Lexology March 21, 2025
Barnes & Thornburg LLP

Highlights

The HHS-OIG released a favorable opinion regarding free drugs offered to patients in financial need for a drug manufactured by the pharmaceutical company offering the assistance

The assistance offered under the proposed arrangement did not satisfy a safe harbor to the Anti-Kickback Statute (AKS)

The agency said the proposed arrangement included factors that limited concerns under the AKS and the civil monetary penalty laws

The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) recently released OIG Advisory Opinion 25-01, a favorable opinion regarding the federal Anti-Kickback Statute (AKS) and civil monetary penalty laws (CMP) against beneficiary inducements as applied to a financial assistance program that would provide an intravenous drug at no cost or with...

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Topics: Biotechnology, Govt Agencies, HHS, OIG, Pharma, Pharma / Biotech
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