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.

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.

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 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 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.

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 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.

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[FR Doc. 2024-19479 Filed 8-28-24; 4:15 pm]

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