( Stokes EK, Zambrano LD, Anderson KN, Marder EP, Raz KM, El Burai Felix S, Tie Y, Fullerton KE. Benefits And Risks Of Administering Monoclonal Antibody Therapy For Coronavirus (COVID-19) [Updated 2022 Apr 28]. Infusion-related reactions are potential adverse reactions when administering monoclonal antibodies and are common with drugs such as rituximab. Get the most current list of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products. For details about specific variants and monoclonal antibody resistance, review the Antiviral Resistance information in each of the Fact Sheets listed above. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. Most infusion-related reactions are self-limited and treated by stopping the infusion and symptomatic treatment. Healthcare providers and scientists are investigating . [5][6], Monoclonal antibodies have been identified as a potential therapy to prevent disease progression in patients at risk for severe disease. 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. The FDA approval and EUA for ACTEMRA also allows for 2 infusions for the same patient in limited situations. Possible side effects can include: Fever Chills Weakness Headache Nausea Vomiting Diarrhea Low blood pressure The cause wasdemonstrated to be anovel coronavirus, called the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). An official website of the United States government Typical side effects include pain at the injection site, fever, fatigue, headache, muscle pain, chills and diarrhoea. Side effects may occur from mAbs treatment including rash, diarrhea, nausea, dizziness and pruritis (itchy skin). CMS geographically adjusts the rate based on where you furnish the service. 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. In August, Florida launched the first mobile unit to provide monoclonal antibody treatments for coronavirus patients. Evusheld is the only non-vaccine with emergency use authorization (EUA) from the FDA to prevent infection from COVID-19 before you're exposed to the virus. 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. 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 . They seek out the antigens (foreign materials) and stick to them in order to destroy them. 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. Side effects: Nausea is the most common side effect. See theEUAfor more information. CMS geographically adjusts the rate based on where you furnish the service. 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. https:// Scientists have wondered if infection with SARS-CoV-2 could also result in the production of autoantibodies in people who didn't have them before they got sick. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. [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. 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. Healthcare providers must be able to recognize patients at risk for progression to severe disease who would benefit from monoclonal antibody infusion and recognize which patients must be hospitalized for severe infection. Monoclonal antibodies targeting the spike protein of the SARS-CoV-2 have yielded positive in vitro results. In the same patient population, mortality was also greatly increased compared to younger healthy individuals (19.5% vs. [13][12][14]It has been proposedthat monoclonal antibodies may be associated with worse outcomes for patients requiring high-flow oxygen or mechanical ventilation; however, this is largely unstudied, and there is a lack of data that confirms this. Inhaled budesonide for early treatment of COVID-19. For more information about viral variants in your area to help you make treatment decisions: Eligible administration sites must coordinate with their respective state or territorial health department to order these COVID-19 monoclonal antibodies: Get more information on the ordering process and reporting requirements. Lenze EJ, Mattar C, Zorumski CF, Stevens A, Schweiger J, Nicol GE, Miller JP, Yang L, Yingling M, Avidan MS, Reiersen AM. Monoclonal antibodies are proteins developed in a lab in order to fight off infections that our bodies aren't familiar with, like COVID-19. Bamlanivimab (EUA issued November 9, 2020, EUA revoked April 16, 2021). 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. Monoclonal antibodies are intended to trigger the immune system and, in doing so, the body may respond with flu-like symptoms. Flu-like symptoms (fever, sweating, chills, cough, sore throat, headache or muscle pain) Upset stomach (nausea, vomiting or diarrhea) Itching, swelling, rash or hives. Brobst B, Borger J. [21], The major benefits derived from the monoclonal antibody therapies appear to be a reduction in viral load, hospitalizations, and death. The safety and side effects of monoclonal antibodies. A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19. Shepard HM, Phillips GL, D Thanos C, Feldmann M. Developments in therapy with monoclonal antibodies and related proteins. Swollen lips, face or throat. 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. Learn more about treatment guidelines and recommendations for using monoclonal antibody therapies. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Beaver CC, Magnan MA. Monoclonal antibodies are one such treatment that may . 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. COVID-19 therapeutics can be used to prevent or treat eligible non-hospitalized patients who have tested positive for COVID-19 and have mild to moderate symptoms. [6] On April 5, 2022, the FDA announced that, due to the high frequency of the Omicron BA.2 sub-variant, sotrovimab isnt currently authorized in any U.S. region. It was developed in 2013 in plasma taken from a patient who had recovered from the 2003 Severe Acute Respiratory Syndrome virus (SARS). These antibodies were identified by analyzing convalescent plasma obtained from patients infected with COVID-19. The most common side effects include allergic reactions, which include infusion related reactions, injection site reactions, brief pain, weakness and others. Some people report mild side effects, like headache or stomach upset/nausea. 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. Managing Chemotherapy Side Effects: Achieving Reliable and Equitable Outcomes. Official websites use .govA [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. Under the terms of the FDA approval and EUA, health care providers can only administer ACTEMRA (tocilizumab) to hospitalized patients in limited clinical situations. Yesudhas D, Srivastava A, Gromiha MM. The interprofessional healthcare team is also responsible for educating the patient on infection control measures. Dependence on medical technology, not related to COVID-19 infection (tracheostomy, PEG tubes, or positive pressure ventilation), Monoclonal antibody therapy is contraindicated for severely symptomatic patients who require hospital admission. 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. In: StatPearls [Internet]. CMS created HCPCS code J0248 for VEKLURY, effective December 23, 2021. COVID-19 Genomics UK (COG-UK) Consortium. When administering monoclonal antibodies, theinterprofessional team must be prepared for adverse events such as transfusion reactions and anaphylaxis. This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. Monoclonal antibodies boost the immune system after you are already sick, speeding up your immune response to prevent COVID-19 from getting worse. These monoclonal antibodies are usually given as an intravenous (IV) infusion at . [16]This receptor is found on the respiratory epithelium, upper esophagus, ileum, myocardium, proximal tubular cells in the kidney, and the urothelium of the bladder. Lenz HJ. In clinical trials, mAb (Casirivimab/Imdevimab) treatment reduced the risk of hospitalization by 50% in patients with mild to moderate COVID-19. ) Clinical development methodology for infusion-related reactions with monoclonal antibodies. If your hospice patients Medicare Advantage plan participates in the Hospice Benefit Component of the Value-Based Insurance Design (VBID) Model, submit claims for administering COVID-19 monoclonal antibody products to the Medicare Advantage Plan. We geographically adjust the rate based on where you furnish the service. Dont bill for USG-purchased products. [27], Analysis by Stokes et al. Access free multiple choice questions on this topic. Doessegger L, Banholzer ML. This rate reflects updated information about the costs involved in furnishing these complex products in a patients home. Inflammation and problems with the immune system can also happen. 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 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). 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. Once symptoms resolve, the infusion may be restarted at a slower rate. These include soreness where the jab was. 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. Governor Ron De Santis touted it as an " early treatment for keeping people out of the hospital and reducing mortality.". Adverse events that have been observed have been injection site reactions with subcutaneous administration and transfusion-related reactions. Talk to your healthcare provider if you experience any of the following in the days after monoclonal antibody treatment: Chills Diarrhea Fatigue Fever Muscle aches and pains Nausea Vomiting Cytokine Release Syndrome Think of them as reinforcements from someone who had more time to build up defenses against COVID-19 which your immune system can benefit from earlier on. [8]On January 26, 2023,the FDA announced that EVUSHELD isnt currently authorized for emergency use in the U.S. Get the most currentlist of billing codes, payment allowances, and effective dates. Monoclonal antibody treatments mimic our immune system's response to SARS-CoV-2 (the infection that causes COVID-19). The interprofessional healthcare team must be familiar with the dosages and methods of administering monoclonal antibodies. Monoclonal antibody therapy reduces deaths and hospitalizations in non-hospitalized patients with risk factors for severe disease progression. 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: The virus that causes COVID-19 (SARS-CoV-2) is constantly changing, and CDC expects new viral variants to continue to emerge. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent in COVID-19, has created a global pandemic and overwhelmed hospital systems globally. bruising of the skin. COVID-19 vaccines protect against the SARS-CoV-2 virus only, so it's still important to keep yourself healthy and well. Hypersensitivity, including infusion-related and . People who had severe illness with COVID-19 might experience organ damage affecting the heart, kidneys, skin and brain. Essentially, monoclonal antibody therapy for viral infection involves generating an antibody molecule type that reacts with the virus. Coronavirus Disease 2019 Case Surveillance - United States, January 22-May 30, 2020. It's important to note that the pill is meant to be taken after you've experienced COVID-19 symptoms. On April 5, 2022, the FDA announced that, 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. Secure .gov websites use HTTPSA The effects also could lead to the development of new conditions, such as diabetes or a heart or nervous . 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. Monoclonal antibodies used for the treatment of COVID-19 target the viral spike protein, which prevents viral entry. 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. The word "monoclonal" refers to the fact that the antibodies created in the laboratory are clones. 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. http://creativecommons.org/licenses/by-nc-nd/4.0/ Serious and unexpected side effects may happen. 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. http://creativecommons.org/licenses/by-nc-nd/4.0/. Blood tests show even after three doses of Pfizer's vaccine, she has no detectable antibodies against Covid-19. Getprovider enrollmentinformation. Therefore, you may not administer bebtelovimab to treat COVID-19 under the EUA until further notice. Monoclonal antibodies, . While individuals of all ages are at risk of contracting COVID-19 and developing severe disease, several risk factors have been identified that place patients at higher risk for morbidity and mortality. Therefore, you may not administersotrovimabto treat COVID-19 under the EUA until further notice. Injection site reactions and infusion-related reactions are the most commonly reported adverse events. The antibodies range in effectiveness depending on type, but some have been shown in to reduce COVID-related hospitalization or death by up to 85%. Bayer V. An Overview of Monoclonal Antibodies. Under the terms of the EUA, tocilizumab may only be infused in the hospital setting, in limited clinical situations. Diaz-Ordaz K, Keogh R, Eggo RM, Funk S, Jit M, Atkins KE, Edmunds WJ. 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. website belongs to an official government organization in the United States. 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). You should also refer to theCDC websiteand information from state and local health authorities regarding reports of viral variants of importance in your region to guide treatment decisions. As with naturally occurring antibodies, monoclonal antibodies stimulate the immune system to act against disease-causing agents. 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). There are now 21 clinics around the state, including two in South Florida in Broward and Miami . HHS/ASPR has purchased supplies of . 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. As more data is released and reviewed, the current recommendations regarding monoclonal antibody therapy may change. soreness. 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. 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. It targets the RBD of the SARS-CoV-2 spike protein. In most cases, your patients yearly Part B deductible and 20% co-insurance apply. Side effects can range from mild to serious and may include: Wheezing or trouble breathing. If the Batch # is D534422, the product was commercially-purchased. By binding to the viral spike protein's receptor-binding domain(RBD), these antibodies competitively inhibit ACE2 receptor binding and prevent viral entry into the cell. Thus far, a single intramuscular injection of the antibodies reduced symptomatic Covid risk by 77% compared with the placebo during the first one to five months of a planned 15 months of follow-up. 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. Identify the indications and contraindications for monoclonal antibody therapy in the management of outpatient COVID-19 infections. Antibodies to SARS-CoV-2, the virus that causes COVID-19, can be detected in the blood of people who have recovered from COVID-19 or people who have been vaccinated against COVID-19. This study showed a high prevalence of transient COVID-19 vaccine-related side-effects after primary and booster doses. For most Medicare Advantage hospice patients, submit claims to Original Medicare. Monoclonal antibodies have been authorized for post-exposure prophylaxis, meaning they are used shortly after someone tests positive in order to prevent progression to severe disease. 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). Then, your dose will be reduced to 300 mg every other week. 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. The side effects of receiving any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the injection site. Abbott is receiving monoclonal antibody treatment after testing positive for COVID-19. 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. 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. 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). Choi JC, Kim WY. They are accessible on an outpatient basis, via a single infusion or four injections. This rate reflects information about the costs involved in furnishing these products in a patients home. Vaccine recipients with preexisting immunity had systemic side effects at higher frequencies than those without preexisting immunity (fatigue, headache, chills, muscle pain, fever, and joint. [2][3][4]At this time, however, there is minimal data that suggests these therapies improve outcomes. Long descriptor: Injection, bamlanivimab-xxxx, 700 mg, Long Descriptor: Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring, Short Descriptor: Bamlanivimab-xxxx infusion, RegeneronsAntibody REGEN-COV (casirivimab and imdevimab)(ZIP), Note: This product isnt currently authorized[1], 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, RegeneronsAntibody REGEN-COV (casirivimab and imdevimab) (ZIP), 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, 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, Regenerons Antibody REGEN-COV (casirivimab and imdevimab) (ZIP), November 21, 2020 TBDNote: 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: Intravenous infusion or subcutaneous injection, casirivimab and imdevimab includes infusion or 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, Short Descriptor: Casirivi and imdevi inj hm, Eli Lilly and CompanysAntibody Bamlanivimab and Etesevimab, (ZIP), 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 Companys 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 beneficiarys home that has been made provider-based to the hospital during the COVID-19 public health emergency, Short Descriptor:
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