PARA Weekly eJournal: October 13, 2021
BAMLANIVIMAB AND ETESEVIMAB FOR COVID-19 RESUMES
In a letter dated September 16, 2021, the FDA announced a revision to the Emergency Use Authorization (EUA) on the COVID-19 monoclonal antibody drug combination bamlanivimab and etesevimab.Distribution and use of this therapy, was paused on June 25, 2021 while additional clinical trials were conducted.After collecting and evaluating data, the FDA declares all states may resume the administration to patients being treated for COVID-19 in accordance with EUA 094. This letter may be downloaded from the following site: https://www.fda.gov/media/145801/download
Medicare will cover monoclonal drugs, when not provided free of cost, at reasonable costs in an outpatient hospital and may base physician office payments on average wholesale price.Medicare will pay for the monoclonal infusions, when administered in accordance with the EUA, under the vaccine program.
PARA offers additional COVID-19 billing and coding guidance through our ?COVID-19 Comprehensive Billing & Coding? publication. 5