Programs & Tools:
VFC: Fraud and Abuse
Vaccines for Children Program Topics:
Overview
As the cost of childhood vaccines increases and the complexity of immunization programs grows, the VFC program becomes more vulnerable to fraud and abuse. It is important that grantees' VFC programs have well-defined processes for prevention, identification, investigation and resolution of suspected cases of fraud and abuse within the VFC program.
The VFC program, as a component of each state's medical assistance plan, is considered a Title XIX Medicaid program. Section 1928 of the Social Security Act (42 U.S.C. §1396s) provides for purchase of vaccine for administration to VFC-eligible children—"federally vaccine-eligible children" and "state vaccine-eligible children" (i.e., those children for whom states purchase vaccine; may be limited to particular vaccines)—using federal Medicaid funds and state funds (including 317 grant funds), respectively. Medicaid-eligible children and those providers who provide care for the Medicaid population (i.e., Medicaid providers) represent the majority of VFC federally vaccine-eligible children and VFC providers. However, the VFC program is different from the Medicaid medical assistance program. It also includes other VFC program–enrolled providers and the other VFC-eligible children who qualify as federally vaccine-eligible or state vaccine-eligible and who do not participate or are not eligible for the Medicaid medical assistance program. Federal fraud and abuse laws apply to the entire VFC program. In addition, for those portions of the VFC program involving state funds, state fraud and abuse/consumer protection/medical licensure laws may also apply.
It is important for state immunization programs and the state Medicaid agencies to collaborate on the development of policies and procedures regarding VFC program fraud and abuse. In addition to using the services of state Medicaid agencies and CMS, state immunization programs, in collaboration with their state Medicaid agencies, should also use the fraud and abuse–related services of other state agencies that are responsible for investigating and prosecuting fraudulent healthcare activities and misuse of government funds.
A working understanding of what constitutes fraud and abuse is critical for persons working in the VFC program. Consistent with "fraud" and "abuse," as defined in the Medicaid regulations at 42 CFR § 455.2, for the purposes of this VFC Operations Guide, the following definitions will be used:
Fraud
Fraud is defined as 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. It includes any act that constitutes fraud under applicable federal or state law.
Abuse
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, [and/or including actions that result in an unnecessary cost to the immunization program, a health insurance company, or a patient]; or in reimbursement for services that are not medically necessary or that fail to meet professionally recognized standards for health care. It also includes recipient practices that result in unnecessary cost to the Medicaid program.
Examples of Fraud and Abuse
Fraud or abuse can occur in many ways, and some types of fraud and abuse are easier for the VFC program to prevent or detect than others, depending on how the VFC program is implemented. The VFC program should try to differentiate between intentional fraud and abuse and unintentional abuse or error due to excusable lack of knowledge. Some examples of potential fraud and abuse that VFC staff might encounter are
- Providing VFC vaccine to non–VFC-eligible children;
- Selling or otherwise misdirecting VFC vaccine;
- Billing a patient or third party for VFC vaccine;
- Charging more than the established maximum regional charge for administration of a VFC vaccine to a federally vaccine-eligible child;
- Not providing VFC-eligible children VFC vaccine because of parents' inability to pay for the administration fee;
- Not implementing provider enrollment requirements of the VFC program;
- Failing to screen patients for VFC eligibility;
- Failing to maintain VFC records and comply with other requirements of the VFC program;
- Failing to fully account for VFC vaccine;
- Failing to properly store and handle VFC vaccine;
- Ordering VFC vaccine in quantities or patterns that do not match provider profile or otherwise involve over-ordering of VFC doses;
- Wastage of VFC vaccine.
On rare occasions after further assessment of an alleged fraud or abuse incident, and in conformance with the requirements of 42 CFR §455.15, if the grantee determines that there was no intentional deception, misrepresentation or negligent deception or misrepresentation of the VFC program by the provider or office staff, the situation may be corrected through an educational referral process within the VFC program. The grantee should have clear written criteria indicating when an incident may be appropriate for an educational referral. The criteria should include both objective and subjective factors such as the amount of money lost by the VFC program; inadvertent financial gain of the provider; how the incident was identified; length of time the situation was occurring; provider's willingness to replace dose for dose lost VFC vaccine with privately purchased vaccine; and the provider's willingness to participate in the educational referral and post-education follow-up.
Determining if the alleged abuse situation is unintentional due to a clearly excusable lack of knowledge should be based on observations of the VFC staff and other appropriate investigative authorities. It should be noted that unintentional abuse or error is nevertheless still unacceptable. The response to instances of unintentional abuse or error may vary depending on the circumstances and whether other instances of fraud or abuse (either intentional or unintentional) have occurred. In appropriate circumstances, education may be the proper response in lieu of criminal enforcement. The investigative/enforcement referral requirements of 42 CFR §455.15 must be followed to determine whether an educational intervention is adequate.
For more information about fraud and abuse, including program requirements and investigating cases of fraud and abuse, please see module 10 of the VFC Operations Guide.
Return to VFC State/Territory Immunization Projects main page
.pdf files: To view and print the .pdf files on this site, you will need Adobe Acrobat Reader. Use this link to obtain a free copy of Adobe Acrobat Reader (exit). We highly recommend that you upgrade to the latest version if haven't already.
Content last reviewed on November 6, 2007
Content Source: National Center for Immunization and Respiratory Diseases