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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.

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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law Blog

in general (the statute does not indicate that these lists would be mutually exclusive). For drugs approved on or before July 1, 2015, the inflation rebates would be payable beginning 3Q 2023, and for those approved after that date, rebates would be payable beginning with the later of 3Q 2023 or the sixth full calendar quarter after launch.