News & Analysis as of

Department of Justice (DOJ) Clinical Laboratory Testing Enforcement Actions

Pietragallo Gordon Alfano Bosick & Raspanti,...

Rare Circuit Court Decision on Eliminating Kickbacks in Recovery Act Demands Notice In and Beyond Addiction Treatment Industry

The Ninth Circuit recently decided United States v. Schena, 142 F.4th 1217 (9th Cir. 2025), which considered the Eliminating Kickbacks in Recovery Act (“EKRA”). EKRA, enacted in 2018 to address “body brokering” and other...more

Alston & Bird

DOJ Settles Cyber Qui Tam Action Against Illumina for Allegedly Unsecured Genomic Sequencing Products

Alston & Bird on

On July 31, 2025, the United States Department of Justice (DOJ) announced a $9.8 million settlement with Illumina, Inc. (Illumina) to resolve alleged False Claims Act (FCA) violations related to cybersecurity vulnerabilities...more

Bricker Graydon LLP

DOJ announces $22 million False Claims Act settlement with the University of Miami for provider-based and lab billing issues

Bricker Graydon LLP on

On May 10, 2021, the Department of Justice (DOJ) announced a $22 million settlement with the University of Miami (UM) to resolve allegations related to improper billing for off-campus provider-based facilities, medically...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement Spotlight: US Prosecutors Continue To Target Medical Technology Companies

Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more

The Volkov Law Group

Department of Justice Brings Criminal Charges Against 35 Individuals for Involvement in $2.1 Billion in Fraudulent Genetic Testing...

The Volkov Law Group on

The Justice Department, in coordination with HHS-OIG and the FBI recently announced the arrest and prosecution of 35 individuals for a massive genetic testing fraud scheme involving dozens of telemedicine companies and cancer...more

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