The Eliminating Kickbacks in Recovery Act: A Critical Analysis of an Altered Landscape for Financial Relationships with Clinical Laboratories

I. Introduction -

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, seeks to prohibit “patient brokering” practices by some recovery homes and treatment facilities. However, in so doing, the SUPPORT Act raises significant challenges and questions for all clinical laboratories, even those not involved in addiction recovery programs. Until Congress amends the law or the Department of Justice issues guidance, clinical laboratories must proceed into 2019 with caution, acknowledging that many if not most of their common arrangements – including ownership, employment, lease, purchasing, independent contracting – likely need to be revisited and may need to be restructured.

II. The SUPPORT ACT and the Eliminating Kickback in Recovery Act of 2018 (“EKRA”) -

A. EKRA’s Prohibition -

Section 1822 of the SUPPORT Act, signed into law and effective as of October 24, 2018, contains the “Eliminating Kickbacks in Recovery Act of 2018” (“EKRA”), now codified at 18 U.S.C. § 220. 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 see, e.g. Energy and Commerce Committee, “How the opioids bill could halt exploitation of addicted Americans” (Oct. 9, 2018), EKRA prohibits a much broader scope of conduct, stating that...

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