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On February 12, 2026, the Department of Health and Human Services Office of Inspector General (HHS-OIG) issued Advisory Opinion No. 26-02—a favorable opinion permitting a management entity affiliated with four urgent care centers operated through various management companies and one affiliated professional corporation to operate an independent clinical laboratory and that such an arrangement would not implicate the Anti-Kickback Statute (AKS).
Although the management entity does not own the professional corporation that holds the urgent care center licenses, it does provide oversight and management services to all four of the urgent care centers. It also holds ownership interests in the management companies associated with each center. In light of these relationships, the management entity sought an advisory opinion regarding whether its operation of an independent clinical laboratory through a separate legal entity that would serve clinical testing needs of the affiliated urgent care centers would constitute grounds for exclusion from Federal health programs or the imposition of civil monetary penalties.
Arrangement does not implicate the AKS
The management entity certified that the urgent care center patients would be notified in writing of the relationship between the laboratory and the urgent care centers and offered a choice whether their test would be sent to that laboratory or an unaffiliated one. The urgent care centers would not be required to direct laboratory testing to any particular laboratory and could order from several laboratories, including through the urgent care center’s EHR system.
HHS-OIG found that—based on the facts the entity provided—the arrangement would not implicate the AKS, because:
(1) no part of any compensation received by providers or suppliers at the urgent care centers would be tied to the volume or value of services ordered from the laboratory;
(2) no remuneration would flow from the laboratory, directly or indirectly, to the urgent care centers (or any providers or suppliers that provide care at the urgent care centers); and
(3) it would not, directly or indirectly, pay remuneration to the urgent care centers (or any providers or suppliers that provide care at the urgent care centers) from any revenue derived from Laboratory services.
However, the OIG cautioned that if a similar arrangement included a situation where any remuneration—including such things as sham investment opportunities or consulting arrangements and the provision of free personnel or equipment—were to be paid to referral sources to induce or reward referrals to a particular laboratory, the AKS would be implicated, and “such conduct would not be low risk.”
What does this mean?
As is typical in an HHS-OIG Advisory Opinion, it applies only to the entity requesting the opinion and only to the extent the facts the entity provided are true; it cannot be relied upon by other persons or used as evidence to prove that that person did not violate the AKS. HHS-OIG further limited the opinion to note that it applies only to the exclusion and civil monetary penalty provisions of the AKS and does not opine on whether the arrangement implicates any other law, including the Stark Law, the False Claims Act, or any Medicaid laws.
That said, this advisory opinion can be instructive on how to structure an arrangement where an entity has an ownership interest in multiple entities where one of the owned entities could potentially refer services that are paid for by Federal health care programs to another owned entity.
Reed Smith will continue to track developments with regard to fraud and abuse regulation. If you have questions about your existing arrangement or how to structure a contemplated arrangement to comply with AKS requirements, or would like assistance in requesting an advisory opinion from OIG, please do not hesitate to reach out to a Reed Smith attorney today.