OIG Issues Favorable Advisory Opinion on Laboratory Arrangement with Urgent Care Centers

Under the proposed arrangement, the laboratory would not be owned or operated by any individuals or entities in a position to refer laboratory testing to it. The laboratory would bill payors, including Federal health care programs, directly for its services and would not bill the urgent care centers or other providers. Providers at the urgent care centers would not receive compensation tied to the volume or value of tests ordered. Patients would receive written notice of the relationship and could choose an unaffiliated laboratory, and the urgent care centers’ electronic health record system would allow providers to order tests from multiple laboratories.

The OIG determined that the Federal Anti-Kickback Statute (AKS) would not be implicated because neither the MSO nor the laboratory would pay any remuneration to any individual or entity to induce the referral of specimens to the laboratory for testing. The OIG noted that it is aware of several types of abusive arrangements in which management services organizations own or are affiliated with laboratories and funnel kickbacks, directly or indirectly, to providers and suppliers in exchange for referrals. Such arrangements violate the AKS if the requisite intent to induce referrals is present.