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. These rates dont apply if Medicare pays you for preventive vaccines and their administration at reasonable cost (for example, FQHCs, RHCs, and hospital-based renal dialysis facilities). When the government provides COVID-19 monoclonal antibody products for free, providers should only bill for the administration; dont include the monoclonal antibody product codes on these claims. pain. Possible side effects of COVID-19 monoclonal antibodies can include: nausea or vomiting diarrhea fever or chills drop in blood pressure headache or dizziness muscle pains or aches itching. All adverse events related to monoclonal antibody treatment must be reported according to the instructions found in the fact sheets released by the FDA. Continue to use the same codes to bill for administering bamlanivimab and etesevimab for PEP and treatment: Effective February 11, 2022, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products by intravenous (IV) injection. Bamlanivimab and etesevimab, administered together (EUA issued February 9, 2021, latest update January 24, 2022). The rate reflects information about the costs involved in administering monoclonal antibody products for different types of providers and suppliers and the resources necessary to ensure providers administer the products safely and appropriately. Mass immunizers may bill using a roster bill or a traditional claim form, such as a, Enrollment for Administering COVID-19 Vaccine Shots, Medicare Billing for COVID-19 Vaccine Shot Administration, SNF: Enforcement Discretion Relating to Certain Pharmacy Billing, Beneficiary Incentives for COVID-19 Vaccine Shots, CMS Quality Reporting for COVID-19 Vaccine Shots, New COVID-19 Treatments Add-On Payment (NCTAP), FDA approved a supplemental New Drug Application (NDA) for VEKLURY, FDA announced approval of a new indication for ACTEMRA, FDA announced that bebtelovimab isnt currently authorized in any U.S. region, treatment guidelines and recommendations for using monoclonal antibody therapies, Fact Sheet for Health Care Providers EUA of ACTEMRA(tocilizumab) (ZIP), Fact Sheet for Health CareProvidersEUA of Bamlanivimab and Etesevimab, Fact Sheet for Health Care Providers EUA for EVUSHELD (tixagevimab co-packaged with cilgavimab) (ZIP), Fact Sheet for Health CareProvidersEUA of REGEN-COV (casirivimab and imdevimab) (PDF), Fact Sheet for Health Care Providers EUA of Sotrovimab, ordering process and reporting requirements, Genentechs Antibody ACTEMRA (tocilizumab, AstraZenecas Antibody EVUSHELD (tixagevimab and Cilgavimab), most currentlist of billing codes, payment allowances, and effective dates, Section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), most current geographically adjusted rates, most current list of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products, most currentlist of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products, New COVID-19 Treatments Add-on Payment (NCTAP), most current payment allowances and effective dates for these products. They are considered a promising approach in managing nonhospitalized patients with mild to moderate COVID-19 who are at high risk of developing severe illness. As the COVID-19 pandemic has overwhelmed hospital systems worldwide, the need arose for outpatient therapies and strategies to decrease hospitalizations and identify patients at risk for developing severe diseases. CMS will continue to pay for COVID-19 monoclonal antibodies for post-exposure prophylaxis or for treatment of COVID-19 under the Medicare Part B vaccine benefit through the end of the calendar year in which the EUAdeclaration for COVID-19 drugs and biologicalsends. Xia ZN, Cai XT, Cao P. Monoclonal antibody: the corner stone of modern biotherapeutics. bruising of the skin. 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). This rate reflects updated information about the costs involved in furnishing these complex products in a patients home. website belongs to an official government organization in the United States. If the Batch # is D534422, the product was commercially-purchased. The chances of any of these side effects occurring after vaccination differ according to the specific vaccine. Sotrovimab is not authorized for subcutaneous administration. 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 circumstancessuch as a Medicare patients 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. Hoffmann M, Kleine-Weber H, Schroeder S, Krger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Mller MA, Drosten C, Phlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. A recent study found that autoantibodies that existed before infection with SARS-CoV-2 may account for 20% or more of serious or fatal COVID-19 cases. It targets the RBD of the SARS-CoV-2 spike protein. [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. Common side effects of monoclonal antibodies include: Allergic reactions Chills Weakness Diarrhea Nausea Vomiting Rash Itching High blood glucose levels Cough Constipation Other side effects of monoclonal antibodies include: Shortness of breath Peripheral edema Headache Fever Muscle aches and pain Decreased appetite Increased triglyceride levels [18]These variations have key mutations in the spike protein of the virus, and in some cases, such as the UK variant, make the virus 43to 82% more transmissible. For more information about billing and payment for VEKLURY in the outpatient setting: Monoclonal Antibodies for Pre-Exposure Prophylaxis of COVID-19. Paul F, Cartron G. Infusion-related reactions to rituximab: frequency, mechanisms and predictors. CMS pays for tocilizumab based on the number of units administered, so you should include the total number of units administered on the claim per day. The antibodies themselves are proteins, so giving them can sometimes cause something like an allergic reaction. The most common side effects include allergic reactions, which include infusion related reactions, injection site reactions, brief pain, weakness and others. At high risk of dying from the virus, Barron remains a virtual prisoner in her . This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. For outpatients, the treatment is a three-day course of infusions that must be initiated within seven days of symptom onset. Monoclonal antibodies used for the treatment of COVID-19 target the viral spike protein, which prevents viral entry. The interprofessional healthcare team must be familiar with the dosages and methods of administering monoclonal antibodies. 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. We geographically adjust the rate based on where you furnish the service. Therefore, you may not administersotrovimabto treat COVID-19 under the EUA until further notice. [12]The full results of this study were published in October 2021. Then, your dose will be reduced to 300 mg every other week. [9][10][11]The only monoclonal antibody currently authorized for emergency use in the United States by the FDA is sotrovimab. ( 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). Not many people have received bebtelovimab. Check the Batch # on the vial. See the, Fact Sheet for Health Care Providers EUA of Bebtelovimab, EVUSHELD (tixagevimab co-packaged with cilgavimab), administered as 2 separate consecutive intramuscular injection, (not currently authorized in any U.S. region), 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, 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, 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 beneficiarys home that has been made provider-based to the hospital during the covid-19 public health emergency, Intravenous injection, bebtelovimab, includes injection and post administration monitoring, Intravenous injection, bebtelovimab, includes injection and post administration monitoring in the home or residence; this includes a beneficiarys home that has been made provider-based, CMS will pay you for monoclonal antibody products usedfor post-exposure prophylaxis or for treatment of COVID-19 as biological products paid under, When you administermonoclonal antibodies for post-exposure prophylaxis or for treatment of COVID-19, CMS will pay you under the applicable payment system, 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 vaccine benefit even after the EUA declaration ends, The FDA approval and EUA for ACTEMRA also allows for 2 infusions for the same patient in limited situations.