Reimbursement of COVID-19 Vaccine and Monoclonal Antibody Administration for Medical Providers

Originally published February 3, 2021
Updated April 22, 2022

This article details the administration and reimbursement of coronavirus disease 2019 (COVID-19) vaccines and monoclonal antibodies when administered as Physician Administer Drugs (PADs) by medical providers. This is one in a series of articles containing instructions from the Department of Health Care Services (DHCS) for billing and reimbursement as they pertain to COVID-19 therapeutics.

The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the following investigational monoclonal antibody therapies:

  • Tixagevimab and cilgavimab (Evusheld), on December 8, 2021

  • Bebtelovimab, on February 11, 2022

Except for Evusheld, these products are for the treatment of mild-to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive COVID-19 test results who are at high risk for progressing to severe COVID-19, including hospitalization or death. Evusheld is for the pre-exposure prophylaxis of COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg).

These products may only be administered in settings 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.

Please review the following for more information regarding the limits of authorized use, including information about viral variants and antiviral resistance:

All treatment sites can continue to order these monoclonal antibodies from the authorized distributor using the direct ordering process. Follow your existing ordering and reporting procedures.

Providers can find public locations that have received shipments via COVID-19 Therapeutics Locator, ArcGIS.

For California, see Distribution and Ordering of Anti-SARS-CoV-2 Therapeutics on California Department of Public Health (CDPH) website.

Important Updates

Sotrovimab Monoclonal Antibody No Longer Authorized to Treat COVID-19

On April 5, 2022, the FDA announced that Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 Sub-Variant.

Data from the Centers for Disease Control and Prevention’s (CDC) COVID Tracker estimated that the proportion of COVID-19 cases caused by the Omicron BA.2 variant was above fifty percent in all Health and Human Services (HHS) U.S. regions. Based on data from the health care provider fact sheet, the authorized dose of Sotrovimab is unlikely to be effective against the BA.2 sub-variant. Given this, Sotrovimab is not authorized in any U.S. state or territory at this time.

Providers must not submit claims for the administration of Sotrovimab for dates of service on or after April 5, 2022, as they will be denied.

Providers should note that there are several other therapies that are expected to work against the Omicron variant, which are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Medi-Cal covers these therapies which are listed below:

  • Bebtelovimab

  • Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use)

  • Veklury (Remdesivir)

  • Lagevrio (molnupiravir)

  • Evusheld (tixagevimab co-packaged with cilgavimab)

    • Refer to Variant Proportions in the U.S. on the Centers for Disease Control and Prevention (CDC) website for general information.

    • Refer to Tracking Variants on the California Department of Public Health (CDPH) website for California-specific information.

New Monoclonal Antibody Product: Bebtelovimab

On February 11, 2022, the FDA authorized the EUA of the monoclonal antibody bebtelovimab, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

Reimbursements

Because the vaccines and monoclonal antibodies are currently supplied free to providers by the federal government, DHCS will only reimburse the administration fees for the vaccines and monoclonal antibodies below. These reimbursements will be at the Medicare rate approved by the Centers for Medicare & Medicaid Services (CMS). DHCS will provide future guidance regarding the billing and reimbursement of provider-purchased products at the appropriate time. Providers must bill for administration of the COVID-19 vaccines and monoclonal antibodies using the appropriate administration codes for reimbursement.

Billing Instructions for the COVID-19 Vaccines

Providers must submit the appropriate vaccine administration codes for billing the first, second, third and booster doses of the Pfizer-BioNTech and Moderna vaccines and the single and booster doses of the Janssen vaccine.

Reimbursable COVID-19 Vaccine Codes

  • 0001A (Pfizer-BioNtech COVID-19 Vaccine Administration – First Dose)
  • 0002A (Pfizer-BioNtech COVID-19 Vaccine Administration – Second Dose)
  • 0003A (Pfizer-BioNtech COVID-19 Vaccine Administration – Third Dose)
  • 0004A (Pfizer-BioNTech COVID-19 Vaccine Administration – Booster)
  • 0051A (Pfizer-BioNTech Covid-19 Vaccine (Ready to Use) Administration – First Dose)
  • 0052A (Pfizer-BioNTech Covid-19 Vaccine (Ready to Use) Administration – Second Dose)
  • 0053A (Pfizer-BioNTech Covid-19 Vaccine (Ready to Use) Administration – Third Dose)
  • 0054A (Pfizer-BioNTech Covid-19 Vaccine (Ready to Use) Administration – Booster)
  • 0071A (Pfizer-BioNTech COVID-19 Pediatric Vaccine – Administration – First Dose)
  • 0072A (Pfizer-BioNTech COVID-19 Pediatric Vaccine – Administration – Second Dose)
  • 0073A (Pfizer-BioNTech COVID-19 Pediatric Vaccine - Administration – Third Dose)
  • 0011A (Moderna COVID-19 Vaccine Administration – First Dose)
  • 0012A (Moderna COVID-19 Vaccine Administration – Second Dose)
  • 0013A (Moderna COVID-19 Vaccine Administration – Third Dose)
  • 0064A (Moderna COVID-19 Vaccine (Low Dose) Administration – Booster)
  • 0031A (Janssen COVID-19 Vaccine Administration – Single Dose)
  • 0034A (Janssen COVID-19 Vaccine Administration – Booster)
  • M0201 (COVID-19 vaccine administration inside a patient's home; reported only once per individual home per date of service when only COVID-19 vaccine administration is performed at the patient's home)

For additional details regarding the policies and eligible patients for the administration of the third and booster doses and the Home Administration of the COVID-19 vaccine, refer to the Immunizations section of Part 2-General Medicine (GM) in the Provider Manual.

Providers must administer the vaccine in accordance with the CDC and Advisory Committee on Immunization Practices (ACIP) requirements.

Providers must meet the storage and recordkeeping requirements, including recording the administration of the vaccine to patients in their own systems within 24 hours and to the California Immunization Registry (CAIR2) within 24 hours.

It is important to provide vaccine recipients with the EUA fact sheet for patients/caregivers and vaccination cards identifying the brand of vaccine administered and the date of their next vaccination (if applicable).

Non-Reimbursable COVID-19 Vaccine Codes

Providers should not use the following CPT® codes when billing for these vaccines, as they are not reimbursed by Medi-Cal at this time:

  • 91300 (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] [Coronavirus disease (COVID-19)] vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use)

  • 91301 (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] [Coronavirus disease (COVID-19)] vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use)

  • 91303 (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] [Coronavirus disease (COVID-19)], DNA, spike protein, adenovirus type 26 (Ad26) vector, preservative free, 5x1010 viral particles/0.5mL dosage, for intramuscular use)

  • 91306 (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] [coronavirus disease (COVID-19)] vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.25 mL dosage, for intramuscular use)

  • 91307 (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] [coronavirus disease (COVID-19)] vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use)

If providers bill using these CPT codes, they may receive a Remittance Advice Details (RAD) code of 0145: This procedure is not a Medi-Cal benefit on this date of service, reminding them that the administration of the vaccine is reimbursable at this time, and not the vaccine itself.

Billing Instructions for the Monoclonal Antibodies

DHCS will reimburse the cost of administration (infusion) when billed with the administration codes listed below as appropriate when administered in accordance with FDA EUAs. Specific billing instructions are located in the Immunizations manual section of the appropriate Part 2 manual.

In accordance with CMS guidelines, providers must maintain appropriate medical documentation that supports the medical necessity of the service, including documentation supporting that the terms of the EUAs are met. The documentation should also include the name of the provider who ordered or made the decision to administer the infusion.

It is important to provide monoclonal antibody recipients the EUA fact sheet for patients/caregivers for the applicable product.

Reimbursable COVID-19 Monoclonal Antibody Codes
HCPCS Codes HCPCS Descriptions Effective Dates
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 December 8, 2021

(Providers are to hold all billing claims until April 1, 2022 when DHCS claims system can process them).
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 December 8, 2021

(Providers are to hold all billing claims until April 1, 2022 when DHCS claims system can process them).
M0222 Intravenous injection, bebtelovimab, includes injection and post administration monitoring February 11, 2022

(Providers are to hold all billing claims until June 1, 2022 when DHCS claims system can process them).
M0223 Intravenous injection, bebtelovimab, includes injection and post administration monitoring in the home or residence; this includes a beneficiary‚Äôs home that has been made provider-based to the hospital during the COVID-19 public health emergency February 11, 2022

(Providers are to hold all billing claims until June 1, 2022 when DHCS claims system can process them).

DHCS allows a broad range of providers and suppliers to administer these treatments, including but not limited to:

  • Freestanding and hospital-based infusion centers

  • Home health agencies

  • Nursing homes

  • Entities with which nursing homes contract to administer treatment

Non-Reimbursable Monoclonal Antibody Codes

Providers should not use the following HCPCS codes when billing Bebtelovimab or Evusheld as they are not reimbursed by Med-Cal at this time:

  • 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)

  • Q0222 (injection, bebtelovimab, 175 mg)