Section 1822 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the “SUPPORT Act”), passed at the end of October 2018, includes the “Eliminating Kickbacks in Recovery Act of 2018” (“EKRA”). Although EKRA was created to address “patient brokering,” the practice by recovery homes and treatment facilities of engaging third parties, or “body brokers,” to recruit patients in exchange for kickbacks, EKRA’s language prohibits a much broader scope of conduct. Specifically, EKRA has significant implications for any financial relationship that any clinical laboratory has with any individual or legal entity that generates business for it, even for clinical laboratories not involved in addiction recovery programs – including ownership, investment, employment, lease, purchasing, and independent contractor arrangements.
While EKRA is in many ways similar to the Federal health care program anti-kickback statute, 42 U.S.C. 1320-7b(b) (the “AKS”), it is much broader in scope for a number of reasons, including its application to clinical laboratory services paid for by any payor (including commercial insurance and self-pay patients), its limited number of safe harbors, its disregard for the AKS’ safe harbors, and its seeming accommodation of more stringent state kickback laws. Thus, for many clinical laboratories and their owners, investors, and contractors, EKRA may require a careful reevaluation and reassessment of the risk of many previously unimpeachable financial arrangements. In fact, many common arrangements likely need to be revisited and may need to be restructured. For a more in-depth examination of EKRA and the issues it poses for clinical laboratories, Sheppard Mullin’s critical analysis is available here: The Eliminating Kickbacks in Recovery Act: A Critical Analysis of an Altered Landscape for Financial Relationships with Clinical Laboratories.