2019-13626. Secretarial Review and Publication of the National Quality Forum 2018 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) receipt and review of the National Quality Forum 2018 Annual Activities Report to Congress and the Secretary submitted by the consensus-based entity under contract with the Secretary in accordance with the Social Security Act. The Secretary has reviewed 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 Social Security Act.

FOR FURTHER INFORMATION CONTACT:

Sophia Chan, [phone].

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 measurements 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 to contract with the consensus-based entity (CBE) to perform multiple duties designed 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.

HHS awarded a competitive contract to the National Quality Forum (NQF) in January 2009 to fulfill the requirements of section 1890 of the Act. A second, multi-year contract was awarded to NQF after an open competition in 2012. A third, multi-year 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 is to 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 across multiple providers, practitioners and 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.

Review and Endorsement of an Episode Grouper Under the Physician Feedback Program: The CBE must provide for the review and, as appropriate, the endorsement of the episode grouper developed by the Secretary on an expedited basis.

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; (2) 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 (3) 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, 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 must 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 report to include the following each year: (1) An itemization of financial information for the previous fiscal year, 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 as they relate to 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 of HHS 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 complies with the statutory requirement for Secretarial review and publication of the CBE's annual report. NQF submitted a report on its 2018 activities to the Secretary on March 1, 2019. Comments from the Secretary on the report are presented in section II of this notice, and the National Quality Forum 2018 Activities Report to Congress and the Secretary of the Department of Health and Human Services 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 2018 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. As part of its annual recurring work to maintain a strong portfolio of endorsed measures for use across varied providers, settings of care, and health conditions, NQF reports that in 2018 it updated its measure portfolio by reviewing and endorsing or re-endorsing 38 measures and removing 40 measures.^[1] Endorsed measures address a wide range of health care topics to promote value-based transformation of our health care system, and other HHS priorities, 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 also worked to remove measures from the portfolio for a variety of reasons, such as, measures no longer meeting endorsement criteria; 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.^[2] 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 HHS initiatives, such as the Meaningful Measures Initiative at Centers for Medicare and Medicaid Services (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.

NQF also undertook and continued a number of targeted projects dealing with difficult quality measurement issues. In particular, NQF has worked to help HHS address the unique challenges faced by rural communities. Nearly one in five Americans reside in rural communities and statistically, residents of rural communities tend to have worse health status than those living in urban areas.^[3] HHS recognizes the unique challenges facing rural America, and with the support of partners like NQF, we are taking action to improve access and quality for healthcare providers serving rural patients. One of the biggest challenges rural Americans face is access to affordable quality health care.^[4 5 6] Our reforms in the area of rural health are part of our overall strategy to update our programs and improve access to high quality services.

In 2018, recognizing the lack of representation from rural stakeholders in the pre-rulemaking process, HHS tasked NQF to establish a Measures Application Partnership (MAP) Rural Health Workgroup. The membership of the Workgroup, comprised of 18 organizational members, seven subject matter experts, and 3 federal liaisons, reflects the diversity of rural providers and residents, and allows for input from those most affected and most knowledgeable about rural measurement challenges and potential solutions.^[7] With this valuable input from our partners and stakeholders, HHS can continue to improve health care in rural America.

The Workgroup identified a core set of the best available, “rural-relevant” measures to address the needs of the rural population and released a report providing recommendations regarding alignment and coordination of measurement efforts across both public and private programs, care settings, specialties, and sectors (both public and private).^[8] NQF presented the Workgroup's finding on Capitol Hill to share this valuable work with members of the Congress.^[9] The Workgroup also provided guidance for the Measures Application Partnership to ensure that the Measures Under Consideration (MUC) for use in CMS programs address the needs and challenges of rural providers and residents.^[10] HHS is committed to evaluating our measurement practices and looking at them through a rural lens to ensure rural providers greater flexibility and less regulatory burden.

Additionally, CMS and NQF have worked together to address the low case-volume challenge as it pertains to healthcare performance measurement of rural providers. Low case-volume presents a significant measurement challenge for many rural providers.^[11] Rural areas often are sparsely populated, which can affect the number of patients eligible for inclusion in healthcare performance measures, particularly condition- or procedure-specific measures. Other challenges faced by rural residents, such as distance to care or lack of transportation, can also lead to low case-volume in measurement. To develop recommendations to address the low case-volume challenge for rural providers, NQF convened a five-member Technical Expert Panel (TEP) comprised of statistical experts and measure methodologists.^[12] The TEP released a report providing recommendations to CMS on how to best address the low case-volume challenge by incorporating new statistical methods into measures specifications.^[13]

Going forward, CMS will continue to work with NQF to strengthen the diversity of representation of the MAP Rural Health Workgroup. In particular, CMS is taking into account the largely rural nature of Tribal and Indian Health Service (IHS) health programs, their unique, cultural, funding, and legal status, and their specific challenges in participating in initiatives, which rely heavily on the use of clinical quality measures. For future NQF calls for nomination for the MAP Rural Health Workgroup, CMS will encourage NQF to sit representatives of Tribal Nations, Tribal health programs, or Tribal organizations. CMS will also reach out to IHS for recommendations of individuals with expertise in clinical quality measures and knowledge in health outcomes and barriers to care experienced by rural-dwelling Native Americans and nominate them as Workgroup members, and IHS staff with said expertise and experience as Federal Liaisons for the Workgroup. In addition, CMS will ask NQF to reach out to Tribal Nations, Tribal Health programs, and Tribal organizations for input during the public comment periods for project deliverables.

Addressing the needs of rural health communities is just one of many areas in which NQF partners with HHS in enhancing and protecting the health and well-being of all Americans. Meaningful quality measurement is essential to healthcare delivery reform, 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 help develop the strongest possible approaches to quality measurement as a key component to health care delivery system reform. We appreciate the 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.).

IV. Addendum

In this Addendum, we are publishing the NQF Report on 2018 Activities to Congress and the Secretary of the Department of Health and Human Services, as submitted to HHS.

Dated: June 7, 2019.

Alex M. Azar II,

Secretary, Department of Health and Human Services.

Footnotes

1.  National Quality Forum (March 1, 2019) Report of 2018 Activities to Congress and the Secretary of the Department of Health and Human Services, p. 6 (https://www.qualityforum.org/​Publications/​2019/​03/​2018_​Annual_​Report_​for_​Congress.aspx,, accessed 4/10/2019).

2.  National Quality Forum, op. cit. p. 18.

3.  Centers for Disease Control and Prevention (January 2017) Rural Americans at higher risk of death from five leading causes. (https://www.cdc.gov/​media/​releases/​2017/​p0112-rural-death-risk.html,, accessed 4/10/2019).

4.  Douthit, N., S. Kiv, T. Dwolatzky, and S. Biswas (June 2015). Exposing some important barriers to health care access in the rural USA. Public Health. 129(6): 611-620.

5.  D. Williams, Jr., and M. Holmes (January 2018) Rural Health Care Costs: Are They Higher and Why Might They Differ from Urban Health Care Cost? North Carolina Medical Journal. 79(1): 51-55.

6.  J. Bhatt and P. Bathija (September 2018) Ensuring Access to Quality Health Care in Vulnerable Communities. Academic Medicine. 93(9): 1271-1275.

7.  National Quality Forum (August 31, 2018). A Core Set of Rural-Relevant Measures and Measuring the Improving Access to Care: 2018 Recommendations from the MAP Rural Health Workgroup: Final Report, p. 32 (https://www.qualityforum.org/​Publications/​2018/​08/​MAP_​Rural_​Health_​Final_​Report_​-_​2018.aspx,, accessed 4/10/2019).

8.  National Quality Forum. 2018, op. cit.

9.  National Quality Forum (September 17, 2018) NQF Releases Report to Improve Access and Health Needs of Rural Communities (http://www.qualityforum.org/​News_​And_​Resources/​Press_​Releases/​2018/​NQF_​Releases_​Report_​to_​Improve_​Access_​and_​Health_​Needs_​of_​Rural_​Communities.aspx,, accessed 4/10/2018).

10.  National Quality Forum (December 12, 2018). MAP Clinician Workgroup In-Person Meeting presentation slides #38-43. (http://www.qualityforum.org/​ProjectMaterials.aspx?​projectID=​75361,, accessed 4/10/2019).

11.  Quality of Care in Rural Hospitals. (January 2019) Rural Health Research RECAP. Rural Health Research Gateway (https://ruralhealth.und.edu/​assets/​2645-9942/​quality-of-care-in-rural-hospitals-recap.pdf,, accessed 4/10/2019).

12.  National Quality Forum. (October 31, 2018) MAP Rural Health Technical Expert Panel Conference Call #1 presentation slides (http://www.qualityforum.org/​ProjectMaterials.aspx?​projectID=​85919,, accessed 4/10/2019).

13.  National Quality Forum (April 2019). MAP Rural Health Technical Expert Panel Final Report—2019 (http://www.qualityforum.org/​Publications/​2019/​04/​MAP_​Rural_​Health_​Technical_​Expert_​Panel_​Final_​Report_​-_​2019.aspx,, accessed 4/10/2019).