United States v. Hall
Facts
Hall and his partners operated compounding pharmacies that billed private and federal insurers for high-reimbursement compounded drugs. When they created Xpress Compounding to process federally reimbursed prescriptions, they claimed marketers were converted to W-2 employees, but the marketers continued to receive commission-based payments tied to prescription value and offered physicians various incentives to secure prescriptions. Between 2014 and 2016, Xpress received over $59 million in federal healthcare reimbursements. Hall was convicted on AKS counts and conspiracy to commit money laundering, and the district court ordered restitution of $59,879,871.
Issue
Whether the district court erred by instructing the jury that Hall bore the burden of persuasion on the AKS bona fide employee safe-harbor defense, by defining employee under a multi-factor common-law test rather than Hall's proposed control-focused instruction, by refusing Hall's proposed instruction about the recipients of the payments, and by ordering restitution based on the government's total loss.
Rule
Under the Anti-Kickback Statute, the bona fide employee safe harbor in 42 U.S.C. § 1320a-7b(b)(3)(B) is an affirmative defense that the defendant must establish by a preponderance of the evidence because it is a separate statutory exception that does not negate any element of the offense. For determining whether a worker is an employee for that safe harbor, courts apply the common-law multi-factor test described in Darden, under which no single factor, including the right to control, is dispositive. Under the MVRA, when the conviction involves a conspiracy or scheme, restitution may include all direct and proximate losses within the scope of the conspiracy, and conspirators may be held jointly and severally liable for foreseeable losses.
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If the trial judge properly follows the governing rule, which party bears the burden of persuasion on the bona fide employee exception, and by what standard?