Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
The Administrative False Claims Act (AFCA), enacted in December 2024, expands agency authority and recovery limits, making the AFCA a more powerful tool for recouping government funds lost to alleged false claims—a...more
The US government and private plaintiffs use the False Claims Act (FCA) – a federal statute originally enacted in 1863 in response to defense contractor fraud during the American Civil War – to combat various forms of fraud...more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
On October 15, Maryland Attorney General Anthony G. Brown announced that his office reached a $27 million settlement with Precision Toxicology to resolve allegations that it submitted false claims to government health...more
The U.S. Securities and Exchange Commission (SEC) brought more actions targeting regulated entities for recordkeeping violations related to employees using noncompany communications platforms, and both the SEC and the U.S....more
The federal False Claims Act (FCA) is widely regarded as a powerful tool to punish fraud against the federal government. Since 1986, the federal government has recovered more than $75 billion from FCA settlements and...more
The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more
On May 17, 2022, the US Court of Appeals for the DC Circuit issued an opinion in a False Claims Act suit, narrowly interpreting the so-called “government-action bar.” The government-action bar, 31 USC § 3730(e)(3), forecloses...more
Cyber whistleblowing is the newest and hottest area of exposure for organizations. All government contractors and grant recipients must develop an understanding of the use of the False Claims Act (FCA) to address...more
A relator is a private person or entity who files a False Claims Act (FCA) lawsuit on behalf of the United States in exchange for receiving a portion any recovery from the defendant. The FCA was enacted in 1863 in response to...more
A defendant who violates the FCA can be liable for treble damages plus a civil penalty of $5,500 to $11,000 (adjusted for inflation) for each false claim. Meanwhile, FCA lawsuits often involve tens of thousands of alleged...more
The United States Attorney’s Office for the Northern District of West Virginia announced a renewed emphasis on health care fraud prosecutions in West Virginia as of January 19, 2022. It formed the Mountaineer Health Care...more
Last week, a bipartisan group of Senators led by Senator Chuck Grassley (R-Iowa) introduced two pieces of proposed legislation, one of which would amend the False Claims Act (FCA) and the other of which would amend the...more
On January 14, 2021, the United States Department of Justice (“DOJ”) issued its annual press release highlighting its recoveries from False Claims Act (“FCA”) enforcement over the last fiscal year. Total recoveries in FY2020...more
Russian National Sentenced to Prison for $100 Million Cyber Fraud Conspiracy - On October 30, 2020, a Russian national was sentenced to eight years in prison for his role in a scheme to illicitly obtain and use sensitive...more
Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...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
This week the Department of Justice reported it recovered $3 billion from False Claims Act cases in 2019. Of that recovery amount, $2.1 billion resulted from whistleblower, or qui tam, actions. In addition, 633 new qui tam...more
The Supreme Court held that the FCA’s extended limitations period is available to relators in qui tam cases even when the government declines to intervene. Lower courts continued to divide over the first-to-file bar,...more
Compound Ingredient Supplier to Pay Over $22 Million to Resolve Allegations Brought Under Qui Tam Provisions of FCA - On November 7, 2019, the Department of Justice (DOJ) announced that Fagron Holding USA LLC (Fagron) had...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 this episode, Mark Rush and John Lawrence discuss the federal government’s expectations related to health care organizations conducting internal investigations and demonstrating a commitment to compliance. The episode also...more
Healthcare Management Associates (HMA) settled criminal and civil charges with the Justice Department for illegal fraud and kickback schemes. HMA billed federal government healthcare programs for inpatient services that...more
A United States District Court (Eastern District-Pennsylvania) (“Court”) addressed a qui tam action filed by Gary Cressman (“Cressman”) under the federal False Claims Act (“FCA”) in connection with an alleged environmental...more
Recent congressional action will have serious ramifications on corporate and individual defendants who are or could be under investigation for violations of federal health care program fraud and abuse laws. Changes...more