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
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 Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) in the form of the DOJ-HHS False Claims...more
The Eliminating Kickbacks in Recovery Act, enacted in 2018, was a bombshell for the addiction treatment and diagnostic laboratory industries. For the first time, paying commissions for sales and marketing services was...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
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Democratic AGs Oppose Washing Away Appliance Efficiency...more
Several States' Attorneys General reported resolving a case alleging that Gilead Sciences ran an illegal kickback scheme to promote the use of its HIV medications. The government alleged that Gilead utilized various methods,...more
Emphasizing its commitment to enforcing the False Claims Act (FCA) and combating health care fraud, the Trump Administration recently instituted a DOJ-HHS False Claims Act Working Group dedicated to “combating health care...more
New York AG Letitia James, along with a bipartisan coalition of 48 other AGs and in coordination with the U.S. DOJ, announced a $202 million settlement in principle with Gilead Sciences, Inc. (“Gilead”), to resolve...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 Department of Health and Human Services and the Department of Justice have formed a False Claims Act (FCA) enforcement working group to target health care fraud. Our Health Care Litigation Group highlights what industry...more
On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act...more
On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the next phase of the Administration’s “Whole-of-Government” approach to fighting health care...more
On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...more
Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the most notable...more
On May 1, a whistleblower filed a complaint under the federal False Claims Act (FCA) against Aetna, Elevance Health (formerly Anthem) and Humana alleging that the insurers paid hundreds of millions of dollars in illegal...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
Gilead to Pay $202 Million to Settle DOJ Claims Over Speaker Program Kickbacks - Gilead Sciences, Inc. has agreed to pay $202 million to resolve allegations brought by the US Department of Justice (DOJ) that it violated...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 January 17, the Pennsylvania Attorney General filed a civil enforcement action in the U.S. District Court for the Eastern District of Pennsylvania against a group of mortgage brokers and their manager, alleging that they...more
As of February 18, 2025, the First Circuit Court of Appeals requires the government to prove “but-for” causation in Anti-Kickback Statute (AKS)-based False Claims Act (FCA) cases. The court reasoned in United States v....more
On February 18, 2025, the U.S. Court of Appeals for the 1st Circuit issued a highly anticipated ruling interpreting the relationship between the False Claims Act ("FCA") and the federal Anti-Kickback Statute ("AKS"), holding...more
President Trump Puts a “Pause” on FCPA Enforcement - On Monday, President Donald Trump signed an executive order (EO) pausing the enforcement of the Foreign Corrupt Practices Act (FCPA). According to the EO, the pause will...more