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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. Each phase-in policy allows eligible manufacturers to build up in a stepwise manner to the 10% and 20% applicable discounts by 2029 and 2031, respectively. 1395w-114c(e). Final Guidance at 52-53.