The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
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
On July, 11, 2025, the Ninth Circuit Court of Appeals affirmed laboratory operator Mark Schena’s conviction under Eliminating Kickbacks in Recovery Act (EKRA). This is the first time a higher court has addressed the lab...more
In a qui tam action filed under the False Claims Act, the relator, Barbara Senters, appealed the district court’s dismissal of her fourth amended complaint (FAC), which alleged that Quest Diagnostics submitted false claims...more
As Holland & Knight previously reported, since its enactment in 2018, the Eliminating Kickbacks Recovery Act (EKRA) has been a source of anxiety and confusion for the clinical laboratory and behavioral health industries in...more
On July 11, 2025, the Ninth Circuit issued a decision clarifying the scope of Eliminating Kickbacks in Recovery Act (EKRA). In affirming a Northern California-based medical testing laboratory’s convictions under EKRA, the...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
Similar to other types of healthcare entities, clinical laboratories have been facing enhanced scrutiny from federal authorities over the past couple of years. While this is due in part to fraud concerns related to COVID-19...more
In late December, the U.S. Circuit Court of Appeals for the Eleventh Circuit issued its decision in Yates v. Pinellas Hematology & Oncology, P.A. The appellate court affirmed the district court’s imposition of damages and...more
A False Claims Act case can easily turn into a criminal prosecution. The Federal Bureau of Investigation often initiates criminal investigations as part of its commitment to reducing health care fraud....more
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
Defense Vehicle Manufacturer Accused of Defrauding the Government by $1.2 Billion - On Tuesday, December 3, the United States District Court for the District of Columbia unsealed a six-year-old False Claims Act complaint...more
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