Key Takeaways

• The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the Anti-Kickback Statute (AKS).
  
• This decision aligns with the Sixth and Eighth Circuits while rejecting the Third Circuit's more lenient standard, which allowed claims to be deemed false even if an AKS violation had no actual impact on provider decision-making.
  
• The ruling raises the bar for FCA enforcement, making it harder for the government and whistleblowers to establish liability for claims that merely followed an alleged kickback.

The First Circuit's Ruling in Regeneron

In Regeneron, the government alleged that the company violated the AKS by covering patient copayments through a charitable foundation, thereby inducing physicians to prescribe Eylea. The government argued that any Medicare claims for Eylea that followed these payments were false under the FCA, regardless of whether the alleged kickback actually influenced a physician's prescribing decision.

Regeneron countered that a claim is only "false" under the FCA if an AKS violation actually caused the submission of the claim – meaning the claim would not have been submitted but for the kickback. The First Circuit agreed with Regeneron, ruling that the phrase "resulting from" in the FCA's 2010 amendment to the AKS imposes a but-for causation requirement.

The court relied on Supreme Court precedent in ...

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