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At 427.402(c)(5) and 428.302(c)(5), we proposed that if a manufacturer believes a severe supply chain disruption continues into a fifth consecutive calendar quarter for a Part B rebatable biosimilar biological product, or a second applicable period for a generic Part D rebatable drug or biosimilar after the start of the natural disaster or other unique or unexpected event, the manufacturer may request an extension of the rebate reduction one time by submitting a rebate reduction extension request and supporting documentation

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