Regeneron Pharmaceuticals — Drug Pricing and Medicare Reimbursement
DOJ Files False Claims Act Complaint Against Regeneron Over Eylea Pricing
Source: U.S. Department of Justice
TL;DR: DOJ Files False Claims Act Complaint Against Regeneron Over Eylea Pricing This case resulted in a Ongoing Litigation resolution and demonstrates the impact of whistleblower protections in recovering funds from fraud.
Summary
DOJ filed a False Claims Act complaint against Regeneron Pharmaceuticals alleging that Regeneron inflated Medicare reimbursement rates for Eylea by submitting false average sales price (ASP) reports to CMS that excluded certain price concessions. DOJ specifically alleged the unreported concessions included credit card processing fees Regeneron paid to specialty drug distributors, which DOJ characterized as benefiting customers and affecting Medicare's pricing calculations. DOJ stated the suit originated as a qui tam action and that the United States intervened.
Our Take
Drug-pricing FCA cases often look "technical" from the outside, but internally they usually hinge on deliberate accounting choices and how the company defined (or avoided defining) a concession. If you're close to pricing operations, the key evidence is typically in policies, finance memos, distributor agreements, and communications about how fees, rebates, or other transfers should be treated for reporting. When teams debate whether something "counts" as a concession, that debate—and who overruled whom—often becomes central.
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Notice
The summaries above are based on publicly available information released by the U.S. Department of Justice and are provided for informational purposes only. They do not constitute legal advice, investigative findings, or allegations by Disclosure Strategy. Our commentary reflects general, experience-based observations about how False Claims Act matters commonly arise and is not a statement about any party's liability.