CDC COVID-19 Vaccination Program Provider Agreement

Please complete Sections A and B of this form as follows:

The Centers for Disease Control and Prevention (CDC) greatly appreciates your organization’s (Organization) participation in the CDC COVID-19 Vaccination Program. Your Organization’s chief medical officer (or equivalent) and chief executive officer (or chief fiduciary)—collectively, Responsible Officers—must complete and sign the CDC COVID-19 Vaccination Program Provider Requirements and Legal Agreement (Section A). CDC COVID-19 Vaccination Program Provider Profile Information (Section B) must be completed for each vaccination location covered under the Organization listed in Section A.

I understand this is an agreement between Organization and CDC. This program is a part of collaboration under the relevant state, local, or territorial immunization’s cooperative agreement with CDC. To receive one or more of the publicly funded COVID-19 vaccines (COVID-19 Vaccine), constituent products, and ancillary supplies at no cost, Organization agrees that it will adhere to the following requirements:

1. Organization must administer COVID-19 Vaccine in accordance with all requirements and recommendations of CDC and CDC’s Advisory Committee on Immunization Practices (ACIP). (I)

2. Within 24 hours of administering a dose of COVID-19 Vaccine and adjuvant (if applicable), Organization must record in the vaccine recipient’s record and report required information to the relevant state, local, or territorial public health authority. Details of required information (collectively, Vaccine-Administration Data) for reporting can be found on CDC’s website. (II)

Organization must submit Vaccine-Administration Data through either (1) the immunization information system (IIS) of the state and local or territorial jurisdiction or (2) another system designated by CDC according to CDC documentation and data requirements.

Organization must preserve the record for at least 3 years following vaccination, or longer if required by state, local, or territorial law. Such records must be made available to any federal, state, local, or territorial public health department to the extent authorized by law. 

3. Organization must not sell or seek reimbursement for COVID-19 Vaccine and any adjuvant, syringes, needles, or other constituent products and ancillary supplies that the federal government provides without cost to Organization.

4. Organization must administer COVID-19 Vaccine regardless of the vaccine recipient’s ability to pay COVID-19 Vaccine administration fees.

5. Before administering COVID-19 Vaccine, Organization must provide an approved Emergency Use Authorization (EUA) fact sheet or vaccine information statement (VIS), as required, to each vaccine recipient, the adult caregiver accompanying the recipient, or other legal representative.

6. Organization’s COVID-19 vaccination services must be conducted in compliance with CDC’s Guidance for Immunization Services During the COVID-19 Pandemic for safe delivery of vaccines. (III)

7. Organization must comply with CDC requirements for COVID-19 Vaccine management. Those requirements include the following:

a) Organization must store and handle COVID-19 Vaccine under proper conditions, including maintaining cold chain conditions and chain of custody at all times in accordance with the manufacturer’s package insert and CDC guidance in CDC’s Vaccine Storage and Handling Toolkit (IV), which will be updated to include specific information related to COVID-19 Vaccine;

b) Organization must monitor vaccine-storage-unit temperatures at all times using equipment and practices that comply with guidance located in CDC’s Vaccine Storage and Handling Toolkit (IV);

c) Organization must comply with each relevant jurisdiction’s immunization program guidance for dealing with temperature excursions;

d) Organization must monitor and comply with COVID-19 Vaccine expiration dates; and

e) Organization must preserve all records related to COVID-19 Vaccine management for a minimum of 3 years, or longer if required by state, local, or territorial law.

8. Organization must report the number of doses of COVID-19 Vaccine and adjuvants that were unused, spoiled, expired, or wasted as required by the relevant jurisdiction.

9. Organization must comply with all federal instructions and timelines for disposing COVID-19 vaccine and adjuvant, including unused doses. (V)

10. Organization must report moderate and severe adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS). (VI)

11. Organization must provide a completed COVID-19 vaccination record card to every COVID-19 Vaccine recipient, the adult caregiver accompanying the recipient, or other legal representative. Each COVID-19 Vaccine shipment will include COVID-19 vaccination record cards.

12. 

a) Organization must comply with all applicable requirements as set forth by the U.S. Food and Drug Administration, including but not limited to requirements in any EUA that covers COVID-19 Vaccine.

b) Organization must administer COVID-19 Vaccine in compliance with all applicable state and territorial vaccination laws.

This agreement expressly incorporates all recommendations, requirements, and other guidance that this agreement specifically identifies through footnoted weblinks. Organization must monitor such identified guidance for updates. Organization must comply with such updates.

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(I) https://www.cdc.gov/vaccines/hcp/acip-recs/index.html
(II) https://www.cdc.gov/vaccines/programs/iis/index.html
(III) https://www.cdc.gov/vaccines/pandemic-guidance/index.html
(IV) https://www.cdc.gov/vaccines/hcp/admin/storage-handling.html
(V) The disposal process for remaining unused COVID-19 Vaccine and adjuvant may be different from the process for other vaccines; unused vaccines must remain under storage and handling conditions noted in Item 7 until CDC provides disposal instructions; website URL will be made available.
(VI) https://vaers.hhs.gov/reportevent.html

By signing this form, I certify that all relevant officers, directors, employees, and agents of Organization involved in handling COVID-19 Vaccine understand and will comply with the agreement requirements listed above and that the information provided in sections A and B is true.

The above requirements are material conditions of payment for COVID-19 Vaccine-administration claims submitted by Organization to any federal healthcare benefit program, including but not limited to Medicare and Medicaid, or submitted to any HHS-sponsored COVID-19 relief program, including the Health Resources & Services Administration COVID-19 Uninsured Program. Reimbursement for administering COVID-19 Vaccine is not available under any federal healthcare program if Organization fails to comply with these requirements with respect to the administered COVID-19 Vaccine dose. Each time Organization submits a reimbursement claim for COVID-19 Vaccine administration to any federal healthcare program, Organization expressly certifies that it has complied with these requirements with respect to that administered dose.

Non-compliance with the terms of Agreement may result in suspension or termination from the CDC COVID-19 Vaccination Program and criminal and civil penalties under federal law, including but not limited to the False Claims Act, 31 U.S.C. § 3729 et seq., and other related federal laws, 18 U.S.C. §§ 1001, 1035, 1347, 1349.

By entering Agreement, Organization does not become a government contractor under the Federal Acquisition Regulation.

Coverage under the Public Readiness and Emergency Preparedness (PREP) Act extends to Organization if it complies with the PREP Act and the PREP Act Declaration of the Secretary of Health and Human Services. (VII)

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(VII) See Pub. L. No. 109-148, Public Health Service Act §§ 319F-3 and 319F-4, 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e; 85 Fed. Reg. 15,198, 15,202 (March 17, 2020).

For official use only:

*The jurisdiction's immunization program is required to create a unique COVID-19 ID for the organization named in Section A that includes the awardee jurisdiction abbreviation (e.g., an organization located in Georgia could be assigned "GA123456A"). This ID is needed for CDC to match Organizations (Section A) with one or more Locations (Section B). These unique identifiers are required even if there is only one location associated with an organization.

For official use only:

**The jurisdiction’s immunization program is required to create an additional unique Location ID for each location completing Section B. The number will include the awardee jurisdiction abbreviation. For example, if an organization (Section A) in Georgia (e.g., GA123456A), has three locations (main location plus two additional) completing section B, t hey could be numbered as GA123456B1, GA123456B2, and GA123456B3.

*https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-at-increased-risk.html

I attest that each unit listed will maintain the appropriate temperature range indicated above: (please sign and date)