[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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