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., 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). [Update to CDC COVID-19 Vaccination Provider Agreement, Paragraph 1.]

Diversion of COVID-19 Vaccines Prohibited

COVID-19 vaccine providers are prohibited from selling USG-purchased COVID-19 vaccine, 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 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.

Individuals becoming aware of any potential violations of these 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.

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.

COVID-19 Vaccine Administration Fees

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

• must administer COVID-19 Vaccine regardless of the vaccine recipient’s ability to pay COVID-19 Vaccine administration fees or coverage status
• may seek appropriate reimbursement from a program or plan that covers COVID-19 Vaccine administration fees for the vaccine recipient
• 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:

• HRSA COVID-19 Uninsured Program – https://www.hrsa.gov/CovidUninsuredClaimexternal icon
• CMS Guidance – https://www.cms.gov/covidvax-providerexternal icon

ACIP Recommendations

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:

• 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 2020pdf icon
• 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 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.htmlexternal icon)

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.

Healthcare professionals are encouraged to report any clinically significant event following vaccination in VAERS, even if they are not sure if vaccination caused the event.

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

• Vaccine administration errors, whether or not associated with an adverse event (AE)
• Serious AEs regardless of causality. Serious AEs per FDA are defined as:
  1. Death;
  2. A life-threatening AE;
  3. Inpatient hospitalization or prolongation of existing hospitalization;
  4. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
  5. A congenital anomaly/birth defect;
  6. 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
• 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 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.