In 2010, as part of the Affordable Care Act, Congress resolved a highly litigated issue about whether a violation of the Anti-Kickback Statute (AKS) can serve as a basis for liability under the federal False Claims Act (FCA). Specifically, Congress amended the AKS to state that a “claim that includes items or services resulting from a violation of [the AKS] constitutes a false or fraudulent claim for purposes of the [FCA].”
This amendment, however, did not end the debate over the relationship between the AKS and the FCA. Over the last several years, multiple courts have been called upon to interpret what it means for a claim to “result from” a violation of the AKS. Courts across the country are split on the correct standard. On February 18, 2025, the U.S. Court of Appeals for the First Circuit joined the Sixth and Eight Circuits in adopting a stricter “but-for” standard of causation—while the Third Circuit has previously declared that the government must merely prove a causal connection between an illegal kickback and a claim being submitted for reimbursement.
Blog Editors
Recent Updates
- Legislative Push for FDA Preemptive Authority Over Dietary Supplement Regulation
- GUARD and GLOBE Pricing Models Could Test Manufacturer Rebates for Medicare Part B and D Drugs
- FDA’s Office of Dietary Supplement Programs Signals Key Enforcement and Policy Priorities for the Year Ahead
- OIG Issues Guidance, Request for Information on DTC Programs
- OIG Greenlights Cost-Sharing Waiver for Commercially Insured Patients