Secretary Azar Issues Guidance for Hospitals on COVID-19 Test Reporting
During an early March American Health Lawyers Association webinar, the Office of General Counsel for the Department of Health and Human Services (HHS) reminded listeners that hospitals had reporting obligations for COVID-19 testing, although the OGC was uncertain to whom those reports were to be sent. AGG contacted OGC who informed us that guidance would be issued. On March 29, 2020, Vice President Pence sent a letter to hospital administrators requesting that all COVID-19 testing be reported to FEMA by email using a spreadsheet provided by FEMA. A form spreadsheet, which is available on the American Hospital Association website, provided hospitals with the data required to comply with Vice President Pence’s request for COVID-19 test reporting. Notwithstanding, HHS received pleas from hospitals and states to minimize the burden of sharing this data and particularly when such reporting would result in duplication of effort.
On April 10, 2020, Secretary Azar provided the requested additional guidance in the form of Frequently Asked Questions; acknowledged the duplication resulting from the reporting requests; and provided additional guidance on complying with the Federal Government’s request for COVID-19 test data. Secretary Azar noted that the Federal Government needed the data in order to facilitate the public health response to the 2019 Novel Coronavirus. Although Secretary Azar noted the burden on hospitals, the guidance provided that hospitals using in-house laboratories were required to report the requested data on a daily basis with certain exceptions.
Specifically, hospitals who report the requested data to the state may obtain a written release from the State, stating that the State will collect the data from the hospitals and thereby take over the Federal reporting responsibilities; provided the State receives written certification from their FEMA Regional Administrator that the State has an “established, functioning data reporting stream to the Federal Government that is delivering all the information below at the appropriate daily (or higher) frequency.”
Hospitals using in-house laboratories that are not located in states that have obtained the necessary certification may submit the data using TeleTrackingTM and must do so by 5 p.m. ET daily. Hospitals should have received a link to a hospital-specific secure form that can be used for reporting data. If not, hospitals are instructed to contact the FEMA/HHS COVID-19 Diagnostics Task Force. Requested data include the number of (1) New Diagnostic Tests Ordered; (2) Cumulative Diagnostic Tests Ordered; (3) New Tests Resulted; (4) Cumulative Tests Performed; (5) New Positive COVID-19 Tests; (6) Cumulative Positive COVID-19 Tests; (7) New Negative COVID-19 Tests; and (8) Cumulative Negative COVID-19 Tests.
Hospitals that send all their COVID-19 tests to commercial laboratories to include LabCorp, BioReference Laboratories, Quest Diagnostics, Mayo Clinic Laboratories, ARUP Laboratories and Sonic Healthcare, or to State Public Health Laboratories are not required to report those tests.