EKRA Turns Five: Enforcement Trends and Questions

• May 31, 2023

• Purvi Badiani Maniar , Norton Rose Fulbright
• Sarah Jean Kansagra , Norton Rose Fulbright
• Erin Riley , Norton Rose Fulbright

Key Insights and Takeaways

• Unlike the Anti-Kickback Statute (AKS), the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) prohibits remunerations for referrals of patients insured by any third-party payer (i.e., commercial payers) to recovery homes, clinical treatment facilities, and laboratories. Thus, EKRA is not limited to patients insured by federal health care programs.
• EKRA’s exception for employment relationships with employees and independent contractors is narrower than the AKS safe harbor for bona fide employment relationships. Accordingly, any employment or contractor relationship between a recovery home, clinical treatment facility, or laboratory and an employee or independent contractor should be reevaluated to ensure that such relationship meets the requirements of the EKRA exception.
• We are seeing active enforcement of EKRA by the U.S. Department of Justice (DOJ) and some patterns are starting to emerge. Additionally, although EKRA was originally intended to combat schemes by which patient brokers took advantage of individuals suffering from substance use disorders (SUDs), its applicability to laboratory settings is not limited to SUDs and it is being used to curb abuse in other areas such as labs engaging in COVID-19 testing, respiratory pathogen testing, and allergen testing.
• It is currently unclear how EKRA will be enforced in cases not involving direct remunerations and what kinds of arrangements the DOJ will deem sufficient to impose EKRA liability versus what kinds of arrangements the DOJ will deem too attenuated to impose EKRA liability.

ARTICLE TAGS

• Behavioral Health Practice Group
• Behavioral Health
• Fraud and Compliance