FAQs for Private and Public Healthcare Providers About Implementing the CDC COVID-19 Vaccination Program in Provider Practices

As a healthcare provider, you play a critical role in helping to end the COVID-19 pandemic. For patients, you are one of the most trusted sources of information when it comes to vaccines. Patients may have questions and concerns about COVID-19 vaccines. You can help them understand the importance of vaccination, provide your strong recommendation, and build confidence in vaccines. Strong vaccine confidence leads to more people getting vaccinated, which leads to fewer COVID-19 illnesses, hospitalizations, and deaths.

Learn more about:

• Vaccinate with Confidence
• Vaccine Recipient Education

To become a COVID-19 vaccination provider, you must be licensed to administer vaccines in the jurisdiction where you will be practicing. Your health system or you, as an independent provider, are required to sign and abide by the terms of the CDC COVID-19 Vaccination Program Provider Agreement. The agreement requires that you follow best practices for storing, handling, and administering vaccine and that you collect and report certain vaccination-related information. For more information about the requirements for enrolling in the CDC COVID-19 Vaccination Program, see How to Enroll as a COVID-19 Vaccination Provider or contact your state or local immunization program.

No. COVID-19 vaccines are provided at 100% no cost to the vaccine recipient. COVID-19 vaccination providers cannot charge vaccine recipients for the vaccine (which is provided free to enrolled providers by the U.S. government) or for any administration fees, copays, or coinsurance. COVID-19 vaccination providers cannot deny vaccination to anyone who does not have health coverage, is underinsured, or is out of network.

COVID-19 vaccination providers cannot charge recipients for an office visit or any other fee if the only service provided is a COVID-19 vaccination. Additional healthcare services can be provided at the same time and billed as appropriate. However, providers cannot require additional services for a person to receive a COVID-19 vaccine.

If a vaccine recipient has health coverage, providers may seek appropriate reimbursement from the recipient’s plan or program (e.g., private health insurance, Medicare, Medicaid) for a vaccine administration fee. However, providers cannot bill the recipient for the balance not covered by the recipient’s plan or program. For further information on reimbursement requirements, please see the CDC COVID-19 Vaccination Program Provider Requirements and Support webpage.

If you are a private provider, you are not required to provide vaccination to anyone who is not currently a patient. However, CDC strongly encourages, when possible, that providers make vaccine available to others in their local communities, including patients’ family members. Pharmacies, public health clinics and any clinics held in communities are required to offer vaccination to anyone who is eligible.

Yes, all providers participating in the program are required to sign a COVID-19 Vaccination Provider Agreement. As a VFC provider, you will have already implemented or be familiar with many of the requirements of the program, including ordering vaccine and reporting to your jurisdiction’s immunization information system (IIS). You may also have already completed some of the training recommended to become a COVID-19 vaccination provider.

CDC offers a variety of training resources for preparing and administering COVID-19 vaccines. Visit Training and Education for COVID-19 Vaccination for training information and core competencies for healthcare professionals. At a minimum, CDC recommends all providers complete the training module for the vaccine(s) they will be administering. The training modules can be found at  COVID-19 Vaccine Training Modules. Additional vaccine preparation and administration resources can be found on CDC’s web pages for each vaccine product at U.S. COVID-19 Vaccine Product Information. Your state, local, or jurisdictional immunization program may also have training requirements.

Providers who are enrolled in the VFC program may already have completed some of the training recommended to become a COVID-19 vaccination provider.

Each COVID-19 vaccine has its own storage and handling requirements. As a COVID-19 vaccination provider, you are required to ensure vaccines are maintained within proper temperature ranges by using a digital data logger (DDL) to monitor vaccine storage unit temperatures and recording temperatures daily. Additional details are available on CDC’s web pages for each vaccine (U.S. COVID-19 Vaccine Product Information) and in the Vaccine Storage and Handling Toolkit, COVID-19 Vaccine Addendum.

COVID-19 vaccination providers are required to report information on vaccine supply, vaccine administration, and vaccine adverse events. Reporting this information is critical to help stop the COVID-19 pandemic.

Vaccine supply

All COVID-19 vaccination providers must report COVID-19 vaccine inventory daily in the COVID Locating Health Provider Portal. In some jurisdictions, providers may report vaccine inventory to the jurisdiction’s IIS for the jurisdiction to upload into the portal. If you have questions about the inventory reporting process for your jurisdiction, please contact your jurisdiction’s immunization program. Learn more at Vaccines.gov.

Vaccine administration data

COVID-19 vaccination providers, after administering a dose of COVID-19 vaccine, must record all information marked by an asterisk below (if it is not already recorded in the vaccine recipient’s record) and report the following required vaccine administration data, or other data elements if revised by CDC, to the appropriate entity noted in the agreement:

1. Administered at location/facility name/ID
2. Administered at location type
3. Administration address (including company)*
4. Recipient name and ID*
5. Recipient date of birth*
6. Recipient sex*
7. Recipient race
8. Recipient ethnicity
9. Recipient address*
10. Administration date*
11. CVX (product)*
12. NDC (national drug code)
13. Dose number*
14. Lot number (Unit of Use [UoU] or Unit of Sale [UoS])*
15. MVX (manufacturer)*
16. Sending organization (name of the agency submitting the report)
17. Vaccine administering provider’s name and suffix*
18. Administering provider’s address, if different from the administration address*
19. Vaccine administration site (on the body)*
20. Vaccine expiration date*
21. Vaccine route of administration*
22. Vaccine series

Find more information about vaccine administration and reporting requirements.

Vaccine adverse events

Healthcare providers are required under Emergency Use Authorization (EUA) to report to the Vaccine Adverse Event Reporting System (VAERS) the following adverse events (AEs) after COVID-19 vaccination (and other adverse events if later revised by CDC):

• Vaccine administration errors, whether associated with an AE or not
• Cases of COVID-19 that result in hospitalization or death
• Serious AEs regardless of causality, defined by the U.S. Food and Drug Administration (FDA) as:
  • Death
  • Life-threatening AE
  • Inpatient hospitalization or prolongation of existing hospitalization
  • Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
  • Congenital anomaly/birth defect
  • An important medical event that, based on appropriate medical judgement, may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.
• Cases of multisystem inflammatory syndrome

Healthcare providers are encouraged to report to VAERS any additional clinically significant AEs following vaccination, even if they are not sure if vaccination caused the event. Also report any additional select AEs and/or any revised safety reporting requirements per FDA’s conditions of authorized use of vaccine(s) throughout the duration of any COVID-19 vaccine being authorized under an EUA.

Vaccination provider requirements can be found at COVID-19 Vaccination Provider Requirements and Support.

Yes. Healthcare providers are the most trusted source of health information for their patients. Even if you are not participating in the CDC COVID-19 Vaccination Program, you play an important role in helping to educate and encourage your patients and others to get vaccinated. A provider’s recommendation has been shown to be an important factor in vaccine acceptance. CDC has many resources to assist you with educating your patients, staff, families, and communities. Check your patients’ vaccination status at routine appointments and, if they are unvaccinated, provide guidance on where they can get vaccinated. For example, you can use Vaccines.gov to locate vaccination sites or consider partnering with a COVID-19 vaccination provider to whom you can refer patients.

Visit the Vaccine Adverse Event Reporting System (VAERS) for information about all reporting requirements or to submit a report.

COVID-19 vaccination providers are required to report vaccine administration errors to VAERS, even if the error is not associated with an adverse event. They are also required to report certain adverse events after COVID-19 vaccination (and other adverse events if later revised by CDC).

You are required to provide patients with a COVID-19 vaccination record card, included in the ancillary supply kits for COVID-19 vaccines, and an EUA Fact Sheet for Recipients and Caregivers for the vaccine product administered. Vaccination providers should also provide vaccine recipients with information about participating in v-safe, CDC’s smartphone-based after-vaccination health checker that uses text messaging and web surveys to provide personalized health check-ins.

As we learn more about COVID-19 vaccines and how to best implement the CDC COVID-19 Vaccination Program, CDC posts updates and amendments to the COVID-19 Provider Agreement on its website. COVID-19 vaccination providers are responsible for checking this web page regularly for any updates and are required to comply with these updates.

CDC has a variety of educational materials and resources for you and your patients. Visit Vaccine Recipient Education for information on communicating with patients about COVID-19 vaccines and educational materials for patients.