Medical Policy Allergy Testing Type:

Policy Specific Section:

Medical Necessity and Investigational / Experimental

Laboratory/Pathology

Original Policy Date:

Effective Date:

June 28, 2013

June 28, 2013

Definitions of Decision Determinations Medically Necessary: A treatment, procedure or drug is medically necessary only when it has been established as safe and effective for the particular symptoms or diagnosis, is not investigational or experimental, is not being provided primarily for the convenience of the patient or the provider, and is provided at the most appropriate level to treat the condition. Investigational/Experimental: A treatment, procedure or drug is investigational when it has not been recognized as safe and effective for use in treating the particular condition in accordance with generally accepted professional medical standards. This includes services where approval by the federal or state governmental is required prior to use, but has not yet been granted. Split Evaluation: Blue Shield of California / Blue Shield of California Life & Health Insurance Company (Blue Shield) policy review can result in a Split Evaluation, where a treatment, procedure or drug will be considered to be investigational for certain indications or conditions, but will be deemed safe and effective for other indications or conditions, and therefore potentially medically necessary in those instances. Description An allergy is an abnormal reaction to an ordinarily harmless substance called an allergen. Allergic or hypersensitivity disorders may be manifested by generalized systemic reactions as well as localized reactions in any organ system of the body. The reactions may be acute, subacute or chronic, immediate, or delayed and may be caused by numerous offending agents,

Medical Policy: Allergy Testing Original Policy Date: 6/28/2013 Effective Date: 6/28/2013

(e.g., pollen, molds, dust, mites, animal dander, stinging insect venom, foods, and double-blind food challenge tests). Allergy testing can be broadly subdivided into in vivo and in vitro 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 allergy tests include various techniques to test the blood for the presence of specific IgE antibodies to a particular antigen (i.e., RAST and ELISA tests). Skin prick testing and in vitro analyses of IgE are the most commonly performed allergy tests. The optimum management of the allergic patient should include a careful history and physical examination and may include confirming the cause of allergic reaction by information from some of the testing methods outlined below. Once the agent is identified, treatment is provided by avoidance, medication or immunotherapy. Policy The following allergy testing techniques may be considered medically necessary in the diagnosis of an allergic patient, when ordered by a physician: 

Direct skin testing (for immediate hypersensitivity) by any of the following modalities:  Percutaneous (scratch, prick, or puncture)  Intracutaneous (intradermal)

  

Patch testing (also known as application testing) Photo-patch testing Specific IgE in vitro tests as indicated for inhalant allergens (pollens, molds, dust, mites, animal dander), foods, insect sting and other allergens (e.g., drugs) when both of the following are met:  Any of the following specific IgE in vitro tests*:      

Radioallergosorbent Test (RAST) Multiple radioallorgosorbent Tests (MAST) Fluorescent allergosorbent Test (FAST) Enzyme-linked Immunosorbent Assay (ELISA) ImmunoCAP® Paper Radioimmunosorbent Test (PRIST)

 Any of the following reasons:  When direct skin-testing is impossible due to extensive dermatitis or marked dermatographism  In children younger than 4 years of age or adults with mental or physical impairments whereby direct skin testing is impossible  When clinical history suggests an unusually greater risk of anaphylaxis from skin testing than usual

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Medical Policy: Allergy Testing Original Policy Date: 6/28/2013 Effective Date: 6/28/2013

 Inability to discontinue medication (e.g., antihistamines, beta-blockers) that impair skin test sensitivity  A standardized or commercial skin test is not available for the allergen in question  Skin testing is negative in the face of a strong clinical suspicion for an allergen/allergens (i.e., direct skin testing is not consistent with history of anaphylactic or other severe reactions) *Note: Specific IgE in vitro testing should include testing only for those allergens that could be reasonably suspected regardless of test kit packaging. Initial diagnostic screening is limited to 36 allergen specific antibodies. Additional testing beyond this number will require individual review for medical necessity. 

Total serum IgE concentration in patients suspected of having any of the following conditions:  Allergic bronchopulmonary aspergillosis  Immune deficiency disease (i.e., Wiskott-Aldrich syndrome, hyper-IgE staphylococcal abscess syndrome)  IgE myeloma  Pemphigoid



 

Oral challenge testing or double-blind food challenge testing for any of the following: o Food or other substances (i.e., additives or preservatives) o Drugs when either of the following the following are met:  Allergy to multiple classes of drugs within a drug category is suspected (i.e., allergic to penicillin, and cephalosporins)  History of allergy to a particular drug; and treatment with the drug is essential Certain bronchial challenge tests (See Policy Guideline) Serial endpoint testing (SET) (also known as skin endpoint titration) when both of the following criteria are met:  When used for the determination of a safe starting dose for testing or immunotherapy  Where there is a potential for the specific allergen in question to produce a severe systemic allergic reaction (i.e., chemicals, drugs, bee venom or peanuts)

The above allergy testing techniques are considered not medically necessary when the medical criteria and policy guidelines (as applicable) are not met. The following allergy tests are considered investigational in the diagnosis of the allergic patient:      

Antigen leukocyte cellular antibody test (ALCAT) Applied kinesiology (or muscle strength test) Complement antigen testing Conjunctival challenge testing (ophthalmic mucous membrane test) Cytotoxic food tests (leukocytotoxic test or Bryan’s Test) Electrodermal testing (also known as electro-acupuncture)

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Medical Policy: Allergy Testing Original Policy Date: 6/28/2013 Effective Date: 6/28/2013

            

Hair analysis IgG/IgG4 allergen specific antibody or food test (serum IgG/IgG4 levels) In vitro metal allergy testing (also known as lymphocyte transformation tests [LTT]) Iridology Leukocyte histamine release testing (LHRT) Mediator release test (MRT) Nambudripad's allergy elimination technique (NAET) Nasal challenge test (also known as nasal mucous membrane test; nasal challenge/provocation test) Passive transfer of P-X (Prausnitz-Kustner test) Provocation neutralization testing (or the food additive allergy test, also referred to as the Rinkel test) Provocative tests for food or food additive allergies Rebuck skin window test Sublingual provocation food testing

Policy Guideline The following tables represent the medically necessary (Table I) and investigational (Table II) tests discussed in the policy statement and associated test descriptions and coding when associated with allergy testing.

Table I Medically Necessary

Description/Instruction

Code(s)

Intradermal (or intracutaneous) skin testing is performed by injection of 0.02 to 0.05 mL of a 1:500 to 1:1000 weight/volume allergen extract into the skin. A positive intradermal result is a wheal of 5 mm or larger in most instances (some use > 3 mm)

95004 95017 95018 95024 95027 95028

Allergy Tests Direct skin testing

The number of tests required may vary widely from patient to patient, depending upon the patient’s history and geographical location. In general, 40 percutaneous or 20 intracutaneous tests may be required. However, evaluation of inhalant allergy may require up to 70 prick/puncture tests followed by 40 intradermal tests, which are ordinarily performed when prick/puncture tests are negative. In most cases, fewer tests are required.

IgE in vitro tests (RAST/MAST/FAST/ELISA/

These tests detect antigen-specific IgE antibodies in the patient’s serum.

86003 86005

IMMUNOCAP/PRIST)

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Medical Policy: Allergy Testing Original Policy Date: 6/28/2013 Effective Date: 6/28/2013

Patch testing (application testing)

Various commercial sources provide standard panels of allergens. For example, the Thin-Layer Rapid Use Epicutaneous Patch Test unit [T.R.U.E.TEST®], (Mekos Laboratories AS, Hillerod, Denmark) contains 3 adhesive panels consisting of allergen and allergen mix patches and a negative control. In addition to the standard series of 36 patch tests, 6 additional allergens targeted at the patient’s most likely exposures may be performed initially. Patients are evaluated 48 hours after the patch test, but an additional reading at 72 and/or 96 hours is necessary.

95044

More extensive patch testing (> 42 patch tests) may be considered medically necessary when both of the following are met: 

Patients have persistent allergic contact dermatitis 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); and



When the dermatitis interferes with the patient’s normal activities of daily living, such as occupational or work activities (use of hands), sleep patterns (due to itching), bathing or social interactions

Photo-patch testing

This test reflects contact photosensitization. A photosensitivity (sensitivity to sunlight) reaction may be suspected when a rash appears only in areas exposed to sunlight. The reaction may be caused by various drugs, substances applied to the skin (drugs or cosmetics), chemicals, etc. Photo-patch testing involves applying two identical sets of allergens to the back on day one. One of the sets is exposed to UVA light, and the sites are then examined as usual. A positive photo-patch test is recorded when an allergic reaction appears only on the light-exposed site.

95052 95056

Oral Challenge Testing

With oral challenge testing, a suspected allergen is administered in an attempt to reproduce symptoms. In some clinical situations, the allergen must be confirmed. A food challenge test involves provoking an allergic reaction. Therefore, this test should always take place at a site that is well-equipped to deal with any sort of reaction.  95076 - Ingestion challenge test; initial 120 minutes of testing  95079 – Each additional 60 minutes (95079 is used in conjunction with 95076 This testing modality is not indicated for most allergic patients, but may be indicated for those patients suspected of having 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 or for consideration of Xolair administration in patients with moderate-to-severe asthma.

95076 95079

Histamine or methacholine is used to perform this test when it is

95070

Total Serum IgE Concentration

Bronchial Challenge

82785

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Medical Policy: Allergy Testing Original Policy Date: 6/28/2013 Effective Date: 6/28/2013

Test

necessary to determine if the patient has hyper-responsive airways. Volatile chemicals are used to perform the test when the allergy is encountered in an occupational setting. Such testing is generally reserved for the difficult asthmatic patient in whom routine skin testing is not sufficient to isolate the factors responsible for the asthma. If dust, ragweed, or other common allergens are the suspected cause of the problem, this test is generally considered not medically necessary, 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).

95071

Serial Endpoint Testing

Also known as skin endpoint titration (SET), intradermal dilutional testing (IDT), serial endpoint titration, 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”). The test has been used to diagnose in diagnosing allergic disorders, and is a potential alternative to other diagnostic tests such as skin prick testing or in vitro testing for this purpose. It has also been used to guide the initiation of immunotherapy, by using the endpoint dilution at the starting antigen dose.

95027

Table II Investigational Allergy Tests

Description

Rationale

Codes

Antigen leukocyte cellular antibody test (ALCAT)

The antigen leukocyte cellular antibody test (ALCAT) is a blood test using an automated method of testing food allergies, chemicals and environmental stimuli using a modified Coulter counter linked to a computer program. Typically, results are used to establish elimination diets.

There is insufficient evidence in the peer-reviewed scientific literature to establish the clinical utility or support the use of this testing in the diagnosis and/or management of allergies.

83516*

Applied kinesiology [AK] (or muscle strength test)

Muscle strength is measured before and after a person is exposed to an allergen. Strength in opposing arm is measured as a person holds a container of allergen extract in the opposite side or ingests an allergen. A decrease in strength indicates the presence of disease and various

According to the AAAAI* and the ACAAI** there is “no evidence of diagnostic validity” of AK (Bernstein et al., 2008). There is insufficient evidence in the peer-reviewed scientific literature to establish the clinical utility or support the use of this testing in the diagnosis and/or management

No specific code.

*IE when used to report ALCAT

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Medical Policy: Allergy Testing Original Policy Date: 6/28/2013 Effective Date: 6/28/2013

nutritional supplements may be recommended.

of allergies.

Complement antigen testing

This test is proposed for use to in identifying delayed food and food additive allergies. Examples of this testing include the SAGE Complement Antigen Test, the Brendan Bioscience Complement Antigen Test (screens for 132 food and food additives), and the C3b LLC Complement Antigen Test which measures antigenspecific IgG and Complement C3.

This testing has yet to be studied and validated. There is insufficient evidence in the peer-reviewed scientific literature to determine whether this test impacts treatment decisions or health outcomes in patients with allergies.

Conjunctival challenge testing (ophthalmic mucous membrane test)

An allergen extract is placed in the conjunctival sac of the eye followed by observation for redness, itchiness, tearing of the eye, and other similar symptoms. These tests are often used in research protocols that require an objective standard for evaluating clinical sensitivity to an allergen (American Academy of Allergy, Asthma, and Immunology [AAAI], 2000).

95060 The test is qualitative, and not objectively interpreted. There is insufficient evidence in the published scientific literature to determine whether this test impacts treatment decisions or health outcomes in patients with allergies.

Cytotoxic food testing

Also known as Bryan’s Test, the leukocytotoxic test, the leukocytotoxicity test, the leukocytic food allergy test, the cytotoxic leukocyte test, or the CYTOTOXIC test. This test involves the response of specially collected white blood cells to the presence of food extracts to which the patient is allergic.

According to the AAAAI*, and the NCHCT** there is no proof that this testing is clinically effective for foods and pollens. The available scientific evidence does not show these tests are safe and effective.

No specific code.

This testing is also known as electro-acupuncture or the “Magic Eight Ball” and measures changes in the skin resistance while a person is

This testing has yet to be studied and validated and therefore is unproven.

No specific code.

Electrodermal testing

86160* *When used for allergy testing

95199 may be used

The following may be

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Medical Policy: Allergy Testing Original Policy Date: 6/28/2013 Effective Date: 6/28/2013

used:

exposed to an allergen, either food or inhalant. The testing device uses a galvanometer to measure the electrical resistance of the skin. A drop in the resistance of the skin is believed to indicate the presence of allergy.

97813 97814 95199

Hair analysis

A person’s hair is analyzed for mineral content. It is proposed to aid in the evaluation of a person’s general health, diagnose skin diseases, detect allergies, heavy metals and pesticides, identify nutritional deficiencies and the presence of illegal drugs etc.

There is insufficient evidence in the published peer-reviewed literature to support the accuracy and clinical utility of hair analysis for allergy testing.

P2031

IgG/IgG4 allergen specific antibody or food test (serum IgG/IgG4 levels)

There are four subclasses of immunoglobulin G. Selective deficiencies in one or more of the four IgG subclasses are seen in some patients with repeated infections. Measurements of IgG and specifically IgG4 antibodies have been used in research settings as diagnostic and prognostic tests to determine response to allergy treatments.

According to the EAACI*** in 2008: “Food-specific IgG4 does not indicate (imminent) food allergy or intolerance, but rather a physiological response of the immune system after exposition to food components. Therefore, testing of IgG4 to foods is considered as irrelevant for the laboratory work-up of food allergy or intolerance and should not be performed in case of foodrelated complaints.”

86001 82784

In vitro metal allergy testing (also known as lymphocyte transformation tests [LTT])

A blood test that measures cellular immune responses (delayed type hypersensitivity) to metals in in jewelry and dental implants and is proposed for use to test patients who are considering metal orthopedic implants. The Genesis Clinical Laboratory/Orthopedic Analysis is one company that produces commercially available tests.

There is insufficient evidence in the peer-reviewed scientific literature to establish the clinical utility or support the use of this testing in the diagnosis and/or management of allergies.

No specific code.

Iridology

Iridology, also referred to as iris diagnosis, is based on the

According to the AAAAI* and the American College of

No specific code.

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Medical Policy: Allergy Testing Original Policy Date: 6/28/2013 Effective Date: 6/28/2013

belief that each area of the body is represented by a corresponding area in the iris of the eye. It is proposed that a person's state of health and disease can be diagnosed from the color, texture and location of various pigment flecks in the eye.

ACAAI** there is “no evidence of diagnostic validity” of iridology (Bernstein et al., 2008).

99199 may be used.

Leukocyte histamine release testing (LHRT)

An in vitro test that evaluates the presence of specific IgE antibodies. An allergen is added to the peripheral blood leukocytes of the person being tested and the in vitro release of histamine from basophils in response to exposure to the allergen is measured. This test is typically used in research laboratories.

This test is typically used in research laboratories and has not been fully studied for its predictive value in determining specificity and sensitivity. There is insufficient evidence to permit conclusions on the diagnostic accuracy of LHRT.

86343

Lymphocyte Response Assay (LRA)/Lymphocyte Transformation

This test analyzes lymphocytes in a laboratory culture for their reaction to over 300 foods, minerals, preservatives, and other environmental substances. The Biotechnologies website advised that the test provides an “immunologic fingerprint” of delayed reactive substances.

There are no published scientific studies reported in the peer-reviewed literature to demonstrate whether this testing is clinically useful in the diagnosis or management of allergic disease.

86353*

The test is used to identify delayed food allergies and treatment involves dietary manipulation and possibly supplements and/or herbs. It has been primarily proposed for patients with irritable bowel syndrome but is promoted for various other conditions (e.g., migraine, chronic fatigue syndrome, dermatologic conditions, and rheumatologic disorders.

There are no studies of MRT reported in the published peerreviewed scientific literature that demonstrate improved clinical outcomes by incorporating MRT and its associated dietary modifications.

No specific code but being billed as:

This test is based on the theory that allergies are caused by “energy blockage” that can be

This testing has yet to be studied and validated and therefore is unproven.

No specific code.

By ELISA/ACT®

Mediator release test (MRT) Marketed as the Lifestyle Eating and Performance (LEAP) and MRT test

Nambudripad's allergy elimination technique (NAET)

*when used for allergy testing

83516 83520 86256* *Reported; however not correct code for this testing.

95199 may

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Medical Policy: Allergy Testing Original Policy Date: 6/28/2013 Effective Date: 6/28/2013

be used

diagnosed with muscle-testing and permanently cured with acupressure and/or acupuncture treatments. This test is an off-shoot of applied kinesiology. Substances are placed in the patient’s hand and the practitioner tests whether the arm can resisted being pulled by the provider. If the arm is weak, the substance is said to cause allergy.

Nasal challenge test Also known as nasal mucous membrane test; nasal challenge/provocation test, and more commonly the “sniff test”. The test provides precise measurements of changes in nasal airway resistance along with observations such as number of sneezes and measurement of inflammatory mediators in the nasal secretions after exposure to an allergen.

While this test is used in studies of allergic rhinitis, its clinical utility has not been established. Available evidence is in the form of expert opinion rather than studies evaluating the technique. There is insufficient evidence in the peer-reviewed scientific literature to determine whether this test impacts treatment decisions or health outcomes in patients with allergies.

95065

Passive transfer of P-X (PrausnitzKustner test)

Performed by injecting serum intradermally from a suspect allergic patient into a nonallergic patient and later challenging the injection site with antigens.

This test is now considered obsolete and has been replaced by RAST testing.

No specific code.

Provocation neutralization testing

Also referred to as the food additive allergy test, or the Rinkel test. Performed by injecting (intradermal or subcutaneous), or sublingually, dilute extracts of the suspected food or inhalant allergen and observing the patient’s response or reaction. A symptomatic response indicated an allergy to that food or inhalant, and the reaction can be neutralized by an application of similar extract of a lesser dilution. A test of the inflammatory

The American College of Physicians and the AAAAI (2008) consider this testing method unproven. Based on a review of the published peerreviewed scientific literature, provocation-neutralization testing is unproven.

No specific code

Rebuck skin

Unlisted antigen codes that may be used: 86486 95199

This test is not useful in

No specific

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Medical Policy: Allergy Testing Original Policy Date: 6/28/2013 Effective Date: 6/28/2013

window test

process in which the skin is abraded and a cover slip is applied to the abraded area. The cover slips are removed and replaced at intervals and examined for the presence of cells involved in the immune response.

code.

documenting allergies since other immunodeficiencies may be found in patients with allergic conditions. There is insufficient evidence in the published peer-reviewed literature to support the accuracy and clinical utility of the Rebuck skin window test.

Documentation Required for Clinical Review 

History and physical and/or allergy specialist consultation report including:  Medical justification of each specific test requested  Prior treatment and testing  Specific allergens to be tested  Specific test(s) requested and number of tests /pricks/units (as applicable)  Treatment plan

Post Service 

Laboratory reports (specific to allergy testing)

The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illness or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. These Policies are subject to change as new information becomes available.

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