On February 23, 2022, a district court in the Central District of California denied a defendant’s motion to dismiss a qui tam suit premised on alleged Anti-Kickback Statute (“AKS”) violations, holding that “even some fair-market-value payments will qualify as illegal kickbacks.” See United States ex rel. Chao v. Medtronic PLC, No. 17-cv-1903 (C.D. Cal.).
The relator’s operative complaint argued that the defendant, a manufacturer of medical devices, violated the FCA by offering kickbacks in various forms to reward physicians for using the defendant’s devices. Among other arguments, the defendant urged the court to dismiss the complaint because the relator failed to allege that certain payments to physicians for proctoring other physicians on how to use the medical devices exceeded fair market value (“FMV”). As such, the defendant contended, the relator failed to address the potential applicability of the AKS’s personal services safe harbor.
The court concluded, however, that the relator need only “allege facts that make it plausible that the safe harbor will not defeat his claim,” which he had done. Therefore, the personal services safe harbor could not serve as a basis for dismissal on the pleadings. Furthermore, the court explained that even if the payments were consistent with FMV, this would not immunize the defendant from FCA liability. In the court’s view, FMV payments can qualify as illegal kickbacks when “the payor has considered the volume of reimbursable business between the parties in providing compensation and otherwise intends for the compensation to function as an inducement for more business.” Such conduct removes the payments from the safe harbor, the court explained, regardless of whether they were at FMV.
In so finding, the court aligned itself with DOJ, which asserted in a Statement of Interest that if payments were also intended to compensate for referrals, then they can violate the AKS, even if the payments were at FMV. As such, reiterating a position it has taken in other cases, DOJ argued that “FMV, standing alone, is not a defense to the AKS.” Even offering someone “an opportunity to earn money may well be an inducement to that person to channel potential Medicare payments towards a particular recipient” in violation of the AKS. This opinion serves as a reminder that FMV assessments can be a necessary but not sufficient means to address compliance risk.
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