[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5613 Introduced in Senate (IS)]
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118th CONGRESS
2d Session
S. 5613
To improve the quality, appropriateness, and effectiveness of diagnosis
in health care, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 19 (legislative day, December 16), 2024
Mr. Van Hollen (for himself and Mr. Lujan) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To improve the quality, appropriateness, and effectiveness of diagnosis
in health care, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Improving Diagnosis in Medicine Act
of 2022''.
SEC. 2. RESEARCH PROGRAM TO IMPROVE DIAGNOSTIC SAFETY AND QUALITY.
Part B of title IX of the Public Health Service Act (42 U.S.C. 299b
et seq.) is amended by adding at the end the following:
``SEC. 918. RESEARCH PROGRAM TO IMPROVE DIAGNOSTIC SAFETY AND QUALITY.
``(a) In General.--The Director shall establish a comprehensive
program of research and quality improvement to--
``(1) assess and understand diagnostic errors, including
diagnostic delays, and how to eliminate common failures in the
diagnostic process that lead to significant patient harm; and
``(2) identify, develop, implement, and disseminate
evidence-based strategies and best practices for improving
diagnostic quality, safety, and health care value.
``(b) Activities.--The program established under subsection (a)
shall include the following:
``(1) Continuum of research.--A portfolio of conducted and
supported activities that is consistent with the general,
research, implementation, and dissemination activities of the
Center for Quality Improvement and Patient Safety, as described
in section 933, including--
``(A) investigator-initiated research to assess
diagnostic errors and identify improved methods to
prevent errors and the harm they cause;
``(B) translation and synthesis of research
findings and development of tools for implementing
prevention strategies into practice;
``(C) implementation research to refine evidence-
based tools for improving diagnostic processes and
effectively integrate these solutions into practice;
and
``(D) dissemination to promote implementation of
effective methods, strategies and tools for wide-scale
improvement.
``(2) Research centers of diagnostic excellence.--
Consistent with section 911(b), such Centers shall link
research directly with clinical practice in geographically
diverse locations throughout the United States, and may
include--
``(A) academic medical and institutional research
centers that combine demonstrated multidisciplinary
expertise in diagnostic outcomes or quality improvement
research with linkages directly or through national,
state or local stakeholder partner organizations to
relevant sites of care;
``(B) provider-based research networks, including
plan, facility, or delivery system sites of care
(especially primary care), that can evaluate outcomes
and evaluate and promote quality improvement
approaches.
``(3) Financial assistance.--The Director may provide
financial assistance to assist in meeting the costs of planning
and establishing new centers, as well as operating existing and
new centers, pursuant to section 902(c).
``(4) Stakeholder engagement.--The Director shall identify
and enter into a supporting agreement (grant or contract) with
a nonprofit entity that convenes a coalition of diverse health
care stakeholders for the purpose of--
``(A) raising attention to diagnostic safety and
quality concerns;
``(B) facilitating learning, adoption and spread of
effective quality improvement interventions; and
``(C) catalyzing novel actions by individual member
organizations to reduce harms from diagnostic error and
improve patient outcomes.
``(c) Authorization of Appropriations.--
``(1) In general.--To carry out this section, there is
authorized to be appropriated $20,000,000 for fiscal year 2023,
$25,000,000 for fiscal year 2024, $30,000,000 for fiscal year
2025, and $35,000,000 for each of fiscal years 2026 and 2027.
``(2) Reservation.--Of the amount appropriated under
paragraph (1) for a fiscal year, $700,000 shall be allocated to
carrying out the purpose described in subsection (b)(4).
``(3) Availability.--Amounts appropriated under this
section shall remain available until expended.''.
SEC. 3. FELLOWSHIPS AND TRAINING GRANTS.
(a) Ruth Kirschstein Awards.--Section 487(a) of the Public Health
Service Act (42 U.S.C. 288(a)) is amended by adding at the end the
following:
``(5) For purposes of the program under this subsection, biomedical
and behavioral research includes diagnostic safety and quality
research.''.
(b) AHRQ Programs.--Section 902(b)(1) of the Public Health Service
Act (42 U.S.C. 299a(b)(1)) is amended--
(1) by inserting ``and diagnostic safety and quality''
after ``subsection (a)''; and
(2) by striking ``under section 487(d)(3)'' and inserting
``for purposes of carrying out section 487''.
SEC. 4. QUALITY MEASURE DEVELOPMENT.
Section 931(c)(2) of the Public Health Service Act (42 U.S.C. 299b-
31(c)(2)) is amended--
(1) by redesignating subparagraphs (B) through (J) as
subparagraphs (C) through (K), respectively; and
(2) by inserting after subparagraph (A) the following:
``(B) diagnostic safety and quality;''.
SEC. 5. DATA FOR RESEARCH AND IMPROVEMENT.
Section 937(f) of the Public Health Service Act (42 U.S.C. 299b-
37(f)) is amended--
(1) by striking ``The Secretary'' and inserting the
following:
``(1) In general.--The Secretary''; and
(2) adding at the end the following:
``(2) Consultation with expert panel.--In carrying out
paragraph (1), the Secretary, in coordination with the
Director, the Director of the Centers for Medicare & Medicaid
Services, the National Coordinator for Health Information
Technology, and the National Library of Medicine, shall convene
an expert panel to consider and make recommendations regarding
the types, sources, and availability of data needed to
accelerate diagnostic safety and quality research, training,
and measure development as specified in section 918, including
data related to racial, ethnic, and language attributes;
gender, age, geography, and socioeconomic conditions; the
specificity, interoperability, and socio-technical aspects of
electronic vocabularies and ontologies related to presenting
symptoms and diagnostic certainty; and the development and use
of symptom-based clinical registries. Such panel shall consider
enhanced data capabilities that are necessary to support both
research and improvement of diagnostic safety and quality.''.
SEC. 6. INTERAGENCY COUNCIL ON IMPROVING DIAGNOSIS IN HEALTH CARE.
(a) Establishment.--The Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall establish within
the Office of the Secretary an interagency council to be known as the
Interagency Council on Improving Diagnosis in Health Care (referred to
in this section as the ``Council'').
(b) Objectives.--The objectives of the Council shall be the
following:
(1) Enhance the quality, appropriateness, and effectiveness
of diagnosis in health care through--
(A) the establishment and support of a broad base
of scientific research;
(B) the dissemination and implementation of the
results of such research; and
(C) the promotion of improvements in clinical and
health system practices.
(2) Identify and eliminate systemic barriers to supporting
research in improving diagnosis in health care.
(3) Identify knowledge gaps, research and data needs, and
opportunities congruent with agency missions to strengthen the
clinical and translational research pipeline to improve
diagnostic safety and quality, including potential
collaborative research initiatives among 2 or more agencies,
offices, institutes, or centers within the Department of Health
and Human Services or other Federal agencies or offices.
(c) Membership.--
(1) Chairperson.--The Director of the Agency for Healthcare
Research and Quality (or the Director's designee) shall be the
Chairperson of the Council.
(2) Members.--
(A) In general.--In addition to the Chairperson,
the Council shall be comprised of the following:
(i) At least 1 designee from each of the
following, appointed by the head of the
applicable department or agency:
(I) The Centers for Disease Control
and Prevention.
(II) The Centers for Medicare &
Medicaid Services.
(III) The Department of Veterans
Affairs.
(IV) The Congressionally Directed
Medical Research Program of the
Department of Defense.
(V) The Office of the National
Coordinator for Health Information
Technology.
(ii) Designees from the National Institutes
of Health, including a least 1 designee from
each of the following:
(I) The National Cancer Institute.
(II) The National Center for
Advancing Translational Sciences.
(III) The National Institute of
Allergy and Infectious Diseases.
(IV) The National Heart, Lung, and
Blood Institute.
(V) The National Institute of
Neurological Disorders and Stroke.
(VI) The National Library of
Medicine.
(VII) The National Institute on
Minority Health and Health Disparities.
(VIII) The National Institute of
Nursing Research.
(IX) The Eunice Kennedy Shriver
National Institute of Child Health and
Human Development.
(iii) Designees from such other national
research institutes and national centers as may
be appropriate, as determined by the Director
of the National Institutes of Health.
(B) Additional members.--In addition to the
designees under subparagraph (A), the Council may
include such other designees from Federal departments
or agencies as the Chairperson of the Council deems
appropriate.
(C) Designation.--A person appointed to the Council
as a designee shall be a senior official or employee of
the department or agency whose responsibilities and
subject matter expertise are relevant to the Council's
objectives listed in subsection (b), as determined by
the designating official.
(d) Strategic Plan; Reports.--
(1) Strategic federal plan to improve diagnosis in health
care.--Not later than 18 months after the date of enactment of
this Act, the Council shall develop, submit to the Secretary
and Congress, and make publicly available a strategic plan, to
be known as the Strategic Federal Plan to Improve Diagnosis,
that, consistent with the objectives listed in subsection (b)--
(A) identifies coordinated opportunities to enhance
scientific research and reduce systemic barriers in
order to improve diagnosis in health care; and
(B) includes legislative and administrative policy
recommendations, including opportunities to remove
barriers to, and enhance, inter-agency coordination in
the planning, conduct, and funding of, such research.
(2) Reports to congress.--Not later than July 31 of every
odd-numbered year beginning with the first such year after the
date of submission of the first Strategic Federal Plan to
Improve Diagnosis under paragraph (1), the Council shall
prepare, submit to the Secretary and Congress, and make
publicly available an updated Strategic Federal Plan to Improve
Diagnosis that includes--
(A) such updates as the Council determines to be
appropriate;
(B) information on the overall progress of the
Federal Government in reducing barriers to research on,
and supporting projects to improve, diagnosis in health
care; and
(C) legislative and administrative policy
recommendations, including addressing any needs for
greater legislative authority to meet the objectives
listed in subsection (b).
(e) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $1,500,000 for each of fiscal
years 2023 through 2027.
SEC. 7. NATIONAL ACADEMIES REPORT.
(a) In General.--The Director of the Agency for Healthcare Research
and Quality shall seek to enter into a contract with the National
Academies of Sciences, Engineering, and Medicine under which such
National Academies conducts a study and issues a report on disparities
in diagnostic safety and quality that--
(1) identifies what is known about the burden and causes of
such disparities, including racial, ethnic, socioeconomic, age,
gender, geography, language proficiency, and intersectional
interactions; and
(2) includes recommendations on specific actions that
policymakers, researchers, clinicians, and other stakeholders
can take to eliminate such burdens.
(b) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $1,500,000 for fiscal year 2023,
to remain available until expended.
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