Sponsors (2)
The bill reduces financial barriers and preserves public-benefit eligibility for clinical-trial participants—boosting enrollment and access to research—at the cost of some federal and state fiscal exposure and added administrative complexity and integrity risks.
Low-income and other clinical-trial participants will not lose or have reduced means-tested benefits because trial payments are excluded when determining eligibility, preserving access to assistance and care.
Patients (especially low-income and uninsured) will face fewer financial barriers to enrolling in clinical trials because payments and reimbursements are not treated as taxable income, likely increasing trial participation and expanding access to experimental treatments.
Individuals participating in approved clinical trials will keep more of their compensation and have reimbursed trial-related expenses (travel, lodging, childcare) treated tax-free, increasing their take-home pay and reducing out-of-pocket costs.
If the bill's definitions or the IRC term are ambiguous or interpreted broadly, participants and payers could face disputes with the IRS, increased compliance costs, audit risk for individuals, and program-integrity/fraud exposure for benefit administrators and hospitals.
State and local means-tested program administrators may face higher program costs if more trial payments are excluded from income/resource counts, increasing pressures on state budgets and potentially shifting costs to local taxpayers.
Federal taxpayers could experience modest revenue losses or indirectly bear higher costs if excluding trial payments reduces taxable revenue or raises federally funded benefit outlays without offsetting savings.
Based on analysis of 2 sections of legislative text.
Excludes payments and reimbursements for participation in approved clinical trials from taxable income and from counting as income/resources for federally funded benefits.
Official title: To amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants, and for other purposes.
Introduced June 26, 2025 by Mike Kelly · Last progress June 26, 2025
Excludes compensation and reimbursements paid to individuals (and their dependents) for participation in federally recognized "approved clinical trials" from federal gross income. Also requires that such qualified clinical trial payments not be counted as income or resources when determining eligibility for federal programs or state/local programs that receive federal funds.