Medical Policy: 02.01.01
Original Effective Date: April 1995
Reviewed: February 2017
Revised: February 2017
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Allergic or hypersensitivity disorders can manifest themselves as generalized systemic reactions as well as localized reactions in any organ system of the body. Numerous agents, e.g., pollen, mold, dust mites, animal dander, insect stings, foods or drugs, may precipitate allergic or hypersensitive reactions. For details on coverage of allergy testing services, see Policy 02.01.02, Allergy Testing. For information on oral immunotherapy tablets see drug policy Oral Immunotherapy Policy.
The management of an allergic patient should include a comprehensive history, physical examination and should include confirming the cause of allergies. Once the agent is identified, treatment is provided by avoidance, medication or immunotherapy.
Immunotherapy involves regular injections of offending allergens which are not readily avoidable. The treatment is provided over a period of months to years, with a goal of reducing symptoms. Allergy shots work like a vaccine. Your body responds to injected amounts of a particular allergen, given in gradually increasing doses, by developing immunity or tolerance to the allergen. There are two phases:
- Build-up phase. This involves receiving injections with increasing amounts of the allergens about one to two times per week. The length of this phase depends upon how often the injections are received, but generally ranges from three to six months.
- Maintenance phase. This begins once the effective dose is reached. The effective maintenance dose depends on your level of allergen sensitivity and your response to the build-up phase. During the maintenance phase, there will be longer periods of time between treatments, ranging from two to four weeks.
Rush immunotherapy would be provided over only a few visits. The exact mechanism of action is not known but may involve an increase in allergen specific IgG antibodies, a decrease in IgE synthesis and alteration in T-lymphocyte activity.
Allergen-specific immunotherapy involves administering well-characterized allergen extracts, the potencies of which are measured and compared with a reference standard. An initial induction or build-up phase progressively increases the allergen dose; this is followed by multiple years of maintenance injections at the highest dose. Allergen-specific immunotherapy has been used to treat a variety of conditions including insect allergy, allergic rhinitis, and asthma. Subcutaneous injection of allergen-specific immunotherapy is the standard approach.
Guidelines Task Force: American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy Asthma & Immunology.
Immunotherapy is effective for the treatment of allergic rhinitis, allergic conjunctivitis, allergic asthma, and stinging insect hypersensitivity. Clinical trials do not support the use of subcutaneous immunotherapy for food hypersensitivity. Oral immunotherapy and SLIT (sublingual immunotherapy) for food hypersensitivity/food allergies are considered investigational. Immunotherapy is not currently approved by the Food and Drug Administration for use to treat food allergy.
Allergy immunotherapy is only recommended and considered medically necessary for:
- allergic rhinitis not due to food allergy
- allergic conjunctivitis, not due to food allergy
- allergic asthma, not due to food allergy
- stinging insect hypersensitivity (current state).
Allergy immunotherapy is considered investigational for all other indications, including but not limited to:
- Atopic dermatitis
- Chronic urticaria
- Food allergies
- Intrinsic (non-allergic) asthma
- Migraine headaches
- Poison ivy/poison oak
- Treatment of behavior health disorders
- Treatments for electromagnetic sensitivity syndrome/disorder
- Non-allergic rhinitis
Allergy therapy with Rapid Desensitization (also known as Rush or Cluster Desensitization process), in which the person would get an increased dosage over only a few days instead of over months or years, may be considered medically necessary only for patients with the following:
- Insect sting hypersensitivity
- IgE antibodies to a particular drug that is essential for a condition that cannot be treated effectively with alternative medications
Rapid Desensitization for any other condition, including but not limited to food allergies and inhalant allergies is considered investigational.
Sublingual drop immunotherapy is considered investigational for all indications.
Allergen-proof supplies, such as mattresses, pillows, and casings, etc., are considered personal convenience items and are not covered.
Per unit reimbursement for allergy immunotherapy is based on the number of dosages prepared and intended for administration. When billing, providers should report the number of units representing the number of 1cc doses being prepared. A maximum of 10 doses per vial is allowed. Allergy immunotherapy is limited to 180 units for the first year of therapy during escalation, and 120 units for yearly maintenance therapy thereafter.
There would not be a medical necessity to receive allergy immunotherapy through injections for grass allergies if oral immunotherapy tablets are being utilized.
According to guidelines from the American Academy of Asthma, Allergy and Immunotherapy: allergen immunotherapy should be administered in a medical facility with trained staff and medical equipment capable of recognizing and treating anaphylaxis. Under rare circumstances, when the benefit of allergen immunotherapy clearly outweighs the risk of withholding immunotherapy (eg, patients with a history of venom-induced anaphylaxis living in a remote region), at-home administration of allergen immunotherapy can be considered on an individual basis.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 95115 Professional services for allergen immunotherapy not including provision of allergenic extracts; single injection
- 95117 Professional services for allergen immunotherapy not including provision of allergenic extracts; 2 or more injections
- 95144 Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy, single dose vial(s) (specify number of vials)
- 95165 Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses)
- 95180 Rapid desensitization procedure, each hour (eg, insulin, penicillin, equine serum)
- 95199 Unlisted allergy/clinical immunologic service or procedure ( e.g., sublingual immunotherapy)
- Munoz-Lopez F. Editorial; New administration route in immunotherapy. Allergologia et Immunopathologia 2000; 28(6):295-297.
- Lockey RR, Bousquet J, Malling HJ. WHO position paper on oral (Sublingual) immunotherapy. Annals of Allergy, Asthma and Immunology 1999; vol. 8:423-424.
- Seidenfeld, J, et al. Sublingual Immunotherapy for Adults. TEC Assessment Program Vol. 18, No. 4 June 2003
- American Academy of Allergy, Asthma and Immunology. American College of Allergy, Asthma and Immunology. Allergen immunotherapy: a practice parameter. Ann Allergy Asthma Immunol. 2003 Jan; 90(1 Suppl 1): 1-40
- Barrett S, Index of Questionable Treatments Nambudripad's Allergy Elimination Technique (NAET); Accessed on the web 12/20/05.
- Cox L; Linnemann D, et al. Sublingual immunotherapy: a comprehensive review. J Allergy Clin Immunol 2006 May;117(5):1021-35.
- Varshney P, Jones SM, Scurlock AM et al. A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response. J Allergy CLin Immunol. 2011 Mar; 127(3):654-60.
- Jones SM, Pons L, Roberts JL et al. Clinical efficacy and immune regulation with peanut oral immunotherapy. J Allergy Clin Immunol. 2009 Aug; 124(2):292-300, 300.el-97. Epub 2009 Jul 3.
- Shripak JM, Nash SD, Rowley H et al. A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy. J Allergy Clin Immunol. 2008 Dec; 122(6):1154-60. Epub 2008 Oct 25.
- Zapatero L, Alonso E, Fuentes V et al. Oral desensitization in children with cow's milk allergy. J Investig Allergol Clin Immunol. 2008; 18(5):389-96.
- De Bot CM, Moed H, Berger MY et al. Sublingual immunotherapy in children with allergic rhinitis: quality of systematic reviews. Pediatr Allergy Immunol 2011; 22(6):548-58.
- Calderon MA, Penagos M, Sheikh A et al. Sublingual immunotherapy for treating allergic conjunctivitis. Cochrane Database Syst Rev 2011; (7):CD007685.
- Radulovic S, Wilson D, Calderon M et al. Systematic reviews of sublingual immunotherapy (SLIT). Allergy 2011; 66(6):740-52.
- Eifan AO, Akkoc T, Yildiz A et al. Clinical efficacy and immunological mechanisms of sublingual and subcutaneous immunotherapy in asthmatic/rhinitis children sensitized to house dust mite: an open randomized controlled trial. Clin Exp Allergy 2010; 40(6):922-32.
- Sieber J, Shah-Hosseini K, Mosges R. Specific immunotherapy for allergic rhinitis to grass and tree pollens in daily medical practice-symptom load with sublingual immunotherapy compared to subcutaneous immunotherapy. Ann Med 2011; 43(6):418-24.
- Burks AW, Calderon MA, Casale T, Cox L, Demoly P, Jutel M, 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 2013;131:1288-96.
- MK-3641 (SCH 0693413): Ragweed Allergy Immunotherapy tablet page 102 fda advisory committee meeting background package. January 28, 2014. p1-105.
- Stallergenes S.A. Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract) tablet for sublingual use package insert, April 2014. FDA. Briefing document: Grastek, Allergenic Products Advisory Committee (APAC) meeting December 12, 2013.
- Lin SY, Erekosima N, Kim JM et al. Sublingual immunotherapy for the treatment of allergic rhinoconjunctivitis and asthma: a systematic review. JAMA : the journal of the American Medical Association 2013; 309(12):1278-88.
- Lin SY, Erekosima N, Suarez-Cuervo C et al. Allergen-Specific Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and/or Asthma: Comparative Effectiveness Review No. 111. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-2007-10061-I.) AHRQ Publication No. 13-EHC061-EF. 2013.
- Stallergenes S.A. Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract) tablet for sublingual use package insert, April 2014.
- Merck & Co., Inc. Grastek® (Timothy grass pollen allergen extract) tablet for sublingual use prescribing information, April 2014.
- American Academy of allergy Asthma and Immunology, CMS and Medically Unlikely Units.
- February 2017 - Annual Review, Policy Revised
- April 2016 - Annual Review, Policy Revised
- January 2016 - Interim Review, PolicyRevised
- May 2015 - Annual Review, PolicyRevised
- May 2014 - Annual Review, PolicyRevised
- July 2013 - Annual Review, PolicyRevised
- September 2012 - Annual Review, PolicyRevised
- September 2011 - Annual Review, PolicyRevised
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.