Clarification on Antigen Test Reporting Requirements

Several members have recently contacted us about whether there is a continuing requirement to report negative COVID antigen test results to NHSN.  In North Carolina, there is such a requirement for now.  That is set to change on October 1, 2022.  Background follows. 

Effective April 4, 2022, the U.S. Department of Health and Human Services (HHS) updated its Laboratory Data Reporting Guidance to provide that COVID-19 testing facilities are “no longer required to report NEGATIVE results for tests authorized for use under a CLIA certificate of waiver. This includes rapid and antigen testing performed for screening testing at schools, correctional facilities, employee testing programs, long-term care facilities, and rapid testing performed in pharmacies, medical provider offices, and drive-through and pop-up testing sites. In addition, testing facilities are no longer required to report POSITIVE or NEGATIVE antibody test results.”  This changed guidance replaced the prior requirement to report all SARS-CoV-2 test results.  

Shortly thereafter, AHCA confirmed with HHS and CMS that there is no more federal requirement to report negative results for antigen tests and there is no longer any reporting requirement for antibody testing.  Members do still have to report positive antigen results through the NHSN portal, as well as positive or negative PCR test results.    

The state of North Carolina, however, adopted a rule in 2020, which remains in effect, that requires the reporting of negative antigen tests to the Division of Public Health, which is satisfied by reporting to NHSN.  Once federal requirements changed in April, through our outside counsel, NCHCFA requested a waiver by the Secretary of the portion of the NC rule that relates to the reporting of negative test results to the Division of Public Health so that the NC rule would be consistent with the updated HHS guidance.  NC DHHS believes it does not have the authority to waive this rule.  We have learned that the Division of Public Health is not prioritizing the reporting of the negative results in an attempt to lighten the burden on labs and SNFs, given the change in federal guidance.  But, that rule remains on the books and is enforceable.   

With our encouragement, the NC Commission for Public Health (CPH), has started the process to amend the NC rule to mirror the federal rule.  We anticipate the NC rule will be fully updated effective October 1, 2022.  Here is more information on the pending change and the rulemaking timeline on the CPH website:  https://cph.dph.ncdhhs.gov/Rules/EpiHealth/10A-NCAC-41A.0107-DiagnosticTestResults.htm  Please contact the Association if you have any questions.