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Key reason EKRA poses unique risk for labs

Congress enacted the Eliminating Kickbacks in Recovery Act (EKRA) in 2018 as part of an overall push to address the opioid crisis. Lawmakers intended this law to provide authorities with the ability to hold medical professionals accountable who received kickbacks in exchange for unnecessarily prescribing this dangerous, highly addictive medication.  Although noble in purpose, the reality of this law may come with more hurdles than intended.

One of the key issues that could cause problems involves some ambiguity. Although the law is clear in its definition of a clinical treatment center, it is vague in what it defines as a lab.  According to the language of the law, a lab is defined 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.”  42 U.S.C. 263a.  Legal professionals have voiced concerns that under this definition the term lab is broad enough to cover essentially any health care facility that uses any type of lab services. The law is also vague with its definition of a referral. The vagueness with these two terms provides federal agencies with increased freedom to conduct investigations.

How can labs address EKRA?

One option is to conduct an internal audit. This provides an opportunity to review marketing strategies to better ensure compliance with this law. Ideally, an audit will catch any potential issues early on, allowing the opportunity to adjust and better ensure compliance before a potential problem rises to the level of a violation.