The federal government chose to ease enforcement of certain regulations during the COVID-19 pandemic, but the Eliminating Kickbacks in Recovery Act (EKRA) was not one of them. This provision within the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) allows the government to impose steep criminal penalties against labs who violate its terms.
These terms include strict regulations regarding any form of remuneration. Regulations that can often get difficult to interpret when it comes to labs and marketing.
Unfortunately, even though lawmakers passed this law in 2018, neither the Department of Justice nor the Office of Inspector General for the Department of Health and Human Services have provided additional insight into its application. A recent publication in Bloomberg Law notes that this is particularly difficult when it comes to addressing differences between safe harbors provided by EKRA and a similar law, the federal Anti-Kickback Statute (AKS). These safe harbors are likely the key to using marketing within a diagnostic lab without running afoul of EKRA. Finding the right way to avoid or defend against an allegation of a violation is important, as each violation can come with a steep monetary fine and in some cases, has the potential for imprisonment.
Due to the continued lack of transparency in this laws application and the proper use of safe harbors, it is wise for any lab that receives notification of a potential EKRA violation to take the issue seriously and seek legal counsel to help protect their interests.