Senator Grassley Seeks Further Info on Mylan’s EpiPenBy
Senator Chuck Grassley (R-Iowa), chairman of the US Senate Judiciary Committee, is pressing for further information regarding the classification of Mylan’s EpiPen under the Centers for Medicare and Medicaid Services.
Sen. Grassley released information from the Department of Health and Human Services Office of Inspector General of an estimate of $1.27 billion in overpayments from 2006 through 2016 based on the classification of the product under the Medicaid Drug Rebate Program. Sen. Grassley is seeking further information from Mylan and the Centers for Medicare and Medicaid Services for documentation on why EpiPen was misclassified under the Medicaid Drug Rebate Program.
In October 2016, Mylan agreed to a $465-million settlement with the US Department of Justice and other government agencies to resolve questions about whether EpiPen Auto-Injector was properly classified for the Medicaid Drug Rebate Program with the Centers for Medicaid and Medicare Services. The terms of the settlement did not provide for any finding of wrongdoing on the part of Mylan.
The settlement terms provided for resolution of all potential rebate liability claims by federal and state governments as to whether the product should have been classified as an innovator drug for the Centers for Medicaid and Medicare Services’ purposes and subject to a higher rebate formula. In August 2016, Mylan came under US government attention regarding pricing of EpiPen Auto-Injector and has since adjusted pricing and related product entries, including the entry of an authorized generic for the product.