August 17, 2017—The U.S. Justice Department, CMS, and EpiPen manufacturer Mylan announced today that Mylan has reached a $465 million settlement with the government to resolve claims it knowingly misclassified EpiPen as a generic drug to avoid paying Medicaid drug rebates.
Mylan said the settlement provides for “potential claims by certain hospitals and other covered entities that participate in the 340B Drug Pricing Program.” There were no further details.
CMS said “Mylan will reclassify EpiPen as a brand name drug consistent with the Medicaid statute and regulations. In addition, Mylan has agreed to use the correct reference price of the 3rd quarter of 1990 for the purpose of calculating inflationary payment rebates under the Medicaid Drug Rebate (MDR) program, saving the Medicaid program hundreds of millions of dollars. These changes will be effective retroactive to April 1, 2017.”