Five years ago Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). Aimed at combating kickbacks in the addiction treatment industry, EKRA prohibits remunerations in return for patient referrals to recovery homes, clinical treatment facilities, and laboratories. Unique among federal healthcare fraud and abuse laws, EKRA applies to private payors in addition to governmental payors. The law establishes severe criminal penalties for companies who violate its provisions, including a fine of up to $200,000, ten years in prison, or both, per violation.
While the intent behind EKRA was to counter perceived fraud and abuse in the addiction treatment industry, the inclusion of laboratories as a type of entity covered by the law’s prohibitions dramatically increased its scope. EKRA covers all laboratory services, whether such services are part of an addiction treatment program or not. Initially, the industry questioned whether the DOJ would pursue enforcement outside the addiction space, but with the advent of the COVID-19 pandemic, the DOJ used EKRA as a tool to combat fraud related to COVID-19 testing. For example, in United States v. Lepetich, the DOJ charged the owner of a clinical laboratory after allegedly offering kickbacks for referrals of specimens used in COVID 19 and respiratory pathogen testing.[1]
We anticipate that the DOJ will continue to use EKRA as a tool in its kit to combat fraud and abuse in the laboratory testing space. As such,...
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