Recently, Holland & Knight healthcare attorneys have received questions as to whether the Eliminating Kickback in Recovery Act (EKRA) is still in effect, given the recent expiration of many provisions of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. The answer to this question is "yes." EKRA is not limited by an appropriations authorization, and does not have a sunset provision.
Congress enacted EKRA in 2018 as part of the SUPPORT Act, which is comprehensive legislation designed to address the opioid crisis. Certain provisions of the SUPPORT Act had five-year funding appropriation authorizations, for the fiscal years 2019 through 2023, and without additional legislation reauthorizing appropriations for such provisions, these expired in 2023. Additionally, certain provisions of the SUPPORT Act contained specific "sunset" provisions that automatically expired on certain dates, or after certain time periods, unless renewed by legislative action. EKRA, however, contains neither an appropriations limitation nor a sunset provision, and therefore EKRA remains in full effect (and it will continue to remain in effect unless or until it is amended or repealed).
As previously reported on this blog, EKRA makes it a criminal offense to offer or receive any remuneration in an exchange in order to "induce" a referral to a recovery home, clinical treatment facility or a clinical laboratory. EKRA is an "all-payer" statute, which means it applies to services that are paid by commercial insurers in addition to services paid by Medicare and Medicaid.
The U.S. Department of Justice (DOJ) continues to use EKRA as an enforcement mechanism for eliminating fraud, waste and abuse in the clinical laboratory industry. Notably, and as we previously reported, the DOJ has broadly construed and applied EKRA not just to toxicology labs, but to all clinical laboratory activities, including COVID-19 testing.
While to date there have been limited enforcement actions under EKRA, stakeholders in the clinical laboratory industry should continue to structure their operations to remain compliant with all aspects of the law.
