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minimum follow-up period of six months since the beginning of NMR/BTX-A treatment

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At 428.101(b), we proposed to codify the policy established in section 30.2 of the revised Medicare Part D Drug Inflation Rebate Guidance for determining the applicable threshold and excluding from the definition of a Part D rebatable drug, and thus Part D drug inflation rebates, drugs and biologicals for which the average annual total cost under Part D for such applicable period per individual who uses such drug or biological product is below that applicable threshold

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