Must the government establish subjective intent to engage in unlawful conduct in order to convict a defendant of healthcare fraud and violation of the anti-kickback statute?

QUESTION PRESENTED In Ruan v. United States, 142 S. Ct. 2370 (2022), this Court made clear that there must be subjective intent to commit an unlawful act to convict a defendant under the Controlled Substances Act. This case involves the very similar context of healthcare fraud and the anti-kickback statute, but the courts below found intent based on an objective intent standard. Petitioners were marketers who advertised compound drugs. Medical professionals would, in their discretion, write a prescription and send it to a pharmacy. The pharmacy filled it and submitted a claim for reimbursement to a pharmacy benefit manager who processed the claim for the patient’s insurance. The pharmacy then paid one Petitioner, Wilkerson, a commission and he passed a portion on to the others. Neither lower court made specific findings of intent. The district court convicted Petitioners based on the failure to disclose the cost of advertised drugs. The Sixth Circuit affirmed on different reasoning, inferring intent based on a string of incidents involving one or more Petitioner, including that: they used a pre-set order form (created by pharmacies); some mentioned a clinical trial that was ultimately not conducted; in a few instances some paid co-pays; some targeted patients with certain insurance; and some were involved with a few prescriptions the court criticized but with no finding of lack of medical necessity. The court conceded these incidents could have innocent explanations but decided that by aggregating them it could infer intent for all Petitioners. The question presented is: Must the government establish subjective intent to engage in unlawful ii conduct in order to convict a defendant of healthcare fraud and violation of the anti-kickback statute?