http://creativecommons.org/licenses/by-nc-nd/4.0/ For details about specific variants and monoclonal antibody resistance, review the Antiviral Resistance information in each of the Fact Sheets listed above. TGC has proven to be of value in treatment of multidrug-resistant infections, but therapy can be complicated by multiple dangerous side effects, including direct drug toxicity. These antibodies are typically. Healthcare providers should also educate the patients on the potential benefits of monoclonal antibody therapy for the treatment of COVID-19. Gao Y, Huang X, Zhu Y, Lv Z. The authorized dose for REGEN-COV for. 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 . Getprovider enrollmentinformation. Brobst B, Borger J. [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. Monoclonal antibody treatments are infusions of lab-made proteins that mimic the immune system's ability to fight off COVID. 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antibodies in the treatment of COVID-19 appears promising, at this time, thebulk ofthis data is preliminary and unpublished and has not been peer-reviewed. Official websites use .govA Medicare will establish codes and rates for administering new products as the FDA approves or authorizes each product. Get the most current payment allowances and effective dates for these products. 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. 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. ), which permits others to distribute the work, provided that the article is not altered or used commercially. It was developed in 2013 in plasma taken from a patient who had recovered from the 2003 Severe Acute Respiratory Syndrome virus (SARS). 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. Infusion-related reactions are potential adverse reactions when administering monoclonal antibodies and are common with drugs such as rituximab. Therefore, you may not administer bebtelovimab to treat COVID-19 under the EUA until further notice. Monoclonal antibodies are free to patients and there have been almost no side effects. Heres how you know. Adults and children 12 years of age and olderAt first, 600 milligrams (mg) (two 300 mg injections) injected under the skin at different injection sites. Pregnant people. As a result, Medicare hasnt created a separate HCPCS code for billing for the higher Medicare payment amount for administering tocilizumab in the home. 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. As demonstrated above, monoclonal antibody therapy used in the treatment of outpatient COVID-19 in patients at risk for developing severe disease has the potential to decrease hospitalizations and mortality. swelling. [23][24]Infusion-related reactions are characterized by flushing, fever/chills, back or abdominal pain, nausea/vomiting, pruritus, or skin rashes. Some people report mild side effects, like headache or stomach upset/nausea. Typical side effects include pain at the injection site, fever, fatigue, headache, muscle pain, chills and diarrhoea. 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. In: StatPearls [Internet]. Essentially, monoclonal antibody therapy for viral infection involves generating an antibody molecule type that reacts with the virus. At high risk of dying from the virus, Barron remains a virtual prisoner in her . 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. In most cases, your patients yearly Part B deductible and 20% co-insurance apply. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Monoclonal Antibodies to Treat Mild-to-Moderate COVID-19. See theEUAfor more information. The most commonly reported side effect was diarrhea (1%).[22]. Monoclonal antibodies prevent progression to severe disease, are not equally effective across variants, and are associated with minimal and self-limited reactions. Healthcare providers must also educate the patient on symptoms that mark progression to severe disease and prompt the patient to return for reevaluation. Immunosuppression either via disease or treatment, Cardiovascular disease (including hypertension, coronary artery disease, heart failure, congenital heart defects), Chronic lung disease (COPD, asthma, cystic fibrosis, interstitial lung disease, pulmonary hypertension), Neurodevelopmental disorders or other conditions that increase medical complexity. [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. Healthcare providers should also be aware of the resistance of certain variants of the SARS-CoV-2 virus. 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. Few cases of anaphylaxis have been reported. ( COVID-19 Genomics UK (COG-UK) Consortium. Adverse Reactions [5][6], Monoclonal antibodies have been identified as a potential therapy to prevent disease progression in patients at risk for severe disease. 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: The antibodies . A benefit of casirivimab and imdevimab treatment has not been shown in people hospitalized due to COVID19. For many providers and suppliers, CMS also geographically adjusts this ratebased on where youfurnishthe service. Mitj O, Corbacho-Monn M, Ubals M, Alemany A, Suer C, Teb C, Tobias A, Peafiel J, Ballana E, Prez CA, Admella P, Riera-Mart N, Laporte P, Mitj J, Clua M, Bertran L, Sarquella M, Gaviln S, Ara J, Argimon JM, Cuatrecasas G, Caadas P, Elizalde-Torrent A, Fabregat R, Farr M, Forcada A, Flores-Mateo G, Lpez C, Muntada E, Nadal N, Narejos S, Nieto A, Prat N, Puig J, Quiones C, Ramrez-Viaplana F, Reyes-Uruea J, Riveira-Muoz E, Ruiz L, Sanz S, Sents A, Sierra A, Velasco C, Vivanco-Hidalgo RM, Zamora J, Casabona J, Vall-Mayans M, Gonzlez-Beiras C, Clotet B., BCN-PEP-CoV2 Research Group. Although the Food and Drug Administration gave these treatments like Regeneron emergency use authorization in 2020, the criteria for who is eligible to receive them has expanded. It's important to note that the pill is meant to be taken after you've experienced COVID-19 symptoms. 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. The emergency use authorization(EUA) for sotrovimab is for use in non-hospitalized patients 12 years or older, weighing more than 40 kg, with mildor moderate symptoms, who have one or more risk factors for progression to severe disease. 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 They are exact copies of one . 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. [1]Since its initial identification,SARS-CoV-2 has spread worldwide and incited a global pandemic. In response to the COVID-19 PHE, the governmentinitially purchased the COVID-19 monoclonal antibody products and made them available for free. Estimated transmissibility and impact of SARS-CoV-2 lineage B.1.1.7 in England. These are not all the possible side effects. Side effects can range from mild to serious and may include: Wheezing or trouble breathing. 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. Several potential outpatient therapies have been suggested as a way to treat symptoms and prevent progression to severe disease, including colchicine,hydroxychloroquine,inhaled corticosteroids,ivermectin,and fluvoxamine. CMS geographically adjusts the rate based on where you furnish the service. No dosing adjustments are recommended for patients based on renal impairment, pregnancy, or lactation status. Previously authorized monoclonal antibodies had their authorizations revoked in January 2022 with the emergence of the Omicron variant. Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial. 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. 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. Find More Information about COVID-19 COVID-19 Vaccines Exposed to COVID-19 People With a Weakened Immune System They should review the information found in section 15 on the fact sheets issued for each of the monoclonal antibodies. But Regeneron Pharmaceuticals, maker of the only authorized, free monoclonal . This likely will bring more attention to this treatment, which has proven to cut . 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). Side effects may occur from mAbs treatment including rash, diarrhea, nausea, dizziness and pruritis (itchy skin). 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. Learn more about treatment guidelines and recommendations for using monoclonal antibody therapies. Millions of vaccinated people have experienced side . There may not be data from patients, but lab studies strongly suggest the treatments will not help omicron-infected people. The highly contagious nature of the virus and its high potential for morbidity and mortality has overwhelmed hospital systems worldwide with hospitalizations and deaths. [25][26]One percentof the patients who received sotrovimab had infusion-related reactions. See the Federal Register announcement for more information about the revoked EUA and NDA approval. Get the most currentlist of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products. N.Y.C.'s Mandate: New York City will end its aggressive but contentious vaccine mandate for municipal workers, Mayor Eric Adams announced, signaling a key moment in the city's long battle . For most Medicare Advantage hospice patients, submit claims to Original Medicare. Inflammation and problems with the immune system can also happen. Coronavirus Disease 2019 Case Surveillance - United States, January 22-May 30, 2020. This study showed a high prevalence of transient COVID-19 vaccine-related side-effects after primary and booster doses. HHS/ASPR has purchased supplies of . The trial had a population of 583 non-hospitalized adults with risk factors for severe disease or age above 55 years randomly assigned into groups either receiving 500 mg of sotrovimab or placebo. 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. Benefits And Risks Of Administering Monoclonal Antibody Therapy For Coronavirus (COVID-19) [Updated 2022 Apr 28]. On Jan. 24, the FDA announced it was no longer authorizing two COVID-19. of confirmed cases reported to the CDC found that older individuals (65 years old) with underlying comorbidities have a much higher risk of hospitalizations than those without (45.4% vs. 7.6%). We geographically adjust the rate based on where you furnish the service. Typically, monoclonal antibodies are given to higher-risk patients who have mild to moderate symptoms from a COVID-19 infection. 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. After binding the ACE2 receptor, the virus can gain entry to the cell, and viral replication can occur. An EUA for sotrovimab for treatment of COVID-19. Governor Ron De Santis touted it as an " early treatment for keeping people out of the hospital and reducing mortality.". 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). Monoclonal antibodies used for the treatment of COVID-19 target the viral spike protein, which prevents viral entry. 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 All adverse events related to monoclonal antibody treatment must be reported according to the instructions found in the fact sheets released by the FDA. Although the Food and Drug Administration gave these treatments . 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. Per the CDC, there have been over 48 million cases in the United States alone, and greater than 777,000 deaths reported due to Covid-19 infection. This activity outlines the indications, actions, contraindications, and adverse events for monoclonal antibody therapy as a valuable treatment for outpatient COVID-19 infections. For more information about billing and payment for VEKLURY in the outpatient setting: Monoclonal Antibodies for Pre-Exposure Prophylaxis of COVID-19. [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. This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. For dates of service on or after August 15, only bill Medicare if you use commercially-purchased products. 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. Monoclonal antibodies, however, are produced by a single B-lymphocyte clone and are highly specific for their target antigen. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. Nonetheless, monoclonal antibodies appear to be a promising option in the treatment of COVID-19 and have the potential to prevent hospitalizations and mortality. [12]The full results of this study were published in October 2021. On January 26, 2023,the FDA announced that EVUSHELD isntcurrently authorized for emergency use in the U.S. Prevention and early treatment for eligible patients can help improve patient outcomes, reduce stress on healthcare facilities, and even save lives. 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). 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. 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. More Information about COVID-19 Monoclonal Antibody Products. https:// Patients must be observed for at least one hour after receiving a monoclonal antibody to ensure patient safety. [21], The major benefits derived from the monoclonal antibody therapies appear to be a reduction in viral load, hospitalizations, and death. There are several variants of concern that have been identified, such as the Alpha variant (B1.1.7 lineage, UK origin), Beta variant (B.1351 lineage, South African origin), Gamma variant (P.1/B.1.1.28.1 lineage, Brazilian origin), Delta variant (B1.617.2 lineage, Indian origin). 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. Monoclonal antibodies are lab-made proteins that mimic the immune system's ability to fight off viruses and other harmful pathogens, per the FDA. Administration ofSotrovimab should occur within 10 days of symptom onset. Patients of older age with comorbidities such as cardiovascular disease, obesity, diabetes, chronic kidney disease, and chronic lung disease are at much higher risk of developing severe symptoms and requiring hospitalizations than younger healthy individuals. 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, in a patients home or residence, is approximately $250.50. As a result, CMS issued a new product code for REGEN-COV (Q0244) and updated the descriptors for the existing administration codes (M0243/M0244). The pharmacy staff should be aware of the proper storage and handling of the medications. pain. [27], Analysis by Stokes et al. The federal government isnt purchasing VEKLURY. 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. Health care providers can bill on a single claim for administering COVID-19 monoclonal antibody products, or submit claims on a roster bill. As with naturally occurring antibodies, monoclonal antibodies stimulate the immune system to act against disease-causing agents. Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Hebner CM, Sager J, Mogalian E, Tipple C, Peppercorn A, Alexander E, Pang PS, Free A, Brinson C, Aldinger M, Shapiro AE., COMET-ICE Investigators. 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 The new rate reflects updated information about the costs involved in administering these types of monoclonal antibody products for different types of providers and suppliers and the resources necessary to ensure providers administer the products safely and appropriately. For many providers and suppliers, we also geographically adjustthis ratebased on where youfurnishthe service. CMS geographically adjusts the rate based on where you furnish the service. Shepard HM, Phillips GL, D Thanos C, Feldmann M. Developments in therapy with monoclonal antibodies and related proteins. These antibodies were identified by analyzing convalescent plasma obtained from patients infected with COVID-19. 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. An EUA for bamlanivimab and etesevimab for COVID-19. This requires equipment and medications used for the immediate treatment of allergic reactions including, antihistamines, antiemetics, epinephrine, blood pressure monitoring, and stethoscopes. 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. Most people experience no side effects from monoclonal antibodies for COVID-19. On December 23, 2022, the. 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. 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).