Executive Summary

This Vaccines for Children (VFC) Program Operations Guide is the first update of the guide since 2002. Since the VFC program became operational in 1994, the budget for this program has risen steadily, and in the year 2007 it is nearing $3 billion. As program costs rise, so does the need to ensure that all aspects of the program are being implemented appropriately. The content of the guide has been updated and significant changes have been made in many areas of the VFC program, including provider enrollment, vaccine management and fraud and abuse. This executive summary outlines new material added or significant changes made to key modules in the VFC Program Operations Guide. This summary does not outline all changes within the Operations Guide or even in the modules discussed below, so it should not be considered an all-inclusive summary of changes or new requirements. The user is referred to the full text of the VFC Program Operations Guide for a comprehensive discussion of these issues.

Provider Recruitment and Enrollment
The number of requirements for provider enrollment has been decreased to nine items. CDC has removed the provider enrollment form template from this version of the VFC Program Operations Guide because most grantees have created their own provider enrollment forms. All nine required items must be used, with modifications only to the items specified in Module 3, "Provider Recruitment and Enrollment."

Beginning in 2008, any additional items that grantees wish to include as requirements for provider enrollment in the VFC program must be submitted to CDC for documentation and formal approval even if approval has been received in the past. The formal process for requesting approval of additional provider enrollment requirements is outlined in Module 3. In addition, all grantees must submit their 2008 Provider Enrollment forms to CDC for review no later than October 1, 2007. All forms must be submitted even if the grantee only includes the nine federal requirements on their enrollment form. 

Module 3 also contains a new section on special populations, including eligibility screening options for patient populations that are 100% American Indian/Alaska Native or 100% enrolled in Medicaid. The section also discusses requirements for use of VFC vaccine for unaccompanied minors who present at family planning clinics without insurance information. CDC will begin gathering data on unaccompanied minors receiving VFC vaccines in family planning clinics starting in 2007 through the VFC Management Survey.

Vaccine Management
Module 6, "Vaccine Management," identifies grantee vaccine management requirements both before and after transition to centralized distribution. A key requirement is to provide initial and periodic training to VFC providers and staff, focusing on critical aspects of proper vaccine management. Grantees will need to develop simple storage and handling plan templates that VFC providers can adapt and implement in their practices.

This module also outlines the minimum vaccine management requirements for enrolled VFC providers. Each VFC-enrolled provider must have a designated vaccine coordinator and a backup person. These individuals will be points of contact for the VFC program within that office and are responsible for implementing all VFC storage and handling requirements.

Module 6 outlines the minimum storage and handling equipment a provider must have to participate in the VFC program. A grantee can include additional storage and handling equipment requirements in its provider enrollment form by submitting a request to CDC. The process for requesting approval of additional provider enrollment requirements is addressed in Module 3, "Provider Recruitment and Enrollment."

Accountability
PLACEHOLDER: Publication of Module 8, "Vaccine Accountability," is pending revision by CDC's Accountability Workgroup.

Fraud and Abuse
Grantees are required to develop and implement a written fraud and abuse policy. The required components for this policy are outlined in Module 10, "Fraud and Abuse." Each grantee will be required to submit a copy of its fraud and abuse policy annually to CDC. The first submission is due no later than December 31, 2007, and should be sent to the VFC policy coordinator.

Developing a realistic fraud and abuse policy will require grantees to work in close collaboration with the state Medicaid Agency and other agencies to develop a workable process for referring potential cases of fraud and abuse. The fraud and abuse policy will require grantees to develop internal processes for identifying fraud and abuse, a referral process to external agencies for further investigation, or an internal process for education on needed practice changes. The policy requires grantees to designate an individual position (and at least two back-ups) as the Fraud and Abuse Coordinator. Two important responsibilities of this position are to determine if the case requires referral and to notify both CDC and the Centers for Medicare & Medicaid Services (CMS) in the time frame specified in Module 10.