Medical Policy: 02.01.01
Original Effective Date: April 1995
Reviewed: February 2020
Revised: February 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Allergic or hypersensitivity disorders can manifest themselves as generalized systemic reactions as well as localized reactions in any organ system of the body. Numerous agents, e.g., pollen, mold, dust mites, animal dander, insect stings, foods or drugs, may precipitate allergic or hypersensitive reactions. For details on coverage of allergy testing services, see Policy 02.01.02, Allergy Testing. For information on oral immunotherapy tablets see drug policy Oral Immunotherapy Policies: 05.01.110 Oralair, 05.01.111 Ragwitek, and 05.02.31 Odactra.
The management of an allergic patient should include a comprehensive history, physical examination and should include confirming the cause of allergies. Once the agent is identified, treatment is provided by avoidance, medication or immunotherapy.
Immunotherapy involves regular injections of offending allergens which are not readily avoidable. The treatment is provided over a period of months to years, with a goal of reducing symptoms. Allergy shots work like a vaccine. Your body responds to injected amounts of a particular allergen, given in gradually increasing doses, by developing immunity or tolerance to the allergen.
Allergoids: Allergoids are allergenic proteins that are treated with formaldehyde to produce larger molecules with decreased ability to react with IgE antibodies. Allergoids are licensed and manufactured for general distribution in Europe, but are not available in the United States.
There are two phases:
It would be the expectation that immunotherapy is based on symptom history and the results of allergy testing. The immunotherapy should be individualized to the needs of the patient. The immunotherapy dosages are expected to be personalized to the individual patient.
Immunotherapy should be discontinued in the maintenance phase when any of the following symptoms, or, signs of improvement is not experienced and all other reasonable factors have been ruled out:
Rush immunotherapy would be provided over only a few visits. The exact mechanism of action is not known but may involve an increase in allergen specific IgG antibodies, a decrease in IgE synthesis and alteration in T-lymphocyte activity.
Allergen-specific immunotherapy involves administering well-characterized allergen extracts, the potencies of which are measured and compared with a reference standard. An initial induction or build-up phase progressively increases the allergen dose; this is followed by multiple years of maintenance injections at the highest dose. Allergen-specific immunotherapy has been used to treat a variety of conditions including insect allergy, allergic rhinitis, and asthma. Subcutaneous injection of allergen-specific immunotherapy is the standard approach.
Intralymphatic immunotherapy is a new process of administering immunotherapy that is thought to increase the safety and convenience of prolonged immunotherapy. Allergen extract is injected into a lymph node under ultrasound guidance. Therapy is reported to be completed after 3 injections given on a monthly basis. This method of immunotherapy is currently being studied in clinical trials. The reason that ILIT appears to be effective in some studies but did not show efficacy in others might be related to the different outcome parameters. The parameters that signify efficacy are not straightforward.
Our mechanism of action aims to target specific epidermal dendritic cells, called Langerhans cells. Pre-clinical research has shown that these cells capture antigens and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream. The Viaskin® patch contains allergen protein in its original antigenic state, which allows the skin to be continuously exposed to the allergen over time. It is being studied in management of food allergies.
Allovate’s approach to allergy immunotherapy is built around the Allerdent® allergy therapeutic platform. The proprietary Allerdent® toothpaste base is designed to incorporate and stabilize immunotherapeutic agents used to treat allergies. The Allerdent® toothpaste base is available without active pharmaceutical agents. It can be customized by physicians.
Immunotherapy is effective for the treatment of allergic rhinitis, allergic conjunctivitis, allergic asthma, and stinging insect hypersensitivity. Clinical trials do not support the use of subcutaneous immunotherapy for food hypersensitivity. Oral immunotherapy and SLIT (sublingual immunotherapy) for food hypersensitivity/food allergies are considered investigational. Immunotherapy is not currently approved by the Food and Drug Administration for use to treat food allergy.
The risk of adverse reactions, including anaphylaxis. EAACI guidelines do not recommend food immunotherapy for routine clinical use. The conclusions of the position statement: Immunotherapy is effective in reducing symptoms of allergic asthma and rhinitis and potentially modifies the underlying course of disease. Studies on AIT in the treatment of AD and food allergy could broaden the indications. However, AIT remains underused because of a lack of awareness, limited access to specialist care, the reimbursement policy, long duration, and concerns regarding safety and effectiveness. The major barrier for the further development of immunotherapy, especially for the new technologies, is the capacity to perform 1 or more phase 3 confirmatory double-blind, placebo-controlled trials per allergen source.
In establishing the practice expense component for mixing a multidose vial of antigens, we observed that the most common practice was to prepare a 10 cc vial; we also observed that the most common use was to remove aliquots with a volume of 1 cc. Our PE computations were based on those facts. Therefore, a physician’s removing 10 1cc aliquot doses captures the entire PE component for the service.
This does not mean that the physician must remove 1 cc aliquot doses from a multidose vial. It means that the practice expenses payable for the preparation of a 10cc vial remain the same irrespective of the size or number of aliquots removed from the vial. Therefore, a physician may not bill this vial preparation code for more than 10 doses per vial; paying more than 10 doses per multidose vial would significantly overpay the practice expense component attributable to this service.
See Associated Policies: 02.01.02 for Allergy Testing. For information on oral immunotherapy tablets see Oral Immunotherapy Policies: 05.01.110 Oralair, 05.01.111 Ragwitek and 05.02.31 Odactra
Allergy immunotherapy is only recommended and considered medically necessary for:
Allergy immunotherapy is considered investigational for all other indications, including but not limited to:
Intralymphatic and Epicutaneous Immunotherapy are considered investigational.
Allergy therapy with Rapid Desensitization (also known as Rush or Cluster Desensitization process), in which the person would get an increased dosage over only a few days instead of over months or years, may be considered medically necessary only for patients with the following:
Rapid Desensitization for any other condition, including but not limited to food allergies and inhalant allergies is considered investigational.
Sublingual drop immunotherapy is considered investigational for all indications.
Oral mucosal immunotherapy compounds (eg toothpaste/Allerdent) is considered investigational.
Allergen-proof supplies, such as mattresses, pillows, and casings, etc., are considered personal convenience items and are not covered.
Per unit reimbursement for allergy immunotherapy is based on the number of dosages prepared and intended for administration. When billing, providers should report the number of units representing the number of 1cc doses being prepared. A maximum of 10 doses per vial is allowed.
Allergy immunotherapy, including insect immunotherapy, is limited to 120 units annually (this would equate to 12 pure allergen vial preparations that are then diluted and used for therapy) for the first year of therapy during escalation, and 90 units (which equates to 9 pure allergen vials) for yearly maintenance therapy thereafter.
There would not be a medical necessity to receive allergy immunotherapy through injections for grass allergies if oral immunotherapy tablets are also being utilized.
According to guidelines from the American Academy of Asthma, Allergy and Immunotherapy: allergen immunotherapy should be administered in a medical facility with trained staff and medical equipment capable of recognizing and treating anaphylaxis.
The administration of, and the provision of allergy serum for home immunotherapy (sometimes referred to as low dose immunotherapy) is considered a safety concern and not supported in guidelines, therefore it will be considered investigational.
Chemically modified allergen extracts (allergoids) are considered investigational. Currently allergoids are not approved for use in the United States.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.