Mylan will reclassify EpiPen as a brand-name drug consistent with the Medicaid statute and regulations, the Centers for Medicare and Medicaid Services (CMS) announced Thursday.
In the agreement between CMS and Mylan regarding the classification of EpiPen, in addition per the agreement, Mylan agreed to use the correct reference price of the third 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.
“Mylan’s agreement with CMS to correctly classify EpiPen is a huge win for Medicaid beneficiaries and American taxpayers,” CMS Administrator Seema Verma said. “Medicaid will no longer be overcharged for EpiPen, protecting access for Medicaid beneficiaries who rely on this lifesaving drug while saving hundreds of millions of dollars. This announcement puts drug manufacturers on notice that CMS remains vigilant in our duty to protect the integrity of the Medicaid program.”