- Tokyogirl79 [CC BY-SA 4.0 ()]
The settlement resolves allegations that Mylan submitted false statements to the Centers for Medicare and Medicaid Services that wrongfully classified EpiPen as a “non-innovator multiple source” drug rather than an “innovator multiple source” or “single source” drug as established in 1990 by the Medicaid Rebate Statute and Rebate Agreement policies. In addition, Mylan failed to report its lowest price to CMS for EpiPen, which is required of innovator source drugs by the Medicaid Best Price Policy.
Medicaid policy requires pharmaceutical companies like Mylan to sign rebate agreements with the Department of Health and Human Services in order to maintain Medicaid coverage for their drugs. They must also pay rebates to state Medicaid programs for drugs dispensed through the program. The amount of such rebates is dependent on pricing information provided by the manufacturer. The misclassification of EpiPen as a non-innovator source drug, however, enabled Mylan to circumvent the price reporting policy and in turn pay nominal rebates to Medicaid.