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The TG population may have a higher prevalence of risk factors for HCV infection and be less likely to access health services due to stigma

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For alignment with language in the preamble of the CY 2025 PFS proposed rule (89 FR 61977) and the clarification made to 428.302(b)(1) as described above, we have clarified in this final rule at 428.303(b)(1) that CMS will apply a likely to be in shortage rebate reduction to the applicable period in which the request was submitted or the following applicable period, depending on the timing of the submission of the request

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