CMS doesn’t want the usual compliance red tape to stand in the way of desperately needed COVID-19 testing. So, on May 1, the agency issued regulatory waivers temporarily expanding coverage of testing … [Read more...]
Focus On
Nearly 3 in 4 Physicians Say They Can’t Provide Easy & Rapid COVID-19 Testing
April 17, 2020
Development of new lab tests to detect the SARS-CoV-2 virus that causes COVID-19 coronavirus has been faster and more prolific than anybody could dare expect for a pathogen that was unknown just a few … [Read more...]
The Coronavirus Crisis
Test-Now, Regulate-Later Strategy Generates Robust Dx Test Pipeline in Record Time
April 17, 2020
Historically, the lag between Public Health Emergency (PHE) declaration and FDA approval of a lab test to diagnose the pathogen has been a minimum of eight weeks. Eight weeks into the coronavirus PHE, … [Read more...]
LDTs
VITAL Act Would Eliminate FDA Regulation of New Tests During Health Emergencies
April 13, 2020
In standing aside and allowing test makers to validate and perform COVID-19 laboratory developed tests (LDTs) and not wait for Emergency Use Authorization (EUA), the FDA has actually acknowledged what … [Read more...]
Reimbirsement
Congress Calls on Insurers to Cover Coronavirus Testing without Charging Patients
March 30, 2020
As labs scramble to come up with a coronavirus detection assay and CMS creates a billing and coding regimen, Congress is working to ensure that private payors provide coverage of SARS-CoV-2 testing. … [Read more...]
ACLA
Lab industry leaders meet with White House on COVID-19 testing
March 8, 2020
The American Clinical Laboratory Association (ACLA) has issued a statement following a meeting last week with the White House's Coronavirus Task Force. Here is a statement from ACLA President Julie … [Read more...]
Coronavirus
Two commercial labs testing now for COVID-19
March 8, 2020
Two commercial lab companies have announced they are moving into testing for COVID-19. LabCorp. said Thursday it was immediately offering testing for COVID-19 and Quest Diagnostics has announced it … [Read more...]
CLIA: CMS Issues Guidance on How Labs Should Perform Coronavirus Testing
February 27, 2020
On Feb. 6, CMS issued guidance to labs and other providers on how to use the newly approved Centers for Disease Control and Prevention (CDC) test for coronavirus. Here are the key takeaways. The … [Read more...]
Coronavirus
Special Report: FDA to Use EUA Pathway to Clear New Coronavirus Tests
February 25, 2020
The 2019 novel Wuhan coronavirus outbreak caught regulators and diagnostic test makers off guard. As the death toll mounts, the scramble is on to develop tests capable of detecting the virus. Here’s a … [Read more...]
FDA Watch
Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
January 30, 2020
There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]
