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After considering the comments, we are persuaded by feedback provided by interested parties that the second alternative also supports our stated goal in the proposed rule: to codify a clear payment methodology for situations in which manufacturer ASP data is zero or negative, while accurately and fairly paying for these drugs and biosimilars

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Another commenter asked that CMS align coverage policies with the USPSTF's 2023 recommendation for the Prevention of Acquisition of HIV: Preexposure Prophylaxis, and asked CMS to create a safe harbor for PrEP products in the first year following transition from Part D to Part B

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