Has the FDA revoked its EUA for Bamlanivimab when administered alone?
Yes. On April 16, 2021, the FDA revoked its Emergency Use Authorization (EUA) for Bamlanivimab when administered alone. Per the FDA news release linked below, this decision was rooted in the rise of COVID-19 variants and clinical data which suggests Bamlanivimab is not effective in treating these new variants when administered alone. The FDA will continue to allow Bamlanivimab to be administered in conjunction with Estesevimab for the treatment of mild to moderate COVID-19 in patients who are at risk for progressing to severe COVID-19 and/or hospitalization.
In a subsequent MLN Special Edition bulletin published on April 20, 2021, CMS states “Medicare will cover and pay for Bamlanivimab, when administered alone, for dates of service from November 10, 2020 – April 16, 2021”. As reference, Bamlanivimab, when administered alone, should have been reported with the HCPCS codes noted below.
Q0239 Injection, bamlanivimab-xxxx, 700 mg
M0239 Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring
Hospitals should ensure their clinical, chargemaster, and billing staff are made aware of this update.
FDA News Release, “Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab”:
CMS MLN Special Edition, “COVID-19 Update: FDA Revoked the EUA for Bamlanivimab When Administered Alone”: