Lexology November 10, 2025
McDermott Will & Schulte LLP

340B covered entities should carefully review the approved 340B rebate models and the 2026 Medicare Physician Fee Schedule (MPFS) Final Rule provisions on new CMS processes for identifying Medicare Part D claims for 340B drugs.

While the current scope may seem limited or not applicable to certain 340B covered entities, now is the most important time to evaluate the implications of these programs if expanded to all 340B drugs and all 340B covered entities in order to ensure that the concerns of 340B covered entities are appropriately addressed.

340B Rebate Models

As a reminder, although the only drugs currently subject to the 340B rebate models are those that will be subject to the Medicare Part D negotiated prices, the 340B...

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