My­lan to pay $465 mn over EpiPen over­charges to Med­i­caid

Kuwait Times - - HEALTH & SCIENCE -

My­lan will pay $465 mil­lion to re­solve ac­cu­sa­tions from some reg­u­la­tors that it over­billed the fed­eral Med­i­caid pro­gram for the EpiPen al­lergy med­i­ca­tion, the drug­maker an­nounced Fri­day.

The set­tle­ment with the De­part­ment of Jus­tice and some other reg­u­la­tors re­solves ques­tions about My­lan’s clas­si­fi­ca­tion of EpiPen as a generic drug, the drug­maker said. My­lan said it did not ad­mit fault in the agree­ment.

Fed­eral health care reg­u­la­tors have said the mis­clas­si­fi­ca­tion contributed to a swelling of pay­ments to My­lan, which nearly mo­nop­o­lizes the mar­ket for the al­lergy in­jec­tors, for EpiPen un­der fed­eral health care pro­grams. Had EpiPen been cor­rectly clas­si­fied, My­lan would have been forced to pay higher re­bates to fed­eral and state of­fi­cials, of­fi­cials with the US Cen­ter for Medi­care and Med­i­caid Ser­vices (CMS) have said.

My­lan, which has been un­der strong at­tack from politi­cians and the pub­lic for jack­ing up the price of EpiPens — essen­tial for se­vere al­lergy suf­fer­ers to block lifethreat­en­ing at­tacks-touted the set­tle­ment. “This agree­ment is an­other im­por­tant step in My­lan’s ef­forts to move for­ward and bring res­o­lu­tion to all EpiPen Auto-In­jec­tor re­lated mat­ters,” said My­lan chief ex­ec­u­tive Heather Bresch.

De­spite news of the set­tle­ment, My­lan al­luded to a fresh fed­eral in­ves­ti­ga­tion in an SEC fil­ing, say­ing it had re­ceived a doc­u­ment re­quest Fri­day from en­force­ment of­fi­cials “seek­ing com­mu­ni­ca­tions with the CMS and doc­u­ments con­cern­ing My­lan prod­ucts sold and re­lated to the Med­i­caid Drug Re­bate Pro­gram, and any re­lated com­plaint.”

“My­lan in­tends to fully co­op­er­ate with the SEC’s in­ves­ti­ga­tion,” it added. A CMS of­fi­cial de­clined sub­stan­tive com­ment on the set­tle­ment. “Today, through an SEC fil­ing, My­lan Phar­ma­ceu­ti­cal an­nounced that it has come to an agree­ment in prin­ci­ple with the fed­eral govern­ment over a dis­pute over the mis­clas­si­fi­ca­tion of Epipen in the Med­i­caid Drug Re­bate Pro­gram,” a CMS spokesper­son said.

“We have no fur­ther com­ment at this time.” A Jus­tice De­part­ment spokes­woman de­clined com­ment, adding, “the Jus­tice De­part­ment does not con­firm or deny the ex­is­tence of an in­ves­ti­ga­tion.”

My­lan has been un­der fire since Au­gust over the soar­ing price of the life-sav­ing EpiPen in­jec­tors, for which it faces vir­tu­ally no com­pe­ti­tion in the mar­ket. A pack of two of the de­vices soared to more than $600 from less than $100 in 2007, when My­lan bought the rights to the tech­nol­ogy.

My­lan in Au­gust boosted pa­tient as­sis­tance pro­grams to help de­fray costs for EpiPen, elim­i­nat­ing im­me­di­ate out-of­pocket costs for the unin­sured and un­der­in­sured. Bresch en­dured a bruis­ing hear­ing on Capi­tol Hill last month where she was pressed on swelling com­pen­sa­tion for ex­ec­u­tives at the com­pany that was tied in part to the ris­ing in­come from EpiPen sales.

Bresch de­fended the com­pany’s pric­ing, say­ing some of the higher cost was due to pay­ments to in­sur­ers and oth­ers in the health care in­dus­try. How­ever, the com­pany was forced to back off a claim that a two-pack of EpiPens yielded a profit of just $100 after it emerged that the fig­ure de­ducted for an un­re­al­is­ti­cally high amount of taxes. My­lan shares rose 8.5 per­cent in after-hours trade. — AFP

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