CDC COVID-19 Vaccination Program Provider Requirements and Support

www.cdc.gov/vaccines/hcp/acip-recs/index.html

CDC Requirements

Prioritization

Providers must administer COVID-19 vaccine in accordance with prioritization groups determined by appropriate public health authorities (i.e., HHS/CDC/ACIP, state/territorial health department in coordination with the state/territorial governor, Indian Health Service, Tribal Health Programs, Urban Indian Organizations, the Freely Associated States).

Provision of Information to Vaccine Recipients (Updated 2/9/22 to reference Moderna’s COVID-19 vaccine BLA approval)

Before administering COVID-19 Vaccine, providers must provide an approved FDA Emergency Use Authorization (EUA) Fact Sheet, FDA Vaccine Information Fact Sheet, or CDC Vaccine Information Statement (VIS), as applicable, to each vaccine recipient, the adult caregiver accompanying the recipient, or other legal representative.

In lieu of CDC developing a separate COVID-19 Vaccine Information Statement (VIS) at this time for the licensed Pfizer vaccine, FDA has issued a combination COVID-19 Vaccine Information Fact Sheet for Recipients and Caregivers to address both the FDA authorized (EUA) Pfizer-BioNTech COVID-19 Vaccine and the FDA Biologics License Application (BLA) approved (licensed) Pfizer-BioNTech COMIRNATY COVID-19 Vaccine. The vaccines have identical formulations. When administering the Pfizer-BioNTech COVID-19 vaccine under either the EUA or under BLA approval, providers must give each vaccine recipient, adult caregiver accompanying the recipient, or other legal representative, a copy of the age-appropriate Pfizer-BioNTech COVID-19 Vaccine Information Fact Sheet.

Similarly, in lieu of a separate COVID-19 VIS for the licensed Moderna vaccine, FDA has issued a combination Moderna COVID-19 Vaccine Fact Sheet for Recipients and Caregivers to address both the FDA authorized (EUA) Moderna COVID-19 Vaccine and the FDA BLA approved (licensed) Moderna SPIKEVAX COVID-19 Vaccine.  The vaccines have identical formulations.  When administering the Moderna COVID-19 vaccine under either the EUA or under BLA approval, providers must give each vaccine recipient, adult caregiver accompanying the recipient, or other legal representative, a copy of the combined Moderna COVID-19 Vaccine Information Fact Sheet.

[Additions to CDC COVID-19 Vaccination Program Provider Agreements, Paragraph 1.]

Diversion of COVID-19 Vaccines Prohibited (updated 06/11/2021)

At this time, all COVID-19 vaccine in the United States has been purchased by the United States Government for administration exclusively through the CDC COVID-19 Vaccination Program. The vaccine and all related ancillary supplies, including the COVID-19 Vaccination Cards, remains U.S. government property until vaccine is administered to the recipient. Inherent in the reference to COVID-19 vaccine remaining property of the United States Government, all USG-furnished ancillary materials, including COVID-19 Vaccination Record Cards, have remained property of the United States Government for exclusive use in the CDC COVID-19 Vaccination Program since the program’s inception. This includes COVID-19 Vaccination Record Cards that have been printed by agents on behalf of CDC, including the jurisdictions.

USG-provided COVID-19 Vaccination Record Cards remain property of the United States Government until provided to the vaccine recipient following vaccination through the CDC COVID-19 Vaccination Program. The COVID-19 Vaccination Record Cards may not be reproduced by anyone other than authorized jurisdictions or without written permission of CDC. Any use or unauthorized reproduction of the COVID-19 Vaccination Cards outside of the CDC COVID-19 Vaccination Program, or production or use of similar facsimiles of such cards, is prohibited. Any such unauthorized production or use constitutes fraud and is subject to criminal or civil prosecution for violation of 18 U.S.C. § 1001, 42 U.S.C. § 1320b-10, or other relevant federal statutes.

COVID-19 vaccination providers are prohibited from selling USG-purchased COVID-19 vaccine (and ancillary materials purchased by the USG for use in the Vaccination Program), soliciting or receiving any inducement, whether direct or indirect, for vaccinating (or providing COVID-19 vaccine to be used for vaccinating) any individual who is not currently eligible to receive COVID-19 vaccine as a member of a group currently authorized under prioritization specified by HHS/CDC/ACIP, the state/territory’s governor or other relevant public health authority, or otherwise diverting COVID-19 vaccine from the CDC COVID-19 Vaccination Program. Such use constitutes fraud and is a violation of the terms of the provider agreement. It shall be cause for immediate termination from the CDC COVID-19 Vaccination Program and criminal or civil prosecution for violation of 18 U.S.C. § 1001 or other relevant federal statutes.

Note that transfer of COVID-19 Vaccine through the CDC authorized redistribution process from one enrolled provider to another enrolled provider for authorized vaccination is not considered to be diversion of COVID-19 vaccine.

Further, a good faith judgment call by an enrolled provider to administer excess doses to individuals outside of authorized prioritization groups, without malintent and without direct/indirect receipt of inducement, will not be considered a prohibited diversion if such vaccine doses have been prepared for scheduled administration and would otherwise be wasted due to expiration.

Use of Vaccine Recipient Data for Commercial Marketing Purposes Prohibited  (5/18/2021)

Notwithstanding uses or disclosures otherwise allowed by law, providers are prohibited from using or disclosing data collected from vaccine recipients for and through the CDC COVID-19 Vaccination Program for commercial marketing purposes or for any other purpose not allowed under this updated provision of the COVID-19 Vaccination Provider Agreement.  Such data include COVID-19 vaccination registration information and vaccine administration data.  These data are collected solely for the purposes of the CDC COVID-19 Vaccination Program and must be maintained in a manner that protects the integrity of the CDC COVID-19 Vaccination Program by only being used or disclosed for the purposes of the COVID-19 Vaccination Program and other limited purposes that promote public health, advance positive patient outcomes, and promote health equity.

This prohibition is not intended to limit communications by health care providers to vaccine recipients with whom the provider has an existing relationship prior to contact about COVID-19 vaccination.

The following are not included in the above prohibition:

• Communications regarding receipt of a second dose, or potential booster dose(s), of COVID-19 vaccine
• Communications to vaccine recipient for public health purposes
• Communications to vaccine recipients involving pharmacy or clinical services of the provider, personalized to the vaccine recipient’s medical needs, even if those services are not directly related to COVID-19 vaccination
• Availability of other vaccines (e.g., shingles, pneumococcal conjugate, seasonal influenza, routine childhood vaccines)
• Clinical emails
• Disease screening services
• Communications about the availability of programs to manage particular health conditions (e.g., asthma, diabetes, heart disease)

In addition, de-identified, aggregate datasets can be used by providers and shared with other partners for public health, population health, and health equity purposes.

Communications with COVID-19 vaccine recipients involving the store component of any pharmacy or other provider participating in the CDC COVID-19 Vaccination Program are considered prohibited commercial marketing.  For example, text, e-mail, mail, or other communications to COVID-19 vaccine recipients about products on sale in the store are prohibited as commercial marketing.

COVID-19 vaccination registration information and vaccine administration data collected in the course of participation in the CDC COVID-19 Vaccination Program cannot be sold, for direct or indirect remuneration, even with permission of the vaccine recipient.

Reporting Suspected Fraud or Abuse

Individuals becoming aware of any suspected fraud or abuse or violations of provider agreement requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services at 1-800-HHS-TIPS or TIPS.HHS.GOV.

COVID-19 Vaccine Administration Fees (updated 4/8/2022)

All organizations and providers participating in the CDC COVID-19 Vaccination Program:

• must administer COVID-19 Vaccine at no out-of-pocket cost to the recipient
• may not deny anyone vaccination based on the vaccine recipient’s coverage status or network status
• may not charge an office visit or other fee if COVID-19 vaccination is the sole medical service provided
• may not require additional medical services to receive COVID-19 vaccination
• may seek appropriate reimbursement from a program or plan that covers COVID-19 Vaccine administration fees for the vaccine recipient, such as:
  • vaccine recipient’s private insurance company
  • Medicare or Medicaid reimbursement
  • HRSA COVID-19 Coverage Assistance Fund for underinsured vaccine recipients (unavailable as of 11:59 ET on April 5, 2022, due to lack of supplemental funding)
  • HRSA COVID-19 Uninsured Program for non-insured vaccine recipients (unavailable as of 11:59 ET on April 5, 2022, due to lack of supplemental funding)
• may not seek any reimbursement, including through balance billing, from the vaccine recipient

For additional information on filing claims for reimbursement of COVID-19 vaccine administration fees, go to:

• CMS Guidance – https://www.cms.gov/covidvax-provider

CDC Statement on Exhaustion of Funding for the Uninsured Program and Coverage Assistance Fund

Due to the lack of supplemental funding from Congress, HRSA stopped accepting claims for reimbursement of costs associated with administering COVID-19 vaccines to uninsured and underinsured individuals as of 11:59 PM ET on April 5, 2022. CDC strongly encourages providers to stay in the CDC COVID-19 Vaccination Program and CDC expects participating providers will continue to administer these lifesaving vaccines at no cost to patients to ensure equitable access for all individuals. Where CDC becomes aware of a provider engaging in any of the following, CDC will consider taking any and all appropriate measures, including the possibility of rescinding the CDC provider agreement:

• Administering COVID-19 Vaccine at any out-of-pocket cost to the recipient
• Denying anyone vaccination, or differentially reducing appointment access, based on the vaccine recipient’s coverage status or network status
• Charging an office visit or other fee if COVID-19 vaccination is the sole medical service provided
• Requiring additional medical services to receive COVID-19 vaccination
• Seeking any reimbursement, including through balance billing, from the vaccine recipient

ACIP Recommendations (9/7/2021)

The Advisory Committee on Immunization Practices (ACIP) comprises 15 medical and public health experts who develop evidence-based recommendations for use of vaccines in the United States. The recommendations stand as public health guidance for the safe use of vaccines and related biological products. COVID-19 vaccination providers are required to implement all recommendations of the ACIP, adopted by the CDC Director, relevant to COVID-19 vaccination including:

• Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021
• Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021
• The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12–15 Years — United States, May 2021
• Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients — United States, April 2021
• Interim Recommendation for Use of Janssen COVID-19 Vaccine — United States, February 2021
• Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine, United States 2020
• Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine, United States, December 2020
• Interim Recommendation for Use of Moderna COVID-19 Vaccine, United States, December 2020
• Updated Interim Recommendation for Allocation of COVID-19 Vaccine, United States, December 2020

Find more information about vaccine administration and reporting requirements.

For those provider agreements not specifying vaccine administration data to be recorded or reported, the following applies:

After administering a dose of COVID-19 vaccine, record to the extent not already recorded in the vaccine recipient’s record all information marked below by an asterisk 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 than the administration address*
19. Vaccine administration site (on the body)*
20. Vaccine expiration date*
21. Vaccine route of administration*
22. Vaccine series

www.cdc.gov/vaccines/pandemic-guidance/index.html

The COVID-19 pandemic has caused healthcare providers to change how they operate to continue to provide essential services to patients. CDC has issued interim guidance for healthcare personnel in a variety of clinical and alternative settings for the safe administration of vaccines during the COVID-19 pandemic. COVID-19 vaccination providers are required to implement this guidance on safe vaccination practices, including COVID-19 safety measures (e.g., social distancing, mask wearing, hand hygiene), when providing COVID-19 vaccine.

http://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html

Vaccines must be stored and handled properly from the time they are manufactured until they are administered to maintain the cold chain, thus protecting the potency and effectiveness of the vaccine and ensuring vaccine recipients are fully and safely protected from vaccine-preventable diseases.

As part of the COVID-19 Vaccination Provider Agreement, providers are required to:

• Store and handle COVID-19 vaccines under proper conditions, including maintaining cold chain conditions and chain of custody at all times in accordance with an EUA or vaccine package insert, manufacturer guidance, and CDC guidance in the Vaccine Storage and Handling Toolkit.
• Monitor storage unit temperatures at all times, using equipment and practices that comply with guidance in the toolkit.
• Comply with immunization program guidance for handling temperature excursions.
• Monitor and comply with COVID-19 vaccine expiration dates.
• Preserve all records related to COVID-19 vaccine management for a minimum of three years, or longer as required by the agreement or law of the jurisdiction.
• Comply with CDC instructions and timelines for disposing of COVID-19 vaccine and diluent, including used doses.

Find detailed information regarding COVID-19 Vaccine storage and handling requirements at CDC Vaccine Storage and Handling Toolkit.

(https://vaers.hhs.gov/reportevent.html)

The Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in vaccines used in the United States. VAERS accepts and analyzes reports of adverse events (AEs) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.

The reporting requirements for COVID-19 vaccines are the same for those authorized under emergency use (EUA) or approved under a Biologics License Application (BLA). Healthcare providers who administer COVID-19 vaccines are required to report the following to VAERS:

• Vaccine administration errors, whether or not associated with an adverse event (AE)
  • If the incorrect mRNA COVID-19 vaccine product was inadvertently administered for a second dose in a 2-dose series, VAERS reporting is required.
  • If a different product from the primary series is inadvertently administered for the additional or booster (third dose), VAERS reporting is required.
  • VAERS reporting is not required for the following situations:
    • If a mixed series is given intentionally (e.g., due to hypersensitivity to a vaccine ingredient)
    • Mixing and matching of booster doses intentionally (as of October 21, 2021, mixing and matching of booster doses is allowed)
• Serious AEs regardless of causality. Serious AEs per FDA are defined as:
  • Death
  • A life-threatening AE
  • Inpatient hospitalization or prolongation of existing hospitalization
  • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
  • A 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 myocarditis after a Pfizer-BioNTech, Moderna, Novavax, or Janssen COVID-19 vaccine
• Cases of pericarditis after a Pfizer-BioNTech, Moderna, Novavax, or Janssen COVID-19 vaccine
• Cases of Multisystem Inflammatory Syndrome in children and adults
• Cases of COVID-19 that result in hospitalization or death

Healthcare providers are encouraged to report to VAERS any additional clinically significant AEs following vaccination, even if unsure whether 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’s Emergency Use Authorization (EUA)  or as outlined in the Fact Sheet for Healthcare Providers for any approved COVID-19 Vaccine.

COVID-19 vaccination providers perform vital functions within the CDC COVID-19 Vaccination Program, including properly storing, handling, and managing vaccine supply, as well as correctly administering vaccine to intended recipients. Thus, it is essential for providers to have a clear understanding of COVID-19 Vaccination Program requirements. Training, site visits, and other oversight measures are important for maintaining or improving providers’ adherence to these requirements. Site visits are a key opportunity for quality assurance monitoring and training (as necessary) enrolled providers. The goals of site visits are to:

• Assess COVID-19 vaccination provider adherence to program requirements and recommendations.
• Identify and address areas where providers are doing well and areas needing additional follow-up.
• Identify and address educational needs of COVID-19 vaccination providers to help them meet program requirements.
• Ensure that vaccine recipients are receiving properly managed and viable vaccine.

CDC and/or state/local public health staff are required to conduct certain provider oversight activities in each jurisdiction. COVID-19 vaccination providers and depot locations that store or redistribute COVID-19 vaccine must accommodate these staff and participate in COVID-19 quality assurance site visits and other educational opportunities associated with COVID-19 vaccination program requirements.