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
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
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
Hospital Executive and Three Physicians to Pay More Than $880,000 to Resolve Kickback Allegations - On Monday, December 4, 2023, a Lexington, Texas, hospital executive and three health care providers agreed to pay more...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
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
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
On June 9, 2017, the U.S. District Court for the District of Columbia denied a motion to dismiss brought by a laboratory in U.S. ex rel. Groat v. Boston Heart Diagnostics Corp., 2017 WL 2533341. Part of the grounds for...more