Allergy Immunotherapy

POLICY NUMBER

L.2.01.414

DESCRIPTION

Immunotherapy involves regular injections of an offending allergen over a period of months, with the goal of reducing symptoms. It begins with low doses to prevent unfavorable reactions, with gradually increasing doses injected once or twice a week as immunity to the antigen develops. After the maintenance dose is achieved, the interval between injections may range between two and six weeks. Immunotherapy may be administered continuously for several years.

Sublingual immunotherapy (SLIT) is a potential alternative to subcutaneous immunotherapy for providing allergen-specific therapy. It is proposed as a more convenient alternative delivery route for treating a variety of allergic disorders.

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. Due to the inconvenience of multiple injections, particularly in children, alternative delivery routes have been investigated; of these, sublingual immunotherapy (SLIT) is the most prominent. SLIT targets absorption to the sublingual and buccal mucosa. Allergen preparations used for SLIT are held under the tongue for one to several minutes and then swallowed or spit out.

POLICY

Immunotherapy is considered medically necessary in patients with demonstrated hypersensitivity that cannot be managed by medications or avoidance. Injections of airborne or insect venom allergens should be prepared for the patient individually.

Allergen immunotherapy should be paid by injection, not by dose. Provision of antigens for allergen immunotherapy will be paid by dose or vial, based on CPT descriptor.

The following methods are considered investigational and not covered:

• Provocative and neutralization therapy for food allergies, using intradermal and subcutaneous routes

• Sublingual

• Urine autoinjections (autogenous urine immunization)

• Repository emulsion therapy

Clinical ecology services may be billed as allergy services, and should be denied as investigational. These services involve the diagnosis and treatment of environmental illness, which is defined as multiple complex allergies or toxicities which are alleged to cause symptomatic involvement of the gastrointestinal, musculoskeletal, respiratory, or central nervous system. These symptoms result from continued exposure to atmospheric contamination or exposure to common foods which may have been treated with pesticides and herbicides.

Allergen-proof supplies, such as mattresses, mattress casings, pillows, pillow casings, air purification devices etc., should be considered personal convenience items and therefore are not medical in nature. These are routinely excluded as personal convenience items.

Examples of non-covered items considered to be used for environmental medicine/clinical ecology include but are not limited to:

• Barrier cloth cover for mattress

• Cold packs to keep antigens frozen

• Electric heater, mineral oil sealed, dimplex

• Half-mask respirator with organic vapor cartridges

• Housecleaning services

• Mold plates

• Portable air filter with air conditioner converter

• Rainbow^TM vacuum cleaner

• Syringes for antigen injections

• Water service

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Allergen immunotherapy should be paid by injection, not by dose. Provision of antigens for allergen immunotherapy will be paid by dose or vial, based on CPT descriptor.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

9/1992: Issued

2/1997: Medical Policy Advisory Committee approved revision to pay by injection

5/23/2001: Code reference section updated; ICD-9 diagnosis codes 117.3, 496.7 and 708.3 deleted.

2/14/2002: Investigational definition added

4/18/2002: Type of Service and Place of Service deleted

6/5/2002: Code Reference section updated

6/12/2002: "Rinkel, also known as serial dilution endpoint titration therapy for ragweed pollen hay fever" statement deleted. See Allergy Testing policy. ICD-9 diagnosis codes added 117.3, 692.73, 692.89, 693.9, 708.3

4/11/2003: Sources updated

8/1/2003: CPT code ranges 95120-95134, 95144-95170 listed separately, ICD-9 diagnosis code ranges 477.0-477.9, 692.0-692.6, 692.72-692.74 listed separately, Sources updated

11/3/2004: Code Reference section updated, CPT code 95117 description revised, CPT code 95180 added covered codes, ICD-9 diagnosis code 477.2, 692.84, E906.4 added covered codes, ICD-9 diagnosis code V15.0 5th digit added covered codes, ICD-9 diagnosis code 989.5 deleted covered codes

9/12/2006: Coding Updated.  ICD-9 2006 revisions added to policy

5/1/2008: Policy reviewed, no changes

9/30/2009: Code reference section updated. Code description revised for ICD9 diagnosis code V15.06. ICD-9 diagnosis code 995.2 deleted from covered table due to code is a deleted code as of 9-30-2006.

04/26/2010: Policy description revised to add information regarding sublingual immunotherapy (SLIT); however, this method remains investigational. Policy statement unchanged.

04/20/2011: Policy reviewed; no changes.

04/19/2012: Policy reviewed; no changes.

04/24/2013: Policy reviewed; no changes.

09/15/2014: Policy reviewed; no changes.

08/26/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 procedure code 99.12 from the Code Reference section.

10/07/2015: Code Reference section updated to add ICD-9 diagnosis code V07.1 and ICD-10 code Z51.89.

04/26/2016: Policy Guidelines updated to add medically necessary and investigative definitions.

06/06/2016: Policy number L.2.01.414 added.

09/30/2016: Code Reference section updated to add new ICD-10 diagnosis code Z51.6.

08/07/2023: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Sources updated.

08/20/2024: Policy reviewed; no changes.

10/01/2025: Code Reference section updated to add new ICD-10 diagnosis codes Z91.0110, Z91.0111, Z91.0112, Z91.0120, Z91.0121, and Z91.0122.

SOURCE(S)

1. BlueCross BlueShield of North Carolina. Allergy Immunotherapy (Desensitization) Medical Policy. Accessed 8/22/2023.

2. BlueCross BlueShield of Florida. Allergy Testing and Immunotherapy Medical Policy. Accessed 8/22/2023.

3. https://www.aaaai.org/tools-for-the-public/conditions-library/allergies/allergy-shots-(immunotherapy)

   . Accessed 8/21/2023.

4. Nowak-Wegryzn, A. (n.d.). Experimental therapies for food allergy: Immunotherapy and nonspecific therapies. UpToDate.

   https://www.uptodate.com/contents/experimental-therapies-for-food-allergy-immunotherapy-and-nonspecific-therapies?search=sublingual+immunotherapy&source=search_result&selectedTitle=2~27&usage_type=default&display_rank=2#H8

   . Accessed 8/8/2023.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.