To settle allegations that it overbilled Medicaid for the EpiPen, which has been incorrectly classified as a generic product under the Medicaid health program for the poor and disabled since late 1997, Mylan has agreed to pay a $465 million.
It has been questioned whether Mylan underpaid U.S. government healthcare programs by “misclassifying its EpiPen emergency allergy treatment, which has come under intense scrutiny after a series of drastic price increases,” said Reuters.
The 500 percent price increase since 2007 has brought the EpiPen to the forefront of news and controversy, with a two-pack costing approximately $608.
Reuters explained this new concern with Medicaid as follows: “Lawmakers were trying to determine whether Mylan made more money on EpiPen than warranted from state Medicaid programs by having it classified as a generic product, resulting in much smaller rebates to the government health plans.”
However, the terms of the settlement don’t find wrongdoing on the part of Mylan. According to the press release:
The question in the underlying matter was whether EpiPen Auto-Injector was properly classified with the Centers for Medicaid and Medicare Services (“CMS”) as a non-innovator drug under the applicable definition in the Medicaid Rebate statute and subject to the formula that is used to calculate rebates to Medicaid for such drugs. EpiPen Auto-Injector has been classified with CMS as a non-innovator drug since before Mylan acquired the product in 2007 based on longstanding written guidance from the federal government.
“This agreement is another important step in Mylan’s efforts to move forward and bring resolution to all EpiPen Auto-Injector related matters,” Mylan CEO Heather Bresch said. “The agreement is in addition to the significant steps Mylan has taken in relation to EpiPen Auto-Injector over the past several weeks, including the unprecedented, pending launch of a generic version of EpiPen Auto-Injector and expansion of our patient access programs for this product. Entering into this settlement is the right course of action at this time for the company, its stakeholders and the Medicaid program.”
However, not everyone is thrilled by the settlement.
“This settlement is a shadow of what it should be—lacking real accountability for Mylan’s apparent lawbreaking,” Senator Richard Blumenthal of Connecticut said in a statement. He insists that Congress should investigate whether Mylan violated the law.
“I am glad the Department of Justice pursued this so quickly, since the misclassification was an outrage,” said Sen. Amy Klobuchar, D-Minn., in a statement.
According to a regulatory filing on Friday, thet EpiPen will be classified as a branded drug as of April 1, 2017.
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