Allergy Testing (In Vivo and In Vitro) Coverage Criteria
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Defines coverage, medical necessity guidance, and coding/coverage stance for serum (in vitro) and skin (in vivo) allergy testing for Blue Cross Blue Shield - Rhode Island members across Medicare Advantage and commercial products.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
In Vitro Allergy Testing - Covered
Covered in vitro tests when filed with a covered diagnosis.
See Coding Section for diagnosis mapping and product-specific attachment.
In Vivo Allergy Testing - Covered with criteria
Intradermal and percutaneous (scratch/puncture/prick) testing coverage and medical necessity guidance.
Number and type of antigens must be related to history and exam; retesting with same antigens should rarely be necessary within three years.
Per policy: intracutaneous tests follow negative percutaneous testing.
Covered tests
Covered tests and applicable annual unit limits for Medicare Advantage Plans and Commercial Products.
Medicare Advantage and Commercial Products reference differing ICD-10 lists in the attachment.
Positive/negative control testing may not be included in reported units; number of tests must be specified and tied to clinical documentation.
This policy identifies several in vitro assays that are considered either not covered or not medically necessary because evidence is insufficient to demonstrate improved health outcomes. These include ELISA/Act qualitative antibody testing and LMRA (Lymphocyte Mitogen Response Assays) by ELISA/Act, both of which rely on in vitro lymphocyte responses and are not established as useful clinical diagnostics. The Leukocyte Histamine Release Test (LHRT) measures histamine release from basophils after allergen exposure but has insufficient diagnostic accuracy data to support routine use. The ALCAT (Antigen Leukocyte Antibody Test) measures changes in leukocyte size/number after exposure to food or environmental agents and is intended to identify intolerances rather than diagnose IgE-mediated food allergy. Finally, IgG ELISA indirect methods and qualitative multi-allergen screens are also listed among in vitro techniques for which the policy does not support routine diagnostic use.
Coding and coverage guidance specifies that CPT codes 86001, 86005, and 86343 are designated as not covered for Medicare Advantage and not medically necessary for Commercial Products. Additionally, CPT 83516 (used to report ALCAT panels) is not covered for Medicare Advantage and not medically necessary for Commercial Products when filed with the specified diagnosis codes (ICD-10 K52.21–K52.29). The policy also notes an unlisted immunology procedure (CPT 86849) may be used for tests without a specific CPT code.
If a service is determined to be a non-covered benefit or not medically necessary, providers should be aware of the financial and administrative consequences. The policy requires that providers may not charge the member for such services unless the member has been informed and has provided prior written agreement to continue at their own expense. Claims submitted for CPTs identified as not covered or not medically necessary (for example, CPTs noted above) are subject to denial per contract and coding rules.
The policy distinguishes appropriate uses and limitations of in vitro assays. Serum-based specific IgE testing by established methods (e.g., RAST/ELISA/FAST techniques reported with applicable CPTs) may be medically appropriate when linked to the patient’s clinical history and exam. By contrast, alternative or experimental in vitro tests—such as ELISA/Act qualitative tests, LMRA, LHRT, IgG indirect ELISA, qualitative multi-allergen screens, and ALCAT—are characterized in policy as having insufficient evidence to support diagnostic utility for food allergy or to show improved net health outcomes, and therefore are not covered or are considered not medically necessary as indicated.
Restating the policy position: LHRT, LMRA, ELISA/Act qualitative antibody testing for foods, ALCAT (reported using CPT 83516), and certain IgG and qualitative multi-allergen tests are considered not medically necessary or have insufficient evidence to support their routine use for diagnosing allergy or guiding management. ALCAT is described as intended to detect intolerances (not IgE-mediated allergy) and reports variable panel sizes; LHRT and LMRA lack adequate diagnostic accuracy data per the policy.
Services determined to be not medically necessary are subject to claim denial and related billing restrictions. Where CPT 83516 or other codes are identified as not covered/not medically necessary in the policy and are billed with restricted diagnosis codes, claims may be denied and providers are not permitted to seek payment from the member except with prior written consent.
Billing and CPT/Code Guidance
| ELISA/Act (Enzyme-linked Immunosorbent Assay/Advanced Cell Test) qualitative antibody testing (not covered / not medically necessary) | |
| LMRA (Lymphocyte Mitogen Response Assays) by ELISA/Act (not covered / not medically necessary) | |
| 86343 | Leukocyte Histamine Release Test (LHRT) / Leukocyte histamine release test (LHR) (not covered / not medically necessary) |
| 86001 | Allergen specific IgG quantitative or semiquantitative, each allergen (not covered / not medically necessary) |
| 86005 | Allergen specific IgE; qualitative, multiallergen screen (eg, disk, sponge, card) (not covered / not medically necessary) |
| IgG ELISA, indirect method (not covered / not medically necessary) | |
| Qualitative multi-allergen screen (not covered / not medically necessary) | |
| 83516 | Antigen Leukocyte Antibody Test (ALCAT) when performed to establish a diagnosis of food allergy — reported with CPT 83516 (not covered / not medically necessary when filed with specified diagnosis codes) |
| 95004 | Physician or qualified health care provider scratches, punctures, or pricks the skin to introduce specific allergy extracts; includes interpretation and report (examples of CPT codes reported based on number of individual tests performed) |
| 95017-95052 | Range of skin test CPT codes reported by number of tests performed (e.g., 95017, 95018, 95024, 95027, 95028, 95052) |
| 95018 | Percutaneous testing example (scratch/percutaneous and intradermal combined) — number reported equals number of allergens administered (example in guidance) |
| 95180 | Rapid desensitization kits — allergy testing is integral and not separately reportable (not separately reportable with immunotherapy) |
| 83516 | Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method — used for Antigen Leukocyte Antibody Test (ALCAT) (not covered / not medically necessary when filed with specified diagnosis codes K52.21-K52.29) |
| 86849 | Unlisted immunology procedure — may be used for any test identified in this policy that does not have a specific CPT code |
| 95004 | Percutaneous (scratch, puncture, prick) skin tests; includes interpretation and report |
| 95017 | Allergy testing, any, scratch/percutaneous — annual maximum: a total of 80 scratch, puncture, or prick allergy tests eligible for reimbursement per calendar year |
| 95018 | Allergy testing, any, scratch/percutaneous and intradermal combined — example guidance for number reported equals number of allergens administered (annual guidance varies by combination) |
| 95024 | Intracutaneous (intradermal) tests with allergenic extracts for airborne allergens, immediate type reaction, including interpretation — annual maximum: included in combined 40-unit maximum for intracutaneous codes |
| 95027 | Intracutaneous tests, sequential and incremental, with venoms, immediate type reaction, including interpretation — units and limits as specified in grid |
| 95028 | Intracutaneous (intradermal) tests with allergenic extracts, delayed type reaction, including reading — annual maximum: included in combined 40-unit maximum for intracutaneous codes |
| 95052 | Photo patch test(s) (specify number of tests) — annual maximum: a total of 36 photo tests eligible for reimbursement per calendar year |
| Chapter XI (90000-99999) | Reference to National Correct Coding Initiative Policy Manual for CPT codes 90000-99999 |
| A56844 | CMS Local Coverage Determination (LCD) article: Billing and Coding: RAST Type Tests referenced in policy (RAST-type tests billing/coding) |
Provider Responsibilities and Billing Actions
Prior authorization — Not applicable
Prior authorization is not applicable for allergy testing under this policy.
In vivo testing coverage and unit limits
In vivo (skin) testing CPT codes (e.g., 95004, 95017-95018, 95024, 95027-95028, 95052) are covered when performed according to policy guidelines; unit and annual maximums apply (80 scratch/puncture/prick tests per calendar year for 95017; a combined maximum of 40 intracutaneous tests per calendar year for 95024 and 95028; 36 photo tests per year for 95052).
- Percutaneous (scratch/puncture/prick) tests: total 80 tests eligible for reimbursement per calendar year (95017).
- Intracutaneous/intradermal tests: combined maximum of 40 units per calendar year for 95024 and 95028.
- Photo patch tests (95052): total 36 photo tests eligible for reimbursement per calendar year.
Verify member benefits and eligibility
Verify member benefits and eligibility prior to testing; benefits are determined by the member's subscriber or employer agreement and those documents supersede this policy.
- For member-specific benefit determinations, contact the provider call center as listed by BCBSRI.
- Subscriber/member certificate or employer agreement controls benefit coverage.
Sequencing requirement for intracutaneous testing
Providers must ensure intracutaneous (intradermal) allergy testing is performed only after negative scratch/puncture/prick testing when clinically indicated; report units consistent with policy guidance.
- "Intracutaneous allergy tests should only follow negative scratch, puncture or prick tests."
- Number and selection of tests must be related to patient history, physical findings and clinician judgment.
Required documentation to support medical necessity
Maintain complete medical necessity documentation in the patient record including patient history, physical examination, previous laboratory findings, current treatment plan, prescribed medications, and a risk assessment plan; documentation must justify the number and type of antigens/tests and be available to BCBSRI upon request.
- Patient history, physical exam, and prior laboratory findings.
- Current treatment plan and prescribed medications.
- Risk assessment plan and clinician rationale linking tests to history and exam.
- All documentation must be produced upon BCBSRI request; failure to do so may result in denial or retraction of payment.
Diagnosis code linkage required for covered IgE tests (86003, 86008)
CPT codes 86003 and 86008 are medically necessary for Medicare Advantage and Commercial Products only when filed with the diagnosis codes listed in the policy attachment; ensure correct ICD-10 linkage on claims.
- 86003 — Allergen specific IgE; quantitative or semiquantitative, crude allergen extract, each.
- 86008 — Allergen specific IgE; quantitative or semiquantitative, recombinant or purified component, each.
- File with the diagnosis codes specified in the referenced attachment to be considered medically necessary.
Benefit and eligibility verification — call for member-specific determinations
Contact the BCBSRI provider call center for member-specific determinations of benefits and eligibility; the member's subscriber agreement or employer agreement supersedes this policy.
- For member-specific benefits and eligibility, call the provider call center.
- Subscriber/employer agreement controls coverage determinations.
Documentation audit risk — produce records on request
BCBSRI may audit services and documentation; failure to produce requested documentation upon audit may result in denial of the claim or retraction of payment.
- BCBSRI maintains the right to audit services regardless of provider participation status.
- Failure to produce requested information may result in denial or retraction of payment.
Do not bill for tests identified as not covered / not medically necessary
Do not submit claims for CPT codes 86001, 86005, and 86343 for Medicare Advantage (not covered) or for Commercial Products (not medically necessary); CPT 83516 (used for ALCAT) is not covered for Medicare Advantage and not medically necessary for Commercial Products when filed with ICD-10 codes K52.21–K52.29. These tests are considered not medically necessary or lack sufficient evidence.
- 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 used for ALCAT (not covered / not medically necessary when filed with K52.21–K52.29).
Financial responsibility for non-covered or not medically necessary services
If services are determined to be not medically necessary or are non-covered benefits, the provider may not charge the member for those services unless the member has been informed and agreed in writing in advance to continue at their own expense.
- Providers should refer to participation agreements for applicable provisions regarding billing members.
- Obtain written member agreement before charging for non-covered or not medically necessary services.
Background and Scope
Background: allergy testing is performed to identify immunologic sensitivity to inhaled, ingested, injected, or contact agents. The policy differentiates in vivo (skin) testing—including percutaneous (scratch/prick) and intradermal techniques that directly assess IgE-mediated hypersensitivity—from in vitro serum-based tests that detect allergen-specific IgE antibodies. Skin testing is often preferred for immediate hypersensitivity evaluation but may be contraindicated in certain clinical scenarios; in vitro testing is used when skin testing is not feasible and should be interpreted in the context of the patient’s history and physical examination.
Definitions and Test Descriptions
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