COVID-19 Vaccines and Monoclonal Antibodies

Medicare Part B Payment for COVID-19 Vaccines and Certain Monoclonal Antibodies during the Public Health Emergency

CMS has released a set of toolkits for providers, states and insurers to help the health care system prepare and assist in swiftly administering these products once they become available.  These resources are designed to increase the number of providers that can administer the products and ensure adequate reimbursement for administration in Medicare, while making it clear to private insurers and Medicaid programs their responsibility to cover these products at no charge to beneficiaries.  This webpage provides the payment allowances and other related information for these products.  For more information, review the COVID-19 provider toolkit.

Payment Allowances and Effective Dates for COVID-19 Vaccines and their Administration During the Public Health Emergency:(DOS = Date of Service, TBD = To Be Determined)

^[1] Since we anticipate that providers, initially, will not incur a cost for the product, CMS will update the payment allowance at a later date.  Providers should not bill for the product if they received it for free.

^[2] These rates will also be geographically adjusted for many providers. For providers and suppliers with payments that are geographically adjusted by the methodology used by the Medicare Physician Fee Schedule (MPFS), files with the geographically adjusted payment rates for COVID-19 vaccine administration are included in the “Additional Resources” section below. Certain settings utilize other payment methodologies, such as payment based on reasonable costs.

^[3] Johnson & Johnson COVID-19 Vaccine

Payment Allowances and Effective Dates for COVID-19 Monoclonal Antibodies and their Administration During the Public Health Emergency:

^[1] Since we anticipate that providers, initially, will not incur a cost for the product, CMS will update the payment allowance at a later date.  Providers should not bill for the product if they received it for free.

^[3] These rates will be geographically adjusted for many providers.  For providers and suppliers with payments that are geographically adjusted by the methodology used by the Medicare Physician Fee Schedule (MPFS), files with the geographically adjusted payment rates for monoclonal antibody administration are included in the “Additional Resources” section below. Certain settings utilize other payment methodologies, such as payment based on reasonable costs.

^[4]On April 16, 2021, the FDA revoked the EUA that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Due to this revocation, Medicare will not pay for claims with HCPCS codes M0239 or Q0239 with dates of service after 4/16/2021.

^[5]On June 3, 2021, the FDA issued an updated EUA for casirivimab and imdevimab that changed the allowed dosing regime from 2400 mg to 1200 mg, and allowed for the administration of the combination product via subcutaneous injection in limited circumstances. Due to these changes, CMS has issued a new product code for casirivimab and imdevimab (Q0244), and updated the descriptors for the existing administration codes (M0243/M0244). 

^[6] On 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 4 weeks for the duration of ongoing exposure. Due to this update, CMS has issued a new product code for casirivimab and imdevimab of 600 mg (Q0240), and 2 new codes for the administration of repeat doses of casirivimab and imdevimab (M0240/M0241). Providers and suppliers administering casirivimab and imdevimab for PEP should use M0243 or M0244 for administering the first dose, and M0240 or M0241 for administering subsequent repeat doses.

^[7] When the government provides monoclonal antibody products to treat COVID-19 for free, providers should only bill for the administration; don’t include the monoclonal antibody product codes on these claims. If you got the product for free, and your systems require a product code to bill for the administration, enter $0.01 for the billed amount.

^[8] On September 16, 2021, the FDA revised the EUA for bamlanivimab and etesevimab, administered together, to allow its use for post-exposure prophylaxis (PEP) in certain adult and pediatric patients. Providers and suppliers should use Q0245 and M0245 or M0246 to bill for administering bamlanivimab and etesevimab for PEP.

Additional Resources:

Following links contain helpful information for providers. Product NDCs can be found in the EUA Fact Sheet for Healthcare Providers and can be used to identify the appropriate HCPCS codes for each product and its administration.  NDC - HCPCS crosswalk is available in CMS ASP crosswalk zip folder. Long, medium, and short descriptors of COVID-19 CPT codes are available from AMA website.

Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction

COVID-19 NDC-HCPCS crosswalk

COVID-19 Vaccination Resources at CDC

COVID-19 CPT vaccine and immunization codes - AMA

Quick reference guide to the coding structure for COVID-19 vaccine CPT reporting

Bamlanivimab Emergency Use Authorization

Casirivimab and imdevimab Emergency Use Authorization (ZIP)

Bamlanivimab and etesevimab Emergency Use Authorization

Sotrovimab Emergency Use Authorization

Tocilizumab Emergency Use Authorization

Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization (PDF)

Moderna COVID-19 Vaccine Emergency Use Authorization (PDF)

Janssen COVID-19 Vaccine Emergency Use Authorization

Fact Sheet for Healthcare Providers - Emergency Use Authorization of bamlanivimab

Fact Sheet for Healthcare Providers - Emergency Use Authorization of casirivimab and imdevimab

Fact Sheet for Healthcare Providers - Emergency Use Authorization of bamlanivimab and etesevimab

Fact Sheet for Healthcare Providers - Emergency Use Authorization of sotrovimab

Fact Sheet for Healthcare Providers – Emergency Use Authorization of tocilizumab (ZIP)

Fact Sheet for Healthcare Providers - Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine

Fact Sheet for Healthcare Providers - Emergency Use Authorization of Moderna COVID-19 Vaccine

Fact Sheet for Healthcare Providers - Emergency Use Authorization of Janssen COVID-19 Vaccine

Information about Public Health Emergency

COVID-19 Vaccination Training Programs and Reference Materials for Healthcare Professionals

2020 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP) 

2020 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP)

Jan-May 2021 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP) [For claims with dates of service of 1/1/2021 through 5/5/2021]

May-Dec 2021 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP) *Updated 7/30/2021 to account for new codes for casirivimab and imdevimab* [For claims with dates of service 5/6/2021 through 12/31/2021]

Jan - March 2021 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP) *Updated February 16, 2021 for addition of the COVID-19 Janssen vaccine* [For claims with dates of service of 1/1/2021 through 3/14/2021]

March - Dec 2021 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP) *Updated 11/02/2021 to account for effective dates for Pfizer-BioNTech COVID-19 Pediatric Vaccine [For claims with dates of service 3/15/2021 through 12/31/2021]