Federal Register, Volume 89 Issue 170 (Tuesday, September 3, 2024)

[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71284-71371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19479]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3447-N]


Secretarial Review and Publication of the Consensus Based Entity 
Report of 2023 Activities to Congress and the Secretary of the 
Department of Health and Human Services

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

ACTION: Notice.

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SUMMARY: This notice acknowledges receipt and review by the Secretary 
of the Department of Health and Human Services (the Secretary) of the 
2023 Consensus Based Entity Annual Report to Congress as mandated by 
section 1890(b)(5) of 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.

FOR FURTHER INFORMATION CONTACT: Charlayne Van, (410) 786-8659.

SUPPLEMENTARY INFORMATION:

I. Background

    The United States (U.S.) 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 (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 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 include 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.
    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

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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.
    Removal of Measures. Section 102(c) of Division CC of the 
Consolidated Appropriations Act, 2021 (Pub. L. 116-260) amended section 
1890(b) of the Act to permit the CBE to provide input to the Secretary 
on measures that may be considered for removal.
    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 (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 
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 
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 receiving it.
    This Federal Register notice implements the statutory requirement 
for Secretarial review and publication of the CBE's annual report. The 
CBE submitted a report on its 2023 activities to Congress and the 
Secretary on February 26, 2024. The Secretary's Comments on this report 
are presented in section II of this notice, and the CBE's 2023 
Activities Report to Congress and the Secretary is provided, as 
submitted to HHS, in the addendum to this Federal Register notice in 
section IV.

II. Secretarial Comments on the CBE's (Battelle Memorial Institute) 
2023 Activities: Report to Congress and the Secretary of the Department 
of Health and Human Services

    As part of its core mission, HHS seeks to stabilize and improve the 
quality of health care throughout the country. In response to recent 
public health crises and to prudently prepare for imminent threats in 
the future, HHS must continue to focus on advancing equity and 
inclusion, strengthening public trust, and building meaningful 
engagement and learning across the health care system. By embedding the 
cross-cutting principles \1\ of equity, public trust and collaboration 
into its diverse programs and initiatives, HHS is working to improve 
the health and well-being of individuals and families. The following 
comments are regarding the 2023 activities performed within the 
Partnership for Quality Measurement (PQM) forum, created by Battelle in 
its capacity as the CBE.
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    \1\ HHS Strategic Cross-Cutting Principles available at https://www.hhs.gov/about/strategic-plan/2022-2026/overview/index.html.
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    Over the past year, the CBE has supported HHS' commitment to 
promoting a resilient, high value, and safe health care system for all 
Americans. In 2023, HHS supported the work conducted by the CBE to 
identify health care quality measurement priorities and to provide 
consensus-based recommendations about measures to use for assessing and 
improving quality. As the new CBE beginning in 2023, Battelle 
established the PQM and continued the use of rigorous standards to 
review measures for quality measure endorsement and maintain highly 
reliable and scientifically sound measures across priority health care 
topic areas.
    The PQM is comprised of diverse representatives in health care that 
engage with the health care quality improvement community. Members of 
the PQM help shape the future of health care by taking an active role 
in the quality measurement process, using

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their health care experiences and/or professional expertise to review 
and provide feedback on quality measures HHS is considering for use in 
Medicare programs. The CBE's processes have evolved with a renewed 
focus on advancing measurement science, ensuring transparency, and 
increasing diversity in engagement of interested parties as evidenced 
by its Annual Report and feedback received by the Centers for Medicare 
& Medicaid Services (CMS). This focus has resulted in increased 
engagement from patients, patient advocacy groups, and clinicians, as 
well as a shared sense of ownership.
    The CBE focused on four key initiatives, including Endorsement & 
Maintenance (E&M) of clinical quality measures, Pre-Rulemaking Measure 
Review, Measure Set Review and Core Quality Measures Collaborative 
(CQMC). In 2023, the CBE completed three endorsement cycles. A combined 
81 measures were submitted for endorsement consideration in the first 
two cycles (Fall 2022 and Spring 2023) that were started under the 
previous CBE. The third cycle (Fall 2023) which launched the revised 
process, began in October 2023 and was completed in March 2024.
    Over the past year, the CBE expanded committee and public 
engagement by creating five new project committees that are focused on 
a patient's journey through the health care system. A description of 
these five new committees can be found on the CBE's website at https://p4qm.org/EM/projects. The committee structure is not based solely on a 
health care condition or disease state but by the type of function the 
health care system is performing (for example, prevention/screening, 
advanced illness, and post-acute care), including the type of evidence 
submitted in support of that function (for example, screening results 
in a referral). The focus areas of the committees include primary 
prevention; initial recognition and management; management of acute 
events, chronic disease, surgery and behavioral health; advanced 
illness and post-acute care and cost and efficiency.
    HHS recognizes that, concurrent with the CBE's efforts to engage 
the quality measurement community on enhancing the E&M process, the CBE 
engaged the same community on ways to create a more transparent and 
impactful measure review process to support quality reporting and 
value-based purchasing programs as evidenced in the CBE's Annual Report 
and feedback received by CMS. Like E&M, enhancements were centered 
around increasing efficiency in the process while expanding committee 
and public engagement. HHS believes that these process enhancements 
resulted in increased quantity and quality of the feedback CMS received 
on quality measures.
    The CBE convened the CQMC Full Collaborative in late 2023 to set 
priorities for the upcoming year. The goal of the meeting was to 
explore the CQMC's role in three key areas, including health equity 
measurement, movement to digital measures and alignment around 
measurement models. In addition, the CQMC discussed the leading 
barriers to adoption of measures within the core sets and achieving the 
desired impact of the core sets and how these can be overcome. The CQMC 
also began to develop a vision and strategy for the next phases of 
work.
    HHS and the CBE both recognize the importance of clinical quality 
and cost/resource use measures in improving U.S. health care. 
Maintaining these measures through transparent, periodic, and 
consensus-based reviews is critical for ensuring health care quality 
performance can not only be measured but can also be improved upon. HHS 
and the CBE recognize that a true consensus process must be 
transparent, reliable, and equitable. The CBE is building relationships 
within the health care quality community, including patients and 
clinicians, necessary to advancing the national goal of attaining the 
highest level of health and wellness for the widest range of 
individuals possible as evidenced by its Annual Report and feedback 
received by CMS.

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 publishing the CBE Report on 2023 
Activities to Congress and the Secretary of the Department of Health 
and Human Services, as submitted to HHS.

Xavier Becerra,
Secretary, Department of Health and Human Services.
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[FR Doc. 2024-19479 Filed 8-28-24; 4:15 pm]
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