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(ii) If the conditions of paragraph (b)(3)(i) of this section are satisfied, the deadline for reporting and returning the initially identified overpayment and related overpayments that arise from the same or similar cause or reason as the initially identified overpayment will remain suspended until the earlier of: (A) The date that the investigation of related overpayments has concluded and the aggregate amount of the initially identified overpayments and related overpayments is calculated

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For example, if CMS grants a severe supply chain disruption rebate reduction request for a generic Part D rebatable drug or biosimilar that was submitted on November 15, 2024, and that generic Part D rebatable drug or biosimilar is currently in shortage from September 15, 2025, until May 15, 2026, CMS would apply a 75 percent reduction in the total rebate amount for the duration of the applicable period for which the severe supply chain disruption rebate reduction request was granted (that is, October 1, 2024, to September 30, 2025), and then would apply the shortages reduction as proposed in 428.301, beginning with a reduction of 25 percent for a biosimilar or 75 percent for a generic Part D rebatable drug or plasma-derived product that is a biosimilar for the applicable period beginning October 1, 2025

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