On February 18, 2026, the Office of Inspector General (OIG) published Advisory Opinion No. 26-02, issuing a favorable opinion on a proposed arrangement in which a management services organization (MSO) would operate an independent clinical laboratory that would accept referrals from urgent care centers managed by the same MSO. While the opinion is fact-specific and limited in scope, it provides valuable insight into how the OIG evaluates laboratory arrangements involving common ownership structures under the federal Anti-Kickback Statute (AKS). This opinion is particularly relevant for MSOs and healthcare providers exploring affiliated laboratory models under increasing regulatory scrutiny.
The Arrangement at Issue
The requestor in Advisory Opinion 26-02 is a management entity affiliated with four urgent care centers. Due to state corporate practice of medicine (CPOM) restrictions, the MSO does not own the professional corporation that operates the urgent care center, but it provides oversight and management services to all four urgent care centers and holds ownership interests in subsidiary MSOs that operate each of the urgent care centers, respectively. Under the proposed arrangement, the requestor would own and operate a clinical laboratory through a separate subsidiary, and the laboratory would be physically separated from the urgent care centers. Additionally, the laboratory would bill payors, including federal healthcare programs, and would not bill the urgent care centers.
The OIG concluded that the proposed arrangement would not generate prohibited remuneration under the AKS and that administrative sanctions would not be imposed because neither the MSO nor the laboratory would be offering or paying any such remuneration to induce referrals.
OIG’s Analysis
The OIG’s analysis turned on a series of structural safeguards that, taken together, eliminated the flow of remuneration that the AKS is designed to prevent. Specifically, the requestor certified to the following key conditions:
- No compensation to any party involved would be tied to the volume or value of referrals.
- No remuneration, directly or indirectly, would flow from the laboratory to referral sources.
- Patient choice would be preserved by requiring all urgent care patients to receive written notice of the relationship between the laboratory and the urgent care centers, and the notice would include the names of other non-affiliated laboratories from which the patients can obtain services.
- The electronic health record system at the urgent care centers would allow providers to order from several laboratories without giving preference to the affiliated laboratory.
- The laboratory would not station any phlebotomists or other personnel at the urgent care centers.
- No individuals at the urgent care centers would be required to direct testing to the affiliated laboratory, and the requestor would not track referrals to the laboratory.
The OIG’s Warning: Abusive Arrangements Remain a Target
While the opinion is favorable, the OIG cautioned that “several types of abusive arrangements in which management companies own or are affiliated with laboratories and funnel kickbacks, directly or indirectly, to providers and suppliers in exchange for referrals” remain an enforcement focus. The OIG highlighted that kickbacks in this space have historically taken the form of sham investment opportunities, sham consulting arrangements, and the provision of free personnel or equipment. Such arrangements, the OIG warned, “may result in the harms the federal Anti-Kickback Statute is intended to prevent, such as improper utilization, medically unnecessary items and services, inappropriate steering, and unfair competition.”
This language signals that the OIG continues to closely scrutinize laboratory arrangements involving affiliated management structures and will pursue enforcement where remuneration is present.
Practical Takeaways
For MSOs considering the development of affiliated laboratory services, or for healthcare providers currently participating in such arrangements, this Advisory Opinion underscores the importance of rigorous structural compliance. Organizations should evaluate whether their existing or contemplated arrangements incorporate safeguards comparable to those the OIG found persuasive here. This includes the insulation of provider compensation from laboratory referral volume, the preservation of genuine patient choice, and the elimination of any direct or indirect remuneration flowing to referral sources.
In addition, although not addressed in the Advisory Opinion, arrangements involving affiliations between medical practices and clinical laboratories need to be carefully structured to comply with the strict liability Stark Law anti-self-referral requirements and implementing regulations.
How Frier Levitt Can Help
Given the OIG’s express warning about abusive laboratory arrangements in the MSO space, healthcare providers and MSOs alike are well-served by engaging experienced healthcare counsel to assess their arrangements, identify potential vulnerabilities, and implement the compliance safeguards necessary to withstand scrutiny. Frier Levitt’s healthcare attorneys bring the knowledge and practical experience needed to navigate this highly regulated space.
