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.

Allergy immunotherapy may be considered medically necessary when ALL of the following criteria are met:

• An individual has ANY ONE of the following conditions:
  • asthma; or
  • Allergic rhinitis; or
  • Allergic conjunctivitis; or
  • Stinging insect allergy; or
  • Clinical evidence of an inhalant allergen sensitivity.

AND

• Documented skin test and/or serologic evidence of IgE-mediated antibody to a potent extract of the allergen (IgE) test; and
• Avoidance or pharmacologic therapy cannot control allergic symptoms or member has unacceptable side effects with pharmacologic therapy; and
• The individual's medical record documents the antigens to be administered, the treatment plan, and the dosage regimen. The regimen must include the starting immunotherapy schedule, target maintenance dose, and immunotherapy schedule.

Individuals must be evaluated every 6 to 12 months while receiving allergy immunotherapy for ALL of the following indications:

• To determine efficacy; and
• To determine whether adjustments in the dosing schedule or allergen content are necessary; and
• To ensure compliance; and
• To monitor for the two types of adverse reactions: local ( i.e., redness and swelling at the injection site) and systemic (i. e., sneezing, nasal congestion, or hives).

Allergy immunotherapy is considered not medically necessary after one year in the maintenance phase if ANY ONE of the following signs of improvement are not experienced, when all other reasonable factors have been ruled out:

• A noticeable decrease of symptoms; or
• An increase in tolerance to the offending allergen; or
• A reduction in medication usage.

Supervision of preparation and provision of single or multiple antigens for allergen immunotherapy may be considered medically necessary for a cumulative total of 120 doses/units per benefit period.

A dose is defined as the amount of antigen(s) administered in a single injection from a multiple dose vial.

Supervision of preparation and provision of single or multiple antigens for allergen immunotherapy represents single or multiple-dose vials of non-venom antigens. Common practice for mixing a multi-dose vial of antigens is to prepare a 10cc vial then remove 1-cc doses. Reimbursement may be made up to a maximum of 10 doses per vial.

Example: Use of code 95165

• If a physician uses 1/2 cc doses from a 10cc multiple-dose vial for a total of 20 doses, they should bill for no more than 10 doses.
• If a physician prepares two 10cc multi-dose vials and uses 1/2cc from one vial, and 1cc from the other vial, they should bill for no more than 20 doses.

Allergy immunotherapy is considered experimental/investigational and, therefore, not covered for ANY ONE of the following:

• Food Allergy; or
• Chronic Urticaria; or
• Angioedema.

See Medical Policy Bulletin Z-27 for information on Eligible Providers and Supervision Guidelines.

Refer to Pharmacy Policy Bulletin J-402 for information on Sublingual Immunotherapies.

Allergy Immunotherapy 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 non-covered. A network provider cannot bill the member for the non-covered service.

• Link to Provider Resource Center for the Medical Policy Update

02/2015, Correction January 2015 MPU: Allergy Immunotherapy Criteria Revised
06/2015, Supervision Of Preparation And Provision Of Single Or Multiple Antigens Clarified

• Link to Diagnosis Codes

• Link to References