CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Allergy Testing

Defines medical necessity, covered and not-covered allergy testing procedures (in vitro serum IgE tests, in vivo skin testing, and specific named tests such as ALCAT, LHRT, LMRA) for Blue Cross Blue Shield of Rhode Island Medicare Advantage and Commercial products, with CPT code coverage, annual unit limits, documentation expectations, and exclusions.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Allergy Testing

Policy CodePolicy N/A

Change Typeclarified

Effective DateApr 1, 2024

Next Review Date

Key ActionClinician must document patient-specific elements: physical exam and prior lab history/findings, prescribed medications, current treatment plan, and a risk assessment plan in the medical record to establish medical necessity.

SourceLink

POLICY UPDATE CHANGES

Policy lists covered CPT codes 86003 and 86008 when filed with covered diagnoses and enumerates not-covered tests including LMRA, IgG ELISA, LHRT, qualitative multi-allergen screen, and ALCAT for diagnosis of food allergy/intolerance.

2In vitro tests considered medically necessary (CPT)

5In vitro tests not covered / not medically necessary (named)

7In vivo CPT codes with explicit annual limits listed

Unlisted immunology procedure code noted

Coverage Summary

Scope: This policy defines medical necessity and coverage for allergy testing for Blue Cross Blue Shield of Rhode Island Medicare Advantage and Commercial products, covering both in vitro serum IgE assays and in vivo skin testing, and listing specific tests considered not medically necessary. Effective date: 04/01/2024. Policy last reviewed: 12/06/2023.

Coverage stance: Mixed — certain in vitro serum IgE tests (CPT 86003 and 86008) are covered when filed with a covered diagnosis; in vivo skin testing CPTs (including 95004, 95017, 95018, 95024, 95027, 95028, 95052) are covered with annual unit limits and when medically necessary per clinical judgment; the following named tests are considered not medically necessary / not covered due to insufficient evidence: ALCAT, LHRT (LHR), LMRA, IgG ELISA (indirect), qualitative multi-allergen screen (eg, CPT 86005).

Operational thresholds and limits

Retesting interval for skin testsRetesting with the same antigens should rarely be necessary within a three-year period

CPT 95004 annual units80 tests per calendar year

CPT 95017 annual units27 tests per calendar year

CPT 95018 annual units19 tests per calendar year

CPT 95027 annual units90 tests per calendar year

CPT 95024 annual units40 tests per calendar year

CPT 95028 annual units40 tests per calendar year

CPT 95052 annual units36 tests per calendar year

Medical Necessity Criteria

In Vitro (blood serum analysis) Allergy Testing - Covered Tests

Covered when filed with a covered diagnosis (see Coding Section). All other indications are not covered/not medically necessary:

ALL of the following

Allergen specific IgE; quantitative or semiquantitative, crude allergen extract, each (CPT 86003) is covered when filed with a covered diagnosis
Allergen specific IgE; quantitative or semiquantitative, recombinant or purified component, each (CPT 86008) is covered when filed with a covered diagnosis

In Vitro Testing - Not Covered / Not Medically Necessary

The following tests are not covered / not medically necessary as evidence is insufficient to determine effects on health outcomes:

ANY of the following

Coding

Covered CPT - In VitroCPTCovered

86003	Allergen specific IgE; quantitative or semiquantitative, crude allergen extract, each (covered when filed with a covered diagnosis)
86008	Allergen specific IgE; quantitative or semiquantitative, recombinant or purified component, each (covered when filed with a covered diagnosis)

Not Covered / Not Medically Necessary CPTCPTNot Covered

86001	Allergen specific IgG quantitative or semiquantitative, each allergen (not covered/not medically necessary)
86343	Leukocyte histamine release test (LHR/LHRT) (not covered/not medically necessary)
86005	Allergen specific IgE; qualitative, multi-allergen screen (eg, disk, sponge, card) (not covered/not medically necessary)
83516	Immunoassay for analyte other than infectious agent antibody or antigen; qualitative or semiquantitative, multiple step method (used for ALCAT) (not covered/not medically necessary when used to establish diagnosis of food allergy/intolerance)

In Vivo (Skin) Testing CPTs - Covered with Annual Unit LimitsCPTCovered

95004	Percutaneous (scratch, puncture, prick) testing; immediate skin reaction documented; Annual Maximum Allowed Units = 80; Units Explanation = total of 80 scratch/puncture/prick tests eligible per calendar year
95017	Combination percutaneous and intracutaneous, sequential and incremental, with venoms; includes interpretation and report; Annual Maximum Allowed Units = 27; Units Explanation = total of 27 tests per calendar year
95018	Combination percutaneous and intracutaneous, sequential and incremental, with or without biologicals; includes interpretation and report; Units Explanation = total of 19 tests eligible per calendar year
95027	Intracutaneous tests, sequential and incremental, with allergenic extracts for airborne allergens; Annual Maximum Allowed Units = 90; Units Explanation = total of 90 tests per calendar year
95024	Intracutaneous injection of suspected allergenic substances (immediate skin reaction); Annual Maximum Allowed Units = 40; Units Explanation = total of 40 intracutaneous tests eligible per calendar year
95028	Intracutaneous (intradermal) tests with allergenic extracts, delayed type reaction, including reading; Annual Maximum Allowed Units = 40; Units Explanation = total of 40 intracutaneous tests eligible per calendar year
95052	Photo test(s) (specify number of tests); Annual Maximum Allowed Units = 36; Units Explanation = total of 36 photo tests eligible per calendar year

Unlisted / OtherCPT

86849

Unlisted immunology procedure (can be used for any test identified in this policy that does not have a specific CPT code)

ALCAT Reporting / PanelsmixedNot Covered

ALCAT

Antigen Leukocyte Antibody Test - panels of various sizes; often reported with multiple units of CPT 83516; not covered/not medically necessary when used to establish diagnosis of food allergy/intolerance

Provider Actions

Documentation Required

Document clinical justification

Document patient-specific clinical justification in the medical record to establish medical necessity.

Patient physical examination and previous laboratory history/findings
Prescribed medication(s)
Current treatment plan
Risk assessment plan

Billing Rule

Report units based on number of individual tests (controls excluded)

Report CPT units equal to the number of individual tests actually performed; do not include positive or negative controls in the unit count.

Affected codes: 95004, 95017, 95018, 95024, 95027, 95028, 95052

Background and Evidence

Background: Allergy testing is divided into in vivo and in vitro modalities. In vivo (skin) testing includes percutaneous (scratch/puncture/prick), intracutaneous (intradermal), patch, and photo testing; these correlate cutaneous responses with history and physical exam and are used for evaluation of IgE-mediated hypersensitivity and photosensitivity disorders.

In vitro testing includes serum assays for allergen-specific IgE such as RAST/FAST and ELISA (including multiple antigen simultaneous techniques) to detect circulating IgE antibodies and help identify relevant allergens when correlated with clinical findings.

ALCAT is a blood test intended to assess leukocyte and platelet responses (changes in cell size/number measured by Coulter technique) to multiple food or environmental agents to guide elimination diets; it is not intended to diagnose food allergy. Evidence is limited with lack of diagnostic accuracy data and therefore insufficient to determine improvement in net health outcomes.

LHRT (leukocyte histamine release test) measures histamine release from basophils after in vitro allergen exposure. Earlier methods were labor-intensive; newer ELISA/radioimmunoassay approaches exist, but overall studies are insufficient to conclude diagnostic accuracy or clinical utility, and LHRT is considered not medically necessary.

LMRA (lymphocyte mitogen response assays) measure lymphocyte proliferation after stimulation in vitro; evidence is lacking to support their use for allergy diagnosis and they are considered not medically necessary.

Evidence conclusions

Evidence conclusion for ALCAT

Medicare Determinations

Name	Number	Type	Effective Date
RAST Type Tests	L33591	LCD

Revision History

2024-04-01effective_dateLatest

Policy effective date published as 04/01/2024; documents coverage, CPT codes, annual unit limits for in vivo testing, and documentation requirements.

2023-12-06last_review

Policy last reviewed on 12/06/2023.

2024-04-01operational_guidance_added

Operational guidance added for annual unit limits for specific in vivo CPT codes (e.g., 95004=80, 95017=27, 95018=19, 95027=90, 95024=40, 95028=40, 95052=36) and for documentation requirements that must be patient-specific and included in the medical record (patient physical exam and prior labs, prescribed medications, current treatment plan, risk assessment). This change is marked not material.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Allergy Testing

Policy CodePolicy N/A

Change Typeclarified

Effective DateApr 1, 2024

Next Review Date

SourceLink

On This Page

LMRA (Lymphocyte Mitogen Response Assays) by ELISA/Act

IgG ELISA, indirect method

Leukocyte Histamine Release Test (LHRT) / Leukocyte histamine release test (LHR) (CPT 86343)

Qualitative multi-allergen screen (CPT 86005)

Antigen Leukocyte Antibody Test (ALCAT) (reported using CPT 83516 or 86849/unlisted) when performed to establish a diagnosis of food allergy/intolerance

ELISA/Act qualitative antibody testing (Commercial Products section)

In Vivo (skin) Testing - Medical Necessity and Operational Rules

Intradermal and scratch testing is medically necessary when tests are chosen based on patient's clinical presentation and clinician judgment and are specific to patient's history and physical exam findings. Additional rules:

ALL of the following

Number of tests must be related to history, physical exam, and clinical judgment for each patient
Number and type of antigens used must be chosen judiciously based on presentation and tester's clinical judgment
Routine repetition of skin tests is not indicated; retesting with same antigens should rarely be necessary within a three-year periodRetesting interval: Retesting with the same antigens should rarely be necessary within a three-year period
Intracutaneous tests should only follow negative scratch/puncture/prick tests
CPT codes for testing and immunotherapy generally are not reported on the same date of service unless immunotherapy and testing for additional allergens are provided on the same day
CPT codes for allergen potency (safety) testing related to immunotherapy are not separately reportable; testing is integral to rapid desensitization kits (e.g., CPT 95180) and not separately reportable
In vivo CPT codes have specified annual unit limits (e.g., CPT 95004 = 80; 95017 = 27; 95018 = 19; 95027 = 90; 95024 = 40; 95028 = 40; 95052 = 36)See CPT-specific annual maximum allowed units in policy

Medical Necessity Documentation Requirements

Medical Necessity Guidance: documentation must be patient-specific and included in medical record

ALL of the following

Patient physical examination and previous laboratory history/findings
Prescribed medication(s)
Current treatment plan
Risk assessment plan

Positive and negative controls are excluded from the number of tests reported

Billing Rule

Testing and immunotherapy same-day billing restriction

CPT codes for testing and immunotherapy are generally not reported on the same date of service unless immunotherapy and testing for additional allergens are provided on the same day; allergen potency (safety) testing related to immunotherapy is not separately reportable and testing included in rapid desensitization kits is integral and not separately reportable.

Example referenced: CPT 95180 (rapid desensitization kits) — testing integral and not separately reportable

Denial Risk

Audit and documentation production

BCBSRI may audit provided services and require production of supporting documentation; failure to provide requested information may result in denial or retraction of payment.

Prior Authorization

Prior authorization not applicable

Prior authorization is not applicable for this policy; no prior authorization requirement is imposed.

Insufficient evidence to determine improvement in net health outcomes; lack of diagnostic accuracy data

Evidence conclusion for LHRT and LMRAStudies are not sufficient; considered not medically necessary due to insufficient diagnostic accuracy and clinical utility

Definitions / Glossary:

ALCAT — Antigen Leukocyte Antibody Test: a blood assay that assesses leukocyte/platelet changes in size and number after exposure to foods or environmental agents; used to guide elimination diets and not intended to diagnose food allergy.

LHRT / LHR — Leukocyte (basophil) Histamine Release Test: in vitro assay measuring histamine release from basophils after allergen exposure; evidence is insufficient and it is considered not medically necessary per this policy.

LMRA — Lymphocyte Mitogen Response Assays: in vitro tests measuring lymphocyte proliferation after activation stimulus; evidence is insufficient to support use for allergy diagnosis.