Medical Policy: 02.01.02
Original Effective Date: November 2003
Reviewed: April 2016
Revised: April 2016
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 treatment of allergies, see Policy 02.01.01, Allergy Immunotherapy.
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. Skin testing would be the first line of testing for the majority of patients. In vitro testing would be appropriate necessary for those with the inability to stop specific medications and those that have had severe allergic responses to medicine, food, inhalants, and insectsand insects. It would be inappropriate to use in vitro testing for the majority of patients as the first line of testing.
Allergy is a hypersensitive reaction that is usually manifested in the clinical form of allergic asthma, hay fever or eczema developing within minutes to a few hours after exposure to an antigen. The most common types of allergies are rhinitis, asthma, food allergy, insect sting allergy, drug allergy and contact dermatitis. Allergy testing is focused on determining what allergens cause a particular reaction and the degree of the reaction and provides justification for recommendations of specific avoidance measures in the home or work environment or the institution of particular medicines or immunotherapy. There are virtually no age limitations for performance of skin tests. However, skin test reactivity may be diminished in infants and the elderly. Types of allergy testing include in vivo, in vitro, provocation testing, and controversial allergy tests. The umbrella term ‘food hypersensitivity or food sensitivities’ can be used to describe any ‘adverse reaction to food’. The term ‘food allergy’ refers to the subgroup of food-triggered reactions in which immunologic mechanisms have been implicated, whether IgE- mediated, non-IgE-mediated, or involving a combination of IgE- and non-IgE-mediated etiologies. All other reactions to food that were in the past sometimes referred to as ‘food intolerance’ or ‘food sensitivities’ constitute non-allergic food hypersensitivity reactions and are not considered allergies.
Allergy tests detect the presence of IgE antibodies to a particular allergen, or something that causes an allergic reaction. A positive test suggests allergic sensitization to a specific allergen. There are several in-vitro tests available to diagnose allergies, however, the National Medical and Research Center believes that standard intradermal or epicutaneous skin tests in correlation with a thorough medical history and physical examination best serves the paitent. A positive skin test alone does not diagnose an allergy; it must correlate with symptoms experienced when the patient has an allergen exposure.
Guidelines and Society Recommendations
The American Board of Internal Medicine’s (ABIM) Foundation Choosing Wisely® Initiative (2014): The Choosing Wisely initiative includes the following recommendations from the American Academy of Asthma, Allergy, and Immunology regarding allergy testing:
Don’t perform unproven diagnostic tests, such as immunoglobulin G (IgG) testing or an indiscriminate battery of immunoglobulin E (IgE) tests, in the evaluation of allergy
Don’t routinely do diagnostic testing in patients with chronic urticaria.
Don’t perform food IgE testing without a history consistent with potential IgE-mediated food allergy.
One of the AAAAI’s (American Academy of Allergy, Asthma and Immunology) “Five Things Physicians and Patients Should Question” (2012) noted that “Appropriate diagnosis and treatment of allergies requires specific IgE testing (either skin or blood tests) based on the patient’s clinical history. The use of other tests or methods to diagnose allergies is unproven and can lead to inappropriate diagnosis and treatment”. The AAAAI stated that “Don’t perform unproven diagnostic tests, such as immunoglobulin G (IgG) testing or an indiscriminate battery of immunoglobulin E (IgE) tests, in the evaluation of allergy”.
The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI): Updated Practice Parameter (2012) states: Summary Statement 127. IgG and IgG subclass antibody tests for food allergy do not have clinical relevance, are not validated, lack sufficient quality control, and should not be performed.
European Academy of Allergy and Clinical Immunology (EAACI) Food Allergy and Anaphylaxis Guidelines: diagnosis and management of food allergy
Evidence of IgE sensitization to common food and appropriate aeroallergens can support a diagnosis of food allergy in conjunction with clinical history and/or food challenge. The clinical utility of measuring serum food IgE and to generate a successful elimination diet needs further investigation. There are no unconventional tests which can be recommended as an alternative or complementary diagnostic tool in the workup of suspected food allergy, and their use should be discouraged.
The following allergy tests are considered medically necessary, if the following indications are met, with the following limits:
Percutaneous (scratch, puncture, prick) and intracutaneous (intradermal) allergy testing are considered medically necessary and, therefore, covered for the diagnosis, evaluation, and treatment of allergies when there are signs and symptoms or a diagnosis suggestive of an allergy (eg, a history of hypersensitivity to animals, food, pollen, dust mites, mold, grass, insect venoms; or asthma, allergic rhinitis, urticaria) with the following limitations:
A cumulative total of 70 scratch, puncture, or prick allergy tests are eligible for reimbursement per calendar year (CPY code 95004).
A cumulative total of 40 intracutaneous allergy tests (which should only follow negative scratch, puncture, or prick tests) are eligible for reimbursement per calendar year (CPT codes 95024 and 95028).
Skin serial endpoint titration (SET) for determination of a safe starting dose for testing or immunotherapy when there is potential for the specific allergen in question to produce a severe systemic reaction or anaphylaxis and it is an approved indication for immunotherapy. The use of serial endpoint testing should not replace routine use of prick/puncture testing. Serial endpoint titration (SET) testing (eg, intradermal dilutional testing [IDT]) is considered medically necessary with a cumulative total of 80 tests being eligible for reimbursement per calendar year (CPT codes 95017, 95018, and 95027).
Allergy testing in excess of the above limits is considered not medically necessary.
Multiallergen screening (CPT code 86005) is a qualitative test that does not quantify specific antigens; therefore, it is considered not medically necessary and not covered. Multiallergen screening is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the treatment of illness.
The following allergy tests are considered investigational because the scientific literature has not provided proof of their efficacy:
- Provocative tests (e.g. Rinkel test) for food or food additive allergies
- Nasal challenge test
- Conjunctival challenge test
- Leukocyte histamine release test (LHRT)
- Rebuck Skin Window test
- Passive transfer or P-X (Prausnitz-Kustner) test (replaced by radioallergosorbent test)
- Cytotoxic food testing
- Cyrex testing
- Food Sensitivities/LEAP Substance Profile Testing
- ALCAT test, or any blood or saliva test for food sensitivities or food allergies
- Any testing related to the Nambudripad's Allergy Elimination Technique (NAET)
- Any IgG in-vitro assay used for evaluation
- Sublingual allergy desensitization to aerollergens not recommended by the American Academy of Allergy
- HEMOCODE food intolerance testing
- Immune Blood Print test
- Reaginic pulse test or pulse testing for allergies
- Chemical analysis of body tissues
The use of in vitro (blood) (86003) allergy testing for IgE should be limited to individuals where skin testing is not possible. An initial allergy screen is up to 12 tests. Additional tests may be medically necessary if any of the initial test results are positive. If all test results are negative, additional testing beyond the initial allergy screen of 12 tests/allergens is considered not medically necessary. There would rarely be a need for testing beyond 36 test per year. Testing implemented beyond 48 tests will be denied as not medically necessary.
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.
- 82784 Gammaglobulin (immunoglobulin); IgA, IgD, IgG, IgM, each
- 82787 Gammaglobulin (immunoglobulin); immunoglobulin subclasses (eg, IgG1, 2, 3, or 4), each
- 83516 Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method
- 86001 Allergen specific IgG quantitative or semiquantitative, each allergen
- 86003 Allergen specific IgE; quantitative or semiquantitative, each allergen
- 86005 Allergen specific IgE; qualitative, multiallergen screen (dipstick, paddle, or disk)
- 86343 Leukocyte histamine release test (LHR)
- 86849 Unlisted immunology procedure
- 95004 Percutaneous tests (scratch, puncture, prick) with allergenic extracts, immediate type reaction, including test interpretation and report, specify number of tests
- 95017 Allergy testing, any combination of percutaneous (scratch, puncture, prick) and intracutaneous (intradermal), sequential and incremental, with venoms, immediate type reaction, including test interpretation and report, specify number of tests
- 95018 Allergy testing, any combination of percutaneous (scratch, puncture, prick) and intracutaneous (intradermal), sequential and incremental, with drugs or biologicals, immediate type reaction, including test interpretation and report, specify number of tests
- 95024 Intracutaneous (intradermal) tests with allergenic extracts, immediate type reaction, including test interpretation and report, specify number of tests
- 95027 Intracutaneous (intradermal) tests, sequential and incremental, with allergenic extracts for airborne allergens, immediate type reaction, including test interpretation and report, specify number of tests
- 95028 Intracutaneous (intradermal) tests with allergenic extracts, delayed type reaction, including reading, specify number of tests
- 95060 Ophthalmic mucous membrane tests
- 95065 Direct nasal mucous membrane test
- 95199 Unlisted allergy/clinical immunologic service or procedure
- U.S. Food and Drug Administration (FDA) Compliance Policy Guidelines Section 370.100; Cytotoxic Testing for Allergic Diseases(CPG 7124.27).
- American Academy of Allergy: Position Statements-Controversial techniques. Journal of Allergy and Clinical Immunology 67:333-338 1980. Reaffirmed 2012.
- Sicherer, SH. Manifestations of food allergy: Evaluation and management. American Family Physician 59:415-424, 1999
- Boyles JH Jr. A comparison of techniques for evaluating IgE-mediated allergies. Ear Nose Throat J. 2011 Apr; 90(4):164-9.
- Bernstein IL, Li JT, Bernstein DI et al. Allergy diagnostic testing: an updated practice parameter. Part 1. Ann Allergy Asthma Immunol 2008 Mar; 100(3 Suppl 3):S15-S66.
- ECRI Institute. [Product Overview] Complement Antigen Technology for Testing Food Sensitivity. 02/13/2013.
- Adkinson: Middleton’s Allergy: Principles and practice, 8th ed. Saunders, an inmrint of Elsevier, 2013.
- Boyce JA. National institute of allergy and infectious diseases: Guidelines for the diagnosis and management of food allergy in the United States: summary of the NIAID sponsored expert panel report. Nutr Res. 2011 Jan; 31(1):61-75.
- Chafen JJ, Newberry SJ, Riedl MA, Bravata DM, Maglione M, Suttorp MJ et al. Diagnosing and managing common food allergies: a systematic review. JAMA 2010;303:1848–1856.
- Keet CA, Wood RA, Matsui EC. Limitations of reliance on specific IgE for epidemiologic surveillance of food allergy. J Allergy Clin Immunol 2012;130:1207–1209.
- Muraro A, Roberts G, Worm M, Bilò M, Brockow K, Fernández-Rivas M et al. Anaphylaxis: guideline from the European Academy of Allergology and Clinical Immunology. Allergy 2014; doi: 10.1111/all.12437.
- Liao W, Hu Q, Shen LL, et al. Sublingual immunotherapy for asthmatic children sensitized to house dust mite: A meta-analysis. Medicine (Baltimore). 2015;94(24):e701.
- Makela M, Jartti T, Kolho KL, et al. Update on current care guideline: Food allergy (children). Duodecim. 2015;131(7):694-695.
- Seidman MD, Gurgel RK, Lin SY, et al; Guideline Otolaryngology Development Group. AAO-HNSF. Clinical practice guideline: Allergic rhinitis. Otolaryngol Head Neck Surg. 2015;152(1 Suppl):S1-S43.
- Pfaar O, Demoly P, Gerth van Wijk R, et al; European Academy of Allergy and Clinical Immunology. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: An EAACI Position Paper. Allergy. 2014;69(7):854-867.
- American Academy of Allergy, Asthma, & Immunology. Choosing Wisely, Released April 4, 2012 (1-5) and March 3, 2014 (6-10). Available at choosingwisely.org
Date Reason Action
September 2011 Annual review Policy renewed
September 2012 Annual review Policy revised
August 2013 Annual review Policy revised
June 2014 Annual review Policy revised
May 2015 Annual review Policy revised
April 2016 Annual review Policy revised
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.