Recently the Office of Inspector General (OIG) for the Department of Health and Human Services issued Advisory Opinion 15-04 which concluded that an exclusive arrangement between a laboratory and a physician practice may violate the federal anti-kickback statute (AKS). Notably, the OIG warned that the practice of writing off charges for patients of exclusive insurance contracts by laboratories that are not contracted with that insurance company may constitute prohibited remuneration under the AKS.


A large laboratory requested clarification from the OIG on engaging in agreements with their physician client practices where they would provide services to all patients, but not submit claims for those patients whose insurance was out of network or required the patient to use another exclusive laboratory. The lab would also not collect payment from the referring physician, any secondary payer or the patient. However, all other insurances, including federal healthcare programs, would be billed standard fees. This type of arrangement would allow the laboratory to offer their client the convenience of utilizing a single lab for all patients and give consistency in reporting and would aid the practice by providing an interface to the client’s EMR system but not provide any additional benefits, financial or otherwise.

OIG’s Conclusion:

According to the OIG the “proposed Arrangement could potentially generate prohibited remuneration under the anti-kickback statute and that the OIG could potentially impose administrative sanctions on [name redacted] under sections 1128(b)(7) or 1128A(a)(7) of the Act (as those sections relate to the commission of acts described in section 1128B(b) of the Act) in connection with the Proposed Arrangement. Any definitive conclusion regarding the existence of an anti-kickback violation requires a determination of the parties’ intent, which determination is beyond the scope of the advisory opinion process. In addition, we conclude that the Proposed Arrangement could constitute grounds for permissive exclusion under the exclusion authority at section 1128(b)(6)(A) of the Act.”¹ 

¹Advisory Opinion No. 15-04, II. Legal Analysis, B. Analysis, 1. Anti-kickback Statute, Page 8.

Author - Female

About the author

Leigh Polk is Pathology Marketing Specialist of McKesson Business Performance Service.