Updated on 03/14/2022

COVID-19 Monoclonal Antibodies: Revised Emergency Use Authorization for EVUSHELD

On February 24, the FDA revised the emergency use authorization for tixagevimab co-packaged with cilgavimab (EVUSHELD™) to change the initial dose for the authorized use as pre-exposure prophylaxis of COVID-19 in certain adults and pediatric patients. For more information about dosage and administration, including information about dosing for patients who got the original lower dose, review the fact sheet (ZIP).

CMS created new code, Q0221, effective February 24:

  • Long Descriptor: Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), 600 mg
  • Short Descriptor: Tixagev and cilgav, 600mg

Use the existing administration codes — M0220 and M0221.

 

Article published by CMS on March 10, 2022
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