Bass, Berry & Sims attorney Jennifer Michael authored an article for the Health Law Connections magazine published by the American Health Law Association (AHLA) examining the future of patient assistance programs (PAPs) in light of recent case law, guidance from the Office of Inspector General (OIG), and other enforcement actions.
PAPs initially were established to help curb drug costs for financially needy patients. However, as Jennifer points out, “Although financially needy Medicare Part D beneficiaries may still receive assistance from patient assistance foundations, recent case law and OIG advisory opinions have made clear that pharmaceutical manufacturers that directly subsidize Medicare Part D beneficiaries’ copayments for the manufacturers’ own products run the risk of violating the federal Anti-Kickback Statute.”
After OIG informed Pfizer that its proposed direct copayment assistance program could violate the Anti-Kickback Statute (AKS), Pfizer sued the agency, claiming that its program does not violate the AKS because the program is not administered with a corrupt intent. After losing at the district and appellate court levels, Pfizer has asked the Supreme Court to weigh in on the matter and overturn the earlier courts’ “staggeringly overbroad” interpretation of the AKS. In the article, Jennifer writes, “If granted, Pfizer’s petition for certiorari to the U.S. Supreme Court will clarify whether manufacturers can provide copayment assistance directly to Medicare Part D beneficiaries prescribed the manufacturers’ own products—a move that could undermine an important safeguard against rising drug prices.”
The full article, “Pfizer v. OIG, the Inflation Reduction Act, and the Future of Patient Assistance Programs,” was published in the December 2022 issue of Health Law Connections magazine and is also available online (subscription to AHLA required). Jennifer has written and provided insight on this topic extensively; more of her insight can be found here.