Mylan paying $465M to settle claims it overcharged for EpiPens

Mylan paying $465M to settle claims it overcharged for EpiPens
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Mylan has finalized a $465 million settlement with the federal government over claims the pharmaceutical company overcharged Medicaid for the EpiPen, an emergency allergy treatment.

Thursday’s announcement puts to rest claims that the drugmaker charged Medicaid more money by misclassifying the EpiPen as a generic drug. Brand-name drugs pay higher rebates to the Medicaid program than generic drugs.

“Mylan misclassified its brand name drug, EpiPen, to profit at the expense of the Medicaid program,” Acting U.S. Attorney William D. Weinreb said in a press release.

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“Taxpayers rightly expect companies like Mylan that receive payments from taxpayer-funded programs to scrupulously follow the rules.”

The settlement doesn’t include an admission or finding of wrongdoing, according to a statement from Mylan.

"As we said when we announced the settlement last year, bringing closure to this matter is the right course of action for Mylan and our stakeholders to allow us to move forward,” Mylan CEO Heather Bresch said in a statement. “Over the course of the last year, we have taken significant steps to enhance access to epinephrine auto-injectors.”

The company will reclassify the EpiPen — which can be lifesaving for those with a severe allergy — as a brand-name drug. It will also be subject to five years of intense scrutiny to ensure the company is complying with the Medicaid Drug Rebate program’s rules.

“Mylan’s agreement with [Centers for Medicare & Medicaid Services] to correctly classify EpiPen is a huge win for Medicaid beneficiaries and American taxpayers,” CMS Administrator Seema Verma said in a statement. “Medicaid will no longer be overcharged for EpiPen, protecting access for Medicaid beneficiaries who rely on this lifesaving drug while saving hundreds of millions of dollars.”

In 2014, a competitor, Sanofi, tipped the U.S. Attorney’s Office off to the misclassification. In 2016, Sanofi filed a complaint under the False Claims Act.

Last year, Mylan came under fire for increasing the price of a pack of two EpiPens from about $100 to $600 in less than a decade. Lawmakers used it as another example of skyrocketing drug costs, and Bresch was brought to Capitol Hill in September for an hours-long hearing, where lawmakers grilled the CEO.