Asset Publisher

mp-071

print Print Back Back

Allergy Testing

Policy Number: MP-071

Latest Review Date: January 2024

Category: Medical

POLICY:

Allergy testing may be considered medically necessary when clinically significant allergic symptoms exist, conservative therapy has failed or has not been tolerated by the individual. The antigens should generate an IgE mediated response and exist in the individual’s environment with a reasonable probability of exposure.

The following allergy testing modalities are considered eligible for coverage when the above medical criteria are met:

  • Direct skin testing (percutaneous and intracutaneous)
  • Specific IgE in vitro tests (RAST, MAST, FAST, & ELISA).
  • Total Serum IgE Concentration Test (only for suspected allergic bronchopulmonary. aspergillosis, immune deficiency disease characterized by elevated IgE levels, IgE myeloma, or pemphigoid).
  • Bronchial Challenge Test.
  • Oral Food/Ingestion Challenge Test.
  • Serial/Skin Endpoint Titration Test (SET).
  • Photo Patch Test.

For the above allergy testing modalities, excluding Patch and Photo Patch testing, a combination or a total of sixty-five tests every 3 years (based on dates of service) may be considered as medically necessary:

  • Retesting with the same antigen should not be necessary within 3 years unless an individual transfers to another practice or has a poor response to immunotherapy.
  • Documentation would include that the individual continues to have symptoms that interfere with activities of daily living despite optimal immunotherapy.
  • Claims for retesting or additional testing are non-covered unless supporting documentation clearly documents the medical necessity in the individual case.
  • Testing done on a separate day for different antigens is acceptable if the number of tests does not exceed the screening limits.

Patch/Photo Patch allergy testing will be considered separate from the above allergy testing modality limits. A limited series of patch tests may be an appropriate initial step. Standard panels of allergens for patch testing are available from various commercial sources. The most used patch test unit includes thirty-five common allergens and 1 negative control. In addition to the standard series of thirty-six patch tests, fourteen additional allergens targeted at the individual’s most likely exposures may be performed:

  • A combination or a total of fifty Patch/Photo Patch tests every 3 years (based on dates of service) may be considered medically necessary. 
  • Greater than fifty patch tests within 3 years may be reviewed for individual consideration.  Documentation of medical necessity for over fifty tests is required.

More comprehensive patch testing, greater than fifty patch tests, may be considered medically necessary when BOTH (A and B) are met:

       A. The individual has persistent allergic contact dermatitis (ACD) after being previously evaluated and treated (including 6 weeks of avoidance of any allergens that were positive on initial patch testing and use of topical steroid products if appropriate).

OR

           The individual has ANY of the following:

  • At least 8 weeks of dermatitis without resolution with treatment.
  • Has dermatitis that may be implanted device-related.
  • Is undergoing pre-testing for medical or dental device placement.
  • Requires extensive patch testing to determine if persistent dermatitis is allergic contact dermatitis.
  • Has seen at least one other physician who has requested specialty patch testing.

AND

     B. Dermatitis interferes with the individual’s normal activities of daily living such as: occupational or work activities (use of hands), sleep patterns (due           to itching), bathing or social interactions.

Food allergy testing is covered only in individuals with documented symptoms following ingestion of certain foods and avoidance of those foods that have not been proven to alleviate the symptoms. An initial screening of no more than twenty foods is covered with documented medical necessity.

Allergy testing performed by the following methods is considered investigational:

Conjunctival Challenge Testing /Ophthalmic mucous membrane test

  • Direct nasal mucous membrane test/ Nasal challenge test
  • Provocative Neutralization Testing (e.g., Rinkel test)
  • Cytotoxic Food Testing, Leukocytotoxic test (Bryan’s test)
  • Mediator Release Test (MRT)
  • Sage Allergy Testing
  • Leukocyte Histamine Release Test (LHRT)
  • Rebuck Skin Window Test
  • Passive Transfer of P-X (Prausnitz-Kustner) test (this test is obsolete and was replaced by radioallergosorbent tests [RAST])
  • Peanut allergen epitope assessment (e.g., VeriMAP™ peanut sensitivity)

DESCRIPTION OF PROCEDURE OR SERVICE:

The immune system is the body’s defense against harmful substances. An allergy is the immune system’s response to certain items that the immune system considers foreign and harmful, things as specific foods, animal dander, pollen, drugs, mold and many other substances. The substances that create allergic reactions are known as allergens. In people with allergies, their immune system overreacts to allergens by creating an antibody, a protein specially made to fight a particular substance, known as immunoglobulin E (IgE). Allergic reactions can cause several different types of symptoms such as a runny nose, watery eyes or hives. Serious reactions can range from breathing difficulties to life-threating swelling in the mouth or throat. Diagnosing allergies often involves testing the skin, measuring the ability to breathe or looking at IgE levels in the blood.

There are a variety of tests to identify the allergens that may be responsible for an individual’s allergic disease.  Allergy testing can be broadly subdivided into two methodologies:

  • In vivo methodologies include skin allergy testing (i.e., skin prick testing, skin scratch testing, intradermal testing, skin patch testing, and skin endpoint titration), bronchial provocation tests, and food challenges.
  • In vitro methodologies include various techniques to test the individual’s blood for the presence of specific IgE antibodies to a particular antigen (i.e., RAST and ELISA tests).

The optimum management of the allergic individual should include a careful history and physical examination and may include confirming the cause of the allergic reaction by information from various testing methods. Once the offending allergen is identified, treatment is provided by avoidance, medication and/or immunotherapy. It is essential to the care of allergic individuals to determine which allergens may be inciting their disease because this information is used to direct allergy prevention and treatment.

Direct Skin Testing

Percutaneous (scratch, prick, or puncture)

Percutaneous (scratch, prick, or puncture) tests are performed for inhalant allergies and suspected food hypersensitivity. This is covered only in individuals if the adverse food reaction is suspected to be immune-related. This will require detailed documentation of the individual’s history and a description of the reaction to the suspected foods, which should include documentation of the symptoms following ingestion of suspected foods and the modification of symptoms after the avoidance of these foods. Any additional testing would require the results of an initial screening and an individual’s history. (CPT 95004, 95017, 95018)

Intracutaneous (intradermal)

Intracutaneous (intradermal) tests are usually performed following negative prick/puncture tests and are approximately 100 to 1000-fold more sensitive. This testing is not performed in the diagnosis of food or latex allergy due to an unacceptably high rate of both false positives and systemic reactions to testing. In contrast, Intracutaneous testing is important in the diagnosis of drug and insect venom allergies. (CPT 95024, 95027, 95028)

Skin Patch Testing (application testing)

Skin patch testing (application testing) is a form of skin testing used to determine the cause of allergic contact dermatitis. Small disks or chambers containing different chemicals are taped to an individual’s back for several days. Small areas of localized inflammation may appear within 2-4 days, or even up to a week, and confirm the presence of sensitivity to a variety of substances including: metals, rubber compounds, fragrances, preservatives and sometimes medications. This form of testing is looking for delayed skin reactions, also called type IV hypersensitivity reactions, and helps the provider determine if a person’s skin inflammation is due to contact with something in their home or work environment. Skin patch testing is different from skin prick testing and is not used to diagnose immediate or acute hypersensitivity to foods and other allergens. (CPT 95044)

Photo Patch Testing

Photo patch testing reflects contact photosensitization. A patch of skin is applied with the suspected sensitizer for 48 hours. If no reaction occurs, the area is exposed to a dose of ultraviolet light sufficient to produce inflammatory redness of the skin. If the test is positive, a more severe reaction develops at the patch site than on the surrounding skin. (CPT 95052)

Inhalation Bronchial Testing

Methacholine challenge test does not include necessary pulmonary function tests.  Histamine, cold air or methacholine is used to perform this test when it is necessary to determine if the individual has hyper-responsive airways. Volatile chemicals are used to perform the test when the allergy is encountered in an occupational setting. If dust, ragweed or other common allergens are the suspected cause of the problem, this test is not medically appropriate since skin tests can be used in these situations. Infrequently, aerosol challenge is indicated for occupational exposures (e.g., plicatic acid for cedar workers and fish extracts for fishermen). (CPT 95070)

Oral Food/Ingestion Challenge Testing

Oral Food/Ingestion challenge test is a sequential and incremental ingestion of test items (e.g., food, drug or other substance), also known as the “Double Blind Food Test”. The physician has the individual ingest specific substances, such as food or drugs to determine which sensitivity is suspected, to show that a hypersensitivity no longer exists and to determine a sensitivity when a history is vague or allergy testing is equivocal. The individual is observed by qualified medical staff during the challenge. The observation and any reactions are documented. Truly double-blinded challenges are rarely performed in clinical practices and are usually done in research studies. (CPT 95076, 95079)

Gamma Globulin/Immunoglobulin E (IgE) Testing

Gamma Globulin/Immunoglobulin E (IgE) is a testing modality not indicated in most allergic individuals but may be indicated for those individuals suspected of having an allergic bronchopulmonary aspergillosis immune deficiency disease characterized by increased IgE levels (e.g., Wiskott-Aldrich syndrome, hyper-IgE staphylococcal abscess syndrome, IgE myeloma or pemphigoid). (CPT 82785)

Allergen-Specific Immunoglobulin E (IgE) Testing

Allergen-specific immunoglobulin E (IgE) test detects specific IgE antibodies in an individual’s serum. This Test is medically appropriate only when testing for allergens (e.g., inhalant, food, insect, drug) when direct skin testing is impossible due to extensive dermatitis or marked dermatographism, individuals unable to discontinue use of antihistamines or other interfering medications (e.g., antidepressants, beta blocking agents) or those who have had a near fatal reaction to an allergen. (CPT 86003, 86005)

In Vitro Testing

In vitro testing is done when the history is suggestive of an allergy, but skin testing is negative or equivalent. It is also done to follow individuals with food allergies for prognostic purposes and for confirmation of the loss of an allergy before an oral challenge. After a careful history is obtained, the individual’s symptoms must indicate a possibility of a hypersensitivity reaction. Medical necessity is not established for in-vitro testing if there are no allergy symptoms. These tests include radioallergosorbent test (RAST), multiple radioallergosorbent tests (MAST), fluorescent allergosorbent test (FAST), and enzyme-linked immunosorbent assay (ELISA).

Skin Endpoint Titration Testing

Skin endpoint testing (Serial Endpoint Titration [SET], Serial Dilution Endpoint Titration [SDET], Intradermal Testing [IDT]) is a form of intradermal skin testing that uses increasing doses of antigen to determine the concentration at which the reaction changes from negative to positive (the “endpoint”). It is the weakest dilution that produces a positive skin reaction and initiates progressive increase in the diameter of the wheals with each stronger dilution. SET has also been used to guide the initiation of immunotherapy by using the endpoint dilution as the starting antigen dose. (CPT 95027)

Conjunctival Challenge Testing /Ophthalmic Mucous Membrane Test

Conjunctival challenge test, also known as an ophthalmic mucous membrane test, is done by placing an allergenic extract into the conjunctival sac of the eye followed by observation for redness, itchiness, tearing of the eye, and other similar symptoms. This testing modality is non-covered and investigational as it has not been proven to be effective. (CPT 95060)

Direct Nasal Mucous Membrane Test/Nasal Challenge Test

Direct nasal mucous membrane test, also known as nasal challenge test, provides precise measurements of changes in nasal airway resistance and is seldom used because of the instrumentation required. This test is used in studies of allergic rhinitis, but its utility in clinical practice has not been established. The role of nasal challenge testing in the diagnosis and management of allergic diseases has not been established. (CPT 95065)

Provocative Neutralization Testing

Provocative testing (e.g., Rinkel test) is a procedure that evolved from serial endpoint titration and has been proposed as a test for allergies to foods, inhalants and environmental chemicals. Individuals are exposed to test doses of substances intradermally, subcutaneously or sublingually, with the goal of either producing or preventing symptoms. This is an unproven test.

Cytotoxic Food Testing, Leukocytotoxic Test

Cytotoxicity, Leukocytotoxic test (Bryan’s test, Metabolic Intolerance Test or cytoxic testing) is a test in which leukocytes from the serum of an allergic individual are observed for histamine release in the presence of an antigen. This test is rarely done except in a research setting. There is no proof that this is effective for foods or pollens.

Leukocyte Histamine Release Test (LHRT)

Leukocyte Histamine Release Test (LHRT) is a test which measures the amount of histamine released from the white blood cells in response to exposure to an antigen. The published literature is not sufficient to permit conclusions on the diagnostic accuracy of LHRT.

Rebuck Skin Window Test

Rebuck Skin Window Test is a test of the inflammatory process. The skin is abraded and a cover applied to the abraded area. The cover is replaced at specified intervals and examined for the presence of immune response cells. This testing modality is non-covered and investigational as it has not been proven to be effective. This test is not useful in documenting allergies since other immunodeficiencies can be found in individuals with allergic conditions.

Passive Transfer of P-X (Prausnitz-Kustner Test)

Passive Transfer of P-X (Prausnitz-Kustner Test) is performed by injecting a serum intradermally from an allergic individual into a non-allergic individual and later challenging the injection site with antigens or danger of transferring infections. This testing modality is non-covered and investigational as it has not been proven to be effective.

Mediator Release Test

The MRT has primarily been used to detect intolerance to foods and additives in individuals with irritable bowel syndrome (IBS). It has also been promoted for use in individuals with, but not limited to chronic fatigue syndrome, migraine headaches, rheumatologic disorders and dermatologic conditions. The results of the MRT have been used to design a patient-specific diet. This testing modality is non-covered and investigational as it has not been proven to be effective.

Peanut Allergen Epitope Assessment/Mapping

The VeriMAP Peanut Dx is a peanut allergen-specific IgE and quantitative assessment of 64 epitopes using enzyme-linked immunosorbent assay (ELISA) combined with Luminex’s bead-based xMAP® Technology to measure the reactivity of an individual’s antibodies to each epitope in order to generate a detailed reactivity profile. This testing modality is non-covered and investigational as it has not been proven to be effective.

KEY POINTS:

Literature review performed through January 5, 2024.

Summary of Evidence

The American Academy of Allergy, Asthma and Immunology (AAAAI) in its allergy report cites that each year more than fifty million Americans suffer from allergic disease. Rhinitis, sinusitis, dermatitis, asthma, food allergy, and other allergic disorders negatively impact quality of life and escalate healthcare costs. Allergies are the 6th leading cause of chronic disease in the United States and are costing the healthcare system over $18 billion annually.

Atopic Dermatitis

Atopic dermatitis (AD), also known as atopic eczema, is a chronic relapsing inflammatory skin condition. Incidence of AD has increased 2- to 3-fold in industrialized nations, impacting approximately 15% to 20% of children and 1% to 3% of adults worldwide. "Atopic" means that there is typically a genetic tendency toward allergic disease. Atopic dermatitis usually begins in the first few years of life and is often the initial indication that a child may later develop asthma and/or allergic rhinitis (hay fever). In infants, eczema usually appears as tiny bumps on the cheeks. Older children and adults often experience rashes on the knees or elbows (often in the folds of the joints), on the backs of hands or on the scalp. Symptoms of atopic dermatitis (eczema) include:

  • Patches of skin that are red or brownish
  • Itchy skin, especially at night
  • Dry cracked or scaly skin

Allergic Rhinitis

Allergic rhinitis individual’s immune system mistakenly identifies a typically harmless substance as an intruder, called an allergen. The immune system responds to the allergen by releasing histamine and chemical mediators that typically cause symptoms in the nose, throat, eyes, ears, skin and roof of the mouth. Seasonal allergic rhinitis (hay fever) is most often caused by pollen carried in the air during different times of the year in different parts of the country. Allergic rhinitis can also be triggered by common indoor allergens such as the dried skin flakes, urine and saliva found on pet dander, mold, droppings from dust mites and cockroach particles. This is called perennial allergic rhinitis, as symptoms typically occur year-round. In addition to allergen triggers, symptoms may also occur from irritants such as smoke and strong odors, or to changes in the temperature and humidity of the air. This happens because allergic rhinitis causes inflammation in the nasal lining, which increases sensitivity to inhalants. Many people with allergic rhinitis are prone to allergic conjunctivitis (eye allergy). In addition, allergic rhinitis can make symptoms of asthma worse for people who suffer from both conditions.

Asthma

Allergic asthma is the most common form of asthma. Many of the symptoms of allergic and non-allergic asthma are the same. However, allergic asthma is triggered by inhaling allergens. An allergen is a typically harmless substance such as dust mites, pet dander, pollen or mold. If you are allergic to a substance, this allergen triggers a response starting in the immune system. Through a complex reaction, these allergens then cause the passages in the airways of the lungs to become inflamed and swollen. This results in coughing, wheezing and other asthma symptoms.

Food Allergies

In food allergies, the immune system overreacts to a particular protein found in that food. Symptoms can occur when coming in contact with just a tiny amount of the food. Many food allergies are first diagnosed in young children, though they may also appear in older children and adults. Most adverse food reactions in adults are due to various forms of food intolerance, which are nonimmunologic reactions.

Eight foods are responsible for the majority of allergic reactions:

  • Cow’s milk
  • Eggs
  • Fish
  • Peanuts
  • Shellfish
  • Soy
  • Tree nuts
  • Wheat

Clinical features of food intolerances traverse a spectrum of organ systems and vary among different disorders, although most involve prominent gastrointestinal symptoms. Excessive intestinal gas, bloating, abdominal pain, and diarrhea are common symptoms.

Allergy Testing

The purpose of allergy testing is to identify the allergens that contribute to the allergic disease process. By identifying the allergen, the individual can avoid exposure, and the disease can be managed appropriately. Allergy testing can be performed for a variety of aeroallergens (inhalant allergens), foods, latex, venom and some medications. The Annals of Allergy, Asthma, & Immunology, March 2008 summary statement 43, “The number of skin tests and the allergens selected for skin testing should be determined based on the individual’s age, history, environment and living conditions (e.g., region of the country), occupation, and activities. Routine use of large numbers of skin tests or routine annual tests without a definite clinical indication are not justified.”

Skin testing is a major method for identifying allergen-specific immunoglobulin E (IgE). In-vivo testing techniques are divided into two general categories: percutaneous and intradermal tests. Intradermal tests are used commonly when a significant history is obtained and the results of the percutaneous tests are negative or equivocal. In vivo tests, most commonly skin tests, are viewed by many as the most relevant indicator of IgE antibody since they involve direct observation of a biological response in the individual. It remains the primary method used by allergists to detect IgE antibodies, because of its sensitivity, specificity, speed, cost-effectiveness, and ease of performance. Skin tests may be performed by several methods including prick or puncture, and intradermal techniques.

In-vitro testing is indicated for individuals who have severe cutaneous disease, cannot discontinue medications that interfere with skin testing, or have experienced severe anaphylaxis. These tests were developed to measure serum levels of antigen-specific IgE. In vitro methods for the detection of allergen-specific IgE in serum offer different advantages when compared to in vivo tests. They may offer potentially better quantitation, the ability to detect IgE antibodies in the presence of dermatographism, a lack of drug interference by antihistamines and related medications, and the potential for long-term storage of serum specimens for longitudinal testing.

Radioallergosorbent test (RAST) and enzyme-linked immunosorbent assay (ELISA) are commonly used.

Practice Guidelines and Position Statements

American Academy of Allergy, Asthma & Immunology (AAAAI)

In 2014, the AAAAI website listed several tests that it believes “are not useful, effective, or may lead to inappropriate diagnosis and treatment.” These tests include:

  • Allergy screening tests done in supermarkets or drugstores
  • Applied kinesiology (allergy testing by testing muscle strength or weakness)
  • Cytotoxicity testing for food allergy
  • Home testing
  • Immunoglobulin G (IgG) testing for food allergy
  • Rinkel skin titration method
  • Provocative neutralization testing
  • Sublingual provocation

National Institute of Allergy and Infectious Diseases (NIAID)

In 2017, the NIAID published addendum guidelines for the prevention of peanut allergy in the United States. These guidelines note that the expert panel (EP) “recommends that evaluation with peanut-specific IgE (peanut IgE) measurement, SPTs, or both be strongly considered before introduction of peanut to determine if peanut should be introduced and, if so, the preferred method of introduction.

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.

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.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Gammaglobulin, IgE, allergen, intradermal, percutaneous, intracutaneous, provocative testing, bronchial challenge testing, direct skin test, patch test, application test, photo patch test, ingestion challenge test, serial endpoint  testing, SET, ophthalmic mucous membrane test, direct nasal mucous membrane test, Rinkel test, cytotoxic testing, leukocytotoxic test, Bryan’s test, Metabolic intolerance test, Radioallergosorbent test, RAST, Multiple radioallergosorbent test, MAST, Fluorescent allergosorbent test, FAST, Enzyme-linked immunosorbent assay, ELISA, in-vivo, in-vitro, RUSH immunotherapy, mediator release test, MRT, LEAP, Sage allergy testing, T.R.U.E® Test,  Oral Food Challenge, skin endpoint titration, Cytotoxic Food Testing, Provocative Neutralization Testing, Conjunctival Challenge Testing, VeriMAP, Peanut Allergen Epitope Mapping, Bead-Based Epitope Assay (BBEA).

APPROVED BY GOVERNING BODIES:

Not applicable.

BENEFIT APPLICATION:

Coverage is subject to the member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to the member’s benefit plan.

CURRENT CODING:

CPT Codes:

0165U

Peanut allergen-specific quantitative assessment of multiple epitopes using enzyme-linked immunosorbent assay (ELISA), blood, individual epitope results and probability of peanut allergy

0178U

Peanut allergen-specific quantitative assessment of multiple epitopes using enzyme-linked immunosorbent assay (ELISA), blood, report of minimum eliciting exposure for a clinical reaction

82785

Gammaglobulin (immunoglobulin); IgE

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, crude allergen extract, each

86005

Allergen specific IgE; qualitative, multi allergen screen (disk, sponge, card)

86008

Allergen specific IgE; quantitative or semiquantitative, recombinant or purified component, each

86343

Leukocyte Histamine Release Test (LHR) 

86486

Skin test; unlisted antigen, each

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

95044

Patch or application test(s) (specify number of tests) 

95052

Photo patch test(s) (specify number of tests)

95056

Photo tests

95060

Ophthalmic mucous membrane tests

95065

Direct nasal mucous membrane test

95070

Inhalation bronchial challenge testing (not including necessary pulmonary function tests); with histamine, methacholine, or similar compounds

95076

Ingestion challenge test (sequential and incremental ingestion of test items, e.g., food, drug or other substance); initial 120 minutes of testing

95079

; each additional 60 minutes of testing (List separately in addition to code for primary procedure)

95199

Unlisted Allergy/Clinical Immunologic Service or Procedure

REFERENCES:

  1. American Academy of Allergy, Asthma, & Immunology. AAAAI to Release Choosing Wisely® List at the 2014 Annual Meeting. enews.aaaai.org/february-2014/news-briefs/aaaai-to-release-choosing-wisely-list-at-the-2014-annual-meeting.
  2. American Academy of Allergy Asthma and Immunology. AAAAI Work Group Report: Allergy Diagnosis in Clinical Practice. November, 2006. www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20and%20Parameters/Allergy-Diagnosis-2006.pdf
  3. American Academy of Allergy Asthma and Immunology. Allergy Diagnostic Testing: An Updated Practice Parameter, www.aaaai.org/Aaaai/media/Media-Library-PDFs/Allergist%20Resources/Statements%20and%20Practice%20Parameters/allergydiagnostictesting.pdf.
  4. American Academy of Allergy Asthma and Immunology. Allergy Diagnostic Testing: An Updated Practice Parameter, www.aaaai.org/Aaaai/media/Media-Library-PDFs/Allergist%20Resources/Statements%20and%20Practice%20Parameters/allergydiagnostictesting.pdf.
  5. American Academy of Allergy Asthma and Immunology. Allergy Diagnostic Testing: An Updated Practice Parameter. 2008 www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20and%20Parameters/allergydiagnostictesting.pdf
  6. American Academy of Allergy, Asthma & Immunology. Don’t perform unproven diagnostic tests, such as immunoglobulin G(lgG) testing or an indiscriminate battery of immunoglobulin E(lgE) tests, in the evaluation of allergy. www.choosingwisely.org/clinician-lists/american-academy-allergy-asthma-immunology-diagnostic-tests-for-allergy-evaluation/.
  7. American Academy of Allery Asthma and Immunology. Food Allergy www.aaaai.org/tools-for-the-public/conditions-library/allergies/food-allergy-ttr.
  8. American Academy of Allergy: Position Statements-Controversial techniques. J Allergy Clin Immunol. 1981 May;67(5):333-8.
  9. Ansotegui IJ, Melioli G, Canonica GW, et al. IgE allergy diagnostics and other relevant tests in allergy, a World Allergy Organization position paper. World Allergy Organ J. 2020 Feb 25;13(2):100080 Erratum in: World Allergy Organ J. 2021 Jun 17;14(7):100557.
  10. Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care. 2017 Jun;23(8 Suppl):S115-S123.
  11. Bernsteinet al. Allergy diagnostic testing: An updated practice parameter. American College of Allergy, Asthma and Immunology. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008 Mar;100(3 Suppl 3):S1-148.
  12. Bogh, et al. IgE versus IgG4 epitopes of the peanut allergen Ara h 1 in patients with severe allergy. Mol Immunol. 2014;58(2):169-176.
  13. Boyce, J. A., Assa’ad, A., Burks, W. W., Jones, S. M., Sampson, H. A., Wood, R. A., et al. (2010). Guidelines for the Diagnosis and Management of Food Allergy in the United States: Summary of the NIAID-Sponsored Expert Panel Report. Journal of Allergy Clinical Immunology, 126 (6 Suppl), S1-S58.
  14. Boyles JH, Jr. A comparison of techniques for evaluating IgE-mediated allergies. Ear Nose Throat J 2011; 90(4):164-9.
  15. Bracken SJ, Abraham S and MacLeod AS (2019) Autoimmune Theories of Chronic Spontaneous Urticaria. Front. Immunol. 10:627.
  16. Centers for Disease Control and Prevention. More than a Quarter of U.S. Adults and Children Have at Least One Allergy, January  2023. www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/20220126.htm
  17. Chen X, Negi SS, Liao S, et al. Conformational IgE epitopes of peanut allergens Ara h 2 and Ara h 6. Clin Exp Allergy. 2016;46(8):1120-1128.
  18. Commins, S., Feldweg, A., Sicherer, S. Food intolerance and food allergy in adults: An overview. www.uptodate.com/contents/food-intolerance-and-food-allergy-in-adults-an-overview?search=allergy%20testing&source=search_result&selectedTitle=5~150&usage_type=default&display_rank=5.
  19. Fornadley JA. Skin testing for inhalant allergy. Int Forum Allergy Rhinol. 2014 Sep;4 Suppl 2:S41-S45.
  20. Hamilton RG, Franklin Adkinson N Jr.  In vitro assays for the diagnosis of IgE-mediated disorders. J Allergy Clin Immunol. 2004 Aug;114(2):213-25; quiz 226.
  21. He, Y. T., Reisacher, WR. Sensitivity, specificity, and predictive value of oral mucosal brush biopsy for the diagnosis of peanut allergy. Int Forum Allergy Rhinol, 2019 Jun,9(6): 624-628.
  22. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  23. Jones SM, Kim EH, Nadeau KC, et al. Immune Tolerance Network. Efficacy and safety of oral immunotherapy in children aged 1-3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study. Lancet. 2022 Jan 22;399(10322):359-371. 
  24. Kappen J, Diamant Z, Agache I, Bonini M, Bousquet J, Canonica GW, Durham SR, Guibas GV, Hamelmann E, Jutel M, Papadopoulos NG, Roberts G, Shamji MH, Zieglmayer P, Gerth van Wijk R, Pfaar O. Standardization of clinical outcomes used in allergen immunotherapy in allergic asthma: An EAACI position paper. Allergy. 2023 Nov;78(11):2835-2850 Epub 2023 Jul 14.
  25. Lowell FC. Editorial: Some untested diagnostic and therapeutic procedures in clinical allergy. J Allergy Clin Immunol. 1975 Sep;56(3):168-169.
  26. Nevis IF, Binkley K, Kabali C. Diagnostic accuracy of skin-prick testing for allergic rhinitis: a systematic review and meta-analysis. Allergy Asthma Clin Immunol. 2016 April 27;12:20.
  27. Shen M, Joshi AA, Vannam R, et al. Epitope-Resolved Detection of Peanut-Specific IgE Antibodies by Surface Plasmon Resonance Imaging. Chembiochem. 2018 Feb 2;19(3):199-202.
  28. Sicherer, SH, Wood, RA, Abramson, S, et al.(2012) Allergy Testing in Childhood: Using Allergen-Specific IgE Tests. Pediatrics, 129(1): 193-197.
  29. Suprun M, Getts R, Raghunathan R, et al. Author Correction: Novel Bead-Based Epitope Assay is a sensitive and reliable tool for profiling epitope-specific antibody repertoire in food allergy. Sci Rep. 2020 Feb 13;10(1):2872.
  30. Togias A, Cooper SF, Acebal ML, et al. (2017). Addendum guidelines for the prevention of peanut allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-sponsored expert panel. J Allergy Clin Immunol. Jan;139(1): 29-44.
  31. Viswanathan RK, Biagtan MJ, Mathur SK. The role of autoimmune testing in chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2012 May;108(5):337-341.e1.

POLICY HISTORY:

Medical Policy Group, October 2002 (1)

Medical Policy Administration Committee, October 2002

Available for comment December 18, 2002-February 3, 2003

Medical Policy Group, May 2005 (1)

Medical Policy Administration Committee, May 2005

Available for comment May 21-July 4, 2005

Medical Policy Group, February 2006 (1)

Medical Policy Administration Committee, February 2006

Available for comment February 10-March 27, 2006

Medical Policy Group, September 2006 (1)

Medical Policy Administration Committee, September 2006

Available for comment September 22-November 5, 2006

Medical Policy Group, May 2007 (1)

Medical Policy Administration Committee, May 2007

Available for comment May 31-July 16, 2007

Medical Policy Group, November 2008 (1)

Medical Policy Group, June 2010 (1): No policy changes

Medical Policy Group, January 2011 (1): Code update

Medical Policy Group, March 2011 (1): Updated Key Words and Coding

Medical Policy Group, June 2011 (1): Updated Key Points and References

Medical Policy Group, June 2012 (1): Update to Key Points and References

Medical Policy Group, November 2012 (1): 2013 Code Updates – Added Codes 95017, 95018, 95076, 95079; deleted codes 95010, 95015, & 95075; verbiage update on codes 95004, 95024, and 95027, all effective January 1, 2013

Medical Policy Panel, June 2013

Medical Policy Group, September 2013 (1): Updated with literature review; policy statement unchanged

Medical Policy Group, April 2015 (6):  Updates to Policy statement and Key Points. Patch testing (95044) and Photo Patch Testing (95052) to be considered separately for coverage.

Medical Policy Administration Committee, May 2015

Available for comment May 8 through June 21, 2015

Medical Policy Group, February 2017 (6): Updated coding in Description, removed “if performed in the office, considered to be part of the office visit and no additional benefits are provided” from the policy statement section. No change to policy intent.

Medical Policy Group, December 2017: Annual Coding Update 2018.  Added new CPT code 86008 effective 1/1/18 to Current Coding. Updated verbiage for revised CPT code 86003 and 86005.

Medical Policy Group April 2018 (6): Edited description of code 86003 in Description section to include “antihistamines”. No change to policy statement.

Medical Policy Group, June 2019 (6): Updated Description, Policy statement clarification, T.R.U.E. TEST® by Allerderm removed, Key Points, Practice Guidelines, Key Words and References. No change to policy intent.

Medical Policy Group, December 2020 (6): Updates to Description, Policy statement to include non-coverage of Peanut allergen epitope assessment (e.g. VeriMAP peanut sensitivity); Verimap/peanut allergen epitope assessment was previously non-covered per internal processing, Key Points, Practice Guidelines, Coding (0165U/0178U/86343), Key Words (VeriMAP, Peanut Allergen Epitope Mapping, Bead-Based Epitope Assay (BBEA), and References.

Medical Policy Group, January 2022 (5): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Key Points, and References.

Medical Policy Group, December 2022 (5): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Description, Key Points, and References. Policy Statement updated to replace the word “patients” with the word “individuals.” No change to policy intent. 

Medical Policy Group, December 2023 (9): Reviewed by consensus. No new published peer-reviewed literature is available that would alter the coverage statement in this policy. Updates to Description, Key Points, Benefit Application, and References. Update to current coding section to remove the code 95071 (deleted 01/01/21). No change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

  1. The technology must have final approval from the appropriate government regulatory bodies;
  2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
  3. The technology must improve the net health outcome;
  4. The technology must be as beneficial as any established alternatives;
  5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

  1. In accordance with generally accepted standards of medical practice; and
  2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
  3. Not primarily for the convenience of the patient, physician or other health care provider; and
  4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.