HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
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
In a cautionary tale for health care entities, the U.S. Attorney’s Office for the Eastern District of North Carolina recently announced the convictions of two health care executives who admitted to orchestrating a multi-year...more
Texas AG Ken Paxton has sued pharmaceutical manufacturer Eli Lilly for allegedly bribing and illegally inducing medical providers to prescribe and continue prescribing several Lilly drugs—including GLP-1 medications Mounjaro...more
The federal government has demonstrated that it is more than willing to use the United States criminal code to prosecute home care agencies that pay unlawful financial inducements to generate referrals in violation of the...more
On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more
In a matter of first impression, the Ninth Circuit Court of Appeals interpreted the scope of the 2018 Eliminating Kickbacks in Recovery Act (EKRA) in the context of a lab operator who allegedly paid marketers to induce...more
The False Claims Act continues to be one of the most commonly used weapons in the government’s enforcement arsenal to address various forms of fraud. In addition to our “Year in Review” publication providing an overview of...more
New York AG Letitia James, along with a bipartisan coalition of 48 other AGs and in coordination with the U.S. DOJ, announced a $202 million settlement in principle with Gilead Sciences, Inc. (“Gilead”), to resolve...more
On June 6, 2025, the Office of Inspector General (OIG) issued Advisory Opinion 25-03 (the “Opinion”), offering guidance for structuring telehealth collaborations in a manner that complies with the federal Anti-Kickback...more
The Office of Massachusetts Attorney General (AG) Andrea Campbell announced the criminal indictment of several Massachusetts-based health care providers and their owners in connection with allegedly false claims they...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
In United States v. Regeneron Pharmaceuticals Inc., the US Court of Appeals for the First Circuit held that when the government seeks to establish False Claims Act liability under the 2010 amendment to the Anti-Kickback...more
Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims - Last week, the Second Circuit Court of Appeals affirmed the district court’s ruling that dismissed allegations from a whistleblower who claimed that...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
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
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
Federal Court Permits Investors to Resume Kickback Suit Against Teva - After a two-year long stay, on August 30, Judge Karen S. Marston of the US District Court for the Eastern District of Pennsylvania ruled that investors...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
The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community...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
Below are noteworthy False Claims Act (FCA) decisions from the third quarter of 2023. The main issues in the cases are: Materiality. The Fourth Circuit held that a pharmacist’s efforts to falsify patient eligibility...more
Walgreens Medicaid Fraud Case Kicked Back to Trial Court - On August 15, 2023, the US Court of Appeals for the Fourth Circuit issued an opinion reversing a district judge’s dismissal of False Claims Act (FCA) claims...more
In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...more
Recent Interview With FCA Plaintiff Bar Attorneys Offers Key Insight into Trends in Anti-Kickback Litigation - During a recent interview commemorating the 50th anniversary of the enactment of the Anti-Kickback Statute, two...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
There are multiple components to the risk defendants must consider when faced with going to trial for a matter involving the False Claims Act (FCA). Setting aside the incalculable impact that litigation can have on business...more