On October 24, 2018, President Trump signed the Substance Use-Disorder Prevention that Promotes Recovery and Treatment for Patients and Communities (SUPPORT) Act, a combination of approximately seventy unique bills seeking to address the opioid crisis, including the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), found at Section 8121 of the SUPPORT Act. EKRA establishes an all-payor anti-kickback prohibition that extends to arrangements with recovery homes, clinical laboratories and clinical treatment facilities.
In many ways, EKRA is intended to prohibit conduct that, had a government payor been involved, would implicate the Anti-Kickback Statute (AKS). Drawing heavily from the AKS, EKRA prohibits any person, with respect to services covered by a health care benefit program, from “knowingly and willfully” paying, offering to pay, soliciting or receiving any remuneration (1) to induce a referral of an individual to a recovery home, clinical treatment facility or a laboratory; or, (2) in exchange for an individual using the services of a recovery home, clinical treatment facility or laboratory.
Like the AKS’s safe harbors, EKRA incorporates eight exceptions to its prohibitions. Some of the exceptions closely resemble or simply cross-reference the AKS safe harbors, while others contain important distinctions from their AKS counterpart. Other exceptions are simply EKRA- specific, with no federal AKS statutory or regulatory counterpart.
EKRA, like the AKS, delegates authority to create new exceptions and/or to clarify the statutory exceptions through regulations. However, unlike AKS, EKRA delegates rulemaking authority to the U.S. Attorney General, not the Department of Health and Human Services Secretary. Different agency prerogatives may lead to differences between AKS safe harbors and EKRA exceptions, bringing unique compliance challenges for affected providers.
Tackling the opioid crisis is at the top of the agenda for regulators and enforcement officials, so non-hospital medical providers who provide services relating to addiction treatment or recovery, all clinical laboratories and all recovery homes, should examine their arrangements with potential referral sources for private-pay patients. Since EKRA does not preempt state laws prohibiting the exchange of remuneration for referrals, affected providers must also ensure compliance with any overlapping state law. Because of EKRA’s ambiguities and overbreadth, and because of EKRA’s potential overlap with existing anti-referral legal frameworks, potentially affected providers are advised to seek local counsel for assistance to evaluate compliance and restructure arrangements where needed.
For a copy of EKRA, please click here.