Federal Register #HHSIG-2026-0034

RFI: Safe Harbor Regulations for Clinical Trial Remuneration

This opportunity is a Request for Information (RFI) from the Health and Human Services Department, Office of Inspector General (OIG), focused on clinical trial remuneration regulations: - Government Buyer: - Department of Health and Human Services (HHS) - Office of Inspector General (OIG) - Purpose: - Seeking public input on potential changes to safe harbor regulations under the Federal anti-kickback statute - Considering exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries - Scope of Input Requested: - Remuneration for clinical trial participants, including: - Reimbursement for travel, lodging, parking, childcare, and meals - Stipends and compensation for time - Incentives for enrollment and completion of clinical trials - Barriers to providing appropriate compensation - Categories of remuneration that facilitate or hinder participation - Risks of fraud and abuse related to these practices - No OEMs, vendors, or specific products/services are being procured - This is an information-gathering effort to inform future rulemaking, not a procurement action

Description

This request for information seeks public input on potential additions or modifications to the safe harbor regulations under the Federal anti-kickback statute and exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries. The focus is on remuneration provided to individuals participating in clinical trials, including reimbursement for expenses and stipends. The Office of Inspector General is soliciting feedback on barriers to offering appropriate compensation and the categories of remuneration that facilitate or hinder clinical trial participation. Comments are due by August 24, 2026.

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