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 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
Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional - On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more
Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....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
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations - A New Jersey-based laboratory, RDx Bioscience Inc. (RDX), and its owner and CEO, Eric Leykin, agreed to pay $10,315,023 to the US...more
Whenever new technologies emerge or new pots of government funds for assistance are available, you can count on one thing (as the sun rises and sets) – fraudsters will figure out a way to steal money from innocent persons and...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for April 2023. We discuss several criminal and civil enforcement actions related to the Anti-Kickback Statute (AKS) and the...more
The Federal False Claims Act (“FCA”) imposes civil liability for presenting a false claim to the government for payment. The Federal Anti-Kickback Statue (“AKS”) prohibits medical providers from making referrals in return for...more
The following is a summary of the federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are...more
The second quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several of $20 million or more. This post summarizes key settlements of interest to healthcare providers....more
A nationwide telemedicine kickback scheme led to fraudulent Medicare reimbursements for durable medical equipment and genetic testing. The full Department of Justice press release can be found here... ...more
The Department of Health and Human Services (DHHS) Office of Inspector General (OIG) announced yesterday a revamped hotline for reporting fraud, waste, abuse and mismanagement involving DHHS programs. ...more
In a bipartisan effort to combat the opioid crisis, H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the Act), was enacted on October 24,...more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
During the past nine months, the U.S. Department of Justice (DOJ) has made several significant policy pronouncements that impact health care organizations and individual providers. These directives and initiatives reflect...more
This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more
Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more
On October 19, 2015, the Department of Justice (DOJ), through the United States Attorney’s Office for the District of Massachusetts, announced that Millennium Health (formerly Millennium Laboratories) had agreed to resolve...more
Federal prosecutors have turned their attention to physicians for Medicare fraud prosecution. Physicians who participate in the Medicare program have to be aware of the significant risks of Medicare fraud....more
On June 18, 2015, the U.S. Department of Justice (DOJ), in collaboration with the U.S. Department of Health and Human Services (HHS), announced criminal charges against 243 individuals located in 14 states for various health...more