Programs & Tools:
VFC: Frequently Asked Questions
Vaccines for Children Program Topics:
On This Page:
General Questions
Incorporation of new vaccines into the VFC Program
What is the process for including a new vaccine in the VFC program and how are immunization programs informed about the changes?
The Advisory Committee on Immunization Practices (ACIP) has the advisory role to determine what vaccines should be recommended for administration to children, adolescents, and adults in the U.S. and the operational role to approve which vaccines should be available through the VFC program. The ACIP meets three times a year, and during these meetings newly licensed vaccines may be discussed and recommended for use. Once a vaccine is recommended by ACIP, a vote is taken about whether or not to include the new vaccine in the VFC program through consideration of a VFC resolution. VFC resolutions are specific to each vaccine and include who is eligible to receive the vaccine, the vaccination schedule, and precautions or contraindications to the vaccine. Once the VFC resolution is approved, CDC must negotiate a contract for the vaccine to make it available under the VFC program. VFC resolutions are posted on CDC’s website.
Do CDC and grantees have any federal requirement to implement ACIP-recommended vaccines?
CDC and immunization programs that receive VFC funds are required to implement ACIP-recommended vaccines for which there are VFC resolutions and for which federal contracts have been established to purchase these vaccines. When using 317,
state and local funds for immunizations, implementation of all ACIP recommendations is not required.
VFC and Medicaid
Note: Included are several general questions related to VFC and Medicaid. Additional questions relevant to Medicaid are included in other sections of this web page (document) as well.
What is the 90-day VFC Medicaid rule?
Section 13631(g) of the Omnibus Budget Reconciliation Act of 1993 (OBRA ’93) provided that vaccination services covered under the Early and Periodic Screening Diagnostic and Treatment (EPSDT) benefit for Medicaid-eligible children will follow the ACIP-established VFC schedule beginning 90 days after establishment of the schedule. CMS considers the 90-day clock to begin on the publication date in the MMWR of ACIP general recommendations for use of a VFC vaccine. Check with the state Medicaid program or CMS for more information regarding the effective date of a new VFC vaccine requirement for EPSDT children and payment of administration fees for such Medicaid children.
Note: The 90-day rule does not apply to other categories of federally vaccine-eligible VFC children (i.e., uninsured, underinsured and American Indian/Alaska Natives). The VFC requirement for non-Medicaid federally vaccine-eligible children is effective on the effective date noted in the ACIP VFC resolution for a particular VFC vaccine or the date vaccine is first available through a CDC VFC contract, whichever is later.
Is Medicaid federally mandated to cover ACIP’s VFC-recommended vaccines for the Medicaid population?
Yes, all of ACIP’s VFC-recommended vaccines are part of the EPSDT benefit package for Medicaid children under age 21. Immunizations through age 18 years are covered by the VFC program. Children 19 years through 20 years are covered by Medicaid program funds.
Can a state require Medicaid providers to become VFC-program registered providers in order to ensure that Medicaid-eligible children receive vaccine under the VFC program?
Yes, the state Medicaid agency does have the option to require participation in the VFC Program.
VFC and Record-keeping
How long should VFC records be retained by a provider?
At minimum, the VFC program provider records must be kept for a period of three (3) years after service to the patient has been completed unless state law/policy establishes a longer archival period. Each state may have different rules regarding the retention of medical records, especially medical records of minor children. The two key agencies to check with regarding record retention rules are the state licensing board and/or the Secretary of State.
Is a faxed signature on the VFC Provider Enrollment form adequate for our records?
If a VFC staff member is unable to obtain the provider’s signature on the enrollment forms during the initial VFC enrollment site visit, then a signature on the faxed copy of the provider enrollment forms is acceptable for the VFC program records.
The number of records/charts reviewed can be based on the volume of patients seen from birth through 18 years by a provider. If a provider has 10 or fewer patients from birth through 18 years(both VFC and non-VFC eligible), charts for all 10 of those patients must be reviewed for documentation of screening for VFC eligibility. If a provider has 11 or more patients from birth through 18 years patients (both VFC and non-VFC eligible) the grantee has the option of determining the sample size. CDC requires that a minimum of 10 records/charts be reviewed for documentation of screening for VFC eligibility.
CDC recommends a sequential-based review, which involves using the appointment schedule and selecting the last X (sample size) patients who were 0 through 18 years of age and were seen for immunizations. Since the VFC requirement is to screen children at all immunization encounters (page 3, Module 3 [November 2007], VFC Operations Guide), anything less than full compliance (that is, identifying any chart that does not have documentation of screening) must be discussed with the provider and office staff and may require additional follow-up.
Appendix 6 of the VFC Operations Guide (August 2007) contains sample protocol and methodology based on a sample size of 30 records/charts. The grantee must have a written standardized protocol that all field staff follows on sample size, random records/charts selection, reviewing the records/charts and compiling results.
Could CDC provide guidance on how to follow-up with a provider that is not screening all pediatric patients for VFC eligibility? New
When it is discovered that a provider is not documenting the initial screening of all pediatric patients for VFC eligibility correctly, CDC’s non-compliance with VFC Provider Requirements protocol must be followed.
Please define the term “waive” in the context of this section of Module 3 (pages 5-6) of the VFC Operations Guide (November 2007):
4. Not deny administration of a federally purchased vaccine to an established patient because the child's parent/guardian/individual of record is unable to pay the administration fee.
Note: The term “established patient” applies only to private providers enrolled in the VFC program. CDC considers public providers the safety net providers for the VFC population and they must administer VFC vaccine to any VFC-eligible children who present for immunization services at their facilities.
Provider Education Goals for this requirement:
By the end of the enrollment or education session the provider and staff will understand
- This requirement applies to VFC vaccines as well as any other vaccines purchased through the CDC federal contracts when the eligible child's family/guardian is unable to pay the administration fee;
- The only fee that must be waived is the administration fee. Other visit or office fees may be charged as applicable. New
The term “waive” in this context is based on the first entry of "waive" as defined in the online version of Merriam-Webster dictionary #1). 1 give up, forsake. So, if the parent cannot pay the administration fee for a VFC vaccine, the provider must give up or forsake the VFC administration fee. The collection of the payment for the administration fee cannot be deferred until a later date/time.
Vaccine Administration Fees
What are the statutory requirements for the VFC program regarding the vaccine administration fee?Section 1928(c) (2) (C) (ii) of the Social Security Act (42 U.S.C. 1396s(c) (2) (C) (ii)) states:
"The provider may impose a fee for the administration of a qualified pediatric vaccine so long as the fee in the case of a federally vaccine-eligible child does not exceed the costs of such administration (as determined by the Secretary based on actual regional costs for such administration)."
Section 1928(c) (2) (C) (iii) of the Social Security Act (42 U.S.C. 1396s(c) (2) (C) (iii)) further provides that: "The provider will not deny administration of a qualified pediatric vaccine to a vaccine-eligible child due to the inability of the child's parent to pay an administration fee."
The Health Care Financing Administration (HCFA), now the Centers for Medicare and Medicaid Services (CMS), published a notice of the federal regional administration fee caps in the Federal Register on October 3, 1994 (59 FR 50235). The notice also indicated that state Medicaid programs could establish lower administration fees for VFC vaccination of Medicaid children. Except in the case of an inability to pay, the notice further stated that VFC providers can charge non-Medicaid federally vaccine-eligible children (i.e., uninsured, American Indian/Alaska Natives, and when administered by an FQHC or RHC, underinsured children) up to but not more than the maximum regional administration charge (if that charge reflects the provider's cost of administration) regardless of whether the state has established a lower administration fee under the Medicaid program.
The administration fee caps do not apply to vaccination of state vaccine-eligible children. The VFC program does not have any authority over administration fees charged to state vaccine-eligible children or privately insured children.
For example:
State A’s Medicaid Agency has set the state Medicaid vaccine administration reimbursement at $10.00. The state’s regional administration fee cap is $15.00. A VFC-enrolled provider can expect to receive $10.00 for the administration of a vaccine to a VFC-eligible child enrolled in Medicaid. The VFC-enrolled provider can charge a maximum of $15.00 to a VFC-eligible child NOT enrolled in Medicaid. The VFC program does not regulate administration fees charged to private pay or privately insured patients.
What group(s) of VFC eligible children can be charged an administration fee?
VFC providers can charge an administration fee directly to the parents of non-Medicaid VFC eligible children (i.e., uninsured, American Indian/Alaska Natives and underinsured children).
VFC providers can charge non-Medicaid federally vaccine-eligible children up to but not more than the maximum regional administration charge.
Who should pay the vaccine administration fee for Medicaid-eligible children?
The state Medicaid agency should be billed for the administration fee for Medicaid-eligible VFC children immunized by a Medicaid-enrolled VFC provider. State Medicaid agencies establish their own policies and administration fees that may be lower than the regional maximum charges established in 1994. For Medicaid VFC-eligible children, the state Medicaid agency determines and CMS approves the reimbursable amount for their fee-for-service and managed care enrolled recipients. If the provider bills Medicaid the regional maximum charge instead of the Medicaid agency’s allowable rate the provider will be reimbursed only the allowable rate and not the amount billed. The difference between the allowable rate and the amount billed cannot be collected from the parents of the child.
What are the administration fee requirements for insured children who have private health insurance benefits that include immunization coverage?
The VFC administration fee caps only apply to VFC eligible children and do not apply to privately insured children.
What is involved in raising the reimbursement rate for VFC vaccine administration by Medicaid at the state level?
State Medicaid agencies, through processes that vary from state to state, may raise the VFC administration fees payable to Medicaid providers for vaccinating Medicaid eligible children up to the regional fee cap that was established for each state in 1994. Should a state consider its CMS-imposed cap to be too low, CMS and CDC should be contacted to discuss potential revision of the fee cap. Because so few state Medicaid agencies are reimbursing at the maximum regional charge, the current fee structure will remain in effect until further notice.
Is the administration fee based on per shot or per antigen?
Providers bill according to CPT codes that are based on each vaccine (type of immunization) administered. Reimbursement through Medicaid varies by state. Some state Medicaid agencies reimburse a vaccine with multiple antigens at a higher rate than a single antigen vaccine. Some states limit the amount of administration fees reimbursed per visit. Please check with the state Medicaid agency to determine how the VFC administration fees are reimbursed. State Medicaid agencies cannot eliminate reimbursement of an administration fee because of how the vaccine is administered (i.e. injection versus orally administered). For non-Medicaid VFC eligible children (i.e., Alaska Natives/Native Americans, uninsured and underinsured) the administration fee is based on vaccine dose (shot)not the number of antigens contained in a vaccine dose (shot). The administration fee charged to a non-Medicaid VFC eligible child cannot exceed the maximum regional charge except in universal-purchase states and then only if certain conditions are met. See the next question.
How does the CMS maximum regional charge for vaccine administration relate to universal-purchase states?
The October 1994 Federal Register notice gives universal purchase states (states in which the vaccines are purchased by the state for all children in the state) the right to develop administration fees that differ from those established by CMS, provided they are reasonable. Therefore, universal purchase states are provided the flexibility to accept the maximum charges established by the Secretary or develop their own maximum charges. The maximum charges must be developed utilizing a reasonable methodology based on VFC section 1928(c)(2)(C)(ii) of the Social Security Act. The amount of the cap (maximum fee) is not required to be set in state law. However, the authority to set an amount must be based in state law. In either case, CMS gives state Medicaid agencies the option to establish and apply vaccine administration fees that are lower than the specified maximum regional charges if they provide assurances that Medicaid children have access to immunizations to the same extent as the general population.
How does a VFC-enrolled provider who is not already a Medicaid provider file for Medicaid reimbursement for vaccine administration?
It is necessary to be a Medicaid provider in order to receive payment from Medicaid for vaccine administration services provided to Medicaid-eligible children. Providers should consult the state Medicaid agency about the procedures necessary to become a Medicaid provider.
Does the VFC program require that a sign be posted in all vaccine providers’ offices that states “No VFC eligible child may be denied federally-supplied vaccine due to the inability to pay the administration fee”? May we use some other communication tools, such as a flyer that allows for a few paragraphs of explanation?
There is nothing in the VFC legislation that mandates a posted sign in provider offices. Other means of communication may be used.
Can a private provider refuse to administer VFC vaccine to VFC-eligible child?
Section 1928 (c)(2)(C)(iii) of the Social Security Act states, “The provider will not deny administration of a qualified pediatric vaccine to a vaccine-eligible child due to the inability of the child’s parents to pay an administration fee.” The statute further notes at Section 1928(c)(2)(C)(i) that "A program-registered provider is not required under this section to administer such a vaccine to each child for whom an immunization with the vaccine is sought from the provider." CDC interprets this to mean that private VFC providers, unless otherwise required by another statute, do not have to honor vaccine requests by VFC-eligible children who “walk in” for immunizations only and are not established patients in the practice. For established VFC-eligible patients and other VFC-eligible patients that the provider chooses to immunize, VFC immunization can not be denied due to the inability to pay an administration fee."
VFC Eligibility
How is the term “VFC eligible” defined?
Children through 18 years of age who meet at least one of the following criteria are considered federally vaccine-eligible and therefore eligible to participate in the VFC program:
- Medicaid eligible: A child who is eligible for the Medicaid program.(For the purposes of the VFC program the terms Medicaid-eligible and Medicaid-enrolled are equivalent and refer to children who have health insurance covered by a state Medicaid program)
- Uninsured: A child who has no health insurance coverage
- Indian (American Indian or Alaska Native): As defined by the Indian Health Care Improvement Act (25 U.S.C. 1603)
- Underinsured: Children who have commercial (private) health insurance but the coverage does not include vaccines, children whose insurance covers only selected vaccines(VFC - eligible for non-covered vaccines only), or children whose insurance caps vaccine coverage at a certain amount-- once that coverage amount is reached, these children are categorized as underinsured. Underinsured children are eligible to receive VFC vaccine only through a Federally Qualified Health Center (FQHC) or Rural Health Clinic (RHC).
How does “Medicaid enrolled” differ from “Medicaid eligible”?
For the purposes of the VFC program both terms, “Medicaid enrolled” and “Medicaid eligible,” are equivalent and refer to children who have health insurance covered by a state Medicaid program.
How can you determine if a health benefits organization is a health insurance company when determining a child’s VFC eligibility?
Health insurance is subject to t he Employee Retirement Income Security Act of 1974 (ERISA) or is regulated by a state’s Insurance Commissioner as insurance. ERISA is a federal law that sets minimum standards for most voluntarily established pension and health plans in private industry to provide protection for individuals in these plans. Contact the state Insurance Commissioner to determine if an organization is a health insurance company.
If a family has a medical savings account or health savings account does that account affect a child’s VFC eligibility?
Individuals covered by medical savings accounts or health savings accounts must also have high deductible health plan coverage. Therefore, such individuals are insured.
The 2002 VFC Operations Guide states that underinsured children are eligible to receive VFC vaccine only if they are served by an FQHC or RHC. What is the definition of "served by?
In the VFC program, “served by” means that underinsured children are seen in or under the auspices of an FQHC or RHC to obtain the VFC vaccine.
If a child presents for vaccines and does not have health insurance but the parent plans to insure the child, would this child be eligible for VFC vaccine?
If the child has no health insurance on the day he/she presents at the office for immunizations, the child would be VFC eligible because he/she is uninsured. VFC eligibility screening must take place with each visit even though the patient screening form needs to be updated only when the eligibility status of the child changes.
If a child is eligible for insurance and the parents choose not to insure the child, would the child be eligible for VFC vaccine?
If the child has no health insurance on the day he/she presents at the office for immunizations, regardless of the reason, the child would be VFC eligible because he/she is uninsured.
Can VFC vaccines be administered to the underserved population?
VFC does not have a category specifically for the underserved. The term “underserved” refers to a geographic location such as a county or a census tract or a population living in a specific geographic location that has been designated by HRSA as medically underserved. For further information on medically underserved areas or population, please visit the Health Resources and Services Administration (HRSA) website at http://www.bhpr.hrsa.gov/shortage/muaguide.htm (exit)
It is common for VFC-eligible children to live in medically underserved areas or to be members of medically underserved populations.
If a child is eligible for a Title V program that pays for medical care for that child, is the child VFC eligible?
Title V is not a type of health insurance so it has no effect on VFC eligibility of a child. To be eligible for VFC a child has to meet the age and eligibility criteria of the VFC program. To learn more about the Title V program see the HRSA website: https://perfdata.hrsa.gov/mchb/mchreports/Search/search.asp (exit)
Are all children enrolled in Medicaid programs automatically VFC eligible?
Yes, all children from birth through 18 years of age who are covered by Medicaid are considered VFC eligible because of their Medicaid status.
Are all children who have Medicaid as a secondary insurance covered by VFC?
Yes, all children who have Medicaid as a secondary insurance are covered by VFC. The state Medicaid agency will pay the claim for the administration fee and seek reimbursement from the primary insurance.
How should providers bill administration fees for VFC vaccines administered to children who are covered by Medicaid and have another form of health coverage?
If a VFC-eligible child starts a vaccine series (such as hepatitis B) at age 18, can the series be completed using VFC vaccine after the child turns 19?Generally, providers are required to bill third parties before Medicaid will make payment (we refer to this as cost avoidance). However, there are a few exceptions to the cost avoidance rules. In the case of preventive pediatric services including EPSDT, if the Medicaid agency is billed, it is required to make payment and then seek reimbursement from the third party (CMS refers to this as pay & chase) - see 1902(a)(25)(E) of the Social Security Act. The Medicaid agency is to seek recovery as long as it is cost effective to do so, i.e., where the amount of reimbursement the State can reasonably expect to recover exceeds the cost of recovery (see 1902(a)(25)(B)). Since child immunizations fall under this exception, the provider has several options for billing the administration fee:
The provider could bill the Medicaid agency first and Medicaid would be responsible for seeking reimbursement from the primary insurance The provider could bill the primary insurance.
If the primary insurance is billed first and the insurance denies the claim, the provider could then bill the administration fee to Medicaid. The Medicaid agency should bypass their cost avoidance edit allowing the claim to be considered for payment.
Also, if the third party payer pays less than the Medicaid amount, the provider can bill Medicaid for the balance up to the amount Medicaid pays.
No. Children are eligible to participate in the VFC program only through age 18 years regardless of the child’s immunization status (series completed or series not completed) when they age out of VFC.
Can juveniles who are incarcerated and lose access to their health insurance be considered uninsured and be served with VFC vaccine?
Yes, an individual who loses access to benefits under his/her insurance while incarcerated is uninsured for purposes of the VFC program.
If an unaccompanied minor without knowledge of insurance status presents in family planning clinic (e.g. Title X clinic, Planned Parenthood or STD) would that child be considered VFC eligible?
A person under 19 years of age who may have insurance but because of the confidential circumstances for seeking services does not have access to that insurance coverage is uninsured for the purposes of the VFC program. The Family Planning clinic must screen these adolescents for VFC eligibility using the form: Patient Eligibility Screening Record Vaccines for Children Program for Family Planning Clinics”. In addition, each Family Planning clinic must document all VFC vaccines administered to unaccompanied minors without insurance information on the administration log titled “Family Planning Clinic Unaccompanied Minor without Insurance Information VFC Vaccine log”. The completed logs should be submitted to the immunization program on a monthly basis. Both documents are available at the end of this questions and answers document.
Note: The VFC program in no way regulates the issue of medical consent for the provision of medical care to minors. The assumption is that the clinic provides any such care in conformance with the state’s medical consent laws as they pertain to minors.
Other than age and not meeting at least one of eligibility requirements for the VFC program are there any other factors that would make a child ineligible to receive vaccine through the VFC program?
No. As long as the child is under 19 years of age and meets at least one of the following eligibility criteria: enrolled in Medicaid, uninsured, American Indian/Alaska Native, or underinsured (can only receive VFC vaccine through a FQHC or RHC) the child is eligible to participate in the VFC program. No other factors can be considered when screening children for eligibility for participation in the VFC program (e.g. residency status or family income).
If an American Indian/Alaska Native has insurance that covers vaccines (full or partial) is the child still eligible for VFC vaccine?
Yes, American Indian/Alaska Native are eligible to participate in the VFC program regardless of insurance coverage.
No, these children are considered to be insured for the purposes of the VFC program and are not eligible to receive VFC vaccine.
Vaccine Storage and Handling
Where can I get more information on vaccine cold storage and handling?
CDC’s Vaccine Storage and Handling Toolkit is available on-line. The link to download the toolkit is http://www2a.cdc.gov/vaccines/ed/shtoolkit/default.htm.
What is the impact of a power outage on vaccine and what should be done with vaccine?
General procedures for power outages are described in Chapter 7 of the Vaccine Storage and Handling Tool Kit
All providers should have an Emergency Vaccine Retrieval and Storage Plan Worksheet
Note: The following key messages for immunization providers. In any type of power outage:
- Do not open freezers and refrigerators until power is restored, except to transport vaccine to an alternative storage location.
- Monitor temperatures and duration of power outage; don’t discard vaccine; don’t administer affected vaccines until you have discussed with public health authorities.
What is CDC’s policy regarding the use of certified thermometers and the expectation in terms of frequency of re-calibrating thermometers?
The VFC Site Visit Questionnaire requires a practice to have one certified thermometer per refrigerator or freezer compartment and requires that this thermometer be used for recording temperatures If there is not a certified thermometer at the time of the VFC site visit in any or all of the vaccine storage units, then corrective action must be taken by the office to correct the situation, and the corrective action steps must be monitored by the grantee.
In the Vaccine Storage and Handling Toolkit, CDC recommends the use of refrigerator and freezer thermometers that have been individually certified against an ASTM or NIST standard. Additional information about thermometers is available in the Vaccine Storage and Handling Toolkit at http://www2a.cdc.gov/vaccines/ed/shtoolkit/default.htm.
Manufacturer specifications should be followed regarding recalibration, or recertification of thermometers. The manufacturer-specified frequency of recalibration varies by make and model, with recalibration every 1-2 years being typical. This should be considered as part of the overall cost when purchasing thermometers.
Graphing thermometers with moving parts and frequent pen/paper changes are likely to become less accurate with time. Comply with the manufacturer’s recalibration schedule. Digital thermometers may also become less accurate with time; however, these are relatively inexpensive, and may be less expensive to replace than to recalibrate. Bottle-type thermometers, which have no mechanical or electronic parts, are most likely to remain accurate for extended periods, and may be less expensive to replace than to recalibrate. However, bottle-type thermometers may be rendered inaccurate if the liquid column separates.
Grantees must set their own policies regarding which types of thermometers are acceptable and their recalibration requirements. Recalibration and recertification requirements should take into account manufacturer specifications and guidelines.
When a grantee checks the accuracy of thermometers at site visits, the following should be considered:
The frequency of site visits. If a provider is visited only once in four years, it may be some time before an inaccurate thermometer is identified. This can also make evaluation of past temperature logs difficult in the event that temperatures fall outside the recommended ranges.
The recertification of reviewer thermometers. If these will be used as standards for comparison, they should be recertified according to the manufacturer’s recommended schedule.
The relative accuracy of thermometers. Nearly all thermometers will have some variance in accuracy (generally +/- one degree). The grantee should define the acceptable variance before recalibration or replacement is required.
What type of storage equipment does the VFC program require enrolled providers to have to keep VFC vaccine in their practices?
Are “Dorm Style” refrigerators acceptable storage units for VFC vaccines?VFC providers must have appropriate equipment that can store and assist with maintenance of proper conditions of vaccines.
Vaccine storage units must be selected carefully and used properly. If a provider does not have the appropriate storage units, the grantee must work with the provider to obtain storage units that are acceptable.
Refrigerators without freezers, and stand-alone freezers, may be better at maintaining the required temperatures. However, a combination refrigerator/freezer unit sold for home use is acceptable for vaccine storage if the refrigerator and freezer compartments each have a separate external door.
Refrigerators or freezers used for vaccine storage must comply with the following requirements:
- Be able to maintain required vaccine storage temperatures year-round;
- Be large enough to hold the year's largest inventory;
- At a minimum, have a working certified thermometer inside each storage compartment. Grantees may require VFC providers to have a calibrated certified thermometer inside each storage compartment. Calibration must be traceable to standards provided by the National Institute of Standards and Technology (NIST) (a U.S. Government agency within the Commerce Department) or a laboratory recognized by NIST. Calibration can be traceable to NIST using American Society for Testing and Materials (ASTM) methods for the calibration process;
- Be dedicated to the storage of vaccines. (Food and beverages must not be stored in a vaccine storage unit because this practice results in frequent opening of the door and destabilization of the temperature.)
Reference: VFC Operations Guide - Module 6 pages 8-9, VFC Questions and Answers Document
Dormitory-style refrigerators should only be used to store a clinic's single-day supply of refrigerated vaccines and these vaccines should be returned to the main refrigerator storage unit at the end of each clinic day. Dormitory-style refrigerators are not adequate for long-term or permanent storage of biological products because they do not maintain appropriate temperatures.Storage of VFC vaccine in refrigerators that are designed for use in small household spaces such as dorm rooms are never acceptable for permanent storage of VFC vaccines. Permanent storage is defined as the vaccine supply is maintained in the unit 24 hours a day/7 days a week.
“Dorm Style” refrigerators are acceptable for short-term storage of select VFC vaccines under very limited conditions which are listed below:
- The purpose of using these units is for temporary storage when it is not reasonable for the staff administering the vaccine to go to the main storage unit to obtain vaccine for each and every patient.
- The unit is never used for storing Varicella-containing vaccines
- Only small amounts of inactivated vaccines can be maintained in these units. The amount of inactivated vaccines stored in the unit must never exceed the amount used in the clinic in one day.
- The vaccine is returned to the main storage unit at the end of each clinic business day and vaccine is never stored in these units overnight or during periods of time when the practice is not open for business.
- Each unit has a dedicated certified thermometer in place.
- Temperatures are monitored and documented twice a day on temperature log specifically for that unit. Appropriate action is immediately taken when the temperatures are outside the appropriate range.
- These units must be included and examined during the VFC compliance visit and corrective actions taken and documented by the grantee if any of the above conditions are not met.
Some of our providers have small compact storage units that were designed to hold medical biologicals. Are these storage units acceptable for permanent storage of VFC vaccine?
Yes, these types of vaccine storage units are acceptable if they meet the following conditions:
- The refrigerator and freezer compartments each have a separate external door, or
- Units are stand-alone refrigerators and freezers
Refrigerators or freezers used for vaccine storage must comply with the following requirements:Reference: VFC Operations Guide - Module 6 pages 8-9, VFC Questions and Answers Document
- Be able to maintain required vaccine storage temperatures year-round;
- Be large enough to hold the year's largest inventory;
- At a minimum, have a working certified thermometer inside each storage compartment. Grantees may require VFC providers to have a calibrated certified thermometer inside each storage compartment. Calibration must be traceable to standards provided by the National Institute of Standards and Technology (NIST) (a U.S. Government agency within the Commerce Department) or a laboratory recognized by NIST. Calibration can be traceable to NIST using American Society for Testing and Materials (ASTM) methods for the calibration process;
- Be dedicated to the storage of vaccines. (Food and beverages must not be stored in a vaccine storage unit because this practice results in frequent opening of the door and destabilization of the temperature.)
How does CDC define a dorm-style refrigerator?
A dorm-style refrigerator is a small combination refrigerator/freezer unit that is outfitted with one external door, an evaporator plate (cooling coil) which is usually located inside an ice-maker compartment (freezer) within the refrigerator, and is void of a temperature alarm device. Its temperature control sensor reacts to the temperature of the evaporator rather than the general air in the storage compartment. When the compressor is on, the evaporator cools to lower the temperature in the refrigerator, in most cases to below 0°C.The problem with dorm-style refrigerators is that they place vaccine at a high risk of freezing.
Ideally, vaccine storage units should be temperature-monitored/alarm-equipped stand-alone refrigerators and stand-alone freezers. These units, unlike the dorm-style units, will have an evaporator that is located behind the surface of the walls, the back of the refrigerator compartment or, in most cases in the back of the unit.
What type of guidance can be given to a VFC enrolled provider who is using small refrigerator that falls into CDC’s definition of a dorm-style refrigerator that has maintained the appropriate temperature according the provider’s log and the field staff’s thermometer regarding why the office must replace the unit?
The field staff should educate the provider that while this unit has performed well, these types of units are not reliably maintain temperatures needed to keep vaccine safely within the required ranges to prevent unintentional loss of vaccine because it was stored at inappropriate temperatures. CDC has never recommended that these small dorm-type refrigerators be used as permanent storage units for VFC vaccine. In 2008-2009, CDC is requiring all VFC programs to work with their enrolled VFC providers to eliminate the use of dorm-style refrigerators as permanent storage units for VFC vaccine. Grantees must plan to have all dorm-style refrigerators phased-out of currently enrolled VFC-provider offices by December 31, 2009. Grantees must work with providers that have these units so the transition to acceptable VFC vaccine storage units will be completed by December 31, 2009. Effective immediately, all newly enrolling VFC providers cannot use a dorm-style refrigerator as a permanent storage unit for VFC vaccine, please refer to VFC Operations Guide Module 6 pages 8-12 for further information on VFC program vaccine management requirements. One of the main reasons that CDC is taking this action is due to the rising cost of VFC vaccine. As VFC vaccine cost approaches $3 billion, it is essential for the integrity and continuation of the VFC program to ensure that VFC vaccine is stored in appropriate units which decrease the chance of vaccine loss due to inappropriate storage conditions. When possible, the field staff should share with provider the monetary amount that the VFC vaccine represents in that specific practice to further illustrates the need to store and manage the vaccine appropriately.
It appears that some manufacturers’ package inserts and CDC’s storage and handling recommendations for refrigerated vaccines differ by one degree on the bottom of the refrigerated range. What range should the field staff use as their guide?
Merck, GSK and Wyeth's package inserts recommend storage temperatures for their products to be 2° - 8°C (36° - 46°F). On the other hand, Sanofi's package inserts state that their products should be stored at 2° - 8°C (35° - 46°F). I have spoken with both the manufacturers and FDA on this matter. This is a non-issue with the manufacturers. In addition, the FDA (CBER's Office of Vaccine Research and Review (OVRR)) does not have any official position on this rounding issue. However, it is the opinion of OVRR that four-tenths of a degree should not cause any problem with the quality of vaccines and 35°F is acceptable. As you know, the vaccines should not be exposed to freezing temperatures, particularly those vaccines containing aluminum adjuvants. The take home message is that the recommended temperature ranges are effective in keeping vaccine storage away from the dreaded 0°C (32°F).
Celsius °C Fahrenheit °F 0 °C 32.0 °F 1 °C 33.8 °F 2 °C 35.6 °F 3 °C 37.4 °F 4 °C 39.2 °F 5 °C 41.0 °F 6 °C 42.8 °F 7 °C 44.6 °F 8 °C 46.4 °F
Some of our providers have been removing VFC vaccine that comes in manufacturer prefilled syringes from the original packaging to store in plastic containers if storage space is a concern. What is CDC’s position on this? new
CDC’s position is to have providers store vaccine in their original containers to help protect the vaccine from damage due to storage errors. As well as, to decrease the possibility of administration errors from inadvertently confusing similarly packaged vaccines.
VFC Provider Enrollment
Must a provider have an initial VFC enrollment site visit to become a VFC- enrolled provider?
Yes, VFC program staff are required to make an initial VFC enrollment site visit to a provider who is enrolling in the VFC program. The enrollment visit ensures that the provider and office staff are educated on the VFC program requirements and have the appropriate resources to implement the VFC program requirements and that the necessary paperwork is completed including the provider enrollment form and provider profile. If the provider enrollment form and provider profile cannot be completed at the time of the enrollment visit a date should be agreed upon with the office when the competed paperwork will be returned to the VFC program. The enrollment visit would not include the administration of the VFC Site Visit Questionnaire.
When should the first VFC site visit be made to administer the VFC Site Visit Questionnaire to monitor a newly enrolled VFC provider’s compliance with the VFC program requirements?
At a minimum, three months should pass between the initial enrollment visit and the first VFC site visit to administer the VFC Site Visit Questionnaire. It is important that enough time has passed between the enrollment visit and administering the VFC Site Visit Questionnaire that the provider has had time to document required activities such as initial screening for VFC eligibility and documentation of temperature logs. CDC recommends that the VFC program staff administer the VFC Site Visit Questionnaire for the first time between three to twelve months after the enrollment process is completed to assure that all high priority questions in the VFC Site Visit Questionnaire can be administered and answered accurately.
Can states make additional requirements for provider enrollment into the VFC program such as requiring AFIX visits or use of the registry?
No, states may not impose additional requirements for enrollment without prior approval from CDC. In addition, grantees must create their own provider enrollment form; however, any form must include the 9 federal enrollment requirement listed in Module Three, Provider Recruitment and Enrollment of the VFC Operations Guide.
Who can enroll in the VFC program?
The VFC statute follows state law in qualifying practitioners as VFC providers. The term “authorized for administration of pediatric vaccines” used in Section 1928(c)(1) (A) of the Social Security Act (42 U.S.C. 1396s (c)(1)(A)) is intended to mean authorized to prescribe vaccines. Therefore only health care providers authorized to prescribe vaccines under state law should be listed as the official VFC program registered providers. All additional providers should be listed on the Provider Enrollment form under “Additional Providers in the Practice.” The licenses and provider numbers for these additional providers must be listed on the enrollment form.
What should we do if a VFC-enrolled primary care provider does not want to order or offer one specific VFC vaccine based on his or her medical judgment?
The VFC statue, at section 1928(c)(2)(B)(i) of the Social Security Act (42 U.S.C. 1396s(c)(2)(B)(i)), states within the provider agreement section that the provider agrees as follows:
“Subject to clause (ii) the provider will comply with the schedule, regarding the appropriate periodicity, dosage, and contraindications applicable to pediatric vaccines, that is established and periodically reviewed and, as appropriate, revised by the…[ACIP], except in such cases as, in the provider’s medical judgment subject to accepted medical practice, such compliance is medically inappropriate.” CDC interprets this provision to mean a medical judgment based on the situation of an individual VFC patient. Except as noted in the next Q and A regarding varicella vaccine, only specialty providers may choose, at the discretion of the grantee, to offer only specific VFC vaccines and their choice is based on the scope of their medical practices. Other VFC providers must offer the full list of VFC vaccines according to the schedule determined by the ACIP in its VFC resolutions, except when in the provider’s medical judgment, subject to accepted medical practice, the circumstances of an individual VFC patient makes such vaccination medically inappropriate.
Our state has large rural areas and many rural providers do not have the appropriate storage units to stock varicella vaccine and may be the only medical provider for several hundred miles. Are these providers non-compliant with the provider agreement for the VFC program because they are not offering a specific VFC vaccine?
Certain vaccines, such as varicella vaccine, require special storage and it would be accepted medical practice not to order or store those vaccines if the provider did not have the appropriate storage facilities. We encourage grantees to assist providers in finding ways to obtain vaccine storage that will allow provision of all VFC vaccines.
Must specialty providers offer all age appropriate VFC vaccines to their VFC-eligible patients in order to enroll in the VFC program?
Specialty providers, at the discretion of the grantee, may limit their VFC practice to particular relevant vaccines.
When enrolling a birthing hospital in the VFC program is it necessary to list all providers (e.g. nurses, residents, interns) authorized to administer vaccines under the supervision of the VFC provider who signs the enrollment form?
No. Due to the potentially large number of individuals that would be listed and on the form and the difficulty in maintaining the accuracy of the list it is not necessary to list these individuals on the enrollment form for birthing hospitals.
Family Planning Clinic Documents
-
Patient Eligibility Screening Record Vaccines for Children Program for Family Planning Clinics
-
Family Planning Clinics Unaccompanied Minor without Insurance Information VFC Vaccine log
VFC Associated Web Site Resources
-
General VFC Information
http://www.cdc.gov/vaccines/programs/vfc/default.htm
http://www.cdc.gov/vaccines/programs/vfc/projects/default.htm#faq -
Excise Tax Credits
http://www.cdc.gov/vaccines/programs/vfc/forms/excise-tax.htm
- Storage and Handling
- Vaccine Contracts Guidelines
http://www.cdc.gov/vaccines/programs/vfc/downloadsguide-vac-contracts-508.pdf
(Temporarily pulled from site while it is being updated) - Early Periodic Screening Diagnosis and Treatment (EPSDT) Services
Note: For further information or clarification on VFC programmatic questions please contact: Nancy Fenlon @ ncf1@cdc.gov or 404-639-8810.
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 January 2, 2008
Content Source: National Center for Immunization and Respiratory Diseases
