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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
CMS is committed to taking critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). On August 25, 2020, an interim final rule with comment period (IFC) 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 may result the imposition of a Civil Money Penalty (CMP) as required under §§ 493.1804 and 493.1834. Long-Term Care (LTC) Enforcement requirements at 42 CFR part 488 have been revised to include requirements specific to the imposition of a CMP for nursing homes that fail to report requisite COVID-19 related data to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) per §483.80(g)(1) and (2). LTC Facility Testing Requirements for Staff and Residents- Facilities are required to test staff and to offer testing to all nursing home residents.