I 
119TH CONGRESS 
1ST SESSION H. R. 3521 
To modernize clinical trials and remove barriers for participation in clinical 
trials, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 20, 2025 
Mr. RUIZ (for himself and Mr. PFLUGER) 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 provi-
sions 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Clinical Trial Mod-
ernization Act’’. 
SEC. 2. DEFINITION. 
For purposes of this Act, the term ‘‘underrepresented 
population’’ has the meaning given such term by the Na-
tional Institutes of Health for purposes of the Toolkit for 
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Patient-Focused Therapy Development (as published on 
April 1, 2024), in addition to such populations recognized 
by the Food and Drug Administration. 
SEC. 3. GRANTS TO ENCOURAGE CLINICAL TRIAL ENROLL-
MENT 
BY 
UNDERREPRESENTED 
POPU-
LATIONS. 
(a) IN GENERAL.—The Secretary may issue grants 
to and enter into contracts with entities to support com-
munity education, outreach, and recruitment activities for 
clinical trials with respect to devices and drugs, including 
vaccines, for diseases or conditions that have a dispropor-
tionate impact on underrepresented populations. Such ac-
tivities may include— 
(1) working with community clinical trial sites, 
including community health centers, academic health 
centers, sites in rural communities, and other facili-
ties; 
(2) training health care personnel, including po-
tential clinical trial investigators, with a focus on 
significantly increasing the number of underrep-
resented populations of health care personnel who 
are clinical trial investigators at the community sites 
for ongoing clinical trials; 
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(3) engaging community stakeholders to en-
courage participation in clinical trials, especially in 
underrepresented populations; and 
(4) fostering partnerships with community- 
based organizations serving underrepresented popu-
lations, including employee unions and frontline 
health care workers. 
(b) 
PRIORITY
FOR
GRANT
AND
CONTRACT 
AWARDS.—In awarding grants and contracts under this 
section, the Secretary shall prioritize entities that— 
(1) develop educational, recruitment, and train-
ing materials in multiple languages; or 
(2) undertake clinical trial outreach efforts in 
communities that are traditionally underrepresented 
in clinical trials, such as tribal areas. 
(c) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated for fiscal years 2025 and 
2026 such sums as may be necessary to carry out this 
section. 
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SEC. 4. ENCOURAGEMENT OF CLINICAL TRIAL PARTICIPA-
TION 
BY 
UNDERREPRESENTED 
POPU-
LATIONS THROUGH PAYMENT OF STUDY PAR-
TICIPANT CLINICAL TRIAL EXPENSES AND 
PROVISION 
OF 
DIGITAL 
HEALTH 
TECH-
NOLOGIES. 
(a) IN GENERAL.—Section 1128A(i)(6)(F) of the So-
cial Security Act (42 U.S.C. 1320a–7a(i)(6)(F)) is amend-
ed by striking ‘‘ under regulations);’’ and inserting the fol-
lowing: ‘‘under regulations, including— 
‘‘(i) remuneration offered or trans-
ferred to an individual while participating 
in a clinical trial, as defined in subsection 
(d) of the first section 2709 of the Public 
Health Service Act for expenses incurred 
as part of the trial, other than patient 
cost-sharing obligations, including without 
limitation travel, transportation, and meal 
expenses, so long as such remuneration is 
made available to all study participants 
and facilitates inclusion of patients from 
all relevant demographic and socioeconomic 
populations 
and 
geographies 
including 
rural communities; and 
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‘‘(ii) the free provision to an indi-
vidual 
of 
digital 
health 
technologies 
where— 
‘‘(I) the use of the digital health 
technologies is intended to facilitate 
the participation of underrepresented 
patient populations; and 
‘‘(II) the digital health tech-
nologies are necessary for participa-
tion in such trial;’’. 
(b) CONFORMING AMENDMENT TO THE ANTI-KICK-
BACK STATUTE.—Section 1128B(b)(3) of the Social Secu-
rity Act (42 U.S.C. 1320a–7b(b)(3)) is amended— 
(1) by striking ‘‘and’’ at the end of subpara-
graph (K); 
(2) by striking the period at the end of sub-
paragraph (L) and inserting ‘‘; and’’; 
(3) by aligning the left margin of each of sub-
paragraphs (J) and (K) with the left margin of sub-
paragraph (I); and 
(4) by inserting after subparagraph (L) the fol-
lowing new subparagraphs: 
‘‘(M) any remuneration offered or trans-
ferred to an individual while participating in a 
clinical trial (as defined in subsection (d) of the 
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first section 2709 of the Public Health Service 
Act) for expenses incurred as part of the trial, 
other than patient cost-sharing obligations, in-
cluding without limitation travel, transpor-
tation, and meal expenses, so long as such re-
muneration is made available to all study par-
ticipants and facilitates inclusion of patients 
from all relevant demographic and socio-
economic populations and geographies, includ-
ing rural communities; and 
‘‘(N) the free provision to an individual of 
digital health technologies where— 
‘‘(i) the use of the digital health tech-
nologies is intended to facilitate in any 
phase of a clinical trial (as so defined) the 
participation of underrepresented patient 
populations; and 
‘‘(ii) the digital health technologies 
are necessary to such participation.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to remuneration provided on or 
after the date of enactment of this Act. 
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SEC. 5. ENCOURAGEMENT OF CLINICAL TRIAL ACCESSI-
BILITY THROUGH SUPPORT OF CLINICAL 
TRIAL COST-SHARING. 
The payment of patient cost-sharing obligations asso-
ciated with participation in a clinical trial (as defined in 
subsection (d) of the first section 2709 of the Public 
Health Service Act) or for which a diversity action plan 
is required pursuant to sections 505(z) or 520(g)(9) of 
the Federal Food, Drug, and Cosmetic Act by drug or de-
vice manufacturers or their agents for their clinical trial 
participants shall not be considered a violation of section 
1128A of the Social Security Act (42 U.S.C. 1320a–7a) 
(commonly known as the ‘‘Civil Monetary Penalties 
Law’’), section 1128B of the Social Security Act (42 
U.S.C. 1320a–7b), or sections 3729 through 3733 of title 
31, United States Code (commonly known as the ‘‘False 
Claims Act’’), provided that the following requirements 
are met: 
(1) The trial and any coverage of items or serv-
ices provided in the trial is consistent with all appli-
cable coverage rules by any Federal health care pro-
grams providing coverage and reimbursement for 
beneficiaries participating in the trial as study sub-
jects, including but not limited to, any existing trial 
qualification requirements imposed by the Centers 
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for Medicare & Medicaid Services for Medicare cov-
erage of the trial. 
(2) The proposed arrangement for the payment 
of patient cost-sharing obligations is a reasonable 
means of facilitating enrollment of an underrep-
resented set of subjects or reducing the likelihood of 
attrition in the trial by removing a potential finan-
cial barrier to participation in the trial. 
(3) Any sponsor payments of participating pa-
tient cost-sharing obligations must be available 
throughout the entirety of the clinical trial. 
(4) Any sponsor payments of participating pa-
tient cost-sharing obligations are not contingent on 
the future use or purchase of any product or service. 
(5) Any sponsor payments of participating pa-
tient cost-sharing obligations will not be provided in 
excess of the patient’s cost-sharing obligations under 
relevant Federal health care programs. 
(6) A participating patient receiving cost-shar-
ing assistance from a sponsor will be required to 
agree not to accept other financial assistance to 
cover the patient’s cost-sharing obligations. 
(7) Any sponsor payments of participating pa-
tient cost-sharing obligations will cease upon the pa-
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tient’s disenrollment from the clinical trial or the 
conclusion of the clinical trial, whichever is first. 
(8) The proposed arrangement for the payment 
of patient cost-sharing obligations includes the fol-
lowing elements to protect against improper in-
creased costs or inappropriate utilization of items 
and services reimbursed in whole or in part under 
Federal health care programs: 
(A) The availability of cost-sharing sub-
sidies will not be advertised, but may be dis-
closed as required or permitted by law in the in-
formed consent forms, protocol, or other docu-
mentation associated with the study. 
(B) Participating Federal health care pro-
gram beneficiaries must satisfy formal, objec-
tive, and predetermined enrollment criteria and 
execute an informed consent document. 
(C) The sponsor must enter into a written 
agreement with investigators that requires the 
investigators to comply with the written pro-
tocol for the study and to be subject to over-
sight and monitoring by an institutional review 
board or other similar body providing inde-
pendent oversight for the trial. 
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(D) Total enrollment for the trial is 
capped. 
SEC. 6. EXCLUSION FROM GROSS INCOME FOR REMUNERA-
TION PROVIDED BY SPONSORS OF APPROVED 
CLINICAL TRIALS TO PARTICIPANTS. 
(a) IN GENERAL.—Part III of subchapter B of chap-
ter 1 of the Internal Revenue Code of 1986 is amended 
by inserting before section 140 the following new section: 
‘‘SEC. 139J. REMUNERATION PROVIDED BY SPONSORS OF 
APPROVED CLINICAL TRIALS TO PARTICI-
PANTS. 
‘‘(a) IN GENERAL.—Gross income shall not include 
the value of any payment received by an individual from 
participation in an approved clinical trial (as defined in 
subsection (d) of the first section 2709 of the Public 
Health Service Act). 
‘‘(b) LIMITATION.—The amount excluded from gross 
income under subsection (a) for any taxable year shall not 
exceed $2,000.’’. 
(b) CLERICAL AMENDMENT.—The table of sections 
for part III of subchapter B of chapter 1 of the Internal 
Revenue Code of 1986 is amended by inserting before the 
item relating to section 140 the following new item: 
‘‘Sec. 139J. Remuneration provided by sponsors of approved clinical trials to 
participants.’’. 
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(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to taxable years beginning after 
the date of enactment of this Act. 
SEC. 7. RULE OF CONSTRUCTION. 
Nothing in section 4 or section 5 of this Act shall 
be construed to limit or narrow in any way any other pro-
tections from liability under section 1128A or 1128B of 
the Social Security Act (42 U.S.C. 1320a–7a; 1320a–7b) 
or sections 3729 through 3733 of title 31, United States 
Code, whether such other protections are set forth in stat-
ute, regulation, or any form of guidance, that may apply 
to any practice or arrangement encouraging participation 
in or accessibility of clinical trials. 
Æ 
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