H.R. 3521 — Clinical Trial Modernization Act

This section defines the term “underrepresented population” for purposes of this Act as having the meaning given by the National Institutes of Health for its Toolkit for Patient-Focused Therapy Development (published April 1, 2024), in addition to populations recognized by the Food and Drug Administration.

This section authorizes the Secretary of Health and Human Services to award grants and contracts to entities for community education, outreach, and recruitment activities to increase enrollment of underrepresented populations in clinical trials for devices, drugs, and vaccines addressing diseases or conditions that disproportionately affect such populations. Activities may include (1) working with community clinical trial sites such as community health centers, academic health centers, and rural facilities; (2) training health care personnel to increase the number of investigators from underrepresented populations at community sites; (3) engaging community stakeholders to encourage participation; and (4) fostering partnerships with community-based organizations serving underrepresented populations, including employee unions and frontline health care workers. In awarding grants and contracts, the Secretary must prioritize entities that develop materials in multiple languages or conduct outreach in traditionally underrepresented communities such as tribal areas. The section authorizes appropriations for FY2025 and FY2026 of such sums as necessary.

This section revises an exception to the civil monetary penalties law's prohibition on beneficiary inducements (SSA §1128A(i)(6)(F)) and adds conforming safe harbors to the Anti-Kickback Statute (SSA §1128B(b)(3)) for two forms of remuneration provided during clinical trials (as defined in PHS Act §2709(d)). The permitted remuneration includes (1) payments for trial-related expenses other than patient cost-sharing—such as travel, transportation, and meals—made available to all participants to facilitate inclusion of patients from diverse demographic, socioeconomic, and geographic populations, including rural communities; and (2) free provision of digital health technologies that are necessary for participation by underrepresented populations. The amendments apply to remuneration provided on or after the date of enactment.

This section provides that payments by drug or device manufacturers or their agents to cover patient cost-sharing obligations for participants in qualifying clinical trials are not violations of the Civil Monetary Penalties Law (42 U.S.C. 1320a-7a), anti-kickback statute (42 U.S.C. 1320a-7b), or False Claims Act (31 U.S.C. 3729-3733), subject to specified requirements. Qualifying clinical trials are those defined in section 2709(d) of the Public Health Service Act or requiring a diversity action plan under sections 505(z) or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act. The requirements are that (1) the trial and coverage comply with all applicable Federal health care program rules, including Centers for Medicare & Medicaid Services qualification criteria; (2) the payments reasonably facilitate enrollment of underrepresented subjects or reduce attrition by removing financial barriers; (3) payments are available throughout the trial; (4) payments are not contingent on future product or service use; (5) payments do not exceed the patient's cost-sharing obligations under Federal health care programs; (6) patients agree not to accept other financial assistance for cost-sharing; (7) payments cease upon patient disenrollment or trial conclusion; and (8) safeguards are included prohibiting advertising of subsidies (except as required or permitted in study documents), requiring objective enrollment criteria and informed consent, mandating investigator agreements with institutional review board oversight, and capping total enrollment.

This section excludes from gross income payments received by an individual for participation in an approved clinical trial (i.e., as defined in section 2709(d) of the Public Health Service Act), up to $2,000 per taxable year. The exclusion applies to taxable years beginning after the date of enactment.

This section provides that nothing in sections 4 or 5 of the Act limits or narrows other existing protections from liability under the Civil Monetary Penalties Law (42 U.S.C. 1320a-7a), Anti-Kickback Statute (42 U.S.C. 1320a-7b), or False Claims Act (31 U.S.C. 3729-3733)—whether in statute, regulation, or guidance—for any practice or arrangement encouraging participation in or accessibility of clinical trials.