119-hr3521

[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.
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