Vaccines for Children Program (VFC) For State Immunization Projects VACCINE MANAGEMENT & ACCOUNTABILITY
Vaccine Management & Accountability Requirements, Responsibility, Fraud & Abuse

On this page:

• Vaccine Management
  • Inventories
• Ordering
  • Provider Procedures
  • State/Grantee Procedures
  • CDC Procedures
• Billing and Payment for Vaccines
• Vaccine Storage and Distribution Systems
• Vaccine Management Summary
  
• Vaccine Accountability
  • Responsibilities
    • Provider Requirements and Responsibilities
    • State Health Department Reqs & Responsibilities
    • Medicaid Requirements and Responsibilities
    • Federal Agency Requirements and Responsibilities
• Fraud and Abuse
  • Differentiating Fraud from Abuse
  • Agency Roles In Controlling Fraud and Abuse
  • Identifying Fraud and Abuse
  • Effective Collaboration
  • Exclusion of Providers

Management of a State/Grantee’s vaccine supply is one of the most important activities conducted by an Immunization Program.

Regardless of all the hard work we put into educating people about the importance of immunizations, if we administer even a single dose of non-viable vaccine to anyone, we have not accomplished our mission.

Therefore, this section of the website is dedicated to proper vaccine management technique and the resources available to help you.

Immunization Grantees must ensure that adequate vaccine supply is available at all times and that providers have access to needed vaccines in a timely, cost-efficient manner.

Vaccine funding must be carefully managed to ensure that the amount of vaccine ordered is justified by the eligible VFC population served.

Essentially, there are three elements to vaccine management. These elements are:

1. Proper storage and handling procedures that maintain the viability of vaccine;
2. Procurement and ongoing replenishment of adequate vaccine inventory;
3. Efficient distribution of vaccines to eligible providers, while maintaining the cold chain.

CDC has developed a number of publications and a new video that describe proper vaccine storage and handling procedures. These publications include:

• “Vaccine Management: Recommendations for Handling and Storage of Selected Biologicals, and Guidelines for the Storage and Handling of Vaccines.”

• "Vaccine Storage and Handling Toolkit", that includes a video and printable guide.

Special Note: The State of Utah recently published their own version of “Vaccine Management, Handling and Storage Details for Vaccines”, and has agreed to make the art work for this document available to interested Grantees that would like a document that serves as your State’s guidance on this issue. Please email IMMUNEUTAH@UTAH.GOV, or call the Utah Immunization Program at (801) 538-9450, or consult their website: www.immunize-utah.org
Accessibility Note: Text-only version of guide for screen-reader devices.

Vaccine Inventories

Immunization Grantees must maintain adequate inventories of vaccine to meet the routine needs of providers administering publicly purchased vaccines. These vaccine stockpiles should also be sufficiently large enough to withstand temporary interruptions in vaccine supply and vaccine-preventable disease outbreaks. However, immunization Grantees must also ensure that these inventories are not excessive, minimizing the risk of vaccine wastage due to expiration or storage failure. A reasonable inventory is about 90 days, with replenishment orders taking place every 30 days, for a total of approximately 120 days of product on hand at any given time.

The first step to establishing an adequate vaccine inventory is to evaluate the State’s publicly purchased vaccine needs. These evaluations should represent at a minimum, the vaccine needs of the Grantee area for one calendar year. Furthermore, it is important that these evaluations be subdivided by month to accurately represent the “seasonality” of vaccine usage. State/Grantee estimates of need should be based on hard data and not opinion.

Many different methodologies are used by Immunization Programs to identify future vaccine needs. One of the principal methods is to use historical vaccine usage and/or distribution data over a number of years to establish an average annual increase [or decrease] in vaccine usage. This average annual increase is applied to current usage/distribution data to establish monthly vaccine needs for the upcoming calendar year. These monthly estimates may be used to establish vaccine order thresholds for the upcoming year and will help the Immunization Program develop an accurate vaccine budget and spending plan. It is important to monitor the accuracy of vaccine need projections and to make adjustments to the program’s spending plan and order thresholds as necessary.

While historical usage patterns may reflect provider demand, they may not accurately reflect a program’s true vaccine need. The use of historical patterns may compound a problem as they do not necessarily validate the actual need, but rather, may perpetuate poor vaccine management habits.

An immunization program should evaluate actual need by multiplying the eligible cohort (those eligible to receive VFC, 317, and state funded vaccines) by the current ACIP recommendations. This number may be adjusted to reflect additional groups of children being covered under the state program (e.g., catch-up programs or under outbreak situations, booster doses for adolescents, etc.).

This exercise will allow comparison of actual need with historical usage. If the number of doses is roughly comparable within five percent, then little needs to be done and you may use either method to calculate vaccine need.

If the number of doses generated by the various methods differ by more than five percent, then the immunization program should carefully evaluate the discrepancy to determine if diversion, wastage, over or under vaccination, or erroneous assumptions are being made that may result in excessive vaccine loss or over purchasing.

Vaccine Ordering

States/Grantee’s are responsible for:

• Receiving, reviewing, and approving vaccine orders from all providers.
• Identifying funding sources and apportioning VFC costs based on the VFC eligible population.
• Forwarding vaccine orders to CDC/NIP via VACMAN.
• Comparing vaccine orders to the ordering facility’s provider profile. The periodic review and validation of the provider profile data is essential for program vaccine accountability.

States/Grantees are categorized as using one of the following supply methods:

• Universal
  Immunization program supplies all vaccines to all providers to vaccinate all children.
• Universal Select
  Immunization program supplies most vaccines to all providers to vaccinate all children (e.g. pneumococcal conjugate vaccine supplied only for VFC-eligible children).
• VFC & Underinsured
  Immunization program supplies all vaccines for VFC-eligible and underinsured children to all VFC-enrolled providers.
• VFC & Underinsured-Select
  Immunization program supplies most vaccines for VFC-eligible and underinsured children to all VFC-enrolled providers (e.g. pneumococcal conjugate vaccine supplied only for VFC-eligible children).
• VFC Only
  Immunization Program supplies all vaccines for VFC-eligible children only.

  Provider Procedures

  Public and private providers enrolled in the VFC program are responsible for the proper maintenance of their vaccine inventory and for ordering vaccine in the appropriate amounts.

  It is recommended that private providers calculate the amount of vaccine they generally use in a 30 day period (monthly usage) and use that figure as their basis for ordering vaccines up to 12 times annually.

  To avoid shortages, encourage providers to order replenishment vaccines at least 15 days in advance of their actual need. Providers must complete a Vaccine Order Form and forward it to the Immunization Grantee or their designated order point of contact.

  Distribution costs of the manufacturer, the States, and CDC, are directly related to the administrative processing and packaging time, shipping expenses, and the number of shipments per year.

  To keep administrative and shipping costs low, encourage providers to order all vaccines or antigens at one time. Distribution costs related to vaccine are a relatively small percentage of cost when compared to the overall value of the vaccine. The risk of loss of vaccine in individual providers’ refrigerators or freezers is much greater than the likelihood of loss from a State depot or commercial supply center. Therefore, the modest additional cost of more frequent shipments is outweighed by reduction of risk from storage failure or mishandling of large amounts of vaccine at the provider level.

  A combination of VFC, 317 grant, and State/local funds are used to purchase vaccine. Providers who receive public purchased vaccines from multiple funding sources should not submit separate vaccine orders for each funding source. Only one order is necessary; the Grantee’s will apportion costs.

  Providers who maintain vaccines for private pay patients are required to keep a separate inventory for their public and private purchased vaccines.

  NOTE: While it is permissible to occasionally borrow from one vaccine inventory to serve individual children, this vaccine must be replaced from the other source and this practice must be the exception and not the rule.

State/Grantee Vaccine Ordering Procedures

States/Grantees process vaccine orders from all enrolled providers. With the exception of Varicella vaccine orders, multiple provider orders are combined and forwarded to CDC.

States/Grantees are responsible for totaling vaccine orders by type and number of doses needed, apportioning costs to the appropriate funding sources (VFC, 317 grant, and/or State or local funds), and forwarding orders to CDC.

Note: Apportionment of vaccine costs for VFC must be based on specific VFC-eligibility data received from provider profiles or from other hard data compiled by the Grantee, that accurately documents the eligible population upon which the VFC vaccine costs are apportioned.

There are three funding sources for vaccine orders placed through CDC’s contracts: VFC, 317 grant, and State or local funds. CDC approves all orders placed through these contracts and forwards orders to the manufacturer. Vaccines are shipped from the manufacturer to a State/Grantees Depot or contracted third party vaccine distributor. Varicella is shipped directly to providers in almost all states by the Merck Vaccine Division.

States/Grantees have an essential obligation to ensure vaccine purchase amounts are correctly apportioned across the three funding sources. VFC vaccine purchases cannot exceed the established VFC-eligible population.

States are strongly encouraged to purchase all vaccines through CDC’s contracts. Exceptions include:

• Vaccines for which CDC has not negotiated an acceptable amount of product;
• Higher contract prices than Grantees are able to negotiate themselves;
• Delivery cannot be ensured within required timeframes.

Such occurrences are very rare. Of course, it is necessary for states to contract for vaccines (e.g., Td, DT) for which CDC has been unable to establish a contract.

All State/Grantee purchases outside of CDC’s contracts should be reported to CDC. This includes the vaccine type, the number of doses ordered, and the cost. Reporting should be made to your CDC VFC Consultant.

States are obligated to review provider orders for accuracy and appropriateness. States are authorized to modify provider orders if in their judgment the amount of vaccine ordered differs significantly from the provider or State’s estimated need as reflected by the Provider Profile.

States should discuss the order with the provider before adjusting orders. For example, health department staff should query a provider who orders 500 doses of MMR vaccine annually to vaccinate the clinic population that had been previously estimated on the Provider Profile to be 50 children.

CDC has provided computer software (VACMAN) to assist Grantees in implementing and maintaining an automated vaccine ordering system. VACMAN will:

• Process public and private provider vaccine orders.
• Reflect the amount of the total purchase to be paid by VFC, 317 grant, and State/local funds.
• List the total number of doses of each vaccine type ordered by provider.
• Cross-check vaccine orders of individual providers with the State's "Provider Enrollment" files to ensure each provider is registered.
• Cross-check vaccine orders of individual providers against the Provider Profile or other established data source and identify discrepancies.

Please note: Vaccine orders that exceed the data source should not be routinely over-ridden by the vaccine data entry clerk. Such action defeats the purpose of the crosscheck. If the Provider Profile data is not in agreement with the requested amount of vaccine, it is a good indication that the profile may be out-dated and in need of re-certification.

• Cross-check shipping and receiving information to confirm that vaccine orders placed by a provider are received by the provider, and at the right address.
• Utilize VACMAN for central depot inventory tracking, whether it is their own State/Grantee run depot, or a third party distributor.
• Track all vaccine by lot number from the manufacturer to the provider who received it.
• Send to NIP within three days confirmation reports on all vaccine shipments received.

Grantees must use VACMAN to transmit VFC, 317 grant, and State Optional vaccine orders placed through CDC’s contracts. CDC will continue to provide training and technical assistance to Grantees using the CDC-provided hardware and software.

CDC Procedures

CDC will enter all vaccine orders into a computerized system that will maintain:

• A separate accounting system for VFC and 317 grant awards; VFC, 317 grant and optional purchase expenditures; and VFC and 317 fund balances for each Grantee.
• Track the total number of vaccine doses ordered by antigen type from each Grantee.
• A purchase order and billing system between CDC and the manufacturer for the
  payment of VFC and 317 grant funded orders.
• Track vaccines by lot number from the manufacturer to the Grantee.

Within 48 hours of receipt, CDC will review, approve and forward all vaccine orders to the appropriate manufacturer for direct shipment to a Grantee’s depot or third party distributor.

Bulk shipments will only be sent to vaccine depots as directed by the Grantee. Because the Grantee or third party distributor ships the vaccine to providers and local distribution points, it is not necessary to include the names and addresses of the providers who will eventually receive the vaccine when sending orders to CDC or the manufacturers.

Billing and Payment for Vaccines

The vaccine manufacturer receives vaccine orders from CDC (for VFC, 317 grant, and State-funded vaccine orders) and ships the vaccine to a central depot in each State or to an authorized vaccine storage and distribution contractor, or in the case of Varicella vaccine, directly to health care providers.

The manufacturer bills CDC, NIP for all vaccine orders purchased with VFC or 317 funds. NIP forwards the bill to the CDC Financial Management Office (FMO), which converts funds already obligated during the vaccine ordering process into expenditures, adjusts account balances for VFC and 317, and forwards payment to the manufacturer after the individual bulk orders are acknowledged as having been received by the Immunization Program. The only exception to this receiving requirement is the individual shipments of Varicella to provider offices. The CDC Financial Management Office does a random telephone verification of Varicella orders received and invoiced by the manufacturer.

When Grantees place vaccine orders through CDC using State or local funds, the manufacturer directly bills the Grantee. Vaccine manufacturers provide NIP with a monthly Statement of all vaccines purchased off CDC’s contracts with State or local funds.

Vaccine Storage and Distribution Systems

Grantees should keep a 90 day supply of vaccine at each central depot at all times, and dispense first the inventories with the shortest expiration dates. It is reasonable to order replenishment inventory once every 30 days.

Immunization Programs may choose from the following vaccine storage and distribution options:

• Centralized System: Shipment to Central/Regional State/Grantee Depots

  Vaccine manufacturers ship bulk quantities of vaccine directly to a central or regional Grantee depot. This is where the vaccine is stored for subsequent shipment to all eligible public and private providers or the vaccine is sent to local distribution points, such as County Health Departments, that supply the vaccine to individual providers.

  In order to minimize the mishandling of vaccine and increased distribution costs, CDC strongly discourages the practice of adding numerous vaccine sub-depot links to the distribution chain. The more complex a distribution system, the more likely it is that vaccine will be compromised.

• Centralized System: Third-Party Distributor

  Vaccine manufacturer’s ship bulk quantities of vaccine directly to a third party distributor who stores and delivers all public purchased vaccine on behalf of the Grantee. In some instances, the contractor may forward vaccine to local distribution points, such as County Health Departments, that supply the vaccine to individual providers.
  
  Grantees may decide to establish a contract with a third party distributor for a variety of reasons. An immunization program may determine that the existing distribution infrastructure lacks the capacity to handle distribution to additional providers or the ability to adequately store and handle additional amounts of vaccine. Or the Grantee may decide that the liability for a potential catastrophic vaccine loss is too great a risk. In any event, budget constraints, facility challenges, and/or personnel restrictions may prevent the correction of these infrastructure limitations; thus, the need to contract with a third party distributor.

  A Grantee may also decide to contract with a third party distributor in order to lower their overall distribution costs. It may turn out though that all programs are not able to lower their distribution costs by contracting with a third party distributor. Vaccine distribution costs are often determined by the volume of vaccine being distributed by the contractor, the number and location of distribution sites, the payment method specified by the program (per dose vs. per shipment) and the terms of the Grantee’s contract.

  • Combination Storage and Distribution System

  The manufacturer ships bulk quantities of vaccine directly to the Grantee’s central or regional depots. This is where the vaccine is stored for subsequent shipment, usually limited to public providers. The manufacturer also ships bulk quantities of vaccine to a third party distributor who stores the vaccine for distribution primarily to private providers.

Vaccine Management Summary

Proper vaccine management and efficient distribution is essential to the success of any Immunization Program. Failure to maintain appropriate inventories of vaccine and to distribute these vaccines in an efficient, cost effective manner may have a negative impact on vaccine coverage and budgets. To assist Grantees, CDC has developed a Vaccine Forecasting Application (VOFA) that provides a standardized methodology for vaccine need based on Federal, State, and local population data and ACIP schedule recommendations. VOFA software will help Immunization Programs manage their vaccine supplies in a cost efficient manner. VOFA is now routinely being used by all Grantees in determining their annual vaccine needs.

Vaccine accountability is one of the VFC Programs highest priorities and essential component. Immunization Grantee’s have primary responsibility for developing and maintaining vaccine accountability systems which:

• Ensures that vaccine loss and wastage is measured and minimized.
• Ensures that vaccines purchased with VFC funds are administered only to VFC-eligible children.
• Protects against fraud and abuse.
• Ensures the proper apportionment of VFC vaccine purchases based on the VFC-eligible population of the Grantee’s State/Territory.

Since VFC program implementation in 1994, the National Immunization Program has provided ongoing policy guidance and technical assistance to Immunization Grantees regarding the establishment and maintenance of effective vaccine accountability systems.

Accountability Responsibilities

Provider Profiles

All States/Grantees should crosscheck vaccine orders against Provider Profiles and other pre-set determinants to:

• Ensure the appropriateness of vaccine orders.
• Minimize vaccine loss/wastage.
• Detect potential fraud and abuse.

States/Grantees are required to complete Provider Profiles on all VFC-enrolled providers.

NOTE: Provider Profiles should be based on data and not provider "guesstimates".

Profiles may be based on data gathered from doses administered reports, the vaccine replacement method or benchmarking. Other sources of information may include State Medicaid claims data insurance information, provider encounter data or registry information.

The determinants may include vaccine-ordering patterns of providers, birth and population information, provider profile information, and/or other indicators of expected vaccine use.

Implementation of such a system enables the State to limit orders to prevent excessive stockpiling of vaccine at the provider site that could result in vaccine diversion, wastage or misuse.

VACMAN may be used to routinely crosscheck between Provider Profiles and vaccine orders, enabling the State to identify provider orders that do not match their Provider Profiles.

Totals from Provider Profiles should also be compared to eligible populations in the annual Population Estimates Survey. Provider Profile totals should not be greater than the eligible population.

Provider Site Visits

Regardless of the type of vaccine accountability system employed, all Immunization Program Grantees are required to conduct annual VFC provider site visits in both the public and private health care sectors.

Medicaid Partnership

Immunization Program Grantees are required to coordinate VFC activities with their Medicaid programs. When appropriate, State Medicaid staff should be involved in VFC program recruitment and site visits. Also, Immunization Program Grantees should work closely with their Medicaid counterparts to develop systems to review provider billing patterns, detect possible vaccine fraud and abuse, and participate or make recommendations on immunization policies pertaining to Medicaid managed care contracts.

VFC-eligibility Screening

Vaccine accountability policies will help Immunization Program Grantees comply with the legal requirements of the VFC Program as stipulated in the Omnibus Budget Reconciliation Act (OBRA) of 1993. Grantees are required to enroll providers into the VFC Program, screen patients for VFC-eligibility, and follow the ACIP immunization guidelines for VFC-eligible children.

Universal Purchase States

Grantees that have universal purchase policies have the option of using aggregate Grantee data to support VFC funding apportionment for vaccine purchase. The utilization of aggregate Grantee data (Medicaid data, information on uninsured patients, census data, vaccine usage, vaccine ordering patterns, etc.) enables the Grantee to apportion the VFC funded vaccine costs.

For example, if the VFC-eligible population for the Grantee is 50 percent (based on VFC eligibility data), then Grantee vaccine costs for the year would be apportioned (at the Grantee level, rather than the provider level) to reflect 50 percent costs.

The amount of funds available through 317 or state budgets does not change the VFC support amounts.

Vaccine orders that differ greatly from past vaccine ordering patterns can be identified and rectified with individual providers. Universal purchase Grantees requiring doses administered reporting are encouraged to include VFC-eligibility on the reports.

Listed below are four provider level methods that have been proven to strengthen vaccine accountability systems. Grantees, regardless of the type of vaccine supply policy employed, are encouraged to incorporate one or more of these accountability activities into their State plans.

1. Doses Administered Reporting

Requiring vaccine usage, wastage and inventory reporting (including vaccine expiration dates) when compared to vaccine received, enables Grantees to analyze vaccines administered and in inventory at the provider level. Comparison of this information with vaccines ordered permits identification of vaccines that are diverted or wasted at the provider level. In addition, doses administered data can be cross-checked against existing data (e.g., Medicaid claims) as an indirect method of ensuring that VFC vaccine is being administered only to VFC-eligible children.

Method: Doses administered reporting requires that a provider keep a tally sheet/log to account for each vaccine dose administered by vaccine type AND eligibility category (VFC, other public or private status).

This method CANNOT be used unless the VFC-eligibility categories are added to the doses administered tally sheet/log and reports.

Practices/clinics can maintain this log either manually or as part of a computerized database. The tally sheet/log should include: date the vaccine was given, type of vaccine administered, criteria through which the child is VFC-eligible and age of vaccine recipient and dose in series (optional). At the end of a defined time period, providers will transfer the totals from the tally sheet to a doses administered report. Providers may be required to submit their vaccine usage data on a monthly or quarterly basis or when ordering additional vaccines.

Preventing Fraud and Abuse:

• To receive VFC vaccine, providers enrolling in the VFC program must agree to submit vaccine usage and inventory reports that document VFC eligibility and doses administered data.
• Every order submitted by a provider is compared to the profile established by the vaccine usage reports. Orders exceeding expected usage are identified by VACMAN. State Immunization Program staff can contact the provider in question and determine if distribution of additional vaccine is justified or adjustments to the profile need to be made.
• Validity of the data submitted by the provider can be assessed during site visits by comparing the vaccine profile usage or inventory data to patient eligible VFC screening forms on file in the provider’s office.

Minimizing Vaccine Wastage and Diversion:

Vaccine orders exceeding the Provider’s profile or doses administered report may indicate that previously supplied vaccine is being wasted, expired or used improperly. These orders will be identified by VACMAN, allowing the Immunization Program to investigate to determine if vaccine is being mishandled.

2. Benchmarking

Requiring providers to report vaccine usage and patients served, by eligibility category, for a defined period, rather than on a continuous basis, enables the Grantee to establish projections of vaccine need at the provider level by prorating the use for a 12-month period. This information can be used to determine appropriateness of individual vaccine orders throughout the year and may also be used to apportion costs for vaccine orders. Benchmarking replaces provider estimates on the Provider Profile with tangible data on the number of VFC eligible children served by the provider. This will allow VACMAN to monitor vaccine ordering and identify improper vaccine utilization.

Method: With the benchmarking approach, the provider maintains a log in which all doses administered for a predetermined period of time are recorded. Typically, this information is gathered for a very limited period of time (1-3 months). The benchmarking log includes a child’s VFC eligibility status by specific category and type of vaccine administered. This data then forms the basis by which a provider’s vaccine needs for the year are prorated. It is important to consider the months in which the actual recording is done before prorating for a 12-month period as numbers may be naturally higher during certain times of the year.

Preventing Fraud and Abuse:

• To receive VFC vaccine, providers enrolling in the VFC program agree to maintain and submit a benchmark log which documents VFC eligibility and doses administered data.
• Every order submitted by a provider is compared to the profile established by the benchmark log. Orders exceeding expected usage are identified by VACMAN. Grantee Immunization Program staff can contact the provider in question and determine future vaccine needs.
• Validity of the data submitted by the provider can be assessed during site visits by comparing the benchmarking data to the VFC screening forms on file in a provider’s office.

Minimizing Vaccine Diversion and Wastage:

• Vaccine orders exceeding the Provider Profile may indicate that previously supplied vaccine had been wasted, expired or used improperly. These orders will be identified by VACMAN, allowing the Immunization Program to determine if vaccine is being mishandled.

3. VACCINE REPLACEMENT

Rather than place vaccine orders, providers would receive replacement doses based on the submission of doses administered reports. Requiring providers to report vaccine usage and patients served, by eligibility category, enables the Grantee to establish vaccine needs at the provider level. This information can be used to determine appropriateness of individual vaccine orders, and may also be used to apportion costs.

Method: Providers request a certain amount of vaccine as they enroll in the VFC program. All subsequent orders are designed to replace the initial amount of VFC or other public purchased vaccine provided. Whenever vaccines are reordered, a copy of the order is sent to the Immunization Program with an indication of the type and amount of new vaccine needed. The Immunization Program uses the report to verify that the amount of previously administered vaccine warrants shipping additional vaccine.

Grantees utilizing a vaccine replacement system can base Provider Profiles on the individual provider’s vaccine replacement report adjusted to reflect a 12-month period of time. This enables VACMAN to monitor vaccine ordering and identify improper VFC vaccine utilization.

Preventing or Detecting Fraud and Abuse:

• To receive VFC vaccine, providers enrolling in the VFC program must agree to submit doses administered reports documenting VFC eligibility and doses administered data.
• Every order submitted by a provider is compared to the Profile established by the vaccine usage reports. Orders exceeding expected usage are identified by VACMAN. Immunization Program staff can contact the provider in question and determine if order amounts are justified.
• Validity of the data submitted by the provider can be evaluated during site visits by comparing the vaccine usage and inventory data to the VFC screening forms on file in a provider’s office.

Minimizing Vaccine Wastage:

• Vaccine orders exceeding a provider’s usage may indicate that previously supplied vaccine had been wasted, expired or used improperly. This necessitates that the Immunization Program follows-up to determine if vaccine is being mishandled.

4. Statewide Electronic Immunization Registry

The use of a Statewide Immunization Information System (SIIS) to manage vaccine accountability requires:

• a mandatory VFC-eligibility field built into the system;
• vaccine administered data field;
• vaccine type field;
• registry generated doses administered reports by individual provider; and
• all provider data to be entered into the registry.

Method: The Grantee should strongly encourage providers to directly participate in the SIIS when they have such a capacity. These systems (e.g., Immunization Registry Clearinghouse) can be the most accurate method of monitoring vaccine usage and provider profiles. It must be remembered that while participation in SIIS is highly desirable, it is not a prerequisite or a requirement established by law for enrollment in the VFC program.

For providers not participating in the SIIS who still want immunization information recorded in the system, they must maintain a running tally sheet to account for each VFC-eligible child who receives a vaccination. The tally sheet should include: the date the vaccine was given, type of vaccine administered, criteria through which the child is eligible for VFC vaccine, and optional age of vaccine recipient and dose in series. At the end of a defined time period, providers will transfer the totals from the tally sheet to a doses administered report. Providers should be required to submit their vaccine usage data to the Immunization Program on a monthly or quarterly basis. The Immunization Program will enter the doses administered data into the SIIS. Statewide electronic registries incorporate all three areas of accountability and may be used to monitor vaccine loss and wastage, prevent fraud and abuse, and ensure that VFC vaccine is administered to VFC-eligible children.

By electronically registering all immunized children by eligibility category and vaccine type, Grantees will be able to:

• Calculate doses administered data and monitor vaccine inventory at the provider level. This information can be compared with vaccines ordered and distributed to identify levels of vaccine loss and wastage.
• Determine providers' vaccine usage patterns, which can be crosschecked with provider profiles and vaccine orders for consistency and appropriateness.

Preventing Fraud and Abuse:

• Providers enrolling in the VFC program must agree to report to the registry electronically or by submitting manual logs that document VFC eligibility and doses administered data.
• Every order submitted by a provider is compared to the profile established by the registry. Orders exceeding expected usage are identified by VACMAN. Immunization Program staff can contact the provider in question and determine if distribution of additional vaccine is justified.
• Compare the number of children served by eligibility category (Medicaid-enrolled children), with other existing data (Medicaid data). This procedure will assist in the identification of potential fraud and abuse and help to ensure that VFC vaccine is administered only to VFC-eligible children.
• Validity of the data submitted by the provider can be assessed during site visits by comparing the registry data to the VFC screening forms on file in a provider’s office.

Minimizing Vaccine Wastage:

• SIIS might also consider installing a vaccine wastage module that would allow providers to report vaccine losses.
• Vaccine orders exceeding a provider’s profile may indicate that previously supplied vaccine may have been wasted, expired or used improperly. These orders will be identified by VACMAN, allowing the State Immunization Program to investigate to determine if vaccine is being mishandled.

Provider Requirements and Responsibilities

• To participate in the VFC program, a provider submits a completed Provider Enrollment form* and a Provider Profile form* to the state/Grantee health department for review and storage.
• At a minimum, the Provider Profile is updated annually. It may be revised more frequently if the provider's practice size or vaccine needs change or at State discretion.
• On the Provider Profile, the provider establishes the number of children (based on data) within each of three groups (<1 year of age, 1-6 years of age, and 7-18 years of age) he or she will vaccinate in the next 12 months. The form also asks the provider for the number entitled to VFC vaccine by eligibility category (Medicaid-eligible, uninsured, underinsured, American Indian/Alaska Native). These numbers must be based on real data, not provider estimates.
• On the Provider Enrollment form, the provider agrees to screen children and only administer VFC vaccine to those who are VFC-eligible. The provider also agrees to maintain a Patient Eligibility Screening Record for all VFC-eligible children. The screening record will be stored for a period of 3 years, after service to the patient has been completed, unless state policy establishes a longer archival period. VFC screening records will be shown to state or DHHS representatives, upon request.
• Providers agree to screen all patients less than 18 years for VFC eligibility on each visit and update immunization record as the child’s status changes.
• Each provider offers vaccine to VFC-eligible children at no charge, charges no more than the CMS established regionalized fee caps for administration, complies with the ACIP vaccination schedule, and ensures that no VFC-eligible child is denied a vaccination because of the parent’s inability to pay the administration fee.
• Providers will distribute written Vaccine Information Statements and maintain records, in accordance with the National Childhood Vaccine Injury Act, and will report adverse events following vaccination as they occur.
• Providers agree to adhere to other reporting requirements of their state/Grantee, such as vaccine doses administered, vaccine inventory, vaccine lost/wastage, etc.
  Accessibility Note: HTML version of guide for screen-reader devices.

*Accessibility Note: All of these forms provided above in .pdf format are also available in text-only format for screen-reader devices via the Forms page.

State Health Department Requirements and Responsibilities

• VFC program planning, implementation and management.
• Continually recruiting VFC providers.
• Promoting the VFC program to both consumers and providers.
• Evaluating VFC program operations.
• Certifying that existing state laws pertaining to health insurance policies and coverage remain in place.
• Exercising quality control over vaccine ordering and distribution.
• Strictly enforcing vaccine accountability.
• Charging vaccine purchases to VFC funds in proportion to the VFC eligible population.
• Estimating vaccine needs based on the number of doses to be purchased by each funding source (VFC, 317 grant, state/local).
• Estimating costs to be incurred by the state for VFC program operations.
• Estimating the amount of VFC funds needed to purchase vaccine.
• Estimating the amount of state/local funds needed to purchase vaccine.
• Estimating the amount of 317 grant funds needed to purchase vaccines.
• The number and percentage of provider sites serving children who are participating in the VFC program.
• The total number of children served by the VFC program within each of the following eligibility categories:
  • Medicaid enrolled
  • Without health insurance
  • American Indian, Alaska Native
  • Underinsured (served through an FQHC/RHC)
• Coordinate with Medicaid on the implementation of the VFC program.
• Enroll providers into the VFC program.
• Maintain provider enrollment records and Provider Profiles for at least 3 years after enrollment is discontinued.
• Obtain the name, medical license number and Medicaid provider number (if applicable) of each provider administering vaccine at an enrolled site.
• Update provider profiles annually ensuring that completion was based on real data and not estimates. Data should accurately identify the number of VFC-eligible and non-VFC-eligible children served in the <1, 1-6, and 7-18 age groups.
• Supply vaccine to VFC-enrolled providers in accordance with ACIP recommendations and ACIP- VFC resolutions.
• Review and approve provider vaccine orders, ensuring orders are consistent with the Provider Profile and accurately reflect each provider’s vaccine needs.
• Implement and maintain vaccine accountability systems which minimize vaccine diversion and wastage.
• Minimize fraud and abuse of VFC vaccine, ensuring administration only to VFC-eligible children.
• Identify and investigate reported instances of fraud and abuse associated with the VFC program within 5 days of the initial report. Report all such instances to NIP/PSB.
• Collaborate with the State Medicaid program concerning investigations of alleged VFC fraud/abuse.
• Correctly apportion VFC vaccine purchases to ensure that purchases are consistent with the proportion of VFC children to be served (reference: VFC population estimates survey).
• State health officials or their designees have the right and responsibility to review records in the provider's office. A plan that describes States/Grantees accountability procedures should be designed to:
  • minimize vaccine loss, wastage, and diversion,
  • protect against fraud and abuse,
  • ensure that vaccines purchased with VFC funds are administered only to VFC-eligible children,
  • ensure that correct apportionment of vaccine costs and costs associated with delivery occurs between funding sources (VFC, 317 and State/local).
• Provider Profiles must be based on real data. States may select from one or more of the following data sources to complete Provider Profiles:
  • benchmarking,
  • doses administered reports that include information by child and eligibility,
  • State Medicaid claims data,
  • provider encounter data,
  • registry information for the number of children within each of three groups (<1 year of age, 1-6 years of age, and 7-18 years of age) by eligibility category (e.g., Medicaid-enrolled, uninsured, underinsured, American Indian/Alaska Native).
• All States/Grantees are required to annually conduct provider site visits to at least 25% of the total VFC-enrolled providers. VFC provider site visits may be based on one or more of the following criteria: state/Grantee discretion, high-volume vaccine usage/ordering patterns, health care providers who are outliers with respect to vaccine ordering, reports of vaccine abuse or fraud, Medicaid billing inconsistencies and/or random selection.
• During VFC monitoring visits Grantees should ensure that providers are screening all patients on each visit to determine VFC eligibility and retaining records for all VFC-eligible patients. Verify provider profile information, review vaccine storage and handling practices, and provide appropriate educational interventions as necessary.
• Conduct VFC Provider Feedback Surveys (see Appendix A-11) at least every two years. By conducting a survey, States/Grantees should evaluate different aspects of the VFC program and better understand if the VFC program is meeting the needs of enrolled providers.
• The Social Security Act requires each state participating in the VFC program to certify in writing that it has upheld existing laws requiring health insurance policies or plans to provide immunization benefits. Also, that the state has not proposed, modified, or repealed any laws that would result in a limitation or reduction in immunization coverage. This certification must be signed by an authorized state official and forwarded to CDC, NIP each year.

  Imposing Additional State Requirements Upon VFC Participants:

  The Social Security Act precludes a state from imposing additional qualifications or conditions upon providers wishing to participate in the VFC program without the permission of CDC (designated agency). If a state wants providers to meet additional conditions before they are accepted in the VFC program, the conditions and intent must be submitted in writing to the CDC, NIP for approval.

State Health Department Recommendations

• Ensure providers are following ACIP recommendations by assessing the immunization status of VFC-eligible children during VFC monitoring visits (use CASA, mini-CASA or Hybrid).
• Evaluate VFC private provider impact on patient referral to public clinics (NIP’s evaluation tool can be obtained through your VFC Consultant).

Medicaid Requirements and Responsibilities

One of the best ways to reach the parents of potentially eligible children and to share VFC program information with them is through other family services. Medicaid currently provides services to millions of U.S. children. By sharing information and resources, the Medicaid and VFC programs should identify parents, children and health care providers who are potentially entitled to VFC benefits and devise a strategy to discuss program benefits, limitations and procedures with the targeted clientele.

The role of the Medicaid program may include:

• Recruiting current and new Medicaid providers for the VFC program.
• Sponsoring informal health education meetings for VFC or Medicaid staff to inform families and providers of the benefits offered by the program and procedures to follow for service.
• Revising state EPSDT periodicity schedules to conform to ACIP recommendations.
• Inspecting Medicaid managed care and other health care facilities to confirm that vaccinations are being administered in accordance with the ACIP schedule.
• Displaying VFC literature in areas that have primary or ancillary contact with children or including VFC literature in mailings to Medicaid providers.
• Sharing Medicaid billing data pertaining to vaccine purchases and vaccine administration with the State VFC program on a regular basis.
• Negotiating vaccine costs out of Medicaid managed care contracts while still allowing for vaccine administration reimbursement.

  Dealing with Non-Compliance

  Grantees are often faced with the situation of the provider that does things judged to be out of compliance with the terms of the Provider Enrollment agreement. If they are not committing fraud or abuse, Grantees need to develop policies for dealing with Provider Enrollment violations.

  While the focus of the VFC program is to supply vaccine to providers to improve access, Grantees must also protect the public trust. Every effort should be made to educate the provider on the terms of their enrollment in the VFC program. The policy should describe an increasing level of intervention if violations continue. Ultimately, the Grantee must decide the point upon which they will place the provider on ordering restrictions and/or remove the provider from the VFC program. Any efforts made to work with the provider should be well documented in a file that will be maintained at least three years, or in accordance with statute in order to document recurring patterns.

  Grantees should develop these policies with the assistance of their immunization advisory committee or some other type of physician committee in order to get provider input. Grantees must also consider all applicable federal or state laws and/or regulations.

Federal Agency Requirements and Responsibilities

Federal agencies are responsible for the following:

• Providing VFC program policy guidance, evaluation and technical support to states/Grantees.
• Providing financial support for the VFC program.
• Negotiating federal contracts for vaccine purchases.
• Establishing regional vaccine administration fee caps.
• Developing vaccine ordering systems and databases and providing computer hardware and software to state/Grantee VFC programs.
• Reporting on VFC program operations to appropriate entities.

The VFC program is vulnerable to fraud and abuse. Therefore, it is important for State Immunization programs to have policies, procedures and processes in place to prevent and detect instances of fraud and abuse and to ensure that vaccines are used and accounted for appropriately.

State Immunization programs should establish relationships with other state agencies and federal entities that are responsible for investigating and prosecuting fraudulent activities for Medicaid and the private sector (commercial insurance and private pay) including the state Medicaid agency, the Medicaid Fraud Control Unit (MFCU), the state Department of Insurance (DOI), and the Office Of Inspector General (OIG).

To help foster relationships, State Immunization programs are encouraged to educate investigative and enforcement agencies regarding the unique features and structure of the VFC program, in that the program integrates public purchased vaccines, Medicaid, the underinsured, and the uninsured populations.

Differentiating Fraud from Abuse

Fraud, as it is defined in 42 CFR 455.2, is “an intentional deception or misrepresentation made by a person with the knowledge that the deception could result in some unauthorized benefit to himself or some other person.”

Abuse is defined as “provider practices that are inconsistent with sound fiscal, business, or medical practices, and result in an unnecessary cost to the Medicaid program, or in reimbursement for services that are not medically necessary or that fail to meet professionally recognized standards for health care….”

Determining whether an allegation is fraud is not the responsibility of the state VFC program staff. However, reporting allegations of wrongdoing by a provider is required and such incidents should be referred to appropriate officials for further investigation and review. It is important to remember that all allegations are just allegations, until proven otherwise.

Programs have an obligation to establish the appropriate balance between operational oversight and provider’s participation. For example, when a provider has exhausted his/her VFC inventory, he may vaccinate a VFC-eligible child using his/her private inventory with the expectation his/her inventory dose(s) will be replaced by a VFC dose(s) when it becomes available. The test is that such substitutions are the exception and not the rule and that such actions do not represent a systematic process.

Agency Roles In Controlling Fraud and Abuse

State Medicaid Agency

Each state Medicaid agency has a process in place to meet certain Medicaid program integrity requirements for detecting, investigating, pursuing, and referring suspected cases of fraud and abuse to law enforcement officials. The state Medicaid agency’s Program Integrity (PI) Unit and/or its Surveillance and Utilization Review Unit (SUR) usually perform these functions. These units identify questionable provider practices and conduct preliminary investigations into complaints of Medicaid fraud and abuse. If there is sufficient reason to believe that an incident of fraud or abuse has occurred, a full investigation may be conducted and the case referred to the MFCU or appropriate law enforcement agency for development.

Medicaid Fraud Control Unit (MFCU)

The MFCU is the responsible agency for investigating and prosecuting (or referring for prosecution) violations of all applicable State laws pertaining to fraud in the administration of the Medicaid program, the provision of medical assistance, or the activities of providers of medical assistance under the State Medicaid plan. MFCUs also work with State Medicaid agencies to develop methods and procedures to identify, detect, and investigate potential fraud and abuse. The MFCU is usually located in the Office of the State Attorney General or another part of State government, which has statewide authority to prosecute individuals for violations of criminal laws with respect to fraud in the Medicaid program.

It should also be noted that violations might be reported or suspected among non-Medicaid providers who are enrolled in the VFC Program. In this instance, the Immunization Program has the obligation to evaluate the validity of the report and if it appears to be of a criminal intent, to report all findings to the Office of the State Attorney General.

Office of the State Attorney General
Department of Insurance (DOI)

Each state has a designated agency which investigates allegations of fraud and abuse in the private sector; determines whether there have been criminal violations of applicable state law including commercial health care fraud and abuse; and pursues prosecution or coordinate with the Office of the State Attorney General in pursuant of prosecution. This function is often a charge of the Office of the State Attorney General along with the state Department of Insurance.

Office of Inspector General (OIG)

The OIG in Department of Health and Human Services (HHS) is responsible for conducting investigations, audits, and evaluations, and protecting HHS programs and operations against fraud, waste and abuse. In conjunction with the U.S. Department of Justice, the OIG has the responsibility for establishing and administering a nationwide Fraud and Abuse Control Program, as authorized by the Health Insurance Portability and Accountability Act of 1996.

The OIG is responsible for overseeing the operation of the MFCUs through their certification process and distribution of Federal matching funds. The OIG has the authority within HHS to exclude from participation in Medicare, Medicaid, and other
Federal health care programs individuals and entities determined to pose a risk to the programs and/or beneficiaries.

Effective Collaboration

State Immunization programs should work with internal legal counsel and collaboratively across agencies to develop policies and procedures for detecting and reporting allegations of fraud and abuse. Note: these processes may vary by state.

Input from investigative and enforcement agencies is key to developing effective protocols for reporting allegations of fraud; sharing information; collaborating with all involved parties to determine the best course of action to pursue for suspected cases of fraud; and educating VFC staff regarding how to the properly obtain and document information when an allegation of fraud and/or abuse is reported and how to appropriately gather additional information. These activities are highly important in protecting any legal processes that may occur as a result of the investigation.

Policies and procedures should address the following:

• How to respond when an allegation of fraud or abuse is received; (This policy should include that Grantees are required to act within five days.)
• How to properly document and collect facts regarding the allegation. State programs should ensure that all available information is clearly documented and maintained for reference;
• How to determine whether or not vaccines should be removed from the provider practice;
• How and where to report allegations of fraud; (Depending upon the organization of state responsibilities, reporting may vary by state.) and
• Procedures for sharing provider information such as data regarding VFC provider ordering patterns or usage data collected by the State Immunization Program, Medicaid Management Information System (MMIS) data regarding the providers billing patterns, and excluded provider listings.

State Immunization programs must also notify their VFC Program Consultant when suspected cases of fraud are reported and update the VFC Program when the case is adjudicated. The VFC Program Consultants are also available to assist Grantees with developing and enhancing fraud and abuse initiatives.

Identifying Fraud and Abuse

The first documented case of fraud under the VFC program occurred in 1997 in West Virginia. A Medicaid provider, who was also enrolled in the VFC program, profited from selling children’s vaccines that were provided free under VFC. The provider administered public purchased vaccines to patients who had medical insurance and billed the insurers as if the provider had purchased the vaccines. As a result, the provider was sentenced to 1-1 ½ years in a federal prison.

Instances of VFC fraud and abuse are often a result of complaints or referrals from outside sources regarding a provider who has inappropriately used vaccines or billed Medicaid or private insurers for the cost of the vaccines that were received free of charge through the VFC program. VFC providers are entitled to reimbursement for administering the vaccine but not the cost for the purchase of the vaccines.

It should be noted that ensuring the integrity of the VFC program is the responsibility of everyone involved in the administration of the program. Strengthening the VFC program through development and implementation of accountability systems are important steps in the prevention of fraud and abuse and prevents unscrupulous individuals in benefiting from the program.

Additional Resources

The Centers for Medicaid and Medicare Services (CMS) National Medicaid Fraud and Abuse Initiative website at (http://www.oig.hhs.gov/fraud.html) can assist VFC Immunization program staff with identifying state specific fraud and abuse laws and contacts including: state Medicaid agency contacts and state Medicaid Fraud Control Unit contacts.

Exclusion of Providers

The State Immunization program is required to have processes in place to ensure debarred individuals and excluded providers are not allowed to enroll or participate in the VFC program receiving VFC vaccine for VFC-eligible children.

Excluded providers are individuals or entities that have been placed in non-payment status under Medicare, Medicaid and other Federal health care programs, including the VFC program by the U.S. Department of Health and Human Services, Office of Inspector General (OIG) or through Executive Order by another Executive department (e.g., Department of Transportation, Office of Personnel Management, Department of Justice, Department of Labor, Department of Defense). Exclusions of providers may occur due to OIG sanctions, failure to renew license or certification registration, revocation of professional license or certification, or termination by the State Medicaid agency.

Individuals or entities excluded by OIG or through Executive Order by another Executive department are not eligible to receive VFC vaccine for any VFC-eligible child. Exclusions remain in effect unless and until the OIG receives and grants a request for reinstatement.

Information about parties who are excluded by the OIG is found at their website (http://www.oig.hhs.gov/fraud/exclusions.html) on the List of Excluded Individuals and Entities (LEIE). Information about parties who have been placed in non-payment status by all Executive departments (including OIG’s) is found at the General Services Administration website (http://epls.arnet.gov). The GSA list is downloadable, but only as a text file. The OIG’s LEIE (which can be downloaded as a data base file) contains approximately 17,000 names; the GSA list contains approximately 30,000 names. Neither list contains Social Security numbers. The OIG also issues monthly reports on its website, which also can be downloaded as a data base file.

VFC programs should review these lists each month and disenroll any VFC providers identified on the list. Any VFC vaccine in the provider’s possession should be collected and the provider should be prohibited from receiving future shipments until the exclusion is lifted. If the exclusion is lifted, the individual or entity should be required to reapply for VFC program participation. Given the large volume of VFC provider names to review each month, VFC programs should consider establishing a protocol with the state Medicaid program to receive notification of the exclusions occurring in their jurisdiction.

Websites to Download Exclusion Lists

• http://www.oig.hhs.gov/fraud/exclusions.html (exit site)
• http://epls.arnet.gov (exit site)

This page last modified on July 27, 2006
This page last reviewed on January 27, 2004