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Because drugs and biologicals on the FDA shortage lists are maintained at the NDC-10 level, and Part D drug inflation rebates are calculated at the NDC-9 level, CMS proposes in 428.301(c) that if any NDC-10 for a Part D rebatable drug is currently in shortage, CMS would apply the rebate reduction to the entire Part D rebatable drug at the NDC-9 level

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This approach aligns claims and payment data run-out with the run-out used during a regular reconciliation cycle

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