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 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
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
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
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
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
As in recent years, the False Claims Act (FCA) continued to serve as a tool utilized by the federal government against government contractors in 2024. The government collected more than $2.9 billion as a result of 558 FCA...more
As we do every year, this issue revisits the key cases and other developments from the year gone by. And by most metrics, 2023 was a notable year for the False Claims Act (FCA). We start with the numbers: The Department...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 government continues to prioritize fraud involving government contractors, as the Department of Justice’s (DOJ) most recent annual report on civil fraud recovery shows. Although the majority of government recoveries are...more
On February 27, a Minnesota federal court jury ruled in the favor of the U.S. Department of Justice (DOJ) in a False Claims Act (FCA) case based on allegations of Anti-kickback Statute (AKS) violations. The focus of the case...more
The Commodity Futures Trading Commission, under a reconstituted Commission, is signaling a new era of aggressive enforcement of the Commodity Exchange Act. Significant Violations and Penalties - United States- On...more
As part of its ongoing effort to crack down on health care-related COVID-19 fraud, the U.S. Justice Department has launched a nationwide coordinated law enforcement action that recently led to criminal charges against 21...more
On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more
This is the seventh post in this year’s series examining important trends in white collar law and investigations. Our previous post discussed SEC Enforcement in 2022: A Look Ahead. Up next: ESG and the SEC: What’s Next on the...more
On Tuesday, DOJ released its eagerly awaited False Claims Act (FCA) recoveries for the fiscal year ending September 30, 2021, announcing that DOJ had obtained $5.6 billion in settlements and judgments from civil cases...more
On February 1, the U.S. Department of Justice (DOJ) announced the second-largest annual total recoveries in the history of the False Claims Act (FCA)—$5.6 billion—for FY 2021 (October 2020 – September 2021)...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
To our bad guys, 2019 was a year flush with hope and opportunity; it ended with recidivism, more misery from Venezuela, a charlatan, an Okie who pulled a multi-million dollar fast-one on Chesapeake and, as in years past, a...more
Genetic Testing Company and Three Principals Settle FCA Allegations for $42.6 Million - On October 9, 2019, New Orleans-based laboratory company UTC Laboratories Inc. (RenRX) agreed to pay $41.6 million, and its three...more
In a move demonstrating the government’s continued aim to combat health care fraud through its Health Care Fraud Prevention and Enforcement Action Team (HEAT), the Department of Justice announced today that the government has...more
There has been significantly enhanced scrutiny of financial relationships between referring physicians by both the Office of Inspector General (OIG) and Pennsylvania authorities....more
The U.S. Department of Health and Human Services Office of Inspector General's (OIG) chief counsel indicated in 2007 that the government's fraud enforcement focus on large organizations was an "ineffective strategy" and that...more