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CMS adopted this provision to clarify CMS' intended policy, as highlighted by examples in the CY 2025 PFS proposed rule, that while CMS will generally apply the shortage reduction starting with the first applicable calendar quarter that a Part B drug or biological product is described as currently in shortage, CMS acknowledges that for a Part B drug or biological that has been granted a rebate reduction for a severe supply chain disruption, it would be appropriate to delay the start of the applicable percent reduction for being in shortage until after the conclusion of the severe supply chain disruption reduction if the shortage continues

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Future studies should take these considerations into account to advance understanding in this field