Health Affairs January 19, 2024
Currently, there are nine lawsuits across the country alleging a variety of constitutional and statutory legal claims against the Medicare Drug Price Negotiation Program (negotiation program) enacted under the Inflation Reduction Act (IRA). To date, constitutional claims include allegations that the negotiation program violates the First Amendment, the Fifth Amendment’s Due Process clause and Takings Clause, the Eighth Amendment’s Excessive Fines Clause, the Nondelegation doctrine, and the enumerated powers doctrine.
In addition to the constitutional challenges, three drug companies—Boehringer Ingelheim, AstraZeneca, and Novo Nordisk—allege that guidance issued by the Centers for Medicare and Medicaid Services (CMS)—the division of the Department of Health and Human Services (HHS) entrusted with implementing the negotiation program—violates the Administrative Procedure Act (APA). The APA both...
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