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Rationale for Specific Allergen Testing of Patients With Asthma in the Clinical Pulmonary Office SettingOffice Allergen Testing FREE TO VIEW

Edward S. Schulman, MD, FCCP; Carol Pohlig, RN, CPC, ACS
Author and Funding Information

From the Division of Pulmonary, Critical Care and Sleep Medicine (Dr Schulman), Department of Medicine, Drexel University College of Medicine; and Department of Medicine (Ms Pohlig), University of Pennsylvania Health System, Philadelphia, PA.

CORRESPONDENCE TO: Edward S. Schulman, MD, FCCP, Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Drexel University College of Medicine, Mail Stop 107, 245 N 15th St, Philadelphia, PA 19102; e-mail: edward.schulman@drexelmed.edu


FUNDING/SUPPORT: Support for third-party writing assistance for this article was provided by Genentech, Inc, and Novartis Pharmaceuticals.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2015;147(1):251-258. doi:10.1378/chest.12-0072
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Asthma is a chronic inflammatory disease that affects an estimated 25 million people in the United States. In 70% to 90% of cases, asthma is associated with IgE-mediated mechanisms, which have proved central to allergen-induced inflammation in preclinical and clinical models. The importance of IgE levels in patients with moderate to severe asthma has been confirmed in randomized controlled studies with a targeted IgE blocker. Advances in laboratory methods to detect and quantify allergen-specific IgE antibodies have allowed for a quick-and-easy diagnosis of allergic IgE-mediated sensitivities in the office. Pulmonologists tend to order in vitro tests to measure allergen-specific IgE rather than to perform allergen skin testing, which is seen as the purview of allergists. This article reviews the importance of allergen testing in patients with asthma—whether by skin testing or by in vitro methods—and highlights the advantages, limitations, and interpretation of results derived from each method. Additionally, this article includes suggested documentation and administrative details for physician reporting in the office setting.

Figures in this Article

Asthma affects approximately 25 million people in the United States and is frequently responsible for unscheduled health-care usage and missed school days and workdays.1 Population-based studies have shown that asthma is closely and significantly related to total serum IgE levels.2 Most asthma is allergic and depends on allergen-specific IgE, the synthesis of which is regulated by exposure to specific allergens.3

The respiratory clinician should consider exposure and sensitivity to inhaled allergens in patients with asthma. This information is critical for recommending allergen avoidance education and identifying patients for therapies that may better address the allergic basis of asthma.4 Therefore, a complete asthma evaluation must pose questions about symptoms elicited by exposures to inhaled allergens, such as school and occupational allergens (eg, latex exposures), perennial (year-round) aeroallergens (ie, dust mites, molds, cats, dogs, cockroaches), and seasonal allergens. Failure to treat comorbid allergic rhinitis increases subsequent asthma-related ED visits and hospitalizations.5

Specific allergen testing can further strengthen and correlate a patient’s clinical history of symptoms with exposure (ie, sensitivity) and with allergen-specific IgE (sensitization). A determination of allergy based solely on clinical history frequently is discordant with evidence obtained from skin testing or in vitro serologic assays, with accuracy ranging from < 50% (and in some cases < 25%) in adults4 and 50% to 65% in children.6 Therefore, clinical history remains the final arbiter.

Testing and treatment can be costly in a private office setting. Physicians should select the appropriate testing code and the proper method for reporting the number of tests performed on a given date.

This article reviews the importance of allergen testing in patients with asthma and examines the advantages and limitations of the available testing methods. In addition, the billing options for these tests and suggestions for documentation in the pulmonology office setting are discussed.

The initial binding of antigen-specific IgE to mast cell and basophil receptors sensitizes these cells for subsequent allergen exposure.7,8 Allergen reexposure causes cross-linking of receptor-bound IgE, the immediate release of histamine and other granular-associated preformed mediators, and synthesis and release of lipid mediators, including leukotrienes and prostaglandins.8,9

IgE was identified > 40 years ago as a cornerstone of allergy and as fundamental to both in vivo and in vitro allergy testing.10,11 More recently, IgE has become a pharmacologic target. Omalizumab, a recombinant, humanized, monoclonal antibody that binds specifically to freely circulating IgE is approved for treatment of moderate to severe allergic asthma.8,1216

The National Asthma Education and Prevention Program practice guidelines recognize that indoor and outdoor allergen exposure in sensitized patients with asthma increases symptoms and precipitates asthma exacerbations.17 The guidelines state the need to ascertain whether patients with asthma are being exposed to inhalant allergens and recommend reducing or avoiding exposure where possible.17 The GINA (Global Initiative for Asthma) guidelines indicate that persistence of symptoms, despite treatment with inhaled corticosteroids, signals a need for allergen testing (if not previously performed) and consideration of immunotherapy.18 Depending on the clinical setting, either skin or in vitro tests should be performed (Table 1) and viewed as objective confirmatory tools to support or make unlikely a clinical history of symptoms following exposure to a suspected allergen. Of note, tests ordered in the absence of clinical history may commonly yield false-positive results and, rarely, false-negative results. Allergy tests thoughtfully ordered and properly evaluated can help to form a basis for a treatment plan, including immunotherapy.19,20

Table Graphic Jump Location
TABLE 1 ]  Selection of Allergen Test May Depend on the Setting

(Adapted with permission from Emanuel.19)

Allergen Skin Testing

Allergen skin testing confirms the presence of an antigen-specific IgE antibody and determines whether the antibody mediates an allergic response. In a positive skin test result, mast cells present in the skin release histamine, which produces wheal and flare responses. Specific allergens chosen based on the patient’s history as well as region of residence or travel are introduced using either the puncture (prick) skin test or intradermal skin test. In the prick-puncture method, allergen extracts concentrated > 1,000-fold higher than used for intradermal testing are placed on the skin and introduced into the epidermis with an assortment of devices. In the intradermal method, the allergens are injected into the dermis through a hypodermic syringe and needle. The prick-puncture method is considered simpler, faster, and more economical; produces less discomfort; is more specific; and produces rare false-positive results. Intradermal tests are more sensitive and have fewer false-negative reactions but correlate less well with symptoms (less specific). For these reasons, the skin prick-puncture tests are recommended over intradermal tests as the primary tests for the diagnosis of IgE-mediated allergic diseases by the Joint Council of Allergy, Asthma & Immunology.21 In both tests, the response to allergen is evaluated after 15 to 20 min as the wheal and erythema reach a defined or maximum diameter.20,21 False-negative and false-positive results can occur; therefore, saline and histamine should be used as negative and positive controls, respectively.20,21

When billing for the tests, physicians should select the most appropriate Current Procedural Terminology (CPT) code for skin testing based on the method used: 95004 (percutaneous tests [scratch, puncture, prick] with allergenic extracts, immediate type reaction, including test interpretation and report, specify number of tests), 95024 (intracutaneous [intradermal] tests with allergenic extracts, immediate type reaction, including test interpretation and report, specify number of tests), or 95027 (intracutaneous [intradermal] tests, sequential and incremental, with allergenic extracts for airborne allergens, immediate type reaction, including test interpretation and report, specify number of tests). The number of tests provided should be reported in the “units” field of the claim form. CPT codes 95004 and 95024 represent testing typically involving one stick, or test, per allergen, and physicians may report the total number of tests performed during a single testing session (eg, bill code 95004 × 14 units when administering testing for 14 allergens). Alternatively, code 95027 involves multiple sticks per allergen, but physicians may still report the total number of tests per allergen (eg, bill code 95027 × 42 units when three incremental dilutions are administered for 14 allergens). In effect, physician interpretation and reporting are required for each code. Although no standardized documentation guidelines exist regarding allergy testing, the Joint Council of Allergy, Asthma & Immunology provides a sample skin test form that includes a section for skin test interpretation.22

To comply with billing guidelines for allergy testing, the physician must provide direct supervision, which requires his or her presence in the office suite but not necessarily in the patient room during testing.23 Claim submission occurs in the physician’s name if a mid-level provider (eg, nurse practitioner, physician assistant) renders the service without physician supervision; claim submission occurs in the nonphysician provider’s name if he or she is enrolled with the payer. If any other qualified individual (eg, registered nurse) provides the service without physician supervision, the service may not be billed. Moreover, additional licensure and medicolegal risks may arise from this latter practice.

In addition to billing for testing, physicians may report an office consultation (CPT codes 99241-99245) or a new patient visit (CPT codes 99201-99205) for initial evaluations that plan for patient testing, even if testing is performed on the same day. The service can be considered a consultation if the evaluation occurs at the request of another health-care provider seeking opinion or advice and the consulting physician both documents the request and provides a written report to the requesting physician. If these consult requirements (request, reason, report) are not satisfied, the service is considered a new patient visit. Medicare and some other payers no longer pay for consultation codes; thus, physicians must report new patient visit codes for initial evaluations. If testing occurs on a day subsequent to the initial evaluation, an evaluation and management (E/M) service can only be reported for a medically necessary reason above and beyond the testing, such as reported symptoms of increased wheezing, which require a new or revised plan of care. An E/M service should not be reported with allergy testing merely because the patient requires posttest monitoring or standard posttest instruction in the absence of allergic reactions because these elements are inherent in testing.

In Vitro Assays

Most pulmonary practices rely solely on serologic in vitro tests to define the patient’s atopic status. The radioallergosorbent test (Fig 1A) was the first such test developed in 1968.20 Allergens bound to a solid-phase support (allergosorbent) were incubated with the patient’s serum and then washed. Bound IgE antibody was detected using a radiolabeled human anti-IgE.20,24 Higher radioactive counts indicated a higher level of allergen-specific IgE in the serum. Today, this assay is mostly obsolete. Several autoanalyzers now allow reproducible and quantitative total and allergen-specific IgE assay measurements in serum with the use of nonradioactive colorimetric or fluorometric markers.2426 The two widely used assays are ImmunoCAP (Thermo Fisher Scientific Inc [formerly Phadia]) and Immulite (Siemens Healthcare Diagnostics Inc). Both offer enhanced sensitivity down to 0.1 kUa/L, with excellent specificity and reproducibility (Fig 1B).19 The ImmunoCAP, for example, uses an arbitrary division of the United States into 19 geographic regions (Fig 2). Each panel tests 13 to 25 of the most common aeroallergens specific to that region along with total IgE.27 The grading of the allergen-specific responses and their clinical relevance are shown in Table 2. The class I to VI grading system used in some assays is now considered obsolete in favor of using kUa/L. The serologic systems are not interchangeable, and caution should be exercised in comparing and interpreting results.

Figure Jump LinkFigure 1 –  Schematic of in vitro tests: A, Radioallergosorbent test.20 B, ImmunoCAP. 125I = iodine-125; S = sorbent.Grahic Jump Location
Figure Jump LinkFigure 2 –  Allergen panel in ImmunoCAP is based on region of the United States. The ImmunoCAP for each region includes cat dander, dog dander, cockroach, house dust mite, and several mold (Alternaria alternata, Aspergillus fumigatus, and Cladosporium herbarum) allergens plus other allergens specific to that region.27Grahic Jump Location
Table Graphic Jump Location
TABLE 2 ]  Determining Clinical Relevance of Allergen-Specific IgE From In Vitro Testing
a 

Quantitative reporting of serum allergen-specific IgE using kUa/L has made reporting with the class system obsolete.

b 

In the ImmunoCAP system, 1 International Unit = 2.4 ng serum IgE.

The measurement of serum total IgE should be considered an adjunct to allergen-specific IgE antibody testing because high levels indicate a high probability of allergen sensitization.28 Low total IgE levels (< 30 IU/mL), however, do not preclude sensitivity to allergens,28 and symptomatic patients should still be tested by skin or in vitro tests. In patients with allergic rhinitis but without asthma, total IgE levels provide relatively little new information beyond that obtained from skin testing or serologic evaluation for the presence of IgE antibody to common aeroallergens.2

Physician billing for in vitro testing is somewhat limited. The laboratory reports the serum analysis with the most appropriate CPT code: 86003 (allergen-specific IgE; quantitative or semiquantitative, each allergen), 86005 (allergen-specific IgE; qualitative, multiallergen screen [dipstick, paddle, or disk]), 82785 (gammaglobulin; IgE), and so forth. In most cases, the physician may only bill for the specimen collection. Blood collected by venipuncture should be reported as code 36415 in addition to any E/M service (eg, 99204 and 36415 are separate line items on the claim form), as appropriate. Specimen collection by fingerstick (CPT code 36416) is not reported separately from any physician service provided on the same day.

There are advantages and disadvantages associated with both types of allergen-specific IgE testing (Table 3). Because of its sensitivity and rapidity, allergen skin testing is considered the allergist’s method of choice.21,22 Positive skin test results have been associated with increased asthma severity in several studies in both children and adults, but this depends on the allergen and patient population (Fig 3).2931

Table Graphic Jump Location
TABLE 3 ]  Comparison of Allergen Skin Test vs In Vitro Assay
Figure Jump LinkFigure 3 –  Frequency of positive skin test results for dust mite, cat dander, and dog dander in a cohort of 28 patients with severe asthma and 26 age- and sex-matched patients with mild asthma. *P < .001 mild vs severe asthma. †P < .0001 mild vs severe asthma. (Adapted with permission from Tunnicliffe et al.31)Grahic Jump Location

Unfortunately, standard criteria have not been established for defining the sensitivity and specificity of allergen skin tests or in vitro assays.19 Although comparisons between the two methods have been reported, the results have been generally concordant for most aeroallergen specificities, and any differences reflect the underlying immunologic basis of each test.32 Skin testing measures mast cell-bound IgE, whereas in vitro tests measure circulating IgE levels.32 In general, the sensitivity of in vitro testing may be lower but is more specific and produces fewer false-positive results than allergen skin testing.19

A complete environmental history of allergen exposure is critical to correctly interpret in vitro test results. In some cases, allergen-specific IgE testing or total IgE levels may be inconsistent with the patient’s history. In these instances, repeat in vitro testing should be considered, or allergen sensitivity should be evaluated by an alternative, such as skin testing. For example, an allergist can perform skin testing with high concentrations of a defined mix of allergens, such as tree mix or grass mix, to identify whether a component in the mix is responsible for symptoms. The specific component can then be identified by further skin testing using individual components of the mix.

Once sensitivity to specific allergens has been demonstrated, patients should be educated about strategies for avoiding and reducing allergen exposure. For dust mites, bedding should be washed weekly in hot water (54°C) and dried in a hot dryer to kill the bugs. Pillows, mattresses, and box springs require allergen-proof casings, and the house should be thoroughly cleaned.33 Pesticide use followed by improved cleaning practices are important for cockroach allergens, an important cause of childhood asthma. Patients who are sensitized to cat or dog allergens should not live with a pet inside their home. Less effective and salutary is to use high-efficiency particulate air filters and restrict pets from a safe room, which is typically the bedroom, to help to minimize contact.33 If allergen-specific immunotherapy is considered, it is important to determine whether the patient actually has symptoms of sensitivity to that particular allergen.34

When patients return to the medical office to review these strategic measures, physicians may report a separate E/M service. Reviewing test results is not part of the previously billed allergy testing. Because educational efforts are the focus of the visit, the physician may select the visit level (eg, CPT code 99214) based on counseling and coordination of care time. To qualify for time-based reporting, the physician must dedicate > 50% of the total visit time (ie, the total time the physician spends face to face with the patient in the office) to counseling.35 The physician documents the total visit time, the amount of time spent counseling and coordinating care, and the corresponding details, noting the level of patient comprehension and response (eg, 15 of 25 min spent reviewing reduction of controllable environmental risk factors).

Counseling provided by nonphysician providers should be reported differently from physician services. CPT code 99211 should be used for any medically necessary counseling provided by qualified allied health professionals, regardless of their total time spent with the patient. This code requires physician presence in the office at the time the service is rendered. Mid-level providers (eg, nurse practitioners, physician assistants) are not restricted from selecting the visit level that appropriately corresponds to their total visit time; the mid-level provider should submit the claim with his or her National Provider Identifier if enrolled with the insurer. A list of total visit times and associated office visit codes is provided in Table 4.

Table Graphic Jump Location
TABLE 4 ]  Total Visit Times

CPT = Current Procedural Terminology.

Omalizumab may be an option for adults and adolescents aged ≥ 12 years who have moderate to severe asthma, a positive skin or in vitro test result in response to a perennial aeroallergen, and symptoms not adequately controlled by inhaled corticosteroids. The dose and frequency of administration (every 2 or 4 weeks) of omalizumab is based on the initial total IgE levels (≥ 30-700 IU/mL) and body weight.16

Physicians providing services in the office setting can bill for both components of the injection service: the administration and the agent. For insurance coverage, prior authorization is usually required. Because it is identified as a recombinant, humanized, monoclonal antibody, some payers may have previously advised that CPT code 96401 (chemotherapy administration, subcutaneous or intramuscular; nonhormonal antineoplastic) best represents the administration service.36 However, Medicare and non-Medicare contractors currently suggest CPT code 96372 for proper coding of the administration.3739 In addition to the administration, physicians report J2357 (injection, omalizumab, 5 mg) for the agent. One unit should be reported for every 5 mg used. For example, if 150 mg is provided in one injection, code J2357 × 30 units should be indicated on the claim form. Because billing guidelines may vary, the physician should check with each payer’s policy or obtain written instruction regarding the best way to report the administration of omalizumab.

Most patients with asthma, particularly those presenting with severe or difficult-to-treat disease in a pulmonary setting, should undergo specific allergen testing. Pulmonologists should ask appropriate questions to get a sense of which allergens may trigger a patient’s allergic responses. Confirmation of allergen sensitivity can then be made with accurate and reproducible detection of allergen-specific IgE either by allergen skin testing or in vitro assay. Improvements in asthma management may result from information on allergen sensitivity, recommending allergen avoidance, reduction strategies, use of preventive treatments, and blockage of IgE with omalizumab. When indicated, the pulmonologist should also consider referral to an allergist for specific allergen immunotherapy.

Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Schulman has served as a consultant for Genentech, Inc, and Teva Respiratory. Ms Pohlig is editor, Pulmonology Coding Alert; associate editor and contributing author, Coding for Chest Medicine 2009; contributing writer, The Hospitalist (official publication of the Society of Hospital Medicine); and national and specialty board member, Board of Medical Specialty Coding.

Role of sponsors: The sponsors assisted in developing the concept of the article and the Figure 1 artwork.

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Figures

Figure Jump LinkFigure 1 –  Schematic of in vitro tests: A, Radioallergosorbent test.20 B, ImmunoCAP. 125I = iodine-125; S = sorbent.Grahic Jump Location
Figure Jump LinkFigure 2 –  Allergen panel in ImmunoCAP is based on region of the United States. The ImmunoCAP for each region includes cat dander, dog dander, cockroach, house dust mite, and several mold (Alternaria alternata, Aspergillus fumigatus, and Cladosporium herbarum) allergens plus other allergens specific to that region.27Grahic Jump Location
Figure Jump LinkFigure 3 –  Frequency of positive skin test results for dust mite, cat dander, and dog dander in a cohort of 28 patients with severe asthma and 26 age- and sex-matched patients with mild asthma. *P < .001 mild vs severe asthma. †P < .0001 mild vs severe asthma. (Adapted with permission from Tunnicliffe et al.31)Grahic Jump Location

Tables

Table Graphic Jump Location
TABLE 1 ]  Selection of Allergen Test May Depend on the Setting

(Adapted with permission from Emanuel.19)

Table Graphic Jump Location
TABLE 2 ]  Determining Clinical Relevance of Allergen-Specific IgE From In Vitro Testing
a 

Quantitative reporting of serum allergen-specific IgE using kUa/L has made reporting with the class system obsolete.

b 

In the ImmunoCAP system, 1 International Unit = 2.4 ng serum IgE.

Table Graphic Jump Location
TABLE 3 ]  Comparison of Allergen Skin Test vs In Vitro Assay
Table Graphic Jump Location
TABLE 4 ]  Total Visit Times

CPT = Current Procedural Terminology.

References

Asthma statistics. American Academy of Allergy, Asthma & Immunology website. http://www.aaaai.org/about-the-aaaai/newsroom/asthma-statistics.aspx. Accessed December 20, 2012.
 
Burrows B, Martinez FD, Halonen M, Barbee RA, Cline MG. Association of asthma with serum IgE levels and skin-test reactivity to allergens. N Engl J Med. 1989;320(5):271-277. [CrossRef] [PubMed]
 
Novak N, Bieber T. Allergic and nonallergic forms of atopic diseases. J Allergy Clin Immunol. 2003;112(2):252-262. [CrossRef] [PubMed]
 
Williams PB, Ahlstedt S, Barnes JH, Söderström L, Portnoy J. Are our impressions of allergy test performances correct? Ann Allergy Asthma Immunol. 2003;91(1):26-33. [CrossRef] [PubMed]
 
Crystal-Peters J, Neslusan C, Crown WH, Torres A. Treating allergic rhinitis in patients with comorbid asthma: the risk of asthma-related hospitalizations and emergency department visits. J Allergy Clin Immunol. 2002;109(1):57-62. [CrossRef] [PubMed]
 
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