January 26, 2017—Sen. Chuck Grassley (R-Iowa) is ramping up pressure on the Centers for Medicare and Medicaid Services to hand over documents about Mylan Pharmaceuticals’ misclassification of EpiPen as a generic drug and subsequent underpayment of Medicaid rebates. [ms-protect-content id=”2799″]
“We need records,” the senator wrote to CMS Acting Administrator Patrick Conway on Jan. 19. “Provide us with records. If this is not plain, just talk with my staff and they will be very specific.”
Senator Grassley complained in the letter to Conway about former Acting Administrator’s Andrew Slavitt’s “lackluster and very disappointing” Jan. 18 response to the senator’s previous requests for information about CMS’s communications with Mylan and whether CMS took steps to hold Mylan accountable. Slavitt told Senator Grassley that while CMS believes Mylan misclassified EpiPen and underpaid rebates, CMS lacks statutory authority to compel a manufacturer to reclassify a drug or to issue civil monetary penalties in such a case.
“CMS seems to suggest it lacks the authority to compel drug companies to classify their drugs properly,” Senator Grassley wrote to Conway. “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,” Senator Grassley wrote. “This won’t stand.”
In December, Senate Finance Committee Chairman Orrin Hatch (R-Utah), then House Energy & Commerce Committee Chairman Fred Upton (R-Mich.), then E&C Health Subcommittee Chair Joseph Pitts (R-Pa.), and E&C Oversight Subcommittee Chair Tim Murphy (R-Pa.) wrote separately to Slavitt about CMS’s handling of the EpiPen matter. Among other questions, they asked whether EpiPen’s misclassification as a generic drug for Medicaid rebate purposes caused hospitals and other healthcare providers in the 340B drug discount program to be overcharged. Slavitt’s response has not come to light.
Hospitals and health systems in the 340B program have asked the U.S. Justice Department to investigate whether Mylan overcharged 340B healthcare providers for EpiPens.
Register – 340B Coalition Winter Conference – February 1-3, 2017 – San Francisco, Calif. [/ms-protect-content]