VFC Program Enrollment and Requirements 

1) Is the VFC enrollment specific to each birthing hospital within a health system, or is it applicable to the entire system as a whole?

Enrollment is specific to each hospital or clinic as they are kept separate for documentation/inventory accountability purposes. 

2) Once enrolled, will the facility be required to provide all vaccines to eligible patients or is this only for Beyfortus?

Facilities who enroll in VFC will only be required to carry the vaccines for the patient populations they serve. For birthing hospitals, they would only need to carry HepB and nirsevimab.

3) Once enrolled, can we order other vaccines from the VFC formulary? 

If your facility wishes to order additional products, you must be prepared to provide additional necessary information, such as population estimates and additional storage units (if a freezer is necessary for the product). 

4) What is the advantage of enrolling in the program versus continuing our existing practice of purchasing what we need and submitting for reimbursement through normal processes? Wouldn’t Medi-Cal reimburse the cost of the drug?

Medi-Cal would not reimburse for the cost of nirsevimab. It is expected that doses of nisevimab intended for medi-cal eligible babies are received from the VFC program 

5) Are there any plans to move away from the manual temperature logging requirements and rely on electronic temperature monitoring?

Unfortunately it is a strict CDC requirement that manual logs be used in addition to the digital data loggers. The purpose of this is to ensure the temperatures are being checked twice a day by a staff member, in case the DDL breaks and doesn’t send a notification. We are sensitive to the fact that pharmacists are working with these storage units on a 24/7 schedule. At this time, we are able to offer a fillable pdf of the manual temperature log so that it can be filled on an electronic device if that is preferred over printing a copy and filling it with pen and pencil. The temperatures must still be checked twice a day and documented on this form.

6) How are allocations awarded?

Based on available supply and eligible VFC populations, CDC will provide up-front allocations to states to begin ordering. 

7) What do hospital “audits” for VFC typically entail?

The VFC team words closely with all VFC providers. including birthing hospitals, to ensure that they feel supported. While we do have compliance visits, we always strive to lead with education. Our goal is to keep providers abreast of program requirements and expectations. We are always here as a resource. Our main objective is to keep providers enrolled in the program and offer support from the get-go. We don’t have a separate visit process or tool; it is a compliance visit.

8) Could we apply local restrictions or are we mandated to administer Beyfortus to all neonates as soon as they are born?

Enrolled facilities must follow VFC PRogram guidelines and administer doses to all eligible babies. 

9) Will Aeroscout constant temperature monitoring for the replacement model still need a manual temperature log?

Yes. Currently, we still require manual temperature logs regardless of the type of continuous temperature monitoring system in place, but we now have a fillable digital form to assist hospitals with work flows.

10) Would it be possible to keep track of how many neonates were qualified for the VFC program and submit the # at the end of the year?

Hospitals approved to enroll in VFC as a Vaccine Replacement Model may administer private doses of nirsevimab and submit replacement requests to VFC on a monthly basis.

11) If using the traditional model, what happens if a VFC stock was incorrectly used for a non-eligible patient? Can I simply replace the VFC dose with a purchased sotck? Are the lot numbers being tracked and reported out somewhere?

If this occurs, we will ask the site to move a dose from the other stock, report it to VFC, and then document the lot number. Proper training on stock labeling needs to occur. Stock separation within the unit and verification steps are strategies used to minimuze the potential inadvertent administration of the incorrect stock.

VFC Replacement Model 

11) What is the expectation for my hospital participating in the replacement model?

Have the ability to purchase vaccine doses and ability to supply privately purchase vaccines to vaccinate VFC-eligible children then participate in the replacement model.

12) How do we sign up for the replacement model?

First, you will need to enroll in the VFC program. Once your application is accepted, we will reach out with additional details about enrolling in the replacement model. 

13) Is the replacement model a replacement of product or reimbursement for private stock?

The replacement model is a replacement of doses administered to VFC eligible newborns.

Other Related Questions

14) Is there a defined RSV season like there is for flu?

Yes. In California, RSV season typically runs from October through March.

15) How is the supply situation looking like for the coming season? Can supply chain meet the patient needs yet?

Supply levels for nirsevimab are expected to support program needs. 

16) What is the anticipated timeframe from delivery? With the COVID vaccine, we had to anticipate well in advance and at times, did not receive our deliveries. 

For VFC, we currently do not have a timeline. For private doses, delivery depends if you complete reservation, as you may have early access to doses. But, Sanofi will be the best source for information. 

17) Do you know how VFC complies with the Drug Supply Chain Security Act (DSCSA)? CommonSpirit is requiring data feeds from our normal vendors to connect with Tracelink.

VFC is the purchaser of doses not distributor. So, DSCSA is not applicable.