What does Preamble of Clinical Trial Modernization Act do?

This bill is formally titled 'A bill to modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes.'

What does SHORT TITLE. of Clinical Trial Modernization Act do?

This bill is formally titled Clinical Trial Modernization Act

What does DEFINITION. of Clinical Trial Modernization Act do?

This section defines the term 'underrepresented population' for the purposes of this Act. The definition of 'underrepresented population' incorporates the meaning given by the National Institutes of Health (NIH) in the Toolkit for Patient-Focused Therapy Development. The NIH Toolkit was published on April 1, 2024. The definition also includes populations recognized by the Food and Drug Administration (FDA).

What does GRANTS TO ENCOURAGE CLINICAL TRIAL ENROLLMENT BY of Clinical Trial Modernization Act do?

The Secretary may issue grants for community education and outreach for clinical trials Grants support recruitment activities for underrepresented populations Entities may work with community sites, train health care personnel, and engage stakeholders Priority is given to entities developing multilingual materials or outreach in underrepresented communities Funding is authorized for fiscal years 2027 and 2028

What does ENCOURAGEMENT OF CLINICAL TRIAL PARTICIPATION BY of Clinical Trial Modernization Act do?

This section amends Section 1128A(i)(6)(F) and 1128B(b)(3) of the Social Security Act. The amendments allow remuneration to be offered to clinical trial participants for expenses such as travel, transportation, and meal expenses, provided it's available to all participants and facilitates inclusion of diverse populations. The amendments also permit the free provision of digital health technologies to participants if it facilitates the participation of underrepresented populations and is necessary for participation. These changes are intended to encourage clinical trial participation by underrepresented populations. The amendments clarify that these remunerations and technology provisions are not considered kickbacks under the Anti-Kickback Statute. The changes apply to remuneration provided on or after the date of enactment of this Act.

What does ENCOURAGEMENT OF CLINICAL TRIAL ACCESSIBILITY THROUGH SUPPORT of Clinical Trial Modernization Act do?

This section addresses clinical trial accessibility by clarifying that cost-sharing payments made by drug or device manufacturers are not violations of specific federal laws. These payments are permissible under the Social Security Act and the False Claims Act, provided certain requirements are met. The clinical trial and its coverage must align with applicable federal health care program rules, including those of the Centers for Medicare & Medicaid Services. The arrangement must reasonably facilitate enrollment of underrepresented subjects or reduce attrition by removing financial barriers. Sponsor payments must be available throughout the trial, not contingent on future product use, and not exceed patient cost-sharing obligations. Patients receiving cost-sharing assistance cannot accept other financial assistance for those obligations. Payments cease upon patient disenrollment or trial conclusion. Measures are required to prevent increased costs and inappropriate utilization of services, including limiting advertising of subsidies, requiring enrollment criteria, and establishing oversight by investigators and institutional review boards. Total enrollment for the trial is capped.

What does EXCLUSION FROM GROSS INCOME FOR REMUNERATION PROVIDED BY of Clinical Trial Modernization Act do?

This section amends the Internal Revenue Code of 1986 to exclude certain payments from gross income. The exclusion applies to payments received by individuals for participating in approved clinical trials. The amount excluded from gross income is limited to $2,000 per taxable year.

What does RULE OF CONSTRUCTION. of Clinical Trial Modernization Act do?

This section establishes a rule of construction regarding sections 4 and 5 of the Act. It clarifies that sections 4 and 5 should not be interpreted in a way that limits existing liability protections. These existing protections are found in sections 1128A and 1128B of the Social Security Act and sections 3729 through 3733 of title 31, United States Code. The protections apply to practices or arrangements encouraging participation in or accessibility of clinical trials.

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Clinical Trial Modernization Act

Last updated: 4/29/2026 · Introduced: 4/29/2026

Author: Tim Scott (R-SC)

TL;DR (AI)

This bill authorizes grants to community organizations for outreach and education aimed at increasing clinical trial enrollment among underrepresented populations, with priority given to multilingual materials and outreach in those communities.
The bill amends existing law to allow clinical trial participants, particularly those from underrepresented populations, to receive remuneration for expenses like travel and access to digital health technologies without these being considered illegal kickbacks.
The bill clarifies that financial assistance from drug or device manufacturers to cover patient cost-sharing in clinical trials is permissible, provided it facilitates enrollment of underrepresented subjects and meets specific requirements to prevent abuse.

119th Congressin committeeHR. 3521(In Committee)Official page

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Includes provisions on preamble, short title., and 6 more.

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