Dive Brief:
- CMS on Friday issued a guide to revised procedures designed to help speed the process for laboratories to obtain Clinical Laboratory Improvement Amendments certification to test for the novel coronavirus.
- An accelerated review process implemented early in the pandemic lets labs begin COVID-19 testing before they've received their official paper certificate by mail. Another change is the availability of online payment for CLIA certification fees.
- Providing the how-to guide to CMS CLIA certification and information on the expedited review process is part of the federal government's effort to expand testing during the public health emergency, the agency said.
Dive Insight:
CMS derives its authority to regulate all testing, barring research, via CLIA. The objective of the program is to ensure quality laboratory testing and that all clinical labs are properly certified to receive Medicare or Medicaid payments. However, the CLIA certification process can be time-consuming.
"An obscure process and outdated modes of payment have too often caused needless delays in certifying lab testing facilities," CMS Administrator Seema Verma said in a statement. The new tools "will allow testing laboratories to promptly and painlessly register with CMS so they can get to work, focusing on providing reliable information to combat the spread of this disease," she said.
The 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.
