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The incidence is unknown, and it did not occur during the drugs clinical trials

(1) For each applicable calendar quarter beginning on or after January 1, 2023, the reduced total rebate amount for a Part B rebatable drug currently in shortage will be calculated using the following formula: Equation 1 to Paragraph (b)(1) Reduced Total Rebate Amount = the total rebate amount multiplied by (1 minus applicable percent reduction) multiplied by (percentage of time drug was currently in shortage during the applicable calendar quarter) added to the total rebate amount multiplied by (1 minus percentage of time drug was currently in shortage during the applicable calendar quarter) (2) For purposes of paragraph (b)(1) of this section, the applicable percent reduction is: (i) For a Part B rebatable drug that is a plasma-derived product: (A) 75 percent for the first 4 consecutive applicable calendar quarters such drug is currently in shortage