Proposed LCD - Allergen Immunotherapy (DL36240)

Home administration of allergen immunotherapy should only be considered in rare and exceptional cases when the benefits of immunotherapy clearly outweigh the risks. Frequent or routine home immunotherapy is not considered appropriate under any circumstances. If this method is utilized, informed consent should be attained from the patient and the individual administering the injection must be trained and equipped to recognize and manage immunotherapy reactions, particularly anaphylaxis.1Provider QualificationsServices will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationPlease refer to the related Local Coverage Article: Billing and Coding: Allergen Immunotherapy, A56538, for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationN/ABibliographyThis bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.Cox L, Nelson H, Lockey R, Calabria C, et al. Allergen immunotherapy: a practice parameter third update.J Allergy Clin Immunol. January 2011;127(1 Suppl):S1-55. doi:10.1016/j.jaci.2010.09.034.Golden DB, Demain J, Freeman T, et al. Stinging insect hypersensitivity: A practice parameter update 2016.Ann Allergy Asthma Immunol. 2017;118(1):28-54. doi:10.1016/j.anai.2016.10.031.Lin SY, Azar A, Suarez-Cuervo C, et al. The Role of Immunotherapy in the Treatment of Asthma. Comparative Effectiveness Review No. 196 (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No.290-2015-00006-I). AHRQ Publication No. 17(18)-EHC029-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2018. doi:10.23970/AHRQEPCCER196.Lin SY, Erekosima N, Suarez-Cuervo C, et al. Allergen-Specific Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and/or Asthma: Comparative Effectiveness Review. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Mar. Report No.: 13-EHC061-EF. https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/asthma-immunotherapy-2010_research-protocol.pdf. Accessed August 11, 2020.Brozek JL, Bousquet J, Baena-Cagnani CE, et al. Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision.J Allergy Clin Immunol. 2010;126(3):466-76. doi:10.1016/j.jaci.2010.06.047.Burks AW, Calderon MA, Casale T, et al. Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus report.J Allergy Clin Immunol. May 2013;131(5):1288-1296. doi:10.1016/j.jaci.2013.01.049.Caldern MA, Alves B, Jacobson M, Hurwitz B, Sheikh A, Durham S. Allergen injection immunotherapy for seasonal allergic rhinitis.Cochrane Database of Syst Rev.January 2007;(1). Art. No.CD001936. doi:10.1002/14651858.CD001936.pub2.Caldern MA, Casale TB, Togias A, Bousquet J, Durham SR, Demoly P. Allergen-specific immunotherapy for respiratory allergies: from meta-analysis to registration and beyond.J Allergy Clin Immunol. 2011;127(1):30-38. doi:10.1016/j.jaci.2010.08.024.Moote W, Kim H, Ellis AK. Allergen-specific immunotherapy.Allergy Asthma Clin Immunol. 2018;14(Suppl 2):53. doi:10.1186/s13223-018-0282-5.Bae JM, Choi YY, Park CO, Chung KY, Lee KH. Efficacy of allergen-specific immunotherapy for atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials.J Allergy Clin Immunol. 2013;132(1):110-117. doi:10.1016/j.jaci.2013.02.044.Lee J, Park CO, Lee KH. Specific immunotherapy in atopic dermatitis.Allergy Asthma Immunol Res. 2015;7(3):221-229. doi:10.4168/aair.2015.7.3.221.Bernstein JA, Lang DM, Khan DA, et al. The diagnosis and management of acute and chronic urticaria: 2014 update.J Allergy Clin Immunol. 2014;133(5):1270-1277. doi:10.1016/j.jaci.2014.02.036.Sampson HA, Aceves S, Bock SA, et al. Joint Task Force on Practice Parameters, Food allergy: a practice parameter update-2014.J Allergy Clin Immunol. 2014;134(5):1016-1025. doi:10.1016/j.jaci.2014.05.013.Boyce JA, Assa'ad A, Burks AW, et al. Guidelines for the diagnosis and management of food allergy in the United States: summary of the NIAID-sponsored expert panel report.J Am Acad Dermatol. 2011;64(1):175-192. doi:10.1016/j.jaad.2010.11.020.Mortuaire G, Michel J, Papon JF, et al. Specific immunotherapy in allergic rhinitis.Eur Ann Otorhinolaryngol Head Neck Dis. 2017;134(4):253-258. doi:10.1016/j.anorl.2017.06.005.Nelson HS. To mix or not to mix in allergy immunotherapy vaccines.Curr Opin Allergy Clin Immunol. 2021;21(6):583-589. doi:10.1097/ACI.0000000000000784.Nelson HS. Multiallergen immunotherapy for allergic rhinitis and asthma.J Allergy Clin Immunol. 2009;123(4):763-769. doi:10.1016/j.jaci.2008.12.013.Wise SK, Lin SY, Toskala E, et al. International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis.Int Forum Allergy Rhinol. 2018;8(2):108-352. doi:10.1002/alr.22073.Wood RA, Togias A, Wildfire J, et al. Development of cockroach immunotherapy by the Inner-City Asthma Consortium.J Allergy Clin Immunol. 2014;133(3):846-52.e6. doi:10.1016/j.jaci.2013.08.047.Seidman MD, Gurgel RK, Lin SY, et al. Clinical practice guideline: Allergic rhinitis.Otolaryngol Head Neck Surg. 2015;152(1 Suppl):S1-S43. doi:10.1177/0194599814561600.