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These factors collectively suggest that the conclusions, while robust, should be interpreted with caution in clinical decision-making

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However, CMS finalized the regulatory text specifying the time periods for regular reconciliation cycles at § 427.501(d) with text that provides CMS with operational flexibility as to the exact date the report with the reconciled rebate amount will be provided to each manufacturer of a Part B rebatable drug by including the word “within” prior to the specified date