S4440-119

What This Bill Does

The Clinical Trial Modernization Act defines underrepresented population by reference to the National Institutes of Health Toolkit for Patient-Focused Therapy Development, as published on April 1, 2024, plus populations recognized by the Food and Drug Administration. It then uses that definition to reduce practical and legal barriers to clinical-trial participation by underrepresented patients.

The bill authorizes the Secretary to issue grants and contracts for community education, outreach, and recruitment activities for clinical trials involving drugs and devices, including vaccines, for diseases or conditions that disproportionately affect underrepresented populations. Supported activities include work with community clinical trial sites, community health centers, academic health centers, rural sites, and other facilities; training health care personnel and potential clinical trial investigators; increasing the number of underrepresented health care personnel who serve as investigators; engaging community stakeholders; and partnering with community-based organizations, employee unions, and frontline health care workers. The Secretary must prioritize multilingual education, recruitment, and training materials and outreach in traditionally underrepresented communities such as tribal areas. The bill authorizes such sums as necessary for fiscal years 2027 and 2028 for these grants and contracts.

The bill amends Social Security Act civil monetary penalty and anti-kickback provisions so certain clinical-trial supports are protected. Clinical trial participants may receive remuneration for trial-related expenses other than patient cost-sharing obligations, including travel, transportation, and meals, if the support is available to all study participants and facilitates inclusion of relevant demographic, socioeconomic, geographic, and rural populations. Participants may also receive free digital health technologies when the technologies are necessary for trial participation and intended to facilitate participation by underrepresented patient populations. Those amendments apply to remuneration provided on or after enactment.

The bill also protects payments by drug or device manufacturers or their agents for patient cost-sharing obligations tied to clinical trial participation, including trials that require FDA diversity action plans. Those payments are not treated as violations of the Social Security Act civil monetary penalty law, the federal anti-kickback statute, or the False Claims Act if the statutory conditions are met. The trial must follow federal health-care-program coverage rules, the payment arrangement must reasonably facilitate enrollment of underrepresented subjects or reduce attrition by removing a financial barrier, payments must be available throughout the trial, payments may not depend on future product use or purchase, payments may not exceed federal-program cost-sharing obligations, participants must agree not to accept other cost-sharing assistance, and assistance must stop when the patient leaves the trial or the trial ends. The arrangement also must avoid advertising the subsidy, use objective enrollment criteria, require informed consent, require written investigator agreements with protocol compliance and independent oversight, and cap total enrollment.

Finally, the bill creates Internal Revenue Code section 139J. Gross income would not include clinical-trial participation payments from an approved clinical trial, up to $2,000 per taxable year. This tax exclusion applies to taxable years beginning after enactment. A rule of construction says sections 4 and 5 do not limit or narrow other liability protections under the Social Security Act, False Claims Act, statutes, regulations, or guidance that may apply to practices or arrangements encouraging clinical-trial participation or accessibility.

Who Benefits and How

Underrepresented clinical-trial participants benefit from grants that support community outreach, multilingual materials, and recruitment in tribal areas, rural communities, community health centers, and academic health centers. Rural trial participants benefit because travel, transportation, meal expenses, and needed digital health technologies can be provided without triggering specified fraud-and-abuse laws when the conditions are met. Patients facing cost-sharing obligations benefit because drug and device manufacturers may pay those obligations under a protected arrangement that removes a financial barrier to trial enrollment or reduces attrition. Clinical-trial sponsors, drug manufacturers, device manufacturers, community trial sites, and digital health technology vendors benefit from clearer authority to support participation. Individual clinical-trial participants benefit from an income-tax exclusion for up to $2,000 of approved trial payments each taxable year.

Who Bears the Burden and How

The Secretary must administer grant and contract awards and prioritize multilingual and underrepresented-community outreach. Clinical-trial sponsors, drug manufacturers, device manufacturers, and their agents must comply with conditions on expense payments, digital health technology provision, cost-sharing support, non-advertising, objective enrollment criteria, informed consent, investigator agreements, independent oversight, enrollment caps, and termination of assistance when a patient leaves the trial or the trial ends. Clinical trial participants receiving cost-sharing assistance must agree not to accept other financial assistance for those same cost-sharing obligations. Federal health care programs and CMS must apply the new liability protections within existing coverage and reimbursement rules. The Internal Revenue Service must implement and administer the $2,000 exclusion, and federal revenue is reduced by the excluded income.

Key Provisions

• Defines underrepresented population using NIH Toolkit and FDA recognized populations.
• Authorizes grants and contracts for clinical-trial education, outreach, recruitment, investigator training, community partnerships, multilingual materials, and outreach in tribal areas.
• Protects clinical-trial participants who receive travel, transportation, meal, and similar trial-expense support without triggering specified civil monetary penalty or anti-kickback provisions when conditions are met.
• Protects free digital health technologies when necessary for trial participation by underrepresented patient populations.
• Protects manufacturer payment of patient cost-sharing obligations from specified civil monetary penalty, anti-kickback, and False Claims Act liability when coverage, enrollment, consent, oversight, and anti-abuse conditions are met.
• Creates a tax exclusion for up to $2,000 per taxable year of approved clinical-trial participant payments from gross income.
• Protects other statutory, regulatory, or guidance-based liability protections for arrangements that encourage clinical-trial participation or accessibility.