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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Improving Diagnosis 

5 in Medicine Act of 2020’’. 

6 SEC. 2. RESEARCH CENTERS OF DIAGNOSTIC EXCELLENCE. 

7 (a) IN GENERAL.—Section 912 of the Public Health 

8 Service Act (42 U.S.C. 299b–1) is amended— 

9 (1) in subsection (c), by inserting after ‘‘part 

10 C’’ the following: ‘‘and subsection (d)’’; and 


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1 (2) by adding at the end the following: 

2 ‘‘(d) RESEARCH CENTERS OF DIAGNOSTIC EXCEL3 LENCE.— 

4 ‘‘(1) IN GENERAL.—The Director shall award 

5 grants for the establishment and maintenance of 

6 centers, to be known as Research Centers of Diag7 nostic Excellence, that advance research and 

8 progress in diagnostic quality, safety, and value in 

9 clinical care and population health through imple10 menting the activities specified in paragraph (3). 

11 ‘‘(2) CONSIDERATIONS.—In awarding grants 

12 under paragraph (1), the Director shall take into 

13 consideration— 

14 ‘‘(A) the level of development within the 

15 field of research on improving diagnosis in 

16 health care; and 

17 ‘‘(B) the need to plan and establish new 

18 Research Centers of Diagnostic Excellence. 

19 ‘‘(3) ACTIVITIES.— 

20 ‘‘(A) REQUIRED ACTIVITIES.—Each Re21 search Center of Diagnostic Excellence receiv22 ing funds pursuant to paragraph (1) shall use 

23 such funds to— 


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1 ‘‘(i) serve as an interdisciplinary core 

2 diagnostic research hub for conducting di3 agnostic safety and quality research; 

4 ‘‘(ii) support research and public 

5 health initiatives on improving diagnosis in 

6 medicine; and 

7 ‘‘(iii) foster high-impact research on 

8 novel solutions to improve diagnosis that 

9 will significantly reduce patient harm. 

10 ‘‘(B) PERMISSIBLE ACTIVITIES.—In addi11 tion to the required activities listed in subpara12 graph (A), each Research Center of Diagnostic 

13 Excellence receiving funds pursuant to para14 graph (1) may use such funds to— 

15 ‘‘(i) build capacity by cultivating, 

16 training, and developing a highly qualified 

17 diagnostic research workforce; 

18 ‘‘(ii) develop and validate operation19 ally viable measures of diagnostic error to 

20 assess which approaches are effective for 

21 monitoring the diagnosis process of identi22 fying, analyzing, and reducing diagnostic 

23 errors; and 

24 ‘‘(iii) utilize strategic partnerships 

25 that capitalize on the capabilities of both 


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1 academic research institutions and non2 academic health care, public health, 

3 science, and technology stakeholders.’’. 

4 SEC. 3. INTERAGENCY COUNCIL ON IMPROVING DIAGNOSIS 

5 IN HEALTH CARE. 

6 (a) ESTABLISHMENT.—The Secretary of Health and 

7 Human Services (in this section referred to as the ‘‘Sec8 retary’’) shall establish within the Office of the Secretary 

9 an interagency council to be known as the Interagency 

10 Council on Improving Diagnosis in Health Care (in this 

11 section referred to as the ‘‘Council’’). 

12 (b) OBJECTIVES.—The objectives of the Council shall 

13 be the following: 

14 (1) Enhance the quality, appropriateness, and 

15 effectiveness of diagnosis in health care through— 

16 (A) the establishment and support of a 

17 broad base of scientific research; 

18 (B) the dissemination and implementation 

19 of the results of such research; and 

20 (C) the promotion of improvements in clin21 ical and health system practices. 

22 (2) Identify and eliminate systemic barriers to 

23 supporting research in improving diagnosis in health 

24 care. 


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1 (3) Identify knowledge gaps, research needs, 

2 and deficiencies in clinical and health system deliv3 ery, associated with the diagnostic process, with an 

4 emphasis on clarifying needs across the diagnostic 

5 research continuum. 

6 (4) Create core diagnostic research services and 

7 interdisciplinary teams to facilitate diagnostic re8 search. 

9 (5) Build capacity by training and developing a 

10 highly qualified diagnostic research workforce. 

11 (6) Establish valid operational measures of di12 agnostic error. 

13 (c) MEMBERSHIP.— 

14 (1) CHAIRPERSON.—The Director of the Agen15 cy for Healthcare Research and Quality (or the Di16 rector’s designee) shall be the Chairperson of the 

17 Council. 

18 (2) MEMBERS.— 

19 (A) IN GENERAL.—In addition to the 

20 Chairperson, the Council shall be comprised of 

21 the following: 

22 (i) At least 1 designee from each of 

23 the following, appointed by the head of the 

24 applicable department or agency: 


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1 (I) The Centers for Disease Con2 trol and Prevention. 

3 (II) The Centers for Medicare & 

4 Medicaid Services. 

5 (III) The Department of Vet6 erans Affairs. 

7 (IV) The Congressionally Di8 rected Medical Research Program of 

9 the Department of Defense. 

10 (ii) Designees from the National Insti11 tutes of Health, including a least 1 des12 ignee from each of the following: 

13 (I) The National Cancer Insti14 tute. 

15 (II) The National Center for Ad16 vancing Translational Sciences. 

17 (III) The National Institute of 

18 Allergy and Infectious Diseases. 

19 (IV) The National Heart, Lung, 

20 and Blood Institute. 

21 (V) The National Institute of 

22 Neurological Disorders and Stroke. 

23 (VI) The National Library of 

24 Medicine. 


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1 (iii) Designees from such other na2 tional research institutes and national cen3 ters as may be appropriate, as determined 

4 by the Director of the National Institutes 

5 of Health. 

6 (B) ADDITIONAL MEMBERS.—In addition 

7 to the designees under subparagraph (A), the 

8 Council may include such other designees from 

9 Federal departments or agencies as the Chair10 person of the Council deems appropriate. 

11 (C) DESIGNATION.—A person appointed to 

12 the Council as a designee shall be a senior offi13 cial or employee of the department or agency 

14 whose responsibilities and subject matter exper15 tise are relevant to the Council’s objectives list16 ed in subsection (b), as determined by the des17 ignating official. 

18 (d) STRATEGIC PLAN; REPORTS.— 

19 (1) STRATEGIC FEDERAL PLAN TO IMPROVE DI20 AGNOSIS IN HEALTH CARE.—Not later than 18 

21 months after the date of enactment of this Act, the 

22 Council shall develop, submit to the Secretary and 

23 Congress, and make publicly available a strategic 

24 plan, to be known as the Strategic Federal Plan to 


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1 Improve Diagnosis, that, consistent with the objec2 tives listed in subsection (b)— 

3 (A) identifies coordinated opportunities to 

4 enhance scientific research and reduce systemic 

5 barriers in order to improve diagnosis in health 

6 care; and 

7 (B) includes legislative and administrative 

8 policy recommendations. 

9 (2) REPORTS TO CONGRESS.—Not later than 

10 July 31 of every odd-numbered year beginning with 

11 the first such year after the date of submission of 

12 the first Strategic Federal Plan to Improve Diag13 nosis under paragraph (1), the Council shall pre14 pare, submit to the Secretary and Congress, and 

15 make publicly available an updated Strategic Fed16 eral Plan to Improve Diagnosis that includes— 

17 (A) such updates as the Council deter18 mines to be appropriate; 

19 (B) information on the overall progress of 

20 the Federal Government in reducing barriers to 

21 research on, and supporting projects to im22 prove, diagnosis in health care; and 

23 (C) legislative and administrative policy 

24 recommendations, including addressing any 


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1 needs for greater legislative authority to meet 

2 the objectives listed in subsection (b). 

3 SEC. 4. AUTHORIZATION OF APPROPRIATIONS. 

4 There is authorized to be appropriated to carry out 

5 this Act (including the amendments made by this Act) 

6 $8,000,000 for each of fiscal years 2021 through 2025, 

7 to remain available until expended. 

Æ 


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