CMS Streamlines CLIA’s Clinical Lab Certification Process for COVID-19 Testing

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Arent Fox

On September 25, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it streamlined the federal Clinical Laboratory Improvement Amendments (CLIA) certification process for laboratories applying to perform COVID-19 testing.

Under CLIA, all laboratories in the United States must hold a CLIA certificate before performing testing on human samples for diagnosis, prevention, or treatment. To assist laboratories seeking certification to provide COVID-19 testing, CMS released a “quick start guide” outlining the CLIA certification process. Laboratories can pay CLIA certification fees online through the CMS CLIA website.

The quick start guide provides detailed instructions for completing CMS-Form 116, the CLIA laboratory certification form, and information regarding the applicable state agencies administering the CLIA program. The quick start guide also reinforces CMS’s commitment to an expedited review of CLIA applications for COVID-19 testing. It reiterates that laboratories may begin testing upon assignment of a CLIA number, provided that applicable CLIA requirements are met. This position is consistent with prior CLIA guidance released by CMS in March 2020 at the start of the pandemic. Laboratories should be aware, however, that some states may have additional licensing requirements that must be met before testing can begin.

Links to the referenced documents are below:

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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