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Allergen Testing
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Defines coverage criteria and limitations for in‑vitro and skin‑based allergen testing, including specific IgE, total IgE, basophil activation testing, proprietary panels, and other ancillary tests for Blue Cross Blue Shield of Louisiana members.
New CC4: 'When performed on the same day as skin prick testing, specific IgE in-vitro allergy testing DOES NOT MEET COVERAGE CRITERIA'.
Added CPT code 95004.
Removed CC1 (clinical guidance only) and associated Note 1 defining contraindications for skin testing.
Client requested variance: Addition of CC2c for individuals with chronic rhinosinusitis with nasal polyps being considered for Xolair therapy.
CC4 added previously stating annual re-testing for same food allergens meets coverage criteria in children/adolescents was edited and CC5 edited for clarity.
Coverage Criteria and Medical Necessity
Covered: Specific IgE in-vitro testing (limited panel)
Covered when ALL of the following are met
Per policy: selection of allergens must be guided by clinical history/exam and environment.
Covered: Total serum IgE
Covered in any of the following situations (OR logic across listed indications)
Listed as discrete indications in policy.
Covered: Monitoring food allergy resolution in children/adolescents
Covered when ALL of the following are met
Applies only to children and adolescents per policy; frequency stated as yearly re‑evaluation in guideline context.
Not Medically Necessary / Not Covered
Listed exclusions due to insufficient evidence or redundancy with skin testing.
Guideline-supported indications and testing pathways
Tests and indications supported by professional guidelines:
Based on AAAAI/ACAAI practice parameters.
AAAI/ACAAI guidance.
AAAI 2020 practice parameter update.
Guideline and evidence summaries (Santos et al., EAACI, NASEM).
JTFPP recommendations.
Covered when clinically indicated
Testing is supported when clinical history and examination indicate probable IgE-mediated disease or suspected contact dermatitis requiring patch testing; specialist-level testing may be appropriate in select scenarios.
Supported by WAO, NIAID, International Consensus.
JTFPP summary statements.
International Consensus, WAO, EAACI guidance.
Coverage and clinical criteria (summary)
Clinical guidance summarized from cited organizations:
NASEM, NICE, AAFP, Royal College summaries.
NASEM and NICE recommendations.
EAACI, NASEM, EAACI Molecular Allergology guidance.
International Consensus Statement and NICE.
Notable Coverage Criteria Updates
Policy-level coverage criteria updates and notable rules from the review history:
New explicit exclusion added in review history.
Former CC2 became CC1 focused on annual number/usage.
Client‑requested variance added in revision.
Referenced as edited CC in review history.
The policy explicitly identifies several nonstandard or qualitative multi‑allergen assays as not meeting coverage criteria due to insufficient evidence of clinical utility. Specifically, the document lists qualitative multi‑allergen screens that do not identify specific allergens, ALCAT (Antigen Leukocyte Antibody Test), and bead‑based epitope assays (for example, VeriMAP) among tests excluded from coverage. These proprietary or broad panel tests are noted for limited reproducibility, lack of correlation with clinical allergy, and insufficient published evidence to support routine clinical use.
The policy states that IgG and IgG subclass antibody tests for food allergy are not clinically relevant and should not be performed. Guideline text cited in the policy indicates these tests are not validated, lack sufficient quality control, and their presence typically reflects prior exposure rather than hypersensitivity, making them unsuitable for diagnosing IgE‑mediated food allergy.
Professional society guidance and the policy discourage routine use of broad specific IgG or indiscriminate IgE food panels. The document notes Choosing Wisely and AAAAI recommendations against performing unproven diagnostic tests or an indiscriminate battery of IgE tests, and emphasizes that specific testing should be guided by the patient’s clinical history and targeted to relevant allergens rather than routine panel screening.
The policy identifies a range of unproven or commercially marketed diagnostic tests that do not meet coverage criteria. Examples called out include the ALCAT (leukocyte stimulation test), various laboratory‑developed multi‑analyte microarrays and panel tests, and other procedures described in the literature as unproven for routine clinical allergy diagnosis. The rationale cites limited reproducibility and insufficient peer‑reviewed evidence supporting clinical benefit.
The policy makes clear that specific IgE in‑vitro allergy testing performed on the same day as skin prick testing DOES NOT MEET COVERAGE CRITERIA. Same‑day in‑vitro testing conducted in conjunction with percutaneous skin testing will be denied under this policy.
Routine repeat testing for the same allergens in the absence of a new clinical presentation is not covered. The policy states that routine re‑testing for the same allergens DOES NOT MEET COVERAGE CRITERIA, with the exception noted elsewhere for annual re‑testing in children and adolescents to monitor food allergy resolution.
The policy and guideline sources recommend against routine or indiscriminate battery testing. Ordering broad, non‑targeted panels without a supporting clinical history is discouraged and may lead to inappropriate diagnoses; testing should be limited to allergens selected on the basis of a focused history, exam, and likely exposures.
Ordering specific IgG testing to food panels or broad, indiscriminate IgE screening without a clinical history indicating likely allergens is considered not medically necessary. Choosing Wisely and specialty guidance emphasize that IgG panels reflect exposure rather than allergy and can result in misdiagnosis and unnecessary interventions.
The policy states that routine use of nonstandardized tests—including many commercial food sensitivity assays and other unvalidated procedures—is not supported. While some assays (for example, basophil activation tests) may have research or specialist roles, the policy identifies functional and proprietary assays without standardized methodology as not meeting coverage criteria for routine clinical diagnosis.
Except for specified exceptions (such as annual pediatric re‑testing to monitor food allergy resolution), the policy reiterates that routine re‑testing for the same allergens DOES NOT MEET COVERAGE CRITERIA. Providers should document a new clinical presentation or other justifying indication before repeating tests for the same allergens.
Procedure Codes and Proprietary Test Codes
| 82784 | Gammaglobulin (immunoglobulin); IgA, IgD, IgG, IgM, each. |
| 82785 | Gammaglobulin (immunoglobulin); IgE. |
| 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, crude allergen extract, each. |
| 86005 | Allergen specific IgE; quantitative or semiquantitative, crude allergen extract, each Allergen specific IgE; qualitative, multiallergen screen (eg, disk, sponge, card). |
| 86008 | Allergen specific IgE; quantitative or semiquantitative, recombinant or purified component, each. |
| 88184 | Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; first marker. |
| 88185 | Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; each additional marker. |
| Proprietary | VeriMAP™ Peanut Dx - Peanut allergen-specific quantitative assessment of multiple epitopes using enzyme-linked immunosorbent assay (ELISA); blood, individual epitope results and probability of peanut allergy (AllerGenis Clinical Laboratory). |
| Proprietary | VeriMAP™ Peanut Sensitivity - Peanut allergen-specific quantitative assessment of multiple epitopes using enzyme-linked immunosorbent assay (ELISA); blood, report of minimum eliciting exposure for a clinical reaction (AllerGenis Clinical Laboratory). |
| 95004 | Added CPT code (policy text indicates CPT 95004 was added) |
| 83520 | Removed (reference: policy notes indicate code 83520 was removed) |
Provider Requirements, Documentation, and Billing Guidance
Prior authorization — none specified
No explicit prior authorization requirements are stated in this excerpt of the policy.
Prior authorization for broad/indiscriminate panels
Broad or indiscriminate multi-allergen panels that are not clinically justified may require additional justification and could be subject to prior authorization per payer processes.
- Policy emphasizes selecting allergens based on history, exam, age, environment, region, occupation, and activities.
- Indiscriminate multi-allergen screens that do not identify specific allergens DO NOT MEET COVERAGE CRITERIA.
Obtain total serum IgE to support biologic dosing (e.g., Xolair)
Measure serum total IgE prior to initiation of certain biologic therapies (example: omalizumab/Xolair) because dosing is determined by pre-treatment total IgE level and body weight.
- Determine dose and dosing frequency by serum total IgE level (IU/mL) measured before the start of treatment per Xolair prescribing information.
- Documented IgE level should be available when seeking authorization for such therapy.
Procedure codes referenced for allergen testing
Use the policy’s listed CPT/HCPCS codes when ordering or billing for allergen testing; these include codes for allergen-specific IgE, immunoassays, flow cytometry markers, and percutaneous skin tests.
CPT update — 95004 added
CPT code 95004 (percutaneous tests with interpretation) was added to the policy; providers should bill using the appropriate CPT codes listed in the policy.
- 95004: Percutaneous tests (scratch, puncture, prick) with allergenic extracts, immediate type reaction, including test interpretation and report; specify number of tests.
Step therapy — none specified
No step therapy requirements are described in this portion of the document.
Two‑step testing approach for peanut — SPT/Ara h 2 then BAT
For suspected peanut allergy, use a staged diagnostic approach: perform skin prick testing (SPT) or component testing (e.g., Ara h 2) first and reserve basophil activation testing (BAT) for equivocal cases or specialist settings.
- BAT may be performed only after equivocal SPT or Ara h 2 sIgE and can markedly reduce the need for oral food challenges.
Provider actions — not specified
Not specified in this excerpt.
Step therapy — not described
No step therapy requirements are specified in this document excerpt.
Limit testing to allergens justified by history/exam/environment
Testing is covered only for allergens chosen based on the individual’s history, physical examination, and environment; document the clinical rationale linking selected allergens to the history and exam.
- Specific IgE in‑vitro testing coverage limited to up to 20 allergen-specific antibodies per year when selection is based on history, exam, and environment.
- Select allergens considering patient age, region, occupation, activities, and prevalence in ambient air.
Document clinical rationale and test selection
Document clinical rationale for test selection: record how history, physical exam, age, environment, region, occupation, and activities informed the allergens and modality chosen (SPT vs serum sIgE).
- When serum sIgE is used instead of skin testing, document the reason (e.g., widespread skin disease, skin‑test suppressive therapy, uncooperative patient, high anaphylaxis risk).
- For food allergy follow-up in children, document rationale for annual re-testing to monitor for resolution when applicable.
Document detailed history, exam, medication review, and clinician competency
Record a detailed allergy-focused history, focused physical examination, and medication review before testing; document that testing and interpretation were performed by clinicians with appropriate competencies and that facility readiness (eg, anaphylaxis management) is available for skin testing.
- NICE: Do not carry out allergy testing without first taking an allergy-focused clinical history and interpret results in that context.
- JTFPP: Complete a detailed history and physical exam for rhinitis and review medications prior to testing.
Required documentation and clinician competencies
Ensure allergy-focused clinical history is documented prior to testing and confirm that the ordering/interpreting clinician has competency in test selection and interpretation.
- Royal College: Only test ASIgE for food when answers to key clinical questions confirm an IgE-mediated mechanism and limit testing to relevant trigger foods.
- Document that testing will affect management (eg, avoidance, immunotherapy referral) as appropriate.
Document indications consistent with updated CCs and CPT updates
Align documentation with updated coverage criteria and CPT changes: when using specific IgE in lieu of skin testing or for pediatric food re-testing, document the indication consistent with the revised CCs.
- New CC4 prohibits same‑day specific IgE in‑vitro testing with skin prick testing — document testing dates to show compliance.
- 95004 was added to the policy; ensure coding in documentation matches the policy codes.
Denial risk — same‑day in‑vitro sIgE with skin prick testing
Specific IgE in‑vitro testing performed on the same day as skin prick testing is excluded from coverage and will be denied.
- Ensure serum testing is not performed the same day as SPT; document dates/times of tests if needed for audit or prior authorization.
Denial risk — routine re‑testing without new clinical presentation
Routine re-testing for the same allergens without a new clinical presentation does not meet coverage and will be denied, except for annual food allergen re‑testing in children/adolescents to monitor for resolution.
- If repeating tests, document new clinical signs/symptoms or explicit pediatric monitoring rationale to support coverage.
- Annual re-testing for food allergen resolution is covered only for children and adolescents with prior positive results.
Denial risk — unproven or indiscriminate testing (IgG, ALCAT, broad panels)
Ordering indiscriminate battery testing or unproven tests (e.g., IgG food panels, ALCAT, bead‑based epitope assays) is discouraged by professional societies and may be denied as not meeting coverage criteria.
- ALCAT and bead‑based epitope assays (eg, VeriMAP) DO NOT MEET COVERAGE CRITERIA.
- IgG and IgG subclass antibody tests for food allergy lack validation and should not be performed.
Denial risk — testing for not‑routinely‑indicated indications
Do not order skin prick testing or serum testing for indications explicitly listed as not routinely indicated (eg, specific IgG panels for food, suspected food intolerance without allergic features, chronic urticaria without allergic history, or screening asymptomatic individuals) because such orders may be denied.
- WOA and other guidelines list multiple not‑routinely‑indicated scenarios where testing is not supported.
- Document the presence of allergic features if testing is pursued in borderline cases.
Denial risk — lack of allergy‑focused history and contextual interpretation
Always obtain and document an allergy‑focused clinical history prior to testing and interpret results in that context; failure to do so may trigger denial risk.
- NICE: Do not carry out allergy testing without first taking an allergy‑focused clinical history and interpret test results in that context.
- JTFPP: Complete a detailed history, exam, and medication review to support indications for testing.
Same‑day testing denial risk — separate testing days required
Perform in‑vitro specific IgE testing and skin prick testing on separate days; same‑day testing will trigger non‑coverage.
- Document the dates of SPT and in‑vitro testing to demonstrate they were not performed the same day.
- If both modalities are clinically necessary, schedule them on different days and record the clinical justification.
Background, Definitions, and Test Descriptions
Allergic disease represents inappropriate immune responses, most commonly IgE‑mediated (Type I) hypersensitivity, or less commonly T cell‑mediated (Type IV) reactions. Accurate diagnosis requires identification of the suspected allergen, demonstration of specific IgE or other relevant immune markers, and correlation of test results with the clinical history. The policy highlights that skin prick testing (SPT) is rapid and widely used, whereas in‑vitro specific IgE testing is an alternative when skin testing is unsafe or impractical; testing choice and interpretation must be grounded in an allergy‑focused history and physical examination.
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