Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here. EKRA prohibits, among other things, the exchange of remuneration for referrals of patients or patronage to a clinical laboratory, or an individual’s use of the services of a clinical laboratory. The law, however, leaves key terms undefined, including “referral”, “patronage”, and “use of services.” This ambiguity leaves unclear exactly which forms of conduct are prohibited by EKRA. Further, EKRA contains exceptions that overlap imperfectly with safe harbors under the Anti-Kickback Statute (AKS) and states, confusingly, that EKRA “shall not apply to conduct that is prohibited” by the AKS. The latter provision imperils the status of conduct that is within an AKS safe harbor, but which does not meet the requirements of an EKRA exception. No implementing regulations have been published to alleviate any of these ambiguities.
Like other players in the healthcare industry, physician groups are facing increased antitrust scrutiny from the Biden administration, with the Federal Trade Commission (the “FTC”) and Department of Justice, Antitrust Division (the “DOJ”) (together the “Agencies”) continuing to expand their enforcement focus to include all types of transactions involving physician groups, including both traditional combinations, as well as so-called vertical combinations with health systems, payors, and private equity investors.
Continue Reading Healthcare Antitrust Update: Key Antitrust Takeaways for Physician Groups