Originally published February 3, 2021
Updated November 17, 2021
This article details the administration and reimbursement of 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:
- Casirivimab and imdevimab, on November 21, 2020
- Bamlanivimab and etesevimab, on February 9, 2021
- Sotrovimab, on May 26, 2021
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. 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.
Bamlanivimab plus Etesevimab Are Now Authorized for Use in California for COVID-19
As of September 2, 2021, the use and distribution of bamlanivimab plus etesevimab when administered together was resumed in all U.S. states, territories and jurisdictions. Previously, on June 25, 2021, the distribution of bamlanivimab plus etesevimab was paused in the United States due to an increase in the combined frequencies of two SARS-CoV-2 variants of concern (VOC) circulating across the country: Gamma (P.1) and Beta (B.1.351). However, the Delta (B.1617.2, non-AY.1/AY.2) variant has since become the predominant variant circulating in all states in recent months. Since bamlanivimab plus etesevimab together retain activity against the Delta variant, their use and distribution was resumed. For additional details regarding specific variants and resistance, please review the antiviral resistance information in section 15 of each of the fact sheets.
For more information about viral variants in your area to help you make treatment decisions:
- 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.
Revision of EUA for Regeneron Monoclonal Antibody Product Casirivimab and Imdevimab (REGEN-COVTM) to Include Repeat Doses for PEP
As of July 30, 2021, the FDA revised the EUA for casirivimab and imdevimab to allow its use for post-exposure prophylaxis (PEP) in certain adult and pediatric patients. For patients who meet the criteria for repeat dosing, the authorized dosage is an initial dose of 1200 mg, followed by subsequent repeat dosing of 600 mg once every four weeks for the duration of ongoing exposure. Due to this update, the Centers for Medicare & Medicaid Services (CMS) has issued a new product code for casirivimab and imdevimab of 600 mg (Q0240) and two new codes for the administration of repeat doses of casirivimab and imdevimab (M0240 and M0241). Providers administering casirivimab and imdevimab for PEP should use HCPCS code M0243 or M0244 for administering the first dose, and M0240 or M0241 for administering subsequent repeat doses.
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, with the exception of sotrovimab. These reimbursements will be at the Medicare rate approved by 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.
Sotrovimab will not be purchased and supplied for free by the federal government. Providers may purchase this product through typical purchasing channels and submit the product code for reimbursement.
Billing Instructions for the COVID-19 Vaccines
Providers must submit the appropriate vaccine administration codes for billing the first, second and third doses of the Pfizer-BioNTech and Moderna vaccines and the single dose of the Janssen vaccine. The third doses are for certain individuals with compromised immune systems as approved by FDA.
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)
- 0011A (Moderna COVID-19 Vaccine Administration – First Dose)
- 0012A (Moderna COVID-19 Vaccine Administration – Second Dose)
- 0013A (Moderna Covid-19 Vaccine Administration – Third Dose)
- 0031A (Janssen COVID-19 Vaccine Administration) – Single Dose)
- 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 in the Part 2 Medi-Cal 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. They must verify through CAIR2 that the vaccine for the second dose is the same brand that was administered for the first dose.
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 second 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)
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. DHCS will also reimburse for the cost of the provider-purchased sotrovimab when billed with the appropriate code.
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
||Intravenous infusion or subcutaneous injection, casirivimab and imdevimab, includes infusion or injection, and post administration monitoring
||November 21, 2020
||Intravenous infusion or subcutaneous injection, casirivimab and imdevimab, includes infusion or 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
||May 6, 2021
||Intravenous infusion or subcutaneous injection, casirivimab and imdevimab, includes infusion or injection and post administration monitoring, subsequent repeat doses
||July 30, 2021
||Intravenous infusion or subcutaneous injection, casirivimab and imdevimab, includes infusion or 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, subsequent repeat doses
||July 30, 2021
||Intravenous infusion, sotrovimab, includes infusion and post administration monitoring
||May 26, 2021
||vIntravenous infusion, sotrovimab, includes infusion 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
||May 26, 2021
||Q0247 Injection, sotrovimab, 500 mg May 26, 2021
||May 26, 2021
||Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring
||February 9, 2021
||Intravenous infusion, bamlanivimab and etesevimab, includes infusion 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
||May 6, 2021
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 for REGEN-COV or bamlanivimab and etesevimab, as they are not reimbursed by Med-Cal at this time:
- Q0240 (injection, casirivimab and imdevimab, 600 mg)
- Q0243 (injection, casirivimab and imdevimab, 2400 mg)
- Q0244 (injection, casirivimab and imdevimab, 1200 mg)
- Q0245 (injection, bamlanivimab and etesevimab, 2100 mg)