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 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 Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion highlighting two important—if easy to overlook—areas that health care companies and providers should remain...more
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...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 Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a...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
Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...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