What does Preamble of HR 3521 do?

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

What does SHORT TITLE. of HR 3521 do?

This bill is formally titled the Clinical Trial Modernization Act.

What does DEFINITION. of HR 3521 do?

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

What does GRANTS TO ENCOURAGE CLINICAL TRIAL ENROLLMENT BY of HR 3521 do?

This section authorizes the Secretary to issue grants and contracts to support community education, outreach, and recruitment activities for clinical trials involving drugs, devices, and vaccines. These activities aim to increase participation in clinical trials among underrepresented populations and address diseases with a disproportionate impact on these populations. Eligible activities include working with community clinical trial sites, training health care personnel, engaging community stakeholders, and fostering partnerships with community-based organizations. The Secretary shall prioritize grant and contract awards to entities that develop multilingual materials or conduct outreach in traditionally underrepresented communities, such as tribal areas. Funding for these activities is authorized for fiscal years 2025 and 2026.

What does ENCOURAGEMENT OF CLINICAL TRIAL PARTICIPATION BY of HR 3521 do?

This section amends Section 1128A(i)(6)(F) and 1128B(b)(3) of the Social Security Act. The amendments allow for remuneration to clinical trial participants for expenses, such as travel, transportation, and meal expenses, provided it is available to all participants and facilitates inclusion of diverse populations. The amendments also permit the free provision of digital health technologies to clinical trial participants if those technologies facilitate participation by underrepresented populations and are necessary for participation. These changes are intended to encourage clinical trial participation by underrepresented populations. The amendments clarify that remuneration and digital health technology provision are not considered kickbacks if certain conditions are met. 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 HR 3521 do?

This section addresses clinical trial accessibility by clarifying that cost-sharing payments made by drug or device manufacturers are not violations of specific laws. Specifically, payments are not considered violations of the Civil Monetary Penalties Law, the False Claims Act, or related sections of the Social Security Act. Several requirements must be met for these payments to be permissible, including consistency with applicable coverage rules for federal health care programs. The arrangement must facilitate enrollment of underrepresented subjects or reduce attrition by removing financial barriers. Payments must be available throughout the trial, not contingent on future purchases, and not exceed cost-sharing obligations. Patients receiving assistance must agree not to accept other financial assistance for cost-sharing. Payments cease upon disenrollment or trial conclusion. To prevent improper costs and utilization, the arrangement must include limitations on advertising subsidies, require objective enrollment criteria, and mandate investigator compliance with protocols and oversight by review boards. Total enrollment for the trial is capped.

What does EXCLUSION FROM GROSS INCOME FOR REMUNERATION PROVIDED BY of HR 3521 do?

This section amends the Internal Revenue Code of 1986 to exclude certain remuneration received by individuals participating in approved clinical trials from gross income. The exclusion applies to payments received from sponsors of approved clinical trials, as defined in section 2709 of the Public Health Service Act. The amount excluded from gross income is limited to $2,000 per taxable year. The amendments apply to taxable years beginning after the date of enactment of this Act.

What does RULE OF CONSTRUCTION. of HR 3521 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 or narrows 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, regardless of whether they are in statute, regulation, or guidance.

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Clinical Trial Modernization Act — HR. 3521

Last updated: 5/20/2025 · Introduced: 5/20/2025

Author: Raul Ruiz (D-CA)

TL;DR (AI)

This bill authorizes grants and contracts to support community education and outreach programs aimed at increasing clinical trial participation, particularly among underrepresented populations and for diseases disproportionately affecting them.
The bill amends existing laws to allow clinical trial participants to be reimbursed for expenses like travel and receive digital health technologies to facilitate participation, specifically targeting inclusion of diverse populations, without being considered kickbacks.
The bill clarifies that financial assistance from drug or device manufacturers to reduce cost-sharing for clinical trial participants is permissible, provided certain conditions are met to prevent improper costs and ensure equitable access for underrepresented subjects.

119th Congressin committeeOfficial page

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Other Sections

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

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