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This approach (or the alternative approaches described below), if finalized, would replace the policy in the revised Medicare Part D Drug Inflation Rebate Guidance to treat Part D rebatable drugs first approved or licensed on or before October 1, 2021, that were not marketed until after that date in the same manner as subsequently approved drugs

As the first step in the reporting process, as proposed in proposed 427.501(b) and consistent with section 60 of the revised Medicare Part B Drug Inflation Rebate Guidance, CMS would provide the manufacturer of a Part B rebatable drug with the preliminary rebate amount through a Preliminary Rebate Report that is provided to each manufacturer of a Part B rebatable drug at least 1 month prior to the issuance of the Rebate Report specified in proposed 427.501(c) for an applicable calendar quarter (that is, at least 5 months after the end of the applicable calendar quarter)

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