ELIMINATING ERRORS ON ALLERGY TESTING & ALLERGY IMMUNOTHERAPY DOCUMENTATION

Coverage Indications, Limitations, and Documentation Requirements

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, and is based on findings during a complete medical and immunologic history and appropriate physical exam obtained by face-to-face contact with the patient.

Allergy testing can be broadly subdivided into two methodologies:

A.         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.

Testing Type	Description
Percutaneous testing (scratch, puncture, prick)	Intracutaneous (intradermal) testing are used to evaluate immunoglobulin E (IgE) mediated hypersensitivity to inhalants, foods, hymenoptera (e.g., bee venom), drugs and/or chemicals.
Patch testing	Is used to differentiate allergic contact dermatitis (ACD) and irritant contact dermatitis (ICD).
Photo patch	Is used to evaluate unique allergies resulting from light exposure.
Photo tests	Performed for the evaluation of photosensitivity disorders.

B.         In vitro testing (blood serum analysis): immediate hypersensitivity testing by measurement of allergen-specific serum IgE (CPT code 86003). Special clinical situations in which specific IgE immunoassays may be appropriate are included in the following table.

 ** In vitro allergy testing is not covered on the situations explained on the table below, because it is considered not medically reasonable and necessary.

Covered Situations	Non Covered Situations
Patients with severe dermatographism, ichthyosis or generalized eczema	Patients with no contraindications to skin testing
Patients who cannot be safely withdrawn from medications that interfere with skin testing (such as long-acting antihistamines, tricyclic antidepressants)	Patients being treated successfully for allergies
Uncooperative patients with mental or physical impairments.	Patients with mild symptoms
Evaluation of cross-reactivity between insect venoms (e.g., fire ant, bee, wasp, yellow jacket, hornet)	Patients who have had negative skin testing for the allergy in question In vitro testing is covered when medically reasonable and necessary as a substitute for skin testing; it is not usually necessary in addition to skin testing.
As adjunctive laboratory testing for disease activity of allergic bronchopulmonary aspergillosis and certain parasitic diseases.
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 whom skin testing was equivocal/inconclusive and in vitro testing is required as a confirmatory test.

C.         Other testing types

ü  Qualitative multi-allergen screen (CPT code 86005) is a non-specific screening test that does not identify a specific antigen, and is not covered by most health insurance providers.

ü  The use of sublingual, intracutaneous, and subcutaneous provocative and neutralization testing and neutralization therapy for food allergies are excluded from Medicare and most health insurance providers coverage, because available evidence does not show that these tests and therapies are effective.

ü  Allergen-specific IgG and IgG subclasses measured by using immunoabsorption assays and IgG and IgG subclass antibody tests for food allergy/delayed food allergic symptoms or intolerance to specific foods (eg., CPT code 86001) are considered experimental and investigational, as there is insufficient evidence in the published peer-reviewed scientific literature to support the diagnostic value of these tests.

ü  Measurements of total IgE levels (CPT code 82785-Gammaglobulin [immunoglobulin]; IgE) are not appropriate in most general allergy testing which 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 would not be expected that total serum IgE levels would be billed unless evidence exists for allergic bronchopulmonary Asperigillosis (ABPA), select immunodeficiencies, such as the syndrome of hyper-IgE, eczematous dermatitis, atopic dermatitis in children and recurrent pyogenic infections, or in the evaluation for omalizumab therapy.

Documentation Requirements

The allergy skin test form should provide enough information for other physicians and healthcare professionals to understand what tests were performed, how the tests were performed and to be able to interpret them.

Medical record documentation must include the following information, and be available upon request:

ü  A complete medical and immunologic history and appropriate physical exam obtained by face-to-face contact with the patient.

ü  The medical necessity for performing the test.

ü  The test methodology used.

ü  Location of the test (e.g. back, arm, etc…)

ü  Instrument used (e.g. testing device, needle size, commercial kit, etc…)

ü  Time elapsed between application of the test and reading of the test

ü  The measurement (in mm) of reaction sizes of both wheal and erythema response (in vivo testing).

ü  Concentration, dilution and diluent used in testing

ü  The medical necessity for the use of in vitro testing if used, instead of in vivo methods.

ü  The quantitative result (in kIU/L) for specific IgE testing (in vitro testing).

ü  The interpretation of the test results and how the results of the test will be used in the patient’s plan of care.

All diagnostic tests must be ordered by the physician/nonphysician practitioner who is treating the patient.

Allergen Immunotherapy

Allergen immunotherapy (desensitization), also referred to as specific immunotherapy, is the subcutaneous introduction of increasing doses of allergens to which the patient is sensitive. Allergen immunotherapy is antigen-specific; thus the sensitivity of the patient must be known before formulating extracts for therapy.

This therapy is generally reserved for patients with significant relapsing, subacute to chronic symptoms, where the symptoms are likely caused by allergic pathology, and in situations where other means of conservative therapy (including avoidance) have failed to control the symptoms adequately, or avoidance of the relevant allergen (e.g., dust mites, pollen, mold) is impractical.

Coverage
Coverage for allergen immunotherapy will be provided for patients with allergic rhinitis, allergic conjunctivitis, asthma, or a previous anaphylactic reaction to a stinging/biting insect or other arthropod when all four of the following criteria are met:

(1) The patient must have significant exposure to an allergen

(2) The patient must have demonstrated a significant level of sensitivity to the allergen

(3) The pattern of symptoms must conform to the pattern of exposure

(4) Other means of conservative therapy (including avoidance) have failed to control the symptoms, or avoidance of the relevant antigen (e.g., dust mites, pollen, mold) is impractical.

Generally, the course of allergen immunotherapy, if successful, should be continued until the patient has been symptom-free or has had substantially reduced symptoms for 1 to 2 years and in most cases from 3 to 5 years. If no response has occurred after 1 year at maintenance dose, the patient’s sensitivities should be reviewed. All patients on immunotherapy should be encouraged to maintain environmental control and may have to use concomitant medication, such as antihistamines.

Documentation Requirements

Medical record documentation maintained by the treating physician must clearly document the medical necessity to initiate allergen immunotherapy and the continued need thereof. The documentation should include:

ü    A history and physical that documents the following: a complete allergic history and physical examination; correlation of symptoms; occurrence of symptoms; exposure profile; documentation of allergic sensitization by accepted means and where attempts at avoidance have proven unsuccessful (or the impracticality of avoidance exists); and a copy of the sensitivity results.

Immunotherapy antigens mixing logs including the following information;

ü    Antigen mixed on each vial

ü    Dilution

ü    Volume

ü    Units

Immunotherapy Injections documentation with the following information;

ü    Date

ü    Dosage

ü    Injection site

ü    Reaction

ü    Healthcare provider signature (who administer the injection)

ELIMINATING DOCUMENTATION ERRORS IMPROVE CODING AND BILLING !

 Source: Medicare Claims Processing Manual, Chapter 12, Section 50(e) and Medicare Local and National coverage determination.