Originally published February 3, 2021
Updated July 14, 2021
This article is regarding the administration and reimbursement of coronavirus 2019 (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.
Revision of Emergency Use Authorization for Regeneron Monoclonal Antibody Product Casirivimab & Imdevimab (REGEN-COVTM)
On June 3, the U.S. Food and Drug Administration (FDA) released a revised Emergency Use Authorization (EAU) for Regeneron’s COVID-19 monoclonal antibody combination product casirivimab and imdevimab. The updated EUA includes a new dosing regimen (1200 mg vs. 2400 mg) and allows a subcutaneous route of administration. In response to this change, CMS created a new HCPCS code (Q0244), effective June 3, and updated the short and long code descriptors for the two administration codes (M0243 and M0244). See code descriptions in the reimbursement section below.
Additional Monoclonal Antibody Sotrovimab authorized for Treatment of COVID-19
On May 26, 2021, FDA, issued a EUA for the investigational monoclonal antibody therapy sotrovimab, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Sotrovimab may only be administered in settings in which healthcare 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.
Bamlanivimab plus Etesevimab No Longer Recommended for Use in California for COVID-19
On May 26, 2021, the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) stopped the distribution of bamlanivimab plus etesevimab to California. This is due to the identification by the Centers for Disease Control and Prevention (CDC) that the combined frequency of the P.1 variant and the B.1.351 variant has now exceeded 10% in California. Susceptibility results from in vitro assays of viral variants to particular monoclonal antibodies indicate that bamlanivimab and etesevimab administered together are not active against either the P.1 or the B.1.351 variants.
Revocation of the Bamlanivimab Emergency Use Authorization
On March 24, 2021, the U.S. Government, in coordination with Eli Lilly and Company, stopped distributing bamlanivimab alone as a result of an increase in COVID-19 viral variants in the U.S. that are resistant to bamlanivimab when administered alone. In addition, on April 16, the FDA revoked the EUA for bamlanivimab monotherapy.
Casirivimab plus Imdevimab (REGEN-COVTM) Now Recommended by FDA for Providers in California
Given the above updates regarding variant resistance to bamlanivimab alone and bamlanivimab plus etesevimab administered together, the U.S. Food and Drug Administration (FDA) recommends that health care providers in California use the monoclonal antibody combination, casirivimab and imdevimab, administered together. Results from in vitro assay data indicate that casirivimab plus imdevimab is likely to retain activity against the P.1 and B.1.351 variants.
For more information about viral variants in your area to help you make treatment decisions:
REGEN-COVTM (casirivimab plus imdevimab) is 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 of progressing to severe COVID-19 and/or hospitalization. These combination therapies 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 Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of REGEN-COV™ (casirivimab and imdevimab) for more information including the limits of authorized use and information about variant resistance. For additional details regarding the specific variants and resistance, please review the Antiviral Resistance information in Section 15 of each of the Fact Sheets.
All treatment sites can continue ordering REGEN-COV™ from the authorized distributer using the direct ordering process. Follow your existing ordering and reporting procedures.
With the exception of Sotrovimab, 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.
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 and second doses of the Pfizer-BioNTech and Moderna vaccines and the single dose of the Janssen vaccine.
- 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)
- 0031A (Janssen COVID-19 Vaccine Administration) – Single 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 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 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 Current Procedural Terminology (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-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)
- 91303 (severe acute respiratory syndrome coronavirus 2 [SARS-CoV2] [coronavirus disease [COVID-19]) vaccine, 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, and are therefore reminded 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 for 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 that supports 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 emergency use authorization fact sheet for patients/caregivers for the applicable product.
- M0243 (Intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring) – effective date 11/21/2020
- M0244 (intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring 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) – effective date 05/06/2021
- M0247 (intravenous infusion, sotrovimab, includes infusion and post administration monitoring) – effective date 5/26/2021
- M0248 (intravenous 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) – effective date 5/26/2021
- Q0247 (injection, sotrovimab, 500 mg) – effective date 5/26/2021
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 whom nursing homes contract to administer treatment
Providers should not use the following HCPCS code when billing for REGEN-COVTM, as they are currently not reimbursed by DHCS:
- Q0243 (injection, casirivimab and imdevimab, 2,400 mg)
- Q0244 (injection, casirivimab and imdevimab, 1200 mg)