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CMS proposes in proposed 428.401 that the multi-step reporting process for providing rebate information to a manufacturer would include: (1) an initial report, which CMS proposes to entitle the Preliminary Rebate Report in proposed 428.401(b) and (2) a second report, which CMS proposes to entitle the Rebate Report in proposed 428.401(c)

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CMS welcomes comments on the method by which CMS could collect such information, the timing of the potential collection and deadlines, and whether information reported by manufacturers should be taken into account for purposes of compiling the Rebate Reports for a Part D rebatable drug or instead only be included in the reconciliation processes specified in proposed 428.401(d) and described later in this proposed rule

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