DEPARTMENT OF HEALTH & HUMAN SERVICES 
Health Care Financing Administration 
Center for Medicaid and State Operations 
7500 Security Boulevard 
Baltimore, MD 21244-1850 
July 
6, 2000 
Dear State Medicaid Director: 
This letter provides guidance on the development of immunization registries as a component of 
the Medicaid Management Information System (MMIS) to ensure all children receive their 
immunizations on time to live happy, healthy lives.  HCFA strongly supports State efforts to 
ensure that children and adults are immunized based on the standards and recommendations 
of the Advisory Committee on Immunization Practices. Immunization registries can be a 
valuable tool in tracking immunization rates. 
Under certain conditions, enhanced Federal financial participation (FFP) is available at 90 
percent for the design, development, and installation, and 75 percent FFP for the operation of 
State MMIS systems.  These enhanced rates are available for immunization registries that are 
components of the State MMIS to the extent that the registry serves Medicaid program 
beneficiaries and meets the specifications set forth in the attachments to this letter.  In States 
where the Immunization Registry is developed, owned, and operated by a public health or 
other non-Medicaid agency, FFP is available at 50 percent for States costs associated with 
Medicaid eligible children. 
BACKGROUND 
In response to a request by the U.S. Senate Appropriations Committee in 1998, the Institute 
of Medicine of the National Academy of Sciences recently completed a study, ACalling the 
Shots: Immunization Finance Policies and Practices.@ The Study Committee cited much 
progress with immunization efforts and describes the overall approach as being highly 
decentralized and shaped by local circumstances, resources, and needs as well as by national 
goals and policies. 
In spite of record levels of immunization achieved across the country since 1993, certain 
problems have persisted with the immunization delivery system:  !	 The need to sustain and document high levels of immunization 
coverage for a growing number of vaccines delivered within 
multiple health settings; 
Page 2 - State Medicaid Director 
!	 Persistent racial and ethnic disparities in childhood levels of 
immunization coverage; 
!	 Mortality and morbidity from preventable infectious diseases; 
and 

	 Gaps and inconsistencies from State to State in the 
coordination,  support, and documentation of immunization 
efforts. 
In recent years, the country has seen immunization rates increase as more and more children are 
receiving their scheduled immunizations on time. This news is encouraging, but low 
immunization rates, particularly among Medicaid-eligible children, remain.  Over 60 percent of 
all children who do not receive timely and complete immunizations come from poor areas, and 
many of them are Medicaid beneficiaries. Most health providers have difficulty tracking the 
immunization history of children for a variety of reasons, such as frequent moves and lack of a 
consistent medical home. One highly effective way to address this problem is through the 
development, installation, and use of immunization registries. 
WHAT IS AN IMMUNIZATION REGISTRY? 
An immunization registry is a confidential, population-based, computerized information system 
that contains information about immunizations and children. Information in the registry can be 
used to determine individual vaccine needs and remind parents when their child is due for a 
vaccine.  Providers can access the registry to determine which vaccines their patients need and 
bring them back to the clinic or office when immunizations are due. 
Because confidentiality of Medicaid data is an important issue, we would like to remind you of 
discussion on this topic contained in our October 22, 1998, State Medicaid Director letter, 
AFacilitating Collaborations for Data Sharing between State Medicaid and Health Agencies.@ In 
the Model Medicaid Data Sharing Agreement attached to that letter and co-signed by the  Administrators of HCFA and HRSA, as well as the Director of the Centers for Disease Control 
and Prevention, we reference Section 1902 (a)(7) of the Social Security Act (as amended) 
which provides for safeguards in this area. In addition, regulations at 42 CFR 431.302 are also 
cited and specify the purposes directly related to State plan administration. 
MEDICAID=S ROLE 
In recent months, we have been working closely with the Centers for Disease Control and 
Prevention, as well as the Health Resources and Services Administration, to develop an initiative 
Page 3- State Medicaid Director 
to promote State use of the Medicaid MMIS to support immunization reporting efforts. We 
believe it should be an integral part of the Medicaid program. 
Enclosed is a template for a Planning Advance Planning Document (APD) designed to expedite 
Federal approval for FFP to support immunization registries. We have also enclosed an APD 
Guidance Document (which provides detail on the Registry APD process as well as the 
functional requirements), and a matrix highlighting the mandatory functional requirements 
required for registries to receive Medicaid funds. States are required to allocate costs among 
Federal and State programs according to the principles contained in OMB Circular A-87 in 
accordance with relative benefits received. 
If your staff has any questions regarding the enclosed documentation, please have them contact 
your MMIS representative in your Regional Office, or Jason Goldwater on my staff at (410) 
786-0476. 
By supporting immunization registries, whether within the MMIS, or developed and maintained 
by other State agencies (for which 50 percent FFP is available to the extent that the activity can 
be allocated to the Medicaid program), we can make great strides in improving the health status 
of our beneficiaries. 
I am sure you will agree with me that immunization registries warrant serious attention and your 
support.  I look forward to working with you on this endeavor. 
Sincerely,  Timothy M. Westmoreland 
Enclosures 
Page 4 - State Medicaid Director 
cc: 

All HCFA Regional Administrators

All HCFA Associate Regional Administrators

for Medicaid and State Operations

Lee Partridge

Director, Health Policy Unit

American Public Human Services Association

Joy Wilson

Director, Health Committee

National Conference of State Legislatures

Matt Salo

Director of Health Legislation

National Governors Association

Walter A. Orenstein, M.D.

Director, National Immunization Program

Centers for Disease Control and Prevention

Claude E. Fox, M.D., M.P.H.

Administrator

Health Resources and Services Administration 
 Claire Hannan

Association of State and Territorial Health Officials

Bill Watson

All Kids Count

Amy Pisani

Every Child by Two

Paula Soper

American Immunization Registry Association

Page 5 - State Medicaid Director

Laurel Woods

Association of Immunization Managers

Director 

Partnership for Prevention
 U.S. Department of 
Health and Human Services 
7500 Security Boulevard 
Health Care Financing 
Baltimore, MD 21244 
Administration (HCFA) 
Medicaid 
Action Transmittal 
Action Transmittal #: DSS-CMSO-AT-00-001  Issuance Date: July 6, 2000 
TO:  State Agencies Administering 
or Supervising the Administration of Title XIX of the Social 
Security Act, State Departments of Public Health and other 
interested parties administering or supervising Statewide 
Immunization programs.  SUBJECT:  Automation of an Immunization Registry 
KEY WORDS:  Statewide Automated Immunization Registry System (SAIRS) 
ORIGINATORS: 	 Center for Medicaid and State Operations 
Data and Systems Group 
Division of State Systems 
RELATED REFERENCES:	 Title XIX of the Social Security Act, 1903 (a)(3)(A)(i) and (7) 
of the Social Security Act , 42 CFR Part 433, Subpart A, 
433.10, 433.15, 433.35, Public Health 42 CFR, Subpart 
C, and , 432.50 (b)(3), Public Welfare 45 CFR, Part 74, Part 
95, Subparts F and G, (references OMB Circular A-87 Cost 
Principles for State, Local and Indian Tribal Governments. 
PURPOSE:  This Action Transmittal (AT) provides system guidance and identifies the system 
requirements for States pursuing the development of a 
Statewide Automated Immunization Registry System under Title 
XIX for Mechanized Claims Processing and Information 
Retrieval Systems.  It is intended to establish policy and 
supplement the intent of CFR 42 in the development of a 
Medicaid Management Information System (MMIS) as 
interpreted through regulation, and to provide technical 
assistance to States in the design, development and 
implementation of an Immunization Registry. 
CONTENT:  This Action Transmittal contains five major sections: 
  Part I contains a background section which discusses 
the authorizing legislation, and the implementing regulations, 
which support an Immunization Registry. (Page 1) 
  Part II includes more specific agency policies related to 
Immunization Registry planning, development and 
implementation. (Page 2) 
  Part III contains detailed information on allowable 
costs, exemptions, the Planning Advance Planning 
Document (APD) and cost allocation methodologies. 
(Page 4)    Part IV includes information on the degree of 
functionality for the Immunization Registry and its interfaces. 
(Page 10) 
	 Part V contains the functional requirements for the 
Immunization Registry and general program guidance. 
(Page 12) 
SUPERSEDED

MATERIAL:  None

EFFECTIVE DATE:  Immediately

INQUIRIES TO:
 HCFA Regional Administrators  Timothy M. Westmoreland 
Director 
Center for Medicaid and State Operations 
Attachment  Part I  Background 
Effective statewide-automated capability to support the administration of services offered through 
immunization registries is essential to enable improvements in Medicaid program administration and 
service delivery.  1996, President Clinton urged that 90 percent of all 12 to 23-month-old children be 
fully up-to-date for their recommended immunizations by the turn of the century.  While the nation is 
making considerable progress towards reaching that goal new approaches are needed to overcome 
deficiencies in current immunization information handling practices.  Current challenges include: 
(1) Incomplete records due to fragmentation of health care delivery. This is often seen in the 
movement of at-risk children from public providers to Medicaid managed care or in the 
movement of children on or off the Medicaid rolls, or simply when children receive immunizations 
from different providers. Such movement may hinder the ability of providers and parents to assess 
immunization needs as well as the ability of third-party payers to validate the quality of services their 
customers receive. 
(2) Antiquated methods resulting in large and cumbersome files of paper records. Such files may not 
allow rapid access to immunization histories, even in one physical location. 
(3) Errors or difficulties in assessing immunization needs due to the increasing complexity and 
continuously improving immunization schedule. 
To sustain high coverage rates for future generations, current efforts should be aimed at permanently 

resolving these deficiencies. Immunization registries or electronic immunization information systems can 

meet this need. A stable infrastructure based on electronic systems (immunization registries) would help 

a State Medicaid Agency by providing an accurate count of the number of Medicaid beneficiaries, from 

the age of

0-18, that are being vaccinated. The immunization information would be an accessible and integral 

component of patient data, which could then be utilized for quality assessment measures (i.e. HEDIS), 

amongst other things. Additionally, this would also take the form of an assessment tool to rapidly and 

continually monitor immunization coverage rates and identify special needs that may require a 

concentration of resources.

Funding 
The applicable regulation for the Title XIX program is contained in 42 CFR Part 433 at 433.15 
Subpart.A. It provides for Federal financial participation (FFP) in State expenditures for Statewide 
planning, design, development and installation (DDI) for mechanized claims processing and information 
retrieval systems, namely Medicaid Management Information Systems (MMIS). FFP is available at the  90 percent rate for DDI [pursuant to Section 1903(a)(3)(A)(i) and 42 CFR 432.50(b)(3)] and FFP is 
available at the 75 percent rate for the continued operation of such systems approved by HCFA. 
(Section 1903(a)(3)(B); 42 CFR 432.50(b)(2).)  Additionally, funding for all other activities for the 
proper and efficient administration of the State plan are funded at a 50 percent rate (section 1903(a)(7) 
and 45 CFR 433.15 9a)(7), and to build interfaces from other data systems which: 
	 meet the requirements imposed by regulation promulgated pursuant to Section 1903 (Section 4753 
of Public Law 105-33) and 1903 (a)(3) of  15 A. 
  meet the functional requirements identified in this guidance document; and 
	 to the extent practicable, are capable of interfacing with State data collection systems that collect 
information regarding immunization histories of children. 
Whether or not enhanced match is available for the development, design, installation and operation of an 
automated immunization registry depends upon an analysis of the registrys relationship to the MMIS, as 
explained in this Action Transmittal. 
Part II  Immunization Registry Policies 
This section addresses more specific agency policies related to Immunization Registry planning, 
development and implementation. 
A.  Eligibility for Enhanced Funding under Title XIX 
Medicaid is authorized as a part of Title XIX of the Social Security Act, and provides funds to all 
States, and the District of Columbia. Insular areas are not included in Title XIX, and Puerto Rico is 
subject to a financial cap in the Social Security Act, which precludes it from claiming additional funds. 
The 50 States and the District of Columbia are the only jurisdictions eligible to receive enhanced funding 
under these provisions. 
Title XIX funds may be passed through by States to entities with which they have agreements to 
perform some or all of the functions of the State Title XIX agency.  Expenditures for such purposes are 
eligible for reimbursement under Title XIX as if they were expended by the State agency itself.  The 
claims are submitted to HCFA only by the State, not by any entity with which the State has an 
agreement.  Typically, these entities are Indian Tribes and private, non-profit social service agencies. 
Expenditures under Title XIX may be claimed for the eligible State agency and for entities with which it 
has agreements, so long as the claims are for otherwise allowable costs.  B. Statewide System 
A Statewide system must operate uniformly as a single system (including the application software) 
throughout the State and must encompass all political subdivisions that administer programs provided 
under Title XIX. 
In some cases, a Statewide system may interface with another system(s) to perform required functions 
(e.g., a State Bureau of Vital Statistics to provide birth data).  The APD must include a narrative to 
describe how the Immunization Registry will link to other systems to meet the functionality required. 
C.	 Efficient, Economical and Effective Administration of Title XIX State 
Plans 
In consideration of demonstrated economic benefits, a State may propose an alternate design to that 
which is described in this Action Transmittal. By clearly documenting the potential savings, the State 
may propose a design which links an Immunization Registry type system existing in a large urban area to 
a new Statewide system.  Based on our review of the documentation, which should be included in the 
States Implementation Advance Planning Document (APD), HCFA will determine if the alternative 
design meets the efficient, effective and economical requirements of the Title XIX regulations. 
D. Use of Equipment 
Equipment may only be funded with Title XIX funds if it is for full time use by State agency employees 
responsible for providing Title XIX services offered by the designated State agency. Tribal employees, 
volunteers, and contract or private employees that replace or supplement designated State agencys 
employees for the provision of these services are, for the purpose of funding the cost of equipment 
installed for their use, considered State agency employees. 
E. Use of System/Application 
Within legal parameters, the State agency may allow non-State agency staff (e.g., service providers, 
non-State agency staff who provide State agency services) to have access to and utilize the statewide 
application. The application may not be modified to meet the unique needs of such users. Expenditures 
for any additional functions, processes, reports, data elements or requirements must be allocated to and 
supported by the non-State agency user. 
As with any system access, the State should take necessary precautions to comply with the safeguarding 
of data and confidentiality provisions addressed elsewhere in this transmittal. Use agreements with any 
third parties are encouraged at the States option. Use of the system for purposes other than those  related to the Title XIX program should comply with applicable State and Federal Law. 
F.  System Reviews  Certification 
Regional office staff will conduct a certification review to validate that a States SAIRS meets minimal 
requirements for approval. The purpose for this certification process is to assure that all of the functional 
requirements have been met, according to the terms of the States approved APD. 
Part III  Allowable Costs, Exemptions, Planning Advance Planning Document 
and Cost Allocation 
This section contains detailed information on allowable costs (at both the enhanced and regular matching 
rates) and additional guidance in the areas of exemptions, minimum requirements for a Planning 
Advance Planning Document and cost allocation. (An overview of the minimum requirements for the 
planning APD is in Appendix A.) 
A.  Allowable Costs 
In order to ascertain whether or not an enhanced match can be applied to an immunization registry, a 
determination must be made as to whether the registry could be part of the MMIS.  Section 1903 (a)(3) 
of the Act refers to these systems as including an information retrieval element. The regulation 
defining the systems further states that they are to be used to retrieve and produce service utilization 
and management information required by the Medicaid single State agency and Federal Government for 
program administration... (42 C.F.R.  433.111 (b)).  If the immunization Registry, is developed as 
part of the MMIS, then the system is an information retrieval mechanism within the definition of the 
MMIS. 
HCFA has determined that Federal financial support of these registries is in the best interest of the 
Medicaid program.  Therefore, the analysis is whether under each of the following scenarios below the 
Immunization Registry, as proposed, would reside in, and be a part of, a States MMIS, thereby 
qualifying for the enhanced match provided in 1903 (a)(3) of the Act. If the registry exists independent 
of the States MMIS, HCFA assumed that the registry is an administrative cost, the Medicaid match 
would be made pursuant to  1903 (a)(7) and matched at 50%. 
In addition, there must be an allocation of costs between Medicaid and non-Medicaid sources in order 
to maintain consistency with past HCFA and Departmental policies.  OMB Circular A-87, Cost 
Principles for State, Local, and Indian Tribal Governments, sets forth certain requirements regarding 
allocation. The Circular states that, to be claimed under a Federal grant program, a cost must be 
allowable and among the factors determining whether it is allowable are whether it is  necessary and  reasonable and whether it is allocable (OMB Circular A-87 at 9-10). The Circular further states 
that a cost is allocable to a particular cost objective if the goods or services involved are chargeable or 
assignable to such cost objective in accordance with relative benefits received. (Id. at 11). 
a.	 Example 1 - The Immunization Registry is built as part of the States current MMIS 
reporting system.  Ownership and operation of the registry is by the State Medicaid 
Agency. The registry would include both Medicaid and non-Medicaid beneficiaries. Based 
on 1903(a)(3)(A)(I) of the Act, an enhanced rate of 90% is permissible for the costs 
allocable to Medicaid for the design, development, and installation of a registry under this 
scenario.  Under  1903(a)(3)(B) of the Act, the application of the 75% enhanced rate is 
permissible for the costs allocable to Medicaid for the operation and maintenance of a 
registry under this scenario. 
b.	 Example 2 -The Immunization Registry is built and owned by the States Department of 
Public Health, or a Department similar in kind, and is completely separate from the States 
MMIS reporting system. The registry includes both Medicaid and non-Medicaid 
beneficiaries.  The outlay of funds in this case is deemed necessary for the proper and 
efficient administration of the State plan. Section 1903(a)(7) would allow Federal financial 
participation at the 50% match for the design, development and installation as well as the 
continued operation of the Registry. 
c.	 Example 3 -the Immunization Registry is built and owned by the States Department of 
Public Health, or a Department similar in kind, and includes only non-Medicaid 
beneficiaries.  An interface is constructed to connect the registry with the States MMIS 
reporting system so as to include Medicaid beneficiaries.  Additional development within the 
Registry would be needed to increase its capacity to include the additional Medicaid 
population, as well as to add functionality needed to support the Medicaid program.  To the 
extent that the interface is outside of the MMIS, a 50% match for its design, development 
and installation and continued operation would be appropriate based on  1903(a)(7) of the 
Act. Additionally, development on the Immunization Registry to increase its capacity in 
addition to its operation would also be eligible for the 50% match. 
d.	 Example 4 - the Immunization Registry may be located anywhere (other than the States 
MMIS reporting system) and includes both Medicaid and non-Medicaid beneficiaries. As 
outlined above and based on  1903(a)(7) of the Act, a 50% match for the design, 
development and installation and the continued operation of the Registry is appropriate. 
B.  Exemptions  There are cases where a State has already designed, developed and installed an Immunization Registry, 
and funding has already been approved by HCFA at either the enhanced rate or the regular Federal 
match rate. In these instances, States will not have to submit an Advance Planning Document to 
maintain their funding.  However, if at any time a State decides to add additional functionality, or change 
the design and/or specifications of its existing registry, the State must request funding through HCFA 
(according to 45 CRF, Part 95).  The Immunization Registry must meet the functional specifications 
contained in Part V. 
C.  Confidentiality 
Federal statutes and regulations allow, and in many instances require, designated State agencies to 
disclose confidential information to other State Agencies for the purpose of administering other Federal 
programs.  To the extent that these registries are maintained as part of the Medicaid program, the 
information collected would be confidential information subject to the confidentiality provisions of 42 
C.F.R. Part 431, Subpart F.  Under current policy, such information could not be disclosed for non-
beneficiaries, because such disclosure would not be consistent with plan administration as set forth in 
42 C.F.R. 431.302. In addition, Section 1902(a)(7) of the Act requires that the State restrict the use 
or disclosure of information concerning applicants and recipients to purposes directly connected with the 
administration of the medical assistance plan. 
D. Planning Advance Planning Document (APD) 
The Planning APD is a brief document prepared and submitted to HCFA prior to initiating Planning 
Phase activities. The purpose is not to provide needs and plans in detail, but to develop a high-level 
management statement of vision, needs, objectives, plans, and estimated costs. The focus is on 
describing how planning will be accomplished and demonstrating that the State has established a plan 
that is reasonable for the level of effort of the project. Planning APDs that meet the standards for 
approval detailed below will be approved within 60 days.  The Planning APD has four sections: 
Statement of Need, Project Management Plan, Planning Project Budget and Estimate of Total Project 
Cost.  1.  Statement of Need 
This section of the Planning APD should set forth the States information and services, vision, 
including the scope and the objectives of the planned information system and its interrelationships 
with other systems (if known). In addition, the needs statement should define the system 
requirements in terms of problems and needs listed.  The State must address five distinct issues 
relating to the need for an Immunization Registry at an enhanced rate. Those issues can be broken 
down into the following: 
	 Statement of Vision  The State must demonstrate that the development of an immunization 
registry would reduce the overall incidence of vaccine-preventable disease by giving providers 
and the State a high-quality, confidential, flexible and expendable tool.  It would ensure age 
appropriate immunization for all children with the most efficient expenditure of the program and 
its resources. 
	 System interrelationships  The State must demonstrate how the immunization registry would 
interact with data systems so as to would populate the registry on a continual cycle. It must also 
demonstrate that interaction between the registry and the Medicaid program that would allow 
for the entire population of Medicaid eligible children to be included. Appendix A gives an 
indication of the types of interrelationships imagined. If those in the State differ, an explanation 
of those differences must be included. 
	 Problems of deficiencies in existing system - The State must identify whether a registry currently 
exists and any deficiencies in that system that may warrant the procurement of a new system. 
	 New or changed program requirements  The functional requirements detailed in Part IV of the 
Guidance Document must be addressed in the development of a registry.  Any differences must 
be explained. 
	 Opportunities for economy or efficiency  If a State can demonstrate that their registry is 
compliant with the functional requirements of Part IV, then HCFA will determine that the 
registry has sufficient opportunities for both economy and efficiency.  2. Project Management Plan 
The project management plan summarizes how the State will plan to implement its Immunization 
Registry.  The States planning project organization are briefly described. At this point in the 
project, all that is required is that the State identify key players in the planning phase, such as the 
project manager and other key planning staff by name and title. This information can be depicted in 
an organization chart. The Project Management Plan for planning describes how and when the 
activities for the Planning Phase will be conducted and schedules milestones for completion of key 
events. The State must identify the following components of a project management plan: 
	 Planning Project Organization  The State must detail those individuals, from both the State and 
a potential contractor(s) that would be responsible for the development and implementation of 
the registry. Furthermore, the responsibilities and relationships must also be highlighted, with an 
organizational chart and an accompanying narrative. 
	 Planning activities, products and deliverables  The State must detail, in one page or less, the 
planning activities mentioned in the APD, the products that would come from the development 
and implementation phases, and a schedule of deliverables they intend on adhering to. 
	 Commitment to conduct analysis and JAD (Joint Application Design Sessions with Users)  
Each State must check off whether they intend to do any of the following types of analysis: 
1.	 Requirements Analyses  the resources and time needed to develop and implement an 
immunization registry. 
2.	 Feasibility study  an analysis done by the State in order to determine the necessity of 
developing a registry 
3.	 Alternatives analysis  examining the potentiality of developing alternate systems, our 
utilizing previously implemented technology within the status quo to accomplish the goals of 
a registry. 
4.	 Cost/benefit analysis  analyzing the initial and long-term costs during the development 
and implementation of the registry and comparing them to the cost benefits a registry would 
provide over a certain period of time. 
5.	 JAD (joint application design sessions with users)  whether a State will participate with 
users of a registry in its initial design phase. 
6.	 Functional specification  a detailed analysis of the functionality of the registry being 
developed and whether it is consistent with HCFAs functional requirements. 
7.	 Systems design  an analysis of how the registry would be developed, what technology 
would be employed, how it would be populated and how it would serve the Medicaid 
community. 
	 Re-Inventing the Wheel  a State must explain if they have given any consideration to 
transferring an existing module that would have the functionality of a registry. If it is deemed that  such a transfer would be non-beneficial, than an explanation justifying the new procurement 
must be included. 
	 State/contractor needs  The State should summarize, in one page or less, the resource needs 
for the development and implementation phases. 
	 Planning project procurement activities and schedule  In one page or less, the State must 
provide detail regarding the acquisition of the registry technology in addition to its development 
and implementation target date. 
	 Requirements and evaluation plan  A State must also describe its requirements for acquiring 
and developing a registry, in addition to a comprehensive evaluation plan to ensure that all 
functional requirements have been met. 
  Restrictions on work  If any exist, an explanation must be attached 
	 Testing plans of interfaces  A description of testing plans and methodologies regarding 
interfaces to the MMIS, as well as other secondary systems (i.e., EPSDT, WIC, etc.), needs to 
be added, as well as a summary of a testing schedule. 
3. Planning Project Budget 
This section describes the resource needs that funding supports during the Planning Phase that may 
be requested by the State.  These needs may relate to State and contractor staff costs, computer 
time, hardware and commercially available software, travel space, supplies, telephones, 
photocopying and so forth.  This section of the APD also provides the budget and the cost 
allocation to be used during the Planning Phase. States must address costs in a planning APD by 
categories, cost elements and amounts. 
a.  Anticipated FFP 
States must include information on the Federal Financial Participation (FFP) that they anticipate 
based upon the scenario that is most appropriate (see above, Allowable Costs). 
b.  Anticipated State Costs 
A State must include documentation that anticipates all costs that would be included in both the 
development and implementation of the registry, as well as a breakdown of projected costs by 
fiscal quarter and summarized by fiscal year. 
4.  Total Project Cost  The total cost of the immunization registry project must be included, and contain the State and 
Federal cost distributions. 
D. Cost Allocation 
A State must include in is planning APD a proposed methodology for allocating costs when the registry 
includes programs other than those carried out by Title XIX. This section gives general guidance in 
developing and applying this cost allocation methodology. 
A.  Immunization Registry Planning, Development and Installation 
States use a range of factors when developing a cost allocation methodology for a system project. 
Often, factors considered in cost allocation methodologies take different forms such as: analyzing 
system data elements; evaluating the specific functions to be programmed into the system; examining 
the populations to be served; projecting the level of effort in the design or programming activity and 
examining equipment utilization statistics measured on past projects with a similar size and scope. 
Since there is no preferred or best method, it is the States responsibility to develop a methodology 
using factors that they believe accurately reflects Federal and State program shares to appropriately 
and equitably allocate project costs, and to describe this methodology as part of the APD submitted 
for approval. 
Regardless of what factors are considered in a States methodology, the following guidance shall 
apply: 
1.	 If a factor exclusively benefits the programs funded under Title XIX, then the cost may be 
directly charged in full to Title XIX, with a 90% enhanced match expected. 
2.  If a factor is necessary for and primarily benefits the programs under Title XIX: 
a.	 And without further modification it benefits Medicaid programs (e.g., EPSDT), the cost may 
be charged in full to Title XIX. 
3.	 If a factor supports but does not exclusively or primarily benefit the programs under Title XIX, 
the cost must be allocated among all benefiting programs.  4.	 If a factor exclusively benefits any other single program, the cost must be direct-charged in full 
to that program at the appropriate FFP rate. 
B.  Immunization Registry Equipment 
Equipment acquired solely to support the activities of contract staff administering the Immunization 
Registry under the approved State plan may be charged to Title XIX. Equipment which is acquired 
to support other individuals or programs must either be direct-charged to the other agency or 
program, or allocated among all appropriate funding sources, dependent upon whether the 
equipment is used partially for the program under Title XIX. If equipment costs are to be partially 
allocated to Title XIX based on the fact that its use is shared among various programs, the State 
must propose a cost allocation methodology that accurately reflects its proper usage. 
C.  Central Data Processing Facilities 
In States where the agency acquires resources from a central data processing (CDP) facility, costs 
at the applicable matching rate must be charged in accordance with a HCFA approved cost 
allocation plan, normally based on the percentage of use by each agency utilizing the equipment. 
Equipment acquired for, or dedicated solely to, the operation and support of the Immunization 
Registry, consistent with the cost allocation principles outlined above, may be charged to Title XIX 
at the applicable FFP rate. 
Part IV  Degree of Functionality and Interfaces 
A. Degree of Functionality 
At a minimum, a States immunization registry must include the functionality described in Part V. 
Additional functionality, beyond what is defined in this guidance document, may be funded at the 
enhanced rate if the State can demonstrate that it will provide more efficient, economical and effective 
administration of an immunization program administered under Title XIX. Further, to be eligible for 
enhanced funding, the added feature may not duplicate functionality included in an existing system to 
which an interface is required. The justification and request to fund additional functionality at the 
enhanced rate must be included and approved in a States APD 
In order for HCFA to provide funding for an immunization registry, the planning APD must address two 
basic categories:    Core Attributes 
  Interface Requirements 
Both the core attributes and the interface requirements represent mandatory elements of an 
Immunization Registry. Some optional attributes have been added which a State may want to 
implement. Those optional features would be funded at the appropriate enhanced rate. An overview of 
the minimum functional requirements is in Appendix B. 
B. Interfaces 
The interfaces are critical to the overall effectiveness of an Immunization Registry. Its functionality 
would be hindered and ineffective if an interface did not exist between the Immunization Registry and a 
States Medicaid Management Information System (MMIS). This becomes apparent when such a 
registry is outside the domain of a Medicaid Department. An interface becomes essential in populating 
the registry with Medicaid beneficiaries as part of a States total population. Enhanced Title XIX 
funding may not be used to design, develop, modify or install other systems, nor is FFP available to 
develop functionality in an Immunization Registry when it duplicates functionality in other State systems 
for which an interface is required. For example, Title XIX eligibility must be determined through an 
existing Title XIX system. 
Funding for the optional interfaces is contingent on the overall cost effectiveness of the States design 
and the appropriate use of automation. For interfaces to entities that may operate several independent 
systems (e.g., public health clinics, health information systems) that State may develop a standard 
interface for the exchange of information. To the extent that such an interface is cost effective, the 
Medicaid part of it may be funded with enhanced funds. As with the limits on duplicative functionality, 
HCFA will not fund the development of multiple interfaces to common entities. For example, an 
Immunization Registry, which proposes multiple interfaces to public health clinics, will not be cost 
effective. Development of a single, comprehensive Immunization Registry interface that can 
accommodate the necessary exchange of data between the Immunization Registry and multiple entities 
would be acceptable and eligible for enhanced funding.  Part V: 
STATEWIDE AUTOMATED IMMUNIZATION REGISTRY SYSTEM 
PROGRAM/SYSTEM FUNCTIONS AND GUIDANCE 
A. Core Requirements 
Functions with an asterisk (*) are those that have been determined to be critical functions in meeting the 
minimum requirements of an automated Immunization Registry and should be met as part of the 
Medicaid Management Information System (MMIS) or through an automated interface.  An underlined 
may is an optional function that may be added and for which enhanced funding would be approved. 
1. Identifiable Information 
This function consists of information used to identify Medicaid-eligible children, demographic and 
vaccine-related information. 
A.  Medicaid Information* 
1.	 Medicaid Identifier* - The automated Immunization Registry must contain fields that can 
accommodate the childs Medicaid Identification number. 
2.	 Demographic Information* - The automated Immunization Registry must contain fields for the 
Childs first, last and middle names, birth date, sex, birth State/county, race/ethnicity and a 
guardians first, last and middle names.  Additionally, optional fields may be added from the 
Health Level-7 (HL-7) Code Set. 
3.	 Eligibility Information  The automated Immunization Registry may contain fields for time 
periods of Medicaid eligibility. 
4.	 Primary Provider/Medical Home  The automated Immunization Registry may contain fields that 
identify the Primary Care Provider/Medical Home for a Medicaid child. 
B.  Vaccination Information* 
1.	 Vaccination Information* - The automated Immunization Registry must contain fields for the 
type of vaccinations given and date of administration. 
2.	 Identify Provider*  To the extent possible, the automated Immunization Registry must identify 
the provider who administers a specific vaccination to a child.  3.	 Lot Information  The automated Immunization Registry may contain fields for a vaccination 
manufacturer and lot number. 
2. Case Management 
This function entails the enrollment of Medicaid children within the automated Immunization Registry, the 
types of functionality needed to support this population, and the management of delivery of the services 
provided by this automated support. 
A.  Enrollment* 
1.	 Enroll children at birth* - The automated Immunization Registry must establish a registry record 
for children no more than 6 weeks after birth or six weeks after they have otherwise been 
entered into the state's information management system(s) and maintain them within the system 
until they reach the age of 18. At that time, in accordance with State and local statutes and 
laws, the childs records may be expunged from the Immunization Registry.  Additionally, the 
Registry must identify the following: 
	 Adoptions; record information about adoptive 
services, including the adoptive parents information within the parameter of State law. 
  Deaths; record information about a Medicaid childs death before the age of 18. 
2.	 Maintain Individuals in the system for life  The system may maintain the individuals in the 
automated Immunization Registry until date of death. 
3.	 Record and Track visits of family members/household  The automated Immunization Registry 
may record and track visits of all family members/household. 
B.  Case Review/Evaluation* 
1.	 Contraindications/Exemptions* - The automated Immunization Registry must contain 
information on contradications and personal and/or philosophical exemptions. 
2.	 Reminder/Recall* - The automated Immunization Registry must generate an alert for guardians 
of Medicaid children as to the need for a series of vaccinations. Such information would be 
garnered from the immunization history of each child. This level of functionality would require 
that the name and address fields on the immunization record be completed. 
3.  Provider Access* - To the extent possible, the automated Immunization Registry must be  accessible by all providers in their place of practice.  The Registry must enable providers access 
to vaccination histories at the time of a scheduled encounter to determine the vaccinations 
needed. 
4.	 Adverse Event - The automated Immunization Registry may enable vaccine-associated adverse 
event reporting. 
C.  Monitoring Service* 
1.	 Needs Assessments* - The automated Immunization Registry must automatically determine the 
immunization(s) needed, in compliance with current recommendations from the Centers for 
Disease Control and Prevention, when an individual presents for a vaccination. 
2.	 Coverage/Community-Based Assessments* - The automated Immunization Registry must be 
capable of automating and managing community-based coverage assessments. The registry must 
have an automated function to measure immunization coverage (% of children age-
appropriately immunized) as of a given date for an individual providers practice, for the 
registrys entire catchment area, and for subgroups within a practice of the catchment area (e.g., 
children of a certain age). Age-appropriate should be defined according to current CDC 
recommendations implemented in the registrys algorithm. 
3.	 Surveillance of Reportable Diseases - The automated Immunization Registry may allow for 
surveillance of vaccine-preventable diseases. 
3. Resource Management 
This function supports the maintenance of monitoring of information on Medicaid children within the 
automated Immunization Registry 
A.  Provider Support* 
1.	 Submission of Information* - The automated Immunization Registry must have the ability to 
receive and process immunization information within one month of a vaccine administration. 
2.	 Flexibility* - The automated Immunization Registry must be flexible enough to add/delete 
vaccines as new vaccinations are added to the recommended schedule and others are removed. 
3.	 Data Requirements* - The automated Immunization Registry must have the capability to use the 
HL-7 defined code set for exchanging information. 
4.  GIS Analysis - The Immunization Registry may enable analysis through Geographic Information  Systems (GIS). 
5.	 Platforms for Non-Immunization Programs  The Immunization Registry may have a computer 
platform for non-immunization programs and/or systems. 
B.  Resource Support* 
1.	 Consolidation of Information* - The automated Immunization Registry must consolidate 
immunization records from multiple sources.  Such functionality would also include de-
duplication and quality checks. 
2.	 Data Backup and Recovery*- The automated Immunization Registry must be backed up 
regularly and backup media must be stored in a separate location. 
3.	 Inventory Reporting  The automated Immunization Registry may allow for automated vaccine 
inventory reporting. 
4.	 Vaccine Inventory  The automated Immunization Registry may manage vaccine inventories and 
generates reports on management and wastage. 
B.  Interfaces 
1.  REQUIRED INTERFACES* 
	 If an immunization registry is developed as part of a States MMIS, then it must 
interface with a Statewide system that, at a minimum, exchanges data on a weekly basis. To 
the extent that such a Statewide system exists, it must integrate the entire population of 
children from age 0 to 18 that can be immunized along with all Medicaid children.  Ideally, 
the interface would represent real-time, on-line data exchange. 
	 If the registry is built outside of a States MMIS, then an interface that, at a minimum, 
would exchange data on a weekly basis, must be constructed to link the MMIS with the 
automated Immunization Registry. This must be done to fully populate the registry with 
Medicaid children in order to provide immunization rates.  Ideally, the interface would 
represent real-time, on-line data exchange. 
2. OPTIONAL INTERFACES 
	 Additionally, to the extent possible, the State Registry may provide for interfaces with 
other systems within the State, such as:  a.  Child Welfare (SACWIS)

b.  Women, Infants and Children (WIC)

c.  Early Periodic Screening, Diagnosis and Treatment (EPSDT) Program

d.  Bureau of Vital and Health Statistics

e.  Childrens Health Insurance Program (S-CHIP)

f.  Public Health Clinics

g.  Health Information Systems (HIS)

h.  Vaccine Management System (VACMAN) (CDC)

i.  Other
 PPLLAANNNNIINNGG AAPPDD CCHHEECCKKLLIISSTT 
Immunization Registries (Medicaid) 
The Planning APD is a very brief document (6 -10 pages) prepared and submitted prior to initiating Planning Phase activities.  It is used to secure Federal 
financial participation (FFP) for the State. It is a plan to plan. The purpose is not to provide needs and plans in detail but to develop a high-level 
management statement of vision, needs, objectives, plans, and estimated costs. The focus is on describing how planning will be accomplished and 
demonstrating that the State has established a plan that is reasonable for the level of effort of the project. Planning APDs that meet the standards for 
approval shown in the following two pages will be approved within 60 days. The Planning APD has four sections: 1. Statement of Need 2. Project 
anagement Plan for planning 3. Planning project budget, and 4. Estimated of total project costs. 
Section  Content  Description of Minimum Requirements 
Statement of  Reduce incidence of vaccine-preventable disease by 
Need    Statement of Vision  giving providers and the State a high-quality, 
confidential, flexible and expendable tool. It ensures 
This section of the Planning  age-appropriate immunization for all children with the 
APD should set forth the  most efficient expenditure of program, resources. 
State's information and 
rvices "vision,"1 including 
the scope and objectives of    Yes    No 
the planned information 
system and its 
interrelationships with other    System  Include a diagram of the system interrelationships 
systems (if known). In 
addition, the needs statement  interrelationships 
should define the system    Problems or  Does an immunization registry already exist in your 
requirements in terms of 
problems and needs listed i n  deficiencies in existing  State? 
the next column.  system    Yes    No 
  New or changed  See attached CDC Minimum criteria. Explain any 
program requirements  differences. 
1 "Vision" means the State planners' view of future program needs and the systems architecture necessary to support those needs.    Opportunities for  HCFA will assume the immunization registry has 
economy or efficiency  sufficient opportunities for both economy and efficiency 
provided that the CDC minimum criteria are addressed. 
  Planning project 
Project  organization (State  Provide descriptive one page chart and one page of 
Management Plan  and contractor)   accompanying narrative. 
people, 
The Project Management  responsibilities and 
Plan summarizes how the  relationships 
State will plan. 
  Planning activities,  Briefly summarize in one page or less. 
The State's planning project  products and 
organization is briefly 
described. At this point in the  deliverables 
project, all that is required is 
that the State identify key 
players in the planning phase,  Requirements analysis    Yes   
such as the project manager  No 
and other key planning staff 
by name and title. This    Commitment to  Feasibility study    Yes   
information can be depicted  conduct analyses and  No 
in an organization chart. 
The Project Management  JAD sessions  Alternatives analysis    Yes   
Plan for planning describes  No 
how and when the activities 
for the Planning Phase will be  Cost/benefit analysis    Yes   
conducted and schedules  No 
milestones for completion of 
key events.  JAD (joint application design 
sessions with users)    Yes   
No 
Functional specification    Yes   
No 
Systems design    Yes   
No 
  Re-inventing the Wheel  What consideration has been given to transferring an 
existing module? Explain. 
  State/contractor needs  Briefly summarize in one page or less. 
  Planning project 
procurement activities  Briefly summarize in one page or less. 
and schedule 
  Requirements and  Briefly summarize in one page or less. 
evaluation plan 
  Restrictions on work?    None    If any, 
explain 
  Testing plans of  Describe plans and provide summary of testing 
interfaces  schedule.  Section  Content  Description of Minimum Requirements 
Planning Project    By categories, cost  Show cost allocation among users 
Budget  elements and amounts 
Anticipated FFP (90%, 75% and 50%) 
This section succinctly 
describes in narrative form the  Anticipated State costs 
resource needs for which 
funding support during the 
Planning Phase may be  Projected costs by fiscal quarter + summarized by fiscal 
requested by the State. 
year, including planning project total, and program totals. 
These needs may relate to 
State and contractor staff 
costs, computer time, 
hardware and commercially 
available software, travel, 
space, supplies, telephones, 
photocopying, and so forth. 
This se ction of the APD also 
provides the budget and the 
cost allocation to be used 
during the Planning Phase. 
Total Project Cost    Estimated project  State and Federal shares, cost distribution 
costs 
This section provides a gross 
estimate of total project costs 
for the entire system 
acquisition  including 
planning and 
implementation. This 
information is very preliminary 
and will be updated in the 
Implementation APD. 
MANDATORY FUNCTIONAL REQUIREMENTS 
Medicaid Immunization Registries 
Category  Section  Content  Description 
Core Requirements  Identifiable Information  Medicaid Information	 The Immunization Registry must contain a field 
for a child's Medicaid Identification Number 
The Immunization Registry must contain fields for 
the Child's first, last and  middle names, birth 
date, sex, birth State/county, race/ethnicity and a  date, sex, birth State/county, race/ethnicity and a 
guardian's first, last and middle names. 
The Immunization Registry must contain fields for 
the vaccination and date of administration 
Vaccination Information 
To the extent possible, the Immunization Registry 
must  identify  the  provider  who  adminsters  a 
specific vaccination to a child 
The  Immunization  Registry  must  establish  a 
registry record for children no more than 6 weeks 
after birth and keep them within the system unitl 
the  reach  the  age  of  18.  At  that  time,  in 
accordance with State and local statutes and 
laws,  the  child's  records  may  need  to  be 
expunged  from  the  Immunization  Registry. 
Additionally,  the  Registry  must  identify  the 
following: 
Case Management  Enrollment 
a. Adoptions; records information about adoptive 
services,  including  the  guardian's  information 
within the parameter of State law. 
b.  Deaths; record information about a Medicaid 
child's death before the age of 18. 
The  Immunization  Registry  must  contain 
information on contraindications and personal 
and/or philosophical exemptions. 
The  Immunization  Registry  must  automate  a 
reminder/recall service that alerts guardians of 
Core Requirements  Case Management  Medicaid children as to the need for a series of 
(continued)  (continued)  vaccinations.  Such  information  would  be
garnered from the immunization history of each 
child. This level of functionality would require that 
the name and address fields on the immunization 
Case Review/Evaluation record be completed. 
To the extent possible, the Immunization Registry 
must be accessible by all providers in their place 
of practice.  The Registry must enable providers 
access to vaccination histories at the time of a 
scheduled  encounter  to  determine  the
vaccinations needed.  The Immunization Registry must  automatically 
determine  the  immunization(s)  needed,  in
complaince with current reccomendations for the 
Centers for Disease Control and Prevention, when 
Monitoring Service  an individual presents for a vaccination. 
The Immunization Registry must be capable of 
automating  and  managing  community-
coverage assessments. 
The Immunization Registry must have the ability 
to receive and process immunization information 
within one month of a vaccine administration 
Resource Management  Provider Support 
The  Immunization  Registry  must  be  flexible 
enough  to  add/delete  vaccines  as  new
vaccinations  are  added  to  the  recommended 
schedule and others are removed. 
The  Immunization  Registry  must  have  the
capability to use the HL-7 defined code set for 
Provider Support 
exchanging information 
The  Immunization  Registry  must  consolidate 
Core Requirements  Resource Management  immunization  records  from  multiple  sourtces. 
(continued)  (continued)  Such  functionality  would  also  include  de
duplication and quality checks. 
Resource Support 
The Immunization Registry must be backed up 
regularly and backup media must be stored in a 
separate location. 
If an Immunization Registry is constructed as part 
of a State's MMIS, then it must have an interface 
with a Statewide system that, at a minimum 
Interface Requirements  exchanges data on a weekly basis. To the extent 
that such a Statewide system exists, it must 
integrate the entire population of children from age 
0  to  18  that  can  be  immunized  along  with 
Medicaid children. 
Mandatory Interfaces 
If the Immunization Registry is built outside of a 
State's  MMIS,  then  an  interfade  that,  at  a 
minimum, would exchange data weekly basis, 
must be constructed to link the MMIS with the 
Immunization Registry.  This must be done to 
fully populate the registry with Medicaid children 
in order to provide immunization rates.  Additionally, to the extent possible, the State 
Registry may also decide to interface or 
intergrate with one or more of the following: 
a.  Child Welfare (SACWIS) 
Optional Interfaces 
b.  Women, Infants and Children (WIC) 
c.  Early Periodic Screening, Diagnosis and 
Treatment (EPSDT) Program 
d.  Bureau of Vital and Health Statistics 
e.  Children's Health Insurance Program, (S 
CHIP) 
f.  Public Health Clinics 
Optional Interfaces 
Interface Requirements  g.  Health Information Systems (HIS) 
(continued) 
h.  Vaccine Management System (VACMAN) 
(CDC) 
I.  Others