FDA Updates Policy about Serology Tests for COVID-19, CDC Posts New Information about Serology Testing for COVID-19, and more

COLA engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. Below are links to the most recent messages with FDA policy updates on serology tests for COVID-19, CDC updated information on serology testing for COVID-19, and updated CDC COVID-19 frequently asked questions about Medicare fee-for-service billing.

FDA Updates Policy about Serology Tests for COVID-19

On May 4, 2020, the U.S. Food and Drug Administration (FDA) released a revised policy for COVID-19 testing during the public health emergencyexternal icon. In particular, this policy outlined new expectations for serology test developers:

Read more here. 

CDC Posts New Information about Serology Testing for COVID-19

CDC recently posted a new web page to provide information about the CDC serology (antibody) test for coronavirus disease (COVID-19). This test has been validated for surveillance and research purposes to support the CDC surveillance strategy for the pandemic response.

Read more here. 

CMS Issues Updated COVID-19 Frequently Asked Questions about Medicare Fee-for-Service Billing

CMS recently issued updated frequently asked questions(FAQs) about Medicare fee-for-service billing  during the COVID-19 public health emergency (PHE).

Read more here.