CMS Halts Medicare Payment for Bamlanivimab When Administered Alone to Treat COVID-19

On April 20, 2021, Medicare announced that it will cover and pay for bamlanivimab, when administered alone, only for dates of service from November 10, 2020 to April 16, 2021.  This change in payment policy was to align with the FDA announcement on April 16, 2021, that it had revoked the Emergency Use Authorization (EUA) for bamlanivimab, when administered alone, due to a sustained increase in COVID-19 viral variants in the U.S. that are resistant to this antibody therapy. The FDA determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks.

The FDA indicates that alternative monoclonal antibody therapies remain appropriate to treat COVID-19 patients, and health care providers may continue using these authorized therapies when administered together:

• Casirivimab & imdevimab
• Bamlanivimab & etesevimab

As we previously reported, CMS earlier announced that Medicare will cover the above two combination monoclonal antibody infusion therapies for qualifying patients.  CMS has not changed its payment policy for these two combination treatments as long as they are used in accordance with the FDA Fact Sheets:

• FDA Fact Sheet for Health Care Providers EUA of Casirivimab and Imdevimab Section 15, Antiviral Resistance
• FDA Fact Sheet for Health Care Providers EUA of Bamlanivimab and Etesevimab Section 15, Antiviral Resistance

In addition, CMS states that providers can order etesevimab alone to pair with their current supply of bamlanivimab.  For more coverage and coding information, see the CMS Monoclonal Antibody COVID-19 Infusion webpage.