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###### Department of Health and Human Services

          - [CMS-3402-N]

# AGENCY:

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

# ACTION:

Notice.

# **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,                               ( print page 48155)                            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:                    
      - 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 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;                               ( print page 48156)                            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.[1 2]                          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.                    

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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# Footnotes

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).                        
        Back to Citation      

BILLING CODE 4150-28-P

[FR Doc. 2021-18485 Filed 8-26-21; 8:45 am]

BILLING CODE 4150-28-C