The Office of Inspector General (OIG) recently issued Advisory Opinion No. 26‑02, offering a favorable determination on a proposed arrangement in which a management company affiliated with several urgent care centers would establish and operate an independent clinical laboratory. In its Feb. 12, 2026, opinion, OIG concluded that, based on the certified facts, the arrangement would not generate prohibited remuneration under the federal Anti‑Kickback Statute and therefore would not trigger administrative sanctions.
Although the opinion is binding only on the requesting party, it provides important guidance for health care clients considering opening, acquiring or affiliating with a clinical laboratory, especially in the context of urgent care, physician practices or management services organizations.
Why OIG Approved the Arrangement
OIG’s favorable conclusion rested on several structural features designed to eliminate referral‑based financial incentives.
First, the Laboratory and the management entity did not provide any direct or indirect payments for laboratory referrals. This included no revenue‑sharing; no payments tied to ordering volume or value; no consulting fees or investment opportunities; and no subsidized personnel, equipment or space. OIG emphasized that none of the Laboratory’s revenue would flow back to the urgent care centers or their clinicians.
Second, the urgent care providers had no ownership interest in the Laboratory and were not positioned to profit from referrals. This separation of economic interest was central to OIG’s analysis.
Third, the urgent care centers implemented safeguards to ensure transparency and preserve independent clinical judgment:
- Patients received written notice explaining the relationship between the centers and the Laboratory.
- Patients were offered a choice of labs.
- Providers were not required or encouraged to use the affiliated laboratory.
- The Electronic Health Record system permitted ordering from multiple laboratories without prioritizing the affiliated lab.
Fourth, the Laboratory billed insurers, including federal health care programs, directly, and did not bill the urgent care centers for services. The absence of financial flows between the entities reduced Anti-Kickback Statute-risk.
Fifth, the Laboratory did not supply free phlebotomists or other personnel. Specimen collection was performed solely by existing urgent care staff as part of routine care, mitigating potential remuneration concerns.
OIG’s Compliance Warning to the Industry
The advisory opinion includes a clear and direct caution: similar arrangements may violate the Anti-Kickback Statute if they involve remuneration — direct or indirect — to induce testing referrals. OIG highlighted several high‑risk structures it continues to see in enforcement matters, including sham investment or ownership interests; inflated or nonexistent consulting arrangements; or free or subsidized staff, equipment or space. These arrangements may lead to overutilization, medically unnecessary testing and inappropriate patient steering — all harms the Anti-Kickback Statute is designed to prevent.
Practical Guidance for Health Care Clients Considering Opening a Laboratory
Clients exploring similar operational structures should consider implementing the following safeguards:
- Ensure referring physicians do not hold ownership interests in the laboratory.
- Keep the laboratory operated through a separate legal entity where appropriate.
- Do not provide compensation, revenue‑sharing or indirect benefits based on volume or value of tests.
- Avoid discounted services, free staff, equipment or supplies flowing to referral sources.
- Provide clear written disclosures to patients about any affiliation.
- Allow patients to freely choose any laboratory.
- Maintain a neutral Electronic Health Record ordering system without baked‑in preferences.
- The laboratory should bill payors directly for its services.
- Providers or urgent care centers should not receive payments tied to testing.
- Document the absence of remuneration arrangements.
- Conduct periodic audits to ensure compensation is not tied to ordering patterns.
- Train providers and staff on Anti-Kickback Statute‑compliant ordering practices.
Limitations and Other Regulatory Considerations
OIG emphasized that this advisory opinion applies only to the requestor and the certified facts presented; does not address the Stark Law or state corporate practice rules; and does not address False Claims Act liability for improper billing. Clients designing similar laboratory arrangements must ensure compliance with these additional regulatory frameworks, each of which may impose separate restrictions.
Conclusion
OIG Advisory Opinion No. 26‑02 provides a useful guide for structuring a compliant laboratory arrangement that avoids Anti‑Kickback Statute pitfalls. The decision underscores that strict separation of financial interests, transparency to patients and neutral ordering systems are essential components of a low‑risk structure.
Organizations considering establishing or affiliating with a clinical laboratory can reduce regulatory risk by implementing the safeguards that formed the basis of OIG’s favorable opinion.
We would be happy to assist your organization in structuring or reviewing a proposed laboratory arrangement; evaluating AKS, Stark, and state law implications; preparing compliance policies and patient disclosures; and conducting training for providers and staff.
If you require assistance or have questions, please reach out to attorney Roy W. Breitenbach at (516) 880-8378 and rbreitenbach@harrisbeachmurtha.com; or the Harris Beach Murtha attorney with whom you most frequently work.
This alert is not a substitute for advice of counsel on specific legal issues.
Harris Beach Murtha’s lawyers and consultants practice from offices throughout Connecticut in Bantam, Hartford, New Haven and Stamford; New York State in Albany, Binghamton, Buffalo, Ithaca, New York City, Niagara Falls, Rochester, Saratoga Springs, Syracuse, Long Island and White Plains; as well as in Boston, Massachusetts, and Newark, New Jersey.