Eleventh Circuit Clarifies the Anti-Kickback Statute’s Scienter Requirement in United States v. Chun

On August 18, 2026, the U.S. Court of Appeals for the Eleventh Circuit issued its opinion in United States v. Chun, No. 22-14192, affirming the convictions and sentences of two defendants for violations of the federal Anti-Kickback Statute (AKS), 42 U.S. Code Section 1320a-7b(b). In doing so, the court addressed what the government must prove regarding a defendant’s knowledge that items or services at issue are connected to a federal healthcare program. The decision adopts the Fifth Circuit’s standard from United States v. Shah, 95 F.4th 328 (2024), holding that the government need only show that the defendant “knowingly agreed to accept remuneration for referring patients that could be federally insured,”¹ a standard that, while requiring proof of knowledge of potential federal payment, sets a notably low evidentiary bar. The decision raises significant implications for healthcare providers, life sciences companies, and others subject to the AKS. This decision helps define the broad contours of the AKS and highlights the risks for any healthcare or life sciences company that knows some of its products or services may be paid for by any federal healthcare program.

Factual and Procedural Background

The Chun prosecution arose from the broader federal investigation into Insys Therapeutics Inc. (Insys), a pharmaceutical company whose founder and several executives were previously convicted in the U.S. District Court for the District of Massachusetts “for conspiring to bribe physicians to prescribe Subsys, a fentanyl-laced spray medication”² that was approved by the U.S. Food and Drug Administration for the “treatment of breakthrough cancer pain.”³ The convictions were affirmed by the First Circuit in United States v. Simon, 12 F.4th 1 (2021).

In Chun, defendant Steven Chun was a physician specializing in pain medicine and enrolled in Medicare as a provider. Defendant Daniel Tondre was an Insys sales representative whose territory included Chun’s medical practice. The government alleged that Insys paid Chun substantial honoraria through a speaker program designed to educate local physicians about Subsys in exchange for Chun’s agreement to prescribe significant volumes of Subsys. Insys’ former Vice President of Sales Alec Burlakoff testified that the speaker programs were vehicles for transferring cash to high-prescribing physicians he referred to as “whales” and that the arrangement was explicitly conditioned on prescription volume.⁴ The programs allegedly “were poorly attended,” often lacking any genuine educational component, and sign-in sheets frequently contained forged signatures.⁵ When the programs concluded “in 2015, Chun had received honoraria totaling $278,900.”⁶

A federal grand jury in the U.S. District Court for the Middle District of Florida returned a superseding indictment charging Chun and Tondre, and following a jury trial in May 2022, Chun and Tondre were ultimately convicted on charges of conspiracy to violate the AKS and substantive AKS violations. The district court sentenced Chun to 42 months’ imprisonment and Tondre to 48 months’ imprisonment, both representing downward variances from the applicable Guidelines ranges.⁷ Chun and Tondre each appealed both the district court’s denial of their motions for judgments of acquittal and their respective sentences. The Eleventh Circuit affirmed each of the district court’s decisions.

Key Development From the Eleventh Circuit’s Opinion

The AKS “Knowingly” Element Applies to the Federal Healthcare Program Requirement, but the Bar Is Low

The most significant aspect of the Chun decision is the court’s holding on what the government must prove regarding the AKS’s federal healthcare program element. The AKS “prohibits a practitioner from ‘knowingly’ accepting remuneration in exchange for [referrals of] ‘any item or service for which payment may be made in whole or in part under a Federal health care program.’ 42 U.S.C. § 1320a-7b(b)(1).”⁸ Prior to Chun, the Eleventh Circuit had never specifically addressed “what the [g]overnment must show to establish this element,”⁹ particularly as it relates to the requirement that referrals be made in exchange for payment under a federal healthcare program. In United States v. Ruan, the Eleventh Circuit had suggested that the federal healthcare program reference was merely jurisdictional (i.e., not an element as to which the government must prove knowledge or intent), but the U.S. Supreme Court vacated Ruan on other grounds, leaving the issue unsettled.¹⁰

The Chun court adopted the Fifth Circuit’s reasoning in United States v. Shah, 95 F.4th 328 (2024), which held that the government need only show that the defendant “knowingly agreed to accept remuneration for referring patients that could be federally insured.”¹¹ The court offered two reasons for this reading. First, the statute requires only that “payment may be made ... under a Federal health care program,” and the word “may” signals that liability attaches whenever there is a possibility of federal payment, a reading the court found sensible “given the nature of most medical practices, where Medicare constitutes a portion, but not the entirety, of the patients’ insurance coverage.”¹² Second, this interpretation is consistent with the AKS’s own proviso that “a person need not have actual knowledge of this section or specific intent to commit a violation of this section.”¹³

Applying this standard, the court held that the government’s “evidence that Chun had participated in the Medicare program, and, therefore, that he had Medicare patients” was sufficient for the jury to find that he “knowingly agreed to accept remuneration for referring patients who could be federally insured.”¹⁴ Notably, the court held that the government was not required to prove that Chun knew any particular patient who received Subsys was a Medicare beneficiary, only that his patient population plausibly included federally insured individuals.

Key Takeaway

The Eleventh Circuit has now joined the Fifth Circuit in holding that the AKS’s “knowingly” element applies to the federal healthcare program requirement. The evidentiary threshold, however, is low: Participation in Medicare or another federal healthcare program alone may be sufficient to establish the requisite knowledge. Providers should ensure AKS compliance across all patient populations that may plausibly include federally insured patients.

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The Goodwin Healthcare team will continue to monitor developments in AKS enforcement and the evolving standards for scienter and intent in federal healthcare fraud prosecutions. For more information on the issues discussed in this alert, please contact the authors or reach out to Goodwin’s Government Investigations, Enforcement & White Collar Defense group, the Healthcare Regulatory and Compliance group, or the Goodwin lawyer whom you typically consult.

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