Mylan N.V. said its subsidiaries, Mylan Inc. and Mylan Specialty L.P., have signed an agreement with the U.S. Department of Justice and two relators finalizing the Medicaid drug rebate settlement that the company announced on Oct. 7, 2016, for $465 million.
The settlement resolves claims relating to the classification of EpiPen Auto-Injector and EpiPen Jr Auto-Injector for purposes of the Medicaid Drug Rebate Program. The big question was whether the EpiPen products were properly classified with the Centers for Medicare and Medicaid Services as a non-innovator drug under the definition in the Medicaid Rebate statute and subject to the formula that is used to calculate rebates to Medicaid for such drugs. EpiPen Auto-Injector has been classified with CMS as a non-innovator drug since before Mylan acquired the product in 2007 based on longstanding written guidance from the federal government.
According to a company release, the settlement provides for resolution of all potential Medicaid rebate liability claims by the federal government, as well as potential claims by certain hospitals and other covered entities that participate in the 340B Drug Pricing Program. In connection with the settlement, Mylan also has entered into a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services. The settlement does not contain an admission or finding of wrongdoing. Mylan will reclassify EpiPen Auto-Injector for purposes of the Medicaid Drug Rebate Program and pay the rebate applicable to innovator products effective as of April 1, 2017.