Health Law Advisor

The U.S. Court of Appeals for the Ninth Circuit has held that a laboratory owner’s payments to marketing intermediaries violated the Eliminating Kickbacks in Recovery Act (EKRA)—in its first interpretation of the statute since it was enacted in 2018.

In United States v. Schena, No. 23-2989, F.4th (9th Cir. July 11, 2025), the Ninth Circuit affirmed the convictions of Mark Schena—who in 2022 was found guilty by a federal district court jury of nine counts of health care and securities fraud. These included two counts of EKRA violations, based on illegal kickbacks to an intermediary who misrepresented the lab’s services. Schena was sentenced to 96 months in prison and ordered to pay more than $24 million in restitution. (The intermediary plead guilty to conspiracy to commit health care fraud and was sentenced to a shorter term, as was another co-defendant represented by Epstein Becker & Green attorneys.)

The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued their long-awaited proposed rules in connection with the Regulatory Sprint to Coordinated Care today.  Transforming our healthcare system to one that pays for value is one of the Department’s top four priorities, and the Deputy Secretary launched the Regulatory Sprint to remove potential regulatory barriers to care coordination and value-based care.

OIG’s proposed rule revising the safe harbors under the anti-kickback statute ...

Clinical laboratories need to review how they compensate sales personnel following the passage of the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) (Section 8122 of the SUPPORT Act) which is effective as of October 24, 2018.  The SUPPORT Act is a combination of more than 70 bills aimed at fighting the opioid epidemic, with EKRA intended to address patient brokering in exchange for kickbacks of individuals with substance abuse disorders.  However, as written, EKRA is far more expansive.

EKRA adds an all payor (public and private) anti-kickback rule to the health care fraud ...