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Pandemic Provider Agreement

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CDC COVID-19 Vaccination Program Provider Agreement

Please complete Section 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). In addition, the 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.

Section A. COVID-19 Legal Agreement

Section A. COVID-19 Vaccination Program Provider Requirements and Legal Agreement

Organization Identification

Organization legal name: *

Number of affiliated vaccination locations covered by this agreement: *

Organization Telephone: *

Please use this format for Telephone: 555-555-5555

Email: *

(must be monitored and will serve as dedicated contact method for the COVID-19 Vaccination Program)

Street Address 1: *

Street Address 2:

City: *

County: *

State: *

Zip: *

Responsible Officers

For the purposes of this agreement, in addition to Organization, Responsible Officers named below will also be accountable for compliance with the conditions specified in this agreement. The individuals listed below must provide their signatures after reviewing the agreement requirements.

Chief Medical Officer (or Equivalent) Information

Last Name: *

First Name: *

Middle Initial:

Title: *

Licensure State: *

Licensure Number: *

Telephone: *

Email: *

Street Address 1: *

Street Address 2:

City: *

County: *

State: *

Zip: *

Chief Executive Officer (or Chief Fiduciary) Information

Last Name: *

First Name: *

Middle Initial:

Telephone: *

Email: *

Street Address 1: *

Street Address 2:

City: *

County:

State: *

Zip: *

Agreement Requirements

I understand this is an agreement between Organization and CDC. This program is part of a collaboration under the relevant state, local, or territorial immunization program 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:

We Agree to Condition #1 *

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).(1)

We Agree to Condition #2 *

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.(2)

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.(2)

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

We Agree to Condition #3 *

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.

We Agree to Condition #4 *

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

We Agree to Condition #5 *

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.

We Agree to Condition #6 *

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.(3)

We Agree to Condition #7 *

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,
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 in CDC s
Vaccine Storage and Handling Toolkit(4);

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.

We Agree to Condition #8 *

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.

We Agree to Condition #9 *

9. Organization must comply with all federal instructions and timelines for disposing of COVID-19 vaccine and adjuvant, including unused doses. (5)

We Agree to Condition #10 *

10. Organization must report any adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS) (1-800-822-7967 or https://vaers.hhs.gov/contact.html

We Agree to Condition #11 *

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

We Agree to Condition #12 *

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. Organization must monitor such identified guidance for updates. Organization must comply with such updates.

1. www.cdc.gov/vaccines/hcp/acip-recs/index.html
2. www.cdc.gov/vaccines/programs/iis/index.html
3. www.cdc.gov/vaccines/pandemic-guidance/index.html
4. www.cdc.gov/vaccines/hcp/admin/storage-handling.html

5. 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.
6. See Pub. L. No. 109-148, Public Health Service Act � 319F-3, 42 U.S.C. � 247d-6d and 42 U.S.C. � 247d-6e; 85 Fed. Reg. 15,198, 15,202 (March 17, 2020)

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, Medicaid, and the Health Resources and Services Administration COVID-19 Uninsured Program. Reimbursement for administering COVID-19 vaccine is not available under any federal healthcare benefit 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 benefit 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.6

Organization Medical Dir.(or Equivalent)

Last Name: *

First Name: *

Middle Initial:

Signature:

Date: *

Chief Executive Officer (Fiduciary Role)

Last Name: *

First Name: *

Middle Initial:

Signature:

Date: *

Upon saving and closing this form, you will have completed Section A of the CDC COVID-19 Vaccine Provider Agreement. An email will be sent to the organizational email address provided with a copy of the completed form. Please print and sign under Chief Medical Officer and Chief Executive Officer and return by email to COVID-19.vaccine@dc.gov.

To complete Section B and add individual vaccination locations (otherwise known as facilities), please return to the email and near the bottom, CLICK "Add Location." It will resume your submission and you will be in Section B. You will need to add each individual vaccination location or facility separately by returning to the email.

For Official Use Only

For Official use Only:

IIS ID, If Applicable:

Enrollment Status:

Date App. Received:

Date App. Disposition:

Locations

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