First Enforcement Related To The Eliminating Kickbacks In Recovery Act
In October of 2018, President Trump signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”), which included a controversial section entitled the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”).
EKRA is targeted at making illegal the prevalent practice of “patient brokering” in the substance use treatment industry and essentially established a prohibition on payment for referrals that is similar to, but distinct from, the federal anti-kickback statute (“AKS”). Two of the most significant differences between the AKS and EKRA are the latter’s application to all payors, not just federally-funded health care programs, and the different safe harbors that the statute outlined. The result is that one could avoid AKS liability altogether or fit an AKS safe harbor, yet still be in violation of EKRA.
If this confusing overlap with an existing regulatory prohibition on referrals is not enough, EKRA also extended to all laboratories, regardless of whether the laboratory is involved in substance abuse treatment. To add to the uncertainty, there had been no insight into how the federal government would enforce EKRA, either through regulations or through enforcement activity since the law was passed. This is why the wider health care industry is carefully monitoring EKRA.
On January 10, 2020, however, the Department of Justice (“DOJ”) announced that an 80 year old Kentucky woman pleaded guilty to violating EKRA. The case involved an office manager of a substance use treatment clinic who solicited payments from a toxicology lab CEO for referrals of patient urine drug tests. The defendant eventually admitted to such allegations and will be sentenced later this spring. She faces up to 20 years in prison and a fine of up to $250,000.
With this first guilty plea, it is clear that the lack of clarifying regulatory guidance will not stop the DOJ from enforcing EKRA under the current statutory language. For this reason, all laboratories should ensure their payment arrangements with referral sources consider EKRA compliance in addition to other fraud and abuse regulatory schemes.