What started as the traditional Emergency Use Authorization (EUA) response deployed by the FDA for previous infectious illness outbreaks has rapidly evolved into something altogether different and … [Read more...]
FDA Watch
The Month in Global New Diagnostic Test Approvals
April 7, 2020
In addition to Emergency Use Authorization clearances for 15 COVID-19 tests, the FDA cleared a number of other non-coronavirus tests via its standard pathways. Here’s the rundown of key new approvals … [Read more...]
Employment Law
Coronavirus pushing rapid changes in employer law
March 30, 2020
By Mike O’Brien bio Employer law is rapidly changing amid the coronavirus pandemic. For one thing, Congress has passed another coronavirus related law. The United States Department of Labor (DOL) … [Read more...]
Industry Buzz
COVID-19 Relief Bill Leaves Labs Out in the Cold
March 30, 2020
Labs who have answered the call to mobilize beyond capacity so that people can be tested for COVID-19 can be forgiven for thinking nobody in Washington “CARES” about them. What else are they supposed … [Read more...]
Daily Update
FDA Approved Coronavirus Tests
March 30, 2020
COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION (As of April 2, 2020) Yesterday, North Carolina-based Cellex’s qSARS-CoV-2 IgG/IgM Rapid Test became the first coronavirus serology … [Read more...]
Reimbursement
CDC Issues ICD-10-CM Coding Guidance for Coronavirus Encounters
March 28, 2020
The U.S. Centers for Disease Control and Prevention (CDC) issued official guidance to labs and other health care providers on which ICD-10-CM diagnosis codes to use for 2019 novel coronavirus … [Read more...]
