Allergy Testing
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This policy governs medical necessity and coverage for allergy testing (skin tests, challenge tests, and in vitro IgE testing) for Providence Health Plan members across applicable commercial products. It defines which tests are considered medically necessary, not medically necessary, and when in vitro testing is appropriate.
No material clinical or coverage changes in this revision.
Coverage Criteria — Medically Necessary and Not Medically Necessary Tests
inv-01: In Vivo Allergy Testing
The following in vivo allergy tests are considered medically necessary when clinically indicated:
Listed as items A–F in policy
inv-02: In Vitro Allergy Testing
In vitro allergy testing may be considered medically necessary when ALL of the following are met:
CPT examples provided: 86003, 86008; PRIST/RIST CPT 82785
inv-03: In Vitro - Not Medically Necessary If Criteria Not Met
Not medically necessary condition for in vitro testing:
Policy statement III: testing is not medically necessary when II is not met
inv-04: Not Medically Necessary Tests (Specific List)
The following tests are considered not medically necessary:
Also: multiallergen IgE screening (CPT 86005) is listed separately as not medically necessary
inv-05: Medically necessary/covered testing
Covered when consistent with evidence-based guidelines and clinical indications:
Serum sIgE useful when skin testing cannot be performed (e.g., extensive dermatitis, dermatographism, or inability to stop antihistamines)
DBPCFC is gold standard per NIAID guidance
Guideline-referenced indications for total IgE
AAAAI recommends serum testing when skin tests are negative
inv-06: Not medically necessary / investigational
Not medically necessary / investigational tests:
These tests lack sufficient evidence and are considered not medically necessary or investigational
Multiallergen testing (CPT 86005) does not identify specific antigens and is listed as not medically necessary
Multiallergen IgE screening using CPT code 86005 is designated as not medically necessary and is not covered under this policy.
The policy identifies a set of tests that lack sufficient evidence or are recommended against in guidelines and therefore are not medically necessary. Examples include: Antigen Leukocyte Cellular Antibody (ALCAT) automated food test; Applied kinesiology; Bead-Based Epitope Assay (BBEA); Cytotoxic food test; Sublingual provocation; Iridology; Hair analysis; IgG/IgG4 allergen-specific antibody testing; Provocation-neutralization tests (e.g., Rinkel); Leukocyte histamine release test (LHRT); and conjunctival or nasal challenge tests.
Non-standardized assays and specialized cytotoxic/ALCAT testing are excluded as not medically necessary. The policy specifically notes that when CPT 83516 is billed to represent ALCAT or cytotoxic food testing, it will be considered not medically necessary.
All unlisted procedure codes are subject to claim-level review. If an unlisted code is submitted for a service that is non‑covered under this policy, it will be denied as not covered.
The policy lists multiple specific tests that are considered not medically necessary, including but not limited to: (A) Antigen Leukocyte Cellular Antibody (ALCAT) automated food test; (B) Applied kinesiology; (C) Bead-Based Epitope Assay (BBEA); (D) Conjunctival or nasal challenge tests; (E) Cytotoxic food test; (F) Sublingual provocation; (G) Iridology; (H) Hair analysis; (I) IgG/IgG4 allergen-specific antibody test; (J) Leukocyte histamine release test (LHRT); and (K) Provocation‑neutralization food or additive allergy tests (e.g., Rinkel test). These tests are unsupported by adequate evidence or are recommended against in clinical guidance.
The policy aligns with guideline recommendations from AAAAI/ACAAI/JCAAI and NIAID: validated tests (skin prick/puncture tests, serum allergen‑specific IgE, and oral food challenges where indicated) are recommended for diagnosing food and inhalant allergies, while unproven or non‑standardized tests (including allergen‑specific IgG/IgG4, cytotoxicity assays, applied kinesiology, provocation‑neutralization, and hair analysis) are not recommended for routine evaluation.
Non‑standardized tests (for example, basophil histamine release/activation, lymphocyte stimulation, allergen‑specific IgG4, cytotoxicity assays, ALCAT) are considered not medically necessary or investigational and are excluded from coverage under this policy.
Policy revision history notes that tests previously labeled investigational were changed to not medically necessary as of 9/2023 during the annual review.
Coding — CPT/HCPCS Mappings and Code Status
| 86005 | Allergen specific IgE, multiple allergen screen (multiallergen IgE screening) |
| 95004 | Percutaneous tests (scratch, puncture, prick) with allergenic extracts, immediate. |
| 95017 | Percutaneous test; unlisted antigen, each. |
| 95018 | Percutaneous tests, intracutaneous (intradermal), sequential and incremental, with venoms, immediate type reaction, including 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). |
| 86003 | Allergen specific IgE; quantitative or semiquantitative, crude allergen extract, each. |
| 86008 | Allergen specific IgE; quantitative or semiquantitative, recombinant or purified component, each. |
| 82785 | Gammaglobulin (immunoglobulin); IgE (Total Serum IgE Testing e.g., PRIST/RIST). |
| 95018 | Percutaneous and intracutaneous allergy testing (various descriptions in policy text) |
| 95024 | Intracutaneous (intradermal) tests with allergenic extracts, immediate type reaction |
| 95027 | Intracutaneous tests, sequential and incremental, with allergenic extracts for airborne allergens, immediate reaction |
| 95028 | Intracutaneous tests with allergenic extracts, delayed type reaction, including reading |
| 95056 | Referenced extensively as mapping to multiple other codes/tests in policy |
| 95060 | Ophthalmic mucous membrane tests |
| 95065 | Direct nasal mucous membrane test |
| 95070 | Inhalation bronchial challenge testing (with histamine, methacholine, or similar compounds) |
| 95076 | Oral Food Challenge Test — initial 120 minutes of testing |
| 95079 | Oral Food Challenge Test — each additional 60 minutes |
| 0165U | Peanut allergen-specific IgE and quantitative assessment of 64 epitopes using ELISA, blood, individual epitope results |
| 0178U | Peanut allergen-specific quantitative assessment of multiple epitopes using ELISA, blood, report of minimum eliciting exposure |
| 86001 | Allergen specific IgG quantitative or semiquantitative, each allergen |
| 86005 | Allergen specific IgE; qualitative, multiallergen screen (eg, disk, sponge, card) |
| 86343 | Leukocyte histamine release test (LHR) |
| 95199 | Unlisted allergy/clinical immunologic service or procedure |
Provider Actions — Documentation, Prior Authorization, and Billing Guidance
Plan product and benefit application
This policy applies to Commercial products. Applicability to Medicaid/OHP and Medicare is described in the policy (Medicaid/OHP follow OHP rules when applicable; Medicare members may follow separate Medicare policy).
Prior authorization / documentation expectations (implied)
Prior authorization is not explicitly required in this section, but testing should be targeted to suspected allergens after an allergy-focused history and may require documentation to demonstrate medical necessity.
- Testing should be focused on foods or inhalants suspected of provoking the reaction and not be used as indiscriminate screening.
- Testing must be performed by personnel with appropriate competencies and facilities to manage anaphylaxis when skin testing is performed.
Annual frequency limits for allergy testing
The policy defines cumulative annual reimbursement limits for specified CPT code groups; providers should check benefits/prior authorization if limits may be exceeded.
- Percutaneous tests (95004, 95017, 95018): cumulative total of 70 per calendar year.
- Intracutaneous tests (95024, 95027, 95028): cumulative total of 40 per calendar year.
- Skin patch tests (95044): cumulative total of 80 per calendar year.
- Allergen-specific IgE serum tests for inhalant allergies (86003, 86008): cumulative total of 40 per calendar year.
- Allergen-specific IgE serum tests for food allergies (86003, 86008): cumulative total of 12 per calendar year.
Prior authorization for unlisted codes
Prior authorization is recommended for unlisted codes (e.g., 95199) or for potentially covered services submitted with unlisted codes to avoid post-service denial; unlisted codes are reviewed at claim level.
- All unlisted codes are reviewed for medical necessity, correct coding, and pricing at the claim level.
- Prior authorization is recommended to avoid post-service denial when an unlisted code is used for a potentially covered service.
Step therapy
No step therapy requirements are specified in this policy.
Preferred diagnostic sequence
Use validated tests (skin prick/puncture testing, serum allergen-specific IgE, and oral food challenge when indicated) before considering non-standard or unproven tests.
- Unproven or non-standardized tests are discouraged and listed as not medically necessary.
Preferred initial diagnostic modality
Skin testing (percutaneous/prick) is described as an ideal first-line investigation for IgE-mediated allergies due to high sensitivity and high negative predictive value; use serum sIgE when skin testing is unsafe or not possible.
- Perform skin testing when feasible; use serum allergen-specific IgE if the patient has widespread skin disease, cannot stop suppressive medications, cannot cooperate, or has high anaphylaxis risk.
Required clinical documentation
Clinical documentation of allergic or infectious symptoms is required to support in vitro allergy testing.
- Examples: urticaria, angioedema, ocular pruritus, wheezing, and/or anaphylaxis.
Documentation when skin testing is not possible
If skin testing is inconclusive or cannot be performed, document the specific reason (e.g., widespread skin disease, ongoing suppressive medication that cannot be stopped, inability to cooperate, or unusually high anaphylaxis risk).
- Acceptable reasons include dermatographia, generalized eczema, need for ongoing antihistamines or beta blockers that cannot be held, small child or inability to cooperate, or high anaphylaxis risk.
Clinical documentation expectations
Perform and document an allergy-focused history to justify testing; testing should be focused on suspected allergens and performed by qualified personnel with facilities to manage anaphylaxis when performing skin tests.
- Document the allergy-focused clinical history and the suspected allergens targeted for testing.
- Ensure personnel performing tests have appropriate competencies and emergency capabilities.
Frequency limit documentation
Documentation should support the number and type of tests billed and that they fall within the policy's annual frequency limits and code groups.
Documentation and coding details
Claims for allergy testing must specify the number of tests where indicated and will be reviewed for medical necessity, correct coding, and pricing; unlisted codes are subject to claim-level review.
- Provide test counts for CPTs that require 'specify number of tests' (e.g., intracutaneous and patch codes).
- Be aware that coding combinations may be subject to NCCI edits and MUEs.
Denial risk for unsupported in vitro testing
In vitro allergy testing is considered not medically necessary when the policy criteria for in vitro testing are not met (lack of clinical documentation of allergic/infectious symptoms or lack of documented skin test inconclusive/not possible), which may result in claim denial.
- Providers must meet both clinical symptom documentation and one of the skin test criteria to justify in vitro testing.
Denial risk for multiallergen IgE screening (86005)
Multiallergen IgE screening (CPT 86005) is listed as not medically necessary and may be denied if billed.
- Policy states multiallergen testing does not identify specific antigens and is considered not medically necessary.
Denial risk for unsupported tests
Tests listed as not medically necessary in the policy (e.g., ALCAT, applied kinesiology, IgG/IgG4 testing, leukocyte histamine release test, hair analysis, provocation-neutralization) are unsupported and may be denied.
- The policy lists a non-exhaustive set of tests considered not medically necessary and lacking sufficient evidence.
ALCAT/cytotoxic testing coding denial (83516)
When CPT 83516 is billed to represent ALCAT or cytotoxic food testing, it is considered not medically necessary per this policy and may be denied.
- 83516 is explicitly noted as being used to represent ALCAT/cytotoxic food testing and is considered not medically necessary in that context.
Denial risk for unlisted codes
If an unlisted code is submitted for non-covered services addressed in this policy, it will be denied as not covered.
- All unlisted codes are reviewed at claim level for medical necessity, coding, and pricing.
- Prior authorization is recommended when an unlisted code might represent a potentially covered service to avoid post-service denial.
Background and Evidence Summary
Allergic reactions are immune responses mediated by IgE to environmental or food allergens and can produce symptoms across multiple organ systems (skin, respiratory, ocular, gastrointestinal) and, in severe cases, trigger asthma exacerbations or anaphylaxis. Skin testing (prick/puncture, intradermal, patch) and serum allergen‑specific IgE measurement are standard diagnostic approaches; oral food challenges (DBPCFC) remain the diagnostic gold standard for food allergy when indicated.
Definitions — Key Test Types and Terms
Revision History and Policy Dates
Annual update — no changes to clinical criteria were made.
Annual update — no changes to clinical criteria; clarifying language added to billing guidelines.
Interim update — added note to billing guidelines; annual update with no changes to clinical criteria.
Investigational tests were reclassified as not medically necessary.
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