“Incorrect classification” of EpiPen leads to $1 billion bill for US government

pharmafile | October 6, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Cost, Heather Bresch, Misclassification, Mylan, Price hike, classification, epipen, price, scandal 

Mylan’s EpiPen woes show no sign of abating after CMS (Centers for Medicare and Medicaid Services) released figures that show that the US government health plans have spent more than $1 billion on the EpiPen, as part of the Medicaid plan for the poor. This is not news of itself, however, CMS has released a statement stressing that Mylan may have underpaid rebates to the government due to misclassification.

“CMS has, on multiple occasions, provided guidance to the industry and Mylan on the proper classification of drugs and has expressly told Mylan that the product is incorrectly classified,” the agency said.

US Senator Amy Globuchar of Minnesota, and other lawmakers contend that Mylan underpaid rebates to state Medicaid programs by misclassifying EpiPen as a generic instead of a branded drug. The Medicaid rebate for a generic is 13 percent compared with a minimum 23.1 percent for a branded drug.

Mylan released a statement, saying only that “It would be premature to comment further on this issue until the CMS process has concluded”.

This news comes as the investigation into Mylan’s practises intensifies as public interest grows in the revelation that are occurring on a frequent basis. Beginning initially with the price hike scandal, which was followed by the promise a half-price EpiPen within weeks, only for this promise to be retracted.

Ben Hargreaves

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