I 116th CONGRESS 1st Session H. R. 5014 IN THE HOUSE OF REPRESENTATIVES November 8, 2019 Mr. Luján (for himself and Mr. Bilirakis ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To improve the quality, appropriateness, and effectiveness of diagnosis in health care, and for other purposes.

1. Short title This Act may be cited as the Improving Diagnosis in Medicine Act of 2019 . 2. Research centers of diagnostic excellence (a) In general Section 912 of the Public Health Service Act ( 42 U.S.C. 299b–1 ) is amended— (1) in subsection (c), by inserting after part C the following: and subsection (d) ; and (2) by adding at the end the following: (d) Research Centers of Diagnostic Excellence (1) In general The Director shall award grants for the establishment and maintenance of centers, to be known as Research Centers of Diagnostic Excellence, that advance research and progress in diagnostic quality, safety, and value in clinical care and population health through implementing the activities specified in paragraph (3). (2) Considerations In awarding grants under paragraph (1), the Director shall take into consideration— (A) the level of development within the field of research on improving diagnosis in health care; and (B) the need to plan and establish new Research Centers of Diagnostic Excellence. (3) Activities (A) Required activities Each Research Center of Diagnostic Excellence receiving funds pursuant to paragraph (1) shall use such funds to— (i) serve as an interdisciplinary core diagnostic research hub for conducting diagnostic safety and quality research; (ii) support research and public health initiatives on improving diagnosis in medicine; and (iii) foster high-impact research on novel solutions to improve diagnosis that will significantly reduce patient harm. (B) Permissible activities In addition to the required activities listed in subparagraph (A), each Research Center of Diagnostic Excellence receiving funds pursuant to paragraph (1) may use such funds to— (i) build capacity by cultivating, training, and developing a highly qualified diagnostic research workforce; (ii) develop and validate operationally viable measures of diagnostic error to assess which approaches are effective for monitoring the diagnosis process of identifying, analyzing, and reducing diagnostic errors; and (iii) utilize strategic partnerships that capitalize on the capabilities of both academic research institutions and non-academic health care, public health, science, and technology stakeholders. . 3. 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 (in this section referred to 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 needs, and deficiencies in clinical and health system delivery, associated with the diagnostic process, with an emphasis on clarifying needs across the diagnostic research continuum. (4) Create core diagnostic research services and interdisciplinary teams to facilitate diagnostic research. (5) Build capacity by training and developing a highly-qualified diagnostic research workforce. (6) Establish valid operational measures of diagnostic error. (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 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 National Institutes of Health, including designees from— (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; and (VII) 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. (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). 4. Authorization of appropriations There is authorized to be appropriated to carry out this Act (including the amendments made by this Act) $8,000,000 for each of fiscal years 2021 through 2025, to remain available until expended.