HHS-OIG Highlights Anti-Fraud Safeguards of Refund, Discount Program Offered By Pharma to Alleviate Drug's Cost
Highlights
The HHS-OIG released a favorable opinion regarding refunds and discounts offered to a treatment center for a drug manufactured by the corporation offering the assistance
The discounts offered under the proposed arrangement satisfy the “discount” safe harbor to the Anti-Kickback Statute (AKS)
The proposed arrangement included factors, the agency said, that limited risk under the AKS and the civil monetary penalty laws (CMP)
The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) recently released OIG Advisory Opinion 24-04, a favorable opinion regarding the federal Anti-Kickback Statute (AKS) and civil monetary penalty laws (CMP) against beneficiary inducements as applied to a refund program and discount program. The program was offered by an affiliate of a drug manufacturer to a treatment center that administers a one-time, potentially curative drug for what was termed an ultra-rare pediatric medical condition.
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