Allergies, hypersensitive immune reactions to substances that are otherwise harmless, afflict one in six Americans. Substances which can trigger allergies are called antigens, and include such things as dust, molds, and pet dander. Symptoms range from mild irritation to life-threatening anaphylaxis. Medicare pays for the treatment of allergies through allergen immunotherapy, or allergy shots. In this therapy, a physician administers gradually increasing concentrations of an antigen in order to desensitize the patient. Treatment generally lasts from 3 to 5 years.

Antigen -A substance that can trigger an immune response. [AAAAI website]

Allergens are a type of antigen, which is any foreign substance which triggers an immune response, including substances which are universally harmful like pathogenic viruses and bacteria. Allergy symptoms range from mild irritation to anaphylaxis, a medical emergency involving an acute systemic allergic reaction.

Anaphylaxis is a serious allergic response that often involves swelling, hives, lowered blood pressure and in severe cases, shock. If anaphylactic shock isn't treated immediately, it can be fatal. A major difference between anaphylaxis and other allergic reactions is that anaphylaxis typically involves more than one system of the body. Symptoms usually start within 5 to 30 minutes of coming into contact with an allergen to which an individual is allergic. In some cases, however, it may take more than an hour to notice anaphylactic symptoms. Anaphylaxis may occur in people with allergies to foods, insect stings, medications or latex. (AAAAI website)

Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

1. Allergy immunotherapy is considered medically necessary for any one of the following indications:

• members whose symptoms are not controlled adequately by medications and avoidance measures;
• members who are experiencing unacceptable adverse effects of medications; or
• members who wish to reduce the long-term use of medications.

3. There is no evidence from well-designed studies that immunotherapy for any allergen is effective in the absence of specific IgE antibodies. Therefore allergen immunotherapy is not medically necessary in the absence of specific IgE antibodies.

4. Allergen immunotherapy for members with chronic urticaria, angioedema, or both is not medically necessary.

Medicare Coverage:
Per LCD L36240, Allergen Immunotherapy is covered for allergic rhinitis, allergic conjunctivitis, allergic asthma and stinging insect hypersensitivity when LCD L36240 criteria are met.

Treatment will not be reimbursed after a 2 year period when there is no apparent clinical benefit documented in the medical records.
Per NCD 110.9, Medicare does not cover Allergen Immunotherapy if the antigens are administered sublingually, i.e., by placing drops under the patient's tongue. This kind of allergy therapy has not been proven to be safe and effective.

Allergen immunotherapy is not indicated and is considered investigational for:

1. Food hypersensitivity
2. Urticaria and angioedema
3. Therapy with allergoids or adjuvants
4. Therapy Via Other administration:
o Oral or sublingual food immunotherapy
o Epicutaneous immunotherapy
o Intralymphatic immunotherapy
o Intranasal immunotherapy
o Sublingual Immunotherapy
5. Desensitization with commercially available extracts of poison ivy, poison oak, or poison sumac,
6. Desensitization for hymenoptera sensitivity using whole body extracts, with the exception of fire ant extracts
7. Desensitization with bacterial vaccine (BAC: bacterial, antigen complex, streptococcus vaccine, staphylo-streptovaccine, serobacterin, staphylococcus phage lysate)
8. Food allergenic extract immunotherapy
9. Intracutaneous desensitization (Rinkel Injection Therapy, RIT)
10. Intracutaneous titration
11. Neutralization therapy (intradermal and subcutaneous)
12. Repository emulsion therapy
13. Sublingual desensitization
14. Sublingual provocative therapy
15. Urine autoinjection (autogenous, urine immunotherapy)
16. Allergen immunotherapy for the management of skin and mucous membrane disease such as atopic dermatitis (rare exceptions as noted above reviewed in the appeals process), urticarial, and Candida vulvovaginitis
17. Intranasal immunotherapy
18. Postmortem examination for IgE antibodies to identify allergens responsible for lethal anaphylaxis (post mortem work is not covered by Medicare)

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[INFORMATIONAL NOTE: According to the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology, immunotherapy should not be given to members with negative test results for specific IgE antibodies or those with positive test results for specific IgE antibodies that do not correlate with suspected triggers, clinical symptoms, or exposure. This means that the presence of specific IgE antibodies alone does not necessarily indicate clinical sensitivity.

Immunotherapy begins with very small doses; increase progressively until maintenance levels are reached. Dosages vary depending on the type of standardization used. Individualize dosage. Up to 6 months supply in multi-dose vials may be prescribed for self administered injections once the member has been proven to tolerate the injections under medical supervision, without significant reaction and the patient/caregiver has been appropriately instructed in the proper administration and management of injections.

The following statements are excerpts from the Task Force Report of the Joint Task Force on Practice Parameters:

A. The preferred location of allergen immunotherapy administration is in the office of the physician who prepared the patient's allergen immunotherapy extract. The physician's office should have the expertise, personnel, and procedures in place for safe and effective administration of immunotherapy. However, in many cases it might be necessary to administer the allergen immunotherapy extract in another physician's office. Allergen immunotherapy should be administered with the same care wherever it is administered. A physician or qualified physician extender (nurse practitioner or physician's assistant) should be present and immediately available and be prepared to treat anaphylaxis when immunotherapy injections are administered.

B. Patients at high risk of systemic reactions (highly sensitive, severe symptoms, comorbid conditions, and history of recurrent systemic reactions), where possible, should receive immunotherapy in the allergist/immunologist's office.

C. Allergen immunotherapy should be administered in a medical facility with trained staff and medical equipment capable of recognizing and treating anaphylaxis. Under rare circumstances, when the benefit of allergen immnotherapy clearly outweighs the risk of withholding immunotherapy (eg, patients with a history of venom-induced anaphylaxis living in a remote region), at-home administration of allergen immunotherapy can be considered on an individual basis.

D. Home administration should only be considered in the rare circumstance when the benefit of immunotherapy clearly outweighs the risks. Frequent or routine prescription of home immunotherapy is not appropriate under any circumstances.]