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Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models

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AGENCY:

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

ACTION:

Final rule with comment period.

SUMMARY:

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new approach to payment called the Quality Payment Program that rewards the delivery of high-quality patient care through two avenues: Advanced Alternative Payment Models (Advanced APMs) and the Merit-based Incentive Payment System (MIPS) for eligible clinicians or groups under the PFS. This final rule with comment period establishes incentives for participation in certain alternative payment models (APMs) and includes the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models (PFPMs). Alternative Payment Models are payment approaches, developed in partnership with the clinician community, that provide added incentives to deliver high-quality and cost-efficient care. APMs can apply to a specific clinical condition, a care episode, or a population. This final rule with comment period also establishes the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS will consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and will continue the focus on quality, cost, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. In this final rule with comment period we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that will be more easily identified and understood by our stakeholders.

DATES:

Effective date: The provisions of this final rule with comment period are effective on January 1, 2017.

Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 19, 2016.

ADDRESSES:

In commenting, please refer to file code CMS-5517-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed):

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

2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5517-FC, P.O. Box 8013, Baltimore, MD 21244-8013.

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

3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5517-FC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

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

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

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

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

If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.

Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Molly MacHarris, (410) 786-4461, for inquiries related to MIPS. James P. Sharp, (410) 786-7388, for inquiries related to APMs.

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SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

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

A. Establishing MIPS and the Advanced APM Incentive

B. Program Principles and Goals

C. Changes to Existing Programs

D. Definitions

E. MIPS Program Details

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

III. Collection of Information Requirements

IV. Regulatory Impact Analysis

A. Statement of Need

B. Overall Impact

C. Changes in Medicare Payments

D. Impact on Beneficiaries

E. Impact on Other Health Care Programs and Providers

F. Alternatives Considered

G. Assumptions and Limitations

H. Accounting Statement

Acronyms

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

ABCTM Achievable Benchmark of Care

ACO Accountable Care Organization

APM Alternative Payment Model

APRN Advanced Practice Registered Nurse

ASPE HHS' Office of the Assistant Secretary for Planning and Evaluation

BPCI Bundled Payments for Care Improvement

CAH Critical Access Hospital

CAHPS Consumer Assessment of Healthcare Providers and Systems

CBSA Non-Core Based Statistical Area

CDS Clinical Decision Support

CEHRT Certified EHR technology

CFR Code of Federal Regulations

CHIP Children's Health Insurance Program

CJR Comprehensive Care for Joint Replacement

CMMI Center for Medicare & Medicaid Innovation (CMS Innovation Center)

COI Collection of InformationStart Printed Page 77009

CPIA Clinical Practice Improvement Activity

CPOE Computerized Provider Order Entry

CPR Customary, Prevailing, and Reasonable

CPS Composite Performance Score

CPT Current Procedural Terminology

CQM Clinical Quality Measure

CY Calendar Year

eCQM electronic Clinician Quality Measure

ED Emergency Department

EHR Electronic Health Record

EP Eligible Professional

ESRD End-Stage Renal Disease

FFS Fee-for-Service

FR Federal Register

FQHC Federally Qualified Health Center

GAO Government Accountability Office

HIE Health Information Exchange

HIPAA Health Insurance Portability and Accountability Act of 1996

HITECH Health Information Technology for Economic and Clinical Health

HPSA Health Professional Shortage Area

HHS Department of Health & Human Services

HRSA Health Resources and Services Administration

IHS Indian Health Service

IT Information Technology

LDO Large Dialysis Organization

MACRA Medicare Access and CHIP Reauthorization Act of 2015

MEI Medicare Economic Index

MIPAA Medicare Improvements for Patients and Providers Act of 2008

MIPS Merit-based Incentive Payment System

MLR Minimum Loss Rate

MSPB Medicare Spending per Beneficiary

MSR Minimum Savings Rate

MUA Medically Underserved Area

NPI National Provider Identifier

OCM Oncology Care Model

ONC Office of the National Coordinator for Health Information Technology

PECOS Medicare Provider Enrollment, Chain, and Ownership System

PFPMs Physician-Focused Payment Models

PFS Physician Fee Schedule

PHS Public Health Service

PQRS Physician Quality Reporting System

PTAC Physician-Focused Payment Model Technical Advisory Committee

QCDR Qualified Clinical Data Registry

QP Qualifying APM Participant

QRDA Quality Reporting Document Architecture

QRUR Quality and Cost Reports

RBRVS Resource-Based Relative Value Scale

RFI Request for Information

RHC Rural Health Clinic

RIA Regulatory Impact Analysis

RVU Relative Value Unit

SGR Sustainable Growth Rate

TCPI Transforming Clinical Practice Initiative

TIN Tax Identification Number

VM Value-Based Payment Modifier

VPS Volume Performance Standard

I. Executive Summary

1. Overview

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015), amended title XVIII of the Social Security Act (the Act) to repeal the Medicare sustainable growth rate, to reauthorize the Children's Health Insurance Program, and to strengthen Medicare access by improving physician and other clinician payments and making other improvements. This rule finalizes policies to improve physician and other clinician payments by changing the way Medicare incorporates quality measurement into payments and by developing new policies to address and incentivize participation in Alternative Payment Models (APMs). These unified policies to promote greater value within the healthcare system are referred to as the Quality Payment Program.

The MACRA, landmark bipartisan legislation, advances a forward-looking, coordinated framework for health care providers to successfully take part in the CMS Quality Payment Program that rewards value and outcomes in one of two ways:

  • Advanced Alternative Payment Models (Advanced APMs).
  • Merit-based Incentive Payment System (MIPS).

The MACRA marks a milestone in efforts to improve and reform the health care system. Building off of the successful coverage expansions and improvements to access under the Patient Protection and Affordable Care Act (Affordable Care Act), the MACRA puts an increased focus on the quality and value of care delivered. By implementing MACRA to promote participation in certain APMs, such as the Shared Saving Program, Medical Home Models, and innovative episode payment models for cardiac and joint care, and by paying eligible clinicians for quality and value under MIPS, we support the nation's progress toward achieving a patient-centered health care system that delivers better care, smarter spending, and healthier people and communities. By driving significant changes in how care is delivered to make the health care system more responsive to patients and families, we believe the Quality Payment Program supports eligible clinicians in improving the health of their patients, including encouraging interested eligible clinicians in their successful transition into APMs. To implement this vision, we are finalizing a program that emphasizes high-quality care and patient outcomes while minimizing burden on eligible clinicians and that is flexible, highly transparent, and improves over time with input from clinical practices. To aid in this process, we have sought feedback from the health care community through various public avenues and solicited comment through the proposed rule. As we establish policies for effective implementation of the MACRA, we do so with the explicit understanding that technology, infrastructure, physician support systems, and clinical practices will change over the next few years. In addition, we are aware of the diversity of clinician practices in their experience with quality-based payments. As a result of these factors, we expect the Quality Payment Program to evolve over multiple years in order to achieve our national goals. In the early years of the program, we will begin by laying the groundwork for expansion towards an innovative, outcome-focused, patient-centered, resource-effective health system. Through a staged approach, we can develop policies that are operationally feasible and made in consideration of system capabilities and our core strategies to drive progress and reform efforts. Thus, due to this staged approach, we are finalizing the rule with a comment period. We commit to continue iterating on these policies.

The Quality Payment Program aims to do the following: (1) Support care improvement by focusing on better outcomes for patients, decreased provider burden, and preservation of independent clinical practice; (2) promote adoption of alternative payment models that align incentives across healthcare stakeholders; and (3) advance existing efforts of Delivery System Reform, including ensuring a smooth transition to a new system that promotes high-quality, efficient care through unification of CMS legacy programs.

This final rule with comment period establishes the Quality Payment Program and its two interrelated pathways: Advanced APMs and the MIPS. This final rule with comment period establishes incentives for participation in Advanced APMs, supporting the Administration's goals of transitioning from fee-for-service (FFS) payments to payments for quality and value, including approaches that focus on better care, smarter spending, and healthier people. This final rule with comment period also includes definitions of Qualifying APM Participants (QPs) in Advanced APMs and outlines the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations to the Secretary on physician-focused payment models (PFPMs).

MIPS is a new program for certain Medicare-participating eligible Start Printed Page 77010clinicians that will make payment adjustments based on performance on quality, cost and other measures, and will consolidate components of three existing programs—the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for eligible professionals (EPs). As prescribed by Congress, MIPS will focus on: Quality—both a set of evidence-based, specialty-specific standards as well as practice-based improvement activities; cost; and use of certified electronic health record (EHR) technology (CEHRT) to support interoperability and advanced quality objectives in a single, cohesive program that avoids redundancies. Many features of MIPS are intended to simplify and integrate further during the second and third years.

2. Quality Payment Program Strategic Objectives

We solicited and reviewed over 4000 comments and had over 100,000 physicians and other stakeholders attend our outreach sessions. Through this outreach, we created six strategic objectives to drive continued progress and improvement.

These objectives guided our final policies and will guide our future rulemaking in order to design, implement and evolve a Quality Payment Program that aims to improve health outcomes, promote smarter spending, minimize burden of participation, and provide fairness and transparency in operations. These strategic objectives are as follows: (1) To improve beneficiary outcomes and engage patients through patient-centered Advanced APM and MIPS policies; (2) to enhance clinician experience through flexible and transparent program design and interactions with easy-to-use program tools; (3) to increase the availability and adoption of robust Advanced APMs; (4) to promote program understanding and maximize participation through customized communication, education, outreach and support that meet the needs of the diversity of physician practices and patients, especially the unique needs of small practices; (5) to improve data and information sharing to provide accurate, timely, and actionable feedback to clinicians and other stakeholders; and (6) to ensure operational excellence in program implementation and ongoing development. More information on these objectives and the Quality Payment Program can be found at QualityPaymentProgram.cms.gov.

With these objectives we recognize that the Quality Payment Program provides new opportunities to improve care delivery by supporting and rewarding clinicians as they find new ways to engage patients, families and caregivers and to improve care coordination and population health management. In addition, we recognize that by developing a program that is flexible instead of one-size-fits-all, clinicians will be able to choose to participate in a way that is best for them, their practice, and their patients. For clinicians interested in APMs, we believe that by setting ambitious yet achievable goals, eligible clinicians will move with greater certainty toward these new approaches of delivering care. To these ends, and to ensure this program works for all stakeholders, we further recognize that we must provide ongoing education, support, and technical assistance so that clinicians can understand program requirements, use available tools to enhance their practices, and improve quality and progress toward participation in alternative payment models if that is the best choice for their practice. Finally, we understand that we must achieve excellence in program management, focusing on customer needs, promoting problem-solving, teamwork, and leadership to provide continuous improvements in the Quality Payment Program.

3. One Quality Payment Program

Clinicians have told us that they do not separate their patient care into domains, and that the Quality Payment Program needs to reflect typical clinical workflows in order to achieve its goals of better patient care. Advanced APMs, the focus of one pathway of the Quality Payment Program, contribute to better care and smarter spending by allowing physicians and other clinicians to deliver coordinated, customized, high-quality care to their patients within a streamlined payment system. Within MIPS, the second pathway of the Quality Payment Program, we believe that the unification into one Quality Payment Program can best be accomplished by making connections across the four pillars of the MIPS payment structure identified in the MACRA legislation—quality, clinical practice improvement activities (referred to as “improvement activities”), meaningful use of CEHRT (referred to as “advancing care information”), and resource use (referred to as “cost”)—and by emphasizing that the Quality Payment Program is at its core about improving the quality of patient care. Indeed, the bedrock of the Quality Payment Program is high-quality, patient-centered care followed by useful feedback, in a continuous cycle of improvement. The principal way MIPS measures quality of care is through evidence-based clinical quality measures (CQMs) which MIPS eligible clinicians can select, the vast majority of which are created by or supported by clinical leaders and endorsed by a consensus-based process. Over time, the portfolio of quality measures will grow and develop, driving towards outcomes that are of the greatest importance to patients and clinicians. Through MIPS, we have the opportunity to measure quality not only through clinician-proposed measures, but to take it a step further by also accounting for activities that physicians themselves identify: Namely, practice-driven quality improvement. The MACRA requires us to measure whether technology is used meaningfully. Based on significant feedback, this area is simplified into supporting the exchange of patient information and how technology specifically supports the quality goals selected by the practice. The cost performance category has also been simplified and weighted at zero percent of the final score for the transition year of CY 2017. Given the primary focus on quality, we have accordingly indicated our intention to align these measures fully to the quality measures over time in the scoring system (see section II.E.6.a. for further details). That is, we are establishing special policies for the first year of the Quality Payment Program, which we refer to as the “transition year” throughout this final rule with comment period; this transition year corresponds to the first performance period of the program, calendar year (CY) 2017, and the first payment year, CY 2019. We envision that it will take a few years to reach a steady state in the program, and we therefore anticipate a ramp-up process and gradual transition with less financial risk for clinicians in at least the first 2 years. In the transition year in 2017, we will test this performance category alignment, for example by allowing certain improvement activities that are completed using CEHRT to achieve a bonus score in the advancing care information performance category with the intent of analyzing adoption, and in future years, potentially adding activities that reinforce integration of the program. Our hope is for the program to evolve to the point where all the clinical activities captured in MIPS across the four performance categories reflect the single, unified goal of quality improvement.Start Printed Page 77011

4. Summary of the Major Provisions

a. Transition Year and Iterative Learning and Development Period

We recognize, as described through many insightful comments, that many eligible clinicians face challenges in understanding the requirements and being prepared to participate in the Quality Payment Program in 2017. As a result, we have decided to finalize transitional policies throughout this final rule with comment period, which will focus the program in its initial years on encouraging participation and educating clinicians, all with the primary goal of placing the patient at the center of the healthcare system. At the same time, we will also increase opportunities to join Advanced APMs, allowing eligible clinicians who chose to do so an opportunity to participate.

Given the wide diversity of clinical practices, the initial development period of the Quality Payment Program implementation would allow physicians to pick their pace of participation for the first performance period that begins January 1, 2017. Eligible clinicians will have three flexible options to submit data to MIPS and a fourth option to join Advanced APMs in order to become QPs, which would ensure they do not receive a negative payment adjustment in 2019.

In the transition year CY 2017 of the program, this rule finalizes a period during which clinicians and CMS will build capabilities to report and gain experience with the program. Clinicians can choose their course of participation in this year with four options.

(1) Clinicians can choose to report to MIPS for a full 90-day period or, ideally, the full year, and maximize the MIPS eligible clinician's chances to qualify for a positive adjustment. In addition, MIPS eligible clinicians who are exceptional performers in MIPS, as shown by the practice information that they submit, are eligible for an additional positive adjustment for each year of the first 6 years of the program.

(2) Clinicians can choose to report to MIPS for a period of time less than the full year performance period 2017 but for a full 90-day period at a minimum and report more than one quality measure, more than one improvement activity, or more than the required measures in the advancing care information performance category in order to avoid a negative MIPS payment adjustment and to possibly receive a positive MIPS payment adjustment.

(3) Clinicians can choose to report one measure in the quality performance category; one activity in the improvement activities performance category; or report the required measures of the advancing care information performance category and avoid a negative MIPS payment adjustment. Alternatively, if MIPS eligible clinicians choose to not report even one measure or activity, they will receive the full negative 4 percent adjustment.

(4) MIPS eligible clinicians can participate in Advanced APMs, and if they receive a sufficient portion of their Medicare payments or see a sufficient portion of their Medicare patients through the Advanced APM, they will qualify for a 5 percent bonus incentive payment in 2019.

We are finalizing the 2017 performance period for the 2019 MIPS payment year to be a transition year as part of the development period in the program. For this transition year, for MIPS the performance threshold will be lowered to a threshold of 3 points. Clinicians who achieve a final score of 70 or higher will be eligible for the exceptional performance adjustment, funded from a pool of $500 million.

For full participation in MIPS and in order to achieve the highest possible final scores, MIPS eligible clinicians are encouraged to submit measures and activities in all three integrated performance categories: Quality, improvement activities, and advancing care information. To address public comments on the cost performance category, the weighting of the cost performance category has been lowered to 0 percent for the transition year. For full participation in the quality performance category, clinicians will report on six quality measures, or one specialty-specific or subspecialty-specific measure set. For full participation in the advancing care information performance category, MIPS eligible clinicians will report on five required measures. For full participation in the improvement activities performance category, clinicians can engage in up to four activities, rather than the proposed six activities, to earn the highest possible score of 40.

For the transition year CY 2017, for quality, clinicians who submit one out of at least six quality measures will meet the MIPS performance threshold of 3; however, more measures are required for groups who submit measures using the CMS Web Interface. For the transition year CY 2017, for quality, higher measure points may be awarded based on achieving higher performance in the measure. For improvement activities, attesting to at least one improvement activity will also be sufficient to meet the MIPS performance threshold in the transition year CY 2017. For advancing care information, clinicians reporting on the required measures in that category will meet the performance threshold in the transition year. These transition year policies for CY 2017 will encourage participation by clinicians and will provide a ramp up period for clinicians to prepare for higher performance thresholds in the second year of the program.

Historical evidence has shown that clinical practices of all sizes can successfully submit data, including over 110,000 solo and small practices with 15 or fewer clinicians who participated in PQRS in 2015. The transition year and development period approach gives clinicians structured, practical choices that can best suit their practices. Resources will be made available to assist clinicians and practices through this transition. The hope is that by lowering the barriers to participation at the outset, we can set the foundation for a program that supports long-term, high-quality patient care through feedback and open communication between CMS and other stakeholders.

We anticipate that the iterative learning and development period will last longer than the first year, CY 2017, of the program as we move towards a steady state; therefore, we envision CY 2018 to also be transitional in nature to provide a ramp-up of the program and of the performance thresholds. We anticipate making proposals on the parameters of this second transition year through rule-making in 2017.

b. Legacy Quality Reporting Programs

This final rule with comment period will sunset payment adjustments under the current Medicare EHR Incentive Program for EPs (section 1848(o) of the Act), the PQRS (section 1848(k) and (m) of the Act), and the VM (section 1848(p) of the Act) programs after CY2018. Components of these three programs will be carried forward into MIPS. This final rule with comment period establishes new subpart O of our regulations at 42 CFR part 414 to implement the new MIPS program as required by the MACRA.

c. Significant Changes From Proposed Rule

In developing this final rule with comment period, we sought feedback from stakeholders throughout the process, including through Requests for Information in October 2015 and through the comment process for the proposed rule from April to June 2016. We received thousands of comments from a broad range of sources including professional associations and societies, physician practices, hospitals, patient Start Printed Page 77012groups, and health IT vendors, and we thank our many commenters and acknowledge their valued input throughout the proposed rule process. In response to comments to the proposed rule, we have made significant changes in this final rule with comment period, including (1) bolstering support for small and independent practices; (2) strengthening the movement towards Advanced Alternative Payment Models by offering potential new opportunities such as the Medicare ACO Track 1+ (3) securing a strong start to the program with a flexible, pick-your-own-pace approach to the initial years of the program; and (4) connecting the statutory domains into one unified program that supports clinician-driven quality improvement. These themes are illustrated in the following specific policy changes: (1) The creation of a transition year and iterative learning and development period in the beginning of the program; (2) the adjustment of the MIPS low-volume threshold; (3) the establishment of an Advanced APM financial risk standard that promotes participation in robust, high-quality models; (4) the simplification of prior “all-or-nothing” requirements in the use of certified EHR technology; and (5) the establishment of Medical Home Model standards that promote care coordination.

We intend to continue open communication with stakeholders, including consultation with tribes and tribal officials, on an ongoing basis as we develop the Quality Payment Program in future years.

d. Small Practices

As outlined above, protection of small, independent practices is an important thematic objective for this final rule with comment. For 2017, many small practices will be excluded from new requirements due to the low-volume threshold, which has been set at less than or equal to $30,000 in Medicare Part B allowed charges or less than or equal to 100 Medicare patients, representing 32.5 percent of pre-exclusion Medicare clinicians but only 5 percent of Medicare Part B spending. Stakeholder comments suggested setting a higher low-volume threshold for exclusion from MIPS but allowing clinicians that would be excluded by the threshold to opt in to the program if they wished to report to MIPS and receive a MIPS payment adjustment for the year. We considered this option but determined that it was inconsistent with the statutory MIPS exclusion based on the low-volume threshold. We anticipate that more clinicians will be determined to be eligible to participate in the program in future years.

MACRA also provides that solo and small practices may join “virtual groups” and combine their MIPS reporting. Many commenters suggested that we allow groups with more than 10 clinicians to participate as virtual groups. As noted, the statute limits the virtual group option to individuals and groups of not more than 10 clinicians. We are not implementing virtual groups in the transition year CY 2017 of the program; however, through the policies of the transition year and development period, we believe we have addressed some of the concerns expressed by clinicians hesitant to participate in the Quality Payment Program. CMS wants to make sure the virtual group technology is meaningful and simple to use for clinicians, and we look forward to stakeholder engagement on how to structure and implement virtual groups in future years of the program.

In keeping with the objectives of providing education about the program and maximizing participation, and as mandated by the MACRA, $100 million in technical assistance will be available to MIPS eligible clinicians in small practices, rural areas, and practices located in geographic health professional shortage areas (HPSAs), including IHS, tribal, and urban Indian clinics, through contracts with quality improvement organizations, regional health collaboratives, and others to offer guidance and assistance to MIPS eligible clinicians in practices of 15 or fewer MIPS eligible clinicians. Priority will be given to practices located in rural areas, defined as clinicians in zip codes designated as rural, using the most recent Health Resources and Services Administration (HRSA) Area Health Resource File data set available; medically underserved areas (MUAs); and practices with low MIPS final scores or in transition to APM participation. The MACRA also includes provisions requiring an examination of the pooling of financial risk for physician practices, in particular for small practices. Specifically, section 101(c)(2)(C) of MACRA requires the Government Accountability Office (GAO) to submit a report to Congress, not later than January 1, 2017, examining whether entities that pool financial risk for physician practices, such as independent risk managers, can play a role in supporting physician practices, particularly small physician practices, in assuming financial risk for the treatment of patients. We have been closely engaged with the GAO throughout their study to better understand the unique needs and challenges faced by clinicians in small practices and practices in rural or health professional shortage areas. We have provided information to the GAO, and the GAO has shared some of their initial findings regarding these challenges. We look forward to further engagement with the GAO on this topic and to the release of GAO's final report. Using the knowledge obtained from small practices, other stakeholders, and the public, as well as from GAO, we continue to work to improve the flexibility and support available to small, underserved, and rural practices. Throughout the evolution of the Quality Payment Program that will unfold over the years to come, CMS is committed to working together with stakeholders to address the unique challenges these practices encounter.

Using updated policies for the transition year and development period, we performed an updated regulatory impact analysis, including for small and solo practices. With the extensive changes to policy and increased flexibility, we believe that estimating impacts of this final rule with comment period using only historic 2015 quality submission data significantly overestimates the impact on small and solo practices. Although small and solo practices have historically been less likely to engage in PQRS and quality reporting, we believe that small and solo practices will respond to MIPS by participating at a rate close to that of other practice sizes. In order to quantify the impact of the rule on MIPS eligible clinicians, including small and solo practices, we have prepared two sets of analyses that assume the participation rates for some categories of small practices will be similar to those of other practice size categories. Specifically, our primary analysis assumes that each practice size grouping will achieve at least 90 percent participation rate and our alternative assumption is that each practice size grouping will achieve at least an 80 percent participation rate. In both sets of analyses, we estimate that over 90 percent of MIPS eligible clinicians will receive a positive or neutral MIPS payment adjustment in the transition year, and that at least 80 percent of clinicians in small and solo practices with 1-9 clinicians will receive a positive or neutral MIPS payment adjustment.

e. Advanced Alternative Payment Models (Advanced APMs)

In this rule, we finalize requirements we will use for the purposes of the incentives for participation in Advanced Start Printed Page 77013APMs, and the following is a summary of our finalized policies. The MACRA defines APM for the purposes of the incentive as a model under section 1115A of the Act (excluding a health care innovation award), the Shared Savings Program under section 1899 of the Act, a demonstration under section 1866C of the Act, or a demonstration required by federal law.

APMs represent an important step forward in the Administration's efforts to move our healthcare system from volume-based to value-based care. APMs that meet the criteria to be Advanced APMs provide the pathway through which eligible clinicians, who would otherwise participate in MIPS, can become Qualifying APM Participants (QPs), and therefore, earn incentive payments for their Advanced APM participation. In the proposed rule, we estimated that 30,000 to 90,000 clinicians would be QPs in 2017. With new Advanced APMs expected to become available for participation in 2017 and 2018, including the Medicare ACO Track 1 Plus (1+), and anticipated amendments to reopen applications for or modify current APMs, such as the Maryland All-Payer Model and Comprehensive Care for Joint Replacement (CJR) model, we anticipate higher numbers of QPs—approximately 70,000 to 120,000 in 2017 and 125,000 to 250,000 in 2018.

As discussed in section II.F.4.b. of this final rule with comment period, we are exploring development of the Medicare ACO Track 1+ Model to begin in 2018. The model would be voluntary for ACOs currently participating in Track 1 of the Shared Savings Program or ACOs seeking to participate in the Shared Savings Program for the first time. It would test a payment model that incorporates more limited downside risk than is currently present in Tracks 2 or 3 of the Shared Savings Program but sufficient financial risk in order to be an Advanced APM. We will announce additional information about the model in the future.

This rule finalizes two types of Advanced APMs: Advanced APMs and Other Payer Advanced APMs. To be considered an Advanced APM, an APM must meet all three of the following criteria, as required under section 1833(z)(3)(D) of the Act: (1) The APM must require participants to use CEHRT; (2) The APM must provide for payment for covered professional services based on quality measures comparable to those in the quality performance category under MIPS and; (3) The APM must either require that participating APM Entities bear risk for monetary losses of a more than nominal amount under the APM, or be a Medical Home Model expanded under section 1115A(c) of the Act. In this rule, we finalize proposals pertaining to all of these criteria.

To be an Other Payer Advanced APM, as set forth in section 1833(z)(2) of the Act, a payment arrangement with a payer (for example, Medicaid or a commercial payer) must meet all three of the following criteria: (1) The payment arrangement must require participants to use CEHRT; (2) The payment arrangement must provide for payment for covered professional services based on quality measures comparable to those in the quality performance category under MIPS and; (3) The payment arrangement must require participants to either bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures; or be a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act.

We are completing an initial set of Advanced APM determinations that we will release as soon as possible but no later than January 1, 2017. For new APMs that are announced after the initial determination, we will include Advanced APM determinations in conjunction with the first public notice of the APM, such as the Request for Applications (RFA) or final rule. All determinations of Advanced APMs will be posted on our Web site and updated on an ad hoc basis, but no less frequently than annually, as new APMs become available and others end or change.

An important avenue for the creation of innovative payment models is the PTAC, created by the MACRA. The PTAC is an 11-member independent federal advisory committee to the HHS Secretary. The PTAC will review stakeholders' proposed PFPMs, and make comments and recommendations to the Secretary regarding whether the PFPMs meet criteria established by the Secretary. PTAC comments and recommendations will be reviewed by the CMS Innovation Center and the Secretary, and we will post a detailed response to them on the CMS Web site.

(i) QP Determination

QPs are eligible clinicians in an Advanced APM who have a certain percentage of their patients or payments through an Advanced APM. QPs are excluded from MIPS and receive a 5 percent incentive payment for a year beginning in 2019 through 2024. We finalize our proposal that professional services furnished at Critical Access Hospitals (CAHs), Rural Health Clinics (RHCs), and Federally Qualified Health Centers (FQHCs) that meet certain criteria be counted towards the QP determination using the patient count method.

We finalize definitions of Medical Home Model and Medicaid Medical Home Model and the unique standards by which Medical Home Models may meet the financial risk criterion to be an Advanced APM.

The statute sets thresholds for the level of participation in Advanced APMs required for an eligible clinician to become a QP for a year. The Medicare Option, based on Part B payments for covered professional services or counts of patients furnished covered professional services under Part B, is applicable beginning in the payment year 2019. The All-Payer Combination Option, which utilizes the Medicare Option as well as an eligible clinician's participation in Other Payer Advanced APMs, is applicable beginning in the payment year 2021. For eligible clinicians to become QPs through the All-Payer Combination Option, an Advanced APM Entity or eligible clinician must participate in an Advanced APM under Medicare and also submit information to CMS so that we can determine whether payment arrangements with non-Medicare payers are an Other Payer Advanced APMs and whether an eligible clinician meets the requisite QP threshold of participation. We are finalizing our methodologies to evaluate eligible clinicians using the Medicare and All-Payer Combination Options.

We are finalizing the two methods by which we will calculate Threshold Scores to compare to the QP thresholds and make QP determinations for eligible clinicians. The payment amount method assesses the amount of payments for Part B covered professional services that are furnished through an Advanced APM. The patient count method assesses the amount of patients furnished Part B covered professional services through an Advanced APM.

We are finalizing our proposal to identify individual eligible clinicians by a unique APM participant identifier using the individuals' APM, APM Entity, and TIN/NPI combinations, and to assess as an APM Entity group all individual eligible clinicians listed as participating in an Advanced APM Entity to determine their QP status for a year. We are finalizing that if an individual eligible clinician who participates in multiple Advanced APM Entities does not achieve QP status through participation in any single APM Entity, we will assess the eligible Start Printed Page 77014clinician individually to determine QP status based on combined participation in Advanced APMs.

We are finalizing the method to calculate and disburse the lump-sum APM Incentive Payments to QPs, and we are finalizing a specific approach for calculating the APM Incentive Payment when a QP also receives non-FFS payments or has received payment adjustments through the Medicare EHR Incentive Program, PQRS, VM, or MIPS during the prior period used for determining the APM Incentive Payment.

We are finalizing a modified policy such that, following a final determination that an Advanced APM Entity group or eligible clinician is determined to be a Partial Qualifying APM Participant (Partial QP), the Advanced APM Entity—or eligible clinician in the case of an individual determination—will make an election on behalf of all of its eligible clinicians in the group of whether to report to MIPS, thus making all eligible clinicians in the Advanced APM Entity group subject to MIPS payment adjustments; or not report to MIPS, thus excluding all eligible clinicians in the APM Entity group from MIPS adjustments. We finalize our proposals to vet and monitor APM Entities, Advanced APM Entities, and eligible clinicians participating in those entities. We are finalizing a definition for PFPMs and criteria for use by the PTAC in fulfilling its responsibility to evaluate proposals for PFPMs.

We are finalizing an accelerated timeline for making QP determinations, and will notify eligible clinicians of their QP status as soon as possible, in advance of the end of the MIPS performance period so that QPs will know whether they are excluded from MIPS prior to having to submit information to CMS for purposes of MIPS.

We are finalizing the requirement that MIPS eligible clinicians, as well as EPs, eligible hospitals, and CAHs under the existing Medicare and Medicaid EHR Incentive Programs demonstrate cooperation with certain provisions concerning blocking the sharing of information under section 106(b)(2) of the MACRA and, separately, to demonstrate engagement with activities that support health care providers with the performance of their CEHRT such as cooperation with ONC direct review of certified health information technologies.

f. Merit-Based Incentive Payment System (MIPS)

In establishing MIPS, this final rule with comment period will define MIPS participants as “MIPS eligible clinicians” rather than “MIPS EPs” as that term is defined at section 1848(q)(1)(C) and used throughout section 1848(q) of the Act. MIPS eligible clinicians will include physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and groups that include such clinicians who bill under Medicare Part B. The rule finalizes definitions and requirements for groups. In addition to finalizing definitions for MIPS eligible clinicians, the rule also finalizes rules for the specific Medicare-enrolled clinicians that will be excluded from MIPS, including newly Medicare-enrolled MIPS eligible clinicians, QPs, certain Partial QPs, and clinicians that fall under the finalized low-volume threshold.

For the 2017 performance period, we estimate that more than half of clinicians—approximately 738,000 to 780,000—billing under the Medicare PFS will be excluded from MIPS due to several factors, including the MACRA itself. We estimate that nearly 200,000 clinicians, or approximately 14.4 percent, are not one of the eligible types of clinicians for the transition year CY 2017 of MIPS under section 1848(q)(1)(C) of the Act. The largest cohort of clinicians excluded from MIPS is low-volume clinicians, defined as those clinicians with less than or equal to $30,000 in allowed charges or less than or equal to 100 Medicare patients, representing approximately 32.5 percent of all clinicians billing Medicare Part B services or over 380,000 clinicians. Additionally, between 70,000 and 120,000 clinicians (approximately 5-8 percent of all clinicians billing under the Medicare Part B) will be excluded from MIPS due to being QPs based on participation in Advanced APMs. In aggregate, the eligible clinicians excluded from MIPS represent only 22 to 27 percent of total Part B allowed charges.

This rule finalizes MIPS performance standards and a minimum MIPS performance period of any 90 continuous days during CY 2017 (January 1 through December 31) for all measures and activities applicable to the integrated performance categories. After consideration of public comments, this rule finalizes a shorter than annual performance period in 2017 to allow flexible participation options for MIPS eligible clinicians as the program begins and evolves over time. For performance periods occurring in 2017, MIPS eligible clinicians will be able to pick a pace of participation that best suits their practices, including submitting data, in special circumstances as discussed in section II.E.5. of this rule, for a period of less than 90 days, to avoid a negative MIPS payment adjustment. Further, we are finalizing our proposal to use performance in 2017 as the performance period for the 2019 payment adjustment. Therefore, the first performance period will start in 2017 and consist of a minimum period of any 90 continuous days during the calendar year in order for clinicians to be eligible for payment adjustment above neutral. Performance in that period of 2017 will be used to determine the 2019 payment adjustment. This timeframe is needed to allow data and claims to be submitted and data analysis to occur in the initial years. In subsequent years, we intend to explore ways to shorten the period between the performance period and the payment year, and ongoing performance feedback will be provided more frequently. The final policies for CY 2017 provide flexibilities to ensure clinicians have ample participation opportunities.

As directed by the MACRA, this rule finalizes measures, activities, reporting, and data submission standards across four integrated performance categories: Quality, cost, improvement activities, and advancing care information, each linked by the same overriding mission of supporting care improvement under the vision of one Quality Payment Program. Consideration will be given to the application of measures and activities to non-patient facing MIPS eligible clinicians.

Under the requirements finalized in this rule, there will be options for reporting as an individual MIPS eligible clinician or as part of a group. Some data may be submitted via relevant third party intermediaries, such as qualified clinical data registries (QCDRs), health IT vendors,[1] qualified registries, and CMS-approved survey vendors.

Start Printed Page 77015

Within each performance category, we are finalizing specific requirements for full participation in MIPS which involves submitting data on quality measures, improvement activities, and use of certified EHR technology on a minimum of any continuous 90 days up to the full calendar year in 2017 in order to be eligible for a positive MIPS payment adjustment. It is at the MIPS eligible clinician's discretion whether to submit data for the same 90-day period for the various measures and activities or for different time periods for different measures and activities. Note that during the 2017 transition year, MIPS eligible clinicians may choose to report a minimum of a single measure in the quality performance category, a single activity in the improvement activities performance category or the required measures in the advancing care information performance category, in order to avoid a negative payment adjustment. For full participation in MIPS, the specific requirements are as follows:

(i) Quality

Quality measures will be selected annually through a call for quality measures process, and a final list of quality measures will be published in the Federal Register by November 1 of each year. For MIPS eligible clinicians choosing full participation in MIPS and the potential for a higher payment adjustment, we note that for a minimum of a continuous 90-day performance period, the MIPS eligible clinician or group will report at least six measures including at least one outcome measure if available. If fewer than six measures apply to the individual MIPS eligible clinician or group, then the MIPS eligible clinician or group will only be required to report on each measure that is applicable.

Alternatively, for a minimum of a continuous 90-day period, the MIPS eligible clinician or group can report one specialty-specific measure set, or the measure set defined at the subspecialty level, if applicable. If the measure set contains fewer than six measures, MIPS eligible clinicians will be required to report all available measures within the set. If the measure set contains six or more measures, MIPS eligible clinicians can choose six or more measures to report within the set. Regardless of the number of measures that are contained in the measure set, MIPS eligible clinicians reporting on a measure set will be required to report at least one outcome measure or, if no outcome measures are available in the measure set, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) within the measure set in lieu of an outcome measure.

(ii) Improvement Activities

Improvement activities are those that support broad aims within healthcare delivery, including care coordination, beneficiary engagement, population management, and health equity. In response to comments from experts and stakeholders across the healthcare system, improvement activities were given relative weights of high and medium. We are reducing the number of activities required to achieve full credit from six medium-weighted or three high-weighted activities to four medium-weighted or two high-weighted activities to receive full credit in this performance category in CY 2017. For small practices, rural practices, or practices located in geographic health professional shortage areas (HPSAs), and non-patient facing MIPS eligible clinicians, we will reduce the requirement to only one high-weighted or two medium-weighted activities. We also expand our definition of how CMS will recognize a MIPS eligible clinician or group as being a certified patient-centered medical home or comparable specialty practice to include certification from a national program, regional or state program, private payer or other body that administers patient-centered medical home accreditation. As previously mentioned, in recognition of improvement activities as supporting the central mission of a unified Quality Payment Program, we will include a designation in the inventory of improvement activities of which activities also qualify for the advancing care information bonus score, consistent with our desire to recognize that EHR technology is often deployed to improve care in ways that our programs should recognize.

(iii) Advancing Care Information Performance Category

Measures and objectives in the advancing care information performance category focus on the secure exchange of health information and the use of certified electronic health record technology (CEHRT) to support patient engagement and improved healthcare quality. We are maintaining alignment of the advancing care information performance category with the other integrated performance categories for MIPS. We are reducing the total number of required measures from eleven in the proposed rule to only five in our final policy. All other measures would be optional for reporting. Reporting on all five of the required measures would earn the MIPS eligible clinician 50 percent. Reporting on the optional measures would allow a clinician to earn a higher score. For the transition year, we will award a bonus score for improvement activities that utilize CEHRT and for reporting to public health or clinical data registries.

Public commenters requested that the advancing care information performance category allow for reporting on “use cases” such as the use of CEHRT to manage referrals and consultations (“closing the referral loop”) and other practice-based activities for which CEHRT is used as part of the typical workflow. This is an area we intend to explore in future rulemaking but did not finalize any such policies in this rule. However, for the 2017 transition year, we will award bonus points for improvement activities that utilize CEHRT and for reporting to a public health or clinical data registry, reflecting the belief that the advancing care information performance category should align with the other performance categories to achieve the unified goal of quality improvement.

(iv) Cost

For the transition year, we are finalizing a weight of zero percent for the cost performance category in the final score, and MIPS scoring in 2017 will be determined based on the other three integrated MIPS performance categories. Cost measures do not require reporting of any data by MIPS eligible clinicians to CMS. Although cost measures will not be used to determine the final score in the transition year, we intend to calculate performance on certain cost measures and give this information in performance feedback to clinicians. We intend to calculate measures of total per capita costs for all attributed beneficiaries and a Medicare Spending per Beneficiary (MSPB) measure. In addition, we are finalizing 10 episode-based measures that were previously made available to clinicians in feedback reports and met standards for reliability. Starting in performance year 2018, as performance feedback is available on at least an annual basis, the cost performance category contribution to the final score will gradually increase from 0 to the 30 percent level required Start Printed Page 77016by MACRA by the third MIPS payment year of 2021.

(v) Clinicians in MIPS APMs

We are finalizing standards for measures, scoring, and reporting for MIPS eligible clinicians across all four performance categories outlined in this section II.E.5.h of this final rule with comment period. Beginning in 2017, some APMs, by virtue of their structure, will not meet statutory requirements to be categorized as Advanced APMs. Eligible clinicians in these APMs, hereafter referred to as MIPS APMs, will be subject to MIPS reporting requirements and the MIPS payment adjustment. In addition, eligible clinicians who are in Advanced APMs but do not meet participation thresholds to be excluded from MIPS for a year will be subject to the scoring standards for MIPS reporting requirements and the MIPS payment adjustment. In response to comments, in an effort to recognize these eligible clinicians' participation in delivery system reform and to avoid potential duplication or conflicts between these APMs and MIPS, we finalize an APM scoring standard that is different from the generally applicable standard. We finalize our proposal that MIPS eligible clinicians who participate in MIPS APMs will be scored using the APM scoring standard instead of the generally applicable MIPS scoring standard.

(vi) Scoring Under MIPS

We are finalizing that MIPS eligible clinicians have the flexibility to submit information individually or via a group or an APM Entity group; however, the MIPS eligible clinician will use the same identifier for all performance categories. The finalized scoring methodology has a unified approach across all performance categories, which will help MIPS eligible clinicians understand in advance what they need to do in order to perform well in MIPS. The three performance category scores (quality, improvement activities, and advancing care information) will be aggregated into a final score. The final score will be compared against a MIPS performance threshold of 3 points. The final score will be used to determine whether a MIPS eligible clinician receives an upward MIPS payment adjustment, no MIPS payment adjustment, or a downward MIPS payment adjustment as appropriate. Upward MIPS payment adjustments may be scaled for budget neutrality, as required by MACRA. The final score will also be used to determine whether a MIPS eligible clinician qualifies for an additional positive adjustment factor for exceptional performance. The performance threshold will be set at 3 points for the transition year, such that clinicians engaged in the program who successfully report one quality measure can avoid a downward adjustment. MIPS eligible clinicians submitting additional data for one or more of the three performance categories for at least a full 90-day period may quality for varying levels of positive adjustments.

In future years of the program, we will require longer performance periods and higher performance in order to avoid a negative MIPS payment adjustment.

(vii) Performance Feedback

We are finalizing a process for providing performance feedback to MIPS eligible clinicians. Initially, we will provide performance feedback on an annual basis. In future years, we aim to provide performance feedback on a more frequent basis, as well as providing feedback on the performance categories of improvement activities and advancing care information in line with clinician requests for timely, actionable feedback that they can use to improve care. We are finalizing our proposal to make performance feedback available using a web-based application. Further, we are finalizing our proposal to leverage additional mechanisms such as health IT vendors and registries to help disseminate data contained in the performance feedback to MIPS eligible clinicians where applicable.

(viii) Targeted Review Processes

We are finalizing a targeted review process under MIPS wherein a MIPS eligible clinician may request that we review the calculation of the MIPS payment adjustment factor and, as applicable, the calculation of the additional MIPS payment adjustment factor applicable to such MIPS eligible clinician for a year.

(ix) Third Party Intermediaries

We are finalizing requirements for third party data submission to MIPS that are intended to decrease burden to individual clinicians. Specifically, qualified registries, QCDRs, health IT vendors, and CMS-approved survey vendors will have the ability to act as intermediaries on behalf of MIPS eligible clinicians and groups for submission of data to CMS across the quality, improvement activities, and advancing care information performance categories.

(x) Public Reporting

We are finalizing a process for public reporting of MIPS information through the Physician Compare Web site, with the intention of promoting fairness and transparency. We are finalizing public reporting of a MIPS eligible clinician's data; for each program year, we will post on a public Web site, in an easily understandable format, information regarding the performance of MIPS eligible clinicians or groups under MIPS.

5. Payment Adjustments

We estimate that approximately 70,000 to 120,000 clinicians will become QPs in 2017 and approximately 125,000 to 250,000 clinicians will become QPs in 2018 through participation in Advanced APMs; they are estimated to receive between $333 million and $571 million in APM Incentive Payments for CY 2019. As with MIPS, we expect that APM participation will drive quality improvement for clinical care provided to Medicare beneficiaries and to all patients in the health care system.

Under the policies finalized in this rule, we estimate that, between approximately 592,000 and 642,000 eligible clinicians will be required to participate in MIPS in its transition year. In 2019, MIPS payment adjustments will be applied based on MIPS eligible clinicians' performance on specified measures and activities within three integrated performance categories; the fourth category of cost, as previously outlined, will be weighted to zero in the transition year. Assuming that 90 percent of eligible clinicians of all practice sizes participate in the program, we estimate that MIPS payment adjustments will be approximately equally distributed between negative MIPS payment adjustments ($199 million) and positive MIPS payment adjustments ($199 million) to MIPS eligible clinicians, to ensure budget neutrality. Positive MIPS payment adjustments will also include an additional $500 million for exceptional performance payments to MIPS eligible clinicians whose performance meets or exceeds a threshold final score of 70. These MIPS payment adjustments are expected to drive quality improvement in the provision of MIPS eligible clinicians' care to Medicare beneficiaries and to all patients in the health care system. However, the distribution could change based on the final population of MIPS eligible clinicians for CY 2019 and the distribution of scores under the program. We believe that starting with these modest initial MIPS payment adjustments, representing less than 0.2 percent of Medicare expenditures for physician and clinical services, is in the long-term best interest of maximizing Start Printed Page 77017participation and starting the Quality Payment Program off on the right foot, even if it limits the upside during the transition year. The increased availability of Advanced APM opportunities, including through Medical Home models, also provides earlier avenues to earn bonus payments for those who choose to participate.

6. The Broader Context of Delivery System Reform and Healthcare System Innovation

In January 2015, the Administration announced new goals for transforming Medicare by moving away from traditional FFS payments in Medicare towards a payment system focused on linking physician reimbursements to quality care through APMs (http://www.hhs.gov/​about/​news/​2015/​01/​26/​better-smarter-healthier-in-historic-announcement-hhs-sets-clear-goals-and-timeline-for-shifting-medicare-reimbursements-from-volume-to-value.html#) and other value-based purchasing arrangements. This is part of an overarching Administration strategy to transform how health care is delivered in America, changing payment structures to improve quality and patient health outcomes. The policies finalized in this rule are intended to continue to move Medicare away from a primarily volume-based FFS payment system for physicians and other professionals.

The Affordable Care Act includes a number of provisions, for example, the Medicare Shared Savings Program, designed to improve the quality of Medicare services, support innovation and the establishment of new payment models, better align Medicare payments with health care provider costs, strengthen Medicare program integrity, and put Medicare on a firmer financial footing.

The Affordable Care Act created the Center for Medicare and Medicaid Innovation (Innovation Center). The Innovation Center was established by section 1115A of the Act (as added by section 3021 of the Affordable Care Act). The Innovation Center's mandate gives it flexibility within the parameters of section 1115A of the Act to select and test promising innovative payment and service delivery models. The Congress created the Innovation Center for the purpose of testing innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care provided to those individuals who receive Medicare, Medicaid, or CHIP benefits. See https://innovation.cms.gov/​about/​index.html. The Secretary may through rulemaking expand the duration and scope of a model being tested if (1) the Secretary finds that such expansion (i) is expected to reduce spending without reducing the quality of care, or (ii) improve the quality of patient care without increasing spending; (2) the CMS Chief Actuary certifies that such expansion would reduce (or would not result in any increase in) net program spending under applicable titles; and (3) the Secretary finds that such expansion would not deny or limit the coverage or provision of benefits under the applicable title for applicable individuals.

The Innovation Center's portfolio of models has attracted participation from a broad array of health care providers, states, payers, and other stakeholders, and serves Medicare, Medicaid, and CHIP beneficiaries in all 50 states, the District of Columbia, and Puerto Rico. We estimate that over 4.7 million Medicare, Medicaid, and CHIP beneficiaries are or soon will be receiving care furnished by the more than 61,000 eligible clinicians currently participating in models tested by the CMS Innovation Center.

Beyond the care improvements for these beneficiaries, the Innovation Center models are affecting millions of additional Americans by engaging thousands of other health care providers, payers, and states in model tests and through quality improvement efforts across the country. Many payers other than CMS have implemented alternative payment arrangements or models, or have collaborated in the Innovation Center models. The participation of multiple payers in alternative delivery and payment models increases momentum for delivery system transformation and encourages efficiency for health care organizations.

The Innovation Center works directly with other CMS components and colleagues throughout the federal government in developing and testing new payment and service delivery models. Other federal agencies with which the Innovation Center has collaborated include the Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), Agency for Healthcare Research and Quality (AHRQ), Office of the National Coordinator for Health Information Technology (ONC), Administration for Community Living (ACL), Department of Housing and Urban Development (HUD), Administration for Children and Families (ACF), and the Substance Abuse and Mental Health Services Administration (SAMHSA). These collaborations help the Innovation Center effectively test new models and execute mandated demonstrations.

7. Stakeholder Input

In developing this final rule with comment period, we sought feedback from stakeholders and the public throughout the process such as in the 2016 Medicare PFS Proposed Rule; the Request for Information Regarding Implementation of the Merit-based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models (hereafter referred to as the MIPS and APMs RFI); listening sessions; conversations with a wide number of stakeholders; and consultation with tribes and tribal officials through an All Tribes' Call on May 19, 2016 and several conversations with the CMS' Tribal Technical Advisory Group. Through the MIPS and APMs RFI published in the Federal Register on October 1, 2015 (80 FR 59102 through 59113), the Secretary of Health and Human Services (the Secretary) solicited comments regarding implementation of certain aspects of the MIPS and broadly sought public comments on the topics in section 101 of the MACRA, including the incentive payments for participation in APMs and increasing transparency of PFPMs. We received numerous public comments in response to the MIPS and APMs RFI from a broad range of sources including professional associations and societies, physician practices, hospitals, patient groups, and health IT vendors. On May 9, 2016, we published in the Federal Register a proposed rule for the Merit-based Incentive Payment System and Alternative Payment Model Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models (81 FR 28161 through 28586). In our proposed rule, we provided the public with proposed policies, implementation strategies, and regulation text, in addition to seeking additional comments on alternative and future approaches for MIPS and APMs. The comment period closed June 27, 2016.

In response to both the RFI and the proposed rule, we received a high degree of interest from a broad spectrum of stakeholders. We thank our many commenters and acknowledge their valued input throughout the proposed rule process. We discuss and respond to the substance of relevant comments in the appropriate sections of this final rule with comment period. In general, commenters continue to support establishment of the Quality Payment Program and maintain optimism as we Start Printed Page 77018move from FFS Medicare payment towards an enhanced focus on the quality and value of care. Public support for our proposed approach and policies in the proposed rule focused on the potential for improving the quality of care delivered to beneficiaries and increasing value to the public—while rewarding eligible clinicians for their efforts. In this early stage of a new program, commenters urged CMS to maintain flexibility and promote maximized clinician participation in MIPS and APMs. Commenters also expressed a willingness and desire to work with CMS to increase the relevance of MIPS activities and measures for physicians and patients and to expand the number and scope of APMs. We have sought to adopt these sentiments throughout relevant sections of this final rule with comment period. Commenters continue to express concern with elements of the legacy programs incorporated into MIPS. We appreciate the many comments received regarding the proposed measures and activities and address those throughout this final rule with comment period. We intend to work with stakeholders to continually seek to connect the program to activities and measures that will result in improvement in care for Medicare beneficiaries. Commenters also continue to be concerned regarding the burden of current and future requirements. Although many commenters recognize the reduced burden from streamlined reporting in MIPS compared to prior programs, they believe CMS could undertake additional steps to improve reporting efficiency. We appreciate provider concerns with reporting burden and have tried to reduce burden where possible while meeting the intent of the MACRA, including our obligations to improve patient outcomes through this quality program.

In several cases, commenters made suggestions for changes that we considered and ultimately found to be inconsistent with the statute. In keeping with our objectives of maintaining transparency in the program, we outline in the appropriate sections of the rule suggestions from commenters that were considered but found to be inconsistent with the statute.

Commenters have many concerns about their ability to participate effectively in MIPS in 2017 and the program's impacts on small practices, rural practitioners, and various specialty practitioner types. We have attempted to address these concerns by including transitional policies and additional flexibility in relevant sections of the final rule with comment period to encourage participation by all eligible clinicians and practitioner types, and avoid undue impact on any particular group.

Commenters present substantial enthusiasm for broadening opportunities to participate in APMs and the development of new Advanced APMs. Commenters suggest a number of resources should be made available to assist them in moving towards participation in APMs and have submitted numerous proposals for enhancing the APM portfolio and shortening the development process for new APMs. In particular, commenters urged us to modify existing Innovation Center models so they can be classified as Advanced APMs. We appreciate commenters' eagerness to participate in Advanced APMs and to be a part of transforming care. While not within the scope of this rule, we note that CMS has developed in conjunction with this rule a new strategic vision for the development of Advanced APMs over the coming years that will provide significantly enhanced opportunities for clinicians to participate in the program. We thank stakeholders again for their considered responses throughout our process, in various venues, including comments to the MIPS and APMs RFI and the proposed rule. We intend to continue open communication with stakeholders, including consultation with tribes and tribal officials, on an ongoing basis as we develop the Quality Payment Program in future years.

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

A. Establishing MIPS and the Advanced APM Incentive

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

B. Program Principles and Goals

Through the implementation of the Quality Payment Program, we strive to continue to support health care quality, efficiency, and patient safety. MIPS promotes better care, healthier people, and smarter spending by evaluating MIPS eligible clinicians using a final score that incorporates MIPS eligible clinicians' performance on quality, cost, improvement activities, and advancing care information. Under the incentives for participation in Advanced APMs, our goals, described in greater detail in section II.F of this final rule with comment period, are to expand the opportunities for participation in both APMs and Advanced APMs, improve care quality and reduce health care costs in current and future Advanced APMs, create clear and attainable standards for incentives, promote the continued flexibility in the design of APMs, and support multi-payer initiatives across the health care market. The Quality Payment Program is designed to encourage eligible clinicians to participate in Advanced APMs. The APM Incentive Payment will be available to eligible clinicians who qualify as QPs through Advanced APMs. MIPS eligible clinicians participating in APMs (who do not qualify as QPs) will receive favorable scoring under certain MIPS categories.

Our strategic objectives in developing the Quality Payment Program include: (1) Improve beneficiary outcomes through patient-centered MIPS and APM policy development and patient engagement and achieve smarter spending through strong incentives to provide the right care at the right time; (2) enhance clinician experience through flexible and transparent program design and interactions with exceptional program tools; (3) increase the availability and adoption of alternative payment models; (4) promote program understanding and participation through customized communication, education, outreach and support; (5) improve data and information sharing to provide accurate, timely, and actionable feedback to clinicians and other stakeholders; (6) deliver IT systems capabilities that meet the needs of users and are seamless, efficient and valuable on the front- and back-end; and (7) ensure operational excellence in program implementation and ongoing development.

C. Changes to Existing Programs

1. Sunsetting of Current Payment Adjustment Programs

Section 101(b) of the MACRA calls for the sunsetting of payment adjustments under three existing programs for Medicare enrolled physicians and other practitioners:

  • The PQRS that incentivizes EPs to report on quality measures;
  • The VM that provides for budget neutral, differential payment adjustment for EPs in physician groups and solo practices based on quality of care compared to cost; and
  • The Medicare EHR Incentive Program for EPs that entails meeting certain requirements for the use of CEHRT.

Accordingly, we are finalizing revisions to certain regulations Start Printed Page 77019associated with these programs. We are not deleting these regulations entirely, as the final payment adjustments under these programs will not occur until the end of 2018. For PQRS, we are revising § 414.90(e) introductory text and § 414.90(e)(1)(ii) to continue payment adjustments through 2018.

Similarly, for the Medicare EHR Incentive Program for EPs we are amending § 495.102(d) to remove references to the payment adjustment percentage for years after the 2018 payment adjustment year and add a terminal limit of the 2018 payment adjustment year.

We did not make changes to 42 CFR part 414, subpart N—Value-Based Payment Modifier Under the PFS (§§ 414.1200 through 414.1285). These regulations are already limited to certain years.

The following is a summary of the comments we received regarding sunsetting current payment adjustment programs:

Comment: Several commenters expressed appreciation for CMS's decision to streamline the prior reporting programs into MIPS.

Response: We appreciate the commenters support for our proposals.

Comment: Some commenters were confused by the term “sunsetting,” the timeline for when the prior programs “end,” and whether there would be an overlap in reporting.

Response: Because of the nature of regulatory text and statutory requirements, we cannot delete text from the public record in order to end or change regulatory programs. Instead, we must amend the text with a date that marks an end to the program, and we refer to this as “sunsetting.” We would also like to clarify that the PQRS, VM, and Medicare EHR Incentive Program for FFS EPs will “end” in 2018 because that is the final year in which payment adjustments for each of these programs will be applied. As the commenters noted, however, the reporting periods or performance periods associated with the 2018 payment year for each of these programs occur prior to 2018. As discussed in section II.E.4. of this final rule with comment period, beginning in 2017, MIPS eligible clinicians will report data for MIPS during at minimum any period of 90 continuous days within CY 2017, and MIPS payment adjustments will begin in 2019 based on the 2017 performance year. Eligible clinicians may also seek to qualify as QPs through participation in Advanced APMs. Eligible clinicians who are QPs for the year are not subject to the MIPS reporting requirements and payment adjustment.

We plan to provide additional educational materials so that clinicians can easily understand the timelines and requirements for the existing and the new programs.

Based on the comments received we are finalizing the revision to PQRS at § 414.90(e) introductory text and § 414.90(e)(1)(ii) and to the Medicare EHR Incentive Program at § 495.102(d) as proposed.

2. Supporting Health Care Providers With the Performance of Certified EHR Technology, and Supporting Health Information Exchange and the Prevention of Health Information Blocking

a. Supporting Health Care Providers With the Performance of Certified EHR Technology

We proposed to require EPs, eligible hospitals, and CAHs to attest (as part of their demonstration of meaningful use under the Medicare and Medicaid EHR Incentive Programs) that they have cooperated with the surveillance and direct review of certified EHR technology under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E. Similarly, we proposed to require such an attestation from all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM scoring standard.

As we note below, it is our intent to support MIPS eligible clinicians, eligible clinicians part of an APM Entity, EPs, eligible hospitals, and CAHs' (hereafter collectively referred to in this section as “health care providers”) participation in health IT surveillance and direct review activities. While cooperating with these activities may require prioritizing limited time and other resources, we note that ONC will work with health care providers to accommodate their schedules and consider other circumstances (80 FR 62715). Additionally, ONC has established certain safeguards that can minimize potential burden on health care providers in the event that they are asked to cooperate with the surveillance of their certified EHR technology. Examples of these safeguards, which we described in the proposed rule (81 FR 28171), include: (1) Requiring ONC-Authorized Certification Bodies (ONC-ACBs) to use consistent, objective, valid, and reliable methods when selecting locations at which to perform randomized surveillance of certified health IT (80 FR 62715); (2) allowing ONC-ACBs to use appropriate sampling methodologies to minimize disruption to any individual provider or class of providers and to maximize the value and impact of ONC-ACB surveillance activities for all providers and stakeholders (80 FR 62715); and (3) allowing ONC-ACBs to excuse a health care provider from surveillance and select a different health care provider under certain circumstances (80 FR 62716).

As background to this proposal, we noted that on October 16, 2015, ONC published the 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications final rule (“2015 Edition final rule”). The 2015 Edition final rule made changes to the ONC Health IT Certification Program that enhance the testing, certification, and surveillance of health IT. Importantly, the rule strengthened requirements for the ongoing surveillance of certified EHR technology and other health IT certified on behalf of ONC. Under these requirements established by the 2015 Edition final rule, ONC-ACBs are required to conduct more frequent and more rigorous surveillance of certified technology and capabilities “in the field” (80 FR 62707).

The purpose of in-the-field surveillance is to provide greater assurance that health IT meets certification requirements not only in a controlled testing environment, but also when used by health care providers in actual production environments (80 FR 62707). In-the-field surveillance can take two forms: First, ONC-ACBs conduct “reactive surveillance” in response to complaints or other indications that certified health IT may not conform to the requirements of its certification (45 CFR 170.556(b)). Second, ONC-ACBs carry out ongoing “randomized surveillance” based on a randomized sample of all certified Complete EHRs and Health IT Modules to assess certified capabilities and other requirements prioritized by the National Coordinator (45 CFR 170.556(c)). Consistent with the purpose of ONC-ACB surveillance—which is to verify that certified health IT performs in accordance with the requirements of its certification when it is implemented and used in the field—an ONC-ACB's assessment of a certified capability must be based on the use of the capability in the live production environment in which the capability has been implemented and is in use (45 CFR Start Printed Page 77020170.556(a)(1)) and must use production data unless test data is specifically approved by the National Coordinator (45 CFR 170.556(a)(2)). Throughout this section, we refer to surveillance by an ONC-ACB as “surveillance.”

On October 19, 2016, ONC will publish the ONC Enhanced Oversight and Accountability final rule, which enhances oversight under the ONC Health IT Certification Program by establishing processes to facilitate ONC's direct review and evaluation of the performance of certified health IT in certain circumstances, including in response to problems or issues that could pose serious risks to public health or safety (see the October 19, 2016 Federal Register). ONC's direct review of certified health IT may require ONC to review and evaluate the performance of health IT in the production environment in which it has been implemented. Throughout this section, we refer to actions carried out by ONC under the ONC Enhanced Oversight and Accountability final rule as “direct review.”

When carrying out ONC-ACB surveillance or ONC direct review, ONC-ACBs and/or ONC may request that health care providers supply information (for example, by way of telephone inquiries or written surveys) about the performance of the certified EHR technology capabilities the provider possesses and, when necessary, may request access to the provider's certified EHR technology (and data stored in such certified EHR technology) to confirm that capabilities certified by the developer are functioning appropriately. Health care providers may also be asked to demonstrate capabilities and other aspects of the technology that are the focus of such efforts.

In the Quality Payment Program proposed rule, we explained that these efforts to strengthen surveillance and direct review of certified health IT are critical to the success of HHS programs and initiatives that require the use of certified health IT to improve health care quality and the efficient delivery of care. We explained that effective ONC-ACB surveillance and ONC direct review is fundamental to providing basic confidence that the certified health IT used under the HHS programs consistently meets applicable standards, implementation specifications, and certification criteria adopted by the Secretary when it is used by health care providers, as well as by other persons with whom health care providers need to exchange electronic health information to comply with program requirements. In particular, the need to ensure that certified health IT consistently meets applicable standards, implementation specifications, and certification criteria is important both at the time the technology is certified (by meeting the requirements for certification in a controlled testing environment) and on an ongoing basis to ensure that the technology continues to meet certification requirements when it is actually implemented and used by health care providers in real-world production environments. We explained that efforts to strengthen surveillance and direct review of certified EHR technology in the field will become even more important as the types and capabilities of certified EHR technology continue to evolve and with the onset of Stage 3 of the Medicare and Medicaid EHR Incentive Programs and MIPS, which include heightened requirements for sharing electronic health information with other providers and with patients. Finally, we noted that effective surveillance and direct review of certified EHR technology is necessary if health care providers are to be able to rely on certifications issued under the ONC Health IT Certification Program as the basis for selecting appropriate technologies and capabilities that support the use of certified EHR technology while avoiding potential implementation and performance issues (81 FR 28170-28171).

For all of these reasons, the effective surveillance and direct review of certified health IT, and certified EHR technology as it applies to providers covered by this provision, provide greater assurance to health care providers that their certified EHR technology will perform in a manner that meets their expectations and that will enable them to demonstrate that they are using certified EHR technology in a meaningful manner as required by sections 1848(o)(2)(A)(i) and 1886(n)(3)(A)(i) of the Act. We stressed in the proposed rule (81 FR 28170-28171), however, that such surveillance and direct review will not be effective unless health care providers are actively engaged and cooperate with these activities, including by granting access to and assisting ONC-ACBs and ONC to observe the performance of production systems (see also the 2015 Edition final rule at 80 FR 62716).

Accordingly, we proposed that as part of demonstrating the use of certified EHR technology in a meaningful manner, a health care provider must demonstrate its good faith cooperation with authorized surveillance and direct review. We proposed to revise the definition of a meaningful EHR user at § 495.4 as well as the attestation requirements at § 495.40(a)(2)(i)(H) and § 495.40(b)(2)(i)(H) to require EPs, eligible hospitals, and CAHs to attest their cooperation with certain authorized health IT surveillance and direct review activities as part of demonstrating meaningful use under the Medicare and Medicaid EHR Incentive Programs. Similarly, we proposed to include an identical attestation requirement in the submission requirements for MIPS eligible clinicians under the advancing care information performance category proposed at § 414.1375.

We proposed that health care providers would be required to attest that they have cooperated in good faith with the authorized ONC-ACB surveillance and ONC direct review of their health IT certified under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT. Under the terms of the attestation, we stated that such cooperation would include responding in a timely manner and in good faith to requests for information (for example, telephone inquiries and written surveys) about the performance of the certified EHR technology capabilities in use by the provider in the field (81 FR 28170 through 28171). It would also include accommodating requests (from ONC-ACBs or from ONC) for access to the provider's certified EHR technology (and data stored in such certified EHR technology) as deployed by the health care provider in its production environment, for the purpose of carrying out authorized surveillance or direct review, and to demonstrate capabilities and other aspects of the technology that are the focus of such efforts, to the extent that doing so would not compromise patient care or be unduly burdensome for the health care provider.

We stated that the proposed attestation would support providers in meeting the requirements for the meaningful use of certified EHR technology while at the same time minimizing burdens for health care providers and patients (81 FR 28170 through 28171). We requested public comment on this proposal.

Through public forums, listening sessions, and correspondence received by CMS and ONC, and through the methods available for health care providers to submit 2 technical concerns related to the function of their certified EHR technology, we have received requests that ONC and CMS assist providers in mitigating issues with the performance of their technology, Start Printed Page 77021including issues that relate to the safety and interoperability of health IT. Our proposal was designed to help health care providers with these very issues by strengthening participation in surveillance and direct review activities that help assure that their certified EHR technology performs as intended. However, the comments we have received, and which we discuss below, suggest that the support that the policy provides for health IT performance was not understood by some stakeholders. For this reason, we are adopting a modification to the title and language describing this policy in this final rule with comment period to reflect the intent articulated in the proposed rule and to be responsive to the concerns raised by commenters.

As we have explained, our proposal to require that health care providers cooperate with ONC-ACB surveillance of certified health IT and ONC direct review of certified health IT reflects the need to address technical issues with the functionality of certified EHR technology and to support health care providers with the performance of their certified EHR technology. By cooperating with these activities, health care providers would assist ONC-ACBs and ONC in working with health IT developers to identify and rectify problems and issues with their technology. In addition, a health care provider who assists an ONC-ACB or ONC with these activities is also indirectly supporting other health care providers, interoperability goals, and the health IT infrastructure by helping to ensure the integrity and efficacy of certified health IT products in health care settings. To more clearly and accurately communicate the context and role of health care providers in these activities, and consistent with our approach to clarifying terminology and references, we have adopted new terminology in this final rule with comment period that focuses on the requirements for the health care provider rather than ONC or ONC-ACB actions and processes. In this section, the activities to be engaged in by health care providers in cooperation with ONC direct review or ONC-ACB surveillance are intended to support health care providers with the performance of certified EHR technology. We therefore use the phrase “Supporting Providers with the Performance of Certified EHR technology activities” (hereinafter referred to as “SPPC activities”) to refer to a health care provider's actions related to cooperating in good faith with ONC-ACB authorized surveillance and, separately or collectively as the context requires, a health care provider's actions in cooperating in good faith with ONC direct review.

Notwithstanding the terminology used in this final rule with comment period, and to avoid any confusion for health care providers engaging with ONC-ACBs or ONC in the future, we note that, when communicating with health care providers about the surveillance or direct review of certified health IT, ONC-ACBs and ONC will use the terminology in the 2015 Edition final rule, the ONC Enhanced Oversight and Accountability final rule, or other relevant ONC rulemakings and regulations, if applicable. In particular, a request for cooperation made by an ONC-ACB to a health care provider will not refer to “SPPC activities.” Rather, the request will typically refer to the ONC-ACB's need to carry out “surveillance” of the certified health IT used by the health care provider. Similarly, if ONC requests the cooperation of a health care provider in connection with ONC's direct review of certified health IT, as described in the ONC Enhanced Oversight and Accountability final rule scheduled for publication in the Federal Register on October 19, 2016, ONC will not use the terminology “SPPC activities.” Rather, ONC will request the cooperation of the health care provider with ONC's “direct review” or “review” of the certified health IT. In addition, throughout this final rule with comment period, we use the term “health IT vendor” to refer to third party entities supporting providers with technology requirements for the Quality Payment Program. In this section, we instead use the term “health IT developer” to distinguish between these third parties and those developers of a health IT product under the ONC rules. In order to maintain consistency with the ONC rules, we use the term “health IT developer” for those that have presented a health IT product to ONC for certification.

We received public comment on the proposals and our response follows.

Comment: Several commenters expressed concern that the proposed attestation would be unduly burdensome for health care providers. A number of commenters stated that requiring health care providers to engage in SPPC activities related to their certified EHR technology would place a disproportionate burden on providers relative to other stakeholders who share the responsibility of advancing the use of health IT and the exchange of electronic health information. More specifically, several commenters stated that SPPC activities related to a provider's certified EHR technology could disrupt health care operations. According to one commenter, this disruption may be especially burdensome for small practices who may need to engage a third party to assist them in cooperating in good faith to a request to assist ONC or an ONC-ACB, such as evaluating the performance of certified EHR technology capabilities in the field. Another commenter requested clarification on how evaluations of certified EHR technology would be conducted in production environments without disturbing patient encounters and clinical workflows.

Commenters offered a number of suggestions to reduce the potential burden of this proposal on health care providers. First, some commenters strongly endorsed the safeguards established by ONC—including methods used to select locations, such as sampling and weighting considerations and the exclusion of certain locations in appropriate circumstances. In addition, one commenter recommended that, where ONC-ACB surveillance or ONC direct review involves evaluating certified EHR technology in the field, the ONC-ACB surveillance or ONC direct review should be scheduled 30 days in advance and at a time that is convenient to accommodate the health care providers' schedules, such as after hours or on weekends. The commenter suggested that this would avoid disruption both to administrative operations and patient care.

Response: We understand that, if a request to assist ONC or an ONC-ACB is received, cooperating in good faith may require providers to prioritize limited time and other resources—especially for in-the-field evaluations of certified EHR technology. As we explained in the proposed rule, we believe that several safeguards established by ONC will minimize the burden of these activities (81 FR 28171). We note that under the 2015 Edition final rule, randomized surveillance is limited annually to 2 percent of unique certified health IT products (80 FR 62714). To illustrate the potential impact of these activities, for CY 2016 ONC estimates that up to approximately 24 products would be selected by each of its three ONC-ACBs, for a maximum of 72 total products selected across all ONC-ACBs (80 FR 62714). While ONC-ACB surveillance may be carried out at one or more locations for each product selected, we believe the likelihood that a health care provider will be asked to participate in the ONC-ACB surveillance of that product will in many cases be quite small due to the Start Printed Page 77022number of other health care providers using the health IT product. Further, the 2015 Edition final rule states that ONC-ACBs may use appropriate sampling methodologies to minimize disruption to any individual or class of health care providers and to maximize the value and impact of randomized surveillance for all health care providers and stakeholders (80 FR 62715). In addition, we reiterate that if an ONC-ACB is unable to complete its randomized surveillance of certified EHR technology at a particular location—such as where, despite a good faith effort, the health care provider at a chosen location is unable to provide the requisite cooperation—the ONC-ACB may exclude the location and substitute a different location for observation (see ONC 2015 Edition final rule 80 FR 62716). ONC has also explained that in many cases in-the-field evaluations of certified EHR technology may be accomplished through an in-person site visit or may instead be accomplished remotely (80 FR 62708). Thus, in general, we expect that health care providers will be presented with a choice of evaluation approaches and be able to choose one that is convenient for their practice.

We also understand the concerns expressed by some commenters that engaging in SPPC activities should not unreasonably disrupt the workflow or operations of a health care provider. In consultation with ONC, we expect that in most cases ONC and ONC-ACBs will accommodate providers' schedules and other circumstances, and that in most cases providers will be given ample notice of and time to respond to requests from ONC and ONC-ACBs. We note that in some cases it may be necessary to secure a health care provider's cooperation relatively quickly, such as if a potential problem or issue with certified EHR technology poses potentially serious risks to public health or safety (see the ONC Enhanced Oversight and Accountability final rule scheduled for publication in the Federal Register on October 19, 2016).

Finally, through public comment on the proposed rule, we note that in addition to these specific concerns expressed and addressed regarding SPPC activities, stakeholders share a general concern over the risks and potential negative impact of transitioning to MIPS and upgrading certified health IT in a short time without adequate preparation and support. Stakeholders are particularly concerned about this impact on solo practitioners, small practices, and health care providers with limited resources that may be providing vital access to health care in under-served communities. As noted previously, we believe the safeguards and policies established for ONC-ACBs' activities, discussed above, mitigate the risk of disruption to health care providers under normal circumstances. However, consistent with our overall approach for implementing new programs and requirements such as the Quality Payment Program and historically under the EHR Incentive Programs, we are modifying our final policy from the proposal to allow for additional flexibility for health care providers.

Our proposed policy would require health care providers to attest that they cooperated in good faith with ONC-ACB surveillance and ONC's direct review of certified health IT in order to demonstrate they have used certified EHR technology in a meaningful manner. In this final rule with comment period, we are finalizing a modified approach that splits the SPPC activities into two parts and draws a distinction between cooperation with ONC direct review and cooperation with ONC-ACB surveillance requests.

We are finalizing as proposed the requirement to cooperate in good faith with a request relating to ONC direct review of certified health IT. We do not believe it is appropriate to modify this requirement because ONC direct review is designed to mitigate potentially serious risk to public health and safety and to address practical challenges in reviewing certified health IT by an ONC-ACB. However, we are finalizing a modification to the requirement to cooperate with a request relating to ONC-ACB surveillance, which is different from ONC direct review (see discussion above). The modification to ONC-ACB surveillance will allow providers to choose whether to participate in SPPC activities supporting ONC-ACB surveillance of certified EHR technology.

As described in this section, ONC direct review focuses on situations involving (1) public health and safety and (2) practical challenges for ONC-ACBs, such as when a situation exceeds an ONC-ACB's resources or expertise. We maintain that cooperation in ONC direct review, when applicable, is important to demonstrating that a health care provider used certified EHR technology in a meaningful manner as required by sections 1848(o)(2)(A)(i) and 1886(n)(3)(A)(i) of the Act as stated in the proposed rule (81 FR 28170 through 28171).

We are therefore finalizing a two part attestation that splits the SPPC activities. As it relates to ONC direct review, the attestation is required. As it relates to ONC-ACB surveillance, the attestation is optional. The attestations are as follows:

  • Health care providers must attest that they engaged in good faith in SPPC activities related to ONC direct review by: (1) Attesting their acknowledgment of the requirement to cooperate in good faith with ONC direct review of their health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC direct review is received; and (2) if a request is received, attesting that they cooperated in good faith in ONC direct review of health IT under the ONC Health IT Certification Program to the extent that such technology meets (or can be used to meet) the definition of certified EHR technology.
  • Optionally, health care providers may attest that they engaged in good faith in SPPC activities related to ONC-ACB surveillance by: (1) Attesting their acknowledgement of the option to cooperate in good faith with ONC-ACB surveillance of their health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC-ACB surveillance is received; and (2) if a request is received, attesting that they cooperated in good faith in ONC-ACB surveillance of health IT under the ONC Health IT Certification Program, to the extent that such technology meets (or can be used to meet) the definition of certified EHR technology.

As noted previously, only a small percentage of providers are likely to receive a request for assistance from ONC or an ONC-ACB in a given year. Therefore under this final policy, for both the mandatory attestation and for the optional attestation, a health care provider is considered to be engaging in SPPC activities related to supporting providers with the performance of certified EHR technology first by an attestation of acknowledgment of the policy and second by an attestation of cooperation in good faith if a request to assist was received from ONC or an ONC-ACB. However, we reiterate that the attestation requirement as it pertains to cooperation with ONC-ACB surveillance is optional for health care providers.

Operationally, we expect that the submission method selected by the health care provider will influence how these attestations are accomplished (see section II.E.5.a on MIPS submission mechanisms for details or the 2015 EHR Incentive Programs final rule (80 FR 62896-62901). For example, a Medicaid EP attesting to their state for the EHR Incentive Programs may be provided a series of statements within the Start Printed Page 77023attestations system. In this case the attestation would be offered in two parts. For the first part, in order to successfully demonstrate meaningful use, the EP must attest that they engaged in SPPC activities related to ONC direct review of certified EHR technology, first by their acknowledgement of the policy, and second by attesting that they cooperated in good faith with ONC direct review of the certified EHR technology if a request to assist was received. For the second part in this example, the Medicaid EP may choose to attest that they engaged in SPPC activities related to ONC-ACB surveillance of certified EHR technology, including attesting to having cooperated in good faith if a request to assist was received, or the EP may choose not to so attest.

A health care provider electronically submitting data for MIPS would be required to use the form and manner specified for the submission mechanism to indicate their attestation to the first part, and may indicate their attestation to the second part if they so choose. CMS and ONC will also offer continued support and guidance both through educational resources to support participating in and reporting to CMS programs, and through specific guidance for those health care providers who receive requests related to engaging in SPPC activities.

Comment: Several commenters opposed any in-the-field observation of a health care provider's certified EHR technology and insisted that such observations be conducted with the developer of the certified EHR technology instead. Some commenters questioned the need to perform observations of certified EHR technology in production environments, observing that health care providers and other users of certified EHR technology often depend on the developer of the certified EHR technology to deliver required functionality and capabilities. One commenter recommended that the observation of certified EHR technology be limited to the use of test systems and test data rather than observation of production systems and data.

Several commenters stated that health care providers should not be required to cooperate with on-premises observation of their certified EHR technology because an ONC-ACB should be able to access and evaluate the performance of certified health IT capabilities using remote access methods. By contrast, other commenters stated that remote observation could create security risks and that all observations should be conducted on the premises, preferably under the direction of the health care provider's clinical staff.

Response: To provide adequate assurance that certified EHR technology meets applicable certification requirements and provides the capabilities health care providers need, it is critical to determine not only how certified EHR technology performs in a controlled testing environment but also how it performs in the field. Indeed, a fundamental purpose of ONC-ACB surveillance and ONC direct review is to allow ONC-ACBs and ONC to identify problems or deficiencies in certified EHR technology that may only become apparent once the technology has been implemented and is in use by health care providers in production environments (80 FR 62709). These activities necessarily require the cooperation of the clinicians and other persons who actually use the capabilities of certified EHR technology implemented in production environments, including health care providers. (See 81 FR 28170-71). This cooperation ultimately benefits health care providers and is critical to provider success in the Medicare and Medicaid EHR Incentive Programs and MIPS because it provides confidence that certified EHR technology capabilities will function as expected and that health care providers will be able to demonstrate compliance with CMS program requirements.

We decline to limit health care providers' engagement in SPPC activities to any particular form of observation, such as on-premises or remote observation of certified capabilities. We note that in the 2015 Edition final rule, ONC explained the observation of certified health IT capabilities in a production environment may require a variety of methodologies and approaches (80 FR 62709). In addition, as the comments suggest, individual health care providers are likely to have different preferences and should have the flexibility to work with an ONC-ACB or ONC to identify an approach to these activities that is most effective and convenient. In this connection, we have consulted with ONC and expect that, where feasible, a health care provider's preference for a particular form of observation will be accommodated.

For similar reasons, we decline to limit engagement in SPPC activities to the use of test systems or test data. The use of test systems and test data may be allowed in some circumstances, but may not be appropriate in all circumstances. For example, a problem with certified EHR technology capabilities may be difficult or impossible to replicate with test systems or test data. More fundamentally, limiting cooperation to observations of test systems and test data may not provide the same degree of assurance that certified EHR technology used by health care providers (for example, production systems used with production data) continue to meet applicable certification requirements and function in a manner that supports health care providers participation in the EHR Incentive Programs and MIPS.

Comment: One commenter suggested that health care providers who engage in SPPC activities be able to file a formal complaint with ONC or CMS in the event that the ONC-ACB were to “handle matters inappropriately,” and that the ONC-ACB should not be permitted to continue its activities until the complaint has been resolved.

Response: If a provider has any concerns about the propriety of an ONC-ACB's conduct, including in connection with a request to assist in ONC-ACB surveillance of certified health IT or during in-the-field surveillance of the certified EHR technology, the health care provider should make a formal complaint to ONC detailing the conduct in question. For further information, we direct readers to ONC's Web site: https://www.healthit.gov/​healthitcomplaints.

Comment: A number of commenters were opposed to or raised concerns regarding this proposal on the grounds that requiring health care providers to engage in SPPC activities would violate the HIPAA Rules. Relatedly, a number of commenters stated that requiring providers to give ONC or ONC-ACBs access to their production systems may be inconsistent with a health care organization's privacy or security policies and could introduce security risks. A few commenters stated that observation of certified EHR technology in the field would violate patients' or providers' privacy rights or expectations. Some of these commenters expressed the view that any requirement to engage in SPPC activities would be an unjustified governmental invasion of privacy or other interests.

Response: As noted in the Quality Payment Program proposed rule and in the 2015 Edition final rule, in consultation with the Office for Civil Rights, ONC has clarified that as a result of ONC's health oversight authority a health care provider is permitted, without patient authorization, to disclose PHI to an ONC-ACB or directly to ONC for purposes of engaging in SPPC activities in cooperation with a request to assist from ONC or an ONC-ACB (81 FR 28171; 80 FR 62716). Health Start Printed Page 77024care providers are permitted without patient authorization to make disclosures to a health oversight authority (as defined in 45 CFR 164.501) for oversight activities authorized by law (as described in 45 CFR 164.512(d)), including activities to determine compliance with program standards, and ONC may delegate its authority to ONC-ACBs to perform surveillance of certified health IT under the Program.[3] This disclosure of PHI to an ONC-ACB does not require a business associate agreement with the ONC-ACB since the ONC-ACB is not performing a function on behalf of the covered entity. In the same way, a provider, health IT developer, or other person or entity is permitted to disclose PHI directly to ONC, without patient authorization and without a business associate agreement, for purposes of ONC's direct review of certified health IT or the performance of any other oversight responsibilities of ONC to determine compliance under the Program.

We disagree with commenters who maintained that the disclosure of PHI to ONC or an ONC-ACB could be inconsistent with reasonable privacy or other organizational policies or would otherwise be an unjustified invasion of privacy or any other interest. As noted, the disclosure of this information would be authorized by law on the basis that it is a disclosure to a health oversight agency (ONC) for the purpose of determining compliance with a federal program (the ONC Health IT Certification Program). In addition, we note that any further disclosure of PHI by an ONC-ACB or ONC would be limited to disclosures authorized by law, such as under the federal Privacy Act of 1974, or the Freedom of Information Act (FOIA), as applicable.

Comment: Several commenters requested clarification concerning the types of production data that ONC or an ONC-ACB would be permitted to access (and that a health care provider would make accessible to ONC, or the ONC-ACB) when assessing certified EHR technology in a production environment. Several commenters recommended that production data be limited to the certified capabilities and not extend to other aspects of the health IT.

Response: A request to assist in ONC-ACB surveillance or ONC direct review may include in-the-field surveillance or direct review of the certified EHR technology to determine whether the capabilities of the health IT are functioning in accordance with the requirements of the ONC Health IT Certification Program. We note that it is common for certified EHR technology to be deployed and integrated with other technologies (including technologies that produce data used across multiple systems and components). Therefore, we believe it is feasible that determining whether certified EHR technology is operating as it should could mean, for example, ONC reviewing whether the certified EHR technology does not operate as it should when it interacts with other technologies. We also refer commenters to the 2015 Edition final rule and the ONC Enhanced Oversight and Accountability final rule for more information about the scope of ONC-ACB surveillance and ONC direct review, and for a discussion about the types of capabilities that may be subject to ONC-ACB surveillance and ONC direct review.

Comment: A commenter observed that while the proposed attestation would be retrospective, health care providers may be unaware of the requirement to engage in SPPC activities until they are presented with the attestation statement. The commenter suggested that health care providers be required to attest only that they will prospectively engage in SPPC activities.

Response: The attestation is retrospective because it is part of health care provider's demonstration that it has used certified EHR technology in a meaningful manner for a certain period. Based on our consultation with ONC, the health care providers will be made aware of both their obligation to cooperate if they are contacted to assist in ONC direct review of certified health IT and their option to cooperate if they are contacted to assist an ONC-ACB in surveillance of certified health IT. Thus, we believe that health care providers will be able to appropriately engage in SPPC activities for CMS programs and attest to their cooperation.

Comment: A commenter urged that health care providers be held harmless if engagement in SPPC activities results in a finding that their certified EHR technology no longer conforms to the requirements of the ONC Health IT Certification Program due to the actions of the certified EHR technology developer.

Response: ONB-ACB surveillance and ONC direct review provide an opportunity to assess the performance of certified EHR technology capabilities in a production environment to determine whether the technology continues to perform in accordance with the requirements of the ONC Health IT Certification Program. This analysis will necessarily be focused on the performance of the technology, which may require the consideration of a provider's use of the technology. However, health care providers that cooperate with the analysis of the performance of certified EHR technology are not themselves subject to ONC or an ONC-ACB's authority under, as applicable, the surveillance requirements of the 2015 Edition final rule, or the direct review requirements of the ONC Enhanced Oversight and Accountability final rule. As such, no adverse finding or determination can be made by ONC or an ONC-ACB against a provider in connection with ONC direct review or ONC-ACB surveillance. If ONC or an ONC-ACB determined that the performance issue being analyzed arose solely from the provider's use of the technology and not from a problem with the technology itself, ONC or an ONC-ACB would not make a nonconformity finding against the health IT, but may decide to notify the provider of its determination for information purposes only. We do acknowledge, however, that if in the course of ONC-ACB surveillance or ONC direct review, ONC became aware of a violation of law or other requirements, ONC could share that information with relevant federal or state entities. If a certified health IT product is determined to no longer conform with the requirements of the ONC Health IT Certification Program and the health IT's certification were to be terminated by ONC or withdrawn by an ONC-ACB, there exists a process by which an affected health care provider may apply for exception from payment adjustments related to CMS programs on the basis of significant hardship or exclusion from the requirement. For example, we direct readers to CMS FAQ# 12657 [4] related to hardship exceptions for the EHR Incentive Programs related to the certification of a health IT product being terminated or withdrawn.

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

Response: We have considered the commenters' suggestion but conclude Start Printed Page 77025that it would be impracticable for two main reasons. First, a key component of the oversight of certified EHR technology is the randomized surveillance of certified EHR technology by ONC-ACBs. To ensure a representative sample, we believe it is important that all health care providers are required to use certified EHR technology as an EP, eligible hospital, or CAH under the Medicare and Medicaid EHR Incentive Programs and as a MIPS eligible clinicians under the advancing care information performance category be part of the pool from which ONC-ACBs select locations for in-the-field surveillance, not only those who volunteer for participation. Second, as we explained in connection with commenters' concerns regarding the potential impact of SPPC activities on providers, we anticipate that the opportunity for health care providers to participate in randomized surveillance of their certified EHR technology will arise relatively infrequently due to the relatively small number of practices and other locations that would be selected for this type of ONC-ACB surveillance. This means that only a limited number of health care providers would have an opportunity to participate in this way for reasons outside the control of the health care provider. Consequently, health care providers would not have an equal opportunity to participate in these activities, which would make adopting an incentive within the scoring methodology for these activities potentially unfair to providers who are participating in CMS programs but are not selected by the randomized selection process. This would unfairly skew scores in a manner unrelated to a health care provider's performance in a given program. For these reasons we decline to adopt such an arrangement.

Comment: Multiple commenters stated that this proposal was premature because ONC has yet to finalize the ONC Health IT Certification Program: Enhanced Oversight and Accountability proposed rule. Commenters urged us to withdraw the proposal until such time as any changes to the ONC Health IT Certification Program have been finalized.

Response: We recognize that the pendency of the ONC Health IT Certification Program: Enhanced Oversight and Accountability proposed rule, which outlines the policies for ONC direct review of certified health IT, at the time of our proposal may have been challenging for some commenters. However, health care provider engagement in SPPC activities is important regardless of whether a request to assist relates to ONC direct review of certified health IT or ONC-ACB surveillance of certified health IT. As we have explained, we expect health care providers will engage in SPPC activities because doing so is fundamental to ensuring that certified EHR technology performs in a manner that supports the goals of health care providers seeking to meet the requirements of the MIPS and Medicare and Medicaid EHR Incentive Programs. We further believe that the publication of the ONC Enhanced Oversight and Accountability final rule in concert with the flexibilities finalized in this final rule with comment period, as well as the timeline for implementation of these policies, which apply to reporting periods beginning in CY 2017, supports resolution of this concern.

Comment: A commenter stated that the proposed attestation would compel meaningful EHR users to cooperate with far-ranging or unbounded inquiries into their certified health IT. Other commenters expressed similar concerns and pointed to what they perceived as the broad range of issues that could be subject to ONC's direct review under the ONC Health IT Certification Program: Enhanced Oversight and Accountability proposed rule.

Response: We reiterate that, whatever form engagement in SPPC activities may take, any conclusions by ONC or ONC-ACBs will necessarily be focused on the performance of the technology. Moreover, as we have explained, health care providers will only be required to attest their engagement in SPPC activities in relation to requests received to assist in ONC direct review of certified capabilities of their health IT that meet (or can be used to meet) the definition of certified EHR technology. Further, because a health care provider's attestation will be retrospective as noted previously, the attestation relates only to acknowledgment if no request was received or the health care provider's cooperation with requests for assistance that have already been received at the time of making the attestation. The attestation requirement does not require that health care providers commit to engaging in unknown future activities.

Comment: A commenter requested more information about the circumstances that would trigger direct review of certified EHR technology. Separately, the commenter recommended that such review be conducted only as part of an audit of a health care provider's demonstration of meaningful use or an eligible clinician's reporting for the advancing care information performance category.

Response: ONC determines the requirements for and circumstances under which health IT may be subject to ONC-ACB surveillance or ONC direct review under the ONC Health IT Certification Program. We refer the commenter to the 2015 Edition final rule (80 FR 62601) for a discussion of existing requirements related to the observation of certified health IT by ONC-ACBs and to the ONC Enhanced Oversight and Accountability final rule (scheduled for publication in the Federal Register on October 19, 2016) for a discussion of ONC's direct review activities. To, be effective, ONC-ACB surveillance or ONC direct review of SPPC activities must be timely to identify an issue with the certified health IT. If these actions are limited to the timing of retrospective audits of a health care provider's compliance with program requirements, they may not reflect the current implementation of the technology in a production setting where the issue exists. For these reasons, it is not appropriate for a health care provider's cooperation to be limited to the context of a program audit on prior participation.

Comment: To assist health care providers in complying with the proposed attestation, a commenter recommended that any requests for engagement in SPPC activities be clearly labeled as such so as to differentiate them from other types of communications.

Response: We acknowledge this commenter's concern that, to support health care providers engaging in SPPC activities, a request to assist should be designed to clearly inform the recipient as to the purpose of the communication and avoid, as much as possible, the request being inadvertently overlooked or unnoticed. We have consulted with ONC and clarify that ONC-ACBs currently initiate contact with health care providers for randomized surveillance by emailing the person or office holder of a practice or organization that is the primary contact for the health IT developer whose product is being surveilled or reviewed. The contact information is supplied by the developer, and ONC-ACBs would not ordinarily contact a health care provider directly unless they are identified by the developer as being the most appropriate point of contact for a practice location. However, we note that in addition to clarity on the point of contact, clarity within the request itself is essential for the health care provider engaging in SPPC activities. This relates not only to clarity as to the purpose of the request, but also in relation to the mandatory and optional SPPC activities which are differentiated based on if the request is for ONC direct review of Start Printed Page 77026certified health IT or ONC-ACB surveillance of certified health IT.

As program guidance is developed, CMS and ONC will work to ensure that requests from ONC and ONC-ACBs provide clear context and guidance for health care providers when requesting that health care providers engage in SPPC activities as part of their participation in CMS programs.

Comment: A commenter stated that some EHR contracts specifically prohibit customers or users of certified EHR technology from providing ONC or ONC-ACBs with access to the technology or data.

Response: Developers of certified health IT are required to cooperate with ONC program activities such as ONC direct review or ONC-ACB surveillance of certified health IT, which includes furnishing information to ONC or an ONC-ACB that is necessary to the performance of these activities (see 80 FR 62716-18) in order to obtain and maintain certification of health IT. Access to certified health IT that is under observation by ONC or an ONC-ACB, together with production data relevant to the certified capability or capabilities being assessed, is essential to this process. For example, in the 2015 Edition final rule, ONC stated that a health IT developer must furnish to the ONC-ACB upon request, accurate and complete customer lists, user lists, and other information that the ONC-ACB determines is necessary to enable it to carry out its surveillance responsibilities (80 FR 62716). If a health care provider reasonably believes that it is unable to engage in SPPC activities due to these or other actions of its health IT developer, the health care provider should notify ONC or the ONC-ACB, as applicable. If the developer has indeed limited, discouraged, or prevented the health care provider from cooperation in good faith with a request to assist ONC direct review, the health care provider would not be required to cooperate with such activities unless and until the developer removed the contractual restrictions or other impediments.

Comment: A commenter expressed concern about sharing data with ONC or an ONC-ACB without a clear description of the data to be accessed.

Response: The nature of the data that will need to be accessed by ONC or an ONC-ACB will be made clear to the health care provider at the time that their cooperation is sought. To alleviate any concerns commenters may have, we will work with ONC to provide guidance to ONC-ACBs and to providers, as necessary, to address issues such as the communication protocols to be used when requesting a health care provider's engagement in SPPC activities.

Comment: Several commenters requested additional guidance on specific actions health care providers would be expected to take to engage in SPPC activities and cooperate in good faith with a request to assist if so requested. One commenter recommended that CMS and ONC create a check-list tool that clinicians could use to track their compliance with the required activities.

Response: As specified in the proposed rule, engaging in SPPC activities and cooperation in good faith may simply require the provision of information, such as in response to telephone inquiries and written surveys, about the performance of the certified EHR technology being used. Engagement in SPPC activities and cooperation in good faith might also involve facilitating requests (from ONC or ONC-ACBs) for access to the certified EHR technology (and related data) as deployed in the provider's production environment and to demonstrate capabilities and other aspects of the technology that are the focus of the ONC-ACB surveillance or ONC direct review.

Because assistance with ONC-ACB surveillance or ONC direct review will typically be carried out at a practice or facility level, we expect that it will be rare for a health care provider to be directly involved in the conduct of many of these activities, including in-the-field observations of certified EHR technology capabilities. To comply with the attestation requirements, a health care provider should establish to their own satisfaction that appropriate processes and policies are in place in their practice to ensure that all relevant personnel, such as a practice manager or IT officer, are aware of the health care provider's obligation to engage in SPPC activities related to requests to assist in ONC direct review of certified health IT and the health care provider's option to engage in SPPC activities related to requests to assist in ONC-ACB surveillance of certified health IT. This includes understanding the requirement to cooperate in good faith with a request to assist in ONC direct review if received. Health care providers should also ensure that appropriate processes and policies are in place for the practice to document all requests and communications concerning SPPC activities as they would for other requirements of CMS programs in which they participate. We note that for a health care provider participating in a CMS program as an individual, if that health care provider practices at multiple locations or switches locations throughout the course of a year, they would only need to make inquiries about any requests to assist in ONC direct review of certified health IT during the period in which the eligible clinician or EP worked at the practice.

We acknowledge the commenter's desire for a checklist tool to provide greater certainty for clinicians. However, as ONC explained in the 2015 Edition final rule, an evaluation of certified health IT in a production environment may require a variety of methodologies and approaches (80 FR 62709) and individual health care providers are able to express different preferences and should have the flexibility to work with ONC or an ONC-ACB to identify an effective approach that is most convenient. Because the specific actions required will be addressed on a case-by-case basis, the development of a checklist tool may not be feasible. Rather, as noted previously, if any request is made, ONC or an ONC-ACB will work directly with the health care provider to provide clear guidance on the actions needed to assist in the request. The health care provider would then retain any such documentation concerning the request for their records as they would for other similar requirements in CMS programs.

Comment: A commenter asked how ONC-ACBs will identify themselves and how a health care provider will be able to verify that it is not dealing with an imposter.

Response: Each health IT developer contracts with one or more ONC-ACBs to provide certification services. As such, health IT developers should be familiar with the processes used by their ONC-ACB(s) and have existing practices for communicating with the personnel of their ONC-ACB(s). A health care provider can, on receipt of a request to assist an ONC-ACB, contact their health IT developer and request information about the identity of the ONC-ACB personnel that will carry out the activities. Health care providers should, before providing access to their facility or the certified health IT, request that the ONC-ACB personnel provide appropriate identification that matches the information about the ONC-ACB provided by the provider's certified health IT developer.

Comment: Several commenters requested that we elaborate on the requirements for engaging in SPPC activities “in good faith” and for permitting timely access to certified EHR technology.

Response: Health care providers are required to attest to engaging in SPPC Start Printed Page 77027activities which requires that they cooperate in good faith and in a timely manner with a request to assist in ONC direct review of certified health IT if such a request is received. A health care provider may also optionally attest to engaging in SPPC activities, including having cooperated in good faith, in response to a request to assist an ONC-ACB with surveillance of certified health IT. This includes cooperating in a manner that aids and assists ONC or an ONC-ACB to perform ONC direct review or ONC-ACB surveillance activities to the extent that such cooperation is practicable and not unduly burdensome to the provider. As previously mentioned, the particular needs of any request for assistance from ONC or an ONC-ACB may vary depending on a wide range of factors. In addition, “in good faith” is necessarily dependent upon the particular facts and circumstances of the health care provider who attests. For example, a request for assistance may relate to a capability the health care provider does not have enabled in their EHR as it is not needed for their unique practice, which might be costly, time consuming, or otherwise unreasonable for the provider to enable solely for the purposes of ONC direct review of that function. In such a case, the health care provider who communicates these limitations to ONC, and maintains documentations of the request and these circumstances related to their practice, may be found to have cooperated in good faith based on this documentation. However, if the health care provider received such a request and provided no response to the request and did not retain documentation of these circumstances, they may be found not to have cooperated in good faith.

Comment: One commenter asked us to clarify that a health care provider will have satisfied the requirements of the proposed attestation in the event that the health care provider was never approached by ONC or an ONC-ACB with a request for assistance during the relevant reporting period.

Response: In the circumstances the commenter describes, the health care provider would be able to attest to both the mandatory attestation (related to ONC direct review) and the optional attestation (related to ONC-ACB surveillance) on the basis that they acknowledge the policy. In other words, for the mandatory attestation, the health care provider that receives no request related to ONC direct review could successfully meet the attestation requirement by attesting that they acknowledge the requirement to cooperate in good faith with all requests for assistance with ONC direct review of their certified EHR technology. Likewise, a health care provider that did not receive a request for assistance with ONC-ACB surveillance during the reporting year but still seeks to attest to the optional attestation would attest that they are aware of the option to cooperate in good faith with all requests for assistance in ONC-ACB surveillance. We have revised the regulation text provisions at §§ 495.4, 495.40(a)(2)(i)(H), 495.40(b)(2)(i)(H), and 414.1375(b)(3)(i) to state that a health care provider engages in SPPC activities by cooperating in good faith with the ONC-ACB surveillance or ONC direct review of its certified EHR technology, to the extent that the health care provider receives a request from an ONC-ACB or ONC during the relevant reporting period; and that in the absence of any requests being made during the reporting period, the health care provider would demonstrate their engagement in the SPPC activities simply by attesting that they are aware of the SPPC policy.

Comment: Several commenters requested clarification regarding the documentation that would be required to demonstrate compliance with the terms of the attestation so that health care providers could plan and prepare for an audit of this requirement. Among other topics, commenters requested guidance on expected documentation requirements related to a health care provider's responsiveness to requests for engagement in SPPC activities and the extent of cooperation required.

Response: We acknowledge commenters' concerns about required documentation in cases of an audit. We clarify that we will provide guidance to auditors relating to this final rule with comment period and the attestation process in a similar manner as guidance is provided for other requirements under current CMS programs. This instruction includes requiring auditors to work closely with health care providers on identifying the appropriate supporting documentation applicable to the health care provider's individual case. We further stress that audit determinations are made on a case by case basis, which allows us to give individual consideration to each health care provider. We believe that such case-by-case review will allow us to adequately account for the varied circumstances that may be relevant.

Comment: Commenters requested clarification concerning the effective date of the attestation requirement and, more specifically, the period to which an attestation that a health care provider engaged in SPPC activities would apply. Several commenters expressed concerns related to the timing of the attestation, noting that health care providers may submit attestations for reporting periods that have already begun or that will have begun prior to the effective date of this final rule with comment period.

Response: We understand the commenters' concerns and are finalizing the requirement to attest to engagement in SPPC activities for health care providers for MIPS performance periods or EHR reporting periods beginning on or after January 1, 2017. The requirement includes only requests to engage in SPPC activities received after the effective date of this final rule with comment period. In other words, if a health care provider receives a request from ONC or an ONC-ACB to engage in SPPC activities before the effective date of this final rule with comment period, the attestation requirement will not apply to that request, and the health care provider is not required to cooperate with the request.

After review and consideration of public comment, we are finalizing revisions to the definition of a meaningful EHR user at §§ 495.4 and 414.1305 to include “engaging in activities related to supporting providers with the performance of certified EHR technology.”

We are finalizing modifications to the attestation requirements at § 495.40(a)(2)(i)(H) and (b)(2)(i)(H) to require an EP, eligible hospital or CAH to attest that they engaged in SPPC activities by attesting that they: (1) Acknowledge the requirement to cooperate in good faith with ONC direct review of their health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC direct review is received; and (2) if requested, cooperated in good faith with ONC direct review of their health information technology certified under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT, including by permitting timely access to such technology and demonstrating its capabilities as implemented and used by the EP, eligible hospital, or CAH in the field.

Additionally, we are finalizing that, optionally, the EP, eligible hospital, or CAH may also attest that they engaged in SPPC activities by attesting that they: (1) Acknowledge the option to cooperate in good faith with ONC-ACB surveillance of their health information technology certified under the ONC Health IT Certification Program if a Start Printed Page 77028request to assist in ONC-ACB surveillance is received; and (2) if requested, cooperated in good faith with ONC-ACB surveillance of their health information technology certified under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT, including by permitting timely access to such technology and demonstrating its capabilities as implemented and used by the EP, eligible hospital, or CAH in the field.

We are also finalizing at § 404.1375(3) that the same attestations be made by all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM scoring standard, as discussed in section II.E.5.h. of this final rule with comment period (see 81 FR 28170-71).

b. Support for Health Information Exchange and the Prevention of Information Blocking

To prevent actions that block the exchange of information, section 106(b)(2)(A) of the MACRA amended section 1848(o)(2)(A)(ii) of the Act to require that, to be a meaningful EHR user, an EP must demonstrate that he or she has not knowingly and willfully taken action (such as to disable functionality) to limit or restrict the compatibility or interoperability of certified EHR technology. Section 106(b)(2)(B) of MACRA made corresponding amendments to section 1886(n)(3)(A)(ii) of the Act for eligible hospitals and, by extension, under section 1814(l)(3) of the Act for CAHs. Sections 106(b)(2)(A) and (B) of the MACRA provide that the manner of this demonstration is to be through a process specified by the Secretary, such as the use of an attestation. Section 106(b)(2)(C) of the MACRA states that the demonstration requirements in these amendments shall apply to meaningful EHR users as of the date that is 1 year after the date of enactment, which would be April 16, 2016.

As legislative background, on December 16, 2014, in an explanatory statement accompanying the Consolidated and Further Continuing Appropriations Act,[5] the Congress advised ONC to take steps to “decertify products that proactively block the sharing of information because those practices frustrate congressional intent, devalue taxpayer investments in certified EHR technology, and make certified EHR technology less valuable and more burdensome for eligible hospitals and eligible providers to use.” [6] The Congress also requested a detailed report on health information blocking (referred to in this final rule with comment period as “the Information Blocking Report”). In the report, which was submitted to the Congress on April 10, 2015,[7] ONC concluded from its experience and available evidence that some persons and entities—including some health care providers—are knowingly and unreasonably interfering with the exchange or use of electronic health information in ways that limit its availability and use to improve health and health care.[8]

We explained in the proposed rule that the demonstration required by section 106(b)(2) of the MACRA must provide substantial assurance not only that certified EHR technology was connected in accordance with applicable standards during the relevant EHR reporting period, but that the health care provider acted in good faith to implement and use the certified EHR technology in a manner that supported and did not interfere with the electronic exchange of health information among health care providers and with patients to improve quality and promote care coordination (81 FR 28172). We proposed that such a demonstration be made through an attestation (referred to in this section of the preamble as the “information blocking attestation”), which would comprise three statements related to health information exchange and information blocking, which were described in the proposed rule (81 FR 28172). Accordingly, we proposed to revise the definition of a meaningful EHR user at § 495.4 and to revise the corresponding attestation requirements at § 495.40(a)(2)(i)(I) and (b)(2)(i)(I) to require this attestation for all EPs, eligible hospitals, and CAHs under the Medicare and Medicaid EHR Incentive Programs, beginning with attestations submitted on or after April 16, 2016. Further, we proposed this attestation requirement (at § 414.1375(b)(3)(ii)) for all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM scoring standard, as discussed in section II.E.5.h of the proposed rule (81 FR 28181).

We invited public comment on this proposal, including whether the proposed attestation statements could provide the Secretary with adequate assurances that an eligible clinician, EP, eligible hospital, or CAH has complied with the statutory requirements for information exchange. We also encouraged public comment on whether there are additional facts or circumstances to which eligible clinicians, EPs, eligible hospitals, and CAHs should be required to attest, or whether there is additional information that they should be required to report.

Comment: A number of commenters expressed strong support for this proposal and urged us to finalize the information blocking attestation as proposed. Commenters anticipated that such an attestation would discourage information blocking; encourage more robust sharing of information among all members of a patient's care team; increase demand for more open and interoperable health IT platforms and systems; and strengthen efforts to enhance health care quality and value, including the capturing and sharing of information about quality, costs, and outcomes. One commenter stated that the information blocking attestation would also help independent physicians compete by deterring predatory information sharing policies or practices, especially by large health systems or hospitals.

Many commenters expressed partial support for this proposal but voiced concerns about the particular content or form of the information blocking attestation as proposed. Several commenters stated that the language of the attestation was unclear and should provide more detail regarding the specific actions health care providers would be required to attest. Conversely, several commenters (including some of the same commenters) believe that the language of the attestation was too prescriptive. Some commenters recommended revising or removing one or more of the three statements that comprise the attestation. A few commenters suggested that we finalize only the first statement—which mirrors the statutory language in section 106(b)(2) of the MACRA—and contended that the other statements were unnecessary or, alternatively, go beyond what section 106(b)(2) requires.

Some commenters were opposed in principle to requiring health care Start Printed Page 77029providers to attest to any statement regarding information blocking. Most of these commenters insisted that such a requirement would impose unnecessary burdens or unfair obligations on health care providers, who, in the view of the commenters, are seldom responsible for information blocking.

The majority of commenters, whether they supported or opposed the proposal, stressed that certain factors that prevent interoperability and the ability to successfully exchange and use electronic health information are beyond the ability of a health care provider to control. Many of these commenters stated that EHR vendors should be required to submit an information blocking attestation because they have greater control over these factors and, in the experience of some commenters, are more likely to engage in information blocking.

Response: After consideration of the comments as well as the statutory provisions cited above, and in consultation with ONC, we believe the proposed attestation requirement is an appropriate and effective means to implement the demonstration required by section 106(b)(2) of the MACRA; we are therefore finalizing this requirement as proposed, as discussed in greater detail below and in our responses to specific comments that follow.

As many commenters recognized, the information blocking concerns expressed by Congress are serious and reflect a systemic problem: A growing body of evidence establishes that persons and entities—including some health care providers—have strong incentives to unreasonably interfere with the exchange and use of electronic health information, undermining federal programs and investments in the meaningful use of certified EHR technology to improve health and the delivery of care.[9] While effectively addressing this problem will require additional and more comprehensive measures,[10] section 106(b)(2) of the MACRA represents an important first step towards increasing accountability for certain types of information blocking in the specific context of meaningful EHR users.

The proposed information blocking attestation consists of three statements that contain several specific representations about a health care provider's implementation and use of certified EHR technology. These representations, taken together, will enable the Secretary to infer with reasonable confidence that the attesting health care provider acted in good faith to support the appropriate exchange of electronic health information and therefore did not knowingly and willfully limit or restrict the compatibility or interoperability of certified EHR technology.

We believe that this level of specificity is necessary and that a more generalized attestation would not provide the necessary assurances described above. This does not mean, however, that the information blocking attestation imposes unnecessary or unreasonable requirements on health care providers. To the contrary, we have carefully tailored the attestation to the demonstration required by section 106(b)(2) of the MACRA. In particular, the attestation focuses on whether a health care provider acted in good faith to implement and use certified EHR technology in a manner that supports interoperability and the appropriate exchange of electronic health information. Recognizing that a variety of factors may prevent the exchange or use of electronic health information, and consistent with the focus of section 106(b)(2) on actions that are knowing and willful, this good faith standard takes into account health care providers' individual circumstances and does not hold them accountable for consequences they cannot reasonably influence or control.

For these and the additional reasons set forth in our responses to comments immediately below, and subject to the clarifications therein, we are finalizing this attestation requirement as proposed.

Comment: A number of commenters, several of whom expressed support for our proposal, regarded the language of the attestation as quite broad and stated that additional guidance may be needed to enable health care providers to understand the actions they would be required to attest.

Response: We agree that health care providers must be able to understand and comply with program requirements. For this reason, the information blocking attestation consists of three statements related to health information exchange and the prevention of health information blocking. These statements—which we are finalizing at § 495.40(a)(2)(i)(I) for EPs, § 495.40(b)(2)(i)(I) for eligible hospitals and CAHs, and § 414.1375(b)(3)(ii) for eligible clinicians—contain specific representations about a health care provider's implementation and use of certified EHR technology. We believe that these statements, taken together, communicate with appropriate specificity the actions health care providers must attest to in order to Start Printed Page 77030demonstrate that they have complied with the requirements established by section 106(b)(2) of the MACRA. To provide further clarity, we set forth and explain each of these statements in turn below.

  • Statement 1: A health care provider must attest that it did not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of certified EHR technology.

This statement mirrors the language of section 106(b)(2) of the MACRA. We note that except for one illustrative example (concerning actions to disable functionality), the above statement does not contain specific guidance as to the types of actions that are likely to “limit or restrict” the compatibility or interoperability of certified EHR technology, nor the circumstances in which a health care provider who engages in such actions does so “knowingly and willfully.” The information blocking attestation supplements the foregoing statement with two more detailed statements concerning the specific actions a health care provider took to support interoperability and the exchange of electronic health information.

  • Statement 2: A health care provider must attest that it implemented technologies, standards, policies, practices, and agreements reasonably calculated to ensure, to the greatest extent practicable and permitted by law, that the certified EHR technology was, at all relevant times: (1) Connected in accordance with applicable law; (2) compliant with all standards applicable to the exchange of information, including the standards, implementation specifications, and certification criteria adopted at 45 CFR part 170; (3) implemented in a manner that allowed for timely access by patients to their electronic health information (including the ability to view, download, and transmit this information); and (4) implemented in a manner that allowed for the timely, secure, and trusted bi-directional exchange of structured electronic health information with other health care providers (as defined by 42 U.S.C. 300jj(3)), including unaffiliated health care providers, and with disparate certified EHR technology and vendors.

This statement focuses on the manner in which a health care provider implemented its certified EHR technology during the relevant reporting period, which is directly relevant to whether the health care provider took any actions to limit or restrict the compatibility or interoperability of the certified EHR technology. By attesting to this statement, a health care provider represents that it acted in good faith to implement its certified EHR technology in a manner that supported—and did not limit or restrict—access to and the exchange of electronic health information, to the extent that such access or exchange was appropriate (that is, practicable under the circumstances and authorized, permitted, or required by law). More specifically, the health care provider represents that it took reasonable steps (including working with its health IT developer and others as necessary) to verify that its certified EHR technology was connected (that is, implemented and configured) in accordance with applicable standards and law.

In addition to verifying that certified EHR technology was connected and accessible during the relevant reporting period, a health care provider must represent that it took reasonable steps to implement corresponding technologies, standards, policies, practices, and agreements to enable the use of certified EHR technology, including by patients and by other health care providers, and not to limit or restrict appropriate access to or use of information in the health care provider's certified EHR technology. For example, actions to limit or restrict compatibility or interoperability could include implementing or configuring certified EHR technology so as to limit access to certain types of data elements or to the “structure” of the data, or implementing certified EHR technology in ways that limit the types of persons or entities that may be able to access and exchange information, or the types of technologies through which they may do so.

  • Statement 3: A health care provider must attest that it responded in good faith and in a timely manner to requests to retrieve or exchange electronic health information, including from patients, health care providers (as defined by 42 U.S.C. 300jj(3)), and other persons, regardless of the requestor's affiliation or technology vendor.

This third and final statement builds on a health care provider's representations concerning the manner in which its certified EHR technology was implemented by focusing on how the health care provider actually used the technology during the relevant reporting period. By attesting to this statement, a health care provider represents that it acted in good faith to use the certified EHR technology to support the appropriate exchange and use of electronic health information. This includes, for example, taking reasonable steps to respond to requests to access or exchange information, provided that such access or exchange is appropriate, and not unreasonably discriminating on the basis of the requestor's affiliation, technology vendor, or other characteristics, as described in the statement.

We provide further discussion and analysis of the foregoing statements and their application in our responses to the specific comments summarized in the remainder of this section. We believe that these statements, taken together, provide a clear and appropriately detailed description of a health care provider's obligations under section 106(b)(2) of the MACRA, will enable them to demonstrate compliance to the satisfaction of the Secretary, and will promote fair and consistent application of program requirements across all attesting health care providers.

Comment: Several commenters asked us to identify the specific actions and circumstances that would support a finding that a health care provider has knowingly and willfully limited or restricted the compatibility or interoperability of certified EHR technology. Some commenters inquired whether this determination would turn on a health care provider's individual circumstances or other case-by-case considerations, such as a health care provider's practice size, setting, specialty, and level of technology adoption. Commenters also asked whether other circumstances could justify limitations or restrictions on the compatibility or interoperability of certified EHR technology. For example, a commenter asked whether an office-based clinic that periodically turns its computer network off overnight to perform system maintenance would be deemed to have limited the interoperability of its certified EHR technology on the basis that other health care providers might be unable to request and retrieve records during that time. Commenters gave other potential justifications for blocking access to or the exchange of information, such as privacy or security concerns or the need to temporarily block the disclosure of sensitive test results to allow clinicians who order tests an opportunity to discuss the results with their patients prior to sharing the results with other health care providers.

One commenter suggested that we approach this question in the manner described in the Information Blocking Report, which focuses on whether actions that interfere with the exchange or use of electronic health information have any objectively reasonable justification.

Response: The compatibility or interoperability of certified EHR Start Printed Page 77031technology may be limited or restricted in ways that are too numerous and varied to catalog. While section 106(b)(2) of the MACRA specifically mentions actions to disable the functionality of certified EHR technology, other actions that are likely to interfere with the exchange or use of electronic health information could limit or restrict compatibility or interoperability. For example, the Information Blocking Report describes certain categories of business, technical, and organizational practices that are inherently likely to interfere with the exchange or use of electronic health information.[11] These practices include but are not limited to:

  • Contract terms, policies, or other business or organizational practices that restrict individuals' access to their electronic health information or restrict the exchange or use of that information for treatment and other permitted purposes.
  • Charging prices or fees that make exchanging and using electronic health information cost prohibitive.
  • Implementing certified EHR technology in non-standard ways that are likely to substantially increase the costs, complexity, or burden of sharing electronic health information (especially when relevant interoperability standards have been adopted by the Secretary).
  • Implementing certified EHR technology in ways that are likely to “lock in” users or electronic health information (including using certified EHR technology to inappropriately limit or steer referrals).

Such actions would be contrary to section 106(b)(2) only when engaged in “knowingly and willfully.” We believe the purpose of this requirement is to ensure that health care providers are not penalized for actions that are inadvertent or beyond their control.

To illustrate these concepts, we consider several hypothetical scenarios raised by the commenters. First, we consider the situation suggested by one commenter in which a health care provider disables its computer network overnight to perform system maintenance. In this situation, the health care provider knows that the natural and probable consequence of its actions will be to prevent access to information in the certified EHR technology and in this way limit and restrict the interoperability of the technology. However, we recognize that health IT requires maintenance to ensure that capabilities function properly, including in accordance with applicable standards and law. We also appreciate that in many cases it may not be practicable to implement redundant capabilities and systems for all functionality within certified EHR technology, especially for physician practices and other health care providers with comparatively less health IT resources and expertise. Assuming that a health care provider acts in good faith to disable functionality for the purpose of performing system maintenance, it is unlikely that the health care provider would knowingly and willfully limit or restrict the compatibility or interoperability of the certified EHR technology. We note that our assumption that the health care provider acted in good faith presupposes that it did not disable functionality except to the extent and for the duration necessary to ensure the proper maintenance of its certified EHR technology, and that it took reasonable steps to minimize the impact of such maintenance on the ability of patients and other health care providers to appropriately access and exchange information, such as by scheduling maintenance overnight and responding to any requests for access or exchange once the maintenance has been completed and it is otherwise practicable to do so.

Next, we consider the situation in which a health care provider blocks access to information in its certified EHR technology due to concerns related to the security of the information. Depending on the circumstances, certain access restrictions may be reasonable and necessary to protect the security of information maintained in certified EHR technology. In contrast, restrictions that are unnecessary or unreasonably broad could constitute a knowing and willful restriction of the compatibility or interoperability of the certified EHR technology. Because of the complexity of these issues, determining whether a health care provider's actions were reasonable would require additional information about the health care provider's actions and the circumstances in which they took place.

As a final example, we consider whether it would be permissible for a health care provider to restrict access to a patient's sensitive test results until the clinician who ordered the tests, or another designated health care professional, has had an opportunity to review and appropriately communicate the results to the patient. We assume for purposes of this example that, consistent with the HIPAA Privacy Rule, the restriction does not apply to the patient herself or to the patient's request in writing to send this information to any other person the patient designates. With that assumption and under the circumstances we have described, it is likely that the health care provider is knowingly restricting interoperability. We believe that the restriction may be reasonable so long as the health care provider reasonably believes, based on its relationship with the particular patient and its best clinical judgment, that the restriction is necessary to protect the health or wellbeing of the patient. We note that our analysis would be different if the restriction were not based on a health care provider's individualized assessment of the patient's best interests and instead reflected a blanket policy to block access to test results until released by the ordering physician. Similarly, while clinical judgment and the health care provider-patient relationship are entitled to substantial deference, they may not be used as a pretext for limiting or restricting the compatibility or interoperability of certified EHR technology.

The examples provided in this section of the final rule with comment period are intended to be illustrative. We reiterate the need to consider the unique facts and circumstances in each case in order to determine whether a health care provider knowingly and willfully limited or restricted the compatibility or interoperability of certified EHR technology.

Comment: One commenter asked whether the requirement that certified EHR technology complies with federal standards precludes the use of other standards for the exchange of electronic health information.

Response: In general, while certified EHR technology must be connected in accordance with applicable federal standards, this requirement does not preclude the use of other standards or capabilities, provided the use of such standards or capabilities does not limit or restrict the compatibility or interoperability of the certified EHR technology.

Comment: Several commenters requested that we clarify our expectations for timeliness of access to or exchange of information.

Response: As we have explained, whether a health care provider has knowingly and willfully limited or restricted the interoperability of certified EHR technology will depend on the relevant facts and circumstances. While for this reason we decline to Start Printed Page 77032adopt any bright-line rules, we reiterate that a health care provider must attest that it responded in good faith and in a timely manner to requests to retrieve or exchange electronic health information. What will be “timely” will of course vary based on relevant factors such as a health care provider's level of technology adoption and the types of information requested. For requests from patients, we note that while the HIPAA Privacy Rule provides that a covered entity may take up to 30 days to respond to a patient's written request for access to his or her PHI maintained by the covered entity, it is expected that the use of technology will enable the covered entity to fulfill the individual's request in far fewer than 30 days.[12] Where information requested or directed by a patient can be readily provided using the capabilities of certified EHR technology, access should in most cases be immediate and in all cases as expeditious as is practicable under the circumstances.

Comment: Many commenters stated that health care professionals and organizations should not be held responsible for adherence to health IT certification standards or other technical details of health IT implementation that are beyond their expertise or control. According to these commenters, requiring health care providers to attest to these technical implementation details would unfairly place them at financial risk for factors that are beyond the scope of their medical training. Additionally, many commenters took the position that EHR vendors are in the best position to ensure that certified EHR technology is connected in accordance with applicable law and compliant with applicable standards, implementation specifications, and certification criteria.

Response: We reiterate that a health care provider will not be held accountable for factors that it cannot reasonably influence or control, including the actions of EHR vendors. Nor do we expect health care providers themselves to have any special technical expertise or to personally tend to the technical details of their health IT implementations. We do expect, however, that a health care provider will take reasonable steps to verify that the certified EHR technology is connected (that is, implemented and configured) in accordance with applicable standards and law and in a manner that will allow the health care provider to attest to having satisfied the conditions described in the information blocking attestation. In this respect, a health care provider's obligations include communicating these requirements to health IT developers, implementers, and other persons who are responsible for implementing and configuring the health care provider's certified EHR technology. In addition, the health care provider should obtain adequate assurances from these persons to satisfy itself that its certified EHR technology was connected in accordance with applicable standards and law and in a manner that will enable the health care provider to demonstrate that it has not knowingly and willfully take action to limit or restrict the compatibility or interoperability of certified EHR technology.

Comment: Several commenters supported the attestation's emphasis on the bi-directional exchange of structured electronic health information. Multiple commenters suggested that this requirement would expand access to relevant information by members of a patient's care team, allowing them to deliver more effective and comprehensive care, enhance health outcomes, and contribute directly to the goals of quality and affordability. As an example, commenters stated that the bi-directional exchange of information among pharmacists and other clinicians can provide important information for comprehensive medication management.

Other commenters opposed or raised concerns regarding this aspect of our proposal, stating that bi-directional information exchange may not be feasible for many health care providers or may raise a variety of technical and operational challenges and potential privacy or security concerns.

Some commenters requested that CMS clarify the term “bi-directional exchange” and the actions a health care provider would be expected to take to satisfy this aspect of the attestation. One commenter inquired specifically whether bi-directional exchange could include using a health information exchange or other intermediary to connect disparate certified EHR technology so that users could both send and receive information in an interoperable manner. If so, the commenter asked whether a health care provider would be expected to participate in multiple arrangements of this kind (and, if so, how many). Multiple commenters stated that it is not appropriate to allow bi-directional exchange in all circumstances and that privacy, security, safety, and other considerations require health care providers to restrict the types of information that the certified EHR technology will accept and the persons or other sources of that information.

Response: We appreciate that bi-directional exchange of information presents challenges, including the need to validate the authenticity, accuracy, and integrity of data received from outside sources, mitigating potential privacy and security risks, and overcoming technical, workflow, and other related challenges. We also acknowledge that accomplishing bi-directional exchange may be challenging for certain health care providers or for certain types of information or use cases. However, a significant number of health care providers are already exchanging some types of electronic health information in a bi-directional manner. Based upon data collected in 2014, approximately one-fifth of non-federal acute care hospitals electronically sent, received, found (queried), and were able to easily integrate summary of care records into their EHRs.[13] We also note that meaningful EHR users are required to use certified EHR technology that has the capacity to “exchange electronic health information with, and to integrate such information from other sources,” as required by the 2014 and 2015 Edition Base EHR definitions at 45 CFR 170.102 and corresponding certification criteria, such as the transitions of care criteria (45 CFR 170.314(b)(1) and (2) (2014 Edition) and 45 CFR 170.315(b)(2) (2015 Edition)).

We expect these trends to increase as standards and technologies improve and as health care providers, especially those participating in Advanced APMs, seek to obtain more complete and accurate information about their patients with which to coordinate care, manage population health, and engage in other efforts to improve quality and value.

We clarify that bi-directional exchange may include using certified EHR technology with a health information exchange or other intermediary to connect disparate certified EHR technology so that users could both send and receive information in an interoperable manner. Whether a health care provider could participate in Start Printed Page 77033arrangements of this kind, or multiple arrangements, would depend on its particular circumstances, including its technological capabilities and sophistication, its financial resources, its role within the local health care community, and the availability of state or regional health information exchange infrastructure, among other relevant factors. A health care provider is not obligated to participate in every information sharing arrangement or to accommodate every request to connect via a custom interface. On the other hand, a health care provider with substantial resources that refuses to participate in any health information exchange efforts might invite scrutiny if, combined with other relevant facts and circumstances, there were reason to suspect that the health care provider's refusal to participate in certain health information exchange efforts were part of a larger pattern of behavior or a course of conduct to knowingly and willfully limit the compatibility or interoperability of the certified EHR technology.

Comment: Several commenters were concerned about the requirement to respond to requests to retrieve or exchange electronic health information. Commenters stated that health care providers may have difficulty responding to requests from unaffiliated health care providers or from EHR vendors with whom they do not have a business associate agreement.

A few commenters were concerned that health care providers may be penalized for limiting or restricting access to information despite not knowing whether an unaffiliated health care provider or EHR vendor is authorized or permitted to access a patient's PHI. Another commenter noted that some state laws require written patient consent before certain types of health information may be exchanged electronically. Some commenters contested the technical feasibility of exchanging information with unaffiliated health care providers and across disparate certified EHR technologies, explaining that federally-adopted standards such as the Direct standard do not support such robust information sharing. In particular, there is no widely-accepted and standardized method to encode requests in Direct messages, which means that a receiving system will often be unable to understand what information is being requested.

Response: The ability to exchange and use information across multiple systems and health care organizations is integral to the concept of interoperability and, consequently, to a health care provider's demonstration under section 106(b)(2) of the MACRA. Consistent with its attestation, a health care provider must implement technologies, standards, policies, practices, and agreements reasonably calculated to ensure, to the greatest extent practicable and permitted by law, that the certified EHR technology was, at all relevant times implemented in a manner that allowed for timely access by patients to their electronic health information (including the ability to view, download, and transmit this information) and implemented in a manner that allowed for the timely, secure, and trusted bi-directional exchange of structured electronic health information with other health care providers, including unaffiliated providers, and with disparate certified EHR technology and vendors.

We recognize that technical, legal, and other practical constraints may prevent a health care provider from responding to some requests to access, exchange, or use electronic health information in a health care provider's certified EHR technology, even when the requester has permission or the right to access and use the information. We reiterate that in these circumstances a health care provider probably would not have knowingly and willfully limited or restricted the compatibility or interoperability of the certified EHR technology. We expect that these technical and other challenges will become less significant over time and that health care providers will be able to respond to requests from an increasing range of health care providers and health IT systems.

In response to the concerns regarding the disclosure of PHI without a business associate agreement, we remind commenters that the HIPAA Privacy Rule expressly permits covered entities to disclose PHI for treatment, payment, and operations. We refer commenters to numerous guidance documents and fact sheets issued by the HHS Office for Civil Rights and ONC on this subject.[14] We also caution that mischaracterizing or misapplying the HIPAA Privacy Rule or other legal requirements in ways that are likely to limit or restrict the compatibility or interoperability of certified EHR technology might be inconsistent with the requirements of section 106(b)(2) of the MACRA and a health care provider's information blocking attestation. As an example, a health system that maintains a policy or practice of refusing to share PHI with unaffiliated health care providers on the basis of generalized and unarticulated “HIPAA compliance concerns” could be acting contrary to section 106(b)(6) and the information blocking attestation. The same would be true were a health care provider to inform a patient that it is unable to share information electronically with the patient's other health care professionals “due to HIPAA.”

Comment: A small number of commenters, primarily health IT developers, recommended that any requirements to exchange information be limited to the use of certified health IT capabilities required by the 2015 Edition health IT certification criteria or 2014 Edition EHR certification criteria (45 CFR 170.102), as applicable. In contrast, a commenter stated that a significant amount of health information is exchanged through means other than the standards and capabilities supported by ONC's certification criteria for health IT. The commenter cited as an example the widespread use of health information exchanges (HIEs) and network-to-network exchanges, which may or may not incorporate the use of certified health IT capabilities. The commenter insisted that these approaches should not be regarded as information blocking and should be treated as evidence that a health care provider is supporting and participating in efforts to exchange electronic health information. Another commenter stated that the requirement to respond to requests to retrieve or exchange electronic health information should be satisfied by connecting certified EHR technology to a network that can be accessed by other health care providers.

Response: We decline to limit the attestation to the use of certified health IT capabilities or to give special weight to any particular form or method of exchange. As observed by the commenters, certified EHR technology may be implemented and used in many different ways that support the exchange and use of electronic health information. A health care provider's use of these forms and methods of exchange may be relevant to determining whether it acted in good faith to implement and use its certified EHR technology in a manner that supported and did not limit or restrict the compatibility or interoperability of the technology. As an example, certified Start Printed Page 77034EHR technology may come bundled with a health information service provider (HISP) that limits the ability to send and receive Direct messages to certain health care providers, such as those whose EHR vendor participates in a particular trust network. To overcome this or other technical limitations, a health care provider may participate in a variety of other health information sharing arrangements, whether to expand the reach of its Direct messaging capabilities or to enable other methods of exchanging and using electronic health information in its certified EHR technology. We believe that these and similar actions may be relevant to and should not be excluded from the consideration of the health care provider's overall actions to enable the interoperability of its certified EHR technology and to respond in good faith to requests to access or exchange electronic health information.

Comment: Some commenters recommended that we revise the language of the attestation in whole or in part. Most of these commenters suggested removing certain language or statements, or combining them, to make the requirements of the attestation easier to understand or comply with. One commenter suggested that we abandon the proposed language and adopt the commenter's alternative language, which would require health care providers to attest that they established a workflow for responding to requests to retrieve or exchange electronic health information and did not knowingly or willfully limit or restrict the compatibility or interoperability of certified EHR technology during the development or implementation of the workflow, or in any subsequent actions related to the workflow.

Response: We appreciate commenters' suggestions, but for the reasons we have explained, we do not believe it is appropriate to remove or to further simplify the language of the attestation. Although we do not adopt the alternative language suggested by one commenter, we observe that the actions the commenter describes are consistent with our expectation that health care providers implement certified EHR technology in a manner reasonably calculated to facilitate interoperability, to the greatest extent practicable, and respond in good faith to requests to retrieve or exchange information.

Comment: Several commenters claimed that the proposed attestation is not necessary because most health care providers are not knowingly or willfully engaging in actions to limit or restrict the interoperability or compatibility of certified EHR technology, or to otherwise interfere with the exchange or use of electronic health information. Some of these commenters, while acknowledging that some health care providers may be engaging in actions that could limit or restrict the interoperability or compatibility of certified EHR technology, maintained that such actions are justified or are beyond a health care provider's control. Some commenters supported an attestation for hospitals or health systems but not for physicians, on the basis that the majority of individual EHR users are not engaging in information blocking.

Response: The belief that health care providers do not engage in information blocking is contradicted by an increasing body of evidence and research, by the experience of CMS and ONC, and by many of the comments on this proposal.[15] It is also inconsistent with section 106(b)(2) of the MACRA, which is entitled “Preventing Blocking The Sharing Of Information” and expressly requires health care providers to demonstrate that they did not knowingly and willingly take action to limit or restrict the interoperability of certified EHR technology.

We need not contemplate whether health systems or any other class of health care provider is more predisposed to engage in information blocking, because the attestation we are finalizing implements section 106(b)(2) of the MACRA, which extends to all MIPS eligible clinicians, eligible clinicians part of an APM Entity, EPs, eligible hospitals, and CAHs.

Comment: Some commenters suggested that, in lieu of an attestation, that CMS allow health care providers to demonstrate compliance with section 106(b)(2) by reporting on objectives and measures under the Medicare and Medicaid EHR Incentive Programs or the advancing care information performance category of MIPS. Commenters noted that health care providers participating in these programs must utilize CEHRT, including application programing interfaces (APIs) that provide access to patient data, and that participation in these programs should itself provide an adequate assurance that health care providers are not knowingly and willfully limiting or restricting the compatibility or interoperability of certified EHR technology.

Response: We do not believe that a health care provider's reporting of objectives and measures can provide the demonstration required by section 106(b)(2) of the MACRA. The compatibility or interoperability of certified EHR technology may be limited or restricted in numerous and varied ways that are difficult to anticipate and that may not be reflected in objectives and measures under the EHR Incentive Programs and MIPS, which address a broad range of aspects related to the use of certified health IT. It is therefore entirely possible that a health care provider could implement and use certified EHR technology and meet relevant objectives and measures while still engaging in many actions that limit or restrict compatibility or interoperability. While in theory we could specify additional objectives and measures specifically related to the prevention of health information blocking, at this time we believe a less burdensome and more effective way to obtain adequate assurances that health care providers have not engaged in these prohibited practices is through the information blocking attestation we proposed and are finalizing.

Comment: Many commenters stated that EHR vendors, not health care providers, are the primary cause of existing barriers to interoperability and information exchange. Many of these commenters stated that EHR vendors are engaging in information blocking, with some commenters alleging that EHR vendors are routinely engaging in these practices. Commenters alleged that EHR vendors are unwilling to share data in certain circumstances or charge fees that make such sharing cost-prohibitive for most physicians, which poses a significant barrier to interoperability and the efficient exchange of electronic health information.

For these reasons, many commenters suggested that CMS or ONC to require EHR vendors and other health IT developers to attest to an information blocking attestation or to impose other requirements and penalties on developers to deter them from limiting or restricting the interoperability of certified EHR technology and to encourage them to proactively facilitate the sharing of electronic health information. For example, commenters supported the decertification of EHR vendors that charge excessive fees or engage in other practices that may constitute information blocking.

Response: We agree that eligible clinicians, EPs, eligible hospitals, and CAHs are by no means the only persons or entities that may engage in information blocking. However, requirements for EHR vendors or other health IT developers are beyond the Start Printed Page 77035scope of section 106(b)(2) of the MACRA and this rulemaking.

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

Comment: Several commenters requested clarification regarding the documentation that would be required to demonstrate compliance with the terms of the attestation so that health care providers could both better understand and prepare for an audit of this requirement. Among other topics, commenters requested guidance on expected documentation requirements related to particular technologies or capabilities as well as a health care provider's responsiveness to requests to exchange information.

Response: We acknowledge commenters' concerns about required documentation in cases of an audit. To alleviate those concerns, we clarify that we will provide guidance to auditors relating to the final policy and the attestation process. This instruction should include requiring auditors to work closely with health care providers on the supporting documentation needed applicable to the health care provider's individual case. We further stress that audit determinations are made on a case by case basis, which allows us to give individual consideration to each health care provider. We believe that such case-by-case review will allow us to adequately account for the varied circumstances that may be relevant to assessing compliance.

Comment: Some commenters stated that it would be inappropriate for ONC or an ONC-ACB to perform surveillance of a health care provider's certified EHR technology to determine whether the health care provider is limiting or restricting interoperability.

Response: The scope of ONC-ACB surveillance or, if finalized, ONC's review of a health care provider's certified EHR technology is limited to determining whether the technology continues to perform in accordance with the requirements of the ONC Health IT Certification Program. Because this oversight focuses on the performance of the technology itself, not on the actions of health care providers or users of the technology, we do not anticipate that information obtained in the course of such ONC-ACB surveillance or ONC review would be used to audit a health care provider's compliance with its information blocking attestation. As a caveat, we acknowledge that if ONC became aware that a health care provider had submitted a false attestation or engaged in other actions in violation of federal law or requirements, ONC could share that information with relevant federal entities.

Comment: Some commenters asked how often attestations would be required (for example, once per year). Commenters also stated that the information blocking attestation should apply prospectively, possibly beginning with reporting periods commencing in 2017, to provide reasonable notice to affected parties.

Response: MIPS eligible clinicians, eligible clinicians part of an APM Entity, EPs, eligible hospitals, and CAHs must submit an information blocking attestation covering each reporting period during which they seek to demonstrate that they were a meaningful EHR user or for which they seek to report on the advancing care information performance category. We agree that the attestation requirements should apply only to actions occurring after the effective date of this final rule with comment period. For this reason and to promote alignment with other reporting requirements, we are finalizing the information blocking attestation for attestations covering EHR reporting periods and MIPS performance periods beginning on or after January 1, 2017.

After review and consideration of public comment, we are finalizing the attestation requirement as proposed. We are finalizing this requirement for EPs, eligible hospitals, and CAHs under the Medicare and Medicaid EHR Incentive Programs and for eligible clinicians under the advancing care information performance category in MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM scoring standard. We are finalizing this requirement for attestations covering EHR reporting periods and MIPS performance periods beginning on or after January 1, 2017.

We have revised and are finalizing the proposed regulation text accordingly. Specifically, we are finalizing the revisions to the definition of a meaningful EHR user at § 495.4 and we are adding the same to the definition of a meaningful EHR user for MIPS at § 414.1305. We are finalizing the attestation requirements at § 495.40(a)(2)(i)(I) and (b)(2)(i)(I) to require such an attestation from EPs, eligible hospitals, and CAHs as part of their demonstration of meaningful EHR use under the Medicare and Medicaid EHR Incentive Programs. We are also finalizing § 414.1375(b)(3) to require this attestation from all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM scoring standard as discussed in section II.E.5.h. of this final rule with comment period.

D. Definitions

At § 414.1305, in subpart O, we proposed definitions for the following terms:

  • Additional performance threshold.
  • Advanced Alternative Payment Model (Advanced APM).
  • Advanced APM Entity.
  • Affiliated practitioner.
  • Affiliated practitioner list.
  • Alternative Payment Model (APM).
  • APM Entity.
  • APM Entity group.
  • APM Incentive Payment.
  • Attestation.
  • Attributed beneficiary.
  • Attribution-eligible beneficiary.
  • Certified Electronic Health Record Technology (CEHRT).Start Printed Page 77036
  • CMS-approved survey vendor.
  • CMS Web Interface.
  • Covered professional services.
  • Eligible clinician.
  • Episode payment model.
  • Estimated aggregate payment amounts.
  • Final score.
  • Group.
  • Health Professional Shortage Areas (HPSA).
  • High priority measure.
  • Hospital-based MIPS eligible clinician.
  • Improvement activities.
  • Incentive payment base period.
  • Low-volume threshold.
  • Meaningful EHR user for MIPS.
  • Measure benchmark.
  • Medicaid APM.
  • Medical Home Model.
  • Medicaid Medical Home Model.
  • Merit-based Incentive Payment System (MIPS).
  • MIPS APM.
  • MIPS eligible clinician.
  • MIPS payment year.
  • New Medicare-Enrolled MIPS eligible clinician.
  • Non-patient facing MIPS eligible clinician.
  • Other Payer Advanced APM.
  • Other payer arrangement.
  • Partial Qualifying APM Participant (Partial QP).
  • Partial QP patient count threshold.
  • Partial QP payment amount threshold.
  • Participation List.
  • Performance category score.
  • Performance standards.
  • Performance threshold.
  • Qualified Clinical Data Registry (QCDR).
  • Qualified registry.
  • QP patient count threshold.
  • QP payment amount threshold.
  • QP Performance Period.
  • Qualifying APM Participant (QP).
  • Rural areas.
  • Small practices.
  • Threshold Score.
  • Topped out non-process measure.
  • Topped out process measure.

Some of these terms are new in conjunction with MIPS and APMs, while others are used in existing CMS programs. For the new terms and definitions, we note that some of them have been developed alongside policies of this regulation while others are defined by statute. Specifically, the following terms and definitions were established by the MACRA: APM, Eligible Alternative Payment Entity (which we refer to as an Advanced APM Entity), Composite Performance Score (which we refer to as final score), Eligible professional or EP (which we refer to as an eligible clinician), MIPS Eligible professional or MIPS EP (which we refer to as a MIPS eligible clinician), MIPS adjustment factor (which we refer to as a MIPS payment adjustment factor), additional positive MIPS payment adjustment factor (which we refer to as additional MIPS payment adjustment factor), Qualifying APM Participant, and Partial Qualifying APM Participant.

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

E. MIPS Program Details

1. MIPS Eligible Clinicians

We believe a successful MIPS program fully equips clinicians identified as MIPS eligible clinicians with the tools and incentives to focus on improving health care quality, efficiency, and patient safety for all their patients. Under MIPS, MIPS eligible clinicians are incentivized to engage in proven improvement measures and activities that impact patient health and safety and are relevant for their patient population. One of our strategic goals in developing the MIPS program is to advance a program that is meaningful, understandable, and flexible for participating MIPS eligible clinicians. One way we believe this will be accomplished is by minimizing MIPS eligible clinicians' burden. We have made an effort to focus on policies that remove as much administrative burden as possible from MIPS eligible clinicians and their practices while still providing meaningful incentives for high-quality, efficient care. In addition, we hope to balance practice diversity with flexibility to address varied MIPS eligible clinicians' practices. Examples of this flexibility include special consideration for non-patient facing MIPS eligible clinicians, an exclusion from MIPS for eligible clinicians who do not exceed the low-volume threshold, and other proposals discussed below.

a. Definition of a MIPS Eligible Clinician

Section 1848(q)(1)(C)(i) of the Act, as added by section 101(c)(1) of the MACRA, outlines the general definition of a MIPS eligible clinician for the MIPS program. Specifically, for the first and second year for which MIPS applies to payments (and the performance period for such years) a MIPS eligible clinician is defined as a physician (as defined in section 1861(r) of the Act), a physician assistant, nurse practitioner, clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act), a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), and a group that includes such professionals. The statute also provides flexibility to specify additional eligible clinicians (as defined in section 1848(k)(3)(B) of the Act) as MIPS eligible clinicians in the third and subsequent years of MIPS. As discussed in the proposed rule (81 FR 28177 through 28178), section 1848(q)(1)(C)(ii) and (v) of the Act specifies several exclusions from the definition of a MIPS eligible clinician, which includes clinicians who are determined to be new Medicare-enrolled eligible clinicians, QPs and Partial QPs, or do not exceeded the low-volume threshold pertaining to the dollar value of billed Medicare Part B allowed charges or Part B-enrolled beneficiary count. In addition, section 1848(q)(1)(A) of the Act requires the Secretary to permit any eligible clinician (as defined in section 1848(k)(3)(B) of the Act) who is not a MIPS eligible clinician the option to volunteer to report on applicable measures and activities under MIPS. Section 1848(q)(1)(C)(vi) of the Act clarifies that a MIPS payment adjustment factor (or additional MIPS payment adjustment factor) will not be applied to an individual who is not a MIPS eligible clinician for a year, even if such individual voluntarily reports measures under MIPS. For purposes of this section of the final rule with comment period, we use the term “MIPS payment adjustment” to refer to the MIPS payment adjustment factor (or additional MIPS payment adjustment factor) as specified in section 1848(q)(1)(C)(vi) of the Act.

To implement the MIPS program we must first establish and define a MIPS eligible clinician in accordance with the statutory definition. We proposed to define a MIPS eligible clinician at § 414.1305 as a physician (as defined in section 1861(r) of the Act), a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act), a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), and a group that includes such professionals. In addition, we proposed that QPs and Partial QPs who do not report data under MIPS, low-volume threshold eligible clinicians, and new Medicare-enrolled eligible clinicians as defined at § 414.1305 would be excluded from this definition per the statutory exclusions defined in section 1848(q)(1)(C)(ii) and (v) of the Act. We intend to consider using our authority under section 1848(q)(1)(C)(i)(II) of the Act to expand the definition of a MIPS eligible Start Printed Page 77037clinician to include additional eligible clinicians (as defined in section 1848(k)(3)(B) of the Act) through rulemaking in future years.

Additionally, in accordance with section 1848(q)(1)(A) and (q)(1)(C)(vi) of the Act, we proposed to allow eligible clinicians who are not MIPS eligible clinicians, as defined at proposed § 414.1305, the option to voluntarily report measures and activities for MIPS. We proposed at § 414.1310(d) that those eligible clinicians who are not MIPS eligible clinicians, but who voluntarily report on applicable measures and activities specified under MIPS, would not receive an adjustment under MIPS; however, they would have the opportunity to gain experience in the MIPS program. We were particularly interested in public comments regarding the feasibility and advisability of voluntary reporting in the MIPS program for entities such as RHCs and/or FQHCs, including comments regarding the specific technical issues associated with reporting that are unique to these health care providers. We anticipate some eligible clinicians that will not be MIPS eligible clinicians during the first 2 years of MIPS, such as physical and occupational therapists, clinical social workers, and others that have been reporting quality measures under the PQRS for a number of years, will want to have the ability to continue to report and gain experience under MIPS. We requested comments on these proposals.

The following is a summary of the comments we received regarding our proposed definition of the term MIPS eligible clinician and our proposal to allow eligible clinicians who are not MIPS eligible clinicians the option to voluntarily report measures and activities for MIPS.

Comment: Commenters supported the option for RHCs and FQHCs to voluntary report, but noted that RHCs and FQHCs may not have experience using EHR technology or the resources to invest in CEHRT and requested that CMS adjust for the social determinants of health status.

Response: We appreciate the feedback on the role of socioeconomic status in quality measurement. We continue to evaluate the potential impact of social risk factors on measure performance. One of our core objectives is to improve beneficiary outcomes, and we want to ensure that complex patients as well as those with social risk factors receive excellent care.

Comment: Several commenters expressed support for the proposed definition of a MIPS eligible clinician and the proposal to allow eligible clinicians who are not MIPS eligible to voluntarily report, which encourages interdisciplinary and team-based services necessary to address the full spectrum of patient and family needs and quality of life concerns throughout the care continuum and across health system and community-based care settings. One commenter expressed appreciation for CMS using practitioner-neutral language and including nurse practitioners.

Response: We appreciate the support from commenters.

Comment: In regard to the definition of a MIPS eligible clinician, one commenter recommended that certified registered nurse anesthetists be removed from the list of MIPS eligible clinicians because there are not applicable measures for their job duties and they do not treat diseases. Another commenter requested that CMS align the definition of an eligible clinician in both the Medicare and Medicaid programs because nurse practitioners do not qualify for the Medicare EHR Incentive Program for Eligible Professionals, but do qualify for the Medicaid EHR Incentive Program for Eligible Professionals. One commenter expressed concern with the inclusion of nurse practitioners and physician assistants in the definition of a MIPS eligible clinician due to such providers needing to purchase and implement an EHR system in a short timeframe and requested that CMS postpone the inclusion of nurse practitioners and physician assistants.

Response: We appreciate the recommendations from the commenters and note that section 1848(q)(1)(C)(i) of the Act defines a MIPS eligible clinician, for the first and second MIPS payment years, as a physician (as defined in section 1861(r) of the Act), a physician assistant, nurse practitioner, clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act), a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), and a group that includes such professionals. We do not have discretion under the statute to amend the definition of a MIPS eligible clinician by excluding clinician types that the statute expressly includes, such as certified registered nurse anesthetists, nurse practitioners, and physician assistants. We note, however, that several policies may alleviate the concerns of commenters regarding the availability of applicable measures and activities, and health IT implementation costs. For example, as discussed in section II.E.3.c. of this final rule with comment period, we are finalizing a higher low-volume threshold to ensure that MIPS eligible clinicians who do not exceed $30,000 of billed Medicare Part B allowed charges or 100 Part B-enrolled Medicare beneficiaries are excluded from MIPS. Also, we note that while non-patient facing MIPS eligible clinicians are not exempt from participating in MIPS or a performance category entirely, as discussed in section II.E.1.b. of this final rule with comment period, we are establishing a process that applies, to the extent feasible and appropriate, alternative measures or activities for non-patient facing MIPS eligible clinicians that fulfill the goals of the applicable performance category. In addition, as discussed in section II.E.6.b.(2) of this final rule with comment period, we may re-weight performance categories if there are not sufficient measures applicable and available to each MIPS eligible clinician to ensure that MIPS eligible clinicians, including those who are non-patient facing, who do not have sufficient alternative measures and activities that are applicable and available in a performance category are scored appropriately.

In addition, we recognize that under MIPS, there will be more eligible clinicians subject to the requirements of EHR reporting than were previously eligible under the Medicare and/or Medicaid EHR Incentive Program, including hospital-based MIPS eligible clinicians, nurse practitioners, physician assistants, clinical nurse specialists, and certified registered nurse anesthetists. Since many of these non-physician clinicians are not eligible to participate in the Medicare and/or Medicaid EHR Incentive Program, we have little evidence as to whether there are sufficient measures applicable and available to these types of MIPS eligible clinicians under our proposals for the advancing care information performance category. As a result, we have provided additional flexibilities to mitigate negative adjustments for the first performance year (CY 2017) in order to allow hospital-based MIPS eligible clinicians, nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists, and other MIPS eligible clinicians to familiarize themselves with the MIPS program. Section II.E.5.g.(8) of this final rule with comment period describes our final policies regarding the re-weighting of the advancing care information performance category within the final score, in which we would assign a weight of zero when there are not sufficient measures applicable and available.

Comment: One commenter requested for suppliers of portable x-ray and Start Printed Page 77038independent diagnostic testing facility services to be excluded from the definition of a MIPS eligible clinician and recommended that CMS create an alternate pathway allowing for adequate payment updates to reflect the rising cost of care.

Response: We note that the MIPS payment adjustment applies only to the amount otherwise paid under Part B with respect to items and services furnished by a MIPS eligible clinician during a year. As discussed in section II.E.7. of this final rule with comment period, we will apply the MIPS adjustment at the TIN/NPI level. In regard to suppliers of portable x-ray and independent diagnostic testing facility services, we note that such suppliers are not themselves included in the definition of a MIPS eligible clinician. However, there may be circumstances in which a MIPS eligible clinician would furnish the professional component of a Part B covered service that is billed by such a supplier. For example, a radiologist who is a MIPS eligible clinician could furnish the interpretation and report (professional component) for an x-ray service, and the portable x-ray supplier could bill for the global x-ray service (combined technical and professional component) or bill separately for the professional component of the x-ray service. In that case, the professional component (billed either on its own or as part of the global service) could be considered a service for which payment is made under Part B and furnished by a MIPS eligible clinician. Those services could be subject to MIPS adjustment based on the MIPS eligible clinician's performance during the applicable performance period. Because, however, those services are billed by suppliers that are not MIPS eligible clinicians, it is not operationally feasible for us at this time to associate those billed allowed charges with a MIPS eligible clinician at an NPI level in order to include them for purposes of applying any MIPS payment adjustment.

Comment: One commenter indicated that the status of pathologists working in independent laboratories is unclear with regard to the definition of a MIPS eligible clinician and requested clarification as to whether or not they would be included given that they were considered EPs under PQRS.

Response: We note that pathologists, including pathologists practicing in independent laboratories, are considered MIPS eligible clinicians and thus, required to participate in MIPS and subject to the MIPS payment adjustment. The MIPS payment adjustment applies only to the amount otherwise paid under Part B with respect to items and services furnished by a MIPS eligible clinician during a year, in which we will apply the MIPS adjustment at the TIN/NPI level (see section II.E.7. of this final rule with comment period). For items and services furnished by a pathologist practicing in an independent laboratory that are billed by the laboratory, such items and services may be subject to MIPS adjustment based on the MIPS eligible clinician's performance during the applicable performance period. For those billed Medicare Part B allowed charges we are able to associate with a MIPS eligible clinician at an NPI level, such items and services furnished by such pathologist would be included for purposes of applying any MIPS payment adjustment.

Comment: A few commenters encouraged CMS to expand the list of MIPS eligible clinicians further to promote integrated care. One commenter suggested that we include certified nurse midwives as MIPS eligible clinicians. Another commenter encouraged CMS to ensure that specialists can successfully participate in the MIPS. One commenter indicated that MIPS accommodates the masses of physicians, but falls short in including consulted clinicians. A few commenters requested that we expand the definition of a MIPS eligible clinician to include therapists, dieticians, social workers, and other Medicare Part B suppliers as soon as possible in order for such clinicians to earn positive MIPS payment adjustments. One commenter recommended that the definition of MIPS eligible clinician be expanded to include all Medicare supplier types, including ambulatory services.

Response: We appreciate the suggestions from the commenters and will take them into account as we consider expanding the definition of a MIPS eligible clinician for year 3 in future rulemaking. We interpret the comment regarding consulted clinicians to refer to locum tenens and clinicians contracted by a practice. We note that contracted clinicians who meet the definition of a MIPS eligible clinician are required to participate in MIPS. In regard to locum tenens clinicians, they bill for the items and services they furnish using the NPI of the clinician for whom they are substituting and, as such, do not bill Medicare in their own right for the items and services they furnish. As such, locum tenens clinicians are not MIPS eligible clinicians when they practice in that capacity.

Comment: One commenter indicated that it is feasible to include physical therapists in the expanded definition of a MIPS eligible clinician given that physical therapists have been included in PQRS since 2007. The commenter noted that there will be a negative impact on the quality reporting rates of physical therapists if they are excluded from MIPS in 2017 and 2018. Another commenter recommended that CMS define provisions for physical therapists, occupational therapists, and speech language pathologists as soon as possible in order to provide sufficient time for building new systems for operation in year 3 of MIPS. A few commenters requested clarification on how MIPS will apply to physical therapists, occupational therapists, and speech language pathologists working with Medicare beneficiaries. One commenter suggested that therapists participating in MIPS should be scored using the same scoring weights for the quality and cost performance categories that apply to MIPS eligible clinicians in the first 2 years. The commenter noted that the same transition scoring would be fair and could mitigate severe penalties for clinicians new to MIPS.

Response: We appreciate the concerns and recommendations from the commenters. In regard to expanding the definition of a MIPS eligible clinician for year 3, we will consider the suggestions from the commenters. We anticipate that some eligible clinicians who will not be included in the definition of a MIPS eligible clinician during the first 2 years of MIPS, such as physical and occupational therapists, clinical social workers, and others that have been reporting quality measures under the PQRS for a number of years, will want to have the ability to continue to report and gain experience under MIPS. We note that eligible clinicians who are not included in the definition of a MIPS eligible clinician during the first 2 years of MIPS (or any subsequent year) may voluntarily report on measures and activities under MIPS, but will not be subject to the MIPS payment adjustment. We do intend however to provide informative performance feedback to clinicians who voluntarily report to MIPS, which would include the same performance category and final score rules that apply to all MIPS eligible clinicians. We believe this informational performance feedback will help prepare those clinicians who voluntarily report to MIPS.

Comment: Some commenters requested that CMS allow facility-based clinicians who provide outpatient services, such as physical therapists, occupational therapists, and speech language pathologists, to participate in MIPS and earn MIPS payment Start Printed Page 77039adjustments by the third year of the program. One commenter expressed concern that without inclusion in the Quality Payment Program, these facility-based clinicians would be disadvantaged. Another commenter expressed concern that the criteria for including non-physician clinicians later in MIPS are not clear and recommended that clarity be provided, including performance categories that are specific to each specialty and type of practice.

Response: We appreciate the concerns and recommendations from the commenters, and will take them into account as we consider expanding the definition of a MIPS eligible clinician for year 3 in future rulemaking.

Comment: One commenter did not support the expanding of the definition of a MIPS eligible clinician in year 3. The commenter noted that none of their physical therapists operate on the use of CEHRT and switching in year 3 would require significant capital and personnel. The commenter recommended postponing any expansion until year 4 or 5.

Response: We appreciate the commenter expressing concerns and recognize that eligible clinicians and MIPS eligible clinicians will have a spectrum of experiences with using EHR technology. As we consider expanding the definition of a MIPS eligible clinician to include additional eligible clinicians in year 3, we will consider how such eligible clinicians would be scored for each performance category in future rulemaking.

Comment: One commenter recommended that CMS convene a technical expert panel of eligible clinicians who will not be included in the definition of a MIPS eligible clinician during the first 2 years of MIPS to help adapt the Quality Payment Program to their needs.

Response: We thank the commenter for the suggestion and will consider the recommendation as we consider expanding the definition of a MIPS eligible clinician to include additional eligible clinicians for year 3 in future rulemaking and prepare for the operationalization of the expanded definition. We are committed to continuously engage stakeholders as we implement MIPS, and establish and operationalize future policies.

Comment: One commenter expressed concern about the difficulties hospital-based clinicians have had reporting under PQRS and recommended offering hospital-based clinicians more flexibility in adopting MIPS.

Response: As previously noted, we recognize that there may not be sufficient measures applicable and available for certain performance categories for hospital-based MIPS eligible clinicians participating in MIPS. In section II.E.5.g.(8)(a)(i) of this final rule with comment period, we describe the re-weighting of the advancing care information performance category when there are not sufficient measures applicable and available for hospital-based MIPS eligible clinicians.

Comment: A few commenters expressed concerns that our MIPS proposals focused on clinicians in large groups or who are hospital-based and did not include non-physician clinicians. One commenter requested that non-physician clinicians be recognized for their critical role in the health delivery system and providing high quality, low cost health care to the Medicare population.

Response: We disagree with the commenters and note that the definition of a MIPS eligible clinician includes non-physician clinicians such physician assistants, nurse practitioners, clinical nurse specialists, and certified registered nurse anesthetists. As previously noted, in future rulemaking, we will consider expanding the definition of a MIPS eligible clinician to include additional eligible clinicians starting in year 3.

Comment: A few commenters requested clarification regarding whether or not Doctors of Chiropractic would be able to participate in MIPS. Another commenter appreciated that Doctors of Chiropractic are included as MIPS eligible clinicians, but believed that chiropractors would be put at a severe disadvantage in participating in MIPS or APMs due to CMS' restrictions on chiropractic coverage. The commenter encouraged CMS to expand the billing codes for Doctors of Chiropractic to cover the full scope of licensure.

Response: We note that chiropractors are included in the definition of “physician” under section 1861(r) of the Act, and therefore, are MIPS eligible clinicians. In regard to the comment pertaining to the expansion of billing codes for chiropractors, we note that such comment is out-of-scope given that we did not propose any billing code policies in the proposed rule.

Comment: One commenter requested clarification on whether or not participation in MIPS is mandatory.

Response: We note that clinicians who are included in the definition of a MIPS eligible clinicians as defined in section II.E.1.a. of this final rule with comment period are required to participate in MIPS unless they are excluded from the definition of a MIPS eligible clinician based on one of the three exclusions described in sections II.E.3.a., II.E.3.b., and II.E.3.c. of this final rule with comment period.

Comment: One commenter requested clarification on how CMS will treat hospitalist services under MIPS, specifically, what measures will they report, whether the hospital's PFS payment amount for the hospitalists' services will be subject to the MIPS payment adjustment, and how hospitalists should report data since they do not have an office practice or an EHR to participate.

Response: We note that hospitalists are required to participate in MIPS unless otherwise excluded. As discussed in section II.E.6.b.(2) of this final rule with comment period, we may re-weight performance categories if there are not sufficient measures applicable and available to each MIPS eligible clinician to ensure that MIPS eligible clinicians, including hospitalists, who do not have sufficient alternative measures and activities that are applicable and available in a performance category are scored appropriately. For hospitalists who meet the definition of a hospital-based MIPS eligible clinician, section II.E.5.g.(8)(a)(i) of this final rule with comment period describes the re-weighting of the advancing care information performance category within the final score, in which we would assign a weight of zero when there are not sufficient measures applicable and available for hospital-based MIPS eligible clinicians. In section II.E.5.b.(5) of the proposed rule (81 FR 28192), we sought comment on the application of additional system measures, which would directly impact hospitalists, and intend to address such policies in future rulemaking. Also, we note that the MIPS payment adjustment would be applied to the Medicare Part B payments for items and services furnished by a hospital-based MIPS eligible clinician.

Comment: Some commenters expressed concern regarding the exclusion of pharmacists under MIPS and APMs, and indicated that the payment models would prevent program goals from being met unless all practitioners, including pharmacists, are effectively integrated into team-based care. A few commenters noted that pharmacists are medication-use experts in the health care system, and directly contribute toward many of the quality measures under both MIPS and Advanced APMs. Because pharmacists are neither MIPS eligible clinicians nor required practitioners under APMs, pharmacist expertise and contributions may be underutilized and/or unavailable to certain patients. A few Start Printed Page 77040commenters recommended that the definition of a MIPS eligible clinician include pharmacists given that they are a critical part of a patient care team, in which they can provide a broad array of services to patients and have a role in optimizing patient health outcomes as the number and complexity of medications continues to rise. One commenter recommended that the Quality Payment Program include metrics and payment methodologies that recognize services provided by pharmacists and align with other CMS and CDC programs.

Response: We appreciate the suggestions from the commenters. We note that we do not have discretion under the statute to include clinicians who do not meet the definition of a MIPS eligible clinician. Thus, pharmacists would not be able to participate in MIPS.

Comment: One commenter requested that CMS clarify whether or not MIPS requirements would apply to clinicians who are not Medicare-enrolled eligible clinicians. Another commenter expressed concern that the proposed rule did not address how MIPS payment adjustments would be applied for clinicians who are not Medicare-enrolled eligible clinicians.

Response: We note that clinicians who are included in the definition of a MIPS eligible clinician and not otherwise excluded are required to report under MIPS. However, a clinician who is not included in the definition of a MIPS eligible clinician can voluntarily report under MIPS and would not be subject to the MIPS payment adjustment. Also, we note that eligible clinicians who are not Medicare-enrolled eligible clinicians are not required to participate in MIPS, and would not be subject to the MIPS payment adjustment given that the MIPS payment adjustment is applied to Medicare Part B payments for items and services furnished by a MIPS eligible clinician.

Comment: One commenter requested information on how locum tenens clinicians will be assessed under MIPS.

Response: As previously noted, locum tenens clinicians bill for the items and services they furnish using the NPI of the clinician for whom they are substituting and, as such, do not bill Medicare in their own right for the items and services they furnish. As such, locum tenens clinicians are not MIPS eligible clinicians when they practice in that capacity.

Comment: One commenter noted that facility-based clinicians in California face unique challenges under state law and recommended that rather than automatically using an eligible clinician's facility's performance as a proxy for the quality and cost performance categories as proposed, CMS should develop a voluntary option to allow eligible clinicians who meet criteria to be considered a facility-based clinician.

Response: We appreciate the suggestions from the commenter and will consider them as we develop policies for applying a facility's performance to a MIPS eligible clinician or group.

Comment: One commenter suggested that the types of eligible clinicians who are not included in the definition of a MIPS eligible clinician in 2017 and who have been submitting PQRS measures for years, should be allowed to voluntarily participate in 2017 and earn MIPS payment adjustments if they complete a successful attestation.

Response: We thank the commenter for their suggestion and note that clinicians not included in the definition of a MIPS eligible clinicians have the option to voluntarily report on applicable measures and activities under MIPS. However, the statute does not permit such clinicians to be subject to the MIPS payment adjustment. Should we expand the definition of a MIPS eligible clinician in future rulemaking, such clinicians may be able to earn MIPS payment adjustments beginning as early as the 2021 payment year.

Comment: A few commenters recommended that certified anesthesiologist assistants be included in the definition of a MIPS eligible clinician. One commenter stated that such inclusion would provide the clarification that certified anesthesiologist assistants are health care providers, increase the amount of quality reporting under MIPS, and ensure certified anesthesiologist assistant participation in APMs. The commenter noted that if certified anesthesiologist assistants are not included in the definition of a MIPS eligible clinician, patient access to care would be restricted. Another commenter requested clarification regarding whether or not anesthesiologist assistants would be excluded from MIPS reporting in 2017.

Response: We appreciate the suggestion from the commenters and note that section 1861(bb)(2) of the Act specifies that the term “certified registered nurse anesthetist” includes an anesthesiologist assistant. Thus, anesthesiologist assistants are considered eligible for MIPS beginning with the CY 2017 performance period.

Comment: One commenter requested that audiologists remain active stakeholders in the MIPS implementation process, although they may not be included in the program until year 3.

Response: We appreciate the recommendation from the commenter and note that we are committed to actively engaging with all stakeholders during the development and implementation of MIPS.

Comment: One commenter suggested that CPC+ clinicians should be waived from MIPS if the group TIN is participating in CPC+.

Response: We appreciate the suggestion from the commenter, but note that the exclusions in this final rule with comment period only pertain to new Medicare-enrolled eligible clinicians, QPs and Partial QPs who do not report on applicable MIPS measures and activities, and eligible clinicians who do not exceed the low-volume threshold. We refer readers to section II.E.5.h. of this final rule with comment period, which describes the APM scoring standard for MIPS eligible clinicians participating in MIPS APMs; such provisions are applicable to MIPS eligible clinicians participating in CPC+.

Comment: One commenter requested that CMS allow psychiatrists who participate in ACOs or who work at least 30 percent of their time in eligible integrated care settings to opt out of the reporting requirements to avoid a negative MIPS payment adjustment. Another commenter recommended that CMS exempt from the definition of a MIPS eligible clinician those clinicians participating in all Alternative Payment Models defined in Category 3 of the HCPLAN Alternative Payment Models Framework. The commenter indicated that the exemption should include all upside-gain sharing only models defined in the Framework, including patient-centered medical home models, bundled payment models, and episode of care models.

Response: We note that the statute only allows for certain exclusions for MIPS, two of which are for QPs and Partial QPs participating in an APM or other innovative payment model is not in itself sufficient for an eligible clinician to become a QP or Partial QP. As described in section II.F. of this final rule with comment period, only eligible clinicians who are identified on CMS-maintained lists as participants in Advanced APMs and meet the relevant QP or Partial QP threshold may become QPs or Partial QPs.

After consideration of the public comments we received, we are finalizing the following policies. We are Start Printed Page 77041finalizing the definition at § 414.1305 of a MIPS eligible clinician, as identified by a unique billing TIN and NPI combination used to assess performance, as any of the following (excluding those identified at § 414.1310(b)): A physician (as defined in section 1861(r) of the Act), a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act), a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), and a group that includes such clinicians. We are finalizing our proposed policies at § 414.1310(b) and (c) that QPs, Partial QPs who do not report on applicable measures and activities that are required to be reported under MIPS for any given performance period in a year, low-volume threshold eligible clinicians, and new Medicare-enrolled eligible clinicians as defined at § 414.1305 are excluded from this definition per the statutory exclusions defined in section 1848(q)(1)(C)(ii) and (v) of the Act. In accordance with section 1848(q)(1)(A) and (q)(1)(C)(vi) of the Act, we are finalizing our proposal at § 414.1310(b)(2) to allow eligible clinicians (as defined at § 414.1305) who are not MIPS eligible clinicians the option to voluntarily report measures and activities for MIPS. Additionally, we are finalizing our proposal at § 414.1310(d) that in no case will a MIPS payment adjustment apply to the items and services furnished during a year by individual eligible clinicians, as described in paragraphs (b) and (c) of this section, who are not MIPS eligible clinicians including eligible clinicians who are not MIPS eligible clinicians, but who voluntarily report on applicable measures and activities specified under MIPS.

b. Non-Patient Facing MIPS Eligible Clinicians

Section 1848(q)(2)(C)(iv) of the Act requires the Secretary, in specifying measures and activities for a performance category, to give consideration to the circumstances of professional types (or subcategories of those types determined by practice characteristics) who typically furnish services that do not involve face-to-face interaction with a patient. To the extent feasible and appropriate, the Secretary may take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category to such non-patient facing MIPS eligible clinicians. In carrying out these provisions, we are required to consult with non-patient facing MIPS eligible clinicians.

In addition, section 1848(q)(5)(F) of the Act allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician. We assume many non-patient facing MIPS eligible clinicians will not have sufficient measures and activities applicable and available to report under the performance categories under MIPS. We refer readers to section II.E.6.b.(2) of this final rule with comment period for the discussion regarding how we addressed performance categories weighting for MIPS eligible clinicians for whom no measures exist in a given category.

To establish policies surrounding non-patient facing MIPS eligible clinicians, we must first define the term “non-patient facing.” Currently, the PQRS, VM, and Medicare EHR Incentive Program include two existing policies for considering whether an EP is providing patient-facing services. To determine, for purposes of PQRS, whether an EP had a “face-to-face” encounter with Medicare patients, we assess whether the EP billed for services under the PFS that are associated with face-to-face encounters, such as whether an EP billed general office visit codes, outpatient visits, and surgical procedures. Under PQRS, if an EP bills for at least one service under the PFS during the performance period that is associated with face-to-face encounters and reports quality measures via claims or registries, then the EP is required to report at least one “cross-cutting” measure. EPs who do not meet these criteria are not required to report a cross-cutting measure. For the purposes of PQRS, telehealth services have not historically been included in the definition of face-to-face encounters. For more information, please see the CY 2016 PFS final rule for these discussions (80 FR 71140).

In the Stage 2 final rule (77 FR 54098 through 54099), the Medicare EHR Incentive Program established a significant hardship exception from the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act for EPs that lack face-to-face interactions with patients and those who lack the need to follow-up with patients. EPs with a primary specialty of anesthesiology, pathology or radiology listed in the Provider Enrollment, Chain, and Ownership System (PECOS) as of 6 months prior to the first day of the payment adjustment year automatically receive this hardship exemption (77 FR 54100). Specialty codes associated with these specialties include 05-Anesthesiology, 22-Pathology, 30-Diagnostic Radiology, 36-Nuclear Medicine, 94-Interventional Radiology. EPs with a different specialty are also able to request this hardship exception through the hardship application process. However, telehealth services could be counted by EPs who choose to include these services within the definition of “seen by the EP” for the purposes of calculating patient encounters with the EHR Incentive Program (77 FR 53982).

In the MIPS and APMs RFI (80 FR 63484), we sought comments on MIPS eligible clinicians that should be considered non-patient facing MIPS eligible clinicians and the criteria we should use to identify these MIPS eligible clinicians. Commenters were split when it came to defining and identifying non-patient facing MIPS eligible clinicians. Many took a specialty-driven approach. Commenters generally did not support use of specialty codes alone, which is the approach used by the Medicare EHR Incentive Program. Commenters indicated that these codes do not necessarily delineate between the same specialists who may or may not have patient-facing interaction. One example is cardiologists who specialize in cardiovascular imaging which is also coded as cardiology. On the other hand, as one commenter mentioned, physicians with specialty codes other than “cardiology” (for example, internal medicine) may perform cardiovascular imaging services. Therefore, using the specialty code for cardiology to identify clinicians who typically do not provide patient-facing services would be both over-inclusive and under-inclusive. Other commenters identified specialty types that they believe should be considered non-patient facing MIPS eligible clinicians. Specific specialty types included radiologists, anesthesiologists, nuclear cardiology or nuclear medicine physicians, and pathologists. Others pointed out that certain MIPS eligible clinicians may be primarily non-patient facing MIPS eligible clinicians even though they practice within a traditionally patient-facing specialty. The MIPS and APMs RFI comments and listening sessions with medical societies representing non-patient facing MIPS eligible clinicians specified radiology/imaging, anesthesiology, nuclear cardiology and oncology, and pathology as inclusive of non-patient facing MIPS eligible clinicians. Commenters noted that roles within specific types of specialties may need to be further delineated between patient-facing and non-patient facing Start Printed Page 77042MIPS eligible clinicians. An illustrative list of specific types of clinicians within the non-patient facing spectrum include:

  • Pathologists who may be primarily dedicated to working with local hospitals to identify early indicators related to evolving infectious diseases;
  • Radiologists who primarily provide consultative support back to a referring physician or provide image interpretation and diagnosis versus therapy;
  • Nuclear medicine physicians who play an indirect role in patient care, for example as a consultant to another physician in proper dose administration; or
  • Anesthesiologists who are primarily providing supervision oversight to Certified Registered Nurse Anesthetists.

After reviewing current policies, we proposed to define a non-patient facing MIPS eligible clinician for MIPS at § 414.1305 as an individual MIPS eligible clinician or group that bills 25 or fewer patient-facing encounters during a performance period. We considered a patient-facing encounter as an instance in which the MIPS eligible clinician or group billed for services such as general office visits, outpatient visits, and procedure codes under the PFS. We intend to publish the list of patient-facing encounter codes on a CMS Web site similar to the way we currently publish the list of face-to-face encounter codes for PQRS. This proposal differs from the current PQRS policy in two ways. First, it creates a minimum threshold for the quantity of patient-facing encounters that MIPS eligible clinicians or groups would need to furnish to be considered patient-facing, rather than classifying MIPS eligible clinicians as patient-facing based on a single patient-facing encounter. Second, this proposal includes telehealth services in the definition of patient-facing encounters.

We believed that setting the non-patient facing MIPS eligible clinician threshold for individual MIPS eligible clinician or group at 25 or fewer billed patient-facing encounters during a performance period is appropriate. We selected this threshold based on an analysis of non-patient facing Healthcare Common Procedure Coding System (HCPCS) codes billed by MIPS eligible clinicians. Using these codes and this threshold, we identified approximately one quarter of MIPS eligible clinicians as non-patient facing before MIPS exclusions, such as low-volume and newly-enrolled eligible clinician policies, were applied. The majority of clinicians enrolled in Medicare with specialties such as anesthesiology, nuclear medicine, and pathology were identified as non-patient facing in this analysis. The addition of telehealth to the analysis did not affect the outcome, as it created a less than 0.01 percent change in MIPS eligible clinicians categorized as non-patient facing.

Therefore, the proposed approach allows the definition of non-patient facing MIPS eligible clinicians, to include both MIPS eligible clinicians who practice within specialties traditionally considered non-patient facing, as well as MIPS eligible clinicians who provide occasional patient-facing services that do not represent the bulk of their practices. This definition is also consistent with the statutory requirement that refers to professional types who typically furnish services that do not involve patient-facing interaction with a patient.

In response to the MIPS and APMs RFI, some commenters believed that MIPS eligible clinicians should be defined as non-patient facing MIPS eligible clinicians based on whether their billing indicates they provide face-to-face services. Commenters indicated that the use of specific HCPCS codes in combination with specialty codes, may be a more appropriate way to identify MIPS eligible clinicians that have no patient interaction.

We also proposed to include telehealth services in the definition of patient-facing encounters. Various MIPS eligible clinicians use telehealth services as an innovative way to deliver care to beneficiaries and we believe these services, while not furnished in-person, should be recognized as patient-facing. In addition, Medicare eligible telehealth services substitute for an in-person encounter and meet other site requirements under the PFS as defined at § 410.78.

The proposed addition of the encounter threshold for patient-facing MIPS eligible clinicians was intended to minimize concerns that a MIPS eligible clinician could be misclassified as patient-facing as a result of providing occasional telehealth services that do not represent the bulk of their practice. Finally, we believed that this proposed definition of a non-patient facing MIPS eligible clinician for MIPS could be consistently used throughout the MIPS program to identify those MIPS eligible clinicians for whom certain proposed requirements for patient-facing MIPS eligible clinicians (such as reporting cross-cutting measures) may not be meaningful.

We weighed several options when considering the appropriate definition of non-patient facing MIPS eligible clinicians for MIPS; and some options were similar to those we considered in implementing the Medicare EHR Incentive Program. One option we considered was basing the non-patient facing MIPS eligible clinician's definition on a set percentage of patient-facing encounters, such as 5 to 10 percent, that was tied to the same list of patient-facing encounter codes discussed in this section of this final rule with comment period. Another option we considered was the identification of non-patient facing MIPS eligible clinicians for MIPS only by specialty, which might be a simpler approach. However, we did not consider this approach sufficient for identifying all the possible non-patient facing MIPS eligible clinicians, as some patient-facing MIPS eligible clinicians practice in multi-specialty practices with non-patient facing MIPS eligible clinician's practices with different specialties. We would likely have had to develop a separate process to identify non-patient facing MIPS eligible clinicians in other specialties, whereas maintaining a single definition that is aligned across performance categories is simpler. Many comments from the MIPS and APMs RFI discouraged use of specialty codes alone. Additionally, we believed our proposal would allow us to more accurately identify MIPS eligible clinicians who are non-patient facing by applying a threshold to recognize that a MIPS eligible clinician who furnishes almost exclusively non-patient facing services should be treated as a non-patient facing MIPS eligible clinician despite furnishing a small number of patient-facing services.

In the MIPS and APMs RFI (80 FR 63484), we also requested comments on what types of measures and/or improvement activities (new or from other payment systems) we should use to assess non-patient facing MIPS eligible clinicians' performance and how we should apply the MIPS performance categories to non-patient facing MIPS eligible clinicians. Commenters were split on these subjects. A number of commenters stated that non-patient facing MIPS eligible clinicians should be exempt from specific performance categories under MIPS or should be exempt from MIPS as a whole. Commenters who did not favor exemptions generally suggested that we focus on process measures and work with specialty societies to develop new, more clinically relevant measures for non-patient facing MIPS eligible clinicians.

We took these stakeholder comments into consideration. We note that section 1848(q)(2)(C)(iv) of the Act does not Start Printed Page 77043grant the Secretary discretion to exempt non-patient facing MIPS eligible clinicians from a performance category entirely, but rather to apply to the extent feasible and appropriate alternative measures or activities that fulfill the goals of the applicable performance category. However, we have placed safeguards to ensure that MIPS eligible clinicians, including those who are non-patient facing, who do not have sufficient alternative measures that are applicable and available in a performance category are scored appropriately. We proposed to apply the Secretary's authority under section 1848(q)(5)(F) of the Act to re-weight such performance categories score to zero if there is no performance category score or to lower the weight of the quality performance category score if there are not at least three scored measures. Please refer to section II.E.6.b.(2)(b) in the proposed rule for details on the re-weighting proposals. Accordingly, we proposed alternative requirements for non-patient facing MIPS eligible clinicians across the proposed rule (see sections II.E.5.b., II.E.5.e., and II.E.5.f. of the proposed rule for more details). While non-patient facing MIPS eligible clinicians will not be exempt from any performance category under MIPS, we believe these alternative requirements fulfill the goals of the applicable performance categories and are in line with the commenters' desire to ensure that non-patient facing MIPS eligible clinicians are not placed at an unfair disadvantage under the new program. The requirements also build on prior program components in meaningful ways and are meant to help us appropriately assess and incentivize non-patient facing MIPS eligible clinicians. We requested comments on these proposals.

The following is a summary of the comments we received regarding our proposal that defines non-patient facing MIPS eligible clinicians for MIPS as an individual MIPS eligible clinician or group that bills 25 or fewer patient-facing encounters (including telehealth services) during a performance period.

Comment: A few commenters supported the proposed definition of non-patient facing MIPS eligible clinicians.

Response: We appreciate the support from commenters.

Comment: One commenter requested that pathologists (as identified in PECOS) be automatically identified as non-patient facing MIPS eligible clinicians at the beginning of each year. The commenter noted that it seems reasonable to use PECOS to identify non-patient facing specialties.

Response: We appreciate the commenter expressing the importance for MIPS eligible clinicians to be identified as non-patient facing MIPS eligible clinicians at the beginning of each year. We believe that it would be beneficial for individual MIPS eligible clinicians and groups to know in advance of a performance period whether or not they qualify as a non-patient facing MIPS eligible clinician. For purposes of this section, we are coining the term “non-patient facing determination period” to refer to the timeframe used to assess claims data for making eligibility regarding non-patient facing status. We define the non-patient facing determination period to mean a 24-month assessment period, which includes a two-segment analysis of claims data regarding patient-facing encounters during an initial 12-month period prior to the performance period followed by another 12-month period during the performance period.

The initial 12-month segment of the non-patient facing determination period would span from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and include a 60-day claims run out, which will allow us to inform eligible clinicians and groups of their non-patient status during the month (December) prior to the start of the performance period. We believe that the initial non-patient facing determination period enables us to make eligibility determinations based on 12 months of data that is as close to the performance period as possible while informing eligible clinicians of their non-patient facing status prior to the performance period. The second 12-month segment of the non-patient facing determination period would span from the last 4 months of a calendar year 1 year prior to the performance period followed by the first 8 months of the performance period in the next calendar year and include a 60-day claims run out, which will allow us to inform additional eligible clinicians and groups of their non-patient status during the performance period.

Thus, for purposes of the 2019 MIPS payment adjustment, we will initially identify individual eligible clinicians and groups who are considered non-patient facing MIPS eligible clinicians based on 12 months of data starting from September 1, 2015 to August 31, 2016. In order to account for the identification of additional individual eligible clinicians and groups that may qualify as non-patient facing during the 2017 performance period, we will conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2016 to August 31, 2017.

Comment: One commenter requested that CMS consider allowing physicians in other specialties to declare by exception that they deserve a similar exemption as those that are identified in the proposed rule as non-patient facing MIPS eligible clinicians, which can be confirmed by CMS through coding analysis.

Response: We disagree with the approach described by the commenter because the statute does not provide discretion in establishing exclusions other than the three exclusions specified in section II.E.3. of this final rule with comment period. Also, we note that non-patient facing MIPS eligible clinicians are identified based on an analysis we conduct using claims data to determine such status; this is not a status that clinicians make an election for purposes of MIPS.

Comment: Many commenters expressed concerns that the threshold set forth in the proposed definition of a non-patient facing MIPS eligible clinician (for example, an individual MIPS eligible clinician or group that bills 25 or fewer patient-facing encounters during a performance period) was too low. The commenters believed that many clinicians in certain specialties would be classified as patient-facing even though clinicians in those specialties are predominately non-patient facing. One commenter stated that MIPS eligible clinicians with such a low number of patient-facing encounters may not realize they would be considered patient-facing and subject to additional reporting requirements. Many commenters recommended alternative options for establishing a threshold relating to the billing of patient-facing encounters, including the following: A threshold of 50 or fewer patient-facing encounters; a threshold of 100 or fewer patient-facing encounters, which would represent a somewhat larger portion of the MIPS eligible clinician's practice, averaging approximately two patient-facing encounters per week; and a threshold of 150 or fewer billed Medicare patient-facing encounters. Other commenters suggested that CMS consider automatically designating certain specialties, such as anesthesiology or radiology, as non-patient facing unless a clinician in such specialty bills more than 100 patient-facing encounters. One commenter suggested that CMS base the threshold on a percentage of patients seen (for example, 80 percent of services furnished are determined to be non-patient facing) or claims or allowed Start Printed Page 77044charges (for example, 85 percent of claims or charges are for non-patient facing services), or a combination of the two percentage-based options.

Response: We thank the commenters for expressing their concerns and recommendations regarding the proposed threshold used to define a non-patient facing MIPS eligible clinician. Based on the comments indicating that the proposed threshold would misclassify certain specialties that are predominately non-patient facing, and in order to more accurately identify MIPS eligible clinicians who are non-patient facing, we are modifying our proposal and increasing the threshold to determine when a MIPS eligible clinician is considered non-patient facing. Therefore, we are finalizing a modification to our proposal to define a non-patient facing MIPS eligible clinician as an individual MIPS eligible clinician that bills 100 or fewer patient-facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act) during the non-patient facing determination period, and a group provided that more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period. We believe that the 100 or fewer billed patient-facing encounters as a threshold more accurately reflects a differentiation of annual patient-facing encounters between MIPS eligible clinicians who furnish a majority of patient-facing services and considered patient-facing and MIPS eligible clinicians who provide occasional patient-facing services that do not reflect the bulk of services provided by the practice or would traditionally be considered non-patient facing. This modified threshold that applies at the individual level would reduce the risk of identifying individual MIPS eligible clinicians as patient-facing who would otherwise be considered non-patient facing. Similarly, the modified threshold that applies at the group level as previously noted, would reduce the risk of identifying groups as patient-facing that would otherwise be considered non-patient facing. Also, we considered increasing the threshold based on different approaches. As previously described, one option was basing the definition of a non-patient facing MIPS eligible clinician on a set percentage of patient-facing encounters, such as 5 to 10 percent, that was tied to the same list of patient-facing encounter codes discussed in this section of the final rule with comment period. We did not pursue this approach because a percentage would not apply consistency, which could miscategorize MIPS eligible clinicians who would otherwise be considered patient-facing. Another option we considered was the identification of non-patient facing MIPS eligible clinicians only by specialty, which might be a simpler approach. However, we did not consider this approach sufficient for identifying all the possible non-patient facing MIPS eligible clinicians, as some patient-facing MIPS eligible clinicians practice in multi-specialty practices with non-patient facing MIPS eligible clinician's practices with different specialties. We would likely have had to develop a separate process to identify non-patient facing MIPS eligible clinicians in other specialties, whereas maintaining a single definition that is aligned across performance categories is simpler. Thus, we did not modify our approach along these lines.

Comment: In regard to the illustrative list of specific types of clinicians within the non-patient facing spectrum outlined in the proposed rule, one commenter requested that CMS remove the reference to anesthesiologist supervision and ensure that the Quality Payment Program would not impose any unnecessary supervision. The commenter noted that physician supervision of nurse anesthetists did not improve care outcomes and was therefore unnecessary. Another commenter stated that most anesthesiologists should be designated as non-patient facing and recommended that CMS reconsider the non-patient facing determination criteria while another commenter requested that CMS ensure the equal treatment of certified registered nurse anesthetists and anesthesiologists when determining who qualifies as a non-patient facing MIPS eligible clinician. One commenter suggested that CMS publish the list of patient-facing services as quickly as possible in order for anesthesiologists to determine if they are considered non-patient facing MIPS eligible clinicians. The commenter requested that CMS provide details on how it estimated that a majority of anesthesiologists would qualify as non-patient facing.

Response: We appreciate the suggestions from commenters regarding the types of MIPS eligible clinicians to be considered non-patient facing. We want to clarify that our proposed definition of a non-patient facing MIPS eligible clinician did not include the identification of any specific type of physician or clinician specialty, and note that the statutory definition of an anesthesiologist does not specify a supervision requisite as a requirement. However, our proposed definition of a non-patient facing MIPS eligible clinician is based on a methodology that would allow us to more accurately identify MIPS eligible clinicians who are non-patient facing by applying a threshold to recognize that a MIPS eligible clinician who furnishes almost exclusively non-patient facing services should be treated as a non-patient facing MIPS eligible clinician despite furnishing a small number of patient-facing services. Our methodology used to identify non-patient facing MIPS eligible clinicians included a quantitative, comparative analysis of claims and HCPCS code data. Contrary to the commenter's belief, we believe that our proposed definition of a non-patient facing clinician would not capture the majority of MIPS eligible clinicians or groups within specialties such as anesthesiology, pathology, radiology, and nuclear medicine who may provide a small portion of services that would be considered patient-facing, but would otherwise be considered non-patient facing MIPS eligible clinicians. As a result of this dynamic, we are finalizing a modification to our proposed definition of a non-patient facing MIPS eligible clinician. As previously noted, we will identify MIPS eligible clinicians who are considered non-patient facing in advance of the performance period.

Comment: One commenter requested that MIPS eligible clinicians within the interventional pain management specialty be exempt from negative, but not positive, MIPS payment adjustments. The commenter noted that MIPS will destroy independent practices and increase the costs of Medicare, making Medicare insolvent even sooner than expected.

Response: We thank the commenter for the suggestion. We note that the statute does not grant the Secretary discretion to exclude non-patient facing MIPS eligible clinicians from the requirement to participate in MIPS. However, non-patient facing MIPS eligible clinicians will benefit from other policies that we are finalizing throughout this final rule with comment period such as reduced performance requirements and lower performance threshold. Accordingly, we describe alternative requirements for non-patient facing MIPS eligible clinicians across this final rule with comment period (see sections II.E.5.b., II.E.5.e., and II.E.5.f. of this final rule with comment period for more details). We disagree with the comment regarding MIPS negatively impacting independent practices. We Start Printed Page 77045believe that independent practices will benefit from other policies that we are finalizing throughout this final rule with comment period such as reduced performance requirements and lower performance threshold.

Comment: One commenter requested that CMS abandon the term “non-patient facing” in reference to MIPS eligible clinicians or physician specialties. The commenter indicated that the patient-facing/non-patient facing terminology is appropriate for describing the Current Procedural Terminology (CPT) code, but not appropriated for describing a clinician relative to quality improvement. Another commenter recommended that CMS consider an alternative term to “non-patient facing” as it applies to anesthesiologists. One commenter expressed concern that the term non-patient facing diminishes the importance of specialists.

Response: We appreciate the commenters expressing their concerns regarding the use of the term “non-patient facing” and as a result of the concerns from commenters, we are interested in obtaining further input from stakeholders regarding potential terms that could be used to describe “non-patient facing” under MIPS. Therefore, we are seeking additional comment on modifying the terminology used to reference “non-patient facing” MIPS eligible clinicians for future consideration. What alternative terms could be used to describe “non-patient facing”?

Comment: One commenter indicated that the proposed definition of non-patient facing clinicians is overly stringent and does not recognize a number of “hybrid” physicians such as nuclear cardiologists, who split time between patient-facing and non-patient facing activity. The commenter requested an alternative pathway for “hybrid” physicians in order for nuclear cardiologists and others to successfully participate in MIPS, which is important for medical specialists with no alternative payment models. As an interim solution, the commenter requested that the reporting period be shortened and be flexibility for MIPS eligible clinicians to select the reporting period within the applicable calendar year.

Response: We thank the commenter for expressing concerns and recognize that MIPS eligible clinicians in certain specialties may not have a majority of their services categorized as non-patient facing. We want to ensure that MIPS eligible clinicians, including non-patient facing MIPS eligible clinicians are able to participate in MIPS successfully and thus, in this final rule with comment period, we not only establish requirements for MIPS eligible clinicians in each performance category, but we apply, to the extent feasible and appropriate, alternative measures or activities that fulfill the goals of each performance category. In sections II.E.5.b., II.E.5.e., and II.E.5.f. of this final rule with comment period, we describe the alternative requirements for non-patient facing MIPS eligible clinicians. Also, as described in section II.E.4. of this final rule with comment period, we are finalizing a modification to the MIPS performance period to be a minimum of one continuous 90-day period within CY 2017.

Comment: Several commenters indicated that the definition of a non-patient facing MIPS eligible clinician is inadequate since the definition is dependent on the codes that define patient-facing encounters, which are not yet available. The commenters requested that CMS provide the applicable CPT codes as soon as possible in order for affected MIPS eligible clinicians to have sufficient time to assess the alignment of the codes. One commenter recommended that only evaluation and management services (the denominators of the cross-cutting measures as specified in Table C: Proposed Individual Quality Cross-Cutting Measures for the MIPS to Be Available to Meet the Reporting Criteria Via Claims, Registry, and EHR Beginning in 2017 of the proposed rule (81 FR 28447 through 28449)) be considered when determining whether a MIPS eligible clinician provides face-to-face services. The commenter indicated that the inclusion of other services, particularly 000 global codes, will inappropriately classify many radiologists as patient-facing and put small and rural practices at a distinct disadvantage.

Response: We thank the commenters for their support and expressing their concerns. While we did not propose specific patient-facing encounter codes in the proposed rule, we considered a patient-facing encounter to be an instance in which the MIPS eligible clinician or group billed for items and services furnished such as general office visits, outpatient visits, and procedure codes under the PFS. We agree with the commenters that a non-patient facing MIPS eligible clinician is identified based on the evaluation and management of services, which reflects the list of patient-facing encounter codes. We note that the denominators, as specified in Table C of the proposed rule, used for determining the non-patient facing status of MIPS eligible clinicians are the same as the denominators of the cross-cutting measures. Based on our experience with PQRS, we believe that the use of patient-facing encounter codes is the most appropriate approach for determining whether or not MIPS eligible clinicians are non-patient facing. We intend to publish a list of patient-facing encounters on the CMS Web site located at QualityPaymentProgram.cms.gov.

In regard to the comment pertaining to misclassification, we note that the definition of non-patient facing MIPS eligible clinicians creates a minimum threshold for the quantity of patient-facing encounters that MIPS eligible clinicians or groups would need to furnish to be considered patient-facing, rather than classifying MIPS eligible clinicians as patient-facing based on a single patient-facing encounter. This approach allows for the definition of non-patient facing MIPS eligible clinicians to include both MIPS eligible clinicians who practice within specialties traditionally considered non-patient facing as well as MIPS eligible clinicians who provide occasional patient-facing services that do not represent the bulk of their practices. We believe our modified policy will allow us to more accurately identify MIPS eligible clinicians who are non-patient facing by applying a threshold in recognition of the fact that a MIPS eligible clinician who furnishes almost exclusively non-patient facing services should be treated as a non-patient facing MIPS eligible clinician despite furnishing a small number of patient-facing services.

Comment: One commenter requested clarification on whether or not the definition of a patient-facing encounter includes procedures such as peripheral nerve blocks (64400-64530) and epidural injections (62310-62319).

Response: We intend to publish the list of patient-facing encounters on the CMS Web site located at QualityPaymentProgram.cms.gov, which will include procedures such as peripheral nerve blocks (64400-64530) and epidural injections (62310-62319).

Comment: One commenter requested that CMS justify how 25 or fewer patient-facing encounters was determined as the threshold for non-patient facing MIPS eligible clinicians.

Response: As previously noted, we believed that setting the non-patient facing MIPS eligible clinician threshold for individual MIPS eligible clinician or group at 25 or fewer billed patient-facing encounters during a performance period was appropriate. We selected this threshold based on an analysis of Start Printed Page 77046non-patient facing HCPCS codes billed by MIPS eligible clinicians. Using these codes and this threshold, we determined that approximately one quarter of MIPS eligible clinicians would be identified as non-patient facing before MIPS exclusions, such as the low-volume threshold and new Medicare-enrolled eligible clinician policies, were applied. Based on our analysis, a significant portion of clinicians enrolled in Medicare with specialties such as anesthesiology, nuclear medicine, and pathology were identified as non-patient facing in this analysis. We believe that our approach allows the definition of non-patient facing MIPS eligible clinicians, to include both MIPS eligible clinicians who practice within specialties traditionally considered non-patient facing, as well as MIPS eligible clinicians who provide occasional patient-facing services that do not represent the bulk of their practices.

However, as discussed above, we are finalizing a modification to our proposal to define a non-patient facing MIPS eligible clinician as an individual MIPS eligible clinician that bills 100 or fewer patient-facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act) during the non-patient facing determination period, and a group provided that more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period. When we applied our prior methodology to make determinations at the group level, the percentage of MIPS eligible clinicians classified as non-patient facing at the group level was higher because at the group level, MIPS eligible clinicians with less than 100 encounters who would otherwise be considered patient-facing (for example, pediatricians) are included in the group level calculation for the non-patient facing determination. Thus, there would be more specialists classified as non-patient facing when we make determinations at the group level, particularly when the percentage of specialists identified as non-patient facing at the group level is compared to the overall percentage of individual MIPS eligible clinicians. We note that the reason for the increase in the number of non-patient facing determinations is due to individual MIPS eligible clinicians in groups who have with less than 100 encounters would be classified as non-patient facing and would otherwise be considered patient-facing.

Comment: Several commenters disagreed with CMS's proposal to apply the same billing threshold for patient-facing encounters to both individual MIPS eligible clinicians and groups. One commenter noted that such a policy would force groups of non-patient facing MIPS eligible clinicians to be required to report on inapplicable outcomes and cross-cutting measures if several individuals' rare face-to-face patient encounters are summed as a group (for example, a group of 10 physicians with 2 to 3 face-to-face patient encounters per year per MIPS eligible clinician). Another commenter specifically indicated that if the proposed non-patient facing threshold is applied at a group level, specialties such as diagnostic radiology, pathology, nuclear medicine, and anesthesiology would be considered patient-facing even though practices in these specialties could be considered non-patient facing if evaluated individually.

A few commenters indicated that when the proposed threshold is applied to groups without scaling the threshold by the number of clinicians in a group, a single individual clinician could push the entire group into the patient-facing category, even if the other individual clinicians in the group would, otherwise, be considered non-patient facing. One commenter indicated that the proposed definition of a non-patient facing MIPS eligible clinician would impact small and rural practices whose general radiologists perform more interventional procedures even though such patient-facing encounters represent only a very small fraction of the group's total Medicare services.

Several commenters provided alternative options for determining how the definition of non-patient facing MIPS eligible clinicians could be applied to groups. One commenter suggested scaling the patient-facing encounter threshold by the number of clinicians in a group practice while another commenter suggested doing so by patient-facing encounter codes. A few other commenters recommended one or more of the following alternatives: (1) Apply a patient-facing encounter threshold that is proportional to the group size, and, for non-patient facing MIPS eligible clinicians who meet the definition, identify such MIPS eligible clinicians at the beginning of the performance year; (2) classify groups based on whether the majority of individual MIPS eligible clinicians meet the threshold; (3) compare a group's average number of patient-facing encounters to the threshold, where a group's average would be defined by the total number of patient-facing encounters billed by the group divided by the number of MIPS eligible clinicians in the group and as a result, would not be skewed by a few MIPS eligible clinicians; or (4) redefine a non-patient facing MIPS eligible clinician by using the threshold of 50 or fewer patient-facing encounters per individual such that, if 51 percent or more members of the group individually fall below the threshold, then the entire group is considered non-patient facing.

Response: We thank the commenters for expressing their concerns regarding the proposed definition of a non-patient facing MIPS eligible clinician. Based on the comments received, we recognize that having a similar threshold applied at the individual and group levels would inadvertently identify groups composed of certain specialties or multi-specialties as patient-facing that would traditionally be considered non-patient facing or provide occasional patient-facing services that do not represent the bulk of their group. Thus, we are modifying our proposed definition of a non-patient facing MIPS eligible clinician to establish two separate thresholds that apply at the individual and group level.

Specifically, we are modifying our proposal to define a non-patient facing MIPS eligible clinician for MIPS as an individual MIPS eligible clinician that bills 100 or fewer patient-facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act) during the non-patient facing determination period, and a group provided that more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period.

In regard to the threshold applying at the group level, we recognize that groups vary in size and composition and thus, we believe that a percentage-based approach applies such a threshold equally across all types of groups. Also, we believe that a percentage-based threshold for groups is a more appropriate and accurate approach for distinguishing between groups composed of certain specialty or multi-specialty practices that should be considered non-patient facing. We are establishing a percentage-based threshold pertaining to groups above 75 percent in order to succinctly identify whether or not the majority of services furnished by groups are non-patient facing. We are specifying that more than 75 percent of the NPIs billing under the group's TIN would need to meet the Start Printed Page 77047definition of a non-patient facing individual MIPS eligible clinician in order for the group to be considered non-patient facing because such a threshold is applicable to any group size and composition and clearly delineates which groups furnish primarily non-patient facing services while remaining consistent with the individual-level threshold. For purposes of defining a non-patient facing MIPS eligible clinician as it relates to groups, we believe that more than 75 percent is an adequate percentage threshold. Based on the comments received regarding the establishment of a separate non-patient facing threshold for groups, we are seeking additional comment on our modified policy for future consideration, which determines that a group would be considered non-patient facing if more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period.

Comment: One commenter indicated that clarification is needed on how the requirements for each performance category would apply to clinicians who do not have face-to-face encounters with patients.

Response: We refer readers to sections II.E.5.b., II.E.5.e., and II.E.5.f. of this final rule with comment period, which describe the requirements for each performance category pertaining to non-patient facing MIPS eligible clinicians.

Comment: One commenter inquired about whether or not CMS would be able to distinguish claims for patient-facing encounters from claims for non-patient facing encounters to ensure that Part B claims for non-patient facing encounters are not subject to the MIPS payment adjustment.

Response: The statute makes it clear that the MIPS payment adjustment applies to the amount otherwise paid under Medicare Part B charges with respect to items and services furnished by a MIPS eligible clinician during a year. We note that here is no carve-out for amounts paid for claims for non-patient facing services given that the statute does not grant the Secretary discretion to establish such a carve-out through rulemaking.

Comment: One commenter requested that CMS include safeguards that prevent unintended consequences of scoring newly introduced quality measures. Specifically, the commenter indicated that the three proposed population-based measures have rarely been, or ever, reported by physician anesthesiologists. The three measures—Acute Conditions Composite (Bacterial Pneumonia, Urinary Tract Infection and Dehydration), Chronic Conditions Composite (Diabetes, Chronic Obstructive Pulmonary Disease or Asthma, Heart Failure) and All-cause Hospital Readmission Measure are measures that the physician anesthesiologist would have little control over, especially since these measures are calculated by CMS using administrative claims data. The commenter indicated that the use of these measures would place anesthesiology at a disadvantage to other MIPS eligible clinicians. The commenter expressed concern that attribution of these measures to individual physician anesthesiologists may prove to be equally or less transparent than current measures under VM.

Response: We appreciate the commenter's concerns and note that, as discussed in section II.E.5.b.(4) of this final rule with comment period, we are establishing alternative requirements under the quality performance category for non-patient facing MIPS eligible clinicians. As discussed in section II.E.6.b.(2) of this final rule with comment period, we may re-weight performance categories if there are not sufficient measures applicable and available for each MIPS eligible clinician in order to ensure that all MIPS eligible clinicians, including those who are non-patient facing, are scored appropriately. Lastly, as discussed in section II.E.5.b.(6) of this final rule with comment period, we note that 2 of the 3 proposed population measures are not being finalized. In section II.E.8.e. of this final rule with comment period, we describe a validation process for claims and registry submissions to validate whether MIPS eligible clinicians have submitted all applicable measures when MIPS eligible clinicians submit fewer than six measures.

Comment: One commenter requested clarification on how MIPS incentives or penalties would be applied when facilities (for example, hospitals) bill and collect the Medicare Part B payments through reassignment from their hospital-based MIPS eligible clinicians. The commenter indicated that as hospitals continue to employ primary care clinicians and specialists and bill payers on their behalf, hospitals are concerned that their Medicare Part B payments will be subject to MIPS payment adjustments for poor final scores. The commenter inquired about whether a hospital-based clinician would be required to participate in MIPS. The commenter recommended that CMS consider the consequences of applying a MIPS payment adjustment factor that may adversely affect financially vulnerable hospitals, such as safety net hospitals.

Response: We appreciate the commenter expressing concerns. We note that the requirements described in this final rule with comment period apply to MIPS eligible clinicians participating in MIPS as individual MIPS eligible clinicians or groups and do not apply to hospitals directly. In regard to the commenter's concern about the MIPS payment adjustment affecting financially vulnerable hospitals and safety net hospitals, section 1848(q)(6)(E) of the Act provides that the MIPS payment adjustment is applied to the amount otherwise paid under Part B for the items and services furnished by a MIPS eligible clinician during a year (beginning with 2019). Thus, the MIPS payment adjustment would apply to payments made for items and services furnished by MIPS eligible clinicians for Medicare Part B charges billed such as those under the PFS, but it would not apply to the facility payment to the hospital itself under the inpatient prospective payment system (IPPS) or other facility-based payment methodology. We refer readers to sections II.E.1.c. and II.E.1.d. of this final rule with comment period, which address MIPS eligible clinicians who practice in Method I CAHs, Method II CAHs, RHCs, and FQHCs.

Comment: A commenter suggested that CMS focus on inpatient care, rather than outpatient care, because savings are more achievable in the inpatient setting (particularly in the last 6 months of life). The commenter noted that the MIPS program should track hospitals, rather than clinicians.

Response: We appreciate the suggestions from the commenter and will consider them into consideration in future rulemaking.

Comment: Several commenters supported the inclusion of telehealth services as patient-facing encounters. A few commenters described the potential benefits of telehealth, including: Increasing access to health care services that otherwise may not be available to many patients, reducing avoidable hospitalizations for nursing facility residents who otherwise may not receive early enough treatment, and providing an option to help address clinician shortages. Another commenter expressed concern that telehealth would become common and is not a viable substitute for face-to-face patient care.

A few commenters discussed the definition of telehealth. One commenter recommended a revision to the current Medicare telehealth definition to reflect simple, plain language for MIPS Start Printed Page 77048reporting and suggested the following, “Telehealth means a health care service provided to a patient from a provider at other location.” Another commenter requested that CMS define and adopt a technology neutral definition of telehealth that would allow MIPS eligible clinicians to report the full range of evidence-based telehealth services they provide, rather than limiting MIPS telehealth reporting to be “Medicare eligible telehealth services” as defined at 42 CFR 410.78. One commenter requested that CMS expand the definition, use, and reporting of telehealth services, and clearly distinguish between MIPS eligible clinicians who are and are not patient-facing (for example, radiology, physician-to-physician consult). Another commenter suggested that CMS publish, at the beginning of a performance year, a comprehensive list of each telehealth service cross-mapped to whether it is determined to be patient-facing or non-patient facing.

Also, a few commenters recommended that telehealth services should be restricted to true direct patient encounters (which would count toward a threshold of patient-facing encounters) and exclude the use of telehealth services by clinicians to consult with one another. One commenter disagreed with the eligibility criteria for telehealth services in contributing towards the scoring of the four performance categories and recommended that CMS treat telehealth services the same as all other in-person services for purposes of calculating MIPS program requirements.

Response: We appreciate the support from commenters regarding our proposal to include telehealth services in the definition of patient-facing encounters. We note that telehealth services means the Medicare telehealth services defined in section 1834(m) of the Act. Under the PFS and for purposes of this final rule with comment period, Medicare telehealth services that are evaluation and management services (the denominators for the cross-cutting measures) are considered patient-facing encounters, which will be made available at QualityPaymentProgram.cms.gov. The list of all Medicare telehealth services is located on the CMS Web site at https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​Telehealth-Codes.html. For eligible telehealth services, the use of telecommunications technology (real-time audio and video communication) substitutes for an in-person encounter. Services furnished with the use of telecommunications technology that do not use a real-time interactive communication between a patient and clinician are not considered telehealth services. Such services encompass circumstances in which a clinician would be able to assess an aspect of a patient's condition without the presence of the patient or without the interposition of another clinician. In regard to the recommendation from commenters requesting CMS to modify the definition of telehealth, we note that section 1834(m) of the Act defines Medicare telehealth services and we believe this is the appropriate definition for purposes of delineating the scope of patient-facing encounters.

Comment: One commenter requested that the registration process for non-patient facing MIPS eligible clinicians be very clear, and noted that it is difficult to register in more than one place with multiple logins and passwords. The commenter requested that CMS make sure that the personnel handling the Quality Payment Program Service Center have knowledge of areas such as pathology and radiology. The commenter also recommended that CMS reach out to the specialty clinician community in order for specialists to know that they need to register.

Response: We did not propose a registration process for non-patient facing MIPS eligible clinicians. All MIPS eligible clinicians who meet the definition of a non-patient facing MIPS eligible clinician will be considered non-patient facing for the duration of a performance period. In order for non-patient facing MIPS eligible clinicians to know in advance of a performance period whether or not they qualify as a non-patient facing MIPS eligible clinician, we will identify non-patient facing individual MIPS eligible clinicians and groups based on the 24-month non-patient facing determination period. The non-patient facing determination period has an initial 12-month segment that would span from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and include a 60-day claims run out, which will allow us to inform MIPS eligible clinicians and groups of their non-patient facing status during the month (December) prior to the start of the performance period.

For purposes of the 2019 MIPS payment adjustment, we will initially identify individual MIPS eligible clinicians and groups who are considered non-patient facing MIPS eligible clinicians based on 12 months of data starting from September 1, 2015 to August 31, 2016. In order to account for the identification of additional individual MIPS eligible clinicians and groups that may qualify as non-patient facing during the 2017 performance period, we will conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2016 to August 31, 2017. In regard to the suggestion regarding the Quality Payment Program Service Center, we strive to ensure that any MIPS eligible clinician or group that will seeks assistance through the Quality Payment Program Service Center will be provided with adequate and consistent information pertaining to the various components of MIPS.

After consideration of the public comments we received, we are finalizing a modification to our proposal to define a non-patient facing MIPS eligible clinician for MIPS at § 414.1305 as an individual MIPS eligible clinician that bills 100 or fewer patient-facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act) during the non-patient facing determination period, and a group provided that more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period. As noted above, we believe that it would be beneficial for individual MIPS eligible clinicians and groups to know in advance of a performance period whether or not they qualify as a non-patient facing MIPS eligible clinician.

We establish the non-patient facing determination period for purposes of identifying non-patient facing MIPS eligible clinicians in advance of the performance period using historical claims data. This eligibility determination process will allow us to identify non-patient facing MIPS eligible clinicians prior to or shortly after the start of the performance period. In order to conduct an analysis of the data prior to the performance period, we are establishing an initial non-patient facing determination period consisting of 12 months. The initial 12-month segment of the non-patient facing determination period would span from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and include a 60-day claims run out, which will allow us to inform MIPS eligible clinicians and groups of their non-patient facing status during the month (December) prior to the start of the performance period. The second 12-month segment of the non-patient facing determination period would span from the last 4 months of a calendar year 1 year prior to the performance period followed by the first Start Printed Page 770498 months of the performance period in the next calendar year and include a 60-day claims run out, which will allow us to inform additional eligible clinicians and groups of their non-patient status during the performance period.

Thus, for purposes of the 2019 MIPS payment adjustment, we will initially identify individual MIPS eligible clinicians and groups who are considered non-patient facing MIPS eligible clinicians based on 12 months of data starting from September 1, 2015 to August 31, 2016. In order to account for the identification of additional individual MIPS eligible clinicians and groups that may qualify as non-patient facing during the 2017 performance period, we will conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2016 to August 31, 2017.

Similarly, for future years, we will conduct an initial eligibility determination analysis based on 12 months of data (consisting of the last 4 months of the calendar year 2 years prior to the performance period and the first 8 months of the calendar year prior to the performance period) to determine the non-patient facing status of individual MIPS eligible clinicians and groups, and conduct another eligibility determination analysis based on 12 months of data (consisting of the last 4 months of the calendar year prior to the performance period and the first 8 months of the performance period) to determine the non-patient facing status of additional individual MIPS eligible clinicians and groups. We will not change the non-patient facing status of any individual MIPS eligible clinician or group identified as non-patient facing during the first eligibility determination analysis based on the second eligibility determination analysis. Thus, an individual MIPS eligible clinician or group that is identified as non-patient facing during the first eligibility determination analysis will continue to be considered non-patient facing for the duration of the performance period regardless of the results of the second eligibility determination analysis. We will conduct the second eligibility determination analysis to account for the identification of additional, previously unidentified individual MIPS eligible clinicians and groups that are considered non-patient facing.

In addition, we consider a patient-facing encounter as the evaluation and management services (the denominators for the cross-cutting measures). Lastly, as noted above, we are finalizing our proposal to include Medicare telehealth services (as defined in section 1834(m) of the Act) in the definition of patient-facing encounters. We intend to publish a list of patient-facing encounters on the CMS Web site located at QualityPaymentProgram.cms.gov.

c. MIPS Eligible Clinicians Who Practice in Critical Access Hospitals Billing Under Method II (Method II CAHs)

Section 1848(q)(6)(E) of the Act provides that the MIPS payment adjustment is applied to the amount otherwise paid under Part B for the items and services furnished by a MIPS eligible clinician during a year (beginning with 2019). In the case of MIPS eligible clinicians who practice in CAHs that bill under Method I (“Method I CAHs”), the MIPS payment adjustment would apply to payments made for items and services billed by MIPS eligible clinicians under the PFS, but it would not apply to the facility payment to the CAH itself. In the case of MIPS eligible clinicians who practice in Method II CAHs and have not assigned their billing rights to the CAH, the MIPS payment adjustment would apply in the same manner as for MIPS eligible clinicians who bill for items and services in Method I CAHs.

Under section 1834(g)(2) of the Act, a Method II CAH bills and is paid for facility services at 101 percent of its reasonable costs and for professional services at 115 percent of such amounts as would otherwise be paid under Part B if such services were not included in outpatient CAH services. In the case of MIPS eligible clinicians who practice in Method II CAHs and have assigned their billing rights to the CAHs, those professional services would constitute “covered professional services” under section 1848(k)(3)(A) of the Act because they are furnished by an eligible clinician and payment is “based on” the PFS. Moreover, this is consistent with the precedent CMS has established by applying the PQRS and meaningful use payment adjustments to Method II CAH payments. Therefore, we proposed that the MIPS payment adjustment does apply to Method II CAH payments under section 1834(g)(2)(B) of the Act when MIPS eligible clinicians who practice in Method II CAHs have assigned their billing rights to the CAH. We requested comments on this proposal.

The following is a summary of the comments we received regarding our proposal that the MIPS payment adjustment does apply to Method II CAH payments under section 1834(g)(2)(B) of the Act when MIPS eligible clinicians who practice in Method II CAHs have assigned their billing rights to the CAH.

Comment: One commenter requested clarification regarding whether or not clinicians who are part of a CAH would be considered a group and required to participate MIPS.

Response: We note that clinicians meeting the definition of a MIPS eligible clinician unless eligible for an exclusion, are generally required to participate in MIPS. For MIPS eligible clinicians who practice in Method I CAHs, the MIPS payment adjustment would apply to payments made for items and services that are Medicare Part B charges billed by MIPS eligible clinicians, but it would not apply to the facility payment to the CAH itself. For MIPS eligible clinicians who practice in Method II CAHs and have not assigned their billing rights to the CAH, the MIPS payment adjustment would apply in the same manner as for MIPS eligible clinicians who bill for items and services in Method I CAHs. Moreover, in this final rule with comment period, we are finalizing our proposal that the MIPS payment adjustment does apply to Method II CAH payments under section 1834(g)(2)(B) of the Act when MIPS eligible clinicians who practice in Method II CAHs have assigned their billing rights to the CAH. We note that if a CAH is reporting as a group, then MIPS eligible clinicians part of a CAH would be considered a group as defined at § 414.1305.

Comment: Several commenters stated that CMS must address the problems with Method II Critical Access Hospital reporting prior to Quality Payment Program implementation, particularly relating to the attribution methodology and data capture issues. For example, commenters suggested that CMS examine whether there are mechanisms for better capturing information on MIPS eligible clinicians from the CMS-1450 form. Another commenter expressed concerns that Method II CAH participation in PQRS did not work as planned and the same issues may affect Method II CAH participation in the Quality Payment Program such as attribution issues may arise when any portion of the items and services furnished by eligible clinicians are excluded from Medicare's claims data database. The commenter believed that cost and quality measures are skewed because most patients attributed to Method II CAH facilities are institutionalized, causing them to appear to have much higher costs and lower quality than the average, and because not all CAH services are reported on CMS-1500 claim forms. Specifically, commenters indicated that Method II CAHs see only a small portion of their services reimbursed Start Printed Page 77050under Medicare Part B, including hospital inpatient, swing bed, nursing home, psychiatric and rehabilitation inpatient, and hospital outpatient services rendered in non-CAH settings. Services rendered for outpatients in the CAH setting (for example provider-based clinic, observation, emergency room, surgery, etc.) are reimbursed through Part A and are exempt from the Quality Payment Program. The commenters noted that this results in beneficiaries who are less acute and low cost to the Medicare program (those seen in clinic settings and those who have avoided inpatient and post-acute care settings) being excluded in the Quality Payment Program attribution, with only potentially high-cost beneficiaries being counted. Therefore, while a CAH-based eligible clinician may have a substantial portion of his or her patient population in a low-cost category, the use of the PQRS attribution methodology for MIPS could still easily result in the MIPS eligible clinician being reported as high-cost if only high-cost patients are included in the Quality Payment Program attribution. The commenters recommended that all Method II CAH ambulatory services be included in the attribution methodology of the Quality Payment Program.

For Method II claims, this would involve scrubbing outpatient claims for services reported with professional revenue codes (96X, 97X and 98X) that are matched up with the applicable CPT codes. Commenters recommended an alternative, in which the Method II CAHs could be benchmarked only against themselves. Commenters indicated that the penalties would be relatively small, given that Method II CAHs bill primarily under Part A, but the publishing of these negative scores on Physician Compare will cause patients to seek care elsewhere, further destabilizing the rural delivery system.

Response: We appreciate the commenters expressing their concerns and note that MIPS eligible clinicians who practice in Method II CAHs may be eligible for the low-volume threshold exclusion, in which such eligible clinicians who do not exceed $30,000 of billed Medicare Part B allowed charges or 100 Part B-enrolled Medicare beneficiaries would be excluded from MIPS. We believe this exclusion will benefit eligible clinicians who practice in Method II CAHs. We refer readers to section II.E.10. of this final rule with comment period for final policies regarding public reporting on Physician Compare.

Comment: One commenter suggested that CMS delay the start of the MIPS program for MIPS eligible clinicians who practice in Method II CAHs and have assigned their billing rights to the CAH.

Response: We appreciate the suggestion from the commenter. However, we do not deem it necessary or justifiable to delay the participation of MIPS eligible clinicians who provide services in Method II CAHs and have assigned their billing rights to the CAH given that Method II CAHs were required to participate in PQRS and the Medicare EHR Incentive Program.

Comment: One commenter indicated that many clinicians who practice in Method II CAHs would provide their clinical care in RHCs/FQHCs, and as such, their only qualifying Part B charges would be documented in the CAH's inpatient CEHRT. The commenter noted that while PQRS was mandated for these clinicians, facilities face difficulty creating quality PQRS reports based on extremely limited encounters. The commenter also indicated that it is overly burdensome to require these low-volume “inpatient only” CAH providers to participate in the MIPS program until inpatient CEHRT software is required through the certification process to produce NQF measure reports (on a clinician by clinician basis) relevant to any and all CMS quality programs. The commenter recommended that all clinicians who practice in Method II CAHs be exempt from reporting under MIPS, similar to the provisions established under the EHR Incentive Program that exempt hospital-based EPs from the application of the meaningful use payment adjustment.

Response: We appreciate the concerns expressed by the commenter regarding MIPS eligible clinicians who practice in Method II CAHs and note that clinicians meeting the definition of a MIPS eligible clinician, unless eligible for an exclusion, are generally required to participate in MIPS (section II.E.3. of this final rule with comment period describes the provisions pertaining to the exclusions from MIPS participation). For MIPS eligible clinicians who practice in Method II CAHs and have not assigned their billing rights to the CAH, the MIPS payment adjustment would apply to payments made for items and services billed by MIPS eligible clinicians under the PFS, but it would not apply to the facility payment to the CAH itself. However, for MIPS eligible clinicians who practice in Method II CAHs and have assigned their billing rights to the CAH, the MIPS payment adjustment applies to Method II CAH payments under section 1834(g)(2)(B) of the Act.

In section II.E.5.g.(8)(a)(i) of this final rule with comment period, we noted that CAHs (and eligible hospitals) are subject to meaningful use requirements under sections 1886(b)(3)(B) and (n) and 1814(l) of the Act, respectively, which were not affected by the enactment of the MACRA. CAHs (and eligible hospitals) are required to report on objectives and measures of meaningful use under the EHR Incentive Program, as outlined in the 2015 EHR Incentive Programs final rule. The objectives and measures of the EHR Incentive Programs for CAHs (and eligible hospitals) are specific to these facilities, and are more applicable and better represent the EHR technology available in these settings. Section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the application of the payment adjustment under the EHR Incentive Program and section 1848(a)(7)(B) of the Act provides the authority to exempt an EP who is not a meaningful EHR user from the application of the payment adjustment if it is determined that compliance with the meaningful EHR user requirements would result in a significant hardship, such as in the case of an EP who practices in a rural area without sufficient internet access. The MACRA did not maintain these statutory exceptions for the advancing care information performance category under MIPS. Thus, the exceptions under sections 1848(a)(7)(B) and (D) of the Act are limited to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act and do not apply in the context of the MIPS program.

Section 1848(q)(5)(F) of the Act provides the authority to assign different scoring weights (including a weight of zero) for each performance category if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician, including hospital-based clinicians. Accordingly, as described in section II.E.5.g.(8)(a)(i) of this final rule with comment period, we may assign a weight of zero percentage for the advancing care information performance category for hospital-based MIPS eligible clinicians. Under MIPS, we define a hospital-based MIPS eligible clinician as a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the Place of Service (POS) codes 21, 22, and 23 used in the HIPAA standard transaction as an inpatient hospital, on campus outpatient hospital or emergency room setting in the year preceding the performance period. Consistent with the Start Printed Page 77051EHR Incentive Program, we will determine which MIPS eligible clinicians qualify as “hospital-based” for a MIPS payment year.

Comment: One commenter requested that CMS address data capture issues for CAHs that may be required to participate in the MIPS and examine whether there are mechanisms for better capturing information on eligible clinicians from the CMS-1450 form. Some CAHs have reported issues with capturing full information about eligible clinicians from the institutional billing form used by CAHs (UB-04/CMS-1450). Under existing billing rules, CAHs may bill one CMS-1450 per day, with claims from multiple providers are combined into one submission.

Response: We appreciate the commenter expressing these concerns and intend to address operational and system-infrastructure issues experienced under previously established CMS programs and ensure that MIPS eligible clinicians have an improved experience when participating in the MIPS program.

After consideration of the public comments we received, we are finalizing our proposal that the MIPS payment adjustment will apply to Method II CAH payments under section 1834(g)(2)(B) of the Act when MIPS eligible clinicians who practice in Method II CAHs have assigned their billing rights to the CAH.

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

As noted in section II.E.1.d. of the proposed rule (81 FR 28176), section 1848(q)(6)(E) of the Act provides that the MIPS payment adjustment is applied to the amount otherwise paid under Part B with respect to the items and services furnished by a MIPS eligible clinician during a year. Some eligible clinicians may not receive MIPS payment adjustments due to their billing methodologies. If a MIPS eligible clinician furnishes items and services in an RHC and/or FQHC and the RHC and/or FQHC bills for those items and services under the RHC's or FQHC's all-inclusive payment methodology, the MIPS adjustment would not apply to the facility payment to the RHC or FQHC itself. However, if a MIPS eligible clinician furnishes other items and services in an RHC and/or FQHC and bills for those items and services under the PFS, the MIPS adjustment would apply to payments made for items and services. We note that eligible clinicians providing services for a RHC or FQHC as an employee or contractor is paid by the RHC or FQHC, not under the PFS. When a MIPS eligible clinician furnishes professional services in an RHC and/or FQHC, the RHC bills for those services under the RHC's all-inclusive rate methodology and the FQHC bills for those services under the FQHC prospective payment system methodology, in which the MIPS payment adjustment would not apply to the RHC or FQHC payment. Therefore, we proposed that services rendered by an eligible clinician that are payable under the RHC or FQHC methodology would not be subject to the MIPS payments adjustments. However, these eligible clinicians have the option to voluntarily report on applicable measures and activities for MIPS, in which the data received would not be used to assess their performance for the purpose of the MIPS payment adjustment. We requested comments on this proposal.

The following is a summary of the comments we received regarding our proposal that services rendered by an eligible clinician that are payable under the RHC or FQHC methodology would not be subject to the MIPS payments adjustments.

Comment: Several commenters supported CMS' proposal that items and services furnished by a MIPS eligible clinician that are payable under the RHC or FQHC methodology would not be subject to the MIPS payment adjustments.

Response: We appreciate the support from commenters.

Comment: One commenter noted that it is unclear what the participation requirements are for MIPS eligible clinicians who practice in FQHCs.

Response: In this final rule with comment period, we note that items and services furnished by a MIPS eligible clinician that are payable under the RHC or FQHC methodology would not be subject to the MIPS payments adjustment. These MIPS eligible clinicians have the option to voluntarily report on applicable measures and activities for MIPS. If such MIPS eligible clinicians voluntarily participate in MIPS, they would follow the requirements established for each performance category. We note that the data received from such MIPS eligible clinicians would not be used to assess their performance for the purpose of the MIPS payment adjustment. However, items and services furnished by a MIPS eligible clinician that are billed Medicare Part B charges by the MIPS eligible clinician would be subject to the MIPS payment adjustment. Also, we note that such MIPS eligible clinicians who furnished items and services that are billed Medicare Part B allowed charges by such MIPS eligible clinicians may be excluded from the requirement to participate in MIPS if they do not exceed the low-volume threshold as described in section II.E.3.c. of this final rule with comment period.

Comment: Several commenters agreed with voluntary reporting of MIPS data for FQHC and RHC clinicians as described in the proposed rule, and recommended that quality reporting requirements should be matched with HRSA measures. Commenters noted that drawing conclusions from the initial data could be problematic based upon coding and documentation differences compared to other clinicians reporting MIPS data. One commenter requested that CMS not request FQHCs and RHCs to voluntarily submit data. The commenter indicated such organizations have neither the IT support nor administrative staff to submit extended data.

Response: We thank the commenters for expressing their concerns regarding the comparability of data submitted by MIPS eligible clinicians who practice in RHCs and FQHCs. We want to reiterate that such MIPS eligible clinicians have the option to decide whether or not they voluntarily participate in MIPS.

Comment: A few commenters requested CMS to ensure that FQHC clinicians are not subject to MIPS for the limited number of FQHC-related claims submitted under the PFS. Alternatively, one commenter requested that fee service claims for non-specialty services furnished by clinicians practicing in FQHCs or RHCs not be counted when determining eligibility for the low-volume threshold.

Response: We appreciate the concern expressed by the commenter and note that section 1848(q)(6)(E) of the Act provides that the MIPS payment adjustment is applied to the amount otherwise billed under Medicare Part B charges with respect to the items and services furnished by a MIPS eligible clinician during a year. With respect to the comment regarding the low-volume threshold, we refer readers to section II.E.3.c. of this final rule with comment period, in which we establish a low-volume threshold to identify MIPS eligible clinicians excluded from participating in MIPS. We disagree with the recommendation that the fee for service claims for non-specialty items and services furnished by clinicians practicing in FQHCs or RHCs should be excluded from the low-volume threshold eligibility determination. We believe that the low-volume threshold established in this final rule with comment period retains as MIPS eligible Start Printed Page 77052clinicians those MIPS eligible clinicians who are treating relatively few beneficiaries, but engage in resource intensive specialties, or those treating many beneficiaries with relatively low-priced services. We can meaningfully measure the performance and drive quality improvement across the broadest range of MIPS eligible clinician types and specialties. Conversely, it excludes MIPS eligible clinicians who do not have a substantial quantity of interactions with Medicare beneficiaries or furnish high cost services. Clinicians practicing in a RHC or FQHC not exceeding the low-volume threshold would be excluded from the MIPS requirements.

Comment: Several commenters indicated that RHCs should be incentivized to participate and report quality data under the Quality Payment Program. One commenter indicated that the voluntary participation option is unlikely to be used without an incentive. Another commenter recommended that CMS conduct a survey of RHCs before it makes the effort to set up a voluntary reporting program that no one is likely to use. The commenter's own survey found that without incentives or penalties, very few RHCs would voluntarily participate in MIPS, and found that an incentive payment of $10,000 per clinic per year would prompt about half of RHCs to report under MIPS. A few commenters suggested that CMS include RHCs in MIPS, as these are the only primary care system left in the country with no tie to value.

Response: We appreciate the suggestions from commenters and will consider them as we assess the volume of voluntary reporting under MIPS.

Comment: One commenter expressed concern that under CMS' proposal to exclude RHCs from MIPS, RHCs' patients will fail to benefit from the rigorous quality measurement that comparable practices under MIPS program will experience. The commenter is concerned about the growing disparities in quality and life expectancy between rural and urban patients. The commenter notes that the number of RHCs has grown from 400 in 1990 to more than 4,000 today, with new conversions continuing as more rural providers realize they can get paid more than FFS under this model.

Response: We thank the commenter for expressing concerns and note that MIPS eligible clinicians who practice in RHCs and furnish items and services that are payable under the RHC methodology have the option to voluntarily report on applicable measures and activities for MIPS.

Comment: A few commenters requested that consideration be given to phase-in requests for FQHC voluntary reporting to allow for the development of social determinants of health status measure adjustments.

Response: We appreciate the feedback on the role of socioeconomic status in quality measurement. We continue to evaluate the potential impact of social risk factors on measure performance. One of our core objectives is to improve beneficiary outcomes, and we want to ensure that complex patients as well as those with social risk factors receive excellent care.

Comment: A few commenters supported CMS' proposal to be inclusive of rural practices, but encouraged CMS to have special conditions for such rural clinicians that have not participated in PQRS, VM, or the Medicare EHR Incentive Program for EPs in the past and suggested a phased approach for full participation that protects safety net clinicians from downside risk.

Response: We appreciate the support from commenters and note that MIPS eligible clinicians who practice in RHCs and furnish items and services that are payable under the RHC methodology would not be subject to the MIPS payments adjustments for such items and services, but would have the option to voluntarily report on applicable measures and activities for MIPS. For such MIPS eligible clinicians who voluntarily participate in MIPS, the data submitted to CMS would not be used to assess their performance for the purpose of the MIPS payment adjustment.

Comment: One commenter recommended that CMS create a system permitting the voluntary reporting of performance information by excluded clinicians, and that the data reported be used to help define rural-specific measures and standards for these clinicians and for all rural clinicians. Under this system, data would be released only on an aggregate basis, protecting the privacy of individual entities reporting.

Response: We thank the commenter for the suggestions and will consider them as we establish policies pertaining to MIPS eligible clinicians who practice in RHCs and FQHCs in future rulemaking.

Comment: One commenter noted that in certain communities, clinical services are delivered in RHCs, small independent practices and community health centers, in which hospital-based services billed under the PFS may only represent a small portion of total care provided. The commenter requested that CMS develop a method for rural clinicians such as those practicing in RHCs and FQHCs to have a meaningful avenue to participate in the Quality Payment Program. Another commenter indicated that RHCs, CAHs, and FQHCs were created to assure the availability of health care services to remote and underserved populations, and while a majority of clinicians who practice in RHCs, CAHs, and FQHCs bill under Medicare Part A, may have a limited number of encounters for which services are billed under Medicare Part B. Thus, such clinicians may exceed the low-volume threshold and therefore be subject to the MIPS payment adjustment. The commenter expressed concerns that RHCs, CAHs, and FQHCs would be negatively impacted by having their resources stretched even further if required to meet the requirements under MIPS or be subject to a negative MIPS payment adjustment. The commenter also noted that many RHCs and FQHCs have not implemented EHR technology due to the lack of available resources and struggle to recruit qualified clinicians and staff, and as a result, such clinicians and staff are disproportionately older than the average health care workforce. If RHCs and FQHCs are required to participate in MIPS and meet all requirements or be subject to a negative MIPS payment adjustment, the fiscal resources reduced by either a MIPS payment adjustment or investment in EHR technology would significantly impact and reduce the availability of services available to remote and underserved populations. The commenter recommended that CMS consider permanent exclusions for clinicians practicing in RHCs and FQHCs from the requirement to participate in the MIPS program. One commenter noted that CMS should provide exemptions from entire performance categories, not just individual measures and activities, consider the feasibility of shorter reporting timeframes, and ensure that there are free or low cost reporting options within each MIPS performance category.

Response: We appreciate the commenters expressing their concerns and providing recommendations. We will take into consideration the suggestions from commenters in future rulemaking. We note that the MIPS payment adjustment is limited to items and services furnished by MIPS eligible clinicians for billed Medicare Part B charges such as those under the PFS. We note that MIPS eligible clinicians practicing in RHCs and FQHCs will benefit from other policies that we are finalizing throughout this final rule with Start Printed Page 77053comment period such as the higher low-volume threshold, lower reporting requirements, and lower performance threshold.

Comment: One commenter requested clarification on how CMS would define rural areas and suggested that CMS adopt a consistent definition for the term “small practices” across all CMS programs. The commenter suggested that a small practice be defined as having 25 or fewer clinicians. Another commenter recommended that the low-volume threshold be set at an even higher level for rural and underserved areas to ensure that MIPS does not endanger the financial stability of rural safety net practices or reduce access to services for rural Medicare beneficiaries.

Response: We note that we define rural areas as clinicians in zip codes designated as rural, using the most recent HRSA Area Health Resource File data set available as described in section II.E.5.f.(5) of this final rule with comment period. Also, in section II.E.5.f.(5) of this final rule with comment period, we define small practices as practices consisting of 15 or fewer clinicians. We are finalizing our proposed definition of small practices because the statute provides special considerations for small practices consisting of 15 or fewer clinicians. In regard to the commenter's suggestion pertaining to the low-volume threshold, we are finalizing a modification to our proposal, which establishes a higher low-volume threshold as described in section II.E.3.c. of this final rule with comment period.

Comment: Some commenters recommended that CMS follow the recommendations of the NQF Report on Performance Measurement for Rural Low-Volume Providers and establish rural peer groups and rural-specific standards for assessment of rural provider performance in all domains. Commenters noted that the NQF developed specific recommendations for how pay-for-performance mechanisms should be implemented for rural providers. The NQF Report on Performance Measurement for Rural Low-Volume Providers sets out both overarching and specific approaches for how rural provider performance measurement should be handled. The NQF Report on Performance Measurement for Rural Low-Volume Providers also makes recommendations about rural performance measures of domains other than quality, including cost. One commenter noted that as rural-specific quality measures are developed, such measures should be both mandatory core measures and elective supplementary measures.

Response: We appreciate the recommendations provided by the commenters and will take them into consideration for future rulemaking.

Comment: One commenter agreed with the goals of the proposed rule, but believed that the proposed rule had one thematic deficiency as a result of the quality reporting constructs, which implied a dichotomy of “primary care” versus “specialist” with the correlate implication that all specialists and specialties impact value of current health care similarly (and generally adversely) and marginalized specialties as leaders in care quality and efficiency improvement. The commenter recommended that CMS create specialty-specific quality and efficiency targets that incentivize specialists caring for high risk, high-cost chronically ill patients to provide the best long-term care and coordinate care with primary care physicians (including chronic care subspecialists practicing across multiple health systems rather than as part of a larger provider entity) with each specialty having specific quality goals and efficiency targets.

Response: We appreciate the feedback from the commenter, but disagree with commenter's assessment that our policies marginalize specialists. We will take into consideration the recommendations provided by the commenter for future rulemaking.

Comment: Due to complexity of the proposed rule and the extremely short projected turnaround time before the start of the 2017 performance period, a few commenters recommended that Frontier Health Professional Shortage Area (HPSA) clinicians should be exempt from mandatory MIPS/APM participation until 2019, when the program has had a chance to evaluate its successes and failures with respect to larger, more economically stable participants. The commenters suggested that Frontier HPSA clinicians should be allowed to voluntarily participate if they want to, but they should not be penalized due to the low-income, low-population challenges faced in extremely rural areas until payment year 2021 or later.

Response: We note that the statute does not grant the Secretary discretion to establish exclusions other than the three exclusions described in section II.E.3. of this final rule with comment period. Thus, Frontier HPSA clinicians who are MIPS eligible clinicians are required to participate in MIPS. However, we believe that Frontier HPSA clinicians will benefit from other policies that we are finalizing throughout this final rule with comment period such as the higher low-volume threshold, lower reporting requirements, and lower performance threshold.

After consideration of the public comments we received, we are finalizing our proposal that services rendered by an eligible clinician under the RHC or FQHC methodology, will not be subject to the MIPS payments adjustments. However, these eligible clinicians have the option to voluntarily report on applicable measures and activities for MIPS, in which the data received will not be used to assess their performance for the purpose of the MIPS payment adjustment.

e. Group Practice (Group)

Section 1848(q)(1)(D) of the Act, requires the Secretary to establish and apply a process that includes features of the PQRS group practice reporting option (GPRO) established under section 1848(m)(3)(C) of the Act for MIPS eligible clinicians in a group for purposes of assessing performance in the quality performance category. In addition, it gives the Secretary the discretion to do so for the other three performance categories. Additionally, we will assess performance either for individual MIPS eligible clinicians or for groups. As discussed in section II.E.2.b. of the proposed rule (81 FR 28177), we proposed to define a group at § 414.1305 as a single Taxpayer Identification Number (TIN) with two or more MIPS eligible clinicians, as identified by their individual National Provider Identifier (NPI), who have reassigned their Medicare billing rights to the TIN. Also, as outlined in section II.E.2.c. of the proposed rule (81 FR 28177), we proposed to define an APM Entity group at § 414.1305 identified by a unique APM participant identifier. However, we are finalizing a modification to the definition of a group as described in section II.E.2.b. of this final rule with comment period and finalizing the definition of an APM Entity group as described in section II.E.2.c. of this final rule with comment period.

2. MIPS Eligible Clinician Identifier

To support MIPS eligible clinicians reporting to a single comprehensive and cohesive MIPS program, we need to align the technical reporting requirements from PQRS, VM, and EHR-MU into one program. This requires an appropriate MIPS eligible clinician identifier. We currently use a variety of identifiers to assess an individual eligible clinician or group under different programs. For example, under the PQRS for individual reporting, CMS uses a combination of TIN and NPI to assess eligibility and Start Printed Page 77054participation, where each unique TIN and NPI combination is treated as a distinct eligible clinician and is separately assessed for purposes of the program. Under the PQRS GPRO, eligibility and participation are assessed at the TIN level. Under the Medicare EHR Incentive Program, we utilize the NPI to assess eligibility and participation. And under the VM, performance and payment adjustments are assessed at the TIN level. Additionally, for APMs such as the Pioneer Accountable Care Organization (ACO) Model, we also assign a program-specific identifier (in the case of the Pioneer ACO Model, an ACO ID) to the organization(s), and associate that identifier with individual eligible clinicians who are, in turn, identified through a combination of a TIN and an NPI.

In the MIPS and APMs RFI (80 FR 63484), we sought comments on which specific identifier(s) should be used to identify a MIPS eligible clinician for purposes of determining eligibility, participation, and performance under the MIPS performance categories. In addition, we requested comments pertaining to what safeguards should be in place to ensure that MIPS eligible clinicians do not switch identifiers to avoid being considered “poor-performing” and comments on what safeguards should be in place to address any unintended consequences, if the MIPS eligible clinician identifier were a unique TIN/NPI combination, to ensure an appropriate assessment of the MIPS eligible clinician's performance. In the MIPS and APMs RFI (80 FR 63484), we sought comment on using a MIPS eligible clinician's TIN, NPI, or TIN/NPI combination as potential MIPS eligible clinician identifiers, or creating a unique MIPS eligible clinician identifier. The commenters did not demonstrate a consensus on a single best identifier.

Commenters favoring the use of the MIPS eligible clinician's TIN recommended that MIPS eligible clinicians should be associated with the TIN used for receiving payment from CMS claims. They further commented that this approach will deter MIPS eligible clinicians from “gaming” the system by switching to a higher performing group. Under this approach, commenters suggested that MIPS eligible clinicians who bill under more than one TIN can be assigned the performance and MIPS payment adjustment for the primary practice based upon majority of dollar amount of claims or encounters from the prior year.

Other commenters supported using unique TIN and NPI combinations to identify MIPS eligible clinicians. Commenters suggested many eligible clinicians are familiar with using TIN and NPI together from PQRS and other CMS programs. Commenters also noted this approach can calculate performance for multiple unique TIN/NPI combinations for those MIPS eligible clinicians who practice under more than one TIN. Commenters who supported the TIN/NPI also believed this approach enables greater accountability for individual MIPS eligible clinicians beyond what might be achieved when using TIN as an identifier and would provide a safeguard from MIPS eligible clinicians changing their identifier to avoid payment penalties.

Some commenters supported the use of only the NPI as the MIPS identifier. They believed this approach would best provide for individual accountability for quality in MIPS while minimizing potential confusion because providers do not generally change their NPI over time. Supporters of using the NPI only as the MIPS identifier also commented that this approach would be simplest for administrative purposes. These commenters also note the continuity inherent with the NPI would address the safeguard issue of providers attempting to change their identifier for MIPS performance purposes.

In the MIPS and APMs RFI (80 FR 63484), we also solicited feedback on the potential for creating a new MIPS identifier for the purposes of identifying MIPS eligible clinicians within the MIPS program. In response, many commenters indicated they would not support a new MIPS identifier. Commenters generally expressed concern that a new identifier for MIPS would only add to administrative burden, create confusion for MIPS eligible clinicians and increase reporting errors.

After reviewing the comments, we did not propose to create a new MIPS eligible clinician identifier. However, we appreciated the various ways a MIPS eligible clinician may engage with MIPS, either individually or through a group. Therefore, we proposed to use multiple identifiers that allow MIPS eligible clinicians to be measured as an individual or collectively through a group's performance. We also proposed that the same identifier be used for all four performance categories; for example, if a group is submitting information collectively, then it must be measured collectively for all four MIPS performance categories: Quality, cost, improvement activities, and advancing care information. As discussed in the final score methodology section II.E.6. of the proposed rule (81 FR 28247 through 28248), we proposed to use a single identifier, TIN/NPI, for applying the MIPS payment adjustment, regardless of how the MIPS eligible clinician is assessed. Specifically, if the MIPS eligible clinician is identified for performance only using the TIN, we proposed to use the TIN/NPI when applying the MIPS payment adjustment. We requested comments on these proposals.

The following is a summary of the comments we received regarding our proposals to use multiple identifiers that allow MIPS eligible clinicians to be measured as an individual or collectively through a group's performance and use a single identifier, TIN/NPI, for applying the MIPS payment adjustment.

Comment: Several commenters supported the proposal to have each unique TIN/NPI combination considered a different MIPS eligible clinician and to use the TIN to identify group practices. One commenter noted that using a group's billing TIN to identify a group is consistent with the current CMS approach under PQRS and VM, and is preferable to creating a new MIPS-specific identifier for groups.

Response: We appreciate the support from commenters.

Comment: One commenter noted that the proposed MIPS identifiers (combination of TIN/NPI, etc.) would be sufficient for individual, group, and APM reporting to MIPS, but requested that CMS establish an identifier for virtual groups. Another commenter questioned the use of these identifiers beyond their original purposes.

Response: We appreciate the feedback from the commenters. We did not propose an identifier for virtual groups, but in future rulemaking, we will take into consideration the establishment of a virtual group identifier. As noted in this final rule with comment period, the use of the identifiers enables us to identify individual MIPS eligible clinicians at the TIN/NPI level and groups at the TIN level.

Comment: A few commenters opposed the approach of creating a new MIPS eligible clinician identifier at the initiation of the Quality Payment Program because it would be premature and cause confusion. The commenter further noted that there may be times when a clinician is not MIPS eligible and then becomes MIPS eligible. Also, the commenter indicated that there is currently not a way to report the identifier on claims.

Response: We disagree with the commenter and believe that it is Start Printed Page 77055essential for us to be able to identify individual MIPS eligible clinicians using a unique identifier because the MIPS payment adjustment would be applied to the Medicare Part B charges billed by individual MIPS eligible clinicians at the TIN/NPI level. We note that we will be able to identify, at the NPI level, individual eligible clinicians who are excluded from the MIPS requirements and not subject to the MIPS payment adjustment for exclusions pertaining to new Medicare-enrolled eligible clinicians and QPs and Partial QPs not participating MIPS. In our analyses of claims data, we will be able to identify individual MIPS eligible clinicians at the TIN/NPI level given that billing is associated with a TIN or TIN/NPI.

Comment: One commenter recommended the use of TINs plus alphanumeric codes as identifiers.

Response: We disagree with the commenter's suggestion to use a TIN with an alphanumeric code because it would add complexity and not facilitate the identification of individual eligible clinicians at the NPI level who are associated with a group at the TIN level. For certain exclusions (for example, new Medicare-enrolled eligible clinicians, and QPs and Partial QPs who are not participating in MIPS), eligibility determinations will be made and applied at the NPI level.

Comment: Several commenters requested that small physician practices be exempt from MIPS. A few commenters indicated that penalizing small practices would decrease access to care for patients. One commenter indicated that small groups and independent physicians are unfairly penalized and are being forced to integrate into larger hospital or corporations. Another commenter expressed concern that additional administrative duties will affect patient care and will not improve healthcare. One commenter indicated that the proposed rule was discriminatory toward solo or small group practices. The commenter noted that the financial burden of MACRA will result in the closure of many solo and small group practitioners.

Response: We appreciate the concerns expressed by the commenters. We note that the statute does not grant the Secretary with discretion to establish exclusions other than the exclusions described in section II.E.3. of this final rule with comment period. However, we believe that small practices will benefit from policies we are finalizing throughout this final rule with comment period such as the higher low-volume threshold, lower performance requirements, and lower performance threshold.

Comment: A few commenters requested that CMS determine and state eligibility status for clinicians providing services at independent diagnostic testing facilities (IDTFs) and to provide clear, detailed guidance under what circumstances eligibility would occur under MIPS. The commenter noted that CMS has issued similar guidance under the PQRS system of “eligible but not able to participate”; however, the commenter indicated that the guidance provided in PQRS does not address all variations of billing and coding practices of IDTFs.

Response: We note that the MIPS payment adjustment applies only to the amount otherwise paid under Part B with respect to items and services furnished by a MIPS eligible clinician during a year. As discussed in section II.E.7. of this final rule with comment period, we will apply the MIPS adjustment at the TIN/NPI level. In regard to suppliers of independent diagnostic testing facility services, we note that such suppliers are not themselves included in the definition of a MIPS eligible clinician. However, there may be circumstances in which a MIPS eligible clinician would furnish the professional component of a Part B covered service that is billed by such a supplier. Those services could be subject to MIPS adjustment based on the MIPS eligible clinician's performance during the applicable performance period. Because, however, those services are billed by suppliers that are not MIPS eligible clinicians, it is not operationally feasible for us at this time to associate those billed allowed charges with a MIPS eligible clinician at an NPI level in order to include them for purposes of applying any MIPS payment adjustment.

Comment: One commenter expressed concern regarding the definition of a group (unique TIN) because large health systems and hospitals operate large medical groups spanning practices and specialties, and all of them share a TIN and EHRs. The commenter indicated that grouping all clinicians together takes away the advantages of group participation. The commenter noted that CMS should generate another way for group practices to differentiate themselves.

Response: We thank the commenter for expressing their concern. We disagree with the commenter because we believe that group level reporting is advantageous for groups in that it encourages coordination, teamwork, and shared responsibility. However, we recognize that we are not able to identify groups with eligible clinicians who are excluded from the MIPS requirements both at the individual level and group level such as new Medicare-enrolled clinicians. We note that we could establish new identifiers to more accurately identify such eligible clinicians. For future consideration, we are seeking additional comment on the identifiers. What are the advantages and disadvantages of identifying new Medicare-enrolled eligible clinicians and eligible clinicians not included in the definition of a MIPS eligible clinician until year 3 such as therapists? What are the possible identifiers that could be established for identifying such eligible clinicians?

Comment: One commenter requested clarification about how CMS intends to treat group practices participating in MIPS in regard to satisfying the “hospital-based clinician” definition, and questioned if it would evaluate the group as a whole, or each individual within the group. And if the latter, the commenter questioned if CMS would adopt a process for scoring individuals in a group differently than the overall group. Another commenter requested that CMS consider how the definition of a group, and use of a single TIN, could represent facility-based outpatient therapy clinicians. Currently, many facility-based outpatient clinicians operate under the facility's TIN.

Response: We note that hospital-based MIPS eligible clinicians are considered MIPS eligible clinicians are required to participate in MIPS. However, section II.E.5.g.(8)(a)(i) of this final rule with comment period describes our final policies regarding the re-weighting of the advancing care information performance category within the final score, in which we would assign a weight of zero when there are not sufficient measures applicable and available for hospital-based MIPS eligible clinicians.

In regard to how the definition of a group corresponds facility-based outpatient clinicians, we noted that the MIPS payment adjustment applies only to the amount otherwise paid under Part B with respect to items and services furnished by a MIPS eligible clinician during a year, in which we will apply the MIPS adjustment at the TIN/NPI level (see section II.E.7. of this final rule with comment period). For items and services furnished by such clinicians practicing in a facility that are billed by the facility, such items and services may be subject to MIPS adjustment based on the MIPS eligible clinician's performance during the applicable performance period. For those billed Medicare Part B allowed charges we are Start Printed Page 77056able to associate with a MIPS eligible clinician at an NPI level, such items and services furnished by such clinicians would be included for purposes of applying any MIPS payment adjustment.

Comment: Several commenters recommended that CMS extend groups to include multiple TINs and require that those TINs share and have access to the same EHR. Commenters noted that group reporting would be complicated by clinicians joining the group, and clinicians assigned to multiple TINs using different EHR systems. The commenters also expressed concern about the ability for groups to submit quality data under the group reporting option using different types of EHRs. Commenter requested the submission of multiple specialty specific data sets and to alter the scoring methodology.

Response: We appreciate the commenters expressing their concerns and providing their suggestions. We are finalizing the definition of a group as proposed. We disagree with commenters that the definition of a group should be modified in order to account for operational and technical data mapping issues. We believe that the finalized definition of a group provides groups with the opportunity to utilize its performance data in ways that can improve coordination, teamwork, and shared responsibility.

We do not believe that the definition of a group would create complications for eligible clinicians associated with multiple TINs. We note that individual eligible clinicians would be required to meet the MIPS requirements for each TIN/NPI association unless they are excluded from MIPS based on an exclusion established in section II.E.3. of this final rule with comment period.

Comment: One commenter requested CMS to ensure that each service provided to a patient is associated with the actual clinician furnishing that service.

Response: We note that the MIPS payment adjustment for individual MIPS eligible clinicians is applied to the Medicare Part B payments for items and services furnished by each MIPS eligible clinician. For groups reporting at the group level, scoring and the application of the MIPS payment adjustment is applied at the TIN level for Medicare Part B payments for items and services furnished by the eligible clinicians of the group.

Comment: One commenter supported CMS' proposal for optional group performance tracking and submission, but recommended that CMS provide additional guidelines for clinicians who practice under multiple identifiers. The commenter requested additional clarification on how MIPS payment adjustments would impact clinicians working under multiple identifiers at multiple organizations.

Response: We appreciate the support from the commenter. As previously noted, individual eligible clinicians who are part of several groups and thus, associated with multiple TINs, such individual eligible clinicians would be required to participate in MIPS for each group (TIN) association unless the eligible clinician (NPI) is excluded from the MIPS. Section II.E.3.e. of this final rule with comment period describes how the exclusion policies relate to groups with eligible clinicians excluded from MIPS.

Comment: With many clinicians practicing within multiple TINs, one commenter suggested that even though it is unclear how multiple-TIN clinicians who choose individual reporting would be scored, CMS should use the clinician's highest TIN performance score for each of the four performance categories. Another commenter requested clarification on how the Quality Payment Program rule will apply to clinicians who work under multiple TINs, including the scenario where one TIN is participating in an ACO and another is not.

Response: We note that groups have to the option to report at the individual or group level. For individual eligible clinicians associated with multiple TINs, the individual eligible clinician will either report at the individual level if the group elects to report at the individual or be included in the group-level reporting if the group elects group-level reporting. As previously noted, individual eligible clinicians who are associated with multiple TINs would be required to participate in MIPS for each group (TIN) association unless the eligible clinician (NPI) is excluded from the MIPS.

Comment: One commenter noted as a reminder to CMS that using TINs as identifiers has caused some problems in the past such as the accuracy of TINs. When TINs are not accurate, performance rates and program metrics may be incorrect. The commenter recommended that CMS establish clear and efficient mechanisms for groups to resolve inconsistencies.

Response: We appreciate the feedback from the commenter and will take into consideration the commenter's suggestions in future rulemaking.

Comment: Several commenters supported the proposal to permit clinicians to report either at the individual or group level. However, one commenter expressed concern about limitations on the ability of clinicians, in the context of group-level reporting, to report the most appropriate and meaningful specialty measures. Another commenter indicated that it was not clear how group reporting would allow for specialty specific reporting, given the lack of a TIN for individual departments within a larger faculty practice plan or physician group. The commenter noted that this could cause thousands of providers to miss out on the best use of MIPS because their facilities chose reporting measures and activities that would not reflect the care they individually provide. Therefore, the commenter suggested that CMS create a reporting option within MIPS that would allow specialty-specific groups to self-designate as “group” under MIPS even if they were part of the TIN for a larger facility practice plan or physician group. The commenter noted that this would facilitate the comparison of physicians providing a similar mix of procedures for comparison for the purpose of assigning a final score. Another commenter recommended that CMS consider the common business model where large hospitals and health systems acquire multiple physician practices.

Response: We appreciate the support from the commenters. We will consider the recommendations from the commenters in future rulemaking. We note that group-level reporting does not provide the option for groups to report at sub-levels of the group by specialty. We believe that group-level reporting ensures coordination, teamwork, and shared responsibility.

Comment: A few commenters expressed concern regarding MIPS eligible clinicians moving practices in the middle of a reporting period. One commenter recommended that if a clinician changes TINs during the course of a year, their final composite score should be attributed to their final TIN on December 31 of that year. Another commenter indicated that by using a TIN/NPI combination, CMS could accurately match reporting data to an individual clinician because often the NPI of the clinician will not change, and CMS could match the new TIN to ensure accurate attribution.

Response: We appreciate the concerns and suggestions from the commenters and note that individual MIPS eligible clinicians may be associated with more than one TIN during the performance period due to a variety of reasons with differing timeframes. In sections II.E.6. and II.E.7. of this final rule with comment period, we describe how individual MIPS eligible will have their performance assessed and scored and Start Printed Page 77057how the MIPS payment adjustment would be applied if a MIPS eligible clinician changes TINs during the performance period.

Comment: One commenter expressed concern regarding how group size would be calculated, particularly how clinicians that are not subject to MIPS would be included in the size of the group.

Response: CMS does not make an eligibility determination regarding a group size. We note that groups attest to their group size for purpose of using the CMS Web Interface or a group identifying as a small practice. In order for groups to determine their group size, we note that a group size would be determined before exclusions are applied.

Comment: One commenter recommended that CMS allow validation or updating of clinicians' identifying information in the PECOS system, and not a separate system.

Response: We appreciate the suggestion from the commenter and will consider it as we operationalize the use of PECOS for MIPS.

After consideration of the public comments we received, we are finalizing the use of multiple identifiers that allow MIPS eligible clinicians to be measured as an individual or collectively through a group's performance. Additionally, we are finalizing our proposal that the same identifier be used for all four performance categories. For example, if a group is submitting information collectively, then it must be measured collectively for all four MIPS performance categories: Quality, cost, improvement activities, and advancing care information. While we have multiple identifiers for participation and performance, we are finalizing the use of a single identifier, TIN/NPI, for applying the MIPS payment adjustment, regardless of how the MIPS eligible clinician is assessed (see final score methodology outlined in section II.E.6. of this final rule with comment period). Specifically, if the MIPS eligible clinician is identified for performance only using the TIN, we will use the TIN/NPI when applying the MIPS payment adjustment.

a. Individual Identifiers

We proposed to use a combination of billing TIN/NPI as the identifier to assess performance of an individual MIPS eligible clinician. Similar to PQRS, each unique TIN/NPI combination would be considered a different MIPS eligible clinician, and MIPS performance would be assessed separately for each TIN under which an individual bills. While we considered using the NPI only, we believe TIN/NPI is a better approach for MIPS. Both TIN and NPI are needed for payment purposes and using a combination of billing TIN/NPI as the MIPS eligible clinician identifier allows us to match MIPS performance and MIPS payment adjustments with the appropriate practice, particularly for MIPS eligible clinicians that bill under more than one TIN. In addition, using TIN/NPI also provides the flexibility to allow individual MIPS eligible clinician and group reporting, as the proposed group identifiers also include TIN as part of the identifier. We recognize that TIN/NPI is not a static identifier and can change if an individual MIPS eligible clinician changes practices and/or if a group merges with another between the performance period and payment adjustment period. Section II.E.7.a. of the proposed rule describes in more detail how we proposed to match performance in cases where the TIN/NPI changes. We requested comments on this proposal.

The following is a summary of the comments we received regarding our proposal to use a combination of billing TIN/NPI as the identifier to assess performance of an individual MIPS eligible clinician.

Comment: One commenter expressed concern that independent physicians would not fare well as a result of the proposed rule.

Response: We appreciate the concern expressed by the commenter. We believe that independent clinicians will benefit from policies we are finalizing throughout this final rule with comment period such as the higher low-volume threshold, lower performance requirements, and lower performance threshold.

Comment: One commenter found the MIPS terminology confusing and believed that tracking individual clinicians for reimbursement, as outlined in the proposed rule, would be difficult.

Response: We appreciate the feedback from the commenter and will consider the ways we can explain the MIPS requirements to ensure that information is clear, understandable, and consistent.

Comment: Several commenters requested clarification regarding how individual MIPS eligible clinicians who bill to multiple TINs would have their performance assessed. Commenters questioned if they are eligible for MIPS payment adjustment under multiple TINs, if they are expected to perform under all four categories for each TIN where they practice, and how a Partial QP and individual in a group practice would be assessed for purposes of the 2019 MIPS payment adjustment based on the TIN/NPI combination.

Response: For MIPS eligible clinicians associated with multiple TINs, we note that MIPS eligible clinicians will need to meet the MIPS requirements for each TIN they are associated with unless they are excluded from the MIPS requirements based on one of the three exclusions (as described in section II.E.3. of this final rule with comment period) at the individual and/or group level.

Comment: One commenter questioned the benefit to clinicians reporting at the TIN/NPI level compared to the NPI level.

Response: We note that groups have the option to report at the individual (TIN/NPI) level or the group (TIN) level. Depending on the composition of groups, groups may find that reporting at the individual level may be more advantageous for the group than the reporting at the group level and vice versa. Individual eligible clinicians who are not part of a group, would report at the individual level.

Comment: To facilitate individual clinician-level information, one commenter recommended that CMS use the NPI identifier throughout the MIPS program. The commenter noted that the NPI is also used by the private sector, promoting greater alignment than would a newly created MIPS clinician identifier.

Response: We appreciate the suggestion from the commenter, but disagree with the commenter that we should establish an identifier only at the NPI level because we need to be able to not only account for individual NPIs, but we need to have a capacity that allows us to identify eligible clinicians and MIPS eligible clinicians who are associated with a group given that group level reporting is an option and scoring and MIPS payment adjustments would need be applied accordingly. As a result, we are finalizing the individual MIPS eligible clinician identifier using the TIN/NPI combination.

Comment: One commenter requested clarification on how clinicians using only a TIN will be scored, and then have their payment adjusted based on the TIN/NPI.

Response: We note that groups reporting at the group level will be assessed and scored, at the TIN level and have a MIPS payment adjustment applied at the TIN/NPI level. We note that the MIPS payment adjustment is applied to the MIPS eligible clinicians within the TIN for billed Medicare Part B charges.Start Printed Page 77058

After consideration of the public comments we received, we are finalizing our proposed definition of a MIPS eligible clinician at § 414.1305 to use a combination of unique billing TIN and NPI combination as the identifier to assess performance of an individual MIPS eligible clinician. Each unique TIN/NPI combination will be considered a different MIPS eligible clinician, and MIPS performance will be assessed separately for each TIN under which an individual bills. We recognize that TIN/NPI is not a static identifier and can change if an individual MIPS eligible clinician changes practices and/or if a group merges with another between the performance period and payment adjustment period. We refer readers to section II.E.7.a. of this final rule with comment period, which describes our final policy for matching performance in cases where the TIN/NPI changes.

b. Group Identifiers for Performance

We proposed the following way a MIPS eligible clinician may have their performance assessed as part of a group under MIPS. We proposed to use a group's billing TIN to identify a group. This approach has been used as a group identifier for both PQRS and VM. The use of the TIN would significantly reduce the participation burden that could be experienced by large groups. Additionally, the utilization of the TIN benefits large and small practices by allowing such entities to submit performance data one time for their group and develop systems to improve performance. Groups that report on quality performance measures through certain data submission methods must register to participate in MIPS as described in section II.E.5.b. of the proposed rule.

We proposed to codify the definition of a group at § 414.1305 as a group that would consist of a single TIN with two or more MIPS eligible clinicians (as identified by their individual NPI) who have reassigned their billing rights to the TIN. We requested comments on this proposal.

The following is a summary of the comments we received regarding our proposal establishing the way a MIPS eligible clinician may have their performance assessed as part of a group under MIPS.

Comment: Several commenters expressed concern regarding the group identifier. Commenters indicated that a group identifier restricts group reporting to TIN-level identification because TINs may represent many different specialties and subspecialists that have elected to join together for non-practice related reasons, such as billing purposes. Commenters recommended that CMS allow TINs to subdivide into smaller groups for the purposes of participating in MIPS. A few commenters recommended that CMS expand the definition of a group to include subsets in a TIN so that groups of specialists or sub-specialists within a TIN can be allowed to group accordingly. One commenter suggested expanding the allowable group identifiers for physician groups to include a group's sub-tax identification numbers based on the Medicare PFS area or the hospital payment area in which they provide care. A few commenters encouraged CMS to consider providing additional flexibility to allow clinicians to submit group rosters of TIN/NPI combinations to CMS to define a MIPS reporting group. The commenters noted that this approach would allow a large, multispecialty group under one TIN to split into clinically-relevant reporting groups, or multiple TINs within a delivery system to group report under a common group. In addition to the options that CMS proposed regarding use of multiple identifiers to assess physician/group performance under MIPS, one commenter recommended that CMS permit groups to “split” TINs for this purpose. Another commenter noted that such flexibility would be a very useful precursor to future APM participation.

Response: We appreciate the commenters expressing their concerns and providing recommendations. We recognize that groups have varying compositions of eligible clinicians and will consider the suggestions from commenters in future rulemaking. We disagree with commenters regarding their suggested approach for defining a group because multiple sublevel identifiers create more complexity given that it would require the establishment of numerous identifiers in order to account for all types of group compositions. We note that except for groups that contain APM participants, we are not permitting groups to “split” TINs if they choose to participate in MIPS as a group. We believe it is critical to establish the definition of a group that ensures coordination, teamwork, and shared responsibility at the group level, in which our proposed definition achieves this objective. We note that groups have the opportunity to analyze its data in ways that are meaningful to the group, which may include analyses for each segment of a group to promote and enhance the coordination of care and improve the quality of care and health outcomes.

Comment: Several commenters supported the proposed approach to reduce the participation burden by allowing large groups to report as a group. One commenter requested clarification on how a group's performance and final score would be applied to all NPIs in the TIN, particularly whether CMS would assess each individual across the four performance categories and then cumulatively calculate the final score or whether CMS would assess a group-based collective set of objectives that could be met by any combination of individual clinicians inside the group to calculate the final score.

Response: In section II.E.3.d. of this final rule with comment period, we note that groups reporting at the group level (TIN) must meet the definition of a group at all times during the performance period for the MIPS payment year. In order for groups to have their performance assessed as a group across all performance categories, individual eligible clinicians and MIPS eligible clinicians within a group must aggregate their performance data across the TIN.

Comment: One commenter indicated that the scoring methodology for large TINs is ambiguous.

Response: We note that the scoring methodology for groups, regardless of size, is the same as described in section II.E.6. of this final rule with comment period.

Comment: One commenter requested further clarification of attribution of eligible activities (for example, improvement activities) for one organization with one TIN that participates in MIPS and multiple APMs.

Response: For those TINs that have MIPS eligible clinicians that are subject to the APM scoring standard, we refer readers to section II.E.5.h. of this final rule with comment period for our discussion regarding policies pertaining to the APM scoring standard.

Comment: Several commenters agreed with our proposal to not require an additional identifier for qualified clinicians and instead use a combination of MIPS eligible clinician NPI and group billing TIN. To ease the administrative burden, commenters recommended the following: have attribution of a qualified clinician to a group's billing TIN be done automatically by CMS based on billing PECOS data; do not require individual third party rights for qualified clinicians, but instead let program administrators at each health system register for their groups and automatically have access to qualified Start Printed Page 77059clinicians associated with that TIN; and provide for the ability to look up statuses, eligibility, program history and other information by both individual NPI and group TIN.

Response: We appreciate the recommendations from the commenters and will consider them as we establish subregulatory guidance regarding the voluntary registration process for groups and the registration process for groups electing to use the CMS Web Interface data submission mechanism and/or administer the CAHPS for MIPS survey.

Comment: Several commenters requested that CMS consistently define “small” practices and consider additional accommodations for such practices. Commenter noted that the proposal may overburden smaller groups. There were a few commenters indicating that solo or small practices with less than 25 clinicians should be exempt from MIPS while other commenters recommended that group practices of 15 or fewer clinicians be exempt from MIPS. One commenter suggested that CMS review opportunities to provide incentives targeted around quality metrics reflective of the patient population served.

Response: We note that a small practice is defined as a practice consisting of 15 or fewer eligible clinicians. We note that the statute does not provide the discretion to establish exclusions other than the exclusions pertaining to new Medicare-enrolled eligible clinicians, QPs and Partial QPs who do not participate in MIPS, and eligible clinicians who do not exceed the low-volume threshold. However, small groups may be excluded from MIPS if they do not exceed the low-volume threshold as established in section II.E.3.c. of this final rule with comment period.

Comment: One commenter requested that post-acute and long-term care practices be considered separately in this proposal. The commenter indicated that grouping them with their specialty peers practicing in a traditional ambulatory setting creates inequities. In particular, the commenter noted that benchmarks and thresholds are not comparable due to the different natures of the types of practice.

Response: We recognize that groups will have varying compositions and note that groups have the option to report at the individual level or group level. In section II.E.3.c. of this final rule with comment period, we describe the low-volume threshold exclusion which is applied at the individual eligible clinician level or the group level. A group that would not be excluded from MIPS when reporting at a group level may find it advantageous to report at the individual level.

After consideration of the public comments we received, we are finalizing a modification to our proposal regarding the use of a group's billing TIN to identify a group. Thus, we are codifying the definition of a group at § 414.1305 to mean a group that consists of a single TIN with two or more eligible clinicians (including at least one MIPS eligible clinician), as identified by their individual NPI, who have reassigned their billing rights to the TIN.

c. APM Entity Group Identifier for Performance

We proposed the following way to identify a group to support APMs (see section II.F.5.b. of this rule). To ensure we have accurately captured all of the eligible clinicians identified as participants that are participating in the APM Entity, we proposed that each eligible clinician who is a participant of an APM Entity would be identified by a unique APM participant identifier. The unique APM participant identifier would be a combination of four identifiers: (1) APM Identifier (established by CMS; for example, XXXXXX); (2) APM Entity identifier (established under the APM by CMS; for example, AA00001111); (3) TIN(s) (9 numeric characters; for example, XXXXXXXXX); (4) EP NPI (10 numeric characters; for example, 1111111111). For example, an APM participant identifier could be APM XXXXXX, APM Entity AA00001111, TIN-XXXXXXXXX, NPI-11111111111.

We proposed to codify the definition of an APM Entity group at § 414.1305 as an APM Entity identified by a unique APM participant identifier. We requested comments on these proposals. See section II.E.5.h. of the proposed rule for proposed policies regarding requirements for APM Entity groups under MIPS.

The following is a summary of the comments we received regarding our proposal establishing the way each eligible clinician who is a participant of an APM Entity would be identified by a unique APM participant identifier.

Comment: Several commenters supported the approach to identify APM professionals by a combination of APM identifier, APM entity identifier, TIN and NPI. Commenters requested that CMS make the QP identifiers available via an application program interface (API), which would improve an APM participant's ability to provide accurate and timely reports. However, one commenter recommended that an APM Entity group be defined using a unique APM participant identifier composed of a combination of four, cross-referenced identifiers: APM ID, MIPS ID, TIN, and NPI. The commenter shared that their Shared Savings Program experience with their ACO Identifier has been very positive, and suggested that MIPS adopt a similar definition and use the APM-MIPS ID for day-to-day APM identification, versus the proposed alternative.

Response: We appreciate the support and suggestions from the commenters. As we operationalize the process for APM Entity identifiers, we will taking into consideration the recommendation of making the QP identifier available via an API. In regard to suggestion regarding the APM Entity group identifier, we do not believe it is necessary to create an additional MIPS ID for the purposes of tracking APM Entities under MIPS. We further note that for all APMs, the APM Entity identifiers are the same identifiers that are currently used by CMS for other purposes. For example, in the case of the Shared Savings Program, since ACOs are the participating APM Entity, the APM Entity identifier would be the same as the ACO Identifier. We believe that tracking APM Entity participation in this way is most consistent with how CMS currently tracks APM Entity participation, and eliminates any unnecessary burden of tracking any new, additional identifiers.

Comment: One commenter requested clarification on the use of the APM participant identifier and whether the APM participant identifier would be a required data element for submission.

Response: We note that the APM Identifier will be used to ensure accurate tracking of all APM participants and comprised of the four already existing identifiers that are described in this section. In regard to the data elements required for the submission of data via a submission mechanism, the required data elements will depend on the requirements for each data submission mechanism. The submission procedures for each data submission mechanism will be further outlined in subregulatory guidance.

Comment: One commenter did not support the proposal regarding how an APM Entity group would be defined. The commenter requested clarification as to why an APM participant could not be identified by a combination of TIN/NPI, and a single character prefix or suffix to denote the eligible clinician is part of an APM entity.

Response: We appreciate the feedback from the commenter. We note that our proposal to use the APM ID, APM Entity Identifier, TIN and NPI is most consistent with how APM participation Start Printed Page 77060is currently tracked within our systems. Introducing another method of identification, such as a single character prefix or suffix, would be a deviation from our already existing operational processes, and we do not foresee that such a deviation would add any program efficiencies or facilitate participant tracking.

Comment: One commenter did not support mandatory reporting and participation, and indicated that ACOs are an example of forcing participation in alternative payment models resulting in the failure to save money and difficulties to retain participants.

Response: We appreciate the concerns from the commenter and note that participation in MIPS is mandatory while participation in an ACO (or APM) is voluntary. Based on the results generated to date under the Shared Savings Program, the data suggests that the longer organizations stay in the Shared Savings Program, the more likely they are able to achieve savings. Also, the number of organizations participating in the Shared Savings Program is increasing annually.

Comment: One commenter recommended that CMS take into account the burden placed on certain subspecialties that may not and will not have the flexibility to participate in many current APMs. Another commenter recommended that CMS identify specialties and subspecialties currently unable to participate in Advanced APMs and establish ways to minimize their burden and risk of receiving a penalty under MIPS.

Response: We thank the commenters for expressing their concerns. As we develop the operational elements of the MIPS program, we strive to establish a process ensuring that participation in MIPS can be successful. Based on the experience and feedback provided by stakeholders regarding previously established CMS programs, we are improving and enhancing the user-experience for MIPS. We will continue to seek stakeholder feedback as we implement the MIPS program.

After consideration of the public comments we received, we are finalizing our proposal that each eligible clinician who is a participant of an APM Entity will be identified by a unique APM participant identifier. The unique APM participant identifier will be a combination of four identifiers: (1) APM Identifier (established by CMS; for example, XXXXXX); (2) APM Entity identifier (established under the APM by CMS; for example, AA00001111); (3) TIN(s) (9 numeric characters; for example, XXXXXXXXX); (4) EP NPI (10 numeric characters; for example, 1111111111). For example, an APM participant identifier could be APM XXXXXX, APM Entity AA00001111, TIN-XXXXXXXXX, NPI-11111111111. Thus, we are codifying the definition of an APM Entity group at § 414.1305 to mean a group of eligible clinicians participating in an APM Entity, as identified by a combination of the APM identifier, APM Entity identifier, Taxpayer Identification Number (TIN), and National Provider Identifier (NPI) for each participating eligible clinician.

3. Exclusions

a. New Medicare-Enrolled Eligible Clinician

Section 1848(q)(1)(C)(v) of the Act provides that in the case of a professional who first becomes a Medicare-enrolled eligible clinician during the performance period for a year (and had not previously submitted claims under Medicare either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier), that the eligible clinician will not be treated as a MIPS eligible clinician until the subsequent year and performance period for that year. In addition, section 1848(q)(1)(C)(vi) of the Act clarifies that individuals who are not deemed MIPS eligible clinicians for a year will not receive a MIPS payment adjustment. Accordingly, we proposed at § 414.1305 that a new Medicare-enrolled eligible clinician be defined as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and who has not previously submitted claims as a Medicare-enrolled eligible clinician either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier. These eligible clinicians will not be treated as a MIPS eligible clinician until the subsequent year and the performance period for such subsequent year. As discussed in section II.E.4. of the proposed rule (81 FR 28179 through 28181), we proposed that the MIPS performance period would be the calendar year (January 1 through December 31) 2 years prior to the year in which the MIPS payment adjustment is applied. For example, an eligible clinician who newly enrolls in Medicare within PECOS in 2017 would not be required to participate in MIPS in 2017, and he or she would not receive a MIPS payment adjustment in 2019. The same eligible clinician would be required to participate in MIPS in 2018 and would receive a MIPS payment adjustment in 2020, and so forth. In addition, in the case of items and services furnished during a year by an individual who is not an MIPS eligible clinician, there will not be a MIPS payment adjustment applied for that year. We also proposed at § 414.1310(d) that in no case would a MIPS payment adjustment apply to the items and services furnished by new Medicare-enrolled eligible clinicians. We requested comments on these proposals.

The following is a summary of the comments we received regarding our proposals to define a new Medicare-enrolled eligible clinician as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and who has not previously submitted claims under Medicare either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier, that the eligible clinician would not be treated as a MIPS eligible clinician until the subsequent year and performance period for such subsequent year, that a MIPS payment adjustment would not be applied in the case of items and services furnished during a year by an individual who is not an MIPS eligible clinician, and that in no case would a MIPS payment adjustment apply to the items and services furnished by new Medicare-enrolled eligible clinicians.

Comment: One commenter recommended postponing the implementation of the “new” types of clinicians to a later effective date.

Response: We appreciate the suggestion from the commenter, but note that we do not find it necessary or justifiable to postpone the implementation of the new Medicare-enrolled eligible clinician provision.

Comment: One commenter requested clarification on how CMS would require clinicians who are new Medicare-enrolled eligible clinicians to participate in MIPS after their first 12 months of Medicare enrollment passed.

Response: We note that section 1848(q)(1)(C)(v) of the Act provides that in the case of a professional who first becomes a Medicare-enrolled eligible clinician during the performance period for a year (and had not previously submitted claims under Medicare either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier), that the eligible clinician will not be treated as a MIPS eligible clinician until the subsequent year and performance period for that year. We note that new Medicare-enrolled eligible clinicians are excluded from MIPS during the performance period in which they are Start Printed Page 77061identified as being a new Medicare-enrolled eligible clinicians. For example, if an eligible clinician becomes a new Medicare-enrolled eligible clinician in April of a particular year, such eligible clinician would be excluded from MIPS until the subsequent year and performance period for that year, in which such eligible clinician would be required to participate in MIPS starting in January of the next year.

Moreover, section 1848(q)(1)(C)(vi) of the Act clarifies that individuals who are not deemed MIPS eligible clinicians for a year will not receive a MIPS payment adjustment. Accordingly, we define a new Medicare-enrolled eligible clinician as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and who has not previously submitted claims as a Medicare-enrolled eligible clinician either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier. These eligible clinicians will not be treated as a MIPS eligible clinician until the subsequent year and the performance period for such subsequent year. Thus, such eligible clinicians would be treated as a MIPS eligible clinician in their subsequent year of being a Medicare-enrolled eligible clinician, required to participate in MPS, and subject to the MIPS payment adjustment for the performance period of that subsequent year.

Comment: One commenter requested clarification on clinicians' eligibility under MIPS and their designation on whether they are Medicare or Medicaid-enrolled from year to year.

Response: In section II.E.1.a. of this final rule with comment period, we define a MIPS eligible clinician. Clinicians meeting the definition of a MIPS eligible clinician are required to participate in MIPS unless eligible for an exclusion as defined in section II.E.3. of this final rule with comment period. For purposes of MIPS, we are able to identify an eligible clinician who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and who has not previously submitted claims as a Medicare-enrolled eligible clinician either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier.

Comment: Several commenters supported the exclusion of new Medicare-enrolled eligible clinicians from MIPS; however, commenters indicated that it is unreasonable to require new Medicare-enrolled eligible clinicians to begin participating in MIPS during the next performance period, especially those that become new Medicare-enrolled eligible clinicians later in the year. The commenters recommended giving new Medicare-enrolled eligible clinicians the option of being excluded from MIPS in both the performance period in which they begin treating Medicare patients and in the following performance period. One commenter opposed CMS's proposal that clinicians newly enrolling in Medicare in 2017 would have to participate in MIPS starting January 1, 2018, and requested that CMS instead extend the window so that clinicians enrolling in Medicare in 2017 would not begin participation until January 1, 2019. Another commenter suggested that CMS consider new Medicare-enrolled eligible clinicians ineligible for MIPS until the first performance period following at least 12 months of enrollment in Medicare.

Response: We thank the commenters for expressing their concerns. While the statute does not give the Secretary discretion to further delay MIPS participation for these eligible clinicians, we note that in the transition year (CY 2017) and performance period for such year in which an eligible clinician is treated as a MIPS eligible clinician, the clinician may qualify for an exclusion under the low-volume threshold. We refer readers to section II.E.3.c. of this final rule with comment period, which further describes the low-volume threshold provision.

Comment: A few commenters supported CMS' proposal that a new Medicare-enrolled eligible clinician would not be eligible to participate in the MIPS program until the subsequent performance period.

Response: We appreciate the support from the commenters.

Comment: A few commenters offered recommendations pertaining to exemptions that CMS should consider. One commenter suggested that medical/surgical practices of 15 professionals or fewer be fully exempt from MIPS; otherwise, many Medicare patients risk losing access to physicians who have cared for them for many years. Another commenter recommended that MIPS eligible clinicians who are a Tier 1 or part of a Center of Excellence or a High Quality Provider with a private insurer should be exempt from penalties because they are a proven benefit to the system already and should not be penalized.

Response: We appreciate the commenters providing their recommendations. We note that the suggestions are out-of-scope to proposals described in the proposed rule (81 FR 28161) and iterate that the statute only allows for limited exceptions for eligible clinicians to be exempt from the MIPS requirements.

Comment: One commenter encouraged CMS to only use exceptions and special cases as outlined in the proposed rule when absolutely necessary because the creation of exceptions, exclusions, and multiple performance pathways would introduce unnecessary reporting burden for participating MIPS eligible clinicians.

Response: We thank the commenter for the suggestion and note that in this final rule with comment period, we are finalizing our proposed exclusions pertaining to new Medicare-enrolled eligible clinicians and QPs and Partial QPs, and modifying our proposed exclusion pertaining to the low-volume threshold, as discussed in sections II.E.3.a., II.E.3.b., and II.E.3.c., of this final rule with comment period.

After consideration of the public comments we received, we are finalizing the definition of a new Medicare-enrolled eligible clinician at § 414.1305 as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and had not previously submitted claims under Medicare such as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier. We are finalizing our proposal at § 414.1310(c) that these eligible clinicians will not be treated as a MIPS eligible clinician until the subsequent year and the performance period for such subsequent year. As outlined in section II.E.4. of this final rule with comment period, we are finalizing a modification to the MIPS performance period to be a minimum of one continuous 90-day period within CY 2017. In the case of items and services furnished during a year by an individual who is not a MIPS eligible clinician during the performance period, there will not be a MIPS payment adjustment applied for that payment adjustment year. Additionally, we are finalizing our proposal at § 414.1310(d) that in no case would a MIPS payment adjustment apply to the items and services furnished during a year by new Medicare-enrolled eligible clinicians for the applicable performance period.

We believe that it would be beneficial for eligible clinicians to know during the performance period of a calendar year whether or not they are identified as a new Medicare-enrolled eligible clinician. For purposes of this section, Start Printed Page 77062we are coining the term “new Medicare-enrolled eligible clinician determination period” and define it to mean the 12 months of a calendar year applicable to the performance period. During the new Medicare-enrolled eligible clinician determination period, we will conduct eligibility determinations on a quarterly basis to the extent that is technically feasible in order to identify new Medicare-enrolled eligible clinicians that would be excluded from the requirement to participate in MIPS for the applicable performance period. Given that the performance period is a minimum of one continuous 90-day period within CY 2017, we believe it would be beneficial for such eligible clinicians to be identified as being excluded from MIPS requirements on a quarterly basis in order for individual eligible clinicians or groups to plan and prepare accordingly. For future years of the MIPS program, we will conduct similar eligibility determinations on a quarterly basis during the new Medicare-enrolled eligible clinician determination period, which consists of the 12 months of a calendar year applicable to the performance period, in order to identify throughout the calendar year eligible clinicians who would excluded from MIPS as a result of first becoming new Medicare-enrolled eligible clinicians during the performance period for a given year.

b. Qualifying APM Participant (QP) and Partial Qualifying APM Participant (Partial QP)

Sections 1848(q)(1)(C)(ii)(I) and (II) of the Act provide that the definition of a MIPS eligible clinician does not include, for a year, an eligible clinician who is a Qualifying APM Participant (QP) (as defined in section 1833(z)(2) of the Act) or a Partial Qualifying APM Participant (Partial QP) (as defined in section 1848(q)(1)(C)(iii) of the Act) who does not report on the applicable measures and activities that are required under MIPS. Section II.F.5. of the proposed rule provides detailed information on the determination of QPs and Partial QPs.

We proposed that the definition of a MIPS eligible clinician at § 414.1310 does not include QPs (defined at § 414.1305) and Partial QPs (defined at § 414.1305) who do not report on applicable measures and activities that are required to be reported under MIPS for any given performance period. Partial QPs will have the option to elect whether or not to report under MIPS, which determines whether or not they will be subject to MIPS payment adjustments. Please refer to the section II.F.5.c. of the proposed rule where this election is discussed in greater detail. We requested comments on this proposal.

The following is a summary of the comments we received regarding our proposal that the definition of a MIPS eligible clinician does not include QPs (defined at § 414.1305) and Partial QPs (defined at § 414.1305) who do not report on applicable measures and activities that are required to be reported under MIPS for any given performance period, in which Partial QPs will have the option to elect whether or not to report under MIPS.

Comment: One commenter recommended that CMS consider presumptive QP status in the first performance year, and prospective notification of QP status based on prior year thresholds. Alternatively, if in the year following the performance year CMS determines the Advanced APM Entity has not yet met the required threshold score, the commenter indicated that CMS could either: Assign the entity's participating clinicians a neutral MIPS score without a penalty or reward; or allow them to complete two of the four MIPS performance categories in 2018 and have the results count for 2019 payments.

Response: We refer readers to section II.F.5 of this final rule with comment period for policies regarding QP and Partial QP determinations.

After consideration of the public comments we received, we are finalizing our proposal at § 414.1305 that the definition of a MIPS eligible clinician does not include QPs (defined at § 414.1305) and Partial QPs (defined at § 414.1305) who do not report on applicable measures and activities that are required to be reported under MIPS for any given performance period in a year. Also, we are finalizing our proposed policy at § 414.1310(b) that for a year, QPs (defined at § 414.1305) and Partial QPs (defined at § 414.1305) who do not report on applicable measures and activities that are required to be reported under MIPS for any given performance period in a year are excluded from MIPS. Partial QPs will have the option to elect whether or not to report under MIPS, which determines whether or not they will be subject to MIPS payment adjustments.

c. Low-Volume Threshold

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

We proposed at § 414.1305 to define MIPS eligible clinicians or groups who do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the performance period, have Medicare billing charges less than or equal to $10,000 and provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. We believed this strategy holds more merit as it retains as MIPS eligible clinicians those MIPS eligible clinicians who are treating relatively few beneficiaries, but engage in resource intensive specialties, or those treating many beneficiaries with relatively low-priced services. By requiring both criteria to be met, we can meaningfully measure the performance and drive quality improvement across the broadest range of MIPS eligible clinician types and specialties. Conversely, it excludes MIPS eligible clinicians who do not have a substantial quantity of interactions with Medicare beneficiaries or furnish high cost services.

In developing this proposal, we considered using items and services furnished to Part B-enrolled individuals by the MIPS eligible clinician for a particular performance period rather than patients, but a review of the data reflected there were nominal differences between the two methods. We plan to monitor the proposed requirement and anticipate that the specific thresholds will evolve over time. We requested comments on this proposal including alternative patient threshold, case thresholds, and dollar values.

The following is a summary of the comments we received regarding our proposal to define MIPS eligible clinicians or groups who do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the performance period, have Medicare billing charges less than or equal to $10,000 and provides care for 100 or fewer Part B-enrolled Medicare beneficiaries.Start Printed Page 77063

Comment: A few commenters supported the proposed policy to exempt MIPS eligible clinicians or groups from MIPS requirements who do not exceed the low-volume threshold of having Medicare billing charges less than or equal to $10,000 and providing care for 100 or fewer Part B-enrolled Medicare beneficiaries. In particular, one commenter expressed support for the dual criteria of the low-volume threshold (Medicare billing charges less than or equal to $10,000 and providing care for 100 or fewer Part B-enrolled Medicare beneficiaries).

Response: We appreciate the support from the commenters.

Comment: A significant portion of commenters expressed concern regarding our proposed low-volume threshold provision, particularly the requirement for MIPS eligible clinicians and groups to meet both the low-volume threshold pertaining to the dollar value of Medicare billing charges and the number of Medicare Part B beneficiaries cared for during a performance period. The commenters requested that CMS modify the criteria under the definition of MIPS eligible clinicians or groups who do not exceed the low-volume threshold to require that an individual MIPS eligible clinician or group would need to meet either the low-volume threshold pertaining to the dollar value of Medicare billing charges or the number of Medicare Part-B beneficiaries cared for during a performance period in order to determine whether or not an individual MIPS eligible clinician or group exceeds the low-volume threshold. Several commenters noted that such a change would provide greater flexibility for specialty clinicians.

Response: We appreciate the concerns expressed by commenters. We agree with the commenters and have modified our proposal to not require that MIPS eligible clinicians and groups must meet both the dollar value of Medicare billing charges and the number of Medicare Part B beneficiaries cared for during a performance period. Instead, we are finalizing that individual MIPS eligible clinicians and groups meet either the threshold of $30,000 in billed Medicare Part B allowed charges or the threshold of 100 or fewer Part B-enrolled Medicare beneficiaries. Also, we believe that the modified proposal reduces the risk of clinicians withdrawing as Medicare suppliers and minimizing the number of Medicare beneficiaries that they treat in a year. We will monitor any effect on Medicare participation. Similar to the goal of the proposed low-volume threshold, we believe that this modified approach holds more merit as it retains as MIPS eligible clinicians those MIPS eligible clinicians who are treating relatively few beneficiaries, but engage in resource intensive specialties, or those treating many beneficiaries with relatively low-priced services. We believe that the modified proposal would also ensure that we can meaningfully measure the performance and drive quality improvement across a broad range of MIPS eligible clinician types and specialties. We note that eligible clinicians who are excluded from the definition of a MIPS eligible clinician under the low-volume threshold or another applicable exclusion can still participate voluntarily in MIPS, but are not subject to positive or negative MIPS adjustments. For future consideration, we are seeking additional comment on possible ways that excluded eligible clinicians might be able to opt-in to the MIPS program (and the MIPS payment adjustment) in future years in a manner consistent with the statute.

Comment: The majority of commenters recommended that CMS increase the low-volume threshold. A signification portion of commenters requested that MIPS eligible clinicians or groups who do not exceed the low-volume threshold should have Medicare billing charges less than or equal to $30,000 or provide care for 100 or fewer Part B-enrolled Medicare beneficiaries. Many commenters noted that raising the low-volume threshold would allow more physicians with a small number of Medicare patients to be recognized as MIPS eligible clinicians or groups who do not exceed the low-volume threshold, particularly MIPS eligible clinicians providing specialty services or high risk services. Several commenters indicated that women on Medicare receive expensive surgical care from OB/GYNs, which could cause MIPS eligible clinicians and groups to exceed the proposed low-volume threshold despite a very small number of Medicare patients. The commenters suggested that CMS exempt MIPS eligible clinicians and groups from the MIPS program who have less than $30,000 in Medicare allowed charges per year or provide care for fewer than 100 unique Medicare Part-B beneficiaries.

A few commenters indicated that an increase in the low-volume threshold would mitigate an undue burden on small practices. One commenter stated that RHCs and such clinicians will have fewer than $10,000 in Medicare billing charges, but many of them will have more than 100 Part B beneficiaries under their care. The commenter expressed concern that RHCs may be burdened with MIPS requirements for a low level of Part B claims and thus, may either face penalties or the cost of implementing the MIPS requirements. A few commenters indicated that the low-volume threshold should be high enough to exempt physicians who have no possibility of a positive return on their investment in the cost of reporting.

Other recommendations from commenters included the following: align the patient cap with the CPC+ patient panel requirements, which would increase the number of Medicare Part B beneficiaries cared for to 150 (and would prevent clinicians from having two different low-volume thresholds within the same program); exclude groups from participation in MIPS based on an aggregated threshold for the group with the rate of $30,000 and 100 patients per clinician, in which a group of two eligible clinicians would be excluded if charging under $60,000 and caring for under 200 Medicare Part B-enrolled Medicare beneficiaries; exempt MIPS eligible clinicians for the transition year of MIPS who bill under Place of Service 20, which is the designation for a place with the purpose of diagnosing and treating illness or injury for unscheduled, ambulatory patients seeking immediate medical attention; and exempt facilities operating in Frontier areas from MIPS participation, at least until 2019 when the list of MIPS eligible clinicians expands and additional MIPS eligible clinicians are able to participate in MIPS.

There were other commenters who requested that the threshold criteria regarding the dollar value of Medicare billed charges and the number of Medicare Part B beneficiaries cared for be increased to the following: $25,000 Medicare billed charges or 50 or 100 Part B beneficiaries; $50,000 Medicare billed charges or 100 or 150 Part B beneficiaries; $75,000 Medicare billed charges or 100 or 750 Part B beneficiaries; $100,000 Medicare billed charges or 1000 Part B beneficiaries; $250,000 Medicare billed charges or 150 Part B beneficiaries; and $500,000 Medicare billed charges or 400 or 500 Part B beneficiaries.

Several commenters requested that CMS temporarily increase the low-volume threshold in order for small practices to not be immediately impacted by the implementation of MIPS. One commenter suggested that the threshold be increased to 250 unique Medicare patients and a total Medicare billing not to exceed $200,000 for 5 years. Another commenter recommended that CMS set the low-volume threshold in 2019 at $250,000 of Start Printed Page 77064Medicare billing charges. The commenter explained that at such amount, the avoided penalties at 4 percent would approximately equal the $10,000 cost of reporting and below such amount, there would not likely be a return that exceeds the costs of reporting. Below such amount, the commenter suggested CMS make MIPS participation optional, but MIPS eligible clinicians that participate would be exempt from any penalties.

Response: We appreciate the concerns and recommendations provided by the commenters. We received a range of suggestions and considered the various options. We agree with commenters that the dollar value of the low-volume threshold should be increased and that the low-volume threshold should not require MIPS eligible clinicians and groups to be required to meet both the dollar value of billed Medicare Part B allowed charges and the Part B Medicare-enrolled beneficiary count thresholds at this time. We believe it is important to establish a low-volume threshold that is responsive to stakeholder feedback. Some of the recommended options would have established a threshold that would exclude many eligible clinicians who would otherwise want to participate in MIPS. The majority of commenters suggested that the low-volume threshold be changed to reflect $30,000 or less billed Medicare Part B allowed charges. As a result, we are modifying our proposal. We are defining MIPS eligible clinicians or groups who do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the low-volume threshold determination period, has billed Medicare Part B allowed charges less than or equal to $30,000 or provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. This policy would be more robust and effective at excluding clinicians for whom submitting data to MIPS may represent a disproportionate burden with a secondary effect of allowing greater concentration of technical assistance on a smaller cohort of practices. We believe that the higher low-volume threshold addresses the concerns from commenters while remaining consistent with the proposal and having a policy that is easy to understand.

Comment: A few commenters indicated that it would be difficult for psychologists to determine ahead of time if they met the low-volume threshold relating to the dollar value of $10,000 Medicare billing charges in order to be exempt from MIPS, yet it would be relatively easy for psychologists to determine whether they are likely to have fewer than 100 Medicare patients in a given year based on their historical volume of Medicare patients. Several commenters requested CMS to change the low-volume threshold requirement to state “$10,000 in Medicare charges or fewer than 100 beneficiaries,” making it possible for psychologists to be exempt from MIPS, which is essential in keeping them enrolled in Medicare provider panels. A few commenters expressed concerns that if the proposed low-volume threshold was finalized as is, psychologists and psychotherapists who see Medicare beneficiaries weekly or bi-weekly would be unable to meet Medicare patients’ demand for psychotherapy, would discontinue seeing Medicare beneficiaries altogether, and would be reluctant to participate in MIPS if they were not exempted from MIPS participation. Commenters stated that CMS violates the Mental Health Parity and Addiction Equity Act of 2008 by having separate rules for medical versus psychological illnesses.

Response: As previously noted, we are finalizing a modification to proposal, in which we are defining MIPS eligible clinicians or groups who do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the performance period, has billed Medicare Part B allowed charges less than or equal to $30,000 or provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. Thus, a MIPS eligible clinician or a group would only need to meet the dollar value or the beneficiary count for the low-volume threshold exclusion. As a result, psychologists will be able to easily discern whether or not they exceed the low-volume threshold. In addition, we intend to provide a NPI level lookup feature prior to or shortly after the start of the performance period that will allow clinicians to determine if they do not exceed the low-volume threshold and are therefore excluded from MIPS. More information on this NPI level lookup feature will be made available at QualityPaymentProgram.cms.gov.

In regard to the comment pertaining to the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA), we note that the MHPAEA generally prevents group health plans and health insurance issuers that provide mental health or substance use disorder benefits from imposing less favorable benefit limitations on those benefits than on medical/surgical benefits. The mental health parity requirements of MHPAEA do not apply to Medicare.

Comment: One commenter indicated that the low-volume threshold is too low for a group and requested that CMS either establish a certain exclusion threshold based on group size, or exclude a group if more than 50 percent of its MIPS eligible clinicians meet the low-volume threshold. Another commenter recommended CMS to establish a low-volume threshold based upon practice size, so that solo practices and those with less than 10 clinicians are ineligible for MIPS. The commenter noted that the financial and reporting burden of participating in MIPS would be too great for such clinicians.

Response: We appreciate the concern and suggestions from the commenters and note that we are modifying our proposed low-volume threshold by increasing the dollar value of the billed Medicare Part B allowed charges and eliminating the requirement that the clinician meet both the dollar value and beneficiary count thresholds. MIPS eligible clinicians or groups that do not exceed the low-volume threshold of $30,000 billed Medicare Part B allowed charges or provide care for 100 or fewer Part B-enrolled Medicare beneficiaries would be excluded from MIPS. We apply the same low-volume threshold to both individual MIPS eligible clinicians and groups because groups have the option to elect to report at an individual or group level. A group that would be excluded from MIPS when reporting at a group level may find it advantageous to report at the individual level.

Comment: One commenter suggested that CMS exclude Part B and Part D drug costs from the low-volume threshold determination to mitigate the impacts of MIPS on community practices in rural and underserved areas.

Response: We appreciate the suggestion from the commenter and note that the low-volume threshold applies to Medicare Part B allowed charges billed by the eligible clinician, such as those under the PFS.

Comment: One commenter stated that CMS should provide education and training to MIPS eligible clinicians and groups meeting the low-volume threshold.

Response: We are committed to actively engaging with all stakeholders, including tribes and tribal officials, throughout the process of establishing and implementing MIPS and using various means to communicate and inform MIPS eligible clinicians and groups of the MIPS requirements. In addition, we intend to provide a NPI level lookup feature prior to or shortly after the start of the performance period that will allow clinicians to determine Start Printed Page 77065if they do not exceed the low-volume threshold and are therefore excluded from MIPS. More information on this NPI level lookup feature will be made available at QualityPaymentProgram.cms.gov.

Comment: One commenter requested that a definition of “Medicare billing charges” be established under the low-volume threshold policy. The commenter also requests a modification to this term so that it reads “allowed amount” so that it is clear that the $10,000 threshold is calculated based on $10,000 of Medicare-allowed services.

Response: We appreciate the suggestions from the commenter and note that the low-volume threshold pertains to Medicare Part B allowed charges billed by a MIPS eligible clinician, such as those under the PFS. In order to be consistent with the statute, we assess the allowed charges billed to determine whether or not an eligible clinician exceeds the low-volume threshold. Also, we specify that the allowed charges billed relate to Medicare Part B.

Comment: One commenter noted that since MIPS eligibility is based on the current reporting period, a clinician would not definitively know if he or she is excluded until the end of the year. It would be helpful if eligibility would be based on a prior period, as is currently done for hospital-based determinations for EPs under the EHR Incentive Program. This is especially problematic for low-volume clinicians such as OB/GYN, because eligibility might change from year to year. Another commenter questioned why the low-volume threshold for a MIPS eligible clinician is calculated based on the performance year rather than basing the calculation on the previous year.

Response: We agree that it would be beneficial for individual eligible clinicians and groups to know whether they are excluded under the low-volume threshold prior to the start of the performance period and thus, we are finalizing a modification to our proposal to allow us to make eligibility determinations regarding low-volume status using historical claims data. This modification will allow us to inform individual MIPS eligible clinicians and groups of their low-volume status prior to or shortly after the start of the performance period. For purposes of this section, we are coining the term “low-volume threshold determination period” to refer to the timeframe used to assess claims data for making eligibility determinations for the low-volume threshold exclusion. We define the low-volume threshold determination period to mean a 24-month assessment period, which includes a two-segment analysis of claims data during an initial 12-month period prior to the performance period followed by another 12-month period during the performance period. The initial 12-month segment of the low-volume threshold determination period would span from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and include a 60-day claims run out, which will allow us to inform eligible clinicians and groups of their low-volume status during the month (December) prior to the start of the performance period. To conduct an analysis of the claims data regarding Medicare Part B allowed charges billed prior to the performance period, we are establishing an initial segment of the low-volume threshold determination period consisting of 12 months. We believe that the initial low-volume threshold determination period enables us to make eligibility determinations based on 12 months of data that is as close to the performance period as possible while informing eligible clinicians of their low-volume threshold status prior to the performance period. The second 12-month segment of the low-volume threshold determination period would span from the last 4 months of a calendar year 1 year prior to the performance period followed by the first 8 months of the performance period in the next calendar year and include a 60-day claims run out, which will allow us to inform additional eligible clinicians and groups of their low-volume status during the performance period.

Thus, for purposes of the 2019 MIPS payment adjustment, we will initially identify the low-volume status of individual eligible clinicians and groups based on 12 months of data starting from September 1, 2015 to August 31, 2016, with a 60 day claims run out. To account for the identification of additional individual eligible clinicians and groups who do not exceed the low-volume threshold during the 2017 performance period, we will conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2016 to August 31, 2017, with a 60 day claims run out. For example, MIPS eligible clinicians who may have exceeded the low-volume threshold during the first determination assessment, but fall below the threshold during the performance period because their practice changed significantly, they changed practices from a prior year, etc.

In addition, we note that the low-volume threshold exclusion is determined at the individual (TIN/NPI) level for individual reporting and at the group (TIN) level for group reporting. An eligible clinician may be identified as having a status that does not exceed the low-volume threshold at the individual (TIN/NPI) level, but if such eligible clinician is part of a group that is identified as having a status exceeding the low-volume threshold, such eligible clinician would be required to participate in MIPS as part of the group because the low-volume threshold is determined at the group (TIN) level for groups. For eligibility determinations pertaining to the low-volume threshold exclusion, we will be conducting our analysis for each TIN/NPI and TIN identified in the claims data and make a determination based on the Medicare Part B allowed charges billed. Since we are making eligibility determinations for each TIN/NPI and TIN identified in the claims data, we do not need to know whether or not a group is reporting at the individual or group level prior to our analyses. Thus, groups can use the eligibility determinations we make for each TIN/NPI and TIN to determine whether or not their group would be reporting at the individual or group level. Subsequently, groups reporting at the group level would need to meet the group requirements as discussed in section II.E.3.d. of this final rule with comment period.

Comment: One commenter requested that CMS ensure that low-volume threshold exclusion and other exclusions would not penalize practices with more pediatric, women's health, Medicaid, or private insurance patients.

Response: We recognize that groups will have different patient populations. As previously noted, we are finalizing a modified low-volume threshold policy that will increase the number of individual eligible clinicians and groups excluded from the requirement to participate in MIPS, which would include individual eligible clinicians and groups with more pediatric, women's health, Medicaid, or private insurance patients if they have not billed more than $30,000 of Medicare Part B allowed charges or provided care for more than 100 Part B-enrolled Medicare beneficiaries. We note that MIPS eligible clinicians who are excluded from MIPS have the option to voluntarily participate in MIPS, but would not receive a MIPS payment adjustment.

Comment: One commenter requested more information about whether the low-volume threshold will be Start Printed Page 77066eliminated in future years and if there is a potential for an incentive payment when an eligible clinician meets the low-volume threshold but elects to report anyway.

Response: We intend to monitor the low-volume threshold requirement and anticipate that the specific threshold will evolve over time. For eligible clinicians who do not exceed the low-volume threshold and are thus excluded from MIPS, they could voluntarily participate in MIPS, but would not be subject to the MIPS payment adjustment (positive or negative).

Comment: A few commenters requested clarification on the definition of the low-volume threshold including whether the $10,000 limit pertains to all Medicare billing charges or solely Medicare Part B charges, how this low-volume threshold applies to low-volume clinicians practicing in and reporting as a group, how beneficiaries are attributed to clinicians, and if there is a timeframe in which a patient was last seen.

Response: We note that the dollar value of low-volume threshold applies to Medicare Part B allowed charges billed by the eligible clinician. We note that eligibility determinations regarding low-volume threshold exclusion are based on claims data. As a result, we are able to identify Medicare Part B allowed charges billed by the eligible clinician and the number of Part B-enrolled Medicare beneficiaries cared for by an eligible clinician during the first and second low-volume threshold determination periods. For eligibility determinations regarding the low-volume threshold exclusion, we do not consider the timeframes of when a patient was last seen. In regard to how the low-volume threshold applies to MIPS eligible clinicians in groups, we apply the same low-volume threshold to both individual MIPS eligible clinicians and groups since groups have the option to report at an individual or group level. As a result of the low-volume threshold exclusion being determined at the individual (TIN/NPI) level for individual reporting and at the group (TIN) level for group reporting, there will be some eligible clinicians with a low-volume status that does not exceed the low-volume threshold who would be excluded from MIPS at the individual (TIN/NPI) level, but if such eligible clinicians are part of a group with a low-volume status that exceeds the low-volume threshold, such eligible clinicians would be required to participate in MIPS as part of the group. Section II.E.3.d. of this final rule with comment period describes how a group's (TIN) performance is assessed and scored at the group level and how the MIPS payment adjustment is applied at the group level when a group includes clinicians who are excluded from MIPS at the individual level.

Comment: Several commenters opposed holding individuals and groups to the same low-volume threshold standards. One commenter stated that basing the exclusion on two thresholds simultaneously would be antithetical to measurements of quality based on outcomes. The commenter noted that patient care can be very expensive and some eligible clinicians could be denied the low-volume threshold exclusion after seeing only a few very complex patients over the course of the performance period. Another commenter indicated that the proposed exclusionary criteria may lead to eligible clinicians in solo or small practices withdrawing as Medicare suppliers, or limiting the number of Medicare patients they treat over a performance period.

One commenter requested that CMS issue a clarification stating that when clinicians choose to have their performance assessed at the group level, the low-volume threshold would also be assessed at the group level. This would ensure consistent treatment. Another commenter requested clarity regarding the low-volume threshold exclusion definition for groups, and recommended that CMS apply a multiplying factor for each enrolled Medicare clinician in the group definition. One commenter recommended that CMS scale the minimum number of Part B-enrolled Medicare beneficiaries and Medicare billed charges to the number of physician group members while another commenter requested that if a practice reports as a group, the low-volume threshold should be multiplied by the number of clinicians in the group. Commenters recommended a higher threshold for groups.

A few commenters indicated that the current proposal does not provide a meaningful exclusion for small and rural practices that cannot afford the upfront investments (including investments in EHR systems) and as a result of the high costs to report for small practices, the threat of negative MIPS payment adjustments or low positive MIPS payment adjustments that do not cover the costs to report would deter small practices from participating in MIPS.

Response: We thank the commenters for their concerns and recommendations regarding the low-volume threshold. We recognize that the low-volume threshold proposed in section II.E.3.c. of the proposed rule (81 FR 28178) is a concern and as previously noted, we are modifying our proposal by increasing the dollar value of the billed Medicare Part B allowed charges and eliminating the requirement for MIPS eligible clinicians and groups to meet both the dollar value threshold and the 100 beneficiary count. In this final rule with comment period, we continue to apply the same low-volume threshold for both individual MIPS eligible clinicians and groups. We disagree with the comment regarding a percentage-based approach for groups because groups have the option of electing to report at an individual or group level. If a group elects not to report as a group, then each MIPS eligible clinician would report individually.

In addition, we believe that the modified proposal reduces the risk of clinicians withdrawing as Medicare suppliers and minimizing the number of Medicare beneficiaries that they treat in a year. We will monitor any effect on Medicare participation in CY 2017 and future calendar years.

Comment: Several commenters expressed concern that clinicians working in solo practices or small groups, especially in rural areas and HPSAs, would have difficulty meeting the requirements for MIPS. One commenter noted that non-board-certified doctors often work in these areas and are reimbursed at a lower rate than board-certified doctors. The commenters recommended that CMS make similar concessions for this category of clinicians as it proposed to do for non-patient facing MIPS eligible clinicians in the proposed rule. One commenter requested that small practice physicians and solo physicians in HPSAs be exempt from MIPS. The commenters requested that CMS ensure that small and solo practices have an equal opportunity to participate successfully in MIPS and Advanced APMs.

Response: We appreciate the concerns expressed by commenters and recognize that certain individual MIPS eligible clinicians and groups may only be able to report on a few, or possibly no, applicable measures and activities for the MIPS requirements. In section II.E.6.b.(2) of this final rule with comment period, we describe the re-weighting of each performance category when there are not sufficient measures and activities that are applicable and available. Also, our modified low-volume threshold exclusion policy increases the dollar value of Medicare Part B allowed charges billed by an eligible clinician, which will increase the number of eligible clinicians and groups excluded from MIPS and not subject to a negative MIPS payment Start Printed Page 77067adjustment, which may include additional solo or small rural or HPSA practices. We believe that rural areas, small practices, and HPSAs will benefit from other policies that we are finalizing throughout this final rule with comment period such as lower reporting requirements and lower performance threshold.

Comment: One commenter expressed concern that the MIPS program as outlined in the proposed rule would limit referrals to necessarily higher-cost small and rural providers. The commenter indicated that comparisons between small, rural practices and larger practices does not take into account differences in infrastructure and technological capabilities and patient populations which the commenter believed are more likely to be sick and poor in the rural settings. Another commenter expressed concern that rural clinicians who serve impoverished communities and do not have additional resources (for example, dieticians who can provide more hands-on care for diabetic patients) would be unfairly penalized if their patients do not comply with medical advice.

Response: We appreciate the concern expressed by the commenter and recognize that groups vary in size, clinician composition, patient population, resources, technological capabilities, geographic location, and other characteristics. While we believe the MIPS measures are valid and reliable, we will continue to investigate methods to ensure all clinicians are treated as fairly as possible within MIPS. As noted in this final rule with comment period, the Secretary is required to take into account the relevant studies conducted and recommendations made in reports under section 2(d) of the Improving Medicare Post-Acute Transformation (IMPACT) Act of 2014. Under the IMPACT Act, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) has been conducting studies on the issue of risk adjustment for sociodemographic factors on quality measures and cost, as well as other strategies for including social determinants of health status evaluation in CMS programs. We will closely examine the ASPE studies when they are available and incorporate findings as feasible and appropriate through future rulemaking. Also, we will monitor outcomes of beneficiaries with social risk factors, as well as the performance of the MIPS eligible clinicians who care for them to assess for potential unintended consequences such as penalties for factors outside the control of clinicians. We believe that rural clinicians and practices will benefit from other policies that we are finalizing throughout this final rule with comment period such as lower reporting requirements and lower performance threshold.

Comment: One commenter requested clarification as to whether or not non-patient facing MIPS eligible clinicians who are not based in a rural practice or not a member of a FQHC, but see fewer than 25 patients, would be exempt from MIPS. Another commenter requested clarification regarding whether or not the low-volume threshold applies if a physical therapist, occupational therapist, or speech-language pathologist is institution-based or nursing home-based.

Response: In both situations that the commenter raises, the clinician would be excluded from MIPS, however they would be excluded for different reasons. For the first example, the non-patient facing MIPS eligible clinician would be excluded due to seeing fewer than 25 patients, which falls below our finalized low-volume threshold exclusion. For the second example, the physical therapists, occupational therapists, or speech-language pathologist cannot be considered MIPS eligible clinicians until as early as the third year of the MIPS program.

Comment: One commenter proposed a phase-in period for small practices in addition to an increased low-volume threshold because the proposed rule did not immediately allow the opportunity for virtual groups that could provide the infrastructure to assist small practices. Additionally, the commenter believed that most small practices and solo physicians would not be ready to report on January 1, 2017. The commenter's recommended phase-in period would exempt the 40th percentile of all small and rural practices in each specialty in year 1; the 30th percentile of all small and rural practices in each specialty in year 2; the 20th percentile of all small and rural practices in each specialty in year 3; and the 10th percentile of all small and rural practices in each specialty in year 4. The commenter's recommended phase-in would be voluntary, and they believe it would provide more time for resource-limited small practices to prepare, finance new systems and upgrades, change workflows, and transition to MIPS.

Response: We appreciate the concerns and recommendations provided by the commenter. We recognize that small and rural practices may not have experience using CEHRT and/or may not be prepared to meet the MIPS requirements for each performance category. As described in this section of the final rule with comment period, we are modifying our proposal by increasing the dollar value of billed Medicare Part B allowed charges and eliminating the requirement for MIPS eligible clinicians and groups to meet both the dollar value threshold and the 100 beneficiary count, in which groups not exceeding the low-volume threshold would be excluded from the MIPS requirements. We believe our modified low-volume threshold is less complex with potentially a singular parameter determining low-volume status and addresses the commenter's concerns by providing exclusions for more individual MIPS eligible clinicians and groups, including small and rural practices. Also, in section II.E.5.g.(8)(a) of this final rule with comment period, we describe our final policies regarding the re-weighting of the advancing care information performance category within the final score, in which we would assign a weight of zero when there are not sufficient measures applicable and available.

Comment: A few commenters expressed concern that the proposed rule favored large practices, and requested that group practices with fewer than 10 or 15 physicians be excluded from MIPS. One commenter recommended that it may be more beneficial to expand the exclusion to practices under 15 physicians, thus reducing the number of practitioners that are going to opt out of Medicare altogether following MACRA and retaining a fairer adjustment distribution among the moderate and large practices.

Response: We thank the commenters for expressing their concerns and note that we are modifying our proposed low-volume threshold to apply to an individual MIPS eligible clinician or group who, during the low-volume threshold determination period, has billed Medicare Part B allowed charges less than or equal to $30,000 or provides care for 100 or few Part B-enrolled Medicare beneficiaries. We believe our modified proposal would increase the number of groups excluded from participating in MIPS based on the low-volume threshold, including group practices with fewer than 10 or 15 clinicians.

Comment: One commenter requested that CMS provide the underlying data that shows the distribution of spending and volume of cases on which the low-volume threshold is based. The commenter expressed concern that if the low-volume threshold is set too low, it may place too many clinicians close to the minimum of 20 attributable cases for resource use, which lacks statistical Start Printed Page 77068robustness. Another commenter suggested that CMS increase the low-volume threshold, as the commenter believed that counties with skewed demographics will give clinicians no chance to avoid negative MIPS payment adjustments. The commenter requested a moratorium on the implementation of MIPS until a study can be done that examines the potential effects of the law in such counties or for CMS to exempt practices that have a patient-population with more than 30 percent of its furnished services provided to Medicare Part B beneficiaries until the effects of the law are studied on the impact to these groups.

Response: We appreciate the concerns expressed by commenters regarding the proposed low-volume threshold and intend to monitor the effects of the low-volume threshold and anticipate that the specific thresholds will evolve over time. In this section of the final rule with comment period, we are modifying our proposed low-volume threshold, in which we are defining MIPS eligible clinicians or groups that do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the low-volume threshold determination period, has billed Medicare Part B allowed charges less than or equal to $30,000 or see fewer than 100 beneficiaries. In regard to the commenter's concern on having too many MIPS eligible clinicians near the minimum number of attributable cases for the cost performance category; we believe the increased low-volume threshold policy would reduce such risk and ensure statistical robustness. We also note that we have made a number of modifications within the cost performance category and refer readers to section II.E.5.e. of this final rule with comment period for the discussion of our modified policies.

Comment: One commenter requested that CMS calculate the projected data collection and reporting costs, the number of cases necessary to achieve statistical significance or reliability and comparison purposes, and the administrative costs on the agency to manage and calculate MIPS scores. With such costs in mind, the commenter requested that CMS adjust the low-volume threshold to a level such that MIPS would only apply to eligible clinicians for whom the costs of participating in the MIPS program outweighed the costs of refusing to accept Medicare patients. Otherwise, commenter was concerned that solo practitioners and small practices would opt out of treating Medicare patients.

Response: We thank the commenter for their suggestions and note that we are modifying our proposed low-volume threshold by increasing the dollar value of billed Medicare Part B allowed charges and eliminating the requirement for MIPS eligible clinicians and groups to meet both the dollar value threshold and the 100 beneficiary count. We believe our modified proposal would increase the number of groups excluded from participating in MIPS based on the low-volume threshold and prevent the low-volume threshold from being a potential factor that could influence a MIPS eligible clinician's decision to deny access to care for Medicare Part B beneficiaries or opt out of treating Medicare Part B beneficiaries. We refer readers to section III.B. of this final rule with comment period for our discussion regarding burden reduction.

Comment: For those eligible clinicians not participating in an ACO, one commenter requested clarification on the proposed $10,000 threshold, specifically, whether this includes payments made under the RHC all-inclusive rate (AIR) or FQHC prospective payment system. The commenter suggested that the $10,000 threshold should only include Part B PFS allowed charges because the other payment methodologies already are alternatives to fee schedules.

Response: In this section of the final rule with comment period, we are modifying our proposed low-volume threshold to be based on a dollar value of $30,000 of billed Medicare Part B allowed charges during a performance period or 100 Part B-enrolled beneficiary count, which would apply to clinicians in RHCs and FQHCs with billed Medicare Part B allowed charges.

Comment: A few commenters requested clarification on the low-volume threshold for clinicians who change positions frequently or work as locum tenens. The commenters requested CMS to clarify whether or not the threshold would be cumulative for these clinicians throughout the year as they bill under different TINs, or whether the threshold be specific to a TIN/NPI combination. Commenters recommended that the low-volume threshold be for a specific TIN in which a clinician may work.

Response: In sections II.E.2.a. and II.E.2.b. of this final rule with comment period, we describe the identifiers for MIPS eligible clinicians participating in MIPS at the individual or group level. For MIPS eligible clinicians reporting as individuals, we use a combination of billing TIN/NPI as the identifier to assess performance. In order to determine the low-volume status of eligible clinicians reporting individually, we will calculate the low-volume threshold for each TIN/NPI combination. For individual MIPS eligible clinicians billing under multiple TINs, the low-volume threshold is calculated for each TIN/NPI combination. In the case of an individual eligible clinician exceeding the low-volume threshold under any TIN/NPI combination, the eligible clinician would be considered a MIPS eligible clinician and required to meet the MIPS requirements for those TIN/NPI combinations.

Comment: One commenter suggested that CMS develop a MIPS hardship exception in addition to a low-volume threshold.

Response: We thank the commenter for the suggestion. We note that the section II.E.5.g.(8)(a)(ii) of this final rule with comment period describes our final policies regarding the re-weighting of the advancing care information performance category within the final score, in which we would assign a weight of zero when there are not sufficient measures applicable and available for MIPS eligible clinicians facing a significant hardship.

Comment: One commenter stated that the low-volume threshold should also take into account total Medicare patients and billing, including Medicare Advantage enrollees, not just Part B.

Response: We appreciate the suggestion from the commenter, but note that section 1848(q)(1)(C)(iv) of the Act establishes provisions relating to the low-volume threshold, in which the low-volume threshold only pertains to the number of Part B-enrolled Medicare beneficiaries, the number of items and services furnished to such individuals, or the amount of allowed charges billed under Part B. To the extent that Medicare Part B allowed charges are incurred for beneficiaries enrolled in section 1833(a)(1)(A) or 1876 Cost Plans, those the Medicare beneficiaries would be included in the beneficiary count; however, beneficiaries enrolled in Medicare Advantage plans that receive their Part B services through their Medicare Advantage plan will not be included in allowed charges billed under Medicare Part B for determining the low-volume threshold.

Comment: Regarding partial year performance data, one commenter indicated that the low-volume reporting threshold and “insufficient sample size” standard already proposed for MIPS are adequate, and no additional “partial year” criteria would be needed. For example, a clinician who only began billing Medicare in November and did not meet the low-volume threshold would not be eligible for MIPS. Another clinician who began billing Medicare in Start Printed Page 77069November who exceeds the low-volume threshold, even in such a short time period, would be eligible for MIPS. The commenter supported this approach because it is simple and straightforward and does not require any additional calculations.

Response: We appreciate the support from the commenter.

Comment: One commenter requested that CMS provide an exemption for physicians over 60 or 65 years old as they cannot afford to implement the necessary changes, particularly if they are working part-time.

Response: We appreciate the concerns expressed by the commenter and note that all MIPS eligible clinicians (as defined in section 1861(r) of the Act) practicing either full-time or part-time are required to participate in MIPS unless determined eligible for an exclusion. A MIPS eligible clinician, whether practicing full-time or part-time, who does not exceed the low-volume threshold would be excluded from participating in MIPS.

After consideration of the public comments we received, we are finalizing a modification to our proposal to define MIPS eligible clinicians or groups who do not exceed the low-volume threshold. At § 414.1305, we are defining MIPS eligible clinicians or groups who do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the low-volume threshold determination period, has Medicare Part B billing charges less than or equal to $30,000 or provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. We are finalizing our proposed policy at § 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 with respect to a year. The low-volume threshold also applies to MIPS eligible clinicians who practice in APMs under the APM scoring standard at the APM Entity level, in which APM Entities that do not exceed the low-volume threshold would be excluded from the MIPS requirements and not subject to a MIPS payment adjustment. Such an exclusion will not affect an APM Entity's QP determination if the APM Entity is an Advanced APM. Additionally, because we agree that it would be beneficial for individual eligible clinicians and groups to know whether they are excluded under the low-volume threshold prior to the start of the performance period, we are finalizing a modification to our proposal to allow us to make eligibility determinations regarding low-volume status using historical data. This modification will allow us to inform individual MIPS eligible clinicians and groups of their low-volume status prior to the performance period. We establish the low-volume threshold determination period to refer to the timeframe used to assess claims data for making eligibility determinations for the low-volume threshold exclusion. We define the low-volume threshold determination period to mean a 24-month assessment period, which includes a two-segment analysis of claims data during an initial 12-month period prior to the performance period followed by another 12-month period during the performance period. In order to conduct an analysis of the data prior to the performance period, we are establishing an initial low-volume threshold determination period consisting of 12 months. The initial 12-month segment of the low-volume threshold determination period would span from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and include a 60-day claims run out, which will allow us to inform eligible clinicians and groups of their low-volume status during the month (December) prior to the start of the performance period. The second 12-month segment of the low-volume threshold determination period would span from the last 4 months of a calendar year 1 year prior to the performance period followed by the first 8 months of the performance period in the next calendar year and include a 60-day claims run out, which will allow us to inform additional eligible clinicians and groups of their low-volume status during the performance period.

Thus, for purposes of the 2019 MIPS payment adjustment, we will initially identify the low-volume status of individual eligible clinicians and groups based on 12 months of data starting from September 1, 2015 to August 31, 2016. In order to account for the identification of additional individual eligible clinicians and groups that do not exceed the low-volume threshold during the 2017 performance period, we will conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2016 to August 31, 2017. For example, eligible clinicians who may have exceeded the low-volume threshold during the first determination assessment, but fall below the threshold during the performance period because their practice changed significantly, they changed practices from a prior year, etc. Similarly, for future years, we will conduct an initial eligibility determination analysis based on 12 months of data (consisting of the last 4 months of the calendar year 2 years prior to the performance period and the first 8 months of the calendar year prior to the performance period) to determine the low-volume status of individual eligible clinicians and groups, and conduct another eligibility determination analysis based on 12 months of data (consisting of the last 4 months of the calendar year prior to the performance period and the first 8 months of the performance period) to determine the low-volume status of additional individual MIPS eligible clinicians and groups. We will not change the low-volume status of any individual eligible clinician or group identified as not exceeding the low-volume threshold during the first eligibility determination analysis based on the second eligibility determination analysis. Thus, an individual eligible clinician or group that is identified as not exceeding the low-volume threshold during the first eligibility determination analysis will continue to be excluded from MIPS for the duration of the performance period regardless of the results of the second eligibility determination analysis. We will conduct the second eligibility determination analysis to account for the identification of additional, previously unidentified individual eligible clinicians and groups who do not exceed the low-volume threshold.

We recognize that the low-volume threshold determination period effectively combines two 12-month segments from 2 consecutive calendar years, in which the two 12-month periods of data that would be used for our analysis will not align with the calendar years. Also, we note that the low-volume threshold determination period may impact new Medicare-enrolled eligible clinicians who are excluded from MIPS participation for the performance period in which they are identified as new Medicare-enrolled eligible clinicians. Such clinicians would ordinarily begin participating in MIPS in the subsequent year, but under our modified low-volume threshold, are more likely to be excluded for a second year. The low-volume threshold exclusion may apply if, for example, such eligible clinician became a new Medicare-enrolled eligible clinician during the last 4 months of the calendar year and did not exceed the low-volume threshold of billed Medicare Part B allowed charges. Since the initial eligibility determination period consists of the last 4 months of the calendar year 2 years prior to the performance period Start Printed Page 77070and the first 8 months of the calendar year prior to the performance period, these new Medicare-enrolled eligible clinicians could be identified as having a low-volume status if the analysis reflects billed Medicare Part B allowed charges less than $30,000 or the provided care for 100 or fewer Part B-enrolled Medicare beneficiaries. As noted above, we will not change the low-volume status of any individual MIPS eligible clinician or group identified as not exceeding the low-volume threshold during the first eligibility determination analysis based on the second eligibility determination analysis.

d. Group Reporting

(1) Background

As noted in section II.E.1.e. of the proposed rule (81 FR 28176), section 1848(q)(1)(D) of the Act, requires the Secretary to establish and apply a process that includes features of the PQRS group practice reporting option (GPRO) established under section 1848(m)(3)(C) of the Act for MIPS eligible clinicians in a group for the purpose of assessing performance in the quality category and gives the Secretary the discretion to do so for the other performance categories. The process established for purposes of MIPS must, to the extent practicable, reflect the range of items and services furnished by the MIPS eligible clinicians in the group. We believe this means that the process established for purposes of MIPS should, to the extent practicable, encompass elements that enable MIPS eligible clinicians in a group to meet reporting requirements that reflect the range of items and services furnished by the MIPS eligible clinicians in the group. At § 414.1310(e), we proposed requirements for groups. For purposes of section 1848(q)(1)(D) of the Act, at § 414.1310(e)(1) we proposed the following way for individual MIPS eligible clinicians to have their performance assessed as a group: As part of a single TIN associated with two or more MIPS eligible clinicians, as identified by a NPI, that have their Medicare billing rights reassigned to the TIN (as discussed further in section II.E.2.b. of the proposed rule).

To have its performance assessed as a group, at § 414.1310(e)(2), we proposed a group must meet the proposed definition of a group at all times during the performance period for the MIPS payment year. Additionally, at § 414.1310(e)(3) we proposed in order to have their performance assessed as a group, individual MIPS eligible clinicians within a group must aggregate their performance data across the TIN. At § 414.1310(e)(3), we proposed that a group electing to have its performance assessed as a group would be assessed as a group across all four MIPS performance categories. For example, if a group submits data for the quality performance category as a group, CMS would assess them as a group for the remaining three performance categories. We solicited public comments on the proposal regarding how groups will be assessed under MIPS.

The following is a summary of the comments we received regarding our proposed requirements for groups, including: Individual MIPS eligible clinicians would have their performance assessed as a group as part of a single TIN associated with two or more MIPS eligible clinicians, as identified by a NPI, that have their Medicare billing rights reassigned to the TIN; a group must meet the definition of a group at all times during the performance period for the MIPS payment year; individual MIPS eligible clinicians within a group must aggregate their performance data across the TIN in order for their performance to be assessed as a group; and a group that elects to have its performance assessed as a group would be assessed as a group across all four MIPS performance categories.

Comment: The majority of commenters were supportive of the proposed group requirements. In particular, several commenters supported our proposal to allow MIPS eligible clinicians to report across the four performance categories at an individual or group level. The commenters also expressed support for the way in which we would assess group performance.

Response: We appreciate the support from commenters.

Comment: One commenter supported CMS' recognition that MIPS eligible clinicians may practice in multiple settings and proposal to allow such MIPS eligible clinicians to be measured as individuals or through a group's performance.

Response: We appreciate the support from the commenter.

Comment: A few commenters recommended that CMS consider allowing for greater flexibility in the reporting requirements and allow MIPS eligible clinicians to participate either individually or as a group for each of the four performance categories, as it may be reasonable to report individually for some categories and as a group for other categories. One commenter indicated that reporting for the advancing care information measures via a group would be a helpful option, but there are hurdles clinicians and health IT vendors and developers may need to overcome during the first 2 years to do so.

Response: We appreciate the feedback from the commenters. While we want to ensure that there is as much flexibility as possible within the MIPS program, we believe it is important that MIPS eligible clinicians choose how they will participate in MIPS as a whole, either as an individual or as a group. Whether MIPS eligible clinicians participate in MIPS as an individual or group, it is critical for us to assess the performance of individual MIPS eligible clinicians or groups across the four performance categories collectively as either an individual or group in order for the final score to reflect performance at a true individual or group level and to ensure the comparability of data. Section II.E.5.g.(5)(c) of this final rule with comment period describes group reporting requirements pertaining to the advancing care information performance category.

Comment: A few commenters indicated that group reporting can be challenging if the group includes part-time clinicians.

Response: We recognize that group-level reporting offers different advantages and disadvantages to different practices and therefore, it may not be the best option for all MIPS eligible clinicians who are part of a particular group. Depending on the composition of a group, which may include part-time clinicians, some groups may find meeting the MIPS requirements to be less burdensome if they report at the individual level rather than at the group level. Also, we note that some part-time clinicians may be excluded from MIPS participation at the individual level if they do not exceed the low-volume threshold (section II.E.3.c. of this final rule with comment period describes the low-volume threshold exclusion).

Comment: One commenter requested clarification regarding whether or not clinicians excluded from MIPS would also be excluded from group-level reporting.

Response: With clinician practices having the option to report at the individual (TIN/NPI) or group level (TIN), we elaborate on how a MIPS group's (TIN) performance is assessed and scored at the group level and how the MIPS payment adjustment is applied at the group level when a group includes clinicians who are excluded from MIPS at the individual level. We note that there are three types of MIPS exclusions: New Medicare-enrolled eligible clinicians, QPs and Partial QPs Start Printed Page 77071who do not report on applicable MIPS measures and activities, and eligible clinicians who do not exceed the low-volume threshold (see section II.E.3. of this final rule with comment period), which determine when an eligible clinician is not considered a MIPS eligible clinician and thus, not required to participate in MIPS. The two types of exclusions pertaining to new Medicare-enrolled eligible clinicians, and QPs and Partial QPs who do not report on applicable MIPS measures and activities are determined at the individual (NPI) level while the low-volume threshold exclusion is determined at the individual (TIN/NPI) level for individual reporting and at the group (TIN) level for group reporting.

A group electing to submit data at the group level would have its performance assessed and scored across the TIN, which could include items and services furnished by individual NPIs within the TIN who are not required to participate in MIPS. For example, excluded eligible clinicians (new Medicare-enrolled, QPs, or Partial QPs who do not report on applicable MIPS measures and activities, and do not exceed the low-volume threshold) are part of the group, and therefore, would be considered in the group's score. However, the MIPS payment adjustment would apply differently at the group level in relation to each exclusion circumstance. For example, groups reporting at the group level that include new Medicare-enrolled eligible clinicians, or QPs or Partial QPs would have the MIPS payment adjustment only apply to the Medicare Part B allowed charges pertaining to the group's MIPS eligible clinicians and the MIPS payment adjustment would not apply to such clinicians excluded from MIPS based on these two types of exclusions. We reiterate that any individual (NPI) excluded from MIPS because they are identified as new Medicare-enrolled, QP, or Partial QP would not receive a MIPS payment adjustment, regardless of their MIPS participation.

We note that the low-volume threshold is different from the other two exclusions in that it is not determined solely based on the individual NPI status, it is based on both the TIN/NPI (to determine an exclusion at the individual level) and TIN (to determine an exclusion at the group level) status. In regard to group-level reporting, the group, as a whole, is assessed to determine if the group (TIN) exceeds the low-volume threshold. Thus, eligible clinicians (TIN/NPI) who do not exceed the low-volume threshold at the individual reporting level and would otherwise be excluded from MIPS participation at the individual level, would be required to participate in MIPS at the group level if such eligible clinicians are part of a group reporting at the group level that exceeds the low-volume threshold.

We considered aligning how the MIPS exclusions would be applied at the group level for each of the three exclusion circumstances. We recognize that alignment would provide a uniform application across the three exclusions and offer simplicity, but we also believe it is critical to ensure that there are opportunities encouraging coordination, teamwork, and shared responsibility within groups. In order to encourage coordination, teamwork, and shared responsibility at the group level, we will assess the low-volume threshold so that all clinicians within the group have the same status: All clinicians collectively exceed the low-volume threshold or they do not exceed the low-volume threshold.

In addition, we recognize that individual clinicians who do not meet the definition of a MIPS eligible clinician during the first 2 years of MIPS such as physical and occupational therapists, clinical social workers, and others are not MIPS eligible. Thus, such clinicians are not required to participate in MIPS, but may voluntarily report measures and activities for MIPS. For those clinicians not MIPS eligible who voluntarily report for MIPS, they would not receive a MIPS payment adjustment. Accordingly, groups reporting at the group level may voluntarily include such eligible clinicians in its aggregated data that would be reported for measure and activities under MIPS. For groups reporting at the group level that voluntarily include eligible clinicians who do not meet the definition of a MIPS eligible clinician, they would have their performance assessed and scored across the TIN, but those clinicians would not receive a MIPS payment adjustment, regardless of their MIPS voluntary participation. We further note that these clinicians who are not eligible for MIPS, but volunteer to report, would not receive a MIPS payment adjustment.

We are finalizing our proposals regarding group requirements; however, we welcome additional comment on: How we are applying the application of group-related policies pertaining to group-level performance assessment and scoring and the MIPS payment adjustment to groups with eligible clinicians excluded from MIPS based on the three exclusions or not MIPS eligible for the first 2 years of MIPS; the advantages and disadvantages of how we are applying the application of group-related policies when groups include eligible clinicians excluded from the requirement to participate in MIPS at the individual level; and alternative approaches that could be considered.

Comment: One commenter expressed concerns that group reporting benchmarks and comparison groups have not yet been identified.

Response: All MIPS eligible clinicians, regardless of specialty, geographic location, or whether they report as an individual or group, who submit data using the same submission mechanism would be included in the same benchmark. We refer readers to sections II.E.6.a.(2)(a) and II.E.6.a.(3)(a) of this final rule with comment period for further discussion of policies regarding quality measure and cost measure benchmarks under MIPS.

Comment: One commenter requested clarification regarding group reporting for organizations with multiple practices/specialties.

Response: As proposed, group reporting would occur and be aggregated at the TIN level. No distinct reporting occurs at the specialty or practice site level.

Comment: One commenter requested clarification on what can be expected under MIPS by small practices for which measures are not applicable.

Response: In section II.E.6.b.(2)(b) of this final rule with comment period, we describe our scoring methodology that is applied when there are a few or no applicable measures under the quality performance category for MIPS eligible clinicians or groups to report.

Comment: One commenter recommended that CMS focus regulations on large systems and practices and have fewer regulations for small practices.

Response: We believe that it is essential for our requirements pertaining to group-level reporting should be applicable to all groups regardless of size, geographic location, composition, or other differentiating factors. However, we believe that there are circumstances in which our policies should consider how different types of groups would be affected. In this final rule with comment period, we establish an exclusion for individual MIPS eligible clinicians and groups who do not exceed a low-volume threshold pertaining to a dollar value of Medicare Part B allowed charges or a Part B-enrolled beneficiary count. Also, we finalize our proposal relating to MIPS eligible clinicians practicing RHCs and FQHCs, in which services rendered by an eligible clinician that are payable under the RHC or FQHC methodology Start Printed Page 77072would not be subject to the MIPS payments adjustments.

After consideration of the public comments we received, we are finalizing a modification to the following proposed policy:

  • Individual MIPS eligible clinicians who choose to report as a group will have their performance assessed as part of a single TIN associated with two or more eligible clinicians (including at least one MIPS eligible clinician), as identified by a NPI, that have their Medicare billing rights reassigned to the TIN (§ 414.1310(e)(1)).

In addition, we are finalizing the following policies:

  • A group must meet the definition of a group at all times during the performance period for the MIPS payment year in order to have its performance to be assessed as a group (§ 414.1310(e)(2)).
  • Eligible clinicians and MIPS eligible clinicians within a group must aggregate their performance data across the TIN in order for their performance to be assessed as a group (§ 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 (§ 414.1310(e)(4)).

(2) Registration

Under the PQRS, groups are required to complete a registration process to participate in PQRS as a group. During the implementation and administration of PQRS, we received feedback from stakeholders regarding the registration process for the various methods available for data submission. Stakeholders indicated that the registration process was burdensome and confusing. Additionally, we discovered that during the registration process when groups are required to select their group submission mechanism, groups sometimes selected the option not applicable to their group, which has created issues surrounding the mismatch of data. Unreconciled data mismatching can impact the quality of data. To address this issue, we proposed to eliminate a registration process for groups submitting data using third party entities. When groups submit data utilizing third party entities, such as a qualified registry, QCDR, or EHR, we are able to obtain group information from the third party entity and discern whether the data submitted represents group submission or individual submission once the data are submitted.

At § 414.1310(e)(5), we proposed that a group must adhere to an election process established and required by CMS, as described in this section. We did not propose to require groups to register to have their performance assessed as a group except for groups submitting data on performance measures via participation in the CMS Web Interface or groups electing to report the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey for the quality performance category as described further in section II.E.5.b. of the proposed rule. For all other data submission mechanisms, groups must work with appropriate third party entities to ensure the data submitted clearly indicates that the data represent a group submission rather than an individual submission. In order for groups to elect participation via the CMS Web Interface or administration of the CAHPS for MIPS survey, we proposed that such groups must register by June 30 of the applicable 12-month performance period (that is, June 30, 2017, for performance periods occurring in 2017). For the criteria regarding group reporting applicable to the four MIPS performance categories, see section II.E.5.a. of the proposed rule.

The following is a summary of the comments we received regarding our proposal that requires a group participating via the CMS Web Interface or electing to administer the CAHPS for MIPS survey to adhere to an election process established and required by CMS.

Comment: Several commenters expressed support for CMS's effort to ease the registration burden by not requiring registration or an election process for groups other than those electing to use the CMS Web Interface or CAHPS for MIPS survey for reporting of the quality performance category.

Response: We appreciate the support from commenters regarding our proposal.

Comment: One commenter expressed concern that clinicians who attempt to use the CMS Web Interface will not know if they have patients who satisfy reporting requirements until they attempt to submit their data. The commenter did not support the registration process required in order to select the use of the CMS Web Interface as a submission mechanism. The commenter asked whether clinicians will be able to elect other options once registration for the CMS Web Interface closes.

Response: Similar to the process that has occurred in past years under the PQRS program, we intend to provide the beneficiary sample to the groups that have registered to participate via the CMS Web Interface approximately 1 month prior to the start of the submission period. The submission period for the CMS Web Interface will occur during an 8-week period following the close of the performance period that will begin no earlier than January 1 and end no later than March 31 (the specific start and end dates for the CMS Web Interface submission period will be published on the CMS Web site). This is the earliest the sample is available due to the timing required to establish and maintain an effective sample size.

We encourage groups to review the measure specifications for each data submission mechanism and select the data submission mechanism that applies best to the group prior to registering to participate via the CMS Web Interface. We want to note that groups can determine if they would have Medicare beneficiaries to report data on behalf of for the CMS Web Interface measures. Groups that register to use the CMS Web Interface prior to the registration deadline (June 30) can cancel their registration or change their selection to report at an individual or group level only during the timeframe before the close of registration.

After consideration of the public comments we received, we are finalizing the following policy:

  • A group must adhere to an election process established and required by CMS (§ 414.1310(e)(5)), which includes:

++ Groups will not be required to register to have their performance assessed as a group except for groups submitting data on performance measures via participation in the CMS Web Interface or groups electing to report the CAHPS for MIPS survey for the quality performance category. For all other data submission methods, groups must work with appropriate third party entities as necessary to ensure the data submitted clearly indicates that the data represent a group submission rather than an individual submission.

++ In order for groups to elect participation via the CMS Web Interface or administration of the CAHPS for MIPS survey, such groups must register by June 30 of the applicable performance period (that is, June 30, 2017, for performance periods occurring in 2017).

Additionally, for operational purposes, we are considering the establishment of a voluntary registration process, if technically feasible, for groups that intend to submit data on performance measures via a qualified registry, QCDR, or EHR, which will enable such groups to specify whether or not they intend to participate as a group and which submission Start Printed Page 77073mechanism (qualified registry, QCDR, or EHR) they plan to use for reporting data, and provide other applicable information pertaining to the TIN/NPIs. In order for groups to know which requirements apply to their group for data submission purposes in advance of the performance period or submission period, we want to establish a mechanism that would allow us to identify the data submission mechanism a group intends to use and notify groups of the applicable requirements they would need to meet for the performance year, if technically feasible. We believe it is essential for groups to be aware of their applicable requirements in advance and as a result, the only means that would allow us to inform groups is dependent on us receiving such information from groups through a voluntary registration process; otherwise, it is impossible to contact groups without knowing who they are or inform groups of applicable requirements without knowing whether or not a group intends to report at the group level and the data submission mechanism a group is planning to utilize. For groups that would not voluntarily register, we would only be able to identify such groups after the close of the submission period when data has been submitted. To address this operational facet, we are considering the establishment of a voluntary registration process similar to PQRS in that groups would make an election of a data submission mechanism; however, based on feedback we have received over the years from PQRS participants, the voluntary registration process under MIPS would not restrict group participation to the selected options, including individual- or group-level reporting or a selected data submission mechanism, made by groups during the voluntary registration process; groups would have the flexibility to modify how they participate in MIPS.

With the optional participation in a voluntary registration process, the assessment of a group's performance would not be impacted by whether or not a group elects to participate in voluntary registration. We note that if a group voluntarily registers, information provided by the group would be used to proactively inform MIPS eligible clinicians about the timeframe they would need to submit data, which would be provided to the group during the performance period. We intend to use the voluntary registration process as a means to provide additional educational materials that are targeted and tailored to such groups; and if technically feasible, provide such groups with access to additional toolkits. We believe it is important for groups to have such information in advance in order to prepare for the submission of data. Also, we note that the voluntary registration process differs from the registration process required for groups electing to submit data via the CMS Web Interface, such that groups registering on a voluntary basis would be able to opt out of group-level reporting and/or modify their associated settings such as the chosen submission mechanism at any time. The participation of a group in MIPS via a data submission mechanism other than the CMS Web Interface or a group electing to administer the CAHPS for MIPS survey would not be contingent upon engagement in the voluntary registration process. Whether or not a group elects to participate in voluntary registration, a group must meet all of the requirements pertaining to groups. We intend to issue further information regarding the voluntary registration process for groups in subregulatory guidance.

e. Virtual Groups

(1) Implementation

Section 1848(q)(5)(I) of the Act establishes the use of voluntary virtual groups for certain assessment purposes. The statute requires the establishment and implementation of a process that allows an individual MIPS eligible clinician or a group consisting of not more than 10 MIPS eligible clinicians to elect to form a virtual group with at least one other such individual MIPS eligible clinician or group of not more than 10 MIPS eligible clinicians for a performance period of a year. As determined in statute, individual MIPS eligible clinicians and groups forming virtual groups are required to make such election prior to the start of the applicable performance period under MIPS and cannot change their election during the performance period. As discussed in section II.E.4. of the proposed rule, we proposed that the performance period would be based on a calendar year.

As we assessed the timeline for the establishment and implementation of virtual groups and applicable election process and requirements for the first performance period under MIPS, we identified significant barriers regarding the development of a technological infrastructure required for successful implementation and the operationalization of such provisions that would negatively impact the execution of virtual groups as a conducive option for MIPS eligible clinicians or groups. The development of an electronic system before policies are finalized poses several risks, particularly relating to the impediments of completing and adequately testing the system before execution and assuring that any change in policy made during the rulemaking process are reflected in the system and operationalized accordingly. We believe that it would be exceedingly difficult to make a successful system to support the implementation of virtual groups, and given these factors, such implementation would compromise not only the integrity of the system, but the intent of the policies.

Additionally, we recognize that it would be impossible for us to develop an entire infrastructure for electronic transactions pertaining to an election process, reporting of data, and performance measurement before the start of the performance period beginning on January 1, 2017. Moreover, the actual implementation timeframe would be more condensed given that the development, testing, and execution of such a system would need to be completed months in advance of the beginning of the performance period in order to provide MIPS eligible clinicians and groups with an election period.

During the implementation and ongoing functionality of other programs such as PQRS, Medicare EHR Incentive Program, and VM, we received feedback from stakeholders regarding issues they encountered when submitting reportable data for these programs. With virtual groups as a new option, we want to minimize potential issues for end-users and implement a system that encourages and enables MIPS eligible clinicians and groups to participate in a virtual group. A web-based registration process, which would simplify and streamline the process for participation, is our preferred approach. Given the aforementioned dynamics discussed in this section, implementation for the CY 2017 performance period is infeasible as a result of the insufficient timeframe to develop a web-based registration process. We have assessed alternative approaches for the first year only, such as an email registration process, but believe that there are limitations and potential risks for numerous errors, such as submitted information being incomplete or not in the required format. A manual verification process would cause a significant delay in verifying registration due to the lack of an automated system to ensure the accuracy of the type of information submitted that is required for registration. We believe that an email registration process could become Start Printed Page 77074cumbersome and a burden for groups to pursue participation in a virtual group. Implementation of a web-based registration system for CY 2018 would provide the necessary time to establish and implement an election process and requirements applicable to virtual groups, and enable proper system development and operations. We intend to implement virtual groups for the CY 2018 performance period, and we intend to address all of the requirements pertaining to virtual groups in future rulemaking. We requested comments on factors we should consider regarding the establishment and implementation of virtual groups.

The following is a summary of the comments we received regarding our intention to implement virtual groups for the CY 2018 performance period and factors we should consider regarding the establishment and implementation of virtual groups.

Comment: Many commenters supported the development of virtual groups. Some commenters noted that virtual groups are needed because some patients require multidisciplinary care in and out of a hospital and practice.

Response: We appreciate the support from commenters.

Comment: Several commenters supported CMS' decision not to implement virtual groups in year 1 in order to allow for the successful technological infrastructure development and implementation of virtual groups, but requested that CMS outline the criteria and requirements regarding the execution of virtual groups as soon as possible. Several commenters recommended that CMS use year 1 to develop the much-needed guidance and assistance that outlines the steps groups would need to take in forming virtual groups, such as drafting written agreements and developing additional skills and tools.

Response: We appreciate the support from commenters regarding the delay in the implementation of virtual groups. We intend to utilize this time to work with the stakeholder community to further advance the framework for virtual groups.

Comment: Multiple commenters expressed concern that virtual groups would not be implemented in year 1 and requested that CMS operationalize the virtual group option immediately. A few commenters indicated that the delay would impact small and solo practices and rural clinicians. Some commenters requested that in the absence of the virtual group option, small and solo practices and rural clinicians should be eligible for positive payment adjustments, but exempt from any negative payment adjustment. The commenters stated that exempting these physicians from negative payment adjustments would better incentivize the pursuit of quality and performance improvement among solo and small practices. A few commenters recommended that all practices of 9 or fewer physicians be exempt from MIPS or APM requirements until the virtual group option has been tested and is fully operational. One commenter suggested that as an alternative to delaying the implementation of virtual groups, CMS should allow virtual groups to report performance data on behalf of small practices and HPSAs for the CY 2017 performance period.

Response: As noted in the proposed rule, we identified significant barriers regarding the development of a technological infrastructure required for successful implementation and operationalization of the provisions pertaining to virtual groups. As a result, we believe that it would be technically infeasible to make a successful system to support the implementation of virtual groups for year 1. Also, we note that clinicians who are considered MIPS eligible clinicians are required to participate in MIPS unless they are eligible for one of the exclusions established in this final rule with comment period (see section II.E.3. of this final rule with comment period); thus, a MIPS eligible clinician participating in MIPS either as an individual or group will be subject to a payment adjustment whether it is positive, neutral, or negative. The Act does not provide discretion to only apply a payment adjustment when a MIPS eligible clinician receives a positive payment adjustment. In regard to the request to allow virtual groups to have an alternative function for year 1, we intend to implement virtual groups in a manner consistent with the statute.

Comment: A few commenters recommended that CMS redirect funds from the $500 million set aside for bonus payments to top performers toward financing a “safe harbor” for solo and small practices and rural providers.

Response: This is not permissible by statute, as the $500 million is available only for MIPS eligible clinicians with a final score at or above the additional performance threshold.

Comment: Several commenters identified several factors CMS should consider as it develops further policies relating to virtual groups, including the following: Ensuring that virtual groups have shared accountability for performance improvement; limiting the submission mechanisms to those that require clinicians in the virtual group to collaborate on ongoing quality analysis and improvement; maintaining flexibility for factors being considered for virtual groups; implementing a virtual group pilot to be run prior to 2018 implementation; and hosting listening sessions to receive input and feedback on this option with specialty societies and other stakeholders. Several commenters requested that CMS avoid placing arbitrary limits on minimum or maximum size, geography proximity, or specialty of virtual groups, but allow virtual groups to determine group size, geographic affiliations, and group composition. One commenter encouraged CMS to explore broad options for virtual groups outside the norm of TIN/NPI grouping. However, a few commenters recommended that virtual groups be limited to practices of same or similar specialties or clinical standards. Another commenter requested more detail on the implementation of virtual groups.

A few commenters recommended the following minimum standards for members of a virtual group: Have mutual interest in quality improvement; care for similar populations; and be responsible for the impact of their decisions on the whole group. A few commenters suggested that virtual groups should not have their performance ratings compared to other virtual groups, but instead, virtual groups should have their performance ratings compared to their annual performance rating during the initial implementation of virtual groups given that each virtual group's clinicians and beneficiaries may have varying risk preventing a direct comparison.

Response: We appreciate the suggestions from the commenters and as a result of the recommendations, we are interested in obtaining further input from stakeholders regarding the types of provisions and elements that should be considered as we develop requirements applicable to virtual groups. Therefore, we are seeking additional comment on the following issues for future consideration: The advantages and disadvantages of establishing minimum standards, similar to those suggested by commenters as noted above; the types of standards could be established for members of a virtual group; the factors would need to be considered in establishing a set of standards; the advantages and disadvantages of requiring members of a virtual group to adhere to minimum standards; the types of factors or parameters could be considered in developing a virtual group framework to ensure that virtual groups would be able to effectively use Start Printed Page 77075their data for meaningful analytics; the advantages and disadvantages of forming a virtual group pilot in preparation for the development and implementation of virtual groups; the framework elements could be included to form a virtual group pilot.

As we develop requirements applicable to virtual groups, we will also consider the ways in which virtual groups will each have unique characteristic compositions and varying patient populations and how the performance of virtual groups will be assessed, scored, and compared. We are committed to pursuing the active engagement of the stakeholders throughout the process of establishing and implementing virtual groups.

Comment: Several commenters recognized the potential value of virtual groups to ease the burden of reporting under MIPS. Commenters recommended that CMS expand virtual groups to promote the adoption of activities that enhance care coordination and improve quality outcomes that are often out of reach for small practices due to limited resources; encourage virtual groups to establish shared clinical guidelines, promote clinician responsibility, and have the ability to track, analyze, and report performance results; and promote information-sharing and collaboration among its clinicians.

Response: We appreciate the suggestions from the commenters and as a result of the recommendations, we are interested in obtaining further input from stakeholders regarding the technical and operational elements and data analytics/metrics that should be considered as we develop requirements applicable to virtual groups. Therefore, we are seeking additional comment on the following issues for future consideration: The types of requirements that could be established for virtual groups to promote and enhance the coordination of care and improve the quality of care and health outcomes; and the parameters (for example, shared patient population), if any, could be established to ensure virtual groups have the flexibility to form any composition of virtual group permissible under the Act while accounting for virtual groups reporting on measures across the four performance categories that are collectively applicable to a virtual group given that the composition of virtual groups could have many differing forms. We believe that each MIPS eligible clinician who is part of a virtual group has a shared responsibility in the performance of the virtual group and the formation of a virtual group provides an opportunity for MIPS eligible clinicians to share and potentially streamline best practices.

Comment: One commenter requested clarification on what constitutes a virtual group and how virtual groups will be formed. The commenter recommended that performance for individual MIPS eligible clinicians in virtual groups should be based on specialty-specific measures. The commenter also recommended that, when assessing performance, CMS should develop sufficient risk adjustment mechanisms that ensure MIPS eligible clinicians are only scored on the components of care they have control over, and CMS should develop robust and appropriate attribution methods. Another commenter recommended that CMS require virtual groups to demonstrate a reliable mechanism for establishing patient attribution as well as the ability to report throughout the performance period.

Response: We will consider these suggestions as we develop requirements applicable to virtual groups in future rulemaking. In regard to the commenter's request for clarification regarding what constitutes a virtual group and how they are formed, we note that section 1848(q)(5)(I) of the Act requires the establishment and implementation of a process that allows an individual MIPS eligible clinician or a group consisting of not more than 10 MIPS eligible clinicians to elect to form a virtual group with at least one other such individual MIPS eligible clinician or group of not more than 10 MIPS eligible clinicians for a performance period of a year.

Comment: One commenter suggested that virtual groups could be organized similarly to the current PQRS GPRO, in which virtual groups would have the flexibility to select both quality and resources use measures once they are further developed.

Response: We want to clarify that there is no virtual group reporting or similar option under PQRS. We note that virtual groups are not a data submission mechanism. MIPS eligible clinicians would have the option to participate in MIPS as individual MIPS eligible clinicians, groups, or, following implementation, virtual groups.

Comment: One commenter recommended the use of third-party certifications to assist with emerging virtual groups. The commenter also suggested that CMS provide bonus points for clinicians that register as virtual groups, similar to electronic reporting of quality measures.

Response: We will consider these suggestions as we develop requirements for virtual groups in future rulemaking.

Comment: A few commenters encouraged CMS to assess many of the virtual group challenges associated with EHR technology. One commenter stated that most small independent clinician offices do not use the same EHR technology as their neighbors, and virtual groups would create reporting and measurement challenges, especially with respect to the advancing care information performance category; the commenter suggested that CMS provide attestation as an option.

Another commenter indicated that the implementation of virtual groups could be unsuccessful based on the following factors: There is no necessary consistency in the nomenclature and methods used by different health IT vendors and developers, which would prevent prospective virtual group members from correctly understanding the degree and nature of the differences in approaches regarding data collection and submission; any vendor-related issues would be combined in unpredictable ways within virtual groups, causing the datasets to not correspond categorically and having inconsistent properties among the datasets; there is the prospect of a mismatch of properties for virtual group members on assessed measures, where neither excellence nor laggardly work would be clearly visible; and there is a risk of a practice joining a virtual group with “free riders,” which would result in a churning of membership and a serious loss of year-to-year comparison capabilities. In order to address such issues, the commenter recommended that CMS develop a system that includes the capability for clinicians and groups to participate in a service similar to online dating service applications that would allow clinicians and groups to use self-identifying descriptors to select their true peers within similar CEHRT.

A few commenters requested clarification regarding the approved methods for submitting and aggregating disparate clinician data for virtual groups, and whether or not new clinicians should be included in virtual groups if they have not been part of the original TIN throughout the reporting year.

Response: We thank the commenters for providing suggestions and identifying potential health IT challenges virtual groups may encounter regarding the reporting and submission of data. As a result of the recommendations and identification of potential barriers, we are interested in Start Printed Page 77076obtaining further input from stakeholders on these issues as we establish provisions pertaining to virtual groups and build a technological infrastructure for the operationalization of virtual groups. Therefore, we are seeking comment on the following issues for future consideration: The factors virtual groups would need to consider and address in order for the reporting and submission of data to be streamlined in a manner that allows for categorization of datasets and comparison capabilities; the factors an individual clinician or small practice who are part of a virtual group would need to consider in order for their CEHRT to have interoperability with other CEHRT if part of a virtual group; the advantages and disadvantages of having members of a virtual group use one form of CEHRT; the potential barriers that may make it difficult for virtual groups to be prepared to have a collective, streamlined system to capture measure data; and the timeframe virtual groups would need in order to build a system or coordinate a systematic infrastructure that allows for a collective, streamlined capturing of measure data.

Comment: One commenter suggested having Virtual Integrated Clinical Networks (VICN) as an alternative type of delivery system within the Quality Payment Program. The commenter further indicated that the development of VICNs can lead to better patient care and lower costs by including only physicians and other clinicians who commit to value-based care at the outset. The commenter noted that in order to participate, clinicians would have to agree to work and practice in a value-based way, with transparency of patient satisfaction, clinical outcomes, and cost results.

Response: We will consider the suggestion as we develop the framework and requirements for virtual groups.

Comment: One commenter suggested that CMS change the name of virtual groups to virtual network since a group includes coordination of a wide range of physician and related ancillary services under one roof that is seamless to patients while the term “network” implies more of an alignment of multiple group practices and clinicians operating across the medical community for purposes of reporting in MIPS.

Response: We will consider the suggestion as we establish the branding for virtual groups.

Comment: Multiple commenters did not support virtual groups being limited to groups consisting of not more than 10 MIPS eligible clinicians to form a virtual group with at least one other MIPS eligible clinician or group of not more than 10 MIPS eligible clinicians.

Response: With regard to commenters not supporting the composition limit of virtual groups, we note that section 1848(q)(5)(I) of the Act requires the establishment and implementation of a process that allows an individual MIPS eligible clinician or a group consisting of not more than 10 MIPS eligible clinicians to elect to form a virtual group with at least one other such individual MIPS eligible clinician or group of not more than 10 MIPS eligible clinicians for a performance period of a year. Thus, we do not have the authority to modify this statutory provision.

Comment: A few commenters requested that CMS work with clinician communities as it establishes the framework for the virtual group option. Commenters recommended that CMS protect against antitrust issues that may arise regarding physician collaboration to recognize economies of scale. One commenter indicated that accreditation entities have experience with the Federal Trade Commission (FTC) rules related to clinically integrated networks formed to improve the quality and efficiency of care delivered to patients and that publicly vetted accreditation standards could guide the development of virtual groups in a manner that incentivizes sustainable growth as integrated networks capable of long-term success under value-based reimbursement.

Response: We will consider the recommendations provided as we develop requirements pertaining to virtual groups.

Comment: One commenter recommended that in future rulemaking, CMS create a unique identifier for virtual groups, allow multiple TINs and split TINs, avoid thresholds based on the number of patients treated, avoid restricting the number of participants in virtual groups, and avoid limitations on the number of virtual groups. Another commenter suggested that virtual groups should be reporting data at either the TIN level, NPI/TIN level, or APM level.

Response: We appreciate the recommendations from the commenters and as a result of the suggestions, we are interested in obtaining further input from stakeholders regarding a group identifier for virtual groups. Therefore, we are seeking additional comment for future consideration on the following: The advantages and disadvantages of creating a new identifier for virtual groups; and the potential options for establishing an identifier for virtual groups. We intend to explore this issue.

We thank the commenters for their input regarding our intention to implement virtual groups for the CY 2018 performance period and factors we should consider regarding the establishment and implementation of virtual groups. We intend to explore the types of requirements pertaining to virtual groups, including, but not limited to, defining a group identifier for virtual groups, establishing the reporting requirements for virtual groups, identifying the submission mechanisms available for virtual group participation, and establishing methodologies for how virtual group performance will be assessed and scored. In addition, during the CY 2017 performance period, we will be convening a user group of stakeholders to receive further input on the factors CMS should consider in establishing the requirements for virtual groups and identify mechanisms for the implementation of virtual groups in future years.

(2) Election Process

Section 1848(q)(5)(I)(iii)(I) of the Act provides that the election process must occur prior to the performance period and may not be changed during the performance period. We proposed to establish an election process that would end on June 30 of a calendar year preceding the applicable performance period. During the election process, we proposed that individual MIPS eligible clinicians and groups electing to be a virtual group would be required to register in order to submit reportable data. Virtual groups would be assessed across all four MIPS performance categories. In future rulemaking, we will address all elements relating to the election process and outline the criteria and requirements regarding the formation of virtual groups. We solicited public comments on this proposal.

The following is summary of the comments we received regarding our proposals that apply to virtual groups, including: The establishment of an election process that would end on June 30 of a calendar year preceding the applicable performance period; the requirement of individual MIPS eligible clinicians and groups electing to be a virtual group to register in order to submit reportable data; and the assessment of virtual groups across all four MIPS performance categories.

Comment: A few commenters requested that CMS reconsider the deadline by which virtual groups would be required to make an election to participate in MIPS. One commenter recommended that the deadline should be 90 days before the performance period as opposed to 6 months.Start Printed Page 77077

Response: We will consider the recommendations as we establish the election process for virtual groups.

Comment: One commenter indicated that a registration process for the virtual group option would be an unnecessary burden and recommended that registration by virtual groups should only be required if the group participates in MIPS via the CMS Web Interface. Another commenter expressed concern that without a manageable registration system for virtual groups, there would be too many loopholes, which would add confusion to the program.

Response: We appreciate the commenters providing recommendations and we will consider the recommendations as we establish the virtual group registration process.

After consideration of the public comments we received, and with the delay of virtual group implementation, we are not finalizing our proposal to establish a virtual group election process that would end on June 30 for the CY 2017 performance period; the proposed requirement of individual MIPS eligible clinicians and groups electing to be a virtual group to register in order to submit reportable data; or the proposed assessment of virtual groups across all four MIPS performance categories.

4. MIPS Performance Period

MIPS incorporates many of the requirements of several programs into a single, comprehensive program. This consolidation includes key policy goals as common themes across multiple categories such as quality improvement, patient and family engagement, and care coordination through interoperable health information exchange. However, each of these legacy programs included different eligibility requirements, reporting periods, and systems for clinicians seeking to participate. This means that we must balance potential impacts of changes to systems and technical requirements to successfully synchronize reporting, as noted in the discussion regarding the definition of a MIPS eligible clinician in the proposed rule (81 FR 28173). We must take operational feasibility, systems impacts, and education and outreach on participation into account in developing technical requirements for participation. One area where this is particularly important is in the definition of a performance period.

MIPS applies to payments for items and services furnished on or after January 1, 2019. Section 1848(q)(4) of the Act requires the Secretary to establish a performance period (or periods) for a year (beginning with 2019). Such performance period (or periods) must begin and end prior to such year and be as close as possible to such year. In addition, section 1848(q)(7) of the Act provides that, not later than 30 days prior to January 1 of the applicable year, the Secretary must make available to each MIPS eligible clinician the MIPS adjustment (and, as applicable, the additional MIPS adjustment) applicable to the MIPS eligible clinician for items and services furnished by the MIPS eligible clinician during the year.

We considered various factors when developing the policy for the MIPS performance period. Stakeholders have stated that having a performance period as close to when payments are adjusted is beneficial, even if such period would be less than a year. We have also received feedback from stakeholders that they prefer having a 1 year performance period and have further suggested that the performance period start during the calendar year (for example, having the performance period occurring from July 1 through June 30). We additionally considered operational factors, such as that a 1 year performance period may be beneficial for all four performance categories because many measures and activities cannot be reported in a shorter time frame. We also considered that data submission activities and claims for items and services furnished during the 1 year performance period (which could be used for claims- or administrative claims-based quality or cost measures) may not be fully processed until the following year.

These circumstances will require adequate lead time to collect performance data, assess performance, and compute the MIPS adjustment so the applicable MIPS adjustment can be made available to each MIPS eligible clinician at least 30 days prior to when the MIPS payment adjustment is applied each year. For 2019, these actions will occur during 2018. In other payment systems, we have used claims that are processed within a specified time period after the end of the performance period, such as 60 or 90 days, for assessment of performance and application of the MIPS payment adjustment. For MIPS, we proposed at § 414.1325(g)(2) to use claims that are processed within 90 days, if operationally feasible, after the end of the performance period for purposes of assessing performance and computing the MIPS payment adjustment. We proposed that if we determined that it is not operationally feasible to have a claims data run-out for the 90-day timeframe, then we would utilize a 60-day duration in the calendar year immediately following the performance period.

This proposal does not affect the performance period per se, but rather the deadline by which claims for items and services furnished during the performance period need to be processed for those items and services to be included in our calculation. To the extent that claims are used for submitting data on MIPS measures and activities to us, such claims would have to be processed by no later than 90 days after the end of the applicable performance period, in order for information on the claims to be included in our calculations. As noted in this section, if we determined that it is not operationally feasible to have a claims data run-out for the 90-day timeframe, then we would utilize a 60-day duration. As an alternative to our proposal, we also considered using claims that are paid within 60 days after 2017, for assessment of performance and application of the MIPS payment adjustment for 2019. We solicited comments on both approaches.

Given the need to collect and process information, we proposed at § 414.1320 that for 2019 and subsequent years, the performance period under MIPS would be the calendar year (January 1 through December 31) 2 years prior to the year in which the MIPS adjustment is applied. For example, the performance period for the 2019 MIPS adjustment would be the full CY 2017, that is, January 1, 2017 through December 31, 2017. We proposed to use the 2017 performance year for the 2019 MIPS payment adjustment consistent with other CMS programs. This approach allows for a full year of measurement and sufficient time to base adjustments on complete and accurate information.

For individual MIPS eligible clinicians and groups with less than 12 months of performance data to report, such as when a MIPS eligible clinician switches practices during the performance period or when a MIPS eligible clinician may have stopped practicing for some portion of the performance period (for example, a MIPS eligible clinician who is on family leave, or has an illness), we proposed that the individual MIPS eligible clinician or group would be required to report all performance data available from the performance period. Specifically, if a MIPS eligible clinician is reporting as an individual, they would report all partial year performance data. Alternatively, if the MIPS eligible clinician is reporting with a group, then the group would report all Start Printed Page 77078performance data available from the performance period, including partial year performance data available for the individual MIPS eligible clinician.

Under this approach, MIPS eligible clinicians with partial year performance data could achieve a positive, neutral, or negative MIPS adjustment based on their performance data. We proposed this approach to incentivize accountability for all performance during the performance period. We also believe these policies would help minimize the impact of partial year data. First, MIPS eligible clinicians with volume below the low-volume threshold would be excluded from any MIPS payment adjustments. Second, MIPS eligible clinicians who report measures, yet have insufficient sample size, would not be scored on those measures and activities. Refer to section II.E.6. of this final rule with comment period for more information on scoring.

To potentially refine this proposal in future years, we solicited comments on methods to accurately identify MIPS eligible clinicians with less than a 12-month reporting period, notwithstanding common and expected absences due to illness, vacation, or holiday leave. Reliable identification of these MIPS eligible clinicians would allow us to analyze the characteristics of MIPS eligible clinicians' patient population and better understand how a reduced reporting period impacts performance.

We also solicited public comment on an alternative approach for future years for assessment of individual MIPS eligible clinicians with less than 12 months of performance data in the performance year. For example, if we can identify such MIPS eligible clinicians and confirm there are data issues that led to invalid performance calculations, then we could score the MIPS eligible clinician with a final score equal to the performance threshold, which would result in a zero MIPS payment adjustment. We note this approach would not assess a MIPS eligible clinicians' performance for partial-year performance data. We do not believe that consideration of partial year performance is necessary for assessment of groups, which should have adequate coverage across MIPS eligible clinicians to provide valid performance calculations.

We also solicited comment on reasonable thresholds for considering performance that is less than 12 months. For example, we expect that some MIPS eligible clinicians will take leave related to illness, vacation, and holidays. We would not anticipate applying special policies for lack of performance related to these common and expected absences assuming MIPS eligible clinicians' quality reporting includes measures with sufficient sample size to generate valid and reliable scores. We solicited comment on how to account for MIPS eligible clinicians with extended leave that may affect measure sample size.

We solicited comments on these proposals and approaches. The following is summary of the comments we received regarding our proposals for the MIPS performance period.

Comment: Numerous commenters believed that the first MIPS performance period should be delayed or treated as a transition year. The commenters stated that the proposed timeline for implementation was too compressed, unrealistic, and aggressive. They cited numerous educational and readiness factors for the recommended delay including: Time needed for stakeholders to digest the final rule with comment period and engage in further education and to make the necessary modifications to their practices, not overly burden their systems with such a short implementation time, and time needed to establish the administrative and technological tools necessary to meet the reporting requirements. The commenters suggested numerous alternative start dates to allow what the commenters believed would be sufficient time for MIPS eligible clinicians to prepare for reporting, ranging from a 2-year delay in implementation, using CY 2018 as the initial assessment period for MIPS, a start date no less than 15 months between the adoption of the final rule with comment period and its implementation, a start date no earlier than July 1, 2017, and lastly a start date of April 1, 2017.

Response: We appreciate the suggestions and have examined the issues raised closely. We agree with the commenters that to ensure a successful implementation of the MIPS, providing MIPS eligible clinicians' additional time to prepare their practices for reporting under MIPS is needed. Therefore, we have decided to finalize a modification of our proposal for the performance period for the transition year of MIPS to provide flexibility to MIPS eligible clinicians as they familiarize themselves with MIPS requirements in 2017 while maintaining reliability. Therefore, we are finalizing at § 414.1320(a)(1) that for purposes of the 2019 MIPS payment year, the performance period for all performance categories and submission mechanisms except for the cost performance category and data for the quality performance category reported through the CMS Web Interface, for the CAHPS for MIPS survey, and for the all-cause hospital readmission measure, is a minimum of a continuous 90-day period within CY 2017, up to and including the full CY 2017 (January 1, 2017 through December 31, 2017). Thus, MIPS eligible clinicians will only need to report for a minimum of a continuous 90-day period within CY 2017, for the majority of the submission mechanisms. This 90-day period can occur anytime within CY 2017, so long as the 90-day period begins on or after January 1, 2017, and ends on or before December 31, 2017. We note that the continuous 90-day period is a minimum; MIPS eligible clinicians may elect to report data on more than a continuous 90-day period, including a period of up to the full 12 months of 2017. For groups that elect to utilize the CMS Web Interface or report the CAHPS for MIPS survey, we note that these submission mechanisms utilize certain assignment and sampling methodologies that are based on a 12-month performance period. In addition, administrative claims-based measures (this includes all of the cost measures and the all-cause hospital readmission measure), are based on attributed population using the 12-month period. Additionally, we are finalizing at § 414.1320(a)(2) that for purposes of the 2019 MIPS payment year, for data reported through the CMS Web Interface or the CAHPS for MIPS survey and administrative claims-based cost and quality measures, the performance period under MIPS is CY 2017 (January 1, 2017 through December 31, 2017). Please note that, unless otherwise stated, any reference in this final rule with comment period to the “CY 2017 performance period” is intended to be an inclusive reference to all performance periods occurring during CY 2017. More details on these submission mechanisms are covered in section II.E.5.a.2. of this final rule with comment period.

We believe the flexibilities we are providing in our modified proposal discussed above will provide time for stakeholders to engage in further education about the new requirements and make the necessary modifications to their practices to accommodate reporting under the MIPS. We note that the continuous 90-day period of time required for reporting can occur at any point within the CY 2017 performance period, up until and including October 2, 2017, which is the last date that the continuous 90-day period of time required for reporting can begin and end within the CY 2017 performance period.

For the second year under the MIPS, we are finalizing our proposal to require reporting and performance assessment Start Printed Page 77079for the full CY performance period for purposes of the quality and cost performance categories. Specifically, we are finalizing at § 414.1320(b)(1) that for the 2020 MIPS adjustment, for purposes of the quality and cost performance categories, the performance period is CY 2018 (January 1, 2018 through December 31, 2018). We do believe, however, that for the improvement activities and advancing care information performance categories, utilizing a continuous 90-day period that occurs during the 12-month MIPS performance period will assist MIPS eligible clinicians as they continue to familiarize themselves with the requirements under the MIPS. Additionally, to allow MIPS eligible clinicians and groups adequate time to transition to technology certified to the 2015 Edition for use in CY 2018, we believe it is appropriate to allow reporting on any continuous 90-day period that occurs during the 12-month MIPS performance period for the advancing care information performance category in CY 2018. Specifically, for the improvement activities and advancing care information performance categories, we are finalizing at § 414.1320(b)(2) that the performance period under MIPS is a minimum of a continuous 90-day period within CY 2018, up to and including the full CY 2018 (January 1, 2018 through December 31, 2018).

Comment: Other commenters suggested making 2018 the first performance period for the first payment year of 2019. They stated that MIPS eligible clinicians could receive more timely feedback on their performance and still have the opportunity to make improvements in the second half of 2017 before the first performance period would begin.

Response: It is not technically feasible to establish the first performance period in 2018 and begin applying MIPS payment adjustments in 2019. Some of the factors involved include: Allowing for a data submission period that occurs after the close of the performance period, running our calculation and scoring engines to calculate performance category scores and final score, allowing for a targeted review period, establishing and maintaining budget neutrality and issuance of each MIPS eligible clinician's specific MIPS payment adjustment. Based on our experience under the PQRS, VM, and Medicare EHR Incentive Program for Eligible Professionals, all of these activities on average take upwards of 9-12 months. We will continue to examine these operational processes to add efficiencies and reduce this timeframe in future years.

Comment: Other commenters noted that MIPS eligible clinicians ideally require 18 to 24 months' time to adequately identify, adopt, and apply measures to established workflows for consistent data capture. The commenters also noted that most MIPS eligible clinicians are not yet comfortable with ICD-10 and added that there are 1491 new ICD-10 CM codes becoming effective in October 2016, and that MIPS eligible clinicians would not have sufficient time to refine processes within the proposed timeline (that is, by January 1, 2017).

Response: We are finalizing a modified CY 2017 performance period, as discussed above. We believe this will allow MIPS eligible clinicians to adequately identify, adopt, and apply measures to establish workflows for consistent data capture as they familiarize themselves with MIPS requirements in 2017. We appreciate the concern raised by the commenters on the introduction of the new ICD-10 codes. However, we note that there are numerous resources available to assist commenters on incorporating these codes into their workflows at https://www.cms.gov/​medicare/​Coding/​ICD10/​index.html.

Comment: Another commenter requested more time for clinicians and payers other than Medicare to make adjustments to programs and amend large numbers of significant risk‐based contracts between states and health plans, and between health plans and their network delivery system individual practice associations (IPAs), groups, and clinicians. The commenter stated that this would allow time for significant contract and subcontract amendments for other payers, and system changes for metrics, claims, and benefit systems.

Response: We believe the flexibilities we are providing in the first performance period, as discussed in this final rule with comment period, will allow MIPS eligible clinicians and third party intermediaries the time needed to update their systems to meet program requirements and amend any agreements as necessary.

Comment: Some commenters were concerned that setting the performance period too soon would not give third party intermediaries, such as EHR vendors, qualified registries, health IT vendors, and others the time needed to update their systems to meet program requirements. The commenters recommended setting the performance period later to allow these third party intermediaries time to validate new data entry and testing tools and overhaul their systems to comply with 2015 edition certification requirements. Another commenter believed the proposed policies would often require the use of multiple database systems that could not be accomplished in the time required.

Response: We agree with the commenters that ensuring that third party intermediaries have sufficient time to update their technologies and systems will be a key component of ensuring that MIPS eligible clinicians are ready to meet program requirements. We believe the flexibilities we are providing in the first performance period, as discussed in this final rule with comment period, will allow third party intermediaries the time needed to update their systems to support MIPS eligible clinician participation. We note that there are no new certification requirements required for the Quality Payment Program and many health IT vendors have already begun work toward the 2015 Edition certification criteria which were finalized in October 2015. We believe that the flexibility offered and the lead time to required use of technology certified to the 2015 Edition, will mitigate these concern; however, we intend to monitor health IT development progress, adoption and implementation, and the readiness of QCDRs, health IT vendors, and other third parties supporting MIPS eligible clinician participation.

Comment: Another commenter believed a later start date would provide CMS with more time to address several issues that were absent from the proposed rule, including the development of virtual groups, improved risk-adjustment and attribution methods, further refinement of episode-based resource measures and measurement tools and enhanced data feedback to participants. One commenter stated that they believed that the government programs that regulate and support MIPS have yet to be designed, tested, and implemented. The commenter stated they do not have MIPS performance thresholds or measure benchmark data and therefore cannot prepare their office to streamline the new processes and report appropriately in 2017.

Response: We respectfully disagree with the commenter and intend to address further refinements to the MIPS program in future years. We appreciate the commenter's desire to delay the start of the MIPS until we are able to have full implementation of these factors. However, as we have noted in other sections within this final rule with comment period we intend to implement these provisions when technically feasible, as in the case of Start Printed Page 77080virtual groups, and when available, as in the case of improved risk-adjustment and attribution methods as well as additional episode-based resource measures. Additionally, as noted in section II.E.10. of this final rule with comment period, we intend to provide feedback to participants as required by statute, and we will enhance these feedback efforts over time. Lastly, as indicated in section II.E.6.a. of this final rule with comment period, due to the additional factors we are incorporating to simplify our scoring methodology, we have published the MIPS performance threshold in this final rule with comment period, and we will publish the measure benchmarks where available prior to the beginning of the performance period.

Comment: Several commenters recommended that the first performance period occur later than January 1, 2017 based on commenters' analysis of the MACRA statute. Some commenters believe a delayed start date of July 1, 2017 would better match Congressional intent that the performance period be as close to the MIPS payment adjustment period as possible, while still allowing for the related MIPS payment adjustments to take place in 2019. The commenters further recommended that CMS use the time between the publication of the final rule with comment period and a delayed performance period start date to test and refine the performance feedback mechanisms for the Quality Payment Program. The commenters stated that by including the “as close as possible” language in section 1848(q)(4) of the Act, the Congress sought to urge CMS to select a performance period that will close the gap on CMS's practice of setting a 2-year look-back period for Medicare quality programs.

Response: We appreciate the commenters concerns about Congressional intent for having a performance period as close as possible to the related MIPS payment adjustments. However, we believe our proposal is consistent with section 1848(q)(4) of the Act, as a performance period that occurs 2 years prior to the payment year is as close to the payment year as is currently possible. As noted above, from our experiences under the PQRS, VM, and Medicare EHR Incentive Program for Eligible Professionals, it takes approximately 9-12 months to perform the operational processes to produce a comprehensive and accurate list of MIPS eligible clinicians to receive a MIPS payment adjustment. We will continue to assess this timeframe for efficiencies in the future.

Comment: Some commenters noted that section 1848(s) of the Act, as added by section 102 of MACRA, requires a quality measure development plan with annual progress reports, the first of which must be issued by May 1, 2017. The commenters stated that by starting the Quality Payment Program on January 1, 2017, before the first annual progress report is finalized, CMS will not have finalized key program requirements before it begins MIPS.

Response: We note that the commenters are referring to 2 separate requirements under section 1848(s) of the Act. The quality measure development plan, known as the CMS Quality Measure Development Plan (MDP), was finalized and posted on May 2, 2016, which is available at https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Value-Based-Programs/​MACRA-MIPS-and-APMs/​Final-MDP.pdf and required to be updated as appropriate. In addition, the MDP Annual Report, which is to report on progress in developing measures, is required to be posted annually beginning not later than May 1, 2017. We intend to post the initial MDP Annual Report on May 1, 2017. While these statutory requirements are mandatory and support the development of the MIPS program, they are not prerequisites for the implementation of the MIPS program.

Comment: Several commenters stated that the performance period was too early and suggested that CMS create an initial transitional performance period or phase-in period for the MIPS program. These commenters recommended numerous modifications and advantages as part of the transitional or phase-in period including: Phasing in some of the performance requirements such as requiring fewer quality measures and/or improvement activities in the transition year, creation of gradual performance targets which would allow sufficient time for participants to adapt to data collection and reporting prior to increasing performance standards, and phasing in the MIPS adjustment amounts such as applying a maximum MIPS payment adjustment of 2 percent in the transition year of the program, or applying negative MIPS adjustments only to groups of MIPS eligible clinicians above a certain size. These commenters noted the advantages of a transitional or phase-in period include allowing CMS to offset its concerns around calculation of outcome and claims-based measures, the feasibility of using different reporting mechanisms, meeting statutory deadlines, postponing changes to the advancing care information performance category and the capability of CMS' internal processes.

The commenters suggested various dates for the transitional or phase-in period such as: January 1, 2017 through June 30, 2017, July 1, 2017 through December 31, 2017, allowing MIPS eligible clinicians to select a 6-month performance period or allowing MIPS eligible clinicians to use the full calendar year with an optional look-back to January 1 in 2017. The commenters requested that CMS provide technical assistance and a submission verification process during the transition period.

Response: We agree with the commenters that there are numerous advantages to having a transitional or phase-in period for the transition year. As indicated previously in this section of this final rule with comment period, we have modified the performance period for the transition year to occur for a minimum of one continuous 90-day period up to a full calendar year within CY 2017 for all data in a given performance category and submission mechanism. We believe that this modified performance period as well as the modifications we are making to our scoring methodology as reflected in section II.E.6. of this final rule with comment period address a number of the concerns the commenters have raised. Lastly, we note that section 1848(q)(6) of the Act requires us to apply the MIPS adjustment based on a linear sliding scale and an adjustment factor of an applicable percent, which the statute defines as 4 percent for 2019. We do not have the discretion to apply a smaller adjustment factor to MIPS eligible clinicians such as only 2 percent.

Comment: Multiple commenters recommended that 2017 be utilized for reporting purposes only and not payment purposes. Their recommendations ranged from having 2017 function as a straightforward reporting year only, such as an “implementation and benchmarking” year which would still allow CMS to collect data, but would not be used for financial impacts in 2019. Other suggestions included utilizing 2017 as a beta test year for MIPS eligible clinicians, plan capabilities and system preparedness. The commenters believed that a staged approach to MACRA implementation would provide for more coordinated change within the delivery system for patients, which must remain a focus for all as we continue embracing the Triple Aim of improving the patient experience of care (including quality Start Printed Page 77081and satisfaction); improving the health of populations; and reducing the per capita cost of health care. More information regarding the Triple Aim may be found at http://www.hhs.gov/​about/​strategic-plan/​strategic-goal-1/​.

Response: We would like to explain that MIPS is a program where payment adjustments must be applied based on each MIPS eligible clinician's total performance on measures and activities. As such, we are not able to apply MIPS payment adjustments based on reporting alone. Additionally, as we have discussed above, we have made modifications to the performance period for the transition year of MIPS, as well as to the scoring methodology, as discussed in section II.E.6. of this final rule with comment period to allow MIPS eligible clinicians the opportunity to gain experience under the program without negative payment consequences.

Comment: Other commenters urged changes to MIPS to provide flexibility for small practices. The commenters suggested a voluntary phase-in for small practices over a several-year period. Alternatively, the commenters suggested that CMS should not penalize very small practices (for example, five or fewer MIPS eligible clinicians) for a specified period of time, allowing them to implement and learn about MIPS reporting. Another commenter suggested that for the transition year of MIPS, CMS could permit small practices to be credited with full participation in MIPS based on a single quarter of successfully submitted 2017 data and permit larger practices to submit two quarters of data.

Response: We have provided considerable flexibility for small practices throughout our MIPS proposals and this final rule with comment period. Specifically, we believe our modified low-volume threshold policy, as discussed in section II.E.3.c. of this final rule with comment period, will provide small groups considerable flexibility that will address the commenters' concerns.

Comment: Some commenters were concerned with CMS statements from the proposed rule—specifically, that MIPS eligible clinicians do not have to begin reporting at the start of the performance period, suggesting that MIPS eligible clinicians will have more time to collect data, change workflows, and implement required MIPS and APM changes—create confusion as many of the MIPS program's quality measures require actions to be taken at the point of care and cannot be completed at a later date.

Response: Our comments from the proposed rule accurately reflected our proposed policies. We regret any confusion created by statements in the proposals. The commenters are correct that many quality measures are required to be reported for every encounter. It is also correct, however, that other quality measures do not require reporting of every encounter (that is, NQF 0043: Pneumonia Vaccination Status for Older Adults). In general, the performance period is a window of time to report measures and, depending on the measure, MIPS eligible clinicians may need to report for just one quarter and the specified number of encounters for a given measure, or may need multiple encounters in multiple quarters for other measures

Comment: Some commenters stated that the proposal interrupts their current short-term course of action of meeting Meaningful Use in 2016 and requested that we utilize 2017 as a preparation year to implement, adopt, measure, monitor, and manage new measures and boost performance on measures that previously had low thresholds for which MIPS eligible clinicians have to maximize performance.

Response: We note that for those MIPS eligible clinicians who have previously participated in the EHR Incentive Program, the measures and objectives that are required under the advancing care information performance category are a reduction in the number and types of measures as previously required. More information on the advancing care information performance category can be found in section II.E.5.g. of this final rule with comment period.

Comment: There were various comments regarding the duration of the MIPS performance period. Many commenters supported the 12-month performance period and requested that CMS stick to that timeline. The commenters stated that if timelines must be changed, CMS should do so before the performance period begins. Several commenters supported the performance period of one full year versus 90 days. They believed this would lead to consistent and high-quality data submission. Another commenter generally supported the proposed performance period but cautioned CMS that any shortened performance periods could burden certain MIPS eligible clinicians whose practices vary in volume based on factors such as their geographies, specialties, and nature of the patients they treat that are outside of their control. Other commenters believed CMS should not delay the Quality Payment Program implementation or finalize an abbreviated performance period in the transition year. These commenters suggested that CMS act immediately on the premise that implementation for 2017 should begin now with clear education and guidance in order to ensure successful transitions to the new Quality Payment Program.

Response: We appreciate the commenters' support. We believe that measuring performance on a 12-month period is the most accurate and reliable method for measuring a MIPS eligible clinician's performance. We note that we are modifying our proposal to require reporting for a minimum continuous 90-day period of time within the CY 2017 performance period for the majority of available submission mechanisms for all data in a given performance category and submission mechanism. However, we strongly encourage all MIPS eligible clinicians to submit data for up to the full calendar year if feasible for their practice. We anticipate that MIPS eligible clinicians who are able to submit a more robust data set, such as data on a 12-month period, will have the benefit of having their full population of patients measured, which will assist these MIPS eligible clinicians on their quality improvement goals.

Comment: Some commenters believed MACRA's four MIPS performance categories are adding complexity to the delivery of patient-centered care and do not increase the time medical clinicians spend with patients. Specifically, the commenters believed that there is not much of a difference between PQRS/MU and the new “quality” and “advancing care information” performance categories. The commenters added that the improvement activities performance category appears complicated and the cost performance category is intensive. The commenters proposed a solution that measurable elements be for a 90-day period during the calendar year so that measuring tools will not need to be in place at all times, resulting in less disruption and a greater focus on patients.

Response: Our intention in creating MIPS is to provide a more comprehensive and simplified system that provides value. The commenter is correct that we maintained many elements of the PQRS and EHR Incentive Program that we found through experience to be meaningful to clinicians. The requirements for the cost and improvement activities performance categories are described in sections II.E.5.e. and II.E.5.f., respectively, of this final rule with comment period. We believe these performance categories to be very low in burden. In addition, as Start Printed Page 77082described in section II.E.5.e of this final rule with comment period, the cost performance category will account for 0 percent of the final score in 2019 and we are redistributing the final score weight from cost performance category to the quality performance category. Lastly, as noted above, we are allowing MIPS eligible clinicians to report on quality, improvement activities, and advancing care information performance category information for a minimum of a continuous 90-day period during the CY 2017 performance period for the majority of available submission mechanisms for all data in a given performance category and submission mechanism. In addition, the cost performance category will be calculated based on the performance period using administrative claims data. As a result, individual MIPS eligible clinicians and groups will not be required to submit any additional information for the cost performance category.

Comment: Another commenter believed a full year of quality reporting is necessary to ensure data reliability for small practices but encouraged CMS to finalize a 90-day performance period for the improvement activities and advancing care information performance categories. The commenter believed CMS could finalize a shorter performance period for quality reporting in the future if 2015 data is modeled to show sufficient reliability under a shorter performance period.

Response: We agree with the commenter and believe that measuring performance on a 12-month period is the most accurate method for measuring a clinician's performance. However, for the transition year of MIPS, we are providing flexibility while maintaining reliability and finalizing a modified performance period, as discussed above, so that MIPS eligible clinicians may familiarize themselves with MIPS requirements.

Comment: Several commenters requested that CMS define the performance period as less than a full year. The suggestions of the start date were varied including: A suggested start date of July 1, 2017, which would allow MIPS eligible clinicians enough time to review and select appropriate measures; a 9-month performance period of April 1 through December 31, 2017; a 90 day period from January 1st through March 31st of each year because the commenter believed that this shorter time frame would not differ significantly from a full-year assessment period; and a period occurring from January 15 through April 15 so that reports could be compiled and tested prior to submission. These commenters cited various concerns, including that full calendar year reporting would be a significant departure from current reporting requirements under the EHR Incentive Program and that it would not allow for full validation and testing of EHR-generated data following software upgrades or measurement specification changes. Other commenters were concerned that the proposal to use a full calendar year for the performance period could create administrative burden for practices and limit innovation without improving the validity of the data. The commenters recommended that in future years, CMS take advantage of the flexibility granted under the MACRA statute to allow MIPS eligible clinicians to select a shorter performance period for either the MIPS program or APM incentive payments. Another commenter believed that CMS should permit MIPS eligible clinicians to select a shorter performance period if they believe it is more appropriate for their practice.

Response: We do understand and appreciate the concerns raised by commenters that the performance period for the transition year of the program may be a shorter length than 12 months. For the transition year of MIPS, we are providing flexibility while maintaining reliability and finalizing a modified performance period, as discussed above, so that MIPS eligible clinicians may familiarize themselves with MIPS requirements.

Comment: A few commenters noted that measures for the cost performance category may need to be calculated over a longer period of time in order to ensure their reliability and applicability to practices, and recommended that if CMS shortens the initial MIPS performance period, CMS should make a distinction between performance periods for performance categories where data submission is required versus those where CMS calculates measures using administrative claims data. The commenters suggested that CMS should conduct detailed analysis of VM data to determine the extent to which including data for a year rather than 6 or 9 months improves reliability and expands applicability of the measures.

Response: We appreciate the commenters' suggestions. We have not done an analysis to look at reliability of the measures using a 6-month or 9-month performance period. We will consider this approach for future rulemaking.

Comment: Another commenter recommended that CMS should also reduce the case minimums for measures as MIPS eligible clinicians will not have sufficient time to see the same number of patients during a shortened performance period.

Response: We refer the commenter to section II.E.6.a.(2) of this final rule with comment period where we discuss the quality scoring proposals and the case minimum requirements.

Comment: Other commenters recommended a 90-day performance period for 2017 for private specialty practices, as well as a 90-day performance period for any reporting year that the practice is required to upgrade their version of CEHRT. For example, the commenters noted that in mid-2017, many MIPS eligible clinicians will be upgrading from EHR technology certified to the 2014 Edition to EHR technology certified to the 2015 Edition. The commenters stated that this can often cause data integrity issues and would continuously place the practice on a split CEHRT any year that this type of upgrade occurs. They suggested a 90-day performance period during the upgrade year would allow a practice to upgrade and attest to the most recent version and standards.

Response: We are modifying our proposal to allow reporting for a minimum of a continuous 90-day period of time within the CY 2017 performance period for the majority of available submission mechanisms for all data in a given performance category and submission mechanism. Additionally, we understand the commenters' concerns and rationale for requesting a 90-day performance period. We note that for the first performance period in 2017, we will accept a minimum of 90 days of data within CY 2017, though we greatly encourage MIPS eligible clinicians to meet the full year performance period. In order to allow MIPS eligible clinicians and groups adequate time to transition to technology certified to the 2015 Edition for use in CY 2018, we believe it is appropriate to also allow a performance period of continuous 90-day period within the CY for the advancing care information performance category in CY 2018.

Comment: Another commenter requested that CMS offer advance notice appropriate to the size of the change (for example, transitioning to new editions of CEHRTs might require years of notice, whereas annually updated benchmarks might require only a few months). The commenter requested that the proposed policies not be implemented until at least 6 months after the final rule with comment period is published.

Response: We will provide as much advance notice as is necessary when Start Printed Page 77083making changes to the MIPS program. We recognize that all parties involved in the MIPS program require advance notice to make adjustments to accommodate changes.

Comment: Some commenters suggested that CMS shorten the performance period to 9 months of the calendar year, followed by 3 months of data analysis to calculate the scores and MIPS payment adjustments. The rationale for this recommendation included allowing for a number of program improvements, including reducing administrative burden in MIPS, aligning the performance period across categories, shrinking the 2-year lag period between performance and payment, and increased relevance and timeliness of feedback. The commenters also stated that this would give opportunity to set benchmarks based on more current data. Based on one commenter's polling of its members, 92 percent preferred a performance period of any 90 consecutive days compared to the proposed performance period.

Response: We considered utilizing a 9-month performance period as the commenter recommended, however we did not utilize this option since this would still require a “2-year lag” to account for the post submission processes of calculating the MIPS eligible clinician's final score, establishing budget neutrality and issuing the payment adjustment factors and allowing for a targeted review period to occur prior to the application of the MIPS payment adjustment to MIPS eligible clinicians claims. As stated above, we are modifying our proposal and finalizing that MIPS eligible clinicians will only need to report for a minimum of a continuous 90-day period in 2017, for the majority of the data submission mechanisms. We believe this flexibility will allow for a number of program improvements, including reducing administrative burden in MIPS for the transition year and will align across the quality, advancing care information, and improvement activities performance categories. In addition, we will continue working with stakeholders to improve feedback provisions under MIPS and to shorten the “2-year lag” that the commenter describes.

Comment: One commenter stated that they recognized a shorter performance period may present challenges for CMS systems and processes; therefore, they urged CMS to work with MIPS eligible clinicians to develop options and a specific plan to provide accommodations where possible.

Response: We appreciate the comment and will continue to work closely with stakeholders throughout the Quality Payment Program.

Comment: Other commenters believed a shorter performance period would eliminate the participation burden and confusion for MIPS eligible clinicians who may switch practices mid-year and have to track and report data for multiple TIN/NPI combinations under the proposed full calendar year performance period.

Response: We agree with the commenter that the shortened minimum continuous 90-day period of time will assist in decreasing participation burden. We note that the modified performance period will not eliminate the need for tracking multiple TIN/NPIs depending upon the specific circumstances of the MIPS eligible clinician, but we agree with the commenter that it will mitigate this issue.

Comment: A few commenters recommended a 6-month performance period for MIPS with an optional look-back period for registries to increase sample size, validity and reliability and an extension of data submissions for QCDRs to April 31 following the performance period, or 4 months after the performance period to allow for the capture and analytics required for the use of risk-adjusted outcomes data.

Response: Our modified proposal of a continuous 90-day period within the CY 2017 performance period for all data in a given performance category and submission mechanism is a minimum period and we strongly encourage all MIPS eligible clinicians to report on data for a full year where possible for their practice. We believe this policy will address the commenters' concerns while maintaining reliability. Our policies regarding the performance period are described in more detail in section II.E.4. of this final rule with comment period. We note that it is not clear how a longer data submission timeframe will help with the capture of risk-adjusted data elements used in outcomes measures. In most, if not all, instances, any co-morbidities affecting the outcome for a patient would be known before or at the time the care is rendered.

Comment: One commenter suggested that if CMS rejects changing the initial performance period for 2017 to 90 days, it should implement preliminary and f-Final performance periods, with analysis periods (from January to March) and implementation periods (from April to May), to allow MIPS eligible clinicians to evaluate their performance with the various MIPS requirements from August to September, followed by a final performance period from October to December.

Response: We thank the commenter for their feedback. As discussed above, we are modifying our proposal to allow reporting for a minimum of a continuous 90-day period within the CY 2017 performance period for the majority of available submission mechanisms for all data in a given performance category and submission mechanism.

Comment: Many commenters stated that CMS must work to reduce the 2-year gap between the performance period and the payment year because it is burdensome, is not meaningful nor actionable as MIPS eligible clinicians will not know what they must adjust to meet benchmarks, and it hinders timely data reporting and feedback. One commenter acknowledged the operational difficulty associated with having performance periods close to MIPS payment adjustment periods, but requested that CMS work to shorten the look back period between performance assessment and adjustment.

Response: We agree with commenters that improved feedback mechanisms are always important, and we will continue working with stakeholders to provide timely and better feedback under MIPS and to shorten the “2-year gap” that the commenter describes.

Comment: There were various suggestions on the most appropriate time gap between the performance period and the payment year. Several commenters suggested that a 1-year gap would be more appropriate and others proposed a 6-month time gap. Another commenter believed, that the time lag of essentially 2 years between the performance period and the payment year severely disadvantages MIPS eligible clinicians falling below the top tier performance threshold and inflates the rating of competing MIPS eligible clinicians, who can rest on the laurels of their prior performance years. Further, the commenter noted that if a MIPS eligible clinician had an unsatisfactory performance rating, (for example, from data collected in January of 2016), and took corrective action to earn a higher rating, the efforts of that corrective action would not be available to the public for a minimum of 2 years. A few commenters believed CMS should increase the relevance and timeliness of data, which could be provided on a quarterly basis.

Response: We appreciate the commenters' feedback. We agree with the commenters that a delay between the performance period and the MIPS payment adjustment year impacts the clinicians' ability to make timely Start Printed Page 77084improvements within their practice. For the initial years of MIPS, we do anticipate that this gap between the performance period and the payment adjustment year will continue to occur to allow time for submission and calculation of data, issuance of feedback, a targeted review period, calculation of final scores, and application of clinician-specific MIPS adjustments in time for the payment year.

Comment: Other commenters believed CMS should use language clarifying that the MIPS performance period begins on January 1, 2017. The commenters suggested linking the language for the performance year with the adjustment year in some way (for example, “MIPS 2017/19”, “2017 performance period (2019)”).

Response: We will ensure that all communications clearly indicate the link between the performance period and the MIPS payment adjustment year.

Comment: A few commenters expressed support for CMS' proposal of a 90-day claims data run-out. Another commenter stated that if the proposed window is not feasible, the commenter supported a 60-day window.

Response: We appreciate the commenter's feedback. Based on further analyses of Medicare Part B claims for 2014, we have determined that there is only a 0.5 percent difference in claims processing completeness when using 90 days rather than 60 days. Therefore, we are finalizing our alternative proposal at § 414.1325(f)(2) that the submission deadline for Medicare Part B claims, must be on claims with dates of service during the performance period that must be processed no later than 60 days following the close of the performance period.

Comment: Another commenter requested more information regarding how MIPS eligible clinicians participating for part of the performance period will be assessed against MIPS eligible clinicians participating for the full performance period. The commenter cautioned against penalizing MIPS eligible clinicians not practicing for reasons beyond their control, such as for health reasons. Other commenters expressed concern that MIPS eligible clinicians could attempt to game the system with extended leave. Other commenters supported the expectations for reporting when MIPS eligible clinicians have a break in their practice, and one commenter expressed concern about MIPS eligible clinicians who change groups because doing so may negatively impact group performance. The commenters believed a policy for exceptions may mitigate the problem and provide consistency. Another commenter stated that MIPS eligible clinicians with less than 12 months of performance data should be assessed on the period of time for which they do report.

Response: As discussed in this final rule with comment period, we are modifying our proposal to allow reporting for a minimum of a continuous 90-day period within the CY 2017 performance period for the majority of available submission mechanisms for all data in a given performance category and submission mechanism. We would like to note that we are finalizing that individual MIPS eligible clinician or groups who report less than 12 months of data (due to family leave, etc.) would be required to report all performance data available from the performance period. For example, for the performance period in 2017, MIPS eligible clinicians who have less than 90 days' worth of data would be required to submit all performance data that they have available. We are finalizing this proposal with modification to apply to any applicable performance period (for example, to any 90-day period). Based on the Medicare Part B data available to us, we do not intend to make any scoring adjustments based on the duration of the performance period. We recognize that a longer (that is, 12-month) performance period provides greater assurance of reliability with respect to the submitted data and therefore strongly encourage all MIPS eligible clinicians who have the ability to submit data for a period greater than 90 days, to do so.

Comment: A few commenters supported the proposed performance period, but requested that CMS increase its outreach to MIPS eligible clinicians who have not successfully reported under PQRS in the past to help them to achieve the reporting standard during this time. A few commenters stated that going forward CMS should ensure that the timeframes for annual MACRA regulations, subregulatory guidance and other agency communications are sufficient to allow MIPS eligible clinicians and health plans to act on the information in advance of the applicable performance years. For purposes of publishing the list of APMs, Medical Home Models, MIPS APMs, Advanced APMs, and eventually other-payer APMs, the commenter believed that CMS should start the process at least 15 months in advance of the applicable performance year, and finalize the list at least 9 months in advance of the applicable performance year.

Response: We appreciate the support. We have multiple mechanisms we have employed to reach out to all MIPS eligible clinicians to provide support. We will make every effort to ensure the timeframes for agency communications are sufficient to allow MIPS eligible clinicians and health plans to act on the information in advance of the applicable performance period. Please refer to section II.F.4. of this final rule with comment period for further information on how we will make clear the status of any APM upon its first public announcement.

Comment: Other commenters urged CMS to communicate submission problems to both vendors and practices as soon as possible to allow for alternative submission mechanisms and to encourage vendors to be open about their ability to meet data submission standards.

Response: We make every effort to communicate submission problems to stakeholders through multiple communication channels including health IT vendors, specialty societies, registries, and MIPS eligible clinicians as soon as possible and will continue to do so in the future.

Comment: One commenter supported using claims paid within 60 days after the performance period.

Response: We agree and appreciate the commenters support. We are finalizing our proposal to use claims that are processed within 60 days, after the end of the performance period for purposes of assessing performance and computing the MIPS payment adjustment.

After consideration of the comments we received regarding the MIPS performance period, we are finalizing a modification of our proposal of a 12-month performance period that occurs 2 years prior to the applicable payment year. For the transition year of MIPS, we believe it is important that we provide flexibility to MIPS eligible clinicians as they familiarize themselves with MIPS requirements while maintaining reliability. Therefore, we are finalizing at § 414.1320(a)(1) that for purposes of the 2019 MIPS payment year, for all performance categories and submission mechanisms except for the cost performance category and data for the quality performance category reported through the CMS Web Interface, for the CAHPS for MIPS survey, and for the all-cause hospital readmission measure, the performance period under MIPS is a minimum of a continuous 90-day period within CY 2017, up to and including the full CY (January 1, 2017 through December 31, 2017). Thus, MIPS eligible clinicians will only need to report for a minimum of a continuous 90-day period within CY 2017, for the majority of the Start Printed Page 77085submission mechanisms. This 90-day period can occur anytime within CY 2017, so long as the 90-day period begins on or after January 1, 2017, and ends on or before December 31, 2017. Additionally, for further flexibility and ease of reporting this 90-day period can differ across performance categories. For example, a MIPS eligible clinician may utilize a 90-day period that spans from June 1, 2017-August 30, 2017 for the improvement activities performance category and could use a different 90-day period for the quality performance category, such as August 15, 2017-November 13, 2017. The continuous 90-day period is a minimum; MIPS eligible clinicians may elect to report data on more than a continuous 90-day period, including a period of up to the full 12 months of 2017. We note there are special circumstances in which MIPS eligible clinicians may submit data for a period of less than 90 days and avoid a negative MIPS payment adjustment. For example, in some circumstances, MIPS eligible clinicians may meet data completeness criteria for certain quality measures in less than the 90-day period. Also, in instances where MIPS eligible clinicians do not meet the data completeness criteria for quality measures, we will provide partial credit for these measures as discussed in section II.E.6. of this final rule with comment period.

For groups that elect to utilize the CMS Web Interface or report the CAHPS for MIPS survey, we note that these submission mechanisms utilize certain assignment and sampling methodologies that are based on a 12-month period. In addition, administrative claims-based measures (this includes all of the cost measures and the all-cause readmission measure) are based on attributed population using the 12-month performance period. Accordingly, we are finalizing at § 414.1320(a)(2) that for purposes of the 2019 MIPS payment year, for data reported through the CMS Web Interface or the CAHPS for MIPS survey and administrative claims-based cost and quality measures, the performance period under MIPS is CY 2017 (January 1, 2017 through December 31, 2017). Please note that, unless otherwise stated, any reference in this final rule with comment period to the “CY 2017 performance period” is intended to be an inclusive reference to all performance periods occurring during CY 2017.

Additionally, we are finalizing at § 414.1320(b)(1) that for purposes of the 2020 MIPS payment year, the performance period for the quality and cost performance categories is CY 2018 (January 1, 2018 through December 31, 2018). For the improvement activities and advancing care information performance categories, we are finalizing the same approach for the 2020 MIPS payment year that we will have in place for the transition year of MIPS. Specifically, we are finalizing at § 414.1320(b)(2) that for purposes of the 2020 MIPS payment year, the performance period for the improvement activities and advancing care information performance categories is a minimum of a continuous 90-day period within CY 2018, up to and including the full CY 2018 (January 1, 2018 through December 31, 2018).

We are also finalizing a modification to our proposal, which was to use claims run-out data that are processed within 90 days, if operationally feasible, after the end of the performance period for purposes of assessing performance and computing the MIPS payment adjustment. Specifically, we are finalizing at § 414.1325(f)(2) to use claims with dates of service during the performance period that must be processed no later than 60 days following the close of the performance period for purposes of assessing performance and computing the MIPS payment adjustment.

Lastly, we are finalizing our proposal that individual MIPS eligible clinicians or groups who report less than 12 months of data (due to family leave, etc.) would be required to report all performance data available from the applicable performance period (for example, to any 90-day period).

5. MIPS Performance Category Measures and Activities

a. Performance Category Measures and Reporting

(1) Statutory Requirements

Section 1848(q)(2)(A) of the Act requires the Secretary to use four performance categories in determining each MIPS eligible clinician's final score under the MIPS: Quality; cost; improvement activities; and advancing care information. Section 1848(q)(2)(B) of the Act, subject to section 1848(q)(2)(C) of the Act, describes the measures and activities that, for purposes of the MIPS performance standards, must be specified under each performance category for a performance period.

Section 1848(q)(2)(B)(i) of the Act describes the measures and activities that must be specified under the MIPS quality performance category as the quality measures included in the annual final list of quality measures published under section 1848(q)(2)(D)(i) of the Act and the list of quality measures described in section 1848(q)(2)(D)(vi) of the Act used by QCDRs under section 1848(m)(3)(E) of the Act. Under section 1848(q)(2)(C)(i) of the Act, the Secretary must, as feasible, emphasize the application of outcome-based measures in applying section 1848(q)(2)(B)(i) of the Act. Under section 1848(q)(2)(C)(iii) of the Act, the Secretary may also use global measures, such as global outcome measures and population-based measures, for purposes of the quality performance category. Section 1848(q)(2)(B)(ii) of the Act describes the measures and activities that must be specified under the cost performance category as the measurement of cost for the performance period under section 1848(p)(3) of the Act, using the methodology under section 1848(r) of the Act as appropriate, and, as feasible and applicable, accounting for the cost of drugs under Part D.

Section 1848(q)(2)(C)(ii) of the Act allows the Secretary to use measures from other CMS payment systems, such as measures for inpatient hospitals, for purposes of the quality and cost performance categories, except that the Secretary may not use measures for hospital outpatient departments, other than in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists. In the proposed rule, we solicited comment on how it might be feasible and when it might be appropriate to incorporate measures from other systems into MIPS for clinicians that work in facilities such as inpatient hospitals. For example, it may be appropriate to use such measures when other applicable measures are not available for individual MIPS eligible clinicians or when strong payment incentives are tied to measure performance, either at the facility level or with employed or affiliated MIPS eligible clinicians.

Section 1848(q)(2)(B)(iii) of the Act describes the measures and activities that must be specified under the improvement activities performance category as improvement activities under subcategories specified by the Secretary for the performance period, which must include at least the subcategories specified in section 1848(q)(2)(B)(iii)(I) through (VI) of the Act. Section 1848(q)(2)(C)(v)(III) of the Act defines a improvement activities as an activity that relevant eligible clinician organizations and other relevant stakeholders identify as improving clinical practice or care delivery and that the Secretary determines, when effectively executed, is likely to result in improved outcomes. Section 1848(q)(2)(B)(iii) of the Act Start Printed Page 77086requires the Secretary to give consideration to the circumstances of small practices (consisting of 15 or fewer professionals) and practices located in rural areas and geographic HPSAs in establishing improvement activities.

Section 1848(q)(2)(B)(iv) of the Act describes the measures and activities that must be specified under the advancing care information performance category as the requirements established for the performance period under section 1848(o)(2) for determining whether an eligible clinician is a meaningful EHR user.

As discussed in the proposed rule (81 FR 28173), section 1848(q)(2)(C)(iv) of the Act requires the Secretary to give consideration to the circumstances of non-patient facing MIPS eligible clinicians in specifying measures and activities under the MIPS performance categories and allows the Secretary, to the extent feasible and appropriate, to take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category. In doing so, the Secretary is required to consult with non-patient facing professionals.

Section 101(b) of MACRA amends certain provisions of section 1848(k), (m), (o), and (p) of the Act to generally provide that the Secretary will carry out such provisions in accordance with section 1848(q)(1)(F) of the Act for purposes of MIPS. Section 1848(q)(1)(F) of the Act provides that, in applying a provision of section 1848(k), (m), (o), and (p) of the Act for purposes of MIPS, the Secretary must adjust the application of the provision to ensure that it is consistent with the MIPS requirements and must not apply the provision to the extent that it is duplicative with a MIPS provision.

We did not request comments on this section, but we did receive a few comments which are summarized below.

Comment: Some commenters requested that MIPS begin in its most basic structure involving as few measures as possible due to the fact that the practices have little or no experience in these processes and very limited staff, particularly in smaller practices. Another commenter recommended that CMS reduce the number of MIPS measures across the four performance categories. The commenter expressed concern that the implementation time will be slow due to developing relationships with data submission vendors which will lead to practices being overwhelmed by the number of measures.

Some commenters suggested that instead of focusing on four performance categories simultaneously, CMS should focus on interoperability and making that functionality fully workable before moving on to the next step.

One commenter was very concerned that the cumulative effect of four sets of largely separate measures and activities, scoring methodologies, and reporting requirements could result in more administrative work for practices, not less, and encouraged CMS to consider additional ways to reduce the MIPS reporting burden for all practices such as reducing the number of required measures or activities in each MIPS performance category, lowering measure thresholds, establishing consistent definitions (such as for “small practices”) across categories, and providing more opportunities for “partial credit.” Other commenters urged CMS to take every possible step to dramatically simplify provisions and requirements, and to revise and develop practice-focused communications to reduce any remaining perceived complexity.

Another commenter agreed with the level of flexibility CMS has proposed for MIPS eligible clinicians by allowing them to choose the specific quality performance measures most applicable to their practice and stated that CMS should design the requirements within the performance categories to work in concert with each other to ensure meaningful quality measurement. Some commenters asked if there will be interoperability between the four MIPS performance categories.

Response: As discussed in section II.E.5.b.(3) of this final rule with comment period, we have decreased the data submission criteria for the quality performance category to a level that reduces burden while still maintaining meaningful measurements at this time. We will continue to assess this approach to improve on this aspect in the future. We appreciate the commenters' request for simplicity and the need for clear communications. We will continue to look for ways to simplify the MIPS program in the future and will work to ensure clear communications with the MIPS eligible clinician community on all of the MIPS provisions. We note that the definition of a small practice is the same across all four performance categories and is consistent with the statute. We have codified the definition of a small practice for MIPS at § 414.1305 as practices consisting of 15 or fewer clinicians and solo practitioners.

Further, we are required by statute to utilize the four performance categories to determine the final score. We appreciate the support and agree that the goal of the MIPS program is that the four performance categories should work in concert with one another. In addition, as discussed in section II.E.5. of this final rule with comment period, we have modified our policies to have the four performance categories work more in concert with one another.

Comment: One commenter requested that CMS simplify the MIPS to the extent practicable by further limiting the number of measures reportable under each performance category and refraining from introducing any new and previously untested measures (for example, population-based quality measures).

Response: In any quality measurement program, we must balance the data collection burden that we must impose on MIPS eligible clinicians with the resulting quality performance data that we will receive. We believe that without sufficiently robust performance data, we cannot accurately measure quality performance. Therefore, we believe that we have appropriately struck a balance between requiring sufficient quality measure data from MIPS eligible clinicians and ensuring robust quality measurement at this time. Regarding the global and population-based measures, we refer the reader to section II.E.5.b.(6) of this final rule with comment period.

Comment: One commenter stated that CMS appears to view the four MIPS categories as separate but should treat them holistically. The commenter suggested unifying definitions across all MIPS categories, such as the proposed definition of a “small practice” as consisting of 15 or fewer clinicians.

Response: We are required by statute to utilize the four performance categories to determine the final score. As the program evolves we believe the performance categories will become more streamlined and integrated. The definition of a small practice is the same across all four performance categories and is consistent with the statute. We have codified the definition of a small practice for MIPS at § 414.1305 as practices consisting of 15 or fewer clinicians and solo practitioners.

Comment: Some commenters suggested combining the improvement activities and advancing care information performance categories.

Response: Each of these performance categories is statutorily mandated, and we believe each has a distinct role in the MIPS program.

Comment: Another commenter stated that data and reporting requirements should generally be efficient, strong, Start Printed Page 77087and actionable for the purposes of quality improvement, payment, consumer decision-making, and any other areas where they can be useful. Another commenter generally recommended that quality measures in the MIPS program be meaningful, that innovative science should be accommodated when achieving quality aims in areas without measures or therapies, and incentives surrounding cost should reward high-value care, not simply low cost.

Response: We appreciate the commenters' support.

We have considered the comments received and will take them into consideration in the future development of performance feedback through separate notice-and-comment rulemaking.

(2) Submission Mechanisms

We proposed at § 414.1325(a) that individual MIPS eligible clinicians and groups would be required to submit data on measures and activities for the quality, improvement activities and advancing care information performance categories. We did not propose at § 414.1325(f) any data submission requirements for the cost performance category and for certain quality measures used to assess performance on the quality performance category and for certain activities in the improvement activities performance category. For the cost performance category, we proposed that each individual MIPS eligible clinician's and group's cost performance would be calculated using administrative claims data. As a result, individual MIPS eligible clinicians and groups would not be required to submit any additional information for the cost performance category. In addition, we would be using administrative claims data to calculate performance on a subset of the MIPS quality measures and the improvement activities performance category, if technically feasible. For this subset of quality measures and improvement activities, MIPS eligible clinicians and groups would not be required to submit additional information. For individual clinicians and groups that are not MIPS eligible clinicians, such as physical therapists, but elect to report to MIPS, we would calculate administrative claims cost measures and quality measures, if data are available. We proposed multiple data submission mechanisms for MIPS as outlined in Tables 1 and 2 in the proposed rule (81 FR 28182) and the final policies identified in Tables 3 and 4 in this final rule with comment period, to provide MIPS eligible clinicians with flexibility to submit their MIPS measures and activities in a manner that best accommodates the characteristics of their practice. We note that other terms have been used for these submission mechanisms in earlier programs and in industry.

Table 1—Proposed Data Submission Mechanisms for MIPS Eligible Clinicians Reporting Individually as TIN/NPI

Performance category/submission combinations acceptedIndividual reporting data submission mechanisms
QualityClaims. QCDR. Qualified registry. EHR. Administrative claims (no submission required).
CostAdministrative claims (no submission required).
Advancing Care InformationAttestation. QCDR. Qualified registry. EHR.
Improvement ActivitiesAttestation. QCDR. Qualified registry. EHR. Administrative claims (if technically feasible, no submission required).

Table 2—Proposed Data Submission Mechanisms for Groups

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 (no submission required).
CostAdministrative claims (no submission required).
Advancing Care InformationAttestation. QCDR. Qualified registry. EHR. CMS Web Interface (groups of 25 or more).
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Improvement ActivitiesAttestation. QCDR. Qualified registry. EHR. CMS Web Interface (groups of 25 or more). Administrative claims (if technically feasible, no submission required).

We proposed at § 414.1325(d) that MIPS eligible clinicians and groups may elect to submit information via multiple mechanisms; however, they must use the same identifier for all performance categories and they may only use one submission mechanism per performance category. For example, a MIPS eligible clinician could use one submission mechanism for sending quality measures and another for sending improvement activities data, but a MIPS eligible clinician could not use two submission mechanisms for a single performance category such as submitting three quality measures via claims and three quality measures via registry. We believe the proposal to allow multiple mechanisms, while restricting the number of mechanisms per performance category, offers flexibility without adding undue complexity.

For individual MIPS eligible clinicians, we proposed at § 414.1325(b), that an individual MIPS eligible clinician may choose to submit their quality, improvement activities, and advancing care information performance category data using qualified registry, QCDR, or EHR submission mechanisms. Furthermore, we proposed at § 414.1400 that a qualified registry, health IT vendor, or QCDR could submit data on behalf of the MIPS eligible clinician for the three performance categories: Quality, improvement activities, and advancing care information. In the proposed rule (81 FR 28280), we expanded third party intermediaries' capabilities by allowing them to submit data and activities for quality, improvement activities, and advancing care information performance categories. Additionally, we proposed at § 414.1325(b)(4) and (5) that individual MIPS eligible clinicians may elect to report quality information via Medicare Part B claims and their improvement activities and advancing care information performance category data through attestation.

For groups that are not reporting through the APM scoring standard, we proposed at § 414.1325(c) that these groups may choose to submit their MIPS quality, improvement activities, and advancing care performance category information data using qualified registry, QCDR, EHR, or CMS Web Interface (for groups of 25+ MIPS eligible clinicians) submission mechanisms. Furthermore, we proposed at § 414.1400 that a qualified registry, health IT vendor that obtains data from a MIPS eligible clinician's CEHRT, or QCDR could submit data on behalf of the group for the three performance categories: Quality, improvement activities, and advancing care information. Additionally, we proposed that groups may elect to submit their improvement activities or advancing care information performance category data through attestation.

For those MIPS eligible clinicians participating in an APM that uses the APM scoring standard, we refer readers to the proposed rule (81 FR 28234), which describes how certain APM Entities submit data to MIPS, including separate approaches to the quality and cost performance categories for APMs.

We proposed one exception to the requirement for one reporting mechanism per performance category. Groups that elect to include CAHPS for MIPS survey as a quality measure must use a CMS-approved survey vendor. Their other quality information may be reported by any single one of the other proposed submission mechanisms.

While we proposed to allow MIPS eligible clinicians and groups to submit data for different performance categories via multiple submission mechanisms, we encouraged MIPS eligible clinicians to submit MIPS information for the improvement activities and advancing care information performance categories through the same reporting mechanism that is used for quality reporting. We believe it would reduce administrative burden and would simplify the data submission process for MIPS eligible clinicians by having a single reporting mechanism for all three performance categories for which MIPS eligible clinicians would be required to submit data: Quality, improvement activities, and advancing care information performance category information. However, we were concerned that not all third party entities would be able to implement the changes necessary to support reporting on all performance categories in the transition year. We solicited comments for future rulemaking on whether we should propose requiring health IT vendors, QCDRs, and qualified registries to have the capability to submit data for all MIPS performance categories.

As noted at (81 FR 28181), we proposed that MIPS eligible clinicians may report measures and activities using different submission methods for each performance category if they choose for reporting data for the CY 2017 performance period. As we gain experience under MIPS, we anticipate that in future years it may be beneficial for, and reduce burden on MIPS eligible clinicians and groups, to require data for multiple performance categories to come through a single submission mechanism.

Further, we will be flexible in implementing MIPS. For example, if a MIPS eligible clinician does submit data via multiple submission mechanisms (for example, registry and QCDR), we would score all the measures in each submission mechanism and use the highest performance score for the MIPS eligible clinician or group as described at (81 FR 28247). However, we would not be blending measure results across submission mechanisms. We encourage MIPS eligible clinicians to report data for a given performance category using a single data submission mechanism.

Finally, section 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs under section 1848(m)(3)(E) of the Act in carrying out MIPS. Section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary, under the final score methodology, to encourage MIPS eligible clinicians to report on applicable measures with respect to the quality performance category through the use of CEHRT and QCDRs. We note that the proposed rule used the term CEHRT and certified health IT in different contexts. For an explanation of these terms and contextual use within Start Printed Page 77089the proposed rule, we refer readers to the proposed rule (81 FR 28256).

We have multiple policies to encourage the usage of QCDRs and CEHRT. In part, we are promoting the use of CEHRT by awarding bonus points in the quality scoring section for measures gathered and reported electronically via the QCDR, qualified registry, CMS Web Interface, or CEHRT submission mechanisms see the proposed rule (81 FR 28247). By promoting the use of CEHRT through various submission mechanisms, we believe MIPS eligible clinicians have flexibility in implementing electronic measure reporting in a manner which best suits their practice.

To encourage the use of QCDRs, we have created opportunities for QCDRs to report new and innovative quality measures. In addition, several improvement activities emphasize QCDR participation. Finally, we allow for QCDRs to report data on all MIPS performance categories that require data submission and hope this will become a viable option for MIPS eligible clinicians. We believe these flexible options will allow MIPS eligible clinicians to more easily meet the submission criteria for MIPS, which in turn will positively affect their final score.

We requested comments on these proposals.

The following is summary of the comments we received on our proposals regarding MIPS data submission mechanisms.

Comment: Several commenters expressed concern that, by providing too many data submission mechanisms and reporting flexibility to MIPS eligible clinicians, CMS would be allowing MIPS eligible clinicians to report on arbitrary quality metrics or metrics on which those MIPS eligible clinicians are performing well versus metrics that reflect areas of needed improvement. The commenters recommended that CMS ensure high standard final scoring, promote transparency, and enable meaningful comparisons of the clinicians' performance for specific services.

Response: We believe allowing multiple data submission mechanisms is beneficial to the MIPS eligible clinicians as they may choose whichever data submission mechanism works best for their practice. We have provided many data submission options to allow the utmost flexibility for the MIPS eligible clinician. Based on our experience with existing quality reporting programs such as PQRS, we do not believe multiple data submission mechanisms will encourage MIPS eligible clinicians to report on arbitrary quality metrics or metrics on which those MIPS eligible clinicians are performing well versus metrics that reflect areas of needed improvement. We will monitor measure selection and performance through varying data submission mechanisms as we implement the program. However, we agree with commenters that measuring meaningful quality measures and encouraging improvement in the quality of care are important goals of the MIPS program. As such, we will monitor whether data submission mechanisms are allowing MIPS eligible clinicians to focus only on metrics where they are already performing well and will address any modifications needed to our policies based on these monitoring efforts in future rulemaking.

Comment: Another commenter supported the requirement to use only one submission mechanism per performance category. Other commenters appreciated that CMS is allowing MIPS eligible clinicians to choose data submission options that vary by performance category.

Response: We agree with the commenters and appreciate the support. We are finalizing the policy as proposed of requiring MIPS eligible clinicians to submit all performance category data for a specific performance category via the same data submission mechanism. In addition, we are finalizing the policy to allow MIPS eligible clinicians to submit data using differing submission mechanisms across different performance categories. We refer readers to section II.E.5.a.(2) of this final rule with comment period where we discuss our approach for the rare situations where a MIPS eligible clinician submits data for a performance category via multiple submission mechanisms (for example, submits data for the quality performance category through a registry and QCDR), and how we score those MIPS eligible clinicians. We further note that in that section we are seeking comment for further consideration on different approaches for addressing this scenario.

Comment: Another commenter sought clarification as to whether MIPS eligible clinicians may use more than one data submission method per performance category. The commenter recommended the use of multiple data submission methods across performance categories because there are currently significant issues with extracting clinical data from EHRs to provide to a third party for calculation. The commenter believed that requiring a single submission method may force MIPS eligible clinicians to submit inaccurate data that does not reflect actual performance.

Response: As noted in this final rule with comment period, MIPS eligible clinicians will have the flexibility to choose different submission mechanisms across different performance categories for example, utilizing a registry to submit data for quality and CEHRT for the advancing care information performance category. MIPS eligible clinicians will need to choose however, one submission mechanism per performance category, except for MIPS eligible clinicians who elect to report the CAHPS for MIPS survey, which must be reported via a CMS-approved survey vendor in conjunction with another submission mechanism for all other quality measures. As discussed in this section of this final rule with comment period, we are finalizing policy that allows MIPS eligible clinicians to choose to report for a minimum of as few as 90 consecutive days within CY 2017 for the majority of submission mechanisms. We believe this allows for adequate time for those MIPS eligible clinicians who are not already successfully reporting quality measures meaningful to their practice via CEHRT under the EHR Incentive Program and/or PQRS to evaluate their options and select the measures and a reporting mechanism that will work best for their practice. We will be providing subregulatory guidance for MIPS eligible clinicians who encounter issues with extracting clinical data from EHRs.

Comment: A few commenters recommended that CMS reduce complexity by reducing the number of available reporting methods as health IT reduces the need to retain claims and registry-based reporting in the program. Other commenters supported the use of electronic data reporting mechanisms noted that due to the complexity of the MIPS, they were concerned that using claims data submission for quality measures may place MIPS eligible clinicians at a disadvantage due to the significant lag between performance feedback and the performance period.

Response: We appreciate the commenters' feedback. We agree that the usage of health IT in the future will reduce our reliance on non-IT methods of reporting such as claims. We do believe, however, that we cannot eliminate submission mechanisms such as claims until broader adoption of health IT and registries occurs. Therefore, we do intend to finalize both the claims and registry submission mechanisms. We also refer readers to section II.E.8.a. for final polices regarding performance feedback.Start Printed Page 77090

Comment: Some commenters expressed appreciation for our proposal to continue claims-based reporting for the quality performance category because this is the most convenient method for hospitals-based clinicians. The commenters explained that hospital-based MIPS eligible clinicians must use the EHRs of the hospitals in which they practice, which may limit the capabilities of these EHRs for reporting measures. Other commenters requested that CMS ensure that the option for claims reporting was available to all MIPS eligible clinicians, noting that there was only one anesthesia-related quality measure available for reporting via registry. Under such circumstances, the commenters asked CMS to ensure that MIPS did not impose excessive time and cost burdens on MIPS eligible clinicians by forcing them to use a different submission mechanism. Another commenter noted that the preservation of the claims-based reporting option will help those emergency medicine practices that have relied on this reporting option in the past make the transition to the new MIPS requirements. The commenter noted the additional administrative burden associated with registry reporting, including registration fees.

Response: We appreciate the commenters' support. We do note that we intend to reduce the number of claims-based measures in the future as more measures are available through health IT mechanisms such as registries, QCDRs, and health IT vendors, but we understand that many MIPS eligible clinicians still submit these types of measures. We believe claims-based measures are a necessary option to minimize reporting burden for MIPS eligible clinicians at this time. We intend to work with MIPS eligible clinicians and other stakeholders to continue improving available measures and reporting methods for MIPS. In addition, we are finalizing policies that offer MIPS eligible clinicians substantial flexibility and sustain proven pathways for successful participation. Those MIPS eligible clinicians who are not already successfully reporting quality measures meaningful to their practice via one of these pathways will need to evaluate the options available to them and choose which available reporting mechanism and measures they believe will work best for their practice.

Comment: A few commenters recommended that more quality measures be made available for reporting via claims or EHRs noting that there were more quality measures available for reporting by registry compared with EHRs or claims. The commenters stated that this will push clinicians to sign up with registries, undercuts fully using EHRs, and only services the interests of organizations who manage registries.

Response: We appreciate the commenters' concern and are working with measure developers to develop more measures that are electronically based. We refer the commenter to the Measure Development Plan for more information https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Value-Based-Programs/​MACRA-MIPS-and-APMs/​Final-MDP.pdf.

Additionally, in section II.E.9.(b). of this final rule with comment period, we have expanded health IT vendors' opportunities by allowing health IT vendors to submit data on measures, activities, or objectives for any of the following MIPS performance categories: (i) Quality; (ii) improvement activities; or (iii) advancing care information. In addition, the health IT vendor submitting data on behalf of a MIPS eligible clinician or group would be required to obtain data from the MIPS eligible clinician's certified EHR technology. However, the health IT vendor would be able to submit the same information the qualified registry is able to. Therefore, we do not believe there is a disparity between health IT vendors and qualified registry's quality data submission capabilities.

Comment: Other commenters stated that the use of CEHRT in all areas of the MIPS program should be required rather than just encouraged. The commenters stated that the use of CEHRT is required for participation in the Meaningful Use EHR Incentive Programs, is vitally important for ensuring successful interoperability, and is already part of the definition of a Meaningful EHR User for MIPS.

Response: We do not believe it is appropriate to require CEHRT in all areas of the MIPS program as many MIPS eligible clinicians may not have had past experience relevant to the performance categories and use of EHR technology because they were not previously eligible to participate in the Medicare EHR Incentive Program. The restructuring of program requirements described in this final rule with comment period are geared toward increasing participation and EHR adoption. We believe this is the most effective way to encourage the adoption of CEHRT, and introduce new MIPS eligible clinicians to the use of certified EHR technology and health IT overall. As discussed in section II.E.6.a.(2)(f) of this final rule with comment period, we are promoting the use of CEHRT by awarding bonus points in the quality scoring section for measures gathered and reported electronically via the QCDR, qualified registry, CMS Web Interface, or CEHRT submission mechanisms. By promoting use of CEHRT through various submission mechanisms, we believe MIPS eligible clinicians have flexibility in implementing electronic reporting in a manner which best suits their practice.

Comment: One commenter requested information on how non-Medicare payers would route claims data to CMS for purposes of considering cost performance category data.

Response: All measures used under the cost performance category would be derived from Medicare administrative claims data submitted for billing on Part B claims by MIPS eligible clinicians and as a result, participation would not require use of a separate data submission mechanism. Please note that the cost performance category is being reweighted to zero for the transition year of MIPS. Refer to section II.E.5.e. of this final rule with comment for more information on the cost performance category.

Comment: Other commenters requested clarification on the difference between “claims” and “administrative claims” as reporting methods, citing slides 24 and 39 of the May 10th Quality Payment Program presentation, available at https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Value-Based-Programs/​MACRA-MIPS-and-APMs/​Quality-Payment-Program.html. The commenters were confused because “claims” was listed as a method of reporting but it was stated that “administrative claims” will not require submission.

Response: The “claims” submission mechanism refers to those quality measures as described in section II.E.5.b.(6). of this final rule with comment period. The claims submission mechanism requires MIPS eligible clinicians to append certain billing codes to denominator eligible claims to indicate to us the required quality action or exclusion occurred. Conversely, the administrative claims submission mechanism refers to those measures described in section II.E.5.b. for the quality performance category and section II.E.5.e. for the cost performance category of this final rule with comment period. Administrative claims submissions require no separate data submission to CMS. Rather, we calculate these measures based on data available from MIPS eligible clinicians' billings on Medicare Part B claims.Start Printed Page 77091

Comment: Other commenters stated that some of the measures and activities, such as the CAHPS for MIPS survey, were dependent on third party intermediaries, over which practices have little control. The commenters recommended that CMS reduce requirements that are outside of the practice's control.

Response: We believe the MIPS program has a broad span of measures and activities from which to choose. There are many measures and activities that are not dependent on a third party intermediary. We encourage MIPS eligible clinicians to report the measures and activities that are most meaningful to their practice.

Comment: Another commenter stated that if CMS were to require vendors to have the capability to submit data for all performance categories, a vendor would need adequate time to implement any required changes going forward, would need CMS to produce implementation guides for 2017 reporting as soon as possible with the capability to ask CMS clarifying questions, and would need a testing tool no later than the 3rd quarter. Several commenters did not support the proposed requirement that vendors have the capability to submit data for all MIPS performance categories. The commenters stated many product developers and product or service vendors have developed solutions tailored to specific areas of healthcare quality and performance improvement. The commenters stated that given the breadth of the proposed MIPS requirements, CMS should not require health IT companies to have the capability to submit information for all four MIPS performance categories because this task may be outside of their organizational and client priorities. Another commenter stated that while they appreciate CMS' attempts to reduce administrative burden they have a concern that third party entities will not be able to implement the necessary changes to support reporting on all performance categories in the transition year. In addition, the commenter was concerned that the additional cost of creating this functionality will be passed on to MIPS eligible clinicians in the form of higher fees for using those products and services. The commenter urged CMS to work with health IT developers, vendors, and other data intermediaries to ensure that data products and services evolve as CMS's policies evolve and to ensure adequate advanced notice of upcoming changes so that MIPS eligible clinicians will not be penalized for failing to report data the third party intermediary's technology was not updated to collect.

Response: We would like to explain that we are not finalizing a requirement that a third party intermediary submitting data on behalf of a MIPS eligible clinician or group must become qualified to submit data for multiple MIPS performance categories, nor are we finalizing a certification requirement for submission of data. We are instead finalizing specific requirements for QCDRs related to quality data submission, and for a health IT vendor or other authorized third party intermediary that is submitting data for any or all of the MIPS performance categories on behalf of an MIPS eligible clinician or group must meet the form and manner requirements for each submission method. We direct readers to section II.E.9.b. of this final rule with comment period for further discussion of health IT vendor and other authorized third party intermediaries. We direct readers to section II.E.9.a. of this final rule with comment period for further discussion of submission requirements for QCDRs.

Comment: Another commenter stated that the CMS Web Interface should have fewer down times during the first quarter submission period, following the performance period, to compensate for MIPS eligible clinicians' need to submit their files.

Response: We intend to make every effort to keep the CMS Web Interface from having down times during the first quarter submission period. In some instances, down times are required to account for necessary system maintenance within CMS. When these down times do occur, we make every effort to ensure that the down times do not occur near final submission deadlines and to notify all groups and impacted parties well in advance so they can account for these down times during the data submission period.

Comment: One commenter encouraged utilizing EHRs and claims to collect quality measure data whenever possible.

Response: We agree with utilizing EHR whenever possible and encourage the use of EHR to collect data whenever possible. However, we intend to reduce the number of claims-based measures that in future years, but we note that many MIPS eligible clinicians still submit these types of measures. We believe claims-based measures are a necessary option to minimize reporting burden for MIPS eligible clinicians. We intend to work with MIPS eligible clinicians and other stakeholders to continue improving available measures and reporting methods for MIPS.

Comment: One commenter expressed concern that multi-specialty groups reporting through a QCDR would face challenges if multiple specialties wanted to report non-MIPS measures. This commenter believed this would require reporting via two different submission mechanisms.

Response: QCDRs are able to report both non-MIPS measures and MIPS measures. They are provided a great deal of flexibility and should be able to report for multiple specialties.

Comment: Another commenter requested clarity regarding the submission mechanisms for a group. The commenter sought flexibility to use the most appropriate submission mechanism for each of the performance categories. Another commenter suggested continuing 2017 reporting via CMS Web Interface for groups. The commenter stated that at a minimum, the CMS Web Interface reporting and EHR direct reporting should be maintained.

Response: Please refer to the final submission mechanisms in Tables 3 and 4 of this final rule with comment period for the available submission mechanisms for all MIPS eligible clinicians.

Comment: Another commenter expressed concern that CMS proposed to allow measures which are available to report via EHR technology to be reported via a QCDR, because the commenter believed this would result in unnecessary burden as practices would be required to seek another data submission vendor beyond their EHR vendor. The commenter recommended that CMS allow MIPS eligible clinicians to report quality measures and improvement activities using their certified EHR technology.

Response: MIPS eligible clinicians will have the flexibility to submit their quality measures and improvement activities using their certified EHR technology. The health IT vendor would need to meet the requirements as described in section II.E.9.b. of this final rule with comment period to offer this flexibility to their clients.

Comment: A few commenters agreed with the proposal to allow third party submission entities, such as QCDRs and qualified registries, to submit data for the performance categories of quality, advancing care information, and improvement activities. The commenters believed that allowing MIPS eligible clinicians to use a single, third party data submission method reduces the administrative burden on MIPS eligible clinicians, facilitates consolidation and standardization of data from disparate EHRs and other systems, and enables the third parties to provide timely, actionable feedback to Start Printed Page 77092MIPS eligible clinicians on opportunities for improvement in quality and value. Other commenters agreed with the proposals that encourage the use of QCDRs because QCDRs are able to quickly implement new quality measures to assist MIPS eligible clinicians with accurately measuring, reporting, and taking action on data most meaningful to their practices. Another commenter stated that vendors and QCDRs should have the capability to submit data for all MIPS performance categories. The commenter believed that working through a single vendor is the only way to provide a full picture of overall performance.

Response: We thank the commenters for their support.

Comment: A few commenters expressed support for the Quality Payment Program's approach of streamlining the PQRS, VM, and EHR Incentive Program into MIPS and encouraged CMS to continue to allow existing data reporting tools to report MIPS quality data. Hospitals have already made significant investments in existing reporting tools. Other commenters supported the option to use a single reporting mechanism under MIPS. The commenters considered this a positive development, and one that would be attractive to many groups and hospitals. Some commenters noted that CMS offers significant flexibility across performance category reporting options, and supported the proposal to accept data submissions from multiple mechanisms. The commenters urged CMS to retain this flexibility in future years and to hold QCDR and other vendors accountable for offering MIPS reporting capabilities across all performance categories. One commenter was pleased that CMS is allowing flexibility in measure selection and reporting via any reporting mechanism, and report as an individual or a group. Another commenter supported the proposal allowing MIPS eligible clinicians who are in a group to report on MIPS either as part of the group or individually. This flexibility would allow low performing groups the opportunity to reap the benefits of their higher performance. Other commenters were very supportive of the use of bonus points in the quality performance category to encourage the use of CEHRT and electronic reporting of CQMs.

Response: We thank the commenters for their support on the various approaches. We would like to explain that groups must report either entirely as a group or entirely as individuals; groups may not have only some individual reporting. Groups must decide to report as a group across all four performance categories.

Comment: Another commenter recommended that CMS adopt a clear, straightforward, and prospective process for practices to determine whether a MIPS performance category applies to their particular specialty and subspecialty.

Response: We agree with the commenter and are working to establish educational tools and materials that will clearly indicate to MIPS eligible clinicians their requirements based on their specialty or practice type.

Comment: One commenter urged CMS to offer a quality and cost performance category measure reporting option in which hospital-based MIPS eligible clinicians can use the hospital's measure performance under CMS hospital quality programs for purposes of MIPS.

Response: We appreciate the feedback and will take it into consideration for future rulemaking. We also note that in the Appendix in Table C of this final rule with comment period we have created a specialty-specific measure set for hospitalists.

Comment: Another commenter recommended that CMS and HRSA collaborate to develop a data submission mechanism that would allow MIPS eligible clinicians practicing in FQHCs to submit quality data one time for both MIPS and Uniform Data System (UDS).

Response: We intend to address this option in the future through separate notice-and-comment rulemaking.

Comment: Some commenters supported the proposed data submission mechanisms and the proposal that MIPS eligible clinicians and groups must use the same mechanism to report for a given performance category with the exception of those reporting the CAHPS for MIPS survey.

Response: We thank the commenters for their support.

Comment: Other commenters agreed with the proposal to maintain a manual attestation portal option for some of the performance categories. The commenters believed that this option provided MIPS eligible clinicians with an option of consolidating and submitting data on their own, which for some may reduce their overall cost to participate. The commenters recommended that this option remain in place for the future, but that if CMS decided to remove it, they provide EHR vendors at least 18 months' notice to develop and deploy data submission mechanisms.

Response: We appreciate the support and will take the feedback into consideration in the future.

Comment: Another commenter encouraged CMS to ensure that the reporting requirements for MIPS are aligned with each of the American Board of Medical Specialties (ABMS) Member Board's requirements for Maintenance of Certification, particularly activities required to fulfill Part IV: Improvement in Medical Practice.

Response: We align our quality efforts where possible. We intend to continue to receive input from stakeholders, including ABMS, in the future.

Comment: One commenter suggested that CMS ensure that the MIPS reporting process is simple to understand, conducive to automated reporting and clinically relevant.

Response: We believe we have made the reporting process as flexible and simple as possible for the MIPS program at this time. We have provided several data submission mechanisms, activities, and measures for MIPS eligible clinicians to choose from. We intend to continue to work to improve the program in the future as we gain experience under the Quality Payment Program.

Comment: Another commenter was appreciative that CMS outlined a data validation and auditing process in the proposed rule. The commenter requested more details about implementation, including CMS' timeline for providing performance reports to MIPS eligible clinicians.

Response: We thank the commenters for their support. We refer readers to section II.E.8.e. for information on data validation and section II.E.8.a. for information on performance feedback of this final rule with comment period.

Comment: A few commenters urged CMS to integrate patient and family caregiver perspectives as part of Quality Payment Program development. The commenters noted that value and quality are often perceived through “effectiveness” and “cost” whereas the patient typically prioritizes outcomes beyond clinical measures.

Response: We agree that the patient and family caregiver perspective is important, but note that we would expect patients and caregivers to prioritize successful health outcomes. We are finalizing the policy that the CAHPS for MIPS survey would count as a patient experience measure which is a type of high priority measure. In addition, a MIPS eligible clinician may be awarded points under the improvement activities performance category as the CAHPS for MIPS survey is included in the Patient Safety and Practice Assessment subcategory.Start Printed Page 77093

Comment: One commenter expressed concern that no measures exist that are useful to MIPS eligible clinicians working in multiple settings with diverse patient populations.

Response: We believe the MIPS program has a broad span of measures and activities from which to choose. There are many measures and activities that are applicable to multiple treatment facility types and diverse patient populations. We encourage MIPS eligible clinicians to report the measures and activities that are most meaningful to their practice.

Comment: One commenter stated that CMS should clarify the reporting options for nephrologists who practice in multiple settings. The commenter urged CMS to provide illustrative examples of options for nephrologists based on actual sample clinical practices.

Response: The final data submission options for all MIPS eligible clinicians are outlined in this final rule with comment period in Tables 3 and 4. We intend to provide further subregulatory guidance and training opportunities for all MIPS eligible clinicians in the future. In addition, the MIPS eligible clinician may reach out to the Quality Payment Program Service Center with any questions.

Comment: Other commenters recommended that CMS not amend the technical specifications for eCQMs until MIPS eligible clinicians are required to transition to 2015 Edition CEHRT to report data for MIPS. In addition, the commenters requested that CMS maintain the eMeasure versions issued with the EHR Incentive Program Stage 2 final rule until that transition point. The commenters noted that by delaying any changes to eCQM measures until 2018, CMS will give the health IT industry and MIPS eligible clinicians the necessary time to adapt to new reporting demands and respond appropriately to new specifications.

Response: We understand the concerns of needing necessary time to adapt to new reporting requirements. Therefore, we did not make major amendments to the technical standards for eCQMs. We have updated measure specification for various eCQMs to align with current clinical guidelines. However, this alignment should not impact technical standards and certification requirements. We plan to update the EHR community to allow necessary time for implementers to adapt any new standards required to report eCQMs in the future.

Comment: One commenter recommended that technologies such as the CMS Web Interface be available for submission of all data, not just the quality performance category.

Response: We appreciate the feedback and note that we are expanding the ability of the CMS Web Interface to be used for submissions on improvement activities, advancing care information, and quality performance categories.

Comment: Another commenter stated that the avenue for reporting different measures requires careful consideration because there are appropriate avenues of reporting depending upon different measure types. The commenter stated that this should be taken into consideration during measure development.

Response: We appreciate the feedback and will take this suggestion into consideration in the future.

Comment: One commenter supported allowing groups to utilize a CMS‐approved survey vendor for CAHPS for MIPS survey data collection in conjunction with another data submission mechanism. Another commenter proposed expanding the survey option in the future to include a CMS‐approved survey vendor for CAHPS for MIPS survey data collection for MIPS eligible clinicians reporting individually.

Response: We would like to note that when a MIPS eligible clinician utilizes the CAHPS for MIPS survey they must also utilize another data submission mechanism in conjunction with it. We will take the suggestion of expanding the survey option to individuals in the future.

Comment: One commenter believed that CMS could simplify MIPS reporting by streamlining the number of submission methods and focusing on the options that are most appropriate for each performance category. The commenter recommended the following options: (1) Quality: EHR Direct, QCDR, Qualified Registry, CMS Web Interface, remove Claims; (2) Cost: Claims; (3) Improvement Activities: Attestation, Claims, EHR Direct, QCDR, qualified registry, and CMS Web Interface; (4) Advancing care information: Attestation, EHR Direct, remove QCDR, remove qualified registry, and remove CMS Web Interface.

Response: We appreciate the feedback as we are striving to balance simplicity with flexibility. We believe that by having numerous data submission mechanisms available for selection it reduces burden to MIPS eligible clinicians. The data submission options for all MIPS eligible clinicians are outlined in this final rule with comment period in Tables 3 and 4.

Comment: Some commenters opposed the lack of transparency of the claims-based quality and cost performance category measures. The commenters recommended that CMS make the claims-based attribution of patients and diagnoses fully transparent to MIPS eligible clinicians and beneficiaries. They suggested CMS modify them so they accurately reflect each MIPS eligible clinician's contribution to quality and resource utilization.

Response: We appreciate the feedback and will take the suggestions into consideration in the future. We would like to note that information regarding claims-based quality and cost performance category measures can be found in the Appendix of this final rule with comment period under Table A through Table G under the “data submission method” tab. In addition, claims-based quality measures information may be found at QualityPaymentProgram.cms.gov.

Comment: Another commenter recommended that CMS consider allowing MIPS eligible clinicians to report across multiple QCDRs because allowing MIPS eligible clinicians to report through multiple QCDRs would permit the specificity of reporting required for diverse specialties, but without increasing the IT integration burden on MIPS eligible clinicians who might already be reporting through these registries.

Response: Many QCDRs charge their participants for collecting and reporting data. Not only might this increase the cost to MIPS eligible clinicians, but it would make the calculation of the quality score that much more cumbersome and prone to error. Errors that could occur include incorrect submission of TIN or NPI information, incomplete data for one or more measures, etc. We note, however, that MIPS eligible clinicians do have the flexibility to submit data using different submission mechanisms across the different performance categories. For example, one QCDR could report the advancing care information performance category for a particular MIPS eligible clinician, and that MIPS eligible clinician could use another QCDR to report the quality performance category.

Comment: One commenter requested that CMS clearly state the reporting requirements for each reporting mechanism for quality. The commenter noted that MIPS eligible clinicians who elect to submit four eCQMs will submit that data through a QCDR, qualified registry, or EHR with the QRDA standard that is certified, and then be restricted on their ability to use the attestation mechanism for the remaining two quality measures if they elect to submit non-eCQMs that do not require Start Printed Page 77094certification. The commenter agreed that not all submitted measures need to be eCQMs, but believed CMS needed to provide greater clarity on handling such a scenario and wanted CMS to consider the submission mechanism's ability to submit data using a single standard.

Response: The quality data submission criteria is described in section II.E.5.a.(2) of this final rule with comment period. We would like to explain that attestation is not a submission mechanism allowed for the quality performance category, rather only for the improvement activities and advancing care information performance categories. Additionally, we are finalizing our policy that MIPS eligible clinicians would need to submit data for a given performance category only one submission mechanism. We refer readers to section II.E.5.a.(2) of this final rule with comment period where we discuss our approach for the rare situations where a MIPS eligible clinician submits data for a performance category via multiple submission mechanisms (for example, submits data for the quality performance category through a registry and QCDR), and how we score those MIPS eligible clinicians. We further note that in that section we are seeking comment for further consideration on different approaches for addressing this scenario.

Comment: Some commenters agreed with the proposal of using submission methods already available in the current PQRS program because this allows QCDRs to focus on the creation of measures and adapting to final MIPS rule rather than on the submission process itself.

Response: We appreciate the commenters' support.

Comment: Several commenters noted they support the CMS goals of patient-centered health care, and the aim of the MIPS program for evidence-based and outcome-driven quality performance reporting. These commenters appreciated that the flexibility allowed in the MIPS program, including the variety of reporting options, is intended to meet the needs of the wide variety of MIPS eligible clinicians. The commenters believed, however, that the variety of reporting options can easily create confusion due to the increased number of choices and methods. Such confusion will be challenging in general, but could be especially problematic for 2017, given the short time to prepare. One commenter suggested that technical requirements for reporting options should be incorporated into CEHRT, and not added through subregulatory guidance. Another commenter stated that there are too many reporting options, and the number of options should be reduced.

Response: We appreciate the commenters' support. We have provided several data submission mechanisms to allow flexibility for the MIPS eligible clinician. It is important to note that substantive aspects of technical requirements for reporting options incorporated into CEHRT have been addressed in section II.E.g. of this final rule with comment period. However, we intend to issue subregulatory guidance regarding further details on the form and manner of EHR submission.

Comment: One commenter recommended CMS allow each specialty group within a multi-specialty practice to report its own group data file. The commenter suggested that if this cannot be done under a single TIN, then CMS should explicitly encourage multi-specialty practices that wish to report specialty-specific measure sets and improvement activities at the group level to register each specialty group under a different TIN for identification purposes. The commenter recognized that there may be operational challenges to implementing this recommendation and is willing to work with CMS and its vendors to develop the framework for the efficient collection and calculation of multiple data files for a single MIPS performance category from a group.

Response: We appreciate the commenters' recommendation and will take it into consideration in future rulemaking. We refer readers to section II.E.1.e. of this final rule with comment period for more information on groups.

After consideration of the comments on our proposals regarding the MIPS data submission mechanisms, we are modifying the data submission mechanisms at § 414.1325. We will not be finalizing the data submission mechanism of administrative claims for the improvement activities performance category, as it is not technically feasible at this time. All other data submission mechanisms will be finalized as proposed. Specifically, we are finalizing at § 414.1325(a) that MIPS eligible clinicians and groups must submit measures, objectives, and activities for the quality, improvement activities, and advancing care information performance categories.

Refer to Tables 3 and 4 of this final rule with comment period for the finalized data submission mechanisms. Table 3 contains a summary of the data submission mechanisms for individual MIPS eligible clinicians that we are finalizing at § 414.1325(b) and (e). Table 4 contains a summary of the data submission mechanisms for groups that are not reporting through an APM that we are finalizing at § 414.1325(c) and § 414.1325(e). Furthermore, we are finalizing our proposal at § 414.1325(d) that except for groups that elect to report the CAHPS for MIPS survey, MIPS eligible clinicians and groups may elect to submit information via multiple mechanisms; however, they must use the same identifier for all performance categories and they may only use one submission mechanism per performance category. In addition, we are finalizing at § 414.1305 the following definitions as proposed: (1) Attestation means a secure mechanism, specified by CMS, with respect to a particular performance period, whereby a MIPS eligible clinician or group may submit the required data for the advancing care information or the improvement activities performance categories of MIPS in a manner specified by CMS; (2) CMS-approved survey vendor means a survey vendor that is approved by CMS for a particular performance period to administer the CAHPS for MIPS survey and to transmit survey measures data to CMS; and (3) CMS Web Interface means a web product developed by CMS that is used by groups that have elected to utilize the CMS Web Interface to submit data on the MIPS measures and activities.

Table 3—Data Submission Mechanisms for MIPS Eligible Clinicians Reporting Individually as TIN/NPI

Performance category/ submission combinations acceptedIndividual reporting data submission mechanisms
QualityClaims. QCDR. Qualified registry. EHR.
CostAdministrative claims (no submission required).
Advancing Care InformationAttestation. QCDR. Qualified registry. EHR.
Improvement ActivitiesAttestation. QCDR. Qualified registry. EHR.
Start Printed Page 77095

TABLE 4—Data Submission Mechanisms for Groups

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 (no submission required).
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).

(3) Submission Deadlines

For the submission mechanisms described in the proposed rule (81 FR 28181), we proposed a submission deadline whereby all associated data for all performance categories must be submitted. In establishing the submission deadlines, we took into account multiple considerations, including the type of submission mechanism, the MIPS performance period, and stakeholder input and our experiences under the submission deadlines for the PQRS, VM, and Medicare EHR Incentive Programs.

Historically, under the PQRS, VM, or Medicare EHR Incentive Programs, the submission of data occurred after the close of the performance periods. Our experience has shown that allowing for the submission of data after the close of the performance period provides either the MIPS eligible clinician or the third party intermediary time to ensure the data they submit to us is valid, accurate and has undergone necessary data quality checks. Stakeholders have also stated that they would appreciate the ability to submit data to us on a more frequent basis so they can receive feedback more frequently throughout the performance period. We also note that, as described in the proposed rule (81 FR 28179), the MIPS performance period for payments adjusted in 2019 is CY 2017 (January 1 through December 31).

Based on the factors noted, we proposed at § 414.1325(e) that the data submission deadline for the qualified registry, QCDR, EHR, and attestation submission mechanisms would be March 31 following the close of the performance period. We anticipate that the submission period would begin January 2 following the close of the performance period. For example, for the first MIPS performance period, the data submission period would occur from January 2, 2018, through March 31, 2018. We note that this submission period is the same time frame as what is currently available to EPs and group practices under PQRS. We were interested in receiving feedback on whether it is advantageous to either (1) have a shorter time frame following the close of the performance period, or (2) have a submission period that would occur throughout the performance period, such as bi-annual or quarterly submissions; and (3) whether January 1 should also be included in the submission period. We requested comments on these items.

We further proposed that for the Medicare Part B claims submission mechanism, the submission deadline would occur during the performance period with claims required to be processed no later than 90 days following the close of the performance period. Lastly, for the CMS Web Interface submission mechanism, the submission deadline will occur during an 8-week period following the close of the performance period that will begin no earlier than January 1 and end no later than March 31. For example, the CMS Web Interface submission period could span an 8-week timeframe beginning January 16 and ending March 13. The specific deadline during this timeframe will be published on the CMS Web site.

We requested comments on these proposals.

The following is a summary of the comments we received on our proposals regarding MIPS submission deadlines.

Comment: One commenter requested clarity on the first reporting deadline.

Response: The first proposed submission deadline for the qualified registry, QCDR, EHR, and attestation submission mechanisms is from January 2nd, 2018 through March 31st, 2018. For the CMS Web Interface submission mechanism, the first proposed submission deadline will occur during an 8-week period following the close of the performance period that will begin no earlier than January 1 and end no later than March 31 (for example, January 16 through March 13, 2018). The specific deadline during this timeframe will be published on the CMS Web site.

Comment: Several commenters supported the data submission deadline of March 31 of the year following the performance period. The commenters also suggested that more frequent submissions could be useful but only if data are easy to submit. Another commenter recommended that CMS not make more frequent data submission a requirement, but allow for reporters to submit data on a more frequent basis if they so choose. The commenter saw benefit to more frequent data submission, but stated that there are some concerns CMS should consider. For example, they noted that monthly submission would not work well with the advancing care information performance category requirement that requires reporting patients' choosing to view their patient portal, as patients would have to visit the portal during the month after their appointment in order for the portal visit to count towards the measure.

Response: We appreciate the commenters' support. We intend to explore the capability of more frequent data submission to the MIPS program. As a starting point we intend to allow for optional, early data submissions for the qualified registry, QCDR, EHR, and attestation submission mechanisms. Specifically, we would allow submissions to begin earlier than January 2, 2018 for those individual MIPS eligible clinicians and groups who would like to optionally submit data early to us, if technically feasible. If it is not technically feasible to allow the submission period to begin prior to January 2 following the close of the performance period, the submission period will occur from January 2 through March 31 following the close of the performance period. Please note that the final deadline for these submission mechanisms will remain March 31, 2018. Additional details related to the technical feasibility of early data submissions will be made available at QualityPaymentProgram.cms.gov.

Comment: Some commenters were concerned about timelines for the PQRS, VM, and Medicare EHR Incentive Program for EPs. The commenters believed it was unfair to expect MIPS eligible clinicians and groups to complete full calendar year reporting in 2016 for EHR Incentive Program and PQRS and then completely switch to a new program while still completing attestations for 2016 programs.Start Printed Page 77096

Response: We understand the commenters' concerns and therefore have modified our proposed policy to allow more flexibility and time for MIPS eligible clinicians to transition to CEHRT and familiarize themselves with MIPS requirements. As discussed in section II.E.5.b.(3) of this final rule with comment period, we are finalizing the policy that MIPS clinicians will only need to report for a minimum of a continuous 90-day period within CY 2017, for the majority of the submission mechanisms for all data in a given performance category and submission mechanism, to qualify for an upward adjustment for the transition year.

Comment: Another commenter called for the elimination of reporting electronically to data registries unless the registries have been empirically demonstrated to improve care and reduce cost in practice.

Response: We appreciate the comment regarding the function of a qualified registry to improve care and reduce cost in practice. We agree that registries are a tool to drive value in clinical practice. For MIPS, a qualified registry or QCDR is required to provide attestation statements from the MIPS eligible clinicians during the data submission period that all of the data (quality measures, improvement activities, and advancing care information measures and activities, if applicable) and results are accurate and complete.

Comment: Another commenter believed that limiting performance category data submission to one mechanism per performance category will limit innovation and disincentivize reporting the highest quality data available. The commenter believed that if MIPS eligible clinicians could report some of the required quality measures through a QCDR, they should be allowed to do so. Other commenters supported CMS' proposal to retain reporting mechanisms available in PQRS but opposed the proposal to allow only one submission mechanism per performance category, especially for the quality performance category. The commenters stated that some MIPS eligible clinicians may need to report through multiple mechanisms, such as MIPS eligible clinicians reporting a proposed specialty-specific measure set containing measures requiring differing submission mechanisms. A few commenters requested that CMS reconsider its proposal that all quality measures used by CMS must be submitted from the same reporting method because there are limits in the applicable reporting methods for certain measures, with some specialty-specific measure sets having very few EHR-enabled measures. These commenters believed the MIPS eligible clinicians should be able to use multiple reporting options. Another commenter urged CMS to limit the number of measure data reporting options so hospitals, health systems, and national stewards can accurately assess and benchmark performance over time. Another commenter recommended that for at least the first 3 to 5 years of the program, the submission mechanism flexibility to report measures using a variety of mechanisms remain in place.

Response: MIPS eligible clinicians may choose whichever data submission mechanisms works best for their practice. We have provided many data submission options to allow the utmost flexibility for the MIPS eligible clinician. We believe the proposal to allow multiple mechanisms, while restricting the number of mechanisms per performance category, offers flexibility without adding undue complexity. We discuss our policies related to multiple methods of reporting within a performance category in section II.E.5.a. of this final rule with comment period. We would also like to note that in section II.E.6.a. of this final rule with comment period we are seeking comment for further consideration on additional flexibilities that should be offered for MIPS eligible clinicians in this situation.

In addition, we do not believe that allowing these various submission mechanisms impacts the ability to create reliable and accurate measure benchmarks. We discuss our policies related to measure benchmarks in more detail in section II.E.6.e. of this final rule with comment period.

Comment: One commenter recommended that CMS require Medicare Part B claims to be submitted, rather than processed, within 90 days of the close of the applicable performance period, as MIPS eligible clinicians have no control over how quickly claims are processed and should not be held responsible for delays. Another commenter recommended that the submission time period be extended to 12 weeks, as more data will be required to be submitted than historically during that time period. Other commenters expressed concern with CMS' proposed submission deadline and requested a minimum 90-day submission period as MIPS eligible clinicians employed by health systems may not have access to December data until February and cumulative data even later. The commenters further believed that submission periods should be standardized regardless of submission mechanism and suggest a submission period from January 1 through March 31. A few commenters agreed with the proposed 90-day submission period policy for submittal of data via the claims mechanism and noted that the prior deadline was often too challenging for MIPS eligible clinicians to meet.

Response: In establishing the submission deadlines, we took into account multiple considerations, including the type of submission mechanism, the MIPS performance period, and stakeholder input and our experiences under the submission deadlines for the PQRS, VM, and Medicare EHR Incentive Program. Our experience has shown that allowing for the submission of data after the close of the performance period provides either the MIPS eligible clinician or the third party intermediary time to ensure the data they submit to us is valid, accurate and has undergone necessary data quality checks. We do note, however, that as indicated previously in this final rule with comment period, we would allow submissions to begin earlier than January 2, 2018 for those individual MIPS eligible clinicians and groups who would like to optionally submit data early to us, provided that it is technically feasible. If it is not technically feasible, individual MIPS eligible clinicians and groups will still be able to submit data during the normal data submission period. Please note that the final deadline for all submission mechanisms will remain at March 31, 2018. However, for the Medicare Part B claims submission mechanism, we believe the best approach for the data submission deadline is to require Medicare Part B claims to be processed no later than 60 days following the close of the performance period.

Comment: Another commenter stated that despite MIPS data submission via the CMS Web Interface, the process of data verification prior to submission is still manual and labor-intensive. The commenter encouraged CMS to explore methods for allowing test submissions (whether throughout the performance period or during the submission window) to uncover any possible submission errors; this would provide an opportunity for CMS to give feedback to MIPS eligible clinicians and third party intermediaries in advance of the submission deadline.

Response: We appreciate the feedback and would like to note as indicated previously in this final rule with comment period, we would allow submissions to begin earlier than January 2, 2018 for those individual MIPS eligible clinicians and groups who would like to optionally submit data Start Printed Page 77097early to us, if technically feasible. If it is not technically feasible to allow the submission period to begin prior to January 2 following the close of the performance period, the submission period will occur from January 2 through March 31 following the close of the performance period. Please note that the final deadline for these submission mechanisms will remain March 31, 2018.

Comment: We received comments on our request for feedback on whether it is advantageous to either (1) have a shorter time frame following the close of the performance period, or (2) have a submission period that would occur throughout the performance period, such as bi-annual or quarterly submissions; and (3) whether January 1 should also be included in the submission period. A few commenters opposed shorter reporting timeframes for MIPS eligible clinicians using the CMS Web Interface or other reporting mechanisms. The commenters recommended, in general, quarterly or semi-annual data submission periods with a minimum report of at least once annually, and subsequently a quarterly report by CMS detailing MIPS eligible clinicians' progress. The commenters recommended a real-time tool for MIPS eligible clinicians to be able to track their MIPS progress. Another commenter stated that MIPS reporting deadlines should be no earlier than 2 months following the notification of QP status. Other commenters stated that bi-annual and quarterly submission period requirements would be advantageous only if CMS intended to provide timely MIPS eligible clinician feedback on a quarterly basis. They stated that if quarterly reporting were to be required, EHR vendors would need to have upfront notice regarding changes in measures in order to prepare. One commenter expressed that clinicians must know the standards by which they will be measured in advance of the performance period and require 3 months after the performance period to scrub data before submitting. The commenter stated that quarterly data submission would be too burdensome.

Response: We appreciate the feedback and agree with the commenter that we want to strike the right balance on allowing for more frequent submissions which would allow us to issue more frequent performance feedback, while ensuring that the process that is developed is not overly burdensome. Therefore, as indicated previously in this final rule with comment period, we would allow submissions to begin earlier than January 2, 2018 for those individual MIPS eligible clinicians and groups who would like to optionally submit data early to us, if technically feasible. If it is not technically feasible to allow the submission period to begin prior to January 2 following the close of the performance period, the submission period will occur from January 2 through March 31 following the close of the performance period. Please note that the final deadline for these submission mechanisms will remain March 31, 2018.

After consideration of the comments received on the proposals regarding MIPS submission deadlines, we are finalizing the submission deadlines as proposed with one modification. Specifically, we are finalizing at § 414.1325(f) the data submission deadline for the qualified registry, QCDR, EHR, and attestation submission mechanisms as March 31 following the close of the performance period. The submission period will begin prior to January 2 following the close of the performance period, if technically feasible. For example, for the first MIPS performance period, the data submission period will occur prior to January 2, 2018, through March 31, 2018, if technically feasible. If it is not technically feasible to allow the submission period to begin prior to January 2 following the close of the performance period, the submission period will occur from January 2 through March 31 following the close of the performance period. In any case, the final deadline will remain March 31, 2018.

We further finalize at § 414.1325(f)(2) that for the Medicare Part B claims submission mechanism, the submission deadline must be on claims with dates of service during the performance period that must be processed no later than 60 days following the close of the performance period. Lastly, for the CMS Web Interface submission mechanism, we are finalizing at § 414.1325(f)(3) the submission deadline must be an 8-week period following the close of the performance period that will begin no earlier than January 1, and end no later than March 31. For example, the CMS Web Interface submission period could span an 8-week timeframe beginning January 16 and ending March 13. The specific deadline during this timeframe will be published on the CMS Web site.

b. Quality Performance Category

(1) Background

(a) General Overview and Strategy

The MIPS program is one piece of the broader health care infrastructure needed to reform the health care system and improve health care quality, efficiency, and patient safety for all Americans. We seek to balance the sometimes competing considerations of the health system and minimize burdens on health care providers given the short timeframe available under the MACRA for implementation. Ultimately, MIPS should, in concert with other provisions of the Act, support health care that is patient-centered, evidence-based, prevention-oriented, outcome driven, efficient, and equitable.

Under MIPS, clinicians are incentivized to engage in improvement measures and activities that have a proven impact on patient health and safety and are relevant to their patient population. We envision a future state where MIPS eligible clinicians will be seamlessly using their certified health IT to leverage advanced clinical quality measurement to manage patient populations with the least amount of workflow disruption and reporting burden. Ensuring clinicians are held accountable for patients' transitions across the continuum of care is imperative. For example, when a patient is discharged from an emergency department (ED) to a primary care physician office, health care providers on both sides of the transition should have a shared incentive for a seamless transition. Clinicians may also be working with a QCDR to abstract and report quality measures to CMS and commercial payers and to track patients longitudinally over time for quality improvement.

Ideally, clinicians in the MIPS program will have accountability for quality and cost measures that are related to one another and will be engaged in improvement activities that directly help them improve in both specialty-specific clinical practice and more holistic areas (for example, patient experience, prevention, population health). The cost performance category will provide clinicians with information needed to delivery efficient, effective, and high-value care. Finally, MIPS eligible clinicians will be using CEHRT and other tools which leverage interoperable standards for data capture, usage, and exchange in order to facilitate and enhance patient and family engagement, care coordination among diverse care team members, and continuous learning and rapid-cycle improvement leveraging advanced quality measurement and safety initiatives.

One of our goals in the MIPS program is to use a patient-centered approach to program development that will lead to better, smarter, and healthier care. Part of that goal includes meaningful Start Printed Page 77098measurement which we hope to achieve through:

  • Measuring performance on measures that are relevant and meaningful.
  • Maximizing the benefits of CEHRT.
  • Flexible scoring that recognizes all of a MIPS eligible clinician's efforts above a minimum level of effort and rewards performance that goes above and beyond the norm.
  • Measures that are built around real clinical workflows and data captured in the course of patient care activities.
  • Measures and scoring that can discern meaningful differences in performance in each performance category and collectively between low and high performers.

(b) The MACRA Requirements

Sections 1848(q)(1)(A)(i) and (ii) of the Act require the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards and, using that methodology, to provide for a final score for each MIPS eligible clinician. Section 1848(q)(2)(A)(i) of the Act requires us to use the quality performance category in determining each MIPS eligible clinician's final score, and section 1848(q)(2)(B)(i) of the Act describes the measures and activities that must be specified under the quality performance category.

The statute does not specify the number of quality measures on which a MIPS eligible clinician must report, nor does it specify the amount or type of information that a MIPS eligible clinician must report on each quality measure. However, section 1848(q)(2)(C)(i) of the Act requires the Secretary, as feasible, to emphasize the application of outcomes-based measures.

Sections 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs, and section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary to encourage the use of CEHRT and QCDRs for reporting measures under the quality performance category under the final score methodology, but the statute does not limit the Secretary's discretion to establish other reporting mechanisms.

Section 1848(q)(2)(C)(iv) of the Act generally requires the Secretary to give consideration to the circumstances of non-patient facing MIPS eligible clinicians and allows the Secretary, to the extent feasible and appropriate, to apply alternative measures or activities to such clinicians.

(c) Relationship to the PQRS and VM

Previously, the PQRS, which is a pay-for-reporting program, defined requirements for satisfactory reporting and satisfactory participation to earn payment incentives or to avoid a PQRS payment adjustment EPs could choose from a number of reporting mechanisms and options. Based on the reporting option, the EP had to report on a certain number of measures for a certain portion of their patients. In addition, the measures had to span a set number of National Quality Strategy (NQS) domains, information related to the NQS can be found at http://www.ahrq.gov/​workingforquality/​about.htm. The VM built its policies off the PQRS criteria for avoiding the PQRS payment adjustment. Groups that did not meet the criteria as a group to avoid the PQRS payment adjustment or groups that did not have at least 50 percent of the EPs that did not meet the criteria as individuals to avoid the PQRS payment adjustment automatically received the maximum negative adjustment established under the VM and are not measured on their quality performance.

MIPS, in contrast to PQRS, is not a pay-for-reporting program, and we proposed that it would not have a “satisfactory reporting” requirement. However, to develop an appropriate methodology for scoring the quality performance category, we believe that MIPS needs to define the expected data submission criteria and that the measures need to meet a data completeness standard. In the proposed rule (81 FR 28184), we proposed the minimum data submission criteria and data completeness standard for the MIPS quality performance category for the submission mechanisms that were discussed in the proposed rule (81 FR 28181), as well as benchmarks against which eligible clinicians' performance would be assessed. The scoring methodology discussed in the proposed rule (81 FR 28220) would adjust the quality performance category scores based on whether or not an individual MIPS eligible clinician or group met these criteria and how their performance compared against the benchmarks.

In the MIPS and APMs RFI, we requested feedback on numerous provisions related to data submission criteria including: How many measures should be required? Should we maintain the policy that measures cover a specified number of NQS domains? How do we apply the quality performance category to MIPS eligible clinicians that are in specialties that may not have enough measures to meet our defined criteria? Several themes emerged from the comments. Commenters expressed concern that the general PQRS satisfactory reporting requirement to report nine measures across three NQS domains is too high and forces eligible clinicians to report measures that are not relevant to their practices. The commenters requested a more meaningful set of requirements that focused on patient care, with some expressing the opinion that NQS domain requirements are arbitrary and make reporting more difficult. Some commenters requested that we align measures across payers and consider using core measure sets. Other commenters expressed the need for flexibility and different reporting options for different types of practices.

In response to the MIPS and APMs RFI comments, and based on our desire to simplify the MIPS reporting system and make the measurement more meaningful, we proposed MIPS quality criteria that focus on measures that are important to beneficiaries and maintain some of the flexibility from PQRS, while addressing several of the issues that concerned commenters.

  • To encourage meaningful measurement, we proposed to allow individual MIPS eligible clinicians and groups the flexibility to determine the most meaningful measures and reporting mechanisms for their practice.
  • To simplify the reporting criteria, we are aligning the submission criteria for several of the reporting mechanisms.
  • To reduce administrative burden and focus on measures that matter, we are lowering the expected number of the measures for several of the reporting mechanisms, yet are still requiring that certain types of measures be reported.
  • To create alignment with other payers and reduce burden on MIPS eligible clinicians, we are incorporating measures that align with other national payers.
  • To create a more comprehensive picture of the practice performance, we also proposed to use all-payer data where possible.

As beneficiary health is always our top priority, we proposed criteria to continue encouraging the reporting of certain measures such as outcome, appropriate use, patient safety, efficiency, care coordination, or patient experience measures. However, we proposed to remove the requirement for measures to span across multiple domains of the NQS. We continue to believe the NQS domains to be extremely important and we encourage MIPS eligible clinicians to continue to strive to provide care that focuses on: effective clinical care, communication, Start Printed Page 77099efficiency and cost reduction, person and caregiver-centered experience and outcomes, community and population health, and patient safety. While we will not require that a certain number of measures must span multiple domains, we encourage MIPS eligible clinicians to select measures that cross multiple domains. In addition, we believe the MIPS program overall, with the focus on cost, improvement activities, and advancing care information performance categories, will naturally cover many elements in the NQS.

(2) Contribution to the Final Score

For the 2019 MIPS adjustment year, the quality performance category will account for 50 percent of the final score, subject to the Secretary's authority to assign different scoring weights under section 1848(q)(5)(F) of the Act. Section 1848(q)(2)(E)(i)(I)(aa) of the Act states the quality performance category will account for 30 percent of the final score for MIPS. However, section 1848(q)(2)(E)(i)(I)(bb) of the Act stipulates that for the first and second years for which MIPS applies to payments, the percentage of the final score applicable for the quality performance category will be increased so that the total percentage points of the increase equals the total number of percentage points by which the percentage applied for the cost performance category is less than 30 percent. Section 1848(q)(2)(E)(i)(II)(bb) of the Act requires that, for the transition year for which MIPS applies to payments, not more than 10 percent of the of final score shall be based on performance to the cost performance category. Furthermore, section 1848(q)(2)(E)(i)(II)(bb) of the Act states that, for the second year for which MIPS applies to payments, not more than 15 percent of the final score shall be based on performance to the cost performance category. We proposed at § 414.1330 for payment years 2019 and 2020, 50 percent and 45 percent, respectively, of the MIPS final score would be based on performance on the quality performance category. For the third and future years, 30 percent of the MIPS final score would be based on performance on the quality performance category.

Section 1848(q)(5)(B)(i) of the Act requires the Secretary to treat any MIPS eligible clinician who fails to report on a required measure or activity as achieving the lowest potential score applicable to the measure or activity. Specifically, under our proposed scoring policies, a MIPS eligible clinician or group that reports on all required measures and activities could potentially obtain the highest score possible within the performance category, presuming they performed well on the measures and activities they reported. A MIPS eligible clinician or group who does not meet the reporting threshold would receive a zero score for the unreported items in the category (in accordance with section 1848(q)(5)(B)(i) of the Act). The MIPS eligible clinician or group could still obtain a relatively good score by performing very well on the remaining items, but a zero score would prevent the MIPS eligible clinician or group from obtaining the highest possible score.

The following is summary of the comments we received regarding our general strategy and the quality performance category contribution to the final score.

Comment: Numerous commenters supported the focus on quality in the proposed rule and our proposal that, for payment year 2019, 50 percent of the final score would be based on performance on quality measures.

Response: We thank the commenters for their support.

Comment: Other commenters were concerned with the quality performance category's final score weights decreasing to 30 percent for payment years 2021 and beyond, as some eligible clinicians will not be eligible to participate in MIPS and receive a MIPS adjustment until payment year 2021. The commenters believed this would be a disadvantage with the cost performance category final score weight increasing. The commenters noted that increasing penalties under MIPS would also place such clinicians in an unfair position. The commenters requested that CMS make appropriate considerations for such MIPS eligible clinicians.

Response: We appreciate the concerns raised that MIPS eligible clinicians who are not initially eligible to participate in MIPS and receive MIPS adjustments until payment year 2021 might have a different starting point than those MIPS eligible clinicians who begin participating in CY 2017. We note that those MIPS eligible clinicians who are not initially eligible to participate in MIPS and receive MIPS adjustments, do have the option to volunteer to report. By volunteering to report, these eligible clinicians will gain experience with the MIPS scoring system prior to being required to do so. We will, however, take the commenter's recommendation into consideration for future rulemaking.

Comment: Another commenter requested that when the time comes to include rehabilitation therapists in MIPS program, they be granted the same stepped-down percentage of scoring for quality and stepped-up percentage of scoring for cost that are in place for those MIPS eligible clinicians participating in MIPS program in the first 2 years. Such an approach would give those MIPS eligible clinicians the same time and consideration doctors of medicine or osteopathy, doctors of dental surgery or dental medicine, physician assistants, nurse practitioners, clinical nurse specialists, and certified registered nurse anesthetists will receive during their transition to MIPS program.

Response: We would like to explain that in the first 2 years of the MIPS program, the quality weight will be higher and the cost weight will be lower. In addition, we note that those MIPS eligible clinicians who are not initially eligible to participate in MIPS in 2017 for the 2019 MIPS payment year, do have the option to voluntarily report. By volunteering to report, these eligible clinicians will gain experience with the MIPS scoring system prior to being required to do so. We thank the commenter for their feedback and will take their comments into consideration in future rulemaking.

Comment: One commenter supported CMS' proposal to incentivize MIPS eligible clinicians to use CEHRT for end-to-end electronic reporting.

Response: We thank the commenter for their support.

Comment: One commenter stated they were concerned about how different evaluation criteria have been weighed in the MIPS program. They believed there was an arbitrary nature and bias in the weighting for MIPS which they stated cannot be corrected through a change in weighting. The commenter provided an example of the scoring system including bonus points, which they believed results in an inaccurate view of real outcomes.

Response: We do not believe that the evaluation criteria we have developed and proposed for MIPS are arbitrary or biased. Moreover, as we explained in the proposed rule (81 FR 28255), bonus points are intended to recognize quality measurement priorities. We believe that recognition is necessary to focus quality improvement efforts on specific CMS goals.

Comment: Another commenter suggested for the quality performance measures that CMS adopt standards and mapping tools by ensuring that eCQM calculations are accurate. In addition, the commenter stated CMS should adopt standards to ensure different EHRs are accurately and uniformly capturing eCQMs. Another commenter recommended that CMS ensure that the eCQMs in the quality performance category align with measures used by Start Printed Page 77100other payers and accrediting and certification programs (for example, NCQA), noting that if the specifications do not align, the commenter believed that shared data will not help streamline the reporting processes.

Response: We thank the commenters and agree that adopting standards to accurately and uniformly capture eCQMs is essential. We currently use the Health Level Seven (HL7) standard Health Quality Measures Format (HQMF) for electronically documenting eCQM content as well as the Quality Data Model (QDM) for measure logic. We will continue to ensure industry standards are used and refined in order best capture eCQM data.

Comment: One commenter recommended that CMS consider merging the quality and cost performance categories as a ratio of quality and cost.

Response: We do not believe we have the statutory authority to merge the quality and cost performance categories. MACRA specified the four performance categories we are required to incorporate into the MIPS program.

After consideration of the comments received regarding our general strategy and the quality performance category contribution to the final score and the additional factors described in section II.E.5.b. of this final rule with comment period, we are not finalizing this policy as proposed. Rather, as discussed in section II.E.5.e. of this final rule with comment period, the cost performance category will account for 0 percent of the final score in 2019, 10 percent of the final score in 2020, and 30 percent of the final score in 2021 and future MIPS payment years, as required by statute. In accordance with section 1848(q)(2)(E)(i)(I)(bb) of the Act, we are redistributing the final score weight from cost performance category to the quality performance category. Therefore, we are finalizing at § 414.1330(b) for MIPS payment years 2019 and 2020, 60 percent and 50 percent, respectively, of the MIPS final score will be based on performance on the quality performance category. For the third and future years, 30 percent of the MIPS final score will be based on performance on the quality performance category.

(3) Quality Data Submission Criteria

(a) Submission Criteria

The following are the proposed criteria for the various proposed MIPS data submission mechanisms described in the proposed rule (81 FR 28181) for the quality performance category.

(i) Submission Criteria for Quality Measures Excluding CMS Web Interface and CAHPS for MIPS

We proposed at § 414.1335 that individual MIPS eligible clinicians submitting data via claims and individual MIPS eligible clinicians and groups submitting via all mechanisms (excluding CMS Web Interface, and for CAHPS for MIPS survey, CMS-approved survey vendors) would be required to meet the following submission criteria. We proposed that for the applicable 12-month performance period, the MIPS eligible clinician or group would report at least six measures including one cross-cutting measure (if patient-facing) found in Table C of the Appendix in this final rule with comment period and including at least one outcome measure. If an applicable outcome measure is not available, we proposed that the MIPS eligible clinician or group would be required to report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. If fewer than six measures apply to the individual MIPS eligible clinician or group, then we proposed the MIPS eligible clinician or group would be required to report on each measure that is applicable.

MIPS eligible clinicians and groups would select their measures from either the list of all MIPS measures in Table A of the Appendix in this final rule with comment period, or a set of specialty-specific measure set in Table E of the Appendix in this final rule with comment period. We noted that some specialty-specific measure sets include measures grouped by subspecialty; in these cases, the measure set is defined at the subspecialty level.

We designed the specialty-specific measure sets to address feedback we have received in the past that the quality measure selection process can be confusing. A common complaint about PQRS was that EPs were asked to review close to 300 measures to find applicable measures for their specialty. The specialty measure sets in Table E of the Appendix in this final rule with comment period, are the same measures that are within Table A of the Appendix in this final rule with comment period, however these are sorted consistent with the American Board of Medical Specialties (ABMS) specialties. Please note that these specialty-specific measure sets are not all inclusive of every specialty or subspecialty. We requested comments on the measures proposed under each of the specialty-specific measure sets. Specifically, we solicited comments on whether or not the measures proposed for inclusion in the specialty-specific measure sets are appropriate for the designated specialty or subspecialty and whether there are additional proposed measures that should be included in a particular specialty-specific measure set.

Furthermore, in the proposed rule we noted that there were some special scenarios for those MIPS eligible clinicians who selected their measures from a specialty-specific measure set at either the specialty or subspecialty level (Table E of the Appendix in this final rule with comment period). We provided the following example in the proposed rule, where some of the specialty-specific measure sets have fewer than six measures, in these instances MIPS eligible clinicians would report on all of the available measures including an outcome measure or, if an outcome measure is unavailable, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures), within the set and a cross-cutting measure if they are a patient-facing MIPS eligible clinician. To illustrate, at the subspecialty-level the electrophysiology cardiac specialist specialty-specific measure set only has three measures within the set, all of which are outcome measures. MIPS eligible clinicians and groups reporting on the electrophysiology cardiac specialist specialty-specific measure set would report on all three measures and since these MIPS eligible clinicians are patient-facing they must also report on a cross-cutting measure which is defined in Table C of the Appendix in this final rule with comment period. In other scenarios, the specialty-specific measure sets may have six or more measures, and in these instances MIPS eligible clinicians would report on at least six measures including at least one cross-cutting measure and at least one outcome measure or, if an outcome measure is unavailable, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measure). Specifically, the general surgery specialty-specific measure set has eight measures within the set, including four outcome measures, three other high priority measures and one process measure. MIPS eligible clinicians and groups reporting on the general surgery specialty-specific measure set would either have the option to report on all measures within the set or could select six measures from the set and since these MIPS eligible clinicians are patient-facing one of their Start Printed Page 77101six measures must be a cross-cutting measure which is defined in Table C of the Appendix in this final rule with comment period.

As noted above, the submission criteria is provided for each specialty-specific measure set, or in the measure set defined at the subspecialty level, if applicable. Regardless of the number of measures that are contained in a specialty-specific measure set, MIPS eligible clinicians reporting on a measure set would be required to report at least one cross-cutting measure and either at least one outcome measure or, if no outcome measures are available in that specialty-specific measure set, report another high priority measure. We proposed that MIPS eligible clinicians or groups that report on a specialty-specific measure set that includes more than six measures can report on as many measures as they wish as long as they meet the minimum requirement to report at least six measures, including one cross-cutting measure and one outcome measure, or if an outcome measure is not available another high priority measure. We solicited comment on our proposal to allow reporting of specialty-specific measure sets to meet the submission criteria for the quality performance category, including whether it is appropriate to allow reporting of a measure set at the subspecialty level to meet such criteria, since reporting at the subspecialty level would require reporting on fewer measures.

Alternatively, we solicited comment on whether we should only consider reporting up to six measures at the higher overall specialty level to satisfy the submission criteria. We noted that our proposal to allow reporting of specialty-specific measure sets at the subspecialty level was intended to address the fact that very specialized clinicians who may be represented by our subspecialty categories may only have one or two applicable measures. Further, we note that we will continue to work with specialty societies and other measure developers to increase the availability of applicable measures for specialists across the board.

We proposed to define a high priority measure at § 414.1305 as an outcome, appropriate use, patient safety, efficiency, patient experience, or care coordination quality measures. These measures are identified in Table A of the Appendix in this final rule with comment period. We further note that measure types listed as an “intermediate outcome” are considered outcome measures for the purposes of scoring (see 81 FR 28247).

As an alternative to the above proposals, we also considered requiring individual MIPS eligible clinicians submitting via claims and individual MIPS eligible clinicians and groups submitting via all mechanisms (excluding the CMS Web Interface and, for CAHPS for MIPS survey, CMS-approved survey vendors) to meet the following submission criteria. For the applicable 12-month performance period, the MIPS eligible clinician or group would report at least six measures including one cross-cutting measure (if patient-facing) found in Table C of the Appendix in this final rule with comment period and one high priority measure (outcome, appropriate use, patient safety, efficiency, patient experience, and care coordination measures). If fewer than six measures apply to the individual MIPS eligible clinician or group, then the MIPS eligible clinician or group must report on each measure that is applicable. MIPS eligible clinicians and groups will have to select their measures from either the list of all MIPS Measures in Table A of the Appendix in this final rule with comment period or a set of specialty-specific measure set in Table E of the Appendix in this final rule with comment period.

As discussed in the proposed rule (81 FR 28173), MIPS eligible clinicians who are non-patient facing MIPS eligible clinicians would not be required to report any cross-cutting measures. For further details on non-patient facing MIPS eligible clinician discussions, we refer readers to section II.E.1.b. of this final rule with comment period.

In addition, in the proposed rule (81 FR 28187) we discussed our intention to develop a validation process to review and validate a MIPS eligible clinician's or group's ability to report on at least six quality measures, or a specialty-specific measure set, with a sufficient sample size, including at least one cross-cutting measure (if the MIPS eligible clinician is patient-facing) and either an outcome measure if one is available or another high priority measure. If a MIPS eligible clinician or group had the ability to report on the minimum required measures with sufficient sample size and elects to report on fewer than the minimum required measures, then, as described in the proposed scoring algorithm (81 FR 28254), the missing measures would be scored with a zero performance score.

Our proposal is a decrease from the 2016 PQRS requirement to report at least nine measures. In addition, as previously noted, we proposed to no longer require reporting across multiple NQS domains. We believed these proposals were the best approach for the quality performance category because they decrease the MIPS eligible clinician's reporting burden while focusing on more meaningful types of measures.

We also note that we believe that outcome measures are more valuable than clinical process measures and are instrumental to improving the quality of care patients receive. To keep the emphasis on such measures in the statute, we plan to increase the requirements for reporting outcome measures over the next several years through future rulemaking, as more outcome measures become available. For example, we may increase the required number of outcome measures to two or three. We also believe that appropriate use, patient experience, safety, and care coordination measures are more relevant than clinical process measures for improving care of patients. Through future rulemaking, we plan to increase the requirements for reporting on these types of measures over time.

In consideration of which MIPS measures to identify as reasonably focused on appropriate use, we have selected measures which focus on minimizing overuse of services, treatments, or the related ancillary testing that may promote overuse of services and treatments. We have also included select measures of underuse of specific treatments or services that either (1) reflected overuse of alternative treatments and services that were are not evidence-based or supported by clinical guidelines; or (2) where the intent of the measure reflected overuse of alternative treatments and services that were not evidence-based or supported by clinical guidelines. We realize there are differing opinions on what constitutes appropriate use. Therefore, we solicited comments on what specific measures of over or under use should be included as appropriate use measures.

We plan to incorporate new measures as they become available and will give the public the opportunity to comment on these provisions through future notice and comment rulemaking. Under the Improving Medicare Post-Acute Transformation (IMPACT) Act of 2014, the Office of ASPE has been conducting studies on the issue of risk adjustment for sociodemographic factors on quality measures and cost, as well as other strategies for including SDS evaluation in CMS programs. We will closely examine the ASPE studies when they are available and incorporate findings as feasible and appropriate through future rulemaking. We look forward to working with stakeholders in this process. In Start Printed Page 77102addition, we solicited comments on ways to minimize potential gaming, for example, requiring MIPS eligible clinicians to report only on measures for which they have a sufficient sample size, to address concerns that MIPS eligible clinicians may solely report on measures that do not have a sufficient sample size to decrease the overall weight on their quality score. More information on the way we proposed to score MIPS eligible clinicians in this scenario is discussed in the proposed rule (81 FR 28187). We also solicited comment on whether these proposals sufficiently encourage clinicians and measure developers to move away from clinical process measures and towards outcome measures and measures that reflect other NQS domains. We requested comments on these proposals.

The following is summary of the comments we received regarding our proposal on submission criteria for quality measures excluding CMS Web Interface and CAHPS for MIPS.

Comment: Many commenters expressed support for lowering the reporting threshold from nine to six quality measures, including one cross-cutting and one outcome measure, and no longer requiring that MIPS eligible clinicians report on measures that span three NQS domains.

Response: We thank the commenters for their support.

Comment: Another commenter appreciated the decreased requirement relative to PQRS of reporting on six quality measures for MIPS; however, the commenter was disappointed about our proposal to maintain an absolute minimum number of measures that MIPS eligible clinicians are required to report. The commenter believed that the current quality measures list is insufficient to cover all practice types. The commenter stated that the challenge of participating would only be exacerbated by imposition of a minimum number of measures. The commenter appreciated the lack of penalty if a MIPS eligible clinician is unable to report on the minimum requirement when they do not have applicable measures. A few commenters noted that emergency clinicians who report via claims cannot report on six measures. They stated that it was not clear from proposal whether these MIPS eligible clinicians would still be able to qualify for the full potential score available under the scoring methodology. Another commenter requested CMS provide special consideration be given to clinicians practicing at urgent care centers, including reducing the required number of quality measures to report on from six to four.

Response: We would like to note that MIPS eligible clinicians with fewer than six applicable measures are not required to report six measures, and must only report those measures that are applicable. While claims-based reporting is one submission mechanism available, emergency clinicians also have the option to use the other submission mechanisms available to satisfy the requirements. We further note that we have revised the emergency medicine specialty-specific measure set whereby the set now includes 17 measures with 11 of them reportable via claims. Emergency medicine clinicians will be able to report measures to earn the full potential score.

Comment: Some commenters disagreed with our proposed measure threshold of six measures, and recommended maintaining the PQRS threshold of reported measures at nine. These commenters were concerned that lowering the threshold of reported measures (from nine to six) sends the wrong signal about the importance of quality measures within MIPS. The commenters believed MIPS eligible clinicians might pick and choose measures that they perform well on, providing a less comprehensive picture of quality of care. Instead, the commenters stated CMS should establish mandatory core sets of measures by specialty/subspecialty groups to signal areas where MIPS eligible clinicians should focus their attention and increase comparability across MIPS eligible clinicians. Other commenters believed a core set of measures would create unequal performance by groups of different sizes and specialties, allowing single specialty groups to report only measures specific to their practice. The commenters recommended that CMS establish benchmarks for a set of core quality measures.

Conversely, other commenters disagreed with our proposed measure threshold of six measures, and recommended that the measure threshold be lowered. Recommendations ranged from four measures, three measures or one to two measures. These commenters indicated that a reduced threshold would allow MIPS eligible clinicians to choose a few measures that will have a high impact on care improvements. Additionally, commenters were concerned that the threshold of six may burden practices that are struggling to find relevant measures and jeopardize their ability to achieve the maximum number of points under the quality performance category. The commenters stated that fewer required measures will reduce administrative burden, better reflect the conditions and realities of medical practice, allow MIPS eligible clinicians time to focus on quality improvement, and lead to more accurate measurement and a better snapshot of quality. Some commenters requested that CMS, the Department of Health (DOH), The Joint Commission (TJC), and Det Norske Veritas (DNV) join forces to focus on meaningful improvement.

Response: We do not believe the thresholds for quality measurement should be lowered further. In any quality measurement program, we must balance the data collection burden that we must impose on MIPS eligible clinicians with the resulting quality performance data that we will receive. We believe that without sufficiently robust performance data, we cannot accurately measure quality performance. Therefore, we believe that we have appropriately struck a balance between requiring sufficient quality measure data from clinicians and ensuring robust quality measurement at this time. We want to emphasize that we are committed to working with stakeholders to improve our quality programs including MIPS. An integral part of these programs are quality measures that reflect the scope and variety of the many types of clinical practice. It is important that we offer enough quality measures that assess the various practice types and that clinicians report sufficient measures to allow a reasonable comparison of their quality performance.

We do note that for the initial performance period under the MIPS many flexibilities have been implemented, including a modified scoring approach which ensures that MIPS eligible clinicians who prefer to only submit data on one or two measures can avoid a negative MIPS adjustment. Furthermore, our modified scoring approach incentivizes high performers who have a robust data set available. We refer readers to section II.E.6. of this final rule with comment period for more details on the scoring approach.

Comment: Another commenter referenced our proposal, which stated that “if fewer than six measures apply to the individual MIPS eligible clinician or group, then the MIPS eligible clinician or group would be required to report on each measure that is applicable,” and mentioned that this statement seemed to provide no penalty. The commenter requested clarification on this language to ensure that groups would not be penalized for submitting Start Printed Page 77103fewer than six measures. Another commenter requested clarification on how CMS proposes to define “applicable.” One commenter suggested that MIPS eligible clinicians should have the opportunity to pre-certify with CMS that fewer than six measures are available to them prior to the beginning of the performance period.

Response: While we expect this to occur in only rare circumstances, we would like to confirm the commenter's understanding. If fewer than six measures apply to the MIPS eligible clinician or group, the MIPS eligible clinician or group would be required to report on each applicable measure. Additionally, groups that report on a specialty-specific measure set that has fewer than six measures would only need to report the measures within that specialty-specific measure set. Generally, we define “applicable” to mean measures relevant to a particular MIPS eligible clinician's services or care rendered. The MIPS eligible clinician should be able to review the measure specifications to see if their services fall into the denominator of the measure. For example, if a MIPS eligible clinician who is an interventional radiologist decides to submit data via a specialty-specific measure set by selecting the interventional radiology specialty-specific measure sets, this MIPS eligible clinician would not have six measures applicable to them. Therefore, the MIPS eligible clinician would submit data on all of the measures defined within the specialty-specific measure set. MIPS eligible clinicians who do not have six individual measures available to them should select their appropriate specialty-specific measure set, because that pre-defines which measures are applicable to their specialty and provides certain assurances to them. For the majority of MIPS eligible clinicians choosing the specialty-specific measure sets provides a means to select applicable measures and, if the set includes less than 6 measures, this also assures that there is no need to report any additional measures. Furthermore, we will apply a clinical relation test to the quality data submissions to determine if the MIPS eligible clinician could have reported other measures. For more information on the clinical relation test, see section II.E.6.a.(2) of this final rule with comment period, where we discuss our validation process. Lastly, we are working to provide additional toolkits and educational materials to MIPS eligible clinicians prior to the performance period that will ease the burden on identification of which measures are applicable to MIPS eligible clinicians. If the MIPS eligible clinician required assistance, they may contact the Quality Payment Program Service Center.

Comment: Another commenter requested that CMS add a requirement that MIPS-eligible clinicians report at least six measures, including one cross-cutting measure (if patient-facing), at least one outcome measure, and at least one high-priority measure. The commenter was concerned that high-priority measures may not be reported if they are a substitute for outcome measures.

Response: We agree with the commenter that we want to maintain an emphasis on both outcome and high priority measures within the MIPS. We will take this comment into consideration for future rulemaking.

Comment: Numerous commenters supported the proposal to encourage reporting of outcome measures over clinical process measures. One commenter noted that significant work remains to ensure measurement efforts across the health care system are focused on the most important quality issues, while other commenters recommended that future quality metrics emphasize patient care and health outcomes.

Response: We thank the commenters for their support. We intend to finalize our proposal that one of the six measures a MIPS eligible clinicians must report on is an outcome measure.

Comment: One commenter recommended that patient experience and patient satisfaction should not be categorized as quality metrics since these measures and surveys include factors outside the control of the clinician. The commenter stated that patient satisfaction, while important, does not always correlate with better clinical outcomes and may even conflict with clinically indicated treatments. In addition, another commenter expressed concern that the emphasis on patient opinions and their care experiences drives up cost.

Response: We do believe it is important to assess patient experience of care, as it represents items such as communication and family engagement, which are important factors of the health care experience and these are measures that are important to patients and families. While patient experience may not always be directly related to health outcomes, there is evidence of a correlation between higher scores on patient experience surveys and better health outcomes. Please refer to http://www.ahrq.gov/​cahps/​consumer-reporting/​research/​index.html for more information on AHRQ studies pertaining to patient experience survey and better health outcomes.

Comment: A few commenters supported the proposed reduction in burden in the MIPS quality performance category, but noted that MIPS eligible clinician specialties lacking validated outcome measures or “high priority” measures are likely to be at a disadvantage under this performance category because the quality performance category lacks sufficient specialty-specific quality measures. The commenters recommended that CMS work with specialty societies and measure development bodies to increase the availability of specialty-specific quality measure sets. Another commenter supported the reduced number of quality measures required for reporting, but recommended that specialty MIPS eligible clinicians not be required to report a cross-cutting measure. Some commenters supported CMS's proposal to allow the reporting of specialty and subspecialty specific measure sets to meet the submission criteria for the quality performance category, even if it would mean a MIPS eligible clinician or group would report on fewer than six measures.

Response: We thank the commenters for their feedback. We believe that all MIPS eligible clinicians regardless of their specialty have a high priority measure available. Therefore, we intend to finalize that if a MIPS eligible clinician does not have an outcome measure available, they are required to report on a high priority measure.

Comment: Several commenters recommended eliminating the proposed requirement that an outcome measure and a cross-cutting measure be reported in the quality performance category. One commenter believed this proposal may disadvantage small or rural practices and posed challenges for QCDRs. The commenter noted that some approved QCDRs do not incorporate value codes in their data collection process, and many specialized QCDRs may not capture the data needed to report cross-cutting measures. The commenter believed the requirement for reporting on cross cutting measures also makes the 90 percent reporting threshold for QCDRs nearly impossible to meet. Another commenter stated that, until more valid and reliable outcome measures are developed, CMS should keep flexibility of measures throughout and lift the requirements that certain types of measures be reported, such as outcomes-based or cross-cutting measures. Other commenters recommended that specialty-specific measure sets lacking outcome measures be clearly marked as such and also Start Printed Page 77104contain notations as to which measures would qualify as high-priority alternatives. Several commenters recommended CMS provide bonus points for these measures rather than require all participants to report on them, and that CMS not require use of any specific measure types in the initial years of the program.

Response: We appreciate the comments and have examined the policies very carefully. We have modified our proposal for the transition year of MIPS and are finalizing that for the applicable performance period, the MIPS eligible clinician or group would report at least six measures including at least one outcome measure. If an applicable outcome measure is not available, the MIPS eligible clinician or group would be required to report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. If fewer than six measures apply to the individual MIPS eligible clinician or group, then the MIPS eligible clinician or group would be required to report on each measure that is applicable. We note that generally, we define “applicable” to mean measures relevant to a particular MIPS eligible clinician's services or care rendered.

We are not finalizing the requirement that one of the measures must be a cross-cutting measure. Although we still believe that the concept of having a common set of measures available to clinicians that they can draw from is important we understand that not all of these measures are the most meaningful to clinicians and their scope of practice. We do strongly recommend however that where appropriate, clinicians continue to perform and submit data on these measures to CMS. Lastly, while we recognize that there are limitations in the current set of available outcome measures, we believe that a strong emphasis on outcome-based measurement is critical to improving the quality of care. Due to these limitations in the available outcome measure set, we are finalizing that MIPS eligible clinician may select another high priority measure if an outcome is not available.

Comment: A few commenters recommended that CMS provide a “safe harbor” for reporting on new quality measures with innovative approaches and improvement by allowing entities to register “test measures” which would not be scored on but would count as a subset of the six quality measures with a participation credit. In addition, the commenters stated that CMS should provide a transitional period during the first half of 2017 in which MIPS eligible clinicians can receive written confirmation from CMS that their intended measures meet the requirements. The commenter expressed concern that CMS needs to provide specifications and a scoring methodology for the population health measures to improve transparency.

Response: As noted in other sections of this final rule with comment period, we are providing a transitional year for the first performance period under the MIPS. We also note that commenters successfully reporting an appropriate specialty-specific measure set for a sufficient portion of their beneficiary population will have met all minimum reporting requirements for the quality category. We appreciate the commenter's feedback and will incorporate their suggestion as we develop toolkits and educational materials. We refer the commenter to section II.E.5.b.(6) and II.E.6. of this final rule with comment period for information on population health measures and the MIPS scoring methodology respectively.

Comment: Another commenter urged CMS to pursue the following policies in the quality performance category: The commenter urged CMS to reconsider its proposal to require reporting on a minimum of six measures, if six measures apply. Instead, CMS should encourage the use of non-MIPS measures associated with a QCDR and/or allow MIPS eligible clinicians to select measures that directly relate to their clinical specialty and outcomes for their patients; and CMS should carefully monitor modifications to the cross-cutting measures list and ensure that at least one cross-cutting measure remains on this list for each category of MIPS eligible clinicians to allow them to remain compliant with the proposed requirements. Alternately, CMS could develop an option similar to the outcomes measures reporting requirement that would allow the MIPS eligible clinician to report a different type of measure, such as a high priority measure, if a cross-cutting measure does not apply.

Response: We thank the commenter for their feedback and will take these recommendations into consideration for future rulemaking. We would like to note that there are already a number of outcome and specialty-specific measure sets available for reporting. In addition, the cross-cutting measure requirement is not being finalized.

Comment: One commenter recommended that CMS develop a pilot program/test within the first MIPS implementation year that identifies a core measure set that allows direct comparison among MIPS eligible clinician performance where commonly applicable metrics allow for such a measure set for specific MIPS eligible clinician specialties. The commenter supported the general flexibility of quality reporting, but was concerned that the existing proposal may not foster true comparisons and performance could vary based on the measures select