I 

118TH CONGRESS 

2D SESSION H. R. 8412 

To modernize clinical trials and remove barriers for participation in clinical 

trials, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 15, 2024 

Mr. RUIZ (for himself and Mr. BUCSHON) introduced the following bill; which 

was referred to the Committee on Energy and Commerce, and in addition 

to the Committee on Ways and Means, for a period to be subsequently 

determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To modernize clinical trials and remove barriers for 

participation in clinical trials, 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 ‘‘Clinical Trial Mod5 ernization Act’’. 

6 SEC. 2. DEFINITION. 

7 For purposes of this Act, the term ‘‘underrepresented 

8 population’’ has the meaning given such term by the Na9 tional Institutes of Health for purposes of the Toolkit for 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
2 

•HR 8412 IH

1 Patient-Focused Therapy Development (as published on 

2 April 1, 2024), in addition to such populations recognized 

3 by the Food and Drug Administration. 

4 SEC. 3. GRANTS TO ENCOURAGE CLINICAL TRIAL ENROLL5 MENT BY UNDERREPRESENTED POPU6 LATIONS. 

7 (a) IN GENERAL.—The Secretary may issue grants 

8 to and enter into contracts with entities to support com9 munity education, outreach, and recruitment activities for 

10 clinical trials with respect to devices and drugs, including 

11 vaccines, for diseases or conditions that have a dispropor12 tionate impact on underrepresented populations. Such ac13 tivities may include— 

14 (1) working with community clinical trial sites, 

15 including community health centers, academic health 

16 centers, sites in rural communities, and other facili17 ties; 

18 (2) training health care personnel, including po19 tential clinical trial investigators, with a focus on 

20 significantly increasing the number of underrep21 resented populations of health care personnel who 

22 are clinical trial investigators at the community sites 

23 for ongoing clinical trials; 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
3 

•HR 8412 IH

1 (3) engaging community stakeholders to en2 courage participation in clinical trials, especially in 

3 underrepresented populations; and 

4 (4) fostering partnerships with community5 based organizations serving underrepresented popu6 lations, including employee unions and frontline 

7 health care workers. 

8 (b) PRIORITY FOR GRANT AND CONTRACT

9 AWARDS.—In awarding grants and contracts under this 

10 section, the Secretary shall prioritize entities that— 

11 (1) develop educational, recruitment, and train12 ing materials in multiple languages; or 

13 (2) undertake clinical trial outreach efforts in 

14 communities that are traditionally underrepresented 

15 in clinical trials, such as tribal areas. 

16 (c) AUTHORIZATION OF APPROPRIATIONS.—There is 

17 authorized to be appropriated for fiscal years 2024 and 

18 2025 such sums as may be necessary to carry out this 

19 section. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
4 

•HR 8412 IH

1 SEC. 4. ENCOURAGEMENT OF CLINICAL TRIAL PARTICIPA2 TION BY UNDERREPRESENTED POPU3 LATIONS THROUGH PAYMENT OF STUDY PAR4 TICIPANT CLINICAL TRIAL EXPENSES AND 

5 PROVISION OF DIGITAL HEALTH TECH6 NOLOGIES. 

7 (a) IN GENERAL.—Section 1128A(i)(6)(F) of the So8 cial Security Act (42 U.S.C. 1320a–7a(i)(6)(F)) is amend9 ed by striking ‘‘ under regulations);’’ and inserting the fol10 lowing: ‘‘under regulations, including— 

11 ‘‘(i) remuneration offered or trans12 ferred to an individual while participating 

13 in a clinical trial, as defined in subsection 

14 (d) of the first section 2709 of the Public 

15 Health Service Act for expenses incurred 

16 as part of the trial, other than patient 

17 cost-sharing obligations, including without 

18 limitation travel, transportation, and meal 

19 expenses, so long as such remuneration is 

20 made available to all study participants 

21 and facilitates inclusion of patients from 

22 all relevant demographic and socioeconomic 

23 populations and geographies including 

24 rural communities; and 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
5 

•HR 8412 IH

1 ‘‘(ii) the free provision to an indi2 vidual of digital health technologies 

3 where— 

4 ‘‘(I) the use of the digital health 

5 technologies is intended to facilitate 

6 the participation of underrepresented 

7 patient populations; and 

8 ‘‘(II) the digital health tech9 nologies are necessary for participa10 tion in such trial;’’. 

11 (b) CONFORMING AMENDMENT TO THE ANTI-KICK12 BACK STATUTE.—Section 1128B(b)(3)of the Social Secu13 rity Act (42 U.S.C. 1320a–7b(b)(3)) is amended— 

14 (1) by striking ‘‘and’’ at the end of subpara15 graph (K); 

16 (2) by striking the period at the end of sub17 paragraph (L) and inserting ‘‘; and’’; 

18 (3) by aligning the left margin of each of sub19 paragraphs (J) and (K) with the left margin of sub20 paragraph (I); and 

21 (4) by inserting after subparagraph (L) the fol22 lowing new subparagraphs: 

23 ‘‘(M) any remuneration offered or trans24 ferred to an individual while participating in a 

25 clinical trial (as defined in subsection (d) of the 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
6 

•HR 8412 IH

1 first section 2709 of the Public Health Service 

2 Act) for expenses incurred as part of the trial, 

3 other than patient cost-sharing obligations, in4 cluding without limitation travel, transpor5 tation, and meal expenses, so long as such re6 muneration is made available to all study par7 ticipants and facilitates inclusion of patients 

8 from all relevant demographic and socio9 economic populations and geographies, includ10 ing rural communities; and 

11 ‘‘(N) the free provision to an individual of 

12 digital health technologies where— 

13 ‘‘(i) the use of the digital health tech14 nologies is intended to facilitate in any 

15 phase of a clinical trial (as so defined) the 

16 participation of underrepresented patient 

17 populations; and 

18 ‘‘(ii) the digital health technologies 

19 are necessary to such participation.’’. 

20 (c) EFFECTIVE DATE.—The amendments made by 

21 this section shall apply to remuneration provided on or 

22 after the date of enactment of this Act. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
7 

•HR 8412 IH

1 SEC. 5. ENCOURAGEMENT OF CLINICAL TRIAL ACCESSI2 BILITY THROUGH SUPPORT OF CLINICAL 

3 TRIAL COST-SHARING. 

4 The payment of patient cost-sharing obligations asso5 ciated with participation in a clinical trial (as defined in 

6 subsection (d) of the first section 2709 of the Public 

7 Health Service Act) or for which a diversity action plan 

8 is required pursuant to sections 505(z) or 520(g)(9) of 

9 the Federal Food, Drug, and Cosmetic Act by drug or de10 vice manufacturers or their agents for their clinical trial 

11 participants shall not be considered a violation of section 

12 1128A of the Social Security Act (42 U.S.C. 1320a–7a) 

13 (commonly known as the ‘‘Civil Monetary Penalties 

14 Law’’), section 1128B of the Social Security Act (42 

15 U.S.C. 1320a–7b), or sections 3729 through 3733 of title 

16 31, United States Code (commonly known as the ‘‘False 

17 Claims Act’’), provided that the following requirements 

18 are met: 

19 (1) The trial and any coverage of items or serv20 ices provided in the trial is consistent with all appli21 cable coverage rules by any Federal health care pro22 grams providing coverage and reimbursement for 

23 beneficiaries participating in the trial as study sub24 jects, including but not limited to, any existing trial 

25 qualification requirements imposed by the Centers 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
8 

•HR 8412 IH

1 for Medicare & Medicaid Services for Medicare cov2 erage of the trial. 

3 (2) The proposed arrangement for the payment 

4 of patient cost-sharing obligations is a reasonable 

5 means of facilitating enrollment of an underrep6 resented set of subjects or reducing the likelihood of 

7 attrition in the trial by removing a potential finan8 cial barrier to participation in the trial. 

9 (3) Any sponsor payments of participating pa10 tient cost-sharing obligations must be available 

11 throughout the entirety of the clinical trial. 

12 (4) Any sponsor payments of participating pa13 tient cost-sharing obligations are not contingent on 

14 the future use or purchase of any product or service. 

15 (5) Any sponsor payments of participating pa16 tient cost-sharing obligations will not be provided in 

17 excess of the patient’s cost-sharing obligations under 

18 relevant Federal health care programs. 

19 (6) A participating patient receiving cost-shar20 ing assistance from a sponsor will be required to 

21 agree not to accept other financial assistance to 

22 cover the patient’s cost-sharing obligations. 

23 (7) Any sponsor payments of participating pa24 tient cost-sharing obligations will cease upon the paVerDate Sep 11 2014 02:57 Jun 22, 2024 Jkt 049200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H8412.IH H8412

kjohnson on DSK7ZCZBW3PROD with $$_JOB
9 

•HR 8412 IH

1 tient’s disenrollment from the clinical trial or the 

2 conclusion of the clinical trial, whichever is first. 

3 (8) The proposed arrangement for the payment 

4 of patient cost-sharing obligations includes the fol5 lowing elements to protect against improper in6 creased costs or inappropriate utilization of items 

7 and services reimbursed in whole or in part under 

8 Federal health care programs: 

9 (A) The availability of cost-sharing sub10 sidies will not be advertised, but may be dis11 closed as required or permitted by law in the in12 formed consent forms, protocol, or other docu13 mentation associated with the study. 

14 (B) Participating Federal health care pro15 gram beneficiaries must satisfy formal, objec16 tive, and predetermined enrollment criteria and 

17 execute an informed consent document. 

18 (C) The sponsor must enter into a written 

19 agreement with investigators that requires the 

20 investigators to comply with the written pro21 tocol for the study and to be subject to over22 sight and monitoring by an institutional review 

23 board or other similar body providing inde24 pendent oversight for the trial. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
10 

•HR 8412 IH

1 (D) Total enrollment for the trial is 

2 capped. 

3 SEC. 6. EXCLUSION FROM GROSS INCOME FOR REMUNERA4 TION PROVIDED BY SPONSORS OF APPROVED 

5 CLINICAL TRIALS TO PARTICIPANTS. 

6 (a) IN GENERAL.—Part III of subchapter B of chap7 ter 1 of the Internal Revenue Code of 1986 is amended 

8 by inserting before section 140 the following new section: 

9 ‘‘SEC. 139J. REMUNERATION PROVIDED BY SPONSORS OF 

10 APPROVED CLINICAL TRIALS TO PARTICI11 PANTS. 

12 ‘‘(a) IN GENERAL.—Gross income shall not include 

13 the value of any payment received by an individual from 

14 participation in an approved clinical trial (as defined in 

15 subsection (d) of the first section 2709 of the Public 

16 Health Service Act). 

17 ‘‘(b) LIMITATION.—The amount excluded from gross 

18 income under subsection (a) for any taxable year shall not 

19 exceed $2,000.’’. 

20 (b) CLERICAL AMENDMENT.—The table of sections 

21 for part III of subchapter B of chapter 1 of the Internal 

22 Revenue Code of 1986 is amended by inserting before the 

23 item relating to section 140 the following new item: 

‘‘Sec. 139J. Remuneration provided by sponsors of approved clinical trials to 

participants.’’. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
11 

•HR 8412 IH

1 (c) EFFECTIVE DATE.—The amendments made by 

2 this section shall apply to taxable years beginning after 

3 the date of enactment of this Act. 

Æ 


kjohnson on DSK7ZCZBW3PROD with $$_JOB