In COVID-19

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.

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