COVID-19 | Alpha II

FDA Revokes EUA of Monoclonal Antibodies and Administration for EVUSHELD (HCPCS Codes Q0220, Q0221, M0220, M0221)

Written by Stacey LaCotti | Feb 6, 2023 1:00:00 PM

On January 6, 2023, the Food and Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) for the monoclonal antibodies COVID-19 treatment EVUSHELD (Tixagev and cilgav).

The affected codes are:

  • HCPCS Code Q0220: Tixagev and cilgav, 300mg
    • 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), 300 mg
  • HCPCS Code Q0221: Tixagev and cilgav, 600mg
    • 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
  • HCPCS Code M0220: Tixagev and cilgav, inj
    • 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), includes injection and post administration monitoring
  • HCPCS Code M0221: Tixagev and cilgav inj hm
    • 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), includes injection and post administration monitoring in the home or residence; this includes a beneficiary’s home that has been made provider-based to the hospital during the covid-19 public health emergency

 

Resources:

Payment Allowances and Effective Dates for COVID-19 Monoclonal Antibodies and Administration During PHE