Employment Law Report

On May 26, 2021, the FDA released an Emergency Use Authorization (EUA) for sotrovimab.  In response, on February 17, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it had created a new HCPCS code, effective May 26, 2021, for sotrovimab when administered in a healthcare setting or the home in accordance with the FDA Fact Sheet for Healthcare Providers on EUA of sotrovimab. 

As we previously reported, CMS had previously announced that Medicare will cover Regeneron’s COVID-19 monoclonal antibody combination casirivimab & imdevimab product when administered for qualifying patients.  On June 3, 2021, the FDA released a revised EUA for this Regeneron monoclonal antibody combination product. The updated EUA includes a new dosing regimen (1200 mg vs. 2400 mg) and allows a new route of administration. In response to this change, CMS created a new HCPCS code, effective June 3, 2021, and updated the short and long code descriptors for 2 codes.  See the updated FDA Fact Sheet for Healthcare Providers on the EUA of casirivimab & imdevimab.

See the CMS MLN Newsletter dated June 17, 2021, for additional details from CMS on descriptors for the above two new HCPCS codes.  Go to the CMS webpage, Monoclonal Antibody Products to Treat COVID-19, to stay abreast of Medicare coverage of these treatments.