U.S. agency says it advised Mylan that EpiPen was misclassified

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EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company are seen in Washington

WASHINGTON (Reuters) – A U.S. health agency said on Wednesday it had “expressly advised” Mylan that the company had misclassified the EpiPen in a way that led to the company paying a lower rebate to states.

The Centers for Medicare and Medicaid Services, part of the U.S. Department of Health and Human Services, said in a statement it has “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.”

Mylan classified the EpiPen with the Medicaid Drug Rebate Program as a non-innovator multiple source drug, which pays a rebate of 13 percent to states, rather than innovator, which pays a rebate of a minimum of 23.1 percent.

(Reporting by Diane Bartz; Editing by David Gregorio)

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