EKRA Compliance & Labs
Originally created to eliminate kickbacks in toxicology labs, the EKRA law is now being used by the Department of Justice to target various entities in healthcare, including all types of laboratories. Whether you are a research, diagnostic, or clinical laboratory, EKRA applies to you.
Even though the law was established in 2018, it has just recently gained attention in the healthcare industry. Make sure your lab meets all requirements for EKRA compliance by following the tips below.
What is the EKRA Law?
The Eliminating Kickbacks in Recovery Act of 2018 (EKRA) was included in the passing of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUP-PORT Act).
EKRA Legislative History
Although designed to assist in the opioid epidemic, the “EKRA lab law” is quite vague and is now being used to prosecute laboratory owners, marketers, office managers, and more for either soliciting, offering, paying, or accepting kickbacks for patient referrals. The first EKRA conviction from the Department of Justice was in early 2020. The defendant faced five months of imprisonment, five months of home detention, and was ordered to pay a $55,000 fine.
EKRA penalties can include up to 20 years of imprisonment and $200,000 in fines per violation. Other penalties include licensure revocations, sanctions, and being excluded from participation in governmental healthcare programs. Due to the number of DOJ investigations, many individuals are already pleading guilty to violations. These numbers are expected to increase while the DOJ retains its focus on the EKRA law in 2021 and beyond.
EKRA vs. AKS
Are there any EKRA exceptions? Previous laws, such as the Anti-Kickback Statute (AKS) are like EKRA but have more exceptions. EKRA unfortunately applies to more healthcare entities, in addition to labs, meaning less exceptions and harsher penalties.
Public and private healthcare programs
|Federal and state healthcare programs|
|Statutory Safe Harbors||7||11|
|Regulatory Safe Harbors||0||28|
|Violation Penalties||Up to 20 years imprisonment and $200,000 fine||Up to 10 years imprisonment and $100,000 fine|
|Payments to Employees||Payments based on the number of test performed or payments received NOT allowed||Payments allowed when employment relationship is clearly defined|
What EKRA Compliance means for Laboratories
Because this law is new, and vague, there are critical steps labs need to take to meet EKRA regulations. Following these steps should point you in the right direction, but you may want to hire an EKRA attorney or a laboratory consulting service to further assist in your efforts to avoid an EKRA citation.What EKRA Compliance means for Laboratories
Review Your Vendor and Partner Relationships
According to EKRA, lab sales (patient referrals) should not be generated by kickbacks of any kind. The law is so general many believe that with the “EKRA update of 2021,” the DOJ can use it to apply to not only all laboratories, but any healthcare entity that uses a lab. Now is a great time to review your business relationships with physician offices, recovery centers, clinics, and other clinical treatment facilities to make sure there are no compensation arrangements either for their organization or yours.
Rethink Your Marketing & Sales Tactics
Many traditional marketing tactics for healthcare and laboratory industries are no longer allowed. For example, paying marketing personnel commissions based on sales is now an EKRA violation. Individuals hired to manage the sales and marketing services for a laboratory are also at risk of violations. It is advisable to rethink, revise, and frequently monitor your sales, marketing, and patient broker strategies to follow EKRA enforcements.
Consider Laboratory Consulting
If you are interested in becoming EKRA compliant with the help of a laboratory consulting company, we encourage you to start a conversation. With an expert team of business, technical and advisory lab experts all in-house, we are committed to the success of your lab.