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When does marketing become an EKRA violation?

| Jul 1, 2021 | Diagnostic Lab |

The Eliminating Kickbacks in Recovery Act (EKRA) is part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act singed into law in 2018. This law impacts clinical treatment facilities and recovery homes as well as labs. Lawmakers wrote the law broadly. As a result, it applies even when the referral has nothing to do with treatment for opioid addiction or recovery. This broad language is concerning, as we still do not know exactly how the feds will enforce the law.

Why the need for EKRA? Doesn’t the government already have this type of law?

Prior to EKRA, the government often used the Anti-Kickback Statute (AKS) to cover these types of cases. EKRA does not replace AKS, but instead provides an additional tool for the government to fill in an important gap in AKS. AKS only applies to federal programs, while EKRA also covers private payors.

How do the feds build an EKRA claim?

In order to build an EKRA claim, the feds must generally show either that the accused knowingly and willfully solicited or received remuneration for a referral or that the accused paid or offered remuneration for the referral.

How can businesses distinguish between an EKRA violation and marketing?

EKRA states that payment to sales personal is not a violation if the payment does not vary by the number of individuals referred, tests or procedures performed, or the amount billed or received. This seems to directly target the use of commission-based payments to sales personnel.  However, the AKS also prohibits improper remuneration in a similar manner and provides safe harbors have allowed healthcare businesses the ability to use commission-based payments to sales personnel. There is the possibility that a poorly worded exemption within EKRA may serve this same purpose.

Ultimately, we still waiting on the feds need to provide more clarity on their expectations. Once provided, laboratory executives will need to stay abreast of these expectations and make changes as needed to better ensure compliance.

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