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Medicare requires laboratory evidence of deficiency or a confirmed diagnosis such as pernicious anemia, a signed physician order specifying drug name, dose, route, and frequency, an administration record documenting the date, drug, dose, route, site, and administering clinician, and an ICD-10-CM diagnosis code on the claim that traces to a covered indication in the relevant MACs LCD.

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They shut down operations in what became one of the most significant enforcement actions against a grey-market peptide vendor in recent memory

PMID: 246 BockPFriedelWHanischJKarasmannMSchneiderB