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What Awaits in the First Year of Medicare Drug Price Negotiations? CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process

On March 15, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued an initial guidance memorandum (“Memorandum”) describing how it proposes to implement the Inflation Reduction Act Medicare Drug Price Negotiation Program (“Negotiation Program”) for the Initial Price Applicability Year of 2026 (the “Initial Year”). In the Memorandum, CMS provides further guidance regarding (i) how it intends to select the Medicare Part D drugs and biologics for which it will negotiate a maximum fair price (“MFP”) for the Initial Year (the “Selected Drugs”), (ii) the data and evidence that manufacturers will be required to submit that will inform CMS’s initial price proposals, (iii) the structure of the negotiation process, and (iv) implementation and enforcement of the MFP.

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CMS Announces Delays and Extensions for Pay for Performance Value-Based Programs


Time to Read: 1 minutes Practices: Health Care

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On June 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced timeline changes for several CMS Innovation Center Models in response to the COVID-19 public health emergency, extending some models while delaying the start of others. The changes, first announced in a blog post authored by CMS leadership, are outlined in a flexibilities table made available by CMS. We have prepared a table below providing a brief description of each model and indicating the timeline changes. Links to related Ropes & Gray alerts are provided as well for additional information. If you have any questions, please don’t hesitate to contact one of the authors or your usual Ropes & Gray advisor.

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