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    v1.0.31
    OpenPayerPolicy UpdatesAllergy/Clinical ImmunologyCigna Allergy Testing Coverage Update | OpenPayer
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    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    ModifiedCignaPolicy 0070

    Allergy Testing and Non-Pharmacologic Treatment

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    Defines medical necessity, frequency limits, and coverage stance for in vivo and in vitro allergy testing and non-pharmacologic immunotherapy (subcutaneous and sublingual) for members under Cigna-administered benefit plans.

    Policy Summary
    PayerCigna
    PolicyAllergy Testing and Non-Pharmacologic Treatment
    Policy CodePolicy 0070
    Change TypeAdded testing limitsremoved select in vitro test coverage statements
    Effective DateApr 15, 2025
    Last ReviewApr 15, 2026
    Next Review DateApr 15, 2026
    Key ActionDocument testing indications and obtain prior authorization when services approach or exceed stated frequency or dose limits (e.g., CPT 95004, 95024, 86003, 95165).
    SourceLink
    POLICY UPDATE CHANGES

    Policy statements related to in vitro metal LTT for joint replacement surgery and LHR in vitro allergy testing were removed.

    Policy statements regarding testing limits on allergy testing and preparation of allergen immunotherapy were added.

    The not medically necessary policy statement for in vitro allergy testing and subcutaneous allergen immunotherapy was removed.

    The experimental/investigational or unproven policy statement for allergy testing was updated.

    80max percutaneous tests /12 mo
    40max intracutaneous tests /12 mo
    80max specific IgE tests /12 mo
    150max supervised doses /yr (95165)
    3-5 yrsrecommended maintenance
    LTT & LHRremoved tests

    Coverage Criteria

    Medically Necessary Testing

    Covered when listed conditions apply:

    In vivo tests considered medically necessary: Includes prick/puncture (percutaneous) testing for suspected IgE-mediated hypersensitivity to inhalants, foods, hymenoptera, drugs and/or chemicals; intradermal (intracutaneous) testing for suspected IgE-mediated hypersensitivity to inhalants, hymenoptera, drugs and/or chemicals; skin patch testing for suspected contact allergic dermatitis; photo patch testing for suspected contact photosensitization; skin patch testing performed prior to joint replacement when there is prior implant surgery with complications suspected to be caused by metal allergy or history of severe localized or systemic cutaneous reaction to metals; skin patch testing performed after joint replacement when symptoms attributable to metal allergy/hypersensitivity are present and non‑allergic etiologies (infection, mechanical failure) have been ruled out; food/food additive double‑blind ingestion challenge when skin testing is negative or equivocal but history suggests IgE‑mediated hypersensitivity; drug provocation/bronchial challenge when there is a confirmed history of drug allergy, the specific drug is required for treatment, no effective alternative exists; and skin serial endpoint titration (SET) when a safe starting dose must be determined because of risk for severe systemic reaction (e.g., bee venom).see coding thresholds

    Frequency limits apply

    In vitro tests considered medically necessary:
    Policy Summary
    PayerCigna
    PolicyAllergy Testing and Non-Pharmacologic Treatment
    Policy CodePolicy 0070
    Change TypeAdded testing limitsremoved select in vitro test coverage statements
    Effective DateApr 15, 2025
    Last ReviewApr 15, 2026
    Next Review DateApr 15, 2026
    Key ActionDocument testing indications and obtain prior authorization when services approach or exceed stated frequency or dose limits (e.g., CPT 95004, 95024, 86003, 95165).
    SourceLink
    On This Page
    Coverage CriteriaCodingProvider Actions & Operational NotesBackgroundDefinitionsRevision History
    Allergen specific IgE and other in vitro assays (e.g., ImmunoCAP/RAST/ELISA) are medically necessary for individuals with severe dermatographism, ichthyosis or generalized eczema; those who cannot discontinue medications that interfere with skin testing (e.g., long‑acting antihistamines, tricyclic antidepressants); those with prior systemic reaction to skin testing; when skin testing is equivocal/inconclusive and confirmatory in vitro testing is required; as an alternative to skin testing for insect venom cross‑reactivity; and as adjunctive testing for allergic bronchopulmonary aspergillosis or certain parasitic diseases.
    see coding thresholds

    Frequency limits apply

    Allergen Immunotherapy

    Covered or not covered immunotherapy:

    Subcutaneous allergen immunotherapy: Considered medically necessary for treatment of allergic asthma and allergic rhinitis (with or without allergic conjunctivitis).professional services CPT 95165 <=150 doses/year

    Preparation/supervision doses above this limit are not covered or reimbursable

    Sublingual antigen extract drop immunotherapy preparations (non‑FDA‑approved liquid drops) are not covered or reimbursable; FDA‑approved sublingual products are managed under separate drug/biologic policies (see related policies).N/A

    Refer to pharmacy/drug coverage policies for approved SLIT products

    Subcutaneous Allergen Immunotherapy (SCIT)

    Covered when ALL of the following are met

    Indications for SCIT: Patient has allergic rhinitis, allergic conjunctivitis, allergic asthma with natural allergen exposure, or stinging insect (Hymenoptera) venom hypersensitivity; symptoms persist despite a period of pharmacologic management and observation; specific IgE antibodies to the relevant allergen(s) are demonstrated by skin testing or in‑vitro testing; and patient‑level factors (severity/duration of symptoms, patient preference, adherence, medication requirements, response to avoidance measures) have been considered.

    Based on AAAAI/ACAAI practice parameters

    Immunotherapy schedule and duration: Standard SCIT includes an initial build‑up phase (often 1–3 injections per week) to reach maintenance over ~3–6 months, followed by maintenance injections at progressively increased intervals (up to 4 weeks for inhalant allergens and up to 8 weeks for venom); maintenance therapy is generally continued for 3–5 years for optimal benefit.3-5 years

    Adjust for missed visits, seasons, new allergens, or systemic reactions as clinically indicated.

    Accelerated Immunotherapy Schedules

    Covered with caution

    ref":"b0_3","title":"Accelerated Immunotherapy Schedules"},{
    citations":["32","33"],"intro":"Contested/limited evidence","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"Sublingual liquid antigen extract drops\",\"text\":\"Standardized and non‑standardized sublingual antigen extract liquid drop immunotherapy preparations have mixed and limited evidence; no FDA‑approved liquid drop preparations exist in the U.S., and professional societies do not endorse off‑label liquid drop formulations for routine use.\",\"threshold\":\"\",\"note\":\"SLIT tablet products may be covered under separate pharmacy/drug policies; off‑label liquid drops are not endorsed and require strong justification if proposed.\",\"children\":[]}"] ,"ref":"b0_4","title":"Sublingual Antigen Extract Drop Immunotherapy"},{
    citations":["22","23","24","25"],"intro":"When testing for metal allergy related to implants may be considered","nodes":["{\"operator\":\"any\",\"n\":0,\"label\":\"Metal allergy testing for arthroplasty patients\",\"text\":\"Routine preoperative metal allergy testing prior to joint implantation is not established and is not recommended. Consider patch testing or in vitro testing only for patients with a history of severe localized (e.g., blistering, hives, extensive rash) or systemic cutaneous reactions to metals, or for patients with prior implant complications suspected to be caused by metal allergy after excluding infection and mechanical failure. Positive testing may guide avoidance of specific metals when clinically relevant.\",\"threshold\":\"\",\"note\":\"Testing has limited predictive value for implant outcomes in the general population; document exclusion of other etiologies before attributing symptoms to metal allergy.\",\"children\":[]}"] ,"ref":"b0_5","title":"Metal Allergy/Hypersensitivity Testing for Arthroplasty"},{
    citations":["26","27"],"intro":"Experimental / insufficient evidence","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"Bead‑Based Epitope Assay (BBEA) for food allergy\",\"text\":\"Bead‑based epitope assays (BBEA) measure IgE/IgG4 reactivity to discrete allergen epitopes and have been proposed for diagnosis and monitoring of food allergies; however, published evidence is limited to cohort and comparative case‑control studies with small sample sizes and lacks rigorous trials demonstrating improved clinical outcomes versus existing modalities. BBEA is considered investigational/experimental pending stronger outcome data.\",\"threshold\":\"\",\"note\":\"Not covered until sufficient evidence of clinical benefit is available.\",\"children\":[]}"] ,"ref":"b0_6","title":"Bead-Based Epitope Assay (BBEA)"},{
    citations":["42","46"],"intro":"Testing and treatment considered medically necessary when applicable policy criteria are met","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"General medical necessity\",\"text\":\"Diagnostic testing (in vivo skin tests, in vitro specific IgE assays, challenge testing) and treatment (professional allergen immunotherapy services) are considered medically necessary when the specific clinical criteria in the applicable policy statements are met.\",\"threshold\":\"\",\"note\":\"Refer to the detailed policy statements above for condition‑specific criteria and to coding thresholds for frequency/dose limits.\",\"children\":[]}"] ,"ref":"b0_7","title":"Medical necessity — Testing and Treatment"}]})}}reamble malformed due to assistant output error. Please fix.

    Bead-based epitope assays (BBEA) such as VeriMAP™ Peanut Dx and VeriMAP™ Peanut Sensitivity are classified as not covered or reimbursable due to insufficient evidence demonstrating improved clinical outcomes compared with existing diagnostic modalities. Similarly, sublingual antigen extract liquid drop immunotherapy preparations (non‑tablet liquid drops) are not covered or reimbursable; FDA‑approved sublingual products are handled under separate drug/biologic policies. Providers should reference the related drug/biologic policies for FDA‑approved sublingual therapies.

    Allergen immunotherapy (including subcutaneous immunotherapy) is supported for allergic rhinitis, allergic conjunctivitis, allergic asthma with natural allergen exposure, and stinging insect venom hypersensitivity when clinical criteria are met. However, immunotherapy is not supported for the treatment of angioedema, atopic dermatitis, chronic urticaria, or food hypersensitivity based on current clinical studies and guideline recommendations.

    Use of non‑FDA approved sublingual liquid drop preparations is explicitly not endorsed and is not recommended for routine use in U.S. practice. Professional society guidance notes limited rigorous evidence and discourages off‑label use of liquid drop preparations for current indications; at present there are no FDA‑approved liquid sublingual drop formulations.

    Specific multi‑epitope peanut ELISA tests (HCPCS codes 0165U and 0178U) are listed as not covered or reimbursable. Additionally, supervision and reporting codes used to bill for sublingual antigen extract drop preparations (95165 and 95199) are not covered when used for that purpose; providers should not bill these codes for non‑covered sublingual drop immunotherapy.

    Policy statements related to in vitro metal lymphocyte transformation testing (LTT) for joint replacement surgery and LHR in vitro allergy testing were removed from this Coverage Policy. The revisions note that prior statements about these specific in vitro tests are no longer present in the policy and that providers should not rely on the removed language for current coverage assumptions.

    Frequency limits apply to allergy testing: percutaneous (CPT 95004) tests up to 80 units per rolling 12 months, intracutaneous/intradermal (CPT 95024) tests up to 40 units per rolling 12 months, and allergen specific IgE testing (CPT 86003) up to 80 units per rolling 12 months. Tests that exceed these stated limits are not covered or reimbursable.

    In vitro allergy testing is not indicated when there are no contraindications to skin testing. It is also not indicated for patients who are successfully controlled on therapy for their relevant allergies, have only mild symptoms, and experience a short allergy season. Providers should use in vitro assays primarily when skin testing is contraindicated, inconclusive, or otherwise not feasible.

    The professional supervision code 95165 is subject to an annual limit: supervision of allergen immunotherapy preparation that exceeds 150 doses per rolling 12 months is not covered or reimbursable. Furthermore, use of 95165 and 95199 to report preparation or supervision of sublingual antigen extract drop immunotherapy preparations is not covered or reimbursable.

    A prior policy statement that labeled certain in vitro allergy testing and subcutaneous allergen immunotherapy as 'not medically necessary' has been removed. The policy revisions clarify current coverage language and update experimental/investigational statements, so providers should rely on the current policy criteria for medical necessity determinations.

    Coding

    Covered CPT Codes with frequency/dose limitsCPTCovered
    95004Percutaneous (scratch, puncture, prick) testing
    95024Intracutaneous (intradermal) testing
    86003Allergen specific IgE; quantitative or semiquantitative testing
    95165Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy, single or multiple antigens
    Not covered / investigational tests and proceduresmixedNot Covered
    N/ABead-based epitope assays (e.g., VeriMAP™ Peanut Dx/Sensitivity) — not covered
    Covered Testing CPT/HCPCS CodesCPTCovered
    86003Allergen specific IgE; quantitative or semiquantitative, crude allergen extract, each
    86005Allergen specific IgE; qualitative, multiallergen screen (eg, disk, sponge, card)
    86008Allergen specific IgE; quantitative or semiquantitative, recombinant or purified component, each
    95004Percutaneous tests (scratch, puncture, prick) with allergenic extracts, immediate type reaction, including test interpretation and report, specify number of tests
    95017Allergy testing, any combination of percutaneous and intracutaneous, with venoms, immediate type reaction, including test interpretation and report, specify number of tests
    95018Allergy testing, any combination of percutaneous and intracutaneous, with drugs or biologicals, immediate type reaction, including test interpretation and report, specify number of tests
    95024Intracutaneous (intradermal) tests with allergenic extracts, immediate type reaction, including test interpretation and report, specify number of tests
    95027Intracutaneous tests, sequential and incremental, with allergenic extracts for airborne allergens, immediate type reaction, including test interpretation and report, specify number of tests
    95028Intracutaneous tests with allergenic extracts, delayed type reaction, including reading, specify number of tests
    95044Patch or application test(s) (specify number of tests)
    1–10 of 14
    1/2
    Covered Treatment/Immunotherapy CodesCPTCovered
    95115Professional services for allergen immunotherapy not including provision of allergenic extracts; single injection
    95117Professional services for allergen immunotherapy not including provision of allergenic extracts; 2 or more injections
    95120Professional services for allergen immunotherapy including provision of allergenic extract; single injection
    95125Professional services for allergen immunotherapy including provision of allergenic extract; 2 or more injections
    95144Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy, single dose vial(s)
    95165Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses)
    Not Covered or Reimbursable — Specific TestsHCPCSNot Covered
    0165UPeanut allergen-specific quantitative assessment of multiple epitopes using ELISA, blood, individual epitope results and probability of peanut allergy
    0178UPeanut allergen-specific quantitative assessment of multiple epitopes using ELISA, blood, report of minimum eliciting exposure for a clinical reaction
    Not Covered or Reimbursable — Sublingual preparationsCPTNot Covered
    95165Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses)
    95199Unlisted allergy/clinical immunologic service or procedure
    Percutaneous skin tests (CPT 95004)
    CodeCPT 95004 (percutaneous/scratch/puncture/prick testing)
    LimitUp to 80 test units per rolling 12 months
    Not covered if exceededPercutaneous testing >80 units per rolling 12 months is not covered or reimbursable
    Intracutaneous/intradermal tests (CPT 95024)
    CodeCPT 95024 (intracutaneous/intradermal testing)
    LimitUp to 40 test units per rolling 12 months
    Not covered if exceededIntracutaneous testing >40 units per rolling 12 months is not covered or reimbursable
    Allergen specific IgE tests (CPT 86003)
    CodeCPT 86003 (allergen specific IgE; quantitative or semiquantitative)
    LimitUp to 80 tests per rolling 12 months
    Not covered if exceededAllergen specific IgE testing >80 units per rolling 12 months is not covered or reimbursable
    Professional supervision of immunotherapy preparation (CPT 95165)
    CodeCPT 95165 (professional supervision of immunotherapy preparation)
    LimitUp to 150 supervised doses per 12 months (rolling 12 months)
    Not covered if exceededProfessional services for supervision exceeding 150 doses per rolling 12 months are not covered or reimbursable
    Maximum supervised antigen doses per year
    MetricMaximum supervised antigen doses per year
    Value150 doses per rolling 12 months
    Policy implicationReporting supervision (95165) beyond 150 doses per rolling 12 months is not covered or reimbursable; 95165/95199 used to report sublingual liquid drop preparations are not covered

    Provider Actions & Operational Notes

    Documentation Required

    Coverage determinations require consideration

    When making coverage determinations and submitting claims, confirm the applicable benefit plan, laws/regulations, and any relevant collateral materials (e.g., Coverage Policies, delegated vendor guidelines). Benefits are ultimately determined by the terms of the member's benefit plan in effect on the date of service; coverage requests should be reviewed on their individual clinical merits.

    • Coverage determinations require consideration of: applicable benefit plan document, applicable laws/regulations, and relevant collateral materials (Coverage Policies, delegated guidelines).
    Documentation Required

    Documentation should include clinical history and rationale

    Document clinical history supporting the indication for provocation/challenge testing and for serial endpoint titration (SET) when used. For SET and other specialized testing or preparations, include rationale for testing method, history of prior testing and results, reasons why standard testing is not appropriate or is equivocal, and evidence of potential for severe reaction (e.g., prior systemic reaction) when relevant.

    • Documentation should include clinical history, prior test results, and rationale for SET or provocation/challenge testing.
    • When SET is used to guide immunotherapy starting doses, document why SET is indicated (e.g., risk of severe systemic reaction).
    Documentation Required

    Documentation for testing limits and immunotherapy preparation

    Providers must document indications for in vivo and in vitro testing and justify any testing or immunotherapy preparation that exceeds stated limits. Maintain clear records of symptom persistence, prior pharmacologic management and response, adherence, and reason for selecting SCIT over other therapies. For testing limits or non‑standard immunotherapy preparations, include the clinical justification to support prior authorization when requested.

    • Documentation for testing limits and immunotherapy preparation should include clinical justification, prior management, and symptom persistence.
    • SCIT is usually recommended after a period of pharmacologic management; document prior medication trials and outcomes.
    Billing Rule

    Frequency / dose limits and potential need for authorization

    Frequency and dose limits apply to in vivo and in vitro allergy testing and to professional immunotherapy preparation services; claims exceeding limits may be denied or require prior authorization. Reported counts are evaluated on a rolling 12‑month basis.

    • Percutaneous testing (CPT 95004): limit 80 units per rolling 12 months.
    • Intradermal testing (CPT 95024): limit 40 units per rolling 12 months.
    • Allergen specific IgE testing (CPT 86003): limit 80 units per rolling 12 months.
    • Professional supervision/preparation (CPT 95165): maximum 150 doses per rolling 12 months; units/doses reported beyond these limits are not covered/reimbursable.
    Prior Authorization

    Prior authorization considerations for accelerated schedules and non‑standard SLIT drops

    Prior authorization may be required for accelerated immunotherapy schedules (cluster/rush) and for non‑standard or non‑FDA sublingual liquid/drop preparations due to higher risk of systemic reactions or lack of standardized dosing. Provide clinical justification when requesting accelerated schedules (e.g., rapid need to achieve maintenance dose, documented intolerance of conventional build‑up) and document safety monitoring plans.

    • Accelerated schedules (cluster, rush) carry higher risk of systemic reactions; justify safety need for accelerated approach.
    • Non‑standard SLIT drops (non‑FDA standardized sublingual liquid drops) lack established dosing; prior authorization should include rationale and supporting literature when available.
    Billing Rule

    Prior authorization — immunotherapy professional services

    Professional services and supervision codes for immunotherapy (e.g., CPT 95115, 95117, 95120, 95125, 95144, 95165) are considered medically necessary when criteria are met. Note specific billing limits and denials: CPT 95165 supervision/preparation that exceeds 150 doses per rolling 12 months is not covered; CPT 95165 and 95199 are not covered when used to report sublingual antigen extract drop immunotherapy preparations.

    • 95115, 95117, 95120, 95125, 95144, 95165 are professional service codes related to immunotherapy supervision and administration.
    • 95165 supervision/preparation >150 doses per rolling 12 months = not covered/reimbursable.
    • 95165 and 95199 are not covered/reimbursable when used to report sublingual antigen extract drop immunotherapy preparations.
    Denial Risk

    Claims submitted without covered diagnosis or procedure codes will be denied

    Claims submitted without covered diagnosis or procedure codes will be denied as not covered. Use the most appropriate and current codes as of the date of service and ensure submitted codes align with the applicable Coverage Policy and benefit plan.

    • Claims lacking covered diagnosis/procedure codes under the applicable policy will be denied.
    • Use current AMA/CMS codes; deleted or inactive codes may not be eligible for reimbursement.
    Documentation Required

    Routine metal allergy testing prior to joint implantation

    Routine pre‑operative metal allergy testing prior to joint implantation is not established as clinically beneficial and is not routinely recommended. Consider in vitro or patch testing only with pertinent clinical history (e.g., prior severe localized or systemic reactions to metal, prior implant complications suspected to be due to metal hypersensitivity).

    • Do not perform routine metal allergy testing prior to joint implantation without relevant clinical history.
    • Consider testing only for patients with history of severe cutaneous/systemic reactions or prior implant complications suspected due to metal allergy.
    Note

    Risk from removed test coverage

    Removal of previous policy statements (e.g., for certain in vitro tests) may change coverage expectations and result in claim denials if services are billed assuming the removed statements remain effective. Review updated policy language and communicate changes to billing teams to avoid denied claims.

    • Risk from removed test coverage: prior assumptions about coverage that are no longer in the policy may cause denials.
    • Review the policy revision history and update billing/practice patterns accordingly.
    Step Therapy

    Step therapy

    Step therapy is not explicitly required by this policy; comparative evidence is discussed but no mandatory step‑therapy rules are imposed. Providers should still document prior pharmacologic management and reasons for initiating immunotherapy when applicable.

    • No explicit step therapy rules are stated in this policy.
    • Document prior medication trials and clinical reasons for escalation to immunotherapy.

    Background

    Allergic conditions arise from IgE‑mediated or cell‑mediated immune responses to environmental, food, drug, or other allergens. Diagnostic evaluation includes in vivo skin testing (prick/puncture and intradermal testing, patch and photo patch testing, provocation/challenge, and serial endpoint titration when needed) and in vitro serum assays for specific IgE when skin testing is contraindicated or inconclusive. These tests help identify sensitization to guide allergen avoidance and selection of targeted immunotherapy when indicated.

    Definitions

    In vivo testing
    DefinitionIn vivo testing: Procedures administering allergen on, in, or near the patient and monitoring physiologic response (e.g., skin prick/puncture, intradermal, patch testing, provocation/challenge).
    PurposeUsed to confirm IgE-mediated hypersensitivity and identify causative allergens by observing physiologic skin or organ responses.
    When usedIndicated when clinical history suggests IgE-mediated allergy or when specific diagnostic criteria for in vivo testing are met.
    In vitro testing
    DefinitionIn vitro testing: Laboratory analysis of serum for specific or total IgE (e.g., ImmunoCAP, RAST, ELISA) used when skin testing is contraindicated, inconclusive, or as adjunctive testing.
    Common methodsExamples include ImmunoCAP, RAST, MAST, FAST, PRIST, RIST, and ELISA.
    Frequency limitWhen medically necessary, allergen specific IgE testing (CPT 86003) limited to 80 units per rolling 12 months
    Serial endpoint titration (SET)
    TermSerial endpoint titration (SET)
    DescriptionA variation of intradermal testing using increasing antigen doses to determine the concentration at which a reaction becomes positive (the endpoint).
    UseMay guide safe starting doses for immunotherapy or testing when risk for severe systemic reaction/anaphylaxis exists (e.g., bee venom).
    Bead-based epitope assay (BBEA)
    TermBead-based epitope assay (BBEA)
    DescriptionHigh-throughput multiplex assay measuring IgE/IgG4 reactivity to discrete allergen epitopes (e.g., Luminex-based platforms such as VeriMAP™).
    Coverage stanceConsidered investigational/insufficient evidence for routine clinical use; specific assays (e.g., VeriMAP™ Peanut Dx/Sensitivity) are not covered.
    CSMS (Combined Symptom and Medication Score)
    TermCSMS (Combined Symptom and Medication Score)
    DescriptionEAACI-recommended endpoint for pivotal immunotherapy studies measuring combined symptoms and medication use.
    ContextUsed as a primary outcome in randomized trials (e.g., Pfaar et al. 2019) assessing SLIT efficacy.
    Allergen immunotherapy
    DefinitionAllergen immunotherapy: Therapies including subcutaneous (SCIT), sublingual (SLIT), epicutaneous, and oral routes to induce tolerance to specific allergens.
    Coverage stanceSCIT is considered medically necessary when criteria are met; sublingual antigen extract drop preparations (non–FDA-approved liquid drops) are not covered or reimbursable; FDA-approved SLIT tablet products are addressed under separate drug/biologic policies.
    Professional servicesSupervision and preparation services for immunotherapy are covered within limits (see CPT 95165 threshold).
    In vitro allergy testing
    DefinitionIn vitro allergy testing: Laboratory-based tests assessing serum biomarkers (including specific IgE assays and formerly referenced tests such as metal LTT and LHR).
    Policy notePolicy statements referencing metal LTT and LHR in vitro tests were removed from the policy (no longer present as supported covered statements).
    When appropriateIn vitro testing is medically necessary under defined clinical indications and subject to frequency limits (e.g., CPT 86003 up to 80 units/rolling 12 months).

    Revision History

    2026-04-15Annual reviewLatest

    Policy last reviewed on 04/15/2026 (last_review date in brief) — routine annual review recorded in profile metadata.

    2025-04-15Annual review

    Removed policy statements related to in vitro metal LTT for joint replacement surgery and LHR in vitro allergy testing.

    2024-05-15Annual review

    No changes to coverage noted during the 05/15/2024 annual review.

    2023-12-03Focused review

    Added policy statements regarding limits on allergy testing and preparation of allergen immunotherapy; removed the not medically necessary statement for in vitro allergy testing and subcutaneous allergen immunotherapy; updated experimental/investigational policy language for allergy testing.