Allergy Testing and Immunotherapy
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Defines medical necessity, coverage criteria, documentation, and not-medically-necessary services for allergy testing (skin and in vitro) and allergen immunotherapy for members of Arizona Complete Health (Centene-affiliated health plans). Affects clinicians performing allergy evaluation, testing, and immunotherapy.
Added several CPT codes to the not medically necessary table and later removed some codes (86160, 86161, 86162) with addition of ICD-10 Table 7.
Specified certain antigens (cornstarch, cotton, formaldehyde, smog) as not medically necessary for testing.
Revised wording for sublingual therapy to 'non FDA approved sublingual immunotherapy' and referred sublingual coverage criteria to the pharmacy benefit.
Coverage and Medical Necessity Criteria
Allergy testing — general medical necessity
Covered when ALL of the following are met
Includes percutaneous, intradermal, skin endpoint, in vitro, patch and photo testing as specified in CPT Code Table 1
Allergen immunotherapy — coverage criteria
Covered when ALL of the following are met
Rapid desensitization/rush immunotherapy is medically necessary only for medication or hymenoptera sensitivities. For FDA‑approved sublingual immunotherapy refer to the pharmacy policy.
Immunotherapy treatment duration and assessment
Conditions for continuing therapy
Clinical benefit must be documented in the medical record; major risk is anaphylaxis and administration must meet safety requirements.
Medically necessary testing and immunotherapy
Covered procedures and services
See CPT Code Table 1 and ICD‑10 Code Tables for mapping of procedures to allowed diagnoses; professional services codes (e.g., 95115, 95117, 95144–95170, 95180) apply when indicated.
Not medically necessary
Not medically necessary procedures
Also includes specific unlisted and new technology allergen assays enumerated in CPT Code Table 2.
Immunotherapy schedules and duration
Treatment scheduling and duration
Schedule must be individualized based on patient risk and response.
Document clinical benefit to support continuation.
Safety requirements
Safety and administration
Evaluation and management (E/M) codes are separately reimbursable the same day only when a significant, separately identifiable service is performed.
Coverage criteria and not medically necessary items
Policy tables and revision history define covered vs not medically necessary tests and immunotherapy; the full criteria are in earlier sections
Added to the not medically necessary antigen list in the revision history.
See revision history and CPT Code Table 2 for details.
Providers should consult pharmacy benefit criteria for FDA‑approved sublingual products and non‑FDA sublingual protocols.
The policy lists an extensive set of antigens and testing modalities that are considered not medically necessary because safety or effectiveness have not been established. Examples of excluded antigens include newsprint, tobacco smoke, dandelion, orris root, phenol, alcohol, sugar, yeast, grain mill dust, soybean dust (unless occupational exposure documented), wool (unless continuous exposure to sheep or unprocessed wool), marigold, honeysuckle, fiberglass, green tea, chalk, cornstarch, cotton, formaldehyde, and smog.
The policy also enumerates numerous alternative, unvalidated, or experimental test methods and panels that are not medically necessary, including but not limited to ALCAT (automated food allergy testing), applied kinesiology/NAET, anti-Fc epsilon receptor antibody testing, blood/urine/stool micronutrient assessments, candidiasis testing, hair chemical analysis, chronic urticarial index testing, Clifford materials reactivity testing, electrodermal testing, electromagnetic sensitivity testing, environmental cultures/chemicals, ELISA/Act qualitative antibody testing, food immune complex assays (FICA), in vitro metal allergy testing, leukocyte/basophil histamine release tests, Live Cell Analysis, lymphocyte function assays, LRA/MRT/MRT-type mediator release tests, and VeriMAP Peanut Diagnostic™.
Additionally, the policy designates a range of services related to testing and immunotherapy as not medically necessary, such as desensitization with non-recommended extracts (e.g., poison ivy/oak/sumac, certain whole body extracts), bacterial vaccine desensitization, food allergenic extract immunotherapy, provocative/neutralization therapies (including Rinkel Test), repository emulsion therapy, non-FDA approved sublingual immunotherapy, urine autoinjection, home administration of immunotherapy, ingestion challenge food testing performed at home, and intradermal testing for food allergies.
CPT procedures explicitly listed as not medically necessary are documented in CPT Code Table 2. Examples from that table include 86332 (immune complex assay), 86343 (leukocyte histamine release test), 86485 (skin test; candida), 86628 (antibody; Candida), 95060 (ophthalmic mucous membrane tests), 95065 (direct nasal mucous membrane test), 0165U and 0178U (peanut epitope ELISA-based assessments).
Providers should reference the CPT Code Table 2 mapping in the policy when determining coverage for these specific procedures and confirm whether a billed CPT is designated not medically necessary in the current policy version.
Testing for cornstarch, cotton, formaldehyde, and smog is explicitly listed in the policy as not medically necessary and was added to the exclusions in the revision history.
Claims for testing that target these specific antigens may be denied under the policy unless they meet separate, explicit medical necessity criteria documented elsewhere in the member's record.
The policy identifies many additional antigens and a broad set of alternative or unvalidated diagnostic tests and services as not medically necessary. These include a wide variety of unconventional assays and procedures (see exclusions) such as ALCAT, applied kinesiology/NAET, electrodermal testing, MRT/LRA/mediator release assays, in vitro metal allergy testing, VeriMAP Peanut Diagnostic™, food immune complex assays, and numerous other immunologic and metabolic assessments.
It also lists disallowed services related to immunotherapy—examples include provocative and neutralization therapies, repository emulsion therapy, non-FDA approved sublingual immunotherapy, urine autoinjection, home administration of immunotherapy, intracutaneous desensitization procedures for food, and rush immunotherapy for inhalant allergens.
The policy identifies a set of CPT codes in CPT Code Table 2 that are not medically necessary. Table 2 entries include codes such as 86332, 86343, 86485, 86628, 95060, 95065, 0165U, and 0178U.
Revision history shows that additional CPT codes were added to the not medically necessary table during updates; providers should confirm the current table when determining coverage and billing.
The policy revision history documents that several CPT codes were added to the not medically necessary CPT Table 2 and later revised. Specifically, codes 86160, 86161, 86162, 86332, 86343, 86485, 86628, 0165U, and 0178U were placed in the not medically necessary table in prior revisions, and subsequently 86160–86162 were removed from that table in a later update.
Because codes have been added and removed over time, billing and prior authorization should be checked against the current policy tables and the provider fee schedule to ensure correct designation at the time of service.
CPT and ICD-10 Coding Tables
| 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, sequential and incremental, with venoms, immediate type reaction, including test interpretation and report, specify number of tests. |
| 95018 | Allergy testing, any combination of percutaneous and intracutaneous, sequential and incremental, 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). |
| 86332 | Immune complex assay. |
| 86343 | Leukocyte histamine release test (LHR). |
| 86485 | Skin test; candida. |
| 86628 | Antibody; Candida. |
| 95060 | Ophthalmic mucous membrane tests. |
| 95065 | Direct nasal mucous membrane test. |
| 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... report of minimum eliciting exposure for a clinical reaction. |
| B44.81 | Allergic bronchopulmonary aspergillosis. |
| H10.01 - H10.45 | Conjunctivitis (expanded range). |
| J30.1 - J30.9 | Allergic rhinitis. |
| J30.0 | Vasomotor rhinitis. |
| J31.0 | Chronic rhinitis. |
| J45.2 - J45.998 | Asthma. |
| L20.84 | Intrinsic (allergic) eczema. |
| L20.89 | Other atopic dermatitis. |
| L20.9 | Atopic dermatitis, unspecified. |
| L23.0 - L23.9 | Allergic contact dermatitis. |
| 86160 | specified in policy as not medically necessary (was later removed from NMN table) |
| 86161 | specified in policy as not medically necessary (was later removed from NMN table) |
| 86162 | specified in policy as not medically necessary (was later removed from NMN table) |
| 86332 | listed in not medically necessary CPT Table 2 |
| 86343 | listed in not medically necessary CPT Table 2 |
| 86485 | listed in not medically necessary CPT Table 2 |
| 86628 | listed in not medically necessary CPT Table 2 |
| 0165U | listed in not medically necessary CPT Table 2 |
| 0178U | listed in not medically necessary CPT Table 2 |
| 86008 | added to in vitro testing and CPT code table 1 |
| B44.81 | added to ICD-10 code table 1 |
| R06.2 | added to ICD-10-CM code table 1 |
| J30.0 | added to ICD-10-CM Code Table 1 |
| Z91.010-Z91.018 | ICD-10 code range added to Tables 1 & 4 |
Provider Responsibilities, Documentation, and Billing Guidance
Code-based coverage requirement
Coverage is determined by CPT/HCPCS codes listed in the policy code tables. Providers must bill only codes that are included in the "medically necessary" code table for covered services; codes listed in the "not medically necessary" table will be denied. Verify that the CPT code submitted matches the actual service performed and the policy's coverage status for that code.
- Refer to CPT Code Table 1 for procedure codes considered medically necessary and CPT Code Table 2 for procedure codes considered not medically necessary.
- Do not bill codes from the not medically necessary table; these codes are explicitly excluded from coverage.
Check prior authorization and code membership
Some CPT codes in this policy require prior authorization (PA) or have been added/removed in past revisions. Providers must check the payer's PA system or the member's benefit information before performing services to confirm current PA requirements and that the codes are listed as eligible for coverage.
- Verify PA requirements for codes newly added or removed in recent revisions.
- Confirm member-specific benefit coverage and PA status prior to scheduling testing or immunotherapy.
Not medically necessary triggers
The policy lists numerous tests and services that are considered not medically necessary — these are coverage triggers for denial if billed. Examples include unconventional or unproven tests (e.g., IgG testing, leukocyte histamine release test, many alternative diagnostic assays) and certain antigen testing listed as not medically necessary.
- Services/tests listed in III.A and III.C as not medically necessary will not be covered.
- Common not medically necessary examples include: testing of specific IgG, many food/alternative assays, urine autoinjection, non-FDA approved sublingual immunotherapy.
Not medically necessary CPT codes
Claims submitted with CPT codes that are listed in the policy's Not Medically Necessary CPT Code Table (CPT Code Table 2) are subject to denial. Providers should review the current CPT tables in this policy before submission.
Antigen-specific denials
Testing for the following specific antigens is designated not medically necessary and may result in claim denial when billed: cornstarch, cotton, formaldehyde, smog, and the other listed antigens in III.A of the policy.
- Do not perform or bill for testing of antigens listed in III.A (e.g., cornstarch, cotton, formaldehyde, smog, newsprint, tobacco smoke, dandelion, etc.) unless documentation demonstrates a clear, documented exposure and medical rationale consistent with policy exceptions.
- Added antigens (cornstarch, cotton, formaldehyde, smog) were explicitly included in recent revisions and are not covered.
Required documentation
Maintain complete medical record documentation to support medical necessity. Documentation must demonstrate diagnostic rationale, test methodology and results, and how results affect the plan of care.
- Include a complete medical and immunologic history and a face-to-face physical exam.
- Document the medical necessity for the test or therapy, test methodology, and quantitative results (mm for skin testing; kIU/L for specific IgE).
- Record interpretation of results and how they will be used in the patient's plan of care.
- Document periodic clinical evaluation of treatment benefits; if no benefit within 12–24 months, document consideration of alternative treatments and rationale for continuation/termination.
- Perform clinical re-evaluation every 3–5 years to determine need for ongoing immunotherapy.
Supervision and E/M billing
Allergen immunotherapy must be administered under the supervision of an appropriately trained physician in a facility equipped to manage anaphylaxis. Evaluation and management (E/M) services are separately reimbursable on the same day only when a significant, separately identifiable service is performed.
- Ensure facility readiness to recognize and treat anaphylaxis and that supervising physician is immediately available.
- If billing E/M on the same day as allergen immunotherapy, document the separate, significant E/M service performed to justify separate reimbursement.
Therapy escalation requirement
Immunotherapy should be considered only after avoidance measures and appropriate pharmacologic therapy have failed to control symptoms or caused unacceptable side effects. Rapid desensitization/rush immunotherapy is medically necessary only for medication or hymenoptera venom sensitivities.
- Document prior trials of avoidance and pharmacologic therapy and reasons for failure or intolerance.
- For rapid desensitization/rush protocols, document indication limited to medication or hymenoptera venom sensitivities per policy.
Background and Scope
Allergy testing and immunotherapy encompass multiple modalities used to identify IgE‑mediated sensitivity and to modify immune responses. Percutaneous (scratch/puncture/prick) testing with standardized extracts (CPTs such as 95004, 95017, 95018) is the preferred initial test for immediate hypersensitivity when clinically appropriate, while intradermal testing/skin endpoint titration (CPTs 95024, 95027, 95028) is used when greater sensitivity is required or to establish starting immunotherapy doses.
When skin testing is contraindicated or impractical, in vitro specific IgE testing (e.g., RAST, ELISA, ImmunoCAP; CPTs 86003, 86005, 86008) provides quantitative or qualitative measures of allergen-specific IgE and informs diagnosis and treatment planning. Immunotherapy involves repeated administration of identified allergens to achieve clinical improvement; safety considerations include the risk of anaphylaxis, requiring administration under appropriate medical supervision in facilities equipped to manage systemic reactions.
Key Definitions and Test Descriptions
Policy Revision Timeline
Multiple CPT codes were added to the not medically necessary CPT Table 2 (86160, 86161, 86162, 86332, 86343, 86485, 86628, 0165U, 0178U).
R06.2 was added to ICD-10-CM Code Table 1; wording revised to describe sublingual therapy as 'non FDA approved sublingual immunotherapy' and referral to the pharmacy benefit for coverage criteria; a background statement about in vitro testing was removed.
Codes 86160, 86161, and 86162 were removed from the not medically necessary table and ICD-10 Table 7 was added to list diagnoses that do not support medical necessity for those codes.
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