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Feb 6, 2023 8:00:00 AM2 min read

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

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

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