CMS Lowers Barriers for Labs Seeking COVID-19 Test Certification
October 13, 2020The agency’s new guide aims to help laboratories reduce paperwork and streamline the CLIA certification application process, walking through the steps involved, including how to make sure the form is submitted to the correct state agency.
CMS said online payments for CLIA certification fees are processed overnight, a faster alternative to mailing checks. The platform is hosted by the Treasury Department on the CMS CLIA program website. The fees are based on the type of certificate requested and in some cases the annual volume and types of tests performed. The CLIA certificate fee schedule has cost information.
As the pandemic gained momentum in mid-March, FDA updated its earlier policy on COVID-19 testing to enable an expansion of testing capacity in the U.S. The guidance established a policy for states to take responsibility for authorizing tests developed and used by labs in their states. It also allowed for commercial manufacturers to distribute, and labs to use, new specimen tests developed before an emergency use authorization was granted.