This article is regarding the administration and reimbursement of COVID-19 vaccines and monoclonal antibodies when administered by medical providers as a Physician Administered Drug (PAD). This is one in a series of articles containing the Department of Health Care Services’ (DHCS) instructions 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 two investigational monoclonal antibody therapies. The first was bamlanivimab on November 9, 2020, followed by casirivimab and imdevimab on November 21, 2020. Both 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 and/or hospitalization. Both 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. Review the Fact Sheet for Healthcare Providers for bamlanivimab EUA and the Health Care Provider Fact Sheet for casirivimab and imdevimab EUA regarding the limitations of authorized use and mandatory requirements.
DHCS will reimburse for the administration (infusion) of these monoclonal antibodies when administered in accordance with the respective EUAs.
Since the vaccines and monoclonal antibodies are currently supplied by the federal government free to providers, DHCS will only reimburse the administration fees for both the vaccines and monoclonal antibodies. These reimbursements will be at the Medicare rate approved by 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 and second doses of the Pfizer-BioNTech and Moderna vaccines as applicable.
- 0001A ( Pfizer-Biontech COVID-19 Vaccine Administration – First Dose)
- 0002A (Pfizer-Biontech COVID-19 Vaccine Administration – Second Dose)
- 0011A (Moderna COVID-19 Vaccine Administration – First Dose)
- 0012A (Moderna COVID-19 Vaccine Administration – Second Dose)
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 72 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 emergency use authorization fact sheet for patients/caregivers and vaccination cards identifying the brand of vaccine administered and the date of their second vaccination (if applicable).
Providers should not use the following CPT® codes when billing for these vaccines, as they are currently not reimbursed by DHCS:
- 91300 (severe acute respiratory syndrome coronavirus 2 (SARSs-CoV2) (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)
Billing Instructions for the Monoclonal Antibodies
DHCS will reimburse for the cost of administration (infusion) when billed with the following administration codes as appropriate when administered in accordance with FDA EUAs.:
- M0239 (Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring) – effective date 11/9/2020
- M0243 (Intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring) – effective date 11/21/2020
Providers should not use the following HCPCS codes when billing for these monoclonal antibodies, as they are currently not reimbursed by DHCS:
- Q0239 (injection, bamlanivimab-xxxx, 700 mg)
- Q0243 (injection, casirivimab and imdevimab, 2,400 mg)