Adding allergy to your practice

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Adding allergy to your practice Michael J. Parker, MD a, * , Jami Lucas b a Community General Hospital, Physicians Office Building North, Suite 35, Broad Road, Syracuse, NY 13215, USA b American Academy of Otolaryngic Allergy and Foundation, 1990 M Street NW, Suite 680, Washington, DC 20036, USA The practice of otolaryngology at the dawn of the twenty-first century is an exciting and, at times, trying experience. Numerous factors tug at the direction and scope of this specialty. As otolaryngologists enjoy greater freedom because of technologic and scientific advances, they are also faced with increasing restraints from ever-tightening managed care restrictions [1], reduced reimbursement [2], and increased exposure to litigation [3]. The national health care focus has demonstrated an increased awareness of chronic, long-term, high cost diseases. Although part of this shift results from extensive medical advances and an improved ability to manage chronic diseases, the real driving force behind this increased focus has been the cost associated with chronic disease and patients’ desire for improved quality of life. Otolaryngologists need to continue to provide the best possible services to their patients. Growing understanding of diseases that affect the head and neck has increasingly shown that allergy plays a key role in diseases such as rhinitis [4], otitis media [5,6], Meniere’s disease [7], and rhinosinusitis [8]. Otolaryngologists’ ability to blend the management of allergic disease into the general treatment of medical and surgical problems of the head and neck is core to their role as regional specialists who provide patients with optimal care. The general medical community [9], by better understanding the pathophysiology of the allergic process, has increasingly recognized allergy’s influence on diseases related to the head and neck and aerodigestive tract [10a]. The link between allergic disease and asthma, for example, has nicely demonstrated the benefits of treatment of allergic rhinitis symptoms and the associated improvement in pulmonary function. This example has helped to draw attention to the need for allergy management in the treatment of many Otolaryngol Clin N Am 36 (2003) 837–854 * Corresponding author. E-mail address: [email protected] 0030-6665/03/$ - see front matter Ó 2003 Elsevier Inc. All rights reserved. doi:10.1016/S0030-6665(03)00060-4

Transcript of Adding allergy to your practice

Page 1: Adding allergy to your practice

Otolaryngol Clin N Am

36 (2003) 837–854

Adding allergy to your practice

Michael J. Parker, MDa,*, Jami Lucasb

aCommunity General Hospital, Physicians Office Building North,

Suite 35, Broad Road, Syracuse, NY 13215, USAbAmerican Academy of Otolaryngic Allergy and Foundation,

1990 M Street NW, Suite 680, Washington, DC 20036, USA

The practice of otolaryngology at the dawn of the twenty-first century isan exciting and, at times, trying experience. Numerous factors tug at thedirection and scope of this specialty. As otolaryngologists enjoy greaterfreedom because of technologic and scientific advances, they are also facedwith increasing restraints from ever-tightening managed care restrictions [1],reduced reimbursement [2], and increased exposure to litigation [3]. Thenational health care focus has demonstrated an increased awareness ofchronic, long-term, high cost diseases. Although part of this shift resultsfrom extensive medical advances and an improved ability to manage chronicdiseases, the real driving force behind this increased focus has been the costassociated with chronic disease and patients’ desire for improved quality oflife. Otolaryngologists need to continue to provide the best possible servicesto their patients. Growing understanding of diseases that affect the head andneck has increasingly shown that allergy plays a key role in diseases such asrhinitis [4], otitis media [5,6], Meniere’s disease [7], and rhinosinusitis [8].Otolaryngologists’ ability to blend the management of allergic disease intothe general treatment of medical and surgical problems of the head and neckis core to their role as regional specialists who provide patients with optimalcare.

The general medical community [9], by better understanding thepathophysiology of the allergic process, has increasingly recognized allergy’sinfluence on diseases related to the head and neck and aerodigestive tract[10a]. The link between allergic disease and asthma, for example, has nicelydemonstrated the benefits of treatment of allergic rhinitis symptoms and theassociated improvement in pulmonary function. This example has helped todraw attention to the need for allergy management in the treatment of many

* Corresponding author.

E-mail address: [email protected]

0030-6665/03/$ - see front matter � 2003 Elsevier Inc. All rights reserved.

doi:10.1016/S0030-6665(03)00060-4

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aerodigestive tract diseases. With the increased recognition of allergy as acontributing factor comes a better understanding of the proper managementof many of these diseases. Allergy training has evolved to become an integralcomponent of most otolaryngology residency programs (RRC Website)[10b]. The American Board of Otolaryngology considers allergy a corecomponent of its resident curriculum [11,12].

The role of allergy treatment as a key element of a quality otolaryngologyresidency is also a direct result of the recognition of the tremendous healthand economic impact of allergic disease. Allergic disease is estimated toaffect between 17% and 22% of the population of the United States [13].Allergic rhinitis is the most common diagnostic code used in otolaryngology[10a]. Although allergy has a low mortality, its presence has a significantnegative effect on quality of life [14]. The economic effect, both direct andindirect, cannot be overstated. In 1995, the direct cost to manage symptomsof allergic disease was estimated to be 2.4 billion dollars; by 2001, annualcosts had swollen to $8 billion [15].

Given the link between allergy and upper respiratory disease, allergyshould be considered an integral part of the practice of otolaryngology.Otolaryngologists should consider allergy as a factor in many of thecommon diseases encountered in the head and neck. Whether each in-dividual otolaryngologist feels compelled to develop expertise in allergy issecondary; allergic disease and its ramifications must be considered in thedifferential diagnosis of diseases of the head and neck. Otolaryngologistsneed to have a basic knowledge of immunology, to be aware of appropriatemedical intervention, and to know when to seek help from either anotolaryngologic allergist or a general allergist.

The discussion of adding allergy to a practice involves the considerationof several responsibilities. Foremost, the physician who wishes to addallergy to his or her practice should be guided by safe and efficient patientmanagement techniques. To acquire these techniques, the physician needs toseek appropriate training at accredited Accreditation Council of GraduateMedical Education (ACGME) postgraduate courses such as those offeredby the American Academy of Otolaryngic Allergy (AAOA), a sister societyof the American Academy of Otolaryngology-Head and Neck Surgery(AAO-HNS). By successfully completing postgraduate courses in the studyof allergy, the physician can develop the skills necessary to recognize andtreat most aspects of allergic disease safely. It is expected that otolaryngol-ogists practicing allergy will continue with their studies and, with increasedexperience and added proficiency in the management of allergic patients,obtain Fellow status within the AAOA [16].

Physicians deciding to add allergy to their practices must commit to theirown training and also to the training of ancillary personnel. These personnelmust develop an adequate understanding of the allergic process and be ableto develop expertise as support staff for each appropriate aspect of patientmanagement such as patient education, environmental controls, pharma-

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cotherapy, and immunotherapy. The physician establishing an allergypractice needs to support its development with adequate time, space, andresources. The details of testing, antigen selection, vial preparation, andallergy treatment need to be considered. A comprehensive understanding ofinsurance coding and billing procedures is mandatory. Finally, each practicemust understand and be prepared to handle allergic emergencies.

Getting started

The addition of allergy to an otolaryngologic practice requires severalconsiderations. After an otolaryngologist has decided to add allergy to hisor her practice, has gained any needed additional training, and feelscomfortable with the concepts of managing the allergic patient, the next stepis to gain some experience by actually treating these patients. A good generalprinciple is to start slowly with a few patients who are straightforward intheir presentation so that both physician and ancillary staff gradually gainexperience. At first, treatment strategies considered cautious or conservativeshould be employed. With experience and confidence, additional testing andtreatment options can be added. Visiting an established practice to observethe clinical environment and see if there are any similar practice patterns isoften a useful first step. Some questions to ask are

1. What testing techniques are being used?2. How are patients routed thorough the office?3. What precautions are in place to treat emergencies?4. Where are supplies obtained?

Having a local resource to contact when routine questions arise isinvaluable. It is important to consider how establishing an allergy center willaffect the rest of an existing practice. Because the allergy practice is a newcost center, it is wise to implement a tracking system from the onset tomonitor the income, expenses, and patient volume directly related to allergymanagement and also the related diagnoses and procedures resulting fromthis new patient base. Starting slowly with respect to number of patientstested allows the physician and ancillary staff gain needed experience andexpertise gradually.

Ancillary staff

A critical aspect in the development of most successful allergy practices isthe proper selection and training of ancillary staff (Fig. 1). Ancillary staffrequirements vary greatly with respect to internal expectations and to statemedical regulations [17]. Each state has its own set of regulations for thelevel of certification required to perform specific duties. In general, thechoice among medical assistant, laboratory technician, licensed practi-cal nurse, registered nurse, and nurse practitioner is one that balances

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educational background and level of training with expected patientresponsibility and budgetary considerations. Each practice should attemptto define the anticipated role of the ancillary personnel so that eachindividual has the required level of training [18].

Several different options exist for assigning responsibilites for allergypatient care to the ancillary personnel. It may not be practical to havea dedicated allergy staff in a small office; instead, it may be more realistic torequire all nurses to share allergy responsibilities. When responsibilities areshared, however, additional precautions need to be implemented to allowcareful record keeping. Clear rules documenting all activities, includingprocedures, such as labeling and dating treatment vials and initialing vialmixes, are essential so that appropriate personnel can be contacted if anyspecific questions arise.

As the practice grows and becomes busier, many physicians decide toassign the responsibilities of ancillary allergy care exclusively to one or moreindividuals. Having a dedicated allergy staff person provides bettercontinuity of care, a closer nurse–patient relationship, and the opportunityfor that staff person to develop a better understanding of the principles ofallergy. The major disadvantage of a one-person allergy department occursduring that individual’s absence from the practice for vacation, illness, orjob change. These situations should be anticipated, and plans should be inplace in advance, with trained backup personnel.

Fig. 1. Ancillary personnel prepare vials.

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Whether allergy responsibilities are shared among the practice ormanaged by a dedicated allergy staff, the ancillary staff assigned to allergycare must certain characteristics: they should be personable, enjoy patientinteraction, be interested in learning, and have solid clinical observationskills. They should also have the ability to pay particular attention to detail,which is critical for safe vial preparation, correct dose administration, andappropriate monitoring of patient symptoms.

Ancillary personnel should also be able to act relatively independently.The decision to proceed with the weekly treatment of immunotherapytherapy (if indicated by patient symptoms) is a decision that well-trainedancillary support staff should be able to make independently. They shouldalso not feel pressured by time constraints to perform their duties, par-ticularly as it pertains to patient care, testing, or preparation of thetreatment vials.

As a service to its Physician Fellows and members, the AAOA provideseducational opportunities for ancillary personnel. The development ofa dedicated and proficient ancillary staff to support the practice of allergy ismandatory. As ancillary staff gain experience, they can gradually assumemore responsibilities. This increased staff responsibility does not relieve thephysician from the responsibility for ultimate management of the patient orthe overall control of the direction of the allergy practice.

The physician’s integral involvement is essential to the successful practiceof allergy. Medicare and Stark II regulations require direct physician in-volvement. ‘‘Services and supplies must be integral, although incidental,and part of the physician’s professional service. The clarification of thisstatement is that a physician must have been involved to determine atreatment plan for the particular patient in order for continued billable/covered services to be considered incident to’’ [18]. In allergy management,these regulations require direct personal physician supervision: the physicianmust be present in the office and immediately available to provide assistanceand direction throughout the time the employee or ancillary staff is per-forming services.

The practice of a physician, with minimal training or little interest inallergy, hiring ancillary staff with prior experience to ‘‘run the allergypractice’’ is indefensible. The physician is required to be directly involvedwith the provision of allergy services to assure quality patient managementand to comply with the ‘‘incident to’’ regulations [19].

Office requirements

Once education, training, support staff and resources, and ancillaryresponsibilities have been well thought out, one must consider the actualoffice space requirements for a successful allergy practice. An area dedicatedto the practice of allergy and rarely used for other reasons must be created

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within existing office space. In most cases, when an established officeinitiates an allergy practice, the space ends up being a compromise. Theabsolute minimal requirements are a dedicated refrigerator for antigen andvial storage, countertop space with a sink for mixing and liquid disposal(Figs. 2, 3), a testing chair with easy access to the patient’s arms, and an areaallowing patient privacy [20]. These minimal requirements might be met byconverting an infrequently used examination room. If the opportunityto create new space or truly to transform available space exists, severalimportant aspects should be considered.

One desirable feature of the well-thought-out otolaryngologic office isa separate entrance and waiting area for the allergy patients. Because of thespecial needs of the allergic patient, which might include chemical andfragrance sensitivities, it is useful to create an area on which the en-vironment can be controlled. The allergy waiting area might have a signasking patients not to wear any perfumes or scented deodorants. Thefurnishings should be wood or metal with minimal or no upholsteredcoverings. The floor should be without carpeting. If possible, the areashould have its own air handling system or at least a room air cleaner [21]. Aunique hypoallergenic environment can be created in the allergy waitingroom. The separation of allergic patients from patients in the regularpractice also leads to less questioning by nonallergy patients concerning the

Fig. 2. Example of minimal counter space required.

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perceived shorter waiting times of allergy patients there to receive aninjection.

Testing

As physicians begin to recognize allergy as a contributing factor ina number of diseases of the head and neck, the question frequently arises asto when it is appropriate to initiate testing for allergies. The simplest form ofallergy testing is nonspecific and involves history-driven environmentalcontrols or clinical pharmacologic trials. These imprecise testing techniquesprovide an additional level of suspicion concerning the presence or absenceof allergy. Insurance carriers in heavily managed-care environments oftenrequire evidence of allergic disease through a nonspecific treatment methodbefore allowing specific testing. These nonspecific techniques, such as anantihistamine trial or history-specific environmental avoidance, are fre-quently employed initially and are successful in some patients. Specifictesting, as it pertains to inhalant allergy, can be defined as attempts to detectthe presence of antigen-specific IgE. Such testing is generally undertakenbecause of the failure of nonspecific measures to control symptoms. Oncespecific testing is indicated, another important decision is which test-ing technique may be most effective in confirming the diagnosis of al-lergy. Several important factors are involved in this decision; the most

Fig. 3. Example of counter space for mixing vials and supplies.

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fundamental is the choice of in vivo or in vitro testing. Each testing methodhas several well-documented advantages and disadvantages [22–24]. Thebeginning otolaryngologic allergist should understand the concepts of skintesting (in vivo) and in vitro testing. Frequently, the beginning practitionerchooses the technique with which she or he feels more comfortable. Thisdecision is often influenced by the support and backup available during thestart-up period. It is common, as patient volume increases and the phy-sician’s experience improves, to add additional testing modalities, so thereis often a blending of techniques to arrive most efficiently at a successfuldiagnosis and a strategy for instituting therapy [25].

The goal of in vivo testing is to identify indirectly the presence of antigen-specific IgE molecules attached to mediator cells in the skin by directlyprovoking a patient responsewith each antigen exposure [26]. If in vivo testingis deemed the more suitable modality, several additional factors must beconsidered. First, the logistics of testing mandate the preservation of patientprivacy during testing. With the onset of stricter governmental regulationspertaining to patient privacy [20], additional efforts may be required tomaintain patient confidentiality. In vivo testing is also frequently the firstopportunity for the patient to be challenged with a potentially reactiveantigen. Any practice initiating in vivo testing needs to have a plan toimplement emergency measures if necessary [27]. With strict adherence toAAOA guidelines for in vivo antigen testing, systemic reactions during skintesting are rare [28,29].

Currently several recommended in vivo techniques are approved in theAAOA guidelines [28]. Skin prick testing (single or multiple pricks) is widelyused, safe, relatively well controlled, and has been used for some time [30].Skin prick testing is commonly used as a screening tool by otolaryngologicand general allergists [22]. It requires few supplies and has become relativelystandardized in its application, although some variation in interpretationexists [31]. Intradermal testing (single intradermal or intradermal dilutional)is also an acceptable method of skin testing and is frequently employed as anallergy testing technique (Fig. 4) [22]. Intradermal techniques require slightlymore technical expertise to apply the test dose but produce results that areeasily interpreted, more reproducible, and provide a higher sensitivity thanskin prick tests [32]. Dilutional intradermal testing (eg, venom intradermaldilutional techniques, serial endpoint titration [SET]) seems to be the mostquantitative [33] of the in vivo techniques, allowing the best determinationof a safe starting dose of immunotherapy for each antigen [34].

In vitro allergy testing has its own set of advantages and disadvantagesfor a beginning allergy practice. The reasons for vitro testing are similar tothose of in vivo testing; to measure antigen-specific serum IgE (in this casedirectly) [35]. A primary advantage of in vitro techniques is that no antigenis delivered to the patient during testing; thus the patient is not at risk fordeveloping reactions from testing. An additional advantage of in vitrotesting is the convenience of a single needle stick for drawing blood and the

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convenience for patients. Furthermore, patients about to undergo allergytesting by in vitro techniques do not need to modify their pharmacotherapyregimens before testing [22].

In vitro testing does have disadvantages. Additional space is required tohouse the equipment needed for a testing laboratory. The space require-ments for testing equipment vary with different manufacturers andanticipated testing volumes. In general, sufficient counter and storage spaceshould be made available away from active patient-flow areas. The es-tablishment of an office-based laboratory requires compliance with strictgovernmental oversight through Clinical Laboratories ImprovementAmendments (CLIA) regulations [36]. The need for laboratory space andfor meeting the CLIA requirements can be mitigated by using the services ofseveral nationally certified laboratories that routinely evaluate antigen-specific IgE levels for the diagnosis of allergic disease. In vitro results arereported in a classification system similar to that used for skin titrationtechniques and can provide a safe starting point for immunotherapy [37].Several technical differences exist among available in vitro systems, and thephysician should evaluate test accuracy, test reproducibility, availablesupport, and peer-reviewed articles comparing systems before decidingwhich system best suits the needs of the practice [38].

Several additional considerations remain when making the choice be-tween in vitro and in vivo testing. In several situations one testing technique

Fig. 4. Example of dilutional intradermal testing.

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is preferable to the other. Skin testing is contraindicated for patientswith significant eczema, urticaria, or dermatographism and for thoseunable to tolerate discontinuing the use of antihistamines [39]. Some antigensmay not be available for either in vitro or in vivo testing, and there are dif-ficulties with the binding of some antigens to the test medium for in vitrotesting [40]. Finally, physician or patient preference test choice may be over-ridden by insurance mandates.

Antigen selection

The choice of antigens for testing and treatment is also a crucial decision.Knowledge of relevant regional antigens is mandatory. If significant antigenicexposure is overlooked in the diagnostic phase, appropriate avoidance,pharmacotherapy, or immunotherapy cannot be successfully implemented.All significant seasonal and perennial exposures must be included in thescreening test. Reference sources for aeroantigen distribution include severaltextbooks [40,41], the AAOA website [16], the Pollen and Spore reports ofthe American Academy of Allergy, Asthma, and Immunology (AAAAI)[42], and material available from antigen supply houses.

Antigen screening

Once significant regional antigens have been identified, the use of anantigen-screening panel to confirm the presence of allergy must beconsidered. The antigen-screening panel is a cost-effective way to identifythe atopic patient. Testing each of the two most prevalent tree, grass, andweed pollens, dust mite allergen, appropriate molds, and animal dander,with positive and negative controls, is usually adequate to perform screeningfor allergic disease. In 1982, King [43] demonstrated the ability to obtain anefficient screening with sensitivity approaching 95% for the diagnosis ofallergy using only three pollens (the most prevalent tree, grass, and weedin the region), three molds, and those household perennials deemedappropriate. No significant improvement in diagnostic accuracy wasachieved by increasing the number of tests without specific patient exposurehistory. The specific antigens screened in any area will vary. The need to addadditional exposure-specific antigens should be well documented beforefurther testing is conducted. Once positive screening results are obtained,additional testing, if indicated, can be performed. Typically additionaltesting is driven by history, previous positive tests, and a desire to expose allsignificant positive antigens.

Treatment

Once allergy testing is completed, the patient and physician needto discuss the results and consider the treatment options: avoidance,

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pharmacotherapy, or immunotherapy. The patient should be presented withthe options specific to the positive antigens. Control of allergy symptomswith environmental controls and pharmacotherapy should always beconsidered first. Table 1 outlines some environmental interventions forcommon allergens.

The decision to proceed with immunotherapy should not be undertakenlightly, because immunotherapy carries a risk of a potentially life-threatening reaction [44]. If the decision is made to proceed with im-munotherapy, it is appropriate to discuss several issues relevant to theadministration of allergy shots. The patient beginning immunotherapyneeds to have realistic expectations about the anticipated outcome ofimmunotherapy, the frequency and duration of shots, and the potential risksand complications. An informed consent is appropriate at this time. Inaddition, a discussion of office and insurance billing procedures should takeplace, because embarking on a course of immunotherapy requires asignificant commitment of time and financial resources by the patient.Insurance participation and copayment requirements should be discussed.Any issues related to office injection scheduling, waiting room policies, andthe general timetable of immunotherapy should also be reviewed (eg, hourswhen injections are available, time required to stay after injections, new vialpreparation, vial testing, options for out-of-office therapy, availability ofhome-based therapy, sublingual therapy). The frequency of follow-upphysician visits should also be discussed. A typical schedule might includea visit with the physician at 6 weeks and then at 3-month intervals afterinitiating therapy to access progress (assuming the patient is progressingwithout complications).

Immunotherapy

The preparation of the multidose treatment vial is a crucial step in theprocess of delivering safe immunotherapy. During vial preparation, specificantigens to which the patient is sensitive are mixed together at con-centrations unique to each patient’s specific reactivity. Any variable thatinterferes with accurate vial mixing offers the opportunity to provide thepatient with something other than that which the patient has been proven tobe sensitive and could cause a dangerous reaction.

When vials are prepared internally, several factors need to be kept inmind. The necessity of those antigens tested being the same as those actuallyused for treatment cannot be overstated. In experienced hands, vials can beprepared safely and effectively. In many cases treatment can be institutedshortly after the decision to proceed with immunotherapy is made (assumingall necessary insurance issues have been addressed). Because of the need forfocused concentration during the vial preparation process, a location wherethe ancillary personnel can work uninterrupted is mandatory to lessen the

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Table

1

Commonindoorallergensandenvironmentalinterventions

Dust

mites

Reservoirs/habitats

Exacerbatingconditions

Interventions

Tokillmites

Toreduce

miteallergen

levels

Sheets

Blankets/comforters

Mattresses

Poorventilation/staticair

duringhouse

cleaning

70%

to90%

relativehumidity

Enclose

mattress,pillow,

andcomforter

in

imperviouscovers

Avoid

carpets

Provideventilationatthe

headofthebed

Pillows

Carpets(especially

wool)

77� F

–86� F

Place

electric

blanket

on

surface

ofmattress

on

highsettingfor8hours

Wash

beddingin

detergent

every1–2weeks

Reduce

timein

bedroom

Rough-smooth

floors

Furniture

stuffing

Wash

beddingandtreat

carpet

with

benzylbenzoate

every

1–2weeks

Wash

beddingin

detergent

every1–2weeks

Avoid

dust-collecting

furnishings

Wash

beddingin

waterat

1300� –140� F

every1–2

weeks

Avoid

cottonorwool

blankets

Avoid

roughfloors

Use

chlorinebleach

Vacuum

usingHEPA

Dry

cleaning

filters(then

leaveareafor

Tumble

dry

beddingat

140� F

for6hours

30minutes)

Dust

witha3%

tannic

acid

Freezeinfested

item

sfor

1–2days

solution

Use

aHEPA

mask

while

house

cleaningto

block

airborneallergen

Maintain

moderate

temperaturesandlow

humidityin

residence

Provideadequate

ventilation

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Resideatelevation[4000

feet

intemperate

clim

ate

Catsanddogs

Pet

managem

ent

Residence

managem

ent

Indoorresidencies,with

andwithoutpets

Petsin

the

neighborhood

Keeppetsoutofbedroom

Keeppetsoutofresidence

Wash

pets

Keepfemale

rather

than

Stayoutdoors

Reduce

orelim

inate

carpets

Minim

izefurnishings

Wipesm

ooth

surfaceswith

Carpets

Multiple

indoor

male

cat

dampcloth

Wipesurfaceswith3%

furnishings,especiallyif

hair-anddust-catching

tannic

acidsolution

Vacuum

often

withHEPA

filtration

Use

HEPA

airfiltrationas

supplement

Cockroaches

Pro-exposure

conditions

Kill/deter

cockroaches

Reduce

habitat

Kitchen

floors

Cubboards

Wateraccumulation

Foodparticlesnotcleaned

up

Apply

pesticide

Cleanregularly

Rem

ovefoodsources

before

nightfall

Rem

oveindoorstanding

water

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chance of any antigen being mixed incorrectly at the wrong dose or oferroneous antigens being added to a specific patient’s vial.

Vials can be prepared outside the office at commercial settings. Althoughthis procedure might seem convenient to the new allergy practitioner, itshould be discouraged for a number of reasons. Practices that are able tocomprehend and perform vial preparation successfully demonstrate a betterunderstanding of the entire treatment process. When vials are prepared off-site, treatment is often delayed because of the time needed to transport ormail the new vial. Additionally, because the source of the specific antigensmay be different, off-site preparation provides an opportunity for thoseantigens used in testing to have a bioavailability different from those used inthe treatment vial. A final consideration with regard to vial preparation isthat the mixing and preparation of the treatment vial is an insurance billableevent; as such, the company producing the vial should be the party typicallybilling for the service. This additional bill may add some confusion for thepatient with respect to the billing process. Medicare considers it illegal toobtain a vial from a third party and mark up the charge to the patient.

Once prepared, the first therapeutic dose of immunotherapy from eachtreatment vial should be preceded by a test dose (vial test). This test doseensures that each vial has a mixture that will be tolerated by the patient andnot provoke an initial significant reaction. The initial treatment dose fromeach vial is the dose most likely to provoke a reaction [45]. This higherobserved reaction rate results, in part, from the freshness and increasedpotency of the antigens in the vial mix. The possibility of improper mixing ofthe vial also contributes to an increased risk of a reaction on the firsttreatment dose. To mitigate this potential problem, a vial test (a 4-mmwheal, similar to a single intradermal test) is applied to the patient in-tradermally to check for any unsuspected response.

Once immunotherapy is instituted, a number of variables, includingphysician experience, patient availability, ability to tolerate dose advance-ment, and coseasonal effects, all play a role in ongoing therapy. The periodof time patients should be observed after receiving the injection varies, buttypically 20 minutes of observation is recommended; most significantreactions occur within this period [29]. Dose escalation should continue untila symptom-relieving dose or a maximum tolerated dose is reached. Sug-gestions for duration of therapy at maximal dose vary [29,46]. Differencesalso exist with regard to how long to maintain immunotherapy and how andwhen to begin to taper immunotherapy [29].

Emergencies

Any practice that initiates an immunotherapy program is incompletewithout having a plan in place for handling anaphylactic emergencies.Although rare, reactions can occur with testing or while initiating and

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escalating immunotherapy [29]. One of the most effective ways to minimizethis possibility is to be meticulous in each of the steps leading to the deliveryof immunotherapy. An understanding of the principles behind antigenselection, testing, vial preparation, and immunotherapy minimizes risk.Through the use of quantitative techniques, a safe starting point forimmunotherapy can be determined. Initiating therapy at a safe startingpoint minimizes the likelihood of provoking a reaction [29]. Attention todetails with regard to vial preparation, correct dosages, and avoidance oflabeling errors are all of utmost importance. By identifying and managingcarefully patients with an atypical presentation or who seem to be moresensitive, potential missteps can be avoided.

A detailed description of the treatment strategies for an anaphylacticreaction to immunotherapy is beyond the scope of this article, but severalguidelines should be mentioned. Each office should have in place a clearlywritten and displayed emergency plan. Emergency equipment should bereadily available, and a duty roster to identify and check for outdatedmedications and depleted oxygen supply should be in place. Key roles ofprimary responders and backup personal should be assigned in advance.Finally, a mock emergency should be scheduled on a regular basis orwhenever there is a significant change in personnel.

Coding and billing

Physicians should maintain copies of the most recent edition of theAmerican Medical Association (AMA)’s Current Procedural Terminology(CPT) book in their offices to assure that they are using the most currentcoding recommendations. According to the CPT codebook, a physicianmust bill using the definition or code that most closely defines which serviceswere performed. Based on the 2003 AMA CPT Code book [47], the mostcommon codes for otolaryngic allergy are

95004 Percutaneous tests (scratch, puncture, and prick) with allergenicextracts, immediate type reaction, specify number of tests

95024 Intracutaneous (intradermal) tests with allergenic extracts,immediate type reaction, specify number of tests

95027 Intracutaneous (intradermal) tests, sequential and incremental,with allergenic extracts for airborne allergens, immediate type reaction,specify number of tests (50)

95115 Professional services for allergen immunotherapy not includingprovision of allergenic extracts; single injection

95117 Professional services for allergen immunotherapy not includingprovision of allergenic extracts; two or more injections

95165 Professional services for the supervision of preparation andprovision of antigens for allergen immunotherapy; single or multipleantigens (specify the number of doses)

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86003 Allergen-specific IgE; quantitative or semiquantitative, eachallergen (in vitro)

The difference between 95024 intradermal testing and 95027 intradermaltesting is that 95024 is usually interpreted as limited to a single intradermaltest per antigen, whereas 95027 allows more than one test or stick perantigen, known as intradermal dilutional testing.

In recent years, Medicare has differed from the AMA and privateinsurance carriers in the interpretation as to what constitutes a dose for vialpreparation under code 95165. With Medicare alone, the current in-terpretation is that a billable dose is equivalent to 1 cm3, no matter what theclinical dose may be. The CPT assistant vignette and a recent Office of theInspector General study interpret a billable dose to be the amount drawn upin the syringe for the injection. One should confer with all the carriers withwhich one participates to obtain their billing and coding recommendationsin writing. Additionally, one should monitor one’s own billing andreimbursement patterns to help evaluate future participation with healthplans and to interpret the fiscal impact of allergy management services onthe overall practice.

Summary

The ability to blend the management of allergic disease into the generaltreatment of head and neck disease is core to the otolaryngologist’s role asregional specialist of the upper aerodigestive tract. Allergy training is nowconsidered an integral component of the residency curriculum established bythe American Board of Otolaryngology. By obtaining any needed additionaltraining through organizations such as the AAOA and by validating thateducation by obtaining fellowship status in the AAOA, the postgraduateotolaryngologist who adds allergy to his or her practice will find thetechniques to be safe, effective, and of great benefits to patients.

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