SPECIAL BULLETIN COVID-19 #209: HCPCS Code Q0220: Billing Guidelines for Tixagevimab and Cilgavimab, Copackaged as Evusheld Emergency Use of Evusheld approved by FDA

Effective with date of service Dec. 8, 2021, the NC Medicaid and NC Health Choice programs cover tixagevimab injection; cilgavimab injection, copackaged for intramuscular use (Evusheld™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code Q0220 - Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (age 12 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.

Strength/Package Size(s): 

       Injection:

  • Tixagevimab 150 mg/1.5 mL (100 mg/mL) in a single-dose vial
  • Cilgavimab 150 mg/1.5 mL (100 mg/mL) in a single-dose vial

The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product Evusheld (tixagevimab co-packaged with cilgavimab), SARS-CoV-2 spike protein-directed attachment inhibitor, for the pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):

  • Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARSCoV-2 AND
  • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination OR
  • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID19 vaccine component(s)

    Evusheld is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Evusheld under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.

LIMITATIONS OF AUTHORIZED USE:

  • Evusheld is not authorized for use in individuals:

    • For treatment of COVID-19, or
    • For post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2
  • Pre-exposure prophylaxis with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate to severe immune compromise who may derive benefit from COVID-19 vaccination, should receive COVID-19 vaccination.
  • In individuals who have received a COVID-19 vaccine, Evusheld should be administered at least two weeks after vaccination
  • Recommended Dose: 150 mg of tixagevimab and 150 mg of cilgavimab administered as two separate consecutive intramuscular injections

    See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code(s) required for billing is/are:  

    • U07.1 - COVID-19 
    • B34.2 - Coronavirus infection, unspecified
    • Z29.8 - Encounter for other specified prophylactic measures
       
  • Providers must bill with HCPCS code: Q0220 - 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
  • One Medicaid and NC Health Choice unit of coverage is: 300 mg (1 dose of 150 mg of tixagevimab and 150 mg of cilgavimab)
  • The maximum reimbursement rate per unit is: N/A
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDC is: Carton (2 vials per pack): 00310-7442-02
  • Components:
    • 1 vial of tixagevimab 150 mg/1.5 mL (100 mg/mL) (dark grey cap): 00310-8895-01
    • 1 vial of cilgavimab 150 mg/1.5 mL (100 mg/mL) (white cap): 00310-1061-01
  • The NDC units should be reported as "UN1".
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website.
  • The fee schedule for the PADP is available on DHB's PADP web page.

Additional information

  • These MABs will only be administered in settings in accordance with the EUA and in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. Adverse events associated with medications should be reported on the FDA’s MedWatch reporting program.
  • CMS expects that health care providers will maintain appropriate medical documentation that supports the medical necessity of the service. This includes documentation that supports that the terms of the EUAs are met. The documentation should also include the name of the practitioner who ordered or made the decision to administer the infusion.
  • When MAB doses are provided by the government without charge, providers should only bill for the administration.
  • Administration codes to use:
    • M0220 - 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
    • M0221 - 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
    • Rates for administration of the MABs can be found on specific provider fee schedules. 
    • Outpatient hospital claims should be filed with RC 261 and the appropriate HCPCS code

CONTACT

NCTracks Contact Center: 800-688-6696

This blog is related to:

https://medicaid.ncdhhs.gov/blog/2022/01/06/special-bulletin-covid-19-209-hcpcs-code-q0220-billing-guidelines-tixagevimab-and-cilgavimab