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Lab Management Guidelines V2.0.2021
In-vitro Allergy Testing
MOL.CS.317.X
v2.0.2021
Introduction
In-vitro testing for allergy is addressed by this guideline.
Procedures Addressed
The inclusion of any procedure code in this table does not imply that the code is under
management or requires prior authorization. Refer to the specific Health Plan's
procedure code list for management requirements.
Procedure addressed by this guideline Procedure code
Allergen specific IgG; quantitative or 86001
semiquantitative, each allergen
Allergen specific IgE; quantitative or 86003
semiquantitative, each allergen
Allergen specific IgE; qualitative, 86005
multiallergen screen (e.g. disk, sponge,
card)
Allergen specific IgE; quantitative or 86008
semiquantitative, recombinant or purified
component each
Immunoassay for analyte other than 83516
infectious agent antibody or infectious
agent antigen; qualitative or
semiquantitative, multiple step method
Gammaglobulin (immunoglobulin); IgE 82785
Peanut allg spec asmt 64 epi 0165U
Peanut allg asmt epi clin rx 0178U
What Is Allergy
Definition
Allergy is defined as an immunologically mediated, hypersensitive response to an
agent in a sensitized person.1-7
Mechanistically, there are several different pathways of hypersensitivity. In vitro allergy
testing is largely concerned with Type I immediate hypersensitivity reactions mediated
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by IgE.8 These reactions usually involve a response to an allergen in a previously
sensitized individual that can manifest anywhere from minutes to a few hours. Typical
clinical signs and symptoms have been described as follows: 8
“Common manifestations of type I hypersensitivity reactions include signs and
symptoms that can be:”
o “Cutaneous (eg, acute urticaria, angioedema)”
o “Respiratory (eg, acute bronchospasm, rhinoconjunctivitis)”
o “Cardiovascular (eg, tachycardia, hypotension)”
o “Gastrointestinal (eg, vomiting, diarrhea)”
o “Generalized (eg, anaphylactic shock)...”
Allergy and allergy testing, is commonly divided into 5 categories: 1
Allergic contact dermatitis (ACD)6
Stinging insect allergy caused by venoms7
Food allergy5
Inhalant allergy (aeroallergy)2,4
Drug allergy3
There is overlap between the categories and, in general, a patient with one type of
allergy is at increased risk of experiencing another. An example of the overlap between
categories is latex allergy, where the presentation can be cutaneous (mild contact
urticaria), respiratory (asthma, rhinoconjunctivitis) or generalized (anaphylactic shock). 9
Cross reactivity between different classes of allergens can result in unique clinical
syndromes such as the oral allergy syndrome (OAS), which involves cross-reaction
between food allergens and aeroallergens.10
Cross reaction between food allergens and pollen aeroallergens is known as the
pollen-food syndrome. It is “a localized IgE-mediated reaction… which causes
tingling and itching of the mouth and pharynx. This is typically triggered after
consumption of certain fresh fruits and vegetables in pollen-allergic individuals. It is
caused by cross reactivity between IgE antibodies to certain pollens with proteins in Allergy Testing
some fresh fruits and vegetables...”10
Latex-fruit syndrome is another OAS caused by cross-reaction between inhaled
latex antigens and some fresh fruits and vegetables. 11
Practice parameters published jointly by the American Academy of Allergy, Asthma and
Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology
(ACAAI) describe the diagnosis and management of the 5 types of allergy. 1-7 The
common themes in these practice parameters are:
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The history and physical are the foundation of diagnosing allergy. For
uncomplicated cases, if the history and physical are convincing enough, it is within
the standard of care for providers treat the allergy without additional testing.
The focus of the diagnostic workup is identifying the allergen responsible for the
allergic reaction.
Diagnostic testing is an adjunct to the history and physical and diagnostic testing
alone without clinical correlation is insufficient to make a diagnosis. This is because
sensitization to an allergen, which can produce a positive test, is not the same as
disease. In allergic disease, the patient is sensitized and experiences a
hypersensitivity reaction after allergen exposure.
Challenge testing is the gold standard of diagnosis. Thus, oral food challenges are
the gold standard of food allergy testing. Challenges are time consuming, with
potential serious side effects including anaphylaxis. Therefore, they must take place
in a medical setting with appropriate safeguards.
After identifying a causative allergen, the basis of treatment is avoidance of the
allergen, immune desensitization, or both.
There are two general classes of first-line, high-volume testing methods used in the
diagnosis of immediate hypersensitivity allergic disease. These are skin testing and in
vitro testing of blood.1,12
Skin tests are generally performed in the office. There are several types, each
useful in specific settings. In percutaneous skin testing (or skin prick testing, SPT),
a specific allergen is pricked onto the skin with a device, and in intradermal testing
the allergen is injected under the skin with a needle. Percutaneous testing is the
method of choice for food allergy.5,13,14 In a third type of skin testing, patch testing,
contact allergens are incorporated into a gel attached to a fabric backing to form a
patch that is applied to the skin. This method has been highly standardized and is
the test of choice to confirm ACD.6
In vitro testing of blood is most commonly performed by a clinical laboratory. The
two most common blood tests are allergen-specific serum IgE testing (sIgE) and
total IgE testing.1,8
The AAAAI/ACAAI practice parameters indicate that skin testing is recommended,
and in vitro testing is not for ACD and drug allergy testing. 3,6 For stinging insect
allergy, inhalant allergy, and food allergy, skin testing is preferred over in vitro
Allergy Testing
testing of blood, but both can be useful.2,5,7 In general, when either skin testing or
blood testing is useful, physicians tend to prefer skin testing. 12 Blood testing tends
to be preferred when there are factors preventing accurate testing of skin, for
example as occurs in patients with widespread eczema.
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Test Information
Introduction
In vitro tests for allergy include immunoglobulin and non-immunoglobulin tests.
Total IgE
This test is performed by automated immunoassay by one of several FDA-approved
methods. The test is an adjunct to allergen specific IgE in selected clinical settings
such as in patients with severe eczema.14 There is controversy regarding the clinical
utility of this test, which has led to admonitions against routine use. 5
Allergen Specific IgE (sIgE)
A summary of the fundamentals of in vitro testing of blood for allergen specific IgE has
been published by Siles and Hsieh.8 This test is most commonly performed by
automated immunoassay, and measures patient serum IgE binding to an extract of a
specific allergen (e.g. peanut, sesame seed, honeybee venom, birch pollen), usually by
fluorescence-labeled assay. In vitro testing for allergen specific IgE is indicated to help
confirm a diagnosis of food allergy, inhalational allergy, allergy from stinging insect
venoms, or latex. Depending on the antigen being tested, in vitro testing of blood for
allergen specific IgE varies in sensitivity from 60 – 95% and in specificity from 30%-
95%.1,8,15,16
Although allergen specific IgE is usually performed by automated immunoassay, it is
less commonly performed by an older multi-allergen dipstick method suitable for
doctor’s offices.17,18 The dipstick method tests for a preset panel of multiple allergens
even if testing some of the allergens is not supported by the patient history and
physical.
Another version of allergen specific IgE testing is component testing, also referred to
as component-resolved diagnostics (CRD).5,19,20 Kattan and Wang describe the method
as follows:
“Instead of using crude allergen extracts consisting of a mixture of allergenic and
non-allergenic components, CRD uses pure allergen proteins, produced by
purification from natural allergen sources or recombinant expression of allergen- Allergy Testing
encoding complementary DNA.” 19
CRD is performed by automated methods based on either a fluorescence enzyme
immunoassay or a microarray.
Food Allergen Epitope Analysis
A method that attempts to further refine allergen specific IgE testing using as antigens
a panel of synthetic peptides, usually 15 to 20 amino acids in length, selected from a
library of overlapping peptides that tile the entire sequence of the allergenic protein(s)
of interest. IgE binding to each individual peptide is measured to create a “map” of
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epitopes.21,22 The test is usually performed using a microarray chip or bead-based
multiplex assay. It is considered a promising area of investigation but is still
investigational and not currently recommended for use in the diagnosis and
management of allergy.13,14
Allergen Specific IgG
This test is performed by automated or manual immunoassay. It is often misused in the
workup of food intolerance and occasionally used for allergies to stinging insect
venoms.1,8 It is not recommended for routine use in the diagnosis and management of
allergy or food intolerance.1,23,24
Antigen Leukocyte Antibody Test (ALCAT)
This is a proprietary, laboratory-developed test for food sensitivity performed by Cell
Science Systems Incorporated.25 It is an assay for cytotoxicity performed by flow
cytometric immunoassay. It is not recommended for use in the diagnosis and
management of allergy.1,23,26
Guidelines and Evidence
Introduction
Guidelines concerning allergy testing are based on the American Academy of Allergy,
Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and
Immunology (ACAAI) practice parameters and on general literature review. 27 They are
grouped below according to test-based recommendations.
Total IgE, Gammaglobulin (immunoglobulin) Testing (CPT 82785)
Measuring total IgE levels is occasionally considered medically necessary to interpret
the significance of specific IgE-related allergy diagnoses. There are a variety of modest
uses. For example, the allergy testing practice parameter states:
“The clinical applications of total serum IgE are of modest value. High serum IgE
concentrations occur in allergic bronchopulmonary Aspergillosis (ABPA), the
therapeutic response of which is evaluated by serial IgE values.” 1
Allergy Testing
The utility of total IgE in food allergy is also modest and the test should not be done
haphazardly. Thus, the AAAAI/ACAII guideline on food allergy states:
5
“Do not routinely obtain total serum IgE levels for the diagnosis of food allergy.”
One application in food allergy is that high total serum IgE levels in the context of food
allergy diagnosis support asymptomatic sensitization, and indicate decreased
likelihood that a positive allergen specific test is a true positive. Thus, the EEACI
guideline for food allergy states:
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“Determination of total IgE is particularly useful in patients with severe eczema; a
very high total IgE level suggests that positive sIgE results should be interpreted
with care as they may represent asymptomatic sensitization.” 14
Another use of Total IgE is assessing which patients with allergic asthma or chronic
spontaneous urticaria would benefit from therapy with omalizumab. The allergy testing
practice parameter states:
“Total serum IgE is required for assessing the suitability of a patient for omalizumab
therapy and determining the initial dose.” 1
Allergen Specific IgE (sIgE) (CPT 86003)
The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American
College of Allergy, Asthma and Immunology (ACAAI), have created joint practice
parameters for all 5 categories of allergy.27 Recommendations for in vitro testing for
allergen specific IgE (CPT 86003) for each of the five types of allergy are considered
below.
Allergic contact dermatitis (ACD)
Although over 3000 contact allergens have been identified, just 65 specific
allergens account for >90% of ACD diagnoses in the United States.1 The AAAAI /
ACAAI practice parameter for ACD states that patch testing is the gold standard. In
vitro blood tests are not recommended, even for the few allergens related to ACD
where they are available.6 The Joint AAAAI/ ACAAI practice parameter states:
o “In patients suspected of ACD, patch testing is the gold standard to confirm the
diagnosis.” 6
The recommendation is similar in pediatrics:
o “Patch testing should be performed and remains the gold standard for the
diagnosis of ACD in children.” 6
Regarding in vitro testing of blood in ACD:
o “Although in vitro tests for delayed hypersensitivity to contact allergens (i.e.,
metals and bone cement) are available, routine use of such assays is not
currently recommended as their sensitivity and specificity for diagnosing ACD Allergy Testing
has not been determined and should be considered investigational.” 6
Latex IgE-mediated allergy
Latex allergy has a broad spectrum of signs and symptoms, ranging from mild
contact urticaria to asthma or anaphylactic shock. Diagnostic algorithms for latex
allergy are similar to the other categories of allergies, where clinical and laboratory
testing is indicated only in the setting of appropriate clinical history. 28
Testing can be performed by either skin prick or specific serum IgE. Each of these
is subject to difficulties due to the variation in antigenicity of natural rubber latex,
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and sensitivity and specificity vary by the specific extract used. For example,
“studies indicate that the antigenic specificities of proteins in the extracts of the
finished products differ from those proteins extracted from the raw material.” 29
Further complicating the diagnosis of latex allergy, there are no FDA-approved latex
skin test reagents.30 Existing commercially available latex extracts “show
considerable heterogeneity in their protein and major allergen composition, and this
may negatively affect the accuracy of SPT testing.”28
Despite the lack of an FDA-approved skin prick test latex allergen, skin prick test
may be the preferred initial diagnostic test. The AAAAI/ACAAI practice parameter
summarizes the recommended evaluation for suspected work-related natural
rubber latex allergy:1
o “...a positive skin prick test result with a NRL [natural rubber latex] extract (if
available) is preferred to demonstration of elevated specific IgE with an FDA-
cleared assay due to higher sensitivity of the former. Current IgE-mediated
allergy and asthma caused by
NRL allergens is highly unlikely in the presence of a
negative skin prick test result with a reliable crude NRL allergen extract.
Elevated in vitro specific IgE levels can be used to confirm NRL allergy, but a
negative result does not exclude NRL allergen sensitization.”
Latex sIgE assays also vary in their performance. The commonly available
ImmunoCAP and Immulite sIgE assays have a diagnostic sensitivity and sensitivity
of 70% and >95%, respectively, compared to skin prick testing. Because of the
relatively low sensitivity, “care should be exercised when interpreting negative IgE
antibody results from the CAP and AlaSTAT assays, even at their manufacturers'
recommended positive cutoffs, since these assays misclassify approximately 25%
of subjects who are skin test positive as IgE antibody negative (false negative).” 31
Stinging insect venoms
For allergies to stinging insect venoms, the AAAA /ACAAI practice parameter
summarizes the nature of the disease and recommendations regarding diagnosis
and treatment.7 The foundation of diagnosis is the history and physical combined
with information regarding the geographic distribution of the suspected insect as
well as its biology and behavior. Therapy is focused on avoidance, access to
emergency medication to treat anaphylaxis, and desensitization with venom Allergy Testing
immunotherapy (VIT).
The practice parameter indicates that testing, either by skin prick testing, serum
allergen specific IgE, or both, is useful only for patients who have had a systemic
reaction to an insect sting, and who are candidates for VIT. Testing is not indicated
for patients who have had a local reaction only.7 Thus, the practice parameter
makes the following three statements: 7
o “Recommend to patients who have a history of systemic reactions to insect
stings… referral for evaluation by an allergist/immunologist, the utility of specific
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IgE testing for stinging insect sensitivity, and the potential advantages of VIT
(testing is not necessary for patients in whom VIT is not required).”
o “Perform skin tests and/or serum tests for IgE to stinging insect venoms on
patients who are candidates for VIT.”
o “Recommend and initiate VIT in all patients who have experienced an
anaphylactic reaction to an insect sting and who have specific IgE to venom
allergens.”
The practice parameter warns against therapy based only on test results without an
appropriate history of systemic disease: “Avoid VIT based solely on in vivo and in vitro
testing for venom IgE, without a history of systemic reaction to a sting.” 7
If the insect is not known, then the panel that is recommended consists of 5 tests as
follows with a preference for skin testing over in vitro testing of blood for allergen
specific IgE:7
o “Use skin tests as the preferred test for initial demonstration of venom-specific
IgE. In vitro measurement of serum IgE should be used as a complementary or
alternative test. Test for all 5 venoms, with the possible exception of individual
patients in whom a single culprit is definitively known.”
The five venoms are as follows: “Extracts of honeybee, yellow jacket, white-faced
hornet, yellow hornet, and wasp venom are available for skin testing and VIT.” 7
In addition, in special circumstances suggested by the history and physical, a sixth
test for fire ant venom is sometimes indicated: “However, fire ant venom is only
included under special circumstances.” 7
Food allergy
For food allergy, the AAAAI and ACAAI have developed a joint practice parameter. 5
In addition, evidence-based analysis and guidelines have been published by the
United States National Institute of Health and the European Academy of Allergy and
Clinical Immunology (EAACI).10,14,15 Lastly, the joint AAAI/ACAAI practice parameter
on allergy testing has a significant section dedicated to food allergy testing. 1 The
various guidelines and practice parameters are consistent regarding the need to be
guided by the clinical history and physical, the distinction between allergic
sensitization and allergic disease, the importance of limiting the testing based on
Allergy Testing
patient-specific clinical information, and the limitations of testing regarding both
false positives and false negative results.
The NIH guideline clearly states that sensitization is not the same as disease, and
therefore exposure-related signs and symptoms must be present to diagnose food
allergy:13
o “Because individuals can develop allergic sensitization (as evidenced by the
presence of allergen-specific IgE (sIgE)) to food allergens without having clinical
symptoms on exposure to those foods, an sIgE-mediated [food allergy] requires
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both the presence of sensitization and the development of specific signs and
symptoms on exposure to that food.”
The AAAAI/ACAAI practice parameter on testing summarizes the overall diagnostic
approach to food allergy, then states the limitations of testing from the perspective
of both sensitivity and specificity, and how these limitations lead to restrictions on
the usefulness of panels if they are not supported by clinical information: 1
o “The primary tools available to evaluate patients’ adverse reactions to foods
include history (including diet records), physical examination, prick/puncture skin
tests, serum tests for food specific IgE antibodies, trial elimination diets, and oral
food challenges.”
o “A detailed dietary history, at times augmented with written diet records, is
necessary to determine the likelihood that food is causing the disorder, identify
the specific food, and determine the potential immunopathophysiology.”
o “With regard to evaluations for IgE antibody–associated food allergies, tests for
food specific IgE antibody include percutaneous skin tests (prick/puncture tests)
and serum assays. In general, these tests are highly sensitive (generally 85%)
but only modestly specific (approximately 40% to 80%) and therefore are well
suited for use when suspicion of a particular food or foods is high. They are not
effective for indiscriminate screening (eg, using panels of tests without
consideration of likely causes) and therefore generally should not be used for
that purpose.”
Similar conclusions are drawn by the AAAAI/ACAAI food allergy practice parameter
and the EAACI food allergies guidelines:5,14
o “The clinician should obtain a detailed medical history and physical examination
to aid in the diagnosis of food allergy.” 5
o “The clinician should use specific IgE tests (skin prick tests, serum tests, or
both) to foods as diagnostic tools; however, testing should be focused on foods
suspected of provoking the reaction, and test results alone should not be
considered diagnostic of food allergy.” 5
14
o “Detailed clinical history is essential for the diagnosis of food allergy.”
o “Where available, standardized tests and procedures should be used ...specific Allergy Testing
allergy testing should be directed by case history.” 14
o “Either SPT or sIgE can be the test of choice for sensitization depending on
local availability and absolute and relative contraindications to SPT.” 14
The recommended or maximum size of an initial food allergy workup is not stated
numerically in any of the food allergy or general allergy testing guidelines
mentioned above. The AAAAI/ACAAI practice parameter suggests limiting the
workup to the small number of allergens that cause the majority of food allergy: 5
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o “Although more than 170 foods have been identified as triggers of food allergy,
those causing most of the significant allergic reactions include peanut, tree nuts,
fish, shellfish, milk, egg, wheat, soy, and seeds.”
o “Evaluate the patient for possible food allergy with the understanding that a
relatively small number of allergens cause a high proportion of food allergy (eg,
cow’s milk, hen’s egg, soy, wheat, peanut, tree nuts, fish, and shellfish).”
Overall, food allergy prevalence is approximately 5-10% in the United States, with
allergy more common in children than adults and 95% of food allergies caused by
one or more of 9 common foods listed above. 5,13,16,32 The short list of common food
allergens has led the Canadian government to create a modified list of 11 “priority
allergens” which have food labeling requirements. 33 The 11 allergens consist of the
nine allergens from the AAAAI/ACAAI practice parameter (peanut, tree nuts, fish,
shellfish, milk, egg, wheat, soy, and seeds); sulfites; and seeds are divided into two
types, sesame and mustard.5
The rationale for not extending beyond this list, except in special cases guided by
the clinical history, is the high frequency of over-diagnosis of food allergy because
of sensitization in the absence of clinical correlation. 5,16 This leads to a high number
of false positive results.
The over-diagnosis problem is best understood by using a predictive value
calculator which incorporates prior probability of disease and test sensitivity and
specificity to calculate the likelihood of a test being a true positive. 34 The prior
probability, which is also known as pretest probability of disease, is based on
patient specific information from the history and physical as well as epidemiologic
information about the likelihood of disease. Thus, a patient with significant allergic
signs and symptoms after exposure to a particular food would have a high pretest
probability of allergy to that food, and a patient with no signs or symptoms of allergy
after exposure would have a near-zero pretest probability.
Positive predictive value (PPV) is the likelihood that a positive test is a true positive,
thereby indicating the presence of disease. PPV is highly dependent on the pretest
probability and the specificity of the test, and dependent to a much lesser extent on
test sensitivity. The below shows examples of PPV for a positive allergen-specific
IgE test, starting from a range of pretest probabilities, assuming an average
specificity of 60% and sensitivity of 85%, figures in line with those for many sIgE
assays.1,15,16
Allergy Testing
o Pretest probability 1% - PPV 2%
o Pretest probability 2% - PPV 4%
o Pretest probability 5% - PPV 10%
o Pretest probability 10% - PPV 19%
Beyond the 11 most common food allergens, the pretest probability of a food allergy in
the absence of a strong clinical history is miniscule; most allergens have a pretest
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probability of disease of far less than 5%. Even for a relatively high pretest probability
of 5%, the likelihood that a positive sIgE test indicates true allergy is only 10%, while
the chance that it represents a false positive is 90%. This is why large panel testing, in
the absence of suggestive clinical history, leads to overdiagnosis. A recent review of
food allergy testing highlights the problem of high false positive rates caused by large
allergen panels and failure to consider prior probability in interpreting test results: 16
o “The greatest source of misdiagnosis in food allergy might well be the lack of
appreciation that a positive test result (sensitization) does not equate with
allergy and that indiscriminate ‘‘panel testing’’ can result in a disaster of
misdiagnosis. In a national sampling of pediatricians and family practice
physicians, fewer than 30% of the participants felt comfortable interpreting
laboratory tests to diagnose food allergy.”
The joint AAAAI/ACAAI practice parameter on allergy testing also advocates for
considering prior probability before testing and in test interpretation : 1
o “The rational selection, application, and interpretation of tests for food specific
IgE antibodies require consideration of the epidemiology and underlying
immunopathophysiology of the disorder under investigation, estimation of prior
probability that a disorder or reaction is attributable to particular foods, and an
understanding of the test utility and limitations.”
Inhalation allergy
For inhalational allergy, the AAAI and ACAAI have developed joint practice
parameters that cover allergic rhinitis, allergic rhinosinusitis, and inhalational allergy
testing.1,2,4 The practice parameters point out the same general principles discussed
for the other forms of allergy apply to inhalational allergy. The main principle is that
allergic sensitization is not the same as allergic disease and leads to false positive
results and over diagnosis in patients who are sensitized but who are not clinically
hypersensitive when challenged with the allergen. Thus, testing needs to be guided
and limited by the clinical history and physical, as well as the geographic,
environmental and seasonal characteristics of the aeroallergen. Overly large panels
in the setting of low pretest probability of disease lead to poor positive predictive
values and false diagnosis.
It is difficult to determine a specific upper limit on the number of inhalational
allergens to test. The AAAAI/ACAAI practice parameter on testing summarizes the Allergy Testing
problem:1
o “If inhalation allergy is narrowly confined to a single season (eg, ragweed in
North America or birch in European northern countries), a limited number of
relevant skin tests would suffice for confirmation of the clinical diagnosis and
testing to irrelevant inhalant and food allergens would be inappropriate. By
contrast, perennial symptoms would require a more extended skin test panel of
both indigenous outdoor and indoor inhalants but not foods unless a history of
food allergy happened to be a concurrent problem of the patient. There is
general agreement that significant indoor allergens such as house dust mite,
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prevailing indoor fungal allergens (Penicillium species, Aspergillus species,
Alternaria alternata), cockroach, and epidermals (cat, dog, feathers), should be
tested in patients with perennial respiratory symptoms. Pollens may also be
found indoors when windows are kept open. The geographic variability of
airborne-pollinating plants throughout the floristic zones of the world, particularly
in North America, raises a cogent concern about how to select the number of
skin tests and treatment reagents for this class of allergens.”
o While this statement refers to skin testing, it can be extrapolated to in vitro
testing of allergen specific IgE.
The American Academy of Otolaryngic Allergy gave a specific recommendation
regarding the size of an inhalational screening panel and the size of the
confirmatory panel if the screening panel is positive. 35 The guideline states:
o “Screen with no more than 14 relevant antigens plus appropriate controls. If
screening is positive and immunotherapy is contemplated, use no more than 40
antigens.” 35
Regarding the constituents of the panel, the guideline states:
o “The screening battery must represent relevant classes of antigens, both
seasonal and perennial, to which patients are commonly exposed. Pollens from
each of the three major seasonal allergens (ie, grasses, weeds, and trees) are
used to represent seasonal antigens. Pollens included in the panel should be
representative of common antigenic substances in the relevant geographic
region. Perennial antigens include mold, dust mite, animal dander, and (in
certain circumstances) cockroach.” 35
Drug allergy
For drug allergy, the AAAAI/ ACAAI practice parameter includes an algorithm for
diagnosis and management.3 The foundation of diagnosis in drug allergy is the
history and physical looking for signs and symptoms of allergy that are in temporal
relation to the administration of a drug. Laboratory testing is an adjunct to diagnosis
and testing is often not available. The parameter states:
o “Diagnosis of many cases of drug allergy is presumptive because specific
confirmatory tests are usually not available.” 3 Allergy Testing
IgE mediated drug allergy is caused by a large number of drugs, most commonly
penicillin. For IgE-mediated drug allergy, skin testing – either skin prick or
intradermal - is preferred to in vitro testing of blood. The parameter states:
o “The most useful test for detecting IgE-mediated drug reactions caused by
penicillin and many large-molecular-weight biologicals is immediate
hypersensitivity skin testing.” 3
In addition, the lack of usefulness of in-vitro testing for IgE-mediated drug allergy is
noted:
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o “In situations where skin test results cannot be interpreted properly (ie,
generalized eczema, dermatographism, or lack of response to the positive
histamine control) some in vitro assays for specific IgE are available. However,
they are not as sensitive as skin tests and generally do not have optimal
negative predictive value.” 3
This is emphasized specifically for penicillin allergy testing:
o “The usefulness of in vitro tests for penicillin specific IgE is limited by their
uncertain predictive value. They are not suitable substitutes for penicillin skin
testing.” 3
Allergen Specific IgE, Qualitative, Multiallergen Screen (CPT 86005)
The AAAAI/ACAAI practice parameter on testing does not mention the dipstick based
multi-allergen methods.1 The use of an unchangeable list of pre-selected allergens is
contrary to the approach recommended by the AAAAI/ACAAI practice parameters
which focus on using the history and physical to select specific tests. 1-7 Furthermore,
the multi-allergen methods are more expensive than automated methods coded with
CPT 86003. The combination of these factors indicates that allergen-specific IgE using
CPT 86005 can be considered obsolete.
Allergen Specific IgE, Recombinant or Purified Component (CPT 86008)
Allergen component diagnostics has been suggested as a method for improving
allergen-specific IgE testing in food allergy; this topic has been reviewed by Kattan and
Wang.19 The authors state:
“There is clearly room for improvement in testing to differentiate asymptomatic
sensitization from true clinical allergy prior to OFC [oral food challenge]. Allergen
component-resolved diagnostics (CRD) have garnered a lot of attention in recent
years in the diagnosis of food allergy, offering the possibility of a more accurate
assessment while requiring less patient serum.” 19
Current AAAAI/ACAAI food allergy practice parameters recommend component testing
in two specific situations. For diagnosing red meat allergy, the parameters recommend
testing against a specific single component, galactose-alpha-1,3-galactose:
“Test for IgE antibodies specific for the immunogenic oligosaccharide galactose-
Allergy Testing
alpha-1, 3-galactose (alpha-gal) in patients who report a delayed systemic reaction
to red meat or unexplained anaphylaxis, particularly if they have a history of
previous tick bites.” 5
Practice parameters published in 2014 indicated 5 peanut components (Ara h 1, 2, 3,
8, and 9) that showed promise in offering greater precision in the diagnosis and
management of peanut allergy.5 An update in late 2020 recommends testing a single
component, Ara h 2:5,36
“If a single diagnostic test were to be used, testing for the Ara h 2 component would
provide the most diagnostic accuracy, as determined by the more optimal
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positive/negative likelihood ratio among the presently available testing options.
However, this is contingent on Ara h 2 component testing becoming more
commonly available as a stand-alone test, as opposed to being primarily offered by
laboratories as a panel with other peanut components.” 36
“However, while Ara h 2 has the greatest specificity, it has lower sensitivity than
[skin prick test] and sIgE [against whole peanut extract], and in a patient with a high
prior probability, the clinician may use Ara h 2, SPT, or sIgE to confirm the diagnosis
of peanut allergy.”36
Of note, the practice parameters specifically suggest against routinely combining
whole peanut and Ara h 2 component testing, or skin prick test and Ara h 2
component testing, arguing that diagnostic accuracy is not increased by performing
multiple tests
Regarding other peanut components, the authors observe there is still a paucity of
data about the clinical significance of sensitization to other components, particularly
Ara h 8, which, in the absence of sensitization to other peanut components, is
associated with decreased likelihood of true allergy. They state, “Further research is
needed to clarify the value of tandem testing, particularly with regard to Ara h 2, Ara
h 6, and Ara h 8.”36
A separate expert review of the literature concluded that there is insufficient evidence
for component testing in other food allergies: 19
“For the diagnosis of food allergy, CRD offers the potential to identify patients with
clinical allergy as opposed to patients who are merely sensitized but tolerant. CRD
has been extensively studied for use in the diagnosis of peanut allergy, and there
are well-known associations between particular peanut allergen components, risk of
clinical allergy, and the possibility of tolerance. For other food allergens, the clinical
relevance is not well established…CRD is not yet ready to replace current
diagnostic tests, and oral food challenge remains the gold standard in the diagnosis
of food allergy.”
Food Allergen Epitope Analysis (0165U, 0178U)
Food allergen epitope analysis such as VeriMAP™ proposes to refine allergy testing
further. Most background studies utilize a microarray chip rather than a bead-based
assay. In a study of 24 peanut sensitized children, this method found that sera from Allergy Testing
sensitized children bound a greater diversity of epitopes than controls. 21 A subsequent
study of 62 patients confirmed this finding. 37 A bead-based microarray study of 160
patients (73 with peanut allergy) showed differences in binding to a number of
epitopes.22 In small studies, epitope repertoire and sIgE levels appear to change in
response to oral immunotherapy, and differences in epitope repertoire may be useful in
predicting sustained response to immunotherapy in patients with milk allergy. 22,26,38
It is not yet clear whether food allergen epitope analysis is clinically valid, either for
diagnosis of peanut allergy, prediction of response to therapy, or monitoring therapy. A
few small clinical studies evaluate food allergen epitope analysis in the diagnosis of
peanut allergy, one on the VeriMAP platform. 21,22,37 No published studies assess the
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value of food allergy epitope testing in predicting response to therapy in peanut allergy.
Only one small clinical study or 22 patients, using microarray, reported changes in food
allergen epitope repertoire following oral immunotherapy for peanut allergy. 38
There is no data to support clinical utility for food allergen epitope analysis. No
published studies compare it to established methods of food allergy testing.
Allergen Specific IgG (CPT 86001)
The allergen specific IgG test is available widely on the clinical market despite lacking
the evidence base required to support clinical validity and utility.
The current joint AAAAI / ACAAI practice parameters state that allergen-specific IgG
testing is not useful in the diagnosis of food allergy. Summary statements regarding
this testing:5
“Unproved tests, including allergen specific IgG measurement, cytotoxicity assays,
applied kinesiology, provocation neutralization, and hair analysis, should not be
used for the evaluation of food allergy.”
“Measurement of food-specific IgG and IgG4 antibodies in serum are not
recommended for the diagnosis of non–IgE-mediated food-related allergic
disorders.”
“IgG and IgG subclass antibody tests for food allergy do not have clinical relevance,
are not validated, lack sufficient quality control, and should not be performed.”
The NIH expert panel (EP) guidelines for food allergy (FA) make the same
recommendation:13
"The EP recommends not using any of the following nonstandardized tests for the
routine evaluation of IgE-mediated FA:
o Basophil histamine release/activation...
o Allergen-specific IgG4
o Cytotoxicity assays"
The Choosing Wisely Campaign and AAAAI state:
“Don't perform unproven diagnostic tests, such as immunoglobulin G (lgG) testing
Allergy Testing
or an indiscriminate battery of immunoglobulin E (lgE) tests, in the evaluation of
allergy.” 24
One proposed use of allergen specific IgG testing is in the monitoring of venom
immunotherapy (VIT) in the context of stinging insect allergy. Once again, the joint
practice parameter indicates this is an unproven use:
“Although a number of investigators have reported modest increases of IgG4
during venom immunotherapy, confirmation and validation of the predictive value of
IgG4 for therapeutic efficacy of venom immunotherapy are not yet proven.” 1
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“Measurements of venom-specific IgG antibodies have no predictive value when
discontinuing VIT.” 7
Antigen Leukocyte Antibody Test (ALCAT®; CPT 83516)
The antigen leukocyte antibody test (ALCAT®), is a proprietary test from Cell Science
Systems Inc that tests for food sensitivity but not food allergy according to the
company. The test is based on cellular toxicity related to white blood cell activity. This is
often known as a “cytotoxic test”. In describing the ALCAT, the company’s website
states:
“The laboratory analysis includes the immune biological reactions of the white blood
cells. The Alcat Test® does not measure food allergies (type 1/IgE). Since these
reactions can be serious, you should seek the help of an allergy specialist if you
suspect or have food allergies.” 25
The joint AAAAI/ACAAI practice parameter on allergy testing states that cytotoxic
testing is not diagnostically valid:
“Procedures for which there is no evidence of diagnostic validity include cytotoxic
tests, provocation-neutralization, electrodermal testing, applied kinesiology,
iridology, hair analysis, or food specific IgG, IgG4, and IgG/IgG4 antibody tests.” 1
Similarly, the joint AAAAI/ACAAI food allergy practice parameter recommends against
cytotoxicity assays:
“Unproved tests, including allergen specific IgG measurement, cytotoxicity assays,
applied kinesiology, provocation neutralization, and hair analysis, should not be
used for the evaluation of food allergy.” 5
The NIH expert panel (EP) guidelines for food allergy (FA) make the same
recommendation:13
"The EP recommends not using any of the following nonstandardized tests for the
routine evaluation of IgE-mediated FA:
o Basophil histamine release/activation
o Lymphocyte stimulation
Allergy Testing
o Facial thermography
o Gastric juice analysis
o Endoscopic allergen provocation
o Hair analysis
o Applied kinesiology
o Provocation neutralization
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o Allergen-specific IgG4
o Cytotoxicity assays"
Similarly, the Australasian Society of Clinical Immunology and Allergy (ASCIA) lists the
ALCAT as an unorthodox, inaccurate, unproven allergy test along with a similar
cytotoxic test called “Bryan’s Test”.23 The ASCIA position statement says:
“Cytotoxic testing (“Bryan’s test”) and the Alcat test (Evidence Level II: inaccurate
test). In cytotoxic food testing (“Bryan’s test”), the size and shape of white cells is
assessed after incubation with food extracts on a microscope slide. These results
have been shown to not be reproducible, give different results when duplicate
samples are analysed blindly, don’t correlate with those from conventional testing,
and “diagnose” food hypersensitivity in subjects with conditions where food allergy
is not considered to play a pathogenic role. The Alcat test is a variant on a theme;
the results are analysed on a Coulter counter instead of under the microscope.” 23
Criteria
Introduction
This guideline addresses in-vitro testing of blood for allergic disease. It does not
address either skin testing or oral tolerance testing for allergic disease.
Total IgE, Gammaglobulin (immunoglobulin) Testing
Total IgE, Gammaglobulin (immunoglobulin) testing (CPT 82785)
Medical necessity requirements
Total IgE is indicated in the following circumstances:
o History and/or physical exam suggestive of allergic disease including any of the
following signs or symptoms :
Cutaneous findings such as angioedema or urticaria, or
Respiratory findings such as rhinitis, conjunctivitis, or bronchospasm, or Allergy Testing
Cardiovascular findings such as tachycardia or hypotension , or
Gastrointestinal findings such as vomiting or diarrhea , or
Signs or symptoms of anaphylaxis
Billing and reimbursement
When testing is medically necessary, the following limitations apply:
o No more than 1 unit of CPT 82785 may be billed for the same date of service.
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Allergen Specific IgE, Quantitative or Semiquantitiative
Allergen specific IgE (CPT 86003)
Medical necessity requirements
Allergen specific IgE is indicated in the following circumstances:
o History and/or physical exam suggestive of allergic disease including any of the
following signs or symptoms:
Cutaneous findings such as angioedema or urticaria, or
Respiratory findings such as rhinitis, conjunctivitis, or bronchospasm, or
Cardiovascular findings such as tachycardia or hypotension, or
Gastrointestinal findings such as vomiting or diarrhea, or
Signs or symptoms of anaphylaxis
o Testing for allergic contact dermatitis or drug allergy is not indicated.
o Population-based screening for allergic disease is not considered medically
necessary.
Billing and reimbursement
Because allergy testing is not indicated without signs or symptoms of allergic
disease, claims should be submitted with an ICD code adequately describing
coverable signs and symptoms to be paid. Claims for CPT 86003 will not be
payable when billed without any coverable ICD code defined in this policy.
Exceptions may be made for uncommon presentations on a case-by-case basis.
When allergen specific IgE testing is medically necessary, the following limitations
apply to the number of allowable billed units (allergens tested). In the uncommon
event that additional units are necessary, exceptions will be considered on a case-
by-case basis.
o When CPT 86003 is billed with an ICD code from table ICD Codes Indicating
Stinging Insect Venom Allergy Testing, up to 6 units will be coverable for the
same date of service.
Allergy Testing
o When CPT 86003 is billed with an ICD code from table ICD Codes Indicating
Food Allergy Testing, up to 11 units for the same date of service.
o When CPT 86003 is billed with an ICD code from table ICD Codes Indicating
Inhalational Allergy Testing or ICD Codes Indicating Latex Allergy Testing, up to
14 units are coverable for the same date of service. Exceptions may be
considered in some situations when follow-up testing for a positive screening
test that requires a larger panel of allergens is being performed.
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Because allergen specific IgE testing is not indicated for allergic contact dermatitis
or drug allergy, the following limitations apply:
o When CPT 86003 is billed with an ICD code from table ICD Codes Indicating
Drug Allergy Testing, no units will be payable given this is not a coverable
indication. Exceptions may be considered in the rare event that skin testing
cannot be performed for drug allergy testing.
o When CPT 86003 is billed with an ICD code from table ICD Codes Indicating
Acute Contact Dermatitis Testing, no units will be payable given this is not a
coverable indication. Exceptions may be considered in the rare event that skin
testing cannot be performed for allergic contact dermatitis testing.
Claims submitted without an ICD code indicating specific allergy symptoms as
defined in the ICD Codes section of this policy will not be considered medically
necessary and will not be eligible for reimbursement.
Given that no common indications support coverage of more than 14 units of CPT
86003, exceptions for uncommon indications that require more than 14 units of
allergen specific IgE testing will be considered on a case-by-case basis.
Allergen Specific IgE, Qualitative, Multiallergen Screen
Allergen specific IgE (CPT 86005)
Medical necessity requirements
The multi-allergen dipstick and related testing coded with CPT 86005 is considered
obsolete and is not eligible for reimbursement for any clinical indications.
Allergen Specific IgE , Quantitative or Semiquantitative, Recombinant or Purified
Component
Allergen specific IgE, component testing (CPT 86008)
Medical necessity requirements
Component testing is indicated in the diagnosis of patients suspected of having
peanut allergy. Allergy Testing
Component testing is indicated in the diagnosis of patients suspected of having red
meat allergy.
Component testing is not indicated in the evaluation of any other allergens.
Billing and reimbursement
When allergen specific IgE component testing is medically necessary, the following
limitations apply:
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o When CPT 86008 is billed with an ICD code from table ICD Codes Indicating
Nut Allergy Testing, up to 5 units are coverable for the same date of service.
o When CPT 86008 is billed with an ICD code from table ICD Codes Indicating
Red Meat Allergy Testing, one unit is coverable for the same date of service.
Claims for CPT 86008 billed without a coverable ICD code, in accordance with
these guidelines, will not be reimbursable. Exceptions may be made for uncommon
presentations on a case-by-case basis.
Food Allergen Epitope Analysis
Food allergen epitope analysis (0165U, 0178U)
Medical necessity requirements
Food allergen epitope analysis is considered investigational and experimental and
is not eligible for reimbursement for any clinical indications.
Allergen Specific IgG
Allergen specific IgG (CPT 86001)
Medical necessity requirement
Medical necessity of allergen specific IgG has not been demonstrated, and is
therefore determined to be investigational and experimental. This procedure code is
not eligible for reimbursement for any clinical indications.
Immunoassays for Allergy Testing, Including Antigen Leukocyte Antibody Test
Immunoassays for allergy testing, including Antigen Leukocyte Antibody Test (ALCAT®;
CPT 83516)
Medical necessity requirements
Allergy testing is coded with specific CPT codes and therefore, nonspecific
Immunoassay codes – which are used to describe a huge variety of tests across a
broad range of medical settings – have no role in allergy testing. Allergy Testing
The medical necessity of ALCAT has not been demonstrated.
o Immunoassays used for in vitro allergy testing in general, and ALCAT
specifically, are determined to be investigational and experimental. Such testing
is not eligible for reimbursement for any clinical indications.
Billing and reimbursement
Because immunoassays are billed with a procedure code that is not specific to
allergy or ALCAT testing, the following claim information will be used to identify
presumed allergy or ALCAT testing:
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o Claims from providers known to perform immunoassays for allergy testing,
which include, but are not limited to, Cell Sciences, Inc
o Claims for CPT code 83516 will be subject to post-service review when billed
with:
any allergy-related ICD code from any table in the ICD10 Codes section of
this policy, or
any allergy-related procedure code as defined in this policy, or
an unusually large number of units of CPT 83516
Diagnosis Codes
Diagnosis codes in this section may be used to support or refute medical necessity as
described in the above guidelines.
Table: ICD Codes Indicating Stinging Insect Venom Allergy Testing
Codes and descriptions
Code or Range Description
Z91.03X Insect allergy status
Table: ICD Codes Indicating Food Allergy Testing
Codes and descriptions
Code or Range Description
J30.5 Allergic rhinitis due to food
K52.2X Allergic and dietetic gastroenteritis and
colitis
K90.41 Non-celiac gluten sensitivity
L23.6 Allergic contact dermatitis due to food in
contact with skin Allergy Testing
L24.6 Irritant contact dermatitis due to food in
contact with skin
L25.4 Unspecified contact dermatitis due to food
in contact with skin
L27.2 Dermatitis due to ingested food
T78.0X Anaphylactic reaction due to food
T78.1X Other adverse food reactions, not
elsewhere classified
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Code or Range Description
Z91.01X Food allergy status
Z91.02 Food additives allergy status
Table: ICD Codes Indicating Inhalational Allergy Testing
Codes and descriptions
Code or Range Description
J30.0 Vasomotor rhinitis
J30.1 Allergic rhinitis due to pollen
J30.2 Other seasonal allergic rhinitis
J30.8X Other allergic rhinitis
J30.9 Allergic rhinitis, unspecified
J31.X Chronic rhinitis, nasopharyngitis and
pharyngitis
J32.X Chronic sinusitis
J39.3 Upper respiratory tract hypersensitivity
reaction, site unspecified
J45.X Asthma
J60-J70.X Lung diseases due to external agents
J82 Pulmonary eosinophilia, not elsewhere
classified
Table: ICD Codes Indicating Latex Allergy Testing
Codes and descriptions
Code or Range Description
Z91.040 Latex allergy status Allergy Testing
Table: ICD Codes Indicating Drug Allergy Testing
Codes and descriptions
Code or Range Description
L23.3 Allergic contact dermatitis due to drugs in
contact with skin
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Code or Range Description
L24.4 Irritant contact dermatitis due to drugs in
contact with skin
L25.1 Unspecified contact dermatitis due to
drugs in contact with skin
L27.0 Generalized skin eruption due to drugs
and meds taken internally
L27.1 Local skin eruption due to drugs and
meds taken internally
T88.6X Anaphylactic reaction due to adverse
effect of correct drug or medicament
properly administered
T88.7X Unspecified adverse effect of drug or
medicament
Z88.X Allergy status to drugs, medicaments and
biological substances
Table: ICD Codes Indicating Acute Contact Dermatitis Testing
Codes and descriptions
Code or Range Description
H01.11X Allergic dermatitis of eyelid
L20.X Atopic dermatitis
L23.0 Allergic contact dermatitis due to metals
L23.1 Allergic contact dermatitis due to
adhesives
L23.2 Allergic contact dermatitis due to
cosmetics
L23.4 Allergic contact dermatitis due to dyes Allergy Testing
L23.5 Allergic contact dermatitis due to other
chemical products
L23.7 Allergic contact dermatitis due to plants,
except food
L23.8X Allergic contact dermatitis due to other
agents
L23.9 Allergic contact dermatitis, unspecified
cause
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