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

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AGENCY:

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

ACTION:

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

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.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Molly MacHarris, (410) 786-4461, for inquiries related to MIPS.

Benjamin Chin, (410) 786-0679, for inquiries related to APMs.

End Further Info End Preamble Start Supplemental Information

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 SubmissionStart Printed Page 53569

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

D. ICR Regarding Burden for Election of Facility-Based Measurement (§ 414.1380(e))

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

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

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

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

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

J. ICRs Regarding Burden for Cost (§ 414.1350)

K. ICR Regarding Partial QP Elections (§ 414.1430)

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

M. ICRs Regarding Burden for Voluntary Participants To Elect Opt Out of Performance Data Display on Physician Compare (§ 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 Start Printed Page 53570provide 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 Start Printed Page 53571workflows 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 Start Printed Page 53572eligible 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.Start Printed 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 Start Printed Page 53574definition 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.Start Printed 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 Start Printed Page 53576MIPS 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.Start Printed 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 Start Printed Page 53578from 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 § 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 § 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 § 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 § 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 § 414.1310(b)(2) that eligible clinicians (as defined at § 414.1305) who are not MIPS eligible clinicians have the option to voluntarily report measures and activities for MIPS. Additionally, we established at § 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 § 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 Start Printed Page 53579when 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 § 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 § 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 § 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 § 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 Start Printed Page 53580determination 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 Start Printed Page 53581activities 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 Start Printed Page 53582MIPS 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 § 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 QPP@cms.hhs.gov.

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 § 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 Start Printed Page 53583MIPS 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 § 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 § 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.Start Printed Page 53584

Table 1—Percentages of Data Completeness for 60-Day and 30-Day Claims Run Out

Incurred year30-Day claims run out *60-Day claims run out *
201597.1%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 § 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-Start Printed Page 53585patient 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 QPP@cms.hhs.gov. 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 § 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 Start Printed Page 53586under 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 § 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 § 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 § 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 § 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 Start Printed Page 53587at § 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 § 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 § 414.1305 that a QP (as defined at § 414.1305) is not a MIPS eligible clinician, and therefore, is excluded from MIPS. Also, we established that a Partial QP (as defined at § 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 § 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 § 414.1310(b) that for a year, eligible clinicians who do not exceed the low-volume threshold (as defined at § 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 Start Printed Page 53588criterion 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 § 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 § 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 Start Printed Page 53589Secretary 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 § 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 Start Printed Page 53590should 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 Start Printed Page 53591recommendations 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 § 414.1305. However, as provided in § 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 Start Printed Page 53592determinations, 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 § 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 § 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 § 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 § 414.1310(e)(3)).Start Printed 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 § 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 (§ 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 Start Printed Page 53594group; (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 § 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 § 414.1305 or who are excluded from the definition of a MIPS eligible clinician under § 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 § 414.1305) (82 FR 30027). Under § 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 § 414.1305 and who are not excluded from the definition of a MIPS eligible clinician under § 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 § 414.1305 and thus be eligible to form or join a virtual group.

We proposed to define a virtual group at § 414.1305 as a combination of two or more TINs composed of a solo practitioner (that is, a MIPS eligible clinician (as defined at § 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 § 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 Start Printed Page 53595group'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 § 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-Start Printed Page 53596volume 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 § 414.1305 to mean any of the following (excluding those identified at § 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 § 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 § 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 Start Printed Page 53597of 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 § 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 § 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, Start Printed Page 53598which 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 § 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 § 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 § 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 Start Printed Page 53599requirements 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 Start Printed Page 53600policy 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 Start Printed Page 53601increase 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 § 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 § 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 § 414.1315(a) that a solo practitioner (as defined at § 414.1305) or group consisting of 10 or fewer eligible clinicians (as such terms are defined at § 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.Start Printed 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 § 414.1315(a) that a solo practitioner (as defined at § 414.1305) or group consisting of 10 or fewer eligible clinicians (as such terms are defined at § 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 § 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 (§ 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 § 414.1305 and not be excluded from MIPS under § 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 § 414.1305, have a TIN size that does not exceed 10 eligible clinicians, and not be excluded from MIPS under § 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 § 414.1305 or who are excluded from MIPS under § 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):Start Printed Page 53603

  • TINs comprising a virtual group must establish a written formal agreement between each member of a virtual group prior to an election (§ 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 (§ 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: MIPS_VirtualGroups@cms.hhs.gov.
  • 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 (§ 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 (§ 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). Start Printed Page 53604Virtual 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 § 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 § 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 § 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 § 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 § 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 Start Printed Page 53605NPIs, respectively at § 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 § 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 § 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 § 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 § 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 § 414.1315(c)(3)(vii)).
  • Be for a term of at least one performance period as specified in the formal written agreement (at § 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 § 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 § 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 Start Printed Page 53606scope 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 Start Printed Page 53607requirements 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 § 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 Start Printed Page 53608may 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 § 414.1315(c)(3) regarding virtual group agreements. This final rule Start Printed Page 53609with 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 § 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 § 414.1315(c)(3)(i)).
  • Is executed on behalf of each party by an individual who is authorized to bind the party (at § 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 § 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 § 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 § 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 § 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 § 414.1315(c)(3)(vii)).
  • Is for a term of at least one performance period as specified in the formal written agreement (at § 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 § 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 § 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 § 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 § 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 § 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 § 414.1315(d)(4)).
  • Virtual groups would need to adhere to an election process established and required by CMS (at § 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 Start Printed Page 53610determine 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 Start Printed Page 53611party intermediaries would need to meet the same requirements established at § 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 Start Printed Page 53612each 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 Start Printed Page 53613submission 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 § 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 § 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 § 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 § 414.1315(d)(4)).Start Printed Page 53614
  • Virtual groups will need to adhere to an election process established and required by CMS (at § 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 § 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 § 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 § 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.Start Printed 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 Start Printed Page 53616determinants 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.Start Printed 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 Start Printed Page 53618period (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 Start Printed Page 53619performance 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 § 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 § 414.1320(d)(1) and finalizing at § 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 § 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 § 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 § 414.1325(c) and (e).

Table 2—Data Submission Mechanisms for MIPS Eligible Clinicians Reporting Individually

[TIN/NPI]

Performance category/submission combinations acceptedIndividual reporting data submission mechanisms
QualityClaims.
QCDR.
Qualified registry.
EHR.
CostAdministrative claims.1
Advancing Care InformationAttestation.
QCDR.
Qualified registry.
EHR.
Improvement ActivitiesAttestation.
QCDR.
Qualified registry.
EHR.

Table 3—Data Submission Mechanisms for MIPS Eligible Clinicians Reporting as Groups

[TIN]

Performance category/submission combinations acceptedGroup reporting data submission mechanisms
QualityQCDR.
Qualified registry.
EHR.
Start Printed 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).
CostAdministrative claims.1
Advancing Care InformationAttestation.
QCDR.
Qualified registry.
EHR.
CMS Web Interface (groups of 25 or more).
Improvement ActivitiesAttestation.
QCDR.
Qualified registry.
EHR.
CMS Web Interface (groups of 25 or more).

We finalized at § 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.

We proposed to revise § 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 § 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.Start Printed 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 Start Printed Page 53622with 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 Start Printed Page 53623feasibility 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 Start Printed Page 53624recommended 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 Start Printed Page 53625performance 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 § 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 Start Printed Page 53626category. 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 § 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 § 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 § 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 § 414.1330(b) that, for MIPS payment years 2019 and 2020, 60 percent and 50 percent, respectively, of Start Printed Page 53627the 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 § 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 § 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 § 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. Start Printed Page 53628Therefore, 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 § 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 § 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 § 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 § 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 § 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 § 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 § 414.1335(a)(2) the following criteria for the submission of data on quality measures by registered groups of 25 or more eligible clinicians Start Printed Page 53629who 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 § 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 § 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 § 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 § 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 § 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 § 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 Start Printed Page 53630CAHPS 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 Start Printed Page 53631deadline. 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 Start Printed Page 53632as 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 § 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 § 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 § 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 § 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 § 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 Start Printed Page 53633scope 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:

  • § 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
  • § 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:

  • § 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, Start Printed Page 53634regardless of payer for MIPS payment year 2021; and
  • § 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 § 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 § 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

Performance periodClinician typeSubmission mechanismSubmission criteriaData completeness
Jan 1-Dec 31Individual MIPS eligible cliniciansPart B ClaimsReport at least six measures including one outcome measure, or if an outcome measure is not available report another high priority measure; if less than six measures apply then 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 rule60 percent of individual MIPS eligible clinician's Medicare Part B patients for the performance period.
Jan 1-Dec 31Individual MIPS eligible clinicians, groupsQCDR, Qualified Registry, & EHRReport at least six measures including one outcome measure, or if an outcome measure is not available report another high priority measure; if less than six measures apply then report on each measure 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 rule60 percent of individual MIPS eligible clinician's, or group's patients across all payers for the performance period.
Jan 1-Dec 31GroupsCMS Web InterfaceReport on all measures included in the CMS Web Interface; AND populate data fields for the first 248 consecutively ranked and assigned Medicare beneficiaries in the order in which they appear in the group's sample for each module/measure. If the pool of eligible assigned beneficiaries is less than 248, then the group would report on 100 percent of assigned beneficiariesSampling requirements for the group's Medicare Part B patients.
Jan 1-Dec 31GroupsCAHPS for MIPS SurveyCMS-approved survey vendor would need to be paired with another reporting mechanism to ensure the minimum 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 categorySampling requirements for the group's Medicare Part B patients.

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 Start Printed Page 53635each 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 § 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 Start Printed Page 53636measures 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 § 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 Start Printed Page 53637recommendations 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 Start Printed Page 53638apply 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 Start Printed Page 53639based 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 Start Printed Page 53640which 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.Start Printed 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 § 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 § 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 § 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 Start Printed Page 53642clinician 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 Start Printed Page 53643measures 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 § 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 Start Printed Page 53644measures 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 Start Printed Page 53645calculating 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 Start Printed Page 53646the 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 Start Printed Page 53647care 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 Start Printed Page 53648on 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 § 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 § 414.1355 that the improvement activities performance category would account for 15 percent of the final score. We also finalized at § 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 § 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 § 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 § 414.1380 an expanded definition of what is acceptable for recognition as a certified-Start Printed Page 53649patient 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 § 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 § 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® 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 § 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 § 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 § 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 Start Printed Page 53650current 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 Start Printed Page 53651status 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 § 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 § 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 § 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 Start Printed Page 53652improvement 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 § 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 § 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 § 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 § 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.

In the CY 2018 QPP proposed rule (82 FR 30054 through 55) we invited public comments on our proposals to revise § 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 § 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 Start Printed Page 536532017 (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 Start Printed Page 53654medical 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 § 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 § 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 § 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 Start Printed Page 53655such 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 § 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 § 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 § 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 § 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 § 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 Start Printed Page 53656performance 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 § 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 § 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 § 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 § 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 § 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 § 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 Start Printed Page 53657Table 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 Start Printed Page 53658improvement 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 § 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 Start Printed Page 53659clinicians 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 Start Printed Page 53660submitting 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 Start Printed Page 53661used 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 proce