CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Allergy Testing — Coverage Criteria (in vivo and in vitro)

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.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyAllergy Testing — Coverage Criteria (in vivo and in vitro)

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateJan 1, 2024

Next Review DateOct 16, 2024

Key ActionFile allergen-specific IgE tests (86003, 86008) only with documented medical necessity including history, exam, prior labs and specified antigen selection.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Covered IgE test CPT codes listed

5Tests listed as not covered / not medically necessary

3Required documentation elements

80Annual max units (95004)

2Medically necessary CPT codes

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Coverage Criteria

Covered testing criteria

Covered when ALL of the following are met

General coverage: Allergen-specific quantitative or semiquantitative IgE testing (CPT 86003, 86008) is covered when filed with a covered diagnosis and the number and type of antigens selected are based on the patient's history, physical examination, and clinician judgment.

Applies to Medicare Advantage and Commercial Products; see Coding section for covered CPT codes.

Medical necessity guidance

Documentation and test selection requirements

Documentation: Testing must be supported by patient-specific medical necessity documentation that minimally includes: patient history, physical examination, prior laboratory findings, current treatment plan, prescribed medications, and a risk assessment plan. Records must be available for BCBSRI audit on request.

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.

Test selection and timing: The number of tests performed must be related to the history and physical findings for each patient. Intracutaneous (intradermal) tests should only follow negative percutaneous (scratch/prick) tests. Allergy testing is generally performed prior to immunotherapy; allergy testing CPT codes are not separately reportable when integral to rapid desensitization kits (CPT 95180).

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.

Covered serum specific IgE: CPT 86003 (allergen specific IgE; quantitative or semiquantitative, crude allergen extract, each) and CPT 86008 (allergen specific IgE; quantitative or semiquantative, recombinant or purified component, each) are considered medically necessary when filed with the diagnosis codes listed in the policy attachment.

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:

Not covered assays: CPT 86001 (allergen specific IgG, quantitative or semiquantitative), CPT 86005 (allergen specific IgE; qualitative, multiallergen screen), and CPT 86343 (leukocyte histamine release test) are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products. CPT 83516 (immunoassay; qualitative or semiquantitative, multiple step method) when used for ALCAT-type panels is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products when filed with the listed diagnosis codes (see ICD-10 exclusions). Unlisted immunology procedures may be reported with CPT 86849.

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.

Skin testing limits and sequencing: CPT codes 95004, 95017, 95018, 95024, 95027, 95028, and 95052 are covered when performed per policy guidance and with the annual maximum allowed units specified in the Coding/limits grid. Intracutaneous (intradermal) tests should only follow negative percutaneous (scratch/prick) tests. The number of tests must be specified on claims for intracutaneous procedures; positive or negative control tests may not be included in reported test counts.See coding thresholds (e.g., 95004 = 80 units/year; 95017 = 27 units/year; 95018 = 19 units/year; combined 95024/95028 = 40 units/year; 95027 example = 90 units/year; 95052 = 36 units/year)

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

Covered CPT CodesCPTCovered

86003	Allergen specific IgE; quantitative or semiquantitative, crude allergen extract, each (CPT code 86003)
86008	Allergen specific IgE; quantitative or semiquantitative, recombinant or purified component, each (CPT code 86008)

Referenced Allergy Testing CPT Codes / Reporting NotesCPT

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)

Medically necessary CPT CodesCPTCovered

86003	Allergen specific IgE; quantitative or semiquantitative, crude allergen extract, each
86008	Allergen specific IgE; quantitative or semiquantitative, recombinant or purified component, each

Not covered / Not medically necessaryCPTNot Covered

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

Unlisted immunology codeCPT

86849

Unlisted immunology procedure

Covered skin testing CPT codes with usage notes and limitsCPTCovered

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)

ALCAT positive change threshold

ALCAT positive change threshold10% increase in leukocyte size is considered characteristic of a response to an intolerant agent.

ALCAT purposeIntended to identify foods and other environmental agents for which an individual may have intolerance; not intended to diagnose food allergy.

Measurement methodChange in leukocyte and platelet size and number measured by Coulter technique after incubation with test agents.

Annual maximum units for 95004

95004 annual maximum units80 units per calendar year; a total of 80 scratch, puncture, or prick allergy tests are eligible for reimbursement per calendar year.

Provider Actions & Billing

Prior Authorization

Not applicable

Billing Rule

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

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

ALCAT definition — Antigen Leukocyte Antibody Test

DefinitionAntigen Leukocyte Antibody Test (ALCAT) is a blood test that assesses leukocyte and platelet response to foods and/or environmental agents by measuring change in cell size and number after exposure.

Intended useIntended to identify foods and environmental agents for which an individual may have intolerance; not intended to diagnose food allergy.

MethodologyBlood sample treated to remove red cells; baseline number and size of leukocytes/platelets measured, then incubated with test agents and remeasured (Coulter technique).

Percutaneous testing / Intradermal / Patch — definitions and intended uses

Percutaneous testing (scratch, puncture, prick)Used to evaluate IgE-mediated hypersensitivity; requires medical supervision due to small risk of anaphylaxis; test of choice for immediate hypersensitivity to inhalants, foods, hymenoptera, and some drugs.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyAllergy Testing — Coverage Criteria (in vivo and in vitro)

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateJan 1, 2024

Next Review DateOct 16, 2024

Key ActionFile allergen-specific IgE tests (86003, 86008) only with documented medical necessity including history, exam, prior labs and specified antigen selection.

SourceLink

On This Page

95004 includesTest interpretation and provider report; positive/negative control tests may not be included in units reported.

Type of testScratch/puncture/prick (percutaneous) skin test for immediate reactions.

Annual maximum units for 95017

95017 annual maximum units27 units per calendar year; a total of 27 tests filed under 95017 are eligible for reimbursement per calendar year.

95017 descriptionCombination of percutaneous and intracutaneous (intradermal), sequential and incremental, with venoms, immediate type reaction; includes interpretation.

Reporting noteUnits reflect number of individual tests; number chosen should be based on clinical findings.

Annual maximum units for 95018

95018 annual maximum units19 units per calendar year; a total of 19 tests filed under 95018 are eligible for reimbursement per calendar year.

95018 descriptionCombination of percutaneous and intracutaneous (intradermal) tests with drugs or biologicals, immediate type reaction; specify number of tests; includes interpretation and report.

Reporting noteNumber of tests must be specified on the claim when filing under 95018.

Annual maximum units combined limit for 95024 and 95028

Combined limit for 95024 and 9502840 intracutaneous allergy tests total per calendar year is the maximum allowed for codes 95024 and 95028 combined (e.g., 40 units for 95024 or 20 units for 95024 and 20 units for 95028).

95024 descriptionInjection of suspected allergenic substances into the skin (intradermal), immediate reaction; includes interpretation and provider report.

95028 descriptionIntracutaneous (intradermal) tests with allergenic extracts, delayed type reaction, including reading; specify number of tests.

Example maximum for 95027

Example maximum for 95027A total of 90 tests filed under 95027 are eligible for reimbursement per calendar year (example: 1 = intradermal/intracutaneous; 2 = 90).

95027 descriptionIntracutaneous tests, sequential and incremental, with allergenic extracts for airborne allergens, immediate type reaction; number of tests must be specified; includes test interpretation.

Claim requirementNumber of tests must be specified on the claim when filing under 95027.

Annual maximum units for photo tests (95052)

95052 annual maximum units36 photo tests per calendar year; a total of 36 photo tests are eligible for reimbursement per calendar year.

95052 descriptionPhoto patch test(s); specify number of tests.

Reporting noteNumber of photo tests must be specified when filing; units reflect individual photo patch tests.

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

Note

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Billing Rule

Sequential testing requirement

Intracutaneous (intradermal) allergy tests should only be performed after negative scratch, puncture or prick tests (sequential testing requirement).

Documentation Required

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

Denial Risk

Documentation audit risk

Failure to produce requested documentation upon audit may result in denial or retraction of payment.

Billing Rule

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.

Report number of intracutaneous tests when billing codes such as 95024, 95027, 95028
Skin test services include interpretation and provider report as part of the CPT code

Denial Risk

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)

Intradermal/Intracutaneous testing

Performed when increased sensitivity is needed (e.g., after negative percutaneous tests with strong clinical suspicion); injections into superficial skin layers; usually two concentrations (weaker and stronger) are used; not expected that 3+ concentrations are medically necessary.

Patch testingGold standard for identifying allergic contact dermatitis; indicated for nonspecific dermatitis or when contact allergy is likely; used for delayed type reactions.

LMRA definition — Lymphocyte Mitogen Response Assays

LMRA definitionLymphocyte Mitogen Response Assays (LMRA) by ELISA/Act measure the ability of lymphocytes to respond in vitro to an activation stimulus by isolating peripheral blood mononuclear cells and culturing with antigen to assess dividing cells.

Methodology requirementsRequires isolation of peripheral blood mononuclear cells and tissue culture with antigen; subsequent measurement of dividing cells indicates immune stimulation.

Evidence statementThere is a lack of evidence to support LMRA testing for diagnosis and treatment of allergies; evidence is insufficient to demonstrate clinical benefit.

Serum specific IgE tests / ELISA/Act / ALCAT — in vitro techniques

Serum specific IgE techniquesRAST/FAST and ELISA are in vitro techniques to detect specific IgE antibodies in serum; multiple antigen simultaneous tests can test several antigens at once.

ELISA/Act and related testsELISA/Act qualitative antibody testing is a variation used to determine in vitro reaction to foods relying on lymphocyte blastogenesis; it is not established as a useful clinical test.

Relation to ALCATALCAT-type assays also assess leukocyte responses in vitro but are not intended to diagnose food allergy; these nonstandard tests lack sufficient evidence for clinical use.