Allergy Testing (in vitro serologic and leukocyte-based tests) - Coverage Criteria
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Defines coverage and medical necessity for laboratory-based allergy tests (e.g., specific IgE assays, ELISA/Act, ALCAT, LHRT, IgG/IgG subclass testing) for BlueCHiP for Medicare and Commercial products in Rhode Island.
No material clinical or coverage changes in this revision.
Coverage determinations and medical necessity
Coverage determinations
Coverage stance varies by test and product; the following summarizes which in‑vitro allergy tests and CPT codes are considered covered/medically necessary and which are not covered or not medically necessary.
For BlueCHiP for Medicare, 86003 and 86008 are medically necessary when filed with the diagnosis codes in the attachment; Commercial Products list 86003 (and 86008 when filed with specified diagnosis codes) as medically necessary.
ALCAT is specifically not covered/not medically necessary when performed to establish a diagnosis of food allergy using the diagnosis codes listed in the Coding section; ALCAT panels may be billed with multiple units of 83516.
The following ICD-10 diagnosis codes are listed as Not Covered / Not Medically Necessary when associated with the CPT codes noted in this policy: K52.21–K52.29, Z91.010–Z91.018, Z91.02.
If services are determined to be not medically necessary or are a non-covered benefit, the provider may not bill the member unless the member was informed and provided written agreement in advance to pay. For member-specific benefit and eligibility questions, contact the provider call center; benefits are determined by the member's subscriber agreement or employer agreement and those documents supersede this policy.
The policy states that IgG and IgG subclass antibody tests for food allergy do not have clinical relevance, are not validated, lack sufficient quality control, and should not be performed. Additionally, the following tests are listed as not covered / not medically necessary due to insufficient evidence: Leukocyte Histamine Release Test (LHRT), IgG ELISA (indirect method), and the Qualitative multi-allergen screen. The Antigen Leukocyte Antibody Test (ALCAT) is also not covered/not medically necessary when performed to establish a diagnosis of food allergy and may be reported under CPT code 83516.
When tests or services are determined to be not covered or not medically necessary, claims may be denied and providers should not collect payment from members unless prior written agreement exists. Specific CPT codes associated with non-coverage or not medically necessary determinations include 86001, 86005, 86343, and 83516; these codes are identified in the policy as not covered for BlueCHiP for Medicare and not medically necessary for Commercial Products when filed with the listed diagnosis codes.
CPT and procedure code 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 |
What providers must do
Prior Authorization
Not applicable
Benefit Variability
Benefits may vary between groups and contracts. Refer to the member's Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable not medically necessary / not covered benefits and coverage.
Diagnosis Code Linkage for Medicare
The following CPT codes are considered medically necessary for BlueCHiP for Medicare when filed with the diagnosis codes in the referenced attachment: 86003, 86008. These codes may be used for ELISA/Act testing, IgG and IgG subclass antibody tests for food allergy, and LMRA by ELISA/Act.
Denial / Not Covered CPT Codes
The following CPT codes are not covered for BlueCHiP for Medicare and are not medically necessary for Commercial Products: 86001, 86005, 86343. In addition, CPT code 83516 is not covered for BlueCHiP for Medicare and not medically necessary for Commercial Products when filed with the listed diagnosis codes.
- 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
ICD-10 Codes Not Covered / Not Medically Necessary
ICD-10 diagnosis codes associated with not covered / not medically necessary determinations include: K52.21-K52.29, Z91.010-Z91.018, Z91.02. Verify applicable diagnosis coding when billing these services.
- K52.21-K52.29
- Z91.010-Z91.018
- Z91.02
Member Financial Responsibility and Eligibility Verification
Verify member benefits and eligibility by calling the provider call center for member-specific coverage determinations. If services are determined to be not medically necessary or not covered, providers may not charge the member unless the member is informed and provides written agreement in advance to accept financial responsibility. Refer to your participation agreement for additional billing limitations.
- Contact provider call center for member-specific benefits and eligibility
- Providers may not bill members for services determined not medically necessary or non-covered unless the member has provided written advance agreement
Clinical context and purpose
Allergy testing is intended to identify causative allergens and to guide management such as avoidance, pharmacotherapy, or allergen immunotherapy. Food allergy is typically IgE-mediated and requires clinical correlation with history and physical exam; non-immune-mediated food intolerance is better evaluated with elimination diets rather than serologic testing. The Antigen Leukocyte Antibody Test (ALCAT) is designed to detect leukocyte and platelet size/number changes after incubation with suspected agents, but its clinical utility is not established in the evidence cited.
Test definitions and assays
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