The Eliminating Kickbacks in Recovery Act of 2018 (EKRA) was originally created to eliminate kickbacks in toxicology labs. In recent years this “lab law” has been used to prosecute laboratory owners, office managers, and more for accepting, offering, soliciting, or paying kickbacks for patient referrals. Although the EKRA law is vague and general, it applies to all laboratories. Keep in mind that penalties include up to 20 years of imprisonment, licensure revocations, $200,000 in fines per violation, and more. So if you run a research, diagnostic, or clinical laboratory it is important to work with a laboratory consultant to make sure your lab meets all requirements for EKRA compliance. Here’s what you need to know about EKRA.
1. What to know about EKRA?
The EKRA is similar to the Anti-Kickback Statute however, the EKRA differs from these statutes in several important respects. EKRA defines “laboratory” very broadly as “a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.” This means that it includes all clinical laboratories, so your laboratory can be prosecuted by the feds for EKRA violations.
2. It prohibits all forms of remuneration with some exceptions
Section 220(a) of EKRA prohibits three specific types of knowing and willful conduct:
Offering or paying any remuneration in exchange for a patient using the services of a clinical treatment facility, laboratory, or recovery home.
Soliciting or receiving, any remuneration (including any kickback, rebate, or bribe), in exchange for referring a patient to a clinical treatment facility, laboratory, or recovery home;
Paying or offering any remuneration to induce the referral of a patient to a clinical treatment facility, laboratory, or recovery home.
However, there are some exceptions although not as extensive as those under the Anti-Kickback Statute. Section 220(b) provides the following types of offers and payments excepted from the prohibitions in Section 220(a). These include disclosed price discounts, bona fide employee compensation, Medicare Part D discounts, personal services, copay waivers, federally qualified health centers, and alternative payment models. The EKRA also allows for the adoption of additional exceptions by regulation, so it is best to talk to a laboratory consultant before assuming anything.
3. The penalties for violating EKRA
The EKRA is a criminal statute, and this means that facility owners, company managers, professionals, and other providers that violate the law can face fines and federal imprisonment. Penalties range from a $200,000 fine up to 10 years in prison or both.
EKRA is not something to take lightly, therefore it is crucial to have the guidance of a laboratory consultant that reviews your current setup to see if you might have any violations. Through our consulting services, you'll be able to ensure that your lab facility has the documentation on hand to prove compliance and the success of your lab. Contact us today!