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The Pulse of the Pharmaceutical Industry

U.S. watchdog told Medicare, Medicaid that EpiPen was misclassified in 2009: senator

Written by: | | Dated: Tuesday, November 8th, 2016

EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016.

REUTERS/Jim Bourg/File Photo




By Sarah N. Lynch | WASHINGTON


The internal watchdog at the U.S. Department of Health and Human Services warned the office tasked with administering federal health insurance programs that Mylan NV’s EpiPen was improperly classified as a generic drug in 2009, Senator Charles Grassley said Tuesday.

In a press release, Grassley’s office said the HHS Inspector General confirmed in discussions with Senate aides that the watchdog office notified the Centers for Medicare and Medicaid Services about the problematic classification, which was highlighted in a report.

Mylan said last month it intends to pay $465 million to settle with the U.S. Justice Department over charges it misclassified the EpiPen as a generic instead of a branded drug, thereby underpaying rebates owed to state and federal Medicaid programs.

The Justice Department has previously declined to comment on the purported settlement, which will be the subject of a Nov. 30 hearing before the Senate Judiciary Committee, which Grassley chairs.

“The taxpayers deserve answers on what happened between 2009 and now,” Grassley said in a statement.

“It appears the EpiPen was misclassified for years, and CMS was notified of the problem. If no one did anything about the misclassification, why not?”

Grassley added that he has invited HHS Inspector General Daniel Levinson to testify, as well as officials from the Justice Department, the Centers and Mylan.

Representatives of Mylan, the Justice Department and the Centers did not immediately respond to requests for comment.

Mylan has come under fire in recent months for hiking the price of the lifesaving allergy treatment to more than $600 for a package of two in less than a decade.

Earlier this month, West Virginia’s attorney general sent a letter to the Justice Department urging the government to reject the purported $465 million settlement, calling it “woefully deficient.”




Source: Reuters Health

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