S. 4440

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4440 Introduced in Senate (IS)]

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119th CONGRESS
2d Session
S. 4440

To modernize clinical trials and remove barriers for participation in 
clinical trials, and for other purposes.

_______________________________________________________________________

IN THE SENATE OF THE UNITED STATES

April 29, 2026

Mr. Scott of South Carolina (for himself and Mr. Warner) introduced the 
following bill; which was read twice and referred to the Committee on 
Finance

_______________________________________________________________________

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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Clinical Trial Modernization Act''.

SEC. 2. DEFINITION.

For purposes of this Act, the term ``underrepresented population'' 
has the meaning given such term by the National Institutes of Health 
for purposes of the Toolkit for 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 ENROLLMENT BY 
UNDERREPRESENTED POPULATIONS.

(a) In General.--The Secretary may issue grants to and enter into 
contracts with entities to support community education, outreach, and 
recruitment activities for clinical trials with respect to devices and 
drugs, including vaccines, for diseases or conditions that have a 
disproportionate impact on underrepresented populations. Such 
activities may include--
(1) working with community clinical trial sites, including 
community health centers, academic health centers, sites in 
rural communities, and other facilities;
(2) training health care personnel, including potential 
clinical trial investigators, with a focus on significantly 
increasing the number of underrepresented populations of health 
care personnel who are clinical trial investigators at the 
community sites for ongoing clinical trials;
(3) engaging community stakeholders to encourage 
participation in clinical trials, especially in 
underrepresented populations; and
(4) fostering partnerships with community-based 
organizations serving underrepresented populations, 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 training 
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 2027 and 2028 such sums as may be 
necessary to carry out this section.

SEC. 4. ENCOURAGEMENT OF CLINICAL TRIAL PARTICIPATION BY 
UNDERREPRESENTED POPULATIONS THROUGH PAYMENT OF STUDY 
PARTICIPANT CLINICAL TRIAL EXPENSES AND PROVISION OF 
DIGITAL HEALTH TECHNOLOGIES.

(a) In General.--Section 1128A(i)(6)(F) of the Social Security Act 
(42 U.S.C. 1320a-7a(i)(6)(F)) is amended by striking `` under 
regulations);'' and inserting the following: ``under regulations, 
including--
``(i) remuneration offered or transferred 
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
``(ii) the free provision to an individual 
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 
technologies are necessary for 
participation in such trial;''.
(b) Conforming Amendment to the Anti-Kickback Statute.--Section 
1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a-7b(b)(3)) is 
amended--
(1) by striking ``and'' at the end of subparagraph (K);
(2) by striking the period at the end of subparagraph (L) 
and inserting ``; and'';
(3) by aligning the left margin of each of subparagraphs 
(J) and (K) with the left margin of subparagraph (I); and
(4) by inserting after subparagraph (L) the following new 
subparagraphs:
``(M) any remuneration offered or transferred 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
``(N) the free provision to an individual of 
digital health technologies where--
``(i) the use of the digital health 
technologies 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.

SEC. 5. ENCOURAGEMENT OF CLINICAL TRIAL ACCESSIBILITY THROUGH SUPPORT 
OF CLINICAL TRIAL COST-SHARING.

The payment of patient cost-sharing obligations associated 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 device 
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 services 
provided in the trial is consistent with all applicable 
coverage rules by any Federal health care programs providing 
coverage and reimbursement for beneficiaries participating in 
the trial as study subjects, including but not limited to, any 
existing trial qualification requirements imposed by the 
Centers for Medicare & Medicaid Services for Medicare coverage 
of the trial.
(2) The proposed arrangement for the payment of patient 
cost-sharing obligations is a reasonable means of facilitating 
enrollment of an underrepresented set of subjects or reducing 
the likelihood of attrition in the trial by removing a 
potential financial barrier to participation in the trial.
(3) Any sponsor payments of participating patient cost-
sharing obligations must be available throughout the entirety 
of the clinical trial.
(4) Any sponsor payments of participating patient cost-
sharing obligations are not contingent on the future use or 
purchase of any product or service.
(5) Any sponsor payments of participating patient 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-sharing 
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 patient cost-
sharing obligations will cease upon the patient'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 following elements to 
protect against improper increased 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 subsidies will 
not be advertised, but may be disclosed as required or 
permitted by law in the informed consent forms, 
protocol, or other documentation associated with the 
study.
(B) Participating Federal health care program 
beneficiaries must satisfy formal, objective, 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 protocol for the study and to 
be subject to oversight and monitoring by an 
institutional review board or other similar body 
providing independent oversight for the trial.
(D) Total enrollment for the trial is capped.

SEC. 6. EXCLUSION FROM GROSS INCOME FOR REMUNERATION PROVIDED BY 
SPONSORS OF APPROVED CLINICAL TRIALS TO PARTICIPANTS.

(a) In General.--Part III of subchapter B of chapter 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 PARTICIPANTS.

``(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.''.
(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 protections 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 statute, 
regulation, or any form of guidance, that may apply to any practice or 
arrangement encouraging participation in or accessibility of clinical 
trials.
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