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 July 11, 2025, the Ninth Circuit Court of Appeals affirmed the criminal conviction of laboratory operator Mark Schena for violations of the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220 (EKRA) based on...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
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
A Florida jury recently found two laboratory co-owners of Innovative Genomics LLC (“IGX”) not guilty in connection with an allegedly fraudulent COVID-19 testing scheme. The Government alleged that from November 2019 through...more
Jury Acquitted Lab Owners in Nearly $40 Million COVID-19 Fraud Case - On March 27, a Florida jury acquitted two testing lab co-owners of conspiracy, health care fraud, and wire fraud charges. Innovative Genomics, LLC...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
Judge Orders Government to Pay Relators a Cut of FCA Settlement - On November 4, a federal judge from the US District Court for the District of Massachusetts ordered the government to pay the relators’ share of a...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
DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence - Mark Schena, the former president of Arrayit Corporation, a Silicon Valley-based medical technology company, was...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
Recently, Womble Bond Dickinson held its First Annual Health Care Fraud Symposium, a webinar designed to discuss critical healthcare fraud topics. WBD Partner Joe Whitley moderated a discussion with WBD attorneys Luke Cass,...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
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
Last Monday, the Eleventh Circuit ruled that the Middle District of Florida’s sentence of probation for former physician Nicole Bramwell in a $4.4 million Tricare fraud case was substantively unreasonable. The district...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
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
In a recent opinion from the United States Court of Appeals for the Sixth Circuit, the court analyzed several alleged points of error from a criminal jury trial about a healthcare kickback scheme. See United States v....more