Covid antibody infusion protocol

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Monoclonal Antibody COVID-19 Infusion

Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction, coding, and billing information.

Issued by: Centers for Medicare & Medicaid Services (CMS)

The COVID-19 public health emergency (PHE) ended at the end of the day on May 11, 2023. View Infectious diseases for a list of waivers and flexibilities that were in place during the PHE.

Review this page for information about Medicare payment for administering monoclonal antibodies during and after the PHE.

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 website 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's letter for more information about the revoked EUA and NDA approval.

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% co-insurance 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:

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:

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

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

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

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

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 the following:

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:

How to Order COVID-19 Monoclonal Antibodies

Eligible administration sites must coordinate with their respective state or territorial health department to order these COVID-19 monoclonal antibodies:

The federal government isn't distributing the following products; you may purchase them through typical purchasing channels:

Medicare & COVID-19 Monoclonal Antibody Products

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 respective approvals or EUAs) the same way it covers and pays for COVID-19 vaccines 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.

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:

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:

Coding for the Administration of COVID-19 Monoclonal Antibody Products

CMS identified specific code(s) for each COVID-19 monoclonal antibody product and specific administration code(s) for Medicare payment:

EUA Effective & Revocation Date(s)

November 10, 2020 - April 16, 2021

Note: On April 16, 2021, the FDA revoked the EUA for bamlanivimab when administered alone.

Long descriptor: Injection, bamlanivimab-xxxx, 700 mg

Short descriptor: Bamlanivimab-xxxx

Long descriptor: Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring

Short descriptor: Bamlanivimab-xxxx infusion

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

Long descriptor: Injection, casirivimab and imdevimab, 600 mg

Short descriptor: Casirivi and imdevi 600 mg

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

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

Long descriptor: Injection, casirivimab and imdevimab, 600 mg

Short descriptor: Casirivi and imdevi 600 mg

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

Note: This product isn’t currently authorized [1]

November 21, 2020 - TBD

Long descriptor: Injection, casirivimab and imdevimab, 2400 mg

Short descriptor: Casirivimab and imdevimab

Long descriptor: Injection, casirivimab and imdevimab, 1200 mg

Short descriptor: Casirivi and imdevi 1200 mg

Long descriptor: Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or injection, and post administration monitoring

Short descriptor: Casirivi and imdevi inj

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

Long descriptor: Injection, casirivimab and imdevimab, 2400 mg

Short descriptor: Casirivimab and imdevimab

Long descriptor: Injection, casirivimab and imdevimab, 1200 mg

Short descriptor: Casirivi and imdevi 1200 mg

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

Note: This product isn’t currently authorized [1]

February 9, 2021 - TBD

Long descriptor: Injection, bamlanivimab and etesevimab, 2100 mg

Short descriptor: Bamlanivimab and etesevima

Long descriptor: Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring

Short descriptor: Bamlan and etesev infusion

Note: This product isn’t currently authorized [1]

February 9, 2021 (reissued on February 25, 2021) – TBD

Note: While the product EUA was issued on February 9, 2021, this administration code is effective May 6, 2021

Long descriptor: Injection, bamlanivimab and etesevimab, 2100 mg

Short descriptor: Bamlanivimab and etesevima

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

Note: This product isn’t currently authorized [6]

May 26, 2021 - TBD

Long descriptor: Injection, sotrovimab, 500 mg

Short descriptor: Sotrovimab

Long descriptor: Intravenous infusion, sotrovimab, includes infusion and post administration monitoring

Short descriptor: Sotrovimab infusion

Note: This product isn’t currently authorized [6]

May 26, 2021 - TBD

Long descriptor: Injection, sotrovimab, 500 mg

Short descriptor: Sotrovimab

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

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

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

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

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

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

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

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

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

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

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

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

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

Note: This product isn’t currently authorized [7]

February 11, 2022 - TBD

Long descriptor: Injection, bebtelovimab, 175 mg

Short descriptor: Bebtelovimab 175 mg

Long descriptor: Intravenous injection, bebtelovimab, includes injection and post administration monitoring

Short descriptor: Bebtelovimab injection

Note: This product isn’t currently authorized [7]

February 11, 2022 - TBD

Long descriptor: Injection, bebtelovimab, 175 mg

Short descriptor: Bebtelovimab 175 mg

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

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

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.

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 Medicare Part B 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, as described below.

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

Payment Rates for Infusion

On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. 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.

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 .

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:

The September 16, 2021, revised EUA for bamlanivimab and etesevimab allows for its use for PEP in certain adult and pediatric patients. Continue to use the same codes to bill for administering bamlanivimab and etesevimab for PEP and treatment:

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.

More Information about Payment for Infusion & IV Injection

Medicare also pays for treatment to address major complications:

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.

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.

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.

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 skilled nursing facility, that setting would also qualify as a “home or residence” for purposes of billing 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 skilled nursing facility), the setting isn’t considered a patient’s “home or residence” for this purpose, and you shouldn’t bill for the higher “at home” HCPCS codes M0241, M0244, M0246, M0248, or M0223.

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.

Under the terms of the ir respective EUA s:

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.

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.

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.

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 skilled nursing facility, that setting would also qualify as a “home or residence” for purposes of billing codes 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 skilled nursing facility), the setting isn’t considered a patient’s “home or residence” for this purpose, and you shouldn’t bill for the higher “at home” HCPCS code M0221.

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:

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

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).

Starting August 15, 2022, bebtelovimab will be commercially available. You might have both United States Government (USG)-purchased and commercial product in your inventory.

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.

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.