Mylan will refund 340B covered entities a total of $19.3 million for overcharges on the EpiPen as part of its recent settlement agreement with the Department of Justice resolving claims that it misclassified the product as a generic. Mylan will have six months from the date of the settlement agreement, which was finalized August 17, 2017, to calculate the amounts owed to each covered entity plus interest and an additional month to issue the refunds. Each covered entity will receive its pro-rata share of the $19.3 million settlement amount.
Mylan also agreed to pay the federal government $465 million to resolve claims that the manufacturer defrauded the government. The claims were originally brought under the False Claims Act by two whistleblowers, Sanofi and Ven-A-Care. The United States intervened in the case and alleged that Mylan violated the False Claims Act by knowingly misclassifying EpiPen as a generic drug instead of a brand product under the Medicaid Drug Rebate Program, resulting in state Medicaid programs overpaying for EpiPen. Brand name rebates are significantly larger than generic rebates under the Medicaid drug rebate statute, and the Medicaid rebate and 340B discount calculations are closely linked.