New CLIA certification guidance for SARS-CoV-2 testing provided by CMS in 20-06-CLIA
On April 30, 2020, the Centers for Medicare and Medicaid Services (CMS) released a memorandum providing guidance for laboratories in understanding the Clinical Laboratory Improvement Amendments (CLIA) certifications required by laboratories to perform SARS-CoV-2 testing. CMS reminded labs that CLIA certification is needed to perform SARS-CoV-2 testing, even by entities not traditionally considered labs. CMS also reaffirmed its commitment to ensuring that labs are able to respond to the COVID-19 pandemic and other respiratory illnesses.
This memo, ADMIN 20-06-CLIA, is intended to clarify:
- Types of SARS-CoV-2 testing
- If SARS-Co SARS-CoV-2 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
- The requirements of each testing scenario
- SARS-CoV-2 testing services and coverage for Medicare beneficiaries
CMS explains the CLIA certifications under which tests can be performed, and testing requirements for each test, based on if the SARS-CoV-2 test is a test kit or a lab developed test (LDT).
- Test kits authorized under EUA for point-of-care (deemed waived) may be performed under all CLIA certificate types. Testing must be performed as per Manufacturer’s Instruction (MI), and quality control must be performed per MI. There are no personnel requirements.
- Test kits authorized under EUA for high and/or moderate complexity may be performed under a Certificate of Compliance or a Certificate of Accreditation. Testing must meet requirements for Moderate or High Complexity Testing, depending upon test complexity or setting, as authorized in EUA.
- Test kits for which the laboratory or manufacturer has notified FDA as described in FDA’s COVID-19 Test Guidance and is listed on the FDA website, but the test is not FDA authorized under EUA may be performed under a Certificate of Compliance or a Certificate of Accreditation. These tests must meet requirements for High Complexity Testing (regardless of whether manufacturer intends for test to be point-of-care/waived).
- LDTs authorized under EUA can be performed under a Certificate of Compliance or a Certificate of Accreditation. These tests must meet requirements for High Complexity Testing.
- LDTs for which the laboratory or manufacturer has notified FDA as described in FDA’s COVID-19 Test Guidance and is listed on the FDA website, but the test is not FDA authorized under EUA. These tests may be performed under a Certificate of Compliance or a Certificate of Accreditation, and they must meet requirements for High Complexity Testing.
- LDTs authorized by State Authority through a State Approved Program may be performed under a Certificate of Compliance or a Certificate of Accreditation. These tests must meet requirements for High Complexity Testing.
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