Bamlanivimab/Etesevimab Use and Inventory Fields Added to HHS Mandatory Reporting; Info on COVID-19 NY Variant and Monoclonal Antibody Therapy

March 22, 2021

The Department of Health and Human Services (HHS) released updated guidance on COVID-19 TeleTracking reporting, introducing new fields for bamlanivimab/etesevimab use and on-hand supply. Hospitals can opt to submit the new fields on Wednesdays, starting March 24. The fields will be required beginning April 7. The guidance also makes the reuse of personal protective equipment field optional.. Also, vaccine questions are adjusted to reflect single-dose or multiple-dose shots.

Hospitals are required to report certain data elements related to the COVID-19 public health emergency as a Condition of Participation in the Medicare program, as described in the Centers for Medicare & Medicaid Services’ September interim final rule with comment period. This requirement is met by reporting data to TeleTracking. We encourage you to review TeleTracking’s release notes and the updated template for those using .CSV file upload.

Information on COVID-19 New York Variant and Monoclonal Antibody Therapy

The Office of the Assistant Secretary for Preparedness and Response (ASPR) released important information via e-mail (attached) regarding monoclonal antibody therapies, antiviral resistance, and COVID-19 variants. Of particular concern, the “New York” variant B.1.526 (with E484k) has reduced susceptibility to monotherapy (i.e., bamlanivimab alone). We strongly encourage hospitals to review the new information regarding the New York variant and resistance to bamlanivimab.

The Food and Drug Administration has authorized the emergency use of bamlanivimab and etesevimab to be administered together. Etesevimab can be direct ordered alone to supplement existing bamlanivimab supplies. These drugs remain free-of-charge. Please see ASPR’s factsheet for instructions on ordering.

For issues with accessing the TeleTracking portal, please contact TeleTracking Technical Support at (877) 570-6903.

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