Rarely, some patients will have what's called an "infusion reaction," where they have itching and throat tightness it looks similar to an allergic reaction. This study showed a high prevalence of transient COVID-19 vaccine-related side-effects after primary and booster doses. These rates dont 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). Tardif JC, Bouabdallaoui N, L'Allier PL, Gaudet D, Shah B, Pillinger MH, Lopez-Sendon J, da Luz P, Verret L, Audet S, Dupuis J, Denault A, Pelletier M, Tessier PA, Samson S, Fortin D, Tardif JD, Busseuil D, Goulet E, Lacoste C, Dubois A, Joshi AY, Waters DD, Hsue P, Lepor NE, Lesage F, Sainturet N, Roy-Clavel E, Bassevitch Z, Orfanos A, Stamatescu G, Grgoire JC, Busque L, Lavalle C, Htu PO, Paquette JS, Deftereos SG, Levesque S, Cossette M, Nozza A, Chabot-Blanchet M, Dub MP, Guertin MC, Boivin G., COLCORONA Investigators. See Limitations of Authorized Use. You can decide how often to receive updates. Lenze EJ, Mattar C, Zorumski CF, Stevens A, Schweiger J, Nicol GE, Miller JP, Yang L, Yingling M, Avidan MS, Reiersen AM. means youve safely connected to the .gov website. 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 isnt considered a patients home or residence for this purpose, and you shouldnt bill for the higher at home HCPCS codes M0241, M0244,M0246, M0248, or M0223. The new rate reflects updated information about the costs involved in administering monoclonal antibody products for different types of providers and suppliersand the resources necessary to ensure providers administer the products safely and appropriately. How you take it: Via injection or IV and administered only in a health care setting by a health care professional. [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. Vaccines prevent progression for a larger part of the population. The most common side effects include allergic reactions, which include infusion related reactions, injection site reactions, brief pain, weakness and others. The authorized dose for REGEN-COV for. website belongs to an official government organization in the United States. The cause wasdemonstrated to be anovel coronavirus, called the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Inhaled budesonide for early treatment of COVID-19. Discuss with your healthcare provider any symptoms you are experiencing after treatment. The FDA approved or authorized under EUA the followingadditional 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: Under the terms of the FDA approval and EUA, health care providers may only administer ACTEMRA (tocilizumab) to hospitalized patients with severe COVID-19 illness. Therefore, you may not administer bebtelovimab to treat COVID-19 under the EUA until further notice. Monoclonal antibody therapy is indicated for use in non-hospitalized patients with mild to moderate disease who have risk factors for progression to severe disease. In the clinical trial, molnupiravir was given to study participants in four capsules twice a day for five daysstarting within five days after patients experienced the first symptoms of COVID-19.. COVID-19 vaccines protect against the SARS-CoV-2 virus only, so it's still important to keep yourself healthy and well. On January 21, 2022, the FDA approved a supplemental New Drug Application (NDA) for VEKLURY,which expanded its approval for use in the outpatient setting. A one-time dose of two long-acting monoclonal antibodies reduced the risk of developing symptomatic COVID by 77% in comparison with placebo ( P < .001) in a randomized, double-blind, placebo . Monoclonal antibody therapy has been suggested as an option for preventing progression to severe COVID-19 infection in high-risk individuals and reducing hospitalizations. The FDA provides the information regarding proper dosing, storage, handling, and administration on the fact sheets issued for healthcare providers on the emergency use authorization for the three monoclonal antibodies that are currently available. Healthcare providers should also educate the patients on the potential benefits of monoclonal antibody therapy for the treatment of COVID-19. Infusion-related reactions typically present after 30to 60 minutes after initiating the infusion. bleeding or infection at the injection site. In clinical trials, mAb (Casirivimab/Imdevimab) treatment reduced the risk of hospitalization by 50% in patients with mild to moderate COVID-19. 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. CMS geographically adjusts the rate based on where you furnish the service. Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens, such as viruses like SARS-CoV-2. The highly contagious nature of the virus and its high potential for morbidity and mortality has overwhelmed hospital systems worldwide with hospitalizations and deaths. [15]The virus gains entry into the cell by binding its spike protein to the angiotensin-converting enzyme 2 receptors on host cells. REGEN-COV (previously known as REGN-COV2), a combination of the monoclonal antibodies casirivimab and imdevimab, has been shown to markedly reduce the risk of hospitalization or death among. 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. [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. People who are overweight (with a BMI of 26 or greater). Injection site reactions and infusion-related reactions are the most commonly reported adverse events. 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. As a result, Medicare hasnt created a separate HCPCS code for billing for the higher Medicare payment amount for administering tocilizumab in the home. Monoclonal antibody therapy for COVID-19 is well tolerated with minimal risks. Previously authorized monoclonal antibodies had their authorizations revoked in January 2022 with the emergence of the Omicron variant. In most cases, your patients yearly Part B deductible and 20% co-insurance apply. Effective February 11, 2022, Medicare established separate coding and payment for administering COVID-19 monoclonal antibody products through IV injection in a patients home or residence. COVID-19 outbreak: history, mechanism, transmission, structural studies and therapeutics. Abbott is receiving monoclonal antibody treatment after testing positive for COVID-19. Tigecycline (TGC), a third-generation tetracycline, is characterized by a more potent and broad antibacterial activity, and the ability to overcome different mechanisms of tetracycline resistance. When the drug enters your bloodstream, it blocks the ability of the SARS-CoV-2 virus to . Davies NG, Abbott S, Barnard RC, Jarvis CI, Kucharski AJ, Munday JD, Pearson CAB, Russell TW, Tully DC, Washburne AD, Wenseleers T, Gimma A, Waites W, Wong KLM, van Zandvoort K, Silverman JD, CMMID COVID-19 Working Group. This means your patients don't pay a copay/coinsurance or deductible: Sign up to get the latest information about your choice of CMS topics. Choi JC, Kim WY. 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. Monoclonal antibody therapy reduces deaths and hospitalizations in non-hospitalized patients with risk factors for severe disease progression. The antibodies themselves are proteins, so giving them can sometimes cause something like an allergic reaction. Medicare Part B will provide payment 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. Diaz-Ordaz K, Keogh R, Eggo RM, Funk S, Jit M, Atkins KE, Edmunds WJ. Prajapat M, Handa V, Sarma P, Prakash A, Kaur H, Sharma S, Bhattacharyya A, Kumar S, Sharma AR, Avti P, Medhi B. Update on geographical variation and distribution of SARS-nCoV-2: A systematic review. [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). On December 23, 2022, the. [22] The EUA for sotrovimab is for a single dose of 500 mg IV.[12]. Evusheld therapy is made up of 1 injection of tixagevimab and 1 injection of cilgavimab, given separately into your muscle, one right after the other. It was developed in 2013 in plasma taken from a patient who had recovered from the 2003 Severe Acute Respiratory Syndrome virus (SARS). Managing Chemotherapy Side Effects: Achieving Reliable and Equitable Outcomes. [17], Like other RNA viruses, there is a high potential for mutation, and several variants of SARS-CoV-2 have been identified. Administration ofSotrovimab should occur within 10 days of symptom onset. 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, or M0222, as applicable. Our approach to paying for these products under the Part B preventive vaccine benefitduring the public health emergency (PHE) allows a broad range of providers and suppliers to administer these products, including but not limited to: To help skilled nursing facilities (SNFs) efficiently administer COVID-19 vaccines (including COVID-19 monoclonal antibody products) 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). Some people report mild side effects, like headache or stomach upset/nausea. In August, Florida launched the first mobile unit to provide monoclonal antibody treatments for coronavirus patients. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or. After receiving monoclonal antibody therapy, the patient must continue self-isolating and use infection control measures such as social distancing, frequent handwashing, mask-wearing, cleaning, and disinfecting high-touch surfaces to the CDC. 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. These are not all the possible side effects. [27], Analysis by Stokes et al. 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 Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial. Salian VS, Wright JA, Vedell PT, Nair S, Li C, Kandimalla M, Tang X, Carmona Porquera EM, Kalari KR, Kandimalla KK. These antibodies are typically. [25][26]One percentof the patients who received sotrovimab had infusion-related reactions. Pregnant people. Monoclonal antibodies, . Monoclonal antibodies are lab-made proteins that mimic the immune system's ability to fight off viruses and other harmful pathogens, per the FDA. 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. 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. During this interim time, well maintain the administration payment amounts when you infuse or inject these products in health care settings and in the home, as described below. Monoclonal antibodies used for the treatment of COVID-19 target the viral spike protein, which prevents viral entry. This is a kind of protein that can lock onto and disable a virus or "antigen." A successful antibody does usually one of two things: It blocks the virus from entering cells, and. Sotrovimab targets a highly conserved epitope of the RBD that is present across the entire family of SARS-like coronaviruses. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. [21], The major benefits derived from the monoclonal antibody therapies appear to be a reduction in viral load, hospitalizations, and death. 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. This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. [23][24]Infusion-related reactions are characterized by flushing, fever/chills, back or abdominal pain, nausea/vomiting, pruritus, or skin rashes. The effective management of COVID-19 with monoclonal antibodies and ensuring patient safety requires the coordinated efforts of an interprofessional healthcare team, including clinicians (MDs, DOs, NPs, PAs), specialists (e.g., infectious disease specialists, virologists), pharmacists, nurses, and medical assistants. The interprofessional healthcare team is also responsible for educating the patient on infection control measures. Flu-like symptoms (fever, sweating, chills, cough, sore throat, headache or muscle pain) Upset stomach (nausea, vomiting or diarrhea) Itching, swelling, rash or hives. Tixagevimab and cilgavimab are long-acting monoclonal antibodies meant to directly target the spike protein of SARS-CoV-2 and block the virus' attachment to and invasion of your cells. StatPearls Publishing, Treasure Island (FL). For dates of service on or after August 15, only bill Medicare if you use commercially-purchased products. For most Medicare Advantage hospice patients, submit claims to Original Medicare. Gao YD, Ding M, Dong X, Zhang JJ, Kursat Azkur A, Azkur D, Gan H, Sun YL, Fu W, Li W, Liang HL, Cao YY, Yan Q, Cao C, Gao HY, Brggen MC, van de Veen W, Sokolowska M, Akdis M, Akdis CA. Monoclonal antibodies (mAbs) are now established as targeted therapies for malignancies, transplant rejection, autoimmune and infectious diseases, as well as a range of new indications. At high risk of dying from the virus, Barron remains a virtual prisoner in her . For many providers and suppliers, we also geographically adjust this rate based on where you furnish the service. Therefore, you may not administersotrovimabto treat COVID-19 under the EUA until further notice. Learn more about what to do if you are sick. A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. Treatment Locator A monoclonal antibody (mAb) is a type of immune protein produced in a lab that binds to a specific protein on a cell called an antigen . 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. Learn more about treatment guidelines and recommendations for using monoclonal antibody therapies. On January 24, 2022, the FDA announced that, REGEN-COV (casirivimab and imdevimab, administered together) (EUA issued November 21, 2020, latest update January 24, 2022). People at risk of getting very sick from COVID-19 include: People who are age 65 or older. Side effects can range from mild to serious and may include: Wheezing or trouble breathing. pain. The FDA authorized the following investigational monoclonal antibody product underEUA for pre-exposure prophylaxis of COVID-19: EVUSHELDTM(tixagevimab co-packaged with cilgavimab) (EUA issued December 8, 2021, latest update January 26, 2023). Healthcare providers must also educate the patient on symptoms that mark progression to severe disease and prompt the patient to return for reevaluation. 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 tixagevimab co-packaged with cilgavimab, administered as 2 separate consecutive intramuscular injections), in select patient populations, is approximately $150.50. Monoclonal antibody therapy is a way of treating COVID-19 for people who have tested positive, have had mild symptoms for seven days or less, and are at high risk for developing more serious symptoms. The FDA has authorized additional treatments for emergency use. The federal government isnt purchasing VEKLURY. If your Medicare patients 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 billingcodes M0221. [2][3][4]At this time, however, there is minimal data that suggests these therapies improve outcomes. The chances of any of these side effects occurring after vaccination differ according to the specific vaccine. Adverse Reactions Shepard HM, Phillips GL, D Thanos C, Feldmann M. Developments in therapy with monoclonal antibodies and related proteins. Providers should also review the CDC website which provides information from state and local health authorities that report viral variants in the region, which will help guide treatment decisions. With the dominance of this variant in the United States and the lack of readily available testing to identify the infecting variant, the FDA recommended against the use of any monoclonal antibody at this time except sotrovimab. 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 Monoclonal antibodies may block the SARS-CoV-2 virus from attaching to human cells and help neutralize the virus (meaning they stop the virus from replicating). There is an unpublished study for sotrovimab, which also shows a reduction in hospitalization and death. However, these side-effects waned within 48 h. Pain at the injection site was the most common local side-effect, while fatigue, fever, headache and muscle pain were frequently repo 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. On November 30, 2022, the, The patient has a positive COVID-19 test result, The patient is at high risk for progressing to severe COVID-19, hospitalization, or both, Immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, The ability to activate the emergency medical system (EMS), Refer to information from your state and local health authorities, REGEN-COV (casirivimab and imdevimab, administered together) (not currently authorized in any U.S region), Bamlanivimab and etesevimab, administered together(not currently authorized in any U.S region), Sotrovimab(not currently authorized in any U.S. region), Freestanding and hospital-based infusion centers, Entities with whom nursing homes contract to administer products, 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, M0245 when billing to administer in a health care setting, M0246 when billing to administer in the home or residence, Consistent with existing payment methodologies for the care setting where you provide the treatment, Casirivimab and imdevimab, to be administered together, Bamlanivimab and etesevimab, to be administered together, Tixagevimab co-packaged with cilgavimab, administered as 2 separate consecutive intramuscular injections, Bebtelovimab (if you got the product for free). 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, Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs), Through the end of the calendar year in which the EUA declaration ends for monoclonal antibody products used for post-exposure prophylaxis or for treatment of COVID-19, Permanently for covered monoclonal antibody products used as pre-exposure prophylaxis for prevention of COVID-19. COVID-19 Transmission, Current Treatment, and Future Therapeutic Strategies. There may not be data from patients, but lab studies strongly suggest the treatments will not help omicron-infected people. While the initial data regarding monoclonal antibodies in the treatment of COVID-19 appears promising, at this time, thebulk ofthis data is preliminary and unpublished and has not been peer-reviewed. Monoclonal antibody treatments are infusions of lab-made proteins that mimic the immune system's ability to fight off COVID. As mentioned above,the FDA revoked its authorizations for previously authorized monoclonal antibodies as they did not maintain efficacy against the Omicron variant. Beginning on May 6, 2021, Medicare established separate coding and payment for administering COVID-19 monoclonal antibody products through infusion in a patients home or residence. COVID-19 Genomics UK (COG-UK) Consortium. The interprofessional healthcare team must be familiar with the dosages and methods of administering monoclonal antibodies. Monoclonal antibodies prevent progression to severe disease, are not equally effective across variants, and are associated with minimal and self-limited reactions. See the Federal Register announcement for more information about the revoked EUA and NDA approval. Coronavirus Disease 2019 Case Surveillance - United States, January 22-May 30, 2020. 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 patients home or residence is approximately $550.50. Get the most current payment allowances and effective dates for these products. [9][10][11]The only monoclonal antibody currently authorized for emergency use in the United States by the FDA is sotrovimab. This likely will bring more attention to this treatment, which has proven to cut . The July 30, 2021, revised EUA for casirivimab and imdevimab 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. The U.S. Food and Drug Administration has authorized treatments that have already been taken by millions of people, reducing their COVID-19 symptoms and keeping many of them out of the hospital. 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 COVID-19 monoclonal antibody products, authorized or approved by the FDA, is approximately $350.50. Benefits And Risks Of Administering Monoclonal Antibody Therapy For Coronavirus (COVID-19) [Updated 2022 Apr 28]. Monoclonal antibody therapy is indicated for use in non-hospitalized patients with mild to moderate disease who have risk factors for progression to severe disease. Share sensitive information only on official, secure websites. People who had severe illness with COVID-19 might experience organ damage affecting the heart, kidneys, skin and brain. This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. Effective January 1 of the year after that in which the EUA declaration ends: On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. 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 isnt considered a patients home or residence for this purpose, and you shouldnt bill for the higher at home HCPCS code M0221. These are not all the possible side effects of this medication, which has not been given to a lot of people. No dosing adjustments are recommended for patients based on renal impairment, pregnancy, or lactation status. [7] On November 30, 2022, the FDA announced that bebtelovimab isnt currently authorized in any U.S. region because it isnt expected to neutralize Omicron sub-variants BQ.1 and BQ.1.1. Identify the potential adverse reactions to monoclonal antibody therapy in the management of outpatient COVID-19. This activity outlines the indications, actions, contraindications, and adverse events for monoclonal antibody therapy as a valuable treatment for outpatient COVID-19 infections. Theres no cost sharing for people with Medicare for COVID-19 monoclonal antibody products or their administration. Monoclonal antibodies are intended to trigger the immune system and, in doing so, the body may respond with flu-like symptoms. There are now 21 clinics around the state, including two in South Florida in Broward and Miami . Side effects may occur from mAbs treatment including rash, diarrhea, nausea, dizziness and pruritis (itchy skin). Monoclonal antibodies are laboratory-made "substitute antibodies" that can help the immune system recognize and respond more effectively to COVID-19, according to the U.S. Food and Drug. Monoclonal antibodies are proteins developed in a lab in order to fight off infections that our bodies aren't familiar with, like COVID-19. http://creativecommons.org/licenses/by-nc-nd/4.0/ [20], Sotrovimab, also called VIR-7831, is the only monoclonal antibody currently authorized for use. Then, your dose will be reduced to 300 mg every other week. An EUA for casirivimab and imdevimab for COVID-19. 1 Monoclonal antibodies, like most medications, carry risks and side effects that you and your doctor need to weigh against any possible benefits. According to Public Health England, most side-effects from two Covid vaccines - Pfizer/BioNTech and Oxford/AstraZeneca - are mild and short-lived. Prevention and early treatment for eligible patients can help improve patient outcomes, reduce stress on healthcare facilities, and even save lives. Lpez-Medina E, Lpez P, Hurtado IC, Dvalos DM, Ramirez O, Martnez E, Dazgranados JA, Oate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendao AC, Toro DF, Torres M, Lesmes MC, Rios CA, Caicedo I. CMS created HCPCS code J0248 for VEKLURY, effective December 23, 2021. For outpatients, the treatment is a three-day course of infusions that must be initiated within seven days of symptom onset. 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). or Remdesivir is an antiviral drug approved by the FDA for the treatment of COVID-19 in hospitalized adults and hospitalized pediatric patients at least 12 years of age. Get the most currentlist of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products.
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