Medical Device Legal News with Sam Bernstein: Episode 14
The Justice Insiders: FIFA Corruption Trial – Will the Feds Score Another Goal?
Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
On July 11, 2025, in United States v. Schena,[1] the Ninth Circuit adopted an expansive interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), applying the law to any payment that could have the effect of...more
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...more
The health care industry – already bracing for the financial impact of Medicaid cuts – faces another hard truth: This administration isn’t slowing the pace of health care fraud enforcement. Rather, it’s doubling down on...more
In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...more
On June 30, 2025, New York Attorney General (AG) Letitia James announced new lawsuits, criminal charges, and settlements with 25 New York transportation companies related to alleged schemes to defraud Medicaid of millions....more
Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more
Key Takeaways - First Appellate Interpretation of EKRA: The Ninth Circuit’s decision in United States v. Schena marks the first appellate court interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), affirming...more
The U.S. Attorney’s Office for the Eastern District of Pennsylvania announced on April 23 that Genexe, LLC (doing business as Genexe Health) and its parent company, Immerge, Inc., along with two of their executive...more
The Office of Massachusetts Attorney General (AG) Andrea Campbell announced the criminal indictment of several Massachusetts-based health care providers and their owners in connection with allegedly false claims they...more
On June 27, 2024, the Department of Justice (DOJ) announced its 2024 National Health Care Fraud Enforcement Action, which resulted in criminal charges against 193 defendants for alleged participation in various health care...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for March 2023. We discuss several criminal and civil enforcement actions that involve Anti-Kickback Statute (AKS) and...more
The Department of Justice (DOJ) released its annual summary of False Claims Act (FCA) recoveries for the prior fiscal year, and the data points to a number of notable trends. Although DOJ brought in the second-highest...more
Yesterday, the U.S. Department of Justice (DOJ) announced that it has filed charges against 36 defendants in relation to an alleged health care fraud scheme that resulted in approximately $1.2 billion in fraudulent payments....more
Prosecutions related to the submission of claims to Tricare for compounded pain creams continue. The Eleventh Circuit Court of Appeals affirmed convictions against a Florida pharmacist, physician, and Navy veteran for their...more
The Justice Department announced the arrest and indictment of Charles Hunter Hobson for violating the FCPA, money laundering and receiving kickbacks arising from a bribery scheme to pay government officials in Egypt in...more
On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for...more
Little problems can become big ones. A failure to respond to a risk – whether it is a conflict of interest violation or a weakness in internal controls – can become even more significant depending on the size and scope of...more
This month, the Department of Justice (DOJ)—as a product of the Criminal Division’s continued efforts to combat healthcare fraud—announced criminal charges against over 100 defendants, including 42 doctors, nurses, and other...more
A False Claims Act case can easily turn into a criminal prosecution. The Federal Bureau of Investigation often initiates criminal investigations as part of its commitment to reducing health care fraud....more
The False Claims Act is a powerful enforcement tool. The Justice Department with its partner agencies are ramping up enforcement efforts. The Biden DOJ is preparing to implement an aggressive FCA program across healthcare,...more
On May 26, 2021, DOJ announced a series of coordinated law enforcement actions against 14 defendants across seven federal districts for alleged participation in fraudulent health care schemes that, according to the...more
DOJ’s Antitrust Division is increasing criminal antitrust enforcement. After two relatively slow years of criminal enforcement, the Antitrust Division’s criminal enforcement program is steadily increasing....more
The Department of Justice (DOJ) has announced its first criminal securities fraud prosecution related to COVID-19, and it involves health care fraud as well. Mark Schena, president of Arrayit Corporation, a publicly traded...more
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more
The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more