Immunization Registries

**Progress Report**

**December 4, 2000**

***Executive summary:** Since approval of the report "Development of
Community- and State-Based Immunization Registries" by the National
Vaccine Advisory Committee (NVAC) in January, 1999, important progress
has been made toward all four primary objectives identified in the
report. In the area of privacy, confidentiality, and security, a
document outlining minimum specifications has been approved and
distributed. Important support for registries has been manifested by
numerous professional organizations and agreement has been reached on
key technical standards. Provider recruitment is proceeding, but not as
rapidly as desired. Financial sustainability has not been achieved.
Support continues through Federal Section 317 Immunization Grant funds
and the prospect exists for support through Medicaid. Additional Federal
support through the operational funds of the Vaccines For Children would
provide a critical and stable base of financing. In addition to VFC
support, a 5-year \$60 million/year grant program would help support
further development and initial implementation of registries. Finally,
concerted efforts should be directed to getting financial support for
immunization registries from the private sector (health
plans/insurers).*

**Introduction:** On July 23, 1997, President Bill Clinton said: *"I'm
directing Secretary Shalala to start working with the states on an
integrated immunization registry system....we have to do it and do it
right."* In response to this mandate, the National Vaccine Advisory
Committee (NVAC) led an Initiative on Immunization Registries with
support from the National Vaccine Program Office (NVPO) and the National
Immunization Program (NIP) of the Centers for Disease Control and
Prevention (CDC). Following a series of public meetings and focus
groups, NVAC approved the report "Development of Community- and
State-Based Immunization Registries" on January 12, 1999. The report
identified four objectives and recommendations and action steps for
each.

Immunization registries are "confidential, computerized information
systems that contain information about immunizations and children." The
goal is to "establish a nationwide network of community/state
population-based registries that are capable of sharing information
while maintaining privacy and confidentiality." The purpose of this
report is to highlight progress toward achieving that goal in the past
20 months, describe major remaining issues, and make recommendations for
future action. The progress report is organized according to the four
primary objectives identified by NVAC and the action steps NVAC
recommended.

Three recent actions transcend these specific objectives. The first is
the release of the Healthy People 2010 objectives in January 2000.
Objective 14-26 is to "increase the proportion of children \[\<6 years
of age\] who participate in fully operational population-based
immunization registries" to 95% by 2010. The second is the convening of
two highly successful conferences on immunization registries
co-sponsored by CDC, All Kids Count (AKC), and host state health
departments. More than 360 persons attended the 1999 conference in St.
Paul MN and almost 400 attended the 2000 conference in Newport RI. CDC
has committed to support annual registry conferences in the future.

The third major action was the release, in June 2000, of the Institute
of Medicine (IOM) report \"Calling the Shots: Immunization Finance
Policy and Practices." The report characterized the immunization program
as a \"national treasure that is too often taken for granted.\" It also
described the importance of reminder/recall, assessment, etc., as major
components of successful immunization programs. These functions are all
facilitated by use of immunization registries. The IOM committee stated
that "Once fully operational, registries may allow communities to target
their outreach and other interventions more successfully, as well as
achieve significant savings in other surveillance
programs....immunization registries offer one of the most useful
instruments for assessing the population-specific effectiveness of
health and medical care programs."

## Specific objectives

# Ensure appropriate protections of privacy and confidentiality for individuals and security for information included in the registry.

# 

# Action steps: 

# Develop specifications for minimum protections

# Develop and disseminate a DHHS-approved policy statement on needed protections to guide actions until legislation is enacted

# Assure each registry has a written policy and protocols

# Continue monitoring of privacy and confidentiality developments at state and local levels

**Progress:** In February 2000, NVAC approved a document outlining
minimum specifications for privacy, confidentiality, and security. This
document, an update of a chapter approved by NVAC in 1997, addresses
confidentiality policies, user agreements, parent notification, parental
consent, use of immunization data, access to and disclosure of registry
information, liability penalties for unauthorized disclosures, data
retention and disposal, and security of data. The chapter was developed
under the leadership of CDC in close consultation with privacy experts
and is consistent with HIPAA legislation and proposed regulations. It
has been widely disseminated and is available on the NIP/CDC registry
web site.

CDC has made strong recommendations to its project sites to develop
written policies and procedures consistent with these minimum
specifications. Information is currently incomplete as to the degree of
compliance, but no reports have been submitted to CDC or DHHS describing
instances in which confidentiality has been breached.

**Major remaining issues:** Interstate exchange of information while
assuring appropriate protection of confidentiality within individual
states has not yet been achieved. Not all issues regarding sharing
information between different registries have been resolved (e.g.,
differing approaches to consent). A pilot project is under development
between the states of Washington and Oregon to test this exchange. In
addition, a Memorandum of Understanding on data exchange between North
Carolina and Tennessee is now being extended to other states through the
Southern Governors Association.

**Recommendations:**

-   Continue efforts to ensure that all registries implement policies
    and procedures that meet minimum specifications for protecting
    privacy and confidentiality

-   Monitor implementation of minimum specifications

-   Further explore and develop privacy and confidentiality guidelines
    for interstate exchange of information

-   Continue to ensure that privacy and confidentiality specifications
    are consistent with evolving HIPAA regulations

1.  **Ensure participation of all immunization providers and
    recipients.**

**Action steps:**

-   Develop organizational/institutional support

-   Develop educational materials for parents/patients and providers

-   Work with vendors to make registry use as simple as possible

-   Facilitate integration of registry functions into existing
    information systems

**Progress:** Many organizations have passed resolutions or made
statements endorsing immunization registries, including the American
Academy of Pediatrics, American Association of Health Plans, American
Medical Association, American Osteopathic Association, American Public
Health Association, American School Health Association, Association of
State and Territorial Health Officials, Informed Parents Against Vaccine
Associated Paralytic Polio, National Association of County and City
Health Officials, National Association of Pediatric Nurse Associates and
Practitioners, National Association of School Nurses, National Medical
Association, National School Boards Association, and the U.S. Secretary
of Education.

Educational materials have been developed at national, state, and local
levels for parents and providers. A toolkit to help registry
coordinators work with private providers has been developed by a
workgroup led by AKC and will shortly be distributed to CDC immunization
projects and other registries.

Intensive efforts to recruit private providers are underway at the local
level but progress is not as rapid as desired. Providing information
back to providers and focusing on simplicity are important tools in
recruitment. Efforts are underway at national and state levels to
establish methods that can consistently and accurately "de-duplicate"
records, increase the timeliness and ease of reporting data, and provide
a standard "language" so state and local registries can exchange
information.

CDC is identifying a number of "sentinel" or model registries. These
registries will be asked to provide quarterly updates of vaccine
coverage levels for their populations and may be asked to examine
specific questions on vaccine use or uptake. Successful demonstrations
of the practical uses of registry data and the timeliness of their
assessments will be important demonstrations of their need and value.

An important action to help create demand by parents and providers has
been an increased emphasis on data quality to ensure that information
from disparate sources is consolidated into a single complete record of
each child\'s immunizations.

The CDC June 2000 National Registry Report indicates that registries are
under development or in operation in all states of the country as well
as the District of Columbia and Puerto Rico. 47 jurisdictions reported
information on current functionality of population-based immunization
registries. These included 27 states, DC, PR, and 18 city or regional
registries. In these areas, 40.7% of children 0-6 years of age are
currently enrolled in registries (Figure 1). In the same areas, 58.6% of
public providers and 19.6% of private providers are participating in
registries (Figure 2).

With respect to integration, 76.6% of registries report they are sharing
information with vital statistics systems, 70.2% with Community/Migrant
Health Centers, 53.1% with public clinic billing systems, 53.1% with
hospitals, 46.8% with WIC, 46.8% with private clinic billing systems,
40.4% with managed care organizations, 38.3% with Medicaid Management
Information Systems, 34.0% with schools, and 31.9% with Indian Health
Service facilities. A major effort is currently underway in New York
City to link the Citywide Immunization Registry with the lead poisoning
program information system. CDC, the Health Resources and Services
Administration (HRSA), and All Kids Count are working on integration of
other systems including newborn metabolic and hearing screening.

**Major remaining issues:** Continued recruitment of providers and
parents.

**Recommendations:**

-   Intensify efforts with major payers and plans to go beyond mere
    endorsement and obtain commitment to participation

-   Continue dissemination of information about the utility of
    registries

-   Continue demonstration of registries' decision support functions at
    the provider level

-   Additional research on the impact of registry use on workflow in
    providers' offices

-   Additional research on the impact of registry use on
    parents/families

2.  **Ensure appropriate functioning of registries**

**Action steps:**

-   Form a Technical Working Group to reach agreement on standard
    vocabularies and protocols for data transfer

-   Develop benchmarks for accreditation/certification

-   Provide ongoing quality assurance monitoring

-   CDC should monitor implementation of registries and provide
    technical assistance

**Progress:** A major step forward was realized with the development of
implementation guidelines for exchanging immunization information using
Health Level 7 (HL7) protocols. These guidelines were developed through
leadership from CDC working in collaboration with six registries, Kaiser
Permanente, Indian Health Service, and AKC. Adherence to these
guidelines will enable ready exchange of information in a standard
format between registries.

Even before the 1999 NVAC report was issued, CDC had established a
mechanism for acquiring immunization registry software using Section 317
Direct Assistance immunization funding. Contracts were awarded to four
vendors of commercially available Immunization Information Systems
Software whose core systems meet the minimum functional requirements
established by CDC. This approach makes it easy for grantees to obtain
software meeting (and exceeding) minimum specifications.

CDC has modified the grant guidance for the 317 Immunization Grant
Program to require that applicants include objectives and action steps
for each of the 13 functional standards for registries.

The Advisory Committee on Immunization Practices (ACIP) has endorsed
precise definitions as to what constitutes an acceptable minimum/maximum
age and interval for administering a particular vaccine. CDC used these
definitions to develop algorithms for their use. This will free registry
developers from having to develop their own algorithms and make it
easier for registries to agree on what constitutes adequate
immunization. By assuring consistent definitions of adequate
immunization (e.g., defining adequate measles immunization as a dose
administered not more than 7 days before the first birthday), the
algorithms will prevent unnecessary revaccinations.

A Technical Working Group (TWG) has been formed with representatives
from informatics and standards-making organizations, health care
software vendors, field registry managers, managed care organizations,
state/local health departments, and staffed by CDC. The TWG has reviewed
and endorsed the 13 Immunization Registry Functional Standards developed
by CDC that are being used as criteria for evaluating registries.
Discussion continues on what evaluation tools should be used, and what
approach should be taken to certification.

As recommended by NVAC, a Committee on Immunization Registry Standards
and Electronic Transactions (CIRSET) has been formed and receives staff
support from CDC. It includes immunization registry developers who are
actively developing data exchange capability with other registries and
providers and who have agreed to follow the HL7 implementation guide.
CIRSET intends to establish common implementation policies and provide
technical assistance to other developers. In addition, CIRSET intends to
approach vendors about building the HL7 specification into their
information systems. To assist with CIRSET\'s efforts, CDC is developing
a public domain HL7 parser for intended distribution to registry
developers in 2002.

The Vaccine Identification Standardization Initiative (VISI) is working
to develop standardized unique identifiers for each vaccine
manufacturer, formulation, and lot. This information will be bar-coded
and make it much easier to enter specific vaccine information into
registries.

CDC carries out an annual survey of immunization registries to monitor
the extent of development, enrollment of children and providers, and
functionality. Some preliminary results from the 2000 Report are
provided in the preceding section. It should be kept in mind that the
data are self-reported.

An American Immunization Registry Association (AIRA) has been formed to
foster immunization registry development across the country through
provision of technical expertise, research, education, and training;
provide a forum for information exchange and innovation; promote use of
universal registry standards; and build partnerships among public and
private registry networks, vendors, providers, and official agencies.

CDC holds monthly conference calls with state and city registry managers
and representatives from the Health Care Financing Administration
(HCFA), HRSA, U.S. Dept. of Agriculture (USDA), Association of State and
Territorial Health Officials (ASTHO), All Kids Count (AKC), Every Child
by Two (ECBT), and Information for Public Health Officials (INPHO) to
improve communication and discuss contemporary issues.

There is increasing evidence of registries being used to improve
immunization practice and carry out important public health and
assessment functions. A few examples follow:

-   [*Improving coverage*:]{.underline} In Phoenix AZ, recorded
    immunization rates for 700 low-income children in five related child
    care centers and two charter schools hovered around 45%. Acquisition
    of a laptop computer that connected to the Arizona Statewide
    Immunization Information System (ASIIS) led to a rapid doubling of
    coverage to 90% through a combinationof better records and
    additional immunizations.

-   [*Vaccine safety*:]{.underline} In Arkansas, the state registry
    identified 51 children in 1999 who had received vaccine from lots
    that had expired and helped to recall them.

-   [*Increasing timeliness of immunization*:]{.underline}
    Implementation of the reminder/recall function in the San Bernardino
    County (California) registry led to a decline in average age for
    receiving MMR vaccine (recommended at 12-15 months) from 20 months
    in 1994 to 13 months in 1999. This means that, on average, children
    are protected 7 months earlier now than they were before the
    registry went into operation.

-   [*Helping providers reach coverage goals*:]{.underline}
    HealthPartners is a large Minnesota HMO with patients receiving care
    either in staff model clinics or affiliated clinics. Before
    implementing a registry in the staff model clinics in 1997, coverage
    rates for 4 DTP, 3 polio, 1 MMR, and 1 Hib were essentially the same
    in the two populations (88.2% in staff model and 85.1% in affiliated
    clinics). One year after implementation of the registry, rates in
    the staff model clinic rose to 95.7% but remained essentially
    unchanged (83.9%) in the affiliated clinics, which were not
    participating in the registry. HealthPartners includes adults in the
    registry and, as a result of using the registry, reports
    pneumococcal vaccination coverage of 85% in patients
    [\>]{.underline}65 years of age.

-   [*Studying effectiveness and efficiency*:]{.underline} In Oklahoma,
    the registry was used to monitor the impact of changing
    recommendations on use of polio vaccines. Registry data showed that
    changing recommendations for the first two doses of polio vaccine
    from oral vaccine to injectable (requiring an additional injection
    of infants at 2 and 4 months of age) was [not]{.underline}
    associated with a decrease in coverage for polio (or for other
    vaccines). The registry also was used to monitor patterns of
    administration of a birth dose of hepatitis B vaccine associated
    with changing recommendations.

-   [*Keeping managed care records up to date*:]{.underline} In Oregon,
    health plans and Medicaid managed care immunization rates have
    increased as much as 32% and 36% respectively as a result of having
    more accurate, up-to-date immunization data.

**Major remaining issues:** HL7 standards and the ACIP algorithm are not
yet fully implemented, certification standards and procedures have not
yet been finalized, and many registries are not yet fully making use of
the information contained for programmatic activities. Additionally,
some technical issues remain to be worked out to facilitate exchange of
information between registries.

**Recommendations:**

-   Continue advocacy and dissemination of the HL7 standards and the
    ACIP algorithm (perhaps making them required conditions for
    continued 317 funding)

-   Finalize and implement approach to certification of registries

-   Disseminate information about how registries are being used to
    improve immunization coverage and immunization practices (this also
    serves as an important means of recruiting providers)

-   Continue to provide technical assistance

-   Assure quality of data in registries

-   Resolve remaining issues on exchange of information between
    registries

3.  **Ensure sustainable funding for registries**

**Action steps:**

-   Complete studies of registry costs (both start-up and maintenance)
    and cost offsets

-   Develop and introduce a legislative proposal for a 5-year grant
    program

-   Meet with stakeholders to recommend approaches for long-term support

-   Continue to monitor costs and benefits of registries

**Progress:** Both CDC and AKC have completed cost studies of
registries; the AKC study has been published in the American Journal of
Preventive Medicine. Based on these studies it can be estimated that it
will cost approximately \$125 million/year to operate a nationwide
network of population-based immunization registries covering children
from birth through the sixth birthday. The AKC study also estimated that
nationwide use of registries would offset approximately \$114
million/year now being spent within the health care system. More than
half of this represents current efforts to retrieve records, assess
adequacy of immunization and transcribe information to provide records
for school entry or change of provider. Other savings would accrue from
avoiding duplicate immunization and not having to perform the National
Immunization Survey. AKC also obtained information from 43 states
indicating that their school systems currently spend more than \$168
million/year to review immunization records, a task that would be done
automatically using registries. Thus, an investment of \$125
million/year would offset more than \$280 million currently being spent
by the health care and school systems. Further studies are needed to
fully characterize both the costs and the savings associated with use of
registries.

CDC ascertained the current sources of funding for immunization
registries. It found that 42% of registry costs are currently coming
from Immunization Grant (317) funds. States are providing 32% of the
costs, and a variety of sources (including local governments,
foundations, private sources) provide the remainder.

On May 1, 2000, a legislative briefing on Immunization Registries was
held, co-sponsored by All Kids Count, Every Child By Two, and several
major health and education organizations. Congressional co-sponsors
included 8 Senators and 3 Representatives.

**Major remaining issues:** While current cost estimates provide a good
foundation for understanding current and future financing needs,
further, independent, studies will be needed to reflect new
developments. Based on the current level of 317 funding and the
proportion of registry costs that are provided from 317, it can be
estimated that approximately \$50 million/year is currently being spent
on registries. Comparing that to the \$125 million/year needed to
maintain registries, it is apparent there is a shortfall of
approximately \$75 million/year.

Ongoing discussions with a range of stakeholders have identified a
variety of possible funding sources. From the federal level these could
include increases in support through Section 317, the 5-year grant
program recommended by NVAC, use of some of the vaccine excise tax,
Vaccines for Children (VFC) operational funds, HCFA/Medicaid, or support
from other programs (e.g., newborn metabolic screening). Non-federal
sources could include state or local governments (including school
systems), insurers and health plans, foundations, or fee-for-service.
Each will be considered briefly below.

Immunization grant (317) -- overall funding for this program has been
declining (Figure 3) and the amount of 317 support for immunization
registries has also been declining -- from a peak of approximately \$50
million in 1995 to approximately \$21 million/year in 1998 and 1999
(Figure 4). For FY 2001, states requested approximately \$75 million
more for program operations than was in the budget request. Even if this
amount were appropriated, it would mean only approximately \$10 million
more for registries.

New 5 year grant program -- no legislation has been drafted.

Vaccine excise tax -- although this would seem to be an equitable way to
spread the cost of registries across the private and public sectors, it
seems highly unlikely such a proposal could win approval currently.

VFC operational funds -- approximately 40% of children less than 7 years
of age are uninsured or covered by public insurance only and thereby VFC
eligible. An unknown additional number of children are VFC eligible
because they are underinsured and seeking care in Federally Qualified
Health Centers. Nationwide, approximately 40% of childhood vaccines are
purchased through VFC. Given the tremendous benefits to VFC of
registries, it seems appropriate for VFC operational funds to be used to
help develop and operate registries. Such support seems totally
consistent with the VFC legislation, which requires creation of an
accurate and complete immunization history on a child, accurate
assessment of immunization needs, prevention of unnecessary doses of
vaccine, and estimating coverage rates. This could provide a critical
and stable base of financial support

HCFA/Medicaid -- approximately 26% of children less than 7 years of age
are covered by public insurance. HCFA has chosen immunization coverage
as one of its GPRA indicators. Because registries can both help to
improve coverage and document the coverage achieved, it is logical for
Medicaid to support immunization registries. An important step has been
taken with the July 7, 2000, letter from the Director of Medicaid
announcing availability of federal matching funds for registry costs
associated with Medicaid eligible children. Matching would be at the 90%
or 75% level for registries residing in, and part of, a state\'s
Medicaid Management Information System (MMIS). For registries that exist
independent of the state's MMIS (probably the majority), the match would
be at the 50% level.

Other federal programs -- discussions are ongoing with programs such as
newborn metabolic screening and newborn auditory screening about ways of
integrating and linking systems. However, the level of funding of these
programs does not suggest they could make a significant contribution to
immunization registry operations.

State/local governments -- state governments currently contribute 32% of
registry costs and local governments 1%. While much of the benefit of
registries will accrue to state and local governments (by reducing
school system expenditures for assessing immunization records) and some
increases might be possible, patterns of state and local expenditures do
not indicate a great likelihood that significant increases will be
forthcoming.

Insurers/health plans -- in some areas insurers and health plans are
currently providing support for registries. Since 60% of children are
covered by private insurance and since both insurers and plans derive
considerable benefits from registries (e.g., healthier children, HEDIS
reports), it seems logical that insurers and health plans should
uniformly provide support for registries. To date this avenue has not
been pursued vigorously at the national level.

Foundations -- several foundations have contributed to registries. For
example, the Robert Wood Johnson Foundation has provided approximately
\$20 million over the past 6 years to support registries (through the
All Kids Count program). Other foundations have contributed smaller
amounts. However, these do not appear viable as long-term mechanisms for
support.

Fee-for-service -- this approach has been tested in the state of
Washington but was not successful.

Ongoing discussions with stakeholders indicate that most seem to favor a
diversity of funding sources. The 1999 NVAC Report "Strategies to
Sustain Success in Childhood Immunizations" stated that: "A stable
funding mechanism for immunization registries needs to be developed that
combines resources from the federal government, state and local
governments, and the private sector."

At the National Immunization Conference in July 2000, Secretary Donna
Shalala said:

"You can be assured that before I leave office, any authority I have
through the Medicaid program or the Vaccines for Children programs to
support these registries, any decision I can make, will be done before I
leave in January. This is the critical piece that we need to put in
place."

With continuing 317 support and the addition of HCFA and VFC support
there will be a clear government commitment to support operation of
registries for publicly supported immunizations. Now it is time for the
private sector to provide similar support for children cared for in the
private sector.

**Recommendations:**

-   Continue and increase support for registries through the 317 program

-   Widely promote use of Medicaid funds for registries and monitor
    implementation; explore possible use of CHIP/S-CHIP administrative
    funds

-   Obtain approval to use VFC operational funds for registries

-   Intensify discussions with insurers/health plans urging them to
    provide support for registries (i.e., \$5/year/child covered)

-   Develop a 5-year \$60 million/year grant program to support further
    development and initial operation of registries (this could be
    handled through a targeted increase in 317 funding). This is
    justified by the cost-effectiveness of registries

-   Continue to update and expand studies of costs and benefits of
    registries.

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