Attn: All Regulated Health Care
Important Message from CMS: SARS-CoV-2 Point of Care Testing and CLIA Certificate of Waiver Applications
The Centers for Medicare & Medicaid Services (CMS) has asked state agencies to share the following information with any entity that may perform COVID testing under a CLIA Certificate of Waiver (CoW); the pressing need currently is Assisted Living providers. The SARS-CoV-2 Point of Care Testing and CLIA Certificate of Waiver Applications document indicates the following:
* Question: My facility has submitted a CMS-116 application for a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver (CoW) to perform Point of Care (POC) SARS-CoV-2 testing authorized by the Food and Drug Administration (FDA) to be performed in a waived setting. When am I able to begin testing?
* Answer: In order to perform SARS-CoV-2 POC testing and report patient-specific results, a facility must be a CLIA-certified laboratory or testing site that meets applicable regulatory requirements.
CMS is temporarily exercising enforcement discretion under CLIA for SARS-CoV-2 POC testing when a facility has submitted a CMS-116 application for a CLIA CoW, but has not yet been assigned a CLIA number. Specifically, facilities that have applied for a CLIA CoW to perform SARS-CoV-2 POC testing (as indicated on section VI of the submitted CMS-116) can begin SARS-CoV-2 POC testing and reporting patient-specific results as soon as they have submitted their application to their State Agency (SA).
A non-certified facility will be treated as operating under CoW while their application is being processed. Facilities that have submitted a CMS-116 application for a CLIA CoW should check with their State Agency before they begin testing as states may have additional licensure requirements that must be met before testing can begin.
Please contact the Division of Quality Assurance at DHSDQACLIA@wisconsin.gov with questions.
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