Biodesign Institute at Arizona State University Acta Biomed. Plant-made COVID-19 therapies have several advantages over other production platforms. Subscribe to The Optimist to get weekly updates on the latest in global health, gender equality, education, and more. Regenerons two antibodiesare targeted to the spike protein of SARS-CoV-2 the protrusions on the surface of virus that give it a crown-like look and are critical for infecting human cells. \7@~=YU_VT!w#t_E~k4KXF3:@u] /'q?Ix6L\ie0,$ A*UD$$@mTx `VELAr$Y\:/^ Ok3@b$T;WPC=N{2HDBY5$T UlC#h]xRcbYP*vk=jx Y. An official website of the United States government. And what exactly is a monoclonal antibody? endobj Unable to load your collection due to an error, Unable to load your delegates due to an error. They can . 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. Bookshelf Causes behind painful breathing, fluid buildup. By blocking the virus's entry into human cells, reducing viral load and triggering the immune system to fight off the infection, monoclonal antibodies can help reduce the severity of COVID-19. government site. A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. <> For dates of service on or after August 15, only bill Medicare if you use commercially-purchased products. COVID-19 VEKLURY(Remdesivir) in the Outpatient Setting. Over the course of the pandemic, the U.S. Food and Drug Administration (FDA) authorized four monoclonal antibodies to treat COVID-19 and one to help prevent the disease in people who cant get or benefit from vaccines. Thats partly because many people have some level of immunity from vaccination or previous infection, but also because we now have an arsenal of tools to treat the 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). This rate reflects updated information about the costs involved in furnishing these complex products in a patients home. Therefore, you may not administersotrovimabto treat COVID-19 under the EUA until further notice. Monoclonal Antibody Treatments. McCreary EK, Bariola JR, Wadas RJ, Shovel JA, Wisniewski MK, Adam M, Albin D, Minnier T, Schmidhofer M, Meyers R, Marroquin OC, Collins K, Garrard W, Berry LR, Berry S, Crawford AM, McGlothlin A, Linstrum K, Nakayama A, Montgomery SK, Snyder GM, Yealy DM, Angus DC, Kip PL, Seymour CW, Huang DT, Kip KE. If this happens, the virus becomes harmless because it can no longer enter our cells and reproduce. For most Medicare Advantage hospice patients, submit claims to Original Medicare. You might have both United States Government (USG)-purchased and commercial product in your inventory. Official websites use .govA This makes a hospital visit less likely. The ACE2 binding site is highly conserved among different SARS-CoV-2 variants, although mutations in this region can occur and may affect the virus's ability to enter cells and their success at thwarting vaccines or therapeutics designed to target them. Such innovation would provide immediate protection that could last for months. See theEUAfor more information. When they are given to an individual, monoclonal antibodies provide instantaneous protection for weeks to months. Graphic by Jason DreesDownload Full Image. 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. Thats all the more reason to support additional research and have public-private partnerships to improve access to monoclonal antibodies in low- and middle-income countries. All of the monoclonal antibodies we give are injections, mostly intravenous (IV) infusions. Serum antibody therapy is based on antibodies in plasma from donors who beat COVID-19, while monoclonal antibodies are produced in a lab. 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. She says monoclonal antibodies could be a game changer in the fight against malaria, respiratory syncytial virus (RSV), HIV, and other infectious diseases. This site needs JavaScript to work properly. "Monoclonal antibodies mimic your immune system and block the virus that causes COVID-19 from entering your body's cells," explains Dr. David T. Huang, a professor of clinical care medicine . [Deep knowledge, daily. endobj Monoclonal antibodies (mAbs) can be created in the lab by recombinant DNA technology to mimic those antibodies naturally generated by the immune system. Follow all of the Expert Voices issues and debates and become part of the discussion onFacebook andTwitter. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. 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). 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. Malarias devastating impact calls for additional and novel solutionsto addressthis preventable and curable disease. Matching a specific human-made antibody to a particular target has many applications in medicine. Sotrovimab, a recombinant human monoclonal antibody (mAb) against SARS-CoV-2, had US FDA Emergency Use Authorization (EUA) for the treatment of high-risk outpatients with mild-to-moderate COVID-19 treatment. But the antiviral drug has some downsides. In February 2022, the FDA authorized a new monoclonal antibody, bebtelovimab, that was found to be effective against Omicron in small clinical trials. JacquelineKirchner:We can link molecules together, and they become almost like molecular Velcro. These findings are incredibly encouraging, considering the limitations of current tools such as seasonal malaria chemoprevention and an approved vaccine (RTS,S), which have a more complex dosing regimen and lower efficacy. COVID-19; SARS-CoV-2; blood pressure; casirivimab/imdevimab; subcutaneous monoclonal antibodies. Scientists will also need to continue to develop new versions of the treatment to keep up with the viruss evolution. COVID-19 is once again surging throughout the U.S., but deaths from the disease dont seem to be following suit. But it was really critical to use these cells to test how effective their approach really was., Download the NBC News app for full coverage of the coronavirus outbreak. This means the drug goes directly into your blood through a small needle inserted into a vein in your arm. Because the binding domain targeted by the new monoclonal antibody treatment is not under strong selective pressure, it is mutation resistant, compared with ACE2, making it much harder for the virus to outwit the therapy. There may be different recommendations for individual drugs or drug combinations. Eli Lilly hasreceived FDA approval, andRegeneron is still awaiting approval. The Emergency Use Authorization for mAb does not list hypotension as a contraindication for treatment. The FDA recommends this option for patients who cant get vaccinated because theyre allergic to the shots ingredients or are immunocompromised severely enough that they wont mount a sufficient response to the vaccine. Monoclonal antibodies are laboratory-made molecules that can mimic the immune system's ability to fight off pathogens, including SARS-CoV-2 and other viruses. The FDA has authorized additional treatments for emergency use. The treatment that Mr. Trump called a cure for Covid-19 is a cocktail of two monoclonal antibodies manufactured by Regeneron. Monoclonal . When this connection happens, the virus is able to infect cells and multiply inside them. An Update on COVID-19 Treatments: Monoclonal Antibodies, Convalescent Plasma, and Other Promising Developments. This article is republished fromThe Conversationunder a Creative Commons license. For example, if you administer 200mg of tocilizumab in 1 infusion, you should add 200 as the number of units on the claim. In 2019seven of the top 10 best-selling drugs (opens in new tab)were monoclonal antibodies. An experimental monoclonal antibody cocktail made by Regeneron and hailed by President Donald Trump as a cure was tested on cells derived, long ago, from fetal tissue research for which Trumps own administration drastically slashed funding just last year. JacquelineKirchner:I have spent my career working on novel solutions for devastating diseases. Think $2.7 billion toward vaccine manufacturing, which is part of the $65 billion decade-long proposal the Biden administration created to prepare for future pandemics. They are a type of medical treatment. Monoclonal antibodies will be able to complement vaccines by offering rapid protection against infection. Watch for Eli Lilly to release more information about future batch numbers. COVID-19 treatments: What are the options, and are they better than vaccines? The company showed slides with detailed data from 275 infected . If you qualify, a pharmacist will call you and schedule a time for you to receive an infusion. PMC These lab-made therapies are . Although a number of relatively new companies have expressed interest in developing monoclonal antibodies for infectious diseases and have started to make some related investments, some may not be able to muster the resources to carry out that research. Among their formidable weapons is the ability to ceaselessly mutate, developing new variants that the bodys natural or vaccine-induced defenses cannot fight. Noninferiority of Subcutaneous Versus Intravenous Casirivimab/Imdevimab for Outpatient Treatment of SARS-CoV-2 in a Real-World Setting. If you are eligible, you will be contacted by a Nebraska Medicine case manager. These cells date back to the 1970s and were originally taken from kidney cells in donated fetal tissue. Providers may not furnish tocilizumab in the home or residence, including homes or residences that have been made provider-based to the hospital during the COVID-19 PHE. JacquelineKirchner:This is a time of immense opportunity and exciting possibility when it comes to innovation for biologics. We know that once these monoclonal antibodies are available, they will protect children from malaria and RSVnow we need to work hard to make them available as fast as possible. Rodney E. Rohde is a regents professor at Texas State University and chair for the Clinical Laboratory Science (CLS) Program in the College of Health Professions at Texas State University. 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. On December 23, 2022, the. The FDA allows the use of mAbs for adults and children who have mild to moderate COVID-19 symptoms. This might be a lifesaving intervention in people who are unable to mount a strong natural immune response to the virus those over 65 or with existing conditions that make them more vulnerable. CMS geographically adjusts the rate based on where you furnish the service. We are currently offering three types of monoclonal antibodies at our Clarkson Tower infusion center: We have the most of bamlanivimab with estesevimab, and casirivimab with imdevimab, but unfortunately, they are not effective against the omicron COVID-19 variant. Thenew researchhas been selected for the cover of the current issue of Plant Biology Journal. Jacqueline Kirchner: Monoclonal antibodies can be developed quickly and are extremely potent and generally safe. These man-made antibodies can act as the front line fighters. This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. 2023 TIME USA, LLC. Monoclonal antibody treatments are infusions of lab-made proteins that mimic the immune system's ability to fight off COVID. Use of this site constitutes acceptance of our, Digital mAbs are lab-made proteins engineered to act like human antibodies in the immune system, attacking unwanted cells.They offer a treatment option for patients undergoing cancer treatment and other . They are designed to . 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. The FDA authorized Paxlovid for people ages 12 and older who weigh at least 88 pounds. [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. The new therapy could also be added to existing therapies for COVID-19, significantly enhancing their protection. When high-risk patients took the drug within three days of first experiencing symptoms, the treatment reduced the likelihood of hospitalization and death by 89%. Still monoclonal antibodies are going to continue to play a role and are probably going to continue to be updated for the new variants, says Dr. James Cutrell, an infectious disease specialist at UT Southwestern Medical Center. However, if those same antibodies were on a Multabody, they could still neutralize a variant like omicron because the Multabody would be much more potent. 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. Our findings suggest mAb therapy should be administered in an environment where vitals are monitored. Trump received an intravenous infusion of the antibodies from the drug company last week as part of his treatment for the illness. Health care providers can bill on a single claim for administering COVID-19 monoclonal antibody products, or submit claims on a roster bill. This stops the virus from invading human cells. view more. They are all in clinical trials and are not yet fully FDA-approved. It would surprise people if they ever did find out exactly what goes into the production and testing of some of the treatments, Kreigstein said. 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 Nevertheless, the virus can sometimes manage to outmaneuver such therapies. Benefits of antiviral therapy. Clipboard, Search History, and several other advanced features are temporarily unavailable. At the foundation, were also interested in approaches that engineer better versions of these kinds of molecules. 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. If the Batch # is D534422, the product was commercially-purchased. The treatment can also shorten how long COVID-19 symptoms last. The study also underscores the potential of plant-based monoclonal antibody expression platforms in therapeutic development against the ever-evolving SARS-CoV-2 pandemic. Its known to interact with many medications, including certain anti-hypertensives, cardiovascular drugs, and psychiatric drugs. 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. Monoclonal antibodies were once the star of COVID-19 outpatient treatments. Its also possible that the advice could change, as reports emerge of rebound infectionscompleting a course of the drug, testing negative, and then testing positive shortly afterin patients who take Paxlovid. Even when a vaccine for COVID-19 becomes available, I see a role for monoclonal antibody therapy in getting the pandemic under control. 8600 Rockville Pike 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. The .gov means its official. How hopeful can we be that monoclonal antibodies will make a difference for diseases like malaria in the near future? These therapeutic products are available for the treatment of mild to moderate COVID-19 in adult and pediatric patients (>12 years old and >40 kg) who are at high risk for progressing to . Treatment must be started within days after you first develop symptoms to be effective. When the immune system identifies a pathogen like SARS-CoV-2, it begins to churn out antibodies: proteins that recognize and bind to specific proteins found on the virus. 1. Research seems to show that some mAbs, when used correctly, may help some people with COVID-19. This provides a therapeutic candidate for fighting against new mutations of the COVID-19 virus, Chen says. 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. One of Regenerons two antibodies is a replica, or clone, of an antibody harvested from a person who recovered from COVID-19. They would offer almost instant neutralization for viral infections, and likely provide a much less problematic recovery for those with symptoms. Theres no cost sharing for people with Medicare for COVID-19 monoclonal antibody products or their administration. Wegeographically adjustthe rate based on where you furnish the service. 4 0 obj The average drop in SBP was 9.2 mmHg for those patients. As a result, Medicare hasnt created a separate HCPCS code for billing for the higher Medicare payment amount for administering tocilizumab in the home. Hundreds of thousands of people infected with Covid-19 have been treated with antibodies since one was first authorized in the Fall of 2020. But monoclonal antibodies offer promise well beyond COVID-19. CMS identified specific code(s) for each COVID-19 monoclonal antibody product and specific administration code(s) for Medicare payment: Eli Lilly and CompanysAntibody Bamlanivimab (LY-CoV555). 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. Still, he emphasizes, The most important thing is vaccination and boosters, and taking reasonable precautions, he says. 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. What Is the Regeneron Antibody Cocktail? 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). 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. 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. 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). Continue to bill for administering either type of product. Pharmacists: 0.50 contact hour (0.05 CEUs) 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 M0241, M0244, M0246, M0248, or M0223. Secure .gov websites use HTTPSA Key messages - We do not know whether antibodies (the body's natural defence against disease) made in a laboratory and all the same as one another (monoclonal) and designed to target COVID-19, are an effective treatment for COVID-19 because we assessed only six studies exploring different treatments in different types of patients. Now there are four monoclonal antibody treatments that . 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. To find out if these treatments are right for you, you can start by checking the online COVID-19 information sites at the CDC, FDA, or NIH. NY 10036. In such partnerships, nonprofit organizations like the foundation can identify and fund research efforts that private companies may not know are needed, or may not be able to take on by themselves due to the risk of failure, costs, and other constraints. As the omicron variant pushes COVID-19 case counts to new highs, we've received audience questions about monoclonal antibodies, which are used to prevent and treat infection from the coronavirus. JacquelineKirchner:Multabodiesmulti-specific, multi-affinity antibodieswere invented by our grantee Jean-Philippe Julien at SickKids in Toronto. Therefore, the other option for the treatment of the patient with COVID-19 was the use of monoclonal antibodies. Despite the inconvenience, monoclonal antibodies went into widespread use for treating Covid. The ACE2 receptor is expressed in various tissues throughout the body, including the lungs, heart, kidneys and intestines, which may contribute to the diverse symptoms and complications associated with COVID-19. More Information about Payment for Infusion & IV Injection at Home. sharing sensitive information, make sure youre on a federal We geographically adjust the rate based on where you furnish the service. Douglas Lake, a researcher in theVirginia G. Piper Biodesign Center for Personalized Diagnostics, the Biodesign Center for Immunotherapy, Vaccines and Virotherapy and associate professor with ASUs School of Life Sciences, also collaborated on the early phase of the project. Centers for Medicare & Medicaid Services: Monoclonal Antibody COVID-19 Infusion., European Medicines Agency: EMA reviewing data on monoclonal antibody use for COVID-19., FDA: Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals, Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant, Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab., Journal of the American Medical Association: Monoclonal Antibodies for COVID-19., NIH COVID-19 Treatment Guidelines: Anti-SARS-CoV-2 Monoclonal Antibodies.. Since they offer immediate protection, the implications to treat or provide protection to high-risk populations is immense. Your browser appears to be unsupported. 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. This includes the targeted treatment of diseases like cancer, rheumatoid arthritis, and COVID-19. But now a vaccinemay soon be available. [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) isnt currently authorized in any U.S region. Antibodies that bind to the spike protein are called neutralizing antibodies, because theyre able to prevent SARS-CoV-2 from entering cells and replicating, thus neutralizing the infection. [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. Please install a current version of Chrome, Firefox, Edge, or Safari for a better experience. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. The novel coronavirus SARS CoV-2 is responsible for the COVID-19 global pandemic. or Future US, Inc. Full 7th Floor, 130 West 42nd Street, Early in the pandemic, three monoclonal antibody treatmentsbamlanivimab, casirivimab and imdevimab (which are administered together), and sotrovimabwere shown to reduce the risk of hospitalization and death from COVID-19. Effectiveness of Casirivimab-Imdevimab and Sotrovimab During a SARS-CoV-2 Delta Variant Surge: A Cohort Study and Randomized Comparative Effectiveness Trial. Review the Antiviral Resistance information in the Fact Sheet for each monoclonal antibody therapy authorized under anemergency use authorization (EUA)for details regarding specific variants and resistance. Monoclonal Antibodies for COVID-19: Pharmacist Focus on the Rapidly Evolving Treatment Landscape . T#/Tz:Wn>U[L.|}?^8 t{2940R:r_Ooz3NWt\iE*h**MSf^)>V~HT$f*-JN=G)Uo~d C8~e.( :F:Jc/'/z&4Q'aJ_*?\@Z`A OhT{65QAHGq(GOv To receive a monoclonal antibody infusion, you must have tested positive for COVID-19 and meet at least one of the following requirements: Age 65 . Monoclonal antibodies are particularly promising in therapy because they can neutralize the SARS-CoV-2 virus, which causes COVID-19, and block its ability to infect a cell. doi: 10.1001/jamanetworkopen.2022.6920. 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