Notice2025-11865

Secretarial Comments on the CBE's (Battelle Memorial Institute) 2024 Activities: Report to Congress and the Secretary of the Department of Health and Human Services

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Published
June 27, 2025

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This notice acknowledges the Secretary of the Department of Health and Human Services' (the Secretary's) receipt and review of Battelle Memorial Institute's, the consensus-based entity (CBE) under a contract with the Secretary, 2024 Annual Activities Report to Congress, as mandated by section 1890(b)(5) of the Social Security Act (the Act). The Secretary has reviewed CBE's 2024 Annual Report 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. Although the Act requires the Secretary to review and publish the report, this statutory obligation does not constitute endorsement by the Secretary of the CBE's annual report and its specific recommendations.

Full Text

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<title>Federal Register, Volume 90 Issue 122 (Friday, June 27, 2025)</title>
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[Federal Register Volume 90, Number 122 (Friday, June 27, 2025)]
[Notices]
[Pages 27542-27613]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11865]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3467-N]


Secretarial Comments on the CBE's (Battelle Memorial Institute) 
2024 Activities: Report 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 the Secretary of the Department of 
Health and Human Services' (the Secretary's) receipt and review of 
Battelle Memorial Institute's, the consensus-based entity (CBE) under a 
contract with the Secretary, 2024 Annual Activities Report to Congress, 
as mandated by section 1890(b)(5) of the Social Security Act (the Act). 
The Secretary has reviewed CBE's 2024 Annual Report 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. Although the Act requires the 
Secretary to review and publish the report, this statutory obligation 
does not constitute endorsement by the Secretary of the CBE's annual 
report and its specific recommendations.

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

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 (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

[[Page 27543]]

programs in Section 1890(b) of the Act. The below comments are 
regarding the 2024 activities conducted by Battelle as the CBE during 
that time.
    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, pursuant to section 1890(b)(1)(A) of the Act, 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, 
pursuant to section 1890(b)(1)(B) of the Act, 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. Under section 1890(b)(2)(A) through (B) of 
the Act, 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.
    Removal of Measures. Section 102(c) of Division CC of the 
Consolidated Appropriations Act, 2021 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 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. 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 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 CBE must also annually provide a report to Congress and the 
Secretary under section 1890(b)(5)(A) of the Act. Section 1890(b)(5)(B) 
of the Act provides that no later than 6 months after receiving the 
annual report, the Secretary shall review such report; and publish such 
report in the Federal Register, together with any comments of the 
Secretary on such report. Although the Act requires the Secretary to 
review and publish the report, this statutory obligation does not 
constitute endorsement by the Secretary of the CBE's annual report and 
its specific recommendations.
    This Federal Register notice satisfies the requirement to 
Secretarial review and publication of the CBE's annual report under 
section 1890(b)(5)(B) of the Act. The CBE submitted a report on its 
2024 activities to Congress and the Secretary on February 24, 2025. The 
Secretary's Comments on this report are presented in section II of this 
notice, and the CBE's 2024 Activities Report to Congress and the 
Secretary is provided, as submitted to HHS, in the addendum to this 
Federal Register notice in section IV.

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II. Secretarial Comments on the CBE's (Battelle Memorial Institute) 
2024 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, it is clear that the Department of Health and Human 
Services (HHS) must continue to focus on advancing better health care 
for all Americans, strengthening public trust, and building meaningful 
engagement and learning across the health care system. By embedding the 
cross-cutting principles \1\ of advancing better health care for all 
Americans, public trust and collaboration into its diverse programs and 
initiatives, HHS is working to improve the health and well-being of 
individuals and families.
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    \1\ HHS Strategic Cross-Cutting Principles available at <a href="https://www.hhs.gov/about/strategic-plan/2022-2026/overview/index.html">https://www.hhs.gov/about/strategic-plan/2022-2026/overview/index.html</a>.
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    HHS appreciates the efforts that the CBE has made to support our 
mutual commitment to promoting a resilient, high value, and safe health 
care system for all Americans. In 2024, HHS supported the work 
conducted by the CBE to establish a measure review process that is 
reliable, transparent, attainable, objective and meaningful. This 
aligns with both Battelle and HHS' commitment to engaging all 
populations in health care quality improvement. As the CBE in 2024, 
Battelle continued to use rigorous standards to review measures for 
quality measure endorsement and maintain highly reliable and 
scientifically sound measures across priority health care topic areas.
    In 2024, the CBE continued its focus on four key initiatives: 
Endorsement & Maintenance (E&M) of clinical quality measures, Pre-
Rulemaking Measure Review (PRMR), Measure Set Review (MSR) and Core 
Quality Measures Collaborative (CQMC).
    During 2024, Battelle reviewed all measures that were submitted for 
endorsement consideration for the Fall 2023 and Spring 2024 E&M cycles. 
Battelle enhanced its focus on advancing measurement science, ensuring 
transparency and increasing the number of perspectives engaged in the 
process. This led to greater involvement from patients, advocacy 
groups, and clinicians, fostering a shared sense of ownership and 
commitment to quality improvement.
    Measures submitted for endorsement addressed critical areas like 
patient safety, clinical effectiveness, health access, and cost 
reduction. The E&M committee identified gaps in quality measurement and 
provided feedback on how the process could further evolve. In addition 
to committee feedback, Battelle also identified the need for better 
guidance in developing measure logic models, quantifying burden and 
explaining the value of a measure on the system. As the health care 
landscape evolves, Battelle remains dedicated to advancing quality and 
reducing burden through continuous improvement and innovation.
    In Fall 2023, Battelle introduced a streamlined 6-month E&M process 
that enhances consensus-building and ensures balanced participation. 
Following public and interested party feedback, the Spring 2024 cycle 
saw significant improvements to increase engagement and reduce 
committee burden. Improvements included separate meetings for Advisory 
Groups, a Public Comment Listening Session for broader input, and a 
revised voting structure emphasizing the Recommendation Group's role.
    During the 2024-2025 cycle for PRMR, the committee expanded from 
155 to 175 members while maintaining patient and clinician 
representation. To enhance measure review and public comment 
collection, PRMR meetings were shifted to the beginning of the calendar 
year. This change led to a record number of public comments, with 239 
written submissions and 51 verbal comments from 234 professional 
organizations and 56 patients/patient representatives. Listening 
sessions attracted over 458 attendees across three sessions.
    In 2024, the MSR Recommendations Group evaluated 35 measures in the 
Affordability and Efficiency domain across 10 CMS programs. Unlike the 
previous MSR cycle, which focused solely on the End-Stage Renal Disease 
Quality Improvement Program (ESRD QIP), the 2024 cycle adopted a 
holistic, cross-program review approach. This was guided by the Cascade 
of Meaningful Measures, a tool that organizes the CMS measure portfolio 
around the eight priorities of Meaningful Measures 2.0. The group 
recommended discontinuing six measures and continuing 29, following an 
open and productive discussion with CMS that provided valuable feedback 
on each measure.
    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 measurement in 
closing care gaps, 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. In October 2024, Battelle hosted the CQMC Full Annual Strategic 
Meeting to review progress and set priorities for the coming year. As 
of December 2024, the core measure sets include:
    <bullet> Accountable Care Organizations;
    <bullet> Patient-Centered Medical Homes;
    <bullet> Primary Care;
    <bullet> Behavioral Health;
    <bullet> Cardiology;
    <bullet> Gastroenterology;
    <bullet> HIV & Hepatitis C;
    <bullet> Medical Oncology;
    <bullet> Neurology;
    <bullet> Obstetrics & Gynecology;
    <bullet> Orthopedics; and
    <bullet> Pediatrics.
    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. The 
CBE is dedicated to building essential relationships within the health 
care quality community, including patients and clinicians, for 
advancing the national goal of attaining the highest level of health 
and wellness for the widest range of individuals possible.

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 2024 
Activities to Congress and the Secretary of the

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Department of Health and Human Services, as submitted to HHS.

Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
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[FR Doc. 2025-11865 Filed 6-26-25; 8:45 am]
BILLING CODE 4120-01-C


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Indexed from Federal Register on June 27, 2025.

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