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


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[CMS-3402-N]


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

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

ACTION: Notice.

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

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

I. Background

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

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

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

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

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harmonization between similar measures; replacement of outdated 
measures with improved measures; and lack of continued need for 
measures where providers consistently perform at the highest level). 
This continuous refinement of the measures portfolio through the 
measures maintenance process ensures that quality measures remain 
aligned with current field practices and health care goals. Measure set 
refinements also align with the HHS initiatives, such as the Meaningful 
Measures Framework at CMS. CMS is working to identify the highest 
priorities for quality measurement and improvement and promote patient-
centered, outcome-based measures that are meaningful to patients and 
clinicians.
    Throughout 2020, NQF continued the important work of building 
consensus from stakeholders on strategies to leverage quality 
measurement to improve health outcomes. The COVID-19 PHE has glaringly 
exposed and exacerbated pre-existing health care 
disparities.<SUP>1 2</SUP> Social determinants of health (SDoH) are 
crucial factors in health outcomes, and significant health disparities 
persist. The COVID-19 PHE has further illustrated longstanding health 
inequities with higher rates of infection, hospitalizations, and 
mortality among black, Latino, and Indigenous and Native American 
persons relative to white persons. Equity is not a new challenge, but 
despite past efforts, disenfranchised groups continue to experience 
worse health outcomes. Providing the highest quality of care is only 
possible, if we deliver equitable care.
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    \1\ Zelner, J., R. Trangucci, and R. Naraharisetti, et al 
(November 21, 2020). Racial Disparities in Coronavirus Disease 2019 
(COVID-19) Mortality are Driven by Unequal Infection Risks. Clinical 
Infectious diseases, claa1723. https://doi.org/10.1093/cid/ciaa1723
    \2\ Ortiz, N., and D. Flamini (May 1, 2020) Does COVID-19 
discriminate? Experts Discuss Pandemic's Effect on Minority Groups. 
(https://www.nbcmiami.com/news/local/does-covid-19-discriminate-experts-discuss-pandemics-effect-on-minority-groups/2227096/, 
accessed 2/24/2021).
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    CMS strives to understand and address repercussions of the COVID-19 
PHE on disparities. CMS has continued to leverage its partnership with 
NQF, recognizing NQF's unique role as a CBE and its experience 
developing multi-stakeholder consensus. In 2020, CMS funded a project 
that focuses on quality measures for assessing the impact of telehealth 
on rural health care system readiness and disaster-related health 
outcomes. Another new project focuses on best practices for functional 
and social risk adjustment, including potential data sources other than 
those currently used by developers. CMS also funded a new project on 
quality measures that could encourage collaboration between the health 
care and non-health care sectors, like social work, public safety, and 
criminal justice to combat polysubstance use among opioid users with 
behavioral health conditions.
    NQF also continued to carry out several CMS-funded projects awarded 
before 2020 for which health equity is front and center (for example, 
the Maternal Morbidity and Mortality project and the Social Risk Trial 
to galvanize stakeholders' efforts to reduce disparities by closing the 
performance gap.
    Facilitating health equity across settings and payers is just some 
of many areas in which NQF partners with HHS to enhance and protect the 
health and well-being of all Americans. Meaningful quality measurement 
is essential to the success of value-based purchasing, as evidenced in 
many of the targeted projects that NQF is being asked to undertake. HHS 
greatly appreciates the ability to bring many and diverse stakeholders 
to the table to unleash innovation for quality measurement as a key 
component to value-based transformation. We look forward to continued 
strong partnership with the NQF in this ongoing endeavor.

III. Collection of Information Requirements

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

    Dated: August 23, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
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[FR Doc. 2021-18485 Filed 8-26-21; 8:45 am]
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