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
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
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