Alerts2.25.26
HHS-OIG Issues Favorable Advisory Opinion on Laboratory Arrangement Between Management Entity and Affiliated Urgent Care Centers
Highlights
- The U.S. Department of Health and Human Services-Office of Inspector General (HHS-OIG) released Advisory Opinion No. 26-02, a favorable opinion concluding that a proposed arrangement in which a management entity would operate an independent clinical laboratory providing services to patients of the manager’s affiliated urgent care centers would not generate prohibited remuneration under the Federal Anti-Kickback Statute (AKS) and would not warrant administrative sanctions.
- HHS-OIG found that the arrangement did not implicate the AKS because the requestor certified that no remuneration would flow from the laboratory, directly or indirectly, to the urgent care centers or any providers or suppliers furnishing care at those centers, and no compensation paid to urgent care center providers would be tied to the volume or value of services ordered from the laboratory.
- Despite the favorable result, HHS-OIG cautioned that if any remuneration were paid to referral sources to induce or reward the referral of laboratory specimens to a particular laboratory for federally reimbursable testing, the AKS would be implicated, and such conduct could expose the parties to sanctions.
The management entity requesting the opinion (the requestor) is affiliated with four urgent care centers in a single state, which are operated through various management companies owned by the requestor and one affiliated professional corporation. Due to state law corporate practice of medicine restrictions, the requestor does not own the professional corporation that holds the urgent care clinic licenses; however, the requestor provides oversight and management services to all four urgent care centers and holds ownership interests in the management companies associated with each center.
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