S. 4440 — Clinical Trial Modernization Act

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

This section authorizes the Secretary to award grants and enter into contracts supporting community education, outreach, and recruitment activities for clinical trials of drugs, devices, and vaccines targeting diseases or conditions with disproportionate effects on underrepresented populations. Eligible activities include partnerships with community sites such as health centers and rural facilities, training of health care personnel with a focus on increasing underrepresented clinical trial investigators, stakeholder engagement, and collaborations with community-based organizations. The Secretary must give priority to entities developing materials in multiple languages or conducting outreach in traditionally underrepresented communities, including tribal areas. This section authorizes such sums as may be necessary to be appropriated for fiscal years 2027 and 2028.

This section expands exceptions under the civil monetary penalties law and anti-kickback statute to exclude from the definition of remuneration (1) payments to clinical trial participants for travel, transportation, meal, and similar expenses incurred during the trial (other than patient cost-sharing obligations), provided such payments are available to all participants and facilitate inclusion of patients from all relevant demographic, socioeconomic, and geographic populations, including rural communities; and (2) free digital health technologies necessary to enable participation by underrepresented patient populations. The amendments apply to remuneration provided on or after the date of enactment.

This section permits drug and device manufacturers or their agents to pay patient cost-sharing obligations for participants in clinical trials (as defined in section 2709(d) of the Public Health Service Act) or trials requiring a diversity action plan under sections 505(z) or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act without violating the Civil Monetary Penalties Law, the Anti-Kickback Statute, or the False Claims Act, provided eight conditions are met. These conditions require consistency with federal health care program coverage rules, use of payments solely to facilitate enrollment of underrepresented subjects or reduce attrition, availability of payments throughout the trial without contingency on future product purchases, caps on total enrollment, and safeguards against advertising subsidies or improper utilization of reimbursed items and services.

This section establishes an exclusion from gross income for payments received by individuals participating in approved clinical trials (as defined in section 2709 of the Public Health Service Act), limited to $2,000 per taxable year. The exclusion applies to taxable years beginning after the date of enactment.

This section provides a rule of construction clarifying that nothing in sections 4 or 5 of the Act limits or narrows existing protections from liability under sections 1128A and 1128B of the Social Security Act or sections 3729 through 3733 of title 31, United States Code, for any practice or arrangement encouraging participation in or accessibility of clinical trials.