DOJ Files False Claims Act Complaint Against Regeneron, Alleging Fraudulent Eylea Drug Pricing

As we previously reported, the U.S. Department of Justice (“DOJ”) filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts regarding Regeneron’s sales of Eylea in 2020.  The DOJ recently announced that it has filed another False Claims Act complaint against Regeneron Pharmaceuticals, alleging that “Regeneron fraudulently inflated Medicare reimbursement rates” for its eye therapy product Eylea (aflibercept) by “knowingly submitting false average sales price reports to the Centers for Medicare and Medicaid Services that excluded certain price concessions.”

According to the intervenor complaint, “[f]rom 2012 to 2021, Regeneron’s credit card fee reimbursements for Eylea purchases exceeded $250 million to just one of its several distributors. Regeneron paid those fees so that doctors and retina practices that purchased Eylea could use credit cards at no additional cost and obtain hundreds of millions of dollars in ‘cash back’ rewards and other credit card benefits on their Eylea purchases. Regeneron’s subsidy payments were price concessions that Regeneron should have included in its price reporting to CMS for Eylea. Regeneron knowingly excluded the credit card processing fee payments in its price reports, however, thereby falsely inflating Medicare reimbursements for Eylea and giving Regeneron an unfair competitive advantage. Regeneron’s conduct, and the resulting harm to Medicare, is ongoing.”

The government is seeking, among other things, treble statutory damages and a disgorgement of ill-gotten profits.