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CMS Issues Updated Rules for CLIA Labs and NFs with CLIA Waivers

Last updated on 8/31/2020

The Centers for Medicare & Medicaid Services (CMS) released QSO-20-37-CLIA, NH (PDF). The memo informs Clinical Laboratory Improvement Amendment laboratories and nursing facilities about the following:

  • On August 25, 2020, an interim final rule with comment period went on display at the Federal Register.
  • 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.
  • Failure to report SARS-CoV-2 test results will result in a condition level violation of the CLIA regulation and can result in the imposition of a Civil Money Penalty as required under Code of Federal Regulations §§ 493.1804 and 493.1834.
  • Long-Term Care Enforcement requirements at 42 CFR part 488 have been revised to include requirements specific to the imposition of civil money penalties for nursing homes that fail to report requisite COVID-19 related data to the Centers for Disease Control and Prevention National Healthcare Safety Network per §483.80(g)(1) and (2).

Health-care facilities using Point of Care COVID-19 testing devices under a CLIA Certificate of Waiver, including NFs, pharmacies, or other settings will be required to report test results under this regulation.