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01-95000-01

Original Effective Date: 05/15/01

Reviewed: 10/24/14

Revised: 06/15/16

Subject: Allergy Testing and Immunotherapy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates  
           

DESCRIPTION:

Allergy is a form of exaggerated sensitivity or hypersensitivity, to a substance that is either inhaled, swallowed, injected, or comes in contact with the skin or eye. A reaction may be caused from exposure to pollens, dust, molds, mites, animal fur or dander, feathers, stinging insect venoms, foods, or drugs. The term allergy is used to describe situations where hypersensitivity results from heightened or altered reactivity of the immune system in response to external substances. Treatment typically consists of avoidance of the offending agent, medication or immunotherapy. Injections of airborne or insect venom allergens are prepared for the patient individually.

Allergy testing can be broadly subdivided into two methodologies:

In vivo testing – includes skin allergy testing (i.e., skin prick testing, skin scratch testing, intradermal testing, skin patch testing, and skin endpoint titration), bronchial provocation tests, and food challenges

In vitro testing – includes various techniques to test the blood for presence of specific IgE antibodies to a particular antigen (i.e., RAST and ELISA tests) and lelukocyte histamine release test (LHRT), also referred to as basophil histamine release test.

Allergy immunotherapy is the process of administering progressively increasing doses of an allergen as treatment for a person who has demonstrated sensitivity through allergy testing. The purpose of immunotherapy is to relieve the allergic symptoms by decreasing the reaction to the specific antigen. This clinical intervention has been used over the past 80 years. Immunotherapy begins with injections of the allergen extract (allergen vaccine) in low doses, with gradual increasing doses once or twice weekly as immunity to the antigen develops. Upon reaching a maintenance dose, injections are decreased to every two to six weeks, and may continue for several years.

POSITION STATEMENT:

 

Certificate of Medical Necessity

Submit a completed Certificate of Medical Necessity (CMN) along with your request to expedite the medical review process.

Click the link Allergy Testing - Certificate of Medical Necessity (MS Word) to open the form.

Complete all fields on the form thoroughly.

Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

Allergy Testing

The following allergy tests meet the definition of medical necessity when performed by or under the direct supervision of a physician for the purpose of establishing a diagnosis of allergy disease:

• Direct nasal mucous membrane test

• Ingestion challenge test (Ingestion challenge test has not been proven to be effective in the diagnosis of rheumatoid arthritis, depression, or respiratory disorders)

• Inhalation bronchial challenge testing with histamine, methacholine or similar compounds

• Intracutaneous (intradermal) tests, sequential and incremental with drugs, biologicals or venoms, immediate type reaction

• Intracutaneous (intradermal) tests, sequential and incremental with drugs, with allergenic extracts for airborne allergens, immediate type reaction

• Intracutaneous (intradermal) tests with allergenic extracts (allergen vaccine), immediate type reaction (i.e., serial endpoint titration/SET)

• Intracutaneous (intradermal) tests with allergenic extracts (allergen vaccine), delayed type reaction, including reading

• Ophthalmic mucous membrane test

Patch (application) tests with any membrane

• Percutaneous (scratch, puncture, prick) tests with allergenic extracts (allergen vaccine), immediate type reaction

• Percutaneous (scratch, puncture, prick) tests sequential and incremental, with drugs, biologicals or venoms, immediate type reaction

• Photopatch tests

• Photo tests

• Provocative testing (e.g., Rinkel test)

• Ingestion challenge test

In vitro testing for allergen specific IgG (except food allergy testing; see information below)

• In vitro testing for allergen specific IgE, which includes:

­ ELISA (enzyme linked immunosorbent assay)

­ FAST (Fluorescent allergosorbent test)

­ IP (Immuno-peroxidase test)

­ MAST (Multiple thread allergosorbent test)

­ RAST (Radioallergosorbent test)

­ PRIST (Paper radioimmunosorbent test)

­ CAP assay

• Ophthalmic mucous membrane test

• Patch (application) tests with any membrane

• Percutaneous (scratch, puncture, prick) tests with allergenic extracts (allergen vaccine), immediate type reaction

• Percutaneous (scratch, puncture, prick) tests sequential and incremental, with drugs, biologicals or venoms, immediate type reaction

• Photopatch tests

• Photo tests

• Provocative testing (e.g., Rinkel test)

Based on practice parameters and recommendations of the American College of Allergy, Asthma, & Immunology (ACAAI), the American Academy of Allergy, Asthma, & Immunology (AAAAI), and the Joint Council of Allergy, Asthma & Immunology (JCAAI) the following types of allergy testing are considered experimental or investigational as controlled studies have failed to demonstrate the value of these tests for the diagnosis of allergies in clinical practice. This is not an all-inclusive list.

• Antigen leukocyte cellular antibody (ALCAT) automated food allergy testing (This test is typically reported using CPT code 83516.)

• Cytotoxic testing for food, environmental or clinical ecological allergy testing

• Idiopathic environmental intolerance – any lab tests designed to affirm the diagnosis of idiopathic environmental intolerance;

• Ingestion challenge food testing for diagnosing rheumatoid arthritis, depression, or respiratory disorders not associated with anaphylaxis or similar systemic reactions

• Intracutaneous and subcutaneous provocative and neutralization testing for food allergies

• Mediator release test (MRT) or the LEAP Program, in which the Mediator Release Test (MRT) is used to identify "delayed food allergies"; treatment involves dietary manipulation and possibly supplements and/or herbs;

• Nutritional assessments, including intracellular analysis of micronutrients in asymptomatic individuals and individuals with symptoms suggestive of idiopathic environmental intolerance.

• SAGE testing for food delayed sensitivity

• Serum IgG assays and IgG subclass assays for testing food or environmental allergies (e.g., Immuno 1 Bloodprint™; AllergySmarts Food Intolerance Testing; foodSCAN IgG ELISA Food Intolerance Test). There is insufficient evidence in the published peer-reviewed scientific literature to support the argument that IgG antibodies are responsible for delayed food allergic symptoms, or intolerance to specific foods, or environmental intolerances.

• Sublingual provocative testing for food allergies.

Routine allergy re-testing does not meet the definition of medical necessity according to the practice parameters and recommendations of the American College of Allergy, Asthma, & Immunology (ACAAI), the American Academy of Allergy, Asthma, & Immunology (AAAAI), and the Joint Council of Allergy, Asthma & Immunology (JCAAI).

Allergen Immunotherapy

Allergen immunotherapy by intradermal or subcutaneous injection meets the definition of medical necessity when administered for the treatment of patients demonstrating hypersensitivity to specific antigens that cannot be managed by medications or avoidance.

Allergen immunotherapy services may include one or more of the following:

• Patient evaluation related to the supply or administration of the allergenic extract (allergen vaccine)

• Supplies (needles, syringes, diluents)

• Monitoring the physical status of the patient during administration of the extract (allergen vaccine.)

Professional services for allergen immunotherapy may include A and B, A or B, or C below:

A. Administration of the allergenic extract(s) (allergen vaccine) only, not including the provision (supply) of the extract(s) (allergen vaccine) (95115, 95117)

B. Supervision, preparation and provision (supply) of extract(s) (allergen vaccine) only (95144, 95145 – 95149, 95165, 95170)

C. Administration and provision (supply) of extract(s) (allergen vaccine) (95120, 95125, 95130 – 95134.)

Based on the guidelines of the American Academy of Allergy, Asthma, and Immunology (AAAAI), extracts (vaccines) with high proteolytic enzyme activities (e.g., fungi, dust mites, cockroach, and insect venoms) are separated from those without proteolytic enzyme activities. Therefore, patients should typically require only two (2) vials of allergen extract(s). Any excess of three (3) multi-dose vials would be subject to review by the Medical Director.

Environmental therapy, also known as idiopathic environmental intolerance or clinical ecology treatment, does not meet the definition of medical necessity as there is insufficient peer-reviewed medical literature to support these therapies as being any more effective than the standard care for treatment. Available published literature suggests ongoing controversy regarding the etiology of the condition, appropriate diagnostic criteria, and treatment strategies.

This method of therapy may include the following:

• Aerobic exercise therapy

• Alteration of the patient's household environment

• Avoidance therapy

• Elimination diet

• Environmental care units

• IVIg

• Massages

• Neutralizing therapy of chemical and food extracts

• Nutritional therapy

• Physical therapy

• Rotation diets

• Vaccine therapy.

Sublingual immunotherapy (SLIT) using Oralair®, Grastek®, or Ragwitek® as a technique of allergy immunotherapy does not meet the definition of medical necessity. Clinical trials have not been reported comparing SLIT with the standard subcutaneous injection immunotherapy (SCIT). These comparisons are needed to adequately evaluate SLIT.

Urine autoinjection, (autogenous urine immunization), an allergy treatment, is not proven to be safe or effective and is considered experimental or investigational as there is insufficient peer-reviewed medical literature to support the safety and effectiveness of this therapy.

BILLING/CODING INFORMATION:

CPT Coding for allergy testing:

86001

Allergen specific IgG quantitative or semiquantitative, each allergen (investigational)

86003

Allergen specific IgE; quantitative or semiquantitative, each allergen

86005

Allergen specific IgE; quantitative, multi-allergen screen (dipstick, paddle, or disk)

95004

Percutaneous tests (scratch, puncture, prick) with allergenic extracts, immediate type reaction, including test interpretation and report, specify number of tests

95017

Allergy testing, any combination of percutaneous (scratch, puncture, prick) and intracutaneous (intradermal), sequential and incremental, with venoms, immediate type reaction, including test interpretation and report, specify number of tests

95018

Allergy testing, any combination of percutaneous (scratch, puncture, prick) and intracutaneous (intradermal), sequential and incremental, with drugs or biologicals, immediate type reaction, including test interpretation and report, specify number of tests

95024

Intracutaneous (intradermal) tests with allergenic extracts, immediate type reaction, including test interpretation and report by a physician, specify number of tests

95027*

Intracutaneous (intradermal) tests, sequential and incremental, with allergenic extracts for airborne allergens, immediate type reaction, including test interpretation and report, specify number of tests

95028

Intracutaneous (intradermal) tests with allergenic extracts, delayed type reaction, including reading, specify number of tests

95044

Patch or application test(s) (specify number of tests)

95052

Photo patch test(s) (specify number of tests)

95056

Photo tests

95060

Ophthalmic mucous membrane tests

95065

Direct nasal mucous membrane test

95070

Inhalation bronchial challenge testing (not including necessary pulmonary function tests); with histamine, methacholine, or similar compounds

95071

Inhalation bronchial challenge testing (not including necessary pulmonary function tests); with antigens or gases, specify

95076**

Ingestion challenge test (sequential and incremental ingestion of test items, e.g., food, drug or other substance); initial 120 minutes of testing

95079**

Ingestion challenge test (sequential and incremental ingestion of test items, e.g., food, drug or other substance); each additional 60 minutes of testing (List separately in addition to code for primary procedure)

Coding Notes:

*95027 – Since more than one dilutional test per antigen is performed, the number of tests, rather than the number of antigens, should be reported. Example: Ten allergens with six dilutional tests would be reported as sixty units. Test interpretation and report by a physician must also be performed to report this code.

**95076 is reported only once per patient encounter, regardless of the number of items tested and includes evaluation of the patient’s response to the test item(s) (95079 is an add-on code that is never reported alone).

CPT Coding for Allergy Immunotherapy:

95115

Professional services for allergen immunotherapy not including provision of allergenic extracts; single injection

95117

Professional services for allergen immunotherapy not including provision of allergenic extracts; 2 or more injections

95120

Professional services for allergen immunotherapy in the office or institution of the prescribing physician or other qualified health care professional, including provision of allergenic extract; single injection

95125

Professional services for allergen immunotherapy in the office or institution of the prescribing physician or other qualified health care professional, including provision of allergenic extract; 2 or more injections

95130

Professional services for allergen immunotherapy in the office or institution of the prescribing physician or other qualified health care professional, including provision of allergenic extract; single stinging insect venom

95131

Professional services for allergen immunotherapy in the office or institution of the prescribing physician or other qualified health care professional, including provision of allergenic extract; 2 stinging insect venoms

95132

Professional services for allergen immunotherapy in the office or institution of the prescribing physician or other qualified health care professional, including provision of allergenic extract; 3 stinging insect venoms

95133

Professional services for allergen immunotherapy in the office or institution of the prescribing physician or other qualified health care professional, including provision of allergenic extract; 4 stinging insect venoms

95134

Professional services for allergen immunotherapy in the office or institution of the prescribing physician or other qualified health care professional, including provision of allergenic extract; 5 stinging insect venoms

95144

Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy, single or multiple antigens, single dose vials (specify number of vials)

95145

Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); single stinging insect venom

95146

Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 2 single stinging insect venoms

95147

Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 3 single stinging insect venoms

95148

Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 4 single stinging insect venoms

95149

Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 5 single stinging insect venoms

95165

Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses)

95170

Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); whole body extract of biting insect or other arthropod (specify number of doses)

95180

Rapid desensitization procedure, each hour (e.g., insulin, penicillin, equine serum)

95199

Unlisted allergy/clinical immunologic service or procedure

Coding Notes:

There is no specific procedure code for reporting sublingual immunotherapy (SLIT).

Allergen immunotherapy services may include one or more of the following:

• Patient evaluation related to the supply or administration of the allergenic extract (allergen vaccine)

• Supplies (needles, syringes, diluents)

• Monitoring the physical status of the patient during administration of the extract (allergen vaccine.)

Professional services for allergen immunotherapy may include A and B, A or B, or C below:

A. Administration of the allergenic extract(s) (allergen vaccine) only, not including the provision (supply) of the extract(s) (allergen vaccine) (95115, 95117)

B. Supervision, preparation and provision (supply) of extract(s) (allergen vaccine) only (95144, 95145 – 95149, 95165, 95170)

C. Administration and provision (supply) of extract(s) (allergen vaccine) (95120, 95125, 95130 – 95134).

REIMBURSEMENT INFORMATION:

Reimbursement for allergy testing services includes the following components:

• Supplies (e.g., sterile diluents, syringes, needles)

• Monitoring the physical status of the patient during testing

• Observation, recording, and interpretation of the test results.

Reimbursement for allergy testing is based on the number of each type of test performed by the same physician and is subject to the following limitations when the above coverage criteria are met:

Limitations:

Cpt Code:

Type of Test:

Limited To:

86005

Allergen specific IgE; qualitative, multiallergen

1 per year

95004

Percutaneous tests (scratch, puncture, prick) with immediate type reaction

400 in 12 months

95017

Allergy testing with venoms; any combination of percutaneous (scratch, puncture, prick) and intracutaneous (intradermal) testing

120 in 12 months

95018

Allergy testing with drugs and biologicals; any combination of percutaneous (scratch, puncture, prick) and intracutaneous (intradermal) testing

120 in 12 months

95024

Intracutaneous (intradermal) tests with allergenic extracts, immediate type reaction

120 in 12 months

95027

Intracutaneous (intradermal) tests, sequential and incremental, with allergenic extracts for airborne allergens, immediate type reaction

120 in 12 months

95028

Intracutaneous (intradermal) tests with allergenic extracts, delayed type reaction

120 in 12 months

95044

Patch or application test(s)

200 in 12 months

95052

Photo patch test(s)

200 in 12 months

95056

Photo tests

200 in 12 months

95060

Ophthalmic mucous membrane tests

48 in 12 months

95065

Direct nasal mucous membrane test

48 in 12 months

95070, 95071

Inhalation bronchial challenge testing

48 in 12 months

95076 (95079 is an add-on code that is not reported alone)

Ingestion challenge test

1 per year

NOTE: According to the guidelines of the American Academy of Allergy, Asthma, and Immunology (AAAAI), extracts (vaccines) with high proteolytic enzyme activities (e.g., fungi, dust mites, cockroach, and insect venoms) are separated from those without proteolytic enzyme activities. Therefore, patients will typically require only two (2) vials of allergen extracts. Any excess of three (3) multi-dose vials would be subject to review by the Medical Director.

The AAAAI practice guidelines make the following recommendations regarding immunotherapy frequency and duration:

• During the build-up phase, the usual frequency of vaccine administration is 1 – 2 injections per week, at least 2 days apart.

• Cluster immunotherapy is two or more injections administered per visit to achieve a maintenance dose more rapidly than with conventional schedules.

• Rush immunotherapy schedules can achieve maintenance dose more quickly than weekly schedules, but are associated with an increased risk of systemic reaction.

• When maintenance dose is achieved, intervals between injections can be progressively increased as tolerated to 4 – 6 weeks.

• Venom immunotherapy (VIT) injections generally are given at weekly intervals.

• VIT intervals between maintenance dose injections can increase to 4 weeks the first year of VIT and eventually to every 6 – 8 weeks during subsequent years.

• Clinical improvement is usually observed within one (1) year after the patient reaches maintenance dose.

• The decision to continue or stop therapy should be made after 3 – 5 years.

­ Consider discontinuing VIT after 3 – 5 years.

­ The duration of fire ant immunotherapy has not been clearly established, but most allergists recommend continuing therapy 4 – 5 years.

Reimbursement for allergy immunotherapy is based on the number of procedures performed and is subject to the limitations below:

Limitations:

CPT Code:

Procedure:

Limited to:

95115, 95117**

Administration of extract (allergen vaccine)

152 total injections within 12 months

95120, 95125

Allergenic extract (allergen vaccine) including administration

100 total doses within 12 months

95144

Allergenic extract, single dose vials (specify number of vials)

156 doses within 12 months (specify number of vials)

95165

Allergenic extract, single or multiple antigens (specific number of doses)

156 total doses within 12 months

95130 – 95134

Stinging insect venom, including administration

52 total doses within 12 months

95145 – 95149, 95170

Stinging insect venom

52 total doses within 12 months

OR

40 total doses within 3 months for rapid desensitization

95180

Rapid desensitization

4 hours for a specific substance

**Reimbursement for either a single injection (95115) or multiple injections (95117) is limited to one (1) per date of service, when provided by the same physician.

Allergy testing or immunotherapy services in excess of the above limitations are subject to medical review of documentation supporting medical necessity. The following information may be required documentation to support medical necessity: physician history and physical, care provider notes, and all laboratory studies.

LOINC Codes:

DOCUMENTATION TABLE

LOINC CODES

LOINC TIME FRAME MODIFIER CODE

LOINC TIME FRAME MODIFIER CODES NARRATIVE

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit note

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician initial assessment

18736-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Allergy tests

18716-1

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Laboratory studies (i.e., ELISA, RAST, PRIST, Mast)

26436-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage:

The following National Coverage Determinations (NCDs) were reviewed on the last guideline reviewed date and are located at cms.gov:

Antigens Prepared for Sublingual Administration (110.9)

Food Allergy Testing and Treatment (110.11)

Challenge Ingestion Food (110.12)

Cytotoxic Food Tests (110.13)

The following Local Coverage Determinations (LCDs) were reviewed on the last guideline reviewed date and are located at fcso.com:

Allergy Tests (L29057)

Allergen Immunotherapy (L29056)

DEFINITIONS:

ALCAT: antigen leukocyte cellular antibody) automated food allergy testing; is reported to identify food sensitivity by using a modified Coulter Counter linked to a computer program to measure the change in white blood cells incubated with purified food and mold extract.

Allergen: any substance that indicates a state of, or brings on, manifestations of allergy; an antigenic substance capable of producing immediate-type hypersensitivity.

Allergenic extract (allergen vaccine): an extract (allergen vaccine) of allergenic components from a crude preparation of an allergen (e.g., weed, grass, mite, animal dander) used for diagnostic skin testing or for immunotherapy (hyposensitization) of allergy.

Allergy: an over-reaction of the body’s immune system, against particular substances and particles (allergens, antigens) such as pollen, animal dander, dust, insect particles.

Antigen: the specific particle that one is allergic to, such as the specific part of pollen.

Antihistamine: drug that blocks the allergic reaction.

Asthma: a reversible obstructive lung disorder characterized by increased responsiveness of the airways; inflammation and irritation of the airways that may cause wheezing, sneezing, coughing, or shortness of breath.

Bronchial challenge: see provocation test; involves the inhalation of agents that trigger respiratory responses (i.e., drugs causing airway constriction, antigens and chemical sensitizers usually related to occupational breathing problems).

Conjunctival challenge: see provocation test; small amount of antigen is applied to the lower conjunctival sac.

Custer immunotherapy: an accelerated build-up schedule that entails administering several injections at increasing doses (generally 2 – 3 per visit) sequentially in a single day of treatment on nonconsecutive days. The maintenance dose is generally achieved more rapidly than with a conventional (single injection per visit) build-up scheduled (generally within 4 – 8 weeks).

Cytotoxic testing: for determining sensitivity to foods believed to cause asthma, arthritis, constipation, diarrhea hypertension, obesity, stomach disorders, and many other conditions; used in the 1980’s; controlled clinical studies have failed to demonstrate effectiveness or reliability.

ELISA (enzyme linked immunosorbent assay): an in vitro assay for allergen specific IgE antibodies in serum, indicating an allergy to the substance.

FAST (fluorescent allergosorbent test): an in vitro assay using a fluoregenic detection system that looks for allergen specific IgE antibodies in serum, indicating an allergy to the substance.

Food challenge test: used to confirm or diagnose IgE- mediated hypersensitivity to specific foods, food additives and preservatives (metabisulfite). Increasing amounts of the suspected food allergen is ingested every 15 – 20 minutes for 2 hours or until a reaction occurs or the amount is higher than that expected to produce a reaction. One food item is tested per day.

Idiopathic environmental intolerance: The original term, clinical ecology, was replaced by the term multiple chemical sensitivity (MCS). Most recently, it has been replaced by the term idiopathic environmental intolerance, a term reflecting the uncertain nature of the condition and its relationship to chemical exposure. The central focus of the condition is the fact that the patient describes recurrent, nonspecific symptoms referable to multiple organ systems that the sufferers believe are provoked by exposure to low levels of chemical, biologic, or physical agents. The most common environmental exposures include perfumes and scented products, pesticides, domestic and industrial solvents, new carpets, car exhaust, gasoline and diesel fumes, urban air pollution, cigarette smoke, plastics, and formaldehyde. Certain foods, food additives, drugs, electromagnetic fields, and mercury in dental fillings have also been reported as triggering events. However symptoms do not bear any relationship to established toxic effects of the specific chemical and occur at concentrations far below those expected to elicit toxicity.

Immunotherapy: allergy injection therapy; the process of injecting small amounts of substances causing the allergy reaction; over a period of time, doses are progressively increased until the body adjusts to the substance, or becomes desensitized; other treatments include avoidance of the substance or taking medications such as antihistamines to block the allergic reaction.

In vitro: within a glass or test tube; in an artificial environment.

In vivo allergy tests: used to identify allergic substances that are responsible for producing diseases such as asthma, allergic rhinitis, eczema, urticaria, anaphylaxis, and gastrointestinal reactions.

In vivo: within the living body.

Intradermal or Intracutaneous test: a small amount (.001 to .05 ml) of antigen extract (allergen vaccine) is injected into the skin with a disposable syringe attached to a 26- to 30- gauge needle or with a tuberculin type syringe; a reaction is recorded 15 – 30 minutes after application. This type of skin testing is more suitable to patients with lower skin sensitivity or for antigens with lower potency. Because of the added risk of adverse systemic reactions due to the larger volume of antigen extract (allergen vaccine) used, these tests are typically performed on the upper arm or forearm rather than the back, to allow application of a tourniquet if necessary, and are performed in a setting with staff capable of handling adverse reactions and emergencies.

IP (Immuno-peroxidase test): an in vitro assay for allergen specific IgE antibodies in serum, indicating an allergy to the substance.

LEAP: Lifestyle Eating and Performance disease management program (Don Self & Associates, Inc.) is based on the theory that symptoms of irritable bowel syndrome and other certain conditions are caused by reactions to specific foods and food additives. The program includes patient selection tools, a self-directed stress management program, and assessment tools for determining outcomes.

MAST (multiple thread allergosorbent test): an in vitro assay using an enzymatic detection system that looks for allergen specific IgE antibodies in serum, indicating an allergy to the substance.

Mediator release test (MRT): primarily used to detect intolerance to foods and additives in patients with irritable bowel syndrome. Also used in patients with chronic fatigue syndrome, metabolic conditions (e.g., diabetes, obesity), gastrointestinal disorders (e.g., gastroesophageal reflux disease, chronic ulcerative colitis, and Crohn’s disease), neurologic disorders (e.g., migraine headaches, cluster headaches), rheumatologic disorders (inflammatory arthritis, arthralgias, fibromyalgia), otolaryngologic disorders (e.g., perennial rhinitis, chronic sinusitis, chronic otitis media with effusion), dermatologic conditions (e.g., eczema, urticaria, dermatitis), and in patients with behavioral conditions (e.g., attention deficit disorder, hyperactivity, frequent mood swings, inability to concentrate). This test measures the aggregate release of inflammatory mediators from the patient’s immunocytes in vitro after exposure to specific foods and food additives. The results of the mediator release test have been used to design a patient-specific diet to treat irritable bowel syndrome by avoiding foods and additives that trigger significant inflammatory mediator release.

Nasal challenge: see provocation test.

Patch (application) test: antigen is impregnated into a small piece of gauze or filter paper disc and applied to a strip of aluminum foil or placed within an 8 mm diameter aluminum device (Finn chamber) and applied to the skin and held in place with tape (a test system known as the TRUE test uses multiple antigens incorporated into a gel delivery system); reactions are observed and recorded at 48 hours after application and may be read again 1 – 5 days after the first reading.

Prick or puncture test: a drop of antigen is placed directly on the skin then gently pricked through with a sharp instrument (needle, lancet, or specially designed plastic device) at a 45 – 60 degree angle (prick test) or 90 degree angle (puncture); reactions are recorded at 15 – 20 minutes after application.

PRIST (paper radioimmunosorbent test): an in vitro assay for allergen specific IgE antibodies in serum, indicating an allergy to the substance.

Proteolytic enzyme: when preparing mixtures of allergen extracts, the prescribing physician must take into account the cross-reactivity of allergen extracts and the potential for allergen degradation caused by proteolytic enzymes (breakdown of proteins).

Provocation test: challenge test performed to duplicate the patient’s main symptoms or signs by controlled exposure to a suspected antigen; can be delivered by ingestion (food, oral challenge), inhalation (bronchial challenge), or by direct application to the mucosal membrane of nares (nasal challenge) or conjunctiva (conjunctival challenge).

RAST (radio-allergo-sorbent test): an in vitro assay for allergen specific IgE antibodies in serum; designed to aid in the diagnosis of IgE-mediated disorders and in the formulation of allergen immunotherapy.

Rhinitis: inflammation of the nasal mucosa.

Rush immunotherapy: an accelerated immunotherapy build-up schedule that involves administering incremental doses of allergen at intervals varying between 15 and 60 minutes over 1 – 3 days until the targeted therapeutic dose is achieved. A rush immunotherapy schedules for inhalant allergens can be associated with a greater risk of systemic reactions, particularly in high-risk patients (e.g., those with markedly positive prick/puncture test responses), and premedication with antihistamines and corticosteroids appears to reduce the risk associated with rush immunotherapy.

SAGE: a cellular assay that tests for delayed food sensitivity; the SAGE method uses whole blood, rather than serum, and tests simultaneously for multiple pathways.

Scratch tests: the skin is superficially scratched with a blunt scarifying device in such a way as to prevent excessive bleeding; a drop of antigen extract (allergen vaccine) is then applied to the scratch; antigen and control sites are recorded 20 minutes after application.

Skin test: applying a small amount of an antigen extract (allergen vaccine) directly to the skin either by intradermal tests or by epicutaneous, epidural, or percutaneous tests (scratch, prick, puncture, and patch tests).

RELATED GUIDELINES:

None applicable.

OTHER:

Other terms describing allergy immunotherapy or allergy testing:

Allergy desensitization

Allergy shots

Hyposensitization

Specific antigen immunotherapy (SIT)

Other terms describing cytotoxic testing:

Cell Mediated Food Sensitivity

Food Intolerance Test (FIT)

Leukocyte-Antigen Sensitivity Testing (LAST)

Leukocytotoxic

Metabolic Intolerance Test (MIT)

Neutrophile Degranulation

Polymophonuclear Degranulation

White Cell Degranulation

REFERENCES:

  1. Abramson MJ, Puy RM, Weiner JM. Allergen immunotherapy for asthma. Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD001186. DOI: 10.1002/14651858.CD001186.
  2. Allergy Diagnostic Testing: An Updated Practice Parameter. I L Bernstein, JT Li, et al. Ann of Allergy Asthma Immunology; March 2008; Vol 100, No. 3, Supplement 3 (updated 05/22/09).
  3. American Academy of Allergy, Asthma and Immunology (AAAAI) and American College of Allergy, Asthma and Immunology (ACAAI), Joint Council of Allergy, Asthma and Immunology. Cox L, Nelson H, Lockey R, Calabria C, Chacko T, Finegold I, Nelson M, Weber R, Bernstein DI, Blessing-Moore J, Khan DA, Lang DM, Nicklas RA, Oppenheimer J, Portnoy JM, Randolph C, Schuller DE, Spector SL, Tilles S, Wallace D. Allergen immunotherapy: a practice parameter third update. J Allergy Clin Immunol 2011 Jan;127(1 Suppl):S1-55.
  4. American Academy of Allergy, Asthma and Immunology, American College of Allergy, Asthma and Immunology, Joint Council of Allergy, Asthma and Immunology. Food allergy: A practice parameter update 2014.
  5. American Academy of Allergy, Asthma and Immunology (AAAAI) and American College of Allergy, Asthma and Immunology (ACAAI) Task Force. Sublingual immunotherapy: A comprehensive review (05/06)
  6. American Academy of Allergy, Asthma and Immunology Position Statement: The Use of Standardized Allergen Extracts, (05/97).
  7. American Academy of Allergy, Asthma and Immunology Workgroup Report: Current Approach to the Diagnosis and Management of Adverse Reactions to Foods, (10/03).
  8. American Academy of Allergy, Asthma and Immunology. Physician Reference Materials: Position Statement 2, Some Untested Diagnostic and Therapeutic Procedures in Clinical Allergy.
  9. American Academy of Allergy, Asthma and Immunology. Physician Reference Materials: Position Statement 10, Skin Testing and Radio Allergosorbent Testing (RAST) for Diagnosis of Specific Allergens Responsible for IgE-Mediated Diseases.
  10. American Academy of Allergy, Asthma and Immunology. Physician Reference Materials: Position Statement 21, The Use of In Vitro Tests for IgE Antibody in the Specific Diagnosis of IgE-Mediated Disorders and in the Formulation of Allergen Immunotherapy.
  11. American Academy of Allergy, Asthma and Immunology. Physician Reference Materials: Position Statement 24, Allergen Skin Testing From the Board of Directors.
  12. American Academy of Allergy, Asthma and Immunology. Physician Reference Materials: Position Statement 35. Idiopathic environmental intolerance. J Allergy Clin Immunol. 1999; 103: 36-40.
  13. American Academy of Allergy, Asthma, and Immunology Position Statement 8. Controversial Techniques. J Allergy Clin Immunol. 1981; 67:333-338.
  14. American Academy of Allergy, Asthma & Immunology Position Statement – AAAAI support of the EAACI Position Paper on IgG4. Adverse Reactions to Foods Committee (05/2010).
  15. American Academy of Asthma, Allergy and Immunotherapy (AAAAI). Consultation and referral guidelines citing the evidence: How the allergist-immunologist can help. J Allergy Clin Immunol 2006;117:S495-523.
  16. American Medical Association CPT Coding (current edition).
  17. Barrett MD, Stephen. Allergies: Dubious Diagnosis and Treatment, (06/14/03; revised 01/17/08).
  18. Bernstein IL, Li JT, Bernstein DI, Hamilton R, Spector SL, Tan R, Sicherer S, Golden DB, Khan DA, Nicklas RA, Portnoy JM, Blessing-Moore J, Cox L, Lang DM, Oppenheimer J, Randolph CC, Schuller DE, Tilles SA, Wallace DV, Levetin E, Weber R, American Academy of Allergy, Asthma and Immunology, American College of Allergy, Asthma and Immunology. Allergy diagnostic testing: an updated practice parameter. Part 1. Ann Allergy Asthma Immunol. 2008 Mar;100(3 Suppl 3):S15-S66.
  19. Blue Cross Blue Shield Association 2003 TEC Assessment; “Sublingual Immunotherapy for Allergies”.
  20. Blue Cross Blue Shield Association Medical Policy 2.01.01 – Diagnosis and Management of Idiopathic Environmental Intolerance (i.e., Clinical Ecology), (05/09/13).
  21. Blue Cross Blue Shield Association Medical Policy 2.01.17 – Sublingual Immunotherapy as a Technique of Allergen Specific Therapy, (05/09/13).
  22. Blue Cross Blue Shield Association Medical Policy 2.01.23 – Serial Endpoint Testing for the Diagnosis and Treatment of Allergic Disorders, (06/13/13, archived).
  23. Burks AW, Calderon MA, Casale T et al. Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus report. J Allergy Clin Immunol 2013.
  24. Calderon MA, Alves B, Jacobson M, Hurwitz B, Sheikh A, Durham S. Allergen injection immunotherapy for seasonal allergic rhinitis. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD001936. DOI: 10.1002/14651858.CD001936.pub2.
  25. Canonica GW, Cox L, Pawankar R et al. Sublingual immunotherapy: World Allergy Organization position paper 2013 update. The World Allergy Organization journal 2014; 7(1):6.
  26. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination for Antigens Prepared for Sublingual Administration (110.9) (11/17/96).
  27. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination for Food Allergy Testing and Treatment, Publication 100-3, Section 110.11, (10/31/88).
  28. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination for Challenge Ingestion Food, Publication 100-3, Section 110.12, (08/01/78).
  29. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination for Cytotoxic Food Tests, Publication 100-3, Section 110.13, (08/05/85).
  30. Centers for Medicare and Medicaid Services (CMS). Medicare Benefit Policy Manual, Chapter 15 – Covered Medical and Other Health Services, Section 50.4.4.1 Payment of Antigens (02/29/08).
  31. Centers for Medicare and Medicaid Services (CMS). Medicare Claims Processing Manual, Chapter 12 – Physicians/Nonphysician Practitioners, Section 200, B3-15050 (issued 03/11/05).
  32. CPT™ Assistant Archives 1990 – 1999 (copyright 2000 AMA); June 97:10, Summer 91:15.
  33. ECRI Trends. Waste in healthcare from the specialist’s chair. (04/01/2012).
  34. First Coast Service Options (FCSO) Local Coverage Determination LCD# L29057 Allergy Tests, (effective 01/01/13).
  35. First Coast Service Options (FCSO) Local Coverage Determination LCD# L29056 Allergen Immunotherapy, (effective 10/01/11).
  36. First Coast Service Options (FCSO) Local Coverage Determination LCD# 95115 Coding Guidelines for allergen immunotherapy (09/03/10).
  37. First Coast Service Options (FCSO) Local Coverage Determination LCD# L31271 Coding Guidelines for allergy testing (01/01/13).
  38. Fornadley MD, John. Allergy Management for the Otolaryngologist. Otolaryngologic Clinics of North America, 31:111-127, 02/98.
  39. Gerez IF, Shek LP, Chng HH, Lee BW. Diagnostic tests for food allergy. Singapore Med J. 2010 Jan;51(1):4-9.
  40. HAYES Medical Technology Directory; Allergy Testing, In Vitro, RAST, and Other Immunoassays ALLE0403.06 (04/23/98; updated 03/24/03; updated and renamed 8/04 “Allergy Testing for Diagnosis of Allergic Rhinitis, In Vitro, Quantitative”). (08/08/03; updated 10/23/07).
  41. HAYES Medical Technology Directory; Allergy Testing, In Vivo, (08/22/06; updated 09/08/07).
  42. HAYES Search and Summary. Sublingual Immunotherapy Drops for Allergy Treatment (04/27/07).
  43. Joint Council of Allergy, Asthma and Immunology (JCAAI) Practice Parameter. Stinging insect hypersensitivity: A Practice Parameter Update (10/04).
  44. Joint Council of Allergy, Asthma and Immunology (JCAAI). Physician’s Instruction Guide for the Preparation of Allergen Extract (02/20/09)
  45. Joint Council of Allergy, Asthma and Immunology (JCAAI). Practice Parameters for Allergy Diagnostic Testing. Accessed 08/04/09.
  46. Moffitt, JE, Golden, DB, et al. Stinging insect hypersensitivity: a practice parameter update. J Allergy Clin Immunol 2004 Oct; 114(4):869-86.
  47. National Guideline Clearinghouse. Institute for Clinical Systems Improvement (ICSI) Diagnosis and management of asthma, (01/08).
  48. National Guideline Clearinghouse. Joint Task Force on Practice Parameters, American College of Allergy, Asthma and Immunology, American College of Allergy, Asthma and Immunology, Joint Council of Allergy, Asthma and Immunology. Allergen immunotherapy: a practice parameter second update, (09/07).
  49. National Guideline Clearinghouse. Moffitt JE, et al. Stinging insect hypersensitivity: a practice parameter update. J Allergy Clin Immunol 2004 Oct; 114(4):869-86.
  50. National Guideline Clearinghouse; American College of Allergy, Asthma, & Immunology. Food allergy: a practice parameter. Ann Allergy Asthma Immunol 2006 Mar;96(3 Suppl 2):S1-68. This is the current release of the guideline (accessed 09/23/14).
  51. National Guideline Clearinghouse. Consultation and referral guidelines citing the evidence: how the allergist-immunologist can help. (06/18/06; accessed 09/23/14).
  52. St. Anthony’s Complete Guide to Medicare Coverage Issues: 50-2, 50-22, 50-53, (03/01).
  53. St. Anthony’s ICD-9-CM Coding Book (current edition).
  54. Stapel SO, Asero R, Ballmer-Weber BK, Knol EF, Strobel S, Veiths S, Kleine-Tebbe J. Position Paper: Testing for IgG4 against food is not recommended as a diagnostic tool: EAACI Task Force Report. Allergy 2008:63:793-796.
  55. U.S. Department of Health and Human Services, US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER). Guidance for Industry; Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts. Nov. 2000.
  56. U.S. Department of Health and Human Services, US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER). Guidance for Industry; On the Content and Format of Chemistry Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test. April 1999.
  57. U.S. Food and Drug Administration (FDA); Vaccines, Blood, and Biologics. Standardized Allergenic Extracts. Accessed 08/04/09.
  58. U.S. Food and Drug Administration (FDA) Approval, Oralair (04/2014).
  59. U.S. Food and Drug Administration (FDA) Approval, Grastek (04/2014).
  60. U.S. Food and Drug Administration (FDA) Approval, Ragwitek (04/2014).
  61. Wilson DR, Torres Lima M, Durham SR. Sublingual immunotherapy for allergic rhinitis. Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD002893. DOI: 10.1002/14651858.CD002893.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/24/14.

GUIDELINE UPDATE INFORMATION:

05/15/01

Medical Coverage Guideline Reformatted and Revised.

01/01/02

HCPCS coding changes.

01/01/03

HCPCS coding changes.

05/15/03

Reviewed; limitation changed for allergenic extract.

05/15/04

Scheduled review; added “mediator release test” to list of non-covered services; formatting revisions.

05/15/05

Scheduled review; no change in coverage statement.

10/15/05

Revision consisting of adding information regarding SAGE food allergy test.

05/15/06

Scheduled review: added investigational statement for sublingual immunotherapy for allergies and added additional tests and immunotherapies for idiopathic environmental illness; updated references.

09/15/06

Revision consisting of adding 83516, 83518, 83519, 83520, and 86005 to the list of allergy tests.

01/01/07

Annual HCPCS coding update (deleted 95078.)

05/15/07

Scheduled review; reformatted guideline; no change in coverage statement.

01/01/08

Annual HCPCS coding update: descriptor revisions for codes 95004, 95024, and 95027.

07/15/08

Scheduled review; no change in position statement; updated references.

01/01/09

Annual HCPCS coding update: revised descriptors for 95010 and 95015.

01/09/09

Revisions consisting of addition of criteria regarding IgG food allergy testing; reference added.

11/15/09

Scheduled review; no position statement changes; medical society information added regarding mixing of allergen extracts; reimbursement limitations revised; definitions added; references updated.

01/01/10

Annual HCPCS coding update: revised descriptors for 83516, 83518, 83519, and 83520.

04/15/10

Revision to Billing/Coding and Reimbursement sections regarding 83516, 83518, and 83519.

12/15/10

Scheduled review; Position Statement unchanged; added information regarding LEAP program; coding section revised; related ICD-10 codes added; references updated; formatting changes.

04/15/11

Revision to Reimbursement section of the guideline regarding allergen extracts.

07/15/11

Revision; formatting changes.

10/01/11

Revision to Reimbursement section.

12/15/11

Revisions to Billing/Coding and Reimbursement sections.

03/15/12

Revision; Reimbursement section updated.

11/15/12

Annual review; position statement reformatted, references updated, formatting changes.

01/01/13

Annual HCPCS coding update: added 95017, 95018, 95076, and 95079; revised descriptors for 95004, 95027, 95120, 95125, 95130, 95131, 95132, 95133, and 95134; deleted 95010, 95015, and 95075.

11/15/13

Annual review; position statements unchanged; Program Exceptions section updated; references updated.

11/15/14

Annual review; position statement regarding sublingual immunotherapy revised; references updated; formatting changes.

06/15/16

Added CPT code 86001.

Date Printed: June 25, 2016: 01:35 PM