New CMS temporary enforcement discretion allows clinical laboratories greater flexibility when applying for a CLIA Certificate of Waiver
The US Centers for Medicare and Medicaid Services (CMS) recently releasedfor clinical laboratories that have applied for a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver (CoW) and want to know at what point they can begin testing. This guidance applies specifically to the CMS-116 application for a CLIA Certificate of Waiver.
CMS provides guidance to clinical laboratories on this issue, stating, “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 … 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.”
CMS notes that this temporary enforcement discretion does not mean that normal CLIA requirements are being loosened outside this specific guidance. CMS also encourages laboratories to consider that their state agencies may have additional licensure requirements that must be met before they can begin testing.