Allergy Testing — Coverage Criteria (in vivo and in vitro)
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This policy defines coverage, medical necessity guidance, and noncovered tests for allergy testing (skin and serum-based) for Medicare Advantage and commercial members of Blue Cross Blue Shield of Rhode Island.
No material clinical or coverage changes in this revision.
Coverage Criteria
Covered testing criteria
Covered when ALL of the following are met
Applies to Medicare Advantage and Commercial Products; see Coding section for covered CPT codes.
Medical necessity guidance
Documentation and test selection requirements
Number and type of antigens must be chosen judiciously and related to clinical findings; retesting with the same antigens should rarely be necessary within a three-year period.
Positive or negative control tests may not be included in reported test counts.
Medically necessary specific IgE testing
Medicare Advantage Plans and Commercial Products: CPT codes considered medically necessary when filed with specified diagnosis codes in attachments; other specific codes are not covered/not medically necessary.
Separate diagnosis code lists apply for Medicare Advantage and Commercial products per the policy attachments.
Not covered / Not medically necessary assays
The following assays are explicitly not covered or not medically necessary:
ALCAT panels may be reported with multiple units of CPT 83516 depending on panel size; ICD-10 diagnosis exclusions apply to CPT 83516 as listed in the policy.
Covered skin testing with limits
Skin testing CPT codes are covered when performed according to policy guidelines and within annual unit limits.
Units reported must reflect only patient antigen tests; follow sequencing requirement for intradermal testing.
The policy considers several nonstandard in vitro assays to be not covered / not medically necessary because the evidence is insufficient to demonstrate improved health outcomes. Specifically, the Antigen Leukocyte Antibody Test (ALCAT) is not covered when used to establish a diagnosis of food allergy, and related tests such as ELISA/Act qualitative antibody testing, LMRA by ELISA/Act, Leukocyte Histamine Release Test (LHRT), IgG ELISA (indirect method), and qualitative multi-allergen screens are likewise identified as lacking sufficient evidence to support clinical utility.
The following CPT codes are explicitly excluded from coverage or identified as not medically necessary: 86001 (allergen specific IgG, quantitative or semiquantitative), 86005 (allergen specific IgE; qualitative multiallergen screen), 86343 (leukocyte histamine release test), and 83516 (immunoassay, qualitative or semiquantitative, multiple step method — commonly used for ALCAT panels).
Specific tests identified as not covered or not medically necessary include: ALCAT (Antigen Leukocyte Antibody Test) when used to diagnose food allergy, LHRT (Leukocyte Histamine Release Test), LMRA (Lymphocyte Mitogen Response Assays by ELISA/Act), ELISA/Act qualitative antibody testing, IgG ELISA (indirect method), and qualitative multi-allergen screens. The policy cites insufficient or low-quality evidence and lack of demonstrated diagnostic accuracy or clinical benefit for these assays.
LMRA testing (Lymphocyte Mitogen Response Assays by ELISA/Act) and ELISA/Act qualitative antibody testing — including ALCAT-type approaches that rely on lymphocyte blastogenesis — are considered not established or of insufficient evidence to support clinical use for allergy diagnosis or management, and therefore are classified as not medically necessary.
Coding
| 95004 | Percutaneous tests (example code listed) — some allergy testing CPT codes reported based on number of individual tests |
| 95017-95052 | Range of skin testing CPT codes reported based on number of individual tests |
| 95018 | Percutaneous testing (example for reporting count of allergens) |
| 95180 | Rapid desensitization kits (allergy testing integral, not separately reportable) |
| 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) |
| 83516 | Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method |
| 86849 | Unlisted immunology procedure |
| 95004 | Scratch, puncture, or prick skin test, includes interpretation and report (Annual maximum allowed units = 80) |
| 95017 | Combination of percutaneous and intracutaneous tests with venoms, immediate type reaction, includes interpretation (Annual maximum allowed units = 27) |
| 95018 | Combination percutaneous and intracutaneous tests with drugs or biologicals, immediate type reaction, specify number of tests (Annual maximum allowed units = 19) |
| 95027 | Intracutaneous tests, sequential and incremental, with allergenic extracts for airborne allergens, immediate type reaction; number of tests must be specified (Example maximum annual units = 90) |
| 95024 | Injection of suspected allergenic substances into the skin (intradermal), immediate reaction, includes interpretation (Combined annual maximum for 95024 and 95028 = 40) |
| 95028 | Intracutaneous (intradermal) tests with allergenic extracts, delayed type reaction, including reading, specify number of tests (Combined annual maximum for 95024 and 95028 = 40) |
| 95052 | Photo patch test(s); specify number of tests (Annual maximum allowed units = 36) |
Provider Actions & Billing
Prior Authorization
Not applicable
Observe annual maximum units when filing
Certain skin testing CPT codes have annual maximum allowed units that must be observed when filing. Positive or negative control testing may not be included in the number of units reported.
- 95004 — Scratch/puncture/prick tests: Annual maximum allowed units = 80
- 95017 — Any combination percutaneous and intracutaneous with venoms: Annual maximum allowed units = 27
- 95018 — Any combination percutaneous and intracutaneous with drugs or biologicals: Annual maximum allowed units = 19
- 95027 — Intracutaneous tests for airborne allergens: Annual maximum allowed units = 90
- 95024 / 95028 — Intracutaneous tests: Combined annual maximum allowed units = 40 (e.g., 40 units for 95024, or 20 units 95024 AND 20 units 95028)
- 95052 — Photo patch tests: Annual maximum allowed units = 36
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Sequential testing requirement
Intracutaneous (intradermal) allergy tests should only be performed after negative scratch, puncture or prick tests (sequential testing requirement).
Required documentation elements
Medical necessity documentation must include patient history, physical examination, previous laboratory findings, current treatment plan, prescribed medications, and a risk assessment plan. Blue Cross Blue Shield of Rhode Island may audit services and requires all documentation to be available upon request.
- Include: patient history, physical exam, previous lab findings
- Include: current treatment plan and prescribed medications
- Include: documented risk assessment plan
- Retain and produce records upon audit to avoid denial or retraction of payment
Documentation audit risk
Failure to produce requested documentation upon audit may result in denial or retraction of payment.
Claim documentation for skin testing
Skin test services include interpretation and provider report. For intracutaneous tests, the number of tests must be specified on the claim. Observe the annual maximum units noted for each applicable CPT code when submitting claims.
Not covered codes trigger denial
The following CPT codes are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products: 86001, 86005, 86343. Use of these codes will trigger denial. Additionally, CPT 83516 is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products when filed with the specified diagnosis codes (used for ALCAT panels reported with multiple units).
- 86001 — Allergen specific IgG quantitative or semiquantitative, each allergen
- 86005 — Allergen specific IgE; qualitative, multiallergen screen
- 86343 — Leukocyte histamine release test (LHR)
- 83516 — Immunoassay for analyte other than infectious agent antibody or antigen; qualitative or semiquantitative, multiple step method (e.g., ALCAT panels)
Background
Allergic disorders can cause immediate (IgE-mediated) or delayed hypersensitivity reactions affecting multiple organ systems. Allergy testing includes in vivo skin-based methods — percutaneous (scratch/prick), intradermal (intracutaneous), and patch testing — and in vitro serum assays such as RAST/FAST/ELISA to detect allergen-specific IgE. Test selection should be guided by the patient history, physical examination, and clinical circumstances; nonstandard assays (e.g., ALCAT, ELISA/Act qualitative, LMRA, LHRT) are not supported by sufficient evidence and are not recommended for routine diagnostic use.
Definitions
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