This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

In vitro allergy testing for IgE may be considered medically necessary when ANY of the following are met:

• Direct skin testing is impossible due to an extensive dermatitis or marked dermatographism; or
• Direct skin testing is contraindicated because of concomitant drug treatment (e.g., psychotropic drugs frequently have H1 blocking characteristics); or
• When there is difficulty in testing uncooperative patients (e.g., small children or patients with mental or physical impairments); or
• If direct skin testing has been inconclusive; or
• As adjunctive tests for allergic bronchopulmonary aspergillosis or parasitic disease; or
• Individuals who have a clinical history suggesting an unusually greater risk for anaphylaxis or who have had a previous systemic reaction to skin testing; or
• For evaluation of cross-reactivity between insect venoms.

In vitro allergy testing for IgE exceeding 36 tests per year is considered not medically necessary.

In vitro allergy testing for IgE that does not meet the criteria of this policy is considered not medically necessary.

ELISA/ACT qualitative antibody testing is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

IgG ELISA, indirect method, is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

ALCAT (Antigen Leukocyte Cellular Antibody Test) allergy testing is considered experimental/investigational and, therefore, non-covered.  Scientific evidence does not demonstrate the usefulness of these tests.

Experimental/Investigational (E/I) services are not covered regardless of place of service.

In vitro allergy testing is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Quantity level limits or quantity of supplies that exceed the frequency guidelines listed on the policy will be denied as not medically necessary.

• Link to Provider Resource Center for the Medical Policy Update

11/2015, Facility Added to the In Vitro Allergy Testing Policy

• Link to References