In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for” causation. As we previously reported, the Sixth Circuit and the Eighth Circuit have also held that the stricter “but-for” causation standard applies to AKS-based FCA claims.

The FCA imposes civil liability on anyone who “knowingly presents, or causes to be presented, a false or fraudulent claim for payment” by the government. 31 U.S.C. § 3729(a)(1)(A). One common theory of FCA liability is based on violations of the AKS. Under a 2010 amendment to the AKS, a claim for payment by a federal health care program that “includes items or services resulting from a violation” of the AKS constitutes a “false or fraudulent claim” under the FCA. 42 U.S.C. § 1320a-7b(g). The issue in Regeneron was thus what standard of causation is required to satisfy the “resulting from” language in the AKS.

The causation issue in Regeneron arose from a drug manufacturer’s contributions to a copayment assistance program. Regeneron manufactures a drug called Eylea, which is used to treat an eye disease common in elderly people (neovascular (wet) age-related macular degeneration, known as “wet AMD”). Eylea is covered by Medicare. The government alleged that Regeneron funded an independent charitable foundation (the Chronic Disease Fund) which, in turn, subsidized patient...

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