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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3521 Introduced in House (IH)]
<DOC>
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 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.
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 2025 and 2026 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.
<all>
Introduced in House
Introduced in House
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.
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.
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