Limitations:
The following tests are considered not medically reasonable and necessary:
• Ingestion (Oral) Challenge Food Testing performed by the patient in the home, and not in the office setting, will not be covered.
• Provocative Testing for which there is limited or no evidence of validity include the cytotoxic test, the provocation-neutralization procedure, electrodermal diagnosis, applied kinesiology, the “reaginic” pulse test, and chemical analysis of body tissues. Controlled studies for the cytotoxic and provocation-neutralization tests demonstrated that the results are not reproducible and do not correlate with clinical evidence of allergy.
Electrodermal diagnosis and applied kinesiology have not been evaluated for efficacy. Similarly, the “reaginic” pulse test and chemical analysis of body tissues for various exogenous chemicals have not been substantiated as valid tests for allergy. Provocative and neutralization testing and neutralization therapy (Rinkel test) of food allergies (sublingual, intracutaneous and subcutaneous) are excluded from Medicare coverage because available evidence does not show these tests and therapies are effective.
• IgG and IgG Subclass Antibody Tests measure allergen-specific IgG and IgG subclasses by using immunoabsorption assays and IgG and IgG subclass antibody tests for food allergy/ delayed food allergic symptoms or intolerance to specific foods. These tests are considered experimental and investigational since there is insufficient evidence in the published peerreviewed scientific literature to support the diagnostic value of these tests.
• Antigens for which no clinical efficacy is documented in peer reviewed literature include the following: newsprint, tobacco smoke and leaf, dandelion, orris root, phenol, alcohol, sugar, yeast, grain mill dust, soybean dust (except when the patient has a known exposure to soybean dust such as a food processing plant), honeysuckle, marigold, goldenrod, fiberglass, wool, green tea, or chalk.
• Radioallergosorbent test (RAST), fluoroallergosorbent test (FAST), and multiple antigen simultaneous test (MAST) are in vitro techniques for determining whether a patient’s serum contains IgE antibodies against specific allergens of clinical importance. As with any allergy testing, the need for such tests is based on the findings during a complete history and physical examination of the patient. These tests are not appropriate in most general allergy testing. Instead, individual IgE tests should be performed against a specific antigen.
• ELISA (enzyme-linked immunoaorbent assay) test is another in vitro method of allergy testing for specific IgE antibodies against allergens. It is used to determine in vitro reaction to various foods and relies on lymphocyte blastogenesis in response to certain food antigens.
• Quantitative multi-allergen screen is a non-specific screen that does not identify a specific antigen. It is does not have sufficient literature demonstrating clear cut clinical implication. It is a screening tool and therefore not covered by Medicare.
• Effective August 5, 1985, cytotoxic leukocyte tests for food allergies are excluded from Medicare coverage because available evidence does not show that these tests are safe and effective. (CMS Pub. 100-03 Medicare National Coverage Determination (NCD) Manual, Chapter 1- Coverage Determinations, Part 2 Section 110.13-Cytotoxic Food Tests).
• Effective October 31, 1988, sublingual intracutaneous and subcutaneous provocative and neutralization testing and neutralization therapy for food allergies are excluded from Medicare coverage because available evidence does not show that these tests and therapies are effective. (CMS Pub 100-03 Medicare National Coverage Determinations Manual, Chapter
1- Coverage Determinations, Part 2, Section 110.11 – Food Allergy Testing and Treatment).
• The following tests are considered experimental and investigational for allergy testing as these have not been proven to be effective or appropriate for the evaluation and/ or management of IgE-mediated allergic reactions. This list is not all inclusive:
• Antigen leukocyte cellular antibody (ALCAT) automated food allergy testing
• Applied kinesiology or Nambudripad’s allergy elimination test (NAET (i.e., muscle strength testing or measurement after allergen ingestion)
• Anti-Fc epsilon receptor antibodies testing
• Anti-IgE receptor antibody testing
• Blood, urine, or stool micro-nutrient assessments
• Candidiasis test
• Chemical analysis of body tissues (e.g., hair)
• Chlorinated pesticides (serum)
• Chronic urticarial index testing
• Clifford materials reactivity testing
• Complement (total or components)
• Complement antigen testing
• C-reactive protein
•Cytokine and cytokine receptor assay
• Cytotoxic testing for environmental or clinical ecological allergy testing (Bryans Test, ACT)
• Electrodermal testing or electro-acupuncture
•Electromagnetic sensitivity syndrome/disorder (allergy to electricity, electrosensitivity, electrohypersensitivity, and hypersensitivity to electricity).
• Environmental cultures and chemicals
• Eosinophil cationic protein (ECP) test
• Food immune complex assay (FICA) or food allergenic extract immunotherapy
• General immune system assessments
• Immune complex assay
• Immunoglobulin G (IgG) testing for allergy
• Iridology
• Leukocyte antibodies testing
• Leukocyte histamine release test (LHRT)/basophil histamine release test
• Lymphocytes (B or T subsets)
• Lymphocyte function assay
• Mediator release test (MRT) or the LEAP program
• Metabolic assessments
• Multiple chemical sensitivity syndrome (a.k.a., idiopathic environmental intolerance (IEI), clinical ecological illness, clinical ecology, environmental illness, chemical AIDS, environmental/chemical hypersensitivity disease, total allergy syndrome, cerebral allergy, 20th century disease)
• Prausnitz-Kustner or P-K testing - passive cutaneous transfer test
• Pulse response test
• Qualification of nutritional assessments
• Rebuck skin window test
• Secretory IgA (salvia)
• Sage Complement Antigen Test
• Specific Immunoglobulin (IgG) (e.g., by Radioallergosorbent (RAST) or Enzyme-linked immunosorbent assay (ELISA)
• Sublingual provocative neutralization testing and treatment with hormones.
• Total serum IgG, immunoglobulin A (IgA) and immunoglobulin M (IgM)
• Venom blocking antibodies
• Volatile chemical panels (blood testing for chemicals)
• Live Cell Analysis
• Passive Transfer
• Cytotoxic Food Testing
Routine allergy re-testing does not meet the definition of medically necessity according to the practice parameters and recommendations from the American College of Allergy, Asthma, and Immunology (ACAAI), the American Academy of Allergy, Asthma, and Immunology (AAAAI), and the Joint Council of Allergy, Asthma, and Immunology (JCAAI).
Utilization Guidelines
It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.
It would not be expected that all patients would receive the same tests or the same number of sensitivity tests. The number of tests performed must be judicious and related to the history, physical findings and clinical judgment specific to each individual patient. The selection of antigens should be individualized, based on the history and physical examination.
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, but persistent symptoms suggestive of allergic disease where skin tests may be repeated one year later. Claims for retesting within a three-year period should be submitted with documentation of the medical necessity.
Testing done on separate days for different antigens is acceptable as long as the total number of tests done within any three-year period is not excessive.
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. If in vitro testing is inconclusive, and contraindications for skin testing have been resolved, then skin testing may be done and is covered.
The medical record must document this rationale. In vitro IgE testing will be limited to 30 allergens/beneficiary over a 12 month period. If more tests are performed, medical records may be requested.
A maximum of 55 allergy patch tests for diagnose of allergic contact dermatitis per beneficiary per year is allowed without the submission of documentation with the claim to support medical necessity. Greater than 55 patch tests per patient per year may result in a request of medical records.
It would not be expected that more than forty (40) units be reported for intracutaneous (intradermal) testing per year for a patient. If more than 40 units are reported, medical records may be requested.
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