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 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
Jury Clears SuperValu of Liability in Whistleblower FCA Prescription Pricing Case - A federal jury in Illinois recently found SuperValu not liable in a whistleblower lawsuit that accused the company of overcharging the...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
Massachusetts District Court Judge Applies Heightened Causation Standard in FCA Case - On January 6, a District Court of Massachusetts judge granted summary judgment for defendants on allegations of violating the...more
Following our annual tradition — which started over a decade ago — we are analyzing the year's 10 most significant whistleblower and retaliation events. As you'll see, in 2024, actions taken by a range of courts and...more
The U.S. Department of Justice (DOJ) announced in a Nov. 12, 2024, press release that an ophthalmology practice with offices located in West Central Florida (the Provider) entered into an approximately $1.3 million settlement...more
Intensifying international crises, increasing regulatory burdens, and uncertain macroeconomic conditions have led to an era of caution for manufacturers, but hidden among those challenges are exciting opportunities for...more
US Supreme Court Declines to Consider AKS ‘Willfulness’ Question - On October 7, the US Supreme Court denied a petition in which a whistleblower asked the Court to decide whether a “willful” act under the federal...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
Corporate Whistleblower Awards Pilot Program (“Pilot Program”), aimed at incentivizing whistleblowers to report potential criminal conduct. The announcement was anticipated, having been previewed in March 2024 by Deputy...more
Former Congressman George Santos Pleads Guilty to Wire Fraud and Aggravated Identity Theft - On August 19, former US Representative George Santos pleaded guilty to wire fraud and aggravated identity theft. As part of the...more
As value-based care (VBC) models continue to grow across our nation’s health system and specifically within different specialties like nephrology, the costs and challenges of maintaining these models continue to rise. In...more
DOJ Launches Corporate Whistleblower Awards Pilot Program - On August 1, the US Department of Justice (DOJ) announced the details of its new Corporate Whistleblower Awards Pilot Program. According to the DOJ, the...more
On August 1, 2024, the Department of Justice (DOJ) released a 14-page memorandum outlining the Corporate Whistleblower Awards Pilot Program announced earlier this year. Deputy Attorney General Lisa Monaco explained in her...more
Precision Lens Pays $12 Million to Resolve FCA and AKS Violations - Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more
Federal Court Dismisses $680 Million FCA Suit - On July 23, a Maryland federal judge, Ellen L. Hollander, dismissed a $680 million False Claims Act (FCA) suit that was previously revived by the US Supreme Court. The suit...more
For years, Department of Justice officials have stressed how important chief compliance officers are as the first line of defense in fighting corporate crimes. While that’s true, compliance programs now have a competitor in...more
Florida Lab Owner Agrees to Pay Over $27 Million to Resolve Three Whistleblower Lawsuits - Daniel Hurt, the prior owner and operator of Fountain Health Services LLC, Verify Health, Landmark Diagnostics LLC, First Choice...more
DOJ Secures Plea in $50 Million Medicare Fraud and Kickback Scheme - On April 26, the US Department of Justice (DOJ) announced that Manishkumar Patel pleaded guilty to charges related to a $50 million health care fraud and...more
On April 15, 2024, the Criminal Division of the Department of Justice (DOJ) announced a new pilot program setting forth the circumstances in which it will offer non-prosecution agreements (NPAs) to individuals who voluntarily...more
Senate testimony focusing on the impact of the rising presence of private equity (PE) firms’ control of major healthcare providers touched on the “substantial overlap between the risks associated with private equity ownership...more
The U.S. Department of Justice (DOJ) announced recently that settlements and judgments under the False Claims Act, 31 U.S.C. § 3729, et seq. (FCA) totaled approximately $2.7 billion in FY 2023 (October 1, 2022 – September 30,...more
The U.S. Department of Justice (“DOJ”) announced its False Claims Act (“FCA”) enforcement statistics for FY 2023 and identified key priorities for FCA enforcement in 2024 and beyond. The DOJ continues to pursue 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