Grassley Presses Administration on EpiPen, Dilaudid, Prilosec Misclassifications

WASHINGTON – Sen. Chuck Grassley is pressing the Centers for Medicare and Medicaid Services for answers on whether it sought to recoup tax dollars overpaid for EpiPens from drug maker Mylan and added a new request, for two additional drugs reportedly misclassified under the Medicaid Drug Rebate Program, Dilaudid and Prilosec.  
 
“I have previously written you asking what steps the Obama Administration took to hold Mylan accountable for misclassifying the EpiPen – you have failed to respond thus far,” Grassley wrote to Acting Administrator Andy Slavitt.  “My request was in response to CMS declaring that ‘on multiple occasions, [CMS] 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.’ 
 
“Given this public pronouncement, Congress and the American public have a right to know what additional steps, if any, CMS took to hold Mylan and other companies accountable and CMS has an obligation to answer.  These misclassifications could have cost the taxpayers and states hundreds of millions of dollars. The Obama Administration’s silence on these issues is unwarranted and irresponsible.”
 
Grassley wrote that in addition to EpiPen, Dilaudid and Prilosec also reportedly were identified as misclassified in 2009 and so cost the taxpayers more than they were required to pay.   Since those drugs, like EpiPen, are popular, the overpayments could be significant.  He asked for an accounting of what, if any, steps the Administration took to determine the amount of overpayment, recoup a refund or impose penalties on the drug makers, Purdue and AstraZeneca.  Grassley asked for a response by Jan. 18. 
 
Earlier, the Department of Health and Human Services Office of Inspector General confirmed it will conduct three new reviews of the Medicaid Drug Rebate Program at the request of Grassley and fellow senators.
 
Grassley’s latest letter is available here.  His Oct. 3 letter to CMS on the EpiPen misclassification is available here.
 
 

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