Improving Diagnosis in Medicine Act of 2020

II 116TH CONGRESS 2D SESSION S. 5002 To improve the quality, appropriateness, and effectiveness of diagnosis in health care, and for other purposes. IN THE SENATE OF THE UNITED STATES DECEMBER 10, 2020 Mr. VAN HOLLEN 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Improving Diagnosis 4 in Medicine Act of 2020’’. 5 SEC. 2. RESEARCH CENTERS OF DIAGNOSTIC EXCELLENCE. 6 (a) IN GENERAL.—Section 912 of the Public Health 7 Service Act (42 U.S.C. 299b–1) is amended— 8 (1) in subsection (c), by inserting after ‘‘part 9 C’’ the following: ‘‘and subsection (d)’’; and 10 VerDate Sep 11 2014 18:14 Dec 16, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S5002.IS S5002 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 5002 IS (2) by adding at the end the following: 1 ‘‘(d) RESEARCH CENTERS OF DIAGNOSTIC EXCEL- 2 LENCE.— 3 ‘‘(1) IN GENERAL.—The Director shall award 4 grants for the establishment and maintenance of 5 centers, to be known as Research Centers of Diag- 6 nostic Excellence, that advance research and 7 progress in diagnostic quality, safety, and value in 8 clinical care and population health through imple- 9 menting the activities specified in paragraph (3). 10 ‘‘(2) CONSIDERATIONS.—In awarding grants 11 under paragraph (1), the Director shall take into 12 consideration— 13 ‘‘(A) the level of development within the 14 field of research on improving diagnosis in 15 health care; and 16 ‘‘(B) the need to plan and establish new 17 Research Centers of Diagnostic Excellence. 18 ‘‘(3) ACTIVITIES.— 19 ‘‘(A) REQUIRED ACTIVITIES.—Each Re- 20 search Center of Diagnostic Excellence receiv- 21 ing funds pursuant to paragraph (1) shall use 22 such funds to— 23 VerDate Sep 11 2014 18:14 Dec 16, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S5002.IS S5002 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 5002 IS ‘‘(i) serve as an interdisciplinary core 1 diagnostic research hub for conducting di- 2 agnostic safety and quality research; 3 ‘‘(ii) support research and public 4 health initiatives on improving diagnosis in 5 medicine; and 6 ‘‘(iii) foster high-impact research on 7 novel solutions to improve diagnosis that 8 will significantly reduce patient harm. 9 ‘‘(B) PERMISSIBLE ACTIVITIES.—In addi- 10 tion to the required activities listed in subpara- 11 graph (A), each Research Center of Diagnostic 12 Excellence receiving funds pursuant to para- 13 graph (1) may use such funds to— 14 ‘‘(i) build capacity by cultivating, 15 training, and developing a highly qualified 16 diagnostic research workforce; 17 ‘‘(ii) develop and validate operation- 18 ally viable measures of diagnostic error to 19 assess which approaches are effective for 20 monitoring the diagnosis process of identi- 21 fying, analyzing, and reducing diagnostic 22 errors; and 23 ‘‘(iii) utilize strategic partnerships 24 that capitalize on the capabilities of both 25 VerDate Sep 11 2014 18:14 Dec 16, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S5002.IS S5002 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 5002 IS academic research institutions and non- 1 academic health care, public health, 2 science, and technology stakeholders.’’. 3 SEC. 3. INTERAGENCY COUNCIL ON IMPROVING DIAGNOSIS 4 IN HEALTH CARE. 5 (a) ESTABLISHMENT.—The Secretary of Health and 6 Human Services (in this section referred to as the ‘‘Sec- 7 retary’’) shall establish within the Office of the Secretary 8 an interagency council to be known as the Interagency 9 Council on Improving Diagnosis in Health Care (in this 10 section referred to as the ‘‘Council’’). 11 (b) OBJECTIVES.—The objectives of the Council shall 12 be the following: 13 (1) Enhance the quality, appropriateness, and 14 effectiveness of diagnosis in health care through— 15 (A) the establishment and support of a 16 broad base of scientific research; 17 (B) the dissemination and implementation 18 of the results of such research; and 19 (C) the promotion of improvements in clin- 20 ical and health system practices. 21 (2) Identify and eliminate systemic barriers to 22 supporting research in improving diagnosis in health 23 care. 24 VerDate Sep 11 2014 18:14 Dec 16, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S5002.IS S5002 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 5002 IS (3) Identify knowledge gaps, research needs, 1 and deficiencies in clinical and health system deliv- 2 ery, associated with the diagnostic process, with an 3 emphasis on clarifying needs across the diagnostic 4 research continuum. 5 (4) Create core diagnostic research services and 6 interdisciplinary teams to facilitate diagnostic re- 7 search. 8 (5) Build capacity by training and developing a 9 highly qualified diagnostic research workforce. 10 (6) Establish valid operational measures of di- 11 agnostic error. 12 (c) MEMBERSHIP.— 13 (1) CHAIRPERSON.—The Director of the Agen- 14 cy for Healthcare Research and Quality (or the Di- 15 rector’s designee) shall be the Chairperson of the 16 Council. 17 (2) MEMBERS.— 18 (A) IN GENERAL.—In addition to the 19 Chairperson, the Council shall be comprised of 20 the following: 21 (i) At least 1 designee from each of 22 the following, appointed by the head of the 23 applicable department or agency: 24 VerDate Sep 11 2014 04:17 Dec 20, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S5002.IS S5002 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 5002 IS (I) The Centers for Disease Con- 1 trol and Prevention. 2 (II) The Centers for Medicare & 3 Medicaid Services. 4 (III) The Department of Vet- 5 erans Affairs. 6 (IV) The Congressionally Di- 7 rected Medical Research Program of 8 the Department of Defense. 9 (ii) Designees from the National Insti- 10 tutes of Health, including a least 1 des- 11 ignee from each of the following: 12 (I) The National Cancer Insti- 13 tute. 14 (II) The National Center for Ad- 15 vancing Translational Sciences. 16 (III) The National Institute of 17 Allergy and Infectious Diseases. 18 (IV) The National Heart, Lung, 19 and Blood Institute. 20 (V) The National Institute of 21 Neurological Disorders and Stroke. 22 (VI) The National Library of 23 Medicine. 24 VerDate Sep 11 2014 18:14 Dec 16, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S5002.IS S5002 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 5002 IS (iii) Designees from such other na- 1 tional research institutes and national cen- 2 ters as may be appropriate, as determined 3 by the Director of the National Institutes 4 of Health. 5 (B) ADDITIONAL MEMBERS.—In addition 6 to the designees under subparagraph (A), the 7 Council may include such other designees from 8 Federal departments or agencies as the Chair- 9 person of the Council deems appropriate. 10 (C) DESIGNATION.—A person appointed to 11 the Council as a designee shall be a senior offi- 12 cial or employee of the department or agency 13 whose responsibilities and subject matter exper- 14 tise are relevant to the Council’s objectives list- 15 ed in subsection (b), as determined by the des- 16 ignating official. 17 (d) STRATEGIC PLAN; REPORTS.— 18 (1) STRATEGIC FEDERAL PLAN TO IMPROVE DI- 19 AGNOSIS IN HEALTH CARE.—Not later than 18 20 months after the date of enactment of this Act, the 21 Council shall develop, submit to the Secretary and 22 Congress, and make publicly available a strategic 23 plan, to be known as the Strategic Federal Plan to 24 VerDate Sep 11 2014 18:14 Dec 16, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S5002.IS S5002 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 5002 IS Improve Diagnosis, that, consistent with the objec- 1 tives listed in subsection (b)— 2 (A) identifies coordinated opportunities to 3 enhance scientific research and reduce systemic 4 barriers in order to improve diagnosis in health 5 care; and 6 (B) includes legislative and administrative 7 policy recommendations. 8 (2) REPORTS TO CONGRESS.—Not later than 9 July 31 of every odd-numbered year beginning with 10 the first such year after the date of submission of 11 the first Strategic Federal Plan to Improve Diag- 12 nosis under paragraph (1), the Council shall pre- 13 pare, submit to the Secretary and Congress, and 14 make publicly available an updated Strategic Fed- 15 eral Plan to Improve Diagnosis that includes— 16 (A) such updates as the Council deter- 17 mines to be appropriate; 18 (B) information on the overall progress of 19 the Federal Government in reducing barriers to 20 research on, and supporting projects to im- 21 prove, diagnosis in health care; and 22 (C) legislative and administrative policy 23 recommendations, including addressing any 24 VerDate Sep 11 2014 18:14 Dec 16, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S5002.IS S5002 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 5002 IS needs for greater legislative authority to meet 1 the objectives listed in subsection (b). 2 SEC. 4. AUTHORIZATION OF APPROPRIATIONS. 3 There is authorized to be appropriated to carry out 4 this Act (including the amendments made by this Act) 5 $8,000,000 for each of fiscal years 2021 through 2025, 6 to remain available until expended. 7 Æ VerDate Sep 11 2014 18:14 Dec 16, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\S5002.IS S5002 pamtmann on DSKBC07HB2PROD with BILLS