[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.

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SUMMARY:
     This notice acknowledges the Secretary of the Department of Health 
and Human Services' (the Secretary) receipt and review of the National 
Quality Forum 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

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(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]
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