In a recent advisory opinion, the Office of Inspector General ruled a specific urgent care management service organization’s plan to run an affiliated clinical lab would not create prohibited “remuneration” under the federal Anti-Kickback Statute, according to a Feb. 26 blog post from law firm Morgan Lewis.
Here are nine more things to know
1. The judgment is a narrow green light, not a broad endorsement of affiliated lab models. The report the emphasizes it comes amid ongoing enforcement targeting lab and ancillary arrangements, especially those using MSOs or layered contracts to mask referral payments
2. The deciding factor was the requestor’s certification that no direct or indirect money would flow between the lab and the urgent care centers, and that provider compensation would not change with lab use, according to the blog post. If ancillary revenue can reach referral sources, through any route, AKS risk spikes.
3. The move signals providers can’t “contract your way” out of AKS exposure if the real-world economics effectively reward referrals. Structures that look clean on paper but function like referral incentives remain vulnerable.
4. In the ruling, the OIG leaned heavily on workflow safeguards showing referrals wouldn’t be steered. Providers could order from multiple labs in the EHR without preference for the affiliated lab. This reinforces that staffing, workflow integration and tech design can create AKS problems even without overt payments.
5. The lab would operate off-site from the urgent care locations and would not station personnel at the urgent care sites. That separation matters because on-site presence and embedded lab staff can become subtle steering mechanisms, and a fact pattern regulators scrutinize.
6. Notably, people in a position to order or refer tests would not own or operate the lab. OIG is effectively underscoring that ownership by referral sources is one of the fastest ways to turn ancillary expansion into an enforcement target.
7. The lab would bill payers directly, including federal healthcare programs, rather than routing money through the urgent care entity. Direct billing helps limit “money trails,” but the bigger issue remains whether any value still redounds to referral sources.
8. Additionally, patients would get written disclosure and preserve freedom to choose a lab, and providers would have unfettered ability to select non-affiliated labs.
9. The OIG explicitly doesn’t mention Stark law, meaning the same structure could still trigger physician self-referral issues depending on compensation terms, fair market value, commercial reasonableness and volume or value features. For MSO-supported platforms, parallel Stark law analysis will be needed.
