Allergy Testing (in vivo and in vitro) Coverage Criteria
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Defines medical coverage and medical-necessity guidance for skin (in vivo) and serum (in vitro) allergy testing for Blue Cross Blue Shield of Rhode Island members (BlueCHiP Medicare and Commercial products).
No material clinical or coverage changes in this revision.
Coverage Criteria
Allergy testing - coverage conditions
All allergy testing (in vivo and in vitro) is covered when ALL of the following documentation and clinical requirements are met:
BCBSRI may audit documentation; failure to produce records may result in denial or retraction of payment.
In vitro testing - CPT-based coverage
In vitro (serum) testing is considered medically necessary when billed with an appropriate covered diagnosis and meets general coverage requirements:
ICD-10 diagnosis lists differ for Medicare vs Commercial products (see attachments).
Covered with criteria
Coverage and limitations for allergy testing codes
Specific IgG tests (86001), qualitative multiallergen screens (86005), leukocyte histamine release tests (86343), and certain immunoassays (eg, 83516/ALCAT) are listed as not covered/not medically necessary per the policy.
ELISA/Act (enzyme‑linked immunosorbent assay/Advanced Cell Test) qualitative antibody testing and IgG and IgG subclass antibody tests for food allergy are discussed in the policy as methods sometimes reported with covered in vitro CPTs, but the policy explicitly states these uses lack clinical relevance or validation and should not be performed. Documented examples include ELISA/Act qualitative methods and LMRA (lymphocyte mitogen response assays) referenced as potential uses of those assay codes, but the policy treats these methods with caution and limits their clinical application.
LMRA and other lymphocyte‑based assays are listed alongside ELISA/Act examples; the policy emphasizes that these methods are described in places as uses for the listed CPT codes but that specific IgG/IgG subclass testing for food allergy lacks sufficient validation and clinical relevance, and therefore should not be used to establish food allergy.
The policy identifies CPT codes 86001, 86005, and 86343 as not covered for BlueCHiP for Medicare and not medically necessary for Commercial Products. These codes correspond respectively to allergen‑specific IgG testing, qualitative multi‑allergen IgE screens (eg, disk/sponge/card), and leukocyte histamine release testing.
Providers should not bill these CPTs for BlueCHiP Medicare members or expect coverage for Commercial members, as claims using these codes are designated not covered/not medically necessary in the policy.
The policy lists several specific tests as not covered or not medically necessary because the evidence is insufficient to demonstrate meaningful effects on health outcomes: the Leukocyte Histamine Release Test (LHRT), the IgG ELISA indirect method, and the qualitative multi‑allergen screen. Additionally, the Antigen Leukocyte Antibody Test (ALCAT) is explicitly not covered/not medically necessary when used to establish food allergy.
Serum IgG and IgG subclass antibody testing for food allergy are specifically called out in the policy as lacking clinical relevance, not validated, and lacking sufficient quality control; as a result these methods are considered not covered/not medically necessary for the stated indications.
The policy references specific CPT/test pairings to clarify coverage stance and examples: 86001 (allergen‑specific IgG) is listed as not covered/not medically necessary; 86005 (qualitative multiallergen IgE screen, e.g., disk/sponge/card) is also not covered; and 86343 (leukocyte histamine release test) is not covered. The policy notes these CPTs are the mechanism by which the LHRT, IgG ELISA indirect, and qualitative multi‑allergen screens are reported.
The policy also comments on immunoassay methods such as ELISA/Act and LMRA: while these methods are described as possible assay approaches for in vitro testing, the document cautions that IgG and IgG subclass antibody tests for food allergy are not validated or clinically relevant and should not be used to establish food allergy.
Coding
| Leukocyte Histamine Release Test (LHRT) - not covered / not medically necessary | |
| IgG ELISA, indirect method - not covered / not medically necessary | |
| Qualitative multi-allergen screen - not covered / not medically necessary | |
| Antigen Leukocyte Antibody Test (ALCAT) - not covered / not medically necessary when performed to establish food allergy |
| ELISA/Act qualitative antibody testing - listed as an example use for 86003/86008 | |
| IgG and IgG subclass antibody tests for food allergy - described as not clinically relevant / should not be performed | |
| LMRA (Lymphocyte Mitogen Response Assays) by ELISA/Act - listed as example use for 86003/86008 |
| 83516 | Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method |
| 95004 | Scratch, puncture, or prick tests (percutaneous) |
| 95017 | Combination of percutaneous and intracutaneous testing |
| 95018 | Sequential and incremental testing with drugs or biologicals, immediate type reaction |
| 95027 | Intracutaneous tests, sequential and incremental, airborne allergens |
| 95024 | Intracutaneous tests with allergenic extracts (intradermal) |
| 95028 | Intracutaneous tests with allergenic extracts, delayed type reaction |
| 95044 | Application of patch tests |
| 95052 | Photo patch tests |
Provider Actions & Requirements
Prior Authorization
Not applicable.
Documentation audit risk
Blue Cross Blue Shield of Rhode Island may audit services provided to members. All documentation supporting medical necessity and services rendered must be available upon request. Failure to produce requested information may result in denial or retraction of payment.
Required clinical documentation
Medical Necessity documentation must be based on patient-specific clinical assessment and minimally include: patient history, physical examination and previous laboratory findings; current treatment plan; prescribed medication(s); and risk assessment plan. Providers must document the clinical rationale for the number and type of antigens/tests chosen.
Test counts and reporting
Coverage for skin and patch testing is subject to calendar-year unit limits. Providers must specify the number of tests when billing codes that require a test count (eg, CPT 95017, 95018, 95024, 95027, 95028, 95044, 95052). Units reported must reflect the actual number of tests performed and be supported in the medical record.
Non-covered tests trigger denial
Use of tests identified as not covered or not medically necessary (for BlueCHiP for Medicare and Commercial products) may result in claim denial. Examples include Leukocyte Histamine Release Test (LHRT), IgG ELISA indirect method, Qualitative multi-allergen screen, and Antigen Leukocyte Antibody Test (ALCAT) when used to establish food allergy. CPT codes 86001, 86005, 86343 and code 83516 (when filed with certain diagnoses listed in the policy) are not covered/not medically necessary.
Background
Allergy testing is divided into in vivo (skin) and in vitro (serum IgE) methods. In vivo testing (eg, scratch, puncture, intradermal, patch/photo patch) evaluates immediate‑type IgE‑mediated hypersensitivity at the skin level, while in vitro techniques (eg, RAST, FAST, ELISA) assess specific antibodies in the patient’s serum.
Testing should be guided by a complete history and physical examination; skin tests are used to evaluate IgE‑mediated responses, and patch/photo patch tests evaluate contact or photosensitivity. The policy emphasizes that the choice and number of antigens should be based on the patient’s clinical presentation and clinician judgment, and that retesting with the same antigens is rarely necessary within a three‑year period.
Definitions
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