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If CMS determines that an NDC-11 is likely to be in shortage, CMS will apply any reduction of the rebate amount as described in paragraphs (b)(1) and (2) of this section to the generic Part D rebatable drug at the NDC-9 level

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We also seek comment on approaches to, and considerations in connection with, balancing the need for accuracy in payment calculations with the need for administrative finality in payment determinations

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Based on the extent to which the included studies adjusted for potential confounders, we categorised them as best-adjusted and others