Improving Diagnosis in Medicine Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 5014 To improve the quality, appropriateness, and effectiveness of diagnosis in health care, and for other purposes. IN THE HOUSE OF REPRESENTATIVES NOVEMBER 8, 2019 Mr. LUJA´N (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. 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 2019’’. 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 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5014.IH H5014 kjohnson on DSK79L0C42 with BILLS 2 •HR 5014 IH (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 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5014.IH H5014 kjohnson on DSK79L0C42 with BILLS 3 •HR 5014 IH ‘‘(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 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5014.IH H5014 kjohnson on DSK79L0C42 with BILLS 4 •HR 5014 IH 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 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5014.IH H5014 kjohnson on DSK79L0C42 with BILLS 5 •HR 5014 IH (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 at least 1 designee from each of the following, 21 appointed by the head of the applicable depart- 22 ment or agency: 23 (i) The Centers for Disease Control 24 and Prevention. 25 VerDate Sep 11 2014 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5014.IH H5014 kjohnson on DSK79L0C42 with BILLS 6 •HR 5014 IH (ii) The Centers for Medicare & Med- 1 icaid Services. 2 (iii) The Department of Veterans Af- 3 fairs. 4 (iv) The Congressionally Directed 5 Medical Research Program of the Depart- 6 ment of Defense. 7 (v) The National Institutes of Health, 8 including designees from— 9 (I) the National Cancer Institute; 10 (II) the National Center for Ad- 11 vancing Translational Sciences; 12 (III) the National Institute of Al- 13 lergy and Infectious Diseases; 14 (IV) the National Heart, Lung, 15 and Blood Institute; 16 (V) the National Institute of 17 Neurological Disorders and Stroke; 18 (VI) the National Library of 19 Medicine; and 20 (VII) such other national re- 21 search institutes and national centers 22 as may be appropriate, as determined 23 by the Director of the National Insti- 24 tutes of Health. 25 VerDate Sep 11 2014 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5014.IH H5014 kjohnson on DSK79L0C42 with BILLS 7 •HR 5014 IH (B) ADDITIONAL MEMBERS.—In addition 1 to the designees under subparagraph (A), the 2 Council may include such other designees from 3 Federal departments or agencies as the Chair- 4 person of the Council deems appropriate. 5 (C) DESIGNATION.—A person appointed to 6 the Council as a designee shall be a senior offi- 7 cial or employee of the department or agency 8 whose responsibilities and subject matter exper- 9 tise are relevant to the Council’s objectives list- 10 ed in subsection (b), as determined by the des- 11 ignating official. 12 (d) STRATEGIC PLAN; REPORTS.— 13 (1) STRATEGIC FEDERAL PLAN TO IMPROVE DI- 14 AGNOSIS IN HEALTH CARE.—Not later than 18 15 months after the date of enactment of this Act, the 16 Council shall develop, submit to the Secretary and 17 Congress, and make publicly available a strategic 18 plan, to be known as the Strategic Federal Plan to 19 Improve Diagnosis, that, consistent with the objec- 20 tives listed in subsection (b)— 21 (A) identifies coordinated opportunities to 22 enhance scientific research and reduce systemic 23 barriers in order to improve diagnosis in health 24 care; and 25 VerDate Sep 11 2014 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5014.IH H5014 kjohnson on DSK79L0C42 with BILLS 8 •HR 5014 IH (B) includes legislative and administrative 1 policy recommendations. 2 (2) REPORTS TO CONGRESS.—Not later than 3 July 31 of every odd-numbered year beginning with 4 the first such year after the date of submission of 5 the first Strategic Federal Plan to Improve Diag- 6 nosis under paragraph (1), the Council shall pre- 7 pare, submit to the Secretary and Congress, and 8 make publicly available an updated Strategic Fed- 9 eral Plan to Improve Diagnosis that includes— 10 (A) such updates as the Council deter- 11 mines to be appropriate; 12 (B) information on the overall progress of 13 the Federal Government in reducing barriers to 14 research on, and supporting projects to im- 15 prove, diagnosis in health care; and 16 (C) legislative and administrative policy 17 recommendations, including addressing any 18 needs for greater legislative authority to meet 19 the objectives listed in subsection (b). 20 SEC. 4. AUTHORIZATION OF APPROPRIATIONS. 21 There is authorized to be appropriated to carry out 22 this Act (including the amendments made by this Act) 23 VerDate Sep 11 2014 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5014.IH H5014 kjohnson on DSK79L0C42 with BILLS 9 •HR 5014 IH $8,000,000 for each of fiscal years 2021 through 2025, 1 to remain available until expended. 2 Æ VerDate Sep 11 2014 04:15 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\H5014.IH H5014 kjohnson on DSK79L0C42 with BILLS