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To do so, in accordance with the statute, for each applicable calendar quarter, CMS proposes to identify drugs and biological products with Part B average total allowed charges for a year per individual that uses such a drug or biological product below the applicable threshold

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As the first step in the reporting process, as proposed in proposed 428.401(b) and consistent with section 50 of the revised Medicare Part D Drug Inflation Rebate Guidance, CMS would provide each manufacturer of a Part D rebatable drug with the preliminary rebate amount through a Preliminary Rebate Report at least 1 month prior to the issuance of the Rebate Report specified in proposed 428.401(c) for an applicable period (that is, approximately 8 months after the end of the applicable period unless otherwise specified)