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Allergic or hypersensitivity disorders may be manifested by generalized systemic reactions as well as localized reactions in any organ system of the body. The reactions may be acute, subacute or chronic, immediate or delayed, and may be caused by numerous offending agents; e.g., pollen, molds, dust, mites, animal dander, stinging insect venoms, foods and drugs.
The optimum management of the allergic patient should include a careful history and physical examination and may include confirming the cause of allergic reaction by information from some of the testing methods outlined below. Once the agent is identified, treatment is provided by avoidance, medication or immunotherapy.
The following allergy tests are available in the diagnosis of the allergic patient:
1. Direct Skin Test
• Percutaneous (scratch, prick or puncture)
• Intracutaneous (intradermal)
2. Patch Test (Application Test)
This test modality identifies allergens causing contact dermatitis. The suspected allergens are applied to the patient's back under dressings and allowed to remain in contact with the skin for 48 hours. The area is then examined for evidence of delayed hypersensitivity reactions.
This test reflects contact photosensitization. A patch of skin is applied with the suspected sensitizer for 48 hours. If no reaction occurs, the area is exposed to a dose of ultraviolet light sufficient to produce inflammatory redness of the skin. If the test is positive, a more severe reaction develops at the patch site than on surrounding skin.
• Radioallergosorbent Tests (RAST)
These tests detect antigen-specific IgE antibodies in the patient's serum.
5. Total Serum IgE Concentration
This testing modality is not indicated in most allergic patients, but may be indicated for those patients suspected of having allergic bronchopulmonary aspergillosis, immune deficiency disease characterized by increased IgE levels; (e.g., Wiskott-Aldrich syndrome, hyper-IgE staphylococcal abscess syndrome), IgE myeloma or pemphigoid.
Histamine or methacholine is used to perform this test when it is necessary to determine if the patient has hyper-responsive airways. Volatile chemicals are used to perform the test when the allergy is encountered in an occupational setting.
With this test, the patient ingests the food to which sensitivity is suspected. Both the patient and the physician are "blinded." This is usually done at home, but in some instances of extreme suspected hypersensitivity, it may be performed in the office setting.
8. Serial Endpoint Testing (SET)
Serial endpoint testing (SET) is a form of intradermal skin testing that uses increasing doses of antigen to determine the concentration at which the reaction changes from negative to positive (the "endpoint"). The test has been used for diagnosing allergic disorders, and is a potential alternative to other diagnostic tests such as skin prick testing or in vitro testing for this purpose. Also SET has been used to guide the initiation of immunotherapy, by using the endpoint dilution as the starting antigen dose.
The following allergy tests are considered medically necessary in the diagnosis of the allergic patient:
1. Direct Skin Tests
The number of tests required may vary widely from patient to patient, depending upon the patient's history. There is a limit of 50 percutaneous and up to 20 intracutaneous skin tests per day.
A test is defined per antigen, not per injection of antigen (added 4/28/00).
3. Photo Patch Test
4. Specific IgE In Vitro Tests:
• Radioallergosorbent Tests (RAST)
• Multiple Radioallergosorbent Tests (MAST)
• Fluorescent Allergosorbent Test (FAST)
• Enzyme-linked Immunosorbent Assay (ELISA)
These tests detect antigen-specific IgE antibodies in the patient's serum. They are considered medically necessary only once when testing for: inhalant allergens, (pollens, molds, dust, mites, animal danders), foods, insect stings, and other allergens such as drugs, when direct skin testing is impossible due to extensive dermatitis or marked dermatographism. Also appropriate in children less than four years of age or if the patient's symptoms are life threatening (ie, suspected peanut allergy).
5. Total Serum IgE Concentration
6. Certain Bronchial Challenge Tests
7. Double Blind Food Challenge Test
This is usually done at home, but in some instances of extreme suspected hypersensitivity, it may be performed in the office setting. In the latter case, this is considered to be part of the office visit and no additional benefits are provided.
8. Serial Endpoint Testing (SET)
Serial endpoint testing (SET) may be considered medically necessary for the determination of a safe starting dose for testing or immunotherapy when there is potential for the specific allergen in question to produce a severe systemic allergic reaction or anaphylaxis (i.e., chemicals, drugs, bee venom or peanuts).
Repeat skin testing with multiple antigens is not medically necessary unless there is clear documentation of rare and extraordinary circumstances such as:
• Initially sensitive to food and indoor environmental exposures but later develop pollen and outdoor mold sensitivities.
• Dramatic change of symptoms
The following allergy tests are considered investigational, and not covered:
1. Provocative tests for food or food additive allergies
2. Nasal challenge test
3. Conjunctival challenge test (ophthalmic mucous membrane test)
4. Cytotoxic food tests
5. Rebuck skin window test
6. Passive transfer or P-X (Prausnitz-Küstner) test
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.
Examples of non-covered items considered to be used for environmental medicine/clinical ecology include but are not limited to:
• Barrier cloth cover for mattresses
POLICY EXCEPTIONSRepeat testing is not medically necessary unless there is clear documentation of rare and extraordinary circumstances as described in POLICY.
Hood Container Corp Union and Non-Union plans do not have a limit on allergy injections and testing.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY9/1992: Issued
2/1997: Revised: Limitation on number of tests; denial of repeat testing except in rare circumstances; moved two tests (nasal and conjunctival challenge) to Investigational list.
4/28/00 See clarification under POLICY.
5/23/2001: Code reference section updated; ICD-9 diagnosis codes 117.3, 496.7, and 708.3 deleted; non-covered codes table added
11/2001: Reviewed by MPAC; SDET or Rinkel Method changed to covered
2/11/2002: Investigational definition added
4/18/2002: Type of Service and Place of Service deleted
6/5/2002: Code Reference section updated
6/12/2002: ICD-9 diagnosis code 117.3, 692.73 and 708.3 added, CPT code 95078 moved to covered
11/3/2004: Code Reference section updated, CPT code 95078 description revised covered codes, ICD-9 diagnosis code range 477.0-477.9, 692.0-692.6, 692.72-692.74 listed separately covered codes, ICD-9 diagnosis 989.5 description revised covered codes, ICD-9 diagnosis code 692.84, E906.4, V15.01, V15.02, V15.03, V15.04, V15.05, V15.06, V15.07, V15.08, V15.09 added
09/12/2006: Coding Updated. ICD-9 2006 revisions added to policy
10/25/2006: Policy updated to include allergy testing limits are per day
12/21/2006: Code reference section updated per the 2007 CPT/HCPCS revisions
1/3/2007: Serial endpoint testing (SET) moved to investigational per BCBSA policy
1/4/2007: Code reference section updated; CPT 95027 moved to non-covered; describes SET
8/17/2007: Policy section partially re-written for clarity; no change in policy
8/22/2007: Code reference section reviewed. CPT 95015 moved to non-covered; describes SET
12/12/2007:Code reference section updated per the 2008 CPT/HCPCS revisions
12/24/2008: Code reference section updated per the 2009 CPT/HCPCS revisions
6/16/2009: Policy statement updated. Additional information regarding Serial Endpoint Testing (SET) added to the description section of the policy. Policy statement updated to include medically necessary indcations for Serial Endpoint Testing (SET). CPT code 95027 moved to covered table.
6/24/2009: CPT code 95015 moved to covered table
7/16/2009: Policy revisions approved by Medical Policy Advisory Committee (MPAC)
9/29/2009: Code reference section updated. Description revised for ICD-9 code V15.06. ICD-9 diagnosis code 995.2 deleted from covered table due to code was deleted as of 10-1-2006. CPT procedure code 95078 deleted from covered table due to code was deleted as of 12-31-2006.
03/22/2010: Code reference section updated. Code description revised for CPT code 82784.
07/08/2010: Policy description unchanged. Policy statement regarding serial endpoint testing revised to change the term "systemic reaction" to "systemic allergic reaction." Intent of policy statement unchanged.
08/20/2011: Deleted information regarding leukocyte histamine release test (LHRT) and removed 86343 from the Code Reference section.
07/12/2012: Added the following to the Policy Exceptions section: Hood Container Corp Union and Non-Union plans do not have a limit on allergy injections and testing.
12/21/2012: Added the following new 2013 CPT codes to the Code Reference section: 95017, 95018, 95076, and 95079.
08/26/2015: Medical policy revised to add ICD-10 codes. Removed deleted CPT codes 95010, 95015, and 95075 from the Code Reference section.
04/13/2016: Policy guidelines updated to add medically necessary and investigative definitions.
06/07/2016: Policy number added.
SOURCE(S)TEC Evaluations 1990: In Vitro Allergy Testing, p. 56
TEC Evaluations 1987: pp. 185 and 193
Blue Cross Blue Shield Association policy #2.01.23
Blue Cross Blue Shield Association policy #2.04.42
Hayes Medical Technology Directory
CODE REFERENCEThis 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.
This is not an all-inclusive list of non-covered procedure codes.
The code(s) listed below and ANY code not listed in the previous section are considered non-covered for this procedure.