```
Vaccines for Children: Reexamination of Program Goals and Implementation
Needed to Ensure Vaccination (Chapter Report, 06/15/95, GAO/PEMD-95-22).

More than 95 percent of the nation's children receive recommended
vaccinations by the time they enter school.  Preschool children were
overrepresented, however, in the widespread measles outbreaks of
1989-91, a situation attributed to underimmunization. The Vaccines for
Children Program, created in 1993, is intended to boost immunization
coverage for children by reducing the costs of the vaccines for their
parents.  Yet GAO concludes that the cost of vaccine for parents has not
been a major barrier to childrens' timely vaccination. Moreover, the
Centers for Disease Control cannot guarantee that the program will reach
pockets of need--areas or populations in which immunizations rates are
low and the risk of disease is high.  GAO concludes that better use of
Medicaid, public health clinics, and other health providers may hold a
better promise of immunizing children against disease at a cost lower
than that of the program.  GAO summarized this report in testimony
before Congress; see: Vaccines for Children: Refocusing the Program's
Goals and Implementation, by Kwai-Cheung Chan, Director of Program
Evaluation in Physical System Areas, before the Subcommittee on Health
and Environment, House Committee on Commerce. GAO/T-PEMD-95-23, June 15,
1995 (18 pages).

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

 REPORTNUM:  PEMD-95-22
     TITLE:  Vaccines for Children: Reexamination of Program Goals and 
             Implementation Needed to Ensure Vaccination
      DATE:  06/15/95
   SUBJECT:  Immunization services
             Immunization programs
             Children
             Health care cost control
             Infectious diseases
             Disadvantaged persons
             State-administered programs
             Health surveys
             Preschoolers
IDENTIFIER:  Head Start Program
             Aid to Families with Dependent Children Program
             CDC Childhood Immunization Initiative
             CDC Vaccines for Children Program
             Federal Immunization Grant Program
             Special Supplemental Food Program for Women, Infants, and 
             Children
             WIC
             AFDC
             STARS
             
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Cover
================================================================ COVER

Report to Congressional Requesters

June 1995

VACCINES FOR CHILDREN -
REEXAMINATION OF PROGRAM GOALS AND
IMPLEMENTATION NEEDED TO ENSURE
VACCINATION

GAO/PEMD-95-22

Vaccines for Children

(973422)

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

  ACIP - Advisory Committee on Immunization Practices
  AFDC - Aid to Families with Dependent Children
  CDC - Centers for Disease Control and Prevention
  CII - Children's Immunization Initiative
  DTP - Diphtheria and tetanus toxoids and pertussis vaccine
  GAO - U.S.  General Accounting Office
  HCFA - Health Care Financing Administration
  Hep B - Hepatitis B
  HHS - U.S.  Department of Health and Human Services
  Hib - Haemophilus influenza type B
  IAP - Immunization Action Plan
  MMC - Mercer Management Consulting
  MMR - Measles-mumps-rubella
  OPV - Oral polio vaccine
  VFC - Vaccines For Children
  WIC - Special Supplemental Food Program for Women, Infants, and
     Children

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

B-261272

June 15, 1995

The Honorable Dale Bumpers
United States Senate

The Honorable Scott Klug
The Honorable Ron Wyden
House of Representatives

In response to your request, this report presents (1) our review of
the evidence that vaccine cost has prevented children from being
immunized on time; (2) our evaluation of the implementation of the
Vaccines For Children program, including whether this program, as
implemented, is likely to meet the needs of underimmunized children;
and (3) some options for improving vaccine delivery to them. 

We are sending copies of this report to the Secretary of Health and
Human Services, the Administrator of the Health Care Financing
Administration, the Director of the U.S.  Public Health Service, and
the Director of the Centers for Disease Control and Prevention. 
Copies will be made available to others upon 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 II. 

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

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

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

More than 95 percent of the nation's children receive recommended
vaccinations by the time they enter school.  However, preschool
children were overrepresented in the widespread measles outbreaks of
1989-91 and this was attributed to their underimmunization.  In
conjunction with the Children's Immunization Initiative (CII), VFC is
intended to improve children's immunization coverage by reducing the
cost of vaccine for their parents.  At the request of Senator Dale
Bumpers and Representatives Scott Klug and Ron Wyden, GAO reports on
(1) the extent to which vaccine cost has prevented children from
being immunized on schedule, (2) VFC's implementation and whether
VFC, as implemented, can ensure the timely vaccination of
underimmunized children, and (3) promising options for improving
their immunization rates. 

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

Section 13631 of the Omnibus Budget Reconciliation Act of 1993
created VFC as an entitlement program to provide free vaccine to
children 18 and younger who are eligible for Medicaid or who are
American Indians or uninsured.  Underinsured children (those whose
insurance does not cover childhood vaccinations) are also eligible
for VFC vaccines but may receive them only in federally qualified
health centers or rural health clinics.  VFC's fiscal year 1995 cost
estimates included $412 million for vaccine purchase and $45.3
million for administrative expenses, such as vaccine distribution,
vaccine ordering, and operations.  The VFC legislation (signed in
August 1993) mandated that the program begin operation by October 1,
1994. 

The vaccines VFC currently provides to the states include antigens
for measles, mumps, rubella, diphtheria, tetanus, pertussis, polio,
hepatitis B, and haemophilus influenza according to a schedule set by
the Advisory Committee on Immunization Practices (ACIP) of the Public
Health Service.  The Centers for Disease Control and Prevention (CDC)
has announced that doses of influenza vaccine for high-risk children
and hepatitis B vaccine for adolescents will be added in fiscal year
1996, along with speedier catch-up immunization against measles. 
Newly approved varicella (chicken pox) and hepatitis A vaccines will
be considered.  Only one of these five new additions to the vaccine
schedule (the measles booster) will be covered by statutory price
caps (that is, contract prices that were in effect in 1993).  CDC
officials estimate that VFC purchases of the new varicella vaccine
could cost an additional $35 million to $560 million, depending on
the extent of catch-up coverage ACIP recommends.  CDC estimates that
once catch-up has been completed, the annual cost of including
varicella will range from $35 million to $70 million. 

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

From the available evidence, GAO concludes that the cost of vaccine
for parents has not been a major barrier to children's timely
immunization.  Moreover, VFC's implementation remains incomplete in
six of the seven critical areas GAO reviewed.  VFC's automation,
accountability, and evaluation mechanisms cannot measure its
provision of vaccine to children who are at high risk of
underimmunization, nor can they attribute changes in age-appropriate
immunization rates to VFC.  Thus, CDC cannot ensure that VFC will
reach pockets of need--areas or populations in which immunization
rates are low and the risk of disease is consequently high.  VFC's
shortcomings raise questions about its capacity to control vaccine
waste and abuse. 

Other options may hold better promise than VFC for improving timely
vaccination among children, potentially at lower public cost, by
reducing missed opportunities for immunization through Medicaid,
public health clinics, and other providers with whom underimmunized
children already have contact.  Moreover, CDC's analysis shows that
less than 1 percent of U.S.  counties reported measles cases in each
year of the 1980s, suggesting that specific efforts might be
efficiently targeted to improving immunization in such areas. 

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

      VACCINE COST
-------------------------------------------------------- Chapter 0:4.1

GAO did not find sufficient evidence to conclude that the cost of
vaccine for parents has been a major barrier to children's timely
immunization.  Immunization rates for preschool children at the
outset of VFC were at or near the 90-percent national goals for 1996. 
Further, immunization rates among school children exceed 95 percent
for all antigens in the basic series.  CDC- sponsored studies clearly
demonstrate that, since underimmunized children generally had access
to free vaccine before VFC began, cost is less important than missed
opportunities for vaccination during their regular contacts with
their health care providers.  The literature does identify many
barriers, including parents' lack of awareness of their children's
vaccination schedule, inadequate resources (for example, insufficient
clinic staff, insufficient or inconvenient clinic hours, and
inaccessible clinic locations), clinic policies that deter
vaccination by requiring appointments or refusing to see walk-in
patients, and various factors that cause providers to miss
opportunities to immunize children at regular visits. 

The evidence CDC has cited to document that vaccine cost is a major
barrier generally fails to separate vaccine costs, which VFC
addresses, from the larger provider fees associated with
immunization, which it generally does not.  The statute does
stipulate that providers may not deny vaccine to a child who is
unable to pay the administration fee.  However, CDC has no measures
to ensure the providers' compliance with this requirement. 

It is important to note that in certain population groups and areas,
often referred to as pockets of need, disproportionate numbers of
children are not immunized for specific diseases, creating conditions
ripe for outbreak.  For example, CDC's analysis of the measles
outbreaks in the 1980s shows that delayed immunization led to
consistently reported cases over 10 years in only 17 of 3,137 U.S. 
counties, suggesting that special efforts to improve immunization
coverage might be targeted there. 

      PROGRAM IMPLEMENTATION
-------------------------------------------------------- Chapter 0:4.2

Although CDC has devoted considerable effort and resources to
implementing VFC, and has made progress, implementation remains
incomplete, despite assurances to the contrary following GAO's July
1994 review of VFC.  In this subsequent review, as of March 1, 1995,
provider enrollment, the development of provider reimbursement
policy, order processing and automation arrangements, a vaccine
distribution system, accountability provisions, and evaluation
planning--six of VFC's seven critical implementation tasks--remained
incomplete.  The only completed task is contract negotiation for the
purchase of vaccines. 

CDC and many states cannot gauge the proportion of private
immunization providers or Medicaid providers that have been enrolled. 
Fifteen jurisdictions cannot distribute vaccine to private providers. 
The physician reimbursement policy is inconsistent with the law. 
Order-processing software that CDC developed without analyzing its
users' requirements has failed to meet their needs.  CDC cannot
ensure that the program reaches only entitled children or that
providers will serve all entitled children.  It cannot distinguish
between the number of children immunized and the number of doses of
vaccine distributed.  The states' data on providers' vaccine needs
overestimate the number of potentially eligible children and the
number of doses needed to immunize them.  Finally, although CDC has
not released evaluation plans, it is unlikely that the program's
effect can ever be assessed because important baseline data were not
collected prior to its implementation and because other efforts to
improve immunization were initiated concurrently.  In the 12 states
that already had implemented universal vaccine distribution systems,
it is not clear that VFC will have any direct effect on immunization
activities apart from changing the source of their financing.  It is
conceivable, however, that these states will add newly recommended
vaccines to their programs more quickly than they would have when
state funding was required. 

      PROMISING OPTIONS
-------------------------------------------------------- Chapter 0:4.3

CDC-funded studies have shown promise for improving immunization
rates by coordinating immunization services with large public
programs--such as the Special Supplemental Food Program for Women,
Infants, and Children and Aid to Families with Dependent Children,
which cover children who are known to be at high risk of delayed
immunization.  Research also links improved immunization with
provider-based strategies, such as assessing clinic immunization
practices and offering feedback or creating reminder and recall
systems or registries to reduce missed opportunities for
immunization.  One CDC official has testified, based on major
CDC-funded research, that immunization rates for most antigens could
be improved by as much as 15 percent simply by eliminating missed
opportunities. 

   MATTERS FOR CONGRESSIONAL
   CONSIDERATION
---------------------------------------------------------- Chapter 0:5

The Congress may want to consider refocusing VFC's goal from the
improvement of general immunization rates to the achievement of
higher immunization rates in pockets of need, where conditions are
ripe for disease outbreaks among underimmunized children.  Targeting
immunization to pockets of need should be more cost- effective than
the current approach.  In conjunction, enrollment, accountability,
automation, and evaluation efforts need to be focused on children who
are at greatest risk for delayed immunization.  Reminder and recall
or tracking systems might help identify and reach them. 

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

GAO shared a draft of this report with responsible officials of the
Department of Health and Human Services (HHS) on June 10, 1995, and
received oral comments from them on June 13, 1995.  (GAO also orally
summarized its findings in an exit conference with HHS officials on
May 2, 1995, and received oral comments.) The officials stated that
they did not agree with GAO's conclusions and believed that its views
were not balanced.  However, the comments they provided were directed
primarily to tone and technical matters; these comments have been
incorporated in the final report where appropriate. 

VFC AND ITS BACKGROUND
============================================================ Chapter 1

Senator Dale Bumpers and Representatives Scott Klug and Ron Wyden
asked us to (1) assess the evidence that children do not get
immunized when they should because vaccine cost is too high, (2)
determine the extent to which the Centers for Disease Control and
Prevention (CDC) has successfully implemented the Vaccines For
Children (VFC) program and whether VFC can help vaccinate
underimmunized children on time, and (3) identify promising options
for vaccinating those children.  Our response starts with brief
descriptions of three federal and state programs that operated prior
to VFC and the new VFC program, which began operating in 1994. 

   THREE PROGRAMS PREDATING VFC
---------------------------------------------------------- Chapter 1:1

Before 1994, Medicaid, section 317 of the Public Health Service Act
of 1962, and state programs made vaccine free to children.  By 1992,
almost half the children's vaccine sold in the United States was
being bought under these programs.  (See table 1.1.) To varying
extents, these programs have used contracts between CDC and the
vaccine manufacturers to acquire vaccines at prices substantially
lower than those charged to private sector purchasers.  (See table
1.2.)

                               Table 1.1
                
                 Publicly Purchased Doses of Children's
                  Vaccine as a Percentage of Net Doses
                Distributed in the United States, 1985-
                                  91\a

Year                                 DTP            MMR            OPV
-------------------------  -------------  -------------  -------------
1985                                 15%            38%            32%
1986                                  29             44             39
1987                                  45             51             46
1988                                  33             47             44
1989                                  35             50             44
1990                                  40             45             48
1991                                  43             51             52
1992                                  \b             54             45
----------------------------------------------------------------------
\a DTP = diphtheria and tetanus toxoids and pertussis vaccine.  MMR =
measles-mumps-rubella vaccine.  OPV = oral polio vaccine. 

\b Not available. 

Source:  Division of Immunization, Centers for Disease Control and
Prevention, Atlanta, 1993. 

                               Table 1.2
                
                   Private Catalog Prices and Federal
                Contract Prices Per Dose for Children's
                          Vaccines, 1977-92\a

Year              Private   Public  Private   Public  Private   Public
----------------  -------  -------  -------  -------  -------  -------
1977                $0.19    $0.15    $6.01    $2.42    $1.00    $0.30
 1978                0.22     0.15     6.16     2.35     1.15     0.31
 1979                0.25     0.15     6.81     2.62     1.27     0.33
 1980                0.30     0.15     7.24     2.71     1.60     0.35
 1981                0.33     0.15     9.32     3.12     2.10     0.40
 1982                0.37     0.15    10.44     4.02     2.75     0.48
 1983                0.45     0.42    11.30     4.70     3.56     0.58
 1984                0.99     0.65    12.08     5.40     4.60     0.73
 1985                2.80     2.21    13.53     6.85     6.15     0.80
 1986               11.40     3.01    15.15     8.47     8.67     1.56
 1987                8.92     7.69    17.88    10.67     8.07     1.36
 1988                6.47     3.90    19.67    11.74     7.78     1.07
 1989                6.09     3.40    19.67    11.74     9.16     1.63
 1990                6.09     2.35    19.63    10.27     9.45     1.63
 1991                5.41     1.70    20.85    10.89     9.16     1.71
 1992                5.41     1.70    20.85    10.89     9.62     1.80
----------------------------------------------------------------------
\a In current dollars, indexed at a base year of 1983.  Prices
exclude the excise taxes for the Vaccine Injury Compensation Program
in effect from 1988 to January 1993.  DTP = diphtheria and tetanus
toxoids and pertussis vaccine.  MMR = measles-mumps-rubella vaccine. 
OPV = oral polio vaccine. 

Sources:  Bureau of Labor Statistics, U.S.  Department of Labor,
Washington, D.C.; Centers for Disease Control and Prevention,
Atlanta, 1993. 

      MEDICAID
-------------------------------------------------------- Chapter 1:1.1

Low-income children who qualify for Medicaid have been entitled to
free immunization since 1965.  Today, all children younger than 6
whose family incomes are at or below 133 percent of the federal
poverty level can be vaccinated for free under this program.  State
Medicaid programs have typically set and paid providers a fee to
vaccinate these children but have differed in how they purchase
Medicaid vaccines.  A minority of states have cut costs by buying
vaccines in bulk, but in most states, individual Medicaid providers
have paid private sector rates to purchase vaccines.\1 Some but not
all state Medicaid programs have reimbursed them fully from joint
federal and state funds.  However, VFC has removed states' need to
provide matching funds for Medicaid vaccine payments; vaccines for
Medicaid-eligible children may now be financed entirely by the
federal government. 

--------------------
\1 See U.S.  General Accounting Office, Childhood Immunization: 
Opportunities to Improve Immunization Rates at Lower Cost,
GAO/HRD-93-41 (Washington, D.C.:  March 1993). 

      SECTION 317
-------------------------------------------------------- Chapter 1:1.2

Any child may be vaccinated for free in a public health clinic under
the Federal Immunization Grant Program known as the Section 317
program because it was established under that section of the Public
Health Service Act of 1962.  Based on congressional guidance, CDC's
allocations over the last 4 years for vaccines under Section 317 have
exceeded $700 million ($171 million in 1992, $190 million in 1993,
$193 million in 1994, and $149 million in 1995).  The states may use
their own funds to buy additional vaccine at the heavily discounted
federal contract price for use in the public system. 

In 1992, state Immunization Action Plans (IAPs) began as blueprints
to increase immunization rates.  Starting in 1994, substantial CDC
grants financed expanded clinic hours and staff, education and
outreach for parents and providers, registries and tracking systems,
and links between immunization services and other programs.  In
addition to Section 317 funding for vaccine, federal funding for IAPs
and incentive money rose from $46 million in 1992 to $45 million in
1993 and $161 million in 1994; the figure for 1995 is $141 million. 

      STATE PROGRAMS
-------------------------------------------------------- Chapter 1:1.3

Before 1994, when VFC was created, 12 states combined funding from
Section 317 and state and local sources to offer free vaccine to all
providers for all patients in their practices, including those who
are fully insured.\2 In these states, the advent of VFC will increase
federal financing, thus reducing the state funds needed to maintain
this service. 

--------------------
\2 Alaska, Connecticut, Idaho, Maine, Massachusetts, New Hampshire,
North Carolina, Rhode Island, South Dakota, Vermont, Washington, and
Wyoming. 

   THE VACCINES FOR CHILDREN
   PROGRAM
---------------------------------------------------------- Chapter 1:2

Section 13631 of the Omnibus Budget Reconciliation Act of 1993
created VFC, to begin by October 1, 1994, to immunize more children
and increase vaccine coverage levels nationwide by creating an
entitlement to free vaccine for children eligible for VFC and,
thereby, reduce vaccine cost as a barrier to immunization.  To
accomplish this, VFC provides free pediatric vaccine to all enrolled
private and public providers.\3 The states can also buy additional
vaccine with their own funds at the federal contract price to cover
children who are insured. 

The program covers children through 18 years of age, but CDC views
children younger than 2 as the primary targets.  From data CDC
collected from the states in January 1994, it appears that about 60
percent of the eligible children younger than 2 would qualify by
being eligible for Medicaid, less than 2 percent as American Indians,
24 percent as uninsured, and 14 percent as underinsured.\4 Many
states had difficulty estimating the numbers of children whose
insurance was insufficient, and we have not independently reviewed
the accuracy of their estimates. 

All the children who are now covered by VFC had been able to receive
free vaccine through the earlier public programs.  Under VFC,
uninsured children may now also receive free vaccine from any private
provider enrolled in the program, as well as from the public
providers from whom it was previously available to them. 
Underinsured children, however, may receive free VFC vaccine only
from federally qualified health centers and rural health clinics. 
Children eligible for Medicaid were entitled to free vaccine from
both public clinics and private providers enrolled in Medicaid.  To
the extent that these private providers now enroll in VFC, children
eligible for Medicaid will continue to receive free vaccine from
them, financed now by federal VFC funds rather than federal and state
Medicaid funds. 

Since VFC is an entitlement program, it has no fixed budget for
implementation.  However, its cost estimates for fiscal year 1995
included $412 million for vaccine purchase, $24.5 million for vaccine
distribution, $9.2 million for vaccine ordering, and $11.6 million
for operations. 

The vaccines that ACIP was recommending in October 1994 have
statutory caps that govern the prices CDC may agree to pay for them. 
New vaccines, including those for varicella (chicken pox) and
hepatitis A, do not.  CDC officials estimate that adding varicella
vaccine to the recommended schedule could cost VFC between $35
million and $560 million, depending on the breadth of catch-up
coverage recommended for children older than 18 months; the ongoing
cost would be $35 million to $70 million.\5 CDC has not estimated the
cost of adding hepatitis A vaccine, but it is expected to be lower
since this vaccine is indicated only for special populations. 
However, costs will rise further after October 1995 because ACIP has
revised its recommendations to include a measles booster shot, an
influenza vaccination for high-risk children, and an adolescent dose
of hepatitis B.\6

--------------------
\3 Private providers derive their revenues primarily from billing
patients; public providers, such as public health department clinics,
derive revenues primarily from public subsidies for general medical
care. 

\4 Although the law refers to "Indians," the program surveys
conducted by CDC have referred to "Native Americans and Alaskan
Natives."

\5 This estimate presumes that varicella vaccine will cost $15 to $30
per dose, that the recommendation will be fully implemented, and that
VFC will cover approximately 60 percent of the population.  The
estimate has been adjusted to reflect National Health Interview
Survey data for 1980-90 indicating the percentage of children who,
having contracted chicken pox, therefore have natural immunity.  CDC
predicts that ACIP is not likely to support catch-up recommendations
exceeding $134 million.  However, since these estimates were
developed, a market price of $39 was announced for varicella,
suggesting that the ongoing cost, after meeting catch-up
requirements, could be closer to $70 million than to $35 million. 

\6 Two of these vaccines, the adolescent dose of high-risk hepatitis
B vaccine and the influenza vaccine, are not covered under statutory
price caps because they were not previously incorporated in the ACIP
schedule.  CDC estimates that the fiscal year 1996 cost of buying
vaccines to immunize 30 percent of the target population for
high-risk hepatitis B, 70 percent of the target population with an
MMR booster, and 40 percent of the target population with influenza
vaccine will be $56.85 million. 

   OBJECTIVES, SCOPE, AND
   METHODOLOGY
---------------------------------------------------------- Chapter 1:3

Our objectives were to (1) assess the extent and quality of evidence
that vaccine cost delays immunization, (2) describe CDC's management
of VFC's implementation and determine whether CDC's accountability
and evaluation mechanisms can ensure that VFC can improve the timely
vaccination of underimmunized children, and (3) identify promising
ways of immunizing children known to be at high risk of delayed
immunization.  Our approach to addressing these issues included
survey research, site visits, literature syntheses, and review of
extant data. 

To assess the evidence that vaccine cost delays immunizations, we
conducted an extensive review of the literature on barriers to
childhood immunization, including synthesis of the four major studies
sponsored by CDC in the wake of recent measles epidemics to
"diagnose" and identify reasons for low immunization rates among
high-risk racial and ethnic minority inner-city preschoolers in
Baltimore, Los Angeles, Philadelphia, and Rochester (New York).  We
reviewed CDC's four studies to assess the factors associated with
underimmunization. 

Further, we convened a panel of the principal investigators of these
studies to help determine the extent to which the cost of vaccine for
parents affects their children's vaccination status.  In addition, we
met with CDC officials and reviewed agency documents, including
various types of information CDC cited to address vaccine cost as a
cause of delayed immunization.  We also reviewed literature and
interviewed CDC officials and experts to help identify promising
options for improving immunization rates among high-risk
preschoolers. 

To describe CDC's management of VFC's implementation, we reviewed the
extent to which CDC has successfully addressed seven critical tasks: 
contract negotiation, vaccine distribution, provider enrollment,
provider reimbursement, order processing and automation,
accountability, and program evaluation.\7 In December 1994 and
January 1995, we conducted two telephone surveys of state
immunization officials, one focusing on order processing and
automation and the other on the six remaining tasks.  The purpose of
our survey was to ascertain their progress in implementing the VFC
program and any problems they experienced while doing so.  Projects
in all 50 states and the District of Columbia responded. 

To ensure accuracy, we compared the survey responses to data
collected by CDC and private sector organizations.  We then collected
additional necessary data on provider enrollment, distribution, and
other implementation issues from CDC and selected states.  We
interviewed vaccine experts, federal and state officials, and
representatives of vaccine manufacturers, vaccine distributors, and
physicians.  The latter included representatives of the American
Academy of Osteopaths and the American Academy of Pediatrics.  We
also reviewed pertinent written material from the National Medical
Association. 

To assess CDC's accountability and evaluation mechanisms for VFC, we
focused on their ability to ensure that immunization rates improve
where the incidence of disease has been relatively high by monitoring
the numbers and characteristics of immunized children.  We also
looked at how these mechanisms help control waste, fraud, and abuse
in public and private settings. 

Our review was limited in that, although we conducted site visits for
the purpose of interviewing state officials, we did not assess the
quality of state distribution arrangements.  Our work was conducted
between August 1994 and May 1995 in accordance with generally
accepted government auditing standards. 

--------------------
\7 U.S.  General Accounting Office, Vaccines For Children:  Critical
Issues in Design and Implementation, GAO/PEMD-94-28 (Washington,
D.C.:  July 1994), pp.  2-3. 

VACCINE COST
============================================================ Chapter 2

Many factors keep children from being immunized on time, but there is
not sufficient evidence to conclude that what parents must pay for
their vaccine is among the major barriers.  For decades, almost all
children have had access to free vaccines through either Medicaid or
public health clinics.  Thus, it appears that just reducing the cost
of vaccine, the primary purpose of VFC, will not prevent outbreaks of
disease like those of 1989-91.  The evidence that CDC has presented
at conferences and provided us to substantiate vaccine cost as a
barrier to immunization has major problems.  Moreover, four important
CDC-sponsored studies yield contrary findings. 

   EVIDENCE FROM ANALYSIS OF
   CURRENT IMMUNIZATION RATES
---------------------------------------------------------- Chapter 2:1

Even prior to VFC, immunization rates for school-age children
exceeded 95 percent for all antigens in the basic series, regardless
of vaccine cost.  A 1994 CDC publication notes that "Immunization
levels in children who enter school or are members of other 'captive'
populations such as Head Start or day care are greater than 90% and
even higher than 95% in many instances, particularly at entry into
kindergarten."\1 (See table 2.1.) This is probably attributable to
day care, school, and Head Start entry requirements and performance
objectives. 

                               Table 2.1
                
                U.S. Immunization Levels, 1991-92 School
                                  Year

Vaccine                       Head Start     Day care\a          K-1\b
-------------------------  -------------  -------------  -------------
DTP                                  93%            94%            96%
Measles-containing                    97             96             98
Polio                                 93             94             97
----------------------------------------------------------------------
\a Licensed day care facilities. 

\b Kindergarten and first-grade immunization assessment. 

Source:  Centers for Disease Control and Prevention, "The Childhood
Immunization Initiative:  Charts, Tables, and Graphs," Atlanta, 1994,
p.  14. 

This suggests that, in at least the school-age group, vaccine cost
has not been a barrier to full immunization.  Further, even before
VFC, 1996 immunization goals for preschool children had already been
met for two of the five basic vaccine series, and they had nearly
been met for two other vaccines.  (See figure 2.1.)

   Figure 2.1:  Immunization Rates
   Two Quarters Prior to VFC
   Implementation Versus 1996
   Immunization Goals for Each
   Recommended Vaccine for
   Children Ages 19-35 Months\a

   (See figure in printed
   edition.)

\a All rates are for the second quarter of 1994, the most recent
available data as of May 1995.  The Children's Immunization
Initiative, launched in April 1993, seeks 90-percent coverage among
2-year-olds by 1996 for four of five major vaccines that the Public
Health Service Advisory Committee on Immunization Practices has
recommended:  one dose of measles-mumps-rubella vaccine and at least
three doses each of diphtheria and tetanus toxoids and pertussis
vaccine, oral polio virus vaccine, and haemophilus influenza type b
vaccine.  The goal is 70 percent for three doses of the more recently
introduced hepatitis B vaccine. 

\b Diphtheria and tetanus toxoids and pertussis vaccine. 

\c Children born before the recommendation for universal vaccination
represented 35 percent of the sample from which this rate was
calculated. 

Source:  Assessment Branch, Data Management Division, National
Immunization Program, Division of Health Interview Statistics,
National Center for Health Statistics, Centers for Disease Control
and Prevention, "Vaccination Coverage Levels Among Children Aged
19-35 Months--United States, April-June 1994," Morbidity and
Mortality Weekly Report, May 26, 1995, pp.  396-98. 

CDC officials point out that the percentage of preschoolers who have
received the full series of recommended vaccines is lower, at 68
percent (for four doses of DTP, three doses of OPV, and one dose of
measles-containing vaccine), but we have some concerns about the
meaning and interpretation of this measure.  We believe that this
statistic could create a misleading impression of the extent of
immunization problems because it counts children who are missing only
one dose the same as children who are missing several doses.  More
important, it is not meaningful in terms of assessing preparedness to
prevent specific diseases and tends to conceal the source of problems
in children's receiving specific antigens or doses. 

This indicates that cost for at least some major vaccines has not
been a major barrier to immunization insofar as it has not kept
preschool children from timely immunization.  Factors other than
vaccine cost, such as clinic policies and resources and factors that
cause providers to miss opportunities to immunize children during
regular visits, may be more salient. 

--------------------
\1 Centers for Disease Control and Prevention, "The Childhood
Immunization Initiative:  Charts, Tables, and Graphs," Atlanta, 1994,
p.  14. 

   CDC-SPONSORED RESEARCH
---------------------------------------------------------- Chapter 2:2

Even in the presence of high general immunization rates, disease can
break out locally where there are high concentrations of children who
have not been immunized against a particular disease.  Following the
1989-91 measles outbreaks, CDC analysis showed that only 17 of 3,137
U.S.  counties reported measles cases in 10 consecutive years while
53.9 percent of counties did not report any cases.  (See table 2.2.)
The counties that reported cases in more years tended to have lower
rates of preschool immunization. 

                               Table 2.2
                
                 The 17 U.S. Counties Reporting Measles
                          Every Year, 1980-89

                                                            Mean cases
                                                           per 100,000
State                      County         Measles cases     population
-------------------------  -------------  -------------  -------------
California                 Los Angeles            2,543            3.1
                           San Diego              1,370            6.3
                           Orange                   651            3.0
                           San Mateo                103            1.7
                           Alameda                  100            0.8
                           Santa Cruz                47            2.2
Florida                    Dade                     782            4.4
Hawaii                     Honolulu                 178            2.2
Illinois                   Cook                   3,420            6.6
                           Du Page                  343            4.8
Massachusetts              Middlesex                133            1.0
New York                   Kings                  1,383            6.1
                           Bronx                    732            6.2
                           Queens                   654            3.4
                           New York                 409            2.8
                           Westchester              193            2.2
Texas                      Tarrant                  194            1.9
----------------------------------------------------------------------
Source:  Bradley S.  Hersh et al., "The Geographic Distribution of
Measles in the United States, 1980 Through 1989," Journal of the
American Medical Association, 267:14 (April 8, 1992), 1939. 

Subsequent to these measles outbreaks, CDC commissioned four studies
to find out why preschool children had not been immunized on time in
Baltimore, Los Angeles, Philadelphia, and Rochester, New York.  These
studies identified geographic areas or populations in which the
incidence of disease had been relatively high--often referred to as
pockets of need--and studied immunization in these areas or groups.\2
The studies found that "financial barriers were not a factor in these
low coverage rates" but that "missed opportunities"--visits to
providers during which children are not vaccinated despite the
absence of contraindications--were.\3 They found that most of the
underimmunized children had access to free vaccine through Medicaid
or public health clinics--that is, through private or public
providers.  They had visited their providers an average of six to
eight times during a given year and could have received their
scheduled immunizations during these visits, but the providers had
failed to vaccinate them. 

The four studies identified several factors associated with missed
opportunities, including provider and clinic-related factors and
policies, such as failure to simultaneously vaccinate or accelerate
the immunization of children who were behind schedule, lack of access
to children's immunization records, and lack of organizational
support.  Opportunities for immunization were missed both when
children were well and when they were sick, but health care providers
were more likely not to vaccinate children when they were sick.  In
fact, incorrect beliefs about contraindications for immunization were
particularly important; in Baltimore, for example, opportunities were
missed at approximately 25 to 30 percent of preventive visits but at
more than 75 percent of sick-child visits.\4

--------------------
\2 For example, the study in Philadelphia concentrated on about 20
percent of the city's population residing in an area in north-central
Philadelphia.  The authors note that this area was overrepresented in
school-based studies of underimmunization and, ultimately, measles
cases.  Other studies, in Los Angeles and Baltimore, examined
geographic areas in which there were high concentrations of residents
meeting certain demographic criteria associated with low immunization
or high incidence of disease. 

\3 B.  Guyer et al., "The Baltimore Immunization Study:  Immunization
Coverage and Causes of Under-Immunization Among Inner-City Children
in Baltimore," contract 200-90-0850, Centers for Disease Control and
Prevention, Atlanta, June 1993; D.  L.  Wood et al., "Increasing
Immunization Among Latino and African American Preschool Children in
Los Angeles:  A Report to the Centers for Disease Control and
Prevention," contract 200-90-0850, National Immunization Program,
Atlanta, April 1, 1993; Allan M.  Arbeter, "Final Report:  A Study to
Increase Immunization Coverage of Inner-City Minority Children in
Philadelphia, Pennsylvania," contract 200-90-0870, Centers for
Disease Control and Prevention, Atlanta, July 2, 1993; Klaus Roghmann
et al., final report, contract 200-90-0869, Centers for Disease
Control and Prevention, Atlanta, June 14, 1993.  For more on the
Baltimore study, see V.  Keane et al., "Perceptions of Vaccine
Efficacy, Illness and Health Among Inner City Parents," Clinical
Pediatrics, 32 (1993), 2-7; B.  Guyer et al., "Immunization Coverage
and Preventive Health Care Visits Among Inner-City Children in
Baltimore," Pediatrics, 94 (1994), 53-58; N.  Hughart et al., "Do
Provider Practices Conform to the New Pediatric Immunization
Standards?" Archives of Pediatrics and Adolescent Medicine, 148
(1994), 903-35. 

\4 Baltimore investigators found that gastroenteritis, otitis media,
skin infection, and upper respiratory infection were diagnoses
commonly recorded at sick-child visits in which an opportunity to
immunize was missed without valid contraindication. 

   EVIDENCE CITED BY CDC
---------------------------------------------------------- Chapter 2:3

As evidence that vaccine cost is a barrier to timely immunization,
CDC documents cite

  -- increases in vaccine cost over the past decade;

  -- surveys showing the frequency with which private health care
     providers report referring patients to public health providers
     for immunization, their reasons for doing so, and their opinions
     regarding a universal vaccine purchase program;\5

  -- reports from health departments of greater numbers of referrals
     from private providers;

  -- surveys of parents at public clinics regarding their reasons for
     using public health clinics;\6

  -- policy studies of the relationship between health insurance
     coverage, visits to health care providers, and immunization;\7
     and

  -- comparisons of immunization rates between states that do and do
     not have universal vaccine distribution programs. 

In 1993, we pointed out the difficulty of linking higher vaccine
costs with changes in immunization rates.\8 Since then, Mercer
Management Consulting (MMC), under contract to the U.S.  Department
of Health and Human Services (HHS), has reported that 69 percent of
the increase in the cost of full immunization between 1982 and 1993
is attributable to the addition of new vaccines to the immunization
schedule (54 percent) and an excise tax (15 percent).  It is true
that vaccine prices rose rapidly in the early 1980s, but this growth
flattened considerably after the National Vaccine Injury Compensation
Program began in 1988; MMC has reported that, since 1988, per dose
revenues have not grown faster than inflation for any scheduled
pediatric vaccine. 

To determine the relationship between timely immunization and a
variety of potential barriers, we reviewed studies of the populations
of children who are at high risk of delayed immunization.  Research
cited by CDC, in contrast, tended to focus on a more narrow
investigation of particular factors, such as providers' referral
patterns.  For the purpose of assessing the role of vaccine costs in
delayed immunization, the research CDC cites suffers from several
conceptual and methodological problems:  (1) failure to distinguish
vaccine costs from other fees associated with immunization, (2)
inability to determine whether the outcomes actually measured (such
as referral to a public health clinic) were valid indicators of
eventual failure to receive timely immunization, and (3) reliance on
opinion data collected in surveys rather than analysis of the
immunization status of representative samples of children.\9

For example, CDC officials acknowledged that providers' fees in the
private sector potentially represent about 60 percent of the total
cost of full immunization (about $40 for each office visit and about
$15 for administering each dose).  However, much of the evidence they
cite fails to distinguish between the cost of vaccine, which is
addressed by VFC, and provider fees, which generally are not. 
Similarly, comparisons of immunization rates between states that do
and do not practice universal distribution prohibit accounting for
other factors that may influence these rates.\10 Finally, most of the
studies CDC cited measured physician referral as an unvalidated
substitute for measures of delay in immunization; only one of the
studies attempted to directly measure the extent of delay in
immunization.\11

This study found that 25 physicians in Minnesota vaccinated insured
children earlier with the third dose of DTP but not the first dose of
MMR.\12 However, this finding does not directly support a conclusion
that time to immunization among the various insurance groups differed
because of vaccine cost as opposed to unmeasured characteristics that
may be associated with insurance status, such as access to
transportation and parents' working hours.  Even this study reported
that, among the 84 percent of children immunized in the private
sector, only 62 percent were fully immunized at age 2 compared to 73
percent of those who were immunized in public clinics.\13 In any
case, although 68 percent of the physicians said they would refer
children with no insurance coverage to public clinics, only 8 percent
said they would refer Medicaid-covered children, who constitute most
of the population eligible for VFC.\14

--------------------
\5 H.  Ruch-Ross and K.  O'Connor, "Immunization Referral Practices
of Pediatricians in the United States," Pediatrics, 94:4 (1994),
508-13; W.  C.  Bordley et al., "Factors Responsible for Immunization
Referrals to Health Departments in North Carolina," Pediatrics, 94:3
(1994), 376; P.  Szilagyi et al., "Immunization Practices of
Pediatricians and Family Physicians in the United States,"
Pediatrics, 94:4 (1994), 517-23; J.  Schulte et al., "Changing
Immunization Referral Patterns Among Pediatricians and Family
Practice Physicians, Dallas County, Texas, 1988," Pediatrics, 87:2
(1991), 204; P.  Arnold and T.  Schenkler, "The Impact of Health Care
Financing on Childhood Immunization Practices," American Journal of
Diseases of Children, 146 (1992), 728; J.  Wright and E.  Marcuse,
"Immunization Practices of Washington State Pediatricians, 1989,"
American Journal of Diseases of Children, 145 (1992), 1033; S. 
Rosenbaum et al., Universal Distribution of Childhood Vaccines:  The
Experience of Twelve States (Washington, D.C.:  Center for Health
Policy Research, George Washington University, November 1994); R.  K. 
Zimmerman and J.  E.  Janosky, "Immunization Barriers in Minnesota
Private Practices:  The Influence of Economics and Training on
Vaccine Timing," Family Practice Research Journal, 13:3 (1993),
213-23; R.  K.  Zimmerman et al., "Barriers to Measles and Pertussis
Immunization:  The Knowledge and Attitudes of Pennsylvania Primary
Care Physicians," Department of Family Medicine and Clinical
Epidemiology, University of Pittsburgh School of Medicine,
Pittsburgh, 1994. 

\6 T.  Lieu et al., "Health Insurance and Preventive Care Sources of
Children at Public Immunization Clinics," Pediatrics, 93:3 (1994),
373-78. 

\7 Rosenbaum et al.; E.  Weissman, Falling Through the Safety Net: 
Insurance Status and Access to Health Care (Baltimore, Md.:  Johns
Hopkins University Press, 1994). 

\8 See our correspondence to the Honorable John Dingell dated July
21, 1993, and the Honorable Dale Bumpers dated July 27, 1993. 

\9 In fact, other research notes that, in some locations, substantial
proportions of parents take their children to public clinics because
of delays in receiving appointments with primary providers.  (See T. 
Lieu et al., "Health Insurance and Preventive Care Sources of
Children at Public Immunization Clinics," Pediatrics, 93:3 (1994),
373-78.) Moveover, children who clearly have financial access to
immunization may nonetheless fail to receive it in a timely manner. 
(See T.  Lieu et al., "Risk Factors for Delayed Immunization Among
Children in an HMO," American Journal of Public Health, 84:10 (1994),
1621-25.)

\10 U.S.  General Accounting Office, Childhood Immunization: 
Opportunities to Improve Immunization Rates at Lower Cost,
GAO/HRD-93-41 (Washington, D.C.:  March 1993). 

\11 See Zimmerman and Janosky, pp.  213-23, and Zimmerman et al. 

\12 Insofar as there were no equivalent findings for delay in being
vaccinated with MMR, the outcome seems to vary by vaccine rather than
insurance status.  Even in light of the large differences one might
expect among these insurance groups with regard to parental age,
education, income, or hours of employment, the authors' pairwise
comparisons found no difference that exceeded 4 months (7.8 months
for insured children receiving DTP/3, 11.6 months for uninsured
children). 

\13 From a survey by Minnesota public health officials of the parents
of 600 children randomly selected from a birth registry, cited in
Zimmerman and Janosky, p.  214. 

\14 CDC has recently cited an unpublished study as evidence to
"support providing free vaccines for both uninsured and Medicaid
children." In this study, Pennsylvania physicians who did not receive
free vaccine said they were more likely to refer Medicaid and
uninsured patients to public clinics for immunization than physicians
who did receive free vaccine, although all physicians were more
likely to refer these groups.  The physicians believed that an
average of 18 percent of the children in their practices were
hindered from being immunized on time by unspecified economic
concerns.  However, the study lacked any measure of physicians'
actual behavior, did not demonstrate that any children who were
referred actually experienced greater delays in being immunized, and
cannot attribute the differences in the physicians' self-reported
referral patterns uniquely to their receipt of free vaccine.  In any
case, all the factors considered in the study, including receipt of
free vaccine, accounted for less than a quarter of the variation in
physicians' self-reported likelihood that they would refer uninsured
children to public health clinics. 

   SUMMARY
---------------------------------------------------------- Chapter 2:4

The national immunization coverage of preschoolers is now much better
than it was before the 1989-91 measles outbreak and the mild
resurgence of pertussis and diphtheria in the late 1980s and early
1990s.  At the outset of VFC, childhood immunization was at its
highest and childhood diseases had reached historical lows.  The
studies we examined and the other sources of information available to
us did not provide sufficient evidence to conclude that the major
factor addressed by VFC, vaccine cost, has been a major barrier to
immunization.  It appears that efforts to address a variety of other
barriers may be equally or more important in further improving
immunization levels (see chapter 4). 

PROGRAM IMPLEMENTATION
============================================================ Chapter 3

The Department of Health and Human Services announced that VFC would
be implemented by October 1, 1994, and although progress has been
made, as of March 1, 1995, VFC's implementation remained incomplete. 
Here, we describe the status of the seven basic implementation tasks
we identified in July 1994:  contract negotiation, vaccine
distribution, provider enrollment, provider reimbursement, order
processing and automation, accountability, and evaluation.\1 CDC's
problems in integrating activities across these interdependent tasks
and its general approach to the management of VFC's implementation
raise concerns about its capacity to document whether the program has
met its goals.  Moreover, CDC cannot ensure that VFC will improve
immunization in pockets of need and, consequently, eliminate
conditions conducive to epidemics. 

--------------------
\1 U.S.  General Accounting Office, Vaccines for Children:  Critical
Issues in Design and Implementation, GAO/PEMD-94-28 (Washington,
D.C.:  July 1994). 

   STATUS OF IMPLEMENTATION TASKS
---------------------------------------------------------- Chapter 3:1

Since six of seven major implementation tasks we reviewed in July
1994 remained incomplete as of March 1, 1995, CDC cannot ensure that
VFC will reach children at high risk of untimely immunization because
(1) CDC does not know what proportion of providers have been enrolled
or to what extent those who have been enrolled serve high-risk
children and (2) the states are not required to report whether
children in pockets of need are receiving free vaccine and,
therefore, it will be difficult to attribute changes in immunization
rates to the program's implementation. 

Under CDC's implementation plans, the agency is to buy vaccines in
bulk in sufficient quantities to meet the needs established by the
states, which in turn are to distribute them to enrolled private and
public providers and make the providers accountable for their use. 
Accordingly, implementing VFC has required CDC to harmonize the
interests of federal financers, states, vaccine manufacturers, and
immunization providers.  The federal government, as the program's
sole financer, has an interest in ensuring economical program
administration and minimum vaccine waste and fraud.  The states stand
to benefit from the full federal financing of VFC vaccines, which
removes the need for state contributions to finance vaccines for
children eligible for Medicaid.  The manufacturers, who are selling
an increasing proportion of their vaccines to the federal government
at a substantial discount, want strong accountability mechanisms to
prevent the diversion of those vaccines to insured children from
further eroding a dwindling private market.  The immunization
providers, while willing to receive free vaccine inasmuch as it
limits their need to finance vaccine purchases until patients can be
billed, are concerned about the associated paperwork burden. 

      VACCINE CONTRACTS
-------------------------------------------------------- Chapter 3:1.1

By October 1994, CDC had signed all 15 contracts necessary to buy
vaccines in fiscal year 1995 even though 3 months before VFC was to
begin operation, in July 1994, only 4 of the 15 had been signed.  Two
problems have subsequently emerged.  First, CDC has, consistent with
VFC legislation, encouraged manufacturers to compete by guaranteeing
minimum vaccine orders to multiple bidders, but some states have
objected that CDC's order processing methods do not permit them to
guarantee physicians specific brands of vaccine.\2 Many physicians
believe that different brands of vaccine are not interchangeable. 

Second, CDC officials told us that the maximum doses of oral polio
vaccine that can be purchased under the current contract will not
meet the estimated needs of all the states for fiscal year 1995. 
This problem may only get worse, since 14 states and the District of
Columbia had yet to begin routine ordering for private providers.\3
CDC expects to exceed the annual contractual cap of 10.8 million
doses negotiated with the manufacturer by July 1995.  This would
result in a shortage of OPV for the VFC and Section 317 programs
unless CDC uses OPV from the stockpile, which CDC officials describe
as a last resort, or buys additional vaccine outside the existing
contract.  Buying OPV outside the contract at prices that exceeded
the statutory caps would create questions about CDC's ability to
comply with the law.\4 Meanwhile, the sole manufacturer of OPV
contends that the states have overestimated their need for it and
that additional purchases may not be necessary.  Lacking accurate
data on vaccine needs and usage, CDC cannot squarely address this
issue. 

--------------------
\2 Under current contracting arrangements, such a guarantee might not
be possible 100 percent of the time, but systems might be improved to
optimize the satisfaction of providers' preferences. 

\3 These 15 jurisdictions represent more than 1.3 million children,
or more than 47 percent of the children younger than 2 who the states
estimated would receive VFC vaccine from private providers. 

\4 If the OPV contract does not permit the purchase of sufficient
quantities of vaccine to meet VFC's needs, it will be important for
CDC to give VFC's acquisitions priority over those made at state
option. 

      VACCINE DISTRIBUTION
-------------------------------------------------------- Chapter 3:1.2

CDC has had problems distributing VFC vaccines to private providers. 
At first, CDC officials indicated that the law did not permit it to
reimburse manufacturers separately for delivery of vaccine purchased
under the price caps.  In apparent contradiction, after plans for a
national distribution center were dropped in August 1994, CDC
attempted to amend its contracts with four vaccine manufacturers to
provide separate payments for delivery services.  With such
arrangements, physicians in the 23 states and the District of
Columbia that had planned to rely on the now abandoned center could
then still receive their vaccines from the manufacturers.  CDC
solicited and received sole-source bids from four vaccine
manufacturers by December 1994 but withdrew its solicitation in April
1995 because many states had made alternative distribution
arrangements with CDC's financial assistance and because CDC believed
a contract with one of the four manufacturers could not be
negotiated.  CDC officials reasoned that physicians would not
participate in VFC if they were unable to receive all the vaccines
they needed. 

While the states that have decided to develop their own distribution
systems will be fully reimbursed for distribution costs through VFC,
these costs are not capped.  Other than reviewing state funding
requests, CDC has provided no guidance to the states on how to deal
with distribution costs, which differ depending on state solicitation
and contracting procedures.  As of March 30, 1995, 15 of the 24
jurisdictions (23 states and the District of Columbia) that had
expected to rely on a national distribution center had not begun
routine vaccine shipments to private providers.  They were still in
various stages of planning and implementing their own distribution
contracts or making other arrangements, such as relying on public
health personnel to deliver vaccines, allowing private providers to
pick them up, and establishing state-operated depots.  At least 2
anticipated imminent signing of distribution contracts and vaccine
shipping; 4 others had no plans to distribute vaccine to private
providers in fiscal year 1995. 

      PROVIDER ENROLLMENT
-------------------------------------------------------- Chapter 3:1.3

Enrolled private and public immunization providers must complete the
provider enrollment form, the provider profile, and patient
eligibility forms.  CDC delegated provider recruitment and enrollment
to state health departments and state Medicaid agencies.  In our
prior review, we found that as of June 28, 1994, only 5 states had
mailed enrollment forms to potential private providers.  Moreover,
CDC had no monitoring plans, intending instead to assess enrollment
from initial vaccine orders.  All but 4 of the 49 participating
states had begun their enrollment within 3 months of when the program
began in October 1994, and CDC had begun to collect data on the
number of private and public sites that had been enrolled in each
state.  However, since CDC lacks accurate national data on the
proportion and characteristics of enrolled providers, it cannot
assess VFC's capacity to improve immunization rates overall or in
pockets of need.  Poor monitoring could mean that the immunization of
children eligible for Medicaid could be disrupted.\5

--------------------
\5 Medicaid providers that see only small numbers of children might
not enroll in VFC to avoid becoming involved in an additional
program. 

         PUBLIC PROVIDERS
------------------------------------------------------ Chapter 3:1.3.1

CDC's goal in July 1994 was to enroll 90 percent of all public health
providers by October 1, 1994, including federally qualified health
centers, public health clinics operated by state health departments,
and rural health clinics.  CDC asserts that it had enrolled most
public providers (8,062) as of March 30, 1995.  However, as of April
3, 1995, CDC had no accurate estimates of the proportion of each of
the major types of clinics that states had enrolled.\6

--------------------
\6 Federally qualified health centers and rural health clinics are
the only types of providers from which underinsured children may
receive free VFC vaccine.  Tracking their enrollment is therefore
particularly important.  Data from the Health Care Financing
Administration (HCFA) and from CDC suggest that 82 percent of rural
health clinics have been enrolled.  CDC also reports that many states
indicate that all their health department clinics have been enrolled. 

         PRIVATE PROVIDERS
------------------------------------------------------ Chapter 3:1.3.2

CDC has been unable to adequately monitor the enrollment of either
private providers in general or Medicaid providers in particular. 
CDC does not know the numbers of providers who are likely to
administer pediatric care (that is, pediatricians, family
practitioners, and osteopaths) and therefore cannot accurately assess
the proportions of such providers who have been enrolled in VFC.  In
July 1994, CDC said that it hoped for 50-percent enrollment but had
no state-specific goals.  In January 1995, 46 states had begun their
enrollment but only 30 of these could provide estimates of the
proportions of immunization providers enrolled.  Of these 30, only 15
reported 50-percent enrollment or more.\7 Of the remaining 15 states,
10 reported 11 to 49 percent enrollment and 5 reported 10 percent or
less. 

About 60 percent of the children who are eligible for VFC are also
eligible for Medicaid and receive their health care through providers
enrolled in that program.  HCFA plans to terminate Medicaid vaccine
payments in October 1995 where VFC vaccines are available to private
providers.  Thus, monitoring the proportions of Medicaid physicians
who have enrolled in VFC is important to ensure that Medicaid
beneficiaries' access to immunization through their regular providers
will not be disrupted.  However, it is not clear whether HCFA can
assess Medicaid beneficiaries' access to VFC-enrolled providers in
order to determine when it is prudent to end these payments. 
Although some states have information on the enrollment of Medicaid
providers, federal officials have not asked them to collect or report
it. 

--------------------
\7 Of these 15, 10 were capable of expediting enrollment because they
either had begun universal vaccine distribution since VFC or had
implemented universal distribution programs before VFC.  The 3 states
reporting 90-percent enrollment or more had had universal programs
before VFC, but they serve less than 1 percent of the children
younger than 2 who are likely to be immunized with VFC vaccines. 

      PROVIDER REIMBURSEMENT
-------------------------------------------------------- Chapter 3:1.4

Under the law, VFC providers' fees for administering vaccine were to
be based on their actual costs for providing this service. 
Accordingly, HHS has set caps on providers' administration fees. 
However, it has based these caps on physicians' prevailing charges
instead of costs.  Consequently, in several states, permissible fees
under VFC have exceeded Medicaid vaccine administration fees by as
much as $10.  CDC's rationale for using prevailing charges was that
data on the cost of administering vaccine were insufficient when it
developed VFC's reimbursement policy and that physicians would not
otherwise enroll.  We noted in July 1994 that this policy might
create burdens for parents, who may have to pay more than under a fee
schedule based on administration costs, as stipulated in the law.\8

On January 31, 1995, HCFA officials told us that they had engaged the
Center for Health Policy Studies to collect data for designing
cost-based maximum fee schedules, but as of May 12, 1995, the
research protocol was still under review at the Office of Management
and Budget.  Since it was unavailable to us, we cannot comment on the
cost study's conclusions and recommendations.  Meanwhile, CDC is
allowing providers to apply charge-based fees for administering
vaccine until a new fee schedule becomes ready on October 1, 1995,
when VFC begins its second year. 

--------------------
\8 U.S.  General Accounting Office, Vaccines for Children:  Critical
Issues in Design and Implementation, p.  2. 

      ORDER PROCESSING AND
      AUTOMATION
-------------------------------------------------------- Chapter 3:1.5

To assist the states in ordering, tracking, and recording the costs
of VFC vaccines, during fiscal year 1994 CDC developed and
distributed a vaccine-management system called VACMAN at a cost of
just under $1 million.  This system was designed to run on a desktop
computer supplied by CDC exclusively for this purpose and to link CDC
by modem, through an electronic bulletin board, with the 64
immunization projects nationwide.  VACMAN was not designed to meet
critical VFC program requirements such as identifying children in
need of vaccine and tracking those receiving vaccines through the
program.  Rather, it was designed primarily to support order
processing.  Even in this limited area, however, VACMAN's usefulness
to the states has been sharply diminished by gaps in performance and
capability that have forced some states to turn instead to manual or
other automated systems to supplement or replace what VACMAN was
intended to provide. 

To ensure that the system would be available by the program's October
1, 1994, starting date, CDC decided not to follow sound
systems-development practices.\9 Specifically, CDC did not (1)
adequately assess its users' needs, (2) perform alternative systems
design and cost-benefit analyses, or (3) perform independent
quality-assurance testing of the software.  CDC thus limited the
program support that VACMAN can offer, failed to establish a
contingency plan for VACMAN's telecommunications links, and left
itself unable to ensure that system hardware, software, or
communications will operate as expected.  Although VACMAN is still
not complete, CDC plans multiple revisions to the software through
the end of this year. 

Because of the time constraints, and CDC's decision not to undertake
a comprehensive alternative design analysis, it did not consider the
range of VFC functions that technology could support.  CDC therefore
locked itself into a design that may not have been the best
alternative and that lacks critical program elements.  For example,
VACMAN's technical interface capability falls seriously short of
meeting the states' needs.  The states said that for VACMAN to be
useful to them, they need to link it with other systems and databases
but in many cases they cannot.  Further, CDC failed to take advantage
of existing databases, such as state welfare and Medicaid systems,
that could support the identification of children who need
immunization. 

By not adequately involving VACMAN's users in identifying their needs
before CDC implemented the system, the agency created a system that
fails to support many of VFC's functions.  As one state
representative said, "At this point we are not sure what the system
can and cannot do because of continual changes; [the] haste in which
the government has dumped this thing [on us] has contributed to most
of the problems." To identify the states' needs, CDC this past
January conferred with VACMAN's users, who identified more than 100
problems.  One key problem they noted was that VACMAN does not
provide the states with overall project fund balances; as a result,
they may not know whether they have funds to cover orders as they
place them.  Similarly, the system does not indicate whether a
vaccine is on back order; the states therefore cannot easily
determine whether or when an order will be filled.  Officials in 29
states said that they operate other systems to track and manage
vaccines, even though this sometimes involves dual data-entry and
redundant operations.  In revising VACMAN this year, it will be
imperative for CDC to correct these and other problems with the
original design. 

CDC disabled some of VACMAN's original features that have not,
therefore, been used.  CDC disabled private-provider ordering
functions when the national system for distributing vaccines to
providers was dropped.  The states can use VACMAN only for bulk
ordering, thus limiting their ability to track and account for the
vaccines ordered by private providers.  Moreover, the states perceive
VACMAN's accountability functions as limited--only 8 states reported
that VACMAN meets all their accountability needs. 

Finally, both CDC and the states rely on VACMAN's electronic bulletin
board as a 24-hour repository of order information until it is
entered into CDC's mainframe computer for review and transmission to
vaccine manufacturers.  However, CDC performed no independent
quality-assurance testing of the bulletin board and the network
environment and, therefore, has no contingency plan to guide
operations if it fails. 

--------------------
\9 The National Institute of Standards and Technology issued Federal
Information Processing Standards publications 38 and 64 covering
software development life-cycle documentation guidelines and
evaluation methodology. 

      ACCOUNTABILITY
-------------------------------------------------------- Chapter 3:1.6

Believing that strict accountability measures, such as requiring
providers to report vaccine usage, might prevent them from
participating, CDC initially minimized providers' accountability
requirements and delegated responsibility for them to the states.  In
May 1994, CDC advised the states that "although measures against
fraud and abuse are appropriate, the effect such measures will have
on provider participation must be considered."\10

CDC mandated only that the states require providers to complete three
enrollment documents.\11

CDC's initial plan was to use the providers' own estimates of their
vaccine needs as the basis for vaccine accountability.  We noted in
July 1994 that this plan was inadequate and that CDC lacked any
independent means of verifying state vaccine needs.  Even though
providers were already legally required to maintain data on all
immunizations and had been advised to collect similar data under ACIP
recommendations, CDC did not require the states to collect actual
usage information from the providers that received free vaccine.\12
Thus, we concluded in our earlier report that it would not be able to
detect fraud and waste.  Moreover, providers' enrollment remains low,
despite VFC's minimal accountability requirements. 

Reversing policy, on November 14, 1994, CDC gave the states 1 month
to develop comprehensive accountability plans for their supplies of
free vaccine.  These plans contain a variety of measures, including
plans in many states to compare providers' profiles and ordering
patterns to external databases such as immunization registries.  But
since no states have reported to CDC, it still cannot distinguish
between the number of children who have been immunized under VFC and
the number of doses of vaccine that have been distributed, nor can it
accurately assess vaccine waste. 

The major federal accountability requirement has been that providers
estimate the number of their patients who are eligible for VFC and
their vaccine needs.  However, most states report that providers
"greatly" or "somewhat" overestimate these numbers.  CDC has found
that several states relying on these estimates have projected vaccine
needs that exceed the total numbers of children in the appropriate
age ranges.  Therefore, CDC has dropped its plans to use such data as
a basis for accountability, engaging a contractor in February 1995 to
study alternative measures. 

In the absence of better accountability plans, CDC has no way to
ensure that VFC is reaching the target population, let alone pockets
of underimmunization.  Under CII, random-digit-dialing surveys of
immunization projects in various states and cities will provide data
on immunization rates by certain demographic criteria.  However, when
the results become available, they will neither identify specific
areas within these states and cities where children are at highest
risk of not being immunized nor distinguish between VFC's effect and
that of other, concurrent efforts to improve children's immunization. 
Further, their capacity to assess high-risk populations may be
compromised by the reliance on households with telephones as a
sampling frame. 

--------------------
\10 Centers for Disease Control and Prevention, Vaccines for Children
Operation Guide (Atlanta:  May 1994), p.  42. 

\11 Centers for Disease Control and Prevention, Vaccines For Children
Operations Guide, p.  22.  The three enrollment documents are the
provider's profile, the provider's enrollment form, and the patient
eligibility form. 

\12 Public Law 99-660, 100 Stat.  3774 (1986), 42 U.S.C.  sec. 
300aa-25; U.S.  Department of Health and Human Services, Public
Health Service, "Standards for Pediatric Immunization Practices,"
Morbidity and Mortality Weekly Report, 42:RR-5 (April 23, 1993), 3. 
Standard 9 states that "Providers use accurate and complete recording
procedures." Standard 14 suggests that "Providers conduct semi-annual
audits to assess immunization coverage and to review immunization
records in the patient population they serve."

      EVALUATION
-------------------------------------------------------- Chapter 3:1.7

As of May 1, 1995, CDC had released no plans for evaluating the VFC
program, and 31 of the states we interviewed in December 1994 had no
such plans.  The states that did generally acknowledged that they
were not intended to evaluate its effect (versus assess its
implementation) or could not distinguish VFC from other factors. 
Simple comparisons of preprogram and postprogram immunization rates
or proxy variables will not allow evaluators to attribute any changes
to VFC rather than to other simultaneous activity within the larger,
ongoing effort among the states to increase childhood immunization. 
Forty states reported initiating related programs at or near the time
when VFC began.  No direct effect could be expected in the states
that had universal purchase programs prior to VFC, since VFC
represents only a change in their source of financing for vaccine
purchases.\13

CDC officials reported that their draft VFC evaluation plans focused
on program implementation, which CDC has begun to examine through
periodic surveys of state immunization personnel. 

--------------------
\13 However, it is possible that these states will incorporate new
vaccines in their programs more quickly than they would have when
state funding was required. 

   INCREASING IMPLEMENTATION AND
   OPERATIONS BURDEN
---------------------------------------------------------- Chapter 3:2

In its haste to implement VFC by October 1, 1994, CDC intended to
complete some tasks as the implementation burden decreased once the
program had begun.  However, the burden is unlikely to decrease.  As
the program progresses to year 2, incomplete tasks from year 1 are
added to the current year's program operations, such as ongoing
program enrollment and accountability activities, and to the
subsequent year's implementation needs, such as the renewal of
vaccine and distribution contracts. 

Just as the failure to complete a task contributes to problems in
program implementation in any given year, these problems are
compounded over time, increasing the work of agency staff.  Moreover,
since implementation tasks are interdependent, those that remain
incomplete in one year may actually prohibit the completion of others
in subsequent years.  For example, without adequate accountability
mechanisms, critical data on vaccine use in fiscal year 1995 are
unavailable for negotiating contracts for vaccines and their
distribution in fiscal year 1996.  The absence of such information
similarly complicated negotiations with manufacturers in fiscal year
1994, as exemplified by the controversial limits incorporated in the
OPV contract. 

CDC is not able to ensure that VFC's problems in contracts, vaccine
ordering and distribution, provider enrollment and reimbursement,
accountability, and evaluation will be resolved before or within the
next fiscal year.  Some of the program's failings, such as low
enrollment among private providers, might improve over time, but
without better monitoring of VFC's implementation, CDC cannot
guarantee that the children who need VFC vaccine will get it, and it
is poorly prepared to ensure a safe transition or good coordination
between existing programs and VFC. 

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

We found ongoing problems in six of the seven areas of program
implementation we examined.  Although contract negotiation and
enrollment of public health providers are largely complete, the
enrollment of private providers appears to be low.  While HCFA
conducts a cost study, VFC policies governing provider fees remain
inconsistent with the law.  At least 15 jurisdictions had not begun
routine shipments of vaccine to private providers by March 1995. 
Moreover, VFC's automated order processing system was not developed
in conformance with federal guidelines and, consequently, supports
limited program functions and fails to meet important user
requirements.  CDC's accountability plans do not permit it to
distinguish the number of children immunized with VFC vaccine from
the number of doses of vaccine distributed and thus limit its
capacity to monitor vaccine waste and diversion.  Finally, evaluation
plans were not ready as late as May 1995. 

Collectively, these facts raise concerns about VFC's management and
its coordination with other immunization programs.  VFC's management,
split across HCFA, CDC, and the states, offers little assurance of a
smooth transition between VFC and other immunization programs.  For
example, while VFC operates in conjunction with Medicaid's
immunization efforts, the two programs have not been adequately
coordinated.  HCFA has therefore been unable to set criteria for
cut-off dates for vaccine reimbursement under Medicaid, and data on
Medicaid providers critical for developing VFC's provider-enrollment
goals are not available. 

PROMISING OPTIONS
============================================================ Chapter 4

Just as there are many barriers to the immunization of children at
high risk of not being immunized, so increases in their immunization
rates have been attributed to many efforts to overcome these
barriers.  Some of these efforts may entail smaller federal costs
than those anticipated for VFC and may be equally or more effective. 
The complex nature of underimmunization requires varied interventions
based on sound research.  Thus, it is important that limited
resources are targeted to the most important potential barriers and
populations at highest risk. 

CDC-funded studies describe two strategies that have demonstrable
promise for improving immunization rates.  One is to reduce missed
opportunities for immunization during children's regular contacts
with their health care providers.  This has been done by establishing
clinic audit and feedback systems and reminder and recall systems.\1
For example, immunization registries have received much attention;
they not only provide information on children's immunization status
but may also help monitor immunization, record children's adverse
reactions, and account for vaccine.\2 Another strategy is to
coordinate immunization services with large public programs such as
the Special Supplemental Food Program for Women, Infants, and
Children (WIC) and Aid to Families with Dependent Children (AFDC)
that cover children who are known to be at high risk of not being
immunized on time.  Some other interventions that have been suggested
include strengthening state, local, and clinic infrastructures,
improving parental education, offering incentives to states or
providers, and requiring that insurance cover immunization. 

--------------------
\1 See, for example, M.  Chaney, "Evaluation of Vaccination
Strategies in Public Clinics--Georgia, 1985-1993," Morbidity and
Mortality Weekly Report, 44:16 (1995), 323-25. 

\2 By tracking doses of vaccine administered, registries could also
help estimate vaccine waste and projected needs within the Medicaid
or VFC programs.  See National Vaccine Advisory Committee,
Subcommittee on Vaccination Registries, "Developing a National
Childhood Immunization Information System:  Registries, Reminders and
Recall," Washington, D.C., 1994. 

   REDUCING MISSED OPPORTUNITIES
---------------------------------------------------------- Chapter 4:1

Underimmunized children in major American cities have had many
contacts with health care providers without receiving indicated
vaccines.\3 The missed opportunities resulted from not administering
vaccines simultaneously, not compressing the vaccination schedule for
children known to be behind schedule, not knowing children's
immunization status, and following false contraindications.  Table
4.1 shows the immunization levels for 2-year-old children observed in
the four CDC-sponsored studies discussed in chapter 2 and projected
improvements in them that could be achieved by reducing such missed
opportunities. 

                               Table 4.1
                
                   Percentage of Actual and Potential
                Vaccination Coverage Among 24-Month-Old
                Children by Individual Vaccine Doses and
                          Study Site, 1991-92

                        Vaccine\a/              Potential\
Study site              dose            Actual           b  Difference
----------------------  ----------  ----------  ----------  ----------
Baltimore               DTP/DT/3           85%         93%          8%
                        DTP/DT/4            58          74          16
                        Polio/3             65          81          16
                        MMR/1               80          89           9
Los Angeles             DTP/DT/3            54          62           8
                        DTP/DT/4            26          34           8
                        Polio/3             34          50          16
                        MMR/1               39          48           9
Philadelphia            DTP/DT/3            82          85           3
                        DTP/DT/4            57          67          10
                        Polio/3             68          79          11
                        MMR/1               87          94           7
Rochester               DTP/DT/3            94          99           5
                        DTP/DT/4            75          96          21
                        Polio/3             80          95          15
                        MMR/1               90          96           6
----------------------------------------------------------------------
\a DTP/DT = diphtheria and tetanus toxoids and pertussis
vaccine/diphtheria and tetanus toxoids.  MMR = measles-mumps-rubella
vaccine. 

\b Assumes all missed opportunities to vaccinate had been eliminated. 

Source:  Morbidity and Mortality Weekly Report, 43:39 (October 7,
1994), 711. 

Noting the problem of missed opportunities, one CDC study reports
that, in Georgia clinics,

     "Providers often told the parents of young infants to bring the
     children back in 2 months, even after children had fallen 2 or 3
     weeks (or even months) behind.  Most clinics in Georgia were not
     using the minimal time intervals between doses unless a child
     started extremely late or was getting ready for school or day
     care.  Everybody else was automatically told to come back in 2
     months--more by habit than because of medical judgment."\4

Consequently, 90-percent on-time levels for children 12 months old
dropped to 50 percent or 60 percent for children 18 months old.  Many
children had not received their third dose of
diphtheria-tetanus-pertussis vaccine by 9 months and were
consequently ineligible for their fourth dose at 15 months.  The
assessment of immunization practices combined with feedback to
immunization providers and the development of reminder and recall
systems are two specific strategies that show some promise for
helping reduce missed opportunities. 

--------------------
\3 See, for example, A.  S.  Bates et al., "Risk Factors for
Underimmunization in Poor Urban Infants," Journal of the American
Medical Association, 272:14 (October 12, 1994), 1105-9, and J.  S. 
Gindler et al., "Successes and Failures in Vaccine Delivery: 
Evaluation of the Immunization Delivery System in Puerto Rico,"
Pediatrics, 91:2 (February 1993), 315-20. 

\4 Eugene Dini, "Assessment as a Motivational Tool," 26th National
Immunization Conference Proceedings (Atlanta:  Centers for Disease
Control and Prevention, March 1993), pp.  55-59. 

      IMMUNIZATION PRACTICE
      ASSESSMENT AND FEEDBACK
-------------------------------------------------------- Chapter 4:1.1

Routinely evaluating children's immunization dates as recorded in
clinic records has been coupled with feedback to health care staff
that includes estimates of coverage levels by site and by age, lists
of children missing immunizations, and reasons such as late starts,
dropouts, and poor documentation.  Depending on the prevalence of
particular reasons for missed immunizations, providers may then be
advised to consider postpartum appointments, reminder and recall
systems, or accelerated immunization schedules. 

CDC's Immunization Action Plan (IAP) grantees are required to use
this audit strategy, and CDC plans to support their efforts to apply
it in all public clinics, having developed and distributed software
for this purpose.  However, the 64 grantees and 24 urban areas are
visited only about once every 6 to 9 months by staff from CDC's
Program Operations Branch.  Potential extensions of this immunization
practice assessment and feedback technique would cover Community and
Migrant Health Centers under the Bureau of Primary Health Care,
managed care organizations, and private providers. 

When Georgia public health clinics piloted the strategy, the
percentage of children who missed opportunities for immunization
because they had failed to receive simultaneous immunizations fell
from more than 25 percent in 1986 to less than 5 percent in 1991. 
Simultaneously, the proportion of 2-year-old children who had
received four doses of DTP, three doses of OPV, and one dose of MMR
rose from about 35 percent to nearly 70 percent.  These changes
cannot be attributed with certainty to the assessment and feedback
activities, but a relationship is suggested.  It should be noted,
however, that the clinic assessments were "the most time-consuming
activity performed by the Georgia field staff," taking from 20 to 25
percent of the time for seven staff members.\5 Thus, careful
evaluation of the strategy's cost- effectiveness is warranted. 

--------------------
\5 Dini, p.  55. 

      REMINDER AND RECALL SYSTEMS
-------------------------------------------------------- Chapter 4:1.2

Reminder and recall systems prompt providers of immunization due
dates and recall parents when the dates are missed.  Such systems
focus on children as soon as they become eligible for immunization
and when they fall off schedule.  Whether manual or automatic, such
systems may send messages by telephone or mail.  They may be limited
to periodic review of particular providers' records or incorporated
in a comprehensive statewide immunization registry. 

Through a reminder and recall system attempted in public health
departments in 14 Georgia counties, 36 percent of the children
randomly assigned to receive a telephone reminder visited the health
department within 30 days.  Only 28 percent of the children whose
households were not assigned to be contacted visited the
department.\6 Thus, visiting increased modestly. 

Similar increases have been achieved by systems using letters,
postcards, personal telephone calls, and home visits, but costs for
materials and labor have precluded their use by some state and local
health departments and private practitioners.\7

Initial costs for automated dialing arrangements are high ($10,000
for the first year), but subsequent costs are lower.  These
arrangements may actually be more cost-effective than reminders
relayed by mail or personal calls because they require less labor. 
It should also be noted that the percentage of households
successfully contacted may vary significantly depending on
demographic characteristics.  For example, Hispanic and other ethnic
children had contact rates of only 35 percent and 42 percent in one
study.\8 Messages had their greatest effect for children who were
late for MMR, the third or fourth dose of DTP, or the third dose of
OPV (particularly important insofar as on-time immunization rates
appear to decrease with age).\9

--------------------
\6 Robert W.  Linkins et al., "A Randomized Trial of the
Effectiveness of Computer-Generated Telephone Messages in Increasing
Immunization Visits Among Preschool Children," Archives of Pediatric
and Adolescent Medicine, 148 (September 1994), 908-14. 

\7 E.  Byrne et al., "Infant Immunization Surveillance:  Cost vs. 
Effect:  A Prospective, Controlled Evaluation of a Large-scale
Program in Rhode Island," Journal of the American Medical
Association, 212 (1970), 770-73; T.  Quattlebaum, P.  Darden, and L. 
Sperry, "Effectiveness of Computer-Generated Appointment Reminders,"
Pediatrics, 88 (1991), 801-5. 

\8 Linkins et al., p.  911.  See also P.  Stehr-Green et al.,
"Evaluation of Telephoned Computer-Generated Reminders to Improve
Immunization Coverage at Inner-City Clinics," Public Health Reports,
108 (1993), 426-30. 

\9 F.  Cutts et al., "Monitoring Progress Toward U.S.  Preschool
Immunization Goals," Journal of the American Medical Association, 267
(1992), 1952-55. 

   LINKING IMMUNIZATION SERVICES
   TO WIC AND AFDC
---------------------------------------------------------- Chapter 4:2

WIC grants the states funds to help low-income pregnant women and
young children obtain food.  Pilot projects coordinating immunization
services with WIC have assessed a child's immunization record when
the mother visits the WIC clinic to obtain food vouchers, usually
every 2 months.  Among other WIC-based interventions, the mother's
schedule for receiving food vouchers may be made contingent on her
child's up-to-date immunization, with more frequent visits required
when the child is behind schedule.  Children who need immunization
may be referred either to their usual source of care or to an on-site
immunization clinic.  In interventions in New York City, making the
schedule for receiving vouchers contingent on immunization or
escorting the mother and child to a nearby immunization clinic
substantially increased immunization rates among WIC participants. 
More data are needed to carefully evaluate the relationship between
the voucher sanction and withdrawal from the WIC program. 

Nonetheless, WIC is especially well-suited to coordination with
immunization services because participants typically visit a program
site with some regularity and the program focuses largely on children
younger than those encompassed in AFDC, Medicaid, or even Head Start. 
More than 40 percent of the nation's preschool children participate
in WIC during their first year of life, although the figure varies
from state to state.  Moreover, surveys following the 1989-91 measles
epidemic found that between 29 and 63 percent of preschool children
with measles were enrolled in WIC.\10

It might also be possible to raise immunization rates by better
integrating immunization services in the AFDC, Medicaid, and Early
Periodic Screening, Diagnosis, and Treatment programs.  Ten states,
at their own initiative, now have waivers under AFDC to link
immunization requirements to the receipt of AFDC benefits.\11

As currently applied, this approach tends to rely on punitive
reductions in AFDC grants and generally holds only parents
accountable for immunization, including no sanctions for providers
who refer Medicaid patients to public clinics at higher rates than
privately insured patients.  Evaluations of this approach are still
in progress but early results appear to be promising. 

--------------------
\10 S.  Hutchins et al., "WIC Immunization Experience:  An
Appropriate Setting for Immunization Services," 27th National
Immunization Conference Proceedings (Atlanta:  Centers for Disease
Control and Prevention, 1994), pp.  149-52. 

\11 These states are Colorado, Delaware, Florida, Georgia, Indiana,
Maryland, Michigan, Mississippi, Montana, and South Carolina. 
However, South Carolina does not plan to exercise its waiver. 

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

Evidence suggests that various factors that lead to missed
opportunities to immunize children can be successfully addressed by
systems that remind providers that immunizations are due and recall
parents when appointments or vaccines have been missed.  Such
tracking systems can operate at the clinic level or as part of more
comprehensive immunization registries.  Similarly, missed
opportunities have been reduced when the records of immunization
clinics are audited and the results of these audits are made known to
clinic staff.  Finally, the states' integration of immunization
services into WIC and other programs that cover large segments of the
preschool population shows promise for raising timely immunization
coverage among children known to be at high risk of delayed
immunization. 

CONCLUSIONS, MATTERS FOR
CONSIDERATION, AND AGENCY COMMENTS
============================================================ Chapter 5

   CONCLUSIONS
---------------------------------------------------------- Chapter 5:1

CDC officials have noted that

     "The experience of immunization programs worldwide has
     identified three factors critical to success:  (1) establishment
     of measurable objectives that are continuously evaluated; (2)
     quality control of program performance, and (3) research to
     solve operational problems."\1

Inasmuch as studies of past outbreaks suggest that disease is
greatest in areas of high population density where substantial
numbers of preschool children are not immunized on time, it seems
reasonable to identify, emphasize, and monitor immunization coverage
in these areas, which is masked when coverage goals and measures are
not broken down by age, risk, and residence. 

While it appears that the greatest threat of disease is currently
presented by concentrations of underimmunized children rather than
widespread underimmunization in the general population, both CII's
and VFC's goals emphasize raising immunization rates in the
population at large.  Even if VFC were fully implemented, its
accountability and evaluation mechanisms could not track its effect
where the need for timely immunization is greatest.  As we noted in
chapter 2, CDC's own analyses of geographic patterns in measles cases
suggest that it may be possible to enhance disease prevention efforts
by targeting special efforts to such areas. 

Major studies of underimmunized children indicate that free vaccine
was generally available to them before VFC.  Evidence is insufficient
to conclude that vaccine cost has been the major barrier for the
parents of these children.  Thus, even a fully functional VFC is not
likely to prevent outbreaks of vaccine- preventable disease.  Data on
underimmunized children in major metropolitan areas indicate that
supplementary action independent of making vaccine free will be
required and that efforts other than VFC may hold greater promise. 

CDC has not collected important data for measuring VFC's
implementation and supporting its evaluation.  Specifically, CDC
lacks figures on the proportions of enrolled public health providers,
private providers likely to immunize children, and Medicaid providers
of pediatric care.  It does not know the proportions of eligible
children served by these providers or what provider enrollment levels
are necessary to meet and maintain its goal of immunizing 90 percent
of the nation's children with most antigens by 1996.  Moreover, this
overall goal does not account for the potential for the outbreak of
specific diseases where underimmunization is greatest. 

Some of CDC's implementation decisions may undermine its goals.  For
example, CDC does not require VFC providers to report the vaccination
of particular children; this is inconsistent with CDC's
acknowledgment, under CII, of the importance of tracking systems. 
Without knowing what doses providers actually administer or to whom,
CDC will not be able to sort between the numbers of children
immunized with VFC vaccine and the amount of vaccine distributed. 
The states' use of Medicaid and other data for accountability
purposes (such as vaccine-usage reports, doses-administered reports,
and immunization registry data) could serve as a foundation for basic
tracking and evaluation. 

Missed opportunities are more closely linked to underimmunization
than vaccine cost or parental attitudes.  Promising alternatives for
increasing immunization rates include reviewing providers' records
and providing feedback, using reminder and recall systems more
broadly (perhaps in conjunction with registries), and incorporating
voucher incentives for up-to-date immunization of children covered by
WIC.  All these strategies are operating in many places.  They share
an emphasis on reducing missed opportunities for immunizing children
when they make contact with their medical providers.  They would
require further examination before implementing them broadly but seem
promising for wider application. 

--------------------
\1 F.  T.  Cutts et al., "Monitoring Progress Toward U.S.  Preschool
Immunization Goals," Journal of the American Medical Association,
267:14 (April 8, 1992), 1952-55). 

   MATTERS FOR CONSIDERATION
---------------------------------------------------------- Chapter 5:2

The Congress may want to consider refocusing VFC's goal from the
improvement of general immunization rates to the achievement of
higher immunization rates in pockets of need, where conditions are
ripe for disease outbreaks among underimmunized children.  A program
with immunization targeted to pockets of need should be more
cost-effective than the current approach.  In conjunction,
enrollment, accountability, automation, and evaluation efforts need
to be adjusted to focus on children who are at greatest risk for
delayed immunization.  For example, reminder and recall or tracking
systems might help identify and reach them. 

   AGENCY COMMENTS AND OUR
   RESPONSE
---------------------------------------------------------- Chapter 5:3

We shared a draft of this report with responsible officials of the
Department of Health and Human Services on June 10, 1995, and
received oral comments from them on June 13, 1995.  (We also orally
summarized our findings in an exit conference with HHS officials on
May 2, 1995, and received oral comments.) The officials stated that
they did not agree with our conclusions and believed that our views
were not balanced.  However, the comments they provided were directed
primarily to tone and technical matters.  We have incorporated these
comments in the final report where appropriate. 

1994 ADVISORY COMMITTEE ON
IMMUNIZATION PRACTICES
IMMUNIZATION SCHEDULE
=========================================================== Appendix I

                                                                  4-
                                                                  6
                        Birt  1-                  6-   12-        year
Vaccine                 h     2    2    4    6    18   15    15   s
----------------------  ----  ---  ---  ---  ---  ---  ----  ---  ----
DTP\a                              x    x    x               x    x

OPV\b                              x    x    x                    x

MMR\c                                                  x          x

Hib conjugate\d
----------------------------------------------------------------------
HbOC/PRPT\e                        x    x    x         x

PRP-OMP\f                          x    x              x

Hep B\g
----------------------------------------------------------------------
Option 1                x     x                   x

Option 2                      x         x         x
----------------------------------------------------------------------
\a Diphtheria and tetanus toxoids and pertussis vaccine. 

\b Oral polio vaccine. 

\c Measles-mumps-rubella. 

\d Haemophilus influenza type B conjugate. 

\e Haemophilus influenza oligosaccharide conjugate/polyribose
phosphate tetanus. 

\f Polyribose phosphate-outer membrane protein. 

\g Hepatitis B. 

Note:  Since this schedule was issued, ACIP, the American Academy of
Pediatrics, and the American Academy of Family Physicians have agreed
on a harmonized immunization schedule, which is available in CDC, The
Race to Vaccinate:  The Year 2000 and Beyond, 29th National
Immunization Conference (Washington, D.C.:  U.S.  Department of
Health and Human Services, Public Health Service, 1995). 

MAJOR CONTRIBUTORS TO THIS REPORT
========================================================== Appendix II

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

Sushil K.  Sharma, Assistant Director
Betty A.  Ward-Zukerman, Assignment Manager
R.  E.  Canjar, Project Manager
Penny Pickett, Communications Analyst

   ACCOUNTING AND INFORMATION
   MANAGEMENT DIVISION
-------------------------------------------------------- Appendix II:2

William D.  Hadesty, Assistant Director
Christie M.  Motley, Assistant Director

   OFFICE OF GENERAL COUNSEL
-------------------------------------------------------- Appendix II:3

George Bogart, Senior Attorney

*** End of document. ***
```