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Manent JB, Demarque M, Jorquera I, Pellegrino C, Ben-Ari Y, Aniksztejn L, Represa A

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We proposed at 428.302(b)(1) to provide a time-limited standard reduction of 75 percent in the total rebate amount for a generic Part D rebatable drug or biosimilar when CMS determines there is a severe supply chain disruption during the applicable period, such as that caused by a natural disaster or other unique or unexpected event