Questions Answered on Vaccines Purchased with 317 Funds

A: The Vaccines for Children (VFC) program is a federally funded entitlement program that provides vaccines at no cost to eligible children. CDC provides the routinely recommended childhood and adolescent vaccines at no charge to participating VFC providers.

A: A child is eligible for the VFC Program if he or she is younger than 19 years of age and is one of the following:

• Medicaid-eligible
• Uninsured
• Underinsured*
• American Indian or Alaska Native

* Underinsured means the child has health insurance, but it doesn't cover vaccines, or doesn't cover certain vaccines. Underinsured children are eligible to receive vaccines only at Federally Qualified Health Centers (FQHC) or Rural Health Clinics (RHC). An FQHC is a type of provider that meets certain criteria under Medicare and Medicaid programs. Children whose health insurance covers the cost of vaccinations are not eligible for VFC vaccines, even when a claim for the cost of the vaccine and its administration would be denied for payment by the insurance carrier because the plan's deductible had not been met.

A: Section 317 of the Public Health Service Act authorizes the federal purchase of vaccines to vaccinate children, adolescents, and adults. Over its 50 year history, Section 317-purchased vaccine has been directed towards meeting the needs of priority populations; most recently this has included underinsured children not eligible for VFC, and uninsured adults.

Section 317 discretionary funding also supports immunization program operations at the local, state, and national levels.

A: The Section 317 Immunization Program plays a critical role in achieving national immunization coverage targets and reductions in disease. Behind every vaccine given to a child, adolescent, or adult in the United States are public health systems and experts that are essential to a successful immunization program that will continue to be critical, including in the years following the full implementation of the health insurance reforms of the Affordable Care Act. Although we anticipate more Americans will have public or private insurance coverage for immunization services, other important public health functions are necessary to assure that the right vaccines get to the right people at the right time to protect their health and the health of their communities and prevent resurgences of life-threatening diseases. The Section 317 Immunization Program is expected to continue to be an essential part of our nation’s immunization enterprise.

A: It will no longer be appropriate for Section 317 vaccine to be used for routine vaccination of children, adolescents, and adults who have public or private insurance that covers vaccination. Section 317 vaccine is a precious national resource that will continue to be used to fill critical public health needs, such as providing routine vaccination for those with no insurance and responding to outbreaks of vaccine-preventable diseases.

Most importantly, the immunization systems and experts that are supported by the Section 317 Immunization Program will continue to be the backbone for the U.S. childhood immunization program -- regardless of the payer for the vaccine given -- by ensuring that childhood vaccination is accessible, safe and effective, and used most successfully to protect our most precious national resource.

A: Beginning on October 1, 2012, Section 317-funded vaccines can be used to vaccinate:

• Newborns receiving the birth dose of hepatitis B prior to hospital discharge that are covered under bundled delivery or global delivery package (no routine services can be individually billed) that does not include hepatitis B vaccine
• Fully Insured infants of hepatitis B infected women and the household or sexual contacts of hepatitis B infected individuals
• Uninsured or underinsured adults
• Fully insured individuals seeking vaccines during public health response activities including:
  • Outbreak response
  • Post-exposure prophylaxis
  • Disaster relief efforts
  • Mass vaccination campaigns or exercises for public health preparedness
• Individuals in correctional facilities and jails

A: This information can be provided to you by your state or local immunization program. Many states use a blend of VFC, 317 and, in some cases, state funding for vaccines given to healthcare providers. Some states call the vaccines or the Program "VFC" even though the vaccines provided are funded with a mix of funding sources. While you may not know the source of the vaccine funding, your state will specify guidelines of who is eligible for the vaccines that they provide you.

A: Please contact your state or local immunization program for additional questions about VFC or Section 317 vaccines.

A: The policy began on October 1, 2012 to coincide with the federal fiscal year, which begins October 1 and ends September 30. Federal vaccine contracts follow the federal fiscal year; therefore, the new policy was implemented on October 1, 2012.

The 317 program has evolved over time to fill gaps and address priorities in our vaccine programs. As ACA is implemented, more individuals will have coverage for vaccines through both public and private insurance, and nearly all children will be covered through VFC or private insurance. While childhood vaccination coverage is at record highs, there are many gaps in uninsured adults. With the changes in insurance coverage it is time to allow 317 to evolve once again to best address the needs of the individuals served by our vaccine programs. Responsible stewardship of vaccine programs and the federal funds used to support them mean that these resources must be allocated to areas of greatest need and not subsidize private insurers.

A: Yes. This policy goes into effect beginning October 1, 2012. The 317 vaccine funding policy is not dependent on ACA, although improvements in vaccine coverage mandated by the ACA will facilitate implementation. This policy is to ensure that we are all doing our part to ensure responsible fiscal management of public resources.

A: Yes. CDC has the authority as well as the responsibility for the administration of 317 funds under the enacting legislation and 45 CFR 92. Given this responsibility, CDC is implementing this policy in our continued effort to ensure fiscal accountability for these funds.

A: The clarification of the 317 vaccine policy, generally, focuses on ensuring that insured individuals receive their vaccinations through their insurance provider network, and are not subsidized through federal funding.

Awardees may not administer Section 317 vaccines to fully insured children or adults, except in limited circumstances described below. An underinsured child may receive Vaccines for Children (VFC) funded vaccine if the child is seeking vaccinations in a Federally Qualified Health Center (FQHC) or Rural Health Clinic (RHC) or under approved deputization agreements.

In circumstances other than "exceptions" specified in the policy, 317 vaccines may not be used to vaccinate:

• Fully insured children and adults seen in public clinics
• Fully insured children and adults seen in private provider offices
• Adults with Medicare Part B
• Adults with Medicaid coverage for vaccines
• Fully insured adults seen in STD/HIV clinics or drug treatment centers
• Fully insured parents of newborn infants participating in Tdap cocooning projects
• Fully insured adults at high risk for acquiring Hepatitis A
• Fully insured children and adults with a high co-pay or deductible
• Fully insured students receiving vaccines for college entry at Public Health Clinics or College health facilities
• Fully insured children and/ adults in low medical access areas
• Fully insured adults in LTCs/eldercare
• Fully insured children in school-based health centers or clinics
• Fully insured "high risk" occupational groups (e.g. EMS, first responders, health care workers) for hepatitis A or B or other diseases
• Fully insured adults and children receiving vaccines as part of a community wide outreach event (including mobile vans and health fairs)
• Children who are insured by SCHIP standalone programs

Exceptions: 317 vaccine funds may be used to vaccinate the following:

• Newborns receiving the birth dose of hepatitis B prior to hospital discharge that are covered under bundled delivery or global delivery package (no routine services can be individually billed) that does not include hepatitis B vaccine
• Fully Insured infants of hepatitis B infected women and the household or sexual contacts of hepatitis B infected individuals
• Uninsured or underinsured adults
• Fully insured individuals seeking vaccines during public health response activities including:
  • Outbreak response (regardless of insurance status)
  • Post-exposure prophylaxis
  • Disaster relief efforts
  • Mass vaccination campaigns or exercises for public health preparedness
  • Individuals in correctional facilities and jails (except as outlined in VFC Operations Guide)

A: The terms "underinsured" and "fully insured" are defined as follows:

• Underinsured: A person who has health insurance, but the coverage does not include vaccines or a person whose insurance covers only selected vaccines. Children who are underinsured for selected vaccines are VFC-eligible for non-covered vaccines only. Underinsured children are eligible to receive VFC vaccine only through a Federally Qualified Health Center (FQHC) or Rural Health Clinic (RHC) or under an approved deputization agreement.
• Fully Insured: Anyone with insurance that covers the cost of vaccine, even if the insurance includes a high deductible or co-pay, or if a claim for the cost of the vaccine and its administration would be denied for payment by the insurance carrier because the plan’s deductible had not been met.

A: Underinsured children who are seeking services in an FQHC or under a deputization arrangement are considered VFC eligible and therefore 317 vaccines may not be used. However, if the vaccines are being given at a healthcare facility that is neither an FQHC nor has it been deputized, then 317 funded vaccines can be used.

A: No. We encourage Awardees to incorporate third-party billing as part of their vaccination program and there are a number of Awardees working towards this in a variety of ways. Awardees exploring third-party billing should consider reaching out to other Awardees to understand options that will help facilitate this transition.

A: According to a presentation given by the AMA at the Adult Immunization Summit earlier this year, approximately 50% of plans had grandfathered status in 2011 with half of those expected to lose that status in 2012. Small plans are likely to lose grandfathered status quicker than large plans and it is estimated that 90% of grandfathered plans will lose their grandfathered status by 2014.

A: Awardees that have been working diligently to meet the October 1, 2012 deadline, but have specific issues that make compliance difficult can contact their CDC project officer to request technical assistance. Prior to requesting technical assistance, grantees should be sure to:

• Have a plan identifying all the steps necessary to reach compliance
• Updated the status of each of the action items showing efforts made
• Identify issues within the plan that will require assistance, type of assistance, etc.

A: The CDC has reached out to most of the Awardees and has not found state mandates that specifically require vaccination "for all" through federally purchased vaccine. Some states have guidance that if funding is available, this type of vaccination program should be pursued. 317 vaccine is not available for "vaccination of all." Individuals with insurance must obtain their vaccinations through their insurer’s provider network.

A: Each Awardee needs to develop policies that best fit their practices and their populations. However, the CDC recommends patient communications regarding this policy in the months leading up to the October 1st deadline to give individuals time to research and understand their insurance status. Recommended communications can include:

• Talking points for staff and clinicians
• Signage or video in patient waiting rooms, etc.
• Handouts

It is the provider’s responsibility to conduct diligent screening to ensure fully insured individuals are not receiving 317 vaccine. It is the individual’s responsibility to understand their insurance status and identify in network providers. It is our responsibility to communicate this to individuals effectively and ahead of the October 1st deadline to ensure they have the opportunity to understand their individual status.

A: No. Section 317 vaccine may not be used to routinely vaccinate any fully-insured individual. 317 vaccine may be used to vaccinate under-insured individuals whose insurance does not cover vaccination.

It should be noted that research done by the Kaiser Family Foundation indicates that individuals with high deductible health plans (HDHP) are a very small proportion of the insured population. Additionally, the study states that many HDHPs routinely cover preventative services without requiring the deductible is met. The CDC encourages awardees to contact insurers to determine their specific HDHP policies and benefits. The majority of covered workers with a deductible are in plans where the deductible does not have to be met before certain services, such as physician office visits, preventive care, or prescription drugs, are covered. Specifics from the report include:

• Roughly 84% of covered workers with general plan deductibles in HMOs, POS plans (68%), and PPOs (74%) are enrolled in plans where the deductible does not have to be met before physician office visits for primary care are covered
• Higher shares of covered workers do not have to meet the deductible before preventive care is covered in HMOs (96%), PPOs (93%), POS plans (88%), and HDHP/SOs (94%)

The Employer Health Benefits 2011 annual survey report can be found on the Kaiser Family Foundation web site.

The CDC recommends clear and consistent communication regarding the Section 317 vaccine policy to affected individuals in order to provide these individuals the time necessary to understand their specific insurance policy and plan for the future.

A: While this child is considered underinsured for the vaccines that are not covered, a private practice may not administer VFC vaccines in this instance because VFC eligibility rules require that underinsured children receive their vaccines from an FQHC or RHC, or in a local health department that has been deputized. Private practices should refer underinsured children to an FQHC or RHC or a deputized VFC provider.

Some states use a combination of 317 and state vaccine to allow private physicians to vaccinate underinsured children in their medical home. Please check with your state or local immunization program to see if you receive vaccines funded with 317 or state funds to give to underinsured children in your practice.

A: VFC rules prohibit the use of VFC vaccine for children whose health insurance covers the cost of vaccinations, regardless of deductible or if a claim for the cost of the vaccine and its administration would be denied for payment by the insurance carrier because the plan's deductible had not been met.

A: If children have full coverage for vaccines, they are considered insured and therefore the health department will not be able to vaccinate them with 317 funded vaccines. Providers should work directly with the individual insurance companies, where possible, to ensure adequate payment for life-saving vaccines. Additionally, inform your state immunization manager of those plans that do not have adequate reimbursement. CDC is working with America’s Health Insurance Plans (AHIP) on insurance issues and may be able to facilitate some technical assistance to help address those issues.

A: VFC and Section 317 may be used for the birth dose of hepatitis B. The CDC wants to ensure that important strides made in vaccination coverage are not compromised. Awardees may decide to use 317 vaccines for vaccinating fully insured newborns with the birth dose of hepatitis B; however awardees should also be aware that CDC may change this guidance and disallow this use at a later time.

A: American Indian and Alaska Native adults whose only source of healthcare is provided by an Indian Health Service, Tribal or Urban healthcare organization that does not provide an ACIP-recommended vaccine can receive 317 funded vaccine if the vaccine is otherwise not available because they are not insured. In addition, it is CDC’s understanding that the IHS Chief Medical Officer plans to send out a memo stating that IHS considers provision of all ACIP recommended vaccines to be a basic standard of care, and strongly encourage all sites to provide all routinely recommended vaccines.

A: Yes. If Medicaid does not cover Tdap or another vaccine for adults, the adult is considered underinsured for that vaccine and may receive 317 funded vaccines.

A: Medicare Part B does not cover certain vaccines, including Zoster, Tdap or Td. However, all Medicare Part D plans are required to cover ACIP-recommended vaccines not covered under Medicare Part B. Thus if the individual has both Medicare Part B and Part D, he/she is considered fully insured for vaccines and may not receive 317 funded vaccines. If the individual does not have Medicare Part D coverage, then he/she is considered underinsured for those vaccines and may receive 317 funded vaccines.

A: No. Tdap cocooning programs may not be funded with 317 vaccines. Vaccination of pregnant women and contacts of young infants, if part of pertussis outbreak response, may be conducted with 317 vaccine.

A: For the 2012-2013 influenza season, we have indicated that 317 vaccine funds may be used to support mass vaccination clinics, and 317 vaccine can be used to respond to disease outbreaks. It is important to clarify however, that we do not expect 317 vaccine funds will be used routinely for other school-based vaccination efforts.

A: Awardees are encouraged to use their FY 2012 Section 317 influenza vaccine for fall influenza outreach clinics even if they fall after the October 1 deadline.

A: If Medicare does not cover a vaccine for adults, the adult is considered underinsured for that vaccine and may receive 317 funded vaccines.

A: Many immigrants and refugees lack health insurance, making it hard for them to get the care they need. However, some refugees are eligible for SCHIP, Medicaid, or other special programs such as Refugee Medical Assistance. Awardees are encouraged to contact their State Refugee Program to determine their state policies on immigrant and refugee healthcare benefits. If the state does not provide immigrants and refugees with medical benefits through these programs and the individuals do not have employer sponsored health insurance, then they are considered uninsured and may be vaccinated with 317 funded vaccines.

A: Yes. Awardees that are moving towards purchasing vaccines off of the federal contracts for fully insured SCHIP children may use their Section 317 vaccines to provide a stock of vaccine for those children, as long as those vaccines are replenished with state funds in accordance with our policy. Please note that this only applies to non-direct ship vaccines.

A: Deputization is the extension of authority from Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) to other VFC providers to vaccinate underinsured VFC-eligible children. Extension of this VFC authority is intended to provide underinsured VFC-eligible children with access to VFC vaccines that would otherwise be unavailable due to limited capacity or absence of an FQHC or RHC in a service area.

Currently, more than 20 states have deputization arrangements between FQHCs/RHCs and local health departments.

A: Deputization is generally intended only for local health departments (LHDs). However, states may request deputization of non-public VFC providers, including private practices, in limited circumstances. In order for deputization to be approved, states must demonstrate the need to extend authority to other non-public VFC providers in order to serve underinsured children who face barriers to receiving VFC vaccine because of:

1. Geographic distance from an FQHC/RHC
2. Insufficient capacity of FQHCs/RHCs to serve the needs of the underinsured population
3. No LHDs or insufficient capacity of LHDs to be deputized to serve the needs of the underinsured population in their service areas