COVID-19 Guidance & Updates - March 19, 2020
 
Please read below for COVID-19 related guidance on CPT Coding and FDA Testing:



FDA Expands Testing Capabilities:
On Monday night, FDA Commissioner Hahn announced that states can set up their own system in which they take responsibility for authorizing such tests and the laboratories will not need to engage with the FDA to conduct COVID-19 testing. The updated guidance also expands the types of labs that can conduct testing and provides recommendations for test developers who are interested in developing a test. The FDA has established 1-888-INFO-FDA, to help labs with any questions they may have about the Emergency Use Authorization process, FDA policies or getting supplies. Similar to approving Roche testing last week, yesterday, the FDA also issued Emergency Use Authorizations (EUAs) to Hologic and LabCorp for their tests. 

Ed Heidig
Region IX Director
U.S. Department of Health & Human Services