Tag: covid-19

CMS solicits comments on specimen collection codes and proposes conforming regulatory changes for PAMA in CY 2021 MPFS Proposed Rule

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 updated its FAQ document

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...

FDA approves the first antigen test for diagnosing COVID-19

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: ...

FDA approves the first diagnostic test using at-home saliva collection

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:...

CMS released a second Interim Final Rule on COVID-19 with additional waivers, giving more flexibility to providers

This afternoon, CMS published a second interim final rule on COVID-19 with some key changes in the lab / diagnostic space:

  • Requirement that the test be ordered by a treating physician or nurse practitioner has been removed
  • COVD-...

    Congress passes CARES Act

    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...