Secretarial Review and Publication of the 2020 Annual Report to Congress and the Secretary Submitted by the Consensus-Based Entity Regarding Performance Measurement, 48154-48229 [2021-18485]

Download as PDF 48154 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices ANNUAL BURDEN ESTIMATES—Continued Number of responses per respondent (total over request period) Number of respondents (total over request period) Instrument Guide for Implementation Study for Referral Provider Administrators ....................................................................................... Guide for Implementation Study with PCWA FUP Management (Second) ................................................................................... Guide for Implementation Study for PHA FUP Management ..... Guide for Implementation Study Focus Groups with PHA Frontline Workers ............................................................................. Guide for Implementation Study for Parents (Second, Third) ..... Guide for Implementation Study Focus Groups with Frontline Workers .................................................................................... Guide for Implementation Study for PCWA FUP Management (Third) ....................................................................................... Guide for Implementation Study for Service Provider Management .......................................................................................... Housing Status Form ................................................................... Referral Form ............................................................................... Randomization Tool ..................................................................... Housing Assistance Questionnaire .............................................. Ongoing Services Questionnaire ................................................. Dashboard .................................................................................... Administrative Data List ............................................................... Mary B. Jones, ACF/OPRE Certifying Officer. 1.00 2.00 1 2 2 1 1 1.00 1.00 2.00 2.00 1 1 6 72 1 1 1.50 1.50 9.00 108 3 36 180 1 1.50 270 90 6 1 1.00 6.00 2 5 185 60 3 120 120 12 18 1 31 10 200 3 3 27 2 1.00 0.04 0.17 0.02 0.09 0.09 0.17 5.00 5.00 230 102 12 33 33 56 180 2 77 34 4 11 LaWanda Burwell, (410) 294–2056. BILLING CODE 4184–25–P I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES [CMS–3402–N] Secretarial Review and Publication of the 2020 Annual Report to Congress and the Secretary Submitted by the Consensus-Based Entity Regarding Performance Measurement Office of the Secretary, Health and Human Services, (HHS). ACTION: Notice. AGENCY: This notice acknowledges the Secretary of the Department of Health and Human Services (the Secretary) receipt and review of the National Quality Forum 2020 Annual Activities Report to Congress and the Secretary submitted by the consensus-based entity (CBE) under a contract with the Secretary as mandated by the Social Security Act (the Act). The Secretary has reviewed and determined that the National Quality Forum’s 2020 Annual Report satisfied all requirements mandated in statute, and is publishing the report in the Federal Register together with the Secretary’s comments lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 The United States Department of Health and Human Services (HHS) has long recognized that a high functioning health care system that provides higher quality care requires accurate, valid, and reliable measurement of quality and efficiency. The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110–275) added section 1890 of the Social Security Act (the Act), which requires the Secretary of HHS (the Secretary) to contract with a consensus based entity (CBE) to perform multiple duties to help improve performance measurement. Section 3014 of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111–148) expanded the duties of the CBE to help in the identification of gaps in available measures and to improve the selection of measures used in health care programs. The Secretary extends his appreciation to the CBE in their partnership for the fulfillment of these statutory requirements. In January 2009, a competitive contract was awarded by HHS to the National Quality Forum (NQF) to fulfill requirements of section 1890 of the Act. PO 00000 Frm 00041 Fmt 4703 Annual burden (in hours) 1 FOR FURTHER INFORMATION CONTACT: [FR Doc. 2021–18438 Filed 8–26–21; 8:45 am] Total burden (in hours) 2 on the report not later than 6 months after receiving the report in accordance with section 1890(b)(5)(B) of the Act. This notice fulfills the statutory requirements. Estimated Total Annual Burden Hours: 355. Authority: 42 U.S.C. 676. Average burden per response (in hours) Sfmt 4703 19 60 A second, multi-year contract was awarded again to NQF after an open competition in 2012. A third, multicontract was awarded again to NQF after an open competition in 2017. Section 1890(b) of the Act requires the following: Priority Setting Process: Formulation of a National Strategy and Priorities for Health Care Performance Measurement. The CBE must synthesize evidence and convene key stakeholders to make recommendations on an integrated national strategy and priorities for health care performance measurement in all applicable settings. In doing so, the CBE must give priority to measures that: (1) Address the health care provided to patients with prevalent, high-cost chronic diseases; (2) have the greatest potential for improving quality, efficiency, and patient-centered health care; and (3) may be implemented rapidly due to existing evidence, standards of care, or other reasons. In addition, the CBE must take into account measures that: (1) May assist consumers and patients in making informed health care decisions; (2) address health disparities across groups and areas; and (3) address the continuum of care furnished by multiple providers or practitioners across multiple settings. Endorsement of Measures: The CBE must provide for the endorsement of standardized health care performance measures. This process must consider whether measures are evidence-based, E:\FR\FM\27AUN1.SGM 27AUN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible to collect and report, responsive to variations in patient characteristics such as health status, language capabilities, race or ethnicity, and income level and are consistent across types of health care providers, including hospitals and physicians. Maintenance of CBE Endorsed Measures: The CBE is required to establish and implement a process to ensure that endorsed measures are updated (or retired if obsolete) as new evidence is developed. Convening Multi-Stakeholder Groups. The CBE must convene multistakeholder groups to provide input on: (1) The selection of certain categories of quality and efficiency measures, from among such measures that have been endorsed by the entity and from among such measures that have not been considered for endorsement by such entity but are used or proposed to be used by the Secretary for the collection or reporting of quality and efficiency measures; and (2) national priorities for improvement in population health and in the delivery of health care services for consideration under the national strategy. The CBE provides input on measures for use in certain specific Medicare programs, for use in programs that report performance information to the public, and for use in health care programs that are not included under the Act. The multi-stakeholder groups provide input on quality and efficiency measures for various federal health care quality reporting and quality improvement programs including those that address certain Medicare services provided through hospices, ambulatory surgical centers, hospital inpatient and outpatient facilities, physician offices, cancer hospitals, end stage renal disease (ESRD) facilities, inpatient rehabilitation facilities, long-term care hospitals, psychiatric hospitals, and home health care programs. Transmission of Multi-Stakeholder Input. Not later than February 1 of each year, the CBE must transmit to the Secretary the input of multi-stakeholder groups. Annual Report to Congress and the Secretary. Not later than March 1 of each year, the CBE is required to submit to the Congress and the Secretary an annual report. The report is to describe: • The implementation of quality and efficiency measurement initiatives and the coordination of such initiatives with quality and efficiency initiatives implemented by other payers; VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 • Recommendations on an integrated national strategy and priorities for health care performance measurement; • Performance of the CBE’s duties required under its contract with the Secretary; • Gaps in endorsed quality and efficiency measures, including measures that are within priority areas identified by the Secretary under the national strategy established under section 399HH of the Public Health Service Act (National Quality Strategy), and where quality and efficiency measures are unavailable or inadequate to identify or address such gaps; • Areas in which evidence is insufficient to support endorsement of quality and efficiency measures in priority areas identified by the Secretary under the National Quality Strategy, and where targeted research may address such gaps; and • The convening of multi-stakeholder groups to provide input on: (1) The selection of quality and efficiency measures from among such measures that have been endorsed by the CBE and such measures that have not been considered for endorsement by the CBE but are used or proposed to be used by the Secretary for the collection or reporting of quality and efficiency measures; and (2) national priorities for improvement in population health and the delivery of health care services for consideration under the National Quality Strategy. Section 50206(c)(1) of the Bipartisan Budget Act of 2018 (Pub. L. 115–123) amended section 1890(b)(5)(A) of the Act to require the CBE’s annual report to the Congress include the following: (1) An itemization of financial information for the previous fiscal year ending September 30th, including annual revenues of the entity, annual expenses of the entity, and a breakdown of the amount awarded per contracted task order and the specific projects funded in each task order assigned to the entity; and (2) any updates or modifications to internal policies and procedures of the entity as they relate to the duties of the CBE including specifically identifying any modifications to the disclosure of interests and conflicts of interests for committees, work groups, task forces, and advisory panels of the entity, and information on external stakeholder participation in the duties of the entity. The statutory requirements for the CBE to annually report to the Congress and the Secretary also specify that the Secretary must review and publish the CBE’s annual report in the Federal Register, together with any comments of PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 48155 the Secretary on the report, not later than 6 months after it has been received. This Federal Register notice complies with the statutory requirement for Secretarial review and publication of the CBE’s annual report. NQF submitted a report on its 2020 activities to the Congress and the Secretary on March 1, 2020. The Secretary’s Comments on this report are presented in section II. of this notice, and the National Quality Forum 2020 Activities Report to the Congress and the Secretary is provided, as submitted to HHS, in the addendum to this Federal Register notice in section III. II. Secretarial Comments on the National Quality Forum 2020 Activities: Report to Congress and the Secretary of the Department of Health and Human Services Once again, we thank the NQF and the many stakeholders who participate in NQF projects for helping to advance the science and utility of health care quality measurement. Access to care, quality, and health outcomes took on a new urgency in 2020 as the COVID–19 Public Health Emergency (PHE) emerged, surged, and persisted across the United States. As the COVID–19 PHE endured, The Centers for Medicare and Medicaid Services (CMS) coordinated with NQF to ensure that measure endorsement and maintenance reviews did not stand in the way of frontline clinicians’ life-saving efforts. Measure review meetings originally scheduled for spring and summer of 2020 were re-convened later in the year and all meetings became virtual. These changes aimed at freeing up the schedules of frontline clinicians on the Standing Committees so that they could prioritize for the COVID–19 PHE. The dedication of the NQF Standing Committees and agility of NQF’s staff played a crucial role in maintaining a strong portfolio of endorsed measures for use across varied providers, settings of care, and health conditions. NQF reports that in 2020, it updated its measure portfolio by reviewing 84 measures and endorsing 65. Endorsed measures address a wide range of health care topics relevant to HHS programs, including: person- and family-centered care; care coordination; palliative and end-of-life care; cardiovascular care; behavioral health; pulmonary/critical care; perinatal care; cancer treatment; patient safety; and cost and resource use. In addition to maintaining measures endorsement, NQF worked to remove measures from the portfolio for a variety of reasons (for example, measures no longer meeting endorsement criteria; E:\FR\FM\27AUN1.SGM 27AUN1 48156 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices harmonization between similar measures; replacement of outdated measures with improved measures; and lack of continued need for measures where providers consistently perform at the highest level). This continuous refinement of the measures portfolio through the measures maintenance process ensures that quality measures remain aligned with current field practices and health care goals. Measure set refinements also align with the HHS initiatives, such as the Meaningful Measures Framework at CMS. CMS is working to identify the highest priorities for quality measurement and improvement and promote patientcentered, outcome-based measures that are meaningful to patients and clinicians. Throughout 2020, NQF continued the important work of building consensus from stakeholders on strategies to leverage quality measurement to improve health outcomes. The COVID– 19 PHE has glaringly exposed and exacerbated pre-existing health care disparities.1 2 Social determinants of health (SDoH) are crucial factors in health outcomes, and significant health lotter on DSK11XQN23PROD with NOTICES1 1 Zelner, J., R. Trangucci, and R. Naraharisetti, et al (November 21, 2020). Racial Disparities in Coronavirus Disease 2019 (COVID–19) Mortality are Driven by Unequal Infection Risks. Clinical Infectious diseases, claa1723. https://doi.org/ 10.1093/cid/ciaa1723 2 Ortiz, N., and D. Flamini (May 1, 2020) Does COVID–19 discriminate? Experts Discuss Pandemic’s Effect on Minority Groups. (https:// www.nbcmiami.com/news/local/does-covid-19discriminate-experts-discuss-pandemics-effect-onminority-groups/2227096/, accessed 2/24/2021). VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 disparities persist. The COVID–19 PHE has further illustrated longstanding health inequities with higher rates of infection, hospitalizations, and mortality among black, Latino, and Indigenous and Native American persons relative to white persons. Equity is not a new challenge, but despite past efforts, disenfranchised groups continue to experience worse health outcomes. Providing the highest quality of care is only possible, if we deliver equitable care. CMS strives to understand and address repercussions of the COVID–19 PHE on disparities. CMS has continued to leverage its partnership with NQF, recognizing NQF’s unique role as a CBE and its experience developing multistakeholder consensus. In 2020, CMS funded a project that focuses on quality measures for assessing the impact of telehealth on rural health care system readiness and disaster-related health outcomes. Another new project focuses on best practices for functional and social risk adjustment, including potential data sources other than those currently used by developers. CMS also funded a new project on quality measures that could encourage collaboration between the health care and non-health care sectors, like social work, public safety, and criminal justice to combat polysubstance use among opioid users with behavioral health conditions. NQF also continued to carry out several CMS-funded projects awarded before 2020 for which health equity is PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 front and center (for example, the Maternal Morbidity and Mortality project and the Social Risk Trial to galvanize stakeholders’ efforts to reduce disparities by closing the performance gap. Facilitating health equity across settings and payers is just some of many areas in which NQF partners with HHS to enhance and protect the health and well-being of all Americans. Meaningful quality measurement is essential to the success of value-based purchasing, as evidenced in many of the targeted projects that NQF is being asked to undertake. HHS greatly appreciates the ability to bring many and diverse stakeholders to the table to unleash innovation for quality measurement as a key component to value-based transformation. We look forward to continued strong partnership with the NQF in this ongoing endeavor. III. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Dated: August 23, 2021. Xavier Becerra, Secretary, Department of Health and Human Services. BILLING CODE 4150–28–P E:\FR\FM\27AUN1.SGM 27AUN1 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48157 NATIO.NA.L QUA.LITYFORUM Orlving·measurablehealth irnPr!:l~ments ttijetn~t l=inaltleport. Thisreportwasfunded by the centersfor Medicare & Medlc:aidServicesunder.ci:intract numoerHHSM- VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.012</GPH> lotter on DSK11XQN23PROD with NOTICES1 so0-2011-000$0t TaskOrder.HHSM-500-TOOOl. 48158 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Contents r. Executive.Summary........................... ... ............................................. ., ............... 4 111. Recomrnendattons onthe National auaiitystrategyand P:r1or1t1es ...................................................1 lmpactofCOVl~1!tandNQF Response ............................................................................................7 IV. aualltY and Efficiency: Measurement1n1t1at1ves {Peiforrnance Measurernent) .............................. 11 Cross<uttfng·Projectstolmprove.theMeasurement Process ........................................................ 11 SCida/Rlsk Trlfif........................................................................... m ....................' " ............................. 12 CurrentStateofthe NQF.Measure PQr:tfollo, ................,...........................,....................,................... .13 Measote. Endorsement and Maintenance Actompllshrnents ...................................,...................... 16 V. Stakeholder Recommendations.on O.ualtty and Efficiency Measures and NatlonalPrlorTtles ........ 23 MeasureApplleatlons· Partnershlp:..,.............,u,mm·•m""""···········..····"..·"•~ ...............................J •••• 24 MAP 2Cl19-20:zo Pre-liuleMaklntfRe~mmendatlons:,•••••••,,..............................,.................,•• ,......... 24 MAP Rl.lralHealth.Workgr'bup ................................... 25. m ......................' " ........................................... MAP HospltalWOriqtroUp;.......................°'.......................,...............................................,....." ......... 28 C:0f't'.Q.ualltYMeasuti!$•Coilabotattve~P:rl\illte.al'ld•·eutiirc.Ailgi'lment~,•• ,•••~ ••••••.,.........,,,;;,,,;;;;;;,;..,••• 31 VI. Gaps•ln Endo·rsed Quaflty arid Efflelei'tc:yMeasures ...................."' ....................,............................. 32 Gapsldentlf!ed In 2020Completed Projects ....................................................................................32 Measure AppllcatlonsPartnershlp!ltlentlfytng and Fllllng Measure Gaps ......,...,.,.,..............,......... 32 v11. Gaps1n·Ev1dence. and TargetedReseal"i:hNeeds: ............................................................................. 33 Attribution-Critical Illness/Injury.,............................................................................................m .•••.,33 LeveraglngElectronlc i:tealtll Record (Eflll)0Sourced Measurestolrnpro"'tare: Communication arid.COol'dlhatlon: ............................................m ......." ' .......................... " .............. 34 Rural Flealth Perspective ............. ,•!•"•.•·· .. ·•m·• .. ••• ..·••m••"····•·...·•·····...·•· ..·•··•·•·····•·• ..····"•···· .. ·~·..•···••·.. ·····35 Comi'hon Fol'matsfor Patient Safety ................................................'""'"'................................... ".. 3& Miiternal Morbldltyand Morta!Ity ............................................................................m .................... 39 Measure Fetldback Loop................,,...,,.,...'"....,...........,.....,........,...............,,... ,............., ................. 40 VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.013</GPH> lotter on DSK11XQN23PROD with NOTICES1 Bulldrng ii Roadfl'lap Fro:m Patient-Reported Outcome Measures to Patlent~Reported Outcofl'le Pel'foi'rtlance Meastll'eS:....................................................................................................................42 48159 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Electronic, Health Record Data Quality., ................................................,..................,....................... 43 Reducing Diagnostic Error ................................................................................................................44 VIII. ConclUslon .........-. ...,.......................111..,.............. "' ..-.................,. ..................... <1.1o••· ............ ,, .............. IX- Refe~ntes ...... H'll>n••·~........... .,~··~•!'H·n~n ............. .,.~~ .......... , ....... !._•u••-:•u·••·.n•it•h~~,···' ................................•............:...."o.vi-.i•··~•nu• 48· 1r •• ,, ..............................---. . . . . . . . . . 45- Appendix A: 2021) ActiVities Performed under contract With HHS......................,................,.................... 53 Appendix B: Multlstakeholder Group {tosters: Committee; Workgroups; Task Forces, and Advfsory Panels .................................................................................................................................'" ...................... 57 Appendix C: Scientific Methods, Panel Roster............................................................................................. 62 Appendix D: MAP Measure Sefe'ction Criteria ............................................................................................,63 AppendlX E: MAP Structure, Members, Criteria for Service, and Rosters .................................................. 66 AppendlxJ:: Federal (luallty Reporting.and Performance-Based Payment Programs Considered by Appendix G: Identified Gaps 'by NQF Measure Portfolio .........................................................'"'" ............. 69 Appendix H: Medicare Measure Gaps Identified by NQF's Measure Appllcatlons Partnetshrp ................. 70 VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.014</GPH> lotter on DSK11XQN23PROD with NOTICES1 Appendrx I: Statutery Requirement of Annual Report Components .......................................................... 73 48160 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices I. Executive Summary The.National Quality Forum {NQF) Is a not-for-profit, non-partisan, membership-based organization that works tQgether with healthcare stakeholders as a catalyst to drive measurable health Improvements. A collaborative approach driven by sdence, these experts provide a balanced perspective to advancing quality measurement and Improvement strategies that help the nation achieve. better and affordable care, whfle lmprovlngthe overall health of Americans. The.Social Security Act'--'speclflcally section 1890(b){S)(A)~mandates that the entity {In this case, NQF) report to Congress and the secretary of the Department of Health and Human Services {HHS) highlights work performed hi 2020 under contract with HHS. This annual report summarizes the. followlng five areas: • • • • • Recommendations on the National O.uallty Strategy and Prlorltfes O.ualfty and Efficiency Measurement Initiatives {Performance Measures} Stakeholder Recommendations on Quality and Efficiency Measures and National Prlorltles Gaps In Endorsed Quality and Efficiency Measures Gaps in Evidence and Targeted Research Needs Recommendations on.the NatlonalQualtv Strategy and Priorities The NatlonatO.uallty Strategy (NQS}, first published In 2011, was established as a coordTnated approach for quality Improvement In healthcare. This strategy focused on three alms to Improve health and the qualltyofhealthcare targeting local, state, and national efforts. With NO.Sas a foundation, the Centers for Medicare & Medicaid Services (CMS}establlshed the Meaningful.Measuresframeworkthatldenttfles specific priorities addressing core topics that are critical to providing high quality care and Improving lndlvlclual outcomes, NQF and CMS continue to work together to ensure that NQ.F's work aligns with this framework to assess core Issues that are most.vital to high quality care and better patient outcomes. No.Fis committed to addressing national health priorities and collaborating with Important stakeholders to drive better outcomes. Thls year, the COVID-19 partdemTc has hlghlfghted both the strengths and weaknesses in America's healthcare delivery system. CMS and NQF recognized and worked to address some Immediate challenges that came to llghtdurfng the pandemlc. To.aid In this effort, NQF received funding for a series of projects thatwould hefp to tackle some of the challenges the healthcare community has f.-ced since the onset of this pandemic, Qualltyand Efficiency Measurement Initiatives. (Performance Measures) NQF Is committed to driving the use of best-in-class quality measures for use in federafand private Improvement programs (Including statutorily mandated Medicare programs, such as the Quality Payment Program, Hospital value-Based Purchasing (VBP) Program, and other reporting lnltfatlves across various care settings). Through a consensus-based approach, measures undergo carefu.l evaluation through a set of rlg0rous criteria to ensure that they address aspects of care that are Important and feaslble to measure, provide consTstent and credible Information, and can be usedfor quality improvement and decision making; This year, NQF endorsed 84 measureucrossa variety of clinical and cross-cutting topic areas. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.015</GPH> lotter on DSK11XQN23PROD with NOTICES1 Performance measures also rely on evldem:e-based reseatch and scfentlflcmethodologyto ensure highly rellable and valid outcomes that represent and. affect patient care. To that end, with funding from HHS, NQF undertook new work to provtde technical guidance to measure developers on complex Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48161 methodological issues. Best Practices fo.rDeveloping and Testing Risk Adjustment Models focused on the Importance .of expiating and appropriately adjusting or stratifying for soctal and.functional rlskfactors so that providers can be accurately. assessed and not Inappropriately penalrzed flnanclallyjust because their patient populations are.sicker or have special healthcare needs. NQF also continued its efforts With the Soda/ Risk mat byworldng with ftS Scientific Methods Panel (SMP) to revlew.socral. risk adjustment approaches for outcome measures submitted for endorsement or re-endorsement. The SMP and NQF's otsparttles Committee also .examined the technical Issues that remained inconcfUslve at the end of the Initial ttial to finalize recommehdatfonsfor the government on social risk adjustment. Stakehold« Recommendations onQuallty and Efflctency Measuresand National PrlOl'lttes Measure alignment across the public and private sector ls vftalto reducing burden for providers and clfnTclans and allows for qualfty comparisons across provtders and programs. NQF recommends the bestln-class quality measures for use In federal and private lmprovementprograms. This. effort for measure alignment continued during 2020•.Specific projects Include the Core Quallty Measures Collaborative {COMC) and the Measures Application Partnership (MAP). The to.Mc ls a merribershlpedrlven initiative wltb funding provided by C:1111S and America's Health Insurance Plans (AHIP). over 70 organizations are members ofthe CQMC, Including CMS, health Insurance providers, primary care and specialty societies, and consumer and employer groups. this group ls working to reduce measurement burden byfacllltatlng cross-payer: measure alignment through the developmentand adoptlort of core measure sets to assess the qualify of us healthcare. The Measure Applications Partnership (MAP), convened by NQF since its Inception ln 2011, provides guidance on the use.of performance measures in federal healthcare quality programs. These recommendations are made by MAP through Its pre-rulemaklng process, which enables a multlstakeholder dialogue, with beth the public artd private sectors, to assess measurement prforltles forthese programs. MAP reviews measures that CMS is considering for implementation and provides guidance on their acceptability and value to stakeholders. This. review focuses on the selection of high qualify measures that optimally address health system Improvement priorities,. fill critical measurement gaps, and increase alignment. Gaps In ·Endorsed Quallty andEffldency Measures Multlstakeholder committees continue to discuss and Identify gaps that exist In current measure portfollos and the lrnpact on qualify ofcare. In addltlon to Its role of recommending measures for potential inclusion· into federal programs, MAP also provides guidance on identified measurementgaps at the Individual federal program level. MAP specifically addressed the high-priority domains CMS Identified In each ofthe federal programs for future measure consideration. Gaps 111· Evidence and Targeted Resean:h Needs VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.016</GPH> lotter on DSK11XQN23PROD with NOTICES1 NQF's foundational frameworksfderttlfy and address measurement gaps In Important healthcare areas, underpin Mure efforts to Improve quality through metrics, and ensure safer, patient-centered, and cost-effective care that reflects current science artd evidence. In 2020, NQFUndertook StWeratprojetts to create strategic aj:,prQaches, or frameworks,. to measure qualll:y In areas crltlcalto Improving health and healthcare for the nation but for which quality measures are too few, underdeveloped, or nonexistent. Efforts included measurement frameworks for maternal motbidlfy and mortality, personcentered planning and practice, measure feedback loop, patient-reported outcomesJPROs), electronic health record {EtlR) data quality, common formats for patl1mt safety, and reducing diagnostic error, In 48162 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices addition, NQf Initiated work on five new strateglc measurement frameworks addressing attrlbutlon, rural health, oplolds and behavioral health, EHR-sourced measures for care coordination, a-nd patientreported outcome performance measures (PRO-PMs). Taken together,.NOF's quality work continues to be foundattonalto .efforts to achleve.a cost-efficient, high .quality, and vall.l&-basecfhealthcare system that ens1.1res the ~est care for Americans and the best 1.1se Ofthe natic>n's healthcare dolfars. The del!Verablell NQ.F•produced under contract wlth !iHS In 2020 are referenced throughoutthis report,and a full list is included in ~dix A, II. N0.F Fundfni and Operatle>'1$ In 2018, the Bipartisan Budget Act amended the requirements of this annual report to Include, In addition to the previous requirements set forth, new contract, financial, and operational information related to the Consensus-Based Entity (CBE), Section 1890{b)(S){A). ofthe Soeiaf Securlty Act ls amended by.adding thefo/lowlngjlnanc/al and operations Information In the Annual Report to Congress and the Sectetary• an Itemization off{nancfalln/ormatfon for the fiscal year entllng September30of the preceding year, including: o Annual revenues of the entity (Including any govemmentfundlng, private sector contributions, grants, membership revenues, and Investment revenue) o Annualexpenses of the entity {including grrints paid, benefits paid, salaries and other compensation, fur,dralslng expenses, and overhead cOSts}; and o a breakdown ofthe amount awarded per contracted task order.and the spedf{cprojects funded In eaclrtask order assigned to the entity · • Any updates or modifications oflntemalpolicfes and procedures ofthe entity as they relate to the duties ofthe entity under this section.including (i)speciflcally identi{ying any modifications to the disclosure of lnteresn:md confllcts.offmerestsfor committees, work groups, taskforces, and advisory panels of the entlty;.and (fl}lnformatlon on extemal stakeholder participation In the duties of the entity under this sectlon.{lncfudlng complete rosters/or all committees, work groups, task fr,rr:es, andlJdVlsorypanets funded through government contracts, descriptions of relevant Interests and any confflctsoflnterests for members of all committees, work groups, task fortes and advisory panels, and total percentaOR by healthcare sector ofal/convened committees,. work groups, task forces, and advlsorypanels. NQF~s revenues for FY 2020 were $21,881,093 million, Including federal f1.1nds authorized under SSA 1890(d), prlVate-sector contributions; membership revenue, and Investment revenue. NQF's expenses for FY 2020 were $19,286,448 million. These expenses Include grants and benefits paid, salaries and other compensations, fundralslng expenses; and overhead costs, VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.017</GPH> lotter on DSK11XQN23PROD with NOTICES1 A complete breakdown of the amount awarded pera,ntractts available In Appendix A. Addftlonally, NQF contlnUE!ll to Institute !'ts conflict oflnterest process;.AII multlstakeholder groups (committee, workgroups, task fotce, and advisory panels) must .disclose any potential bias or conflicts. ofinterest prior to befng appointed. ln.2020, NQF has made no 1.1pdates or modfflcatlons to its dlsclQSure of Interest andconfllct oflnter;es,; pollcies. Rosters ofcommltteesand workgroupsfunded under the CBE contract are available tn Appendix B, Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Ill. 48163 Recommendations on the National Quality Strategy and Priorities Section 1890(b){1) of the Social Security Act (the Act) mandates that the CBE shall synthesize evidence and convene key stakeholders to make recommendations •.. on an integrated national strategy and priorities for health care performance measurement In all applicable settings. In making such recommendations, the CBE shall ensure that priority Is given to measures: {I) that address the health care provided to patients with prevalent, high-cost chronic diseases; (ii) with the greatest potential for Improving the quality, efficiency, and patlent-centeredness of health care; and (Ill) that may be Implemented rapidly due to existing evidence, standards of care, or other reasons. In addition, the CBE Is to "take Into account measures that: (i) may assist consumers and patients In making Informed health care decisions; (ii) address health disparities across groups and areas; and (iii) address the continuum of care a patient receives, including services furnished by multiple health care providers or practitioners and across multiple settings. n The CBE ls required to describe this activity In this report pursuant to section 1890(b}(S)(A)(l)(II) of the Act. The NQS, first published In 2011, was established as a coordinated approach for quality Improvement In healthcare. This strategy outlined three alms used to guide and assess local, state, and national efforts to Improve health and the quality of healthcare; six priorities focused on reducing harm, engaging famllies, Improving coordination of care, and making quality care more affordable. Using NQS as a foundation, CMS established a Meaningful Measures Initiative, which identifies specific priorities addressing core topics that are crltlcal to providing high quallty care and improving Individual outcomes. NQF aligned work and efforts In 2020 with the CMS Meaningful Measures framework, speclflcally the meaningful measure areas of equity of care, prevention and treatment of opioid and substance use disorder, patient's experience of care, and transfer of health Information and lnteroperablllty. Several NQF projects focused on targeting these areas and are referenced through four major themes-COVID• 19 and NQF Response, Patient-Directed Outcomes, Digital Measurement, and Aligning Quality Measurement. Impact of COVID-19 and NQF Response NQF gathered data, through several multlstakeholder discussions, on the Impact of the COVID-19 pandemic as It relates to quality measurement and reporting. These findings hlghllghted the Immediate challenges facing active NQF endorsement and maintenance activities. Committee members responding to the COVID-19 pandemic (e.g., front-line cllniclans) were faced with competing priorities, which limited their ability to actively participate on committees. NQF member organizations began focusing their resources to target the negative impact of the pandemic, while measure developers faced challenging timelfnes with limited staff time and access to testing sites. To address these challenges while balancing multlple stakeholders' needs and continuing this important work, NQF proVlded greater flexibility for stakeholders active In the endorsement process. This included extending public commenting periods and creating two timeline tracks for submitting measures to promote optimal particlpatron. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.018</GPH> lotter on DSK11XQN23PROD with NOTICES1 Addltlonally, NQF issued a statement encouraging end-users to work closely with measure developers to think through optimal temporary adjustment strategies in order to preserve validity, reliability, and risk adjustment appropriateness. To that end, NQF will not review any temporary changes to measure specifications In 2020 and Is committed to providing more guidance, If needed, as the situation evolves. 48164 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Lastly, in 2020, NQF received funding for a series of projects that would help to tackle some of the challenges the healthcare community has faced since the onset of this pandemic. Best Practices tor Developing and Testing Risk Adjustment Models COVID-19 has disproportionally affected racial/ethnic minority groups and exacerbated existing disparities confronting the medically underserved. Compared to Medicare-only beneficiaries (Centers for Medicare & Medicaid Services, 2020), dual-eligibles have a considerably higher number of hospltalizatlons across racial, ethnic, and gender categories during the COVID-19 pandemic thus far. This demonstrates that race, gender, and clinical factors may not fully explain the difference In health outcomes. The First Report from the Assistant Secretary for Planning and Evaluation (ASPE) to Congress found that functional status is also an important Indicator of poor outcomes but is not always included in measure risk adjustment (US Department of Health & Human Services, 2020). Thls further underscores the Importance of exploring and appropriately adjusting or stratifying for all applicable social and functional risk factors so that providers can be accurately assessed and not Inappropriately penallzed financially just because their patient populations are sicker or have special healthcare needs. COVID-19 has also revealed opportunities to Improve access to care for those socially disadvantaged. Assessing risk factor Interactions, such as access to coronavlrus testing and socioeconomic status, are Important considerations In the development of a standard social risk adjustment process. This newly funded project will review current best practices for developing and testing risk adjustment models for quality measurement. Addressing Opioid-Related Outcomes Among Individuals With Co-occurring Behavioral Health Conditions The ongoing opioid epidemic has been compounded by COVID-19 with research Indicating increases in opioid-associated morbidity and mortality (WIiiiams, 2020). People who have been battllng addiction have found themselves increasingly isolated and with fewer distractions from dependency behaviors due to COVID-19 social restrictions, placing them at increased risk for recovery setbacks (Blum Alexander B. et al., 2014; Franks & Fiscella, 2002), COVID-19 has also resulted in decreased access to treatment for opioid and other substance dependencies. With increasing use of telemedlclne, cllnlclans are challenged to ensure appropriate drug screening is conducted during routine appointments (Sliva & Kelly,2020) This newly funded project will develop an environmental scan to assess the current state of opioidrelated healthcare quality measurement. NQF will also convene a Committee to help Identify gaps and provide recommendations on the Inclusion of measures In various federal programs and future measure development efforts regarding challenges posed by opioid use In the United States (US). Attributionfor Critical Illness and Injury VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.019</GPH> lotter on DSK11XQN23PROD with NOTICES1 The COVID-19 pandemic has presented situations In which opportunities for time-sensitive care are often based on geography rather than health system network affiliation. Localized emergencies and nationwide threats to public health require population-level responses, Including timely diagnosis, tracking, Interventions, and coordination to achieve the best outcomes for all patients. A new approach in measurement attribution Is needed for quality measurement to reflect the reality and challenges of Improving health outcomes during emergencies. Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48165 The ongoing pandemic has und.erscored the challenges ofmaklngaccurate attribution of the patient's coronavlrus Infection-related health outcomes to providers. An TndMduatwho seekscoronavlrus testing or treatm!:!nt maY recelvei;ar!:! from a $tand-alcme urgent care center; a neighborhood pharmacy, first responders; emergency.department (ED) tlfrilc!ans.orlhtenslvecare unltS't>f morethanone hQSpttal,and multiple nurses and specialists. Whete patients can receive care Is contingent orr fattorssucliatthe ED's othospTtal's surge tal)aclty, avallabllltyofventllators,. a··pauer1t's meansof ttarisportatlon to.testing sites, andavallabillty of coronavlrustests In the patient's communltyorstateofresldence. Providers lnvolvEld In a pattenfs ca.re !l'la.Y llO~.pelqng.to the .sa!l'le n!:lt\Vorl< and may ne>t be ablatocommunti;ate with each othafusln, lnteroP!:!r:able eHRs aix>11t the tndMd~rshea1thcate nee~.~ a resui~prlmarv care pl'(iViders, who usually assume the role of care cootdlnator, mayor may not be aware.ohh!:!lr patients' eoronalilrus-related ED vtslts:or 1n1>at1ent stay!!. These factors represent Important e)atmples of why.pographlc or pc,pulat!on-based measure a.ttrlbut!on models are needed to supportteam•based, cootdlnated emergency responses; NQFwlll col)vene amultlstakeholdertornmttteeto make rt1cornm!:!ndatlqn~ fordE!Velor>ln, geographicalfpopulatlon-based attt1b1.1t1on1T1odeisapplltabti! to the quality measurement of hlgh-'iltUltv emergencycareS!:!nsrtrve conditlomtlECSCslresultlngfront masscasualtvlncidents;.suehasthe: C:QVJD19 pandemfc, trauma resultlngfrom mass shooting or bombln& natural dlsasters(e,g., hurricanes; wildfires, and earthq~kes), and otherpubnc health emersencres. Patlent-btrectedOUtcon'll$ PatrentandfarriHyengagementarelncreastngly.acknowledpd as key components of a comprehensive strategy, along Wlth performan:celmprQvementandaccountabllltv to achieve a· high quality; affordable healthsystem, Eml!f'$llllJEMdel'lce affirms that patients who are engaged In thelrcare:tend to experience better outcomes. and choose less costly but effective Interventions, such asphyslcaltherapy for low back pain, after partlcfpatlngln a proce~ofshared deelslon:maklng, NO,: cont.inuasto strategtcallyfocus ()fl includlng.the:patlenfperspectlvewlthln theC:Onsensus Development Pli>CeS$ (CDP) and during the revl!:!W ahd evaluation of measures, 1naddit1on: to expanding upon measurement for PROs. High lighted below are twoCMS~funded projetts thatemphaslze efforts to address patient outcomes; Patient arnl:Caregfile:rEngagement (P.ACE}Advlso,yGroup VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.020</GPH> lotter on DSK11XQN23PROD with NOTICES1 NQF values the patlentand caregiver volcaln the endorsement proces5;whlch resulted ln the:convenlng of the Patlent.andCareglver Engagement(PACE) Advisory Gl'Qupto prollfde guidance.on NQF's rnrtratlves to enhance.patient and tareglvetengagementon NQF stand1na.comm1ttees, such as providing assistance v.tlth recruiting patients/caregivers during the CDP nqmlnatlons cvcle, developfnga patlent[careglvercriP ortentatlon sessft>n,and deve1t>1>1hga pilot mentotshlp program to support n!:!W patients/caregivers on CDP Standing committees. The PACEAc:Msorv GroUf),. composectof t!i patient and caregiver representatives, Pl'Ql'!dEldll)pUton strate~for rei;rultlng patlents.;md c:areglvers, redutlngbarr1erstopat1entandcareglverpartlelpatton, and preparing patients and caregivetsto participate suctesstU11y1n committee dlscuufons. To. sur>port new patients. and careglvert on committees, NQFlnstltute.d ii mente>rshlp program for n!:!W patlents ancl i;aresivers thJtwas 1mprttmented torthe fall 2020 endorsement measure evaluation cycle; NQF also worked wrttfStand1ng committee co-chairs to actively engage patients and caregivers In meetings to provide their perspecttve, enhancing committee delfberatJonsand suppc,rtlngstakE!holder diversity. 48166 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Patient-Reported Qutc:omes (PROS): Best Practices Off Selection qnd Datq Collection Thfs CMS funded project addressed the barriers faced fn the adoption of patlent•reported outcomes (PROs) and patient-reported outcome perfprmance measures (PRO-PMs}~ The project reviewed five commonly used PRO categories, then presented four best praetlcesJorPRO selection in clinical care. ldentlfled In the report are ways to engage patrents lnamultlstakeholder selectfon process as the voice of patients; faml!Y h'!l!mbers, and caregNers 1~ critical to the PRO selection process. Also outlfnecun the report ls guidance to cllnfcfaris and organizations that 1:an be used In addressing barriers In care management and planning, barriers that affect the;selectlon and Implementation of PROS and PRO-PMs. The final report re\ilewS commonly used PRO categol'.leS and discusses ~st practices fur PRO. selection. Building a lfoadmap From Patient-Reported OutcomeMeasures to Pattent-Repotted:OutcomePerfortnance Measures Commencing in late 2020, the project wm convene a multlstakeholdi?r Te1:hnlcal Expert Panel {TEP) to help Identify attributes of high quality patient-reported outcome measures {PROMs) and to provfde guidance to measure developers on how to develop digital PRO-PMs based on those PROMsthrough a step-by-step roadmap. The TEPwlll Include patli?nt representatives who have 11\ied experience with chronic pain and functional llmltatlons, two condition areas that have a slgnlfrcant number of exlsttng; vaffdated PROMs. EHR-Sourced Measures NQF has Identified the ablllty of EHR systems to connect and exchange data asan fmportant aspect of quality. healthcare. However, electronle cllnleal quaUty measures (eCQMs) and EHi\ data are not enough to enable automated quality measurement. Currently, NQF has endorsed nearly 540 healthcare performance measures with only 34 of these being eCQ.Ms. Although the number of endorsed eCQMs Is low, several. measures In Na.F's portfolio are quality measures that rely on data that come from an EHR, which NQF refers to as EHR-sourced measures. As evolving te1:hnologies emerge, there will bea greater need to promote the transformation of these EHR-sourced measures to dlgital. health and.support the adoption of digital quality mesure'!i, c,r dO.Ms. However, to better understand the potential of Improving quality measurement with the use of EHR data for cflnlcaf quality measures, or co.Ms,. !tis rmportantto examine the current state of EHR data quality, To that.end, CMS funded a new Initiative that focuses on the need to coordinate care using EHRsourced quality measurement. Leveraging Electronic Health Record (EHR)-SOurced Measures to Improve tol'f! Commullklatic»'I and Coordlnat/on VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.021</GPH> lotter on DSK11XQN23PROD with NOTICES1 Measuring care Comrnunlcatlon and coordination has been challenging because of the.array of approaches and interventlons;:.difficulties in measuring.specific activities.and in generalizing program success; and linking approaches to Improved outcomes.This need for increased care communlcatloli and coordination has been underscored by the challenges of soda I distancing a'nd the number of patients seeklngtelehealthservices due to COVID-19. care coordination isan effective tool to streamline ctimmuntcatlon bet\Veen each ellnlcian, patient.and caregiver throughout the.continuum of care. ln coordinated care, healthcare teams should stnve to understand and tmplement.a cohesive care Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48167 plan In which goals do not change as the patient moves from setting to setting (WIiiiams, 2020) so that they do not experience duplicative testing and treatments that increase patient risks. EHRs are primarily designed to support patient care and billing, but they also contain tools and specific design features that aid In capturing data for secondary uses, such as care coordination. EHRs have the potential to improve care coordination and how It Is measured during the challenges of a pandemic. In 2020, NQF continued the implementation of an 18-month project {initiated in 2019) to identify the causes, nature, and extent of EHR data quality issues, particularly as they relate to measure development, endorsement, and Implementation. This newly funded project will Identify best practices to leverage EHR-sourced measures to improve care communication and coordination quality measurement In an all-payer, cross-setting; and fully electronic manner. IV. Quality and Efficiency Measurement Initiatives (Performance Measurement) Section 1890(b){2) and (3) of the Act requires the consensus-based entity (CBE) to endorse standardized healthcare performance measures. The endorsement process must consider whether measures are evidence-based; reliable; valid; verifiable; relevant to enhanced health outcomes; actionable at the caregiver level; feasible for collecting and reporting, responsive to variations /fl patient characteristics,. such as health status; language capabll/tles, race or ethnicity, and Income level; and consistent across types of healthcare providers, including hospitals and physicians. In.addition, the CBE must establish and Implement a process to ensure that measures endorsed are updated {or retired If obsolete) as new evidence Is developed. The CBE Is required to describe these duties In this report pursuant to section 1890{b}(S}{A)(l}{III) of the Act. cro.cutting Projects to Improve the Measurement Process Performance measures rely on evidence-based research and scientific methodology to ensure highly reliable and valid outcomes that represent and influence patient tare. To that end, With funding from HHS, NQF undertook new work to expand the science of quality measurement. Risk Adjustment The quality measurement enterprise seeks to llnk payment to quality of care, generally known as valuebased purchasing (VBP). For VBP to be successful, patients need accurate and reliable information on provider performance to make Informed decisions. In addition, providers need comprehensive, rellable, and timely Information to make quality care decisions that result In Improved outcomes for patients while being held accountable for those outcomes in afair and comparable manner. To level the playing fleld, risk adjustment methods have been applled to many measures, but not all, and not. In a standardized method across measures. As part of NQF's COVID-19 response, assessing risk factors continues to be of high Importance when considering social risk adjustment. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.022</GPH> lotter on DSK11XQN23PROD with NOTICES1 Risk-adjusting measures to account for differences In patient health status and cllnlcal factors (e.g., comorbldltles, severity of illness) that are present at the start of care have been widely accepted and implemented (Blum Alexander B. et al., 2014; Franks & Fiscella, 2002). However, the increased use of outcome and resource use measures In payment models and public reporting programs has raised concerns regarding the adequacy and fairness of the risk adjustment methodologies used In these measures, especially as it relates to functional status and social risk factors, such as income, education, social support, neighborhood deprivation, and rurality (Bernheim et al., 2016; Chatterjee & We mer, 48168 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 2019). Functional risk factors are lmportantto examine since they may mediate the relationship between social risk, quality outcomes, and resource use. Measure developers have long expressed a need for technical guidance on developing and testing social and/or cllnlcal risk adjustment models for endorsement and maintenance and the appropriateness of a standardized risk adjustment framework (National Quality Forum, 2017). Moreover, risk adjustment of functional status-related factors within quallty measurement Is under-explored and underutlllzed for comparing provider performance between health outcomes and resource use. For this effort, NQF will build upon several years of work on developing guidance for risk adjustment model development, including NQf's Disparities Prolel;t and the Social Risk Trial. In late 2020, NQF assembled.a TEP to work toward consensus decisions that yielded a scholarly environmental scan report regarding the current state of data sources used for risk adjustment, functional or social risk factors avallable for testing, and approaches to conceptual and statlstlcal methods for risk adjustment. In 2021, the TEP will use the results of the scan to develop technical guidance for measure developers that Includes emerging good and best practices on when and how to adjust for functional and social risk factors In measure development, Social Risk Trial In 2014, NQF published a !'.!m.!2!l recommending that performance measures should account for factors outslde the provider's control, such as a patient's age, gender, comorbld conditions, and other social determinants of health. Often; healthcare outcomes are not solely the results of the quality of care received but can be Influenced by social risk factors. Beginning In 2015, NQF Implemented the first Social Risk Trial, a two-year effort between 2015 and 2017. During this period, NQF relaxed the policy against social risk adjustment In reviewing outcome measures submitted for endorsement or reendorsement. Soon after the trial, NQF released a final report In August 2017, reaffirming the recommendation In their 2014 report that performance measures should be risk-adjusted for social risk factors when conceptual reasons and empirical evidence demonstrate It Is appropriate • Also, stakeholders called for continuous efforts to examine some of the technical Issues that remained lnconclusfve at the end of the first trial. In response to stakeholders' concerns, HHS has funded NQf to. implement the second Social Risk Trial, a three-year effort that began In May 2018 and will conclude in May 2021. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.023</GPH> lotter on DSK11XQN23PROD with NOTICES1 As part of this funded work, NQf has continued working with the Disparities Standing Committee and the work of the Social Risk Trial, building upon the lessons of the Initial NQF•funded lnltiatlve. In 2020, the Disparities Committee met during two virtual meetings to review the risk-adjusted measures for the spring 2020 cycle submissions, review the risk models in use, and Interpret results. The graphic below (Figure 1) provides a breakdown of the total measures reviewed, including the number of outcome measures, those measures with a conceptual rationale for Inclusion of social risk, and a final number of measures that used some form of risk adjustment. 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Apncy·torflnfthcare·lesnrc:hartd.Qualtty· !:'!~-:::a::::n:::::!:..~:t~::dJ::,:::a:;::,~:•,:pattof SE:SadJustrnent, potentfal:to·tnask poor pert'Ormance and.cllsparitf-sihtare,artdnilat~:cOMtant dlstrlbutfon of·patients wrtfrrfsk :t'attors. · · Slttce2017/there . hav&bffrt'317··n,easuressubmttted';12softfiose·useci·$0m1t:fomi•aft1siM1dJUstli'lent .and120·measureshadac0rtteptu1l·modeioutl1n11'1ftti'elli'lp1ct·of·soctal·rtslc.Mostoftheli'leasUres subli'llttedwere•process li'lea.sures(45JJerterrt), andthtover1l1•·portfoUoofmeasures lrtcludedotli'et :l'l'l1t~rtt:ypliSr,S!;fd:i:~•.~~-ri1--~••fllt:l•:il'I~,lnt~~ia~-~~•i-~r:t.,r,11t,fl~~ .11iSO(ltceusit,,,l~tlst™ctilt'.eiri1~te~ 'lb~Dlij)jiitle~Standlril:'Cotilmltt~·•~tJepn•;~lditritHyd.-r~comtj:i~datlonsJc>ii:iskaidJ~iri~ of' ~liilfactotsfor'qi.i~Dfyri1e~~"i'it;The·t1~al:.tiipottfor'thls.p"'J.l~ct·winexptotethe:·1n,pa,ct.Qf'~la[. •rlikf¥1:~'"1th'•fresul_ts·.o1111easut1es.andtheJippropr1aten~of·1nc1udlril~1ar,ifsk(a;cton1othe:risk• iidJi.istmttrit modets;i,f'me~~bmf#i!d-tor,~~rit~~. rf th~f$iitoricept11ar~as1s·and e11iptrfcatev1dertij1\t0:~ppoit•th>ina·JP.-1n·ac1c11~~thls:rjpQtt.•1s·e,cpegld·t_oa:~aiite•thes¢1en~.•Qfi:fsk .•dJ~eritand-pn>111"9expert·au@~rice'tcfaddreSiithe'ctia11,~s\aiid'oppoitunlt1t~f'i!l1ted:t~ _lr,lclµdlnis«idaltlsff,-i:;t~fr(risk'adjusi:_ri1e(it1Ti!>~~'.1'h•flijaltjportfQ'tt~ls:•ptoJijcf.""ll·b•tornplt~d, lnlµly2~; ·Qlffl!l'ltStateoftheiNQFMeasu~ Palffallo NQF encourapimeasure•developersto·.ubrtiitmil!a.suniS•that tan··ttriwmeaniriilUlin1pivvernentsirt .·•careand·ftt.knowrrmeasure·ppsthat.affcnwtthhealthe1re·•finprovement·prforltles.-NQF·br1np .•::mu:::===~~=~~=a:d~~:.:h=Th~::=::.::=:rt:: ·meuurediweloperstoretelve·atlmelvrevfewof·thttr•meau~ln:addftlorrto•redud!i.1-Cornli'lhte• •di>wntlme•betweer1·rev1ewcvdes.· VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.024</GPH> lotter on DSK11XQN23PROD with NOTICES1 . .NQPs.endprsecl. measure·porffoliouncter,oe,·.an•evaluatf'on•formliiintenance•of eniiorsemenf :approxin1attilyeverythree,years.Th• maintenance process ensur8$that_lllClfaendorsed ·melSUl'e$• -representcurrentcliriicalevidence, contlnu•,tohav-ameaningful.•!JPpoti:uriity to Improve. and have .·.beenimplementedwithoutnepiive/uriirrte:nded ~quenceLln•amalritenancereview,N'QF 48170 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices COrnm~• rlW!~wptlW!c;usty eJll:I~ J!1'8il$Ur&S to. cfetermlrlelf thitYstlll meetNQf trlterlllf!:)r en.4~~•nt. Thiltllal11t•n•~~·l'l!Vle\v·m•vmu.1t•111~1111•Jhd~•~Jorm~res*hat·nc; lqrpr~t•~~;ifi!c:lll1:iltlngmeasurith!ltml)flllatfAAarnbi1&.tj>rnp.lng··or$1l'llllar··rn.,.~~ orrettt1'1irneasQ~th~rioion,er.p~a•l!l(ri1t1c~topporti.ln~•sfol'irti~ment•.· Ttitsyear, NQFtellil!!Wlid Mmeasu~ bmhnMi1111d mahitenance measui'I!!$, atlv$$ilivarietyof tHrlital andtto55-tuttll'l(toplcar&astsee~r&2)•.. Flp,-i,.NumbarofMusu•·Rfllllwect•lii.the: FIIH.20:1$:and•SP,rincmo~ .Pali .ao• M~re cyit•· Tt New M~$UT!/t$ ~OaHQ M.easlU'eC)'d• - 14Ne~M~ur• 2S Mattt~!'lanee ~asuies The data·. hflhl"1ttil decllri& li'i.$Ubmffte(I m ~ ~rnparl!Cf tO'previous.yttrs(ll'12Q~.,,thJ1:1!wt1jj• 1p~µ~1ttectm~resfctu•1n part·tQ•t1tc:umstane•$Utto,md111g•ttiecc;QY1~dof:!al pandemtt\ H(JYl~•.·•ttie:measQteme11t··c:ommuri1ty c:o11,1nuestc,•\IOl~thetmplJrta~•C)fthfand~ent process. ·A,nong·those$llbrnl~S8JJ~ehf.W~~C)lllt.·rneasu~{~lgUre 3}.>.ddltfonally,··NWcltciseea, sfl&ilt•u~~lneCQM.s,.ri!c:•vlril~m11uurasdortngthi~{~8$•(1n;lQ:!.!J,·thi!l:1!werit1J11lyflve)• .Flpre S,Measurel'ypesllevli!Wed·our111JtM Fal20191ftd...11J20H·ijdei ....,..~s: 21',W4 bl.rteome. w" Q\itci)~;PRO-l>M .7,141' C<i$l: VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.025</GPH> lotter on DSK11XQN23PROD with NOTICES1 <1.1a~ ~rnpqi.1t~ J.11~ Effitj&n~y . 2,31m ciutco• tn~eclla~ dt~1a11 VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 48171 EN27AU21.026</GPH> lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48172 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices NQF's multlstakeholder Committees, composed of stakeholders from across the healthcare landscape (e.g., consumers, providers, patients, payers, and other experts), review both previously endorsed and new measures submitted using NQ,F's measure evaluation criteria. All measures submitted for NO.F endorsement are evaluated agalnst the following criteria: • • • • • Importance to Measure and Report Rellablllty and Valldlty-Sclentlfic Acceptablllty of Measure Properties Feaslblllty Usability and Use Comparison to Related or Competing Measures Measure Endorsement and Maintenance Accomplishments NQF's measure portfollo Includes measures from 14 cllnlcal and cross-cutting topic areas. The following paragraph hlghllghts Its Importance and the outputs from the endorsement process during the spring and fall cycles. All-Cause Admissions and Readmissions Unplanned returns to the hospital, Including visits to the ED, are costly, common, and potentially avoldable (Auerbach et al., 2016; Collins et al., 2014). Studies have shown that patients discharged from the hospital have an Increased risk for being readmitted, and approxlmately a third of these readmissions are preventable (van Walraven et al., 2011). The Agency for Healthcare Research and Quallty (AHRQ) found that roughly 3.3 million US readmissions In 2011 occurred within 30 days of discharge and contributed to a total cost of $41,3 bllllon across all payers (Hines et al., 2014). Furthermore, studies have shown that patients discharged from an Inpatient hospltallzatlon are at an Increased risk of an ED encounter (Hastings et al., 2008). From 2006-2016, the annual number of ED visits In the US Increased by nearly 25 percent, representing an opportunity to Improve care transitions that avoid an unnecessary escalation of a patient's condition (Ru! et al., 2016). The review and evaluation of admissions and readmissions measures continue to be a priority, speclflcally the endorsement of hospltal-wlde and condition-specific measures (e.g., renal, cardlovascular, and surgery) for various care settings, Including hospitals, home health, skilled nursing faclfltles, long-term care facllltles, Inpatient rehab facilities, Inpatient psychiatric faclllties, and hospital outpatient/ambulatory surgery centers. Currently, there are 34 NO.F-endorsed measures in the All-Cause Admissions and Readmissions portfollo, many of which are part of several federal quallty Improvement programs. The All-Cause Admissions and Readmissions Standing Committee evaluated one new measure against NQF's measure evaluation criteria during the fall 2019 cycle. This measure was lnltlally submitted for review during the spring 2019 cycle. However, due to concerns with Committee quorum and a lack of clarity on measure testing Information presented during the spring 2019 post-comment call, this measure was deferred to the fall 2019 cycle. The measure was ultimately endorsed. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.027</GPH> lotter on DSK11XQN23PROD with NOTICES1 In the spring 2020 cycle, the Standing committee evaluated two newly submitted measures and three measures undergoing maintenance review against NQF's measure evaluation criteria. Four measures were endorsed while one measure did not meet the criteria for endorsement. This was due to concerns around valldlty and the adequacy of the correlations of the measure score to other renal-focused quality measures. Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48173 Nine measures, seven maintenance and two new, were reviewed during the fall 2020 cycle. The final endorsement decisions will be finalized in 2021. Behavioral Health. and Substance use Behavioral health Is composed of not only mental health, but also substance use disorders (SUDs) and represents a key construct of healthcare across the globe, unified by brain-based etiology and behavioral symptomology. A comprehensive annual report of behavioral health prevalence data is found In the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Survey on Drug Use and Health (NSDUH). Results from the 2018 NSDUH Indicated that 19.3 million Americans age 18 years or older suffered from an apparent SUD (not including tobacco dependence), and 47.6 million Americans age 18 years or older suffered from a mental Illness. This rate Is consistent with other epldemlologlc studies that have previously revealed the prevalence of behavioral health conditions !rt the US (Kamal, 2017). The 2018 NSDUH further discusses an important concern about US behavioral healthcare: Only 10.2 percent of persons age 12 years and older with SUDS reported receiving treatment during that year and only 43,3 percent of persons age 18 years and older with any mental Illness reported receMng care for that condition (Bose.et al., 2017). These gaps In behavioral health pathology and treatment represent unmet needs among those with behavioral health conditions. The review and evaluation of behavioral health measures have long been a priority of NQF with endorsement for mental health and SUD measures going back more than a decade. At present, there are 42 NQF-endorsed behavioral health measures. During the fall 2019 cyde, the Behavioral Health and Substance Use (BHSU) Committee evaluated seven measures for endorsement. The cycle Included the evaluation of measures, lhtludlhg the use of physical restraint and secfuslon, follow-up after ED visits for two newly submitted measures, and five measures undergoing maintenance review against NO.F's standard evaluation criteria. Five measures were endorsed while one measure did not meet the criteria for endorsement. This was due to evidence concerns. Addltlonally, one measure was withdrawn from consideration by the measure developer; During the spring 2020 cycle. the BHSU Committee evaluated one newly submitted measure and two measures that underwent maintenance review against NQF's evaluation criteria. One measure received endorsement while the other two measures did not meet the criteria due to Insufficient evidence supporting one measure and validity concerns associated with exclusion criteria for the other. Four measures, two maintenance and two new, were reviewed during the fall 2020 cycle. The final endorsement decisions will be finalized in 2021. Cancer Cancer Is the second most common cause of death In the US, exceeded only by heart disease (Howlader et al., 2020), The National Cancer Institute {NCI) estimates that in 2020, 1.8 million new cases of cancer would be diagnosed In the US and over 600,000 people will die from the disease (Marlotto et al., 2011). Furthermore, nearly 40 percent of all men and women In the us wlll develop cancer during their lifetime (American Cancer Society, 2020). In addition, diagnosis and treatment of cancer has great economic Impact on patients, their famllles, and the US healthcare system. For 2020, NCI estimates that the Costs for cancer care totaled could reach $174 bJlllon (Marlotto et al,, 2011), VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.028</GPH> lotter on DSK11XQN23PROD with NOTICES1 The cancer portfolio contains 18 NQF-endorsed measures that span various types of cancers (e.g., breast cancer, colon cancer, and prostate cancer). The Cancer portfolio also Includes measures that focus on pain management, appropriate treatment, and diagnostic Imaging. 48174 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices During the fall 2019 cycle. the Cancer Standing Committee evaluated eight measures undergoing maintenance review against NQF's measure evaluation criteria. All eight measures received endorsement. For the spring 2020 cycle. the Cancer Committee evaluated one measure undergoing maintenance review, which dl.d not meet the criteria for endorsement, No measures were submitted.to the Cancer Standing Committee for the fall 2020 cycle. Cardlollas.cutar Cardlo.vascular disease (CVD), which comprises coronary artery disease (CAD), heartfallure (HF), stroke, and hypertension, Is a significant burden In the us, leading to approximately one In four deaths per.year and affecting 48 percent of adults.age 20 years and older (BenJamtn et al., 2019; Heron, 2016). Considering the effect ofCVD, measures that assess cllnJcal care performance and patient outcomes are critical to reducing Its negative Impact. Heart disease Is the leading cause of death In the US and stroke Is the fifth leading cause (Heron, 2017). the Clrdlovascular portfollo contains 41 NQF:.endorsed measures, Including measures for acute myocardial Infarction {AMI), cardiac catheterlzatlon/percutaneous coronary Intervention (PCI),. CAD/lschemlc vascular disease (IVD), HF, hyperllpldemla, and hypertension. During thefall 2019 cycle. the cardlovascular Standing Committee evaluated one newly submitted measure and six measures undergoing maintenance .review against NQF's measure evaluation criteria. Four measures were. endorsed whlle three measures did not meet the.criteria for endorsement. These three measures did not pass the Performance Gap criterion due to a lack of performance data. For the sprJng 2020 cycle; four measures 1.1ndergolng maintenance review received endorsement. Two maintenance measures were reviewed during the fall 2020 cycle. The final endorsement decisions will be finalized In 2021. cost and Ef/klency In 2018,. healthcare spending In the US reached $3.6 trllllon, or approximately $11,172 per person (Medicare Payment Advisory Commission, 2020). This level of spending accounted for 17.7 percent of gross domestic product (GDP). Foretasts from 2018 to 2027 estimate that healthcare spending WIii outpace GDP growth by 0.8 percent. This lntrease WIii raise the health share of GDP from 17.9 percent In 2017 to 19.4 percent by 2027.(Medlcare Payment Advisory Commission, 2020), Spending on the overall Medicare program rs growing rapidly as well-from 15 percent of federal spending In 2018 to an expected 17 percent by 2027 (Medicare Payment Advisory Commission, 2020), Improving heillth system efflelency has the potential to simultaneously reduce the rate of cost growth and Improve the quality of care provided. Cost measures are the building blocks to efficiency and value. It rs Important to note that cost and resource use measures should be used In the context of and reported with quallty measures, The Cost and Efficiency measure portfolio contains 10 measures of cost and/or resource use that are both condition-specific (e.g., payments associated with 30-day episodes of care for pneumonia) and non-condition specific (e.g., Medicare Spending Per Beneficiary). · VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.029</GPH> lotter on DSK11XQN23PROD with NOTICES1 During the fall 2019 cycle, there were no measures submitted for evaluation. Rather, the Cost and Efficiency Standing Committee held a topical weblnar to examine validity testing With respect to cost measurement. For the ~prlng 2020 cycle, the Committee evaluated six new measures. Three measures received endorsement whlle the other three did not meet the criteria for endorsement. Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48175 One maintenance measure was reviewed during the fall 2020 cycle. The. final endorsement decision will be finalized In 2021. 6edatdC$. and Palliative Care tmprovtng the quality of both pa11latlve and end-of-life care, and geriatric care more generallv, Is becomlngJncreaslngly Important due to factors that have Intensified .the.need for lndlvlduall:ted, personcentered care; Some of these factors Include the. aging us population: the projected Increases In the number of Americans with chronic .illnesses; disabilities, and functional. limitations; and increases In ethnic and cultural diversity (Institute of Medicine; 2014), In 2018, the population age of 65 years and older numbered 52.4 mllflon IndlvldUals {16 percent of the us population), and this figure ls expected to increase to 94;7 million by 2060 {The Administration for Community Uving, 2020). Forty-six percent of the nonrnstltutlonalfzed US population age 65 years or older has two or three chronic conditions, and 15 percent has four or more; Additionally, 46 percent ofth(!Se whO are 75 years of age and older re.port lirnltations in physical functioning (the Administration forC:Ommunil:yUvfng, 2020; War:d & Schiller, 2013). NQF's cµrrentportfollo Includes 36endorsed measu~ addressing:~enence with care, care planning, pain manag:elt'M!nt, dyspnea management, care preferences, and quality of care at the end of lrfe. During the fall 2019 cycle. the Geriatric and Palliative Care standfng committee evaluated two measures undergoing maintenance review agalnst.NaF's measure evaluation Criteria. One measure was endorsed, whlle the other did not meet the measure evaluatlOn criteria. The Committee did not evaluate any measures during the spring 2020 cycle; Fout measures, all undetgoJfil maintenance; were reviewed dlli'lhl the fall 2020 cycle. The final endorsementdeclslons will be flnallzed lh 2021. Neurology NeurolOgical condltlonund Injuries affect nillllons of Americans each yea rand take a significant toll on patients, famlUes, and caregivers. Addltlonally, blllfons of dollars ai:-e spent on tr-eatment, rehabilitation, and lost or reduced earnlngs.(centers for Disease control and Prevention, 2020b). Stroke, a leading cause of neurological injury, is the fifth leading cause of death and disability in the US and is ranked as the second-leading cause of death worldwide (Centers for Disease control and Prevention, 2020b). Stroke remains a perslstentpubllc health concern and continues to present con11d.erable sociodemographic and economic implications natfonally,Alzheimer's.dlsease is the most common form of dementia, With an estimated flvemllllon Americans IMng with the disease. An estimated 14 mmron people.WIii have Alzheimer's by 20so; NQF's current Neurology portfolio lncludes.12 endorsed measures on the diagnosis ahd treatment of stroke and subarachnoid hemorrhage, as.well as carotid arterystenosis management, During the fall 2019 cycle. the Neurolcgy Standing committee reviewed two maintenance measures and recommended both measures for continued endorsement. The COmmltteedld not review any measures in the spring 2020¢Vcle. Therefore, NQF held a spring 2020topical webtnarto provide an update on the state of the current neurology portfolio. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.030</GPH> lotter on DSK11XQN23PROD with NOTICES1 one new measure was revJewed during the fall 2020 cyde. The final endorsement decision win be flnaflzed In 2021. 48176 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Patient Experience and Function The Implementation of patient-centered measures ls one of the most Important approaches to ensure that healthcare in the US reflects the goals, preferences, and values of care recipients. Patient· and family-engaged care ls planned, dellvered, managed, and continually Improved In active partnership with patlehts and their familles (or care partners as defined by the patient). As such, effective engaged care must adapt readily to individual and family circumstances, as well as differing cultures, languages, disabilities, health literacy levels, and socioeconomic backgrounds{Agencyfor Healthcare Research and Quality, 2018; Frampton et al., 2017). The coordination of care ls an essential component to the improvement of patient experiences and .outcomes, Poorly coordinated and fragmented care not only compromises the quality of care patients receive, but may also lead to negative unintended consequences, Including medication errors and preventable hospital admissions (Schultz et al., 2013). For patients living with multiple chronic conditions, Including more than two-thirds of Medicare beneficiaries, poor care transitions between different providers can contribute to poor outcomes and hospltallzatlons (Centers for Medicare & Medicaid Services, 2019a), The NQF Patient Experience and Function (PEF) Committee was established to evaluate measures within this topic area for NQF endorsement. NQF has endorsed over SO measures addressing patient experience of care, patient functional status, moblllty ahd self-care, shared decision making, patient activation, and care coordination. For the fall 2019 c:ycle, the PEF Committee reviewed two maintenance measures. The Committee recommended one measure for continued endorsement and did not recommend the second measure due to concerns related to data element level reliability, During the spring 2020 cycfe. the Committee evaluated one newly submitted measure and three measures undergoing maintenance review against NQF's measure evaluation criteria. All four measures received endorsement. Two new measures were reviewed during the fall 2020 cycle. The final endorsement decisions will be finalized In 2021. Patient Safety The Institute of Medicine (IOM) report, To E" Is Human: Building a Sa/er Health System, published In 2000, treated a movement by Individuals and Institutions to closely exam Ihe the avoidable harms In healthcare (Institute of Medicine (US) Committee on Quality of Health Care In America, 2000). These Included hospital-based medical errors, adverse drug events, Injuries from surgery, falls, pressure ulcers, and other causes of preventable morbidity and mortality. Despite 20 years of progress. since the publication of that report, medical errors and other patient safety events remain common across all settings of care. There has been demonstrated Improvement In specific areas, Including the reductloh of hospital-acquired Infections. However, the scale of Improvements lh patient safety has been llmlted. Many Interventions to Improve patient safety have been effective, but many others have proven Ineffective, and the effectiveness of many Interventions Is unclear. Nevertheless, the US healthcare system Is not a hlgh-rellablllty system. Today, patients commonly experience potentially preventable harm, and It Is estimated that medical errors are the third leading cause of deaths In the US, accounting for more than 250,000 deaths per year (Makary & Daniel, 2016). VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.031</GPH> lotter on DSK11XQN23PROD with NOTICES1 The NQF portfolfo. of safety measures contains 60 measures, spanning a variety of topical areas ahd Includes outcomes as well as Important, measurable processes In healthcare that are associated with patient safety, Public accountablllty and quality Improvement programs use many measures from the Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48177 NQF portfollo. OVer more than a decade, NQF's portfolio has expanded to address current and evolving publlc health Issues, such as the opioid crisis. As EH Rs have become Increasingly prevalent In healthcare, It Is Important to develop measures that monitor and Improve safety events that may be caused by the technology Itself, For the fall 2019 tytlg, the Patient Safety Standing Committee evaluated one newly submitted measure and three measures undergoing maintenance reVlew against NQF's standard evaluation criteria. The Committee recommended all four measures for endorsement. For the spring 2020. cycle. the Patient Safety Standing Committee evaluated one newly submitted measure and one measure undergoing maintenance review. Both measures received endorsement. Eight maintenance measures were reviewed during the fall 2020 cycle. The final endorsement decisions will be flnall2ed In 2021. Perinatal and Women's Health Access to high quality care for women of reproductive age before and between pregnancies-including pregnancy planning, contraception, and preconception care-can significantly reduce.the risk of pregnancy-related complicatlons, such as maternal and Infant mortality, and improve the overall health of women and children. Access is vitally important as the maternal mortality rate for Black women in 2018 was more than double. that of White women and three times the rate for Hispanic women (Hoyert & Mlnll'lo, 2020), Black patients also experience significantly more severe maternal morbidities than White patients (Howell et al., 2016). The Perinatal and Women's Health portfolio includes 18. endorsed measures on contraceptive care, reproductive health, pregnancy, labor and delivery, postpartum care for newborns, and childbirth• related Issues for women. During.the fall 2019 cycle. the Perinatal and Women's .Health Standing.Committee reviewed one measure for endorsement, which focused on contraceptive care. This measure received endorsement. For the spring 2020 cycle, the Committee evaluated six measures related to care delivered Immediately before and after birth, Including labor and delivery care, practices to promote positive health outcomes for mothers and Infants, and unexpected negative Infant health outcomes. All six measures received endorsement. One maintenance measure was reviewed during the fall 2020 cycle. The final endorsement decision will be flnallzed In 2021. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.032</GPH> lotter on DSK11XQN23PROD with NOTICES1 Prevention and Popu/otlon Health Traditionally, medical care has been the primary focus of efforts to Improve the health and well-being of lndlvlduals and populations •.As a result, nearly all national health expenditures have been attributed to healthcare services. Yet, medical care has a relatively small Influence on health outcomes when compared to Interventions that address smoking, lower educational attalnment, poverty, poor diet, and physical environmental hazards {e.g., unsafe housing and polluted air) {Eggleston & Finkelstein, 2014), There ls growing recognition of the role of social determinants of health (SDOH) In Influencing health outcomes, Maintaining and Improving the health and well-being of Individuals and populations wlll require a multldlsclpllnary, multlfactorlal approach to address SDOH (Office of Disease Prevention and Health Promotion, 2020), Performance measures are needed to assess Improvements In population health, as well as the extent to which healthcare stakeholders are using evidence-based strategies (e.g., 48178 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices prevention programs, screening, and assessments for community needs}. To support this effort, NQF endorses and malntalns perfotmance measures related to prevention and population hearth through a multlstakeholderConsensus Development Process(CDP}. The NQF Prevention and Population Health's portfolfo of measures Includes measures for health-related behaviors to prc,mote healthy living; CQmmunity-level ll'ldltators of health and disease; social, etonomrc, and environmental determinants of health; primary prevention and/or screening; and oral health. Durlngthefall 201!lcycle. the. Commfttee reviewed one maintenance measure and.two new composite measu~ for endorsement. One measure was endorsed whlfe the other measure did not meet the must-pi!Ss cl'iterla of the Quality Construct ofCo.mposlt!. For the spring 2020 cycle, the Commrttee reviewed two measures for maintenance of endorsement. One measure was endorsed; however, the second measure did not pass on valfdlty, a must-pass criterion •. One new composite measure was reviewed during the fall 2020 cycle. The fl rial endorsement detlslon wm be flnallzed rn 2021. Primary Core ilitd Cl,ronitlllness Primary tare providers serve as the most common healthcare contact point for many people within the US. As such, primary care has a central role In Improving the health of people and populations. Primary care practitioners work with eath patient to manage the health of that lndlvldual.. in the primary care settintJ, the diagnosis and treatment of the patientfocus on the health ofthe entire patient ilnd riot a slntJledfsease. Chronic mnessesare long~lastlng, or persistent health conditions or diseases that patients and providers must manage on an ongoing basis. The Incidence, Impact, and cost of chronic disease. ls increasintJ in the US. For example, more than 30 million Americans {9.4 percent} are living with diabetes, and in 2017~ the US spent $237 billion on diabetes care, makfng It one of the most expensive health condttlOhs (centers for Disease Control and Prevention, 2017). In addition, studies have estimated the yearly costs for glaucoma, rheumatoid arthritis, and hepatitis Cat $5.8 btlllon, $19.3 bllllon, and $6.5 billion, respectively (Birnbaum et al.,. 2010). The .review and evaluation of measures affecting primary care and deallng wlttrchronlc Illness have long been a priority of NQF, with endorsementfor such measures going back to Its inception. At present, there are 48 l>,IQF-endorsed Primary Care and Chronic Illness {PCCI) measures. The PCCI Committee oversees the measurement portfolio used to advance accountablllty and quality In the delivery ct primary care services. During the fan 1019 cycle. the PCCI Committee reviewed sfx maintenance measures fol' continued NClF endorsement. All siX measures retained endorsement. DUrintJthe spring 2020qcie. the Committee reviewed three new measures against NQF's measureevaluatlon criteria. All three measures did not meet validity, a must-pass criterion. This was due to concerns of a lack ofupper age llmlts for one measure, feasibility concerns related to a lack of options for primary care providers to meet one measure's numerator, and roncems related to the evidence base to supportanother measure. Seven measures, three maintenance and ft>ur new measures, were reviewed.during the fall 202() cycle. The flnalendorsement decfslons wur be flnallzed In 2021. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.033</GPH> lotter on DSK11XQN23PROD with NOTICES1 Renal Renal disease ts a leading cause of morbidity.and mortality In the OS.. More than 36 mllllon adults (14 percent of the adult population} have chronic kidney disease {CKD} (McCullough et al., 2019). Left Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48179 untreated, CKD can progress to an advanced state of kidney dysfunction known as end-stage renal disease (ESRD) and a host of other health compllcatlons, such as CVD, hyperllpldemla, anemia, and metabolic bone disease. Currently, over half a million people In the US have received a diagnosis of ESRD {Saran et al., 2019). Considering the high mortality rates and high healthcare utilization and costs associated with ESRD, the need to focus on quality measures for patients with renal disease Is of the highest Importance. Quallty measurement plays a central role In facilitating Improvement In the quality of care received by CKD patients, especially those on hemodlalysls {HD). NQF-endorsed kidney care measures are used in several quality and performance Improvement programs administered by CMS, such as Dlalysls Faclllty Compare and the ESRD Quality Incentive Program (ESRD QIP). The NQF Renal Committee seeks to identify and endorse performance measures for accountability and quality Improvement thataddress conditions, treatments, Interventions, or procedures relating to kidney disease. The Committee's portfolio of 21 measures consists of metrics focused on hemodlalysls access, monitoring, and outcomes, as well as various kidney-related treatments and safety considerations. During the fall 2019 cycle. the Renal Committee evaluated one maintenance measure for continued NQF endorsement. This measure retained Its endorsement status. For the spring 2020 cycle, the Standing Committee evaluated three measures undergoing maintenance review against NQF's standard evaluation criteria. Two measures were endorsed, while one measure did not receive endorsement due to Insufficient evidence to support the measure focus. Two measures, one new and one maintenance, were reviewed during the fall 2020 cycle. The final endorsement decisions will be finalized In 2021. surgery In 2014, there were 17.2 million hospital visits that included at least one surgery. Of these surgeries, over half of them occurred in a hospital-owned ambulatory surgical center (Steiner et al., 2020). Quality measurement In surgery is essential to Improve outcomes for the millions of Individuals undergoing surgery and surgical procedures each year. The Surgery measure portfolio includes 66 measures that address surgical care, Including perioperatlve safety, general surgery, and a range of specialty surgeries. During the fall 2019 cycle, the Surgery Committee evaluated one measure undergoing maintenance review against NQF's measure evaluation criteria. This measure was endorsed. For the spring 2020 cycle. the Committee evaluated one measure undergoing maintenance review. This measure retained Its endorsement status. Eight measures, all undergoing maintenance, were reviewed during the fall 2020 cycle. The final endorsement decisions will be finalized in 2021. v. Stakeholder Recommendations on Quality and Efficiency Measures and National Priorities VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.034</GPH> lotter on DSK11XQN23PROD with NOTICES1 Section 1890{b)(7)(A){I) of the Act requires the CBE to convene multistakeholder groups to provide input on the selection of certain quality and efficiency measures from among: (i) such measures that have been endorsed by the CBE; and (If) such measures that have not been considered tor endorsement by the CBE but are used or proposed to be used by the Secretary for the collection or reporting of quality and 48180 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices efficiency measures. Additionally, CBE must convenemu/tistakeholder groups to provide fnput on national pr/oritiestor Improvement In population health andln de/Ne,v of health core serwcesfor consideration under the National Quality Strategy. The CSE Is required to describe these duties In this report pursuant to section 1890{b)(S)(A1(i)(VI) of the Act. Measure Applications Partnership Under.sectlon1890A(a)ofthe Act, HHS ls required to establish a pre-rulemaklng process underwhfch the CSE would convene mu/tistakeholdergroups to provldt! Input to the Secretary on the selection of quality and efficiency measuresfor useln certain federal programs. The list ofquallty and efficiency measures HHS ls considering.for selection Is to be publicly published no later than December 1·ofeach year, No tater than February 1 of each year, the CBE1s to repart the input of the multistakeholdet groups, which wlll be considered by HHS In the selection ofquality ande[flelency measures. Since Its Inception rn 2011,. NQf has cc>nvened the Measure Applications Partnership {MAP) tc> provide guidance on the use of performance measures In federal healthcare quaflty programs. These recommendations are made by MAP through its pre-rulemaking process, which enables a multistakehokfer dialogue to assess measurement ptioritfesforthese programs. MAP Includes representation from both the public and private sectors and Includes patients, clinicians; providers, purthasers,.and. payers. MAP reviews measures. that CMS fs considering fur implementation and provides guidance on their acceptability and value to stakeholders. MAP Is composed of three setting-specific workgroups (Hospital, cIInIc1an, and POst-ACtlte/lol'li-'Wrm Care), one populatlon-speclflc workgroup {Rural Health), and a Coordinating Committee that provides strategic guidance and oversight to the.workgroups and recommendations. MAP membership rs representative Of users.of performance measures and over 1as healthcare leaders from 90 organizations. MAP conducts Its pre-rulemaldng work In an open and transparent proc;ess; as the 11st of Measures Under Consideration (MUCs) Is posted publicly, MAP deliberations are open to the public, and the process allows for the submission of both oral and wl'ltten public comments. to Inform MAP considerations:. MAP's aim IS to provide tnputto CMS that ensures the measures used In federal programs are meimlngful to all stakeholders. MAP focuses on recommending measures that empower patients to be active healthcare consumers and supports their decision maklng;.are not overly burdensome on providers; and can support the transition to a system that pays for value of care. MAP strives to recommend measures thatwlll enhance quality for all A~rlcans While ensuring that the transitiOn to value~based payment(VBP).and alternative payment rriodels {APMs) brings better care arid access while reducing costs for all. MAP 2')19-2020 Pre-Ruleinaklng Recommendations VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.035</GPH> lotter on DSK11XQN23PROD with NOTICES1 MAP published the results of Its 2019-2020 pre--rulernakrng dellberattons In a sel'ies of reports delivered In February and March 2020. MAP made recommendations on 18 meiisures under consideration for nine CMS quality reporting and VBP programs covering ambulatory, acute, and post-acute/long-term care settings. A summary of this work Is provided below; Jn addition, MAP began Its 2020~2021 pre-rulemaklng efforts In December 2020 to provide Input on 20 measures under consideration for eight CMS programs. final recommendations along with a detailed report are expected iri February 2021. Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48181 MAP's pre-rulemaklng recommendations reflect Its M11asure Selection <;;rltecla and how well MAP belleves a measure under consideration (MUC)flts the needs of the specified progtam. The MAP Measure Selection Criteria are designed to demonstrate the characteristics ofan Ideal set of performance measures. MAP underscores the need for evidence-based,. scientlflcally sound. measures while minimizing the butden of measurement by fostering alignment and ensuring measures are feasible. Moreover, MAP promotes alfgnment across the public and private sectors, person-centered measurement; and the reduction ofhealthcare disparities. MAP Rural Health Workgroup As recommended In the 2015 NQF report on Rural Health, NQF reconvened the MAP Rural Health Workgroup In the fall of 2019 to provide Input Into the CMS annual pre-rulemaklng proces$. 'This workgroup consists ofexperts In rural health, frontllne healthcare providers who serve In rural arid frontier areas, Including tribal areas and patients from these areas. The role ofthe workgroup Is to provide rural perspectives on measure selection for CMS program use. This Includes noting measures. that are challenges for rural providers to collect data on or report. about and any unintended consequences for rural providers and residents. The Rural Workgroup reviewed and discussed this year's MUCs for various CMS quality programs. NQF provided a written summary of the workgroup's feedback to the Hospital, Cllnlclan, and PAC/LTC Workgroups to aid In their review ofthe measures. To provide a.ddltlonal Input and represent the rural perspective, a IlaIson from the Rural Workgroup attended each of the setting-specific workgroup meetings. several themes emerged that should be considered when assessing qualltv In the rural settings: a shortage of behavioral health spec!allsts creating a challenge for ensuring timely follow-up for behavioral health appointments; dlfflcultles In Information exchange at some rural facllltles due to a lack of Integrated data systems, cost of eCQM reporting Infrastructure, and reporting rules that a.re difficult for rural providers to meet. Addlt!onally, the workgroup not.ed that there may be a lack of transportation options for patients In rural settings, so telehealth options for medical visits are especially pertinent for patients In. this setting. Low case-volume co.ntlnues to be a challenge for performance measurement In rural.areas. MAP C:llnldan Workgroup 'The MAP Cllnlclan Workgroup reviewed 10 MUCs from the 201911st for three programs (listed below) addressing health plan, cllnlclan, or accountable care organization (ACO) measurement, making the following recommendations organ12ed by program. Merit-Based Incentive Paytnent System (MIPS) - MIPS was establlshed by.section 101(c)of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MIPS Is a pay-for-performance program for ellglble clinicians and applies positive, neutral, and negailve adjustments to Part B payments for covered pr.ofesslonal services furnished by MIPS eligible cllnlclans based on performance In four categories: quality, cost, promoting lnteroperablllty, and Improvement activities. MIPS Is one of two tracks In the Quallty Payment Program (QPP). MAP revlewe~ four measures for MIPS and made the following recommendations: lotter on DSK11XQN23PROD with NOTICES1 • VerDate Sep<11>2014 Support. MAP supported one measure for rulemaklng related to total hip and total knee arthroplasty, Condltlonal Support. MAP conditionally supported two measures pending receipt of NQF endorsement. The two measures were related to all-cause hospital admissions and appropriate vascular access for hemodlalysls, 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.036</GPH> • 48182 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices • No Support With Potential for Mitigation. There was one measure considered that MAP did not support for rulemaklng with potential for mitigation. This measure was associated with hospital admissions for patients with multiple chronic conditions, Within the MIPS measure set, MAP Identified several gaps, speclflcally in the areas of primary care1 access, continuity, cQmprehenslon, and care coordination.. MAP atso.sugg~ted that CMS consider adding measures that determine whether a course of therapy is indeed the bestfor the patient to optimize reductlcms Tn cost and harm. MAP also emphasized measures of diagnostic accuracy and primary care PROMs. Measures for MIPS on the 2019 MOC llstwere under consideration for petentlal rmptementatlon In the 2021 measure set, affecting the 2023 payment year and future years. Medicare Shared Savlnas Prosrarn - Sectlon 3022 of the Affordable care Act (ACA} treated the Medicare Shared Savings Program. The Shared SaVlngs Program creates a voluntary opportunity for providers and suppliers to longltudlnally manage the. care and costs of Medicare beneficiaries under an ACO model. An ACO ls responSlble for the cost and quaUtY Qf carder an assigned POPi.lll!tlon of Medicare fee-tors service beneficiaries. The Shared Savings Program alms to promote accountablllty for a patient populatlon, care coordination, and the use of high quality and efficient services. ACOs have multiple options for participation tracks Within the Shared Savings Program, allowlng for variation In organizational capablllty to assume risk, In its 2019-2020 pre-rulemaklng work, MAP considered one measure for the Shared SaVlngs Program. MAP condltlonally supPQrted a measure related to hospital admissions for patients with multiple chn;mlc conditions, pending NQf endorsement. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.037</GPH> lotter on DSK11XQN23PROD with NOTICES1 Medicare Pan Cand DStar Ratlnas- Each year, CMS publishes the Medicare Part C and DStar Ratings that measure the quality of the Medicare Advantage (MA) (or Part c plans). and Prescription Drug Plans (PDPs or Part Dplans). These Star Ratings serve.several purPQses, Including to provlde comparative InfotmatlOli to beneficiaries about the plans~ to provide quality ratings used to determine ellglblllty of Part Cplansfor quality bonuses, and.to proVlde a means to evaluate and oversee overall compliance with certain regulatory provlsions. The Star Ratlngs also reflect the experiences of beneficiaries and assist beneficiaries In finding the best plan for them. The Star Ratings support CMS' efforts to putthe patient first. As part of this effort, patients should be empowered to work with their healthcare providers to make healthcare decisions that are best for them. An lmPQrtant component of this effort Is to provide Medicare beneficiaries and their family members wlth meanlngM Information about quality and cost to assist them In becoming Informed and active healthcare consumers. In 2019, approximately 66 mlllion Americans were enrQlled in Medicare; with 34 percentof beneficiaries in a Part Cplan. The Part c and DStar R-atli'lg Program t0ns1sts of 48 quality and performance measures; MA•only contracts (without prescription drug ti>verage) are rated on up to 34 measures and stand-atone PDP contracts are rated on up to 14 measures. Each year, CMS conducts a comprehensive ntView of the measQres that makeup the Star Ratings byassesslng therellabilltyofthe data, cllnlcal recommendations,. and feedback recefved from stakeholders. Star Ratings are used fol' purposes, Including public reporting on Medicare Plan Flnder,.health plan quality Improvement; marketing, and enrollment~ as well as forflnantlal incentives. Per theACA:, CMS makes quality bonus payments {Q.BPs) to MA organizations that meet certain quality ratings measured using a flve'-Starquailty ratlng system, MA rebate levels for plans are tied to the contract's Star Rating. QBPs are not connected to the PDP program, only MA. Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48183 During this Inaugural year of MAP's review of Part C and D measures under consideration, MAP discussed five measures with the following recommendations: • • • ~ . MAP supported two measures for rulemaklng related to opioid prescribing practices. COndltlonal Support. MAP condltlonally supported two measures pending receipt of NQf endorsement. The two measureswere related to follow-up after ED care and care transitions. No Support. There was one measure considered that MAP did not support related to opioid prescribing practices. Key Themes From the ainlcian Workgroup Pre-Rulemaking Review Process-Two key overarching themes emerged from MAP's pre-rule making recommendations for measures 111 the MIPS, the Shared Savings Program and the Part C and D Star Ratings. First, MAP emphasized the Importance of shared accountability for performance measures of avoidable hospital admissions,. readmissions, and ED use that are Incorporated Into public reporting and payment programs. Cllnlclans and health systems have the potential to Implement care Interventions thatcan offset disease progression and reduce high-cost, low-efficiency healthcare. Measures of patient outcomes require balancing the goals of shared accountablllty of cllnlclans and health systems, and appropriate attribution of outcomes that can be Influenced by each entity. MAP expressed concern that many care coordination measures are process measures that assess steps along a patient episode of care. but do not measure If all care Is coordinated through a centralized and shared care plan for the patient. MAP also acknowledged that these measures may be appropriate In early stages of transition toward truly coordinated, holistic, and lndlvlduallzed care. MAP recognized that addressing social determinants is a critical element to effective tare coordination for patient transitions. However, MAP also noted the challenges with addressing these soelal determinants through measurement. Patient outcomes may be Influenced by a patient's health status and sociodemographic factors, In addition to healthcare servlces,.treatments, and Interventions. MAP acknowledged that data limitations and data collection burden may limit risk adjustment, but measures of accountablllty should monitor for any Incorrect Inferences about provider performance. Clinicians and health systems need Information to understand differences In outcomes among patient cohorts to drive improvement, but MAP suggested caution on performance assessments involving social determinants. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.038</GPH> lotter on DSK11XQN23PROD with NOTICES1 Second, MAP discussed the need for appropriate measures to address the opioid crisis. MAP noted that the current phase of the opioid crisis ls predominantly driven by an Increased uptake of fentanyl-laced heroin, leading to increases In ovetdose and death. MAP acknowledged an important shared responslblllty for lndlvldual providers, health systems, and health plans to address Issues of pain management and function as well as to Identify and address Issues associated with opioid use disorder (OUD). MAP emphasized that the proper metrics need to be applied across the US healthcare system such that opioid overdose deaths continue to decline In a manner that is verifiable. Furthermore, the metrics applied must minimize undesirable consequences, such as needless suffering from pain, Increases In other substance use disorders, or transitioning from prescription to Illegal drugs because of being unable to obtain appropriate pain medication. This includes the need for Increased, appropriate to-prescribing of Naloxone with oplolds (for pain or for persons with OUD). Similarly, MAP called for better lnltlal prescribing measures to balance appropriate use of oplolds for pain management with associated risks. Additionally, MAP Identified the need in federal quality and performance programs to Include new measures that assess patient-centered analgesia treatment planning, Including appropriate 48184 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices tapering strategies to reasQnably decrease or discontinue opioid treatment, measures of long-term recovery from OUD, and measures.of physical and mental health comorbldltleswlth OUD. These overarching themes emphasize the significance of care coordination and attribution as well as appropriate oplold measurement. MAP HO$pibll Worqroup The MAP Hospital Workgroup reviewed six MUC:S from the 201911st for four hospital and other settingspecific programs, making the following reCQmmendations. End-Staie Renal Disease (ESRD) Quallty Improvement: Proaram • The End-Stage Renal Disease Quality Incentive Program (ESRD QIP) rs a VBP program established to promote the pro'itlslon.ofhlgh qualliy renal dialysis services by dialysis facllltles~ Payments.to a dialysis facillty under the ESRD. Prospective Payment System (Pi>S} are reduced for a calendar year If the faclUty does not meet or exceed the minimum total performance score thatapplies to the program year. Payment reductions are made 011 a sliding scale depending on the facility's performance; With a maximum two percent reduction per year. MAP reviewed a single measure for the program arid offered condltlonal support pending NQF endorsement. The measure Is related to transfusion ratios for patients on dialysis and calculates a rlskadjustea standardized transfusion ration (STrR) for each dialysis facility specified for all adult dialysis patients. Inpatient Psychiatric Faclllty Quality Improvement Projram- The tnpatlent Psychiatric Facmiy auanw Reporting Program (IPFQR) Is a pay-for--reportlngprogram. The program's goal ls to provide consumers with qua1lty"Of-care information to make informed decisions about healthcare options and to encou~e hospitals and cllnTclans. to Improve the quality of Inpatient psychiatric care by ensuring that providers are aware of and reporting on best practices. MAP considered a single measure for potential inclusion in the IPFQR program related to follow-up after psychfattic discharge. MAPconditlonally supported the measure for rulemakfng pending NQF endorsement. Hospital lnpatrent Quality Reporting (iQR-) Procram - The Hospital Inpatient Quallty Reporting (IQR) Program Is a pay-foNeportlng program that requires hospitals paid under.the lnpattent Prospective PaymentSystem {IPPS} to report on vanous measures; this Includes process,.structure, outcome, and patient perspective on care;. efficiency, and costs-of-care measures. HOspit:als that do not participate or meet program requirements have an applicable percentage Increase that Is reduced by one,-quarter. The goals of the Hospital IQR Program are two,fold: (i)to provide an Incentive for hospltalsto report. quality Information about their seMces. and (2} to provtde consumers with Information abouthospltal quaniy so that they.can make Informed choices about their care. MAP reviewed two measures under consrderatlon for the Hospital IQ.R Program related to hospital harm and maternal morbidltY an.d offered conditional support for both pending NQF revlew and endorsement. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.039</GPH> lotter on DSK11XQN23PROD with NOTICES1 MAP did not re"iew any measures tor the Medicare and Medicaid EHR Promoting lnteroperabllitY Program for EtlglbleHospltals and CritlcalAcceSs Hospitals for.endorsement. Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48185 PPS-Exempt Cancer Hospital Quality Reporting Program • The Prospective Payment System {PPS):El<empt cancer Hospital Quality Reporting (PCHQR) Program ts a quality reporting program for PPSexempt cancer hospitals. The program's goal Is to provide Information about the quality of care In the 11 cancer hospitals that are exempt from the Medicare Inpatient Prospective i>ayment System. tn lts20i9•2020 pre-rulemaklng deliberatlons, MAP reviewed two patient safety measures under consideration for the PCHQ.R program related to Infections from central llnes and catheters. MAP supported both measures for rulemaklng. Key Themes From the Hospital WOrqroup Pre-Rulernaklng Review Pi'OceQ-Major themes from the MAP Hospital Workgroup dlscusslo.ns centered around the need for patlent safety measures and the Importance of a.systems view for measurement. MAP high lighted the need for patient.safety measures for each of the hospital and setting-specific program dlscussfons. Patlentsafety-related events occur across.healthcare settings and Include healthcare-associated Infections, medication errors, and other potentially avoidable events. The measures considered by. MAP spanned a variety of patient safety topic areas, Including preventable rnfettlon, preventable blood transfusion, reducing maternal morbidity, reducing hyperglycemia events, and preventing harm through follow-up post-discharge. MAP emphasized that patients and consumers value patient safety.measures Tn publicaccountabi!ltyprograms, and facilities can improve patient safety through quality Improvement programs. Even for measures MAP considered this cycle but ultimately did not support, MAP members stressed the lmportance of each overall patient safetyquallty. concept and the quality: Improvement activities .thatthe measure would encourage. MAP also discussecl the need fQr using a svstem-lwel measurement approach to capture the patient episode of care, Identifying priorities In measurement across settings and determining the appropl'late accountable entity and setting. Measures specified for a single care setting that address system0 1evel iSsueswith shared accountability, such as follow-up visits and transitions of care; l)OSe chaltenaes in determining which entity should be measured and how•. MAP concluded that.while It Is necessary to review measures using a setting-specific. approach, there is also a need to examine measures from a system-level perspective; MAP noted thatasystem-level approach also re,u,res the transfer Of health information and use of eCQMs. MAP supported CMS' efforts to drive towards digital measures and cited eCQMsas one.tool to assist ln the reduction of measurementburden. MAP PAC/LTC Workgroup MAP reviewed two measures under consideration from the 2019 11st for two setting-specific federal programs addressing post-acutet:are (PAC} and long-term care {LTC). Four programs did not have measures for review. MAP made the fol!owfng recommendations. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.040</GPH> lotter on DSK11XQN23PROD with NOTICES1 Home fh:alth Quallty Reportffll Program (HH QRP) - EstabliShed in accorciancewlth section 1895(b}{3}(B}{v)of the SocialSecut!ty.Att, the Home Health 0.u'allty Repoltlng .Program (HH QRP) requires home health agendes.{HHAs} to submit HH 0.RP data appropriate for the measurement of healthcare qualltV. Sources of this data.may lndude the Outcome and Assessmen.t Information Set (OASIS} and the Home Health care Consumer Assessment of Healthcare Providers and Systems survey (HH CAMPS•). HHAs that do not submit the data are subjectJo a two percent reductionJn the annual home health market basket percentage Increase. 48186 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices MAP reviewed one measure under consideration for the HH QRP: Home Health Within-Stay Potent/ally Preventable Hospitalization. MAP condltlonally supported this measure pending NQF endorsement. MAP noted that the measure adds value to the HH QRP measure set by adding an assessment of potentially preventable hospltallzatlons and observation stays that may occur at any point In the home health stay. No measure In the program currently provides this Information. The measure supports alignment for the measure focus area of admissions and readmissions across care settings and providers. MAP encouraged consideration of including MA patients in future iterations of the measure. Hospice Quality Reponlns Pros,am (HQRP) - The Hospice Quality Reporting Program (HQRP) was established under section 3004 of the ACA and applies to all hospices, regardless of setting. Under this program, hospice providers must submit quality reporting data from sources such as the Hospice Consumer Assessment of Healthcare Providers and Systems survey (CAHPS Hospice survey) and the Hospice Item Set (HIS) data collection tool, or be subject to a two percent reduction In the applicable annual payment update. MAP reviewed one measure under consideration for the HQRP: Hospice Visits In the Last Days of Life. MAP conditionally supported this. measure pending NQF endorsement and the removal of the existing hospice visit measures from the program. Generally, MAP agreed that collecting Information about hospice staff visits will encourage hospices to visit patients and caregivers, provide services that will address their care needs, and Improve quallty of life during the patient's last days of life. MAP observed that the measure under consideration performed better In validity and rellablllty testing and has lower provider burden than the existing program measures because It ls reported using clal.ms data. MAP agreed that the goal of hospice ls comfort. MAP suggested that future Iterations of this measure consider the quality of provider visits In addition to the quantity of visits. Key Themes From the PAC/LTC Workgroup Pre-Rulemaklng Review Process - MAP noted that patients requiring post-acute and long-term care are cllnlcally complex, and therefore may frequently transition across sites of care. MAP's discussion of the PAC/LTC settings and programs focused on the followlng themes: capturing the voice of patients through PRO-PMs, making EHRs and eCQMs more useful,.and Identifying measurement opportunities for the PAC/LTC population. MAP Identified PROs as one of the most Important priorities for PAC/LTC programs. Thoughtfully soliciting and Incorporating the voice of the patient Into quality measurement wlll contribute to the alignment of care with patient goals and preferences. MAP members noted that traditional care goals focusing on Improvement In function and health status may not be appropriate for the entire PAC/LTC population. The goal of care may be maintaining current functional status, llmltlng decllne, and/or maidmlzlng comfort. Assessment and measurement of patient goals should be an Important focus In this population. MAP recommended thoughtful consideration around the burden associated with PRO completion. This burden should be balanced with the goal of providing Information that Is useful to patients In selecting providers and for providers to understand how to Improve care. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.041</GPH> lotter on DSK11XQN23PROD with NOTICES1 Patients who receive care from PAC and LTC providers frequently transition among multiple sites of care. Patients may move among their homes, the hospital, and other PAC or LTC settings as their health and functional status change. Improving care coordination and quality-of-care transitions ls essential to Improving PAC and LTC. MAP identified care coordination as the highest priority measure gap for PAC/LTC programs. MAP pointed out the potential of health Information technology {IT) to Improve qualfty and minimize the burden of measurement. MAP members noted that EHR adoption In PAC/LTC Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48187 settings often lags other care settings since PAC/LTC settings have had fewer Incentives to Implement new technology. Increased. use of technology could help to Improve transitions and the exchange of information across providers. MAP supported CMS in its effort to improve standardization and promote lnteroperablllty, speclflcally Health Level Seven's (HL7) Fast Health lnteroperablllty Resources (FHIR) standards. MAP recommended that CMS work with vendors to Improve EHR Interoperability; Prioritizing Interoperability across care settings will maximize its impact by allowing more organizations to share and receive data. MAP members also cautioned about potential burden introduced through technology. Specifically, MAP encouraged CMS. to monitor the Impact of auto-populating EHRs to fulfill regulatory or other nonclinical requirements. This add.ltlonal auto-populated Information can crowd out or obscure critical clinical information. MAP Identified nine concepts for measurement Within all PAC/LTC programs: {1) access to care, {2) care coordination, (3) chronic lllr1eu care (quality of life), {4) lnteroperablllty, (5) mental health, {6) pain management, (7) PROs, (8) social determinants, and (9) serious illness. MAP then prioritized the list, allowing each voting member to present two votes. The voting Identified care coordination, lnteroperablllty, and PROs as the most Important priorities for measurement for PAC/LTC programs. These key overarching themes hlghllght the Importance of Including the voice of the patient and patient· centered goals, the impact of technology and Interoperability, and measurement opportunities for the PAC/LTC population. Core Quality Measures Collaborative-Private and Public Alignment Using performance measures as part of value-based models incentlvlzes the delivery of high quality care. Increasing the use of measure In various models, however, has also led to measure proliferation, operational dlfflcultles, and confusion In interpreting measure results. The Core Quallty Measures Collaborative (CQMC) is working to reduce measurement burden by facilitating cross-payer measure alignment through the development and adoption of core measure sets to assess the quality of US healthcare. The CQ.MC Is a membership-driven Initiative with over 70 organizations, Including CMS, health insurance providers, primary care and specialty societies, and consumer and employer groups. In 2020, NQF convened 11 multlstakeholderworkgroups to update eight current core sets1 create two new core sets In priority cllnlcal areas, and develop an Implementation guide to support adoption across payers. NQF also analyzed core set measure gaps to support actions and priorities of the CQMC for coming years. The CQMC defines a core measure set as a parsimonious group of scientifically sound measures that efficiently promote a patient-centered assessment of quality and should be prioritized for adoption in VBP programs and APMs. To date, the CQ.MC has chosen to focus on cllnlclan measurement, primarily In the outpatient setting, and to Identify core sets that could support multiple care delivery models. Core sets are updated to include high•priority, evidence-based measures that arefeasible to implement and that can drive the most Improvement. The CQ.MC prioritizes outcome measures, lncludlng patientreported measures, and dlgltal measure and aims to continue to advance alignment of private and public payer modelsthat use these measure types. In 2020, NQF updated the following eight core sets using a multlstakeholder process and measyre selectlgn prlnclples: VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.042</GPH> lotter on DSK11XQN23PROD with NOTICES1 1. Accountable Care Organizations (ACOs), Patient Centered Medical Homes (PCMH) and Primary Care 2, Cardiology 3, Gastroenterology 48188 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 4. HIV and Hepatitis C 5. Medical Oncology 6. Obstetrics and Gynecology 7. Orthopedics 8. Pediatrics In 2020, new core sets were developed for Behavi.oral Health and Neurology clinical areas. While progress has been made updating the core sets and creating new ones, several areas In measurement gaps remain. The CQMC published a Gaps Analysis report to hlghllght cross-cutting gaps across the core sets as well as specific gap areas relevant to each clinical topic area. The CQMC Implementation Gulde Identifies key components of successful value-based payment programs and synthesizes strategies and resources to help organizations succeed In their adoption. This guide outllnes four elements of successful value-based payment Implementation: {1) Leadership and Planning; {2) Stakeholder Engagement and Partnership; (3) Measure Alignment; and (4) Data and Quality Improvement Support. Payers and other stakeholders can use the implementation strategies to design, refine, strengthen, and extend value-based payment initiatives. The CQMC's activities will continue into 2021. This work will address gaps (e.g., digital quality measures), continue to advance the core sets by including new measures and removing measures as needed, and focus on measurement of cross-cutting topics (e.g., safety, access). In addition, the CQMC will create strategies for measurement model alignment to promote greater communication and reporting of core set measures. More Information on the Collaborative can be found at the website: https://www.gualityforum.org/cgmc/. VI. Gaps In Endorsed Quality and Efficiency Measures Under section 1890{b}(S}(A)(l)(IV) of the Act, the CBE ls required to describe In this report gaps In endorsed quality and efficiency measures, including measures within priority areas identified by HHS under the agency's National Quality Strategy, and where quality and efficiency measures are unavailable or Inadequate to identify or address such gaps. Gaps Identified In 2020 Completed Projects During their deliberations, NQF's endorsement Standing Committees discussed and Identified gaps that exist In current project measure portfolios. A list of the gaps identified by these Committees In 2020 can be found In Appendix G. Measure Applications Partnership: Identifying and FIIHng Measure Gaps VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.043</GPH> lotter on DSK11XQN23PROD with NOTICES1 In addition to Its role of recommending measures for potentlal Inclusion Into federal programs, MAP also provides guidance on identified measurement gaps at the Individual federal program level. In Its 2019-2020 pre-rulemaklng deliberations, MAP specifically addressed the high-priority domains CMS Identified In each of the federal programs for future measure consideration. A list of gaps Identified by CMS program can be found In Appendix H. Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices VII. 48189 Gaps In Evidence and Targeted Research Needs Under section 1890(b){S)(A)(i)(V) of the Act, the CBE is required to describe areas In which evidence is lnsufflc/ent to support endorsement of quality and efficiency measures In priority areas Identified by the Secretary under the Notional Quality Strategy and where targeted research may address such gaps. NQF undertook several projects In 2020 to create strategic approaches, or frameworks, to measure quallty In areas critical to Improving health and healthcare for the nation but for which quallty measures are too few, underdeveloped, or nonexistent. A measurementframework Is a conceptual model for organizing Ideas that are Important to measure for a topic area and for describing how measurement should take place (I.e., whose performance should be measured, care settings where measurement ls needed, when measurement should occur, or which Individuals should be included in measurement). Frameworks provide a structure for organizing currently available measures, areas where gaps exist, and prioritization for future measure development. NQF's foundational frameworks identify and address measurement gilps iii Important healthcare areas; underpin future efforts to Improve quality through metrics; and ensure safer, patient-centered, and cost~effective care that reflects current science and evidence. In 2020, NQF continued efforts on several projects focused on creating strategic measurement frameworks for maternal morbidity and mortality, person-centered planning and practice, measure feedback loop, PROs, EHR data quality, common formats for patient safety, and reducing diagnostic error. In addition, NQF Initiated work on five new strategic measurement frameworks addressing attribution, rural health, oplolds, behavioral health, EHRsourced measures for care coordination, and PRO-PMs. Attribution-Critical Illness/Injury As mentioned earller, the Attribution for Critical Illness and Injury project seeks to address the challenges of lmprovfng health outcomes during emergencies. While the healthcare system moves towards value-based design, measurement attribution approaches must continue to evolve. Attribution ls defined as the methodology used to asslgri patients, and their quallty outcomes, to providers or cllnlclans {National Quality Forum, 2016). To date, attribution models mainly focus on care for chronic conditions coordinated through a central unit, when most patients usually seek care from a usual source. High-acuity emergency care-sensitive conditions {ECSCs) (Carr et al., 2010), such as critical illness or Injury, Infectious diseases, and other public. health emergencies that result in mass casualty and sudden surge of severely Injured or Infected patients, require prompt, team•based care. The COVID-19 pandemic underscores the complexities associated with attributing patients during public health emergencies. Factors such as resource avallabllity, different entitles providing care, communication of test results and patient needs, and orders that aim to minimize Infection spread may all affect health outcomes. These attribution models may not be applicable to care delivery in public health emergenc:tes. Identifying all providers who took part In treatment, differentiating their performance, and linking It to patient outcomes ls technically complex. As evidence to support the best models of attribution for ECSCs Is limited, defining the elements of such models and developing consensus-based recommendations will help advance the measurement field. This project aims to provide foundational guidance for attributing care and payr11ent In areas that have not previously been addressed. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.044</GPH> lotter on DSK11XQN23PROD with NOTICES1 This work builds upon previously CMS funded work, NQF's 2016 Attribution: Principles and Approaches (National Quality Forum, 2016) and 2018 lmproylng Attribution Models (National. Quality Forum, 2018), 48190 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices as well as the Health Care Payment Leaming &Action Network (HCP-LAN)'s 2016 Report on Patient Attribution (Health care Payment Learning and Action Network, 2016). It will consider NQF's 2019 Healthcare System Readiness Measurement Framework that puts forth approaches to assess care delivery and the organization of resources prior to, during, and after emergencies {National Quality Forum, 2019). NQF convened a multistakeholder Committee in late 2020. In 2021, the Committee will develop recommendations to guide future development of population-based attribution models for high-acuity ECSCs that can be used to strengthen accountability at the system level to Improve patient outcomes. Leveraging Electronic Health Record (EHR)-Sourced Measures to Improve Care Communication and Coordination The goals of care communication and coordination efforts are to ensure that patient care that is delivered across multiple clinlclans Is synchronized and efficient. Effective care coordination Involves seamless communication between each clinician, patient, and caregiver, as well as their famllles, particularly at transitions in care. In coordinated care, healthcare teams should strive to understand and Implement a cohesive care plan where goals do not change as the patient moves from setting to setting (Williams, 2020). Unfortunately, much of American healthcare today Is not well coordinated. Patients often experience poor transitions In care between settings. There also may be duplicative testing and treatment plans that increase patient risks, including drug interactions. Clinicians may observe that a patient is directed to the Incorrect place In the healthcare system or experiences a poor outcome from Inadequate Information exchange between clinicians. They may also experience unreasonable levels of effort to accomplish coordination during transitions In care. It has also been noted that healthcare organizations Implement coordinated care unevenly and inconsistently. A recent survey found that only seven percent of patient care Is coordinated across settings (Abbaszade et al., 2020). In the 2014 Agency for Health Research and Quality (AHRQ), the Care Coordination Measurement Framework stated that care coordination can be measured through the presence or absence of specific coordination activities (e.g., creating a plan of care) or broad approaches (e.g., using care management) (Agency for Healthcare Research and Quality, 2014). The effects of care coordination can be measured as the presence or absence of a clinical event (e.g., a diagnostic error) or perception of coordination of care from the perspective of patients, clinlclans, or health systems (Weston et al., 2017). However, measuring care coordination has been challenging with existing quality measures. Measurement thus far has focused on Isolated coordination processes or activities as these processes or actlVltles may be difficult to precisely replicate across settings as their success may be context dependent (i.e., working In one setting but not another). Additionally, there is a paucity of outcome-based measures in care coordination against which to measure program success. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.045</GPH> lotter on DSK11XQN23PROD with NOTICES1 EHRs have emerged as an important data source for quality measures as the ability of EHR systems to connect and exchange data is an important aspect of quality healthcare that has not been fully realized. EHR data are primarily designed to support patient care and bllllng, not necessarily capture data for secondary uses, such as quality measurement. However, within EHRs, technology tools and specific design features have been effectively deployed to help facilitate care coordination. This allows EH Rs to serve as a way to improve both care coordination and how It Is measured. Under this task order, NQF will convene a multlstakeholder Committee to Identify best practices to leverage EHR-sourced measures 48191 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices to improve care communication and coordination quality measurement in an all-payer, cross-setting, and fully electronic manner. In the initial year, NQF will perform an environmental scan to review, analyze, and synthesize the Information from a literature review, expert interviews, and measure review to produce an environmental scan report. The report will define care communication and care coordination, discuss the impact of care communication and care coordination on health outcomes, define social determinants of health and discuss how they can affect care coordination, and highlight the opportunities and challenges associated with leveraging EHR-sourced data to Improve care communication and coordination. This report will be high-level and engaging, communicating the findings of the environmental scan to a broad audience who may or may not have healthcare expertise but who are Interested In understanding the relationship between clinical data and care coordination. If funded, the environ mental scan report will be followed by two reports of final recommendations that will outline how EHRs could better facilltate care communication and coordination and how EHRsourced measures can be used to Improve care communication and coordination, as well as possible EHR-sourced care communication and coordination measure conc;epts or specific areas of measurement within care communication and coordination. In late 2020, NQF solicited nominations for experts to seat on a Committee and begin the environmental scan, Including literature and measure reviews as well as expert Interviews. Rural Health Perspective Rural-Relevant Measures Core Set Low case-volume poses a measurement challenge for many healthcare providers In rural areas. Low population density, In combination with limited access to care, can reduce the number of patients eligible for inclusion In healthcare quality measures in Medicare public reporting and VBP programs. low case-volume affects the reliability and validity of measure scores, making it difficult to compare performance between providers or track changes In quality over time. CMS, through rulemaklng, sets minimum case requirements for Its quality reporting and VBP programs. As CMS continues to expand the use of outcome measures in its programs, low case-volume among rural providers would Increasingly limit CMS' ability to leverage outcome measures to encourage Improvement In quality of care among rural providers, and to provide meaningful Information to rural consumers to make informed decisions for their healthcare. In 2018, NQF convened a multlstakeholder Rural Health Workgroup to establish a Core Set of RuralRelevant Measures {Core Set) that identified performance measures that are high impact and meaningful to rural Americans, feasible for providers to report to Medicare programs, and resistant to low case-volume challenges. To further advance measurement science related to low case-volume, CMS tasked NQF to also convene a TEP that would provide input on promising statistical approaches that could be used to address the low case-volume challenge. Starting In fall 2019 through 2020, NQF worked to Identify a list of high-priority, rural-relevant measures susceptible to low case-volume, reporting challenges for future testing of the TEP's recommended statistical approaches. NQF reconvened the Rural Health Workgroup to conduct an environmental scan of rural-relevant quality measures included In Medicare quality reporting and VBP programs, as well as develop a priority measure list and discuss reporting challenges specific to measurement in rural areas. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.046</GPH> lotter on DSK11XQN23PROD with NOTICES1 ~ 48192 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices The Workgroup then recommended topic areas and measure attributes that would be used to Identify suitable candidates for the statistical testing. Through In-depth discussion, voting, and responding to public comments on a preliminary short list of candidate measures, the Workgroup selected 15 measures susceptible to low case-volume and recommended they be prioritized for future testing of statistical approaches to overcome this challenge. The list of prioritized measures reflects a mix of measure attributes (e.g., type, analysis level, and care setting) and topic areas relevant to rural populations, including patient experience, access to care, behavioral health, chronic obstructive pulmonary disease, healthcare-associated Infections, perinatal care, readmissions, transitions of care, and sepsis. If future testing to overcome low case-volume challenges proves successful, this measure list may represent a key source of rural-relevant measures that can be considered for use In measurement programs. The creation of this prioritized list is an important step towards achieving high quality and high-volume outcomes for all Americans, regardless of whether their area of residence Is rural or geographically remote. Impact of Telehealth on Rural Healthcare System Readiness and Health Outcomes Telehealth offers tremendous potential to transform the healthcare delivery system by overcoming geographic distance, enhancing access to care, and building efficiencies. The promise of telehealth has been particularly important In the wake of the COVID-19 pandemic, which has severely limited the ability of many Americans to see their healthcare providers in person. The COVID-19 pandemic has also brought the unique challenges faced by rural Americans Into focus. Compared to urban dwellers, rural residents may be hit harder by the pandemic because of the continuous weakening of rural healthcare infrastructure. Rural communities have long been plagued by a lack of resources, closing of rural hospitals and other healthcare facllltles, healthcare professional shortages, lack of transportation options, and limited avallablllty of medical specialists. The prevalence of chronic conditions among rural Americans could further exacerbate the Impact of the pandemic. Most US rural residents tend to be poorer, older, and sicker than non-rural residents, making the rural residents more vulnerable to infectious diseases than non-rural residents. Even for rural residents who are not infected, those with ambulatory care-sensitive chronic conditions-who normally depend on regular monitoring to keep their symptoms under control-may be confronted by even higher barriers to care during disaster events and other public emergencies. While telehealth may be an important part of the solution, there has been a lack of empirical evidence In the literature related to the experience of using telehealth to support surge capacity or strengthen system readiness in times of pandemics, natural disasters, mass violence, or other public emergencies. This moment provides an excellent opportunity to Identify measures or measure concepts that may be appropriate for assessing the potential Impact of telehealth on rural healthcare system readiness. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.047</GPH> lotter on DSK11XQN23PROD with NOTICES1 HHS has tasked NQF with developing a measurement framework linking quality of care provided by telehealth, system readiness, and rural health outcomes in a disaster. For this effort, NQF will build on foundational efforts In 2017, Creating a Framework to Support Measure Development for Telehealth. and a 2019 framework identifying key considerations for measuring and reporting the quality of Healthcare System Readiness. In late 2020, NQF assembled a new multlstakeholder Committee of experts who will lead efforts of project activities through 2021. Speclflcally, Committee members will explore what capabilities telehealth requires to save lives In rural areas during a national emergency, what health outcomes In a national emergency can be fairly attributed to quality of care delivered by Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48193 telehealth, and what other factors (e.g., Infrastructure, flnanclal, and type of emergency) should be accounted for• In assessing the impact of telehealth on health outcomes In a disaster. The Committee will need to be especially considerate of recent changes In telehealth technology, policy, and practice to ensure that the new measurement framework Is high quality and meets the needs and contours of the current telehealth environment. Oploids and Behavioral Health Opioid-related overdose deaths and morbidity have emerged as a complex and evolving challenge for the us healthcare system. The March 20, 2020 Morbidity and Mortallty Weekly Report confirmed that In 2.018, there were nearly 47,000 US deaths attributable to opioid use, both prescription and Illicit (WIison et al,, 202.0). Moreover, a large proportion of those deaths are tied to heroin that Is laced with Illegally manufactured synthetic and semi-synthetic oplolds •. While this represents a decrease from 2017 ln deaths lnvolVlng all oplolds by two percent, heroin by four percent, and prescription oplolds by 14 percent, death rates assoi::lated with synthetic opioids increased by 10 percent (Barry, 2018). Quality measures related to opioid use are a key component to holding care providers, payers, and policymakers accountable as direct purveyors or Indirect sponsors of the best possible care regarding pain management.and substance use dependence treatment and prevention. Under section 6093 of the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act (section 1890A(g) .of the Social Security Act), CMS funded NQF to convene a 28-member TEP composed of physicians, nurses, patients, pharmacists, and others with expertise In pain management and OUD to address opioid measurement challenges from 2019-2020. The TEP made a series of recommendations related to identifying and prioritizing gaps In quality measures that needed to be filled to reduce OUD and opioid overdose deaths without undermining effective pain management. In addition, the TEP made recommendations for appropriate opioid-related measures and measure concepts to be deployed In five federal quality and performance programs administered by CMS (National Quality Forum, 2020). The Opioid TEP recognized an emerging "fourth waveH of the opioid epidemic related to polysubstance use. Increasingly, lndlvlduals with OUD are more likely to use psychostlmulants such as amphetamines, use oplolds with other substances during the same use period, and suffer from concomitant psychiatric conditions, such as anxiety, depression, and suicidal Ideation (Snyder et at., 2019). In 63 percent of opioid overdose deaths, evidence of co-occurring prescription or illlclt drug use was also present (Gladden et al., 2019). Because of the clear connection between concomitant behavioral health {BH) conditions with OUD and the impact of polysubstance use on opioid mortality and morbidity, the TEP prioritized the Identification and development of measures that address comorbiditles of OUD with psychiatric conditions and substance use disorder (SUD). VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.048</GPH> lotter on DSK11XQN23PROD with NOTICES1 In late 2020, NQF convened a new Committee for Oplolds and Behavioral Health (OBH) to address the priority Identified by the Opioid TEP. The OBH Committee will conduct an environ mental scan of currently available, all-payer measures or measure concepts that address overdose and mortality resulting from polysubstance use Involving synthetic or semi-synthetic opiolds among Individuals with co-occurring behavioral health conditions. CMS has an Interest In all-payer measures to facilitate alignment across payers and programs, to promote focus on commonly held quality priorities, and to reduce provider burden associated with measure reporting. <;MS has also expressed an Interest In outcome measures, Including PRO·PMs, as well as digital measures that draw on low-burden data sources. The Committee wlll be especially cognizant of measures that address pertinent social 48194 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices determinants of health related to OUD. The Committee ls partlcularly Interested In measures or measure concepts related to non-medical levers or non-medical partnerships. Measure gaps identified will also be discussed and prioritized. In 2021, the Committee plans to develop a measurement framework based on the environmental scan. common Formats for Patient Safety1 The Common Formats for Patient Safety is a project that began In 2013 and ls supported by AHRQ to obtain comments from stakeholders about the Common Formats authorized by the Patient Safety and Quallty Improvement Act of 2005 (Patient Safety Act) (Health and Human Services, Office for Clvll Rights, 2008) that authorizes AHRQ to designate Patient Safety Organizations (PSOs) that work with providers. To support PSOs in reporting data in a standard way, AHRQ created "Common Formats"-the common definitions and reporting formats-that standardize the method for healthcare providers and PSOs to collect and exchange Information for any patient safety event, The objectives of the Common Formats tools are to standardize patient safety event data collection, permit aggregation of collected data for pattern analysis, and learn about trends In patient safety concerns. AHRQ first released Common Formats in 2008 to support event reporting in hospitals and has since developed common Formats for event reporting within nursing homes and community pharmacies, as well as Common Formats for hospital survelllance. The Co.mmon Formats for event reporting apply to all patient safety concerns, includlng Incidents, near misses or close calls, and unsafe conditions. NQF, on behalf of AHRQ, coordinates a process to obtain comments from stakeholders about the Common Formats and facilitates feedback on those comments via an NQF-convened Expert Panel. In 2020, NQF continued to collect comments on all elements {Including, but not limited to, device or medlcal/surglcal supply, falls, medication or other substance, perinatal, surgery, and pressure Injury) of the Common Formats, Including the most recent release, Hospital Common Formats Version 0.3 Beta. The public has an opportunity to com.ment on all elements of the Common Formats modules using commenting tools developed and maintained by NQF. In 2020, NQF also upgraded the technology platform supporting the Common Formats commenting tool and filled several vacancies on the Expert Panel. Person-Centered Planning and Practice Person-centered planning Is a facllltated, lndlvldual-directed, positive approach to the planning and coordination of a person's services and supports based on fndlvldual aspirations, needs, preferences, and values. The goal of person-centered planning Is to create a plan that wlll optimize the person's selfdefined quallty of life, choice, control, and self-determination through meaningful exploration and discovery of unique preferences, needs, and wants In areas Including, but not limited to, health and well-being, relationships, safety, communication, residence, technology, community, resources, and assistance. From 2019-2020, NQF convened a multlstakeholderCommlttee to address Person-Centered Planning {PCP) ln long-term services and supports {LTSS) systems. Committee members represented a variety of stakeholders, Including self-advocates, caregivers, purchasers, providers, health professionals, health plans, suppliers, and experts in community and public health and healthcare quality. The committee Included experts In PCP, family-centered care, shared decision making, self-advocacy, consumer VerDate Sep<11>2014 This project Is not funded under section 1890/1890A of the Social SeturitV Act. 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.049</GPH> lotter on DSK11XQN23PROD with NOTICES1 1 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48195 engagement,. home, and commun1ty0 based services (HCBS), faclllty-basecl. care, community Inclusion, and Medicaid. The dlverslty of people who use. LTSS required representatlon of self-advocates from the mental health, nursing home, dementia, and disabifity communities. The Committee reflected the diversity of experience and Insight; as well asthe historical experience of being marginalized and underserved. Its diverse membership underscores the. need to find slmllarttles and maXlmlze inclusiveness to move the field forward. Through a consensus-building process, stakeholders representing a variety of diverse perspectives met throughout the project to refine the current definition for PCP;. develop a set ofcore competencies for pertormlng PCP facilitation; make recommendations to HHS on.system characteristics that support PCP; conduct a scan that includes historical development of PCP in LTSS systems; develop a conceptual framework for PCP measurement; and create a research agenda for future PCP research •. throughout their dellbera1:1ons, the Committee ec>nstdered the focusc>n the person and the context of their life to be at the center of the i>CJ> process, The plan that emerged and. Its Implementation Is Influenced by the coinpetenctes exhibited bfthe facilitator of the. plahni~.the existing characteristics of thapersqn's hll!althcare.systemenvtronment; and the quality rneasufll!ment and tmpre>vement efforts dlrectlYasSoclated wtth.eacl't step ofthe PCP. The final recommendations ofthe PCP committee afll! provided within a summaryN!J)Ort. Matema1Morb1dityand P./lortality Maternal morbidity and mortality have been identified as primaryindicators of women's health and quality of healthcare globally. The Healthy People 2020targetgoal for the US maternal mortality rate is 11.4 maternaldll!aths (per 100,000 live bfrths), but as of20l8 the US rate i517.4 maternal deaths (per 100,000 live births} (Centersfor Disease control and PreVentlon, 2020c). Thls rate rs much higher than other high•inc;ome countries,with more than 700 women dying annually from pregnancy-related causes. the leading causes ofoverall maternal mortality can be attributed to Increased rates of CVD ,. hemorrhage, and Infection (centers for Disease control and Prevention, 202oa). women with poor maternal outcomes are at increased risk for recurrence in their next pfl\!gnancyand are at increased risk of chronicJllness later In life; While the postpartum period presents an opportunity to intervene to Improve this trajectory; many women.still face barriers, such as cost,.transp0rtat1on, lack of provider avallablllty, loss of lnsurance, Chlfdcare, psychological distress, challenges communicating with a provider, and health literacy. In fall 2019, NQ.f convened a 35-person multlstakehofder Maternal Morbidity and Mortality COtnmlttee to provide input and guidance on the identification oftwo measurement frameworks: (1) measure concepts and (2) actionable measurementapproachesaddresstngfacets of maternal morbidity and mortality. This project includes the development ofan environmental scan, two trutasurement frameworks addressfng maternal morbldity and mortality separately, a recommendation for an. actionable maternal mortality measure concept, and recommendations for actlonal.measurement approaches for morbidity and mortality. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.050</GPH> lotter on DSK11XQN23PROD with NOTICES1 During 2020, the Committee was convened through seven web meetings to discuss the content of the environmental scan, measurement frameworks, and l'nOrtality measure concept(s). The environmental scan fOcused on prevalence, incidence, risk faetors{mei:lical and non°medical), measure concepts, fully developed measures, measures In use, proc;esses for maternal care delivery; maternal health outcomes (e.g., postpartum readmissions, infections, inJurleS; and other pregnancy compncatlons In addition to 48196 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices mortality) and other factors/areas Influencing outcomes, Including health disparities. It also highllghted Innovations in measurement methodologies, llmltations or gaps In measurement and considerations regarding measurement data sources. As presented in the environmental scan, the Committee discussed the importance of Influencing factors related to maternal morbidity and mortality, Including both clinlcal and nonclinical components across the continuum of care. These influencing factors were further defined by individual levels (e.g., age, education, knowledge, beliefs, and behaviors); societaVcommunity factors {e.g., social network, built environment, and housing); hospital factors (e.g., Implicit bias, cultural competence, and communication); and system-level factors (e.g., access, structural racism, and policy). These factors are Interrelated and contributors to each other; they emphasize the importance of the pregnancy and childbirth experience along the continuum of a woman's life. This notion underscores the need to broaden the viewpoint to include a comprehensive assessment of medical and nonmedlcal risk factors to better understand the larger context of influencers and contributors for adverse outcomes beyond traditional hospital risk factors. The environmental scan highlighted several nonclinical Influencing factors, which Included healthcare disparities, race and racism, discrimination, residential segregation, impllclt bias, language barriers In healthcare, health literacy, rural communities, and other social determinants of health. The full copy of the environmental scan also expands upon specific contributors to severe maternal morbidity and matemal mortality along with Innovations In measure methodologies and a 11st of existing measures. The Committee continues to discuss the two separate measurement frameworks for maternal morbidity and mortality as well as Identify an actlonal mortality measure concept. The final recommendations report will Include these frameworks as well as short- and long-term Innovative actionable approaches to improve matemal morbidity and mortality measurement across various healthcare settings and detail how to use the measurement to Improve maternal health outcomes. The final recommendations report is expected in August 2021. Measure Feedback Loop Measure feedback Is essential to the quality improvement enterprise. Feedback on quality measures provides an important opportunity to understand the extent to which data forthe measures is being captured without undue burden; how, where, and who is using the measures; what, if any, unintended consequences arise from using the measures after they receive NQF-endorsement on providers, payers, consumers, caregivers, measured populations, and others; and, ultimately, whether measures are having their intended effect on improving the quality of care and health outcomes for individuals and populations. The NQF measure feedback loop refers to the process of providing feedback from those who use measures to measure developers and Standing Committee members who may have recommended that the measure receive or maintain NQF-endorsement or be selected for use in a federal quality program through MAP. To close the loop, responses to the feedback should be shared back with those who submit feedback. Gathering meaningful, timely, comprehensive, and actionable feedback on measures after they are implemented also helps NQF and quality measurement stakeholders to engage in continuous quality Improvement of the quality improvement enterprise. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.051</GPH> lotter on DSK11XQN23PROD with NOTICES1 For the Measure Feedback Loop project, NQF convened a multlstakeholder Committee to understand NQF Standing Committee needs for measure feedback and to ellclt ideas for innovative, efficient, and effective approaches to integrate measure feedback into the measure endorsement process and maintenance of endorsed measures. This multistep effort was aimed at Improving NQF's measure Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48197 feedback loop by Identifying a set of strategies that can be plloted to Improve the ways In which NQF solicits, collects, facilitates, and shares measure feedback among stakeholders within NO.F's endorsement and maintenance processes. In June 2020, NQF dellvered the final report for the project that focused on a proposal Implementation plan to pilot and evaluate strategies to fmprove the measure feedback loop that allgn with the Committee's goals for the measure feedback loop pilot to minimize burden for those providing feedback; ensure relevant stakeholders know how to provide measure feedback to NQF; ensure NO.F Standing Committees receive meaningful and adequate information to apply the feedback to the relevant measure evaluation criteria and make informed recommendations for endorsement; ensure developers receive timely, meaningful, and actionable measure feedback; ensure those who provide feedback hear back about how feedback was or was not addressed; and define a standard pathway for generating and collecting measure feedback. The proposed plan for the measure feedback loop pilot implementation consists of three steps: (1) generate meaningful and actionable feedback from measure users; (2) standardize and streamllne the NQF Measure Feedback Tool and measure feedback process; and (3) support stakeholders to apply the measure feedback collected through prior steps. These steps include strategies and tactics that the Committee rated as having high-potential benefit while being at low- to medium-resource Intensity to support the feasibility of Implementing successful strategies beyond the pilot. Continuous efforts to improve the measure feedback loop is vital to the success of the quality improvement enterprise and requires the buy-In and participation of key stakeholders from the healthcare community, Including measure users, measure developers, and NQF Standing Committee members. Patient-Reported Outcomes: Best Practices on Selection and Data Collection Prior work by NQF created structured recommendations around patient-reported outcomes (PROs), patient-reported outcome measures (PROMs), and patient reported outcome performance measures (PRO-PMs) (National Quality Forum, 2012b). While the differences between these are subtle (e.g., in the context of knee replacement, post-surgical symptoms, such as pain, are considered PROs), a patient-reported survey of the knee Injury and osteoarthritis outcome Is considered a PROM, and the provider performance managing the post-surgical knee pain Is an example of a PRO·PM. Unfortunately, both the widespread use and adoption of PROs and PROMS have faced barriers, as have the development, endorsement,.and Implementation of PRO-PMS (Philpot et al., 2018). Currently, NQF's measure endorsement portfolio Includes seven PRO·PM measures. These barriers may stem from clinician and patient concerns about upstream factors of PRO-PM development, namely the value and choices of PROs and the selection and implementation of PROMs. Limited relevance of some PROs to patient goals, clinicians' concerns about the limited value. of some PROs to care planning, a lack of guidance for cllnlclans on how to Interpret PRO data, and burden of PROM Implementation and incompatibility with workflow have all inhibited efforts to develop and expand the use of PRO-PMs in Informing quality Improvement. To Increase broad-based acceptance of PRO~PMs, It would be Important to addressthese upstream hurdles related to PROs and PROMs. An environmental scan was published In December 2019, providing a current assessment of PRO use Within healthcare. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.052</GPH> lotter on DSK11XQN23PROD with NOTICES1 The flnal technlcal report. released In September 2020, built on the environmental scan by providing guidance from the TEP that clinicians and organizations can use in addressing barriers that affect.the selection and implementation of PROs and PROMs •. The final report reviews commonly used 48198 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices PRO categories and discusses best practices for PRO selection In cllnlcal care. Patient, family member, and caregiver Involvement are critical components of PRO selection to ensure the Information ls meaningful, and thts perspective should accompany a multlstakeholder selection process that also Includes cllnlclans, researchers, and other experts. key takeaways lndude the Importance of ldentlfying the overarching cllntcal goals that PROs shculd meet and the Importance of keeping actlonablllty and teaslb!Uty In mind throughout the selection proc85$, The final report also discusses how to select the cor'l'eet PROM for an organization In order to .collect data and generate u.sable information to help Inform patient care. The multistakeholder selection team should understand thatPROMs exist on a continuum of speelflctty and range from disease• agnostlt to dlsease•speclflc, each With Its unique set of advantages. Patients bring rmportant perspectives to questions arounc:I burden (e.g., how long it takes.to complete each PROM)r modes {e.g., whether a PROMIS self~ac:lmlnlstered or completed via Interview)! and methods {e.g., whether a PROM Is completed via paper; email, or patient portal). Involvement.by providers and other experts ls also Critical when selecting PROMs, as these stakeholders can inform the perceived value. of different PROMs in improving care. The final report reviews and expands upon the attributes of PROMs that were discussed In past literature and that should be considered during the selection process. Five best practices for PROM selection are Introduced, and an attribute grid Is presented as a tool to ald In comparing and selecting them. The final technical report explores best.and prorrilslng practices related to the implementation of PRO Ms. Buy-in from patients, clinicians, leadership, and other key stakeholders is arguably the most critical aspect of Implementation, and the report offers guidance on securing buy-In. The burden .of data collection affects both clinical staff and patients, and recommendations are proVlded to minimize this. burden. Workflow implementation is addressed, including the opportunities to delegate. tasks around the collection, interpretation, and communication of outcomes data. appropriately across clinical and support staff. C1Iniciansn:1ust be able to accurately Interpret scores and communicate effectively With patients about what the scores mean, and recommendations are Included to lmprove interpretation and cornmunlcation. Promising practices are explored around the integration ofPROMswlth EHRs, as are the tmpllcatlons of using return-on-investment and patient~ and physlclan-lncentlves asa prlmaryway to measure the cost, value, and benefit of PROMs. Using three cllnlcal scenarios (bums and trauma, heart failure, and joint replacement) as ex.itnples, the pi:oJect ex.imined key elements of PROMS and assessed use cases for different peopfeJnvolved In the selection process. Building a Roadmap From Patient-Reported OUtcome Measures to Patient-Reported OUtcome Performance Measures VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.053</GPH> lotter on DSK11XQN23PROD with NOTICES1 In the foreseeable future, measure developers will create dlgital PRO-PMs that are based on high quality PRO Ms; EHR systems will not only collectllata for those PRO~PMs, but will also calculate and submit aggregate scores for regulatory and reimbursement. purposes. For this.to occur, measure developers need step-by-step guidance to help Identify attributes Of high quality i>ROMs and create digital PRO-PMs thahre based on those PROMs. NQf will .create this guidance, or roadmap, by convening a TEP that consists of measure developers; health rr experts; clinicians and representatives of professional societies; professionals Tnvolvell In payment, relmbul"Sement; and purchasing; and patients. This work will be viewed through the lens l>f chronic pain and functional llmltatlons, two areas with deep knowledge of patient-reported measures. Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48199 In late 2020, NQF solicited nominations to convene a TEP. This panel of experts will be finalized In early 2021 and will be charged with developing an environmental scan report that wlll review literature related to high quality PROMs and how they can affect the development of PRO-PMs, speclflcally electronic or digital PRO-PMs. Because of the novel nature of this Initiative, NQF staff have also been exploring other resources, such as PRO-PMs that have undergone the NQF endorsement process (either successfully or unsuccessfully), bodies that review and recommend PROMs, and any PROMs and/or PRO-PMs that are used by CMS VBP Programs or APMs. NQF alms to present Its lnltlal environ mental scan findings at the first TEP meeting In January 2021. Ele.ctronic Health Record Data Quality one of the promises of EHRs Is that they enable automated cllnlcal quality measure reporting. EHR systems are prlmarily designed to support patient care and billing, not necessarily capture additional data to support quality measurement (Centers for Medicare & Medicaid Services, 2019b). However, since EHR data are routinely collected for patient care that can be used for cllnlcal quality measures, they can be reused to reduce provider burden associated with public reporting and VBP programs {Eisenberg et al., 2013). Despite high adoption rates In multiple care settings, the promises of EH Rs have not yet been fully reallzed because of conslderable variation In data quality. NQF defines electronic clinical quallty measures {eCQMs) as measures that are specified using the Industry accepted eCQM technical specifications, which include, but are not limited to, health quality measure format (HQMF)., the Quality Data Model {QOM), Clinical Quality Language (CQL), and value sets vetted through the National Library of Medicine's Value Set Authority Center (VSAC) {National Quality Forum, 2012a). Using EHRs as a source of data, eCQMs were designed to enable automated reporting of measures using structured data. With the use of structured data, eCQMs have the potential to provide timely and accurate information pertinent to clinical decision support and. facilitate timely and regular monitoring of service utlll:tatlon and health outcomes {Balley et al., 2014). Currently, NQF has endorsed nearly 540 healthcare performance measures with only 34 of these being eCQMs. Although the number of endorsed eCQMs is low, several measures in NQF's portfolio are quality measures that rely on data that come from an EHR, which NQF refers to as EHR-sourced measures. NQF has Identified the ablllty of EHR systems to connect and exchange data as an Important aspect of quallty healthcare. However, eCQMs.and EHR data are not enough to enable automated quality measurement. To better understand the potential of improving quality measurement with the use of EHR data for clinical quality measures, it Is Important to examine the current state of EHR data quality. In 2020, NQF continued the implementation of an 18-month project that was initiated in 2019 to Identify the causes, nature, and extent of EHR data quallty Issues, particularly as they relate to measure development, endorsement,.and Implementation. This multlstep effort was aimed at Identifying a set of strategies for addressing issues hindering EHR data quality and focused on how well EHR data can be used to support automated clinical quallty measurement. To achieve this, NQF convened a 21-member multlstakeholder TEP over a series of web meetings to guide and provide Input on the work. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.054</GPH> lotter on DSK11XQN23PROD with NOTICES1 Addltlonally, NQF completed an envlronm.ental scan that was delivered to CMS In May .2020 and Identified currently avallable Information on EHR data quallty Issues, current efforts to address these Issues, and key stakeholders' perspectives and Input based on their experiences. The current state assessment from the environmental scan set the foundation for the development of a final report that will be delivered to CMS In December 2020, which offers recommendations on how to advance EHR data In ways that better support the development, endorsement, and lmplementatlon of eCQMs. An 48200 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices overarchlng Issue of EHR data quality lden~lfled by the TEP Is the challenge of ellcltlng multfple. stakeholders (e.g., vendors. and providers) to participate with measure developers early and throughout the development life cycle In a way that balances the cost of participation with the downstream benefit of reduclngworkflow and Implementation costs once the tested measure ls In each program. Although the final report focuses on opportunities for HHS, CMS. and NQF, additional work In this area does not only lie with these stakeholder groups. It Is recommended that future work should focus on oppcrtunlties for other stakeholders who can have an Impact 01'1 EHR data quality Issues beyond HHS, CMS, and NQF; Untrtthen, NQF will share the r:ecomrnendatlons in the flnal report With HHS, CMS, and other external stakeholders tor consideration and pctential implementation. Reducing Diagnostic Error The delivery of high quality healthcare is predicated upcn an accurate and timely diagnosis. Diagnostic errors; which are defined as the failure to establish or communicate an accurate and timely assessment of a patient's health problem, contrlbOte to an estimated 40,000-80,000deaths,each.year{Leapeet al., 2002}.Approximately 12 million Americans suffer a diagnostic error each year, and.the National Academies of science, Engineering, and Medicine (NASEM) committee on D1agnosttc Error In Health Care suggested that most people wlll experience at least one diagnostic error in their lifetime {Singh et al., 2014). In 2017, l\l(lf convened a multlstakehoider Expert committee to develop a conceptual framework fer measuring diagnostic quality and safety and to identify priorities for future measure development, The 2017 Measurement Framework included three domains: (1) Patients,FamUies, Caregivers; (l) Diagnostic Process and Outcomes; and (3) Organ12atron and Polley Qpportunltles. To further advance patient safety and reduce diagnostic error, NQF convened a new multlstakeholder Committee: In 2015t to. revisit and build on the prevTous Committee's work. The lmprovlng Diagnostic. Quality & Safety/Reducfng Diagnostic Error: Measurement tcnslderations Committee first reviewed the Diagnostic Process and Outcomes.domain of the 2011 Measurement Framework to ldentlfy any needed updates. The Committee also Identified high-priority measures, measure concepts, current performance measures, and areas for future measure develcpment that have emerged since the initial development of the 2017 Measurement Framework. Informed by these activities and over a series of web meetlngs-flve of which occurred ln 2020-the Committee developed practical guidance, including specific use cases to demonstrate how the framework can be operationalized In practice, as well as detailed tecommendatlons for measurli'ig and reducing dlagnostlc error, VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.055</GPH> lotter on DSK11XQN23PROD with NOTICES1 The tcmmlttee designed four use cases to support the practical appllcatlon of the Diagnostic Process and Outcomes domain of the 2017 Measurement Framework. The use cases were developed by the Committee asan opportunity to Identify comprehensive resolutions to specific types of diagnostic errors. The tour use.case topics selected {I.e., missed subtle cllnlcal findings, tommunlcation failures, information overload, arid. dismissed patients) reflect high-priority problems and examples of diagnostic errors that cause patient harm. Each use case describes a type of diagnostic error; Its causal faetors, key stakeholders who can help overcome and prevent the error, arid globai and granurar sOlutions to the error. The solutions within the use cases reflect opportunities for stakeholders to reduce diagnostic errors In the subdomalns of the Diagnostic Process and Outcomes domain of the 2017 Measurement Framework, allowing. for stakeholders to drive Improvement In multiple areas, Including Information gathering and documentation, information Integration, Information lnterpretatlon,. diagnostic efftclency, Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48201 diagnostic accuracy, and follow-up. Use cases also include snapshots of case exemplars to demonstrate how the specific solutions can be implemented In practice. The case exemplars range across settings and populations. Each use case concludes with a description of the impact of the Identified solutions on patient safety, as well as a section on measurement approaches and measure concepts. The Committee also identified a series of comprehensive, broad-scope, actionable, and specific recommendations for applying the Diagnostic Process and Outcomes domain of the 2017 Measurement Framework and for measuring and reducing diagnostic error. Recommendations for applying the Diagnostic Process and Outcomes domain highlight Implementing quality Improvement activities to Identify and reduce errors to prevent them from occurring, Including specific recommendations related to engaging patients, educating cllniclans, developing, and deploying clinical protocols, leveraging technology, supporting a culture of teamwork, and improving Information sharing. Each recommendation for applying the 2017 Measurement Framework aligns with a specific recommendation for measuring and reducing diagnostic error. These measurement-focused recommendations are centered around using patient-reported measures; assessing, providing, and obtaining feedback on cllnlclan diagnostic performance and adherence to diagnostic protocols; evaluating the Impact of technology and leveraging technology to reduce errors; measuring communication and teamwork; assessing the appropriate use of laboratory testing and radiology; and measuring the total cost, time, and Impacts of diagnostic odysseys. Each recommendation has related actions for diverse stakeholders to measure and evaluate current processes and outcomes, Including the Identification of prioritized measure concepts. In October 2020, NQF delivered the final report for this project, which Includes the Committee's recommendations for the practical application of the Diagnostic Process and Outcomes domain of the 2017 Diagnostic Quality and Safety Measurement Framework, measuring and reducing diagnostic error, and measuring and Improving patient safety. The final report Incorporates feedback received from the public during the 30-day public commenting period that occurred from July to August 2020. Diverse stakeholders (e.g., healthcare organizations, cllnlclans, patients, payers, measure developers, EHR vendors, policymakers, and others) can use the practical guidance and recommendations In the report to reduce diagnostic errors. Stakeholders can use existing measures and measurement concepts, as well as the future measurement approaches, to identify specific opportunities for reducing diagnostic error and improving patient safety. The Implementation strategies and solutions within the report can subsequently be used to drive Improvement in diagnostic processes and outcomes. Organizations and stakeholders can also use existing measures, measure concepts, and future measurement approaches to measure the effectiveness of the Interventions and solutions. Diverse stakeholders can Implement the broad-scope, comprehensive recommendations Included In the report to applythe 2017 Measurement Framework, and to measure and reduce diagnostic error, ultimately Improving patient safety. VIII. Conclusion VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.056</GPH> lotter on DSK11XQN23PROD with NOTICES1 Now more than ever, national health priorities continue to highlight the need for Improvement of quallty measurement. Promoting effective communication, prevention, and treatment of chronic disease, working with communities to promote best practices of healthy llvlng, and making care affordable are all still at the forefront when drMng to deliver better health and healthcare outcomes. 48202 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices The COVID-19 pandemic, a national priority, underscored the immense need to work collaboratively to raise healthcare quaf(ty to the next level through measurable health Improvements. NQF received funding for a series of projects that would help to tackle some of the challenges highlighted as a result of the pandemic•.These projects focused on addressing the opioid-related outcome, attribution-critical Illness and Injury, arid Identifying best practices fordevelopfng and testing risk adjustment models. CMS anti NQF together have recognized the neec:i to further address these topic areas andwlll continue to work together to address some Imrnedtate challenges to pave the way to dose these gal) areas. This year, NQF sought to maintain a coordhiated effort across public and private payers by facilitating alignment through the development and adoption of core measure sets; as well as expanding the cllnlcal topics during 1020 to fnclude behavfbral health and neurology, .The increased reliance upon performance measures has led to expanS1on.1n the number of measures being used and an Increase In burden -0n providers collecting the data, confusion among consumers and purchasers seeing conflicting measure results, and operational difficulties arnong payers. NQ.F~s Measure Applfcatlons Partnership (MAl>)ls composed ofstakeholders from across the healthcare system, including patients; clinicians; providers, purchasers,and payers, who continue to recommend measures for use in federal programs and provide strategic: guidance. Through Its eight.years of prerulemaklng reviews, MAP has aimed to 1.ower costs while Improving.quality, promotethe use of meaningful measures, reduce the burden of measurement by promoting alignment and avoiding unnecessary data colfectlcm, and empower patlents to become actlve consumers by ensuring they have the Information necessary to supportthelr healthcare decisions. MAP'S work that concluded In. 2020 Included a review of 18 performance measures under consideration for use In nine HHS quality reporting and vatue•based payment programs coverfng cl!nlcian, hospital, and post~acute/long-tenn care settings. NQF's work in evolving the science of performance measurement has also expanded over the years, arid recent projects focus on challenges that stand In the w.ay ofachfevlng high value outcome and cost measures, as well as brfogll'ig new. kinds of providers Into accountability programs, NQf continued to bring together exl)erts through rnultlstakeholder committees to identifyevidencebased performance measures. NQF's work to review and endorse perfonnance measures provides stakeholders with valuable lnformatlon to Improve care delivery and transform the healthcare system. NQF-endorsed measures enable healthcare providers to understand if they are providing high quality care and where Improvement efforts remain. NQF maintains a portfolio of evidence-based measures that address a wide range of cllnlcal and crqss"-CL!ttlng topic areas. In 2020, NQF endorsed 84 measures across~ cycles for each of the 14 topic areas. In addition, NQF's Standing committees surfaced Important measurementgaps ln areas such as behavioral health and substance. use arid perinatal and women's health. NQF remains commlttedto ensurlngthe endorsement process ls transparent and objective through thelwo-cycle review that occurs every year. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.057</GPH> lotter on DSK11XQN23PROD with NOTICES1 NQF alSt> undertook several project$ In 2020 to create strategic approaches; or frameworks, to measure quality In areas.crltlcal to lmprovlog health and healthcare. These projects spanned across several toPicS; including maternal health, person-centered planning, improving EH~-sourced rn~ures, rural health, c:ros1ng the measure feedback !()Op, PROs, common formats for-patient safety, and reducing diagnostic: error, Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48203 VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.058</GPH> lotter on DSK11XQN23PROD with NOTICES1 In 2021,. NQF looks forward to partnering with CMS to address other Issues that may hinder collective efforts to address measurement science challenges and furtherthe efforts In dellvery ofcare. 48204 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices IX. References Abbaszade, A.,.Assarroudl, A., Armat, M. R., Stewart, J. J,, Rakhshanl, M. H., Sefidi, N., & Sahebkar, M. (2020). Evaluatlon of the Impact ofHandoff Based on the SBAR Technique on Quallty of Nursing Care;Jourmil of Nursing Care Quality. https:/ldol.org/10.1097/NCQ..0000000000000498 Agency for i-lealthcare-Research and Q.uallty. {2014). Chapter 3. Care Coordination Measurement Framework.•http:f/www.ahrq.gov/ncepcr/care/coordination/atlas/chapter3.html Agency for i-lealthcare Research and Quality; (2018). Priorities ofthe National Quollty Strt1tegy. htt.ps://www.ahrq.gov/research/flndlngs/nhqrdr/nhqdr1S/prlorltles.html American Cancer Society. {2020). Cancer Facts & Figures 2020. 16; Auerbach, A. D,, Krlpalanl, s., Vasllevskis, E. E,, Sehgal, N., lindenauer, P. IC., Metlay, J. P,, Fletcher, G., Ruhnke,'6. W;, Flanders; S.A., Kim, c., Wllllams, M. v., Thomas, L, Giang, v., Herzig, s. J., Patel, K., Boscardln, W. J., Robinson, E. J., & Schnipper, J. l. {2016). Preventablllty and Causes pf Readmlsslons in a National Cohort of General Medicine Patients. JAMA lntemaf Medicine, 176(4), 484--493; https:/ldoi.org/l0.1001/jamalnternmed.2015.7863 Balley, L. C., Mistry, IC. B., Tinoco, A., Earls; M., Ralllns, M;. C;, Hanley, K,, Christensen, K., Jones, M., & Woods, D~ {2014). Addressing electronic cllnlcal Information In the construction of quality measures. Academic Pediatric$, 14(5 Suppl}, S82-89. https:/ldoi.org/10.1016/j.acap.2014.06;006 Barry; c. L. (2018); Fentanyl and the evotvrng oplold epidemic: What.strategies sttould polfcy makers consider? Psychiatric: Services {Woshington; D.C.}, 69(1), 100-103. htt.ps:/ldol,org/10.1176/appl.ps.201700235 Benjamin, E. J., Muntner, P., & Alonso, A. (2019). Heart Disease and Stroke StatlstlCS:-20l9 Update: A Report From.the Amerfcan Heart Association; American Heart Assoclatlon. https;//dol.org/lD.1161/CIR.0000000000000659 Bernheim, S. M., Parzynski; C. S., Horwitz~ L,. Un; Z.; Araas, M. J., Ross, J. S., Drye, E. E;, Suter, L G., Normand, S, 0 L. T., & Krumholz, H. M. (2016). Accounting For Patients' Socioeconomic Status Does Not Change Hospital Readmission· Rates. Health.A[falrs {Project Hope), 35(8), 1451...:1410. htt.ps://dol.org/l0.1377/hlthaff.2015.0394 Birnbaum, H., Pike, c., Kaufman, R., Maynchenko, M., Kldole;zf,Y~, & Clfaldl, M; {2010). societal cost of rheumatoid arthritis patients In the US, CurrentMedlcal Research and Opinion, 26{1}, 77-90. htt.ps:f/dol,org/10.1185/03007990903422307 Blum Alexander B., Egorova Natalia N., Sosunov Eugene A., Gelijns Annetine c., DuPree Erin, Moskowitz Alan J., Federman Alex I>., Aschelm Deborah D,; & Keyhanl Salomeh•. {2014). Impact of Socioeconomic Status Measures on Hospftal Profiling .In New York City. Circulation: Cardiovascular Quality and Outcomes, 7{3), 391-397. https://doi.org/10.1161/CIRCOUTCOMES.113.000520 Bose, J., Hedden, S. L.,. Uparl, ·R. N., & Park•lee, E. {2017). Key Substance Use and Mental Health lndlcotorsln the United States: Resu/ts from the. 2017 National survey on Drug Use and Health. ll.4. Carr, B. G;, Conway, P. H,, Meisel, z. F., Steiner, C. A., & Clancy, C. (2010}. Defining the emergency care sensitive condition: A health policy research agenda In emergency medicine. Annals of Emergency Medicine, 56(1), 49-S1, https://dol.org/10.1016/}.annemergmed.2009.12.013 Centers for Disease Control and Prevention. (2017). National Diabetes Statistics Re~ 2011; 20. Centers for Disease Control and Prevention. {iOloa, January 31). severe Matema/Motbldlty tn tire United States. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.059</GPH> lotter on DSK11XQN23PROD with NOTICES1 htt.ps://www.cdc:gov/reproductlvehealth/maternallntanthealth/severematernalmorbldlty;html. Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48205 Centers for Disease Control and Prevention. (2020b, September9). Stroke Facts. https://www.cdc.gov/stroke/facts.htm Centers for Disease Control and Prevention, (2020c, November 9). NVSS- Maternal Mortality-Homepage. htt.ps://www.cdc.gov/nchs/matemal-mortalfty/lndex.htm Centers for Medicart'l & Medicaid Services. {2019a). Medicare Benefiaary.Charocteristlcs. htt.ps:/{www.cms;gov/Research•Statlstlcs-Data-and-Systems/Statlstlcs-Trends-and-Reports/ChronlcCondltlOils/Medrcare_Beneflclary_Chatacteristlcs Centers for Medicare & Medicaid Services. (2019b, March 4). Medicare and Nledfctild Programs; Patient Protect/rm andAffr,rdobte Care Act; Interoperability and Patient Access tot Medicare Advantage Organizotlon and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entitles, Issuers ofQuall/fed H.ealth Plans In the Federally-Facilitated &chQnges and Health Care Providers. Federal Register. htt.ps://wwwJederalreg!ster.gov/documents/2019/03/04/2019-02200/medlcare-and-medltalcfprograms-patlent•protection-and-affordablec.care-act-lnteroperablllty•and eentersfor Medicare & Medicaid services. (2020). Preliminary Medicare COVTIJ-19 Data snapshot. https:/{www;cms;gov/flles/doc;ument/l'l'ledlcarec.covfd-19-data-snapshot-fact-sheet.pdf Chatterjee, P., &Werner, R. M. (2019). TM hospital readmlsSlon reduction program and soclal risk; Healtli Services Reseat:c;h, 54(2), 324-326. https:/ldoi.org/10.1111/1475-6n3.13131 Collfns; A. J., Foley, It N;, Chavers, B., GIibertson, D., Hei"log, C., lshanl, A., &Johansen, K. (2014). US RentJI Dato System 2013 Annuo1Dato lteport. 18, Eggleston, E. M~,& Finkelstein, J. A. (2014).Findingthe Role of Health Care in Populatlon Health.JAMA, 311(8), 797-798. htt.ps://do!.org/10.1001/jama:2014.163 Eisenberg; F.; Lasome, C., Advanl,A., Martins~ R., Cralg.: P.A., & Sprenger; S. (2013). AStudy Of The Impact Of Meaningful use Cllnlc:al Quality Measures. Amertcan Hospital Association. Frampton, S. B., Guastello, S., Hoy, L,, Nayfor; M., Sherldan,:S., & Johnston-Fleece, and M, (2017}. Harnessing Evidence and Experience to Change CUiture: A Guldlng Framework for Patient and Family EngagedCare.NAM.Perspectlves. https://dol.org/10.3141.8/201701f Franks, P,, & Fiscella, K. (2002). Effect of patient socioeconomic status on physician profiles for prevention, dlseasemanagement, and diagnostic.testing costs. Medical Care, 40(8), 717-724. https:f/doi.org/10,1097/0000565M00208000-00011 Gladden, R. M., O'Donnell,.J., Mattson, c. L., & Seth, P. (2019). Changes In Opioid-Involved Overdose Deaths by Opioid Type and Presence of Benzodlazeplnes, Cocaine, and Methamphetamlne-25 States, July-December 2017 to January-June 20111. MMWR; Morbidity Qlld Mortality Weekly Report, 68. https://dol.org/10.15585/mmwr.mm6834a2 Hastings, S. N., Oddone, E, Z., Fillenbaum, G., Sloane, R. J., & Schmader, K. E. (2008}. Frequency: and predictors of adverse health outcomes In older Medicare benefltlarfes discharged from the emergency department. Medical Care,46{8), n1..:.n1. https://dol,org/10.1097/MLR.Ob013e318179la2d Health and Human Services, Office for CM! Rlghts. {2008; May7). Pattentsafety and Quality Improvement Actof2005 Statute andRule [Text]. HHS,Gov, https://www.hhs.gov/hlpaa/for• professionals/patient-safety/statute-and-rule/ VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00092 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.060</GPH> lotter on DSK11XQN23PROD with NOTICES1 Health care Payment Learning and Action Network. (2016). Acceierotlng and Aligning Population-Based Payment Models: Patient Attribution. The MITRE Corporation. 48206 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Heron, M. (2016). Deaths: LE!ading Causes for 2014. Natl Vital Stat Rep, 2016 Jun, 96, Heron, M. (2017}. Deaths: Leadfng Causes for 2017;· Natl Vital Stat Syst;, 77. Hines, A. L, Barrett, M. S;, Jiang, J,, & Steiner, C. A. (2014). ConditlonsWlth the Largest Number of Adult Hospital Readmissions by Payer, 2011.:.....statiStlctJIBrief#172. Agimcyfor Healthcare Research and Qualfty; https;/fwww..hcup-us.ahrq.gov/reports/statbrtefs/sb172-Condlt1ons-Readmlsslons• Payer.Jsp Howell, E. A., Egoroca, N., Balblerz, A., leltlln, J., & Herbert, P. L. (2016). Black-White DTfferences In Severe Maternal Morbidity and Site ofCare.American Journal of Obstetrics and Gynecology, 214(1), 122.e1•122.e7.·https://dol.org/10,1016/j.aJog.2015.08.019 Howfader, N., ll!oone,AM., Krapcho, M., MiUer, D,, Brest, A., Yu, M.,& Ruhl, J. (2020). SEER Cancer Statistics Review, 1.975--2017. SEER. https://seer;cancer.gov/csr/1975_2017/lndex.html ttcyert, D., & Mlnlflo, A. M, {2020, July 15). Maternal Mortality In the United Stt1tes: Changesln Coding, Publication, and Data Release; 2018. https:/fwww..cdc.gov/nchs/matemal•mortaUty/lndex;htm Institute of Medicine. (2014). Dying In.America: lmptovlng Quality and Honoring lndMdual Preferences Neartf,e Endofufe. https://dol;org/l.0,17226/18748 Institute of Medicine (US) Committee on Quality of Health Care in America; (2000). Td Errls Human: Building a Sofer Health System. National Academies Press {US), http:/fwww..ncbl.nlm;nlh.gov/books/NBK22S182/ Kamal, R. (2017), What are the current costs and outcomes ,elated to mental health and substance. use disorders? Peterson-KFF Health System Tracker. https:/fwww..healthsystemtracker.org/chart• collection/current-costs•outc:omes"i"elated-mental-health.:Substance-abuse-dlsorders/ Leape, L, Berwtck, D., & Bates, D. (2002), Counting Deaths Due to Medical Errors~Reply;JAMA: the Journal of the American Medical Association, 288, 2405. https://doi.org/10.1001/Jama.288.19.2405JLT1120-2-3 Makary, M. A., & Daniel, M. {2016), Medical error~The third leading cause of death In the US. BMJ, 353, i,2139.·https://doi.Org/10.1136/bmj.12139 Mariotto, A. B., Yabroff, K;R., Shao, Y., Feuer, E. J., & Brown, M. L. (2011), Cancer Prevalence and Cost of care Projections. National Cancer lnsitute; https://costprojectrons.car\c:et.gov/ McCullough, K. P., Morgenstern, H,, Saran, R,, Herman, W. H.~ & Robinson, B. M. (2019}. Projecting ESRD Incidence and. Prevalence in the United States through 2030. Journal of the Amerfatn Society of Nephrology: JASN,.30(1}, 127-135. https://dol.org/10;1681/ASN.20180S0531 Medicare Payment.Advisory Commission•. (2020); Medicare Payment Advisor/ Commlsslorrs (MedPAC) Marth 2020 Report to the congress: Medicare: Payment Pollcy-ContextforMedfcare Payment Polley (Chp :f.J. http:l/www.medpac.gov/docs/defaultsourc:e/reports/mar20_rnedpac_ch1_sec.pdf?sfvr:sn=O National Quality Forum. (201:la). Naf,:Measure Evaluatldn Ctltetla. htt:p:/{www.qualltyforum.org/MeasUrlnLPerformance/SubmlttlnLStandards/Measure_Evaluation _Criteria.aspX VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.061</GPH> lotter on DSK11XQN23PROD with NOTICES1 National O.uallty Forum. {2012b}. Patient-Reported Outcomes In .Performance Measure~nt. https;/fwww..:qualltyforum.org/Publlcatlons/2.012/12/Patlent~ lteported_OutcomesJn_PerfQrmance.:..MeasuremenuspX Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48207 Natlonal Quallty Forum. (2016), Attribution-Prine/pies and.Approaches. https://www.qualityforum.org/Publicatlons/2016/12/Attrlbutlon_• _Prlnclples_and_Approaches.aspx National Quality Forum. (2017). NQF: Socia/ Risk Trial Final Report. https://www.qualltyforum.org/Publicatlons/2017/07/Soclal_Rlsk_Trlal_Flnal_Report.aspx National Quality Forum. (2018). 2018 lmpravlng Attribution Models Final Report. https://www,qualltyforum.org/Publicatlons/2018/08/lmprovlng_Attributlon_Models_Flnal_Report. aspx National Quality Forum. (2019). Healthcare System Readiness Final Report. https://www.qualltyforum.org/Publlcatlons/2019/06/Healthcare_system_Readlness_Ffnal_Report.as px National Quallty Forum. (2020). optolds and Opioid Use Disorder: Quality Measurement Priorities Final Report. https://www.qualltyforum.org/Publications/2020/02/0piolds_and_Opioid_Use_Disorder_Quality_ Measurement_Prlorltles.aspx Office of Disease Prevention and Health Promotion. (2020). Social Determinants of Health. https://www.healthypeople.gov/2020/toplcs-obJectlves/toplt/soclal-determlnants-of-health Philpot, L. M., Barnes, s. A., Brown, R. M., Austin, J. A., James, c. s., Stanford, R. H., & Ebbert, J. o. (2018). Barriers and Benefits to the Use of Patient-Reported Outcome Measures In Routine Cllnlcal Care: A Qualitative Study. American Journal of Med/cal Quality: The Of[fclal Journal of the American College of Medical Quality, 33(4), 359-364. https://dol.org/10,1177/1062860617745986 Rul, P., Kang, K., & Ashman, J. J. (2016). National Hospital Ambulatory Medical care Survey: 2016 Emergency Department Summary Tables. 38. Saran, R,, Robinson, B., Abbott, K. c., Agodoa, L. Y. c., Bragg-Gresham, J., Balkrlshnan, R., Bhave, N., Dietrich, X., Ding, Z., Eggers, P. W., Gaipov, A., Gillen, D,, Gipson, D., Gu, H., Guro, P., Haggerty, D., Han, Y., He, K., Herman, W., ... Shahinian, v. (2019). us Renal Data System 2018Annual Data Report: Epidemiology of Kidney Disease In the United States. American Journal of Kidney Diseases, 73(3), A7-A8. https://dol.org/10.1053/j.ajkd.2019.01.001 Schultz, E. M., Pineda, N., Lenhart, J., Davies, S. M., & McDonald, K. M. (2013). A systematic review of the care coordination measurement landscape. BMC Health Services Research, .13(1), 119, https://dol.org/10.1186/1472-6963-13-119 Sliva, M. J., & Kelly, z. (2020). The Escalatlan of the Opioid Epidemic Due to COVID~19 and Resulting Lessons About Treatment Alternatives. AJMC. https://www.aJmc.com/vlew/the-escalatlon-of-theopioid-epidemic-due~to-covid19•and-resulting-lessons•about-treatment-alternatives Singh, H., Meyer, A. N. D., & Thomas, E. J, (2014). The frequem:y of diagnostic errors In outpatient care: Estimations from three large observational studies Involving US. adult populations. BMJ Quality & Safety, 23(9), 727-731. https://dol.org/l0,1136/bmJqs-2013-002627 Snyder, s. M., Morse, S. A., & Bride, B. E. (2019). A comparison of 2013 and 2017 baseline characteristics among treatment-seeking patients who used oplolds with co-occurring disorders. Journal of Substance Abuse Treatment, 99, 134-138. https://dol.org/10.1016/J.Jsat.2019.01.023 VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.062</GPH> lotter on DSK11XQN23PROD with NOTICES1 Steiner, C. A., Karaca, Z., Moore, B. J., lmshaug, M. C., & Pickens, G. (2020). Surgeries in Hospital-Based Ambulatory Surgery and Hospital Inpatient Settings, 2014. In Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Agency for Healthcare Research and Qualfty (US). https://www.ncbl.nlm.nlh.gov/books/NBK442035/ 48208 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices The.Administration for Community Lfving. (2020). 2019Profile of Older Americans. 26. Throughout this re110rt, the relevanutatutory language appears In ttaliclzedtext. {n.d.). US Department of Health & Human Services. (2020), Report to Congress: Social Risk Factors arid Pe,formance in Medicare's Value--Based Purchasing Program. https.:/laspe;hhs.gov/system/flles/pdf/263676/Soclal-Rlsk-ln-Medlcare%£2%809(,99s-VBP~2ndReport-Executlve-Summary.pdf van Walraven, c., Bennett, c, Jennings, A., Austfrl, P. c., & Forster, A. J. (2011). Proportion of hospital readmfsslons deemed avofdable: A systematic review. CMAJ: Canadian MedlcalAssoclation Journal =Journalde.rAssodatlon Medlcale Canadlenne, 183{7); E391-402~ https:l!dol.org/10.1503/cmaj.101860 Ward, B; W., &. Schlller, J. S. (2013). Prevalence of multiple chronic conditions among US adults: Estimates.from the National Health Interview Survey, 2010. Preventing Chronic Disease, 10, E65. https:l!doi.org/10.5888/pcdl0.120203 Weston, c. M., Yune, s., Bass, E. B., Berkowitz, S.• A., Brotman, D. J., Deutschendorf, A,,Howell, E. E., Richardson, M, B,, Sylvester, c., & Wu, A. w. (2017). A concise "fool for Measuring care Coordination from the Provlder's Perspective In the Hospital Setting.Journal ofHospital Medicine, 12(10), 811817. littpS:/ldor.org/10.12788/jhm.2795 WIiiiams, M. D. (2020), Practical and measurable definitions of care coordrnatJon, care management, and case management; Translational BehrMorol Medicine, 10{3), 664--666. https://dol.org/l0.1093/tbm/lbaaooi VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00095 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.063</GPH> lotter on DSK11XQN23PROD with NOTICES1 WIison, N.1 Seth, P., Smith IV, H,, & Davis, N. L (2020). Drugand Opioid-Involved Overdose Deaths-united States, 2017-2018. MMWR. Morbidity and Mt,rtQ/lty Weekly Report, 69. https:l!doi.org/10.1558S/mmwr.mm6911a4 lotter on DSK11XQN23PROD with NOTICES1 VerDate Sep<11>2014 Jkt 253001 PO 00000 HHSM-500.2017• 00()601 Frm 00096 HHSM0 500-2017- Fmt 4703 00060t Sfmt 4725 HHSM-500.2017~ ~I E:\FR\FM\27AUN1.SGM Hf!Sr.1,-5()0.2017• 000601 Pttroderecomroend~iOl'IS related to..multistakeholde.r group input on .the selection of quality and HHSM-SOO.T0003 ~~lel'lg me11suresfor .l)lW~l'lt an:d pubUc;,reported prognims; Review. outcome measures fOr enclc>rse!'limror main~nance; e!lc:it ~ommendlltlonsfor·dlsparltv7SFCMC18F0001 seilsi:We meas1.1res; and identify socta I~lsk.trlal sources and standardsfor patienti~el social. ri~k f.i.ctor lnfof!'l11tlon for m.easuring equity, Devefoptechnicalg.uldanee on ee~ Pi'.licti~esfor oeve1opint& resting social and functional status-related 75FCMC20,F0001 riskadlustmentln qu;11!ty Risk Ad1ustment mea$urement. Meth<>ds Develop a measurement framework Measurement that,aqdres,ses pQly$ubs.tanc.e. us.e F@mewark for ·AddrHslng PPIQid,1nv:01v1n11 $Yl1thetlc.or semt,. Related.Outcomes .synthetlc.opiolds.fsssO).arnong 7SFC,MC20FOOQ2 lndivlduals,with co-occurr\ng'.' Among Individuals Behavioral 1:1!:lillth (BH)i;Qndltlons. W1t1reo.-oc:curdn11 Bllihavl0riil. Health Conditions Measure Appticiltions Partnerships Milr¢h27,ZOZO- March.26,2021, {Optlon:ve11i'2l May 15, Z020- M11Vl4, 2021 (Option Ye.1'2) June 1~, 202o~se11tember 1~.. 2021.1ease Year} Ame 3Q, 2020- ~e~ertlber 29, 2q2t(B;1$¢ Ye;t.rf Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 17:52 Aug 26, 2021 ~ndlx A: ZQaQA4ltfv~- Pa®rmecl U:rM'lar~CI;-" HHS 1. Federally Funded Contracts AWardedln FY 2020 $1,393,823 $418,163 $1,(196,931 $655',345' 27AUN1 ii 48209 EN27AU21.064</GPH> lotter on DSK11XQN23PROD with NOTICES1 48210 VerDate Sep<11>2014 Jkt 253001 HHSM,S00-2017.()006()!' 7S.FCMC20F000l PO 00000 Performanc;e Measures Frm 00097 HHSM,.S00-2017000601 CoreQuality 7SFCMC18f0009 (olfaborative: Fmt 4703 Sfmt 4725 HHSM,S00-2017• .ooq60f. Measures 75FCMC20F0004 E:\FR\FM\27AUN1.SGM 27AUN1 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 17:52 Aug 26, 2021 Patient-Reported .Outcome Measures• tq Digital PRO ldentlfytheattril:lute9ofh1gh quafi.tv patie11t~reporteg qutc:ome measures(PROMs) and.cre;1te.$tep- by.:step guldante for using the$e PROMS as the foundation for deyelqpjng di!lita! pat)en(-reported 011ti:ome.performance .mea$ures (PRO-PMs). Identify.and al',gn h'-'1 value, hJs/1· lmpa~t, ~Jde11ce-ba$ed measures 11.cross PUbllc l!rid Mvatii payers .that promote better patient outcomesandprovide.useful ir:if!lf"11l~n fQr imprcweme11t, de~,Slon ~kin& and payment,, lde11tlfythe causes, nature, and ~nt ¢ Ef1R data q1,1a!itv issues kevera&il!i E~ctro11ic <!.hd ~omme11d bestpraptic;es fqr Heal.th Record•addressif1&.these .issues toe.increase sourced Measures scientific acceptability (i.e., September 1,2ow·- November.30, 2021 {Base.Year) $774,625 September 14, 2020- September 13,2021 (Option Year 2) $264,013 September 25;. 21120, September 24, 2021 <e•se Ye,ar) $.714,!)99 reli11biHty,;Yl!lid.itvl,1;1fe .ind u~blliW,.Md feaslbifity.of eCCIMs, HHSM•S00-2017• 000601 HHSM.SOO-TOOOl Corise11Sui,Based Ef1dorsemenhnd maintenance of Endorsement.and endorsement of standardized he.althcare. performiince .m.e.asures Maintena11ce 9f Performa11ce September 27;2020.• S~P!:er:nber2&,io21 (Option Vear3) $9,956,081 Measures HHSM~SOQ-2017000601 H.HSM-.SOO-T0002 I Annual Report to ~ngres$ ~porttQ Con!!~ and the .Sec:ret1rvthathl&bli1ht~tb, implementation .of q1,1alitvand efficiency meas.uremem initiat'r,es undertheSocialSecurityAct Septembet27, 2oio-.SePternb.etili;.2021 {01)1:ion Vear 3) $131,543 • EN27AU21.065</GPH> lotter on DSK11XQN23PROD with NOTICES1 VerDate Sep<11>2014 Jkt 253001 75FCI\IIC20FOOOS PO 00000 Attribution for CritJ<:;al lllne.sond lnJurv Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 17:52 Aug 26, 2021 HHSl\llsSIJ0.2()17000601 Jlevelop recommendations.for clewtoping gli!Ogr;aphtcal/1»pulc11;ion~ba,ed Septemtier21l; 202()• ~Ptember21,2021 attribution models applicable to (!lase Ye;arJ .quality measurement of high-acuity la\merpncy ~;al'I! sens1i1ve conditio!'.1$ $711(),472 lECSCs). Frm 00098 HHSM-Sob-2011000601 Fmt 4703 TOTN- Haac>ilatafJ 75FCMC~F0()()7 !4verasing !lllalitv Meas1.1rement.to Improve Rural Health Develop a.measuremer1t framework l!nkingquality ofcaredellvered by Sla\Piem.~.r 1>:,20,20-J1,11y5;2021JOptlon teiehe•lth, healt11care:s'l$te(li Yiearli readl!t¢Sit, ;al)f:1 he"lth 0Ut\':OOOe$in a disaster. $41!6,()58 ·$16,734,053 Contract Value Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 ;I 48211 EN27AU21.066</GPH> 48212 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 2, NQF Flnanc;ial Information for FY 2020{unaudited) 20,882;064 325,000 277;013 397,016 ContribUtlonsand-Grants Program Servtce Revenue investment Income Other Revenue TOTAi.REVENUE Grant$ and Simi Jar Amount, Paid Benefits Paid .to or for Members Salarles,other Compensation,Employee Benefit, Other etpenses1 $Z1;881,093 - .. 11,620;015 7,666,433 VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 $19,286,448 PO 00000 Frm 00099 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.067</GPH> lotter on DSK11XQN23PROD with NOTICES1 TOTAi.EXPENSES Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48213 Appendix B: Multlstakeholder Group Rosters: Committee, Workgroups, Task Forces, and Advisory Panels NQF ensures there Is broad representation from the healthcare sector across alllts convened committees, workgroups, task forces, and advisory panels. As a consensus-based entity, all multlstakeholder representatives must undergo a disclosure of Interest process prior to being appointed. This allows for a fair, open, and transparent process. During this time, NQF did not identify any known conflicts of Interest that would undermine the objectivity of the dellberatlons mentioned above. Consensus Development Process Standing Committees CO-CHAIRS John Bulgllr, DO, MBA Geisinger Health Cristie TraVls, MSHHA Memphis Business Group on Health MEMBERS lotter on DSK11XQN23PROD with NOTICES1 frank Brigs, PhannD, MPH WestVlrglttia University Healthcare Mae Centeno, DNP, RN; CCRN, CCNS, ACNS-BC Baylor Health Carli System Helen Chen, MD Hebrew Seniorlife Edward DaVldson, PharmD, MPH, FASCP Insight Therapeutics Richard James Dom Dera, MD, F.AAFP O~lo Family Practice Centers and NewHealth Collaborative Paula Minton Foltz, RN1 MSN Patient care Services Brian Foy Q-Centrlx, LLC Lisa Freeman Connecticut Center for Patient Safety Faith Green, MSN, RN, CPHQ. CPC-A Humana Leslle Kelly Hall Healthwlse Mlchelle Lin, MD, MPH, MS Icahn School of Medicine at Mount Sinai Dheeraj Mahajan, MO, CIC, CMD Chicago Internal Medicine Practice and Research (CIMPAR, SC) Kenneth McConnochle, MD, MPH University of Rochester Medical Center leyno Nixon, Phi>, MPH Washington State Health Care Authority Amy O'Unn, DO, FHM, FACP Cleveland Clinic Enterprise Readmission Reduction Gt!tlthl!r Pennlnaton, RN, BSN Bravado Health Clrola Pulaskl, MSA, BSN, CPHQ VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Centene Pamela Roberts, PhD, MSHA, ORT/L, SCFES, FAOTA, CPHQ. FNAP, FACRM Cedars-Sinai Medical Center Shella Roman, MD, MPH Johns Hopkins Medical Institutions Tori Shoulder, RN, BSN, MHA, CPHQ. CPC eavcare Health system Chloe Slocum, MD, MPH Harvard Medical School Allthony White Patients Partnerittg with Health systems Behavioral Health and Substance Use Standing Committee CO-CHAIRS Peter Brisa, MD, MPH Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotioll Harold Pincus, MD NewYork-PresbVteilan Hospital, The University Hospital of Columbia and Cornell MEMBERS Mady Chalk, PhD, M$W The Chalk Group DaVld Elnzlg. MD Children's Hospital and Clinics of Minnesota Julle Goldstein Grumet, Phi> Education Development Center/SUicide Prevention Resource Center/National Action Alliance for Suicide Prevention Consaince Horgan, Sci> The Heller School for Social Policy and Management, Brandeis University LlsaJensl!n, DNP;APRN Office of Nursing Services, Veterans Health Administration North Dolores (Oodl) Kelleher, MS, DMH DKelleher Consulting Kral& Knudsen, PhD Frm 00100 Fmt 4703 Sfmt 4725 Ohio De~artment of Mental Health and Addiction Services Michael R, Lardieri, LCSW Northwell Health, Behallioral Health Services Une Tami Mark, Phi>, MBA RTI International Rllquel Mazon Jeffers, MPH, MIA The Nicholson Foundation Bernadette Melnyk, PhD, RN, CPNP/FAANP, FNAP, FAAN The Ohio State Unlllllrslty Laurence MIiier, MD University of Arkansas for Medical Scleneils Brooke Parish, MD Blue CrCISS Blue Shield of New Mexico David Patlnlli MO Kaiser Permanente San Francisco Vanita Plndollll, PhannD, MBA Henry Ford Health System Lisa Shea, MD, DFAPA Lifespan Andrew $perfln11, Jo National Alliance on Mental Illness Jeffery $usman, MD Northeast Ohio Medical University Michael na11111e, MD HealthPartners Medical Group Bonnie Zima, MO, MPH University of California, Los Mgeles (UCLA) Semel Institute for NeurC1Science and Human Behavior Leslie s. zun, MD, MBA Sinai Health System cancer Standln1 Committee CO-CHAIRS Ka111n Flelds, MO Moffitt Cancer Center Shelley Fuld Nasso, MPP, CEO National Coalition for Cancer Survivorship MEMBERS Afsaneh Barz!, MD, PhD USC-Norris cancer Center G111pry Bocsl, DO, FCAP E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.068</GPH> AH-cause Admissions and Readmissions 48214 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Donald IClltpard, .MD, FAAFP OasisMD Matthew FacktOr; MD, FACS (lnrredw) Dl!clore Consulting Elltn HIile,-. PT, EdD,CCS, Geisiti&er Medical Center FAACVPR, FAPTA Cancer Center Heldlfloyd Patient Advocate Bradford Hlr:llth, MD ~ ffo&ellll'llllet;PN>; MN, APRN/ARIIIP, CDE, NTP, .TNCC; CEE Oncology Nurse Practitioner W-riilohnson Fight Colorectaf Cancer J. IAonard Uclmallflikl, MD, MACP• Amerii:an Cancer Society Stephen I.well, Ms Si!~ canw Care Alliance. Patient and AdlllsotyCOuncil . Jennlfar Malin, MD, PliD Anthem, Int. Jodi Maranchle, MD, l'AC5 Unlverslly of l'fttsbu1&h Oen!Han-, MBA . City of Hope cancer Center Benjamin MoYsas, MD Henryfo«I Heallh System Beverl; Ref&le,PhD, RN University of Cincinnati College of Nutsing DallldJ. Sher, MD, MPH OT soothwestemMedlcaltenter Dalllelle Zlemk:kl, Pham!D Dedham Group Cardiovascular Standing committee CO-CHAIRS MayGeorp, MD, MSPtl, FACS, FAHA Centers.for Disease Control and Prevention (CDC! ThomuKotl:1111, MD, MSPH Consulting cardiologist, · HealihPartrters MEMBERS Unda Brigs, Dt<IP Geofte WashingtOn University, School of Nl.ltsing LulaCho;MD Cleveland Cllnit Helane Claytori-.teter, OD CtossOVer Heallhtare Ministry ,mfllhelewlal!d, MD University of Colorado Mlchael crouch, MD, MSPH, .FAAFP Texas A a M University School of Medicine Tim Dilwhl'!ISt, MD, FACC Kaiser Pi!mr.lnente 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Medlink Advl!ntage Sliman MaJullllfar, PIID Washington State Health Care Authority AleflyahM91lwala, MS,MPH UPMC Hea.lth Plan Pamela Robeltll, PhD, OTR/L,SCffS, Amer!Clln Physical Therapy Association SIGNAi.PATH lotter on DSK11XQN23PROD with NOTICES1 DlmishKalra Rush University Carolln;u:HeallhCareSystem Howard Elsen, MD Mechartlcal ClrcillatorySupportal\d Adwnced Heart Faffure Nllftall ZVIFranket, MS ~Clien, MD, MBA, FACS VerDate Sep<11>2014 Kumlll' Dharmarajan, MD, MBA aover Health Wllllam DowrleY, MD . Charles Mahan, Phill'lilD, PhC, RPh Presbyterian Healthi:are Servfces am:I Unlvetslty of.New Mexico Sil!aNn Mattke, MD; DSc University of South em California 6-Mayes;JD,MMSc Patient Story Coach/Writer Kristi lilllu:hell, MPH A\lalere Health, llC. Jaon.Spander, MD, MPH, FACPM ·Amgen,.lnc. FAOTA, CPHQ, FNAP, FACRM Cedars-Sinai Medical Center Mahli Senathlralah, MBA IBM. Watson Health Matthew11tmllSIS; DPT Hosl)ltal for $pedal surgery Sophia Trlpol MPif Families USA Danny van a.wan. RN,MPH Health Hats Gerlatrlcsand PalllaM Care Standing. Committee CO-CHAIRS S-nStrcing HeartValueVoice Colorado Mlllden Vidovich, MD R. Selin Mol'rlsoli. MD Patty and JW!f Baker National PalHative care Center; National Palliative Care Brown VA Medical Center . DaYlll Wlllll'lllQI, MD, PhD, FACC university of California Research Center;HeifibergPaliative Care IIUtitUte, Icahn School of Medicine.at Mount Sinai DuorahWaldrop, PhD, I.MSW; Coshnd Effldency standing Committee UnlVerslty of Buffalo, Schoof .of Social Work Unfvetsity of Illinois at ChlalgO, Jesse ACSW CO-CHAIRS lCrlstfne Martin Ancliii'IDII; MBA BoO>: Allen Hamilton SUnny JhamnanL MD Dignity Health a Banner MEI\ABERS Robert B!llley, MD Johnson &Johnson Health care System$, Inc; BIJan Boi'ah, llilSc, l'liD Mayo Clinic College of Medicine Cory Byrd. Humana, fne; Amy Chin, MS Greater New York Hospital As:soclation · Cheryl Damberr, l'liD RAND Corporation LliidsayEl'ldlson, MPH Integrated Hftlthcare Associatiori (IHAI RAND Corporatlon/UCI.Asthool of PUbllc.Healih EmillilHoo. Pacific Business Group on Health (PBGH) Sean Hopkins, BS NewJersey Hospital Assoc;lation Jonathall Jilffr'ey; MD, MS, .MMM IJniverslty of Wisconsin School of Medicine and Public H!!Blth Fmt 4703 Morton Plant Mease/Bay care Health System . Sn!e Battu;MD MayoCllnic Samira llilcbilth, t.tsw, FACHl1, lHD Hope HealthCl!re Sen/Ices· AniyJ. Berman, RN John ii. Hartford Fmindation C!eailllil ea,,, DO, FAAHPM,.FAAl'P Hilsph:eofDayton MailllnGrant, DNP,CRNP CoalitiOn to Transform Advanced Care (C-tAC) Georp Haiidlo,lfCC,CSSBB Heallhcare Chaplaincy Arif H. Kama~. MD; NIIA, MHS, FACP, FAAHPM ouke Cancer Institute SUIIMI Johil$on, MPH, RN RlshaGldnm, Di'PH Frm 00101 MEMBERS MaiBJa Atldnson, DMln, lfCC Sfmt 4725 NatlOnal Hospice and Pall!ative Care Organization lll'llce:Knebl; DO, MBA, FAC()f, FACP Urilverslty o:I North Texas Health Science Center at Fort Worth Christopher laJltOn, CAE The Society for l'ost-Al:Ute and Long- Torin care Med1c1n.e Katllerlne Udltenbel'C, DO, MPH. FAAFP E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.069</GPH> University of Colorado Hospital cnntcal Laboratory Brent llravelnan, Pb.I>, OTR/1. FAOTA University of Texas M.o. Anderson Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Notthwestem. University Feinberg Sthool of Medicine/AM and Robert H. Lurie Children'& Hospital PhannD,MS Clink:al l:'harmaci:St, Self..Empll)Y!!d 1.1it1ra Porter, MD CanterAlliance Lynn Rellike, PhD, ARNP, FAAN VA Puget Sound Health careSystem Colon CO-c:HAIRS Gem Lamb, PhD, RN, FAAft Linda Schwlm111er,JD . New Jersey Health care Quality Institute Christina S..I Rl'ldlle, MO, MSPH University of callfornia San Francisco, Jewl$h Home of San Francisco Center for Research on Aging Janella Shnrw, RN, BSN, ~ CPHQ Stl'.atls Health .. PaUll:,T-, MO, MSPH,CMD, FAAHPM, AGSF Dell Seton Medical Center at. University of Texas, Jltustin s.11111 Thirtwel~ ·JIISc, MSc(A). RN, CHPN, CHPCA, AOCNS H. Lee Moffitt Canter center: and Resean:h lnstitllte H(IS!lltal, Ilic. Neurology Standfn1 Committee CO-CHAIRS DlwkllCnowlton, MA Retired . . .. Da¥k1 llrsc:hwel~ MD, MSc University of Washington, HarborvleW Medical Center MEMBERS Mary Kay 8allaslotu, MD. International Alliance for Pediatric Strokit ~BautlSta,.MD cievetand Clll'llc Neurological lnstiiute Epilepsy Center JilnesBurlril,ll,1D University of Mldllaatt .. .. .. . Yalarte Cotter, DrNP, AGPCNl"-ac, FAANP .lohn Hoplcins Schoof of Nursing Rtbea:a DeSl'OSC:ller, MS Health'Resources and Service$ Adminlsttation Brldford D11:kerson, MD, MMSC Massadlw;etts General Hospital Charlotte.Jona, IVID,Phb; MSPH food and Drug Administration Melody Ryin, Pha-111D, MPH University of Kentlicky College of Pharmacy .Jane SUlllvan, PT, PHS, ft'I& Notthwestem University Kelly Sulivan, Phi> lotter on DSK11XQN23PROD with NOTICES1 Harvard Medical School DolllllaSNH; University of Wisconsin, Madison, Sthool of Social Work 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Peter lllomas,JD Pyles,SUtter&. Verville, P.C. Rosszatonte, DO Patient Experience and Function Standing Committee Trac:y Schroepfer, PhD, MSW VerDate Sep<11>2014 Georgia Southern University Patient safetystandlna Committee CQ-CHAIRS Ed Septlll1us, MD Mltdlcal Director Infection PreVentlon and EpidemlolO&V HCA.and.Profes.for mInternal Medicine Texas A&M Heailh Sclence Center College of Medicine, Hospital Corporation of America 1ana Tinen, PhD, At.SW Patient safety .Directof,Utah Department ar Health Arizona State University IMPartl'fda<J United Hospltiii Fl.ind Christopher Stllle, MD, MPH, FAA¥ University of Colorado School of Medldm1. & Chidr11n's Hospital MEMBERS .MEMBERS .i.on Adelman, MD, MS RJchaidAnt-'11, MD; MS Boston Chlldren'sflospltai,.Harvard Medical. School York-Presbyteflan·Hospltaf/Cofilmbla University MedicalCenter Alirhlnne Boissy, MD, MA Cleveland Clinic Doilald euey, MO, MPH, MBA, FACP, FAHA,FAAPL,DFACMQ Anleflcan College of Mt!dk::al Quality, fACMQ) Ai'lel Cole, MD . Flol'tda state university College of £111lly Aaror1s11n. MD MassachUsetts General Hospital EllssaCharbonnuu. DO, Ms Encompass Health Corporation Curtis Colins, PhannD, MS St..J~h \illem Health System ·t,llellssa Danforth, BA The LeapfrQg Group 1'heNA Edelmln, MPH,lNHA Medldne Orlando Campus RyJ!ff.CO....,MD,MPH Univetsilyof Wisconsin-Madison Sharon Cioa, I.ISW-S '{he OhioState UniversltyWexnlll' Medical Center . Christopher Dall, MBA.RN, CPHQ erlstol-Myers Squibb Company Sharl Erickson, MPH Btlstol-Myers Squibb-COlnPl!IIY DaWn.Hohl, RN, BSN, MS, PhD Johns Hopkins Home Care Group Shenle Kaplan, Phi>, MPH. . Unlven:lty of callfotnla Irvine Schoof of Medicine. Tr8cay l<usnlr, MBA Seattle canl$r Care All!ance Brenda tuth, MHSA, l'MP Nliw Jersey Hospital Association Teny Fall'banll:s, MD,MS, FACEP MedStar Health Ullee Gellnas, MSN, ltN, Cl'PS. fAAN s.rrercare TeXaS; Uni\lersity of North Texas Health Science Center Johll JalnG, PhD Patient safety Aml!ridl .. Stephen lawless, MD, MBA, FAAI', FCCM . Nemours Children's Health System LIA Ml:Glffert S,ife Patient Project, consumers Union . . . Westat Brian Undltelt, IISW/MMHS . Consumer Coalition fot QualllyHealth care Ulla MOrr1se, MA .. Patient &Family EnpgementAflinlty Group National Partnershlpfor . 511san Moffat-Bniat, MO, Phi>; MBA, FACS Ohio State Univetsity'sWl!liner Medical Center A-Myrb, RPh,. MAT Island PerReview Organization (IPRO) Jafii1e RofleYiOf<IP, NPD-BC, CCIIN-k cov-nt Health System . . .. Patients Rando Oster; MBA Help Me Health Charissa Pac:ela, MD University of Pltt$burgh Medtcat IJavld SeldiuMurum, MD, FACR SUm!cHealth GeetaSood,MD, lcM. The Societyfor ftl!lllthc:ili'e IAriilid.Pat'lil, RN, MA. Cl'HQ. John Hopkins University, Pascal Ep!demliilogy of America David Sillckwel, MD, MBA Center (UPMC) Metrics FN~Q Metropolitan Jewish Health System O,bra~ MD; MPH .. UCl.A/.JH Borun Center, VA GRECC; RAND Health Ellan Schult!;, MS Arnerica!l lnstitl,ltes for Research Frm 00102 Fmt 4703 Sfmt 4725 Trac:y Wang. MPH. Anthem, Inc. Kendd W.bb,MD, FACEP University of Flortda Health systems, University al Florida Health JacksonvlUe E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.070</GPH> Anthem Blue Cross and Blue Shield Kelly Mlchaeison, MD, MPH, fCCM, fAP 48215 48216 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Donald Yealy, MD, FACEP University of Pittsburgh Yanllng Yu, PhD Washington Advocate for Patient Safety Adam Thompson. BA Kennedy Health AUlance CO-CHAIRS Thomas Mclnemy, MD Retired Amir Qaseem, MD, PhD, MHA American College of Physldans MEMBERS Lindsay BOtsford, MD, MBA, MBA/FAAFP MEMBERS Perinatal and Women's Health Standing Committee CO-CHAIRS Klmberly Grtgory, MD, MPH Cedars-Sinai Medical Center carol Sakala, PhD, MSPH National Partnership for Women & Families MEMBERS JIii Arnold Maternal Safety Foundation J. Matthew AIIStln, PhD Faculty Johns Hopkins School of Medicine Jennifer Balllt, MD, MPH Metrohealth Medical Center Amy Ball, DNP, RNC-09, NEA-BC, CPHQ WOl1'1M's and Children's Services and Levine Cancer Institute, Atrium Health Martha carter, DHSc, MBA, APRN, CNM WomenCare, Inc. Tracy Flanagan, MD Kaiser Permanente Ashlty Hirai, PhD Health Resources and Services Administration Mambaralllbath Jaltel, MD Parkland NICU, University of Texas, Southwestern Medical Center Diana JoDes, CNM, MS, PhD American College of Nurse- l\llldwlves Deborah KIiday, MSN Premier Inc. sarah McNel~ MD Contra Costa Medical Center Jennifer MOON, PhD, RN Institute for Medicaid Innovation Krl$tl Nelson, MBA, BSN lntermountaln Healthcare Jullet M, Nevins, MD, MPA Aetna Shella OW.ns-Colllns, MD, MPH, MBA Johns Hopkins Healthcare, LLC Cynthia Pelltsrlnl March of Dimes Diana E, Ramos, MD, MPH, FACOG Los Ar,geles County Public Health Department Naomi Sc:hllfllro, RN, PhD, CPNP Step 2 School of Nursing, University of California, San Francisco Prevention and Population Health Standing committee John Auertiach, MBA Trust for America's Health Philip Albert~ PhD Asscx:latlon of American Medical Colleges Jayaram Brlndalll, MD, MBA, MPH AdventHealth Ron Blalek, MPP, CQIA Public Health Foundation I, Emlllo C:anillo, MD, MPH Weill Cornell Medicine Gisi Chawla, MD, MHA Children's Minnesota Larry Curley National Indian Council on Aging Blll'ry•lewls Harris, II, MD Corlzon Health Catherine HII~ DNP, APRN Texas Health Resources Amy Nguyen-Howell, MD, MBA, FMFP America's Physician Groups Ronald Inge, DDS Delta Dental of Missouri Julla Lotan, MD, MPH California Department of Health Care Services Patricia McKane, DVM, MPH Michigan Department of. Community Health Amy Minnich, RN, MHSA Geisinger Health System Brice K. Muma, MD, FACP Henry Ford Physician Network Jason Spangltr, MD, MPH Amgen,lllc. Rosalyn <:arr Stephans, RN, MSN, CCM AmeriHealth Carltas Matt Stiefel, MPA, MS Kaiser Permanente Michael Stoto, PhD Georgetown university Ar:tun Venkatesh, MD, MBA Yale University School of Medicine Renee Walk, MPH Wisconsin Department of Employee Trust Funds Whitney BOwman.Zatzkln, MPA, MSR Rare Dots Consulting Primary Care and Chronic Illness Standln1 committee CO-CHAIRS Dale Bratzler, DO, MPH University of Oklahoma Health Sciences Center-College of Public Health Physicians at sugar creek WIBlam Curry, MD, MS Penn State Hershey Medical Center Klm Elliott, PhD Health services Advisory Group, Inc. Scott Frltdman, MD Florida Retina Consultants Donald Goldmann, MD Institute for Healthcare Improvement v. Katherine Gray, PhD Sage Health Management Solutions Faith Graen, MSN, RN, CPI-IQ, CPC-A Humana Danlel GNtnlnSel', MD The Permanente Medical Group Starlin Haydon-Graattlng, MS, BS, Phann, FAPhA Illinois Pharmacists Association Jeffrey Lewis, BA El Rio Community Health Center Catherine Matlean, MD, PhD Hospital for Special Surgery Anna McColllstaNillpp Galileo Anlllytics SonaD Narain, MBBS, MPH Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health James Rosenzweig. MD Boston University School of Medicine, RTI International Victoria Shanmugam, MD The George Washington University Rlshl Singh, MD Clevaland Cllnlc WIUlam Taylor, MD Harvard Medical School Johll Ventura, DC American Chiropractic Assotlation Renal Standing Committee CO-CHAIRS Constance Anderson, BSN, MBA Northwest Kidney Centers Lorlen Dalrymple, MD, MPH Fresenius Medical care North America MEMBERS Rajesh Davda, MD, MBA, CPE Ci&na Healthcare Elizabeth Evans, DNP American Nurses Association Mk:hael Fl$thet, MD, MSPH Department of Veterans Affairs Renea Gerrldc, MD, FA(P Renal Physicians Association/Westchester Medical Center, New Vork Medical College Stuart Grnnsteln, MD Montefiore Medical Center MllceGuffey VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00103 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.071</GPH> lotter on DSK11XQN23PROD with NOTICES1 ~ Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Tl'easurer,Dialysis Patient Otlzens) Debra Hain, Phi>, APRN, ANP..IIC, GNP-BC, FAANP American Nephtology Nurses' Association UniVersitY of CA Health Pl!ln kartlynne lennln,. llftHA, UISW Telhgen.West Franklln Maddux, MD,FACP Fresenius Medical care North America AndNwlllarw, MD; FACP, FASN National Institute of Diabetes lli'.id Di&eStlVe Kidney Diseases-National lotter on DSK11XQN23PROD with NOTICES1 surgery Standing FASCRS University of Perinsylvanla/Amerlcan 5oclety ofAnestheslolo&ists Wllllam Gunllar, MD,JI) Veterans' Health Administration Unlwrslty of Colorado Sr.hoot of Medicine 17:52 Aug 26, 2021 Jkt 253001 PO 00000 1lsa lats, MD, MSPH, MBA. FAQJ Medlclne{Monteflore Medical Center Cllfflli'dKO, MD,.MS, MSHS, FACS; Lee·Flilllshar,MD Patients . . . .. Yale New Haven Health System Mahesh ICrlshnan, MD, MPlt, MBA, FASN D8Vlta Healthcare Partners, ·1nc; Albert EinsteinCollege of Cornnilttee COCHA1RS MEMBERS AshrlthAmamath; MD Slitter Valley .Medical Foundation Kenya Brown, LCSW-'C Fresenius Medical Care TempEatmon Children . Alan Kltpr, MD Fred..ickKaslcel, Ml>, PhD Children's HoSpital at Mont!!flore Myra Kleinpeter, MD; MPH Tulane UnlvetsltySchool of Medicine Institutes.of Health Jtssle flavllnllc,. MS, RD, CSR, LD oreaon Health &Science llnlvers!tv Mark lllltlrownl, MD SoothemcaRfomia·Permanente Medical Group Mlchael Somers, MD American $ocietyof Pediatric. Nephtology/HaMrd Medical Sdlool/Bostonthllilren'sHospital Bobbi Wacer, MSN, RN American Association ofl<iilney John Wa,rier, MD, MIA Kings County Hospital Center Jmhia Zlli'lilky, MD, PhD Nemours/A.I, tl~Ho.,pital for VerDate Sep<11>2014 Lori Hartwel Renal Support Network UCLA Schools. of Medicine and Publlt Health Barbara Levy, MD'. FACOG, FAC$ American College of Obstetricians and Gynecologists ShawnRlil1i81, MD, MStE llOstOn Children's HOSpltal Christopher Salpl, MD, MPH Ul'llversltyoft:alflwnia,1..osArigeles sahlatoAI T. Scall, Ml>,.FACS,RPVi :University of Rorida-Galnemne Patient Representative Ellsabeth En!ksoll, MD, MPii, f'AtOG, FACS Dartmouth. Hitdlcock Medical center Frederldt Giwer, MD John flandy, MD Alan Slperstelft, MD Cleveland Clinic Josh11111>. $teln, Ml>, MS llniversltyof Mlthl&an Larisa temple, MD Memorial Sloan-Kettering Canter Center · tcevln w.ia, MHA Hospital for Special Suraery American COiiege of Chest Physidllnt MarkJarnm, Ml>, MBA North Shore-OJ Health Systt!ln Vllm11JoSeph, MD, MPH, FASA Frm 00104 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.072</GPH> UMB Bank (Board of DltectOl'S 48217 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices ApperKl~C:$clentfflc Methods PanetRoster Columbia Unl\iersify; College of Henry Fl!t'd Heil11h System Physidali~ alldSu,aeol\s/ MEMBERS "Mattlwltki; PhD Armstrong Institute forPatlentSafety andllUlllltyatJohnsHopklns Medicine IIIJln IIOlill; MSt; PhD MayoCll!!I~ Jcihlt Bott, MBA,.MiSW cwumer Rel)brts lacy.Fabian, PhD The MITRE Corporation lotter on DSK11XQN23PROD with NOTICES1 $imst!ffl)it;PIID ~ttlille~1>rlll!lnstltUte Sberrlilkaplan, PhD; MPH ~rill Ku!lf$cb, PltD;RN.;ac..~ Mernof/al Hermann Health System Paid Kui'lilMkY; MD Avalete Health De1lkl N"9117. PhD 17:52 Aug 26, 2021 Braridels University PalrkkRlimmo, MD, MPH University. of callfomla.o.vis UC IIW'le School of Medldn.e CO-CHAIRS ChrllltlUefllaiid; PhD VerDate Sep<11>2014 Marybilth. Fllqlllar, PIii>, MSN, RN American Ui'ologlcalAssodation Jeffrey Geppert, EclM, .., Jkt 253001 Columbia HsrtSource ztlenqlu Un, PhD Vale-Ne\¥ ~aven Hi:lspltiil Jac:k Needlam11t;PhD UlilW!'Sittof ~lfbrrilalos Aliaelei .PM .. ... . .. . Unlverslty·of TeJCas MDAnde!Son cancer Center Terrf Wtliho~ PhD; RPh, CPffQ, .FAPhA University ofA,lzbmi; Colle!i! of Pharmacy ElfcW~PhD;MS EllfiMNucclo; PhD Ftuen111s Medilial care North V11lwrsifyllf•·eo1oradb,Anschutz IVledlcat campus Stan O'Brien, PhD. Duke. Unl\/erslty Miiidlca!Center America 5!Wn•Whftii,PIID, RHI~ CHDA the James Canm Hospital atlhe Jllnnlftr Ptllotf, PIii> PO 00000 Mathematica POl!c\l Research AlixSO.Hllrrls; PhD, MS Standford Unl\,e!'Sify R-ldWlllers, MD; MilA, ftnMA, Frm 00105 Fmt 4703 .OhlOStatfl Ulll\,e!'SltyWl!lmel' Medlcal center Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.073</GPH> 48218 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48219 Appendix D: NtAPMeasure Selectlo11 Qfterla MAl'uses lts:MeasureSelectlbnCrlterta (MSC) to guldelts ~lewof measuresunderconslderatlon, The Msc iil1! intendecho a$$lst MAP With 1dentlfy1n1chatacterlsttcsthataN1 assoclatedwi1:h tdeatmeasure sets used tor public res,orttng>and payment programs; The MSC are riot.absolute rules; rattier, thevare meant to prov}de-generalguJdance on measure selection dectstonsand to complement program-specfflc stati.itorv and regufatory rec:ru1remems.1he.c:ehtral tocusshould i:ieon the. selectioi'I of htghquailty measures·that.optlmally address health system Improvement prlorltles, flll•.crltfcal.measurementpps, and tncreaseallgnment. Although c:ompetlng prloritlese>ften need to bewelghed agal~ one another, the MSC cartbie used as a·teterencewhenwaluatlngthe•relattve strengths andweakhesses ofa programmeasureset, and howtheaddltlonofan lndMdual measurewouldcontrlbutetothe.set The MSC haveevQ[ved over time to reflect: the lnput oh wide variety ofstakeholdiers, tod~ffl!lne whether a1T1easure should. be considien!d for a speclfled prografl\ MAP evaluat;es ~hie measures under constdetatlon against the Ms.c. Acfdlttonaliv, tht MSC serve as the bastsf'ot the prellmlnaryanalyslS algorithm.MAP members are expected tofamlllarlze themselves. with the criteria and use them to Indicate their support for a measure underconsJderatlon •. 1. NQF-etldolffi/miosures.arerequiredforprogrammeasure.sets, unless··norelevant e,:,dorsedmeasures are available to achieve acriticalp,ograrn objective, Demonstrated·by•aprog,r;,m.meas11re·set..thatcontalnsmeas11resthatm«etthe.NQFemlorsement crlterf~.lnclu"""g•lrnportance•torneasuream:trepo,t.sclentlflcoc;ce~IHlltyofmeasurepro,,ertles, '(eoS1bH1ty~. usabllity·tffidUse,ondhamt0nlttnionof'tornpetlif~ ondrelorettmeasures sub-o(cedoit 1:t Meosutes'thtitenotNQF~slialiftltiesulmllt:tedft>r1indorieinenrf se/ectedtomeeta•specl/fcprogntmneed. $,,b-o(cedoft ~ •M~ure.stttati~f!adetict~em~.•orh~~ilsubtttlttedlot S U ~ 1.!I en~ment.an.d~renoten~ffiof;lidhe•:remr,W!dfro,n. proJli'fims. Miiasuiesthataielh.~•mitlis{J;e;, tlif:i,idotit)~ldlietorisldeiet:t.Jot removotfn)m.p,:ograms, 2. Proftarn rJletisfl.te$etl1CtivetypromQte$ k~y tleolthcaNimprovementprloritres; Siicljas th~ highllghtdinQ.il~ •M~nltlg/,JIMeosures"#ramtwotk: Demon~t,y.r,progrr;,m,neasurese,thatJ1rQfl'lotes.lmfJl'OVJment11t. tceYnatk1nalheatthca,e P~s.suc;h·asCMS~.~n.1njJil1·1,xeriSUl'iis.FtrJmeworl( Otherpotentto/J:onslderotfonslilcitide tiddtfflftl!lemer,iifgpul)/k#eQith f.'Qrwemsanrie11S:iJrlfill•that th!f m'i.lddtfflesfceV.tmprovementpmiittlesforatfpfo.tlldets; 31 Prog.ram measutesetisr:espqnsfve:to~;Jfc.p~rogoa~.at,dtequii;elilents. Demonstmtedby•aprr,grarn.,mms11resetthatls1ftforfJllfPJ1$e".for.theportfcularprogram . f l l ~ JJ ~m~sfftlilChldes~u,atareapplfc:iililetaOlfl! ~ r e l y teitetl/r,rt/tttprpgf4tn'Sf~iler!ta(f!sett/Jlgf$J, k'ill!l(s}of VerDate Sep<11>2014 17:52 Aug 26, 2021 a, Jkt 253001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.074</GPH> lotter on DSK11XQN23PROD with NOTICES1 sulkilredon ana&sJ$;•t111tlpop,.1/att.tkffs), Memare settfot.publlc;repott1ng{Jio(/filril$ •1d1iemeaiiing/utfor 48220 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices consumersand11Urchasers. SUl:t-aftedon 3.3 Measure setsft,rpaymenUncentllleprogmms,shouldamta/1'1 measuresfor •.V!flk.tl,~ts~t:td~~~~de~~usa.blllty·andusefiil~~'{f,te,te; For~Medfmrepoyment~ms; ffimlteretf.Ultestliat:m'!OslifesrtWst· su~ S.4 /Jrst$!11t1p{emenf!i:lll'lapublfttep(Jl'tfl'Jgprogtomt«a de~#atedpeffOdJ; AVdld~ofmeasunistltatfiriH/kelyto mitite.slgnfJk:anhidverse: ·~~l!flf!e'flc,/!S~~f1111.. sper:lflc.progNf!li so~ u tmp'i/as1te~of.~~res·tbQrh!NeeaiM'sflet:~ fMii/able: 4; Pfogl'tim m~setWiiiiidesan appttiJ:iriatem'ixoJmeasute types; P!lm01J~d•w..11.program1"-"1sure·settt.n,tl~es11.n•11.Ppro~ml!(.of.~; 11.~e, eiqierte11c1tofca~ ciist/tesoutte use/tq,p,qptfat.eiijss, tom~.atfdjtf(lctutalm~netessar,t,:,r tile spe#Jlcp(f)gNIJI ~ - 4,:.t in·g~t/ifefererwe.'sflouidtio~n ta medture CMIJi!s tbQt~'sllieti/lt progtaffl ~ . Sub-altelfon 4.1 Public reporting ofprogmmmeasuresetsshouldemphoslze outcames,thot ~ r t a . ~. lm:fi.i.cllngp@ep('•andcareg~r~~e~ • $ 1 ~ .«.S: P(IJtf!l~tpqtof!lm-ea.stl('eStttsslkJu)dfi:ldfJde:oqtcQf!lerneasu,-s<tnd:t'l>st• .measures ta ca~'iialllti.. s; Ptogl'tim measutesetenablts measurement ofperson" andfomiiy-atitetedcare.ttnd ~~$, Demonstratedlw.ap(f)gram.measuce·setthat·addressesaccess1 choke,.self-determlnatlon~and r;<>mmunlzy.f~(f)t/9rr ~ s.1 MjiisrJte stetQddrttssesJHifhmt'/ftlmltwcaregtverexfietltfnce;. lilcltidmJi aspeCU of.communk:atlon•andcacecoordlnatlon. ~~ $.I Me!lsl.ffeset~ssfl.~ddeclslOIJ f!IQklng. such asft!rca"Dl!d'S.I!~ pimmlngandesrobl.tslJtnr,Oflvanceef{~s; SU~~ Mjiisf,(fe~ttm,bfe$~ofthfffettsoil".Sa:ifecmi:lsiftvfi:es.(lr;rt.,$$ f:@vtdffl. m:tlhtis. tiridtlme, ~m ~ mgijj11~:$etftJc/f!(ieit:Qt1$f<ij(Qtl9f'ilMih:~¢9~ tl]s~~j ~tfcf ¢ultfll4l compefeney. P!lm~,!JWQ:P~l1'"1$.Uf;fl$.Btt#la.tpromq~~l!~#fflQ~S$01Jq~11fW•COIJ~ #1et.iftllcatel'/lsritt!itl.es. 'Fqctat$1h!iudf: adrltess.lflg ~•'°'(llc!ty,'s.Q®ffli(l~st!:Jtutla~~ gende'tj.seult1nentotlonr~ otgeogmt,hkaltottstdertitlons(e,g't iiibanvs. tutalJ. Prli9.itim measllie ~car, q/sQ addre5$popul@o~fltrlsl(/Qrll~dispar.ltle$ (e,g.;people. wftllbeluntlora.1/mem~ m;;,ssJ,. Su~ u Pri,gram.measuitfset.lfldudesmemurestt,atdllt!Ctly.ossess.hmlthmre dis~ (e.gv.#flf(ftpnitersrtt.vtQ/!s); VerDate Sep<11>2014 17:52 Aug 26, 2021 t.z Jkt 253001 ~m~ser/J'tdu~s~tlrat*"tse~tQ-tities miHJSutern@t(e.,g;,.~. bf~rtreattnentafter•d'heatt.attadcJ~ cmd'that PO 00000 Frm 00107 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.075</GPH> lotter on DSK11XQN23PROD with NOTICES1 $ii~ Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48221 far:1/ftatestt"Otf/katfon ofresults.tobetterundemondd(fferw,cesomong wfnemblepopulatlons, 7; ~tr:1m meQSUreset..PrQfllQ~pPrsimar,y qr,d'olignmen~ Oemonstfiitedbyaf,Jfajjfiim.measute·setthatsupfxirts.efffeleht.useoftesourcesftitdata,tolle«to'ita'itd ~~gCU1~~pp~c,//gnrnentocl'Q~~s.lJfe.Pl'QFt1.mrn~~·sfioqf#.,,alQllce.(he. ~~ c,ft:ffert~wltll1Jicto~eltf•~ft$qpp(H'f.U.nlt;f·to,lrtillff>WI qUCi/11:y;, lotter on DSK11XQN23PROD with NOTICES1 s i l ~ 1~ VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 ~mmeaswe setde~i:eseJlldemv(tie~ mlnliiiumiitimbetof ~u~·~the1e.r,,st..,,1,1~ens~rn~s•that~prpgrqm~fs); ~•rneqsure:setJ>l.or:esstl'Qn9,emplJ(lsls·c,tJ:meosf!t'lts··tfµ:ttcan~•used· ~multlp(e1)fograms.otaJ)IJllcat1on~ PO 00000 Frm 00108 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.076</GPH> S u ~ z1 48222 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Appendix E: MAP Structure, Members, Criteria for Service, and Rosters MAP operates through a two-tiered structu.re •. Guided by the priorities and goais of HHS' Natlonal Quallty Strategy, the MAP Coordinating Committee provides direction and direct Input to HHS. MAP's workgroups advls.e the Coordinating Committee on measures needed for specific care settings, care providers, and patient populatlons. Tlme-llmlted task forces .consider more focused topics, such as developing "famllles of measures"-related measures that cross settings and populations-and provide further Information to the MAP Coordinating Committee and workgroups. Each multlstakeholdei' group Includes lndlvlduals with content expertise and organizations partlcularly affected by the work. MAP's members are selected based on NQF's Board-adopted selectlon criteria through an annual nominations process and an open publlc commenting period. Balance among stakeholder groups Is paramount. Due to the complexity of MAP's tasks, Individual subject matter experts are Included In the groups. Federal government ex officio members are non-voting because federal officials cannot advise themselves. MAP members serve staggered three-year terms. Committee Co-Chairs (voting) 8l'Uce Hall, MD, Pho BJC Healthcare Charin Kahn, II~ MPH MAP Rural Health Wortcaroup Members Federation of American Hospitals committee co~chalrs (voting) Organizational Members (voting) · Aaron Garman, MD Coal Country Community Health America's Health triturance Plans. American Collt11 of Phvslclans American Health Care Association American Hospital AQoclatton American Medical AHOcllltlon American Nursu Atsoc:llltlOn Health CaN Servtm Corporation ffumana The JOlntCommlSJlon The I.Hpfrot Group Medicare Rights center National Business Group on Health National Committee for Quality Atsuranca National Patient Advocate. foundation N8'Mlrlc for Rqlonal Healthcare· Improvement Pacific suslnaSI Group on Health Patient a Famlly Centered Cara Parm.rs Center Individual Subject Matter Experts (voting) HaroldPlncm, MD Jeff Schiff, MD, MBA Ron Walters, MD, MIA, MHA. Federal Government Liaisons (non-voting) A&lnty for HHlthcare Reieareh and lotter on DSK11XQN23PROD with NOTICES1 Quality (AHRQ) canters for Dlsn• Control and PNVlntlon (CDC) centers for Madlclra a Madlcald Sen,lcas (CMS) VerDate Sep<11>2014 Office of the National Coordinator fOr Hilallh Information Tac:hnololY (ONC) 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Individual Subject Matter experts (voting) Mlchaal Faddan, MD John Gale, MS Cllrtllllowery, MD Malinda Murphy, RN, MS Jessica Schumacher, PhD Ana Verzona, MS, APRN, FNP, CNM HollyWolff,MHA Federal Government Liaisons (non-voting) federal OfflCll of Rural Holth Polley, Ira MOICOYICI, PhD University of Minnesota School of Public Health Org;inizational Members (voting) Alliant Health Solutions · Amerlain Academy of Famlly Physicians (AAFPI Amerlain Acadal'!IY of Physl~n Assistants (A.APA) American eou,11 of Em•'1i•IICY Phvslclans (ACEP) American Hospital AssOdatlon (AHA) American SOclaty of HHlth-SVStem Pharmacists (ASHP) Clrdlnal lnnovatlolil GelSlnpr Health lntermountaln Hialthcaie Mlch'8111 Centar for Rllral Health Minnesota Community Manurement National Anodatlon of Rural Health Cllnk:t (NARHC) National Rural HHlth Association (NilffA) National Rural latter Carlfers• Assodatlon INRI.CA) RUPRI Center fOr Rural Health Poley Analysis Rural WfllconSln Health Cooperative (RWHC) Truven Haalth Analytlct U.C/IBM Watson Ha■lth Company Frm 00109 Fmt 4703 Sfmt 4725 DHHS/ffllSA Center for Medicare 1nd Medicaid Innovation,. Centers tor MedlCllra a Medicaid Slrvloas (CMS) lndlan Health Slrvloas, DHH ·MAP Cllnlclan Wortcaroup Members Committee Co-Chairs (voting) Bruca Balllay, MD organizational Members (voting) The Alllanoa Amarlca's Physician Groups American Acadlmy of Family Physicians American Acadlmy of Pediatrics American Association of Nur:se PftetltlOnll:t Amarlcan Collap of Cardlofol'/ American Collap of Radtotocv Amarlcan Occupatlonal Therapy Anocllltlon Anthem AtrlumHHlth Consumers' Chedcbool!/Ctiilter for the Study of Sll'VIOIS CouncR of Medical Spacllllty SocletllS Genantecih ffHlthPlrtn!III, Inc. Kallltr Perm1111nte E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.077</GPH> MAP Coordlnatln1 Committee Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices FOundatlon ICuttMmllilt;MD Compassus Mapllanffa!!ltti; into N~~nl!f~ (NAACOSI GruterN-Yol'k·._pJtlll =~~P,tmary~ auslMisGroup• Htatth PiltlentMtyAd!Oii N~l'lc St. LoulsANa ausJMSs Hullh Coalltton l!idlvldinllSub,iec;t Matter: Experts(wting) Nlihliit "Slrlilii"Aiiliild Wilhlllt Flelichmari Qliilyds Patltft!Clt~Rf Oi'ganlzational Members Alsc!ClltlOn. (voting) AMDA-TheSod!lt,for.PDst-Acute . tttnrvfONI ~·sv-ms· National Anodadon. tor 8ehavklrat HhlthellNI ~ Nltkinal Assodadon of Plydilatrlc Hulth• ~Qllliilty Alllllllclt .~Gilllf PrOjtct.Padent c:ar. ... Clllmlrs for MedrcaN.& Mlaiellild Sllrvlclu (CMS) Hllalth R_,urmsand Slll'iilcles Mmlnlsnlllln IHRMI MAP Hospital W~P Members committee CO'Chairs (votill&) R. S..nlVIOrri.on NatlDllal toalitionfor Hospjceand Pallhltlve Care Ci'Mle Upshaw Travis, N$Hl'IA. Memphl$ BUslne$$GrO!IP on Heaitlt Organizationa1·Membets (voting) Amerlca's·Esselmii•·llosllbis; Amerk:ln Assoclltlo!ll!f ICldliey Patients Amei'lailt C.•illlii!liilt\Mnt• AtsoclMlon Amel'lcan$odltyol' Aneitheslo!ollsts. Amel'lcan Holpltlll ~ Jkt 253001 Medld!le a.nd · R._b~ (AAl'Ml!RI IVIOtliersAll!Mtllt'lii!ilcalErrcil: Federal GovernmentUalsons 17:52 Aug 26, 2021 AmlrlcanAcademyol'Physlelil MidtninJo,Nlnlinallf l!Wiililw 'llitl'llflY Group Moll!ll flealthtaie (n~n-votlng} OlntersforDlseaa COntrol anci ,,_.... ICl>i:I .andlill'ilt-Ttirm<ft. ~ lntermolllltllnHulthca.ra PO 00000 Amllrbn Gtirlatm:s.Socley. AmllrbnOCtllpatkinalTl\mjiy AssodatfDn Amtl'.fclrl physk:alThenapy AssodatfDn Celite1111COrponidon .SWtllMI stephanle.i=ry lotter on DSK11XQN23PROD with NOTICES1 Ar1zon11StateUntversltv COl!qu City al' Hope Plldflc VerDate Sep<11>2014 Alsc!ClltlOn ol'.Amerlclln Medlcll lCl!ldml HhlthellNI Premllr,lnc.. l.qlilCOUl!lllffortlMIElr:ltirly Nlltklnlll and P i ~ .ClNQrpnll8tkln ._,lea SlrvkaE~~I UnlOn Natklnal ~ OkarAdirl'sory 5oc1etyfor Mlllllmal:;tetali'iiiadk:iita 1,1Pllo1Cttwlll'lln Pilntil. NatklnalTrllliltlonsol'ara .COlllltklll '!liltlns,._.~•Of l11clivlcltial. Subject Matter EXp~i'l:s ('ioting) America Aiidrffa Ball...cohiil; Pf!O lrldlvldualSubjecfMatter IJilclsly.Wfillani Federal <acm,mment Liaisons ~ (.voting) Sarah Llvuay, DNP,M, AcNP.liC, (110/i"lll)tlng} . . .· . . A(entyforlfealthtareRUUl'diliilcl QusilliY (AHRQI CNS« Cintenfor .DlllliHCoritrcililnd PreWfltlOn (CDC) Cintenfof lllladlciire&,.,...lil $el'iilcles (CMSt MAP Post;_Actlte Care/long-Term Care Workgfoup Committee Co-Chairs (votiii&) Gtl'.11 l.liinb, PliO Frm 00110 Fmt 4703 Sfmt 4725 Ralil""8ftll'lllll,Nll$ l'ilul.Mu1'1ausan, Nii> ~Nlltdo,.Pl!D Amish trlwd~Pllafflli> Federal GovemmenfLlaisons (non-yQtinlll Ctilitatfor DlaaaCOntrok-.ci !'NIVentlcin.(CDCl Cintenfot Mldlcl!~&Mtclicikl Servlce$(CM$} •Offlal Of tlilt NlltklnlllC'oontlrini!' for Htiahh lnformadon Tiltlln<llo&Y (ONC) E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.078</GPH> LoulH. Batz Patient. Safety 48223 48224 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Appendix F: federal Quality Reporting and Performance-Based Payment Programs COIJstdered by MAP 1. Ambulatorv Surgical center O.Uallty RepQrttng Program: 2. End~staae Renal Disease Quality Improvement.Program 3. Home Health Q.uallty ~eportfng Program 4. Hospice Quality Reporting Program 5. Hospltal;.,i\cqurredCondttIon ReducUon Program 6. Hospttal lripatlento.uallty Reporttrig Program arid Medicare arid Medicaid Promoting lnteroperablllty Program.for.E!JglbleHospltllls and Critical Access Hospitals 7. HospltalOutpatlentO.Uallty Reporting Program 8. Hospital Readmissions ReducUon Program 9. Hospital Value-Based Pul"Chaslng Program 10. inpatient P$YChlatl'lc FacliltY a:ualltY Reporting Progl'.cim U •• Inpatient Rehabtntatlon Factllty 0.u,dlty Reporting Program 12. Lori1flerm:care·HospltaI a.uallty Reporting Prograht 13, Medlc:are Shared Savings Program 14. Merit-Based lriceritlve PaymeritSystem 15, F!ro$pectlve Pay~nt System ExE!mpttancer j,(QllpltatQ.ualttvReportlng 16. Skllled Nursing Facility' auanty Reportrng Program. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00111 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.079</GPH> lotter on DSK11XQN23PROD with NOTICES1 11:Skiliec:fNur:sfng Faclilty Value-Based Purchasing Program Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48225 VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00112 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.080</GPH> lotter on DSK11XQN23PROD with NOTICES1 Appendix G: Identified Ciaps by NQF NleasurePortfolio The Identification of measutegaps.wlthln the N0.Ftoplc areas Is a process that .allows Standing Committees to brainstorm and 1dent1tywhere hlih value measutes.aretoofew or nonexistent.to.drive lmprove1T1ent. The measurement gaps ldentlfled aero$$ all portfoltos are shared below: • Measures thatfo~s e>n dlsp11rlttes and social d~rl'l'llhants of health (e;g., adeqt1ate ho!JSlns. employment, and transportation) • Measures focused on care coord1nat1on atrosstite llfe span • Measijf85.rotusecfon the pediatr!t population and neurolcgital cond1t11:>ns.(e;g,; sttOke performance and care, e1T1ergency response, long-'terlTI fUnctlonafoutco!Tles( sen,lces utlllzatlon on a tbmmunlfy level, pbst-acute care, and rehabltitatlOh) • Measures focused on the:conslderation of physical and octupationa[therapy as lt reliiteS to neurolt,glcal Cbndrtlons • Meast1res·tocusedon perlhata}and women's healtt,{e,g,, lntlmate.partnervlolence,•postpartum depressfbn, arid careglverburden) • Mea:sures that focus on provider "burnout"; lncludnigthose tied to payer-managed tare (e.g,, prior authorization; treatment llmlts) • Measures thatf~us on c;are1ntegratlc)nbetween !Tlentlll heall:h; st1bstanceusedlsorder:s, and phystcar heatth{e~•• primary care) 48226 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices Appendix H: Medicare Measure Gaps Identified by NQF's Measure Applications Partnership MAP Clinician Worqroup Within the Merlt"Based Incentive Payment System (MIPS) measure set, MAP Identified several gaps, speclflcally In the areas of primary care, access, continuity, comprehension, and care coordination. MAP also suggested that CMS consider adding measures that d.etermlne whether a course of therapy Is Indeed the best for the patient to optimize reduc;tlons In cost and harm. MAP also emphasized measures of diagnostic accuracy and primary care PROMs. MAP Identified several measure gaps within the Shared Savings Program: diagnostic efficiency, measures of cultural change, and addltlonal measures of care coordination and handoffs using eCQMs. MAP discussed measure gaps associated with the Medicare Part C and D Star Ratings and suggested that C:MS add measures of access to .provider networks, PROMs related to functional status, and care coordination within care transitions. MAP expressed cOhcem that the medication adherenc;e measures do not capture rational non-adherence and patient.preference, and also. 11uggested the removal of older process measures, such as diabetes screening, In favor of measures that beneficiaries might find more useful when selecting a plan, such as out-of-pocket cost. MAP also suggested the Inclusion oftelehealth Into existing measures. MAP Hospital Workaroup In consideration of measure gaps, MAP noted that all of the End-Stage Renal Disease (ESRD) Quality Improvement Program (QIP) patient experience measures are composites, and MAP suggested that InCenter Hemodlalysls (ICH) CAHPS questlbns could be broken out and reported separately. MAP also called on CMS to consider how to Include more specific patient safety measures beyond the generic question Included In CAHPS as well as functional status and quality of life measures, especially given the slated changes In payment policy related to dialysis coverage through Medicare Advanta,e. MAP suggested the Hospital Inpatient Quality Reporting (IQR) program would benefit from additional care transitions measures as well as enhanced measures of preventable healthcare harm, such as the PSI 90 composite (NQF #0531) •. MAP encouraged the development of Medicare spending per beneficiary measures for conditions that align with CMS mortality and readmission measures. MAP also stressed that the program would benefit from additional patient safety measures as well as measures on engagement of patients and famllles and transfer of Information across care settings. MAP suggested that CMS Identify measurement priorities for patient populations within units for Inpatient psychiatric facmttes, speclflcally geriatric units for Inpatient Psychiatric Faclllty Quallty Reporting {IPFQR). VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00113 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.081</GPH> lotter on DSK11XQN23PROD with NOTICES1 MAP noted a gap In measures within Prospective Payment System Exempt cancer Hospital Quality Reporting (PCHQR) regarding PROs for functional outcomes and quality of life, access to care, and survival. It was also noted that measures are needed to. ensure smooth transitions between care settings, especially hospice. MAP also noted the need for measures that encourage the move from standardized approaches within cancer care to Increased adoption of personalized medicine and pharmacogenomlc testing. MAP encouraged CMS to continue partnerships with existing cancer registries to. gather data for future measurement. Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48227 MAP did notevaluate any measures for Ambulatory Surgical ~nter Quality Reporting (AS~l during this MAP cycle, but theysugested lnfectton'-!'t!lated measure11,metr1cs that establ!Sh the quality and safety of procedures within ambulatory .surgery.centers previously done In ·hospltartnpatlentand outpatlent settings, .medication.safety measures wlthan emphasis on.opioid prescrlbfngand stewardshlp,ahd measures of PROswlth an emphaslsoi1funct1on11 status. there wete. l't() measures for consldi!ratlonfortheMAP during this cycliffor the Hosp1tarA1:qultet:f condition (HAC) program. MAPdtd not Identify any specific measure gaps but rncludedcommerrts related to the tlsk adjustment model for the tfACquallty measure, Speclftcally, MAP noted concem that the rtskadJustment modermay unfairly l>i!nall:ze hosl:lltais tfiatnaw mc,re tellabtetesults by usl!ll thi! national average to Impute the hospltalscore for those with smaller case volume. It was also mentioned that a naloxone prescription Is not always an Indicator thatthere has been harm but may be appropriate tor prestrlbl!ll, the'2019 Muc 11st did not 1:ontatrtany potentlal ttospttal Readmissions :Redui:tlort Pr:cgram(HRRP) measutesfofMAPto. review; In the dllicussron of gapsforthls measute set,. MAP suggestedevatuatrhJ seven-day readrriissJon ra~ ra~h~ than 30-ciayrates. MAP suffl$dJh;tt there1,1c1s an Issue Yllth atttlbut1on,namely that.30.;day measures may not solely reflect the perforh'iance of the hosl)ltal, but a combination ofhospltal and community care; MAP noted thatsome.ofthe measures have been In the program for a longtime and may haveJQpped out. They c:alled ori CMS to examlne Whtch measures may have outlived their usefulness. MAP also encouraged CMS to explote the poter1t1a1 lnterattron betw.een mortality and readmissions, particularly for patients with heart failure; TheteWere no measures underc:oristc:terat1oriJor Hospttar Outpatient QUallty Repo'ttlhg {OQ.R) this cycle. MAP did notspeclfy any ml!asuregapsfor the program du('fng~elr cllscusslon. Hospital \talue~Based Payment(VBI>) had 110 measures forconslderat:lon during this cycle. In MAP dlalogueon measure pps,rtwas !'IC)ted thatHospTtalVBPisasubset ofldR measures. MAP sumsted the IQR program WC>uld benefit from addlttohal c:atetrarisltlohs measures as Well as ehhancec:t measures ofpreventable healthcare harm~ such as the PSI-SO compQslte (NQ,F #0531). ·MAP also emphasized makrn,measutes !'1'101"!!' attJortablefotHosplta[V8P, such as. by rep0rtllig CAHPS:scotes by UhlUtid by reporting Medicare spending perbeneflc:lary for cohdltlonsthat match CMS. mortallty.ahd readl'l'ilsslori measures. MAP Identified potential gaps fn the Home Health Quality Reporting Program {HK QRP) measure set. MAI> members Identified measurementgaps aroun(l long-term tracklng of actMtles of dally llvlng and measurement that captuteSwound cate hollStlc:ally. In Its review of the H05plc:e O.uality Rept>rtlng Program measuteset, l\llAP rioted a pp lri measures addtesstngsatety, partrc:ularlyaround polypharmacyand med1c:at1on.reconc111at1on;PR0s.around· liYl'FIPtom.manageml!n~; care aligned wtththl! patient's goals; anci communication of those.goals to th!l next site of care should the patient leave. hospice. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00114 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.082</GPH> lotter on DSK11XQN23PROD with NOTICES1 the Inpatient Rehabllltatton FacllltyQ.uallty Reporting Program (IRF Q.RP)dld. not have any measures submitted for tevlew durrng this cycle•.MAP noted appropriate clln1ca1 presc:rlblng:arid use of oi:,lotdsas a potential ml!asurementgap In the Hf QRP measure set, 48228 Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices There were no measures su~mltted for rev~w for the Long-Term care Hospital Quc[lllty Reporting Program {LTCH QRJ>) c:rurtngthis cycle. MAP Identified the avanablllty of palllatrve care as a measure gap for l TCH QRP. While MAP did not have any measures submtttedJor teVtew fol"'SkllledN:urstngFaclltty Quality Reporting Program (SNFQRJl)durlngthls cycle, the group engaged lrta robust dlscusston of measure gaps. MAP Identified bldlrectlonal transfer of lnfQrmation1-quallty andsiilfety of cal'E!ttansltton$, patient and family enga~rnent; and careallgried with .patients' goals as measul'E! gaps 1n the program. They noted that the transfer of Information should be robust and thaf measures rteed to encompass thequalltyof the 1n:format1on transferred, n:otJustthat atran$lertook place. They also stressed that ace1.1raey.of. mediation llstsand medication reconcllfatton Is a key element In the quality and safety ofcare transitions. VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00115 Fmt 4703 Sfmt 4725 E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.083</GPH> lotter on DSK11XQN23PROD with NOTICES1 t.r1A~dld not have arty meas.Ur$$ submltted t'QrrevlewfortheSklllec(Nurslng. Fildl!ty Value~Based PUrchilslng {SNFVBP) Program during this.eycte. MAP •lso did not discuss any gaps fotthe SNF VBP program; Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Notices 48229 Appendix I: Statutory Requirement of Annual Report Components As amended by the above laws, the Social Security Act (the Act}-specl/lcal/y section 1890{b)(S){A)mandates that the entity report to Congress and the Secretary of the Department of Health and Human services (HHS) no later than March 1st of each year. The report must Include descriptions of: • • • • • • how NQF has Implemented quality. and efficiency measurement Initiatives under the Act and coordinated these Initiatives with those Implemented by other payers; NQF's recommendations with respect to an Integrated national strategy and priorities for healthcare performance measurement In all applicable settings; NQF's performance of the duties required under Its contract with HHS (Appendix A}: gaps In endorsed quallty and efficiency measures, Including measures that are within priority areas Identified by the Secretary. under HHS' national strategy, and where quality and efficiency measures are unavailable or Inadequate to Identify or address such gaps; areas In which evidence Is lnsu/ftclent to support endorsement of measures In priority areas Identified by the National auallty Strategy, and where targeted research may address such gaps; matters related to convening multlstakeholder groups to provide Input on: a) the selection of certain quality and efficiency measures, and b) national priorities fr,r Improvement In population health and In the delivery of healthcare services fr,t conslderl:Jtlon under the National Quality Strategy;.(Throughout This Report, the Relevant Statutory Language Appears In ltallc/1ed Text., n.d.) an lteml1atlon off/npncial tnfr,rmotlon fer the /lscol year ending September 30 of the preceding year, fnc/µdlng: (I) onnua/ revenues of the entity (Including ony government funding, private sector contributions, grontS, membership revenues, ond Investment revenue); {II) annuol expenses of the entity (lnc/ud/ng.grantS paid, benefits paid, salaries or other compensotlon, fundralslng expenses, ond overhead casts}; and (Ill) a breakdown of the amount awarded per contracted task order and the specific projects funded In each task order assigned to the entity; and • any updates or modifications of Internal po/le/es and procedures of the entity as they relate to the duties of the entity under this section, Including: {I) speclflcal/y Identifying any modifications to the disclosure of Interests and conflicts of Interests fr,r committees, work groups, task fetces, and advisory panels of the entity; and (II) lnfr,tmatlon on external stakeholder participation In the duties of the entity under this.section (Including complete rosters fer all committees, work groups, tosk forces, and advisory panels funded through government contracts, descriptions of relevant Interests and any conflicts of Interest fer members.of al/committees, work groups, task fr,rces, and advisory panels, and the total percentage by health care sector of all convened committees, work groups, task ferces, and advisory panels, [FR Doc. 2021–18485 Filed 8–26–21; 8:45 am] BILLING CODE 4150–28–C DEPARTMENT OF HEALTH AND HUMAN SERVICES lotter on DSK11XQN23PROD with NOTICES1 National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Sep<11>2014 17:52 Aug 26, 2021 Jkt 253001 PO 00000 Frm 00116 Fmt 4703 Sfmt 4703 amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning E:\FR\FM\27AUN1.SGM 27AUN1 EN27AU21.084</GPH> •

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 86, Number 164 (Friday, August 27, 2021)]
[Notices]
[Pages 48154-48229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18485]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[CMS-3402-N]


Secretarial Review and Publication of the 2020 Annual Report to 
Congress and the Secretary Submitted by the Consensus-Based Entity 
Regarding Performance Measurement

AGENCY: Office of the Secretary, Health and Human Services, (HHS).

ACTION: Notice.

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SUMMARY:
    This notice acknowledges the Secretary of the Department of Health 
and Human Services (the Secretary) receipt and review of the National 
Quality Forum 2020 Annual Activities Report to Congress and the 
Secretary submitted by the consensus-based entity (CBE) under a 
contract with the Secretary as mandated by the Social Security Act (the 
Act). The Secretary has reviewed and determined that the National 
Quality Forum's 2020 Annual Report satisfied all requirements mandated 
in statute, and is publishing the report in the Federal Register 
together with the Secretary's comments on the report not later than 6 
months after receiving the report in accordance with section 
1890(b)(5)(B) of the Act. This notice fulfills the statutory 
requirements.

FOR FURTHER INFORMATION CONTACT: LaWanda Burwell, (410) 294-2056.

I. Background

    The United States Department of Health and Human Services (HHS) has 
long recognized that a high functioning health care system that 
provides higher quality care requires accurate, valid, and reliable 
measurement of quality and efficiency. The Medicare Improvements for 
Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275) added 
section 1890 of the Social Security Act (the Act), which requires the 
Secretary of HHS (the Secretary) to contract with a consensus based 
entity (CBE) to perform multiple duties to help improve performance 
measurement. Section 3014 of the Patient Protection and Affordable Care 
Act (the Affordable Care Act) (Pub. L. 111-148) expanded the duties of 
the CBE to help in the identification of gaps in available measures and 
to improve the selection of measures used in health care programs. The 
Secretary extends his appreciation to the CBE in their partnership for 
the fulfillment of these statutory requirements.
    In January 2009, a competitive contract was awarded by HHS to the 
National Quality Forum (NQF) to fulfill requirements of section 1890 of 
the Act. A second, multi-year contract was awarded again to NQF after 
an open competition in 2012. A third, multi-contract was awarded again 
to NQF after an open competition in 2017. Section 1890(b) of the Act 
requires the following:
    Priority Setting Process: Formulation of a National Strategy and 
Priorities for Health Care Performance Measurement. The CBE must 
synthesize evidence and convene key stakeholders to make 
recommendations on an integrated national strategy and priorities for 
health care performance measurement in all applicable settings. In 
doing so, the CBE must give priority to measures that: (1) Address the 
health care provided to patients with prevalent, high-cost chronic 
diseases; (2) have the greatest potential for improving quality, 
efficiency, and patient-centered health care; and (3) may be 
implemented rapidly due to existing evidence, standards of care, or 
other reasons. In addition, the CBE must take into account measures 
that: (1) May assist consumers and patients in making informed health 
care decisions; (2) address health disparities across groups and areas; 
and (3) address the continuum of care furnished by multiple providers 
or practitioners across multiple settings.
    Endorsement of Measures: The CBE must provide for the endorsement 
of standardized health care performance measures. This process must 
consider whether measures are evidence-based,

[[Page 48155]]

reliable, valid, verifiable, relevant to enhanced health outcomes, 
actionable at the caregiver level, feasible to collect and report, 
responsive to variations in patient characteristics such as health 
status, language capabilities, race or ethnicity, and income level and 
are consistent across types of health care providers, including 
hospitals and physicians.
    Maintenance of CBE Endorsed Measures: The CBE is required to 
establish and implement a process to ensure that endorsed measures are 
updated (or retired if obsolete) as new evidence is developed.
    Convening Multi-Stakeholder Groups. The CBE must convene multi-
stakeholder groups to provide input on: (1) The selection of certain 
categories of quality and efficiency measures, from among such measures 
that have been endorsed by the entity and from among such measures that 
have not been considered for endorsement by such entity but are used or 
proposed to be used by the Secretary for the collection or reporting of 
quality and efficiency measures; and (2) national priorities for 
improvement in population health and in the delivery of health care 
services for consideration under the national strategy. The CBE 
provides input on measures for use in certain specific Medicare 
programs, for use in programs that report performance information to 
the public, and for use in health care programs that are not included 
under the Act. The multi-stakeholder groups provide input on quality 
and efficiency measures for various federal health care quality 
reporting and quality improvement programs including those that address 
certain Medicare services provided through hospices, ambulatory 
surgical centers, hospital inpatient and outpatient facilities, 
physician offices, cancer hospitals, end stage renal disease (ESRD) 
facilities, inpatient rehabilitation facilities, long-term care 
hospitals, psychiatric hospitals, and home health care programs.
    Transmission of Multi-Stakeholder Input. Not later than February 1 
of each year, the CBE must transmit to the Secretary the input of 
multi-stakeholder groups.
    Annual Report to Congress and the Secretary. Not later than March 1 
of each year, the CBE is required to submit to the Congress and the 
Secretary an annual report. The report is to describe:
     The implementation of quality and efficiency measurement 
initiatives and the coordination of such initiatives with quality and 
efficiency initiatives implemented by other payers;
     Recommendations on an integrated national strategy and 
priorities for health care performance measurement;
     Performance of the CBE's duties required under its 
contract with the Secretary;
     Gaps in endorsed quality and efficiency measures, 
including measures that are within priority areas identified by the 
Secretary under the national strategy established under section 399HH 
of the Public Health Service Act (National Quality Strategy), and where 
quality and efficiency measures are unavailable or inadequate to 
identify or address such gaps;
     Areas in which evidence is insufficient to support 
endorsement of quality and efficiency measures in priority areas 
identified by the Secretary under the National Quality Strategy, and 
where targeted research may address such gaps; and
     The convening of multi-stakeholder groups to provide input 
on: (1) The selection of quality and efficiency measures from among 
such measures that have been endorsed by the CBE and such measures that 
have not been considered for endorsement by the CBE but are used or 
proposed to be used by the Secretary for the collection or reporting of 
quality and efficiency measures; and (2) national priorities for 
improvement in population health and the delivery of health care 
services for consideration under the National Quality Strategy.
    Section 50206(c)(1) of the Bipartisan Budget Act of 2018 (Pub. L. 
115-123) amended section 1890(b)(5)(A) of the Act to require the CBE's 
annual report to the Congress include the following: (1) An itemization 
of financial information for the previous fiscal year ending September 
30th, including annual revenues of the entity, annual expenses of the 
entity, and a breakdown of the amount awarded per contracted task order 
and the specific projects funded in each task order assigned to the 
entity; and (2) any updates or modifications to internal policies and 
procedures of the entity as they relate to the duties of the CBE 
including specifically identifying any modifications to the disclosure 
of interests and conflicts of interests for committees, work groups, 
task forces, and advisory panels of the entity, and information on 
external stakeholder participation in the duties of the entity.
    The statutory requirements for the CBE to annually report to the 
Congress and the Secretary also specify that the Secretary must review 
and publish the CBE's annual report in the Federal Register, together 
with any comments of the Secretary on the report, not later than 6 
months after it has been received.
    This Federal Register notice complies with the statutory 
requirement for Secretarial review and publication of the CBE's annual 
report. NQF submitted a report on its 2020 activities to the Congress 
and the Secretary on March 1, 2020. The Secretary's Comments on this 
report are presented in section II. of this notice, and the National 
Quality Forum 2020 Activities Report to the Congress and the Secretary 
is provided, as submitted to HHS, in the addendum to this Federal 
Register notice in section III.

II. Secretarial Comments on the National Quality Forum 2020 Activities: 
Report to Congress and the Secretary of the Department of Health and 
Human Services

    Once again, we thank the NQF and the many stakeholders who 
participate in NQF projects for helping to advance the science and 
utility of health care quality measurement. Access to care, quality, 
and health outcomes took on a new urgency in 2020 as the COVID-19 
Public Health Emergency (PHE) emerged, surged, and persisted across the 
United States. As the COVID-19 PHE endured, The Centers for Medicare 
and Medicaid Services (CMS) coordinated with NQF to ensure that measure 
endorsement and maintenance reviews did not stand in the way of 
frontline clinicians' life-saving efforts. Measure review meetings 
originally scheduled for spring and summer of 2020 were re-convened 
later in the year and all meetings became virtual. These changes aimed 
at freeing up the schedules of frontline clinicians on the Standing 
Committees so that they could prioritize for the COVID-19 PHE. The 
dedication of the NQF Standing Committees and agility of NQF's staff 
played a crucial role in maintaining a strong portfolio of endorsed 
measures for use across varied providers, settings of care, and health 
conditions. NQF reports that in 2020, it updated its measure portfolio 
by reviewing 84 measures and endorsing 65. Endorsed measures address a 
wide range of health care topics relevant to HHS programs, including: 
person- and family-centered care; care coordination; palliative and 
end-of-life care; cardiovascular care; behavioral health; pulmonary/
critical care; perinatal care; cancer treatment; patient safety; and 
cost and resource use.
    In addition to maintaining measures endorsement, NQF worked to 
remove measures from the portfolio for a variety of reasons (for 
example, measures no longer meeting endorsement criteria;

[[Page 48156]]

harmonization between similar measures; replacement of outdated 
measures with improved measures; and lack of continued need for 
measures where providers consistently perform at the highest level). 
This continuous refinement of the measures portfolio through the 
measures maintenance process ensures that quality measures remain 
aligned with current field practices and health care goals. Measure set 
refinements also align with the HHS initiatives, such as the Meaningful 
Measures Framework at CMS. CMS is working to identify the highest 
priorities for quality measurement and improvement and promote patient-
centered, outcome-based measures that are meaningful to patients and 
clinicians.
    Throughout 2020, NQF continued the important work of building 
consensus from stakeholders on strategies to leverage quality 
measurement to improve health outcomes. The COVID-19 PHE has glaringly 
exposed and exacerbated pre-existing health care 
disparities.^{1 2} Social determinants of health (SDoH) are 
crucial factors in health outcomes, and significant health disparities 
persist. The COVID-19 PHE has further illustrated longstanding health 
inequities with higher rates of infection, hospitalizations, and 
mortality among black, Latino, and Indigenous and Native American 
persons relative to white persons. Equity is not a new challenge, but 
despite past efforts, disenfranchised groups continue to experience 
worse health outcomes. Providing the highest quality of care is only 
possible, if we deliver equitable care.
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    \1\ Zelner, J., R. Trangucci, and R. Naraharisetti, et al 
(November 21, 2020). Racial Disparities in Coronavirus Disease 2019 
(COVID-19) Mortality are Driven by Unequal Infection Risks. Clinical 
Infectious diseases, claa1723. https://doi.org/10.1093/cid/ciaa1723
    \2\ Ortiz, N., and D. Flamini (May 1, 2020) Does COVID-19 
discriminate? Experts Discuss Pandemic's Effect on Minority Groups. 
(https://www.nbcmiami.com/news/local/does-covid-19-discriminate-experts-discuss-pandemics-effect-on-minority-groups/2227096/, 
accessed 2/24/2021).
---------------------------------------------------------------------------

    CMS strives to understand and address repercussions of the COVID-19 
PHE on disparities. CMS has continued to leverage its partnership with 
NQF, recognizing NQF's unique role as a CBE and its experience 
developing multi-stakeholder consensus. In 2020, CMS funded a project 
that focuses on quality measures for assessing the impact of telehealth 
on rural health care system readiness and disaster-related health 
outcomes. Another new project focuses on best practices for functional 
and social risk adjustment, including potential data sources other than 
those currently used by developers. CMS also funded a new project on 
quality measures that could encourage collaboration between the health 
care and non-health care sectors, like social work, public safety, and 
criminal justice to combat polysubstance use among opioid users with 
behavioral health conditions.
    NQF also continued to carry out several CMS-funded projects awarded 
before 2020 for which health equity is front and center (for example, 
the Maternal Morbidity and Mortality project and the Social Risk Trial 
to galvanize stakeholders' efforts to reduce disparities by closing the 
performance gap.
    Facilitating health equity across settings and payers is just some 
of many areas in which NQF partners with HHS to enhance and protect the 
health and well-being of all Americans. Meaningful quality measurement 
is essential to the success of value-based purchasing, as evidenced in 
many of the targeted projects that NQF is being asked to undertake. HHS 
greatly appreciates the ability to bring many and diverse stakeholders 
to the table to unleash innovation for quality measurement as a key 
component to value-based transformation. We look forward to continued 
strong partnership with the NQF in this ongoing endeavor.

III. Collection of Information Requirements

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

    Dated: August 23, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
BILLING CODE 4150-28-P

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[FR Doc. 2021-18485 Filed 8-26-21; 8:45 am]
BILLING CODE 4150-28-C

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