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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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Latest CMS Rule Impacts Wide Range of Health Care Stakeholders with Changes for COVID-19 Emergency and Beyond


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On May 8, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published an interim final rule with comment (“IFC”) in the Federal Register. The rule includes a wide range of modifications to CMS regulations governing payment rates, coverage of telehealth services, conditions of participation, scope of practice, calculation of medical education payments, and value-based payment programs – to name a few. 

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