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
Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more
Laboratory testing is a key factor in identifying or diagnosing COVID-19 patients, including during the asymptomatic phase, and determining appropriate treatment. With respect to COVID-19, laboratory testing is also critical...more
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more
On April 14, 2020, CMS released a ruling that will increase the reimbursement for tests conducted to detect SARS–CoV–2 (the diagnosis of the virus that causes COVID–19) for tests utilizing “high throughput technologies.”...more
Several of the provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed by the Senate on March 25 relate to laboratory diagnostic testing for the COVID-19 virus....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
Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more