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CMS Releases New and Modified CLIA Requirements and Penalties for Noncompliance

Requirements around COVID-19 testing

Clinical laboratories face new reporting requirements and penalties for noncompliance with CMS-3401-IFC which was released Aug. 25.

The Centers for Medicare and Medicaid Services (CMS) released an interim final rule (CMS-3401-IFC) changing CLIA requirements for clinical laboratories. This new interim final rule also addresses long-term care facilities’ COVID-19 reporting and testing requirements.

CMS-3401-IFC key changes impacting clinical laboratories, according to CMS, include:

  • CLIA regulations have been updated to require all laboratories to report SARS-CoV-2 test results in a standardized format and at a frequency specified by the Secretary [of Health and Human Services]; and
  • Failure to report SARS-CoV-2 test results will result in a condition-level violation of the CLIA regulation and may result in the imposition of a civil money penalty (CMP).

The new guidance states, “All CLIA-certified laboratories that perform or analyze any test that is intended to detect SARS- CoV-2 or to diagnose a possible case of COVID-19 (e.g., molecular, antigen, antibody) are required to report, regardless of the type of laboratory (type of CLIA certificate) performing the testing.”

CMS goes on to say, “All negative and positive SARS-CoV-2 results must be reported irrespective of the method (e.g., molecular, lateral flow) used. Molecular (RT-PCR) tests detect the virus’s genetic material and antigen tests detect specific proteins on the surface of the virus.” The August 2020 interim final rule also specifies that it applies to point of care (POC) diagnostic testing.

CMS will impose a civil money penalty for labs that are not compliant—$1,000 for the first day of noncompliance with the new reporting requirements, and $500 for each subsequent day the laboratory fails to report SARS-CoV-2 test results, according to the interim final rule.

Clinical laboratories should review the full text of these new guidelines to ensure compliance with the new requirements.

Related Resources:

CMS Announcement: Interim Final Rule (IFC), CMS-3401-IFC, Updating Requirements for Reporting of SARS-CoV-2 Test Results by (CLIA) of 1988 Laboratories, and Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency

Interim Final Rule (IFC), CMS-3401-IFC: Full Text