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As explained in the CY 2025 PFS proposed rule (89 FR 61965), after further consideration of this policy and the data that are available to CMS in the Medicaid Drug Programs system, we do not believe that calculating the benchmark period manufacturer price using the 3 or 4 quarters, as applicable, of AMP reported in the payment amount benchmark period described at 428.202(c)(1) or (2) of the earliest NDC-9 of the Part D rebatable drug is operationally feasible at this time

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Pros and Cons Advantages: Potential for supporting tissue regeneration in experimental models 5