90 FR 122 pgs. 27542-27613 - 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

Type: NOTICEVolume: 90Number: 122Pages: 27542 - 27613
Docket number: [CMS-3467-N]
FR document: [FR Doc. 2025-11865 Filed 6-26-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Medicare & Medicaid Services
Official PDF Version:  PDF Version
Pages: 27542, 27543, 27544, 27545, 27546, 27547, 27548, 27549, 27550, 27551, 27552, 27553, 27554, 27555, 27556, 27557, 27558, 27559, 27560, 27561, 27562, 27563, 27564, 27565, 27566, 27567, 27568, 27569, 27570, 27571, 27572, 27573, 27574, 27575, 27576, 27577, 27578, 27579, 27580, 27581, 27582, 27583, 27584, 27585, 27586, 27587, 27588, 27589, 27590, 27591, 27592, 27593, 27594, 27595, 27596, 27597, 27598, 27599, 27600, 27601, 27602, 27603, 27604, 27605, 27606, 27607, 27608, 27609, 27610, 27611, 27612, 27613

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid 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.

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


[top] 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:

• 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 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.


[top] 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. page 27544

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.

Footnotes:

1 ?HHS Strategic Cross-Cutting Principles available at https://www.hhs.gov/about/strategic-plan/2022-2026/overview/index.html.

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:

• Accountable Care Organizations;

• Patient-Centered Medical Homes;

• Primary Care;

• Behavioral Health;

• Cardiology;

• Gastroenterology;

• HIV & Hepatitis C;

• Medical Oncology;

• Neurology;

• Obstetrics & Gynecology;

• Orthopedics; and

• 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


[top] In this Addendum, we are publishing the CBE Report on 2024 Activities to Congress and the Secretary of the page 27545 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]

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