Skip to Content

Proposed Rule

Medicare Program; CY 2018 Updates to the Quality Payment Program

Comments on this document are being accepted at Regulations.gov. Submit a formal comment

Read the 210 public comments

Document Details

Information about this document as published in the Federal Register.

Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble Start Printed Page 30010

AGENCY:

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

ACTION:

Proposed rule.

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 rule provides proposed updates for the second and future years of the Quality Payment Program.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 21, 2017.

ADDRESSES:

In commenting, please refer to file code CMS-5522-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5522-P, P.O. Box 8013, Baltimore, MD 21244-8013.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5522-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period:

a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members. Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

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

II. Provisions of the Proposed Regulations

A. Introduction

B. Definitions

C. MIPS Program Details

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

III. Collection of Information Requirements

IV. Response to Comments

V. Regulatory Impact Analysis

A. Statement of Need

B. Overall Impact

C. Changes in Medicare Payments

D. Impact on Beneficiaries

E. Regulatory Review Costs

F. Accounting Statement

Acronyms

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

ABCTM Achievable Benchmark of Care

ACO Accountable Care Organization

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 Clinician Quality Measure

ED Emergency Department

EHR Electronic Health Record

EP Eligible Professional

ESRD End-Stage Renal Disease

FFS Fee-for-Service

FR Federal Register

FQHC Federally Qualified Health Center

GAO Government Accountability Office

HIE Health Information Exchange

HIPAA Health Insurance Portability and Accountability Act of 1996

HITECH Health Information Technology for Economic and Clinical Health

HPSA Health Professional Shortage Area

HHS Department of Health & Human Services

HRSA Health Resources and Services Administration

IHS Indian Health Service

IT Information Technology

LDO Large Dialysis Organization

MACRA Medicare Access and CHIP Reauthorization Act of 2015

MEI Medicare Economic Index

MIPAA Medicare Improvements for Patients and Providers Act of 2008

MIPS Merit-based Incentive Payment System

MLR Minimum Loss Rate

MSPB Medicare Spending per Beneficiary

MSR Minimum Savings Rate

MUA Medically Underserved Area

NPI National Provider Identifier

OCM Oncology Care Model

ONC Office of the National Coordinator for Health Information Technology

PECOS Medicare Provider Enrollment, Chain, and Ownership System

PFPMs Physician-Focused Payment Models

PFS Physician Fee Schedule

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 ScaleStart Printed Page 30011

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 proposed rule would make 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), to reauthorize the Children's Health Insurance Program, 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).

These policies are collectively referred to as the Quality Payment Program. Recognizing that the Quality Payment Program represents a major milestone in the way that we bring quality measurement and improvement together with payment, we have taken efforts to review existing policies to identify how to move the program forward in the least burdensome manner possible. 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 technology that allows clinicians to focus on providing high quality healthcare for their patients. We believe our existing APMs alongside the proposals in this proposed rule provide opportunities that support state flexibility, local leadership, regulatory relief and innovative approaches to improve quality accessibility and affordability. By driving changes in how care is delivered, we believe the Quality Payment Program supports eligible clinicians in improving the health of their patients and increasing care efficiency. To implement this vision, the Quality Payment Program emphasizes high-value care and patient outcomes while minimizing burden on eligible clinicians; the Program is also designed to be flexible, transparent, and structured to improve over time with input from clinicians, patients, and other stakeholders. We have sought and continue to seek feedback from the health care community through various public avenues such as rulemaking, listening sessions and stakeholder engagement. Last year, when we engaged in rulemaking to establish policies for effective implementation of the Quality Payment Program, we did so with the explicit understanding that technology, infrastructure, physician support systems, and clinical practices will change over the next few years. For more information, see 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), hereinafter referred to as the “CY 2017 Quality Payment Program final rule.” In addition, we are aware of the diversity among clinician practices in their experience with quality-based payments. As a result of these factors, we expect the Quality Payment Program to evolve over multiple years in order to achieve our national goals. To date, we have laid the groundwork for expansion toward an innovative, outcome-focused, patient-centered, resource-effective health system that leverages health information technology to support clinicians and patients and builds collaboration across care settings. This proposed rule is the next part of a staged approach to develop policies that are reflective of system capabilities and grounded in our core strategies to drive progress and reform efforts. We commit to continue evolving these policies.

CMS strives to put patients first, ensuring that they can make decisions about their own healthcare along with their clinicians. We want to ensure innovative approaches to improve quality, accessibility and affordability while paying particular attention to improving clinicians and beneficiaries experience when interacting with CMS programs. The Quality Payment Program aims to (1) support care improvement by focusing on better outcomes for patients, decreased clinician burden, and preservation of independent clinical practice; (2) promote adoption of APMs that align incentives for high-quality, low-cost care across healthcare stakeholders; and (3) advance 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.

We previously finalized the transition year Quality Payment Program policies in the CY 2017 Quality Payment Program final rule. In that final rule, we implemented policies to improve physician and other clinician payments by changing the way Medicare incorporates quality measurement into payments and by developing new policies to address and incentivize participation in APMs. The final rule established the Quality Payment Program and its two interrelated pathways: Advanced APMs, and the MIPS. The final rule established incentives for participation in Advanced APMs, supporting the goals of transitioning from fee-for-service (FFS) payments to payments for quality and value, including approaches that focus on better care, smarter spending, and healthier people. The final rule included definitions and processes to identify Qualifying APM Participants (QPs) in Advanced APMs and outlined 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 final rule also established policies to implement MIPS, a program for certain eligible clinicians that makes Medicare payment adjustments based on performance on quality, cost and other measures and activities, and that consolidates components of three precursor programs—the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for eligible professionals (EPs). As prescribed by MACRA, MIPS focuses on the following: quality—including a set of evidence-based, specialty-specific standards; cost; practice-based improvement activities; and use of certified electronic health record (EHR) technology (CEHRT) to support interoperability and advanced quality objectives in a single, cohesive program that avoids redundancies.

In this proposed rule, we are building and improving Quality Payment Program policies that will be familiar to stakeholders and are designed to integrate easily across clinical practices during the second and future years of implementation. We strive to continue our focus on priorities that can drive improvements toward better patient outcomes without creating undue Start Printed Page 30012burden for clinicians. In this proposed rule, we also address elements of MACRA that were not included in the first year of the program, including virtual groups, facility-based measurement, and improvement scoring. We also include proposals to continue implementing elements of MACRA that do not take effect in the first or second year of the Quality Payment Program, including policies related to the All-Payer Combination Option for identifying QPs and assessing eligible clinicians' participation in Other Payer Advanced APMs. To provide unity and consistency across the two paths of the Quality Payment Program, MIPS and APMs, in this proposed rule we have referred to the second year of the program as “Quality Payment Program Year 2.”

B. Quality Payment Program Strategic Objectives

As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77010), after extensive outreach with clinicians, patients and other stakeholders, we created six strategic objectives to drive continued progress and improvement. These objectives guided our final policies and will guide our future rulemaking in order to design, implement, and evolve a Quality Payment Program that aims to improve health outcomes, promote 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 Advanced APMs; (4) to promote program understanding and maximize participation through customized communication, education, outreach and support that meet the needs of the diversity of physician practices and patients, especially the unique needs of small practices; (5) to improve data and information sharing to provide accurate, timely, and actionable feedback to clinicians and other stakeholders; and (6) to promote IT systems capabilities that meet the needs of users and are seamless, efficient and valuable on the front and back-end. We also believe it is important to ensure the Quality Payment Program maintains operational excellence as the program develops. Therefore we are adding a seventh objective, specifically to ensure operational excellence in program implementation and ongoing development. More information on these objectives and the Quality Payment Program can be found at www.qpp.cms.gov.

With these objectives, we recognize that the Quality Payment Program provides new opportunities to improve care delivery by supporting and rewarding clinicians as they find new ways to engage patients, families, and caregivers and to improve care coordination and population health management. In addition, we recognize that by developing a program that is flexible instead of one-size-fits-all, clinicians will be able to choose to participate in a way that is best for them, their practice, and their patients. For eligible clinicians interested in APMs, we believe that by setting ambitious yet achievable goals, eligible clinicians will move with greater certainty toward these new approaches of delivering care. APMs are a vital part of bending the Medicare cost curve by encouraging the delivery of high-quality, low-cost care. To these ends, and 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, 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 workflows can best be accomplished by making connections across the four statutory pillars of the MIPS incentive structure—quality, clinical practice improvement activities (referred to as “improvement activities”), meaningful use of CEHRT (referred to as “advancing care information”), and resource use (referred to as “cost”)—and by emphasizing that the Quality Payment Program is at its core about improving the quality of patient care.

Although there are two separate pathways within the Quality Payment Program, the Advanced APM and MIPS tracks 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, and the MIPS builds the capacity of eligible clinicians across the four pillars of MIPS to prepare them for participation in MIPS APMs and Advanced 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 quality, not only through evidence-based quality measures, but also by accounting for activities that clinicians themselves identify: namely, practice-driven quality improvement. MIPS also requires us to assess whether CEHRT is used meaningfully. 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. The cost performance category was simplified and weighted at zero percent of the final score for the transition year of CY 2017 to allow clinicians an opportunity to ease into the Quality Payment Program. We further note the cost performance category requires no separate submissions for participation which minimizes burden on clinicians. The assessment of cost is a vital part of ensuring that clinicians are providing Medicare beneficiaries with high-value care. Given the primary focus on value, we indicated in the CY 2017 Quality Start Printed Page 30013Payment Program final rule our intention to align cost measures with quality measures over time in the scoring system (81 FR 77010). That is, we established special policies for the first year of the Quality Payment Program, which enabled a ramp-up and gradual transition with less financial risk for clinicians in the transition year. We called this approach “pick your pace” and allowed clinicians and groups to participate in MIPS through flexible means while avoiding a negative payment adjustment. In this proposed rule, we continue the slow ramp-up of the Quality Payment Program by establishing special policies for Program 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).

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. This trajectory provides to clinicians the ability to participate in the program through two pathways: MIPS and Advanced APMs. As we indicated in the CY 2017 Quality Payment Program final rule (81 FR 77011), we believed that a second transition period would be necessary to build upon the iterative learning and development period as we build towards a steady state. We continue to believe this to be true and have therefore crafted our policies to extend flexibilities into Quality Payment Program Year 2.

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. For MIPS performance periods occurring in 2017, many small practices are excluded from new requirements due to the low-volume threshold, which was set 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, however, from many small practices that challenges still exist in their ability to participate in the program. We are proposing additional flexibilities 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; 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.

As discussed in section V.C. of this proposed rule, 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. We estimate that at least 80 percent of clinicians in small practices with 1-15 clinicians will receive a positive or neutral MIPS payment adjustment. We refer readers to section V.C. of this proposed rule for details on how this estimate was developed.

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. APMs that meet the criteria to be Advanced APMs provide the pathway through which eligible clinicians, who would otherwise fall under the MIPS, can become Qualifying APM Participants (QPs), thereby earning incentive payments for their Advanced APM participation. In the CY 2017 Quality Payment Program final rule (81 FR 77516), 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. With new Advanced APMs expected to be available for participation in 2018, including the Medicare ACO Track 1 Plus (1+) Model, and the reopening of the application process to new participants for some current Advanced APMs, such as the Next Generation ACO Model and Comprehensive Primary Care Plus Model, we anticipate higher numbers of QPs in subsequent years of the program. We currently estimate that approximately 180,000 to 245,000 eligible clinicians may become QPs for payment year 2020 based on Advanced APM participation in performance year 2018.

b. Advanced APMs

In the CY 2017 Quality Payment Program final rule (81 FR 77408), 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.

We are proposing to maintain the generally applicable revenue-based nominal amount standard at 8 percent of the estimated average total Parts A and B revenue of eligible clinicians in participating APM Entities for QP Performance Periods 2019 and 2020.

c. Qualifying APM Participant (QP) and Partial QP Determination

QPs are eligible clinicians in an Advanced APM who have met a threshold for a certain percentage of their patients or payments through an Advanced APM. QPs are excluded from MIPS for the year, and receive a 5 percent APM Incentive Payment for each year they are QPs beginning in 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. For Advanced APMs that start or end during the Medicare QP Performance Period and operate Start Printed Page 30014continuously for a minimum of 60 days during the Medicare QP Performance Period for the year, we are proposing to make 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 Medicare 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.

d. All-Payer Combination Option

The All-Payer Combination Option, which uses a calculation based on both the Medicare Option and the eligible clinician's participation in Other Payer Advanced APMs to conduct 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 identify 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 other payer arrangements are Other Payer Advanced APMs and 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.

We are proposing modifications pertaining to the third criterion that 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. Specifically, we are proposing to add a revenue-based nominal amount standard in addition to the benchmark-based nominal amount standard that would be applicable only to payment arrangements in which risk is expressly defined in terms of revenue.

We are proposing modifications to our methodologies to determine whether eligible clinicians will meet the QP thresholds using the All-Payer Combination Option. Specifically, we are proposing to conduct all QP determinations under the All-Payer Combination Option at the individual eligible clinician level and are seeking comment on any possible exceptions to this proposed policy that would be warranted, such as a determination based on APM Entity group performance under the All-Payer Combination Option for eligible clinicians participating in CMS Multi-Payer Models. We are also proposing to establish an All-Payer QP Performance Period to assess participation in Other Payer Advanced APMs under the All-Payer Combination Option, and to rename the QP Performance Period we established in rulemaking last year as the Medicare QP Performance Period.

We are proposing to modify the information submission requirements for the All-Payer Combination Option. Specifically, we are proposing modifications to the information we require to make APM Entity or eligible clinician initiated determinations of Other Payer Advanced APMs after the All-Payer QP Performance Period, as well as the information we require to perform QP determinations under the All-Payer Combination Option. We are also proposing policies on the handling of information submitted for purposes of assessment under the All-Payer Combination Option.

We are proposing a Payer Initiated Other Payer Advanced APM Determination Process, which would allow certain other payers, including payment arrangements authorized under Title XIX, Medicare Health Plans, and payers with payment arrangements in CMS Multi-Payer Models, to request that we determine whether their other payer arrangements are Other Payer Advanced APMs starting prior to the 2019 All-Payer QP Performance Period and each year thereafter.

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. PTAC comments and recommendations will be reviewed by the CMS Innovation Center and the Secretary, and we will post a detailed response to them on the CMS Web site. We are seeking 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. This broadened definition might be more inclusive of potential PFPMs that could focus on areas not generally applicable to the Medicare population, and could engage more stakeholders in designing PFPMs. In addition, as we gain experience with public submission of PFPM proposals to the PTAC, we are seeking comments on the Secretary's criteria and stakeholders' needs in developing PFPM proposals aimed at meeting the criteria.

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 performance periods in 2018 and the 2020 MIPS payment year, we are proposing the following policies:

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). For the 2020 MIPS payment year, now we are proposing to maintain a 60 percent weight for the quality performance category contingent upon our proposal to reweight the cost performance category to zero for the 2020 MIPS payment year as discussed in section II.C.6.b.(2) in this proposed rule. Quality measures are selected annually through a call for quality measures, and a final list of quality measures will be published in the Federal Register by November 1 of each year. Except as discussed in section II.C.6.b.(3)(a)(iii) of this proposed rule with regard to the Start Printed Page 30015CAHPS for MIPS survey, we are not proposing any changes to the submission criteria for quality measures in this proposed rule. We are proposing for the CAHPS for MIPS survey 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. In addition, we are proposing for the Quality Payment Program Year 2 and future years to remove two Summary Survey Modules (SSM), 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. We noted that these thresholds for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims would increase for performance periods occurring in 2019 and future years. However, as discussed in section II.C.6.b. of this proposed rule, we are proposing for the 2018 MIPS performance period to maintain the transition year data completeness threshold of 50 percent for data submitted on quality measures using QCDRs, qualified registries, EHR, or Medicare Part B claims to provide an additional year for individual MIPS eligible clinicians and groups to gain experience with the MIPS before increasing the data completeness threshold. However, we are proposing to increase the data completeness threshold for the 2021 MIPS payment year to 60 percent for data submitted on quality measures using QCDRs, qualified registries, EHR, or Medicare Part B claims. We anticipate that for performance periods going forward, as MIPS eligible clinicians gain experience with the MIPS, we would further increase these thresholds over time.

b. Improvement Activities

Improvement activities are those that support broad aims within healthcare delivery, including care coordination, beneficiary engagement, population management, and health equity. In response to comments from experts and stakeholders across the healthcare system, improvement activities were given relative weights of high and medium. 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). For performance periods occurring in 2018, we are not proposing any changes in improvement activities scoring as discussed in the CY 2017 Quality Payment Program final rule (81 FR 77312).

As discussed in the appendices of this proposed rule, we are proposing new improvement activities (Table F) and improvement activities with changes (Table G) for the 2018 MIPS performance period and future years for inclusion in the Improvement Activities Inventory. Activities proposed in this section would apply for the 2018 MIPS performance period and future performance periods unless further modified via notice and comment rulemaking. We refer readers to Table H of the CY 2017 Quality Payment Program final rule for a list of all the previously finalized improvement activities (81 FR 77817 through 77831).

As discussed in section II.C.6.e.3.(c) of this proposed rule, we are proposing to expand our definition of how we will recognize an individual MIPS eligible clinician or group as being a certified patient-centered medical home or comparable specialty practice. We finalized at § 414.1380(b)(3)(iv) in the CY 2017 Quality Payment Program final rule that a certified patient-centered medical home includes practice sites with current certification from a national program, regional or state program, private payer or other body that administers patient-centered medical home accreditation. We are proposing in section II.C.6.e.(3)(b) of this proposed rule 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. In addition, for group reporters, for the 2018 MIPS performance period and future performance periods, we are proposing to require that at least 50 percent of the practice sites within a TIN must be recognized as a certified or recognized patient-centered medical home or comparable specialty practice to receive full credit in the improvement activities performance category.

As discussed in section II.C.6.f.(2)(d) of this proposed rule, in recognition of improvement activities as supporting the central mission of a unified Quality Payment Program, we propose 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 comprises 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 comprise 30 percent or 75 percent of the final score depending on the availability of APM quality data for reporting. Objectives and measures in the advancing care information performance category focus on the secure exchange of health information and the use 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 proposing that MIPS eligible clinicians may continue to use EHR technology certified to the 2014 Edition for the performance period in CY 2018. We are proposing minor modifications to the advancing care information objectives and measures and the 2017 advancing care information transition objectives and measures. We are also proposing to add an exclusion for the e-Prescribing and Health Information Exchange Objectives. We are proposing to modify our scoring policy for the Public Health and Clinical Data Registry Reporting Objectives and Measures for the performance score and the bonus score.

We are also proposing to implement 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 proposing to add a significant hardship exception for MIPS eligible clinicians in small practices.

d. Cost

In this proposed rule, we are proposing to weight the cost performance category at zero percent of the final score for the 2020 MIPS payment year in order to improve clinician understanding of the measures Start Printed Page 30016and continue development of episode-based measures that will be used in this performance category.

For the 2018 MIPS performance period, we are proposing to adopt for the cost performance category 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. For the 2018 MIPS performance period, we are not proposing to 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 intend to provide feedback on these new episode-based cost measures in the fall of this year 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 another set of newly developed episode-based cost measures in 2018 as well. Therefore, clinicians would have received feedback on cost measures at several points prior to the cost performance category counting as part of the final score.

e. Submission Mechanisms

As discussed in section II.6.a. of this proposed rule, we are proposing additional flexibility for submitting data. Individual MIPS eligible clinicians or groups would 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. We expect that this option will provide clinicians the ability to select the measures most meaningful to them, regardless of the submission mechanism.

f. Virtual Groups

There are generally three ways to participate in MIPS: (1) As an individual; (2) as a group; and (3) as a virtual group. In this proposed rule, we are proposing to establish requirements for MIPS participation at the virtual group level. We propose to define a virtual group as a combination of two or more TINs composed of a solo practitioner (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 (as defined at § 414.1305) with 10 or fewer eligible clinicians 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.

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 can access the TA infrastructure that they may be already utilizing. For Quality Payment Program Year 3, we intend to provide an electronic election process if technically feasible. Clinicians who do not elect to contact their designated TA representative would still have the option of contacting the Quality Payment Program Service Center. We believe that our proposal will create an election process that is simple and straightforward.

g. MIPS APMs

In the CY 2017 Quality Payment Program final rule (81 FR 77246), we finalized that MIPS eligible clinicians who participate in MIPS APMs will be scored using the APM scoring standard instead of the generally applicable MIPS scoring standard. For the 2018 performance period, we are proposing modifications to the quality performance category reporting requirements and scoring for MIPS eligible clinicians in most MIPS APMs, and other modifications to the APM scoring standard. For purposes of the APM scoring standard, we are proposing to add a fourth snapshot date that would be used only to identify APM Entity groups participating in those MIPS APMs that require full TIN participation. 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 the CY 2017 Quality Payment Program final rule (81 FR 77246).

h. Facility-Based Measurement

For the transition year of MIPS, we considered an option for facility-based MIPS eligible clinicians to elect to use their institution's performance rates as a proxy for the MIPS eligible clinician's performance in the quality and cost performance categories. However, we did not propose an option for the transition year of MIPS because there were several operational considerations that needed to be addressed before this option could be implemented. After consideration of comments received on the CY 2017 Quality Payment Program proposed rule (81 FR 28192) and other comments received, we have decided to implement facility-based measures 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. As discussed in section II.C.7.b. of this proposed rule, we are proposing 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 present 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. While we propose to limit that opportunity to clinicians who practice primarily in the hospital, we seek to expand the program to other value-based payment programs as appropriate in the future. We discuss that new method of scoring in section II.C.7.b.(4) of this proposed rule.

i. Scoring

In the CY 2017 Quality Payment Program final rule, 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 propose to build on the scoring methodology we finalized for the transition year, focusing on encouraging MIPS eligible clinicians to meet data completeness requirements.

For quality performance category scoring, we are proposing to extend some of the transition year policies to the 2018 MIPS performance period and are also proposing several modifications to existing policy. For the 2018 MIPS performance period, we are proposing to maintain the 3 point floor for measures that can be reliably scored against a benchmark. We are also proposing, to maintain the policy to assign 3 points to measures that are submitted but do not have a benchmark or do not meet the case minimum, which does not apply to the CMS Web Interface measures and administrative claims based measures. For the 2018 MIPS performance period, we are also proposing to lower the number of points available for measures that do not meet the data completeness Start Printed Page 30017criteria, except for a measure submitted by a small practice, which we propose to continue to assign 3 points if the measure does not meet data completeness. This does not apply to CMS Web Interface measures or administrative claims based measures.

Beginning with the 2018 MIPS performance period, we are proposing to add performance standards for scoring improvement for the quality and cost performance categories. We are also proposing a systematic approach to address topped out quality measures.

For the 2018 MIPS performance period, we are proposing that 3 performance category scores (quality, improvement activities, and advancing care information) would be given weight in the final score, or be reweighted if a performance category score is not available. We are also proposing to add final score bonuses for small practices and for MIPS eligible clinicians that care for complex patients.

We are also proposing that the final score will be compared against a MIPS performance threshold of 15 points, which can be achieved via multiple pathways and continues the gradual transition into MIPS.

j. Performance Feedback

We are proposing to provide Quality Payment Program performance feedback to eligible clinicians and groups. Initially, we would 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. Targeted Review Process

In the CY 2017 Quality Payment Program final rule (81 FR 77353), we finalized a targeted review process under MIPS wherein a MIPS eligible clinician or group may request that we review the calculation of the MIPS payment adjustment factor and, as applicable, the calculation of the additional MIPS payment adjustment factor applicable to such MIPS eligible clinician or group for a year. We are not proposing any changes to this process for the second year of the MIPS.

l. Third Party Intermediaries

We believe that third party intermediaries that collect or submit data on behalf of individual eligible clinicians and groups participating in MIPS and allowing for flexible reporting options, will provide individual MIPS eligible clinicians and groups with options to accommodate different practices and make measurement meaningful. 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. As discussed in section II.C.10.a.(3) of this proposed rule, we propose 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 performance periods occurring in 2018. We are proposing, beginning with the 2019 performance period, a simplified process in which existing QCDRs or qualified registries in good standing may continue their participation in MIPS by attesting that their approved data validation plan, cost, approved QCDR measures (applicable to QCDRs only), MIPS quality measures, activities, services, and performance categories offered in the previous year's performance period of MIPS have no changes. QCDRs and qualified registries in good standing, may also make substantive or minimal changes to their approved self-nomination application from the previous year of MIPS that would be submitted during the self-nomination period for CMS review and approval. By attesting that certain aspects of their application will remain the same, as approved from the previous year, existing QCDRs in good standing and qualified registries will be spending less time completing the self-nomination application, as was previously required. This process will be conducted on an annual basis.

In addition, we are proposing that the term “QCDR measures” replace the term “non-MIPS measures,” without proposing any changes to the definition, criteria, or requirements that were finalized in the CY 2017 Quality Payment Program final rule (81 FR 77375). We are not proposing any changes to the health IT vendors that obtain data from CEHRT requirements.

Lastly, we are proposing for future program years, beginning with performance periods occurring in 2018 that we remove the April 30th survey vendor application deadline. We are proposing for the Quality Payment Program Year 2 and future years that the vendor application deadline be January 31st of the applicable performance year or a later date specified by CMS. We will notify vendors of the application deadline, to become a CMS-approved survey vendor through additional communications and postings.

m. Public Reporting

As discussed in section II.C.11. of this proposed rule, we are proposing 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.

n. Eligibility and Exclusion Provisions of the MIPS Program

In section II.C.1.f. of this proposed rule, we are proposing to modify the definition of a non-patient facing MIPS eligible clinician to apply to virtual groups. We are also proposing 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. Additionally, in section II.C.3.c. of this proposed rule, we are proposing to modify the low-volume threshold policy established in the CY 2017 Quality Payment Program final rule. As discussed in section II.C.3.c of this proposed rule, we believe that increasing the low-volume threshold to less than or equal to $90,000 in Medicare Part B charges or 200 or fewer Part-B enrolled Medicare beneficiaries would further decrease burden on MIPS eligible clinicians that practice in rural areas or are part of a small practice or are solo practitioners.

E. Payment Adjustments

As discussed in section V.C. of this proposed rule, for the 2020 payment year based on Advanced APM participation in 2018 performance period, we estimate that approximately 180,000 to 245,000 clinicians will become QPs, and therefore be exempt from MIPS and qualify for lump sum incentive payments based on 5 percent of their Part B allowable charges for covered professional services. We estimate that the total lump sum incentive payments will be between approximately $590 and $800 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 ACO Track 1+ which is projected to have a large number of participants, with a large majority reaching QP status.Start Printed Page 30018

Under the policies in this proposed rule, we estimate that approximately 572,000 eligible clinicians would be required to participate in MIPS in the 2018 MIPS performance period, although 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, the proposed increase in the low-volume threshold is expected to exclude 585,560 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 three integrated performance categories; the fourth category of cost, as previously outlined, would be weighted to zero in the 2020 MIPS payment year. Assuming that 90 percent of 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 ($173 million) and positive MIPS payment adjustments ($173 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 Proposed Rule

The Quality Payment Program may result in quality improvements and improvements to the patients' experience of care as MIPS eligible clinicians respond to the incentives for high-quality care provided by MIPS and implement care quality improvements in their clinical practices.

We also quantify several costs associated with this rule. We estimate that this proposed rule will result in approximately $857 million in collection of information-related burden. We estimate that the incremental collection of information-related burden associated with this proposed rule is approximately $12.4 million relative to the estimated burden of continuing the policies the CY 2017 Quality Payment Program final rule, which is $869 million. We also estimate regulatory review costs of $4.8 million for this proposed rule, comparable to the regulatory review costs of the CY 2017 Quality Payment Program proposed rule. We estimate that federal expenditures will include $173 million in revenue neutral payment adjustments and $500 million for exceptional performance payments. Additional federal expenditures include approximately $590-$800 million in APM incentive payments to QPs.

G. Stakeholder Input

In developing this proposed rule, we sought feedback from stakeholders and the public throughout the process, including in the CY 2017 Quality Payment Program final rule with comment period, listening sessions, webinars, and other listening venues. We received a high degree of interest from a broad spectrum of stakeholders. We thank our many commenters and acknowledge their valued input throughout the rulemaking process. We discuss the substance of relevant comments in the appropriate sections of this proposed rule, though we were not able to address all comments or all issues that all commenters brought forth due to the volume of comments and feedback. In general, commenters continue to support establishment of the Quality Payment Program and maintain optimism as we move from pure FFS Medicare payment towards an enhanced focus on the quality and value of care. Public support for our proposed approach and policies in the proposed rule focused on the potential for improving the quality of care delivered to beneficiaries and increasing value to the public—while rewarding eligible clinicians for their efforts.

We thank stakeholders again for their considered 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.

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

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 proposed updates for the second and future years of the Quality Payment Program.

B. Definitions

At § 414.1305, subpart O, we propose to define the following terms:

  • All-Payer QP Performance Period.
  • Ambulatory Surgical Center (ASC)-based MIPS eligible clinician.
  • CMS Multi-Payer Model.
  • Full TIN APM.
  • Improvement Scoring.
  • Medicare QP Performance Period.
  • Other MIPS APM.
  • Virtual group.

We propose to 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.

We propose to remove the following terms:

Start Printed Page 30019
  • Advanced APM Entity.
  • QP Performance Period.

These terms and definitions are discussed in detail in relevant sections of this proposed rule.

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 when Part B items or services are rendered 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 where the supplier may also be a MIPS eligible clinician. In circumstances in which a MIPS eligible clinician 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 durable medical equipment 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 allowable 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. For Part B items and services furnished by a MIPS eligible clinician such as purchasing and administering Part B drugs that are billed by the MIPS eligible clinician, such items and services may be subject to MIPS adjustment based on the MIPS eligible clinician's performance during the applicable performance period or included for eligibility determinations. For those billed Medicare Part B allowable charges relating to the purchasing and administration of Part B drugs that we are able to associate with a MIPS eligible clinician at an NPI level, such items and services furnished by the MIPS eligible clinician would be included for purposes of applying the MIPS payment adjustment or making eligibility determinations.

b. Group Practice (Group)

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. Also, we 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. In section II.C.4.d. of this proposed rule, we discuss how small practice status would apply to virtual groups. Also, in the final rule, 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 as proposed in this proposed rule, calculating the small practice bonus for the final score as proposed in this proposed rule, 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 propose that CMS would determine the size of small practices as described in this section of the proposed rule. As noted in the CY 2017 Quality Payment Start Printed Page 30020Program 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 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 propose that CMS would determine the size of small practices by utilizing claims data. 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 by CMS 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 CMS would conduct a second analysis of claims data during the performance period. Such an expanded determination period may better capture the real-time size of small practices, but determinations made during the performance period prevent our system from being able to account for the assessment and scoring of the improvement activities performance category and identification of small practices eligible for technical assistance prior to the performance period. Specifically, our system needs to capture small practice determinations in advance of the performance period in order for the system to reflect the applicable requirements for the improvement activities performance category and when a small practice bonus would be applied. A second option would include an attestation component, in which a small practice that was not identified as a small practice during the proposed 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 solicit public comment on the proposal regarding how CMS would determine small practice size.

d. Rural Area and Health Professional Shortage Area Practices

In the CY 2017 Quality Payment Program final rule (81 FR 77188), we finalized at § 414.1380 that for individual MIPS eligible clinicians and groups that are located in rural areas or geographic HPSAs, to achieve full credit under the improvement activities performance category, one high-weighted or two medium-weighted improvement activities are required. In addition, 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 are proposing to 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 practices 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 proposed rule for our proposal 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. Also, we 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 Start Printed Page 30021years, we propose that an individual MIPS eligible clinician, a group, or a virtual 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 solicit public comment on these proposals.

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 MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician. We assume many non-patient facing MIPS eligible clinicians will not have sufficient measures and activities applicable and available to report under the performance categories under MIPS. We refer readers to section II.C.6.f.(7) of this proposed rule 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 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 propose 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.

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 include 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 propose to continue applying these policies for purposes of the 2020 MIPS payment year and future years.

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.Start Printed Page 30022

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.

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 provider 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 propose 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. This 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 proposing in section II.C.7.b.(3) of this proposed rule to automatically reweight their advancing care information performance category to zero.

We propose to continue applying these policies for purposes of the 2020 MIPS payment year and future years. We solicit public comment on these proposals.

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 under section 1834(g)(2)(B) of the Act when MIPS eligible clinicians who practice in Method II CAHs have assigned their billing rights to the CAH.

We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77049 through 77051) for our discussion of MIPS eligible clinicians who practice in Method II CAHs.

g. MIPS Eligible Clinicians Who Practice in Rural Health Clinics (RHCs) or Federally Qualified Health Centers (FQHCs)

As established in the CY 2017 Quality Payment Program final rule (81 FR 77051 through 77053), services rendered 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 Start Printed Page 30023performance 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 propose that services rendered by an eligible clinician that are payable under the ASC, HHA, Hospice, or HOPD methodology would not be subject to the MIPS payments adjustments. However, these eligible clinicians have the option to voluntarily report on applicable measures and activities for MIPS, in which the data received would not be used to assess their performance for the purpose of the MIPS payment adjustment. We 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, data reported would be used to determine their MIPS payment adjustment. We solicit public comments on this proposal.

i. MIPS Eligible Clinician Identifier

As described in the CY 2017 Quality Payment Program final rule (81 FR 77057), we established that 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 Identifier 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 physician group or under a different billing number or tax identifier. Additionally, we established at § 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 is therefore 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.

c. Low-Volume Threshold

Section 1848(q)(1)(C)(ii)(III) of the Act provides that the definition of a MIPS eligible clinician does not include MIPS eligible clinicians who are below the low-volume threshold selected by the Secretary under section 1848(q)(1)(C)(iv) of the Act for a given year. Section 1848(q)(1)(C)(iv) of the Act requires the Secretary to select a low-volume Start Printed Page 30024threshold to apply for the purposes of this exclusion which may include one or more of the following: (1) The minimum number, as determined by the Secretary, of Part B-enrolled individuals who are treated by the MIPS eligible clinician for a particular performance period; (2) the minimum number, as determined by the Secretary, of items and services furnished to Part B-enrolled individuals by the MIPS eligible clinician for a particular performance period; and (3) the minimum amount, as determined by the Secretary, of allowed charges billed by the MIPS eligible clinician for a particular performance period.

In the CY 2017 Quality Payment Program final rule (81 FR 77069 through 77070), we defined individual 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, MIPS 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 who 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 provided during informal listening sessions since the publication of the CY 2017 Quality Payment Program final rule, we are proposing to modify the low-volume threshold policy established in the CY 2017 Quality Payment Program final rule. 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 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 criterion decreases the percent 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 for 15 to 16 percent of the total MIPS eligible 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 are proposing to increase the low-volume threshold. Specifically, at § 414.1305, we are proposing 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 Start Printed Page 30025would mean that 37 percent of individual MIPS eligible clinicians and groups would be in MIPS based on the low-volume threshold exclusion (and the other exclusions). However, 65 percent of Medicare payments would still be captured under MIPS 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 MIPS 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 MIPS eligible clinicians and groups who face additional participation burden while not excluding a significant portion of the clinician population.

MIPS 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 MIPS 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 MIPS 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 propose 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. This 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.

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 MIPS 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 MIPS eligible clinician for a particular performance period; and (3) the minimum amount, as determined by the Secretary, of allowed charges billed by the MIPS eligible clinician for a particular performance period. We have established a low-volume threshold that accounts for the minimum number of Part-B enrolled individuals who are treated by a MIPS eligible clinician and that accounts for the minimum amount of allowed charges billed by a MIPS eligible clinician. We have not made proposals specific to a minimum number of items and service furnished to Part-B enrolled individuals by a MIPS 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 a MIPS 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 MIPS 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, Start Printed Page 30026we 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 rendered to a patient to a clinician. We solicit public comment on the methods of defining items and services furnished by clinicians described above and alternate methods of defining items and services.

For the individual MIPS 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 MIPS 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 CMS 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 propose 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. We request public comment on this proposal.

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 seek comment on any additional considerations we should address when establishing this opt-in policy. Such as, should we establish parameters for individual clinicians or groups who elect to opt-in to participate in MIPS such as required length of participation? 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 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. We therefore seek comment on how to address any potential impact on our ability to create quality benchmarks that meet our sample size requirements.

We solicit public comments on these proposals.

3. Group Reporting

a. Background

As described 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 a 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)).
  • 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)).

As noted in the CY 2017 Quality Payment Program final rule, we would not make an eligibility determination regarding group size, but indicated that groups would attest to their group size for purpose of using the CMS Web Interface or a group identifying as a small practice (81 FR 77057). In section II.C.1.d. of this proposed rule, we are proposing to modify the way in which size would be determined for small practices by establishing a process under which CMS would utilize claims data to make small practice size determinations. Also, in section II.C.4.e. of this proposed rule, we are proposing 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, a 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 clinicians (NPIs) who may be excluded from MIPS participation and do not meet the definition of a MIPS eligible clinician.

b. Registration

As described 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 separate 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.Start Printed Page 30027

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. 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. Many stakeholders requested that CMS provide an option that would permit a portion of a group to participate in MIPS outside the group by reporting as a separate subgroup or forming a virtual group. Stakeholders indicated that the option would measure performance more effectively, enable groups to identify areas for improvement at a granular level that would further improve quality of care and health outcomes, and increase coordination of care.

We recognize that groups, including multi-specialty groups, have requested over the years that we make an option available to them 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. We solicit public comment on the ways in which participation in MIPS at the subgroup level could be established.

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. We refer readers to sections II.C.1., II.C.3., and II.C.5. of this proposed rule for a discussion of the previously established requirements for individual- and group-level participation and our proposed policies for performance periods occurring in 2018 and future years. In this rule, we are proposing 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 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. Section 1848(q)(5)(I)(ii) of the Act requires, in accordance with section 1848(q)(5)(I)(iii) of the Act, the establishment and implementation of a process that allows an individual MIPS eligible clinician or a group consisting of not more than 10 MIPS eligible clinicians to elect, for a given performance period, to be a virtual group with at least one other such individual MIPS eligible clinician or group. The virtual group 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 group; (3) a virtual group is a combination of TINs; (4) the requirements must provide 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

As noted above, section 1848(q)(5)(I)(ii) of the Act requires, in accordance with section 1848(q)(5)(I)(iii) of the Act, the establishment and implementation of a process that allows an individual MIPS eligible clinician or group consisting of not more than 10 MIPS eligible clinicians to elect, for a given 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)(V) of the Act provides that a virtual group is a combination of TINs, we interpret 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 propose 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.

Also, we recognize 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 and who are excluded from MIPS under § 414.1310(b) or (c) based on one of four exclusions (new Medicare-enrolled eligible clinician; QP; Partial QP who chooses not to report on measures and activities under MIPS; and eligible clinicians that do not exceed the low-volume threshold). Thus, we interpret 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 that a group with 10 or fewer eligible clinicians (as defined at § 414.1305) would be eligible to form or join a virtual group. For purposes of the MIPS payment adjustment, the 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 MIPS under § 414.1310(b) or (c). We note that such groups, as defined at § 414.1305, would need to include at least one MIPS eligible clinician in order to be eligible to join or form a virtual group. We refer readers to section II.C.4.g. of this proposed rule for discussion regarding the assessment and scoring of groups participating in MIPS as a virtual group.

We propose to define a virtual group at § 414.1305 as a combination of two or more TINs composed of a solo practitioner (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 (as defined at § 414.1305) with 10 or fewer eligible clinicians under the TIN that elects to form a virtual group with at least one Start Printed Page 30028other such solo practitioner or group for a performance period for a year.

Lastly, we note that qualifications as a virtual group for purposes of MIPS do 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.

We note that while entire TINs participate in a virtual group, including each NPI under a TIN, and are assessed and scored collectively as a virtual group, only NPIs that meet the definition of a MIPS eligible clinician would be subject to a MIPS payment adjustment. However, we note that, as discussed in section II.C.4.h. of this proposed rule, any MIPS eligible clinician who is part of a TIN participating in a virtual group and participating in a MIPS APM or Advanced APM under the MIPS APM scoring standard would not receive a MIPS payment adjustment based on the virtual group's final score, but would receive a payment adjustment based on the MIPS APM scoring standard.

Additionally, we recognize 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. 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 (81 FR 77058). Thus, we consider a group to mean an entire single TIN that elects to participate in MIPS at the group or virtual group level, including groups that have a portion of its NPIs participating in a MIPS APM or an Advanced APM. We note that such groups would participate in MIPS similar to other groups.

To clarify, for all groups, including groups containing participants in a MIPS APM or an Advanced APM, the group's performance assessment consists of the entire TIN regardless of whether the group participates in MIPS as part of a virtual group. Generally, for groups other than groups 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, or may be exempt from MIPS if they achieve QP or Partial QP status.

We propose to apply a similar policy to groups, including groups containing participants in a MIPS APM or an Advanced APM, that are participating in MIPS as part of a virtual group. Specifically, for groups other than groups containing participants in a MIPS APM or an Advanced APM, each MIPS eligible clinician (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 group's combined performance assessment (combination of TINs). As discussed in section II.C.4.h. of this proposed rule, we are proposing to use waiver authority to ensure that any participants in the group who are participating in a MIPS APM receive their payment adjustment based on their score under the APM scoring standard (TIN/NPI). Such participants may be exempt from MIPS if they achieve QP or Partial QP status.

We refer readers to section II.C.4.e. of this proposed rule for a discussion of the proposed virtual group election process and section II.C.4.g. of this proposed rule for discussion of our proposals regarding the assessment and scoring of virtual groups.

We recognize that virtual groups would each have unique characteristics and varying patient populations. As noted in section II.C.4.a. of this proposed rule, the statute provides the Secretary with discretion to establish appropriate classifications regarding the composition of virtual groups such as by geographic area or specialty. 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 are not proposing to establish any such classifications regarding virtual group composition. We further note that the statute does not limit the number of TINs that may form a virtual group, and we are not proposing to establish such a limit at this time. We did consider however proposing to establish such a limit, such as 50 or 100 participants. In particular, we are 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, a better approach is to not place such a limit on virtual group size. We will, however, 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 solicit public comment on these proposals, as well as our approach of not establishing appropriate classifications (such as classification by geographic area or specialty) regarding virtual group composition or a limit on the number of TINs that may form a virtual group at this time.

In the CY 2017 Quality Payment Program final rule (81 FR 77073 through 77077), we expressed our commitment to pursue the active engagement of stakeholders throughout the process of establishing and implementing virtual groups. 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. Many stakeholders requested that CMS provide an option that would permit a portion of a group to participate in MIPS outside the group by reporting separately or forming a virtual group. We refer readers to section II.C.b.3. of this proposed rule for discussion regarding a potential option for addressing such issue.

c. MIPS Virtual Group Identifier for Performance

To ensure that we have accurately captured all of the MIPS eligible clinicians participating in a virtual group, we propose that each MIPS eligible clinician who is part of a virtual group would be identified by a unique virtual group participant identifier. The unique virtual group participant Start Printed Page 30029identifier 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 solicit public comment on this proposal.

d. Application of MIPS Group Policies to Virtual Groups

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. We propose to apply our previously finalized and proposed group policies to virtual groups, unless otherwise specified. We recognize 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 have a portion of its NPIs participating in a MIPS APM or an Advanced APM (see section II.C.4.b. of this proposed rule). More generally, such policies may include 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.

With regard to the applicability of the non-patient facing 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. We are proposing 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 refer readers to section II.C.4.f. of this rule for the proposed modification. We note that other policies previously established and proposed in this proposed rule for non-patient facing groups would apply to virtual groups. For example, as discussed in section II.C.1.e. of this proposed rule, virtual groups determined to be non-patient facing would have their advancing care information performance category automatically reweighted to zero.

In regard to the application of small practice status to virtual groups, we are proposing that a virtual group would be identified as having a small practice status if the virtual group does not have 16 or more members of a virtual group (NPIs). We refer readers to section II.C.4.d. of this proposed rule for discussion regarding how small practice status would apply to virtual groups for scoring under MIPS. 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 section II.C.1.c. of this proposed rule, we are proposing 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.

In section II.C.1.e. of this rule, we propose to determine rural area and HPSA practice designations for groups participating in MIPS at the group level. We note that in section II.C.7.b we describe our scoring proposals for practices that are in a rural area or HPSA practice. For performance periods occurring in 2018 and future years, we are proposing that a group with 75 percent or more of the TIN's practice sites designated as rural areas or HPSA practices would be designated as a rural area or HPSA at the group level. We are proposing that a virtual group with 75 percent or more of the virtual group's TINs designated as rural areas or HPSA practices would be designated as a rural area or HPSA practice at the virtual group level. We note that other policies previously established and proposed in this proposed rule for rural area and HPSA groups would apply to virtual groups.

We recognize that the measures and activities available to groups would also be available to virtual groups. Virtual groups would be required to meet the reporting requirements for each measure and activity, and the virtual group would be responsible for ensuring that their measures and activities are aggregated across the virtual group (for example, across their TINs). We note that other previously established group-related policies and proposed policies in this proposed rule pertaining to the four performance categories would apply to virtual groups.

Therefore, we propose to apply MIPS group policies to virtual groups except as otherwise specified. We solicit public comment on this proposal. We are also interested on receiving feedback on how such group-related policies previously established and proposed in this proposed rule either would or would not apply to virtual groups. In addition, we request public comment on any other policies that may need to be clarified or modified with respect to virtual groups, such as 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, the application of the group reporting requirements for the individual performance categories to virtual groups, and the applicability and availability of certain measures and activities to any virtual group participant and to the entire virtual group.

e. Election Process

As noted above, 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. We propose to codify at § 414.1315(a) that a solo practitioner or a group of 10 or fewer eligible clinicians must make their election prior to the start of the applicable performance period and cannot change their election during the performance period. Virtual group participants may elect to be in no more than one virtual group for a performance period and, in the case of a group, the election applies to all MIPS eligible Start Printed Page 30030clinicians in the group. For the 2018 performance year and future years, we are proposing to establish an election period.

We propose to codify 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 1 of the calendar year preceding the applicable performance period. For example, a solo practitioner or group would need to make their election by December 1, 2017 to participate in MIPS as a virtual group during the 2018 performance period. Prior to the election deadline, a virtual group representative would have the opportunity to make an election, on behalf of the members of a virtual group, regarding the formation of a virtual group for an applicable performance period. We intend to publish the beginning date of the virtual group election period applicable to the 2018 performance period and future years in subregulatory guidance.

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 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 propose 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.

We propose to codify 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. Stage 1 pertains to virtual group eligibility determinations. 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 or the Quality Payment Program Service Center 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(a)(1)(i)). We note that activity involved in stage 1 is not required, but a resource available to solo practitioners and groups with 10 or fewer eligible clinicians; otherwise, solo practitioners or groups with 10 or fewer eligible clinicians that do not engage in any activity during stage 1, they would begin the election process at stage 2. For solo practitioners and groups who engage in stage 1 and were determined eligible for virtual group participation, they would proceed to 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, engaging directly in stage 2 as an initial step, solo practitioners and groups may have conducted all such efforts to only have their election registration be rejected with no recourse or remaining time to amend and resubmit.

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 be considered a MIPS eligible clinician (defined at § 414.1305) who bills under a TIN with no other NPIs billing under such TIN, and not excluded from MIPS under § 414.1310(b) and (c). In order for a group to be eligible to form or join a virtual group, a group would need to have a TIN size that does not exceed 10 eligible clinicians and not excluded from MIPS based on the low-volume threshold exclusion at the group level. For purposes of determining TIN size for virtual group participation eligibility, we coin the term “virtual group eligibility determination period” and define it to mean an analysis of claims data during an assessment period of up to five months that would begin on July 1 and end as late as November 30 of a calendar year prior to the performance year and includes a 30-day claims run out.

To capture a real-time representation of TIN size, we propose to analyze up to five months of claims data on a rolling basis, in which virtual group eligibility determinations for each TIN would be updated and made available monthly. We note that an eligibility determination regarding TIN size is based on a relative point in time within the five-month virtual group eligibility determination period, and not an eligibility determination made at the end of such five-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 or the Quality Payment Program Service Center; 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 or the Quality Payment Program Service Center 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, such TIN's size status would be identified at such time and would be retained for the duration of the election period and the 2018 performance period. If another group contacted their designated TA representative or the Quality Payment Program Service Center 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, such TIN's size status would be identified at such time and would be retained for the duration of the election period and the 2018 performance period.

We believe such a virtual group determination period process provides a relative representation of real-time group size for purposes of virtual group eligibility and allows groups to know their real-time size 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 year beginning in 2018, groups would be able to contact their designated TA representative or the Quality Payment Program Service Center and inquire about virtual group participation eligibility. We note that TIN size determinations are based on the number of NPIs associated with a TIN, which would include clinicians (NPIs) excluded from MIPS participation and who do not meet the definition of a MIPS eligible clinician.

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 Start Printed Page 30031for the duration of the election period and applicable performance period.

Stage 2 pertains to virtual group formation. For stage two, we propose the following:

  • 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)). We anticipate this election will occur via email to the Quality Payment Program Service Center using the following email address: 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 confirm through acknowledgment that a written formal agreement has been established between each member of the virtual group prior to election and each member of the virtual group is aware of participating in MIPS as a virtual group for an applicable performance period. Each member of the virtual group must retain a copy of the virtual group's written agreement. We note 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 rule.
  • 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 one time prior to the start of an applicable submission period (§ 414.1315(c)(2)(iv)). We anticipate that 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 proposed rule) that would accompany the virtual group's submission of performance data during the submission period.

In regard to virtual group determinations pertaining to the low-volume threshold, we recognize that such determinations are made at the individual and group level, but not at the virtual group level. The low-volume threshold determinations are applicable to the way in which individual eligible clinicians and groups participate in MIPS as individual MIPS eligible clinicians (solo practitioners) or groups. For example, if an individual MIPS eligible clinician is part of a practice that is participating in MIPS at the individual level (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 at the group level (reporting at the group level), then the low-volume threshold determination at the group level would be applicable to such MIPS eligible clinician regardless of the low-volume threshold determination made at the individual level because such individual MIPS eligible clinician is part of a group reporting at the group level and the low-volume threshold determinations for groups applies to the group as a whole. Similarly, if a solo practitioner or a group with 10 or fewer eligible clinicians seeks to participate in MIPS at the virtual group level (reporting at the virtual group level), then the low-volume threshold determination at the individual or group level would be applicable to such solo practitioner or group with 10 or fewer eligible clinicians. Thus, solo practitioners (individual MIPS eligible clinicians) or groups with 10 or fewer eligible clinicians that are determined not to exceed the low-volume threshold at the individual or group level would not be eligible to participate in MIPS as an individual, group, or virtual group.

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 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 recognize that for the first year of virtual group formation and implementation prior to the start of the 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 2018 performance period, we are providing virtual groups with an opportunity to make an election prior to the publication of our final rule. We intend for the virtual group election process to be available as early as mid-September of 2017; we will publicize the specific opening date via subregulatory guidance. Virtual groups would have from mid-September to December 1, 2017 to make an election for the 2018 performance year. In regard to our proposed policies pertaining to virtual group implementation (for example, definition of a virtual group and election process requirements), we intend to closely align with the statutory requirements in order to establish clear expectations for solo practitioners and Start Printed Page 30032small groups, and have an opportunity to begin the preparation of forming virtual groups in advance of the publication of our final rule. 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, groups participating in a virtual group would have the size of their TIN determined for eligibility purposes. The virtual group size would be determined one time for each performance period. We recognize that the size of a group may fluctuate during a performance period with eligible clinicians and/or MIPS eligible clinicians joining or leaving a group. For groups within a virtual group that are determined to have a group size of 10 eligible clinicians or less based on the one time determination per applicable performance year, any new eligible clinicians or MIPS eligible clinicians that join the group during the performance period would participate in MIPS as part of the virtual group. In such cases, we recognize that a group may exceed 10 eligible clinicians associated with its TIN during an applicable performance period, but at the time of election, such group would have been determined eligible to form or join a virtual group given that the TIN did not have more than 10 eligible clinicians associated with its TIN. 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 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). Virtual groups must re-register before each performance period.

The statute provides that a solo practitioner (TIN/NPI) and a group with 10 or fewer eligible clinicians may elect to be in no more than one virtual group for a performance period. We note that such a solo practitioner or a group that is part of a virtual group may not elect to be in more than one virtual group for a performance period. Also, the statute determines that a virtual group election by the group for an applicable performance period applies to all MIPS eligible clinicians in the group. 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 or group's performance data would continue to be attributed to the virtual group. The remaining members of a 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 (e.g., a group practice closes) to mean a TIN that no longer exists or operates under the auspices of such TIN during a performance year.

As outlined in section 1848(q)(5)(I)(iii) of the Act and previously noted, a virtual group is a combination of TINs, which would include at least two separate TINs associated with a solo practitioner (TIN/NPI), or a group with 10 or fewer eligible clinicians and another such solo practitioner, or group. However, given that a virtual group must be a combination of TINs, we recognize that the composition of a virtual group could include, for example, one solo practitioner (NPI) who is practicing under multiple TINs, 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. For the number of TINs able to form a virtual group, we note that there is not a limit to the number of TINs able to comprise a virtual group.

f. Virtual Group Agreements

The statute provides for formal written agreements among the MIPS eligible clinicians electing to form a virtual group. We propose that each virtual group member 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. We note 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 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 year, 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 propose, 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 NPIs, 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, Health Insurance Portability and Accountability Act, 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)).Start Printed Page 30033
  • 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 all data necessary in order for the virtual group to aggregate its data across the virtual group at § 414.1315(c)(3)(ix)).

As part of the virtual group election ICR, we filed a 60-day notice on June 14, 2017 (82 FR 27257), which includes an agreement template that could be used by virtual groups and will be made available via subregulatory guidance. The agreement template is not required, but serves as a model agreement that could be utilized by virtual groups. The agreement template includes all necessary elements required for such an agreement.

We solicit public comment on these proposals.

Through the formal written agreements, we want to ensure that all members of a virtual group are aware of their participation in a virtual group. As noted above, formal written agreements must include a provision that requires each TIN within a virtual group to notify all NPIs associated with the TIN regarding their participation in the MIPS as a virtual group in order to ensure that each member of a virtual group is aware of their participation in the MIPS as a virtual group. We want to implement an approach that considers a balance between the need to ensure that all members of a virtual group are aware of their participation in a virtual group and the minimization of administration burden. We solicit public comment on approaches for virtual groups to ensure that all members of a virtual group are aware of their participation in the virtual group.

g. Reporting Requirements

As we noted in this proposed rule, 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 propose the following requirements:

  • 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)).

We solicit public comment on these proposals.

h. Assessment and Scoring for the MIPS Performance Categories

As noted above, section 1848(q)(5)(I)(i) of the Act provides that eligible clinicians electing to be a virtual group will: (1) Have their performance assessed for the quality and cost performance categories in a manner that applies the combined performance of all eligible clinicians in the virtual group to each MIPS eligible clinician (except for those participating in a MIPS APM or an Advanced APM under the MIPS APM scoring standard) in the virtual group for a performance period of a year; and (2) be scored based on the assessment of the combined performance described above regarding the quality and cost performance categories for a performance period. We believe it is critical for virtual groups to be assessed and scored at the virtual group level for all performance categories; it eliminates the burden of virtual group members 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. We propose at § 414.1315 that virtual groups would be assessed and scored across all four MIPS performance categories at the virtual group level for a performance period of a year.

In the CY 2017 Quality Payment Program final rule (81 FR 77319 through 77329), we established the MIPS final score methodology, which will apply to virtual groups. We refer readers to sections II.C.7.b. and II.C.8. of this proposed rule for scoring policies that would apply to virtual groups.

As previously noted, we propose 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 year, we recognize 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, must 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.

For participants in MIPS APMs, we propose to 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 must be used to generate the composite 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 composite score of their virtual group.

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 section II.C.6.g. of this proposed rule, we reiterate those concerns and propose additional policies for the APM scoring standard. We believe it is important to Start Printed Page 30034consistently 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.

We note 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.(2) of this proposed rule for further discussion regarding the waiver and the CY 2017 Quality Payment Program final rule (81 FR 77013) for discussion regarding the timeframe used for determining QP status.

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 MIPS payment year 2020, the performance period for the quality and cost performance categories is CY 2018 (January 1, 2018 through December 31, 2018). For the improvement activities and advancing care information performance categories, we finalized at § 414.1320(b)(2) that for purposes of the MIPS payment year 2020, the performance period for the improvement activities and advancing care information performance categories is a minimum of a continuous 90-day period within CY 2018, up to and including the full CY 2018 (January 1, 2018, through December 31, 2018). We are not proposing any changes to these policies.

We also finalized at § 414.1325(f)(2) to use claims with dates of service during the performance period that must be processed no later than 60 days following the close of the performance period for purposes of assessing performance and computing the MIPS payment adjustment. Lastly, we finalized that individual MIPS eligible clinicians or groups who report less than 12 months of data (due to family leave, etc.) would be required to report all performance data available from the applicable performance period (for example, CY 2018 or a minimum of a continuous 90-day period within CY 2018).

We are proposing at § 414.1320(c) and (c)(1) that for purposes of the MIPS payment year 2021 and future years, for the quality and cost performance categories, the performance period under MIPS 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 MIPS payment year 2021, the performance period would be CY 2019 (January 1, 2019 through December 31, 2019), and for the MIPS payment year 2022 the performance period would be CY 2020 (January 1, 2020 through December 31, 2020).

We are proposing at § 414.1320(d) and (d)(1) that for purposes of the MIPS payment year 2021, the performance period for the improvement activities and advancing care information performance categories would be a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable payment year, up to and including the full CY 2019 (January 1, 2019 through December 31, 2019).

We request comments on our proposals for the performance period for MIPS payment year 2021 and future years.

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. For individual eligible clinicians and groups that are not MIPS eligible clinicians, such as physical therapists, but elect to report to MIPS, we will calculate administrative claims-based cost measures and quality measures, if data are available. 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
Start Printed Page 30035
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. 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. In response to the CY 2017 Quality Payment Program final rule (81 FR 77089), we received comments supportive of the use of multiple submission mechanisms for a single performance category due to the flexibility it would provide clinicians. Another commenter supported such an approach because they believed that the scoring of only one submission mechanism per performance category may influence which quality measures a MIPS eligible clinician chooses to report given that the commenter believed only a limited number of measures relevant to one's practice might be available through a particular submission mechanism. The commenter also believed that such flexibility would encourage continued participation in MIPS.

We are proposing 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, via multiple data submission mechanisms for a single performance category (specifically, the quality, improvement activities, or advancing care information performance category). 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 be required to 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 to receive the maximum number of points under a performance category. We considered an approach that would require MIPS eligible clinicians to first submit data on as many required measures and activities as possible via one submission mechanism before submitting data via an additional submission mechanism, but we believe that such an approach would limit flexibility.

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. of this proposed rule, which further outlines how we propose 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 Start Printed Page 30036performance categories. For example, an individual MIPS eligible clinician or group submitting data on four applicable and available quality measures via EHR may not be able to receive the maximum number of points available under the quality performance category. However, with this proposed modification, the MIPS eligible clinician could meet the requirement to report six quality measures by submitting data on two additional quality measure via another submission mechanism, such as claims or qualified registry. This would enable the MIPS eligible clinician to receive the maximum number of points available under the quality performance category. We believe that by providing this flexibility, we would be allowing MIPS eligible clinicians the flexibility 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 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 would like to clarify that the requirements for the performance categories remain the same, regardless of the number of submission mechanisms used. It is also important to note for the improvement activities and advancing care information performance categories, that using multiple data submission mechanisms (for example, attestation and the qualified registry) may limit our ability to provide real-time feedback. While we strive to provide flexibility to individual MIPS eligible clinicians and groups, we would like to note that our goal within the MIPS program is to minimize complexity and administrative burden to individual MIPS eligible clinicians and groups. We request comments on this proposal.

As discussed in section II.C.4. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups. With respect to data submission mechanisms, we are proposing 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. 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 proposed rule, 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 are not proposing any changes to how APM entities in MIPS APMs and their participating MIPS eligible clinicians submit data to MIPS.

(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 are not proposing any changes to the submission deadlines in this 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 Start Printed Page 30037flexibility 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. We continue to believe the NQS domains are extremely important, and we encourage MIPS eligible clinicians to continue to strive to provide care that focuses on: Effective clinical care, communication and care coordination, efficiency and cost reduction, person and caregiver-centered experience and outcomes, community and population health, and patient safety. While we do not require that MIPS eligible clinicians select measures across multiple domains, we encourage them to do so. In addition, we believe the MIPS program overall, with the focus on the quality, cost, improvement activities, and advancing care information performance categories, will naturally cover many elements in the NQS.

(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 the MIPS final score will be based on the quality performance category. For the third and future years, 30 percent of the MIPS final score will be based on the quality performance category.

As discussed in section II.C.6.d. of this proposed rule, we are proposing to weight the cost performance category at zero percent for the second MIPS payment year (2020). 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. Therefore, if our proposal to reweight the cost performance category for MIPS payment year 2020 is finalized, we would need to inversely reweight the quality performance category for the same year. Accordingly, we are proposing 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. For example, if our proposal to reweight the cost performance category to zero percent for MIPS payment year 2020 is finalized, then we would modify § 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 refer readers to section II.C.6.d. for more information on the cost performance category.

As also discussed in section II.C.6.d. of this proposed rule, we note that by reweighting the cost performance category to zero percent in performance period 2018, there will be a sharp increase in the cost performance category to a 30 percent weight in performance period 2019. In order to assist MIPS eligible clinicians and groups in obtaining additional comfort with measurement based on the cost performance category, we considered maintaining our previously-finalized cost performance category weight of 10 percent for the 2018 performance period. However, in our discussions with some MIPS eligible clinicians and clinician societies, eligible clinicians expressed their desire to down-weight the cost performance category to zero percent for an additional year with full knowledge that the cost performance category weight is set at 30 percent under the statute for the 2021 MIPS payment year. The clinicians we spoke with preferred our proposed approach and noted that they are actively preparing for full cost performance category implementation and would be prepared for the 30 percent statutory weight for the cost performance category for the 2021 MIPS payment year.

We intend to provide an initial opportunity for clinicians to review their performance based on the new episode-based measures at some point in the fall of 2017, 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 proposed rule. 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 proposed 2019 MIPS performance period. We are unable to offer a list of new episode-based measures on which we will provide feedback because that will be determined in our ongoing development work described above. We are concerned that continuing to Start Printed Page 30038provide 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. As described in section II.C.9.a. of this proposed rule, we intend to provide feedback on these new measures as they become available in a new format around summer 2018, in addition to the fall 2017 feedback discussed previously. We note 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 that a clinical 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, along with the previously-finalized total per capita cost and MSPB measures, will support clinicians in their readiness for the proposed 2019 MIPS performance period.

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.

(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)(e)., 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 proposed rule or one of the specialty measure sets listed in Table B of the Appendix in this proposed rule. 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 proposed rule with regard to the CMS Web Interface and the CAHPS for MIPS survey, we are not proposing any changes to the submission criteria or definitions established for measures in this 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 received conflicting feedback on adding a future requirement for MIPS eligible clinicians to report at least one cross-cutting measure in the Quality Payment Program Year 2 and future years.Start Printed Page 30039

Many commenters agreed that cross-cutting measures are applicable across multiple clinical settings and that MIPS eligible clinicians within a variety of specialties should report at least one cross-cutting measure. Some stated that cross-cutting measures promote shared accountability and improve the health of populations. Others recommended we continue to work with stakeholders and specialists, including solo and small practices, to develop cross-cutting measures for all settings, whether they be patient-facing or non-patient facing practices that are patient-centric (that is, following the patient and not the site of care) and recommended the term “patient-centered measures” rather than “cross-cutting measures.” In addition, some commenters stated we should consider measures that are multidisciplinary, foster cross-collaboration within virtual groups, improve patient outcomes, target high-cost areas, target areas with gaps in care, and include individual patient preferences in shared decision-making. A few commenters provided specific measures that they recommended utilizing as cross-cutting measures, such as: Screening for Hepatitis C; Controlling High Blood Pressure; Tobacco Use Cessation Counseling and Treatment; Advance Care Planning; or Medication Reconciliation. One commenter recommended we utilize shared accountability measures around surgical goals of care, shared decision making relying on some form of risk estimation such as a risk calculator, medication reconciliation, and a shared plan of care across clinicians. Another commenter suggested that instead of having a cross-cutting measure requirement, we could use health IT as a cross-cutting requirement. Specifically, the commenter noted we could require that at least one measure using end-to-end electronic reporting, or that at least one measure be tied to an improvement activity the clinician is performing. Other commenters suggested that we provide bonus points to practices that elect to submit data on cross-cutting measures and hold harmless from any future cross-cutting measure requirements MIPS eligible clinicians who have less than 15 instances in the measure denominator during the performance period, allow MIPS eligible clinicians to use high-priority measures in the place of a cross-cutting measure if necessary, and apply the guiding principles listed in NQF's “Attribution: Principles and Approaches” final report which may be found at http://www.qualityforum.org/​ProjectDescription.aspx?​projectID=​80808.

Other commenters appreciated our decision not to finalize the requirement to report a cross-cutting measure in the transition year and requested that we not require cross-cutting measures in the future, as they believed it is administratively burdensome for clinicians and QCDRs and removes focus and resources from quality measures that are more relevant to MIPS eligible clinicians' scope of practice and important to their patients' treatment and outcomes. They stated that PQRS demonstrated the challenge of identifying cross-cutting measures that are truly meaningful across different specialties and that truly have an impact on improving the health of populations. Some stated we should focus on high-priority measures over cross-cutting measures. A few commenters did not agree that cross-cutting measures were relevant and stated they should not be a requirement in MIPS until all MIPS eligible clinicians can successfully meet the current requirements. Others did not agree that QCDRs should be required to submit cross-cutting measures because they believed that Congress did not intend for QCDRs to submit clinical process measures, that implementation may be complicated by practices that upgrade their health IT, and vendors have indicated it would take 12 to 18 months to implement system changes to support capture of cross-cutting measures. They also questioned the value of investing additional time and resources in this effort, especially if these cross-cutting measures are ultimately found to be topped out or removed. Others believed we should delay implementation until the Quality Payment Program Year 3 in order to allow MIPS eligible clinicians to focus on implementing new CEHRT requirements and modifying their processes to address lessons learned from reporting in the first 2 years.

Except as discussed in section II.C.6.b.(3)(a)(iii). of this proposed rule with regard to the CAHPS for MIPS survey, we are not proposing any changes to the submission criteria for quality measures in this proposed rule. We thank the commenters for their feedback and will take the comments into consideration in future rulemaking. We welcome additional feedback on meaningful ways to incorporate cross-cutting measurement into MIPS and the Quality Payment Program generally.

(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 who want to report via the CMS Web Interface. For the applicable 12-month performance period, the group would be required to report on all measures included in the CMS Web Interface completely, accurately, and timely by populating data fields for the first 248 consecutively ranked and assigned Medicare beneficiaries in the order in which they appear in the group's sample for each module or measure. If the sample of eligible assigned beneficiaries is less than 248, then the group would report on 100 percent of assigned beneficiaries. A group would be required to report on at least one measure for which there is Medicare patient data. Groups reporting via the CMS Web Interface are required to report on all of the measures in the set. Any measures not reported would be considered zero performance for that measure in our scoring algorithm. In addition, we are proposing to clarify that these criteria apply to groups of 25 or more eligible clinicians. Specifically, we propose to revise § 414.1335(a)(2)(i) to provide criteria applicable to groups of 25 or more eligible clinicians, report on all measures included in the CMS Web Interface. The group must report on the first 248 consecutively ranked beneficiaries in the sample for each measure or module.

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 population quality measure discussed in the CY 2017 Quality Payment Program proposed rule (81 FR 28188) 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 note that groups reporting via the CMS Web Interface may also report the CAHPS for MIPS survey and receive bonus points for submitting that Start Printed Page 30040measure. We are not proposing any changes to the submission criteria for quality measures for groups reporting via the CMS Web Interface in this proposed rule.

(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 are not proposing any changes to the performance criteria for quality measures for groups electing to report the CAHPS for MIPS survey in this 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 CAHPS for MIPS survey data earlier than the current survey administration period deadline allows. Therefore, we are proposing 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. In addition, we propose 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 are proposing 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. We are proposing 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 ACO 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 are proposing to remove this SSM in order to maintain consistency with the Medicare Shared Savings Program which, utilizes the CAHPS for Accountable Care Organizations (ACOs) Survey. The SSM entitled “Between Visit Communication” has never been a scored measure with the Medicare Shared Savings Program CAHPS for ACOs Survey.

In addition to public comments we receive, we will also take into consideration analysis we will be conducting before finalizing this proposal. Specifically, we will review the findings of the CAHPS for ACO survey pilot, which was administered from November 2016 through February 2017. The CAHPS for ACO survey pilot utilized a survey instrument which did not contain the two SSMs we are proposing 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—Proposed Summary Survey Measures (SSMs) Included in the CAHPS for MIPS Survey

Summary survey measures (SSMs)
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 are seeking comment on expanding the patient experience data available for the CAHPS for MIPS survey. 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 ask for 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 Start Printed Page 30041decision for healthcare, but it would also greatly aid individual MIPS eligible clinicians and groups as they assess how their patients experience care. We are seeking 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. In the CY 2017 Quality Payment Program proposed rule (81 FR 28189), we requested comments on ways to modify the methodology to assign and sample patients for these mechanisms using data from other payers. We received mixed feedback on the use of all-payer data overall. The full discussion of the comments and the responses can be found in the CY 2017 Quality Payment Program final rule (81 FR 77123 through 77125). We are requesting additional 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. In particular, we are seeking 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 would like to seek 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 are also seeking comment on EHR vendors' ability to provide information on the patients who receive care from their client groups.

(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 below 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 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 these thresholds for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims would increase for performance periods occurring in 2019 and onward.

We are proposing to modify the previously established data completeness criteria for MIPS payment year 2020. Specifically, we would like 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 are concerned 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 want 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 propose, below, a 60 percent data completeness threshold for MIPS payment year 2021. We strongly encourage 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 are providing 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 propose 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 propose 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 propose 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 propose 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 Start Printed Page 30042B patients seen during the performance period to which the measure applies for MIPS payment year 2021. We would like to note 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 are seeking 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 scope of practice and provides more access to data about specialties and subspecialties not currently captured in PQRS. In addition, those clinicians who utilize a QCDR, qualified registry, or EHR submission must contain a minimum of one quality measure for at least one Medicare patient. We are not proposing any changes to these policies in this proposed rule. 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 are proposing that MIPS eligible clinicians would receive 1 point for measures that fall below the data completeness threshold, with an exception for small practices of 15 or fewer who would still receive 3 points for measures that fail data completeness. We refer readers to section II.C.6.b.(3)(b) of this proposed rule for our proposed policies on instances when MIPS eligible clinicians' measures fall below the data completeness threshold.

(c) Summary of Data Submission Criteria

Table 5 reflects our proposed quality data submission criteria for MIPS payment year 2020 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 rule, we are proposing to revise § 414.1325(d) for purposes of the 2020 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 proposed rule for further discussion of this proposal.

Table 5—Summary of Proposed Quality Data Submission Criteria for MIPS Payment Year 2020 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 in Table A or one of the specialty measure sets listed in Table B of the Appendix in this proposed rule50 percent of individual MIPS eligible clinician's Medicare Part B patients for the performance period.
Jan 1-Dec 31Individual MIPS eligible clinicians, groups or virtual 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, groups, or virtual groups would have to select their measures from either the set of all MIPS measures listed or referenced in Table A or one of the specialty measure sets listed in Table B of the Appendix in this proposed rule50 percent of individual MIPS eligible clinician's, group's, or virtual group's patients across all payers for the performance period.
Jan 1-Dec 31Groups or virtual groupsCMS 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 or virtual group's sample for each module/measure. If the pool of eligible assigned beneficiaries is less than 248, then the group or virtual group would report on 100 percent of assigned beneficiariesSampling requirements for the group's or virtual group's Medicare Part B patients.
Start Printed Page 30043
Jan 1-Dec 31Groups or virtual groupsCAHPS 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 or virtual group's Medicare Part B patients.

As discussed in section II.C.4.d. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups.

(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 are not proposing any changes to this policy in this 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 proposed rule for a full discussion of our proposals 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, 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 quality measure domain for the MIPS total performance score. 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 was scored on the ACR measure even if it did not submit any quality measures, if it submitted in other performance categories. Otherwise, the group was not 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 on one of the three performance categories as discussed in the CY 2017 Quality Payment Program final rule (81 FR 77329). In addition, the ACR measure in the MIPS transition year CY 2017 was based on the performance period (January 1, 2017 through December 31, 2017). However, for MIPS eligible clinicians who did not meet the minimum case requirements, the ACR measure was not applicable. We are not proposing any changes for the global and population-based measures in this proposed rule. As discussed in section II.C.4.d. of this rule, we are proposing to generally apply our previously finalized and proposed 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. MIPS eligible clinicians reporting on the quality performance category are required to use the most recent version of the clinical quality measure (CQM) electronic specifications as indicated in the CY 2017 Quality Payment Program final rule (81 FR 77291). For purposes of the 2018 MIPS performance period, the spring 2017 version of the eCQM annual update to the measure specifications and any applicable addenda are available on the electronic clinical quality improvement (eCQI) Resource Center Web site at https://ecqi.healthit.gov. The CMS Quality Measure Development Plan (MDP) serves as a strategic framework for the future of the clinician quality measure development to support MIPS and APMs. The MDP is available on the CMS Web site and highlights known measurement gaps and recommends Start Printed Page 30044approaches to close those gaps through development, use, and refinement of quality measures that address significant variation in performance gaps. 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” 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 measures for consideration unless they believe that the measure is applicable to clinicians and can be reliably and validly measured at the individual clinician level. The NQF-convened Measure Application Partnership (MAP) provides an additional opportunity for stakeholders to provide input on whether or not they believe the measures are applicable to clinicians as well as feasible, scientifically acceptable, and reliable and valid at the clinician level. Furthermore, we must go through notice and comment rulemaking to establish the annual list of quality measures, which gives stakeholders an additional opportunity to review the measures and provide input on whether or not they believe the measures are applicable to clinicians, as well as feasible, scientifically acceptable, and reliable and valid at the clinician level. Additionally, we are required by statute to submit new measures to an applicable specialty-appropriate, peer-reviewed journal.

As previously noted, we encourage the submission of potential quality measures regardless of whether such measures were previously published in a proposed rule or endorsed by an entity with a contract under section 1890(a) of the Act. However, we propose to request that stakeholders apply the following considerations when submitting quality measures for possible inclusion in MIPS:

  • Measures that are not duplicative of an existing or proposed measure.
  • Measures that are beyond the measure concept phase of development and have started testing, at a minimum, with strong encouragement and preference for measures that complete 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 note 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 note 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 since we do not always develop measures for the quality programs. 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 on the quality performance category, we use quality measures developed by QCDRs. In the circumstances where a QCDR wants to Start Printed Page 30045use 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 proposal to add 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 are found in Table A. The proposed new and modified MIPS specialty sets for the 2018 performance period and future years are listed in Table B, and include existing measures that are proposed with modifications, new measures, and measures finalized in the CY 2017 Quality Payment Program final rule. We note 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. The specialty measure sets in Table B of the Appendix, include existing measures that are proposed with modifications, new measures, and measures that were previously finalized in the CY 2017 Quality Payment Program final rule. 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 recommendations for potential new specialty measure sets for year 2 of MIPS under the Quality Payment Program. These recommendations were based on the MIPS quality measures finalized in the CY 2017 Quality Payment Program final rule, and include recommendations to add or remove the current MIPS quality measures from the specialty measure sets. The current specialty measure sets can be found on the Quality Payment Program Web site at https://qpp.cms.gov/​measures/​quality. All specialty measure sets submitted for consideration were assessed to ensure that they met the needs of the Quality Payment Program.

As a result, we propose to add new quality measures to MIPS (Table A), revise the specialty measure sets in MIPS (Table B), remove specific MIPS quality measures only from specialty sets (Table C.1), and propose to remove specific MIPS quality measures from the MIPS program for the 2018 performance period (Table C.2). The aforementioned measure tables can be found in the Appendix of this proposed rule. In addition, we are proposing 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. 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 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 proposed Table of Cross-Cutting Measures can be found in Table D of the Appendix.

For MIPS quality measures that are undergoing substantive changes, we propose 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.

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) 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.

We also seek comment for this rule, 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 is being proposed in this rule.

(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 proposed rule for additional information regarding the scoring of topped out measures.

We noted in the CY 2017 Quality Payment Program final rule that we anticipate removing topped out measures over time and sought comment on what point in time we should remove topped out measures from MIPS (81 FR 77286). We received the following comments.

Many commenters recommended that we retain topped out quality measures for 2 or more years because commenters believed they serve to motivate continued high-quality care; more clinicians may participate in MIPS compared to prior programs such as PQRS, and thus there may be more performance variation in MIPS showing that the measure is not actually topped out; declines in performance will not be captured if a measure is eliminated; it will help provide stability and encourage reporting in the early years of the MIPS program; removing topped out measures could further limit the number of measures available to specialists; and providing eligible clinicians and the public with information about high performance is as important as informing them about deficits.

A few commenters recommended that we publish information about topped out and potentially topped out measures prior to the performance period to allow clinicians time to adjust their reporting Start Printed Page 30046strategies, with one commenter noting that improvement may be rewarded in addition to achievement. One commenter recommended pushing back the baseline performance period for the purpose of identifying topped out measures to 2018 because in the transition year it is unclear how many eligible clinicians will be reporting at different times and for what time period they will report.

Finally, a few commenters recommended that we consider specialty, case mix, and rural location before determining that a measure is topped out, specifically whether there is still room for improvement among certain specialist groups and to ensure that rural provider improvement is recognized. One commenter recommended that we determine topped out measures based on reporting in the Quality Payment Program rather than PQRS or value modifier reporting because the commenter believed using historical performance disadvantages small groups. A few commenters requested that the process for identifying and determining the removal of topped out measures be transparent, evidence-based, patient-centered, and include feedback from all appropriate stakeholders, including the medical community and measures owner. A few commenters specifically recommended that determining whether to remove a topped out measure be part of a rulemaking process while another commenter suggested that we seek out stakeholder input from the Measure Applications Partnership (MAP) on whether a measure should be removed, awarded lower points, or remain with benchmarks as a flat percentage.

We propose a 3-year timeline for identifying and proposing to remove topped out measures. After a measure has been identified as topped out for three consecutive years, we may propose to remove the measure through comment and 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 provides a path toward removing topped out measures over time, and will apply to the MIPS quality measures. QCDR measures that consistently are identified as topped out according to the same timeline as proposed below, would not be approved for use in year 4 during the QCDR self-nomination review process, and would not go through the comment and rulemaking process described below.

We propose 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 proposed rule. In section II.C.7.a.(2)(c) of this proposed rule, we are also proposing to phase in special scoring for measures identified as topped out in the published benchmarks for two 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), is as follows:

  • Year 1: The 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 proposed rule 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 three MIPS performance periods, then the lifecycle would stop and start again at year 1 the next time the measure benchmark is topped out.

We seek comment on the above 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. For example, should we automatically remove topped out measures after they are identified for the proposed number of years or should we review measures identified for removal and consider certain criteria before removing the measure? If so what criteria should be considered? We would like to note 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.

We also seek 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.

In the CY 2017 Quality Payment Program final rule, we state 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 proposed rule for information on scoring policies with regards to topped out measures from the CMS Web Interface for the Quality Payment Program. We are not proposing to include CMS Web Interface measures Start Printed Page 30047in our proposal on removing topped out measures.

(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).

A few commenters recommended that measures that cannot be scored against a benchmark should be removed from the MIPS score. One commenter recommended that non-outcome measures that are unscorable should be given a weight of zero or re-weighted in the performance category. One commenter supported removing non-outcomes measures for which performance cannot reliably be scored against a benchmark for 3 years in a row. One commenter believed it would also be appropriate to remove outcomes measures under a separate more protracted timeline because the commenter believed the reporting of outcome measures is more difficult and expected to increase at a slower pace, while maintaining outcome measures would encourage the testing and availability of such measures.

Based on the need for CMS to further assess this issue, we are not proposing to remove non-outcome measures in this proposed rule. However, we seek 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. We intend to revisit this issue and make proposals in future rulemaking.

(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 utilize the following as a basis to determine if a measure is considered an outcome measure:

  • Measure Steward and National Quality Forum (NQF) designation—For most measures, we will utilize the designation as determined by the measure steward and the measure's NQF designation to determine if it is an outcome measure or not. If this is not clear, we will consider the following step.
  • Utilization of the CMS Blueprint definitions for outcome measures: https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​MMS/​Downloads/​Blueprint-130.pdf. An outcome of care is a health state of a patient resulting from health care. Outcome measures are supported by evidence that the measure has been used to detect the impact of one or more clinical interventions. Clinical analysts are utilized to evaluate the measure.

We also note that patient-reported outcome measures are considered outcome measures, as they measure the health of the patient directly resulting from the health care provided. Efficiency measures are not considered outcome measures, as they are measuring the cost of care associated with a specific level of care, but we do note that efficiency is considered a high priority measure.

After a MIPS quality measure is established in the program, it is generally only reviewed again if there are significant changes to a measure for the next program year that might warrant a change to the designation of outcome or not. In most cases, these updates are significant enough that they are usually presented as a new measure from the measure owner. New measures to the program will follow the criteria outlined above. QCDR measures however, are reviewed on a yearly basis (during the fall) regardless if there is a significant change or not. We refer readers to section II.C.10.a. for additional information on the QCDR self-nomination and measures review and approval process.

We seek comment on the criteria and process outlined above on how we designate outcome measures. Specifically are there additional criteria we should take into consideration when we determine if a measure meets the criteria of an outcome measure? Should we use different criteria for MIPS measures versus QCDR measures?

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 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 in the final score in order to give clinicians more opportunity to understand the attribution and the scoring methodology and gain more familiarity with the measures through performance feedback (81 FR 77165 through 77166) so that clinicians may be able to act to improve their performance. 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 APM models incorporate cost measurement in other ways. For more on the APM scoring standard, see II.C.6.E. of this proposed rule.

(2) Weighting in the Final Score

We are proposing 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 continue to have concerns Start Printed Page 30048about the level of familiarity and understanding of cost measures among clinicians. We will use this additional year in which the score in the cost performance category does not count towards the final score for outreach to increase understanding of the measures so that clinicians will be more comfortable with their role in reducing costs for their patients. In addition, we will use this additional year to develop more episode-based measures, which are cost measures that are focused on a clinical conditions or procedures. We intend to propose in future rulemaking to adopt episode-based measures currently in development.

Although we believe reducing this weight is appropriate given the level of understanding of the measures and the scoring standards, we note that section 1848(q)(5)(E)(i)(II)(aa) of the Act requires the cost performance category be assigned a weight of 30 percent of the MIPS final score beginning in the 2021 MIPS payment year. We recognize 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. This policy could reduce understanding of the measures when we reach the 2021 MIPS payment year and the cost performance category will be used to determine 30 percent of the final score for MIPS eligible clinicians, when in the two previous years it was weighted at zero. Therefore, we also seek comment on keeping the weight of the cost performance category at 10 percent for the 2020 MIPS payment year.

In our discussions with clinicians and clinician societies, clinicians expressed their desire to down-weight the cost performance category to zero percent for an additional year with full knowledge that the cost performance category weight is set at 30 percent under the statute for the 2021 MIPS payment year. The clinicians we spoke with preferred a low weighting and noted that they are actively preparing for cost performance category implementation and would be prepared for the 30 percent statutory weight for the cost performance category for the 2021 MIPS payment year. We intend to continue to provide education to clinicians to help them prepare for the upcoming 30 percent weight.

We invite public comments on this proposal of a zero percent weighting for the cost performance category and the alternative option of 10 percent weighting for the cost performance category for the 2020 MIPS payment year.

(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. Section 1848(r)(2) of the Act requires the development of care episode and patient condition groups, and classification codes for such groups, and provides for care episode and patient condition groups to account for a target of an estimated one-half of expenditures under Parts A and B (with this target increasing over time as appropriate). Section 1848(r) of the Act requires us to consider several factors when establishing these groups. For care episode groups, we must consider the patient's clinical problems at the time items and services are furnished during an episode of care, such as clinical conditions or diagnoses, whether inpatient hospitalization occurs, the principal procedures or services furnished, and other factors determined appropriate by the Secretary. For patient condition groups, we must consider the patient's clinical history at the time of a medical visit, such as the patient's combination of chronic conditions, current health status, and recent significant history (such as hospitalization and major surgery during a previous period), and other factors determined appropriate.

Section 1848(r)(2) of the Act requires us to post on the CMS Web site a draft list of care episode and patient condition groups and codes for solicitation of input from stakeholders, and subsequently, post on the CMS Web site an operational list of such groups and codes. In December 2016, we published the Episode-Based Cost Measure Development for the Quality Program (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) and requested input on a draft list of care episode and patient condition groups and codes as required by section 1848(r)(2)(E) and (F) of the Act. We additionally requested feedback on our overall approach to cost measure development, including several pages of specific questions on the proposed approach for clinicians and stakeholders to provide feedback on. This feedback will be used to modify our cost measure development and ensure that our approach is continually informed by stakeholder feedback. We are currently reviewing the feedback that was recently received on that posting and will share plans to work with clinicians and others on the further developments of these episodes in the future.

We will be posting the operational list of care episode and patient condition groups in December 2017, as required by section 1848(r)(2)(G) of the Act. Section 1848(r)(2)(H) of the Act also requires that not later than November 1 of each year (beginning with 2018), the Secretary shall, through rulemaking, revise the operational list as the Secretary determines may be appropriate.

(ii) Total Per Capita Cost and MSPB Measures

For the 2018 MIPS performance period and future performance periods, we are proposing 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. We refer readers to the description of these measures in the CY 2017 Quality Payment Program final rule (81 FR 77164 through 77171). We are proposing 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, based on 2014 performance) and to all groups in the annual QRUR since 2014 (based on 2013 performance) and mid-year QRUR since 2015. We are proposing to use the MSPB measure because many MIPS eligible Start Printed Page 30049clinicians 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 (based on 2013 performance) and the mid-year QRUR since 2015, or its hospital-specified version, which has been a part of the Hospital VBP Program since 2015, based on 2013 performance. 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 are not proposing 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 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.

We invite public comments on these proposals.

(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 are not proposing 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.

Thus far, stakeholder feedback has been sought in several ways. First, stakeholder feedback has been sought through various public postings. In October 2015 and April 2016, pursuant to section 1848(r)(2)(B) and (C) of the Act, we gathered input from stakeholders on the episode groups previously developed under section 1848(n)(9)(A) of the Act that has been used to inform the process of constructing the new episode-based cost measures. This feedback emphasized several key aspects of cost measure development such as attribution, risk adjustment, and alignment with quality measurement and patient outcomes. Stakeholders have also emphasized that feedback related to cost measures should be actionable and timely. In addition, a draft list of care episode and patient condition groups, along with trigger codes, 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) as required by section 1848(r)(2)(E) of the Act and comments were accepted as required by section 1848(r)(2)(F) of the Act.

This draft list of care episode and patient condition groups and trigger codes was informed by engagement with clinicians from over 50 clinician specialty societies through a Clinical Committee formed to participate in cost measure development. The Clinical Committee work has provided input from a diverse array of clinicians on identifying conditions and procedures for episode groups. Moving forward, the Clinical Committee will recommend 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 3 times 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, and attributing episode groups to clinicians. 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. Earlier this year, we opened an opportunity to submit the names of clinicians to participate in this process. This process remains open to additional individuals. 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. Recognizing that under section 1848(q)(5)(E)(i)(II)(aa) of the Act, we must assign a weight of 30 percent to the cost performance category for the 2021 MIPS payment year, we will endeavor to have as many episode-based measures available as possible for the proposed 2019 MIPS performance period.

We plan to include episode-based measures in the cost performance category in future years as they are developed and would propose new measures in future rulemaking.

Although we are not proposing to include any episode-based measures in calculating the cost performance category score for the 2020 MIPS payment year, 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 Start Printed Page 30050in determining the cost performance category score in the future. Because these measures will be generated based on claims data like other cost measures, we will not collect any additional data from clinicians. As we develop new episode-based measures, we believe it is likely that they would cover similar clinical topics to those that are in the previously developed episode-based measures because of our intent to address common clinical conditions with episode-based measures. We aim to provide an initial opportunity for clinicians to review their performance based on the new episode-based measures at some point in the fall of 2017, 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 proposed rule. 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 proposed 2019 MIPS performance period. We are unable to offer a list of new episode-based measures on which we will provide feedback because that will be determined in our ongoing development work described above. 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. As described in section II.C.9.a. of this proposed rule, we intend to provide feedback on these new measures as they become available in a new format around summer 2018. We note 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, along with the previously-finalized total per capita cost and MSPB measures, will support clinicians in their readiness for the proposed 2019 MIPS performance period.

As previously finalized in the CY 2017 Quality Payment Program final rule (81 FR 77173), the episode-based measures that we are not proposing for the 2018 MIPS performance period will be used for determining the cost performance category score for the 2019 MIPS payment year, although the cost performance category score will be weighted at zero percent in that year.

We invite public comments on this proposal.

(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 propose 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.

We are not proposing any changes to the attribution methods for the MSPB measure and refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77168 through 77169) for more information.

We invite public comment on our proposals.

(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. Statistically, reliability depends on performance variation for a measure across clinicians (“signal”), the random variation in performance for a measure within a clinician's attributed beneficiaries (“noise”), and the number of beneficiaries attributed to the clinician. High reliability for a measure suggests that comparisons of relative performance among clinicians are likely to be stable over different performance periods and that the performance of one clinician on the measure can be confidently distinguished from another. As an example of the statistical concept of reliability, a test in which the same individual received very different scores depending on how the included questions are framed would not be reliable. Potential reliability values range from 0.00 to 1.00, where 1.00 (highest possible reliability) signifies that all variation in the measure's rates is the result of variation in differences in performance across clinicians, whereas 0.0 (lowest possible reliability) signifies that all variation could be a result of measurement error. The 0.4 reliability threshold that we adopted for the cost performance category measures in MIPS means that the majority of MIPS eligible clinicians and groups who meet the case minimum required for scoring under a measure have measure reliability scores that exceed 0.4. We generally consider reliability levels between 0.4 and 0.7 to indicate “moderate” reliability and levels above 0.7 to indicate “high” reliability.

We addressed comments we received on the CY 2017 Quality Payment Program proposed rule (81 FR 77169 through 77171), that expressed concern that our 0.4 reliability threshold was too low. Many commenters recommended that cost measures be included only when they could meet the standard of “high” reliability (0.7 or above). Many commenters on the CY 2017 Quality Payment Program final rule made similar comments. Commenters emphasized the importance of reliability; however, we have also seen commenters incorrectly refer to measures as being 40 percent reliable. Reliability is not a percentage but is instead a coefficient so a measure with 0.4 reliability does not reflect that it is only correct for 40 percent of those measured. We encourage a review of our analysis of reliability for the total per capita cost measure (80 FR 71282) and MSPB (81 FR 77169 through 77171).

Reliability is an important evaluation tool for an individual measure, but it is only one element of evaluation. Reliability generally increases as we increase the case size but a high reliability may also reflect low variation. A measure in which all clinicians perform at nearly the same rate would be reliable but not valuable in a program Start Printed Page 30051that attempts to recognize and reward differential performance. A measure in which there is very little variation provides little value in a program like MIPS given the devotion of resources to developing and maintaining that measure over other potential measures. Reliability must also be considered in the context of a measurement system like MIPS which incorporates other elements of measurement. We understand and appreciate the concerns that have been expressed about reliability of measures. Medicine, however, always has a certain amount of variability which may affect the reliability score. We want strong reliability, but not at the expense of losing valuable information about clinicians. We are concerned that placing too much of an emphasis on reliability calculations could limit the applicability of cost measures to large group practices who, by nature of their size, have larger patient populations, thus depriving solo clinicians and individual reporters from being rewarded for efforts to better manage patients. Therefore, we are not proposing any adjustments to our reliability policies, but 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 are not proposing 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).

(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 rule.

(d) Incorporation of Cost Measures With ICD-10 Impacts

In section II.C.7.a.(1)(c) of this proposed rule, we discuss 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.

(e) Application of Measures to Non-Patient Facing MIPS Eligible Clinicians

We are not proposing 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.

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 contributed 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 on the role of patient-facing clinicians. Accordingly, for the 2018 MIPS performance period, we are not proposing 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 continue to consider opportunities to develop alternative cost measures for non-patient facing clinicians and solicit comment on this topic to inform our future rulemaking.

(f) Facility-Based Measurement as it Relates to the Cost Performance Category

In section II.C.7.a.(4) of this proposed rule, we discuss 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 that section for full details on our proposals 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 Start Printed Page 30052non-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).

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. We received several comments in support of the concept to include emerging certified health IT capabilities as part of the activities in the Improvement Activities Inventory and several commenters supported our assessment that using CEHRT can aid in improving clinical practices and help healthcare organizations achieve success on numerous improvement activities, as well as the continued integration of improvement activities and advancing clinical information. However, several commenters expressed concern about health IT-associated burdens and costs and recommended that we also continue to offer diverse activities that do not rely on emerging capabilities of certified health IT, as they are not universally available or may only be offered as high cost add-on capabilities. Some commenters also requested that we be less prescriptive in our requirements for the use of health IT.

In response to the comments, we will continue to focus on incentivizing the use of health IT, telehealth, and connection of patients to community-based services. The use of health IT is an important aspect of care delivery processes described in many of the proposed new improvement activities in Table F in the Appendix of this proposed rule, and in Table H: Finalized Improvement Activities Inventory that we finalized in the CY 2017 Quality Payment Program final rule (81 FR 77817 through 77831). In that same final rule, we also finalized a policy to allow MIPS eligible clinicians to achieve a bonus in the advancing care information performance category when they use functions included in CEHRT to complete eligible activities from the Improvement Activities Inventory. Please refer to section II.C.6.f.(2)(d) of this proposed rule 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 are not proposing any changes to these policies for incentivizing the use of health IT in this proposed rule; however, we will continue to consider including emerging certified health IT capabilities as part of activities within the Improvement Activities Inventory in future years.

In addition, as noted previously, we believe a key goal of the Quality Payment Program is to establish a program that allows for close alignment of the four performance categories. Although we are not proposing any specific new policies, we seek comment on how we might provide flexibility for MIPS eligible clinicians to effectively demonstrate improvement through health IT usage while also measuring such improvement. We welcome public comment on these considerations.

(2) Contribution to the Final Score

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. We are proposing to clarify the term “certified” patient-centered medical home finalized at § 414.1380(b)(3)(iv). 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 we are proposing 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 propose 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. For purposes of § 414.1380 (b)(3)(iv), “full credit” means that the MIPS eligible clinician or group has met the highest potential category score of 40 points. 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).

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. Several commenters urged us 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 us to be more transparent in our weighting decisions. Several commenters recommended that we 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 current medium-weighted activities to high and offered many specific suggestions for new high-weighted improvement activities.

In response to the comments, we are proposing new, high-weighted activities in Table F in the Appendix of this proposed rule. As 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. We are not proposing changes to this approach in this proposed rule; however, we will take these suggested additional criteria into consideration for designating high-weighted activities in future rulemaking. For MIPS eligible clinicians participating in MIPS APMs, we finalized a policy to reduce reporting burden through the APM scoring standard for this 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 Start Printed Page 30053final rule for further details on reporting and scoring this category under the APM Scoring Standard (81 FR 77259 through 77260).

(3) Improvement Activities Data Submission Criteria

(a) Submission Mechanisms

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, 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 finalized 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. 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 certify all improvement activities 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 this policy into future years. Therefore, we are proposing at § 414.1360 that for purposes of 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. 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 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. In addition, as discussed in section II.C.4.d. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups.

We would like 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 proposed rule, we are proposing to revise § 414.1325(d) for purposes of the 2020 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 proposed rule for further discussion of this proposal.

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 finalized 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.

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. As discussed in section II.C.4.d. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups. We are not proposing any changes to this policy in this proposed rule. However, we are requesting comment 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 are requesting comments on recommended minimum threshold percentages and whether we should establish different thresholds based on the size of the group. For example, in considering different thresholds we could attribute recognition as a certified or recognized patient-centered medical home or comparable specialty practice at the individual TIN/NPI level, and attribute this designation to the group under which they bill if they are participating in MIPS as a group or as part of a virtual group. A group or virtual group consisting of 100 NPIs could have a reporting threshold of 50 percent while a group consisting of 10 NPIs could have a lower reporting threshold of 10 percent. 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 are requesting comments 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. We seek comment on how we could measure performance and improvement; we are 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.

(b) Submission Criteria

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. In addition, as discussed in section II.C.4.d. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups.

We established exceptions to the above for: small practices; practices located in rural areas; practices located in geographic HPSAs; non-patient facing Start Printed Page 30054individual 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. 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.

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. If by our assessment the MIPS APM does not receive the maximum improvement activities performance category score then the APM entity can submit additional improvement activities. 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. We refer readers to section II.C.6.g. of this proposed rule for further discussion of the APM scoring standard.

We also provided 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 also noted in the CY 2017 Quality Payment Program final rule that practices may receive this designation at a practice level and that TINs may be comprised of both undesignated practices and designated practices (81 FR 77178). 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 that is a certified patient-centered medical home or comparable specialty practice. 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. Accordingly, we propose 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 requirement that only one practice site within a TIN needs to be certified as a patient-centered medical home, but does not require every site be certified, which could be overly restrictive given that some sites within a TIN may be in the process of being certified as patient-centered medical homes. In addition, we believe a 50 percent threshold is achievable which 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. 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, as discussed in section II.C.4.d. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups. Further, we welcome 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.

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 is therefore a certified or recognized patient-centered medical home for purposes of the improvement activities performance category. The CPC+ model meets the criteria to be an Advanced APM. CPC+ eligibility criteria for practices include, but are not limited to, the use of CEHRT and care delivery activities such as: Assigning patients to clinician panels; providing 24/7 clinician access; and supporting quality improvement activities. Control groups in CPC+ are required to meet the same eligibility criteria as those selected to be active participants in the model. For Round 2 of CPC+, CMS is randomly assigning accepted practices into the intervention group or a control group. Practices accepted into CPC+ and randomized into the control group have satisfied the requirements for participation in CPC+, a medical home model, and we believe that the MIPS eligible clinicians in the control group should therefore receive full credit for the improvement activities performance category. In addition, the practices randomized to the CPC+ control group must sign a Participation Agreement with us; the agreement will require practices in a control group to maintain a Practitioner Roster of all MIPS eligible clinicians in the practice.

Accordingly, we are proposing that MIPS eligible clinicians in practices that have been 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. 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. The inclusion of MIPS eligible clinicians in practices that have been randomized into the CPC+ control group recognizes that they have met the Start Printed Page 30055requirements to receive full credit for performance in the improvement activities performance category as a medical home model, and will help ensure more equitable treatment of the CPC+ control group by allowing clinicians in the control group that have met the criteria for participation in the CPC+ APM to receive the same recognition as those actively participating in the CPC+ intervention group.

We request comments on these proposals.

(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 performance period as long as an activity is being performed for at least 90 days during the performance period. In addition, as discussed in section II.C.4.d. of this proposed rule, we are proposing to generally apply our previously finalized and proposed group policies to virtual groups. We are not proposing any changes to the required period of time for performing an activity for the improvement activities performance category in this proposed rule.

(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. We are not proposing any changes to the application of improvement activities to non-patient facing individual MIPS eligible clinicians and groups for the improvement activities performance category in this proposed rule.

(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. Lastly, we finalized the following definitions at § 414.1305: (1) Small practices is defined to mean practices consisting of 15 or fewer clinicians and solo practitioners; and (2) Health Professional Shortage Areas (HPSA) refers to areas as designated under section 332(a)(1)(A) of the Public Health Service Act. We are not proposing any changes to the special consideration for small, rural, or health professional shortage areas practices for the improvement activities performance category in this proposed rule.

(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 at § 414.1365 the following additional subcategories: Achieving Health Equity; Integrated Behavioral and Mental Health; and Emergency Preparedness and Response. We are not proposing any changes to the improvement activities subcategories for the improvement activities performance category in this proposed rule.

(7) Improvement Activities Inventory

(a) Proposed Approach on the Annual Call for Activities Process for Adding New Activities

In Table H in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77817), we finalized the Improvement Activities Inventory for MIPS. In addition, through subregulatory guidance 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. During this transition period we 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/​CallForMeasures.html. We are proposing new activities and changes to the Improvement Activities Inventory in Tables F and G of the Appendix of this proposed rule.

For the Quality Payment Program Year 3 and future years, we are proposing to formalize an Annual Call for Activities process for adding possible new activities to 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. We propose 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 utilized in the transition year of MIPS found on the Quality Payment Program Web site at www.qpp.cms.gov. As part of the process, individual MIPS eligible clinicians, groups, and other relevant stakeholders would be able to nominate additional improvement activities that we may consider adding to the Improvement Activities Inventory. Individual MIPS eligible clinicians and groups and relevant stakeholders would be able to provide an explanation via the nomination form of how the improvement activity meets all the criteria we have identified in section II.C.6.e.(7)(b) of this proposed rule. The 2018 proposed new improvement activities and the 2018 proposed improvement activities with changes can be found in Tables F and G of the Appendix of this proposed rule and will be available on the CMS Web site.

We request comments on this proposed annual Call for Activities process.

(b) Criteria for Nominating New Improvement Activities for the Annual Call for Activities

We propose for the Quality Payment Program Year 2 and future years that stakeholders would apply one or more of the following criteria when submitting improvement activities in response to the Annual Call for Activities:

  • Relevance to an existing improvement activities subcategory (or a proposed new subcategory);
  • Importance of an activity toward achieving improved beneficiary health outcome;Start Printed Page 30056
  • 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 note that in future rulemaking, activities that overlap with other performance categories may be included if such activities support the key goals of the program.

We request comments on this proposal.

(c) Submission Timeline for Nominating New Improvement Activities for the Annual Call for Activities

It is our intention that the nomination and acceptance process will, to the best extent possible, parallel the Annual Call for Measures process already conducted for MIPS quality measures. Aligned with this approach, we propose 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. This list will be considered by us and may include federal partners in collaboration with stakeholders. The IAUR list will be analyzed with consideration of the proposed criteria for inclusion of improvement activities in the Improvement Activities Inventory. In addition, we propose that for the 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. This proposal is 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). We are not proposing that improvement activities undergo MAP review. Therefore, our intention is to close the Annual Call for Activities submissions by March 1 before the applicable performance period, which will enable us to propose the new improvement activities for adoption in the same year's rulemaking cycle for implementation in the following year. For example, an improvement activity submitted prior to March 1, 2018, would be considered for performance periods occurring in 2019. In addition, we propose that we will add new improvement activities to the inventory through notice-and-comment rulemaking. 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 are requesting comments on what criteria should be used to identify improvement activities for removal from the Improvement Activities Inventory.

(8) 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.

We are not proposing any changes to the approach for adding new subcategories for the improvement activities performance category in this proposed rule. However, we are proposing that in future years of the Quality Payment Program we will add new improvement activities subcategories through notice-and-comment rulemaking. In addition, we are seeking comments on new improvement activities subcategories.

A number of 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. We are seeking suggestions on how a health IT subcategory within the improvement activities performance category could be structured to afford MIPS eligible clinicians with flexible opportunities to gain experience in using CEHRT and other health IT to improve their practice. Should the current policies where improvement activities earn bonus points within the advancing care information performance category be enhanced? Are there additional policies that should be explored in future rulemaking? We welcome public comment on this potential health IT subcategory.

(9) CMS Study on Burdens Associated With Reporting Quality Measures

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. We are modifying the name of the study in this proposed rule 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 also noted that study participants would receive full credit in the improvement activities performance category after successfully electing, participating, and submitting data to the study coordinators at CMS for the full calendar year (81 FR 77196). We requested comment on the study, and received generally supportive feedback for the study.

We are not proposing any changes to the study purpose. We are proposing changes to the study participation credit and requirements sample size, how the study sample is categorized into groups, and the frequency of quality data submission, focus groups, and surveys. In addition to performing descriptive statistics to compare the trends in errors and burden between study years 2017 and 2018, we would like to perform a more rigorous statistical analysis with the 2018 data, which will require a larger sample size. We propose this increase in the sample size for 2018 to Start Printed Page 30057provide the minimum sample needed to get a significant result with adequate power for the following investigation.

Specifically, we are interested in whether there are any significant differences in quality measurement data submission errors and/or clinician burdens between rural clinicians submitting either individually or as a group, and urban clinicians submitting as an individual or as a group. A statistical power analysis was performed and a total sample size of 118 will be adequate for the main objective of the study. However, allowance will be made to account for attrition and other additional (or secondary) analysis.

This analysis would be compared at different sizes of practices (<3 eligible clinicians, between 3-8 eligible clinicians, etc.). This assessment is important since it facilitates tracing the root causes of measurement burdens and data submission errors that may be associated with any sub-group of clinician practice. This comparison may further break the sample down into more than four categories and a much larger sample size is a requisite for significant results with adequate probability of certainty.

The sample size for performance periods occurring in 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.

We are proposing to increase the sample size for the performance periods occurring in 2018 to a minimum of:

  • 20 urban individual or groups of <3 eligible clinicians—(broken down into 10 individuals & 10 groups).
  • 20 rural individual or groups of <3 eligible clinicians—(broken down into 10 individuals & 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 & 3 rural).
  • 6 specialty groups—(broken down into 3 reporting individually & 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).

In addition, we are proposing changes to the study procedures. In the transition year of MIPS, study participants were required to attend a monthly focus group to share lessons learned in submitting quality data along with providing survey feedback to monitor effectiveness. However, an individual MIPS eligible clinician or group who chooses to report all 6 measures within a period of 90 days may not need to be a part of all of the focus groups and survey sessions after their first focus group and survey following the measurement data submission. This is because they may have nothing new to contribute in terms of discussion of errors or clinician burdens. This also applies to MIPS eligible clinicians that submit only three MIPS measures within the performance period, if they submitted all three measures within the 90-day period or at one submission. All study participants would participate in surveys and focus group meetings at least once after each measures data submission. For those who elect to report data for a 90-day period, we would make further engagement optional. Therefore, we are proposing that for Quality Payment Program Year 2 and future years that study participants would be required to attend as frequently as four monthly surveys and focus group sessions throughout the year, but certain study participants would be able to attend less frequently.

Further, the CY 2017 study requires study measurement data to be collected at baseline and at every 3 months (quarterly basis) afterwards for the duration of the calendar year. It also calls for a minimum requirement of three MIPS quality measures four times within the year. We believe this is inconsistent with clinicians reporting a full year's data as we believe some study participants may choose to submit data for all measures at one time, or alternatively, may choose to submit data up to six times during the 1-year period. We are proposing for the Quality Payment Program Year 2 and future years to offer study participants flexibility in their submissions so that they could submit once, as can occur in the MIPS program, and participate in study surveys and focus groups while still earning improvement activities credit.

It must be noted that although the aforementioned activities constitute an information collection request as defined in the implementing regulations of the Paperwork Reduction Act of 1995 (5 CFR 1320), the associated burden is exempt from application of the Paperwork Reduction Act. Specifically, section 1848(s)(7) of the Act, as added by section 102 of the MACRA (Pub. L. 114-10) states that Chapter 35 of title 44, United States Code, shall not apply to the collection of information for the development of quality measures. Our goals for new measures are to develop new high quality, low cost measures that are meaningful, easily understandable and operable, and also, reliably and validly measure what they purport. This study shall inform us (and our contractors) on the root causes of clinicians' performance measure data collection and data submission burdens and challenges that hinders accurate and timely quality measurement activities. In addition, this study will inform us on the characteristic attributes that our new measures must possess to be able to accurately capture and measure the priorities and gaps MACRA aims for, as described in the Quality Measures Development Plan.[2] This study, therefore, serves as the initial stage of developing new measures and also adapting existing measures. We believe that understanding clinician's challenges and skepticisms, and especially, understanding the factors that undermine the optimal functioning and effectiveness of quality measures are requisites of developing measures that are not only measuring what it purports but also that are user friendly and understandable for frontline clinicians—our main stakeholders in measure development. This will lead to the creation of practice-derived, tested measures that reduces burden and create a culture of continuous improvement in measure development.

We request comments on our study on burdens associated with reporting quality measures proposals regarding sample size for the performance periods occurring in 2018, study procedures for the performance periods occurring in 2018 and future years, and data submissions for the performance periods occurring in 2018 and future years.

f. Advancing Care Information Performance Category

(1) Background

Section 1848(q)(2)(A) of the Act includes the meaningful use of CEHRT as a performance category under the MIPS. We refer to this performance Start Printed Page 30058category as the advancing care information performance category, and it is reported by MIPS eligible clinicians as part of the overall MIPS program. As required by sections 1848(q)(2) and (5) of the Act, the four performance categories of the MIPS shall be used in determining the MIPS final score for each MIPS eligible clinician. In general, MIPS eligible clinicians will be evaluated under all four of the MIPS performance categories, including the advancing care information performance category.

(2) Scoring

Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of the MIPS final score shall be based on performance for the advancing care information performance category. We established at § 414.1380(b)(4) that the score for the advancing care information performance category would be comprised of a base score, performance score, and potential bonus points for reporting on certain measures and activities. For further explanation of our scoring policies for the advancing care information performance category, we refer readers to 81 FR 77216-77227.

(a) Base Score

For the CY 2018 performance period, we are not proposing any changes to the base score methodology as established in the CY 2017 Quality Payment Program final rule (81 FR 77217-77223). We established the policy that MIPS eligible clinicians must report a numerator of at least one for the numerator/denominator measures, or a “yes” response for the yes/no measure in order to earn the 50 percentage points in the base score. In addition, if the base score requirements are not met, a MIPS eligible clinician would receive a score of zero for the ACI performance category.

(b) Performance Score

In the CY 2017 Quality Payment Program final rule (81 FR 77223 through 77226), we finalized that MIPS eligible clinicians can earn 10 percentage points in the performance score for meeting the Immunization Registry Reporting Measure. We believe we should modify this policy because we have learned that there are areas of the country where immunization registries are not available, and we did not intend to disadvantage MIPS eligible clinicians practicing in those areas. Thus, we are proposing to modify the scoring of the Public Health and Clinical Data Registry Reporting objective beginning with the performance period in CY 2018. We propose if a MIPS eligible clinician fulfills the Immunization Registry Reporting Measure, the MIPS eligible clinician would earn 10 percentage points in the performance score. If a MIPS eligible clinician cannot fulfill the Immunization Registry Reporting Measure, we are proposing that the MIPS eligible clinician could earn 5 percentage points in the performance score for each public health agency or clinical data registry to which the clinician reports for the following measures, up to a maximum of 10 percentage points: Syndromic Surveillance Reporting; Electronic Case Reporting; Public Health Registry Reporting; and Clinical Data Registry Reporting. A MIPS eligible clinician who chooses to report to more than one public health agency or clinical data registry may receive credit in the performance score for the submission to more than one agency or registry; however, the MIPS eligible clinician would not earn more than a total of 10 percentage points for such reporting.

We further propose similar flexibility for MIPS eligible clinicians who choose to report the measures specified for the Public Health Reporting Objective of the 2018 Advancing Care Information Transition Objective and Measure set. (In section II.C.6.f.(6)(b) of this proposed rule, we are proposing to allow MIPS eligible clinicians to report using the 2018 Advancing Care Information Transition Objectives and Measures in 2018.) We propose if a MIPS eligible clinician fulfills the Immunization Registry Reporting Measure, the MIPS eligible clinician would earn 10 percentage points in the performance score. If a MIPS eligible clinician cannot fulfill the Immunization Registry Reporting Measure, we are proposing that the MIPS eligible clinician could earn 5 percentage points in the performance score for each public health agency or specialized registry to which the clinician reports for the following measures, up to a maximum of 10 percentage points: Syndromic Surveillance Reporting; Specialized Registry Reporting. A MIPS eligible clinician who chooses to report to more than one specialized registry or public health agency to submit syndromic surveillance data may earn 5 percentage points in the performance score for reporting to each one, up to a maximum of 10 percentage points.

By proposing to expand the options for fulfilling the Public Health and Clinical Data Registry Reporting and the Public Health Reporting objectives, we believe that we are adding flexibility so that additional MIPS eligible clinicians can successfully fulfill this objective and earn 10 percentage points in the performance score. We are not proposing to change the maximum performance score that a MIPS eligible clinician can earn; it remains at 90 percent.

We are inviting public comment on these proposals.

(c) Bonus Score

In the CY 2017 Quality Payment Program final rule (81 FR 77220 through 77226), for the Public Health and Clinical Data Registry Reporting objective and the Public Health Reporting objective, we finalized that MIPS eligible clinicians who report to one or more public health agencies or clinical data registries beyond the Immunization Registry Reporting Measure will earn a bonus score of 5 percentage points in the advancing care information performance category. (In section II.C.6.f.(6)(b) of this proposed rule, we are proposing to allow MIPS eligible clinicians to report using the 2018 Advancing Care Information Transition Objectives and Measures in 2018.) Based on our proposals above to allow MIPS eligible clinicians who cannot fulfill the Immunization Registry Reporting Measure to earn additional points in the performance score, we believe we should modify this policy so that MIPS eligible clinicians cannot earn points in both the performance score and bonus score for reporting to the same public health agency or clinical data registry. We are proposing to modify our policy beginning with the performance period in CY 2018. We are proposing that a MIPS eligible clinician may only earn the bonus score of 5 percentage points for reporting to at least one additional public health agency or clinical data registry that is different from the agency/agencies or registry/or registries to which the MIPS eligible clinician reports to earn a performance score. For example, if a MIPS eligible clinician reports to a public health agency and a clinical data registry for the performance score, they could earn the bonus score of 5 percentage points by reporting to a different agency or registry that the clinician did not identify for purposes of the performance score. A MIPS eligible clinician would not receive credit under both the performance score and bonus score for reporting to the same agency or registry.

We are proposing that for the Advancing Care Information Objectives and Measures, a bonus of 5 percentage points would be awarded if the MIPS eligible clinician reports “yes” for any one of the following measures associated with the Public Health and Clinical Data Registry Reporting Start Printed Page 30059objective: Syndromic Surveillance Reporting; Electronic Case Reporting; Public Health Registry Reporting; or Clinical Data Registry Reporting. We are proposing that for the 2018 Advancing Care Information Transition Objectives and Measures, a bonus of 5 percent would be awarded if the MIPS eligible clinician reports “yes” for any one of the following measures associated with the Public Health Reporting objective: Syndromic Surveillance Reporting or Specialized Registry Reporting. We are proposing that to earn the bonus score, the MIPS eligible clinician must be in active engagement with one or more additional public health agencies or clinical data registries that is/are different from the agency or registry that they identified to earn a performance score.

We are inviting public comment on this proposal.

(d) Improvement Activities Bonus Score Under the Advancing Care Information Performance Category

In the CY 2017 Quality Payment Program final rule (81 FR 77202), we discussed our approach to the measurement of the use of health IT to allow MIPS eligible clinicians and groups the flexibility to implement health IT in a way that supports their clinical needs. In addition, we discussed the need to move toward measurement of health IT use with respect to its contribution to effective care coordination and improving outcomes for patients. We stated that this approach would allow us to more directly link health IT adoption and use to patient outcomes, moving MIPS beyond the measurement of EHR adoption and process measurement and into a more patient-focused health IT program. Toward that end, we adopted a policy to award a bonus score to MIPS eligible clinicians who use CEHRT to complete certain activities in the improvement activities performance category based on our belief that the use of CEHRT in carrying out these activities could further the outcomes of clinical practice improvement.

We adopted a final policy to award a 10 percent bonus for the advancing care information performance category if a MIPS eligible clinician attests to completing at least one of the improvement activities we have specified using CEHRT (81 FR 77209). We refer readers to Table 8 in the CY 2017 Quality Payment Program final rule (81 FR 77202-77209) for a list of the improvement activities eligible for the advancing care information performance category bonus. In this proposed rule, we are proposing to expand this policy beginning with the CY 2018 performance period by identifying additional improvement activities in Table 6 that would be eligible for the advancing care information performance category bonus score if they are completed using CEHRT functionality. The activities eligible for the bonus score would include those listed in Table 6, as well as those listed in Table 8 in last year's final rule. We refer readers to the Improvement Activities section of this proposed rule (section II.C.6.e. of this proposed rule) for a discussion of the proposed new improvement activities and proposed changes to the improvement activities for 2018.

Ten percentage points is the maximum bonus a MIPS eligible clinician would receive if they attest to using CEHRT for one or more of the activities we have identified as eligible for the bonus. This bonus is intended to support progression toward holistic health IT use and measurement; attesting to even one improvement activity demonstrates that the MIPS eligible clinician is working toward this holistic approach to the use of their CEHRT. The weight of the improvement activity for the improvement activities performance category has no effect on the bonus awarded in the advancing care information performance category.

We invite comment on this proposal.

Start Printed Page 30060

Start Printed Page 30061

Start Printed Page 30062

Start Printed Page 30063

(3) Performance Periods for the Advancing Care Information Performance Category

In the CY 2017 Quality Payment Program final rule (81 FR 77210 through 77211), we established a performance period for the advancing care information performance category to align with the overall MIPS performance period of one full year to ensure all four performance categories are measured and scored based on the same period of time. We believe this will lower reporting burden, focus clinician quality improvement efforts and align administrative actions so that MIPS eligible clinicians can use common systems and reporting pathways. We stated for the first and second performance periods of MIPS (CYs 2017 and 2018), we will accept a minimum of 90 consecutive days of data and encourage MIPS eligible clinicians to report data for the full year performance period. We are maintaining this policy as finalized for the performance period in CY 2018, and will accept a minimum of 90 consecutive days of data in CY 2018. We are proposing the same policy for the advancing care information performance category for the performance period in CY 2019, Quality Payment Program Year 3, and would accept a minimum of 90 consecutive days of data in CY 2019. We refer readers to section II.C.5. in this proposed rule for additional information on the MIPS performance period.

(4) Certification Requirements

In the CY 2017 Quality Payment Program final rule (81 FR 77211 through 77213), we outlined the requirements for MIPS eligible clinicians using CEHRT during the CY 2017 performance period for the advancing care information performance category as it relates to the objectives and measures they select to report, and also outlined requirements for the CY 2018 performance period. We additionally adopted a definition of CEHRT at § 414.1305 for MIPS eligible clinicians that is based on the definition that applies in the EHR Incentive Programs under § 495.4.

For the CY 2017 performance period, we adopted a policy by which MIPS eligible clinicians may use EHR Start Printed Page 30064technology certified to either the 2014 or 2015 Edition certification criteria, or a combination of the two. For the CY 2018 performance period, we previously stated that MIPS eligible clinicians must use EHR technology certified to the 2015 Edition to meet the objectives and measures specified for the advancing care information performance category.

We received significant comments and feedback from stakeholders requesting that we extend the use of 2014 Edition CEHRT beyond CY 2017 into CY 2018 and even CY 2019. Many commenters noted the lack of products certified to the 2015 Edition. Others stated that switching from the 2014 Edition to the 2015 Edition requires a large amount of time and planning and if it is rushed there is a potential risk to patient health. Some commenters noted the significant burden of combining outputs from multiple CEHRTs. A few mentioned that the cost to switch to the 2015 Edition is prohibitive for smaller practices.

Our experience with the transition from EHR technology certified to the 2011 Edition to EHR technology certified to the 2014 Edition did make us aware of the many issues associated with the adoption of EHR technology certified to a new Edition. These include the time that will be necessary to effectively deploy EHR technology certified to the 2015 Edition standards and certification criteria and to make the necessary patient safety, staff training, and workflow investments to be prepared to report for the advancing care information performance category for 2018. We understand and appreciate these concerns, and are working in collaboration with our federal partners at the Office of the National Coordinator for Health Information Technology (ONC) to monitor progress on the 2015 Edition upgrade.

As noted in the FY 2018 Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System proposed rule (referred to as the FY 2018 IPPS/LTCH PPS proposed rule) (82 FR 20136), ONC is working with health IT developers to analyze and monitor the status of developer readiness for 2015 Edition technology. As part of these analyses, ONC also reviewed health IT being certified to 2015 Edition by health IT developers who have products that were certified for the 2014 Edition and were used by EHR Incentive Program participants to attest. This analysis compared the pace of 2014 Edition certification with the pace of 2015 Edition certification to date. As of the beginning of the second quarter of CY 2017, ONC confirmed that at least 53 percent of eligible clinicians and 80 percent of eligible hospitals have 2015 Edition certified EHR technology available based on previous EHR Incentive Programs attestation data. Based on these data, and as compared to the transition from 2011 Edition to 2014 Edition, it appears that the transition from the 2014 Edition to the 2015 Edition is on schedule for the CY 2018 performance period.

However, the analysis also considered market trends such as consolidation and the number of large and small developers covering various groups of participants and the potential impact on readiness. The eligible hospital market is fairly concentrated, with nearly 98 percent of eligible hospital EHR Incentive Program participants using health IT from the top ten developers (ranked by market share) with a significant majority of that coverage by the top five developers. For hospitals, some developers representing a smaller market share also have certified health IT already available and are not expected to have a release schedule much different from their larger competitors. Considering market factors and using previous EHR Incentive Programs attestation data, ONC estimates that at least 85 percent of eligible hospitals would have EHR technology certified to the 2015 Edition available for use by the end of CY 2017 for program participation in 2018. In the FY 2018 IPPS/LTCH PPS proposed rule (82 FR 20136), we proposed to shorten the EHR reporting period to a minimum of any continuous 90-day period within CY 2018 for eligible hospitals and CAHs, as well as EPs who attest for a state's Medicaid EHR Incentive Program, to allow additional time for successful implementation of EHR technology certified to the 2015 Edition in CY 2018.

For MIPS eligible clinicians, the concern of potential impact on participation readiness when reviewing these market factors may be more significant. As noted in the FY 2018 IPPS/LTCH PPS proposed rule (82 FR 20136), historical data indicates eligible professionals were more likely to use a wider range of certified health IT, including those which individually make up a smaller segment of the overall market. Therefore, when market factors are taken into account, there exists a larger proportion of readiness that is unknown due to the wider range of certified health IT which may be used by MIPS eligible clinicians. This necessitated a more conservative approach for MIPS eligible clinician readiness. That estimate is that 74 percent of MIPS eligible clinicians will be ready to participate in MIPS using 2015 Edition certified EHR technologies by January 1, 2018.

However, subsequent to the preliminary analysis, ONC has continued to monitor readiness and to receive feedback from stakeholders on factors influencing variations in the development and implementation timelines for developers supporting different segments of the market, as well as the relationship between the developer readiness timeline and participant readiness. This continuing analysis supports a potential need for a longer implementation timeline for MIPS eligible clinicians. Stakeholder feedback suggests that while the estimate for known readiness remains the same, readiness among the remaining MIPS eligible clinicians may not be on the same timeline. About one quarter of eligible professional EHR Incentive Program participants in prior years used certified health IT from small developers that each has an historical market share of 1 percent or less. Therefore, MIPS eligible clinicians will need a significant number of smaller developers to reach the same readiness on the same timeline as larger companies in order to support program participants seeking to upgrade to the 2015 Edition. However, small developers generally offer a limited number or type of products, and may have more limited resources to dedicate to upgrade development, testing and certification, and implementation, which may affect availability and timing. In addition, the same factors may impact the capacity of some developers to support participants during the process and therefore the timeline for participant readiness would also potentially be longer. This is supported by historical analysis as a smaller percentage of eligible professionals used 2014 Edition certified EHR technology for participation in the EHR Incentive Programs during the 2014 calendar year than eligible hospitals and CAHs for the same year. For this reason, we believe additional flexibility for MIPS eligible clinicians is essential to support successful participation in the advancing care information performance category.

We continue to believe that there are many benefits for switching to EHR technology certified to the 2015 Edition. As noted in the FY 2018 IPPS/LTCH PPS proposed rule (82 FR 20136), the 2015 Edition health IT certification criteria enables health information exchange through new and enhanced certification criteria standards, and through implementation specifications Start Printed Page 30065for interoperability. The 2015 Edition also incorporates changes that are designed to spur innovation and provide more choices to health care providers and patients for the exchange of electronic health information, including new Application Programming Interface (API) certification criteria. APIs are required for patient engagement measures within the advancing care information category; however, they may also be enabled by a health care provider or organization for their own use of third party applications with their CEHRT, such as for quality improvement. An API can also be enabled by a health care provider to give patients access to their health information through a third-party application with more flexibility than is often found in many current patient portals. From the MIPS eligible clinician perspective, an API could complement a patient portal or could also potentially make one unnecessary if patients are able to use software applications designed to interact with an API that could support their ability to view, download, and transmit their health information to a third party. In addition, the 2015 Edition health IT transitions of care certification criterion rigorously assesses a product's ability to create and receive a Consolidated-Clinical Document Architecture (C-CDA) formatted documents. The ONC also adopted certification criteria that both support interoperability in other settings and use cases, such as the Common Clinical Data Set summary record, data segmentation for privacy, and care plan certification criteria (80 FR 62603).

However, in light of the conservative readiness estimates for MIPS eligible clinicians, and in line with our commitment to supporting small practices, solo practitioners and specialties which may be more likely to use certified health IT offered by small developers, we are proposing that MIPS eligible clinicians may use EHR technology certified to either the 2014 or 2015 Edition certification criteria, or a combination of the two for the CY 2018 performance period. We propose to amend § 414.1305 to reflect this change. We further note, that to encourage new participants to adopt certified health IT and to incentivize participants to upgrade their technology to 2015 Edition products which better support interoperability across the care continuum, we are proposing to offer a bonus of 10 percentage points under the advancing care information performance category for MIPS eligible clinicians who report the Advancing Care Information Objectives and Measures for the performance period in CY 2018 using only 2015 Edition CEHRT. We are proposing to amend § 414.1380(b)(4)C)(3) to reflect this change. We are proposing this one-time bonus for CY 2018 to support and recognize MIPS eligible clinicians and groups that invest in implementing certified EHR technology in their practice. Specifically, we intend this bonus to support new participants that may be adopting health IT for the first time in CY 2018 and do not have 2014 Edition technology available to use or that may have no prior experience with meaningful use objectives and measures. We believe this bonus will help recognize their investment to adopt health IT and support their participation in the advancing care information performance category in MIPS. In addition, we believe this bonus will help to incentivize participants to continue the process of upgrading from 2014 Edition to 2015 Edition, especially small practices where the investment in updated workflows and implementation may present unique challenges. We intend this bonus to support and recognize their efforts to engage with the advancing care information measures using technology certified to the 2015 Edition, which include more robust measures using updated standards and functions which support interoperability. We seek comment on this proposed bonus. Specifically, we seek comment on if the percentage of the bonus is appropriate, or whether it should be limited to new participants in MIPS and small practices.

This bonus is not available to MIPS eligible clinicians who use a combination of the 2014 and 2015 Editions. We note that with the addition of the 2015 Edition CEHRT bonus of 10 percentage points, MIPS eligible clinicians would be able to earn a bonus score of up to 25 percentage points in CY 2018 under the advancing care information performance category, an increase from the 15 percentage point bonus score available in CY 2017.

To facilitate readers in identifying the requirements of CEHRT for the Advancing Care Information Objectives and Measures, we are including Table 8 in section II.C.6.f.(6)(a) which lists the 2015 Edition and 2014 Edition certification criteria required to meet the objectives and measures.

We invite comments on these proposals.

(5) Scoring Methodology Considerations

Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of the MIPS final score shall be based on performance for the advancing care information performance category. Further, section 1848(q)(5)(E)(ii) of the Act, provides that in any year in which the Secretary estimates that the proportion of eligible professionals (as defined in section 1848(o)(5) of the Act) who are meaningful EHR users (as determined under section 1848(o)(2) of the Act) is 75 percent or greater, the Secretary may reduce the applicable percentage weight of the advancing care information performance category in the MIPS final score, but not below 15 percent, and increase the weightings of the other performance categories such that the total percentage points of the increase equals the total percentage points of the reduction. We note that section 1848(o)(5) of the Act defines an eligible professional as a physician, as defined in section 1861(r) of the Act.

In CY 2017 Quality Payment Program final rule (81 FR 77226-77227), we established a final policy, for purposes of applying section 1848(q)(5)(E)(ii) of the Act, to estimate the proportion of physicians as defined in section 1861(r) of the Act who are meaningful EHR users as those physician MIPS eligible clinicians who earn an advancing care information performance category score of at least 75 percent for a performance period. We established that we will base this estimation on data from the relevant performance period, if we have sufficient data available from that period. For example, if feasible, we would consider whether to reduce the applicable percentage weight of the advancing care information performance category in the MIPS final score for the 2019 MIPS payment year based on an estimation using the data from the 2017 performance period. We stated that we will not include in the estimation physicians for whom the advancing care information performance category is weighted at zero percent under section 1848(q)(5)(F) of the Act, which we relied on in the CY 2017 Quality Payment Program final rule (81 FR 77226 through 77227) to establish policies under which we would weigh the advancing care information performance category at zero percent of the final score. In addition, we are proposing not to include in the estimation physicians for whom the advancing care information performance category would be weighted at zero percent under our proposal in section II.C.6.f.(7) of this proposed rule to implement certain provisions of the 21st Century Cures Act (that is, physicians who are determined hospital-based or ambulatory surgical center-based, or who are granted an exception based on Start Printed Page 30066significant hardship or decertified EHR technology.

We are considering modifications to the policy we established in last year's rulemaking to base our estimation of physicians who are meaningful EHR users for a MIPS payment year (for example, 2019) on data from the relevant performance period (for example, 2017). We are concerned that if in future rulemaking we decide to propose to change the weight of the advancing care information performance category based on our estimation, such a change may cause confusion to MIPS eligible clinicians who are adjusting to the MIPS program and believe this performance category will make up 25 percent of the final score for the 2019 MIPS payment year. The earliest we would be able to make our estimation based on 2017 data and propose in future rulemaking to change the weight of the advancing care information performance category for the 2019 MIPS payment year would be in mid-2018, as the deadline for data submission is March 31, 2018. We are requesting public comments on whether this timeframe is sufficient, or whether a more extended timeframe would be preferable. We are proposing to modify our existing policy such that we would base our estimation of physicians who are meaningful EHR users for a MIPS payment year on data from the performance period that occurs four years before the MIPS payment year. For example, we would use data from the 2017 performance period to estimate the proportion of physicians who are meaningful EHR users for purposes of reweighting the advancing care information performance category for the 2021 MIPS payment year.

We invite comments on this proposal.

(6) Objectives and Measures

(a) Advancing Care Information Objectives and Measures Specifications

We are proposing to maintain for the CY 2018 performance period the Advancing Care Information Objectives and Measures as finalized in the CY 2017 Quality Payment Program final rule (81 FR 77227 through 77229) with the modifications proposed below. As we noted (81 FR 77227), these objectives and measures were adapted from the Stage 3 objectives and measures finalized in the 2015 EHR Incentive Programs final rule (80 FR 62829 through 62871), however, we did not maintain the previously established thresholds for MIPS. For a more detailed discussion of the Stage 3 objectives and measures, including explanatory material and defined terms, we refer readers to the 2015 EHR Incentive Programs final rule (80 FR 62829 through 62871).

Start Printed Page 30067

Start Printed Page 30068

Objective: Protect Patient Health Information.

Objective: Protect electronic protected health information (ePHI) created or maintained by the CEHRT through the implementation of appropriate technical, administrative, and physical safeguards.

Security Risk Analysis Measure: Conduct or review a security risk analysis in accordance with the requirements in 45 CFR 164.308(a)(1), including addressing the security (to include encryption) of ePHI data created or maintained by CEHRT in accordance with requirements in 45 CFR 164.312(a)(2)(iv) and 164.306(d)(3), implement security updates as necessary, and correct identified security deficiencies as part of the MIPS eligible clinician's risk management process.

Objective: Electronic Prescribing.

Objective: Generate and transmit permissible prescriptions electronically.

E-Prescribing Measure: At least one permissible prescription written by the MIPS eligible clinician is queried for a drug formulary and transmitted electronically using CEHRT.

  • Denominator: Number of prescriptions written for drugs requiring a prescription to be dispensed other than controlled substances during the performance period; or number of prescriptions written for drugs requiring a prescription to be dispensed during the performance period.
  • Numerator: The number of prescriptions in the denominator generated, queried for a drug formulary, and transmitted electronically using CEHRT.

Objective: Patient Electronic Access.

Objective: The MIPS eligible clinician provides patients (or patient-authorized representative) with timely electronic access to their health information and patient-specific education.

Provide Patient Access Measure: For at least one unique patient seen by the MIPS eligible clinician: (1) The patient (or the patient-authorized representative) is provided timely access to view online, download, and transmit his or her health information; and (2) The MIPS eligible clinician ensures the patient's health information is available for the patient (or patient-authorized representative) to access using any application of their choice that is configured to meet the technical specifications of the Application Programing Interface (API) in the MIPS eligible clinician's CEHRT.

  • Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.
  • Numerator: The number of patients in the denominator (or patient authorized representative) who are provided timely access to health information to view online, download, and transmit to a third party and to access using an application of their choice that is configured meet the technical specifications of the API in the MIPS eligible clinician's CEHRT.

Definition of timely—Beginning with the 2018 performance period, we are proposing to define “timely” as within 4 business days of the information being available to the MIPS eligible clinician. This definition of timely is the same as we adopted under the EHR Incentive Programs (80 FR 62815).

Patient-Specific Education Measure: The MIPS eligible clinician must use clinically relevant information from CEHRT to identify patient-specific educational resources and provide electronic access to those materials to at least one unique patient seen by the MIPS eligible clinician.

  • Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.
  • Numerator: The number of patients in the denominator who were provided electronic access to patient-specific educational resources using clinically relevant information identified from CEHRT during the performance period.

Objective: Coordination of Care Through Patient Engagement.

Objective: Use CEHRT to engage with patients or their authorized representatives about the patient's care.

View, Download, Transmit (VDT) Measure: During the performance period, at least one unique patient (or patient-authorized representatives) seen by the MIPS eligible clinician actively engages with the EHR made accessible by the MIPS eligible clinician. A MIPS eligible clinician may meet the measure by either (1) view, download or transmit to a third party their health information; or (2) access their health information through the use of an API that can be used by applications chosen by the patient and configured to the API in the MIPS eligible clinician's CEHRT; or (3) a combination of (1) and (2).

Proposed change to the View, Download, Transmit (VDT) Measure: During the performance period, at least one unique patient (or patient-authorized representatives) seen by the MIPS eligible clinician actively engages with the EHR made accessible by the MIPS eligible clinician by either (1) viewing, downloading or transmitting to a third party their health information; or (2) accessing their health information through the use of an API that can be used by applications chosen by the patient and configured to the API in the MIPS eligible clinician's CEHRT; or (3) a combination of (1) and (2). We are proposing this change because we erroneously described the actions in the measure (viewing, downloading or transmitting; or accessing through an API) as being taken by the MIPS eligible clinician rather than the patient or the patient-authorized representatives. This change would align the measure description with the requirements of the numerator and denominator. We propose this change would apply beginning with the performance period in 2017.

  • Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.
  • Numerator: The number of unique patients (or their authorized representatives) in the denominator who have viewed online, downloaded, or transmitted to a third party the patient's health information during the performance period and the number of unique patients (or their authorized representatives) in the denominator who have accessed their health information through the use of an API during the performance period.

Secure Messaging Measure: For at least one unique patient seen by the MIPS eligible clinician during the performance period, a secure message was sent using the electronic messaging function of CEHRT to the patient (or the patient-authorized representative), or in response to a secure message sent by the patient (or the patient-authorized representative).

  • Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.
  • Numerator: The number of patients in the denominator for whom a secure electronic message is sent to the patient (or patient-authorized representative) or in response to a secure message sent by the patient (or patient-authorized representative), during the performance period.

Patient-Generated Health Data Measure: Patient-generated health data or data from a non-clinical setting is incorporated into the CEHRT for at least one unique patient seen by the MIPS eligible clinician during the performance period.

  • Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.
  • Numerator: The number of patients in the denominator for whom data from non-clinical settings, which may Start Printed Page 30069include patient-generated health data, is captured through the CEHRT into the patient record during the performance period.

Objective: Health Information Exchange

Objective: The MIPS eligible clinician provides a summary of care record when transitioning or referring their patient to another setting of care, receives or retrieves a summary of care record upon the receipt of a transition or referral or upon the first patient encounter with a new patient, and incorporates summary of care information from other health care clinician into their EHR using the functions of CEHRT.

Proposed Change to the Objective: The MIPS eligible clinician provides a summary of care record when transitioning or referring their patient to another setting of care, receives or retrieves a summary of care record upon the receipt of a transition or referral or upon the first patient encounter with a new patient, and incorporates summary of care information from other health care providers into their EHR using the functions of CEHRT.

We inadvertently used the term “health care clinician” and are proposing to replace it with the more appropriate term “health care provider”. We are proposing this change would apply beginning with the performance period in 2017.

Send a Summary of Care Measure: For at least one transition of care or referral, the MIPS eligible clinician that transitions or refers their patient to another setting of care or health care clinician (1) creates a summary of care record using CEHRT; and (2) electronically exchanges the summary of care record.

Proposed Change to the Send a Summary of Care Measure: For at least one transition of care or referral, the MIPS eligible clinician that transitions or refers their patient to another setting of care or health care provider (1) creates a summary of care record using CEHRT; and (2) electronically exchanges the summary of care record.

We inadvertently used the term “health care clinician” and are proposing to replace it with the more appropriate term “health care provider”. We are proposing this change would apply beginning with the 2017 performance period.

  • Denominator: Number of transitions of care and referrals during the performance period for which the MIPS eligible clinician was the transferring or referring clinician.
  • Numerator: The number of transitions of care and referrals in the denominator where a summary of care record was created using CEHRT and exchanged electronically.

Request/Accept Summary of Care Measure: For at least one transition of care or referral received or patient encounter in which the MIPS eligible clinician has never before encountered the patient, the MIPS eligible clinician receives or retrieves and incorporates into the patient's record an electronic summary of care document.

  • Denominator: Number of patient encounters during the performance period for which a MIPS eligible clinician was the receiving party of a transition or referral or has never before encountered the patient and for which an electronic summary of care record is available.
  • Numerator: Number of patient encounters in the denominator where an electronic summary of care record received is incorporated by the clinician into the CEHRT.

Clinical Information Reconciliation Measure: For at least one transition of care or referral received or patient encounter in which the MIPS eligible clinician has never before encountered the patient, the MIPS eligible clinician performs clinical information reconciliation. The MIPS eligible clinician must implement clinical information reconciliation for the following three clinical information sets: (1) Medication. Review of the patient's medication, including the name, dosage, frequency, and route of each medication; (2) Medication allergy. Review of the patient's known medication allergies; (3) Current Problem list. Review of the patient's current and active diagnoses.

  • Denominator: Number of transitions of care or referrals during the performance period for which the MIPS eligible clinician was the recipient of the transition or referral or has never before encountered the patient.
  • Numerator: The number of transitions of care or referrals in the denominator where the following three clinical information reconciliations were performed: Medication list; medication allergy list; and current problem list.

Objective: Public Health and Clinical Data Registry Reporting.

Objective: The MIPS eligible clinician is in active engagement with a public health agency or clinical data registry to submit electronic public health data in a meaningful way using CEHRT, except where prohibited, and in accordance with applicable law and practice.

Immunization Registry Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to submit immunization data and receive immunization forecasts and histories from the public health immunization registry/immunization information system (IIS).

We note that the functionality to be bi-directional is part of EHR technology certified to the 2015 Edition (80 FR 62554). It means that in addition to sending the immunization record to the immunization registry, the CEHRT must be able to receive and display a consolidated immunization history and forecast.

Syndromic Surveillance Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to submit syndromic surveillance data from a non-urgent care ambulatory setting where the jurisdiction accepts syndromic data from such settings and the standards are clearly defined.

Proposed Change to the Syndromic Surveillance Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to submit syndromic surveillance data. We are proposing this change because we inadvertently finalized the measure description that we had proposed for Stage 3 of the EHR Incentive Program (80 FR 82866) and not the measure description that we finalized (80 FR 82970). The proposed change aligns with the measure description finalized for Stage 3.

Electronic Case Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to electronically submit case reporting of reportable conditions.

Public Health Registry Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to submit data to public health registries.

Clinical Data Registry Reporting Measure: The MIPS eligible clinician is in active engagement to submit data to a clinical data registry.

We note that we have split the Specialized Registry Reporting Measure that we adopted under the 2017 Advancing Care Information Transition Objectives and Measures into two separate measures, Public Health Registry and Clinical Data Registry Reporting to better define the registries available for reporting. We want to continue to encourage those MIPS eligible clinicians who have already started down the path of reporting to a specialized registry to continue to engage in public health and clinical data registry reporting. Therefore, we propose to allow MIPS eligible clinicians and groups to continue to count active engagement in electronic Start Printed Page 30070public health reporting with specialized registries. We propose to allow these registries to be counted for purposes of reporting the Public Health Registry Reporting Measure or the Clinical Data Registry Reporting Measure beginning with the 2018 performance period. A MIPS eligible clinician may count a specialized registry if the MIPS eligible clinician achieved the phase of active engagement as described under “active engagement option 3: production” in the 2015 EHR Incentive Programs final rule with comment period (80 FR 62862 through 62865), meaning the clinician has completed testing and validation of the electronic submission and is electronically submitting production data to the public health agency or clinical data registry.

As noted previously, to facilitate readers in identifying the requirements of CEHRT for the Advancing Care Information Objectives and Measures, we are including the following Table 8, which includes the 2015 Edition and 2014 Edition certification criteria required to meet the objectives and measures.

Table 8—Advancing Care Information Objectives and Measures and Certification Criteria for 2014 and 2015 Editions

ObjectiveMeasure2015 Edition2014 Edition
Protect Patient Health InformationSecurity Risk AnalysisThe requirements are a part of CEHRT specific to each certification criterionThe requirements are included in the Base EHR Definition.
Electronic Prescribinge-Prescribing§ 170.315(b)(3) (Electronic Prescribing). § 170.315(a)(10) (Drug-Formulary and Preferred Drug List checks§ 170.314(b)(3) (Electronic Prescribing). § 170.314(a)(10) (Drug-Formulary and Preferred Drug List checks.
Patient Electronic AccessProvide Patient Access§ 170.315(e)(1) (View, Download, and Transmit to 3rd Party). § 170.315(g)(7) (Application Access—Patient Selection). § 170.315(g)(8) (Application Access—Data Category Request). § 170.315(g)(9) (Application Access—All Data Request) The three criteria combined are the “API” certification criteria§ 170.314(e)(1) (View, Download, and Transmit to 3rd Party).
Patient Electronic AccessPatient Specific Education§ 170.315(a)(13) (Patient-specific Education Resources)§ 170.314(a)(13) (Patient-specific Education Resources).
Coordination of Care Through Patient EngagementView, Download, or Transmit (VDT)§ 170.315(e)(1) (View, Download, and Transmit to 3rd Party). § 170.315(g)(7) (Application Access—Patient Selection). § 170.315(g)(8) (Application Access—Data Category Request). § 170.315(g)(9) (Application Access—All Data Request) The three criteria combined are the “API” certification criteria§ 170.314(e)(1) (View, Download, and Transmit to 3rd Party).
Coordination of Care Through Patient EngagementSecure Messaging§ 170.315(e)(2) (Secure Messaging)§ 170.314(e)(3) (Secure Messaging).
Coordination of Care Through Patient EngagementPatient-Generated Health Data§ 170.315(e)(3) (Patient Health Information Capture) Supports meeting the measure, but is NOT required to be used to meet the measure. The certification criterion is part of the CEHRT definition beginning in 2018N/A.
Health Information ExchangeSend a Summary of Care§ 170.315(b)(1) (Transitions of Care)§ 170.314(b)(2) (Transitions of Care-Create and Transmit Transition of Care/Referral Summaries or § 170.314(b)(8) (Optional—Transitions of Care).
Health Information ExchangeRequest/Accept Summary of Care§ 170.315(b)(1) (Transitions of Care)§ 170.314(b)(1) (Transitions of Care-Receive, Display and Incorporate Transition of Care/Referral Summaries or § 170.314(b)(8) (Optional-Transitions of Care).
Health Information ExchangeClinical Information Reconciliation§ 170.315(b)(2) (Clinical Information Reconciliation and Incorporation)§ 170.314(b)(4) (Clinical Information Reconciliation or § 170.314(b)(9) (Optional—Clinical Information Reconciliation and Incorporation).
Public Health and Clinical Data Registry ReportingImmunization Registry Reporting§ 170.315(f)(1) (Transmission to Immunization Registries)N/A.
Public Health and Clinical Data Registry ReportingSyndromic Surveillance Reporting§ 170.315(f)(2) (Transmission to Public Health Agencies—Syndromic Surveillance) Urgent Care Setting Only§ 170.314(f)(3) (Transmission to Public Health Agencies—Syndromic Surveillance) or § 170.314(f)(7) (Optional-Ambulatory Setting Only-Transmission to Public Health Agencies—Syndromic Surveillance).
Public Health and Clinical Data Registry ReportingElectronic Case Reporting§ 170.315(f)(5) (Transmission to Public Health Agencies—Electronic Case Reporting)N/A.
Start Printed Page 30071
Public Health and Clinical Data Registry ReportingPublic Health Registry ReportingEPs may choose one or more of the following: § 170.315(f)(4) (Transmission to Cancer Registries) § 170.315(f)(7) (Transmission to Public Health Agencies—Health Care Surveys)§ 170.314(f)(5) (Optional—Ambulatory Setting Only—Cancer Case Information and § 170.314(f)(6) (Optional—Ambulatory Setting Only—Transmission to Cancer Registries).
Public Health and Clinical Data Registry ReportingClinical Data Registry ReportingNo 2015 Edition health IT certification criteria at this timeN/A.

We are inviting public comment on these proposals.

(b) 2017 and 2018 Advancing Care Information Transition Objectives and Measures Specifications

Table 9—Advancing Care Information Performance Category Scoring Methodology for 2018 Advancing Care Information Transition Objectives and Measures

2018 Advancing Care Information Transition Objective2018 Advancing Care Information Transition MeasureRequired/ not required for base score (50%)Performance Score (up to 90%)Reporting requirement
Protect Patient Health InformationSecurity Risk AnalysisRequired0Yes/No Statement.
Electronic PrescribingE-PrescribingRequired0Numerator/Denominator.
Patient Electronic AccessProvide Patient AccessRequiredUp to 20Numerator/Denominator.
View, Download, or Transmit (VDT)Not RequiredUp to 10Numerator/Denominator.
Patient-Specific EducationPatient-Specific EducationNot RequiredUp to 10Numerator/Denominator.
Secure MessagingSecure MessagingNot RequiredUp to 10Numerator/Denominator.
Health Information ExchangeHealth Information ExchangeRequiredUp to 20Numerator/Denominator.
Medication ReconciliationMedication ReconciliationNot RequiredUp to 10Numerator/Denominator.
Public Health ReportingImmunization Registry ReportingNot Required0 or 10Yes/No Statement.
Syndromic Surveillance ReportingNot Required0 or 5 *Yes/No Statement.
Specialized Registry ReportingNot Required0 or 5 *Yes/No Statement.
Bonus up to 15%
Report to one or more additional public health agencies or clinical data registries beyond those identified for the performance score5 bonusYes/No Statement.
Report improvement activities using CEHRT10 bonusYes/No Statement.
* A MIPS eligible clinician who cannot fulfill the Immunization Registry Reporting measure may earn 5% for each public health agency or clinical data registry to which the clinician reports, up to a maximum of 10% under the performance score.

In the CY 2017 Quality Payment Program final rule (81 FR 77229 through 77237), we finalized the 2017 Advancing Care Information Transition Objectives and Measures for MIPS eligible clinicians using EHR technology certified to the 2014 Edition. We noted (81 FR 77229 that these objectives and measures have been adapted from the Modified Stage 2 objectives and measures finalized in the 2015 EHR Incentive Programs final rule (80 FR 62793 through 62825); however, we did not maintain the previously established thresholds for MIPS. For a more detailed discussion of the Modified Stage 2 Objectives and Measures, including explanatory material and defined terms, we refer readers to the 2015 EHR Incentive Programs final rule (80 FR 62793 through 62825). We are proposing to make several modifications identified and described below to the 2017 Advancing Care Information Transition Objectives and Measures for the advancing care information performance category of MIPS for the 2017 and 2018 performance periods. These modifications would not require changes to EHR technology that has been certified to the 2014 Edition.

We finalized the 2017 Advancing Care Information Transition Objectives and Measures only for the 2017 performance period because these objectives and measures are for MIPS eligible clinicians using EHR technology certified to the 2014 Edition. Because we are proposing in section II.C.6.f.(4) to continue to allow the use of EHR technology certified to the 2014 Edition in the 2018 performance period, we are also proposing to allow MIPS eligible clinicians to report the Advancing Care Information Transition Objectives and Measures in 2018.

Objective: Protect Patient Health Information.

Objective: Protect electronic protected health information (ePHI) created or maintained by the CEHRT through the Start Printed Page 30072implementation of appropriate technical, administrative, and physical safeguards.

Security Risk Analysis Measure: Conduct or review a security risk analysis in accordance with the requirements in 45 CFR 164.308(a)(1), including addressing the security (to include encryption) of ePHI data created or maintained by CEHRT in accordance with requirements in 45 CFR 164.312(a)(2)(iv) and 164.306(d)(3), and implement security updates as necessary and correct identified security deficiencies as part of the MIPS eligible clinician's risk management process.

Objective: Electronic Prescribing.

Objective: MIPS eligible clinicians must generate and transmit permissible prescriptions electronically.

E-Prescribing Measure: At least one permissible prescription written by the MIPS eligible clinician is queried for a drug formulary and transmitted electronically using CEHRT.

  • Denominator: Number of prescriptions written for drugs requiring a prescription to be dispensed other than controlled substances during the performance period; or number of prescriptions written for drugs requiring a prescription to be dispensed during the performance period.
  • Numerator: The number of prescriptions in the denominator generated, queried for a drug formulary, and transmitted electronically using CEHRT.

Objective: Patient Electronic Access.

Objective: The MIPS eligible clinician provides patients (or patient-authorized representative) with timely electronic access to their health information and patient-specific education.

Proposed Modification to the Objective: We are proposing to modify this objective beginning with the 2017 performance period by removing the word “electronic” from the description of timely access as it was erroneously included in the final rule (81 FR 77228). It was our intention to align the objective with the objectives for Patient Specific Education and Patient Electronic Access adopted under modified Stage 2 in the 2015 EHR Incentive Programs final rule (80 FR 62809 and 80 FR 62815), which do not include the word “electronic”. The word “electronic” was also not included in the certification specifications for the 2014 Edition, § 170.314(a)(15) (Patient-specific education resources) and § 170.314(e)(1) (View, download, and transmit to third party).

Provide Patient Access Measure: At least one patient seen by the MIPS eligible clinician during the performance period is provided timely access to view online, download, and transmit to a third party their health information subject to the MIPS eligible clinician's discretion to withhold certain information.

  • Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.
  • Numerator: The number of patients in the denominator (or patient authorized representative) who are provided timely access to health information to view online, download, and transmit to a third party.

View, Download, Transmit (VDT) Measure: At least one patient seen by the MIPS eligible clinician during the performance period (or patient-authorized representative) views, downloads or transmits their health information to a third party during the performance period.

  • Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.
  • Numerator: The number of unique patients (or their authorized representatives) in the denominator who have viewed online, downloaded, or transmitted to a third party the patient's health information during the performance period.

Objective: Patient-Specific Education.

Objective: The MIPS eligible clinician provides patients (or patient authorized representative) with timely electronic access to their health information and patient-specific education.

Proposed Change to the Objective: The MIPS eligible clinician uses clinically relevant information from CEHRT to identify patient-specific educational resources and provide those resources to the patient. We inadvertently finalized the description of the Patient Electronic Access objective for the Patient-Specific Education Objective, so that the Patient-Specific Education Objective had the wrong description. We are proposing to correct this error by adopting the description of the Patient-Specific Education Objective adopted under modified Stage 2 in the 2015 EHR Incentive Programs final rule (80 FR 62809 and 80 FR 62815). We are proposing this change would apply beginning with the performance period in 2017.

Patient-Specific Education Measure: The MIPS eligible clinician must use clinically relevant information from CEHRT to identify patient-specific educational resources and provide access to those materials to at least one unique patient seen by the MIPS eligible clinician.

  • Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.
  • Numerator: The number of patients in the denominator who were provided access to patient-specific educational resources using clinically relevant information identified from CEHRT during the performance period.

Objective: Secure Messaging.

Objective: Use CEHRT to engage with patients or their authorized representatives about the patient's care.

Secure Messaging Measure: For at least one patient seen by the MIPS eligible clinician during the performance period, a secure message was sent using the electronic messaging function of CEHRT to the patient (or the patient-authorized representative), or in response to a secure message sent by the patient (or the patient authorized representative) during the performance period.

  • Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.
  • Numerator: The number of patients in the denominator for whom a secure electronic message is sent to the patient (or patient-authorized representative) or in response to a secure message sent by the patient (or patient-authorized representative), during the performance period.

Objective: Health Information Exchange.

Objective: The MIPS eligible clinician provides a summary of care record when transitioning or referring their patient to another setting of care, receives or retrieves a summary of care record upon the receipt of a transition or referral or upon the first patient encounter with a new patient, and incorporates summary of care information from other health care clinicians into their EHR using the functions of CEHRT.

Proposed Change to the Objective: The MIPS eligible clinician provides a summary of care record when transitioning or referring their patient to another setting of care, receives or retrieves a summary of care record upon the receipt of a transition or referral or upon the first patient encounter with a new patient, and incorporates summary of care information from other health care providers into their EHR using the functions of CEHRT.

We inadvertently used the term “health care clinician” and are proposing to replace it with the more appropriate term “health care provider”. We are proposing this change would Start Printed Page 30073apply beginning with the performance period in 2017.

Health Information Exchange Measure: The MIPS eligible clinician that transitions or refers their patient to another setting of care or health care clinician (1) uses CEHRT to create a summary of care record; and (2) electronically transmits such summary to a receiving health care clinician for at least one transition of care or referral.

Proposed Change to the Measure: The MIPS eligible clinician that transitions or refers their patient to another setting of care or health care provider (1) uses CEHRT to create a summary of care record; and (2) electronically transmits such summary to a receiving health care provider for at least one transition of care or referral.

This change reflects the change proposed to the Health Information Exchange objective replacing “health care clinician” with “health care provider”. We are proposing this change would apply beginning with the performance period in 2017.

  • Denominator: Number of transitions of care and referrals during the performance period for which the EP was the transferring or referring health care clinician.

Proposed Change to the Denominator: Number of transitions of care and referrals during the performance period for which the MIPS eligible clinician was the transferring or referring health care provider. This change reflects the change proposed to the Health Information Exchange Measure replacing “health care clinician” with “health care provider”. We also inadvertently referred to the EP in the description and are replacing “EP” with “MIPS eligible clinician”. We are proposing this change would apply beginning with the performance period in 2017.

  • Numerator: The number of transitions of care and referrals in the denominator where a summary of care record was created using CEHRT and exchanged electronically.

Medication Reconciliation

Objective: Medication Reconciliation.

Proposed Objective: We are proposing to add a description of the Medication Reconciliation Objective beginning with the CY 2017 performance period, which we inadvertently omitted from the CY 2017 Quality Payment Program proposed and final rules, as follows:

Proposed Objective: The MIPS eligible clinician who receives a patient from another setting of care or provider of care or believes an encounter is relevant performs medication reconciliation. This description aligns with the objective adopted for Modified Stage 2 at 80 FR 62811.

Medication Reconciliation Measure: The MIPS eligible clinician performs medication reconciliation for at least one transition of care in which the patient is transitioned into the care of the MIPS eligible clinician.

  • Denominator: Number of transitions of care or referrals during the performance period for which the MIPS eligible clinician was the recipient of the transition or referral or has never before encountered the patient.
  • Numerator: The number of transitions of care or referrals in the denominator where the following three clinical information reconciliations were performed: Medication list, Medication allergy list, and current problem list.

Proposed Modification to the Numerator

Proposed Numerator: The number of transitions of care or referrals in the denominator where medication reconciliation was performed.

We are proposing to modify the numerator by removing medication list, medication allergy list, and current problem list. These three criteria were adopted for Stage 3 (80 FR 62862) but not for Modified Stage 2 (80 FR 62811). We are proposing this change would apply beginning with the performance period in 2017.

Objective: Public Health Reporting.

Objective: The MIPS eligible clinician is in active engagement with a public health agency or clinical data registry to submit electronic public health data in a meaningful way using CEHRT, except where prohibited, and in accordance with applicable law and practice.

Immunization Registry Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to submit immunization data.

Syndromic Surveillance Reporting Measure: The MIPS eligible clinician is in active engagement with a public health agency to submit syndromic surveillance data.

Specialized Registry Reporting Measure: The MIPS eligible clinician is in active engagement to submit data to a specialized registry.

We invite public comments on these proposals.

(c) Exclusions

We are proposing to add exclusions to the measures associated with the Health Information Exchange and Electronic Prescribing objectives required for the base score. We propose these exclusions would apply beginning with the CY 2017 performance period. In the CY 2017 Quality Payment Program final rule (81 FR 77237 through 77238), we did not finalize any exclusions for the measures specified for the advancing care information performance category as we believe that the MIPS exclusion criteria and that the advancing care information performance category scoring methodology together accomplish the same end as the previously established exclusions for the majority of the advancing care information performance category measures. We further noted that it was not necessary to finalize the proposed exclusion for the Immunization Registry Reporting Measure because MIPS eligible clinicians have the flexibility to choose whether to report the measure because it is part of the performance score of the advancing care information performance category. However, we understand that many MIPS eligible clinicians may not achieve a base score because they cannot fulfill the measures associated with the Health Information Exchange objective in the base score because they seldom refer or transition patients, and we believe that the implementation burden of the objective is too high to require of those with only a small number of referrals or transitions. Similarly, we understand that many MIPS eligible clinicians do not often write prescriptions in their practice or lack prescribing authority, and thus could not meet the E-prescribing Measure and would also fail to earn a base score. As this was not our intention, we are proposing to establish exclusions for these measures, as described below.

Proposed Exclusion for the E-Prescribing Objective and Measure: In the CY 2017 Quality Payment Program final rule (81 FR 28237 through 28238), we established a policy that MIPS eligible clinicians who write fewer than 100 permissible prescriptions in a performance period may elect to report their numerator and denominator (if they have at least one permissible prescription for the numerator), or they may report a null value. This policy has confused MIPS eligible clinicians as a null value would appear to indicate a MIPS eligible clinician has failed the measure and thus not would not achieve a base score. We are proposing to change this policy beginning with the CY 2017 performance period and propose to establish an exclusion for the e-Prescribing Measure. MIPS eligible clinicians who wish to claim this exclusion would select “yes” to the exclusion and submit a null value for the measure, thereby fulfilling the requirement to report this measure as Start Printed Page 30074part of the base score. It is important that a MIPS eligible clinician actually claims the exclusion if they wish to exclude the measure. If a MIPS eligible clinician does not claim the exclusion, they would fail the measure and not earn a base score or any score in the advancing care information performance category.

Advancing Care Information Objective and Measure.

Objective: Electronic Prescribing.

Objective: Generate and transmit permissible prescriptions electronically.

E-Prescribing Measure: At least one permissible prescription written by the MIPS eligible clinician is queried for a drug formulary and transmitted electronically using CEHRT.

  • Denominator: Number of prescriptions written for drugs requiring a prescription to be dispensed other than controlled substances during the performance period; or number of prescriptions written for drugs requiring a prescription to be dispensed during the performance period.
  • Numerator: The number of prescriptions in the denominator generated, queried for a drug formulary, and transmitted electronically using CEHRT.

Proposed Exclusion: Any MIPS eligible clinician who writes fewer than 100 permissible prescriptions during the performance period.

2017 and 2018 Advancing Care Information Transition Objective and Measure

Objective: Electronic Prescribing.

Objective: MIPS eligible clinicians must generate and transmit permissible prescriptions electronically.

E-Prescribing Measure: At least one permissible prescription written by the MIPS eligible clinician is queried for a drug formulary and transmitted electronically using CEHRT.

  • Denominator: Number of prescriptions written for drugs requiring a prescription to be dispensed other than controlled substances during the performance period; or number of prescriptions written for drugs requiring a prescription to be dispensed during the performance period.
  • Numerator: The number of prescriptions in the denominator generated, queried for a drug formulary, and transmitted electronically using CEHRT.

Proposed Exclusion: Any MIPS eligible clinician who writes fewer than 100 permissible prescriptions during the performance period.

Proposed Exclusion for the Health Information Exchange Objective and Measures: We are proposing to add exclusions for the measures associated with the Health Information Exchange Objective. Stakeholders have expressed concern through public comments on the CY 2017 Quality Payment Program proposed rule and other inquiries to us that some MIPS eligible clinicians are unable to meet the measures associated with the Health Information Exchange Objective, which are required for the base score, because they do not regularly refer or transition patients in the normal course of their practice. As we did not intend to disadvantage those MIPS eligible clinicians and prevent them from earning a base score, we are proposing the exclusions.

Advancing Care Information Objective and Measures

Objective: Health Information Exchange.

Objective: The MIPS eligible clinician provides a summary of care record when transitioning or referring their patient to another setting of care, receives or retrieves a summary of care record upon the receipt of a transition or referral or upon the first patient encounter with a new patient, and incorporates summary of care information from other health care clinician into their EHR using the functions of CEHRT.

We note that we proposed above to replace “health care clinician” with “health care provider”.

Send a Summary of Care Measure: For at least one transition of care or referral, the MIPS eligible clinician that transitions or refers their patient to another setting of care or health care clinician (1) creates a summary of care record using CEHRT; and (2) electronically exchanges the summary of care record.

We note that we proposed above to replace “health care clinician” with “health care provider”.

  • Denominator: Number of transitions of care and referrals during the performance period for which the MIPS eligible clinician was the transferring or referring clinician.
  • Numerator: The number of transitions of care and referrals in the denominator where a summary of care record was created using CEHRT and exchanged electronically.

Proposed Exclusion: Any MIPS eligible clinician who transfers a patient to another setting or refers a patient fewer than 100 times during the performance period.

Request/Accept Summary of Care Measure: For at least one transition of care or referral received or patient encounter in which the MIPS eligible clinician has never before encountered the patient, the MIPS eligible clinician receives or retrieves and incorporates into the patient's record an electronic summary of care document.

  • Denominator: Number of patient encounters during the performance period for which a MIPS eligible clinician was the receiving party of a transition or referral or has never before encountered the patient and for which an electronic summary of care record is available.
  • Numerator: Number of patient encounters in the denominator where an electronic summary of care record received is incorporated by the clinician into the CEHRT.

Proposed Exclusion: Any MIPS eligible clinician who receives transitions of care or referrals or has patient encounters in which the MIPS eligible clinician has never before encountered the patient fewer than 100 times during the performance period.

2017 and 2018 Advancing Care Information Transition Objective and Measures

Objective: Health Information Exchange.

Objective: The MIPS eligible clinician provides a summary of care record when transitioning or referring their patient to another setting of care, receives or retrieves a summary of care record upon the receipt of a transition or referral or upon the first patient encounter with a new patient, and incorporates summary of care information from other health care clinicians into their EHR using the functions of CEHRT.

We note that we are proposing above to replace “health care clinician” with “health care provider”.

Health Information Exchange Measure: The MIPS eligible clinician that transitions or refers their patient to another setting of care or health care clinician (1) uses CEHRT to create a summary of care record; and (2) electronically transmits such summary to a receiving health care clinician for at least one transition of care or referral.

We note that we are proposing above to replace “health care clinician” with “health care provider”.

  • Denominator: Number of transitions of care and referrals during the performance period for which the EP was the transferring or referring health care clinician.

We note that we are proposing above to replace “health care clinician” with “health care provider”.

  • Numerator: The number of transitions of care and referrals in the denominator where a summary of care Start Printed Page 30075record was created using CEHRT and exchanged electronically.

Proposed Exclusion: Any MIPS eligible clinician who transfers a patient to another setting or refers a patient fewer than 100 times during the performance period.

We are inviting public comment on these proposals.

(7) Additional Considerations

(a) 21st Century Cures Act

As we noted in the CY 2017 Quality Payment Program final rule (81 FR 77238), section 101(b)(1)(A) of the MACRA amended section 1848(a)(7)(A) of the Act to sunset the meaningful use payment adjustment at the end of CY 2018. Section 1848(a)(7) of the Act includes certain statutory exceptions to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act. Specifically, section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the application of the payment adjustment under section 1848(a)(7)(A) of the Act. In addition, section 1848(a)(7)(B) of the Act provides that the Secretary may, on a case-by-case basis, exempt an EP from the application of the payment adjustment under section 1848(a)(7)(A) of the Act if the Secretary determines, subject to annual renewal, that compliance with the requirement for being a meaningful EHR user would result in a significant hardship, such as in the case of an EP who practices in a rural area without sufficient internet access. The last sentence of section 1848(a)(7)(B) of the Act also provides that in no case may an exemption be granted under subparagraph (B) for more than 5 years. The MACRA did not maintain these statutory exceptions for the advancing care information performance category of the MIPS. Thus, we had previously stated that the provisions under sections 1848(a)(7)(B) and (D) of the Act are limited to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act and do not apply in the context of the MIPS.

Following the publication of the CY 2017 Quality Payment Program final rule, the 21st Century Cures Act (Pub. L. 114-255) was enacted on December 13, 2016. Section 4002(b)(1)(B) of the 21st Century Cures Act amended section 1848(o)(2)(D) of the Act to state that the provisions of sections 1848(a)(7)(B) and (D) of the Act shall apply to assessments of MIPS eligible clinicians under section 1848(q) of the Act with respect to the performance category described in subsection (q)(2)(A)(iv) (the advancing care information performance category) in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the meaningful use payment adjustment made under section 1848(a)(7)(A) of the Act. As a result of this legislative change, we believe that the general exceptions described under sections 1848(a)(7)(B) and (D) of the Act are applicable under the MIPS program. We include below proposals to implement these provisions as applied to assessments of MIPS eligible clinicians under section 1848(q) of the Act with respect to the advancing care information performance category.

(i) MIPS Eligible Clinicians Facing a Significant Hardship

In the CY 2017 Quality Payment Program final rule (81 FR 77240 through 77243), we recognized that there may not be sufficient measures applicable and available under the advancing care information performance category to MIPS eligible clinicians facing a significant hardship, such as those who lack sufficient internet connectivity, face extreme and uncontrollable circumstances, lack control over the availability of CEHRT, or do not have face-to-face interactions with patients. We relied on section 1848(q)(5)(F) of the Act to establish a final policy to assign a zero percent weighting to the advancing care information performance category in the final score if there are not sufficient measures and activities applicable and available to MIPS eligible clinicians within the categories of significant hardship noted above (81 FR 77243). Additionally, under the final policy (81 FR 77243), we did not impose a limitation on the total number of MIPS payment years for which the advancing care information performance category could be weighted at zero percent, in contrast with the 5-year limitation on significant hardship exceptions under the Medicare EHR Incentive Program as required by section 1848(a)(7)(B) of the Act.

We are not proposing substantive changes to this policy; however, as a result of the changes in the law made by the 21st Century Cures Act discussed above, we will not rely on section 1848(q)(5)(F) of the Act and instead are proposing to use the authority in the last sentence of section 1848(o)(2)(D) of the Act for significant hardship exceptions under the advancing care information performance category under MIPS. Section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, states in part that the provisions of section 1848(a)(7)(B) of the Act shall apply to assessments of MIPS eligible clinicians with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. We would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for a MIPS payment year for MIPS eligible clinicians who successfully demonstrate a significant hardship through the application process. We would use the same categories of significant hardship and application process as established in the CY 2017 Quality Payment Program final rule (81 FR 77240-77243). We would automatically reweight the advancing care information performance category to zero percent for a MIPS eligible clinician who lacks face-to-face patient interaction and is classified as a non-patient facing MIPS eligible clinician without requiring an application. If a MIPS eligible clinician submits an application for a significant hardship exception or is classified as a non-patient facing MIPS eligible clinician, but also reports on the measures specified for the advancing care information performance category, they would be scored on the advancing care information performance category like all other MIPS eligible clinicians, and the category would be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of the MIPS eligible clinician's score.

We believe this policy would be an appropriate application of the provisions of section 1848(a)(7)(B) of the Act to MIPS eligible clinicians and is similar to the manner in which those provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. Under the Medicare EHR Incentive Program an approved hardship exception exempted an EP from the payment adjustment. We believe that weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category.

As required under section 1848(a)(7)(B) of the Act, eligible professionals were not granted significant hardship exceptions for the payment adjustments under the Medicare EHR Incentive Program for more than 5 years. We propose not to apply the 5-year limitation under section 1848(a)(7)(B) of the Act to significant hardship exceptions for the advancing care information performance category under MIPS. We believe this proposal is an appropriate application of the provisions of section 1848(a)(7)(B) Start Printed Page 30076of the Act to MIPS eligible clinicians due to our desire to reduce clinician burden, promote the greatest level of participation in the MIPS program, and maintain consistency with the policies established in last year's final rule (81 FR 77243). In the Medicare EHR Incentive Program, we received many applications for significant hardship exceptions and approved most of them, which we believe indicates many eligible professionals were unable to or would have struggled to satisfy the requirements of meaningful use. We believe that there will be a continued need for significant hardship exceptions in order to provide clinicians with the necessary flexibility to participate in the MIPS program that best matches their available resources and circumstances, which may not change during a 5-year time period. For example, a clinician in an area without internet connectivity may continue to lack connectivity for more than 5 years. In addition, in the CY 2017 Quality Payment Program final rule (81 FR 77242 through 77243), we noted that we had received comments expressing appreciation that CMS moved away from the 5-year limitation to significant hardship exceptions.

We solicit comments on the proposed use of the authority provided in the 21st Century Cures Act in section 1848(o)(2)(D) of the Act as it relates to application of significant hardship exceptions under MIPS and the proposal not to apply a 5-year limit to such exceptions.

(ii) Significant Hardship Exception for MIPS Eligible Clinicians in Small Practices

Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to give consideration to the circumstances of small practices (consisting of 15 or fewer professionals) and practices located in rural areas and geographic HPSAs in establishing improvement activities under MIPS. In the CY 2017 Quality Payment Program final rule (81 FR 77187 through 77188), we finalized that for MIPS eligible clinicians and groups that are in small practices or located in rural areas, or geographic health professional shortage areas (HPSAs), to achieve full credit under the improvement activities category, one high-weighted or two medium-weighted improvement activities are required.

While there is no corresponding statutory provision for the advancing care information performance category, we believe that special consideration should also be available for MIPS eligible clinicians located in small practices. Through comments received on the CY 2017 Quality Payment Program proposed rule (81 FR 28161-28586), we heard many concerns about the impact of MIPS on eligible clinicians in small practices. Some commenters stated that there was not a meaningful exclusion for small practices that cannot afford the upfront investments (including investments in EHR technology) (81 FR 77066). Many noted there are still many small practices that have not adopted EHRs due to the administrative and financial burden. Some expressed concern that small group and solo practices would be driven out of business because of the potential negative payment adjustments under MIPS (81 FR 77055). A few commenters were concerned about the impact of MACRA on small practices and asked CMS to remain sensitive to this concern and offer special opportunities for MIPS eligible clinicians in areas threatened by access problems (81 FR 77055).

Based on these concerns, we are proposing a significant hardship exception for the advancing care information performance category for MIPS eligible clinicians who are in small practices, under the authority in section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act (see discussion of the statutory authority for significant hardship exceptions in section II.C.6.f.(7)(ii). We are proposing that this hardship exception would be available to MIPS eligible clinicians in small practices as defined under § 414.1305 (15 or fewer clinicians and solo practitioners). We are proposing in section II.C.1.e. of this proposed rule, that CMS would make eligibility determinations regarding the size of small practices for performance periods occurring in 2018 and future years. We are proposing to reweight the advancing care information performance category to zero percent of the MIPS final score for MIPS eligible clinicians who qualify for this hardship exception. We are proposing this exception would be available beginning with the 2018 performance period and 2020 MIPS payment year. We are proposing a MIPS eligible clinician seeking to qualify for this exception would submit an application in the form and manner specified by us by December 31st of the performance period or a later date specified by us. We are also proposing MIPS eligible clinicians seeking this exception must demonstrate in the application that there are overwhelming barriers that prevent the MIPS eligible clinician from complying with the requirements for the advancing care information performance category. In accordance with section 1848(a)(7)(B) of the Act, the exception would be subject to annual renewal. Under our proposal in section II.C.6.f.(7)(a), the 5-year limitation under section 1848(a)(7)(B) of the Act would not apply to this significant hardship exception for MIPS eligible clinicians in small practices.

We believe that applying the significant hardship exception in this way would be appropriate given the challenges small practices face as described by the commenters. In addition, we believe this application would be similar to the manner in which the exception applies with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act because weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category.

While we would be making this significant hardship exception available to small practices in particular, we are considering whether other categories or types of clinicians might similarly require an exception. We solicit comment on what those categories or types are, why such an exception is required, and any data available to support the necessity of the exception. We note that supporting data would be particularly helpful to our consideration of whether any additional exceptions would be appropriate.

We are seeking comments on these proposals.

(iii) Hospital-Based MIPS Eligible Clinicians

In the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77240), we defined a hospital-based MIPS eligible clinician under § 414.1305 as a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the Place of Service (POS) codes used in the HIPAA standard transaction as an inpatient hospital (POS 21), on-campus outpatient hospital (POS 22), or emergency room (POS 23) setting, based on claims for a period prior to the performance period as specified by CMS. We intend to use claims with dates of service between September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period, but in the event it is not operationally feasible to use claims from this time period, we will use a 12-month period as close as practicable to this time period. We discussed our assumption that MIPS eligible clinicians who are determined hospital-based do not have Start Printed Page 30077sufficient advancing care information measures applicable to them, and we established a policy to reweight the advancing care information performance category to zero percent of the MIPS final score for the MIPS payment year in accordance with section 1848(q)(5)(F) of the Act (81 FR 77240).

We are not proposing substantive changes to this policy; however, as a result of the changes in the law made by the 21st Century Cures Act discussed above, we will not rely on section 1848(q)(5)(F) of the Act and instead are proposing to use the authority in the last sentence of section 1848(o)(2)(D) of the Act for exceptions for hospital-based MIPS eligible clinicians under the advancing care information performance category. Section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, states in part that the provisions of section 1848(a)(7)(D) of the Act shall apply to assessments of MIPS eligible clinicians with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. We would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for a MIPS payment year for hospital-based MIPS eligible clinicians as previously defined. A hospital-based MIPS eligible clinician would have the option to report the advancing care information measures for the performance period for the MIPS payment year for which they are determined hospital-based. However, if a MIPS eligible clinician who is determined hospital-based chooses to report on the advancing care information measures, they would be scored on the advancing care information performance category like all other MIPS eligible clinicians, and the category would be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of their score.

We believe this policy would be an appropriate application of the provisions of section 1848(a)(7)(D) of the Act to MIPS eligible clinicians and is similar to the manner in which those provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. Under the Medicare EHR Incentive Program an approved hardship exception exempted an EP from the payment adjustment. We believe that weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category.

We propose to amend § 414.1380(c)(1) and (2) of the regulation text to reflect this proposal.

We request comments on the proposed use of the authority provided in the 21st Century Cures Act in section 1848(o)(2)(D) of the Act as it relates to hospital-based MIPS eligible clinicians.

(iv) Ambulatory Surgical Center (ASC)—Based MIPS Eligible Clinicians

Section 16003 of the 21st Century Cures Act amended section 1848(a)(7)(D) of the Act to provide that no payment adjustment may be made under section 1848(a)(7)(A) of the Act for 2017 and 2018 in the case of an eligible professional who furnishes substantially all of his or her covered professional services in an ambulatory surgical center (ASC). Section 1848(a)(7)(D)(iii) of the Act provides that determinations of whether an eligible professional is ASC-based may be made based on the site of service as defined by the Secretary or an attestation, but shall be made without regard to any employment or billing arrangement between the eligible professional and any other supplier or provider of services. Section 1848(a)(7)(D)(iv) of the Act provides that the ASC-based exception shall no longer apply as of the first year that begins more than 3 years after the date on which the Secretary determines, through notice and comment rulemaking, that CEHRT applicable to the ASC setting is available.

Under section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, the ASC-based provisions of section 1848(a)(7)(D) of the Act shall apply to assessments of MIPS eligible clinicians under section 1848(q) of the Act with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. We believe our proposals set forth below for ASC-based MIPS eligible clinicians are an appropriate application of the provisions of section 1848(a)(7)(D) of the Act to MIPS eligible clinicians. Under the Medicare EHR Incentive Program an approved hardship exception exempted an EP from the payment adjustment. We believe that weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category.

To align with our hospital-based MIPS eligible clinician policy, we are proposing to define at § 414.1305 an ASC-based MIPS eligible clinician as a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the Place of Service (POS) code 24 used in the HIPAA standard transaction based on claims for a period prior to the performance period as specified by us. We request comments on this proposal and solicit comments as to whether other POS codes should be used to identify a MIPS eligible clinician's ASC-based status or if an alternative methodology should be used. We note that the ASC-based determination will be made independent of the hospital-based determination.

To determine a MIPS eligible clinician's ASC-based status, we are proposing to use claims with dates of service between September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period, but in the event it is not operationally feasible to use claims from this time period, we would use a 12-month period as close as practicable to this time period. For example, for the 2018 performance period (2020 MIPS payment year), we would use the data available at the end of October 2017 for Medicare claims with dates of service between September 1, 2016 through August 31, 2017, to determine whether a MIPS eligible clinician is considered ASC-based under our proposed definition. We are proposing this timeline to allow us to notify MIPS eligible clinicians of their ASC-based status prior to the start of the performance period and to align with the hospital-based MIPS eligible clinician determination period. For the 2019 MIPS payment year, we would not be able to notify MIPS eligible clinicians of their ASC-based status until after the final rule is published, which we anticipate would be later in 2017. We expect that we would provide this notification through QPP.cms.gov.

For MIPS eligible clinicians who we determine are ASC-based, we propose to assign a zero percent weighting to the advancing care information performance category in the MIPS final score for the MIPS payment year. However, if a MIPS eligible clinician who is determined ASC-based chooses to report on the advancing care information measures for the performance period for the MIPS payment year for which they are determined ASC-based, we propose they would be scored on the advancing care information performance category like Start Printed Page 30078all other MIPS eligible clinicians, and the performance category would be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of their advancing care information performance category score.

We are proposing these ASC-based policies would apply beginning with the 2017 performance period/2019 MIPS payment year.

We propose to amend § 414.1380(c)(1) and (2) of the regulation text to reflect these proposals.

We request comments on these proposals.

(v) Exception for MIPS Eligible Clinicians Using Decertified EHR Technology

Section 4002(b)(1)(A) of the 21st Century Cures Act amended section 1848(a)(7)(B) of the Act to provide that the Secretary shall exempt an eligible professional from the application of the payment adjustment under section 1848(a)(7)(A) of the Act with respect to a year, subject to annual renewal, if the Secretary determines that compliance with the requirement for being a meaningful EHR user is not possible because the CEHRT used by such professional has been decertified under ONC's Health IT Certification Program. Section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, states in part that the provisions of section 1848(a)(7)(B) of the Act shall apply to assessments of MIPS eligible clinicians with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act.

We are proposing that a MIPS eligible clinician may demonstrate through an application process that reporting on the measures specified for the advancing care information performance category is not possible because the CEHRT used by the MIPS eligible clinician has been decertified under ONC's Health IT Certification Program. We are proposing that if the MIPS eligible clinician's demonstration is successful and an exception is granted, we would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for the MIPS payment year. In accordance with section 1848(a)(7)(B) of the Act, the exception would be subject to annual renewal, and in no case may a MIPS eligible clinician be granted an exception for more than 5 years. We are proposing this exception would be available beginning with the CY 2018 performance period and the 2020 MIPS payment year.

We are proposing that a MIPS eligible clinician may qualify for this exception if their CEHRT was decertified either during the performance period for the MIPS payment year or during the calendar year preceding the performance period for the MIPS payment year. We believe that this timeframe is appropriate because the loss of certification may prevent a MIPS eligible clinician from reporting for the advancing care information performance category because it will require that the MIPS eligible clinician switch to an alternate CEHRT, a process that we believe may take up to 2 years. For example, for the 2020 MIPS payment year, if the MIPS eligible clinician's EHR technology was decertified during the CY 2018 performance period or during CY 2017, the MIPS eligible clinician may qualify for this exception. In addition, we are proposing that the MIPS eligible clinician must demonstrate in their application and through supporting documentation if available that the MIPS eligible clinician made a good faith effort to adopt and implement another CEHRT in advance of the performance period. We are proposing a MIPS eligible clinician seeking to qualify for this exception would submit an application in the form and manner specified by us by December 31st of the performance period, or a later date specified by us.

We believe that applying the exception in this way is an appropriate application of the provisions of section 1848(a)(7)(B) of the Act to MIPS eligible clinicians given that weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category. Under the Medicare EHR Incentive Program an approved hardship exception exempted an EP from the payment adjustment. We believe that weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category.

The ONC Health IT Certification Program: Enhanced Oversight and Accountability final rule (“EOA final rule”) (81 FR 72404), effective December 19, 2016, created a regulatory framework for the ONC's direct review of health information technology (health IT) certified under the ONC Health IT Certification Program, including, when necessary, requiring the correction of non-conformities found in health IT certified under the Program and/or terminating certifications issued to certified health IT. Prior to the EOA final rule, ONC-Authorized Certification Bodies (ONC-ACBs) had the only authority to terminate or revoke certification of health IT under the program, which they used on previous occasions. On September 23, 2015, we posted an FAQ discussing the requirements for using a decertified CEHRT.[3]

Once all administrative processes, if any, are complete, then notice of a “termination of certification” is listed on the of the Certified Health IT Product List (CPHL) Web page.[4] As appropriate, ONC will also publicize the termination of certification of health IT through other communication channels (for example, ONC list serv(s)). Further, when ONC terminates the certification of a health IT product, the health IT developer is required to notify all potentially affected customers in a timely manner.

We further note that in comparison to termination actions taken by ONC and ONC-ACBs, a health IT developer may voluntarily withdraw a certification that is in good standing under the ONC Health IT Certification Program. A voluntary withdrawal may be the result of the health IT developer going out of business, the developer no longer supporting the product, or for other reasons that are not in response to ONC-ACB surveillance, ONC direct review, or a finding of non-conformity by ONC or an ONC-ACB.[5] In such instances, ONC will list these products on the “Inactive Certificates” [6] Web page of the CHPL.

We propose to amend § 414.1380(c)(1) and (2) of the regulation text to reflect these proposals. We are seeking comments on these proposals.

(b) Hospital-Based MIPS Eligible Clinicians

In the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77240, we defined a hospital-based MIPS eligible clinician as a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of services identified by the Place of Service (POS) codes used in the HIPAA standard transaction as an inpatient hospital (POS 21), on campus outpatient hospital Start Printed Page 30079(POS 22) or emergency room (POS 23) setting, based on claims for a period prior to the performance period as specified by CMS.

We are proposing to modify our policy to include covered professional services furnished by MIPS eligible clinicians in an off-campus-outpatient hospital (POS 19) in the definition of hospital-based MIPS eligible clinician. POS 19 was developed in 2015 in order to capture the numerous physicians that are paid for a portion of their services in an “off campus-outpatient hospital” versus an on campus-outpatient hospital, (POS 22). We also believe that these MIPS eligible clinicians would not typically have control of the development and maintenance of their EHR systems, just like those who bill using POS 22. We propose to add POS 19 to our existing definition of a hospital-based MIPS eligible clinician beginning with the performance period in 2018.

We invite comment on this proposal.

(c) Nurse Practitioners, Physician Assistants, Clinical Nurse Specialists, and Certified Registered Nurse Anesthetists

In the CY 2017 Quality Payment Program final rule (81 FR 77243-77244), we discussed our belief that certain types of MIPS eligible clinicians (NPs, PAs, CNSs, and CRNAs) may lack experience with the adoption and use of CEHRT. Because many of these non-physician clinicians are not eligible to participate in the Medicare or Medicaid EHR Incentive Program, we stated that we have little evidence as to whether there are sufficient measures applicable and available to these types of MIPS eligible clinicians under the advancing care information performance category. We established a policy under section 1848(q)(5)(F) of the Act to assign a weight of zero to the advancing care information performance category in the MIPS final score if there are not sufficient measures applicable and available to NPs, PAs, CRNAs, and CNSs. We will assign a weight of zero only in the event that an NP, PA, CRNA, or CNS does not submit any data for any of the measures specified for the advancing care information performance category. We encouraged all NPs, PAs, CRNAs, and CNSs to report on these measures to the extent they are applicable and available, however, we understand that some NPs, PAs, CRNAs, and CNSs may choose to accept a weight of zero for this performance category if they are unable to fully report the advancing care information measures. These MIPS eligible clinicians may choose to submit advancing care information measures should they determine that these measures are applicable and available to them; however, we noted that if they choose to report, they will be scored on the advancing care information performance category like all other MIPS eligible clinicians and the performance category will be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of their advancing care information performance category score.

We stated that this approach is appropriate for the first MIPS performance period based on the payment consequences associated with reporting, the fact that many of these types of MIPS eligible clinicians may lack experience with EHR use, and our current uncertainty as to whether we have adopted sufficient measures that are applicable and available to these types of MIPS eligible clinicians. We noted that we would use the first MIPS performance period to further evaluate the participation of these MIPS eligible clinicians in the advancing care information performance category and would consider for subsequent years whether the measures specified for this category are applicable and available to these MIPS eligible clinicians. At this time we have no additional information because the first MIPS performance period is currently underway, and thus we propose the same policy for NPs, PAs, CRNAs, and CNSs for the 2018 performance period as well. We still intend to evaluate the participation of these MIPS eligible clinicians in the advancing care information performance category for 2017 and expect to adopt measures applicable and available to them in subsequent years.

We are seeking comment on how the advancing care information performance category could be applied to NPs, PAs, CRNAs, and CNSs in future years of MIPS, and the types of measures that would be applicable and available to these types of MIPS eligible clinicians. In addition, through the Call for Measures Process we are seeking new measures that may be more broadly applicable to these additional types of MIPS eligible clinicians in future program years. For more information on the Call for Measures, see https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​MMS/​CallForMeasures.html.

We are inviting public comment on these proposals.

(d) Scoring for MIPS Eligible Clinicians in Group Practices

In any of the situations described in the sections above, we would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for the MIPS payment year if the MIPS eligible clinician meets certain specified requirements for this weighting. We noted that these MIPS eligible clinicians may choose to submit advancing care information measures; however, if they choose to report, they will be scored on the advancing care information performance category like all other MIPS eligible clinicians and the performance category will be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of their advancing care information performance category score. This policy includes MIPS eligible clinicians choosing to report as part of a group practice or part of a virtual group.

Group practices as defined at § 414.1310(e)(1) are required to aggregate their performance data across the TIN in order for their performance to be assessed as a group (81 FR 77058). Additionally, groups that elect to have their performance assessed as a group will be assessed as a group across all four MIPS performance categories. By reporting as part of a group practice, MIPS eligible clinicians are subscribing to the data reporting and scoring requirements of the group practice. We note that the data submission criteria for groups reporting advancing care information performance category described in the CY 2017 Quality Payment Program final rule (81 FR 77215) state that group data should be aggregated for all MIPS eligible clinicians within the group practice. This includes those MIPS eligible clinicians who may qualify for a zero percent weighting of the advancing care information performance category due to the circumstances as described above, such as a significant hardship or other type of exception, hospital-based or ASC-based status, or certain types of non-physician practitioners (NPs, PAs, CNSs, and CRNAs). If these MIPS eligible clinicians report as part of a group practice or virtual group, they will be scored on the advancing care information performance category like all other MIPS eligible clinicians and the performance category will be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of the group practice's advancing care information performance category score.Start Printed Page 30080

(e) Timeline for Submission of Reweighting Applications

In the CY 2017 Quality Payment Program final rule (81 FR77240-77243), we established the timeline for the submission of applications to reweight the advancing care information performance category in the MIPS final score to align with the data submission timeline for MIPS. We established that all applications for reweighting the advancing care information performance category be submitted by the MIPS eligible clinician or designated group representative in the form and manner specified by us. All applications may be submitted on a rolling basis, but must be received by us no later than the close of the submission period for the relevant performance period, or a later date specified by us. An application would need to be submitted annually to be considered for reweighting each year.

The Quality Payment Program Exception Application will be used to apply for the following exceptions: Insufficient Internet Connectivity; Extreme and Uncontrollable Circumstances; Lack of Control over the Availability of CEHRT; Decertification of CEHRT; and Small Practice.

We are proposing to change the submission deadline for the application as we believe that aligning the data submission deadline with the reweighting application deadline could disadvantages MIPS eligible clinicians. We are proposing to change the submission deadline for the CY 2017 performance period to December 31, 2017, or a later date specified by us. We believe this change would help MIPS eligible clinicians by allowing them to learn whether their application is approved prior to the data submission deadline for the CY 2017 performance period, March 31, 2018. We plan to have the application available in mid-2017. We encourage MIPS eligible clinicians to apply early as we expect to process the applications on a rolling basis. We note that if a MIPS eligible clinician submits data for the advancing care information category after an application has been submitted, the data would be scored, the application would be considered voided and the advancing care information performance category would not be reweighted.

We further propose that the submission deadline for the 2018 performance period will be December 31, 2018, or a later date as specified by us. We believe this would help MIPS eligible clinicians by allowing them to learn whether their application is approved prior to the data submission deadline for the CY 2018 performance period, March 31, 2019.

We request comments on these proposals.

g. APM Scoring Standard for MIPS Eligible Clinicians in MIPS APMs

(1) Overview

Under section 1848(q)(1)(C)(ii)(1) of the Act, Qualifying APM Participants (QPs) are not MIPS eligible clinicians and are thus excluded from MIPS reporting requirements and payment adjustments. Similarly, under section 1848(q)(1)(c)(ii)(II) of the Act, Partial Qualifying APM Participants (Partial QPs) are also not MIPS eligible clinicians unless they opt to report and be scored under MIPS. All other eligible clinicians, including those participating in MIPS APMs, are MIPS eligible clinicians and subject to MIPS reporting requirements and payment adjustments unless they are excluded on another basis such as being newly enrolled in Medicare or not exceeding the low volume threshold.

In the CY 2017 Quality Payment Program final rule (81 FR 77246-77269, 77543), we finalized the APM scoring standard, which is designed to reduce reporting burden for participants in certain APMs by minimizing the need for them to make duplicative data submissions for both MIPS and their respective APMs. We also sought to ensure that eligible clinicians in APM Entities that participate in certain types of APMs that assess their participants on quality and cost are assessed as consistently as possible across MIPS and their respective APMs. Given that many APMs already assess their participants on cost and quality of care and require engagement in certain improvement activities, we believe that without the APM scoring standard, misalignments could be quite common between the evaluation of performance under the terms of the APM and evaluation of performance on measures and activities under MIPS.

In the CY 2017 Quality Payment Program final rule (81 FR 77249), we identified the types of APMs for which the APM scoring standard would apply as MIPS APMs. We finalized that to be a MIPS APM, an APM must satisfy the following criteria: (1) APM Entities participate in the APM under an agreement with CMS or by law or regulation; (2) the APM requires that APM Entities include at least one MIPS eligible clinician on a Participation List; and (3) the APM bases payment incentives on performance (either at the APM Entity or eligible clinician level) on cost/utilization and quality measures. We specified that we will post the list of MIPS APMs prior to the first day of the MIPS performance year for each year (81 FR 77250). We finalized in the regulation at § 414.1370(b) that for a new APM to be a MIPS APM, its first performance year must start on or before the first day of the MIPS performance year. A list of MIPS APMs is available at www.qpp.cms.gov.

We established in the regulation at § 414.1370(c) that the MIPS performance year under § 414.1320 of the regulations applies for the APM scoring standard.

We finalized that under section § 414.1370(f) of our regulations on the APM scoring standard, MIPS eligible clinicians will be scored at the APM Entity group level and each eligible clinician will receive the APM Entity group's final score. The MIPS payment adjustment is applied at the TIN/NPI level for each of the MIPS eligible clinicians in the APM Entity. The MIPS final score is comprised of the four MIPS performance category scores, as described in our regulation at § 414.1370(g): quality, cost, improvement activities, and advancing care information. Both the Medicare Shared Savings Program and Next Generation ACO Model are MIPS APMs for the CY 2017 performance year. For these two MIPS APMs, in accordance with our regulation at § 414.1370(h), the MIPS performance category scores are weighted as follows: Quality at 50 percent; cost at zero percent; improvement activities at 20 percent; and advancing care information at 30 percent of the final score. For all other MIPS APMs for the CY 2017 performance year, quality and cost are each weighted at zero percent, improvement activities at 25 percent, and advancing care information at 75 percent of the final score.

As explained in the following sections, we propose to: Add an APM participant assessment date for full TIN APMs; add the CAHPS for ACOs survey to the Shared Savings Program and Next Generation ACO quality measures included for scoring under the MIPS APM quality performance category; define Other MIPS APMs; and add scoring for quality improvement to the MIPS APM quality performance category for MIPS APMs beginning in 2018. We also propose a Quality Payment Program 2018 performance year quality scoring methodology for Other MIPS APMs, and describe the scoring methodology for quality improvement for Other MIPS APMs as applicable.

In reviewing these proposals, we remind readers that the APM scoring Start Printed Page 30081standard is built upon the generally applicable MIPS scoring standard, but provides for special policies to address the unique circumstances of MIPS eligible clinicians who are in APM Entities participating in MIPS APMs. For the cost, improvement activities, and advancing care information performance categories, unless a separate policy has been established or is being proposed for the APM scoring standard, the generally applicable MIPS policies would be applicable. Additionally, unless we include a proposal to adopt a unique policy for the APM scoring standard, we propose to adopt the same generally applicable MIPS policies proposed elsewhere in this proposed rule, and would treat the APM Entity group as the group for purposes of MIPS. For the quality performance category, however, the APM scoring standard we propose is presented as a separate, unique standard, and therefore generally applicable MIPS policies would not be applied to the quality performance category under the APM scoring standard unless specifically stated. We seek comment on whether there may be potential conflicts or inconsistencies between the generally applicable MIPS policies and those under the APM scoring standard, particularly where these could impact our goals to reduce duplicative and potentially incongruous reporting requirements and performance evaluations that could undermine our ability to test or evaluate MIPS APMs, or whether certain generally applicable MIPS policies should be made explicitly applicable to the APM scoring standard.

(2) Assessment Dates for Inclusion of MIPS Eligible Clinicians in APM Entity Groups Under the APM Scoring Standard

In the CY 2017 Quality Payment Program final rule, we specified in the regulation at § 414.1370(e) that the APM Entity group for purposes of scoring under the APM scoring standard is determined in the manner prescribed at § 414.1425(b)(1), which provides that eligible clinicians who are on a Participation List on at least one of three dates (March 31, June 30, and August 31) would be considered part of the APM Entity group. Under these regulations, MIPS eligible clinicians who are not on a Participation List on one of these three assessment dates are not scored under the APM scoring standard. Instead, they would need to submit data to MIPS through one of the MIPS data submission mechanisms and their performance would be assessed either as individual MIPS eligible clinicians or as a group according to the generally applicable MIPS reporting and scoring criteria.

We will continue to use the three assessment dates of March 31, June 30, and August 31 to identify MIPS eligible clinicians who are on an APM Entity's Participation List and determine the APM Entity group that is used for purposes of the APM scoring standard. Beginning in the 2018 performance year, we propose to add a fourth assessment date of December 31 to identify those MIPS eligible clinicians who participate in a full TIN APM. We propose to define full TIN APM at § 414.1305 to mean an APM where participation is determined at the TIN level, and all eligible clinicians who have assigned their billing rights to a participating TIN are therefore participating in the APM. An example of a full TIN APM is the Shared Savings Program which requires all individuals and entities that have reassigned their right to receive Medicare payment to the TIN of an ACO participant to participate in the ACO and comply with the requirements of the Shared Savings Program.

If an eligible clinician elects to reassign their billing rights to a TIN participating in a full TIN APM, the eligible clinician is necessarily participating in the full TIN APM. We propose to add this fourth date of December 31 only for eligible clinicians in a full TIN APM, and only for purposes of applying the APM scoring standard. We are not proposing to use this additional assessment date of December 31 for purposes of QP determinations. Therefore, we propose to amend § 414.1370(e) to identify the four assessment dates that would be used to identify the APM Entity group for purposes of the APM scoring standard, and to specify that the December 31 date would be used only to identify eligible clinicians on the APM Entity's Participation List for a MIPS APM that is a full TIN APM in order to add them to the APM Entity group that is scored under the APM scoring standard.

We propose to use this fourth assessment date of December 31 to extend the APM scoring standard to only those MIPS eligible clinicians participating in MIPS APMs that are full TIN APMs, ensuring that an eligible clinician who joins the full TIN APM late in the performance year would be scored under the APM scoring standard. We considered proposing to use the fourth assessment date more broadly for all MIPS APMs. However, we believe that this approach would have allowed MIPS eligible clinicians to inappropriately leverage the fourth assessment date to avoid reporting and scoring under the generally applicable MIPS scoring standard when they were part of the MIPS APM for only a very limited portion of the performance year. That is, for MIPS APMs that allow split TIN participation, it would be possible for eligible clinicians to briefly join a MIPS APM principally in order to benefit from the APM scoring standard, despite having limited opportunity to contribute to the APM Entity's performance in the MIPS APM. In contrast, we believe MIPS eligible clinicians would be less likely to join a full TIN APM principally to avail themselves of the APM scoring standard, since doing so would require either that the entire TIN join the MIPS APM or the administratively burdensome act of the eligible clinician reassigning their billing rights to the TIN of an entity participating in the full TIN APM.

We will continue to use only the three dates of March 31, June 30, and August 31 to determine, based on Participation Lists, the MIPS eligible clinicians who participate in MIPS APMs that are not full TIN APMs. We seek comment on the proposed addition of the fourth date of December 31 to assess Participation Lists to identify MIPS eligible clinicians who participate in MIPS APMs that are full TIN APMs for purposes of the APM scoring standard.

(3) Calculating MIPS APM Performance Category Scores

In the CY 2017 Quality Payment Program final rule, we established a scoring standard for MIPS eligible clinicians participating in MIPS APMs to reduce participant reporting burden by reducing the need for eligible clinicians participating in these types of APMs to make duplicative data submissions for both MIPS and their respective APMs (81 FR 77246 through 77271). In accordance with section 1848(q)(1)(D)(i) of the Act, we proposed to assess the performance of a group of MIPS eligible clinicians in an APM Entity that participates in one or more MIPS APMs based on their collective performance as an APM Entity group, as defined at § 414.1305.

In addition to reducing reporting burden, we sought to ensure that eligible clinicians in MIPS APMs are not assessed in multiple ways on the same performance activities. Depending on the terms of the particular MIPS APM, we believe that misalignments could be common between the evaluation of performance on quality and cost under MIPS versus under the terms of the APM. We believe requiring eligible clinicians in MIPS APMs to submit data, be scored on measures, and be subject Start Printed Page 30082to payment adjustments that are not aligned between MIPS and an APM could potentially undermine the validity of testing or performance evaluation under the APM. We also believe imposition of MIPS reporting requirements would result in reporting activity that provides little or no added value to the assessment of eligible clinicians, and could confuse eligible clinicians as to which CMS incentives should take priority over others in designing and implementing care improvement activities.

(a) Cost Performance Category

In the CY 2017 Quality Payment Program final rule, for MIPS eligible clinicians participating in MIPS APMs, we used our authority to waive requirements under the Medicare statute to reduce the scoring weight for the cost performance category to zero (81 FR 77258, 77262, and 77266). We did this for MIPS APMs authorized under section 1115A of the Act using our authority under section 1115A(d)(1) of the Act to waive the requirement under section 1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for the cost performance category. Having reduced the cost performance category weight to zero, we further used our authority under section 1115A(d)(1) of the Act to waive the requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, cost measures in calculating the MIPS final score for MIPS eligible clinicians participating in Other MIPS APMs (81 FR 77261 through 77262 and 77265 through 77266). Similarly, for MIPS eligible clinicians participating in the Medicare Shared Savings Program, we used our authority under section 1899(f) of the Act to waive the same requirements of section 1848 of the Act for the MIPS cost performance category (81 FR 77257 through 77258). We finalized this policy because: (1) APM Entity groups are already subject to cost and utilization performance assessment under the MIPS APMs; (2) MIPS APMs usually measure cost in terms of total cost of care, which is a broader accountability standard that inherently encompasses the purpose of the claims-based measures that have relatively narrow clinical scopes, and MIPS APMs that do not measure cost in terms of total cost of care may depart entirely from MIPS measures; and (3) the beneficiary attribution methodologies differ for measuring cost under APMs and MIPS, leading to an unpredictable degree of overlap (for eligible clinicians and for CMS) between the sets of beneficiaries for which eligible clinicians would be responsible that would vary based on the unique APM Entity characteristics such as which and how many eligible clinicians comprise an APM Entity group. We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population, measurement of the population identified through the APM must take priority in order to ensure that the goals and the model evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across APMs and MIPS assessments may create uncertainty for MIPS eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of the APM. We are not proposing changes to these policies.

We welcome comment on our proposal to continue to waive the weighting of the cost performance category for the 2020 payment year forward.

(i) Measuring Improvement in the Cost Performance Category

In setting performance standards with respect to measures and activities in each MIPS performance category, section 1848(q)(3)(B) of the Act requires us to consider, historical performance standards, improvement, and the opportunity for continued improvement. Section 1848(q)(5)(D)(i)(I) requires us to introduce the measurement of improvement into performance scores in the cost performance category for MIPS eligible clinicians for the 2020 MIPS Payment Year if data sufficient to measure improvement are available. Section 1848(q)(5)(D)(i)(II) permits us to take into account improvement in the case of performance scores in other performance categories. Given that we have in effect waivers of the scoring weight for the cost performance category, and of the requirement to specify and use cost measures in calculating the MIPS final score for MIPS eligible clinicians participating in MIPS APMs, and for the same reasons that we initially waived those requirements, we propose 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 MIPS APMs under the Medicare Shared Savings Program, to waive the requirement under section 1848(q)(5)(D)(i)(I) of the Act to take improvement into account for performance scores in the cost performance category beginning with the 2018 MIPS performance year.

We seek comment on this proposal.

(b) Quality Performance Category

(i) Web Interface Reporters: Shared Savings Program and Next Generation ACO Model

(A) Quality Measures

We finalized in the CY 2017 Quality Payment Program final rule that under the APM scoring standard, participants in the Shared Savings Program and Next Generation ACO Model would be assessed for the purposes of generating a MIPS APM quality performance category score based exclusively on quality measures submitted using the CMS Web Interface (81 FR 77256 and 77261). In the CY 2017 Quality Payment Program final rule, we recognized that ACOs in both the Shared Savings Program and Next Generation ACO Model use the CMS Web Interface to submit data on quality measures, and that the measures they would report were also MIPS measures for 2017. For the Shared Savings Program and the Next Generation ACO Model, we finalized a policy to use quality measures and data submitted by the participant ACOs to the CMS Web Interface (as required under the rules for these initiatives) and MIPS benchmarks for these measures to score quality for MIPS eligible clinicians in these MIPS APMs at the APM Entity level (81 FR 77256, 77261). For these MIPS APMs, which we refer to as Web Interface reporters going forward, we established that quality performance data that are not submitted to the CMS Web Interface, for example the CAHPS for ACOs survey and claims-based measures, will not be included in the MIPS APM quality performance category score for 2017.

(aa) Addition of New Measures

For the Shared Savings Program and Next Generation ACO Model, we propose to score the CAHPS for ACOs survey, in addition to the CMS Web Interface measures that are used to calculate the MIPS APM quality performance category score for the Shared Savings Program and Next Generation ACO Model, beginning in the 2018 performance year. The CAHPS for ACOs survey is already required in the Shared Savings Program and Next Generation ACO Model, and including the CAHPS for ACOs survey would better align the measures on which participants in these MIPS APMs are assessed under the APM scoring standard with the measures used to Start Printed Page 30083assess participants' quality performance under the APM.

We did not initially propose to include the CAHPS for ACOs survey as part of the MIPS APM quality performance category scoring for the Shared Savings Program and Next Generation ACO Model because we believed that the CAHPS for ACOs survey would not be collected and scored in time to produce a MIPS quality performance category score. However, operational efficiencies have recently been introduced that have made it possible to score the CAHPS for ACOs survey on the same timeline as the CAHPS for MIPS survey. Under our proposal, the CAHPS for ACOs survey would be added to the total number of quality performance category measures available for scoring in these MIPS APMs.

While the CAHPS for ACOs survey is new to MIPS APM scoring, the CG-CAHPS survey upon which it is based is also the basis for the CAHPS for MIPS survey, which was included on the MIPS final list for the 2017 performance year. For a further discussion of the CAHPS for ACOs survey, and the way it will be scored, we refer readers to II.C.6.b.(3)(a)(ii) of this proposed rule, which describes the identical CAHPS for MIPS survey and its scoring method that will be used for MIPS in the 2018 performance year. We note that although each question in the CAHPS for ACOs survey can also be found in the CAHPS for MIPS survey, the CAHPS for ACOs survey will have one fewer survey question the SSM entitled “Between Visit Communication”, which has never been a scored measure with the Medicare Shared Savings Program CAHPS for ACOs Survey and which we believe to be inappropriate for use by ACOs.

Table 10—Web Interface Reporters: Shared Savings Program and Next Generation ACO Model New Measure

Measure nameNQF/quality number (if applicable)National quality strategy domainMeasure descriptionPrimary measure steward
CAHPS for ACOsN/APatient/Caregiver ExperienceConsumer Assessment of Healthcare Providers and Systems (CAHPS) surveys for Accountable Care Organizations (ACOs) in the Medicare Shared Savings Program (SSP) and Next Generation ACOs ask consumers about their experiences with health care. The CAHPS for ACOs Survey is collected from a sample of beneficiaries who get the majority of their care from an ACO, and the questions address care received from a named clinician within the ACOAgency for Healthcare Research and Quality (AHRQ)
Survey measures include:
—Getting Timely Care, Appointments, and Information
—How Well Your Providers Communicate
—Patients' Rating of Providers
—Access to Specialists
—Health Promotion and Education
—Shared Decision Making
—Health Status/Functional Status
—Stewardship of Patient Resources

(B) Calculating Quality Scores

We refer readers to section II.C.7.a.(1)(h)(ii) of this proposed rule for our summary of finalized policies and proposed changes related to calculating the MIPS quality performance category percent score for MIPS eligible clinicians, including APM Entity groups reporting through the CMS Web Interface. Those policies and proposed changes in section II.C.7.a.(1)(h)(ii) of this proposed rule would apply in the same manner under the APM scoring standard except as otherwise noted in this section of the proposed rule. However, we propose not to subject MIPS APM Web Interface reporters to a 3 point floor because we do not believe it is necessary to apply this transition year policy to eligible clinicians participating in previously established MIPS APMs.

(C) Incentives to Report High Priority Measures

In the CY 2017 Quality Payment Program final rule, we finalized that for CMS Web Interface reporters, we will apply bonus points based on the finalized set of measures reportable through the CMS Web Interface. (81 FR 77291 through 77294). We will assign two bonus points for reporting two or more outcome or patient experience measures and one bonus point for reporting any other high priority measure, beyond the first high priority measure. We note that in addition to the measures required by the APM to be submitted through the CMS Web Interface, APM Entities in the Shared Savings Program and Next Generation ACO Models must also report the CAHPS for ACOs survey and we propose that beginning for the 2020 payment year forward they may receive bonus points under the APM scoring standard for submitting that measure. Participants in MIPS APMs, like all MIPS eligible clinicians, are also subject to the 10 percent cap on bonus points for reporting high priority measures. APM Entities reporting through the CMS Web Interface will only receive bonus points if they submit a high priority measure with a performance rate that is greater than zero, provided that the measure meets the case minimum requirements.

(D) Scoring Quality Improvement

Beginning in the CY 2018 performance year, section 1848(q)(5)(D)(i)(I) of the Act requires us to score improvement for the MIPS quality performance category for MIPS eligible clinicians, including those participating in MIPS APMs, if data sufficient to measure quality improvement are available. We propose to calculate the quality improvement score using the methodology described in section II.C.7.a.(1)(i) for scoring quality improvement for eligible clinicians submitting quality measures via the CMS Web Interface. We believe aligning the scoring methodology used for all CMS Web Interface submissions will minimize confusion among MIPS eligible clinicians receiving a MIPS score, including those participating in MIPS APMs.

(E) Total Quality Performance Category Score for CMS Web Interface Reporters

We propose to calculate the total quality percent score for MIPS eligible clinicians using the CMS Web Interface according to the methodology described Start Printed Page 30084in section II.C.7.a.(1)(h)(2) of this proposed rule.

We seek comment on our proposed quality performance category scoring methodology for CMS Web Interface reporters.

(ii) Other MIPS APMs

We propose to define the term Other MIPS APM at § 414.1305 as a MIPS APM that does not require reporting through the CMS Web Interface. We propose to add this definition as we believe it will be useful in discussing our policies for the APM scoring standard. In the 2018 MIPS performance period, Other MIPS APMs will include the Comprehensive ESRD Care Model, the Comprehensive Primary Care Plus Model (CPC+), and the Oncology Care Model.

(A) Quality Measures

In the CY 2017 Quality Payment Program final rule, we explained that current MIPS APMs have requirements regarding the number of quality measures, measure specifications, as well as the measure reporting method(s) and frequency of reporting, and have an established mechanism for submission of these measures to us within the structure of the specific MIPS APM. We explained that operational considerations and constraints interfered with our ability to use the quality measure data from some MIPS APMs for the purpose of satisfying MIPS data submission requirements for the quality performance category for the first performance year. We concluded that there was insufficient time to adequately implement changes to the current MIPS APM quality measure data collection timelines and infrastructure in the first performance year to conduct a smooth hand-off to the MIPS system that would enable use of APM quality measure data to satisfy the MIPS quality performance category requirements in the first MIPS performance year (81 FR 77264). Out of concern that subjecting MIPS eligible clinicians who participate in MIPS APMs to multiple, potentially duplicative or inconsistent performance assessments could undermine the validity of testing or performance evaluation under the MIPS APMs; and that there was insufficient time to make adjustments in operationally complex systems and processes related to the alignment, submission and collection of APM quality measures for purposes of MIPS, we used our authority under section 1115A(d)(1) to waive certain requirements of section 1848(q).

We finalized that for the first MIPS performance year only, for MIPS eligible clinicians participating in APM Entities in Other MIPS APMs, the weight for the quality performance category is zero (81 FR 77268). To avoid risking adverse operational or program evaluation consequences for MIPS APMs while we worked toward incorporating MIPS APM quality measures into scoring for future performance years, we used the authority provided by section 1115A(d)(1) of the Act to waive the quality performance category weight required under section 1848(q)(5)(E)(i)(I) of the Act, and we indicated that with the reduction of the quality performance category weight to zero, it was unnecessary to establish for MIPS APMs a final list of quality measures as required under section 1848(q)(2)(D) of the Act or to specify and use quality measures in determining the MIPS final score for these MIPS eligible clinicians. As such, we further waived the requirements under sections 1848(q)(2)(D), 1848(q)(2)(B)(i) and 1848(q)(2)(A)(i) of the Act to establish a final list of quality measures (using certain criteria and processes); and to specify and use, respectively, quality measures in calculating the MIPS final score for the first MIPS performance year.

In the CY 2017 Quality Payment Program final rule, we anticipated that beginning with the second MIPS performance year, the APM quality measure data submitted to us during the MIPS performance year would be used to derive a MIPS quality performance score for APM Entities in all MIPS APMs.

We also anticipated that it may be necessary to propose policies and waivers of requirements of the statute, such as section 1848(q)(2)(D) of the Act, to enable the use of non-MIPS quality measures in the quality performance category score. We anticipated that by the second performance year we would have had sufficient time to resolve operational constraints related to use of separate quality measure systems and to adjust quality measure data submission timelines. Accordingly, we stated our intention to, in future rulemaking, use our section 1115A(d)(1) waiver authority to establish that the quality measures and data that are used to evaluate performance for APM Entities in MIPS APMs would be used to calculate a MIPS quality performance score under the APM scoring standard.

We have since designed the means to overcome the operational constraints that prevented us from scoring quality under the APM scoring standard in the first performance year, and we propose to adopt quality measures for use under the APM scoring standard, and begin collecting MIPS APM quality measure performance data in order to generate a MIPS quality performance category score for APM Entities participating in MIPS APMs beginning with the 2018 performance year.

(aa) APM Measures for MIPS

In the CY 2017 Quality Payment Program final rule, we explained the concerns that led us to express our intent to use the quality measures and data that apply in the MIPS APM for purposes of the APM scoring standard, including concerns about the application of multiple, potentially duplicative or inconsistent performance assessments that could negatively impact our ability to evaluate MIPS APMs (81 FR 77246). Additionally, the quality and cost/utilization measures that are used to calculate performance-based payments in MIPS APMs may vary from one MIPS APM to another. Factors such as the type and quantity of measures required, the MIPS APM's particular measure specifications, how frequently the measures must be reported, and the mechanisms used to collect or submit the measures all add to the diversity in the quality and cost/utilization measures used to evaluate performance among MIPS APMs. Given these concerns and the differences between and among the quality measures used to evaluate performance within MIPS APMs as opposed to those used more generally under MIPS, we propose to use our authority under section 1115A(d)(1) of the Act to waive requirements under section 1848(q)(2)(D) of the Act, which requires the Secretary to use certain criteria and processes to establish an annual MIPS final list of quality measures from which all MIPS eligible clinicians may choose measures for purposes of assessment, and instead to establish a MIPS APM quality measure list for purposes of the APM scoring standard. The MIPS APM quality measure list would be adopted as the final list of MIPS quality measures under the APM scoring standard, and would reflect the quality measures that are used to evaluate performance on quality within each MIPS APM.

The MIPS APM quality measure list we propose in Table 13, would define distinct measure sets for participants in each MIPS APM for purposes of the APM scoring standard, based on the measures that are used by the APM, and for which data will be collected by the close of the MIPS submission period. The measure sets on the MIPS APM measure list would represent all possible measures which may contribute to an APM Entity's MIPS score for the MIPS quality performance Start Printed Page 30085category, and may include measures that are the same as or similar to those used by MIPS. However, measures may ultimately not be used for scoring if a measure's data becomes inappropriate or unavailable for scoring; for example, if a measure's clinical guidelines are changed or the measure is otherwise modified by the APM during the performance year, the data collected during that performance year would not be uniform, and as such may be rendered unusable for purposes of the APM scoring standard (See Tables 14, 15, and 16).

(B) Measure Requirements for Other MIPS APMs

Because the quality measure sets for each Other MIPS APM are unique, we propose to calculate the MIPS quality performance category score using APM-specific quality measures. For purposes of the APM scoring standard, we will score only measures that: (1) Are tied to payment as described under the terms of the APM, (2) are available for scoring near the close of the MIPS submission period, (3) have a minimum of 20 cases available for reporting, and (4) have an available benchmark. We discuss each of these requirements for Other MIPS APM quality measures below.

(aa) Tied to Payment

For purposes of the APM scoring standard, we will consider a measure to be tied to payment if an APM Entity group will receive a payment adjustment or other incentive payment under the terms of the APM, based on the APM Entity's performance on the measure.

(bb) Available for Scoring

Some MIPS APM quality measure results are not available until late in the calendar year subsequent to the MIPS performance year, which would prevent us from including them in the MIPS APM quality performance category score due to the larger programmatic timelines for providing MIPS eligible clinician performance feedback by July and issuing budget-neutral MIPS payment adjustments. Consequently, we propose to only use the MIPS APM quality measure data that are submitted by the close of the MIPS submission period and are available for scoring in time for inclusion to calculate a MIPS quality performance category score. Measures are to be submitted according to requirements under the terms of the APM; the measure data will then be aggregated and prepared for submission to MIPS for the purpose of creating a MIPS quality performance category score.

We believe using the Other MIPS APMs' quality measure data that have been submitted no later than the close of the MIPS submission period and have been processed and made available to MIPS for scoring in time to calculate a MIPS quality performance category score is consistent with our intent to decrease duplicative reporting for MIPS eligible clinicians who would otherwise need to report quality measures to both MIPS and their APM. Going forward, these are the measures to which we are referring when we limit scoring to measures that are available near the close of the MIPS submission period.

(cc) 20 Case Minimum

We also believe that a 20 case minimum, in alignment with the one finalized generally under MIPS in the CY 2017 Quality Payment Program final rule (81 FR 77288), is necessary to ensure the reliability of the measure data submitted, as explained the CY 2017 Quality Payment Program final rule.

As under the general policy for MIPS, when an APM Entity reports a quality measure that includes less than 20 cases, that measure would receive a null score for that measure's achievement points, and the measure would be removed from both the numerator and the denominator of the MIPS quality performance category percentage. We propose to apply this policy under the APM scoring standard.

(dd) Available Benchmark

An APM Entity's score on each quality measure would be calculated in part by comparing the APM Entity's performance on the measure with a benchmark performance score. Therefore, we would need all scored measures to have a benchmark available by the time that the MIPS quality performance category score is calculated, in order to make that comparison.

We propose that, for the APM scoring standard, the benchmark score used for a quality measure would be the benchmark used in the MIPS APM for calculation of the performance based payments, where such a benchmark is available. If the APM does not produce a benchmark score for a reportable measure that is included on the APM measures list, we would use the benchmark score for the measure that is used for the MIPS quality performance category generally (outside of the APM scoring standard) for that performance year, provided the measure specifications for the measure are the same under both the MIPS final list and the APM measures list. If neither the APM nor MIPS has a benchmark available for a reported measure, the APM Entity that reported that measure would receive a null score for that measure's achievement points, and the measure would be removed from both the numerator and the denominator of the quality performance category percentage.

(C) Calculating the Quality Performance Category Percent Score

Eligible clinicians who participate in Other MIPS APMs are subject to specific quality measure reporting requirements within these APMs. To best align with APM design and objectives, we propose that the minimum number of required measures to be reported for the APM scoring standard would be the minimum number of quality measures that are required by the MIPS APM and are collected and available in time to be included in the calculation for the APM Entity score under the APM scoring standard. For example, if an Other MIPS APM requires participating APM Entities to report nine of 14 quality measures by a specific date and the APM Entity misses the MIPS submission deadline, then for the purposes of calculating an APM Entity quality performance category score, the APM Entity would receive a zero for those measures. An APM Entity that does not submit any APM quality measures by the MIPS submission deadline would receive a zero for its MIPS APM quality performance category percent score for the performance year.

We propose that if an APM Entity submits some, but not all of the measures required by the MIPS APM by the close of the MIPS submission period, the APM Entity would receive points for the measures that were submitted, but would receive a score of zero for each remaining measure between the number of measures reported and the number of measures required by the APM that were available for scoring.

For example, if an APM Entity in the above hypothetical MIPS APM submits quality performance data on three of the APM's measures, instead of the required nine, the APM Entity would receive quality points in the APM scoring standard quality performance category percent score for the three measures it submitted, but would receive zero points for each of the six remaining measures that were required under the terms of the MIPS APM. On the other hand, if an APM Entity reports on more than the minimum number of measures required to be reported under the MIPS APM and the measures meet the other Start Printed Page 30086criteria for scoring, only the measures with the highest scores, up to the number of measures required to be reported under the MIPS APM, would be counted; however, any bonus points earned by reporting on measures beyond the minimum number of required measures would be awarded.

If a measure is reported but fails to meet the 20 case minimum or does not have a benchmark available, there would be a null score for that measure, and it would be removed from both the numerator and the denominator, so as not to negatively affect the APM Entity's quality performance category score.

We propose to assign bonus points for reporting high priority measures or measures with end-to-end CEHRT reporting as described for general MIPS scoring in the CY 2017 Quality Payment Program final rule (81 FR 77297 through 77299).

(aa) Quality Measure Benchmarks

An APM Entity's MIPS quality measure score will be calculated by comparing the APM Entity's performance on a given measure with a benchmark performance score. We propose that the benchmark score used for a quality measure would be the benchmark used by the MIPS APM for calculation of the performance based payments within the APM, if possible, in order to best align the measure performance outcomes between the APM and MIPS programs. If the MIPS APM does not produce a benchmark score for a reportable measure that will be available at the close of the MIPS submission period, the benchmark score for the measure that is used for the MIPS quality performance category generally for that performance year would be used, provided the measure specifications are the same for both. If neither the APM nor MIPS has a benchmark available for a reported measure, the APM Entity that reported that measure will receive a null score for that measure's achievement points, and the measure will be removed from both the numerator and the denominator of the quality performance category percentage.

We are proposing that for measures that are pay for reporting or which do not measure performance on a continuum of performance, we will consider these measures to be lacking a benchmark and they will be treated as such. For example, if a model only requires that an APM Entity must surpass a threshold and does not measure APM Entities on performance beyond surpassing a threshold, we would not consider such a measure to measure performance on a continuum.

We propose to score quality measure performance under the APM scoring standard using a percentile distribution, separated by decile categories, as described in the finalized MIPS quality scoring methodology (81 FR 77282 through 77284). For each benchmark, we will calculate the decile breaks for measure performance and assign points based on the benchmark decile range into which the APM Entity's measure performance falls.

We propose to use a graduated points-assignment approach, where a measure is assigned a continuum of points out to one decimal place, based on its place in the decile. For example, a raw score of 55 percent would fall within the sixth decile of 41.0 percent to 61.9 percent and would receive between 6.0 and 6.9 points.

We seek comment on this proposed method.

Table 11—Benchmark Decile Distribution

Sample benchmark decileSample quality measure (%)Graduated points (with no floor)
Example Benchmark Decile 10-9.91.0-1.9
Example Benchmark Decile 210.0-17.92.0-2.9
Example Benchmark Decile 318.0-22.93.0-3.9
Example Benchmark Decile 423.0-35.94.0-4.9
Example Benchmark Decile 536.0-40.95.0-5.9
Example Benchmark Decile 641.0-61.96.0-6.9
Example Benchmark Decile 762.0-68.97.0-7.9
Example Benchmark Decile 869.0-78.98.0-8.9
Example Benchmark Decile 979.0-84.99.0-9.9
Example Benchmark Decile 1085.0-10010.0

(bb) Assigning Quality Measure Points Based on Achievement

For the APM scoring standard quality performance category, we propose that each APM Entity that reports on quality measures would receive between 1 and 10 achievement points for each measure reported that can be reliably scored against a benchmark, up to the number of measures that are required to be reported by the APM. Because measures that lack benchmarks or 20 reported cases are removed from the numerator and denominator of the quality performance category percentage, it is unnecessary to include a point-floor for scoring of Other MIPS APMs. Similarly, because the quality measures reported by the MIPS APM for MIPS eligible clinicians under the APM scoring standard are required to be submitted to the APM under the terms of participation in the APM, and the MIPS eligible clinicians do not select their APM measures, there will be no cap on topped out measures for MIPS APM participants being scored under the APM scoring standard, which differs from the policy for other MIPS eligible clinicians proposed at section II.C.7.a.(2)(c) of this proposed rule.

Beginning in the 2018 MIPS performance year, we propose that APM Entities in MIPS APMs, like other MIPS eligible clinicians, would be eligible to receive bonus points for the MIPS quality performance category for reporting on high priority measures or measures submitted via CEHRT (for example, end-to-end submission) according to the criteria described in section II.C.7.a.(1) of this proposed rule. For each Other MIPS APM, we propose to identify whether any of their available measures meets the criteria to receive a bonus, and add the bonus points to the quality achievement points. Further, we propose that the total number of awarded bonus points may not exceed 10 percent of the APM Entity's total available achievement points for the MIPS quality performance category score.

To generate the APM Entity's quality performance category percentage, achievement points would be added to any applicable bonus points, and then divided by the total number of available achievement points, with a cap of 100 Start Printed Page 30087percent. For more detail on the MIPS quality performance category percentage score calculation, we refer readers to section II.C.7.a.(1) of this proposed rule.

Under the APM scoring standard for Other MIPS APMs, the number of available achievement points would be the number of measures required under the terms of the APM and available for scoring multiplied by ten. If, however, an APM Entity reports on a required measure that fails the 20 case minimum requirement, or which has no available benchmark for that performance year, the measure would receive a null score and all points from that measure would be removed from both the numerator and the denominator.

For example, if an APM Entity reports on four out of four measures required to be reported by the MIPS APM, and receives an achievement score of five on each and no bonus points, the APM Entity's quality performance category percentage would be [(5 points × 4 measures) + 0 bonus points]/(4 measures × 10 max available points), or 50 percent. If, however, one of those measures failed the 20 case minimum requirement or had no benchmark available, that measure would have a null value and would be removed from both the numerator and denominator to create a quality performance category percentage of [(5 points × 3 measures) + 0 bonus points]/(3measures × 10 max available points), or 50 percent.

If an APM Entity fails to meet the 20 case minimum on all available APM measures, that APM Entity would have its quality performance category score reweighted to zero, as described below.

We request comment on the above proposals for calculating the quality category percent score.

(D) Quality Improvement Scoring

Beginning in the 2018 performance year, we propose to score improvement as well as achievement in the quality performance category.

For the APM scoring standard, we propose that the quality improvement percentage points would be awarded based on the following formula:

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

For a more detailed discussion of improvement scoring for the quality performance category under the APM scoring standard, we refer readers to the discussion on calculating improvement at the quality performance category level for MIPS at section II.C.7.a.(1)(i) of this proposed rule.

(E) Calculating Total Quality Performance Category Score

We propose that the APM Entity's total quality performance category score would be equal to [(achievement points + bonus points)/total available achievement points] + quality improvement score. The APM Entity's total quality performance category score may not exceed 100 percent. We request comment on the above proposed quality scoring methodology.

We seek comment on the proposed quality performance category scoring methodology for APM Entities participating in Other MIPS APMs.

(c) Improvement Activities Performance Category

As finalized in the CY 2017 Quality Payment Program final rule, for all MIPS APMs we will assign the same improvement activities score to each APM Entity based on the activities involved in participation in a MIPS APM. APM Entities will receive a minimum of one half of the total possible points. This policy is in accordance with section 1848(q)(5)(C)(ii) of the Act. In the event that the assigned score does not represent the maximum improvement activities score, the APM Entity group will have the opportunity to report additional improvement activities to add points to the APM Entity level score.

(d) Advancing Care Information Performance Category

In the CY 2017 Quality Payment Program final rule, we finalized our policy to attribute one score to each MIPS eligible clinician in an APM Entity group by looking for both individual and group TIN level data submitted for a MIPS eligible clinician, and using the highest available score (81 FR 77268). We will then use these scores to create an APM Entity's score based on the average of the highest scores available for all MIPS eligible clinicians in the APM Entity group. If an individual or TIN did not report on the advancing care information performance category, they will contribute a zero to the APM Entity's aggregate score. Each MIPS eligible clinician in an APM Entity group will receive one score, weighted equally with the scores of every other MIPS eligible clinician in the APM Entity group, and we will use these to calculate a single APM Entity-level advancing care information performance category score.

We refer readers to section II.C.6.f.(6) of this proposed rule for our summary of proposed changes related to scoring the advancing care information performance category.

(i) Special Circumstances

As described in the CY 2017 Quality Payment Program final rule (81 FR 77238-77245), under the generally applicable MIPS scoring standard, we will assign a weight of zero percent to the advancing care information performance category in the final score for MIPS eligible clinicians who meet specific criteria: hospital-based MIPS eligible clinicians, MIPS eligible clinicians who are facing a significant hardship, and certain types of non-physician practitioners (NPs, PAs, CRNAs, CNSs) who are MIPS eligible clinicians. In section II.C.7.a.(6) of this proposed rule, we are also proposing to include in this weighting policy ASC-based MIPS eligible clinicians and MIPS eligible clinicians who are using decertified EHR technology.

Under the APM scoring standard, we propose that if a MIPS eligible clinician who qualifies for a zero percent weighting of the advancing care information performance category in the final score is part of a TIN that includes one or more MIPS eligible clinicians who do not qualify for a zero percent weighting, we would not apply the zero percent weighting to the qualifying MIPS eligible clinician, and the TIN would still be required to report on behalf of the group, although the TIN would not need to report data for the qualifying MIPS eligible clinician. All MIPS eligible clinicians in the TIN would count towards the TIN's weight when calculating an aggregated APM Entity score for the advancing care information performance category.

If, however, the MIPS eligible clinician is a solo practitioner and qualifies for a zero percent weighting, or if all MIPS eligible clinicians in a TIN qualify for the zero percent weighting, the TIN would not be required to report on the advancing care information performance category, and if the TIN chooses not to report that TIN would be assigned a weight of 0 when calculating the APM Entity's advancing care information performance category score.

If advancing care information data are reported by one or more TINs in an APM Entity, an advancing care information performance category score will be calculated for, and will be applicable to, all MIPS eligible clinicians in the APM Entity group. If all MIPS eligible clinicians in all TINs in an APM Entity group qualify for a zero percent weighting of have the advancing care information performance category, or in the case of a solo practitioner who comprises an entire Start Printed Page 30088APM Entity and qualifies for zero percent weighting, the advancing care information performance category would be weighted at zero percent of the final score, and the advancing care information performance category's weight would be redistributed to the quality performance category.

(4) Calculating Total APM Entity Score

(a) Performance Category Weighting

As discussed in section II.C.6.g.(3)(a) of this proposed rule, we propose to continue to use our authority to waive sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, cost measures; and to maintain the cost performance category weight of zero under the APM scoring standard for the 2018 performance period and subsequent MIPS performance periods. Because the cost performance category would be reweighted to zero that weight would need to be redistributed to other performance categories. We propose to use our authority under section 1115A(d)(1) to waive requirements under sections 1848(q)(5)(E)(i)(I)(bb), 1848(q)(5)(E)(i)(III) and 1848(q)(5)(E)(i)(IV) of the Act that prescribe the weights, respectively, for the quality, improvement activities, and ACI performance categories. We propose to weight the quality performance category score to 50 percent, the improvement activities performance category to 20 percent, and the advancing care information performance category to 30 percent of the final score for all APM Entities in Other MIPS APMs. We propose these weights to align the Other MIPS APM performance category weights with those assigned to the Web Interface reporters, which we adopted as explained in the CY 2017 Quality Payment Program final rule at 81 FR 77262 through 77263. We believe it is appropriate to align the performance category weights for APM Entities in MIPS APMs that require reporting through the Web Interface with those in Other MIPS APMs. By aligning the performance category weights among all MIPS APMs, we would create greater scoring parity among the MIPS eligible clinicians in MIPS APMs who are being scored under the APM scoring standard. These proposals are summarized in Table 12.

Table 12—APM Scoring Standard Performance Category Weights—Beginning for the 2018 Performance Period

MIPS performance categoryAPM entity submission requirementPerformance category scorePerformance category weight (%)
QualityThe APM Entity will be required to submit quality measures to CMS as required by the MIPS APM. Measures available at the close of the MIPS submission period will be used to calculate the MIPS quality performance category score. If the APM Entity does not submit any APM required measures by the MIPS submission deadline, the APM Entity will be assigned a zeroCMS will assign the same quality category performance score to each TIN/NPI in an APM Entity group based on the APM Entity's total quality score, derived from available APM quality measures50
CostThe APM Entity group will not be assessed on cost under MIPSN/A0
Improvement ActivitiesMIPS eligible clinicians do not need to report improvement activities data; if the CMS-assigned improvement activities score is below the maximum improvement activities score APM Entities will have the opportunity to submit additional improvement activities to raise the APM Entity improvement activity scoreCMS will assign the same improvement activities score to each APM Entity based on the activities involved in participation in the MIPS APM. APM Entities will receive a minimum of one half of the total possible points. In the event that the assigned score does not represent the maximum improvement activities score, the APM Entity will have the opportunity to report additional improvement activities to add points to the APM Entity level score20
Advancing Care InformationEach MIPS eligible clinician in the APM Entity group is required to report advancing care information to MIPS through either group TIN or individual reportingWe will attribute the same score to each MIPS eligible clinician in the APM Entity group. This score will be the highest score attributable to the TIN/NPI combination of each MIPS eligible clinician, which may be derived from either group or individual reporting. The scores attributed to each MIPS eligible clinicians will be averaged for a single APM Entity score30

It is possible that there could be instances where an Other MIPS APM has no measures available to score for the quality performance category for a MIPS performance period; for example, it is possible that none of the Other MIPS APM's measures would be available for calculating a quality performance category score by or shortly after the close of the MIPS submission period because the measures were removed due to changes in clinical practice guidelines. In addition, as explained in section II.C.6.g.(3)(d)(i) of this proposed rule, the MIPS eligible clinicians in an APM Entity may qualify for a zero percent weighting for the advancing care information performance category. In such instances, under the APM scoring standard, we propose to reweight the affected performance category to zero, in accordance with section 1848(q)(5)(F) of the Act.

If the quality performance category is reweighted to zero, we propose to reweight the improvement activities and advancing care information performance categories to 25 and 75 percent, respectively. If the advancing care information performance category is reweighted to zero, the quality performance category weight would be Start Printed Page 30089increased to 80 percent. These proposals are summarized in Table 13.

Table 13—APM Scoring Standard Performance Category Weights for Other MIPS APMs With Performance Categories Weighted to 0—Beginning for the 2018 Performance Period

MIPS performance categoryAPM entity submission requirementPerformance category scorePerformance category weight (no quality) (%)Performance category weight (no advancing care information) (%)
QualityThe APM Entity would not be assessed on quality under MIPS if no quality data are available at the close of the MIPS submission period. The APM Entity will submit quality measures to CMS as required by the MIPS APMCMS will assign the same quality category performance score to each TIN/NPI in an APM Entity group based on the APM Entity's total quality score, derived from available APM quality measures080
CostThe APM Entity group will not be assessed on cost under MIPSN/A00
Improvement ActivitiesMIPS eligible clinicians do not need to report improvement activities data unless the CMS-assigned improvement activities scores is below the maximum improvement activities scoreCMS will assign the same improvement activities score to each APM Entity group based on the activities involved in participation in the MIPS APM APM Entities will receive a minimum of one half of the total possible points. In the event that the assigned score does not represent the maximum improvement activities score, the APM Entity will have the opportunity to report additional improvement activities to add points to the APM Entity level score2520
Advancing Care InformationEach MIPS eligible clinician in the APM Entity group reports advancing care information to MIPS through either group TIN or individual reportingWe will attribute the same score to each MIPS eligible clinician in the APM Entity group. This score will be the highest score attributable to the TIN/NPI combination of each MIPS eligible clinician, which may be derived from either group or individual reporting. The scores attributed to each MIPS eligible clinicians will be averaged for a single APM Entity score750

We seek comment on the proposed reweighting for APM Entities participating in MIPS APMs.

(b) Risk Factor Score

Section 1848(q)(1)(G) of the Act requires us to consider risk factors in our scoring methodology. Specifically, that section provides that the Secretary, on an ongoing basis, shall, as the Secretary determines appropriate and based on individuals' health status and other risk factors, assess appropriate adjustments to quality measures, cost measures, and other measures used under MIPS and assess and implement appropriate adjustments to payment adjustments, final scores, scores for performance categories, or scores for measures or activities under the MIPS.

We refer readers to II.C.7.b.(1) of this proposed rule for a description of the risk factor adjustment and its application to APM Entities.

(c) Small Practice Bonus

We believe an adjustment for eligible clinicians in small practices (referred to herein as the small practice bonus) is appropriate to recognize barriers faced by small practices, such as unique challenges related to financial and other resources, environmental factors, and access to health information technology, and to incentivize eligible clinicians in small practices to participate in the Quality Payment Program and to overcome any performance discrepancy due to practice size.

We refer readers to section II.C.7.b.(2) of this proposed rule for a discussion of the small practice adjustment and its application to APM Entities.

(d) Final Score Methodology

In the CY 2017 Quality Payment Program final rule, we finalized the methodology for calculating a final score of 0-100 based on the four performance categories (81 FR 77320). We refer readers to section II.C.7.c. of this proposed rule for a discussion of the changes we are proposing for the final score methodology.

(5) MIPS APM Performance Feedback

In the CY 2017 Quality Payment Program final rule (81 FR 77270), we finalized that all MIPS eligible clinicians scored under the APM scoring standard will receive performance feedback as specified under section 1848(q)(12) of the Act on the quality and cost performance categories to the extent applicable, based on data collected in the September 2016 QRUR, unless they did not have data included in the September 2016 QRUR. Those eligible clinicians without data included in the September 2016 QRUR will not receive any performance feedback until performance data is available for feedback.

Beginning with the 2018 performance year, we propose that MIPS eligible clinicians whose MIPS payment adjustment is based on their score under the APM scoring standard will receive performance feedback as specified Start Printed Page 30090under section 1848(q)(12) of the Act for the quality, advancing care information, and improvement activities performance categories to the extent data are available for the MIPS performance year. Further, we propose that in cases where performance data are not available for a MIPS APM performance category because the MIPS APM performance category has been weighted to zero for that performance year, we would not provide performance feedback on that MIPS performance category.

We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population, the incentives of the APM must take priority over those offered by MIPS in order to ensure that the goals and evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting messages in performance feedback provided by the APMs and that provided by MIPS may create uncertainty for MIPS eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of the APM. Accordingly, under section 1115A(d)(1) and section 1899(f), for all performance years we propose to waive—for MIPS eligible clinicians participating in MIPS APMs—the requirement under section 1848(q)(12)(A)(i)(I) of the Act to provide performance feedback for the cost performance category.

We request comment on these proposals to waive requirements for performance feedback on the cost performance category indefinitely, and for the other performance categories in years for which the weight for those categories has been reweighted to zero.

(6) Summary of Proposals

In summary, we have proposed the following in this section:

  • We propose to amend the regulation at § 414.1370(e) to identify the four assessment dates that would be used to identify the APM Entity group for purposes of the APM scoring standard, and to specify that the December 31 date will be used only to identify eligible clinicians on the APM Entity's Participation List for a MIPS APM that is a full TIN APM in order to add them to the APM Entity group that is scored under the APM scoring standard. We propose to use this fourth assessment date of December 31 to extend the APM scoring standard to only those MIPS eligible clinicians participating in MIPS APMs that are full TIN APMs, ensuring that an eligible clinician who joins the full TIN APM late in the performance year would be scored under the APM scoring standard.
  • We propose to continue to weight the cost performance category under the APM scoring standard for Web Interface reporters at zero percent for the 2020 payment year forward.
  • Aligned with our proposal to weight the cost performance category at zero percent, we propose not to take improvement into account for performance scores in the cost performance category for Web Interface reporters beginning with the 2020 MIPS Payment Year.
  • We propose to score the CAHPS for ACOs survey, in addition to the CMS Web Interface measures that are used to calculate the MIPS APM quality performance category score for Web Interface reporters including the Shared Savings Program and Next Generation ACO Model), beginning in the 2018 performance year.
  • We propose that, beginning for the 2018 performance year, eligible clinicians in MIPS APMs that are Web Interface reporters may receive bonus points under the APM scoring standard for submitting the CAHPS for ACOs survey.
  • We propose to calculate the quality improvement score for MIPS eligible clinicians submitting quality measures via the CMS Web Interface using the methodology described in section II.C.7.a.(1)(i).
  • We propose to calculate the total quality percent score for MIPS eligible clinicians using the CMS Web Interface according to the methodology described in section II.C.7.a.(1)(h)(2) of this proposed rule.
  • We propose to establish a separate MIPS final list of quality measures for each Other MIPS APM that would be the quality measure list used for purposes of the APM scoring standard.
  • We propose to calculate the MIPS quality performance category score for Other MIPS APMs using MIPS APM-specific quality measures. For purposes of the APM scoring standard, we would score only measures that: (1) Are tied to payment as described under the terms of the APM, (2) are available for scoring near the close of the MIPS submission period, (3) have a minimum of 20 cases available for reporting, and (4) have an available benchmark.
  • We propose to only use the MIPS APM quality measure data that are submitted by the close of the MIPS submission period and are available for scoring in time for inclusion to calculate a MIPS quality performance category score.
  • We propose that, for the APM scoring standard, the benchmark score used for a quality measure would be the benchmark used in the MIPS APM for calculation of the performance based payments, where such a benchmark is available. If the APM does not produce a benchmark score for a reportable measure that is included on the APM measures list, we would use the benchmark score for the measure that is used for the MIPS quality performance category generally (outside of the APM scoring standard) for that performance year, provided the measure specifications for the measure are the same under both the MIPS final list and the APM measures list.
  • We propose that the minimum number of quality measures required to be reported for the APM scoring standard would be the minimum number of quality measures that are required within the MIPS APM and are collected and available in time to be included in the calculation for the APM Entity score under the APM scoring standard. We propose that if an APM Entity submits some, but not all of the measures required by the MIPS APM by the close of the MIPS submission period, the APM Entity would receive points for the measures that were submitted, but would receive a score of zero for each remaining measure between the number of measures reported and the number of measures required by the APM that were available for scoring.
  • We propose that the benchmark score used for a quality measure would be the benchmark used by the MIPS APM for calculation of the performance based payments within the APM, if possible, in order to best align the measure performance outcomes between the two programs. We are proposing that for measures that are pay for reporting or which do not measure performance on a continuum of performance, we will consider these measures to be lacking a benchmark and they will be treated as such.
  • We propose to score quality measure performance under the APM scoring standard using a percentile distribution, separated by decile categories, as described in the finalized MIPS quality scoring methodology. We propose to use a graduated points-assignment approach, where a measure is assigned a continuum of points out to one decimal place, based on its place in the decile.
  • We propose that each APM Entity that reports on quality measures would receive between 1 and 10 achievement points for each measure reported that can be reliably scored against a benchmark, up to the number of Start Printed Page 30091measures that are required to be reported by the APM.
  • We propose that APM Entities in MIPS APMs, like other MIPS eligible clinicians, would be eligible to receive bonus points for the MIPS quality performance category for reporting on high priority measures or measures submitted via CEHRT. For each Other MIPS APM, we propose to identify whether any of their available measures meets the criteria to receive a bonus, and add the bonus points to the quality achievement points.
  • Beginning in the 2018 performance year, we propose to score improvement as well as achievement in the quality performance category. For the APM scoring standard, we propose that the improvement percentage points would be awarded based on the following formula:

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

  • We propose that the APM Entity's total quality performance category score would be equal to [(achievement points + bonus points)/total available achievement points] + quality improvement score.
  • Under the APM scoring standard, we propose that if a MIPS eligible clinician who qualifies for a zero percent weighting of the advancing care information performance category in the final score is part of a TIN that includes one or more MIPS eligible clinicians who do not qualify for a zero percent weighting, we would not apply the zero percent weighting to the qualifying MIPS eligible clinician, and the TIN would still be required to report on behalf of the group, although the TIN would not need to report data for the qualifying MIPS eligible clinician.
  • We propose to maintain the cost performance category weight of zero for Other MIPS APMs under the APM scoring standard for the 2020 MIPS payment year and subsequent MIPS payment years. Because the cost performance category would be reweighted to zero that weight would need to be redistributed to other performance categories. We propose to align the Other MIPS APM performance category weights with those proposed for Web Interface reporters and weight the quality performance category to 50 percent, the improvement activities performance category to 20 percent, and the advancing care information performance category to 30 percent of the APM Entity final score.
  • It is possible that none of the Other MIPS APM's measures would be available for calculating a quality performance category score by or shortly after the close of the MIPS submission period, for example, due to changes in clinical practice guidelines. In addition, the MIPS eligible clinicians in an APM Entity may qualify for a zero percent weighting for the advancing care information performance category. In such instances, under the APM scoring standard, we propose to reweight the affected performance category to zero.
  • Beginning with the 2018 performance year, we propose that MIPS eligible clinicians whose MIPS payment adjustment is based on their score under the APM scoring standard will receive performance feedback as specified under section 1848(q)(12) of the Act for the quality, advancing care information, and improvement activities performance categories to the extent data are available for the MIPS performance year. Further, we propose that in cases where the MIPS APM performance category has been weighted to zero for that performance year, we would not provide performance feedback on that MIPS performance category.

The following tables represent the measures being introduced for notice and comment, and would serve as the measure set used by participants in the identified MIPS APMs in order to create a MIPS score under the APM scoring standard, as described in section II.C.6.g.(3)(b)(ii)(A) of this proposed rule. Once this list is finalized, no measures may be added to this list.

Table 14—MIPS APM Measures List—Oncology Care Model

Measure nameNQF/Quality number (if applicable)National quality strategy domainMeasure descriptionPrimary measure steward
Risk-adjusted proportion of patients with all-cause hospital admissions within the 6-month episodeNAEffective Clinical CarePercentage of OCM-attributed FFS beneficiaries who were had an acute-care hospital stay during the measurement periodNA
Risk-adjusted proportion of patients with all-cause ED visits or observation stays that did not result in a hospital admission within the 6-month episodeNAEffective Clinical CarePercentage of OCM-attributed FFS beneficiaries who had an ER visit that did not result in a hospital stay during the measurement period
Proportion of patients who died who were admitted to hospice for 3 days or moreNAEffective Clinical CarePercentage of OCM-attributed FFS beneficiaries who died and spent at least 3 days in hospice during the measurement time periodNA
Oncology: Medical and Radiation—Pain Intensity Quantified0384/143Person and Caregiver Centered ExperiencePercentage of patient visits, regardless of patient age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy in which pain intensity is quantifiedPhysician Consortium for Performance Improvement Foundations (PCPI).
Oncology: Medical and Radiation—Plan of Care for Pain0383/144Person and Caregiver Centered ExperiencePercentage of visits for patients, regardless of age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy who report having pain with a documented plan of care to address painAmerican Society of Clinical Oncology.
Preventive Care and Screening: Screening for Depression and Follow-Up Plan0418/134Community/Population HealthPercentage of patients aged 12 and older screened for depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screenCenters for Medicare & Medicaid Services.
Start Printed Page 30092
Patient-Reported Experience of CareNAPerson and Caregiver Centered ExperienceSummary/Survey Measures may include: —Overall measure of patient experience —Exchanging Information with Patients —Access —Shared Decision Making —Enabling Self-Management —Affective CommunicationNA
Prostate Cancer: Adjuvant Hormonal Therapy for High or Very High Risk Prostate Cancer0390/104Effective Clinical CarePercentage of patients, regardless of age, with a diagnosis of prostate cancer at high or very high risk of recurrence receiving external beam and radiotherapy to the prostate who were prescribed adjuvant hormonal therapy (GnRH [gonadotropin releasing hormone] agonist or antagonist)American Urological Association Education and Research.
Adjuvant chemotherapy is recommended or administered within 4 months (120 days) of diagnosis to patients under the age of 80 with AJCC III (lymph node positive) colon cancer0223Communication and Care CoordinationPercentage of patients under the age of 80 with AJCC III (lymph node positive) colon cancer for whom adjuvant chemotherapy is recommended and not received or administered within 4 months (120 days) of diagnosisCommission on Cancer, American College of Surgeons.
Combination chemotherapy is recommended or administered within 4 months (120 days) of diagnosis for women under 70 with AJCC T1cN0M0, or Stage IB—III hormone receptor negative breast cancer0559Communication and Care CoordinationPercentage of female patients, age >18 at diagnosis, who have their first diagnosis of breast cancer (epithelial malignancy), at AJCC stage T1cN0M0 (tumor greater than 1 cm), or Stage IB—III, whose primary tumor is progesterone and estrogen receptor negative recommended for multiagent chemotherapy (recommended or administered) within 4 months (120 days) of diagnosisCommission on Cancer, American College of Surgeons.
Trastuzumab administered to patients with AJCC stage I (T1c)—III and human epidermal growth factor receptor 2 (HER2) positive breast cancer who receive adjuvant chemotherapy1858/450Efficiency and Cost ReductionProportion of female patients (aged 18 years and older) with AJCC stage I (Tlc)—Ill, human epidermal growth factor receptor 2 (HER2) positive breast cancer receiving adjuvant chemotherapyAmerican Society of Clinical Oncology.
Breast Cancer: Hormonal Therapy for Stage I (T1b)—IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer0387Communication and Care CoordinationPercentage of female patients aged 18 years and older with Stage I (T1b) through IIIC, ER or PR positive breast cancer who were prescribed tamoxifen or aromatase inhibitor (AI) during the 12-month reporting periodAMA-convened Physician Consortium for Performance Improvement.
Documentation of Current Medications in the Medical Record0419/130Patient SafetyPercentage of visits for patients aged 18 years and older for which the eligible clinician attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the counters, herbals, and vitamin/mineral/dietary AND must contain the medications' name, dosage, frequency and route of administrationCenters for Medicare & Medicaid Services.

Table 15—MIPS APM Measures List—Comprehensive ESRD Care

Measure nameNQF/Quality number (if applicable)National quality strategy domainMeasure descriptionPrimary measure steward
ESCO Standardized Mortality Ratio0101/154Patient SafetyFalls: Risk Assessment: Percentage of patients aged 65 years and older with a history of falIs who had a risk assessment for falls completed within for Quality 12 monthsNational Committee for Quality Assurance.
Falls: Screening, Risk Assessment and Plan of Care to Prevent Future Falls0101/154Communication and CoordinationFalls: Risk Assessment: Percentage of patients aged 65 years and older with a history of falIs who had a risk assessment for falls completed within for Quality 12 monthsNational Committee for Quality Assurance.
Advance Care Plan0326/47Patient SafetyPercentage of patients aged 65 years and older who have an advance care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an advance care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care planNational Committee for Quality Assurance.
Start Printed Page 30093
ICH-CAHPS: Nephrologists' Communication and Caring0258Person and Caregiver Centered Experience and OutcomeSummary/Survey Measures may include: —Getting timely care, appointments, and information —How well providers communicate —Patients' rating of provider —Access to specialists —Health promotion and education —Shared decision-making —Health status and functional status —Courteous and helpful office staff —Care coordination —Between visit communication —Helping you to take medications as directed, and —Stewardship of patient resourcesAgency for Healthcare Research and Quality.
ICH-CAHPS: ICH-CAHPS: Rating of Dialysis Center0258Person and Caregiver Centered Experience and OutcomeComparison of services and quality of care that dialysis facilities provide from the perspective of ESRD patients receiving in-center hemodialysis care. Patients will assess their dialysis providers, including nephrologists and medical and non-medical staff, the quality of dialysis care they receive, and information sharing about their diseaseAgency for Healthcare Research and Quality.
ICH-CAHPS: Quality of Dialysis Center Care and Operations0258Comparison of services and quality of care that dialysis facilities provide from the perspective of ESRD patients receiving in-center hemodialysis care. Patients will assess their dialysis providers, including nephrologists and medical and non-medical staff, the quality of dialysis care they receive, and information sharing about their diseaseAgency for Healthcare Research and Quality.
ICH-CAHPS: Providing Information to Patients0258Comparison of services and quality of care that dialysis facilities provide from the perspective of ESRD patients receiving in-center hemodialysis care. Patients will assess their dialysis providers, including nephrologists and medical and non-medical staff, the quality of dialysis care they receive, and information sharing about their diseaseAgency for Healthcare Research and Quality.
ICH-CAHPS: Rating of Kidney Doctors0258Comparison of services and quality of care that dialysis facilities provide from the perspective of ESRD patients receiving in-center hemodialysis care. Patients will assess their dialysis providers, including nephrologists and medical and non-medical staff, the quality of dialysis care they receive, and information sharing about their diseaseAgency for Healthcare Research and Quality.
ICH-CAHPS: Rating of Dialysis Center Staff ICH-CAHPS: Rating of Dialysis Center0258Comparison of services and quality of care that dialysis facilities provide from the perspective of ESRD patients receiving in-center hemodialysis care. Patients will assess their dialysis providers, including nephrologists and medical and non-medical staff, the quality of dialysis care they receive, and information sharing about their diseaseAgency for Healthcare Research and Quality.
Medication Reconciliation Post Discharge0554Communication and Care CoordinationThe percentage of discharges from any inpatient facility (e.g. hospital, skilled nursing facility, or rehabilitation facility) for patients 18 years of age and older seen within 30 days following the discharge in the office by the physicians, prescribing practitioner, registered nurse, or clinical pharmacist providing on-going care for whom the discharge medication list was reconciled with the current medication list in the outpatient medical record. This measure is reported as three rates stratified by age group:National Committee for Quality Assurance.
• Reporting Criteria 1: 18-64 years of age
• Reporting Criteria 2: 65 years and older
• Total Rate: All patients 18 years of age and Older
Diabetes Care: Eye Exam0055/117Effective Clinical CarePercentage of patients 18-75 years of age with diabetes who had a retinal or dilated eye exam by an eye care professional during the measurement period or a negative retinal exam (no evidence of retinopathy) in the 12 months prior to the measurement periodNational Committee for Quality Assurance.
Diabetes Care: Foot Exam0056/163Effective Clinical CarePercentage of patients 18-75 years of age with diabetes (type 1 and type 2) who received a foot exam (visual inspection and sensory exam with mono filament and a pulse exam) during the previous measurement yearNational Committee for Quality Assurance.
Influenza Immunization for the ESRD Population0041/110, 0226Community/Population HealthPercentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunizationKidney Care Quality Alliance (KCQA).
Pneumococcal Vaccination Status0043/111Community/Population HealthPercentage of patients 65 years of age and older who have ever received a pneumococcal vaccineNational Committee for Quality Assurance.
Start Printed Page 30094
Screening for Clinical Depression and Follow-Up Plan0418/134Community/Population HealthPercentage of patients aged 12 and older screened for depression on the date of the encounter and using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screenCenters for Medicare and Medicaid Services.
Tobacco Use: Screening and Cessation Intervention0028/226Community/Population HealthPercentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco userPhysician Consortium for Performance Improvement Foundations (PCPI).

Table 16—MIPS APM Measures List—Comprehensive Primary Care Plus (CPC+)

Measure nameNQF/Quality number (if applicable)National quality strategy domainMeasure descriptionPrimary measure steward
Depression Remission at Twelve Months0710/370Effective Clinical CarePatients age 18 and older with major depression or dysthymia and an initial Patient Health Questionnaire (PHQ-9) score greater than nine who demonstrate remission at twelve months (+/− 30 days after an index visit) defined as a PHQ-9 score less than five. This measure applies to both patients with newly diagnosed and existing depression whose current PHQ-9 score indicates a need for treatmentMinnesota Community Measurement
Controlling High Blood Pressure0018/236Effective Clinical CarePercentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90 mmHg) during the measurement periodNational Committee for Quality Assurance
Diabetes: Eye Exam0055/117Effective Clinical CarePercentage of patients 18-75 years of age with diabetes who had a retinal or dilated eye exam by an eye care professional during the measurement period or a negative retinal exam (no evidence of retinopathy) in the 12 months prior to the measurement periodNational Committee for Quality Assurance
Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)0059/001Effective Clinical CarePercentage of patients 18-75 years of age with diabetes who had hemoglobin A1c >9.0% during the measurement periodNational Committee for Quality Assurance
Use of High-Risk Medications in the Elderly0022/238Patient SafetyPercentage of patients 66 years of age and older who were ordered high-risk medications. Two rates are reportedNational Committee for Quality Assurance
a. Percentage of patients who were ordered at least one high-risk medication
b. Percentage of patients who were ordered at least two different high-risk medications
Dementia: Cognitive AssessmentNA/281Effective Clinical CarePercentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of cognition is performed and the results reviewed at least once within a 12-month periodPhysician Consortium for Performance Improvement Foundation (PCPI)
Falls: Screening for Future Fall Risk0101/318Patient SafetyPercentage of patients 65 years of age and older who were screened for future fall risk at least once during the measurement periodNational Committee for Quality Assurance
Initiation and Engagement of Alcohol and Other Drug Dependence Treatment0004/305Effective Clinical CarePercentage of patients 13 years of age and older with a new episode of alcohol and other drug (AOD) dependence who received the following. Two rates are reported a. Percentage of patients who initiated treatment within 14 days of the diagnosisNational Committee for Quality Assurance
b. Percentage of patients who initiated treatment and who had two or more additional services with an AOD diagnosis within 30 days of the initiation visit
Closing the Referral Loop: Receipt of Specialist ReportNA/374Communication and Care CoordinationPercentage of Patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referredCenters for Medicare and Medicaid Services
Cervical Cancer Screening0032/309Effective Clinical CarePercentage of women 21-64 years of age, who were screened for cervical cancer using either of the following criteriaNational Committee for Quality Assurance
• Women age 21-64 who had cervical cytology performed every 3 years
• Women age 30-64 who had cervical cytology/human papillomavirus (HPV) co-testing performed every 5 years
Colorectal Cancer Screening0034/113Effective Clinical CarePercentage of patients, 50-75 years of age who had appropriate screening for colorectal cancerNational Committee for Quality Assurance
Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention0028/226Community/Population HealthPercentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco userPhysician Consortium for Performance Improvement Foundations (PCPI)
Start Printed Page 30095
Breast Cancer Screening2372/112Effective Clinical CarePercentage of women 50-74 years of age who had a mammogram to screen for breast cancerNational Committee for Quality Assurance
Preventive Care and Screening: Influenza Immunization0041/110Community/Population HealthPercentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunizationPCPI(R) Foundation (PCPI[R])
Pneumonia Vaccination Status for Older Adults0043/111Community/Population HealthPercentage of patients 65 years of age and older who have ever received a pneumococcal vaccineNational Committee for Quality Assurance
Diabetes: Medical Attention for Nephropathy0062/119Effective Clinical CareThe percentage of patients 18-75 years of age with diabetes who had a nephropathy screening test or evidence of nephropathy during the measurement periodNational Committee for Quality Assurance
Ischemic Vascular Disease (IVD): Use of Aspirin or Another0068/204Effective Clinical CarePercentage of patients 18 years of age and older who were diagnosed with acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascular disease (IVD) during the measurement period, and who had documentation of use of aspirin or another antiplatelet during the measurement periodNational Committee Quality Assurance
Hypertension: Improvement in Blood PressureNA/373Effective Clinical CarePercentage of patients aged 18-85 years of age with a diagnosis of hypertension whose blood pressure improved during the measurement periodCenters for Medicare & Medicaid Services (CMS)
Preventive Care and Screening: Screening for Depression and Follow-Up Plan0418/134Community/Population HealthPercentage of patients aged 12 years and older screened for depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screenCenters for Medicare & Medicaid Services (CMS)
Diabetes: Foot Exam0056/163Effective Clinical CareThe percentage of patients 18-75 years of age with diabetes (type 1 and type 2) who received a foot exam (visual inspection and sensory exam with mono filament and a pulse exam) during the measurement yearNational Committee for Quality Assurance
Statin Therapy for the Prevention and Treatment of Cardiovascular DiseaseNA/438Not provided in the measurePercentage of the following patients—all considered at high risk of cardiovascular events—who were prescribed or were on statin therapy during the measurement period: * Adults aged ≥21 years who were previously diagnosed with or currently have an active diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD); ORQuality Insights
* Adults aged ≥21 years who have ever had a fasting or direct low-density lipoprotein cholesterol (LDL-C) level ≥190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial or pure hypercholesterolemia; OR
* Adults aged 40-75 years with a diagnosis of diabetes with a fasting or direct LDL-C level of 70-189 mg/dL
Inpatient Hospital Utilization (IHU)NAFor members 18 years of age and older, the risk-adjusted ratio of observed to expected acute inpatient discharges during the measurement year reported by Surgery, Medicine, and TotalNational Committee for Quality Assurance
Emergency Department Utilization (EDU)NAFor members 18 years of age and older, the risk-adjusted ratio of observed to expected emergency department (ED) visits during the measurement yearNational Committee for Quality Assurance
Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan0421Community/Population HealthPercentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous six months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous six months of the current encounter. Normal Parameters: Age 18 years and older BMI ≥18.5 and <25 kg/m2Centers for Medicare & Medicaid Services (CMS)
CAHPSCPC+ specific; different than CAHPS for MIPSCG-CAHPS Survey 3.0AHRQ

7. MIPS Final Score Methodology

For the 2020 MIPS payment year, we intend to build on the scoring methodology we finalized for the transition year, which allows for accountability and alignment across the performance categories and minimizes burden on MIPS eligible clinicians, while continuing to prepare MIPS eligible clinicians for the performance threshold required for the 2021 MIPS payment year. Our rationale for our scoring methodology continues to be grounded in the understanding that the MIPS scoring system has many components and numerous moving parts.

As we continue to move forward in implementing the MIPS program, we strive to balance the statutory requirements and programmatic goals Start Printed Page 30096with the ease of use, stability, and meaningfulness for MIPS eligible clinicians, while also emphasizing simplicity and scoring that is understandable for MIPS eligible clinicians. In this section, we propose refinements to the performance standards, the methodology for determining a score for each of the four performance categories (the “performance category score”), and the methodology for determining a final score based on the performance category scores.

We intend to continue the transition of MIPS by proposing the following policies:

  • Continuation of many transition year scoring policies in the quality performance category, with an adjustment to the number of achievement points available for measures that fail to meet the data completeness criteria, to encourage MIPS eligible clinician to meet data completeness while providing an exception for small practices;
  • An improvement scoring methodology that rewards MIPS eligible clinicians who improve their performance in the quality and cost performance categories;
  • A new scoring option for the quality and cost performance categories that allows facility-based MIPS eligible clinicians to be scored based on their facility's performance;
  • Special considerations for MIPS eligible clinicians in small practices or those who care for complex patients; and
  • Policies that allow multiple pathways for MIPS eligible clinicians to receive a neutral to positive MIPS payment adjustment.

We believe these sets of proposed policies will help clinicians smoothly transition from the transition year to the 2021 MIPS payment year, for which the performance threshold (which represents the final score that would earn a neutral MIPS adjustment) will be either the mean or median (as selected by the Secretary) of the MIPS final scores for all MIPS eligible clinicians from a previous period specified by the Secretary.

Unless otherwise noted, for purposes of this section II.C.7. on scoring, the term “MIPS eligible clinician” will refer to MIPS eligible clinicians that submit data and are scored at either the individual- or group-level, including virtual groups, but will not refer to MIPS eligible clinicians who elect facility-based scoring. The scoring rules for facility-based measurement are discussed in section II.C.7.a.(4). of this proposed rule. We also note that the APM scoring standard applies to APM Entities in MIPS APMs, and those policies take precedence where applicable; however, where those policies do not apply, scoring for MIPS eligible clinicians as described in this section II.C.7. on scoring will apply. We refer readers to section II.C.6.g. of this proposed rule for additional information about the APM scoring standard.

a. Converting Measures and Activities Into Performance Category Scores

(1) Policies That Apply Across Multiple Performance Categories

The detailed policies and proposals for scoring the four performance categories are described in detail in section II.C.7.a. of this proposed rule. However, as the four performance categories collectively create a single MIPS final score, there are several policies that apply across categories, which we discuss in section II.C.7.a.(1) of this proposed rule.

(a) Performance Standards

In accordance with section 1848(q)(3) of the Act, in the CY 2017 Quality Payment Program final rule, we finalized performance standards for the four performance categories. We refer readers to the CY 2017 Quality Payment Program final rule for a description of the performance standards against which measures and activities in the four performance categories are scored (81 FR 77271 through 77272).

As discussed in section II.C.7.a.(1)(b)(i) of this proposed rule, we are proposing to add an improvement scoring standard to the quality and cost performance categories starting for the 2020 MIPS payment year.

(b) Policies Related to Scoring Improvement

(i) Background

In accordance with section 1848(q)(5)(D)(i) of the Act, beginning with the 2020 MIPS payment year, if data sufficient to measure improvement are available, the final score methodology shall take into account improvement of the MIPS eligible clinician in calculating the performance score for the quality and cost performance categories and may take into account improvement for the improvement activities and advancing care information performance categories. In addition, section 1848(q)(3)(B) of the Act provides that the Secretary, in establishing performance standards for measures and activities for the MIPS performance categories, shall consider: Historical performance standards; improvement; and the opportunity for continued improvement. Section 1848(q)(5)(D)(ii) of the Act also provides that achievement may be weighted higher than improvement.

In the CY 2017 Quality Payment Program final rule, we summarized public comments received on the proposed rule regarding potential ways to incorporate improvement into the scoring methodology moving forward, including approaches based on methodologies used in the Hospital VBP Program, the Shared Savings Program, and Medicare Advantage 5-star Ratings Program (81 FR 77306 through 77308). We did not finalize a policy at that time on this topic and indicated we would take comments into account in developing a proposal for future rulemaking.

When considering the applicability of these programs to MIPS, we looked at the approach that was used to measure improvement for each of the programs and how improvement was incorporated into the overall scoring system. An approach that focuses on measure-level comparison enables a more granular assessment of improvement because performance on a specific measure can be considered and compared from year to year. All options that we considered last year use a standard set of measures that do not provide for choice of measures to assess performance; therefore, they are better structured to compare changes in performance based on the same measure from year to year. The aforementioned programs do not use a category-level approach; however, we believe that a category-level approach would provide a broader perspective, particularly in the absence of a standard set of measures, because it would allow for a more flexible approach that enables MIPS eligible clinicians to select measures and data submission mechanisms that can change from year to year and be more appropriate to their practice in a given year.

We believe that both approaches are viable options for measuring improvement. Accordingly, we believe that an appropriate approach for measuring improvement for the quality performance category and the cost performance category should consider the unique characteristics of each performance category rather than necessarily applying a uniform approach across both performance categories. For the quality performance category, clinicians are offered a variety of different measures which can be submitted by different mechanisms, rather than a standard set of measures or a single data submission mechanism. Start Printed Page 30097For the cost performance category, however, clinicians are scored on the same set of cost measures to the extent each measure is applicable and available to them; clinicians cannot choose which cost measures they will be scored on. In addition, all of the cost measures are derived from administrative claims data with no additional submission required by the clinician.

When considering the applicability of these programs to MIPS, we also considered how scoring improvement is incorporated into the overall scoring system, including when only achievement or improvement is incorporated into a final score or when improvement and achievement are both incorporated into a final score.

We considered whether we could adapt the Hospital VBP Program's general approach for assessing improvement to MIPS and note that many commenters, in response to the CY 2017 Quality Payment Program proposed rule, recommended this methodology for MIPS because it is familiar to the health care community. However, we decided that the Hospital VBP Program's improvement scoring methodology, which compares changes in performance based on the same measure from year to year, is not fully translatable to MIPS for the quality performance category and the cost performance category. The scoring methodology used to assess achievement in the Hospital VBP Program, as required by section 1886(o)(5)(B)(ii) of the Act, does not reward points for achievement in the same method as MIPS, because hospitals that fall below the achievement threshold (the median performance during the benchmark period) are not awarded achievement points. We refer readers to the Hospital Inpatient VBP Program Final Rule (76 FR 26516 through 26525) for additional discussion of the Hospital VBP Program's scoring methodology. In addition, the Hospital VBP Program requires the use of either the achievement score or the improvement points, but not both, for the Program's performance scoring calculation. Adopting the Hospital VBP Program method for MIPS would require significant changes to the scoring methodology used for the quality and cost performance categories. For the quality performance category, there are a wide variety of measures available in MIPS, and clinicians have flexibility in selecting measures and submission mechanisms, with the potential for clinicians to select different measures from year to year, which would affect our ability to capture performance changes at the measure level.

We continue to believe that flexibility for clinicians to select meaningful measures is appropriate for MIPS, especially for the quality performance category. The Hospital VBP Program methodology, which relies on consistent measures from year to year in order to track improvement, would limit our ability to measure improvement in MIPS.

We also considered adopting the Shared Savings Program's approach for assessing improvement, where participants can receive bonus points for improving on quality measures over time. The Shared Savings Program methodology could be adopted without an underlying change to the scoring of achievement in the quality and cost performance categories with an approach that considers both achievement and improvement in its overall scoring calculation and would align MIPS and the Shared Savings Program. However, we believe that the Shared Savings Program's improvement methodology would not be appropriate for the MIPS quality performance category because we are again concerned about the wide variety of quality measures available in MIPS and the flexibility clinicians have in selecting measures and submission mechanisms that could affect our ability to capture performance changes at the measure level. We seek to balance a system that allows for meaningful measurement to clinicians and accommodates the various practice types by allowing for a choice of measures and submission mechanisms that may differ from year to year for the quality performance category. However, as we discuss in section II.C.7.a.(3)(a) of this proposed rule, we do believe the Shared Savings Program measure level methodology could be translated for cost measures in the cost performance category.

Finally, we also considered adopting the Medicare Advantage Program's 5-Star Rating approach for assessing improvement, where Medicare Advantage contracts are rated on quality and performance measures. Under this approach, we would identify an overall “improvement measure score” by comparing the underlying numeric data for measures from the prior year with the data from measures for the performance period. To obtain an “improvement measure score” MIPS eligible clinicians would need to have data for both years in at least half of the required measures for the quality performance category (81 FR 77307). We are again concerned that the wide variety of measures available in MIPS and the flexibility clinicians have in selecting different measures and submission mechanisms from year to year could affect our ability to capture performance changes at the measure level, particularly for the quality performance category. Accordingly, we do not believe this is an appropriate approach for the quality performance category. Although this approach could be considered for the cost performance category, we believe that the Shared Savings Program is more analogous to MIPS and that the improvement methodology used in that program is one with which more stakeholders in MIPS would be familiar.

After taking all of this into consideration, we are proposing two different approaches for scoring improvement from year to year. As described in section II.C.7.a.(2)(i)(i) of this proposed rule, we are proposing to measure improvement at the performance category level for the quality performance category score. Because clinicians can elect the submission mechanisms and quality measures that are most meaningful to their practice, and these choices can change from year to year, we want a flexible methodology that allows for improvement scoring even when the quality measures change. This is particularly important as we encourage MIPS eligible clinicians to move away from topped out measures and toward more outcome measures. We do not want the flexibility that is offered to MIPS eligible clinicians in the quality performance category to limit clinicians' ability to move towards outcome measures, or limit our ability to measure improvement. Our proposal for taking improvement into account as part of the quality performance category score is addressed in detail in sections II.C.7.a.(2)(i) through II.C.7.a.(2)(j) of this proposed rule.

We believe that there is reason to adopt a different methodology for scoring improvement for the cost performance category from that used for the quality performance category. In contrast to the quality performance category, for the cost performance category, MIPS eligible clinicians do not have a choice in measures or submission mechanisms; rather, all MIPS eligible clinicians are assessed on all measures based on the availability and applicability of the measure to their practice, and all measures are derived from administrative claims data. Therefore, for the cost performance category, we propose in section II.C.7.a.(3)(a)(i) of this proposed rule to measure improvement at the measure Start Printed Page 30098level. We also note, that while we are statutorily required to measure improvement for the cost performance category beginning with the second MIPS payment year if data sufficient to measure improvement is available, we are also proposing at II.C.6.d.(2) of this proposed rule to weight the cost performance category at zero percent for the 2018 MIPS performance period/2020 MIPS payment year. Therefore, the improvement score for the cost performance category would not affect the MIPS final score for the 2018 MIPS performance period/2020 MIPS payment year and would be for informational purposes only.

We are not proposing to score improvement in the improvement activities performance category or the advancing care information performance category at this time, though we may address improvement scoring for these performance categories in future rulemaking.

We propose to amend § 414.1380(a)(1)(i) to add that improvement scoring is available for performance in the quality performance category and for the cost performance category at § 414.1380(a)(1)(ii) beginning with the 2020 MIPS payment year.

We invite public comment on our proposals to score improvement for the quality and cost performance categories starting with the 2020 MIPS payment year.

(ii) Data Sufficiency Standard To Measure Improvement

Section 1848(q)(5)(D)(i) of the Act requires us to measure improvement for the quality and cost performance categories of MIPS if data sufficient to measure improvement are available, which we interpret to mean that we would measure improvement when we can identify data from a current performance period that can be compared to data from a prior performance period or data that compares performance from year to year. In section II.C.7.a.(2)(i)(ii) of this proposed rule, we propose for the quality performance category that we would measure improvement when data are available because there is a performance category score for the prior performance period. In section II.C.7.a.(3)(a)(i) of this proposed rule, we propose for the cost performance category that we would measure improvement when data are available which is when there is sufficient case volume to provide measurable data on measures in subsequent years with the same identifier. We refer readers to the noted sections for details on these proposals.

(c) Scoring Flexibility for ICD-10 Measure Specification Changes During the Performance Period

The quality and cost performance categories rely on measures that use detailed measure specifications that include ICD-10-CM/PCS (“ICD-10”) code sets. We annually issue new ICD-10 coding updates, which are effective from October 1, through September 30 (https://www.cms.gov/​Medicare/​Coding/​ICD10/​ICD10OmbudsmanandICD10CoordinationCenterICC.html). As part of this update, codes are added as well as removed from the ICD-10 code set.

To provide scoring flexibility for MIPS eligible clinicians and groups for measures impacted by ICD-10 coding changes in the final quarter of the Quality Payment Program performance period—which may render the measures no longer comparable to the historical benchmark—we propose at § 414.1380(b)(1)(xviii) and § 414.1320(c)(2) to provide that we will assess performance on measures considered significantly impacted by ICD-10 updates based only on the first 9 months of the 12-month performance period (for example, January 1, 2018 through September 30, 2018, for the 2018 MIPS performance period). We believe it would be appropriate to assess performance for significantly impacted measures based on the first 9 months of the performance period, rather than the full 12 months, because the indicated performance for the last quarter could be affected by the coding changes rather than actual differences in performance. Performance on measures that are not significantly impacted by changes to ICD-10 codes would continue to be assessed on the full 12-month performance period (January 1 through December 31).

Any measure that relies on an ICD-10 code which is added, modified, or removed, such as in the measure numerator, denominator, exclusions, or exceptions, could have an impact on the indicated performance on the measure, although the impact may not always be significant. We propose an annual review process to analyze the measures that have a code impact and assess the subset of measures significantly impacted by ICD-10 coding changes during the performance period. Depending on the data available, we anticipate that our determination as to whether a measure is significantly impacted by ICD-10 coding changes would include these factors: A more than 10 percent change in codes in the measure numerator, denominator, exclusions, and exceptions; guideline changes or new products or procedures reflected in ICD-10 code changes; and feedback on a measure received from measure developers and stewards. We considered an approach where we would consider any change in ICD-10 coding to impact performance on a measure and thus only rely on the first 9 months of the 12-month performance period for such measures. However, we believe such an approach would be too broad and truncate measurement for too many measures where performance may not be significantly affected. We believe that our proposed approach ensures the measures on which individual MIPS eligible clinicians and groups will have their performance assessed are accurate for the performance period and are consistent with the benchmark set for the performance period.

We propose to publish on the CMS Web site which measures are significantly impacted by ICD-10 coding changes and would require the 9-month assessment. We propose to publish this information by October 1st of the performance period if technically feasible, but by no later than the beginning of the data submission period, which is January 1, 2019 for the 2018 performance period.

We request comment on the proposal to address ICD-10 measures specification changes during the performance period by relying on the first 9 months of the 12-month performance period. We also request comment on potential alternate approaches to address measures that are significantly impacted due to ICD-10 changes during the performance period, including the factors we might use to determine whether a measure is significantly impacted.

(2) Scoring the Quality Performance Category for Data Submission via Claims, Data Submissions via EHR, Third Party Data Submission Options, CMS Web Interface, and Administrative Claims

Many comments submitted in response to the CY 2017 Quality Payment Program final rule requested additional clarification on our finalized scoring methodology for the 2019 MIPS payment year. To provide further clarity to MIPS eligible clinicians about the transition year scoring policies, before describing our proposed scoring policies for the 2020 MIPS payment year, we provide a summary of the scoring policies finalized in the CY 2017 Quality Payment Program final rule along with examples of how they apply under several scenarios.

In the CY 2017 Quality Payment Program final rule (81 FR 77286 through Start Printed Page 3009977287), we finalized that the quality performance category would be scored by assigning achievement points to each submitted measure, which we refer to in this section of the proposed rule as “measure achievement points” and we propose to amend various paragraphs in § 414.1380(b)(1) to use this term in place of “achievement points”. MIPS eligible clinicians can also earn bonus points for certain measures (81 FR 77293 through 77294; 81 FR 77297 through 77299), which we refer to as “measure bonus points”, and we propose to amend § 414.1380(b)(1)(xiii) (which we propose to redesignate as § 414.1380(b)(1)(xiv) in this proposed rule),[7] § 414.1380(b)(1)(xiv) (which we propose to redesignate as § 414.1380(b)(1)(xv) in this proposed rule), and § 414.1380(b)(1)(xv) (which we propose to redesignate as § 414.1380(b)(1)(xvii) in this proposed rule) to use this term in place of “bonus points”. The measure achievement points assigned to each measure would be added with any measure bonus points and then divided by the total possible points (§ 414.1380(b)(1)(xv) (which we propose to redesignate as § 414.1380(b)(1)(xvii)). In this section of the proposed rule we refer to the total possible points as “total available measure achievement points”, and we propose to amend § 414.1380(b)(1)(xv) to use this term in place of “total possible points”. We also propose to amend these terms in § 414.1380(b)(1)(xiii)(D) (which we propose to redesignate as § 414.1380(b)(1)(xiv)(D) in this proposed rule), and § 414.1380(b)(1)(xiv) (which we propose to redesignate as § 414.1380(b)(1)(xv) in this proposed rule).

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

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

In the CY 2017 Quality Payment Program final rule, we finalized that for the quality performance category, an individual MIPS eligible clinician or group that submits data on quality measures via EHR, QCDR, qualified registry, claims, or a CMS-approved survey vendor for the CAHPS for MIPS survey will be assigned measure achievement points for 6 measures (1 outcome or, if an outcome measure is not available, other high priority measure and the next 5 highest scoring measures) as available and applicable, and will receive applicable measure bonus points for all measures submitted that meet the bonus criteria (81 FR 77282 through 77301).

In addition, for groups of 16 or more clinicians who meet the case minimum of 200, we will also automatically score the administrative claims-based all-cause hospital readmission measure as a seventh measure (81 FR 77287). For individual MIPS eligible clinicians and groups for whom the readmission measure does not apply, the denominator is generally 60 (10 available measure achievement points multiplied by 6 available measures). For groups for whom the readmission measure applies, the denominator is generally 70 points.

If we determined that a MIPS eligible clinician has fewer than 6 measures available and applicable, we will score only the number of measures that are available and adjust the denominator accordingly to the total available measure achievement points (81 FR 77291). We refer readers to section II.C.7.a.(2)(e) of this proposed rule, for a description of the validation process to determine measure availability.

For the 2019 MIPS payment year, a MIPS eligible clinician that submits quality measure data via claims, EHR, or third party data submission options (that is, QCDR, qualified registry, EHR, or CMS-approved survey vendor for the CAHPS for MIPS survey), can earn between 3 and 10 measure achievement points for quality measures submitted for the performance period of greater than or equal to 90 continuous days during CY 2017. A MIPS eligible clinician can earn measure bonus points (subject to a cap) if they submit additional high priority measures with a performance rate that is greater than zero, and that meet the case minimum and data completeness requirements, or submit a measure using an end-to-end electronic pathway. An individual MIPS eligible clinician that has 6 or more quality measures available and applicable will have 60 total available measure achievement points. For example, as shown in Table 17, if an individual MIPS eligible clinician submits 7 measures, including one required outcome measure and 2 additional high priority measures, the MIPS eligible clinician will be assigned points based on achievement for the required outcome measure and the next 5 measures with the highest number of measure achievement points. In this example, the second high priority measure has the lowest number of measure achievement points and therefore is not included in the total measure achievement points calculated (81 FR 77300), but the MIPS eligible clinician will still receive a bonus point for submitting a high priority measure (81 FR 77291 through 77294). We note that in the CY 2017 Quality Payment Program proposed rule, we proposed that bonus points would be available for high priority measures that are not scored (not included in the top 6 measures for the quality performance category score) as long as the measure has the required case minimum, data completeness, and has a performance rate greater than zero, because we believed these qualities would allow us to include the measure in future benchmark development (81 FR 28255). Although we received public comments on this policy, responded to those comments, and reiterated this proposal in the CY 2017 Quality Payment Program final rule (81 FR 77292), we would like to clarify that our policy to assign measure bonus points for high priority measures, even if the measure's achievement points are not included in the total measure achievement points for calculating the quality performance category percent score, as long as the measure has the required case minimum, data completeness, and has a performance rate greater than zero, applies beginning with the transition year. We propose to amend § 414.1380(b)(1)(xiii)(A) (which we propose to redesignate as § 414.1380(b)(1)(xiv)(A)) to state that measure bonus points may be included in the calculation of the quality performance category percent score regardless of whether the measure is included in the calculation of the total measure achievement points. We also propose a technical correction to the second sentence of that paragraph to state that to qualify for measure bonus points, each measure must be reported with sufficient case volume to meet the required case minimum, meet the required data completeness criteria, and Start Printed Page 30100not have a zero percent performance rate.

Table 17—Example Calculation of the Quality Performance Category Percent Score for an Individual for the Transition Year

Measure achievement pointsMeasure bonus points *Total available measure achievement pointsPerformance category percent score
Measure 1 (Outcome—required) Measure 23 6n/a n/a10 10(measure achievement points from 6 measures + measure bonus points)/total available measure achievement points.
Measure 36n/a10
Measure 46n/a10
Measure 56n/a10
Measure 6 (High priority)4110
Measure 7 (High priority)3 (not included for achievement)1n/a
Total31260(31+2)/60 = 55%
* Assumes the measures meet the required case minimum, data completeness, and has performance greater than zero. Assumes no bonus points for end-to-end electronic submission. This example does not apply to CMS Web Interface Reporters because individuals are not able to submit data via that mechanism.

A group of 16 or more clinicians will also be automatically scored on the hospital readmission measure if they meet the case minimum. Table 18 illustrates an example of a group that submitted the 6 required quality measures, including an additional high priority measure, and received 3 measure achievement points for each submitted measure and the all-cause readmission measure.

Table 18—Example Calculation of the Quality Performance Category Percent Score for a Group of 16 or More Clinicians, Non-CMS Web Interface Reporter for the Transition Year

Measure achievement pointsMeasure bonus points *Total available measure achievement pointsPerformance category percent score
Measure 1 (Outcome—required)3n/a10(measure achievement points from 7 measures + measure bonus points)/total available measure achievement points.
Measure 2 (High priority)3110
Measure 33n/a10
Measure 43n/a10
Measure 53n/a10
Measure 63n/a10
Measure 7—(readmission measure with 200+ cases)3n/a10
Total21170(21+1)/70 = 31.4%
* Assumes the measures meet the required case minimum, data completeness, and has performance greater than zero. Assumes no bonus points for end-to-end electronic submission.

In the CY 2017 Quality Payment Program final rule, we also finalized scoring policies specific to groups of 25 or more that submit their quality performance measures using the CMS Web Interface (81 FR 77278 through 77306).

Although we are not proposing to change the basic scoring system that we finalized in the CY 2017 Quality Payment Program final rule for the 2020 MIPS payment year, we are proposing several modifications to scoring the quality performance category, including adjusting scoring for measures that do not meet the data completeness criteria, adding a method for scoring measures submitted via multiple mechanisms, adding a method for scoring selected topped out measures, and adding a method for scoring improvement. We also note that in section II.C.7.a.(4) of this proposed rule, we are also proposing an additional option for facility-based scoring for the quality performance category.

(a) Quality Measure Benchmarks

We are not proposing to change the policies on benchmarking finalized in the CY 2017 Quality Payment Program final rule and codified at paragraphs (b)(1)(i) through (iii) of § 414.1380; however, we are proposing a technical correction to paragraphs (i) and (ii) to clarify that measure benchmark data are separated into decile categories based on percentile distribution, and that, other than using performance period data, performance period benchmarks are created in the same manner as historical benchmarks using decile categories based on a percentile distribution and that each benchmark must have a minimum of 20 individual clinicians or groups who reported on the measure meeting the data completeness requirement and case minimum case size criteria and performance greater than zero. We refer Start Printed Page 30101readers to the discussion at 81 FR 77282 for more details on that policy.

We note that in section II.C.2.c. of this proposed rule, we are proposing to increase the low-volume threshold which, because we include MIPS eligible clinicians and comparable APMs that meet our benchmark criteria in our measure benchmarks, could have an impact on our MIPS benchmarks, specifically by reducing the number of individual eligible clinicians and groups that meet the definition of a MIPS eligible clinician and contribute to our benchmarks. Therefore, we seek feedback on whether we should broaden the criteria for creating our MIPS benchmarks to include PQRS and any data from MIPS, including voluntary reporters, that meet our benchmark performance, case minimum and data completeness criteria when creating our benchmarks.

In the CY 2017 Quality Payment Program final rule, we did not stratify benchmarks by practice characteristics, such as practice size, because we did not believe there was a compelling rationale for such an approach, and we believed that stratifying could have unintended negative consequences for the stability of the benchmarks, equity across practices, and quality of care for beneficiaries (81 FR 77282). However, we sought comment on any rationales for or against stratifying by practice size we may not have considered. We note that we do create separate benchmarks for each of the following submission mechanisms: EHR submission options; QCDR and qualified registry submission options; claims submission options; CMS Web Interface submission options; CMS-approved survey vendor for CAHPS for MIPS submission options; and administrative claims submission options (for measures derived from claims data, such as the all-cause hospital readmission measure) (81 FR 77282).

Several commenters who responded to our solicitation of comment in the final rule supported stratifying measure benchmarks by practice size because the commenters believed it would help small practices, which have limited resources compared to larger practices, and because quality measures may have characteristics that are less favorable to small groups. One commenter recommended that we stratify by practice size during the 5 years in which technical assistance is available. One commenter recommended that we develop criteria for determining when a benchmark should be stratified by group size, and another commenter recommended if we do not stratify benchmarks by practice size, we adjust MIPS payment adjustments for practice size. Several commenters recommended that we stratify benchmarks beyond practice size and include adjustments for disease severity and socioeconomic status of patients, specialty or sub-specialty, geographic region, and/or site of service. One commenter specifically suggested that we use peer comparison groups when establishing measure benchmarks.

After consideration of the comments we received, we are not proposing to change our policies related to stratifying benchmarks by practice size for the 2020 MIPS payment year. For many measures, the benchmarks may not need stratification as they are only meaningful to certain specialties and only expected to be submitted by those certain specialists. We would like to further clarify that in the majority of instances our current benchmarking approach only compares like clinicians to like clinicians. We continue to believe that stratifying by practice size could have unintended negative consequences for the stability of the benchmarks, equity across practices, and quality of care for beneficiaries. However, we seek comment on methods by which we could stratify benchmarks, while maintaining reliability and stability of the benchmarks, to use in developing future rulemaking for future performance and payment years. Specifically, we seek comment on methods for stratifying benchmarks by specialty or by place of service. We also request comment on specific criteria to consider for stratifying measures, such as how we should stratify submissions by multi-specialty practices or by practices that operate in multiple places of service.

(b) Assigning Points Based on Achievement

In the CY 2017 Quality Payment Program final rule, we finalized at § 414.1380(b)(1) that a MIPS quality measure must have a measure benchmark to be scored based on performance. MIPS quality measures that do not have a benchmark (for example, because fewer than 20 MIPS eligible clinicians or groups submitted data that met our criteria to create a reliable benchmark) will not be scored based on performance (81 FR 77286). We are not proposing any changes to this policy, but we are proposing a technical correction to the regulatory text at § 414.1380(b)(1) to delete the term “MIPS” before “quality measure” in third sentence of that paragraph and to delete the term MIPS before “quality measures” in the fourth sentence of that paragraph because this policy applies to all quality measures, including the measures finalized for the MIPS program and the quality measures submitted through a QCDR that have been approved for MIPS.

We are also not proposing to change the policies to score quality measure performance using a percentile distribution, separated by decile categories and assign partial points based on the percentile distribution finalized in the CY 2017 Quality Payment Program final rule and codified at paragraphs (b)(1)(ix), (x), and (xi) of § 414.1380; however, we propose a technical correction to paragraph (ix) to clarify that measures are scored against measure benchmarks. We refer readers to the discussion at 81 FR 77286 for more details on those policies.

For illustration, Table 19 provides an example of assigning points for performance based on benchmarks using a percentile distribution, separated by decile categories. The example is of the benchmarks for Measure 130 Documentation of Current Medications in the Medical Record, which is based on our 2015 benchmark file for the 2017 MIPS performance period.

Table 19—Example of Assigning Points for Performance Based on a Benchmark, Separated by Deciles

Submission mechanismMeasure ID #130 (documentation of current medications in the medical record) *
Claims performance benchmarkEHR performance benchmarkRegistry/QCDR benchmark
Decile 1 or 2 (3 points)<96.11<76.59<61.27
Decile 3 (3.0-3.9 points)96.11-98.7376.59-87.8861.27-82.11
Decile 4 (4.0-4.9 points)98.74-99.6487.89-92.7382.12-91.71
Decile 5 (5.0-5.9 points)99.65-99.9992.74-95.3591.72-96.86
Start Printed Page 30102
Decile 6 (6.0-6.9 points)95.36 -97.0896.87-99.30
Decile 7 (7.0-7.9 points)97.09-98.2799.31 -99.99
Decile 8 (8.0-8.9 points)98.28-99.12
Decile 9 (9.0-9.9 points)99.13-99.75
Decile 10 (10 points)100>= 99.76100
* Based on our historical benchmark file for the 2017 MIPS performance period.

In Table 19, the cells with “—” represent where there is a cluster at the top of benchmark distribution. For example, for the claims benchmark, over 50 percent of the MIPS eligible clinicians submitting that measure had a performance rate of 100 percent based on 2015 PQRS data. Because of the cluster, clinicians who are at the 6, 7, 8, and 9th decile all would have performance rates of 100 percent and would all receive a score of 10 points, indicated by dashes for those deciles. Based on this clustered distribution, those clinicians with performance of 99.99 percent fall into decile 5 and receive points in the range from 5.0 to 5.9 points. For this measure, the benchmark for each submission mechanism is topped out.

We note that for quality measures for which baseline period data is available, we will publish the numerical baseline period benchmarks with deciles prior to the start of the performance period (or as soon as possible thereafter) (81 FR 77282). For quality measures for which there is no comparable data from the baseline period, we will publish the numerical performance period benchmarks after the end of the performance period (81 FR 77282). We will also publish further explanation of how we calculate partial points at qpp.cms.gov.

(i) Floor for Scored Quality Measures

For the 2017 MIPS performance period, we also finalized at § 414.1380(b)(1) a global 3-point floor for each scored quality measure, as well as for the hospital readmission measure (if applicable), such that MIPS eligible clinicians would receive between 3 and 10 measure achievement points for each submitted measure that can be reliably scored against a benchmark, which requires meeting the case minimum and data completeness requirements (81 FR 77286 through 77287). Likewise, for measures without a benchmark based on the baseline period, we stated that we would continue to assign between 3 and 10 measure achievement points for performance years after the first transition year because it would help to ensure that the MIPS eligible clinicians are protected from a poor performance score that they would not be able to anticipate (81 FR 77282; 81 FR 77287). For measures with benchmarks based on the baseline period, we stated the 3-point floor was for the transition year and that we would revisit the 3-point floor in future years (81 FR 77286 through 77287).

For the 2018 MIPS performance period, we propose to again apply a 3-point floor for each measure that can be reliably scored against a benchmark based on the baseline period, and to amend § 414.1380(b)(1) accordingly. We refer readers to section II.C.7.a.(2)(h)(ii) of this rule, for our proposal to score measures in the CMS Web Interface for the Quality Payment Program for which performance is below the 30th percentile. We will revisit the 3-point floor for such measures again in future rulemaking.

We invite public comment on this proposal to again apply this 3-point floor for quality measures that can be reliably scored against a baseline benchmark in the 2018 MIPS performance period.

(ii) Additional Policies for the CAHPS for MIPS Measure Score

In the CY 2017 Quality Payment Program final rule, we finalized a policy for the CAHPS for MIPS measure, such that each Summary Survey Measure (SSM) will have an individual benchmark, that we will score each SSM individually and compare it against the benchmark to establish the number of points, and the CAHPS score will be the average number of points across SSMs (81 FR 77284).

As described in section II.C.6.b.(3)(a)(iii) of this proposed rule, we are proposing to remove two SSMs from the CAHPS for MIPS survey, which would result in the collection of 10 SSMs in the CAHPS for MIPS survey. Eight of those 10 SSMs have had high reliability for scoring in prior years, or reliability is expected to improve for the revised version of the measure, and they also represent elements of patient experience for which we can measure the effect one practice has compared to other practices participating in MIPS. The “Health Status and Functional Status” SSM, however, assesses underlying characteristics of a group's patient population characteristics and is less of a reflection of patient experience of care with the group. Moreover, to the extent that health and functional status reflects experience with the practice, case-mix adjustment is not sufficient to separate how much of the score is due to patient experience versus due to aspects of the underlying health of patients. The “Access to Specialists” SSM has low reliability; historically it has had small sample sizes, and therefore, the majority of groups do not achieve adequate reliability, which means there is limited ability to distinguish between practices' performance.

For these reasons, we propose not to score the “Health Status and Functional Status” SSM and the “Access to Specialists” SSM beginning with the 2018 MIPS performance period. Despite not being suitable for scoring, both SSMs provide important information about patient care. Qualitative work suggests that “Access to Specialists” is a critical issue for Medicare FFS beneficiaries. The survey is also a useful tool for assessing beneficiaries' self-reported health status and functional status, even if this measure is not used for scoring practices' care experiences. Therefore, we believe that continued collection of the data for these two SSMs is appropriate even though we do not propose to score them.

Other than these two SSMs, we propose to score the remaining 8 SSMs because they have had high reliability for scoring in prior years, or reliability is expected to improve for the revised version of the measure, and they also Start Printed Page 30103represent elements of patient experience for which we can measure the effect one practice has compared to other practices participating in MIPS. Table 20 summarizes the proposed SSMs included in the CAHPS for MIPS survey and illustrates application of our proposal to score only 8 measures.

Table 20—Proposed SSM for CAHPS for MIPS Scoring

Summary survey measureProposed for inclusion in the CAHPS for MIPS survey?Proposed for inclusion in CAHPS for MIPS scoring?
Getting Timely Care, Appointments, and InformationYesYes.
How Well Providers CommunicateYesYes.
Patient's Rating of ProviderYesYes.
Health Promotion & EducationYesYes.
Shared Decision MakingYesYes.
Stewardship of Patient ResourcesYesYes.
Courteous and Helpful Office StaffYesYes.
Care CoordinationYesYes.
Health Status and Functional StatusYesNo.
Access to SpecialistsYesNo.

We invite comment on our proposal not to score the “Health Status and Functional Status” and “Access to Specialists” SSMs beginning with the 2018 MIPS performance period.

We note that in section II.C.6.g.(3)(b)(i)(A) of this proposed rule, we are proposing to add the CAHPS for ACOs survey as an available measure for calculating the MIPS APM score for the Shared Savings Program and Next Generation ACO Model. We refer readers participating in ACOs to section II.C.6.g.(3)(b) of this proposed rule for the CAHPS for ACOs scoring methodology.

(c) Identifying and Assigning Measure Achievement Points for Topped Out Measures

Section 1848(q)(3)(B) of the Act requires that, in establishing performance standards with respect to measures and activities, we consider, among other things, the opportunity for continued improvement. We finalized in the CY 2017 Quality Payment Program final rule that we would identify topped out process measures as those with a median performance rate of 95 percent or higher (81 FR 77286). For non-process measures we finalized a topped out definition similar to the definition used in the Hospital VBP Program: Truncated Coefficient of Variation is less than 0.10 and the 75th and 90th percentiles are within 2 standard errors (81 FR 77286). When a measure is topped out, a large majority of clinicians submitting the measure performs at or very near the top of the distribution; therefore, there is little or no room for the majority of MIPS eligible clinicians who submit the measure to improve. We understand that every measure we have identified as topped out may offer room for improvement for some MIPS eligible clinicians; however, we believe asking clinicians to submit measures that we have identified as topped out and measures for which they already excel is an unnecessary burden that does not add value or improve beneficiary outcomes.

Based on 2015 historic benchmark data,[8] approximately 45 percent of the quality measure benchmarks currently meet the definition of topped out, with some submission mechanisms having a higher percent of topped out measures than others. Approximately 70 percent of claims measures are topped out, 10 percent of EHR measures are topped out, and 45 percent of registry/QCDR measures are topped out.

In the CY 2017 Quality Payment Program final rule, we finalized that for the 2019 MIPS payment year, we would score topped out quality measures in the same manner as other measures (81 FR 77286). We finalized that we would not modify the benchmark methodology for topped out measures for the first year that the measure has been identified as topped out, but that we would modify the benchmark methodology for topped out measures beginning with the 2020 MIPS payment year, provided that it is the second year the measure has been identified as topped out. As described in detail later in this section, we are proposing a phased in approach to apply special scoring to topped out measures, beginning with the 2018 MIPS performance period (2020 MIPS payment year), rather than modifying the benchmark methodology for topped out measures as indicated in the CY 2017 Quality Payment Program final rule.

In the CY 2017 Quality Payment Program final rule, we sought comment on how topped out measures should be scored provided that it is the second year the measure has been identified as topped out (81 FR 77286). We suggested three possible options: (1) Score the measures using a mid-cluster approach; (2) remove topped out measures; or (3) apply a flat percentage in building the benchmarks for topped out measures. Flat percentages assign points based directly on the percentage of performance rather than by a percentile distribution by decile. Flat-rate would provide high scores to virtually all clinicians submitting the measure because performance rates tend to be high. Cluster-based benchmarks for topped out measures are based on a percentile distribution, but because many submitters are clustered at the top of performance, there can be large drops in points assigned for relatively small differences in performance. The current top of the cluster approach can result in many clinicians receiving 10 points. A mid-cluster approach would limit the maximum number of points a topped out measure can achieve based on how clustered the score are, and could still result in large drops, although less than with the top of the cluster approach, in points assigned for relatively small differences in performance. We also noted in the CY 2017 Quality Payment Program final rule that we anticipate removing topped out measures over time and sought comment on what point in time we should remove topped out measures from MIPS (81 FR 77286). The comments and our proposed policy for removing topped out measures are described in section II.C.6.c.(2) of this proposed rule.

In response to our request for comment in the CY 2017 Quality Payment Program final rule, a few Start Printed Page 30104commenters believed that we should not score topped out measures differently from other measures because commenters believed changing the scoring could reduce quality, add complexity to the program, and reduce incentives to participate in MIPS. Several commenters recommended that if we do score topped out measures differently, we use flat percentages rather than cluster-based benchmarks, with a few commenters noting that using flat percentages could help ensure those with high performance on a measure are not penalized as low performers and another noting that allowing high scorers to earn maximum or near maximum points is similar to the approach in the Shared Savings Program. A few commenters recommended that we publish information about topped out and potentially topped out measures prior to the performance period to allow clinicians time to adjust their reporting strategies, with one commenter noting that improvement may be rewarded in addition to achievement. One commenter recommended pushing back the baseline performance period for identifying topped out measures to the 2018 MIPS performance period because in the transition year it is unclear how many eligible clinicians will be reporting at different times and for what period they will report.

As described in section II.C.6.c.(2) of this proposed rule, we are proposing a lifecycle for topped out measures by which, after a measure benchmark is identified as topped out in the published benchmark for 2 years, in the third consecutive year it is identified as topped out it will be considered for removal through notice-and-comment rulemaking or the QCDR approval process and may be removed from the benchmark list in the fourth year, subject to the phased in approach described in section II.C.6.c.(2) of this proposed rule.

As part of the lifecycle for topped out measures, we also propose in this section II.C.7.a.(2)(c) of this proposed rule, a method to phase in special scoring for topped out measure benchmarks starting with the 2018 MIPS performance period, provided that is the second consecutive year the measure benchmark is identified as topped out in the benchmarks published for the performance period. This special scoring would not apply to measures in the CMS Web Interface, as explained later in this section. The phased-in approach described in this section represents our first step in methodically implementing special scoring for topped out measures.

We are not proposing to remove topped out measures for the 2018 MIPS performance period because we recognize that there are currently a large number of topped out measures and removing them may impact the ability of some MIPS eligible clinicians to submit 6 measures and may impact some specialties more than others. We note, however, that as described in section II.C.6.c.(2) of this proposed rule, we are proposing a timeline for removing topped out measures in future years. We believe this provides MIPS eligible clinicians the ability to anticipate and plan for the removal of specific topped out measures, while providing measure developers time to develop new measures.

We note that because we create a separate benchmark for each submission mechanism available for a measure, a benchmark for one submission mechanism for the measure may be identified as topped out while another submission mechanism's benchmark may not be topped out. The topped out designation and special scoring apply only to the specific benchmark that is topped out, not necessarily every benchmark for a measure. For example, the benchmark for the claims submission mechanism may be topped out for a measure, but the benchmark for the EHR submission mechanisms for that same measure may not be topped out. In this case, the topped out scoring would only apply to measures submitted via the claims submission mechanism, which has the topped out benchmark. We also describe in section II.C.6.c.(2) of this proposed rule that, similarly, only the submission mechanism that is topped out for the measure would be removed.

We propose to cap the score of topped out measures at 6 measure achievement points. We are proposing a 6-point cap for multiple reasons. First, we believe applying a cap to the current method of scoring a measure against a benchmark is a simple approach that can easily be predicted by clinicians. Second, the cap will create incentives for clinicians to submit other measures for which they can improve and earn future improvement points. Third, considering our proposed topped out measure lifecycle, we believe this cap would only be used for a few years and the simplicity of a cap on the current benchmarks would outweigh the cluster-based options or applying a cap on benchmarks based on flat-percentage, which are more complicated. The rationale for a 6-point cap is that 6 points is the median score for any measure as it represents the start of the 6th decile for performance and represents the spot between the bottom 5 deciles and start of the top 5 deciles.

We believe this proposed capped scoring methodology will incentivize MIPS eligible clinicians to begin submitting non-topped out measures without performing below the median score. This methodology also would not impact scoring for those MIPS eligible clinicians that do not perform near the top of the measure and therefore have significant room to improve on the measure. We may also consider lowering the cap below 6 points in future years, especially if we remove the 3-point floor for performance in future years.

We note that although we are proposing a new methodology for assigning measure achievement points for topped out measures, we are not changing the policy for awarding measure bonus points for topped out measures. Topped out measures will still be eligible for measure bonus points if they meet the required criteria. We refer readers to sections II.C.7.a.(2)(f) and II.C.7.a.(2)(g) of this proposed rule for more information about measure bonus points.

We request comments on our proposal to score topped out measures differently by applying a 6-point cap, provided it is the second consecutive year the measure is identified as topped out. Specifically, we seek feedback on whether 6 points is the appropriate cap or whether we should consider another value. We also seek comment on other possible options for scoring topped out measures that would meet our policy goals to encourage clinicians to begin to submit measures that are not topped out while also providing stability for MIPS eligible clinicians.

While we believe it is important to score topped out measures differently because they could have a disproportionate impact on the scores for certain MIPS eligible clinicians and topped out measures provide little room for improvement for the majority of MIPS eligible clinicians who submit them, we also recognize that numerous measure benchmarks are currently identified as topped out and special scoring for topped out measures could impact some specialties more than others. Therefore, we considered ways to phase in special scoring for topped out measures in a way that will begin to apply special scoring, but would not overwhelm any one specialty and would also provide additional time to evaluate the impact of topped out measures before implementing it for all topped out measures, while also beginning to encourage submission of measures that are not topped out.Start Printed Page 30105

We believe the best way to accomplish this is by applying special topped out scoring to a select number of measures for the 2018 performance period and to then apply the special topped out scoring to all topped out measures for the 2019 performance period, provided it is the second consecutive year the measure is topped out. We believe this approach allows us time to further evaluate the impact of topped out measures and allows for a methodical way to phase in topped out scoring.

We identified measures we believe should be scored with the special topped out scoring for the 2018 performance period by using the following set criteria, which are only intended as a way to phase in our topped-out measure policy for selected measures and are not intended to be criteria for use in future policies:

  • Measure is topped out and there is no difference in performance between decile 3 through decile 10. We applied this limitation because, based on historical data, there is no room for improvement for over 80 percent of MIPS eligible clinicians that reported on these measures.
  • Process measures only because we want to continue to encourage reporting on high priority outcome measures, and the small subset of structure measures was confined to only three specialties.
  • MIPS measures only (which does not include measures that can only be reported through a QCDR) given that QCDR measures go through a separate process for approval and because we want to encourage use of QCDRs required by section 1848(q)(1)(E) of the Act.
  • Measure is topped out for all mechanisms by which the measure can be submitted. Because we create a separate benchmark for each submission mechanism available for a measure, a benchmark for one submission mechanism for the measure may be identified as topped out while another submission mechanism's benchmark may not be topped out. For example, the benchmark for the claims submission mechanism may be topped out for a measure, but the benchmark for the EHR submission mechanisms for that same measure may not be topped out. We decided to limit our criteria to only measures that were topped out for all measures for simplicity and to avoid confusion about what scoring is applied to a measure.
  • Measure is in a specialty set with at least 10 measures, because 2 measures in the pathology specialty set, which only has 8 measures total would have been included.

Applying these criteria results in the 6 measures as listed in Table 21.

Table 21—Topped Out Measures Proposed for Special Scoring for the 2018 MIPS Performance Period

Measure nameMeasure IDMeasure typeTopped out for all submission mechanismsSpecialty set
Perioperative Care: Selection of Prophylactic Antibiotic—First OR Second Generation Cephalosporin21ProcessYesGeneral Surgery, Orthopedic Surgery, Otolaryngology, Thoracic Surgery, Plastic Surgery.
Melanoma: Overutilization of Imaging Studies in Melanoma224ProcessYesDermatology.
Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients)23ProcessYesGeneral Surgery, Orthopedic Surgery, Otolaryngology, Thoracic Surgery, Plastic Surgery.
Image Confirmation of Successful Excision of Image—Localized Breast Lesion262ProcessYesn/a.
Optimizing Patient Exposure to Ionizing Radiation: Utilization of a Standardized Nomenclature for Computerized Tomography (CT) Imaging Description359ProcessYesDiagnostic Radiology.
Chronic Obstructive Pulmonary Disease (COPD): Inhaled Bronchodilator Therapy52ProcessYesn/a.

We propose to apply the special topped out scoring method that we finalize for the 2018 performance period to only the 6 measures in Table 21 for the 2018 performance period, provided they are again identified as topped out in the benchmarks for the 2018 performance period. If these measures are not identified as topped out in the benchmarks published for the 2018 performance period, they will not be scored differently because they would not be topped out for a second consecutive year.

We seek comment on our proposal to apply special topped out scoring only to the 6 measures identified in Table 21 for the 2018 performance period.

Starting with the 2019 performance period, we propose to apply the special topped out scoring method to all topped out measures, provided it is the second (or more) consecutive year the measure is identified as topped out. We seek comment on our proposal to apply special topped out scoring to all topped out measures, provided it is the second (or more) consecutive year the measure is identified as topped out.

We illustrate the lifecycle for scoring and removing topped out measures based on our proposals as follows:

  • Year 1: Measure benchmarks are identified as topped out, which in this example would be in the benchmarks published for the 2017 MIPS performance period.
  • Year 2: Measure benchmarks are identified as topped out, which in this example would be in the benchmarks published for the 2018 MIPS performance period. Measures identified in Table 21 have special scoring applied, provided they are identified as topped out for the 2018 MIPS performance period, meaning it is the second consecutive year they are identified as topped out.
  • Year 3: Measure benchmarks are identified as topped out in the benchmarks published for the 2019 MIPS performance period. All measure benchmarks identified as topped out for the second (or more) consecutive year have special scoring applied for the 2019 MIPS performance period. In Year 3 we would also consider removal of the select set of topped out measures identified in Table 21, through notice and comment rulemaking, provided they are identified as topped out during the previous two (or more) consecutive Start Printed Page 30106years. In our example, Year 3 would be the 2019 performance period.
  • Year 4: Measure benchmarks are identified as topped out in the benchmarks published for the 2020 MIPS performance period. Measure benchmarks identified as topped out for a second (or more) consecutive year continue to have special scoring applied. Topped out measures finalized for removal for the 2020 MIPS performance period are no longer available for reporting.

An example of applying the proposed scoring cap compared to scoring applied for the 2017 MIPS performance period is provided in Table 22.

Table 22—Proposed Scoring for Topped Out Measures* Starting in the CY 2018 MIPS Performance Period Compared to the Transition Year Scoring

Scoring policyMeasure 1 (topped out)Measure 2 (topped out)Measure 3 (topped out)Measure 4 (topped out)Measure 5 (not topped out)Measure 6 (not topped out)Quality Cate-gory Percent Score *
2017 MIPS performance period Scoring10 measure achievement points10 measure achievement points10 measure achievement points4 measure achievement points (did not get max score)10 measure achievement points5 measure achievement points49/60 = 81.67%.
Proposed Capped Scoring applied6 measure achievement points6 measure achievement points6 measure achievement points4 measure achievement points10 measure achievement points5 measure achievement points37/60 = 61.67%.
NotesTopped out measures scored with 6-point measure achievement point cap. Cap does not impact score if the MIPS eligible clinician's score is below the cap.Still possible to earn maximum measure achievement points on the non-topped out measures.
* This example would only apply to the 6 measures identified in Table 21 for the CY 2018 MIPS Performance Period. This example also excludes bonus points and improvement scoring proposed in section II.C.7.a.(2)(i) of this proposed rule.

Together the proposed policies for phasing in capped scoring and removing topped out measures are intended to provide an incentive for MIPS eligible clinicians to begin to submit measures that are not topped out while also providing stability by allowing MIPS eligible clinicians who have few alternative measures to continue to receive standard scoring for most topped out measures for an additional year, and not perform below the median score for those 6 measures that receive special scoring. It also provides MIPS eligible clinicians the ability to anticipate and plan for the removal of specific topped out measures, while providing measure developers time to develop new measures.

We propose to add a new paragraph at § 414.1380(b)(1)(xiii) to codify our proposal for the lifecycle for removing topped out measures.

We also propose to add at § 414.1380(b)(1)(xiii)(A) that for the 2018 MIPS performance period, the 6 measures identified in Table 21 will receive a maximum of 6 measure achievement points, provided that the measure benchmarks are identified as topped out again in the benchmarks published for the 2018 MIPS performance period. We also propose to add at § 414.1380(b)(1)(xiii)(B) that beginning with the 2019 MIPS performance period, measure benchmarks, except for measures in the CMS Web Interface, that are identified as topped out for two 2 or more consecutive years will receive a maximum of 6 measure achievement points in the second consecutive year it is identified as topped out, and beyond. We specifically seek comment on whether the proposed policy to cap the score of topped out measures beginning with the 2019 performance period should apply to SSMs in the CAHPS for MIPS survey measure or whether there is another alternative policy that could be applied for the CAHPS for MIPS survey measure due to high, unvarying performance within the SSM. We note that we would like to encourage groups to report the CAHPS for MIPS survey as it incorporates beneficiary feedback.

We stated in the CY 2017 Quality Payment Program final rule that we do not believe it would be appropriate to remove topped out measures from the CMS Web Interface for the Quality Payment Program because the CMS Web Interface measures are used in MIPS and in APMs such as the Shared Savings Program and because we have aligned policies, where possible, with the Shared Savings Program, such as using the Shared Savings Program benchmarks for the CMS Web Interface measures (81 FR 77285). In the CY 2017 Quality Payment Program final rule, we also finalized that MIPS eligible clinicians submitting via the CMS Web Interface must submit all measures included in the CMS Web Interface (81 FR 77116). Thus, if a CMS Web Interface measure is topped out, the CMS Web Interface submitter cannot select other measures. Because of the lack of ability to select measures, we are not proposing to apply a special scoring adjustment to topped out measures for CMS Web Interface for the Quality Payment Program.

Additionally, because the Shared Savings Program incorporates a methodology for measures with high performance into the benchmark, we do not believe capping benchmarks from the CMS Web Interface for the Quality Payment Program is appropriate. We finalized in the CY 2017 Quality Payment Program final rule at § 414.1380(b)(1)(ii)(A) to use benchmarks from the corresponding reporting year of the Shared Savings Program. The Shared Savings Program adjusts some benchmarks to a flat percentage when the 60th percentile is equal to or greater than 80.00 percent for individual measures (78 FR 74759 through 74763), and, for other measures, benchmarks are set using flat percentages when the 90th percentile for a measure are equal to or greater than 95.00 percent (79 FR 67925). Thus, we are not proposing to apply the topped out measure cap to measures in the CMS Web Interface for the Quality Payment Program.

We seek comment on this proposal not to apply the topped out measure cap to measures in the CMS Web Interface for the Quality Payment Program.

(d) Case Minimum Requirements and Measure Reliability and Validity

To help ensure reliable measurement, in the CY 2017 Quality Payment Program final rule (81 FR 77288), we finalized a 20-case minimum for all quality measures except the all-cause hospital readmission measure. For the all-cause hospital readmission measure, we finalized in the CY 2017 Quality Payment Program final rule a 200-case minimum and finalized to apply the all-cause hospital readmission measure only to groups of 16 or more clinicians that meet the 200-case minimum requirement (81 FR 77288).Start Printed Page 30107

We are not proposing any changes to these policies.

For the 2019 MIPS payment year, we finalized in the CY 2017 Quality Payment Program final rule that if the measure is submitted but is unable to be scored because it does not meet the required case minimum, does not have a benchmark, or does not meet the data completeness requirement, the measure would receive a score of 3 points (81 FR 77288 through 77289). We identified two classes of measures for the transition year. Class [9] 1 measures are measures that can be scored based on performance because they have a benchmark, meet the case minimum requirement, and meet the data completeness standard. We finalized that Class 1 measures would receive 3 to 10 points based on performance compared to the benchmark (81 FR 77289). Class 2 measures are measures that cannot be scored based on performance because they do not have a benchmark, do not have at least 20 cases, or the submitted measure does not meet data completeness criteria. We finalized that Class 2 measures, which do not include measures submitted with the CMS Web Interface or administrative claims-based measures, receive 3 points (81 FR 77289).

We propose to maintain the policy to assign 3 points for measures that are submitted but do not meet the required case minimum or does not have a benchmark for the 2020 MIPS payment year and amend § 414.1380(b)(1)(vii) accordingly.

We also propose a change to the policy for scoring measures that do not meet the data completeness requirement for the 2020 MIPS payment year.

To encourage complete reporting, we are proposing that in the 2020 MIPS payment year, measures that do not meet data completeness standards will receive 1 point instead of the 3 points that were awarded in the 2019 MIPS payment year. We propose lowering the point floor to 1 for measures that do not meet data completeness standards for several reasons. First, we want to encourage complete reporting because data completeness is needed to reliably measure quality. Second, unlike case minimum and availability of a benchmark, data completeness is within the direct control of the MIPS eligible clinician. In the future, we intend that measures that do not meet the completeness criteria will receive zero points; however, we believe that during the second year of transitioning to MIPS, clinicians should continue to receive at least 1 measure achievement point for any submitted measure, even if the measure does not meet the data completeness standards.

We are concerned, however, that data completeness may be harder to achieve for small practices. For example, small practices tend to have small case volume and missing one or two cases could cause the MIPS eligible clinician to miss the data completeness standard as each case may represent multiple percentage points for data completeness. For example, for a small practice with only 20 cases for a measure, each case is worth 5 percentage points, and if they miss reporting just 11 or more cases, they would fail to meet the data completeness threshold, whereas for a practice with 200 cases, each case is worth 0.5 percentage points towards data completeness and the practice would have to miss more than 100 cases to fail to meet the data completeness criteria. Applying 1 point for missing data completeness based on missing a relatively small number of cases could disadvantage these clinicians, who may have additional burdens for reporting in MIPS, although we also recognize that failing to report on 10 or more patients is undesirable. In addition, we know that many small practices may have less experience with submitting quality performance category data and may not yet have systems in place to ensure they can meet the data completeness criteria. Thus, we are also proposing an exception to the proposed policy for measures submitted by small practices, as defined in § 414.1305. We propose that these clinicians would continue to receive 3 points for measures that do not meet data completeness.

Therefore, we propose to revise Class 2 measures to include only measures that cannot be scored based on performance because they do not have a benchmark or do not have at least 20 cases. We also propose to create Class 3 measures, which are measures that do not meet the data completeness requirement. We propose that the revised Class 2 measure would continue to receive 3 points. The proposed Class 3 measures would receive 1 point, except if the measure is submitted by a small practice in which case the Class 3 measure would receive 3 points. However, consistent with the policy finalized in the CY 2017 Quality Payment Program final rule, these policies for Class 2 and Class 3 measures would not apply to measures submitted with the CMS Web Interface or administrative claims-based measures. A summary of the proposals is provided in Table 23.

Table 23—Quality Performance Category: Scoring Measures Based on Performance

Measure typeDescription in transition yearScoring rules in 2017 MIPS performance periodDescription proposed for 2018 MIPS performance periodProposed for 2018 MIPS performance period
Class 1Measures that can be scored based on performance. Measures that were submitted or calculated that met the following criteria:3 to 10 points based on performance compared to the benchmarkSame as transition yearSame as transition year. 3 to 10 points based on performance compared to the benchmark.
(1) The measure has a benchmark;
(2) Has at least 20 cases; and
(3) Meets the data completeness standard (generally 50 percent.)
Start Printed Page 30108
Class 2Measures that cannot be scored based on performance. Measures that were submitted, but fail to meet one of the Class 1 criteria. The measure either3 points * This Class 2 measure policy does not apply to CMS Web Interface measures and administrative claims based measuresMeasures that were submitted and meet data completeness, but does not have one or both of the following: (1) a benchmark (2) at least 20 cases3 points *This Class 2 measure policy would not apply to CMS Web Interface measures and administrative claims based measures.
(1) does not have a benchmark,
(2) does not have at least 20 cases, or
(3) does not meet data completeness criteria.
Class 3n/an/aMeasures that were submitted, but do not meet data completeness criteria, regardless of whether they have a benchmark or meet the case minimum1 point except for small practices, which would receive 3 points. *This Class 3 measure policy would not apply to CMS Web Interface measures and administrative claims based measures.

We propose to amend § 414.1380(b)(1)(vii) to assign 3 points for measures that do not meet the case minimum or do not have a benchmark in the 2020 MIPS payment year, and to assign 1 point for measures that do not meet data completeness requirements, unless the measure is submitted by a small practice, in which case it would receive 3 points.

We invite comment on our proposal to assign 1 point to measures that do not meet data completeness criteria, with an exception for measures submitted by small practices.

We are not proposing to change the methodology we use to score measures submitted via the CMS Web Interface that do not meet the case minimum, do not have a benchmark, or do not meet the data completeness requirement finalized in the CY 2017 Quality Payment Program final rule and codified at paragraph (b)(1)(viii) of § 414.1380. However, we note that as described in section II.C.7.a.(2)(h)(ii) of this proposed rule, we are proposing to add that CMS Web Interface measures with a benchmark that are redesignated from pay for performance to pay for reporting by the Shared Savings Program will not be scored. We refer readers to the discussion at 81 FR 77288 for more details on our previously finalized policy.

We are also not proposing any changes to the policy to not include administrative claims measures in the quality performance category percent score if the case minimum is not met or if the measure does not have a benchmark finalized in the CY 2017 Quality Payment Program final rule and codified at paragraph (b)(1)(viii) of § 414.1380. We refer readers to the discussion at 81 FR 77288 for more details on that policy.

To clarify the exclusion of measures submitted via the CMS Web Interface and based on administrative claims from the policy changes proposed to be codified at paragraph (b)(1)(vii) previously, we are amending paragraph (b)(1)(vii) to make it subject to paragraph (b)(1)(viii), which codifies the exclusion.

(e) Scoring for MIPS Eligible Clinician That Do Not Meet Quality Performance Category Criteria

In the CY 2017 Quality Payment Program final rule, we finalized that MIPS eligible clinicians who fail to submit a measure that is required to satisfy the quality performance category submission criteria would receive zero points for that measure (81 FR 77291). For each required measure that is not submitted, a MIPS eligible clinician would receive zero points out of 10. For example, if a MIPS eligible clinician had 6 measures available and applicable but submitted only 4 measures, the MIPS eligible clinician would be assigned zero out of 10 measure achievement points for the 2 missing measures, which would be calculated into their performance category percent score.

We are not proposing any changes to the policy to assign zero points for failing to submit a measure that is required in this proposed rule.

In the CY 2017 Quality Payment Program final rule, we also finalized implementation of a validation process for claims and registry submissions to validate whether MIPS eligible clinicians have 6 applicable and available measures, whether an outcome measure is available or whether another high priority measure is available if an outcome measure is not available (81 FR 77290 through 77291).

We are not proposing any changes to apply a process to validate whether MIPS eligible clinicians that submit measures via claims and registry submissions have measures available and applicable. As stated in the CY 2017 Quality Payment Program final rule (81 FR 77290), we did not intend to establish a validation process for QCDRs because we expect that MIPS eligible clinicians that enroll in QCDRs will have sufficient meaningful measures to meet the quality performance category criteria (81 FR 77290 through 77291). We do not propose any changes to this policy.

We also stated that if a MIPS eligible clinician did not have 6 measures relevant within their EHR to meet the full specialty set requirements or meet the requirement to submit 6 measures, the MIPS eligible clinician should select a different submission mechanism to meet the quality performance category requirements and should work with their EHR vendors to incorporate applicable measures as feasible (81 FR 77290 through 77291). Under our proposals in section II.C.6.a.(1) of this proposed rule to allow measures to be submitted and scored via multiple mechanisms within a performance category, we anticipate that MIPS Start Printed Page 30109eligible clinicians that submit fewer than 6 measures via EHR will have sufficient additional measures available via a combination of submission mechanisms to submit the measures required to meet the quality performance category criteria. For example, the MIPS eligible clinician could submit 2 measures via EHR and supplement that with 4 measures via QCDR or registry.

Therefore, given our proposal to score multiple mechanisms, if a MIPS eligible clinician submits any quality measures via EHR or QCDR, we would not conduct a validation process because we expect these MIPS eligible clinicians to have sufficient measures available to meet the quality performance category requirements.

Given our proposal in section II.C.7.a.(2)(h) of this proposed rule to score measures submitted via multiple mechanisms, we propose to validate the availability and applicability of measures only if a MIPS eligible clinician submits via claims submission options only, registry submission options only, or a combination of claims and registry submission options. In these cases, we propose that we will apply the validation process to determine if other measures are available and applicable broadly across claims and registry submission options. We will not check if there are measures available via EHR or QCDR submission options for these reporters. We note that groups cannot report via claims and therefore groups and virtual groups will only have validation applied across registries. We would validate the availability and applicability of a measure through a clinically related measure analysis based on patient type, procedure, or clinical action associated with the measure specifications. For us to recognize fewer than 6 measures, an individual MIPS eligible clinician must submit exclusively using claims or qualified registries or a combination of the two, and a group or virtual group must submit exclusively using qualified registries. Given our proposal in section II.C.7.a.(2)(h) of this proposed rule to score measures submitted via multiple mechanisms, validation will be conducted first by applying the clinically related measure analysis for the individual measure and then, to the extent technically feasible, validation will be applied to check for available measures available via both claims and registries.

We recognize that in extremely rare instances there may be a MIPS eligible clinician who may not have available and applicable quality measures. For example, a subspecialist who focuses on a very targeted clinical area may not have any measures available. However, in many cases, the clinician may be part of a broader group or would have the ability to select some of the cross-cutting measures that are available. Given the wide array of submission options, including QCDRs which have the flexibility to develop additional measures, we believe this scenario should be extremely rare. If we are not able to score the quality performance category, we may reweight their score according to the reweighting policies described in section II.C.7.b.(3)(b) and II.C.7.b.(3)(d) of this proposed rule. We note that we anticipate this will be a rare circumstance given our proposals to allow measures to be submitted and scored via multiple mechanisms within a performance category and to allow facility-based measurement for the quality performance category.

(f) Incentives To Report High Priority Measures

In the CY 2017 Quality Payment Program final rule, we finalized that we would award 2 bonus points for each outcome or patient experience measure and 1 bonus point for each additional high priority measure that is reported in addition to the 1 high priority measure that is already required to be reported under the quality performance category submission criteria, provided the measure has a performance rate greater than zero, and the measure meets the case minimum and data completeness requirements (81 FR 77293). High priority measures were defined as outcome, appropriate use, patient safety, efficiency, patient experience and care coordination measures, as identified in Tables A and E in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77558 and 77686). We also finalized that we will apply measure bonus points for the CMS Web Interface for the Quality Payment Program based on the finalized set of measures reportable through that submission mechanism (81 FR 77293). We note that in addition to the 14 required measures, CMS Web Interface reporters may also report the CAHPS for MIPS survey and receive measure bonus points for submitting that measure.

We are not proposing any changes to these policies for awarding measure bonus points for reporting high priority measures in this proposed rule.

In the CY 2017 Quality Payment Program final rule, we finalized a cap on high priority measure bonus points at 10 percent of the denominator (total possible measure achievement points the MIPS eligible clinician could receive in the quality performance category) of the quality performance category for the first 2 years of MIPS (81 FR 77294). Groups that submit via the CMS Web Interface for the Quality Payment Program are also subject to the 10 percent cap on high priority measure bonus points. We are not proposing any changes to the cap on measure bonus points for reporting high priority measures, which is codified at § 414.1380(b)(1)(xiv)(D) [10] , in this proposed rule.

(g) Incentives to Use CEHRT To Support Quality Performance Category Submissions

Section 1848(q)(5)(B)(ii) of the Act outlines specific scoring rules to encourage the use of CEHRT under the quality performance category. For more of the statutory background and description of the proposed and finalized policies, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77294 through 77299).

In the CY 2017 Quality Payment Program final rule at § 414.1380(b)(1)(xiv), we codified that 1 bonus point is available for each quality measure submitted with end-to-end electronic reporting, under certain criteria described below (81 FR 77297). We also finalized a policy capping the number of bonus points available for electronic end-to-end reporting at 10 percent of the denominator of the quality performance category percent score, for the first 2 years of the program (81 FR 77297). For example, when the denominator is 60, the number of measure bonus points will be capped at 6 points. We also finalized that the CEHRT bonus would be available to all submission mechanisms except claims submissions. Specifically, MIPS eligible clinicians who report via qualified registries, QCDRs, EHR submission mechanisms, or the CMS Web Interface for the Quality Payment Program, in a manner that meets the end-to-end reporting requirements, may receive 1 bonus point for each reported measure with a cap as described (81 FR 77297).

We are not proposing changes to these policies related to bonus points for using CEHRT for end-to-end reporting in this proposed rule. However, we are seeking comment on the use of health IT in quality measurement and how HHS can encourage the use of certified EHR technology in quality measurement as established in the statute. What other incentives within this category for reporting in an end-to-end manner could be leveraged to incentivize more clinicians to report electronically? What format should these incentives take? For Start Printed Page 30110example, should clinicians who report all of their quality performance category data in an end-to-end manner receive additional bonus points than those who report only partial electronic data? Are there other ways that HHS should incentivize providers to report electronic quality data beyond what is currently employed? We welcome public comment on these questions.

(h) Calculating Total Measure Achievement and Measure Bonus Points

In section II.C.7.a.(2)(i) of this proposed rule, we are proposing a new methodology to reward improvement based on achievement, from 1 year to another, which requires modifying the calculation of the quality performance category percent score. In this section II.C.7.a.(2)(h) of the proposed rule, we are summarizing the policies for calculating the total measure achievement points and total measure bonus points, prior to scoring improvement and the final quality performance category percent score. We note that we will refer to policies finalized in the CY 2017 Quality Payment Program final rule that apply to the quality performance category score, which is referred to as the quality performance category percent score in this proposed rule, in this section. We are also proposing some refinements to address the ability for MIPS eligible clinicians to submit quality data via multiple submission mechanisms.

(i) Calculating Total Measure Achievement and Measure Bonus Points for Non-CMS Web Interface Reporters

In the CY 2017 Quality Payment Program final rule (81 FR 77300), we finalized that if a MIPS eligible clinician elects to report more than the minimum number of measures to meet the MIPS quality performance category criteria, then we will only include the scores for the measures with the highest number of assigned points, once the first outcome measure is scored, or if an outcome measure is not available, once another high priority measure is scored. We are not proposing any changes to the policy to score the measures with the highest number of assigned points in this proposed rule; however, we are proposing refinements to account for measures being submitted across multiple submission mechanisms.

In the CY 2017 Quality Payment Program final rule, we sought comment on whether to score measures submitted across multiple submission mechanisms (81 FR 77275). As described in section II.C.6.a.(1) of this proposed rule, we are proposing that MIPS eligible clinicians be able to submit measures within a performance category via multiple submission mechanisms. In the CY 2017 Quality Payment Program final rule, we also sought comment on what approach we should use to combine the scores for quality measures from multiple submission mechanisms into a single aggregate score for the quality performance category (81 FR 77275). Examples of possible scoring options were a weighted average score on quality measures submitted through two or more different mechanisms or taking the highest scores for any submitted measure regardless of how the measure is submitted. A few comments received in response to the CY 2017 Quality Payment Program final rule did not support developing different weights for different submission methods. One commenter recommended that we take the highest score for any submitted measure, regardless of submission mechanisms, or alternatively, calculate independent scores that would each contribute equally to the final score.

After consideration of the comments we received, we are proposing, beginning with the 2018 MIPS performance period, a method to score quality measures if a MIPS eligible clinician submits measures via more than one of the following submission mechanisms: Claims, qualified registry, EHR or QCDR submission options. We believe that allowing MIPS eligible clinicians to be scored across these data submission mechanisms in the quality performance category will provide additional options for MIPS eligible clinicians to report the measures required to meet the quality performance category criteria, and encourage MIPS eligible clinicians to begin using electronic submission mechanisms, even if they may not have 6 measures to report via a single electronic submission mechanism alone. We note that we also continue to score the CMS-approved survey vendor for CAHPS for MIPS submission options in conjunction with other submission mechanisms (81 FR 77275) as noted in Table 24.

We propose to score measures across multiple mechanisms using the following rules:

  • As with the rest of MIPS, we will only score measures within a single identifier. For example, as codified in § 414.1310(e), eligible clinicians and MIPS eligible clinicians within a group aggregate their performance data across the TIN in order for their performance to be assessed as a group. Therefore, measures can only be scored across multiple mechanisms if reported by the same individual MIPS eligible clinician, group, virtual group or APM Entity, as described in Table 24.
  • We do not propose to aggregate measure results across different submitters to create a single score for an individual measure (for example, we are not going to aggregate scores from different TINs within a virtual group TIN to create a single virtual group score for the measures; rather, virtual groups must perform that aggregation across TINs prior to data submission to CMS). Virtual groups are treated like other groups and must report all of their measures at the virtual group level, for the measures to be scored. Data completeness and all the other criteria will be evaluated at the virtual group level. Then the same rules apply for selecting which measures are used for scoring. In other words, if a virtual group representative submits some measures via a qualified registry and other measures via EHR, but an individual TIN within the virtual group also submits measures, we will only use the scores from the measures that were submitted at the virtual group level, because the TIN submission does not use the virtual group identifier. This is consistent with our other scoring principles, where, for virtual groups, all quality measures are scored at the virtual group level.
  • Separately, as also described in Table 24, because CMS Web Interface and facility-based measurement each have a comprehensive set of measures that meet the proposed MIPS submission requirements, we do not propose to combine CMS Web Interface measures or facility-based measurement with other group submission mechanisms (other than CAHPS for MIPS, which can be submitted in conjunction with the CMS Web Interface). We refer readers to section II.C.7.a.(2)(h)(ii) of this proposed rule for discussion of calculating the total measure achievement and measure bonus points for CMS Web Interface reporters and to section II.C.7.a.(4) of this proposed rule for a description of our proposed policies on facility-based measurement. We list these submission mechanisms in Table 24, to illustrate that CMS Web Interface submissions and facility-based measurement cannot be combined with other submission options, except that the CAHPS for MIPS survey can be combined with CMS Web Interface, as described in section II.C.7.a.(2)(h)(ii) of this proposed rule.Start Printed Page 30111

Table 24—Scoring Allowed Across Multiple Mechanisms by Submission Mechanism

[Determined by MIPS identifier and submission mechanism]

MIPS identifier and submission mechanismsWhen can quality measures be scored across multiple mechanisms?
Individual eligible clinician reporting via claims, EHR, QCDR, and registry submission optionsCan combine claims, EHR, QCDR, and registry.
Group reporting via EHR, QCDR, registry, and the CAHPS for MIPS surveyCan combine EHR, QCDR, registry, and CAHPS for MIPS survey.
Virtual group reporting via EHR, QCDR, registry, and the CAHPS for MIPS surveyCan combine EHR, QCDR, registry, and CAHPS for MIPS survey.
Group reporting via CMS Web InterfaceCannot be combined with other submission mechanisms, except for the CAHPS for MIPS survey.
Virtual group reporting via CMS Web InterfaceCannot be combined with other submission mechanisms, except for the CAHPS for MIPS survey.
Individual or group reporting facility-based measuresCannot be combined with other submission mechanisms.
MIPS APMs reporting Web Interface or other quality measuresMIPS APMs are subject to separate scoring standards and cannot be combined with other submission mechanisms.
  • If a MIPS eligible clinician submits the same measure via 2 different submission mechanisms, we will score each mechanism by which the measure is submitted for achievement and take the highest measure achievement points of the 2 mechanisms.
  • Measure bonus points for high priority measures would be added for all measures submitted via all the different submission mechanisms available, even if more than 6 measures are submitted, but high priority measure bonus points are only available once for each unique measure (as noted by the measure number) that meets the criteria for earning the bonus point. For example, if a MIPS eligible clinician submits 8 measures—6 process and 2 outcome—and both outcome measures meet the criteria for a high priority bonus (meeting the required data completeness, case minimum, and has a performance rate greater than zero), the outcome measure with the highest measure achievement points would be scored as the required outcome measure and then the measures with the next 5 highest measure achievement points will contribute to the final quality score. This could include the second outcome measure but does not have to. Even if the measure achievement points for the second outcome measure are not part of the quality performance category percent score, measure bonus points would still be available for submitting a second outcome measure and meeting the requirement for the high priority measure bonus points. The rationale for providing measure bonus points for measures that do not contribute measure achievement points to the quality performance category percent score is that it would help create better benchmarks for outcome and other high priority measures by encouraging clinicians to report them even if they may not have high performance on the measure. We also want to encourage MIPS eligible clinicians to submit to us all of their available MIPS data, not only the data that they or their intermediary deem to be their best data. We believe it will be in the best interest of all MIPS eligible clinicians that we determine which measures will result in the clinician receiving the highest MIPS score. If the same measure is submitted through multiple submission mechanisms, we would apply the bonus points only once to the measure. We propose to amend § 414.1380(b)(1)(xiv) (as redesignated from § 414.1380(b)(1)(xiii)) to add paragraph (b)(1)(xiv)(E) that if the same high priority measure is submitted via two or more submission mechanisms, as determined using the measure ID, the measure will receive high priority measure bonus points only once for the measure. The total measure bonus points for high-priority measures would still be capped at 10 percent of the total possible measure achievement points.
  • Measure bonus points that are available for the use of end-to-end electronic reporting would be calculated for all submitted measures across all submission mechanisms, including measures that cannot be reliably scored against a benchmark. If the same measure is submitted through multiple submission mechanisms, then we would apply the bonus points only once to the measure. For example, if the same measure is submitted using end-to-end reporting via both a QCDR and EHR reporting mechanism, the measure would only get a measure bonus point one time. We propose to amend § 414.1380(b)(1)(xv) (as redesignated) to add that if the same measure is submitted via two or more submission mechanisms, as determined using the measure ID, the measure will receive measure bonus points only once for the measure. The total measure bonus points for end-to-end electronic reporting would still be capped at 10 percent of the total available measure achievement points.

Although we provide a po