Predicate

In healthcare fraud enforcement, the term predicate most often refers to an underlying violation of the Anti-Kickback Statute (AKS) that then serves as the legal foundation for a separate False Claims Act (FCA) case. The word itself is not found in the FCA’s core liability provisions. Instead, it describes the relationship between the two statutes: an AKS violation is the “predicate offense” that makes a resulting claim false under the FCA.

Congress cemented this link in 2010 when it amended the AKS to state that a claim “resulting from” a kickback violation automatically constitutes a false or fraudulent claim for FCA purposes. This means whistleblowers do not need to prove a separate, explicit lie on a claim form. They can build an FCA case by establishing the underlying kickback violation first, then showing that claims were submitted in connection with that improper arrangement.

This affects healthcare providers, pharmaceutical manufacturers, and suppliers whose financial relationships with referral sources fall outside AKS safe harbors. For whistleblowers, the predicate framework is central at the pleading and causation stage of an FCA lawsuit. The key intricacy is a persistent circuit split over what “resulting from” actually requires. The Third Circuit accepts a looser standard, requiring only “some connection” between the kickback and a claim. The First, Sixth, and Eighth Circuits demand stricter but-for causation, meaning the whistleblower must show the claim would not have been submitted absent the kickback. This split makes jurisdiction and case theory critical, and it continues to shape how predicate-based FCA claims are litigated.

If a whistleblower fails to establish the underlying Anti-Kickback Statute violation, the False Claims Act case based on that alleged violation cannot survive. The AKS violation is the predicate that makes the submitted claim legally false, so without it the FCA theory collapses. Courts routinely dismiss these cases at the pleading stage when the relator cannot allege the elements of a kickback with particularity, or on summary judgment when the evidence fails to connect the alleged remuneration to a claim. An AKS violation alone does not create FCA liability, but the FCA claim still depends entirely on proving that predicate. The failure is usually fatal, not merely a weakness in the case.

Yes. A relator does not need to prove that every claim was tainted by the kickback. Courts generally require a link between the alleged kickback scheme and the submission of at least one specific claim for reimbursement.

– The Third Circuit holds that it is enough to identify at least one claim that covered a patient who was recommended or referred in violation of the Anti-Kickback Statute
– Under this view, a single identifiable claim can anchor an FCA case, even if the broader scheme involved many more
– This does not lower the pleading standard. The relator must still identify that claim with particularity and connect it to the kickback, not merely allege a scheme in general terms

Courts routinely dismiss cases where the relator fails to identify a single submitted claim tied to the kickback.

The “at least one purpose” rule holds that a defendant violates the Anti-Kickback Statute if just one purpose of the remuneration was to induce referrals, even if legitimate business reasons also existed. The Second Circuit adopted this standard in United States ex rel. Camburn v. Novartis Pharmaceuticals, joining seven other circuits. The rule lowers the threshold for establishing an AKS predicate because relators in those Circuits no longer must prove that an improper inducement was the sole or primary purpose. It also eliminates the need to allege a direct quid pro quo or a cause-and-effect link between the payment and the referral. The relator must still plead the scheme with particularity, but the required inference is far less demanding.

The 2010 ACA amendment, codified at 42 U.S.C. § 1320a-7b(g), provides that a claim “resulting from” an Anti-Kickback Statute violation constitutes a false claim under the False Claims Act. The provision says nothing about what “resulting from” means, which has produced a significant circuit split. The First, Sixth, and Eighth Circuits require but-for causation, meaning the whistleblower must show the claim would not have been submitted absent the kickback. The Third Circuit applies a looser standard requiring only “some connection” between the kickback and a later reimbursement claim. This divide directly affects how rigorously a whistleblower must tie a specific kickback to a specific submitted claim to establish FCA liability.

Because an AKS-predicated FCA claim sounds in fraud, Federal Rule of Civil Procedure 9(b) requires the whistleblower to plead both the predicate kickback and the false claim with particularity.

– The relator must identify the who, what, when, where, and how of the alleged kickback arrangement
– The relator must also connect that arrangement to at least one specific claim submitted for payment
– General allegations of a scheme, without representative details, are routinely dismissed
– Some courts require identification of a representative claim, while others accept a reliable sample

This heightened standard is a common failure point. A well-pleaded predicate must be concrete, not conclusory.

Whether an Anti-Kickback Statute violation can serve as the predicate for a reverse false claim is less settled than its role in traditional FCA liability. The reverse false claim provision targets the knowing concealment or avoidance of an existing obligation to pay the government. An AKS violation by itself typically supports a traditional false claim because claims tainted by kickbacks are deemed false. To anchor a reverse false claim, the relator must instead show that the kickback created a distinct obligation to refund or repay government funds, and that the defendant then knowingly concealed or avoided that obligation. Courts have not uniformly accepted AKS violations as reverse false claim predicates, and the theory remains narrowly applied.

No. The whistleblower does not need to prove the defendant knew the Anti-Kickback Statute existed or understood its technical requirements. To establish the predicate offense, the relator must show the defendant knowingly and willfully offered or paid remuneration to induce referrals, not that the defendant knew the payment violated the AKS. The 2010 ACA amendment reinforced this by making clear that a defendant need not have actual knowledge of the statute or specific intent to violate it. Knowledge of the law is therefore not an element of the predicate offense. The focus stays on whether the defendant knowingly engaged in the prohibited arrangement.