II 

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. LUJA ́N) 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 2022’’. 

6 SEC. 2. RESEARCH PROGRAM TO IMPROVE DIAGNOSTIC 

7 SAFETY AND QUALITY. 

8 Part B of title IX of the Public Health Service Act 

9 (42 U.S.C. 299b et seq.) is amended by adding at the end 

10 the following: 


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1 ‘‘SEC. 918. RESEARCH PROGRAM TO IMPROVE DIAGNOSTIC 

2 SAFETY AND QUALITY. 

3 ‘‘(a) IN GENERAL.—The Director shall establish a 

4 comprehensive program of research and quality improve5 ment to— 

6 ‘‘(1) assess and understand diagnostic errors, 

7 including diagnostic delays, and how to eliminate 

8 common failures in the diagnostic process that lead 

9 to significant patient harm; and 

10 ‘‘(2) identify, develop, implement, and dissemi11 nate evidence-based strategies and best practices for 

12 improving diagnostic quality, safety, and health care 

13 value. 

14 ‘‘(b) ACTIVITIES.—The program established under 

15 subsection (a) shall include the following: 

16 ‘‘(1) CONTINUUM OF RESEARCH.—A portfolio 

17 of conducted and supported activities that is con18 sistent with the general, research, implementation, 

19 and dissemination activities of the Center for Qual20 ity Improvement and Patient Safety, as described in 

21 section 933, including— 

22 ‘‘(A) investigator-initiated research to as23 sess diagnostic errors and identify improved 

24 methods to prevent errors and the harm they 

25 cause; 


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1 ‘‘(B) translation and synthesis of research 

2 findings and development of tools for imple3 menting prevention strategies into practice; 

4 ‘‘(C) implementation research to refine evi5 dence-based tools for improving diagnostic proc6 esses and effectively integrate these solutions 

7 into practice; and 

8 ‘‘(D) dissemination to promote implemen9 tation of effective methods, strategies and tools 

10 for wide-scale improvement. 

11 ‘‘(2) RESEARCH CENTERS OF DIAGNOSTIC EX12 CELLENCE.—Consistent with section 911(b), such 

13 Centers shall link research directly with clinical 

14 practice in geographically diverse locations through15 out the United States, and may include— 

16 ‘‘(A) academic medical and institutional re17 search centers that combine demonstrated mul18 tidisciplinary expertise in diagnostic outcomes 

19 or quality improvement research with linkages 

20 directly or through national, state or local 

21 stakeholder partner organizations to relevant 

22 sites of care; and 

23 ‘‘(B) provider-based research networks, in24 cluding plan, facility, or delivery system sites of 

25 care (especially primary care), that can evaluate 


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1 outcomes and evaluate and promote quality im2 provement approaches. 

3 ‘‘(3) FINANCIAL ASSISTANCE.—The Director 

4 may provide financial assistance to assist in meeting 

5 the costs of planning and establishing new centers, 

6 as well as operating existing and new centers, pursu7 ant to section 902(c). 

8 ‘‘(4) STAKEHOLDER ENGAGEMENT.—The Di9 rector shall identify and enter into a supporting 

10 agreement (grant or contract) with a nonprofit enti11 ty that convenes a coalition of diverse health care 

12 stakeholders for the purpose of— 

13 ‘‘(A) raising attention to diagnostic safety 

14 and quality concerns; 

15 ‘‘(B) facilitating learning, adoption and 

16 spread of effective quality improvement inter17 ventions; and 

18 ‘‘(C) catalyzing novel actions by individual 

19 member organizations to reduce harms from di20 agnostic error and improve patient outcomes. 

21 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.— 

22 ‘‘(1) IN GENERAL.—To carry out this section, 

23 there is authorized to be appropriated $20,000,000 

24 for fiscal year 2023, $25,000,000 for fiscal year 


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1 2024, $30,000,000 for fiscal year 2025, and 

2 $35,000,000 for each of fiscal years 2026 and 2027. 

3 ‘‘(2) RESERVATION.—Of the amount appro4 priated under paragraph (1) for a fiscal year, 

5 $700,000 shall be allocated to carrying out the pur6 pose described in subsection (b)(4). 

7 ‘‘(3) AVAILABILITY.—Amounts appropriated 

8 under this section shall remain available until ex9 pended.’’. 

10 SEC. 3. FELLOWSHIPS AND TRAINING GRANTS. 

11 (a) RUTH KIRSCHSTEIN AWARDS.—Section 487(a) of 

12 the Public Health Service Act (42 U.S.C. 288(a)) is 

13 amended by adding at the end the following: 

14 ‘‘(5) For purposes of the program under this sub15 section, biomedical and behavioral research includes diag16 nostic safety and quality research.’’. 

17 (b) AHRQ PROGRAMS.—Section 902(b)(1) of the 

18 Public Health Service Act (42 U.S.C. 299a(b)(1)) is 

19 amended— 

20 (1) by inserting ‘‘and diagnostic safety and 

21 quality’’ after ‘‘subsection (a)’’; and 

22 (2) by striking ‘‘under section 487(d)(3)’’ and 

23 inserting ‘‘for purposes of carrying out section 487’’. 


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1 SEC. 4. QUALITY MEASURE DEVELOPMENT. 

2 Section 931(c)(2) of the Public Health Service Act 

3 (42 U.S.C. 299b–31(c)(2)) is amended— 

4 (1) by redesignating subparagraphs (B) 

5 through (J) as subparagraphs (C) through (K), re6 spectively; and 

7 (2) by inserting after subparagraph (A) the fol8 lowing: 

9 ‘‘(B) diagnostic safety and quality;’’. 

10 SEC. 5. DATA FOR RESEARCH AND IMPROVEMENT. 

11 Section 937(f) of the Public Health Service Act (42 

12 U.S.C. 299b–37(f)) is amended— 

13 (1) by striking ‘‘The Secretary’’ and inserting 

14 the following: 

15 ‘‘(1) IN GENERAL.—The Secretary’’; and 

16 (2) adding at the end the following: 

17 ‘‘(2) CONSULTATION WITH EXPERT PANEL.—In 

18 carrying out paragraph (1), the Secretary, in coordi19 nation with the Director, the Director of the Centers 

20 for Medicare & Medicaid Services, the National Co21 ordinator for Health Information Technology, and 

22 the National Library of Medicine, shall convene an 

23 expert panel to consider and make recommendations 

24 regarding the types, sources, and availability of data 

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1 fied in section 918, including data related to racial, 

2 ethnic, and language attributes; gender, age, geog3 raphy, and socioeconomic conditions; the specificity, 

4 interoperability, and socio-technical aspects of elec5 tronic vocabularies and ontologies related to pre6 senting symptoms and diagnostic certainty; and the 

7 development and use of symptom-based clinical reg8 istries. Such panel shall consider enhanced data ca9 pabilities that are necessary to support both re10 search and improvement of diagnostic safety and 

11 quality.’’. 

12 SEC. 6. INTERAGENCY COUNCIL ON IMPROVING DIAGNOSIS 

13 IN HEALTH CARE. 

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

15 Human Services (in this section referred to as the ‘‘Sec16 retary’’) shall establish within the Office of the Secretary 

17 an interagency council to be known as the Interagency 

18 Council on Improving Diagnosis in Health Care (referred 

19 to in this section as the ‘‘Council’’). 

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

21 be the following: 

22 (1) Enhance the quality, appropriateness, and 

23 effectiveness of diagnosis in health care through— 

24 (A) the establishment and support of a 

25 broad base of scientific research; 


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1 (B) the dissemination and implementation 

2 of the results of such research; and 

3 (C) the promotion of improvements in clin4 ical and health system practices. 

5 (2) Identify and eliminate systemic barriers to 

6 supporting research in improving diagnosis in health 

7 care. 

8 (3) Identify knowledge gaps, research and data 

9 needs, and opportunities congruent with agency mis10 sions to strengthen the clinical and translational re11 search pipeline to improve diagnostic safety and 

12 quality, including potential collaborative research ini13 tiatives among 2 or more agencies, offices, institutes, 

14 or centers within the Department of Health and 

15 Human Services or other Federal agencies or offices. 

16 (c) MEMBERSHIP.— 

17 (1) CHAIRPERSON.—The Director of the Agen18 cy for Healthcare Research and Quality (or the Di19 rector’s designee) shall be the Chairperson of the 

20 Council. 

21 (2) MEMBERS.— 

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

23 Chairperson, the Council shall be comprised of 

24 the following: 


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1 (i) At least 1 designee from each of 

2 the following, appointed by the head of the 

3 applicable department or agency: 

4 (I) The Centers for Disease Con5 trol and Prevention. 

6 (II) The Centers for Medicare & 

7 Medicaid Services. 

8 (III) The Department of Vet9 erans Affairs. 

10 (IV) The Congressionally Di11 rected Medical Research Program of 

12 the Department of Defense. 

13 (V) The Office of the National 

14 Coordinator for Health Information 

15 Technology. 

16 (ii) Designees from the National Insti17 tutes of Health, including a least 1 des18 ignee from each of the following: 

19 (I) The National Cancer Insti20 tute. 

21 (II) The National Center for Ad22 vancing Translational Sciences. 

23 (III) The National Institute of 

24 Allergy and Infectious Diseases. 


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1 (IV) The National Heart, Lung, 

2 and Blood Institute. 

3 (V) The National Institute of 

4 Neurological Disorders and Stroke. 

5 (VI) The National Library of 

6 Medicine. 

7 (VII) The National Institute on 

8 Minority Health and Health Dispari9 ties. 

10 (VIII) The National Institute of 

11 Nursing Research. 

12 (IX) The Eunice Kennedy Shriv13 er National Institute of Child Health 

14 and Human Development. 

15 (iii) Designees from such other na16 tional research institutes and national cen17 ters as may be appropriate, as determined 

18 by the Director of the National Institutes 

19 of Health. 

20 (B) ADDITIONAL MEMBERS.—In addition 

21 to the designees under subparagraph (A), the 

22 Council may include such other designees from 

23 Federal departments or agencies as the Chair24 person of the Council deems appropriate. 


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1 (C) DESIGNATION.—A person appointed to 

2 the Council as a designee shall be a senior offi3 cial or employee of the department or agency 

4 whose responsibilities and subject matter exper5 tise are relevant to the Council’s objectives list6 ed in subsection (b), as determined by the des7 ignating official. 

8 (d) STRATEGIC PLAN; REPORTS.— 

9 (1) STRATEGIC FEDERAL PLAN TO IMPROVE DI10 AGNOSIS IN HEALTH CARE.—Not later than 18 

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

12 Council shall develop, submit to the Secretary and 

13 Congress, and make publicly available a strategic 

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

15 Improve Diagnosis, that, consistent with the objec16 tives listed in subsection (b)— 

17 (A) identifies coordinated opportunities to 

18 enhance scientific research and reduce systemic 

19 barriers in order to improve diagnosis in health 

20 care; and 

21 (B) includes legislative and administrative 

22 policy recommendations, including opportunities 

23 to remove barriers to, and enhance, inter-agen24 cy coordination in the planning, conduct, and 

25 funding of, such research. 


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

2 July 31 of every odd-numbered year beginning with 

3 the first such year after the date of submission of 

4 the first Strategic Federal Plan to Improve Diag5 nosis under paragraph (1), the Council shall pre6 pare, submit to the Secretary and Congress, and 

7 make publicly available an updated Strategic Fed8 eral Plan to Improve Diagnosis that includes— 

9 (A) such updates as the Council deter10 mines to be appropriate; 

11 (B) information on the overall progress of 

12 the Federal Government in reducing barriers to 

13 research on, and supporting projects to im14 prove, diagnosis in health care; and 

15 (C) legislative and administrative policy 

16 recommendations, including addressing any 

17 needs for greater legislative authority to meet 

18 the objectives listed in subsection (b). 

19 (e) AUTHORIZATION OF APPROPRIATIONS.—To carry 

20 out this section, there are authorized to be appropriated 

21 $1,500,000 for each of fiscal years 2023 through 2027. 

22 SEC. 7. NATIONAL ACADEMIES REPORT. 

23 (a) IN GENERAL.—The Director of the Agency for 

24 Healthcare Research and Quality shall seek to enter into 

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1 neering, and Medicine under which such National Acad2 emies conducts a study and issues a report on disparities 

3 in diagnostic safety and quality that— 

4 (1) identifies what is known about the burden 

5 and causes of such disparities, including racial, eth6 nic, socioeconomic, age, gender, geography, language 

7 proficiency, and intersectional interactions; and 

8 (2) includes recommendations on specific ac9 tions that policymakers, researchers, clinicians, and 

10 other stakeholders can take to eliminate such bur11 dens. 

12 (b) AUTHORIZATION OF APPROPRIATIONS.—To carry 

13 out this section, there is authorized to be appropriated 

14 $1,500,000 for fiscal year 2023, to remain available until 

15 expended. 

Æ 


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