Division of Quality Assurance: Notifications & Updates
Attn: All Wisconsin Providers Performing COVID-19 Laboratory Testing
The Centers for Medicare & Medicaid Services (CMS) has issued this memorandum to provide important guidance for providers who want to perform COVID-19 testing and the CLIA certification requirements. This guidance is a part of the CMS effort to clarify:
- The types of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing and whether the tests are being offered under an Emergency Use Authorization (EUA) issued by FDA or as described in FDA’s COVID-19 Test Guidance
- The CLIA certifications under which each test can be performed
- An explanation of requirements under each testing scenario
- Information for Medicare beneficiaries on testing services and coverage
CMS has also issued a CLIA Frequently Asked Questions (FAQs) document for further guidance during the COVID-19 emergency.
For regulatory questions about CLIA Certification and COVID-19 testing please contact the Division of Quality Assurance (DQA) Licensing, Certification, and CLIA Section at DHSDQACLIA@wi.gov.
