CurrentCentenePolicy CP.MP.100

Allergy Testing and Immunotherapy

Defines medical necessity criteria, not medically necessary services, coding tables (CPT/ICD-10) and documentation requirements for allergy testing and allergen immunotherapy for Centene-affiliated health plans. Covers in vivo and in vitro testing, immunotherapy indications, limitations, training and billing guidance.

Policy Summary

PayerCentene

PolicyAllergy Testing and Immunotherapy

Policy CodePolicy CP.MP.100

Change TypeRevisions to coding and preparation criteria (historical additions/removals/clarifications)

Effective Date

Next Review Date

Key ActionDocument complete medical and immunologic history, test methodology and results, and periodically re-evaluate treatment benefits with re-evaluation at 3-5 years.

SourceLink

POLICY UPDATE CHANGES

Frequency limitations for allergy testing and treatment have been removed from this policy as they are based on state-specific guidelines; CMS NCCI MUE limitations apply in absence of state rules.

Added several CPT codes to not medically necessary list (86160, 86161, 86162, 86332, 86343, 86485, 86628, 0165U, 0178U).

Clarified that rapid desensitization is appropriate only for medication and hymenoptera sensitivities.

Added CPT codes 86160, 86161, 86162 to the medically necessary CPT code list with ICD-10 diagnosis linkage.

Removed CPT codes 86160, 86161, 86162 from the not medically necessary table.

Updated immunotherapy antigen preparation criteria requiring physician oversight and specific training/expertise.

Added ICD-10 codes (L20.0, L20.81-L20.83, L24.9, L30.2) to ICD-10 table 1 as medically necessary.

Added multiple codes to not medically necessary CPT Table 2 in 10/20 revision (86332, 86343, 86485, 86628, 0165U, 0178U etc.).

Coverage Summary

Scope: This policy covers both in vivo (skin-based: percutaneous/prick, intradermal, patch/photo tests, bronchial and ingestion challenges) and in vitro specific IgE testing for evaluation of immediate (IgE-mediated) and delayed (cell-mediated) hypersensitivity and defines medical necessity for allergen immunotherapy administered in a medical setting.

Status and key thresholds: Policy status is CURRENT. Retesting with the same antigen(s) should rarely be necessary within a 3-year period (with specified exceptions). Immunotherapy must show clinical benefit within 12–24 months; treatment will not be reimbursed after 2 years if no apparent benefit.

Immunotherapy indications and limits: Immunotherapy is indicated for patients with positive skin or serologic evidence of specific IgE to clinically relevant allergens causing allergic asthma, rhinitis/conjunctivitis, atopic dermatitis (when relevant), or life‑threatening insect sting allergy; rapid (rush) desensitization is limited to medication and hymenoptera sensitivities.

Training/compounding requirements: Antigens must be prepared by clinical staff under the direct oversight of the examining physician who has documented training and expertise in allergen immunotherapy (e.g., allergist, immunologist, otolaryngologist) and compounding personnel must meet AAAAI/ACAAI practice parameter and USP <797> aseptic compounding standards (written testing, media‑fill, gloved fingertip sampling, documentation).

Pharmacy benefit note: Non‑FDA approved sublingual immunotherapy is referenced to the pharmacy benefit for coverage criteria; only FDA‑approved SLIT products are endorsed per specialty guidance.

Operational thresholds

Retesting intervalRetesting with the same antigen(s) should rarely be necessary within a 3-year period; exceptions include children/adolescents with documented food allergy requiring follow up and certain children/adults with persistent symptoms.

Immunotherapy duration reviewClinical benefit should be evident within 12-24 months; treatment will not be reimbursed after 2 years if no apparent clinical benefit.

Unit limits / MUE ruleUnits allowed per year follow state-specific provider fee schedule; in absence of state rules, CMS Medicaid/Medicare NCCI MUE limitations apply.

Medical-Necessity Criteria

Medically Necessary Allergy Testing

Covered when ALL of the following are met:

ALL of the following

General clinical policy structure: Allergy testing must be performed as part of a complete diagnostic evaluation by a licensed practitioner acting within their scope of practice to perform allergy and immunology services; antigens tested should be reasonably possible for the member to be exposed to. Documentation must include complete medical/immunologic history, face-to-face exam, medical necessity, test methodology, measured results (mm for in vivo; kIU/L for in vitro), interpretation and plan of care, and periodic clinical evaluations as described in the policy.
Allowed test types
- Percutaneous testing (scratch, puncture, prick) (CPT 95004, 95017, 95018) for offending allergens such as pollen, molds, mites, dust, feathers, animal fur or dander, venoms, foods, or drugs.

Not Medically Necessary / Experimental Services

Coding

Medically Necessary CPT CodesCPTCovered

86003	Allergen specific IgE; quantitative or semiquantitative, crude allergen extract, each.
86005	Allergen specific IgE; qualitative, multiallergen screen (e.g., 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.
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).

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Not Medically Necessary CPT CodesCPTNot Covered

86001	Allergen specific IgG quantitative or semiquantitative, each allergen.
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 (individual epitope results and probability of peanut allergy).
0178U	Peanut allergen-specific quantitative assessment of multiple epitopes using ELISA; report of minimum eliciting exposure for a clinical reaction.

ICD-10 Codes supporting medical necessity (selected tables)ICD-10Covered

B44.81	Allergic bronchopulmonary aspergillosis.
H10.01*-H10.45	Conjunctivitis (ranges included where noted).
J30.0	Vasomotor rhinitis.
J30.1-J30.9	Allergic rhinitis (range included).
J31.0	Chronic rhinitis.
J45.2*-J45.998	Asthma (range included).
L20.0-L20.9	Atopic dermatitis.
L23.0-L23.9	Allergic contact dermatitis.
L25.1-L25.9	Unspecified contact dermatitis (range included).
L27.0-L27.9	Dermatitis due to substances taken internally (range included).

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ICD-10 Codes not supporting medical necessity for specific complement testsICD-10Not Covered

B44.81	Allergic bronchopulmonary aspergillosis.
H10.01*-H10.45	Conjunctivitis (ranges listed as not supporting 86160-86162).
J30.1-J30.9	Allergic rhinitis.
J45.2*-J45.998	Asthma.
L20.84-L20.89-L20.9	Atopic dermatitis codes included.
L23.0-L23.9	Allergic contact dermatitis.

Medically Necessary CPT codes (as updated)CPTCovered

86160	Complement; antigen, each component (added to medically necessary list when diagnosis code requirements are met).
86161	Complement; functional activity, each component (added to medically necessary list when diagnosis code requirements are met).
86162	Complement; total hemolytic (CH50) (added to medically necessary list when diagnosis code requirements are met).

CPT codes referenced as revised/deletedCPT

95070	Inhalation bronchial challenge testing (minor revision noted).
95071	Deleted in 2021 (historical reference).

ICD-10 codes added to medically necessary table 1 (examples listed in revisions)ICD-10Covered

J30.0	Added to ICD-10-CM Code Table 1 (03/21 revision).
L20.0	Added to ICD-10 code table 1 as medically necessary (05/22).
L20.81	Added to ICD-10 code table 1 as medically necessary (05/22).
L20.82	Added to ICD-10 code table 1 as medically necessary (05/22).
L20.83	Added to ICD-10 code table 1 as medically necessary (05/22).
L24.9	Added to ICD-10 code table 1 as medically necessary (05/22).
L30.2	Added to ICD-10 code table 1 as medically necessary (05/22).

Not Medically Necessary CPT codes (per historical revisions/Table 2)CPTNot Covered

86332	Immune complex assay (historically listed as not medically necessary, 10/20).
86343	Leukocyte histamine release test (historically listed as not medically necessary, 10/20).
86485	Skin test; candida (historically listed as not medically necessary, 10/20).
86628	Antibody; Candida (historically listed as not medically necessary, 10/20).
0165U	Peanut allergen-specific quantitative assessment (historically listed as not medically necessary, 10/20).
0178U	Peanut allergen-specific quantitative assessment (historically listed as not medically necessary, 10/20).
86160	Previously added to not medically necessary table (10/20) then moved per revisions.
86161	Previously added to not medically necessary table (10/20) then moved per revisions.
86162	Previously added to not medically necessary table (10/20) then moved per revisions.
86001	Added to not medically necessary CPT code table (09/22).

ICD-10 codes added to code tables historicallyICD-10

T88.6XXA	Added to ICD-10 code table 5 (01/19).
T88.6XXS	Added to ICD-10 code table 5 (01/19).
R06.2	Added to ICD-10-CM code table 1 (11/19 & 12/19 mentions).
Z88.0	Revised description in ICD-10 Tables 4 & 5 (10/20).
Z88.9	Revised description in ICD-10 Tables 4 & 5 (10/20).
Z91.010	Added to Tables 1 & 4 (10/20).
Z91.018	Added to Tables 1 & 4 (10/20).

Provider Actions & Billing Rules

Documentation Required

Required medical record documentation

Required medical record documentation for allergy testing, immunotherapy preparation, and administration. Documentation must demonstrate medical necessity, test methodology and results, interpretation, and follow-up care planning.

Complete medical and immunologic history and appropriate physical exam obtained by face-to-face contact with the patient
Medical necessity for performing the test or immunotherapy
Test methodology used (e.g., percutaneous, intradermal, in vitro, patch)
Measurement of reaction sizes (wheal and erythema) in mm for in vivo testing
Quantitative results in kIU/L for specific IgE (in vitro) testing
Interpretation of test results and how results will be used in the patient’s plan of care
Periodic clinical evaluation of treatment benefits; if no benefit within 12–24 months, consider other treatment options
Clinical re-evaluation at 3–5 years to determine need for continuing immunotherapy

Background & Evidence

Background — immediate vs delayed hypersensitivity and testing: The policy addresses immediate (IgE‑mediated) and delayed (cell‑mediated) hypersensitivity. In vivo testing includes percutaneous (prick/puncture) tests which remain the first‑line choice for immediate hypersensitivity because they are quick, safe and cost‑effective. Delayed hypersensitivity testing (patch testing) assesses T‑cell mediated contact reactions and requires careful technique.

Use of intradermal testing: Intradermal (intracutaneous) testing is used when percutaneous tests are negative but clinical suspicion remains high or when increased sensitivity is needed (e.g., inhalants, hymenoptera venom, select drugs). Skin end‑point titration (a variant of intradermal testing) can be used to determine starting immunotherapy doses for highly allergic patients.

Indications for in vitro testing: In vitro specific IgE testing (e.g., RAST, ELISA, ImmunoCAP; CPT 86003/86005/86008) is indicated in select circumstances — severe dermatographism/generalized eczema, increased anaphylaxis risk, inability to stop interfering medications (long‑acting antihistamines, tricyclics), uncooperative patients, negative/equivocal skin tests despite suggestive history, or for evaluating venom cross‑reactivity.

Training and aseptic compounding standards for extracts: Personnel preparing allergen extracts must demonstrate understanding of aseptic technique, pass written and annual media‑fill and gloved fingertip/thumb sampling tests, be re‑instructed/reassessed if failing, and maintain records of training and competency. Immunotherapy should be administered under physicians and in facilities equipped to manage anaphylaxis.

Evidence and guidance: Policy references AAAAI/ACAAI practice parameters and USP <797> compounding standards to define training and compounding expectations for extract preparation.

Practice parameter citations: Key supporting guideline citations include J Allergy Clin Immunol 2011 (Allergen immunotherapy practice parameter), the Ann Allergy Asthma Immunol 2008 practice parameter on allergy diagnostic testing, and the 2017 focused practice parameter update on sublingual immunotherapy.

Definitions

Term	Definition
Percutaneous testing
Scratch, puncture, prick skin tests for immediate type reactions (CPT 95004, 95017, 95018). Percutaneous testing is the first-line test for suspected immediate (IgE-mediated) hypersensitivity; requires medical supervision due to small but significant risk of anaphylaxis.
Rapid desensitization (rush immunotherapy)
Accelerated desensitization involving several injections over a short period (rush or cluster immunotherapy). Indicated only for medication allergies (e.g., insulin, penicillin, sulfonamides, cephalosporins) or hymenoptera venom sensitivities; requires strict physician monitoring and appropriate facility/equipment.
Non-FDA approved sublingual immunotherapy
Sublingual immunotherapy products not approved by the FDA (off‑label aqueous SLIT formulations); policy references pharmacy benefit for coverage criteria and notes AAAl/ practice guidance does not endorse non‑FDA SLIT formulations.

Medicare Determinations

Name	Number	Type
Local coverage determination: allergy testing
L34313 / L33417 / L33261 / L36402 / L32553 referenced
LCD

Revision History

06/17revised

Frequency limitations for allergy testing and treatment have been removed from this policy as they are based on state-specific guidelines; CMS NCCI MUE limitations apply in absence of state rules.

10/20added

Added multiple codes to not medically necessary CPT Table 2 (86160, 86161, 86162, 86332, 86343, 86485, 86628, 0165U, 0178U).

02/17clarified

Clarified that rapid desensitization is appropriate only for medication and hymenoptera sensitivities.

Policy Summary

PayerCentene

PolicyAllergy Testing and Immunotherapy

Policy CodePolicy CP.MP.100

Change TypeRevisions to coding and preparation criteria (historical additions/removals/clarifications)

Effective Date

Next Review Date

Key ActionDocument complete medical and immunologic history, test methodology and results, and periodically re-evaluate treatment benefits with re-evaluation at 3-5 years.

SourceLink

On This Page

Operational and utilization limits

Unit limitations for allergy testing and treatment are based on state-specific guidelines as defined in the provider fee schedule; in the absence of state-specific rules, CMS Medicaid/Medicare NCCI MUE limitations are applied.
Retesting with the same antigen(s) should rarely be necessary within a 3-year period; exceptions include children/adolescents with documented food allergy requiring follow up, young children with negative skin tests, or persistent symptoms despite prior negative testing.

Medically Necessary Allergen Immunotherapy (administered in medical facility)

Medically necessary when ALL of the following are met:

ALL of the following

Positive skin test or serologic evidence of an IgE-mediated antibody to the relevant allergen(s) for conditions such as allergic (extrinsic) asthma; dust mite atopic dermatitis; hymenoptera allergic reactions; mold-induced allergic rhinitis; perennial or seasonal allergic rhinitis or conjunctivitis.
Symptoms of allergic rhinitis or asthma after natural exposure to the allergen, or a life‑threatening allergy to insect stings (bees, hornets, wasps, fire ants).
Avoidance measures and/or pharmacologic therapy do not control allergic symptoms or the member has unacceptable side effects with pharmacologic therapy.
If rapid desensitization/rush immunotherapy is requested, it is medically necessary only for medication or hymenoptera (bees, hornets, wasps, fire ants) sensitivities.
Antigens are prepared by clinical staff directly overseen by the physician who examined the patient and who has training and expertise in allergen immunotherapy (e.g., allergist, immunologist, or otolaryngologist). Other specialties must provide evidence of expertise and training consistent with the AAAAI Allergen Immunotherapy Extract Preparation Instructional Guide.
See Background section for information on training requirements for immunotherapy preparation and administration. For FDA‑approved sublingual immunotherapy, refer to applicable pharmacy policy for coverage criteria.

Documentation Required

Immunotherapy supervision and facility requirements

Immunotherapy must be provided under appropriate physician supervision and in facilities prepared to manage systemic allergic reactions, including anaphylaxis. Compounding and preparation of allergen extracts must follow accepted standards.

Immunotherapy supervised by a physician trained in allergen immunotherapy (allergist, immunologist, or other specialist with documented expertise)
Facility must be equipped and staffed to recognize and treat anaphylaxis and other systemic reactions (e.g., emergency medications, resuscitation equipment, trained personnel)
Personnel compounding allergen extracts must follow applicable sterile compounding standards (e.g., USP <797>) and professional guidance such as the AAAAI/ACAAI Allergen Immunotherapy Extract Preparation Instructional Guide

Documentation Required

Training and supervision documentation for immunotherapy preparation

Documentation of training and supervision for staff preparing and compounding allergen immunotherapy extracts is required. Providers must either document staff training/competency or provide evidence of equivalent qualifications per specialty guidance.

Documented training and demonstrated competency in allergen extract preparation and handling for personnel involved in compounding
If personnel are not allergists/immunologists, provide evidence of equivalent training/expertise consistent with AAAAI/ACAAI instructional guidance

Prior Authorization

State-specific unit limits / Maximum Units per Encounter (MUE)

Unit limitations and maximum allowable units for allergy testing and treatments are determined by state-specific provider fee schedules. In the absence of state-specific limits, CMS NCCI/MUE unit limitations apply.

Unit limitations follow the state provider fee schedule where applicable
If no state-specific rules exist, the CMS Medicaid/Medicare NCCI MUE limitations are applied

Billing Rule

Ingestion challenge unit and reporting rule

Billing rules for ingestion (oral) challenge and related challenge procedures. Specific CPT codes are limited to once per patient encounter; inhalation bronchial challenge measurement rules apply to the listed codes.

CPT 95076, 95079, 95070 — allowed once per patient encounter
Inhalation bronchial challenge measurement: follow code-specific guidance for reporting and frequency

Denial Risk

Denial risk — Total IgE testing (CPT 82785)

Total serum IgE testing (CPT 82785) is appropriate only in select clinical situations. Routine or serial repeat testing without clear indication is subject to medical review and may be denied.

CPT 82785 is appropriate for evaluation of allergic bronchopulmonary Aspergillosis (ABPA)
Appropriate for select immunodeficiencies (e.g., hyper-IgE syndromes, recurrent pyogenic infections with supporting clinical history)
Appropriate when required for evaluation prior to initiating omalizumab (anti-IgE) therapy
Serial or repeat total IgE testing will be subject to medical review and may be denied if not clinically justified

Billing Rule

CPT/ICD-10 linkage for codes 86160–86162

CPT codes for specific immunoassays 86160–86162 require an appropriate ICD-10 diagnosis linkage. These tests are medically necessary only when diagnosis criteria in the policy’s ICD-10 tables are met.

CPT 86160 — Allergen-specific IgE testing (cross-reference to ICD-10 diagnosis requirements)
CPT 86161 — Allergen-specific IgE testing (cross-reference to ICD-10 diagnosis requirements)
CPT 86162 — Allergen-specific IgE testing (cross-reference to ICD-10 diagnosis requirements)
These codes are medically necessary only when the submitted ICD-10 diagnosis meets the policy’s required clinical indications

Billing Rule

Not medically necessary — Codes to not bill

The following codes and services are considered not medically necessary for allergy testing and immunotherapy and should not be billed. Reference the policy coding table and revision history for details.

CPT 86332 — Not medically necessary
CPT 86343 — Not medically necessary
CPT 86485 — Not medically necessary
CPT 86628 — Not medically necessary
CPT 0165U — Not medically necessary
CPT 0178U — Not medically necessary
CPT 86001 — Not medically necessary

Prior Authorization

Non‑FDA sublingual immunotherapy (pharmacy benefit referent)

Non-FDA approved sublingual immunotherapy products may fall under the pharmacy benefit. Prior authorization via the pharmacy benefit may be required; consult the applicable pharmacy coverage policy for authorization and coverage requirements.

Non-FDA sublingual immunotherapy is considered not medically necessary when provided as part of this benefit and may be managed under the pharmacy benefit instead
Pharmacy prior authorization may apply — check the member’s pharmacy benefit policy for coverage criteria and PA requirements