CurrentCignaPolicy 0070

Allergy testing and non-pharmacologic allergen immunotherapy

Defines medical necessity, frequency limits, and coverage exclusions for in vivo and in vitro allergy testing and non-pharmacologic immunotherapy (subcutaneous and sublingual) for Cigna-administered health benefit plans. Includes indications for testing, treatment (SCIT), limits on units, and exclusions such as bead-based epitope assays and sublingual drop preparations.

Policy Summary

PayerCigna

PolicyAllergy testing and non-pharmacologic allergen immunotherapy

Policy CodePolicy 0070

Change TypeAnnual review (04/15/2025) with removals; prior focused updates added limits and updated investigational language

Effective DateApr 15, 2025

Next Review DateApr 15, 2026

Key ActionSubmit supporting clinical documentation showing the indication meets listed medical necessity criteria before billing (e.g., contraindication to skin testing, prior systemic reaction, equivocal skin tests, need to evaluate venom cross-reactivity).

POLICY UPDATE CHANGES

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

No changes to coverage.

Added policy statements regarding testing limits on allergy testing and preparation of allergen immunotherapy.

Removed the not medically necessary policy statement for in vitro allergy testing and subcutaneous allergen immunotherapy.

Updated the experimental/investigational or unproven policy statement for allergy testing.

80Max percutaneous test units/12 months

40Max intradermal test units/12 months

Coverage Summary

Scope: This policy applies to health benefit plans administered by Cigna Companies and defines medical necessity, frequency limits, and coverage exclusions for in vivo (skin and provocation) and in vitro (serum IgE) allergy testing and non-pharmacologic allergen immunotherapy (subcutaneous and sublingual) for Cigna-administered plans. Effective date: 04/15/2025. Status: CURRENT.

High-level overview: Medically necessary services covered include specified in vivo skin tests (percutaneous/prick/puncture, intradermal, patch, photo patch), organ provocation/challenge tests (e.g., ingestion challenge, bronchial challenge), and in vitro allergen-specific IgE testing when policy criteria are met. Limits apply to test frequency/units: percutaneous testing (CPT 95004) ≤ 80 units/rolling 12 months, intracutaneous testing (CPT 95024) ≤ 40 units/rolling 12 months, and allergen specific IgE testing (CPT 86003) ≤ 80 units/rolling 12 months. Subcutaneous allergen immunotherapy (SCIT) is covered for allergic asthma and allergic rhinitis (with/without conjunctivitis) with professional supervision codes covered but subject to dose limits. Not covered/not reimbursable items include bead-based epitope assays (e.g., VeriMAP) and certain peanut epitope U-codes (0165U, 0178U), and sublingual antigen extract drop preparations are not reimbursable (refer to separate drug/biologic policies for FDA-approved sublingual products).

Key thresholds and quick facts from policy

Percutaneous (95004) - max units (rolling 12 months)80 units

Intracutaneous/intradermal (95024) - max units (rolling 12 months)40 units

Allergen-specific IgE (86003) - max units (rolling 12 months)80 units

Supervision of antigen preparation (95165) - max doses (rolling 12 months)150 doses per year

Not-covered specific codes0165U, 0178U, 95199 (listed as not covered/not reimbursable)

Medically Necessary — In Vivo Allergy Testing

Medically Necessary In Vivo Allergy Tests

When in vivo allergy testing is considered medically necessary, the following criteria apply. Preserve nested logic for pre- and post-arthroplasty patch testing.

ALL of the following

prick/puncture (percutaneous) allergy testing to diagnose suspected immunoglobulin E (IgE)-mediated hypersensitivity to inhalants, foods, hymenoptera (e.g., bee venom), drugs and/or chemicals.
intradermal (intracutaneous) allergy testing to diagnose suspected immunoglobulin E (IgE)-mediated hypersensitivity to inhalants, hymenoptera (e.g., bee venom), drugs and/or chemicals.
skin patch testing to diagnose suspected contact allergic dermatitis.
photo patch testing to diagnose suspected contact photosensitization (e.g., photoallergic contact dermatitis).

Medically Necessary — In Vitro Allergy Testing

Medically Necessary — Allergen Immunotherapy

Contraindications / When Skin Testing is Inappropriate

Not Covered / Not Reimbursable Services

Not Covered / Not ReimbursablemixedNot Covered

	Bead-based epitope assay (e.g., VeriMAP™ Peanut Dx, VeriMAP™ Peanut Sensitivity) - not covered or reimbursable
	Sublingual antigen extract drop immunotherapy preparations - not covered or reimbursable (see separate drug/biologic policies for FDA-approved sublingual products)

Not covered / Not reimbursable codesCPTNot Covered

0165U	Peanut allergen-specific quantitative assessment of multiple epitopes using ELISA; individual epitope results and probability of peanut allergy - not covered or reimbursable
0178U	Peanut allergen-specific quantitative assessment of multiple epitopes using ELISA; report of minimum eliciting exposure for a clinical reaction - not covered or reimbursable
95165	Use of CPT 95165 to report sublingual antigen extract drop immunotherapy preparations - not covered or reimbursable
95199	Unlisted allergy/clinical immunologic service or procedure used to report sublingual antigen extract drop immunotherapy preparations - not covered or reimbursable

Coding

In Vivo Testing CPT Codes (with frequency limits)CPTCovered

95004	Percutaneous (scratch, puncture, prick) testing - limit 80 units per rolling 12 months
95024	Intracutaneous (intradermal) testing - limit 40 units per rolling 12 months

In Vitro Testing CPT Code (with frequency limits)CPTCovered

86003

Allergen specific IgE; quantitative or semiquantitative testing - limit 80 units per rolling 12 months

Medically necessary allergy testing CPTCPTCovered

86003	Allergen specific IgE; quantitative or semiquantitative, crude allergen extract, each
86005	Allergen specific IgE; qualitative, multiallergen screen (eg, disk, sponge, card)
86008	Allergen specific IgE; quantitative or semiquantitative, recombinant or purified component, 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 and intracutaneous, with venoms, immediate type reaction, including test interpretation and report, specify number of tests
95018	Allergy testing, any combination of percutaneous and intracutaneous, 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)

1–10 of 14

1/2

Medically necessary allergen immunotherapy CPTCPTCovered

95115	Professional services for allergen immunotherapy not including provision of allergenic extracts; single injection
95117	Professional services for allergen immunotherapy not including provision of allergenic extracts; 2 or more injections
95120	Professional services for allergen immunotherapy including provision of allergenic extract; single injection
95125	Professional services for allergen immunotherapy including provision of allergenic extract; 2 or more injections
95144	Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy, single dose vial(s) (specify number of vials)
95165	Professional services for supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses). Note: covered up to 150 doses per year (rolling 12 months); exceeding 150 doses/year not covered

Immunotherapy Supervision / PreparationCPT

95165	Professional services for supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens - professional services exceeding a maximum of 150 doses per year are not covered
95144	Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy, single dose vial(s) (specify number of vials)

Not covered / Not reimbursable codesCPTNot Covered

0165U	Peanut allergen-specific quantitative assessment of multiple epitopes using ELISA; individual epitope results and probability of peanut allergy - not covered
0178U	Peanut allergen-specific quantitative assessment of multiple epitopes using ELISA; report of minimum eliciting exposure for a clinical reaction - not covered
95199	Unlisted allergy/clinical immunologic service or procedure used to report sublingual antigen extract drop immunotherapy preparations - not covered

Other Not Covered / Not ReimbursablemixedNot Covered

95165	Use of CPT 95165 to report sublingual antigen extract drop immunotherapy preparations is not covered or reimbursable
	Sublingual antigen extract drop immunotherapy preparations (liquid extract drops) - products/preparations not systematically studied in US populations; not covered or reimbursable (refer to specific drug/biologic policies for FDA-approved sublingual products)
	Note: Professional services for supervision of antigen preparation (95165) exceeding 150 doses per rolling 12 months are not covered/reimbursable

Provider Actions & Billing Rules

Documentation Required

Justify in vivo/in vitro testing

Document the medical necessity for in vivo or in vitro testing in the medical record at the time of service. Include clinical indication, relevant history (e.g., medication interference with skin testing, prior systemic reaction to skin testing, severity of dermatitis), and rationale for test selection (why in vivo versus in vitro). Failure to document medical necessity may result in claim denial.

Affected codes: 95004, 95024, 86003

Billing Rule

Adhere to frequency limits

Adhere to the stated frequency limits and dose limits when billing; claims exceeding these limits will be denied as not covered. For supervised antigen preparation (CPT 95165), do not bill more than the allowed dose limit in a rolling 12‑month period.

Percutaneous testing (CPT 95004): limit 80 units per rolling 12 months

Background & Evidence Summary

Background (brief clinical context): IgE-mediated allergies occur when antigen-specific IgE binds to mast cells and basophils and triggers immediate hypersensitivity responses. Testing modalities include in vivo procedures (skin prick/puncture, intradermal, patch, photo patch, and provocation/challenge tests) and in vitro assays (serum allergen-specific IgE such as ImmunoCAP, RAST, ELISA).

Clinical indications and contraindications: Skin testing (in vivo) is the preferred/‘gold standard’ for diagnosing IgE-mediated disease but is contraindicated in patients with severe dermatographism, ichthyosis, generalized eczema, inability to withdraw medications that interfere with testing, or prior systemic reaction to skin testing. In vitro testing is appropriate when skin testing is contraindicated, inconclusive, or when evaluating venom cross-reactivity or certain adjunctive uses.

Evidence considerations and limitations: In vitro assays (e.g., ImmunoCAP) have variable sensitivity/specificity versus skin tests (ImmunoCAP sensitivity ~80–95%, specificity ~~85%; overall in vitro sensitivity vs skin tests ~50–90%, average ~70–75%). Some newer modalities (e.g., bead-based epitope assays/BBEA, certain epitope U-codes) have limited, low-quality evidence and are not covered pending more rigorous studies. Serial endpoint titration (SET) may be used to determine safe starting doses for testing or immunotherapy when there is significant risk for severe systemic reactions (e.g., bee venom).

Rationale for treatment coverage: Subcutaneous allergen immunotherapy (SCIT) is an established, evidence-based treatment for allergic rhinitis, conjunctivitis, allergic asthma, and venom hypersensitivity; recommendations for SCIT consider prior pharmacologic management, symptom severity, patient preference, and typical maintenance duration of 3–5 years for optimal benefit. Evidence does not support immunotherapy for atopic dermatitis, chronic urticaria, angioedema, or food hypersensitivity.

Evidence / Source	Key finding
ImmunoCAP sensitivity vs RAST
ImmunoCAP sensitivity 80-95% and specificity ~85% compared to skin prick testing

Definitions / Glossary:

Medicare Determinations (NCDs / LCDs)

Type	Name	Number	Effective Date
{"text":"NCD","status":""},{"text":"Food Allergy Testing and Treatment","status":""},{"text":"110.11","status":""},{"text":"1988-10-31","status":""}
{"text":"NCD","status":""},{"text":"Antigens Prepared for Sublingual Administration","status":""},{"text":"110.9","status":""},{"text":"1996-11-17","status":""}
{"text":"NCD","status":""},{"text":"Challenge Ingestion Food Testing","status":""},{"text":"110.12","status":""},{"text":"1978-08-01","status":""}
{"text":"NCD","status":""},{"text":"Cytotoxic Food Tests","status":""},{"text":"110.13","status":""},{"text":"1985-08-05","status":""}
{"text":"LCD","status":""},{"text":"RAST Type Tests (CGS Administrators, LLC)","status":""},{"text":"L34063","status":""},{"text":"2023-08-03","status":""}
{"text":"LCD","status":""},{"text":"Allergy Immunotherapy (CGS Administrators, LLC)","status":""},{"text":"L32553","status":""},{"text":"2023-11-02","status":""}
{"text":"LCD","status":""},{"text":"RAST Type Tests (National Government Services, Inc.)","status":""},{"text":"L33591","status":""},{"text":"2019-11-07","status":""}
{"text":"LCD","status":""},{"text":"Allergy Testing (Novitas Solutions, Inc.)","status":""},{"text":"L36241","status":""},{"text":"2021-07-11","status":""}
{"text":"LCD","status":""},{"text":"Allergen Immunotherapy (Novitas Solutions, Inc.)","status":""},{"text":"L36240","status":""},{"text":"2021-07-11","status":""}
{"text":"LCD","status":""},{"text":"Allergy Testing (Noridian Healthcare Solutions, LLC)","status":""},{"text":"L34313","status":""},{"text":"2019-10-01","status":""}
{"text":"LCD","status":""},{"text":"Allergy Testing (First Coast Service Options, Inc.)","status":""},{"text":"L33261","status":""},{"text":"2021-07-11","status":""}
{"text":"LCD","status":""},{"text":"Allergen Immunotherapy (First Coast Service Options, Inc.)","status":""},{"text":"L37800","status":""},{"text":"2021-07-11","status":""}
{"text":"LCD","status":""},{"text":"Allergy Testing (Wisconsin Physicians Service Insurance Corporation)","status":""},{"text":"L36402","status":""},{"text":"2022-10-01","status":""}
{"text":"LCD","status":""},{"text":"Allergy Immunotherapy (Wisconsin Physicians Service Insurance Corporation)","status":""},{"text":"L36408","status":""},{"text":"2023-10-26","status":""}
{"text":"LCD","status":""},{"text":"Allergy Skin Testing (Palmetto GBA)","status":""},{"text":"L33417","status":""},{"text":"2021-04-15","status":""}

Revision History

2025-04-15Annual ReviewLatest

Removed policy statements related to in vitro metal LTT for joint replacement surgery and LHR in vitro allergy testing. (detail) Annual Review dated 04/15/2025 removed these policy statements.

2024-05-15Annual Review

No changes to coverage. (detail) Annual Review dated 05/15/2024 noted no changes to coverage.

2023-12-03Focused Review

Added policy statements regarding testing limits and preparation of allergen immunotherapy; removed prior not medically necessary statements for in vitro allergy testing and subcutaneous allergen immunotherapy; updated experimental/investigational or unproven language. (detail) Focused Review dated 12/03/2023 added testing limits and preparation policy statements; removed not medically necessary policy statements for in vitro allergy testing and subcutaneous allergen immunotherapy; updated investigational/unproven language.

Policy Summary

PayerCigna

PolicyAllergy testing and non-pharmacologic allergen immunotherapy

Policy CodePolicy 0070

Change TypeAnnual review (04/15/2025) with removals; prior focused updates added limits and updated investigational language

Effective DateApr 15, 2025

Next Review DateApr 15, 2026

On This Page

Skin patch testing related to joint replacement

- previous surgery involving an implant with complications suspected to be caused by metal allergy.
- history of severe localized (e.g., blistering, hives, and/or extensive rash) or systemic cutaneous reaction to metals.
Post-arthroplasty patch testing
- skin patch testing performed following joint replacement surgery when BOTH of the following criteria are met:
- presence of symptoms attributable to metal allergy/hypersensitivity (e.g., pain, swelling, cutaneous rash, loss of function).
- etiology other than metal allergy/hypersensitivity (e.g., infection, mechanical failure) have been ruled out.

Billing Rule

Dose limit for supervised antigen preparation (95165)

Apply the dose restriction for professional supervision and preparation of antigens (CPT 95165). Supervision/preparation services that exceed 150 doses in any rolling 12‑month period are not covered. Claims for CPT 95165 beyond 150 doses per rolling 12 months will be denied.

CPT 95165: >150 doses per rolling 12 months not covered

Denial Risk

Sublingual antigen extract drop immunotherapy reporting restrictions

Sublingual antigen extract drop immunotherapy preparations are not covered under this policy; reporting for sublingual preparations is restricted and separate drug policies apply for FDA‑approved sublingual products. Providers should not bill sublingual antigen drop preparations under CPT 95165 or related immunotherapy supervision codes; instead, refer to applicable drug policy guidance.

Codes potentially impacted: 95165, 95199
Refer to drug policies for FDA‑approved sublingual products (see IP0515, IP0516, IP0518, 2004).

Billing Rule

Avoid using listed noncovered U‑codes for peanut epitope assays

Avoid billing the listed noncovered proprietary U‑codes for peanut epitope/bead‑based assays. These assay codes are considered not covered or experimental under this policy and will be denied if billed.

0165U — not covered
0178U — not covered