Secretarial Review and Publication of the 2019 Annual Report to Congress and the Secretary Submitted by the Consensus-Based Entity Regarding Performance Measurement, 60175-60245 [2020-21103]

Download as PDF Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices measures, along with the additional control measures provided in the Guides. The process for seeking such recognition is identified in the Administrative Arrangement between the United States Food and Drug Administration and the DirectorateGeneral for Health and Food Safety of the European Commission Regarding Trade in Bivalve Molluscan Shellfish (Ref. 9). In the future, FDA will publish in the Federal Register any proposal to recognize additional EU Member States as equivalent and accept comments on the proposal before finalizing the Agency’s determination. Regarding the maintenance of equivalence, both FDA and the EC will carry out periodic onsite evaluations or audits to ensure that equivalence is maintained. In addition, the EC will notify FDA of any plan to adopt, modify or repeal a food safety control measure applicable to molluscan shellfish so that FDA can determine whether the new, modified or repealed measure affects its equivalence determination (Ref. 9). After considering the comments, we are finalizing the equivalence determination for Spain and the Netherlands. II. Equivalence Determination We are announcing that we recognize the adoption and implementation by Spain and the Netherlands of the EU system of food safety control measures for raw bivalve molluscan shellfish, along with their application of additional control measures described in the Guides, as equivalent because the adoption and implementation of these measures by Spain and the Netherlands provide at least the same level of sanitary protection as comparable food safety measures in the United States (19 U.S.C. 2578a(a)). Because FDA recognizes these control measures have been successfully adopted and implemented by Spain and the Netherlands, this final equivalence determination allows FDA, the competent authorities in Spain and the Netherlands, and the EC to implement procedures for resuming trade in accordance with the final equivalence determination. For the export of raw bivalve shellfish from Spain and the Netherlands to the United States, these procedures include the subsequent listing of eligible establishments in Spain and the Netherlands on the ICSSL once the EC has been notified of our final equivalence determination. III. References The following references are on display at the Dockets Management Staff (HFA–305), Food and Drug VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https:// www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish. Food and Drug Administration and Interstate Shellfish Sanitation Conference. 2007 through 2017 revisions (web page last updated October 2018). Accessed online at https://www.fda.gov/food/ guidanceregulation/ federalstatefoodprograms/ ucm2006754.htm. 2. ‘‘Community Guide to the Principles of Good Practice for the Microbiological Classification and Monitoring of Bivalve Mollusc Production and Relaying Areas with Regard to Regulation 854/2004.’’ European Commission. June 2012, updated January 2014 and January 2017. Accessed online at https://ec.europa.eu/ food/sites/food/files/safety/docs/ biosafety_fh_guidance_community_ guide_bivalve_mollusc_monitoring_ en.pdf. 3. ‘‘Microbiological Monitoring of Bivalve Mollusc Harvesting Areas Guide to Good Practice: Technical Application (Technical Application Guide).’’ EU Working Group on the Microbiological Monitoring of Bivalve Mollusc Harvesting Areas. Issue 4, August 2010, updated June 2014 (Issue 5) and January 2017 (Issue 6). Accessed online at https://www.cefas.co.uk/media/jyzhl1si/ good-practice-guide-issue-6.pdf. 4. Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 repeals Regulations (EC) No 854/2004 and (EC) No 882/2004. Accessed online at https://eurlex.europa.eu/legal-content/EN/TXT/ PDF/?uri=CELEX:32017R0625&from=EN. 5. Commission Implementing Regulation (EU) 2019/627 of 15 March 2019, lays down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls. Accessed online at https://eurlex.europa.eu/legal-content/EN/TXT/ PDF/?uri=CELEX:32019R0627&from=EN. 6. National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish. Food and Drug Administration and Interstate Shellfish Sanitation Conference. 2007 through 2017 revisions (web page last updated October 2018). See Section II, Chapter 1 @.02, page 13 and Section IV, Chapter III, .03, page 363. Accessed online at https:// www.fda.gov/food/guidanceregulation/ PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 60175 federalstatefoodprograms/ ucm2006754.htm. 7. Meeting Summary and Attachment from the U.S.-EU Bivalve Molluscan Shellfish Equivalence Project. November 19 to 20, 2015. FDA Hillandale Building, Silver Spring, MD. 8. Agreement between the United States of America and the European Community on Sanitary Measures to Protect Public and Animal Health in Trade in Live Animals and Animal Products dated July 20, 1999. 9. Administrative Arrangement between the United States Food and Drug Administration and the DirectorateGeneral for Health and Food Safety of the European Commission Regarding Trade in Bivalve Molluscan Shellfish. Dated: September 16, 2020. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2020–20755 Filed 9–23–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [CMS–3378–N] Secretarial Review and Publication of the 2019 Annual Report to Congress and the Secretary Submitted by the Consensus-Based Entity Regarding Performance Measurement Office of the Secretary of 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 2019 Annual Activities Report to Congress and the Secretary submitted by the consensus-based entity under a contract with the Secretary as mandated by the Social Security Act (the Act). The Secretary has reviewed 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 the Act. This notice fulfills the statutory requirements. FOR FURTHER INFORMATION CONTACT: Michelle Geppi, (410) 786–4844. SUPPLEMENTARY INFORMATION: SUMMARY: 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 E:\FR\FM\24SEN1.SGM 24SEN1 60176 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices (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. 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, 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. Additionally, 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, 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. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 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 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 (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 Congress to include the following: (1) An itemization of financial information for the previous fiscal year ending September 30, 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 Congress and the Secretary of HHS 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 receipt. 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 2019 activities to Congress and the Secretary on March 2, 2020. The Secretary’s Comments on this report are presented in section II. of this notice, and the National Quality Forum 2019 Activities Report to Congress and the Secretary of the Department of Health and Human Services is provided, E:\FR\FM\24SEN1.SGM 24SEN1 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices as submitted to HHS, in the addendum to this Federal Register notice in section III. II. Secretarial Comments on the National Quality Forum 2019 Activities: Report to Congress and the Secretary of the Department of Health and Human Services Once again, we thank the National Quality Forum (NQF) and the many stakeholders who participate in NQF projects for helping to advance the science and utility of health care quality measurement. As part of its annual recurring work to maintain a strong portfolio of endorsed measures for use across varied providers, settings of care, and health conditions, NQF reports that in 2019, it updated its measure portfolio by reviewing and endorsing or reendorsing 110 measures and removing 41 measures.1 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 endorsing measures and maintenance of endorsed measures, NQF also worked to remove measures from the portfolio of endorsed measures for their 14 projects related to the topics discussed in the previous paragraph for a variety of reasons, such as: Measures no longer meeting endorsement criteria; 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.2 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 HHS initiatives, such as the Meaningful Measures Initiative at the Centers for 1 National Quality Forum (NQF) (February 28, 2020) NQF 2019 Activities: Report to Congress and the Secretary of the Department of Health and Human Services. Final Report, p. 15 (https:// www.qualityforum.org/Publications/2020/02/2019_ Annual_Report_to_Congress-2147382169.aspx, accessed 3/20/2020). 2 NQF, February 28, 2020, op. cit. p. 8. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 Medicare & Medicaid Services (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. NQF uses its unique role as the CBE to undertake a partnership with CMS to support the Core Quality Measures Collaborative (CQMC). Convened by America’s Health Insurance Plans (AHIP), the CQMC is a public-private coalition, with representation by medical associations, specialty societies, public and private payers, patient and consumer groups, purchasers, and quality collaboratives. The CQMC aims to identify high-value, high-impact quality measures that promote better outcomes. The CQMC supports nationwide quality measure alignment between Medicare and private payers and in turn, advances the ongoing work to establish a health quality roadmap to improve reporting across programs and health systems, as referenced in the recent Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First.3 To date, CQMC has convened workgroups and developed eight (8) core measure sets to be used in high impact areas, including those for the topics of primary care/accountable care organizations/person-centered medical homes, cardiology, gastroenterology, HIV/Hepatitis C, medical oncology, obstetrics/gynecology, orthopedics, and pediatrics. Recognizing the importance of publicprivate collaboration, the CQMC’s work enhances measure alignment and reduces provider burden. CMS awarded NQF a 3-year contract in September 2018 to support the CQMC’s work to update and expand the core sets. In 2019, NQF convened all of the eight CQMC workgroups to update the core sets and discuss maintenance of the core sets. In addition, NQF updated and finalized the principles for selecting measures for existing and new core sets, based on the input of the workgroups. During the same period, NQF also developed the approaches for prioritizing the topics or areas for 3 The White House Executive Order, June 24, 2019: https://www.whitehouse.gov/presidentialactions/executive-order-improving-price-qualitytransparency-american-healthcare-put-patientsfirst/. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 60177 potential new core sets. Through its partnership with NQF, CMS has contributed to the CQMC by making sure that the core sets drive innovation, reflect evidence-based care, and are meaningful to all stakeholders. The work of the CQMC to develop core measure sets addresses widely recognized and long-standing challenges of quality measure reporting and helps to align quality measurement across all payers, reducing burden, simplifying reporting, and resulting in a consistent measurement process. This in turn can result in reporting on a broader number of patients, higher reliability of the measures, and improved and more accurate public reporting. Facilitating measure alignment across payers and reducing provider burden 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 appreciate the 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.). IV. Addendum In this Addendum, we are setting forth ‘‘The 2019 Annual Report to Congress and the Secretary: NQF Report on 2019 Activities to Congress and the Secretary of the Department of Health and Human Services.’’ Dated: September 18, 2020. Alex M. Azar II, Secretary, Department of Health and Human Services. BILLING CODE 4120–01–P E:\FR\FM\24SEN1.SGM 24SEN1 60178 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices NATIONAL QUALITY FORUM Driving l"l'leasWab~ l'!~altli improveme.ntstogether: NQF .2019 Activities: Report to Congress. and the Secretary of the D.epattment of Health and Hurnan Services Final Report• Febtuary:ZIJ,.2020 This reportwasfund~.bv the u.s. ~partrnent of Health and Humari Ser:vices tindifr cohtra<:t number: HHSM-S00-2017-00060! Task Order HHSM•SOO-TO<XI2; VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.009</GPH> 1 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60179 Contents r. Executive Summary ........... ,.....................,..................,................................................................... 4 II. NQF Funding and Operations......................................................................................................... 6 Ill. Recommendations on the National Quality Strategy and Priorities ................................................ 6 Priority Initiative: Align Private. and Public Quality Measurement ................................................. ,. 7 Priority Initiative: Opioid and Opioid Use Disorder....................................................................,....,. 9 IV. Quality and Efficiency Measurement lhitiatiVes.(Performance Measurenieht) ............................. 10 Cross-Cutting Projects to Improve the Measurement Process ...................................................... 11 Current State of the NQF Measure Portfolio ................................................................................ 14 Measure Endorsement and Maintenance .Accomplishments .......................................................... 15 V. Stakeholder Recommendations on Quality and Efficiency Measures and Nationa I Priorities ........ 21 Measure Applications Partnership ............................................................................................... 21 MAP.2019 Pre-Rulemaking Recommendations ......... ,; .................. ,.............................................. 22 MAP Cllnldan Workgroup ..... ,............ !•··• .. ·• ................................., ..•.•. ,......... ,.••• ,., ......,. ......... ,..... , 23 MAP· Hospital Workgroup, ..................... ,...............,.,. ...................................... ,............................ 24 MAP PAC/LTC Workgroup. ................ ,................... ,,. ................................... ,, .. ,.• ,............................ 25 2019.M!!asurement Guidance for Medicaid Scorecard ..........................,....................................... 27 VI.. Gaps ln Endorsed Qi.i,ality and Efficiency Measures ....................................................................... 28 Gaps Identified in 2019 Completed Projects ....................................................................,, ..... ,..... ·29 Measure Applications Partnership: Identifying and Filling Measure Gaps ....................... ,............. 29 VII, Gaps in Evidehce and Targeted Research Ne,eds ...... ,.. .................................................................. 29 Populatioil•Based Trauma Outcomes........................................................................................... 29 Healthcare Systems Readiness .......................................................................~ ..............................·30 ChiefComplaint•Based Quality for Emergency Care ........... ,,. ........................................................ 32 Common Formats for Patient Safety ............................ ,,....................................................... ,............ 33 Person-Centered ·Planning and Practice .............................. ,,...................... ~ ................................... 34 Measure· Feedback·Loop ..............,................................................................................................ 35 Electronic Health Record. Dati:i Quality .................................... ,,......,...... , ....................................... 37 Reducing Diagnostic Error............... ,........................ ,............................ ,................... ,................... 38 Maternal Morbidity and Mortalfty ..................................................,......... ,...................................... 39 VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.010</GPH> 2 60180 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Appendix A: 2019 Activities Performed Under Contract with HHS .......................................................... 47 Appendix B: Multistakeholder Group Rosters: Committee, Workgroups, Task Forces, and Advisory Panels ................................................................................................................................................... 51 Appendix C: Scientific Methods Panel Roster ......................................................................................... 57 Appendix D: MAP Measure Selection Criteria,. ........................,.. .................................. ,.. ...................... 58 Appendix E: MAP Structure, Members, Criteria for Service, and Rosters ................................................ 61 Appendix F: Federal Quality Reporting and Performance-Based Payment Programs Considered by MAP ........................................................................................................,............................................. 63 Appendix G: Identified Gaps by NQF Measure Portfolio ......................................................................... 64 Appendix H: Medicare Measure Gaps Identified by NQF's Measure Applications Partnership ................ 66 Appendix I: Statutory Requirement of Annual ReportComponents ........................................................ 68 VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.011</GPH> 3 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60181 I. Executiva:Summary The Niitlorilil Quality forum (NQF)wor:ks with members ofthe healthcare.c:ommunityto drive measurableheah:h improvements together. N<lf isa•not-for-profit; membel"$hlp-based organization that giVes all hea!thearesta~el'toli:(ero vpice in advancing quality rne.asuresa_nd lmprovementstl'll:t',egit!sttlat leacUo•better·oub:Qmes..snd greater.value. ·0r1venby science, c:olla'boration1 and proven.outcomes,:NQ.F ~psmoye l'l'luliiplepe~es in.to ~11; Balancing different groups' perspectives in an open and honest dialogue is coreto itswoi'k, NQf brings ~ther dc>ttol:S, healtlt~n!i, hosptt:als•and·Pil~ntsandcar~ers~:unitediv.sestakehQidm ori important Issues of oommon need, NQF uniquely a:ndpul'pmef:till:V Integrates patients ant.tc::areghiets to offera ~I playii,gfield fonll stcilke~c>lder$ tpJiave avoial Iii ~fining and irnpt"OVlng health ~are quaijty. QlltlRfy~~nce. •u,,e,s-onct'IA«#11l'fl.£ndorse,mttit j'jQF~s reaM11mended'.ttte: 1:iest~!l'l"C:la:ss·q1.U1lity meas\il'es fe1n,i5e:in.fedetal and prwa~Improverne11t programsftirtWodecade$,}lighiyvetted and trusted NQFend<mied measures QJ>erate Iii key; ~tutoiily mandated Medicare programs such asthe Q,.iality Payment Program; Hospital Value-Based Purchasing Prt!gr..amlln~ o~r reporting imt1ativesln,;.,a(iouSctail! setti11:gs, Fedttralirnprovementprograms~t~ NUF-endii"$ed:quality m~stires h~ tatuced patient fiarm iriho$pifals.~y 21 percerit saving 12•s,ooo lives and $28 blllion.tncosts. Jhe:3;1 mUllon fewer-.harms:to·patients achieved from 2010-2015· im:ludn 91. per~t~-aseinJ:entral n~·infettiClns:and a 16,,ertentdecreasein surgicalsite:infettionsi. Hospital reitdmis!iionrates for Matic:ere patients have dea:easet.1by s pettient s1nce2012; Aligni~thiitpii<>titi:zatioii ofsuch wort with thE!Ceti_terdor Medidire•.& Metliaid Ser\i_ices> (CMS) .. ;Meanlflgful Menu~ iS eri&al to,the ovetall:goalsofredudiig heaithcarecosts:and imf>i'.OVingquality :--::=====s-==~T ·eni:f~~t·of_~·b.-sed,. prC)Yetl.,mt1:•effec~·me•~es all'oWsfcit1»11tinued re-<k!ctli>ri•l~• heattticare:~•and 1mp~emenlQfquillity;ei'isuresthatAm_erlans have safe,:~iwand Mg& valueh91thciire~amffillsimporl:iintgaps·inmeasurenieni Burdenlledudion otld~Allgnment Measure··aligtimerihicrO!i$the:·publicartt1t,nvate~tortatuees:burderiforpi'Q\iiderdnddlrifoiansan.d allov.isforqualltytompitrisons•across provlder$·and'programs.:through·•the.Measure-AppllcatiC>ri$: ·pa~ip (MAPlan((·•the:Core:Qoa~ty:~iilJi:'l!S·@l~bc>rative; t-lQF~~ p@ilte'.iitid]:llli>Jk·f)aymel'lt programs focus on those measuresthatw!Uhiivethe mostfriiJ>iict •· !:n!::~ve:!::~::z::n=~~;:::=~i::=:t~::::~rams. R rE1Ct!ffl'11e 11dsmeasuresthatempo\¥er·patienb;~ ~•actbteheatthcareconsuntet$.alld•support•theit. dficlsion:miiklng; are not qverlybordenso~ on jttoiii~~am:lcan supportthe•&ari$ition to;a SV$tein ·ihatpays basecfoii value ofcare. lmportaritli(i it provides a coordinated look'a-cross fec:h!ral programs to ·~~tiff perfur'11a11cemea.s.uresb¢1r1g~iijete<J, asa- way·~ impri:we ali&n!'fte11ta.tr0$$the.heaith:eate system. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.012</GPH> 4 60182 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices NQF has used its unique convening power to bring together the Core Quality Measures Collaborative (CQMC), a broad-based coalition of health care leaders induding CMS, health insurance providers, medical associations, consumer groups, purchasers, and other quality collaboratives, The CQMC is committed to promoting quality measure alignment across the public and private healthcare sectors and has developed several core measure sets for use in multiple clinical areas. The next phase of this project will focus on strategies to increase core set adoption across public and private payers to better promote alignment. Value Based Care NQF actively works with CMS to advance the transition to value, ensure that the right quality measures are leveraged to promote high quality care and outcomes through value-based care arrangements while simultaneously looking for ways to streamline measures to reduce quality reporting burden. One of those key areas is rural health, Low case-volume of patients is often at the root of quality measurement challenges for rural health providers and it presents a significant problem for many rural providers, particularly when they want to compare their performance to that of other providers or assess change in quality over time. NQF convened a multi-stakeholder rural health care committee on promising statistical methods that could address the low case-volume challenge. The report offers key recommendations that public and private stakeholders can act on to promote use of reliable, valid, and relevant measures in rural areas. NQF has also embarked on a new multi-year project that will identify high-priority measures that are important and relevant to rural providers for quality improvement efforts for future testing of the approaches recommended by the multistakeholder committee. Addressing National Health Priorities NQF is committed to addressing national health priorities and collaborating with important stakeholders to drive better outcomes. Critical health priorities are often areas where significant gaps in quality measurement exist NQF provides specific actionable approaches to improve the current state of measurement and health outcomes in high priority areas such as opioid use and maternal mortality, The U,S. is the only industrialized nation with rising maternal mortality rates and significant racial disparities in pregnancy-related deaths persist, creating an urgency for public health and healthcare delivery systems. Through a multi-year project, NQF is beginning to address morbidity and mortality through the development of actionable approaches that would improve maternal health outcomes, This includes an environmental scan to assess the current state of maternal morbidity and mortality measurement, developing frameworks and the including identification of measurement gaps and innovative quality measurement strategies to enhance care. Despite a national crisis, only 8 opioid measures have been endorsed by NQF. There are currently several more measures under consideration or under comment however there is much more work to be done in this area. NQF recently released a report with recommendations on the priority measurement gaps that need to be filled in order to reduce opioid use disorders (OUD} and existing and conceptual measures that should be deployed in federal reporting programs, Taken together, NQF's quality work continues to be foundational to efforts to achieve a cost-efficient, high-quality, value-based healthcare system that ensures the best care for Americans and the best use VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.013</GPH> 5 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60183 ofttie !'lllfio1ts,.~lthCJretloll!ilrs;The~l~~bles:fi.lC:l.l' prc:,tl~ uQ<lerCQr!~!il~INlth tlt!S 1,r2Q]$ ,1~ t~e~ throughouUhis~:andafull IistisincludediitAppefidix A. - R:ir rit(Ste infomtffi9rion)hl! wntentsofthis ~rtas required mstatutory language; please ;eferen~ t,ppel'ldlgJ. - ~;:-=-~J:r-=::n::J;!':J..~ ~?~===~=~~= ::::=:::i:=:=~;1!9:'f::;tt::::~:~~ctof yeat;induding: . . Q o ,Annual eJqHUl$esoJtheentity,(indudinggrantspaid, benefit.spa/ii; sdlanes.andoiti~e,,;mpe_h$atl<>ri;fe11dtJ1isiiJg~rfSIS; Wit/~v:etfie9d cost$_};-®d · · __ o "11• lmiokl/twt,rroJthefllfl011nt01NtJn/ed,petcontra,cteeftaik~tcwdiihe•s~(iio}ef;ts funded in each toskiifderi:mlgi'ied to: the entity · · · •w::re;::::r::::::,:=::::t:::t::::zr:r:::~=~ ==e:~=~~ ..r:::::/:isr:i=::::::r:::'°":~cttorb/"(Jllef!~ - -groups; taskforces;•andadvisorypc1nel$funded.-thraughgovemmentcontra.cts; ·desr:liptions•o/ .relew;tit11.1tere$:ttt"1•linY~~JjJintet~.for~rs-0Jd,ttQmtni~-·Wt>ffeg@11AAtt1sk As part olSettion,50200 of the: Bipartisan BudgetAd ol2018, Congress reauthorized funds foraCBE: through'fiscalyear{FV):2019. To thatend~ HHS awai'dedat<intraa to,NOF to serveasthe•CBE under this Al:t ~F•cc,nt,1fiue$~•l,eanfo~11\ npt~fur-profit;: rneri1bershlfbli~:~11rilzatiot!that·brti\p vanedhe.iltbcare•stikeholde1S:together:to_ptit.lorth quality•me:asuremenland impn,vemeritstrategies thatretl~~ts~dhelp·pat1~~•r~lve.l>e~Qre, ~~~v!!~:==:·::~::~~~:!:::~~~u::~ fur-·f¥20l:9. were$19,59~i612,Theseexpenses:includegrantsand·benefiupaid,salarie:Sandother con1Pf!!1saf,l~.~~lng~~l'.lses,aQ<love,:heacJ:~, Awmpietebreakd01Nnoftheamount:awardecl•per-·conttactisavallilble·ln·,!)'ppendl!A• NQ,Fhasmade. -~ upj:Jatest!rmod~i:ii'I$ to:d~te i:if ir1terestarid C®flictofintet;estpplide$; Rosters of eomm11:teesandwdtkgrotip$•tumtecl•uri<lerthecC:BE'contrac:ta~ •vailabte.mAAPemliXI_ ~on==:=::-:ty~:r::~:==~=~ns~w'tsec1,ntity(~ty} sh.l!/l"sfn.t!t~'te.ev~ ai14~ k~1tstt:i~ho!~ to fl'!'1ke•~i1!1qt/Oi)Sc, , • (111 !1hfh~r,l:rttet$ iiatiomilsuategyaridpiiorifiesforheafthcatefJeiformancemeas,1remeiitin.a11ar,p1iaiblesettings,·•1n· m1il<ingsw:;h_~mend¢.tiQ11S;-fhe-entJtyshiill.ens11~thatprlorig,lsgillen-tt:JmetJ$!/.re$;(i}thcttadiJ~ tii~h.~C(J(tip,rjffiikiftt;.~tswitti p~e,tt;.Ji~f#i~ic.4ise(!sei;·(fl)wi.tfi"t:lli!~t¢$t'. potentkdfor·lmj,roving•theqiiality/e/Pden<:y,•·atidpatknt-ctmteredhessofhealthtitre;i:Jnd(iil)thritti?Qy VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.014</GPH> 6 60184 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices be implemented rapidly due to existing evidence, standards of core, or other reasons." In addition, the entity 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 (ii,] address the continuum of care a patient receives, induding services furnished by multiple health care providers or practitioners and across multiple settings. "2 At the request of HHS, the NQF-convened National Priorities Partnership (NPP) provided input that helped shape the initial version of the NQS, released by HHS in 2011. The NQS set out a comprehensive roadmap for the country that focuses on achieving better, more affordable care. It also emphasized the need for healthcare stakeholders across the country, both public and private, to play a role in making the initiative a success. Annually, NQF continues to endorse measures through our core endorsement process that link to these priorities by convening diverse stakeholder groups to reach consensus on key strategies for performance measurement and quality improvement. further, NQF began work focused on key issues that address the changing measurement landscape, including, but not limited to, changes in clinical practice guidelines, data sources, or risk adjustment across both the public and private sectors. In late 2018, NQF convened the Core Quality Measures Collaborative (CQMC}, a multistakeholder collaborative to ensure that the right quality measures are being used across payers, aligning with the NQS' emphasis on publicprivate collaboration. In addition, NQF began work in 2019 on an urgent national priority area-to address challenges in opioid and OUD quality measurement More details about NQF's endorsement work is in Section IV. Quality and Efficiency Measurement Initiatives (Performance Measurement). More information about NQF's priority initiatives on public-private payer alignment and OUDs follows below. Priority Initiative: Align Private and Public Quality Measurement A majority of Americans receive care through a value-based care arrangement, one that ties payment to the quality of care, Both public- and private-sector payers use VBP to ensure care is high quality and cost efficient. Ensuring the right quality measures are used across payers is essential to delivering results that will lead to a better healthcare system and reduce clinician burden. One response was America's Health Insurance Plans (AHIP) convening a collaborative including CMS, NQF, health plans, physician specialty societies, employers, and consumers. The voluntary collaborative sought to add focus to quality improvement efforts; reduce the reporting burden for providers; and offer consumers actionable information to help them make decisions about where to receive their care. More specifically, the collaborative has three main aims: 1, Identify high value, high-impact, evidence-based measures that promote better patient outcomes, and provide useful information for improvement, decision making, and outcomesbased payment. 2. Align measures across public and private health insurance providers to achieve congruence in the measures being used for quality improvement, transparency, and payment purposes. 3. Reduce the burden of measurement by eliminating low-value metrics, redundancies, and inconsistencies in measure specifications and reporting requirements across public and private health insurance providers. The collaborative developed and released eight core sets of quality measures in 2016 on key areas including: VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.015</GPH> 7 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices • • • • • • • • 60185 Accountable Care Organizations (ACOs}, Patient-Centered Medical Homes (PCMH}, and Primary Care Cardiology GastroenterQlogy fllV and Hepatitis C Medtcal Oncology Obstetrics and Gynecology Orthopedics Pediatrics ln 2018, CMS and AHIP~ partnership With HOF-reconvened and formalized the CQMC to continue its alignment efforts and improve healthcare quality for every American. First, the CQMc established a structure for creating, maintaining, and finalizing a>re measure se~ This process included refining the principles for core set measure selection and developing approaches to future core set prioritization, Next, NQF convened the CQMC to update the existing eight core sets. CQMCworkgroups, made up of subsets of CQMC members with expertise in the respective topic• areas, reviewed new measures that could be added to the ror~ sets to address high0 priority areas. The workgroups alsp removed measures that no longer showed an opportunity for improvement, did not align with clinical guidelines, or have implementation chaHenges. The workgroups also atSCUSSed measurement gaps and adoption successes and challenges. In 2019~ NQF convened all CQMC workgroups to discuss the maintenance ofthe·core sets. The HIV/Hepatitis C and Gastroenterology workgroops finalized their maintenance discussion arid voted on measures to be added or removed from their respective existing core sets. Voting results for the two workgroups were presented to the Steering Committee and are waiting to be presented to the full collaborative for final approval in early 2020. Voting results for the Cardiology, Orthopedics, arid Pediatrics core sets were finalized and await presentation to the Steering Committee by early 2020. The Medical Oncology, ACO, arid Obstetrics and Gynecology workgroups are yet to finalize their maintenance discussion. The remaining three workgroups will finalize their maintenance discussions in early 2020 arid will complete voting by spring 2020. in the coming year, NQF Will continue to provide guidance and technical support to the CQMt on updating core measure sets, expanding into new clinical areas and ps:oviding guidance to stakeholders seeking to use the core set measures. Planned work includes finalizing the eight updated core sets arid creating new core sets for behavioral health arid neurology. NQF wi11 also work collaboratively with CQMC members to develop strategies for facilitating implementation across care settings arid promoting measure alignment. Moving forward, NQF will also convene aworkgroup to create an implementation guide. This resource will provide guidance on resolving technical issues related to adoption arid increasing stakeholder knowledge of the core sets. The CQMC will also use the updated prioritization criteria.to consider additional areas of work. NQf will conduct an analysis of gaps and measure specification variation in the core measure sets. These activities Will increase use arid widen the adoption of the core sets, thereby reducing the burden of measurement for payeB and clinicians. See the collaboratlve's website fur mote information at http:1/www,qualityforum.org/cgmc/. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.016</GPH> 8 60186 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Priority Initiative: Opioid and Opioid Use Disorder Opioid-related overdose deaths and morbidity have increased in epidemic proportions over the last 10 years. In 2019, the Morbidity and Mortality Weekly Report confirmed that in 2017 there were over 47,000 U.S. deaths attributable to opioid use, both prescription and illicit.' These numbers eclipse the total mortality related to other crises including peak automobile accidents, the Vietnam war, HIV/AIDS, and gun violence in this country. 4 Moreover, a large proportion of those deaths are tied to heroin that is laced with illegally manufactured fentanyl, s-7 a substance available in patch form to treat chronic pain. This salient trend demonstrates an epidemic that is partly tied to unintended effects of regular medical care. More specifically, it has been well-documented that the recent rise in opioid use and dependence largely relates to trends over the past 20 years to expand the therapeutic use of opioids like Oxycontin to treat acute and chronic pain. a-io In fact, opioid prescriptions have become so prevalent that currently the U.S. legally distributes more opioids per capita than any other nation, many times over. 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. 11 The response to the opioid overdose epidemic included congressional action in the form of legislation to permit federal agencies to enhance their efforts to address pain management and OUDs-the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act Section 6093, signed by President Trump in October 2018. That law expanded funding mechanisms for substance use disorder (SUD), and further required examination of the coverage, payment, and treatment issues in Medicare and Medicaid regarding OUDs and pain management The SUPPORT Act also called for the establishment of a "technical expert panel for the purpose of reviewing quality measures relating to opioids and opioid use disorders including care, prevention, diagnosis, health outcomes and treatment furnished to individuals with opioid use disorders." Under the authority of this law, HHS contracted with NQF to establish a multistakeholder technical expert panel (TEP) to consider QUO.related quality measures within an environmental scan. This included an inventory of existing measures, measure concepts (i.e., measures that have not been fully specified and tested), and apparent gaps. In 2019, NQF convened a 28-member TEP and began a multiphased approach to address prominent challenges regarding quality measurement science as it relates to OUDs. As called for in the SUPPORT Act, the TEP was directed to do the following: 1. Review quality measures that relate to OUDs, induding those that are fully developed or are 2. Identify gaps in areas that relate to OUDs, and identify measure development priorities for such under development; measure gaps; and 3. Make recommendations to HHS on quality measures with respect to OUDs for purposes of improving care, prevention, diagnosis, health outcomes, and treatment, including recommendations for revisions of such measures, need for development of new measures, and recommendations for including such measures in the Merit-Based Incentive Payment System (MIPS), APMs, the Shared Savings Program (SSP), the Hospital Inpatient Quality Reporting (IQR) program and the Hospital VBP program. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.017</GPH> 9 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60187 To inform the TEP's work, NQF first conducted an environmental scan of the current landscape of quality and performance measures and measure concepts that could be used to assess opioid use, OUD, and overdose. The environmental scan resulted in identification of a total of 207 measures and 71 measure concepts categorized into four domains-Pain Management, Treatment of OUD, Harm Reduction, and Social Issues. Measures and measure concepts were then further divided into smaller groupings within each domain to organize the measures and facilitate the identification of measure gaps. The next phase of this project included developing recommendations that specifically identified the prioritized gaps in measure concepts for OUDs. It also provided guidance on OUD measurement for federal programs. The TEP identified five priority gaps/concepts that have multiple dimensions and multiple level-of-analysis targets, which are summarized here: • Measures of opioid tapering, and more general measures related to the treatment of acute and chronic pain, are essential to addressing the opioid crisis. • The inclusion of some measures for special populations such as pregnant women, newborns, racial subgroups, and detained persons is important. • Long-term follow-up of clients being treated for OUD across time and providers is important to assess even though there are data challenges. • Pain management, OUD treatment, SUD treatment, and treatment of physical and mental health comorbidities are all important. The guidance on opioid and OUD measurement for federal programs included recommendations on the measures that should be included in these programs, whether revisions of measures should be considered or if there is a need for development of new measures. The applicable federal programs and payment models for these recommendations are MIPS; APMs; SSP; !QR; and the hospital VBP program. In consideration of each program, the TEP reviewed the measures and measure concepts applying them to each of the five federal programs. A ~ of the review process, TEP discussion, and recommendations is available to the public for comment and was finalized in February 2020. IV. Quality and Efficiency Measurement Initiatives (Performance Measurement) Section l890{b)(2) and (3) of the Socio/ Security Act requires the consensus-based entity (CB£) 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 in patient characteristics, and consistent across types of healthcare providers. In addition, the CB£ must establish and implement a process to ensure that measures endorsed are updated (or retired if obsolete) as new evidence is developed. NQF works closely with many different stakeholders across the healthcare spectrum, including providers, patients, healthcare systems, hospitals, insurers, employers, and many more. Diverse stakeholder involvement and perspectives facilitate an equitable review and endorsement of healthcare performance measures. NQF-endorsed measures are used in a variety of ways. Providers use them to help understand whether the care they provide to their patients is optimal and appropriate. Federal and state governments use performance measures to identify where to focus quality improvement efforts and evaluate performance. Healthcare performance measures further enhance healthcare value by VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.018</GPH> 10 60188 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices ensuring consistent, high quality data are available, which ultimately allows for comparisons across providers, programs, and states. Currently, NQF has a portfolio of 520 endorsed measures used across the healthcare system, Subsets of this portfolio apply to particular settings and levels of analysis. Cross-Cutting Projects to Improve the Measurement Process ln 2019, NQF undertook two projects to expand the science Of performance measurement the Social Risk Trial and the Rural Health Technical Expert Panel. These projects aimed to.provide greater insights into measure methodology and future guidance for NQF's work to endocse performance measures. NQF explored ways to address attribution models; that is, the methodology through which a patient and their healthcare outcomes are assigned to a provider. NQF also examined the ongoing issue of how to account for the influence that a person's socioeconomic status or other social risk factors can have On their healthcare outcomes-and the challenges faced by rural providers to meet the reporting requirements in various CMS quality programs. SodallliskTrlal Outcome measures-like those related to mortality, readmissions, or complications-have been playing an increasingly importantmie in VBP programs for public and private payers. More often than not, healthcare outcomes are not solely the results of the quality of care received but can be influenced by factors outside a provider's .control, such as a patient's age, gender, comorbid conditions, severity of ilfness, or socioeconomic factors. Based on the input of a TEP, NQF published a report in 2014 recommending that performance measures.should account for these underlying differences lrt patients' health risk~ clinical or socioeconomk:, if there is a conceptual basis fur doing so to ensure measures make fafr condusions about provider quality. Risk-adjusting outcome measures to account fur differences iii patient health status and clinical factors (e.g., comorbidities, severity of illness) thatare present at the start of care is widely accepted. However, it is also well-documented that a person's social rlsk factors (i.e., sodoeconomicand demographic factors) can also affect health outcomes. In the past, NQF's policy forbid risk adjustment for social dsk factors, due to concern aboutthe possibility of masking disparities or creating lower standards of care for people with social risk factors. Based on the 2014 report mentioned earlier, 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 re-endorsement. Soon after the trial, NQF released a final report in August 2017, reaffirming the recommendation in its 2014 report that perfurmanee measures should be risk adjusted for social risk factors if there is a conceptual basis for doing so. Also, stakehoiders called fur continuous. efforts to examine some of the technical issues that remained incondusive at the end of the firsftrial. In response to stakeholders' concerns, HHS has funded NQF to implement a second Social Risk Trial,a three-year effort that began in May 2018 and will be completed by May 2021. As part of this worl<, NQFhas continued working with the Disparities Standing Committee and builds on the lessons of the initial NQHunded Social Risk Trial initiative. In 2019, the Disparities Committee met to review the risk-adjusted measures for the spring and fall 2019 cycle submissions, review the risk models in use, and interpret results. The table below provides an overview of the measures submitted and initial analysis. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.019</GPH> 11 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices TotalNumbclrof Measures Reviewed N!lmberofoutcomerneasures (lncl1.1dfng lntermediateoutt0me ..ilid patiJel'lt~"'ported o\rtcome-based performance measures (PRO~PM)} Number of measures tl:latused some of'rlsk adjustment 3Sof127 Number of measures that provided a conceptual rationale for potentiafimpact ofsocial 32 of 127 form 60189 127 risk factors The measure devalopers established the corii:eptualtafionale tosupPorfthe potentialimpactofsocial risk factors through literature reviews, Internal da.ta analysis; or expert group consensus. Some of the social risk factcirs:consid:erecilndude race/ethnicity, p.iyer, Agency for Healthcare Resel'lrch an<!. QuaUty (AHRQ) soooeconomieStatus (SES) Index, education, employrnentstatus, ZIP code, rural/urban, relationship status, income, and language. Reasons cited for not adjusting induded negligible impattof SES adjqstment, potential to mask poor performance .ind disp.inties in care, and relati~ly constant distribution ofpatients with risk factors. Slhce 2017, .there have been 276 measures submltted; 108 of those used some form <>frisk adJu~ment, and 100 measures had a com:eptual modefoutlining the impact ohocial risk;. Many ofthe measures submltted were process measures (44 percent), but the overall portfolio of measures included other measure types such as c:omposite,.efficiency, intermediate outcome, outoome, PRO-PM, resource use, and structural measures. In 2020, NQf wlll continue to explore the impact of social risk .factors on the results of measures and the appropriateness of lncluding soclal risk. factCll's in the.risk-adjustment m.odels of measures submitted for end()fsement review (if there is a tonceptual basis and empirical evidence to support dt>ing so}. The ongoing work.of the Social Risk Trial. period wlll advance the sdence of r.isk.adjustment and provide. expert suld,nte to address the chaltengesand opportunities related to including social risk fai:torsln risk7adjustment models: The final reportfot this projectwill be completed in May 2021. Rutol Heotth T~tmlo:1/EJqwt. Panel Compared to the urban and suburban regions in the U.S., rural communities have higher proportions of elderly residents, higher rates of poverty, greaterb1.1rden. ofchronic.diseases (e,g,, diabetes, hypertension,. and chronic obstructive pulmonary disease), and limited actess to the healthcare delivery system. While 60 percent ofall trauma deaths:ln the U.S. occur in rural areas, only 24 percent of rural residents have access.to a trauma center, compared tt> 85 percent for.all U.S. urban and suburban residents, underscoring the severity of insufficient a<;eeSS'.tocare. Rural healthcare pr®l~rs face many challengE!s in reporting quality measurementdata and implementing care irnprovementefforts to address the needs of their populations. Low case-volume presents a slgnific;11'.1t me~urement challenge for many rural pr~!ders to.reportmeasures; maldnglt diffltultfor them to tom pate the.Ir performance tQ that ofQther pr®iders (both rural and Mn-turaQ:, identify topics for lmpro:vement,or assess change in qualify over time. Rural areas are, by definition;. sp.irsely popUlated, and this can affect the n1.1mberof patients !:)ligible fufinclqs1on in healthcare performance measures, particularly cotidifioo• or ptOcedure-specific measures. The low ~volume challenge for rural providers is further aggravated by geographical remoteness and lack of transportation.options for rural residen~ VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.020</GPH> 12 60190 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices ln 2018, as an extension of NQF's work in convening the MAP Rural Health Workgroup, CMS tasked NQF with eliciting expert input on promising statistical approaches that could address the low case-volumii! challenge as it pertains to healthcare perfurmance measurement of rural providers. I\IQF began this new work by converung a five-member TEP. As part of the effurt, the TEP reviewed previously identified approaches to the low case-volume challenge and offered new recommendations as appropriate. In fulfilling its charge, the TEP considered exemptions for reporting requirements for rural providers in various CMS quality programs, as well as the heterogeneity of the residents and healthcare providers 111 rural areas. As part of their work, TEP members considered the following ways of defining low case-volume for the purposes of the report and its recommendations: • • • Too few individuals meet the measure denominator Too few individuals meet the measure numerator As defined by specific program reporting requirements (i.e., reporting thresholds) The TEP ultimately agreed to consider low-case volume primarily as having too few individuals that meet the measure denominator criteria. Members noted that some measures, by design, will have very low numerator counts (e.g., measures of patient safety "never events"}, and that consideration ofthe magnitude of the numerator, relative to that of the denominator, may be of more interestthan focusing on the numerator. Regarding use ofspeclfic program reporting requirements to define low case-volume, TEP members noted that thresholds fut reporting often are implemented due to concerns about privacy, which are different from concerns regarding low case-volume and its resulting effects on score-level reliability. Thus, the TEP decided to consider the various program-specific thresholds on a case-bycease basis, if necessary, rather than use. them to define low case-volume fur the report, The TEP also discussed whether to consider complete lack of service provision (e.g., a hospital does not perform deliveries) as a part of their deliberations. Members agreed that this is a missing-data problem within the context of composite measures and program design, rather than.a low-case•volume problem. Therefore, they decided that this situation was.out of scope fur the report. The TEP's four key recommendations to address the low-case-volume challenge are to: 1) "borrow strength" for low-case-volume rural providers to the extent possible. by systematically incorporating addltional data as needed {e.g., from past performance, from other providers, from other measures, etc.); 2) recognize the need for robust statistical expertise and computational power to imptement the recommended modeling approach of borrowing strength; 3} report exceedarn::e probabilities (exceedance probabilities, like confidence intervals, reflect the uncertainty of measure results); 4) and anticipate the potential for unintended consequences of measurement. TEP members also suggested several additional ideas for future work that could further address the low-case-volume challenge for rural providers, including both research and policy activities: • • Apply the recommendation of borrowing strength to the extent possible in a simulation study. Implement a "challenge grant" by providing either real or simulated data of rural providers with low case-volume-again, where the true quality of the providers is known~and ask volunteer researchers to apply various methods to address the problem. • Explore which structural characteristics might-be appropriate in defining shrinkage targets for performance measurement of rural providers. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.021</GPH> 13 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices • • Bring together experts from other disciplines (such as education}, who also must contend with the small-denominator problem, in order to share best practices for measurement and reporting. Explore nonparametric alternatives when developing measures for rural providers. • .Determine whether, and ifso, how, to ronsider the smaU-numerator problE!m, particularly from the rural perspective. The small'-Oumerator problem, whfch was considered out of scope by the Ti:P fur this project, occurs when.few individuals meet the measure numerator. • Explore the policy rationale for various approaches to measurement in rural areas,particularly considering quality improvement and access rather than competition. Explore the implications of lack of service delivery {e.g., obstetrk:al services, mental health services) in rural areas on performance measurement, particularly in the context of actual or theoretical pay-fur-performance program structures. Revisit the cOre set of rural-relevant measures idi:mtified in 2018 by the MAP Rural Health Workgtoup on an ongoing basis to ensure that rural residents and provt'ders find these measures meaningful. Continue to explore ways to ensure thatrural provt'ders can meaningfully participate in quality programs, both public and private. • • • 60191 The final report from the Rural Health Technk:al Expert Panel was published in April2019. CurrentState of the NQF Measure Portfolio In 2019, NQF's measure portfolio contained 520 measures across a variety oh:link:al and cross-cutting topic areas. Forty-five percent of the measures in NQF's portfolio are outcome measures. NQF's multlstakeholder committees-comprising stakeholders from across the healthcare landscape includiog consumers, providers, patients, payers, and other experts-review both pr.eviously endorsed and new measures submitted using NQF's rigorousmeasure evaluation criteria. All measures.submitted for NQF endorsement are evaluated against the following criteria: • lmportanc:eto Measure and Report • Reliabifity and Validity~Scientific Acceptability of Measure Properties • Feasibility • • Usability and Use Comparison to Related or Competing Measures NQF encourages measure developers to submit measures that can drive meaningful improvements in care and fill known measure gaps that align with healthcare improvement priorities. NQF brings together multistakeholdercommittees to-evaluate measures for endorsement twice a year, with submission opportunities in the spring and fall of each year. This frequent review process allows measure developers to receive a timely review oftheir measures, in addition to reducing committee downtime between review cycles.. More information is available in Measure Evaluation Criteria and Guidance for Evaluating Measures fur Endorsement NQF's portfolio of endorsed measures undergoes evaluation fur maintenance ofendorsement approximately every three years. The maintenance process ensures that NQF-endorsed measures represent current dinical evidence, continue to have a meaningful opportunity to improve, and have been implemented without negative unintended c0nsequences. In a maintenance review; NQF multistakeholder committees review previously endorsed measures to ensure that they still meet NQF VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.022</GPH> 14 60192 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices criteria for endorsement This maintenance review may result in removing endorsement for measures that no longer meet rigorous criteria, facilitating measure harmonization among competing or similar measures, or retiring measures that no longer provide significant opportunities for improvement. Measure Endorsement and Maintenance Accomplishments In 2017, NQF redesigned the endorsement process, creating an opportunity for measure developers to submit measures for endorsement consideration twice each year (spring and fall). As a result, in 2019, NQF convened 14 multistakeholder topic-specific standing committees for 28 quality measure endorsement projects {two projects per committee} to review submitted measures. This report highlights the outcomes of the three measure submission and review cycles that had activity in 2019: the completion of the review of measures submitted in the prior year (November 2018/fall 2018) and measure review cycles started in the calendar year addressed by this report (April 2019/spring 2019 and November 2019/fall 2019). Also, as a result of the 2017 redesign, NQF convened the 40-member Scientific Methods Panel (SMP) to assist with the methodological review of complex measures prior to committee review of measures. Complex measures may include outcome measures, instrument-based measures (e.g., PRO-PMs), cost/resource use measures, efficiency measures, and composite measures) across all 14 topic areas. The SM P's review focuses on the measure's Scientific Acceptability {specifically, the "must-pass" subcriteria of reliability and validity), using NQFs standard measure evaluation criteria for new and maintenance measures. The Panel's feedback is critical input for standing committee endorsement recommendations. To that end, the Panel evaluated 72 complex measures in 2019. Next, NQF's 14 multistakeholder standing committees reviewed and evaluated the measures. While some measure endorsement projects received measures for review each cycle, others did not. When standing committees did not receive measures, they instead convened to discuss overarching issues related to measurement in their topic area; these projects included Cancer and Prevention and Population Health. Through projects completed in 2019 with standing committees receiving measures, NQF endorsed 110 measures and removed 41 measures from its portfolio. ~ lists the types of measures reviewed in 2019 and the results of the review. Below are summaries of endorsement projects completed in 2019, as well as projects that began but were not completed before the end of the year. All-Cause Admissions and Readmissions A hospital readmission can be defined as patient admission to a hospital within 30 days after being discharged from an earlier hospital stay.12 Hospital admissions and readmissions rates are influenced by various factors (e.g., socioeconomic status) and often are unavoidable and necessary. 13 To drive improvement in admissions and readmissions rates, performance measures have continued to be a key element of VBP programs to incentivize collaboration in the healthcare delivery system. NQF's current portfolio includes 51 endorsed admissions and readmissions measures, including all-cause and condition-specific admissions and readmissions measures addressing numerous settings. Many of these measures are used in private and federal quality reporting and VBP programs, including CMS' Hospital Readmissions Reduction Program (HRRP) as part of ongoing efforts to reduce avoidable admissions and readmissions. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.023</GPH> 15 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60193 During thefall 2018 review cycle, the All-Cause Admissions and Readmissions Standing Committee evaluated seven measures. four were endorsed, and the remaining three were not endorsed due to concerns about the measures' validity. The fall 2018 cycle concluded in August 2019, and the nnal report was published in August 2019. Duringthe snring 2019 review cycle, nve measures were evaluated, none of which was endorsed. One new measure was withdrawn from.consideration. Another new measure was split and assessed at two levels of analysis, with one not endorsed and one deferred to .the rail 2019 review cycle, Two more measures deferred from the fall 2018 cycle were not endorsed. One measure will be reviewed during the fall 2019 cyde. Behavioral Health and Substance Use Behavioral health-including psychiatric illness (mental illness) and SUDs-45 an important construct that reflects the interwoven complexities of human behavior and its neurological underpinnings.14 As of 2018, approximately 57 million adolescent and adult Americans suffer from substantive behavioral health disorder, and the need for treatment remains very high, with only about1S. percent of.those with SUD and 43 percent for those with any Ml being able to access treatment NQF' s current portfolio includes 49 endorsed behavioral health measures pertaining to the treatment of depression, psychosis, attentional disorders, and SUDs. Ouring the fall 2018 cyde. the Behavioral Health and Substance Use Standing Committee evaluated four measures against NQF's measure evaluation criteria. Two were new measures, and two were undergoing maintenance review; Of the four, three measures were endorsed, and one measure did not pass the NQF Evidence criterion and was not recommended for endorsement due to concern about the sensitivity and specificity of both the numerator and denominator. During the spring 2019 cycle. the committee reviewed two new measures, and four measures undergoing maintenance review were evaluated. All six measures were endorsed. four measures will be reviewed as part of the fall 2019 cycle. Cancer Cancer care is complex and provided in multiple settings._hospitals, outpatient clinics, ambulatory infusion centers,. radiation oncology treatmentcenters, radiology departments, palliative and hospice care facilities-by multiple providers including surgeons, oncologists, nurses, pain management specialists, and sociai worl<ers. Due to the need for multiple care transitions that may at times require numerous care settings and providers, care coordination is vital, and quality measures thafaddress the value and efficiency of care for patients and their families are needed. NQF's current portfolio includes 27 endorsed measures that address prevalent forms of cancer; specifically, breast cancer, colon cancer, hematology, lung and thoradc cancer, and prostate cancer, During the full 2018. cycle. the Cancer Standing Committee evaluated two new measures and one measure undergoing maintenance review against NQF's. standard evaluation criteria. The Standing Committee r~ommended two measures for endorsement. One did not pass the NQF evaluation criterion due to the smatl sample size and complexity of the measure, and therefore was not recommended. The Consensus Standards Approval Committee (CSAC} deferred the endorsement decision of one measure back to the Standing Committee for reassessment in a future cycle. However, VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.024</GPH> 16 60194 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices during sJ!t.ing Zo19( there were !\O meas1.1ress1.1brnttted for review, ~tead, theCor:nr:nl~ had a mtegicwebmeetlngw pre\fiew the tWo· new measures and eight undergoing maintenanceri:!view. Nine mea:surt\$ are being re\fii:!wed as part of the fall 2019 cycle. i::~ CardiQwse1.1lardisease{C\tD).isa.significantburdel'!inthe.l£S., leaaingfuapproitiillatelyonein.fuur d9ths:.pet.year.15·CVOistheleadingcauseofdeathformenandwomenintheU;S;;16 Considering·the e~ofcatdio\lil$i';U.l.rrdlsease;. measures thatasseS$:tlinlcal c.:a~ perforntan® and patient outc:omes are critical toredoorig the negative impacts of CI/D, ~F'scutreot PQttfoli<> indudesS4endorsed measures addres$lttg pril'tlary ~venijonand $Creeningor the treatment and care of diseasesuctr as CQi'onary artery disease (CAD), heart failure (HF}1 ischemic vascular disease {IVD);acu~ myocardial infarction (AMl),anc:I hypertension. other endors~ measures assesssr:,eciflc,ttea:tments~dlagnostlc studies; or intet:venti0n:sSI.IChascardiatca~terization, perCl.ltaneous catheterlzatlonitit.erventiort{PCI), .Implantable clitdloverter-.deflbrillators.(ICl)s},•.cardiac imaging, and cardrac ti:!frabilita:tion, burlngthet;,IIW,A•cyeff.·the·cardiovastularstanding,tommifteeevaluatedfour·rneasures:onenew meas1.1re, and three ~asures undergoing maintenat1a:t ftWtew, All fourrnenuresWt'ite erulorsed, ·in.the spring2019 eycle;.theStanding Committee evaluated six measures undergoing mafntenance review againstNQF'sstandatd•~l!lluatJon criteria, All.s/xmeawtes wereerutorsed, Sevenmeasures are being reviewed as ·part ofthe fllll 2019:cycle. CostandEf/kletr!;'j: In 2017;.the 1,1.S;' national healtlre>tpenditures grew to:11;9 perce!ltof GOP, teacllirig $ts ttillioii,17 The prevalence of d,ronitdisease and life expectancy continue to: worsen in the.u;s, compared with other developed countries, despite extensive inveslment.18 Identifying opportunities to improve an upward ttend,:and understanding CQSt relatlve•tqquallty of tare and·outcomesarevltalfordeterminingwhether spending is proportionate to the healthcare goals we seek to athieve.19.2o NQPs current portfoliO includes 14 endorsed m~sures that adare:ss the value of healthcare servh:es through total cost ofcare and spending for treatment ofspecific conditions.for hospitals and providers. NO.F's Cost and.Efficiericy Project prll!larily focuses on evaluating costs and resourte use. measures and supports.NO.F's.efforts to provide guidance to the performance measurementetiterpri~onusingcost measures to u.nderstand efficiency and value. In the f!!H 2018 :c.ycls, the Cost and Efficiency Standing:Committee evaluated and endorsed one new measure~ During the spring 2019·cyele.• the Committee evaluated and endorsed 15measures. No measures are being revte\Ved as part of the fall 2019 cycle. Gerlelttlcs and Palllative care As of2Q18, there were an estimated. S0.9 ~illionindividu111s (15.6percenfortfie·u.s. popul,ttonI categorized within the 65-:anck>fder pOpulation, .a figure that is expected to.increase to 94; 7million by 2060?1 This population is affected bya variety of disabilities, limited function .and, for those noolnstltuti<malized, trave ~ .()rrnore chrontc.condition$,21•22 lmproV!ngbQth access to and quality of VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.025</GPH> 17 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60195 palliative and end-of-life care becomes more important with the. increasing number of aging Americans with chronic illnesses, disabilities, and functional limitations.13 NQF's current portfolio includes 35 endorsed measures addressing experience with care, care planning; pain management, dyspnea management, care preferences, and quality of care at the end of life. During the fall 2018 review cycle, the Geriatric and Palliative Care Standing Committee evaluated five measures undergoing maintenance revlew against NOF's measure evaluation criteria. All five were endorsed. During the spring 2-019 cycle, the committee reviewed and endorsed two new measures. Two measures are being reviewed as part of the fall 2019 cycle. Neurology Neurological conditions and injuries affect milfions of Americans each year, including patients, families, and caregivers, with costs increasing each year. According to a study published in the April 2017 issue of Annals of Neurology, the most common neurological diseases cost the United States $789 billion in 2014, and this figure is projected to grow as the elderly population doubles between 2011 and 2050.'4 Evaluation of performance measures will help guide quality improvements in care and treatment of neurological conditions. NQF's current portfolio includes 18 measures addressing stroke, dementia, and epilepsy. The portfolio contains 16 measures fur stroke, which lnclude six measures that are NQF-endorsed with reserve status, and two for demenl:ia. ln the fall 2018 cycle, there were no measures submitted forevaluation; however, the Neurology Committee did have a strategic discussion abouUhe portfolio of measures. During the sprimr2019 cycle, one maintenance eMeasure was evaluated, but the committee could not reach consensus due to lack of graded evidence, so the eMeasure was not endorsed. Three measures are being reviewed as part of the fall 2019 cycle. Patient Experience and Function As the healthcare paradigm evolves from one that identifies persons as passive recipients of care to one that empowers individuals to partidpate actively in tliein:are, effective engaged care must adapt readily to individual and family circumstances, as well as differing cultures, languages, disabilities, health literacy levels, and socioeconomic backgrounds. 25 The implementation of patient-centered measures is one of the most important approaches to ensuring that the healthcare Americans receive reflects the goals, preferences, and values of care recipients. NO.F's current portfolio includes 53 measures addressing concepts such as functional status, communication, shared decision making, care coordination, patient experience, and long-term services and supports. During the fail 2018 review cycle, the Jtatient Experience and Function Committee evaluated five new measures, Ali five measures were endorsed. During the spring 2019 cyde. 15 measures were reviewed, and all were endorsed. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.026</GPH> Two measures are being reviewed as part of.the fall 2019 cycle. 60196 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices pt,tlentSQfety Medical errors are estimated to cause hundreds of thou$linds of prevental>le deaths ellll:h year in the O.S.;i" Patient safety measurement and quality lmprovemenh:ffurts represenfone ofthe most successfufapplitatlons ofquality measurement; Theseeffotts.have•.m:tpeddrive subs.tanti.il reductions in patienuafety-related eventt particularly in. hospital$, Despite improvements, opportunities existto reduce harm and promote more effective and equitable care acrosssettings. NQF':s current portfolio Includes 62 measures on topics such as medication safefy, healthcare-associated lnfections; mortality1.faDs; pressure ulcers; and workforce and radiation safety. The f;i!!·2918 B!\!i!?WSMikl included six new and maintenam:e measures focused oo meditation m()flitorlng,111d review, surglcalsite and hospltal•acquii-ed infections, andnur..ei.' practfoe env1roomer1t All six measures wereendorlied.. Duilogthe spring 2019 cycle, the PatienfSafefy Comfoittee evaluated 11 measures, of which, ninfl! measl.lfesv.,ere endorsed, one was withdrawn by the measure developer following the comml~ee'i.evclfuatlon, and one was ni:>t re.c:ommended for ehdqrsemeri.t l:iecallSe.itdid not. pass the performance gap subcriterion. Ouringlhese cycles, the PatienfSafety Committee also explored·harmonizatklri of medication re:view.andreconcilic1tionmiMsutes, :an area. with.considerable variation of specifications; NQF summarized and analyze<! keyslmllarltlei.and differences ofthese measures. Conversations among the Committee members and developers resulted iri recommendations highlighting .keydpportunlties fur aligomentand the need fQl' stanciardlz:eddefinitions. Fqur 1neas'ures are being reviewed as part pf the falli019 cycle, PerlilotalandWo,mm's Health Perlnatai healtln:are accounts for. the largestcexpendlturein 1./.S: hec1lthcate, yet the lJ.S. continues to rank lastin maternal outoornes.•1 Hec1Jthcare disparities playa large role, as there are vast differences in care among different racial and ethnic groups regarding reproductive and peri'1atalhealthcare and outcomes;2' This is a major concern fut women, mothers, babiei., and the provideB who care fur•thern~ and a()COrdingly, itls important for quality measurementz9fe NQF's i':i.lrrent portfolio ini':ludes 18 endorsed measurei. ori·reprodtictive health,· pregrianey; ·tabofand delivery, postpartum care for newborns, andchildblrth-related Issues for women; NQ.F did not receive measures for the fall 2'018 cycle. Instead, the Perinatal and Women's Health Commit\ee held. sl:t,ltegic web meetings to discuss yarious high-level coru:eptsof perinatafhealth inciudirigpredlctorsof hospitalsatisfaction·1n childbirth! person.-centeredmaternity care;. challenges In perinatal and women's health measure development; and measure gaps in women's health within the fl!QF portf.i;1lio. Dl.lrlng themrf os '91.2 mtt; the committee reviewed Ofllii new mi$sure, whlchw;ts ultimately not endorsed as itdid not pass the Scientific Methods Panel review. Therefore, the Committee had a .strategic web meeting to discuss mea.surementfor maternal morbidity and mortality a(ldgaps in.Women's nealthrne.isu.res (nQnperirlatal arid. reproductive health measures}; two measulJ!S are being reviewed·as Part ofthe fall 20'.l.9cycle! Pntwntlon·andPopulathm•Health Effortstoimprove·thehealtham:iwell~being(lfindividualsan.dpoJ>Ulationsiiavel!Xl)andedfrQtn traditional medical care to ititeNention-balied health prevention, such as smoki,:ig cessation programs art<em so<;1afdeterm1tn1rits ()fhealth ($DOH).31 13oth med.i<:al care and SDQH influence health outccm'ia; VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.027</GPH> 19 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60197 therefore, performance. measurement is necessary to assess whether healthcare stakeholders are using strategies to increase prevention and improve population health. NQF's current portfolio includes 36emforsed measures that address immunization, pediatric dentistry, weight and body mass index, community-level indicators of health and disease, and primary prevention and/or screening. During the fall 2018 review cycle, the Prevention and Population Health Committee evaluated three measures undergoing maintenance review, All three were endorsed. During the spring cycle 2019. NQF did not receive any measures. Instead, the committee had a strategic discussion on defining value-based care for population health measurement. Three measures are being reviewed as part of the fall 2019 cycle. Primary Care and Chrome Illness Chronic disease affects one in 10 Americans and continues to be the leading cause of morbidity and mortality among. 32 Annual costs for chronic diseases such as glaucoma, rheumatoid arthritis, and hepatitis C are at $5.8 billion, $19.3 billion~ and $6.5 billion, respedively. 3'->·35 Primary care and chronic illness management are crucial to prevent other health concerns, and therefore must be consldered in healthcare services to reduce disease burden and healthcare costs. NQF's current portfolio includes 47 measures addressing areas on nonsurgical eye or ear, nose, and throat conditions, diabetes care, osteoporosis, HIV, hepatitis, rheumatoid arthritis, gout, asthma, chronic obstructive pulmonary disease (COPD), and acute bronchitis; During the fall 2018 review cycle. the Primary Care and Chronic Illness Committee evaluated two measures against NQF's evaluation criteria. One is a new measure, and one is undergoing maintenance review. Both measures were endorsed. During the spring 2019 review cyde. the Committee evaluated 10 measures (five new measures and five undergoing maintenance review). Following Committee evaluation, six measures were endorsed, consensus was not reached on two measures, and two measures were not recommended for endorsement, as they both did not pass the validity criterion. Six measures are being reviewed as part of the fall 2019 cycle. Renal Renal disease is a leading cause of death and morbidity in the U.S. An estimated 30 million American adults {15 percent of the population) have chronic kidney disease (CKO}, which is associated with premature mortality, decreased qUafity of life, and increased healthcare costs. left untreated, CKD can result in end-stage renal disease (ESRO}, which afflicts over 700,000 people in the US. and is the only chronic disease covered by Medicare for people under the age of6S, 36•37 NQF's current portfolio includes 20 endorsed measures addressing dialysis monitoring, hemodialysis, peritoneal dialysis, as well as patient safety. No measures were submitted for review during the fail 2018_ revkw cycle. During the spring.2019.revlew .cycle, the Renal Committee evaluated five measures undergoing maintenance review that focused on adult peritoneal dialysis quality or pediatric dialysis quality. AU five measures were endorsed. One measure. is being reviewed as part of the fall 2019 cycle; the maintenance reviews of several other measures were deferred to a subsequent cycle at the developer's request VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.028</GPH> 20 60198 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Surgery In 2014; there were 17.2 million hospital visits that included at least one surgery, with over half occurring in a hospital-owned ambulatory surgicaf center.33 Ambulatory surgeries have increased over time asa result of less invasive surgical techniques, patient conveniences {e.g., less time spent undergoing a procedure),and lower costs'.39•40 There are risks associated with-ambulatory surgeries, and with the continued growth in the outpatient surgery market, assessing the quality of the services provided holds great importance. NQF's current portfolio includes 65 endorsed surgery measures~ one of its largest portfolios. These measures address cardiac, vascular, orthopedic, urologic, and gynecologicsurgeri~ and iildude measures for adult and child surgeries as welt as surgeries for congenital anomalies. The portfolio also includes measures of perioperative safety, care COQrdination, and a range ofother dinical or procedural subtopics. During the fall 2018 review cycle. the Surgery Committee evaluated 15 measures undergoing maintenance, All 15 were endorsed. During the spring 2019 review cycle, the committee evaluated 11 measures. Of those, SIX measures were endorsed. Two measures are being reviewed as part of the fall 2019 cycle; V. Stakeholder Recommendations onQualityand Efficiency Measures and National Priorities Section11390(bXSXAlvi)o/the SocialSecurityActrequires the aiEw include in this report a description of annual attivJties related to multistakehalder groupinput on the selection a/qtialit.y and efficiency measuresfrom among: (i} sui::h measures that have been eooorsed bythe entlty; arKI (ii},.. [that} are used or proposed to be used by the Secretary for the collection or reporting ofquality orKI efficiency measures. Additionally, it requires that this report describe matters related to multistakeholderinput on national priorities/or improvement in population health arKI in deliveryo/hea/th care services for consideration under the National Quality Strategy. Measure Applications Partnership Under section 18.!10.4 of the Act, HHS i's required to establish a pre-roJemaking process under which a consensus-based entity (currently NQFJ would convell(! multistakehalder groups to provide input to the Secretary on the selection of qualityaooejfk:iency measuresJot use in certain federal programs. The h'st ofquality and efficiency measures HHS is considering for selection is to be publicly published no later thon December1 of each year. No later than February 1 ofeach year, the consensus-liased entity is to report the input ofthe multistakehalder groups, which will be considered by HHS in the selection of qualityandefjidency measures, NQFconvenes the Measure Applications Partnership (MAf>jfo provide guidance on the use of performance measures in federal healthcare quality programs; MAP makes these recommendations through its pre-rulemaking process that enables a multistakeholder dialogue to assess measurement priorities for these programs. MAP includes representation from both the public and private sectors, andindudes patients, clinicians, providers, purchasers, and payers. MAP reviews measures that CMS is considering implementing and provides guidance on their acceptability and value to stakeholders. MAP was first convened in 2011 and completed its ninth year of review in 2019. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.029</GPH> 21 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60199 MAP comprises three setting-specific workgroups {Hospital, dinician, and Post-Acute/Long-Term Care}, one population-specific workgroup (Rural Health), and a Coordinating Committee that provides strategic guidance and oversight to the workgroups and recommendations. MAP members represent users of performance measures and over 135 healthcare leaders from 90 organizations. MAP conducts its prerulemaking work in an open and transparent process. More specifically, the list of Measures Under Consideration {MUC) is posted publicly, MAP's deliberations are open to the public, and the process allows for the submission of both oral and written public comments to inform the deliberations. MAP aims to provide input to CMS that ensures the measures used in federal programs are meaningful to all stakeholders. MAP focuses on recommending measures that: 1) empower patients to be active healthcare consumers and support their decision making; 2) are not overly burdensome on providers; and 3} can support the transition to a system that pays on value of care. MAP strives to recommend measures that will improve quality for all Americans and ensure that the transition to VBP and AP Ms improves care and access while reducing costs for alt MAP 2019 Pre-Rulemak!ng Recommendations MAP published the findings of its 2018-2019 pre-rule ma king deliberations in a series o f ~ delivered in February and March 2019. MAP made recommendations on 39 measures under consideration for 10 CMS quality reporting and value-based payment programs covering ambulatory, acute, and post-acute/long-term care settings. A summary ofthis work is provided below. Additionally, MAP began its 2019-2020 pre-rulemakingdeliberations in November 2019 to provide input on 17 measures under consideration for nine CMS programs. Reports on this work are expected in February and March 2020. MAP's pre-rulemaking recommendations reflect its Measure Selection Criteria and how well MAP believes a measure under consideration fits the needs of the specified program. The MAP Measure Selection Criteria are designed to demonstrate the characteristics of an ideal set of performance measures. MAP emphasizes the need for evidence-based, scientifically sound measures while minimizing the burden of measurement by promoting alignment and ensuring measures are feasible. MAP also promotes person-centered measurement, alignment across the public and private sectors, and the reduction of healthcare disparities. MAP Rural Health Workgroup In the fall of 2019, NQF reconvened the MAP Rural Health Workgroup to provide input into the CMS annual pre-rulemaking process, as recommended in the 2015 NQF report on rural health, The Workgroup comprises experts in rural health, frontline healthcare providers who serve in rural and frontier areas-including tribal areas, and patients from these areas. The role of the workgroup is to provide rural perspectives on measure selection for CMS program use, including 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 workgroup reviewed and discussed the MUCs for various CMS quality programs. NQF provided a written summary of the workgroup's feedback to the Hospital, Clinician, and PAC/LTC Workgroups to aid in their review of the measures. A liaison from the Rural Workgroup attended each of the setting-specific workgroup meetings to provide additional input and represent the rural perspective. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.030</GPH> 22 60200 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices MAP Clinician Workgroup The MAP Clinician Workgroup reviewed 26 MUCs from the 2018 list for two programs addressing clinician or accountable care organization (ACO} measurement, making the following recommendations organized by program. Merit-Based Incentive Payment System - MIPS was established by section lOl(c) of MACRA. MIPS is a pay-for-performance program for eligible clinicians. MIPS applies positive, neutral, and negative payment adjustments based on performance in four categories: quality, cost, promoting interoperability, and improvement activities. MIPS is one of two tracks in the Quality Payment Program (QPP). MAP reviewed 21 measures for MIPS and made the following recommendations: • ~ - MAP conditionally supported 17 measures pending receipt of NQF endorsement, including 11 measures that promote affordability of care by assessing healthcare costs or appropriate use. • No Support with Potential Mitigation. MAP did not support with potential for mitigation three measures under consideration. • No Support. There was one measure considered that MAP did not support fur rulemaking. In addition to the measure recommendations, MAP noted the need to reduce healthcare costs but cautioned that measures must be accurate and actionable. MAP noted that CMS and the NQF Cost and Efficiency Standing Committee should continue to evaluate the risk-adjustment model and attribution models for appropriateness and ensure that cost measures truly address factors within a clinician's control. MAP also emphasized the importance of completing measure testing at the clinician level of analysis prior to implementation in the MIPS program. Measures for MIPS on the 2018 MUC list were under consideration for potential implementation in the 2020 measure set affecting the 2022 payment year and future years. Medicare Shared Savings Program (SSP)- Section 3022 of the Affordable Care Act (ACA) created the Medicare Shared Savings Program. The Shared Savings Program creates an opportunity for providers and suppliers to create an ACO. An ACO is responsible for the cost and quality of the care for an assigned population of Medicare fee-for-service beneficiaries. For ACOs entering the program in 2018 or 2019, there were multiple participation options: (Track 1) one-sided risk model (ACOs do not assume risk fur shared losses); (Track l+ Model) two-slded risk model (ACOs assume limited losses [less than other tracksl); (Track 2) two-sided risk model (sharing of savings and losses, with the possibility of receiving a greater portion of any savings than track 1 ACOs); and (Track 3/ENHANCE0 track) two-sided risk model (sharing of savings and losses with greater risk than Track 2, but opportunity to share in the greatest portion of savings if successful). SSP aims to promote accountability for a patient population, care coordination, and the use of high quality and efficient services, In its 2018-2019 pre-rulemaking work, MAP considered five measures for SSP and made the following recommendations: • ~ - MAP conditionally supported three measures, two of which address opioid overuse. MAP noted the importance of these measures given the current public health opioid crisis, MAP also conditionally supported Adult Immunization Status (also considered for MIPS) VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.031</GPH> 23 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60201 pending NQF endorsement. This measure has been proposed by CMS for addition to the SSP measure set. • No Support. MAP did not support adding two measures for use in SSP: Initial Opioid Prescription Compliant with CDC Recommendations and Use of Opioids from Multiple Providers and at High Dosage in Persons without Cancer. MAP did not consider the first measure to be adequately specified for the ACO level, and MAP considered the second to be duplicative of the opioid measures already recommended. Key Themes from the Pre-Rulemaking Review Process - One overarching theme of MAP's pre• rulemaking recommendations for measures in the MIPS and the SSP emphasized appropriate attribution and level of analysis for the measures considered. MAP recognized the need to appropriately assign patients and their outcomes to the appropriate accountable unit (e.g., a clinician, a group of clinicians, an ACO) for performance measures that are incorporated into payment programs. MAP members noted that measures that give actionable information are more likely to be acceptable to clinicians. MAC AA requires that cost measures implemented in MIPS include consideration of clinically coherent groups; specifically, patient condition groups or care episode groups. Through its pre-rulemaking work, MAP emphasized the importance of aligning cost and quality measures to truly understand efficiency while protecting against potential negative unintended consequences of cost measures, such as the stinting of care or the provision of lower quality care. MAP provided several recommendations to safeguard quality of care while measuring the cost of the care provided. These follow below: • first, MAP recommended that measures that serve as a balance to cost-of-care measures be incorporated into the program when feasible. These balancing measures could include clinical quality measures, efficiency measures, access measures, and appropriate use measures, • ln addition to focusing on the quality of the care provided, MAP stated that CMS should continually monitor for signs of inequities of care. MAP specifically noted a concern for stinting on care, which would disproportionately impact higher-risk patients, • Relatedly, MAP recommended clinical and social risk-adjustment models to incentivize providers who demonstrate expertise when dealing with increased risk. • lastiy, MAP commented on the need to link clinician behaviors to cost. MAP members appreciated that CMS used TEPs to determine which components of cost an assessed clinician or group can control. MAP reinforced the need for this process to be transparent and understandable to clinicians who are being evaluated. MAP Hospital Workgroup The MAP Hospital Workgroup reviewed four MUCs from the 2018 list for two hospital and other setting• specific programs, making the following recommendations. Hospital Inpatient Quality Reporting (IQR) Program• The Hospital Inpatient Quality Reporting (IQR) Program is a pay-for-reporting program that requires hospitals paid under the Inpatient Prospective Payment System (fPPS) to report on various measures, including process, structure, outcome, and patient perspective on care, efficiency, and costs-of-care measures. The applicable percentage increase for hospitals that do not participate or meet program requirements are reduced by one-quarter. The program has two goals: 1) to provide an incentive for hospitals to report quality information about their services; and 2) to provide consumers information about hospital quality so they can make informed choices about their care. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.032</GPH> 24 60202 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices MAP reviewed three measures under consideration for the IQR Program and offered conditional support for all three pending NQF review and endorsement. MAP did not review any measures for the Medicare and Medicaid EHR Promoting Interoperability Program for Eligible Hospitals and Critical Assess Hospitals for endorsement. PPS.Exempt Cancer Hospital Quality Reporting Program· The Prospective Payment System (PPS)Exempt Cancer Hospital Quality Reporting (PCHQR) Program Isa voluntary quality reporting program for PPS-exempt cancer hospitals. In its 2018-2019 pre-rulemaking deliberations, MAP reviewed one measure under consideration for the PCHQR program, Surgical Treatment Complications for Localized Prostate Cancer. MAP did not support the measure for rulemaking with potential for mitigation if problems with the measure specifications are unresolved. Key Themes from the Pre-Rulemaklng Review Process• The MAP Hospital Workgroup noted an increasing need to align the measures included in the various hospital and setting-specific programs. Providers are performing a growing number of surgeries and/or procedures across the various settings that traditionally occurred in the inpatient setting (i.e., hospital operating room). MAP recognized that patients and their families might face challenges in distinguishing between inpatient and outpatient services while making informed choices about their care. MAP also noted CMS' focus on minimizing the duplication of measures across programs while focusing on measures in high-priority areas. MAP noted the importance of providing patient-focused care that aligns with patient and family preferences, and recommended thatfuture high-priority measures include patient· and family-focused care that aligns with the patient's overall condition, goals of care, and preferences. MAP PAC/LTC Workgroup MAP reviewed nine measures under consideration from the 2018 list for five setting-specific federal programs addressing post-acute care (PAC) and long-term care (LTC), making the following recommendations. Skilled Nursing Facility Quality Reporting Program• The Skilled Nursing Facility Quality Reporting Program (SNF QRP) is a pay-for-reporting program that applies to free-standing SNFs, SNFs affiliated with acute care facilities, and all noncritical access hospital swing-bed rural hospitals. SNFs that do not submit the required data with respect to a fiscal year are subject to a 2 percent reduction in their annual payment rates for the fiscal year. MAP reviewed and c.onditionally supported two measures under consideration for the SNF QRP, pending NQF endorsement: Transfer of Heal'th Information to Patient-Post-Acute Care and Transfer of Health Information to Provider-Post-Acute Care. The workgroup noted that both measures could help improve the transfer of information about a patient's medication, an important aspect of care transitions. Better care transitions could improve patient outcomes, reduce complications, and lessen the risk of hospital admissions or readmissions. Additionally, the measures would meet the Improving Medicare Post-Acute Care Transformation (IMPACT) Act requirement that protects clients' choice and streamline service provision, 41 address PAC/LTC core concepts not currently included in the program measure set, and promote alignment across programs. Inpatient Rehabilitation Facility Quality Reporting Program (IRF QRP) · The Inpatient Rehabilitation Facility Quality Reporting Program (IRF QRP) was established under section 3004 of the ACA. This program applies to all !RF settings that receive payment under the lRF PPS including lRF hospitals, IRF units that are co-located with affiliated acute care facilities, and IRF units affiliated with CAHs. Under this VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.033</GPH> 25 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60203 program, IRF providers must submit quality reporting data from sources such as Medicare fee--forservice FFS Oaims that pay providers separately for each service,42 Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network jNHSN) data submissions, and the !RF-Patient Assessment Instrument (PAI), or be subject to a 2 percent reduction in the applicable annual payment update. MAP reviewed and conditionally supported the same two measures under consideration for the IRF QRP. Again, MAP noted that these measures address an IMPACT Act requirement for the IRF QRP and address an important patient safety issue. MAP recognized that IRFs may see more acute patients than other PAC/LTC settings, and suggested congruence with the definition of medication lists for acute care. Long-Term Care Hospital Quality Reporting Program (LTCH QRP) • The long-Term Care Hospital Quality Reporting Program (LTCH QRP) was established under section 3004 of the ACA. Under this program, LTCH providers must submit quality reporting data from sources such as Medicare fFS Claims, the CDC NHSN data submissions, and the LTCH Continuity Assessment Record and Evaluation Data Sets (LCDS), or be subject to a 2 percent reduction in the applicable annual payment update. MAP reviewed and conditionally supported the same two measures discussed in the previous sections for the LTCH QRP. Home Health Quality Reporting Program (HH QRP)- The Home Health Quality Reporting Program (HH QRP) was established in accordance with Section 1895 of the Social Security Act. Under this program, home health agencies (HHAs) must submit quality reporting data from sources such as Medicare FFS Claims, the Outcome and Assessment Information Set (OASIS), and the Home Health Care Consumer Assessment of Healthcare Providers and Systems survey (HH CAHPS"'), or be subject to a 2 percent reduction in the annual PPS increase factor. MAP reviewed and conditionally supported the same two measures discussed in the previous sections for this program as well. Hospice Quality Reporting Program (HQRP) • The Hospice Quality Reporting Program (HQRP) was established under section 3004 of the ACA. The HQRP applies to all hospices, regardless of setting. Under this program, hospice providers must submit quality reporting data from sources such as the Hospice Item Set (HIS) data collection tool and the Hospice Consumer Assessment of Healthcare Providers and Systems survey (CAHPS Hospice survey), or be subject to a 2 percent reduction in the applicable annual payment update. MAP reviewed one measure under consideration for the HQRP: Transitions from Hospice Care, Followed by Death or Acute Care. MAP did not support this measure for mlemaking as currently specified with a potential for mitigation. MAP recommended that the measure developer reconsider the exclusion criteria for the measure. Specifically, the developer should review the exclusion for Medicare Advantage patients, as this may be excluding too many patients. Additionally, the developer should consider adding an exclusion to allow for patient choice. MAP recognized the need to address a potentially serious quality problem for patients if they are inappropriately discharged from hospice. MAP noted that transitions of care at the end of a person's life can be associated with adverse health outcomes, lower patient and family satisfaction, and higher costs. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.034</GPH> 26 60204 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Key Themes from the Pre-Rulemaklng Review Process - MAP noted that patients requiring post-acute and long-term care are clinically complex and may frequently transition across sites of care. As such, quality of care is an essential issue for PAC and LTC patients. Performance measures are vital to understanding healthcare quality, but measures must be meaningful and actionable if they are to drive true improvement. MAP highlighted that patients who receive care from PAC and LTC providers frequently transition between sites of care. Patients may move among their home, the hospital, and PAC or LTC settings as their health and functional status change. Improving care coordination and the quality of care transitions is essential to improving post-acute and long-term care. MAP members appreciated that the measures allow for the current technology limitations in PAC/LTC settings by allowing for multiple modes of transmission of the required medication list. MAP members recommended that CMS ensure that the measures appropriately address situations such as a patient leaving against medical advice or a transfer ta an emergency department. MAP also noted that the measures should ensure a timely transfer of information so that patients and receiving providers can ensure that they have the medications and equipment needed for a safe and effective transition of care. MAP stressed the importance of ensuring that measures produce meaningful information for all stakeholders. Measures should focus on areas that are meaningful ta patients as well as clinicians and providers. MAP emphasized a need for measures that are person-centered and address aspects of care that are most meaningful to patients and families. MAP members noted the need to engage patients and families into quality improvement efforts. 2019 Measurement Guidance for Medicaid Scorecard Medicaid and CHIP cover 73 million lives, or roughly 23 percent of the U.S. population. Nearly 51 percent ofindividuals enrolled in Medicaid are children, and approximately two-thirds of women enrolled in Medicaid are in their child-bearing years. Both programs are responsible for delivering healthcare to a significant proportion of Americans, and especially to those who are among the most economically and medically vulnerable, like children from low-income households, low-income elderly, and persons with marked disability. Many federal efforts and programs promote quality of care and health for the Medicaid population. In June 2018, CMS released its first version of the Medicaid and CHIP (MAC) Scorecard. The Scorecard is designed to increase the public's access to performance data for the MAC programs including health outcomes of enrollees. The Scorecard has three pillars, each consisting of a set of measures selected to reflect the performance of the units that support the MAC programs; state health system performance, state administrative accountability, and federal administrative accountability. NQF convened the multistakeholder MAC Scorecard Committee, charged with providing input on the pre populated Scorecard version 1,0 for the state health system performance pillar. Specifically, the Committee was tasked with determining which measures should be recommended for addition to-and removal from-the current version ofthe Scorecard. In an effort to facilitate adoption and implementation of the Scorecard, the state health system pillar draws on measures from the Medicaid Adult and Child Core Sets. This pillar is designed to examine how states serve MAC beneficiaries throughout different measurement domains including, but not limited to, Communicating and Coordinating Care, Reducing Harm Caused in Care Delivery, and Making Care Affordable. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.035</GPH> 27 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60205 The Committee first evaluated the current measures in the state health system performance pillar of the Scorecard to identify high need and gap areas such as behavioral health. Subsequently, the Committee assessed measures in the 2018 Adult and Child Core-Sets to identify potential measures to recommend for addition to or potential removal from the Scorecard in future iterations. During measure discussions, Committee members considered many factors, including whether measures address the diverse health needs of the Medicaid population and the most vulnerable among them, drive improvements in healthcare quality, and reduce or minimize reporting burden. Committee members considered measures for addition that directly address the usefulness of measure implementation and reporting. Given the recency of the Scorecard's creation, the Committee also considered the application of measures in the Scorecard and the consequences or implications of accountability; Ultimately, the Committee recommended one measure for removal, Use ofMultfple ConcurrentAntipsychatics: Ages 117, and the addition of four measures listed in order of priority. Rank 1 NQF Number and Measure Title 1448 Developmental Screening in the First Three Years oflife 2 3 1768 Pl.in All-Cause Readmissions 0038 Childhood Immunization Status 1879 Adherence to Antipsychotic Medications for Individuals with Schizophrenia (SAA-AO} These measures would strengthen the measure set by promoting measurement of high-priority quality issues and addressing chlldhood immunization, preventive care for children, and behavioral health. At the request of CMS, additions were limited to the Core Sets only. The MAC Scorecard Committee also discussed the future direction ofthe Scorecard and provided guidance on future measure set curation, as well as best practices to promote reporting. The Committee emphasized the importance of harnessing performance measurement results to drive health system change and improvements in care delivery. In order to promote measure reporting, the Committee suggested that states implement payment incentives or leverage value-based payment models in the Scorecard's early stages of development. Given the new and iterative nature of the Scorecard, the Committee encouraged the Center for Medicaid and CHIP Services {CMCS} to structure the Scorecard's evolution in two phases focused on refinement and feedback. In the short term, the Committee emphasized the importance of refinement to optimize the Scorecard measure set. For the long term, the Committee recommended that CMCS solicit and leverage continuous feedback and performance data from states to prioritize use of measures that have the greatest utility. The final report, Strengthening the Medicaid and CHIP (MAC} Scorecard, was published in August 2019. VI. Gaps in Endorsed Quality and Efficiency Measures Under section 1890(bX5)(A)(iv) of the Act, the entity is required to describe in the annual report gaps in endorsed quality and efficiency measures, induding measures within priority areas identJJied 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. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.036</GPH> 28 60206 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Gaps Identified in 2019 Completed Projects During their deliberatiom,, 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 2019 can be found in Measure Applications Partnership: Identifying and Filling Measure Gaps In addition to its role of recommending measures for potential inclusion into federat programs, MAP also provides guidance on identified measurement gaps at tire individual federal program level. In its 2018-2019 pre-rulemaking deliberations, MAP specifically addressed the high-priority domaiMCMS identified in each of the federal programsfor future measure consideratlon. A list of gaps identified by CMS program can be found in Appendix H. VII. Gaps in Evidence and Targeted Research Needs Undersect1001890(bXS}(A)M of the Act, the entityis required to describe areas in which evidence is insufficient: to support endo1Sement ofquality and efficiency measures in priority areas identified by the Secretary under the National Quality Strategy and where targeted research may address such gaps. NQF undertook several projects in 2019 to create needed strategic approaches, or frameworks, to measure quality in areas critical to improving health and healthcare for the nation but fur which quallty measures are too few, underdeveloped, or nonexistent. A measurement framework is a conceptual model for organizing ideas that are important to measure for a topic area and fur describing how measurementsliould.take place (i,e., whose performance should be measured,.care settings where measurement is 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 gaps in important healthcare areas, underpin future efforts to improve quality through metrics, and ensure safer, patient-centered, costeffective care that reflects current science and evidence. NQF began projects to create strategic measurement frameworks for assessing population-based trauma outcomes, healthcare system readiness, chief complaint-based quality for emergency care, common formats for patient safety, person-centered planning and practice, measure feedback loe)p, patient-reported outcomes, EHR data quality, diagnostic error, and maternal morbidity and mortality. Population-Based Trauma Outcomes Intentional and nonintentional injuries resulting in trauma are the third~leadlng cause of death in the U.S.,'B Traumatic injuries-that ls, the set of all physical injuries of sudden onset and severity that require immediate medical attention-result in 39 million emergency visits and 12.3 million hospital admissions every year. Such injuries were associated with $670 billion in medical expenses in 2013. «As. Fortunately, major progress has been made in trauma care. Yet, even with the imprO\lements, trauma injury has a significant impact on public health, and performance of trauma systems requires increased attention. However, there.are rew measures in existence or implemented to improve trauma care quality. 43 Performance measures allow for assessment of trauma care and increased focus on improvement efforts with respect to quality ofcare. l'erformance measures may also help in addressing VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.037</GPH> 29 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60207 kev.~me!l•\Vlthl!l~urn.i ~er~·.iSc ~l!tyof life,.~ttil b~™1sttitus, .rt!lla.l;>ilitatiorl, .tn!f k,>,ss.of life. !!!!;~°!~!:e:::~:~::::~u:::::~:::::::'!!.~~==!1. ·tra9rnay,,.i,;not¢~vely.i~re~bv~•i::qinm11:tee~wl1S.i'd<n~gecll'IS•<1.n·1rnportaritfon:s-, :==~~i:::r!~!:=~~~w:=:::::!w::::::r:::donof· ::;;s:::!~~;:;e::~==:~7-~=:.r=:-=fi~t:;:rid prevention: of'triiumaJand 1ssubdomains'mr population-based trauma outcornes,. llelow 1s:a table of •~ l:4ot:n.ii~1t11d st1bd~rn;1i~~ :®$:J)r()~ · ~~7~:;;;;;;:~~=;::::;;~:mitteeasanfolormation Healthaii~~R-'irie5l· . .. ·~=!:~::::::::::::::::::t!:::~::~:~:pi~ ·slibstaritiaf·progress,complex•chalfenges:~st;•and.preparedriesseffi:lrtsmay·r19tsuffii:e. ·FQf·example, :5="=.T2':r~::2=:.T ·:\:;;~~!?:;;;!:=::~~::fe!;J::;::;:::!lv!::!~:or emergency(~readlnen'!}, Thecuttent·iandscape'ofhe.tlthtare·systemreadtness-rne.tsiitem.eiit-indudescritk:al. and•.teievaof ·t:nettk;s:fcr pQbliche.lltha11dd~st1~llantt!'ptqgr.1ms,·There is;hol/1/f!!iferia lack ofqu1tllty.ind :":!1!~::::~!:n~~!!:'tve~::.~::::~1::;::=:t:rs~• th .~·1neplofirnprc,vins~~n-centerE!dcare,~hlt!;.•n4~t:effli;ieocy,~~-ofthis.prc,Jt!c;t·WII$ ·on rneasuremer\~~ft11~·more·#)mpreiie~•contept·of·readl~~o.dincludi(ig110tonly hQWa VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.038</GPH> 30 60208 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices healthcare system may prepare prior to an event, but also how it actually performs both during an event and after it ends. to.address these challenges, in 2-018, NQfconvened a muftistakeholder committee to provide input and guide the creation of a frameWork. The development of the. framework originated from the concept that readiness. exists at the inters~on of the four phases of emergency management: mitigation, preparedness, response, and recovery; The concept of readiness is a holistic concept that applies to all entities that deliver care (i.e., the healthcare system) within a particular community that is, or may be, affected by a disaster or emergency. With.this view of readiness in mind, the committee developed a set of guiding principles to define the key criteria when considering the measure concepts to guide their development into performance measures. Guiding prlnciples were then further divided into the subcategories of "the what," "the where," and "the how" to provide a primer oft.ictors that users should consider when applying this framework. An overarching subcategory of"why" was also created. Below is a table of the domains and subdomains for this project: Emergency management prowam, incident management, communications, healthcare system coordination, surge capacity, busineSSc continuity, population health management Using these domains and subdomains, NQF worked with the Readiness Committee to examine and develop measure concepts based on informationgathered from the literature and knowledge of each of the Committee members.They noted some challenges with moliirlg ffO!ll measure concepts to quality measures as requiring a concerted collaboration between healthcare entities, measure developers, and the federal government. The Committee emphasized the adoption of metrics related to readiness that could be deployed across various types of healthcare entitl'esand measure whether entities are actually ready to meet the needs of patients during a disaster or emergency. To that end, the Committee offered VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.039</GPH> ..31 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60209 several next steps focused on investment in the development of high-priority measures: developing a feasibility scale for healthcare entities to identify and determine capacities and capabilities for readiness efforts; better defined responsibilities across healthcare entities; and alignment between public and private stakeholders. T h e ~ for this project was published in June 2019. Chief Complaint-Based Quality for Emergency Care Emergency departments (EDs) have always played an important role in the delivery of acute, unscheduled care in the U.S., with nearly 145 million visits and more than one-quarter of all acute care visits. 48 The majority of ED care focuses on diagnosing and treating a patient's chief complaint rather than addressing a definitive diagnosis. A patient's chief complaint-patient-reported symptoms collected at the start of the visit-describes the most significant symptoms or signs of illness (e.g., chest pain, headache, fever, abdominal pa in, etc.) that caused the person to seek healthcare. Chief complaint data have various uses that facilitate and inform patient-centered care, decision support, disease surveillance, and quality measurement. However, the lack of standardization of information about chief complaints creates challenges for use cases that require aggregation of similar patients for quality measures or detecting disease outbreaks. Efforts to resolve the challenges with standardization of chief complaint data have been discussed for more than two decades. However, recent advancements in information technology (IT) and informatics may present solutions to several of the barriers-areas that have limited standardization. Researchers and informatidsts have developed several approaches and tools that can standardize chief complaints including classification systems, nomenclatures, ontologies, and IT-based tools. However, there is still no current guidance or consensus on how to navigate these approaches, understand their strengths and weaknesses, and select the best approaches and tools for a specific use case. In addition, there is a lack of standard nomenclature to define how chief complaints are organized, categorized, and assigned. further, a reliance 011 diagnosis-based administrative claims for quality measurement creates barriers to establishing valid and reliable patient feedback on the reason the patient came to the ED for care. Currently, there is no national guidance to overcome these barriers to using chief complaints in quality measurement for patients presenting to the ED. In fall 2018, NQF convened a multistakeholder Expert Panel to identify performance measures; measure concepts; and gaps in available performance measures, nomenclatures, and data sources related to chief complaints. Additionally, the Expert Panel provided suggestions for standardizing: 1) chief complaint-based nomenclature; and 2) existing assessments of the strengths and weaknesses of current data sources (e.g., existing clinical content standards, processed free text, EHRs} for developi~ either new eMeasures in this space, or new measures that incorporate patient perspectives. Ultimately, the Committee identified a total of 50 measures and 11 measure concepts based on symptom-based discharge diagnoses across 16 chief complaints or conditions, which included back pain, chest pain, head injury, abdominal pain, altered mental status, chest pain/shortness of breath, syncope, vaginal bleeding, substance use, neck pain, low back pain, sore throat, head trauma, seizure, suicidal ideation, and dizziness. This environmental scan provided a foundation for the development of the measurement framework. The Chief Complaint Measurement Framework provided a conceptual model for how chief complaint data can be used to measure quality in acute care settings like the ED. While it is not the focus of the VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.040</GPH> 32 60210 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices framework, the use of these data for public health surveillance is also represented. This framework relies on the implementation of a systematic approach for standardizing and aggregating chief complaint data and a key set ofterms, which indude defining: 1) chief complaint; 2) reason for visit; presenting problem; and 4) clinical.syndrome. Establishing these terms and definitions helped shape the ability to understand the relationship between the chief complaint, a standardized representation of the chief complaint (i.e., presenting problem), and a clinical syndrome, The measurement framework comprises 11 domains: • Patient-Reported Outcomes• • Effective Care/Appropriateness of Diagnostic Process • CostofCare • Diagnostic (Accuracy) Quality and Safety • Care Coordination • Shared Decision Making • Safety • Timeliness • Patient Experience • Utilization • Patient Outcomes The Committee also suggested strategies for promoting the implementation of the recommendations to enable widespread, standardized, and systematic collection of d1ref complaint data in the current emergency department and EHR fandscape. Recommendations centered on four key areas: 1} establishing a standard chief complaint vocabulary; 2) aggregating chief complaint data in the absence of a standard vocabulary; 3j engaging importantstakeholders to advance chief complaint-based measurement; and 4) data quality and implementing chief complaint-based measures. The final report for this project was published in June 2019. Common formats for Patient Safety The Common Formats for Patient Safety is a project that began in 2013 and is supported by AH RQ to obtain comments from stakeholders about the Common Formats authorized by the Patient Safety and Quality Improvement Act of 2005 {Patient Safety Act)" authorizes AHRQto designate Patient Safety Organizations (PSOs} that work with providers. The term "Common Formats" refers.to improving patient safety and healthcare quality. In order to support PSOs in reporting data in a standard way, AHRQ created "Common formats"-or the common definitions and reporting formats-that standardize the method fur healthcare providers and PSOs to collect and exchange information fur any patient safety event. The objectives of the Common Formats projects are to standardize patient safety event data collection, permit aggregation of collected data for pattern analysis, and learn about trends in patient safety concerns. AHRQfirst released Common formats in 2008 to support event reporting in hospitals • Patient-lu!ported Outcomes are defined as the stlltus of ll patient's health tondition,hat comes directly from the patient without interpretation. Patient Outcomes are defined as an.outcome of the patient as a result of care ln the EO {or similar setting). Patient Safety and Quality Improvement Act of :2005 Statue and Rule. https:l/www.hhs.gov/hipaa/forprpfessigpals(patiertt·safw,lstatutt;ang'Cl'ule{index. hlrnl• Pub IIshed June 10, 2017, Last accessed January 2()20. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.041</GPH> 33 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60211 and has since. developed Common Formats. for event reportlngwithln nursing homes and community pharmacies, as well as Common Formats for hospitll surveiltance. The Common Formats for specific care settings include hospitals, nursing homes~ community pharmacies and hospital surveillance. The Common Formats for eventreporting apply to all patient safety concerns, induding.incidents; near misses or close calls, and unsafe conditions programs. NQF, on behalf ofAH RO. coordinates a process annually to obtain comments from stakeholders about the Common Formats; In 2019, NQFcontinued to collect comments on all elements (including, but not limited to, device or medicaVsurgical supply, falls, medication or other substance, perinatal, surgery; and pressure injury) ofthe Common Formats, including the most recent release. Hospital Common .Formats Version 0.3 Beta. The public has an opportunity to comment on alJ elements of the Common Formats modules using commenting tools developed and maintained by NQf; An NQF Expert Panel reviewed the publ'ic comments and provided AHRQ feedback with the goal of improving the Common Formats modules and.the standardization of information. Person-Centered Planning and Practice Recent transformations in the healthcare and human services delivery systems have focused on performance measures across payers and providers to improve outcomes, experience of care, and population health, with the explicit goal of ini:reasing a person's "ownership'' of their health and healthcare serviceswithin their chosen community. However, there is neither a national quality measure set fur person-centered planning {PCP} nor a set of evidence-based strategies upon which to develop measures of PCP. About 21 million Americans are expected to be fwingwith multiple chronic conditions by 204Q; and many will require iong"'term services and supports {Li'Ss} in community and institutional settings.49 In an effort to address LTSS needs that are predicated on individuals' needs, preferences, goals, and. desires, NQF convened a committee of experts in 2019 with lived and professional experience in LTSS and with acute/primary/chronic care systems. The goal is to create a sustainable LTSS system where older.adults and people with disabilities have choice, control, and access to a full array of quality services that assure OPtimal outcomes including independence; good health; and quality of life. The aim of the committee was to provide a consensus-based view of multiple areas of PCP by addressing three concerns related to designing practice standards and competencies for.PCP. Through a consensus-building process, stakeholders representing a variety of diverse perspectives metthroughout the project to refine the current definition of PCP; develop a set of core competencies for performing PCP facilitation; make recommendations to HHS on systems characteristics that support PCP; condu.ct a scan that includes historical development of PCP in LTSSsystems; developa conceptual framework for PCP measurement; and create a research agenda for future PCP research. The first interim report representing the committee's efforts to date was made available for comment in November 2019. In this report, the committeeaddressed three key concerns related to designing practice standards and competencies for PCP. First, the committee proffered a functional, person-first definition of PCP. Second, the committee outlined a core set of competencies fur persons facilitating the planning process, including details of foundational skills, relational and communication skills, philosaphy, resource knowledge, and the policy and regulatory context of PCP. lastly, the committee VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.042</GPH> 34 60212 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices considered the systems characteristics that support PCP such as system-level processes, infrastructure, data, and resources, .along with guidance on how to maintain system-level person-centeredness. A future final report with committee feedback will be completed in July 2020. lt will address the history of PCP, a framework for quality measurement within PCP, and a research agenda to advance and promote PCP in long-term services and supports, which includes home and community-based services and institutional settings, such as nursing homes, and the interface with the acute/primary/chronic care systems. Measure Feedback Loop Collecting data on how quality measures are implemented and used in the field is critical for continuing to improve the quality measurement landscape. A measure feedback loop refers to the process by which information about measure performance from those who implement measures is relayed back to measure developers and multistakeholder standing committees who can then act on it. This information is vital to identifying opportunities for improvements to measure specifications, implementation guidance, and other aspects of the measure that may improve usability. While NQf receives some information from measure developers and measure stewards about the implementation and use of measures, this process could be strengthened and standardized. The Measure Feedback loop project aims to determine a workable process to elicit feedback from healthcare stakeholders on the experience of reporting measures used in Medicare quality reporting and value-based payment programs, including unintended consequences on providers, payers, consumers, caregivers, and other measure users. The project aims to enhance understanding of how measures actually perform in the real world, and about the risks and issues related to implementing measures in the field. In fall 2018, NQf began a new project to explore how to gather more information on the use of measures and how they affect patient care and organizations or providers that implement them. To accomplish this task, NQF convened a multistakeholder committee, conducted an environmental scan on measure performance data, collected existing consensus development process (CDP) use and usability information, and outlined options for piloting a measure feedback loop at NQF. The environmental sea n published in April 2019 identified four key aspects of a measure feedback loop: 1) feedback categories including examples; 2) key stakeholders from which measure feedback can be collected; 3) channels for exchanging feedback within NQF and CMS quality measurement processes and 4) tools for collecting and soliciting feedback. T h e ~ completed in June 2019, explored how CDP standing committees currently apply the usability and use criteria, current practices for collecting feedback, challenges associated with each of these practices, recommendations for improving them, and new potential approaches for collecting feedback. Ultimately, the recommendations centered on six key areas: 1) modifying the Usability and Use criteria and NQf measure submission form; 2) improving accessibility of commenting tools and opportunities to submit comments; 3) facilitating communication of feedback throughout the loop; 4) targeting outreach to key stakeholders; 5) classifying feedback into key domains; and 6) developing guidance for measure developers. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.043</GPH> 35 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60213 The mlot optigns rwort. oublished in November. 2019, recommended a number of strategies that have the potential to improve the ways in which NQF solicits, collects, facilitates, and shares feedback among healthcare stakeholders, In this report, NQF grouped the strategies and rated them against potential costsand benefits to facilitate prioritization of the strategies. With Committee guidance, NQF identified strategies that are low benefit, but high cost and so should not be prloritiied, and other .strategies that have high potential benefit whose implementation should be explored in future work. In 2020, NQF will develop an implementation plan report that details the recommended strategies and tactics, along with a proposed timeline for pHot-testing these approaches at NQF, Patient-Reported Outcomes Patient-reported outcomes (PROs) are Increasingly used· for various healthcare-related activities including care provision, performance measurement, and cl.inical, health services, and comparative effectiveness research. so,si They can be particularly valuable in improving the quality of care that is provided to patients and families, because PROs allow those aetually receiving cate to provide information on issues of import to them (e.g., symptoms, functional status, side effects, engagement in decision. making, goals of care, etc.).sH7 Despite the desire to use PROs In he;ilthcare, there is also re<:ognitlon that there are many challenges Inherent in their use-particularly related to selecting and collecting. PRO data. In 2012, HHS provided funding to NQF• to convene.a multistakeholder Expert Panel to conduct work that has since laid the groundwork for future PRO-PM development, testing, endorsement, and implementation. Specifically, the Panel provided guidance for selecting PROMs for use in performance measurement and articulated a pathway to move. from PROs to NO.F-endorsed PRO-PMs. As part of this work, the Panel also provided clarity to the field by defining "patient"-to include all persons, including patients, families, caregivers, and consumers more broadly-and defining and differentiating between PROs, defined and differentiated patient-reported outcomes {PROs), patient-reported outcome measures (PROMs), and patient-reported outcome-based performance measures {PRO-PMs). The Panel also provided.guidance for selecting PROMs for use In performance measurement and articulated a pathway to move from PROs to NQFcendorsed PRQ.PMs. As noted in the final repqrt that was published in December 2012 for that project, the wor<em "patient" indudes all persons, Including patients, families, caregivers, and consumers more broadly. The desire to use PROs in healthcare accompanies recognition of many challenges inherent in their use. For example, clinicians may be interested in using PRO data to guide the provision ofcare but need guidance in selecting which PROs and PROlllls to use to drive meaningful dinical interactions as well as for other downstream uses such as performance measurement Challenges pertaining to the implementation of PROs center on achieving buy-in from various stakeholders given the reallties of the data collection burden {e.g., workflow concerns by dini.cians and their staff, time and privacy issues for patients, if/how to incorporate data into EHRs, etc.), and ensuring that PRO data are of high quality. However, the collection of high quality PRO data depends, in part, on data sources (e,g,; self-report vs. proxy}, modes of administration (e.g., self• vs. interviewer-administered), and the method of administration (e.g., paper and pencil, telephone-assisted, electronic capture via tablets, etc.). s1 Other considerations influence the quality of PRO data as well, such as selection bias due to medical or social National Quality Forum. Patient-Reported O.utcomes in Performance Measurement. https:l/www.gualityforum.org/l>ublications/2012/l21PatientReported Outcomes in Performance Measurement.asqx. Last accessed February 2020. c VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.044</GPH> 36 60214 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices factors of the person providing the data, the extent of missing data, nonresponse bias, and overall response rates. In 2019, NQF convened a multistakeholder TEP to make recommendations for best practices to: 1) address challenges in PRO selection and data collection; 2) ensure PRO data quallty; and 3) apply the recommended best practices on PRO selection and implementation to use cases related to bums/trauma, heart failure, and joint replacement Application of these recommendations to the selected use cases allowed the TEP to pilot-test them for both acute and chronic conditions that often necessitate provision of care across settings and providers. NQF began by conducting an environmental scan to identify the challenges and promising approaches for: 1) selecting both PROs and PROMs; and 2) collecting high quality PRO data. The scan also identified both PRO-PMs and PROMs, the TEP making the distinction of PROs reflecting concepts (e.g., fatigue) that are reported by patients, whereas PROMs are the instruments used to elicit information from patients about those concepts. NQF identified a total of 81 PROMs relevant to bums, trauma, joint replacement, and heart failure, and generic PROMs that can be used for patients with these conditions. Overall, more of the identified PRO Ms addressed hea Ith-related quality of life, functional status, and symptoms/symptom burden. The 2019 TEP used the guiding principles for selecting PROMs identified by the 2012 Panel to select PROMs for the scan: psychometric soundness, person-centeredness, meaningfulness, amenable to change, and implementable. T h e ~ of the environmental scan was published in December 2019. The TEP will use the results of the environmenta I scan to spur discussion and identification of consensus recommendations for addressing challenges in the PRO selection and data collection and ensuring PRO data quality. The TEP also will use the results of the scan when applying these recommendations to use cases related to bums/ trauma, heart failure, and joint replacement. Electronic Health Record Data Quality EH Rs have become important data sources for measure development, because these data are captured in structured fields during patient care and are in wide use: 86 percent of office-based physicians use EHRs, as do 96 percent of acute care hospitals. 51 The use of EHR data is expected to reduce provider burden associated with collecting and reporting data for public reporting and value-based purchasing. 59•60 Furthermore, federal programs such as the Promoting interoperability Programs (also known as "meaningful use") promoted EHR use with the goal of improving care coordination and population health outcomes, as well as healthcare quality. While the increased use of EHRs holds promise for enhancing quality measurement, data quality varies considerably. Electronic clinical quality measures (eCQMs), which are specified to use EHRs as a source of data, were designed to enable automated reporting of measures using structured data. Combining eCQMs with structured EHR data has the potential to provide timely and accurate information pertinent to clinical decision support and facilitate monitoring of service utilization and health outcomes. 61 Currently, NQF has endorsed nearly 520 healthcare performance measures, with only 34 of these being eCQMs. Previous work by NQF has identified the ability of EHR systems to connect and exchange data as an important aspect of quality healthcare that is not currently fully realized. However, eCQMs and EHR data are not enough to enable automated quality measurement. eCQMs require that every single data element used within an eCQM measure specification be collected as a discrete structured data element. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.045</GPH> 37 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60215 EHR data are primarily designed to support patient care and billlng, not necessarily to capture data for secondary uses such as quality measurement.1,2 furthermore, while EHR use has led to an increase in the volume ofstructured data, EHR data are often not at the right level of completeness or granularity needed for effective use with eCQMs. 63 ln 2019, NQF began a project to identify best practices addressing EHR data quality issues_ impacting the use of EHR data in eCQMs and explore the challenges of assessing the quality of EHR data so that it can better support quality measurement, including automated measurement using eCQM specifications. Specifically, this project will identify the causes, nature, and extent of EHR-data quality issues, discuss and assess the impact that poor EHR-data quality has on scientific acceptability, use and usability, and feasibility, and make recommendations to HHS for best practices ln assessing and improving EHR data quality to improve the reliability and validity, use and usability, and feasibility of quality measure (including eCQMs) and increase the scientific acceptability and likelihood of NQF endorsement. To achieve this, NQF recruited a 21-member multistakeholder TEP to guide and provide input on the work. Additionally, NQF started an environmental scan to review the current landscape for assessing and maximizing structured EHR data quality, explore approaches currently used to mitigate data quality challenges, and identify data needed to support continued development and testing ofeCQMs. This scan will serve as a foundation for a final report that will be delivered to CMS in December 2020, and will encompass the TEP's discussions and recommendations for best practices in assessing and improving EHR data quality to improve the reliability and validity, use and usability, and feasibility of quality measures, including eCQMs; and likelihood for NQF endorsement. Reducing Diagnostic Error A 2015 report of the National Academies of Sciences, Engineering, and Medicine {NASEMJ, Improving Diagnosis in Health Care, defines diagnostic errors as the failure to establish or communicate an accurate and timely assessment of the patient's health problem. The report suggests these types of diagnostic errors contribute to nearly 10 percent of deaths each year and up to 17 percent of adverse hospitalevents;'•The NASEM Committee oti Diagnostic Error in Health Care suggested that most people will experience at least one diagnostic error in their lifetime. The delivery of high quality healthcare is predicated upon an accurate and timely diagnosis. Diagnostic errors persist through all.care settings and can result in physical, psychological, or financial repercussions for the patient. The NASEM Committee noted that there is a lack of effective measurement in this area, observing that "for a variety of reasons, diagnostic errors have been more challenging to measure than other quality or safety concepts."65 In follow-up to the NASEM report, NQF, with funding from HHS, d convened a multistakeholder expert committee in 2016 to develop a conceptual framework for measuring diagnostic quality and safety, to identify gaps in measurement of diagnostic quality and safety, and to identify priorities for future measure development. As part of this project, which resulted in the 2017 report Improving Diagnostic -=="'-"=-==.., NQf engaged stakeholders from across tile healthcare spectrum to explore the complex intersection of issues related to diagnosis and reducing diagnostic harm. 66 •CDC.Reproductive Health. https://www.cdc.gov/reproductivehealth/indeK.html. Published December 6, 2019. La.st accesiied January. 2.02.0. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.046</GPH> 38 60216 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices In 2019, NQf convened a new multistakeholder expert committee to revisit and build on the work of the former Diagnostic Quality and Safety Committee. The new expert committee reviewed the 2017 measurement framework and environmental scan in light ofthe new literature published to support the activities of improving diagnostic quality and safety. Specifically, this Committee reviewed one domain {Diagnostic Process and Outcomes) of the 2017 measurement framework and updated or modified the subdomains. In addition, the Committee identified any high-priority measures, measure concepts, current performance measures, and areas for future measure development that have emerged since the initial development of the measurement framework. In October 2019, the envlronmerit.al scan was published and yielded no updates to the Diagnostic Process and Outcomes domain, but the scan did identify several articles supporting the composition of the subdomains, and their continued relevance to reducing error. There were also no updates made to the domain of High-Priority Areas for Future Measure Development. The scan did identify 19 new fulfy developed measures to add to the measure inventory, as well as 17 new measure concepts applicable to the process and outcomes domain of the framework. The measures were primarily concerned with the Diagnostic Efficiency and Diagnostic Accuracy subdomains of the Diagnostic Process and Outcomes domain; otner measures were identified in the Information Gathering and Documentation subdomain. Building on the environmental scan, the work of the Committee wilt continue In 2020 wfth development of practical guidance in the application ofthe Diagnostic Process and Outcomes component of the original framework, including identifying founpeci:fic use cases to demonstrate how the framework can be operationalized in practice. The final report will include recommendations for the application of the conceptual framework to reduce diagnostic errors and improve safety in a variety of systems and settings, with appllcaoonstomultip!e populations. Maternal Morbidity and Mortality Maternal morbidity and mortality have been identified as primary indicators for women's health and quality of health globally. Maternal morbidity refers to unexpected short· or long-term outcomes that result from pregnancy or childbirth. These outcomes-can include blood transfusions, hysterectomy, respiratory problems, mental health conditions, or other health conditions thatrequlre additional medical care, such as hospitalization and long-term rehabilitation, and that can affect a woman's.quality of life. 67 Maternal mortality, whkh includes deaths that occur up to one year after the pregnancy ends, may be caused by a pregnancy complication; a chain of medical events star:ted by the pregnancy; the worsening of an unrelated condition because of the pregnancy, delivery type or obstetrical complications; or other factors. 67 The Healthy People 2020• target goal for U.S. maternal mortality is 11.4 maternal deaths(per 100,000 live births) with a current U.S. rate of 17.2 maternal deaths.(perl00,000 live births). 611 The U.S. is the only industrialized nation with a rising maternal mortality rate, with more than 700 women dying annually from pregnancy-related causes. These rates vary by region, state, and across l'acial and ethnic lines, where significant disparities highlight exacerbating differences among non-Hispanic black women (42.8 percent)and American Indian/Alaska Native (32.5 percent) women. leading causes:of maternal mortality are attributed to increased rates of cardiovascular disease, hemorrhage, and infection. 69 e I CDC. Pregnancy-Related ~ths. relatedmortality.htm. Published February 26, 2019. Last accessed .ianuary 2020 VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00092 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.047</GPH> 39 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60217 Recent studies indicate that severe maternal morbidity affects more than 60,000 women annually in the U.S., with nsing trends over the last two decades. 67'"m Severe morbidity poses a tremendous risk to .the health and well•beingof women, and although the causes of the. rising rates are undear, It is evident thatracial disparities are pervasive. Therefore, it is vital to understand the causes ofboth maternal morbidity and mortality to improve maternal health outcc,mes for all populations. ln fall 2019, NQf began a two-year project to assess the current state of maternal morbidity and mortality measurement and to provide recommendations for short· and long-term approaches to improve this measurementand apply it to improve maternal health outcomes. This assessment will result in twosepatate measurement frameworks-one fur maternal morbidity and one for maternal mortality, To achieve this, NQF recruited a 30-person multistakeholder committee to guide and provide input on the environmental scan, frameworks, and measure concepts of maternal morbidity and mortality. NQf began work on an environmental scan to review, analyze, and synthesize information related to maternal morbidity and mortality. The project work will continue in 2020 with the finalization of the environmental scan, and develc,pmentoftwo frameworks and measure concepts. VIII. Conclusion Over the past 20 years, NQF's continuous efforts to improve health and healthcare through measurement have been closely linked with the national priorities of making care safer, strengthening person and family engagement, promoting effective communication, promoting effective prevention and treatment of thronic disease, working with communities to promote best practices of healthy living, and making care .affordable in partnership with public and private healthcare stakeholders across the country. This year, NQf sought to promote coordination across public and private payers. The increased reliance on performance measures has led to expansion in the number of measures being used and an increase in burden on providers collecting the data, confusion among consumers and purchasers seeing conflicting measure results, and c,perational difficulties among payers. The Core Quality Measures Collaborative {CQMC), a broad-based coalition of healthcare leaders, was constituted to promote the use ofa core set of measures while minimizing the burden on clinicians and providers. This collaborative aims to suppc,rt the collection of better information about what happens after a measure is implemented. This will ensure that NQf-endorsed measures are driving meaningful improvements and not causing negative unintended consequences. Public and private payers continue to look to VBP and APMs as methods to reduce the growth of healthcare costs and to incentMze high quality care. However, such payment models require evidencebased arid scientifically sound performance measures to assess the value of care provided rather than the volume of services rendered. Moreover, these measures must be implemented in a way that minimizes provider burden while advancing national healthcare improvement priorities. NQF' s work in evolving the science of performance measurement has also expanded over the years, and recent projects, such as CQMC, whim focuses on identifying the right quality measures for use across payers, align with the NQS' emphasis on public-private collaboration. The Opioid Expert Panel addressed the challenges in OUD quality measurement NQF continued to bring together experts through multistakeholder committees to identify high value, meaningful, and evidence-based performance measures. NQF's work to review and endorse VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.048</GPH> 40 60218 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices performance measures provides stakeholders with valuable information to improve care delivery and transform the healthcare system. NQF-endorsed measures enable clinicians, hospitals, and other providers to understand if they are providing high quality care and determine where improvement efforts may need to be focused. NQF maintains a portfolio of evidence-based measures that address a wide range of clinical and cross-cutting topic areas. In 2019, NQF endorsed 110 measures and removed endorsement for 41 measures across 28 endorsement projects addressing 14 topic areas. NQF remains committed to ensuring the endorsement process is innovative and efficient with a seven-month review cycle twice every year and extended public commenting periods for greater transparency. MAP convenes organizations across the private and public sectors to recommend measures for use in federal programs and provide strategic guidance on future directions for these programs. MAP comprises stakeholders from across the healthcare system including patients, clinicians, providers, purchasers, and payers. Through its nine years of pre-rulemaking reviews, MAP has aimed to lower costs while improving quality, promoting the use of meaningful measures, reducing the burden of measurement by promoting alignment and avoiding unnecessary data collection, and empowering patients to become active consumers by ensuring they have the information necessary to support their healthcare decisions. MAP's work that concluded in 2019 included a review of unique performance measures under consideration for use in 18 HHS quality reporting and value-based payment programs covering clinician, hospital, and post·acute/long·term care settings. Additionally, MAP began new work in November 2019 to provide input on 19 measures under consideration for 10 HHS programs, During their 2019 deliberations, many NQF standing committees discussed measure portfolios and identified measure gaps, where cross-cutting or high value measures a re too few or may not yet exist to drive improvement. NQF's standing committees surfaced important measurement gaps in areas such as behavioral health, substance use, and perinatal and women's health, MAP also identified measure gaps to assess care and improvement in federal healthcare programs. In 2020, NQF looks forward to addressing additional issues and collective efforts to address measurement science challenges and furthering the portfolio of high value measures that public and private payers, providers, and patients rely on to improve health and healthcare. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.049</GPH> 41 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices IX. 60219 References 1 Thronghout this report, the relevant statutory language appears in italicized tei..1. 2 Contract ·with a Consensus-Based Ent-ity Regarding Performance Merumrement. 42 U.S;C. 1395aaa(b)(l) (2014). 3 ScboH L, Seth P, Kariisa M, etal Drug and opioid-involved overdose deaths-· Utiited States, 2013-2011.MMWRMorbAfortal WklyRep. 2018;67(5152):1419-1427. 4 Saloner B, Barry CL. Ending the opioid epidemic requires a historic investment in medication-assisted treatment. 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Last accessed February 2020. 43 Committee on Military Trauma Care's Leaming Health System and Its Translation to the Civilian Sector, Board on Health Sciences Policy, Board 011 the Health of Select Populations, et al. A lVational Trauma Care System: Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury. (Berwick D, Downey A, Cornett E, eds.). Washington (DC): National Academies Press (US); 2016. ·JI · · l 9 ·. Last accessed January 2020. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00097 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.052</GPH> 44 60222 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 44 Centers for Disease Control and Prevention (CDC). Emergency Department Visits. https:J/wwvv.cdc;gov/ncl1Slfastats/emergency~department.htm. Published September 4, 2019. Last accessed January 2020. 45 Florence C, Sim011 T, Haegerich T, et al. Estimated lifetime medical and work-loss costs of fatal mjnries-United States, 2013. AlAIWR Moro Mortal Wkly Rep. 2015;64(38):1074-1077. 46 Centers for Medicare & Medicaid Services (CMS}, HHS. Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. Final rule. FedRegist. 2016;81( 180):63859-64044. 47 The Joint Commission.Emergency Management in Health Care. Tiurd edition. Oak Brook, IHmois; 2016. 48 Thompson DA, Eitel D, Fernandes CMB, et at Coded chief c-0mplaints-automated analysis of free-text complaints, AcadEmergl,/led. 2006; 13(7):774-782. 49 Johnson R Toohey D, Wiener J. Meetii1g the long-tenn care needs ofthe baby boomers: how changing families Will affect paid helpers and institutions. January 2007. 50 Basch E. New fro11tiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment. Annu Rev Med. 2014;65:307-317, 51 Cella D~ Hahn E1-\,. Jensen SE, et al. Patient-reported outcomes in perfonnance mea._'\Ufement Research Tria11gle Park (NC): RTI Press; 2015. . Last accessed January 2020; 52 Lavallee DC, Chenok KE, Love RM, et al. Incorporating patient-reported outcomes into healtb care to engage patients and enhance care. HealthAjf(l1lillwood). 2016;35(4):575-582. 53 Greenhalgh J, Dalkin S, Gooding K, et al.Functionality and feedback: a realist synthesis of the collation, interpretation and utilisation ofpatient-reported outcome measures data to improve patient care. Soulhampton (UK): NIHR Journals Library; 2017. http:Jlwww.ncbi.n1m.nih.govlbookstNBK409450/. Last acces..~d January 2020. 54 Snyder C, Brundage M, Rivera YM, et at A PRO-cision medicine methods toolkit to address the challenges of personalizing cancer care using patient-reported ouu."'Omes: introductioo to the supplement. Med Care. .2019;57 Suppl 5 Suppl i:Sl-S7. 55 van Egdom LSE, Oemrawsingh A, Venvejj LM, et al. Implementing patient-reported outcome measures in clinical breast cancer care: A systematic review. Value Health. 2019;22( 10): 1197-1226. 56 Basch E, Deal AM:, Kris MG, et al Sympfmn monitoring with patient0reported outc9mes during routine cancer treatment: a randomized controlled trial. J Clin Oncol; 2016;34(6):557565. 57 Baumhauer JF. Patient-reported outcomes - are they living up to thek potential? N Engl J }vied. 2017;377(1):6-9. 58 Health IT. Health IT Quick Stats. Last accessed January 2020. 59 Institute of Medicine (US) Committee on Data Standards for Patient Safety, Tang P: Key Capabilities oftmElectronic HealthRecord System: Letter Report. Washington (DC): National Academies Press (US); 2003. https://wV1,'w.ncbi.n1m.nih.gov/bookslNBK22l802/. Last accessed January 2020. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00098 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.053</GPH> 45 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60223 60 Eisen~g F, L<l$ome. C, Advani A. et al. A study of tbe impact of~eaningful use .clfl.l;ical qualitym~s, AmertcanH<FSpital Assoctatr¢1,2013i 6] ·Bailey LC. Mistfy'.l{S,tfoocoA, et al. Addressing efofflonic ~linic!d informatibn irilhe. construction ot'qua:titym~, Acad Pedtatr.1014;14(5 Suppl):882-89. 62 Bush ~ 1'u.elbsQ~J{yµJ:, ~tat. $tructureddata:entryi.ritli~:~Je~rticmedical ~ Perspectives ofpediatric sp~alty physicims and smgeoos, JM(«[Systi 20 l 7;41(5):'75. 63 Abern~thy ~. ®p~j. P~lkat R, et at. tJse ptelectrQtticli~ recotd data f'or(luallfy: reporting,.!: 0:ncoffract. 2017;13(8): 530~534; · 64 Singh H, Meyer A.~, Thomas EJ. The frequencyofdiagnostic errors in outpatientcare: estimations from three large observational studies involving US adult populations; RMJ Qual 2014;23(9):777-73 L 65 NationalA.cademies ofScieri~. E. JmprovingDidgnoiisfnHealthCare; 2015. hUps;Jl:w#;n@~edulmt2Ut1211241imru·o•~..m4wa1th:m. Last acctssedJanuary 2020, · 66 Natio11alQtililityFotUnL.[111F~ Diagnos#c~litytl1Jif.$dfet)t, 2017.. Wtps ;tlwww-,mibfQJUDL~licatio11§12Qlji09Qmprov~st,ic ety_ final R@ttC: Last.accessed Octobet2()l9; ~ d $4 67 CDC, Sever¢ ~atern!i}M~idity in the Unitoiid$tates. _ ··... https:/lwyfw~cdc:.govli~tiveheal1ltf111atemalirifamhealth/severematen1aimorbidiJ:l:.htmL Published Jannacy 17, 2019: Last accessed January 2020. · (18: CDC. Pregnan.cy-Relatedl>eaths. https://WWX'f,cdc;gov/reptoductivehealth/matemalinfagthealth/prepcy• [Slatgdmort!lity,llbn. Pu1:>lished J<'ebruary 26~ 20l?, l,8$t accesse:d January 2020, 69 COO. ReptiXJuctive Health. h:itps;Jiwww,cdc.gs,vti@mductivehealihlindex.htrnl. Publishiu( December6~ 2019, Last~Januacy 2Q2Q, 70 HowellEA. Reducing,Disparities n1 Severe Maternal Morbidity and Mortality. Clin Obstet Gynecol. 2018;61(2):387a399. 7i Callagbatl WM. Cr:~~ AA. Kuklina EV. S\,yf.ltem:ateµial morbidity among defiv~ aml postpartum h<>spitaliza:tions in the Un.ited states; Obstet Qy,lecol. 2012;120(5):1029~1036. VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00099 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.054</GPH> 46 60224 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Appendix A: 2019 Activities Performed Under Contract with HHS 1. Federally Funded Contracts Awarded in FY 2019 HHSM-500-2017-000601 7 5FCMC1Sf0001 HHSM-500-2017-000601 75FCMC18!'0009 HHSM-500-2017-000601 75FCMC18F0010 HHSM-500-2017-00060I HHSM-500T0001 HHSM-500-2017-00060! HHSM-500T0002 Social Risk Trial - This three-year project explores the impact of social risk factors on the results of measures and the appropriateness of including social risk factors In the riskadjustment models of measures submitted for endorsement review. Core Quality Measures Collaborative (CQMC)- The CQMC is a multlstakeholder collaborative with representation from various specialty organizations across the healthcare landscape working together to recommend core sets of measures by clinical area to assess the quality of American health care. The 110luntarv collaborative aims to add focus to quality improvement efforts, reduce the reporting burden for providers, and offer consumers actionable information to help them make decisions about where to receive their care. Common Formats-A project supported by AHRQ to obtain comments from stakeholders about the Common Formats authorized by the Patient Safety and Quality Improvement Act of 2005. "Common Formats" refers to the common definitions and reporting formats that allow collection and submission of standardized information regarding patient safety concerns. Endorsement and Maintenance - NQF recommends the best-in-class quality measures for use in federal and private improvement programs. Measures can be submitted for endorsement twice a year in 14 topic areas including behavioral health and substance use, patient experience and function, and all-cause admissions and readmissions. Annual Report to Congress-An annual report that summarizes projects funded under the contract with the Department of Health and Human and Services. May15,2019-May14, 2020 (Option Year 1) September 14, 2019September 13, 2020 (Option Year 1) $275,884 September 14, 2019September 13, 2020 $128,340 September 27, 2019September 26, 2020 $9,679,359 (Option Year 2) September2:7, 2019September 26, 2020 $123,821 (Option Year 2) VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00100 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.055</GPH> 47 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60225 .!MAel, MAP reviews meu11 res that HHSM-500.201Nl00601 7SFCMC19F0001 Hl:iSM-500.2017-000601 7SFCMC19F0002 HHSM-500-2017-000601 7SFCMC19F0003 CMS Is considering Implementing and provides 11uldllnce on their acC!!lptabllity and value to stakeholders, MAP makes these recommendations through its prerulema!dn& process that enable$ a mult15talieholder dialogue to assess measurement priorities for these r rams, Person-Centered Plannln& and Pradlce (PCP)-PCPplays a key role .ln the provision of long-term serllices and supports. This project is estabUshing ii foundation tor performance measurement In person-centered planning, Identifying measure gaps, and developing aframewo·rkto analy!e and p~ioritlze gal)il for future measure de~lopmc1nt. Opioid Technical Expert Panel (TEP)NQF convened a multistakeholder TEP pursuant to the 2018 SubstlMC!!l UM• Disorder Prevention that Promotes Qploid llecovery and Trntmentfor Patients and communities (SUPPORT) Act. TheTEP's charge was to review quality measures that relate to oploids and opioid use disorders, Identify gaps In aren that relate to oplolds and opioid use dlsorde~ and priorities for measure development for such gaps, and make recommendations to HHS on quality measures with respect to. oplolds and opioid use disorders for pu·rposes of Improving care, preventiim, diagnosis, health outcomes, and treatment. Patient Reported Outcomes (PRO)NQF convened a multistakeholder TEP to Identify best practlces to address challenges In selecting and collecting PRO data, make recommendations for use of best practicesto address challenges In PRO selection and data collection, and ensure data quality, and apply the recommended best practices on selection and impleml!ntation to use cases related to burns/trauma, heart failure, and ·oint re aC!!lment. (Option Year 1) February&, 2019August 2, 2020 $774,998 February 7, 2019 February&, 2020 $542,555 June 10, 2019-June 9, 2020 $502,288 VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00101 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.056</GPH> 48 60226 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices HHSM•500'-2017-000601 HHSM-500-2017-000601 HHSM•S00-2017-000601 HHSM-500'-2017-000601 75fCMCl9F0004 Electronic Health Recore! (EHR) Dita Quality Best Practices for Increased Scientific Acceptabi11tv-Eled:ron1c clinical quality mi,asures (eCQMsl a111 designed to 11nable automated reporting of measures using EHR data. This 18-month project identifies. the causes, n~ure, ~nd extent of EHR data qus1l1ty !$$lies related to eCQMs, the Impact that poor EHR data quality has on scientific acceptabilltv, use and usability, and feasibil1tv; and make recommendattons for best practices In usesslng and Improving EHR data quality to improve the relfabllity and validltY, use and usability, and filaslblllty of eCQMs. 75FCMC19FOOOS Reducing Oiagnost le Error - - Th Is. project builds on the Diagnostic Quality and Safety Measurement Framework published In 2017. A multlstakllholder expert committee Identified any hlgh-prlorlty measures, measure ~oncepts, current performance measures, and areas for futuril measu111 development that ha\ltl emerged since the lnlt111l development of the measurement framework. The next phase will Include reCC1mmendatlons on how the framework can be operationalized lri rac:tlee. 75FCMC19F0007 Rural Health Technical Expert Panel (TEP)-The TEP NI viewed previousiy. identified approaches to the low-casevolume challenge and provided feedback and recommendations to address the low-case•110lum11 challenge that many rural providers face. 75fCMC19F0008 Maternal Mor.bidity and MortalityThis two-vearproject will assess the current state of maternal morbidity and mortality quality measurement and pro\lide recommendations for short• and long-term approaches to improve this measurement and apply ltto improve maternal health outcomes. July 1, 2019-De<:ember $554,421 :u,2020 July 15, 2019-0ctober $524,854 14, :i.020 September 6, 2019 September 5, 2020 $398,016 September 18, 2019September 14, 2021 $781,321 I $12,091,362 TOTALAWARD 1 VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00102 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.057</GPH> 49 60227 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 2. NQP financial Information for FY 2019 (11naudited) Contributions and Grants Investment Income Other Revenue $23,594,966 $656,873 $374,604 $213,411 TOTAi. REVENUE $24,839,854 Program Service Revenue -- Grants and Similar Amounts Paid. Benefits Paid to or for Members Salaries, Other Compensation, Employee Benefits Other Expensesf 11,981,017 $7,614,615 TOTAL EXPENSES VerDate Sep<11>2014 N~he.r Expensesu may im;ll.ll;le ope,:atlngand oyerhead g>S1:S. 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00103 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.058</GPH> f $19,595,632 60228 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Appendix B: Multistakeholder Group Rosters: Committee, Workgroups, Task Forces, and Advisory Panels As a consensus-based NQF ensures there is comprehensive representation from the healthcare sector across all its convened committees, workgroups, task forces, and advisory panels. Consensus Development Process Standing Committees All-Cause Admissions and Readmissions Standing Committee MRP Public Polley Institute Office of Nursing Services. Veteran's Washington University School of Medicine; Washington University Brown Health Administration North CO-CHAIRS School of Social Work John Bulger, DO, MIIA Paulette Nlewtzyk, PhD, MPH Uniform D;,ta System for Medical Geisinger Health Lisa Jensen, DNP, A.PRIil Karen Joynt Maddox, MO, MPH D Kelleher Consulting Kraig Knudsen, PhD Ohio Department of Mental Health and Rehabilitation Cristie Travis, MSHHA Memphis Business Group on Health Addietion Services Carol Raphael, MPA Michael R. l.llrdlerl, lCSW Manatt Health Solutions MEMBERS Dolores (Dodi) K"lle-her, MS, OMH Nm1hwell Health, Behavioral Health Mathew Reidhead, MA Services line Katherine Auger, MD, MSc Missouri Hospital Association; Hospital Cincinnati Children's Hospital Medical Industry Data Institute Tami Mark, PhD, MBA Center RTI tnternationa I Frank !lrlggs, PharmD, MPH Pamela Roberts, PhD, MSHA, ORT/I., SCFES, FAOTA, CPHQ, FNAP, FACRM West Virginia University Ilea lthcare Cedars-Sinai Medical Center Jo Ann Brooks, PhD, RN Indiana University Health System MIA The Nicholson foundation !.lemadette Melnyk, PhD, RN, CPNP/FMNP, FNAP, FAAN Derek Robinson, MO, MBA, FACEP, CNCQM The Ohio State University Health Care Service Corporation Mae Centeno, DNP, RN, CCRN, CCNS, ACNS-!IC Thomas Smith, MO, FAPA Baylor Health Care Sy<t<em Columbia University Medical Center Helen Chen, MD Hebrew Seniorlife Raquel Mazon J"ffers, MPH l.aurence Miller, MO University of Arka nSlls for Medical Sciences !lrooke Parish, MD Blue Cross Blue Shield of New Mexico Behavioral Health and Substance Use Standing Committee Susan Craft, RN Henry Ford Health System William Wesley Fields, MD, FACEI' UC Irvine Medical Center; CEP America St.,ven Fishbane, MD North Shore-Lil Health System for Network Dialysis Services Paula Minton Foltz, RN, MSN Patient Care Services l.aurent Glance, MD University of Rochester School of Medicine; RAND Anthony Grigonis, PhD David Paling, MD Kaiser Permanente: 'San Francisco Vanita !>lndolia, l'harmD, M!IA CO-CHAIRS Henry Ford Health System Peter Briss, MD, MPH Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Hea kh Promotion Andrew Sperllng,JD National Alliance on Mental Illness Harold Pincus, MD J"ffery Sum1an, MD NewVork~l'rnsbvterian Hospital, The University Hospital of Columbia and Northeast Ohio Medical University Michael Trangle, MD Camell HeaithPartners Medical Group Select Medical MEMBERS Bruce Hall, MO, PhD, MBA Mady Chalk, PhD, MSW Washington University in Saint Louis; BJC The Chalk Group Bonnie Zima, MD, MPH University of California, Los Angeles (UCLA) semel Institute for Neuroscience and Human Behavior David Einzig, MO Healthcare Leslie Kelly Hall Healthwise Paul Heidenreich, MD, MS, FACC, FAIIA Stanford University School of Medicine; VA Palo Alto Health Care System Children"s Hospital And Clinics Of I.Mlle S. :Zun, MD, MBA Minnesota Sinai flealth System .lulle Goldstein Grumet, PhD Education Development CMter/Suicide Prevention Resource Center/National Action Alliance for Suicide Prevention Sherrie Kaplan, PhD UC Irvine School of Medicine Keith llnd, JD, MS, !!SN Lisa Sh<ea, MO, DFAPA lifespan Cancer Standing Committee CO-CHAIRS Cor1s1anc" Horgan, ScD Karen Fields, MO The Heller School for Social Policy and Moffitt Cancer Center Management, Brandeis University VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00104 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.059</GPH> 51 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Shelley fuld Nasso, MPP,CEQ National Coalition for Cancer Survivorship Thomas Kottke, MD, MSPH .Cost and Efficiency Standing Consulting Cardiologist,.HealthPartners Committee MEMBERS CO-CHAIRS MEMBERS Carol Allred, 8A Grqary liocsl, DO, FCAP UnlversltV of Colorado lla,~pltai Clinical· Women Heart: The Nationa I Coalition for Women with Heart Oise,ue Bren! Asplin, MD, MPH Independent Labora.tory llnda Baas, PhD, RN Brent 8raveman, Ph.D, 01'11/1.;. FAOTA Cheryl Dambelll, PhD RAND DiStlngulshed Chair In Healthcare University of Cincinnati Payment l'olir.y University of Texas M.D. Anderson c~ncer Center Steven.Chen, MD, MBA, tACS OaslsMD Unda ilrins, DNP George Washington University, School Qf Nursing. Leslie Cho, MD Retired Joseph Cleveland, MO University of Coloradil Denver Heidi ,1oyd Patleht Advocate MEMBERS ICri$tlne Manin Andetsort, MBA lloor Allen Hamilton Lawrence Becker Cleveland Clinic Matthew Facktor, MD, 'ACS Gelslnt111r Medical Center Mal"y Ann Clarti, MHA Avalere SIGNALPATH Mlthael Crouch, MD, MSPH, FAA.Fl' Texas A&M University School Qf Medicine. Troy· Fll!Slnger, MD, FAAFP Vlllage Family Practlee Jette Hccenmlller, PhD, MN, APRN/ARNP, CD£, NTP, TNCC, ar tltubeth Del.one, PhD Duke UnivtrsltY Medical Center Nancy Garrett, PhD Hennepin County Medic.al center llradford Hinch, MD oncolcsY Nurse Practitioner Kumar Dharmarajan, MD, MllA Andrea Gelzer, MD, MS, FACP I ..l.eonard. Uchtenfelcl, MD, MACP Clover Health Amerlflealth Carltas American Caneer Society WIiiiam Downey, MD Stephen Lovell, MS Carolinas HealthCare System. hchae,I Howci, MS, l!SN, RN i!M HIS Suttle Canc:,irCare Alliance Patient and Advisory Council Jennifer Eames Huff, MPH, CP£H JEH H~alth Consulting; Pacific Business Group on Health Brian Fonrest, MD Healthcare Oil'ect Al:CHS lenrtlflll' Malin, MD, PhD Anthem, Inc. Naftll11 ZIii Fr11nkel, MS Sunny Jhamnalll,MD D~clore Consulting .Ellen Hillegas11, PT, EdD, CCS, FAAC\IPR, FA.PTA American Physical Therapy Association Va le UnlversltV 8enJamln Movsas, MD Thomas James, MD Baptist Health Plan and 8aptist Health Jason Lott, MD, MHS, MSHP, FAAD !layer US LLC Henry Ford H•alth Syst~m Comm unity Care Manin Man:lnlak, MPP, PhD Diane Otte, RN, MS, OCN Mayo Clinic Hea~h System - Franciscan Healthcare Charles Mahan, PllarmD, PhC, l!Ph GlaxoSmithKline Presbyterian Healthcare Servl~s and Univei\lity Qf New Mexico James Naessens, SeD, MPH Mayo Clinic Beverly Rilglt, PhD, RN Joel Milm, PharmD, FCCP, FAS HP, FNI.A, !ICPS•AQ. Cardiology, 8CACP, CLS .lack Needleman, Ph'D Jodi Maranmle, MD, FA.CS University of Pittsburgh All McBride, PharmD, MS, l!CPS The Unl\lersity <lfArliona Canter Center University of Cincinnati College of Nursing Roblll't Rosenb11rt1, MD, FA.CR R~dlology A$.mciates of Albu~ uerque University Qf ColoradoAnschutt Medie,,I Camiws David J, Sher, MD, MPH KristiMl1d1ell, MPH Avalere Health, Llc· UT Southwestern Medical Center Gary Puckreln, PhD' FSCAI, UVM, FCPP Cardiovascular Standing Watson Health, IBM UCLA Fielding Schoel Qf Pubilc Heak b Janis Orlowski, MD; MACP Association of American Meclital Colleges Minnesota Health Actto·n Group Nicholas lt\lgglero, MD, MCP, FACC, · Usa l.lltts, MD, MSPH, MBA, FACP CarolynPn NationalMinorltyQ.uallty Forum Danielle: Ziernicki, Ph:annO Dedhatl'I Group 60229 Thomas Jefferson University Hospital Committee Jason Spangler, MO, MPH, FACPM C0°CHAJRS Susan Stron• Mary George, MD, MSPH, FA.CS, FAHA Heart Value Voice Coiorado Centers for Dlstase c0mrol 1nci l'l'!!'!entlon (CDC) Mladen Vidovich, MD Amgen, Inc. John Ratliff, MO, FA.CS, FAANS Stanford Uniwrs.tty Medical Center· Srinlvlis Srldhara, PhD, MHS The Advisory Board company Una Walker, PhD AAIIP Publ!c Polity Institute 8111Welntnub, MD, FAIX Med Star Washington Hos pita! Center Htrben Wong, PhD University of Illinois at Chl(ago, Jesse Brown VA Medical Center Agency for Htalthcare Research and Quality VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00105 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.060</GPH> 52 60230 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Dolores Yanagihara, MPH Integrated liealthcam Association l>ouglas·Nee, PharmD, MS Clinical Pharmacist, Self•Empfoyed Valerie Cotter, DrNP, AGPCNP•BC, FAANP laura Porter, MD John Hopkins School of Nul\llng Orthopedk: surgery Technical Colon Cancer Alliance llradford Dickerson, MD, MMSC EKpert Panel Cindi Pul'sll!'f, RN, CHPN VIIIA Colorado Hospice a nd'Palliatlve-C_are Mas~ai;husetts General Hospital Tlnu11hy Henlill1 MD Orthopedic Associates of Michigan 1>ora1hy tdwards, Phi> University of Wisconsin Madison School of Medicine and Public Health Lynn Reinke, Phi>, ARNP, FAAN VA Puget Sound Health c-re System llrya11 Little, MD Detroit Medical center, Detroit Medical ,Amy Sanders, MD, MS; FAAN Center SUNY Upstate Medical University Anthony Mascioli, MD UnlVerslty of Tennesseweampbell Clinic Tracy Schroepfer, PhD, MSW Unlllerslty of Wisconsin, Madison, School of Soc/al Work Kimberly Templeton, MD Reuven Fenlger, MD Merck and Company Charlotte JOne$, MD, Phi>, MSl>H Food and Drug Administration Michael Kapffl1, MD,. Phi> Welti Cor~ell Medical College University of Kansas Medi<:alCenter Linda Schwimmer, JI> New)ersev Health CareO.uallty lririltute Melody Ryan, Pharml>, MPH Geriatrics and Palliative Care Standing Committee ChrlstlneSeel lillchle, MD, I\IISPH Unl\lerslty of Callfornla San Francisco,. Jewish Home ol San Francisco Center for Resea rth on Aging Urtlverslty of Kl!ntucky College of CO-CHAIRS R. Sean Morrison, MD Pattv arid Jay Baker National Pallliitlve Care Center; National P'alliatlve Care ~esearch Center; Hertzberg PalllatlVe Cari: lnstilute, Icahn School of Medicine at Mount Sinai Deborah Waldrop, PhD, LMi.W1 ACSW University of Buffalo, School of Social Work MEMBERS Ma111e Atkinson, l>MU1, ace Morton Plant Mease/Bay Care Health Svt,tem Semlni kckwllh, 1.CSW, FACHE, LHI> Hope Heatl:hca re Services Amy J, Berman, Rill, lHD, FAAN lohn A. Hantord Foundation Eduardo flruera, MD University of Te~as· MO Anderson Cancer Center Cleiinne Can, 1)0, FAAHl'M, FAAFI' Hospice of Dayton Geo11e Handzo, ace, CSSBII fle.ilthCare Chaplaincy Roben Sldlow, MD, MBA, FACI> Memorial Sl011n Kettering Cancer Center Duke ·Cancer Institute Ross Zafonte, DO Harvard Medlcal'School of V!sta, Carlsbad by the Sea care Center, llospll:11 by the Sea Patient Experience and Function Standing Committee l'aul E. Tatum, MD, MSPM, CM!>,. FAAHl'M, AGSF Dell Seton Medical Center at Uii hierslty of Texas, Austin Grw Vandtal<left, Ml>, MA Providence Hea~h and Services Donald Casey, Ml>, MPH, MBA, FACP, FAHA, l>FACMQ Presldent,Elect., American Collet~ of Medical Quality (ACMQJ Neurology Standing committee Gerri Lamb, Phi>, RN, FAAI\I Associate Profeuor, Arizona State University David Knowlton, MA Retired Lee Panrldge Advisor, United llosptl:al Fund David Tlrschwell, MD, MSc Christopher Stille, Ml>, MPH, FAAP Profeuor of Pediatrics, University of Colorado School of Medicine; Section He~d, Section of General Academic Pediatric, Unl~ersltv of Colorado School of Medicine & Children's Hospila I Unl\lerslty of Washington, Harborvlew MedlcalCent11r MEMBERS iocelyn llautlsta, MD Cleveland Clinic Neurological Institute Epilepsy Center Ketan Bulsara, MD Yale Oepartmentof Neurosurgery Kelly Michaelson:, Ml>, MPH, FCCM, FAP James au!lle, MD Northwestern University Felti berg School of Medicine; Ann and Robert H. Lurle Children'.s Hosplt,al of Chicago UnM!rslty of Michigan Alvln Moss, MD, FACP, FAAHPM Center of West Virginia University CO.CHAIRS CO-CHAIRS Anthem BhJe Crosnnd Blue Shield Katherine Uchtellberl, DO, MPH, FMFP KelfV SUOlvan, Phi> Georgia Southem Unlversltv · Karl Stelnbe!I, MD, CMD, HMDC Georgia Regents Medical Center FAAHl>M Northwestern UnlVerslty Mariner Health Central, life Care Center Ooid Andrews Arif H. llamal, MD, MBA, MHS, FACP, Pharmacy .Ja~e Sufflvan, PT, l>HS, MS MEMBERS Ryan Coller, Ml>, MPH OIVlslon Chief, Pediatric Hospital Med lcine, University of Wisconsin• Madison Sharon Cross, LISW•S Program Director, Th<! Ohio State University Wexner Medical Cente.r Mldleffe Camkla, MSN, RN, PHIi!, CRRN, CCM,FAHA Kaiser Foundation Rehabilitation Center Christopher Dezll, MIIA, RN, CPHQ Director, flealthcareO,ualltv & Performance Measures, llrlsto~-Myers Squibb Company VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.061</GPH> 53 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Sharl Elickson, MPH Director, Healthcare Quality & Perlorma nee Measures, Bristol-Myers Squibb Company Tracy Wang, MPH MEMBERS Jason Adelman, MD, MS Director of customer Service, Johns Hopkins Home Care Group Chief Patient Sl!fetv Officer, Associate Chief Qua llty Officer, and Director of Patient Safl!ty Research at New Yorlc-· Presbyterian HcspltaVColumbla University Medical Cl!nter Stephen Hoy Chief Operating Officer, Patient Family Centered Care Part.ners Charlotte Ale11ander, MO Ortho1>ed1c Hand Surgeon. Memorial Hermann Medical System Sherrie Kaplan, PhD, MPH Professor of Medicine, Assistant Vk:e Chancellor, Healthcare Measurement and Evaluation, Urilverslty of California Irvine School of Medlcl\'le laura Ardizzone, ·BSN, MS, DNt>, CRNA DaWII Hohl, RN; BSN, MS, PhD Brenda teath, MHSA, PMP · Senior Olrec:tor, Westat R1.1ssell LI!ltwlch State of Tennessee, Office of eHealth Initiatives Brian Undberg, 8$W., MMHS EKetl.ltlve Director, Consumer Coalition for Quality Neah:h Care Usli Morrlse, MA PatlentCe>•Chalr, Patient & Family Engaeement Affinity Group National Partnership for Patients. Charissa Pacella, MD Chief of Emergency Servfees and Medical Staff, University of Pittsburgh Medical Cent\lr fUPMC) Director of Nurse Anesthl!:,la Services, Memotial sioan Kettering CancerC,mter Richllfd Briffl, MD, FAAP, FCCM John F. Wolf!! Endowed Chair In Medk:al leadership and Pediatric Quality and Safl!tv Chlllf Medical Officer· Nationwide Children's HC>Spital Professor, Pediatrics• Pediatric Crh:lcal.Ca re Medicine • Ohio State University College of Medicine Curtis Collins, Phllm, D, MS Speciatl.y Pharmacist, Infectious Diseases, St, Joseph Mercy Health System Development, bloMerleux thllffla Edelstein, Ml>H,. lNHA Vice President, New Jersey Hospital and P.erlorman·c11 lmprow·ment, Metropolitan Jewish Health System S,enlor Fellow and Nurse E~ecutive, Safetcare TeMat, University of North Texas Nealth Science Canter Debra Saliba, MD, MPH Kendall Webb, MD, FAttP Chief Medkal lnform~tlon Officer, University of Florida Hta~h Systems; Associate Professor .of tmergency Med !cine and Pediatric EM; Assistant Dean of Medi<:al lnformatks University of Florida Health•· Jacksonville Albert Wu, MD, MPH, FACI' Professor of Health Policy and ManagemMtand Medicine, Johns Hopkins University De11ald Yealy, MO, FACEP Professor and Chair, University of Pittsburuh•Oepartment of Emergency Medkine YilllllngVu, Phi) Physkal Oceanographer and Patient Safety Advocate, Washing.ton Advocate for Patient Safety CO-CHAIRS Melissa Danforth, 8A Sti!nlor Director of Hospital Ratings, The Leapfrog Group Association Public llta~h Program Director, WellPoint, Inc, Perinatal and Women's Health Standing Committee ChlistopherCooll, PharmD, l'IID Sr. Director, Sttategk: Buslnes~ l.enard Palisi, RN, MA, CPHQ, FNAHQ Vlce President of Quality Management Kimberly Gregory, MD; MPH Vite. Chair Women's Healthcare Quality & P~rformante lmprov~ment; llePt Ob/Gyn, Cedars-Sinai Medlr.al c:iinter Carol Sakala., PhD, MSPH Director of Childbirth connection Programs, National Partnership for Women & Fam/lies u•ee Gehnas, MSN, RN, CPPS, l'AAN MEMBEllS Profeuor of Medicint!, UCLA/JH Borun Center, VA GR£CC, RAND Health John James, Pho· 1111 Arnold F,ounder, Patient Safety· America Ellen Scllulu, MS Senior Researcher, Am.erkan Institutes Stephen Lawless, MD, MBA, FAAP, FCCM Se.nlorVite President.Chief Clinical Ellecutille Dll"llctor, Maternal Safety Foundation J. Matthew Austill, PhD for Research Officer, Nemours Children's.He.11th System Jennifer Balllt, MD, MPH PeterThomas,io Faculty JohM Hopkins School of Medicine Prlnclpa ~ Powers, Pyles, Sutter&. Usa MtGlffel't Verville, P.C. Project Director. Sl!fl! Patient Project, Consumers Union Patient.Safety Standing. Committee Sl.lsan· Moffatl•Bruce, MD, PhD, MBA, !'ACS Executive Director, The Ohio State UnlW!rslty's Wexner Medical Center CO-CHAIRS Ed Se,ptlmus, MD Medical Olr~or Infection Pr!!Ventlon and Epidemiology KCA and Professo1 of Internal Medicihe Te1<11s A&M Hlialth ScienCll·Center Colle.ge of Medicine, Hos pita I Corporation of America Iona Thraen, PhD, ACSW 60231 Clinical Director Family Care Servic:e line, Metrohealth Medical Center Patricia Quigley, PhD, MPH, .ARNP, CllltN, FAAN,FAANP Managl~g member of t>atticia A. Quigley, Nurse consultant., LLC teslle Schult!., PhD, RN, NEA•BC; CPHQ · ·01rector, Premier.Safety IMtitute•, Premier, Inc,. Amy Bell, DNP, RNC.OB, N!A•BC, CPHQ Quaih:v Director, Women's and Children's Services and Levine Cancer Institute, Atrluro Health Ma.rtha <:art.er, DHSc, MBA, A~RN,. CNM Chief l:xecutiVe Officer, WomanCare, Ill~. Tracy Flanagan, MO Director of Women's Health and Chair of the Obstetrics and GyneooloSY Chiefs, Kaiser Permanente Patient Safety Director, Ui:ah Department of Health VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00107 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.062</GPH> 54 60232 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Ashley Hirai, PhD Senior Scientist, Maternal and Child HHlth aurea u, Health Resci~rces and Services Admlnlstratlo~ Mlll'nbammbath Jall!el;MO Associate Profl!ssor of Pediatrics; Medical Olrector, Parkland NICU, Univenilty of Texas, Southwestern Medical Center DhmaJolles,CNM, MS, PhD Qua!~y Chair, American-College of Nunie, Midwives Debolllh Klldav, MSN Senior Performance Partner, Premier Inc,. Sarah McNeil, MD Core Faculty and Director, Contra Costa Medical Center Jennifer Moor11, Plib, RN Executive Director. Institute for Medicaid lnno~atlon Kristi Nelson, MBA, BSI\I Women and Newborns Clinical Pr<:igr~m Manager, lnterMouritaln Healthcare J. Emilio carrtUo, MO, MPH Weill Cornell Med lch:1e, Weill Comell Graduate Sthool of Medical Sciencu, Massichusetts G\!neral Hospital Catherine HM!, ONP; APRN Starlin H•vdon-Gl'eattlng, MS, as, Pharm, FAPhA Texas Health Resources Ronald Inge, ODS Delta Denul of Missouri llflnols Pharmacists Asso~ration Anne Leddy, MO, FACE Amerlca_n Association of Cllnk:al 'Er1docrinologlst~ Patricia Mc:Kan11, DVM, MPH Michigan Department of Community Health Grate lee, MO· Amy Mlnrili:h, IIN, MHSA Gelsln,er Health System Vil'!llnla Mason Medical Center Anna McColllffl!!loSllpp Galik!o Malytlcs Marclll Salhie,. MD, MPH Natlol'ial I nstltute on Aging, Jania, Milter, OI\IP, CRNI', CO£ Jll$0ft Spancler, MO, MPI! Amgen, Inc. ThoMas Jeffei5on University School of Nonilng Mat1 Stiefel, MPA; MS Kaiser Permanente Jameil llosenzv.iel11, MD Boston University School of Medicine, RTI International Georgetown University Shella Owens-Colllns, Mil, MPII; MBA Medical Director, Health Equity, iohni Steve11'Tl!Utsch, MO, MPH Cynthia Pl!llegtinl Senior Vice President, Public Polley'& GovernmentAffall'li, Marth of Dimes Sage Health Management Solutions Ann Keams, Mb, Phb Mayo Clinic MedlcalDlrector, Aetna Hopkins Healthcare, LLC V. Katherine Gray, PhD Barry.Lew.ls Ha!'fl$, II, MO Corlion Health Michael Stoto, Phb Juliet M, Nll\llns, MO, MPA l(lm Elliott, PhD Health Services .Advisory Group, Inc. Steven Strede, MD, Med, MPH, FAAFP American Academy of Family Physicians Unlvenilty of California, Los Angeles and Unlvt!nilty of Southern California Wflllam Taytor, MO ArJun Vellkatem, MO, MBA Yale University School of Mtdlclne Kimberly Templeton, Mb University of Kansu Medical Center Harvard Medical School John Ventur.,, DC Amerlca·n Chiropractic Auoelatlon Olana E. Ramo$,. Mb, MPH, FACOG Med lea I Director, Reproductive Health, Los Angeles County Public Health Department Primary Care and Chronic Illness StandlnJ Committee CO-CHAIRS Renal Standing Committee Naomi Schapiro, RN, PhD, CPNP Professor of Olnlcal Family Health Care Nursin(I, Step 2 School of Nursing, Unillerslty of Ca lifornla, Sari Fra'ndisco Dale Bl'lltzll!I', bO, MPH CO.CHAIRS University of Oklahoma Health Sciences Center-Colleije of Public Health Constance Anderson, BSN, MBA Vice President of Clinical Operations, Prevention and Population. Health Standing Committee CO-CHAIRS Northwest Kidney Centers ·Adam Thompson, BA Kennedy Health Alliancl! .torten Dalrymple, MD, MPH Vice President, Epidemiology and. Research, Fresenius Medical Care North Ame.rlca MEMBERS Thiru AnnaW111my; MO, MA VA Medical C!lnter Retired Robert Balley,('110 Johnson & Johnson Health care System$, Am_lr Qa•eem, Mb, PhD, MHA. American College of Physicians Lindsay !lotsfotd, MO, MBA, M!iA/FAAtP Thomll!S Mcinerny, MD MEMBERS Inc, Physicians at Sugar creek Rogl!I' Chou, MD Oregon Heatt·h and sciences University John Auerbach, MBA Trust for America's Hea Ith WIiiiam Curr,;, MO, MS Mlchael Baer, MO Penn State Hershey Medical Center Cotlvltl Jim Daniels, BSN Southern Illinois University RE!sldency Program lion Bialek, MPP, CQIA Pu bile ~lealth Foundation MEMBERS Rajesli DIIVda, MO, MBA, CPE National Medical Director, Senior Med lea I Director, Network Performa nee Evaluation and l·mprovement, Cigna Mealthcare Elltabetll Evans, DNP Norse Practitioner, American Nunies Association MlchUI Flsdier, MD, MSPH St;if/' Physician; Associate Professor ot Medicine, Department of Veterans Atfalni Woody Elsenbel'I, Mtl WE Managed care Consulting, tLC VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00108 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.063</GPH> 55 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Renee Garrldl, MD, FACP l'rofessor of CUnital Medicine, \lice Dean, and f\enal Section.Chief, R.~~al Phy~lelans Assoclatl<m/We$tthester Medicai Center, New York Medkal COiiege swan GN!enstein, MD Professor of Surgery, Montefloi'l!i Medical Center MlkeGufle'( Business Continuity Manager, UMB Bank (Board of Directors Treasurer, Dialysis P~tient Citizens) Debra Hain, l'hD, APIII\I, ANP•BC, GNI'• l!C,tAANP Mark Rutkowski, MD Physician Lead for Renal Clinical Practlee and Quality, Southern tallfornla l'ermanentf Mei!.Jcal Gro11p Mld'laE!I Son,en, MD Assoi:late Professor in· Pediatrics/Director; Renal iila!ysl:I Unit, Arn,ciate Chief Division of Nephrology, American Society of Pediatric Nephrology/Ha111ard Medical Sehool/8,oston Children's Hospital Bobbi Wager, MSN, RN. Rena1·car11 Coordinator, American Association of Kidney Patients Marie Jarrett, MD, MBA Chief Quality Officer, Associate Chief Med lea I Office I, Ntirth Shore-LU Health System Cllffonl. Ko, MD, MS; MSHS, FAcs; FA$CRS Director, Division of Rose.arch and Ol)tlma I Patient Care, American College of.Surgeons !'rofessor of Surgery, Department of Surgery, UCLA school of Medlclnll and Public Health 8arba.ra lllVY, MD, FACOG, FA(:S · Vice President; Health Policy, Amerlca.n College of Obstetrlcia ns and Gynecologists Associate Professor, Adult. Nurse Practitioner, American Nephrolotli Nurses' Assodatlon John Wagner, MD, MBA. Director.of Se111100, Associate Medical Director, Kings County Hospital Center Lori Hanwell President/Founder, ReMI Support Network. Joshua Zaritsky, M:D, PhD Chief of Pediatric Nephrology, Nemours/Al. du Pont Hospit.il for Amy Moyer Manager of Value Measurement, The Children Alliance Surgery Standing Committee Professor and Dean, College of Pharmacy, Unllll'!rsitv of Arkansas for Med k:a 1.sc1~nees Frederick Kaskel, MD, PhD Chief of Pedl~rlc Nephrnlogy, Vice Chair of Pediatria, Children's Hospital at Monteflore Alan klqer, MD Cllnica.1 Professor of Medicine, Yale Uni\lerslty School of Medlelne Senior \llce President Med lea IAffairs., Chief O.Ual!ty Officer, Yale New Haven He Ith System Mahesh Krlshn1111, MD, MPH, MBA, FASN tee l'lelsher, MD Professor and Chair of Anesthtslolot1Y, UniverMty of PeMsylvanla/Amerk.an Society of Anesthl!$IOloglsts .Wllllam Gun,na,, MD, JD Director, National centerfo1 Patient Safety, Veterans Health Administration MEMBERS Vice President of Clinical I nnovatlcm and Pu bile Polley, lla\llta Keah:hcare l>artners, Inc,, Professor of Surgery, Mayo Clinic Usa Latts, MD, MSPH, MBA, FACP Principal, LML Health Solutions and CMO, University of CA Health Plan. Chief Quality Officer, United States Anesthesia Partners l(arllynne ll!mlng, MHA, I.JSW Temava Eatmo11 Patleht Repl'eserttati11e SenlorQoallty Improvement Facilitator; Te111$en West Franklin Maddllll,MD,FACP E~ectiti11e Vice President for Clinical & Scientific Affairs, Chief Medical Officer, Fresenius Medical Care North America Andrew Narva, MD, FACP, FASN Director, Natlonai Kidney Disease Education Program, National Institute of lllabetes and Digestive Kidney Diseases~ National Institutes of Health .Jessli! Pavllnac, MS, RD, CSR, LO Dl«!ctor, Cl.inical Nutrition, Food & Nutrition se111ices; oreson Health & Science University LIIWl'ence Moss, MD Surgeon-In-Chief, Nationwide Chlidren's Hospital Keith Olsen, PharmD, l'CCI', FCCM CO-CHAIRS Mvra kltll'IPl!ter, MD, MPH Associate Professor of Clinical Medicine; Tulane Uniw.rsity School of Medicine. 60233 Lynn Rode, DNP, MIIA, CRNA, FNAP Chief Clinical Ofllcei, American Association of Nurse Anesthetists Christopher Saqaf, MD, MPH Professor, UCLA SIii-re T. Seal~ Mil, FACS, lll>VI. Anlstant Professor of Vascular Surgery, University of ~lorida-Gainesvme Allan Siperiteln, MD Chairman Endocrine Su!!lery, Cleveland Clinic Robl!n Cima, MD, MA Riehm! Dutton, MD, MBA. Joshua D. Stein, MO, MS Ellsabelh Erek,on, MD, MPH, FACl)G, FACS Interim Chair, Depattment ot Obstetrics and Gynecology at the. Geisel School of Medicine, Dartmouth .Hitchcock Medl~al Center Frederick Gn:wer, MD Prnfes$or of tatdlothOriclc Surgery,. Unl~erslty of Colorado.School of Associate Professor, University of Michigan, Oepartmentof Ophthalmology & lllsual Sciences, Department of Health Management & Polley, Director, Cent<!r for £YI! Policy and Innovation lBrissa Teniple, MD Cciloisectal Service, Department of .Surgery, Memorial Sloan-Kettering: Ca.ncer Center Barbee Whitaker, PhD Director, American As$oclatlon of Blood banks. AJ. Yates, MD Medicine John Handy, MD Thoracic surgeon, American coi1e1e of Chest Physicians Associate Professor and Vice Chairman for Quality Management, Department of Orthcpedic Surgery, IJnlven;lty of Pitt~burgh Modica I center VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00109 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.064</GPH> .56 60234 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Appendix C: Sdentlflc Methods Panel Roster CO-CHAIRS Joseph Hyc!A!r,MD David Cella, Phi> Professor, Northwestern University Associate Professor, Mayo Clln k: David Nerenz, Phi> Olrecwr, Center for Health Poncy and Health Se111ices Research, H,enry Ford Health System MEMBERS J. Matt AUslln, PhD .Assistant Professor, ArmstronjJ Institute for Patient Safety and Quality at Johns Hopkins Medicine IIIJan 8orah, MSc; PhD .Associate Professor. Mayo Clinic John Bott, MIA, MS$W Manager, Healthcare !lattngs, Consumer Report.I Patrick Ramano, MD, MPH Professor, University of California Sherrie Kaplan, PhD, MPH Davis Professo,r of Medicine, Vice Chancellorfor Healthcare Me.asurement and Evaluation, UC hvlri~ School. of Medicine Sam Simon, PhD :senior Researcher, Mathematica Policy Research Alex Sox-Hams, PhD, MS Joseph Kunlsch, PhD, IIN•K, CPMQ Enterprise Director of Clinical Quality Informatics, Memotllll Hermann Health System Assoclat.fl>rofessor of •Research, ·oepartrnent of Sutg.ery, Stanford University Paul Kurlansky, MD Professor of Mealth Syst~ms Administration and Population Health, Georgetown University Associate Professor of Surgery/ Associate Director, Center for Innovation and Oum1mes Research/ Director of Research, Recruitment and CQI, Columbia University, College of ~hyslclans and Surgeons/ Columbia 1-ieartSource Daniel l>eut,mer, PT, Phi> Michael Stoto, PhD Christi!! telgland, PhD Vice President, Advanced Ana lytlcs, Avalere Health Ronald Walters, MD, MBA, MHA, MS Associate Vice President of Medical Operatlons and Informatics, University of T!ll<as MO Anderson National Oitector of Research and Development, Ma¢cabi Healthcare Se111lces Zhenqlu Un, PhD Lacy Fabian, PhD Lead Healthcare Evaluation Specialist, The MITRE· Corporation Jack Needleman, PhD Professor,. University of California los MS:eles Marybeth Farquhar, Phi), MSN, RN Eugene Nuccio; PhD Assistant Professor, University of Terri Warhol•k, Phi>, RPh, CPHQ., FAPhA Assistant Dean of Academic Affairs and.Assessment and Professor ~nhe Unlversfty of Arizona, College of Colorado, Anschotz Medical Clln\p~s 'Pharmacy E~ecutlw Vice President of Resea rth, QuaI tty and Scientific Affairs, American Urological Association Jeffrey Geppert, EdM, JI> Senior Research leader, Battelle Memorial Institute Laurent Glance, MD Professor and'Vlce Chair for Research, Un/varsity of Rochester School of Medicine and Dentistry Director of Cata Management and· Analytics, Vale•New Haven Hospital •Cancer Center se,an O'Brien, PhD Eric Welnhandt, PhD, MS Associate Professor of 8iostatlstlcs Senior Director, Epidemiology and and Bioinformatles, Duke University Medical center Biostatlsties, Fl'l!senlus Medical Care North Amettca Jennifer Perloff, PhD Scientist and Deputy Oltector at the Institute of Healthcare Systems, Susan White, PhD, IIHIA, CHDA 8randels University Administrator• Ana,iytics, The lames Canter Hospital at The Ohio State University WHner Medical Center VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00110 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.065</GPH> 57 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60235 Appendix D: MAP Measure Selection Criteria MAP uses its Measure Selection Criteria {MSC) to guide its review of measures under consideration. The MSC are intended to assist MAP with identifyingcharacteristies that are associated with idealmeasure sets used for public reporting and payment programs. The MSC are not absolute rules; rather~ they are meantw provide general guidance on measure selection decisions and to complement program-specific statutory and regulatory requirements. The central focus should be on the selection of high quality measures that optimally address health system improvement priorities, fiff critical measurement gaps; andlncreasealignment Although competing priorities often need to be weighed against one another, the MSC can be used as a reference when evaluating the· relative strengths and weaknesses ofa program measure set, and how the addition. ofan individual measure.would contribute to the set. The MSC 11ave e)l()lved over time to reflect the input of a wide variety ofstakeholders, To determine whether a ·measure should be considered for a ~fled program; MAP evaluates the measures under consideration against the MSC. Additionally,. the MSC serve as the basis for the preliminary analysis algorithm. MAP members are expected to familiarize themselves with the criteria and use them to indicate their support fur a measure under~slderation. 1. NQFendorsed measures ore requiredforprogram measuresets, unless no relevant endorsed measures are available to achieve. a critical program objective Demonstrafedby a program measure set that amtains.measums that meet the NQFeilddisement criteria, including lmpoitance to measure and report, scientific acceptability of measure properties, feasibility, usability and use, .and harmonization of competing and related: measures SUocrlterion l;l MeaSU./'f!S that am notNQF-endorsedshouliJ be submitted for endorsement if. selerted ta meet a specific program need SUbcriterion 1.2 MeastJres that have hadendorse'meritremovedor have beensubrniifud Joi endotsementand'Nf!teoot endorsed should be.retnCJVetl.ftom programs Measures that are.in reserve status(i.e;, topped out) shoukl be considere!l foi removal from programs Subi:rlterionU 2. ·Program measure set actively promotes key healthcare improvement priorit:ie~ such as those highlighted in CMS'"Mea11ingfulMeasures11 Framework Oemonstratedbya program measure set that promotes improvementih key nctionaJ healthcarf/ priorities such as CMS'Meaningfu/Measures Framework. Other potential considetcitiohsinclude addressing emerging public health concerns and.ensuring that the setaddresseskeyimprovementprioritiesfordllproviders; 3. Program measure set is.responsive to sped~ program goals and requirements . . . Demonstrated by a program mtirisum set.that is '1itforpurpase"forthe partiwlarprogram . Sf1bcriteriang.J. . . . Progrom measure set includes ineosures thatareappl1cable to and approprlotefy tested for the program's intended care setting(sJ level{s) of analysis,.andpapulatiqn(s) Subcriterion 3.2 MeasutesetsJQT public reporting programs should be meaningfoifor VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00111 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.066</GPH> 58 60236 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices consumersancicpurchasers Silbafterlon33. Met1si1te.sets'{orpaymentincentive.progn1msshouldamtain measures.for wltl#t. the,:e:i$~,Jc~ri~·~f1l(Jp$tn?ting.~1ityaf15111$!1ftt/.~~e: 'Sil~U ·~ q :::t:::ai::t::;:!t:~t;;,~:;l:::::::/ Avoidselectlrilio/measuresthatOR!l~•to·~·sigpiji¢tmtadver5e •~µem:~whe.t1.I/Sl!4in{!s/i6Cijfcp,pgt'1J~ tmpti(Js/i.e,'tJduiioh~J~~mtaSJiiesWJthiivee<;Qt;fipiid/liiltloifa ·r.iWiilJilile 4. :progftim m~'t:isuteset.lficitJdesan ajiijiopiiatetn,x a/measure ti-Pet·. D#lfflOllStn,tJ?dpy·q·program ~ureset.thc,t incltu;J.es111J.C1PfJ.fr:Jpri'1te ml}(oj.~, outc:ome, eiif;ilrieni:e. of.i:ii~.Ciist/mtiurteUSe/dfJpii:Jpiiim!~;.tomj)o$i~·.andstrliifiiiiii•~necessaryfi# tlie~fitJHQ(Jl11tr1 Sct~•4J· lhf!e~l)ptef~$ftc,tili./.6eg~··tQ ~•·~·ihotii~iesss~cifti. p&,gf<!m~•· Sillictlterlon.42 .PiJblfcreportmgofpm:gitlitiitieasutese'ts·.,lildemplwsize ·outcomes that SidJc~..t.,• mafftt,:topc1tfents,·.fncJudingpc~tierft~·aric1.•ca.regf~~ou~s Pt!~tprogmm ~lilll~sho1ik!inchideouttomemeasuff1s.iittlceciw• 5;·. Pfo.gnim·.measureseteiiiJtftesmeiisiitetrfeiltiJf{ietson~ arid/i:iimly-dntefedcat~iina :serv;ces Demonstrated•bya program measurnet.·thataddresses access, drake, selfdetermlna.ticm, and eornmun(tyintegmJipn. S U ~ S.1 lllfei#tiie.set:iidd~ piitiimt/frimlly/tanig[vefeiqietiefi<;e; iildudmg .asjiii;ts ofcommunfaition and.care coc,rdincftion •~$.2 M~reset¢d.~shqr¢decisio.rim(l/d.lf9; suchds.foreai-eClf1(fsentk:e ·Pfaffriiiig!iildes~bHshin!Ja~fif;edi~ Meiisute~t~na6ies.·tmmmento/the.f,leisQn'sciiiei:ftid$eivicesaaoss. ~.521: providers, settings, and time ~i P(c)g((,lffl :measure$et filcl~sc:011$.iderotiQnsf()rllea/thfJl~ dispQrit/eS Q11cfcultqral competency p~trattfdby{l.programmeii$llr¢•·seftl1qtpro,note$equittibie•·~··dl1d-~ntpycons~rtll!J: he<1Jthcan,·dlspc1titks, Ftil:tots:iriChRJe ~mg race;. ethnkity, soiiaer:ooottiicstatus~ lal'/{lwge, gender;.sexuaforientationiage; orgeographicalconsidera.tions(e;g;, urban.vs; rural). . Program·measure Sf!tatso. can addresspopukltions t1t1:i,skjorhea/.thcaredisparities (e.g.; people with. DlihavkHrlVmental iliilfi4J. Siibt:titeiion 6.1: ~ 62: Progmmmeasure:set indudesmeasulfl ihatdirectlyassess healthcare rJiSpc1ri~·es (e,g,,. Jn.terpreter:seryi.cy!SJ P,r,gtam hWAStite. si!t JncJtiiJe$ hWASt1tatfratqrese11sitl11i!.ttnJispa~iffes. measijtement(e.g., bet?iblockettrei:it:me#taftet(iheattotwckt i:itid thot VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00112 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.067</GPH> 59 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60237 fea1itate$tmtif/«ltionof:resultsto.·betalful'Jderstlmddiffererwe$.among vumeniblepopulafkms. 7;. PrQgra111. w~ute~et proffioJes (:xJrsfiti(1ti)la1fd. aliiln:m.ent o.monstrri~dbya:progrom·measure.setthatsuppo~e/fic.ientUS11ofresaurces[ar-datt,collfflianO!ld. repr:»:#m.1ratJ#sqppt,!t$•ofigr,metJt·c,c~p~ms;.•tiie.Ptt1gro1r1~1J11tSt:tsb.puld4f;,!~tlle ~rtt.of.e/foft.~atedw.ith·~rei)'liint,1J;dhis,Qfipprf(ifilfyt<Jimr,t!NequtilJty; ~ · i . i . ·Progrom:measute.setil~tmtes.e.jficiimey(te:,miiitmurnnfiirlbe.toi· .meas.u.res,om!tttelelJsr~~~tiiatoctt~p;x,gtQ:trtgtit~J· ~ • ' i i , Ptclflrt1m~~~t~s~ ~p/tti$/$qt:t~~ t/lat.ttxJbi{~ . ~ multiple.phlgfamsJ,f.appllaitkin$ · VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00113 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.068</GPH> 60 60238 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Appendix E: MAP Structure, Members, Criteria for Service, and Rosters MAP operates through a two-tiered structure. Guided by the priorities and .goals of HHS' National Quality Strategy, the MAP Coordinating Committee provides direction and direct input to HHS; MAP's workgroups advise the Coordinating Committee ori measures needed for specific care settings, care providers, and patient populations. Time-limited task forces consider more focused topics, such as developing "families of measures"-related measures that cross settings and populations-and provide further Information to the MAP Coordinating Committee and workgroups. Each multistakeholder group Includes Individuals with content expertise and organizations particularly affected by the work. MAP's members are selected based on NQF Board-adopted selection criteria, through an annual nominations process and an open public commenting period. Balance among stakeholder groups is paramount. Due to. the tomplexity of MAP's tasks, individual subject matter experts are included in the groups•.Federal government ex officio members are nonvoting because federal officials cannot advise themselves. MAP members serve staggered three0 year terms. Jeff Schiff, MD, MBA MAP Coordinating Committee Cardinal Innovations Ron Walters, MD, MBA, MHA Gelsinger Health Bruce Hall, MD, PhD Federal Government U.ilsohs (non-voting) ·lnte!'llloul!taln Healthcare BIC HealthCare Agency for Healthcare llesean:h and Minnesota Community Measurement Charle$ l(MII, II~ MPH Federation of. American Hospitals Quality Nallo11al Association Of Rural Health Cllnlc:s Committee Co•Chairs (voting) Organizational Members Michigan Center For Runl Healih Centel':$ for Disease ·contn:ll llftd llreventlon Na!IOllal Rural Health Allsl!l:lallon Centel':$ for Medicare and Medicaid Senilees Nallonal Rural t.etterOlrrl!in' Assoclatlcn Office of the National Coordlrtlltor for Health Information Technolccv RUpri Center For Rural HO'alth Pelley Analysis American Medical Association· MAP Rural Health Workgroup Members 'l'ruven Health Analytics UC/l!IM Watson Health Company American Mll\les AHOCIIIIIOli Committee Co-Chairs (voting) (voting) America'II. Health Insurance !>lam, American College Of Physlc:la11s American Health care Assodatlon American HoSpjlal A$$0Cl111iOII Health Care Service Corporation Rural Wlscom,ln Health Cooperative Humana Allron·Ga.rrilan, MD Colli Country Community lieah:h The Jotnt Commission Center Individual Subject Matter Experts (voting) Michael Fadden, MD John Gale, MS Ira Moscovlce, PhD· The leapfrog GtcUp Cul'lls Lowery, Ml) Unlver.1~y tif Minnesota School of Medicare Rights CentA!r · National iluslness Group OIi Health National .Committee For· Quality Assurance Nation al Patl.e11t Advocate Foundation Network For Regional Healthcare Improvement Pacific Business Group On Health l'ath,nt & Famnv Cli!llt<1tred Care Pal'llll!I'$ Public Health Me-nda Murphy, RN, MS Organizational Members (voting) Jeslllca Schumacher, PhD Alliant Health Solutions Hlllly Wolff, MHA American Academy Of Family PhY$1cial!S Federal Goverhrnent liaisons (non-voting) American Academy Of l>byslclllft Federal Office Of Rul'lll Health Polley, DHHS/HRSA Ana Vertone, MS,AP!lN, FNP, c.NM Allolstants American Collqe Of Emergency Physicians Centerfor Medicate and Medicaid Innovation, CHters for Medicare and Medicaid Seniices Americllft Hospital AsllOClatlon individual Subject Matter Experts (voting! American Sodety Of Health-System Pharma11lsts Indian Health Services, DHH Harold l'lncus, Mb VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00114 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.069</GPH> 61 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Members MAP Clinician Workgroup MAP Hospital Workgroup Members Centers for Disease Control and l'reventlon Committee co-Chairs (voting) committee Co-Chairs (voting) Centers for Medicare al'ld Medicaid 5el'llll:es llruce llagley, MD I!. Sean Morrison National Coalition for Hosplel! and Palliative Care Organizational Members (voting) TheAIHanc, America's Physician Groups American Academy of Fli!llllv Phy!iclans Cristie Upshaw TnlVls, MSHHA Memphis Busiryess Group on Health Organizational Members (voting) MAP Post-Acute Care/Long~Term Care Workgroup Committee Co-Chairs (voting) America's Essential Hospitals Gerri Lamb, PhD Arizona State University American As,soclatlon of l<ldlley Patients Kurt Ml!fkefz, MD Compass us Amerlc.an Case ManlCE!ment Association Organizational Members (voting) American Collea& of Radlofogv American Hospital Assoclat11m American Oecupatlonal Therapy AHociatlon American Society of Anestheslolcglsts AMOA~ The Sodety for Post-Acute and l.ong,Term care .Medicine Anthem A.ssodatlon of American Medical eoneen cttyof Hope American Academy of Pediatrics American Association of Nurse Practitioners American College of Cardiology Atrium Health Consumers' CheckboOk/Center for the Study of Services Cc,undl of Ml!dlcal speclalw Societies Genentech Henry Ford Hllllllh SystE!mS 11rtermc,u111a1n He,althcilre. 1.oulse.Bati Patlel'lt Sa'1!ty foundation Medtronlc,Mlnlmalfy Invasive Therapy Group National Assodatlon of ACOs hclflc Buslne$$ Group on H1111l1h American Otcupatlonal Therapy Association American Physical Therapy Association Centme, Corpomtlon Greater New Yofk Hospital Association Kaiser Permanente Mq;eHan Health, Inc. American Academy of Physical Medicine and Rehabilitation American Geriatrics Society Dialysis Patient Cl1lzens HealthPartners, Inc. Kindred Hl!althtaNI National Hosplc11 and PalRatlve Care Orcanliatl0n Molina HHlthcare Mothers Acalnst Medical Error PatlE!nt.Centered Primary Care Collaborative National Assodatlon for Behavioral Healthcare (formerly National Association of Psychiatric H®lth l'atlent Safl!ty Action Network Systems) St. Louis Area ludness Health Pharmacy Quality Alliance Coalition ·National Piinnership :fol' Hospice Innovation Nat1011al PN!$$ure Olcl!r Advisory Pan11I National Transhlons of car• Coalltli:!n Vlsltina NurtE! Associations of America PrE!mh1r, Inc. PressGanet Individual Subject Matter Experts (voting) ProJtct Patient Cam Sarah U\llluy, DNP, RN, ACNP·BC. CNS•BC WIiiiam Fleischman Sl!l'Vlce Employees lntematlonal Union Stephanie Fry Sodetyfor Matemal-Feial Medicine Paul Mulhausen, MD federal Government Liaisons (non-voting) IJPMC Health Plan Eugene Nuccio,. PhD Individual Subject Matter Expert$ (voting) Ashlsh Trivedi, l>harmi> Individual Subject Matter Experts (voting} Nlshant «Shaun• Anand Centers for Disease Control and PmvE1ntio11 (CDC) Centen for Medicare and Ml!dlcald Sen,lcu (CMS) Health Resources and Services Administration (HRSA) 60239 Rikki Manirum, MLS federal Government Liaisons (non-voting) Andmea !lalan-Cohen,, PhD Unilsey Wisham center tor Disease Control and Prevention Centers for Medicare, and Medicaid federal Government Liaisons (non-voting) Services Acency for Healthcare Research and Quality Offl~· of the National Coordlna10, for Health Information Technolcgy VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00115 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.070</GPH> 62 60240 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Appendix F: Federal Quality Reporting and Performance-Based Payment Programs Considered by MAP 1. 2, 3. 4; S. 6. 7. S, 9. 10. 11. 12. 13, 14. 15. 16. n 18. Ambulatory Surgical Center Quality Reporting Program End-Stage Renal Disease Quality Improvement Program Home Health Quality Reporting Program Hospice Quality Reporting Program Hospital Acquired Condition Reduction Program Hospital Inpatient Quality Reporting Program and Medicare and Medicaid Promoting Interoperability Program for Eligible Hospitals and Critical Access Hospitals Hospital Outpatient Quality Reporting Program Hospital Readmission Reduction Program Hospital Value-Based Purchasing Program Inpatient Psychiatric Facility Quality Reporting P.rogram Inpatient Rehabilitation Facility Quality Reporting Program Long-Term Care Hospital Quality Reporting Program Medicare Sha.red Savings Program Medicare Part C & D Star Ratings Merit-8.ased Incentive Payment System Prospective PaymentSystem Exempt Cancer Hospital Quality Reporting Skilled Nursing Facility Quality Reporting Program Skilled Nursing Facility Value-Based Purchasing Program VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00116 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.071</GPH> 63 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60241 Appendix G: Identified Gaps by NQF Measure Portfolio In 2019,. NQF's standing committees identified the following measure gaps-where high value measures are too few or nonexistent to drive improvement-across topic areas for which measures were reviewed for endorsement. All-Cause Admissions and Readmi11slons Due to change in cydes, no measure gaps were identified. B.ehavloral Health and Substance Use • Measures that focus on social determinants of health (e.g. housing, employment, criminal justice issues) • Care coordination across the life span • Full course of the wellness/illness continuum (i,e., from prevention to prodromal to illness and recovery) · • Measures that focus on recovery, overall well-being, and total cost of care, including composite measures • Patient goal measures that are precisely paired with functional outcomes • Measures that focus on provider "burnout" including those tied to payer-managed care (e.g., prior authorization, treatment limits) • Measures that focus on care integration between menta I health, substance use disorders, and physical health (e.g., primary care). • Over-prescription of opiates Cancer Due to change in cycle,. no measure gaps were identified Cardl.ovascular Due to change in cycle, no measure gaps were identified Cost and Efficiency Due to change in cycle, no measure gaps were identified Geriatric and Palliative Care Due to change in cycle, no measure gaps were identified Patient Experience and Function Due to change in cycle, no.measure gaps were identified Patient safety Due to change in cyde, no measure gaps were identified Perinatal and Women's Health • Postpartum depression • ;'Churn" (coming on and off) of healthcare coverage • HPVvacdnations for males and for people upto age 45 • Percentage of minimally invasive hysterectomies • Intimate partner violence • Disordered eating • Burden of caregiving • Fibroids • Endometriosis VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00117 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.072</GPH> 64 60242 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices • • • • • Pain Social determinants of health Social support, particularly during pregnancy and the postpartum period Prenatal depression/anxiety Appro.priate weight gain during pregnancy Neurology Due to change in cyde, no measure gaps were identified Pl'.f!Wntion and Population Health Due to change in cyde, no measure gaps were Identified Primary Care and Chronic Illness Due to change in cycle, no measure gaps were Identified Renal Due to change in cycle, no measure gaps Were identified Surgery Due to change in cycle, no measure gaps were identified VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00118 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.073</GPH> 65 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60243 ~ndix H:. Mecticare Measure Gc1ps Identified by NQF~s .MeclSUl'e Applications Part11etship During its 201lF2019 deliberations; MAP identified the fulloWing measure.gaps"'-where. high value meas1Jres. are too few or nonexistent tQdriv:e lmprovement--fur Medicare programs fur tiospltals and hQspital~ngs; ~Nicute. care/iong-temi care settings, and. dinh:ians. End-Stage Renal Disease Quality lnoentlve Proeram {tSRO QlP) PPS.Exempt:Cance.r·Hospltal·Quallty Reporting (PCHQR) Program • " • Assessment of quality ofpediatrk: dialysis Management. ofcmnorbkl.condltions (e,g.,congestive heart fallure, diabetes, and hypertension} Measures.that assess safety events broadly {I.e., a measure of gfobat harm) • • • Ambulatory•SUrgery Center .quality REl!POl'tlng (~~) Progrl!fll • • Inpatient Psych/~rit Facility Quality Rej:u:irtlrig Pi:ograni {IPFQR) Program Pat!ent-repol'tEl!d outcomes Comparisons of surglcalquality across sites of care lnfectii>ns and .complications Patient and famhyengagEl!ment Effltlency measures, lncludingapPropi'iate ~rative testing ., Medk:al tomorbldlt!es Quality of psychiatric care provided in.the Emetgentj' Oepariment for patients n(it adrnlttedto the hospital Pischarge planning Condltfo.n-sJ.1edflc readmission measures Hospital OUtpatlent Quality Reporting {OQR Program .• Communication and.care.coordination • • Falls Accuraie.dlagoosls flospltal Inpatient Quality ~porting (IQR) Program and Medk:are andll/ledicaid Promoting lnteroperabDlty Program • • Pa:tient-reported outceimes Dementia • • Adversedrug events Stlrgical site lnfettlons in additional locations • • • • CompOSltemeasures to address multiple aspects oh:are quality Outcome measures Measures that allow a broad range ofdin1cians to report data Composite measuresto address, multiple asP¢cts of care quality • • • HospltatReadml~ons REl!ductlon Program (HRRP) Hospital Value-Based Purchasing Prograrri (Vllfl~ Hospital-Acquired Condition Reduction Program (HACRP) Merit-Based Incentive Payment System (MIPS) Medicare. Shared.Savings Program Inpatient Rehabllitation Facility Q.uallty Reporting·•Program(IRFQRP} Long-Term care Hospital Quality Reporting Program (LTCH QRP) • Transfer of patient Information • • Appropri~eclinlcal.useof aplolds Refinements to i:;utrent infeetlon measu~ • Men.tal.and behav!otal health VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00119 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.074</GPH> 66 60244 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices Skilled Nursing FacifityQuality Reporting Program {SNF QRP) • • • • • Bidirectional measures Efficacy of transfers from acute care hospitals to SNFs Appropriateness of transfers Patient and caregiver transfer experience Detailed advance directives Skilled Nursing Facility Value-Based Purchasing Program {SNF VBP) • None discussed Hometlealth Quality.Reporting Program • (HH QRPj • Measures that address social determinants of health New measures to addressstabil.ization of activities. of dally living Hospice Quality Reporting Program (HQRP) • • • • • • • Medication management at the end of life Provision of bereavement services Effective service delivery to caregivers Safety Functional status Symptom management; induding pain Psychological, social, and spiritual needs VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00120 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.075</GPH> 67 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices 60245 Appendix I: Statutory ~equirenient of Annual Report Components This annual report, NQF20l 9Activltles: Report to Congre$S and.the Secretaryofthe.Deportment of H.ealth and Numrin Servlces:1 highlightsand sui:nmarizes thewOl'k ttiat NQF perfurmed bet\YeenJ~nuary land December 31, 20:tiu:ndet contrict with the u.s: Department ofHealth and Homal:i Servk:es (HHS} in the following six areas: • • • • • • Recommendations on the f\latronai Quality Strategy and Priorities; Quality and Efficiency l\lleasorement tnitiatili:es (Perfurmance 1\/!easures); Stakeholder ~mmendations on Quality and Effidem:y Measures; Gaps.on EridotiiedQoality and Effidel'lcy Measutes across HHS Programs; Gaps ln Evidence and Targeted Research Needs; and Cootdination withMeasorementlnitiatives by Other Payers. Congress has rec6gritl:ed the role of a "rooseoois based entity'' (CBE), cuirently NQF,. ln helpiogcto forge agreement across the publlc and private.sectors about what to measure and improve in healthcare; The 200$ Medlt.:ire Improvement$ for P.itlents a1nf ProvldE!rs Act (MIPPA) (Pl 110-275) establisfled the responsibllitiefofthe :eonsensus,ba~ entity by ereatiri~se:etionl800oftheSocial SetorityAct. The 2010PatientProte:etfon and Affordable Care Act (ACAl (Pl 111·148)modified and added to the CQnsensus-based entity's respom;ibilitles. 'The American Taxpayer Relief A:etof 2012 (Pl 112-24o} extended funding under the MlPPAstatute to the consensus-based entity through fiscal year 2013. The Protecting Access to Medicare Ad of 2014 (Pl1f3-93} extendedfuoding under the MIPPAand ACA statutes to the. ci:i11!iel'ii!OS0based entity through March 31, 2015:. ~on 207 of the lllledicare Ao:ess .and Children's Health Insurance Program {CHIP} Reauthorizatioo Act of 2015 ·(MACRA) (Pl114-10J extended funding undE!r sectjC1n 1890(d)(2) of the:Sodal Security .Act for qualify i:ne~sure endC>Bementjlnpu~, and selection for fi$cill years..201SthroOgh 2017. Section 50200ofthe Bipartisan BOdget Act of2018 extended funding for federal quality efforts for.two years(October 2017- September 201~)amoog other requirements. Bipartisan actlon·by numerous Congresses over several years has reinforced the Importance of the role of the CBE. In a:CCOl'dance with section 1890 of:the Social Security Act, NQF, In its designation as.the CBE; is chatgedto report annually.on its work to Congress and the HHS Secretary. As.amended by the.above laws, the Social Security Act (theAct)-sfXldfttai/ysectfon 1890(b)(S)(A)mandatesthat the entity report to °"1gre$S and. the Secretary ofthe Deportment of Healthandfluman Sei\lk:es (HHS) no later them Match 1st of each year. The report must Jll(;fude descriptions of: • • • • howNQF has implemented quality anclefficiem:y rti«lsurementirilti<ttives undetthe Act am:/ coordinated.these initiatives with Nloseimplemented by other payerst NQf's recomme(l:datkmswith respect to.anlntegra.ted national strotegy amfprfotities fix healthcare fXlrfarmam:e measurementin. all applicable settings; NQPs pe,formance of the duties required underits amtractwith HHS IAppendix A}; gaps in endorsed quality.and efficiency measures; JncJuding measures that are within priority at'eas identified by the ~cretaty under HHS' national strategy, ar,d wheN! quality and ejfit;iency meo.sures areunavi:1ilabte. ot1Md¢4®teto.identW of address such gaps; areas Jn which evident:e ls insufficient ta support ei'!!Jorsement ofmeasutesln priority ate(IS: 1Wntified by the National auality5ttategy,. <Ind wheht tatgetedteseardr mtrY addresuuch gaps; [FR Doc. 2020–21103 Filed 9–23–20; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Delegation of Authority Notice is hereby given that I have delegated to the Administrator, Health Resources and Services Administration (HRSA), or his or her successor, the authorities that are vested in the VerDate Sep<11>2014 17:00 Sep 23, 2020 Jkt 250001 PO 00000 Frm 00121 Fmt 4703 Sfmt 4703 Secretary of Health and Human Services under sections 1833(bb) and 1834(o)(3) of the Social Security Act (42 U.S.C. 1395l and 42 U.S.C. 1395m(o)(3), respectively), as added by section 6083 of the Substance Use—Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, Public Law 115–271. This authorizes the HRSA Administrator, on behalf of the E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE20.076</GPH> •

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 85, Number 186 (Thursday, September 24, 2020)]
[Notices]
[Pages 60175-60245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21103]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[CMS-3378-N]


Secretarial Review and Publication of the 2019 Annual Report to 
Congress and the Secretary Submitted by the Consensus-Based Entity 
Regarding Performance Measurement

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY:
     This notice acknowledges the Secretary of the Department of Health 
and Human Services' (the Secretary) receipt and review of the National 
Quality Forum 2019 Annual Activities Report to Congress and the 
Secretary submitted by the consensus-based entity under a contract with 
the Secretary as mandated by the Social Security Act (the Act). The 
Secretary has reviewed 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 the Act. 
This notice fulfills the statutory requirements.

FOR FURTHER INFORMATION CONTACT:
     Michelle Geppi, (410) 786-4844.

SUPPLEMENTARY INFORMATION:

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

[[Page 60176]]

(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.
    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. Additionally, 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, 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 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 Congress to include the following: (1) An itemization 
of financial information for the previous fiscal year ending September 
30, 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 
Congress and the Secretary of HHS 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 receipt.
    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 2019 activities to Congress and 
the Secretary on March 2, 2020. The Secretary's Comments on this report 
are presented in section II. of this notice, and the National Quality 
Forum 2019 Activities Report to Congress and the Secretary of the 
Department of Health and Human Services is provided,

[[Page 60177]]

as submitted to HHS, in the addendum to this Federal Register notice in 
section III.

II. Secretarial Comments on the National Quality Forum 2019 Activities: 
Report to Congress and the Secretary of the Department of Health and 
Human Services

    Once again, we thank the National Quality Forum (NQF) and the many 
stakeholders who participate in NQF projects for helping to advance the 
science and utility of health care quality measurement. As part of its 
annual recurring work to maintain a strong portfolio of endorsed 
measures for use across varied providers, settings of care, and health 
conditions, NQF reports that in 2019, it updated its measure portfolio 
by reviewing and endorsing or re-endorsing 110 measures and removing 41 
measures.\1\ 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.
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    \1\ National Quality Forum (NQF) (February 28, 2020) NQF 2019 
Activities: Report to Congress and the Secretary of the Department 
of Health and Human Services. Final Report, p. 15 (https://www.qualityforum.org/Publications/2020/02/2019_Annual_Report_to_Congress-2147382169.aspx, accessed 3/20/2020).
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    In addition to endorsing measures and maintenance of endorsed 
measures, NQF also worked to remove measures from the portfolio of 
endorsed measures for their 14 projects related to the topics discussed 
in the previous paragraph for a variety of reasons, such as: Measures 
no longer meeting endorsement criteria; 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.\2\ 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 HHS 
initiatives, such as the Meaningful Measures Initiative at the Centers 
for Medicare & Medicaid Services (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.
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    \2\ NQF, February 28, 2020, op. cit. p. 8.
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    NQF uses its unique role as the CBE to undertake a partnership with 
CMS to support the Core Quality Measures Collaborative (CQMC). Convened 
by America's Health Insurance Plans (AHIP), the CQMC is a public-
private coalition, with representation by medical associations, 
specialty societies, public and private payers, patient and consumer 
groups, purchasers, and quality collaboratives. The CQMC aims to 
identify high-value, high-impact quality measures that promote better 
outcomes. The CQMC supports nationwide quality measure alignment 
between Medicare and private payers and in turn, advances the ongoing 
work to establish a health quality roadmap to improve reporting across 
programs and health systems, as referenced in the recent Executive 
Order on Improving Price and Quality Transparency in American 
Healthcare to Put Patients First.\3\ To date, CQMC has convened 
workgroups and developed eight (8) core measure sets to be used in high 
impact areas, including those for the topics of primary care/
accountable care organizations/person-centered medical homes, 
cardiology, gastroenterology, HIV/Hepatitis C, medical oncology, 
obstetrics/gynecology, orthopedics, and pediatrics.
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    \3\ The White House Executive Order, June 24, 2019: https://www.whitehouse.gov/presidential-actions/executive-order-improving-price-quality-transparency-american-healthcare-put-patients-first/.
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    Recognizing the importance of public-private collaboration, the 
CQMC's work enhances measure alignment and reduces provider burden. CMS 
awarded NQF a 3-year contract in September 2018 to support the CQMC's 
work to update and expand the core sets. In 2019, NQF convened all of 
the eight CQMC workgroups to update the core sets and discuss 
maintenance of the core sets. In addition, NQF updated and finalized 
the principles for selecting measures for existing and new core sets, 
based on the input of the workgroups. During the same period, NQF also 
developed the approaches for prioritizing the topics or areas for 
potential new core sets. Through its partnership with NQF, CMS has 
contributed to the CQMC by making sure that the core sets drive 
innovation, reflect evidence-based care, and are meaningful to all 
stakeholders. The work of the CQMC to develop core measure sets 
addresses widely recognized and long-standing challenges of quality 
measure reporting and helps to align quality measurement across all 
payers, reducing burden, simplifying reporting, and resulting in a 
consistent measurement process. This in turn can result in reporting on 
a broader number of patients, higher reliability of the measures, and 
improved and more accurate public reporting.
    Facilitating measure alignment across payers and reducing provider 
burden 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 appreciate the 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.).

IV. Addendum

    In this Addendum, we are setting forth ``The 2019 Annual Report to 
Congress and the Secretary: NQF Report on 2019 Activities to Congress 
and the Secretary of the Department of Health and Human Services.''

    Dated: September 18, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
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[FR Doc. 2020-21103 Filed 9-23-20; 8:45 am]
BILLING CODE 4120-01-C

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