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Diagnostic Testing Labs And EKRA Compliance


With the enactment of the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), health care providers face additional regulations affecting their operations. The organizations affected include diagnostic testing labs, substance abuse clinics and recovery homes. Failure to follow the Act’s provisions can lead to fines of up to $200,000 and a prison sentence of up to 10 years for each occurrence.

EKRA In A Nutshell

EKRA is one of many governmental initiatives designed to deal with the opioid crisis. Its restrictions are more stringent than those of the Anti-Kickback Statute (AKS). EKRA contains many complex aspects, but its core provisions are:

  • EKRA prohibits the solicitation, payment or acceptance of any remuneration (such as a kickback, bribe or rebate) for referring a patient to a laboratory, treatment facility or recovery home.
  • It applies to both employees and contractors.
  • There are exceptions when the amount of compensation or payment does not vary based on the:
    • Number of individuals referred to a lab or facility
    • Number of tests or procedures performed
    • Amount billed to a healthcare benefit program

It appears that EKRA prohibits many types of commission-based compensation programs used by diagnostic testing labs. In some respects, the exceptions allowed by EKRA are like those of the safe harbor provisions of the AKS. Still, there are significant differences that diagnostic testing laboratories need to know.

How We Can Help

Rivas Goldstein, LLP, has a team of highly knowledgeable health care law attorneys. We have many years of experience assisting diagnostic testing labs in complying with the complex web of laws and regulations affecting their businesses to help them succeed.

Our firm can:

  • Educate executives and managers regarding EKRA and how it affects your business
  • Conduct an audit of your compensation policies and billing practices to assess compliance with EKRA
  • Recommend changes to compensation policies and billing practices ensuring compliance

If a problem does arise, our lawyers will vigorously defend you and your business to avoid prosecution and minimize potential penalties.

Call Us For More Information

Our lawyers are ready to help you. For help with an EKRA compliance issue, contact our Austin office by calling 800-761-5190 or via email.