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Mar 15 [press release] -- For the first time in history, Medicare will have the ability to negotiate lower prescription drug prices because of the Inflation Reduction Act, President Biden’s historic law which lowers health care and prescription drug costs. Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), issued initial guidance detailing the requirements and parameters—including requests for public comment— on key elements of the new Medicare Drug Price Negotiation Program for 2026, the first year the negotiated prices will apply. Alongside other provisions in the new drug law, the Medicare Drug Price Negotiation Program will strengthen Medicare’s ability to serve people currently in Medicare and for generations to come. . . .

The Biden-Harris Administration has made lowering high prescription drug costs and improving access to innovative therapies a key priority. CMS is releasing its initial guidance for how Medicare intends to use its new authority to effectively negotiate with drug companies for lower prices on selected high-cost drugs. The negotiation process will focus on key questions, including but not limited to the selected drug’s clinical benefit, the extent to which it fulfills an unmet medical need, and its impact on people who rely on Medicare. As a result of negotiation, people with Medicare will have access to innovative, life-saving treatments at costs that will be lower for both them and Medicare. . . .

This initial guidance is one of a number of steps CMS laid out in the Medicare Drug Price Negotiation Program timeline for the first year of negotiation. The initial program guidance details the requirements and procedures for implementing the new Negotiation Program for the first set of negotiations, which will occur during 2023 and 2024 and result in prices effective in 2026. Key dates for implementation include:

-- By September 1, 2023, CMS will publish the first 10 Medicare Part D drugs selected for initial price applicability year 2026 under the Medicare Drug Price Negotiation Program.
-- The negotiated maximum fair prices for these drugs will be published by September 1, 2024 and prices will be in effect starting January 1, 2026.
-- In future years, CMS will select for negotiation up to 15 more Part D drugs for 2027, up to 15 more Part B or Part D drugs for 2028, and up to 20 more Part B or Part D drugs for each year after that, as outlined in the Inflation Reduction Act.

CMS is seeking comment on several key elements in today’s guidance. Comments received by April 14, 2023, will be considered for revised guidance. CMS anticipates issuing revised guidance for the first year of negotiation in Summer 2023.

CMS is committed to collaborating and engaging with the public in the implementation of the Inflation Reduction Act. CMS is working closely with patients and consumers, Medicare Part D plan sponsors and Medicare Advantage organizations, drug companies, hospitals and health care providers, wholesalers, pharmacies, and others.  Public feedback contributes to the success of the Medicare Drug Price Negotiation Program, and this initial guidance is one tool, among many, that CMS will use to ensure interested parties know when and how they can make their voices heard on implementation of this new drug law.

Medicare Drug Price Negotiation Program Initial Guidance: https://www.cms.gov/files/document/medicare-drug-price-negotiation-program-initial-guidance.pdf [91 pages]
Fact sheet: https://www.cms.gov/files/document/fact-sheet-medicare-drug-price-negotiation-program-initial-guidance.pdf
Press release: https://www.cms.gov/newsroom/press-releases/hhs-releases-initial-guidance-historic-medicare-drug-price-negotiation-program-price-applicability

2) Mar 17 [FRN] -- Inflation Reduction Act (IRA) Initial Program Guidance; Comment Request

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' initial guidance for the Medicare Drug Price Negotiation Program for the implementation of the Inflation Reduction Act. Comments must be received by April 14, 2023.
Medicare Drug Price Negotiation webpage: https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation
FRN: https://www.federalregister.gov/d/2023-05411

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