Tag: covid-19
In the CY 2021 MPFS Proposed Rule, CMS solicited comments on whether the two specimen collection codes (G2023 and G2024), established during the COVID-19 PHE, should be deleted or should remain after the PHE has ended. These codes were created for in...
FDA continues to regularly update its FAQ regarding COVID-19 testing. In terms of EUAs, the FDA has issued 75 for commercial laboratories and/or manufacturer test kits. It has also issued 28 EUAs for high complexity, molecular based LDTs. Coronavir...
On May 8, 2020, the FDA issued its first Emergency Use Authorization for an antigen test for the diagnosis of COVID-19. This test is authorized in moderate and high complexity labs as well as at point-of-care testing. Coronavirus (COVID-19) Update: ...
The FDA announced today its issuance of an Emergency Use Authorization for its first laboratory diagnostic test using at-home collected saliva samples. Currently, this is the only authorized test using saliva samples. Coronavirus (COVID-19) Update:...
This afternoon, CMS published a second interim final rule on COVID-19 with some key changes in the lab / diagnostic space:
On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act represents the third largest stimulus bill passed by Congress in response to the COVID-19 pandemic and with $2 trillion in allocatio...
