Allergy Testing, Including Selected Blood, Serum and Cellular Testing and Toxicity Testing Corporate Medical Policy
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This policy governs coverage of specified allergy tests and selected blood, serum, cellular, and toxicity-related tests. Covered testing must meet stated medical-necessity criteria; other identified tests are not medically necessary or investigational.
Medical-necessity criteria for KIT D816V mutational analysis to aid diagnosis of suspected systemic mastocytosis were added.
CPT 82787 was changed to investigational for food sensitivity or allergy testing.
CPT 83516 was changed to investigational when specified as ALCAT testing.
CPT 86160 was changed to investigational for all diagnoses except potential use in autoimmune disorders, complement component deficiencies, hereditary angioedema, and vasculitis.
Medical Necessity and Coverage Criteria
Eligible allergy testing services
The following allergy testing may be considered medically necessary:
Covered allergy testing categories
- Epicutaneous or intradermal testing for IgE-mediated reactions to inhalants, foods, Hymenoptera, or specified drugs, including penicillins and macromolecular agents.
- Patch testing for contact allergic dermatitis or certain drug-induced cutaneous reactions.
- Photo patch testing for photoallergy or photosensitization, such as photoallergic contact dermatitis.
- Ingestion oral double-blind challenge testing for suspected IgE-mediated hypersensitivity when history and physical findings are suggestive but skin testing is negative or equivocal.
- Drug provocation or challenge testing meeting the separate drug-challenge criteria.
- Bronchial challenge testing meeting at least one qualifying indication.
- Exercise challenge testing for exercise-induced bronchospasm.
- Skin Endpoint Titration to determine the starting dose for immunotherapy in members highly allergic to inhalants or Hymenoptera venom.
Drug provocation or challenge testing
Drug provocation or challenge testing is medically necessary when ALL of the following are met:
Drug provocation or challenge requirements
- The member has a history of allergy to the particular drug.
- Treatment with that drug class is essential.
- No effective alternative drug is available.
Bronchial challenge testing
Bronchial challenge testing with methacholine, histamine, or antigens is medically necessary when ANY of the following apply:
Qualifying bronchial challenge indications
- The test identifies causative or provocative occupational or other allergens for which skin testing is not reliable.
- The test confirms asthma when the member is symptomatic, pulmonary function test results are abnormal, and there is no response to a bronchodilator.
- The test evaluates new allergens or substantiates the role of allergens in a member with significant symptoms.
- The test evaluates occupational asthma.
Allergen-specific IgE immunoassays
Allergen-specific IgE immunoassays may be medically necessary for inhalant or food allergy when percutaneous testing cannot be performed due to ANY of the following:
Qualifying reasons for in vitro IgE testing
- Severe dermatographism, ichthyosis, or generalized atopic dermatitis.
- Long-acting antihistamines, tricyclic antidepressants, or other medications that may create undue risk if discontinued.
- The member is uncooperative because of mental or physical impairment.
- An infant or child will not tolerate skin testing, or severe reaction to skin testing is a concern.
- Serial testing of a child with documented food allergy is needed to assess whether an oral food challenge may occur.
- The test is an adjunctive laboratory test for disease activity in allergic bronchopulmonary aspergillosis or certain parasitic diseases.
- The test evaluates cross-reactivity between insect venoms.
- Clinical history suggests an unusually high risk of anaphylaxis from skin testing, including when an unusual allergen is unavailable as a licensed skin-test extract.
- Direct skin testing is inconclusive.
Lymphocyte transformation testing
Lymphocyte transformation testing may be medically necessary for ANY of the following:
Qualifying lymphocyte transformation indications
- Medical surveillance of beryllium sensitivity and chronic beryllium disease.
- Evaluation of suspected congenital or acquired immunodeficiency diseases affecting cell-mediated immunity.
- Prediction of allograft compatibility in the transplant setting.
Total serum IgE
Total serum IgE may be medically necessary for diagnostic evaluation of members with known or suspected ANY of the following:
Qualifying total serum IgE indications
- Allergic bronchopulmonary aspergillosis.
- Certain stages of HIV infection.
- Drug-induced interstitial nephritis.
- Eczema and hyper-IgE syndrome, including dermatitis and recurrent pyogenic infections.
- Graft-versus-host disease.
- Parasitic diseases.
- Selected immune deficiency diseases, including Wiskott-Aldrich syndrome and IgE myeloma.
Complement antigen testing
Complement antigen testing may be medically necessary for ANY of the following qualifying disorders:
Qualifying complement antigen testing indications
- An autoimmune disorder.
- A complement component deficiency.
- Hereditary angioedema.
- Vasculitis.
KIT D816V mutational analysis
Mutational analysis of KIT D816V may be medically necessary when ALL of the following apply:
KIT D816V indication
- The member has symptoms compatible with suspected systemic mastocytosis.
- The test is used to aid diagnosis of suspected systemic mastocytosis.
Investigational allergy and toxicity testing
The following allergy testing is unproven and therefore investigational; the list may not be all-inclusive.
Investigational or unproven testing
- Advanced cell testing, adrenal stress index, alpha-gal allergy testing, anti-Fc epsilon receptor antibody testing, ALCAT, applied kinesiology, basophil testing, basophil histamine release assay, body chemical analysis, Candida hypersensitivity testing, chemical analysis of body tissues such as hair, or chlorinated pesticide testing.
- Circulating immune-complex testing for foods, component-resolved diagnostics, conjunctival challenge testing, cytokine or cytokine-receptor assays, cytotoxic food testing, electrodermal diagnostic testing, electrodermal acupuncture, eosinophil cationic protein testing, Food Immune Complex Assay, hair analysis, or HEMOCODE Food Intolerance System.
- Immunoglobulin G food-sensitivity or allergy testing, iridology, kinesiology or applied kinesiology, leukocyte histamine release testing, lymphocyte function assay, mediator release testing, or muscle-strength testing after allergen ingestion.
- Nasal mucous membrane challenge testing, passive transfer or Prausnitz-Kustner testing, provocation-neutralization testing, pulse or reaginic pulse testing, Rebuck skin-window testing, SAGE testing, saliva testing, serum IgG or IgG4 antibody testing, or Rinkel skin titration.
- Sublingual provocative neutralization testing or treatment with hormones, urine autoinjection or autogenous urine immunization, venom-blocking antibody testing, or volatile chemical panels.
- Laboratory testing for electromagnetic sensitivity syndrome or disorder, multiple chemical sensitivity syndrome, or idiopathic environmental intolerance, including testing designed to affirm idiopathic environmental intolerance.
- Treatments for idiopathic environmental intolerance, including IVIG, neutralizing therapy with chemical or food extracts, avoidance therapy, elimination diets, or oral nystatin.
CPT 86160 clinical exceptions
CPT 86160 is investigational for all diagnoses except when it may be indicated for ANY of the following conditions:
Specified clinical exceptions
- An autoimmune disorder.
- A complement component deficiency.
- Hereditary angioedema.
- Vasculitis.
Testing designed to affirm idiopathic environmental intolerance, including laboratory testing for multiple chemical sensitivity or related environmental illness, is investigational. Treatments for this condition, including IVIG, neutralizing therapy using chemical or food extracts, avoidance therapy, elimination diets, and oral nystatin, are also investigational.
Specific IgG antibody testing by RAST or ELISA is excluded from useful diagnosis or treatment of allergic disease when there is no suspected immunodeficiency. Low-level food-specific IgG antibodies commonly circulate without known pathogenic significance, and the policy states that specific IgG antibody testing has no diagnostic value for atopic disease.
CPT 83516 is considered investigational when the service is specified as ALCAT testing.
CPT 82787, immunoglobulin subclass testing, is considered investigational when used for food sensitivity or allergy testing.
The Leukocyte Histamine Release Test (LHRT) is considered not medically necessary.
The policy states that routine allergy retesting that will not change clinical management is considered medically necessary.
Routine IgG-mediated food sensitivity testing has no established diagnostic value for atopic or allergic disease. Low-level food-specific IgG antibodies commonly circulate without known pathogenic significance, and there is insufficient evidence to support specific IgG antibody testing for diagnosing or treating allergic disease without suspected immunodeficiency.
Routine quantitative measurement of total serum IgG, IgA, and IgM is not typically clinically useful in diagnosing or managing allergic disease because their levels are not altered by allergic diseases. The role of routine measurement in allergic disease has not been established.
Total serum IgE testing generally provides no additional diagnostic information when clinical signs of allergic disease are evident, and normal IgE levels do not exclude allergic disease in infants or children. Testing may be indicated for selected conditions, including suspected allergic bronchopulmonary aspergillosis, hyper-IgE syndromes, certain stages of HIV infection, IgE myeloma, drug-induced interstitial nephritis, graft-versus-host disease, parasitic diseases, and specific immune deficiency diseases.
CPT Coding and Coverage Status
| 81273 | KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (e.g., mastocytosis), gene analysis, D816 variant(s). |
| 82787 | Immunoglobulin subclasses (e.g., IgG1,2, 3, or 4. |
| 83516 | Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method [When specified as ALCAT]. |
| 86001 | Allergen specific IgG quantitative or semiquantitative, each allergen. |
| 86160 | Complement; antigen, each component. |
| 86343 | Leukocyte histamine release test (LHR). |
| 95199 | Unlisted allergy/clinical immunologic service or procedure [when specified as cytotoxic testing for allergies]. |
Authorization, Documentation, and Denial Risks
Prior Approval Required for KIT Analysis
Prior approval is required before billing CPT 81273 for KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) gene analysis of D816 variant(s), including analysis used in suspected systemic mastocytosis.
- CPT 81273: KIT D816 variant analysis
- Policy instruction: Prior Approval Required
Maintain Records for Audit
Maintain complete records supporting compliance with this medical policy and the medical necessity of billed services. Records should be available for Blue Cross VT review or audit.
- Retain clinical documentation, test indications, results, and billing support
- Documentation may be requested during a provider or facility audit
Medical Records Required for CPT 95199
Claims for CPT 95199 when specified as cytotoxic allergy testing will suspend for medical-record review. Submit records sufficient to identify the service, clinical indication, and supporting medical necessity.
- CPT 95199: unlisted allergy/clinical immunologic service or procedure when specified as cytotoxic testing
- Medical records are required when the claim suspends for review
Unsupported block type: denial_risk
Unsupported block type: denial_risk
Document Why Skin Testing Cannot Be Performed
Allergen-specific in vitro IgE testing is covered when percutaneous testing cannot be performed for a qualifying reason. Document the specific limitation or clinical circumstance supporting use of the blood test.
- Severe dermatographism, ichthyosis, or generalized atopic dermatitis
- Medications that cannot be safely discontinued, including long-acting antihistamines or tricyclic antidepressants
- Uncooperative members, infants, or children unable to tolerate skin testing
- Concern for severe reaction, unusually high anaphylaxis risk, or unavailable licensed skin-test extract
- Serial food-allergy testing to assess whether an oral food challenge may occur
- Direct skin testing is inconclusive; adjunctive testing for specified diseases; or evaluation of insect-venom cross-reactivity
Routine Skin Endpoint Titration Not Covered
Do not use Skin Endpoint Titration (SET) as routine allergy testing. The policy limits SET to determining the starting immunotherapy dose for members highly allergic to an inhalant allergen or Hymenoptera venom.
- Covered purpose: starting-dose determination for immunotherapy
- Qualifying allergy: inhalant allergy or Hymenoptera venom allergy
- Routine testing is not appropriate
Noncovered or Investigational Testing
The policy classifies certain allergy and cellular testing services as not medically necessary or investigational. Verify coverage before ordering or billing these services, and do not represent investigational testing as covered allergy evaluation.
- Leukocyte Histamine Release Test (LHRT) is not medically necessary
- Examples of investigational services include cytotoxic food testing, ALCAT, basophil tests, component-resolved diagnostics, conjunctival challenge testing, IgG food sensitivity testing, mediator release testing, provocation-neutralization testing, and hair or saliva testing
- Additional investigational categories include electrodermal testing, kinesiology, nasal mucous membrane challenge testing, venom-blocking antibodies, and testing for electromagnetic or idiopathic environmental intolerance
Investigational or Noncovered Testing
Testing classified as investigational or not medically necessary is subject to denial. In particular, IgG-mediated food-sensitivity testing lacks demonstrated diagnostic value for atopic disease, and the coding table identifies several related services as investigational or noncovered.
- CPT 82787: investigational in food sensitivity/allergy testing
- CPT 83516 when specified as ALCAT: investigational
- CPT 86001: not medically necessary for all diagnoses
- CPT 86160: investigational except it may be indicated for autoimmune disorders, complement component deficiencies, hereditary angioedema, and vasculitis
Cytotoxic Testing Review
Cytotoxic allergy testing billed under CPT 95199 is not medically necessary for all diagnoses and is subject to medical-record review. Claims may suspend while Blue Cross VT evaluates the submitted documentation.
- CPT 95199: unlisted allergy/clinical immunologic service or procedure when specified as cytotoxic testing
- The code-table status is not medically necessary for all diagnoses
- Provide records promptly when the claim is suspended
Audit and Recoupment
Blue Cross VT may audit any provider or facility for compliance with the medical policy. If an audit identifies noncompliant payments, Blue Cross VT reserves the right to recoup those payments.
- Audit authority applies to providers and facilities
- Noncompliant payments may be recouped
Clinical Background
Allergy testing helps identify allergens responsible for allergic reactions. Responses may involve IgE-mediated allergy, contact hypersensitivity, airway hyperreactivity, or other immune mechanisms. Food allergy is generally an IgE-mediated reaction to a specific protein and may range from mild symptoms to anaphylaxis, whereas food intolerance is generally nonimmune and may cause nonspecific chronic symptoms.
Key Definitions
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