Allergy Testing - 82785, 86001, 86003, 86005 Part 01

Coverage Indications, Limitations, and/or Medical Necessity

Overview:

Allergy testing is performed to determine a patient’s immunologic sensitivity or reaction to particular allergens for the purpose of identifying the cause of the allergic state. It is based on findings during a complete medical and immunologic history, and appropriate physical exam obtained by face-to-face contact with the patient.

Indications:

Allergy skin testing is a clinical procedure that is used to evaluate an immunologic response to allergenic material. It would not be expected that all patients would receive the same tests or the same number of sensitivity tests. The number and type of antigens used for testing must be chosen judiciously given the patient’s presentation, history, physical findings, and clinical judgment.

To be covered by Medicare, the antigens must meet all of the following criteria:

• Skin testing must be performed based on a complete history and physical exam,

• Proven efficacy as demonstrated through scientifically valid peer reviewed published medical studies, and

• Exist in the patient’s environment with a reasonable probability of exposure Allergy testing can be broadly subdivided into two methodologies:

• In vivo testing (skin tests): this testing correlates the performance and evaluation of selective cutaneous and mucous membrane tests with the patient’s history, physician examination, and other observations.

• Percutaneous Testing (scratch, puncture, prick) and is used to evaluate immunoglobulin E (IgE) mediated hypersensitivity. Percutaneous tests require medical supervision, since there is a small but significant risk of anaphylaxis. Overall, skin testing is quick, safe, and cost-effective. It remains the test of choice in most clinical situations where immediate hypersensitivity reactions are suspected.

Percutaneous testing is the usual preferred method for allergy testing. Medicare covers percutaneous (scratch, prick or puncture) testing when IgE-mediated reactions occur with any of the following:

a. Inhalants.

b. Foods. (Patients present with signs and symptoms such as urticarial, angioedema, or anaphylaxis after ingestion of specific foods. Testing for food allergies in patients who present with wheezing is occasionally required.)

c. Hymenoptera (stinging insects).

d. Specific drugs (penicillins, macromolecular agents, enzymes, and egg-containing vaccines). Skin testing is unreliable with other drugs.

• Intracutaneous/Intradermal Tests are usually performed when increased sensitivity is the main goal such as when percutaneous tests are negative and there is a strong suspicion of allergen sensitivity. Intradermal tests are injections of small amounts of antigen into the superficial layers of the skin. 

The test is interpreted after 48 hours, and typically once again at 72 or 96 hours, and the reactions are systematically scored and recorded. The patient is then informed and educated regarding specific allergies and avoidance of exposure. Avoidance of the identified allergen(s) is critical to patient improvement and resolution of the dermatitis.

Allergy patch testing is a covered procedure only when used to diagnose allergic contact dermatitis after the following exposures: dermatitis due to detergents, oils and greases, solvents, drugs and medicines in contact with skin, other chemical products, food in contact with skin, plants (except food), cosmetics, metals, rubber additives, other and unspecified. 

Patch tests may also be used and may be helpful when a distribution and persistence of dermatitis suggests a possible contact allergy, but the exact etiology of the dermatitis is unknown. 

These allergens are part of a useful, but limited series of 36 allergens. While this series of 36 allergens represents some of the most common contact allergies, there are a significant number of patients who suffer intractable contact dermatitis for which the 36 allergens are inadequate to diagnose their problem.

A supplemental series of allergens in this case can enhance accurate diagnosis, patient education, and treatment. This supplemental series is particularly critical in the diagnosis of occupationally induced dermatitis. 

If another supplemental series of allergens are clinical indicated for an accurate diagnosis, the documentation must support the medically reasonable and necessary use of the additional allergens.

• Photo Patch Testing uses two patches, with one of them being irradiated with ultraviolet light half way through the occlusive period. It is indicated to evaluate unique allergies resulting from light exposure. Some chemicals or medications produce an allergic reaction only when exposed to light (usually ultraviolet type A, UVA). Patients who are over-sensitive to light and those with a rash that appears on parts of the body normally exposed to light but that does not appear in areas shielded from the light should have a photo-patch test.

• Photo Tests is skin irradiation with a specific range of ultraviolet light. Photo tests are performed for the evaluation of photosensitivity disorders.

• Skin Endpoint Titration (SET) Testing or Intradermal Dilutional Testing (IDT) analyzes the highest dilution of a substance that produces a reaction, and may be used to determine the starting dose(s) of allergen immunotherapy.

• Delayed Hypersensitivity Skin Testing has been commonly used in three ways: anergy testing, testing for infection with intracellular pathogens, and testing for sensitivity to contact allergens. Accurate testing for contact allergy requires careful attention to technique, and limitation of testing to the specific allergens known to be associated with a contact reaction.

• Ophthalmic Mucous Membrane Tests and Direct Nasal Mucous Membrane Tests are rarely indicated. They are allowed when skin testing cannot test allergens. Ophthalmic mucous membrane tests and direct nasal mucous membrane tests are approved if levels of allergic mediators (such as histamine and tryptase) are measured and a placebo control is performed. 

This is usually performed in allergy research laboratories. It is also approved in the office setting if the physician is there to observe objective measurement of reactions which might include redness of the eyes, tearing and sneezing.

• Inhalation Bronchial Challenge Testing involves the inhalation of agents that can trigger respiratory responses and are often used to evaluate new allergens and/ or substantiate the role of allergens in patients with significant symptoms. Results of these tests are ordinarily evaluated by objective measures of pulmonary function and occasionally by characterization of bronchoalveolar lavage samples.

• Inhalation bronchial challenge tests should be performed as dose-response assays where in provocation concentration thresholds can be determined on the basis of allergen concentration required to cause a significant decrease in measured  pulmonary function.

• Inhalation bronchial challenge tests with occupational allergens need to be carefully controlled with respect to dose and duration of exposure. When industrial small molecular weight agents are assessed, tests should be performed under conditions of continuous monitoring of the specific chemical being assessed so as not to exceed the threshold limit level permitted in the workplace.

• Ingestion (Oral) Challenge Test involves the administration of sequentially or incrementally larger doses of the test item. The test items may include food or antibiotics.

The service is allowed once per patient encounter, regardless of the number of items tested, and includes evaluation of the patient’s response to the test items. Challenge ingestion food testing is a safe and effective technique in the diagnosis of food allergies. 

This procedure is covered when it is used on an outpatient basis if it is reasonable and necessary for the individual patient. (CMS Pub. 100-03 Medicare National Coverage Determination (NCD)Manual, Chapter 1- Coverage Determinations, Part 2 Section 110.12- Challenge Ingestion Food Testing).

Challenge ingestion food testing is covered for the following indications:

• Food allergy, dermatitis

• Anaphylactic shock due to adverse food reaction

• Allergy to medicinal agents

• Allergy to foods

Challenge ingestion food testing has not been proven to be effective in the diagnosis of rheumatoid arthritis, depression, or respiratory disorders. Accordingly, its use in the diagnosis of these conditions is not reasonable and necessary within the meaning of section 1862(a) (1) of the Medicare law, and no program payment is made for this procedure when it is so used. (CMS Pub. 100-03 Medicare National Coverage Determination (NCD)Manual, Chapter 1- Coverage Determinations, Part 2 Section 110.12- Challenge Ingestion Food Testing).

• Intracutaneous testing, delayed reaction - more than 6 tests, may be covered but requires additional justification and case-by-case review for the number of tests performed and the medical necessity except when the skin test is used: Prior to collagen implant therapy, a skin test for collagen sensitivity must be administered and evaluated over a 4 week period. CMS Pub 100-03 Medicare National Coverage Determinations (NCD) Manual, Chapter 1 – Coverage Determinations, Part 4, Section 230.10 – Incontinence Control Devices.

• Organ challenge test materials may be applied to the mucosae of the conjunctivae, nares, GI tract, or bronchi. Considerable experience with these methods is required for proper interpretation and analysis. All organ challenge tests should be preceded by a control test with diluent and, if possible, the procedure should be performed on a double blind or at least single-blind basis.

• In vitro testing (blood serum analysis): immediate hypersensitivity testing by measurement of allergen-specific serum IgE in the blood serum. They are useful when testing for inhalant allergens (pollens, molds, dust mites, animal danders), foods, insect stings, and other allergens such as drugs or latex, when direct skin testing is impossible due to extensive dermatitis, marked dermatographism, or in children younger than four years of age.

In vitro testing is covered when skin testing is not possible or would be unreliable; or in vitro testing is medically reasonable and necessary as determined by the physician. When in vitro testing is ordered or performed, the medical record must clearly document the indication and why it is being used instead of skin testing.

It is not covered when done in addition to a skin test for the same antigen, except in the case of suspected latex sensitivity, hymenoptera, or nut/peanut sensitivity where both the skin test and the in-vitro test may be performed. 

The number of tests done, choice of antigens,  frequency of repetition and other coverages issues are the same as skin testing. Testing must be based on a careful history/physical examination which suggests IgE medicated disease. Total Serum IgE is not appropriate in most general allergy testing. 

Instead, individual IgE tests are performed against a specific antigen. Special clinical situations in which specific IgE immunoassays are performed against a specific antigen may be appropriate in the following situations:

• Patients with extensive dermatitis, severe dermatographism, ichthyosis or generalized eczema that will not make direct skin testing possible.

• Patients needing continued use of H-1 blockers (antihistamines), or in the rare patient with persistent unexplained negative histamine control.

• Patients who cannot be safely withdrawn from medications that interfere with skin testing, such as long-acting antihistamines, tricyclic antidepressants, beta-blockers, or medications that may put the patient at undue risk if they are discontinued long enough to perform skin tests.

• Uncooperative patients with mental or physical impairments.

• For evaluation of cross-reactivity between insect venoms (e.g., fire ant, bee, wasp, yellow jacket, hornet).

• As adjunctive laboratory testing for disease activity of allergic bronchopulmonary aspergillosis and certain parasitic disease.

• To diagnose atopy in small children.

• Patients at increased risk for anaphylactic response from skin testing based on clinical history (e.g., when an unusual allergen is not available as a licensed skin test extract), or who have a history of a previous systemic reaction to skin testing.

• Patients in who skin testing were equivocal/inconclusive and in vitro testing is required as a confirmatory test.

Total IgE is reasonable and necessary for follow-up of ABPA and to diagnosis atopy in children.

Retesting with the same antigen(s) should rarely be necessary within a three-year period. Exceptions include young children with negative skin tests, or older children and adults with negative skin tests in the face of persistent symptoms. Routine repetition of skin tests is not indicated (i.e., annually) and not covered.

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