CMS Issues More Guidance on Access to COVID-19 Antibody Treatment
The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibody therapy, bamlanivimab and etesevimab, administered together, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab, administered together, may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the Emergency Medical System (EMS), as necessary. Review the Fact Sheet for Health Care Providers EUA of Bamlanivimab and Etesevimab regarding the limitations of authorized use when administered together.
During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for these infusions the same way it covers and pays for COVID-19 vaccines (when furnished consistent with the EUA).
CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment: Eli Lilly and Company’s Antibody Bamlanivimab and Etesevimab, (ZIP) EUA effective February 9, 2021:
Q0245:
- Long descriptor: Injection, bamlanivimab and etesevimab, 2100 mg
- Short descriptor: Bamlanivimab and etesevima
M0245:
- Long Descriptor: Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring
- Short Descriptor: Bamlan and etesev infusion
Additional Resources: