Immunization: HHS Could Do More to Increase Vaccination Among Older
Adults (Chapter Report, 06/08/95, GAO/PEMD-95-14).

Pneumonia and influenza are the leading causes of vaccine- preventable
death. The elderly suffer the most from these diseases and the costs to
the federal government are substantial.  Annual Medicare hospital
reimbursement can be as high as $1 billion for the treatment of
influenza alone.  Reported use of pneumococcal and influenza vaccines
among the elderly has more than doubled during the past decade, but
immunization rates for both diseases remain low, and mortality is
significant.  Despite the low immunization rates, the Centers for
Disease Control spends very little promoting pneumococcal and influenza
vaccination.  GAO believes that beefing up promotion efforts would boost
immunization rates and save lives. GAO concludes that efforts to improve
health care providers' compliance with adult immunization guidelines are
more promising than are attempts to influence consumers' knowledge and
attitudes. Doctors have a strong impact on patients' vaccination
decisions, but they often fail to recommend vaccination for patients for
whom it is indicated. Computer-based reminder systems, checklists
appended to medical records, practice-based tracking systems, and the
issuance of standing orders for vaccination help to remedy this problem.
The broad-based implementation of a hospital policy to vaccinate
eligible high-risk patients before discharge shows much promise to
reduce vaccine-preventable mortality among adults.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  PEMD-95-14
     TITLE:  Immunization: HHS Could Do More to Increase Vaccination 
             Among Older Adults
      DATE:  06/08/95
   SUBJECT:  Immunization services
             Immunization programs
             Demographic data
             Health statistics
             Infectious diseases
             Elderly persons
             Appropriated funds
             Health surveys
IDENTIFIER:  National Health Interview Survey
             National Influenza Immunization Program
             Medicare Program
             
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Cover
================================================================ COVER


Report to Congressional Requesters

June 1995

IMMUNIZATION - HHS COULD DO MORE
TO INCREASE VACCINATION AMONG
OLDER ADULTS

GAO/PEMD-95-14

Pneumococcal and Influenza Immunization

(973782)


Abbreviations
=============================================================== ABBREV

  ACIP - Advisory Committee on Immunization Practices
  BRFSS - Behavioral Risk Factor Surveillance Survey
  CDC - Centers for Disease Control and Prevention
  HCFA - Health Care Financing Administration
  HHS - Department of Health and Human Services
  HMO - Health maintenance organization
  NCHS - National Center for Health Statistics
  NCID - National Center for Infectious Diseases
  NHIS - National Health Interview Survey
  NIA - National Institute of Aging
  NIP - National Immunization Program
  NVAC - National Vaccine Advisory Committee
  NVPO - National Vaccine Program Office
  ORC - Opinion Research Corporation
  OTA - Office of Technology Assessment
  PHS - Public Health Service
  USIS - United States Immunization Survey
  VA - Department of Veterans' Affairs

Letter
=============================================================== LETTER


B-254782

June 8, 1995

The Honorable John H.  Chafee
Chairman, Subcommittee on Medicaid and
  Health Care for Low-Income Families
Committee on Finance
United States Senate

The Honorable Judd Gregg
Chairman, Subcommittee on Aging
Committee on Labor and Human Resources
United States Senate

Although Medicare covers pneumococcal and influenza vaccination,
rates of immunization among the elderly are low and significant
mortality persists.  At your request, we studied these immunization
rates, the resources the Department of Health and Human Services
(HHS) has expended on monitoring and improving the use of these
vaccines, and the types of interventions that enhance the use of
these vaccines.  We are pleased to present our findings in this
report. 

As discussed with your offices, unless you publicly announce its
contents earlier, we plan no further distribution of this report
until 30 days from its date of issue.  We will then send copies to
the Secretary of Health and Human Services, the Administrator of the
Health Care Financing Administration (HCFA), the Director of the U.S. 
Public Health Service (PHS), the Director of the Centers for Disease
Control and Prevention (CDC), and other interested parties.  We will
also make copies available to others on request. 

If you have any questions or would like additional information,
please call me at (202) 512-3092.  Other major contributors to this
report are listed in appendix VI. 

Kwai-Cheung Chan
Director of Program Evaluation
 in Physical Systems Areas


EXECUTIVE SUMMARY
============================================================ Chapter 0


   PURPOSE
---------------------------------------------------------- Chapter 0:1

Pneumococcal and influenza-associated diseases are the leading causes
of vaccine-preventable death in the United States.  On average,
32,800 people die from pneumococcal disease and 20,000 die from
influenza each year.  The elderly suffer the most from these diseases
and the costs to the federal government are substantial.  Annual
Medicare hospital reimbursement ranges between $500 million and $1
billion for the treatment of influenza-associated illnesses alone. 
At the request of Senators Chafee and Gregg, GAO reviewed
immunization rates among the elderly for flu and pneumococcal
disease, the efforts and resources HHS has devoted to improving these
rates, and the types of interventions that enhance the use of these
vaccines. 


   BACKGROUND
---------------------------------------------------------- Chapter 0:2

The PHS Advisory Committee on Immunization Practices (ACIP) and
professional medical organizations recommend one-time pneumococcal
vaccination and annual flu shots for all persons 65 years or older
and for nonelderly persons in high-risk groups, such as persons with
heart or lung disease.  Safe and effective vaccines are now covered
under Medicare; nonetheless, the 1993 National Health Interview
Survey (NHIS) indicates that immunization rates for these diseases
were below the national goals set by HHS as long ago as 1980. 


   RESULTS IN BRIEF
---------------------------------------------------------- Chapter 0:3

Although reported use of pneumococcal and influenza vaccines among
the elderly has more than doubled in the past 10 years, immunization
rates for both diseases remain low, and morbidity as well as
mortality remain significant.  Pneumococcal disease is associated
with higher mortality than influenza, yet pneumococcal immunization
rates are lower.  Nonetheless, in the 14 years since authorization of
Medicare coverage for pneumococcal vaccination, HHS has conducted few
activities to enhance its use aside from providing Medicare payment. 
Antibiotic resistance of pneumococcal bacteria is increasing, yet
reaching HHS' 60-percent vaccination goal for the year 2000 appears
unlikely based on current trends.  In contrast, in the short time
since Medicare began national coverage for influenza vaccination, HHS
has made significant efforts to enhance the use of this vaccine.  The
pace of increase in influenza vaccination rates since 1989, HHS'
plans to enhance its promotional strategies, and preliminary data
cited by the agency are promising, suggesting that the 60-percent flu
immunization goal for the year 2000 may be attained. 

Although immunization rates are low, CDC spends very little promoting
pneumococcal and influenza vaccination.  GAO believes that increasing
promotion efforts would increase immunization rates and thus save
lives.  But HHS maintains that the appropriations report language
pertaining to CDC strongly discourages the Department from spending
more of its immunization funding on the elderly.  GAO does not agree
that the legislative history dictates CDC's small level of spending
on adult immunization.  GAO reviewed the records of appropriations
hearings and found that HHS has not taken a leadership role in
defining pneumococcal and influenza immunization as important public
health issues for the Congress and in seeking funding commensurate
with their significance. 

To increase vaccination rates, GAO concludes that efforts to improve
health care providers' compliance with adult immunization guidelines
are more promising than attempts to influence consumers' knowledge
and attitudes.  Physicians have a strong impact on consumers'
vaccination decisions, but they often fail to recommend vaccination
to those patients for whom it is indicated.  Computer-based reminder
systems, checklists appended to medical records, practice-based
tracking systems, and issuance of standing orders for vaccination
help to remedy this problem.  The broad-based implementation of a
hospital policy to vaccinate eligible high-risk patients before
discharge shows much promise to reduce vaccine-preventable mortality
among adults. 


   PRINCIPAL FINDINGS
---------------------------------------------------------- Chapter 0:4


      IMMUNIZATION RATES ARE LOW
-------------------------------------------------------- Chapter 0:4.1

HHS currently relies principally on the National Health Interview
Survey to monitor rates of vaccination.  The most recent available
data (from the 1993 NHIS) indicate that 73 percent of older Americans
had never received the pneumococcal vaccination, despite its coverage
under Medicare since 1981, and 49 percent of the elderly had not been
vaccinated against influenza during the 1992-93 flu season preceding
Medicare coverage.\1

Elderly blacks are between one-third and one-half as likely as older
whites to get vaccinated, and persons with high-risk medical
conditions or activity limitations or who describe their health as
poor are generally somewhat more likely to get vaccinated.  Also,
elderly persons who had not visited a doctor in the last year were
less than one-quarter as likely to have gotten either vaccine
compared with those who had three or more doctor visits. 
Nonetheless, even persons with five or more doctor visits were
unlikely to have received pneumococcal vaccination. 


--------------------
\1 In comments on a draft of this report, HHS cites "preliminary"
data from a survey of Medicare beneficiaries indicating 60.8 percent
received a flu shot in the 1993-94 flu season.  This is about 10
percentage points higher than the rate for the previous season, as
estimated by the 1993 NHIS, but consistent with the upward trend in
flu immunization rates since the mid-1980s. 


      HHS' VACCINATION STRATEGIES
      AND RESOURCE ALLOCATIONS ARE
      INADEQUATE
-------------------------------------------------------- Chapter 0:4.2

HHS officials acknowledge and agency documents reflect the
significance of the public health problem presented by both
illnesses.  However, GAO found that HHS has taken few steps to
improve pneumococcal vaccine use since Medicare coverage for the
vaccine was authorized in 1981.  By comparison, HHS has done more in
its recent efforts to improve the use of flu vaccine.  When Medicare
coverage for influenza vaccination began in 1993, HCFA initiated a
public information campaign through the mass media.  In fiscal 1995,
HCFA enhanced this effort by making data on state and county
immunization rates available to health care providers and beginning
limited activities through the agency's peer review organizations. 

Among the HHS agencies we reviewed, HCFA makes the bulk of federal
expenditures directly linked to pneumococcal and influenza
immunization, primarily as Medicare payments (about $100 million in
fiscal 1994).  Although CDC distributed 94 percent of its $528
million fiscal 1994 immunization budget to the National Immunization
Program (NIP), less than 1 percent of these funds were dedicated to
adult immunization activities.  The number of NIP staff positions
dedicated to adult immunization activities remained constant, at
five, between 1987 and 1994, when it increased to seven. 


      PROVIDER-FOCUSED STRATEGIES
      SHOW PROMISE FOR IMPROVING
      IMMUNIZATION
-------------------------------------------------------- Chapter 0:4.3

Strategies that show documented promise for enhancing pneumococcal
and influenza vaccine use include physician reminder systems, the
issuance of standing orders for immunizing patients, and systems for
tracking patients in need of immunization.  Well-designed reminders
to potential vaccinees were also found to be effective.  Although
vaccination clinics and public information campaigns have been part
of successful efforts to improve vaccination rates, the independent
effects of these strategies have not been rigorously evaluated. 

Research suggests that a policy to vaccinate eligible patients before
hospital discharge shows significant promise for reducing
pneumococcal disease.  Studies conducted in the United States,
Canada, and the United Kingdom show that a majority of patients
admitted to hospitals with pneumococcal disease had been discharged
from a hospital within the previous 5 years (and had thus missed an
important vaccination opportunity).  ACIP has recommended that
pneumococcal vaccine be offered routinely to hospitalized patients in
high-risk groups before discharge to prevent future admissions for
pneumococcal disease, but the data suggest that this policy has not
been widely implemented. 


   RECOMMENDATIONS
---------------------------------------------------------- Chapter 0:5

GAO recommends that the Secretary of HHS take a more active
leadership role in promoting pneumococcal and influenza vaccination
among elderly persons by (1) seeking, in the annual appropriations
process, to clarify what proportion of immunization funding should be
allocated for such activities; and (2) directing HCFA and PHS to
focus their efforts on promoting or supporting promising strategies,
such as patient and physician reminder systems, development of
standing order policies, and broad-based use of a hospital policy to
vaccinate eligible patients before discharge. 


   AGENCY COMMENTS
---------------------------------------------------------- Chapter 0:6

Responsible officials from HHS provided written comments on a draft
of this report, which are reproduced in appendix V.  The Department
also provided technical comments, which are addressed in the body of
the report as appropriate. 

The Department generally agreed with GAO that more effort is needed
to increase rates of immunization among the elderly.  Following their
review of our report, HHS officials told us that in fiscal 1997, CDC
plans to propose an initiative in this area.  However, the Department
did not agree with our first recommendation.  HHS stated that the
Congress has previously guided CDC to place priority on childhood
immunization.  However, GAO concluded that one reason why the
Congress has not emphasized a public health role in adult
immunization is because HHS has not taken a leadership role in
promoting its importance. 

With respect to the second recommendation, HHS does not question the
effectiveness or practicality of the strategies GAO identified. 
However, the Department does not specify what steps it will take to
support or encourage use of these strategies, instead emphasizing its
plans to enhance provider and beneficiary awareness of the benefits
of vaccination.  Yet, GAO found that such efforts are not among the
most promising means of increasing immunization rates against these
diseases. 


INTRODUCTION
============================================================ Chapter 1

Medicare covers vaccines against two types of disease that are
hazardous to the health of elderly persons--pneumonia (and other
pneumococcal infections) and influenza.  Although these vaccines are
officially recommended for all persons over 65 and for younger
persons with high-risk conditions, large proportions of those at risk
of morbidity and mortality from these diseases do not receive
inoculations against them.  Consequently, Senators Chafee and Gregg
asked us to assess HHS' efforts to improve these vaccination rates. 
Below, we describe these diseases, the safety and efficacy of the
vaccines, and our approach to assessing HHS' activities to improve
pneumococcal and influenza vaccination rates. 


   BACKGROUND
---------------------------------------------------------- Chapter 1:1


      PNEUMOCOCCAL DISEASE AND
      INFLUENZA
-------------------------------------------------------- Chapter 1:1.1

Pneumonia and influenza are the sixth most common cause of death in
the United States.  Between 15 and 50 percent of all adult pneumonias
are caused by pneumococcal bacteria, and these infections are the
leading cause of pneumonia requiring hospitalization.  In addition to
pneumonia, pneumococcal bacteria can cause serious infections of the
bloodstream (bacteremia) and the covering of the brain or spinal cord
(meningitis). 

Influenza is a highly contagious viral disease that is spread by
direct contact with an infected person or through contact with the
airborne virus.  The public health significance of influenza
vaccination derives from the rapidity with which flu epidemics
evolve, the widespread morbidity associated with these epidemics, and
the seriousness of complications (notably, pneumonias) that may
result from the flu.  Influenza viruses continually change over time;
thus, people are susceptible to influenza infection throughout life. 


         HEALTH CONSEQUENCES
------------------------------------------------------ Chapter 1:1.1.1

Despite antibiotic therapy, pneumococcal disease remains a leading
cause of morbidity and mortality.\1 CDC estimates that there are
268,000 cases of pneumococcal disease per year in the United States
among the approximately 36 million persons 65 years old or older and
that, on average, 32,800 elderly persons die each year from
pneumococcal disease.  People older than 65 are more likely to
contract pneumococcal disease than the general population.  (See
table 1.1.)



                               Table 1.1
                
                   Annual Prevalence of Pneumococcal
                          Disease and Death\a


Disease                                                Cases    Deaths
--------------------------------------------------  --------  --------
Pneumonia                                            250,000    25,000
Bacteremia                                            17,000     7,300
Meningitis                                             1,000       500
Total                                                268,000    32,800
----------------------------------------------------------------------
\a Estimates for persons 65 years of age and older provided by the
Division of Bacterial and Mycotic Diseases, National Center for
Infectious Diseases, CDC, 1994. 

The incidence of influenza varies from year to year depending on the
type of viral outbreak and its level of activity.\2 The highest
illness rate occurs with the A(H3N2) virus, which has caused
epidemics every other year in the last decade.  According to CDC, 5
to 10 percent of the elderly population become ill with influenza
during A(H3N2) outbreaks.  On average, type A and B viruses caused
20,000 deaths per year in the last two decades, with 80 to 90 percent
of deaths occurring among the elderly. 


--------------------
\1 According to case studies by the Office of Technology Assessment
(OTA) published in 1979, early enthusiasm for pneumococcal vaccines
waned with the introduction of antibiotics, which allowed doctors to
treat disease, thereby alleviating dependence on prevention. 
Recently, however, antibiotic resistance of certain types of
pneumococci has accelerated significantly. 

\2 There have been three influenza pandemics this century:  "Spanish
flu" (1918-19), which caused 500,000 deaths in the United States and
20 million deaths worldwide; "Asian flu" (1957-58), which caused
70,000 deaths in the United States; and "Hong Kong flu" (1968-69),
which caused 34,000 deaths in the United States. 


         DISEASE COSTS
------------------------------------------------------ Chapter 1:1.1.2

Precise annual costs for treating pneumococcal disease and influenza
are not available.  However, HCFA researchers have estimated that
Medicare reimburses hospitals $750 million to $1 billion for the
treatment of influenza-associated illness during epidemic periods and
almost a half billion dollars in a nonepidemic year.  The majority of
cases of pneumococcal disease and influenza are treated in outpatient
settings, and these estimates do not include the medical costs
associated with outpatient treatment.  In fiscal 1994, HHS officials
reported expending approximately $100 million on Medicare coverage
for pneumococcal and influenza vaccines and their administration. 


      VACCINE SAFETY AND EFFICACY
-------------------------------------------------------- Chapter 1:1.2


         PNEUMOCOCCAL VACCINE
------------------------------------------------------ Chapter 1:1.2.1

Mild side effects, such as swelling and pain at the injection site,
occur in about half of the people who are given the pneumococcal
vaccine.  However, fever, muscle pain, and more serious local
reactions have been reported in less than 1 percent of recipients. 

The efficacy of pneumococcal vaccine has increased over the years as
new vaccines were introduced to protect against a larger number of
pneumococci (83 types are known).  The current pneumococcal vaccine,
which became available in 1983, protects against 23 types responsible
for approximately 90 percent of the pneumococcal bacteremic
infections found in U.S.  residents. 

Randomized controlled trials have demonstrated that the vaccine
protected against pneumococcal infections in healthy young adults in
settings outside the United States where there were high rates of
pneumococcal disease.  Recently, a large randomized controlled trial
conducted in France found that the vaccine was 77-percent effective
in reducing the incidence of pneumonia in persons living in geriatric
hospitals and homes for the aged. 

In contrast, three major trials with older U.S.  adults--in a prepaid
medical plan in San Francisco, in a chronic disease hospital, and in
a Department of Veterans' Affairs (VA) study--have not demonstrated
pneumococcal vaccine efficacy in preventing pneumococcal pneumonia in
the absence of bacteremia.  However, because the rate of pneumococcal
infection is quite low, it is difficult to demonstrate vaccine
efficacy in a randomized trial.\3

Owing to the difficulties inherent in assessing pneumococcal vaccine
efficacy for older persons from randomized trials, findings from
case-control studies and cohort analyses have become the standard
from which CDC scientists and other experts judge vaccine efficacy. 
Together, these studies indicate an overall protective efficacy
against invasive pneumococcal infection of 60 percent to 70 percent
in elderly persons with normal immune response, regardless of such
high-risk conditions as heart or lung disease. 


--------------------
\3 For example, the frequently cited VA study has received three main
criticisms.  First, critics argue that the randomization process was
flawed because the experimental group was significantly different
from the control group on several important study variables.  Second,
they note that bronchitis (which accounts for almost half of all
pneumococcal infections the study considered as outcome events) was
an inappropriate outcome variable because pneumococcal vaccine is not
generally expected to protect against bronchitis--only pneumonia and
bacteremia are well-accepted outcome measures.  Third, given
infection rates of 60 per 100,000 persons age 65 or older for
bacteremia and between 300 and 600 per 100,000 persons for pneumonia,
very large samples are needed to derive statistically meaningful
conclusions.  Because the size of the sample used in the VA study was
relatively small, the study had only a 6-percent chance to detect a
vaccine efficacy of 65 percent against pneumococcal bacteremia. 


         INFLUENZA VACCINE
------------------------------------------------------ Chapter 1:1.2.2

Although most individuals have no side effects from influenza
vaccines, some may have soreness at the injection site or may
experience fever or body aches for a day or two.  Unlike the 1976
"swine flu" vaccine, recent flu shots have not been linked to
Guillian-Barrï¿½ syndrome.  According to CDC, the vaccines produced
before the mid-1960s were not as purified as today's vaccines, and
they sometimes produced fever, headache, muscle ache, and fatigue. 
These symptoms are similar to those occurring with influenza, thus
some people believed that the vaccine had caused them to get the flu. 
Contrary to myth, it has never been possible to get the flu from
influenza vaccines licensed in the United States because they have
only been made from killed (inactivated) viruses, which cannot cause
infection. 

Influenza vaccine efficacy depends on many factors, including the age
and health status of the recipient and the match between the
prevalent flu strain and the strains addressed in the year's vaccine. 
Studies of healthy young adults have shown influenza vaccine to be
70- to 90-percent effective in preventing illness.  However, in the
elderly, the vaccine is often more effective in reducing the severity
of illness and the risk of serious complications and death than in
preventing illness altogether.  Studies have shown the vaccine to
reduce hospitalization by about 70 percent and death by about 85
percent in noninstitutionalized elderly.  Among nursing home
residents, vaccine can reduce the risk of hospitalization for flu by
about 50 percent, the risk of pneumonia by about 60 percent, and the
risk of death by 75 to 80 percent. 


      VACCINATION RECOMMENDATIONS
-------------------------------------------------------- Chapter 1:1.3

Both pneumococcal and influenza vaccinations are recommended for
elderly persons by U.S.  public health authorities.  Since 1963,
CDC's Advisory Committee on Immunization Practices has recommended
annual vaccination against influenza for persons age 65 and older. 
In 1984, ACIP began recommending a one-time pneumococcal vaccination
for older persons.  In 1989, ACIP also recommended revaccination of
persons at highest risk of fatal pneumococcal infection and those
with rapid loss of pneumococcal antibody levels for whom 6 or more
years had passed since initial vaccination. 

Both vaccinations are also recommended for nonelderly persons with
medical conditions that make them vulnerable to severe complications
from influenza infections or that put them at increased risk of
pneumococcal disease.  Moreover, ACIP, noting research that shows
that two-thirds of persons with serious pneumococcal disease had been
hospitalized in the 5-year period before the illness, recommends that
pneumococcal vaccine be given to hospitalized patients in high-risk
groups before discharge in order to prevent future admissions for
pneumococcal disease. 

Consistent with these professional recommendations, HHS has
established goals for increasing these vaccination rates by the year
2000 to 60 percent of the population defined by ACIP, which includes
all persons age 65 and older, and at least 80 percent of
institutionalized chronically ill or older persons.  The goal of
immunizing 60 percent of the elderly with influenza vaccine is
carried over from a 1990 target set by the Surgeon General in 1980. 


      LEGISLATIVE AUTHORIZATION
      FOR IMMUNIZATION ACTIVITIES
-------------------------------------------------------- Chapter 1:1.4

In July 1981, coverage for pneumococcal vaccine and its
administration became one of the first primary preventive services
added to the Medicare program.  It was incorporated in title XVIII of
the Social Security Act following a 1979 study by the Office of
Technology Assessment that indicated pneumococcal vaccination would
be cost-effective for persons age 65 and over.\4

OTA issued another report, in 1981, that found that influenza
vaccination for persons age 65 and older would be cost-effective.\5
In Public Law 100-203, the Congress mandated that HCFA conduct a
demonstration project regarding Medicare coverage of influenza
vaccination, which subsequently yielded mixed findings on the
cost-effectiveness of flu coverage.\6 According to legislative
mandate, HCFA initiated Medicare coverage for the vaccine and its
administration in May 1993.  Consequently, today Medicare Part B
covers both the cost and the administration of vaccines against
pneumococcal disease and influenza for both elderly and disabled
beneficiaries.  Unlike most other part B services, for which
beneficiaries must pay 20 percent of allowed charges, no copayment is
required for these two services.\7

Providers' claims for delivering these services are processed by a
network of carriers and intermediaries contracted to HCFA, who are
also responsible for educating providers about covered services. 

In addition to HCFA, which administers Medicare, two other HHS units
within the Public Health Service have major legislative authority for
immunization activities:  the National Vaccine Program Office and the
Centers for Disease Control and Prevention.  NVPO was established
within the Office of the Assistant Secretary for Health by the
National Childhood Vaccine Injury Act of 1986 (P.L.  99-660), which
added title XXI to the Public Health Service Act.  The office's
responsibilities extend to coordination of the various federal
agencies involved in immunization activities, including the CDC, and
its prescribed roles include coordinating and directing federal
activities relating to vaccine research, distribution, and use.  As
authorized by section 317 of the Public Health Service Act, CDC
provides immunization assistance in the form of grants to states and
other public entities and conducts research activities. 


--------------------
\4 OTA.  A Review of Selected Federal Vaccine and Immunization
Policies:  Based on Case Studies of Pneumococcal Vaccine. 
Washington, D.C.:  Sept.  1979. 

\5 OTA.  Cost-Effectiveness of Influenza Vaccination.  Washington,
D.C.:  Dec.  1981. 

\6 Abt Associates, Inc.  Medicare Influenza Vaccine Cost-Savings
Study:  Evaluation Report.  Cambridge, Mass.:  Mar.  22, 1993. 

\7 Providers who do not accept assignment may bill beneficiaries for
15 percent more than the Medicare allowance. 


   SCOPE AND METHODOLOGY
---------------------------------------------------------- Chapter 1:2


      SCOPE
-------------------------------------------------------- Chapter 1:2.1

We limited our review of HHS' immunization strategies to pneumococcal
and influenza vaccination because both are covered under Medicare,
both are recommended for all persons 65 years of age or older, and
both cause significant morbidity and mortality among elderly persons. 

Federal responsibilities and activities related to utilization of
pneumococcal and influenza vaccines among the elderly are spread
across a number of departments, agencies, and offices.  We focused
our review principally on three HHS units: 

  -- the Health Care Financing Administration, which administers the
     Medicare program;

  -- the National Vaccine Program Office within the PHS' Office of
     the Assistant Secretary for Health, which has been charged with
     coordinating the immunization activities of many federal
     agencies, offices, and departments to achieve optimal prevention
     of infectious diseases through immunization; and

  -- the CDC's National Immunization Program, which conducts research
     and provides grants and other assistance for state and local
     immunization activities. 


      METHODOLOGY
-------------------------------------------------------- Chapter 1:2.2

To assess the methods and resources HHS uses to monitor and improve
levels of immunization among Medicare beneficiaries, we conducted
interviews with officials at NIP, NVPO, and relevant HCFA offices. 
We also attended meetings of the NVPO's National Vaccine Advisory
Committee and examined relevant promotional materials, reports,
budgets, and enabling legislation. 

We examined HHS' analyses of characteristics of immunized and
nonimmunized elderly persons, including published and unpublished
papers, technical documents, conference presentations, and
statistical results from computer runs.  To determine why
pneumococcal and influenza immunization levels are low, we reviewed
literature and consulted immunization experts.  We used standard
statistical and scientific principles to evaluate HHS' methods and to
assess the strength of evidence supporting various interventions. 

We conducted our review in accordance with generally accepted
government auditing standards.  We did not independently verify or
statistically process the data CDC provided to us. 


METHODS AND RESULTS OF MONITORING
IMMUNIZATION RATES
============================================================ Chapter 2


   METHODS OF MONITORING
   IMMUNIZATION RATES
---------------------------------------------------------- Chapter 2:1

HHS has relied principally on household surveys to estimate national
rates of pneumococcal and influenza immunization among
noninstitutionalized adults.  Other information bearing on
pneumococcal and influenza vaccine use is available from CDC's
collection of manufacturers' quarterly reports of doses distributed
and from records of vaccination claims submitted to HCFA for Medicare
reimbursement.\1


--------------------
\1 Since completion of our review, HCFA has gathered information on
Medicare beneficiaries' receipt of influenza immunization during the
1993-94 flu season through its 1994 Current Beneficiary Survey. 
However, these data were described as "preliminary" on Mar.  27,
1995, when the agency provided comments on our draft report.  We did
not review these data and the precision of estimates produced by the
survey.  Agency officials told us that preliminary findings indicated
that the flu immunization rate for Medicare beneficiaries has topped
60 percent, but that the pneumococcal immunization rate remains at 28
percent. 


      PAST AND PRESENT SURVEY
      METHODS
-------------------------------------------------------- Chapter 2:1.1

As shown in table 2.1, since 1964, HHS has used a sequence of three
different surveys to monitor pneumococcal and influenza immunization
rates at various intervals:  a supplement to the Current Population
Survey known as the United States Immunization Survey (USIS), the
Behavioral Risk Factor Surveillance Survey (BRFSS), and supplements
to the National Health Interview Survey.  The NHIS data come from
respondents' reports of their own and family members' immunization
status when asked, "During the past 12 months--that is, since (date)
a year ago--have any adults in the family received a flu shot?" and
"Have any adults in the family ever received a pneumonia vaccine?"



                               Table 2.1
                
                     Surveys Used to Monitor Adult
                           Immunization Rates


            Influenz  Pneumococc
Survey      a         us          Sampling frame
----------  --------  ----------  ------------------------------------
USIS        1964      1985        Civilian, noninstitutionalized U.S.
            1969-85               population

BRFSS       1987      1993        31 states and D.C. in 1987 and 49
            1993                  states in 1993

NHIS        1989      1989        Civilian, noninstitutionalized U.S.
            1991      1991        population
            1993      1993
----------------------------------------------------------------------
Source:  CDC/NIP, 1993. 


      SURVEY LIMITATIONS
-------------------------------------------------------- Chapter 2:1.2

The survey data from the NHIS are currently the best available
national information on pneumococcal and influenza immunization
rates.  However, we did identify some limitations of HHS' current
survey methodology.  For reasons of economy and efficiency,
information on different medical conditions is collected from
different subsets of the NHIS sample.  Data on the two major
high-risk conditions for pneumococcal and influenza disease--heart
and lung disease--are collected from separate subsamples, each
comprised of one-sixth of the total sample.  This design limits the
factors that may be included in analyses to improve understanding of
the root causes of underimmunization among elderly persons with
high-risk conditions or multiple risk factors.  We raised this issue
in a meeting with HHS officials in August 1994 and were told that the
1995 NHIS would be modified to address this problem. 

A second potential limitation of HHS' method of monitoring
immunization rates concerns the lack of information on the accuracy
with which respondents report their own or household members'
vaccination status.\2 Insofar as trends in NHIS data are generally
consistent with trends in other indicators of vaccine use (discussed
below), we do not view this as a serious problem for current
applications.  However, the extent of downward or upward bias in
self-reported rates might be assessed by examining self-reports for a
sample of individuals whose immunization status is known through
other means. 

Finally, HHS lacks recent data on the immunization status of the
institutionalized elderly, such as nursing home residents, who are an
important segment of the 85 and older age group and who are also at
high risk of complications from pneumococcal and influenza disease. 
Such data could be useful, not only in monitoring immunization
objectives, but also in assessing the quality of care offered by
particular facilities.  In response to our draft report, Department
officials noted that the National Center for Health Statistics will
begin to collect data on influenza and pneumococcal vaccination from
a sample of nursing homes in 1995 and every other year thereafter. 


--------------------
\2 NIP and National Center for Health Statistics (NCHS) researchers
have also noted the lack of studies assessing the accuracy of
self-reported immunization status for pneumococcal and influenza
disease.  See Desiree Rodgers et al., Division of Immunization, CDC
and NCHS, "Influenza and Pneumococcal Vaccination in the Elderly: 
Results of the 1989 National Health Interview Survey," presentation
made to the 1991 annual meeting of the American Public Health
Association and to the 1992 CDC Epidemic Intelligence Service
Conference. 


      SUPPLEMENTAL DATA
-------------------------------------------------------- Chapter 2:1.3

HHS maintains two data systems that can be used to supplement its
survey-based estimates of immunization rates.  CDC's vaccine
surveillance system, based on manufacturers' quarterly reports of
vaccine distributed and returned, provides a rough indicator of
national vaccine use.  In addition, HCFA's National Claims History
File contains information on Medicare reimbursement for pneumococcal
and influenza vaccinations.  Although these claims data are not
susceptible to the limitations of self-reported survey data, they
suffer from other limitations that restrict their utility for
calculating immunization rates.\3


--------------------
\3 Medicare claims data are incomplete for the following reasons: 
(1) about 5 percent of the elderly are not enrolled in Medicare, (2)
as of 1991, approximately 7 percent of Medicare beneficiaries were
enrolled in prepayment plans (such as HMOs), and HCFA does not have
records on the services utilized by enrollees of these plans, and (3)
the data for each calendar year are collected from claims processed
through March 31 of the following year, and HCFA estimates that up to
8 percent of potential claims are processed after March 31. 
Reflecting these gaps, HCFA has estimated that 10-20 percent of
Medicare beneficiaries got flu shots in 1993 that were not reimbursed
by HCFA (i.e., for which no Medicare claim was submitted). 


   IMMUNIZATION RATES:  TRENDS AND
   CORRELATES
---------------------------------------------------------- Chapter 2:2


      TRENDS IN VACCINE USE
-------------------------------------------------------- Chapter 2:2.1

The three national surveys HHS has used to monitor changes in
immunization rates--USIS, BRFSS, and NHIS--are the sources of data
used in figures 2.1 and 2.2 to portray trends in pneumococcal and
influenza vaccine use.\4

   Figure 2.1:  Influenza
   Vaccination Rates for Persons
   Age 65 and Older\a

   (See figure in printed
   edition.)

\a Immunization rates were not estimated in 1986, 1988, 1990, and
1992.  As shown, the year 2000 goal for noninstitutionalized elderly
is 60 percent. 

Taken together, these data suggest that annual use of influenza
vaccine and cumulative use of pneumococcal vaccine more than doubled
in the decade preceding 1993.  Annual influenza vaccine use among the
elderly has increased from about 20 percent in 1964 (not shown in
figure 2.1) to about 51 percent in 1993.  After a period of relative
stability throughout most of the 1980s, influenza vaccine use
increased approximately 10 percentage points from 1989 to 1991 and 10
more percentage points from 1991 to 1993.  Cumulative pneumococcal
vaccine use was about 11 percent in 1985 and had grown to about 27
percent in 1993. 

   Figure 2.2:  Cumulative
   Pneumococcal Vaccination Rates
   for Persons Age 65 and Older\a

   (See figure in printed
   edition.)

\a Pneumococcal vaccine became a Medicare-covered benefit in July
1981.  The pneumococcal immunization rate was not estimated in
1981-84, 1986-88, 1990, and 1992.  As shown, the year 2000 goal for
noninstitutionalized elderly is 60 percent. 


--------------------
\4 Because BRFSS data are not strictly generalizable to the U.S. 
population, the immunization rates for 1987 are not strictly
comparable to those for earlier and later years.  The 1993 data in
figures 2.1 and 2.2 represent findings from the NHIS, which were in
close agreement with those from the 1993 BRFSS. 


      VACCINE USE AMONG ELDERLY
      PERSONS WITH HIGH-RISK
      CONDITIONS
-------------------------------------------------------- Chapter 2:2.2

For all years before and including 1985 (except 1976, the year the
swine flu epidemic was expected), the rate of influenza immunization
among the high-risk elderly remained below 30 percent.  By 1991, this
rate had increased to 46 percent for persons with cardiovascular
disease and 52 percent for persons with pulmonary disease.  In 1991,
the cumulative pneumococcal immunization rate was 21 percent for
persons with cardiovascular disease and 32 percent for persons with
pulmonary disease.  (CDC analyses of 1993 NHIS data had not been
completed at the time this report was prepared.)


      CHARACTERISTICS OF IMMUNIZED
      AND NONIMMUNIZED PERSONS
-------------------------------------------------------- Chapter 2:2.3

We identified three analyses of the characteristics of immunized and
nonimmunized persons:  (1) CDC's study of trends in influenza vaccine
coverage using USIS data collected from 1969 to 1985, (2) an
investigation of the utilization of pneumococcal vaccine among
elderly Medicare beneficiaries from 1985 to 1988, and (3) CDC's
analysis of pneumococcal and influenza immunization status using 1989
and 1991 NHIS data.\5 We concentrated our discussion on CDC's
analyses of 1989 and 1991 NHIS data because they provided the most
current and methodologically rigorous investigation of elderly
persons' pneumococcal and influenza vaccine use that was available
during our review. 

CDC staff examined immunization rates among persons with various
demographic characteristics, health status indicators, and measures
of health behavior.  (See table 2.2.) They found that, in 1991,
pneumococcal and influenza immunization rates for all subgroups in
the elderly population were well below HHS' goal of 60-percent
immunization among noninstitutionalized elderly persons. 



                               Table 2.2
                
                 1991 Immunization Rates by Demographic
                     and Health Characteristics of
                              Vaccinees\a


                                                Pneumococc
Variable                                                al   Influenza
----------------------------------------------  ----------  ----------
Demographic characteristic
Gender
Male                                                 19.9%       41.2%
Female                                                20.0        40.7

Race
----------------------------------------------------------------------
Black                                                 13.4        26.5
White                                                 20.6        42.4
Asian                                                 14.3        28.4
Other                                                 19.9        36.8

Poverty status
----------------------------------------------------------------------
Below poverty index                                   15.8        35.5
Above poverty index                                   21.0        42.1

Education
----------------------------------------------------------------------
Less than high school                                 17.2        36.0
High school or more                                   21.8        44.2

Region
----------------------------------------------------------------------
Northeast                                             16.8        36.5
South                                                 19.4        40.6
Midwest                                               20.0        42.7
West                                                  24.6        44.4

Residential setting
----------------------------------------------------------------------
Urban                                                 21.2        40.3
Suburban                                              21.5        41.0
Rural                                                 20.8        44.3

Health status
----------------------------------------------------------------------

Self-reported health assessment
----------------------------------------------------------------------
Fair or poor                                          23.0        42.8
Very good or good                                     19.9        42.4
Excellent                                             15.0        32.6

High-risk condition
----------------------------------------------------------------------
Cardiovascular                                        21.0        46.0
Pulmonary                                             32.0        52.0

Activity limitations
----------------------------------------------------------------------
Some                                                  24.2        44.4
None                                                  17.4        38.9

Health behavior
----------------------------------------------------------------------

Doctor visits in past year
----------------------------------------------------------------------
Zero                                                   8.3        17.1
One                                                   16.5        35.1
Two to four                                           20.7        43.5
Five or more                                          25.4        50.1
----------------------------------------------------------------------
\a For U.S.  noninstitutionalized population age 65 years and older. 
Immunization rates for those under 65 years are 5.4 percent
(pneumococcal) and 7.9 percent (influenza). 

Source:  1991 NHIS Immunization Supplement and CDC analyses. 

At the time of our review, CDC staff had completed multivariate
analyses using 1989 NHIS data only.  They developed two logistic
regression models, one predicting pneumococcal vaccine use and the
other predicting influenza vaccine use.  Of all the variables listed
in table 2.2, those that were significantly related to vaccination
status were included in the regression models (only region and
residential setting were thus excluded.)\6 Results from these
analyses are summarized below.  All findings pertain only to the U.S. 
population of noninstitutionalized persons 65 years old or older, and
all relationships are adjusted for other variables in the model. 
(See table 2.3.)



                               Table 2.3
                
                     Logistic Regression Predicting
                 Pneumococcal and Influenza Vaccination
                    Among Persons Age 65 and Older\a


                                Variable          Pneumococc  Influenz
Variable        Referent group  category          us          a
--------------  --------------  ----------------  ----------  --------
Race            Black           White             2.67        2.06

Education       Less than high  More than high    Not         1.36
                school          school            significan
                                                  t

Health status   Excellent       Poor              1.77        1.36

                                                              Not
Cardiovascular  None            Some              1.6         signific
condition                                                     ant

Pulmonary
condition       None            Some              2.5         1.9

Activity
limitations     None            Some              Not         1.23
                                                  significan
                                                  t

Doctor visits   None            Three or more     4.14        4.35
----------------------------------------------------------------------
\a Using 1989 NHIS data. 

Source:  CDC/NIP, 1994. 


--------------------
\5 (1) Information supplied by CDC/NIP; (2) A.  Marshall McBean, J. 
Daniel Babish, and Ronald Prihoda, "The Utilization of Pneumococcal
Polysaccharide Vaccine Among Elderly Medicare Beneficiaries, 1985
Through 1988," Archives of Internal Medicine, 151 (Oct. 
1991):2009-16; and (3) Desiree Rodgers et al., Division of
Immunization, CDC and NCHS, "Results of the 1989 National Health
Interview Survey" and K.S.  Heath et al., "Influenza and Pneumococcal
Vaccination Among Older Adults:  Results of the 1991 National Health
Interview Survey [Abstract]," in Program and Abstracts of the CDC
Epidemic Intelligence Service 43rd Annual Conference (Atlanta:  CDC,
1994), p.  33. 

\6 In contrast, CDC's earlier analyses of USIS data indicated that
from 1973 to 1985, among all adults, rural dwellers had higher
influenza vaccination coverage than their urban counterparts. 
However, the possible reasons for this apparent difference are
unclear because age, race, income, education, and use of medical care
are not included in the analyses. 


         DEMOGRAPHIC
         CHARACTERISTICS
------------------------------------------------------ Chapter 2:2.3.1

Even controlling for education, income, health status, and use of
medical care, elderly persons who were white had almost three times
the odds of receiving pneumococcal vaccine and twice the odds of
receiving influenza vaccine as elderly persons who were black. 
Although having attained at least a high school education was not
significantly related to receiving pneumococcal vaccine, it was
associated with slightly higher odds of receiving influenza vaccine. 
CDC found that when all other variables were controlled, poverty and
gender were not related to vaccination status, so they were
consequently dropped from the model reported in table 2.3.  These
analyses did not address differences in immunization rates among
various elderly age groups.\7


--------------------
\7 In the previously cited study of pneumococcal vaccine use based on
claims among Medicare beneficiaries between 1985 and 1988, findings
indicated that persons 85 and older and those between 65 and 69 are
somewhat less likely to get vaccinated than the remainder of elderly
persons. 


         HEALTH STATUS
------------------------------------------------------ Chapter 2:2.3.2

In general, lower health status is related to higher odds of being
vaccinated.  Elderly people who reported their overall health as poor
had about 1.8 times the odds of receiving pneumococcal vaccine and
about 1.4 times the odds of receiving influenza vaccine as those who
described their health as excellent.  Elderly persons with a
pulmonary condition had 2.5 times the odds, and those with a
cardiovascular condition had 1.6 times the odds of receiving
pneumococcal vaccine, as compared to those without these high-risk
conditions.  Similarly, those with a pulmonary condition had almost
twice the odds, and those with activity limitations had 1.2 times the
odds of receiving influenza vaccine, as compared to those without
lung disease or activity limitations, respectively. 

However, we note that CDC also found that older people with
cardiovascular disease (the leading cause of death in the United
States) were not significantly more likely to receive influenza
vaccine than persons without cardiovascular disease.  This finding is
important because elderly persons with such conditions are at greater
risk of dying from pneumococcal disease and influenza. 


         PHYSICIAN CONTACTS AND
         HEALTH BEHAVIOR
------------------------------------------------------ Chapter 2:2.3.3

The frequency of seeing a doctor is by far the best predictor of
pneumococcal and influenza vaccination status.  Compared to elderly
persons who had not seen a doctor during the previous year, those
with three or more doctor visits had at least four times the odds of
getting vaccinated.  Nonetheless, even among persons with five or
more doctor visits in the past year, half reported no influenza
vaccination and three quarters reported no pneumococcal
vaccination.\8

In a published report of multivariate analyses of 1987 BRFSS data,
CDC also found that such health risk-taking behaviors as smoking,
obesity, lack of seat-belt use, and sedentary lifestyle are related
to decreased likelihood of influenza vaccine use.\9


--------------------
\8 In chap.  4, we discuss the significance of recommendations by
physicians, and in chap.  5, we discuss hospital-based immunization
strategies. 

\9 Paul A.  Stehr-Green et al., "Predictors of Vaccination Behavior
Among Persons Ages 65 Years and Older," American Journal of Public
Health, 80:9 (Sept.  1990), 1127-29. 


   SUMMARY
---------------------------------------------------------- Chapter 2:3

HHS relies principally on the National Health Interview Survey for
tracking trends in immunization rates.  This strategy has some
disadvantages, but currently provides the best available information
on pneumococcal and influenza immunization rates.  Importantly, more
than a decade after Congress made pneumococcal vaccination almost
universally available to elderly persons through Medicare coverage,
survey data indicate that about 73 percent of older Americans have
not received this one-time-only vaccination.  Moreover, in the 1993
flu season, just before Medicare began coverage of flu shots, 49
percent of elderly Americans had not been vaccinated against
influenza.  HHS officials report that preliminary data from a survey
of beneficiaries conducted for the 1993-94 flu season found a higher
rate of flu vaccine use (60.8 percent), but roughly the same low
level of use for pneumococcal vaccine (28 percent).\10

Among elderly persons with high-risk conditions, immunization rates
tend to be higher, but they are still below HHS goals set as long ago
as 1980.  In 1991, surveys indicated 21 percent of persons with heart
disease and 32 percent of those with lung disease had received
pneumococcal vaccination, while 46 percent of persons with heart
disease and 52 percent of those with lung disease had received
influenza vaccination. 

According to CDC's analyses of 1989 NHIS data, although all major
subgroups of the U.S.  elderly population are undervaccinated, some
are less likely to get vaccinated than others.  Two such cases stand
out.  First, elderly persons who are black are two to nearly three
times less likely to receive pneumococcal and influenza vaccines than
elderly persons who are white, even after adjusting for other
factors.  Second, elderly people with no doctor visits in the
previous year are over four times less likely to receive these
vaccinations than those who have visited a physician three or more
times.  Even so, 75 percent of elderly persons with five or more
physician visits report failing to receive pneumococcal vaccination. 

Persons who reported poor health status or lung conditions were more
likely than persons without these conditions to be immunized for flu
or pneumococcal disease.  However, CDC's analyses show that elderly
persons with a cardiovascular condition are no more likely to receive
influenza vaccine than those without a cardiovascular condition. 


--------------------
\10 We did not independently examine the methodology of this survey,
the response rate, or the precision of the estimate.  It is not
strictly comparable to earlier surveys, which used a broader sampling
frame and different methods for obtaining data. 


AGENCY IMMUNIZATION STRATEGIES
============================================================ Chapter 3

In this chapter, we describe HHS activities undertaken to increase
pneumococcal and influenza immunization in the respective periods
since these vaccines became Medicare benefits.  We also provide
information on the resources that major departmental units have
applied to improving these immunization rates. 


   ACTIVITIES TO IMPROVE
   IMMUNIZATION RATES
---------------------------------------------------------- Chapter 3:1


      HEALTH CARE FINANCING
      ADMINISTRATION
-------------------------------------------------------- Chapter 3:1.1

Since pneumococcal vaccination became a Medicare-covered service over
13 years ago, HCFA has made only a few attempts to encourage the use
of this vaccine among the elderly.  HCFA announced the availability
of the pneumococcal vaccine benefit in Medicare carrier and
intermediary manuals, but did not require carriers and intermediaries
to inform providers of the new benefit.  To inform beneficiaries of
the new benefit, HCFA has included brief statements in Medicare
handbooks, Social Security check inserts sent to beneficiaries in
January 1982, and flu vaccine promotional flyers produced and
distributed during its fiscal year 1994 campaign. 

HCFA's promotion of influenza vaccination since it became a
Medicare-covered benefit in 1993 consists of four major activities: 
(1) requiring that carriers and intermediaries notify physicians,
providers, and suppliers of Medicare coverage of the influenza
vaccine and its administration; (2) simplifying certain billing
procedures; (3) conducting a public information effort in fiscal year
1994 known as the Medicare Flu Shot Campaign; and (4) implementing a
targeted public information effort and supplementary activities known
collectively as the Consumer Information Strategy in fiscal year
1995.  Each of these activities is explained more fully below. 

In July 1993, HCFA instructed its carriers and intermediaries to
notify physicians, providers, and suppliers of the new influenza
vaccine benefit.  HCFA did not specifically evaluate compliance with
this routine request; however, judging from the activities of a
nonrepresentative sample of 11 carriers and intermediaries summarized
by HCFA, the form of this notification effort varied widely.\1

To remove inconveniences to providers claiming reimbursement for
immunization services, HCFA began to allow those public health
centers that do not use electronic billing systems to submit a
"roster" of vaccinees rather than bill for each beneficiary
separately.  HCFA also permitted providers or suppliers to bill
separately for vaccine or vaccine administration, rather than require
that both claims be submitted together.  This policy change responds
to situations in which providers receive free vaccine (from states or
organizations) and need to bill only for its administration. 

HCFA's Office of Public Affairs coordinated the HHS fiscal year 1994
Medicare Flu Shot Campaign with staff from PHS and the Administration
on Aging.  A number of activities were conducted as part of this
campaign, including a press conference by the Secretary;
incorporation of brief announcements in Medicare claims forms sent to
beneficiaries who had had claims (see appendix III); and distribution
of public service announcements, video and audio news releases, op-ed
pieces, flyers, and supermarket displays.  According to information
provided by HCFA's Office of Public Affairs, by December 1993, 8
percent of the nation's newspaper and radio stations and 28 percent
of television stations had aired HHS flu benefit information. 

The fiscal 1995 Medicare Flu Shot Campaign--which HCFA describes as
the first initiative in its new Consumer Information Strategy--built
on the public information strategy of the fiscal 1994 campaign.  Data
dissemination, another component of the 1995 strategy, entails making
available to consumers and providers claim-based calculations of
states' and counties' flu immunization rates tabulated by age,
gender, and race.  Finally, a local intervention component of the
1995 strategy consists of peer review organizations' and carriers'
collaboration with local health care organizations in seven
geographic areas to increase immunization rates in their parts of the
country.  The agency also reported it was considering increasing the
vaccine administration fee ($3.71, regionally then adjusted) and
simplifying billing procedures for institutions. 


--------------------
\1 Some carriers and intermediaries announced the flu benefit in
provider bulletins, some sent letters to public health centers, and
some also sponsored clinics or seminars, usually at health fairs or
conferences, at which they distributed information on influenza
immunization to providers or beneficiaries.  The number of persons
contacted was typically in the hundreds.  At the extreme, one carrier
reported that it mailed 275,000 flyers to seniors in Florida. 


      NATIONAL VACCINE PROGRAM
      OFFICE
-------------------------------------------------------- Chapter 3:1.2

In its role as coordinator of immunization activities across the
federal government, NVPO has developed the National Vaccine Plan,
which defines the PHS strategic framework for fiscal years 1994 and
1995.  The major goals cited in this document include better
educating the public and members of the health professions on the
benefits and risks of immunization and achieving better use of
existing vaccines to prevent disease, disability, and death.  The
Plan observes that vaccination coverage in adults over 65 years of
age is low, cites estimates of the cost of vaccine-preventable
diseases exceeding $10 billion each year, and acknowledges that over
27,400 deaths per year are preventable through increased use of
influenza and pneumococcal vaccines.\2

However, even though the National Vaccine Plan adopts the objective
of increasing "immunization coverage levels among older adolescents,
adults, and the elderly," efforts to improve childhood immunization
constitute its top priority. 

The fiscal 1994-95 National Vaccine Plan states that the "NVPO with
other agencies will identify steps that federal agencies can take to
implement the National Advisory Committee report on 'Adult
Immunization.'"\3 However, the plan does not state what level of
priority or resources might be accorded such steps. 


--------------------
\2 Pierce Gardner and William Schaffner, "Immunization of Adults,"
New England Journal of Medicine, 328:17 (Apr.  29, 1993), 1252-58. 

\3 (1) NVPO, Disease Prevention Through Vaccine Development and
Immunization:  The National Vaccine Plan (Washington, D.C.:  PHS
1994), p.  vii; and (2) National Vaccine Advisory Committee, Adult
Immunization (Washington, D.C.:  PHS, Jan.  1994). 


      CENTERS FOR DISEASE CONTROL
      AND PREVENTION
-------------------------------------------------------- Chapter 3:1.3

CDC's activities for increasing the use of flu and pneumococcal
vaccines are concentrated in the National Immunization Program, which
in 1994 dedicated 5 of its 289 full-time staff to the agency's Adult
Immunization Initiative.\4

Since late 1994, the number of NIP staff working directly on adult
immunization issues has increased to seven.  These staff have
provided information and educational materials to professional and
lay groups by publishing articles on pneumococcal and influenza
immunization in professional journals and participating in
CDC-supported forums, conferences, and presentations on related
immunization topics.  In addition to these general informational
activities, CDC has printed and distributed an adult immunization
pamphlet, a promotional kit, and a guidebook on managing influenza
vaccination programs in nursing homes.  CDC has also collaborated
with HCFA on major research and demonstration projects related to
pneumococcal and influenza vaccination, such as the Hawaii
Pneumococcal Disease Initiative (Feb.  1988-Feb.  1989) and the
Medicare Influenza Demonstration (fiscal years 1989-92).  Finally,
the agency is responsible for vaccination recommendations,
guidelines, and standards for immunization. 

CDC has not used its grant support of state and metropolitan
immunization projects to mount a broad effort to increase
pneumococcal and influenza immunization rates, citing the emphasis on
childhood immunization responsibilities in fiscal 1990-95 legislative
documents.  CDC and NVPO officials indicated that expenditure of
further resources on activities to improve pneumococcal and influenza
immunization rates would have been inconsistent with congressional
guidance. 


--------------------
\4 Epidemiologic and laboratory research on pneumonia and influenza
is conducted at CDC's National Center for Infectious Diseases. 
According to officials there, staff from the viral and bacterial
branches dedicate the equivalent of about one full-time staff per
year to answer telephone calls about pneumonia and influenza from the
public, health care providers, and the media.  NCID's Influenza
Branch of the Division of Viral and Rickettsial Diseases monitors
influenza strains and conducts research on vaccine development,
evolution of flu strains, and viral resistance to amantadine (an oral
drug that reduces influenza A symptoms).  The Division of Bacterial
and Mycotic Diseases investigates the epidemiology of pneumococcal
disease and conducts research on pneumococcal vaccine efficacy,
diagnostic tests for pneumococcal disease, and antibiotic resistance
of pneumococci. 


      NATIONAL INSTITUTE ON AGING
-------------------------------------------------------- Chapter 3:1.4

In 1993, NIA initiated a provider-focused informational campaign to
encourage pneumococcal vaccine use.  NIA consulted infectious disease
experts, conducted a literature review, and ran focus groups with
physicians and elderly persons to identify barriers to higher
immunization rates.  Subsequently, NIA held a conference with members
of health care specialty groups and, in spring 1994, mailed 120,000
informational kits to members of six medical associations. 


      OFFICE OF DISEASE PREVENTION
      AND HEALTH PROMOTION
-------------------------------------------------------- Chapter 3:1.5

In early fall 1994, PHS' Office of Disease Prevention and Health
Promotion launched a national effort to improve the delivery of
preventive services in primary care settings.  This initiative,
called "Put Prevention Into Practice," makes materials available for
sale to providers, patients, and professional organizations that are
based on tested interventions.  They include aids in flagging the
charts of patients for whom various preventive interventions are
indicated and forms for improving provider and patient records of
preventive services.\5 Pneumococcal and influenza vaccination feature
prominently in these materials, and assuming they are widely used,
they appear promising for improving vaccination levels. 


--------------------
\5 HHS/PHS, "Put Prevention Into Practice" Education and Action Kit,
GPO Stock Number 017-001-00492-8 (Pittsburgh:  Government Printing
Office, 1994). 


   RESOURCES
---------------------------------------------------------- Chapter 3:2


      HEALTH CARE FINANCING
      ADMINISTRATION
-------------------------------------------------------- Chapter 3:2.1

Medicare expenditures for fiscal year 1994 included about $100
million for influenza and pneumococcal vaccine and vaccine
administration.  HCFA spent about $95,000 conducting the fiscal 1994
Medicare Flu Campaign. 


      NATIONAL VACCINE PROGRAM
      OFFICE
-------------------------------------------------------- Chapter 3:2.2

National Vaccine Program funding began in fiscal year 1988.  In
fiscal years 1992 and earlier, the budget included both discretionary
and NVPO operation expense funds, and during this time, the vast
majority of program funds were dedicated to discretionary spending.\6
These discretionary funds were distributed to three PHS agencies
(CDC, Food and Drug Administration, and National Institutes of
Health) for emerging high-priority vaccine projects.\7 In fiscal year
1993, the total National Vaccine Program budget declined sharply; the
operating budget was actually higher than in previous years, but none
of the discretionary spending in fiscal years 1993 and 1994 was
administered by NVPO.  Under fiscal year 1995 appropriations,
staffing and resource allocations for the NVPO have been
substantially reduced. 


--------------------
\6 The highest priority for these funds was to accelerate the
development of a new whooping cough vaccine.  Other high-priority
areas for discretionary spending were measles vaccine, vaccine safety
and adverse events, the Children's Vaccine Initiative, the
Sexually-Transmitted Disease Initiative, and research on development
of a new influenza vaccine. 

\7 These discretionary funds are also described as seed money "to
nurture promising vaccine initiatives and encourage the development
of new and innovative ideas to improve vaccine development and
delivery."


      CENTERS FOR DISEASE CONTROL
      AND PREVENTION
-------------------------------------------------------- Chapter 3:2.3

According to the Director of the National Immunization Program at
CDC, adult immunization is a "top, but unfunded, priority." In making
this statement, the Director relies on language in the House
Appropriations Committee report on the PHS appropriation for fiscal
1994.  In the report, the Committee emphasizes childhood
immunization.  However, we found that the law permits CDC to increase
its spending on pneumococcal and influenza immunization activities,
and these activities are, of course, consistent with its public
health mission.  But CDC believes that an increase in resources for
these activities would be inconsistent with the priority the
Committee has given to childhood immunization. 

CDC's congressional appropriations for immunization activities
increased more than sixfold between fiscal years 1987 and 1994, with
a 55-percent increase in 1994 over the previous year.  CDC
distributed 94 percent of its $528 million fiscal year 1994
immunization budget to NIP, but less than 1 percent (less than $1
million) was dedicated to adult immunization activities. 

The majority of CDC's immunization funds--$423 million in fiscal year
1994--are distributed to public health agencies throughout the
country in Immunization Program Grants.  Although the promotion of
adult immunization is one of the grant program's eight goals and CDC
recommends these activities, they have not been among the 26
requirements that potential grantees must meet. 

Like its budget, CDC's staff positions for immunization activities
have also increased substantially, having more than doubled (from 125
to 289 full-time equivalents) between 1987 and 1994.  However, the
number of staff positions dedicated to adult immunization
activities--five--remained constant during this period, increasing to
seven in late 1994. 


   SUMMARY
---------------------------------------------------------- Chapter 3:3

In the 1993-94 flu season, HHS conducted varied activities to
increase flu immunization rates and inform Medicare beneficiaries of
the new coverage for flu immunization.  Specifically, HHS published
research articles, conducted public information campaigns,
distributed informational kits and pamphlets, held immunization
conferences, and asked Medicare carriers and intermediaries to inform
providers of the new flu benefit.  In the present flu season, HCFA
has augmented these strategies with the dissemination of data on
state and county flu immunization rates, and PHS has developed
materials to assist providers and consumers in recording and
implementing preventive services. 

In contrast, from 1981 until 1993, HHS did little apart from routine
carrier notification to inform providers of Medicare coverage for
pneumococcal immunization.  Moreover, the Department did little
during this period to educate beneficiaries of vaccine availability,
apart from briefly announcing vaccine availability in Medicare
Handbooks and a 1982 Social Security check insert.\8

Supplementing these efforts, NIA has conducted activities to educate
health care providers on the vaccine and its indications by sending
printed material to members of several medical associations.  PHS
recently launched its "Put Prevention Into Practice" initiative,
which will publish potentially effective materials on the vaccine,
but providers must purchase these materials. 

Among the agencies we reviewed, the bulk of expenditures related to
influenza and pneumococcal immunization were made by HCFA in the form
of reimbursements to providers for immunization services.  We found
that only modest sums were spent on supplementary activities to
promote use of these benefits.  NVPO and CDC clearly acknowledge the
scope of the public health problem associated with influenza and
pneumococcal disease, but HHS refers to language in the legislative
history of fiscal 1990-95 appropriations in explaining PHS' low
expenditures on activities related to improving these immunization
rates.  We reviewed the record of appropriations hearings and found
that HHS has not taken a leadership role in defining pneumococcal and
influenza immunization as critical public health issues for the
Congress. 


--------------------
\8 HHS officials believe, and we agree, that Social Security check
inserts are costly and would not reach the large portions of
beneficiaries who use direct deposit. 


FACTORS THAT MAY EXPLAIN LOW
IMMUNIZATION RATES
============================================================ Chapter 4

This chapter discusses what is known from HHS analyses, and from the
literature more generally, about potential reasons for the low levels
of adult immunization against pneumococcal disease and influenza. 
Although the data are limited, they suggest both reasons for the
current rates and ways to increase them.  Below, we distinguish
between explanations linked to consumer behavior and explanations
based on provider behavior. 


   INFLUENCES ON VACCINE
   CONSUMERS' BEHAVIOR
---------------------------------------------------------- Chapter 4:1

Among the factors that may explain consumers' low demand for
pneumococcal and influenza vaccination are their awareness of vaccine
availability; attitudes about disease susceptibility and severity;
and concerns about vaccine side effects, safety, and efficacy.  In
appendix I, we briefly describe the information HHS has collected on
influences on consumer behavior that may have led to low immunization
rates and note the limitations of these data. 

Recent evidence indicates that consumers lack awareness of
pneumococcal vaccine.  For influenza vaccine, we found that consumers
reported misconceptions about vaccine efficacy and safety, disease
severity, and their own susceptibility to the disease.  These factors
may help explain low immunization rates, but it is not clear how much
of an impact on those rates can be achieved by addressing these
factors alone. 


      AWARENESS OF VACCINE
      AVAILABILITY
-------------------------------------------------------- Chapter 4:1.1

A Gallup poll conducted in the fall of 1993 found that only 25
percent of all adults 55 years old or older were aware that a safe,
effective pneumococcal vaccine exists.\1 However, a high level of
vaccine awareness does not necessarily ensure high vaccination rates: 
a 1987 CDC study of elderly residents in two Georgia counties found
that 90 percent were aware of the flu vaccine, yet only 55 percent
said they had received it within the past year.\2


--------------------
\1 Voluntary Hospitals of America/Gallup Poll, fall 1993. 

\2 This vaccination rate is more than 20 percentage points higher
than the 1987 national rate for elderly people, but the sample is
representative only of certain counties in Georgia. 


      BELIEFS ABOUT SUSCEPTIBILITY
      TO DISEASE
-------------------------------------------------------- Chapter 4:1.2

Consumers are probably more likely to seek a particular preventive
service if they believe they may be susceptible to the disease it
prevents.  National surveys conducted in 1977-78 by Opinion Research
Corporation (ORC) indicate that adults of all ages tended to see
themselves as more susceptible to influenza than to any other
vaccine-preventable disease.\3 Nonetheless, survey data from persons
who did not receive immunization in the recent Medicare Influenza
Demonstration revealed that the most common reason for not getting
the flu vaccine was the belief that one was healthy and did not need
it.  (See appendix I, table I.2.)

Data on beliefs about susceptibility to pneumonia are more sparse. 
However, almost 70 percent of elderly Hawaiians who responded to a
1988 survey recognized that pneumonia is a more common cause of
illness in people over 65 than in younger people. 


--------------------
\3 Pneumonia was not included in the list of diseases that
respondents considered. 


      BELIEFS ABOUT DISEASE
      SEVERITY
-------------------------------------------------------- Chapter 4:1.3

Research also suggests that consumers may be more likely to seek a
preventive service if they view the disease it prevents as a serious
matter.  With respect to flu, the ORC survey found that adults of all
ages tended to perceive influenza as the least serious
vaccine-preventable disease of adulthood.  Survey data from the 1988
Hawaii Pneumococcal Disease Initiative indicated that 78 percent of
elderly respondents viewed pneumonia as a serious disease, and 57
percent viewed influenza as a serious disease.  According to CDC,
influenza-attributable death is 90 percent higher than reported in
current vital statistics (that is, nearly twice as high as current
reports). 


      BELIEFS ABOUT VACCINE SIDE
      EFFECTS, SAFETY, AND
      EFFICACY
-------------------------------------------------------- Chapter 4:1.4

Concerns about vaccine side effects, safety, and efficacy were
frequently cited reasons for not receiving influenza vaccination by
elderly residents of the 10 communities that participated in the
Medicare Influenza Demonstration.  (See appendix I, table I.2.)
Similarly, CDC's 1987 survey in Georgia found that 73 percent of
respondents who were aware of the flu vaccine believed that it caused
illness, did not protect against influenza, or was unnecessary.\4 Of
those who were aware of the pneumococcal vaccine, 36 percent believed
that it would not prevent pneumonia or would make them sick. 

Negative attitudes lingering from the 1976 swine flu vaccine
initiative may color current perceptions about flu shots in
general.\5 When respondents were asked in a 1977 ORC survey whether
there are "any specific vaccinations .  .  .  which you feel are
unsafe," fully 78 percent of those who said "yes" mentioned "swine
flu," whereas only 11 percent said "flu" without mentioning a
specific type.  Six months later, 59 percent mentioned "swine flu"
and fully 30 percent mentioned "flu" without indicating a specific
type. 

Negative perceptions about the flu vaccine may also be related to
misconceptions about its efficacy.  In NIA's focus groups with
elderly adults, most participants reported having had a negative
experience with the flu vaccine or said they knew someone who had. 
Although a flu-like, winter respiratory illness may be coincident to,
rather than caused by, influenza vaccination, people may conclude
that the flu vaccine either failed to work or, worse, induced the
illness.\6


--------------------
\4 This includes many people who received the vaccine, since 55
percent of respondents reported having been immunized.  However, as
we note in chap.  5, beliefs may be a less important influence than
the behavior of providers on the elderly's receipt of immunization. 

\5 In Feb.  1976, an influenza virus was isolated that was
antigenically similar to the virus implicated in the 1918 influenza
pandemic, which took over 500,000 lives in the United States alone. 
The federal government initiated a massive immunization program, and
between Oct.  1, 1976, and Dec.  16, 1976, nearly 43 million doses of
swine flu vaccine (influenza A/New Jersey/1976) were administered. 
However, the program was stopped when an increasing number of reports
of vaccine-related Guillain-Barrï¿½ Syndrome were reported.  This is a
neurologic condition that is associated with a variety of viral,
bacterial, and other infections; toxins and drugs; disorders of
various kinds; and some vaccines.  By Jan.  10, 1977, 581 cases had
been reported, of which 295 had received the swine flu vaccine. 
Researchers found that the relative risk of Guillain-Barrï¿½ syndrome
in influenza-vaccinated persons was 8.8 times greater than in
unvaccinated persons.  (See Schonberger et al., "Guillain-Barrï¿½
Syndrome Following Vaccination in the National Immunization Program,
United States, 1976-77," American Journal of Epidemiology, 110
(1979), 105-23.)

\6 In its 1986 monograph entitled New Vaccine Development: 
Establishing Priorities, the Institute of Medicine discusses "the
mistaken concept that influenza vaccines should prevent all winter
respiratory tract illnesses.  Any acute illness that is experienced
in the winter following receipt of an influenza vaccine may be
attributed [erroneously] to vaccine failure.  In fact, there are
other acute virus infections that cause illness in all members of the
community, including those vaccinated against influenza."


   INFLUENCES ON PROVIDERS'
   BEHAVIOR
---------------------------------------------------------- Chapter 4:2

In this section, we examine potential explanations of low
pneumococcal and influenza immunization rates that focus on
providers' knowledge or behavior.  Evidence suggests that physician
recommendation is a strong motivator to accept vaccination,
regardless of patient attitudes.  Thus, we consider physicians'
knowledge, attitudes, and practices, as well as institutional
practices within hospitals, health maintenance organizations, and
nursing homes.  We find evidence that suggests missed opportunities
to offer vaccine to elderly persons in physicians' practices and
institutional contexts and failure in many cases to maintain
immunization records.  In appendix II, we briefly describe the
information HHS has collected on provider-based factors that have
been linked to low immunization rates and note the limitations of
these data. 


      PHYSICIAN KNOWLEDGE AND
      ATTITUDES
-------------------------------------------------------- Chapter 4:2.1

The available literature suggests that most primary care physicians
know about the seriousness of pneumococcal and influenza disease and
that half or more of these providers are familiar with the
recommendations for vaccination.  Moreover, most tend to have
favorable attitudes about vaccine safety and efficacy, though some
doubts about vaccine efficacy linger among a minority of physicians. 
For example, in 1980, CDC found that about 90 percent of primary care
physicians were aware and supportive of flu vaccination
recommendations for the elderly.\7

Fewer physicians knew the indications for pneumococcal vaccination. 
However, two-thirds of general and family practitioner respondents
and just over one-half of responding internists believed that elderly
people should get pneumococcal vaccination.  CDC also found that most
primary care physicians (over 70 percent) believed that influenza
vaccine is very safe, and that it is effective for at least 60
percent of patients.  Fewer than 10 percent expressed concerns about
pneumococcal vaccine safety or effectiveness. 

These findings are consistent with more recent results from focus
groups run by the National Institute on Aging in 1993 and findings
from the 1988 Hawaii Pneumococcal Disease Initiative, which found
that among the 35 percent of physicians responding to a survey,
roughly half recognized age over 65 as an indication for flu and
pneumococcal immunization.  HHS officials commenting on this report
noted a continuing need for provider education, but agreed with our
conclusion that physicians' vaccination practices should be the major
focus of attention. 

Medical education in adult immunization and vaccine-preventable
disease is brief but widespread.  In a 1991 survey of U.S.  medical
schools and primary care residency programs, CDC found that almost 90
percent of medical schools reported teaching about influenza,
spending an average of 30 minutes to 1 hour on the subject.  In
addition, about one-third of internal medicine residency programs
reported teaching about vaccine-preventable disease in adults,
prevention of these diseases, and vaccination indications.  Although
HHS officials argued that current instructional practices are
insufficient, it remains unclear whether or to what extent
enhancement of routine medical instruction would affect provider
practices.\8


--------------------
\7 Market Facts, "Attitudes and Practices of Private Physicians
Related to Influenza and Pneumococcal Immunization, 1980, Volume I."
Final report submitted to CDC, Jan.  30, 1981. 

\8 A Minnesota study on influenza immunization in hospital settings
recently compared the effect of physician education to that of
physician reminders and standing orders for immunization by a nurse. 
It found that education was the least effective of the three
approaches, both in terms of the percentage of patients offered
vaccine and the percentage who received it.  See R.J.  Krouse et al.,
"Hospital-Based Strategies for Improving Influenza Vaccination
Rates," Journal of Family Practice, 38 (Mar.  1994), 258-61. 


      PHYSICIAN PRACTICES
-------------------------------------------------------- Chapter 4:2.2


         RECOMMENDATIONS TO
         PATIENTS
------------------------------------------------------ Chapter 4:2.2.1

The significance of a physician's vaccination recommendation has been
clearly demonstrated.  Its absence acts as a barrier to vaccine
receipt; its presence is a motivator to get vaccinated.  Figure 4.1
shows the relationship between physician recommendations and the
immunization rates for patients with positive and negative attitudes
toward vaccination. 

Most surveyed physicians report that they recommend vaccination to
their patients for whom it is indicated (i.e., elderly persons and
those with high-risk conditions).  Evidence shows, however, that
neither physicians' knowledge nor their self-reported implementation
of vaccination recommendations is a reliable predictor of their
actual immunization practices.  For example, although almost all
primary care physicians surveyed by ORC in 1980 believed and
recommended that high-risk patients should be vaccinated and reported
recommending the flu vaccine to their high-risk patients, they
reported vaccinating only about one-half of these patients, on
average, and only about one-third of their non-high-risk elderly
patients.  An unknown number of patients may have refused their
physician's recommendation. 

Stronger evidence of a discrepancy between physicians' immunization
knowledge or attitudes and their practices comes from a study
conducted at a primary care clinic in Milwaukee in the mid-1980s.\9
Of the 92 physicians practicing at this clinic, over 75 percent knew
flu vaccine recommendations, contraindications, and objectives, and
two-thirds believed the vaccine was between 70- and 90-percent
effective.  Yet when medical records were examined from 3 peak months
of the 1984-85 flu season, only 41 percent of these physicians'
eligible patients had been offered vaccine.  Rates of offering
vaccine varied widely across physicians, from zero to 90 percent,
with vaccination refused by only 9 percent of those to whom it was
offered. 

   Figure 4.1:  Relationship
   Between Physician
   Recommendation and Immunization
   Rates

   (See figure in printed
   edition.)

Source:  "Adult Immunization:  Knowledge, Attitudes, and Practices -
DeKalb and Fulton Counties, Georgia, 1988," Morbidity and Mortality
Weekly Report, CDC, 37:4 (Nov.  4, 1988), 657-61; and Walter W. 
Williams, "Hawaii Pneumococcal Disease Initiative:  Surveys of
Consumer and Physician Knowledge, Attitudes, and Practices," 26th
National Immunization Conference Proceedings, St.  Louis, June 1-6,
1992. 


--------------------
\9 Paul W.  McKinney and Gary P.  Barnas, "Influenza Immunization in
the Elderly:  Knowledge and Attitudes Do Not Explain Physician
Behavior," American Journal of Public Health, 79:10 (Oct.  1989),
1422-24. 


         RECORD-KEEPING
------------------------------------------------------ Chapter 4:2.2.2

Maintaining an immunization record is a basic aspect of providing
vaccine-related care.  However, only 42 percent of internists
surveyed in 1987 by the American College of Physicians reported
maintaining immunization data for their patients.  Among the types of
preventive and diagnostic data covered by the survey, immunization
status was among the least frequently recorded, outranking only
information on sexual activities and seat-belt use. 

Interestingly, most of the internist participants in NIA's focus
groups mentioned forgetting as an important reason why they had not
administered the pneumococcal vaccine to more patients.  Physicians
explained that patients usually are in the office for other reasons,
and vaccination is relatively low on their list of priorities.\10

Another factor that apparently contributes to suboptimal immunization
practices is that, according to a 1988 CDC survey of all physicians
practicing in Hawaii, most of those responding did not consider
vaccination to be a part of their practice. 


--------------------
\10 Chap.  5, on effective vaccination strategies, presents strong
evidence that methods of reminding physicians to vaccinate eligible
patients significantly increase vaccination rates. 


      INSTITUTIONAL PRACTICES
-------------------------------------------------------- Chapter 4:2.3


         HOSPITALS
------------------------------------------------------ Chapter 4:2.3.1

Several studies have shown that hospitals admit patients at high risk
of pneumococcal and influenza disease and miss opportunities to
vaccinate them before their discharge.  An analysis of the medical
records of 1,633 Medicare beneficiaries in the Shenandoah region of
Virginia with any type of pneumonia admission to hospitals in 1983
showed that 62 percent of these beneficiaries had been discharged at
least once from a hospital (often from the same hospital) in the same
region in the previous 4 years.  Almost 90 percent of these patients
had high-risk medical conditions listed on their previous discharge
summaries.\11 Additional research, conducted in the United States and
the United Kingdom, showed that approximately two-thirds of patients
hospitalized with pneumococcal bacteremia during the study period had
been discharged at least once in the preceding 3 to 5 years.\12
Similarly, a Canadian study found that although only 8 percent of the
elderly in Manitoba had been discharged from a hospital during the
1982-83 vaccination season, this group accounted for almost 45
percent of subsequent influenza-associated hopitalizations and fully
two-thirds of all hospital deaths from influenza-associated illness. 
Moreover, HHS officials reported that a survey of medical/surgical
hospitals completed in 1994 found that over 60 percent of responding
hospitals had no policy for vaccinating inpatients or outpatients
against pneumococcal disease or influenza. 


--------------------
\11 David S.  Fedson, "Clinical Practice and Public Policy for
Influenza and Pneumococcal Vaccination of the Elderly," Clinics in
Geriatric Medicine, 8:1 (Feb.  1992), 183-99. 

\12 John S.  Spika, David S.  Fedson, and Richard R.  Facklam,
"Pneumococcal Vaccination:  Controversies and Opportunities,"
Infectious Disease Clinics of North America, 4:1 (Mar.  1990). 


         HEALTH MAINTENANCE
         ORGANIZATIONS
------------------------------------------------------ Chapter 4:2.3.2

The Health Maintenance Organization Act of 1973 (as amended) mandates
immunizations as one of the basic services to be included in the
benefits offered by federally qualified HMOs.  In 1987-88, CDC
commissioned a survey of HMOs with 25,000 members or more that had at
least 3 years of operational experience, but received responses from
less than 25 percent of them.\13 Among those HMOs responding to the
survey, fewer than 50 percent had written policies specifying use of
vaccines for adults, fewer than 20 percent issued an immunization
record to members, high-risk members were not consistently
identified, reminder systems were generally unavailable to physicians
or members, administrative encouragement was lacking, promotion of
vaccine use was limited, and data management systems were not
adequate to monitor immunization levels. 


--------------------
\13 See also John P.  Mullooly et al., "Influenza Vaccination
Programs for Elderly Persons:  Cost-Effectiveness in a Health
Maintenance Organization," Annals of Internal Medicine, 121 (Dec. 
1994), 947-52. 


         NURSING HOMES
------------------------------------------------------ Chapter 4:2.3.3

HHS has not routinely monitored immunization rates in nursing homes. 
Available data on influenza immunization in nursing homes suggest
that vaccination rates may have improved between the 1980s and 1990s,
but that they are still quite variable across facilities.  In the
early and mid-1980s, findings from CDC's studies of 67 nursing homes
in six states showed that, on average, only 55 to 65 percent of
nursing home residents were vaccinated against influenza in any given
year.  However, when Abt Associates surveyed over 500 nursing homes
as part of the Medicare Influenza Demonstration from 1990 to 1992, it
found higher overall vaccination rates of about 70 percent, on
average.  The studies found that having a vaccination policy, not
requiring a physician's order for vaccination, and not requiring
patient consent were associated with slightly higher vaccination
rates.  CDC also found a significant difference in vaccination rates
between homes requiring consent from family members, which had
vaccinated an average of 57 percent of patients, and homes that did
not require familial consent, which had vaccinated 90 percent. 


   SUMMARY
---------------------------------------------------------- Chapter 4:3

We identified several factors that may help explain why pneumococcal
and influenza immunization rates are below HHS goals.  We found that
consumers lack awareness of the availability of pneumococcal vaccine. 
In the case of influenza vaccination, public awareness is high, but
elderly people tend to underestimate the seriousness of, and their
susceptibility to, influenza-related disease.  Moreover, recent data
suggest that consumers may have exaggerated concerns about influenza
vaccine side effects, safety, and efficacy.  However, it is difficult
to accurately predict the extent to which addressing attitudinal
factors alone might increase vaccination rates above current levels. 

Regardless of the patient's personal attitudes about the vaccine, a
physician's recommendation appears to be a strong motivator for a
patient to get vaccinated.  However, evidence suggests that
physicians' actual immunization practices are often inconsistent with
their intentions or self-reported practices.  Forgetting to offer
vaccine and the perceived limits or demands of a physician's practice
are more plausible explanations for this than lack of knowledge;
available evidence suggests that most physicians know basic facts
about pneumococcal and influenza disease and that half or more are
familiar with vaccine recommendations. 

With respect to the role of health care organizations, limited data
from the late 1980s suggest poor immunization practices in HMOs, and
data from the mid-1980s imply uneven immunization practices in
nursing homes.  Importantly, we found strong evidence of missed
opportunities to offer vaccination to high-risk patients before their
discharge from hospitals. 


PROMISING IMMUNIZATION STRATEGIES
============================================================ Chapter 5

We identified four interventions that show some promise of increasing
pneumococcal and influenza immunization:  (1) reminder contacts with
potential vaccinees, (2) physician reminder systems, (3) issuance of
standing orders in hospitals for immunizing patients before
discharge, and (4) practice-based tracking systems.  Although public
information campaigns and vaccination clinics have been associated
with successful immunization efforts, their independent impact on
immunization rates has not been rigorously tested. 


   REMINDER CONTACTS WITH
   POTENTIAL VACCINEES
---------------------------------------------------------- Chapter 5:1

Findings from controlled studies and randomized clinical trials show
that providing a reminder to potential vaccinees is an effective
means of increasing adult immunization rates.\1 Two studies have
shown 100-percent greater immunization rates among patients who are
sent well-designed postcard reminders, as compared with "neutral"
postcard reminders or no reminder.  Such reminders establish direct
patient contact; come from an authoritative source; state vaccination
recommendations; provide information about disease susceptibility and
risk, and about vaccine cost, safety, and efficacy; and provide
information about where to obtain vaccination.  This finding is
consistent with the views of most project coordinators from the
Medicare Influenza Demonstration, who concluded that a letter to
beneficiaries from the HCFA Administrator was the most effective
immunization strategy employed.  (See appendix IV.)\2


--------------------
\1 See, for example, Eric B.  Larson et al., "Do Postcard Reminders
Improve Influenza Vaccination Compliance?  A Prospective Trial of
Different Postcard `Cues,'" Medical Care, 20:6 (June 1982), 639-48;
Eric B.  Larson et al., "The Relationship of Health Beliefs and a
Postcard Reminder to Influenza Vaccination," Journal of Family
Practice, 8:6 (1979), 1207-11; and Ronald Brimberry, "Vaccination of
High-Risk Patients for Influenza:  A Comparison of Telephone and Mail
Reminder Methods," Journal of Family Practice, 20:4 (1988), 379-400. 

\2 "Medicare Influenza Vaccine Cost-Savings Study:  Evaluation
Report" (Cambridge, Mass.:  Abt Associates, Mar.  22, 1993), p.  30. 


   PHYSICIAN REMINDER SYSTEMS
---------------------------------------------------------- Chapter 5:2

The effectiveness of interventions that remind physicians to offer
vaccine supports the notion that physicians' failure to carry out
preventive health measures results from oversight rather than
intentional disregard.  Several carefully controlled studies have
demonstrated that physician reminder systems effectively increase
preventive health practices in general, and pneumococcal and
influenza vaccination in particular. 

One study tested the effect of incorporating an age- and
gender-specific checklist of preventive health guidelines into
ambulatory care patients' medical records.  Physicians who were
randomly assigned checklists had significantly higher compliance
across a range of preventive measures, their utilization of influenza
vaccine doubled, and their utilization of pneumococcal vaccine
increased fourfold over physicians without checklists.\3

In another study, physicians and patients were randomly assigned to
medical clinics that either did or did not append checklists of
recommended preventive guidelines to patient charts.  After 4 months,
42 percent of patients seen in checklist clinics had received
pneumococcal vaccine, whereas only 5 percent of patients seen in
clinics that did not use checklists had received the vaccine during
the same period.  Similarly, at the end of the intervention, 36
percent of the "checklist patients" had received influenza vaccine,
and only 4 percent of the others had.\4

Other research has demonstrated the effectiveness of computer-based
physician reminder systems.  In a study where medical records were
electronically stored and reminders generated for each patient,
physicians who had been reminded were twice as likely to provide
influenza vaccine and over four times as likely to provide
pneumococcal vaccine to their eligible patients, as compared to
physicians who were not reminded.\5

Finally, the effectiveness of another type of computer-based
physician reminder system has also been demonstrated.  In this study,
before a physician could order discharge papers from a hospital's
computer, two data screens would come up to remind the physician of
pneumococcal vaccine recommendations, ask about the patient's
immunization status, and inquire whether the physician wished to
order vaccine for the patient before discharge.  Fewer than 4 percent
of eligible patients received pneumococcal vaccine before this system
was implemented, as compared with 45 percent afterward.\6


--------------------
\3 Carol Cheney and Joe W.  Ramsdell, "Effect of Medical Records
Checklists on Implementation of Periodic Health Measures," American
Journal of Medicine, 83 (July 1987), 129-36. 

\4 David I.  Cohen et al., "Improving Physician Compliance With
Preventive Medicine Guidelines," Medical Care, 20:10 (Oct.  1982),
1040-45. 

\5 Clement J.  McDonald et al., "Reminders to Physicians From an
Introspective Computer Medical Record:  A Two-Year Randomized Trial,"
Annals of Internal Medicine, 100:1 (Jan.  1984), 130-38. 

\6 Carolyn M.  Clancy, Daniel Gelfman, and Roy M.  Poses, "A Strategy
to Improve the Utilization of Pneumococcal Vaccine," Journal of
General Internal Medicine, 7 (Jan.-Feb.  1992), 14-18. 


   STANDING ORDERS FOR VACCINATION
---------------------------------------------------------- Chapter 5:3

Another immunization strategy that lessens reliance on physician
compliance with adult immunization guidelines involves the issuance
of standing orders.  Following implementation of standing orders, an
urban hospital in New York increased its pneumococcal vaccination
rate from zero to 78 percent of patients for whom the vaccine was
indicated.  First, the head of the Infectious Diseases Division and
the director of the medical service issued standing orders to
immunize all eligible patients.  Then, a nurse was assigned to make
daily rounds, identify target patients, place presigned order sheets
in medical records, obtain consent, and vaccinate eligible patients
before discharge.\7

Similar results were recently obtained in community hospitals in
Minnesota, in a study which also indicated that standing orders for
immunization were more effective than physician reminders or
physician education.\8


--------------------
\7 Robert S.  Klein and Nora Adachi, "An Effective Hospital-Based
Pneumococcal Immunization Program," Archives of Internal Medicine,
146 (Feb.  1986), 327-29. 

\8 R.J.  Crouse et al., "Hospital-Based Strategies for Improving
Influenza Vaccination Rates," Journal of Family Practice, 38 (Mar. 
1994), 258-61. 


   PRACTICE-BASED TRACKING SYSTEMS
---------------------------------------------------------- Chapter 5:4

The promise of another strategy has been demonstrated in private
practice settings.  This strategy builds on a target population-based
model that has been used successfully in childhood immunization
programs and in the Medicare Influenza Demonstration.  Rather than
rely on the number of doses of vaccine distributed in a previous
vaccination season to define current goals, providers maintain
posters showing the total number of elderly patients in their
practice who should be vaccinated and graph the proportion who get
immunized as the season progresses.  A 1989 study conducted in Monroe
County, New York, showed that this strategy increased the utilization
of influenza vaccine among private practice physicians assigned to an
intervention group by 30 percent over those assigned to a control
group.\9


--------------------
\9 Joanna Buffington et al., "A Target-Based Model for Increasing
Influenza Immunizations in Private Practice," Journal of General
Internal Medicine, 6 (May-June 1991), 204-09.  When surveyed, a
majority of physicians in the intervention group felt that using the
posters created intra-office competition that had a "moderate to high
influence on immunization performance." Physicians also attributed
their enhanced utilization of influenza vaccine to increased
awareness of the actual number of elderly patients in their practice. 


   OTHER STRATEGIES
---------------------------------------------------------- Chapter 5:5


      VACCINATION CLINICS
-------------------------------------------------------- Chapter 5:5.1

Large numbers of vaccinations can be administered through public
vaccination clinics.  However, there is less definitive information
on the factors that optimize this strategy's success.  In 1988, CDC,
HCFA, and the Hawaii Department of Health established the Hawaii
Pneumococcal Disease Initiative, which employed advertised mobile
vaccination clinics to increase vaccine use among older state
residents.  Before the initiative, from 1982 to 1986, Medicare paid
for an average of 1,103 doses of pneumococcal vaccine per year.  When
the initiative began statewide in 1987, Medicare paid for almost
three times as many doses as in the previous years.  Moreover, in
each of the following 2 years, when CDC and HCFA joined the
initiative, Medicare paid for almost 13 times as many doses as in the
years before the initiative.  The fact that the number of Medicare-
reimbursed doses returned to the earlier levels when the statewide
initiative was over suggests that the vaccination clinics were
responsible for the observed increase in doses.  However, like the
increases in immunization that accompanied the use of vaccination
clinics in California and Arizona, these changes may be partly
attributable to advertising or other events that coincided with the
campaign.\10


--------------------
\10 See "Successful Strategies in Adult Immunization," Morbidity and
Mortality Weekly Report, 40:41 (Oct.  18, 1991), 700-03, 709; and
"Pneumococcal Immunization Program - California, 1986-1988,"
Morbidity and Mortality Weekly Report, 38:30 (Aug.  4, 1989), 517-19. 


      PUBLIC INFORMATION CAMPAIGNS
-------------------------------------------------------- Chapter 5:5.2

Public health initiatives often use the mass media to disseminate
information.  This strategy is frequently employed because it has the
potential to alert a broad audience relatively inexpensively by
leveraging the resources of the mass media.  Assessing the
effectiveness of public information campaigns for the purposes of
increasing immunization rates is difficult.\11

Nevertheless, such initiatives have been an integral part of
successful efforts to increase pneumococcal and influenza
immunization rates.\12


--------------------
\11 There is evidence that public information campaigns in
combination with other strategies (such as vaccination clinics and
Medicare reimbursement) are effective in increasing the levels of
pneumococcal and influenza immunization.  However, we found no study
that assessed the net effect of a public information campaign on
adult immunization rates. 

\12 See AIDS Education:  Reaching Populations at Higher Risk,
(GAO/PEMD-88-35, Sept.  1988), especially Chap.  2:  A Model for
Health Education. 


   SUMMARY
---------------------------------------------------------- Chapter 5:6

This chapter focused on four promising pneumococcal and influenza
immunization strategies:  direct reminders to potential vaccinees,
physician reminder systems, standing orders for immunization in
hospitals, and practice-based tracking systems.  The evidence in
support of the independent impact of public information campaigns and
vaccination clinics is somewhat less well developed. 

Well-designed reminders, sent directly to consumers, have markedly
enhanced vaccine use.  Mailing a letter or postcard to a potential
consumer is an opportunity to address specific vaccination-related
concerns and, possibly, to correct misperceptions.  Evidence suggests
that the most effective reminders address a set of specific concerns
(e.g., disease susceptibility, vaccine safety, and efficacy);
however, they may also influence consumer decision-making through the
same mechanism responsible for the observed impact of physicians'
recommendations for vaccination. 

Physician reminder systems--whether checklists in medical charts or
computer-based reminders--are used to remedy physicians' tendency to
omit preventive health care practices.  Similarly, the use of
standing orders in hospitals reduces the dependence on physicians'
remembering to provide vaccinations.  Higher vaccination rates also
have been achieved by transferring vaccination responsibilities to
nonphysician health care providers.  Finally, population-based
tracking systems have been used in private practice settings to
increase adult immunization rates by identifying patients in need of
vaccination. 

Although evaluating their direct impact on vaccination rates is
difficult, public information campaigns and vaccination clinics have
been part of successful immunization strategies. 


CONCLUSIONS AND RECOMMENDATIONS
============================================================ Chapter 6


   CONCLUSIONS
---------------------------------------------------------- Chapter 6:1


      MONITORING ADULT
      IMMUNIZATION RATES
-------------------------------------------------------- Chapter 6:1.1

To monitor trends in both influenza and pneumococcal immunization
rates in noninstitutionalized elderly populations, HHS has relied
primarily on the National Health Interview Survey.  These
self-reported data represent the best available information on
national immunization rates.  The Department's existing alternate
methods for monitoring vaccine use (manufacturers' vaccine
distribution reports maintained by CDC and Medicare claims data
maintained by HCFA) currently have substantial limitations for
calculating immunization rates. 

Although HHS has conducted some research on immunization in nursing
homes, it has not routinely monitored immunization rates in these
settings.  In response to our report, HHS noted that the National
Center for Health Statistics would begin collecting immunization data
from nursing homes as part of its survey efforts in fiscal year 1995
and will continue every other year thereafter.  As an indicator of
quality of care, such information could be valuable not only in
monitoring immunization rates in this high-risk population, but also
in assisting state surveyors who review nursing homes that
participate in Medicare and Medicaid.  Although HHS officials note
that HCFA's guidance to states indicates that infection control
practices should be evaluated as part of reviews of nursing homes
that participate in Medicare and Medicaid, this designation refers
generally to the use of proper hygienic practices rather than
emphasizing specific disease prevention efforts.  Reviewers might be
assisted in evaluating particular nursing homes' provision of
appropriate preventive services by more systematic information on
immunization practices in these facilities. 

Death resulting from pneumococcal and influenza disease is much more
likely in persons with risk factors such as heart or lung disease. 
Thus, monitoring of vaccination rates among these persons must allow
for more detailed analysis of potential causes for their
underimmunization.  Agency officials told us that NCHS' fiscal year
1995 survey methodology was changed to permit such analyses by
collecting data on both heart and lung conditions from a larger
portion of respondents. 


      CORRELATES OF IMMUNIZATION
      STATUS
-------------------------------------------------------- Chapter 6:1.2

Multivariate analyses of 1991 data indicate that pneumococcal and
influenza vaccination rates were low across all subgroups in the
elderly population.  However, controlling for other factors included
in CDC's analyses, elderly persons who were black or who had not
visited a physician in the past year were markedly less likely to
have received either vaccination, while those with pulmonary disease
or poor health status were slightly more likely to have been
vaccinated.  Notably, although a heart condition is a risk factor for
complications from influenza, it was not associated with increased
likelihood of influenza immunization. 


      HHS IMMUNIZATION STRATEGIES
-------------------------------------------------------- Chapter 6:1.3

In the 13 years since authorization of Medicare part B coverage for
pneumococcal vaccine, neither PHS nor HCFA has done much to enhance
its use among the elderly.  Through its reimbursement of health care
providers for immunization services, HCFA makes the bulk of HHS
expenditures related to pneumococcal and influenza immunization.  PHS
dedicates few resources to improving pneumococcal or influenza
immunization rates.  Responsible officials of PHS' NVPO, which is
charged with establishing federal vaccine priorities, indicated that
they did not anticipate increasing pneumococcal and influenza
vaccination activities or resources.  CDC officials explained that
their congressional appropriations committees have focused on child
immunization activities and that increased expenditures on
pneumococcal and influenza immunization would be inconsistent with
that focus.  However, we believe that HHS has not assumed a
leadership role in seeking funding for an adult immunization
promotional effort commensurate with the significance of this public
health problem. 


      EXPLANATIONS FOR LOW
      IMMUNIZATION RATES
-------------------------------------------------------- Chapter 6:1.4

The tenable patient-based explanations for low levels of pneumococcal
vaccination are different from those for influenza vaccination.  The
elderly are far less aware of pneumococcal vaccine than they are of
influenza vaccine.  Though generally aware of influenza vaccine, the
elderly tend to underestimate the seriousness of influenza and their
susceptibility to it.  In contrast, those elderly who are aware of
pneumococcal vaccine tend to have more accurate perceptions about the
seriousness of pneumonia and their susceptibility to this disease. 
Also, among those who are aware of the vaccines, concerns about side
effects, safety, and efficacy are more prevalent for influenza than
for pneumococcal vaccine. 

Among potential health care provider-based explanations for low
immunization rates, those that focus on gaps in providers' knowledge
are not as compelling as those addressing provider behavior.  Data
show that most physicians are familiar with recommendations and
indications but--perhaps owing to limited record-keeping or various
demands of medical practice--physicians do not consistently offer
immunization to elderly patients. 


      STRATEGIES TO IMPROVE
      VACCINE USE
-------------------------------------------------------- Chapter 6:1.5

Among the steps that could improve rates of immunization, we believe
that measures related to vaccine provision are probably more
important than measures related to consumer demand.  We base this
conclusion on three principal findings:  (1) regardless of consumers'
attitudes about pneumococcal and influenza vaccines, physicians'
recommendations are a strong motivator for patients to get
vaccinated; (2) the hospital setting appears to provide important but
largely missed opportunities for vaccinating persons at high risk of
complications from influenza or pneumonia; and (3) the strategies we
identified as promising means of improving immunization rates
generally either incorporated a recommendation for vaccination or
increased the likelihood that a physician would make such a
recommendation.  We found relatively strong evidence for the impact
of physician and patient reminder systems, use of standing orders in
hospitals, and practice-based tracking systems. 


   RECOMMENDATIONS
---------------------------------------------------------- Chapter 6:2

We recommend that the Secretary of HHS take a more active leadership
role in promoting pneumococcal and influenza vaccination among
elderly persons by (1) seeking, in the annual appropriations process,
to clarify what proportion of immunization funding should be
allocated for such activities; and (2) directing HCFA and PHS to
focus their efforts on promoting or supporting promising strategies,
such as patient and physician reminder systems, development of
standing order policies, and broad-based use of a hospital policy to
vaccinate eligible patients before discharge. 


   AGENCY COMMENTS AND OUR
   RESPONSE
---------------------------------------------------------- Chapter 6:3

Responsible officials from the Department of Health and Human
Services provided written comments on a draft of this report.  (See
appendix V.) The Department provided additional, technical comments,
which we addressed in the body of the report as appropriate. 

The Department generally agreed with us that more effort is needed to
increase rates of immunization among the elderly, particularly
against pneumococcal disease and in high-risk elderly and black
populations.  Following review of our report, Department officials
indicated that in fiscal year 1997, CDC plans to propose an
initiative in this area. 

In addition to specific comments on our recommendations, the
Department made several general comments on the report.  First, HHS
officials noted that we should use the Healthy People 2000 goals to
measure progress on these immunization rates.  These are the criteria
against which we display the most current immunization data in both
chapter 1 and the executive summary.  However, Department officials
have publicly described these goals as "modest." Moreover, as the
National Vaccine Advisory Committee has indicated, current goals for
these immunizations were originally established in 1980 to target
levels of achievement for 1990, but were then carried forward to the
year 2000 when they were not reached by 1990.  It is also important
to note that these goals are identified as reasonable targets, not as
optimal levels of immunization.\1 If the preliminary data from HCFA's
beneficiary survey are borne out in the forthcoming NHIS, it does
appear that the year 2000 goal of 60-percent immunization for
influenza could be attained, but it does not appear that the year
2000 goal for immunization with pneumococcal vaccine will be met.  We
observe that the Department agreed with us that meeting the goal for
pneumococcal immunization will require greater efforts at promoting
and supporting successful vaccination strategies. 

The Department also commented that we had not provided a detailed
analysis of the recommendations made by PHS' National Vaccine
Advisory Committee.  We acknowledge that such an analysis was not
included in the scope of our evaluation.  However, we did thoroughly
review the NVAC Report on Adult Immunization issued in January 1994
and the recommendations made by the NVAC Subcommittee on Adult
Immunization in 1990.  We found that the National Vaccine Plan does
not indicate what level of priority will be given to any of the
NVAC's 18 recommendations and 72 suggested strategies or what funds
would be used to implement any or all of them. 

The Department quoted from the NVAC subcommittee report that,
"Programs to increase awareness must not focus simply on content
knowledge.  .  .  .  They must go further and address behaviors that
affect vaccine delivery." However the Department's comment did not
specify what steps it will take to effect such behavioral change.  We
agree that the highest priority should be attributed to strategies to
change the immunization behavior of vaccine providers.  However, much
of the Department's comment suggests that emphasis will continue to
rest on the use of mass-media rather than more targeted approaches
capable of addressing provider behavior toward high-risk populations. 

The Department did not agree with our recommendation to the Secretary
to seek clarification from the Congress as to the proportion of
immunization funding that should be allocated to activities to
improve these immunization rates.  The Department stated that the
Congress had clearly guided CDC to place priority on childhood
immunization.  However, our recommendation was based on our finding
that an important reason why the Congress had not emphasized the need
for a public health role in promoting immunization against
pneumococcal disease and influenza was that HHS had not taken a
leadership role in promoting adult immunization to the Congress. 

With respect to our second recommendation, the Department has
indicated that it plans to continue its current activities to
increase provider and beneficiary awareness of the benefits of
immunization.  Although the Department is correct that increasing
such awareness is among the goals cited by the NVAC's Subcommittee on
Adult Immunization, the subcommittee has also identified the
importance of support for specific strategies, such as those included
in our second recommendation.  We found that these
strategies--patient and provider reminder systems, use of standing
orders for vaccination, and hospital policies to vaccinate high-risk
patients before discharge--are likely to be more effective than the
awareness promotion activities that HHS has indicated it will
continue to pursue. 

Although the Department apparently agrees, it does not specify what
will be done to support or encourage the recommended strategies. 
Moreover, given HHS' conclusion regarding congressional priorities
for immunization funding, it is unclear how the Department could
substantially increase its promotion of pneumococcal and influenza
immunization among older adults without addressing our first
recommendation--that it seek congressional clarification about what
proportion of immunization funding should be allocated for this
purpose. 


--------------------
\1 The Healthy People 2000 Review 1993, which documented progress
toward year 2000 disease objectives, noted that the rate of
epidemic-related pneumonia and influenza deaths among persons over 65
and the rate of their restricted-activity days because of
pneumonia-related illness actually increased between 1987 and
1992--moving away from established goals. 


HHS DATA COLLECTION ON FACTORS
THAT INFLUENCE VACCINE CONSUMERS'
BEHAVIOR
=========================================================== Appendix I


   DATA COLLECTION EFFORTS
--------------------------------------------------------- Appendix I:1

Between the late 1970s and 1994, HHS undertook five studies to
collect data on consumer-based influences on receipt of immunization. 
Table I.1 identifies data collection agencies, describes major
characteristics of study designs, shows when studies were conducted,
and indicates whether information was collected on pneumococcal
vaccination, influenza vaccination, or both. 



                                    Table I.1
                     
                       HHS Data Collection on Factors That
                      Influence Vaccine Consumers' Behavior

                                                           Pneumococcu  Influenz
Organization             Study design              Year    s            a
-----------------------  ------------------------  ------  -----------  --------
Opinion Research         Two nationally            1977-   No           Yes
Corporation              representative surveys    78
                         of adults of all ages

Centers for Disease      Survey using a nonrandom  1988    Yes          Yes
Control                  sample of 700 elderly in
                         two counties in Georgia

CDC and Hawaii           Survey using a nonrandom  1988    Yes          Yes
Department of Health     sample of 14,000 elderly
                         Hawaiians

Abt Associates           Three surveys using       1990-   No           Yes
                         random samples of         92
                         residents from 10
                         communities that
                         participated in the
                         Medicare Influenza
                         Demonstration Project

National Institute on    Four focus groups with    1992    Yes          No
Aging                    elderly men and women
--------------------------------------------------------------------------------
Source:  ORC, CDC, Abt Associates, and NIA. 

In 1977 and 1978, adults of all ages were surveyed by the Opinion
Research Corporation about six vaccine-preventable diseases,
including influenza but not pneumococcal infections.  The survey (1)
examined the relationship between past experiences with vaccinations
and current desires to receive, or to have one's children receive,
them; and (2) established baseline data on a variety of perceptions
about vaccines. 

HHS did not collect information on consumer-based barriers to
pneumococcal vaccination until 1987 and 1988, when CDC conducted two
studies of elderly respondents, one in two counties in Georgia and
the other in Hawaii.  Both studies assessed vaccine awareness and
various related attitudes; however, the findings from these studies
are not generalizable beyond the study participants owing to the use
of nonrepresentative samples and the studies' coverage of limited
geographic areas. 

Each year from 1990 through 1992, HHS sponsored an Abt Associates
survey of Medicare beneficiaries living in 10 communities that
participated in the Medicare Influenza Demonstration.  Respondents
who had not received a flu shot during the last fall or winter were
asked whether any of 11 potential reasons for not getting the flu
shot had applied to them.  (See table I.2.) This is the only time HHS
has directly assessed Medicare beneficiaries' reasons for not getting
vaccinated. 



                               Table I.2
                
                Medicare Beneficiaries' Reasons for Not
                      Receiving Influenza Vaccine

Reason                                                Number   Percent
--------------------------------------------------  --------  --------
Was healthy and didn't need it                         2,463        55
Heard you can still get the flu after getting the      1,703        38
 shot
Heard the shot can cause flu                           1,670        37
Worried about the side effects                         1,667        37
Never thought about it                                 1,292        29
Had a flu shot in the past and got the flu anyway        774        17
Doesn't like the shots or needles                        657        15
Doctor did not mention it                                612        14
Doctor recommended against it                            416         9
Didn't want to spend the money                           333         7
Has vaccine allergy                                      133         3
----------------------------------------------------------------------
Source:  Medicare Community-Dwelling Beneficiary Survey, Abt
Associates, 1992. 

In 1992, the National Institute on Aging commissioned four focus
groups on pneumococcal vaccination.  Most participants were 65 years
old or older, and they were asked to discuss their attitudes toward
preventive health care and vaccinations, their familiarity with the
pneumococcal vaccine, and their reactions to information about it. 


   LIMITATIONS OF THE DATA
--------------------------------------------------------- Appendix I:2

We found that all of the studies we reviewed are limited in at least
one respect that is important to our review.  Only the ORC survey is
nationally representative, but it omits pneumococcal vaccine and was
conducted before Medicare coverage of pneumococcal and influenza
vaccination.  CDC's studies are more current, but they are not
nationally representative, and they do not examine why individuals
failed to get vaccinated.  The Abt surveys inquire about reasons for
not receiving influenza vaccination, but they do not include
pneumococcal vaccine, nor are they nationally representative. 


HHS DATA COLLECTION ON FACTORS
THAT INFLUENCE VACCINE PROVIDERS'
BEHAVIOR
========================================================== Appendix II


   DATA COLLECTION EFFORTS
-------------------------------------------------------- Appendix II:1

Between 1980 and 1994, HHS undertook numerous studies to collect data
on a variety of factors that may influence providers' immunization
behavior.  Table II.1 describes these studies and indicates whether
data were collected on pneumococcal vaccination, influenza
vaccination, or both. 



                                    Table II.1
                     
                      HHS Data Collection on Provider-Based
                            Influences on Vaccination

                                                            Pneumococc  Influenz
Organization              Study design              Year    us          a
------------------------  ------------------------  ------  ----------  --------
Market Facts              Survey of a nationally    1980    Yes         Yes
                          representative sample of
                          1,000 primary care
                          physicians

CDC, state health         Surveys of between 31     1982-   No          Yes
departments, HCFA, and    and 688 nursing homes     83,
Abt Associates                                      1984-
                                                    85,
                                                    1990-
                                                    92

CDC and Hawaii            Survey of all physicians  1988    Yes         Yes
Department of Health      practicing in Hawaii
                          (n=2,152)

CDC and American Managed  Survey of a               1987-   Yes         Yes
Care and Review           representative sample     88
Association               (220 of 650) of HMOs
                          with 25,000 members or
                          more

CDC and Association of    Survey of medical         1991    Yes         Yes
Teachers of Preventive    students, medical
Medicine                  schools, and primary
                          care residency programs

National Institute on     Focus groups with         1992    Yes         No
Aging                     primary care physicians

Centers for Disease       Survey of immunization    1993    No          Yes
Control and Prevention    program grantees
--------------------------------------------------------------------------------
Source:  CDC/NIP and NIA, 1994. 

In 1980, CDC commissioned Market Facts to conduct a national survey
of primary care physicians to assess their knowledge of vaccine
recommendations, attitudes about vaccine safety and efficacy, sources
of vaccine information, and vaccination practices.  Sixty-six percent
of the sample responded.  Since 1982, CDC has directed several
studies of immunization policies and practices in nursing homes; none
has been nationally representative.  The data collected include
immunization rates and descriptive information on the organization of
influenza programs in nursing homes and factors associated with
varying rates of vaccine use across homes. 

As part of the Hawaii Pneumococcal Disease Initiative, CDC
collaborated with HCFA and the Hawaii Department of Health in 1988 to
conduct a survey of all physicians in active practice in Hawaii. 
Approximately 35 percent responded to the questionnaire, which
assessed their intentions to recommend pneumococcal and influenza
vaccines, their attitudes about vaccine safety and efficacy, and
their use of immunization records in patients' charts and vaccination
reminder systems. 

In the winter of 1987-88, CDC commissioned a study of HMO adult
immunization policies.  About 24 percent of those surveyed provided
information on pneumococcal and influenza vaccine coverage, adult
vaccination policy, promotion of adult vaccination, and immunization
practices.  In 1991, CDC commissioned a survey of U.S.  medical
schools and primary care residency programs to assess the existence,
duration, and content of education about adult immunization and
vaccine-preventable diseases of adulthood.\1

In November 1992, NIA commissioned four focus groups with primary
care physicians in public clinics and private practice in Richmond
and Philadelphia.  The groups discussed their thoughts on routine
vaccination of adults, awareness and assessment of pneumococcal
vaccine, communication with patients about the vaccine, and barriers
to administering the pneumococcal vaccine. 

CDC provided us with some preliminary information from its 1994
survey of immunization program grantees on their experiences in
providing influenza immunization as a Medicare benefit through state
and local health departments.  In addition, CDC recently compiled a
survey of hospitals' flu and pneumococcal immunization policies and
provided major findings in comments on our draft report. 


--------------------
\1 At the time of our review, CDC was planning another physician
survey, but it was not designed to be nationally representative. 


   LIMITATIONS OF THE DATA
-------------------------------------------------------- Appendix II:2

In addition to the limitations mentioned above in connection with
individual studies, we note that HHS lacks recent information from a
representative sample of physicians, including specialists such as
cardiologists and pulmonary doctors who regularly see patients at
high risk for pneumonia and influenza.  (Although the Department
conducted a detailed and informative national survey of primary care
physicians in 1980, it was completed before Medicare coverage was
offered for either vaccine.) HHS has also lacked information on
vaccination policies and practices from a national sample of nursing
homes.  Finally, the low response rates to physician and HMO surveys
also present a barrier to a fuller understanding of the reasons for
low immunization rates. 




(See figure in printed edition.)Appendix III
SAMPLE NOTICE OF MEDICARE COVERAGE
FOR INFLUENZA VACCINE INCORPORATED
IN MAILINGS ASSOCIATED WITH
MEDICARE CLAIMS
========================================================== Appendix II




(See figure in printed edition.)Appendix IV
ADMINISTRATOR'S LETTER TO
BENEFICIARIES DURING THE MEDICARE
INFLUENZA DEMONSTRATION
========================================================== Appendix II




(See figure in printed edition.)Appendix V
COMMENTS FROM THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES
========================================================== Appendix II



(See figure in printed edition.)



(See figure in printed edition.)



(See figure in printed edition.)



(See figure in printed edition.)



(See figure in printed edition.)


MAJOR CONTRIBUTORS TO THIS REPORT
========================================================== Appendix VI


   PROGRAM EVALUATION AND
   METHODOLOGY DIVISION
-------------------------------------------------------- Appendix VI:1

Sushil K.  Sharma, Assistant Director
Betty A.  Ward-Zukerman, Assignment Manager
Jason S.  Lee, Project Manager
Venkareddy Chennareddy, Referencer
Elizabeth W.  Scullin, Communications Analyst


*** End of document. ***