Senators call for DOJ investigation of EpiPen misclassification

Three U.S. senators have asked the Department of Justice to investigate Mylan’s misclassification of EpiPens within state Medicaid programs, while the Centers for Medicare & Medicaid Services says it repeatedly warned the company the drug’s classification was incorrect.

The letter--signed by Sen. Richard Blumenthal (D-Conn.), Sen. Chuck Grassley (R-Iowa) and Sen. Amy Klobuchar (D-Minn.)--calls on Attorney General Loretta Lynch to investigate Mylan’s classification of EpiPens within the Medicaid Drug Rebate Program. The senators note that EpiPen has faced no FDA competitor and Mylan has actively prevented other drug makers from introducing competing products, making it an “innovator drug” under the program’s definition, which requires a higher rebate to Medicaid.

These concerns “suggest that Mylan may have knowingly misclassified EpiPens, potentially in violation of the False Claims Act and other statutes,” the senators wrote. Public backlash and fury from lawmakers over Mylan’s substantial price hike have fueled questions about potential overpayments through the Medicaid Drug Rebate Program.

Hours after the letter was released, Reuters reported that CMS repeatedly warned Mylan about the misclassification. CMS told the news outlet that it had “on multiple occasions, provided guidance to the industry and Mylan on the proper classification of drugs and has expressly advised Mylan that their classification of EpiPen for purposes of the Medicaid Drug Rebate program was incorrect.”

Several weeks ago, Klobuchar indicated the EpiPen misclassification may have cost the state of Minnesota $4.3 million in overpayments in just one year.  A recent report indicated that Medicare Part D spending on EpiPens has jumped more than 1,100 percent in seven years.