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
We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
As we approach the Holiday Season, we all know that this is the time of year when gifts are exchanged. However, for health care providers, it can be a season of risk. Gifts to referral sources can cause unintended regulatory...more
The U.S. Attorney’s Office in Trenton, NJ announced on November 22 that primary care physician Yitzchok “Barry” Kurtzer of Monsey, NY, and his wife pleaded guilty to soliciting and receiving kickbacks and bribes in exchange...more
This opinion addresses a proposed agreement (“Proposed Arrangement”) between a national anatomic pathology laboratory (“Requestor”) and laboratories owned in whole or in part by physicians who may refer (“Referring...more
There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023. Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....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
After a rare False Claims Act (FCA) trial—especially one premised on violations of the Anti-Kickback Statute (AKS)—a federal jury in Minnesota returned a $43 million verdict against Precision Lens, a distributor of medical...more
On February 28, 2023, a federal jury in the District of Minnesota found the Cameron-Ehlen Group, d/b/a Precision Lens, and its founder and owner Paul Ehlen (the “Defendants”) guilty of paying kickbacks to ophthalmic surgeons...more
On February 27, 2023, a jury in Minnesota federal court rendered a verdict in favor of the United States and against a surgical product distributor following a False Claims Act jury trial that lasted six weeks. The jury...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
We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
Continuing its focus on healthcare technology and electronic health records (EHR) companies, the Department of Justice announced last month a $45 million settlement to resolve a False Claims Act suit involving EHR provider...more
The Justice Department continues to pile up healthcare enforcement actions — false claims, anti-kickback, and fraud. DOJ is on its way to a record year....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
Prosecutions related to the submission of claims to Tricare for compounded pain creams continue. The Eleventh Circuit Court of Appeals affirmed convictions against a Florida pharmacist, physician, and Navy veteran for their...more
After years of government skepticism and enforcement activity targeting physician-owned medical device companies, a recent favorable advisory opinion by the Office of Inspector General for the U.S. Department of Health &...more
On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for...more
The United States Court of Appeals for the Fourth Circuit recently affirmed a $114 million judgment in a protracted, and hotly contested, suit filed under the qui tam provisions of the False Claims Act (FCA) against the owner...more
America and France share many common ideals. The American Constitution is founded on the principle of government “of the people, by the people, and for the people.” The French Constitution embodies this same principle in the...more
A recent Eleventh Circuit opinion clarified the mens rea burden the Government must prove to establish criminal intent to violate the Federal Anti-Kickback Statute (“AKS”) for a recipient or payee of a kickback or bribe under...more
On August 6, 2020, the United States Court of Appeals for the Sixth Circuit upheld the conviction of a patient recruiter in a Medicare kickback case, finding insufficient evidence to demonstrate that the recruiter was a “bona...more
Before the government decides whether to intervene in a qui tam action, it is obligated by statute to investigate a whistleblower’s allegations. See 31 U.S.C §?3730(a). But, in the course of that investigation, may the...more
In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more
On April 11, 2019, in a federal court, a Dallas jury returned verdicts of guilty against seven of the defendants in the criminal case styled “United States v. Beauchamp” and commonly known as “Forest Park.” Of the original...more
Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act. While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more