The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible Medicare patients who need tafamidis, the only approved drug by the Food & Drug Administration (FDA) to treat a rare heart condition. In 2019, Pfizer sought an advisory opinion from the Department of Health and Human Services (HHS) regarding the subsidy program, and in September 2020, HHS advised Pfizer that the program “plainly would” involve prohibited conduct under the Anti-Kickback Statute (AKS) because it would induce Medicare patients to purchase this medication. Pfizer brought a suit to challenge the determination, which ended with the Supreme Court’s denial of certiorari. The decision has special implications for the pharmaceutical industry and potentially impacts any entity that conducts business with federal health care programs.
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