(c) Identification of the Payment Amount Benchmark Period for a Part D Rebatable Drug No Longer Considered To Be a Selected Drug In proposed 428.202(c)(5), CMS proposes to codify policies described in section 40.2.2 of the revised Medicare Part D Drug Inflation Rebate Guidance relating to the identification of the payment amount benchmark period for a selected drug (as defined in section 1192(c) of the Act) with respect to a price applicability period (as defined in section 1191(b)(2) of the Act) in the case such Part D rebatable drug is no longer considered to be a selected drug
However, because Leqembi is subject to the NCD for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease under coverage with evidence development (CED), [241] and because Leqembi was initially marketed and sold under accelerated approval, Leqembi coverage under Part B required the product to be furnished in a randomized controlled trial (RCT) conducted under an investigational new drug (IND) application
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2004 Surgeon General's ReportThe Health Consequences of Smoking (PDF)
Drug Alcohol Depend
To determine the percentage of time a Part D rebatable drug was currently in shortage during the applicable period, as proposed in 428.301(b)(3), CMS would count the number of days such drug is currently in shortage in an applicable period and divide by the total number of days in that applicable period
