December 12,2016

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Aaron Fobes, Julia Lawless (202)224-4515

Hatch, Upton, Murphy and Pitts Press CMS for Answers on EpiPen Rebates

Letter Follows Up on Past Request for Oversight of Medicaid Drug Rebate Program

WASHINGTON, DC – Bicameral leaders sent a letter on Friday to Centers for Medicare and Medicaid Services (CMS) Acting Administrator Andy Slavitt asking questions about the misclassification of the EpiPen Auto-Injector and EpiPen Jr Auto-Injector by Mylan Pharmaceuticals for purposes of the Medicaid Drug Rebate Program. The letter was signed by House Energy and Commerce Committee Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), Subcommittee on Health Chairman Joseph Pitts (R-PA), and Senate Finance Committee Chairman Orrin Hatch (R-UT).

In September, Energy and Commerce Committee leaders and Senate Finance Republicans separately requested that the Department of Health and Human Services and the Office of Inspector General examine CMS’ oversight of the Medicaid Drug Rebate Program. In responses to the Energy and Commerce Committee and Finance Committee this month, the HHS OIG informed the committees that they will audit and evaluate CMS’s apparently lax oversight of the program.

“The Energy and Commerce Committee first raised concerns with EpiPen’s classification under the Medicaid Drug Rebate Program in July 2015,” wrote Upton, Murphy, and Hatch. “In February 2016, CMS…reported the agency was ‘currently looking into the issue’, but did not answer the Committee’s specific questions or provide a timeframe for resolving concerns. It is notable that CMS failed at that time to provide any specific details regarding its general oversight of manufacturers’ self-reported classification of drugs for purposes of the Medicaid Drug Rebate Program.”

The leaders continued, “Both Committees are concerned that CMS knew that EpiPen was misclassified for years and failed to take remedial action. As a result, on September 12, 2016, the Energy and Commerce Committee wrote to the Department of Health and Human Services Office of Inspector General (OIG) to request an investigation into CMS’ oversight of the Medicaid Rebate Program. This request was echoed by the Senate Committee on Finance in a September 20, 2016, letter to the OIG. Given the seriousness of this violation and its bearing on the integrity of the Medicaid Drug Rebate Program, the Committee also requests that CMS address these issues immediately by providing the following additional information and documents to the Committees by December 20, 2016.”

Click HERE to read a copy of the letter.