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 tragedy of the COVID-19 pandemic is something we all agree we wish we could have avoided. However, the fact of the matter is that many respiratory and clinical labs have seen a boon to their bottom line due to the...more
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
In an unprecedented move touted as necessary to address the COVID-19 testing shortage, the U.S. Department of Health and Human Services (HHS) made a brief statement on August 19 that effectively rescinded the federal Food and...more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
On June 23, 2020, the US Departments of Labor, Health and Human Services, and Treasury issued tri-agency FAQs (Part 43) that clarify important health and welfare provisions under the Families First Coronavirus Response Act...more
On June 4, 2020, HHS released new guidance detailing what additional data laboratories must report to HHS along with COVID-19 test results. HHS explained that the new guidance standardizes reporting requirements in an effort...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