Department of Health and Human Services

OFFICE OF 

INSPECTOR GENERAL 

A I
LLERGEN  MMUNOTHERAPY

M B
FOR  EDICARE  ENEFICIARIES

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.    E X E C U T I V E   S U M M A R 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 immunotherapycommonly known as allergy 
shotsis intended to reduce the patients 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 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  i  E X E C U T I V E   S U M M A R 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 beneficiarys allergy testing or treatment departed 
significantly from one or more of the Joint Task Force standards.  For 
1 Difference due to rounding. 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  ii  E X E C U T I V E   S U M M A R 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 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  iii  E X E C U T I V E   S U M M A R Y  
coding, documentation, and coverage requirements depends on the 
course chosen for developing national coverage criteria. 
OFFICE OF INSPECTOR GENERAL RESPONSE  
We appreciate CMSs 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. 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  iv    T A B L E   O F   C O N T E N T S  

EXECUTIVE SUMMARY ........................................  i

INTRODUCTION ................................................ 1 

FINDINGS ....................................................... 7 

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

Medicare carrier policies diverge from professionally 

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

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

RECOMMENDATIONS ......................................... 15 

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

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

APPENDIXES .................................................. 17 

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

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

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

ACKNOWLEDGMENTS ......................................... 28 
   I N T R O D U C T I O N  

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 allergieshypersensitive 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 patients 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 patients 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 patients 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) 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  1  I N T R O D U C T I O N  
a prolonged asymptomatic period after several years of successful 
immunotherapy, the physician should reevaluate the beneficiarys 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 beta-
blockers can make anaphylaxis more severe and difficult to treat should 
it occur.  Severe, uncontrolled asthma and significant cardiovascular 
disease also reduce a patients 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  Extracts 
$12 million 
immunotherapy and 
 $49 million 
Other 
related services 

Immunotherapy 
$6 million 
Injections 
$51 million 
Ancillary 
$12 million 
Source:  CMS National Claims History Data File, 2001 
5 Ibid. 
6 Ibid. 
7 Normally, Medicare pays 80 percent of allowed charges, and the beneficiary pays the 
remaining 20 percent as coinsurance. 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  2  I N T R O D U C T I O N  
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 Forcethe American Academy of Allergy, Asthma, and 
Immunology, the American College of Allergy, Asthma, and 
Immunology, and the Joint Council of Allergy, Asthma, and 
Immunologyrepresent 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 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  3  II NN TT RR OO DD UU CC TT II OO NN
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. 
OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  4  I N T R O D
 U C T I O N  
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. 
FIGURE 2 
Graphical 
representation of the 
Service Universe 
sample 
Beneficiary Universe Allergy and ancillary services 
Beneficiaries on  provided to beneficiary universe 
allergen immunotherapy  in 2001; N = 4,325,670 
in 2001; N = 202,359 
Services provided to 
beneficiaries in sample 
Beneficiary  # = 8,051 
sample 
Service 
n = 400  Select 
up to  sample 
4 per  n = 1,434 
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 beneficiarys allergy treatment, including the 
patients 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. 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  5  II NN TT RR OO DD UU CC TT II OO NN
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 beneficiarys 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 Presidents Council on Integrity and 
Efficiency and the Executive Council on Integrity and Efficiency. 
12 A physician of the same specialty as the beneficiarys primary provider of allergen 
services reviewed each record. 
OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  6    F I N D I N G S

Sixty-two percent of the allergen immunotherapy  Medicare allowed approximately 
and related services allowed by Medicare in 2001  $130 million in 2001 for allergen 
immunotherapy and related services. 
did not meet program requirements, resulting in 
According to our medical review, 
$75 million in improper payments  
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 
Sample  Projected 
Allowed  Services  Allowed Amount 
Type of Error  Services  Amount  (Proportion)  (Millions) 
Medically unnecessary 
- Not indicated  208  $ 7,170.58  0.15  $ 17 
- Excessive duration  315  $ 10,566.99  0.24  $ 22 
- (Both not indicated and 
(77)  ($ 1,965.31)  (0.08)  ($ 6.5) 
excessive duration) 
Total medically unnecessary  446  $ 15,772.26  0.31  $ 33 
Total miscoded (net)  129  $ 2,577.84  0.07  $ 4.3 
Undocumented
    - Nonresponse  29  $567.13  0.03  $2.2 
- Missing documentation  404  $23,311.64  0.26  $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. 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  7  F I N D I N G 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 servicesincluding two lupron 
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. 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  8  F I N D I N G S  
injections, a vitamin B12 injection, and an echocardiogramas 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,  As stated in the background, Medicare 
some carriers have adopted policies that  has little national coverage policy 
addressing allergen immunotherapy.  In 
diverge from professionally recognized 
the absence of national guidance, many 
standards of health care 
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 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  9  F I N D I N G 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  In addition to examining the 
Medicare beneficiaries who received allergen  medical necessity and 
documentation of individual 
immunotherapy in 2001 was inconsistent with 
allergy services, our reviewers 
professionally recognized standards of health care 
also assessed each beneficiarys 
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. 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  10  F I N D I N G
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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 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  11  F I N D I N G
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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 cross-
reactive 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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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 beneficiarys 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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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 justificationone 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 beneficiarys 
response to immunotherapy or did not respond appropriately to changes 
in the beneficiarys symptoms or the results of reevaluations. 
OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  14  R E C O M M E N D A T I O N S  
  R E C O M M E N D A T I O N S  

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 Medicares 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 CMSs comments are included starting on page 26. 
OFFICE OF INSPECTOR GENERAL RESPONSE  
We appreciate CMSs 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 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  15  R E C O M M E N D A 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. 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  16    A P P E N D I X   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 -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 patients 
ability to survive a systemic reaction are relative contraindications for 
allergen immunotherapy. Examples include severe asthma 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  17  A P P 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 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  18  A P P 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 
patients vaccine. 
Summary Statement 49. Generally, patients at high risk of systemic 
reaction should receive immunotherapy in the office of the physician 
who prepared the patients vaccine. 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  19  A P P 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 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  20  A P P 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. 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  21    A P P E N D I X   B  
Statistical Confidence Intervals 
Statistic  N  Point Estimate  95% Confidence Interval 
Percentage of immunotherapy-related services that should 
1,434  0.62  0.56 to 0.67 
not have been paid 
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 
1,243  0.34  0.28 to 0.40 
medically necessary 
Percentage of allergy tests that were not medically   
32  0.05  < 0.11 
necessary 
Percentage of ancillary services that were not medically 
127  0.11  0.04 to 0.19 
necessary 
Percentage of services for which immunotherapy was not 
1,434  0.15  0.10 to 0.20 
indicated 
Amount allowed for services where immunotherapy was not 
1,434  $17 million  $12 million to $22 million 
indicated 
Of services for which immunotherapy was not indicated: 
 -the percentage for which allergy tests did not show 
208  0.74  0.56 to 0.91
reactivity 
 -the percentage for which no allergy test was documented  208  0.03  < 0.08 
 -the percentage for which the patients history did not 
208  0.35  0.18 to 0.53 
indicate immunotherapy 
Percentage of services that were allowed for beneficiaries 
1,434  0.24  0.18 to 0.30 
on immunotherapy too long 
Amount allowed for services provided to beneficiaries on 
1,434  $22 million  $17 million to  $28 million 
immunotherapy too long 
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 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  22  A P P 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 
372  0.70  0.65 to 0.75 
standards 
Percentage of beneficiaries whose care met standards  372  0.30  0.25 to 0.35 
Percentage of beneficiaries whose care failed standards in 
372  0.26  0.22 to 0.31 
one area 
Percentage of beneficiaries whose care failed standards in 
372  0.44  0.39 to 0.49 
multiple areas 
Percentage of beneficiaries on shots who had no 
372  0.20  0.16 to 0.24 
demonstrated need for treatment 
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 
372  0.15  0.11 to 0.19 
standards 
Percentage of beneficiaries whose allergy shots were 
372  0.22  0.18 to 0.27 
prepared or delivered inappropriately 
Percentage of beneficiaries who received inadequate      
372  0.44  0.39 to 0.49 
follow-up care 
Percentage of beneficiaries who did not have a patient  
372  0.09  0.06 to 0.12 
history in their record 
Percentage of beneficiaries who had complaints for which 
372  0.03  0.01 to 0.04 
immunotherapy is not appropriate 
Percentage of beneficiaries whose allergy tests did not 
372  0.17  0.14 to 0.21 
indicate a need for treatment 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  23  A P P 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 
74  0.28  0.18 to 0.39 
percentage that also had contraindications 
Percentage of beneficiaries who should have terminated 
372  0.09  0.06 to 0.11 
immunotherapy because it did not benefit them clinically 
Percentage of beneficiaries who were on immunotherapy   
372  0.17  0.13 to 0.20 
too long without justification 
Percentage of beneficiaries on immunotherapy longer than  
372  0.10  0.07 to 0.13 
20 years 
Percentage of beneficiaries who were tested to    
372  0.06  0.03 to 0.08 
inappropriate allergens 
Percentage of beneficiaries who were tested to too many 
372  0.02  0.01 to 0.04 
allergens 
Percentage of beneficiaries who were tested with incorrect 
372  0.10  0.07 to 0.14 
procedures 
Percentage of beneficiaries who were tested with skin 
372  0.06  0.04 to 0.08 
endpoint titration 
Percentage of skin endpoint titrations that were performed  
22  0.27  0.09 to 0.46 
or interpreted incorrectly 
Percentage of beneficiaries whose shots contained 
372  0.08  0.06 to 0.11 
inappropriate allergens 
Percentage of beneficiaries whose shots contained allergens 
372  0.02  0.01 to 0.04 
for which immunotherapy is not indicated 
Percentage of beneficiaries who received shots too   
372  0.11  0.08 to 0.14 
frequently 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  24  A P P 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 
372  0.03  0.01 to 0.04 
undetermined location 
Percentage of beneficiaries whose treatment was not 
372  0.24  0.19 to 0.28 
monitored 
Percentage of beneficiaries who were monitored, but 
312  0.27  0.22 to 0.32 
received inappropriate follow-up 
Percentage of beneficiaries who received inappropriate  
372  0.07  0.05 to 0.10 
repeat skin tests 
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) 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  25    A P P E N D I X   C  

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  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  27    A C K N O W L E D G M E N T S  

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. 
  OEI-09-00-00531  ALLERGEN IMMUNOTHERAPY FOR MEDICARE BENEFICIARIES  28