New COVID-19 Reporting Requirement for CLIA Labs

On August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a new Interim Final Rule (IFR) that establishes new requirements for laboratories to submit daily reports on COVID-19 test results to the Secretary of the United States Department of Health and Human Services (HHS).  HHS is to issue further guidance on the form and manner of reporting.  All laboratories conducting COVID-19 testing and reporting patient-specific results – including hospital labs, nursing homes, and other facilities conducting testing for COVID-19 – will be required to comply.  The requirement will apply only to CLIA-certified labs, i.e., labs that are subject to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). 

The IFR allows CMS to take enforcement action against laboratories that fail to provide the required data.  Specifically, if a laboratory does not report the required information, CMS will impose a civil monetary penalty in the amount of $1,000 a day for the first day, and $500 for each subsequent day.  Labs will have a one-time, three-week grace period to begin reporting the required test data. This new requirement supplements existing HHS guidance that had instructed laboratories to report test results and additional information, such as demographic data.  CMS states that this reporting is needed by federal, state, and local officials to conduct effective surveillance of the COVID-19 pandemic.  As set forth in further detail in the IFR, based on the Public Health Emergency (PHE), CMS is waiving both the notice and comment period and the 30-day delay in the effective date and making the new reporting requirements effective on the date the IFR is published (which is expected any day). The reporting requirement will continue in effect through the COVID-19 PHE.