HHS-OIG Highlights Anti-Fraud Safeguards of Drug Manufacturer’s Free Drug Program for Patients in Financial Need
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 no cost-sharing. The program was offered by a pharmaceutical manufacturer to patients who receive an intravenous drug and meet certain objective eligibility criteria.
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