[Federal Register Volume 84, Number 123 (Wednesday, June 26, 2019)]
[Notices]
[Pages 30129-30209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13626]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[CMS-3365-N]


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.

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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, (410) 786-5050.

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

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

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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.
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    \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).
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    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\
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    \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).
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    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.
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[FR Doc. 2019-13626 Filed 6-25-19; 8:45 am]
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