CMS Sets Date for Medicare Drug Price Negotiation Final Guidance for July

The US Centers for Medicare and Medicaid Services (CMS) will aim to release the final draft guidance on the upcoming Medicare drug pricing negotiations instantiated by the passage of the Inflation Reduction Act. The draft guidance was released last month and is currently open for comments. The agency, according to its administrator Chiquita Brooks-Lasure, has already begun talks with manufacturers.

According to Ahmed Aboulenein, “In drafting the guidance, Brooks-LaSure said the agency was deliberately focused on closing potential loopholes companies could use to get around being selected for negotiations. The draft guidance showed the agency would include spending on all formulations or dosage forms of a drug, even if it received a separate U.S. Food and Drug Administration (FDA) approval for a different use.”

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(Source: Reuters, April 12^th, 2023)