Allergy testing (in vivo and in vitro) coverage policy
Customize your policy alerts
Sign up for all Blue Cross Blue Shield - Rhode Island policy alerts
Know when Blue Cross Blue Shield - Rhode Island releases new policies or updates existing guidance.
Monitor payer policy activity
Coverage policy for in vivo (skin) and in vitro (blood/serum) allergy testing for members of Blue Cross Blue Shield - Rhode Island, describing which tests are covered, not covered, and documentation/medical necessity expectations.
No material clinical or coverage changes in this revision.
Coverage criteria and test classifications
Coverage criteria and general medical necessity guidance
Covered when ALL of the following are met:
Medicare Advantage Plans and Commercial Products
Separate lists for Medicare Advantage Plans (not covered) and Commercial Products (not medically necessary)
Applies to Medicare Advantage Plans and Commercial Products
Applies to all allergy testing (in vivo and in vitro)
Coverage summary and unit limits
Coverage for in vitro and in vivo allergy testing is defined by specific CPT codes and subject to guideline-based performance and annual unit limits.
See ICD-10 diagnosis attachments for allowed diagnoses.
ALCAT and IgG/IgG-subclass testing lack clinical validation.
Intradermal delayed testing (95028) should only follow negative percutaneous (scratch/puncture/prick) tests.
Investigational / not established tests
Tests considered investigational / insufficient evidence
ALCAT specifically: 10% leukocyte size increase is cited by the test developer but diagnostic accuracy and clinical benefit are not established.
The following tests are identified in the policy as not covered / not medically necessary when used as described: ELISA/Act qualitative antibody testing, LMRA (Lymphocyte Mitogen Response Assays) by ELISA/Act, Leukocyte Histamine Release Test (LHRT), IgG ELISA (indirect method), and qualitative multi-allergen screens. These methods lack adequate evidence of clinical utility for diagnosing IgE-mediated allergy and therefore are not supported by BCBSRI for routine diagnostic use.
Allergen-specific serum IgE testing by validated quantitative or semiquantitative methods (CPT 86003 for crude extracts and CPT 86008 for recombinant/purified components) remain the covered in vitro options when filed with an allowed diagnosis and when medically indicated based on history and examination.
The Antigen Leukocyte Antibody Test (ALCAT) is explicitly identified as not covered / not medically necessary when used to establish a diagnosis of food allergy. ALCAT is reported in claims under CPT 83516 (immunoassay, qualitative/semiquantitative, multiple step method), and BCBSRI notes panels vary widely in size (reporting multiple units) and that the test is intended to detect leukocyte size/number changes rather than to diagnose IgE-mediated food allergy.
The policy describes the ALCAT methodology and threshold used by test manufacturers (a ~10% increase in leukocyte size as characteristic of a response) but concludes that available evidence is insufficient to support its diagnostic use for food allergy; therefore claims using CPT 83516 for ALCAT with the listed gastrointestinal or allergy-related diagnosis codes will be considered not covered/not medically necessary.
When a service is determined to be not medically necessary or is a non-covered benefit under the member’s plan, BCBSRI excludes that service from coverage. Providers may not bill or collect payment from the member for such services unless the member was informed and provided advance written agreement to accept financial responsibility.
Providers should maintain complete medical necessity documentation (history, physical exam, prior test results, treatment plan and risk assessment) and be prepared to produce it for audit. Failure to provide requested documentation upon audit may result in denial or retraction of payment.
Claims for CPT codes identified as not covered or not medically necessary (for example CPT 86001, 86005, 86343, and CPT 83516 when used for ALCAT) may be denied; providers should verify member benefits and obtain any required pre-service agreements before performing non-covered testing.
For Commercial Products BCBSRI lists the following specific tests as not medically necessary: ELISA/Act qualitative antibody testing, LMRA by ELISA/Act, Leukocyte Histamine Release Test (LHRT), IgG ELISA (indirect), and qualitative multi-allergen screens. These same tests are listed as not covered for Medicare Advantage Plans.
The policy further identifies CPT codes that correspond to tests the plan will not cover or considers not medically necessary, including CPT 86001 (specific IgG), CPT 86005 (qualitative multiallergen screen), CPT 86343 (LHRT), and CPT 83516 when used for ALCAT; claims filed with these codes are subject to denial per the policy.
BCBSRI characterizes LHRT, LMRA, ELISA/Act qualitative antibody testing, and IgG/IgG-subclass food antibody testing as having insufficient evidence to establish diagnostic accuracy or clinical utility; accordingly these tests are considered not medically necessary / not established for routine allergy diagnosis.
Specifically, LHRT measures histamine release from basophils in vitro but available studies are inadequate to permit conclusions about diagnostic accuracy, and LMRA (lymphocyte proliferation assays) lacks evidence supporting its use in allergy diagnosis. ELISA/Act qualitative methods and IgG/IgG-subclass testing are not FDA-approved or validated for diagnosing IgE-mediated food allergy, and BCBSRI therefore does not support their clinical use.
For in vitro testing that is supported, BCBSRI endorses quantitative/semiquantitative allergen-specific IgE assays (CPT 86003, 86008) when medically indicated and filed with covered diagnoses.
CPT codes, limits, and coding guidance
| 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 | Percutaneous allergy test (scratch/puncture/prick); immediate skin reaction documented; includes interpretation and report |
| 95017 | Allergy testing, any combination of percutaneous and intracutaneous, specify number of tests |
| 95018 | Allergy testing, percutaneous/intracutaneous with drugs or biologicals, immediate type, specify number of tests |
| 95024 | Intracutaneous (intradermal) immediate type reaction testing; includes interpretation and report |
| 95027 | Intracutaneous tests, sequential and incremental, with allergenic extracts for airborne allergens, immediate type |
| 95028 | Intracutaneous (intradermal) tests with allergenic extracts, delayed type reaction |
| 95052 | Photo patch test(s) (specify number of tests) |
| 95052 | Photo patch test(s) (specify number of tests). |
Provider actions, documentation, and billing warnings
No prior authorization required
Prior authorization is not applicable for allergy testing under this policy.
Follow unit limits and plan-specific coverage
Intradermal (CPT 95024, 95028) and combined percutaneous/intradermal testing are covered when performed per policy guidelines; intradermal codes 95024 and 95028 share a combined plan-specific annual maximum of 40 total units, and percutaneous tests (e.g., 95004/95017) have specified annual maximums (e.g., 80 units).
- Intradermal combined annual maximum: combined 40 units per calendar year for CPT 95024 and 95028 (regardless of distribution between immediate and delayed testing).
- Percutaneous tests (95004/95017) — examples in the grid: total of 80 scratch/puncture/prick tests eligible per calendar year; some grid entries list alternate annual maxima (e.g., 27 for certain 95017 entries).
- Positive/negative control tests may not be included in the number of tests reported.
Verify member benefits and authorization
Verify the member's benefits, eligibility and any authorization requirements with the provider call center before testing; the member’s subscriber or employer agreement governs coverage and supersedes this policy.
- For member-specific benefits, call the provider call center as noted in the policy.
- Benefits and eligibility are determined by the member's subscriber agreement or employer agreement and will supersede this policy.
Retesting interval — avoid routine annual retesting
Retesting with the same antigens should rarely be necessary within a three-year period; routine annual repetition of skin tests is not indicated.
- Retesting with the same antigens should rarely be necessary within a three-year period.
- Routine repetition (e.g., annually) is not indicated.
Sequential testing — intradermal only after negative percutaneous tests
Perform intradermal delayed testing (CPT 95028) only after negative scratch/puncture/prick testing; intradermal testing should be sequential following negative percutaneous tests.
- 95028 (intradermal delayed) should only follow negative scratch, puncture or prick tests.
- Sequential testing requirement: choose number/type of tests based on history and clinical judgment and follow percutaneous testing before intracutaneous when indicated.
Maintain required medical necessity documentation
Document medical necessity in the patient record with patient history, physical exam, previous laboratory findings, current treatment plan, prescribed medications, and a risk assessment plan; make documentation available for BCBSRI audit.
- Minimum documentation elements: patient history, physical examination, and previous laboratory findings.
- Also include current treatment plan, prescribed medications, and a risk assessment plan.
- All documentation must be available to BCBSRI upon request for audit.
Include test counts on claims and adhere to unit limits
Specify the number of tests on claims; intradermal testing CPTs 95024 and 95028 are subject to a combined annual maximum of 40 units and percutaneous codes have annual limits—claims must reflect units billed accordingly.
- Claims for in vivo testing must specify the number of individual tests performed.
- CPT 95024 and 95028 share a combined annual maximum of 40 units per calendar year.
- Percutaneous tests (e.g., CPT 95004/95017) have annual maximums (e.g., total 80 scratch/puncture/prick tests per calendar year or grid-specified alternatives).
Confirm member-specific benefits and eligibility
Confirm member-specific benefits and eligibility via subscriber/member certificate or employer agreement; contact the provider call center for plan-specific coverage questions.
- Benefits and eligibility are determined by the member’s subscriber agreement, member certificate, and/or employer agreement and supersede this policy.
- For information on member-specific benefits, call the provider call center as directed in the policy.
Documentation audit risk — retain records
Be prepared to produce requested documentation for BCBSRI review; failure to provide documentation upon audit may result in denial or retraction of payment.
- BCBSRI may audit services provided to members; all documentation must be available upon request.
- Failure to produce requested information may result in denial or retraction of payment.
Do not bill non-covered CPTs (86001, 86005, 86343, 83516/ALCAT)
Do not submit claims for CPT codes 86001, 86005, 86343 or CPT 83516 when used for ALCAT — these codes are listed as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.
- 86001 — Allergen specific IgG quantitative or semiquantitative, each allergen (not covered/not medically necessary).
- 86005 — Allergen specific IgE; qualitative multiallergen screen (not covered/not medically necessary).
- 86343 — Leukocyte histamine release test (LHR) (not covered/not medically necessary).
- 83516 — Immunoassay code used for ALCAT panels (not covered/not medically necessary when filed with listed diagnoses).
Do not bill members for non-covered or not medically necessary services without consent
If a service is determined to be not medically necessary or a non-covered benefit, you may not bill the member unless you have informed the member and obtained written agreement in advance.
- Services determined not medically necessary or non-covered may not be charged to the member except with prior written agreement.
- Refer to participation and subscriber agreements for applicable provisions.
Background and scope
Allergic disorders encompass immediate and delayed hypersensitivity reactions to inhaled, ingested, injected, or contact agents. The primary goal of diagnostic testing is to identify clinically relevant sensitivities that correlate with the patient’s history and physical exam so that targeted avoidance and therapy may be implemented.
Testing approaches include in vivo (skin) testing — percutaneous/prick, intradermal, and patch testing — which is often preferred for immediate-type hypersensitivity when feasible, and in vitro (serum) testing such as quantitative allergen-specific IgE (eg, ELISA or RAST) when skin testing is contraindicated or impractical.
Results from any testing modality must be interpreted in the context of the clinical presentation; tests without validated diagnostic accuracy (for example ALCAT, LHRT, LMRA, ELISA/Act qualitative, and IgG/IgG-subclass assays) should not be used as sole basis for diagnosis or immunotherapy decisions.
Definitions and test descriptions
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.