Monoclonal Antibody COVID-19 Infusion
Monoclonal Antibody Products to Treat COVID-19
The following the investigational monoclonal antibody therapies are available under FDA emergency use authorization (EUA):
- Casirivimab and imdevimab, administered together (EUA issued November 21, 2020)
- Bamlanivimab and etesevimab, administered together (EUA issued February 9, 2021)
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:
- The patient has a positive COVID-19 test result
- The patient is 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 of these:
- Immediate access to medications to treat a severe infusion reaction, such as anaphylaxis
- The ability to activate the emergency medical system (EMS)
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:
- Fact Sheet for Health Care Providers EUA of Casirivimab and Imdevimab
- Fact Sheet for Health Care Providers EUA of Bamlanivimab and Etesevimab
Important Update about Viral Variants
On April 16, 2021, the FDA revoked the EUA for bamlanivimab, when administered alone, due to a sustained increase in COVID-19 viral variants in the U.S. that are resistant to the solo product.
Importantly, although the FDA revoked the EUA for bamlanivimab, when administered alone, alternative monoclonal antibody therapies remain available under EUA, including REGEN-COV (casirivimab and imdevimab, administered together), and bamlanivimab and etesevimab, administered together, for the same uses as previously authorized for bamlanivimab alone. The FDA indicates that alternative monoclonal antibody therapies remain appropriate to treat COVID-19 patients, and health care providers may continue using these authorized therapies:
- Casirivimab and imdevimab, administered together
- Bamlanivimab and etesevimab, administered together
The FDA indicates using these other therapies may reduce the risk of treatment failure for patients infected with a COVID-19 viral variant that’s resistant to bamlanivimab when administered alone. For details about specific variants and resistance, review the Antiviral Resistance information in Section 15 of each of the Fact Sheets listed above.
Following your existing ordering and reporting procedures, you can still order the following from the authorized distributor:
- Casirivimab and imdevimab, to be administered together
- Bamlanivimab and etesevimab, to be administered together
You can also order etesevimab alone to pair with your current supply of bamlanivimab.
For more information about viral variants in your area to help you make treatment decisions:
- Visit the CDC’s website on Variant Proportions in the U.S.
- Refer to information from your state and local health authorities
Medicare Coverage for Monoclonal Antibody Products to Treat COVID-19
During the COVID-19 public health emergency (PHE), Medicare will cover and pay for these infusions (when furnished consistent with their respective EUAs) the same way it covers and pays for COVID-19 vaccines.
|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 as COVID-19 vaccines during the PHE 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
To help skilled nursing facilities (SNFs) efficiently administer COVID-19 vaccines (including monoclonal antibody products to treat COVID-19) to residents, CMS has exercised enforcement discretion for certain statutory provisions and any associated statutory references and implementing regulations, including as interpreted in pertinent guidance (collectively, “SNF Consolidated Billing Provisions”). We allow Medicare-enrolled immunizers including, but not limited to, pharmacies working with the U.S., infusion centers, and home health agencies to bill directly and get direct payment from the Medicare Program for vaccinating Medicare SNF residents.
Health care providers administering the infusions of monoclonal antibody products to treat COVID-19 will follow the same enrollment process as those administering the COVID-19 vaccines. Get provider enrollment information.
Coding for Monoclonal Antibody Products to Treat COVID-19
CMS identified specific code(s) for each monoclonal antibody product to treat COVID-19 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
November 21, 2020 - TBD
Long descriptor: Injection, casirivimab and imdevimab, 2400 mg
Short descriptor: casirivimab and imdevimab
Long Descriptor: intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring
Short Descriptor: casirivi and imdevi infusion
|Regeneron’s Antibody casirivimab and imdevimab (REGN-COV2) (ZIP)||
November 21, 2020 – TBD
Long descriptor: Injection, casirivimab and imdevimab, 2400 mg
Short descriptor: casirivimab and imdevimab
Long Descriptor: intravenous infusion, casirivimab and imdevimab 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: casirivi and imdevi infus hm
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
|Eli Lilly and Company’s Antibody Bamlanivimab and Etesevimab, (ZIP)||
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.
Medicare Payment for Administering Monoclonal Antibody Products to Treat COVID-19
To ensure immediate access during the COVID-19 PHE, Medicare covers and pays for these infusions in accordance with Section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). We'll address potential refinements to payment for administering monoclonal antibody products to treat COVID-19 through future notice-and-comment rulemaking.
Payment 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 new Medicare payment rate for administering COVID-19 monoclonal antibody products, authorized or approved by the FDA, is approximately $450. This rate applies to all providers and suppliers 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 suppliers, and the additional resources necessary to ensure providers administer the products safely and appropriately to COVID-19 positive patients. CMS geographically adjusts the rate based on where you furnish the service.
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.
Payment for Infusion at Home
Beginning on May 6, 2021, Medicare established separate coding and payment for administering COVID-19 monoclonal antibody products in a patient’s home or residence. Effective for services furnished on or after May 6, 2021, the new Medicare payment rate for administering monoclonal antibody products 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 and suppliers, CMS also geographically adjusts this rate based on where you furnish the service.
Providers and suppliers 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, temporary lodging (for example, hotel or motel, hostel, or homeless shelter), and homes or residences that have been made provider-based to the hospital during the COVID-19 PHE.
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 these codes (M0244, M0246). 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,” and you shouldn’t bill for the higher “at home” HCPCS codes M0244 or M0246.
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 M0243 or M0245, 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 M0244 or M0246.
Payment for Product
In response to the COVID-19 PHE, the government is initially purchasing the monoclonal antibody products to treat COVID-19 and making them available for free. Medicare won’t pay for the monoclonal antibody products to treat COVID-19 that providers get for free. If providers begin to purchase monoclonal antibody products, CMS anticipates setting the payment rate 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. Because CMS considers monoclonal antibody products to treat COVID-19 to be COVID-19 vaccines, they aren’t eligible for the New COVID-19 Treatments Add-on Payment (NCTAP) under the Inpatient Prospective Payment System (IPPS).
When providers begin to purchase these products, we’ll publish a list of payment allowances and effective dates for the products.
There’s No Cost for Your Patients
There’s no cost sharing for people with Medicare for these monoclonal antibody products to treat COVID-19:
- No copayment/coinsurance
- No deductible
Billing for Administering Monoclonal Antibody Products to Treat COVID-19
Health care providers can bill on a single claim for administering monoclonal antibody products to treat COVID-19, or submit claims on a roster bill.
- The EUAs for monoclonal antibody products to treat COVID-19 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 EUAs
- The name of the provider who ordered or decided to administer the infusion, even in cases where providers use roster billing to submit claims for these services
- 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 the claim.
- To ensure access during the PHE, Medicare covers and pays for COVID-19 monoclonal antibodies under the COVID-19 vaccine benefit.
- If you’re enrolled as a mass immunizer, you may be able to bill Medicare for administering monoclonal antibodies, consistent with the product’s 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) on the same date of service.
- For patients enrolled in a Medicare Advantage Plan in 2020 and 2021, submit claims for monoclonal antibody products to treat COVID-19 to Original Medicare through your Medicare Administrative Contractor (MAC). Use your patients’ Medicare Beneficiary Identifiers (MBI) to bill Original Medicare.
- Ask your Medicare Advantage patients for their Original Medicare card. All Medicare patients have a red, white, and blue Medicare card with an MBI, including those enrolled in a Medicare Advantage Plan.
- If your patients don’t have their Original Medicare card or don’t know their MBI, use the MBI look-up tool in your MAC’s secure portal (PDF). You’ll need your patients’ first names, last names, dates of birth, and SSNs. You can use the MAC’s secure portal to look up the MBI for your Medicare patients even if they’re enrolled in a Medicare Advantage Plan.
- For Part A claims, include Condition Code (CC) 78.