COVID-19 Monoclonal Antibodies

Review the Antiviral Resistance information in the Fact Sheet for each monoclonal antibody therapy authorized under an emergency use authorization (EUA) for details regarding specific variants and resistance. You should also refer to the CDC and information from state and local health authorities regarding reports of viral variants of importance in your region to guide treatment decisions.

COVID-19 VEKLURY® (Remdesivir) in the Outpatient Setting

On April 25, 2022, the FDA approved a supplemental New Drug Application (NDA) for VEKLURY, which expanded its approval for use in the outpatient setting. See the FDA letter for more information about the NDA approval and revoked EUA.

The federal government isn’t purchasing VEKLURY. Medicare Part B pays for the drug and its administration under the applicable Medicare Part B payment policy when you provide it in the outpatient setting, according to the FDA approval. In most cases, your patient’s yearly Part B deductible and 20% coinsurance apply.

CMS created HCPCS code J0248 for VEKLURY, effective December 23, 2021. J0248 represents 1mg, and you should report units to reflect the dosage you administered for each patient.

For more information about billing and payment for VEKLURY in the outpatient setting:

• Visit the Medicare Part B Drug Average Sales Price webpage
• See the COVID-19 FAQs (PDF) 

COVID-19 Monoclonal Antibody Products

Monoclonal Antibodies for Pre-Exposure Prophylaxis of COVID-19

The FDA authorized the following investigational monoclonal antibody products under EUA for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents:

• EVUSHELD^TM (tixagevimab co-packaged with cilgavimab) (EUA issued December 8, 2021, latest update January 26, 2023). On January 26, 2023, the FDA announced that EVUSHELD isn’t currently authorized for emergency use in the U.S.  
• PEMGARDA (pemivibart) (EUA issued March 22, 2024, latest update August 26, 2024). 

Monoclonal Antibodies to Treat Mild-to-Moderate COVID-19

The FDA approved or authorized under EUA the following additional investigational monoclonal antibody therapies:

• ACTEMRA® (tocilizumab) (EUA issued June, 24 2021, latest update December 21, 2022). On December 23, 2022, the FDA announced approval of a new indication for ACTEMRA (effective December 21, 2022) to treat hospitalized adult patients with severe COVID-19 illness. ACTEMRA remains authorized under EUA to treat hospitalized pediatric patients (ages 2-17 years) with severe COVID-19 illness. See the EUA for more information.
• Bamlanivimab (EUA issued November 9, 2020, EUA revoked April 16, 2021). On April 16, 2021, the FDA revoked the EUA for bamlanivimab, when administered alone.
• Bamlanivimab and etesevimab, administered together (EUA issued February 9, 2021, EUA revoked December 14, 2023). On December 14, 2023, the FDA revoked the EUA for bamlanivimab and etesevimab, administered together. 
• Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). On November 30, 2022, the FDA announced that bebtelovimab isn’t currently authorized in any U.S. region.
• REGEN-COV® (casirivimab and imdevimab, administered together) (EUA issued November 21, 2020, latest update January 24, 2022). On January 24, 2022, the FDA announced that REGEN-COV isn't currently authorized in any U.S. region. 
• Sotrovimab (EUA issued May 26, 2021, latest update February 23, 2022). On April 5, 2022, the FDA announced that sotrovimab isn't currently authorized in any U.S. region. 

The FDA authorized the use of these monoclonal antibody therapies to treat mild-to-moderate COVID-19 in adults and pediatric patients when they:

• Have a positive COVID-19 test result
• Are at high risk for progressing to severe COVID-19, hospitalization, or both

Health care providers may administer these monoclonal antibody therapies only in settings where they have both:

• Immediate access to medications to treat a severe infusion reaction, such as anaphylaxis
• The ability to activate the emergency medical system (EMS)

More Information about COVID-19 Monoclonal Antibody Products

For more information about the limits of authorized use for these monoclonal antibody therapies, including information about viral variants and antiviral resistance, review these EUA fact sheets for health care providers:

• ACTEMRA (tocilizumab) 
• Bebtelovimab
• EVUSHELD (tixagevimab co-packaged with cilgavimab)
• PEMGARDA (pemivibart)
• REGEN-COV (casirivimab and imdevimab)
• Sotrovimab

Viral Variants & Monoclonal Antibody Resistance

The virus that causes COVID-19 (SARS-CoV-2) is constantly changing, and CDC expects new viral variants to continue to emerge. For details about specific variants and monoclonal antibody resistance, review the antiviral resistance information in each of the Fact Sheets listed above.

Learn about viral variants in your area to help you make treatment decisions:

• Review the CDC information on Variant Proportions
• Refer to information from your state and local health authorities

Medicare & COVID-19 Monoclonal Antibody Products

You can purchase currently authorized monoclonal antibody products through typical purchasing channels.

Coverage

Medicare Coverage for COVID-19 Monoclonal Antibody Products

Medicare will cover and pay for the administration of monoclonal antibody infusions and injections used for post-exposure prophylaxis or treatment of COVID-19 (when furnished consistent with their approvals or EUAs) under the Part B preventive vaccine benefit until the end of the calendar year in which the EUA declaration for COVID-19 drugs and biologicals ends. The EUA declaration is distinct from, and not dependent on, the PHE for COVID-19. Learn more about what happens to EUAs when a PHE ends.

Note:
Medicare will only cover and pay for:  Bamlanivimab (administered alone) if it was furnished, consistent with the terms of the EUA, between November 10, 2020 – April 16, 2021 Bamlanivimab and etesevimab (administered together) if furnished, consistent with the terms of the EUA, between February 9, 2021 – December 14, 2023

Our approach to paying for these products under the Part B preventive vaccine benefit through the end of the calendar year in which the EUA declaration for COVID-19 drugs and biologicals ends allows a broad range of providers to administer these products, including but not limited to:

• Freestanding and hospital-based infusion centers
• Home health agencies
• Nursing homes
• Entities with whom nursing homes contract to administer products

Note:
To help skilled nursing facilities (SNFs) efficiently administer COVID-19 vaccines (including COVID-19 monoclonal antibody products) to residents, CMS exercised enforcement discretion to allow Medicare-enrolled immunizers to bill directly and get Medicare reimbursement for administering vaccines to Medicare SNF residents. This enforcement discretion ended on June 30, 2023.

Effective January 1 of the year after that in which the EUA declaration ends:

• CMS will pay you for monoclonal antibody products used for post-exposure prophylaxis or treatment of COVID-19 the same way we pay for biological products under Section 1847A of the Social Security Act. That is, through the applicable payment system and using the appropriate coding and payment rates, similar to the way we pay for administering other complex biological products.
• CMS will continue to pay for covered monoclonal antibody products and their administration when used as pre-exposure prophylaxis for prevention of COVID-19 under the Part B preventive vaccine benefit.

Coding

Coding for the Administration of COVID-19 Monoclonal Antibody Products

Get codes for COVID-19 monoclonal antibody products and administration for Medicare payment:

Product	EUA Effective & Revocation Date(s)	Product Code	Administration Code
Eli Lilly and Company’s Antibody Bamlanivimab (LY-CoV555)	November 10, 2020 - April 16, 2021 Note: On April 16, 2021, the FDA revoked the EUA for bamlanivimab when administered alone	Q0239 Long descriptor: Injection, bamlanivimab-xxxx, 700 mg Short descriptor: Bamlanivimab-xxxx	M0239 Long descriptor: Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring Short descriptor: Bamlanivimab-xxxx infusion
Regeneron’s Antibody REGEN-COV (casirivimab and imdevimab) (ZIP) Note: This product isn’t currently authorized[1]	November 21, 2020 - TBD Note: While the product EUA was originally issued on November 21, 2020, these product and administration codes are effective July 30, 2021	Q0240[2] Long descriptor: Injection, casirivimab and imdevimab, 600 mg Short descriptor: Casirivi and imdevi 600 mg	M0240[2] Long descriptor: Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring, subsequent repeat doses Short descriptor: Casirivi and imdevi repeat
Regeneron’s Antibody REGEN-COV (casirivimab and imdevimab) (ZIP)   Note: This product isn’t currently authorized[1]	November 21, 2020 - TBD Note: While the product EUA was originally issued on November 21, 2020, these product and administration codes are effective July 30, 2021	Q0240[2] Long descriptor: Injection, casirivimab and imdevimab, 600 mg Short descriptor: Casirivi and imdevi 600 mg	M0241[2] Long descriptor: 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 Short descriptor: Casirivi and imdevi repeat hm
Regeneron’s Antibody REGEN-COV (casirivimab and imdevimab) (ZIP) Note: This product isn’t currently authorized[1]	November 21, 2020 - TBD	Q0243 Long descriptor: Injection, casirivimab and imdevimab, 2400 mg Short descriptor: Casirivimab and imdevimab Q0244[3] Long descriptor: Injection, casirivimab and imdevimab, 1200 mg Short descriptor: Casirivi and imdevi 1200 mg	M0243 Long descriptor: Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring Short descriptor: Casirivi and imdevi inj
Regeneron’s Antibody REGEN-COV (casirivimab and imdevimab) (ZIP) Note: This product isn’t currently authorized[1]	November 21, 2020 – TBD Note: While the product EUA was issued on November 21, 2020, this administration code is effective May 6, 2021	Q0243 Long descriptor: Injection, casirivimab and imdevimab, 2400 mg Short descriptor: Casirivimab and imdevimab Q0244[3] Long descriptor: Injection, casirivimab and imdevimab, 1200 mg Short descriptor: Casirivi and imdevi 1200 mg	M0244 Long descriptor: 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 Short descriptor: Casirivi and imdevi inj hm
Eli Lilly and Company’s Antibody Bamlanivimab and Etesevimab (ZIP)	February 9, 2021 – December 14, 2023 Note: On December 14, 2023, the FDA revoked the EUA for bamlanivimab and etesevimab, administered together	Q0245[4] Long descriptor: Injection, bamlanivimab and etesevimab, 2100 mg Short descriptor: Bamlanivimab and etesevima	M0245[4] Long descriptor: Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring Short descriptor: Bamlan and etesev infusion
Eli Lilly and Company’s Antibody Bamlanivimab and Etesevimab, (ZIP)	February 9, 2021  – December 14, 2023 Note: While the product EUA was issued on February 9, 2021, this administration code is effective May 6, 2021   Note: On December 14, 2023, the FDA revoked the EUA for bamlanivimab and etesevimab, administered together	Q0245[4] Long descriptor: Injection, bamlanivimab and etesevimab, 2100 mg Short descriptor: Bamlanivimab and etesevima	M0246[4] Long descriptor: 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 Short descriptor: Bamlan and etesev infus home
GlaxoSmithKline’s Antibody Sotrovimab Note: This product isn’t currently authorized[6]	May 26, 2021 - TBD	Q0247 Long descriptor: Injection, sotrovimab, 500 mg Short descriptor: Sotrovimab	M0247 Long descriptor: Intravenous infusion, sotrovimab, includes infusion and post administration monitoring Short descriptor: Sotrovimab infusion
GlaxoSmithKline’s Antibody Sotrovimab Note: This product isn’t currently authorized[6]	May 26, 2021 - TBD	Q0247 Long descriptor: Injection, sotrovimab, 500 mg Short descriptor: Sotrovimab	M0248 Long descriptor: 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 Short descriptor: Sotrovimab inf, home admin
Genentech’s Antibody ACTEMRA (tocilizumab)	June 24, 2021 – TBD	Q0249[5] Long descriptor: Injection, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, 1 mg Short descriptor: Tocilizumab for COVID-19	M0249 Long descriptor: Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, includes infusion and post administration monitoring, first dose Short descriptor: Adm Tocilizu COVID-19 1st
Genentech’s Antibody ACTEMRA (tocilizumab)	June 24, 2021 – TBD	Q0249[5] Long descriptor: Injection, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, 1 mg Short descriptor: Tocilizumab for COVID-19	M0250 Long descriptor: Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, includes infusion and post administration monitoring, second dose Short descriptor: Adm Tocilizu COVID-19 2nd
AstraZeneca’s Antibody EVUSHELD (tixagevimab and Cilgavimab) Note: This product isn’t currently authorized[8]	December 8, 2021 – TBD	Q0220 Long descriptor: 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 Short descriptor: Tixagev and cilgav inj	M0220 Long descriptor: 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 Short descriptor: Tixagev and cilgav inj
AstraZeneca’s Antibody EVUSHELD (tixagevimab and Cilgavimab) Note: This product isn’t currently authorized[8]	December 8, 2021 – TBD	Q0220 Long descriptor: 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 Short descriptor: Tixagev and cilgav inj	M0221 Long descriptor: 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 Short descriptor: Tixagev and cilgav inj hm
AstraZeneca’s Antibody EVUSHELD (tixagevimab and Cilgavimab) Note: This product isn’t currently authorized[8]	February 24, 2022 - TBD	Q0221 Long descriptor: 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), 600 mg Short descriptor: Tixagev and cilgav, 600mg	M0220 Long descriptor: 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 Short descriptor: Tixagev and cilgav inj
AstraZeneca’s Antibody EVUSHELD (tixagevimab and Cilgavimab) Note: This product isn’t currently authorized[8]	February 24, 2022 - TBD	Q0221 Long descriptor: 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), 600 mg Short descriptor: Tixagev and cilgav, 600mg	M0221 Long descriptor: 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 Short descriptor: Tixagev and cilgav inj hm
Eli Lilly and Company’s Antibody Bebtelovimab (PDF) Note: This product isn’t currently authorized[7]	February 11, 2022 - TBD	Q0222 Long descriptor: Injection, bebtelovimab, 175 mg Short descriptor: Bebtelovimab 175 mg	M0222 Long descriptor: Intravenous injection, bebtelovimab, includes injection and post administration monitoring Short descriptor: Bebtelovimab injection
Eli Lilly and Company’s Antibody Bebtelovimab (PDF) Note: This product isn’t currently authorized[7]	February 11, 2022 - TBD	Q0222 Long descriptor: Injection, bebtelovimab, 175 mg Short descriptor: Bebtelovimab 175 mg	M0223 Long descriptor: Intravenous injection, bebtelovimab, 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   Short descriptor: Bebtelovimab injection home
Invivyd’s Antibody PEMGARDA (pemivibart)	March 22, 2024 – TBD	Q0224 Long descriptor: Injection, pemivibart, for the pre-exposure prophylaxis only, for certain adults and adolescents (12 years of age and older weighing at least 40 kg) with no known SARS-CoV-2 exposure, and who either have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, and are unlikely to mount an adequate immune response to COVID-19 vaccination, 4500 mg Short descriptor: Inj, pemivibart, 4500 mg	M0224 Long descriptor: Intravenous infusion, pemivibart, for the pre-exposure prophylaxis only, for certain adults and adolescents (12 years of age and older weighing at least 40 kg) with no known SARS-CoV-2 exposure, who either have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, includes infusion and post administration monitoring Short descriptor:  Pemivibart infusion

 ^[1] On January 24, 2022, the FDA announced that, due to the high frequency of the Omicron variant, REGEN-COV (casirivimab and imdevimab, administered together) isn’t currently authorized in any U.S region. Therefore, you may not administer REGEN-COV for treatment or post-exposure prevention of COVID-19 under the EUA until further notice.

^[2] On July 30, 2021, the FDA revised the EUA for REGEN-COV (casirivimab and imdevimab, administered together) 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. As a result, CMS issued a new product code for REGEN-COV of 600 mg (Q0240) and 2 new codes for the administration of repeat doses of REGEN-COV (M0240/M0241). Providers and suppliers who administer REGEN-COV for PEP should use M0243 or M0244 for administering the first dose and M0240 or M0241 for administering subsequent repeat doses.

^[3] On June 3, 2021, the FDA revised the EUA for REGEN-COV (casirivimab and imdevimab, administered together) to change the allowed dosing regimen from 2400 mg to 1200 mg and allow providers to administer the combination product by subcutaneous injection in limited circumstances. As a result, CMS issued a new product code for REGEN-COV (Q0244) and updated the descriptors for the existing administration codes (M0243/M0244).

^[4] 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.

^[5] Given the limited clinical situations allowed under the FDA approval and EUA, you should only bill for ACTEMRA (tocilizumab) on a 12x type of bill (TOB).

^[6] On April 5, 2022, the FDA announced that, due to the high frequency of the Omicron BA.2 sub-variant, sotrovimab isn’t currently authorized in any U.S. region. Therefore, you may not administer sotrovimab to treat COVID-19 under the EUA until further notice.

^[7] On November 30, 2022, the FDA announced that bebtelovimab isn’t currently authorized in any U.S. region because it isn’t expected to neutralize Omicron sub-variants BQ.1 and BQ.1.1. Therefore, you may not administer bebtelovimab to treat COVID-19 under the EUA until further notice.

^[8] On January 26, 2023, the FDA announced that EVUSHELD isn’t currently authorized for emergency use in the U.S. 

Get the most current list of billing codes, payment allowances, and effective dates.

Payment

Medicare Payment for Administering COVID-19 Monoclonal Antibody Products

To ensure immediate access during the COVID-19 PHE, Medicare covers and pays for these infusions and injections in accordance with Section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). 

CMS will continue to pay for COVID-19 monoclonal antibodies for post-exposure prophylaxis or treatment of COVID-19 under the Part B preventive vaccine benefit through the end of the calendar year in which the EUA declaration for COVID-19 drugs and biologicals ends. The EUA declaration is distinct from, and not dependent on, the PHE for COVID-19. Learn more about what happens to EUAs when a PHE ends. During this interim time, we’ll maintain the administration payment amounts when you infuse or inject these products in health care settings and in the home.

Effective January 1 of the year after that in which the EUA declaration ends:

• CMS will pay you for monoclonal antibody products used for post-exposure prophylaxis or treatment of COVID-19 the same way we pay for biological products under Section 1847A of the Social Security Act. That is, through the applicable payment system and using the appropriate coding and payment rates, similar to the way we pay for administering other complex biological products.
• CMS will continue to pay for covered monoclonal antibody products and their administration when used as pre-exposure prophylaxis for prevention of COVID-19 under the Part B preventive vaccine benefit.

Payment Rates for Infusion

Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering FDA-authorized or -approved COVID-19 monoclonal antibody products through infusion is approximately $450.

• This rate applies to all providers not paid reasonable cost for furnishing these products 
• The new rate reflects updated information about the costs involved in administering monoclonal antibody products for different types of providers and the resources necessary to ensure providers administer the products safely and appropriately 
• We geographically adjust the rate based on where you furnish the service

Note:

Under the terms of the FDA approval and EUA, health care providers can only administer ACTEMRA (tocilizumab) to hospitalized patients in limited clinical situations. The Medicare payment rate of approximately $450 for the administration of COVID-19 monoclonal antibody products applies for the administration of ACTEMRA when you furnish it in accordance with the FDA approval or EUA. The FDA approval and EUA for ACTEMRA also allows for 2 infusions for the same patient in limited situations. Medicare will pay approximately $450 per infusion when 2 infusions are clinically necessary. As with payments for administering other COVID-19 monoclonal antibodies, the separate Medicare payment amount of $450 per infusion of ACTEMRA applies to all hospitals not paid reasonable cost for furnishing these products consistent with the FDA approval or EUA. CMS geographically adjusts the rate based on where you furnish the service. Get the most current geographically adjusted rates.

 

Note:

The July 30, 2021, revised EUA for REGEN-COV (casirivimab and imdevimab, administered together) allows for its use for post-exposure prophylaxis (PEP) for certain patients who have been exposed to (or are at high risk of exposure to) a person with COVID-19. In these situations, use the following HCPCS codes to bill for REGEN-COV: M0243 or M0244 when billing for the administration of the initial dose in a health care setting or the home M0240 or M0241 when billing for the administration of any subsequent repeat doses in a health care setting or the home The September 16, 2021, revised EUA for bamlanivimab and etesevimab allowed for its use for PEP in certain adult and pediatric patients. The FDA revoked the EUA for bamlanivimab and etesevimab on December 14, 2023. For dates of services before December 14, 2023, use the same codes to bill for administering bamlanivimab and etesevimab for PEP and treatment:  M0245 when billing to administer in a health care setting  M0246 when billing to administer in the home or residence

Payment Rates for Intravenous Injections

Effective February 11, 2022, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products by intravenous (IV) injection. Effective for IV injection services furnished on or after February 11, 2022 (such as the administration of bebtelovimab), the Medicare payment rate for administering these FDA-authorized or -approved COVID-19 monoclonal antibody products is approximately $350.50.

• This rate applies to all providers not paid reasonable cost for furnishing these products 
• The new rate reflects updated information about the costs involved in administering these types of monoclonal antibody products for different types of providers and the resources necessary to ensure providers administer the products safely and appropriately 
• We geographically adjust the rate based on where you furnish the service

Get the most current list of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products.

More Information about Payment for Infusion & IV Injection

Medicare also pays for treatment to address major complications:

• As needed and appropriate
• Consistent with existing payment methodologies for the care setting where you provide the treatment

For COVID-19 monoclonal antibody products administered before May 6, 2021, the Medicare payment rate is approximately $310.

Medicare will establish codes and rates for administering new products as the FDA approves or authorizes each product.

Get the most current list of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products.

Payment Rates for Infusion at Home

Beginning on May 6, 2021, Medicare established separate coding and payment for administering COVID-19 monoclonal antibody products through infusion in a patient’s home or residence. Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through infusion in a patient’s home or residence is approximately $750.

• This rate reflects updated information about the costs involved in furnishing these complex products in a patient’s home 
• For many providers, we also geographically adjust this rate based on where you furnish the service 

Payment Rates for IV Injection at Home

Effective February 11, 2022, Medicare established separate coding and payment for administering COVID-19 monoclonal antibody products through IV injection in a patient’s home or residence. Effective for services furnished on or after February 11, 2022, the Medicare payment rate for administering COVID-19 monoclonal antibody products through IV injection (such as bebtelovimab) in a patient’s home or residence is approximately $550.50.

• This rate reflects updated information about the costs involved in furnishing these complex products in a patient’s home 
• For many providers, we also geographically adjust this rate based on where you furnish the service 

More Information about Payment for Infusion & IV Injection at Home

Note:
These rates don’t apply if Medicare pays you for preventive vaccines and their administration at reasonable cost (for example, Federally Qualified Health Centers (FQHCs), Rural Health Clinics (RHCs), and Hospital-based Renal Dialysis Facilities).

Providers may bill for the higher home payment rate when they furnish a COVID-19 monoclonal antibody product in a “home or residence.” This includes circumstances such as a Medicare patient’s permanent residence and temporary lodging (for example, hotel or motel, hostel, or homeless shelter).

Note:
During the COVID-19 PHE, providers could bill for the higher home payment rate for monoclonal antibody products they furnished in a home or residence that was made provider-based to the hospital. This policy ended on May 11, 2023.

If your Medicare patient’s permanent residence is a setting that provides health care services, such as an intermediate care facility, nursing facility, or SNF, that setting would also qualify as a “home or residence” for purposes of billing HCPCS codes M0241, M0244, M0246, M0248, or M0223. However, if the patient is only in that location temporarily (such as if your patient has a permanent home but is in a post-acute stay in a SNF), the setting isn’t considered a patient’s “home or residence” for this purpose, and you shouldn’t bill for these higher “at home” codes.

If you administer COVID-19 monoclonal antibodies to Medicare patients in traditional health care locations (for example, a hospital outpatient infusion clinic or freestanding infusion clinic), continue to bill HCPCS codes M0240, M0243, M0245, M0247, M0222, or M0224, as applicable. Inpatient locations, such as inpatient hospitals, inpatient psychiatric hospitals, long-term care hospitals, and inpatient rehabilitation hospitals, would never qualify as the “home or residence” for purposes of HCPCS codes M0241, M0244, M0246, M0248, or M0223.

Note:

Under the terms of their respective EUAs: ACTEMRA (tocilizumab) may only be infused in the hospital setting, in limited clinical situations PEMGARDA (pemivibart) should only be administered in settings in which health care providers have immediate access to medications to treat a severe hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary  Providers may not furnish ACTEMRA or PEMGARDA in the “home or residence." As a result, Medicare hasn’t created a separate HCPCS code for billing for the higher Medicare payment amount for administering ACTEMRA or PEMGARDA in the home.

Get the most current list of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products.

Payment Rates for Intramuscular Injection

Effective for services furnished on or after December 8, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through intramuscular injection for pre-exposure prophylaxis (such as EVUSHELD), in select patient populations, is approximately $150.50.

• This rate applies to all providers not paid reasonable cost for furnishing these products 
• The rate reflects information about the costs involved in administering monoclonal antibody products for different types of providers and the resources necessary to ensure providers administer the products safely and appropriately
• We geographically adjust the rate based on where you furnish the service

Payment Rates for Intramuscular Injection at Home

Effective for services furnished on or after December 8, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through intramuscular injection for pre-exposure prophylaxis (such as EVUSHELD), in select patient populations, in a patient’s home or residence, is approximately $250.50.

• This rate reflects information about the costs involved in furnishing these products in a patient’s home 
• For many providers, we also geographically adjust this rate based on where you furnish the service

Note:
These rates don’t apply if Medicare pays you for preventive vaccines and their administration at reasonable cost (for example, FQHCs, RHCs, and hospital-based renal dialysis facilities).

Providers may bill for the higher home payment rate when they furnish a COVID-19 monoclonal antibody product in a “home or residence.” This includes circumstances such as a Medicare patient’s permanent residence and temporary lodging (for example, hotel or motel, hostel, or homeless shelter).

If your Medicare patient’s permanent residence is a setting that provides health care services, such as an intermediate care facility, nursing facility, or SNF, that setting would also qualify as a “home or residence” for purposes of billing HCPCS code M0221. However, if the patient is only in that location temporarily (such as if your patient has a permanent home but is in a post-acute stay in a SNF), the setting isn’t considered a patient’s “home or residence” for this purpose, and you shouldn’t bill for this higher “at home” code.

If you administer these COVID-19 monoclonal antibody products in Medicare patients in traditional health care locations (for example, a hospital outpatient infusion clinic or freestanding infusion clinic), continue to bill HCPCS code M0220, as applicable. Inpatient locations, such as inpatient hospitals, inpatient psychiatric hospitals, long-term care hospitals, and inpatient rehabilitation hospitals, would never qualify as the “home or residence” for purposes of HCPCS code M0221.

Payment for Product

In response to the COVID-19 PHE, the government initially purchased the COVID-19 monoclonal antibody products and made them available for free. Medicare doesn’t pay for the COVID-19 monoclonal antibody products that providers get for free, including:

• Bebtelovimab (if you got the product for free)
• EVUSHELD (tixagevimab co-packaged with cilgavimab, administered as 2 separate consecutive intramuscular injections)
• REGEN-COV (casirivimab and imdevimab, administered together)
• Sotrovimab

The government won’t purchase the following products and make them available for free:

• ACTEMRA (tocilizumab)
• Bebtelovimab (starting August 15, 2022)
• PEMGARDA (pemivibart) 

Note:

CMS pays for ACTEMRA (tocilizumab) based on the number of units administered, so you should include the total number of units administered on the claim per day. For example, if you administer 200mg of ACTEMRA in 1 infusion, you should add 200 as the number of units on the claim. If you give 2 infusions in the same day, you should include the total units for both infusions with the product code Q0249 on 1 line (per day).

 

Note:

Starting August 15, 2022, bebtelovimab will be commercially available. You might have both U. S. Government (USG)-purchased and commercial product in your inventory.  For dates of service on or after August 15, 2022, only bill Medicare for the product if you use commercially purchased products. Don’t bill for USG-purchased products.  Continue to bill for administering either type of product. Check the Batch # on the vial. If the Batch # is D534422, the product was commercially purchased. Watch for Eli Lilly to release more information about future batch numbers.

CMS set the payment rate for COVID-19 monoclonal antibody products the same way we set the payment rate for COVID-19 vaccines. For example, Medicare will pay 95% of AWP for COVID-19 vaccines provided in the physician office setting and pay hospital outpatient departments at reasonable cost for COVID-19 vaccines. 

Get the most current payment allowances and effective dates for these products.

Billing

Billing for Administering COVID-19 Monoclonal Antibody Products

Health care providers can bill on a single claim for administering COVID-19 monoclonal antibody products, or submit claims on a roster bill.   

• The FDA approvals and EUAs for COVID-19 monoclonal antibody products contain specific requirements for administration that are considerably more complex than for other services that use roster billing. CMS expects health care providers to maintain appropriate medical documentation that supports the medical necessity of the service, including:
  • Documentation that supports that the provider met the terms of the approvals or EUAs
  • The name of the provider who ordered or decided to administer the infusion or injection, even in cases where providers use roster billing to submit claims for these services
• When the government provides COVID-19 monoclonal antibody products for free, you 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
• Medicare covers and pays for COVID-19 monoclonal antibodies under the Part B preventive vaccine benefit until the end of the year in which the HHS Secretary ends the EUA declaration for COVID-19 drugs and biologics.
• If you’re enrolled as a mass immunizer, you may be able to bill Medicare for administering monoclonal antibodies, consistent with the product’s FDA approval or EUA and in accordance with state law and scope of practice. 
• Mass immunizers may bill using a roster bill or a traditional claim form, such as a CMS-1500 (PDF) or the 837P electronic format. CMS systems will accept roster bills for 1 or more patients that get the same type of shot (or in the case of monoclonal antibodies, same type of infusion or injection) on the same date of service. 

• For Medicare Advantage (MA) plan patients (except for most MA hospice patients), submit claims for administering COVID-19 monoclonal antibody products to the MA plan. Original Medicare won’t pay these claims. 

  For most MA hospice patients, submit claims to Original Medicare. If your hospice patient’s MA plan participates in the Hospice Benefit Component of the Value-Based Insurance Design Model, submit claims for administering COVID-19 monoclonal antibody products to the MA plan. Original Medicare won’t pay these claims.

• Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
  • For Original Medicare patients, Medicare pays RHCs and FQHCs for administering COVID-19 monoclonal antibody products at 100% of reasonable cost through the cost report.
  • For MA patients, RHCs and FQHCs should submit claims for administering COVID-19 monoclonal antibody products to the MA plan. Original Medicare won’t pay these claims. To learn more about billing and payment, including MA wrap-around payments, visit the FQHC Center or review our FAQs (PDF). 

There’s No Cost for Your Patients

There’s no cost sharing for people with Medicare for COVID-19 monoclonal antibody products or their administration. This means your patients don't pay a copay/coinsurance or deductible:

• Through the end of the calendar year in which the EUA declaration ends, for monoclonal antibody products used for post-exposure prophylaxis or treatment of COVID-19
• Permanently for covered monoclonal antibody products used as pre-exposure prophylaxis for prevention of COVID-19