Health Law Highlights

Federal Judge Rules Government Must Demonstrate “But-For” Causation for Anti-Kickback Statute Claims

From ArentFox Schiff LLP, by D. Jacques Smith , Randall A. Brater , Michael F. Dearington , Nadia Patel , Heather M. Zimmer:

  • Chief Judge Dennis Saylor of the US District Court for the District of Massachusetts ruled that the federal government must demonstrate but-for causation in order to prove that Regeneron Pharmaceuticals, Inc., the manufacturer of the drug Eylea, submitted false claims resulting from violations of the Anti-Kickback Statute (AKS).
  • The 2010 amendments provide that any Medicare claim that includes items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA.
  • The government urged that the court to adopt the “exposure” theory of causation set forth in United States ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89, 96-98 (3d Cir. 2018) — that once the government has proven an AKS violation occurred, to demonstrate causation, it need only prove a causal link that (1) a patient has been “exposed to an illegal recommendation or referral” and (2) that the provider has submitted a reimbursement claim for that patient.
  • In contrast, Regeneron argued for the stricter “but-for causation standard — that the government must demonstrate that an AKS violation occurred and that the remuneration actually caused the provider to provide different medical treatment and thus caused the false claims.
  • The court held that the adoption by Congress of the ‘resulting from’ language in the AKS statute required a finding that the appropriate standard is but-for causation.