129 Groups Urge OIG to Create Anti-Kickback Safe Harbor for Clinical Trial Participant Expenses
The American Cancer Society Cancer Action Network and 128 other advocacy and professional groups submitted a comment letter to HHS OIG on August 24, 2026, requesting a new safe harbor under the federal anti-kickback statute. The proposed safe harbor would allow clinical trial sponsors to cover participants' travel, lodging, and other expenses without exposure to fraud and abuse liability. The comment period timing suggests OIG is considering rulemaking on this issue. For Medicaid providers participating in clinical trials, this matters because current anti-kickback constraints limit their ability to cover beneficiary costs, potentially reducing trial participation among Medicaid populations who face the greatest financial barriers to access.
Medicaid providers and health plans conducting or facilitating clinical trials face legal uncertainty when covering patient costs that could improve trial access for beneficiaries who disproportionately face financial barriers to participation.
Managed Care
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