Cigna allergy testing coverage update

Coverage Criteria — Allergy Testing & Immunotherapy

Medical necessity criteria

In vivo and in vitro allergy testing and certain non-pharmacologic immunotherapy are covered when criteria below are met.

In vivo skin testing - general: Prick/puncture testing to diagnose suspected IgE-mediated hypersensitivity to inhalants, foods, hymenoptera (e.g., bee venom), drugs and/or chemicals; intradermal (intracutaneous) testing to diagnose suspected IgE-mediated hypersensitivity to inhalants, hymenoptera, drugs and/or chemicals; patch testing to diagnose suspected contact allergic dermatitis; photo patch testing to diagnose suspected contact photosensitization; skin patch testing prior to joint replacement when either prior implant had complications suspected to be caused by metal allergy OR there is a history of severe localized (blistering, hives, extensive rash) or systemic cutaneous reaction to metals; skin patch testing following joint replacement when BOTH (1) presence of symptoms attributable to metal allergy/hypersensitivity (e.g., pain, swelling, cutaneous rash, loss of function) and (2) other etiologies (e.g., infection, mechanical failure) have been ruled out; food/food additive double-blind ingestion challenge when skin testing is negative or equivocal but history/physical findings suggest hypersensitivity; drug provocation/bronchial challenge when drug is required, no effective alternative exists, and confirming/excluding hypersensitivity outweighs risk; serial endpoint titration (SET) to determine a safe starting dose for testing or immunotherapy when potential exists for severe systemic reaction or anaphylaxis (e.g., bee venom).see frequency limits

See individual test descriptions and contraindications in policy

In vitro testing indications: Specific IgE immunoassays are medically necessary when any of the following apply: severe dermatographism/ichthyosis/generalized eczema; inability to discontinue medications that interfere with skin testing (e.g., long-acting antihistamines, tricyclic antidepressants); history suggesting unusually high risk for anaphylaxis or prior systemic reaction to skin testing; skin testing equivocal/inconclusive and confirmatory in vitro testing required; mental or physical impairment precluding skin testing; when skin testing is negative in the setting of clear sting anaphylaxis history, measure serum specific IgE and repeat skin testing in 3–6 months if indicated.see frequency limits

Specific IgE assays have limited sensitivity for venoms, penicillin and other drugs and should not be used as definitive diagnostic tests; cord blood measurements are not diagnostic or prognostic

Immunotherapy - subcutaneous: Subcutaneous allergen immunotherapy (SCIT) is medically necessary for treatment of allergic rhinitis, allergic conjunctivitis, and allergic asthma (with natural exposure to relevant allergens) when the patient demonstrates specific IgE to relevant allergens and symptoms persist despite or after pharmacologic management and observation.professional supervision dose limit applies

Consider severity, duration, patient preference/adherence, medication requirements, response to avoidance, and adverse effects; maintenance therapy generally 3–5 years for optimal benefit; sublingual drop preparations are not covered and FDA-approved sublingual products are addressed under separate pharmacy policies

Appropriate use of in vitro specific IgE testing

In vitro specific IgE immunoassays may be appropriate when ALL of the following apply:

In vitro IgE testing indications: Patient has a contraindication to skin testing or skin testing is impractical or impossible.

Situations include severe dermatographism, ichthyosis or generalized eczema; inability to discontinue interfering medications (e.g., long-acting antihistamines, tricyclic antidepressants); history suggesting high anaphylaxis risk or prior systemic reaction to skin testing; mental or physical impairment; and when skin testing is negative despite a clear history of sting anaphylaxis (measure serum specific IgE and consider repeat skin testing in 3–6 months).

Indications for metal allergy testing related to implants

Metal hypersensitivity testing (patch or in vitro) for arthroplasty-related concerns may be considered when ALL of the following apply:

When to test for metal hypersensitivity: Patient has a history of severe localized or systemic cutaneous reactions to metals OR a prior implant with complications suspected to be caused by metal allergy.

Exclude infection and mechanical failure before attributing implant complications to hypersensitivity; routine preoperative screening is not established and testing has no predictive value when performed routinely preoperatively; in select cases consider patch testing and/or in vitro testing as part of work-up.

Coverage criteria for subcutaneous allergen immunotherapy (SCIT)

Subcutaneous allergen immunotherapy (SCIT) is covered when ALL of the following are met:

SCIT candidate criteria: Patient has allergic rhinitis, allergic conjunctivitis, or allergic asthma with demonstrated specific IgE to relevant allergens and symptoms that persist despite or after a period of pharmacologic management and observation.

Consider severity/duration of symptoms, patient preference and adherence, medication requirements, response to avoidance, and adverse effects; expected benefit is antigen-specific; maintenance therapy of 3–5 years is generally optimal for maximal benefit.

Sublingual immunotherapy (liquid drops) — limited/conditional

Sublingual liquid/drop immunotherapy (SLIT drops) — coverage stance and evidence summary

SLIT drops evidence: Published evidence is mixed with low-to-moderate quality; meta-analyses and RCTs show reductions in symptoms and medication use versus placebo but heterogeneity in methods, dosing, duration, and outcomes limits conclusions. No FDA-approved liquid drop preparations are available in the U.S., and professional societies do not endorse off-label liquid drop formulations.

Randomized trials demonstrate some efficacy for certain allergens but heterogeneity and lack of head-to-head trials with SCIT and absence of standardized, approved liquid drop products limit routine endorsement.

When SLIT is considered: Use of FDA-approved sublingual tablet products per pharmacy/drug policies may be acceptable; liquid extract drop preparations used off-label are without endorsement and not recommended for routine use.

Refer to Pharmacy Coverage Policy for FDA-approved sublingual products; off-label liquid drop preparations are not endorsed due to insufficient evidence and lack of FDA approval.

BBEA (epitope mapping) — investigational / unproven

Bead-based epitope assays (BBEA) for food allergy — coverage stance

BBEA evidence: Current published evidence primarily consists of cohort and comparative case-control studies with relatively small sample sizes; there is insufficient evidence that BBEA improves clinical outcomes compared to alternative testing modalities.

More rigorous, larger studies are needed before routine clinical adoption; specific commercial multi-epitope peanut assays (e.g., VeriMAP™) are identified in policy exclusions as not covered.

General medical necessity

Allergy testing and allergen immunotherapy are considered medically necessary when the applicable policy statements' criteria are met.

General medical necessity statement: Testing (in vivo and in vitro) and allergen immunotherapy (subcutaneous) are considered medically necessary when the specific criteria in the applicable policy statements above are satisfied.

Specific criteria and limits (e.g., frequency limits, and 95165 professional supervision/provision dose limit) apply as indicated elsewhere in the policy.

Bead-based epitope assays (BBEA) such as VeriMAP™ Peanut Dx and VeriMAP™ Peanut Sensitivity are explicitly not covered or reimbursable. Likewise, sublingual antigen extract drop immunotherapy preparations (liquid SLIT drops) are not covered or reimbursable when billed as such. These exclusions reflect current evidence limitations for multiplex epitope assays and the lack of endorsement for off‑label liquid sublingual formulations.

Testing that exceeds the stated rolling 12‑month frequency limits is not covered or reimbursable. The policy specifies a maximum of 80 percutaneous tests (CPT 95004), 40 intracutaneous tests (CPT 95024), and 80 allergen-specific IgE tests (CPT 86003) per rolling 12 months; claims exceeding these thresholds may be denied.

In vitro specific IgE immunoassays have limited sensitivity for certain allergens and drugs and therefore should not be used alone to provide definitive diagnoses for venoms, penicillin, and other drugs. The policy notes overall sensitivity versus skin tests ranges broadly (about 50–90%) and cautions that false‑negative results can have serious consequences; specific IgE measured in cord blood likewise does not provide diagnostic or prognostic information.

Routine preoperative metal allergy testing prior to joint arthroplasty is not established. The policy states in vitro allergy testing is not indicated when there are no contraindications to skin testing or in patients with mild symptoms successfully managed medically; testing should be reserved for patients with prior implant complications suspected to be allergic and after excluding infection and mechanical failure.

Use of CPT codes 95165 or 95199 to report sublingual antigen extract drop immunotherapy preparations is not covered or reimbursable. The policy explicitly lists these codes as not payable when used to report liquid SLIT drop preparations and advises providers to follow applicable coding guidance for covered allergen immunotherapy services.

The annual/focused review removed prior policy statements concerning in vitro lymphocyte transformation testing (LTT) for joint replacement and LHR in vitro allergy testing. In their place the policy added explicit statements about frequency limits for allergy testing and requirements for preparation/provision of allergen immunotherapy, which may affect coding and prior authorization workflows.

Sublingual antigen extract drop immunotherapy preparations are not covered or reimbursable. The policy separates liquid SLIT drop preparations from FDA‑approved sublingual tablet products and indicates off‑label liquid formulations lack endorsement and are not payable when billed as such.

Liquid SLIT drop preparations are unapproved in the U.S., the published evidence is mixed and of limited quality, and professional societies do not endorse off‑label liquid sublingual formulations. For these reasons the policy does not endorse use of liquid SLIT drops and treats such preparations as unsupported by sufficient evidence and without FDA approval.

Reporting and reimbursement guidance: services billed with codes used to report sublingual antigen extract drop preparations (for example, 95165 or 95199) are not covered or reimbursable when used for liquid SLIT drops. Additionally, specific multi‑epitope peanut molecular assays (CPTs 0165U and 0178U) are listed as not covered.

During the focused review the prior ‘not medically necessary’ statement for in vitro allergy testing and subcutaneous allergen immunotherapy was removed. The policy instead emphasizes updated limits on testing frequency and immunotherapy preparation and clarifies experimental/investigational language for certain assays.

Coding Information and Limits

Covered CPT Codes - In vivo percutaneousCPTCovered

95004

Percutaneous (scratch, puncture, prick) testing

Covered CPT Codes - In vivo intracutaneousCPTCovered

95024

Intracutaneous (intradermal) testing

Covered CPT Codes - In vitro specific IgECPTCovered

86003

Allergen specific IgE; quantitative or semiquantitative testing

Covered CPT Codes - Allergen immunotherapy supervision (limited)CPTCovered

95165

Professional services for supervision of preparation and provision of antigens for allergen immunotherapy

Related coverage determinations / LCDmixed

L34063

LCD RAST Type Tests (CGS Administrators, LLC)

Covered testing CPT codesCPTCovered

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 tests, sequential and incremental, with allergenic extracts for airborne allergens, immediate type reaction, including test interpretation and report, specify number of tests.
95028	Intracutaneous tests with allergenic extracts, delayed type reaction, including reading, specify number of tests.
95044	Patch or application test(s) (specify number of tests).

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Covered treatment CPT codesCPTCovered

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 the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses).

Not covered molecular assay CPT/HCPCS codesHCPCSNot Covered

0165U	Peanut allergen-specific quantitative assessment of multiple epitopes using ELISA, blood, individual epitope results and probability of peanut allergy.
0178U	Peanut allergen-specific quantitative assessment of multiple epitopes using ELISA, blood, report of minimum eliciting exposure for a clinical reaction.

Not reimbursable for sublingual extract drop preparationsCPTNot Covered

95165	Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses).
95199	Unlisted allergy/clinical immunologic service or procedure

inv-27: Percutaneous testing limit — CPT 95004

LimitPercutaneous (scratch, puncture, prick) testing (CPT 95004) — maximum 80 units per rolling 12 months

Policy statusTests exceeding 80 units per rolling 12 months are not covered or reimbursable

CodingReport using CPT code 95004 with units specified

inv-28: Intracutaneous testing limit — CPT 95024

LimitIntracutaneous (intradermal) testing (CPT 95024) — maximum 40 units per rolling 12 months

Provider Actions, Documentation & Billing Guidance

Prior Authorization

Prior Authorization Required for Metal Allergy Testing

Prior authorization may be required for metal allergy testing (patch or in vitro) in the context of arthroplasty or suspected implant-related hypersensitivity. Routine preoperative patch testing prior to joint arthroplasty is not recommended unless the patient has a prior implant with suspected allergic complications or a history of clinically significant metal intolerance.

Preoperative testing: reserve for patients with prior implant complications suspected to be allergic or a history of significant clinical metal intolerance.
If testing is ordered, document the clinical rationale (e.g., prior implant failure with suspected hypersensitivity) and rule out infection/mechanical causes before attributing failure to allergy.

Prior Authorization

Prior Authorization Implications of New Testing/Preparation Limits

Added testing and immunotherapy preparation limits in this policy have operational prior authorization implications. Providers should verify PA requirements before scheduling services that approach or exceed stated limits.

95165/95144 professional supervision of antigen provision is subject to the annual dose limit of 150 doses per rolling 12 months; claims exceeding this will be subject to denial and may require PA justification.

Definitions and Background

Allergic disease reflects immune overreaction typically mediated by IgE antibodies, producing immediate hypersensitivity symptoms and, in some conditions, delayed reactions. Diagnostic testing includes in vivo skin testing (prick/puncture, intradermal, patch) and in vitro serum specific IgE assays; skin testing remains the preferred diagnostic method but in vitro testing is appropriate in specific circumstances (e.g., severe dermatographism, inability to discontinue antihistamines, prior systemic reaction to skin testing). Testing and immunotherapy decisions should be guided by clinical history, test limitations, and the policy’s specified frequency and preparation limits.

inv-50: Definition - In vivo allergy testing (key features)

DefinitionIn vivo allergy testing: tests performed on or near the patient (skin or organ provocation) that monitor physiologic response to administered allergens

Common methodsIncludes percutaneous (prick/puncture) testing, intracutaneous (intradermal) testing, patch testing, photo patch testing, and organ challenge/provocation tests

Indications/contraindicationsUsed to verify IgE-mediated hypersensitivity; contraindicated in severe dermatographism, ichthyosis, generalized eczema, inability to stop interfering medications, or prior systemic reaction to skin testing

OpenPayer

Allergy testing and non‑pharmacologic allergen immunotherapy

Coverage Criteria — Allergy Testing & Immunotherapy

Coding Information and Limits

Provider Actions, Documentation & Billing Guidance

Definitions and Background