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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
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Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those using diuretics concomitantly and the elderly
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