Lexology October 6, 2023
The Biden administration announced this week that all 10 manufacturers whose drugs have been selected for “negotiation” under the Inflation Reduction Act’s Medicare Part D Drug Price Negotiation Program have executed the agreement to participate in negotiations for the selected drugs. The administration is proceeding with implementation of the Drug Price Negotiation Program amidst numerous pending federal lawsuits challenging the constitutionality of the program and the legality of the Centers for Medicare & Medicaid Services’ (CMS) approach to implementation.
CMS will now enter into “negotiations” with these participating manufacturers through August 1, 2024. According to CMS Guidance, the “negotiation period” will include various meetings with the manufacturers as well as listening sessions with patients, consumer groups, and other interested parties...
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