Centers for Medicare & Medicaid Services. (2020). Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Authorized Laboratories. U.S. Department of Health and Human Services.
This memorandum provides information about the availability of a diagnostic test for Covid-19 under an emergency use authorization (EUA). It provides guidance to surveyors to notify CMS of laboratories using an assay without an EUA or a modified EUA.