HHS-OIG Declines Sanctions on Medical Device Manufacturer for Medicare Cost-Sharing Subsidies in Clinical Trial
Highlights
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 agency noted that the cost-sharing appears to be a reasonable means to facilitate enrollment of socioeconomically diverse participants in the clinical trial
The agency determined overutilization and inappropriate utilization was unlikely since the trial was limited, reasonably structured with appropriate safeguards, and distinguishable from problematic seeding arrangements
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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