HHS-OIG Highlights Anti-Fraud Safeguards for Patient Assistance Programs Backed Mainly by Drug Manufacturers
Highlights
The HHS-OIG released a favorable opinion regarding rare-disease patient assistance programs that receive funding from pharmaceutical manufacturers
The agency determined that appropriate safeguards limit the risk under the Anti-Kickback Statute
It is important to note that the HHS-OIG analyzed the arrangement under the current Medicare Part D cost-sharing structure (prior to new 2025 out-of-pocket caps), and limited the effective dates of the opinion until Jan. 1, 2027
On April 8, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) released Advisory Opinion No. 24-02, a favorable opinion regarding patient assistance programs (PAPs) independently managed by a 501(c)(3) non-profit, but funded primarily by pharmaceutical manufacturers. The opinion is time-limited and only in effect until Jan. 1, 2027, to account for future legal changes which could affect the opinion’s analysis.
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