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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 MAC’s LCD.

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Aberrant methylation of DNA and proteins, which causes alterations in chromatin structure and gene expression, are a common feature of cancer cells