From Bass, Berry & Sims, by Jennifer E. Michael & Danielle M. Sloane:
- The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, wherein the OIG reiterated its longstanding position that carving out federal health care program (FHCP) business from an arrangement does not insulate the arrangement from Anti-Kickback Statute liability.
- The arrangement would involve laboratories that conduct both the Technical Component (TC), preparing the slides, and the Professional Component (PC), interpreting the slides.
- The Requestor would pay fair market value (FMV) for the TC services from other labs, provide the PC, and then bill commercial insurance for both the TC and PC services. The commercial insurance policies allowed this practice.
- The arrangement would not involve any service reimbursable by FHCP, but the Requestor did expect the labs to refer FHCP services outside of this arrangement.
- The Requestor admitted the arrangement was not commercially reasonable because it could provide TC services itself for less than FMV.
- Despite the FMV payment and FHCP business carve-out, OIG determined that the arrangement could increase the likelihood that the labs or their referring physicians would order federally reimbursable services from Requestor.
- Citing its Special Fraud Alert on Laboratory Payments to Referring Physicians, OIG reiterated that the Anti-Kickback Statute is violated if even one purpose of the payment is to induce referrals of FHCP business, regardless of whether that payment is FMV.
- Finally, the proposed arrangement in Advisory Opinion 23-06 failed to meet a safe harbor only because Requestor effectively certified that the arrangement was not commercially reasonable.