First Circuit Embraces More Restrictive View Of False Claims Act Kickback Enforcement Provision

The United States Court of Appeals for the First Circuit's opinion in United States v. Regeneron Pharmaceuticals, Inc. has sharpened the circuit split for demonstrating the effect of a kickback on healthcare decisions under the False Claims Act (FCA). The Regeneron court held that an FCA claim based on an alleged violation of the Anti-Kickback Statute (AKS) requires demonstrating that an alleged unlawful kickback was the "but-for" cause of a submitted claim.

The Regeneron case involves alleged kickbacks relating to an injectable drug called Eylea – a treatment for an ophthalmological condition. The government alleged that the support of charitable foundations, which assist patients with copays for this treatment, constituted unlawful kickbacks.