Department of Health and Human Services


OFFICE OF 

INSPECTOR GENERAL 

ALLERGEN IMMUNOTHERAPY

FOR MEDICARE BENEFICIARIES

Daniel R. Levinson


Inspector General 


February 2006


OEI-09-00-00531

Office of Inspector General 
 http://oig.hhs.gov 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, 

as amended, is to protect the integrity of the Department of Health and Human Services 

(HHS) programs, as well as the health and welfare of beneficiaries served by those 

programs. This statutory mission is carried out through a nationwide network of audits, 

investigations, and inspections conducted by the following operating components: 

Office of Audit Services 

The OIG's Office of Audit Services (OAS) provides all auditing services for HHS, either by 

conducting audits with its own audit resources or by overseeing audit work done by others. 

Audits examine the performance of HHS programs and/or its grantees and contractors 

in carrying out their respective responsibilities and are intended to provide independent 

assessments of HHS programs and operations in order to reduce waste, abuse, and 

mismanagement and to promote economy and efficiency throughout HHS. 

Office of Evaluation and Inspections 

The OIG's Office of Evaluation and Inspections (OEI) conducts management and 

program evaluations (called inspections) that focus on issues of concern to HHS, the 

Congress, and the public. The findings and recommendations contained in the 

inspections reports generate rapid, accurate, and up-to-date information on the 

efficiency, vulnerability, and effectiveness of departmental programs. The OEI also 

oversees State Medicaid fraud control units which investigate and prosecute fraud and 

patient abuse in the Medicaid program. 

Office of Investigations 

The OIG's Office of Investigations (OI) conducts criminal, civil, and administrative 

investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries 

and of unjust enrichment by providers. The investigative efforts of OI lead to criminal 

convictions, administrative sanctions, or civil monetary penalties. 

Office of Counsel to the Inspector General 

The Office of Counsel to the Inspector General (OCIG) provides general legal services to 

OIG, rendering advice and opinions on HHS programs and operations and providing all 

legal support in OIG's internal operations. The OCIG imposes program exclusions and 

civil monetary penalties on health care providers and litigates those actions within 

HHS. The OCIG also represents OIG in the global settlement of cases arising under the 

Civil False Claims Act, develops and monitors corporate integrity agreements, develops 

compliance program guidances, renders advisory opinions on OIG sanctions to the 

health care community, and issues fraud alerts and other industry guidance. 
Δ EXECUTIVE SUMMAR Y 

OBJECTIVE 

To determine (1) if allergen immunotherapy and related services met 

Medicare coverage and documentation requirements, and (2) if allergen 

immunotherapy provided to Medicare beneficiaries was of a quality that 

met professionally recognized standards of health care. 

BACKGROUND 

In 2001, Medicare allowed approximately $130 million for allergen 

immunotherapy and related services. By 2003, this amount had grown 

to $171 million. Allergen immunotherapy—commonly known as allergy 

shots—is intended to reduce the patient’s reactions to particular 

allergens. Title XVIII of the Social Security Act (the Act) limits 

Medicare coverage to services that are medically necessary (section 

1862(a)(1)(A)) and supported by documentation (section 1833(e)). Title 

XI of the Act requires that services provided to Medicare beneficiaries 

be of a quality that meets professionally recognized standards of health 

care (section 1156(a)(2)). Federal regulations (42 CFR § 1001.2) define 

“professionally recognized standards of health care” as “. . . Statewide or 

national standards of care . . . that professional peers of the individual 

or entity . . . recognize as applying to those peers practicing or providing 

care within a State.” 

The Joint Task Force on Practice Parameters, which represents 

95 percent of the allergist/immunologists in the United States, 

publishes standards of care for the diagnosis and treatment of allergies. 

These standards specify medical necessity criteria, contraindications, 

and the proper duration of allergen immunotherapy. They also outline 

procedures for administering allergy tests, preparing and delivering 

injections, and providing follow-up care. Because, to our knowledge, 

there exist no competing local or State standards for allergen 

immunotherapy, we considered the Joint Task Force standards to be 

“professionally recognized standards of health care” under section 

1156(a)(2) of the Act. 

As part of “Medicare Antigen Preparation” (OEI-09-00-00530), 

published in 2000, the Office of Inspector General evaluated a probe 

sample of allergy services. Based on medical review, most beneficiaries 

in the sample received substandard and poorly documented care. These 

concerns led us to contract with practicing allergists and 

otolaryngologists to review the medical records of a random cluster 

 OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES i 
EXE CUTIVE S U MMAR Y 

sample of 400 Medicare immunotherapy patients and 

1,434 allergen immunotherapy and related services they received in 

2001. We also contracted with a certified professional coder to 

determine if each service was documented adequately and billed with 

the correct code. 

FINDINGS 

Sixty-two percent of the allergen immunotherapy and related 

services allowed by Medicare in 2001 did not meet program 

requirements, resulting in $75 million in improper payments. Our 

medical reviewers found that 31 percent of allergen immunotherapy and 

related services allowed by Medicare in 2001 were not medically 

necessary (and, therefore, noncovered). These services generally were 

not indicated or were provided as part of an immunotherapy regimen 

that lasted longer than clinically acceptable. Furthermore, 7 percent of 

allergen immunotherapy and related services were billed with an 

incorrect code and 29 percent were undocumented. Six percent had 

multiple errors, yielding an overall error rate of 62 percent, resulting in 

$75 million in improper payments.1 

In the absence of national guidance, some carriers have adopted 

policies that diverge from professionally recognized standards of 

health care. National Medicare coverage and payment guidelines 

regarding allergen immunotherapy are very limited. In the absence of 

national guidelines, carriers have implemented policies that are 

sometimes inconsistent with Joint Task Force standards. For instance, 

at least one carrier allows reimbursement for injections given at home, 

although the standards clearly state that, because of the risk of adverse 

reactions, shots should be delivered only in a clinical setting. 

The care provided to approximately 70 percent of Medicare 

beneficiaries who received allergen immunotherapy in 2001 was 

inconsistent with professionally recognized standards of health 

care. In addition to the service-level review, our reviewers also 

examined the entire course of treatment for each beneficiary in our 

sample. In approximately 70 percent of cases, the reviewers found that 

some aspect of the beneficiary’s allergy testing or treatment departed 

significantly from one or more of the Joint Task Force standards. For 

1 Difference due to rounding. 

 OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES ii 
EXE CUTIVE S U MMAR Y 

example, 20 percent of beneficiaries on allergen immunotherapy did not 

have conditions for which allergy shots were appropriate or did not have 

allergy tests that showed reactions to any potential allergens. 

Treatment for 13 percent was contraindicated by concomitant conditions 

or the use of beta-blockers. Nearly 22 percent of beneficiaries received 

shots for longer than is acceptable, because they were not experiencing 

any clinical benefit or had been receiving shots for many years without 

being reassessed. Other examples include identified situations wherein 

beneficiaries received allergy tests that lacked proper controls, 

injections that were delivered in a nonclinical setting, and follow-up 

care that was too infrequent to adequately monitor the patient or 

involved unnecessary repeat allergy tests. 

RECOMMENDATIONS 

The large number of payment errors we found indicates that allergen 

immunotherapy is a significant Medicare vulnerability. That 

vulnerability has expanded as Medicare allowances for allergen 

immunotherapy and related services have increased since we conducted 

our inspection. To address this growing problem, we recommend that 

the Centers for Medicare & Medicaid Services (CMS): 

Require carriers to educate physicians who provide allergen 

immunotherapy to Medicare beneficiaries about coverage, coding, 

and documentation requirements. 

Develop national coverage criteria for allergen immunotherapy 

based on professionally recognized standards of health care. 

In addition to these recommendations, we have forwarded information 

on the medically unnecessary, miscoded, and undocumented services 

identified in our sample to CMS for appropriate action. 

AGENCY COMMENTS 

In its comments to our draft report, CMS stated that it is prepared to 

develop and disseminate educational materials and develop new 

coverage criteria for allergen immunotherapy services. CMS has 

identified two possibilities for developing national coverage criteria for 

allergen immunotherapy: adapting criteria directly from current 

professional society standards or opening a National Coverage 

Determination. CMS states that either option would require up to 12 

months to fully implement, and that educating physicians on existing 

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EXE CUTIVE S U MMAR Y 

coding, documentation, and coverage requirements depends on the 

course chosen for developing national coverage criteria. 

OFFICE OF INSPECTOR GENERAL RESPONSE 

We appreciate CMS’s support for our recommendations to increase 

physician education and to develop national coverage criteria based on 

professionally recognized standards of health care. Since the CMS 

letter identifies various methods for implementing the 

recommendations, we request that CMS provide to us an action plan 

that clarifies the specific steps it intends to take to fully implement the 

recommendations. 

 OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES iv 
Δ T ABLE OF CONTENTS 

EXECUTI VE SUMMARY ........................................ i

INTRODUCTI ON ................................................ 1 

FINDI NGS ....................................................... 7 

Improper payments of $75 million ............................. 7 

Medicare carrier policies diverge from professionally 

recognized standards ......................................... 9 

Seventy percent of beneficiaries’ care substandard ............. 10 

RECOM M E NDATI O NS ......................................... 15 

 Agency Comments .......................................... 15 

Office of Inspector General Response ......................... 15 

APPENDI XES .................................................. 17 

A: Professionally Recognized Standards of Care ............... 17 

B: Statistical Confidence Intervals and T-tests ................ 22 

C: Agency Comments ....................................... 26 

ACKN O W LEDGMENTS ......................................... 28 
Δ INTRODU C TION 

OBJECTIVE 

To determine (1) if allergen immunotherapy and related services met 

Medicare coverage and documentation requirements, and (2) if allergen 

immunotherapy provided to Medicare beneficiaries was of a quality that 

met professionally recognized standards of health care. 

BACKGROUND 

Allergies: What are they, and how are they diagnosed and treated? 

One in six Americans suffers from allergies—hypersensitive immune 

reactions to substances that are harmless to nonallergic people. Specific 

allergy triggers, or allergens, vary among sufferers, but commonly 

include animal dander, molds, pollens, and foods. Allergy symptoms 

range from mild respiratory irritation to anaphylaxis, a systemic and 

potentially fatal allergic reaction. 

An allergist2 uses allergy tests, along with his or her knowledge of 

possible environmental exposures and the patient’s history, to diagnose 

allergies and determine the substances to which a patient is allergic.3 

Prick and intradermal skin tests are the most widely used diagnostic 

tests, although blood tests and skin endpoint titration are sometimes 

used, particularly by otolaryngic allergists. Skin tests must be 

administered with positive and negative controls to properly interpret 

the patient’s reactions.4 

Several treatment options for allergies exist. If less costly measures are 

ineffective, the physician may start the patient on a program of allergy 

shots. In this treatment, also called allergen immunotherapy, a 

physician administers gradually increasing amounts of an extract 

containing one or more allergens until the patient reaches a 

maintenance dose. The patient’s symptoms should generally improve 

within 1 year of shots at the maintenance dose. If not, the physician 

should explore other treatment options. Since many patients experience 

2 Two types of specialist generally provide allergy care: allergist/immunologists and 

otolaryngic allergists. Both must undergo specialized training and examination. 

Allergist/immunologists provide the majority of Medicare allergy services. 

3 Joint Task Force on Practice Parameters. “Practice Parameters for Allergy Diagnostic 

Testing.” Annals of Allergy, Asthma, & Immunology. (1995;75:543-625) 

4 Joint Task Force on Practice Parameters. “Allergen immunotherapy: a practice 

parameter.” Annals of Allergy, Asthma, & Immunology. (2003;90:S1-S40) 

 OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES 1 
INTROD UCT ION 

a prolonged asymptomatic period after several years of successful 

immunotherapy, the physician should reevaluate the beneficiary’s need 

for continued treatment after 3 to 5 years of maintenance shots.5 

Allergy shots are generally safe, but involve a small risk of triggering 

adverse events, including anaphylaxis, and should be given only in a 

clinical setting appropriate for managing such reactions. Providers 

must be especially careful with the elderly, because older adults are 

more likely to have health problems or use medications that increase 

the risks associated with allergy shots. In particular, the use of betablockers can make anaphylaxis more severe and difficult to treat should 

it occur. Severe, uncontrolled asthma and significant cardiovascular 

disease also reduce a patient’s chance of surviving a systemic reaction to 

allergy shots. Immunotherapy for patients with such conditions is 

appropriate only if the benefits of treatment clearly outweigh the 

increased risks, e.g., the patient has a life-threatening venom allergy.6 

Medicare coverage of and requirements for immunotherapy services 

According to the National Claims History Data File, Medicare allowed 

$130 million for allergen immunotherapy and related services provided 

to 202,359 beneficiaries in 2001. As shown in Figure 1, $49 million was 

allowed for preparing allergen extracts and $51 million for injections, 

which are treated as distinct services for Medicare reimbursement.7 In 

FIGURE 1 

Medicare reimbursement 

Tests for allergen 

$12 million immunotherapy and 

related services 

Source: CMS National Claims History Data File, 2001 

Ancillary 

$12 million 

Extracts 

$49 million 

Injections 

$51 million 

Other 

Immunotherapy 

$6 million 

5 Ibid. 

6 Ibid. 

7 Normally, Medicare pays 80 percent of allowed charges, and the beneficiary pays the 

remaining 20 percent as coinsurance. 

 OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES 2 
INTROD UCT ION 

addition, Medicare allowed $12 million for allergy tests furnished to 

beneficiaries on allergy shots in 2001 and another $12 million for 

ancillary services, such as office visits, billed by the provider of an 

immunotherapy service. 

Provisions of the Social Security Act (the Act) and related regulations 

govern Medicare reimbursement of allergy services. Section 

1862(a)(1)(A) of the Act, implemented by 42 CFR § 411.15(k), limits 

Medicare coverage to services that are medically necessary. Section 

1833(e) of the Act, as reflected in 42 CFR § 424.5(a)(6), requires that 

providers furnish sufficient information to determine the amount due. 

In addition, section 1156(a)(2) of the Act requires that providers ensure 

that all health care services they bill to Medicare, including allergy 

services, are of a quality that meets professionally recognized standards 

of health care. “Professionally recognized standards of health care” are 

defined by 42 CFR § 1001.2 as “. . . Statewide or national standards of 

care . . . that professional peers of the individual or entity . . . recognize 

as applying to those peers practicing or providing care within a State.” 

The only national rules specific to Medicare coverage of allergen 

immunotherapy appear in the National Coverage Determinations 

Manual. Section 110.9 of the manual precludes reimbursement for 

allergen immunotherapy delivered via antigen drops placed under the 

tongue. Sections 110.11 and 110.13 limit certain types of testing and 

treatment for food allergies. Other Medicare manual sections provide 

rules for proper billing of allergy services, but contain no additional 

restrictions on coverage. In the absence of national rules, many carriers 

have instituted Local Medical Review Policies (LMRP) that address 

allergy services. 

The Joint Task Force on Practice Parameters develops standards for the 

diagnosis and treatment of allergies that embody generally accepted 

practices within the profession. The three societies that make up the 

Joint Task Force—the American Academy of Allergy, Asthma, and 

Immunology, the American College of Allergy, Asthma, and 

Immunology, and the Joint Council of Allergy, Asthma, and 

Immunology—represent an estimated 95 percent of the 

allergist/immunologists practicing in the United States, according to the 

chair of the Task Force. In 1995, the Task Force published “Practice 

Parameters for Allergy Diagnostic Testing,” which outlines the proper 

use of clinical and laboratory tests for allergies. “Allergen 

immunotherapy: a practice parameter [sic],” which was published in 

 OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES 3 
INTROD UCT ION

1996 and updated in 2003, provides standards for evaluating and 

treating allergic patients. The Joint Task Force standards specify 

medical necessity criteria for, contraindications to, and the appropriate 

duration of allergen immunotherapy. They also outline proper 

procedures for administering allergy tests, preparing and delivering 

injections, and providing follow-up care. Because, to our knowledge, 

there exist no competing local or State standards for allergen 

immunotherapy, we considered the Joint Task Force standards to be 

“professionally recognized standards of health care” under section 

1156(a)(2) of the Act. Appendix A lists the specific standards that are 

related to the findings in this report.8 

Prior Office of Inspector General work 

As part of “Medicare Allergen Preparation” (OEI-09-00-00530), 

published in 2002, we evaluated a probe sample of a small number of 

allergy services rendered to Medicare beneficiaries in 2000 and 2001. 

Seventeen of the twenty-seven services reviewed as part of this probe 

were inadequately documented or not medically necessary. 

Beneficiaries of the 12 services determined to be medically unnecessary 

had allergy test results that did not demonstrate the need for 

immunotherapy, had contraindications, or were on allergy shots for 

extended periods without clinical justification. 

METHODOLOGY 

Our primary methodology involved medical review of a sample of allergy 

services randomly selected from the Medicare 2001 National Claims 

History Date File. Because our objective required us to address both 

beneficiary- and service-level issues, we used a two-stage cluster sample 

to select records for the medical review. As diagramed in Figure 2 on 

the next page, we first defined the beneficiary universe as all Medicare 

beneficiaries on allergen immunotherapy in 2001, i.e., for whom at least 

one allergen immunotherapy service was allowed.9 From this universe 

8 The 2003 update clarified and expanded the standards that had been published in 1996. 

The allergy specialists who conducted the medical review for this study stated that the 

standards were considered “good practice” for many years prior to either publication. 

9 In defining the beneficiary universe, we regarded services listed under the heading 

“Allergen Immunotherapy” in the 2001 Current Procedural Terminology (CPT, codes 

95115 through 95199) as “allergen immunotherapy services,” except code 95180, Rapid 

desensitization procedure, each hour. We excluded CPT code 95180 because it is 

sometimes used to bill for an emergency procedure, rather than ongoing immunotherapy. 

OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES 4 
=

=

INTROD

FIGURE 2 

Graphical 

representation of the 

sample 

UCT ION 

of 202,359 beneficiaries, we selected 400 to create the beneficiary 

sample. Next, we defined the service universe as all Part B allergy and 

ancillary services allowed in 2001 for members of the beneficiary 

universe.10 The service universe comprised 4,325,670 services, with 

$130,388,941 allowed. To obtain the service sample, we randomly 

selected four services billed for each sampled beneficiary. Since some 

beneficiaries had fewer than 4 services allowed in 2001, our sample 

contained 1,434 services. 

Service Universe 

Allergy and ancillary services 

provided to beneficiary universe 

in 2001; N 4,325,670 

Beneficiary Universe

Beneficiaries on 

allergen immunotherapy 

in 2001; N 202,359 

Beneficiary 

sample 

n = 400 

Services provided to 

beneficiaries in sample 

# = 8,051 

Service 

sample 

n = 1,434 

Select 

up to 

4 per 

beneficiary 

Source: Office of Evaluation and Inspections, 2004 

After selecting the cluster sample, we requested medical records from 

all providers who billed at least one allergy service in 2001 on behalf of 

the sampled beneficiaries. We requested that each provider send all 

records related to each beneficiary’s allergy treatment, including the 

patient’s history and the results of allergy tests. We made at least two 

follow-up requests to each provider who did not respond to our initial 

request, for a total of three contacts. Our overall response rate was 

96 percent, because eight physicians did not respond to our repeated 

requests for records, and we chose not to contact eight others.

11 

10 For the service universe, we regarded services listed under the CPT headings “Allergy 

Testing” and “Allergen Immunotherapy” (CPT codes 95001 through 95199) as “allergy 

services” and services billed by the provider of an allergy service as “ancillary services.” 

11 One was under criminal investigation, one did not maintain records in English, two could 

not be located, and four had recently provided records for another allergy study. 

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INTROD UCT ION

We contracted with allergist/immunologists and otolaryngic allergists to 

review the records using a protocol we developed in collaboration with 

the medical reviewers.12 The protocol had two parts. First, the 

reviewers determined if the beneficiary’s allergy care as a whole met 

Joint Task Force standards. Then, the reviewers determined if each 

individual service in the sample was medically necessary. If the 

physician reviewer found that the beneficiary was an appropriate 

candidate for immunotherapy, a Certified Professional Coder then 

determined if each service was documented adequately and billed 

according to the definitions in the 2001 CPT Manual. We did not share 

the results of our review with the Medicare carriers that paid for the 

services. 

Along with the medical and coding reviews, we analyzed legislation, 

Medicare regulations, and Medicare and carrier LMRPs related to 

allergy services and compared them to the Joint Task Force standards. 

Because we reviewed only allergy and related services provided in 2001, 

our results cannot be extrapolated to other periods. Accordingly, we 

make no inferences to subsequent years. However, to our knowledge, 

the Centers for Medicare & Medicaid Services (CMS) has made no 

national policy changes that would impact the incidence of allergen 

immunotherapy payment errors since 2001. 

This study was conducted in accordance with the “Quality Standards for 

Inspections” issued by the President’s Council on Integrity and 

Efficiency and the Executive Council on Integrity and Efficiency. 

12 A physician of the same specialty as the beneficiary’s primary provider of allergen 

services reviewed each record. 

OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES 6 
Δ FINDINGS

Sixty-two percent of the allergen immunotherapy 

and related services allowed by Medicare in 2001 

did not meet program requirements, resulting in 

$75 million in improper payments 

Medicare allowed approximately 

$130 million in 2001 for allergen 

immunotherapy and related services. 

According to our medical review, 

31 percent of these services were not 

medically necessary (and, therefore, noncovered). An additional 

7 percent were miscoded and 29 percent were undocumented. Six 

percent had multiple errors, yielding an overall error rate of 

62 percent.13 Figure 3 groups the improperly paid services in our 

sample by the type of error and gives statistical projections of these 

errors to the population. 

Figure 3: Medically Unnecessary, Miscoded, and Undocumented Allergen 

Immunotherapy and Related Services 

Type of Error 

Sample Projected 

Services 

Allowed 

Amount 

Services 

(Proportion) 

Allowed Amount 

(Millions) 

Medically unnecessary 

- Not indicated 

- Excessive duration 

- (Both not indicated and 

excessive duration) 

208 

315 

(77) 

$ 7,170.58 

$ 10,566.99 

($ 1,965.31) 

0.15 

0.24 

(0.08) 

$ 17 

$ 22 

($ 6.5) 

Total medically unnecessary 446 $ 15,772.26 0.31 $ 33 

Total miscoded (net) 129 $ 2,577.84 0.07 $ 4.3 

Undocumented

 - Nonresponse 

- Missing documentation 

29 

404 

$567.13 

$23,311.64 

0.03 

0.26 

$2.2 

$42.5 

Total undocumented 433 $23,837.85 0.29 $45 

(Overlapping errors) (101) ($ 3,591.27) (0.06) ($ 6.4) 

Total 907 $ 38,596.68 0.62 $ 75 

Source: Medical Review of Year 2001 Allergen Immunotherapy and Related Services by Practicing Allergy

 Specialists. Lines may not sum to totals due to rounding. 

Medically unnecessary. Medical reviewers determined that 31 percent of 

the allergen immunotherapy and related services Medicare allowed in 

2001 were not medically necessary because immunotherapy was not 

indicated or the beneficiary had been on allergy shots for an excessive 

length of time. Immunotherapy services were more likely (34 percent) 

13 Confidence intervals for all statistics appear in Appendix B. 

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F I NDING S 

to be medically unnecessary than allergy tests (5 percent) or ancillary 

services (11 percent). 

Medically unnecessary: Not indicated. There was no clinical basis for 

approximately 15 percent ($17 million) of the allergen immunotherapy 

and related services that Medicare beneficiaries received. Medical 

reviewers determined that the allergy test results for 74 percent of 

these cases (i.e., of the 15 percent that did not have a clinical basis) did 

not indicate that the beneficiaries had any allergies, and 3 percent were 

not supported by any allergy test. The rest were not medically 

necessary because patient histories did not demonstrate that allergy 

shots were likely to alleviate the beneficiaries’ complaints or had never 

been completed. 

Medically unnecessary: Excessive duration. According to our reviewers, 

24 percent ($24 million) of allergen immunotherapy and related services 

were provided to beneficiaries for whom allergy shots were indicated 

originally, but whose duration of treatment exceeded Joint Task Force 

standards. The reviewers found some of these services to be medically 

unnecessary because the beneficiaries had not experienced any clinical 

benefits after 1 year of maintenance treatment. Other services were 

deemed unnecessary because the beneficiaries had been on 

immunotherapy for extended periods of time without evidence that such 

an extended course of immunotherapy was needed. 

Miscoded. In 2001, Medicare allowed approximately $13 million for 

allergen immunotherapy and related services that were billed with a 

code that did not accurately reflect the service provided.

14 If these 

services had been coded properly, Medicare would have allowed only 

$9 million, yielding an overpayment of $4 million. The most common 

error was billing CPT code 95117 (two or more injections of an allergen 

extract) when the documentation showed only one shot was provided. 

Other problems included billing for a greater volume of extract than 

was actually prepared or billing preparation of a multi-dose extract vial 

as preparation of a more expensive, single-dose vial. In several 

instances, physicians coded nonallergy services—including two lupron 

 OE I-09-00-00 531 

14 The Certified Professional Coder reviewed only services provided to Medicare 

beneficiaries who were appropriate candidates for allergen immunotherapy. Our 

projections for “miscoded” services, therefore, are actually projections for “miscoded 

services provided to beneficiaries who were appropriate candidates for allergen 

immunotherapy.” As a result, it is likely that we have underestimated the amount of 

money associated with miscoded allergy services. 

ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES 8 
F I NDING S 

injections, a vitamin B12 injection, and an echocardiogram—as allergy 

shots. 

Undocumented. We did not receive substantiating documentation for 

433 of the 1,434 services in our sample (29 percent). Despite repeated 

attempts, physicians did not provide any medical records for 29 of the 

services in our sample. The physicians who rendered another 404 of the 

services sent records that did not substantiate that any service was 

performed on the date claimed. Based on these findings, we estimate 

that Medicare allowed approximately $45 million in 2001 for 

undocumented allergen immunotherapy and related services. Although 

some cases of missing documentation may be attributable to billing 

errors (e.g., putting the wrong date on the claim form), others may 

represent services not rendered. In any case, claims for services that 

lack sufficient documentation to show that care was provided do not 

meet the requirements of section 1833(e) of the Act. 

Services billed with codes describing the preparation of immunotherapy 

extracts were undocumented most frequently. Although the Joint Task 

Force stresses the importance of documenting the contents of allergen 

extracts, 62 percent of these services lacked any substantiating 

documentation. 

In the absence of national guidance, 

some carriers have adopted policies that 

diverge from professionally recognized 

standards of health care 

As stated in the background, Medicare 

has little national coverage policy 

addressing allergen immunotherapy. In 

the absence of national guidance, many 

carriers have instituted LMRPs that 

address allergy-related issues. Some local, and even national, policies 

contradict the Joint Task Force standards. For example, section 110.11 

of the National Coverage Decisions Manual prohibits a particular, 

nontraditional, kind of immunotherapy for food allergies, but does not 

restrict the use of traditional immunotherapy for this purpose. The 

Joint Task Force standards, on the other hand, state that current 

scientific evidence does not support the use of any allergen 

immunotherapy modality in managing food allergies. 

Another example concerns patients who self-administer their allergy 

shots. Although the Joint Task Force standards clearly and strongly 

state that immunotherapy should not be given at home because of the 

risk of adverse reactions, no national Medicare policy addresses the 

issue. Most LMRPs are consistent with the Joint Task Force and 

 OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES 9 
F I NDING S 

indicate that shots should be provided in a setting appropriate for 

managing potential adverse reactions. However, one local policy states, 

“. . . it is expected that when the patient is stable on chronic therapy, 

[allergen immunotherapy] injections may be self-administered.”15 

The care provided to approximately 70 percent of 

Medicare beneficiaries who received allergen 

immunotherapy in 2001 was inconsistent with 

professionally recognized standards of health care 

In addition to examining the 

medical necessity and 

documentation of individual 

allergy services, our reviewers 

also assessed each beneficiary’s 

entire course of immunotherapy. Since national Medicare coverage 

rules for allergen immunotherapy are very limited, we compared 

beneficiaries’ treatment to the Joint Task Force standards for allergy 

testing and allergen immunotherapy. Overall, 30 percent of 

beneficiaries received care that met all Joint Task Force standards 

examined, 26 percent received care that did not meet standards related 

to one of the areas listed below, and 44 percent received care that did 

not meet standards related to two or more of these areas:16 

• clinical indications for immunotherapy (20 percent), 

• contraindications (13 percent), 

• duration of immunotherapy (22 percent), 

• allergy diagnostic testing (15 percent), 

• preparation and provision of injections (22 percent), and 

• follow-up care (44 percent). 

Approximately 20 percent of beneficiaries who received allergen 

immunotherapy services in 2001 had no clinical need for treatment 

“Allergen immunotherapy should be considered for patients who have 

demonstrable evidence of [reactivity] to clinically relevant allergens,” 

but the medical records for one in five beneficiaries lacked evidence that 

allergen immunotherapy was medically necessary.17 According to the 

15 Cahaba Government Benefit Administrators, Allergen Immunotherapy, L5390. 

16 In addition to the 16 beneficiaries for whom we did not receive records, 12 beneficiaries 

who were not actually on allergen immunotherapy in 2001 appeared in our sample, 

mostly as a result of billing errors. Hence, except where otherwise noted, we used a 

denominator of 372 beneficiaries on immunotherapy for the percentages in this finding. 

17 “Allergen immunotherapy: a practice parameter.” 

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F I NDING S 

patient histories that were available (9 percent of beneficiaries did not 

have a history in their record), 3 percent of beneficiaries on allergy shots 

had medical problems for which immunotherapy is not appropriate 

treatment. For example, several patients received allergy shots for 

chronic hives or angioedema (a type of swelling), although no clinical 

studies support treating these conditions with immunotherapy 

according to the Joint Task Force standards. Whether or not 

immunotherapy was appropriate for their complaints, 17 percent of 

Medicare immunotherapy patients did not show sufficient reactivity on 

their allergy tests to warrant treatment. The medical records for four of 

these beneficiaries contained no indication that they had ever received 

an allergy test. 

Thirteen percent of beneficiaries received immunotherapy despite 

contraindications that should have precluded it 

Approximately 13 percent of beneficiaries on immunotherapy had 

conditions for which our reviewers believed the attendant risk 

outweighed the potential benefit of allergy shots. The most common 

contraindications included taking beta-blockers and having 

compromised lung function. Other contraindications included a recent 

heart attack or arrhythmia, bypass surgery, chronic heart failure, 

prostate cancer, and previous stroke. Nearly 28 percent of the 

beneficiaries who received medically unnecessary immunotherapy also 

had contraindications. 

Approximately 22 percent of Medicare immunotherapy patients continued 

treatment well beyond clinical norms without justification 

The Joint Task Force standards state that if a patient has not 

experienced clinical improvement after 1 year of maintenance-dose 

immunotherapy, the physician should pursue other treatment options. 

Although approximately 9 percent of beneficiaries experienced no 

clinical benefit after several years of immunotherapy, they continued to 

receive shots on a regular basis. For example, one beneficiary remained 

on immunotherapy for 39 years, but still had significant allergy 

symptoms and needed numerous medications. 

The practice parameter also states that the physician and patient 

should reevaluate the need for continued immunotherapy every 3 to 

5 years. Seventeen percent of Medicare immunotherapy patients 

received shots for longer periods, with no indication in the medical 

record that the physician had ever considered discontinuing 

immunotherapy. At least 10 percent of Medicare beneficiaries had been 

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F I NDING S 

on allergy shots for 20 years or more without a reevaluation. In one 

extreme case, a beneficiary received continuous immunotherapy for 

47 years; the treating physician did not try new medications that had 

been developed during the 47 years, which may have eliminated the 

need for the shots. Also, the physician never attempted a trial cessation 

of immunotherapy, which our reviewers believed should have occurred 

in such a prolonged course of treatment. 

Fifteen percent of beneficiaries on immunotherapy received inappropriate 

allergy tests 

Based on “Practice Parameters for Allergy Diagnostic Testing,” 

approximately 6 percent of Medicare beneficiaries on immunotherapy 

received allergy tests to allergens to which they reported no exposure or 

for which allergen immunotherapy was not indicated. Some physicians 

administered skin tests for substances, such as bacteria or smog, for 

which skin testing is of unproven diagnostic value. Others tested 

beneficiaries with allergens to which they had little or no history of 

exposure. A few other beneficiaries received tests for multiple crossreactive allergens when a test for a single representative member of the 

allergen group would have sufficed.18 Approximately 2 percent were 

tested to an excessive number of potential allergens, especially foods. 

“This is a record for me: 141 prick skin tests and 91 intradermal tests,” 

wrote one reviewer. 

For the results of skin tests to be meaningful, they must be performed 

with appropriate controls and the test reagents must be provided at the 

correct strength.19 Physicians used incorrect procedures, however, to 

test about 1 of every 10 Medicare beneficiaries on immunotherapy in 

2001. The most common error was performing skin tests with no 

negative or positive controls, rendering accurate interpretation 

impossible. Physicians used reagents that were too strong for other 

tests, resulting in a high probability of false positive results. Physicians 

tested approximately 6 percent of beneficiaries using serial endpoint 

titration, a technique used primarily by otolaryngologists. Our 

reviewers stated that the physicians for 27 percent of these patients 

performed the technique or interpreted the results incorrectly. 

18 See Summary Statement 26 from “Allergen immunotherapy: a practice parameter” in 

Appendix A. 

19 “Practice Parameters for Allergy Diagnostic Testing.” 

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F I NDING S 

Twenty-two percent of beneficiaries received allergy shots that were 

prepared improperly, provided too frequently, or delivered in an 

inappropriate setting 

Approximately 8 percent of all Medicare immunotherapy patients 

received an allergen extract that was not prepared according to Joint 

Task Force standards. More than half of these extracts combined 

incompatible allergens or contained an excessive number of allergens, 

both of which can reduce treatment efficacy. Others contained allergens 

to which the beneficiary had tested negative or that had no correlation 

to the beneficiary’s allergy history. Some beneficiaries (2 percent 

overall) received extracts containing allergens, such as foods and poison 

ivy, for which immunotherapy is not indicated. 

Patients on a maintenance schedule should generally receive injections 

at 2- to 4-week intervals, but allergy shots were provided too frequently 

to approximately 11 percent of Medicare beneficiaries. Providers for 

these beneficiaries generally did not increase the amount of time 

between shots after a maintenance dosage was reached, which should 

normally be attempted, according to Joint Task Force standards. For 

example, one beneficiary received weekly shots for 28 years, without 

any indication that the physician ever tried longer intervals between 

shots. 

At least 7 percent of beneficiaries received their allergy shots at home 

despite Joint Task Force standards that state “immunotherapy 

injections should not be administered at home because of the risk of 

inadequate recognition and treatment of systemic reactions.”20 These 

beneficiaries administered their own shots or were treated by family 

members. According to the progress notes in her medical record, one 

beneficiary received shots “on the rode [sic]” in her mobile home. An 

additional 3 percent of beneficiaries received shots away from their 

allergy specialists’ offices, but in locations that were not identified in 

their medical records. 

20 “Allergen immunotherapy: a practice parameter.” 

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F I NDING S 

Some Medicare immunotherapy patients did not receive adequate follow-up 

care 

The Joint Task Force standards advise physicians to evaluate their 

immunotherapy patients every 6 to 12 months, but 24 percent of 

beneficiaries on allergy shots did not have regular follow-up visits with 

their allergy specialists. For example, one medical record showed that 

the patient had not seen her allergy specialist in more than 10 years. 

Another beneficiary, on immunotherapy for approximately 20 years, had 

no documented follow-up visits to his allergist. 

Even when conducted, followup was inappropriate for 27 percent of 

beneficiaries. For example, approximately 7 percent of patients had 

routine periodic skin tests without clinical justification—one beneficiary 

was inappropriately retested every time she had an exacerbation of her 

symptoms and another had skin tests at least nine times during a 

6-year period. Other providers made no note of the beneficiary’s 

response to immunotherapy or did not respond appropriately to changes 

in the beneficiary’s symptoms or the results of reevaluations. 

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ΔR E C O MMENDA T I O N S 

 RECOMME NDA TIONS 

Allergen immunotherapy services, while valuable, often are provided in 

an inappropriate manner and result in a significant number of improper 

Medicare payments. As allowances for allergen immunotherapy and 

related services have increased from $130 million in 2001 to 

approximately $171 million in 2003, so has Medicare’s vulnerability to 

related payment errors. Also, current national Medicare policy on 

immunotherapy is limited, and some national and local policies do not 

reflect current professionally recognized standards of health care. 

Therefore, we recommend that CMS: 

Instruct its carriers to educate physicians who provide allergen 

immunotherapy to Medicare beneficiaries about existing coding, 

documentation, and coverage requirements 

Develop national coverage criteria for allergen immunotherapy that are 

based on professionally recognized standards of health care 

In addition to these recommendations, we have forwarded information 

on the medically unnecessary, miscoded, and undocumented services 

identified in our sample to CMS for appropriate action. 

AGENCY COMMENTS 

In its comments to our draft report, CMS stated that it is prepared to 

develop and disseminate educational materials and develop new 

coverage criteria for allergen immunotherapy services. CMS has 

identified two possibilities for developing national coverage criteria for 

allergen immunotherapy: adapting criteria directly from current 

professional society standards or opening a National Coverage 

Determination. CMS states that either option would require up to 

12 months to fully implement,and that educating physicians on existing 

coding, documentation, and coverage requirements depends on the 

course chosen for developing national coverage criteria. The complete 

text of CMS’s comments are included starting on page 26. 

OFFICE OF INSPECTOR GENERAL RESPONSE 

We appreciate CMS’s support for our recommendations to increase 

physician education and to develop national coverage criteria based on 

professionally recognized standards of health care. Since the CMS 

letter identifies various methods for implementing the 

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R E C O MMENDA T I O N S 

recommendations, we request that CMS provide to us an action plan 

that clarifies the specific steps it intends to take to fully implement the 

recommendations. 

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Δ APPENDIX A 

Professionally Recognized Standards of Care 

We compared the findings of our medical review with the professionally 

recognized standards of health care found in the 2003 version of 

“Allergen immunotherapy: a practice parameter” and “Practice 

Parameters for Allergy Diagnostic Testing.” Although “Allergen 

immunotherapy” was updated in 2003, our contracted allergy specialists 

stated that the standards therein were considered “good practice” for 

many years prior, and are, therefore, applicable to services provided in 

2001. 

“Allergen immunotherapy” expresses the standards as a series of 

“summary statements,” each addressing a single topic related to 

immunotherapy. “Allergy Diagnostic Testing” consists primarily of 

similar one- or two-sentence guidelines. The particular summary 

statements and guidelines relevant to our analysis are quoted below. 

“Allergen immunotherapy: a practice parameter” 

Summary Statement 9. Immunotherapy is effective for treatment of 

allergic rhinitis, allergic asthma, and stinging insect hypersensitivity. 

Therefore, immunotherapy merits considerations in patients with these 

disorders. 

Summary Statement 10. Clinical studies to date do not support the use of 

allergen immunotherapy for food hypersensitivity, chronic urticaria, 

and/or angioedema. Therefore, allergen immunotherapy for patients 

with these conditions is not recommended. 

Summary Statement 11. Clinical parameters, such as symptom scores and 

medication use, may be useful measures of the efficacy of 

immunotherapy in a clinical setting. Routine periodic skin testing or in 

vitro IgE antibody testing of patients receiving immunotherapy is not 

recommended. 

Summary Statement 14. Patients taking β-adrenergic blocking agents 

may be at increased risk when receiving immunotherapy, because 

[beta]-receptor blockade can make treatment of anaphylaxis more 

difficult. Therefore, [beta]-adrenergic blocking agents are relative 

contraindications for immunotherapy. 

Summary Statement 15. Medical conditions that reduce the patient’s 

ability to survive a systemic reaction are relative contraindications for 

allergen immunotherapy. Examples include severe asthma 

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APP E N D I X ~A 

uncontrolled by pharmacotherapy and significant cardiovascular 

disease. 

Summary Statement 16. Allergen immunotherapy should be administered 

in a setting where procedures that can reduce the risk of anaphylaxis 

are in place and where the prompt recognition and treatment of 

anaphylaxis are assured. 

Summary Statement 17. Allergen immunotherapy should be considered 

for patients who have demonstrable evidence of specific IgE antibodies 

to clinically relevant allergens. The decision to begin allergen 

immunotherapy depends on the degree to which symptoms can be 

reduced by avoidance and medication, the amount and type of 

medication required to control symptoms, and the adverse effects of 

medications. Patients who wish to avoid or reduce the long-term use of 

medications are good candidates for immunotherapy. 

Summary Statement 18. Patients with severe, poorly controlled asthma 

are at higher risk for systemic reactions to immunotherapy injections. 

Summary Statement 21. The components of a clinically relevant vaccine 

(and, therefore, a vaccine that is most likely to be effective) should be 

selected on the basis of a careful history of relevant symptoms, 

knowledge of possible environmental exposures, and correlation with 

positive tests for specific IgE antibodies. 

Summary Statement 22. The immunotherapy vaccine should contain only 

clinically relevant allergens. 

Summary Statement 23. Immediate-type skin testing has been the 

primary diagnostic tool in clinical studies of allergen immunotherapy. 

Therefore, in most patients, skin testing should be used to determine 

whether the patient has specific IgE antibodies. Appropriately 

interpreted and well performed [sic] in vitro tests for specific IgE 

antibodies may also be used. 

Summary Statement 24. Immunotherapy is effective for pollen, fungi 

(molds), animal dander, dust mite, cockroach, and Hymenoptera 

sensitivity. Therefore, immunotherapy should be considered as part of 

the management program in patients who have symptoms related to 

exposure to these allergens and in whom the presence of specific IgE 

antibodies has been established. 

Summary Statement 25. In the mixing of an allergen vaccine, the 

following factors must be considered: (1) the cross-reactivity of the 

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APP E N D I X ~A 

allergens, (2) the optimal dose of each constituent, and (3) enzymatic 

degradation of the allergens. 

Summary Statement 26. The selection of allergens for immunotherapy 

should be based in part on the cross-reactivity of clinically relevant 

allergens. Many related pollen contain allergens that are cross-reactive. 

When pollen allergens are substantially cross-reactive, selection of a 

single pollen within the cross-reactive genus or subfamily may suffice. 

When pollen allergens are not substantially cross-reactive, testing for 

and treatment with multiple locally prevalent pollen [sic] may be 

necessary. 

Summary Statement 27. The efficacy of immunotherapy depends on 

achieving an optimal therapeutic dose of each of the clinically relevant 

constituents in the vaccine. 

Summary Statement 28. Separation of aqueous extracts (vaccines) with 

high proteolytic enzyme activities (e.g., fungi, dust mites, cockroach, 

and insect venoms) from other extracts (vaccines) is recommended. 

Summary Statement 43. When the patient has reached a maintenance 

dose, the interval between injections can often be progressively 

increased as tolerated to 4 to 6 weeks. 

Summary Statement 44. Clinical improvement usually is observed within 

1 year after the patient reaches a maintenance dose. 

Summary Statement 45. Patients should be evaluated at least every 6 to 

12 months while they receive immunotherapy. 

Summary Statement 46. A decision to continue or stop immunotherapy 

should be made after 3 to 5 years. 

Summary Statement 47. The vaccine contents, informed consent for 

immunotherapy, and administration of vaccines should be carefully 

documented. 

Summary Statement 48. The preferred location for the administration of 

allergen immunotherapy is the office of the physician who prepared the 

patient’s vaccine. 

Summary Statement 49. Generally, patients at high risk of systemic 

reaction should receive immunotherapy in the office of the physician 

who prepared the patient’s vaccine. 

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APP E N D I X ~A 

Summary Statement 50. Regardless of location, allergen immunotherapy 

should be administered under the supervision of an appropriately 

trained physician and personnel. 

Summary Statement 51. Immunotherapy injections should not be 

administered at home because of the risk of inadequate recognition and 

treatment of systemic reactions. 

Summary Statement 55. In older adults, medications and co-morbid 

medical conditions may increase the risk from immunotherapy. 

Therefore, special consideration must be given to the benefits and risks 

of immunotherapy in older adults. 

“Practice Parameters for Allergy Diagnostic Testing” 

• To properly interpret allergy skin tests that detect immediate 

hypersensitivity, both positive (histamine) and negative (diluent) 

controls need to be performed. 

• The appropriate clinical indications for retesting may include 

changing symptoms, new exposures, 3 to 5 years of venom 

immunotherapy or evaluation of newly discovered, purified, or 

standardized allergens. 

• Avoidance measures and extract formulations for 

immunotherapy should be based on the skin tests coupled with 

adequate clinical correlation, i.e., integrating with the history 

and physical findings obtained by face-to-face contact with the 

patient. 

• A prick/puncture skin test wheal response of at least 3 mm (with 

equivalent erythema) > than the diluent control done at the 

same time is required as proof of the presence of allergen specific 

IgE. 

• The larger the prick/puncture skin test reaction, the more likely 

it is to be of clinical significance. However, the presence of a 

positive prick/puncture skin test per se does not establish 

whether clinical sensitivity currently is present. 

• As a general rule, the starting test dose of intracutaneous 

extract solutions in patients with a preceding negative 

prick/puncture test should range between 100 and 1,000 fold 

dilutions of the prick/puncture test solution. 

• Any reaction larger than the negative control may indicate the 

presence of specific IgE antibody. However, given the lower 

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APP E N D I X ~A 

specificity of intracutaneous testing, small positive reactions 

may not be clinically relevant. 

• The evaluation of inhalant allergy may require up to 

70 prick/puncture tests followed by up to 40 intracutaneous 

tests, which are ordinarily performed when prick/puncture tests 

are negative. Under special circumstances and in certain 

geographic areas, a greater number of prick/puncture and/or 

intracutaneous tests may be appropriate. However, in many 

parts of the country and probably in most cases, fewer tests are 

required. 

• The number of prick/puncture tests performed for suspected food 

hypersensitivity may vary from less than 20 to as many as 

80 tests, depending on the clinical situation. 

• . . . for such agents as newsprint, formaldehyde, tobacco smoke, 

smog, cotton, sugar, and human dander, there is insufficient 

evidence to justify their use as allergen test reagents. 

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Δ APPENDIX B 

Statistical Confidence Intervals 

Statistic N Point Estimate 95% Confidence Interval 

Percentage of immunotherapy-related services that should 

not have been paid 1,434 0.62 0.56 to 0.67 

Amount that Medicare should not have allowed 1,434 $75 million $68 million to $82 million 

Percentage of services that were not medically necessary 1,434 0.31 0.26 to 0.37 

Amount allowed for medically unnecessary services 1,434 $33 million $26 million to $39 million 

Percentage of immunotherapy services that were not 

medically necessary 

1,243 0.34 0.28 to 0.40 

Percentage of allergy tests that were not medically 

necessary 

32 0.05 < 0.11 

Percentage of ancillary services that were not medically 

necessary 

127 0.11 0.04 to 0.19 

Percentage of services for which immunotherapy was not 

indicated 1,434 0.15 0.10 to 0.20 

Amount allowed for services where immunotherapy was not 

indicated 1,434 $17 million $12 million to $22 million 

Of services for which immunotherapy was not indicated: 

 -the percentage for which allergy tests did not show 

reactivity 

 -the percentage for which no allergy test was documented 

 -the percentage for which the patient’s history did not 

indicate immunotherapy 

208 

208 

208 

0.74 

0.03 

0.35 

0.56 to 0.91

< 0.08 

0.18 to 0.53 

Percentage of services that were allowed for beneficiaries 

on immunotherapy too long 1,434 0.24 0.18 to 0.30 

Amount allowed for services provided to beneficiaries on 

immunotherapy too long 1,434 $22 million $17 million to $28 million 

Percentage of services that were miscoded 1,434 0.07 0.05 to 0.10 

Excess amount allowed for miscoded services 1,434 $4.3 million $2.4 million to $6.1 million 

Total amount allowed for miscoded services 1,434 $13 million $8.8 million to $17 million 

 OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES 22 
APP E N D I X ~B 

Statistical Confidence Intervals, continued 

Statistic N Point Estimate 95% Confidence Interval 

Percentage of services that were undocumented 1,434 0.29 0.24 to 0.34 

Amount allowed for undocumented services 1,434 $45 million $37 million to $52 million 

Percentage of extract preparations that were undocumented 357 0.62 0.52 to 0.72 

Total percentage of beneficiaries whose care did not meet 

standards 372 0.70 0.65 to 0.75 

Percentage of beneficiaries whose care met standards 372 0.30 0.25 to 0.35 

Percentage of beneficiaries whose care failed standards in 

one area 372 0.26 0.22 to 0.31 

Percentage of beneficiaries whose care failed standards in 

multiple areas 372 0.44 0.39 to 0.49 

Percentage of beneficiaries on shots who had no 

demonstrated need for treatment 

372 0.20 0.16 to 0.24 

Percentage of beneficiaries who had contraindications 372 0.13 0.10 to 0.17 

Percentage of beneficiaries on immunotherapy too long 372 0.22 0.18 to 0.26 

Percentage of beneficiaries whose allergy tests did not meet 

standards 372 0.15 0.11 to 0.19 

Percentage of beneficiaries whose allergy shots were 

prepared or delivered inappropriately 

372 0.22 0.18 to 0.27 

Percentage of beneficiaries who received inadequate 

follow-up care 372 0.44 0.39 to 0.49 

Percentage of beneficiaries who did not have a patient 

history in their record 

372 0.09 0.06 to 0.12 

Percentage of beneficiaries who had complaints for which 

immunotherapy is not appropriate 

372 0.03 0.01 to 0.04 

Percentage of beneficiaries whose allergy tests did not 

indicate a need for treatment 

372 0.17 0.14 to 0.21 

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APP E N D I X ~B 

Statistical Confidence Intervals, continued 

Statistic N Point Estimate 95% Confidence Interval 

Percentage of with contraindications who: 

- were on beta-blockers 50 0.36 0.23 to 0.49 

- had compromised lung function 50 0.18 0.07 to 0.29 

Of beneficiaries whose treatment was unnecessary, the 

percentage that also had contraindications 74 0.28 0.18 to 0.39 

Percentage of beneficiaries who should have terminated 

immunotherapy because it did not benefit them clinically 

372 0.09 0.06 to 0.11 

Percentage of beneficiaries who were on immunotherapy 

too long without justification 

372 0.17 0.13 to 0.20 

Percentage of beneficiaries on immunotherapy longer than 

20 years 372 0.10 0.07 to 0.13 

Percentage of beneficiaries who were tested to 

inappropriate allergens 

372 0.06 0.03 to 0.08 

Percentage of beneficiaries who were tested to too many 

allergens 

372 0.02 0.01 to 0.04 

Percentage of beneficiaries who were tested with incorrect 

procedures 

372 0.10 0.07 to 0.14 

Percentage of beneficiaries who were tested with skin 

endpoint titration 

372 0.06 0.04 to 0.08 

Percentage of skin endpoint titrations that were performed 

or interpreted incorrectly 

22 0.27 0.09 to 0.46 

Percentage of beneficiaries whose shots contained 

inappropriate allergens 

372 0.08 0.06 to 0.11 

Percentage of beneficiaries whose shots contained allergens 

for which immunotherapy is not indicated 

372 0.02 0.01 to 0.04 

Percentage of beneficiaries who received shots too 

frequently 

372 0.11 0.08 to 0.14 

 OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES 24 
APP E N D I X ~B 

Statistical Confidence Intervals, continued 

Statistic N Point Estimate 95% Confidence Interval 

Percentage of beneficiaries who received shots at home 372 0.07 0.05 to 0.10 

Percentage of beneficiaries who received shots in an 

undetermined location 

372 0.03 0.01 to 0.04 

Percentage of beneficiaries whose treatment was not 

monitored 

372 0.24 0.19 to 0.28 

Percentage of beneficiaries who were monitored, but 

received inappropriate follow-up 

312 0.27 0.22 to 0.32 

Percentage of beneficiaries who received inappropriate 

repeat skin tests 

372 0.07 0.05 to 0.10 

Pairwise T - Tests for medically unnecessary services by type of service 

Comparison Test Result P-value 

(Bonferroni threshold = 0.016667) 

Allergy tests versus allergen immunotherapy -6.59 0.00 (significant at 95% confidence) 

Allergy tests versus ancillary services -1.37 0.17 (not significant at 95% confidence) 

Allergen immunotherapy versus ancillary services 5.10 0.00 (significant at 95% confidence) 

 OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES 25 
Δ APPENDIX C 

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APP E N D I X ~C 

 OE I-09-00-00 531 ALLER G E N I M M U N OTHERAP Y F O R ME D I CARE BENE F ICI A R I ES 27 
Δ ACKNOWLEDGMENTS 

This report was prepared under the direction of Paul A. Gottlober, 

Regional Inspector General for Evaluation and Inspections in the San 

Francisco regional office, and Deborah Harvey, Assistant Regional 

Inspector General. Other principal Office of Evaluation and Inspections 

staff who contributed include: 

Scott Hutchison, Project Leader 

Pamela J. Minniear, Program Analyst 

Camille Harper, Program Analyst 

Cheryl Dotts, Program Assistant 

Stephanie London, Program Specialist 

Bambi Straw, Program Specialist 

Tricia Davis, Director, Medicare and Medicaid Branch 

Technical Assistance 

Rob Gibbons, Program Analyst 

Scott Horning, Program Analyst 

Linda Moscoe, Program Analyst 

Barbara Tedesco, Mathematical Statistician 

We would like to thank our medical review contractor and the 

individual physicians who performed the review as well as the carrier 

staff who participated in our interviews and assisted us in obtaining 

contact information for the physicians whose claims were selected for 

review. 

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