HHS-OIG Declines Sanctions on Medical Device Manufacturer for Medicare Cost-Sharing Subsidies in Clinical Trial
HHS-OIG released a favorable opinion on a medical device manufacturer’s cost-sharing plan for billable items and services provided to federal healthcare program beneficiaries participating in a clinical trial
The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) released Advisory Opinion No. 23-11, a favorable opinion regarding a proposed arrangement by which a medical device manufacturer would pay cost-sharing obligations that Medicare beneficiaries participating in a clinical trial would otherwise owe for study-related Medicare-reimbursable items and services, up to a maximum of $2,000 per participant. Despite implicating both the federal Anti-Kickback Statute (AKS) and the beneficiary inducement civil monetary penalty (CMP) rules, the agency on Dec. 27, 2023, determined it would not impose sanctions.
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