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After weeks of controversy, the Centers for Medicare and Medicaid Services formally blamed Mylan Pharmaceuticals for misclassifying EpiPen with the Medicaid Drug Rebate Program. Under the program, companies must accurately report and pay a rebate on drugs paid for by Medicaid.

“CMS has, on multiple occasions, provided guidance to the industry and Mylan on the proper classification of drugs and has expressly advised Mylan that their classification of EpiPen for purposes of the Medicaid Drug Rebate program was incorrect,” the agency said in a statement. But CMS declined to say what steps are being taken to correct the misclassification.


The statement followed nagging questions about how Mylan classified the emergency allergy device. The company reported EpiPen as a generic, instead of a brand-name, product. This is a significant distinction, because the classifications are used to determine the size of rebates that companies pay Medicaid. Rebates, which are paid in exchange for having their products covered, are lower for generics.

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