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April 12, 2024
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DOJ files complaint against Regeneron for alleged false drug pricing reports

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Key takeaways:

  • The Department of Justice alleged that Regeneron manipulated Medicare’s drug pricing process.
  • Regeneron said that the allegations are without merit.

The U.S. Department of Justice filed a complaint under the False Claims Act against Regeneron Pharmaceuticals, according to a press release.

The company is alleged to have “fraudulently inflated Medicare reimbursement rates for Eylea by submitting false average sales price reports to the Centers for Medicare and Medicaid Services.”

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The U.S. Department of Justice filed a complaint under the False Claims Act against Regeneron Pharmaceuticals, according to a press release.

According to the release, Regeneron did not report price concessions, which took the form of credit card processing fees that were paid to specialty drug distributors. The company allegedly paid these fees “so that distributors would accept credit cards for Eylea purchases while still charging a lower, cash price for the drug, and so that Regeneron’s customers — typically retina and ophthalmic practices — could receive credit card benefits for their purchases, such as ‘cash back’ and other credit card rewards.”

“Regeneron greatly inflated the costs of its drug to Medicare over many years and enhanced its revenues,” Joshua S. Levy, acting U.S. Attorney for the District of Massachusetts, said in the release. “Falsely reported average sales prices cost the Medicare system hundreds of millions of dollars, and we will make every effort to prevent such practices.”

Regeneron said in a statement to Healio that the allegations are “without merit” and that the company will defend itself in court.

“The complaint, which follows a civil investigative demand from the U.S. Department of Justice in June 2021, and which the company previously disclosed, relates to the company’s lawful reimbursement of costs incurred by our specialty distributors,” Regeneron said. “The government’s complaint demonstrates a fundamental misunderstanding of drug price reporting standards. Regeneron has fully cooperated with the government’s investigation.”