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What happens if the feds accuse my lab of an EKRA violation?

The law is constantly evolving. One of the most recent examples is lawmakers’ attempts to address the opioid crisis. In an effort to curtail the abuse of this highly addictive medication, Congress passed the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), included within the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) in 2018. Lawmakers wrote the law to reduce the risk of referral of substance abuse patients in exchange for kickbacks to laboratories, recovery homes and clinical treatment facilities.

We are still trying to understand the full implications of this relatively new law — of particular concern because the anti-kickback prohibition was written in very broad terms and can pose a problem for labs and their marketing strategies.

How have the feds used EKRA so far?

In a recent example, the Department of Justice (DOJ) announced the conviction of the owners of an addiction treatment facility that operated out of Florida who were originally charged for various healthcare fraud crimes include EKRA violations. The feds provided evidence the group used patient brokers to pay patients to enter the facilities and then ordered medically unnecessary testing. They also accused the group of changing labs if the lab failed to refer patients to their facilities.

Ultimately, the feds convicted the healthcare business owners of healthcare fraud, wire fraud, paying and receiving kickbacks, money laundering and bank fraud. Notably absent from this list: EKRA violations. It appears that even if the feds do not pursue a conviction for EKRA violations an investigation into a potential violation means the feds may pursue other charges.

This highlights the need to review relationships with other providers to better ensure it is in line with applicable regulations, like EKRA. As the case above shows even if the feds do not choose to push for an EKRA conviction any mistakes that trigger an investigation could signal the presence of other potential issues. A failure to follow these regulations can lead to more than just a fine. If successful, the government can build a case that leads to decades in prison.

Attorney John Rivas is responsible for this communication