[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4468 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4468

To improve the quality, appropriateness, and effectiveness of diagnosis 
                in health care, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 23, 2022

  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; and
                    ``(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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