Payment Program proposed rule, we provided a 
few examples for the 2020 MIPS payment year to demonstrate scenarios in 
which MIPS eligible clinicians can achieve a final score at or above 
the performance threshold of 15 points. We note a calculation error was 
included in Example 3. Because the MIPS eligible clinician did not 
submit advancing care information, the quality performance category 
should have been 85 percent to reflect reweighting, while the advancing 
care information performance category should have been zero percent. 
Earned points (column D) should have been 42.5 for quality to reflect 
reweighting and the final score should have been listed as 51.5.
    We have provided updated examples below for the 2020 MIPS payment 
year to demonstrate scenarios in which MIPS eligible clinicians can 
achieve a final score at or above the performance threshold of 15 
points based on our final policies.
Example 1: MIPS Eligible Clinician in Small Practice Submits 1 Quality 
Measure and 1 Improvement Activity
    In the example illustrated in Table 32, a MIPS eligible clinician 
in a small practice reporting individually meets the performance 
threshold by reporting one quality measure one time via claims and one 
medium-weight improvement activity. The practice does not submit data 
for the advancing care information performance category, but does 
submit a significant hardship exception application which is approved; 
therefore, the weight for the advancing care information performance 
category is reweighted to the quality performance category due to final 
reweighting policies discussed in section II.C.7.b.(3) of this final 
rule with comment period (82 FR 30141 through 30146). We also assumed 
the small practice has a cost performance category percent score of 50 
percent. Finally, we assumed a complex patient bonus of 3 points which 
represents the average HCC risk score for the beneficiaries seen by the 
MIPS eligible clinician as well as the proportion of Medicare 
beneficiaries that are dual eligible. There are several special scoring 
rules which affect MIPS eligible clinicians in a small practice:
     3 Measure achievement points for each quality measure even 
if the measure does not meet data completeness standards. We refer 
readers to section II.C.7.a.(2)(d) of this final rule with comment 
period for discussion of this policy. Therefore, a quality measure 
submitted one time would receive 3 points. Because the measure is 
submitted via claims, it does not qualify for the end-to-end electronic 
reporting bonus, nor would it qualify for the high-priority bonus 
because it is the only measure submitted. Because the MIPS eligible 
clinician does not meet full participation requirements, the MIPS 
eligible clinician does not qualify for improvement scoring. We refer 
readers to section II.C.7.a.(2)(i)(iii) of this final rule with comment 
period for a discussion on full participation requirements. Therefore, 
the quality performance category is (3 measure achievement points + 
zero measure bonus points)/60 total available measure points + zero 
improvement percent score which is 5 percent.
     The advancing care information performance category weight 
is redistributed to the quality performance category so that the 
quality performance category score is worth 75 percent of the final 
score. We refer readers to section II.C.7.b.(3)(d) of this final rule 
with comment period for a discussion of this policy.
     MIPS eligible clinicians in small practices qualify for 
special scoring for improvement activities so a medium weighted 
activity is worth 20 points out of a total 40 possible points for the 
improvement activities performance category. We refer readers to 
section II.C.6.e.(5) of this final rule with comment period for a 
discussion of this policy.
     MIPS eligible clinicians in small practices qualify for 
the 5-point small practice bonus which is applied to the

[[Page 53798]]

final score. We refer readers to section II.C.7.b.(1)(c) of this final 
rule with comment period for a discussion of this policy.
    This MIPS eligible clinician exceeds the performance threshold of 
15 points (but does not exceed the additional performance threshold). 
This score is summarized in Table 33.

                    Table 33--Scoring Example 1, MIPS Eligible Clinician in a Small Practice
----------------------------------------------------------------------------------------------------------------
                                                                                              Earned points ([B]
         Performance category               Performance score           Category weight          * [C] * 100)
[A]                                     [B]......................  [C].....................                  [D]
----------------------------------------------------------------------------------------------------------------
Quality...............................  5%.......................  75%.....................                 3.75
Cost..................................  50%......................  10%.....................                  5.0
Improvement Activities................  20 out of 40 points--50%.  15%.....................                  7.5
Advancing Care Information............  N/A......................  0% (reweighted to                           0
                                                                    quality).
Subtotal (Before Bonuses).............  .........................  ........................                16.25
Complex Patient Bonus.................  .........................  ........................                    3
Small Practice Bonus..................  .........................  ........................                    5
Final Score (not to exceed 100).......  .........................  ........................                24.25
----------------------------------------------------------------------------------------------------------------

Example 2: Group Submission Not in a Small Practice
    In the example illustrated in Table 34, a MIPS eligible clinician 
in a medium size practice participating in MIPS as a group receives 
performance category scores of 75 percent for the quality performance 
category, 50 percent for the cost performance category, and 100 percent 
for the advancing care information and improvement activities 
performance categories. There are many paths for a practice to receive 
a 75 percent score in the quality performance category, so for 
simplicity we are assuming the score has been calculated at this 
amount. The final score is calculated to be 85.5, and both the 
performance threshold of 15 and the additional performance threshold of 
70 are exceeded. Again, for simplicity, we assume a complex patient 
bonus of 3 points. In this example, the group practice does not qualify 
for any special scoring, yet is able to exceed the additional 
performance threshold and will receive the additional MIPS payment 
adjustment.

                    Table 34--Scoring Example 2, MIPS Eligible Clinician in a Medium Practice
----------------------------------------------------------------------------------------------------------------
                                                                                              Earned points ([B]
         Performance category               Performance score           Category weight          * [C] * 100)
[A]                                     [B]......................  [C].....................                  [D]
----------------------------------------------------------------------------------------------------------------
Quality...............................  75%......................  50%.....................                 37.5
Cost..................................  50%......................  10%.....................                    5
Improvement Activities................  40 out of 40 points 100%.  15%.....................                   15
Advancing Care Information............  100%.....................  25%.....................                   25
Subtotal (Before Bonuses).............  .........................  ........................                 82.5
Complex Patient Bonus.................  .........................  ........................                    3
Small Practice Bonus..................  .........................  ........................                    0
Final Score (not to exceed 100).......  .........................  ........................                 85.5
----------------------------------------------------------------------------------------------------------------

Example 3: Non-Patient Facing MIPS Eligible Clinician
    In the example illustrated in Table 35, an individual MIPS eligible 
clinician that is non-patient facing and not in a small practice 
receives performance category scores of 50 percent for the quality 
performance category, 50 percent for the cost performance category, and 
50 percent for 1 medium-weighted improvement activity. Again, there are 
many paths for a practice to receive a 50 percent score in the quality 
performance category, so for simplicity we are assuming the score has 
been calculated. Because the MIPS eligible clinician is non-patient 
facing, they qualify for special scoring for improvement activities and 
receive 20 points (out of 40 possible points) for the medium weighted 
activity. Also, this individual did not submit advancing care 
information measures and qualifies for the automatic reweighting of the 
advancing care information performance category to the quality 
performance category. Again, for simplicity, we assume a complex 
patient bonus of 3 points. The MIPS eligible clinician is not in a 
small practice so does not qualify for the small practice bonus.
    In this example, the final score is 53 and the performance 
threshold of 15 is exceeded while the additional performance threshold 
of 70 is not.

                     Table 35--Scoring Example 3, Non-Patient Facing MIPS Eligible Clinician
----------------------------------------------------------------------------------------------------------------
         Performance category               Performance score           Category weight         Earned points
[A]                                     [B]......................  [C].....................  ([B] * [C] * 100) =
                                                                                                             [D]
----------------------------------------------------------------------------------------------------------------
Quality...............................  50%......................  75%.....................                 37.5
Cost..................................  50%......................  10%.....................                    5
Improvement Activities................  20 out of 40 points for 1  15%.....................                  7.5
                                         medium weight activity.
                                        50%......................

[[Page 53799]]

 
Advancing Care Information............  0%.......................  0% (reweighted to                           0
                                                                    quality).
Subtotal (Before Bonuses).............  .........................  ........................                   50
Complex Patient Bonus.................  .........................  ........................                    3
Small Practice Bonus..................  .........................  ........................                    0
Final Score (not to exceed 100).......  .........................  ........................                   53
----------------------------------------------------------------------------------------------------------------

    We note that these examples are not intended to be exhaustive of 
the types of participants nor the opportunities for reaching and 
exceeding the performance threshold.
9. Review and Correction of MIPS Final Score
a. Feedback and Information To Improve Performance
(1) Performance Feedback
    As we have stated previously in the CY 2017 Quality Payment Program 
final rule (81 FR 77345), we will continue to engage in user research 
with front-line clinicians to ensure we are providing the performance 
feedback data in a user-friendly format, and that we are including the 
data most relevant to clinicians. Any suggestions from user research 
would be considered as we develop the systems needed for performance 
feedback, which would occur outside of the rulemaking process.
    Over the past year, we have conducted numerous user research 
sessions to determine what the community most needs in performance 
feedback. In summary, we have found the users want the following:
    (1) To know as soon as possible how I am performing based on my 
submitted data so that I have confidence that I performed the way I 
thought I would.
    (2) To be able to quickly understand how and why my payments will 
be adjusted so that I can understand how my business will be impacted.
    (3) To be able to quickly understand how I can improve my 
performance so that I can increase my payment in future program years.
    (4) To know how I am performing over time so I can improve the care 
I am providing patients in my practice.
    (5) To know how my performance compares to my peers.
    Based on that research, we have already begun development of real-
time feedback on data submission and scoring where technically feasible 
(some scoring requires all clinician data be submitted, and therefore, 
cannot occur until the end of the submission period). By ``real-time'' 
feedback, we mean instantaneous receipt recognition; for example, when 
a clinician submits their data via our Web site or a third party 
submits data via our Application Program Interface (API), they will 
know immediately if their submission was successful.
    We will continue to provide information for stakeholders who wish 
to participate in user research via our education and communication 
channels. Suggestions can also be sent via the ``Contact Us'' 
information on qpp.cms.gov. However, we noted that suggestions provided 
through this channel would not be considered as comments on the 
proposed rule.
(a) MIPS Eligible Clinicians
    Under section 1848(q)(12)(A)(i) of the Act, we are at a minimum 
required to provide MIPS eligible clinicians with timely (such as 
quarterly) confidential feedback on their performance under the quality 
and cost performance categories beginning July 1, 2017, and we have 
discretion to provide such feedback regarding the improvement 
activities and advancing care information performance categories.
    We proposed to provide, beginning July 1, 2018, performance 
feedback to MIPS eligible clinicians and groups for the quality and 
cost performance categories for the 2017 performance period, and if 
technically feasible, for the improvement activities and advancing care 
information performance categories. We proposed to provide this 
performance feedback at least annually, and as, technically feasible, 
we would provide it more frequently, such as quarterly. If we are able 
to provide it more frequently, we would communicate the expected 
frequency to our stakeholders via our education and outreach 
communication channels.
    Based on public comments summarized and responded to in the CY 2017 
Quality Payment Program final rule (81 FR 77347), we also proposed that 
the measures and activities specified for the CY 2017 performance 
period (for all four MIPS performance categories), along with the final 
score, would be included in the performance feedback provided on or 
about July 1, 2018.
    For cost measures, since we can measure performance using any 12-
month period of prior claims data, we requested comment on whether it 
would be helpful to provide more frequent feedback on the cost 
performance category using rolling 12-month periods or quarterly 
snapshots of the most recent 12-month period; how frequent that 
feedback should be; and the format in which we should make it available 
to clinicians and groups. In addition, as described in sections 
II.C.6.b. and II.C.6.d. of the proposed rule, we stated in the proposed 
rule our intent to provide cost performance feedback in the fall of 
2017 and the summer of 2018 on new episode-based cost measures that are 
currently under development by CMS. With regard to the format of 
feedback on cost measures, we noted how we are considering utilizing 
the parts of the Quality and Resource Use Reports (QRURs) that user 
testing has revealed beneficial while making the overall look and feel 
usable to clinicians. We requested comment on whether that format is 
appropriate or if other formats or revisions to that format should be 
used to provide performance feedback on cost measures.
    The following is a summary of the public comments received on the 
``MIPS Eligible Clinicians'' proposals and our responses:
    Comment: Many commenters asked for more timely feedback. Some 
commenters expressed concern that the data in existing reports may be 
more than 2 or more years out of date and that more recent feedback is 
needed to improve quality and change behaviors. Several commenters 
noted the need for real time feedback in order to be actionable. Many 
commenters noted feedback reports should be available quarterly, semi-
annually, or more frequently than annually. A few commenters noted 
receiving feedback in mid-2018 would be too late to make the necessary 
adjustments to ensure success in the following MIPS performance period 
and requested mid-year performance reports for the start of the 
performance period. One commenter stated that CMS should hold itself 
accountable for annual reports to be

[[Page 53800]]

available no later than the following August, but CMS should aim for 
having them available no later than July. Half-year performance should 
be available no later than the following March, but CMS should aim for 
January. The commenter stated that if CMS is unable to provide timely 
reports, then clinicians should be exempt from MIPS.
    One commenter noted that it is important that CMS reduce the amount 
of time between the performance period and performance feedback from 
CMS to allow practices time to make necessary adjustments before the 
next reporting period begins. The commenter also requested that 
feedback to clinicians should be delivered by CMS to clinicians 
beginning no later than April 1, 2019. A few commenters requested 
technology and system upgrades, so that CMS could improve the way 
performance information is disseminated to physicians and practices, 
such as dashboards or reports on demand. One commenter requested 
quarterly information to ensure the accuracy of the information, 
especially as CMS has proposed posting MIPS performance scores on the 
Physician Compare Web site.
    Another commenter encouraged CMS to release the reports as early as 
possible, at minimum following the MACRA recommendation that data be 
available on a quarterly basis, so that clinicians are not well into 
the next reporting cycle before they learn of their MIPS results and 
performance and can institute workflow changes to ensure success under 
MIPS. One commenter expressed that measure-based feedback is helpful as 
eligible clinicians determine performance improvement plans and select 
measures for future performance periods. One commenter believes that 
patient-level data is helpful to eligible clinicians as they determine 
areas in which additional resources can be allocated.
    Response: Under section 1848(q)(12)(A)(i) of the Act, we are at a 
minimum required to provide MIPS eligible clinicians with timely (such 
as quarterly) confidential feedback on their performance under the 
quality and cost performance categories beginning July 1, 2017, and we 
have discretion to provide such feedback regarding the improvement 
activities and advancing care information performance categories. We 
are finalizing our policy as proposed to provide performance feedback 
annually on the quality and cost performance categories, and as 
technically feasible the improvement activities and advancing care 
information performance categories. As we have indicated previously, 
our goal is to provide even more timely feedback under MIPS as the 
program evolves, and we are continuing to work with stakeholders as we 
build performance feedback to incorporate technology to improve the 
usability of performance feedback. We do note that there are a number 
of challenges with providing feedback more frequently than annually, 
namely that for the MIPS performance period, we can only provide 
feedback on performance as often as data are reported to us; for MIPS, 
this will be an annual basis for all quality submission mechanisms 
except for claims and administrative claims. As soon as the data are 
available on a more frequent basis we can continue exploring the path 
to provide performance feedback on a more frequent basis, such as 
quarterly. The inability to provide more frequent feedback, other than 
annually, is not a reason to be exempted from the Quality Payment 
Program, and by statute there is no authority to create such 
exemptions. For eligible clinicians and groups who use a third party 
intermediary to report data, we expect those intermediaries to provide 
additional performance feedback on top of what CMS is providing through 
the annual performance feedback. Lastly, we are working with 
stakeholders on an API alpha where registries, and other third party 
intermediaries as technically feasible, are currently testing real-time 
feedback capabilities with the intermediary directly sharing the 
feedback with the eligible clinician or group. Lastly, we refer readers 
to section II.C.5. of this final rule with comment period for more 
information on the MIPS performance period.
    Comment: One commenter requested CMS include the advancing care 
information and improvement activities categories in the report as well 
in order for eligible clinicians to familiarize themselves with the 
program and scoring and to enable them to make decisions to support 
their success under MIPS.
    Response: We agree that all four performance categories are 
beneficial to include in performance feedback, and are working to 
incorporate these data into the July 1, 2018 performance feedback, as 
technically feasible. We will continue to work with stakeholders on the 
best way to include all four performance categories in performance 
feedback.
    Comment: One commenter suggested that one person should be able to 
obtain feedback for an entire TIN or even group of TINs at once because 
seeking out a report on each NPI is not sustainable for larger 
organizations.
    Response: We are continuing to evaluate ways to make the data in 
performance feedback more easily accessible to practice managers who 
manage large numbers of clinicians (TINs).
    Comment: One commenter noted that cost category elements could be 
submitted to other entities using APIs.
    Response: We note that the cost category measures for MIPS require 
no submission, and are entirely claims based. Therefore, identifying 
additional submission mechanisms for cost category data appears 
unnecessary.
    Comment: Several commenters suggested feedback on cost measures and 
cost performance category as it relates to performance feedback. Some 
commenters agreed it would be helpful to provide more frequent and 
actionable feedback on the cost performance category using rolling 12-
month periods or quarterly snapshots of the most recent 12-month 
period. One commenter asked for the agency to do this in a transparent 
manner. A few commenters asked for information on cost performance to 
include cost metrics related to episodes of care and comparative data.
    Another commenter expressed concerns that there is limited 
experience in episode grouper and urged CMS to test and evaluate its 
episode grouper methodology and ensure that their application will not 
result in unintended consequences, such as stinting on needed care as a 
way to ensure that costs within the defined episode are contained. 
Another commenter noted that issues such as identifying the correct 
length of the episode window and assigning services to the episode 
(like rehabilitation therapy or imaging, etc.) each take hours to 
resolve and asked that CMS think critically about the MIPS timeline 
needed to build out every episode of care in the Medicare population. 
That commenter further requested that CMS provide stakeholders with a 
time-table for developing Medicare Cost measure episodes as well as a 
list of future episodes under consideration and that once developed, 
the proposed details of the new episode-based cost measures should be 
subject to notice and comment rulemaking in a future proposed rule. 
Finally, the commenter noted that while this performance category 
relies solely on administrative claims data, critical resource use 
related questions like attribution and risk adjustment for medically 
complex patients still need solutions that can only be answered with 
additional time and through CMS collaboration with the relevant 
professions.

[[Page 53801]]

    Response: We will take this into consideration as we continue to 
build the mechanisms and formats for performance feedback for the 
Quality Payment Program. Additionally, we are actively developing new 
episode-based cost measures, which includes field testing the measures 
that will share such information with clinicians. We will continue to 
engage in user research with front-line clinicians and other 
stakeholders to ensure we are providing the performance feedback data 
in a user-friendly format, and that we are including the data most 
relevant to clinicians. In particular, we have held a Technical Expert 
Panel focused on risk adjustment for episode-based cost measures, which 
has informed the development of potential new episode-based cost 
measures. Any new cost measures would be proposed through rulemaking. 
In terms of clinician involvement, the cost measure development 
contractor has brought together nearly 150 clinicians affiliated with 
nearly 100 specialty societies to both recommend which new cost 
measures to build first and to review and make recommendations for 
every step of cost measure development including which claims to 
include and risk adjustment.
    Comment: One commenter suggested including the following 
information in standardized feedback reports as fields: (1) Indications 
for individual or group classification for non-patient facing, small 
group practice, and rural area and health professional shortage area; 
(2) indications for performance category reweighting and special 
scoring considerations; (3) for the quality performance category, 
including the title of the quality measure submitted, measure type, the 
total points that can be achieved based on the benchmark, whether data 
completeness has been met for the quality measure, decile level 
achieved, measure achievement points, bonus points awarded, and 
performance score; and (4) for the improvement activities category, 
including the title of the improvement activity submitted, weighting of 
the improvement activity, total points that can be earned, special 
scoring applied; and points earned for the measure performance score. 
Another commenter recommended including the following information in 
standardized feedback reports: (1) Eligibility status for both eligible 
clinicians and group practices; (2) for a group practice especially, a 
defined and updated list of NPIs for which the group is responsible 
when reporting at group TIN level; (3) submission status tracking files 
submitted and whether or not the submission was successful; and (4) 
scoring feedback on claim-based universal population quality measures 
and cost measures which is often not available to eligible clinicians 
and groups until after the performance period.
    Response: We agree with commenters about continually improving the 
usability of performance feedback, and will continue doing stakeholder 
outreach with the goal that the template for performance feedback will 
be available in a usable and user-friendly format. We intend to 
consider different options--including all the comments submitted on the 
proposed rule--before the performance feedback is displayed in a web-
based application to MIPS eligible clinicians.
    Final Action: As a result of the public comments, we are finalizing 
these policies as proposed. Specficially, on an annual basis, beginning 
July 1, 2018, performance feedback will be provided to MIPS eligible 
clinicians and groups for the quality and cost performance categories 
for the 2017 performance period, and if technically feasible, for the 
improvement activities and advancing care information performance 
categories.
    We also solicited comment only on how often cost data should be 
provided in performance feedback under the Quality Payment Program, as 
well as, which data fields in the QRUR that would be useful to include 
in the Quality Payment Program performance feedback.
    We received a number of comments on this item and appreciate the 
input received. As this was a request for comment only, we will take 
the feedback provided into consideration for the future as we continue 
to build performance feedback.
(b) MIPS APMs
    We proposed that MIPS eligible clinicians who participate in MIPS 
APMs would receive performance feedback in 2018 and future years of the 
Quality Payment Program, as technically feasible. We referred readers 
to section II.C.6.g.(5) of the proposed rule for additional information 
related to the proposal. A summary of comments on those proposals can 
be found in section II.C.6.g.(5) of this final rule with comment 
period.
(c) Voluntary Clinician and Group Reporting
    As noted in the CY 2017 Quality Payment Program final rule (81 FR 
77071), 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 payment adjustment. In the 
CY 2017 Quality Payment Program final rule (81 FR 77346), we summarized 
public comments requesting that eligible clinicians who are not 
required, but who voluntarily report on measures and activities under 
MIPS, should receive the same access to performance feedback as MIPS 
eligible clinicians; there, we indicated that we would take the 
comments into consideration in the future development of performance 
feedback. We proposed to furnish performance feedback to eligible 
clinicians and groups that do not meet the definition of a MIPS 
eligible clinician but voluntarily report on measures and activities 
under MIPS. We proposed that this would begin with data collected in 
performance period 2017, and would be available beginning July 1, 2018. 
Based on user and market research, we believe that making this 
information available would provide value in numerous ways. First, it 
would help clinicians who are excluded from MIPS in the 2017 
performance period, but who may be considered MIPS eligible clinicians 
in future years, to prepare for participation in the Quality Payment 
Program when there are payment consequences associated with 
participation. Second, it would give all clinicians equal access to the 
CMS claims and benchmarking data available in performance feedback. And 
third, it would allow clinicians who may be interested in participating 
in an APM to make a more informed decision.
    The following is a summary of the public comments received on the 
``Voluntary Clinician and Group Reporting'' proposals and our 
responses:
    Comment: A few commenters supported providing feedback reports to 
clinicians who do not meet the definition of MIPS eligible clinician, 
but voluntarily report measures and activities to MIPS, beginning July 
1, 2018, and containing information on data submitted in the 2017 
performance period, because MIPS provides a valuable introduction to 
value-based payment for clinicians that may not have previously 
encountered it, which will help them better understand the program and 
prepare for successful participation in the future if they become MIPS 
eligible.
    Response: We agree this data will be useful and are finalizing this 
proposal.
    Final Action: As a result of the public comments, we are finalizing 
this policy as proposed. Specifically, starting with data collected in 
the performance period 2017 that would be available beginning

[[Page 53802]]

July 1, 2018, we will furnish performance feedback to eligible 
clinicians and groups that do not meet the definition of a MIPS 
eligible clinician but voluntarily report on measures and activities 
under MIPS.
(2) Mechanisms
    Under section 1848(q)(12)(A)(ii) of the Act, the Secretary may use 
one or more mechanisms to make performance feedback available, which 
may include use of a web-based portal or other mechanisms determined 
appropriate by the Secretary. For the quality performance category, 
described in section 1848(q)(2)(A)(i) of the Act, the feedback shall, 
to the extent an eligible clinician chooses to participate in a data 
registry for purposes of MIPS (including registries under sections 
1848(k) and (m) of the Act), be provided based on performance on 
quality measures reported through the use of such registries. For any 
other performance category (that is, cost, improvement activities, or 
advancing care information), the Secretary shall encourage provision of 
feedback through qualified clinical data registries (QCDRs) as 
described in section 1848(m)(3)(E) of the Act.
    As previously stated in the CY 2017 Quality Payment Program final 
rule (81 FR 77347 through 77349), we will use a CMS-designated system 
as the mechanism for making performance feedback available, which we 
expect will be a web-based application. We expect to use a new and 
improved format for the next performance feedback, anticipated to be 
released around July 1, 2018. It will be provided via the Quality 
Payment Program Web site (qpp.cms.gov), and we intend to leverage 
additional mechanisms, such as health IT vendors, registries, and QCDRs 
to help disseminate data and information contained in the performance 
feedback to eligible clinicians, where applicable.
    We also sought comment on how health IT, either in the form of an 
EHR or as a supplemental module, could better support the feedback 
related to participation in the Quality Payment Program and quality 
improvement in general. Specifically--
     Are there specific health IT functionalities that could 
contribute significantly to quality improvement?
     Are there specific health IT functionalities that could be 
part of a certified EHR technology or made available as optional health 
IT modules in order to support the feedback loop related to Quality 
Payment Program participation or participation in other HHS reporting 
programs?
     In what other ways can health IT support clinicians 
seeking to leverage quality data reports to inform clinical improvement 
efforts? For example, are there existing or emerging tools or resources 
that could leverage an API to provide timely feedback on quality 
improvement activities?
     Are there opportunities to expand existing tracking and 
reporting for use by clinicians, for example expanding the feedback 
loop for patient engagement tools to support remote monitoring of 
patient status and access to education materials?
    We welcomed public comment on these questions.
    We also noted in the proposed rule that we intend to continue to 
leverage third party intermediaries as a mechanism to provider 
performance feedback (82 FR 30155 through 30156). In the CY 2017 
Quality Payment Program final rule (81 FR 77367 through 77386) we 
finalized that at least 4 times per year, qualified registries and 
QCDRs will provide feedback on all of the MIPS performance categories 
that the qualified registry or QCDR reports to us (improvement 
activities, advancing care information, and/or quality performance 
category). The feedback should be given to the individual MIPS eligible 
clinician or group (if participating as a group) at the individual 
participant level or group level, as applicable, for which the 
qualified registry or QCDR reports. The qualified registry or QCDR is 
only required to provide feedback based on the MIPS eligible 
clinician's data that is available at the time the performance feedback 
is generated. In regard to third party intermediaries, we also noted we 
would look to propose ``real time'' feedback as soon as it is 
technically feasible.
    We also noted in the proposed rule (82 FR 30156) that, per the 
policies finalized in the CY 2017 Quality Payment Program final rule 
(81 FR 77367 through 77386), we require qualified registries and QCDRs, 
as well as encourage other third party intermediaries (such as health 
IT vendors that submit data to us on behalf of a MIPS eligible 
clinician or group), to provide performance feedback to individual MIPS 
eligible clinicians and groups via the third party intermediary with 
which they are already working. We also noted that we understand that 
performance feedback is valuable to individual clinicians and groups, 
and seek feedback from third party intermediaries on when ``real-time'' 
feedback could be provided.
    As discussed in the proposed rule (see 82 FR 30156), we plan to 
continue to work with third party intermediaries as we continue to 
develop the mechanisms for performance feedback, to see where we may be 
able to develop and implement efficiencies for the Quality Payment 
Program. We are exploring options with an API, which could allow 
authenticated third party intermediaries to access the same data that 
we use to provide confidential feedback to the individual clinicians 
and groups on whose behalf the third party intermediary reports for 
purposes of MIPS, in accordance with applicable law, including, but not 
limited to, the HIPAA Privacy and Security Rules. Our goal is to enable 
individual clinicians and groups to more easily access their feedback 
via the mechanisms and relationships they already have established. We 
referred readers to section II.C.10. of the proposed rule for 
additional information on Third Party Data Submission.
    We solicited comment only on mechanisms used for performance 
feedback but did not propose any specific policy.
    We received a number of comments on this item and appreciate the 
input received. As this was a request for comment only, we will take 
the feedback provided into consideration for the future as we continue 
to build performance feedback.
(3) Receipt of Information
    Section 1848(q)(12)(A)(v) of the Act, states that the Secretary may 
use the mechanisms established under section 1848(q)(12)(A)(ii) of the 
Act to receive information from professionals. This allows for expanded 
use of the feedback mechanism to not only provide feedback on 
performance to MIPS eligible clinicians, but to also receive 
information from professionals.
    In the CY 2017 Quality Payment Program final rule (81 FR 77350), we 
discussed that we intended to explore the possibility of adding this 
feature to the CMS-designated system, such as a portal, in future years 
under MIPS. Although we did not make any specific proposals at this 
time, we sought comment on the features that could be developed for the 
expanded use of the feedback mechanism. This could be a feature where 
eligible clinicians and groups can send their feedback (for example, if 
they are experiencing issues accessing their data, technical questions 
about their data, etc.) to us through the Quality Payment Program 
Service Center or the Quality Payment Program Web site. We noted that 
we appreciate that eligible clinicians and groups may have questions 
regarding the Quality Payment Program information contained in their 
performance feedback. To assist

[[Page 53803]]

eligible clinicians and groups, we intend to utilize existing 
resources, such as a helpdesk or offer technical assistance, to help 
address questions with the goal of linking these resource features to 
the Quality Payment Program Web site and Service Center.
    We solicited comment only on the receipt of information on features 
that could be developed for the expanded use of the feedback mechanism 
but did not propose any specific policy.
    We received a number of comments on this item and appreciate the 
input received. As this was a request for comment only, we will take 
the feedback provided into consideration for the future as we continue 
to build performance feedback. As a reminder, we have already 
established a single helpdesk to address all questions related to the 
Quality Payment Program. Please visit our Web site at qpp.cms.gov for 
more information.
(4) Additional Information--Type of Information
    Section 1848(q)(12)(B)(i) of the Act states that beginning July 1, 
2018, the Secretary shall make available to MIPS eligible clinicians 
information about the items and services for which payment is made 
under Title 18 that are furnished to individuals who are patients of 
MIPS eligible clinicians by other suppliers and providers of services. 
This information may be made available through mechanisms determined 
appropriate by the Secretary, such as the CMS-designated system that 
would also provide performance feedback. Section 1848(q)(12)(B)(ii) of 
the Act specifies that the type of information provided may include the 
name of such providers, the types of items and services furnished, and 
the dates that items and services were furnished. Historical data 
regarding the total, and components of, allowed charges (and other 
figures as determined appropriate by the Secretary) may also be 
provided.
    We proposed, beginning with the performance feedback provided 
around July 1, 2018, to make available to MIPS eligible clinicians and 
eligible clinicians information about the items and services for which 
payment is made under Title 18 that are furnished to individuals who 
are patients of MIPS eligible clinicians and eligible clinicians by 
other suppliers and providers of services. We proposed to include as 
many of the following data elements as technically feasible: The name 
of such suppliers and providers of services; the types of items and 
services furnished and received; the dollar amount of services provided 
and received; and the dates that items and services were furnished. We 
proposed that the additional information would include historical data 
regarding the total, and components of, allowed charges (and other 
figures as determined appropriate). We proposed that this information 
be provided on the aggregate level; with the exception of data on items 
and services, as we could consider providing this data at the patient 
level, if clinicians find that level of data to be useful, although we 
noted it may contain personally identifiable information and protected 
health information. We proposed the date range for making this 
information available would be based on what is most helpful to 
clinicians, which could include the most recent data we have available, 
which as technically feasible would be from the previous 3 to 12-month 
period. We proposed to make this information available via the Quality 
Payment Program Web site, and as technically feasible, as part of the 
performance feedback. Finally, because data on items and services 
furnished is generally kept confidential, we proposed that access would 
be provided only after secure credentials are obtained.
    The following is a summary of the public comments received on the 
``Additional Information--Type of Information'' proposals and our 
responses:
    Comment: One commenter supported providing additional information 
about the items and services for which payment is made under Title 
XVIII. The commenter urged CMS to make the information more robust by 
identifying alternatives to the items or services provided that would 
have been more cost effective to the patient while still delivering the 
same quality of care.
    Two commenters provided recommendations for the type of additional 
information to include in performance feedback. One commenter 
recommended that CMS create machine-readable APIs for the feedback 
mechanism so that vendors could then interpret ``raw data,'' thereby 
enabling them to develop visualization and processing tools to better 
understand this data. The commenter believes that providing all data 
and allowing community tools to filter out irrelevant data would 
provide more useful insights to MIPS eligible clinicians. Another 
commenter suggested inclusion of information about which patients are 
attributed to particular clinicians, which other clinicians have 
partnered in that care, and the care directly attributed to the 
clinician. The commenter believes that inclusion of this information 
would better balance the power between CMS to audit and potentially 
recover money with the opportunity for an eligible clinician to seek an 
informal review. Furthermore, the commenter observed that current 
feedback reports lack key details for understanding the methodologies 
used to arrive at the benchmarks and other calculations and encouraged 
CMS to generate a summary report of all measures across the MIPS 
domains per specialty and TIN size, including the ``success'' of each 
measure assessed.
    Response: We appreciate the feedback provided and will consider 
these ideas as we continue to build performance feedback. We are 
continuing to work with registries, QCDRs, and health IT vendors to 
test new APIs and plan to continue to develop new APIs as the Quality 
Payment Program progresses. We also continue to evaluate what 
additional information and type of information as required by section 
1848(q)(12)(B)(i) of the Act would be useful to clinicians and groups, 
and are currently working with stakeholders to establish what to 
include in performance feedback.
    Final Action: As a result of the public comments, we are finalizing 
these policies as proposed. Section 1848(q)(12)(B)(i) of the Act states 
that beginning July 1, 2018, the Secretary shall make available to MIPS 
eligible clinicians information about the items and services for which 
payment is made under Title 18 that are furnished to individuals who 
are patients of MIPS eligible clinicians by other suppliers and 
providers of services.
(5) Performance Feedback Template
    In the proposed rule, we noted our intent (82 FR 30157), to do as 
much as we can of the development of the template for performance 
feedback by working with the stakeholder community in a transparent 
manner. We stated our belief that this will encourage stakeholder 
commentary and make sure the result is the best possible format(s) for 
feedback.
    To continue with our collaborative goal of working with the 
stakeholder community, we sought comment on the structure, format, 
content (for example, detailed goals, data fields, and elements) that 
would be useful for MIPS eligible clinicians and groups to include in 
performance feedback, including the data on items and services 
furnished, as discussed above. Additionally, we understand the term 
``performance feedback'' may not be a meaningful phrase to communicate 
to clinicians or groups the scope of the data. Therefore, we sought 
comment on a more suitable term than ``performance feedback.'' User

[[Page 53804]]

testing to date has provided some considerations for a name in the 
Quality Payment Program, such as Progress Notes, Reports, Feedback, 
Performance Feedback, or Performance Reports.
    Any suggestions on the template to be used for performance feedback 
or what to call ``performance feedback'' can be submitted to the 
Quality Payment Program Web site at qpp.cms.gov.
    We received a number of comments on this item and appreciate the 
input received. As this was a request for comment only and we did nto 
make a proposal, we will take the feedback provided into consideration 
for the future as we continue to build performance feedback. We intend 
to do as much as we can of the development of the template for 
performance feedback by working with the stakeholder community in a 
transparent manner. We invite clinicians and groups that may have ideas 
they want to share, or if they would like to participate in user 
testing to email [email protected]. We think this will both 
encourage stakeholder commentary and make sure we end up with the best 
possible format(s) for feedback. We intend for this performance 
feedback to be available in the new format on the 2017 performance 
period by summer 2018, after the 2017 reporting closes.
b. Targeted Review
    In the CY 2017 Quality Payment Program final rule (81 FR 77546), we 
finalized at Sec.  414.1385 that MIPS eligible clinicians or groups may 
request a targeted review of the calculation of the MIPS payment 
adjustment factor under section 1848(q)(6)(A) of the Act and, as 
applicable, the calculation of the additional MIPS payment adjustment 
factor under section 1848(q)(6)(C) of the Act applicable to such MIPS 
eligible clinician or group for a year. We noted MIPS eligible 
clinicians who are scored under the APM scoring standard described in 
section II.C.6.g. of the proposed rule may request this targeted 
review. Although we did not propose any changes to the targeted review 
process, we provided information on the process that was finalized in 
the CY 2017 Quality Payment Program final rule (81 FR 77353 through 
77358).
    (1) MIPS eligible clinicians and groups have a 60-day period to 
submit a request for targeted review, which begins on the day we make 
available the MIPS payment adjustment factor, and if applicable the 
additional MIPS payment adjustment factor, for the MIPS payment year 
and ends on September 30 of the year prior to the MIPS payment year or 
a later date specified by us.
    (2) We will respond to each request for targeted review timely 
submitted and determine whether a targeted review is warranted. 
Examples under which a MIPS eligible clinician or group may wish to 
request a targeted review include, but are not limited to:
     The MIPS eligible clinician or group believes that 
measures or activities submitted to us during the submission period and 
used in the calculations of the final score and determination of the 
adjustment factors have calculation errors or data quality issues. 
These submissions could be with or without the assistance of a third 
party intermediary; or
     The MIPS eligible clinician or group believes that there 
are certain errors made by us, such as performance category scores were 
wrongly assigned to the MIPS eligible clinician or group (for example, 
the MIPS eligible clinician or group should have been subject to the 
low-volume threshold exclusion, or a MIPS eligible clinician should not 
have received a performance category score).
    (3) The MIPS eligible clinician or group may include additional 
information in support of their request for targeted review at the time 
the request is submitted. If we request additional information from the 
MIPS eligible clinician or group, it must be provided and received by 
us within 30 days of the request. Non-responsiveness to the request for 
additional information may result in the closure of the targeted review 
request, although the MIPS eligible clinician or group may submit 
another request for targeted review before the deadline.
    (4) Decisions based on the targeted review are final, and there is 
no further review or appeal.
c. Data Validation and Auditing
    In the CY 2017 Quality Payment Program final rule (81 FR 77546 
through 77547), we finalized at Sec.  414.1390(a) that we will 
selectively audit MIPS eligible clinicians and groups on a yearly 
basis. If a MIPS eligible clinician or group is selected for audit, the 
MIPS eligible clinician or group will be required to do the following 
in accordance with applicable law and timelines we establish:
    (1) Comply with data sharing requests, providing all data as 
requested by us or our designated entity. All data must be shared with 
us or our designated entity within 45 days of the data sharing request, 
or an alternate timeframe that is agreed to by us and the MIPS eligible 
clinician or group. Data will be submitted via email, facsimile, or an 
electronic method via a secure Web site maintained by us.
    (2) Provide substantive, primary source documents as requested. 
These documents may include: Copies of claims, medical records for 
applicable patients, or other resources used in the data calculations 
for MIPS measures, objectives, and activities. Primary source 
documentation also may include verification of records for Medicare and 
non-Medicare beneficiaries where applicable. We did not propose any 
changes to the requirements in section Sec.  414.1390(a).
    We indicated in the CY 2017 Quality Payment Program final rule that 
all MIPS eligible clinicians and groups that submit data to us 
electronically must attest to the best of their knowledge that the data 
submitted to us is accurate and complete (81 FR 77362). We also 
indicated in the final rule that attestation requirements would be part 
of the submission process (81 FR 77360). We neglected to codify this 
requirement in regulation text of the CY 2017 Quality Payment Program 
final rule. Additionally, after further consideration since the final 
rule, the requirement is more in the nature of a certification, rather 
than an attestation. Thus, we proposed to revise Sec.  414.1390 to add 
a new paragraph (b) that requires all MIPS eligible clinicians and 
groups that submit data and information to CMS for purposes of MIPS to 
certify to the best of their knowledge that the data submitted to CMS 
is true, accurate, and complete. We also proposed that the 
certification by the MIPS eligible clinician or group must accompany 
the submission.
    We also indicated in the CY 2017 Quality Payment Program final rule 
that if a MIPS eligible clinician or group is found to have submitted 
inaccurate data for MIPS, we would reopen and revise the determination 
in accordance with the rules set forth at Sec. Sec.  405.980 through 
405.984 (81 FR 77362). We neglected to codify this policy in regulation 
text of the CY 2017 Quality Payment Program final rule and further, we 
did not include Sec.  405.986, which is also an applicable rule in our 
reopening policy. We also finalized our approach to recoup incorrect 
payments from the MIPS eligible clinician by the amount of any debts 
owed to us by the MIPS eligible clinician and likewise, we would recoup 
any payments from the group by the amount of any debts owed to us by 
the group. Thus, we proposed to revise Sec.  414.1390 to add a new 
paragraph (c) that states we may reopen and revise a MIPS payment 
determination in accordance with the rules set forth at Sec. Sec.  
405.980 through 405.986.

[[Page 53805]]

    In the CY 2017 Quality Payment Program final rule, we also 
indicated that MIPS eligible clinicians and groups should retain copies 
of medical records, charts, reports and any electronic data utilized 
for reporting under MIPS for up to 10 years after the conclusion of the 
performance period (81 FR 77360). We neglected to codify this policy in 
regulation text of the CY 2017 Quality Payment Program final rule. 
Thus, we proposed to revise Sec.  414.1390 to add a new paragraph (d) 
that states that all MIPS eligible clinicians or groups that submit 
data and information to CMS for purposes of MIPS must retain such data 
and information for a period of 10 years from the end the MIPS 
Performance Period.
    Finally, we indicated in the CY 2017 Quality Payment Program final 
rule, that, in addition to recouping any incorrect payments, we intend 
to use data validation and audits as an educational opportunity for 
MIPS eligible clinicians and groups and we note that this process will 
continue to include education and support for MIPS eligible clinicians 
and groups selected for an audit.
    The following is a summary of the public comments received on the 
``Data Validation And Auditing'' proposals and our responses:
    Comment: One commenter supported CMS' proposals regarding data 
validation and auditing requirements.
    Response: We thank the commenter for their support.
    Comment: Several commenters expressed concern regarding CMS's 
proposal to codify the requirement that eligible clinicians and groups 
must retain data utilized for reporting under MIPS for a period of 10 
years from the end of the MIPS performance period. A few commenters 
noted the 10-year retention requirement is excessive, and will create 
undue financial and time burden for eligible clinicians associated with 
managing, storing, and retrieving data for audit. Some of these 
commenters also noted the 10-year retention requirement is inconsistent 
with data retention requirements for other CMS programs, such as the 
EHR Incentive Program, the record retention requirements for non-
Quality Payment Program Part B payments, the rules governing CMS's 
Recovery Audit Contractors, and state laws on medical records 
retention. As a result, using a 10-year retention period would create 
multiple disparate data retention requirements for eligible clinicians 
participating in MIPS. A few commenters also asserted using the outer 
limit of False Claims Act liability as the data retention requirement 
for MIPS is inappropriate because the False Claims Act relates to 
instances where a party knowingly files a false claim for payment, and 
therefore, is an unduly burdensome and inappropriate baseline for data 
retention policies in a quality program. A few commenters therefore 
recommended CMS reduce the record retention policy to 3 years, as the 
commenters stated it is comparable to rules for CMS' Recovery Audit 
Contractors and it would allow eligible clinicians to retain the 
performance year data that would be used for payment adjustments. 
Whereas other commenters recommended using a 6-year retention period, 
stating that it would be similar to the requirements under the EHR 
Incentive Program. Two commenters specifically recommended adopting a 
5-year retention period, with one commenter noting state law record 
retention rules which use a 5 to 7-year record retention time period.
    Response: We appreciate the commenters' concerns and suggestions to 
reduce the record retention period. We understand concerns regarding 
the financial and time burdens associated with retaining data and 
information. Therefore, we are modifying our proposed record retention 
policy at Sec.  414.1390(d) to require all MIPS eligible clinicians and 
groups that submit data and information to CMS for purposes of MIPS to 
retain such data and information for a period of 6 years from the end 
of the performance period. We believe our final 6-year record retention 
requirement reduces burden and cost on MIPS eligible clinicians and 
groups and, is consistent with HIPAA record retention requirements and 
other Medicare program requirements.
    Comment: Several commenters requested additional guidance regarding 
the specific data eligible clinicians and groups must retain for 
auditing purposes and who should be responsible for retaining this 
data. A few commenters urged CMS to further specify the data retention 
required for auditing purposes prior to the beginning of the 
performance period so eligible clinicians and groups have adequate 
notice of what is expected of and required from them. One commenter 
specifically requested additional information regarding what evidence 
an eligible clinician should retain to support attestations, and 
encouraged CMS to provide eligible clinicians additional education 
regarding their data retention responsibilities. Another commenter 
requested clarification on whether the data retention requirements 
apply to third-party entities who submit data to CMS on behalf of 
eligible clinicians.
    Response: MIPS eligible clinicians and groups are responsible for 
retaining data. Please note, in the CY 2017 Quality Payment Program 
final rule, we required at Sec.  414.1390(a)(1) that MIPS eligible 
clinicians and groups must provide all data as requested by CMS or its 
designated entity, and at Sec.  414.1390(a)(2) that MIPS eligible 
clinicians and groups must provide substantive, primary source 
documents as requested. Such documents may include: Copies of claims, 
medical records for applicable patients, or other resources used in the 
data calculations for MIPS measures, objectives, and activities; and 
verification of records for Medicare and non-Medicare beneficiaries 
where applicable. We will continue providing clarification through 
subregulatory guidance. We also encourage MIPS eligible clinicians and 
groups to review the current guidance available on the Quality Payment 
Program Web site at https://qpp.cms.gov/docs/QPP_MIPS_Data_Validation_Criteria.zip.
    Additionally, we note that the certification policy we finalized in 
the CY 2017 Quality Payment Program final rule (81 FR 77362) and 
proposed to codify at Sec.  414.1390(b) in the CY 2017 Quality Payment 
Program proposed rule (82 FR 30254), requires MIPS eligible clinicians 
and groups to certify to the best of their knowledge that the data 
submitted to CMS is true, accurate, and complete. Thus, the evidence 
needed to support such an assertion would be the types of data and 
information we would request under Sec.  414.1390. Finally, we refer 
readers to section II.C.10.g. of this final rule with comment period 
where we discuss the record retention policy for third party 
intermediaries. This policy is found at Sec.  414.1400(j)(2), which we 
proposed to update in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30255).
    Comment: A few commenters provided specific recommendations 
regarding CMS' auditing process for MIPS data, focusing on the need for 
a process that is not excessively burdensome for eligible clinicians 
and provides sufficient time to respond to auditing requests in light 
of eligible clinicians' patient care obligations and resource 
availability. One commenter specifically recommended CMS establish an 
ombudsman for the sole purpose of monitoring and responding to eligible 
clinicians' complaints and concerns regarding the burden associated 
with audits. Another commenter recommended CMS develop a process to 
protect eligible clinicians' rights and offer recourse for eligible 
clinicians in instances where there are

[[Page 53806]]

issues with third-party intermediaries retaining data on their behalf. 
A third commenter requested CMS establish a fair and transparent 
auditing process with clear documentation requirements and data 
validation criteria for each MIPS category in order to lower the 
likelihood of misinterpretation by eligible clinicians and groups.
    Response: We believe the audit process established is reasonable 
and is no more burdensome than other existing Medicare audit processes, 
which similarly require providers and suppliers to furnish 
documentation to support the accuracy of previous statements made to 
CMS. We do not believe an ombudsman is necessary, but we will closely 
monitor concerns from MIPS eligible clinicians and groups regarding 
audit burdens and third-party intermediary issues. We believe that MIPS 
eligible clinicians and groups should incorporate appropriate 
protections into their agreements with third party intermediaries. 
Additionally, in regards to establishing a fair and transparent 
auditing process, we refer readers to our response above and reiterate 
that we believe Sec.  414.1390(a) sets forth what must be retained for 
purposes of an audit. We will continue providing clarification through 
subregulatory guidance.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal as proposed to add a new paragraph (b) to Sec.  
414.1390 that requires all MIPS eligible clinicians and groups that 
submit data and information to CMS for purposes of MIPS to certify to 
the best of their knowledge that the data submitted to CMS is true, 
accurate, and complete. Further, we finalize that the certification by 
the MIPS eligible clinician or group must accompany the submission and 
be made at the time of the submission. We are also finalizing with 
clarification our proposal to revise Sec.  414.1390 to add a new 
paragraph (c). Specifically, we are clarifying that we may reopen and 
revise a MIPS payment adjustment rather than a payment determination. 
Thus, we are finalizing our proposal to add a new paragraph (c) at 
Sec.  414.1390 that states we may reopen and revise a MIPS payment 
adjustment in accordance with the rules set forth at Sec. Sec.  405.980 
through 405.986. Finally, we are finalizing our proposal with 
modification to revise Sec.  414.1390 to add a new paragraph (d) 
stating that all MIPS eligible clinicians and groups that submit data 
and information to CMS for purposes of MIPS must retain such data and 
information for 6 years from the end of the MIPS performance period.
10. Third Party Data Submission
a. Generally
    Flexible reporting options will provide eligible clinicians with 
options to accommodate different practices and make measurement 
meaningful. We believe that allowing eligible clinicians to participate 
in MIPS through the use of third party intermediaries that will collect 
or submit data on their behalf, will help us accomplish our goal of 
implementing a flexible program. We strongly encourage all third party 
intermediaries to work with their MIPS eligible clinicians to ensure 
the data submitted are representative of the individual MIPS eligible 
clinician's or group's overall performance for that measure or 
activity.
    We use the term third party to refer to a qualified registry, QCDR, 
a health IT vendor, or other third party that obtains data from a MIPS 
eligible clinician's Certified Electronic Health Record Technology, or 
a CMS approved survey vendor. We refer readers to the CY 2017 Quality 
Payment Program final rule (81 FR 77363) and Sec.  414.1400 of the CFR 
for our previously established policies regarding third party 
intermediaries.
(1) Expansion to Virtual Groups
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30158), 
we proposed to allow third party intermediaries to also submit on 
behalf of virtual groups. We proposed to revise Sec.  414.1400(a)(1) to 
state that MIPS data may be submitted by third party intermediaries on 
behalf of an individual MIPS eligible clinician, group, or virtual 
group. We also refer readers to section II.C.4. of this final rule with 
comment period for a detailed discussion about virtual groups.
(2) Certification
    Additionally, we believe it is important that the MIPS data 
submitted by third party intermediaries is true, accurate, and 
complete. To that end, in the CY 2018 Quality Payment Program proposed 
rule (82 FR 30158), we proposed to add a requirement at Sec.  
414.1400(a)(5) stating that all data submitted to CMS by a third party 
intermediary on behalf of a MIPS eligible clinician, group or virtual 
group must be certified by the third party intermediary to the best of 
its knowledge as true, accurate, and complete. We also proposed that 
this certification accompany the submission and be made at the time of 
the submission. We solicited comments on these proposals.
    Below is a summary of the public comments received on our proposals 
to: (1) Allow third party intermediaries to also submit on behalf of 
virtual groups; (2) require that all data submitted to us by a third 
party intermediary on behalf of a MIPS eligible clinician, group, or 
virtual group must be certified by the third party intermediary to the 
best of its knowledge as true, accurate, and complete; and (3) require 
that this certification occur at the time of the submission and 
accompany the submission.
    Comment: One commenter supported the proposal to permit third-party 
intermediaries to submit data on behalf of not only individual eligible 
clinicians and groups, but also on behalf of virtual groups.
    Response: We thank the commenter for their support.
    Comment: One commenter supported the proposal that third-party 
intermediaries submitting data on behalf of a MIPS eligible clinician, 
group, or virtual group must certify and attest that the data are true, 
accurate, and complete at the time of submission but recommended that 
CMS define ``true, accurate, and complete.'' One commenter expressed 
concern that the term ``true, accurate, and complete'' is too vague, 
particularly the ``complete'' element; that because the third parties 
act as an intermediary and are not the original source of data means it 
is not reasonable to request that they certify to that criteria; and 
that because MIPS eligible clinicians themselves are the source of some 
of the information, data being attested to would be burdensome to 
verify. The commenter recommended studying data quality, possibly 
through a task force made up of all stakeholders engaged in this 
process because they suspect that standard checks of the quality of 
information retention from source to intermediary could be devised, but 
it should be done in a deliberative manner that leaves all constituents 
comfortable with the recommended process and requirements. One 
commenter also recommended that the certification requirement occur not 
with each individual submission, but rather on a registry level; and 
that individual practices or registries should not be punished if the 
attestation is found to be incorrect.
    Response: We appreciate the commenter's recommendations. The 
``true, accurate, and complete'' standard is used throughout the 
Medicare program and is commonly used in Medicare certifications. We do 
not believe that it is ambigious or vague. Additionally, we understand 
that third

[[Page 53807]]

party intermediaries may not always be the original source of data. In 
the CY 2017 Quality Payment Program final rule with comment period (81 
FR 77388), we clarified that MIPS eligible clinicians are ultimately 
responsible for the data that is submitted by their third party 
intermediary and expect that MIPS eligible clinicians and groups should 
ultimately hold their third party intermediary accountable for accurate 
reporting. However, we also expect third party intermediaries to 
develop processes to ensure that the data and information they submit 
to us on behalf of MIPS eligible clinicians, groups, and virtual groups 
is true, accurate, and complete. We rely on the third party 
intermediaries to address these issues in its arrangements and 
agreements with other entities, including MIPS eligible clinicians, 
groups, and virtual groups. We thank the commenter for their 
recommendation to develop a task force and will take this into 
consideration as we develop future policy. Additionally, we thank the 
commenter for their recommendation that the certification requirement 
be at the registry level. However, we are clarifying that the third 
party intermediary must certify each submission and that the 
certification must be for each MIPS eligible clinician, group, and 
virtual group on whose behalf it is submitting data to us. Finally, a 
third party intermediary that knowingly submits false data to the 
government, whether the third party intermediary was the original 
source of the data or not, would be subject to penalty under federal 
law.
    Comment: One commenter did not support the proposal that all data 
must be certified by the third party intermediary because the commenter 
believed the current regulations and attestations are adequate and 
broadening the attestation without providing guidance to third party 
intermediaries on how they can confidently make such an expansive 
assertion is not reasonable.
    Response: This certification requirement is not duplicative of 
current requirements nor is it an expansive assertion. Rather, it is a 
change for consistency across the program, that all data submissions 
are certified by the one who submitted it. We do not believe the 
certification requirement at Sec.  414.1400(a)(5) is an expansive 
assertion because the third party intermediary is certifying to the 
best of their knowledge that the data it submits is true, accurate, and 
complete. The certification we are requiring at Sec.  414.1400(a)(5) is 
imposed upon a third party intermediary and the data it submits to CMS 
on behalf of an individual MIPS eligible clinician, group, or virtual 
groups, while the certification requirement we finalized in the CY 2017 
QPP Final Rule (81 FR 77362) is imposed upon MIPS eligible clinicians 
and groups that submit data and information to CMS for purposes of 
MIPS. We believe it is important that all MIPS data submitted to CMS, 
whether it is submitted by MIPS eligible clinicians, groups, virtual 
groups, or a third party intermediary on behalf of MIPS eligible 
clinicians, groups, or virtual groups, be certified as true, accurate, 
and complete. Thus, we believe both certifications are necessary. 
Moreover, we do not believe additional guidance is needed, we believe 
that this requirement provides sufficent guidance for third party 
intermediaries to execute this certification requirement in a manner 
that is feasible in their business operations while remaining compliant 
with requirements of the policy. We also refer readers to our response 
to the previous comment for additional discussion.
    Final Action: After consideration of the public comments received, 
we are finalizing our proposals, as proposed: (1) To revise Sec.  
414.1400(a)(1) to include virtual groups; and (2) that we will require 
at Sec.  414.1400(a)(5) that all data submitted to CMS by a third party 
intermediary on behalf of a MIPS eligible clinician, group or virtual 
group must be certified by the third party intermediary to the best of 
its knowledge as true, accurate, and complete; and require that this 
certification occur at the time of the submission and accompany the 
submission.
b. Qualified Clinical Data Registries (QCDRs)
    In the CY 2017 Quality Payment Program final rule (81 FR 77364), we 
finalized the definition and capabilities of a QCDR. We finalized to 
require other information (described below) of QCDRs at the time of 
self-nomination. As previously established, if an entity becomes 
qualified as a QCDR, they will need to sign a statement confirming this 
information is correct prior to listing it on our Web site (81 FR 
77363). Once we post the QCDR on our Web site, including the services 
offered by the QCDR, we will require the QCDR to support these services 
and measures for its clients as a condition of the entity's 
participation as a QCDR in MIPS (81 FR 77366). Failure to do so will 
preclude the QCDR from participation in MIPS in the subsequent year (81 
FR 77366). In the CY 2018 Quality Payment Program proposed rule (82 FR 
30159), we did not propose any changes to the definition or the 
capabilities of a QCDR. However, we did propose changes to the self-
nomination process and the QCDR measure nomenclature. Additionally, we 
proposed a policy in which a QCDR may support an existing QCDR measure 
that is owned by another QCDR. The details of these proposals are 
discussed in more detail below.
(1) Establishment of an Entity Seeking To Qualify as a QCDR
    In the CY 2017 Quality Payment Program final rule (81 FR 77365), we 
finalized the criteria to establish an entity seeking to qualify as a 
QCDR. In the CY 2018 Quality Payment Program proposed rule (82 FR 
30159), we did not propose any changes to the criteria and refer 
readers to the CY 2017 Quality Payment Program final rule for the 
criteria to qualify as a QCDR.
(2) Self-Nomination Process
(a) Generally
    In the CY 2017 Quality Payment Program final rule (81 FR 77365 
through 77366), we finalized procedures and requirements for QCDRs to 
self-nominate. Additional details regarding self-nomination 
requirements for both the self-nomination form and the QCDR measure 
specification criteria and requirements can be found in the QCDR fact 
sheet and the self-nomination user guide, that are posted in the 
resource library of the Quality Payment Program Web site at https://qpp.cms.gov/about/resource-library.
    In the CY 2017 Quality Payment Program final rule (81 FR 77365 
through 77366), we finalized the self-nomination period for the 2017 
performance period to begin on November 15, 2016, and end on January 
15, 2017. We also finalized for future years of the program, beginning 
with the 2018 performance period, for the self-nomination period to 
begin on September 1 of the year prior to the applicable performance 
period until November 1 of the same year. As an example, the self-
nomination period for the 2018 performance period will begin on 
September 1, 2017, and will end on November 1, 2017. We believe an 
annual self-nomination process is the best process to ensure accurate 
information is conveyed to MIPS individual eligible clinicians and 
groups and accurate data is submitted for MIPS. Having qualified as a 
QCDR in a prior year does not automatically qualify the entity to 
participate in MIPS as a QCDR in subsequent performance periods (82 FR 
30159). As discussed in the CY 2017 Quality Payment Program final rule 
(81 FR 77365), a QCDR may chose not to continue participation in the 
program in

[[Page 53808]]

future years, or may be precluded from participation in a future year 
due to multiple data or submission errors. QCDRs may also want to 
update or change the measures, services or performance categories they 
intend to support (82 FR 30159). Thus, we require that QCDRs must self-
nominate each year, and note that the prior performance of the QCDR 
(when applicable) is taken into consideration in approval of their 
self-nomination for subsequent years (82 FR 30159). In this final rule, 
we are establishing a simplified self-nomination process for existing 
QCDRs in good standing, beginning with the CY 2019 performance period.
(b) Simplified Self-Nomination Process for Existing QCDRs in MIPS, That 
Are in Good Standing
    We do understand that some QCDRs may not have any changes to the 
measure and/or activity inventory they offer to their clients, and 
intend to participate in the MIPS for many years. In the CY 2018 
Quality Payment Program proposed rule (82 FR 30159), we proposed 
beginning with the 2019 performance period, a simplified self-
nomination process, to reduce the burden of self-nomination for those 
existing QCDRs that have previously participated in MIPS and are in 
good standing (not on probation or disqualified, as described below), 
and to allow for sufficient time for us to review data submissions and 
make determinations. Our proposals to simplify the process for QCDRs in 
good standing with no changes, minimal changes, and those with 
substantive changes are discussed below.
(i) Existing QCDRs in Good Standing With No Changes
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30159), 
we proposed, beginning with the 2019 performance period, a simplified 
process for which existing QCDRs in good standing may continue their 
participation in MIPS, by attesting that the QCDR's previously 
approved: Data validation plan, services offered, cost associated with 
using the QCDR, measures, activities, and performance categories 
supported in the previous year's performance period of MIPS have no 
changes and will be used for the upcoming performance period. 
Specifically, existing QCDRs in good standing with no changes may 
attest during the self-nomination period, between September 1 and 
November 1, that they have no changes to their approved self-nomination 
application from the previous year of MIPS. By attesting that all 
aspects of their approved application from the previous year have not 
changed, these existing QCDRs in good standing would be spending less 
time completing the entire self-nomination form, as was previously 
required on a yearly basis.
(ii) Existing QCDRs in Good Standing With Minimal Changes
    Beginning with the 2019 performance period, existing QCDRs in good 
standing that would like to make minimal changes to their previously 
approved self-nomination application from the previous year, may submit 
these changes, and attest to no other changes from their previously 
approved QCDR application, for CMS review during the self-nomination 
period, from September 1 to November 1. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30159), we proposed that minimal changes 
include: Limited changes to their performance categories, adding or 
removing MIPS quality measures, and adding or updating existing 
services offered, and/or the cost associated with using the QCDR.
(iii) Existing QCDRs in Good Standing With Substantive Changes
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30159) 
we stated that existing QCDRs in good standing, may also submit for CMS 
review and approval, substantive changes to measure specifications for 
existing QCDR measures that were approved the previous year, or submit 
new QCDR measures for CMS review and approval without having to 
complete the entire self-nomination application process, which is 
required to be completed by a new QCDR. By attesting that certain 
aspects of their approved application from the previous year have not 
changed, existing QCDRs in good standing would be spending less time 
completing the entire self-nomination form, as was previously required 
on a yearly basis. We are proposing such a simplified process to reduce 
the burden of self-nomination for those existing QCDRs who have 
previously participated in MIPS, and are in good standing (not on 
probation or disqualified, as described later in this section) and to 
allow for sufficient time for us to review data submissions and to make 
determinations on the standing of the QCDRs. We note that substantive 
changes to existing QCDR measure specifications or any new QCDR 
measures would have to be submitted for CMS review and approval by the 
close of the self-nomination period. This proposed process will allow 
existing QCDRs in good standing to avoid completing the entire 
application annually, as is required in the existing process, and in 
alignment with the existing timeline. We requested comments on this 
proposal.

(A) Multi-Year Approval of QCDRs

    In the development of the above policy, we had also reviewed the 
possibility of offering a multi-year approval, in which QCDRs would be 
approved for a continuous 2-year increment of time. However, we are 
concerned that utilizing a multi-year approval process would restrict 
QCDRs by having them support the same fixed services they had for the 
first year, and would not provide QCDRs with the flexibility to add or 
remove services, measures, and/or activities based on their QCDR 
capabilities for the upcoming program year. Furthermore, under a multi-
year approval process, QCDRs would not be able to make changes to their 
organizational structure (as described above) and would also create 
complications in our process for placing QCDRs who perform poorly 
(during the first year) on probation or disqualifying them (as 
described below). Moreover, a multi-year approval process would not 
take into consideration potential changes in criteria or requirements 
of participation for QCDRs, that may occur as the MIPS program develops 
through future program years. For the reasons stated above, we believe 
an annual self-nomination period is appropriate. We understand that 
stakeholders are interested in a multi-year approval process, for that 
reason we intend to revisit the topic once we have gained additional 
experience with the self-nomination process under MIPS. We seek comment 
from stakeholders as to how they believe our aforementioned concerns 
with multi-year approvals of QCDRs can be resolved.

(B) Web-Based Submission of Self-Nomination Forms

    In the CY 2018 Quality Payment Program proposed rule (82 FR 30159), 
for the 2018 performance period and beyond, we proposed that self-
nomination information must be submitted via a web-based tool, and to 
eliminate the submission method of email. We noted that we will provide 
further information about the web-based tool at www.qpp.cms.gov.
    Below is a summary of the public comments received on the following 
proposals: (1) A simplified self-nomination process for existing QCDRs 
in good standing; and (2) To eliminate the self-nomination submission 
method of email.

[[Page 53809]]

    Comment: Many commenters supported the proposal allowing a 
simplified self-nomination process for QCDRs in good standing to 
continue their participation in MIPS by attesting to certain 
information, for reasons including: It would require less time to 
complete the self-nomination application; it would minimize confusion 
and miscommunication with CMS; it should enable CMS to dedicate more 
time to the review of the QCDR measures; it would help reduce reporting 
burden for QCDRs; it will encourage the use and development of QCDR; it 
will allow for more time to be spent developing new measures; and 
decreasing application burden will enhance their ability to assist 
clients with quality improvement and data submission and may create 
efficiency by encouraging registries to make many measure changes at 
one time versus submitting small changes annually.
    Response: We thank commenters for their support with regards to a 
simplified self-nomination process for existing QCDRs in good standing 
beginning with the 2019 performance period.
    Comment: One commenter recommended simplifying the QCDR self-
nomination process by de-coupling the QCDR self-nomination and measure 
selection processes. One commenter recommended that CMS make exception 
to this proposal to allow a QCDR to replace a measure if deems 
necessary. One commenter recommended that the self-nomination could be 
used if QCDR measures changes because they believed that QCDR measure 
changes should be considered independent of the self-nomination 
process. One commenter recommended that CMS consider self-populating 
self-nomination forms based on the previous application. One commenter 
recommended that CMS consider a system under which QCDRs only need to 
reapply if they make substantial organizational or operational changes.
    Response: We recognize that the existing process and our proposals 
could use additional clarification. The existing process for QCDR self-
nomination and QCDR measure approval is a two-part process. The QCDR 
self-nomination form requires contact information, services, costs 
associated with using the QCDR, performance categories supported, MIPS 
quality measures, and data validation plan to be considered for the 
next performance period (82 FR 30159). Currently, QCDRs may also submit 
for consideration QCDR measures (previously referred to as non-MIPS 
measures (81 FR 77375) and separate from MIPS quality measures) as a 
part of their self-nomination, which are reviewed and approved or 
rejected separately from the self-nomination form. MIPS quality 
measures have gone through extensive review prior to rulemaking and are 
approved or rejected for inclusion in the program through the rule-
making cycle as discussed in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30043-30045). QCDR measures, on the other hand, 
are reviewed for consideration under a different timeline and must be 
reviewed to the extent needed to determine whether they are appropriate 
for inclusion in the program, and align within the goals of the MIPS 
program and provide meaningful measurement to eligible clinicians and 
groups (82 FR 30160 through 30161). Details regarding self-nomination 
requirements for both the self-nomination form and the QCDR measure 
specification criteria and requirements can be found in the QCDR fact 
sheet and the self-nomination user guide, that are posted in the 
resource library of the Quality Payment Program Web site at https://qpp.cms.gov/about/resource-library.
    Under our proposals, we are clarifying that beginning with the 2019 
performance period, we are clarifying that any previously approved QCDR 
in good standing (meaning, those that are not on probation or 
disqualified) that wishes to self nominate using the simplified process 
can attest, in whole or in part, that their previously approved form is 
still accurate and applicable. Specifically, under this process, QCDRs 
with no changes can attest that their previously submitted QCDR self-
nomination form in its entirety remains the same. Similarly, previously 
approved QCDRs in good standing that wish to self nominate using the 
simplified process and have minimal changes can attest to aspects of 
their previously submitted form that remain the same, but would 
additionally be required to update the self-nomination form to reflect 
any minimal changes for CMS review. As stated in our proposal above, 
minimal changes include, but are not limited to: Limited changes to 
performance categories, adding or removing MIPS quality measures, and 
adding or updating existing services and/or cost information.
    Furthermore, under our proposal, we are also clarifying that any 
previously approved QCDR in good standing that wishes to self nominate 
using the simplified process and has substantive changes may submit 
those substantive changes while attesting that the remainder of their 
application remains the same from the previous year. We are clarifying 
here that substantive changes include, but are not limited to: Updates 
to existing (approved) QCDR measure specifications, new QCDR measures 
for consideration, changes in the QCDR's data validation plan, or 
changes in the QCDR's organizational structure (for example, if a 
regional health collaborative or specialty society wishes to partner 
with a different data submission platform vendor that would support the 
submission aspect of the QCDR). This process mirrors that for minimal 
changes. For example, if a previously approved QCDR in good standing 
would like to submit changes only to it's QCDR measures, the QCDR can 
attest that there are no changes to their self-nomination form, and 
provide the updated QCDR measures specifications for CMS review and 
approval. We are also clarifying that the information required to be 
submitted for any changes would be the same as that required under the 
normal self-nomination process. We refer reader to the CY 2017 Quality 
Payment Program final rule (81 FR 77366 through 77367), as well as (81 
FR 77374 through 77375) and Sec.  414.1400(f). For example, if a QCDR 
would like to include one new QCDR measure, it would be required to 
submit: Descriptions and narrative specifications for each measure, the 
name or title of the QCDR measure, NQF number (if NQF endorsed), 
descriptions of the denominator, numerator, denominator exceptions 
(when applicable), denominator exclusions (when applicable), risk 
adjustment variables (when applicable), and risk adjustment algorithms. 
We expect that the measure will address a gap in care, and prefer 
outcome or high priority measures. Documentation or ``check box'' 
measures are discouraged. Measures that have a very high performance 
rate already, or extremely rare gaps in care will unlikely be approved 
for inclusion (81 FR 77374 through 77375).
    We disagree with the recommendation that QCDRs only need to reapply 
if they make substantial organization or operational changes. This 
would not take into consideration potential changes in criteria or 
requirements of participation for QCDRs, as the MIPS program develops 
through future program years. Furthermore, we believe self-nomination 
should occur on an annual basis to account for QCDRs that may perform 
poorly and thereby need to be placed on probation or precluded from 
participation the following year. We thank the commenter for their

[[Page 53810]]

suggestion of automatically self-nomination forms based off of the 
previous year's application; we are looking into the technical 
capabilities of the system, and will make any potential updates based 
on the feasibility of the system for future self-nomination form 
updates.
    Comment: One commenter recommended that in light of Congressional 
intent to encourage the use of QCDRs, CMS should not only simplify the 
process for re-approval of QCDRs, but should also consider 
substantially streamlining and simplifying the process for approval of 
new QCDRs. The commenter suggests including a revision or elimination 
of any requirement that the Scientific Registry for Transplant 
Recipients (SRTR) must report quality performance on an individual 
level in order to be approved as a QCDR.
    Response: As indicated in the CY 2017 Quality Payment Program final 
rule (81 FR 77363) the Secretary encourages the use of QCDRs in 
carrying out MIPS. We believe the current self-nomination application 
for new QCDRs is comprehensive and collects information needed to make 
a determination as to whether the entity has or has not met the 
requirements and criteria of participation as a QCDR under MIPS. We 
believe that this simplified self-nomination policy will help us 
streamline the existing self-nomination process. As a requirement, 
QCDRs must support reporting under the quality performance category at 
the individual and/or group level (81 FR 77368).
    Comment: A few commenters expressed concern with the current QCDR 
self-nomination process for reasons including inconsistent feedback, 
impractical timelines, and a lack of rationale for rejected measures. A 
few commenters recommended that QCDR self-nomination application and 
materials should be updated to outline all of the information needed to 
determine QCDR status to avoid delays and misunderstandings. A few 
commenters recommended that CMS develop a standardized process for 
reviewing QCDR measures, including structured timeframes for an initial 
review period, an appeals process, and a final review. One commenter 
also recommended mechanisms to ensure transparency and predictability, 
assigning a coordinator for each QCDR and creating an official database 
containing decisions on measures to ensure there are no conflicting 
messages.
    Response: We refer readers to our previous response in this final 
rule with comment period, in which we clarify that the existing process 
for QCDR self-nomination and QCDR measure approval is a two-part 
process. To reiterate, the QCDR self-nomination form requires contact 
information, services, costs associated with using the QCDR, 
performance categories supported, MIPS quality measures, and data 
validation plan to be considered for the next performance period (82 FR 
30159). Currently, QCDRs may also submit for consideration QCDR 
measures (previously referred to as non-MIPS measures (81 FR 77375) and 
separate from MIPS quality measures) as a part of their self-
nomination, which are reviewed and approved or rejected separately from 
the self-nomination form. MIPS quality measures have gone through 
extensive review prior to rulemaking and are approved or rejected for 
inclusion in the program through the rulemaking cycle as discussed in 
the CY 2018 Quality Payment Program proposed rule (82 FR 30043-30045). 
QCDR measures, on the other hand, are reviewed for consideration under 
a different timeline and must be reviewed to the extent needed to 
determine whether they are appropriate for inclusion in the program, 
and align within the goals of the MIPS program and provide meaningful 
measurement to eligible clinicians and groups (82 FR 30160 through 
30161). Details regarding self-nomination requirements for both the 
self-nomination form and the QCDR measure specification criteria and 
requirements can be found in the QCDR fact sheet and the self-
nomination user guide, that are posted in the resource library of the 
Quality Payment Program Web site at https://qpp.cms.gov/about/resource-library.
    We understand the commenters concerns, but would like to note we 
have been working to implement process improvements and develop 
additional standardization for the 2018 performance period self-
nomination and QCDR measure review, in which consistent feedback is 
communicated to vendors, additional time is given to vendors to respond 
to requests for information, and more detailed rationales are provided 
for rejected QCDR measures. Furthermore, through our review, we intend 
to communicate the timeframe in which a decision re-examination can be 
requested should we reject QCDR measures. In order to improve 
predictability and avoid delays or misunderstandings, we have made 
updates to the self-nomination form to outline all of the information 
needed during the review process. We refer readers to: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html where additional self-nomination guidance can be found. 
Furthermore, we intend to assign specific personnel to communicate 
self-nomination and QCDR decisions as appropriate and will continue to 
use our internal decision tracker to track all decisions made on QCDRs 
and their QCDR measures, as we did during the review of 2017 self-
nominations and QCDR measures. We appreciate that commenters provided 
recommendations to standardize a process and timeframe for self-
nomination review and will take them into consideration for future 
policies. We are currently working through such efforts to standardize 
the process and timelines to the best of our ability.
    Comment: One commenter appreciated the adjusted timeline that ends 
on November 1, but expressed concern about the feasibility of this 
timeline because the commenter believed QCDRs will have less than a 
full year's worth of data to evaluate when making decisions about 
whether to retire or modify existing measures for the upcoming year. 
The commenter requested that CMS adopt a multi-year measure approval 
process, such as 5 years, to allow QCDRs to adjust or retire a QCDR 
measure from year-to-year, as long as they request such changes by 
CMS's self-nomination deadline so QCDRs would not be expected to invest 
time and resources on defending their measures from year to year and 
could instead shift their focus to more meaningful analytics to help 
improve patient care. A few commenters that supported the simplified 
process also expressed concerns about the timelines for the self-
nomination process and ability to update or change information given 
that they will not have a full year of data by the deadline.
    Response: We appreciate the commenters support regarding the change 
in the self-nomination period timeline. We understand that that there 
is concern around the timeline as QCDRs believe they will have less 
than a full year's worth of data to evaluate prior to making decisions 
about whether to retire or modify an existing QCDR measure before the 
next self-nomination period. We acknowledge that the timeframe may, in 
some instances, limit the QCDR's ability to make a determination about 
changing or retiring their QCDR measure, however we heard 
overwhelmingly from stakeholders in the CY 2017 Quality Payment Program 
final rule, that having the ability to make their quality measure 
selections

[[Page 53811]]

prior to the beginning of the performance period is critical. CMS will 
review the measure, data submissions and performance data (as 
available) to ensure that the measure is appropriate for inclusion. We 
will also take into consideration whether or not the measure is topped 
out, reflects current clinical guidelines and is not considered 
standard of care prior to making a final determination on the QCDR 
measure. We refer readers to Sec.  414.1400(f) for additional 
information. Furthermore, as stated in our proposal, we are concerned 
that utilizing a multi-year approval process would restrict QCDRs by 
having them support the same fixed services they had for the first 
year, and would not provide QCDRs with the flexibility to add or remove 
services, measures, and/or activities based on their QCDR capabilities 
for the upcoming program year. Moreover, a multi-year approval process 
would not take into consideration potential changes in criteria or 
requirements of participation for QCDRs. Furthermore, our concerns with 
multi-year approval of QCDR measures stem from the possibility of 
clinical guidance changes, that may include the addition, removal, or 
update to a new class of medications, procedures, diagnosis codes (for 
example, ICD-10 code updates), or treatment methodology. Thus, at this 
time, we believe an annual self-nomination and QCDR measure approval 
process is most appropriate. We will however take such recommendations 
into consideration, for future years as we gain further experience with 
QCDRs and QCDR measures under MIPS.
    Comment: One commenter supported the registry self-nomination 
period deadline of November 1, 2017, because they believed with this 
deadline, CMS will be able to better accommodate registries, other 
third-party intermediaries, and eligible clinicians and groups as they 
implement and prepare for MIPS reporting each year. The commenter 
recommended that CMS approve 2018 QCDR measure specifications by 
December 1, 2017, to allow for adequate time to prepare for the 2018 
performance year.
    Response: We interpret the comment to refer to QCDRs and thank the 
commenter for its support. We intend to have QCDR measure specification 
approvals and/or rejections completed by early December.
    Comment: A few commenters supported CMS's proposal that beginning 
with the 2018 performance period, self-nomination information must be 
submitted via a web-based tool, rather than email, because they noted 
it will simplify the process, reduce the time to complete self-
nomination applications, and would minimize confusion and 
miscommunication with CMS.
    Response: We thank the commenters for their support and believe the 
web-based tool will help reduce burden and confusion.
    Comment: A few commenters recommended revising the application 
process to eliminate the duplication when applying as both a QCDR and 
qualified registry. One commenter also recommended eliminating 
duplicate applications for Qualified Registries and QCDRs because they 
believed a majority of the qualified registry questions were also on 
the QCDR application, and therefore, the application could be 
duplicated within the web portal.
    Response: We believe having distinct applications for QCDRs and 
Qualified Registries is important because each specifies specific 
measures, performance categories, and services offered by the entity. 
Though we understand that application questions are the same under the 
QCDR and Qualified Registries self-nomination applications, we note 
that QCDRs have additional capabilities as compared to Qualified 
Registries. QCDRs have the capability to develop and submit for 
consideration up to 30 QCDR measures for CMS review and approval. 
Furthermore, as defined in the CY 2017 Quality Payment Program final 
rule (81 FR 77366) for QCDR measures, if the measure is risk adjusted, 
the QCDR is required to provide us with details on their risk 
adjustment methodology (risk adjustment variables, and applicable 
calculation formula) at the time of self-nomination. However, we will 
take these comments into consideration as we develop future policy.
    Final Action: After consideration of the public comments received, 
we are finalizing our proposals with clarification. Specifically at 
Sec.  414.1400(b) we are finalizing our proposal, beginning with the 
2019 performance period, that previously approved QCDRs in good 
standing (that are not on probation or disqualified) that wish to self 
nominate using the simplified process can attest, in whole or in part, 
that their previously approved form is still accurate and applicable. 
We are clarifying our proposals by elaborating on what would be 
required for previously approved QCDRs in good standing that wish to 
self-nominate and have minimal or substantive changes. For abundant 
clarity, we are restating our finalized proposals with clarifications 
here:
    Beginning with the 2019 performance period, previously approved 
QCDRs in good standing (meaning, those that are not on probation or 
disqualified) that wishes to self nominate using the simplified process 
can attest, in whole or in part, that their previously approved form is 
still accurate and applicable. Specifically, under this process, QCDRs 
with no changes can attest that their previously submitted QCDR self-
nomination form in its entirety remains the same. Similarly, previously 
approved QCDRs in good standing that wish to self nominate using the 
simplified process and have minimal changes can attest to aspects of 
their previously submitted form that remain the same, but would 
additionally be required to outline any minimal changes for CMS review 
and approval. Minimal changes include, but are not limited to: Limited 
changes to performance categories, adding or removing MIPS quality 
measures, and adding or updating existing services and/or cost 
information. Furthermore, a previously approved QCDRs in good standing 
that wishes to self nominate using the simplified process and has 
substantive changes may submit those substantive changes while 
attesting that the remainder of their application remains the same from 
the previous year. Substantive changes include, but are not limited to: 
Updates to existing (approved) QCDR measure specifications, new QCDR 
measures for consideration, changes in the QCDR's data validation plan, 
or changes in the QCDR's organizational structure (for example, if a 
regional health collaborative or speciality society wishes to partner 
with a different data submission platform vendor that would support the 
submission aspect of the QCDR). We are also clarifying that the 
information required to be submitted for any changes would be the same 
as that required under the normal self-nomination process as discussed 
previously in this final rule with comment period.
    Furthermore, we are finalizing our proposal, as proposed, that 
beginning with the 2018 performance period, that self-nomination 
applications must be submitted via a web-based tool, and that the email 
method of submission will be eliminated.
    For the 2018 performance period and future performance periods, we 
are finalizing the following proposal: That self-nomination submissions 
will occur via a web-based tool rather than email; and for the 2019 
performance period and future performance periods, we are finalizing 
the availability of a simplified

[[Page 53812]]

self-nomination process for existing QCDRs in good standing.
(3) Information Required at the Time of Self-Nomination
    In the CY 2017 Quality Payment Program final rule (81 FR 77366 
through 77367), we finalized the information a QCDR must provide to us 
at the time of self-nomination. In the CY 2018 Quality Payment Program 
proposed rule (82 FR 30159 through 30160), we proposed to replace the 
term ``non-MIPS measures'' with ``QCDR measures'' for future program 
years, beginning with the 2018 performance period. We noted that 
although we proposed a change in the term referring to such measures, 
we did not propose any other changes to the information a QCDR must 
provide to us at the time of self-nomination under the process 
finalized in the CY 2017 Quality Payment Program final rule. We 
referred readers to the CY 2017 Quality Payment Program final rule for 
specific information requirements. However, we refer readers to section 
II.C,10,a,(5)(b) of this final rule with comment period, where we are 
modifying our proposal that as a part of the self-nomination review 
process for 2018 and future years, we will assign QCDR measure IDs to 
approved QCDR measures, and the same measure ID must be used by any 
other QCDRs that have received permission to also report the measure. 
We also note that information required under the newly finalized 
simplified process is discussed in the previous section of this final 
rule with comment period. Additionally, as finalized in section 
II.C.10.b.(2)(b)(iii) of this final rule with comment period, we will 
only accept self-nomination applications through the web-based tool and 
will provide additional guidance as to what information needs to be 
submitted for QCDR measure specifications through the 2018 Self-
Nomination User Guide that will be posted on our Web site.
    The following is a summary of the public comments received on the 
``Information Required at the Time of Self-Nomination'' proposal and 
our response:
    Comment: A few commenters supported the proposal that the term 
``QCDR measures'' replace the term ``non-MIPS measures'' for reasons 
including a belief that the term ``non-MIPS'' has caused confusion and 
created the impression that the measures are not eligible to be 
reported under the MIPS program when in fact they are.
    Response: We thank the commenters for their support.
    Comment: One commenter did not support the proposal to replace the 
term ``non-MIPS measure'' with ``QCDR measure'' noting that there is 
likely to be greater understanding and familiarity with the current 
terminology of ``non-MIPS measures.'' The commenter recommended that, 
instead, these measures could be referred to as ``non-MIPS (QCDR 
defined, specialty-specific) measures,'' ``non-MIPS (QCDR-specific) 
measures,'' or ``non-MIPS (QCDR-defined) measures'' to promote clarity 
for clinicians.
    Response: Although we understand the commenters perspective, that 
there is greater familiarity with the current terminology of ``non-MIPS 
measures'', we believe that the term may lead clinicians and groups new 
to MIPS to believe that the measures are not in the MIPS program and 
they may then chose not to report on measures developed by QCDRs. 
``QCDR measures'' will clearly construe that the measure is owned by a 
QCDR and avoid any misinterpretation that the measures are not 
reportable under MIPS. The term ``QCDR measure'', previously referred 
to as ``non-MIPS measure'' is used to identify measures that are 
developed by QCDRs. The term is used to distinguish them from the 
quality measures that are in the MIPS program that have been reviewed 
and approved through the rule making cycle. The term is used in the 
QCDR self-nomination form and in the QCDR qualified posting to identify 
which QCDR developed measures have been approved for use in the 
upcoming performance period.
    Final Action: After consideration of the public comments, we are 
finalizing as proposed, our proposal to replace the term ``non-MIPS 
measures'' with ``QCDR measures'' for future program years, beginning 
with the 2018 performance period. We have also updated the regulation 
text to reflect this change, and refer readers to Sec.  414.1400(e) for 
the updated language.
    For the 2018 performance period and future performance periods, we 
are finalizing the following proposal: That the term ``QCDR measures'' 
will replace the term ``non-MIPS measures''.
(4) QCDR Criteria for Data Submission
    In the CY 2017 Quality Payment Program final rule (81 FR 77367 
through 77374), we finalized that a QCDR must perform specific 
functions to meet the criteria for data submission. While we did not 
propose any changes to the criteria for data submission in the CY 2018 
Quality Payment Program proposed rule (82 FR 30160), we clarified the 
criteria for QCDR data submission. For data submissions, QCDRs:
     Must have in place mechanisms for transparency of data 
elements and specifications, risk models and measures. That is, we 
expect that the QCDR measures, and their data elements (that is, 
specifications) comprising these measures be listed on the QCDR's Web 
site unless the measure is a MIPS measure, in which case the 
specifications will be posted by us. QCDR measure specifications should 
be provided at a level of detail that is comparable to what is posted 
by us on the CMS Web site for MIPS quality measure specifications.
     Approved QCDRs may post the MIPS quality measure 
specifications on their Web site, if they so choose. If the MIPS 
quality measure specifications are posted by the QCDRs, they must be 
replicated exactly the same as the MIPS quality measure specifications 
as posted on the CMS Web site.
     Enter into and maintain with its participating MIPS 
eligible clinicians, an appropriate Business Associate Agreement that 
complies with the HIPAA Privacy and Security Rules. Ensure that 
Business Associate Agreement provides for the QCDR's receipt of 
patient-specific data from an individual MIPS eligible clinician or 
group, as well as the QCDR's disclosure of quality measure results and 
numerator and denominator data or patient specific data on Medicare and 
non-Medicare beneficiaries on behalf of MIPS eligible clinicians and 
groups.
     Must provide timely feedback at least 4 times a year, on 
all of the MIPS performance categories that the QCDR will report to us. 
We refer readers to section II.C.9.a. of the CY 2018 Quality Payment 
Program proposed rule for additional information on third party 
intermediaries and performance feedback.
     For purposes of distributing performance feedback to MIPS 
eligible clinicians, we encourage QCDRs to assists MIPS eligible 
clinicians in the update of their email addresses in CMS systems--
including PECOS and the Identity and Access System--so that they have 
access to feedback as it becomes available on www.qpp.cms.gov and have 
documentation from the MIPS eligible clinician authorizing the release 
of his or her email address.
    As noted in the CY 2017 Quality Payment Program final rule (81 FR 
77370), we will on a case-by-case basis allow QCDRs and qualified 
registries to request review and approval for additional MIPS measures 
throughout the performance period. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30160), we clarified and explained that 
this flexibility would

[[Page 53813]]

only apply for MIPS measures; QCDRs will not be able to request 
additions of any new QCDR measures throughout the performance period. 
Furthermore, QCDRs will not be able to retire any measures they are 
approved for during the performance period (82 FR 30160). Should a QCDR 
encounter an issue regarding the safety or change in evidence for a 
measure during the performance period, it must inform CMS by email of 
said issue and indicate whether it will or will not be reporting on the 
measure; we will review measure issues on a case-by-case basis (82 FR 
30160). Any measures QCDRs wish to retire would need to be retained 
until the next annual self-nomination process and applicable 
performance period (82 FR 30160).
(5) QCDR Measure Specifications Criteria
    In the CY 2017 Quality Payment Program final rule (81 FR 77374 
through 77375), we specified at Sec.  414.1400(f) that the QCDR must 
provide specific QCDR measures specifications criteria. We generally 
intend to apply a process similar to the one used for MIPS measures to 
QCDR measures that have been identified as topped out. In the CY 2018 
Quality Payment Program proposed rule (82 FR 30160), we did not propose 
any changes to the QCDR measure specifications criteria and refer 
readers to the CY 2017 Quality Payment Program final rule (81 FR 77374 
through 77375) for the specification requirements a QCDR must submit 
for each measure, activity, or objective the QCDR intends to submit to 
CMS. Though we did not make proposals around the QCDR measure 
specifications themselves, in the CY 2018 Quality Payment Program 
proposed rule, (82 FR 30160) we did make a number of clarifications 
around alignment with the measures development plan, previously retired 
measures, and the public posting of the QCDR measure specifications. 
Additionally, we proposed to allow QCDR vendors to seek permission from 
another QCDR to use an existing approved QCDR measure. Lastly, we 
sought comment from stakeholders around requiring QCDRs to fully 
develop and test their QCDR measures by the time of self-nomination. 
These are discussed in more detail below.
(a) Clarifications to Previously Established Policies
    In the CY 2017 Quality Payment Program final rule (81 FR 77375), we 
finalized that we will consider all QCDR (non-MIPS) measures submitted 
by the QCDR, but that the measures must address a gap in care and 
outcome or other high priority measures are preferred. In the CY 2018 
Quality Payment Program proposed rule (82 FR 30160), we clarified that 
we encourage alignment with our Measures Development Plan.\13\
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    \13\ The CMS Quality Measures Development Plan: Supporting the 
Transition to The Quality Payment Program 2017 Annual Report, 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2017-CMS-MDP-Annual-Report.pdf.
---------------------------------------------------------------------------

    In the CY 2017 Quality Payment Program final rule (81 FR 77375), we 
finalized that measures that have very high performance rates already 
or address extremely rare gaps in care (thereby allowing for little or 
no quality distinction between MIPS eligible clinicians) are also 
unlikely to be approved for inclusion. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30160), we also clarified that we will 
likely not approve retired measures that were previously in one of 
CMS's quality programs, such as the Physician Quality Reporting System 
(PQRS) program, if proposed as QCDR measures. This includes measures 
that were retired due to being topped out, as defined in section 
II.C.6.c.(2) of the CY 2018 Quality Payment Program proposed rule, due 
to high-performance or measures retired due to a change in the evidence 
supporting the use of the measure.
    Lastly, in the CY 2017 Quality Payment Program final rule (81 FR 
77375), we finalized that the QCDR must publicly post the measure 
specifications (no later than 15 days following our approval of these 
measure specifications) for each QCDR measure it intends to submit for 
MIPS. In the CY 2018 Quality Payment Program proposed rule (82 FR 
30160), we clarified that 15 days refers to 15 calendar days, not 
business days. The QCDR must publicly post the measure specifications 
no later than 15 calendar days following our approval of these measures 
specifications for each QCDR measure it intends to submit for MIPS. It 
is important for QCDRs to post their QCDR measure specifications on 
their Web site in a timely manner, so that the specifications are 
readily available for MIPS eligible clinicians and groups to access and 
review in determining which QCDR measures they intend to report on for 
the performance period.
(b) QCDRs Seeking Permission From Another QCDR To Use an Existing, 
Approved QCDR Measure
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30160), 
beginning with the 2018 performance period and for future program 
years, we proposed that QCDR vendors may seek permission from another 
QCDR to use an existing measure that is owned by the other QCDR. If a 
QCDR would like report on an existing QCDR measure that is owned by 
another QCDR, they must have permission from the QCDR that owns the 
measure that they can use the measure for the performance period. 
Permission must be granted at the time of self-nomination, so that the 
QCDR that is using the measure can include the proof of permission for 
CMS review and approval for the measure to be used in the performance 
period. The QCDR measure owner (QCDR vendor) would still own and 
maintain the QCDR measure, but would allow other approved QCDRs to 
utilize their QCDR measure with proper notification. We noted that the 
proposal would help to harmonize clinically similar measures and limit 
the use of measures that only slightly differ from another. We invited 
comments on this proposal.
(c) Full Development and Testing of QCDR Measures by Self-Nomination
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30160), 
we sought comment for future rulemaking, on requiring QCDRs that 
develop and report on QCDR measures, to fully develop and test (that 
is, conduct reliability and validity testing) their QCDR measures, by 
the time of submission of the new measure during the self-nomination 
process. We received a number of comments on this item and appreciate 
the input received. As this was a request for comment only, we will 
take the feedback provided into consideration for possible inclusion in 
future rulemaking.
    The following is a summary of the public comments received on the 
``QCDR Measure Specifications Criteria'' proposals and our responses:
    Comment: Several commenters supported the proposal to allow QCDRs 
to seek permission to use another vendor's QCDR's measures for reasons 
including that developing and testing measures is a costly process; the 
measure steward has the resources and clinical guidance to ensure 
appropriate use for consistency that will assist with reporting; it is 
intended to harmonize measures; it could allow similar types of 
clinicians to report the same measure regardless of their TIN 
structure; allowing the same measures to be collected by the QCDR 
registries for different specialties at the same time would give CMS 
and the physician community a more complete picture regarding the 
quality of care being

[[Page 53814]]

provided to Medicare beneficiaries; and it will reduce the 
proliferation of similar measures that may be duplicative. One 
commenter also sought clarity as to the mechanism the Agency will use 
to identify ``shared'' measures and recommended that CMS do the 
following to increase clarity, harmonization, and transparency 
including: (1) Require that if the specifications are not identical to 
the original QCDR's measure(s), the borrowing QCDR must identify, 
provide a rationale, and make public any changes made to the measure 
specifications; (2) require the original measure steward/owner be 
identified in the borrowing QCDR's list of measures; and (3) establish 
some system of identification (that is, tags or numbers similar to MIPS 
measures) so it is clear when one measure is used in multiple QCDRs.
    Response: We thank the commenters for their recommendations. 
Similar to how we identify the stewards of MIPS quality measures, we 
agree that it is important to identify when QCDR measures are owned by 
another QCDR. In response, we are modifying our proposal, such that as 
a part of the self-nomination review process for the 2018 performance 
period and future years, we will assign QCDR measure IDs once the QCDR 
measure has been approved, and the same measure ID must be used by any 
other QCDRs that have received permission to also report the measure. 
If a QCDR measure has been assigned a measure ID from a previous 
performance period, the secondary QCDR must use the previously assigned 
measure ID and identify the QCDR that the measure belongs to as a part 
of their self-nomination application. As stated in our proposal above, 
permission must be granted at the time of self-nomination, so that the 
borrowing QCDR using the measure can include proof of permission in 
their application. Additionally, as finalized in section 
II.C.10.b.(2)(b)(iii) of this final rule with comment period, we will 
only accept self-nomination applications through the Web-based tool and 
will provide additional guidance as to what information needs to be 
submitted for QCDR measure specifications through the 2018 Self-
Nomination User Guide that will be posted on our Web site. To be clear, 
if a QCDR is requesting permission to use another QCDR's measure, the 
borrowing QCDR must use the exact measure specification as provided by 
the QCDR measure owner. We expect that if a QCDR measure owner 
implements a change to their QCDR measure, and the change is approved 
by us during the QCDR measure review process (as outlined previously in 
this final rule with comment period), secondary QCDRs borrowing the 
QCDR measure must use the updated specifications.
    Comment: One commenter requested that CMS clarify what form proof 
of permission must take to satisfy the requirements of the self-
nomination application process. Another commenter recommended that CMS 
reconsider the proposal to require that a QCDR must, by the time of 
self-nomination, have permission from the QCDR that owns the measure 
that they can use the measure for the performance period and rather 
provide the ability to add reportable measures throughout the year.
    Response: As a clarification to the proposal, for the 2018 self-
nomination period and for future performance periods, the self-
nomination form that is available through the Web-based tool, will 
include two additional fields: One that questions whether the QCDR 
measure is owned by another QCDR, and another that questions the 
secondary QCDR to attest that it has received written permission to use 
another QCDR's measure. We leave these agreements and their details to 
QCDRs to determine. We may request that the secondary QCDR provide 
proof that permission was received in instances where we seek further 
verification. As stated in our proposal, permission must be established 
by the QCDR at the time of self-nomination.
    Final Action: After consideration of the public comments received, 
we are finalizing, with modification that beginning with the 2018 
performance period and for future program years, QCDRs can report on an 
existing QCDR measure that is owned by another QCDR. In response to 
comments, we are modifying our proposal to also include that we will 
assign QCDR measure IDs after the QCDR measure has been approved, and 
the same measure ID must be used by other QCDRs that have received 
permission to also report the measure. Furthermore, the self-nomination 
form that is available via the Web-based tool will be modified to 
include a field that will request QCDR measure IDs if the measure has 
been previously approved and assigned a MIPS QCDR measure ID.
    We are also clarifying and updating at Sec.  414.1400(f)(3) that 
the QCDR must publicly post the measure specifications no later than 15 
calendar days, not business days, following our approval of these 
measures specifications for each approved QCDR measure.
    For the 2018 performance period and future performance periods, we 
are finalizing the following proposal: That QCDRs may report on QCDR 
measures owned by another QCDR with the appropriate permissions; and we 
clarify that QCDRs must publicly post QCDR measure specifications no 
later than 15 calendar days following our approval of the measures 
specifications.
(6) Identifying QCDR Quality Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77375 
through 77377), we finalized the definition and types of QCDR quality 
measures for purposes of QCDRs submitting data for the MIPS quality 
performance category. In the CY 2018 Quality Payment Program proposed 
rule (82 FR 30160), we did not propose any changes to the criteria on 
how to identify QCDR quality measures. However, in the proposed rule, 
we clarified that QCDRs are not limited to reporting on QCDR measures, 
and may also report on MIPS measures as indicated in section 
II.C.10.b.(4) of this final rule with comment period, the QCDR data 
submission criteria section.
    As the MIPS program progresses in its implementation, we are 
interested in elevating the standards for which QCDR measures are 
selected and approved for use. We are interested in further aligning 
our QCDR measure criteria with that used under the Call for Quality 
Measures process, as is described in the CY 2017 Quality Payment 
Program final rule (81 FR 77151). We seek comment in this final rule 
with comment period, on whether the standards used for selecting and 
approving QCDR measures should align more closely with the standards 
used for the Call for Quality Measures process for consideration in 
future rule making.
(7) Collaboration of Entities To Become a QCDR
    In the CY 2017 Quality Payment Program final rule (81 FR 77377), we 
finalized policy on the collaboration of entities to become a QCDR. In 
the CY 2018 Quality Payment Program proposed rule (82 FR 30161), we did 
not propose any changes to this policy.
c. Health IT Vendors That Obtain Data From MIPS Eligible Clinicians' 
Certified EHR Technology (CEHRT)
    In the CY 2017 Quality Payment Program final rule (81 FR 77382), we 
finalized definitions and criteria around health IT vendors that obtain 
data from MIPS eligible clinicians CEHRT. We note that, a health IT 
vendor that serves as a third party intermediary to collect or submit 
data on behalf MIPS eligible clinicians may or may not also be a

[[Page 53815]]

``health IT developer.'' We refer readers to the CY 2018 Quality 
Payment Program proposed rule (82 FR 30161) for additional information 
regarding health IT vendors. Throughout this rule, we used the term 
``health IT vendor'' to refer to entities that support the health IT 
requirements of a clinician participating in the Quality Payment 
Program.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), 
we did not propose any changes to this policy in the proposed rule. 
However, we sought comment for future rulemaking regarding the 
potential shift to seeking alternatives which might fully replace the 
QRDA III format in the Quality Payment Program in future program years. 
We received a number of comments on this item and appreciate the input 
received. As this was a request for comment only, we will take the 
feedback provided into consideration for possible inclusion in future 
rulemaking.
d. Qualified Registries
    In the CY 2017 Quality Payment Program final rule (81 FR 77382 
through 77386), we finalized the definition and capability of qualified 
registries. As previously established, if an entity becomes qualified 
as a qualified registry, they will need to sign a statement confirming 
that this information is currect prior to listing it on our Web site 
(81 FR 77383). Once we post the qualified registry on our Web site, 
including the services offered by the qualified registry, we will 
require the qualified registry to support these services and measures 
for its clients as a condition of the entity's participation as a 
qualified registry in MIPS (81 FR 77383). Failure to do so will 
preclude the qualified registry from participation in MIPS in the 
subsequent year (81 FR 77383). In the CY 2018 Quality Payment Program 
proposed rule (82 FR 30161), we did not propose any changes to the 
definition or the capabilities of qualified registries. However, we did 
propose changes to the self-nomination process for the 2019 performance 
period. This is discussed in detail below.
(1) Establishment of an Entity Seeking To Qualify as a Registry
    In the CY 2017 Quality Payment Program final rule (81 FR 77383), we 
finalized the requirements for the establishment of an entity seeking 
to qualify as a registry. In the CY 2018 Quality Payment Program 
proposed rule (82 FR 30161), we did not propose any changes to the 
criteria regarding the establishment of an entity seeking to qualify as 
a registry criteria.
(2) Self-Nomination Process
(a) Generally
    In the CY 2017 Quality Payment Program final rule (81 FR 77383 
through 77384), we finalized procedures and requirements for qualified 
registries to self-nominate. Additional details regarding self-
nomination requirements for the self-nomination form can be found in 
the qualified registry fact sheet and the self-nomination user guide, 
that are posted in the resource library of the Quality Payment Program 
Web site at https://qpp.cms.gov/about/resource-library.
    For the 2018 performance period, and for future years of the 
program, we finalized in the CY 2017 Quality Payment Program final rule 
(81 FR 77383) and Sec.  414.1400(g) a self-nomination period for 
qualified registries from September 1 of the year prior to the 
applicable performance period, until November 1 of the same year. For 
example, for the 2018 performance period, the self-nomination period 
would begin on September 1, 2017, and end on November 01, 2017. 
Entities that desire to qualify as a qualified registry for purposes of 
MIPS for a given performance period will need to provide all requested 
information to us at the time of self-nomination and would need to 
self-nominate for that performance period (81 FR 77383). Having 
previously qualified as a qualified registry does not automatically 
qualify the entity to participate in subsequent MIPS performance 
periods (81 FR 77383). Furthermore, prior performance of the qualified 
registry (when applicable) will be taken into consideration in approval 
of their self-nomination. For example, a qualified registry may choose 
not to continue participation in the program in future years, or the 
qualified registry may be precluded from participation in a future 
year, due to multiple data or submission errors as noted in section 
II.C.10.f. of this final rule with comment period. As such, we believe 
an annual self-nomination process is the best process to ensure 
accurate information is conveyed to MIPS eligible clinicians and 
accurate data is submitted to MIPS. In this final rule with comment 
period, we are establishing a simplified process for existing qualified 
registries in good standing.
(b) Simplified Self-Nomination Process for Existing Qualified 
Registries in MIPS, That Are in Good Standing
    We do understand that some qualified registries may not have any 
changes to the measures and/or activity inventory they offer to their 
clients and intend to participate in MIPS for many years. In the CY 
2018 Quality Payment Program proposed rule (82 FR 30161), we proposed, 
beginning with the 2019 performance period, a simplified process, to 
reduce the burden of self-nomination for those existing qualified 
registries that have previously participated in MIPS and are in good 
standing (not on probation or disqualified, as described below), and to 
allow for sufficient time for us to review data submissions and make 
determinations. Our proposals to simplify the process for existing 
qualified registries in good standing with no changes, minimal changes, 
and those with substantive changes are discussed below.
(i) Existing Qualified Registries in Good Standing, With No Changes
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), 
we proposed, beginning with the 2019 performance period, a simplified 
process for which existing qualified registries in good standing may 
continue their participation in MIPS, by attesting that the qualified 
registry's previously approved: Data validation plan, cost to use the 
qualified registry, measures, activities, services, and performance 
categories used in the previous year's performance period of MIPS have 
no changes and will be used for the upcoming performance period. 
Specifically, existing qualified registries in good standing with no 
changes may attest during the self-nomination period, between September 
1 and November 1, that they have no changes to their approved self-
nomination application from the previous year from the previous year of 
MIPS. By attesting that all aspects of their approved application from 
the previous year have not changed, these existing qualified registries 
in good standing would be spending less time completing the entire 
self-nomination form, as was previously required on a yearly basis.
(ii) Existing Qualified Registries in Good Standing With Minimal 
Changes
    Beginning with the 2019 performance period, existing qualified 
registries in good standing that would like to make minimal changes to 
their previously approved self-nomination application from the previous 
year, may submit these changes, and attest to no other changes from 
their previously approved qualified registry application, for CMS 
review during the self-nomination period, from September 1 to November 
1. In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), 
we proposed that minimal changes

[[Page 53816]]

include: Limited changes to their supported performance categories, 
adding or removing MIPS quality measures, adding or updating existing 
services and/or the costs to use the registry.
(iii) Existing Qualified Registries in Good Standing With Substantive 
Changes
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), 
we inadvertently left out language in the preamble that explained our 
proposed updates to Sec.  414.1400(g), which were included in the 
proposed amendments to 42 CFR chapter IV at 82 FR 30255, and stated 
that:
    For the 2018 performance period and future years of the program, 
the qualified registry must self-nominate from September 1 of the prior 
year until November 1 of the prior year. Entities that desire to 
qualify as a qualified registry for a given performance period must 
self-nominate and provide all information requested by CMS at the time 
of self-nomination. Having qualified as a qualified registry does not 
automatically qualify the entity to participate in subsequent MIPS 
performance periods. Beginning with the 2019 performance period, 
existing qualified registries that are in good standing may attest that 
certain aspects of their previous year's approved self-nomination have 
not changed and will be used for the upcoming performance period. CMS 
may allow existing qualified registries in good standing to submit 
minimal or substantive changes to their previously approved self-
nomination form from the previous year, during the annual self-
nomination period, for CMS review and approval without having to 
complete the entire qualified registry self-nomination application 
process.
    This language mirrors that proposed for QCDRs (82 FR 30255) and 
finalized above in section II.C.10.b. of this final rule with comment 
period. Our intention was to parallel the simplified self-nomination 
process available to QCDRs in good standing beginning with the 2019 
performance period, including for substantive changes, such that 
Qualified Registries could do the same. The update to Sec.  
414.1400(g), as included in the proposed rule, allows a qualified 
registry to also submit substantive changes, in addition to minor 
changes, through the simplified self-nomination process. Therefore, we 
are clarifying here in this final rule with comment period that 
beginning with the 2019 performance period, CMS may allow existing 
qualified registries in good standing to submit substantive changes, in 
addition to minimal changes as discussed in the section above, to their 
previously approved self-nomination form from the previous year, during 
the annual self-nomination period. We are also clarifying that 
substantive changes may include, but are not limited to: Updates to a 
qualified registry's data validation plan, or a change in the qualified 
registry's organization structure that would impact any aspect of the 
qualified registry. We are also clarifying that the information 
required to be submitted for any changes would be the same as that 
required under the normal self-nomination process as previously 
finalized. We refer readers to the CY 2017 Quality Payment Program 
final rule (81 FR 77383 through 77384), where we finalized the 
information a qualified registry must provide to us at the time of 
self-nomination as well as (82 FR 30162) and Sec.  414.1400(g).
(c) Multi-Year Approval of Qualified Registries
    In the development of the above proposal, we had also reviewed the 
possibility of offering a multi-year approval, in which qualified 
registries would be approved for a 2-year increment of time. However, 
we are concerned that utilizing a multi-year approval process would 
restrict qualified registries by having them support the same fixed 
services they had for the first year, and would not provide qualified 
registries with the flexibility to add or remove services, measures, 
and/or activities based on their qualified registry's capabilities for 
the upcoming year. Furthermore, under a multi-year approval process, 
qualified registries would not be able to make changes to their 
organizational structure (as noted above) and would also create 
complications in our process for placing qualified registries who 
perform poorly (during the first year) on probation or disqualifying 
them (as described below). Moreover, a multi-year approval process 
would not take into consideration potential changes in criteria or 
requirements of participation for qualified registries, that may occur 
as the MIPS program develops through future program years. For the 
reasons stated above, we believe an annual self-nomination period is 
appropriate. We understand that stakeholders are interested in a multi-
year approval process, for that reason we intend to revisit the topic 
once we have gained additional experience with the self-nomination 
process under MIPS. We seek comment from stakeholders as to how they 
believe our aforementioned concerns with multi-year approvals of 
qualified registries can be resolved.
(d) Web-Based Submission of Self-Nomination Forms
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30162), 
for the 2018 performance period and beyond, we proposed that self-
nomination information must be submitted via a Web-based tool, and to 
eliminate the submission method of email. We noted that we will provide 
further information about the web-based tool at www.qpp.cms.gov.
    We invited public comment on: (1) Our proposals regarding a 
simplified self-nomination process beginning with the 2019 performance 
period for previously approved qualified registries in good standing; 
(2) multi-year approvals; and (3) our proposal to submit self-
nomination information via a web-based tool. The following is a summary 
of the public comments received on the ``Self-Nomination Period'' 
proposals and our responses:
    Comment: A few commenters supported the proposal to allow a 
simplified self-nomination process for qualified registries in good 
standing for reasons including a belief it would be more efficient.
    Response: We thank the commenters for their support.
    Comment: A few commenters supported the proposal that beginning 
with the 2018 performance period self-nomination information for a 
qualified registry must be submitted via a Web-based tool, rather than 
email, because they believed it will simplify the process.
    Response: We thank the commenters for their support.
    Comment: One commenter requested clarification on the proposal for 
simplification of the self-nomination process for qualified registries, 
specifically to confirm: (1) For 2018, the only proposed change from 
2017 is that the self-nomination submission process will be via a web-
based tool rather than email; and (2) it is not until 2019 that the 
self-nomination submission process will be replaced with the 
attestation for existing qualified registries.
    Response: For the 2018 performance period, the only change proposed 
is that self-nomination submission will occur via a web-based tool 
rather than email. The simplified self-nomination process would be 
available for qualified registries in good standing beginning with the 
2019 performance period. In addition, in order to align with the QCDR 
process finalized above, we are providing clarification here. We 
recognize that the existing process and our proposals could use 
additional clarification. The qualified registry self-

[[Page 53817]]

nomination form requires: contact information, services, costs 
associated with using the qualified registry, performance categories 
supported, MIPS quality measures, and data validation plan to be 
considered for the next performance period (81 FR 77383 through 77384). 
Details regarding self-nomination requirements can be found in the 
qualified registry fact sheet and the self-nomination user guide, that 
are posted in the resource library of the Quality Payment Program Web 
site at https://qpp.cms.gov/about/resource-library.
    Under our proposals, we are clarifying that beginning with the 2019 
performance period, any previously approved qualified registry in good 
standing (meaning, those that are not on probation or disqualified) 
that wishes to self nominate using the simplified process can attest, 
in whole or in part, that their previously approved form is still 
accurate and applicable. Specifically, under this process, qualified 
registries with no changes can attest that their previously submitted 
qualified registry self-nomination form in its entirety remains the 
same. Similarly, previously approved qualified registries in good 
standing that wish to self nominate using the simplified process and 
have minimal changes can attest to aspects of their previously 
submitted form that remain the same, but would additionally be required 
to outline any minimal changes for our review and approval through the 
self-nomination review process. Additional instructions regarding the 
completion of this simplified self-nomination form will be available on 
our Web site prior to the start of the self-nomination process for the 
2019 performance period. As stated in our proposal above, minimal 
changes include, but are not limited to: Limited changes to performance 
categories, adding or removing MIPS quality measures, and adding or 
updating existing services and/or cost information.
    Furthermore, we are also clarifying that any previously approved 
qualified registry in good standing that wishes to self nominate using 
the simplified process can submit substantive changes while attesting 
that the remainder of their application remains the same from the 
previous year. Substantive changes include, but are not limited to: 
Updates to the qualified registry's data validation plan, or a change 
in the qualified registry's organization structure that would impact 
any aspect of the qualified registry. For example, if a previously 
approved qualified registry in good standing would like to submit 
changes only to it's MIPS quality measures, the qualified registry can 
attest that there are no changes to their self-nomination form, and 
provide updated MIPS quality measures information for CMS review and 
approval. We are also clarifying that the information required to be 
submitted for any changes would be the same as that required under the 
normal self-nomination process. We refer readers to the CY 2017 Quality 
Payment Program final rule (81 FR 77383 through 77384), where we 
finalized the information a qualified registry must provide to us at 
the time of self-nomination as well as (82 FR 30162) and Sec.  
414.1400(g).
    Comment: One commenter supported the simplified self-nomination 
process available for QCDRs and qualified registries. Specifically that 
existing QCDRs and qualified registries in good standing may also make 
substantive or minimal changes to their approved self-nomination 
application from the previous year of MIPS that would be submitted 
during the self-nomination period for CMS review and approval.
    Response: We thank the commenter for their support. As clarified 
above, in the CY 2018 Quality Payment Program proposed rule, we 
inadvertently left out language in the preamble that explained our 
proposed updates to Sec.  414.1400(g), which were included in the 
proposed rule at 82 FR 30255. The update to Sec.  414.1400(g) would 
allow a qualified registry to also submit substantive changes, in 
addition to minor changes, through the simplified self-nomination 
process. We refer readers to our clarification for existing Qualified 
Registries in good standing with substantive changes as discussed 
above.
    Comment: One commenter recommended that CMS allow qualified 
registries to report existing QCDR measures, using the same approval 
process that QCDRs would use.
    Response: Currently, qualified registries are limited to reporting 
MIPS quality measures that currently exist in the program, as described 
in the CY 2017 Quality Payment Program final rule (81 FR 77384). Should 
an entity wish to report on existing, approved QCDR measures they 
should consider self-nominating as a QCDR. However, we will take the 
commenter's feedback into consideration as we develop future policies.
    Final Action: After consideration of the public comments received, 
we are finalizing our proposals with clarifications. Specifically at 
Sec.  414.1400 (5)(g), we are finalizing our proposal, beginning with 
the 2019 performance period, that previously approved qualified 
registries in good standing (that are not on probation or disqualified) 
that wish to self nominate using the simplified process can attest, in 
whole or in part, that their previously approved form is still accurate 
and applicable. We are clarifying our proposals by elaborating on what 
would be required for previously approved qualified registries in good 
standing that wish to self-nominate and have changes. For abundant 
clarity, we are restating our finalized proposals with clarifications 
here:
    Beginning with the 2019 performance period, any previously approved 
qualified registry in good standing (meaning, those that are not on 
probation or disqualified) that wishes to self nominate using the 
simplified process can attest, in whole or in part, that their 
previously approved form is still accurate and applicable. 
Specifically, under this process, qualified registries with no changes 
can attest that their previously submitted qualified registry self-
nomination form in its entirety remains the same. Similarly, previously 
approved qualified registries in good standing that wish to self 
nominate using the simplified process and have minimal changes can 
attest to aspects of their previously submitted form that remain the 
same, but would additionally be required to update and describe any 
minimal changes in their self-nomination application for our review and 
approval. Minimal changes include, but are not limited to: limited 
changes to performance categories, adding or removing MIPS quality 
measures, and adding or updating existing services and/or cost 
information.
    We are also clarifying that any previously approved qualified 
registry in good standing that wishes to self nominate using the 
simplified process and has substantive changes may submit those 
substantive changes while attesting that the remainder of their 
application remains the same from the previous year. Substantive 
changes include, but are not limited to: Changes in the qualified 
registry's data validation plan, or changes in the qualified registry's 
organizational change in the qualified registry's organization 
structure that would impact any aspect of the qualified registry. We 
are clarifying that the information required to be submitted for any 
changes would be the same as that required under the normal self-
nomination process as previously finalized. Therefore, we are 
finalizing at Sec.  414.1400(g) the following: for the 2018 performance 
period and future years of the program, the qualified registry must 
self-nominate from September 1 of the prior year until

[[Page 53818]]

November 1 of the prior year. Entities that desire to qualify as a 
qualified registry for a given performance period must self-nominate 
and provide all information requested by us at the time of self-
nomination. Having qualified as a qualified registry does not 
automatically qualify the entity to participate in subsequent MIPS 
performance periods. Beginning with the 2019 performance period, 
existing qualified registries that are in good standing may attest that 
certain aspects of their previous year's approved self-nomination have 
not changed and will be used for the upcoming performance period. We 
may allow existing qualified registries in good standing to submit 
minimal or substantive changes to their previously approved self-
nomination form from the previous year, during the annual self-
nomination period, for our review and approval without having to 
complete the entire qualified registry self-nomination application 
process.
    We are also finalizing, as proposed, that for the 2018 performance 
period and beyond: (1) Self-nomination information must be submitted 
via a web-based tool, and (2) we are eliminating the submission method 
of email. We will provide further information on the web-based tool at 
www.qpp.cms.gov.
(3) Information Required at the Time of Self-Nomination
    We finalized in the CY 2017 Quality Payment Program final rule (81 
FR 77384) that a qualified registry must provide specific information 
to us at the time of self-nomination. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30162), we did not propose any changes to 
this policy.
(4) Qualified Registry Criteria for Data Submission
    In the CY 2017 Quality Payment Program final rule (81 FR 77386), we 
finalized the criteria for qualified registry data submission. In the 
CY 2018 Quality Payment Program proposed rule (82 FR 30162), we did not 
propose any changes to this policy. Although no changes were proposed, 
however we made two clarifications to the existing criteria:
     In the CY 2017 Quality Payment Program final rule (81 FR 
77385), we specify that qualified registries must enter into and 
maintain with its participating MIPS eligible clinicians an appropriate 
MIPS eligible clinicians an appropriate Business Associate agreement. 
The Business Associate agreement should provide for the qualified 
registry's receipt of patient-specific data from an individual MIPS 
eligible clinician or group; as well as the qualified registry's 
disclosure of quality measure results and numerator and denominator 
data or patient specific data on Medicare and non-Medicare 
beneficiaries on behalf of individual MIPS eligible clinicians and 
groups. As stated in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30162), we are clarifying that the Business Associate agreement 
must comply with the HIPAA Privacy and Security Rules.
     We had finalized in the CY 2017 Quality Payment Program 
final rule (81 FR 77384) that timely feedback be provided at least four 
times a year, on all of the MIPS performance catgeories that the 
qualified registry will report to us. We are clarifying that readers 
should refer to section II.C.9.a. of this rule for additional 
information on third party intermediaries and performance feedback.
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77370) for additional information on allowing qualified 
registries ability to request CMS approval to support additional MIPS 
quality measures.
e. CMS-Approved Survey Vendors
    In the CY 2017 Quality Payment Program final rule (81 FR 77386), we 
finalized the definition, criteria, required forms, and vendor business 
requirements needed to participate in MIPS as a survey vendor. In the 
CY 2018 QPP proposed rule (82 FR 30162), we did not propose changes to 
those policies. However, in the CY 2016 PFS rule (80 FR 71143) we heard 
from some groups that it would be useful to have a final list of CMS-
approved survey vendors to inform their decision on whether or not to 
participate in the CAHPS for MIPS survey. Therefore, in the proposed 
rule, we proposed to change the survey vendor application deadline in 
order to timely display a final list of CMS-approved survey vendors. 
This is discussed in more detail below.
(1) Updated Survey Vendor Application Deadline
    In the CY 2017 Quality Payment Program final rule (81 FR 77386), we 
finalized a survey vendor application deadline of April 30th of the 
performance period. We also finalized that survey vendors would be 
required to undergo training, to meet our standards on how to 
administer the survey, and submit a quality assurance plan (81 FR 
77386). In the CY 2018 Quality Payment Program proposed rule (82 FR 
30162-30163), we noted that the current CAHPS for MIPS survey timeframe 
from the 2017 performance period conflicts with the timeframe in which 
groups can elect to participate in the CAHPS for MIPS survey. We would 
like to clarify that the current CAHPS for MIPS survey vendor 
application deadline from the 2017 performance period of April 30th 
conflicts with the timeframe in which groups can elect to participate 
in the CAHPS for MIPS survey, of April 1st to June 30th. In order to 
provide a final list of CMS-approved survey vendors earlier in the 
timeframe during which groups can elect to participate in the CAHPS for 
MIPS survey, an earlier vendor application deadline would be necessary. 
This could be accomplished by having a rolling application period, 
where vendors would be able to submit an application by the end of the 
first quarter. The rolling application period that would end by the 
first quarter would allow us to adjust the application deadline beyond 
January 31st on a year to year basis, based on program needs. However, 
in addition to submitting a vendor application, vendors must also 
complete vendor training and submit a Quality Assurance Plan and we 
need to allow sufficient time for these requirements as well.
    Therefore, in the CY 2018 Quality Payment Program proposed rule (82 
FR 30162 through 30163), we proposed for the 2018 performance period of 
the Quality Payment Program and future years that the vendor 
application deadline would be January 31st of the applicable 
performance year or a later date specified by CMS. The proposal would 
allow us to adjust the application deadline beyond January 31st on a 
year to year basis, based on program needs. We would notify vendors of 
the application deadline to become a CMS-approved survey vendor through 
additional communications and postings on the Quality Payment Program 
Web site, qpp.cms.gov. We requested comments on this proposal and other 
alternatives that would allow us to provide a final list of CMS-
approved survey vendors early in the timeframe during which groups can 
elect to participate in the CAHPS for MIPS survey.
    We did not receive any comments related to this proposal.
    Final Action: We are finalizing our policy, as proposed, therefore 
beginning with the 2018 performance period and for future years, the 
vendor application deadline will be January 31st of the applicable 
performance year or a later date specified by CMS as discussed in this 
final rule with comment period. Therefore, we are finalizing at Sec.  
414.1400(i), the following: Vendors are required to undergo the CMS 
approval

[[Page 53819]]

process for each year in which the survey vendor seeks to transmit 
survey measures data to CMS. Applicants must adhere to any deadlines 
specified by CMS.
f. Probation and Disqualification of a Third Party Intermediary
    At Sec.  414.1400(k), we finalized the process for placing third 
party intermediaries on probation and for disqualifying such entities 
for failure to meet certain standards established by us (81 FR 77386). 
Specifically, we proposed that if at any time we determine that a third 
party intermediary (that is, a QCDR, health IT vendor, qualified 
registry, or CMS-approved survey vendor) has not met all of the 
applicable criteria for qualification, we may place the third party 
intermediary on probation for the current performance period or the 
following performance period, as applicable (81 FR 77389). We refer 
readers to the CY 2018 Quality Payment Program proposed rule (81 FR 
30163) for additional information regarding the probation and 
disqualification process.
    In the CY 2017 Quality Payment Program final rule with comment (81 
FR 77388), we stated that MIPS eligible clinicians are ultimately 
responsible for the data that are submitted by their third party 
intermediaries and expect that MIPS eligible clinicians and groups 
should ultimately hold their third party intermediaries accountable for 
accurate reporting. We also stated that we would consider from the MIPS 
eligible clinicians and groups perspective, cases of vendors leaving 
the marketplace (81 FR 77388) during the performance period on a case 
by case basis, but that we will not consider cases prior to the 
performance period. Furthermore, we stated that we would need proof 
that the MIPS eligible clinician had an agreement in place with the 
vendor at the time of their withdrawal from the marketplace.
    While we did not propose any changes to the process of probation 
and disqualification of a third party intermediary in the CY 2018 
Quality Payment Program proposed rule (82 FR 30163), we received a 
number of comments on this item and appreciate the input received.
g. Auditing of Third Party Intermediaries Submitting MIPS Data
    In the CY 2017 Quality Payment Program final rule (81 FR 77389), we 
finalized at Sec.  414.1400(j) that any third party intermediary (that 
is, a QCDR, health IT vendor, qualified registry, or CMS-approved 
survey vendor) must comply with the following procedures as a condition 
of their qualification and approval to participate in MIPS as a third 
party intermediary:
    (1) The entity must make available to us the contact information of 
each MIPS eligible clinician or group on behalf of whom it submits 
data. The contact information will include, at a minimum, the MIPS 
eligible clinician or group's practice phone number, address, and if 
available, email;
    (2) The entity must retain all data submitted to us for MIPS for a 
minimum of 10 years; and
    (3) For the purposes of auditing, we may request any records or 
data retained for the purposes of MIPS for up to 6 years and 3 months.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30163), 
we proposed to update Sec.  414.1400(j)(2) from stating that the entity 
must retain all data submitted to us for MIPS for a minimum of 10 years 
to state that the entity must retain all data submitted to us for 
purposes of MIPS for a minimum of 10 years from the end of the MIPS 
performance period.
    We invited public comment on our proposal, but did not receive any.
    Final Action: We are finalizing our proposal with modification. We 
are modifying the record retention provision at Sec.  414.1400(j)(2) to 
align with the record retention provisions elsewhere in this final rule 
with comment period. We refer readers to section II.C.9.c. of this 
final rule with comment period where we discuss and respond to public 
comments we received on our proposal to add a new paragraph (d) at 
Sec.  414.1390, codifying our record retention policy for MIPS eligible 
clinicians and groups. Based on comments we received on the 10 year 
record retention period at Sec.  414.1390(d) regarding time and 
financial burden in managing, storing, and retrieving data and 
information, and our interest in reducing financial and time burdens 
under this program and having consistent policies across this program, 
we are modifying our proposed 10-year retention requirement at Sec.  
414.1400(j)(2) to a 6-year retention requirement.
    Similarly, we finalized in the CY 2017 Quality Payment Program 
final rule (81 FR 77389-77390) at Sec.  414.1400(j)(3) that for the 
purposes of auditing, we may request any records or data retained for 
the purposes of MIPS for up to 6 years and 3 months. While we did not 
propose any changes or updates to this policy in the CY 2018 QPP 
proposed rule, based on our modifications to Sec.  414.1390(d) and 
Sec.  414.1400(j)(2), as discussed previously in this final rule with 
comment period, we are also updating Sec.  414.1400(j)(3) to reflect 
these same changes and allow us to request any records or data retained 
for the purposes of MIPS for up to 6 years from the end of the MIPS 
performance period. We believe this change will promote consistent and 
cohesive policies across this program.
11. Public Reporting on Physician Compare
    This section contains the approach for public reporting on 
Physician Compare for year 2 of the Quality Payment Program (2018 data 
available for public reporting in late 2019) and future years, 
including MIPS, APMs, and other information as required by the MACRA 
and building on the MACRA public reporting policies previously 
finalized (81 FR 77390 through 77399).
    Physician Compare draws its operating authority from section 
10331(a)(1) of the Affordable Care Act. As required by section 
10331(a)(1) of the Affordable Care Act, by January 1, 2011, we 
developed a Physician Compare Internet Web site with information on 
physicians enrolled in the Medicare program under section 1866(j) of 
the Act, as well as information on other EPs who participate in the 
PQRS under section 1848 of the Act. More information about Physician 
Compare can be accessed on the Physician Compare Initiative Web site at 
https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/.
    The first phase of Physician Compare was launched on December 30, 
2010 (http://www.medicare.gov/physiciancompare). Since the initial 
launch, Physician Compare has been continually improved, and more 
information has been added. In December 2016, the site underwent a 
complete user-informed, evidenced-based redesign to further enhance 
usability and functionality on both desktop computers and mobile 
devices and to begin to prepare the site for the inclusion of more data 
as required by the MACRA.
    Consistent with section 10331(a)(2) of the Affordable Care Act, 
Physician Compare initiated a phased approach to public reporting 
performance scores that provide comparable information on quality and 
patient experience measures for reporting periods beginning January 1, 
2012. The first set of quality measures were publicly reported on 
Physician Compare in February 2014. A complete history of public 
reporting on Physician Compare is detailed in the CY 2016 PFS final 
rule (80 FR 71117 through 71122). The Physician Compare Initiative Web 
site at https://www.cms.gov/medicare/

[[Page 53820]]

quality-initiatives-patient-assessment-instruments/physician-compare-
initiative/ is regularly updated to provide information about what is 
currently available on the Web site.
    As finalized in the CY 2015 and CY 2016 PFS final rules (79 FR 
67547 and 80 FR 70885, respectively), Physician Compare will continue 
to expand public reporting. This expansion includes publicly reporting 
both individual eligible professional (now referred to as eligible 
clinician) and group-level QCDR measures starting with 2016 data 
available for public reporting in late 2017, as well as the inclusion 
of a 5-star rating based on a benchmark in late 2017 based on 2016 data 
(80 FR 71125 and 71129), among other additions.
    This expansion will continue under the MACRA. Sections 
1848(q)(9)(A) and (D) of the Act facilitate the continuation of our 
phased approach to public reporting by requiring the Secretary to make 
available on the Physician Compare Web site, in an easily 
understandable format, individual MIPS eligible clinician and group 
performance information, including:
     The MIPS eligible clinician's final score;
     The MIPS eligible clinician's performance under each MIPS 
performance category (quality, cost, improvement activities, and 
advancing care information);
     Names of eligible clinicians in Advanced APMs and, to the 
extent feasible, the names of such Advanced APMs and the performance of 
such models; and,
     Aggregate information on the MIPS, posted periodically, 
including the range of final scores for all MIPS eligible clinicians 
and the range of the performance of all MIPS eligible clinicians for 
each performance category.
    Initial plans to publicly report this performance information on 
Physician Compare were finalized in the CY 2017 Quality Payment Program 
final rule (81 FR 77390). The proposals related to each of these 
requirements for year 2 of the Quality Payment Program are summarized 
below in this section.
    Section 1848(q)(9)(B) of the Act also requires that this 
information indicate, where appropriate, that publicized information 
may not be representative of the eligible clinician's entire patient 
population, the variety of services furnished by the eligible 
clinician, or the health conditions of individuals treated. The 
information mandated for Physician Compare under section 1848(q)(9) of 
the Act will generally be publicly reported consistent with sections 
10331(a)(2) and 10331(b) of the Affordable Care Act, and like all 
measure data included on Physician Compare, will be comparable. In 
addition, section 10331(b) of the Affordable Care Act requires that we 
include, to the extent practicable, processes to ensure that data made 
public are statistically valid, reliable, and accurate, including risk 
adjustment mechanisms used by the Secretary. In addition to the public 
reporting standards identified in the Affordable Care Act, we have 
established a policy that, as determined through user testing, the data 
we disclose generally should resonate with and be accurately 
interpreted by Web site users to be included on Physician Compare 
profile pages. Together, we refer to these conditions as the Physician 
Compare public reporting standards (80 FR 71118 through 71120). Section 
10331(d) of the Affordable Care Act also requires us to consider input 
from multi-stakeholder groups, consistent with sections 1890(b)(7) and 
1890A of the Act. We continue to receive general input from 
stakeholders on Physician Compare through a variety of means, including 
rulemaking and different forms of stakeholder outreach (for example, 
Town Hall meetings, Open Door Forums, webinars, education and outreach, 
the Technical Expert Panel convened by our Physician Compare support 
team contractor, etc.).
    In addition, section 1848(q)(9)(C) of the Act requires the 
Secretary to provide an opportunity for eligible clinicians to review 
the information that will be publicly reported prior to such 
information being made public. This is generally consistent with 
section 10331(a)(2) of the Affordable Care Act, under which we have 
established a 30-day preview period for all measurement performance 
data that allows physicians and other eligible clinicians to view their 
data as it will appear on the Web site in advance of publication on 
Physician Compare (80 FR 77392). Section 1848(q)(9)(C) of the Act also 
requires that eligible clinicians be able to submit corrections for the 
information to be made public with respect to the eligible clinician. 
We finalized a policy to continue the current Physician Compare 30-day 
preview period for MIPS eligible clinicians starting with data from the 
2017 MIPS performance period, which will be available for public 
reporting in late 2018. Therefore, we finalized a 30-day preview period 
in advance of the publication of data on Physician Compare (81 FR 
77392).
    We will coordinate data review and any relevant data resubmission 
or correction between Physician Compare and the four performance 
categories of MIPS. All data available for public reporting--measure 
rates, scores, and attestations, etc.--are available for review and 
correction during the targeted review process, which will begin at 
least 30 days in advance of the publication of new data. Data under 
review is not publicly reported until the review is complete. All 
corrected measure rates, scores, and attestations submitted as part of 
this process are available for public reporting. The technical details 
of the process are communicated directly to affected eligible 
clinicians and groups and detailed outside of rulemaking with specifics 
made public on the Physician Compare Initiative page on www.cms.gov and 
communicated through Physician Compare and other CMS listservs (81 FR 
77391).
    In addition, section 1848(q)(9)(D) of the Act requires that 
aggregate information on the MIPS be periodically posted on the 
Physician Compare Web site, including the range of final scores for all 
MIPS eligible clinicians and the range of performance for all MIPS 
eligible clinicians for each performance category.
    Lastly, section 104(e) of the MACRA requires the Secretary to make 
publicly available, on an annual basis, in an easily understandable 
format, information for physicians and, as appropriate, other eligible 
clinicians related to items and services furnished to people with 
Medicare, and to include, at a minimum:
     Information on the number of services furnished by the 
physician or other eligible clinician under Part B, which may include 
information on the most frequent services furnished or groupings of 
services;
     Information on submitted charges and payments for Part B 
services; and,
     A unique identifier for the physician or other eligible 
clinician that is available to the public, such as an NPI.
    The information is further required to be made searchable by at 
least specialty or type of physician or other eligible clinician; 
characteristics of the services furnished (such as volume or groupings 
of services); and the location of the physician or other eligible 
clinician.
    In accordance with section 104(e) of the MACRA, we finalized a 
policy in the CY 2016 PFS final rule (80 FR 71130) to add utilization 
data to the Physician Compare downloadable database. Utilization data 
is currently available at http://www.cms.gov/Research-Statistics-Data-
and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-
Data/Physician-and-Other-

[[Page 53821]]

Supplier.html. This information is integrated on the Physician Compare 
Web site via the downloadable database each year using the most current 
data, starting with the 2016 data, targeted for initial release in late 
2017 (80 FR 71130). Not all available data will be included. The 
specific HCPCS codes included are to be determined based on analysis of 
the available data, focusing on the most used codes. Additional details 
about the specific HCPCS codes that are included in the downloadable 
database will be provided to the public in advance of data publication. 
All data available for public reporting--on the public-facing Web site 
pages or in the downloadable database--are available for review during 
the 30-day preview period.
    We proposed to revise the public reporting regulation at Sec.  
414.1395(a) to more completely and accurately reference the data 
available for public reporting on Physician Compare and to remove from 
the heading and text references to ``MIPS'' and ``public Web site'' and 
instead reference ``Quality Payment Program'' and ``Physician 
Compare''. Specifically, we proposed to modify Sec.  414.1395(a) to 
read as follows: ``Public reporting of eligible clinician and group 
Quality Payment Program information. For each program year, CMS posts 
on Physician Compare, in an easily understandable format, information 
regarding the performance of eligible clinicians or groups under the 
Quality Payment Program.'' We also proposed to add paragraphs (b), (c), 
and (d) at Sec.  414.1395, to capture previously established policies 
for Physician Compare relating to the public reporting standards, first 
year measures, and the 30-day preview period. Specifically, at Sec.  
414.1395(b), we proposed that, with the exception of data that must be 
mandatorily reported on Physician Compare, for each program year, we 
rely on the established public reporting standards to guide the 
information available for inclusion on Physician Compare. The public 
reporting standards require data included on Physician Compare to be 
statistically valid, reliable, and accurate; be comparable across 
submission mechanisms; and, meet the reliability threshold. And, to be 
included on the public facing profile pages, the data must also 
resonate with Web site users, as determined by CMS. At Sec.  
414.1395(c), we proposed to codify our policy regarding first year 
measures to state that for each program year, CMS does not publicly 
report any first year measure, meaning any measure in its first year of 
use in the quality and cost performance categories. After the first 
year, CMS reevaluates measures to determine when and if they are 
suitable for public reporting. At Sec.  414.1395(d), we proposed to 
specify the 30-day preview period to state that for each program year, 
CMS provides a 30-day preview period for any clinician or group with 
Quality Payment Program data before the data are publicly reported on 
Physician Compare.
    The following is a summary of the public comments received on the 
proposed changes and additions to the regulation text at Sec.  
414.1395(a) through Sec.  414.1395(d) and our responses:
    Comment: No specific comments were received regarding our proposal 
at Sec.  414.1395(a) of the regulation text. Multiple commenters 
supported our proposal at Sec.  414.1395(b) to only include information 
on Physician Compare that meets our established public reporting 
standards. One commenter questioned how CMS would determine which 
measures meet these criteria. All commenters supported our proposal at 
Sec.  414.1395(c) not to publicly report first year quality and cost 
measures. Several commenters requested that CMS not report quality or 
cost measures for the first 3 years a measure is in use. Commenters 
specifically requested that CMS add data to Physician Compare 
gradually, specifically new data such as cost information. Finally, 
multiple commenters supported our proposal at Sec.  414.1395(d) to 
provide a30-day preview period for data prior to publication on 
Physician Compare. However, many commenters requested that the preview 
period be extended. Specifically, commenters requested an extension to 
45 days, 60 days, and 90 days. Commenters explained this would provide 
more time to review data, identify possible errors, and provide the 
needed documentation to CMS for consideration. Some commenters noted a 
longer preview period would be consistent with the Open Payments 
Program.
    Response: As indicated in the proposed rule (82 FR 30164), 
substantial statistical testing and user testing with patients and 
caregivers is conducted to determine which measures meet these 
criteria. Additional information about this testing and our findings 
will be shared on the Physician Compare Initiative page on www.cms.gov.
    Concerning the commenters support for not including first year 
quality and cost measures, we understand the request to further delay 
measures, but as we discuss in more detail later in this final rule 
with comment period, we do not find added value in waiting to provide 
the public with potentially valuable information after clinicians and 
groups have had a chance to review and understand the initial results 
and the measure is deemed to meet all public reporting criteria. We 
believe the benefit of releasing the data in a timely manner is 
significant, especially for the more established quality data. We will 
carefully evaluate the cost measure data after the first year, 
understanding this is new and complex information. With the exception 
of data that must be mandatorily reported on Physician Compare, if 
certain cost measure data is determined under our established public 
reporting standards not to be suitable for public reporting, it will 
not be reported. Also, as discussed in greater detail in this final 
rule with comment period, we will proceed with our phased approach to 
public reporting, addressing requests to move forward with public 
reporting gradually.
    Concerning the support for our 30-day preview period, we do 
understand the concerns raised about having ample time to review and 
contest data, if needed, but we do not believe a longer preview period 
is necessary. Historically, clinicians and groups have not initiated 
the preview process until near the end of the process, so we do not 
think that extending the preview period will provide additional value. 
We are actively working to ensure the preview process is more 
streamlined and user-friendly under the Quality Payment Program, which 
should also facilitate more easily obtaining the information needed to 
assist with previewing data. In addition, we are actively working to 
provide more information about the preview timeline and process each 
year through stakeholder outreach and the Physician Compare listserv. 
In light of these efforts, we believe the 30-day preview period is 
sufficient.
    Final Action: After consideration of the public comments, we are 
finalizing our proposed changes and additions to the regulation text at 
Sec.  414.1395(a) through Sec.  414.1395(d).
    We believe section 10331 of the Affordable Care Act supports the 
overarching goals of the MACRA by providing the public with quality 
information that will help them make informed decisions about their 
health care, while encouraging clinicians to improve the quality of 
care they provide to their patients. In accordance with section 10331 
of the Affordable Care Act, section 1848(q)(9) of the Act, and section 
104(e) of the MACRA, we plan to continue to publicly report performance 
information on Physician Compare. As such, we proposed the

[[Page 53822]]

inclusion of the following information on Physician Compare.
a. Final Score, Performance Categories, and Aggregate Information
    Sections 1848(q)(9)(A) and (D) of the Act require that we publicly 
report on Physician Compare the final score for each MIPS eligible 
clinician and the performance of each MIPS eligible clinician for each 
performance category, and that we periodically post aggregate 
information on the MIPS, including the range of final scores for all 
MIPS eligible clinicians and the range of performance of all the MIPS 
eligible clinicians for each performance category. We finalized such 
data for public reporting on Physician Compare for the transition year 
(81 FR 77393), and we proposed to add these data each year to Physician 
Compare for each MIPS eligible clinician or group, either on the 
profile pages or in the downloadable database, as technically feasible 
(82 FR 30165 through 30166). We will use statistical testing and user 
testing, as well as consultation with the Physician Compare Technical 
Expert Panel convened by the Physician Compare support team contractor, 
to determine how and where these data are best reported on Physician 
Compare. As the MACRA requires that this information be available for 
public reporting on Physician Compare, we proposed to include it each 
year moving forward, as technically feasible. We requested comment on 
this proposal to publicly report on Physician Compare the final score 
for each MIPS eligible clinician or group and the performance of each 
MIPS eligible clinician or group for each performance category, and to 
periodically post aggregate information on the MIPS, including the 
range of final scores for and the range of performance of all the MIPS 
eligible clinicians or groups for each performance category, as 
technically feasible.
    The following is a summary of the public comments received on the 
``Final Score, Performance Categories, and Aggregate Information'' 
proposals and our responses:
    Comment: Many commenters supported the inclusion of final score and 
other aggregate information on the Web site, appreciating that public 
reporting is statutorily-mandated. However, multiple commenters opposed 
reporting these data, citing concerns regarding whether the data 
reflect clinicians' true performance, as well as concerns regarding 
whether patients can appropriately use the data to make health care 
decisions. Alternatively, some commenters suggested that CMS wait to 
publish composite or aggregate information until further testing is 
completed, though some of these commenters supported the inclusion of 
as much information as possible in the downloadable database. 
Commenters noted concern that the ``Pick Your Pace'' option of 
participation in the early years of MIPS could make final score and 
aggregate information non-comparable and thus recommended against 
reporting it.
    Response: We appreciate both the support for this proposal and the 
concern raised regarding additional testing. Analysis and user testing 
of the final score and aggregate information, as with all data 
available for public reporting, will be ongoing, and we will actively 
work to share the results of this testing with stakeholders through 
outreach and via the Physician Compare Initiative page on cms.gov. User 
testing will also address the concern as to whether these data help 
patients and caregivers make health care decisions. We are taking steps 
to address concerns around the comparability of data and the ``Pick 
Your Pace'' options. With the exception of data that must be 
mandatorily reported on Physician Compare, all data considered for 
public reporting must meet our established public reporting standards. 
These include ensuring the data are comparable. Therefore, analyses 
will be done to ensure the chosen participation approach does not lead 
to non-comparable data on Physician Compare.
    Comment: Many commenters supported publicly reporting all MIPS 
measures, activities, and objectives across the four performance 
categories as proposed. One commenter specifically requested that CMS 
release all data, not subsets of data. If subsets are reported, the 
commenter requested that more information be made public about what was 
not released so it is clear what was and was not being provided to the 
public. Multiple commenters raised concerns about how missing data or a 
lack of data would be interpreted by Web site users. In general, 
commenters who supported our proposals to publicly report the MIPS data 
cited the importance of transparency and the benefit for patients and 
caregivers to have access to these data when making health care 
decisions.
    Response: We agree that reporting these data facilitates 
transparency and provides useful information to patients and 
caregivers. We also understand the desire to have full transparency, 
but as we begin the Quality Payment Program, we believe we should 
employ the same phased approach used at the start of public reporting 
under the legacy PQRS program to ensure the data made public most 
accurately represents clinical performance and is best understood by 
Web site users. Regarding concerns raised about the interpretation of 
missing data or a lack of data, this is a concept that has been tested 
with users under the legacy PQRS program. To date, we have found that 
users understand there are many reasons a clinician or group may not 
have data on the Web site, and they understand this is just the start 
of the public reporting process. We will actively work to ensure that 
the language on the Web site and the additional education and outreach 
conducted for patients and caregivers continues to make this message 
clear.
    Comment: Three commenters did not support publicly reporting 
individual measures, and noted that more testing of these measures was 
needed prior to public reporting. Another commenter supported including 
all data in the downloadable database, but not including the data on 
profile pages until more patient testing was done. This commenter also 
suggested that CMS obtain feedback on specific measures being 
considered for inclusion on profile pages. Another commenter cautioned 
that data included in the downloadable database could be misinterpreted 
by third-party users and used to mislead the public.
    Response: We have started the process of testing the data available 
under the Quality Payment Program with patients and caregivers. All 
data considered for inclusion on Physician Compare profile pages must 
be tested with patients and caregivers prior to being included on the 
Web site. We conduct extensive one-on-one testing to review all 
performance information under consideration for inclusion on the 
profile pages with both patients and caregivers around the country to 
ensure they understand the information, accurately interpret it, and 
find it useful in decision-making. Again, all data that are considered 
for public reporting on Physician Compare profile pages must meet our 
public reporting standards, and this includes that the data be 
accurately interpreted by patients and caregivers. We do understand 
concerns around the use of the downloadable database by third-party 
users and will take these into account when considering the data to be 
included. As noted, final decisions on which data are included will be 
determined based on statistical and user testing. In order for data to 
be reported in as timely a manner as possible, we will not provide the 
specific subset of measures targeted for public reporting for review 
and comment once testing is complete. All data are available for

[[Page 53823]]

preview for 30 days prior to publication, however.
    Comment: Several commenters supported our phased approach to public 
reporting MIPS data, but some commenters requested the information not 
be reported immediately. One commenter specifically suggested MIPS 
reporting be delayed until clinicians could review and improve on their 
data. Other commenters cautioned against reporting data in the 
transition years of the MIPS program when the program and information 
collected was new.
    Response: We understand the desire to delay reporting but note 
that, as discussed below in more detail, for the transition year (2017 
data available for public reporting in late 2018), no first year 
measures, activities, or objectives will be publicly reported on 
Physician Compare because we do appreciate that these are new data and 
would like clinicians and groups to have the opportunity to learn from 
the first year of reporting. However, as part of our phased approach, 
as we move into year 2 of the program (2018 data available for public 
reporting in late 2019), additional information will become available 
for public reporting in an effort to continue to advance the program, 
ensure increasing transparency and value to patients and caregivers, 
and help drive improvement.
    Comment: Some commenters requested that CMS make statistical 
analysis and user testing results public prior to publicly reporting 
any data on Physician Compare. Many commenters noted that it is 
important that the data included on Physician Compare be accurately 
understood by patients and caregivers.
    Response: We agree that accurate interpretation is of utmost 
importance, which is why one of our public reporting criteria states 
that all data must resonate with users to be included on the Web site, 
as determined by CMS through user testing. We also understand that more 
actively and frequently sharing the results of statistical testing and 
user testing can help continue our ongoing conversation with our 
stakeholders about the future of public reporting and Physician 
Compare. As a result, as noted, we will actively work to share the 
results of this testing with stakeholders through outreach and via the 
Physician Compare Initiative page on cms.gov prior to reporting the 
data each year.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal for year 2 of the Quality Payment Program (2018 
data available for public reporting in late 2019) and future years, to 
publicly report on Physician Compare, either on profile pages or in the 
downloadable database, the final score for each MIPS eligible clinician 
and the performance of each MIPS eligible clinician for each 
performance category, and to periodically post aggregate information on 
the MIPS, including the range of final scores for all MIPS eligible 
clinicians and the range of performance of all the MIPS eligible 
clinicians for each performance category, as technically feasible. We 
will use statistical testing and user testing, as well as consultation 
with the Physician Compare Technical Expert Panel convened by our 
contractor, to determine how and where these data are best reported on 
Physician Compare.
    A summary of the proposals related to each performance category of 
MIPS data follows.
b. Quality
(1) Generally
    As detailed in the CY 2017 Quality Payment Program final rule (81 
FR 77395), and consistent with the existing policy making all current 
PQRS measures available for public reporting, we finalized a decision 
to make all measures under the MIPS quality performance category 
available for public reporting on Physician Compare in the transition 
year of the Quality Payment Program, as technically feasible. This 
included all available measures reported via all available submission 
methods, and applied to both MIPS eligible clinicians and groups.
    Also consistent with current policy, although all measures will be 
available for public reporting, not all measures will be made available 
on the public-facing Web site profile pages. As explained in the CY 
2017 Quality Payment Program final rule (81 FR 77394), providing too 
much information can overwhelm Web site users and lead to poor decision 
making. Therefore, consistent with section 1848(q)(9)(A)(i)(II) of the 
Act, all measures in the quality performance category that meet the 
statistical public reporting standards will be included in the 
downloadable database, as technically feasible. We also finalized a 
policy that a subset of these measures will be publicly reported on the 
Web site's profile pages, as technically feasible, based on Web site 
user testing. We will use statistical testing and user testing to 
determine how and where measures are reported on Physician Compare. In 
addition, we adopted our existing policy of not publicly reporting 
first year measures, meaning new measures that have been in use for 
less than 1 year, regardless of submission method used, for the MIPS 
quality performance category. After a measure's first year in use, we 
will evaluate the measure to see if and when the measure is suitable 
for public reporting (81 FR 77395).
    Currently, there is a minimum sample size requirement of 20 
patients for performance data to be included on Physician Compare. In 
the CY 2017 Quality Payment Program final rule, we finalized 
instituting a minimum reliability threshold for public reporting data 
on Physician Compare starting with 2017 data available for public 
report in late 2018 and each year moving forward (81 FR 77395).
    We will conduct analyses to determine the reliability of the data 
collected and use this to calculate the minimum reliability threshold 
for the data. Once an appropriate minimum reliability threshold is 
determined, we will only publicly report those performance rates for 
any given measure that meet the minimum reliability threshold. We note 
that reliability standards for public reporting and reliability for 
scoring need not align; reliability for public reporting is unique 
because, for example, public reporting requires ensuring additional 
protections to maintain confidentiality. In addition, because publicly 
reported measures can be compared across clinicians and across groups, 
it is particularly important for the most stringent reliability 
standards to be in place to ensure differences in performance scores 
reflect true differences in quality of care to promote accurate 
comparisons by the public. For further information on reliability as it 
relates to scoring of cost measures see section II.C.7.a.(3) of this 
final rule with comment period.
    In the CY 2017 Quality Payment Program final rule, we established 
that we will include the total number of patients reported on each 
measure in the downloadable database to facilitate transparency and 
more accurate understanding and use of the data (81 FR 77395). We will 
begin publishing the total number of patients reported on each measure 
in the downloadable database with 2017 data available for public 
reporting in late 2018 and for each year moving forward.
    Understanding that we will continue our policies to not publicly 
report first year quality measures, that we will only report those 
measures that meet the reliability threshold and meet the public 
reporting standards, and include the total number of patients reported 
on for each measure in the downloadable database, we again proposed to 
make all

[[Page 53824]]

measures under the MIPS quality performance category available for 
public reporting on Physician Compare, as technically feasible (82 FR 
30166). This would include all available measures reported via all 
available submission methods for both MIPS eligible clinicians and 
groups, for 2018 data available for public reporting in late 2019, and 
for each year moving forward. Continuing to publicly report these data 
ensures continued transparency and provides people with Medicare and 
their caregivers valuable information they can use to make informed 
health care decisions. We requested comment on this proposal.
    The following is a summary of the public comments received on the 
``Quality'' proposals and our responses:
    Comment: Many commenters supported publicly reporting quality 
performance category data at the measure level, with one commenter 
noting that performance data helps patients select clinicians. One 
commenter encouraged user testing prior to public reporting to ensure 
that patients accurately understand the measures. Another commenter 
requested that CMS obtain multi-stakeholder feedback on the display of 
data prior to publication. Multiple commenters supported not publicly 
reporting first year quality measures. Several commenters requested 
that CMS not report quality measures for the first 3 years a measure is 
in use. One commenter requested additional time for rural and small 
practice clinicians to gain more experience with documentation 
improvement prior to having their quality data publicly reported.
    Response: We reiterate that all data available for public reporting 
on Physician Compare will be tested with users to ensure it meets our 
public reporting criteria and is accurately understood prior to being 
considered for publication. We agree that publicly reporting 
performance data helps patients select clinicians. Regarding the 
request for stakeholder input on measure display, we will continue to 
conduct outreach to provide opportunities for all stakeholders to 
provide input on the Web site outside of rulemaking, as appropriate. We 
encourage all stakeholders to contact the Physician Compare support 
team at [email protected] with any suggestions and feedback 
on Web site display. In addition, although we appreciate the desire to 
delay use of new measures beyond the first year, we also appreciate the 
need to provide Medicare patients and their caregivers useful 
information to make informed decisions. Withholding new measure data 
beyond the first year if all public reporting criteria are met prevents 
us from considering valuable new data for inclusion on the Web site in 
a timely manner. And, withholding data for rural and small practices 
would also prevent us from providing this useful information to the 
patients they serve. It is important to remember, however, that our 
public reporting standards do ensure data comparability, and our phased 
approach to public reporting ensures a gradual approach to reporting. 
Our reporting standards, and gradual approach to public reporting, will 
help ensure rural and small practices are accurately and appropriately 
represented.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to make all measures under the MIPS quality 
performance category available for public reporting on Physician 
Compare, either on profile pages or in the downloadable database, as 
technically feasible. This includes all available measures reported via 
all available submission methods for both MIPS eligible clinicians and 
groups, for year 2 of the Quality Payment Program (2018 data available 
for public reporting in late 2019) and future years. We will use 
statistical testing and user testing to determine how and where 
measures are reported on Physician Compare. We will also continue our 
policies to not publicly report first year quality measures, to only 
report those measures that meet the reliability threshold and meet the 
public reporting standards, and to include the total number of patients 
reported on for each measure in the downloadable database.
(2) Request for Comment on Patient Experience Narrative Data
    We sought comment on expanding the patient experience data 
available for public reporting on Physician Compare. Currently, the 
CAHPS for MIPS survey is available for groups to report under the MIPS. 
This patient experience survey data is highly valued by patients and 
their caregivers as they evaluate their health care options. However, 
in testing with patient and caregivers, they regularly ask for more 
information from patients like them in their own words. Patients 
regularly request that we include narrative reviews of clinicians and 
groups on the Web site. The Agency for Healthcare Research and Quality 
(AHRQ) is fielding a beta version of the CAHPS Patient Narrative 
Elicitation Protocol (https://www.ahrq.gov/cahps/surveys-guidance/item-sets/elicitation/index.html). This includes five open-ended questions 
designed to be added to the Clinician & Groups CAHPS survey, on which 
CAHPS for MIPS is modeled. These five questions have been developed and 
tested to work to capture patient narratives in a scientifically 
grounded and rigorous way, setting it apart from other patient 
narratives collected by various health systems and patient rating 
sites. More scientifically rigorous patient narrative data would not 
only greatly benefit patients, but it would also greatly aid clinicians 
and groups as they work to assess how their patients experience care. 
We also sought comment on potentially reporting these five open-ended 
questions for the CAHPS for MIPS survey on Physician Compare for 
consideration in future rulemaking. We direct readers to the Quality 
Performance Criteria in section II.C.6.b.(3)(a) of this final rule with 
comment period for additional information related to seeking comment on 
adding these questions to the CAHPS for MIPS survey.
    We received a number of comments on this item and appreciate the 
input received. As this was a request for comment only, we will take 
the feedback provided into consideration for possible inclusion in 
future rulemaking.
c. Cost
    Consistent with section 1848(q)(9)(A)(i)(II) of the Act, we 
finalized in the CY 2017 Quality Payment Program final rule a decision 
to make all measures under the MIPS cost performance category available 
for public reporting on Physician Compare (81 FR 77396). This included 
all available measures reported via all available submission methods, 
and applied to both MIPS eligible clinicians and groups. However, as 
noted in the final rule, we may not have data available for public 
reporting in the transition year of the Quality Payment Program for the 
cost performance category (2017 data available for public reporting in 
late 2018).
    As discussed in the final rule (81 FR 77395), cost data are 
difficult for patients to understand, and, as a result, publicly 
reporting these measures could lead to significant misinterpretation 
and misunderstanding. For this reason, we again proposed to include on 
Physician Compare a subset of cost measures that meet the public 
reporting standards, either on profile pages or in the downloadable 
database, if technically feasible, for 2018 data available for public 
reporting in late 2019, and for each year moving forward (82 FR 30167).
    These data are required by the MACRA to be available for public

[[Page 53825]]

reporting on Physician Compare, but we want to ensure we only share 
those cost measures on profile pages that can help patients and 
caregivers make informed health care decisions. For transparency 
purposes, the cost measures that meet all other public reporting 
standards would be included in the downloadable database. We would use 
statistical testing and Web site user testing to determine how and 
where measures are reported on Physician Compare to minimize passing 
the complexity of these measures on to patients and to ensure those 
measures included are accurately understood and correctly interpreted. 
Under this proposal, we noted that the policies we previously mentioned 
regarding first year measures, the minimum reliability threshold, and 
all public reporting standards would apply. The proposal applied to all 
available measures reported via all available submission methods, and 
to both MIPS eligible clinicians and groups. We requested comment on 
this proposal.
    The following is a summary of the public comments received on the 
``Cost'' proposal and our responses:
    Comment: Two commenters supported publicly reporting cost 
performance category data. These commenters supported user testing to 
ensure the cost data are accurately interpreted and of value to 
patients in their health care decision making. Multiple commenters did 
not support reporting cost performance category data, indicating 
concern that patients and caregivers cannot accurately interpret these 
data, and suggested caution especially in years when the cost 
performance category will be weighted at zero percent for MIPS scoring. 
If reported, multiple commenters supported not publicly reporting first 
year cost measures. Three commenters requested that CMS not report cost 
measures for the first 3 years a measure is in use. One commenter 
suggested that CMS provide the specific subset of cost measures under 
consideration for public reporting for public comment. Other commenters 
suggested that cost measures be linked to quality measures to better 
demonstrate value.
    Response: We understand the commenters' concerns that patients and 
caregivers cannot accurately interpret these data. As noted, we 
appreciate that these data can be difficult to interpret, and 
therefore, extensive user testing is planned to ensure that any cost 
measure considered for public reporting meets all public reporting 
standards, including resonating with Web site users.
    We agree it is best to continue to not report first year cost 
measures, but as with quality measures, we believe that delaying 
consideration for inclusion if all public reporting criteria are met 
beyond the first year could unnecessarily prevent us from including 
valuable, timely information on the Web site. Through the rulemaking 
process, which provides an opportunity to comment on the universe of 
cost measures available for public reporting, and through stakeholder 
outreach and the 30-day preview period, we will provide ample 
opportunity for stakeholders to review the available data and provide 
feedback.
    We will take the recommendation to link quality and cost data under 
consideration and evaluate feasibility for including this in future 
rulemaking.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to include on Physician Compare a subset of 
cost measures that meet the public reporting standards, either on 
profile pages or in the downloadable database, if technically feasible, 
for year 2 of the Quality Payment Program (2018 data available for 
public reporting in late 2019) and future years. We will use 
statistical testing and Web site user testing to determine how and 
where measures are reported on Physician Compare. We will continue our 
policies to not publicly report first year quality measures, and we 
will only report those measures that meet the reliability threshold and 
meet the public reporting standards. This includes all available 
measures reported via all available submission methods, and applies to 
both MIPS eligible clinicians and groups.
d. Improvement Activities
    Consistent with section 1848(q)(9)(A)(i)(II) of the Act, we 
finalized a decision to make all activities under the MIPS improvement 
activities performance category available for public reporting on 
Physician Compare (81 FR 77396). This included all available 
improvement activities reported via all available submission methods, 
and applied to both MIPS eligible clinicians and groups.
    Consistent with the policy finalized for the transition year, we 
again proposed to include a subset of improvement activities data on 
Physician Compare that meet the public reporting standards, either on 
the profile pages or in the downloadable database, if technically 
feasible, for 2018 data available for public reporting in late 2019, 
and for each year moving forward (82 FR 30167). This again includes all 
available activities reported via all available submission methods, and 
applies to both MIPS eligible clinicians and groups. For those eligible 
clinicians or groups that successfully meet the improvement activities 
performance category requirements, this information will be posted on 
Physician Compare as an indicator. This information is required by the 
MACRA to be available for public reporting on Physician Compare, but 
the improvement activities performance category is a new field of data 
for Physician Compare, so concept and Web site user testing is still 
needed to ensure these data are understood by stakeholders. Therefore, 
we again proposed that we would use statistical testing and user 
testing to determine how and where improvement activities are reported 
on Physician Compare, as appropriate.
    For the transition year, we excluded first year activities from 
public reporting (81 FR 77396). First year activities are any 
improvement activities in their first year of use. Starting with year 2 
(2018 data available for public reporting in late 2019), we proposed 
publicly reporting first year activities if all other public reporting 
criteria are satisfied. This evolution in our Quality Payment Program 
public reporting plan provides an opportunity to make more valuable 
information public given that completion of or participation in first 
year activities is different from reporting first year quality or cost 
measures. Clinicians and groups can learn from the first year of 
quality and cost data, understand why their performance rate is what it 
is, and take time to improve. A waiting period for indicating 
completion or participation in an improvement activity is unlikely to 
produce the same benefit. We requested comments on these proposals.
    The following is a summary of the public comments received on the 
``Improvement Activities'' proposals and our responses:
    Comment: Some commenters supported reporting improvement activity 
information, including first year activities. However, several 
commenters did not support reporting improvement activity information. 
Multiple commenters noted CMS should add new data, such as improvement 
activities, to Physician Compare gradually. One commenter noted that 
improvement activity information should be withheld from public 
reporting until statistical and user testing could be completed to 
confirm accuracy. Other commenters noted that CMS should gain more 
experience with improvement activity information before publicly 
reporting it.

[[Page 53826]]

    Response: The primary concerns raised regarding publicly reporting 
improvement activities information focused on the need for statistical 
and user testing and concern regarding whether patients and caregivers 
would accurately understand this information. We have already started 
testing this data with Web site users and have found that this data is 
not only easily understood but believed to be of great value to Web 
site users. Many of the activities included in the program resonate 
with users and provide them with valuable information in their decision 
making process. In addition, as noted, because we are just indicating 
if an activity was completed and not also reporting performance on the 
activity, we do not find added benefit in waiting beyond year 2 of the 
Quality Payment Program to report first year activities. As with all 
data under consideration for inclusion on Physician Compare, we are 
looking to include data per our phased approach recognizing the need to 
add new data gradually.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to include a subset of improvement activities 
data on Physician Compare that meet the public reporting standards, 
either on the profile pages or in the downloadable database, if 
technically feasible, for year 2 of the Quality Payment Program (2018 
data available for public reporting in late 2019 and future years. This 
includes all available activities reported via all available submission 
methods, and applies to both MIPS eligible clinicians and groups. For 
those eligible clinicians or groups that successfully meet the 
improvement activities performance category requirements, this 
information will be posted on Physician Compare as an indicator. We are 
also finalizing our proposal that we will use statistical testing and 
user testing to determine how and where improvement activities are 
reported on Physician Compare, as appropriate.
    We are also finalizing our proposal, for year 2 of the Quality 
Payment Program (2018 data available for public reporting in late 2019) 
and future years, to publicly reporting first year activities if all 
other public reporting criteria are satisfied.
e. Advancing Care Information
    Since the beginning of the EHR Incentive Programs in 2011, 
participant performance data has been publicly available in the form of 
public use files on the CMS Web site. In the 2015 EHR Incentive 
Programs final rule (80 FR 62901), we addressed comments requesting 
that we not only continue this practice but also include a wider range 
of information on participation and performance. In that rule, we 
stated our intent to publish the performance and participation data on 
Stage 3 objectives and measures of meaningful use in alignment with 
quality programs which utilize publicly available performance data such 
as Physician Compare. At this time there is only an indicator on 
Physician Compare profile pages to show that an eligible clinician 
successfully participated in the current Medicare EHR Incentive 
Program.
    As MIPS will include advancing care information as one of the four 
MIPS performance categories, we decided, consistent with section 
1848(q)(9)(i)(II) of the Act, to include more information on an 
eligible clinician's or group's performance on the objectives and 
measures of meaningful use on Physician Compare for the transition year 
(81 FR 77387). An important consideration was that to meet the public 
reporting standards, the data added to Physician Compare must resonate 
with Medicare patients and their caregivers. Testing to date has shown 
that people with Medicare value the use of certified EHR technology and 
see EHR use as something that if used well can improve the quality of 
their care. In addition, we believe the inclusion of indicators for 
clinicians and groups who achieve high performance in key care 
coordination and patient engagement activities provide significant 
value for patients and their caregivers as they make health care 
decisions.
    Consistent with our transition year final policy, and understanding 
the value of this information to Web site users, we again proposed to 
include an indicator on Physician Compare for any eligible clinician or 
group who successfully meets the advancing care information performance 
category, as technically feasible (82 FR 30168). Also, as technically 
feasible, we proposed to include additional indicators, including but 
not limited to, objectives, activities, or measures specified in 
section II.C.6.f. of the proposed rule (see 82 FR 30057 through 30080), 
such as identifying if the eligible clinician or group scores high 
performance in patient access, care coordination and patient 
engagement, or health information exchange. The proposals applied to 
2018 data available for public reporting in late 2019, and for each 
year moving forward, as this information is required by the MACRA to be 
available for public reporting on Physician Compare. We also proposed 
that any advancing care information objectives, activities, or measures 
would need to meet the public reporting standards applicable to data 
posted on Physician Compare, either on the profile pages or in the 
downloadable database. This would include all available objectives, 
activities, or measures reported via all available submission methods, 
and would apply to both MIPS eligible clinicians and groups. We would 
use statistical testing and Web site user testing to determine how and 
where objectives and measures are reported on Physician Compare.
    As with improvement activities, we also proposed to allow first 
year advancing care information objectives, activities, and measures to 
be available for public reporting starting in year 2 (2018 data 
available for public reporting in late 2019). Again, especially if we 
are including an indicator over a performance rate, the benefits of 
waiting 1 year are not the same and thus, we believe it is more 
important to make more information available for public reporting as 
the Quality Payment Program matures. We requested comment on these 
proposals.
    The following is a summary of the public comments received on the 
``Advancing Care Information'' proposals and our responses:
    Comment: Several commenters supported including advancing care 
information as proposed and noted that including advancing care 
information as indicators rather than performance rates will aid 
accurate interpretation of the information. Other commenters requested 
clarification regarding what would constitute ``high'' and ``low'' 
performance or ``successful completion'' of the advancing care 
information performance category. One commenter did not support 
reporting an indicator for ``low'' performance. If ``successful 
completion'' was defined as attaining the base score, one commenter 
supported its inclusion as an indicator. This commenter did not, 
however, support reporting an indicator for ``high'' performance. 
Another commenter requested clarification as to whether Physician 
Compare would indicate whether 2014 or 2015 CEHRT was used to meet 
``successful completion.''
    Response: We appreciate the support for including advancing care 
information as indicators on Physician Compare as we know patients and 
caregivers find value in this information. We also appreciate concerns 
around indicating ``low'' performance in the early years of the Quality 
Payment Program. To clarify, ``successful completion'' of this 
performance category will be defined as obtaining the base score of 50 
percent, as supported by commenters. ``High''

[[Page 53827]]

performance will be defined as obtaining a score of 100 percent. 
Because the information is technically complex and of less value to the 
average patient and caregiver, we will not indicate the version of 
CEHRT used on Physician Compare, but we will evaluate this further to 
see if there is value in adding it to the documentation for the 
clinicians and groups reporting the data and/or third parties using the 
data.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal, for year 2 of the Quality Payment Program 
(2018 data available for public reporting in 2019) and future years, to 
include an indicator on Physician Compare for any eligible clinician or 
group who successfully meets the advancing care information performance 
category, as technically feasible. We are also finalizing our proposal 
to include, as technically feasible, additional information, including 
but not limited to, objectives, activities, or measures specified in 
section II.C.6.f. of this final rule with comment period. We are 
finalizing that we will indicate ``high'' performance, as technically 
feasible and appropriate, but we will not indicate ``low'' performance 
in year 2 of the Quality Payment Program (2018 data available for 
public reporting in late 2019). We will revisit the value of indicating 
``low'' performance for possible consideration in future rulemaking.
    We are also finalizing our proposal that any advancing care 
information objectives, activities, or measures will need to meet the 
public reporting standards applicable to data posted on Physician 
Compare, either on the profile pages or in the downloadable database. 
This will include all available objectives, activities, or measures 
reported via all available submission methods, and will apply to both 
MIPS eligible clinicians and groups. We will use statistical testing 
and Web site user testing to determine how and where objectives, 
activities, and measures are reported on Physician Compare.
    In addition, we are finalizing our proposal to allow first year 
advancing care information objectives, activities, and measures to be 
available for public reporting for year 2 of the Quality Payment 
Program (2018 data available for public reporting in late 2019) and 
future years, as appropriate.
f. Achievable Benchmark of Care (ABCTM)
    Benchmarks are important to ensuring that the quality data 
published on Physician Compare are accurately understood. A benchmark 
allows Web site users to more easily evaluate the information published 
by providing a point of comparison between groups and between 
clinicians. In the CY 2016 PFS final rule (80 FR 71129), we finalized a 
decision to publicly report on Physician Compare an item, or measure-
level, benchmark by submission mechanism, using the Achievable 
Benchmark of Care (ABCTM) \14\ methodology annually based on 
the PQRS performance rates most recently available by submission 
mechanism. As a result, in late 2017, we expect to publicly report a 
benchmark based on the 2016 PQRS performance rates for each measure by 
each available submission mechanism for a subset of measures that meet 
the necessary public reporting standards and the added reliability 
testing necessary to determine the benchmark and the resulting star 
rating cut-offs. The specific measures for which the benchmark will be 
calculated will be determined once the data are available and analyzed.
---------------------------------------------------------------------------

    \14\ Kiefe CI, Weissman NW, Allison JJ, Farmer R, Weaver M, 
Williams OD. Identifying achievable benchmarks of care: concepts and 
methodology. International Journal of Quality Health Care. 1998 Oct; 
10(5):443-7.
---------------------------------------------------------------------------

    We believe ABCTM is a well-tested, data-driven 
methodology that allows us to account for all of the data collected for 
a quality measure, evaluate who the top performers are, and then use 
that to set a point of comparison for all of those clinicians or groups 
who report the measure. ABCTM starts with the pared-mean, 
which is the mean of the best performers on a given measure for at 
least 10 percent of the patient population--not the population of 
reporters. To find the pared-mean, we will rank order clinicians or 
groups (as appropriate per the measure being evaluated) in order from 
highest to lowest performance score. We will then subset the list by 
taking the best performers moving down from best to worst until we have 
selected enough reporters to represent 10 percent of all patients in 
the denominator across all reporters for that measure.
    We finalized that the benchmark would be derived by calculating the 
total number of patients in the highest scoring subset receiving the 
intervention or the desired level of care, or achieving the desired 
outcome, and dividing this number by the total number of patients that 
were measured by the top performing doctors. This would produce a 
benchmark that represents the best care provided to the top 10 percent 
of patients by measure, by submission mechanism.
    An Example: A clinician reports on how many patients with diabetes 
she has given foot exams. There are four steps to establishing the 
benchmark for this measure.
    (1) We look at the total number of patients with diabetes for all 
clinicians who reported this diabetes measure.
    (2) We rank clinicians that reported this diabetes measure from 
highest performance score to lowest performance score to identify the 
set of top clinicians who treated at least 10 percent of the total 
number of patients with diabetes.
    (3) We count how many of the patients with diabetes who were 
treated by the top clinicians also got a foot exam.
    (4) This number is divided by the total number of patients with 
diabetes who were treated by the top clinicians, producing the 
ABCTM benchmark.
    To account for low denominators, ABCTM suggests the 
calculation of an adjusted performance fraction (AFP) using a Bayesian 
Estimator or use of another statistical methodology. After analysis, we 
have determined that the use of a beta binomial model adjustment is 
most appropriate for the type of data we are working with. The beta 
binomial method moves extreme values toward the average for a given 
measure, while the Bayesian Estimator moves extreme values toward 50 
percent. Using the beta binomial method is a more methodologically 
sophisticated approach to address the issue of extreme values based on 
small sample sizes. This ensures that all clinicians are accounted for 
and appropriately figured in to the benchmark.
    The benchmarks for Physician Compare developed using the 
ABCTM methodology will be based on the current year's data, 
so the benchmark will be appropriate regardless of the unique 
circumstances of data collection or the measures available in a given 
reporting year. We also finalized (80 FR 71129) a decision to use the 
ABCTM methodology to generate a benchmark which will be used 
to systematically assign stars for the Physician Compare 5-star rating. 
We conducted outreach with stakeholders, and consulted CMS programs, 
measure experts, and the Physician Compare Technical Expert Panel 
convened by our contractor to determine the best method for determining 
the 5-star categories based on the benchmark. This consultation in 
combination with extensive analysis led us to a decision to use the 
equal ranges method.
    During outreach, stakeholders expressed the importance of assigning 
star ratings in a way that is understandable to Web site users. The 
equal ranges method is intuitive to

[[Page 53828]]

interpret, and has tested well with patients and caregivers. We also 
repeatedly heard from stakeholders that we should choose a method of 
assigning stars that reflects true performance on the measure rather 
than forcing a distribution. Our testing has shown that the equal 
ranges method best reflects true performance on the measure. Our 
analyses also show that the equal ranges method generates more stable 
star rating cut-offs than the other methods we evaluated. Additionally, 
we expect star rating assignments based on the equal ranges method to 
be more stable across years allowing the ability to better assess year-
to-year performance. The equal ranges method also provides a more 
reliable and meaningful classification than other methods evaluated. In 
this way, using equal ranges ensures that a 4-star performance is 
statistically better than and distinct from a 3-star performance on a 
measure and so forth.
    After we determine the benchmark using the ABCTM 
methodology for a given measure, and determine that the benchmark meets 
our public reporting standards, we move on to assigning star ratings. 
Any clinicians or groups who meet or exceed the benchmark by measure, 
by mechanism, will be assigned 5-stars for the measure. Next, we use 
the equal ranges method to assign 1 to 4 stars. The equal ranges method 
is based on the difference between the benchmark and the lowest 
performance score for a given measure and uses that range to assign 1 
to 4 stars.
    Clinicians or groups who meet or exceed the established benchmark 
for a measure will be assigned 5-stars. To determine the 4-star cut-off 
using the equal ranges method, we subtract the lowest performance score 
from the benchmark to get the range of performance scores, and then 
divide by 4 to get quarters. The 4-star cut-off is one quarter of the 
distance between the ABCTM benchmark and the lowest 
performance score. Clinicians or groups who score at or above the 4-
star cut-off, but below the benchmark will be assigned 4 stars. The 3-
star cut-off is two quarters of the distance between the benchmark and 
lowest performance score. Clinicians or groups who score at or above 
the 3-star cut-off but below the 4-star cut-off are assigned 3 stars. 
We follow the same method to get the 2-star cut-off, which is 3 
quarters of the distance between the benchmark and the lowest 
performance score. Finally, any scores that are greater than three 
quarters of the distance between the benchmark and the lowest 
performance score are assigned 1 star.
    More information about this star attribution method can also be 
found on the Physician Compare Initiative page on cms.gov. As part of 
our phased approach to public reporting, we expect to publicly report 
the benchmark and 5-star rating for the first time on Physician Compare 
in late 2017 using the 2016 PQRS performance scores for a subset of 
available group-level measures.
    As a result of stakeholder feedback asking that we consider one 
consistent approach for benchmarking and parsing the data based on the 
benchmark across the Quality Payment Program, we did consider an 
alternative approach. We reviewed the benchmark and decile breaks being 
used to assign points and determine payment under MIPS (see 82 FR 30168 
through 30169). This approach was not considered ideal for public 
reporting for several reasons. A primary concern was that the decile 
approach when used for public reporting would force a star rating 
distribution inconsistent with the raw distribution of scores on a 
given measure. If applied to star ratings, there would need to be an 
equal distribution of clinicians in each of the star rating categories.
    Using the ABCTM methodology for the benchmark sets the 
5-star rating at the performance rate that is the best achievable rate 
in the current clinical climate based on the current set of measures 
and the current universe of reporters. The star ratings are then 
derived from there consistent with the raw score distribution. In this 
way, if the majority of clinicians performed well on a measure, the 
majority would receive a high star rating. If we used the decile 
approach some clinicians would be reported as having a ``low'' star 
rating despite their relative performance on the measure.
    It is not always ideal to use the same methodology across the 
program as scoring for payment purposes may be designed in a somewhat 
different way that may incorporate factors that are not necessarily as 
applicable for public reporting, while the key consideration for public 
reporting is that the methodology used best helps patients and 
caregivers easily interpret the data accurately. Testing with Web site 
users has shown that the star rating based on the ABCTM 
benchmark helps patients and caregivers interpret the data accurately.
    ABCTM has been historically well received by the 
clinicians and entities it is measuring because the benchmark 
represents quality while being both realistic and achievable; it 
encourages continuous quality improvement; and, it is shown to lead to 
improved quality of care.15 16 17 Appreciating this and the 
support this methodology received in previous rulemaking and throughout 
our outreach process to date, we again proposed to use the 
ABCTM methodology to determine a benchmark for the quality, 
cost, improvement activities, and advancing care information data, as 
feasible and appropriate, by measure and by submission mechanism for 
each year of the Quality Payment Program, starting with the transition 
year data (2017 data available for public reporting in late 2018) (82 
FR 30169). We also proposed to use this benchmark to determine a 5-star 
rating for each MIPS measure, as feasible and appropriate. As 
previously finalized, only those measures that meet the public 
reporting standards would be considered, and the benchmark would be 
based on the most recently available data.
---------------------------------------------------------------------------

    \15\ Kiefe CI, Weissman NW, Allison JJ, Farmer R, Weaver M, 
Williams OD. Identifying achievable benchmarks of care: concepts and 
methodology. International Journal of Quality Health Care. 1998 Oct; 
10(5):443-7.
    \16\ Kiefe CI, Allison JJ, Williams O, Person SD, Weaver MT, 
Weissman NW. Improving Quality Improvement Using Achievable 
Benchmarks For Physician Feedback: A Randomized Controlled Trial. 
JAMA. 2001;285(22):2871-2879.
    \17\ Wessell AM, Liszka HA, Nietert PJ, Jenkins RG, Nemeth LS, 
Ornstein S. Achievable benchmarks of care for primary care quality 
indicators in a practice-based research network. American Journal of 
Medical Quality 2008 Jan-Feb;23(1):39-46.
---------------------------------------------------------------------------

    We believe that displaying the appropriate and relevant MIPS data 
in this user-friendly format provides more opportunities to present 
these data to people with Medicare in a way that is most likely to be 
accurately understood and interpreted. We requested comment on these 
proposals.
    The following is a summary of the public comments received on the 
``Achievable Benchmark of Care (ABCTM)'' proposals and our 
responses:
    Comment: Many commenters supported the proposals with caveats. 
Commenters requested a phased approach to publicly reporting the star 
ratings based on the ABCTM benchmark. Also, commenters asked 
that we share additional information about the equal ranges method, the 
use of the beta binomial, and more data to understand the overall 
approach, specifically as it relates to measures that do not have much 
variation in performance rates. Commenters also stressed the importance 
of deriving the benchmark by measure and submission mechanism. In 
addition, commenters indicated the importance of ample Web site user 
testing to ensure the resulting star rating was fully understood by 
patients and caregivers. Multiple commenters also

[[Page 53829]]

supported using the ABCTM methodology instead of the decile 
approach for purposes of MIPS scoring. Three commenters raised concerns 
that not having clinicians broken out by subspecialty or not having 
more subspecialty specific measures meant that some comparisons may not 
be appropriate. Specifically, concerns were raised in relation to 
emergency department doctors, retina specialists, and psychiatrists.
    Response: We appreciate that many commenters would like to move 
forward with the ABCTM benchmark and resulting star rating 
via a phased approach. Just as we started the process of public 
reporting with a phased approach, we intend to reset and apply the same 
phased approach to public reporting measures as star ratings. 
Understanding the additional information requested about the equal 
ranges method, the use of the beta binomial, and more data to 
understand the overall approach, specifically as it relates to measures 
that do not have much variation in performance rates, resources have 
been added to the Physician Compare Initiative page that cover these 
topics and explain the benchmark methodology and the star rating 
attribution process using the equal ranges method. Also, consistent 
with our position to actively share additional information on analysis 
and user testing and our overall approach to implementing star ratings 
based on the ABCTM benchmark, more information about the 
analysis conducted in preparation for the release of the first star 
ratings is being made available to stakeholders via the Physician 
Compare Initiative page on cms.gov. User testing results will also be 
made available to address concerns about the need for sufficient user 
testing prior to reporting star ratings. As previously finalized and as 
proposed (82 FR 30169), the benchmark is being derived by measure and 
by submission mechanism, which is consistent with commenters' requests.
    We also appreciate the commenters' support for using the 
ABCTM methodology instead of the decile approach for 
purposes of MIPS scoring. We will take this recommendation into 
consideration for the future. However, we do reiterate that it is not 
always ideal or necessary to use the same methodology for scoring and 
public reporting given the unique considerations and goals of each. 
Testing with Web site users has shown that the star rating based on the 
ABCTM benchmark helps patients and caregivers interpret the 
data accurately, which is the main goal of public reporting.
    Regarding the commenters' concerns that not having clinicians 
broken out by subspecialty or not having more subspecialty specific 
measures means that some comparisons may not be appropriate with 
respect to certain subspecialties, we note that all searches on 
Physician Compare are by specialty and location. Therefore, there is 
some level of stratification by specialty for Web site users. We do 
appreciate the desire for more detailed specialty-level information. 
However, at this time, this level of detailed information--subspecialty 
information--is not available through the Provider Enrollment, Chain, 
and Ownership System (PECOS), the sole source of specialty information 
available to Physician Compare, and thus not available for use on 
Physician Compare. We will, however, continue to evaluate options for 
providing more sub-specialty level information for future 
consideration, as feasible.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to use the ABCTM methodology to 
determine a benchmark for the quality, cost, improvement activities, 
and advancing care information data, as feasible and appropriate, by 
measure and by submission mechanism for each year of the Quality 
Payment Program, starting with the transition year (2017 data available 
for public reporting in late 2018) and each year forward. We are also 
finalizing our proposal to use this benchmark as the basis of a 5-star 
rating for each available measure, as feasible and appropriate. Only 
those measures that meet the public reporting standards will be 
considered for benchmarking and star ratings, and the benchmark will be 
based on the most recently available data each year.
g. Voluntary Reporting
    In CY 2017 Quality Payment Program proposed rule (81 FR 28291), we 
solicited comment on the advisability and technical feasibility of 
including on Physician Compare data voluntarily reported by eligible 
clinicians and groups that are not subject to MIPS payment adjustments, 
such as excluded clinician types, to be addressed through separate 
notice-and-comment rulemaking.
    As indicated in the CY 2017 Quality Payment Program final rule (81 
FR 77394), comments received were favorable overall. Stakeholders 
generally support clinicians and groups being permitted to have data 
available for public reporting when submitting these data voluntarily 
under MIPS. As a result, we proposed starting with year 2 of the 
Quality Payment Program (2018 data available for public reporting in 
2019) and for each year moving forward, to make available for public 
reporting all data submitted voluntarily across all MIPS performance 
categories, regardless of submission method, by eligible clinicians and 
groups that are not subject to the MIPS payment adjustments, as 
technically feasible (82 FR 30169).
    If an eligible clinician or group that is not subject to the MIPS 
payment adjustments chooses to submit quality, cost (if applicable), 
improvement activity, or advancing care information, these data would 
become available for public reporting. However, because these data 
would be submitted voluntarily, we proposed that during the 30-day 
preview period, these eligible clinicians and groups would have the 
option to opt out of having their data publicly reported on Physician 
Compare. If eligible clinicians and groups do not take the action to 
opt out at this time, their data would be available for inclusion on 
Physician Compare if the data meet all previously stated public 
reporting standards and the minimum reliability threshold. As eligible 
clinicians and groups that are not required to report under MIPS, 
particularly in the first years of the Quality Payment Program, are 
taking additional steps to show their commitment to quality care, we 
want to ensure they have the opportunity to report their data and have 
it included on Physician Compare. We requested comment on the proposal.
    The following is a summary of the public comments received on the 
``Voluntary Reporting'' proposals and our responses:
    Comment: Many commenters supported this proposal to allow 
voluntarily reported data to be included on Physician Compare. However, 
some commenters supported an ``opt in'' versus an ``opt out'' approach 
during the 30-day preview period. One commenter recommended that CMS 
only publicly report the information for which it is legally mandated 
and that posting too much information could be confusing for patients.
    Response: We do understand the support for an ``opt in'' versus an 
``opt out'' approach during the 30-day preview period. However, we also 
appreciate that voluntary reporters (that is, eligible clinicians and 
groups that are not subject to the MIPS payment adjustments) are 
already taking additional steps to provide their data to CMS and 
believe it is reasonable to presume based on previously received 
comments and feedback that such

[[Page 53830]]

reporters want to have their data included on Physician Compare. Given 
the additional burden an ``opt in'' approach would impose and the value 
these data provide to users, we will move forward with the ``opt out'' 
approach as proposed. As with all data considering for inclusion on 
Physician Compare, we will conduct user testing to ensure that any 
additional data considered for the Web site are clear and add value to 
the user's Web site experience.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal for year 2 of the Quality Payment Program (2018 
data available for public reporting in 2019) and future years, to make 
available for public reporting all data submitted voluntarily across 
all MIPS performance categories, regardless of submission method, by 
eligible clinicians and groups that are not subject to the MIPS payment 
adjustments, as technically feasible. If an eligible clinician or group 
that is not subject to the MIPS payment adjustments chooses to submit 
quality, cost (if applicable), improvement activity, or advancing care 
information, these data will become available for public reporting. We 
are also finalizing our proposal that during the 30-day preview period, 
these eligible clinicians and groups will have the option to opt out of 
having their data publicly reported on Physician Compare. If eligible 
clinicians and groups do not actively take the action to opt out at 
this time, their data will be available for inclusion on Physician 
Compare if the data meet all public reporting standards and the minimum 
reliability threshold.
h. APM Data
    Section 1848(q)(9)(A)(ii) of the Act requires us to publicly report 
names of eligible clinicians in Advanced APMs and, to the extent 
feasible, the names and performance of Advanced APMs. We see this as an 
opportunity to continue to build on the ACO reporting we are now doing 
on Physician Compare. At this time, if a clinician or group submitted 
quality data as part of an ACO, there is an indicator on the 
clinician's or group's profile page indicating this. In this way, it is 
known which clinicians and groups participated in an ACO. Also, 
currently, all ACOs have a dedicated page on the Physician Compare Web 
site to showcase their data. For the transition year of the Quality 
Payment Program, we decided to use this model as a guide as we add APM 
data to Physician Compare. Specifically, we finalized a policy to 
indicate on eligible clinician and group profile pages of Physician 
Compare when the eligible clinician or group is participating in an APM 
(81 FR 77398). We also finalized a decision to link eligible clinicians 
and groups to their APM's data, as technically feasible, through 
Physician Compare. The finalized policy provides the opportunity to 
publicly report data for both Advanced APMs and APMs that are not 
considered Advanced APMs for the transition year, as technically 
feasible.
    At the outset, APMs will be very new concepts for Medicare patients 
and their caregivers. In these early years, indicating who participated 
in APMs and testing language to accurately explain that to Web site 
users provides useful and valuable information as we continue to evolve 
Physician Compare. As we come to understand how to best explain this 
concept to patients and their caregivers, we can continue to assess how 
to most fully integrate these data on the Web site. Understanding this 
and understanding the value of adding APM data to Physician Compare, we 
again proposed to publicly report names of eligible clinicians in 
Advanced APMs and the names and performance of Advanced APMs and APMs 
that are not considered Advanced APMs related to the Quality Payment 
Program starting with year 2 (2018 data available for public reporting 
in late 2019), and for each year moving forward, as technically 
feasible (82 FR 30170). In addition, we again proposed to continue to 
find ways to more clearly link clinicians and groups and the APMs they 
participate in on Physician Compare, as technically feasible. We 
requested comment on the proposals.
    The following is a summary of the public comments received on the 
``APM Data'' proposals and our responses:
    Comment: Two commenters expressed support for CMS' thoughtful and 
measured approach to reporting APM data and continuing to find ways to 
more clearly explain the intricacies of APMs to patients and 
caregivers. Another commenter requested clarification whether CMS will 
publish, for Advanced APM participants and participants of APMs that 
are not considered Advanced APMs, a total performance score or only 
performance scores at the measure-level.
    Response: We appreciate the support of our efforts to continue 
publishing APM performance information on Physician Compare in a way 
that will be meaningful for patients and caregivers. Regarding whether 
we will publish, for Advanced APMs and APMs that are not considered 
Advanced APMs, a total performance score or only performance scores at 
the measure-level, with the exception of data that must be mandatorily 
reported on Physician Compare, this will be determined based on 
statistical and user testing, and in consultation with the Physician 
Compare Technical Expert Panel convened by our contractor. As noted 
above, section 1848(q)(9)(A)(i)(I) of the Act requires that we publicly 
report on Physician Compare each MIPS eligible clinician's final score 
and performance category scores. As with all data considered for 
inclusion on Physician Compare, these data must also meet our public 
reporting standards to be publicly reported.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to publicly report names of eligible clinicians 
in Advanced APMs and the names and performance of Advanced APMs and 
APMs that are not considered Advanced APMs related to the Quality 
Payment Program for year 2 of the Quality Payment Program (2018 data 
available for public reporting in late 2019) and future years, as 
technically feasible. We are also finalizing our proposal to continue 
to find ways to more clearly link clinicians and groups and the APMs 
they participate in on Physician Compare, as technically feasible.
i. Stratification by Social Risk Factors
    We understand that social risk factors such as income, education, 
race and ethnicity, employment, disability, community resources, and 
social support play a major role in health. One of our core objectives 
is to improve the outcomes of people with Medicare, and we want to 
ensure that complex patients, as well as those with social risk factors 
receive excellent care. In addition, we seek to ensure that all 
clinicians are treated as fairly as possible within all CMS programs. 
In the CY 2017 Quality Payment Program final rule (81 FR 77395), we 
noted that we would review the first of several reports by the Office 
of the Assistant Secretary for Planning and Evaluation (ASPE) \18\. In 
addition, we have been reviewing the report of the National Academies 
of Sciences, Engineering, and Medicine on the issue of accounting for 
social risk factors in CMS programs.\19\ ASPE's first report, as 
required by the Improving Medicare

[[Page 53831]]

Post-Acute Care Treatment (IMPACT) Act, was released on December 21, 
2016, and analyzed the effects of social risk factors of people with 
Medicare on clinician performance under nine Medicare value-based 
purchasing programs. A second report due in October 2019 will expand on 
these initial analyses, supplemented with non-Medicare datasets to 
measure social risk factors. The National Academies of Sciences, 
Engineers, and Medicine released its fifth and final report on January 
10, 2017, and provided various potential methods for accounting for 
social risk factors, including stratified public reporting, as well as 
recommended next steps.
---------------------------------------------------------------------------

    \18\ ASPE, ``Report to Congress: Social Risk Factors and 
Performance Under Medicare's Value-Based Purchasing Programs.'' 21 
Dec 2016. Available at https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
    \19\ National Academies of Sciences, Engineering, and Medicine. 
2017. Accounting for social risk factors in Medicare payment. 
Washington, DC: The National Academies Press.
---------------------------------------------------------------------------

    As we continue to consider the analyses and recommendations from 
these and any future reports, we look forward to working with 
stakeholders in this process. Therefore, we sought comment only on 
accounting for social risk factors through public reporting on 
Physician Compare (82 FR 30170). Specifically, we sought comment on 
stratified public reporting by risk factors and ask for feedback on 
which social risk factors or indicators should be used and from what 
sources. Examples of social risk factor indicators include but are not 
limited to dual eligibility/low-income subsidy, race and ethnicity, 
social support, and geographic area of residence. We also sought 
comment on the process for accessing or receiving the necessary data to 
facilitate stratified reporting. Finally, we sought comment on whether 
strategies such as confidential reporting of stratified rates using 
social risk factor indicators should be considered in the initial years 
of the Quality Payment Program in lieu of publicly reporting stratified 
performance rates for quality and cost measures under the MIPS on 
Physician Compare. We sought comment only on these items for possible 
consideration in future rulemaking.
    The following is a summary of the public comments received on the 
``Stratification by Social Risk Factors'' request for comment:
    We received a number of comments on this item and appreciate the 
input received. As this was a request for comment only, we will take 
the feedback provided into consideration for possible inclusion in 
future rulemaking.
j. Board Certification
    Finally, we proposed adding additional Board Certification 
information to the Physician Compare Web site (82 FR 30170). Board 
Certification is the process of reviewing and certifying the 
qualifications of a physician or other clinician by a board of 
specialists in the relevant field. We currently include American Board 
of Medical Specialties (ABMS), American Osteopathic Association (AOA), 
and American Board of Optometry (ABO) data as part of clinician 
profiles on Physician Compare. We appreciate that there are additional, 
well respected boards that are not included in the ABMS, AOA, and ABO 
data currently available on Physician Compare that represent clinicians 
and specialties included on the Web site. Such board certification 
information is of interest to users as it provides additional 
information to use to evaluate and distinguish between clinicians on 
the Web site, which can help in making an informed health care 
decision. The more data of immediate interest that is included on 
Physician Compare, the more users will come to the Web site and find 
data that can help them make informed decisions. Please note we are not 
endorsing any particular boards.
    Another board, the American Board of Wound Medicine and Surgery 
(ABWMS), has shown interest in being added to Physician Compare and 
have demonstrated that they have the data to facilitate inclusion of 
this information on the Web site. We believe this board fills a gap for 
a specialty that is not currently covered by the ABMS, so we proposed 
to add ABWMS Board Certification information to Physician Compare.
    Additionally, for all years moving forward, for any board that 
would like to be considered for addition to the Physician Compare Web 
site, we proposed to establish a process for reviewing interest from 
these boards as it is brought to our attention on a case-by-case basis, 
and selecting boards as possible sources of additional board 
certification information for Physician Compare. We further proposed 
that, for purposes of CMS's selection, the board would need to 
demonstrate that it: fills a gap in currently available board 
certification information listed on Physician Compare, can make the 
necessary data available, and, if appropriate, can make arrangements 
and enter into agreements to share the needed information for inclusion 
on Physician Compare. We proposed that boards contact the Physician 
Compare support team at [email protected] to indicate 
interest and initiate the review and discussion process. Once decisions 
are made, they will be communicated via the CMS.gov Physician Compare 
initiative Web page and via the Physician Compare listserv. We 
requested comments on these proposals.
    The following is a summary of the public comments received on the 
``Board Certification'' proposals and our responses:
    Comment: Several commenters supported these proposals. A couple of 
commenters encouraged CMS to establish very clear criteria for what 
constitutes a suitable board for inclusion, in line with the criteria 
used by ABMS, which are reviewed and accepted through a multi-
stakeholder process. One commenter requested that CRNA board 
certification be posted on Physician Compare as well.
    Response: We understand that Web site users value this information, 
and we look forward to the opportunity to be able to include valid and 
reliable information in a timely manner. We proposed that, for purposes 
of CMS's selection, the board would need to demonstrate that it: Fills 
a gap in currently available board certification information listed on 
Physician Compare, can make the necessary data available, and, if 
appropriate, can make arrangements and enter into agreements to share 
the needed information for inclusion on Physician Compare. We also 
proposed that boards contact the Physician Compare support team at 
[email protected] to indicate interest and initiate the 
review and discussion process. We will provide more technical 
information on the finalized process and selection criteria, as well as 
any boards selected for inclusion, on the Physician Compare Initiative 
page on cms.gov. We also appreciate the suggestion to post board 
certification information for CRNAs on Physician Compare and encourage 
the relevant board(s) to contact the Physician Compare support team to 
initiate the process.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to add additional Board Certification 
information to the Physician Compare Web site. Specifically, we are 
finalizing our proposal to add ABWMS Board Certification information to 
Physician Compare. We are also finalizing our proposal to establish a 
process for reviewing interest from these boards as it is brought to 
our attention on a case-by-case basis, and selecting boards as possible 
sources of additional board certification information for Physician 
Compare. We are also finalizing our proposal that, for purposes of 
CMS's selection, the board would need to demonstrate that it: Fills a 
gap in currently available board certification information listed on 
Physician Compare, can make the necessary data available, and, if 
appropriate, can make

[[Page 53832]]

arrangements and enter into agreements to share the needed information 
for inclusion on Physician Compare. We are also finalizing our proposal 
that boards contact the Physician Compare support team at 
[email protected] to indicate interest and initiate the 
review and discussion process. Once decisions are made, they will be 
communicated via the CMS.gov Physician Compare initiative Web page and 
via the Physician Compare listserv.

D. Overview of the APM Incentive

1. Overview
    Section 1833(z) of the Act requires that an incentive payment be 
made to QPs for participation in Advanced APMs. In the CY 2017 Quality 
Payment Program final rule (81 FR 77399 through 77491), we finalized 
policies relating to the following topics:
     Beginning in 2019, if an eligible clinician participated 
sufficiently in an Advanced APM during the QP Performance Period, that 
eligible clinician may become a QP for the year. Eligible clinicians 
who are QPs are excluded from the MIPS reporting requirements for the 
performance year and payment adjustment for the payment year.
     For years from 2019 through 2024, QPs receive a lump sum 
incentive payment equal to 5 percent of their prior year's payments for 
Part B covered professional services. Beginning in 2026, QPs receive a 
higher update under the PFS for the year than non-QPs.
     For 2019 and 2020, eligible clinicians may become QPs only 
through participation in Advanced APMs.
     For 2021 and later, eligible clinicians may become QPs 
through a combination of participation in Advanced APMs and Other Payer 
Advanced APMs (which we refer to as the All-Payer Combination Option).
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
clarifications and modifications to some of the policies that we 
previously finalized and provided additional details and proposals 
regarding the All-Payer Combination Option (82 FR 30170-30207). In this 
CY 2018 Quality Payment Program final rule with comment period, we 
respond to public comments on those proposals and announce our final 
policies.
2. Terms and Definitions
    In the CY 2018 Quality Payment Program proposed rule, we explained 
that as we continue to develop the Quality Payment Program, we 
identified the need to propose additions, deletions, and changes to 
some of the definitions previously finalized in our regulations at 
Sec.  414.1305 (82 FR 30171).
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
to change the timeframe of the QP Performance Period under the All-
Payer Combination Option so that it would begin on January 1 and end on 
June 30 of the calendar year that is 2 years prior to the payment year. 
We proposed to add the definition of All-Payer QP Performance Period 
using this timeframe. We also proposed to add the definition of 
Medicare QP Performance Period, which would begin on January 1 and end 
on August 31 of the calendar year that is 2 years prior to the payment 
year. We would replace the single definition we established in the CY 
2017 Quality Payment Program final rule for QP Performance Period with 
the definitions of All-Payer QP Performance Period and Medicare QP 
Performance Period. To update the regulation to incorporate this 
proposal, we also proposed to remove ``QP Performance Period'' each 
time it occurs in our regulations and replace it with either ``All-
Payer QP Performance Period'' or ``Medicare QP Performance Period'' as 
relevant (82 FR 30171).
    We sought comment on these proposals. The following is a summary of 
the public comments received on these proposals and our responses:
    Comment: Three commenters supported our proposals to distinguish 
between the Medicare QP Performance Period and the All-Payer QP 
Performance Period in light of our proposal to make each last a 
different period of time.
    Response: We appreciate the commenters' support of these proposals.
    Final Action: We are not finalizing these proposals. As we discuss 
in section II.D.6.d.(3)(a) through (b) of this final rule with comment 
period, we are not finalizing our proposal to create a separate All-
Payer QP Performance Period. The QP Performance Period will begin on 
January 1 and end on August 31 of the calendar year that is 2 years 
prior to the payment year for both the Medicare Option and the All-
Payer Combination Option. Therefore, we will continue to use the term 
``QP Performance Period'' to refer to the performance period under both 
the Medicare Option and the All-Payer Combination Option, and the 
separate terms ``All-Payer QP Performance Period'' and ``Medicare QP 
Performance Period'' and the corresponding revisions to our regulations 
are no longer necessary.
    As we discussed in the CY 2018 Quality Payment Program proposed 
rule, in connection with our proposals to calculate Threshold Scores 
for QP determinations under the All-Payer Combination Option, we did 
not anticipate having or receiving information about attributed 
beneficiaries as we do under the Medicare Option. This is because under 
the All-Payer Combination Option, APM Entities or eligible clinicians 
would only submit aggregate payment and patient data. We would not have 
anything similar to a Participation List or an Affiliated Practitioner 
List for Other Payer Advanced APMs. Therefore, we proposed to change 
the definition of attributed beneficiary so that it only applies to 
Advanced APMs, not to Other Payer Advanced APMs (82 FR 30171).
    We sought comment on this proposal. The following is a summary of 
the public comments received on these proposals and our responses:
    Comment: One commenter supported our proposal.
    Response: We appreciate the commenter's support of our proposal.
    Comment: One commenter noted that this proposal is designed to 
facilitate making QP determinations at the individual eligible 
clinician level under the All-Payer Combination Option. The commenter 
suggested that not all Other Payer Advanced APMs will use attribution 
and also suggested that we create an alternate term to reflect Other 
Payer Advanced APMs where the beneficiary may or may not be attributed.
    Response: We appreciate the comment. Because we are collecting 
aggregate patient and payment data for the Other Payer Advanced APM 
part of QP determinations under the All-Payer Combination Option, we do 
not need to collect information about how an Other Payer Advanced APM 
establishes or conducts attribution.
    Final Action: After considering public comments, we are finalizing 
the policy as proposed at Sec.  414.1305 to modify the definition of 
attributed beneficiary so that it only applies to Advanced APMs.
    We sought comment on these terms, including how we have defined the 
terms, the relationship between terms, any additional terms that we 
should formally define to clarify the explanation and implementation of 
this program, and potential conflicts with other terms we use in 
similar contexts. We also sought comment on the naming of the terms and 
whether there are ways to name or describe their relationships to one 
another that make the definitions more distinct and easier to 
understand. For instance, we would consider options for a framework of 
definitions

[[Page 53833]]

that might more intuitively distinguish between APMs and Other Payer 
Advanced APMs and between APMs and Advanced APMs.
    The comments we received in response to this comment solicitation 
are discussed throughout this section as they are responsive to 
specific proposals regarding defined terms. We note that we may 
consider the creation of additional terms or revision of existing terms 
in future rulemaking.
3. Regulation Text Changes
a. Clarifications and Corrections
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
to revise the definition of APM Entity in the regulation at Sec.  
414.1305 to clarify that a ``payment arrangement with a non-Medicare 
payer'' is an other payer arrangement as defined in Sec.  414.1305. We 
proposed to make technical changes to the definition of Medicaid APM in 
Sec.  414.1305 to clarify that these arrangements must meet the Other 
Payer Advanced APM criteria set forth in Sec.  414.1420, and not just 
the criteria under Sec.  414.1420(a) as provided under the definition 
finalized in the CY 2017 Quality Payment Program final rule.
    To consolidate our regulations and avoid unnecessarily defining a 
term, we proposed to remove the defined term for Advanced APM Entity in 
Sec.  414.1305 and to replace ``Advanced APM Entity'' where it appears 
throughout the regulations with ``APM Entity.'' We also proposed to 
make this substitution in the definitions of Affiliated Practitioner 
and Attributed Beneficiary in Sec.  414.1305. Similarly, we proposed to 
replace ``Advanced APM Entity group'' with ``APM Entity group'' where 
it appears throughout our regulations. We noted that these proposed 
changes are technical and would not have a substantive effect on our 
policies.
    We sought comment on these proposals. The following is a summary of 
the public comments received on these proposals and our responses:
    Comment: A few commenters encouraged us not to delete the defined 
term ``Advanced APM Entity'' as proposed. Two of these commenters 
stated that if we delete the term ``Advanced APM Entity,'' we must 
revise the definition of APM Entity to explicitly include Advanced 
APMs.
    Response: We appreciate the comment. One of our goals in designing 
the Quality Payment Program is to minimize complexity and confusion. We 
believe that deleting the term Advanced APM Entity supports that goal. 
We do not believe that revising the definition of APM Entity is 
necessary. An APM Entity can participate in an APM that is, or is not, 
an Advanced APM.
    Comment: One commenter agreed that Medicaid APMs should be 
classified as Other Payer Advanced APMs, and one commenter supported 
our proposed technical changes generally.
    Response: We appreciate the commenter's support of our proposed 
technical changes in general. Regarding the proposed technical changes 
to the definition of Medicaid APM in Sec.  414.1305, we believe these 
changes clarify that these arrangements must meet the Other Payer 
Advanced APM criteria set forth in Sec.  414.1420, and not just the 
criteria under Sec.  414.1420(a).
    Final Action: After considering public comments, we are finalizing 
these technical changes as proposed.
    We proposed technical changes to correct the references in the 
first sentence of the regulation at Sec.  414.1415 to refer to the 
financial risk standard under paragraph (c)(1) or (2) and the nominal 
amount standard under paragraph (c)(3) or (4). Due to typographical 
errors, the regulation finalized in the CY 2017 Quality Payment Program 
final rule refers to paragraphs (d)(1) through (4), and there is no 
paragraph (d) in this section. We also proposed to correct 
typographical errors in Sec.  414.1420(a)(3)(i), (a)(3)(ii), (d) and 
(d)(1). In Sec.  414.1420(d), we proposed to correct the reference to 
the ``nominal risk standard'' to instead refer to the ``nominal amount 
standard.'' We proposed technical, non-substantive clarifications in 
Sec. Sec.  414.1425(a)(1) through (3), and (b)(2); and Sec.  
414.1435(d). We also proposed to correct a typographical error in Sec.  
414.1460(b) to refer to participation ``during a QP Performance 
Period'' instead of ``during the QP Performance Periods.''
    We sought comment on these proposals. We received no comments in 
response to these proposals.
    Final Action: We are finalizing these technical revisions to our 
regulations as proposed.
b. Changes to Sec.  414.1460
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
to reorganize and revise the monitoring and program integrity 
provisions at Sec.  414.1460. We proposed changes to paragraphs (a), 
(b), and (d) in this section of the proposed rule as these policies 
apply to both the Medicare Option and the All-Payer Combination Option. 
We explained that we addressed the changes we proposed to paragraphs 
(c) and (e) of Sec.  414.1460 in our discussion of the All-Payer 
Combination Option (82 FR 30195).
    We finalized in the CY 2017 Quality Payment Program final rule at 
Sec.  414.1460(d) that for any QPs who are terminated from an Advanced 
APM or found to be in violation of any Federal, State, or tribal 
statute, regulation, or binding guidance during the QP Performance 
Period or Incentive Payment Base Period or terminated after these 
periods as a result of a violation occurring during either period, we 
may rescind such eligible clinician's QP determinations and, if 
necessary, recoup part or all of any such eligible clinician's APM 
Incentive Payment or deduct such amount from future payments to such 
individuals. We also finalized that we may reopen and recoup any 
payments that were made in error (81 FR 77555).
    In the CY 2018 Quality Payment Program proposed rule, we 
acknowledged that rescinding QP determinations and reopening and 
recouping APM Incentive Payments are separate policies. For this 
reason, we proposed to reorganize Sec.  414.1460 so that paragraph (b) 
sets forth our policy on rescinding QP determinations and paragraph (d) 
sets forth our policy on reopening and recouping APM Incentive 
Payments. We proposed to revise Sec.  414.1460(b) to specify when we 
may rescind a QP determination. In addition, we proposed to remove the 
last sentence of Sec.  414.1460(d), which provides that an APM 
Incentive Payment would be recouped if an audit reveals a lack of 
support for attested statements provided by eligible clinicians and APM 
Entities. We explained that we believe that this provision is 
duplicative of the immediately preceding sentence, which permits us to 
reopen and recoup any erroneous payments in accordance with existing 
procedures set forth at Sec. Sec.  405.980 through 405.986 and 
Sec. Sec.  405.370 through 405.379. We proposed to codify our 
recoupment policy at Sec.  414.1460(d)(2), which provides that we may 
reopen, revise, and recoup an APM Incentive Payment that was made in 
error in accordance with procedures similar to those set forth at 
Sec. Sec.  405.980 through 405.986 and Sec. Sec.  405.370 through 
405.379 or as established under the relevant APM.
    In the CY 2017 Quality Payment Program final rule, we indicated at 
Sec.  414.1460(b) that we may reduce or deny an APM Incentive Payment 
to eligible clinicians who are terminated by APMs or whose APM Entities 
are terminated by APMs for non-compliance with Medicare conditions of 
participation or the terms of the relevant Advanced APMs in which they

[[Page 53834]]

participate during the QP Performance Period. We also finalized at 
Sec.  414.1460(a) that for QPs who we determines are not in compliance 
with all Medicare conditions of participation and the terms of the 
relevant Advanced APMs in which they participate during the QP 
Performance Period, there may be a reduction or denial of the APM 
Incentive Payment. In the CY 2018 Quality Payment Program proposed 
rule, we proposed to consolidate our policy on reducing and denying APM 
Incentive Payments and redesignate it to Sec.  414.1460(d)(1). Thus, we 
proposed to remove provisions regarding reducing and denying APM 
Incentive Payments from paragraphs (a) and (b) of Sec.  414.1460, and 
revise paragraph (d) to discuss when CMS may reduce or deny an APM 
Incentive Payment to an eligible clinician. We sought comment on these 
proposals.
    The following is a summary of the public comments received on these 
proposed changes to Sec.  414.1460 and our responses:
    Comment: Two commenters supported our proposals to revise the 
monitoring and program integrity provisions in order to separate 
rescinding QP determinations from recouping APM incentive payments and 
to consolidate APM incentive payment reduction and denial policies.
    Response: We appreciate the feedback and support for our proposals.
    Comment: One commenter suggested that we reconsider having an 
unlimited time to reopen, revise, and recoup Advanced APM payments 
``made in error.''
    Response: It appears that the commenter misunderstood the proposals 
we made in the CY 2018 Quality Payment Program proposed rule. We 
proposed that we may reopen, revise, and recoup an APM Incentive 
Payment that was made in error in accordance with procedures similar to 
those set forth at Sec. Sec.  405.980 through 405.986 and Sec. Sec.  
405.370 through 405.379 of this chapter or as established under the 
relevant APM. The procedures we referenced in the proposal apply 
broadly to providers and suppliers paid under Medicare Part A and B and 
impose reasonable time limits on reopenings and recoupments.
    Comment: One commenter sought clarification regarding the 
rescinding of a QP determination for a violation of ``any Federal, 
State, or tribal statute or regulation.'' This commenter was concerned 
that this provision is too broad and could be interpreted to include a 
violation of a law or regulation that has no impact on a QP 
determination or the provision of health care items and services. The 
commenter was especially concerned because no judicial or 
administrative review is available for a QP determination, and thus 
asserted that an eligible clinician could be determined not to be a QP 
for irrelevant reasons with no recourse to appeal. The commenter 
suggested that the regulation could instead say ``any relevant Federal, 
State, or tribal statute or regulation.''
    Response: We appreciate and agree with the commenter's concern. Our 
intent is to rescind QP determinations based on violations of Federal, 
State, or tribal statutes or regulations that are relevant to the 
Quality Payment Program, including our interest in maintaining the 
integrity of the Quality Payment Program. Therefore, we are modifying 
Sec.  414.1460(b)(3) so that we may rescind a QP determination if a QP 
is found to be in violation of the terms of the relevant Advanced APM 
or any relevant Federal, State, or tribal statute or regulation.
    Final Action: After considering public comments, we are finalizing 
our proposal to reorganize and revise Sec.  414.1460 with one 
modification. Specifically, we are finalizing with modification Sec.  
414.1460(b)(3) so that we may rescind a QP determination if a QP is 
found to be in violation of the terms of the relevant Advanced APM or 
any relevant Federal, State, or tribal statute or regulation.
4. Advanced APMs
a. Overview
    In the CY 2017 Quality Payment Program final rule, we finalized the 
criteria that define an Advanced APM based on the requirements set 
forth in sections 1833(z)(3)(C) and (D) of the Act (81 FR 77408). An 
Advanced APM is an APM that:
     Requires its participants to use certified EHR technology 
(CEHRT) (81 FR 77409-44414);
     Provides for payment for covered professional services 
based on quality measures comparable to measures under the quality 
performance category under MIPS (81 FR 77414-77418); and
     Either requires its participating APM Entities to bear 
financial risk for monetary losses that are in excess of a nominal 
amount, or the APM is a Medical Home Model expanded under section 
1115A(c) of the Act (81 FR 77418-77431). We refer to this criterion as 
the financial risk criterion.
b. Summary of Proposals
    We proposed the following changes and modifications to aspects of 
the financial risk criterion in the CY 2018 Quality Payment Program 
proposed rule:
     We proposed to amend Sec.  414.1415(c)(2) to exempt any 
APM Entities in Round 1 of the Comprehensive Primary Care Plus (CPC+) 
Model as of January 1, 2017 from the requirement that, beginning in the 
2018 QP Performance Period, the Medical Home Model financial risk 
standard applies only to an APM Entity that is participating in a 
Medical Home Model if it has fewer than 50 eligible clinicians in its 
parent organization (82 FR 30172-30173).
     We proposed to amend Sec.  414.1415(c)(3)(i)(A) and 
(c)(4)(i)(A) through (D) to more clearly define the generally 
applicable revenue-based nominal amount standard and the Medical Home 
Model revenue-based nominal amount standard as a percentage of the 
average estimated total Medicare Parts A and B revenue of all providers 
and suppliers in participating APM Entities (82 FR 30173).
     We proposed to amend Sec.  414.1415(c)(3)(i)(A) to state 
that the generally applicable revenue-based nominal amount standard 
remains at 8 percent of the average estimated total Medicare Parts A 
and B revenue of providers and suppliers in participating APM Entities 
for the 2019 and 2020 QP Performance Periods, and to address the 
standard for QP Performance Periods after 2020 through subsequent 
rulemaking (82 FR 30173-30174).
     We proposed to amend Sec.  414.1415(c)(4)(i)(A) through 
(D) to provide that, to be an Advanced APM, a Medical Home Model must 
require that the total annual amount that an APM Entity potentially 
owes us or foregoes under the Medical Home Model be at least the 
following amounts:
    ++ For QP Performance Period 2018, 2 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
    ++ For QP Performance Period 2019, 3 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
    ++ For QP Performance Period 2020, 4 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
    ++ For QP Performance Periods 2021 and later, 5 percent of the 
average estimated total Medicare Parts A and B revenue of all providers 
and suppliers in participating APM Entities (82 FR 30174).

[[Page 53835]]

c. Bearing Financial Risk for Monetary Losses
(1) Medical Home Model Eligible Clinician Limit
    In the CY 2017 Quality Payment Program final rule, we finalized 
that beginning in the 2018 QP Performance Period, the Medical Home 
Model financial risk and nominal amount standards would only apply to 
APM Entities that participate in Medical Home Models and that have 
fewer than 50 eligible clinicians in the organization through which the 
APM Entity is owned and operated (81 FR 77430). We refer to this policy 
throughout this final rule with comment period as the 50 eligible 
clinician limit. Under this policy, the Medical Home Model financial 
risk and nominal amount standards would be applicable only for those 
APM Entities owned and operated by organizations with fewer than 50 
eligible clinicians. We note this policy does not apply to Medical Home 
Models expanded under section 1115A of the Act.
    In the CY 2018 Quality Payment Program proposed rule, we stated 
that we finalized the 50 eligible clinician limit after practices 
applied and signed agreements with CMS to participate in Round 1 of the 
CPC+ Model. As such, practices applying to participate in Round 1 of 
the CPC+ Model were not necessarily aware of the eligible clinician 
limit policy and, by the beginning of 2018, will have already 
participated in the CPC+ Model for one year without this requirement 
applying to them. Thus, to permit continued and uninterrupted testing 
of the CPC+ Model in existing regions, we stated that we believe it is 
necessary to exempt practices participating in Round 1 of the CPC+ 
Model from this requirement. Additionally, we noted that because in the 
future all APM Entities would know about this requirement prior to 
their enrollment, and in order to ensure that large APM Entities that 
are able to bear more risk enroll in models with higher levels of risk, 
we proposed that CPC+ Model participants who enroll in the future (for 
example, in Round 2 of the CPC+ Model) would not be exempt from this 
requirement (82 FR 30172-30173).
    Therefore, we proposed to amend Sec.  414.1415(c)(2) to exempt any 
APM Entity participating in Round 1 of the CPC+ Model from the 
requirement that beginning in the 2018 QP Performance Period, the 
Medical Home Model financial risk standard applies only to an APM 
Entity that is participating in a Medical Home Model if it has fewer 
than 50 eligible clinicians in its parent organization. We sought 
comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Several commenters supported our proposal.
    Response: We thank commenters for their support our proposal.
    Comment: The majority of commenters on this issue supported CMS's 
proposal to exempt participants in Round 1 of the CPC+ Model from the 
50 eligible clinician limit, but also requested that we go further. 
Some commenters stated that all CPC+ Model participants should be 
exempted from the 50 eligible clinician limit and stated that applying 
the 50 eligible clinician limit to other CPC+ Model participants would 
discourage them from participating or continuing to participate in the 
CPC+ Model. Some of these commenters were concerned that future rounds 
of CPC+ Model participants would likely not become QPs, but they would 
instead be subject to MIPS under the APM scoring standard because they 
would not meet the generally applicable financial risk and nominal 
amount standards for an Advanced APM through participation in the CPC+ 
Model. A few commenters suggested that CMS exempt risk-bearing State 
models that would be Medical Home Models from the 50 eligible clinician 
limit. These commenters suggested that CMS apply this exemption in the 
same way as for Round 1 of the CPC+ Model and stated that the 50 
eligible clinician limit could deter participation in, and negatively 
impact the overall efficacy of such models.
    Many commenters requested that CMS remove the 50 eligible clinician 
limit for all Medical Home Models, not just exempt those practices in 
Round 1 of the CPC+ Model. These commenters suggested that the 50 
eligible clinician limit is arbitrary and expressed concern that it may 
exclude clinicians and practices who could benefit most from the 
Medical Home Model financial risk and nominal amount standards. Some of 
these commenters also expressed concern that the 50 eligible clinician 
limit could discourage larger group or multispecialty practices from 
participating in in Medical Home Models, which could limit access for 
beneficiaries to primary care medical home services. The commenters 
noted that many health care providers associated with large group or 
multispecialty practices are well positioned to deliver primary care 
medical home services, but they might be discouraged from participating 
because they would exceed the 50 eligible clinician limit. Some of the 
commenters who opposed applying the 50 eligible clinician limit to any 
Medical Home Model expressed concern that the limit could distort 
market dynamics and have unintended consequences. These commenters also 
suggested the 50 eligible clinician limit reflects a preference for 
larger practices to participate in ACOs instead of Medical Home Models, 
which the commenters disagreed with.
    Response: We established the 50 eligible clinician limit because we 
believe larger group practices, and particularly those that are a part 
of larger parent organizations, have the capacity to assume levels of 
risk that meet the generally applicable financial risk and nominal 
amount standards. We appreciate the commenters' concerns, but we 
believe that the 50 eligible clinician limit is a reasonable way to 
distinguish larger organizations more capable of bearing risk from 
smaller organizations for which the generally applicable financial risk 
and nominal amount standards would represent a substantial, genuine 
barrier to participation in Advanced APMs.
    As we discussed in the CY 2017 Quality Payment Program final rule, 
the 50 eligible clinician limit was intended to encourage larger 
organizations to move into Advanced APMs with greater levels of risk. 
We did not intend to imply that participation in Medical Home Models is 
necessarily inappropriate for larger organizations; and we recognize 
that Medical Home Models differ from other APMs, such as ACO 
initiatives, in that Medical Home Models focus on improving primary 
care through much more targeted interventions than those commonly found 
in other APMs. We encourage organizations that can effectively 
participate in Medical Home Models to do so, regardless of whether that 
participation results in the participating eligible clinicians in the 
APM Entity becoming QPs in a given year (81 FR 77429). However, we 
believe it is appropriate for larger organizations that exceed the 50 
eligible clinician limit to assume risk that meets the generally 
applicable financial risk and nominal amount standards, commensurate 
with their capability, in order for their participation in a Medical 
Home Model to be treated as participation in an Advanced APM for 
purposes of QP determinations.
    Comment: Some commenters suggested alternative approaches to 
limiting the application of the Medical Home Model financial risk and 
nominal amount standards such as applying the 50 eligible clinician 
limit at the APM Entity level, using patient panel size

[[Page 53836]]

attributed to the APM Entity, or applying the Medical Home Model 
financial risk and nominal amount standards based on each APM Entity's 
demonstrated ability to assume financial risk.
    Response: We appreciate the commenters' suggestions. We disagree 
that it would be appropriate to apply the 50 eligible clinician limit 
to the number of eligible clinicians in the APM Entity. We believe an 
organization's ability to bear risk is more likely to be correlated 
with its overall size in terms of eligible clinicians in the entire 
organization, rather than with the number of eligible clinicians that 
participate in a given APM Entity. Establishing the limit based on the 
size of the APM Entity could also incentivize APM Entities to 
artificially limit the number of clinicians who participate in each APM 
Entity. We believe that using patient panel size would share some of 
the drawbacks associated with basing the limit on APM Entity size, and 
would also add considerable variability and complexity to the 
implementation of the Medical Home Model standard. Lastly, we do not 
have any standardized or consistent way of assessing individual APM 
Entities' ability to assume financial risk, thus we do not believe that 
implementing such a standard would be feasible.
    Comment: One commenter expressed concern that it is operationally 
difficult to identify the parent organization of a billing entity and 
even more so to decipher the relationships between multiple parent and 
subsidiary entities. This commenter also noted that the application of 
different financial risk and nominal amount standards for organizations 
of different sizes would require complex rules governing how the APM 
entities are treated after acquisition by, merger with, or separation 
from, another organization with 50 or more eligible clinicians. This 
commenter also urged CMS to recognize that many medium size 
organizations may fluctuate in their size at or near the 50 eligible 
clinician limit, potentially deterring these organizations from 
participating in a Medical Home Model.
    Response: We agree that it may be operationally difficult to 
identify the parent organizations of APM Entities, as well as the 
relationships to, and between, multiple subsidiary entities. That said, 
we believe that we will be able to do so. We intend to rely primarily 
on information submitted by the APM Entities themselves, who should be 
most familiar with their own corporate structures, to implement this 
policy.
    Final Action: After considering public comments, we are finalizing 
our proposal to exempt any entities in Round 1 of the CPC+ Model as of 
January 1, 2017 from the requirement that, beginning in the 2018 QP 
Performance Period, the Medical Home Model financial risk standard 
applies only to an APM Entity that is participating in a Medical Home 
Model if it has fewer than 50 eligible clinicians in its parent 
organization by amending Sec.  414.1415(c)(2) and adding Sec.  
414.1415(c)(7).
    We are also making accompanying edits to our discussion of the 50 
eligible clinician limit for Medicaid Medical Home Models by amending 
Sec. Sec.  414.1420(d)(2) and Sec.  414.1415(d)(4) and adding Sec.  
414.1420(d)(8).
(2) Nominal Amount of Risk
(a) Generally Applicable Revenue-Based Nominal Amount Standard
    In the CY 2017 Quality Payment Program final rule, we finalized two 
generally applicable standards for defining what is a nominal amount of 
risk--a benchmark-based standard and a revenue-based standard. We also 
finalized an alternative nominal amount standard applicable only to 
Medical Home Models. Both the generally applicable revenue-based 
nominal amount standard and the Medical Home Model revenue-based 
nominal amount standards state the standard in terms of average 
estimated total Medicare Parts A and B revenue of participating APM 
Entities (81 FR 77424).
    In the CY 2018 Quality Payment Program proposed rule, we 
acknowledged that this language may be ambiguous as to whether it is 
intended to include payments to all providers and suppliers in an APM 
Entity or only payments directly to the APM Entity itself. To eliminate 
this potential ambiguity, we proposed to amend Sec. Sec.  
414.1415(c)(3)(i)(A) and (c)(4)(i)(A) through (D) to more clearly 
define the generally applicable revenue-based nominal amount standard 
and the Medical Home Model revenue-based nominal amount standard as a 
percentage of the average estimated total Medicare Parts A and B 
revenue of providers and suppliers in participating APM Entities. Under 
the proposed policy, when assessing whether an APM meets the generally 
applicable revenue-based nominal amount standard, where total risk 
under the model is not expressly defined in terms of revenue, we would 
calculate the estimated total Medicare Parts A and B revenue of 
providers and suppliers that are at risk for each APM Entity. We would 
then calculate an average of all the estimated total Medicare Parts A 
and B revenue of providers and suppliers that are at risk for each APM 
Entity, and if that average estimated total Medicare Part A and B 
revenue that is at risk for all APM Entities was equal to or greater 
than 8 percent, the APM would satisfy the generally applicable revenue-
based nominal amount standard (82 FR 30173). The same approach would be 
taken for assessing whether a Medical Home Model meets the Medical Home 
Model nominal amount standard.
    We requested comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Two commenters supported CMS's proposal. One commenter 
stated that it would be easier for eligible clinicians and practices to 
understand.
    Response: We appreciate the commenter's support of our proposal.
    Comment: Several commenters suggested that the revenue-based 
nominal amount standards should be based on the revenues of the 
individual APM Entities participating in the APM that would responsible 
for repayment of any losses. These commenters expressed concern with 
CMS's proposal, assuming that the risk for smaller APM Entities to 
participate in the APM would effectively be higher than 8 percent if 
there was also participation by large APM entities. These commenters 
stated that if the calculation was made at the individual APM entity 
level, smaller APM entities would be protected from being at risk for 
more than 8 percent of their revenues. These commenters stated that 
CMS's proposal would create barriers to Advanced APM participation for 
smaller APM Entities and cause such APM entities to not participate in 
Advanced APMs, eventually only allowing for larger APM Entities capable 
of bearing such risk to participate. Several commenters suggested that 
the proposed clarification would lead to a lack of predictability in 
terms of financial risk that could disadvantage smaller APM Entities, 
as participants would not know whether an APM met the risk standard or 
what the risk to any individual APM Entity would be until after the end 
of each year, when all of the participating entities and their revenues 
were known.
    Response: We disagree that our proposal to clarify the way we 
evaluate the generally applicable nominal amount standard would 
disadvantage smaller APM Entities. We emphasize that we make Advanced 
APM determinations at the APM level. The inquiry we make is whether the 
APM itself requires participating APM

[[Page 53837]]

Entities to bear risk that meets the relevant risk standard. It appears 
that the commenter may not have understood that only APMs, and not APM 
Entities, can be Advanced APMs as defined in our regulations. As such, 
we would calculate the average estimated total Medicare Parts A and B 
revenue of providers and suppliers in APM Entities that are 
participating in an APM, which pertains to an entire APM, not to 
individual APM Entities. The Advanced APM determination that is based 
in part on this calculation would apply to all APM Entities 
participating in that APM (except in the case of an APM Entity that 
exceeds the 50 eligible clinician limit and participates in a Medical 
Home Model). In particular, large APM Entities would not be treated any 
differently than smaller APM Entities, as their individual revenues 
would have no impact on their QP status. We also disagree that our 
proposed clarification would introduce unpredictability, as we would 
make this calculation prior to the relevant performance period of the 
APM.
    We also note that, for APMs that expressly limit total risk in 
terms of revenue, we do not assess whether an APM meets the generally 
applicable revenue-based nominal amount standard based on the 
percentage of average estimated total Medicare Parts A and B revenue of 
providers and suppliers in participating APM Entities. For example, the 
Medicare ACO Track 1+ Model expressly caps risk for certain ACOs in 
terms of participant revenue). For these APMs, if the amount of total 
risk, in terms of revenue, required under the terms of the APM is equal 
to or greater than 8 percent, then the APM would meet the revenue-based 
nominal amount standard.
    Comment: Several commenters suggested that CMS modify the revenue-
based nominal amount standards to exclude Part A revenues as many APMs 
do not include hospitals and therefore, should not accept risk for Part 
A revenues. These commenters suggested that including Part A revenues 
in the risk calculation encourages health care providers, including 
eligible clinicians, to not partner with hospitals in an APM and may 
further fragment markets by discouraging collaboration between 
hospitals, physician groups, and other health care providers, in turn 
making participation in risk bearing models more difficult. These 
commenters also expressed concern that the proposed clarification would 
discriminate against physician practices and health systems that are 
owned or affiliated with hospitals, because they would have no choice 
but to include Part A revenues, essentially requiring the assumption of 
more risk by these entities. These commenters suggested that CMS 
finalize a revenue-based nominal amount standard that only includes 
Part B revenues.
    Response: We reiterate that we did not propose to make changes to 
the types of revenue are included in the generally applicable revenue-
based nominal amount standard. Rather, we proposed to clarify that we 
would include revenues of all providers and suppliers in an APM Entity 
(as opposed to only the revenues of the APM Entity itself.) We disagree 
that the generally applicable revenue-based nominal amount standard 
should only include Part B revenues, as many APM Entities participating 
in current Advanced APMs include hospitals and other types of 
institutional providers or suppliers that may receive both Part A and B 
revenues and APM Entities that could potentially participate in future 
Advanced APMs may also receive both Part A and B revenues. We note that 
the generally applicable revenue-based nominal amount standard is 
inclusive only of the Medicare Part A and B revenues of providers and 
suppliers in participating APM Entities; therefore, if the providers 
and suppliers in a given APM Entity have only Medicare Part B revenues, 
only such revenues will be considered.
    We also disagree that including Part A revenues would discourage 
collaboration between physicians and hospitals. While APM Entities that 
include both physicians and hospitals may, depending on an individual 
APM's design, be exposed to greater risk, they would also presumably 
have greater capacity to assume this risk and may also have greater 
capacity to manage their beneficiaries across the spectrum of care.
    Comment: Several commenters expressed confusion regarding CMS's 
proposed clarification and requested that CMS provide additional 
clarity on what CMS intends to calculate as the average estimated 
revenues of the participants in the APM entity when making a 
determination as to whether an APM meets the financial risk criterion. 
Many of these commenters believe that the generally applicable revenue-
based nominal amount standard meant that an individual APM Entity's 
losses could be limited to 8 percent of that individual entity's 
revenues. As such, many of these commenters suggested that CMS modify 
the regulation to clearly state that APM Entities meet the nominal risk 
standard if the total amount that each individual APM Entity 
potentially owes CMS or foregoes under an APM is equal to 8 percent of 
the estimated average total Medicare Part A and B revenues.
    Response: We reiterate that the financial risk criterion is applied 
for the purpose of making Advanced APM determinations with respect to 
an APM as a whole, and as such, is assessed at the APM level. 
Specifically, an APM meets the generally applicable revenue-based 
nominal amount standard either because the design of the APM mandates 
that participating APM Entities assume total risk of at least 8 percent 
of Medicare Parts A and B revenues, or because we calculate that under 
the terms of the APM the average estimated amount of total risk, across 
all participating APM Entities, is greater than 8 percent of the 
estimated average total Part A and B revenues. We further clarify that 
the generally applicable revenue-based nominal amount standard does not 
limit or cap an individual APM Entity's losses at 8 percent of that 
individual APM Entity's revenues, but rather represents a minimum 
amount of risk the average participating APM Entity must be exposed to 
in order for the APM to be an Advanced APM. The total amount of risk an 
individual APM Entity is exposed to may be higher than 8 percent of the 
total combined Medicare Part A and B revenues for the eligible 
clinicians and any other providers and suppliers that make up the APM 
Entity.
    Comment: Many commenters suggested that CMS expand the definition 
of financial risk to include the investment and business risk assumed 
by providers and suppliers who comprise APM Entities that participate 
in APMs. These commenters disagreed with CMS's contention in the CY 
2017 Quality Payment Program final rule that CMS could not accurately 
assess business risk without exceptional administrative burden on both 
the agency and APM Entities in order to quantify and verify such 
expenditures. These commenters stated that CMS could design standards 
for business risk and required documentation and attestation from APM 
Entities. These commenters also disagreed with CMS's statements in the 
CY 2017 Quality Payment Program final rule that investment and business 
risk are not analogous to performance risk.
    Response: We recognize the substantial investments that many APM 
Entities make in order to become successful APM participants. 
Nonetheless, as we discussed in the CY 2017 Quality Payment Program 
final rule, we continue to believe that there would be significant 
complexity involved in creating an objective and

[[Page 53838]]

enforceable standard for determining whether an entity's business risk 
exceeds a nominal amount, and that the statutory framework for the APM 
Incentive Payment recognizes that not all alternative payment 
arrangements will meet the criteria to be considered for purposes of 
the QP determination. We also reiterate that business risk is generally 
a cost that is unrelated to performance-based payment under an APM. No 
matter how well or poorly an APM Entity performs, those costs are not 
reduced or increased correspondingly. Therefore, we maintain the 
position that business risk is not analogous to performance risk in the 
APM context because those activities and investments are costs that are 
not incorporated into the financial calculations of an APM (81 FR 
77420).
    Final Action: After considering public comments, we are finalizing 
amendments to Sec. Sec.  414.1415(c)(3)(i)(A) and (c)(4)(i)(A) through 
(E) to clarify that the revenue-based nominal amount standards are 
based on a percentage of the average estimated total Medicare Part A 
and B revenue of providers and suppliers in the participating APM 
Entities.
    In the CY 2017 Quality Payment Program final rule, we finalized the 
amount of the generally applicable revenue-based nominal amount 
standard at 8 percent for the first two QP Performance Periods only, 
and we sought comment on what the revenue-based nominal amount standard 
should be for the third and subsequent QP Performance Periods. 
Specifically, we sought comment on: (1) setting the revenue-based 
standard for 2019 and later at up to 15 percent of revenue; or (2) 
setting the revenue-based standard at 10 percent so long as risk is at 
least equal to 1.5 percent of expected expenditures for which an APM 
Entity is responsible under an APM (81 FR 77427).
    After considering public comments submitted on the potential 
options for increasing the generally applicable revenue-based nominal 
amount standard for 2019 QP Performance Period and later, in the CY 
2018 Quality Payment Program proposed rule, we proposed to maintain the 
current generally applicable revenue-based nominal amount standard at 8 
percent of the average estimated total Medicare Part A and B revenue of 
all providers and suppliers in participating APM Entities for the 2019 
and 2020 QP Performance Periods, and to address the standard for QP 
Performance Periods after 2020 through subsequent rulemaking (82 FR 
30173).
    We sought comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Many commenters supported CMS's proposal. Some of these 
commenters suggested that CMS maintain the 8 percent generally 
applicable revenue-based nominal amount standard for the 2021 QP 
Performance Period and later. Several commenters also suggested that 
until CMS can determine how the current generally applicable revenue-
based nominal amount standard affects APM Entities and eligible 
clinicians, CMS should not consider increases or decreases in the 
generally applicable revenue-based nominal amount standard.
    Response: We appreciate commenters' support of our proposal. We 
agree that additional time is needed for us to assess how the current 
generally applicable revenue-based nominal amount standard is affecting 
participation in Advanced APMs before we propose to change the 
generally applicable revenue-based nominal amount standard.
    Comment: Many commenters suggested that CMS not increase the 
generally applicable revenue-based nominal amount standard beyond 8 
percent. Some commenters suggested that CMS reduce the amount of 
revenue-based financial risk an APM Entity must bear under the terms of 
an APM to meet the requirements for an APM to qualify as an Advanced 
APM. Some of these commenters also recommended that we phase in the 
revenue-based nominal amount standard at 4 percent for the 2018 QP 
Performance Period, 6 percent for the 2019 and 2020 QP Performance 
Periods, and 8 percent beginning for the 2021 QP Performance Period and 
beyond. These commenters suggested that APM Entities in Advanced APMs 
will be facing de facto higher levels of risk as QP payment amount and 
patient count thresholds increase in future years, and stated that 8 
percent represents a level or risk that is already more than nominal.
    One commenter stated that in the CY 2017 Quality Payment Program 
final rule, CMS used discretionary authority to establish a different 
Medical Home Model financial risk standard and lower level of risk in 
the Medical Home Model nominal amount standard. This commenter 
suggested that CMS use the same discretionary authority to establish a 
more gradual progression of financial risk for Advanced APMs in 
general.
    Response: We continue to believe that 8 percent of Medicare Part A 
and B revenues generally represents an appropriate standard for more 
than nominal financial risk. We established a gradual progression of 
financial risk within the Medical Home Model nominal amount standard in 
recognition of the fact that few APM Entities in Medical Home Models 
have had experience assuming financial risk and because the MACRA 
statute specifically makes medical homes an instrumental piece of the 
law (81 FR 77403). We believe that most APM Entities in Advanced APMs 
that are not Medical Home Models generally have some previous 
experience in assuming financial risk.
    We also note that establishing a more gradual progression of 
financial risk required for purposes of deciding whether an APM to be 
considered is an Advanced APM would not reduce the level of risk under 
any particular APM, nor would it likely change the list of Advanced 
APMs in 2018.
    Final Action: After considering public comments, we are finalizing 
our proposal to maintain the current revenue-based nominal amount 
standard at 8 percent of the average estimated total Medicare Parts A 
and B revenue of all providers and suppliers in participating APM 
Entities for the 2019 and 2020 QP Performance Periods at Sec.  
414.1415(c)(3)(i)(A). We will address the standard for QP Performance 
Periods after 2020 in future rulemaking.
    We also sought comment on whether we should consider either a lower 
or higher revenue-based nominal amount standard for the 2019 and 2020 
QP Performance Periods, and we sought comment on the amount and 
structure of the revenue-based nominal amount standard for QP 
Performance Periods 2021 and later. In particular, we sought comment on 
whether we should consider a different, potentially lower, revenue-
based nominal amount standard only for small practices and those in 
rural areas (82 FR 30173-30174).
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: Many commenters supported CMS establishing a lower nominal 
amount standard for small and rural practices participating in Advanced 
APMs. Some of these commenters stated that a lower revenue-based 
nominal amount standard for small practices and those in rural areas 
should apply to both practices that are separate participants in 
Advanced APMs as well as those that join larger APM Entities to 
participate in Advanced APMs. Several commenters suggested that CMS 
extend the Medical Home

[[Page 53839]]

Nominal financial risk and nominal amount standards to small and rural 
practices participating in all Advanced APMs. These commenters also 
suggested that CMS use the same definitions for small and rural 
practices currently used for MIPS. A few commenters did not support the 
notion of creating a lower revenue-based nominal amount standard for 
small or rural practices. These commenters suggested the CMS avoid 
creating unnecessary distinctions in the application of the generally 
applicable revenue-based nominal amount standard. These commenters 
noted that establishing a lower revenue-based nominal amount standard 
for small or rural practices creates an unnecessary division and 
possibly competition where affected practices may terminate their 
participation in an ACO or other APM Entity to benefit from lower risk 
thresholds available to them on their own, creating division among 
providers based on practice size and geography. These commenters also 
urged CMS to explore alternative methods to address the issue of 
resource adequacy rather than just lowering the nominal amount 
standards for small and rural practices.
    Response: We appreciate this feedback from commenters. We may 
address the topic of a different, potentially lower revenue-based 
nominal amount standard for small or rural practices in future 
rulemaking. We welcome further public comment on this issue.
    Final Action: We are not taking any action at this time.
(b) Medical Home Model Nominal Amount Standard
    In the CY 2017 Quality Payment Program final rule, we finalized 
that for a Medical Home Model to be an Advanced APM, the total annual 
amount that an APM Entity potentially owes CMS or foregoes must be at 
least:
     For QP Performance Period 2017, 2.5 percent of the 
estimated average total Medicare Parts A and B revenues of 
participating APM entities.
     For QP Performance Period 2018, 3 percent of the estimated 
average total Medicare Parts A and B revenues of participating APM 
entities.
     For QP Performance Period 2019, 4 percent of the estimated 
average total Medicare Parts A and B revenues of participating APM 
entities.
     For QP Performance Period 2020 and later, 5 percent of the 
estimated average total Medicare Parts A and B revenues of 
participating APM entities (81 FR 77428).
    In the CY 2018 Quality Payment Program proposed rule, we 
reconsidered this schedule for incremental annual increases in the 
nominal amount standard that we finalized for Medical Home Models. We 
acknowledged that establishing an even more gradual increase in risk 
for Medical Home Models with a lower risk floor for the 2018 QP 
Performance Period may be better suited to the circumstances of many 
APM Entities in Medical Home Models that have little experience with 
risk. We also reiterated, as we noted for the generally applicable 
nominal amount standard, that the terms and conditions in the 
particular APM govern the actual risk that participants experience; the 
nominal amount standard merely sets a floor on the level of risk 
required for the APM to be considered an Advanced APM. To that end, we 
noted that we believe a small reduction of risk in the Medical Home 
Model nominal amount standard beginning in the 2018 QP Performance 
Period, along with a more gradual progression toward a 5 percent 
nominal amount standard, would allow for greater flexibility at the APM 
level in setting financial risk thresholds that would encourage more 
participation in Medical Home Models and be more sustainable for the 
type of APM Entities that would potentially participate in Medical Home 
Models (82 FR 30174).
    Therefore, we proposed that to be an Advanced APM, a Medical Home 
Model must require that the total annual amount that an APM Entity 
potentially owes CMS or foregoes under the Medical Home Model be at 
least the following:
     For QP Performance Period 2018, 2 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
     For QP Performance Period 2019, 3 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
     For QP Performance Period 2020, 4 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
     For QP Performance Periods 2021 and later, 5 percent of 
the average estimated total Medicare Parts A and B revenue of all 
providers and suppliers in participating APM Entities.
    We sought comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Many commenters expressed support for a more gradual 
increase in the Medical Home Model nominal amount standard. Some of 
these commenters also noted that a more gradual increase would enable 
greater flexibility in setting financial risk thresholds, encourage 
greater participation in Medical Home Models, reinforcing the overall 
sustainability of Medical Home Models.
    Response: We appreciate these commenters' support of this proposal. 
We agree that the proposed change to a more gradual increase in the 
Medical Home Model nominal amount standard will allow for greater 
participation in current and future Medical Home Models.
    Comment: Some commenters, while supporting the proposal, expressed 
concern that increasing the standard to 5 percent of average estimated 
total Medicare Parts A and B revenue by 2021 might represent too much 
risk for Medical Home Model participants. These commenters cited the 
upfront costs of establishing the infrastructure required to deliver 
services within Medical Home Models and the limited ability of most 
primary care practices to take on any downside risk as reasons to cap 
the Medical Home Model nominal amount standard at 2 or 2.5 percent and 
maintain the standard at that level until it is determined that a 
sufficient number participants in Medical Home Models have demonstrated 
the ability to succeed.
    Response: We do not agree that increasing the standard to 5 percent 
of average estimated total Medicare Parts A and B revenue by 2021 
represents too much risk for Medical Home Model participants. As we 
stated in the CY 2017 Quality Payment Program final rule, we continue 
to believe that setting the standard at 5 percent of Parts A and B 
revenue strikes the appropriate balance to reflect the meaning of 
``nominal'' in the Medical Home Model context (81 FR 77428).
    Comment: Several commenters disagreed with the proposed change to 
the Medical Home Model nominal amount standard and to the Medical Home 
Model nominal amount standard more generally. These commenters 
expressed concern that CMS has not complied with Congressional intent 
that Medical Home Models should be able to qualify as Advanced APMs 
without being required to bear more than nominal risk. Some of these 
commenters suggested it would be more appropriate for primary care 
clinicians in Medical Home Models to accept investment or business 
risk, and not financial risk, arguing that investment or business risk 
reflects Congressional intent regarding the qualification of Medical 
Home Models as Advanced APMs. One commenter strongly recommended that

[[Page 53840]]

CMS remove the Medical Home Model standard in its entirety and stated 
that medical homes should not be subject to any financial risk.
    Response: We disagree with these commenters, and we believe that 
the Medical Home Model financial risk and nominal amount standard is 
reflective of Congressional intent as expressed in section 
1833(z)(3)(D) of the Act. We continue to believe that the application 
of this standard is appropriate for Medical Home Models, especially 
since the statute expressly calls out medical homes for special 
consideration in certain situations. We believe it is appropriate to 
exercise our discretion to separately set financial risk and nominal 
amount standards for Medical Home Models that are below an amount we 
consider to be a ``more than nominal'' amount in the context of other 
types of APMs (81 FR 77427). The generally applicable and Medical Home 
Model financial risk and nominal amount standards represent our 
interpretation of the statutory requirement for Advanced APMs to bear 
more than a nominal amount of financial risk, and we believe those 
standards, including the modifications we proposed to the Medical Home 
Model nominal amount standard, are appropriate for the QP Performance 
Periods in which they apply.
    We also reiterate that, as described in the CY 2017 Quality Payment 
Program final rule, a Medical Home Model that has been expanded under 
section 1115A(c) of the Act would meet the expanded Medical Home Model 
criterion under section 1833(z)(3)(D)(ii)(II) of the Act, and thus 
would not need to meet the financial risk criterion under section 
1833(z)(3)(D)(ii)(I) of the Act in order to be an Advanced APM. Under 
this policy, an APM would have to be both determined to be a Medical 
Home Model and in fact be expanded using the authority under section 
1115A(c) of the Act in order to be an Advanced APM without considering 
the financial risk and nominal amount standards (81 FR 77431).
    Lastly, we disagree with commenters that costs not encompassed by 
an APM's financial risk arrangements should be considered when 
assessing financial risk under the APM. For a more extensive discussion 
of this issue, we refer readers to the CY 2017 Quality Payment Program 
final rule (81 FR 77420; 81 FR 77467).
    Comment: One commenter expressed concern that CMS's proposed change 
to the Medical Home Model nominal amount standard further reduces the 
risk required for Medical Home Models to qualify as Advanced APMs, 
which is substantially lower than the risk required to participate as 
an ACO in other Advanced APMs. The commenter expressed that the 
difference in nominal amount standards creates a disparity that may 
lead health care providers to join a Medical Home Model over an ACO 
model because of the lower risk thresholds.
    Response: We thank this commenter for their feedback. While we 
understand the concern that the separate Medical Home Model financial 
risk and nominal amount standards set a lower bar to be an Advanced APM 
than the generally applicable financial risk and nominal amount 
standards, in most cases we do not believe that this difference will 
encourage providers or practices to join Medical Home Models rather 
than Advanced APMs that have ACOs as the APM Entities or other types of 
Advanced APMs. We note that an APM only qualifies as a Medical Home 
Model if it meets the criteria specified in the definition at Sec.  
414.1305, including that it has a primary care focus with participants 
that primarily include primary care practices or multispecialty 
practices that include primary care physicians and practitioners and 
offer primary care services. Therefore, participation in Medical Home 
Models is generally unavailable to eligible clinicians who in APM 
Entities that do not principally provide primary care services.
    In addition, many APMs that have ACOs as the APM Entities use 
beneficiary attribution or alignment methodologies that rely on 
determining where a beneficiary received the plurality of evaluation 
and management services, which are often furnished by primary care 
practitioners. This creates an incentive for larger organizations such 
as health systems and multi-specialty group practices that join to form 
ACOs to include primary care providers in the ACO in order to maintain 
adequate patient attribution.
    Final Action: After considering public comments, we are finalizing 
our proposal with one modification. Upon further consideration, we do 
not believe it would be appropriate to lower the Medical Home Model 
nominal amount standard to 2 percent for the 2018 QP Performance Period 
after the standard has been set at 2.5 percent for the 2017 QP 
Performance Period. Instead, we believe it would be more judicious to 
maintain the Medical Home Model nominal amount standard at 2.5 percent 
for the 2018 QP Performance Period as well. We believe finalizing this 
level of risk for the 2018 QP Performance Period is consistent with our 
goal of establishing an even more gradual increase in risk for Medical 
Home Models, while also avoiding the counterintuitive situation where 
the minimum risk level is lower in the 2018 QP Performance Period than 
it was in the 2017 QP Performance Period. We also note that this policy 
will also allow for a smaller increase in the standard from the 2018 QP 
Performance Period (2.5 percent) to the 2019 Performance Period (3 
percent). We are finalizing our more gradual ramp-up between the 2019 
and 2021 QP Performance Periods as proposed.
    We are finalizing in Sec.  414.1415(c)(4)(i)(B) through (E) that to 
be an Advanced APM, a Medical Home Model must require that the total 
annual amount that an APM Entity potentially owes us or foregoes under 
the Medical Home Model be at least the following:
     For QP Performance Period 2018, 2.5 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
     For QP Performance Period 2019, 3 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
     For QP Performance Period 2020, 4 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
     For QP Performance Periods 2021 and later, 5 percent of 
the average estimated total Medicare Parts A and B revenue of all 
providers and suppliers in participating APM Entities.
d. Summary of Final Policies
    In summary, we are finalizing the following policies:
     We are finalizing our proposal to exempt any APM Entities 
in Round 1 of the Comprehensive Primary Care Plus (CPC+) Model, which 
is a Medical Home Model as of January 1, 2017 from the requirement 
that, beginning in the 2018 QP Performance Period, the Medical Home 
Model financial risk standard applies only to an APM Entity that is 
participating in a Medical Home Model if it has fewer than 50 eligible 
clinicians in its parent organization by amending Sec.  414.1415(c)(2) 
and adding Sec.  414.1415(c)(7). We are also making accompanying edits 
to our discussion of the 50 eligible clinician limit in Medicaid 
Medical Home Models at Sec.  414.1420(d)(2), Sec.  414.1415(d)(4), and 
adding Sec.  414.1420(d)(8).
     We are amending Sec.  414.1415(c)(3)(i)(A) and 
(c)(4)(i)(A) through (E) as proposed to more clearly define the 
generally applicable revenue-

[[Page 53841]]

based nominal amount standard and the Medical Home Model revenue-based 
nominal amount standard as a percentage of the average estimated total 
Medicare Parts A and B revenue of all providers and suppliers in 
participating APM Entities.
     We are amending Sec.  414.1415(c)(3)(i)(A) to state that 
the generally applicable revenue-based nominal amount standard remains 
at 8 percent of the average estimated total Medicare Parts A and B 
revenue of providers and suppliers in participating APM Entities for 
the 2019 and 2020 QP Performance Periods. We will address the standard 
for QP Performance Periods after 2020 through subsequent rulemaking.
     We are amending Sec.  414.1415(c)(4)(i)(B) through (E) to 
provide that, to be an Advanced APM, a Medical Home Model must require 
that the total annual amount that an APM Entity potentially owes CMS or 
foregoes under the Medical Home Model be at least the following 
amounts:
    ++ For QP Performance Period 2018, 2.5 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
    ++ For QP Performance Period 2019, 3 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
    ++ For QP Performance Period 2020, 4 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
    ++ For QP Performance Period 2021 and later, 5 percent of the 
average estimated total Medicare Parts A and B revenue of all providers 
and suppliers in participating APM Entities.
5. Qualifying APM Participant (QP) and Partial QP Determinations
a. Overview
    We finalized policies relating to QP and Partial QP determinations 
in the CY 2017 Quality Payment Program final rule (81 FR 77433-77450). 
We finalized that the QP Performance Period will run from January 1 
through August 31 of the calendar year that is 2 years prior to the 
payment year (81 FR 77446). In the CY 2018 Quality Payment Program 
proposed rule, we proposed to refer to this time period for the 
Medicare Option as the Medicare QP Performance Period (82 FR 30171). As 
we discuss in sections II.D.6.d.(3)(a) and II.D.6.d.(3)(b) of this 
final rule with comment period, we are not finalizing the term Medicare 
QP Performance Period.
b. Summary of Proposals
    Because some Advanced APMs may start or end during a QP Performance 
Period, we proposed the following in the CY 2018 Quality Payment 
Program proposed rule:
     We proposed to calculate QP Threshold Scores for APM 
Entities in Advanced APMs that are actively tested continuously for a 
minimum of 60 days during the QP Performance Period and start or end 
during the QP Performance Period using only the dates that APM Entities 
were able to participate in active testing in the Advanced APM per the 
terms of the Advanced APM, not the full QP Performance Period. We 
proposed to add this policy to Sec.  414.1425(c)(6) (82 FR 30175).
     We proposed to make QP determinations under Sec.  
414.1425(c)(4), for eligible clinicians participating in multiple 
Advanced APMs using the full QP Performance Period even if the eligible 
clinician participates in one or more Advanced APMs that start or end 
during the QP Performance Period (82 FR 30175 through 30176).
     We proposed to amend our regulations to make clear that 
under Sec.  414.1425(c)(4), if an eligible clinician is determined to 
be a QP based on participation in multiple Advanced APMs, but any of 
the APM Entities in which the eligible clinician participates 
voluntarily or involuntarily terminates from the Advanced APM before 
the end of the QP Performance Period, the eligible clinician is not a 
QP (82 FR 30176).
c. Advanced APMs Starting or Ending During a QP Performance Period
    We acknowledged in the CY 2018 Quality Payment Program proposed 
rule that there may be Advanced APMs that start after January 1 of the 
QP Performance Period for a year and that there may also be Advanced 
APMs that end prior to the August 31 end of the QP Performance Period 
for a year (82 FR 30175). By ``start'' and ``end,'' in this context, we 
explained that we mean that the period of active testing of the model 
starts or ends such that there is no opportunity for any APM Entity to 
participate in the Advanced APM before it starts or to participate in 
it after it ends. We explained that we consider the active testing 
period to mean the dates within the performance period specific to the 
model, which is also the time period for which we consider payment 
amounts or patient counts through the Advanced APM when we make QP 
determinations. We explained that an Advanced APM is in active testing 
if APM Entities are furnishing services to beneficiaries and those 
services will count toward the APM Entity's performance in the Advanced 
APM. We proposed to modify our policies regarding the timeframe(s) for 
which payment amount and patient count data are included in the QP 
payment amount and patient count threshold calculations for Advanced 
APMs that start after January 1 or end before August 31 in a given QP 
Performance Period (82 FR 30175). In these situations, we would 
calculate QP Threshold Scores using only data in the numerator and 
denominator for the dates that APM Entities were able to participate in 
active testing of the Advanced APM, per the terms of the Advanced APM, 
so long as APM Entities were able to participate in the Advanced APM 
for 60 or more continuous days during the QP Performance Period. We 
proposed to add this policy to Sec.  414.1425(c)(6) (82 FR 30175). The 
QP Threshold Score would be calculated at the APM Entity level or the 
Affiliated Practitioner level as set forth in Sec.  414.1425(b); this 
change would not affect our established policy as to which list of 
eligible clinicians, the Participation List or Affiliated Practitioner 
List, would be used.
    We sought comment on these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: The majority of commenters supported our proposals. These 
commenters agreed with CMS's view that in situations where active 
testing of the Advanced APM begins after January 1 or ended prior to 
August 31 of the QP Performance Period, using the full QP Performance 
Period data in the denominator of the QP threshold calculation could be 
unfair to eligible clinicians. These commenters suggested that making 
QP determinations based on dates on which APM Entities participated in 
active testing of the Advanced APM would prevent those APM Entities and 
eligible clinicians from being unfairly disadvantaged in QP 
determinations. These commenters supported our proposal to require at 
least 60 continuous days of active testing of and Advanced APM during 
the QP Performance Period, stating that 60 days is an acceptable 
minimum length of time for APM Entities to be participating in the 
active testing of an Advanced APM.
    Response: We appreciate the commenters' support of our proposals.
    Comment: Some commenters stated that CMS should calculate QP 
Threshold Scores for APM entities in Advanced APMs that are actively 
tested continuously for a minimum of 90

[[Page 53842]]

rather than 60 days. These commenters noted that while 60 days is the 
shortest period between two snapshot dates (June 30 through August 31), 
90 days is currently the shortest possible length of time we would use 
to make QP determinations (January 1 through March 31). These 
commenters also stated that a 90 day active testing period is also more 
appropriate as it provides additional time for the participating APM 
entities to be able to meet the relevant QP threshold.
    Response: We appreciate the commenters' feedback. Although 90 days 
is currently the shortest period of time we use to make QP 
determinations (January 1-March 31) we believe that calculating QP 
threshold scores for Advanced APMs that are actively tested 
continuously for a minimum of 60 days rather than 90 days will allow 
more eligible clinicians the opportunity to attain QP status. While 90 
days may provide more time to meet the relevant QP thresholds, we 
believe 60 days provides sufficient time to measure the participation 
of APM entities and eligible clinicians in Advanced APMs. We also note 
that some eligible clinicians may attain QP status based on 60 days of 
participation, and we believe that it is appropriate to make that 
opportunity available in circumstances where active testing of the 
Advanced APM begins after January 1 or ended prior to August 31 of the 
QP Performance Period.
    Comment: One commenter suggested that CMS should apply this 
proposed policy to all QP determinations, including those made under 
the All-Payer Combination Option. The commenter suggested that doing so 
would benefit APM Entities and eligible clinicians who participate in 
multiple Advanced APMs and Other Payer Advanced APMs.
    Response: We note that we did not propose a similar policy for the 
All-Payer Combination Option. While we generally seek to align the 
policies in the Medicare Option and the All-Payer Combination Option, 
we do not believe that a similar policy is appropriate for the All-
Payer Combination Option. We believe that doing so could be burdensome 
to payers, APM Entities, and eligible clinicians because it may require 
the submission of additional information. Moreover, in order for an 
eligible clinicians to become a QP through the All Payer Combination 
Option, the eligible clinician must participate in at least one 
Advanced APM and at least one Other Payer Advanced APM. It is unlikely 
that these two (or more) payment arrangements would have the same start 
and end dates. As such, it would be unclear which time period should be 
used when making the QP threshold calculations especially as we will 
make QP determinations under both the Medicare Option and All-Payer 
Combination Option based on one period of time (e.g., January 1-March 
31; January 1-June 30; January 1-August 31).
    Comment: One commenter that supported CMS's proposal was under the 
impression that CMS proposed to change the QP Performance Period to run 
from January 1 through June 30.
    Response: We clarify that we did not propose to change the Medicare 
QP Performance Period to begin from January 1 and end on June 30. We 
did not propose to revise the Medicare QP Performance Period that runs 
from January 1 and ends on August 31 of the calendar year that is 2 
years prior to the payment year. We proposed to modify the All-Payer QP 
Performance Period from January 1 through August 31 to instead 
establish a performance period from January 1 through June 30 of the 
calendar year that is 2 years prior to the payment year (82 FR 30171). 
As we discuss further in sections II.D.6.d.(3)(a) and (b) of this final 
rule with comment period, we note that we are not finalizing separate 
Medicare and All-Payer QP Performance Periods as proposed. The term QP 
Performance Period will be used for both the Medicare and All-Payer 
Combination Option, and the QP Performance Period will begin on January 
1 and end on August 31 of the calendar year that is 2 years prior to 
the payment year.
    Final Action: After considering public comments, we are finalizing 
our proposal to calculate QP Threshold Scores using only data in the 
numerator and denominator for the dates that APM Entities were able to 
participate in active testing of the Advanced APM, per the terms of the 
Advanced APM, so long as APM Entities were able to participate in the 
Advanced APM for 60 or more continuous days during the QP Performance 
Period. We clarify that we are adding this policy to Sec.  
414.1425(c)(7)(i).
    We also proposed to make QP and Partial QP determinations for 
eligible clinicians who participate in multiple Advanced APMs as set 
forth by Sec. Sec.  414.1425(c)(4) and 414.1425(d)(2) of our regulation 
using the full QP Performance Period even if the eligible clinician 
participates in one or more Advanced APMs that start or end during the 
QP Performance Period (82 FR 30175-30176).
    We sought comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Two commenters supported CMS's proposal, suggesting that 
for eligible clinicians participating in multiple Advanced APMs, using 
the full QP Performance Period to make QP determinations is appropriate 
even if the eligible clinician participates in one or more Advanced 
APMs that start or end during the Medicare QP Performance Period.
    Response: We thank commenters for their support of our proposal.
    Final Action: After considering public comments, we are finalizing 
our proposal to make QP and Partial QP determinations for eligible 
clinicians who participate in multiple Advanced APMs as set forth by 
Sec. Sec.  414.1425(c)(4) and 414.1425(d)(2) using the full QP 
Performance Period even if the eligible clinician participates in one 
or more Advanced APMs that start or end during the QP Performance 
Period. We are codifying this policy at Sec.  414.1425(c)(7)(ii).
    With the exception of QP determinations for individual eligible 
clinicians who participate in multiple Advanced APMs, we believe it is 
appropriate to require that an Advanced APM must be actively tested for 
a minimum of 60 continuous days during the QP Performance Period in 
order for the payment amount or patient count data to be considered for 
purposes of QP determinations for the year because it is important that 
the QP determination be based on a measure of meaningful participation 
in an Advanced APM.
    Accordingly, we proposed to make QP determinations for all QP 
determination snapshot dates that fall after the Advanced APM meets the 
minimum time requirement of 60 continuous days whether the Advanced APM 
starts or ends during the QP Performance Period. We would not make a QP 
or Partial QP determination for participants in Advanced APMs that are 
not actively tested for a period of at least 60 continuous days during 
the Medicare QP Performance Period (82 FR 30176).
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing our proposal to make QP 
determinations for all QP determination snapshot dates that fall after 
the Advanced APM meets the minimum time requirement of 60 continuous 
days whether the Advanced APM starts or ends during the QP Performance 
Period.

[[Page 53843]]

d. Participation in Multiple Advanced APMs
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
to amend Sec. Sec.  414.1425(c)(4) and (d)(4) to better reflect our 
intended policy for QP determinations and Partial QP determinations for 
eligible clinicians who are included in more than one APM Entity group 
and none of the APM Entity groups in which the eligible clinician is 
included meets the corresponding QP or Partial QP threshold, or those 
who are Affiliated Practitioners (82 FR 30176). As we explained in the 
CY 2017 Quality Payment Program final rule, eligible clinicians may 
become QPs through any of the assessments conducted for the three 
snapshot dates: March 31, June 30, and August 31 (81 FR 77446-77447). 
If the APM Entity group meets the QP threshold under this first 
assessment, then all eligible clinicians in the APM Entity group will 
be QPs unless the APM Entity's participation in the Advanced APM is 
voluntarily or involuntarily terminated before the end of the QP 
Performance Period, or in the event of a program integrity violation by 
eligible clinician or APM as set forth in Sec.  414.1460. We stated 
these same procedures apply to the QP determination made for individual 
eligible clinicians on an APM Entity's Affiliated Practitioner List or 
individual eligible clinicians in multiple Advanced APMs whose APM 
Entity groups did not meet the QP threshold.
    We also proposed to amend our regulations to make clear that under 
Sec.  414.1425(c)(4), if an eligible clinician is determined to be a QP 
based on participation in multiple Advanced APMs, but any of the APM 
Entities in which the eligible clinician participates voluntarily or 
involuntarily terminates from the Advanced APM before the end of the QP 
Performance Period, the eligible clinician is not a QP. We proposed to 
make the same clarification for Partial QP determinations under Sec.  
414.1425(d)(4). These clarifying edits specify that this policy applies 
only within the context of QP and Partial QP determinations based on 
participation in multiple Advanced APMs, not for all QP determinations. 
Accordingly, for example, if an eligible clinician is a QP through 
participation in each of two Advanced APMs under Sec.  414.1425(b)(1), 
and one APM Entity voluntarily or involuntarily terminates from one of 
those Advanced APMs, the eligible clinician is still a QP. However, if 
the eligible clinician is a QP through participation in multiple 
Advanced APMs under Sec.  414.1425(c)(4), and any APM Entity that 
eligible clinician participates in that counts towards the QP 
determination voluntarily or involuntarily terminates from the Advanced 
APM before the end of the QP Performance Period, the eligible clinician 
is no longer a QP.
    We sought comment on these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Three commenters expressed concern that CMS's polices are 
different for individuals than they are for APM Entities. One commenter 
questioned why this policy would be different for individuals than for 
APM Entities. Specifically, the commenter noted that when an eligible 
clinician participates in multiple Advanced APMs, but neither APM 
Entity through which they participate obtain QP status, the eligible 
clinician's data are then used to make an individual QP threshold 
calculation, including data from the entire QP Performance Period 
regardless of any of their Advanced APM start or end dates. One of 
these commenters believes that this policy is contradictory to the 
proposal that an eligible clinician reaching QP status through an 
individual calculation will lose QP status if any of the APM Entities 
through which they participated terminates from its Advanced APM before 
the end of the Medicare QP Performance Period.
    Response: We clarify that it is necessary to include data from the 
entire QP Performance Period, regardless of any Advanced APM start or 
end dates, to make an individual QP threshold calculation when an 
eligible clinician participates in multiple Advanced APMs to ensure 
that the period of assessment for calculating their QP threshold score 
is consistent across the Advanced APMs in which the eligible clinician 
participates. We further clarify that our policy for rescinding an 
eligible clinician's QP status upon the voluntary or involuntary 
termination of an APM Entity from an Advanced APM before the end of the 
QP Performance Period is consistent, whether the eligible clinician 
initially achieved QP status through a determination at the APM Entity 
level or as an individual. In both scenarios, if the APM Entity through 
which the eligible clinician participated in the Advanced APM 
terminates from the Advanced APM before the end of the QP Performance 
Period, the eligible clinician participating as part of that APM Entity 
will lose QP status.
    Comment: One commenter supported CMS's proposal that if one or more 
of the APM Entities in which the eligible clinician participates meets 
the QP threshold, the eligible clinician becomes a QP.
    Response: We appreciate the commenter's support.
    Comment: Two commenters supported CMS's proposal to clarify that if 
an eligible clinician is determined to be a QP or Partial QP based on 
his or her combined participation in multiple Advanced APMs, if any APM 
entity that is included for purposes of the QP determination 
voluntarily or involuntarily terminates from the Advanced APM before 
the end of the QP Performance Period, the eligible clinician is no 
longer a QP.
    Response: We thank commenters for their support of this proposal.
    Comment: Three commenters did not support CMS's proposal that 
eligible clinicians who participate in multiple Advanced APMs will lose 
QP status if any of the APM Entities through which they participated in 
the Advanced APM terminate their participation from the Advanced APM 
before the end of the QP Performance Period. These commenters believe 
this policy would unfairly penalize eligible clinicians that may 
otherwise have obtained QP status and qualified for the APM incentive 
payment. These commenters noted that eligible clinicians are only 
assessed individually using their participation in multiple Advanced 
APMs if none of the APM Entities through which they participated meet 
the QP thresholds. These commenters expressed concern that as the QP 
thresholds increase in later years of the Quality Payment Program, this 
situation will be more common. These commenters recommended that CMS 
remove the APM Entity that terminates from the QP threshold 
calculation, but still calculate the QP thresholds for the eligible 
clinicians in these circumstances using their participation in APM 
Entities that did not terminate.
    Response: These public comments have led us to consider a situation 
which an individual eligible clinician is in more than two APM Entities 
and Advanced APMs. We acknowledge that there could be a situation where 
one of those APM Entities through which the eligible clinician 
participates in an Advanced APM terminates prior to the end of the QP 
Performance Period, but the individual eligible clinician is in 
multiple other APM Entities, through which the eligible clinician is in 
other Advanced APMs, and those APM Entities have not terminated their 
participation in an Advanced APM prior to the end of the QP Performance 
Period. Because it would be possible for

[[Page 53844]]

such a eligible clinician to attain QP or Partial QP status based 
solely on performance in remaining APM Entities that did not terminate 
prior to the end of the QP Performance Period, in this scenario, we 
will evaluate whether the individual eligible clinician's participation 
in the remaining Advanced APMs would meet the relevant QP or Partial QP 
Threshold.
    Comment: One commenter questioned how CMS will identify the 
services furnished by the eligible clinician through the APM Entity 
that terminated and to exclude other services performed by the eligible 
clinician when these calculations are made at the individual level, but 
also supported our intent to ensure that services are not double-
counted.
    Response: As we discussed in the CY 2017 Quality Payment Program 
final rule, because we will make QP determinations using claims 
analyses, which enables us to connect services for beneficiaries to an 
eligible clinician's NPI, we would only need to add the numerator and 
denominator values together and adjust for any duplication in the 
numerator or denominator. The formulas would be the same as if 
calculated for the group but based on the individual eligible 
clinician's activity at the NPI level (81 FR 77443). We did not propose 
any changes to this approach.
    Final Action: After considering public comments, we are amending 
Sec. Sec.  414.1425(c)(6) and (d)(4) to reflect our policy for the 
situation where an eligible clinician is in multiple APM Entities 
participating in multiple Advanced APMs, and it would be possible for 
this eligible clinician to attain QP or Partial QP status based solely 
on performance in non-terminating APM Entities when one of the APM 
Entities terminates prior to the end of the QP Performance Period. In 
this situation, we will evaluate whether the individual eligible 
clinician's participation in the remaining Advanced APMs would meet the 
relevant QP or Partial QP Threshold.
e. Summary of Final Policies
    In summary, we are finalizing the following policies:
     We are finalizing that we will calculate QP Threshold 
Scores for participants in Advanced APMs that are actively tested 
continuously for a minimum of 60 days during the QP Performance Period 
and start or end during the QP Performance Period based on data only 
for the dates that APM Entities were able to participate in the 
Advanced APM per the terms of the Advanced APM, not for the full QP 
Performance Period. We are codifying this policy at Sec.  
414.1425(c)(7)(i).
     We are finalizing that we will make QP determinations 
under Sec.  414.1425(c)(4) for eligible clinicians participating in 
multiple Advanced APMs using the full QP Performance Period even if the 
eligible clinician participates in one or more Advanced APMs that start 
or end during the QP Performance Period. We are codifying this policy 
at Sec.  414.1425(c)(7)(ii).
     We are finalizing amendments to Sec. Sec.  414.1425(c)(6) 
and (d)(4) to reflect our policy for the situation where an eligible 
clinician is in multiple APM Entities participating in multiple 
Advanced APMs, and it would be possible for this eligible clinician to 
attain QP or Partial QP status based solely on performance in non-
terminating APM Entities when one of the APM Entities terminates prior 
to the end of the QP Performance Period. We will evaluate whether the 
individual eligible clinician's participation in the remaining Advanced 
APMs would meet the relevant QP or Partial QP Threshold.
6. All-Payer Combination Option
a. Overview
    Section 1833(z)(2)(B)(ii) of the Act requires that beginning in 
payment year 2021, in addition to the Medicare Option, eligible 
clinicians may become QPs through the Combination All-Payer and 
Medicare Payment Threshold Option, which we refer to as the All-Payer 
Combination Option. In the CY 2017 Quality Payment Program final rule, 
we finalized our overall approach to the All-Payer Combination Option 
(81 FR 77459). The Medicare Option focuses on participation in Advanced 
APMs, and we make determinations under this option based on Medicare 
Part B covered professional services attributable to services furnished 
through an APM Entity. The All-Payer Combination Option does not 
replace or supersede the Medicare Option; instead, it will allow 
eligible clinicians to become QPs by meeting the QP thresholds through 
a pair of calculations that assess Medicare Part B covered professional 
services furnished through Advanced APMs, and a combination of both 
Medicare Part B covered professional services furnished through 
Advanced APMs and services furnished through Other Payer Advanced APMs. 
We finalized that beginning in payment year 2021, we will conduct QP 
determinations sequentially so that the Medicare Option is applied 
before the All-Payer Combination Option (81 FR 77438). The All-Payer 
Combination Option encourages eligible clinicians to participate in 
payment arrangements with payers other than Medicare that have payment 
designs that satisfy the Other Payer Advanced APM criteria. It also 
encourages sustained participation in Advanced APMs across multiple 
payers.
    We finalized that the QP determinations under the All-Payer 
Combination Option are based on payment amounts or patient counts as 
illustrated in Tables 36 and 37, and Figures 1 and 2 (81 FR 77460-
77461). We also finalized that, in making QP determinations, we will 
use the Threshold Score that is most advantageous to the eligible 
clinician toward achieving QP status for the year, or if QP status is 
not achieved, Partial QP status for the year (81 FR 77475).

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    Unlike the Medicare Option, where we have access to all of the 
information necessary to determine whether an APM meets the criteria to 
be an Advanced APM, we cannot determine whether an other payer 
arrangement meets the criteria to be an Other Payer Advanced APM 
without receiving the required information from an external source. 
Similarly, we do not have the necessary payment amount and patient 
count information to determine under the All-Payer Combination Option 
whether an eligible clinician meets the payment amount or patient count 
threshold to be a QP without receiving the required information from an 
external source.
    We finalized the process that eligible clinicians can use to seek a 
QP determination under the All-Payer Combination Option (81 FR 77478-
77480):
     The eligible clinician submits to CMS sufficient 
information on all relevant payment arrangements with other payers;
     Based upon that information CMS determines that at least 
one of those payment arrangements is an Other Payer Advanced APM; and
     The eligible clinician meets the relevant QP thresholds by 
having sufficient payments or patients attributed to a combination of 
participation in Other Payer Advanced APMs and Advanced APMs.
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
additional details around our plans for implementing the All Payer 
Combination Option and we also proposed certain modifications to our 
previously finalized policies (82 FR 30177 through 30207).
    We address the following topics in this section of this final rule 
with comment period: (1) Other Payer Advanced APM Criteria; (2) 
Determination of Other Payer Advanced APMs; and (3) Calculation of All-
Payer Combination Option Threshold Scores and QP Determinations.

[[Page 53847]]

b. Other Payer Advanced APM Criteria
(1) In General
    Our goal is to align the Advanced APM criteria under the Medicare 
Option and the Other Payer Advanced APM criteria under the All-Payer 
Combination Option as permitted by statute and as feasible and 
appropriate. We believe this alignment will help simplify the Quality 
Payment Program and encourage participation in Other Payer Advanced 
APMs.
    In the CY 2017 Quality Payment Program final rule, we finalized 
that in general, an other payer arrangement with any payer other than 
traditional Medicare, including Medicare Health Plans, which include 
Medicare Advantage, Medicaid-Medicaid Plans, 1876 Cost Plans, and 
Programs of All Inclusive Care for the Elderly (PACE) plans, will be an 
Other Payer Advanced APM if it meets all three of the following 
criteria:
     The other payer arrangement requires at least 50 percent 
of participating eligible clinicians in each participating APM Entity, 
or each hospital if hospitals are the APM Entities, to use CEHRT to 
document and communicate clinical care (81 FR 77464-77465);
     The other payer arrangement requires that quality measures 
comparable to measures under the MIPS quality performance category 
apply, which means measures that are evidence-based, reliable and 
valid; and, if available, at least one measure must be an outcome 
measure (81 FR 77466); and
     The other payer arrangement either: (1) Requires APM 
Entities to bear more than nominal financial risk if actual aggregate 
expenditures exceed expected aggregate expenditures (under either the 
generally applicable or Medicaid Medical Home Model standards for 
nominal amount of financial risk, as applicable); or (2) is a Medicaid 
Medical Home Model that meets criteria comparable to Medical Home 
Models expanded under section 1115A(c) of the Act (81 FR 77466-77467).
(2) Summary of Proposals
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
the following:
     We proposed that an other payer arrangement would be 
considered to meet the nominal amount standard if, under the terms of 
the other payer arrangement, the total amount that an APM Entity 
potentially owes the payer or foregoes is equal to at least: for the 
2019 and 2020 QP Performance Periods, 8 percent of the total combined 
revenues from the payer of providers and suppliers in participating APM 
Entities.
     We proposed that to be an Other Payer Advanced APM, a 
Medicaid Medical Home Model must require that the total annual amount 
that an APM Entity potentially owes or foregoes under the Medicaid 
Medical Home Model must be at least:
    ++ For QP Performance Period 2019, 3 percent of the APM Entity's 
total revenue under the payer.
    ++ For QP Performance Period 2020, 4 percent of the APM Entity's 
total revenue under the payer.
    ++ For QP Performance Period 2021 and later, 5 percent of the APM 
Entity's total revenue under the payer.
(3) Other Payer Medical Home Models
    In the CY 2017 Quality Payment Program final rule, we finalized 
definitions of Medical Home Model and Medicaid Medical Home Model at 
Sec.  414.1305. The statute does not define ``medical homes,'' but 
sections 1848(q)(5)(C)(i), 1833(z)(2)(B)(iii)(II)(cc)(BB), 
1833(z)(2)(C)(iii)(II)(cc)(BB), and 1833(z)(3)(D)(ii)(II) of the Act 
make medical homes an instrumental piece of the Quality Payment 
Program.
    We recognize that there may be medical homes that are operated by 
other payers that may be appropriately considered medical home models 
under the All-Payer Combination Option. Examples of these arrangements 
may include those aligned with the Comprehensive Primary Care Plus 
(CPC+) Model. Therefore, in the CY 2018 Quality Payment Program 
proposed rule, we sought comment on whether we should define the term 
Other Payer Medical Home Model as an other payer arrangement that is 
determined by us to have the following characteristics:
     The other payer arrangement has a primary care focus with 
participants that primarily include primary care practices or 
multispecialty practices that include primary care physicians and 
practitioners and offer primary care services. For the purposes of this 
provision, primary care focus means the inclusion of specific design 
elements related to eligible clinicians practicing under one more of 
the following Physician Specialty Codes: 01 General Practice; 08 Family 
Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37 
Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 
Clinical Nurse Specialist; and 97 Physician Assistant;
     Empanelment of each patient to a primary clinician; and
     At least four of the following:
    ++ Planned coordination of chronic and preventive care.
    ++ Patient access and continuity of care.
    ++ Risk-stratified care management.
    ++ Coordination of care across the medical neighborhood.
    ++ Patient and caregiver engagement.
    ++ Shared decision-making.
    ++ Payment arrangements in addition to, or substituting for, fee-
for-service payments (for example, shared savings or population-based 
payments).
    We also explained that similar to Medical Home Models and Medicaid 
Medical Home Models, we believe that Other Payer Medical Home Models 
could be considered unique types of other payer arrangements for 
purposes of the Quality Payment Program. We anticipate that 
participants in these arrangements may generally be more limited in 
their ability to bear financial risk than other entities because they 
may be smaller and predominantly include primary care practitioners, 
whose revenues are a smaller fraction of the patients' total cost of 
care than those of other eligible clinicians. Because of these factors, 
we explained that we believe it may be appropriate to determine whether 
an Other Payer Medical Home Model satisfies the financial risk 
criterion by using special Other Payer Medical Home Model financial 
risk and nominal amount standards, which could be different from the 
generally applicable Other Payer Advanced APM standards and would be 
identical to the Medicaid Medical Home Model financial risk and nominal 
amount standards (82 FR 30180).
    We noted a particular interest in, and sought comment on, whether 
there are payment arrangements that currently exist that would meet 
this definition. We encouraged commenters to suggest whether such 
payment arrangements would meet the existing generally applicable Other 
Payer Advanced APM financial risk and nominal amount standards. We also 
requested comments on any special considerations that might be relevant 
when establishing a definition for a medical home model standard for 
payers with payment arrangements that would not fit under the Medical 
Home Model or Medicaid Medical Home Model definitions, including how 
the 50 clinician cap we finalized in the CY 2017 Quality Payment 
Program final rule (81 FR 77428-77429) Medical Home Model nominal 
amount standard would apply.
    The following is a summary of the public comments received in 
response

[[Page 53848]]

to our request for comment and our responses:
    Comment: Several commenters supported CMS creating an Other Payer 
Medical Home Model definition. One commenter stated that there is no 
reason to allow for a Medical Home Model standard under both Medicare 
and Medicaid but not for other payers. Some of these commenters also 
suggested that we align the Other Payer Medical Home Model definition 
with the Medical Home Model and Medicaid Medical Home Model 
definitions.
    Response: We appreciate the support from these commenters. Given 
that we still have limited knowledge about payment arrangements between 
private payers and eligible clinicians, we believe that it is 
appropriate for us to continue to evaluate whether an Other Payer 
Medical Home Model definition is appropriate. We note that throughout 
the APM incentive portions of the Quality Payment Program, one of our 
goals is to align policies between the Medicare Option and the All-
Payer Combination Option to the extent feasible and appropriate.
    Comment: Some commenters suggested that CMS consider making some 
changes to the suggested Other Payer Medical Home Model definition. A 
few commenters suggested that specialty-focused medical homes should be 
included in the Other Payer Medical Home Model definition. A few 
commenters also suggested that CMS do not include the 50 eligible 
clinician limit in the Other Payer Medical Home Model definition.
    Response: One of our goals is to align policies between the 
Medicare Option and the All-Payer Combination Option to the extent 
possible. In the CY 2017 Quality Payment Program final rule, in our 
discussion of the Medical Home Model and Medicaid Medical Home Model 
definitions, we noted that we believe an APM cannot be a Medical Home 
Model unless it has a primary care focus with an explicit relationship 
between patients and practitioners (81 FR 77403). If we propose this 
definition or a similar definition in the future, we will consider at 
that time whether a 50 eligible clinician limit or other similar limit 
would be appropriate.
    Final Action: We are not establishing a definition of Other Payer 
Medical Home Model. However, we may consider creating such a definition 
in future rulemaking. We welcome further public comment on this topic.
(4) Financial Risk for Monetary Losses
    In the CY 2017 Quality Payment Program final rule, we finalized 
policies to assess whether an other payer arrangement requires 
participating APM Entities to bear more than nominal financial risk if 
aggregate expenditures exceed expected aggregated expenditures. This 
Other Payer Advanced APM criterion has two components: A financial risk 
standard and a nominal amount standard. The financial risk standard 
defines what it means for an APM Entity to bear financial risk if 
actual aggregate expenditures exceed expected aggregate expenditures 
under an other payer arrangement. We finalized a generally applicable 
financial risk standard and a Medicaid Medical Home Model financial 
risk standard for Other Payer Advanced APMs. (81 FR 77466 through 
77474).
    We finalized that for an other payer arrangement to meet the 
generally applicable financial risk standard for Other Payer Advanced 
APMs, if an APM Entity's actual aggregate expenditures exceed expected 
aggregate expenditures during a specified performance period, the payer 
must:
     Withhold payment of services to the APM Entity and/or the 
APM Entity's eligible clinicians;
     Reduce payment rates to APM Entity and/or the APM Entity's 
eligible clinicians; or
     Require direct payments by the APM Entity to the payer (81 
FR 77467).
    We also finalized that for a Medicaid Medical Home Model to be an 
Other Payer Advanced APM, if the APM Entity's actual aggregate 
expenditures exceed expected aggregate expenditures during a specified 
performance period, the Medicaid Medical Home Model must:
     Withhold payment of services to the APM Entity and/or the 
APM Entity's eligible clinicians;
     Reduce payment rates to APM Entity and/or the APM Entity's 
eligible clinicians;
     Require direct payments by the APM Entity to the payer; or
     Require the APM Entity to lose the right to all or part of 
an otherwise guaranteed payment or payments (81 FR 77468-77469).
(a) Generally Applicable Nominal Amount Standard
(i) Marginal Risk and Minimum Loss Rate
    The generally applicable nominal amount standard that we finalized 
in the CY 2017 Quality Payment Program final rule for Other Payer 
Advanced APMs differs from the generally applicable nominal amount 
standard for Advanced APMs in two ways (81 FR 77471).
    First, the finalized generally applicable nominal amount standard 
for Advanced APMs only requires an APM to meet one measure of risk--
total risk (81 FR 77424). The finalized generally applicable nominal 
amount standard for Other Payer Advanced APMs involves assessment of 
the following three measures of risk:
     Marginal risk--the percentage of the amount by which 
actual expenditures exceed expected expenditures for which an APM 
Entity would be liable under the payment arrangement.
     Minimum loss rate--a percentage by which actual 
expenditures may exceed expected expenditures without triggering 
financial risk.
     Total risk--the maximum potential payment for which an APM 
Entity could be liable under a payment arrangement.
    We reiterate that as we described in the CY 2017 Quality Payment 
Program final rule, although we did not formally adopt marginal risk or 
minimum loss rate criteria for Advanced APMs, we pointed out that all 
current Advanced APMs would meet these standards, and that we intend 
that all future Advanced APMs would meet the three measures of risk as 
well (81 FR 77426). Therefore, we do not expect the application of the 
different criteria between Advanced APMs and Other Payer Advanced APMs 
to produce meaningfully different results in terms of actual risk faced 
by participants.
    Second, the finalized generally applicable Advanced APM nominal 
amount standard allows for total risk to be defined in one of two ways, 
based on expected expenditures (the benchmark-based standard) or based 
on revenue (the revenue-based standard) (81 FR 77427). In contrast, the 
finalized Other Payer Advanced APM generally applicable nominal amount 
standard is only based on expected expenditures (81 FR 77471).
    In the CY 2017 Quality Payment program final rule, we sought 
comments on using the expected expenditures approach for the generally 
applicable Other Payer Advanced APM nominal amount standard.
    In the CY 2018 Quality Payment Program proposed rule, we did not 
propose to modify the marginal risk and minimum loss rates as finalized 
in the 2017 Quality Payment Program final rule as part of the generally 
applicable nominal amount standard for Other Payer Advanced APMs. We 
noted that we continue to believe that using these measures of risk 
will ensure that payment arrangements involving other payers and APM 
Entities or eligible clinicians cannot be engineered in such a way as 
to provide eligible clinicians

[[Page 53849]]

an avenue to QP status through an Other Payer Advanced APM that 
technically meets the financial risk criterion but carries a very low 
risk of losses based on performance. Because we do not have direct 
control over the design of Other Payer Advanced APMs, we noted that we 
believe the use of a multi-factor nominal amount standard to assess 
financial risk provides greater assurance that Other Payer Advanced 
APMs will involve true financial risk in accordance with statutory 
requirements. We stated that including marginal risk and minimal loss 
rate requirements as components of the nominal amount standard assures 
that the payment arrangements that we could determine are Other Payer 
Advanced APMs and could contribute to the attainment of QP status are 
similarly rigorous to Advanced APMs. We requested additional comments 
on this approach, and on whether there are potential alternative 
approaches to achieving these goals (82 FR 30181).
    The following is a summary of the public comments received in 
response to this request for comment and our responses:
    Comment: Many commenters supported consistency between the nominal 
amount standards in the Medicare Option and the All-Payer Combination 
Option. Several commenters expressed support for removing the marginal 
risk and minimum loss rate requirements from the Other Payer Advanced 
APM generally applicable nominal amount standard, while two commenters 
supported maintaining the current Other Payer Advanced APM generally 
applicable nominal amount standard.
    Response: We agree with these commenters that creating alignment 
between the Medicare Option and the All-Payer Combination Option is 
generally desirable, wherever possible. We also recognize that 
including marginal risk and minimum loss rate requirements adds 
significant complexity and may make it more challenging for both payers 
and eligible clinicians to participate in the All Payer Combination 
Option. That said, we continue to believe that the use of a multi-
factor nominal amount standard to assess financial risk provides us 
with an important guardrail to ensure that Other Payer Advanced APMs 
will involve true financial risk.
    Final Action: We are not making any changes to this policy at this 
time. We welcome additional comment on this approach. We note that we 
are looking to explore ways to reduce burden within the All-Payer 
Combination Option, and may consider additional changes in future 
rulemaking, as we gain more experience in implementing the All Payer 
Combination Option. We request additional comment on whether we should 
continue to require the marginal risk and minimum loss rate 
requirements, and also on whether there are alternative approaches to 
achieving our goals.
(ii) Generally Applicable Revenue-Based Nominal Amount Standard
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
to add a revenue-based nominal amount standard to the generally 
applicable nominal amount standard for Other Payer Advanced APMs that 
is parallel to the generally applicable revenue-based nominal amount 
standard for Advanced APMs. Specifically, we proposed that an other 
payer arrangement would meet the total risk component of the proposed 
nominal risk standard if, under the terms of the other payer 
arrangement, the total amount that an APM Entity potentially owes the 
payer or foregoes is equal to at least: For the 2019 and 2020 QP 
Performance Periods, 8 percent of the total combined revenues from the 
payer of providers and suppliers in participating APM Entities. This 
standard would be in addition to the previously finalized expenditure-
based standard. We explained that a payment arrangement would only need 
to meet one of the two standards. We would use this standard only for 
other payer arrangements where financial risk is expressly defined in 
terms of revenue in the payment arrangement. We sought comment on this 
proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Many commenters supported CMS's proposal. One commenter 
requested that this 8 percent generally applicable revenue-based 
nominal amount standard be maintained beyond the 2019 and 2020 QP 
Performance Periods.
    Response: We appreciate commenters' support of this proposal. We 
will establish this standard for QP Performance Periods 2019 and 2020 
as proposed, and we anticipate adopting a generally applicable revenue-
based nominal amount standard for QP Performance Periods after 2020 
through future rulemaking.
    Comment: One commenter suggested that the revenue-based nominal 
amount standard should only include physician revenue.
    Response: We do not believe that it would be appropriate to limit 
the revenue-based nominal amount standard to only take physician 
revenue into account, as doing so may not capture the wide variety of 
potential payment arrangements and types of entities in those 
arrangements.
    Comment: One commenter stated that it was still unclear how the 
nominal amount standard under the Medicare Option aligns with the 
nominal amount standard under the All-Payer Combination Option.
    Response: Where possible, we aim to align the Medicare Option and 
the All-Payer Combination Option. We believe that this proposal, by 
creating a revenue-based standard that requires the same percentage of 
revenue be at risk for Other Payer Advanced APMs as is required for 
Advanced APMs and defines revenue in a comparable way, advances that 
goal.
    Final Action: After considering public comments, we are finalizing 
our proposal with one clarification. As we clarified in section 
II.D.4.c.(2)(a) of this final rule with comment period regarding the 
generally applicable revenue-based nominal amount standard for Advanced 
APMs, we will look at the average estimated total Medicare Parts A and 
B revenue of providers and other entities participating in APM 
Entities. Similarly, for the generally applicable revenue-based nominal 
amount standard under the All-Payer Combination Option, we will look at 
the total combined revenues of the providers or other entities under 
the payment arrangement to determine that an other payer arrangement 
would meet the total risk component of the nominal standard if, under 
the terms of the other payer arrangement, the total amount that an APM 
Entity potentially owes the payer or foregoes is equal to at least: For 
the 2019 and 2020 QP Performance Periods, 8 percent of the total 
combined revenues from the payer to providers and other entities under 
the payment arrangement by revising Sec.  414.1420(d)(3)(i).
    For Advanced APMs, we may determine that an APM still meets the 
generally applicable revenue-based nominal amount standard, even if 
risk is not explicitly defined in terms of revenue, by comparing model 
downside risk to the estimated average Medicare revenue of model 
participants. Because we have direct access to Medicare claims data, we 
can estimate such an average. For other payers, we do not have similar 
direct access to claims data. As such, there are significant 
operational challenges to identifying whether an other payer 
arrangement would satisfy the revenue-based nominal amount standard 
when the other payer arrangement does not define risk explicitly in 
terms of revenue.

[[Page 53850]]

Because we do not have direct access to other payer revenue data, we 
could not do this calculation without significant assistance from the 
relevant payer. For this reason, we proposed that the revenue-based 
nominal amount standard would only be applied to other payer 
arrangements in which risk is explicitly defined in terms of revenue, 
as specified in an agreement covering the other payer arrangement.
    We sought comment on this proposal. We did not receive any comments 
in response to this proposal.
    Final Action: We are finalizing our proposal that the revenue-based 
standard would only be applied to other payer arrangements in which 
risk is explicitly defined in terms of revenue, as specified in an 
agreement covering the other payer arrangement. We are codifying this 
policy by revising Sec.  414.1420(d)(3)(i).
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that under the generally applicable nominal amount standard for Other 
Payer Advanced APMs, an other payer arrangement would need to meet 
either the benchmark-based nominal amount standard or the revenue-based 
nominal amount standard and need not meet both. We noted that we 
believe the proposed approach to the nominal amount standard would 
expand the opportunities for other payer arrangements to meet the 
generally applicable nominal amount standard, and would allow closer 
alignment between Medicare and other payers as new payment arrangements 
are introduced and evolve.
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing our proposal that under the 
generally applicable nominal amount standard for Other Payer Advanced 
APMs, an other payer arrangement would need to meet either the 
benchmark-based nominal amount standard or the revenue-based nominal 
amount standard and need not meet both.
    We also sought comment on whether we should consider a different, 
potentially lower, revenue-based nominal amount standard only for small 
practices and those in rural areas that are not participating in a 
Medicaid Medical Home Model for the 2019 and 2020 QP Performance 
Periods (82 FR 30182). We noted we would use the definition of small 
practices and rural areas that is in Sec.  414.1305. We noted that we 
believe that a different, potentially lower, revenue-based nominal 
amount standard for the 2019 and 2020 QP Performance Periods 
specifically for small and rural organizations may allow for increased 
participation in Other Payer Advanced APMs, which may help increase the 
quality and coordination of care beneficiaries receive as a result. 
Specifically, we sought comment on whether such a standard should apply 
only to small and, or, rural practices that are participants in an 
Other Payer Advanced APM, or also to small and/or rural practices that 
join larger APM Entities to participate in APMs. We also sought comment 
on how we should decide where a practice is located to determine 
whether it is operating in a rural area is defined in Sec.  414.1305.
    The following is a summary of the public comments received in 
response to this request for comments and our responses:
    Comment: Some commenters supported a different, lower revenue-based 
nominal amount standard for small and rural practices. One commenter 
urged CMS to further assess rural communities to determine how much 
risk they can handle and the most appropriate kinds of risk--symmetric, 
asymmetric, or another alternative. Another commenter stated that 
creating a different, lower revenue-based nominal amount standard would 
give us the opportunity to engage new practices that would not 
otherwise participate in higher risk models, or those that tried the 
existing higher risk models found the risk levels unworkable and would 
no longer participate anyway.
    Response: We appreciate the comments submitted, and we will 
continue to assess the need for a different revenue-based nominal 
amount standard for small or rural practices or organizations.
    Final Action: We are not creating a different revenue-based nominal 
amount standard for either small practices or rural areas at this time. 
We may address this topic in future rulemaking.
(b) Medicaid Medical Home Model Nominal Amount Standard
    In the CY 2017 Quality Payment Program final rule, in addition to 
the financial risk standard for Medicaid Medical Home Models, we 
finalized that to be an Other Payer Advanced APM, a Medicaid Medical 
Home Model must require that the total annual amount that an APM Entity 
potentially owes or foregoes be at least the following amounts in a 
given performance year:
     In 2019, 4 percent of the APM Entity's total revenues 
under the payer.
     In 2020 and later, 5 percent of the APM Entity's total 
revenues under the payer (81 FR 77472).
    In the CY 2018 Quality Payment Program proposed rule, we 
reconsidered the incremental annual increases we had established for 
the Medicaid Medical Home Model nominal amount standard to take effect 
over several years. Our policy finalized in the CY 2017 Quality Payment 
Program final rule set forth what we envisioned was a gradually 
increasing but achievable amount of risk that would apply over time. In 
general, we still believe this to be true, but recognize that 
establishing an even more gradual increase in risk for Medicaid Medical 
Home Models may better suit many APM Entities in Medicaid Medical Home 
Models that have little experience with risk. To that end, we explained 
that we believe a small reduction of risk in the Medicaid Medical Home 
Model nominal amount standard beginning in the 2019 QP Performance 
Period may allow for greater flexibility in setting financial risk 
thresholds that would encourage more participation in Medicaid Medical 
Home Models and be more sustainable for the type of APM Entities that 
would potentially participate in Medicaid Medical Home Models.
    Therefore, in the CY 2018 Quality Payment Program proposed rule, we 
proposed that to be an Other Payer Advanced APM, a Medicaid Medical 
Home Model must require that the total annual amount that an APM Entity 
potentially owes or foregoes under the Medicaid Medical Home Model must 
be at least:
     For QP Performance Period 2019, 3 percent of the APM 
Entity's total revenue under the payer.
     For QP Performance Period 2020, 4 percent of the APM 
Entity's total revenue under the payer.
     For QP Performance Period 2021 and later, 5 percent of the 
APM Entity's total revenue under the payer (82 FR 30182 through 30183).
    We sought comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Several commenters expressed support for this proposal.
    Response: We appreciate the commenters' support for this proposal.
    Comment: Some commenters suggested that the proposed total levels 
of revenue at risk are too high for Medicaid clinicians and should be 
lowered. One of these commenters recommended that ultimately 2.5 
percent of the APM Entity's total revenue under the payer should be at 
risk, not 5 percent as we have proposed. Another commenter suggested 
that states should have the ability and flexibility to set nominal risk 
levels.

[[Page 53851]]

    Response: We believe that we have taken into account the 
circumstances that eligible clinicians with a significant Medicaid 
practice face, particularly the potential that they may have limited 
experience with bearing financial risk, in the development of the 
Medicaid Medical Home Model nominal amount standard. We continue to 
believe that a gradual ramp-up to a 5 percent Medicaid Medical Home 
Model nominal amount standard is appropriate as eligible clinicians 
with a significant Medicaid practice may not have much experience in 
assuming risk. We also do not believe that this more gradual ramp-up 
will constrain state flexibility or discourage eligible clinicians from 
participating arrangements that we may determine are Medicaid Medical 
Home Models.
    Comment: One commenter stated that Medicaid Medical Home Models 
participating in a State Innovation Model (SIM) initiative should be 
exempt from the Medicaid Medical Home Model nominal amount standard.
    Response: Our determination of whether an other payer arrangement 
meets the Other Payer Advanced APM criteria, including the Medicaid 
Medical Home Model nominal amount standard, is based on whether the 
terms of the other payer arrangement itself meet the Other Payer 
Advanced APM criteria. While we appreciate and encourage continued and 
further participation in the State Innovation Model (SIM) initiative, 
that participation has no bearing on whether an other payer arrangement 
would be considered a Medicaid Medical Home Model.
    Final Action: After considering public comments, we are finalizing 
our proposal with one clarification. As we clarified in section 
II.D.4.c.(2)(a) of this final rule with comment period regarding the 
generally applicable revenue-based nominal amount standard, and as we 
state in the Medical Home Model nominal amount standard, we will look 
at the average estimated total Medicare Parts A and B revenue of 
providers and other entities participating in APM Entities. Similarly, 
for the Medicaid Medical Home Model nominal amount standard, we will 
look at the total revenues of the participating providers or other 
entities under the payment arrangement to determine whether an other 
payer arrangement meets the Medicaid Medical Home Model nominal amount 
standard.
    Therefore, we are amending Sec.  414.1420(d)(4)(i) and (iii) to 
state that meet the Medicaid Medical Home Model nominal amount 
standard, a Medicaid Medical Home Model must require that the total 
annual amount that an APM Entity potentially owes a payer or foregoes 
under the Medicaid Medical Home Model must be at least:
     For QP Performance Period 2019, 3 percent of the average 
estimated total revenue of the participating providers or other 
entities under the payer.
     For QP Performance Period 2020, 4 percent of the average 
estimated total revenue of the participating providers or other 
entities under the payer.
     For QP Performance Period 2021 and later, 5 percent of the 
average estimated total revenue of the participating providers or other 
entities under the payer.
(5) Summary of Final Policies
    In summary, we are finalizing the following policies:
     We are finalizing that an other payer arrangement would 
meet the generally applicable revenue-based nominal amount standard we 
are finalizing if, under the terms of the other payer arrangement, the 
total amount that an APM Entity potentially owes the payer or foregoes 
is equal to at least: For the 2019 and 2020 QP Performance Periods, 8 
percent of the total combined revenues from the payer to providers and 
other entities in the payment arrangement only for arrangements that 
are expressly defined in terms of revenue. We are codifying this policy 
by revising Sec.  414.1420(d)(3)(i).
     We are finalizing at Sec.  414.1420(d)(4)(i) and (iii) 
that a Medicaid Medical Home Model would meet the benchmark-based 
Medicaid Home Model nominal amount standard if, under the terms of the 
other payer arrangement, the total annual amount that an APM Entity 
potentially owes or foregoes under the Medicaid Medical Home Model must 
be at least:
    ++ For QP Performance Period 2019, 3 percent of the average 
estimated total revenue of the participating providers or other 
entities under the payer.
    ++ For QP Performance Period 2020, 4 percent of the average 
estimated total revenue of the participating providers or other 
entities under the payer.
    ++ For QP Performance Period 2021 and later, 5 percent of the 
average estimated total revenue of the participating providers or other 
entities under the payer.
c. Determination of Other Payer Advanced APMs
(1) Overview
    For other payer arrangements, in the CY 2017 Quality Payment 
Program final rule, we specified that an APM Entity or eligible 
clinician must submit, by a date and in a manner determined by us, 
information necessary to identify whether a given payment arrangement 
satisfies the Other Payer Advanced APM criteria (81 FR 77480). We 
finalized that we will identify Medicaid APMs and Medicaid Medical Home 
Models that meet the Other Payer Advanced APM criteria before the 
beginning of the QP Performance Period (81 FR 77478-77480). We also 
sought comment on the overall process for reviewing payment 
arrangements to determine whether they are Other Payer Advanced APMs, 
and we also sought comment on whether we should create a separate 
pathway to identify whether other payer arrangements with Medicaid as a 
payer meet the Other Payer Advanced APM criteria (81 FR 77463).
    We note that in the CY 2017 Quality Payment Program final rule, we 
codified some of our final policies pertaining to the Determination of 
Other Payer Advanced APMs at Sec.  414.1410(b)(2). In this CY 2018 
Quality Payment Program final rule with comment period, we are removing 
Sec.  414.1410(b)(2) and are codifying policies pertaining to Other 
Payer Advanced APM determinations at Sec.  414.144.
(a) Summary of Proposals
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
the following:
Payer Initiated Process
     We proposed to allow certain other payers, including 
payers with payment arrangements authorized under Title XIX, Medicare 
Health Plan payment arrangements, and payers with payment arrangements 
aligned with a CMS Multi-Payer Model to request that we determine 
whether their other payer arrangements are Other Payer Advanced APMs 
starting prior to the 2019 QP Performance Period and each year 
thereafter. We proposed to allow remaining other payers, including 
commercial and other private payers, to request that we determine 
whether other payer arrangements are Other Payer Advanced APMs starting 
in 2019 prior to the 2020 QP Performance Period, and annually each year 
thereafter. We proposed to generally refer to this process as the Payer 
Initiated Other Payer Advanced APM Determination Process (Payer 
Initiated Process), and we proposed that the Payer Initiated Process 
would generally involve the same steps for each payer type for each QP 
Performance Period. We proposed that these Other Payer Advanced APM 
determinations would be in effect for only one year at a time. We 
proposed

[[Page 53852]]

that the Payer Initiated Process would be voluntary for all payers.
     We proposed that payers would be required to use the Payer 
Initiated Submission Form to request that we make an Other Payer 
Advanced APM determination. We proposed that the Submission Period 
opening date and Submission Deadline would vary by payer type to align 
with existing CMS processes for payment arrangements authorized under 
Title XIX, Medicare Health Plan payment arrangements, and payers with 
payment arrangements aligned with a CMS Multi-Payer Model to the extent 
possible and appropriate.
     We proposed that if we determine that the payer has 
submitted incomplete or inadequate information, we would inform the 
payer and allow the payer to submit additional information no later 
than 10 business days from the date we inform the payer. For each other 
payer arrangement for which the payer does not submit sufficient 
information, we would not make a determination in response to that 
request submitted via the Payer Initiated Submission Form.
     We proposed that if a payer uses the same other payer 
arrangement in other commercial lines of business that the payer has 
submitted for determination as a Title XIX, Medicare Health Plan, or 
CMS Multi-Payer Model payment arrangement, we will allow the payer to 
concurrently request that we determine whether those other payer 
arrangements are Other Payer Advanced APMs as well.
     Title XIX (Medicaid): We proposed that any states and 
territories (``states'') that have in place a state plan under Title 
XIX may request that we determine prior to the QP Performance Period 
whether other payer arrangements authorized under Title XIX are Other 
Payer Advanced APMs under the Payer Initiated Process beginning in the 
year prior to the first QP Performance Period under the All-Payer 
Combination Option. We proposed to allow states to request 
determinations for both Medicaid fee-for-service and Medicaid managed 
care plan payment arrangements. We proposed that the Submission Period 
for the Payer Initiated Process would open on January 1 of the calendar 
year prior to the relevant QP Performance Period. We proposed that the 
Submission Deadline for these submissions is April 1 of the year prior 
to the QP Performance Period for which we would make the determination.
     CMS Multi-Payer Models: We proposed that payers with other 
payer arrangements aligned with a CMS Multi-Payer Model may request 
that we determine whether their aligned other payer arrangements are 
Other Payer Advanced APMs. We proposed that payers with other payer 
arrangements aligned with a CMS Multi-Payer Model may request that we 
determine prior to the QP Performance Period whether those other payer 
arrangements are Other Payer Advanced APMs. We proposed that payers 
that want to request that we determine whether those arrangements are 
Other Payer Advanced APMs would use the processes specified for payment 
arrangements authorized under Title XIX and Medicare Health Plan 
payment arrangements. We proposed that the Submission Period would open 
on January 1 of the calendar year prior to the relevant QP Performance 
Period. We also proposed that the Submission Period would close on June 
30 of the calendar year prior to the relevant QP Performance Period. We 
proposed that, in CMS Multi-Payer Models where a state prescribes 
uniform payment arrangements across all payers statewide, the state 
would submit on behalf of payers in the Payer Initiated Process for 
Other Payer Advanced APMs. We would seek information for the 
determination from the state, rather than individual payers. The same 
Payer Initiated Process and timeline described that applies for CMS 
Multi-Payer Models would apply.
     Medicare Health Plans: We proposed that the Submission 
Period would begin and end at the same time as the annual Medicare 
Advantage bid timeframe. We proposed the Submission Period would begin 
when the bid packages are sent out to plans in April of the year prior 
to the relevant QP Performance Period. We also proposed that the 
Submission Deadline would be the annual bid deadline, which would be 
the first Monday in June in the year prior to the relevant QP 
Performance Period.
     Remaining Other Payers: We proposed to allow the remaining 
other payers not specifically addressed in other proposals above, 
including commercial and other private payers that are not states, 
Medicare Health Plans, or payers with arrangements that are aligned 
with a CMS Multi-Payer Model, to request that we determine whether 
their other payer arrangements are Other Payer Advanced APMs starting 
prior to the QP Performance Period for 2020 and annually each year 
thereafter.
     We proposed that, for each other payer arrangement for 
which a payer requests us to determine whether it is an Other Payer 
Advanced APM, the payer must complete and submit the Payer Initiated 
Submission Form by the relevant Submission Deadline.
Eligible Clinician Initiated Process
     We proposed that through the Eligible Clinician Initiated 
Process, APM Entities and eligible clinicians participating in other 
payer arrangements would have an opportunity to request that we 
determine for the relevant QP Performance Period whether those other 
payer arrangements are Other Payer Advanced APMs. The Eligible 
Clinician Initiated Process could also be used to request 
determinations before the beginning of a QP Performance Period for 
other payer arrangements authorized under Title XIX.
     We proposed that APM Entities or eligible clinicians would 
be required to use the Eligible Clinician Initiated Submission Form to 
request that we make an Other Payer Advanced APM determination.
     We proposed that if we determine that an APM Entity or 
eligible clinician has submitted incomplete or inadequate information, 
we would inform the payer and allow the payer to submit additional 
information no later than 10 business days from the date we inform the 
APM Entity or eligible clinician. For each other payer arrangement for 
which the APM Entity or eligible clinician does not submit sufficient 
information, we would not make a determination in response to that 
request submitted via the Eligible Clinician Initiated Submission Form.
     Title XIX (Medicaid): We proposed that beginning in the 
first QP Performance Period under the All-Payer Combination Option, APM 
Entities and eligible clinicians may submit information on payment 
arrangements authorized under Title XIX to request that we determine 
whether those arrangements that are not already determined to be Other 
Payer Advanced APMs through the Payer Initiated Process are Medicaid 
APMs or Medicaid Medical Home Models that meet the Other Payer Advanced 
APM criteria prior to the QP Performance Period. We proposed that APM 
Entities or eligible clinicians may submit Eligible Clinician Initiated 
Submission Forms for payment arrangements authorized under Title XIX 
beginning on September 1 of the calendar year prior to the QP 
Performance Period. We also proposed that the Submission Deadline is 
November 1 of the calendar year prior to the QP Performance Period.
     CMS Multi-Payer Models: We proposed that through the 
Eligible Clinician Initiated Process, APM Entities and eligible 
clinicians

[[Page 53853]]

participating in other payer arrangements in CMS Multi-Payer Models may 
request that we determine whether those other payer arrangements that 
are not already determined to be Other Payer Advanced APMs through the 
Payer Initiated Process are Other Payer Advanced APMs. We proposed that 
APM Entities or eligible clinicians may request Other Payer Advanced 
APM determinations beginning on August 1 of the same year as the 
relevant QP Performance Period. We proposed that the Submission 
Deadline for requesting Other Payer Advanced APM determinations, as 
well as to request QP determinations under the All-Payer Combination 
Option, is December 1 of the same year as the relevant QP Performance 
Period.
     Medicare Health Plans: We proposed that through the 
Eligible Clinician Initiated Process, APM Entities and eligible 
clinicians participating in other payer arrangements in Medicare Health 
Plans would have an opportunity to request that we determine whether 
those other payer arrangements that are not already determined to be 
Other Payer Advanced APMs through the Payer Initiated Process are Other 
Payer Advanced APMs. We proposed that APM Entities or eligible 
clinicians may request Other Payer Advanced APM determinations 
beginning on August 1 of the same year as the relevant QP Performance 
Period. We proposed that the Submission Deadline for requesting Other 
Payer Advanced APM determinations, as well as to request QP 
determinations under the All-Payer Combination Option, is December 1 of 
the same year as the relevant QP Performance Period.
     Remaining Other Payers: We proposed that, through the 
Eligible Clinician Initiated Process, APM Entities and eligible 
clinicians participating in other payer arrangements through a 
remaining other payer may request that we determine whether or not the 
payment arrangement is an Other Payer Advanced APM. We proposed that 
APM Entities or eligible clinicians may request Other Payer Advanced 
APM determinations beginning on August 1 of the same year as the 
relevant QP Performance Period. We proposed that the Submission 
Deadline for requesting Other Payer Advanced APM determinations, as 
well as to request QP determinations under the All-Payer Combination 
Option, is December 1 of the same year as the relevant QP Performance 
Period.
Submission of Information for Other Payer Advanced APM Determinations
     We proposed that, for each other payer arrangement for 
which a payer requests us to determine whether it is an Other Payer 
Advanced APM, all payers must complete and submit the Payer Initiated 
Submission Form by the relevant Submission Deadline. We proposed that 
the Payer Initiated Submission Form would allow payers to include 
descriptive language for each of the required information elements. We 
proposed to require the name and description of the arrangement, nature 
of the arrangement, QP Performance Period for which the arrangement is 
available, participant eligibility criteria, and location(s) where the 
arrangement will be available so that we can verify whether eligible 
clinicians who may tell us that they participate in such arrangements 
are eligible to do so. We proposed to require that payers submit 
documentation that supports the information they provided in the Payer 
Initiated Submission Form and that is sufficient to enable us to 
determine whether the other payer arrangement is an Other Payer 
Advanced APM.
     We proposed that, for each other payer arrangement for 
which an APM Entity or eligible clinician requests us to determine 
whether it is an Other Payer Advanced APM, all eligible clinicians must 
complete and submit the Eligible Clinician Initiated Submission Form by 
the relevant Submission Deadline. We proposed that the Eligible 
Clinician Initiated Submission Form would allow APM Entities or 
eligible clinicians to include descriptive language for each of the 
required information elements. We proposed to require the name and 
description of the arrangement, nature of the arrangement, QP 
Performance Period for which the arrangement is available, participant 
eligibility criteria, and location(s) where the arrangement will be 
available so that we can verify whether eligible clinicians who may 
tell us that they participate in such arrangements are eligible to do 
so. We proposed to require that APM Entities or eligible clinicians 
submit documentation that supports the information they provided in the 
Eligible Clinician Initiated Submission Form and that is sufficient to 
enable us to determine whether the other payer arrangement is an Other 
Payer Advanced APM.
     We proposed that, for each other payer arrangement for 
which an APM Entity or eligible clinician requests us to determine 
whether it is an Other Payer Advanced APM, the APM Entity or eligible 
clinician must complete and submit the Eligible Clinician Initiated 
Submission Form by the relevant Submission Deadline.
     We proposed to add a new requirement at Sec.  414.1445(d) 
stating that a payer that submits information pursuant to Sec.  
414.1445(c) must certify to the best of its knowledge that the 
information submitted to us through the Payer Initiated Process is 
true, accurate, and complete. Additionally, we proposed that this 
certification must accompany the Payer Initiated Submission Form and 
any supporting documentation that payers submit to us through the Payer 
Initiated Process.
     We also proposed to revise the monitoring and program 
integrity provisions at Sec.  414.1460 to ensure the integrity of the 
Payer Initiated Process. Specifically, we proposed to require payers 
that choose to submit information through the Payer Initiated Process 
to maintain such books, contracts, records, documents, and other 
evidence as necessary to audit an Other Payer Advanced APM 
determination, and that such information and supporting documentation 
must be maintained for 10 years after submission and must be provided 
to CMS upon request. We also proposed to specify that information 
submitted by payers for purposes of the All-Payer Combination Option 
may be subject to audit by CMS.
     We proposed to remove the requirement at Sec.  
414.1445(b)(3) that payers must attest to the accuracy of information 
submitted by eligible clinicians. We also proposed to remove the 
attestation requirement at Sec.  414.1460(c) and add a requirement at 
Sec.  414.1445(d) that an APM Entity or eligible clinician that submits 
information pursuant to Sec.  414.1445(c) must certify to the best of 
its knowledge that the information it submitted to us is true, 
accurate, and complete. We also proposed that this certification must 
accompany the submission.
     We proposed to remove the record retention requirement at 
Sec.  414.1445(c) and only address the record retention issue at Sec.  
414.1460(e) stating that APM Entities and eligible clinicians must 
maintain such books, contracts, records, documents, and other evidence 
as necessary to enable the audit of an Other Payer Advanced APM 
determination, QP determination, and the accuracy of an APM Incentive 
Payment.
     We proposed that, with the exception of the specific 
information we proposed to make publicly available as stated above, the 
information a payer submits to us through the Payer Initiated Process 
and the information an APM Entity or eligible clinician submits

[[Page 53854]]

to us through the Eligible Clinician Initiated Process would be kept 
confidential to the extent permitted by federal law, in order to avoid 
dissemination of potentially sensitive contractual information or trade 
secrets.
     We proposed that we would presume that an other payer 
arrangement would satisfy the 50 percent CEHRT use criterion if we 
receive information and documentation from the APM Entity or eligible 
clinician through the Eligible Clinician Initiated Process showing that 
the other payer arrangement requires the requesting eligible 
clinician(s) to use CEHRT to document and communicate clinical 
information.
(b) Payer Initiated Other Payer Advanced APM Determination Process 
(Payer Initiated Process)
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
to allow certain other payers, including payers with payment 
arrangements authorized under Title XIX, Medicare Health Plan payment 
arrangements, and payers with payment arrangements aligned with a CMS 
Multi-Payer Model to request that we determine whether their other 
payer arrangements are Other Payer Advanced APMs starting prior to the 
2019 QP Performance Period and each year thereafter. We proposed to 
generally refer to this process as the Payer Initiated Other Payer 
Advanced APM Determination Process (Payer Initiated Process) (82 FR 
30183).
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters supported CMS's proposed general 
approach for Other Payer Advanced APM determinations, and many 
commenters supported our proposed general approach to the Payer 
Initiated Process.
    Response: We appreciate the support for our proposed general 
approach for Other Payer Advanced APM determinations and the Payer 
Initiated Process.
    Comment: Some commenters stated that CMS's general proposed 
approach is overly complicated and requested that CMS simplify how it 
makes Other Payer Advanced APM determinations.
    Response: One of our goals is to minimize the burden on payers, APM 
Entities, and eligible clinicians to the extent possible while 
collecting the information that we need in order to make Other Payer 
Advanced APM determinations. As we continue to implement the All-Payer 
Combination Option, we will continue to evaluate and adjust policies if 
there are additional opportunities to reduce burden that we can 
incorporate into how we determine whether other payer arrangements meet 
the Other Payer Advanced APM criteria.
    Comment: Two commenters opposed the proposed Payer Initiated 
Process. These commenters stated that group practices and eligible 
clinicians should be responsible for submitting payment arrangement 
information, not payers. One commenter stated that this process is 
confusing.
    Response: We note that the Payer Initiated Process is voluntary. 
Payers who do not wish to submit information through the Payer 
Initiated Process are not required to do so. APM Entities and eligible 
clinicians can choose to submit payment information on those same other 
payer arrangements through the Eligible Clinician Initiated Process. We 
believe that offering payers the option to submit payment arrangement 
information can help with the implementation of the All-Payer 
Combination Option, including by reducing some of the burden for APM 
Entities and eligible clinicians. We reiterate that one of our goals is 
to reduce burden and complexity, and we will continue to look for 
opportunities to further streamline this process.
    Comment: One commenter supported the overall approach of the Payer 
Initiated Process, but the commenter suggested that CMS consider 
simplifying the process significantly by requiring payers to submit 
their arrangements to us at the group (TIN) level.
    Response: We will rely on payers to tell us how the payment 
arrangement is designed and who is eligible to participate, and we 
believe we have allowed for significant flexibility in this decision, 
which we think is particularly important given the likely variation in 
the structure of payment arrangements for which payers may request 
Other Payer Advanced APM determinations.
    Final Action: After considering public comments, we are finalizing 
our proposals to allow certain other payers, including payers with 
payment arrangements authorized under Title XIX, Medicare Health Plan 
payment arrangements, and payers with payment arrangements aligned with 
a CMS Multi-Payer Model to request that we determine whether their 
other payer arrangements are Other Payer Advanced APMs starting prior 
to the 2019 QP Performance Period and each year thereafter. We will 
generally refer to this process as the Payer Initiated Other Payer 
Advanced APM Determination Process (Payer Initiated Process). We are 
codifying these policies at Sec. Sec.  414.1445(a) and 414.1445(b)(1).
    In the CY 2018 Quality Payment Program proposed rule, if a payer 
requests that we determine whether a payment arrangement authorized 
under Title XIX, a Medicare Health Plan payment arrangement, or a 
payment arrangement in a CMS Multi-Payer Model is an Other Payer 
Advanced APM, and the payer uses the same other payer arrangement in 
other commercial lines of business, we proposed to allow the payer to 
concurrently request that we determine whether those other payer 
arrangements are Other Payer Advanced APMs as well. We proposed to make 
Other Payer Advanced APM determinations for each individual payment 
arrangement (82 FR 30183). We sought comment on this proposal. The 
following is a summary of the public comments received on this proposal 
and our responses:
    Comment: One commenter suggested that if a payer has the same 
payment arrangement in place across multiple plans, that payer should 
be allowed to submit one form for a determination that would apply to 
all of those plans.
    Response: We appreciate the suggestion. We will continue to 
identify ways where we can simplify the Payer Initiated Process, and we 
will provide further detailed instructions and guidance on how to 
complete the Payer Initiated Submission Form. It is our intent that if 
a payer has the same payment arrangement in place across multiple 
plans, or multiple payer types, that payer should be allowed to submit 
one Payer Initiated Submission Form for a determination that will apply 
to all of those plans or payer types.
    Final Action: After considering public comments, we are finalizing 
this policy as proposed with one modification. We are finalizing that 
we will allow payers with payment arrangements under Title XIX or 
aligned with a CMS Multi-Payer Model to submit a single submission form 
when the same payment arrangement is in place with other plans. 
However, we are not currently extending this policy to Medicare Health 
Plans as we continue to address the feasibility of operational changes 
to the Health Plan Management System (HPMS) that would be necessary to 
implement this policy.
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that these Other Payer Advanced APM determinations would be in effect 
for only one year at a time (82 FR 30183).
    We sought comment on this proposal. The following is a summary of 
the public comments received on this proposal and our responses:

[[Page 53855]]

    Comment: Many commenters expressed concern with an annual 
determination process and generally preferred a policy where Other 
Payer Advanced APM determinations would be in effect for multiple 
years. Some of these commenters requested a multi-year policy 
specifically for Medicaid payment arrangements. Some commenters stated 
that some of these arrangements take years to develop and that they 
last for more than one year, and some commenters recommended that we 
renew Other Payer Advanced APM determinations automatically if either 
the payer or eligible clinician attests that the key characteristics of 
the Other Payer Advanced APM are not changing from year to year. Some 
commenters were concerned that an annual determination process would 
introduce an unnecessary element of uncertainty to eligible clinicians, 
particularly those in Other Payer Advanced APMs that have an agreement 
term of more than one year. Several commenters suggested that CMS 
establish a multi-year process, such as a 3 or 5 year process, so that 
an Other Payer Advanced APM determination would remain valid throughout 
that period and that payers only need to report changes as they occur. 
These commenters suggested that these alternatives would reduce burden 
and also encourage the development of multi-year Other Payer Advanced 
APMs.
    Response: We will start out for the first year of Other Payer 
Advanced APM determinations with an annual submission and determination 
process, and then evaluate whether there is an appropriate, less 
burdensome, and administratively feasible way to extend determinations 
for subsequent years. We believe it is necessary to obtain more 
information on the characteristics of, and more experience with, other 
payer arrangements and the determination process before we change our 
approach. We are also interested in what impact multiple year 
determinations might have on payers, for example, would it encourage 
payers to develop multi-year payment arrangements.
    Final Action: After considering public comments, we are finalizing 
this policy as proposed. We seek comment regarding the current duration 
of the contracts governing such arrangements and whether creating some 
multi-year determination would encourage the creation of more multi-
year payment arrangements as opposed to payment arrangements that are 
one year. We also seek comment on what kind of information should be 
submitted annually to update an Other Payer Advanced APM determination. 
We will consider in future rulemaking whether to introduce an option 
where Other Payer Advanced APM determinations could be extended for 
more than one year a time in future rulemaking.
    We also proposed to allow remaining other payers, including 
commercial and other private payers, to request that we determine 
whether other payer arrangements are Other Payer Advanced APMs starting 
in 2019 prior to the 2020 QP Performance Period and annually each year 
thereafter. In the CY 2018 Quality Payment Program proposed rule, we 
stated that we believe that phasing in the Payer Initiated Process 
would allow us to gain experience with the determination process on a 
limited basis with payers where we have the strongest relationships and 
existing processes that we believe can help facilitate submitting this 
information, and that we anticipated making improvements and 
refinements to this process, which we believe will help us facilitate 
receiving this information from the remaining other payers (82 FR 
30183). We refer readers to section II.D.6.c.(5)(a) of this final rule 
with comment period for a discussion of these policies.
    We proposed that the Payer Initiated Process would be voluntary for 
all payers.
    We sought comment on this proposal. We did not receive any comments 
in response to this proposal.
    Final Action: We are finalizing that the Payer Initiated Process 
will be voluntary for all payers.
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that the Payer Initiated Process would generally involve the same steps 
for each payer type as listed below for each QP Performance Period, and 
we elaborated on details within this framework that are specific to 
payer type (82 FR 30183 through 30184). We discuss our final policies 
below.
    Guidance and Submission Form: We noted that we intend to make 
guidance available regarding the Payer Initiated Process for each payer 
type prior to the first Submission Period, which would occur during 
2018. We also noted that we intend to develop a submission form (which 
we refer to as the Payer Initiated Submission Form) that would be used 
by payers to request Other Payer Advanced APM determinations, and that 
we intend to make this Payer Initiated Submission Form available to 
payers prior to the first Submission Period. We proposed that payers 
would be required to use the Payer Initiated Submission Form to request 
that we make an Other Payer Advanced APM determination. We stated that 
we intend for the Payer Initiated Submission Form to include questions 
that are applicable to all payment arrangements and some that are 
specific to a particular type of payment arrangement, and we intend for 
it to include a way for payers to attach supporting documentation. We 
proposed that payers may submit requests for review of multiple other 
payer arrangements through the Payer Initiated Process, though we would 
make separate determinations as to each other payer arrangement and a 
payer would be required to use a separate Payer Initiated Submission 
Form for each other payer arrangement. Payers may submit other payer 
arrangements with different tracks within that arrangement as one 
request along with information specific to each track.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters requested that submission forms and 
guidance be made available for payers and eligible clinicians as soon 
as possible, potentially earlier than the beginning of calendar year or 
in the case of Medicare Health Plans, before the bid process. These 
commenters stated that making the forms and guidance available earlier 
would give payers more lead time to prepare and submit the necessary 
information.
    Response: We agree that it is important to make the Payer Initiated 
Submission Form and related guidance available as soon as possible so 
that payers have time to prepare and submit the information and we 
intend to do so. We note that the Payer Initiated Submission Form is 
subject to the Paperwork Reduction Act (PRA) approval process, which 
includes an opportunity for public comment. We refer readers to section 
IV.O. of this final rule with comment period for more information about 
that process. After the first year, if any updates or amendments are 
necessary, we also intend to make those available as soon as possible.
    Comment: One commenter suggested that CMS should use the Quality 
Reporting Document Architecture (QRDA) III as the submission content 
standard because it is already an industry standard, and the commenter 
also suggested that CMS should align their work with industry standards 
to avoid increasing physician burden by introducing proprietary formats 
that differ from what is used for submission to other payers or state 
Medicaid programs. The commenter also noted that HHS has already 
required industry-wide investment in QRDA III through their ONC 
certification program, so

[[Page 53856]]

using QRDA III would facilitate implementation.
    Response: We appreciate the suggestion and will consider these 
ideas as we continue to develop and refine the Submission Form.
    Final Action: After considering public comments, we are finalizing 
our proposal that payers with payment arrangements authorized under 
Title XIX, Medicare Health Plan payment arrangements, and payment 
arrangements aligned with a CMS Multi-Payer Model will be required to 
use the Payer Initiated Submission Form in order to request that we 
make an Other Payer Advanced APM determination. We are also finalizing 
our proposal that payers may submit requests for review of multiple 
other payer arrangements through the Payer Initiated Process, though we 
will make separate determinations as to each other payer arrangement, 
and a payer will be required to use a separate Payer Initiated 
Submission Form for each other payer arrangement.
    Submission Period: We proposed that the Submission Period opening 
date and Submission Deadline would vary by payer type to align with 
existing CMS processes for payment arrangements authorized under Title 
XIX, Medicare Health Plan payment arrangements, and payers with payment 
arrangements aligned with a CMS Multi-Payer Model to the extent 
possible and appropriate.
    We sought comment on this proposal. The following is a summary of 
the comments received on this proposal and our responses:
    Comment: A few commenters supported CMS's proposed general approach 
and efforts to align with existing programs.
    Response: We appreciate the commenters' support of our proposed 
general approach.
    Comment: Some commenters requested that CMS create a rolling 
determination process where Payer Initiated Submission Forms could be 
submitted at any time.
    Response: We believe that it is important for both payers and us, 
particularly in the first year of implementing the Payer Initiated 
Process, to have a clear structure for the Payer Initiated Process that 
can be easily understood. We reiterate that our goal is to align with 
existing CMS processes and deadlines to the extent possible. We also 
believe that the deadlines are important so that we can timely generate 
and publish the list of Other Payer Advanced APMs on the CMS Web site. 
We may consider making changes to our overall approach to the 
Submission Periods when we have more experience in operating the Payer 
Initiated Process.
    Comment: One commenter suggested that payers submitting information 
for Other Payer Advanced APM determinations should be required to 
notify their APM Entities and eligible clinicians that they are 
submitting information, which would help reduce burden on APM Entities 
and eligible clinicians and avoid duplicate submissions.
    Response: While we would generally encourage this type of 
communication, we do not believe that we should set requirements for 
how payers interact with APM Entities and eligible clinicians in their 
payment arrangements, and we note that payers can choose to notify 
their participating APM Entities and eligible clinicians either that 
they submitted information to request an Other Payer Advanced APM 
determination, as well as the determination that the payers receive. We 
also note that the public posting of Other Payer Advanced APMs on the 
CMS Web site may reduce duplicative submissions by APM Entities or 
eligible clinicians.
    Comment: One commenter suggested that CMS make public all other 
payer arrangements that are under review prior to the determination of 
whether they are Other Payer Advanced APMs, so that APM Entities and 
eligible clinicians are aware the review is taking place.
    Response: While we appreciate the suggestion, we believe that 
making this information public would do more to confuse APM Entities 
and eligible clinicians, especially as we already intend to post a list 
of Other Payer Advanced APMs on the CMS Web site. Also, we anticipate 
that all determinations under the Payer Initiated Process will be made 
prior to the relevant QP Performance Period. We reiterate that the 
Eligible Clinician Initiated Process takes place after the conclusion 
of the QP Performance Period. For this reason, we believe that there 
would be limited, if any, utility to posting a list of other payer 
arrangements for which there are pending Other Payer Advanced APM 
determinations because we will have already posted a list of the 
payment arrangements determined to be Other Payer Advanced APMs on the 
CMS Web site prior to the start of the relevant QP Performance Period.
    Final Action: After considering public comments, we are finalizing 
our proposal that the Submission Period opening date and Submission 
Deadline would vary by payer type to align with existing CMS processes 
for payment arrangements authorized under Title XIX, Medicare Health 
Plan payment arrangements, and payers with payment arrangements aligned 
with a CMS Multi-Payer Model to the extent possible and appropriate. We 
discuss the specific Submission Period for each payer type in sections 
II.D.6.c.(2)(a), II.D.6.c.(3)(a), and II.D.6.c.(4)(a) of this final 
rule with comment period.
    CMS Determination: Upon the timely receipt of a Payer Initiated 
Submission Form, we would use the information submitted to determine 
whether the other payer arrangement meets the Other Payer Advanced APM 
criteria. We proposed that if we find that the payer has submitted 
incomplete or inadequate information, we would inform the payer and 
allow the payer to submit additional information no later than 10 
business days from the date we inform the payer. For each other payer 
arrangement for which the payer does not submit sufficient information 
in a timely fashion, we would not make a determination in response to 
that request submitted via the Payer Initiated Submission Form. As a 
result, the other payer arrangement would not be considered an Other 
Payer Advanced APM for the year. These determinations are final and not 
subject to reconsideration.
    We sought comment on this proposal. The following is a summary of 
the public comments received on this proposal and our responses:
    Comment: Several commenters opposed the 10 business day limit for 
responding to a request for additional information, noting that 10 
business days is too short a timeframe to adequately address such 
requests.
    Response: We believe that responding to requests for additional 
information will generally be a straightforward process, and that the 
process and timeline for these requests will allow us to verify 
information while making determinations in an expeditious manner. At 
the same time, we recognize that payers may need some additional time 
to respond to requests.
    Comment: Some commenters objected that determinations are final and 
not subject to reconsideration. Some commenters were concerned that 
there may be instances where we do not appropriately consider the 
information submitted. These commenters requested that determinations 
be reconsidered at least once and that a formal appeals process be 
installed, and one of these commenters suggested that CMS should allow 
such appeals to be submitted within 30 days of the determination.
    Response: We appreciate the comment. We continue to believe that it

[[Page 53857]]

is appropriate for us to make final Other Payer Advanced APM 
determinations. We are considering whether it would be beneficial to 
provide for an informal review process, and we may address this issue 
in future rulemaking.
    Comment: A few commenters requested that CMS to commit to specific 
timeframes for making Other Payer Advanced APM determinations.
    Response: We are trying to provide as much certainty and notice in 
the Payer Initiated Process as possible especially because this coming 
year will be the first year where we implement the Payer Initiated 
Process. We note that we are committed to making Other Payer Advanced 
APM determinations as soon as practicable.
    Final Action: After considering public comments, we are finalizing 
a modified version of the proposed policy. We will extend the required 
timeframe for responding to a request for additional information from 
10 days to 15 business days in order to provide payers more time to 
respond while still allowing for Other Payer Advanced APM 
determinations to be made expeditiously. We are finalizing this policy 
for the determination process for payment arrangements authorized under 
Title XIX, Medicare Health Plan payment arrangements, and payment 
arrangements aligned with a CMS Multi-Payer Model.
    CMS Notification: We noted that we intend to notify payers of our 
determination for each request as soon as practicable after the 
relevant Submission Deadline. APM Entities or eligible clinicians may 
submit information regarding an other payer arrangement for a 
subsequent QP Performance Period even if we have determined that the 
other payer arrangement is not an Other Payer Advanced APM for a prior 
year.
    The following is a summary of the public comments received on this 
topic and our responses:
    Comment: One commenter sought clarification regarding when we would 
notify payers of the results of Other Payer Advanced APM 
determinations.
    Response: We reiterate that we intend to notify payers of the 
results as soon as practicable and clarify that this notification to 
payers is independent of posting the list of Other Payer Advanced APMs 
on the CMS Web site.
    Final Action: After considering public comments, we reiterate that 
we intend to notify payers of our determination for each request under 
the Payer Initiated Process as soon as practicable after the relevant 
Submission Deadline. We codify this policy at Sec.  414.1445(f).
    CMS Posting of Other Payer Advanced APMs: We noted that we intend 
to post on the CMS Web site a list (which we refer to as the Other 
Payer Advanced APM List) of all other payer arrangements that we 
determine to be Other Payer Advanced APMs. Prior to the start of the 
relevant QP Performance Period, we intend to post the Other Payer 
Advanced APMs that we determine through the Payer Initiated Process and 
Other Payer Advanced APMs under Title XIX that we determine through the 
Eligible Clinician Initiated Process. After the QP Performance Period, 
we would update this list to include Other Payer Advanced APMs that we 
determine based on other requests through the Eligible Clinician 
Initiated Process.
    We still intend to post this list prior to the start of the 
relevant QP Performance Period and then update it to include Other 
Payer Advanced APMs that we determine based on requests received 
through the Eligible Clinician Initiated Process.
(c) APM Entity or Eligible Clinician Initiated Other Payer Advanced APM 
Determination Process (Eligible Clinician Initiated Process)
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that through the Eligible Clinician Initiated Process, APM Entities and 
eligible clinicians participating in other payer arrangements would 
have an opportunity to request that we determine for the year whether 
those other payer arrangements are Other Payer Advanced APMs. The 
Eligible Clinician Initiated Process could also be used to request 
determinations before the beginning of a QP Performance Period for 
other payer arrangements authorized under Title XIX. The Eligible 
Clinician Initiated Process would not be necessary for, or applicable 
to, other payer arrangements that are already determined to be Other 
Payer Advanced APMs through the Payer Initiated Process (82 FR 30184).
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Some commenters expressed support for our proposed general 
approach to the Eligible Clinician Initiated Process.
    Response: We appreciate commenters' support of this proposed 
general approach to the Eligible Clinician Initiated Process.
    Comment: One commenter stated that the proposed Eligible Clinician 
Initiated Process presents operational challenges to eligible 
clinicians, particularly that reporting the information would be time 
consuming and burdensome. Another commenter stated that ultimately the 
onus for submitting information on payment arrangements should be with 
payers as they have all the relevant information and relying on 
eligible clinicians to submit information would result in duplication.
    Response: We do not have the authority to require payers to submit 
information regarding their payment arrangements. Therefore, we believe 
it is important for an option to be available for eligible clinicians 
or APM Entities to submit such information. If an eligible clinician 
requests a QP determination under the All-Payer Combination Option, the 
eligible clinician or APM Entity has the opportunity to submit 
information to allow us to determine whether an other payer arrangement 
is an Other Payer Advanced APM. Our goal is to minimize the burden 
associated with the Eligible Clinician Initiated Process. We also note 
that payers may voluntarily submit other payer arrangement information 
through the Payer Initiated Process so that we can determine whether 
those arrangements are Other Payer Advanced APMs, which may reduce or 
eliminate the need for some APM Entities or eligible clinicians to 
submit information through the Eligible Clinician Initiated Process.
    Comment: One commenter suggested that Other Payer Advanced APM 
determinations made through the Eligible Clinician Initiated Process be 
made for multiple years if the contracts involved are for multiple 
years.
    Response: As we stated regarding the Payer Initiated Process above, 
we will start out for the first year with an annual submission and 
determination process and then evaluate next year whether there is an 
appropriate, less burdensome, and administratively feasible way to 
extend determinations for subsequent years. We believe it is necessary 
to get more information on the characteristics of, and more experience 
with, other payer arrangements and the determination process before we 
change our approach.
    Final Action: After considering public comments, we are finalizing 
our proposal that through the Eligible Clinician Initiated Process, APM 
Entities and eligible clinicians participating in other payer 
arrangements would have an opportunity to request that we determine for 
the year whether those other payer arrangements are Other Payer 
Advanced APMs. We seek additional comment regarding the current 
duration of payment arrangements and whether creating a

[[Page 53858]]

multi-year determination process would encourage the creation of more 
multi-year payment arrangements as opposed to payment arrangements that 
are one year. We also seek comment on what kind of information should 
be submitted annually after the first year to update an Other Payer 
Advanced APM determination. We will consider in future rulemaking 
whether to introduce an option where Other Payer Advanced APM 
determinations could be last for more than one year a time.
    Guidance and Submission Form: We intend to make guidance available 
regarding the Eligible Clinician Initiated Process for each payer type 
prior to the first Submission Period for arrangements authorized under 
Title XIX, which would occur during 2018. We intend to develop a 
submission form (which we refer to as the Eligible Clinician Initiated 
Submission Form) that will be used by APM Entities or eligible 
clinicians to request Other Payer Advanced APM determinations, and we 
intend to make this Eligible Clinician Initiated Submission Form 
available to APM Entities and eligible clinicians prior to the first 
Submission Period. We proposed that APM Entities and eligible 
clinicians would be required to use the Eligible Clinician Initiated 
Submission Form to request that we make an Other Payer Advanced APM 
determination. We intend for the Eligible Clinician Initiated 
Submission Form to include questions that are applicable to all other 
payer arrangements and some that are specific to a particular type of 
other payer arrangements, and we intend for it to include a way for APM 
Entities or eligible clinicians to attach supporting documentation. We 
proposed that APM Entities or eligible clinicians may submit requests 
for review of multiple other payer arrangements through the Eligible 
Clinician Initiated Process, though we would make separate 
determinations as to each other payer arrangement, and an APM Entity or 
eligible clinician would be required to use a separate Eligible 
Clinician Initiated Submission Form for each other payer arrangement. 
APM Entities or eligible clinicians may submit other payer arrangements 
with different tracks within that arrangement as one request along with 
information specific to each track.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter suggested that CMS clarify that only APM 
Entities or eligible clinicians that hold contracts with an other payer 
should submit an Eligible Clinician Initiated Submission Form for an 
Other Payer Advanced APM determination.
    Response: We agree with this commenter and we clarify here that 
only APM Entities or eligible clinicians that hold contracts to 
participate in an payment arrangement with an other payer can submit an 
Eligible Clinician Initiated Submission Form for an Other Payer 
Advanced APM determination. We will make this limitation clear in 
guidance and instructions for the Eligible Clinician Initiated 
Submission Form.
    Final Action: After considering public comments, we are finalizing 
our proposal that APM Entities and eligible clinicians would be 
required to use the Eligible Clinician Initiated Submission Form to 
request that we make an Other Payer Advanced APM determination. We are 
also finalizing our proposal that APM Entities or eligible clinicians 
may submit requests for review of multiple other payer arrangements 
through the Eligible Clinician Initiated Process, though we will make 
separate determinations as to each other payer arrangement, and an APM 
Entity or eligible clinician will be required to use a separate 
Eligible Clinician Initiated Submission Form for each other payer 
arrangement. We are finalizing this policy for all of the Eligible 
Clinician Initiated Process regardless of the type of payment 
arrangement being submitted.
    Submission Period: In general, we proposed that APM Entities or 
eligible clinicians may request Other Payer Advanced APM determinations 
beginning on August 1 of the same year as the relevant QP Performance 
Period. We proposed that the Submission Deadline for requesting Other 
Payer Advanced APM determinations, as well as to request QP 
determinations under the All-Payer Combination Option, is December 1 of 
the same year as the relevant QP Performance Period.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: A few commenters were concerned that having a Submission 
Deadline would be burdensome to APM Entities and eligible clinicians, 
and they suggested that CMS institute a rolling process without a set 
deadline would provide additional flexibility.
    Response: We believe that it is important for eligible clinicians, 
APM Entities, and us, particularly in the first year of implementing 
the Eligible Clinician Initiated Process, to have a clear structure for 
the Eligible Clinician Initiated Process that can be easily understood. 
We may consider making changes to the overall approach to Submission 
Periods when we have more information and experience with the Eligible 
Clinician Initiated Process. We are also concerned that a rolling 
process where we receive requests to make Other Payer Advanced APM 
determinations after December 1 could delay QP determinations; and 
timely QP determinations are important so that eligible clinicians can 
make other important and time sensitive decisions if necessary, such as 
preparing for MIPS reporting.
    Comment: One commenter requested clarification regarding why some 
eligible clinicians are required to submit information prior to the QP 
Performance Period and others are allowed to submit information after 
the QP Performance Period.
    Response: We clarify that the only category of payment arrangements 
where APM Entities or eligible clinicians must submit information prior 
to the QP Performance Period is for Medicaid payment arrangements, and 
as we discuss in section II.D.6.c.(2)(a) of this final rule with 
comment period, we allow this early submission so that we can carry out 
the required exclusion of Title XIX payments and patients from the 
other payer portion of certain QP determination calculations under the 
All-Payer Combination Option. For other payer arrangements for which 
Medicaid is not the payer, APM Entities or eligible clinicians can 
submit requests for determinations of Other Payer Advanced APMs after 
the QP Performance Period. We note that the distinction is based on the 
type of payment arrangement, not the type of APM Entity or eligible 
clinician. An APM Entity could be in a Medicaid payment arrangement and 
also a payment arrangement with a commercial payer, and the APM Entity 
may request Other Payer Advanced APM determinations for both 
arrangements. To request an Other Payer Advanced APM determination for 
the Medicaid payment arrangement, the APM Entity would submit the 
Eligible Clinician Initiated Submission Form prior to the QP 
Performance Period. That same APM Entity would submit the Eligible 
Clinician Initiated Submission Form after the QP Performance Period, 
but before December 1, for the arrangement with the commercial payer.
    Final Action: After considering public comments, we are finalizing 
our proposal that APM Entities or eligible clinicians may request Other 
Payer Advanced APM determinations beginning on August 1 of the same 
year as the relevant QP Performance Period

[[Page 53859]]

for payment arrangements authorized under Title XIX. We note that 
eligible clinicians may request Other Payer Advanced APM determinations 
for payment arrangements authorized under Title XIX prior to the 
relevant QP Performance Period, beginning in 2018. We are also 
finalizing our proposal that the Submission Deadline for requesting 
Other Payer Advanced APM determinations, as well as to request QP 
determinations under the All-Payer Combination Option, is December 1 of 
the same year as the relevant QP Performance Period.
    CMS Determination: Upon timely receipt of an Eligible Clinician 
Initiated Submission Form, we would use the information submitted to 
determine whether the other payer arrangement meets the Other Payer 
Advanced APM criteria. We proposed that, if we determine that the APM 
Entity or eligible clinician has submitted incomplete or inadequate 
information, we would inform the APM Entity or eligible clinician and 
allow the APM Entity or eligible clinician to submit additional 
information no later than 10 business days from the date we inform the 
APM Entity or eligible clinician. For each other payer arrangement for 
which the APM Entity or eligible clinician does not submit sufficient 
information, we would not make a determination in response to that 
request submitted via the Eligible Clinician Initiated Submission Form. 
As a result, the other payer arrangement would not be considered an 
Other Payer Advanced APM for the year. These determinations are final 
and not subject to reconsideration.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: A few commenters expressed concern with the requirement 
that additional information be submitted within 10 business days, and 
one commenter suggested that 30 days would be a better timeframe.
    Response: We believe that responding to requests for additional 
information will generally be a straightforward process, and that the 
process and timeline for responding to these requests will allow us to 
verify information while making determinations in an expeditious 
manner. That said, we also recognize that APM Entities and eligible 
clinicians may need some additional time to respond to requests.
    Comment: One commenter suggested that CMS send both an electronic 
and hard copy of the request for additional information to ensure rapid 
response from the eligible clinician. In addition, the commenter stated 
that eligible clinicians should be allowed to respond via fax, email or 
other electronic methods as necessary.
    Response: We are implementing an electronic method to facilitate 
the rapid exchange of information between us and APM Entities or 
eligible clinicians. We believe that routinely providing both 
electronic and hard copy documents would create additional burden and 
unnecessary cost to CMS with very little benefit.
    Final Action: After considering public comments, we are finalizing 
our proposal that, if we determine that the APM Entity or eligible 
clinician has submitted incomplete or inadequate information, we would 
inform the APM Entity or eligible clinician. We are finalizing a 
modification to our proposal, which is that we will allow the APM 
Entity or eligible clinician to submit additional information no later 
than 15 business days from the date we inform the APM Entity or 
eligible clinician that the submission contains incomplete or 
inadequate information. For each other payer arrangement for which the 
APM Entity or eligible clinician does not submit sufficient 
information, we would not make a determination in response to that 
request submitted via the Eligible Clinician Initiated Submission Form. 
As a result, the other payer arrangement would not be considered an 
Other Payer Advanced APM for the year. These determinations are final 
and not subject to reconsideration. We are finalizing this policy for 
all of the Eligible Clinician Initiated Process, regardless of the type 
of payment arrangement being submitted.
    CMS Notification: We proposed to notify APM Entities and eligible 
clinicians of our determinations for each other payer arrangement for 
which a determination was requested as soon as practicable after the 
Submission Deadline.
    In the CY 2018 Quality Payment Program proposed rule, we noted that 
APM Entities and eligible clinicians who submit complete Eligible 
Clinician Initiated Submission Forms by September 1 of the same 
calendar year as the relevant QP Performance Period may allow for us to 
make Other Payer Advanced APM determinations and inform APM Entities or 
eligible clinicians of those determinations prior to the December 1 QP 
Determination Submission Deadline. If we determine that an other payer 
arrangement is not an Other Payer Advanced APM, notifying APM Entities 
or eligible clinicians of such a determination may help them avoid the 
burden of submitting payment amount and patient count information for 
that payment arrangement. We intend to make these early notifications 
to the extent possible. We proposed that APM Entities or eligible 
clinicians may submit information regarding an other payer arrangement 
for a subsequent QP Performance Period even if we have determined that 
the other payer arrangement is not an Other Payer Advanced APM for a 
prior year (82 FR 30185).
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Two commenters stated that for eligible clinicians who 
submit their information after December 1, CMS should commit to make a 
determination within 30 calendar days of when the applicable 
information is submitted. Two other commenters stated that CMS should 
establish a firm deadline for notifying eligible clinicians the results 
of Other Payer Advanced APM determinations.
    Response: We are trying to provide as much certainty and notice in 
the Eligible Clinician Initiated Process as possible especially because 
this coming year will be the first year where we implement the Eligible 
Clinician Initiated Process. We note that we are committed to making 
Other Payer Advanced APM determinations as soon as practicable.
    Final Action: After considering public comments, we are finalizing 
our proposal to notify APM Entities and eligible clinicians of our 
determinations for each other payer arrangement for which a 
determination was requested as soon as practicable after the Submission 
Deadline. We are finalizing this proposal for all of the Eligible 
Clinician Initiated Process, regardless of the type of payment 
arrangement being submitted. We codify this policy at Sec.  
414.1445(f).
    CMS Posting of Other Payer Advanced APMs: We noted that we intend 
to post on the CMS Web site a list (which we refer to as the Other 
Payer Advanced APM List) of all of the other payer arrangements that we 
determine to be Other Payer Advanced APMs. Prior to the start of the 
relevant QP Performance Period, we intend to post the Other Payer 
Advanced APMs that we determine through the Payer Initiated Process and 
Other Payer Advanced APMs under Title XIX that we determine through the 
Eligible Clinician Initiated Process. After the QP Performance Period, 
we would update this list to include Other Payer Advanced APMs that we 
determine

[[Page 53860]]

based on other requests through the Eligible Clinician Initiated 
Process.
    We still intend to post this list prior to the start of the 
relevant QP Performance Period and update it to include Other Payer 
Advanced APMs that we determine based on requests received through the 
Eligible Clinician Initiated Process.
(2) Medicaid APMs and Medicaid Medical Home Models
    In the CY 2018 Quality Payment Program proposed rule, we noted that 
payers, APM Entities, and eligible clinicians may request that we 
determine whether payment arrangements authorized under Title XIX of 
the Act are Medicaid APMs or Medicaid Medical Home Models that meet the 
Other Payer Advanced APM criteria. We explained that there are some 
differences between the determination process for other payer 
arrangements where Medicaid is the payer and the process for other 
payer arrangements with other types of payers. These differences stem 
in part from the requirements specified in sections 
1833(z)(2)(B)(ii)(bb) and 1833(z)(2)(C)(ii)(bb) of the Act for QP 
determinations under the All-Payer Combination Option. We noted that we 
interpret those statutory provisions to direct us, when making QP 
determinations under the All-Payer Combination Option, to exclude from 
the calculation of ``all other payments'' any payments made (or 
patients under the patient count method) under Title XIX in a state in 
which there is no available Medicaid APM (which by definition at Sec.  
414.1305 meets the Other Payer Advanced APM criteria) or Medicaid 
Medical Home Model that meets the Other Payer Advanced APM criteria (82 
FR 30185).
    To implement this requirement, we explained in the CY 2018 Quality 
Payment Program proposed rule that we need to determine which states 
have no available Medicaid APMs or Medicaid Medical Home Models that 
meet the Other Payer Advanced APM criteria during a given QP 
Performance Period. We noted that we believe that it is important for 
us to make this determination prior to the QP Performance Period, and 
to announce the Medicaid APMs and Medicaid Medical Home Models that 
meet the Other Payer Advanced APM criteria and the locations where they 
are available, so that eligible clinicians can assess whether their 
Title XIX payments and patients would be excluded under the All-Payer 
Combination Option for that particular performance year. If, for a 
given state, we receive no requests to make determinations for other 
payer arrangements that could be Medicaid APMs or Medicaid Medical Home 
Models that are Other Payer Advanced APMs for the year through either 
the Payer Initiated Process or the Eligible Clinician Initiated 
Process, we would assume that there are no Medicaid APMs or Medicaid 
Medical Home Models that meet the Other Payer Advanced APM criteria in 
that state for the relevant QP Performance Period. Accordingly, we 
would exclude Title XIX payments and patients from the All-Payer 
Combination Option calculations for eligible clinicians in that state 
(82 FR 30185).
(a) Payer Initiated Process
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that any states and territories (which we refer to as states) that have 
in place a state plan under Title XIX may request that we determine 
prior to the QP Performance Period whether other payer arrangements 
authorized under Title XIX are Medicaid APMs or Medicaid Medical Home 
Models that meet the Other Payer Advanced APM criteria, in other words, 
are Other Payer Advanced APMs, under the Payer Initiated Process. 
States include the 50 states, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, 
and the Northern Mariana Islands.
    We proposed to allow states to request determinations for both 
Medicaid fee-for-service and Medicaid managed care plan payment 
arrangements. We explained that states often use managed care plan 
contracts to implement payment arrangements, and a substantial portion 
of the Medicaid beneficiary population receives their health care 
services through Medicaid managed care plans. We noted that we expect 
that states would work closely with their managed care plans to 
identify and collect relevant information. However, we proposed to 
accept requests regarding payment arrangements authorized under Title 
XIX under the Payer Initiated Process only from the state, not from a 
Medicaid managed care plan, as states are responsible ultimately for 
the administration of their Medicaid programs (82 FR 30186).
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter supported CMS's proposal that, under the 
Payer Initiated Process, states alone are responsible for submission of 
information on payment arrangements authorized under Title XIX.
    Response: We appreciate the commenter's support for our proposal.
    Comment: Some commenters requested Medicaid managed care plans be 
allowed to submit their payment arrangement information directly to us. 
These commenters stated that it would be a burden for state agencies to 
submit all of the Medicaid payment arrangements within the state as we 
proposed. These commenters also pointed out that some Medicaid managed 
care organizations operate Medicaid payments across multiple states and 
the proposed process would create an additional burden on the Medicaid 
managed care organizations. Alternatively, a few commenters suggested 
that states be given the option of either submitting all information 
regarding Medicaid payment arrangements in their state, or delegating 
the submission of Medicaid managed care plan payment arrangement to the 
plans.
    Response: We believe that our proposal allows for states to prepare 
the Payer Initiated Submission Form for Medicaid payment arrangements 
and provides a uniform process for all states to follow. We believe 
that this approach would create one source of information from each 
state on Medicaid APMs and Medicaid Medical Home Models that could be 
determined to be Other Payer Advanced APMs, which will allow us to 
properly carry out the statutory Medicaid exclusion. We note that if 
Medicaid managed care plans were to submit information on payment 
arrangements directly, states might not be aware of all of the Medicaid 
payment arrangements submitted from Medicaid managed care plans in 
their state. This may require additional follow-up inquiries with 
states to confirm the existence and characteristics of certain Medicaid 
managed care payment arrangements. Similarly, if states were given the 
option of either submitting the information regarding all Medicaid 
payment arrangements in their state, or delegating the submission of 
Medicaid managed care plans, an additional up-front survey of states 
regarding which option they will be pursuing would be needed. We do not 
think such a survey is feasible, given other program deadlines. We also 
believe that having multiple standards across different states is 
likely to add to the complexity of the process, and may be confusing to 
stakeholders.
    Comment: One commenter suggested that states be allowed to submit 
information on payment arrangements across other public payers, such as 
public employee benefit programs.

[[Page 53861]]

    Response: For the first year, we will limit the types of payment 
arrangements for which states can submit information. As we discuss in 
section II.D.6.c.(3)(a) of this final rule with comment period, if a 
payment arrangement with a public payer is aligned with a payment 
arrangement authorized under Title XIX, a state may also submit that 
payment arrangement for an Other Payer Advanced APM determination. We 
note that APM Entities or eligible clinicians may submit payment 
arrangement information for a payment arrangement with a public payer 
that is not authorized under Title XIX after the QP Performance Period 
beginning in the first year. We expect that states will be able to 
directly submit information about these arrangements, even if they are 
not aligned with a payment arrangement authorized under Title XIX, when 
we allow for all payer types to submit payment arrangement information 
in 2019, prior to performance year 2020.
    Final Action: After considering public comments, we are finalizing 
our proposal that states that have in place a payment arrangement 
authorized under Title XIX may request that we determine prior to the 
QP Performance Period whether other payer arrangements authorized under 
Title XIX are Medicaid APMs or Medicaid Medical Home Models that meet 
the Other Payer Advanced APM criteria, in other words, are Other Payer 
Advanced APMs, under the Payer Initiated Process. We are also 
finalizing our proposal to allow states to request determinations for 
both Medicaid fee-for-service and Medicaid managed care plan payment 
arrangements, and we are finalizing our proposal to accept requests 
regarding payment arrangements authorized under Title XIX under the 
Payer Initiated Process only from the state, not from a Medicaid 
managed care plan.
    Below we discuss our final policies for the Payer Initiated Process 
for payment arrangements authorized under Title XIX.
    Guidance and Submission Form: We discuss our final policies 
pertaining to the Guidance and Submission Form in section 
II.D.6.c.(1)(b) of this final rule with comment period as to all payer 
types in the Payer Initiated Process, including payment arrangements 
authorized under Title XIX.
    We intend to work with states as they prepare and submit Payer 
Initiated Submission Forms for our review. In completing the Payer 
Initiated Submission Form, states could refer to information they have 
already submitted to us regarding their payment arrangements to support 
their request for a determination. This information could include, for 
example, submissions that states typically make to us to obtain 
authorization to modify their Medicaid payment arrangements, such as a 
State Plan Amendment or an 1115 demonstration's waiver application, 
Special Terms and Conditions document, implementation protocol 
document, or other document describing the 1115 demonstration 
arrangements approved by CMS.
    Submission Period: We proposed that the Submission Period for the 
Payer Initiated Process for use by states to request Other Payer 
Advanced APM determinations for other payer arrangements authorized 
under Title XIX will open on January 1 of the calendar year prior to 
the relevant QP Performance Period for which we would make Other Payer 
Advanced APM determinations. We proposed that the Submission Deadline 
is April 1 of the year prior to the QP Performance Period for which we 
would make the determination.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter suggested that states should be allowed to 
submit information on Medicaid payment arrangements on a rolling basis 
rather than following a set schedule.
    Response: We believe that it is important for both payers and us, 
particularly in the first year of implementing the Payer Initiated 
Process, to have a clear structure for the Eligible Clinician Initiated 
Process that can be easily understood. We may consider making changes 
to the overall approach to the Submission Period for payment 
arrangements authorized under Title XIX when we have more information 
and experience in operating the Payer Initiated Process. We are also 
concerned that if we have a rolling process, especially because we need 
the information to implement the Medicaid exclusion prior to the QP 
Performance Period, accepting requests for Other Payer Advanced APMs on 
a rolling basis may prevent us from having a complete list of Medicaid 
APMs and Medicaid Medical Home Models that are Other Payer Advanced 
APMs prior to the relevant QP Performance Period.
    Final Action: After considering public comments, we are finalizing 
our proposals that the Submission Period for the Payer Initiated 
Process for use by states to request Other Payer Advanced APM 
determinations for other payer arrangements authorized under Title XIX 
will open on January 1 of the calendar year prior to the relevant QP 
Performance Period for which we would make the determination for a 
Medicaid APM or a Medicaid Medical Home Model that is an Other Payer 
Advanced APM and that the Submission Deadline is April 1 of the year 
prior to the QP Performance Period for which we would make the 
determination.
    CMS Determination: Upon the timely receipt of a Payer Initiated 
Submission Form, we would use the information submitted to determine 
whether the other payer arrangement meets the Other Payer Advanced APM 
criteria. We proposed that, if we determine that the state has 
submitted incomplete or inadequate information, we would inform the 
state and allow the state to submit additional information no later 
than 10 business days from the date we inform the state. For each other 
payer arrangement for which the state does not submit sufficient 
information, we would not make a determination in response to that 
request submitted via the Payer Initiated Submission Form. As a result, 
the other payer arrangement would not be considered an Other Payer 
Advanced APM for the year. These determinations are final and not 
subject to reconsideration.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: One commenter stated that certain Medicaid programs, such 
as the New York Delivery System Reform Incentive Program (DSRIP), 
should be deemed Other Payer Advanced APMs because participants in such 
programs that accept two-sided risk are likely to meet the Other Payer 
Advanced APM criteria.
    Response: While any Medicaid payment arrangement may meet the Other 
Payer Advanced APM criteria, such determinations are made through the 
Other Payer Advanced APM determination process as described in this 
final rule with comment period. For example, New York State can choose 
to submit information about this program to us through the Payer 
Initiated Process and we can make that determination. Alternatively, 
APM Entities or eligible clinicians can submit information about this 
program to us through the Eligible Clinician Initiated Process. We will 
work with states as they develop innovative Medicaid models and assist 
then in designing payment arrangements that meet the criteria to be 
Other Payer Advanced APMs.
    Final Action: We discuss our final policies pertaining to the CMS 
Determination in section II.D.6.c.(1)(b) of this final rule with 
comment period as to all payer types in the Payer Initiated Process, 
including payment

[[Page 53862]]

arrangements authorized under Title XIX.
    CMS Notification: We proposed to notify states of our 
determinations for each request as soon as practicable after the 
relevant Submission Deadline. We proposed that states may submit 
information regarding an other payer arrangement for a subsequent QP 
Performance Period even if we have determined that the other payer 
arrangement is not an Other Payer Advanced APM for a prior year.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter expressed concern about the timeline, 
stating that because CMS may make Other Payer Advanced APM 
determinations as late as the September preceding the QP Performance 
Period, there may be insufficient time for the Medicaid agency, 
Medicaid managed care organizations, and contracted health care 
providers to negotiate and update contracts.
    Response: We appreciate the concern. We note that we will notify 
states of Other Payer Advanced APM determinations as soon as they are 
completed after the April 1 Submission Deadline.
    Final Action: We discuss our final policies pertaining to the CMS 
Notification in section II.D.6.c.(1)(b) of this final rule with comment 
period as to all payer types in the Payer Initiated Process, including 
payment arrangements authorized under Title XIX.
    CMS Posting of Other Payer Advanced APMs: We explained our policy 
in section II.D.6.c.(1)(b) of this final rule with comment period.
    We intend to provide ongoing assistance through existing 
conversations or negotiations as states design and develop new payment 
arrangements that may be identified as Other Payer Advanced APMs. As 
states begin discussions with us regarding the development of other 
payer arrangements through the different legal authorities available 
under Title XIX or Title XI of the Act, we would help states consider 
and address the Other Payer Advanced APM criteria.
(b) Eligible Clinician Initiated Process
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that APM Entities and eligible clinicians may request determinations 
for any Medicaid payment arrangements in which they are participating 
at an earlier point, prior to the QP Performance Period. This would 
allow all clinicians in a given state or county to know before the 
beginning of the QP Performance Period whether their Title XIX payments 
and patients would be excluded from the all-payer calculations that are 
used for QP determinations for the year under the All-Payer Combination 
Option.
    We sought comment on this proposal. The following is a summary of 
the public comments received on this proposal and our responses:
    Comment: One commenter supported CMS's proposed approach for 
obtaining information from eligible clinicians participating in 
Medicaid payment arrangements and doing so prior to the QP Performance 
Period.
    Response: We appreciate the support of our proposed approach.
    Final Action: After considering public comments, we are finalizing 
our proposal that APM Entities and eligible clinicians may request 
determinations for any Medicaid payment arrangements in which they are 
participating prior to the relevant QP Performance Period.
    Below we discuss our policies for the Eligible Clinician Initiated 
Process for payment arrangements authorized under Title XIX.
    Guidance and Submission Form: We discuss our final policies 
pertaining to the Guidance and Submission Form in section 
II.D.6.c.(1)(c) of this final rule with comment period for all of the 
Eligible Clinician Initiated Process, including for requests that are 
payment arrangements authorized under Title XIX.
    Submission Period: We proposed that APM Entities or eligible 
clinicians may submit Eligible Clinician Initiated Forms for payment 
arrangements authorized under Title XIX beginning on September 1 of the 
calendar year prior to the QP Performance Period. We also proposed that 
the Submission Deadline is November 1 of the calendar year prior to the 
QP Performance Period.
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing this policy as proposed.
    CMS Determination: We discuss our final policies pertaining to the 
CMS Determination in section II.D.6.c.(1)(c) of this final rule with 
comment period for all of the Eligible Clinician Initiated Process, 
including for requests that are payment arrangements authorized under 
Title XIX.
    CMS Notification: We discuss our final policies pertaining to the 
CMS Notification in section II.D.6.c.(1)(c) of this final rule with 
comment period for all of the Eligible Clinician Initiated Process, 
including for requests that are payment arrangements authorized under 
Title XIX.
    CMS Posting of Other Payer Advanced APMs: We explained our policy 
in section II.D.6.c.(1)(c) of this final rule with comment period.
(c) Final Timeline
    The final timelines for both the Payer Initiated and Eligible 
Clinician Initiated Other Payer Advanced APM Determination Processes 
for payment arrangements authorized under Title XIX are summarized in 
Table 38.

Table 38--Other Payer Advanced APM Determination Process for Payment Arrangements Authorized Under Title XIX for
                                           QP Performance Period 2019
----------------------------------------------------------------------------------------------------------------
                                                                           Eligible clinician
                                  Payer initiated            Date            (EC) initiated           Date
                                      process                                  process *
----------------------------------------------------------------------------------------------------------------
Medicaid.....................  Guidance sent to       Jan. 2018........  Guidance made          Sept. 2018.
                                states, then                              available to ECs,
                                Submission Period                         then Submission
                                Opens.                                    Period Opens.
                               Submission Period      April 2018.......  Submission Period      Nov. 2018.
                                Closes.                                   Closes.
                               CMS contacts states    Sept. 2018.......  CMS contacts ECs and   Dec. 2018.
                                and posts Other                           states and posts
                                Payer Advanced APM                        Other Payer Advanced
                                List.                                     APM List.
----------------------------------------------------------------------------------------------------------------
* Note that APM Entities or eligible clinicians may use the Eligible Clinician Initiated Process.

(3) CMS Multi-Payer Models
    For purposes of carrying out the Quality Payment Program, we 
proposed to define the term CMS Multi-Payer Model at Sec.  414.1305 as 
an Advanced APM that CMS determines, per the terms of the Advanced APM, 
has at least one other payer arrangement that is designed to align with 
the terms of that Advanced APM. Examples of CMS Multi-Payer Models 
include the Comprehensive Primary Care Plus

[[Page 53863]]

(CPC+) Model, the Oncology Care Model (OCM) (2-sided risk arrangement), 
and beginning in 2019, the Vermont All-Payer ACO Model.\20\
---------------------------------------------------------------------------

    \20\ Vermont ACOs will be participating in an Advanced APM 
during 2018 through a modified version of the Next Generation ACO 
Model. The Vermont Medicare ACO Initiative will be an Advanced APM 
beginning in 2019.
---------------------------------------------------------------------------

    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing our proposal to define the term CMS 
Multi-Payer Model as an Advanced APM that CMS determines, per the terms 
of the Advanced APM, has at least one other payer arrangement that is 
designed to align with the terms of that Advanced APM at Sec.  
414.1305.
    Other payer arrangements that are aligned with a CMS Multi-Payer 
Model, by definition, are not APMs, and thus, cannot be Advanced APMs 
under the Medicare Option. We recognize, though, that these other payer 
arrangements could be Other Payer Advanced APMs. We therefore proposed 
that beginning in the first QP Performance Period under the All-Payer 
Combination Option, payers with other payer arrangements aligned with a 
CMS Multi-Payer Model may request that we determine whether those 
aligned other payer arrangements are Other Payer Advanced APMs. Because 
there may be differences between the other payer arrangements that are 
aligned with an Advanced APM in a CMS Multi-Payer Model, we proposed to 
make separate determinations about each of those other payer 
arrangements on an individual basis. In other words, an other payer 
arrangement aligned with an Advanced APM in a CMS Multi-Payer Model is 
not automatically an Other Payer Advanced APM by virtue of its 
alignment.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: A few commenters suggested that CMS streamline the 
determination process for a payment arrangement aligned with a CMS 
Multi-Payer Model by using information that CMS has already collected 
for other purposes. One commenter also suggested that CMS automatically 
determine whether a payment arrangement aligned with a CMS Multi-Payer 
Model are Other Payer Advanced APMs, and the commenter stated that this 
automatic determination would be an opportunity for us to reduce 
administrative burden on payers and eligible clinicians.
    Response: We have, or will have, some information regarding these 
other payment arrangement by virtue of their alignment with a CMS 
Multi-Payer Model. Where feasible, we will use information that we 
already have to help streamline the process to make Other Payer 
Advanced APM determinations. Payers with payment arrangements aligned 
with a CMS Multi-Payer Model will only be required to submit any 
additional information needed to make a determination, which would be 
identified in communications between the payer and CMS. We do not 
believe it would be appropriate, however, for other payment 
arrangements to automatically be determined to be Other Payer Advanced 
APMs. The payment arrangements offered by non-Medicare payers aligned 
with a Multi-Payer Model are not necessarily required to align 
completely with the Advanced APM components of the model. In addition, 
the criteria for determining Advanced APMs and Other Payer Advanced 
APMs, while similar, are not identical. As such, simply being aligned 
as part of a Multi-Payer Model is not in itself sufficient evidence 
that a payment arrangement meets the criteria to be an Other Payer 
Advanced APM.
    Final Action: After considering public comments, we are finalizing 
our proposal that beginning in the first QP Performance Period under 
the All-Payer Combination Option, payers with a payment arrangement 
aligned with a CMS Multi-Payer Model may request that we determine 
whether that aligned payment arrangement is an Other Payer Advanced 
APM. We are also finalizing our proposal to make separate 
determinations about each of those other payer arrangements on an 
individual basis.
    In the CY 2018 Quality Payment Program proposed rule, we stated 
that because there can be payment arrangements authorized under Title 
XIX or Medicare Health Plan payment arrangements that are aligned with 
a CMS Multi-Payer Model, we proposed that payers, APM Entities, or 
eligible clinicians who want to request that we determine whether those 
arrangements are Other Payer Advanced APMs would use the processes 
specified for payment arrangements authorized under Title XIX and 
Medicare Health Plan payment arrangements (82 FR 30188).
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing our proposal that payers, APM 
Entities, or eligible clinicians who want to request that we determine 
whether those arrangements are Other Payer Advanced APMs would use the 
processes specified for payment arrangements authorized under Title XIX 
and Medicare Health Plan payment arrangements.
(a) Payer Initiated Process
    Below we discuss our policies for the Payer Initiated Process for 
payment arrangements aligned with a CMS Multi-Payer Model.
    Guidance and Submission Form: We discuss our final policies 
pertaining to the Guidance and Submission Form in section 
II.D.6.c.(1)(b) of this final rule with comment period as to all payer 
types in the Payer Initiated Process, including payment arrangements 
that are aligned with a CMS Multi-Payer Model.
    Submission Period: We proposed that the Submission Period would 
open on January 1 of the calendar year prior to the relevant QP 
Performance Period. We also proposed that the Submission Period would 
close on June 1 of the calendar year prior to the relevant QP 
Performance Period.
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing this policy as proposed with one 
modification. Due to technical error, we inadvertently stated that June 
30 is the deadline for this Submission Period. We are finalizing that 
the Submission Period will close on June 1 of the calendar year prior 
to the relevant QP Performance Period.
    CMS Determination: We discuss our final policies pertaining to the 
CMS Determination in section II.D.6.c.(1)(b) of this final rule with 
comment period as to all payer types in the Payer Initiated Process, 
including payment arrangements that are aligned with a CMS Multi-Payer 
Model.
    CMS Notification: We discuss our final policies pertaining to the 
CMS Determination in section II.D.6.c.(1)(b) of this final rule with 
comment period as to all payer types in the Payer Initiated Process, 
including payment arrangements that are aligned with a CMS Multi-Payer 
Model.
    CMS Posting of Other Payer Advanced APMs: We explained our policy 
in section II.D.6.c.(1)(b) of this final rule with comment period as to 
all payer types in the Payer Initiated Process, including payment 
arrangements that are aligned with a CMS Multi-Payer Model.
(b) Eligible Clinician Initiated Process
    Below we discuss our policies for the Eligible Clinician Initiated 
Process for payment arrangements aligned with a CMS Multi-Payer Model.

[[Page 53864]]

    Guidance and Submission Form: We discuss our final policies 
pertaining to the Guidance and Submission Form in II.D.6.c.(1)(c) of 
this final rule with comment period for all of the Eligible Clinician 
Initiated Process, including payment arrangements that are aligned with 
a CMS Multi-Payer Model.
    Submission Period: We proposed that APM Entities or eligible 
clinicians may request Other Payer Advanced APM determinations 
beginning on August 1 of the same year as the relevant QP Performance 
Period. We proposed that the Submission Deadline for requesting Other 
Payer Advanced APM determinations, as well as to request QP 
determinations under the All-Payer Combination Option, is December 1 of 
the same year as the relevant QP Performance Period.
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing our proposals that the Submission 
Period will open on August 1 of the same year as the relevant QP 
Performance Period and close on December 1 of the same year as the 
relevant QP Performance Period.
    CMS Determination: We discuss our final policies pertaining to the 
CMS Determination in section II.D.6.c.(1)(c) of this final rule with 
comment period for all of the Eligible Clinician Initiated Process, 
including payment arrangements that are aligned with a CMS Multi-Payer 
Model.
    CMS Notification: We discuss our final policies pertaining to the 
CMS Notification in section II.D.6.c.(1)(c) of this final rule with 
comment period for all of the Eligible Clinician Initiated Process, 
including payment arrangements that are aligned with a CMS Multi-Payer 
Model.
    CMS Posting of Other Payer Advanced APMs: We explained our policy 
in section II.D.6.c.(1)(c) of this final rule with comment period for 
all of the Eligible Clinician Initiated Process, including payment 
arrangements that are aligned with a CMS Multi-Payer Model.
(c) State All-Payer Models
    Some CMS Multi-Payer Models involve an agreement with a state to 
test an APM and one or more associated other payer arrangements in that 
state where the state prescribes uniform payment arrangements across 
state-based payers. As such, we believe it may be appropriate and 
efficient for states, rather than any other payer, to submit 
information to us on these payment arrangements for purposes of 
requesting an Other Payer Advanced APM determination.
    We proposed that, in CMS Multi-Payer Models where a state 
prescribes uniform payment arrangements across all payers statewide, 
the state would submit on behalf of payers in the Payer Initiated 
Process for Other Payer Advanced APMs; we would seek information for 
the determination from the state, rather than individual payers. The 
same Payer Initiated Process and timeline described above for CMS 
Multi-Payer Models would apply. We sought comment on this proposal. 
Additionally, we sought comment regarding the effectiveness of taking a 
similar approach in cases where the state does not require uniform 
payment arrangements across payers.
    We sought comment on this proposal. We received no comments in 
response to our proposal.
    Final Action: We are finalizing our proposal that where a state 
prescribes uniform payment arrangements across all payers statewide, 
the state would use the Payer Initiated Process to submit information 
on behalf of payers to support Other Payer Advanced APM 
determination(s); we would seek information for the determination from 
the state, rather than individual payers.
(d) Final Timeline
    The final timelines for both the Payer Initiated and Eligible 
Clinician Initiated Other Payer Advanced APM Determination Processes 
for payment arrangements aligned with a CMS Multi-Payer Model are 
summarized in Table 39.

  Table 39--Other Payer Advanced APM Determination Process for CMS Multi-Payer Models for QP Performance Period
                                                      2019
----------------------------------------------------------------------------------------------------------------
                                                                           Eligible clinician
                                  Payer initiated            Date           (EC) * initiated          Date
                                      process                                   process
----------------------------------------------------------------------------------------------------------------
CMS Multi-Payer Models.......  Guidance made          Jan. 2018........  Guidance made          Aug. 2019.
                                available to payers--                     available to ECs--
                                Submission Period                         Submission Period
                                Opens.                                    Opens.
                               Submission Period      June 2018........  Submission Period      Dec. 2019.
                                Closes.                                   Closes.
                               CMS contacts payers    Sept. 2018.......  CMS contacts ECs and   Dec. 2019.
                                and Posts Other                           Posts Other Payer
                                Payer Advanced APM                        Advanced APM List.
                                Lists.
----------------------------------------------------------------------------------------------------------------
* Note that APM Entities or eligible clinicians may use the Eligible Clinician Initiated Process.

(4) Medicare Health Plans
    In the CY 2018 Quality Payment Program proposed rule, we noted that 
the Medicare Option for QP determinations under sections 1833(z)(2)(A), 
(2)(B)(i), and (2)(C)(i) of the Act, is based only on the percentage of 
Part B payments for covered professional services, or patients, that is 
attributable to payments through an Advanced APM. As such, payment 
amounts or patient counts under Medicare Health Plans, including 
Medicare Advantage, Medicare-Medicaid Plans, 1876 Cost Plans, and 
Programs of All Inclusive Care for the Elderly (PACE) plans, cannot be 
included in the QP determination calculations under the Medicare Option 
(81 FR 77473-77474). Instead, eligible clinicians who participate in 
Other Payer Advanced APMs, including those with Medicare Advantage as a 
payer, could become QPs based on that participation during the 2019 QP 
Performance Period in payment year 2021 (82 FR 30190). However, 
eligible clinicians who participate in Other Payer Advanced APMs with 
Medicare Advantage as the payer can only achieve QP status if they also 
participate in an Advanced APM with Medicare fee-for-service.
    In light of these statutory limitations, as noted in the CY 2018 
Quality Payment Program proposed rule, we received feedback in support 
of the idea of also incentivizing eligible clinician participation in 
alternative payment arrangements under Medicare Advantage by providing 
credit for that participation in QP determinations under the Medicare 
Option. We noted in the CY 2018 Quality Payment Program proposed rule 
that we were considering opportunities to address this issue, and we 
sought comment on such opportunities, including potential models and 
uses of our waiver and demonstration authorities. Under the

[[Page 53865]]

All-Payer Combination Option, eligible clinicians can become QPs based 
in part on payment amounts or patient counts associated with other 
payer arrangements through Medicare Health Plans, provided that such 
arrangements meet the criteria to be Other Payer Advanced APMs. We note 
that the financial relationship between the Medicare Health Plan and 
CMS is not relevant to determination of whether a plan is an Other 
Payer Advanced APM. We note that under our approach to making Other 
Payer Advanced APM determinations, because QP determinations are made 
for eligible clinicians, only the payment arrangement between a 
Medicare Health Plan and an eligible clinician is relevant when 
determining whether a payment arrangement is an Other Payer Advanced 
APM.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: Many commenters supported CMS's exploring ways, perhaps 
through a demonstration project testing the effects of doing so, that 
eligible clinician participation in alternative Medicare Advantage 
payment arrangements could be counted in the QP determinations under 
the Medicare Option. Many of these commenters suggested potential 
models and ways to use CMS waiver and demonstration authorities. One 
commenter urged CMS to proceed cautiously in undertaking a 
demonstration to include Medicare Advantage under the Medicare Option, 
suggesting that the MACRA statute does not provide credit for such 
participation under the Medicare Option. Another commenter stated that 
Medicare Advantage plans currently have a large degree of flexibility 
and should not be given special consideration within the Quality 
Payment Program beyond that already provided for in the statute.
    Response: We appreciate the comments, and agree that there is merit 
in testing the effects of incentives for eligible clinicians to 
participate in alternative payment arrangements with Medicare 
Advantage, especially in the case of eligible clinicians who would not 
receive credit for such participation under the regular APM incentive 
rules. We are pursuing this idea, and we are considering potential 
demonstration project designs that would do so.
    Final Action: While we are not taking any formal action with 
respect to commenters' suggestions in this final rule with comment 
period, we intend to develop a demonstration project to test the 
effects of expanding incentives for eligible clinicians to participate 
in innovative alternative payment arrangements under Medicare Advantage 
that qualify as Advanced APMs, by allowing credit for participation in 
such Medicare Advantage arrangements prior to 2019 and incentivizing 
participation in such arrangements in 2018 through 2024, which we 
believe is especially important for eligible clinicians who do not 
participate in Advanced APMs with Medicare fee-for-service. We expect 
that this will give us an opportunity to test whether giving clinicians 
incentives for participation in Advanced APMs with Medicare Advantage 
alone (without having to concurrently participate in an Advanced APM 
with Medicare fee-for-service) encourages more clinicians to move to 
the Advanced APM path under the Quality Payment Program. Unless there 
are significant methodological or other obstacles, we plan to proceed 
with providing an option along these lines.
(a) Payer Initiated Process
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that Medicare Health Plans may request that we determine whether their 
payment arrangements are Other Payer Advanced APMs prior to the QP 
Performance Period by submitting information contemporaneously with the 
annual bidding process for Medicare Advantage contracts (that is, 
submitted by the first Monday in June of the year prior to the payment 
and coverage year) (82 FR 30190).
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Some commenters expressed support for our proposal.
    Response: We appreciate the commenters' support of our proposal.
    Comment: One commenter requested that CMS clarify that provider-
sponsored Medicare Advantage payment arrangements could qualify as 
Other Payer Advanced APMs.
    Response: We clarify that all Medicare Advantage payment 
arrangements may be submitted to us for Other Payer Advanced APM 
determinations.
    Comment: Another commenter suggested that the process for Medicare 
Advantage is too complex and should be simplified.
    Response: We proposed that Medicare Health Plans may request that 
we determine whether their payment arrangements are Other Payer 
Advanced APMs prior to the QP Performance Period by submitting 
information contemporaneously with the annual bidding process for 
Medicare Advantage contracts. We continue to believe that this is the 
least complex and burdensome option available for Medicare Health 
Plans. As we gain experience with the All-Payer Combination Option, we 
will continue to explore additional opportunities to minimize the 
burden associated with completing the Payer Initiated Submission Form.
    Final Action: After considering public comments, we are finalizing 
our proposal to allow Medicare Health Plans to request that we 
determine whether their payment arrangements are Other Payer Advanced 
APMs in the year prior to the QP Performance Period by submitting 
information contemporaneously with the annual bidding process for 
Medicare Advantage contracts.
    Below we discuss our policies for the Payer Initiated Process for 
Medicare Health Plan payment arrangements.
    Guidance and Submission Form: We discuss our final policies 
pertaining to the Guidance and Submission Form in section 
II.D.6.c.(1)(b) of this final rule with comment period as to all payer 
types in the Payer Initiated Process, including Medicare Health Plans. 
We note that for Medicare Health Plans, the Payer Initiated Submission 
Form will be incorporated into the Health Plan Management System 
(HPMS).
    Submission Period: We proposed that the Submission Period would 
begin and end at the same time as the annual Medicare Advantage bid 
timeframe. We proposed the Submission Period would begin when the bid 
packages are sent out to plans in April of the year prior to the 
relevant QP Performance Period. We also proposed that the Submission 
Deadline would be the annual bid deadline, which would be the first 
Monday in June in the year prior to the relevant QP Performance Period.
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing our proposal that the Submission 
Period would begin and end at the same time as the annual Medicare 
Advantage bid timeframe.
    CMS Determination: The following is a summary of the public 
comments received on this proposal and our responses:
    Comment: One commenter suggested that CMS should assume that 
qualified risk contracts between payers and eligible clinicians in 
Medicare Advantage are Other Payer Advanced APMs.
    Response: We do not believe that it would be appropriate for us to 
presume that a payment arrangement meets the Other Payer Advanced APM 
criteria

[[Page 53866]]

without conducting an Other Payer Advanced APM determination. While 
some qualified risk contracts may meet the Other Payer Advanced APM 
criteria, others may not.
    Final Action: We discuss our final policies pertaining to the CMS 
Determination in section II.D.6.c.(1)(b) of this final rule with 
comment period as to all payer types in the Payer Initiated Process, 
including Medicare Health Plan payment arrangements.
    CMS Notification: We discuss our final policies pertaining to the 
CMS Notification in section II.D.6.c.(1)(b) of this final rule with 
comment period as to all payer types in the Payer Initiated Process, 
including Medicare Health Plan payment arrangements.
    CMS Posting of Other Payer Advanced APMs: We explained our policy 
in section II.D.6.c.(1)(b) of this final rule with comment period as to 
all payer types in the Payer Initiated Process, including Medicare 
Health Plan payment arrangements.
(b) Eligible Clinician Initiated Process
    We discuss policies for the Eligible Clinician Initiated Process 
for Medicare Health Plan payment arrangements below.
    Guidance and Submission Form: We discuss our final policies 
pertaining to the Guidance and Submission Form in section 
II.D.6.c.(1)(c) of this final rule with comment period for all of the 
Eligible Clinician Initiated Process, including Medicare Health Plan 
payment arrangements.
    Submission Period: We proposed that APM Entities or eligible 
clinicians may request Other Payer Advanced APM determinations 
beginning on August 1 of the same year as the relevant QP Performance 
Period. We proposed that the Submission Deadline for requesting Other 
Payer Advanced APM determinations, as well as to request QP 
determinations under the All-Payer Combination Option, is December 1 of 
the same year as the relevant QP Performance Period.
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing our proposal that APM Entities or 
eligible clinicians may request Other Payer Advanced APM determinations 
beginning on August 1 of the same year as the relevant QP Performance 
Period, and we are finalizing our proposal that the Submission Deadline 
is December 1 of the same year as the relevant QP Performance Period.
    CMS Determination: We discuss our final policies pertaining to the 
CMS Determination in section II.D.6.c.(1)(c) of this final rule with 
comment period for all of the Eligible Clinician Initiated Process, 
including Medicare Health Plan payment arrangements.
    CMS Notification: We discuss our final policies pertaining to the 
CMS Notification in section II.D.6.c.(1)(c) of this final rule with 
comment period for all of the Eligible Clinician Initiated Process, 
including Medicare Health Plan payment arrangements.
    CMS Posting of Other Payer Advanced APMs: We explained our policy 
on this topic for all eligible clinicians, regardless of payer type, 
including Medicare Health Plan payment arrangements, in section 
II.D.6.c.(1)(c) of this final rule with comment period.
(c) Final Timeline
    The final timelines for both the Payer Initiated and Eligible 
Clinician Initiated Other Payer Advanced APM Determination Processes 
for Medicare Health Plan payment arrangements are summarized in Table 
40.

  Table 40--Other Payer Advanced APM Determination Process for Medicare Health Plan Payment Arrangements for QP
                                             Performance Period 2019
----------------------------------------------------------------------------------------------------------------
                                                                           Eligible clinician
                                  Payer initiated            Date           (EC) * initiated          Date
                                      process                                   process
----------------------------------------------------------------------------------------------------------------
Medicare Health Plans........  Guidance sent to       April 2018.......  Guidance made          Aug. 2019.
                                Medicare Health                           available to ECs--
                                Plans--Submission                         Submission Period
                                Period Opens.                             Opens.
                               Submission Period      June 2018........  Submission Period      Dec. 2019.
                                Closes.                                   Closes.
                               CMS contacts Medicare  Sept. 2018.......  CMS contacts ECs and   Dec. 2019.
                                Health Plans and                          Posts Other Payer
                                Posts Other Payer                         Advanced APM List.
                                Advanced APM List.
----------------------------------------------------------------------------------------------------------------
* Note that APM Entities or eligible clinicians may use the Eligible Clinician Initiated Process.

(5) Remaining Other Payers
(a) Payer Initiated Process
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
to allow the remaining other payers not specifically addressed in 
proposals, including commercial and other private payers that are not 
states, Medicare Health Plans or payers with arrangements that are 
aligned with a CMS Multi-Payer Model, to request that we determine 
whether other payer arrangements are Other Payer Advanced APMs starting 
prior to the 2020 QP Performance Period and each year thereafter. We 
sought comment on this proposal, and we also sought comment on 
potential challenges to these other payers submitting information to us 
for Other Payer Advanced APM determinations. We noted that we intend to 
discuss the Payer Initiated Process for remaining other payers in more 
detail in future rulemaking (82 FR 30192).
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Many commenters opposed our proposal. These commenters 
stated that not allowing remaining other payers to submit payment 
arrangements for the 2019 QP Performance Period would limit eligible 
clinicians' ability to become QPs and believes that this approach is 
arbitrary. These commenters urged CMS to allow remaining other payers 
to submit payment arrangement information for Other Payer Advanced APM 
determinations prior to the 2019 QP Performance Period.
    Response: We appreciate the comments and the interest in remaining 
other payers' ability to request Other Payer Advanced APM 
determinations. We believe that limiting the payer types for the first 
year of implementation to those with which we already have a 
relationship is necessary for orderly initial implementation of the 
Payer Initiated Process. The payers for whom we have proposed to make 
the Payer Initiated Process available in 2019 have significant and 
long-standing pre-existing relationships with us, which we believe will 
significantly ease the burden of collecting the required information. 
We also note that we believe there is value in gradually implementing 
the Payer Initiated Process, as it requires us to collect categories of 
information with which we have little experience and may involve

[[Page 53867]]

unanticipated challenges. We look forward to using our experience 
during the first year of implementation as a basis for developing the 
capacity to make this process available to remaining other payers prior 
to the 2020 QP Performance Period, which we believe will include 
collecting information about the identity and type of such payers.
    We also note that APM Entities and eligible clinicians will be able 
to submit information about payment arrangements with remaining other 
payers through the Eligible Clinician Initiated Process for the 2019 QP 
Performance Period. Therefore, our proposal does not in any way prevent 
eligible clinicians from receiving credit for participation in such 
payment arrangements and thereby becoming QPs for the 2019 QP 
Performance Period.
    Final Action: After considering public comments, we are finalizing 
our proposal that the remaining other payers, including commercial and 
other private payers, may request that we determine whether other payer 
arrangements are Other Payer Advanced APMs starting prior to the 2020 
QP Performance Period and each year thereafter.
(b) Eligible Clinician Initiated Process
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that APM Entities and eligible clinicians may request that we determine 
whether an other payer arrangement with one of these other payers is an 
Other Payer Advanced APM beginning in the 2019 QP Performance Period 
(82 FR 30192).
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing our proposal that APM Entities and 
eligible clinicians may request that we determine whether an other 
payer arrangement with one of these other payers is an Other Payer 
Advanced APM beginning in the 2019 QP Performance Period.
    Below we discuss our final policies for the Eligible Clinician 
Initiated Process.
    Guidance and Submission Form: We discuss our final policies 
pertaining to the Guidance and Submission Form in section 
II.D.6.c.(1)(c) of this final rule with comment period for all of the 
Eligible Clinician Initiated Process, including payment arrangements 
with remaining other payers.
    Submission Period: We proposed that APM Entities or eligible 
clinicians may request Other Payer Advanced APM determinations 
beginning on August 1 of the same year as the relevant QP Performance 
Period. We proposed that the Submission Deadline for requesting Other 
Payer Advanced APM determinations, as well as to request QP 
determinations under the All-Payer Combination Option, is December 1 of 
the same year as the relevant QP Performance Period.
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing our proposal that APM Entities or 
eligible clinicians may request Other Payer Advanced APM determinations 
beginning on August 1 of the same year as the relevant QP Performance 
Period, and we are finalizing our proposal that the Submission Deadline 
for these requests is December 1 of the same year as the relevant QP 
Performance Period.
    CMS Determination: We discuss our final policies pertaining to the 
CMS Determination in section II.D.6.c.(1)(c) of this final rule with 
comment period for all of the Eligible Clinician Initiated Process, 
including payment arrangements with remaining other payers.
    CMS Notification: We discuss our final policies pertaining to the 
CMS Notification in section II.D.6.c.(1)(c) of this final rule with 
comment period for all of the Eligible Clinician Initiated Process, 
including payment arrangements with remaining other payers.
    CMS Posting of Other Payer Advanced APMs: We explained our policy 
for this topic in section II.D.6.c.(1)(c) of this final rule with 
comment period, including for requests that are payment arrangements 
with remaining other payers.
(c) Final Timeline
    The final timelines for both the Payer Initiated and Eligible 
Clinician Initiated Other Payer Advanced APM Determination Processes 
for payment arrangements for remaining other payers are summarized in 
Table 41.

 Table 41--Other Payer Advanced APM Determination Process for Remaining
     Other Payer Payment Arrangements for QP Performance Period 2019
------------------------------------------------------------------------
                                  Eligible clinician
                                    (EC) initiated            Date
                                      process *
------------------------------------------------------------------------
Remaining Other Payers........  Guidance made          Aug. 2019.
                                 available to ECs--
                                 Submission Period
                                 Opens.
                                Submission Period      Dec. 2019.
                                 Closes.
                                CMS contacts ECs and   Dec. 2019.
                                 Posts Other Payer
                                 Advanced APM List.
------------------------------------------------------------------------
* Note that APM Entities or eligible clinicians may use the Eligible
  Clinician Initiated Process.

(6) Final Timeline for the Other Payer Advanced APM Determination 
Processes
    The final timeline for both the Payer Initiated and Eligible 
Clinician Initiated Other Payer Advanced APM Determination Processes 
for all payer types is presented in Table 42.

[[Page 53868]]



                Table 42--Timeline for Other Payer Advanced APM Determination Process for the 2019 QP Performance Period by Payer Type *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Payment arrangements    Payment arrangements
                Year                          Date           authorized under Title    aligned with a CMS    Medicare health plan  Remaining other payer
                                                                       XIX             multi-payer model     payment arrangements   payment arrangements
--------------------------------------------------------------------------------------------------------------------------------------------------------
2018...............................  January...............  Guidance sent to        Guidance made
                                                              states--Submission      available to payers--
                                                              Period Opens.           Submission Period
                                                                                      Opens.
                                     April.................  Submission Period       .....................  Guidance sent to
                                                              Closes for states.                             Medicare Health
                                                                                                             Plans--Submission
                                                                                                             Period Opens.
                                     June..................  ......................  Submission Period      Submission Period
                                                                                      Closes for payers.     Closes for Medicare
                                                                                                             Health Plans.
                                     July-August...........  CMS makes Other Payer   CMS makes Other Payer  CMS makes Other Payer
                                                              Advanced APM            Advanced APM           Advanced APM
                                                              Determinations for      Determinations for     Determinations for
                                                              states.                 payers.                Medicare Health
                                                                                                             Plans.
                                     September.............  CMS posts Other Payer   CMS posts Other Payer  CMS posts Other Payer
                                                              Advanced APM List.      Advanced APM List.     Advanced APM List.
                                                             Guidance made
                                                              available to ECs--
                                                              Submission Period
                                                              Opens for ECs.
                                     November..............  Submission Period
                                                              Closes for ECs.
                                     December..............  CMS posts Other Payer
                                                              Advanced APM List.
2019...............................  August................  ......................  Submission Period      Submission Period      Submission Period
                                                                                      Opens for ECs.         Opens for ECs.         Opens for ECs.
                                     September.............  Submission Period for   Latest time where ECs  Latest time where ECs  Latest time where ECs
                                                              QP determination data   can request Other      can request Other      can request Other
                                                              opens.                  Payer Advanced APM     Payer Advanced APM     Payer Advanced APM
                                                                                      determinations to      determinations to      determinations to
                                                                                      get notification       get notification       get notification
                                                                                      prior to close of      prior to close of      prior to close of
                                                                                      data submission        data submission        data submission
                                                                                      period.                period.                period.
                                                                                     Submission Period for  Submission Period for  Submission Period for
                                                                                      QP determination       QP determination       QP determination
                                                                                      data opens.            data opens.            data opens.
                                     December..............  ......................  Submission Period      Submission Period      Submission Period
                                                                                      Closes for EC          Closes for EC          Closes for EC
                                                                                      requests for Other     requests for Other     requests for Other
                                                                                      Payer Advanced APM     Payer Advanced APM     Payer Advanced APM
                                                                                      determinations and     determinations and     determinations and
                                                                                      QP determination       QP determination       QP determination
                                                                                      data.                  data.                  data.
                                                                                     CMS makes Other Payer  CMS posts Other Payer  CMS makes Other Payer
                                                                                      Advanced APM           Advanced APM List.     Advanced APM
                                                                                      Determinations for                            Determinations for
                                                                                      ECs.                                          ECs.
                                                                                     CMS posts Other Payer  CMS makes Other Payer  CMS posts Other Payer
                                                                                      Advanced APM List.     Advanced APM           Advanced APM List.
                                                                                                             Determinations for
                                                                                                             ECs.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The process repeats beginning in 2019 for the 2020 QP Performance Period.

    The timeline for Other Payer Advanced APM Determination Process for 
the 2019 QP Performance Period by Payer Type table included in the CY 
2018 Quality Payment Program proposed rule had one typographical error 
(82 FR 30193). We correct and clarify in Table 42 in this final rule 
with comment period that guidance will be made to eligible clinicians, 
and submission will open, for payments authorized under Title XIX in 
September 2018, not June 2018.
    The following is a summary of the public comments received on the 
overall timeline and our responses:
    Comment: One commenter expressed support for the overall timeline 
for Other Payer Advanced APM determinations.
    Response: We appreciate the support for the overall timeline for 
Other Payer Advanced APM determinations.
    Final Action: After considering public comments, we are finalizing 
the overall timeline for Other Payer Advanced APM determinations as 
proposed.

[[Page 53869]]

(7) Submission of Information for Other Payer Advanced APM 
Determinations
    In the CY 2017 Quality Payment Program final rule, we finalized 
that to be assessed under the All-Payer Combination Option, APM 
Entities or eligible clinicians must submit, in a manner and by a date 
that we specify, payment arrangement information necessary to assess 
whether the other payer arrangement meets the Other Payer Advanced APM 
criteria (81 FR 77480). We are codifying the final policies pertaining 
to submission of information for Other Payer Advanced APM 
determinations in this section at Sec.  414.1445(c).
(a) Required Information
(i) Payer Initiated Process
    In the CY 2018 Quality Payment Program proposed rule, we noted that 
we intend to create a Payer Initiated Submission Form that would allow 
payers to submit the information necessary for us to determine whether 
a payment arrangement is an Other Payer Advanced APM. We proposed that, 
for each other payer arrangement for which a payer requests that we 
determine whether it is an Other Payer Advanced APM, the payer must 
complete and submit the Payer Initiated Submission Form by the relevant 
Submission Deadline (82 FR 30194). We finalized these proposals in 
section II.D.6.c.(1)(b) of this final rule with comment period.
    For us to make these determinations, in the CY 2018 Quality Payment 
Program proposed rule, we proposed to require that payers submit the 
following information for each other payer arrangement on the Payer 
Initiated Submission Form:
     Arrangement name;
     Brief description of the nature of the arrangement;
     QP Performance Period for which the arrangement is 
available;
     Participant eligibility criteria;
     Locations (nationwide, state, or county) where this other 
payer arrangement will be available;
     Evidence that the CEHRT criterion set forth in Sec.  
414.1420(b) is satisfied;
     Evidence that the quality measure criterion set forth in 
Sec.  414.1420(c) is satisfied, including an outcome measure;
     Evidence that the financial risk criterion set forth in 
Sec.  414.1420(d) is satisfied; and
     Other documentation as may be necessary for us to 
determine that the other payer arrangement is an Other Payer Advanced 
APM (82 FR 30194).
    We proposed that the Payer Initiated Submission Form would allow 
payers to include descriptive language for each of the required 
information elements. We proposed to require the name and description 
of the arrangement, nature of the arrangement, QP Performance Period 
for which the arrangement is available, participant eligibility 
criteria, and location(s) where the arrangement will be available so 
that we can verify whether eligible clinicians who may tell us that 
they participate in such arrangements are eligible to do so. We 
proposed that a submission for an Other Payer Advanced APM 
determination submitted by the payer is complete only if all of these 
information elements are submitted to us.
    We proposed to require that payers submit documentation that 
supports the information they provided in the Payer Initiated 
Submission Form and that is sufficient to enable us to determine 
whether the other payer arrangement is an Other Payer Advanced APM. 
Examples of such documentation would include contracts and other 
relevant documents that govern the other payer arrangement that verify 
each required information element, copies of their full contracts 
governing the arrangement, or some other documents that detail and 
govern the payment arrangement.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: A few commenters stated that while it is difficult to tell 
without the official form available, they expressed concerned that this 
level of documentation will be burdensome for both payers and eligible 
clinicians. One of these commenters also stated that it was unclear 
what evidence or other potentially necessary documentation would be 
needed short of providing the actual contract.
    Response: One of our goals in developing the processes for 
determining Other Payer Advanced APMs is to reduce burden to the extent 
possible. We plan to issue guidance to provide clarity on what 
supporting documentation is required. We clarify that we will accept 
redacted contracts or portions of contracts if the information 
submitted will allow us to make an Other Payer Advanced APM 
determination.
    Comment: Some commenters recommended that the Payer Initiated 
Process be simplified to require only the submission of an attestation 
that the payment arrangement is an Other Payer Advanced APM.
    Response: We continue to believe that when information on a payment 
arrangement is first submitted for the Payer Initiated Process, it is 
necessary that documentation be provided to support the responses in 
the Payer Initiated Submission Form. We believe that more than a simple 
attestation is necessary to ensure the integrity of the Payer Initiated 
Process. The Payer Initiated Submission Form and guidance will provide 
clarity on what information is needed and what supporting documentation 
is required. We note that for a payment arrangement that we have 
determined is Other Payer Advanced APM for a particular year, we may 
consider in future rulemaking methods to extend Other Payer Advanced 
APM determinations for a period longer than a single year, especially 
in cases where we can verify that the design and structure of the 
arrangement have not changed since we made our determination.
    Comment: One commenter stated that it would be administratively 
burdensome and, particularly in the case of states, could potentially 
impede the state's goals if we were to require the submission of 
information each year in order to consider whether to extend the 
determination that the arrangement is an Other Payer Advanced APM. This 
commenter recommended that CMS allow for multi-year determinations for 
Medicaid APMs when such determinations would align with the state's 
overall delivery system and payment reform strategies, or at minimum, 
CMS should create a streamlined redetermination process for Other Payer 
Advanced APMs that do not change from year to year.
    Response: In section II.D.6.c.(1)(b) of this final rule with 
comment period, we finalized that Other Payer Advanced APM 
determinations are only effective for one year at a time. As we 
mentioned above, we believe that is important to establish regular 
review of payment arrangements to ensure the criteria for Other Payer 
Advanced APMs are being met. In addition, we believe that annual review 
of Medicaid payment arrangements will facilitate the implementation of 
the Medicaid exclusion. We also note that some payment arrangements may 
change from one year to the next. We also recognize, however, that some 
payment arrangements may not change from year to year. Once a payment 
arrangement has been determined to be an Other Payer Advanced APM, we 
may consider in future rulemaking whether we should establish a process 
to extend Other Payer Advanced APM determinations for a period longer 
than a single year if we can verify that the design and structure of 
the arrangement have not changed since our previous determination.

[[Page 53870]]

    Final Action: After considering public comments, we are finalizing 
the policy as proposed. We seek additional comment regarding the 
duration of the agreements for other payer arrangements that may be 
submitted for Other Payer Advanced APM determinations and how 
frequently portions of those arrangements that are relevant to Other 
Payer Advanced APM determinations may change. We seek comment on 
whether we should allow for determinations that would be for multiple 
years, and if so, what kind of information, if any, should be submitted 
annually to allow us to determine that there have been no changes to an 
other payer arrangement that would affect our previous determination 
that the arrangement is an Other Payer Advanced APM.
(ii) Eligible Clinician Initiated Process
    In the CY 2018 Quality Payment Program proposed rule, we explained 
that we intend to create an Eligible Clinician Initiated Submission 
Form that would allow for APM Entities or eligible clinicians to submit 
the information necessary for us to determine whether a payment 
arrangement is an Other Payer Advanced APM. We proposed that, for each 
other payer arrangement an APM Entity or eligible clinician requests us 
to determine whether it is an Other Payer Advanced APM, the APM Entity 
or eligible clinician must complete and submit the Eligible Clinician 
Initiated Submission Form by the relevant Submission Deadline (82 FR 
30194 through 30195). We are finalizing these policies in section II.D. 
6.c.(1)(c) of this final rule with comment period.
    For us to make these determinations, we proposed to require that 
the APM Entity or eligible clinician submit the following information 
for each other payer arrangement:
     Arrangement name;
     Brief description of the nature of the arrangement;
     QP Performance Period for which the arrangement is 
available;
     Locations (nationwide, state, or county) where this other 
payer arrangement will be available;
     Evidence that the CEHRT criterion set forth in Sec.  
414.1420(b) is satisfied;
     Evidence that the quality measure criterion set forth in 
Sec.  414.1420(c) is satisfied, including an outcome measure;
     Evidence that the financial risk criterion set forth in 
Sec.  414.1420(d) is satisfied; and
     Other documentation as may be necessary for us to 
determine whether the other payer arrangement is an Other Payer 
Advanced APM.
    We proposed that the Eligible Clinician Initiated Submission Form 
would allow APM Entities and eligible clinicians to include descriptive 
language for each of the required information elements. We proposed to 
require the name and description of the arrangement, nature of the 
arrangement, QP Performance Period for which the arrangement is 
available, participant eligibility criteria, and, in the case of Title 
XIX arrangements only, location(s) where the arrangement will be 
available. We proposed to require evidence that all of the Other Payer 
Advanced APM criteria are met in order for us to determine that the 
arrangement is an Other Payer Advanced APM. We proposed that a 
submission for an Other Payer Advanced APM determination submitted by 
the APM Entity or eligible clinician is complete only if all of these 
information elements are submitted to us.
    We proposed to require that APM Entities or eligible clinicians 
submit documentation that supports the information they provided in the 
Eligible Clinician Initiated Submission Form and that is sufficient to 
enable us to determine whether the other payer arrangement is an Other 
Payer Advanced APM. Examples of such documentation would include 
contracts and other relevant documents that govern the other payer 
arrangement that verify each required information element, copies of 
their full contracts governing the arrangement, or some other documents 
that detail and govern the payment arrangement. In addition to 
requesting that we determine whether one or more other payer 
arrangements are Other Payer Advanced APMs for the year, APM Entities 
or eligible clinicians may also inform us that they are participating 
in an other payer arrangement that we determine to be an Other Payer 
Advanced APM for the year. To do so, we proposed that an APM Entity or 
eligible clinician would indicate, upon submission of Other Payer 
Advanced APM participation data for purposes of QP determinations, 
which Other Payer Advanced APMs they participated in during the QP 
Performance Period, and include copies of participation agreements or 
similar contracts (or relevant portions of them) to document their 
participation in those payment arrangements.
    We acknowledged that there is some burden associated with 
requesting Other Payer Advanced APM determinations. We sought comment 
on ways to reduce burden on states, payers, APM Entities, and eligible 
clinicians while still allowing us to receive the information necessary 
to make such determinations.
    We received no comments in response to these proposals.
    Final Action: We are finalizing these policies as proposed.
(b) Certification and Program Integrity
(i) Payer Initiated Process
    In the CY 2018 Quality Payment Program proposed rule, we believe 
that it is important that the information submitted by payers through 
the Payer Initiated Process is true, accurate, and complete. To that 
end, we proposed to add a new requirement at Sec.  414.1445(d) stating 
that a payer that submits information pursuant to Sec.  414.1445(c) 
must certify to the best of its knowledge that the information it 
submitted to us through the Payer Initiated Process is true, accurate, 
and complete. Additionally, we proposed that this certification must 
accompany the Payer Initiated Submission Form and any supporting 
documentation that payers submit to us through the Payer Initiated 
Process (82 FR 30195).
    We proposed to revise and clarify the monitoring and program 
integrity provisions at Sec.  414.1460. First, we proposed to modify 
Sec.  414.1460(c) to specify that information submitted by payers for 
purposes of the All-Payer Combination Option may be subject to audit by 
us. We anticipate that the purpose of any such audit would be to verify 
the accuracy of an Other Payer Advanced APM determination. We sought 
comment on how this might be done with minimal burden to payers. 
Second, we proposed at Sec.  414.1460(e)(1) to require payers who 
choose to submit information through the Payer Initiated Process to 
maintain such books, contracts, records, documents, and other evidence 
as necessary to audit an Other Payer Advanced APM determination. We 
proposed that such information must be maintained for 10 years after 
submission. We also proposed at Sec.  414.1460(e)(3) that such 
information and supporting documentation must be provided to us upon 
request. We requested comments on this proposal, including comment on 
the length of time payers typically maintain such information. We also 
sought comment on how this might be done with minimal burden to payers.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter supported CMS's proposal.
    Response: We appreciate the commenter's support of our proposal.
    Comment: Some commenters stated that 10 years is too long for 
payers to

[[Page 53871]]

maintain information submitted for the Other Payer Advanced APM 
determinations. One commenter recommended 5 years, and this commenter 
suggested that 5 years is standard business practice in the health 
insurance industry. Another commenter encouraged CMS to contemplate the 
statutes of limitation in enforcement, standards set by accreditation 
organizations, and state law record retention rules that require 
providers to retain records for 5 to 7 years. One commenter suggested a 
6 year record retention period as an alternative, and the commenter 
stated that 6-year record retention period would be more consistent 
with existing requirements including the statute of limitations under 
the False Claims Act and Civil Monetary Penalty authorities. One 
commenter noted that the Health Insurance Portability and 
Accountability Act (HIPAA) also requires a covered entity, to retain 
required documentation for 6 years. The commenter also stated that in 
2016, we proposed a 10 year record retention period for the recovery of 
overpayments, but we ultimately concluded that a 6 year record 
retention period was the most appropriate because it addressed many of 
the concerns about burden and costs to providers.
    Response: We appreciate the commenters' concerns and suggestions to 
reduce the record retention period for the Payer Initiated Process. We 
understand concerns regarding the burden associated with maintaining 
the required information for a program in which payers do not 
participate. We do not wish to lengthen existing record retention 
requirements for parties that do not participate in Medicare. 
Therefore, we are modifying our proposed record retention policy to 
require payers who choose to submit information through the Payer 
Initiated Process to maintain such books, contracts, records, 
documents, and other evidence as necessary to audit an Other Payer 
Advanced APM determination for 6 years after submission. We believe 
that our final 6 year record retention requirement reduces the burden 
on payers in a manner that is consistent with industry standards and 
adequately protects the integrity of Other Payer Advanced APM 
determinations.
    Final Action: After considering public comments, we are finalizing 
our proposed changes to Sec.  414.1445. We are finalizing our proposed 
changes to Sec.  414.1460(e)(1) as proposed, except that we are 
finalizing a 6 year record retention requirement for payers that choose 
to submit information through the Payer Initiated Process.
(ii) Eligible Clinician Initiated Process
    In the CY 2017 Quality Payment Program final rule, we finalized a 
requirement at Sec.  414.1445(b)(3) that payers must attest to the 
accuracy of information submitted by eligible clinicians (81 FR 77480). 
After publication of the CY 2017 Quality Payment Program final rule, we 
received comments from stakeholders opposing this requirement. 
Commenters suggested that payers may not have any existing relationship 
with us, that payers do not have any direct stake in the QP status of 
eligible clinicians, and that there may be operational and legal 
barriers to payers attesting to this information. In consideration of 
these comments, in the CY 2018 Quality Payment Program proposed rule, 
we proposed to eliminate the requirement at Sec.  414.1445(b)(3) that 
payers attest that the information submitted by eligible clinicians is 
accurate. Instead, we proposed that payers must certify the truth, 
accuracy, and completeness of only the information they submit directly 
to us (82 FR 30195).
    In the CY 2017 Quality Payment Program final rule, we finalized a 
requirement at Sec.  414.1460(c) that eligible clinicians and APM 
Entities must attest to the accuracy and completeness of data submitted 
to meet the requirements under the All-Payer Combination Option. We 
believe this requirement would be more appropriately placed in the 
regulatory provisions that discuss the submission of information 
related to requests for Other Payer Advanced APM determinations. 
Accordingly, we proposed to remove this requirement at Sec.  
414.1460(c) and proposed at Sec.  414.1445(d) that an APM Entity or 
eligible clinician that submits information under Sec.  414.1445(c) 
must certify to the best of its knowledge that the information it 
submitted to us is true, accurate, and complete. In the case of 
information submitted by the APM Entity, we proposed that the 
certification be made by a person with the authority to bind the APM 
Entity. We also proposed that this certification accompany the Eligible 
Clinician Initiated Submission Form and any supporting documentation 
that eligible clinicians submit to us through this process. We noted 
that under Sec.  414.1460(c), APM Entities or eligible clinicians may 
be subject to audit of the information and supporting documentation 
provided under the certification. We also proposed to add a similar 
certification requirement at Sec.  414.1440(f)(2) for QP 
determinations. We noted that we proposed to remove the last sentence 
of Sec.  414.1460(c) regarding record retention and address the record 
retention issue only in the maintenance of records provision at Sec.  
414.1460(e).
    Finally, we proposed to clarify the nature of the information 
subject to the record retention requirements at Sec.  414.1460(e). 
Specifically, we proposed that an APM Entity or eligible clinician must 
maintain such books, contracts, records, documents, and other evidence 
as necessary to enable the audit of an Other Payer Advanced APM 
determination, QP determination, and the accuracy of an APM Incentive 
Payment.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter stated that requiring APM entities and 
eligible clinicians to maintain all data submitted for a period of 10 
years poses liability, storage, and cost issues, and places a 
significant burden on eligible clinicians, particularly those in small 
practices. The commenter was also concerned that this requirement would 
place eligible clinicians and APM Entities at greater risk of exposing 
health and other information and encouraged us to contemplate the 
statutes of limitation in enforcement, standards set by accreditation 
organizations, and state law record retention rules that require 
providers to retain records for 5 to 7 years. The commenter recommended 
that CMS reduce the record retention policy to 5 years. Another 
commenter stated that 10 years is excessive and asserted that 7 years 
is a sufficient amount of time that would benefit APM Entities and 
eligible clinicians in terms of administrative burden in the storage 
and retrieval of records.
    Response: We appreciate the commenters' concerns and suggestions to 
reduce the record retention period. We understand the commenters' 
concerns with the liability, cost, and storage burdens associated with 
maintaining data and information. Therefore, we are modifying our 
proposed record retention policy at Sec.  414.1460(e)(2) to set forth a 
6 year record retention requirement. Specifically, this final rule with 
comment period requires an APM Entity or eligible clinician that 
submits information to us under Sec.  414.1445 for assessment under the 
All-Payer Combination Option to maintain such books, contracts, 
records, documents, and other evidence as necessary to enable the audit 
of an Other Payer Advanced APM determination for a period of 6 years 
from the end of the QP Performance Period or from the date of

[[Page 53872]]

completion of any audit, evaluation, or inspection, whichever is later. 
We believe that our final 6 year record retention requirement reduces 
the burden on APM Entities and eligible clinicians and is more 
consistent with HIPAA record retention requirements and other Medicare 
program requirements. In addition, we note that we are also reducing 
the record retention burden by revising Sec.  414.1460(e)(2) to remove 
the requirements to retain records for an additional period of time 
under certain circumstances. Specifically, for a special need, as 
determined by us, or for an additional 6 years from the date of any 
final resolution of a termination, dispute, or allegation of fraud or 
similar fault against an APM Entity or eligible clinician.
    Final Action: After considering public comments, we are finalizing 
the proposed changes to Sec. Sec.  414.1445(b)(3), 414.1460(c), 
414.1445(d), 414.1440(f)(2), 414.1460(c), and 414.1460(e). We note that 
the record retention requirements set forth in Sec.  414.1460(e)(2) are 
reduced. Specifically, the policies at Sec.  414.1460(e)(2) in this 
final rule with comment period provide that an APM Entity or eligible 
clinician that submits information to us under Sec.  414.1445 for 
assessment under the All-Payer Combination Option must maintain such 
books, contracts, records, documents, and other evidence as necessary 
to enable the audit of an Other Payer Advanced APM determination for a 
period of 6 years from the end of the QP Performance Period or from the 
date of completion of any audit, evaluation, or inspection, whichever 
is later. Additionally, Sec.  414.1460(e)(2) no longer require an APM 
Entity or eligible clinician to retain records for a longer period of 
time due to a special need, as determined by CMS, or for an additional 
6 years from the date of any final resolution of a termination, 
dispute, or allegation of fraud or similar fault against an APM Entity 
or eligible clinician. We are revising the regulatory text at Sec.  
414.1445(d)(2) to ensure that whoever signs the certification is 
capable of binding the party. Therefore, when a payer or APM Entity 
submits information to request an Other Payer Advanced APM 
determination, the certification must be made by an individual with the 
authority to bind the payer or APM Entity.
(iii) Outcome Measure
    In the CY 2017 Quality Payment Program final rule, we finalized at 
Sec.  414.1420(c)(3) that to meet the quality measure use criterion to 
be an Other Payer Advanced APM, the other payer arrangement must use an 
outcome measure if there is an applicable outcome measure on the MIPS 
quality measure list; but if there is no outcome measure available for 
use in the other payer arrangement, the APM Entity must attest that 
there is no applicable measure on the MIPS quality measure list. While 
we did not propose substantive changes to this policy in the CY 2018 
Quality Payment Program proposed rule, we did propose technical 
revisions to our regulations to codify this policy at Sec.  
414.1445(c)(3) and we clarify that a payer, APM entity, or eligible 
clinician must certify that there is no applicable measure on the MIPS 
quality measure list if the payment arrangement does not use an outcome 
measure.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: One commenter supported CMS's proposal.
    Response: We appreciate the commenter's support of our proposal.
    Final Action: After considering public comments, we are finalizing 
this policy as proposed at Sec.  414.1445(c)(3).
(c) Use of Information Submitted
    In the CY 2018 Quality Payment Program proposed rule, we noted that 
we intend to post, on the CMS Web site, only the following information 
about other payer arrangements that we determine are Other Payer 
Advanced APMs: The names of payers with Other Payer Advanced APMs as 
specified in either the Payer Initiated or Eligible Clinician Initiated 
Submission Form, the location(s) in which the Other Payer Advanced APMs 
are available whether at the nationwide, state, or county level, and 
the names of the specific Other Payer Advanced APMs (82 FR 30196).
    We explained that we believe that making this information publicly 
available is particularly important for Medicaid APMs and Medicaid 
Medical Home Models determined to meet the Other Payer Advanced APM 
criteria so that eligible clinicians can assess whether their Medicaid 
payments and patients would be excluded in calculations under the All-
Payer Combination Option. More generally, we believe that making this 
information publicly available would help eligible clinicians to 
identify which of their other payer arrangements are Other Payer 
Advanced APMs so they can include information on those Other Payer 
Advanced APMs in their requests for QP determinations; and to learn 
about, and potentially join, Other Payer Advanced APMs that may be 
available to them. We sought comment on whether posting this 
information would be helpful to APM Entities or eligible clinicians.
    In the CY 2017 Quality Payment Program final rule, we finalized 
that, to the extent permitted by federal law, we would maintain 
confidentiality of certain information that APM Entities or eligible 
clinicians submit for purposes of Other Payer Advanced APM 
determinations to avoid dissemination of potentially sensitive 
contractual information or trade secrets (81 FR 77478-77480).
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that, with the exception of the specific information we proposed to 
make publicly available as stated above, the information a payer 
submits to us through the Payer Initiated Process and the information 
an APM Entity or eligible clinician submits to us through the Eligible 
Clinician Initiated Process would be kept confidential to the extent 
permitted by federal law, in order to avoid dissemination of 
potentially sensitive contractual information or trade secrets.
    We sought comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Several commenters expressed concern about the submission 
of potentially proprietary or commercially sensitive information. Some 
of these commenters urged CMS to develop procedures to ensure that any 
proprietary or commercially sensitive information remains confidential, 
short of fraud and abuse reviews or other enforcement proceedings. One 
commenter requested that CMS provide examples of when our disclosure of 
such information would be lawful in this final rule. A couple of 
commenters urged CMS to provide assurance that the limited information 
to be posted on the CMS Web site will not be expanded without further 
rulemaking.
    Some commenters requested that CMS clarify whether any of the 
information that is required to be submitted would be subject to 
disclosure under the Freedom of Information Act (FOIA), and several 
commenters requested that CMS clarify that this information would be 
predesignated as falling under a FOIA exemption, either under Exemption 
4 or Exemption 5 of FOIA.
    Response: We appreciate the commenters' concerns. As we stated in 
the CY 2018 quality payment program proposed rule, we reiterate that we 
will keep confidential information submitted

[[Page 53873]]

to us for Other Payer Advanced APM determinations to the extent 
permitted by federal law.
    Additionally, we note that records that a submitter marks as 
confidential will be protected from disclosure to the extent permitted 
by federal law. Specifically, Exemption 4 of the Freedom of Information 
Act (FOIA) authorizes us to withhold trade secrets and commercial or 
financial information obtained from a person and privileged or 
confidential. (45 CFR 5.31(d)). A person who submits records to the 
government may designate part or all of the information in such records 
that they may consider to be exempt from disclosure under Exemption 4 
of the FOIA. The person may make this designation either at the time 
the records are submitted to the government or within a reasonable time 
thereafter. The designation must be in writing. Any such designation 
will expire 10 years after the records were submitted to the 
government. (45 CFR 5.41). If records provided by a submitter become 
the subject of a FOIA request, the agency will engage the submitter in 
the pre-disclosure notification process, unless the agency determines 
that the information should be withheld, or the designation of 
``confidential'' appears obviously frivolous. The pre-disclosure 
notification process can be found at 45 CFR 5.42.
    Comment: One commenter recommended that payers should have the 
opportunity, but not an obligation, to review their Other Payer 
Advanced APM information before it is posted publicly.
    Response: We appreciate the suggestion. We may take this suggestion 
into consideration in future rulemaking as we gain experience with the 
Payer Initiated and Eligible Clinician Initiated Determination 
Processes.
    Comment: One commenter suggested that cybersecurity is a 
significant consideration in both the Payer Initiated Process and 
Eligible Clinician Initiated Process. The commenter requested that CMS 
reconsider the amount and types of information required for these 
processes. The commenter also recommended strong protections in these 
processes and to make these processes public. A commenter also urged 
CMS to conduct periodic testing of database confidentiality and report 
the results to plans and health care providers.
    Response: We appreciate these concerns. We are committed to 
preventing, mitigating, and responding to cyber incidents to the extent 
possible and we will develop safeguards to protect the information 
submitted to us for purposes of the All-Payer Combination Option and 
the Quality Payment Program more generally.
    Comment: Two commenters urged CMS to ensure that public 
descriptions of Other Payer Advanced APMs do not include commercially 
sensitive information. Some commenters stated that it was unclear 
whether posting the location of Other Payer Advanced APMs will be 
helpful, suggesting that it may be more helpful to include a short 
descriptor of the model where eligible clinicians would know based on 
communication with their payer which model was applicable to their 
situation, but the public would not be able to determine any of the 
specific details of the model. Another commenter recommended that CMS 
redact individual plan identities or aggregate data before releasing 
the information publicly.
    Response: We believe that it is appropriate to limit the 
information we share about Other Payer Advanced APMs to the categories 
of information we proposed, particularly to help avoid the disclosure 
of commercially sensitive information. We believe that the limited 
categories of information that we will post on the CMS Web site will 
help avoid the disclosure of commercially sensitive information without 
the need for any redaction of information that we post on the CMS Web 
site. We also believe that posting the location of Other Payer Advanced 
APMs can help APM Entities and eligible clinicians see where Other 
Payer Advanced APMs are operating and find potential Other Payer 
Advanced APMs to join.
    Final Action: After considering public comments, we are finalizing 
our proposal that, with the exception of the specific information we 
proposed to make publicly available as stated above, the information a 
payer submits to us through the Payer Initiated Process and the 
information an APM Entity or eligible clinician submits to us through 
the Eligible Clinician Initiated Process would be kept confidential to 
the extent permitted by federal law.
(d) Use of Certified EHR Technology (CEHRT)
    In the CY 2017 Quality Payment Program final rule, we finalized 
that to be an Other Payer Advanced APM, the other payer arrangement 
must require at least 50 percent of participating eligible clinicians 
in each APM Entity to use CEHRT to document and communicate clinical 
care (81 FR 77465).
    In the CY 2018 Quality Payment Program proposed rule, we stated 
that we believe that some other payer arrangements, particularly those 
for which eligible clinicians may request determinations as Other Payer 
Advanced APMs, may only require CEHRT use at the individual eligible 
clinician level in the contract the eligible clinician has with the 
payer. We also believe that it may be challenging for eligible 
clinicians to submit information sufficient for us to determine that at 
least 50 percent of eligible clinicians under the other payer 
arrangement are required to use CEHRT to document and communicate 
clinical care (82 FR 30196).
    To address this issue, we proposed that we would presume that an 
other payer arrangement would satisfy the 50 percent CEHRT use 
criterion if we receive information and documentation from the eligible 
clinician through the Eligible Clinician Initiated Process showing that 
the other payer arrangement requires the requesting eligible 
clinician(s) to use CEHRT to document and communicate clinician 
information. We sought comment on this proposal. We also sought comment 
on what kind of requirements for CEHRT currently exist in other payer 
arrangements, particularly if they are written to apply at the eligible 
clinician level.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Two commenters supported CMS's proposal. Four commenters 
suggested that because contracts between payers and APMs may not use 
precise language identifying the use of CEHRT and clinicians have 
little control over the exact language used in these contracts, we 
should give deference to common synonyms, such as Electronic Health 
Records (EHR) and Electronic Medical Records (EMR). Two commenters also 
suggested that if CMS is not able to be more flexible in accepting 
varying contract terminology, CMS should accept the EHR vendor's 
Certified Health IT Product List (CHPL) identification number as 
verification of the use of CEHRT.
    Response: We appreciate the support of our proposal. While we 
recognize that the use of the terms EHR and EMR could amount to use of 
CEHRT in certain circumstances and will attempt to identify and 
appropriately credit instances where this is the case, we cannot give 
deference to the terms EHR or EMR alone as those terms do not 
categorically meet the definition of CEHRT in Sec.  414.1305. While a 
CHPL identification number may be evidence that CEHRT is being used, it 
is not evidence that CEHRT use is required

[[Page 53874]]

through a particular payment arrangement.
    Comment: A few commenters stated that the CERHT requirements would 
require 50 percent of participating eligible clinicians in each APM 
Entity to use CEHRT. The commenter stated that operationalizing this 
standard would be challenging, and the commenter opposed setting such a 
threshold for Other Payer Advanced APMs. The commenter also stated that 
this regulation is a more stringent requirement than what is in the 
statute. One commenter stated concern that the requirement that Other 
Payer Advanced APMs must include at least 50 percent of eligible 
clinicians to use CEHRT may limit Medicaid APM participation. The 
commenter recommended that CMS develop a pathway for states to develop 
their own EHR adoption thresholds for Medicaid APM participation. Two 
commenters recommended that CMS gradually phase in the CEHRT use 
requirement for Medicaid arrangements. One commenter recommended that 
CMS allow for flexibility with respect to this requirement.
    Response: We note that this requirement aligns with the CEHRT 
Advanced APM criterion in the Medicare Option, and we aim to align the 
Medicare Option and the All-Payer Combination Option to the extent 
possible. While it may be initially difficult to operationalize, we 
continue to believe that aligning this requirement between the two 
options is appropriate. We seek comment on this issue and whether in 
future years we should consider revising the 50 percent CEHRT use 
requirement and instead use some other standard to identify other payer 
arrangements that meet the criterion to require CEHRT use. We intend to 
monitor this requirement and may reconsider this topic in future 
rulemaking.
    Comment: One commenter stated that CMS should not require payers to 
collect, or clinicians to provide, documentation on each provider 
group's CEHRT use. The commenter stated that CMS should determine that 
an other payer arrangement meets the CEHRT use criterion if the 
contract between the payer and the provider requires use of CEHRT.
    Response: We clarify that our policy is to use the contract between 
the payer and the eligible clinician, and the requirements it specifies 
for CEHRT use, to determine whether an other payer arrangement meets 
this criterion to be an Other Payer Advanced APM. We do not require 
documentation for an individual or group's use of CEHRT.
    Final Action: After considering public comments, we are finalizing 
our proposal to presume that an other payer arrangement meets the 50 
percent CEHRT use criterion if we receive information and documentation 
from the eligible clinician through the Eligible Clinician Initiated 
Process showing that the other payer arrangement requires the 
requesting eligible clinician to use CEHRT to document and communicate 
clinician information at Sec.  414.1445(c)(2). We seek comment on 
whether we should consider revising the 50 percent CEHRT use 
requirement in future years, and if so what standard we should use in 
its place.
(8) Summary of Final Policies
    In summary, we are finalizing the following policies:
Payer Initiated Process
     We are finalizing our proposal to allow certain other 
payers, including payers with payment arrangements authorized under 
Title XIX, Medicare Health Plan payment arrangements, and payers with 
payment arrangements aligned with a CMS Multi-Payer Model to request 
that we determine whether their other payer arrangements are Other 
Payer Advanced APMs starting prior to the 2019 QP Performance Period 
and each year thereafter. We are finalizing our proposal to allow 
remaining other payers, including commercial and other private payers, 
to request that we determine whether other payer arrangements are Other 
Payer Advanced APMs starting in 2019 prior to the 2020 QP Performance 
Period, and annually each year thereafter. We will generally refer to 
this process as the Payer Initiated Other Payer Advanced APM 
Determination Process (Payer Initiated Process), and we are finalizing 
our proposal that the Payer Initiated Process would generally involve 
the same steps for each payer type for each QP Performance Period. If a 
payer uses the same other payer arrangement in other commercial lines 
of business, we are finalizing our proposal to allow the payer to 
concurrently request that we determine whether those other payer 
arrangements are Other Payer Advanced APMs as well. We are codifying 
these policies at Sec. Sec.  414.1445(a) and 414.1445(b)(1).
     We are finalizing our proposal that Other Payer Advanced 
APM determinations would be in effect for only one year at a time.
     We are finalizing our proposal that the Payer Initiated 
Process would be voluntary for all payers.
     We are finalizing our proposal that payers would be 
required to use the Payer Initiated Submission Form to request that we 
make an Other Payer Advanced APM determination. We are finalizing our 
proposal that the Submission Period opening date and Submission 
Deadline would vary by payer type to align with existing CMS processes 
for payment arrangements authorized under Title XIX, Medicare Health 
Plan payment arrangements, and payers with payment arrangements aligned 
with a CMS Multi-Payer Model to the extent possible and appropriate.
     We are finalizing that, if we determine that the payer has 
submitted incomplete or inadequate information, we would inform the 
payer and allow the payer to submit additional information no later 
than 15 business days from the date we inform the payer. For each other 
payer arrangement for which the payer does not submit sufficient 
information, we would not make a determination in response to that 
request submitted via the Payer Initiated Submission Form.
     Title XIX (Medicaid): We are finalizing that states that 
have in place a state plan under Title XIX may request that we 
determine prior to the QP Performance Period whether other payer 
arrangements authorized under Title XIX are Other Payer Advanced APMs 
under the Payer Initiated Process. We are finalizing our proposal to 
allow states to request determinations for both Medicaid fee-for-
service and Medicaid managed care plan payment arrangements. We are 
finalizing our proposal that the Submission Period for the Payer 
Initiated Process for use by states to request Other Payer Advanced APM 
determinations for other payer arrangements authorized under Title XIX 
will open on January 1 of the calendar year prior to the relevant QP 
Performance Period for which we would make Other Payer Advanced APM 
determinations. We are finalizing our proposal that the Submission 
Deadline for these submissions is April 1 of the year prior to the QP 
Performance Period for which we would make the determination.
     CMS Multi-Payer Models: We are finalizing our proposal 
that payers with other payer arrangements aligned with a CMS Multi-
Payer Model may request that we determine whether their aligned other 
payer arrangements are Other Payer Advanced APMs. We are finalizing our 
proposal that payers with other payer arrangements in a CMS Multi-Payer 
Model may request that we determine prior to the QP Performance Period 
whether those other payer arrangements are Other Payer Advanced

[[Page 53875]]

APMs. We are finalizing our proposal that payers that want to request 
that we determine whether those arrangements are Other Payer Advanced 
APMs would use the processes specified for payment arrangements 
authorized under Title XIX and Medicare Health Plan payment 
arrangements. We are finalizing our proposal that the Submission Period 
would open on January 1 of the calendar year prior to the relevant QP 
Performance Period. We are also finalizing our proposal that the 
Submission Period would close on June 1 of the calendar year prior to 
the relevant QP Performance Period. We are finalizing our proposal 
that, in CMS Multi-Payer Models where a state prescribes uniform 
payment arrangements across all payers statewide, the state would 
submit on behalf of payers in the Payer Initiated Process for Other 
Payer Advanced APMs; we would seek information for the determination 
from the state, rather than individual payers. The same Payer Initiated 
Process and timeline described above for CMS Multi-Payer Models would 
apply.
     Medicare Health Plans: We are finalizing our proposal that 
the Submission Period would begin and end at the same time as the 
annual Medicare Advantage bid timeframe. We are finalizing our proposal 
the Submission Period would begin when the bid packages are sent out to 
plans in April of the year prior to the relevant QP Performance Period. 
We are also finalizing our proposal that the Submission Deadline would 
be the annual bid deadline, which would be the first Monday in June in 
the year prior to the relevant QP Performance Period.
     Remaining Other Payers: We are finalizing our proposal 
that we will allow the remaining other payers not specifically 
addressed in proposals above, including commercial and other private 
payers that are not states, Medicare Health Plans, or payers with 
arrangements that are aligned with a CMS Multi-Payer Model, to request 
that we determine whether their other payer arrangements are Other 
Payer Advanced APMs starting prior to the 2020 QP Performance Period 
and each year thereafter.
Eligible Clinician Initiated Process
     We are finalizing our proposal that through the Eligible 
Clinician Initiated Process, APM Entities and eligible clinicians 
participating in other payer arrangements would have an opportunity to 
request that we determine for the year whether those other payer 
arrangements are Other Payer Advanced APMs. We are finalizing our 
proposal that through the Eligible Clinician Initiated Process, APM 
Entities and eligible clinicians participating in other payer 
arrangements would have an opportunity to request that we determine for 
the year whether those other payer arrangements are Other Payer 
Advanced APMs. The Eligible Clinician Initiated Process could be used 
to request determinations before the beginning of an QP Performance 
Period for other payer arrangements authorized under Title XIX. We are 
codifying these policies at Sec. Sec.  414.1445(a) and 414.1445(b)(2).
     We are finalizing our proposal that APM Entities or 
eligible clinicians would be required to use the Eligible Clinician 
Initiated Submission Form to request that we make an Other Payer 
Advanced APM determination.
     We are finalizing our proposal that if we determine that 
the APM Entity or eligible clinician has submitted incomplete or 
inadequate information, we would inform the payer and allow the payer 
to submit additional information no later than 15 business days from 
the date we inform the APM Entity or eligible clinician. For each other 
payer arrangement for which the APM Entity or eligible clinician does 
not submit sufficient information, we would not make a determination in 
response to that request submitted via the Eligible Clinician Initiated 
Submission Form.
     Title XIX (Medicaid): We are finalizing our proposal that 
for the first QP Performance Period under the All-Payer Combination 
Option, APM Entities and eligible clinicians may submit information on 
payment arrangements authorized under Title XIX to request that we 
determine whether those arrangements are Medicaid APMs or Medicaid 
Medical Home Models that meet the Other Payer Advanced APM criteria 
prior to the QP Performance Period. We are finalizing our proposal that 
APM Entities or eligible clinicians may submit an Eligible Clinician 
Initiated Submission Form for payment arrangements authorized under 
Title XIX beginning on September 1 of the calendar year prior to the QP 
Performance Period. We are also finalizing our proposal that the 
Submission Deadline is November 1 of the calendar year prior to the QP 
Performance Period.
     CMS Multi-Payer Models: We are finalizing our proposal 
that through the Eligible Clinician Initiated Process, APM Entities and 
eligible clinicians participating in other payer arrangements aligned 
with a CMS Multi-Payer Model may request that we determine whether 
those other payer arrangements are Other Payer Advanced APMs. We are 
finalizing our proposal that APM Entities or eligible clinicians may 
request Other Payer Advanced APM determinations beginning on August 1 
of the same year as the relevant QP Performance Period. We are 
finalizing that the Submission Deadline for requesting Other Payer 
Advanced APM determinations, as well as to request QP determinations 
under the All-Payer Combination Option, is December 1 of the same year 
as the relevant QP Performance Period.
     Medicare Health Plans: We are finalizing our proposal that 
through the Eligible Clinician Initiated Process, APM Entities and 
eligible clinicians participating in other payer arrangements in 
Medicare Health Plans would have an opportunity to request that we 
determine whether those other payer arrangements that are not already 
determined to be Other Payer Advanced APMs through the Payer Initiated 
Process are Other Payer Advanced APMs. We are finalizing that APM 
Entities or eligible clinicians may request Other Payer Advanced APM 
determinations beginning on August 1 of the same year as the relevant 
QP Performance Period. We are finalizing our proposal that the 
Submission Deadline for requesting Other Payer Advanced APM 
determinations, as well as to request QP determinations under the All-
Payer Combination Option, is December 1 of the same year as the 
relevant QP Performance Period.
     Remaining Other Payers: We are finalizing our proposal 
that through the Eligible Clinician Initiated Process APM Entities and 
eligible clinicians participating in other payer arrangements through 
one of these other payers is an Other Payer Advanced APM. We are 
finalizing that APM Entities or eligible clinicians may request Other 
Payer Advanced APM determinations beginning on August 1 of the same 
year as the relevant QP Performance Period. We are finalizing that the 
Submission Deadline for requesting Other Payer Advanced APM 
determinations, as well as to request QP determinations under the All-
Payer Combination Option, is December 1 of the same year as the 
relevant QP Performance Period.
Submission of Information for Other Payer Advanced APM Determinations
     We are finalizing that, for each other payer arrangement 
for which a payer requests that we make an Other Payer Advanced APM 
determination, all payers must complete and submit the

[[Page 53876]]

Payer Initiated Submission Form by the relevant Submission Deadline. We 
are finalizing that the Payer Initiated Submission Form would allow 
payers to include descriptive language for each of the required 
information elements. We are finalizing our proposal to require the 
name and description of the arrangement, nature of the arrangement, QP 
Performance Period for which the arrangement is available, participant 
eligibility criteria, and location(s) where the arrangement will be 
available so that we can verify whether eligible clinicians who may 
tell us that they participate in such arrangements are eligible to do 
so. We are finalizing the requirement that payers submit documentation 
that supports the information they provided in the Payer Initiated 
Submission Form and that is sufficient to enable us to determine 
whether the other payer arrangement is an Other Payer Advanced APM.
     We are finalizing our proposal that, for each other payer 
arrangement an APM Entity or eligible clinician requests us to 
determine whether it is an Other Payer Advanced APM, all APM Entities 
or eligible clinicians must complete and submit the Eligible Clinician 
Initiated Submission Form by the relevant Submission Deadline. We are 
finalizing that the Eligible Clinician Initiated Submission Form would 
allow APM Entities or eligible clinicians to include descriptive 
language for each of the required information elements. We are 
finalizing our proposal to require the name and description of the 
arrangement, nature of the arrangement, QP Performance Period for which 
the arrangement is available, participant eligibility criteria, and 
location(s) where the arrangement will be available so that we can 
verify whether eligible clinicians who may tell us that they 
participate in such arrangements are eligible to do so. We are 
finalizing our proposal to require that APM Entities or eligible 
clinicians submit documentation that supports the information they 
provided in the Eligible Clinician Initiated Submission Form and that 
is sufficient to enable us to determine whether the other payer 
arrangement is an Other Payer Advanced APM.
     We are finalizing our proposal that, for each other payer 
arrangement a payer requests us to determine whether it is an Other 
Payer Advanced APM, the payer must complete and submit the Payer 
Initiated Submission Form by the relevant Submission Deadline.
     We are finalizing our proposal that, for each other payer 
arrangement an APM Entity or eligible clinician requests us to 
determine whether it is an Other Payer Advanced APM, the APM Entity or 
eligible clinician must complete and submit the Eligible Clinician 
Initiated Submission Form by the relevant Submission Deadline.
     We are finalizing our proposal to add a new requirement at 
Sec.  414.1445(d) stating that a payer that submits information 
pursuant to Sec.  414.1445(c) must certify to the best of its knowledge 
that the information submitted to us through the Payer Initiated 
Process is true, accurate, and complete. Additionally, we are 
finalizing that this certification must accompany the Payer Initiated 
Submission Form and any supporting documentation that payers submit to 
us through this process.
     We are finalizing our proposed revisions to the monitoring 
and program integrity provisions at Sec.  414.1460 to ensure the 
integrity of the Payer Initiated Process. Specifically, we are 
requiring payers that choose to submit information through the Payer 
Initiated Process to maintain such books, contracts, records, 
documents, and other evidence as necessary to enable the audit of an 
Other Payer Advanced APM determination and that such information and 
supporting documentation must be maintained for a period of 6 years 
after submission and must be provided to CMS upon request. We are also 
finalizing our proposal to specify that information submitted by payers 
for purposes of the All-Payer Combination Option may be subject to 
audit by CMS.
     We are removing the requirement at Sec.  414.1445(b)(3) 
that payers must attest to the accuracy of information submitted by 
eligible clinicians, and we are also removing the attestation 
requirement at Sec.  414.1460(c). Instead, we are finalizing our 
proposal to add a requirement at Sec.  414.1445(d) that an APM Entity 
or eligible clinician that submits information pursuant to Sec.  
414.1445(c) must certify to the best of its knowledge that the 
information it submitted to us is true, accurate, and complete. We are 
also finalizing that this certification must accompany the submission, 
and in the case of information submitted by an APM Entity, the 
certification must be made by an individual with the authority to bind 
the APM Entity.
     We are removing the record retention requirement at Sec.  
414.1445(c) and in this final rule with comment period, we only address 
the record retention requirements for Other Payer Advanced APM 
determinations at Sec.  414.1460(e)(1). We are finalizing that an APM 
Entity and eligible clinician that submits information to us under 
Sec.  414.1445 for assessment under the All-Payer Combination Option 
must maintain such books, contracts, records, documents, and other 
evidence as necessary to enable the audit of an Other Payer Advanced 
APM determination for a period of 6 years from the end of the QP 
Performance Period or from the date of completion of any audit, 
evaluation, or inspection, whichever is later.
     We are finalizing that, with the exception of the specific 
information we propose to make publicly available as stated above, the 
information a payer submits to us through the Payer Initiated Process 
and the information an APM Entity or eligible clinician submits to us 
through the Eligible Clinician Initiated Process would be kept 
confidential to the extent permitted by federal law.
     We are finalizing our proposal to presume that an other 
payer arrangement would satisfy the 50 percent CEHRT use criterion if 
we receive information and documentation from the APM Entity or 
eligible clinician through the Eligible Clinician Initiated Process 
showing that the other payer arrangement requires the requesting 
eligible clinician or those in the requesting APM Entity to use CEHRT 
to document and communicate clinical information.
d. Calculation of All-Payer Combination Option Threshold Scores and QP 
Determinations
(1) Overview
    In the CY 2017 Quality Payment Program final rule, we finalized our 
overall approach to the All-Payer Combination Option (81 FR 77463). 
Beginning in 2021, in addition to the Medicare Option, an eligible 
clinician may alternatively become a QP through the All-Payer 
Combination Option, and an eligible clinician need only meet the QP 
threshold under one of the two options to be a QP for the payment year 
(81 FR 77459). We finalized that we will conduct the QP determination 
sequentially so that the Medicare Option is applied before the All-
Payer Combination Option (81 FR 77439).
    We finalized that we will calculate Threshold Scores under the 
Medicare Option through both the payment amount and patient count 
methods, compare each Threshold Score to the relevant QP and Partial QP 
Thresholds, and use the most advantageous score to make QP 
determinations (81 FR 77457). We finalized the same approach for the 
All-Payer Combination Option (81 FR 77475).

[[Page 53877]]

(2) Summary of Proposals
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
the following policies:
     We proposed to establish the All-Payer QP Performance 
Period, which would begin on January 1 and end on June 30 of the 
calendar year that is 2 years prior to the payment year. We proposed to 
add the term All-Payer QP Performance Period to Sec.  414.1305.
     We proposed to make QP determinations based on individual 
eligible clinicians' participation in Advanced APMs and Other Payer 
Advanced APMs for 2 time periods: Between January 1 through March 31 
and between January 1 through June 30 of the All-Payer QP Performance 
Period under the All-Payer Combination Option. We proposed to use data 
for the same time periods for Medicare payments or patients and that of 
other payers. We also proposed that in order for us to make a QP 
determination for an individual eligible clinician under the All-Payer 
Combination Option, the individual eligible clinician must request it 
and must submit payment amount and patient count data from other payers 
to support the QP determination.
     We proposed to notify eligible clinicians of their QP 
status under the All-Payer Combination Option as soon as practicable 
after the proposed QP Determination Submission Deadline.
     We proposed to make QP determinations under the All-Payer 
Combination Option at the individual eligible clinician level only.
     We proposed to use the individual eligible clinician 
payment amounts and patient counts for Medicare in the All-Payer 
Combination Option. We proposed that when an individual eligible 
clinician's Medicare Threshold Score calculated at the individual 
eligible clinician level would be a lower percentage than the one that 
is calculated at the APM Entity group level, we would apply a weighting 
methodology.
     We proposed that we will determine whether a state 
operates a Medicaid APM or a Medicaid Medical Home Model that has been 
determined to be an Other Payer Advanced APM at a sub-state level. We 
proposed that we will use the county level to determine whether a state 
operates a Medicaid APM or a Medicaid Medical Home Model that meets the 
Other Payer Advanced APM at a sub-state level.
     We proposed that in a state where we determine there are 
one or more Medicaid APMs or Medicaid Medical Home Models that are 
Other Payer Advanced APMs in operation, but only in certain counties, 
or only for eligible clinicians in certain specialties, we would 
further evaluate whether those Medicaid APMs or Medicaid Medical Home 
Models were available to each eligible clinician for whom we make a QP 
determination under the All-Payer Combination Option. We would identify 
the county in which the eligible clinician practices by having the 
individual eligible clinician submit information so we can identify the 
county where an individual eligible clinician saw the most patients 
during the relevant QP Performance Period when they request a QP 
determination. We also proposed that if the eligible clinician's 
practice is in a county or in a specialty in which there is no Medicaid 
APM or Medicaid Medical Home Model in operation, all of that eligible 
clinician's Medicaid payments and patients would be excluded from the 
numerator and denominator of the calculations under the payment amount 
or patient count method, respectively.
     We proposed to first make a calculation under the Medicare 
Option using all Medicare payments for the APM Entity for the payment 
amount method. If the minimum threshold score for the Medicare Option 
were met, we would make calculations under the All-Payer Combination 
Option. Because we proposed to make QP determinations at the individual 
eligible clinician level only, we proposed that under the All-Payer 
Combination Option the numerator would be the aggregate of all payments 
from all payers, except those excluded, that are made or attributable 
to the eligible clinician, under the terms of all Advanced APMs and 
Other Payer Advanced APMs. We also proposed that the denominator would 
be the aggregate of all payments from all payers, except those 
excluded, that are made or attributed to the eligible clinician.
     Because we proposed to make QP determinations at the 
individual eligible clinician level only, we proposed to count each 
unique patient one time in the numerator and one time in the 
denominator across all payers to align with our finalized policy for 
patient counts at the eligible clinician level for the patient count 
method under the All-Payer Combination Option. We proposed that the 
numerator would be the number of unique patients the eligible clinician 
furnishes services to under the terms of all of their Advanced APMs or 
Other Payer Advanced APMs. We proposed that the denominator would be 
the number of unique patients the eligible clinician furnishes services 
to under all payers, except those excluded.
     We proposed to collect the necessary payment amount and 
patient count information for QP determinations under the All-Payer 
Combination Option aggregated for the two proposed snapshot timeframes: 
From January 1 through March 31 and from January 1 through June 30. We 
proposed that APM Entities may submit this information on behalf of any 
of the eligible clinicians in the APM Entity group at the individual 
eligible clinician level. If an APM Entity or eligible clinician 
submits sufficient information for either the payment amount or patient 
count method, but not for both, we proposed to make a QP determination 
based on the one method for which we receive sufficient information.
     We proposed that APM Entities or eligible clinicians must 
submit all of the required information about the other payer 
arrangements in which they participate, including those for which there 
is a pending request for an Other Payer Advanced APM determination, as 
well as the payment amount and patient count information sufficient for 
us to make QP determinations by December 1 of the calendar year that is 
2 years to prior to the payment year, which we refer to as the QP 
Determination Submission Deadline.
     We proposed that an APM Entity or eligible clinician who 
submits information to request a QP determination under the All-Payer 
Combination Option must certify to the best of their knowledge that the 
information submitted is true, accurate and complete. When this 
information is submitted by an APM Entity, we proposed that the 
certification be made by an individual with the authority to bind the 
APM Entity. We also proposed that this certification must accompany the 
form that APM Entities or eligible clinicians submit to us when 
requesting that we make QP determinations under the All-Payer 
Combination Option.
     We proposed that APM Entities and eligible clinicians who 
submit information to us under Sec.  414.1445 for assessment under the 
All-Payer Combination Option or Sec.  414.1440 for QP determinations 
under the All-Payer Combination Option must maintain such books, 
contracts, records, documents, and other evidence as necessary to 
enable the audit of an Other Payer Advanced APM determination, QP 
determinations, and the accuracy of APM Incentive Payments for a period 
of 10 years from the end of the QP Performance Period or from the date 
of completion of any audit, evaluation, or inspection, whichever is 
later.

[[Page 53878]]

     We proposed that APM Entities and eligible clinicians who 
submit information to us under Sec.  414.1445 or Sec.  414.1440 must 
provide such information and supporting documentation to us upon our 
request.
     We proposed that, to the extent permitted by federal law, 
we will maintain confidentiality of the information that APM Entities 
or eligible clinicians submit to us for purposes of QP determinations 
under the All-Payer Combination Option, to avoid dissemination of 
potentially sensitive contractual information or trade secrets.
     We proposed that eligible clinicians who are Partial QPs 
for the year under the All-Payer Combination Option would make the 
election whether to report to MIPS.
(3) Timing of QP Determinations Under the All-Payer Combination Option
(a) All-Payer QP Performance Period and Medicare QP Performance Period
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
to establish a separate QP Performance Period for the All-Payer 
Combination Option, which would begin on January 1 and end on June 30 
of the calendar year that is 2 years prior to the payment year. We 
proposed to define this term in Sec.  414.1305 as the All-Payer QP 
Performance Period. We also proposed that the QP Performance Period for 
the Medicare Option would remain the same as previously finalized, so 
it would begin on January 1 and end on August 31 of the calendar year 
that is 2 years to the payment year. We proposed to define this term in 
Sec.  414.1305 as the Medicare QP Performance Period (82 FR 30171).
    We explained that we proposed to establish the All-Payer QP 
Performance Period because, to make QP determinations under the All-
Payer Combination Option, we first need to collect information on 
eligible clinicians' payments and patients with all other payers. And, 
in order to provide eligible clinicians with timely QP determinations 
that would enable them to make their own timely decisions for purposes 
of MIPS based on their QP status for the year, we need to collect this 
information by December 1 of the QP performance year. We expressed 
concern that eligible clinicians would not be able to submit the 
necessary payment and patient information from all of their other 
payers for the period from January 1 through August 31 before the 
December 1 QP Determination Submission Deadline. For the Medicare 
Option, we allow for a 90-day claims run out period before gathering 
the necessary payment amount and patient count information. We stated 
that we believe the same claims run out timeframe should be adopted for 
other payers, and that if we were to maintain the current QP 
Performance Period through August 31, eligible clinicians would be 
required to submit their other payer payment and patient information to 
us on or very near the end of the 90 day claims run out period, leaving 
them with little or no time to prepare the submission. We also stated 
that we believe that an additional 60 days after the claims run out is 
a reasonable amount of time for the eligible clinician to collect and 
submit the payment and patient data. We sought comment on this 
proposal, specifically as to an appropriate claims run out standard for 
other payers.
    We noted that if we retained the current QP Performance Period and 
instead delayed the QP Determination Submission Deadline to allow 
eligible clinicians time comparable to the time provided under the 
Medicare Option to fully collect and submit this information, QP 
determinations under the All-Payer Combination Option would likely not 
be complete before the end of the MIPS reporting period, which would 
undermine our goal of giving eligible clinicians information about 
their QP status prior to the end of the MIPS reporting period.
    Alternatively, we considered whether to establish the All-Payer QP 
Performance Period from January 1 through March 31 of the calendar year 
that is 2 years prior to the payment year. We sought comment on this 
alternative.
(b) Alignment of Time Periods Assessed Under the Medicare Option and 
the All-Payer Combination Option
    In the CY 2018 Quality Payment Program proposed rule, consistent 
with our proposal to make the All-Payer QP Performance Period from 
January 1 through June 30 of the calendar year that is 2 years prior to 
the payment year, we proposed to make QP determinations based on 
eligible clinicians' participation in Advanced APMs and Other Payer 
Advanced APMs between January 1 through March 31 and January 1 through 
June 30 under the All-Payer Combination Option. We also proposed that 
an eligible clinician would need to meet the relevant QP or Partial QP 
Threshold under the All-Payer Combination Option, and we would use data 
for the same time periods for Medicare payments or patients and that of 
other payers. We also proposed to align the time period assessed for 
the Medicare and other payer portions of the calculations under the 
All-Payer Combination Option because we believe that would support the 
principle that QP determinations should be based on an eligible 
clinician's performance over a single period of time (82 FR 30199 
through 30200).
    We sought comment on our proposal to create the All-Payer QP 
Performance Period and our proposals regarding alignment between time 
periods assessed under the Medicare Option and the All-Payer 
Combination Option. The following is a summary of the public comments 
received on these proposals and our responses:
    Comment: Several commenters supported CMS's proposal to create an 
All-Payer QP Performance Period. One commenter observed that this 
proposal would allow additional time for data to be analyzed and 
reviewed. One commenter also preferred a 6 month All-Payer QP 
Performance Period to a 3 month All-Payer QP Performance Period.
    Response: We appreciate the commenters' support of our proposal.
    Comment: Several commenters stated that introducing a different QP 
Performance Period for the Medicare Option and All-Payer Combination 
Option would be confusing, and these commenters recommended that CMS 
keep the QP Performance Periods for both the Medicare Option and the 
All-Payer Combination Option the same. One commenter suggested that 
aligning the two QP Performance Periods would make it easier for APM 
Entities to predict whether their eligible clinicians would become QPs. 
One commenter preferred alignment between the Medicare Option and All-
Payer Combination Option, but in the event that CMS finalized a 
different timeframe, stated that January 1 through June 30 was 
preferable to January 1 through March 31.
    Response: We appreciate these comments, and we agree that aligning 
the QP Performance Periods for the Medicare Option and All-Payer 
Combination Option would help reduce confusion among APM Entities and 
eligible clinicians. In general, it is our goal to align the policies 
under the Medicare Option and the All-Payer Combination Option to the 
extent feasible and appropriate. We also recognize that APM Entities 
and eligible clinicians may want a longer QP Performance Period so that 
more payments or patients could be included in the numerator and help 
them achieve QP status. While we remain concerned about whether APM 
Entities and eligible clinicians will be able to submit data from 
January 1 through August 31 by

[[Page 53879]]

December 1, if sufficient data is submitted by December 1, we believe 
that we will be able to notify eligible clinicians of their QP status 
before the MIPS reporting deadline.
    Comment: One commenter stated that CMS's proposal would not provide 
sufficient time to prepare and submit the information needed for a 
request for a QP determination under the All-Payer Combination Option 
and receive notification of whether the eligible clinician is a QP 
before that eligible clinician could have to begin submitting data in 
order to comply with MIPS. Another commenter noted that to be truly 
sufficient, notice of whether an eligible clinician is a QP would have 
to occur prior to the performance year, particularly if MIPS eventually 
requires reporting of quality data for the full year.
    Response: We are committed to making QP determinations and 
notifying eligible clinicians of their QP status as expeditiously as 
possible so the eligible clinicians can make appropriate decisions as 
necessary. We cannot notify an eligible clinician of QP status for a 
performance year in advance of the performance year, as we must rely on 
data from that performance year to make QP determinations. We also note 
that, in order to potentially achieve QP status through the All-Payer 
Combination Option, an eligible clinician must first achieve sufficient 
participation in an Advanced APM. We also anticipate that in many 
instances eligible clinicians who do not become QPs or Partial QPs 
under the All-Payer Combination Option would have already been required 
to submit information that would be used for MIPS scoring, particularly 
if the eligible clinician is in an Advanced APM that is also a MIPS 
APM, because the majority of information that would be required for 
MIPS would already be required under the terms of such an Advanced APM.
    Comment: Two commenters urged CMS to finalize a policy for Other 
Payer Advanced APMs under the All-Payer Combination Option similar to 
the policy CMS proposed for the Medicare Option to address the 
situation for Advanced APMs that start after or end before the QP 
Performance Period. In this circumstance, as discussed in section 
D.5.c. of this final rule with comment period, CMS proposed to only 
count claims from the date that the Advanced APM was in active testing 
if it was in active testing for at least 60 consecutive days in the QP 
Performance Period.
    Response: While we generally seek to align the policies in the 
Medicare Option and the All-Payer Combination Option, we do not 
currently believe that a similar policy is appropriate for the All-
Payer Combination Option. We believe that doing so would be burdensome 
to payers, APM Entities, and eligible clinicians because it would 
require the submission of additional information. Moreover, in order 
for an eligible clinician to become a QP through the All Payer 
Combination Option, the eligible clinician must participate in at least 
one Advanced APM and at least one Other Payer Advanced APM. It is 
unlikely that these two (or more) payment arrangements would have the 
same start and end dates, and therefore, it would be unclear which time 
period should be used when making the threshold calculations, 
especially as we make QP determinations under both the Medicare Option 
and All-Payer Combination Option based on one period of time (for 
example, January 1-March 31).
    Comment: One commenter suggested that a 3 month All-Payer QP 
Performance Period would be too short given non-clinical drivers of 
variation in performance, such as seasonality, and urged us to use an 
All-Payer QP Performance Period of at least 12 months in length to 
ensure eligible clinicians are assessed fairly. One commenter requested 
that CMS clarify how the snapshots would be used to make QP 
determinations.
    Response: We clarify that, while an eligible clinician may be able 
to attain QP status based on a 3 month period, eligible clinicians also 
have the opportunity to be assessed based on longer periods based on 
subsequent snapshots. For example, an eligible clinician could meet the 
relevant QP threshold based on performance between January 1 and March 
31. Alternatively, an eligible clinician can attain QP status based on 
performance between January 1 and June 30. We believe that establishing 
a QP Performance Period of 12 months would leave us unable to make QP 
determinations and notify certain eligible clinicians of their QP 
status in advance of the MIPS reporting deadline. We also note that our 
snapshots are for the purposes of determining QP status only. The 
snapshots do not affect the terms of any specific payment arrangement. 
In most cases, we expect that model specific assessments and incentives 
will occur over a longer period of time, such as the entire calendar 
year.
    Final Action: After considering public comments, we are not 
finalizing the proposal to create a separate All-Payer QP Performance 
Period. We will continue to align the QP Performance Period for the 
All-Payer Combination Option with the Medicare Option, so that the QP 
Performance Period for both options will begin on January 1 and end on 
August 31 of the calendar year that is 2 years prior to the payment 
year. We are finalizing this approach to reduce complexity and, as 
several commenters expressed support for, promote alignment between the 
Medicare Option and the All-Payer Combination Option. As we discuss in 
section II.D.6.d.(3)(b). of this final rule with comment period, we are 
not finalizing our proposal to create the terms and All-Payer QP 
Performance Period and Medicare QP Performance Period and we will 
instead continue to use the term QP Performance Period as finalized in 
the CY 2017 Quality Payment Program final rule in Sec.  414.1305.
    As we do for the Medicare Option, we will make QP determinations 
based on three snapshot dates: March 31, June 30, and August 31. We are 
finalizing our proposal that an eligible clinician would need to meet 
the relevant QP or Partial QP threshold under the All-Payer Combination 
Option as of one of these three dates, and to use data for the same 
time periods for Medicare and other payer payments or patients in 
making QP determinations. We recognize that it may be challenging for 
some eligible clinicians to submit data for the third snapshot, and in 
the event that an eligible clinician or APM Entity submits only 
information for either of the first two snapshots, we will make QP 
determinations on that basis. We are codifying this policy at Sec.  
414.1440(e)(3).
(c) Notification of QP Determinations Under the All-Payer Combination 
Option
    In the CY 2018 Quality Payment Program proposed rule, we explained 
that we believe it is important to provide eligible clinicians as much 
information as possible about their QP status under the Medicare Option 
prior to the proposed QP Determination Submission Deadline.
    We also believe that it is important to give eligible clinicians as 
much time as possible to prepare for MIPS reporting if necessary. We 
therefore proposed to inform eligible clinicians of their QP status 
under the All-Payer Combination Option as soon as practicable after the 
proposed QP Determination Submission Deadline (82 FR 30200).
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing this policy as proposed. We are 
codifying this policy at Sec.  414.1440(g).

[[Page 53880]]

(4) QP Determinations Under the All-Payer Combination Option
(a) QP Determinations at the Individual Eligible Clinician Level or APM 
Entity Level
    In the CY 2017 Quality Payment Program final rule, we finalized 
that, similar to the Medicare Option, we will calculate the Threshold 
Scores used to make QP determinations under the All-Payer Combination 
Option at the APM Entity group level unless certain exceptions apply 
(81 FR 77478).
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
to modify this policy and make QP determinations under the All-Payer 
Combination Option at the individual eligible clinician level only. We 
stated that we believe that there would be significant challenges 
associated with making QP determinations under the All-Payer 
Combination Option at the APM Entity group level as we finalized in the 
CY 2017 Quality Payment Program final rule (82 FR 30200).
    As we explained in the CY 2017 Quality Payment Program final rule, 
an APM Entity generally faces the risks and rewards of participation in 
an Advanced APM as a single unit and is responsible for performance 
metrics that are aggregated to the APM Entity group level as determined 
by the Advanced APM. We note that there are certain exceptions for QP 
determinations, specified in Sec.  414.1425(b)(1), for eligible 
clinicians on Affiliated Practitioner Lists. In light of these 
exceptions, we noted that we believe it is generally preferable to make 
QP determinations at the APM Entity level unless we are making QP 
determinations for eligible clinicians identified on Affiliated 
Practitioner Lists as specified at Sec.  414.1425(b)(1); or we are 
making QP determinations for eligible clinicians participating in 
multiple APM Entities, none of which reach the QP Threshold as a group 
as specified at Sec.  414.1425(c)(4) (81 FR 77439).
    However, under the All-Payer Combination Option, in the CY 2018 
Quality Payment Program proposed rule, we explained that we believe in 
many instances that the eligible clinicians in the APM Entity group we 
would identify and use to make QP determinations under the Medicare 
Option would likely have little, if any, common APM Entity group level 
participation in Other Payer Advanced APMs. The eligible clinicians in 
the same APM Entity group would not necessarily have agreed to share 
risks and rewards for Other Payer Advanced APM participation as an APM 
Entity group, particularly when eligible clinicians may participate in 
Other Payer Advanced APMs at different rates within an APM Entity group 
(or not at all).
    We also discussed our concern that eligible clinicians may 
participate in Other Payer Advanced APMs whose participants do not 
completely overlap, or do not overlap at all, with the APM Entity the 
eligible clinician is part of. Therefore, we noted that we believe that 
looking at participation in Other Payer Advanced APMs at the individual 
eligible clinician level may be a more meaningful way to assess their 
participation across multiple payers. In addition, those risks and 
rewards associated with participation in Other Payer Advanced APMs may 
vary significantly among eligible clinicians depending on the Other 
Payer Advanced APMs in which they participate. Specifically, we 
expressed concern that if we were to make All-Payer Combination Option 
QP determinations at the APM Entity level, the denominator in QP 
threshold calculations could include all other payments and patients 
from eligible clinicians who had no, or limited, Other Payer Advanced 
APM participation, thereby disadvantaging those eligible clinicians who 
did have significant Other Payer Advanced APM participation. By 
contrast, this scenario is unlikely to occur when making QP 
determinations at the APM Entity level under the Medicare Option 
because all eligible clinicians in the APM Entity group would be 
contributing to the APM Entity's performance under the Advanced APM. 
For these reasons, we stated that we believe it would be most 
appropriate to make all QP determinations under the All-Payer 
Combination Option at the individual eligible clinician level (82 FR 
30200).
    We sought comment on this proposal, specifically on the possible 
extent to which APM Entity groups in Advanced APMs could agree to be 
assessed collectively for performance in Other Payer Advanced APMs. We 
also sought comment on whether there is variation, and the extent of 
that variation, among eligible clinicians within an APM Entity group in 
their participation in other payer arrangements that we may determine 
to be Other Payer Advanced APMs. We sought comment on whether there are 
circumstances in which QP determinations should be made at the APM 
Entity group level under the All-Payer Combination Option.
    We also sought comment on whether APM Entities in Other Payer 
Advanced APMs could report this information at the APM Entity group 
level to facilitate our ability to make QP determinations at the APM 
Entity group level.
    The following is a summary of the public comments received on our 
proposal and our responses:
    Comment: Some commenters supported our proposal.
    Response: We appreciate the commenters' support of our proposal.
    Comment: Many commenters disagreed with CMS's proposal. One 
commenter expressed concerned that CMS's proposal runs counter to the 
idea that CMS would hold APM Entities collectively accountable for 
performance and risk. Another commenter disagreed with CMS's contention 
that making QP determinations at the APM Entity level made sense for 
the Medicare Option but not the All-Payer Combination Option. Some 
commenters suggested that CMS make QP determinations under the All-
Payer Combination Option at either the APM Entity or the TIN level. 
Some commenters suggested that CMS allow the APM Entity to decide 
whether QP determinations under the All-Payer Combination Option are 
made at the APM Entity or eligible clinician level. Some commenters 
urged CMS to offer a flexible approach that that allows CMS to make QP 
determinations at the APM Entity level when possible, in order to 
accommodate varying organizational structures.
    Response: We continue to believe that there will likely be 
operational challenges in making QP determinations at the APM Entity 
level in some circumstances. We also understand that making QP 
determinations at the individual eligible clinician level may be 
burdensome to APM Entities and eligible clinicians, and that there may 
be instances where making calculations at the APM Entity level is 
logical. As such, we are finalizing a flexible policy that takes into 
account the potential diversity in organizational structures while also 
trying to keep program implementation as simple and minimally 
burdensome as possible. Specifically, we are finalizing that an 
eligible clinician may request a QP determination at the individual 
eligible clinician level, and that the APM Entity may request a QP 
determination at the APM Entity level.
    Final Action: After considering public comments, and in order to 
provide eligible clinicians with the most opportunities to attain QP 
status that take into account their diverse organizational structures 
and practice patterns, we are finalizing a modified version of our 
proposal. We are finalizing that an eligible clinician may request a QP 
determination at the

[[Page 53881]]

eligible clinician level, and that an APM Entity may request a QP 
determination at the APM Entity level. We expect that this final policy 
will balance the concerns raised by commenters and the concerns that we 
expressed in the CY 2018 Quality Payment Program proposed rule. In 
cases where QP determinations are requested at the APM Entity level, we 
expect that the composition of the APM Entity will be generally 
consistent across the Advanced APM(s) and Other Payer Advanced APM(s). 
Eligible clinicians may also request QP determinations at the 
individual eligible clinician level, and we expect that this may occur 
in situations where the composition of the APM Entity is not consistent 
across the Advanced APM(s) and Other Payer Advanced APM(s).
    In the event that we receive a request for QP determination from an 
individual eligible clinician and also separately receive a QP 
determination request from that individual eligible clinician's APM 
Entity, we would make a determination at both levels. The eligible 
clinician could become a QP on the basis of either of the two 
determinations.
    We are also requesting comments on whether in future rulemaking we 
should also add a third alternative to allow QP determinations at the 
TIN level when all clinicians who have reassigned billing to the TIN 
are included in a single APM Entity. In particular, we are interested 
in whether submitting information to request QP determinations under 
the All-Payer Combination Option at the TIN level would more closely 
align with eligible clinicians' existing recordkeeping practices, and 
thereby be less burdensome.
    In the CY 2018 Quality Payment Program proposed rule, we noted that 
when an Affiliated Practitioner List defines the eligible clinicians to 
be assessed for QP determination in the Advanced APM, we make QP 
determinations under the Medicare Option at the individual level only. 
As such, we proposed that even if we did not finalize our proposal to 
conduct assessments under the All-Payer Combination Option at the 
individual eligible clinician level only, and instead adopted a 
mechanism to make QP determinations under the All-Payer Combination 
Option at the APM Entity group level, we would nonetheless assess 
eligible clinicians who meet the criteria to be assessed individually 
under the Medicare Option at the individual level only under the All-
Payer Combination Option (82 FR 30201).
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: We are finalizing this policy as proposed at Sec.  
414.1440(d)(2). Eligible clinicians who are assessed individually under 
the Medicare Option will be assessed only individually under the All 
Payer Combination Option.
(b) Use of Individual or APM Entity Group Information for Medicare 
Payment Amount and Patient Count Calculations Under the All-Payer 
Combination Option
    In the CY 2018 Quality Payment Program proposed rule, we explained 
that because we proposed to make QP determinations at the individual 
eligible clinician level only, we proposed to use the individual 
eligible clinician payment amounts and patient counts for the Medicare 
calculations in the All-Payer Combination Option. We noted that we 
believe that matching the information we use at the same level for all 
payment amounts and patient counts for both the Medicare and other 
payer portions of the calculations under the All-Payer Combination 
Option is most consistent with sections 1833(z)(2)(B)(ii) and (C)(ii) 
of the Act because these provisions require calculations that add 
together the payments or patients from Medicare and all other payers 
(except those excluded).
    We noted, however, that we would use the APM Entity group level 
payment amounts and patient counts for all Medicare Option Threshold 
Scores, unless we are making QP determinations for Affiliated 
Practitioner Lists as specified at Sec.  414.1425(b)(1) or we are 
making QP determinations for eligible clinicians participating in 
multiple APM Entities, none of which reach the QP Threshold as a group 
as specified at Sec.  414.1425(c)(4) (82 FR 30201).
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: Because we are finalizing a modified version of our 
proposal regarding the level at which we make QP determinations, we are 
finalizing a modified version of this proposal. When we make QP 
determinations at the individual eligible clinician level, we will use 
the individual eligible clinician level payment amounts and patient 
counts for the Medicare calculations in QP determinations under the 
All-Payer Combination Option. When we make QP determinations at the APM 
Entity level, we will use APM Entity level payment amounts and patient 
counts for the Medicare calculations in QP determinations under the 
All-Payer Combination Option. Eligible clinicians assessed at the 
individual eligible clinician level under the Medicare Option at Sec.  
414.1425(b)(2) will be assessed at the individual eligible clinician 
level only under the All-Payer Combination Option. We codify these 
policies at Sec.  414.1440(d)(2).
    In the CY 2018 Quality Payment Program proposed rule, we explained 
that we recognize that in many cases an individual eligible clinician's 
Medicare Threshold Scores would likely differ from the corresponding 
Threshold Scores calculated at the APM Entity group level, which would 
benefit those eligible clinicians whose individual Threshold Scores 
would be higher than the group Threshold Scores and disadvantage those 
eligible clinicians whose individual Threshold Scores are equal to or 
lower than the group Threshold Scores. In situations where eligible 
clinicians are assessed under the Medicare Option as an APM Entity 
group, and receive a Medicare Threshold Score at the group level, we 
believe that the Medicare portion of their All-Payer Combination Option 
should not be lower than the Medicare Threshold Score that they 
received by participating in an APM Entity group (82 FR 30201).
    To accomplish this outcome, we proposed a modified methodology. We 
proposed that when the eligible clinician's Medicare Threshold Score 
calculated at the individual level would be a lower percentage than the 
one that is calculated at the APM Entity group level we would apply a 
weighting methodology. This methodology would allow us to apply the APM 
Entity group level Medicare Threshold Score (if higher than the 
individual eligible clinician level Medicare Threshold Score), to the 
eligible clinician, under either the payment amount or patient count 
method, but weighted to reflect the individual eligible clinician's 
Medicare volume.
    We would multiply the eligible clinician's APM Entity group 
Medicare Threshold Score by the total Medicare payments or patients 
made to that eligible clinician as follows:

[[Page 53882]]

[GRAPHIC] [TIFF OMITTED] TR16NO17.004

    As an example of how this weighting methodology would apply under 
the payment amount method for payment year 2021, consider the following 
APM Entity group with two clinicians, one of whom participates in Other 
Payer Advanced APMs and one who does not.

                         Table 43--Weighting Methodology Example--Payment Amount Method
----------------------------------------------------------------------------------------------------------------
                                                    Medicare--                     Other payer--
                                                   advanced APM     Medicare--     advanced APM    Other payer--
                                                     payments     total payments     payments     total payments
----------------------------------------------------------------------------------------------------------------
Clinician A.....................................            $150            $200              $0            $500
Clinician B.....................................             150             800             760           1,200
APM Entity......................................             300           1,000
----------------------------------------------------------------------------------------------------------------

    In this example, the APM Entity group Medicare Threshold Score is 
$300/$1000, or 30 percent. Eligible Clinicians A and B would not be QPs 
under the Medicare Option, but Clinician B could request that we make a 
QP determination at the individual eligible clinician level under the 
All-Payer Combination Option since the APM Entity group Threshold Score 
exceeded the 25 percent minimum Medicare payment amount QP Threshold 
under the Medicare Option.
    When we calculate Clinician B's payments individually, we would 
calculate the Threshold Score as follows:
[GRAPHIC] [TIFF OMITTED] TR16NO17.005

    Because Clinician B's Threshold Score is less than the 50 percent 
QP Payment Amount Threshold, Clinician B would not be a QP based on 
this result. However, if we apply the weighting methodology, we would 
calculate the Threshold Score as follows:
[GRAPHIC] [TIFF OMITTED] TR16NO17.006

    Based upon this Threshold Score, Clinician B would be a QP under 
the All-Payer Combination Option for the year.
    We would calculate the eligible clinician's Threshold Scores both 
individually and with this weighting methodology, and then use the more 
advantageous score when making a QP determination. We noted that we 
believe that this approach promotes consistency between the Medicare 
Option and the All-Payer Combination Option to the extent possible. We 
sought comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: A few commenters supported our proposal.
    Response: We appreciate the support for our proposal.
    Comment: One commenter opposed this proposal. The commenter stated 
that it could lead to consequences such as QP status changing within a 
year. The commenter expressed concern that unless we make QP 
determinations based on participation volume from the prior year, as 
payment changes, the QP status of eligible clinicians may also change 
during the year.
    Response: We will make QP determinations under the All-Payer 
Combination Option based on performance through several intervals of 
time, at the three snapshot dates. This weighting methodology is 
designed to give an eligible clinician the more advantageous score when 
conducting QP determinations at the individual eligible clinician level 
under the All-Payer Combination Option. We emphasize that there is no 
situation in which our application of this weighting methodology would 
prevent an eligible clinician from attaining QP status. Nor would it 
ever result in QP status for an eligible clinician changing during the 
course of a year.
    Final Action: After considering public comments, we are finalizing 
this policy as proposed with one modification at Sec.  414.1440(d)(3). 
Because of our modified policy regarding the level at which we will 
calculate QP determinations under the All-Payer Combination Option, we 
clarify that we would only use this weighting methodology when QP 
determinations are made at the individual eligible clinician level and 
when the individual Threshold Scores under the Medicare Option are 
lower than the corresponding APM Entity group Threshold Scores under 
the Medicare Option.
(c) Title XIX Excluded Payments and Patients
    Sections 1833(z)(2)(B)(ii)(I)(bb) and 1833(z)(2)(C)(ii)(I)(bb) of 
the Act direct us to exclude payments made under Title XIX in a state 
where no Medicaid Medical Home Model or Medicaid APM is available under 
that state program. To carry out this exclusion, in the CY 2017 Quality 
Payment Final Rule, we finalized that for both the payment amount and 
patient count methods, Title XIX payments or patients will be excluded 
from the numerator and denominator for the QP determination unless:
    (1) A state has in operation at least one Medicaid APM or Medicaid 
Medical Home Model that is determined to be an Other Payer Advanced 
APM; and
    (2) The relevant APM Entity is eligible to participate in at least 
one of such Other Payer Advanced APMs during the QP Performance Period, 
regardless of whether the APM Entity actually participates in such 
Other Payer Advanced APMs (81 FR 77475).
    For purposes of the discussion below on the exclusion of Title XIX 
payments and patients in QP determinations, we note that when we refer 
to Medicaid Medical Home Models, we are referring to those that are 
Other Payer Advanced APMs. We also discussed that if a state operates 
such an Other Payer Advanced APM at a sub-state level such that 
eligible clinicians who do not practice in the area are not eligible to 
participate, Medicaid payments or patients should not be included in 
those eligible clinicians' QP calculations because no Medicaid Medical 
Home Model or Medicaid APM was available for their participation (81 FR 
77475).

[[Page 53883]]

    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that we will use the county level to determine whether a state operates 
a Medicaid APM or a Medicaid Medical Home Model at a sub-state level. 
We noted that we believe that the county level is appropriate as in our 
experience, the county level is the most common geographic unit used by 
states when creating payment arrangements under Title XIX at the sub-
state level. We explained that we believe that applying this exclusion 
at the county level would allow us to carry out this exclusion in 
accordance with the statute in a way that would not penalize eligible 
clinicians who have no Medicaid APMs or Medicaid Medical Home Models 
available to them (82 FR 30202). We sought comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Two commenters supported this proposal.
    Response: We appreciate the support for this proposal.
    Final Action: After considering public comments, we are finalizing 
this policy as proposed at Sec.  414.1440(a).
    In the CY 2018 Quality Payment Program proposed rule, we also 
proposed that, in states where a Medicaid APM or Medicaid Medical Home 
Model only exists in certain counties, we would exclude Title XIX data 
from an eligible clinician's QP calculations unless the county where 
the eligible clinician saw the most patients during the relevant QP 
Performance Period was a county where a Medicaid APM or Medicaid 
Medical Home Model was available. We would require eligible clinicians 
to identify and certify the county where they saw the most patients 
during the relevant QP Performance Period. If that county is not in a 
county where a Medicaid APM or Medicaid Medical Home Model was 
available during the Performance Period, then Title XIX payments would 
be excluded from the eligible clinician's QP calculations. We proposed 
this approach to ensure that, before including Title XIX payment or 
patient count information in calculating QP determinations, eligible 
clinicians have a meaningful opportunity to participate in a Medicaid 
APM or Medicaid Medical Home Model in a manner that would allow for 
both positive and negative contributions to their QP threshold score 
under the All-Payer Combination Option (82 FR 30202). We sought comment 
on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: One commenter was concerned about the burden that our 
proposal would place on eligible clinicians.
    Response: We appreciate that we are requesting eligible clinicians 
to submit more information to us, but we continue to believe that our 
proposal is the least burdensome way for us to obtain information 
necessary to determine how to apply the Medicaid exclusion at the 
county level.
    Final Action: After considering public comments, we are finalizing 
the policy as proposed.
    In addition to excluding payments based on county-level geography, 
we proposed to exclude Title XIX payments and patients from the QP 
determination calculation when the only Medicaid APMs and Medicaid 
Medical Home Models available in a given county are not available to 
the eligible clinician in question based on their specialty. We noted 
that we believe that this proposal is consistent with the statutory 
requirement to exclude Title XIX payment and patients from the 
calculations when no Medicaid APM or Medicaid Medical Home Model is 
available. In cases where participation in such a model is limited to 
eligible clinicians in certain specialties, we do not believe the 
Medicaid APM or Medicaid Medical Home Model would effectively be 
available to eligible clinicians who are not in those specialties. We 
therefore believe it would be inappropriate and inequitable to include 
Title XIX payments and patients in such eligible clinicians' QP 
determination calculations. We proposed to identify Medicaid APM or 
Medicaid Medical Home Models that are only open to certain specialties 
through questions requested of states in the Payer Initiated Process 
and of APM Entities and eligible clinicians in the Eligible Clinician 
Initiated Process. We would exclude Title XIX data from an eligible 
clinician's QP calculations unless the eligible clinician practiced 
under one of the specialty codes eligible to participate in a Medicaid 
APM or Medicaid Medical Home Model that was available in the county 
where the eligible clinician saw the most patients. We would use the 
method generally used in the Quality Payment Program to identify an 
eligible clinician's specialty or specialties (82 FR 30202 through 
30203). We sought comment on these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter expressed support for excluding Title XIX 
payments when the only Medicaid APMs and Medicaid Medical Home models 
available in a given county are not available to the eligible clinician 
in question based on their specialty.
    Response: We appreciate the support for these proposals.
    Final Action: After considering public comments, we are finalizing 
these policies as proposed at Sec.  414.1440(a)(2).
(d) Payment Amount Method
    In the CY 2017 Quality Payment Program final rule, we finalized 
that we will calculate an All-Payer Combination Option Threshold Score 
for eligible clinicians in an APM Entity using the payment amount 
method (81 FR 77476-77477). We finalized that the numerator will be the 
aggregate of all payments from all payers, except those excluded, to 
the APM Entity's eligible clinicians, or the eligible clinician in the 
event of an individual eligible clinician assessment, under the terms 
of all Other Payer Advanced APMs during the QP Performance Period. We 
finalized that the denominator will be the aggregate of all payments 
from all payers, except excluded payments, to the APM Entity's eligible 
clinicians, or the eligible clinician in the event of an individual 
eligible clinician assessment during the QP Performance Period.
    We finalized that we will calculate the Threshold Score by dividing 
the numerator value by the denominator value, which will result in a 
percent value Threshold Score. We will compare that Threshold Score to 
the relevant QP Payment Amount Threshold and the relevant Partial QP 
Payment Amount Threshold and determine the QP status of the eligible 
clinicians for the payment year (81 FR 77475).
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
to maintain the policies we finalized for the payment amount method as 
finalized, with some proposed modifications. We proposed these changes 
to facilitate the implementation of the payment amount method while 
providing eligible clinicians with some flexibility in choosing the 
timeframe for making QP determinations. To implement our proposal to 
make QP determinations at the eligible clinician level only, we 
proposed that the numerator would be the aggregate of all payments from 
all payers, except those excluded, attributable to the eligible 
clinician only, under the terms of all Advanced APMs and Other Payer 
Advanced APMs from either January 1 through March 31 or January 1 
through

[[Page 53884]]

June 30 of the QP Performance Period. We also proposed that the 
denominator would be the aggregate of all payments from all payers, 
except excluded payments, to the eligible clinician from either January 
1 through March 31, or January 1 through June 30 of the QP Performance 
Period (82 FR 30203). We sought comment on these proposals.
    The following is a summary of the public comments received on these 
proposals our responses:
    Comment: One commenter stated support for these proposals.
    Response: We appreciate the support for these proposals.
    Final Action: After considering public comments, we are finalizing 
the policy as proposed with one modification. Because we are retaining 
the January 1 through August 31 QP Performance Period for the All-Payer 
Combination Option, we will also have an August 31 snapshot date and 
thereby also make calculations based on the January 1 through August 31 
time period. We are codifying our payment amount method policy at Sec.  
414.1440(b).
(e) Patient Count Method
    In the CY 2017 Quality Payment Program final rule, we finalized 
that the Threshold Score calculation for the patient count method would 
include patients for whom the eligible clinicians in an APM Entity 
furnish services and receive payment under the terms of an Other Payer 
Advanced APM, except for those excluded. We finalized that the 
numerator would be the number of unique patients to whom eligible 
clinicians in the APM Entity furnish services that are included in the 
aggregate expenditures used under the terms of all their Other Payer 
Advanced APMs during the QP Performance Period plus the patient count 
numerator for Advanced APMs. We finalized that the denominator would be 
the number of unique patients to whom eligible clinicians in the APM 
Entity furnish services under all payers, except those excluded. We 
finalized that we will calculate the Threshold Score by dividing the 
numerator value by the denominator value, which will result in a 
percent value Threshold Score. We will compare that Threshold Score to 
the finalized QP Patient Count Threshold and the Partial QP Patient 
Count Threshold and determine the QP status of the eligible clinicians 
for the payment year. We finalized that we would count each unique 
patient one time in the numerator and one time in the denominator (81 
FR 77477-77478).
    In the CY 2018 Quality Payment Program proposed rule, we explained 
that we intend to carry out QP determinations using the patient count 
method as finalized with some proposed modifications. We proposed these 
changes to facilitate the implementation of the patient count method 
while providing eligible clinicians with some flexibility in choosing 
the timeframe for making QP determinations. To implement the proposal 
to make QP determinations at the eligible clinician level only, we 
proposed to count each unique patient one time in the numerator and one 
time in the denominator across all payers to align with our finalized 
policy for patient counts at the eligible clinician level. We proposed 
that the numerator would be the number of unique patients the eligible 
clinician furnishes services to under the terms of all of their 
Advanced APMs or Other Payer Advanced APMs from either January 1 
through March 31 or January 1 through June 30 of the QP Performance 
Period. We proposed that the denominator would be the number of unique 
patients the eligible clinician furnishes services to under all payers, 
except those excluded from either January 1 through March 31 or January 
1 through June 30 of the QP Performance Period (82 FR 30203). We sought 
comment on these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter supported our proposals.
    Response: We appreciate the commenter's support of our proposals.
    Comment: A few commenters expressed concern that the patient count 
approach could include Medicare Advantage patients in the denominator 
without commensurate addition to the numerator, which would dilute the 
patient count threshold for affected eligible clinicians. One commenter 
specifically recommended that CMS would first carry out the patient 
count method with Medicare fee-for-service alone and only add Medicare 
Advantage patient data if the eligible clinician fails to become a QP 
with just fee-for-service.
    Response: We clarify that, as we explained in the CY 2017 Quality 
Payment Program final rule, QP determinations are done sequentially, 
meaning that calculations under the Medicare Option are conducted prior 
to calculations under the All-Payer Combination Option. The All-Payer 
Combination Option is only available to eligible clinicians who have a 
sufficient amount of Advanced APM participation to qualify, but who do 
not become QPs under, the Medicare Option.
    We acknowledge that some eligible clinicians may have a significant 
number of Medicare Advantage patients but furnish care to very few of 
them through an Other Payer Advanced APM with Medicare Advantage as a 
payer. In that case, the numerator may be significantly smaller than 
the denominator, and those eligible clinicians may not meet a QP 
Threshold. However, we do not believe there is any basis for making any 
special adjustment for this situation generally, nor do we believe it 
would be appropriate to treat Medicare Advantage differently from any 
other payer in this situation.
    Final Action: After considering public comments, and in light of 
operational challenges that our proposal would pose for eligible 
clinicians or APM Entities, who would have to develop a process for 
ensuring that a single patient is not reported under two separate 
payers we are not finalizing these policies as proposed.
    We are retaining the policies as they were finalized in the CY 2017 
Quality Payment Program final rule (81 FR 77477-77478). Specifically, 
for each APM Entity, we would count each unique patient one time in the 
numerator and one time in the denominator. However, the same patient 
could be counted separately in the numerator and denominator of two 
separate payers (for example, Medicare and Medicaid for a dual 
eligible). Also, because we are retaining the January 1 through August 
31 QP Performance Period for the All-Payer Combination Option, we will 
also have an August 31 snapshot date and thereby also make calculations 
based on the January 1 through August 31 time period. We are codifying 
our patient count method policy at Sec.  414.1440(c).
(5) Submission of Information for QP Determinations Under the All-Payer 
Combination Option
    In the CY 2017 Quality Payment Program final rule, we finalized 
that either APM Entities or individual eligible clinicians must submit 
by a date and in a manner determined by us: (1) Payment arrangement 
information necessary to assess whether each other payer arrangement is 
an Other Payer Advanced APM, including information on financial risk 
arrangements, use of CEHRT, and payment tied to quality measures; (2) 
for each payment arrangement, the amounts of payments for services 
furnished through the arrangement, the total payments from the payer, 
the numbers of patients furnished any service through the arrangement 
(that is, patients for whom the eligible clinician is at risk if actual 
expenditures exceed expected expenditures), and (3) the total number

[[Page 53885]]

of patients furnished any service through the arrangement (81 FR 
77480). We also finalized that if we do not receive sufficient 
information to complete our evaluation of an other payer arrangement 
and to make QP determinations, we would not assess the eligible 
clinicians under the All-Payer Combination Option (81 FR 77480).
(a) Required Information
    In the CY 2018 Quality Payment Program proposed rule, we explained 
that in order for us to make QP determinations under the All-Payer 
Combination Option using either the payment amount or patient count 
method, we would need to receive all of the payment amount and patient 
count information: (1) Attributable to the eligible clinician through 
every Other Payer Advanced APM; and (2) for all other payments or 
patients, except from excluded payers, made or attributed to the 
eligible clinician during the QP Performance Period. We clarified that 
eligible clinicians will not need to submit Medicare payment or patient 
information for QP determinations under the All-Payer Combination 
Option.
    In the CY 2018 Quality Payment Program proposed rule, we also noted 
that we will need this payment amount and patient count information 
from January 1 through June 30 of the calendar year 2 years prior to 
the payment year. We noted will need this payment amount and patient 
count information submitted in a way that allows us to distinguish 
information from January 1 through March 31 and from January 1 through 
June 30 so that we can make QP determinations based on the two proposed 
snapshot dates (82 FR 30203 through 30204).
    We explained that to meet the need for information in a way that we 
believe minimizes reporting burden, we proposed to collect this payment 
amount and patient count information aggregated for the two proposed 
snapshot time frames: from January 1 through March 31 and from January 
1 through June 30. We sought comment on this approach, particularly as 
to the feasibility of submitting information in this way and 
suggestions on how to further minimize reporting burden. We also 
explained that alternatively, if we finalized an All-Payer QP 
Performance Period of January 1 through March 31, we would need payment 
amount and patient count information only from January 1 through March 
31. We noted that if we were to retain the current finalized QP 
Performance Period, we would need information aggregated for three 
snapshot timeframes: from January 1 through March 31, January 1 through 
June 30, and January 1 through August 31.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: One commenter expressed confusion about the timing of QP 
determinations under the All-Payer Combination Option. The commenter 
suggested that there may be a misalignment between the timing of the 
snapshots and the time period for submitting requests for Other Payer 
Advanced APM determinations.
    Response: We clarify that eligible clinicians or APM Entities may 
request Other Payer Advanced APM determinations of other payer 
arrangements that they participate in during a QP Performance Period 
after the QP Performance Period, and that to request a QP 
determination, the eligible clinician or APM Entity will need to 
include payment and patient data for the snapshots of that same year. 
We acknowledge that it is possible that an eligible clinician or APM 
Entity may submit information about a payment arrangement that we do 
not determine is an Other Payer Advanced APM, and we encourage eligible 
clinicians or APM Entities to submit this information on other payer 
arrangements earlier so that we can tell them the status of the payment 
arrangement in advance of submitting payment and patient data to avoid 
an unnecessary submission.
    Comment: One commenter suggested that CMS utilize enough snapshot 
dates to cover the entire year for both the Medicare Option and the 
All-Payer Combination Option.
    Response: We are finalizing that there will be three snapshot dates 
for both the Medicare Option and the All-Payer Combination Option, 
which are March 31, June 30, and August 31. As we discussed in the CY 
2017 Quality Payment Program final rule, we continue to believe that 
this policy of using snapshots on March 31, June 30, and August 31 
accommodates the variety of policies in different models and 
initiatives regarding the addition and removal of APM participants so 
that we capture the eligible clinicians who have meaningfully 
participated in an APM Entity in an Advanced APM during the QP 
Performance Period (81 FR 77444). We continue to believe that this 
policy, and a parallel policy for the All-Payer Combination Option, 
allows for more certainty at an earlier point in time of an eligible 
clinician's status.
    Additionally, for the All-Payer Combination Option, we are 
concerned that adding a December 31 snapshot date will leave us unable 
to notify eligible clinicians of their QP status prior to the end of 
the MIPS reporting period, particularly because we would also need to 
move the QP Determination Submission Deadline to some time period after 
December 1.
    Final Action: After considering public comments, we are finalizing 
the policy as proposed with a modification to reflect our final policy 
for the QP Performance Period in Sec.  414.1440(e). Because the length 
of the QP Performance Period for the All-Payer Combination Option is 
from January 1 through August 31 of the calendar year that is 2 years 
prior to the payment year, we will need to receive payment and patient 
information for the periods January 1 through March 31, January 1 
through June 30, and January 1 through August 31. As we discuss in 
section II.D.6.d.(3)(b) of this final rule with comment period, we 
recognize that the timing may be challenging for APM Entities or 
eligible clinicians to submit information for the August 31 snapshot 
date. If we receive information for either the March 31 or June 30 
snapshots, but not the August 31 snapshot, we will use that information 
to make QP determinations under the All-Payer Combination Option.
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that all of this payment and patient information must be submitted at 
the eligible clinician level, and not at the APM Entity group level as 
we finalized in rulemaking last year.
    We sought comment on this proposal. We received no comments in 
response to this proposal.
    Final Action: Because we are finalizing a policy where we may make 
QP determinations at either the individual eligible clinician level or 
the APM Entity level, we are finalizing a policy that payment and 
patient information must be submitted at either the individual or APM 
Entity level in order to request a QP determination. Specifically, if 
an individual eligible clinician requests a QP determination under the 
All-Payer Combination Option, payment and patient information must be 
submitted at the individual eligible clinician level. If an APM Entity 
requests a QP determination under the All-Payer Combination Option, 
payment and patient information must be submitted at the APM Entity 
level. We are codifying this policy at Sec.  414.1440(e).
    In the CY 2018 Quality Payment Program proposed rule, to minimize 
reporting burden on individual eligible clinicians and to allow 
eligible clinicians to submit information to us as efficiently as 
possible, we proposed to

[[Page 53886]]

allow eligible clinicians to have APM Entities submit information for 
them at the individual eligible clinician level on behalf of any of the 
eligible clinicians in the APM Entity group. We sought comments on 
these proposals, particularly regarding the feasibility of APM Entities 
reporting this information for some or all of the eligible clinicians 
in the APM Entity group. Additionally, we proposed that if an APM 
Entity or eligible clinician submits sufficient information only for 
the payment amount or patient count method, but not for both, we will 
make a QP determination based on the one method for which we receive 
sufficient information (82 FR 30204). We noted that we believe that the 
proposal was consistent with our overall approach, particularly because 
we finalized in the CY 2017 Quality Payment Program final rule that we 
will use the more advantageous of the Threshold Scores to make QP 
determinations (81 FR 77475). We clarified that APM Entities or 
eligible clinicians can submit information to allow us to use both the 
payment amount and patient count methods.
    To facilitate and ease burden for information submissions, we also 
proposed to create a form that APM Entities or eligible clinicians 
would be able to use to submit this payment amount and patient count 
information. APM Entities and eligible clinicians would be required to 
use this form for submitting the payment and patient information.
    We sought comment on these proposals.
    The following is a summary of comments we received on these 
proposals and our responses:
    Comment: One commenter supported CMS's proposal to allow for APM 
Entities to report on behalf of eligible clinicians, and one commenter 
requested that any reporting requirements minimize burden on eligible 
clinicians.
    Response: We appreciate the commenter's support of our proposal. 
One of our goals is to reduce burden to the extent possible.
    Comment: One commenter stated that CMS should make the forms to 
collect this information available well in advance and that they should 
be subject to public comment to allow payers to clarify terminology and 
definitions and help ensure that information submitted to us is 
appropriate. A few commenters requested that CMS release subregulatory 
guidance so that APM entities and eligible clinicians will know what to 
collect and submit in order for CMS to make a QP determination under 
the All-Payer Combination Option. The commenter requested that CMS 
provide guidance on the format and the submission mechanism and 
estimated expense and time for clinicians to compile payment and 
patient count information.
    Response: We appreciate the comments. We intend to create a form 
that will be available for public comment through the Paperwork 
Reduction Act (PRA) process and to release subregulatory guidance to 
facilitate the submission of this information.
    Comment: One commenter suggested that the onus on submitting 
relevant payment information should be on the payer, especially as 
eligible clinicians are already overburdened and that payers have a 
better understanding of what information CMS would need and would be in 
a better position to provide that information than eligible clinicians.
    Response: We encourage payers to assist APM Entities and eligible 
clinicians in compiling and submitting data, but we have no clear basis 
for compelling payers to submit, or holding payers accountable to the 
accuracy of, the necessary information. We also note that no single 
payer is likely to have all of the necessary information for any given 
clinician, as such information will typically involve payment and 
patient counts across multiple payers.
    Final Action: After considering public comments, we are finalizing 
our proposal to allow eligible clinicians to have APM Entities submit 
information for them at the individual eligible clinician level on 
behalf of any of the eligible clinicians in the APM Entity group.
    We are also finalizing our proposal that if an APM Entity or 
eligible clinician submits sufficient information only for the payment 
amount or patient count method, but not for both, we will make a QP 
determination based on the one method for which we receive sufficient 
information. We are also finalizing our proposal to create a form that 
APM Entities or eligible clinicians would be able to use to submit this 
payment amount and patient count information.
(b) QP Determination Submission Deadline
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that APM Entities or eligible clinicians must submit all of the 
required information about the Other Payer Advanced APMs in which they 
participate, including those for which there is a pending request for 
an Other Payer Advanced APM determination, as well as the payment 
amount and patient count information sufficient for us to make QP 
determinations by December 1 of the calendar year that is 2 years to 
prior to the payment year, which we refer to as the QP Determination 
Submission Deadline (82 FR 30204).
    In the CY 2017 Quality Payment Program final rule, we finalized 
that without sufficient information we will not make QP determinations 
under the All-Payer Combination Option (81 FR 77480). As such, we will 
not make QP determinations for an eligible clinician under the All-
Payer Combination Option if we do not receive information sufficient to 
make a QP determination under either the payment amount or patient 
count method by the QP Determination Submission Deadline.
    We sought comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: One commenter supported CMS's proposal and encouraged CMS 
to finalize it so that QP determinations could be made in time to 
notify eligible clinicians of their QP status prior to the MIPS 
reporting deadline.
    Response: We appreciate the support of our proposal, and we agree 
that it is important for us to develop this timeline in a way that 
allows for QP determinations to be made and notifications to be sent 
prior to the MIPS reporting deadline.
    Comment: Two commenters expressed concern that CMS seemed to be 
requesting that the requests for determination must be submitted by 
September 1 in order to be notified of their QP status prior to the 
MIPS reporting deadline.
    Response: We clarify that September 1 is the deadline for an APM 
Entity or eligible clinician to choose to submit information regarding 
any payment arrangements they participate in so that they can receive 
Other Payer Advanced APM determinations for those arrangements prior to 
submitting payment and patient data. If eligible clinicians and APM 
Entities are made aware in advance that certain arrangements are not 
Other Payer Advanced APMs, they will know with more specificity what 
payment or patient information to submit. The deadline for submitting 
payment amount and patient count data so that a QP determination can be 
made under the All-Payer Combination Option is December 1.
    Comment: One commenter was concerned that this timeline would place 
APM entities and eligible clinicians in an awkward position of not 
knowing until the very end of the

[[Page 53887]]

performance year, or even later, whether they need to report to MIPS. 
They suggested that CMS consider either some form of deemed status from 
one year to another. For example, data from 2017 could be used to 
establish QP status for 2018 or CMS could adopt some earlier deadline 
for part-year data submission such as first 6 months of the year, 
reportable starting July 1 of that year.
    Response: We appreciate the comments. We acknowledge that the 
timeframe between QP determinations and MIPS reporting is narrow, and 
we have designed this timeline to try to provide as much advance notice 
to eligible clinicians as possible. We will monitor how this timeline 
develops and may consider changes in future rulemaking.
    Final Action: After considering public comments, we are finalizing 
our proposal that APM Entities or eligible clinicians must submit all 
of the required information about the Other Payer Advanced APMs in 
which they participate, including those for which there is a pending 
request for an Other Payer Advanced APM determination, as well as the 
payment amount and patient count information sufficient for us to make 
QP determinations by December 1 of the calendar year that is 2 years to 
prior to the payment year, which we refer to as the QP Determination 
Submission Deadline. We are codifying this policy at Sec.  
414.1440(e)(4).
(c) Certification and Program Integrity
    In the CY 2018 Quality Payment Program proposed rule, we proposed 
that a new requirement be added at Sec.  414.1440(f)(2) stating that 
the APM Entity or eligible clinician that submits information to 
request a QP determination under the All-Payer Combination Option must 
certify to the best of its knowledge that the information that they 
submitted to us is true, accurate, and complete. If the information is 
submitted by an APM Entity, we proposed that the certification must be 
made by an individual with the authority to legally bind the APM 
Entity. This certification would accompany the Eligible Clinician 
Initiated Submission Form, which both eligible clinicians and APM 
Entities use for the Eligible Clinician Initiated Process (82 FR 
30204). We sought comment on these proposals.
    We proposed to revise the monitoring and program integrity 
provisions at Sec.  414.1460 to further promote the integrity of the 
All-Payer Combination Option. In the CY 2017 Quality Payment Program 
final rule, we finalized at Sec.  414.1460(e) that an APM Entity or 
eligible clinician that submits information to us under Sec.  414.1445 
for assessment under the All-Payer Combination Option must maintain 
such books contracts records, documents, and other evidence for a 
period of 10 years from the final date of the QP Performance Period or 
from the date of completion of any audit, evaluation, or inspection, 
whichever is later (81 FR 77555). We also finalized at Sec.  
414.1460(c) that eligible clinicians and APM Entities must maintain 
copies of any supporting documentation related to the All-Payer 
Combination Option for at least 10 years (81 FR 77555). We propose to 
revise Sec.  414.1460(e) to apply to information submitted to us under 
Sec.  414.1440 for QP determinations. We also proposed to add paragraph 
(3) to Sec.  414.1460(e) stating that an APM Entity or eligible 
clinician who submits information to us under Sec.  414.1445 or Sec.  
414.1440 must provide such information and supporting documentation to 
us upon our request. We sought comments on these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter stated that the 10-year record retention 
period is overly burdensome on eligible clinicians. This commenter also 
stated that the 10-year record retention period is based on the outer 
limit of the False Claims Act, and the commenter suggested that our 
proposed timeframe is unreasonable. The commenter encouraged CMS to use 
either a 3 or 6 year period.
    Response: We appreciate the commenters' concerns and suggestions to 
reduce the record retention period. For the reasons set forth in 
section II.D.6.c.(7)(b) of this final rule with comment period, we are 
finalizing a 6 year record retention requirement. In addition, we have 
modified the regulation text to remove language that would require 
parties to retain records for a longer period of time in certain 
circumstances.
    Final Action: After considering public comments, we are finalizing 
the proposed changes to Sec.  414.1440(f)(2) and Sec.  414.1460(e) 
without modification, except that the record retention requirements set 
forth in Sec.  414.1460(e)(2) are reduced. Specifically, the policies 
at Sec.  414.1460(e)(2) in this final rule provide that an APM Entity 
or eligible clinician that submits information to us under Sec.  
414.1440 for QP determinations must maintain such books, contracts, 
records, documents, and other evidence as necessary to enable the audit 
of an QP determinations and the accuracy of APM Incentive Payments for 
a period of 6 years from the end of the QP Performance Period or from 
the date of completion of any audit, evaluation, or inspection, 
whichever is later. Additionally, Sec.  414.1460(e)(2) no longer 
require an APM Entity or eligible clinician to retain records for a 
longer period of time based on a special need, as determined by us, or 
for an additional 6 years from the date of any final resolution of a 
termination, dispute, or allegation of fraud or similar fault against 
an APM Entity or eligible clinician.
(d) Use of Information
    In the CY 2017 Quality Payment Program final rule, we finalized 
that, to the extent permitted by federal law, we will maintain 
confidentiality of the information and data that APM Entities and 
eligible clinicians submit to support Other Payer Advanced APM 
determinations in order to avoid dissemination of potentially sensitive 
contractual information or trade secrets (81 FR 77479-77480).
    We believe that it is similarly appropriate for us to maintain the 
confidentiality of information submitted to us for the purposes of QP 
determinations to the extent permitted by federal law. Therefore, we 
proposed that, to the extent permitted by federal law, we will maintain 
confidentiality of the information that APM Entities or eligible 
clinicians submit to us for purposes of QP determinations under the 
All-Payer Combination Option.
    The following is a summary of the public comments we received on 
this proposal and our responses:
    Comment: One commenter urged us to keep commercially sensitive 
information confidential.
    Response: We reiterate that we will maintain confidentiality of the 
information that APM Entities or eligible clinicians submit to us for 
purposes of QP determinations under the All-Payer Combination Option to 
the full extent permitted by federal law.
    Additionally, we also note that records that a submitter marks as 
confidential will be protected from disclosure to the extent permitted 
by federal law. Specifically, Exemption 4 of the Freedom of Information 
Act (FOIA) authorizes our agency to withhold trade secrets and 
commercial or financial information obtained from a person and 
privileged or confidential. (45 CFR 5.31(d)). A person who submits 
records to the government may designate part or all of the information 
in such records that they may consider to be exempt from disclosure 
under Exemption 4 of

[[Page 53888]]

the FOIA. The person may make this designation either at the time the 
records are submitted to the government or within a reasonable time 
thereafter. The designation must be in writing. Any such designation 
will expire 10 years after the records were submitted to the government 
(45 CFR 5.41). If records provided by a submitter become the subject of 
a FOIA request, the agency will engage the submitter in the pre-
disclosure notification process, unless the agency determines that the 
information should be withheld, or the designation of ``confidential'' 
appears obviously frivolous. The pre-disclosure notification process 
can be found at 45 CFR 5.42.
    Final Action: After considering public comments, we are finalizing 
the policy as proposed.
(6) Examples
    In the CY 2018 Quality Payment Program proposed rule, to illustrate 
how we would conduct QP determinations under the All-Payer Combination 
Option, we provided examples where an eligible clinician is in a 
Medicare ACO Model that we have determined to be an Advanced APM, a 
commercial ACO arrangement, and a Medicaid APM from January 1 through 
June 30, 2019 (82 FR 30205 through 30206). Because we are finalizing 
that one of the ways in which we will make QP determinations is at the 
individual eligible clinical level, this example illustrates how we 
will make individual eligible clinician level QP determinations.
    In this example, we would use the information below to determine 
that eligible clinician's QP status for payment year 2021. We would 
calculate the Threshold Scores for the APM Entity group in the Advanced 
APM under the Medicare Option. For the payment amount method, as we 
show in Table 44 below, the APM Entity group would not attain QP status 
under the Medicare Option, which for payment year 2021 requires a QP 
payment amount Threshold Score of 50 percent. The APM Entity group 
would also fail to attain Partial QP status under the Medicare Option, 
which for payment year 2021 requires a Partial QP payment amount 
Threshold Score of 40 percent. For the patient count method, as we show 
in Table 45, the APM Entity group would not attain QP status under the 
Medicare Option, which for payment year 2021 requires a QP patient 
count Threshold Score of 35 percent. The APM Entity group would not 
attain Partial QP status under the Medicare Option, which for payment 
year 2021 requires a Partial QP patient count Threshold Score of 25 
percent.

          Table 44--All-Payer Combination Option Example--Payment Amount Method for Eligible Clinicians
----------------------------------------------------------------------------------------------------------------
                                                                                  Total payments
                                                                    Payments to      to group/
                                                                  group/eligible     eligible        Threshold
                 Payer                            Level            clinician by    clinician by        score
                                                                     payer (in       payer (in     (percentage)
                                                                     dollars)        dollars)
----------------------------------------------------------------------------------------------------------------
                                                 Medicare Option
----------------------------------------------------------------------------------------------------------------
Advanced APM (Medicare)...............  APM Entity Group........         300,000       1,000,000              30
----------------------------------------------------------------------------------------------------------------
                                          All-Payer Combination Option
----------------------------------------------------------------------------------------------------------------
Advanced APM (Medicare)...............  Eligible Clinician......          20,000          50,000  ..............
Other Payer Advanced APM (Commercial).  Eligible Clinician......          20,000          50,000  ..............
Medicaid APM..........................  Eligible Clinician......          80,000         100,000  ..............
                                                                 -----------------------------------------------
    Totals for All-Payer Combination    Eligible Clinician......         120,000         200,000              60
     Option.
----------------------------------------------------------------------------------------------------------------


          Table 45--All-Payer Combination Option Example--Patient Count Method for Eligible Clinicians
----------------------------------------------------------------------------------------------------------------
                                                                                  Total patients
                                                                    Patients of      of group/       Threshold
                 Payer                            Level           group/eligible     eligible          score
                                                                   clinician by    clinician by    (percentage)
                                                                       payer           payer
----------------------------------------------------------------------------------------------------------------
                                                 Medicare Option
----------------------------------------------------------------------------------------------------------------
Advanced APM (Medicare)...............  APM Entity Group........           2,200          10,000              22
----------------------------------------------------------------------------------------------------------------
                                          All-Payer Combination Option
----------------------------------------------------------------------------------------------------------------
Advanced APM (Medicare)...............  Eligible Clinician......             200           1,000  ..............
Other Payer Advanced APM (Commercial).  Eligible Clinician......             100             500  ..............
Medicaid APM..........................  Eligible Clinician......             500           1,000  ..............
                                                                 -----------------------------------------------
    Totals for All-Payer Combination    Eligible Clinician......             800           2,500              32
     Option.
----------------------------------------------------------------------------------------------------------------

    The APM Entity group did not attain QP or Partial QP status under 
either the payment amount or patient count method under the Medicare 
Option. However, because under both methods of calculation, the APM 
Entity group meets or exceeds the required Medicare threshold for the 
year under the All-Payer Combination Option of 25 percent and 20 
percent, respectively, eligible clinicians within the APM Entity group 
would be eligible to obtain QP status through the All-Payer Combination 
Option. The eligible clinicians in the APM Entity group would have been

[[Page 53889]]

notified of this result as we share information on a regular basis on 
their QP status under each snapshot. For payment year 2021, the 
eligible clinicians in this APM Entity group would submit their payment 
amount or patient count data from all payers to calculate their 
Threshold Score under the All-Payer Combination Option.
    In this example above where we make the calculation at the 
individual eligible clinician level, the eligible clinician score 
exceeds the QP payment amount Threshold under the All-Payer Combination 
Option, which for payment year 2021 is 50 percent, but the eligible 
clinician only exceeds the Partial QP patient count Threshold under the 
All-Payer Combination Option, which for payment year 2021 is 25 
percent. We would use the more advantageous score, so the eligible 
clinician would be a QP for payment year 2021.
    Alternatively, if we were to use the APM Entity weighting 
methodology for calculation of a Threshold Score using the payment 
amount method as described in the proposed rule, we would apply the 
weighted methodology as follows:
[GRAPHIC] [TIFF OMITTED] TR16NO17.007

[GRAPHIC] [TIFF OMITTED] TR16NO17.008

    The eligible clinician would obtain a Threshold Score of 58 
percent. This would be slightly below the Threshold Score obtained from 
the individual eligible clinician payment count calculation, but it 
would still exceed the QP payment amount threshold of 50 percent under 
the All-Payer Combination Option. Based upon this Threshold Score, the 
eligible clinician would be a QP under the All-Payer Combination 
Option.
    Because we are finalizing that we will in certain circumstances 
make QP determinations under the All-Payer Combination Option at the 
APM Entity level, we provide an example below of how we will make QP 
determinations at the APM Entity group level under the All-Payer 
Combination Option based on information shown in Tables 46 and 47. The 
APM Entity group score exceeds the QP payment amount Threshold under 
the All-Payer Combination Option, or 50 percent, but the APM Entity 
group only exceeds the Partial QP patent count Threshold under the All-
Payer Combination Option, which for payment year 2021 is 25 percent. 
Again, we would use the more advantageous score, so the eligible 
clinician would be a QP for the payment year 2021.

              Table 46--All-Payer Combination Option Example--Payment Amount Method for APM Entity
----------------------------------------------------------------------------------------------------------------
                                                                                  Total payments
                                                                    Payments to     to group by      Threshold
                 Payer                            Level           group by payer     payer (in         score
                                                                   (in dollars)      dollars)      (percentage)
----------------------------------------------------------------------------------------------------------------
                                                 Medicare Option
----------------------------------------------------------------------------------------------------------------
Advanced APM (Medicare)...............  APM Entity Group........         300,000       1,000,000              30
----------------------------------------------------------------------------------------------------------------
                                          All-Payer Combination Option
----------------------------------------------------------------------------------------------------------------
Advanced APM (Medicare)...............  APM Entity Group........         300,000       1,000,000  ..............
Other Payer Advanced APM (Commercial).  APM Entity Group........         200,000         500,000  ..............
Medicaid APM..........................  APM Entity Group........         800,000       1,000,000  ..............
                                                                 -----------------------------------------------
    Totals for All-Payer Combination    APM Entity Group........       1,300,000       2,500,000              52
     Option.
----------------------------------------------------------------------------------------------------------------


               Table 47--All-Payer Combination Option Example--Patient Count Method for APM Entity
----------------------------------------------------------------------------------------------------------------
                                                                                  Total patients     Threshold
                 Payer                            Level             Patients of     of group by        score
                                                                  group by payer       payer       (percentage)
----------------------------------------------------------------------------------------------------------------
                                                 Medicare Option
----------------------------------------------------------------------------------------------------------------
Advanced APM (Medicare)...............  APM Entity Group........           2,200          10,000              22
----------------------------------------------------------------------------------------------------------------
                                          All-Payer Combination Option
----------------------------------------------------------------------------------------------------------------
Advanced APM (Medicare)...............  APM Entity Group........           2,200          10,000  ..............
Other Payer Advanced APM (Commercial).  APM Entity Group........           1,000           5,000  ..............
Medicaid APM..........................  APM Entity Group........           5,000          10,000  ..............
                                                                 -----------------------------------------------
    Totals for All-Payer Combination    APM Entity Group........           8,200          25,000              33
     Option.
----------------------------------------------------------------------------------------------------------------


[[Page 53890]]

(7) Partial QP Election to Report to MIPS
    In the 2017 Quality Payment Program final rule, we finalized under 
the Medicare Option that, in the cases where the QP determination is 
made at the individual eligible clinician level, if the eligible 
clinician is determined to be a Partial QP, the eligible clinician will 
make the election whether to report to MIPS and then be subject to MIPS 
reporting requirements and payment adjustments (81 FR 77449). To 
promote alignment with the Medicare Option and to simplify requirements 
when possible, we proposed that eligible clinicians who are Partial QPs 
for the year under the All-Payer Combination Option would make the 
election whether to report to MIPS and therefore be subject to MIPS 
reporting requirements and payment adjustments. We sought comment on 
this proposal. We received no comments in response to this proposal.
    Final Action: We are finalizing this policy as proposed.
(8) Summary of Final Policies
    In summary, we are finalizing the following policies:
     We are finalizing at Sec.  414.1305 that the QP 
Performance Period begins on January 1 and ends on August 31 of the 
calendar year that is 2 years prior to the payment year applies to the 
All-Payer Combination Option. We are not finalizing the terms All-Payer 
QP Performance Period and Medicare QP Performance Period.
     We are finalizing that we will make QP determinations 
based on eligible clinicians' participation in Advanced APMs and Other 
Payer Advanced APMs for 3 time periods: between January 1 through March 
31, between January 1 through June 30, and between January 1 through 
August 31 of the QP Performance Period under the All-Payer Combination 
Option. We are finalizing that we will use data for the same time 
periods for Medicare payments or patients and that of other payers. We 
are codifying this policy at Sec.  414.1440(d)(1).
     We are finalizing that we will notify eligible clinicians 
of their QP status under the All-Payer Combination Option as soon as 
practicable after the QP Determination Submission Deadline. We are 
codifying this policy at Sec.  414.1440(g).
     We are finalizing that eligible clinicians may request 
that we make QP determinations at the individual eligible clinician 
level and that APM Entities may request that we make QP determinations 
at the APM Entity level. We are codifying this policy at Sec.  
414.1440(e).
     We are finalizing that we will use either individual 
eligible clinician level or APM Entity level payment amounts and 
patient counts for Medicare in the All-Payer Combination Option, 
depending on which level the request for QP determination is made. We 
are finalizing that when the eligible clinician's Medicare Threshold 
Score calculated at the individual eligible clinician level would be a 
lower percentage than the one that is calculated at the APM Entity 
level, and the eligible clinician requested that we make QP 
determinations at the individual eligible clinician level, we would 
apply the weighting methodology. We are codifying this policy at Sec.  
414.1440(d)(3).
     We are finalizing that we will determine whether a state 
operates a Medicaid APM or a Medicaid Medical Home Model that has been 
determined to be an Other Payer Advanced APM at a sub-state level. We 
are finalizing that we will use the county level to determine whether a 
state operates a Medicaid APM or a Medicaid Medical Home Model that 
meets the Other Payer Advanced APM at a sub-state level. We are 
codifying our policies pertaining to Title XIX excluded payments and 
patients at Sec.  414.1440(a).
     We are finalizing that in a state where we determine there 
are one or more Medicaid APMs or Medicaid Medical Home Models that are 
Other Payer Advanced APMs in operation, but only in certain counties, 
or only for eligible clinicians in certain specialties, we would 
further evaluate whether those Medicaid APMs or Medicaid Medical Home 
Models were available to each eligible clinician for whom we make a QP 
determination under the All-Payer Combination Option. We will identify 
the county in which the eligible clinician practices by having the 
eligible clinician submit that information to identify the county where 
they saw the most patients during the relevant QP Performance Period 
when they request a QP determination. We are also finalizing that if 
the eligible clinician's practice is in a county, or in a specialty, in 
which there is no Medicaid APM or Medicaid Medical Home Model in 
operation, all of that eligible clinician's Medicaid payments and 
patients would be excluded from the numerator and denominator of the 
calculations under the payment amount or patient count method, 
respectively. We are also finalizing that we will identify Medicaid 
APMs or Medicaid Medical Home Models that are only open to certain 
specialties through questions requested of states in the Payer 
Initiated Process and of eligible clinicians in the Eligible Clinician 
Initiated Process. We would use the method generally used in the 
Quality Payment Program to identify an eligible clinician's specialty 
or specialties. We are codifying our policies pertaining to Title XIX 
excluded payments and patients at Sec.  414.1440(a).
     For the payment amount method, we are finalizing that we 
would first make a calculation under the Medicare Option. If the 
minimum threshold score for the Medicare Option were met so that the 
eligible clinician could become a QP under the All-Payer Combination 
Option, and did not become a QP under the Medicare Option, we would 
make calculations under the All-Payer Combination Option. We are 
finalizing that under the All-Payer Combination Option the numerator 
would be the aggregate of all payments from all payers, except those 
excluded, that are made or attributable to the eligible clinician, 
under the terms of all Advanced APMs and Other Payer Advanced APMs. We 
are also finalizing that the denominator would be the aggregate of all 
payments from all payers, except those excluded, that are made or 
attributed to the eligible clinician. We are codifying our payment 
amount method policy at Sec.  414.1440(b).
     For the patient count method under the All-Payer 
Combination Option, we are not finalizing our proposal and we are 
maintaining the policy that we finalized in the CY 2017 Quality Payment 
Program final rule. Specifically, for each APM Entity, we would count 
each unique patient one time in the numerator and one time in the 
denominator. However, the same patient could be counted separately in 
the numerator and denominator of two separate payers (for example, 
Medicare and Medicaid). We are codifying our patient count policy at 
Sec.  414.1440(c).
     We are finalizing that we will require APM Entities or 
eligible clinicians to submit the necessary payment amount and patient 
count information for QP determinations under the All-Payer Combination 
Option aggregated for the two proposed snapshot timeframes: From 
January 1 through March 31, from January 1 through June 30, and from 
January 1 through August 31. We are finalizing that APM Entities may 
submit this information on behalf of any of the eligible clinicians in 
the APM Entity group at the individual eligible clinician level. If we 
receive information for some, but not all of the snapshots dates, we 
will use that information to make QP determinations under the All-Payer 
Combination Option. We are codifying this policy at Sec.  414.1440(e).

[[Page 53891]]

     We are finalizing that if an APM Entity or eligible 
clinician submits sufficient information for either the payment amount 
or patient count method, but not for both, we will make a QP 
determination based on the one method for which we receive sufficient 
information. We are codifying this policy at Sec. Sec.  414.1440(e)(3) 
and 414.1440(f)(1).
     We are finalizing that APM Entities or eligible clinicians 
must submit all of the required information about the Other Payer 
Advanced APMs in which they participate, including those for which 
there is a pending request for an Other Payer Advanced APM 
determination, as well as the payment amount and patient count 
information sufficient for us to make QP determinations by December 1 
of the calendar year that is 2 years to prior to the payment year, 
which we refer to as the QP Determination Submission Deadline. We are 
codifying this policy at Sec.  414.1440(e)(4).
     We are finalizing that an APM Entity or eligible clinician 
that submits information to request a QP determination under the All-
Payer Combination Option must certify to the best of its knowledge that 
the information submitted is true, accurate and complete. In the case 
of information submitted by the APM Entity, we are finalizing that the 
certification needs to be made by an individual with the authority to 
bind the APM Entity. We are also finalizing that this certification 
must accompany the form that APM Entities or eligible clinicians submit 
to us when requesting that we make QP determinations under the All-
Payer Combination Option. We are codifying this policy at Sec.  
414.1440(f)(2).
     We are finalizing that an APM Entity or eligible clinician 
that submits information to us under Sec.  414.1440 for QP 
determinations must maintain such books, contracts, records, documents, 
and other evidence as necessary to enable the audit of QP 
determinations and the accuracy of APM Incentive Payments for a period 
of 6 years from the end of the QP Performance Period or from the date 
of completion of any audit, evaluation, or inspection, whichever is 
later.
     We are finalizing that APM Entities and eligible 
clinicians that submit information to us under Sec.  414.1440 must 
provide such information and supporting documentation to us upon 
request. We are codifying this policy at Sec.  414.1460(e)(3).
     We are finalizing that to the extent permitted by federal 
law, we will maintain confidentiality of the information that an APM 
Entity or eligible clinician submits to us for purposes of QP 
determinations under the All-Payer Combination Option.
     We are finalizing that eligible clinicians who are Partial 
QPs for the year under the All-Payer Combination Option would make the 
election whether to report to MIPS and then be subject to MIPS 
reporting requirements and payment adjustments.
7. Physician-Focused Payment Models (PFPMs)
a. Overview
    Section 1868(c) of the Act established an innovative process for 
individuals and stakeholder entities (stakeholders) to propose 
physician-focused payment models (PFPMs) to the Physician-Focused 
Payment Model Technical Advisory Committee (PTAC). The PTAC, 
established under section 1868(c)(1)(A) of the Act, is a federal 
advisory committee comprised of 11 members that provides advice to the 
Secretary. A copy of the PTAC's charter, established on January 5, 
2016, is available at https://aspe.hhs.gov/charter-physician-focused-payment-model-technical-advisory-committee.
    Section 1868(c)(2)(C) of the Act requires the PTAC to review 
stakeholders' proposed PFPMs, prepare comments and recommendations 
regarding whether such proposed PFPMs meet the PFPM criteria 
established by the Secretary, and submit those comments and 
recommendations to the Secretary. Section 1868(c)(2)(D) of the Act 
requires the Secretary to review the PTAC's comments and 
recommendations on proposed PFPMs and to post ``a detailed response'' 
to those comments and recommendations on the CMS Web site.
b. Definition of PFPM
Definition of PFPM
    In the CY 2017 Quality Payment Program final rule (81 FR 77555), we 
defined PFPM at Sec.  414.1465 as an Alternative Payment Model (APM) in 
which: Medicare is a payer; in which eligible clinicians that are 
eligible professionals as defined in section 1848(k)(3)(B) of the Act 
are participants and play a core role in implementing the APM's payment 
methodology; and which targets the quality and costs of services that 
eligible clinicians participating in the APM provide, order, or can 
significantly influence. We stated that a PFPM could include other 
payers in addition to Medicare, but that other payer arrangements and 
Other Payer Advanced APMs are not PFPMs. Therefore, PFPM proposals 
would need to include Medicare as a payer.
    In the CY 2018 Quality Payment Program proposed rule, we sought 
comment on whether to broaden the definition of PFPM to include payment 
arrangements that involve Medicaid or the Children's Health Insurance 
Program (CHIP) as a payer, even if Medicare is not included as a payer. 
A PFPM would then include Medicaid, CHIP, or Medicare (or some 
combination of these) as a payer. A PFPM might still include other 
payers in addition to Medicaid, CHIP, or Medicare; however, another 
payer arrangement or Other Payer Advanced APM that includes only 
private payers, including a Medicare Advantage (MA) plan, would not be 
a PFPM. As we indicated in the proposed rule, MA and other private 
plans paid to act as insurers on the Medicare program's behalf are 
considered to be private payers (82 FR 30208).
    We sought comment on whether broadening the definition of PFPM 
would be inclusive of potential PFPMs that could focus on areas not 
generally applicable to the Medicare population, such as pediatric 
issues or maternal health, and whether changing the definition of PFPM 
may engage more stakeholders in designing PFPMs that include more 
populations beyond Medicare FFS beneficiaries. We sought comment on how 
the PFPM criteria could be applied to these payment arrangements. We 
sought comment on whether including more issues and populations fits 
within the PTAC's charge and whether stakeholders are interested in the 
opportunity to allow the PTAC to apply its expertise to a broader range 
of proposals for PFPMs (82 FR 30208).
    The current definition of PFPM specifies that a PFPM is an APM. In 
the CY 2017 Quality Payment Program final rule (81 FR 77406), we noted 
that APM is defined under section 1833(z)(3)(C) of the Act as any of 
the following: (1) A model under section 1115A of the Act (other than a 
health care innovation award); (2) the Shared Savings Program under 
section 1899 of the Act; (3) a demonstration under section 1866C of the 
Act; or (4) a demonstration required by federal law. If a payment 
arrangement is a PFPM it must also be an APM. Under our current 
regulation, a model that does not meet the definition of APM is not a 
PFPM. However, a payment arrangement with Medicaid or CHIP as the 
payer, but not Medicare, would not necessarily meet the definition of 
APM. Therefore, we sought comment on whether we should, in conjunction 
with potentially broadening the scope of PFPMs to include payment 
arrangements with

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Medicaid and CHIP, require that a PFPM be an APM or a payment 
arrangement operated under legal authority for Medicaid or CHIP payment 
arrangements (82 FR 30208).
    We also sought comment on whether states and stakeholders see value 
in having the definition of PFPM broadened to include payment 
arrangements with Medicaid or CHIP but not Medicare as a payer, and 
whether they see value in having proposals for PFPMs with Medicaid or 
CHIP but not Medicare as a payer go through the PTAC's review process 
(82 FR 30209).
    The following is a summary of the public comments received on the 
areas where we sought comment related to the definition of PFPM and our 
responses:
    Comment: Many commenters were in favor of changing the definition 
of PFPM to include payment arrangements with Medicaid or CHIP, even if 
Medicare is not a payer. A few commenters suggested that the definition 
of PFPM be broadened to include Medicaid and CHIP and a combination of 
public and private payers, noting how coordination among such payers is 
critical for aligning incentives across payers and populations. Some 
commenters suggested that if the PFPM definition is changed to include 
payment arrangements with Medicaid or CHIP, then the PTAC should 
prioritize proposals that include Medicare. A few commenters were in 
favor of broadening the definition of PFPM to include Medicaid and CHIP 
payment arrangements under legal authorities other than those included 
in the definition of APM.
    Response: We thank commenters for their feedback. We did not 
propose changes to the PFPM definition in this rulemaking and are not 
making such changes at this time, but we will carefully consider all 
comments for future rulemaking.
    Comment: One commenter was concerned that broadening the definition 
of PFPM to include Medicaid and CHIP as payers (with or without 
Medicare as a payer) goes beyond statutory intent of the PTAC.
    Response: While we did not propose changes to the definition of 
PFPM in this rulemaking, we do not believe the statutory language 
limits the scope of proposals under the PTAC review process exclusively 
to those in which Medicare is a payer. We also note the Secretary has 
authority to update the criteria for PFPMs under section 
1868(c)(2)(A)(iii) of the Act.
    Comment: Some commenters recommended CMS broaden the definition of 
PFPM to include payment arrangements with MA or other private payers, 
but not Medicare, as a payer.
    Response: We thank commenters for their feedback. We appreciate the 
role that private payment arrangements could have in PFPMs. The current 
definition of PFPM requires that Medicare be a payer, but includes 
PFPMs that also include additional payers, such as MA or other private 
payers. However, we do not believe proposed PFPMs with only private 
payers are within the scope of models where the Secretary can 
effectuate or contribute to an outcome.
    Comment: One commenter requested that if the PFPM definition is 
expanded, Medicaid Managed Care and MA plan proposals should not seek 
review and approval by the PTAC and should be able to self-certify that 
their programs meet the criteria.
    Response: The PTAC's charge is to review submitted proposals for 
PFPMs and provide comments and recommendations to the Secretary as to 
whether such proposals meet the PFPM criteria established by the 
Secretary. The Secretary is required to review and post on the CMS Web 
site a detailed response to the PTAC's comments and recommendations.
    Comment: Many commenters emphasized the importance of including 
clinicians other than physicians in PFPMs. Many commenters suggested 
the PTAC consider payment models for ancillary services, such as long-
term care, durable medical equipment, and laboratories.
    Response: The definition of PFPM allows for proposals in which 
eligible clinicians who are eligible professionals as defined in 
section 1848(k)(3)(B) of the Act are participants and play a core role 
in implementing the APM's payment methodology. Under section 
1848(k)(3)(B) of the Act, eligible professionals are defined as: 
Physicians; practitioners described in section 1842(b)(18)(C) of the 
Act, such as nurse practitioners and physician assistants; physical or 
occupational therapists or qualified speech-language pathologists, and 
qualified audiologists.
    Final Action: We did not propose changes and we are not making 
changes at this time to the current definition of PFPM, which is an APM 
in which Medicare FFS is a payer, and thus does not include an APM in 
which Medicaid or CHIP is the only payer. Compared to APMs in which 
Medicare FFS is a payer, the PTAC's assessment of proposed PFPMs with 
only Medicaid or CHIP as a payer would be highly dependent on the role 
of states in the proposed PFPM. Given the uncertainties this could 
create during the PTAC's review, we believe it would be premature to 
expand the definition of PFPM at this point. Rather, we believe the 
PTAC can have the greatest impact by focusing on those proposed models 
where the Secretary has the greatest authority to directly advance or 
contribute to the implementation of the proposed model--that is, those 
that include Medicare FFS as a payer. However, we may seek further 
comment or propose a change of this nature in subsequent rulemaking.
(2) Relationship Between PFPMs and Advanced APMs
    In the CY 2018 Quality Payment Program proposed rule, we noted that 
section 1868(c) of the Act does not require PFPMs to meet the criteria 
to be an Advanced APM, and we did not define PFPMs solely as Advanced 
APMs. Stakeholders may therefore propose as PFPMs either Advanced APMs 
or Medical Home Models, or other APMs. We also noted that if we were to 
broaden the definition to include payment arrangements with Medicaid or 
CHIP but not Medicare as a payer, stakeholders could propose as PFPMs 
Medicaid APMs, Medicaid Medical Home Models, or other payer 
arrangements involving Medicaid or CHIP as a payer.
    Comment: Some commenters questioned whether the PFPM proposals that 
have been submitted to the PTAC will be Advanced APMs. Some commenters 
recommended alternative pathways for PFPMs to be considered Advanced 
APMs. A few commenters requested that PFPM proposals recommended by the 
PTAC and tested by CMS automatically be Advanced APMs or MIPS APMs, 
even if they do not meet criteria associated with those types of APMs.
    Response: We appreciate that there is continued interest in the 
opportunities available for eligible clinicians to participate in 
Advanced APMs and MIPS APMs. We did not propose changes to the 
definition of PFPM in this rulemaking. As stated above, to be a PFPM, a 
model must meet the definition of APM under section 1833(z)(3)(C) of 
the Act. If a PFPM is recommended by the PTAC and tested by CMS, and if 
it meets the criteria for an Advanced APM under section 1833(z)(3)(D) 
of the Act and as finalized in Sec.  414.1415 of our regulations, it 
will be an Advanced APM. We do not believe there is a reason that 
PFPMs, as a type of APM, should not be subject to the same criteria as 
other APMs in order to be considered Advanced APMs. To ensure 
consistency with our ability to

[[Page 53893]]

determine when a PFPM meets the criteria for an Advanced APM, we intend 
to keep PFPMs defined as a type of APM. Similarly, classification as a 
MIPS APM requires that a model meets the criteria finalized in Sec.  
414.1370 of our regulations. The financial risk and other 
characteristics of a PFPM may help inform a recommendation by the PTAC, 
but a PTAC recommendation does not necessarily mean that the PFPM meets 
the criteria to be an Advanced APM or a MIPS APM. These determinations 
will be made if the proposed PFPM is tested by CMS.
    Final Action: We did not propose changes and we are not making 
changes at this time to the definition of PFPM. Stakeholders may 
propose PFPMs and if selected for testing, CMS will determine the 
appropriate APM status of PFPMs.
c. PTAC Review Process of PFPM Proposals With Medicaid or CHIP as a 
Payer
    In the CY 2017 Quality Payment Program final rule (81 FR 77491-92), 
we described the roles of the Secretary, the PTAC, and CMS as they 
relate to PFPMs and the PTAC's review process. We provided additional 
information about the level of consideration the Secretary will give 
proposed PFPMs recommended by the PTAC and why we decline committing to 
specific timeframes for testing PFPMs. Although we believe that 
proposed PFPMs that meet all of the PFPM criteria and are recommended 
by the PTAC may need less time to go through the development process, 
we cannot guarantee that the development process would be shortened or 
estimate by how much it would be shortened. In the CY 2018 Quality 
Payment Program proposed rule, we reiterated these points and also 
included a discussion of how these principles might be applied were we 
to expand the definition of PFPM to include payment arrangements with 
Medicaid or CHIP, but not Medicare, as a payer (82 FR 30209).
    The following is a summary of the public comments received on the 
areas where we sought comment related to the PTAC review process of 
PFPM proposals with Medicaid or CHIP as a payer and our responses:
    Comment: One commenter was in favor of us retaining the authority 
to determine whether to test proposed models recommended by the PTAC 
but suggested that we should be transparent in why CMS will or will not 
test a PFPM proposal and allow interested parties to seek more 
information about the decision-making process.
    Response: We agree with the commenter. The Secretary's response to 
the PTAC's comments and recommendations regarding proposed PFPMs will 
be made available on the CMS Web site, after the Secretary's review of 
the PTAC's comments and recommendations, at https://innovation.cms.gov/initiatives/pfpms/.
    Comment: One commenter requested that we encourage the PTAC to 
establish a timeline for PFPM proposal review.
    Response: The PTAC has described a proposal review process and 
timeline in a document entitled ``Proposal Submission Instructions'', 
available at https://aspe.hhs.gov/system/files/pdf/255906/ProposalSubmissionInstructions.pdf.
    Comment: A few commenters requested that we test all PFPM proposals 
recommended by the PTAC, that there be a rebuttable presumption that 
any PFPM proposal recommended will be tested, or that we prioritize 
testing PFPM proposals recommended by the PTAC.
    Response: We intend to continue to give serious consideration to 
proposed PFPMs recommended by the PTAC. However, section 1868(c) of the 
Act does not require CMS to test proposals that are recommended by the 
PTAC, and, as we discussed in the CY 2017 Quality Payment Program final 
rule, we are unable to commit to testing every PFPM proposal 
recommended by the PTAC given that we are unable to predict the volume, 
quality, or appropriateness of the proposed PFPMs on which the PTAC 
will make comments and recommendations (81 FR 77491).
    Comment: Many commenters requested a deadline for the Secretary's 
response to comments and recommendations from the PTAC, such as 60 or 
90 days. Some commenters requested more information about the process 
for testing proposed PFPMs recommended by the PTAC, including requests 
that we make public a specific process. A few commenters requested that 
we expedite approval of and begin testing PFPM proposals recommended by 
the PTAC within an established timeframe. One commenter requested the 
public comment timeframe for PFPM proposals be extended.
    Response: As discussed in the CY 2017 Quality Payment Program final 
rule, setting a deadline for the Secretary's response would be 
difficult given that there may be variation in the number and frequency 
of proposals (81 FR 77492). The Secretary would need varying lengths of 
time to review, comment on, and respond to PFPM proposals depending on 
the volume and nature of each proposal. With respect to processes for 
testing proposed PFPMs, the processes for testing proposed PFPMs depend 
on the nature of the PFPM's design, among other factors. An attempt to 
impose a deadline on them would diminish our ability to tailor review 
and development to the needs of the PFPM proposal. However, we are 
mindful of stakeholders' interest in a timely process and are committed 
to reviewing (and where appropriate, implementing) PFPM proposals, with 
or without Medicaid or CHIP as a payer, as quickly as possible (81 FR 
77492). We did not seek comments on the public comment timeframe for 
PFPM proposals, but the PTAC determines the process for reviewing 
proposed PFPMs. Currently, the PTAC generally allows three weeks for 
public comments.
    Comment: Some commenters requested specific representation of 
certain types of clinicians or experts on the PTAC.
    Response: While we appreciate the comments, they are outside of the 
scope of CMS authority in that section 1868(c)(1)(B)(i) of the Act 
authorizes the Comptroller General of the United States (GAO) to 
appoint members of the PTAC, not CMS.
    Final Action: We did not propose and are not making any additions 
or changes to the process or timeline for review of proposed PFPMs. In 
order to preserve flexibility in considering diverse proposals of 
varying scope and features, we continue to believe it would not be 
appropriate to establish through rulemaking a single process or 
timeline for the PTAC's review or for implementation of proposed models 
recommended by the PTAC. Section 1868(c)(2)(D) of the Act requires the 
Secretary to review the PTAC's comments and recommendations on proposed 
PFPMs and to post a ``detailed response'' to those comments and 
recommendations on the CMS Web site. Therefore, the Secretary has a 
responsibility to review comments and recommendations from the PTAC on 
PFPM proposals and a responsibility to respond. However, we appreciate 
that commenters seek additional information from us on our process. We 
are mindful of stakeholders' interest in a timely process and are 
committed to reviewing (and where appropriate, implementing) PFPM 
proposals as quickly as possible.
d. PFPM Criteria
    In the CY 2017 Quality Payment Program final rule (81 FR 77555), we 
finalized the Secretary's criteria for PFPMs as required by section 
1868(c)(2)(A)(i) of the Act (PFPM criteria). The PFPM criteria are for 
the PTAC's use in discharging its duties under section 1868(c)(2)(C) of 
the Act to

[[Page 53894]]

make comments and recommendations to the Secretary on proposed PFPMs.
    In the CY 2018 Quality Payment Program proposed rule, we sought 
comment on the PFPM criteria, including, but not limited to, whether 
the criteria are appropriate for evaluating PFPM proposals and are 
clearly articulated. In addition, we sought comment on stakeholders' 
needs in developing PFPM proposals that meet the Secretary's criteria. 
In particular, we want to know whether stakeholders believe there is 
sufficient guidance available on what constitutes a PFPM, the 
relationship between PFPMs, APMs, and Advanced APMs; and on how to 
access data, or how to gather supporting evidence for a PFPM proposal 
(82 FR 30209).
    The following is a summary of the public comments received on the 
areas where we sought comment related to the PFPM criteria and our 
responses:
    Comment: One commenter requested that we provide actionable 
information for clinicians to develop and propose meaningful PFPMs, 
including publication of relevant, objective benchmarks that the PTAC 
will use to recommend proposed models and for us to test proposed 
PFPMs.
    Response: To help inform the development of APMs, PFPMs, and 
Advanced APMs, including design, evaluation, and APM elements, CMS 
developed an APM Design Toolkit, available at https://qpp.cms.gov/docs/QPP_APM_Design_Toolkit.pdf. Additionally, the PTAC provides resources 
to guide proposal development and submission, and they are available at 
https://aspe.hhs.gov/resources-public-comment-physician-focused-payment-model-technical-advisory-committee. The PFPM criteria were 
designed to promote payment incentives for higher-value care, including 
paying for value over volume and providing resources and flexibility 
necessary for practitioners to deliver high-quality health care. The 
PTAC uses the PFPM criteria established by the Secretary to frame its 
comments and recommendations. It is the PTAC's responsibility to assess 
if and how each proposal meets every criterion.
    Comment: One commenter requested that in evaluating PFPM proposals, 
the PTAC focus on and prioritize results and outcomes, as opposed to 
the methods and means.
    Response: When considering whether and how to test PFPMs, along 
with the implications of distinct model designs, there are a number of 
operational and administrative factors we must consider, including 
those that the Innovation Center currently uses to determine which 
models to test, as described in the document available at https://innovation.cms.gov/files/x/rfi-websitepreamble.pdf.
    Comment: A few commenters recommended additional criteria for 
PFPMs, including a patient-centered approach and having the model place 
the physician as the hub of care delivery and coordination.
    Response: While we are not proposing changes to the criteria, we 
believe these considerations fall within the existing criteria for PFPM 
proposals, specifically the Integration and Care Coordination and 
Patient Choice criteria.
    Comment: One commenter requested that the criteria be revised to 
elevate the value and importance of specialists in PFPMs. Another 
commenter suggested proposal submitters be required to consult 
participating and affected specialties prior to submission to the PTAC. 
One commenter suggested that we consider expanding the PFPM Payment 
Methodology criterion to include consideration of whether episodes of 
care defined in the proposed PFPM have undergone stakeholder vetting. 
One commenter recommended that the PTAC request submission of a list of 
clinical experts either with the PFPM letter of intent or with the PFPM 
completed application.
    Response: While we appreciate the comments, they are outside of the 
scope of CMS rulemaking in that the PTAC establishes guidance for PFPM 
proposal submissions, not CMS. It is the PTAC's responsibility to 
assess if and how the design of a proposed PFPM meets the PFPM 
criteria. We believe considerations related to an intervention's 
relationship to specialty care fall within the existing Scope, 
Flexibility, and Integration and Care Coordination PFPM criteria. We 
note that section 1868(c) of the Act does not require as part of the 
definition of a PFPM or within the PFPM criteria that a particular 
specialty or category of clinician be addressed.
    Comment: One commenter suggested that we amend the existing 
Flexibility criterion from ``provide the flexibility needed for 
practitioners to deliver high-quality health care'' to ``provide the 
flexibility needed for practitioners to deliver high-quality health 
care, including adapting to account for new technologies.''
    Response: While we are not proposing changes to the Flexibility 
criterion, we do recognize practitioners have varying capacities to 
adapt to and adopt new technologies.
    Comment: One commenter requested that the PTAC welcome all ideas 
and proposals regardless of the existence of other payment models 
within the CMS portfolio.
    Response: We appreciate the comment. The PTAC reviews all PFPM 
proposals that are complete based on the requirements outlined in 
``PTAC's Physician-Focused Payment Models: PTAC Proposal Submission 
Instructions'', available at https://aspe.hhs.gov/system/files/pdf/255906/ProposalSubmissionInstructions.pdf. However, all complete 
proposals will be subject to the PTAC's analysis of the Scope criterion 
which reflects a desire to maximize the diversity of CMS' APM portfolio 
by offering opportunities to propose PFPMs in areas not addressed under 
existing APMs, including Advanced APMs.
    Comment: One commenter recommended that the Secretary's Payment 
Methodology criterion require a neutral party determine and disseminate 
payments to participants to avoid financial conflict of interest, 
particularly in proposals involving multiple specialties.
    Response: The PTAC assesses each PFPM proposal against the PFPM 
criteria. If a PFPM proposal is recommended for implementation, and CMS 
decides to test the proposed PFPM, then CMS would work to address any 
concerns related to the payment methodology, including conflicts of 
interest, and if necessary make changes to the PFPM design prior to 
implementation.
    Comment: One commenter recommended that we assign high priority to 
the Patient Safety criterion to ensure access to necessary services is 
not compromised for the sake of establishing new models.
    Response: The PTAC reviews each PFPM proposal against the PFPM 
criteria, and has designated three of those criteria as High Priority: 
Scope; Quality and Cost; and Payment Methodology. The Secretary reviews 
the PTAC's comments related to all PFPM criteria, including Patient 
Safety. If patient access is a concern within a proposed PFPM, then we 
would expect the PTAC's comments on the Patient Safety and Patient 
Choice criteria to address access issues. The PTAC's Physician-Focused 
Payment Models: PTAC Proposal Submission Instructions direct 
individuals and organizations submitting PFPM proposals to include 
certain supporting information specific to each of the PFPM criteria, 
which the PTAC will use to evaluate the extent to which submitted PFPM 
proposals meet the PFPM criteria. For the Patient Safety criterion, the 
PTAC recommends that proposals explain how patients would be protected 
from potential disruption

[[Page 53895]]

in health care delivery brought about by the changes in payment 
methodology and provider incentives. The Patient Choice criterion 
encourages greater attention to the health of the population served 
while also supporting the unique needs and preferences of individual 
patients. We believe these criteria and supplemental information allow 
the PTAC to analyze potential adverse impact to access to necessary 
services.
    Comment: One commenter urged PTAC to guard against proposals that 
could create a chilling effect against innovation in techniques and 
treatment modalities.
    Response: We believe the PFPM criteria, the PTAC's analysis of PFPM 
proposals using PFPM criteria, and the Secretary's response to the 
PTAC's recommendations are all intended to safeguard against any 
chilling effects against innovation in techniques and treatment 
modalities.
    Comment: Many commenters requested that the Department provide 
``technical assistance'' to stakeholders developing and submitting PFPM 
proposals. One commenter recommended that CMS develop clear guidance 
documents, tools, and efforts separate from the release of rulemaking 
for the Quality Payment Program to better stimulate development of 
robust proposals. Many commenters requested that CMS make as much data 
available as possible to assist stakeholders in developing PFPMs.
    Response: We are committed to continuing to explore and consider 
ways to be responsive to stakeholders in developing PFPM proposals. To 
that end, we have developed a resource to help inform the development 
of APMs, PFPMs, and Advanced APMs. This resource, the APM Design 
Toolkit, is available at https://qpp.cms.gov/docs/QPP_APM_Design_Toolkit.pdf. Additionally, the PTAC provides resources 
to guide proposal development and submission, and they are available at 
https://aspe.hhs.gov/resources-public-comment-physician-focused-payment-model-technical-advisory-committee. We have made available a 
Model Design Factors document, available at https://innovation.cms.gov/
files/x/rfi-Websitepreamble.pdf, describing the operational and 
administrative factors that the Innovation Center currently uses to 
determine which models to test. These factors are similarly important 
to consider for PFPMs. We hope these resources are helpful. CMS is 
currently focused on developing additional APMs, including PFPMs. We 
encourage stakeholders to continue to submit proposals to the PTAC.
    Comment: Some commenters specifically requested that CMS also 
interpret or assist stakeholders in analyzing and interpreting data.
    Response: We recognize the value of data analysis in developing 
PFPM proposals. We will continue to consider ways we may be able to 
support data needs related to PFPM proposal development.
    Comment: One commenter suggested that for proposals the PTAC 
recommends for testing, CMS should accept a qualitative description of 
the payment with quantitative data in lieu of a payment methodology 
with payment amount(s).
    Response: We recognize that proposal submitters may not have the 
resources required to fully design a payment methodology similar to 
that of models currently being tested. For proposed PFPMs that the PTAC 
recommends and CMS selects for testing, CMS will undertake a robust 
analysis of the proposed payment methodology as appropriate prior to 
testing.
    Final Action: We did not propose and are not making changes to the 
definition of PFPM at this time. We similarly did not propose and are 
not making changes to the PFPM criteria at this time. We will consider 
the feedback on the PFPM definition and PFPM criteria received from 
commenters as we continue to assess including APMs with Medicaid and 
CHIP as payers in the PFPM definition and explore ways to provide 
additional guidance and information related to PFPMs. We will also 
consider comments on whether there is sufficient guidance on what 
constitutes a PFPM; the relationship between PFPMs, APMs, and Advanced 
APMs; and on how to access data, or how to gather supporting evidence 
for a PFPM proposal. We will continue to consider how to provide 
additional types of guidance in addition to the resources already 
available to those developing PFPM proposals.
e. Summary
    In this final rule with comment period, we are not proposing or 
making changes to the existing definition of PFPM or the PFPM criteria. 
We will consider the comments received on the adequacy of guidance 
available on PFPM criteria and, within the scope of CMS authority, 
follow the guidance of the Secretary in the Secretary's responses to 
the PTAC comments and recommendations.

III. Quality Payment Program: Extreme and Uncontrollable Circumstance 
Policy for the Transition Year Interim Final Rule With Comment Period

A. Background

1. Significant Hardship and Extreme and Uncontrollable Circumstances in 
the MIPS Program
    This interim final rule with comment period is being issued in 
conjunction with the final rule with comment period and its provisions 
discussed in sections II.C.6.f.(7) and II.C.7.b.(3)(c) pertaining to 
the policies that apply to MIPS eligible clinicians who are subject to 
extreme and uncontrollable circumstances. As we discussed in section 
II.C.6.f.(7) of the final rule with comment period, we established a 
policy to assign a weight of zero percent to the advancing care 
information performance category in the final score for MIPS eligible 
clinicians who demonstrate a significant hardship through an 
application process, and we are relying on section 1848(o)(2)(D) of the 
Act as the authority for that policy. We recognized that one type of 
significant hardship a clinician might experience would be extreme and 
uncontrollable circumstances, such as a natural disaster in which an 
EHR or practice building are destroyed (81 FR 77241). This policy for 
the advancing care information performance category applies beginning 
with the transition year of MIPS (2017 performance period/2019 MIPS 
payment year) (81 FR 77240 through 77243). As we discussed in section 
II.C.6.f.(7) of the final rule with comment period, to be considered 
for reweighting of the advancing care information performance category 
in the final score for the transition year based on extreme and 
uncontrollable circumstances, a MIPS eligible clinician must submit an 
application by December 31, 2017. A MIPS eligible clinician who is 
eligible for reweighting but chooses to report (as an individual, 
group, or virtual group) for the advancing care information performance 
category will be scored on the performance category like all other MIPS 
eligible clinicians, and the performance category will be given the 
weighting prescribed by section 1848(q)(5)(E) of the Act regardless of 
their advancing care information performance category score.
    In addition, as we discussed in section II.C.7.b.(3)(c) of the 
final rule with comment period, we are establishing a similar policy 
for the quality, cost, and improvement activities performance 
categories beginning with the second year of MIPS

[[Page 53896]]

(2018 performance period/2020 MIPS payment year). For these performance 
categories, we define ``extreme and uncontrollable circumstances'' as 
rare (that is, highly unlikely to occur in a given year) events 
entirely outside the control of the clinician and of the facility in 
which the clinician practices that cause the MIPS eligible clinician to 
be unable to collect information that the clinician would submit for a 
performance category or to submit information that would be used to 
score a performance category for an extended period of time (for 
example, 3 months with respect to data collection for the quality 
performance category). We provided the example of a tornado or fire 
destroying the only facility where a clinician practices as a likely 
extreme and uncontrollable circumstance. We are establishing this 
policy under the authority of section 1848(q)(5)(F) of the Act and 
refer readers to section II.C.7.b.(3)(c) of the final rule with comment 
period for a discussion of how extreme and uncontrollable 
circumstances, such as natural disasters, could affect whether there 
are sufficient measures and activities applicable and available to MIPS 
eligible clinicians. Under the policy, MIPS eligible clinicians who are 
affected by extreme and uncontrollable circumstances may submit a 
request for reweighting of the quality, cost, and/or improvement 
activities performance categories for the second year of MIPS by the 
deadline of December 31, 2018. The policy does not apply to APM 
Entities under the APM scoring standard.
2. Extraordinary Circumstances Exceptions in Other CMS Quality Programs
    For many of our quality reporting and value-based purchasing 
programs for hospitals and other types of facilities, we have adopted 
extraordinary circumstances exceptions (ECE) policies. In the FY 2018 
IPPS/LTCH PPS final rule (82 FR 38410) and CY 2018 OPPS/ASC proposed 
rule (82 FR 33683), we worked to align common processes for our ECE 
policies across many of our quality programs including the Hospital IQR 
Program, Hospital OQR Program, IPFQR Program, ASCQR Program, and PCHQR 
Program, as well as the Hospital VBP Program, HAC Reduction Program, 
and the Hospital Readmissions Reduction Program. Using the Hospital IQR 
Program as an example, generally, CMS may grant an exception with 
respect to quality data reporting requirements in the event of 
extraordinary circumstances beyond the control of the hospital (42 CFR 
412.140(c)(2)). Specific requirements for submission of a request for 
an exception are available on QualityNet.org. As part of this ECE 
policy, CMS may grant an exception to one or more hospitals that have 
not requested an exception if: CMS determines that a systemic problem 
with CMS data collection systems directly affected the ability of the 
hospital to submit data; or if CMS determines that an extraordinary 
circumstance, such as an act of nature (for example, hurricane), has 
affected an entire region or locale (Sec.  412.140(c)(2) and 76 FR 
51651). We stated that if we make the determination to grant an ECE to 
hospitals in a region or locale, we would communicate this decision 
through routine communication channels (76 FR 51652 and 82 FR 38410).
3. Hurricanes Occurring in 2017
    The events of Hurricanes Harvey, Irma, and Maria impacted large 
regions of the United States in August and September of 2017. These 
events occurred over a period of several days and led to widespread 
destruction of infrastructure within impacted regions which impacted 
residents' ability to carry on normal functions in the months following 
the events. Hurricane Harvey made landfall in Texas as a category 4 
hurricane on August 25, 2017, and produced rainfall totals of 45 to 50 
inches (depending on county) over a 5-day period. The rainfall caused 
catastrophic drainage issues and made rivers rise greatly. After moving 
offshore, Harvey made a third landfall just west of Cameron, Louisiana 
on the morning of August 30th and brought more heavy rainfall to the 
Northern Gulf States.\21\ Hurricane Irma was a Category 5 hurricane 
with peak sustained winds of 185 miles per hour and gusts in the 200s. 
Hurricane Irma inflicted devastating damage on the northernmost Leeward 
Islands, and U.S./British Virgin Islands. The storm made landfall in 
Florida as a category 4 hurricane on September 10th producing wind 
gusts of 120 to 142 miles per hour. Tropical rains and gusty winds then 
arrived to a larger portion of the Southeastern United States.\22\ 
Hurricane Maria brought maximum sustained winds of 145 miles per hour 
to 230 miles per hour.\23\ Hurricane Maria hit Puerto Rico on September 
20th as a category 4 hurricane causing widespread power outages and 
damage to infrastructure throughout the territory.\24\ \25\ We have 
recently granted ECEs from reporting requirements for CMS programs 
(including value-based purchasing programs for skilled nursing 
facilities, hospices, and inpatient rehabilitation facilities) as a 
result of Hurricanes Harvey, Irma, and Maria.\26\ Following these 
events, we released communication indicating the areas impacted, as 
well as the scope and duration of the exceptions provided. For example, 
CMS granted an ECE for certain requirements under the Hospital IQR 
Program for subsection (d) hospitals impacted by Hurricane Irma, 
including the HCAHPS Survey and chart-abstracted measures for 
discharges occurring in the 2nd and 3rd quarters of 2017. However, for 
the Hospital Value-Based Purchasing (VBP) Program, Hospital-Acquired 
Condition (HAC) Reduction Program, and Hospital Readmissions Reduction 
Program, we requested that providers or facilities directly impacted by 
hurricane or resulting flood damage submit individual ECE Requests. 
\27\ We refer readers to the posting at https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Memo-Requirements-Facilities-Irma.pdf for more information on the ECE for Hurricane Irma.
---------------------------------------------------------------------------

    \21\ National Weather Service. Hurricane Harvey Info. Available 
at http://www.weather.gov/hgx/hurricaneharvey.
    \22\ National Weather Service. Impacts from Irma- September 
2017. Available at http://www.weather.gov/bmx/event_irma2017.
    \23\ National Hurricane Center. Hurricane Maria Update 
Statement. http://www.nhc.noaa.gov/text/MIATCUAT5.shtml.
    \24\ More information can be found at https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Memo-Requirements-Facilities-Maria.pdf.
    \25\ National Hurricane Center. Hurricane Maria Discussion 
Number 18. Available at http://www.nhc.noaa.gov/archive/2017/al15/al152017.discus.018.shtml.
    \26\ CMS communication regarding these ECEs can be found at the 
following links:
    Irma: https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Memo-Requirements-Facilities-Irma.pdf.
    Harvey:  https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/2017-121-IP-Quality-Program-Exemptions-for-FEMA-Texas-Louisiana-Providerpdf.pdf.
    Maria: https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Memo-Requirements-Facilities-Maria.pdf.
    \27\ See https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Memo-Requirements-Facilities-Irma.pdf.
---------------------------------------------------------------------------

B. Changes to the Extreme and Uncontrollable Circumstances Policies for 
the MIPS Transition Year

1. Automatic Extreme and Uncontrollable Circumstance Policy for the 
2017 MIPS Performance Period
    Due to Hurricanes Harvey, Irma, and Maria, which occurred during 
the 2017 MIPS performance period, we believe that changes to our 
policies for extreme and uncontrollable circumstances are

[[Page 53897]]

warranted for the transition year for individual MIPS eligible 
clinicians. We do not currently have an extreme and uncontrollable 
circumstance policy for the transition year for the quality, cost, and 
improvement activities performance categories. As discussed above, the 
final policy we adopted in section II.C.7.b.(3)(c) of the final rule 
with comment period applies beginning with the 2018 performance period/
2020 MIPS payment year. In addition, our existing extreme and 
uncontrollable circumstance policy for the advancing care information 
performance category requires MIPS eligible clinicians to submit a 
request for reweighting to us by December 31, 2017.
    Given the broad impact of these three hurricanes, in this interim 
final rule with comment period, we are establishing a policy for the 
2017 MIPS performance period under which we would apply the extreme and 
uncontrollable circumstance policies for the MIPS performance 
categories as described in sections II.C.6.f.(7) and II.C.7.b.(3)(c) of 
the final rule with comment period without requiring a MIPS eligible 
clinician to submit an application when we determine a triggering 
event, as described in section III.B.1.a. of this interim final rule 
with comment period, has occurred and the clinician is in an affected 
area. We refer to this policy as the ``automatic extreme and 
uncontrollable circumstance policy.'' We believe the automatic extreme 
and uncontrollable circumstance policy will reduce burden for 
clinicians who have been affected by these catastrophes and will also 
align with existing Medicare policies in other programs such as the 
Hospital IQR Program. Further, we believe it is necessary to adopt the 
automatic extreme and uncontrollable circumstance policy in an interim 
final rule with comment period due to the urgency of providing relief 
for MIPS eligible clinicians impacted by the recent hurricane events 
during the 2017 MIPS performance period. In particular, we are 
concerned about individual MIPS eligible clinicians receiving a 
negative MIPS payment adjustment for failure to submit information on 
the MIPS measures and activities when events outside of their control, 
such as the hurricanes, would likely constitute a significant hardship 
for clinicians and affect whether sufficient measures and activities 
are applicable and available to them. As discussed in section III.B.1. 
of this interim final rule with comment period, although this policy 
includes individual MIPS eligible clinicians who practice in impacted 
areas and are part of a group practice, the policy does not apply to 
groups for the transition year, although we may address its application 
to groups in future rulemaking. We believe there is less urgency to 
establish a policy for groups given the low performance threshold 
(three points) for the transition year, and the fact that groups are 
only scored as groups if they submit information to MIPS as a group. 
For these reasons, we believe virtually all groups (including those in 
the impacted areas) would not receive final scores below the 
performance threshold, and thus the MIPS eligible clinicians in those 
groups would not be subject to a negative payment adjustment.
    We invite public comment on our automatic extreme and 
uncontrollable circumstance policy for individual MIPS eligible 
clinicians for the 2017 MIPS performance period.
a. Triggering Events for the Automatic Extreme and Uncontrollable 
Circumstance Policy
    Under the automatic extreme and uncontrollable circumstance policy, 
we will have discretion not to require MIPS eligible clinicians to 
submit an application for reweighting the performance categories in 
cases where an extreme and uncontrollable circumstance, such as an act 
of nature (for example, hurricane), affects an entire region or locale. 
Generally, we anticipate the types of events that could trigger this 
policy would be events designated a Federal Emergency Management Agency 
(FEMA) major disasters or a public health emergency declared by the 
Secretary, although we will review each situation on a case-by-case 
basis. We also generally intend to align the automatic extreme and 
uncontrollable circumstance policy with the ECE policies for other 
Medicare programs such that events that trigger ECE policies would also 
trigger the automatic extreme and uncontrollable circumstance policy.
    We believe that Hurricanes Harvey, Irma, and Maria are such 
triggering events and have provided details about the affected regions 
in section III.B.1.d. of this interim final rule with comment period. 
Should additional extreme and uncontrollable circumstances arise for 
the 2017 MIPS performance period that trigger the automatic extreme and 
uncontrollable circumstance policy, then we would communicate that 
information through routine communication channels, including but not 
limited to issuing memos, emails, and notices on the QPP Web site, 
qpp.cms.gov.
    We invite comments on applying the automatic extreme and 
uncontrollable circumstance policy based on triggering events that 
affect an entire region or locale, on a case-by-case basis.
b. Scoring Considerations for Performance Categories Under the 
Automatic Extreme and Uncontrollable Circumstance Policy
    If we determine that an event should trigger the automatic extreme 
and uncontrollable circumstance policy, then we will assume that MIPS 
eligible clinicians in the affected areas do not have sufficient 
measures and activities available and applicable to them for the 
quality and improvement activities performance categories. Similarly, 
we will assume that MIPS eligible clinicians in the affected areas are 
experiencing a significant hardship as a result of the triggering event 
and would qualify for a significant hardship exception for the 
advancing care information performance category. We will not require 
MIPS eligible clinicians in the affected areas to submit an application 
to CMS (as described in sections II.C.6.f.(7) and II.C.7.b.(3)(c) of 
the final rule with comment period) requesting that the performance 
categories be reweighted. We believe requiring an application could be 
overly burdensome to these MIPS eligible clinicians who have been 
affected by extreme events, such as hurricanes and other natural 
disasters, and who may have been displaced from their homes or practice 
locations as a result of such events. Because the cost performance 
category has a zero percent weight for the 2017 MIPS performance 
period, we are not including the cost performance category in the 
automatic extreme and uncontrollable circumstances policy for the 
transition year.
    For MIPS eligible clinicians who practice in the affected areas, if 
they do not submit data for the quality, advancing care information, 
and/or improvement activities performance categories, then each 
category for which they do not submit data will not be scored and will 
be assigned a weight of zero percent in the final score. Because we 
believe the final score should be a composite score, we adopted a 
policy in section II.C.7.b.(2) of the final rule with comment period 
that a MIPS eligible clinician with fewer than two performance category 
scores will receive a final score equal to the performance threshold, 
and we would apply this policy for the transition year as well as 2018 
and subsequent years.
    It is possible that some MIPS eligible clinicians in the affected 
areas may not be significantly impacted by the extreme and 
uncontrollable circumstance. These clinicians might not experience a

[[Page 53898]]

significant hardship as a result of the extreme and uncontrollable 
circumstance, and thus, would not need an exception for the advancing 
care information performance category, and they might have sufficient 
MIPS measures and activities available and applicable to them for the 
quality or improvement activities performance categories such that they 
would be able to report on those categories. We believe it is important 
to ensure these clinicians who are not significantly affected by the 
extreme and uncontrollable circumstance can participate in MIPS. 
Therefore, under the policy we are adopting, if a MIPS eligible 
clinician in an affected area submits data for any of the MIPS 
performance categories by the applicable submission deadline for the 
2017 performance period, they will be scored on each performance 
category for which they submit data, and the performance category will 
not be reweighted to zero percent in the final score.
    For the 2017 MIPS performance period, it is possible we may receive 
data from MIPS eligible clinicians in affected areas that does not 
represent the entire performance period. In those cases, we will score 
the submitted data, even if does not represent the entire performance 
period. For example, for the claims submission mechanism for the 
quality performance category, measures are submitted by adding quality 
data codes to a claim. It is possible that a MIPS eligible clinician in 
an affected area could have submitted some data prior to the triggering 
event for the automatic extreme and uncontrollable circumstance policy. 
However, due to the policy we adopted in section II.C.7.b.(2) of the 
final rule with comment period that a MIPS eligible clinician with 
fewer than two performance category scores will receive a final score 
equal to the performance threshold, the clinician would also have to 
submit data for the improvement activities or the advancing care 
information performance categories in order to receive a final score 
higher than the performance threshold.
    For measures which we derive from administrative claims data, such 
as the all-cause hospital readmission measure and the cost measures, 
clinicians do not submit data other than claims. However, for the 2017 
MIPS performance period/2019 MIPS payment period, cost measures are not 
used to determine the MIPS final score and the only administrative 
claims quality measure used to determine the MIPS final score is the 
readmission measure, which is only applied to groups (which are 
excluded from our automatic extreme and uncontrollable circumstance 
policy); therefore, administrative claims measures are not included in 
our automatic extreme and uncontrollable circumstance policy for this 
interim final rule with comment period.
    We invite public comments on these policies related to scoring the 
performance categories.
d. Identifying MIPS Eligible Clinicians in Affected Areas
    We will determine if an individual MIPS eligible clinician is in an 
impacted area based on the practice location address listed in the 
Provider Enrollment, Chain and Ownership System (PECOS). As discussed 
above, the individual MIPS eligible clinician will receive a final 
score equal to the performance threshold for the 2017 MIPS performance 
period if they do not submit any data or submit data on only one 
performance category by the applicable submission deadline for the 2017 
performance period. If the individual MIPS eligible clinician submits 
data on 2 or more performance categories, then the clinician will be 
scored on their data submissions under the policies that apply to all 
other MIPS eligible clinicians who are not in affected areas.
    As discussed above, groups are not included in the automatic 
extreme and uncontrollable circumstance policy in this interim final 
rule with comment period. We would consider expanding this policy to 
include groups in future years, but we believe there are some policy 
questions that need to be addressed through rulemaking first. For 
example:
     How should we determine whether a group, which may have 
multiple practice sites, should qualify for the automatic extreme and 
uncontrollable circumstance policy?
     Should it be based on whether a certain percentage of the 
clinicians in the group are located in an affected area?
    As we explained above, we believe it is less urgent to establish a 
policy for groups for the transition year. If an individual MIPS 
eligible clinician's practice location address as listed in PECOS is in 
an affected area, and the clinician is part of a group practice that 
reports as a group for MIPS for the 2017 performance period and 
receives a final score below the performance threshold (as explained 
above, we believe this will be unlikely given the low performance 
threshold of 3 points), that clinician still will receive a final score 
equal to the performance threshold under our policy. We seek comment on 
our policy to determine which MIPS eligible clinicians are in affected 
areas based on practice location addresses listed in PECOS, and how we 
should apply the automatic extreme and uncontrollable circumstance 
policies for groups and virtual groups in future years.
e. Regions Impacted by Harvey, Irma, and Maria
    We believe the recent Hurricanes Harvey, Irma, and Maria are 
triggering events for the automatic extreme and uncontrollable 
circumstance policy we are adopting in this interim final rule with 
comment period. The regions impacted by these events are defined as a 
major disaster county, municipal (municipio in Spanish), or county-
equivalent by the Federal Emergency Management Agency (FEMA) and are:
     All 67 counties in Florida.
     All 159 counties in Georgia.
     The following parishes of Louisiana: Acadia; Allen; 
Assumption; Beauregard; Calcasieu; Cameron; De Soto; Iberia; Jefferson 
Davis; Lafayette; Lafourche; Natchitoches; Plaquemines; Rapides; Red 
River; Sabine; St. Charles; St. Mary; Vermilion; and Vernon.
     All 78 municipios in Puerto Rico.
     The following counties of South Carolina: Allendale; 
Anderson; Bamberg; Barnwell; Beaufort; Berkeley; Charleston; Colleton; 
Dorchester; Edgefield; Georgetown; Hampton; Jasper; McCormick; Oconee; 
and Pickens.
     The following counties in Texas: Aransas; Austin; Bastrop; 
Bee; Bexar; Brazoria; Burleson; Caldwell; Calhoun; Chambers; Colorado; 
Comal; Dallas; Dewitt; Fayette; Fort Bend; Galveston; Goliad; Gonzales; 
Grimes; Guadalupe; Hardin; Harris; Jackson; Jasper; Jefferson; Jim 
Wells; Karnes; Kleberg; Lavaca; Lee; Liberty; Madison; Matagorda; 
Milam; Montgomery; Newton; Nueces; Orange; Polk; Refugio; Sabine; San 
Augustine; San Jacinto; San Patricio; Tarrant; Travis; Tyler; Victoria; 
Walker; Waller; Washington; and Wharton.
     All of the U.S. Virgin Islands.
    These lists may continue to be updated. The most current list of 
impacted areas can be found at https://www.cms.gov/About-CMS/Agency-Information/Emergency/index.html?redirect=/emergency.

C. Changes to the Final Score and Policies for Redistributing the 
Performance Category Weights for the Transition Year

    As discussed above, we adopted a policy in section II.C.7.b.(2) of 
the final rule with comment period that a MIPS eligible clinician with 
fewer than two performance category scores will receive

[[Page 53899]]

a final score equal to the performance threshold, and this policy will 
apply in 2017 for MIPS eligible clinicians under the automatic extreme 
and uncontrollable circumstance policy.
    In the CY 2017 Quality Payment Program final rule (81 FR 77325 
through 77329), we adopted a policy for redistributing the weights of 
the performance categories in the final score for the 2017 performance 
period/2019 MIPS payment year. We stated that we envisioned that all 
MIPS eligible clinicians would have sufficient improvement activities 
applicable and available to them (81 FR 77323), and our policy did not 
include a scenario where a MIPS eligible clinician would not receive an 
improvement activities performance category score for 2017. With the 
addition of the automatic extreme and uncontrollable circumstance 
policy in this interim final rule with comment period, it is possible 
for a MIPS eligible clinician not to receive a score for the 
improvement activities performance category and for the category to be 
reweighted to zero percent in the final score; therefore, we need to 
modify our existing policy for redistributing the performance category 
weights for 2017 to account for this situation.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30144-
30146), we proposed a policy for redistributing the performance 
category weights for the 2018 performance period/2020 MIPS payment year 
based on our proposal to weight the cost performance category at zero 
percent of the final score. Although we are not finalizing these 
proposals, as explained in section II.C.7.b.(2) of the final rule with 
comment period, we will adopt this redistribution policy (reflected in 
Table 48) for the 2017 performance period/2019 MIPS payment year. This 
policy is the same as our existing policy for the transition year, but 
also accounts for the scenario where a MIPS eligible clinician has a 
score for the quality and advancing care information performance 
categories, but not an improvement activities performance category 
score; in this case we would redistribute the weight of the improvement 
activities performance category to the quality performance category.

           Table 48--Performance Category Redistribution Policies for CY 2017 MIPS Performance Period
----------------------------------------------------------------------------------------------------------------
                                                                     Reweight        Reweight        Reweight
                                                                  scenario if no  scenario if no  scenario if no
                                                   Weighting for  advancing care      quality       improvement
              Performance category                 the 2019 MIPS    information     performance     activities
                                                   payment year     performance      category       performance
                                                        (%)       category score   percent score  category score
                                                                        (%)             (%)             (%)
----------------------------------------------------------------------------------------------------------------
Quality.........................................              60              85               0              75
Cost............................................               0               0               0               0
Improvement Activities..........................              15              15              50               0
Advancing Care Information......................              25               0              50              25
----------------------------------------------------------------------------------------------------------------

D. APM Scoring Standard for MIPS Eligible Clinicians in MIPS APMs for 
the Transition Year

    In the CY 2017 Quality Payment Program final rule (81 FR 77246 
through 77269, 77543), we finalized the APM scoring standard, which is 
designed to reduce reporting burden for participants in certain APMs by 
minimizing the need for them to make duplicative data submissions for 
both MIPS and their respective APMs.
    We are not modifying the APM scoring standard policies that apply 
in 2017 for MIPS eligible clinicians who have been affected by extreme 
and uncontrollable circumstances. The cost performance category has 
been waived under the APM scoring standard (81 FR 77258, 77262, and 
77266). We will continue to apply the quality performance category 
scoring methodology described in section II.C.7.a.(2) of the final rule 
with comment period. The improvement activities performance category 
will continue to be automatically scored (81 FR 77266). The advancing 
care information performance category will be scored according to the 
policies described in section II.C.6.g.(3)(d) of the final rule with 
comment period for APM Entities scored under the APM scoring standard, 
which would include MIPS eligible clinicians in affected areas who 
qualify for a zero percent weighting of the advancing care information 
performance category under the automatic extreme and uncontrollable 
circumstance policy adopted in this interim final rule with comment 
period.

E. Waiver of Proposed Rulemaking for Provisions Related to Extreme and 
Uncontrollable Circumstances

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), 
the agency is required to publish a notice of the proposed rule in the 
Federal Register before the provisions of a rule take effect. 
Similarly, section 1871(b)(1) of the Act requires the Secretary to 
provide for notice of the proposed rule in the Federal Register and 
provide a period of not less than 60 days for public comment. Section 
553(b)(B) of the APA provides for exceptions from the notice and 
comment requirements; in cases in which these exceptions apply, section 
1871(b)(2)(C) of the Act provides for exceptions from the notice and 
60-day comment period requirements of the Act as well. Section 
553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an 
agency to dispense with normal rulemaking requirements for good cause 
if the agency makes a finding that the notice and comment process is 
impracticable, unnecessary, or contrary to the public interest.
    We find that there is good cause to waive the notice and comment 
requirements under sections 553(b)(B) of the APA and section 
1871(b)(2)(C) due to the impact of Hurricanes Harvey, Irma, and Maria 
as described in section III.A.3. of this interim final rule with 
comment period. Based on the size and scale of the destruction and 
displacement caused by these natural disasters in the regions 
identified in section III.A.3. of this interim final rule with comment 
period, we believe it is likely that some MIPS eligible clinicians have 
been significantly adversely affected by these events. It is possible 
that some MIPS eligible clinicians may have had to temporarily close 
their practice locations, or may lack access to their EHR technology or 
other data they would need to submit for MIPS for the 2017 performance 
period. We believe it is in the public interest to adopt these interim 
final policies to provide relief to impacted individual MIPS eligible

[[Page 53900]]

clinicians to assist them while they direct their resources toward 
caring for their patients and repairing structural damages to 
facilities.
    We find that it would be impracticable and contrary to the public 
interest to undergo notice and comment procedures before finalizing, on 
an interim basis with an opportunity for public comment, the policies 
described herein for individual MIPS eligible clinicians who have been 
affected by extreme and uncontrollable events that impact an entire 
region or locale. Therefore, we find good cause to waive the notice of 
proposed rulemaking as provided under section 1871(b)(2)(C) of the Act 
and section 553(b)(B) of the APA and to issue this interim final rule 
with an opportunity for public comment. We are providing a 60-day 
public comment period as specified in the DATES section of this 
document.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
publish a 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. To 
fairly evaluate whether an information collection should be approved by 
OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment 
on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our burden estimates.
     The quality, utility, and clarity of the information to be 
collected.
     Our effort to minimize the information collection burden 
on the affected public, including the use of automated collection 
techniques.
    We solicited public comment in the CY 2018 Quality Payment Program 
proposed rule on each of the required issues under section 
3506(c)(2)(A) of the PRA for the following information collection 
requirements (ICRs) (82 FR 30213 through 30230).

Summary and Overview

    In the CY 2017 Quality Payment Program final rule, we estimated a 
reduction of burden costs of $7.4 million relative to the legacy 
programs (PQRS and EHR Incentive Program for Eligible Professionals) it 
replaced (81 FR 77513). The streamlining and simplification of data 
submission structures in the transition year resulted in a reduction in 
burden relative to the approved information collections for the legacy 
programs. We estimate that the policies finalized in this final rule 
with comment period would result in further reduction of approximately 
171,264 burden hours and a further reduction in burden cost of 
approximately $13.9 million relative to a $708 million baseline of 
continuing the policies in the CY 2017 Quality Payment Program final 
rule.
    For our CY 2018 Quality Payment Program final rule with comment 
period burden estimates, we used several data sources. We used the 2017 
MIPS eligibility file and the initial QP determination file for the 
2017 Quality Payment Program performance year to account for which 
clinicians or groups would be excluded from or ineligible for MIPS, and 
which clinicians and groups would be exempt from the advancing care 
information performance category. We also used 2016 PQRS data and 2015 
and 2016 Medicare and Medicaid EHR Incentive Program data to estimate 
the number of participants (or respondents) for the performance 
categories.
    The Quality Payment Program Year 2 reduction in burden based on 
this final rule with comment period reflects our decision to finalize 
several proposed policies from the CY 2018 Quality Payment Program 
proposed rule, including our proposal for significant hardship or other 
type of exception, including a new significant hardship exception for 
small practices for the advancing care information performance 
category; our proposal to use a shorter version of the CAHPS for MIPS 
survey; and our proposal to allow MIPS eligible clinicians to form 
virtual groups which would create efficiencies in data submission. We 
chose to finalize the following proposals beginning with the CY 2019 
performance period rather than the CY 2018 performance period as 
proposed: Implementing facility based measurement (82 FR 30125) and 
allowing MIPS eligible clinicians (82 FR 30035 through 30035) to submit 
data via multiple submission mechanisms for a single performance 
category and these changes are reflected in our burden estimates.
    In addition to the decline in burden due to the policies proposed 
in this rule, we anticipate further reduction in burden because of 
policies set forth in the CY 2017 Quality Payment Program final rule, 
including greater clinician familiarity with the measures and data 
submission methods set in their second year of participation, 
operational improvements streamlining registration and data submission.
    We also see a decline in burden compared to the CY 2017 Quality 
Payment Program final rule based on the initial QP determination file, 
which we used to identify 100,649 QPs that would have otherwise 
reported as part of a group or as an individual clinician that will be 
excluded from MIPS in 2017 based on policies established in the CY 2017 
Quality Payment Program final rule. Our estimates assume clinicians who 
participated in the 2016 PQRS and who are not QPs in Advanced APMs in 
the 2017 Quality Payment Program performance period will continue to 
submit quality data as either MIPS eligible clinicians or voluntary 
reporters in the 2018 Quality Payment Program performance period. Our 
participation estimates are reflected in Table 54 for the quality 
performance category, Table 65 for the advancing information 
performance category, and Table 67 for the improvement activities 
performance category. We estimate that 35 percent of the estimated 
825,673 clinicians (288,986 clinicians) that are not subject to a MIPS 
payment adjustment in CY 2018, will report voluntarily and are included 
in our CY 2018 burden estimates because they reported previously under 
PQRS. We expect them to continue to submit because (a) the collection 
and submission of quality data has been integrated into their clinician 
practice; and (b) the clinician types that were ineligible from MIPS in 
the Quality Payment Program Years 1 and 2 may potentially become 
eligible in the future.
    We also assume that previous PQRS participants who are not QPs will 
also submit under the improvement activities performance category, and 
will submit under the advancing care information performance category 
unless they receive a significant hardship or other type of exception, 
including a new significant hardship exception for small practices or 
are automatically assigned a weighting of zero percent for the 
advancing care information performance category.
    Due to data limitations, these burden estimates may overstate the 
total burden for data submission under the quality, advancing care 
information, and improvement activities performance categories. Because 
of the total expected growth in Advanced APM participation, the 
estimated number of QPs excluded from our burden estimates based on 
data from the 2017 Quality Payment Program performance period (100,649) 
is lower than the summary level projection for the 2018 Quality Payment 
Program performance period based on the total expected growth in APM 
participation

[[Page 53901]]

(185,000 to 250,000).\28\ We use the QP determination file for the 
transition year because the performance year 2018 summary estimate was 
not available at the TIN/NPI level. The 185,000 to 250,000 eligible 
clinicians represent the projected range of QPs for the performance 
year 2018. We made our estimate of 100,649 using the TIN/NPIs of 
clinicians in the initial QP determination file for the transition 
year. Because we excluded QPs based on 2017 data, our burden estimates 
may be overestimating the number of clinicians that will submit MIPS 
data.
---------------------------------------------------------------------------

    \28\ 70,732 QPs were excluded from our analysis who did not meet 
any of the other MIPS exclusion or ineligibility criteria; in other 
words, they were eligible clinician types and exceeded the low-
volume threshold. An additional 29,917 QPs were excluded from our 
burden estimates who also met other MIPS exclusion or ineligibility 
criteria--that is they were not eligible clinician types or did not 
exceed the low-volume threshold.
---------------------------------------------------------------------------

    This total expected growth in Advanced APM participation is due in 
part to the addition of new participants in the CPC+ and Next 
Generation ACO models for 2018, and the start of the Medicare ACO Track 
1+ Model which is projected to have a large number of participants, 
with a large majority reaching QP status. Hence, our model may 
overestimate the numbers of clinicians and groups that will report data 
under the quality, advancing care information, and improvement 
activities performance categories.
    Our burden estimates assume that 35 percent of the 825,673 
clinicians who do not exceed the low-volume threshold or are not 
eligible clinician types (288,986) will voluntarily submit quality data 
under MIPS because they submitted quality data under the PQRS. Hence, 
the finalized changes in low-volume threshold will increase our 
estimate of the proportion of clinicians who will submit data 
voluntarily, but will not affect our overall burden estimate. As 
discussed in section II.C.2.c. of this final rule with comment period, 
we are finalizing at Sec.  414.1305 that clinicians or groups who have 
Medicare Part B allowed charges less than or equal to $90,000 or 
provide care for 200 or fewer Part B-enrolled Medicare beneficiaries 
are excluded from MIPS. The CY 2017 Quality Payment Program final rule 
established a low-volume threshold of less than or equal to $30,000 in 
allowed Medicare Part B charges or less than or equal to 100 Medicare 
patients (81 FR 77069).
    The revised MIPS requirements and burden estimates for all ICRs 
listed below (except for CAHPS for MIPS and virtual groups election) 
were submitted as a request for revision of OMB control number 0938-
1314. The CAHPS for MIPS ICR was submitted as a request for revision of 
OMB control number 0938-1222. Due to the statutory requirement for the 
virtual group election process to take place prior to the start of the 
2018 MIPS performance period, the information collection request for 
the virtual group election process was submitted for OMB review and 
approval separately from this rulemaking process and is assigned to OMB 
control number 0938-1343. Please note that the 60-day Federal Register 
notice was published on June 14, 2017 (82 FR 27257) and the related 
comment period ended on August 14, 2017. The 30-day Federal Register 
notice (82 FR 39440) was published August 18, 2017 announcing that we 
were formally submitting the information collection request to OMB and 
informing the public on its additional opportunity to review the 
information collection request and submit comments by September 18, 
2017. OMB approved the ICR on September 27, 2017.
    The following is a summary of general public comments received 
regarding our request for information on our information collections 
and our responses. We received several general comments regarding the 
burden of data collection.
    Comment: Several commenters supported CMS's efforts to reduce 
burden, including CMS's efforts to reduce burden for small practices or 
practices in rural areas, as well as the ability to form virtual 
groups. One commenter applauded CMS's efforts thus far, and urged CMS 
to go further to alleviate the burden placed on MIPS eligible 
clinicians participating in the Quality Payment Program.
    Response: We thank commenters for their support and will continue 
to work to reduce burden for MIPS eligible clinicians. To reduce 
burden, we are raising the low-volume threshold so that fewer 
clinicians in small practices are required to participate in the MIPS 
starting with the 2018 MIPS performance period; including bonus points 
for clinicians in small practices; adding a new significant hardship 
exception for the advancing care information performance category for 
MIPS eligible clinicians in small practices; implementing virtual 
groups, and extending the ability of MIPS eligible clinicians and 
groups to use 2014 Edition CEHRT while providing bonus points for the 
use of the 2015 Edition of CEHRT.
    Comment: Many commenters expressed concern that the Quality Payment 
Program is too burdensome and complex, and interferes with their 
ability to practice medicine. One commenter stated that burden 
estimates remain low by a factor of at least 10, and that the CY 2018 
Quality Payment Program proposed rule added more nuances and 
complications for clinicians and organizations. While this commenter 
did not specifically explain why they believe burden estimates are low 
by a factor of at least 10, they did explain that there are nuances 
involved with tracking and reporting multiple TINs and NPIs as groups 
or individuals which are specific to larger organizations and are not 
recognized as burdensome. Similarly, one commenter stated that the 
proposed requirements for the 2018 MIPS performance period are 
significantly more rigorous and burdensome than those in place for the 
2017 MIPS performance period. Several commenters cited the costly 
burden of documentation and paperwork to comply with requirements. One 
commenter shared concerns that the Quality Payment Program has evolved 
into a program that includes even more requirements, which continues to 
incentivize box-checking instead of actions that improve patient care.
    Response: In general, we believe that the changes in this final 
rule with comment period will improve the quality and value of care 
provided to Medicare beneficiaries. More broadly, we expect that, over 
time, clinician engagement in the Quality Payment Program may result in 
improved quality of patient care, resulting in lower morbidity and 
mortality. We believe the policies finalized in the CY 2017 Quality 
Payment Program final rule, as well as policies in this final rule with 
comment period will lead to additional growth in the participation of 
both MIPS APMS and Advanced APMs. APMs promote seamless integration by 
way of their payment methodology and design that incentivize such care 
coordination. We acknowledge clinician concerns with reporting burden 
and have tried to reduce burden where possible, while meeting the 
intent of the Act, including our obligations to improve patient 
outcomes.
    Further, absent specific information from the commenter as to why 
the commenter believes our burden estimates are low, we cannot 
specifically address commenter's burden concerns because no particular 
reference was made to any of the burden hours or costs provided across 
our burden estimate tables. Generally, we believe that our burden 
estimates provide a reasonable and appropriate assessment of burden on 
clinicians in the Quality Payment Program. Our estimates are grounded 
in reliable data

[[Page 53902]]

sources, our assumptions are based in past program methodologies 
including that of PQRS, and our analysis and justifications are 
detailed in this section of the final rule with comment period. In 
future program years, we anticipate that the burden will be reduced as 
eligible clinicians become more familiar with the requirements of the 
Quality Payment Program. Consistent with the requirements of the PRA, 
the burden estimates in this section of the final rule with comment 
period only include the costs of data submission and related record 
keeping. The Regulatory Impact Analysis section of this rule also 
includes estimates of the costs of reviewing this final rule with 
comment period. Therefore, we will not make any changes to the burden 
estimates as a result of these comments.
    Comment: A few commenters shared concerns regarding the complexity 
and burden of the CY 2018 Quality Payment Program proposed rule, citing 
implementation costs and concerns regarding the amount of effort needed 
to avoid Quality Payment Program negative payment adjustments. A few 
commenters cited a Medical Group Management Association (MGMA) report 
that summarized data from 750 group practices that volunteered to 
respond to a survey about the costs of complying with federal 
regulations.\29\ Among the 750 group practices responding to the 
survey, 82 percent rated Quality Payment Program as extremely or very 
burdensome. Further, study respondents were concerned with overall 
implementation costs related to their participation in MIPS. One 
commenter shared concerns that the Quality Payment Program positive 
payment adjustments available for the commenter's specialty do not 
cover the costs of compliance with MIPS quality reporting requirements. 
Another commenter noted that if the CY 2018 Quality Payment Program 
proposed rule is finalized as proposed, MIPS eligible clinicians will 
face even more rigorous and burdensome program requirements since MIPS 
eligible clinicians will need to report either complete data for at 
least 5 quality measures, fulfill all necessary improvement activities 
or report on all required advancing care information performance 
category measures, and score an additional 10 performance points (or a 
combination of these activities) to avoid negative payment adjustments.
---------------------------------------------------------------------------

    \29\ Medical Group Management Association. MGMA Regulatory 
Burden Survey, August 2016. https://www.mgma.com/getattachment/Government-Affairs/Advocacy/Advocacy-(1)/MGMA-2017-Regulatory-
Relief-Survey/MGMA-Regulatory-Relief-Survey-Results.pdf.
---------------------------------------------------------------------------

    Response: 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. We established special policies for the 
first year of the Quality Payment Program, which enabled a ramp-up and 
gradual transition with less financial risk for clinicians in the 
transition year. We called this approach ``pick your pace'' and allowed 
clinicians and groups to participate in MIPS through flexible means 
while avoiding a negative payment adjustment. In this final rule with 
comment period, we continue the slow ramp-up of the Quality Payment 
Program by establishing special policies for Quality Payment Program 
Year 2 aimed at encouraging successful participation in the program 
while reducing burden, and preparing clinicians for compliance with the 
2019 performance period (2021 payment year) statutory requirements.
    We are also finalizing that we will compare MIPS eligible 
clinicians' final scores against a MIPS performance threshold of 15 
points, which can be achieved via multiple pathways and continues the 
gradual transition into MIPS. While we acknowledge commenters' concerns 
that these more rigorous requirements for Quality Payment Program Year 
2 may lead to increased data submission burden, we clarify that our 
burden estimates in the CY 2017 Quality Payment Program final rule 
accounted for MIPS eligible clinicians choosing the full year 
participation option in MIPS with complete data submission (as opposed 
to reporting only the minimum 90 days of data required by the rule) for 
the 2017 performance period and, therefore, we did not adjust these 
estimates for this final rule with comment period. Further, we 
anticipate that the burden will be reduced as eligible clinicians 
become more familiar with the requirements of the Quality Payment 
Program.
    Because eligible clinicians will need to become familiar with the 
new requirements of this final rule with comment period, we will use 
our extensive outreach efforts to improve clinician understanding to 
the greatest extent possible. Additionally, in keeping with the 
objectives to provide education about the Quality Payment Program and 
maximize participation, and as authorized by section 1848(q)(11) of the 
Act, during a period of 5 years, $100 million in funding was provided 
for technical assistance to be available to provide guidance and 
assistance to MIPS eligible clinicians in small practices through 
contracts with regional health collaboratives, and others. Finally, the 
Regulatory Impact Analysis includes a general discussion of the 
potential costs to clinicians of meeting MIPS requirements, including 
implementation costs and the costs of reviewing this final rule with 
comment period. Consistent with the PRA, this section of the final rule 
with comment period only estimates the costs for submitting data 
(including reviewing measure specifications) and associated record 
keeping.
    After consideration of the public comments, we are not making any 
changes to our burden estimate methodology, but we are making changes 
to the burden to reflect the decisions to finalize the following 
proposals beginning with the CY 2019 performance period rather than the 
CY 2018 performance period as proposed: Implementing facility based 
measurement (82 FR 30125) and allowing MIPS eligible clinicians (82 FR 
30035 through 30035) to submit data via multiple submission mechanisms 
for a single performance category.
    We note that we are also adopting policies in an interim final rule 
with comment period that address extreme and uncontrollable 
circumstances MIPS eligible clinicians may face as a result of 
widespread catastrophic events affecting a region or locale in CY 2017, 
such as Hurricanes Irma, Harvey and Maria. We refer readers to section 
IV.P of this document for the collection of information requirements 
related to the interim final rule with comment period.

A. Wage Estimates

    To derive wage estimates, we used data from the U.S. Bureau of 
Labor Statistics' (BLS) May 2016 National Occupational Employment and 
Wage Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). Table 49 in this final rule with comment period 
presents the mean hourly wage (calculated at 100 percent of salary), 
the cost of fringe benefits and overhead, and the adjusted hourly wage.
    As indicated, we are adjusting our employee hourly wage estimates 
by a factor of 100 percent. This is necessarily a rough adjustment, 
both because fringe benefits and overhead costs vary significantly from 
employer to employer, and because methods of estimating these costs 
vary widely from study to study. Nonetheless, there is no practical 
alternative, and we believe that doubling the hourly wage to estimate 
total cost is a reasonably accurate estimation method. We have selected

[[Page 53903]]

the occupations in Table 49 based on a study (Casalino et al., 2016) 
that collected data on the staff in physician's practices involved in 
the quality data submission process.\30\
---------------------------------------------------------------------------

    \30\ Lawrence P. Casalino et al., ``US Physician Practices Spend 
More than $15.4 Billion Annually to Report Quality Measures,'' 
Health Affairs, 35, no. 3 (2016): 401-406.
---------------------------------------------------------------------------

    In addition, to calculate time costs for beneficiaries who elect to 
complete the CAHPS for MIPS survey, we have used wage estimates for 
Civilian, All Occupations, using the same BLS data discussed in the 
proposed rule (82 FR 30010). We have not adjusted these costs for 
fringe benefits and overhead because direct wage costs represent the 
``opportunity cost'' to beneficiaries themselves for time spent 
completing the survey. To calculate time costs for virtual groups to 
prepare their written formal agreements, we have used wage estimates 
for Legal Support Workers, All Others.

                            Table 49--Adjusted Hourly Wages Used in Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                      Fringe
                                                   Occupational     Mean hourly    benefits and      Adjusted
                Occupation title                       code        wage ($/hr.)    overhead ($/   hourly wage ($/
                                                                                       hr.)            hr.)
----------------------------------------------------------------------------------------------------------------
Billing and Posting Clerks......................         43-3021          $18.06          $18.06          $36.12
Computer Systems Analysts.......................         15-1121           44.05           44.05           88.10
Physicians......................................         29-1060          101.04          101.04          202.08
Practice Administrator (Medical and Health               11-9111           52.58           52.58          105.16
 Services Managers).............................
Licensed Practical Nurse (LPN)..................         29-2061           21.56           21.56           43.12
Legal Support Workers, All Other................         23-2099           31.81           31.81           63.62
Civilian, All Occupations.......................  Not applicable           23.86             N/A           23.86
----------------------------------------------------------------------------------------------------------------
Source: Occupational Employment and Wage Estimates May 2016, U.S. Department of Labor, Bureau of Labor
  Statistics. https://www.bls.gov/oes/current/oes_nat.htm.

B. Framework for Understanding the Burden of MIPS Data Submission

    Because of the wide range of information collection requirements 
under MIPS, Table 50 presents a framework for understanding how the 
organizations permitted or required to submit data on behalf of 
clinicians varies across the types of data, and whether the clinician 
is a MIPS eligible clinician, MIPS APM participant, or an Advanced APM 
participant. As shown in the first row of Table 50, MIPS eligible 
clinicians that are not in MIPS APMs and other clinicians voluntarily 
submitting data will submit data either as individuals, groups, or 
virtual groups, as applicable, to the quality, advancing care 
information, and improvement activities performance categories. Because 
the cost performance category relies on administrative claims data, 
MIPS eligible clinicians are not requested to provide any additional 
information and therefore claims data is not represented in Table 50.
    For MIPS APMs, the organizations submitting data on behalf of 
participating MIPS eligible clinicians will vary across categories of 
data, and in some instances across APMs. For the 2018 MIPS performance 
period, the quality data submitted by Shared Savings Program ACOs, Next 
Generation ACOs, and APM Entities in Other MIPS APMs on behalf of their 
participant MIPS eligible clinicians will fulfill any MIPS submission 
requirements for the quality performance category.
    For the advancing care information performance category, billing 
TINs will submit data on behalf of participants who are MIPS eligible 
clinicians. For the improvement activities performance category, we 
will assume no reporting burden for MIPS APM participants. In the CY 
2017 Quality Payment Program final rule, we describe how we determine 
MIPS APM scores (81 FR 77185). We compare the requirements of the 
specific MIPS APM with the list of activities in the Improvement 
Activities Inventory and score those activities in the same manner that 
they are otherwise scored for MIPS eligible clinicians. If, by our 
assessment, the MIPS APM does not receive the maximum improvement 
activities performance category score then the APM Entity can submit 
additional improvement activities. We assume that MIPS APMs available 
for the CY 2018 MIPS performance period will receive the maximum 
improvement activities performance category score, and therefore, will 
not require the APM Entity to submit additional improvement activities. 
Advanced APM participants who are determined to be Partial QPs may 
incur additional burden if they elect to participate in MIPS, which is 
discussed in more detail in section II.D.5. of this final rule with 
comment period.

[[Page 53904]]



Table 50--Clinicians or Organizations Submitting MIPS Data on Behalf of Clinicians, by Type of Data and Category
                                                 of Clinician *
----------------------------------------------------------------------------------------------------------------
                                                                                                  Other data
                                        Quality         Advancing care        Improvement        submitted on
      Category of clinician           performance         information         activities        behalf of MIPS
                                       category           performance         performance          eligible
                                                           category            category           clinicians
----------------------------------------------------------------------------------------------------------------
                                             Type of Data Submitted
----------------------------------------------------------------------------------------------------------------
MIPS Eligible Clinicians (not in  As group, virtual   As group, virtual   As group, virtual   Groups electing to
 MIPS APMs) and Other Clinicians   groups, or          groups, or          groups, or          use a CMS-
 Voluntarily Submitting Data       individual          individuals.        individual          approved survey
 \31\.                             clinicians.         Clinicians who      clinicians.         vendor to
                                                       practice                                administer CAHPS
                                                       primarily in a                          must register.
                                                       hospital,                               Groups electing
                                                       ambulatory                              to submit via CMS
                                                       surgical center                         Web Interface for
                                                       based clinicians,                       the first time
                                                       non-patient                             must register.
                                                       facing                                  Virtual groups
                                                       clinicians, PAs,                        must register via
                                                       NPs, CNSs and                           email.
                                                       CRNAs are
                                                       automatically
                                                       eligible for a
                                                       zero percent
                                                       weighting for the
                                                       advancing care
                                                       information
                                                       performance
                                                       category.
                                                       Clinicians
                                                       approved for
                                                       significant
                                                       hardship
                                                       exceptions are
                                                       also eligible for
                                                       a zero percent
                                                       weighting.
Eligible Clinicians               ACOs submit to the  Each group TIN in   CMS will assign     Advanced APM
 participating in the Shared       CMS Web Interface   the APM Entity      the improvement     Entities will
 Savings Program or Next           and CAHPS for       reports advancing   activities          make election for
 Generation ACO Model (both MIPS   ACOs on behalf of   care information    performance         participating
 APMs).                            their               to MIPS.\33\.       category score to   MIPS eligible
                                   participating                           each APM Entity     clinicians.
                                   MIPS eligible                           group based on
                                   clinicians. [Not                        the activities
                                   included in                             involved in
                                   burden estimate                         participation in
                                   because quality                         the Shared
                                   data submission                         Savings
                                   to fulfill                              Program.\34\ [The
                                   requirements of                         burden estimates
                                   the Shared                              assume no
                                   Savings Program                         improvement
                                   and Next                                activity
                                   Generation ACO                          reporting burden
                                   models are not                          for APM
                                   subject to the                          participants
                                   PRA].\32\.                              because we assume
                                                                           the MIPS APM
                                                                           model provides a
                                                                           maximum
                                                                           improvement
                                                                           activity
                                                                           performance
                                                                           category score.].
Eligible Clinicians               MIPS APM Entities   Each MIPS eligible  CMS will assign     Advanced APM
 participating in Other MIPS       submit to MIPS on   clinician in the    the same            Entities will
 APMs.                             behalf of their     APM Entity          improvement         make election for
                                   participating       reports advancing   activities          participating
                                   MIPS eligible       care information    performance         eligible
                                   clinicians [Not     to MIPS through     category score to   clinicians.
                                   included in         either group TIN    each APM Entity
                                   burden estimate     or individual       based on the
                                   because quality     reporting. [The     activities
                                   data submission     burden estimates    involved in
                                   to fulfill          assume group TIN-   participation in
                                   requirements of     level reporting].   the MIPS APM.
                                   Innovation Center                       [The burden
                                   models are not                          estimates assume
                                   subject to the                          no improvement
                                   PRA.].                                  activities
                                                                           performance
                                                                           category
                                                                           reporting burden
                                                                           for APM
                                                                           participants
                                                                           because we assume
                                                                           the MIPS APM
                                                                           model provides a
                                                                           maximum
                                                                           improvement
                                                                           activity score.].
----------------------------------------------------------------------------------------------------------------
* Because the cost performance category relies on administrative claims data, MIPS eligible clinicians are not
  requested to provide any additional information and therefore claims data is not represented in this table.

    The policies finalized in the CY 2017 Quality Payment Program final 
rule and this final rule with comment period

[[Page 53905]]

create some additional data collection requirements not listed in Table 
50. These additional data collections, some of which were previously 
approved by OMB under control numbers 0938-1314 and 0938-1222 are as 
follows:
---------------------------------------------------------------------------

    \31\ Virtual group participation is limited to MIPS eligible 
clinicians, specifically, solo practitioners and groups consisting 
of 10 eligible clinicians or fewer.
    \32\ Sections and 3021 and 3022 of the Affordable Care Act state 
the Shared Savings Program and testing, evaluation, and expansion of 
Innovation Center models are not subject to the PRA (42 U.S.C. 
1395jjj and 42 U.S.C. 315a(d)(3), respectively).
    \33\ For MIPS APMs other than the Shared Savings Program, both 
group TIN and individual clinician advancing care information data 
will be accepted. If both group TIN and individual scores are 
submitted for the same MIPS APM Entity, CMS would take the higher 
score for each TIN/NPI. The TIN/NPI scores are then aggregated for 
the APM Entity score.
    \34\ APM Entities participating in MIPS APMs do not need to 
submit improvement activities data unless the CMS-assigned 
improvement activities scores are below the maximum improvement 
activities score.
---------------------------------------------------------------------------

     Self-nomination of new and returning QCDRs and registries 
(0938-1314).
     CAHPS for MIPS survey completion by beneficiaries (0938-
1222).
     Approval process for new and returning CAHPS for MIPS 
survey vendors.
     Call for new improvement activities (see section 
II.C.6.e.(7) of this final rule with comment period).
     Call for new advancing care information measures.
     Other Payer Advanced APM determinations: Payer Initiated 
Process.
     Opt out of performance data display on Physician Compare 
for voluntary reporters under MIPS.
    We did not receive comments specific to our framework for 
understanding the burden of MIPS data submission.

C. ICR Regarding Burden for Virtual Group Election (Sec.  414.1315)

    As described in section II.C.4.b. of this final rule with comment 
period, virtual groups are defined by a combination of 2 or more TINs 
and must report as a virtual group on measures in all quality, 
improvement activities, and advancing care information performance 
categories as virtual groups. Virtual groups may submit data through 
any of the mechanisms available to groups. We refer to section II.C.4. 
of this final rule with comment period on additional requirements for 
virtual groups.
    In section II.C.4.e. of this final rule with comment period, we are 
establishing an optional 2-stage process for enrollment. In stage 1, 
MIPS eligible clinicians have the option to request a determination of 
their eligibility to form a virtual group before they form a group and 
begin the stage 2 submission of an election to participate in a virtual 
group. For clinicians or groups that do not choose to participate in 
stage 1 of the election process, we will make an eligibility 
determination during stage 2 of the election process. We refer readers 
to section II.C.4.e. of this final rule with comment period for a 
discussion of the finalized virtual group election process.
    As established in section II.C.4.e. of this final rule with comment 
period, the submission of a virtual group election must include, at a 
minimum, detailed information pertaining to each TIN and NPI associated 
with the virtual group and detailed information for the virtual group 
representative, as well as confirmation of a written formal agreement 
between members of the virtual group at the TIN level.
    We assume that virtual group participation will be relatively low 
in the first year because we have heard from stakeholders that they 
need at least 3 to 6 months to form groups and establish agreements 
before signing up. We are not able to give them that much time in the 
first year, rather closer to 60 days. Because of this, we expect the 
number of virtual groups will be very small in the first year of 
virtual group implementation. Our assumptions for participation in a 
virtual group are shown in Table 51. We assume that only those eligible 
clinicians that reported historically will participate in virtual 
groups in the first year because of the limited lead time to create 
processes. Also, while virtual groups may use the same submission 
mechanisms as groups, we are estimating based on stakeholder feedback 
that the 16 virtual groups reflected in Table 51 will report by 
registry. Table 51 also shows that we estimate that approximately 765 
MIPS eligible clinicians will decide to join 16 virtual groups for the 
2018 MIPS performance period. We assumed each of the 16 virtual groups 
would consist of approximately 5 TINs (765 MIPS eligible clinicians / 
48 eligible clinicians per virtual group) or 80 TINs total that will 
participate in virtual groups (16 virtual groups x 5 MIPS eligible 
clinicians per TIN).
    We assume that the virtual election process will require 10 hours 
per virtual group, similar to the burden of the QCDR or registry self-
nomination process finalized in Sec.  414.1400. We assume that 8 hours 
of the 10 burden hours per virtual group will be computer systems 
analyst's time or the equivalent with an average labor cost of $88.10/
hour, and an estimated cost of $704.80 per virtual group ($88.10/hour x 
8 hours). We also assume that 2 hours of the 10 burden hours per 
virtual group will be legal support services professionals assisting in 
formulating the written virtual agreement with an average labor cost of 
$63.62/hour, with a cost of $127.24 per virtual group ($63.62/hour x 2 
hours). Therefore, the total burden cost per virtual group associated 
with the election process is $832.04 ($704.80 + $127.24). We also 
assume that 16 new virtual groups will go through the election process 
leading to a total burden of $13,313 ($832.04 x 16 virtual groups). We 
estimate that the total annual burden hours will be 160 (16 virtual 
groups x 10 hours).

      Table 51--Estimated Burden for Virtual Group Election Process
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Estimated Number of MIPS eligible clinicians in                765
 TINs of 10 eligible clinicians or fewer submitting data
 in MIPS (a)............................................
Total Estimated Number of eligible TINs (10 eligible                  80
 clinicians or fewer) (b)...............................
Estimated # of virtual groups (c).......................              16
Estimated Total Annual Burden Hours for virtual group to               2
 prepare written formal agreement (d)...................
Estimated Total Annual Burden Hours for Virtual Group                  8
 Representative to submit application to form a virtual
 group (e)..............................................
Estimated Total Annual Burden Hours per virtual group                 10
 (f)....................................................
Estimated Total Annual Burden Hours for virtual groups               160
 (g) = (c) * (f)........................................
Estimated Cost to prepare formal written agreement               $127.24
 (@legal support services professional's labor rate of
 $63.62) (h)............................................
Estimated Cost to elect per virtual group (@computer             $704.80
 systems analyst's labor rate of $88.10/hr.) (i)........
Estimated Total Annual Burden Cost per virtual group (j)         $832.04
Estimated Total Annual Burden Cost (k) = (c) * (j)......         $13,313
------------------------------------------------------------------------

    While the formation of virtual groups will result in a burden for 
virtual group registration, we also estimate that the formation of 
virtual groups will result in a decline in burden from other forms of 
data submission. Because we assume burden is the same for each 
organization (group, virtual group, or eligible clinician) submitting 
quality, improvement activities or advancing care information 
performance category data, virtual groups will reduce burden by 
reducing the time needed to prepare data for submission, review measure 
specifications, register or elect to submit data via a mechanism such 
as QCDR, registry, CMS Web Interface, or EHR. This reduction in burden 
is described in

[[Page 53906]]

each of the quality, improvement activities, and advancing care 
information performance category sections below. There is no burden 
represented for the cost performance category because administrative 
claims data is used to collect information on cost measures from MIPS 
eligible clinicians.
    As stated earlier, the information collection request for the 
virtual group election process was reviewed and approved by OMB (0938-
1343) separately from this rulemaking process. We announced the 
opportunity for the public to comment on the virtual group election 
process via a 60-day Federal Register notice published on June 14, 2017 
(82 FR 27257) and a 30-day Federal Register notice published August 18, 
2017 (82 FR 39440-39442).
    The following is a summary of the public comments received 
regarding our request for on the 2018 Quality Payment Program proposed 
rule regarding our estimated burden for the virtual group election 
process.
    Comment: One commenter believed that CMS underestimated the time 
and cost involved in making the decision to form and create a virtual 
group. The commenter noted that the estimated 10 burden hours per 
virtual group election included 8 hours for computer systems analysts 
and 2 hours for legal support but no allocation of costs for clinician 
time, which could be substantial since many clinicians own small 
practices and are closely involved with such business decisions. The 
commenter believed that the burden for a virtual group to comply with 
MIPS reporting requirements would be greater than the 10 estimated 
hours required for virtual group election and noted the potential added 
burden associated with a virtual group reporting as a group due to the 
potential heterogeneity within the groups involved.
    Response: To clarify, we are assuming that the time to submit data 
via a virtual group would include the 10 burden hours per group to 
elect to become a virtual group, and then the additional time required 
to submit data for the quality, advancing care information, and 
improvement activities performance categories. The reduction in burden 
is due to the MIPS eligible clinicians, who are forming the virtual 
group, and then reporting at a more consolidated level. We understand 
that clinicians may need to spend time (1) becoming familiar with the 
requirements to form a virtual group and (2) making a decision about 
whether to form a virtual group. Further, they may incur costs as a 
result of those activities. However, we do not anticipate that the 
clinicians will be responsible for the activities that are included in 
our burden estimate for virtual group election--the drafting and 
submission of the virtual group application via email and any 
associated recordkeeping. We acknowledge that if practices of 
heterogeneous specialists form a virtual group, it may result in that 
virtual group reporting more than 6 measures. We anticipate that most 
virtual groups will involve only 1 specialty. Consistent with the PRA, 
costs associated with forming a virtual group as well as the time spent 
on day-to-day clinical practice activities and on coordination across 
virtual group members are not included in our burden estimates.
    After considerations of public comments, we are making no changes 
to our virtual group election process burden estimates as a result of 
public comments received. The burden estimates have not been updated 
from the CY 2018 Quality Payment Program proposed rule (82 FR 2013).

D. ICR Regarding Burden for Election of Facility-Based Measurement

    Because we are not finalizing the policy to allow facility-based 
measurement until the 2019 MIPS performance period, we have revised our 
burden estimates to include back into our quality performance category 
data submission burden estimates 17,943 eligible clinicians who 
practice primarily in the hospital that did not submit under the 2017 
MIPS performance period that would have elected facility-based 
measurement as individuals in the 2018 MIPS performance period. We also 
revised our burden estimates to include back into our quality 
performance category data submission burden estimates 264 groups who 
practice primarily in the hospital that previously submitted as groups 
under the 2017 MIPS performance period that we projected would have 
elected facility-based measurement in the 2018 MIPS performance period. 
We also removed the burden estimate of 1 hour of a billing clerk's time 
at $36.12/hr. for each of these individuals or groups that would have 
otherwise elected facility-based measurement or a total annual burden 
cost of $657,637 (18,207 x $36.12) for the election process to 
participate in facility-based measurement.

E. ICRs Regarding Burden for Third-Party Reporting (Sec.  414.1400)

    Under MIPS, quality, advancing care information, and improvement 
activities performance categories' data may be submitted via relevant 
third-party intermediaries, such as qualified registries, QCDRs and 
health IT vendors. The CAHPS for MIPS survey data, which counts as one 
quality performance category measure, can be submitted via CMS-approved 
survey vendors. The burdens associated with qualified registry and QCDR 
self-nomination and the CAHPS for MIPS survey vendor applications are 
discussed below.
1. Burden for Qualified Registry and QCDR Self-Nomination \35\
---------------------------------------------------------------------------

    \35\ We do not anticipate any changes in the CEHRT process for 
health IT vendors as we transition to MIPS. Hence, health IT vendors 
are not included in the burden estimates for MIPS.
---------------------------------------------------------------------------

    For the 2017 MIPS performance period, 120 qualified registries and 
113 QCDRs were qualified to report quality measures data for purposes 
of the PQRS, an increase from 114 qualified registries and 69 QCDRs in 
CY 2016.\36\ For purposes of the 2018 MIPS performance period, we 
estimate the same number of qualified registries and QCDRs, for a total 
of 233, although we believe that the number of QCDRs and qualified 
registries will continue to increase because: (1) Many MIPS eligible 
clinicians will be able to use the qualified registry and QCDR for all 
MIPS submissions (not just for quality submission), and (2) QCDRs will 
be able to provide innovative measures that address practice needs. 
Qualified registries or QCDRs interested in submitting quality measure 
results and numerator and denominator data on quality measures to us on 
their participants' behalf will need to complete a self-nomination 
process to be considered to be qualified to submit on behalf of MIPS 
eligible clinicians or groups.
---------------------------------------------------------------------------

    \36\ The full list of qualified registries for 2017 is available 
at https://qpp.cms.gov/docs/QPP_MIPS_2017_Qualified_Registries.pdf 
and the full list of QCDRs is available at https://qpp.cms.gov/docs/QPP_2017_CMS_Approved_QCDRs.pdf.
---------------------------------------------------------------------------

    In sections II.C.10.b.(2)(b) and II.C.10.d.(2)(b) of this final 
rule with comment period, we finalized our proposals with clarification 
that previously approved QCDRs and qualified registries in good 
standing (that are not on probation or disqualified) that wish to self 
nominate using the simplified process can attest, in whole or in part, 
that their previously approved form is still accurate and applicable . 
We clarified our proposals by elaborating on what would be required for 
previously approved entities in good standing that wish to self-
nominate and have minimal or substantive changes. As we discussed in 
II.C.10.d.(2)(b)(i) and (ii) of this final rule with comment period, 
existing

[[Page 53907]]

QCDRs in good standing with no changes may attest during the self-
nomination period, between September 1 and November 1, that they have 
no changes to their approved self-nomination application from the 
previous year of MIPS. Existing QCDRs in good standing that would like 
to make minimal changes to their previously approved self-nomination 
application from the previous year, may submit these changes, and 
attest to no other changes from their previously approved QCDR 
application, for CMS review during the self-nomination period, from 
September 1 to November 1. This simplified self-nomination process 
would begin for the 2019 MIPS performance period. For purposes of 2018 
MIPS performance period, we assume all qualifying registries and QCDRs 
will go through the current process.
    We estimate that the self-nomination process for qualified 
registries or QCDRs to submit on behalf of MIPS eligible clinicians or 
groups for MIPS will involve approximately 1 hour per qualified 
registry or QCDR to complete the online self-nomination process. The 
self-nomination form is submitted electronically using a web-based 
tool. We proposed to eliminate the option of submitting the self-
nomination form via email that was available in the transition year.
    In addition to completing a self-nomination statement, qualified 
registries and QCDRs will need to perform various other functions, such 
as meeting with CMS officials when additional information is needed. In 
addition, QCDRs calculate their measure results. QCDRs must possess 
benchmarking capability (for QCDR measures) that compares the quality 
of care a MIPS eligible clinician provides with other MIPS eligible 
clinicians performing the same quality measures. For QCDR measures the 
QCDR must provide to us, if available, data from years prior (for 
example, 2016 data for the 2018 MIPS performance period) before the 
start of the performance period. In addition, the QCDR must provide to 
us, if available, the entire distribution of the measure's performance 
broken down by deciles. As an alternative to supplying this information 
to us, the QCDR may post this information on their Web site prior to 
the start of the performance period, to the extent permitted by 
applicable privacy laws. The time it takes to perform these functions 
may vary depending on the sophistication of the entity, but we estimate 
that a qualified registry or QCDR will spend an additional 9 hours 
performing various other functions related to being a MIPS qualified 
registry or QCDR.
    As shown in Table 52, we estimate that the staff involved in the 
qualified registry or QCDR self-nomination process will mainly be 
computer systems analysts or their equivalent, who have an average 
labor cost of $88.10/hour. Therefore, assuming the total burden hours 
per qualified registry or QCDR associated with the self-nomination 
process is 10 hours, the annual burden hours is 2,330 ((113 QCDRs + 120 
qualified registries) x 10 hours). We estimate that the total cost to a 
qualified registry or QCDR associated with the self-nomination process 
will be approximately $881.00 ($88.10 per hour x 10 hours per qualified 
registry). We also estimate that 233 qualified registries or QCDRs will 
go through the full self-nomination process leading to a total burden 
of $205,273 ($881.00 x 233).
    Qualified registries and QCDRs must comply with requirements on the 
submission of MIPS data to CMS. The burden associated with the 
qualified registry and QCDR submission requirements will be the time 
and effort associated with calculating quality measure results from the 
data submitted to the qualified registry or QCDR by its participants 
and submitting these results, the numerator and denominator data on 
quality measures, the advancing care information performance category, 
and improvement activities data to us on behalf of their participants. 
We expect that the time needed for a qualified registry to accomplish 
these tasks will vary along with the number of MIPS eligible clinicians 
submitting data to the qualified registry or QCDR and the number of 
applicable measures. However, we believe that qualified registries and 
QCDRs already perform many of these activities for their participants. 
We believe the estimate noted in this section represents the upper 
bound of QCDR burden, with the potential for less additional MIPS 
burden if the QCDR already provides similar data submission services.
    Based on the assumptions previously discussed, we provide an 
estimate of total annual burden hours and total annual cost burden 
associated with a qualified registry or QCDR self-nominating to be 
considered ``qualified'' to submit quality measures results and 
numerator and denominator data on MIPS eligible clinicians.

    Table 52--Estimated Burden for QCDR and Qualified Registry Self-
                               Nomination
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Estimated # of Qualified registries or QCDRs Self-                   233
 Nominating (a).........................................
Estimated Total Annual Burden Hours Per Qualified                     10
 Registry or QCDR (b)...................................
Estimated Total Annual Burden Hours for Qualified                  2,330
 Registries or QCDRs (c) = (a) * (b)....................
Estimated Cost Per Qualified Registry or QCDR (@computer         $881.00
 systems analyst's labor rate of $88.10/hr.) (d)........
Estimated Total Annual Burden Cost for Qualified                $205,273
 registries or QCDRs (e) = (a) * (d)....................
------------------------------------------------------------------------

    The following is a summary of the public comments received on our 
estimated burden for QCDR and registry self-nomination.
    Comment: One commenter shared concerns that the process of revising 
and changing measures during a QCDR-vendor application window is quite 
burdensome and costly, as are incorporating any changes within each 
practice and facility. The commenter stated that the estimate of 10 
hours to complete and submit a QCDR-vendor application is significantly 
under-valued or incomplete, and it is unclear whether this estimate 
included the follow-up changes and discussions QCDRs must also undergo 
subsequent to the self-nomination's submission. This is a very labor-
intensive process and the potential technological changes required to 
gain approval can be very costly to the QCDR vendor.
    Response: We acknowledge the commenter's concern regarding burden 
and cost for QCDR measure revisions and the self-nomination process. 
Our burden estimates consider the time associated with submitting the 
application, but do not include direct financial costs such as those 
related to measure revisions and updates. Our burden estimates do 
incorporate time estimates regarding the self-nomination application 
and recordkeeping,

[[Page 53908]]

including follow-up changes and discussions QCDRs must also undergo 
subsequent to the self-nomination's submission.
    We assume that many of the QCDRs that previously participated in 
the self-nomination process for the CY 2017 Quality Payment Program 
will do so again for the CY 2018 Quality Payment Program and will not 
need to have as many follow-up discussions as in the previous year. 
However, because the estimate is an average, we maintained our estimate 
of 10 hours which we included in our CY 2017 burden estimates even 
though we believe continuing QCDRs will need fewer hours. The burden 
estimates in this section addresses time costs of data collection, not 
direct financial costs such as those related to measure updating.
    After consideration of public comments, no changes were made to our 
estimated burden for QCDR and registry self-nomination compared to 
those presented in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30216).

2. Burden for CMS-Approved Survey Vendors

    In the CY 2017 Quality Payment Program final rule (81 FR 77386), we 
finalized the definition, criteria, required forms, and vendor business 
requirements needed to participate in MIPS as a survey vendor. For 
purposes of MIPS, we defined a CMS-approved survey vendor at Sec.  
414.1305 as a survey vendor that is approved by us for a particular 
performance period to administer the CAHPS for MIPS survey and transmit 
survey measures data to us (81 FR 77386). At Sec.  414.1400(i), we 
require that vendors undergo the CMS-approval process each year in 
which the survey vendor seeks to transmit survey measures data to us 
(81 FR 77386). We finalized the criteria for a CMS-approved survey 
vendor for the CAHPS for MIPS survey (81 FR 77386). In section 
II.C.10.e.(1) of this final rule with comment period, we finalized that 
beginning with the 2018 performance period and for future years, the 
vendor application deadline will be January 31st of the applicable 
performance year or a later date specified by CMS, which we do not 
anticipate would have any burden impact on the CMS-approved survey 
vendors.
    We estimate that approximately 15 CMS-approved survey vendors will 
apply for the 2018 MIPS performance period. We estimate that it will 
take a survey vendor 10 hours to submit the information required for 
the CMS-approval process, including the completion of the Vendor 
Participation Form and compiling documentation, including the quality 
assurance plan, that demonstrates that they comply with Minimum Survey 
Vendor Business Requirements. This is comparable to the burden of the 
QCDR and qualified registry self-nomination process. As shown in Table 
53, we assume that the survey vendor staff involved in collecting and 
submitting the information required for the CAHPS for MIPS 
certification will be computer systems analysts, who have an average 
labor cost of $88.10/hour. Therefore, assuming the total burden hours 
per CAHPS associated with the application process is 10 hours, the 
annual burden hours is 150 (15 survey vendors x 10 hours). We estimate 
that the total cost to each survey vendor associated with the 
application process will be approximately $881.00 ($88.10 per hour x 10 
hours per survey vendor). We estimate that 15 survey vendors will go 
through the process leading to a total burden of $13,215 ($881.00 x 15 
survey vendors).
    Based on the assumptions previously discussed, we provide an 
estimated number of total annual burden hours and total annual cost 
burden associated with the survey vendor approval process in Table 53.

  Table 53: Estimated Burden for CMS-Approved Survey Vendor Application
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Estimated # of New Survey Vendors Applying (a)..........              15
Estimated # of Burden Hours Per Vendor to Apply (b).....              10
Estimated Cost Per Vendor Reporting (@computer systems           $881.00
 analyst's labor rate of $88.10/hr.) (c)................
Estimated Total Annual Burden Hours (d) = (a) * (b).....             150
Estimated Total Annual Burden Cost for Survey Vendor             $13,215
 Application Process (e) = (a) * (c)....................
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
the CMS-approved survey vendor application. The burden estimates have 
not been updated from the CY 2018 Quality Payment Program proposed 
rule(82 FR 30216).

F. ICRs Regarding the Quality Performance Category (Sec.  414.1330 and 
Sec.  414.1335)

    Two groups of clinicians will submit quality data under MIPS: Those 
who submit as MIPS eligible clinicians and other eligible clinicians 
who opt to submit data voluntarily but will not be subject to MIPS 
payment adjustments.
    Historically, the PQRS has never experienced 100 percent 
participation; the participation rate for 2015 was 69 percent.\37\ For 
purposes of these analyses, we assume that a total of 892,992 
clinicians who participated in the 2016 PQRS and who are not QPs in 
Advanced APMs in the 2017 Quality Payment Program performance period 
will continue to submit quality data as either MIPS eligible clinicians 
(604,006) or voluntary reporters (288,986) in the 2018 MIPS performance 
period. Based on 2016 data from the PQRS, and 2017 MIPS eligibility 
data and 2017 QP determination data, we estimate that a minimum of 90 
percent of MIPS eligible clinicians not participating in MIPS APMs will 
submit quality performance category data including those participating 
as individual clinicians, groups, or virtual groups. We assume that 100 
percent of APM Entities in MIPS APMs will submit quality data to CMS as 
required under their models.\38\ We anticipate that the professionals 
submitting data voluntarily will include clinicians that are ineligible 
for the Quality Payment Program, clinicians that do not exceed the low-
volume threshold, and newly enrolled Medicare clinicians. Based on 
those assumptions, using 2017 MIPS eligibility data file and data from 
the 2016 PQRS, we estimate that an additional 288,986 clinicians, or 35 
percent of clinicians excluded from or ineligible from MIPS, will 
submit

[[Page 53909]]

MIPS quality data voluntarily. Because of the exclusion of QPs from our 
burden estimates, we are predicting a decline in the rate of voluntary 
quality data submission among clinicians excluded from or ineligible 
for MIPS relative to our estimated voluntary reporting rate of 44 
percent in the CY 2017 Quality Payment Program final rule (81 FR77501). 
Historically, clinicians who are expected to be QPs in 2018 MIPS 
performance period were much more likely to have submitted quality data 
under the 2016 PQRS than other clinicians excluded from or ineligible 
from MIPS. Due to data limitations, our assumptions about quality 
performance category participation for the purposes of our burden 
estimates differs from our assumptions about quality performance 
category participation in the impact analysis.\39\
---------------------------------------------------------------------------

    \37\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2015_PQRS_Experience_Report.pdf.
    \38\ We estimate that 100,649 clinicians that participated in 
the 2016 PQRS will be QPs who will not be not required to submit 
MIPS quality performance category data under MIPS, and are not 
included in the numerator or denominator of our participation rate.
    \39\ As noted, the COI section of this rule uses the actual 
overall average participation rate of 92 percent in quality data 
submission based on 2015 PQRS data. The RIA section of this rule 
uses the actual participation rate for practices with more than 15 
clinicians and assumes a minimum 90 percent participation (standard 
assumption or 80 percent participation (alternative assumption) for 
practices with 1-15 clinicians.
---------------------------------------------------------------------------

    Our burden estimates for data submission combine the burden for 
MIPS eligible clinicians and other clinicians submitting data 
voluntarily. Apart from clinicians that became QPs in the first QP 
performance period, we assume that clinicians will continue to submit 
quality data under the same submission mechanisms that they used under 
the 2016 PQRS. Further, as discussed in more detail in section IV.C. of 
this final rule with comment period when describing the burden for the 
virtual group application process, we assume that the approximately 80 
TINs that elect to form the approximately 16 virtual groups will 
continue to use the same submission mechanism as they did when 
reporting under the 2016 PQRS, but the submission will be at the 
virtual group, rather than group level. Our burden estimates for the 
quality performance category do not include the burden for the quality 
data that APM Entities in MIPS APMs submit to fulfill the requirements 
of their models. Sections 3021 and 3022 of the Affordable Care Act 
state the Shared Savings Program and the testing, evaluation, and 
expansion of Innovation Center models are not subject to the PRA (42 
U.S.C. 1395jjj and 42 U.S.C. 1315a(d)(3), respectively).\40\ Tables 54, 
55, and 56 explain our revised estimates of the number of organizations 
(including groups, virtual groups, and individual MIPS eligible 
clinicians) submitting data on behalf of clinicians via each of the 
quality submission mechanisms.
---------------------------------------------------------------------------

    \40\ Our estimates do reflect the burden that MIPS APM 
participants of submitting advancing care information data, which is 
outside the requirements of their models.
---------------------------------------------------------------------------

    Table 54 provides our estimated counts of clinicians that will 
submit quality performance category data as MIPS individual clinicians, 
groups, or virtual groups in the 2018 MIPS performance period. The 
first step was to estimate the number of clinicians to submit as an 
individual clinician or group via each mechanism during the 2017 MIPS 
performance period using 2016 PQRS data on individuals and groups 
submitting through various mechanisms and excluding clinicians 
identified as QPs using the initial QP determination file as described 
in the 2017 Quality Payment Program final rule (81 FR 77444).
    Based on these methods, Table 54 shows that in the 2018 MIPS 
performance period, an estimated 278,039 clinicians will submit as 
individuals via claims submission mechanisms; 255,228 clinicians will 
submit as individuals, or as part of groups or virtual groups via 
qualified registry or QCDR submission mechanisms; 131,133 clinicians 
will submit as individuals, or as part of groups or virtual groups via 
EHR submission mechanisms; and 93,867 clinicians will submit as part of 
groups via the CMS Web Interface.
    Although we did not finalize multiple submission mechanisms within 
a performance category for the 2018 MIPS performance period, we are 
capturing the burden of any eligible clinician that may have 
historically submitted via multiple mechanisms, as we assume they would 
continue to submit via multiple mechanisms and that our MIPS scoring 
methodology would take the highest score. Hence, the estimated numbers 
of individual clinicians, groups, and virtual groups to submit via the 
various submission mechanisms are not mutually exclusive, and reflect 
the occurrence of individual clinicians or groups that submitted data 
via multiple mechanism under the 2016 PQRS.

       Table 54--Estimated Number of Clinicians Submitting Quality Performance Category Data by Mechanism
----------------------------------------------------------------------------------------------------------------
                                                                                                     CMS Web
                                                   Claims       QCDR/registry         EHR           interface
----------------------------------------------------------------------------------------------------------------
Estimated number of clinicians to submit via         278,039          255,228          131,133           93,867
 mechanism (as individual clinicians,
 groups, or virtual groups) in Quality
 Payment Program Year 1 (excludes QPs)......
----------------------------------------------------------------------------------------------------------------

    Table 54 provides estimates of the number of clinicians to submit 
quality measures via each mechanism, regardless of whether they decide 
to submit as individual clinicians or as part of groups or virtual 
groups. Because our burden estimates for quality data submission assume 
that burden is reduced when clinicians elect to submit as part of a 
group or virtual group, we also separately estimate the expected number 
of clinicians to submit as individuals or part of groups or virtual 
groups.
    Table 55 uses methods similar to those described for Table 54 to 
estimate the number of clinicians to submit as individual clinicians 
via each mechanism in Quality Payment Program Year 2. We estimate that 
approximately 278,039 clinicians will submit as individuals via claims 
submission mechanisms; approximately 104,281 clinicians will submit as 
individuals via qualified registry or QCDR submission mechanisms; and 
approximately 52,709 clinicians will submit as individuals via EHR 
submission mechanisms. Individual clinicians cannot elect to submit via 
CMS Web Interface. Consistent with the policy finalized in section 
II.C.7.a. of this final rule with comment period to score individual 
clinicians on quality measures independently for each submission 
mechanism submitted via multiple mechanisms, our columns in Table 55 
are not mutually exclusive.

[[Page 53910]]



      Table 55--Estimated Number of Clinicians Submitting Quality Performance Category Data as Individuals
----------------------------------------------------------------------------------------------------------------
                                                                                                     CMS Web
                                                   Claims       QCDR/registry         EHR           interface
----------------------------------------------------------------------------------------------------------------
Estimated number of Clinicians to submit             278,039          104,281           52,709                0
 data as individuals in Quality Payment
 Program Year 1 (excludes QPs) (a)..........
----------------------------------------------------------------------------------------------------------------

    Table 56 provides our estimated counts of groups or virtual groups 
to submit quality data on behalf of clinicians via each mechanism in 
the 2018 MIPS performance period and reflects our assumption that the 
formation of virtual groups will reduce burden. Except for groups 
comprised entirely of QPs, we assume that groups that submitted quality 
data as groups under the 2016 PQRS will continue to submit quality data 
either as groups or virtual groups via the same submission mechanisms 
as they did as a group or TIN within a virtual group for the 2018 MIPS 
performance period. The first step in estimating the numbers of groups 
or virtual groups to submit via each mechanism in the 2018 MIPS 
performance period was to estimate the number of groups to submit on 
behalf of clinicians via each mechanism in the 2017 MIPS performance 
period. We used 2016 PQRS data on groups submitting on behalf of 
clinicians via various mechanisms and excluded groups comprised 
entirely of QPs using the initial QP determination file as described in 
the 2017 Quality Payment Program final rule (81 FR 77444). The second 
and third steps in Table 56 reflect our assumption that virtual groups 
will reduce the burden for quality data submission by reducing the 
number of organizations to submit quality data on behalf of clinicians. 
We assume that 40 groups that previously submitted on behalf of 
clinicians via QCDR or qualified registry submission mechanisms will 
elect to form 8 virtual groups that will submit via QCDR and qualified 
registry submission mechanisms. We assume that another 40 groups that 
previously submitted on behalf of clinicians via EHR submission 
mechanisms will elect to form another 8 virtual groups via EHR 
submission mechanisms. Hence, the third step in Table 56 is to subtract 
out the estimated number of groups under each submission mechanism that 
will elect to form virtual groups, and the fourth step in Table 56 is 
to add in the estimated number of virtual groups that will submit on 
behalf of clinicians via each submission mechanism.
    Specifically, we assumed that 2,936 groups and virtual groups will 
submit data via QCDR/registry submission mechanisms on behalf of 
150,957 clinicians; 1,509 groups and virtual groups will submit via EHR 
submission mechanisms on behalf of 78,424 eligible clinicians; and 296 
groups will submit data via the CMS Web Interface on behalf of 93,867 
clinicians. Groups cannot elect to submit via claims submission 
mechanism.

     Table 56--Estimated Number of Groups and Virtual Groups Submitting Quality Performance Category Data by
                                        Mechanism on Behalf of Clinicians
----------------------------------------------------------------------------------------------------------------
                                                                                                      CMS Web
                                                      Claims       QCDR/registry        EHR          interface
----------------------------------------------------------------------------------------------------------------
Estimated number of groups to submit via                       0           2,968           1,541             296
 mechanism (on behalf of clinicians) in Quality
 Payment Program Year 1 (excludes QPs) (a)......
Subtract out: Estimated number groups to submit                0              40              40               0
 via mechanism on behalf of clinicians in
 Quality Payment Program Year 1 that will submit
 as virtual groups in Quality Payment Program
 Year 2 (b).....................................
Add in: Estimated number of virtual groups to                  0               8               8               0
 submit via mechanism on behalf of clinicians in
 Quality Payment Program Year 2 (c).............
Estimated number groups to submit via mechanism                0           2,936           1,509             296
 on behalf of clinicians in Quality Payment
 Program Year 2 (d) = (a)-(b) + (c).............
----------------------------------------------------------------------------------------------------------------

    These burden estimates have some limitations. We believe it is 
difficult to quantify the burden accurately because clinicians and 
groups may have different processes for integrating quality data 
submission into their practices' work flows. Moreover, the time needed 
for a clinician to review quality measures and other information, 
select measures applicable to their patients and the services they 
furnish, and incorporate the use of quality data codes into the 
practice workflows is expected to vary along with the number of 
measures that are potentially applicable to a given clinician's 
practice. Further, these burden estimates are based on historical rates 
of participation in the PQRS program, and the rate of participation in 
MIPS are expected to differ.
    We believe the burden associated with submitting the quality 
measures will vary depending on the submission method selected by the 
clinician, group, or virtual group. As such, we break down the burden 
estimates by clinicians, groups, and virtual groups by the submission 
method used.
    We anticipate that clinicians and groups using QCDR, qualified 
registry, and EHR submission mechanisms will have the same start-up 
costs related to reviewing measure specifications. As such, we estimate 
for clinicians, groups, and virtual groups using any of these three 
submission mechanisms a total of 6 staff hours needed to review the 
quality measures list, review the various submission options, select 
the most appropriate submission option, identify the applicable 
measures or specialty measure sets for which they can report the 
necessary information, review the measure specifications for the 
selected measures or measures group, and incorporate submission of the 
selected measures or specialty measure sets into the practice work 
flows. Building on data in a recent article, Casalino et al. (2016), we 
assume that a range of expertise is needed to review quality measure 
specifications: 2 hours of a practice administrator's time, 1 hour of a 
clinician's time, 1 hour of an LPN/medical assistant's time, 1 hour of 
a computer systems analyst's time, and 1

[[Page 53911]]

hour of a billing clerk's time.\41\ In the CY 2017 Quality Payment 
Program final rule we estimated 3 hours for a practice administrator's 
time for data submission. Because the new CMS API will be available for 
EHR, registry and QCDR, and CMS Web Interface submission mechanisms, we 
have reduced our estimate to 2 hours of a practice administrator's time 
for data submission for EHR and 2 hours using registry or QCDR. This 
CMS API will streamline the process of reviewing measure specifications 
and submitting measures for third-party submission mechanisms. We have 
also reduced our burden estimate for CMS Web Interface to reflect the 
new CMS API in a separate section below.\42\
---------------------------------------------------------------------------

    \41\ Our burden estimates are based on prorated versions of the 
estimates for reviewing measure specifications in Lawrence P. 
Casalino et al., ``US Physician Practices Spend More than $15.4 
Billion Annually to Report Quality Measures,'' Health Affairs, 35, 
no. 3 (2016): 401-406. The estimates were annualized to 50 weeks per 
year, and then prorated to reflect that Medicare revenue is 30 
percent of all revenue paid by insurers, and then adjusted to 
reflect that the decrease from 9 required quality measures under 
PQRS to 6 required measures under MIPS.
    \42\ CMS: New API Will Automate MACRA Quality Measure Data 
Sharing. http://healthitanalytics.com/news/cms-new-api-will-automate-macra-quality-measure-data-sharing.
---------------------------------------------------------------------------

    For the claims submission mechanism, we estimate that the start-up 
cost for a MIPS eligible clinician's practice to review measure 
specifications is $684.90, including 3 hours of a practice 
administrator's time (3 hours x $105.16=$315.48), 1 hour of a computer 
systems analyst time (1 hour x $88.10/hou r= $88.10), 1 hour of an LPN/
medical assistant's time (1 hour x $43.12), 1 hour of a billing clerk's 
time (1 hour x $36.12/hour = $36.12) and 1 hour of a clinician's time 
(1 hour x $202.08/hour = $202.08). These start-up costs pertain to the 
specific quality submission methods below, and hence appear in the 
burden estimate tables.
    For the purposes of our burden estimates for the claims, qualified 
registry and QCDR, and EHR submission mechanisms, we also assume that, 
on average, each clinician, group, or virtual group will submit 6 
quality measures.
    Our estimated number of respondents for the QCDR/qualified registry 
and EHR submission mechanisms increased relative to the estimates in 
the CY 2017 Quality Payment Program final rule. Our estimated 
respondents for the claims submission mechanism has declined relative 
to the CY 2017 Quality Payment Program final rule in part because we 
have excluded QPs from our burden estimates; in the CY 2017 Quality 
Payment Program final rule, QPs were included in our burden estimates 
due to data limitations. The number of respondents for CMS Web 
Interface has declined relative to the estimates in the CY 2017 Quality 
Payment Program final rule because our estimates now exclude QPs and 
CMS Web Interface data submitted in 2016 by Shared Savings Program and 
Next Generation and Pioneer ACOs to fulfill the requirement of their 
models. As noted in this section of the CY 2018 Quality Payment Program 
final rule with comment period, information collections associated with 
the Shared Savings Program and the testing, evaluation, and expansion 
of CMS Innovation Center models are not subject to the PRA.
    The following is a summary of the public comments received 
regarding our request for information on our general burden estimates 
regarding the quality performance category.
    Comment: One commenter believed that the quality performance 
category costs were grossly underestimated because CMS assumes that all 
practices have a practice manager, IT support, LPN, and billing clerk 
to assist clinicians in carrying out reporting requirements; however, 
the commenter noted that, for many small practices, this work is done 
by the clinicians themselves, at a higher cost than CMS estimates.
    Response: We acknowledge commenter's concerns regarding burden 
estimates for the quality performance category for small practices. We 
clarify, however, that time spent incorporating measures into practice 
workflow is not part of our time estimates given that time associated 
with day-to-day clinician practice is not included in the Collection of 
Information section, under the PRA, and therefore, not included in our 
burden estimates. Further, while our time estimates rely on 
assumptions, including a list of possible staff who may assist 
clinicians in carrying out reporting requirements, we highlight that 
these assumptions are focused on the staff for an average practice. 
However, we believe that are estimates are applicable to all practices 
because these estimates are grounded in reliable data sources, and past 
program methodologies including that of PQRS, and our analysis and 
justifications are detailed in this section of the final rule with 
comment period.
    Comment: One commenter expressed concern about the lack of clinical 
relevance to patient care in the Quality Payment Program and time to 
spent reporting on quality measures, citing a 2016 Health Affairs study 
that CMS cited in the CY 2018 Quality Payment Program proposed rule (82 
FR 30219), which found that practices in 4 common specialties spend, on 
average, 785 hours per physician and more than $15.4 billion on quality 
measure reporting programs that nearly three-quarters of practices 
stated were not clinically relevant.
    Response: In general, we believe that the changes in this final 
rule with comment period will improve the quality and value of care 
provided to Medicare beneficiaries. We have provided clinicians the 
flexibility to identify and select quality measures that are clinically 
relevant for their patients and practice. As a result, we expect that, 
over time, clinician engagement in the Quality Payment Program may 
result in improved quality of patient care, resulting in lower 
morbidity and mortality. We appreciate clinician concerns with 
reporting burden and have tried to reduce burden where possible while 
meeting the intent of the Act, including our obligations to improve 
patient outcomes. In future program years, we anticipate that the 
burden will be reduced as MIPS eligible clinicians become more familiar 
with the quality measures and submission requirements.
    Our estimated data submission burden for the Quality Payment 
Program, approximately $695 million, is significantly lower than the 
estimated $15.4 billion cost of quality reporting programs described in 
the Casalino et al. (2016). Our burden estimates are based on prorated 
versions of the estimates for reviewing measure specifications in 
Casalino et al., ``US Physician Practices Spend More than $15.4 Billion 
Annually to Report Quality Measures,'' Health Affairs, 35, no. 3 
(2016): 401-406. The estimates were annualized to 50 weeks per year, 
and then prorated to reflect that Medicare revenue is 30 percent of all 
revenue paid by insurers, and then adjusted to reflect that the 
decrease from 9 required quality measures under PQRS to 6 required 
measures under MIPS. We also refer to the CY 2017 Quality Payment 
Program final rule (81 FR 77502), where we provided a footnote that 
describes the prorated assumptions which are also included in this 
final rule with comment period burden estimates.
    After consideration of public comments, no changes were made to the 
quality performance category burden estimate in response to comments 
specific to that performance category. The burden estimates were 
updated from the CY 2018 Quality Payment Program proposed rule (82 FR 
30218 to 30219) to reflect updated data sources on the number of 
respondents, and to reflect that we are not finalizing the policy to 
allow facility-based

[[Page 53912]]

measurement until the 2019 MIPS performance period.
1. Burden for Quality Data Submission by Clinicians: Claims-Based 
Submission
    As noted in Table 54, based on 2016 PQRS data and 2017 MIPS 
eligibility data, we assume that 278,039 individual clinicians will 
submit quality data via claims. We anticipate the claims submission 
process for MIPS will be operationally similar to the way the claims 
submission process functioned under the PQRS. Specifically, clinicians 
will need to gather the required information, select the appropriate 
quality data codes (QDCs), and include the appropriate QDCs on the 
claims they submit for payment. Clinicians will collect QDCs as 
additional (optional) line items on the CMS-1500 claim form or the 
electronic equivalent HIPAA transaction 837-P, approved by OMB under 
control number 0938-1197.
    The total estimated burden of claims-based submission will vary 
along with the volume of claims on which the submission is based. Based 
on our experience with the PQRS, we estimate that the burden for 
submission of quality data will range from 0.22 hours to 10.8 hours per 
clinician. The wide range of estimates for the time required for a 
clinician to submit quality measures via claims reflects the wide 
variation in complexity of submission across different clinician 
quality measures. As shown in Table 57, we also estimate that the cost 
of quality data submission using claims will range from $19.38 (0.22 
hours x $88.10) to $951.48 (10.8 hours x $88.10). The total estimated 
annual cost per clinician ranges from the minimum burden estimate of 
$704.28 to a maximum burden estimate of $1,636.38. The burden will 
involve becoming familiar with MIPS data submission requirements. As 
noted in Table 57, we believe that the start-up cost for a clinician's 
practice to review measure specifications totals 7 hours, which 
includes 3 hours of a practice administrator's time (3 hours x $105.16 
= $315.48), 1 hour of a clinician's time (1 hour x $202.08/hour = 
$202.08), 1 hour of an LPN/medical assistant's time (1 hour x $43.12 = 
$43.12), 1 hour of a computer systems analyst's time (1 hour x $88.10 = 
$88.10), and 1 hour of a billing clerk's time (1 hour x $36.12/hour = 
$36.12).
    Considering both data submission and start-up costs, the total 
estimated burden hours per clinician ranges from a minimum of 7.22 
hours (0.22 + 3 + 1 + 1 + 1 + 1) to a maximum of 17.8 hours (10.8 + 3 + 
1 + 1 + 1 + 1). The total estimated annual cost per clinician ranges 
from the minimum estimate of $704.28 ($19.38 + $315.48 + $88.10 + 
$43.12 + $36.12 + $202.08) to a maximum estimate of $1,636.38 ($951.48 
+ $315.48 + $88.10 + $43.12 + $36.12 + $202.08). Therefore, total 
annual burden cost is estimated to range from a minimum burden estimate 
of $195,817,307 (278,039 x $704.28) to a maximum burden estimate of 
$454,977,459 (278,039 x $1,636.38).
    Based on the assumptions discussed in this section of this final 
rule with comment period, Table 57 summarizes the range of total annual 
burden associated with clinicians using the claims submission 
mechanism.

  Table 57--Burden Estimate for Quality Performance Category: Clinicians Using the Claims Submission Mechanism
----------------------------------------------------------------------------------------------------------------
                                                                                                  Maximum burden
                                                                  Minimum burden   Median burden     estimate
----------------------------------------------------------------------------------------------------------------
Estimated # of Clinicians (a)...................................         278,039         278,039         278,039
Burden Hours per Clinician to Submit Quality Data (b)...........            0.22            1.58            10.8
Estimated # of Hours Practice Administrator Review Measure                     3               3               3
 Specifications (c).............................................
Estimated # of Hours Computer Systems Analyst Review Measure                   1               1               1
 Specifications (d).............................................
Estimated # of Hours LPN Review Measure Specifications (e)......               1               1               1
Estimated # of Hours Billing Clerk Review Measure Specifications               1               1               1
 (f)............................................................
Estimated # of Hours Clinician Review Measure Specifications (g)               1               1               1
Estimated Annual Burden hours per Clinician (h) = (b) + (c) +               7.22            8.58            17.8
 (d) + (e) + (f) + (g)..........................................
Estimated Total Annual Burden Hours (i) = (a) * (h).............       2,007,442       2,385,575       4,949,094
Estimated Cost to Submit Quality Data (@computer systems                  $19.38         $139.20         $951.48
 analyst's labor rate of $88.10/hr.) (j)........................
Estimated Cost to Review Measure Specifications (@practice               $315.48         $315.48         $315.48
 administrator's labor rate of $105.16/hr.) (k).................
Estimated Cost to Review Measure Specifications (@computer                $88.10          $88.10           88.10
 systems analyst's labor rate of $88.10/hr.) (l)................
Estimated Cost to Review Measure Specifications (@LPN's labor             $43.12          $43.12          $43.12
 rate of $43.12/hr.) (m)........................................
Estimated Cost to Review Measure Specifications (@billing                 $36.12          $36.12          $36.12
 clerk's labor rate of $36.12/hr.) (n)..........................
Estimated Cost to Review Measure Specifications (@physician's            $202.08         $202.08         $202.08
 labor rate of $202.08/hr.) (o).................................
Estimated Total Annual Cost per Clinician (p) = (j) + (k) + (l)          $704.28         $824.10       $1,636.38
 + (m) + (n) + (o)..............................................
Estimated Total Annual Burden Cost (q) = (a) * (p)..............    $195,817,307    $229,131,940    $454,977,459
----------------------------------------------------------------------------------------------------------------

    We received no public comment specific to our burden estimates for 
the quality performance category claims submission mechanism. The 
burden estimates were updated from the CY 2018 Quality Payment Program 
proposed rule to reflect updated data sources on the number of 
respondents, and to reflect that we are not finalizing the policy to 
allow facility-based measurement until the 2019 MIPS performance 
period.
2. Burden for Quality Data Submission by Individuals, Groups, and 
Virtual Groups Using Qualified Registry and QCDR Submissions
    As noted in Table 54 and based on the 2016 PQRS data and 2017 MIPS 
eligibility data, we assume that 255,228 clinicians will submit quality 
data as individuals, groups, or virtual groups via qualified registry 
or QCDR submissions. Of these, we expect 104,281 clinicians, as shown 
in Table 55, to submit as individuals and 2,936 groups, as shown in 
Table 56, are expected to submit on behalf of the remaining 150,947 
clinicians. Given that the number of measures required is the

[[Page 53913]]

same for clinicians, groups, and virtual groups, we expect the burden 
to be the same for each respondent submitting data via qualified 
registry or QCDR, whether the clinician is participating in MIPS as an 
individual, group or virtual group.
    We estimate that burdens associated with QCDR submissions are 
similar to the burdens associated with qualified registry submissions. 
Therefore, we discuss the burden for both data submissions together 
below. For qualified registry and QCDR submissions, we estimate an 
additional time burden for respondents (individual clinicians, groups, 
and virtual groups) to become familiar with MIPS submission 
requirements and, in some cases, specialty measure sets and QCDR 
measures. Therefore, we believe that the costs for an individual 
clinician or group to review measure specifications and submit quality 
data total $843.74. For review costs and data submission costs, this 
total includes 3 hours per respondent to submit quality data (3 hours x 
$88.10/hour = $264.00), 2 hours of a practice administrator's time (2 
hours x $105.16/hour = $210.32), 1 hour of a computer systems analyst's 
time (1 hour x $88.10/hour = $88.10), 1 hour of an LPN/medical 
assistant's time, (1 hour x $43.12/hour = $43.12), 1 hour of a billing 
clerk's time (1 hour x $36.12/hour = $36.12) and 1 hour of a 
clinician's time (1 hour x $202.08). Clinicians, groups, and virtual 
groups will need to authorize or instruct the qualified registry or 
QCDR to submit quality measures' results and numerator and denominator 
data on quality measures to us on their behalf. We estimate that the 
time and effort associated with authorizing or instructing the quality 
registry or QCDR to submit this data will be approximately 5 minutes 
(0.083 hours) per clinician or group (respondent) for a total burden 
cost of $7.31, at a computer systems analyst's labor rate (.083 hours x 
$88.10/hour). Hence, we estimate 9.083 burden hours per respondent, 
with annual total burden hours of 973,852 (9.083 burden hours x 107,217 
respondents). The total estimated annual cost per respondent is 
estimated to be approximately $851.05. Therefore, total annual burden 
cost is estimated to be $91,247,028 (107,217 x $851.05). Based on these 
assumptions, we have estimated in Table 58 the burden for these 
submissions.

 Table 58--Burden Estimate for Quality Performance Category: Clinicians
   (Participating Individually or as Part of a Group or Virtual Group)
              Using the Qualified Registry/QCDR Submission
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of clinicians submitting as individuals (a)...........         104,281
# of groups or virtual groups submitting via QCDR or               2,936
 registry on behalf of individual clinicians (b)........
# of Respondents (groups and virtual groups plus                 107,217
 clinicians submitting as individuals) (c) = (a) + (b)..
Estimated Burden Hours per Respondent to Report Quality                3
 Data (d)...............................................
Estimated # of Hours Practice Administrator Review                     2
 Measure Specifications (e).............................
Estimated # of Hours Computer Systems Analyst Review                   1
 Measure Specifications (f).............................
Estimated # of Hours LPN Review Measure Specifications                 1
 (g)....................................................
Estimated # of Hours Billing Clerk Review Measure                      1
 Specifications (h).....................................
Estimated # of Hours Clinician Review Measure                          1
 Specifications (i).....................................
Estimated # of Hours Per Respondent to Authorize                   0.083
 Qualified Registry to Report on Respondent's Behalf (j)
Estimated Annual Burden Hours Per Respondent (k) = (d) +           9.083
 (e) + (f) + (g) + (h) + (i) + (j)......................
Estimated Total Annual Burden Hours (l) = (c) * (k).....         973,852
Estimated Cost per Respondent to Submit Quality Data             $264.00
 (@computer systems analyst's labor rate of $88.10/hr.)
 (m)....................................................
Estimated Cost to Review Measure Specifications                  $210.32
 (@practice administrator's labor rate of $105.16/hr.)
 (n)....................................................
Estimated Cost Computer System's Analyst Review Measure           $88.10
 Specifications (@computer systems analyst's labor rate
 of $88.10/hr.) (o).....................................
Estimated Cost LPN Review Measure Specifications (@LPN's          $43.12
 labor rate of $43.12/hr.) (p)..........................
Estimated Cost Billing Clerk Review Measure                       $36.12
 Specifications (@clerk's labor rate of $36.12/hr.) (q).
Estimated Cost Clinician Review Measure Specifications           $202.08
 (@physician's labor rate of $202.08/hr.) (r)...........
Estimated Burden for Submission Tool Registration etc.             $7.31
 (@computer systems analyst's labor rate of $88.1/hr.)
 (s)....................................................
Estimated Total Annual Cost Per Respondent (t) = (m) +           $851.05
 (n) + (o) + (p) + (q) + (r) + (s)......................
Estimated Total Annual Burden Cost (u) = (c) * (t)......     $91,247,028
------------------------------------------------------------------------

    The following is a summary of the public comments received 
regarding our request for information on our qualified registry/QCDR 
burden estimates regarding the quality performance category.
    Comment: One commenter believed that the quality performance 
category costs were grossly underestimated because CMS does not 
consider the direct cost of qualified registry/QCDR submission, which 
can be substantial, nor does CMS include the direct, often 
considerable, cost of data mapping and maintaining the interface with 
qualified registry/QCDR.
    Response: We are unable to estimate the potential costs of fees 
paid to QCDRs and registries because this information will vary by QCDR 
or registry and we do not know which MIPS eligible clinician will use 
which QCDR or registry.
    The burden estimates in this section address time costs, not direct 
financial costs for data submission to registries and QCDRs. The CY 
2017 Quality Payment Program final rule established a policy to have 
QCDRs and registries publish fees (81 FR 77505). The fees are published 
at https://qpp.cms.gov/docs/QPP_2017_Qualified_Registries.pdf.
    Comment: One commenter expressed concern that multiple submission 
options may increase the likelihood of successful participation in MIPS 
but that it also drives up the costs of participation incurred by 
clinicians. In order to have a sufficient number of measures to report 
and file with CMS, clinicians will incur fees to a QCDR or registry 
(possibly several) followed by paying their staff or outside vendors 
and consultants to assemble, test, and submit their information. This 
may prove to be impractical financially for some clinicians. The 
commenter suggested that QCDR and registry vendors should explore 
innovative pricing options that help make MIPS participation more 
affordable.
    Response: We acknowledge the commenter's concerns with QCDR and 
registry fees in order to have sufficient number of measures to report 
and file with CMS given the proposed multiple

[[Page 53914]]

submissions options policy. As mentioned in II.C.6.a.(1) of the final 
rule with comment period, we are finalizing the multiple submission 
mechanism policy beginning with the 2019 MIPS performance period to 
allow additional time to communicate how this policy intersects with 
our measure applicability policies.
    Our burden estimates for clinicians submitting through multiple or 
single submission mechanism reflect the time costs, but not the direct 
financial costs of data submission. In the CY 2017 Quality Payment 
Program final rule (81 FR 77505) we finalized a policy to post QCDR's 
self-reported costs for MIPS eligible clinicians or groups to use the 
QCDR on the CMS Web site alongside their organizational contact 
information and the services and measures offered. In summary, no 
changes were made to the quality performance category qualified 
registry/QCDR burden estimate in response to comments received. The 
burden estimates were updated from the CY 2018 Quality Payment Program 
proposed rule to reflect updated data sources on the number of 
respondents, and to reflect that we are not finalizing the policy to 
allow facility-based measurement until the 2019 MIPS performance 
period.
    After consideration of public comments, we made no changes to our 
qualified registry/QCDR burden estimates. The burden estimates were 
updated from the CY 2018 Quality Payment Program proposed rule (82 FR 
30222) to reflect updated data sources on the number of respondents, 
and to reflect that we are not finalizing the policy to allow facility-
based measurement until the 2019 MIPS performance period.
3. Burden for Quality Data Submission by Clinicians, Groups, and 
Virtual Groups: EHR Submission
    As noted in Tables 54, 55 and 56, based on 2016 PQRS data and 2017 
MIPS eligibility data, we assume that 131,133 clinicians will submit 
quality data as individuals or groups via EHR submissions; 52,709 
clinicians are expected to submit as individuals; and 1,509 groups are 
expected to submit on behalf of 78,424 clinicians. We expect the burden 
to be the same for each respondent submitting data via EHR, whether the 
clinician is participating in MIPS as an individual or group.
    Under the EHR submission mechanism, the individual clinician or 
group may either submit the quality measures data directly to us from 
their EHR or utilize an EHR data submission vendor to submit the data 
to us on the clinician's or group's behalf.
    To prepare for the EHR submission mechanism, the clinician or group 
must review the quality measures on which we will be accepting MIPS 
data extracted from EHRs, select the appropriate quality measures, 
extract the necessary clinical data from their EHR, and submit the 
necessary data to the CMS-designated clinical data warehouse or use a 
health IT vendor to submit the data on behalf of the clinician or 
group. We assume the burden for submission of quality measures data via 
EHR is similar for clinicians, groups, and virtual groups who submit 
their data directly to us from their CEHRT and clinicians, groups, and 
virtual groups who use an EHR data submission vendor to submit the data 
on their behalf. To submit data to us directly from their CEHRT, 
clinicians, groups, and virtual groups must have access to a CMS-
specified identity management system which we believe takes less than 1 
hour to obtain. Once a clinician or group has an account for this CMS-
specified identity management system, they will need to extract the 
necessary clinical data from their EHR, and submit the necessary data 
to the CMS-designated clinical data warehouse.
    We estimate that obtaining an account on a CMS-specified identity 
management system will require 1 hour per respondent for a cost of 
$88.10 (1 hour x $88.10/hour). For submitting the actual data file, we 
believe that this will take clinicians or groups no more than 2 hours 
per respondent for a cost of submission of $176.20 (2 hours x $88.10/
hour). The burden will involve becoming familiar with MIPS submission. 
We believe that the start-up cost for a clinician or group to review 
measure specifications is a total of 6 hours which includes 2 hours of 
a practice administrator's time (2 hours x $105.16/hour = $210.32), 1 
hour of a clinician's time (1 hour x $202.08/hour = $202.08), 1 hour of 
a computer systems analyst's time (1 hour x $88.10/hour = $88.10), 1 
hour of an LPN/medical assistant's time (1 hour x $43.12/hour = 
$43.12), and 1 hour of a billing clerk's time (1 hour x $36.12/hour = 
$36.12). Hence, we estimated 9 total burden hours per respondent with 
annual total burden hours of 487,962 (9 burden hours x 54,218 
respondents). The total estimated annual cost per respondent is 
estimated to be $844.04. Therefore, total annual burden cost is 
estimated to be $45,762,161 = (54,218 respondents x $844.04).
    Based on the assumptions discussed in section II.C.6.a of this 
final rule with comment period, we have estimated the burden for the 
quality data submission using EHR submission mechanism in Table 59.

 Table 59--Burden Estimate for Quality Performance Category: Clinicians
 (Submitting Individually or as Part of a Group or Virtual Group) Using
                      the EHR Submission Mechanism
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of clinicians submitting as individuals (a)...........          52,709
# of Groups and virtual groups submitting via EHR on               1,509
 behalf of individual clinicians (b)....................
# of Respondents (groups and virtual groups plus                  54,218
 clinicians submitting as individuals) (c) = (a) + (b)..
Estimated Burden Hours Per Respondent to Obtain Account                1
 in CMS-Specified Identity Management System (d)........
Estimated Burden Hours Per Respondent to Submit MIPS                   2
 Quality Data File to CMS (e)...........................
Estimated # of Hours Practice Administrator Review                     2
 Measure Specifications (f).............................
Estimated # of Hours Computer Systems Analyst Review                   1
 Measure Specifications (g).............................
Estimated # of Hours LPN Review Measure Specifications                 1
 (h)....................................................
Estimated # of Hours Billing Clerk Review Measure                      1
 Specifications (i).....................................
Estimated # of Hours Clinicians Review Measure                         1
 Specifications (j).....................................
Estimated Annual Burden Hours Per Respondent (k) = (d) +               9
 (e) + (f) + (g) + (h) + (i) + (j)......................
Estimated Total Annual Burden Hours (l) = (c) * (k).....         487,962
Estimated Cost Per Respondent to Obtain Account in CMS-           $88.10
 specified identity management system (@computer systems
 analyst's labor rate of $88.10/hr.) (m)................
Estimated Cost Per Respondent to Submit Quality Data             $176.20
 (@computer systems analyst's labor rate of $88.10/hr.)
 (n)....................................................
Estimated Cost to Review Measure Specifications                  $210.32
 (@practice administrator's labor rate of $105.16/hr.)
 (o)....................................................

[[Page 53915]]

 
Estimated Cost to Review Measure Specifications                   $88.10
 (@computer systems analyst's labor rate of $88.10/hr.)
 (p)....................................................
Estimated Cost to Review Measure Specifications (@LPN's           $43.12
 labor rate of $43.12/hr.) (q)..........................
Estimated Cost to Review Measure Specifications                   $36.12
 (@clerk's labor rate of $36.12/hr.) (r)................
Estimated Cost to D21Review Measure Specifications               $202.08
 (@physician's labor rate of $202.08/hr.) (s)...........
Estimated Total Annual Cost Per Respondent (t) = (m) +           $844.04
 (n) + (o) + (p) + (q) + (r) + (s)......................
Estimated Total Annual Burden Cost (u) = (c) * (t)......     $45,762,161
------------------------------------------------------------------------

    The following is a summary of the public comments received 
regarding our request for information on our EHR submission mechanism 
burden estimates regarding the quality performance category.
    Comment: One commenter did not support our quality performance 
category burden estimates because the commenter believed costs were 
grossly underestimated because CMS does not recognize time to train 
personnel in data capture, designing templates for data capture, 
documentation time, or time to review data submission reports and work 
with vendors to correct submissions. The commenter also noted that CMS 
also does not include IT consulting fees for small groups that lack 
internal IT departments and fails to consider direct fees from the EHR 
vendors submitting on behalf of clinicians (approximately $300/
physician).
    Response: We acknowledge commenter's concerns regarding our EHR 
submission mechanism burden estimates. We note that under the PRA, 
costs associated with training personnel is not included in the 
Collection of Information section, and, therefore, not included in our 
burden estimates. We note that costs and benefits are discussed in 
section VI.F. of this final rule with comment period. The burden 
estimates in this section address time costs, not direct financial 
costs.
    After consideration of public comments, we made no changes to the 
quality performance category EHR submission mechanism burden estimate. 
The burden estimates were updated from the CY 2018 Quality Payment 
Program proposed rule (82 FR 30222) to reflect updated data sources on 
the number of respondents, and to reflect that we are not finalizing 
the policy to allow facility-based measurement until the 2019 MIPS 
performance period.
4. Burden for Quality Data Submission via CMS Web Interface
    Based on 2016 PQRS data and as shown in Table 60, we assume that 
296 groups will submit quality data via the CMS Web Interface in the 
2018 MIPS performance period. We anticipate that approximately 93,867 
clinicians will be represented.
    The burden associated with the group submission requirements under 
the CMS Web Interface is the time and effort associated with submitting 
data on a sample of the organization's beneficiaries that is 
prepopulated in the CMS Web Interface. Based on experience with PQRS 
GPRO Web Interface submission mechanism, we estimate that, on average, 
it will take each group 74 hours of a computer systems analyst's time 
to submit quality measures data via the CMS Web Interface at a cost of 
$88.10 per hour, for a total cost of $6,519 (74 hours x $88.10/hour). 
Our estimate of 74 hours for submission includes the time needed for 
each group to populate data fields in the web interface with 
information on approximately 248 eligible assigned Medicare 
beneficiaries and then submit the data (we will partially pre-populate 
the CMS Web Interface with claims data from their Medicare Part A and B 
beneficiaries). The patient data either can be manually entered or 
uploaded into the CMS Web Interface via a standard file format, which 
can be populated by CEHRT. Because the CMS API will streamline the 
measure submission process for many groups, we have reduced our 
estimate of the computer system's analyst time needed for submission 
from 79 hours in the CY 2017 Quality Payment Program final rule to 74 
hours. Because each group must provide data on 248 eligible assigned 
Medicare beneficiaries (or all eligible assigned Medicare beneficiaries 
if the pool of eligible assigned beneficiaries is less than 248) for 
each measure, we assume that entering or uploading data for one 
Medicare beneficiary across all the measures requires approximately 18 
minutes of a computer systems analyst's time (74 hours / 248 patients 
for each measure).
    The total annual burden hours are estimated to be 21,904 (296 
groups x 74 annual hours), and the total annual burden cost is 
estimated to be $1,929,624 (296 groups x $6,519).
    Based on the assumptions discussed in this section of the CY 2018 
Quality Payment Program proposed rule, we have calculated in Table 60 
the following burden estimate for groups submitting to MIPS with the 
CMS Web Interface.

  Table 60--Burden Estimate for Quality Data Submission via the CMS Web
                                Interface
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Estimated # of Eligible Group Practices (a).............             296
Estimated Total Annual Burden Hours Per Group to Submit               74
 (b)....................................................
Estimated Total Annual Burden Hours (c) = (a) * (b).....          21,904
Estimated Cost Per Group to Report (@computer systems             $6,519
 analyst's labor rate of $88.10/hr.) (d)................
Estimated Total Annual Cost Per Group (e) = (d).........          $6,519
Estimated Total Annual Burden Cost (f) = (a) * (e)......      $1,929,624
                                                         ---------------
                                                            By Eligible
                                                           Clinician or
                                                               Group
Estimated # of Participating Eligible Professionals (g).         252,808

[[Page 53916]]

 
Average Burden Hours Per Eligible Professional (h) = (c)            0.09
 / (g)..................................................
Estimated Cost Per Eligible Professional to Report                 $7.63
 Quality Data (i) = (f) / (g)...........................
------------------------------------------------------------------------

    The following is a summary of the public comments received 
regarding our request for information on our Web Interface submission 
mechanism burden estimates regarding the quality performance category.
    Comment: One commenter believed that the quality performance 
category costs were grossly underestimated because the commenter 
believed that CMS incorrectly stated that each group reports on 248 
beneficiaries. The commenter noted that instead, they report on 248 
beneficiaries per measure x 15 measures. The commenter noted that while 
some patients may be represented in more than one measure, this is not 
the norm. Also, the commenter stated that CMS does not consider the 
time, in manual hours, needed to abstract data that is not readily 
available electronically, which the commenter noted can be a large 
cost. For the above reasons, the commenter shared concerns that the 
quality performance category costs were grossly underestimated.
    Response: Thank you for your comment on the CMS Web Interface 
submission mechanism burden estimates. Our estimate of 74 hours is an 
average across all groups that submit via the CMS Web Interface based 
on historical data available updated for the efficiencies of using API. 
Our estimate takes into consideration the 15 measures and 248 
beneficiaries selected for each measure. Users will have access to a 
redesigned CMS Web Interface and will no longer need to use an XML file 
to download and upload file. Instead users will be able to use an Excel 
template to upload and download files which we believe will help to 
streamline the data submission process.
    After consideration of public comments, we made no changes to the 
quality performance category Web Interface submission mechanism burden 
estimate. The burden estimates were updated from the CY 2018 Quality 
Payment Program proposed rule (82 FR 30223) to reflect updated data 
sources on the number of respondents.
5. Burden for Beneficiary Responses to CAHPS for MIPS Survey
    Under MIPS, groups of 2 or more clinicians can elect to contract 
with a CMS-approved survey vendor and use the CAHPS for MIPS survey as 
one of their 6 required quality measures. Beneficiaries that choose to 
respond to the CAHPS for MIPS survey will experience burden.
    The usual practice in estimating the burden on public respondents 
to surveys such as CAHPS is to assume that respondent time is valued, 
on average, at civilian wage rates. As previously explained, the BLS 
data show the average hourly wage for civilians in all occupations to 
be $23.86. Although most Medicare beneficiaries are retired, we believe 
that their time value is unlikely to depart significantly from prior 
earnings expense, and we have used the average hourly wage to compute 
the dollar cost estimate for these burden hours.
    Under the 2018 MIPS performance period, we assume that 461 groups 
will elect to report on the CAHPS for MIPS survey, which is equal to 
the number of groups reporting via CAHPS for the PQRS for reporting 
period 2016.\43\ Table 61 shows the estimated annualized burden for 
beneficiaries to participate in the CAHPS for MIPS Survey. Based on 
historical information on the numbers of CAHPS for PQRS survey 
respondents, we assume that an average of 287 beneficiaries will 
respond per group. Therefore, the CAHPS for MIPS survey will be 
administered to approximately 132,307 beneficiaries per year (461 
groups x an average of 287 beneficiaries per group responding).
---------------------------------------------------------------------------

    \43\ Because the CAHPS for PQRS survey was required for groups 
of 100 or more clinicians under the PQRS, we expect that group 
participation in CAHPS for MIPS survey, which is optional under 
MIPS, may be somewhat lower. Hence, we assume that the number of 
groups electing to use the CAHPS for MIPS survey will be equivalent 
to the second highest participation rate for CAHPS for PQRS survey, 
which occurred in year 2015 when 461 groups used the survey. The 
most popular year of the CAHPS for PQRS survey was reporting year 
2016, when 514 groups used the survey.
---------------------------------------------------------------------------

    In section II.C.6.b.(3)(1)(iii) of this final rule with comment 
period, we are establishing a policy to use a shorter version of the 
CAHPS for MIPS survey with 58 items, as compared to 81 items for the 
version that will be used in the transition year. The shorter survey is 
estimated to require an average administration time of 12.9 minutes (or 
0.22 hours) in English (at a pace of 4.5 items per minute). We assume 
the Spanish survey would require 15.5 minutes (assuming 20 percent more 
words in the Spanish translation). Because less than 1 percent of 
surveys were administered in Spanish for reporting year 2016, our 
burden estimate reflects the length of the English survey. Our 
finalized policy will reduce beneficiary burden compared to the 
transition year; we estimate that the 81-item survey requires an 
average administration time of 18 minutes in English and 21.6 minutes 
in Spanish. Compared to the survey for reporting year 2016, this is a 
reduction of 5.1 minutes (18 minutes to 12.9 minutes) in administration 
time for the English version and a reduction of 6.1 (21.6 minutes--15.5 
minutes) minutes in administration time for the Spanish version.
    Given that we expect approximately 132,307 respondents per year, 
the annual total burden hours are estimated to be 29,108 hours (132,307 
respondents x 0.22 burden hours per respondent). The estimated total 
burden annual burden cost is $694,612 (132,307 x $5.25).

  Table 61--Burden Estimate for Beneficiary Participation in CAHPS for
                               MIPS Survey
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Estimated # of Eligible Group Practices Administering                461
 CAHPS for Physician Quality Reporting Survey (a).......
Estimated # of Beneficiaries Per Group Responding to                 287
 Survey (b).............................................
Estimated # of Total Beneficiary Respondents (c) = (a) *         132,307
 (b)....................................................

[[Page 53917]]

 
Estimated # of Burden Hours Per Beneficiary Respondent              0.22
 (d)....................................................
Estimated Cost Per Beneficiary (@labor rate of $23.86/             $5.25
 hr.) (e)...............................................
Estimated Total Annual Burden Hours (f) = (c) * (d).....          29,108
Estimated Total Annual Burden Cost for Beneficiaries            $694,612
 Responding to CAHPS MIPS (g) = (c) * (e)...............
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
beneficiary participation in the CAHPS for MIPS survey. The burden 
estimates have not been changed from the CY 2018 Quality Payment 
Program proposed rule (82 FR 30224).
6. Burden for Group Registration for CMS Web Interface
    Groups interested in participating in MIPS using the CMS Web 
Interface for the first time must complete an on-line registration 
process. After first time registration, groups will only need to opt 
out if they are not going to continue to submit via the CMS Web 
Interface. In Table 62 we estimate that the registration process for 
groups under MIPS involves approximately 1 hour of administrative staff 
time per group. We assume that a billing clerk will be responsible for 
registering the group and that, therefore, this process has an average 
computer systems analyst labor cost of $88.10 per hour. Therefore, 
assuming the total burden hours per group associated with the group 
registration process is 1 hour, we estimate the total cost to a group 
associated with the group registration process to be approximately 
$88.10 ($88.10 per hour x 1 hour per group). We assume that 
approximately 10 groups will elect to use the CMS Web Interface 
submission mechanism in the 2018 MIPS performance period. The total 
annual burden hours are estimated to be 10 (10 groups x 1 annual hour), 
and the total annual burden cost is estimated to be $881.00 (10 groups 
x $88.10).

   Table 62--Total Estimated Burden for Group Registration for CMS Web
                                Interface
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Estimated Number of New Groups Registering for CMS Web                10
 Interface (a)..........................................
Estimated Annual Burden Hours Per Group (b).............               1
Estimated Total Annual Burden Hours (c) = (a) * (b).....              10
Estimated Cost per Group to Register for CMS Web                  $88.10
 Interface @computer systems analyst's labor rate of
 $88.10/hr.) (d)........................................
Estimated Total Annual Burden Cost for CMS Web Interface            $881
 Group Registration (e) = (a) * (d).....................
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
group registration for the CMS Web Interface. The burden estimates have 
not been updated from the CY 2018 Quality Payment Program proposed rule 
(82 FR 30224).
7. Burden for Group Registration for CAHPS for MIPS Survey
    Under MIPS, the CAHPS for MIPS survey counts for 1 measure towards 
the MIPS quality performance category and, as a patient experience 
measure, also fulfills the requirement to submit at least one high 
priority measure in the absence of an applicable outcome measure. 
Groups that wish to administer the CAHPS for MIPS survey must register 
by June of the applicable 12-month performance period, and 
electronically notify CMS of which vendor they have selected to 
administer the survey on their behalf. In the 2018 MIPS performance 
period, we assume that 461 groups will enroll in the MIPS for CAHPS 
survey.
    As shown in Table 63, we assume that the staff involved in the 
group registration for CAHPS for MIPS Survey will mainly be computer 
systems analysts or their equivalent, who have an average labor cost of 
$88.10/hour. We assume the CAHPS for MIPS Survey registration burden 
estimate includes the time to register for the survey as well as select 
the CAHPS for MIPS Survey vendor. Therefore, assuming the total burden 
hours per registration is 1 hour and 0.5 hours to select the CAHPS for 
MIPS Survey vendor that will be used and electronically notify CMS of 
their selection, the total burden hours for CAHPS for MIPS registration 
is 1.5. We estimate the total annual burden hours as 692 (461 groups x 
1.5 hours). We estimate the cost per group for CAHPS for MIPS Survey 
registration is $132.15 ($88.10 x 1.5 hours). We estimate that the 
total cost associated with the registration process is $60,921 ($132.15 
per hour x 461 hours per group).

   Table 63--Burden Estimate for Group Registration for CAHPS for MIPS
                                 Survey
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Estimated # of Groups Registering for CAHPS (a).........             461
Estimated Total Annual Burden Hours for CAHPS                        1.5
 Registration (b).......................................
Estimated Total Annual Burden Hours for CAHPS                        692
 Registration (c) = (a) * (b)...........................
Estimated Cost to Register for CAHPS@computer systems            $132.15
 analyst's labor rate of $88.10/hr.) (d)................
Estimated Total Annual Burden Cost for CAHPS                     $60,921
 Registration (e) = (a) * (d)...........................
------------------------------------------------------------------------


[[Page 53918]]

    The following is a summary of the public comments received 
regarding our estimated burden for the group registration for the CAHPS 
for MIPS survey.
    Comment: One commenter shared concerns regarding our assumptions 
for the burden estimates regarding CAHPS registration costs. The 
commenter stated that CMS does not consider direct costs of group 
contracting with a CAHPS vendor.
    Response: We are unable to estimate the cost of fees paid to CAHPS 
for MIPS survey vendors because this information is not available and 
we believe it may vary by vendor.
    Because the burden estimates in this section addresses time costs, 
not direct financial costs, no changes were made to the burden estimate 
for group registration for CAHPS for MIPS survey as a result of this 
comment.
    We received no public comments related to the burden estimates for 
group registration for the CAHPS for MIPS Survey. The burden estimates 
have not been updated from the CY 2018 Quality Payment Program proposed 
rule (82 FR 30225).

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

    During the 2018 MIPS performance period, clinicians, groups, and 
virtual groups can submit advancing care information data through 
qualified registry, QCDR, EHR, CMS Web Interface, and attestation data 
submission methods. We have worked to further align the advancing care 
information performance category with other MIPS performance 
categories. We anticipate that most organizations will use the same 
data submission mechanism for the advancing care information and 
quality performance categories and that the clinicians, practice 
managers, and computer systems analysts involved in supporting the 
quality data submission will also support the advancing care 
information data submission process. Hence, the burden estimate for the 
submission of advancing care information data below shows only 
incremental hours required above and beyond the time already accounted 
for in the quality data submission process. While this analysis 
assesses burden by performance category and submission mechanism, we 
emphasize that MIPS is a consolidated program and submission analysis 
and decisions are expected to be made for the program as a whole.
1. Burden for Advancing Care Information Application
    As stated in the CY 2017 Quality Payment Program final rule, some 
MIPS eligible clinicians may not have sufficient measures applicable 
and available to them for the advancing care information performance 
category, and as such, they may apply to have the advancing care 
information performance category re-weighted to zero in the following 
circumstances: insufficient internet connectivity, extreme and 
uncontrollable circumstances, lack of control over the availability of 
CEHRT (81 FR 77240 through 77243). As described in section II.C.6.f.(7) 
of this final rule with comment period, we are establishing a policy to 
allow MIPS eligible clinicians to apply to have their advancing care 
information performance category re-weighted to zero due to a 
significant hardship exception or exception for decertified EHR 
technology. We are also establishing a policy that MIPS eligible 
clinicians who are in small practices (15 or fewer clinicians) may, 
beginning with the 2018 MIPS performance period and 2020 MIPS payment 
year, request a reweighting to zero for the advancing care information 
performance category due to a significant hardship. We are finalizing 
our policy to rely on section 1848(o)(2)(D) of the Act, as amended by 
section 4002(b)(1)(B) of the 21st Century Cures Act, as our authority 
for the significant hardship exceptions.
    Table 64 shows the estimated annualized burden for clinicians to 
apply for a reweighting to zero of their advancing care information 
performance category due to a significant hardship exception or as a 
result of a decertification of an EHR, as well as an application for 
significant hardship by small practices. Based on 2016 data from the 
Medicare EHR Incentive Program and the first 2019 payment year MIPS 
eligibility and special status file, we assume 40,645 respondents 
(eligible clinicians, groups, or virtual groups) will submit a request 
for reweighting to zero of their advancing care information performance 
category due to a significant hardship exception, decertification of an 
EHR or significant hardship for small practices through the Quality 
Payment Program. We estimate that 5,812 respondents (eligible 
clinicians, groups, or virtual groups) will submit a request for a 
reweighting to zero for the advancing care information performance 
category due to extreme and uncontrollable circumstances or as a result 
of a decertification of an EHR, and 34,833 respondents will submit a 
request for a reweighting to zero for the advancing care information 
performance category as a small practice. The application to request a 
reweighting to zero for the advancing care information performance 
category due to significant hardship is a short online form that 
requires identifying which type of hardship or if decertification of an 
EHR applies and a description of how the circumstances impair the 
ability to submit the advancing care information data, as well as some 
proof of circumstances beyond the submitter's control. The estimate to 
submit this application is 0.5 hours of a computer system analyst's 
time. Given that we expect 40,645 applications per year, the annual 
total burden hours are estimated to be 20,323 hours (40,645 respondents 
x 0.5 burden hours per respondent). The estimated total annual burden 
is $1,790,412 (40,645 x $44.05).

Table 64--Burden Estimate for Application for Advancing Care Information
                          Hardship Applications
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Eligible Clinicians, Groups, or Virtual Groups                5,812
 Applying Due to Significant Hardship and Other
 Exceptions (a).........................................
# of Eligible Clinicians, Groups, or Virtual Groups               34,833
 Applying Due to Significant Hardship as Small Practice
 (b)....................................................
Total respondents Due to Hardships, Other Exceptions and          40,645
 Hardships for Small Practices (c)......................
Estimated Burden Hours Per Applicant for Advancing Care              0.5
 Information (d)........................................
Estimated Total Annual Burden Hours (e) = (a) * (c).....          20,323
Estimated Cost Per Applicant for Advancing Care                   $44.05
 Information (@computer systems analyst's labor rate of
 $88.10/hr.) (f)........................................
Estimated Total Annual Burden Cost (g) = (a) * (f)......      $1,790,412
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
application for reweighting for the advancing care information 
performance category. The burden estimates have not been updated from 
the CY 2018 Quality

[[Page 53919]]

Payment Program proposed rule (82 FR 30226).
2. Number of Organizations Submitting Advancing Care Information Data 
on Behalf of Eligible Clinicians
    A variety of organizations will submit advancing care information 
data on behalf of clinicians. Clinicians not participating in a MIPS 
APM can submit as individuals or as part of a group or virtual group. 
Group TINs may submit advancing care information data on behalf of 
clinicians in MIPS APMs, or, except for participants in the Shared 
Savings Program, clinicians in MIPS APMs may submit advancing care 
information performance category data individually. Because group TINs 
in APM Entities will be submitting advancing care information data to 
fulfill the requirements of submitting to MIPS, we have included MIPS 
APMs in our burden estimate for the advancing care information 
performance category. Consistent with the list of APMs that are MIPS 
APMs on the Quality Payment Program Web site,\44\ we assume that 3 MIPS 
APMs that do not also qualify as Advanced APMs will operate in the 2018 
MIPS performance period: Track 1 of the Shared Savings Program, CEC 
(one-sided risk arrangement), and the OCM (one-sided risk arrangement). 
Further, we assume that group TINs will submit advancing care 
information data on behalf of partial QPs that elect to participate in 
MIPS.
---------------------------------------------------------------------------

    \44\ https://qpp.cms.gov/docs/QPP_Advanced_APMs_in_2017.pdf.
---------------------------------------------------------------------------

    As shown in Table 65, based on data from the 2015 and 2016 Medicare 
and Medicaid EHR Incentive Programs, the 2016 PQRS data, and 2017 MIPS 
eligibility data, we estimate that 195,022 individual MIPS eligible 
clinicians and 668 groups or virtual groups, representing 101,873 MIPS 
eligible clinicians, will submit advancing care information data. These 
estimates reflect that under the policies finalized in CY 2017 Quality 
Payment Program final rule, certain MIPS eligible clinicians will be 
eligible for automatic reweighting of their advancing care information 
performance category score to zero, including MIPS eligible clinicians 
that practice primarily in the hospital, physician assistants, nurse 
practitioners, clinician nurse specialists, certified registered nurse 
anesthetists, and non-patient facing clinicians. These estimates also 
account for the significant hardships finalized in the CY 2017 Quality 
Payment Program final rule and the final policies adopted in this rule 
for significant hardship exceptions, including for MIPS eligible 
clinicians in small practices, as well as exceptions due to 
decertification of an EHR. Due to data limitations, our estimate of the 
number of clinicians to submit advancing care information data does not 
account for our policy finalized in this final rule with comment period 
to rely on section 1848(o)(2)(D) of the Act, as amended by section 
4002(b)(1)(B) of the 21st Century Cures Act, to assign a scoring weight 
of zero percent for the advancing care information performance category 
for MIPS eligible clinicians who are determined to be based in 
ambulatory surgical centers (ASCs) (section II.C.6.f.(7)(a) of this 
final rule with comment period).
    Further, we anticipate that the 480 Shared Savings Program ACOs 
will submit data at the ACO participant group TIN-level, for a total of 
15,945 group TINs. We anticipate that the three APM Entities electing 
the one-sided track in the CEC model will submit data at the group TIN-
level, for an estimated total of 100 group TINs submitting data. We 
anticipate that the 195 APM Entities in the OCM (one-sided risk 
arrangement) will submit data at APM Entity level, for an estimated 
total of 6,478 group TINs. Based on the initial QP determination file, 
we estimate 2 APM Entities in the CPC+ model will submit at the group 
TIN-level, for an estimated total of 2 group TINs submitting data. 
Based on the initial QP determination file, we assume that 1 CPC+ APM 
entity will submit data because one or more of its participants is a 
partial QP, and that 1 CPC+ APM Entity will submit data because some of 
its participants qualify as either as QPs or partial QPs. The total 
estimated number of respondents is estimated at 218,215.

   Table 65--Estimated Number of Respondents to Submit Advancing Care
          Information Performance Data on Behalf of Clinicians
------------------------------------------------------------------------
                                             Estimated       Estimated
                                             Number of     Number of APM
                                            respondents      entities
------------------------------------------------------------------------
Number of individual clinicians to               195,022  ..............
 submit advancing care information (a)..
Number of groups or virtual groups to                668  ..............
 submit advancing care information (b)..
Shared Savings Program ACO Group TINs             15,945             480
 (c)....................................
CEC one-sided risk track participants                100               3
 \45\ (d)...............................
OCM one-sided risk arrangement Group               6,478             195
 TINs (e)...............................
CPC+ TINs (f)...........................               2               2
Total (g) = (a) + (b) + (c) + (d) + (e)          218,215             680
 + (f)..................................
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
submitting advancing care information performance data. The burden 
estimates have not been updated from the CY 2018 Quality Payment 
Program proposed rule 82 FR 30227).
---------------------------------------------------------------------------

    \45\ The 3 CEC APM Entities reflected in the burden estimate are 
the non-large dialysis organizations participating in the one-sided 
risk track.
---------------------------------------------------------------------------

3. Burden for Submission of Advancing Care Information Data
    In Table 66, we estimate that up to approximately 218,215 
respondents will be submitting data under the advancing care 
information performance category, 195,022 clinicians, 668 groups or 
virtual groups, 15,945 group TINs within the Shared Savings Program 
ACOs, 100 group TINs within the APM Entity participating in CECs in the 
one-sided risk track, and 6,478 group TINs within the OCM (one-sided 
risk arrangement), and 2 CPC+ group TINs. We estimate this is a 
significant reduction in respondents from the 2017 MIPS performance 
period as a result of our

[[Page 53920]]

policy to provide significant hardship exceptions, including for MIPS 
eligible clinicians in small practices, as well as for situations due 
to decertification of an EHR, and our policy to allow eligible 
clinicians to participate as part of a virtual group.
    In the CY 2017 Quality Payment Program final rule, our burden 
estimates assumed all clinicians who submitted quality data would also 
submit under the advancing care information performance category. For 
this final rule with comment period, MIPS special status eligibility 
data were available to model exceptions. The majority (267,065) of the 
difference in our estimated number of respondents is due to the 
availability of MIPS special status data to identify clinicians and 
groups that would also not need to report advancing care information 
data under transition year policies, including hospital-based eligible 
clinicians, clinician types eligible for automatic reweighting of their 
advancing care information performance category score, non-patient 
facing clinicians, and clinicians facing a significant hardship. The 
remaining decline in respondents is due to policies established in this 
final rule with comment period, including 42,951 respondents who would 
be excluded under the finalized significant hardship exception for 
small practices. We also do not include clinicians in ambulatory 
surgical centers.
    Our burden estimates in the CY 2017 Quality Payment Program final 
rule assumed that during the transition year, 3 hours of clinician time 
would be required to collect and submit advancing care information 
performance category data. We anticipate that the year-over-year 
consistency of data submission processes, measures, and activities and 
the further alignment of the advancing care information performance 
category with other performance categories will reduce the clinician 
time needed under this performance category in the 2018 MIPS 
performance period. Further, for some practices the staff mix 
requirements in the 2018 MIPS performance period may be driven more by 
transition to 2015 CEHRT. Therefore, as shown in Table 66, the total 
burden hours for an organization to submit data on the specified 
Advancing Care Information Objectives and Measures is estimated to be 3 
incremental hours of a computer analyst's time above and beyond the 
clinician, practice manager, and computer system's analyst time 
required to submit quality data. The total estimated burden hours are 
654,645 (218,215 respondents x 3 hours). At a computer systems 
analyst's hourly rate, the total burden cost is $57,674,225 (218,215 x 
$264.30/hour).

  Table 66--Estimated Burden for Advancing Care Information Performance
                        Category Data Submission
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of respondents submitting advancing care information           218,215
 data on behalf of clinicians (a).......................
Estimated Total Annual Burden Hours Per Respondent (b)..               3
Estimated Total Annual Burden Hours (c) = (a) * (b).....         654,645
Estimated Cost Per Respondent to Submit Advancing Care           $264.30
 Information data (@computer systems analyst's labor
 rate of $88.10/hr.) (d)................................
Estimated Total Annual Burden Cost (e) = (a) * (d)......     $57,674,225
------------------------------------------------------------------------

    The following is a summary of the public comments received 
regarding our request for information on our burden estimates regarding 
the advancing care information performance category.
    Comment: Several commenters shared concerns regarding the 
complexity and burden of the advancing care information performance 
category.
    Response: We acknowledge the commenters' concerns regarding the 
advancing care information performance category's complexity. We 
anticipate a reduction in the burden of reporting advancing care 
information performance category measures as eligible clinicians, and 
organizations reporting on their behalf, become more familiar with, and 
have adapted to, the measure specifications.
    Comment: One commenter believed that CMS underestimated the amount 
of time and costs required to participate in the advancing care 
information performance category for its burden estimates because the 
objectives and measures require 3 incremental hours of a computer 
analyst's time in addition to the clinician's, practice manager's, and 
computer systems analyst's time required to submit quality data, at 
$88.10 per hour (wage) or $264.30. The commenter stated that, based on 
feedback from the commenter's members, the burden estimates (for both 
clinician times and staff) are significantly underestimated and urged 
CMS to review these estimates prior to increasing the reporting 
thresholds for the advancing care information performance category in 
the future.
    Response: We acknowledge the commenter's concerns regarding our 
time and cost estimates. Our estimates are grounded in reliable data 
sources, our assumptions are based in past program methodologies, and 
our analysis and justifications are detailed in this section of the 
final rule with comment period. We anticipate that most organizations 
will use the same data submission mechanism for the advancing care 
information and quality performance categories and that the clinicians, 
practice managers, and computer systems analysts involved in supporting 
the quality data submission will also support the advancing care 
information data submission process. Hence, the burden estimate for the 
submission of advancing care information data below shows only 
incremental hours required above and beyond the time already accounted 
for in the quality data submission process. Therefore, no changes were 
made to our burden estimates as a result of this comment.
    After consideration of public comments, no changes were made to the 
advancing care information performance category burden estimates from 
the CY 2018 Quality Payment proposed rules (82 FR 30227) as a result of 
comments specific to that performance category.
    The burden estimates were updated from the PQRS 2016 data to 
reflect updated data sources on the number of respondents. Our decision 
not to finalize implementing facility-based measurement (82 FR 30125) 
until the beginning of the 2019 performance period does not affect 
these numbers because we had selected facility-based clinicians from a 
subset of clinicians that could qualify for automatic reweighting.

H. ICR Regarding Burden for Improvement Activities Submission (Sec.  
414.1355)

    Requirements for submitting improvement activities did not exist in 
the legacy programs replaced by MIPS, and we do not have historical 
data

[[Page 53921]]

which is directly relevant. In section II.C.6.e.(3) of this final rule 
with comment period, we finalize that (1) for purposes of the 2020 MIPS 
payment year and future years and future payment years, MIPS eligible 
clinicians or groups must submit data on MIPS improvement activities in 
one of the following manners: via qualified registries; EHR submission 
mechanisms; QCDR, CMS Web Interface; or attestation. For activities 
that are performed for at least a continuous 90 days during the 
performance period, MIPS eligible clinicians must submit a yes response 
for activities within the Improvement Activities Inventory. In sections 
II.C.6.e.(2)(a) and II.C.6.e.(3)(b) of this final rule with comment 
period, we finalized that the term ``recognized'' is accepted as 
equivalent to the term ``certified'' when referring to the requirements 
for a patient-centered medical home and would receive full credit for 
the improvement activities performance category. We also note that for 
the 2020 MIPS payment year and future years, to receive full credit as 
a certified or recognized patient-centered medical home or comparable 
specialty practice, at least 50 percent of the practice sites within 
the TIN must be recognized as a patient-centered medical home or 
comparable specialty practice. Finally, in the CY 2017 Quality Payment 
Program final rule, we describe how we determine MIPS APM scores (81 FR 
77185). We compare the requirements of the specific MIPS APM with the 
list of activities in the Improvement Activities Inventory and score 
those activities in the same manner that they are otherwise scored for 
MIPS eligible clinicians. If, by our assessment, the MIPS APM does not 
receive the maximum improvement activities performance category score, 
then the APM Entity can submit additional improvement activities, 
although, as we noted, we anticipate that MIPS APMs in the 2018 MIPS 
performance period will not need to submit additional improvement 
activities as the models will already meet the maximum improvement 
activities performance category score.
    A variety of organizations and in some cases, individual 
clinicians, will submit improvement activity performance category data. 
For clinicians who are not part of APMs, we assume that clinicians 
submitting quality data as part of a group or virtual group through the 
QCDR and registry, EHR, and CMS Web Interface submission mechanisms 
will also submit improvement activities data. As finalized in the CY 
2017 Quality Payment Program final rule (82 FR 77264), APM Entities 
only need to report improvement activities data if the CMS-assigned 
improvement activities score is below the maximum improvement 
activities score. Our CY 2018 Quality Payment Program final rule burden 
estimates assume all ACOs will receive the maximum CMS-assigned 
improvement activities score.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30228), 
we estimated 520,654 clinicians will submit improvement activities as 
individuals during the 2018 MIPS performance period, an estimated 3,818 
groups to submit improvement activities on behalf of clinicians during 
the 2018 MIPS performance period, and an additional 16 virtual groups 
to submit improvement activities, resulting in 524,488 total 
respondents. However, the burden estimates have been updated from the 
CY 2018 Quality Payment Program proposed rule to reflect updated data 
sources on the number of respondents.
    In this final rule with comment period, we are updating our 
estimates to reflect an additional 923 groups for a total of 4,741 
based using the more recent 2016 PQRS data and 85,625 fewer clinicians 
reporting as individuals for the improvement activities performance 
category.
    As represented in Table 67, we estimate 435,029 clinicians will 
submit improvement activities as individuals during the 2018 MIPS 
performance period, an estimated 4,741 groups to submit improvement 
activities on behalf of clinicians during the 2018 MIPS performance 
period, and an additional 16 virtual groups to submit improvement 
activities, resulting in 439,786 total respondents. The burden 
estimates assume there will be no improvement activities burden for 
MIPS APM participants. We will assign the improvement activities 
performance category score at the APM level. We assume that the MIPS 
APM models for the 2018 MIPS performance period would qualify for the 
maximum improvement activities performance category score and the APM 
Entities would not need to submit any additional improvement 
activities.

   Table 67--Estimated Numbers of Organizations Submitting Improvement
      Activities Performance Category Data on Behalf of Clinicians
------------------------------------------------------------------------
                                                               Count
------------------------------------------------------------------------
Estimated # of clinicians to participate in improvement          435,029
 activities data submission as individuals during the
 2018 MIPS performance period (a).......................
Estimated # of Groups to submit improvement activities             4,741
 on behalf of clinicians during the 2018 MIPS
 performance period (b).................................
Estimated # of Virtual Groups to submit improvement                   16
 activities on behalf of clinicians during the 2018 MIPS
 performance period (c).................................
Total # of Respondents (Groups, Virtual Groups, and              439,786
 Individual Clinicians) to submit improvement activities
 data on behalf of clinicians during the 2018 MIPS
 performance period (d) = (a) + (b) + (c)...............
------------------------------------------------------------------------

    In Table 68, we estimate that approximately 439,786 respondents 
will be submitting data under the improvement activities performance 
category. Our burden estimates in the CY 2017 Quality Payment Program 
final rule assumed that during the transition year, 2 hours of 
clinician time would be required to submit data on the specified 
improvement activities. For this final rule with comment period, our 
burden estimate assumes that the total burden hours to submit data on 
the specified improvement activities will be 1 hour of computer system 
analyst time in addition to time spent on other performance categories. 
Our revised estimate is based on changes we made to include additional 
new high-weighted activities that were in response to comments from 
stakeholders (82 FR 30052). The addition of more high-weighted 
activities means that some clinicians will need to spend less time 
selecting activities because they may be able to select only two high-
weighted activities instead of four medium-weighted activities.
    Additionally, the same improvement activity may be reported across 
multiple performance periods so many MIPS eligible clinicians will not 
have any additional information to develop for the 2018 MIPS 
performance period. The total estimated burden hours are

[[Page 53922]]

439,786 (439,786 responses X 1 hour). At a computer systems analyst's 
hourly rate, the total burden cost is $38,745,147 (439,786 x $88.10/
hour). This is based on updated data from PQRS 2016.

    Table 68--Estimated Burden for Improvement Activities Submission
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total # of Respondents (Groups, Virtual Groups, and              439,786
 Individual Clinicians) to submit improvement activities
 data on behalf of clinicians during the 2018 MIPS
 performance period (a).................................
Estimated Total Annual Burden Hours Per Respondent (b)..               1
Estimated Total Annual Burden Hours (c).................         439,786
Estimated Cost Per Respondent to submit improvement               $88.10
 activities (@computer systems analyst's labor rate of
 $88.10/hr.) (d)........................................
Estimated Total Annual Burden Cost (e) = (a) * (d)......     $38,745,147
------------------------------------------------------------------------

    The following is a summary of the public comments received 
regarding our burden estimates for submission of improvement 
activities.
    Comment: One commenter did not dispute the time estimation (524,488 
clinicians that are not part of APMs will submit improvement activities 
taking one hour each) but expressed concern that CMS is not considering 
the direct costs charged by vendors for submitting improvement 
activities via qualified registry and/or EHR, which can be substantial 
as reflected in the updated qualified registries and QCDR lists for the 
MIPS 2017 performance period.
    Response: The costs and benefits are discussed in section VI.F. of 
this final rule with comment period. Since the burden estimates in this 
section address time costs, not direct financial costs, no changes were 
made to the burden estimate for direct costs charged by vendors for 
submitting improvement activities as a result of this comment.
    After consideration of public comments, we made no changes to the 
improvement activities submission burden estimates from the CY 2018 
Quality Payment Program proposed rule (82 FR 30228). The burden 
estimates were updated from the CY 2018 Quality Payment Program 
proposed rule to reflect updated data sources on the number of 
respondents.

I. ICR Regarding Burden for Nomination of Improvement Activities Sec.  
414.1360)

    For the 2018 MIPS performance period, we finalizing to formalize to 
allow clinicians, groups, and other relevant stakeholders to nominate 
new improvement activities using a nomination form provided on the 
Quality Payment Program Web site at qpp.cms.gov, and to send their 
proposed new improvement activities to us via email. As shown in Table 
69, based on a response to an informal call for new proposed 
improvement activities during the transition year, we estimate that 
approximately 150 organizations (clinicians, groups or other relevant 
stakeholders) will nominate new improvement activities. We estimate it 
will take an estimated 0.5 hours per organization to submit an activity 
to us, including an estimated 0.3 hours per practice for a practice 
administrator to make a strategic decision to nominate that activity 
and submit an activity to us via email at a rate of $105.16/hour for a 
total of $31.55 per activity and clinician review time of 0.2 hours at 
a rate of $202.08/hour for a total of $40.42 per activity. We estimate 
that the total annual burden cost is $10,796 (150 x $71.96).

   Table 69--Estimated Burden for Nomination of Improvement Activities
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Organizations Nominating New Improvement Activities             150
 (a)....................................................
Estimated # of Hours Per Practice Administrator to                  0.30
 Identify and Propose Activity (b)......................
Estimated # of Hours Per Clinician to Identify Activity             0.20
 (c)....................................................
Estimated Annual Burden Hours Per Respondent (d) = (b) +            0.50
 (c)....................................................
Estimated Total Annual Burden Hours (e) = (a) * (d).....           75.00
Estimated Cost to Identify and Submit Activity                    $31.55
 (@practice administrator's labor rate of $105.16/hr.)
 (f)....................................................
Estimated Cost to Identify Improvement Activity                   $40.42
 (@physician's labor rate of $202.08/hr.) (g)...........
Estimated Total Annual Cost Per Respondent (h) = (f) +            $71.97
 (g)....................................................
Estimated Total Annual Burden Cost (i) = (a) * (h)......         $10,796
------------------------------------------------------------------------

    We did not receive comments specific to our burden estimates for 
nomination of improvement activities. The burden estimates have not 
been updated from the CY 2018 Quality Payment Program proposed rule (82 
FR 30229).

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

    The cost performance category relies on administrative claims data. 
The Medicare Parts A and B claims submission process is used to collect 
data on cost measures from MIPS eligible clinicians. MIPS eligible 
clinicians are not requested to provide any documentation by CD or 
hardcopy. Therefore, under the cost performance category, we do not 
anticipate any new or additional submission requirements for MIPS 
eligible clinicians. We did not receive comments specific to cost 
performance category and no changes were made to this section.

K. ICR Regarding Partial QP Elections (Sec.  414.1430)

    APM Entities may face a data submission burden under MIPS related 
to Partial QP elections. Advanced APM participants will be notified 
about their QP or Partial QP status before the end of the performance 
period. For Advanced APMs the burden of partial QP election would be 
incurred by a representative of the participating APM Entity. For the 
purposes of this burden estimate, we assume that all MIPS

[[Page 53923]]

eligible clinicians determined to be Partial QPs will participate in 
MIPS.
    Based on our analyses of the initial QP determination file as 
described in the 2017 Quality Payment Program final rule (81 FR 77444), 
we assume that approximately 17 APM Entities will face the data 
submission requirement in the 2018 performance period.
    As shown in Table 70, we assume that 17 APM Entities will make the 
election to participate as a partial QP in MIPS. We estimate it will 
take the APM Entity representative 15 minutes to make this election. 
Using a computer systems analyst's hourly labor cost, we estimate a 
total burden cost of just $375 (17 participant x $22.03).

           Table 70--Estimated Burden for Partial QP Election
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of APM Entities Electing Partial QP Status on behalf                17
 of their Participants (a)..............................
# of Organizations Electing Partial QP Status on Behalf               17
 of Advanced APM Participants (c) = (a) + (b)...........
Estimated Burden Hours Per Respondent to Elect to                   0.25
 Participate as Partial QP (d)..........................
Estimated Total Annual Burden Hours (e) = (c) * (d).....            4.25
Estimated Cost Per Respondent to Elect to Participate as          $22.03
 Partial QP (@computer systems analyst's labor rate of
 $88.10/hr.) (f)........................................
Estimated Total Annual Burden Cost (g) = (c) * (f)......            $375
------------------------------------------------------------------------

    We did not receive comments specific to our burden estimates for 
partial QP elections. Our burden estimates for partial QP elections 
have not been changed from the CY 2018 Quality Payment Program proposed 
rule (82 FR 30229).

L. ICRs Regarding Other Payer Advanced APM Determinations: Payer-
Initiated Process (Sec.  414.1440) and Medicaid Specific Eligible 
Clinician Initiated Process (Sec.  414.1445)

1. Payer Initiated Process
    Beginning in Quality Payment Program Year 3, the All-Payer 
Combination Option will be an available pathway to QP status for 
eligible clinicians participating sufficiently in Advanced APMs and 
Other Payer Advanced APMs. The All-Payer Combination Option allows for 
eligible clinicians to achieve QP status through their participation in 
both Advanced APMs and Other Payer Advanced APMs. In order to include 
an eligible clinician's participation in Other Payer Advanced APMs in 
their QP threshold score, we will need to determine if certain payment 
arrangements with other payers meet the criteria to be Other Payer 
Advanced APMs. To provide eligible clinicians with advanced notice 
prior to the start of the 2019 performance period, and to allow other 
payers to be involved prospectively in the process, we finalized in 
section II.D.6.c.(1)(b) of this final rule with comment period a payer-
initiated identification process for identifying payment arrangements 
that qualify as Other Payer Advanced APMs. This payer-initiated 
identification process of Other Payer Advanced APMs will begin in CY 
2018, and determinations would be applicable for the Quality Payment 
Program Year 3.
    As shown in Table 71, we estimate that 300 other payer arrangements 
will be submitted (50 Medicaid payers, 150 Medicare Advantage 
Organizations, and 100 Multi-payers) for identification as Other Payer 
Advanced APMs. The estimated burden to apply is 10 hours per payment 
arrangement, for a total annual burden hours of 3,000 (300 X 100). We 
estimate a total cost per payer of $881.00 using a computer system 
analyst's rate of $88.10/hour (10 X 81.10). The total annual burden 
cost for all other payers is $264,300 (300 X $881.00).

      Table 71--Burden for Other Payer Advanced APM Identification
                 Determinations: Payer-Initiated Process
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Estimated # of other payer payment arrangements (50                  300
 Medicaid, 150 Medicare Advantage Organizations, 100
 Multi-payers) (a)......................................
Estimated Total Annual Burden Hours Per other payer                   10
 payment arrangement (b)................................
Estimated Total Annual Burden Hours (c) = (a) * (b).....           3,000
Estimated Cost Per Other Payer (@computer systems                $881.00
 analyst's labor rate of $88.10/hr.) (d)................
Estimated Total Annual Burden Cost for Other Payer              $264,300
 Advanced APM determinations (e) = (a) * (d)............
------------------------------------------------------------------------

    The following is a summary of the public comments received 
regarding our request for information on our burden estimates for Other 
Payer Advanced APM identification: Payer-Initiated Process.
    Comment: One commenter noted that in Table 84 of the CY 2018 
Quality Payment Program proposed rule (82 FR 30230), CMS suggests that 
300 organizations would request an Other Payer Advanced APM 
Identification: Payer Initiated Process and that the total hours to 
prepare such requests per organization would be 10 hours at a cost of 
$88.10. Given that it says Payer Initiated Process, the commenter noted 
that it is assumed this reflects the number of plans that will request 
model approval. The commenter requested clarification regarding why CMS 
does not include an estimate for the APM Entity Initiated process and 
inquired whether CMS does not believe any clinicians will endeavor to 
get models approved. It is also unclear why the process through which 
clinicians request an All-Payer Combination QP calculation does not 
appear to be accounted for in CMS's burden estimates. The commenter 
believed that clinicians will choose to do so, and that CMS should 
transparently acknowledge that it will be quite burdensome on these 
clinicians.
    Response: In response to the public comment, we have added a burden 
estimate, which is included in Table 72, for the Medicaid specific 
Eligible Clinician Initiated Process where APM Entities and eligible 
clinicians can request to have Medicaid payment arrangements they are 
participating in assessed to determine if they are Other Payer Advanced 
APMs. For non-Medicare payers other than Medicaid, we did not include 
the burden estimate for the Eligible Clinician Initiated

[[Page 53924]]

process because in 2018, only the Payer Initiated Process through which 
other payers can request CMS make determinations prospectively as to 
whether payment arrangements qualify as Other Payer Advanced APMs is 
available. We will include the burden estimate for the Eligible 
Clinician Initiated process in the CY 2019 Quality Payment Program 
proposed rule.
    After consideration of public comments, we made no changes to the 
Other Payer Advanced APM Identification: Payer-Initiated Process burden 
from the CY 2018 Quality Payment Program proposed rule (82 FR 30230), 
and have added the burden for the Medicaid specific Eligible Clinician 
Initiated Process in this section of the final rule with comment 
period.
2. Medicaid Specific Eligible Clinician Initiated Process (Sec.  
414.1445)
    Beginning in Quality Payment Program Year 3, the All-Payer 
Combination Option will be an available pathway to QP status for 
eligible clinicians participating sufficiently in Advanced APMs and 
Other Payer Advanced APMs. The All-Payer Combination Option allows for 
eligible clinicians to achieve QP status through their participation in 
both Advanced APMs and Other Payer Advanced APMs. In order to include 
an eligible clinician's participation in Other Payer Advanced APMs in 
their QP threshold score, we will need to determine if certain payment 
arrangements with other payers meet the criteria to be Other Payer 
Advanced APMs.
    To provide eligible clinicians with advanced notice prior to the 
start of the 2019 performance period, and to allow other payers to be 
involved prospectively in the process, we finalized in section 
II.D.6.c.(1) of this final rule with comment period a payer-initiated 
identification process for identifying payment arrangements that 
qualify as Other Payer Advanced APMs. However, to appropriately 
implement the Title XIX exclusions, we determined it was not feasible 
to allow APM Entities and eligible clinicians to request determinations 
for Title XIX payment arrangements after the conclusion of the All-
Payer QP. To do so would mean that a single clinician requesting a 
determination for a previously unknown Medicaid APM or Medicaid Medical 
Home Model that meets the Other Payer Advanced APM criteria could 
unexpectedly affect QP threshold calculations for every other clinician 
in that state (or county) as described in section II.D.6.c.(3)(b) of 
the proposed rule. Thus, we also finalized in section II.D.6.c.(3) of 
this final rule with comment period that APM Entities and eligible 
clinicians may request determinations for any Medicaid payment 
arrangements in which they are participating at an earlier point, prior 
to the start of the 2019 performance period. This would allow all 
clinicians in a given state or county to know before the beginning of 
the performance period whether their Title XIX payments and patients 
would be excluded from the all-payer calculations that are used for QP 
determinations for the year under the All-Payer Combination Option. 
This Medicaid specific eligible clinician-initiated determination 
process of Other Payer Advanced APMs will also begin in CY 2018, and 
determinations would be applicable for the Quality Payment Program Year 
3.
    As shown in Table 72, we estimate that 75 other payer arrangements 
will be submitted by APM Entities and eligible clinicians for 
identification as Other Payer Advanced APMs. The estimated burden to 
apply is 10 hours per payment arrangement, for a total annual burden 
hours of 1,500 (150 x 10). We estimate a total cost per payer of 
$881.00 using a computer system analyst's rate of $88.10/hour (10 x 
81.10). The total annual burden cost for all other payers is $66,075 
(75 x $881.00).

 Table 72--Burden for Other Payer Advanced APM Determinations: Medicaid
              Specific Eligible Clinician Initiated Process
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Estimated # of other payer payment arrangements from APM              75
 Entities and eligible clinicians.......................
Estimated Total Annual Burden Hours Per other payer                   10
 payment arrangement (b)................................
Estimated Total Annual Burden Hours (c) = (a) * (b).....             750
Estimated Cost Per Other Payer (@computer systems                $881.00
 analyst's labor rate of $88.10/hr.) (d)................
Estimated Total Annual Burden Cost for Other Payer               $66,075
 Advanced APM determinations (e) = (a) * (d)............
------------------------------------------------------------------------

M. ICRs Regarding Burden for Voluntary Participants to Elect Opt Out of 
Performance Data Display on Physician Compare (Sec.  414.1395)

    We estimate 22,400 clinicians and groups who will voluntarily 
participate in MIPS but also will elect not to participate in public 
reporting. Table 73 shows that for these voluntary participants, they 
may submit a request to opt out which is estimated at 0.25 hours of a 
computer system analyst's labor rate of $88.10. The total annual burden 
hours for opting out is estimated at 5,600 hours (22,400 x 0.25). The 
total annual burden cost for opting out for all requesters is estimated 
at $493,472 (22,400 x $22.03).

     Table 73--Burden for Voluntary Participants To Elect Opt Out of
              Performance Data Display on Physician Compare
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Estimated # of Voluntary Participants Opting Out of               22,400
 Physician Compare (a)..................................
Estimated Total Annual Burden Hours Per Opt-out                     0.25
 Requester (b)..........................................
Estimated Total Annual Burden Hours for Opt-out                    5,600
 Requester (c) = (a) * (b)..............................
Estimated Cost Per Physician Compare Opt-out                      $22.03
 Request@computer systems analyst's labor rate of $88.10/
 hr.) (d)...............................................
Estimated Total Annual Burden Cost for Opt-out Requester        $493,472
 (e) = (a) * (d)........................................
------------------------------------------------------------------------


[[Page 53925]]

    We did not receive comments specific to our burden estimates for 
voluntary participants to elect opt out of performance data display on 
Physician Compare. The burden estimates are unchanged from the CY 2018 
Quality Payment Program proposed rule (82 FR 30230).

N. Summary of Annual Burden Estimates

    Table 74 includes our CY 2018 Quality Payment Program final rule 
with comment period burden estimates for annual recordkeeping and data 
submission of 7,589,445 hours with total labor cost of $694,183,802. In 
order to understand the burden implications of the policies finalized 
in this rule, we have also estimated a baseline burden of continuing 
the policies and information collections set forth in the CY 2017 
Quality Payment Program final rule into the 2018 performance period. 
This estimated baseline burden of 7,760,708 hours and a total labor 
cost of $708,101,886 is lower than the burden approved for information 
collection related to the CY 2017 Quality Payment Program final rule 
\46\ because we anticipate greater respondent familiarity with the 
measures and data submission methods in their second year of 
participation. Our baseline estimates are based on 2018 data, and 
therefore, do not exclude those individuals that were impacted by the 
hurricanes of 2017, Harvey, Irma and Maria that are referred to in the 
interim final rule with comment period pertaining to extreme and 
uncontrollable circumstances for the 2017 performance period. Further, 
our estimated baseline burden estimates reflect the recent availability 
of data sources to more accurately reflect the number of the 
organizations exempt from the advancing care information performance 
category and to more accurately reflect the exclusion of QPs from all 
MIPS performance categories.
---------------------------------------------------------------------------

    \46\ The burden estimate for the CY 2017 Quality Payment Program 
final rule was 10,940,417 hours for a total labor cost of 
$1,349,763,999. For comparability for the burden estimate in this CY 
2018 Quality Payment Program proposed rule, the burden estimate for 
the CY 2017 Quality Payment Program final rule has been updated 
using 2016 wages.
---------------------------------------------------------------------------

    We estimate that this final rule with comment period will decrease 
burden by 171,264 hours and $13.9 million in labor costs relative to 
the estimated baseline of continued transition year policies. The 
Quality Payment Program Year 2 reduction in burden based on policies 
established in this final rule reflects several finalized policies, 
including our finalized policy for a new significant hardship exception 
for small practices for the advancing care information performance 
category, reduced length of the CAHPS survey and the finalized policy 
to allow MIPS eligible clinicians to form virtual groups, which would 
create efficiencies in data submission.

                                               Table 74--Annual Recordkeeping and Submission Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Respondents/      Hours per     Total annual                                                  Total annual
                                               responses       response      burden hours             Labor cost of submission              burden cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registration for Virtual Groups...........              16            10.0             160  Varies (See Table 51).......................         $13,313
QCDR and Registries self-nomination.......             233            10.0           2,330  $88.10......................................         439,786
CAHPS Survey Vendor Application...........              15            10.0             150  $88.10......................................          13,215
(Quality Performance Category) Claims              278,039            17.8       4,949,094  Varies (See Table 57).......................     454,977,459
 Submission Mechanism.
(Quality Performance Category) Qualified           107,217             9.1         973,852  Varies (See Table 58).......................      91,247,028
 Registry or QCDR Submission Mechanisms.
(Quality Performance Category) EHR-                 54,218             9.0         487,962  Varies (See Table 59).......................      45,762,161
 Submission Mechanism.
(Quality Performance Category) CMS Web                 296            74.0          21,904  $88.10......................................       1,929,624
 Interface Submission Mechanism.
(Quality Performance Category)                          10             1.0              10  $88.10......................................             881
 Registration and Enrollment for CMS Web
 Interface.
(CAHPS for MIPS Survey) Beneficiary                132,307            0.22          29,108  $23.86......................................         694,612
 Participation.
(CAHPS for MIPS Survey) Group Registration             461             1.5             692  $88.10......................................          60,921
Sec.   414.1375 (Advancing Care                     40,645             0.5          20,323  $88.10......................................       1,790,412
 Information) Performance Category
 Significant Hardships, including for
 small practices and decertification of
 EHRs.
(Advancing Care Information Performance            218,215             3.0         654,645  $88.10......................................      57,674,225
 Category) Data Submission.
(Improvement Activities Performance                439,786            1.00         439,786  $88.10......................................      38,745,147
 Category) Data Submission.
(Improvement Activities Performance                    150             0.5              75  Varies (See Table 69).......................          10,796
 Category) Call for Activities.
(Partial Qualifying APM Participant (QP)                17             0.3               4  $88.10......................................             375
 Election).
Other Payer Advanced APM Identification:               300            10.0           3,000  $88.10......................................         264,300
 Other Payer Initiated Process.
Other Payer Advanced APM Identification:                75            10.0             750  $88.10......................................          66,075
 Medicaid-Specific Clinician Initiated
 Process.
(Physician Compare) Opt Out for Voluntary           22,400             0.3           5,600  $88.10......................................         493,472
 Participants.
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................       1,294,400  ..............       7,589,445  ............................................     694,183,802
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 53926]]

    We did not receive comments specific to our summary of annual 
burden estimates. We have updated the numbers to reflect updates based 
on 2016 data and to reflect new assumptions, but no other changes were 
made.

O. Submission of PRA-Related Comments

    We have submitted a copy of this rule's information collection and 
recordkeeping requirements to OMB for review and approval. These 
requirements are not effective until they have been approved by the 
OMB.
    To obtain copies of the supporting statement and any related forms 
for the proposed collections discussed above, please visit CMS's Web 
site at www.cms.hhs.gov/PaperworkReductionActof1995, or call the 
Reports Clearance Office at 410-786-1326.
    We invite public comments on these potential information collection 
requirements. If you wish to comment, please identify the rule (CMS-
5522-FC) and submit your comments to the OMB desk officer via one of 
the following transmissions: Mail: OMB, Office of Information and 
Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: 202-395-
5806 OR, Email: OIRA@[email protected]. We will consider all ICR 
related comments we receive by the date and time specified in the DATES 
section of the preamble, and, when we proceed with a subsequent 
document, we will respond to the comments in the preamble to that 
document.

P. Collection of Information Requirements for the Interim Final Rule 
With Comment Period: Medicare Program; Quality Payment Program: Extreme 
and Uncontrollable Circumstance Policy for the Transition Year

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping, or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

V. Response to Comments

    Because of the large number of public comments, we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

VI. Regulatory Impact Analysis

A. Statement of Need

    This final rule with comment period is necessary to make 
statutorily required policy changes and other policy updates to the 
Merit-based Incentive Payment System (MIPS) established under MACRA as 
well as the policies related to the Advanced APM provisions of MACRA, 
which together are referred to as the Quality Payment Program. As 
required by MACRA, MIPS consolidates several quality programs, 
including components of the Medicare Electronic Health Record Incentive 
Program, the Physician Quality Reporting System (PQRS), and the 
Physician Value-Based Payment Modifier (VM) and Physician Feedback 
Program. MACRA effectively ends these programs after CY 2018 and 
authorizes MIPS' operation beginning with payments under Part B for 
items and services furnished in CY 2019.
    The Quality Payment Program is structured to improve care quality 
over time with input from clinicians, patients, and other stakeholders. 
We have sought and continue to seek feedback from the health care 
community through various public avenues such as listening sessions, 
request for information and rulemaking where we have received feedback 
that many clinical practices are still working towards implementing the 
Quality Payment Program. This final rule with comment period for 
Quality Payment Program Year 2 reflects this feedback and includes 
several policies that extend transition year policies finalized in the 
CY 2017 Quality Payment Program final rule with comment period; 
however, we also include policies to begin ramping up to full 
implementation, since the MIPS performance threshold must be the mean 
or median of the final scores for all MIPS eligible clinicians for a 
prior period starting in the 2019 MIPS performance period (2021 MIPS 
payment year). Additionally, we noted in the proposed rule that we 
address elements of MACRA that were not included in the first year of 
the program, including virtual groups, facility-based measurement, and 
improvement scoring (82 FR 30010). We also include policies to continue 
implementing elements of MACRA that do not take effect in the first or 
second year of the Quality Payment Program, including policies related 
to the All-Payer Combination Option for the APM incentive.

B. Overall Impact

    We have examined the impact of this final rule with comment period 
as required by Executive Order 12866 on Regulatory Planning and Review 
(September 30, 1993), Executive Order 13563 on Improving Regulation and 
Regulatory Review (February 2, 2013), the Regulatory Flexibility Act 
(Pub. L. 96-354 enacted September 19, 1980) (RFA), section 1102(b) of 
the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. 
L. 14-04 enacted March 22, 1995), Executive Order 13132 on Federalism 
(August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and 
Executive Order 13771 on Reducing Regulation and Controlling Regulatory 
Costs (January 30, 2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
We estimate, as discussed below in this section, that the Medicare Part 
B provisions included in this final rule with comment period will 
redistribute more than $118 million in budget neutral payments in the 
second performance year. In addition, as specified by Section 101 of 
the MACRA this final rule with comment period will increase government 
outlays for the exceptional performance payment adjustments under MIPS 
($500 million), and incentive payments to QPs (approximately $675 to 
$900 million). Overall, this rule will transfer more than $1 billion in 
payment adjustments for MIPS eligible clinicians and incentive payments 
to QPs. Therefore, we estimate that this rulemaking is ``economically 
significant'' as measured by the $100 million threshold, and hence also 
a major rule under the Congressional Review Act. Accordingly, we have 
prepared a RIA that, to the best of our ability, presents the costs and 
benefits of the rulemaking.
    Executive Order 13771, titled Reducing Regulation and Controlling 
Regulatory Costs, was issued on January 30, 2017. This final rule is 
considered an EO 13771 deregulatory action. As shown in the discussion 
of Table 84 in the Collection of Information section of this final rule 
with comment period, we estimate that this final rule with

[[Page 53927]]

comment period would reduce the ICR burden by 171,264 hours and would 
result in a further reduction in burden costs of $13.9 million in the 
Quality Payment Program Year 2 relative to Quality Payment Program Year 
1. As discussed in section VI.C.6 of this final rule with comment 
period, we are unable to quantify the compliance costs with the 
advancing care information and improvement activities performance 
category requirements. However, we believe this final rule with comment 
period has removed the performance category requirements for a large 
number of clinicians, and therefore, would overall be a reduction in 
the overall cost of compliance to clinicians relative to transition 
year policies. We believe that clinicians who complied with the 
requirements of the advancing care information performance category or 
improvement activities performance category in the transition year, 
there would be no additional costs of compliance for this final rule 
with comment period. For advancing care information performance 
category, clinicians can opt to use the same measures in the 2018 
performance period as in the transition year. For the improvement 
activities performance category, we anticipate that for the vast 
majority of MIPS eligible clinicians, the activities needed to comply 
with the requirements of this final rule with comment period would be 
the same as the activities required to comply with transition year 
policies. As shown in the discussion of Regulatory Review Costs in 
section VI.E. of this final rule with comment period, we estimate that 
total regulatory review costs associated with the Quality Payment 
Program would be approximately $2.2 million.
    The RFA requires agencies to prepare an Initial Regulatory 
Flexibility Analysis to describe and analyze the impact of the final 
rule on small entities unless the Secretary can certify that the 
regulation will not have a significant impact on a substantial number 
of small entities. The RFA requires agencies to analyze options for 
regulatory relief of small entities. Note that Small Business 
Administration (SBA) standards for small entities differ than the 
definition of a small practice under MIPS finalized in the CY 2017 
Quality Payment Program final rule under Sec.  414.1305. The SBA 
standard for a small business is $11 million in average receipts for an 
office of clinicians and $7.5 million in average annual receipts for an 
office of other health practitioners. (For details, see the SBA's Web 
site at http://www.sba.gov/content/table-small-business-size-standards 
(refer to the 620000 series)).
    Approximately 95 percent of practitioners, other providers, and 
suppliers are considered to be small entities either by nonprofit 
status or by having annual revenues that qualify for small business 
status under the SBA standards. There are over 1 million physicians, 
other practitioners, and medical suppliers that receive Medicare 
payment under the PFS. Because many of the affected entities are small 
entities, the analysis and discussion provided in this RIA section as 
well as elsewhere in this final rule with comment period is intended to 
comply with the requirement for a Final Regulatory Flexibility Analysis 
(FRFA).
    As discussed below, approximately 622,000 MIPS eligible clinicians 
will be required to submit data under MIPS. This represents just over 
50 percent of clinicians who meet the statutory requirements of being 
eligible clinician and not being newly enrolled (approximately 622,000 
out of 1.2 million who are eligible and not newly enrolled.) As shown 
later in this analysis, however, potential reductions in Medicare Part 
B payment for MIPS eligible clinicians under the MIPS are a certain 
percentage of their total Medicare Part B paid charges--5 percent in 
the 2020 MIPS payment year--though rising to as high as 9 percent in 
subsequent years. On average, clinicians' Medicare billings are only 
approximately 23 percent of their total revenue,\47\ so even those MIPS 
eligible clinicians that receive the maximum negative MIPS payment 
adjustment under MIPS would rarely face losses in excess of 3 percent 
of their total revenues, the HHS standard for determining whether an 
economic effect is ``significant.'' (In order to determine whether a 
rule meets the RFA threshold of ``significant'' impact, HHS has, for 
many years, used as a standard adverse effects that exceed 3 percent of 
either revenues or costs.) However, because there are so many affected 
MIPS eligible clinicians, even if only a small proportion is 
significantly adversely affected, the number could be ``substantial.'' 
Therefore, we are unable to conclude that an FRFA is not required. 
Accordingly, the analysis and discussion provided in this section, as 
well as elsewhere in this final rule with comment period, together meet 
the requirements for an FRFA. We note that whether or not a particular 
MIPS eligible clinician or other eligible clinician is adversely 
affected would depend in large part on the performance of that MIPS 
eligible clinician or other eligible clinician, and that CMS will offer 
significant technical assistance to MIPS eligible clinicians and other 
eligible clinicians in meeting the new standards.
---------------------------------------------------------------------------

    \47\ Based on National Health Expenditure Data, Physicians and 
Clinical Services Expenditures, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsProjected.html.
---------------------------------------------------------------------------

    For the 2018 MIPS performance period, this final rule with comment 
period has several key policies that will provide regulatory relief for 
clinicians and practices and help increase ways for successful 
participation. These include implementing virtual groups, raising the 
low volume threshold, continuing to allow the use of 2014 Edition 
CEHRT, and adding a new significant hardship exception for the 
advancing care information performance category for MIPS eligible 
clinicians who are in small practices, as summarized in section I.D.4 
of this final rule with comment period.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small hospitals located in rural areas. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small hospital 
located in a rural area as a hospital that is located outside of a 
Metropolitan Statistical Area for Medicare payment regulations and has 
fewer than 100 beds. We are not preparing an analysis for section 
1102(b) of the Act because we have determined, and the Secretary 
certifies, that this final rule with comment period would not have a 
significant impact on the operations of a substantial number of small 
hospitals located in rural areas.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits on state, 
local, or tribal governments or on the private sector before issuing 
any rule whose mandates require spending in any 1 year of $100 million 
in 1995 dollars, updated annually for inflation. In 2017, that 
threshold is approximately $148 million. This final rule with comment 
period imposes no mandates on state, local, or tribal governments or on 
the private sector because participation in Medicare is voluntary and 
because physicians and other clinicians have multiple options as to how 
they will participate under MIPS and discretion over their performance. 
Moreover, HHS interprets UMRA as applying only to unfunded mandates. We 
do not interpret Medicare payment

[[Page 53928]]

rules as being unfunded mandates, but simply as conditions for the 
receipt of payments from the federal government for providing services 
that meet federal standards. This interpretation applies whether the 
facilities or providers are private, state, local, or tribal.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct effects on state and local 
governments, preempts state law, or otherwise has Federalism 
implications. We have outlined in section II.D.6.b. of this final rule 
with comment period a payer-initiated identification process for 
identifying which payment arrangements qualify as Other Payer Advanced 
APMs. State Medicaid programs may elect to participate in the payer-
initiated identification process. Beginning in Quality Payment Program 
Year 3, the All-Payer Combination Option will be an available pathway 
to QP status for eligible clinicians participating sufficiently in 
Advanced APMs and Other Payer Advanced APMs. The All-Payer Combination 
Option allows for eligible clinicians to achieve QP status through 
their participation in both Advanced APMs and Other Payer Advanced 
APMs. To include an eligible clinician's participation in Other Payer 
Advanced APMs in their QP threshold score, we will need to determine if 
certain payment arrangements with other payers meet the criteria to be 
Other Payer Advanced APMs (Medicaid Specific Eligible Clinician 
Initiated Process (Sec.  414.1445)). We do not believe any of these 
policies impose a substantial direct effect on the Medicaid program as 
participation in the Payer Initiated Determination Process is voluntary 
and use of the Eligible Clinician Initiated Determination Process is 
also voluntary.
    We note that we are also adopting policies in an interim final rule 
with comment period that address extreme and uncontrollable 
circumstances MIPS eligible clinicians may face as a result of 
widespread catastrophic events affecting a region or locale in CY 2017, 
such as Hurricanes Irma, Harvey and Maria. We have prepared the 
following analysis, which together with the information provided in the 
rest of this final rule with comment period, meets all assessment 
requirements. The analysis explains the rationale for and purposes of 
this final rule with comment period; details the costs and benefits of 
the rule; analyzes alternatives; and presents the measures we would use 
to minimize the burden on small entities. As indicated elsewhere in 
this final rule with comment period, we are implementing a variety of 
changes to our regulations, payments, or payment policies to implement 
statutory provisions. We provide information for each of the policy 
changes in the relevant sections of this final rule with comment 
period. We note that many of the MIPS policies from the CY 2017 Quality 
Payment Program final rule were only defined for the 2017 MIPS 
performance period and 2019 MIPS payment year (including the 
performance threshold, the performance category reweighting policies, 
and many scoring policies for the quality performance category) which 
precludes us from developing a baseline for the 2018 MIPS performance 
period and 2020 MIPS payment year if there were no new regulatory 
action. We are unaware of any relevant federal rules that duplicate, 
overlap, or conflict with this final rule with comment period. The 
relevant sections of this final rule with comment period contain a 
description of significant alternatives if applicable.

C. Changes in Medicare Payments

    Section 101 of MACRA, (1) repeals the Sustainable Growth Rate (SGR) 
formula for physician payment updates in Medicare, and (2) requires 
that we establish MIPS for eligible clinicians under which the 
Secretary must use a MIPS eligible clinician's final score to determine 
and apply a MIPS payment adjustment factor to the clinician's Medicare 
Part B payments for items and services (which includes services under 
the Physician Fee Schedule, Part B drugs and other Part B payments) for 
a year.
    The largest component of MACRA costs is its replacement of 
scheduled reductions in physician payments with payment rates first 
frozen at 2015 levels and then increasing at a rate of 0.5 percent a 
year during CYs 2016 through 2019. The estimates in this RIA take those 
legislated rates as the baseline for the estimates we make as to the 
costs, benefits, and transfer effects of this final regulation, with 
some data submission provisions for the 2018 MIPS performance period 
taking effect in 2018 and 2019, and the corresponding positive and 
negative payment adjustments taking effect in the 2020 MIPS payment 
year.
    As required by MACRA, overall payment rates for services for which 
payment is made under the PFS would remain at the 2019 level through 
2025, but starting in 2019, the amounts paid to individual MIPS 
eligible clinicians and other eligible clinicians would be subject to 
adjustment through one of two mechanisms, depending on whether the 
clinician achieves the threshold for participation in Advanced APMs to 
be considered a QP or Partial QP, or is instead evaluated under MIPS.
1. Estimated Incentive Payments to QPs in Advanced APMs
    From 2019 through 2024, eligible clinicians receiving a sufficient 
portion of Medicare Part B payments for covered professional services 
or seeing a sufficient number of Medicare patients through Advanced 
APMs as required to become QPs would receive a lump-sum APM Incentive 
Payment equal to 5 percent of their estimated aggregate payment amounts 
for Medicare covered professional services in the preceding year, as 
discussed in section II.D.5. of this final rule with comment period.
    The APM Incentive Payment is separate from, and in addition to, the 
payment for covered professional services furnished by an eligible 
clinician during that year. Eligible clinicians who become QPs for a 
year would not need to report to MIPS and would not receive a MIPS 
payment adjustment to their Part B payments. Eligible clinicians who do 
not become QPs, but meet a slightly lower threshold to become Partial 
QPs for the year, may elect to report to MIPS and would then be scored 
under MIPS and receive a MIPS payment adjustment, but do not receive 
the APM Incentive Payment. For the 2018 Medicare QP Performance Period, 
we define Partial QPs to be eligible clinicians in Advanced APMs who 
have at least 20 percent, but less than 25 percent, of their payments 
for Part B covered professional services through an Advanced APM 
Entity, or furnish Part B covered professional services to at least 10 
percent, but less than 20 percent, of their Medicare beneficiaries 
through an Advanced APM Entity. If the Partial QP elects to be scored 
under MIPS, they would be subject to all MIPS requirements and would 
receive a MIPS payment adjustment. This adjustment may be positive or 
negative. If an eligible clinician does not meet either the QP or 
Partial QP standards, the eligible clinician would be subject to MIPS, 
would report to MIPS, and would receive the corresponding MIPS payment 
adjustment.
    Beginning in 2026, payment rates for services furnished by 
clinicians who achieve QP status for a year would be increased each 
year by 0.75 percent for the year, while payment rates for services 
furnished by clinicians who do not achieve QP status for the year would 
be increased by 0.25 percent. In addition, MIPS eligible clinicians 
would

[[Page 53929]]

receive positive, neutral, or negative MIPS payment adjustments to 
their Part B payments for items and services in a payment year based on 
performance during a prior performance period. Although MACRA 
amendments established overall payment rate and procedure parameters 
until 2026 and beyond, this impact analysis covers only the second 
payment year (2020) of the Quality Payment Program in detail. After 
2020, while overall payment levels will be partially bounded, we have 
also acknowledged in the preamble that the Department will likely 
revise its quality and other payment measures and overall payment 
thresholds and other parameters as clinicians' behavior changes.
    We estimate that between 185,000 and 250,000 eligible clinicians 
will become QPs, therefore be exempt from MIPS, and qualify for lump 
sum incentive payment based on 5 percent of their Part B allowable 
charges for covered professional services, which are estimated to be 
between approximately $13,500 million and $18,000 million in the 2018 
Quality Payment Program performance year. We estimate that the 
aggregate total of the APM incentive payment of 5 percent of Part B 
allowed charges for QPs would be between approximately $675 and $900 
million for the 2020 Quality Payment Program payment year. These 
estimates reflect longstanding HHS policy not to attempt to predict the 
effects of future rulemaking in order to maximize future Secretarial 
discretion over whether, and if so how, payment or other rules would be 
changed.
    We project the number of eligible clinicians that will be excluded 
from MIPS as QPs using several sources of information. First, the 
projections are anchored in the most recently available public 
information on Advanced APMs. The projections reflect APMs that will be 
operating in 2018. This final rule with comment period indicates which 
APMs would be Advanced APMs under the finalized policies, including the 
Next Generation ACO Model, Comprehensive Primary Care Plus (CPC+) 
Model, Comprehensive ESRD Care (CEC) Model (Two-Sided Risk 
Arrangement), Vermont All-Payer ACO Model,\48\ Comprehensive Care for 
Joint Replacement Payment Model (CEHRT Track), Oncology Care Model 
(Two-Sided Risk Arrangement), Medicare ACO Track 1+ Model, the Shared 
Savings Program Tracks 2 and 3. We also project Advanced APM 
participation based on applicant counts and estimated acceptance rates 
to Advanced APMs that had open application periods as of early 2017. We 
used the APM Participant Lists (see (81 FR 77444 through 77445 for 
information on the APM participant lists and QP determination) on the 
most recent MDM provider extract (March 31, 2017) for the Initial QP 
determination file for Performance Year 2017 to estimate QPs for 2018. 
We examine the extent to which Advanced APM participants would meet the 
QP thresholds of having at least 25 percent of their Part B covered 
professional services or at least 20 percent of their Medicare 
beneficiaries furnished Part B covered professional services through 
the Advanced APM Entity.
---------------------------------------------------------------------------

    \48\ Vermont ACOs will be participating in an Advanced APM 
during 2018 through a modified version of the Next Generation ACO 
Model. The Vermont Medicare ACO Initiative will be an Advanced APM 
beginning in 2019.
---------------------------------------------------------------------------

2. Estimated Numbers of Clinicians Eligible for MIPS
    Certain clinicians may not be eligible to participate or may be 
excluded from participation in MIPS for various reasons. For example, 
MACRA requires us to limit eligibility for the 2019 and 2020 MIPS 
payment years to specified clinician types. Additionally, we exclude 
eligible clinicians with billings that do not exceed the low volume 
threshold as finalized in section II.C.2.c. of this final rule with 
comment period: Those with $90,000 or less in Part B allowed charges or 
200 or fewer Medicare Part B patients as measured at the TIN/NPI level 
for individual reporting, the TIN level for group reporting, the APM 
Entity level for reporting under the APM scoring standard. We also 
exclude those who are newly enrolled to Medicare and those eligible 
clinicians who are QPs.
    To estimate the number of clinicians that are not in MIPS due to an 
ineligible clinician type for CY 2018, our scoring model used the first 
2019 Payment Year MIPS eligibility file as described in 81 FR 77069 
through 77070. The data file included 1.5 million clinicians who had 
Medicare Part B claims from September 1, 2015 to August 31, 2016 and 
included a 60-day claim run-out. We limited our analysis to those 
clinicians identified as MIPS eligible clinician types for the 2020 
MIPS payment year: Doctors of medicine, doctors of osteopathy, 
chiropractors, dentists, optometrists, podiatrists, nurse 
practitioners, physician assistants, certified registered nurse 
anesthetists, and clinical nurse specialists.
    We estimated the number of clinicians excluded for low volume by 
comparing the allowed Medicare Part B charges in the first 2019 MIPS 
payment year eligibility file to the finalized low volume threshold. We 
used 2016 PQRS reporting data to determine whether clinicians have 
historically reported as a group and whether to make the low-volume 
determination at the individual (TIN/NPI) or group (TIN) level. We 
assumed all 2016 ACO participants (including participants from Shared 
Savings Program or Pioneer or Next Generation ACO Models) would exceed 
the low volume threshold because the ACOs are required to have a 
minimum number of assigned beneficiaries.
    Because of the lack of available data on which eligible clinicians 
would elect to participate as part of a virtual group under the 
policies finalized in section II.C.4. of this final rule with comment 
period, the scoring model does not reflect the finalized policies for 
scoring virtual groups.
    We estimated the number of newly enrolled Medicare clinicians to be 
excluded from MIPS by assuming clinicians (NPIs) are newly enrolled if 
they have Part B charges in the eligibility file, but no Part B charges 
in 2015. Because of data limitations, this newly enrolled modeling 
methodology is different than the one that will be used under the 
policies finalized under Sec. Sec.  414.1310 and 414.1315.
    To exclude QPs from our scoring model and because the performance 
year 2018 summary was not available at the TIN/NPI level, we used the 
2017 initial QP determination file. We assumed that all partial QPs 
would participate in MIPS and included them in our scoring model. 
Because of the expected growth in Advanced APM participation, the 
estimated number of QPs excluded from our model (an additional 70,732 
clinicians after all other MIPS exclusions have been applied) based on 
data from the 2017 Quality Payment Program performance period is lower 
than the summary level projection for the 2018 Quality Payment Program 
performance period based on the expected growth in APM participation 
(to a total of 185,000-250,000). The 185,000 to 250,000 eligible 
clinicians represent the projected range of QPs for the performance 
year 2018. This expected growth is due in part to the entry of new 
participants in CPC+ and the Next Generation ACO Model for 2018, and 
the Medicare ACO Track 1+ Model which is projected to have a large 
number of participants, with a large majority reaching QP status. 
Hence, our model may overestimate the fraction of clinicians and 
allowed Medicare Part B charges that will remain subject to MIPS after 
the exclusions.
    We have estimated the cumulative effects of these exclusions in 
Table 75.

[[Page 53930]]

We estimate that 66 percent of clinicians' $124,029 million in allowed 
Medicare Part B charges (physician fee schedule services, certain Part 
B drugs, and other non-physician fee schedule services) will be 
included in MIPS. Further, we estimate that approximately 40 percent of 
1,548,022 Medicare clinicians billing to Part B will be included in 
MIPS.
    Table 75 also shows the number of eligible clinicians remaining in 
the scoring model used for this RIA (604,006) is lower than the 
estimated number of eligible clinicians remaining after exclusions 
(621,700). The discrepancy is due to our scoring model excluding 
clinicians that submitted via measures groups under the 2016 PQRS, 
since that data submission mechanism was eliminated under MIPS.

       Table 75--Projected Number of Clinicians Ineligible for or Excluded From MIPS in CY 2018, by Reason
----------------------------------------------------------------------------------------------------------------
                                                     Count of
                                                     Medicare     Part B allowed     Count of
                                                    clinicians       charges *       Medicare     Part B allowed
              Reason for exclusion                  (TIN/NPIs)       remaining      clinicians        charges
                                                     remaining         after        (TIN/NPIs)    excluded ($ in
                                                       after       exclusion ($      excluded        millions)
                                                     exclusion     in millions)
----------------------------------------------------------------------------------------------------------------
All Medicare Clinicians Billing Part B..........       1,548,022        $124,029  ..............  ..............
Subset to clinician types that are eligible for        1,314,733        $101,733         233,289         $22,296
 2020 MIPS payment year **......................
Exclude Newly Enrolled Clinicians ***...........       1,232,779        $101,243          81,954            $490
Additionally, Exclude Low Volume Clinicians ****         692,432         $88,247         540,347         $12,996
Additionally, Exclude Qualifying APM                     621,700         $81,921          70,732          $6,326
 Participants (QPs) *****.......................
    Total remaining in MIPS after exclusions....         621,700         $81,921  ..............  ..............
Percent eligible clinicians remaining in MIPS                40%             66%
 after exclusions...............................
Additional exclusions for scoring model:
    Exclude clinicians who previously submitted          604,006         $73,352          17,694          $8,569
     measures groups under 2016 PQRS............
Percent eligible clinicans remaining in scoring              39%             59%  ..............  ..............
 model after exclusions.........................
----------------------------------------------------------------------------------------------------------------
* Allowed Medicare Part B charges for covered items and services of the clinician under Part B (physician fee
  schedule services, certain Part B drugs, and other non-physician fee schedule services) from September 1, 2015
  to August 31, 2016 data. Payments estimated using 2015 or 2016 dollars.
** Section 1848(q)(1)(C) of the Act defines a MIPS eligible clinician for payment years 1 and 2 as a physician,
  physician's assistant, nurse practitioner, or clinical nurse anesthetist, or a group that includes such
  clinicians.
*** Newly enrolled Medicare clinicians in our scoring model had positive Part B charges between September 1,
  2015 and August 31, 2016 but had no Part B charges for CY2015.
**** Low-volume clinicians have less than or equal to $90,000 in allowed Medicare Part B charges or less than or
  equal to 200 Medicare patients.
***** QPs have at least 25 percent of their Medicare Part B covered professional services or least 20 percent of
  their Medicare beneficiaries furnished part B covered professional services through an Advanced APM. Because
  of the expected growth in Advanced APM participation, the estimated number of QPs excluded from our model (an
  additional 70,732 clinicians after all other MIPS exclusions have been applied) based on data from the 2017
  Quality Payment Program performance period is lower than the summary level projection for the 2018 Quality
  Payment Program performance period based on the expected growth in APM participation (to a total of 185,000-
  250,000).

3. Estimated Impacts on Payments to MIPS Eligible Clinicians
    Our scoring model includes eligible clinicians who will be required 
to submit MIPS data to us in the 2017 MIPS performance period.\49\ They 
are eligible clinicians who (a) are not QPs participating in Advanced 
APMs, (b) exceeded the low volume threshold, and (c) enrolled as 
Medicare clinicians prior to the current performance year.
---------------------------------------------------------------------------

    \49\ Due to data limitations, our scoring model excluded the 
17,694 MIPS eligible clinicians who submitted quality via the 
measures groups mechanism under the 2016 PQRS. The measures group 
submission mechanism is not available in MIPS.
---------------------------------------------------------------------------

    Payment impacts in this final rule with comment period reflect 
averages by specialty and practice size based on Medicare utilization. 
The payment impact for a MIPS eligible clinician could vary from the 
average and would depend on the mix of services that the MIPS eligible 
clinician furnishes. The average percentage change in total revenues 
would be less than the impact displayed here because MIPS eligible 
clinicians generally furnish services to both Medicare and non-Medicare 
patients. In addition, MIPS eligible clinicians may receive Medicare 
revenues for services under other Medicare payment systems, such as the 
Medicare Federally Qualified Health Center Prospective Payment System 
or Medicare Advantage, that would not be affected by MIPS payment 
adjustment factors.
    To estimate the impact of MIPS on clinicians required to report, we 
used the most recently available data, including 2015 and 2016 PQRS 
data, 2014 and 2015 CAHPS for PQRS data, 2014 and 2015 VM data, 2015 
and 2016 Medicare and Medicaid EHR Incentive Program data, the data 
prepared to support the 2017 performance period initial determination 
of clinician and special status eligibility (available via the NPI 
lookup on qpp.cms.gov), the initial QP determination file for the 
transition year, the 2017 MIPS measure benchmarks, and other available 
data to model the scoring provisions described in this regulation. 
First, we arithmetically calculated a hypothetical final score for each 
MIPS eligible clinician based on quality, cost, advancing care 
information, and improvement activities performance categories.
    We estimated the quality performance category score using measures 
submitted to PQRS for the 2016 performance period. For quality measures 
submitted via the claims, EHR, qualified registry, QCDR, and CMS-
approved survey vendor submission mechanisms, we applied the published 
benchmarks developed for the 2017 MIPS performance period. For quality 
measures submitted via Web Interface, we applied the published 
benchmarks developed for the 2016/2017 reporting years for the Shared 
Savings Program where available, and did not calculate scores for 
measures for which Shared Savings Program benchmarks did not exist. As 
mentioned in II.C.6.a.(1) of this final rule with comment period, we 
are finalizing the multiple submission mechanism policy beginning with 
year 3 to allow additional time to communicate how this policy 
intersects with our measure applicability policies. Also, given

[[Page 53931]]

stakeholder concerns regarding our multiple submissions mechanism 
policy, when this policy begins in year 3, we are not requiring that 
MIPS individual clinicians and groups submit via additional submission 
mechanisms, however through this policy the option would be available 
for those that have applicable measures or activities available to 
them. The requirements for the performance categories remain the same 
regardless of the number of submission mechanisms used. We are 
modifying our validation proposal to provide that we will validate the 
availability and applicability of quality measures only with respect to 
the data submission mechanism(s) that a MIPS eligible clinician 
utilizes for the quality performance category for a performance period. 
We will not apply the validation process to any data submission 
mechanism that the MIPS eligible clinician does not utilize for the 
quality performance category for the performance period. We refer 
readers to section II.C.9.c. of this final rule with comment period for 
additional discussion regarding the validation process.
    Because we are not finalizing our proposal to allow multiple 
submission mechanisms within a performance category for the CY 2018 
performance period, we scored the quality performance category score 
based on the measures within each submission mechanism and selected the 
submission mechanism with the highest score. In order to estimate the 
impact of improvement for the quality performance category, we 
estimated a quality performance category percent score using 2015 PQRS 
data, 2014 CAHPS for PQRS data, and 2014 VM data. Because we lack 
detailed information on which MIPS eligible clinicians would elect to 
submit as part of a virtual group, the finalized policy regarding 
virtual groups is not reflected in our scoring model. Our model applied 
the MIPS APM scoring standards in section II.C.6.g. of this final rule 
with comment period to quality data from MIPS eligible clinicians that 
participated in the Shared Savings Program, the Pioneer ACO model, and 
the Next Generation ACO model in 2016.
    We estimated the cost performance category score using measures 
computed for the 2017 value modifier (VM) using data for calendar year 
2015. We used the total per capita cost measure and the Medicare 
Spending Per Beneficiary (MSPB) measure. These VM measures are computed 
for the TIN, so each MIPS eligible clinician was assigned the cost 
performance category score for the applicable TIN. We developed 
benchmarks based on the VM data and assigned between 1 and 10 points 
per measure if the case minimum was met. We required a minimum of 20 
eligible cases for using the total cost per capita score, and a minimum 
of 35 eligible cases for using the Medicare spending per beneficiary 
score. Due to limited data, we did not estimate an improvement score 
for the cost performance category. When the minimum case requirement 
was met for one of these two measures but not the other, we estimated 
the cost performance category score a as the value of the measure that 
had the required number of cases. When the minimum case requirement was 
not met for either measure then we did not estimate a score for the 
cost performance category, and the weight for the cost performance 
category was reassigned to the quality performance quality.
    For the advancing care information performance category score, we 
used data from the CY 2015 and 2016 Medicare and Medicaid EHR Incentive 
Programs. Because the EHR Incentive Programs are based on attestation 
at the NPI level, the advancing care information performance category 
scores are assigned to clinicians by their individual NPI, regardless 
of whether the clinician was part of a group submission for PQRS. We 
assigned a score of 100 percent to MIPS eligible clinicians who 
attested in the 2015 Medicare EHR Incentive Program or received a 2015 
incentive payment from the Medicaid EHR Incentive Program (after 
excluding incentive payments to adopt, implement, and upgrade). While 
we had attestation information for the Medicare EHR Incentive Program, 
we did not have detailed attestation information for the Medicaid EHR 
Incentive Program. Therefore, we used incentive payments (excluding the 
adopt implement and upgrade incentive payments) as a proxy for 
attestation in the Medicaid EHR Incentive Program. Our rationale for 
selecting a 100 percent performance score is that the requirements to 
achieve a base score of 50 percent in MIPS are lower than the EHR 
Incentive Program requirements to attest for meaningful use (which 
determined whether program requirements were met on an all or nothing 
basis). We anticipate clinicians who met EHR Incentive Program 
requirements for meaningful use will be able to achieve an advancing 
care information performance category score of 100 percent. Because the 
minimum requirements for meaningful use did not allow partial scoring, 
we believe the clinicians who met the minimum requirements would be 
able to achieve an advancing care information performance category 
score of 100 percent. For example, the minimum requirements to attest 
to Modified Stage 2 objectives and measures for the 2017 Medicare EHR 
Incentive Program (assuming no measure exceptions and an immunization 
registry is available) would translate into an advancing care 
information performance category score of 85 percent. Generally, we see 
that clinicians have performance greater than the minimum requirements, 
which is the reason we estimated an advancing care information 
performance category score of 100 percent.
    For those clinicians who did not attest in either the 2015 Medicare 
or Medicaid EHR Incentive Program, we evaluated whether the MIPS 
eligible clinician could have their advancing care information 
performance category score reweighted. The advancing care information 
performance category weight is set equal to zero percent, and the 
weight is redistributed to the quality performance category for non-
patient facing clinicians, hospital-based clinicians, ASC-based 
clinicians, NPs, PAs, CRNAs, or CNSs, or those who request and are 
approved for a significant hardship or other type of exception, 
including a new significant hardship exception for small practices, or 
clinicians who are granted an exception based on decertified EHR 
technology. We used the non-patient facing and hospital-based 
indicators and specialty and small practice indicators as calculated in 
the initial MIPS eligibility run. Due to data limitations, we were not 
able to reweight the advancing care information performance category 
scores of ASC-based clinicians in our scoring model. For significant 
hardship exceptions, we used the 2016 final approved significant 
hardship file from the Medicare EHR Incentive Program. If a MIPS 
eligible clinician did not attest and did not qualify for a reweighting 
of their advancing care information performance category, the advancing 
care information performance category score was set equal to zero 
percent. We modeled the improvement activities performance category 
score based on 2016 APM participation and historic participation in 
2016 PQRS and 2016 Medicare and Medicaid EHR Incentive Programs. Our 
model identified 2016 participants in the Shared Savings Program, Next 
Generation ACO Model and the Pioneer ACO Model, and assigned them an 
improvement activity score of 100

[[Page 53932]]

percent, consistent with our policy to assign a 100 percent improvement 
activities score to ACO participants who were not excluded due to being 
QPs. Due to limitations in 2016 data, our model was not able to include 
2016 participants in APMs other than the Shared Savings Program, the 
Pioneer ACO Model, and the Next Generation ACO Model.
    Clinicians and groups not participating in a MIPS APM were assigned 
an improvement activities score based on their performance in the 
quality and advancing care information performance categories. MIPS 
eligible clinicians whose 2016 PQRS data meets all the MIPS quality 
submission criteria (for example, submitting 6 measures with data 
completeness, including one outcome or high priority measures) and had 
an estimated advancing care information performance category score of 
100 percent (if advancing care information is applicable to them) are 
assigned an improvement activities performance category score of 100 
percent. MIPS eligible clinicians who did not participate in 2016 PQRS 
or the 2015 Medicare or Medicaid EHR Incentive Program (if it was 
applicable), earned an improvement activity performance category score 
of zero percent, with the rationale that these clinicians may be less 
likely to participate in MIPS if they have not previously participated 
in other programs.
    For the remaining MIPS eligible clinicians not assigned an 
improvement activities performance category score of 0 or 100 percent 
in our model, we assigned a score that corresponds to submitting one 
medium-weighted improvement activity. The MIPS eligible clinicians 
assigned an improvement activity performance category score 
corresponding to a medium-weighted activity include (a) those who 
submitted some quality measures under the 2016 PQRS but did not meet 
the MIPS quality submission criteria or (b) those who did not submit 
any quality data under the 2016 PQRS who attested under the Medicare 
EHR Incentive program or received an incentive payment (excluding adopt 
implement and upgrade payments) from the Medicaid EHR Incentive 
Program. We assumed that these clinicians may be likely to partially, 
but not fully participate, in the improvement activities category. For 
non-patient facing clinicians, clinicians in a small practice 
(consisting of 15 or fewer professionals), clinicians in practices 
located in a rural area, clinicians in a geographic healthcare 
professional shortage area (HPSA) practice or any combination thereof, 
the medium weighted improvement activity was assigned one-half of the 
total possible improvement activities performance category score (20 
out of a 40 possible points or 50 percent). The remaining MIPS eligible 
clinicians not assigned an improvement activities performance category 
score of 0, 50, or 100 percentage points were assigned a score 
corresponding to one medium-weighted activity (10 out of 40 possible 
points or 25 percent). Due to lack of available data, we were not able 
to identify MIPS eligible clinicians in patient-centered medical homes 
or comparable specialty societies in our scoring model. The policy 
finalized under Sec.  414.1380(b)(3) states that a MIPS eligible 
clinician or group in a practice that is certified as a patient-
centered medical home or comparable specialty practice, as determined 
by the Secretary, receives full credit for performance on the 
improvement activities performance category. In other words, MIPS 
eligible clinicians in a patient centered medical home or comparable 
specialty societies would qualify for an improvement activities 
performance category score of 100 percent.
    Our model assigns a final score for each TIN/NPI by multiplying 
each performance category score by the corresponding performance 
category weight, adding the products together, and multiplying the sum 
by 100 points. For MIPS eligible clinicians that had their advancing 
care information performance category score reweighted due to a 
significant hardship exception or automatic reweighting, the weight for 
the advancing care information performance category was assigned to the 
quality performance category. For MIPS eligible clinicians whose TIN 
did not have a cost performance category score assigned the weight for 
the cost performance category was assigned to the quality performance 
category.
    The scoring model reflects the finalized bonuses for complex 
patients and small practices in sections II.C.7.b.(1)(b) and 
II.C.7.b.(1)(c) of this final rule with comment period. Consistent with 
the policy to define complex patients as those with high medical risk 
or with dual eligibility, our scoring model calculated the bonus by 
using average Hierarchical Condition Category (HCC) risk score, as well 
as the MIPS eligible clinician's patients dual eligible proportion 
calculated for each NPI in the 2015 Physician and Other Supplier Public 
Use File. The dual eligible proportion for each MIPS eligible clinician 
was multiplied by 5. We also generated a group average HCC risk score 
by weighing the scores for individual clinicians in each group by the 
number of beneficiaries they have seen. We generated group dual 
eligible proportions using the weighted average dual eligible patient 
ratio for all MIPS eligible clinicians in the groups, which was then 
multiplied by 5. The complex patient bonus was calculated by adding 
together the average HCC risk score and the ratio of dual eligible 
patients multiplied by 5, with a 5 point cap. Our scoring model also 
adds 5 points to the final score for small practices that had a final 
score greater than 0 points. After adding any applicable bonus for 
complex patients and small practices, we set any final scores that 
exceeded 100 points to equal 100 points.
    We then implemented an exchange function based on the provisions of 
this final rule with comment period to estimate the positive or 
negative MIPS payment adjustment based on the estimated final score and 
the Medicare Part B paid charges. We calculated the parameters of the 
exchange function distributions of MIPS payment adjustments that meet 
statutory requirements related to the linear sliding scale, budget 
neutrality and aggregate exceptional performance payment adjustment 
amounts (as finalized under Sec.  414.1405). Our model used a 15-point 
performance threshold and a 70-point additional performance threshold.
    With the extensive changes to policy and the flexibility that is 
allowed under MIPS, estimating impacts of this final rule with comment 
period using only historic 2016 PQRS participation assumptions would 
significantly overestimate the impact on clinicians, particularly on 
clinicians in practices with 1 to 15 clinicians, which have 
traditionally had lower participation rates. To assess the sensitivity 
of the impact to the participation rate, we have prepared two sets of 
analyses.
    The first analysis, which we label as standard participation 
assumptions, relies on the assumption that a minimum 90 percent of MIPS 
eligible clinicians will participate in submitting quality performance 
category data to MIPS, regardless of practice size. Therefore, we 
assumed that, on average, the categories of practices with 1 to 15 
clinicians would have 90 percent participation in the quality 
performance category. This assumption is an increase from existing 
historical data. PQRS participation rates have increased steadily since 
the program began; the 2015 PQRS Experience Report showed an increase 
in the participation rate from 15 percent in 2007 to 69 percent

[[Page 53933]]

in 2015.\50\ In 2016, among those eligible for MIPS, 93.0 percent 
participated in the PQRS. In 2016, MIPS eligible practices of less than 
1 to 15 clinicians participated in the PQRS at a rate of 70.4 percent. 
Because practices of 16-24 have a 92.6 percent participation rate based 
on historical data, and 25-99 clinicians have a 97.0 percent 
participation rate and practices of 100+ clinicians have a 99.4 percent 
participation rate, we assumed the average participation rates of those 
categories of clinicians would be the same as under the 2016 PQRS. Our 
assumption of 90 percent average participation for the categories of 
practices with 1 to 15 clinicians reflects our belief that small and 
solo practices will respond to the finalized policies and this final 
rule with comment period's flexibility, reduced data submission burden, 
financial incentives, and the support they will receive through 
technical assistance by participating at a rate close to that of other 
practice sizes, enhancing the existing upward trend in quality data 
submission rates. Therefore, we assume that the quality scores assigned 
to new participants reflect the distribution of MIPS quality scores. We 
also applied standard and alternative participation assumptions to the 
improvement activities performance category.
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    \50\ 2015 PQRS Experience Report, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2015_PQRS_Experience_Report.pdf.
---------------------------------------------------------------------------

    To simulate the impact of the standard model assumption, we 
randomly select a subset of non-participants. For each of these non-
participants we substitute the quality score of a randomly selected 
participant, and recompute the improvement activity score to reflect 
the change in quality participation status. For example, for a 
previously non-participating clinician, we substitute the scores of a 
randomly selected MIPS eligible clinician with a quality score of 73 
percent. The improvement activities performance category score is then 
computed using this randomly selected clinician's quality participation 
status. We did not apply the same participation assumptions to the 
advancing care information performance category because the category 
applies only to a subset of MIPS eligible clinicians, and, as noted 
above, would be weighted at zero percent for non-patient facing 
clinicians, hospital-based clinicians, ASC-based clinicians, NPs, PAs, 
CRNAs, or CNSs, and those who request and are approved for a 
significant hardship or other type of exception, including those in 
small practices. Further, we took into account that advancing care 
information performance category participation may be affected by the 
cost and time it may take to acquire and implement certified EHR 
technology needed to perform in that performance category. We did not 
apply the same participation assumptions to the cost performance 
category because the category uses claims data, so participation does 
not require any special action by MIPS eligible clinicians.
    The second analysis, which we label as ``alternative participation 
assumptions,'' assumes a minimum participation rate in the quality 
performance category of 80 percent. In the CY 2018 QPP proposed rule 
[82 FR 30237], we used 2015 PQRS data and in this final rule with 
comment period we updated it with 2016 PQRS data. Because both the 2015 
and 2016 PQRS participation rates for practices of more than 15 
clinicians are greater than 80 percent, this analysis assumes increased 
participation for practices of 1 to 15 clinicians only. Practices of 
more than 15 clinicians are included in the model at their historic 
participation rates.
    Table 76 summarizes the impact on Part B paid amount (physician fee 
schedule services, certain Part B drugs, and other non-physician fee 
schedule services) of MIPS eligible clinicians by specialty for the 
standard participation assumptions.
    Table 77 summarizes the impact on Part B paid amount (physician fee 
schedule services, certain Part B drugs, and other non-physician fee 
schedule services) of MIPS eligible clinicians by specialty under the 
alternative participation assumptions.
    Tables 78 and 79 summarize the impact on Part B paid amount 
(physician fee schedule services, certain Part B drugs, and other non-
physician fee schedule services) of MIPS eligible clinicians by 
practice size for the standard participation assumptions (Table 78) and 
the alternative participation assumptions (Table 79).
    Tables 76 and 78 show that under our standard participation 
assumptions, the vast majority (97.1 percent) of MIPS eligible 
clinicians are anticipated to receive positive or neutral MIPS payment 
adjustments for the 2020 MIPS payment year, with only 2.9 percent 
receiving negative MIPS payment adjustments. Using the alternative 
participation assumptions, Tables 77 and 79 shows that 95.3 percent of 
MIPS eligible clinicians are expected to receive positive or neutral 
payment adjustments.
    The projected distribution of funds reflects this final rule with 
comment period's emphasis on increasing more complete reporting of MIPS 
eligible clinicians for the Quality Payment Program Year 2, which 
continues the ramp to more robust participation in future MIPS 
performance years.
    We chose not to finalize the proposals in the CY 2018 Quality 
Payment Program proposed rule to allow beginning with the 2019 MIPS 
performance period: Implementing facility based measurement (82 FR 
30125) and allowing MIPS eligible clinicians to submit data via 
multiple submission mechanisms (82 FR 30035 through 30036).
    The following policy changes were made between the proposed and 
final rule with comment period that affected our model: The cost 
performance category is weighted at 10 percent not zero percent; the 
multiple submission mechanism policy was not finalized for the 2018 
MIPS performance period; we increased the topped out scoring cap from 6 
points to 7 points and the quality data completeness threshold for 
claims, EHR, QCDR and registry submission mechanisms increased from 50 
percent to 60 percent; and we modified the complex patient bonus by 
increasing the bonus to 5 points and including both HCC risk and dual 
eligible ratio in the bonus. In addition to the policy changes, we 
updated the PQRS information for 2016 which affected the quality score 
and the number of clinicians we estimated participated in group 
reporting and the file used to estimate QP.

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[[Page 53944]]


4. Potential Costs of Compliance With the Advancing Care Information 
and Improvement Activities Performance Categories for Eligible 
Clinicians
a. Potential Costs of Compliance With Advancing Care Information 
Performance Category
    We believe that most MIPS eligible clinicians who can report the 
advancing care information performance category of MIPS have already 
adopted an EHR during Stage 1 and 2 of the Medicare or Medicaid EHR 
Incentive Programs, and will have limited additional operational 
expenses related to compliance with the advancing care information 
performance category requirements. Under the policies established in 
the CY 2017 Quality Payment Program final rule, MIPS eligible 
clinicians who did not participate in the Medicare and Medicaid EHR 
Incentive Programs could potentially have faced additional operational 
expenses for implementation and compliance with the advancing care 
information performance category requirements. We believe that 
clinicians who complied with the transition year requirements of the 
advancing care information performance category will incur no 
additional costs for compliance for this final rule with comment 
period. This final rule with comment period allows clinicians to 
continue to use EHR technology certified to the 2014 Edition CEHRT, 
which would allow them to use the same technology required in the 
transition year. (Clinicians may also choose to use the 2015 Edition 
CEHRT or a combination of the two.) Similarly, we believe that third 
parties who submit data on behalf of clinicians who prepared to submit 
data in the transition year will not incur additional costs as a result 
of this rule.
    As a result of this final rule with comment period, some clinicians 
who were required to submit advancing care information performance 
category data under transition year policies will no longer be required 
to submit data.. As described in section II.C.2.c of this final rule 
with comment period, we found that increasing the low-volume threshold 
to exclude individual eligible clinicians or groups that have Medicare 
Part B allowed charges less than or equal to $90,000 or that provide 
care for 200 or fewer Part B-enrolled Medicare beneficiaries will 
exclude approximately 123,000 additional clinicians from MIPS from the 
approximately 744,000 clinicians that would have been eligible based on 
the low-volume threshold that was finalized in the CY 2017 Quality 
Payment Program final rule. Among the 123,000 additional clinicians 
excluded due to the increase in the low-volume threshold, we estimate 
that approximately 40,000 clinicians who had not previously participate 
in the EHR Incentive Program would have been required to submit 
advancing care information performance category data under the low-
volume threshold finalized in the CY 2017 Quality Payment Program final 
rule.
    In addition to changes to the low volume threshold, we have 
expanded the reasons a clinician can qualify for having the advancing 
care information category be weighted at zero percent of the final 
score. We will continue our policy that was finalized in the 2017 
Quality Payment Program final rule at Sec.  414.1375(a) to reweight the 
advancing care information performance category scores for certain MIPS 
eligible clinicians, including those who may have been exempt from the 
Medicare EHR Incentive Program such as hospital-based clinicians, non-
patient facing clinicians, PAs, NPs, CNs and CRNAs (81 FR 77237 through 
77245). Further, as described in section II.6.f.(7)(a)(iv) of this 
final rule with comment period, we rely on section 1848(o)(2)(D) of the 
Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, 
to assign a scoring weight of zero percent for the advancing care 
information performance category for MIPS eligible clinicians who are 
determined to be based in ambulatory surgical centers (ASCs). As 
described in section II.6.f.(7)(a)(i) of this final rule with comment 
period, we rely on section 1848(o)(2)(D) of the Act, as amended by 
section 4002(b)(1)(B) of the 21st Century Cures Act, to allow MIPS 
eligible clinicians to apply for a significant hardship exception and 
subsequently have their advancing care information performance category 
reweighted to zero when they are faced with a significant hardship. 
Relying on this same authority, we are finalizing a new significant 
hardship exception for the advancing care information performance 
category for MIPS eligible clinicians who are in small practices, as 
discussed in section II.6.f.7.(a)(ii) of this final rule with comment 
period, and finalizing an exception for MIPS eligible clinicians whose 
CEHRT has been decertified under ONC's Health IT Certification Program 
as discussed in section II.6.f.7.(a)(v) of this final rule with comment 
period. While we are unable to account for all of these exceptions in 
our model, we do estimate that approximately 60,000 MIPS eligible 
clinicians in small practices who had not previously reported under the 
EHR Incentive Program would not have to adopt an EHR to comply with the 
advancing care information performance category requirements.
    As we have stated with respect to the Medicare EHR Incentive 
Program, we believe that future retrospective studies on the costs to 
implement an EHR and the return on investment (ROI) will demonstrate 
efficiency improvements that offset the actual costs incurred by MIPS 
eligible clinicians participating in MIPS and specifically in the 
advancing care information performance category, but we are unable to 
quantify those costs and benefits at this time. However, given that 
approximately 40,000 clinicians would no longer be eligible due to the 
low-volume threshold and approximately 60,000 MIPS eligible clinicians 
in small practices qualify for a significant hardship exception, we 
believe the overall cost of compliance would decrease as a result of 
this final rule with comment period.
    At present, evidence on EHR benefits in either improving quality of 
care or reducing health care costs is mixed. This is not surprising 
since the adoption of EHR as a fully functioning part of medical 
practice is progressing, with numerous areas of adoption, use, and 
sophistication demonstrating need for improvement. Even physicians and 
hospitals that can meet Medicare EHR Incentive Program standards have 
not necessarily fully implemented all the functionality of their 
systems or fully exploited the diagnostic, prescribing, and 
coordination of care capabilities that these systems promise. Moreover, 
many of the most important benefits of EHR depend on interoperability 
among systems and this functionality is still lacking in many EHR 
systems.
    A RAND report prepared for the ONC reviewed 236 recent studies that 
related the use of health IT to quality, safety, and efficacy in 
ambulatory and non-ambulatory care settings and found that--
    ``A majority of studies that evaluated the effects of health IT on 
healthcare quality, safety, and efficiency reported findings that were 
at least partially positive. These studies evaluated several forms of 
health IT: Metric of satisfaction, care process, and cost and health 
outcomes across many different care settings. Our findings agree with 
previous [research] suggesting that health IT, particularly those 
functionalities included in the Medicare EHR Incentive Program 
regulation, can improve healthcare quality and safety. The relationship 
between health IT and [health care] efficiency is complex and remains 
poorly documented or understood, particularly in terms of

[[Page 53945]]

healthcare costs, which are highly dependent upon the care delivery and 
financial context in which the technology is implemented.'' \51\ Other 
recent studies have not found definitive quantitative evidence of 
benefits.\52\ Health IT vendors may face additional costs in Quality 
Payment Program Year 2 if they choose to develop additional 
capabilities in their systems to submit advancing care information and 
improvement activities performance category data on behalf of MIPS 
eligible clinicians.
---------------------------------------------------------------------------

    \51\ Paul G. Shekelle, et al. Health Information Technology: An 
Updated Systematic Review with a Focus on Meaningful Use 
Functionalities. RAND Corporation. 2014.
    \52\ See, for example, Saurabh Rahurkar, et al., ``Despite the 
Spread of Health Information Exchange, There Is Little Information 
of Its Impact On Cost, Use, And Quality of Care,'' Health Affairs, 
March 2015; and Hemant K. Bharga and Abhay Nath Mishra, ``Electronic 
Medical Records and Physician Productivity: Evidence from Panel Data 
Analysis,'' Management Science, July 2014.
---------------------------------------------------------------------------

    We requested comments that provide information that would enable us 
to quantify the costs, costs savings, and benefits associated with 
implementation and compliance with the requirements of the advancing 
care information performance category.
    The following is a summary of the public comments received 
regarding information that would enable us to quantify the costs, costs 
savings, and benefits associated with implementation and compliance 
with the requirements of the advancing care information performance 
category and our responses:
    Comment: Several commenters indicated that CEHRT compliance, 
changing EHR systems, or switching from the 2014 CEHRT Edition to the 
2015 CEHRT Edition remains costly for many small groups and individual 
clinicians. We received one comment that quantified the cost of 
compliance with the advancing care information performance category. 
One commenter mentioned they may be forced to change to another 
software, at a minimum cost of $90,000. The commenter noted risks of 
losing data in the process of conversion, and that none of the EHRs the 
commenter has tried has the same ease of use as the software they have 
been using for 11 years.
    Response: Because we received only one comment that quantified the 
cost of compliance with the advancing care information performance 
category, we do not have sufficient information to draw robust 
conclusions about the cost of compliance for all types of practices, 
therefore we are not adding more quantified costs. As discussed in 
section II.C.6.f.(4), we are not requiring clinicians to upgrade to the 
2015 Edition CEHRT for the 2018 MIPS performance period, but we 
continue to believe that 2015 Edition products have other benefits such 
as the ability to better support interoperability across the care 
continuum.
    Final Action: After consideration of public comments, on the cost 
of compliance with the advancing care information category, we are not 
quantifying the costs, costs savings, and benefits associated with 
implementation and compliance with the requirements of the advancing 
care information performance category. However, given that 
approximately 40,000 clinicians would no longer be eligible due to the 
low-volume threshold and approximately 60,000 MIPS eligible clinicians 
in small practices qualify for a significant hardship exception, we 
believe the overall potential cost of compliance would decrease as a 
result of this final rule with comment period.
b. Potential Costs of Compliance With Improvement Activities 
Performance Category
    Under the policies established in the CY 2017 Quality Payment 
Program final rule, the costs for complying with the improvement 
activities performance category requirements could have potentially led 
to higher expenses for MIPS eligible clinicians. Costs per full-time 
equivalent primary care clinician for improvement activities will vary 
across practices, including for some activities or certified patient-
centered medical home practices, in incremental costs per encounter, 
and in estimated costs per (patient) member per month.
    Costs for compliance with transition year policies may vary based 
on panel size (number of patients assigned to each care team) and 
location of practice among other variables. For example, Magill (2015) 
conducted a study of certified patient-centered medical home practices 
in two states.\53\ That study found that costs associated with a full-
time equivalent primary care clinician, who were associated with 
certified patient-centered medical home practices, varied across 
practices. Specifically, the study found an average cost of $7,691 per 
month in Utah practices, and an average of $9,658 in Colorado 
practices. Consequently, incremental costs per encounter were $32.71 
for certified patient-centered medical home practices in Utah and 
$36.68 in Colorado (Magill, 2015). The study also found that the 
average estimated cost per patient member, per month, for an assumed 
panel of 2,000 patients was $3.85 in Utah and $4.83 in Colorado. 
However, given the lack of comprehensive historical data for 
improvement activities, we are unable to quantify those costs in detail 
at this time.
---------------------------------------------------------------------------

    \53\ Magill et al. ``The Cost of Sustaining a Patient-Centered 
Medical Home: Experience from 2 States.'' Annals of Family Medicine, 
2015; 13:429-435.
---------------------------------------------------------------------------

    The following factors also contribute to the difficulty of 
identifying compliance costs for the improvement activities performance 
category. Some improvement activities, such as those related to 
expanded hours and access (for example, IA_EPA_1 ``Provide 24/7 Access 
to Eligible Clinicians or Groups Who Have Real-time Access to Patient's 
Medical Record'' as finalized in Table G of the appendices of this 
final rule with comment period), may be revenue neutral as MIPS 
eligible clinicians can receive payment for services provided during 
the expanded hours. Other improvement activities, such as IA_PSPA_2 
``Participation in MOC Part IV'' (as finalized in Table G of the 
appendices of this final rule with comment period), is connected to 
board certification, and we anticipate that there would be no 
additional compliance costs associated with this final rule with 
comment period above and beyond costs that clinicians already incur to 
maintain board certification. Some improvement activities have direct 
out-of-pocket costs, such as fees, while other improvement activities 
have no fees.
    While we are unable to quantify the compliance costs of the 
improvement activities performance category, we do believe that because 
we are increasing the low volume threshold (as described in section 
II.C.2.c of this final rule with comment period), we will exclude 
approximately 123,000 additional clinicians from MIPS from the 
approximately 744,000 clinicians that would have been eligible based on 
the low-volume threshold that was finalized in the CY 2017 Quality 
Payment Program final rule. With this reduction in clinicians that are 
required to submit data to the improvement activities performance 
category, we believe the overall potential cost of compliance would 
decrease as a result of this final rule with comment period.
    Further, we anticipate that the vast majority of clinicians 
submitting improvement activities data to comply with transition year 
policies could continue to submit the same activities under the 
policies established in this final year with comment period. Only 1 of 
the 92 improvement activities established in the transition year was 
removed from the inventory, while 20 additional activities were added 
(See

[[Page 53946]]

Tables F and G of the Appendices). Similarly, we believe that third 
parties who submit data on behalf of clinicians who prepared to submit 
data in the transition year will not incur additional costs as a result 
of this rule. We requested comments that provide information that would 
enable us to quantify the costs, costs savings, and benefits associated 
implementation of improvement activities.
    The following is a summary of the public comments received and our 
responses:
    Comment: A few commenters urged CMS to consider the regulatory 
impact on both clinicians and vendors in documenting and demonstrating 
successful performance of improvement activities. One commenter asked 
that CMS consider the direct costs charged by vendors for submitting 
improvement activities via qualified registry and/or EHR, which can be 
substantial as reflected in the updated qualified registries and QCDR 
lists for performance period 2017. One commenter suggested that CMS 
determine and publish the organizational costs (for both clinical 
organizations and vendors) to meet Quality Payment Program requirements 
to make the opportunity costs of the Quality Payment Program more 
apparent, because the commenter believed these costs displace 
discretionary spending on bona fide improvement activities in terms of 
money, time, and personnel.
    Response: Improvement activities are an opportunity for clinicians 
to engage in activities that are most relevant to their practice and 
contribute toward improvements in health outcomes. As such, we believe 
the effort needed to demonstrate successful performance will be limited 
as the clinicians will be reporting on improvement activities that they 
are already performing because they recognize health outcome 
improvements. Additionally, activities may be continuing (that is, 
could have started prior to the performance period and are continuing) 
or be adopted in the performance period as long as an activity is being 
performed for at least 90 days. This means that clinicians may have 
already invested in implementing an improvement activity in CY 2017 and 
may be continuing with that activity in CY 2018 where they are not 
incurring any additional costs. For consideration of the direct costs 
charged by vendors, we believe the commenter is referring to the 2017 
lists available at https://qpp.cms.gov/docs/QPP_2017_Qualified_Registries.pdf and https://qpp.cms.gov/docs/QPP_2017_CMS_Approved_QCDRs.pdf. While the costs vary on these lists, 
we note that we are unable to estimate the average costs per clinician. 
As stated in our description above, costs may vary based on panel size 
and location of practice among other variables. As such, we thank 
commenters for their input and will take them into consideration as we 
continue to evaluate how best to quantify the costs, costs savings, and 
benefits associated implementation of improvement activities.
    Final Action: We will take into consideration of public comments 
received regarding the costs of implementation of improvement 
activities. We are not quantifying the costs, costs savings, and 
benefits associated with implementation and compliance with the 
requirements of the information activities performance category because 
we cannot systematically determine the amount associated with the 
regulation compliance at this time. However, with the reduction in 
clinicians that are required to submit data to the improvement 
activities performance category due to changes in the low-volume 
threshold, we believe the overall potential cost of compliance would 
decrease as a result of this final rule with comment period.

D. Impact on Beneficiaries

    There were a number of changes in this final rule with comment 
period that will have an effect on beneficiaries. In general, we 
believe that the changes may have a positive impact and improve the 
quality and value of care provided to Medicare beneficiaries. More 
broadly, we expect that over time clinician engagement in the Quality 
Payment Program may result in improved quality of patient care, 
resulting in lower morbidity and mortality. We believe the policies 
finalized in the CY 2017 Quality Payment Program final rule, as well as 
policies in this rule will lead to additional growth in the 
participation of both MIPS APMS and Advanced APMs. APMs promote 
seamless integration by way of their payment methodology and design 
that incentivize such care coordination. The policies that are being 
finalized regarding the All-Payer Combination Option and identification 
of Other Payer Advanced APMs will help facilitate both the development 
and participation in alternative payment arrangements in the private 
and public sectors. Beginning in Quality Payment Program Year 3, the 
All-Payer Combination Option will be an available pathway to QP status 
for eligible clinicians participating sufficiently in Advanced APMs and 
Other Payer Advanced APMs. The All-Payer Combination Option allows for 
eligible clinicians to achieve QP status through their participation in 
both Advanced APMs and Other Payer Advanced APMs. Clinicians can focus 
their efforts around the care transformation in either Advanced APM or 
MIPS APM models and know that those efforts will be aligned with the 
Quality Payment Program, either through incentive payments for QPs or 
through MIPS scores calculated based on performance within the APM 
assessed at the APM Entity level.
    Several Advanced APMs and MIPS APMS have shown evidence of 
improving the quality of care provided to beneficiaries and 
beneficiaries' experience of care. For example, in August of 2015, we 
issued quality and financial performance results for 2014 showing that 
ACOs continue to improve the quality of care for Medicare beneficiaries 
while generating net savings to the Medicare trust fund, if shared 
savings paid out to these ACOs are not included.\54\ In 2014, the 20 
ACOs in the Pioneer ACO Model and 333 Shared Shavings Program ACOs 
generated more than $411 million in total savings, which includes all 
ACOs' savings and losses but does not include shared savings payments 
to ACOs. The Pioneer ACO Model achieved net savings even after paying 
out shared savings payments to ACOs. Additionally, in their first years 
of implementation, both Pioneer and Shared Savings Program ACOs had 
higher quality care than Medicare FFS providers on measures for which 
comparable data were available. Beneficiaries with multiple chronic 
conditions and high predicted Medicare spending that were assigned to 
Shared Savings Program ACOs received better quality care than 
comparable FFS beneficiaries.\55\ Between the first and fourth 
performance years of the Pioneer ACO Model, Pioneer ACOs improved their 
average quality score from 71 percent to 92 percent.
---------------------------------------------------------------------------

    \54\ https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Factsheets-items/2015-08-25.html.
    \55\ J.M. McWilliams et al., ``Changes in Patients' Experiences 
in Medicare Accountable Care Organizations.'' New England Journal of 
Medicine 2014; 371:1715-1724, DOI: 10.1056/NEJMsa1406552.
---------------------------------------------------------------------------

    The results from the third program year (January through December 
2015) of the original CPC Initiative indicate that from 2013 to 2015 
CPC practices transformed their care delivery--with the biggest 
improvements in risk-stratified care management, expanded access to 
care, and continuity of care. The independent evaluation also found

[[Page 53947]]

that CPC also improved patient experience slightly. Over the first 3 
years, ED visits increased by 2 percent less for Medicare FFS 
beneficiaries in CPC practices relative to those in comparison 
practices.56 57
---------------------------------------------------------------------------

    \56\ Peikes, D., Taylor, E., Dale, S., et al. ``Evaluation of 
the Comprehensive Primary Care Initiative: Second Annual Report.'' 
Princeton, NJ: Mathematica Policy Research, April 13, 2016, 
available at https://innovation.cms.gov/files/reports/cpci-evalrpt2.pdf.
    \57\ For more detail see Peikes, D., Anglin, G., Taylor, E., et 
al. ``Evaluation of the Comprehensive Primary Care Initiative: Third 
Annual Report.'' Princeton, NJ: Mathematica Policy Research, 
December 2016, available at https://innovation.cms.gov/Files/reports/cpci-evalrpt3.pdf.
---------------------------------------------------------------------------

    As the early findings from the original CPC initiative and 
literature from other medical home models supported by payment suggest, 
we expect to see improvement in quality and patient experience of 
care.58 59 60 61 Under CPC+, a higher proportion of the 
practice revenue is de-linked from FFS payment and there is thus more 
flexibility for practices to deliver care without a face-to-face 
encounter and instead in the modality that best meets patients' health 
care needs (that is, office visit, virtual visit, phone call, 
etc.).\62\
---------------------------------------------------------------------------

    \58\ Reid, R.J., Fishman, P.A., Yu, O., Ross, T.R., Tufano, 
J.T., Soman, M.P, & Larson, E.B. (2009). Patient-centered medical 
home demonstration: A prospective, quasi-experimental, before and 
after evaluation. AJMC, 15(9), e71-e87.
    \59\ Maeng, D.D., Graham, J., Graf, T.R., Liberman, J.N., 
Dermes, N.B., Tomcavage, J., et al (2012). Reducing long-term cost 
by transforming primary care: Evidence from Geisinger's Medical Home 
Model. AJMC, 18(3), 149-155.
    \60\ Nelson, K.M., Helfrich, C., Sun, H., Hebert, P.L., Liu, 
C.F., Dolan, E., et al. (2014). Implementation of the patient-
centered medical home in the Veterans Health Administration: 
Associations with patient satisfaction, quality of care, staff 
burnout, and hospital and emergency department use. JAMA Intern Med, 
174(8), 1350-1358.
    \61\ DeVries, A., Li, C.H.W., Sridhar, G., Hummel, J.R., 
Breidbart, S., & Barron, J.J. (2012). Impact of medical homes on 
quality, Healthcare utilization, and costs. AJMC, 18(9), 534-544.
    \62\ Mechanic, R.E., Santos, P., Landon, B.E., & Chernew, M.E. 
(2011). Medical group responses to global payment: early lessons 
from the `Alternative Quality Contract' in Massachusetts. Health Aff 
(Millwood), 30(9), 1734-42.
---------------------------------------------------------------------------

    While maintaining coverage of Original Medicare services and 
beneficiary freedom to choose providers, ACOs could potentially enhance 
care management of the chronically ill aligned population through the 
adoption of leading-edge technologies, care coordination techniques, 
and evidence-based benefit enhancements that motivate providers and 
beneficiaries to optimize care. The evidence discussed here focuses on 
the benefit enhancements available under the Next Generation ACO Model, 
which include enhanced telehealth and home health care.
    The transition from the inpatient setting to home is a critical 
period for patients, particularly elderly populations. Studies have 
examined a variety of interventions to help smooth care transitions. 
Interventions found in the literature include advance practice nurse-
led comprehensive discharge planning and home visit follow-up 
protocols\63,64,65\ and patient coaching accompanied by post-discharge 
home visits.\66\ The Next Generation ACO Model is testing whether 
allowing participating ACOs to furnish and bill for types of post-
discharge home visits not currently available under Original Medicare 
would improve outcomes for beneficiaries assigned to the ACO.
---------------------------------------------------------------------------

    \63\ Naylor MD, Brooten D, Campbell R, et al. Comprehensive 
Discharge Planning and Home Follow-up of Hospitalized Elders: A 
Randomized Clinical Trial. JAMA. 1999;281(7):613-620.
    \64\ Naylor, M. D., Brooten, D. A., Campbell, R. L., Maislin, 
G., McCauley, K. M. and Schwartz, J. S. (2004), Transitional Care of 
Older Adults Hospitalized with Heart Failure: A Randomized, 
Controlled Trial. Journal of the American Geriatrics Society, 52: 
675-684.
    \65\ Stauffer BD, Fullerton C, Fleming N, et al. Effectiveness 
and Cost of a Transitional Care Program for Heart Failure: A 
Prospective Study with Concurrent Controls. Arch Intern Med. 
2011;171(14):1238-1243.
    \66\ Voss R, Gardner R, Baier R, Butterfield K, Lehrman S, 
Gravenstein S. The Care Transitions Intervention: Translating From 
Efficacy to Effectiveness. Arch Intern Med. 2011;171(14):1232-1237.
---------------------------------------------------------------------------

    The study of the potential value and efficacy of telehealth and 
remote patient monitoring has become more prevalent in recent years as 
technology has enabled greater utilization of these services.\67\ 
Studies and case studies from health systems have shown value in using 
telehealth platforms for activities such as e-visits 68 69 
and remote patient monitoring,\70\ as well as for higher intensity care 
through real-time videoconferencing,\71\ particularly to enable older 
adults to receive care more rapidly from their homes and with minimal 
burden. The Next Generation ACO Model allows ACOs flexibility in 
utilizing telehealth services to improve access to the most appropriate 
care for aligned beneficiaries.
---------------------------------------------------------------------------

    \67\ Joseph Kvedar, Molly Joel Coye and Wendy Everett, Connected 
Health: A Review Of Technologies and Strategies to Improve Patient 
Care with Telemedicine and Telehealth, Health Affairs, 33, no.2 
(2014):194-199.
    \68\ Patrick T. Courneya, Kevin J. Palattao and Jason M. 
Gallagher. HealthPartners' Online Clinic For Simple Conditions 
Delivers Savings Of $88 Per Episode And High Patient Approval. 
Health Affairs, 32, no.2 (2013):385-392.
    \69\ Mehrotra A, Paone S, Martich G, Albert SM, Shevchik GJ. A 
Comparison of Care at E-visits and Physician Office Visits for 
Sinusitis and Urinary Tract Infection. JAMA Intern Med. 
2013;173(1):72-74.
    \70\ UVA Health System, Tech Firm Collaborate to Reduce Hospital 
Readmission Rates. VHQC News. June 2014.
    \71\ Shah MN, Gillespie SM, et al. High-Intensity Telemedicine-
Enhanced Acute Care for Older Adults: An Innovative Healthcare 
Delivery Model. Journal of the American Geriatrics Society. 2003; 
61(11):2000-2007.
---------------------------------------------------------------------------

1. Impact on Other Health Care Programs and Providers
    We estimate that the Quality Payment Program Year 2 will not have a 
significant economic effect on eligible clinicians and groups and 
believe that MIPS policies, along with increasing participation in APMs 
over time may succeed in improving quality and reducing costs. This may 
in turn result in beneficial effects on both patients and some 
clinicians, and we intend to continue focusing on clinician-driven, 
patient-centered care.
    We will implement several policies for the Quality Payment Program 
Year 2 to reduce burden. These include raising the low-volume threshold 
with the effect that fewer clinicians in small practices are required 
to participate in the MIPS starting with the 2018 MIPS performance 
period; including bonus points for clinicians in small practices; 
adding a new significant hardship exception for the advancing care 
information performance category for MIPS eligible clinicians in small 
practices; implementing virtual groups; and extending the ability of 
MIPS eligible clinicians and groups to use 2014 CEHRT Edition while 
providing bonus points for the use of the 2015 Edition of CEHRT. 
Additionally, for vendors, we believe the flexibility to use EHR 
technology certified to either the 2014 Edition or the 2015 Edition for 
the Quality Payment Program Year 2 is beneficial as vendors will have 
additional time to deploy the updated software to their customers, 
which are the clinicians and other providers. Clinicians will likewise 
have additional time to upgrade and implement the new functionalities.
    In summary, the Quality Payment Program policies are designed to 
promote the delivery of high-value care for individuals in all 
practices and areas with a focus on easing the burden for clinicians in 
small and solo practices. We believe each of these policies will 
further reduce burdens on clinicians and practices and help increase 
successful participation. Further, the policies throughout this final 
rule with comment period will focus the Quality Payment Program in its 
second year on encouraging more complete data submission and educating 
clinicians. The policies will continue a glide path, which began in the 
transition year, to more robust participation and performance in future 
years. The policy

[[Page 53948]]

changes are reflected in the RIA estimates, which show that the risk 
for negative MIPS payment adjustment is minimal for MIPS eligible 
clinicians, including small and solo practices that meet the data 
completeness requirements.
2. Alternatives Considered
    This final rule with comment period contains a range of policies, 
including many related to specific statutory provisions. The preceding 
preamble provides descriptions of the statutory provisions that are 
addressed, identifies those policies where discretion has been 
exercised, presents our rationale for our policies and, where relevant, 
analyzes alternatives that we considered. We view the performance 
threshold as one of the most important factors affecting the 
distribution of payment adjustments under the Quality Payment Program, 
and the alternatives that we considered focus on that policy.
    For example, as discussed in section II.C.8.c. of this final rule 
with comment period, we finalized a 15-point performance threshold and 
a 70-point additional performance threshold. As described earlier, we 
assumed a minimum 90 percent participation rate in each category of 
eligible clinicians and an alternative with a minimum 80 percent 
participation rate. We displayed the results of that modeling in Table 
76 and 77 along with subsequent tables described in section VI.B.2 of 
this final rule with comment period.
    In addition, as discussed in section II.C.2.c, we increased the 
low-volume threshold to exclude individual eligible clinicians or 
groups that have Medicare Part B allowed charges less than or equal to 
$90,000 or that provide care for 200 or fewer Part B-enrolled Medicare 
beneficiaries compared to the low-volume threshold that was finalized 
in the CY 2017 Quality Payment Program final rule which would exclude 
individual eligible clinicians or groups that have Medicare Part B 
allowed charges less than or equal to $30,000 or that provide care for 
100 or fewer Part B-enrolled Medicare beneficiaries. Using our standard 
model assumptions described in section VI.C.3 of this final rule with 
comment period, the low volume threshold based on the transition year 
would have included approximately 744,000 MIPS eligible clinicians 
distribute approximately $139 million in payment adjustments on a 
budget-neutral basis, compared to our final policy which has 622,000 
MIPS eligible clinicians and distributes approximately $118 million in 
payment adjustments on a budget-neutral basis.
3. Assumptions and Limitations
    We would like to note several limitations to the analyses that 
estimated MIPS eligible clinicians' eligibility, negative MIPS payment 
adjustments, and positive payment adjustments for the 2020 MIPS payment 
year based on the data prepared to support the 2017 performance period 
initial determination of clinician and special status eligibility 
(available via the NPI lookup on qpp.cms.gov), participant lists using 
the initial QP determination file for the transition year, and 2014, 
2015, and 2016 data from legacy programs, including the PQRS, CAHPS for 
PQRS, and the VM.
    The scoring model cannot fully reflect MIPS eligible clinicians' 
behavioral responses to MIPS. The scoring model assumes higher 
participation in MIPS quality reporting than under the PQRS. Other 
potential behavioral responses are not addressed in our scoring model. 
The scoring model assumes that quality measures submitted and the 
distribution of scores on those measures would be similar under Quality 
Payment Program Payment in the 2020 MIPS payment year as they were 
under the 2016 PQRS program.
    The scoring model does not reflect the growth in Advanced APM 
participation between 2017 and 2018 (Quality Payment Program Years 1 
and 2). After applying the other MIPS exclusions, the scoring model 
excluded an additional 70,732 QPs using the initial QP determination 
file.\72\ This estimate is much lower than the summary level projection 
for the 2018 Quality Payment Program performance period based on the 
total expected growth in APM participation (185,000 to 250,000) because 
the projected file does not have information at the TIN/NPI level which 
is needed for our model.
---------------------------------------------------------------------------

    \72\ 70,732 QPs were excluded from our analysis who did not meet 
any of the other MIPS exclusion or ineligibility criteria; in other 
words, they were eligible clinician types and exceeded the low-
volume threshold. An additional 29,917 QPs were excluded from our 
burden estimates who also met other MIPS exclusion or ineligibility 
criteria--that is they were not eligible clinician types or did not 
exceed the low-volume threshold.
---------------------------------------------------------------------------

    There are additional limitations to our estimates. To the extent 
that there are year-to-year changes in the data submission, volume and 
mix of services provided by MIPS eligible clinicians, the actual impact 
on total Medicare revenues will be different from those shown in Tables 
76 through 79. Due the limitations above, there is considerable 
uncertainty around our estimates that is difficult to quantify in 
detail.

E. Regulatory Review Costs

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this final rule with 
comment period, we should estimate the cost associated with regulatory 
review. Due to the uncertainty involved with accurately quantifying the 
number of entities that will review this final rule with comment 
period, we assume that the total number of commenters on the CY 2018 
Quality Payment Program published proposed rule will be the number of 
reviewers of this final rule with comment period (1300 commenters). We 
acknowledge that this assumption may understate or overstate the costs 
of reviewing this rule. It is possible that not all commenters reviewed 
the proposed in detail, and it is also possible that some reviewers 
chose not to comment on the CY 2018 Quality Payment Program proposed 
rule. For these reasons, we believe that the number of commenters for 
the CY 2018 Quality Payment Program proposed rule would be a fair 
estimate of the number of reviewers of this final rule with comment 
period.
    We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of this final rule with 
comment period. Therefore, for the purposes of our estimate, we assume 
that each reviewer reads approximately 50 percent of the final rule 
with comment period.
    Using the wage information from the BLS for practice administrators 
(medical and health service managers) (Code 11-9111), we estimate that 
the cost of reviewing the proposed rule is $105.16 per hour, including 
overhead and fringe benefits, which we assume are 100 percent of the 
hourly wage for a practice administrator (https://www.bls.gov/oes/2016/may/naics4_621100.htm). Assuming an average reading speed, we estimate 
that it would take approximately 16.4 hours for a practice 
administrator to review half of the proposed rule. For each commenter 
that reviews this final rule with comment period, the estimated cost is 
$1,724.62 (16.4 hours x $105.16). Therefore, we estimate that the total 
cost of reviewing this final rule with comment period is $2,242,011.20 
($1,724.62 x 1,300 reviewers).
    We welcomed any public comments on the approach in estimating the 
number of entities that would review the regulatory text that we 
described in CY 2018 Quality Payment Program proposed rule (82 FR 
30244). We did not receive any specific comments related to the number 
of readers of this proposed rule, or that each reviewer

[[Page 53949]]

reads approximately 50 percent of the information.

F. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Table 80 (Accounting 
Statement), we have prepared an accounting statement.
    We have not attempted to quantify the benefits of this final rule 
with comment period because of the many uncertainties as to both 
clinician behaviors and resulting effects on patient health and cost 
reductions. For example, the applicable percentage for MIPS payment 
adjustments changes over time, increasing from 4 percent in 2019 to 9 
percent in 2022 and subsequent years, and we are unable to estimate 
precisely how physicians will respond to the increasing payment 
adjustments. As noted above, in CY 2020, we estimate that we will 
distribute approximately $118 million in payment adjustments on a 
budget-neutral basis, which represents the applicable percent for 2020 
required under section 1848(q)(6)(B)(i) of the Act and excludes $500 
million in additional MIPS payment adjustments for exceptional 
performance.
    Further, the addition of new Advanced APMs and growth in Advanced 
APM participation over time will affect the pool of MIPS eligible 
clinicians, and for those that are MIPS eligible clinicians, may change 
their relative performance. The $500 million available for exceptional 
performance and the 5 percent APM Incentive Payment for QPs are only 
available from 2019 through 2024. Beginning in 2026, Medicare PFS 
payment rates for services furnished by QPs will receive a higher 
update than for services furnished by non-QPs. However, we are unable 
to estimate the number of QPs in those years, as we cannot project the 
number or types of Advanced APMs that will be made available in those 
years through future CMS initiatives proposed and implemented in those 
years, nor the number of QPs for those future Advanced APMs.
    The percentage of the final score attributable to each performance 
category will change over time and we will continue to refine our 
scoring rules. The improvement activities category represents a new 
category for measuring MIPS eligible clinicians' performance. We may 
also propose policy changes in future years as we continue implementing 
MIPS and as MIPS eligible clinicians accumulate experience with the new 
system. Moreover, there are interactions between the MIPS and APM 
incentive programs and other shared savings and incentive programs that 
we cannot model or project. Nonetheless, even if ultimate savings and 
health benefits represent only low fractions of current experience, 
benefits are likely to be substantial in overall magnitude.
    Table 80 includes our estimate for MIPS payment adjustments ($118 
million), the exceptional performance payment adjustments under MIPS 
($500 million), and incentive payments to QPs (using the range 
described in the preceding analysis, approximately $675-$900 million). 
However, of these 3 elements, only the negative MIPS payment 
adjustments are shown as estimated decreases.

                Table 80--Accounting Statement: Transfers
------------------------------------------------------------------------
                Category                            Transfers
------------------------------------------------------------------------
CY 2020 Annualized Monetized Transfers.  Estimated increase of between
                                          $1,293 and $1,518 million in
                                          payments for higher
                                          performance under MIPS and to
                                          QPs.\73\
From Whom to Whom?.....................  Increased Federal Government
                                          payments to physicians, other
                                          practitioners and suppliers
                                          who receive payment under the
                                          Medicare Physician Fee
                                          Schedule.
------------------------------------------------------------------------
Category                                 Transfers
------------------------------------------------------------------------
CY 2020 Annualized Monetized Transfers.  Estimated decrease of $118
                                          million for lower performance
                                          under MIPS.
From Whom to Whom?.....................  Reduced Federal Government
                                          payments to physicians, other
                                          practitioners and suppliers
                                          who receive payment under the
                                          Medicare Physician Fee
                                          Schedule.
------------------------------------------------------------------------
Note: These estimates are identical under both a 7 percent and 3 percent
  discount rate.

    Based on National Health Expenditure data,\74\ total Medicare 
expenditures for physician and clinical services in 2015 reached $144.3 
billion. Expenditures for physician and clinical services from all 
sources reached $634.9 billion. Table 80 shows that the aggregate 
negative MIPS payment adjustment for all MIPS eligible clinicians under 
MIPS is estimated at $118 million, which represents approximately 0.08 
percent of Medicare payments for physician and clinical services and 
approximately 0.02 percent of payments for physician and clinician 
services from all sources. Table 80 also shows that the aggregate 
positive payment adjustment for MIPS eligible clinicians under MIPS is 
estimated at $618 million (including additional MIPS payment 
adjustments for exceptional performance), which represents less than 
0.5 percent of Medicare expenditures for physician and clinician 
services and 0.1 percent of Medicare expenditures from all sources for 
physician and clinical services.
---------------------------------------------------------------------------

    \73\ A range of estimates is provided due to uncertainty about 
the number of Advanced APM participants that will meet the QP 
threshold in 2016.
    \74\ Physicians and Clinical Services Expenditures, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsHistorical.html.
---------------------------------------------------------------------------

    Table 81 summarizes the regulatory review costs discussed in 
section VI.E. of this final rule with comment period, and the 
collection of information burden costs calculated in section IV.N. of 
this final rule with comment period.
    As noted above, we estimate the regulatory review costs of $2.2 
million for this final rule with comment period. In Table 81, we have 
prepared our analysis of collection of information burden costs to be 
consistent with guidance in accordance with OMB's April 2017 guidance 
on EO13771. The Order's guidance directs agencies to measure certain 
costs, including costs associated with ``Medicare quality performance 
tracking'', using the estimates in the CY 2017 Quality Payment Program 
final rule as a baseline. The Order notes that regular updates to 
certain Medicare regulations make assessments of the incremental 
changes related to ``performance tracking'' included in a regulation 
much more useful than a comparison against

[[Page 53950]]

hypotheticals (such as a program's hypothetical discontinuation).
    As shown in section IV.N. of this final rule with comment period, 
we estimate that this final rule with comment period will result in 
approximately $695 million in collection of information-related burden. 
However, we estimate that the incremental collection of information-
related burden associated with this final rule with comment period is 
an approximately $13.9 million reduction relative to the baseline 
burden of continuing the policies and information collections set forth 
in the CY 2017 Quality Program final rule into CY 2018. Our burden 
estimates reflect several finalized policies that would reduce burden, 
including the reduction in the length of the CAHPS survey; and our 
proposal to allow MIPS eligible clinicians to form virtual groups, 
which would create efficiencies in data submission; and our proposal 
for significant hardship or other type of exception, including a new 
significant hardship exception for small practices for the advancing 
care information performance category.

                 Table 81--Additional Costs and Benefits
------------------------------------------------------------------------
      Category of cost or benefits                Costs/benefits
------------------------------------------------------------------------
Regulatory Review Costs................  $2.2 million.
Incremental Collection of Information/   -$13.9 million.
 Paperwork Reduction Act Burden
 Estimates.
Costs of Newly Incentivized EHR and      Unquantified reduction due to a
 Improvement Activities.                  reduction of clinicians
                                          required to submit data, but
                                          potentially anticipated.
Benefits of Expanded Advanced and MIPS   Improvements in quality,
 APM Participation.                       patient experience of care,
                                          readmission rates, access to
                                          appropriate care, and total
                                          cost of care.
Benefits of MIPS.......................  Improvements in quality,
                                          patient experience of care,
                                          and readmission rates.
------------------------------------------------------------------------
Note: These estimates are identical under both a 7 percent and 3 percent
  discount rate. Incremental information collection costs are total
  information collection costs associated with this final rule with
  comment period minus costs associated with CY 2017 Quality Payment
  Program final rule.

    Table 81 also shows the expected benefits associated with this 
final rule with comment period. We note that these expected benefits 
are qualitative in nature. We expect that the Quality Payment Program 
will result in quality improvements and improvements to the patients' 
experience of care as MIPS eligible clinicians respond to the 
incentives for high-quality care provided by the Program and implement 
care quality improvements in their clinical practices. While we cannot 
quantify these effects specifically at this time because we cannot 
project eligible clinicians' behavioral responses to the incentives 
offered under the Quality Payment Program, we nevertheless believe that 
changes to clinical care will result in care quality improvements for 
Medicare beneficiaries and other patients treated by eligible 
clinicians.

G. Regulatory Impact Statement for Interim Final Rule With Comment 
Period: Medicare Program; Quality Payment Program: Extreme and 
Uncontrollable Circumstance Policy for the Transition Year

    We estimate the implications of adopting the extreme and 
uncontrollable circumstance policy in this interim final rule with 
comment period for the transition year could reduce the amount 
redistributed in the 2019 MIPS payment year by approximately $19.9 
million. We determined this estimate assessing the impact of this 
policy on the potential number of MIPS eligible clinicians and applying 
that to the regulatory impact described in the CY 2017 Quality Payment 
Program final rule. In the CY 2017 Quality Payment Program final rule, 
we estimated approximately $199 million in payment adjustments would be 
redistributed in MIPS on a budget neutral basis (81 FR 77535). 
Additionally, up to $500 million would be distributed for the 
additional MIPS payment adjustment for exceptional performance (81 FR 
77535). We analyzed the MIPS eligibility file from the first 
eligibility run and estimated approximately 10 percent of MIPS eligible 
clinicians practiced in areas affected by the Hurricanes Harvey, Irma, 
and Maria. Based on this finding, we estimate approximately 10 percent 
of MIPS eligible clinicians with a negative payment adjustment may 
receive a neutral payment adjustment which represents approximately 
$19.9 million (10 percent of $199 million). We do not believe that this 
interim final rule with comment period would affect the overall 
distribution of the $500 million for exceptional performance.

List of Subjects

42 CFR Part 414

    Administrative practice and procedure, Biologics, Drugs, Health 
facilities, Health professions, Diseases, Medicare, Reporting and 
recordkeeping requirements.
    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

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

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

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


0
2. Section 414.1305 is amended by--
0
a. Removing the definition of ``Advanced APM Entity'';
0
b. Revising the definition of ``Affiliated practitioner'';
0
c. Adding in alphabetical order a definition for ``Ambulatory Surgical 
Center (ASC)-based MIPS eligible clinician'';
0
d. Revising the definitions of ``APM Entity'' and ``Attributed 
beneficiary'';
0
e. Amending the definition ``Certified Electronic Health Record 
Technology (CEHRT)'' by revising paragraphs (1) introductory text, 
(1)(iii), and (2) introductory text;
0
f. Adding in alphabetical order a definition for ``CMS Multi-Payer 
Model'';
0
g. Adding in alphabetical order a definition for ``Facility-based MIPS 
eligible clinician'';
0
h. Revising the definition of ``Final score'';
0
i. Adding in alphabetical order a definition for ``Full TIN APM'';
0
j. Revising the definition of ``Hospital-based MIPS eligible 
clinician'';
0
k. Adding in alphabetical order a definition for ``Improvement 
scoring'';
0
l. Revising the definitions of ``Low-volume threshold'', ``Medicaid 
APM'',

[[Page 53951]]

and ``Non-patient facing MIPS eligible clinician'';
0
m. Adding in alphabetical order a definition for ``Other MIPS APM'';
0
n. Revising the definition of ``Other Payer Advanced APM'';
0
o. Removing the definition of ``Rural areas'';
0
p. Adding in alphabetical order a definition for ``Rural area'';
0
q. Removing the definition of ``Small practices''; and
0
r. Adding in alphabetical order definitions for ``Small practice'', 
``Solo practitioner'', and ``Virtual group''.
    The revisions and additions read as follows:


Sec.  414.1305  Definitions.

* * * * *
    Affiliated practitioner means an eligible clinician identified by a 
unique APM participant identifier on a CMS-maintained list who has a 
contractual relationship with the APM Entity for the purposes of 
supporting the APM Entity's quality or cost goals under the Advanced 
APM.
* * * * *
    Ambulatory Surgical Center (ASC)-based MIPS eligible clinician 
means a MIPS eligible clinician who furnishes 75 percent or more of his 
or her covered professional services in sites of service identified by 
the Place of Service (POS) codes used in the HIPAA standard transaction 
as an ambulatory surgical center setting based on claims for a period 
prior to the performance period as specified by CMS.
    APM Entity means an entity that participates in an APM or other 
payer arrangement through a direct agreement with CMS or an other payer 
or through Federal or State law or regulation.
* * * * *
    Attributed beneficiary means a beneficiary attributed to the APM 
Entity under the terms of the Advanced APM as indicated on the most 
recent available list of attributed beneficiaries at the time of a QP 
determination.
* * * * *
    Certified Electronic Health Record Technology (CEHRT) * * *:
    (1) For any calendar year before 2019, EHR technology (which could 
include multiple technologies) certified under the ONC Health IT 
Certification Program that meets one of the following:
* * * * *
    (iii) The definition for 2019 and subsequent years specified in 
paragraph (2) of this definition.
    (2) For 2019 and subsequent years, EHR technology (which could 
include multiple technologies) certified under the ONC Health IT 
Certification Program that meets the 2015 Edition Base EHR definition 
(as defined at 45 CFR 170.102) and has been certified to the 2015 
Edition health IT certification criteria--
* * * * *
    CMS Multi-Payer Model means an Advanced APM that CMS determines, 
per the terms of the Advanced APM, has at least one other payer 
arrangement that is designed to align with the terms of that Advanced 
APM.
* * * * *
    Facility-based MIPS eligible clinician means an individual MIPS 
eligible clinician who furnishes 75 percent or more of their covered 
professional services (as defined in section 1848(k)(3)(A) of the Act) 
in sites of service identified by the Place of Service (POS) codes used 
in the HIPAA standard transaction as an inpatient hospital, as 
identified by POS code 21, or an emergency room, as identified by POS 
code 23, based on claims during the facility-based 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 facility-based 
individual MIPS eligible clinician during the facility-based 
determination period.
    Final score means a composite assessment (using a scoring scale of 
0 to 100) for each MIPS eligible clinician for a performance period 
determined using the methodology for assessing the total performance of 
a MIPS eligible clinician according to performance standards for 
applicable measures and activities for each performance category.
    Full TIN APM means an APM where participation is determined at the 
TIN level, and all eligible clinicians who have assigned their billing 
rights to a participating TIN are therefore participating in the APM.
* * * * *
    Hospital-based MIPS eligible clinician means a MIPS eligible 
clinician who furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the place of 
service codes used in the HIPAA standard transaction as an inpatient 
hospital, on-campus outpatient hospital, off campus-outpatient 
hospital, or emergency room setting based on claims for a period prior 
to the performance period as specified by CMS.
* * * * *
    Improvement scoring means an assessment measuring improvement for 
each MIPS eligible clinician or group for a performance period using a 
methodology that compares improvement from one performance period to 
another performance period.
* * * * *
    Low-volume threshold means:
    (1) For the 2019 MIPS payment year, the low-volume threshold that 
applies to an individual eligible clinician or group that, during the 
low-volume threshold determination period described in paragraph (3) of 
this definition, has Medicare Part B allowed charges less than or equal 
to $30,000 or provides care for 100 or fewer Part B-enrolled Medicare 
beneficiaries.
    (2) For the 2020 MIPS payment year and future years, the low-volume 
threshold that applies to an individual eligible clinician or group 
that, during the low-volume threshold determination period described in 
paragraph (3) of this definition, has Medicare Part B allowed charges 
less than or equal to $90,000 or provides care for 200 or fewer Part B-
enrolled Medicare beneficiaries.
    (3) The low-volume threshold determination period is a 24-month 
assessment period consisting of:
    (i) An initial 12-month segment that spans from the last 4 months 
of the calendar year 2 years prior to the performance period through 
the first 8 months of the calendar year preceding the performance 
period; and
    (ii) A second 12-month segment that spans from the last 4 months of 
the calendar year 1 year prior to the performance period through the 
first 8 months of the calendar year performance period. An individual 
eligible clinician or group that is identified as not exceeding the 
low-volume threshold during the initial 12-month segment will continue 
to be excluded under Sec.  414.1310(b)(1)(iii) for the applicable year 
regardless of the results of the second 12-month segment analysis. For 
the 2019 MIPS payment year, each segment of the low-volume threshold 
determination period includes a 60-day claims run out. For the 2020 
MIPS payment year and future years, each segment of the low-volume 
threshold determination period includes a 30-day claims run out.
* * * * *
    Medicaid APM means a payment arrangement authorized by a State 
Medicaid program that meets the Other Payer Advanced APM criteria set 
forth in Sec.  414.1420.
* * * * *
    Non-patient facing MIPS eligible clinician means:
    (1) An individual MIPS eligible clinician who bills 100 or fewer 
patient-facing encounters (including Medicare telehealth services 
defined in section 1834(m) of the Act), as described in

[[Page 53952]]

paragraph (2) of this definition, during the non-patient facing 
determination period described in paragraph (3) of this definition, and 
a group or virtual group provided that more than 75 percent of the NPIs 
billing under the group's TIN or virtual group's TINs, as applicable, 
meet the definition of a non-patient facing individual MIPS eligible 
clinician during the non-patient facing determination period described 
in paragraph (3) of this definition.
    (2) For purposes of this definition, a patient-facing encounter is 
an instance in which the individual MIPS eligible clinician or group 
bills for items and services furnished such as general office visits, 
outpatient visits, and procedure codes under the PFS, as specified by 
CMS.
    (3) For purposes of this definition, the non-patient facing 
determination period is a 24-month assessment period consisting of:
    (i) An initial 12-month segment that spans from the last 4 months 
of the calendar year 2 years prior to the performance period through 
the first 8 months of the calendar year preceding the performance 
period; and
    (ii) A second 12-month segment that spans from the last 4 months of 
the calendar year 1 year prior to the performance period through the 
first 8 months of the calendar year performance period. An individual 
eligible MIPS clinician, group, or virtual group that is identified as 
non-patient facing during the initial 12-month segment will continue to 
be considered non-patient facing for the applicable year regardless of 
the results of the second 12-month segment analysis. For the 2019 MIPS 
payment year, each segment of the non-patient facing determination 
period includes a 60-day claims run out. For the 2020 MIPS payment year 
and future years, each segment of the non-patient facing determination 
period includes a 30-day claims run out.
    Other MIPS APM means a MIPS APM that does not require reporting 
through the CMS Web Interface.
    Other Payer Advanced APM means an other payer arrangement that 
meets the Other Payer Advanced APM criteria set forth in Sec.  
414.1420.
* * * * *
    Rural area means a ZIP code designated as rural, using the most 
recent Health Resources and Services Administration (HRSA) Area Health 
Resource File data set available.
    Small practice means a practice consisting of 15 or fewer eligible 
clinicians.
    Solo practitioner means a practice consisting of 1 eligible 
clinician (who is also a MIPS eligible clinician).
* * * * *
    Virtual group means a combination of two or more TINs assigned to 
one or more solo practitioners or to one or more groups consisting of 
10 or fewer eligible clinicians, or both, that elect to form a virtual 
group for a performance period for a year.

0
3. Section 414.1315 is added to read as follows:


Sec.  414.1315  Virtual groups.

    (a) Eligibility. A solo practitioner or a group of 10 or fewer 
eligible clinicians must make their election to participate in MIPS as 
a virtual group prior to the start of the applicable performance period 
and cannot change their election during the performance period. Virtual 
group participants may elect to be in no more than one virtual group 
for a performance period and, in the case of a group, the election 
applies to all MIPS eligible clinicians in the group. Except as 
provided under Sec.  414.1370(f)(2), each MIPS eligible clinician in 
the virtual group will receive a MIPS payment adjustment based on the 
virtual group's combined performance assessment.
    (b) Election deadline. A virtual group representative must make an 
election, on behalf of the members of a virtual group, regarding the 
formation of a virtual group for an applicable performance period, by 
December 31 of the calendar year preceding the applicable performance 
period.
    (c) Election process. The two-stage virtual group election process 
for the 2018 and 2019 performance years is as follows:
    (1) Stage 1: Virtual group eligibility determination. (i) Solo 
practitioners and groups with 10 or fewer eligible clinicians 
interested in forming or joining a virtual group have the option to 
contact their designated technical assistance representative, as 
applicable, in order to determine whether or not they are eligible to 
participate in MIPS as a virtual group.
    (ii) [Reserved]
    (2) Stage 2: Virtual group formation. (i) TINs comprising a virtual 
group must establish a formal written agreement that satisfies 
paragraph (3) of this section prior to an election.
    (ii) On behalf of a virtual group, the official designated virtual 
group representative must submit an election by December 31 of the 
calendar year prior to the start of the applicable performance period.
    (iii) The submission of a virtual group election must include, at a 
minimum, information pertaining to each TIN and NPI associated with the 
virtual group and contact information for the virtual group 
representative.
    (iv) Once an election is made, the virtual group representative 
must contact their designated CMS contact to update any election 
information that changed during a performance period at least one time 
prior to the start of an applicable submission period.
    (3) Agreement. The virtual group arrangement must be set forth in a 
written agreement among each solo practitioner and group that composes 
a virtual group. The agreement must comply with the following 
requirements:
    (i) Identifies the parties to the agreement by name of party, TIN, 
and NPI, and includes as parties to the agreement only the groups and 
solo practitioners that compose the virtual group.
    (ii) Is executed on behalf of each party by an individual who is 
authorized to bind the party.
    (iii) Expressly requires each member of the virtual group (and each 
NPI under each TIN in the virtual group) to participate in the MIPS as 
a virtual group and comply with the requirements of the MIPS and all 
other applicable laws and regulations (including, but not limited to, 
federal criminal law, False Claims Act, anti-kickback statute, civil 
monetary penalties law, Health Insurance Portability and Accountability 
Act of 1996, and physician self-referral law).
    (iv) Identifies each NPI under each TIN in the virtual group and 
requires each TIN within a virtual group to notify all NPIs associated 
with the TIN regarding their participation in the MIPS as a virtual 
group.
    (v) Sets forth the NPI's rights and obligations in, and 
representation by, the virtual group, including without limitation, the 
reporting requirements and how participation in the MIPS as a virtual 
group affects the ability of the NPI to participate in the MIPS outside 
of the virtual group.
    (vi) Describes how the opportunity to receive payment adjustments 
will encourage each member of the virtual group (and each NPI under 
each TIN in the virtual group) to adhere to quality assurance and 
improvement.
    (vii) Requires each party to the agreement to update its Medicare 
enrollment information, including the addition and deletion of NPIs 
billing through its TIN, on a timely basis in accordance with Medicare 
program requirements and to notify the virtual group of any such 
changes within 30 days after the change.

[[Page 53953]]

    (viii) Is for a term of at least one performance period as 
specified in the formal written agreement.
    (ix) Requires completion of a close-out process upon termination or 
expiration of the agreement that requires each party to the virtual 
group agreement to furnish all data necessary in order for the virtual 
group to aggregate its data across the virtual group.
    (d) Virtual group reporting requirements: For TINs participating in 
MIPS at the virtual group level--
    (1) Individual eligible clinicians and individual MIPS eligible 
clinicians who are part of a TIN participating in MIPS at the virtual 
group level will have their performance assessed as a virtual group.
    (2) Individual eligible clinicians and individual MIPS eligible 
clinicians who are part of a TIN participating in MIPS at the virtual 
group level must meet the definition of a virtual group at all times 
during the performance period for the MIPS payment year.
    (3) Individual eligible clinicians and individual MIPS eligible 
clinicians who are part of a TIN participating in MIPS at the virtual 
group level must aggregate their performance data across multiple TINs 
in order for their performance to be assessed as a virtual group.
    (4) MIPS eligible clinicians that elect to participate in MIPS at 
the virtual group level will have their performance assessed at the 
virtual group level across all four MIPS performance categories.
    (5) Virtual groups must adhere to an election process established 
and required by CMS.

0
4. Section 414.1320 is amended by adding paragraph (c) to read as 
follows:


Sec.  414.1320  MIPS performance period.

* * * * *
    (c) For purposes of the 2021 MIPS payment year, the performance 
period for:
    (1) The quality and cost performance categories is CY 2019 (January 
1, 2019 through December 31, 2019).
    (2) The advancing care information and improvement activities 
performance categories is a minimum of a continuous 90-day period 
within CY 2019, up to and including the full CY 2019 (January 1, 2019 
through December 31, 2019).

0
5. Section 414.1325 is amended by revising paragraphs (c)(4) and (6) 
and (d) to read as follows:


Sec.  414.1325  Data submission requirements.

* * * * *
    (c) * * *
    (4) The CMS Web Interface (for groups consisting of 25 or more 
eligible clinicians) for the quality, improvement activities, and 
advancing care information performance categories.
* * * * *
    (6) A CMS-approved survey vendor for groups that elect to include 
the CAHPS for MIPS survey as a quality measure. Groups that elect to 
include the CAHPS for MIPS survey as a quality measure must select at 
least one other data submission mechanism described in this section to 
submit their other quality information.
    (d) Report measures and activities, as applicable, via multiple 
data submission mechanisms for the quality, improvement activities, or 
advancing care information performance categories. Beginning with the 
2021 MIPS payment year, MIPS eligible clinicians, groups, and virtual 
groups may elect to submit measures and activities, as available, via 
multiple data submission mechanisms for a single performance category 
(specifically, the quality, improvement activities, or advancing care 
information performance category); provided, however, that the MIPS 
eligible clinician, group, or virtual group uses the same identifier 
for all performance categories and all submissions.
* * * * *

0
6. Section 414.1335 is amended by revising the paragraphs (a)(2) 
introductory text and (a)(2)(i) to read as follows:


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

    (a) * * *
    (2) Via the CMS Web Interface--for groups consisting of 25 or more 
eligible clinicians only. (i) Report on all measures included in the 
CMS Web Interface. The group must report on the first 248 consecutively 
ranked beneficiaries in the sample for each measure or module.
* * * * *

0
7. Section 414.1340 is amended by revising paragraphs (a)(1) and (2) 
and (b)(1) and (2) to read as follows:


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

    (a) * * *
    (1) At least 50 percent of the MIPS eligible clinician or group's 
patients that meet the measure's denominator criteria, regardless of 
payer for the MIPS payment years 2019.
    (2) At least 60 percent of the MIPS eligible clinician or group's 
patients that meet the measure's denominator criteria, regardless of 
payer for the MIPS payment years 2020 and 2021.
    (b) * * *
    (1) At least 50 percent of the applicable Medicare Part B patients 
seen during the performance period to which the measure applies for 
MIPS payment years 2019.
    (2) At least 60 percent of the applicable Medicare Part B patients 
seen during the performance period to which the measure applies for 
MIPS payment years 2020 and 2021.
* * * * *

0
8. Section 414.1360 is amended by revising paragraphs (a) introductory 
text and (a)(1) introductory text to read as follows:


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

    (a) For purposes of the transition year of MIPS and future years, 
MIPS eligible clinicians or groups must submit data on MIPS improvement 
activities in one of the following manners:
    (1) Via qualified registries; EHR submission mechanisms; QCDR, CMS 
Web Interface; or attestation. For activities that are performed for at 
least a continuous 90-days during the performance period, MIPS eligible 
clinicians must--
* * * * *

0
9. Section 414.1370 is amended by--
0
a. Revising paragraphs (e) and (f);
0
b. Revising paragraph (g)(1)(i);
0
c. Adding paragraph (g)(1)(ii);
0
d. Revising paragraphs (g)(2), (g)(3)(i), (g)(4)(i), and (g)(4)(ii) 
introductory text;
0
e. Adding paragraph (g)(4)(iii);
0
f. Revising paragraph (h) introductory text, (h)(1)(i) and (ii), 
(h)(3)(i) and (ii), and (h)(4)(i) and (ii);
0
g. Adding paragraph (h)(5); and
0
h. Adding paragraph (i).
    The revisions and additions read as follows:


Sec.  414.1370  APM scoring standard under MIPS.

* * * * *
    (e) APM Entity group determination. For the APM scoring standard, 
the APM Entity group is determined in the manner prescribed in Sec.  
414.1425(b)(1).
    (1) Full TIN APM. In addition to the dates set forth in Sec.  
414.1425(b)(1), the APM Entity group includes an eligible clinician who 
is on a Participation List in a Full TIN APM on December 31 of the MIPS 
performance period.
    (2) [Reserved]
    (f) APM Entity group scoring under the APM scoring standard. The 
MIPS final score calculated for the APM Entity is applied to each MIPS 
eligible clinician in the APM Entity group. The MIPS payment adjustment 
is applied at the TIN/NPI level for each of the MIPS eligible 
clinicians in the APM Entity group.
    (1) If a Shared Savings Program ACO does not report data on quality 
measures

[[Page 53954]]

as required by the Shared Savings Program under Sec.  425.508 of this 
chapter, each ACO participant TIN will be treated as a unique APM 
Entity for purposes of the APM scoring standard and the ACO participant 
TINs may report data for the MIPS quality performance category 
according to the MIPS submission and reporting requirements.
    (2) MIPS eligible clinicians who have elected to participate in a 
virtual group and who are also on a MIPS APM Participation List will be 
included in the assessment under MIPS for purposes of producing a 
virtual group score and under the APM scoring standard for purposes of 
producing an APM Entity score. The MIPS payment adjustment for these 
eligible clinicians is based solely on their APM Entity score.
    (g) * * *
    (1) * * *
    (i) MIPS APMs that require APM Entities to submit quality data 
using the CMS Web Interface. (A) Quality Performance Category Score. 
The quality performance category score for a MIPS performance period is 
calculated for the APM Entity using the data submitted by the APM 
Entity according to the terms of the MIPS APM, including data on 
measures submitted through the CMS Web Interface and other measures 
specified by CMS through notice and comment rulemaking for the APM 
scoring standard.
    (B) Quality Improvement Score. Beginning in 2018, for an APM Entity 
for which CMS calculated a total quality performance category score for 
one or more participants in the APM Entity for the previous MIPS 
performance period, CMS calculates a quality improvement score for the 
APM Entity group as specified in Sec.  414.1380(b)(1)(xvi).
    (C) Total Quality Performance Category Score. Beginning in 2018, 
the total quality performance category score is the sum of the quality 
performance category score, all applicable bonus points provided for by 
Sec.  414.1380(b), and the quality improvement score.
    (ii) Other MIPS APMs--(A) Quality Performance Category Score. The 
MIPS quality performance category score for a MIPS performance period 
is calculated for the APM Entity using the data submitted by the APM 
Entity based on measures specified by CMS through notice and comment 
rulemaking for each Other MIPS APM from among those used under the 
terms of the Other MIPS APM, and which are:
    (1) Tied to payment;
    (2) Available for scoring;
    (3) Have a minimum of 20 cases available for reporting; and
    (4) Have an available benchmark.
    (B) Quality Improvement Score. Beginning in 2019, for an APM Entity 
for which CMS calculated a total quality performance category score for 
the previous MIPS performance period, CMS calculates a quality 
improvement score for the APM Entity group, as specified in Sec.  
414.1380(b)(1)(xvi).
    (C) Total Quality Performance Category Score. Beginning in 2018, 
the total quality performance category score is the sum of the quality 
performance category score, all applicable bonus points provided by 
Sec.  414.1380(b), and the quality improvement score.
    (2) Cost. The cost performance category weight is zero percent for 
APM Entities in MIPS APMs.
    (3) * * *
    (i) CMS assigns an improvement activities score for each MIPS APM 
for a MIPS performance period based on the requirements of the MIPS 
APM. The assigned improvement activities score applies to each APM 
Entity group for the MIPS performance period. In the event that the 
assigned score does not represent the maximum improvement activities 
score, an APM Entity may report additional activities.
* * * * *
    (4) * * *
    (i) Each Shared Savings Program ACO participant TIN must report 
data on the Advancing Care Information (ACI) performance category 
separately from the ACO, as specified in Sec.  414.1375(b)(2). The ACO 
participant TIN scores are weighted according to the number of MIPS 
eligible clinicians in each TIN as a proportion of the total number of 
MIPS eligible clinicians in the APM Entity group, and then aggregated 
to determine an APM Entity score for the ACI performance category.
    (ii) For APM Entities in MIPS APMs other than the Shared Savings 
Program, CMS uses one score for each MIPS eligible clinician in the APM 
Entity group to derive a single average APM Entity score for the ACI 
performance category. The score for each MIPS eligible clinician is the 
higher of either:
* * * * *
    (iii) In the event that a participant TIN in the Shared Savings 
Program or individual MIPS eligible clinician participating in a MIPS 
APM besides the Shared Savings Program receives an exception under 
section 1848(o)(2)(D) of the Act from the advancing care information 
performance category reporting requirements, such participant TIN or 
eligible clinician will be assigned a null score when CMS calculates 
the APM Entity's advancing care information performance category score 
under the APM scoring standard.
    (A) If all participant TINs or MIPS eligible clinicians in an APM 
Entity have been excepted from reporting the advancing care information 
performance category, the performance category weight will be 
reweighted to zero for the APM Entity for that MIPS performance period.
    (B) [Reserved]
    (h) APM scoring standard performance category weights. The 
performance category weights used to calculate the MIPS final score for 
an APM Entity group for the APM scoring standard performance period 
are:
    (1) * * *
    (i) For MIPS APMs that require use of the CMS Web Interface: 50 
percent.
    (ii) For Other MIPS APMs, 0 percent for 2017, 50 percent beginning 
in 2018.
* * * * *
    (3) * * *
    (i) For MIPS APMs that require use of the CMS Web Interface: 20 
percent.
    (ii) For Other MIPS APMs, 25 percent for 2017, 20 percent beginning 
in 2018.
    (4) * * *
    (i) For MIPS APMs that require use of the CMS Web Interface: 30 
percent.
    (ii) For Other MIPS APMs, 25 percent for 2017, 30 percent beginning 
in 2018.
    (5) Reweighting the MIPS Performance categories for the APM scoring 
standard. If CMS determines there are not sufficient measures or 
activities applicable and available to MIPS eligible clinicians, CMS 
will assign weights as follows:
    (i) If CMS reweights the quality performance category to 0 percent:
    (A) In 2017, the improvement activities performance category is 
reweighted to 25 percent and the advancing care information performance 
category is reweighted to 75 percent; and
    (B) Beginning in 2018, the advancing care information performance 
category is reweighted to 80 percent and the improvement activities 
performance category will remain at 20 percent.
    (ii) If CMS reweights the advancing care information performance 
category to 0 percent:
    (A) In 2017, the quality performance category is reweighted to 75 
percent and the improvement activities performance category will remain 
at 25 percent.
    (B) Beginning in 2018, the quality performance category is 
reweighted to 80 percent and the improvement activities performance 
category will remain at 20 percent.
    (i) Total APM Entity Score. CMS scores each performance category 
and then multiplies each performance category score by the applicable 
performance category weight. CMS then

[[Page 53955]]

calculates the sum of each weighted performance category score and then 
applies all applicable adjustments. APM Entities will receive MIPS 
bonuses applied to the final score as set forth in Sec.  414.1380(b).

0
10. Section 414.1375 is amended by revising paragraphs (a) and 
(b)(2)(ii) to read as follows:


Sec.  414.1375  Advancing care information performance category.

* * * * *
    (a) Final score. The advancing care information performance 
category comprises 25 percent of a MIPS eligible clinician's final 
score for the 2019 MIPS payment year and each MIPS payment year 
thereafter, unless a different scoring weight is assigned by CMS.
    (b) * * *
    (2) * * *
    (ii) May claim an exclusion for each measure that includes an 
option for an exclusion.
* * * * *

0
11. Section 414.1380 is revised to read as follows:


Sec.  414.1380  Scoring.

    (a) General. MIPS eligible clinicians are scored under MIPS based 
on their performance on measures and activities in four performance 
categories. MIPS eligible clinicians are scored against performance 
standards for each performance category and receive a final score, 
composed of their scores on individual measures and activities, and 
calculated according to the final score methodology.
    (1) Measures and activities in the four performance categories are 
scored against performance standards. (i) For the quality performance 
category, measures are scored between zero and 10 points. Performance 
is measured against benchmarks. Bonus points are available for both 
submitting specific types of measures and submitting measures using 
end-to-end electronic reporting. Starting with the 2020 MIPS payment 
year, improvement scoring is available in the quality performance 
category.
    (ii) For the cost performance category, measures are scored between 
1 and 10 points. Performance is measured against a benchmark. Starting 
with the 2020 MIPS payment year, improvement scoring is available in 
the cost performance category.
    (iii) For the improvement activities performance category, each 
improvement activity is worth a certain number of points. The points 
for each reported activity are summed and scored against a total 
potential performance category score of 40 points.
    (iv) For the advancing care information performance category, the 
performance category score is the sum of a base score, performance 
score, and bonus score.
    (2) [Reserved]
    (b) Performance categories. MIPS eligible clinicians are scored 
under MIPS in four performance categories.
    (1) Quality performance category. For the 2019 and 2020 MIPS 
payment years, MIPS eligible clinicians receive between 3 and 10 
measure achievement points for each submitted measure that can be 
reliably scored against a benchmark, which requires meeting the case 
minimum and data completeness requirements. A quality measure must have 
a measure benchmark to be scored based on performance. Quality measures 
that do not have a benchmark will not be scored based on performance. 
For the 2019 and 2020 MIPS payment years, MIPS eligible clinicians will 
receive 3 points for measures that are submitted but do not meet the 
required case minimum or do not have a benchmark. For the 2020 MIPS 
payment year, MIPS eligible clinicians will receive 1 point for 
measures that do not meet data completeness criteria, with an exception 
for measures submitted by small practices, which will receive 3 points, 
in accordance with paragraph (b)(1)(vii) of this section.
    (i) Measure benchmarks are based on historical performance for the 
measure based on a baseline period. Each benchmark must have a minimum 
of 20 individual clinicians or groups who reported the measure meeting 
the data completeness requirement and minimum case size criteria and 
performance greater than zero. Benchmark data are separated into decile 
categories based on a percentile distribution. We will restrict the 
benchmarks to data from MIPS eligible clinicians and comparable APM 
data, including data from QPs and Partial QPs.
    (ii) As an exception, if there is no comparable data from the 
baseline period, CMS would use information from the performance period 
to create measure benchmarks, as described in paragraph (b)(1)(i) of 
this section, which would not be published until after the performance 
period. For the 2019 MIPS payment year, CMS would use information from 
CY 2017 during which MIPS eligible clinicians may report for a minimum 
of any continuous 90-day period.
    (A) CMS Web Interface submission uses benchmarks from the 
corresponding reporting year of the Shared Savings Program.
    (B) [Reserved]
    (iii) Separate benchmarks are used for the following submission 
mechanisms:
    (A) EHR submission options;
    (B) QCDR and qualified registry submission options;
    (C) Claims submission options;
    (D) CMS Web Interface submission options;
    (E) CMS-approved survey vendor for CAHPS for MIPS submission 
options; and
    (F) Administrative claims submission options.
    (iv) Minimum case requirements for quality measures are 20 cases, 
unless a measure is subject to an exception.
    (v) As an exception, the minimum case requirements for the all-
cause hospital readmission measure is 200 cases.
    (vi) MIPS eligible clinicians failing to report a measure required 
under this category receive zero points for that measure.
    (vii) Subject to paragraph (b)(1)(viii) of this section, MIPS 
eligible clinicians do not receive zero points if the expected measure 
is submitted but is unable to be scored because it does not meet the 
required case minimum or if the measure does not have a measure 
benchmark for MIPS payment years 2019 and 2020. Instead, these measures 
receive a score of 3 points in MIPS payment years 2019 and 2020. MIPS 
eligible clinicians do not receive zero points if the expected measure 
is submitted but is unable to be scored because it is below the data 
completeness requirement. Instead, these measures receive a score of 3 
points in the 2019 MIPS payment year and a score of 1 point in the 2020 
MIPS payment year, except if the measure is submitted by a small 
practice. Measures below the data completeness requirement submitted by 
a small practice receive a score of 3 points in the 2020 MIPS payment 
year.
    (viii) As an exception, the administrative claims-based measures 
and CMS Web Interface measures will not be scored if these measures do 
not meet the required case minimum. For CMS Web Interface measures, we 
will recognize the measure was submitted but exclude the measure from 
being scored. For CMS Web Interface measures: Measures that do not have 
a measure benchmark and measures that have a measure benchmark but are 
redesignated as pay for reporting for all Shared Savings Program 
accountable care organizations by the Shared Savings Program, CMS will 
recognize the measure was submitted but exclude the measure from being 
scored as long as the data completeness requirement is met. CMS Web 
Interface measures that

[[Page 53956]]

are below the data completeness requirement will be scored and receive 
0 points.
    (ix) Measures submitted by MIPS eligible clinicians are scored 
against measure benchmarks using a percentile distribution, separated 
by decile categories.
    (x) For each set of benchmarks, CMS calculates the decile breaks 
for measure performance and assigns points based on which benchmark 
decile range the MIPS eligible clinician's measure rate is between.
    (xi) CMS assigns partial points based on the percentile 
distribution.
    (xii) MIPS eligible clinicians are required to submit measures 
consistent with Sec.  414.1335.
    (A) MIPS eligible clinicians that submit measures via claims, 
qualified registry, EHR, or QCDR submission mechanisms, and submit more 
than the required number of measures are scored on the required 
measures with the highest measure achievement points. Beginning in the 
2021 MIPS payment year, MIPS eligible clinicians that report a measure 
via more than one submission mechanism can be scored on only one 
submission mechanism for that measure, which will be the submission 
mechanism with the highest measure achievement points. Groups that 
submit via these submission options may also submit and be scored on 
CMS-approved survey vendor for CAHPS for MIPS submission mechanisms.
    (B) Groups that submit measures via the CMS Web Interface may also 
submit and be scored on CMS-approved survey vendor for CAHPS for MIPS 
submission mechanisms.
    (xiii) CMS will identify topped out measures in the benchmarks 
published for each Quality Payment Program year.
    (A) For the 2020 MIPS payment year, selected topped out measures 
identified by CMS will receive no more than 7 measure achievement 
points, provided that the measure benchmarks for the applicable 
submission mechanisms are identified as topped out in the benchmarks 
published for the 2018 MIPS performance period.
    (B) Beginning with the 2021 MIPS payment year, a measure, except 
for measures in the CMS Web Interface, whose benchmark is identified as 
topped out for 2 or more consecutive years will receive no more than 7 
measure achievement points in the second consecutive year it is 
identified as topped out, and beyond.
    (xiv) Measure bonus points are available for measures determined to 
be high priority measures when two or more high priority measures are 
reported.
    (A) Measure bonus points are not available for the first reported 
high priority measure which is required to be reported. To qualify for 
measure bonus points, each measure must be reported with sufficient 
case volume to meet the required case minimum, meet the required data 
completeness criteria, and not have a zero percent performance rate. 
Measure bonus points may be included in the calculation of the quality 
performance category percent score regardless of whether the measure is 
included in the calculation of the total measure achievement points.
    (B) Outcome and patient experience measures receive two measure 
bonus points.
    (C) Other high priority measures receive one measure bonus point.
    (D) Measure bonus points for high priority measures cannot exceed 
10 percent of the total available measure achievement points for the 
2019 and 2020 MIPS payment years.
    (E) If the same high priority measure is submitted via two or more 
submission mechanisms, the measure will receive high priority measure 
bonus points only once for the measure beginning in the 2021 MIPS 
payment year.
    (xv) One measure bonus point is also available for each measure 
submitted with end-to-end electronic reporting for a quality measure 
under certain criteria determined by the Secretary. Bonus points cannot 
exceed 10 percent of the total available measure achievement points for 
the 2019 and 2020 MIPS payment years. If the same measure is submitted 
via 2 or more submission mechanisms, the measure will receive measure 
bonus points only once for the measure beginning in the 2021 MIPS 
payment year.
    (xvi) Improvement scoring is available to MIPS eligible clinicians 
that demonstrate improvement in performance in the current MIPS 
performance period compared to performance in the performance period 
immediately prior to the current MIPS performance period based on 
measure achievement points.
    (A) Improvement scoring is available when the data sufficiency 
standard is met, which means when data are available and a MIPS 
eligible clinician has a quality performance category achievement 
percent score for the previous performance period and the current 
performance period.
    (1) Data must be comparable to meet the requirement of data 
sufficiency which means that the quality performance category 
achievement percent score is available for the current performance 
period and the previous performance period and quality performance 
category achievement percent scores can be compared.
    (2) Quality performance category achievement percent scores are 
comparable when submissions are received from the same identifier for 
two consecutive performance periods.
    (3) If the identifier is not the same for 2 consecutive performance 
periods, then for individual submissions, the comparable quality 
performance category achievement percent score is the highest available 
quality performance category achievement percent score associated with 
the final score from the prior performance period that will be used for 
payment for the individual. For group, virtual group, and APM Entity 
submissions, the comparable quality performance category achievement 
percent score is the average of the quality performance category 
achievement percent score associated with the final score from the 
prior performance period that will be used for payment for each of the 
individuals in the group.
    (B) The improvement percent score may not total more than 10 
percentage points.
    (C) The improvement percent score is assessed at the performance 
category level for the quality performance category and included in the 
calculation of the quality performance category percent score as 
described in paragraph (b)(1)(xvii) of this section.
    (1) The improvement percent score is awarded based on the rate of 
increase in the quality performance category achievement percent score 
of MIPS eligible clinicians from the previous performance period to the 
current performance period.
    (2) An improvement percent score is calculated by dividing the 
increase in the quality performance category achievement percent score 
from the prior performance period to the current performance period by 
the prior performance period quality performance category achievement 
percent score multiplied by 10 percent.
    (3) An improvement percent score cannot be lower than zero 
percentage points.
    (4) For the 2020 MIPS payment year, if a MIPS eligible clinician 
has a previous year quality performance category achievement percent 
score less than or equal to 30 percent, then the 2018 performance will 
be compared to an assumed 2017 quality performance category achievement 
percent score of 30 percent.
    (5) The improvement percent score is zero if the MIPS eligible 
clinician did not fully participate in the quality

[[Page 53957]]

performance category for the current performance period.
    (D) For the purpose of improvement scoring methodology, the term 
``quality performance category achievement percent score'' means the 
total measure achievement points divided by the total available measure 
achievement points, without consideration of measure bonus points or 
improvement percent score.
    (E) For the purpose of improvement scoring methodology, the term 
``improvement percent score'' means the score that represents 
improvement for the purposes of calculating the quality performance 
category percent score as described in paragraph (b)(1)(xvii) of this 
section.
    (F) For the purpose of improvement scoring methodology, the term 
``fully participate'' means the MIPS eligible clinician met all 
requirements in Sec. Sec.  414.1330 and 414.1340.
    (xvii) A MIPS eligible clinician's quality performance category 
percent score is the sum of all the measure achievement points assigned 
for the measures required for the quality performance category criteria 
plus the measure bonus points in paragraph (b)(1)(xiv) of this section 
and measure bonus points in paragraph (b)(1)(xv) of this section. The 
sum is divided by the sum of total available measure achievement 
points. The improvement percent score in paragraph (b)(1)(xvi) of this 
section is added to that result. The quality performance category 
percent score cannot exceed 100 percentage points.
    (xviii) Beginning with the 2018 MIPS performance period, measures 
significantly impacted by ICD-10 updates, as determined by CMS, will be 
assessed based only on the first 9 months of the 12-month performance 
period. For purposes of this paragraph, CMS will make a determination 
as to whether a measure is significantly impacted by ICD-10 coding 
changes during the performance period. CMS will publish on the CMS Web 
site which measures require a 9-month assessment process by October 1st 
of the performance period if technically feasible, but by no later than 
the beginning of the data submission period at Sec.  414.1325(f)(1).
    (2) Cost performance category. A MIPS eligible clinician receives 
one to ten achievement points for each cost measure attributed to the 
MIPS eligible clinician based on the MIPS eligible clinician's 
performance compared to the measure benchmark.
    (i) Cost measure benchmarks are based on the performance period. 
Cost measures must have a benchmark to be scored.
    (ii) A MIPS eligible clinician must meet the minimum case volume 
specified by CMS to be scored on a cost measure.
    (iii) A MIPS eligible clinician cost performance category percent 
score is the sum of the following, not to exceed 100 percent:
    (A) The total number of achievement points earned by the MIPS 
eligible clinician divided by the total number of available achievement 
points; and
    (B) The cost improvement score, as determined under paragraph 
(b)(2)(iv) of this section.
    (iv) Cost improvement scoring is available to MIPS eligible 
clinicians that demonstrate improvement in performance in the current 
MIPS performance period compared to their performance in the 
immediately preceding MIPS performance period.
    (A) The cost improvement score is determined at the measure level 
for the cost performance category.
    (B) The cost improvement score is calculated only when data 
sufficient to measure improvement is available. Sufficient data is 
available when a MIPS eligible clinician or group participates in MIPS 
using the same identifier in 2 consecutive performance periods and is 
scored on the same cost measure(s) for 2 consecutive performance 
periods. If the cost improvement score cannot be calculated because 
sufficient data is not available, then the cost improvement score is 
zero.
    (C) The cost improvement score is determined by comparing the 
number of measures with a statistically significant change (improvement 
or decline) in performance; a change is determined to be significant 
based on application of a t-test. The number of cost measures with a 
significant decline is subtracted from the number of cost measures with 
a significant improvement, with the result divided by the number of 
cost measures for which the MIPS eligible clinician or group was scored 
for two consecutive performance periods. The resulting fraction is then 
multiplied by the maximum improvement score.
    (D) The cost improvement score cannot be lower than zero percentage 
points.
    (E) The maximum cost improvement score for the 2020 MIPS payment 
year is 1 percentage point.
    (v) A cost performance category percent score is not calculated if 
a MIPS eligible clinician is not attributed any cost measures because 
the clinician or group has not met the case minimum requirements for 
any of the cost measures or a benchmark has not been created for any of 
the cost measures that would otherwise be attributed to the clinician 
or group.
    (3) Improvement activities performance category. MIPS eligible 
clinicians and groups receive points for improvement activities based 
on patient-centered medical home or comparable specialty practice 
participation, APM participation, and improvement activities reported 
by the MIPS eligible clinician in comparison to the highest potential 
score (40 points) for a given MIPS year. For purposes of this 
paragraph, ``full credit'' means that the MIPS eligible clinician or 
group has met the highest potential score for the improvement 
activities performance category.
    (i) CMS assigns credit for the total possible category score for 
each reported improvement activity based on two weights: Medium-
weighted and high-weighted activities.
    (ii) Improvement activities with a high weighting receive credit 
for 20 points, toward the total possible category score.
    (iii) Improvement activities with a medium weighting receive credit 
for 10 points toward the total possible category score.
    (iv) A MIPS eligible clinician or group in a practice that is 
certified or recognized as a patient-centered medical home or 
comparable specialty practice, as determined by the Secretary, receives 
full credit for performance on the improvement activities performance 
category. A practice is certified or recognized as a patient-centered 
medical home if it meets any of the following criteria:
    (A) The practice has received accreditation from one of four 
accreditation organizations that are nationally recognized;
    (1) The Accreditation Association for Ambulatory Health Care;
    (2) The National Committee for Quality Assurance (NCQA);
    (3) The Joint Commission; or
    (4) The Utilization Review Accreditation Commission (URAC).
    (B) The practice is participating in a Medicaid Medical Home Model 
or Medical Home Model.
    (C) The practice is a comparable specialty practice that has 
received the NCQA Patient-Centered Specialty Recognition.
    (D) The practice has received accreditation from other certifying 
bodies that have certified a large number of medical organizations and 
meet national guidelines, as determined by the Secretary. The Secretary 
must determine that these certifying bodies must have 500 or more 
certified member

[[Page 53958]]

practices, and require practices to include the following:
    (1) Have a personal physician/clinician in a team-based practice.
    (2) Have a whole-person orientation.
    (3) Provide coordination or integrated care.
    (4) Focus on quality and safety.
    (5) Provide enhanced access.
    (v) CMS compares the points associated with the reported activities 
against the highest potential category score of 40 points.
    (vi) A MIPS eligible clinician or group's improvement activities 
category score is the sum of points for all of their reported 
activities, which is capped at 40 points, divided by the highest 
potential category score of 40 points.
    (vii) Non-patient facing MIPS eligible clinicians and groups, small 
practices, and practices located in rural areas and geographic HPSAs 
receive full credit for improvement activities by selecting one high-
weighted improvement activity or two medium-weighted improvement 
activities. Non-patient facing MIPS eligible clinicians and groups, 
small practices, and practices located in rural areas and geographic 
HPSAs receive half credit for improvement activities by selecting one 
medium-weighted improvement activity.
    (viii) For the transition year, to receive full credit as a 
certified or recognized patient-centered medical home or comparable 
specialty a TIN that is reporting must include at least one practice 
site which is a certified patient-centered medical home or comparable 
specialty practice.
    (ix) MIPS eligible clinicians participating in APMs that are not 
patient-centered medical homes for a performance period shall earn a 
minimum score of one-half of the highest potential score for the 
improvement activities performance category.
    (x) For the 2020 MIPS payment year and future years, to receive 
full credit as a certified or recognized patient-centered medical home 
or comparable specialty practice, at least 50 percent of the practice 
sites within the TIN must be recognized as a patient-centered medical 
home or comparable specialty practice.
    (4) Advancing care information performance category. (i) A MIPS 
eligible clinician's advancing care information performance category 
score equals the sum of the base score, performance score, and any 
applicable bonus scores. A MIPS eligible clinician cannot earn the 
performance score or base score until they have fulfilled the base 
score. The advancing care information performance category score will 
not exceed 100 percentage points.
    (A) A MIPS eligible clinician earns a base score by reporting the 
numerator (of at least one) and denominator or a yes/no statement or an 
exclusion; as applicable, for each required measure.
    (B) A MIPS eligible clinician earns a performance score by 
reporting on certain measures specified by CMS. MIPS eligible 
clinicians may earn up to 10 or 20 percentage points as specified by 
CMS for each measure reported for the performance score.
    (C) A MIPS eligible clinician may earn the following bonus scores:
    (1) A bonus score of 5 percentage points for reporting to one or 
more additional public health agencies or clinical data registries.
    (2) A bonus score of 10 percentage points for attesting to 
completing one or more improvement activities specified by CMS using 
CEHRT.
    (3) For the 2020 MIPS payment year, a bonus score of 10 percentage 
points for submitting data for the measures for the base score and the 
performance score generated solely from 2015 Edition CEHRT.
    (c) Final score calculation. Each MIPS eligible clinician receives 
a final score of 0 to 100 points for a performance period for a MIPS 
payment year calculated as follows:

    Final score = [(quality performance category percent score x 
quality performance category weight) + (cost performance category 
percent score x cost performance category weight) + (improvement 
activities performance category score x improvement activities 
performance category weight) + (advancing care information performance 
category score x advancing care information performance category 
weight)] x 100 + [the complex patient bonus + the small practice 
bonus], not to exceed 100 points.

    If a MIPS eligible clinician is scored on fewer than 2 performance 
categories, he or she receives a final score equal to the performance 
threshold.
    (1) Performance category weights. The weights of the performance 
categories in the final score are as follows, unless a different 
scoring weight is assigned under paragraph (c)(2) of this section:
    (i) Quality performance category weight is defined under Sec.  
414.1330(b).
    (ii) Cost performance category weight is defined under Sec.  
414.1350(b).
    (iii) Improvement activities performance category weight is defined 
under Sec.  414.1355(b).
    (iv) Advancing care information performance category weight is 
defined under Sec.  414.1375(a).
    (2) Reweighting the performance categories. A scoring weight 
different from the weights specified in paragraph (c)(1) of this 
section will be assigned to a performance category, and its weight as 
specified in paragraph (c)(1) of this section will be redistributed to 
another performance category or categories, in the following 
circumstances:
    (i) CMS determines there are not sufficient measures and activities 
applicable and available to MIPS eligible clinicians pursuant to 
section 1848(q)(5)(F) of the Act.
    (ii) CMS estimates that the proportion of eligible professionals 
who are meaningful EHR users is 75 percent or greater pursuant to 
section 1848(q)(5)(E)(ii) of the Act.
    (iii) A significant hardship exception or other type of exception 
is granted to a MIPS eligible clinician for the advancing care 
information performance category pursuant to section 1848(o)(2)(D) of 
the Act.
    (3) Complex patient bonus. Provided that the MIPS eligible 
clinician, group, virtual group or APM entity submits data for at least 
one MIPS performance category during the 2018 MIPS performance period, 
a complex patient bonus will be added to the final score for the 2020 
MIPS payment year, as follows:
    (i) For MIPS eligible clinicians and groups, the complex patient 
bonus is calculated as follows: [The average HCC risk score assigned to 
beneficiaries (pursuant to the HCC risk adjustment model established by 
CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS 
eligible clinician or seen by clinicians in a group] + [the dual 
eligible ratio x 5].
    (ii) For APM entities and virtual groups, the complex patient bonus 
is calculated as follows: [The beneficiary weighted average HCC risk 
score for all MIPS eligible clinicians, and if technically feasible, 
TINs for models and virtual groups which rely on complete TIN 
participation within the APM entity or virtual group, respectively] + 
[the average dual eligible ratio for all MIPS eligible clinicians, and 
if technically feasible, TINs for models and virtual groups which rely 
on complete TIN participation, within the APM entity or virtual group, 
respectively, x 5].
    (iii) The complex patient bonus cannot exceed 5.0.
    (4) Small practice bonus. A small practice bonus of 5 points will 
be added to the final score for the 2020 MIPS payment year for MIPS 
eligible clinicians, groups, virtual groups, and APM Entities that meet 
the definition of a small practice as defined at Sec.  414.1305

[[Page 53959]]

and participate in MIPS by submitting data on at least one performance 
category in the 2018 MIPS performance period.
    (d) Scoring for APM Entities. MIPS eligible clinicians in APM 
Entities that are subject to the APM scoring standard are scored using 
the methodology under Sec.  414.1370.
    (e) Scoring for facility-based measurement. For the payment in 2021 
MIPS payment year and subsequent years, a MIPS eligible clinician or 
group may elect to be scored under the quality and cost performance 
categories using facility-based measures under the methodology 
described in this paragraph.
    (1) General. The facility-based measurement scoring standard is the 
MIPS scoring methodology applicable for MIPS eligible clinicians 
identified as meeting the requirements in paragraphs (e)(2) and (3) of 
this section.
    (2) Eligibility for facility-based measurement. MIPS eligible 
clinicians are eligible for facility-based measurement for a MIPS 
payment year if they are determined to be facility-based as an 
individual clinician or as part of a group, as follows:
    (i) Facility-based individual determination. A MIPS eligible 
clinician furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the place of 
service codes used in the HIPAA standard transaction as an inpatient 
hospital or emergency room setting based on claims for a period prior 
to the performance period as specified by CMS.
    (ii) Facility-based group determination. A facility-based group is 
a group in which 75 percent or more of its eligible clinician NPIs 
billing under the group's TIN meet the requirements under paragraph 
(e)(2)(i) of this section.
    (3) [Reserved].
    (4) Data submission for facility-based measurement. There are no 
data submission requirements for clinicians that elect facility-based 
measurement.
    (5) Determination of applicable facility score. A facility-based 
clinician or group receives a score under the facility-based 
measurement scoring standard derived from the value-based purchasing 
score for the facility at which the clinician or group provided 
services to the most Medicare beneficiaries during the year the claims 
are drawn from in paragraph (e)(2) of this section. If there is an 
equal number of Medicare beneficiaries treated at more than one 
facility, the value-based purchasing score for the highest scoring 
facility is used.
    (6) MIPS performance category scoring under the facility-based 
measurement scoring standard--(i) Measures. The quality and cost 
measures are those adopted under the value-based purchasing program of 
the facility for the year specified.
    (ii) Benchmarks. The benchmarks are those adopted under the value-
based purchasing program of the facility program for the year 
specified.
    (iii) Performance period. The performance period for facility-based 
measurement is the performance period for the measures adopted under 
the value-based purchasing program of the facility program for the year 
specified.
    (iv) Quality. The quality performance category percent score is 
established by determining the percentile performance of the facility 
in the value-based purchasing program for the specified year as 
described in paragraph (e)(5) of this section and awarding a score 
associated with that same percentile performance in the MIPS quality 
performance category percent score for those MIPS-eligible clinicians 
who are not scored using facility-based measurement for the MIPS 
payment year.
    (v) Cost. The cost performance category percent score is 
established by determining the percentile performance of the facility 
in the value-based purchasing program for the specified year as 
described in paragraph (e)(5) of this section and awarding a score 
associated with that same percentile performance in the MIPS cost 
performance category percent score [for those MIPS eligible clinicians 
who are not scored using facility-based measurement] for the MIPS 
payment year.
    (A) Other cost measures. MIPS eligible clinicians who elect 
facility-based measurement are not scored on cost measures described in 
paragraph (b)(2) of this section.
    (B) [Reserved].

0
12. Section 414.1390 is amended by adding paragraphs (b) through (d) to 
read as follows:


Sec.  414.1390  Data validation and auditing.

* * * * *
    (b) Certification. All MIPS eligible clinicians and groups that 
submit data and information to CMS for purposes of MIPS must certify to 
the best of their knowledge that the data submitted to CMS is true, 
accurate, and complete. Such certification must accompany the 
submission and be made at the time of submission.
    (c) Reopening. CMS may reopen and revise a MIPS payment adjustment 
in accordance with the rules set forth at Sec. Sec.  405.980 through 
405.986 of this chapter.
    (d) Record retention. All MIPS eligible clinicians and groups that 
submit data and information to CMS for purposes of MIPS must retain 
such data and information for 6 years from the end of the MIPS 
performance period.

0
13. Section 414.1395 is revised to read as follows:


Sec.  414.1395  Public reporting.

    (a) Public reporting of eligible clinician and group Quality 
Payment Program information. For each program year, CMS posts on 
Physician Compare, in an easily understandable format, information 
regarding the performance of eligible clinicians or groups under the 
Quality Payment Program.
    (b) Maintain existing public reporting standards. With the 
exception of data that must be mandatorily reported on Physician 
Compare, for each program year, CMS relies on established public 
reporting standards to guide the information available for inclusion on 
Physician Compare. The public reporting standards require data included 
on Physician Compare to be statistically valid, reliable, and accurate; 
comparable across submission mechanisms; and meet the reliability 
threshold. And, to be included on the public facing profile pages, the 
data must also resonate with Web site users, as determined by CMS.
    (c) First year measures. For each program year, CMS does not 
publicly report any first year measure, meaning any measure in its 
first year of use in the quality and cost performance categories. After 
the first year, CMS reevaluates measures to determine when and if they 
are suitable for public reporting.
    (d) 30-day preview period. For each program year, CMS provides a 
30-day preview period for any clinician or group with Quality Payment 
Program data before the data are publicly reported on Physician 
Compare.

0
14. Section 414.1400 is amended by--
0
a. Revising paragraph (a)(1) introductory text;
0
b. Adding paragraph (a)(5);
0
c. Revising paragraphs (b), (e) introductory text, (e)(3), (f), (g), 
(i), and (j)(2) and (3).
    The revisions and addition read as follows:


Sec.  414.1400  Third party data submission.

    (a) * * *
    (1) MIPS data may be submitted by third party intermediaries on 
behalf of a MIPS eligible clinician, group or virtual group by:
* * * * *

[[Page 53960]]

    (5) All data submitted to CMS by a third party intermediary on 
behalf of a MIPS eligible clinician, group or virtual group must be 
certified by the third party intermediary to the best of its knowledge 
as true, accurate, and complete. Such certification must accompany the 
submission and be made at the time of the submission.
    (b) QCDR self-nomination criteria. For the 2018 performance period 
and future years of the program, QCDRs must self-nominate from 
September 1 of the prior year until November 1 of the prior year. 
Entities that desire to qualify as a QCDR for the purposes of MIPS for 
a given performance period will need to self-nominate for that 
performance period and provide all information requested by CMS at the 
time of self-nomination. Having qualified as a QCDR does not 
automatically qualify the entity to participate in subsequent MIPS 
performance periods. Beginning with the 2019 performance period 
existing QCDRs that are in good standing may attest that certain 
aspects of their previous year's approved self-nomination have not 
changed and will be used for the upcoming performance period. CMS may 
allow existing QCDRs in good standing to submit minimal or substantial 
changes to their previously approved self-nomination form, from the 
previous year, during the annual self-nomination period, for CMS review 
and approval without having to complete the entire QCDR self-nomination 
application process.
* * * * *
    (e) Identifying QCDR quality measures. Beginning with the 2018 
performance period and for future program years, the term ``non-MIPS 
measures'' will be replaced with the term ``QCDR measures''. For 
purposes of QCDRs submitting data for the MIPS quality performance 
category, CMS considers the following types of quality measures to be 
QCDR quality measures:
* * * * *
    (3) CAHPS for MIPS survey. Although the CAHPS for MIPS survey is 
included in the MIPS measure set, we consider the changes that need to 
be made to the CAHPS for MIPS survey for reporting by individual MIPS 
eligible clinicians (and not as a part of a group) significant enough 
as to treat the CAHPS for MIPS survey as a QCDR quality measure for 
purposes of individual MIPS eligible clinicians reporting the CAHPS for 
MIPS survey via a QCDR.
    (f) QCDR measure specifications criteria. A QCDR must provide 
specifications for each measure, activity, or objective the QCDR 
intends to submit to CMS. The QCDR must provide CMS descriptions and 
narrative specifications for each measure, activity, or objective no 
later than November 1 of the applicable performance period for which 
the QCDR wishes to submit quality measures or other performance 
category (improvement activities and advancing care information) data 
starting with the 2018 performance period and in future program years.
    (1) For QCDR quality measures, the quality measure specifications 
must include the following for each measure: Name/title of measures, 
NQF number (if NQF-endorsed), descriptions of the denominator, 
numerator, and when applicable, denominator exceptions, denominator 
exclusions, risk adjustment variables, and risk adjustment algorithms. 
The narrative specifications provided must be similar to the narrative 
specifications we provide in our measures list.
    (2) For MIPS quality measures, the QCDR only needs to submit the 
MIPS measure numbers or specialty-specific measure sets (if 
applicable). CMS expects that QCDRs reporting on MIPS measures, retain 
and use the MIPS measure specifications as they exist under the program 
year.
    (3) The QCDR must publicly post the measure specifications no later 
than 15 calendar days following CMS approval of the measure 
specifications for each QCDR measure it intends to submit for MIPS. The 
QCDR may use any public format it prefers. Immediately following the 
posting of the measure specification, the QCDR must provide CMS with 
the link to where this information is posted.
    (g) Qualified registry self-nomination criteria. For the 2018 
performance period and future years of the program, the qualified 
registry must self-nominate from September 1 of the prior year until 
November 1 of the prior year. Entities that desire to qualify as a 
qualified registry for a given performance period must self-nominate 
and provide all information requested by CMS at the time of self-
nomination. Having qualified as a qualified registry does not 
automatically qualify the entity to participate in subsequent MIPS 
performance periods. Beginning with the 2019 performance period, 
existing qualified registries that are in good standing may attest that 
certain aspects of their previous year's approved self-nomination have 
not changed and will be used for the upcoming performance period. CMS 
may allow existing qualified registries in good standing to submit 
minimal or substantive changes to their previously approved self-
nomination form from the previous year, during the annual self-
nomination period, for CMS review and approval without having to 
complete the entire qualified registry self-nomination application 
process.
* * * * *
    (i) CMS-approved survey vendor application criteria. Vendors are 
required to undergo the CMS approval process for each year in which the 
survey vendor seeks to transmit survey measures data to CMS. Applicants 
must adhere to any deadlines specified by CMS.
    (j) * * *
    (2) The entity must retain all data submitted to CMS for purposes 
of MIPS for 6 years from the end of the MIPS performance period.
    (3) For the purposes of auditing, CMS may request any records or 
data retained for the purposes of MIPS for up to 6 years from the end 
of the MIPS performance period.
* * * * *

0
15. Section 414.1405 is amended by adding paragraphs (b)(4) and (5) and 
(d)(3) and (4) to read as follows:


Sec.  414.1405  Payment.

* * * * *
    (b) * * *
    (4) The performance threshold for the 2019 MIPS payment year is 3 
points.
    (5) The performance threshold for the 2020 MIPS payment year is 15 
points.
* * * * *
    (d) * * *
    (3) The additional performance threshold for the 2019 MIPS payment 
year is 70 points.
    (4) The additional performance threshold for the 2020 MIPS payment 
year is 70 points.
* * * * *

0
16. Section 414.1410 is amended by revising the paragraph (b) 
introductory text and removing and reserving paragraph (b)(2).
    The revision reads as follows:


Sec.  414.1410  Advanced APM determination.

* * * * *
    (b) Advanced APM determination process. CMS determines Advanced 
APMs in the following manner:
* * * * *

0
17. Section 414.1415 is amended by--
0
a. Revising paragraphs (c) introductory text, (c)(2) introductory text, 
(c)(3)(i)(A), and (c)(4); and
0
b. Adding paragraph (c)(7).
    The revisions and addition read as follows:


Sec.  414.1415  Advanced APM criteria.

* * * * *
    (c) Financial risk. To be an Advanced APM, an APM must either meet 
the financial risk standard under paragraph

[[Page 53961]]

(c)(1) or (2) of this section and the nominal amount standard under 
paragraph (c)(3) or (4) of this section or be an expanded Medical Home 
Model under Section 1115A(c) of the Act.
* * * * *
    (2) Medical Home Model financial risk standard. The APM Entity 
participates in a Medical Home Model that, based on the APM Entity's 
failure to meet or exceed one or more specified performance standards, 
which may include expected expenditures, does one or more of the 
following:
* * * * *
    (3) * * *
    (i) * * *
    (A) For QP Performance Periods 2017, 2018, 2019, and 2020, 8 
percent of the average estimated total Medicare Parts A and B revenue 
of all providers and suppliers in participating APM Entities; or
* * * * *
    (4) Medical Home Model nominal amount standard. (i) For a Medical 
Home Model to meet the Medical Home Model nominal amount standard, the 
total annual amount that an APM Entity potentially owes CMS or foregoes 
must be at least the following amounts:
    (A) For QP Performance Period 2017, 2.5 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
    (B) For QP Performance Period 2018, 2.5 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
    (C) For QP Performance Period 2019, 3 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
    (D) For QP Performance Period 2020, 4 percent of the average 
estimated total Medicare Parts A and B revenue of all providers and 
suppliers in participating APM Entities.
    (E) For QP Performance Periods 2021 and later, 5 percent of the 
average estimated total Medicare Parts A and B revenue of all providers 
and suppliers in participating APM Entities.
    (ii) [Reserved]
* * * * *
    (7) Medical Home Model 50 eligible clinician limit. Notwithstanding 
paragraphs (c)(2) and (4) of this section, beginning in the 2018 QP 
Performance Period, if an APM Entity participating in a Medical Home 
Model other than Round 1 of the Comprehensive Primary Care Plus (CPC+) 
Model is owned and operated by an organization with 50 or more eligible 
clinicians whose Medicare billing rights have been reassigned to the 
TIN(s) of the organization(s) or any of the organization's subsidiary 
entities, the requirements of paragraphs (c)(1) and (c)(3) of this 
section apply.

0
18. Section 414.1420 is amended by--
0
a. Revising the section heading and paragraphs (a)(3)(i) and (ii), the 
paragraph (c) subject heading, paragraphs (c)(2) introductory text, 
(c)(3), (d) introductory text, (d)(1) introductory text, (d)(2) 
introductory text, (d)(3) introductory text, (d)(3)(i), and (d)(4); and
0
b. Adding paragraph (d)(8).
    The revisions and addition read as follows:


Sec.  414.1420  Other payer advanced APM criteria.

    (a) * * *
    (3) * * *
    (i) Requires APM Entities to bear more than nominal financial risk 
if actual aggregate expenditures exceed expected aggregate expenditures 
as described in paragraph (d) of this section; or
    (ii) Is a Medicaid Medical Home Model that meets criteria 
comparable to Medical Home Models expanded under section 1115A(c) of 
the Act as described in paragraph (d) of this section.
* * * * *
    (c) Use of quality measures.
* * * * *
    (2) At least one of the quality measures used in the payment 
arrangement must have an evidence-based focus, be reliable and valid, 
and meet at least one of the following criteria:
* * * * *
    (3) To meet the quality measure use criterion, a payment 
arrangement must use an outcome measure if there is an applicable 
outcome measure on the MIPS quality measure list.
    (d) Financial risk. To be an Other Payer Advanced APM, a payment 
arrangement must meet either the financial risk standard under 
paragraph (d)(1) or (2) of this section and the nominal amount standard 
under paragraph (d)(3) or (4) of this section, make payment using a 
full capitation arrangement under paragraph (d)(6) of this section, or 
be a Medicaid Medical Home Model with criteria comparable to an 
expanded Medical Home Model under section 1115A(c) of the Act.
    (1) Generally applicable financial risk standard. Except for APM 
Entities to which paragraph (d)(2) of this section applies, to be an 
Other Payer Advanced APM, an APM Entity must, based on whether an APM 
Entity's actual expenditures for which the APM Entity is responsible 
under the payment arrangement exceed expected expenditures during a 
specified period of performance do one or more of the following:
* * * * *
    (2) Medicaid Medical Home Model financial risk standard. The APM 
Entity participates in a Medicaid Medical Home Model that, based on the 
APM Entity's failure to meet or exceed one or more specified 
performance standards, does one or more of the following:
* * * * *
    (3) Generally applicable nominal amount standard. Except for 
payment arrangements described in paragraph (d)(2) of this section, the 
total amount an APM Entity potentially owes a payer or foregoes under a 
payment arrangement must be at least:
    (i) For the 2019 and 2020 QP Performance Periods, 8 percent of the 
total combined revenues from the payer to providers and other entities 
under the payment arrangement if financial risk is expressly defined in 
terms of revenue; or
* * * * *
    (4) Medicaid Medical Home Model nominal amount standard. For a 
Medicaid Medical Home Model to meet the Medicaid Medical Home Model 
nominal amount standard, the total annual amount that an APM Entity 
potentially owes a payer or foregoes must be at least the following 
amounts:
    (i) For QP Performance Period 2019, 3 percent of the average 
estimated total revenue of the participating providers or other 
entities under the payer.
    (ii) For QP Performance Period 2020, 4 percent of the average 
estimated total revenue of the participating providers or other 
entities under the payer.
    (iii) For QP Performance Periods 2021 and later, 5 percent of the 
average estimated total revenue of the participating providers or other 
entities under the payer.
* * * * *
    (8) Medicaid Medical Home Model 50 eligible clinician limit. 
Notwithstanding paragraphs (d)(2) and (4) of this section, beginning in 
the 2019 QP Performance Period, if an APM Entity participating in a 
Medicaid Medical Home Model is owned and operated by an organization 
with 50 or more eligible clinicians whose Medicare billing rights have 
been reassigned to the TIN(s) of the organization(s) or any of the 
organization's subsidiary entities, the requirements of paragraphs 
(d)(1) and (3) of this section apply.

0
19. Section 414.1425 is amended by--
0
a. Revising paragraphs (a), (b), (c)(3), (c)(4)(i), and (c)(6);
0
b. Adding paragraph (c)(7); and

[[Page 53962]]

0
c. Revising paragraphs (d)(1) and (4).
    The revisions and addition read as follows:


Sec.  414.1425  Qualifying APM participant determination: In general.

    (a) List used for QP determination. (1) For Advanced APMs in which 
all APM Entities may include eligible clinicians on a Participation 
List, the Participation List is used to identify the APM Entity group 
for purposes of QP determinations, regardless of whether the APM Entity 
may also include eligible clinicians on an Affiliated Practitioner 
List.
    (2) For Advanced APMs in which APM Entities do not include eligible 
clinicians on a Participation List but do include eligible clinicians 
on an Affiliated Practitioner List, the Affiliated Practitioner List is 
used to identify the eligible clinicians for purposes of QP 
determinations.
    (3) For Advanced APMs in which some APM Entities may include 
eligible clinicians on a Participation List and other APM Entities may 
only include eligible clinicians on an Affiliated Practitioner List 
depending on the type of APM Entity, paragraph (a)(1) of this section 
applies to APM Entities that may include eligible clinicians on a 
Participation List, and paragraph (a)(2) of this section applies to APM 
Entities that may only include eligible clinicians on an Affiliated 
Practitioner List.
    (b) Group or individual determination under the Medicare Option. 
(1) APM Entity group determination. Except for paragraphs (b)(2) and 
(3) of this section and as set forth in Sec.  414.1440, for purposes of 
the QP determinations for a year, eligible clinicians are grouped and 
assessed through their collective participation in an APM Entity group 
that is in an Advanced APM. To be included in the APM Entity group for 
purposes of the QP determination, an eligible clinician's APM 
participant identifier must be present on a Participation List of an 
APM Entity group on one of the dates: March 31, June 30, or August 31 
of the QP Performance Period. An eligible clinician included on a 
Participation List on any one of these dates is included in the APM 
Entity group even if that eligible clinician is not included on that 
Participation List at one of the prior or later listed dates. CMS 
performs QP determinations for the eligible clinicians in an APM entity 
group three times during the QP Performance Period using claims data 
for services furnished from January 1 through each of the respective QP 
determination dates: March 31, June 30, and August 31. An eligible 
clinician can only be determined to be a QP if the eligible clinician 
appears on the Participation List on a date (March 31, June 30, or 
August 31) CMS uses to determine the APM Entity group and to make QP 
determinations collectively for the APM Entity group based on 
participation in the Advanced APM.
    (2) Affiliated practitioner individual determination under the 
Medicare Option. For Advanced APMs to which paragraph (a)(2) of this 
section applies, QP determinations are made individually for each 
eligible clinician. To be assessed as an Affiliated Practitioner, an 
eligible clinician must be identified on an Affiliated Practitioner 
List on one of the dates: March 31, June 30, or August 31 of the QP 
Performance Period. An eligible clinician included on an Affiliated 
Practitioner List on any one of these dates is assessed as an 
Affiliated Practitioner even if that eligible clinician is not included 
on the Affiliated Practitioner List at one of the prior or later listed 
dates. For such eligible clinicians, CMS performs QP determinations 
during the QP Performance Period using claims data for services 
furnished from January 1 through each of the respective QP 
determination dates that the eligible clinician is on the Affiliated 
Practitioner List: March 31, June 30, and August 31.
    (c) * * *
    (3) An eligible clinician is a QP for a year under the Medicare 
Option if the eligible clinician is in an APM Entity group that 
achieves a Threshold Score that meets or exceeds the corresponding QP 
payment amount threshold or QP patient count threshold for that QP 
Performance Period as described in Sec.  414.1430(a)(1) and (3). An 
eligible clinician is a QP for the year under the All-Payer Combination 
Option if the eligible clinician individually, or as part of an APM 
Entity group, achieves a Threshold Score that meets or exceeds the 
corresponding QP payment amount threshold or QP patient count threshold 
for that QP Performance Period as described in Sec.  414.1430(b)(1) and 
(3).
    (4) * * *
    (i) The eligible clinician is included in more than one APM Entity 
group and none of the APM Entity groups in which the eligible clinician 
is included meets the QP payment amount threshold or the QP patient 
count threshold, or the eligible clinician is an Affiliated 
Practitioner; and
* * * * *
    (6) Notwithstanding paragraph (c)(4) of this section, an eligible 
clinician is not a QP for a year if one or more of the APM Entities in 
which the eligible clinician participates voluntarily or involuntarily 
terminates from the Advanced APM before the end of the QP Performance 
Period, and the eligible clinician does not individually achieve a 
Threshold Score that meets or exceeds the QP payment amount threshold 
or QP patient count threshold based on participation in the remaining 
non-terminating APM Entities.
    (7) Advanced APMs that start or end during the QP Performance 
Period:
    (i) Notwithstanding paragraph (a) of this section and Sec. Sec.  
414.1435 and 414.1440, CMS makes QP determinations and Partial QP 
determinations for the APM Entity group or individual eligible 
clinician under Sec.  414.1425(b) for Advanced APMs that start or end 
during the QP Performance Period and that are actively tested for 60 or 
more continuous days during the QP Performance Period using claims data 
for services furnished during those dates on which the Advanced APM is 
actively tested. For Advanced APMs that start active testing during the 
QP Performance Period, CMS performs QP and Partial QP determinations 
during the QP Performance Period using claims data for services 
furnished from the start of active testing of the Advanced APM through 
each of the QP determination dates that occur on or after the Advanced 
APM has been actively tested for 60 or more continuous days: March 31, 
June 30, and August 31. For Advanced APMs that end active testing 
during the QP Performance Period, CMS performs QP and Partial QP 
determinations using claims data for services furnished from January 1 
or the start of active testing, whichever occurs later, through the 
final day of active testing of the Advanced APM for each of the QP 
determination dates that occur on or after the Advanced APM has been 
actively tested for 60 or more continuous days during that QP 
Performance Period: March 31, June 30, and August 31.
    (ii) For QP determinations specified under paragraph (c)(4) of this 
section and Partial QP determinations under paragraph (d)(2) of this 
section, QP determinations are made using claims data for the full QP 
Performance Period even if the eligible clinician participates in one 
or more Advanced APMs that start or end during the QP Performance 
Period.
    (d) * * *
    (1) An eligible clinician is a Partial QP for a year under the 
Medicare Option if the eligible clinician is in an APM Entity group 
that achieves Threshold Score that meets or exceeds the corresponding 
Partial QP payment

[[Page 53963]]

amount threshold or Partial QP patient count threshold for that QP 
Performance Period as described in Sec.  414.1430(a)(2) and (4). An 
eligible clinician is a Partial QP for the year under the All-Payer 
Combination Option if the eligible clinician achieves individually, or 
as part of an APM Entity group, a Threshold Score that meets or exceeds 
the corresponding Partial QP payment amount threshold or Partial QP 
patient count threshold for that QP Performance Period as described in 
Sec.  414.1430(b)(2) and (4).
* * * * *
    (4) Notwithstanding paragraph (d)(2) of this section, an eligible 
clinician is not a Partial QP for a year if one or more of the APM 
Entities in which the eligible clinician participates voluntarily or 
involuntarily terminates from the Advanced APM before the end of the QP 
Performance Period, and the eligible clinician does not individually 
achieve a Threshold Score that meets or exceeds the Partial QP payment 
amount threshold or Partial QP patient count threshold based on 
participation in the remaining non-terminating APM Entities.
* * * * *
    20. Section 414.1435 is amended by revising paragraphs (a) 
introductory text, (a)(1) and (2), (b)(1), (b)(3) and (4), and (d) to 
read as follows:


Sec.  414.1435  Qualifying APM participant determination: Medicare 
option.

    (a) Payment amount method. The Threshold Score for an APM Entity or 
eligible clinician is calculated as a percent by dividing the value 
described under paragraph (a)(1) of this section by the value described 
under paragraph (a)(2) of this section.
    (1) Numerator. The aggregate of payments for Medicare Part B 
covered professional services furnished by the APM Entity group to 
attributed beneficiaries during the QP Performance Period.
    (2) Denominator. The aggregate of payments for Medicare Part B 
covered professional services furnished by the APM Entity group to all 
attribution-eligible beneficiaries during the QP Performance Period.
* * * * *
    (b) * * *
    (1) Numerator. The number of attributed beneficiaries to whom the 
APM Entity group furnishes Medicare Part B covered professional 
services or services by a Rural Health Clinic (RHC) or Federally-
Qualified Health Center (FQHC) during the QP Performance Period.
* * * * *
    (3) Unique beneficiaries. For each APM Entity group, a unique 
Medicare beneficiary is counted no more than one time for the numerator 
and no more than one time for the denominator.
    (4) Beneficiaries count multiple times. Based on attribution under 
the terms of an Advanced APM, a single Medicare beneficiary may be 
counted in the numerator or denominator for multiple different APM 
Entity groups.
* * * * *
    (d) Use of methods. CMS calculates Threshold Scores for an APM 
Entity or eligible clinician as provided by Sec.  414.1425(b) under 
both the payment amount and patient count methods for each QP 
Performance Period. CMS then assigns to the eligible clinicians 
included in the APM Entity group or to the eligible clinician the score 
that results in the greater QP status. QP status is greater than 
Partial QP status, and Partial QP status is greater than no QP status.

0
21. Section 414.1440 is amended by revising paragraphs (a)(1)(iii), 
(a)(2), (b), (c), and (d) and adding paragraphs (e) through (g) to read 
as follows:


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

    (a) * * *
    (1) * * *
    (iii) Under Title XIX in a State in which no Medicaid APM or 
Medicaid Medical Home Model that is an Other Payer Advanced APM is 
available.
    (2) Payments and associated patient counts under paragraph 
(a)(1)(iii) of this section are included in the numerator and 
denominator as specified in paragraphs (b)(2) and (3) and paragraphs 
(c)(2) and (3) of this section for an eligible clinician if CMS 
determines that there is at least one Medicaid APM or Medicaid Medical 
Home Model that is an Other Payer Advanced APM available in the county 
where the eligible clinician sees the most patients during the QP 
Performance Period, and that the eligible clinician is not ineligible 
to participate in the Other Payer Advanced APM based on their 
specialty.
    (b) Payment amount method--(1) In general. The Threshold Score for 
either an APM Entity group or eligible clinician will be calculated by 
dividing the value described under the numerator by the value described 
under the denominator as specified in paragraphs (b)(2) and (3) of this 
section.
    (2) Numerator. The aggregate amount of all payments from all 
payers, except those excluded under paragraph (a) of this section, 
attributable to the eligible clinician or to the APM Entity group under 
the terms of all Advanced APMs and Other Payer Advanced APMs during the 
QP Performance Period.
    (3) Denominator. The aggregate amount of all payments from all 
payers, except those excluded under paragraph (a) of this section, made 
to the eligible clinician or to the APM Entity group during the QP 
Performance Period.
    (c) Patient count method--(1) In general. The Threshold Score for 
either an APM Entity group or eligible clinician is calculated by 
dividing the value described under the numerator by the value described 
under the denominator as specified in paragraphs (c)(2) and (3) of this 
section.
    (2) Numerator. The number of unique patients to whom an APM Entity 
group or eligible clinician furnishes services that are included in the 
measures of aggregate expenditures used under the terms of all Advanced 
APMs and Other Payer Advanced APMs during the QP Performance Period.
    (3) Denominator. The number of unique patients to whom the APM 
Entity group or eligible clinician furnishes services under all non-
excluded payers during the QP Performance Period.
    (4) Unique patients. CMS may count a single patient in the 
numerator and/or denominator for multiple different payers.
    (d) QP Determinations under the All-Payer Combination Option. (1) 
CMS performs QP determinations following the QP Performance Period 
using payment amount and/or patient count information submitted from 
January 1 through each of the respective QP determination dates: March 
31, June 30, and August 31. CMS will use data for the same time periods 
for the Medicare and other payer portions of Threshold Score 
calculations under the All-Payer Combination Option.
    (2) An APM Entity may request that CMS make QP determinations at 
the APM Entity level, and an eligible clinician may request that CMS 
make QP determinations at the eligible clinician level. CMS makes QP 
determinations at either the APM Entity or eligible clinician level. 
Eligible clinicians assessed at the eligible clinician level under the 
Medicare Option at Sec.  414.1425(b)(2) will be assessed at the 
eligible clinician level only under the All-Payer Combination Option.
    (3) CMS uses data at the same level for the Medicare and other 
payer portions of Threshold Score calculations under the All-Payer 
Combination Option. When QP determinations are made at the eligible 
clinician level, and if the Medicare Threshold Score for the

[[Page 53964]]

APM Entity group is higher than when calculated for the eligible 
clinician, CMS makes QP determinations using a weighted Medicare 
Threshold Score that are factored into an All-Payer Combination Option 
Threshold Score.
    (e) Information used to calculate Threshold Scores under the All-
Payer Combination Option. (1) An APM Entity or eligible clinician may 
request as set forth in Sec.  414.1445(b)(2) that CMS determine whether 
a payment arrangement in which they participate meets the Other Payer 
Advanced APM criteria and may demonstrate participation in an Other 
Payer Advanced APM determined as a result of a request made in Sec.  
414.1445(a)(1) or (b)(1) in a form and manner specified by CMS.
    (2) To request a QP determination under the All-Payer Combination 
Option, for each payment arrangement submitted as set forth in 
paragraph (e)(1) of this section, the APM Entity or eligible clinician 
must include the amount of revenue for services furnished through the 
payment arrangement, the total revenue received from all payers except 
those excluded as provided in paragraph (a)(2) of this section, the 
number of patients furnished any service through the arrangement, and 
the total number of patients furnished any services, except those 
excluded as provided in paragraph (a)(2) of this section.
    (3) An APM Entity or eligible clinician must submit the information 
specified in paragraph (e)(2) of this section in a form and manner 
specified by CMS. An APM Entity or eligible clinician may submit the 
information specified in paragraph (e)(2) of this section for the 
following periods of time in the relevant QP Performance Period: 
January 1 through March 31, January 1 through June 30, and January 1 
through August 31.
    (4) To request a QP determination under the All-Payer Combination 
Option, an APM Entity or eligible clinician must submit this 
information to CMS no later than the QP Determination Submission 
Deadline, which is December 1 of the calendar year that is 2 years 
prior to the payment year.
    (f) Requirement to submit sufficient information--(1) Sufficient 
Information. CMS makes a QP determination with respect to the eligible 
clinician under the All-Payer Combination Option only if the APM Entity 
or eligible clinician submits the information required under paragraph 
(e) of this section sufficient for CMS to assess the eligible clinician 
under either the payment amount or patient count as described in 
paragraphs (b) and (c) of this section.
    (2) Certification. The APM Entity or eligible clinician who submits 
information to request a QP determination under the All-Payer 
Combination Option must certify that the information submitted to CMS 
is true, accurate, and complete. Such certification must accompany the 
submission and be made at the time of submission. In the case of 
information submitted by an APM Entity, the certification must be made 
by an individual with the authority to bind the APM Entity.
    (g) Notification of QP determination. CMS notifies eligible 
clinicians determined to be QPs or Partial QPs for a year as soon as 
practicable after QP calculations are conducted.

0
22. Section 414.1445 is revised to read as follows:


Sec.  414.1445  Determination of other payer advanced APMs.

    (a) Determination of Medicaid APMs. Beginning in 2018, and each 
year thereafter, at a time determined by CMS, a state, APM Entity, or 
eligible clinician may request, in a form and manner specified by CMS, 
that CMS determine whether a payment arrangement authorized under Title 
XIX is either a Medicaid APM or a Medicaid Medical Home Model that 
meets the Other Payer Advanced APM criteria as set forth in Sec.  
414.1420. A state must submit its request by April 1 of the year prior 
to the relevant QP Performance Period, and an APM Entity or eligible 
clinician must submit its request by November 1 of the year prior to 
the relevant QP Performance Period. CMS will not determine that a 
payment arrangement is a Medicaid APM or Medicaid Medical Home Model 
that meets the Other Payer Advanced APM criteria as set forth in Sec.  
414.1420 for a year after the relevant QP Performance Period.
    (b) Determination of Other Payer Advanced APMs--(1) Payer Initiated 
Other Payer Advanced APM Determination Process. Beginning in 2018, and 
each year thereafter, at a time determined by CMS, a payer with a 
Medicare Health Plan payment arrangement or a payment arrangement 
aligned with a CMS Multi-Payer Model may request, in a form and manner 
specified by CMS, that CMS determine whether a Medicare Health Plan 
payment arrangement or a payment arrangement aligned with a CMS Multi-
Payer Model meets the Other Payer Advanced APM criteria as set forth in 
Sec.  414.1420. A payer with a Medicare Health Plan payment arrangement 
must submit its requests by the annual Medicare Advantage bid deadline 
of the year prior to the relevant QP Performance Period. A payer with 
an arrangement aligned with a CMS Multi-Payer Model must submit its 
requests by June 30 of the year prior to the relevant QP Performance 
Period.
    (2) Eligible clinician initiated Other Payer Advanced APM 
determination process. Except as provided by paragraph (a) of this 
section, at a time specified by CMS, an APM Entity or eligible 
clinician may request that CMS determine whether a payment arrangement 
meets the Other Payer Advanced APM criteria as set forth in Sec.  
414.1420 in a form and manner specified by CMS. An APM Entity or 
eligible clinician must submit requests by December 1 of the calendar 
year of the relevant QP Performance Period.
    (c) Information required for Other Payer Advanced APM 
determinations. (1) In order to make an Other Payer Advanced APM 
determination as set forth in paragraphs (a) and (b) of this section, a 
payer, APM Entity, or eligible clinician must submit the information 
specified by CMS in a form and manner specified by CMS. If a payer, APM 
Entity, or eligible clinician fails to submit the information required, 
CMS will not make a determination as to whether a payment arrangement 
meets the Other Payer Advanced APM criteria as set forth in Sec.  
414.1420.
    (2) If an eligible clinician submits information showing that a 
payment arrangement requires that the eligible clinician must use CEHRT 
as defined in Sec.  414.1305 to document and communicate clinical care, 
CMS will presume that the CEHRT criterion in Sec.  414.1420(b) is 
satisfied for that payment arrangement.
    (3) If a payment arrangement has no outcome measure, the payer, APM 
Entity, or eligible clinician requesting a determination of whether a 
payment arrangement meets the Other Payer Advanced APM criteria must 
certify that there is no available or applicable outcome measure on the 
MIPS measure list.
    (d) Certification. A payer, APM Entity, or eligible clinician that 
submits information pursuant to paragraph (c) of this section must 
certify that the information it submitted to CMS is true, accurate, and 
complete. Such certification must accompany the submission and be made 
at the time of submission. In the case of information submitted by a 
payer or an APM Entity, the certification must be made by an individual 
with the authority to bind the payer or the APM Entity.
    (e) Timing of Other Payer Advanced APM determinations. CMS makes 
Other

[[Page 53965]]

Payer Advanced APM determinations prior to making QP determinations 
under Sec.  414.1440.
    (f) Notification of Other Payer Advanced APM determinations. CMS 
makes Other Payer Advanced APM determinations and notifies the 
requesting payer, APM Entity, or eligible clinician of such 
determinations as soon as practicable following the relevant submission 
deadline.

0
23. Section 414.1460 is amended by revising paragraphs (a) through (e) 
to read as follows:


Sec.  414.1460  Monitoring and program integrity.

    (a) Vetting eligible clinicians. Prior to payment of the APM 
Incentive Payment, CMS determines if eligible clinicians were in 
compliance with all Medicare conditions of participation and the terms 
of the relevant Advanced APMs in which they participated during the QP 
Performance Period. A determination under this provision is not binding 
for other purposes.
    (b) Rescinding QP Determinations. CMS may rescind a QP 
determination if:
    (1) Any of the information CMS relied on in making the QP 
determination was inaccurate or misleading.
    (2) The QP is terminated from an Advanced APM or Other Payer 
Advanced APM during the QP Performance Period or Incentive Payment Base 
Period; or
    (3) The QP is found to be in violation of the terms of the relevant 
Advanced APM or any relevant Federal, State, or tribal statute or 
regulation during the QP Performance Period or Incentive Payment Base 
Period.
    (c) Information submitted for All-Payer Combination Option. 
Information submitted by payers, APM Entities, or eligible clinicians 
for purposes of the All-Payer Combination Option may be subject to 
audit by CMS.
    (d) Reducing, denying, and recouping of APM Incentive Payments. (1) 
CMS may reduce or deny an APM Incentive Payment to an eligible 
clinician.
    (i) Who CMS determines is not in compliance with all Medicare 
conditions of participation and the terms of the relevant Advanced APM 
in which they participate during the QP Performance Period or Incentive 
Payment Base Period;
    (ii) Who is terminated by an APM or Advanced APM during the QP 
Performance Period or Incentive Payment Base Period; or
    (iii) Whose APM Entity is terminated by an APM or Advanced APM for 
non-compliance with any Medicare condition of participation or the 
terms of the relevant Advanced APM in which they participate during the 
QP Performance Period or Incentive Payment Base Period.
    (2) CMS may reopen, revise, and recoup an APM Incentive Payment 
that was made in error in accordance with procedures similar to those 
set forth at Sec. Sec.  405.980 through Sec.  405.986 and Sec. Sec.  
405.370 through 405.379 of this chapter or as established under the 
relevant APM.
    (e) Maintenance of records. (1) A payer that submits information to 
CMS under Sec.  414.1445 for assessment under the All-Payer Combination 
Option must maintain such books, contracts, records, documents, and 
other evidence as necessary to enable the audit of an Other Payer 
Advanced APM determination. Such information and supporting 
documentation must be maintained for a period of 6 years after 
submission.
    (2) An APM Entity or eligible clinician that submits information to 
CMS under Sec.  414.1445 for assessment under the All-Payer Combination 
Option or Sec.  414.1440 for QP determinations must maintain such 
books, contracts, records, documents, and other evidence as necessary 
to enable the audit of an Other Payer Advanced APM determination, QP 
determinations, and the accuracy of APM Incentive Payments for a period 
of 6 years from the end of the QP Performance Period or from the date 
of completion of any audit, evaluation, or inspection, whichever is 
later.
    (3) A payer, APM Entity or eligible clinician that submits 
information to CMS under Sec. Sec.  414.1440 or 414.1445 must provide 
such information and supporting documentation to CMS upon request.
* * * * *

    Dated: October 23, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: October 24, 2017.
Eric D. Hargan,
Acting Secretary, Department of Health and Human Services.
BILLING CODE 4120-01-P

    Editorial note: The following appendix will not appear in the 
Code of Federal Regulations.

Appendix

    Note: For previously finalized MIPS quality measures, we refer 
readers to Table A in the Appendix of the CY 2017 Quality Payment 
Program final rule (81 FR 77558). For previously finalized MIPS 
specialty measure sets, we refer readers to Table E in the Appendix 
of the CY 2017 Quality Payment Program final rule (81 FR 77686). 
Except as otherwise proposed in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30260) and finalized in this final rule, 
previously finalized measures and specialty measure sets will 
continue to apply for the Quality Payment Program year 2 and future 
years.

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    In the CY 2018 Quality Payment Program proposed rule (82 FR 
30010), we proposed to include these additional improvement 
activities in the Improvement Activities Inventory for the Quality 
Payment Program Year 2 and future years based on guidelines 
discussed in the CY 2017 Quality Payment Program final rule at (81 
FR 77190) and finalized in section II.C.6.e.(7)(b) of this final 
rule with comment period. These may include one or more of the 
following criteria:
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcome;
     Importance of an activity that could lead to 
improvement in practice to reduce health care disparities;
     Aligned with patient-centered medical homes;
     Activities that may be considered for an advancing care 
information bonus;
     Representative of activities that multiple individual 
MIPS eligible clinicians or groups could perform (for example, 
primary care, specialty care);
     Feasible to implement, recognizing importance in 
minimizing burden, especially for small practices, practices in 
rural areas, or in areas designated as geographic HPSAs by HRSA;
     CMS is able to validate the activity; or
     Evidence supports that an activity has a high 
probability of contributing to improved beneficiary health outcomes.
BILLING CODE 4120-01-P

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[FR Doc. 2017-24067 Filed 11-2-17; 4:15 pm]
 BILLING CODE 4120-01-C