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

Title
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
Memo #
QSO-20-37-CLIA,NH
Posting Date
2020-08-26
Fiscal Year
2020
Summary
 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.