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Clinical Trials.gov 2016

To calculate the reduced total rebate amount for a Part B rebatable drug, at 427.401(b), we proposed the following formula: Reduced Total Rebate Amount = total rebate amount multiplied by (1 minus applicable percent reduction) multiplied by (percentage of time drug was currently in shortage during the calendar quarter) added to the total rebate amount multiplied by (1 minus percentage of time drug was currently in shortage during the calendar quarter) For the purpose of this formula, for a Part B rebatable drug that is a plasma-derived product, at 427.401(b)(2)(i), we proposed an applicable percent reduction of 75 percent for the first 4 consecutive calendar quarters such Part B rebatable drug is currently in shortage, 50 percent for the second 4 consecutive calendar quarters, and 25 percent for each subsequent calendar quarter

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