Lawmakers voiced concerns this week that the Centers for Medicare and Medicaid Services (CMS) may have known for years that the EpiPen was misclassified under a drug rebate program and failed to act.
U.S. Reps. Fred Upton (R-MI) and Tim Murphy (R-PA), and U.S. Sen. Orrin Hatch (R-UT) sought information about the misclassification of EpiPen Auto-Injector and EpiPen Jr. Auto-Injector under the Medicaid Drug Rebate Program in a letter to acting CMS Administrator Andy Slavitt.
In October, Mylan Pharmaceuticals, the manufacturer of the allergy-reaction injector device, agreed to a $465 million settlement with the U.S. Department of Justice related to the classification of EpiPen as a generic drug rather than a brand drug under the Medicaid Drug Rebate Program. That generic drug classification allowed Mylan to pay lower rebates to Medicaid programs.
Upton, the chairman of the House Energy and Commerce Committee, and Murphy, Oversight and Investigations Subcommittee chairman, first raised concerns about EpiPen’s classification under the Medicaid program in July 2015. In February, CMS replied that it was looking into the issue.
Hatch, the chairman of the Senate Finance Committee, in September led a request for the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to examine CMS oversight of the Medicaid Drug Rebate program.
“Both committees are concerned that CMS knew that EpiPen was misclassified for years and failed to take remedial action,” the letter states.
Given the seriousness of the violation, the committee requested that CMS provide information and documents, noting that CMS failed to provide any specific details regarding general oversight of manufacturers’ self-reported classification of drugs under the Medicaid Drug Rebate Program.