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Grassley to Centers for Medicare and Medicaid Services on EpiPen Misclassification: "Provide Us With Records"

January 25, 2017
Toledo Chronicle, Tama News-Herald

WASHINGTON - Sen. Chuck Grassley reiterated his request for answers on whether the Centers for Medicare and Medicaid Services (CMS) took any action to recover the tax dollars overpaid because of EpiPen's misclassification under the Medicaid Drug Rebate Program. Last week, Grassley criticized the agency for a "lackluster and very disappointing response" on the issue.

"It is unfortunate that I have to write CMS a second time to get answers. CMS has publicly stated 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 the EpiPen for purposes of the Medicaid Drug Rebate Program was incorrect,' " Grassley wrote to Acting Administrator Patrick Conway. "CMS took the same position in an October 5, 2016, letter to the Committee. Despite the public pronouncements, CMS has failed to provide any evidence of its communications with Mylan and has failed to describe the steps it took to hold Mylan accountable. The American people and Congress deserve answers, and CMS is obligated to provide them."

Grassley added a hand-written note: "I think you know what we want and you didn't provide. We need records. Provide us with records. If this is not plain, just talk with my staff and they will be very specific."

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Senator Chuck Grassley

Grassley's latest letter is available here. His October 3, 2016, letter is available here. His comment last week follows.

Jan. 19, 2017

Sen. Chuck Grassley has pressed the Centers for Medicare and Medicaid Services (CMS), the Justice Department, and the drug company Mylan to explain the misclassification of EpiPens under the Medicaid Drug Rebate Program and whether the government took any action to recover the tax dollars overpaid because of the misclassification. CMS just responded to Grassley's inquiry. Grassley made the following comment on the response.

"It's a lackluster and very disappointing response. CMS won't provide any details about whether it took any specific action on the EpiPen misclassification. Instead, CMS seems to suggest it lacks the authority to compel drug companies to classify their drugs properly. If that's the case, why didn't Congress hear this before now? Is the intent to do little or nothing and then when confronted, blame the inaction on a supposed lack of authority? Didn't CMS have the authority and the obligation to report clear violations of the law to the Justice Department and if so, has it done so in the case of EpiPens and other misclassified drugs? CMS is trying to dodge responsibility for a problem that likely cost the taxpayers hundreds of millions of dollars and damaged Medicaid program integrity. This won't stand. The attitude that wasted tax money doesn't matter or that holding companies to their legal obligations are someone else's problem is irresponsible. I plan to pursue fixes to this problem. I'm hopeful the Trump Administration will be more interested in answering to the taxpayers than the Obama Administration was on this problem."



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