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Mylan Communications With CMS To Get Outside Review Under EpiPen Settlement

 
• By Brenda Sandburg

Corporate integrity agreement requires Mylan to have an independent body review its drug classifications and US best price determinations; settlement resolves claims Mylan misclassified EpiPen to underpay rebates. Sanofi acted as whistleblower in case.

Mylan NV has agreed to have an independent review organization monitor the prices it sets for government reimbursed products. The provision for the oversight body is included in a corporate integrity agreement the company entered as part of a settlement with the Department of Justice to resolve claims it misclassified EpiPen (epinephrine) as a generic drug to underpay Medicaid drug rebates.

Under the settlement agreement, announced on Aug. 17, Mylan will pay $465m to resolve False Claims Act complaints brought by Sanofi-Aventis US LLC and Ven-A-Care in which the government intervened. The federal government is to receive $231

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