Long Term Care Facilities Enrolling in CDC COVID-19 Vaccination Program 90 Day Initiative Using the Sub-Provider Agreement

The Centers for Disease Control and Prevention (CDC) greatly appreciates your organization’s participation in the CDC COVID-19 Vaccination Program. A major goal of this program is to improve vaccine uptake in long term care facilities (LTCF). LTCFs should reach out to their enrolled pharmacy provider or local health department to facilitate vaccination in their facilities. LTCFs that are not partnered with an enrolled pharmacy or local health department to conduct on-site vaccination clinics, and are unable to do so through the existing CDC COVID-19 Vaccination Program, may choose to participate in the program through a sub-provider agreement. This sub-provider Agreement is only for use by long term care facilities (LTCF) not already enrolled as full providers in the CDC COVID-19 Vaccination Program that wish to access single dose vial COVID-19 vaccine through enrolled pharmacy providers for direct administration by the LTCF to their residents and staff. These LTCFs should reach out to a select enrolled pharmacy provider to discuss intentions to participate in the COVID-19 Vaccination Program as a sub-provider prior to submitting a sub-provider Agreement. This Agreement is interim and valid through March 15, 2023, unless extended by CDC.

NOTE: Pfizer-BioNTech COVID-19 Vaccine for people 12 years of age and older in single-dose vials is the ONLY vaccine product/presentation available in this program.

To qualify for this program, the LTCF:

Must partner with a designated pharmacy enrolled as a COVID-19 Vaccine Provider
Cannot be a regular fully enrolled COVID-19 Vaccine Provider

General Planning

Review requirements outlined in the COVID-19 Vaccine Sub-Provider Agreement.
Be aware of any state-specific requirements, e.g., training or data reporting requirements.
Assign a staff member(s) to lead the program.
Identify a pharmacy provider.
- Your pharmacy provider must be currently enrolled as a COVID-19 Vaccine Provider.
- If your facility does not have a pharmacy provider, contact:
  - A local, currently enrolled pharmacy to see if they would be willing to participate or
  - The immunization program at your state/local health department for potential partners.
- Identify the point of contact for your pharmacy provider.
Complete and submit the online sub-provider agreement, and download a copy for your records.
Share the following information with your pharmacy provider:
- Contact information for the LTCF responsible official, and other LTCF leads.
Determine staff roles and training needs.
Create plans to educate all staff of the importance of COVID-19 vaccination for residents and staff.
Encourage consistent messages emphasizing the importance of vaccination from all staff to residents, family members and other visitors.

Any long term care facility that receives COVID-19 vaccine from a COVID-19 Vaccine Provider Pharmacy must be enrolled in CDC’s COVID-19 Vaccination Program 90 Day Initiative using the Sub-Provider Agreement for Long Term Care Facilities.
All staff who receive, handle, manage, prepare, or administer vaccine must be fully trained on storage, handling, preparation, and administration requirements for COVID-19 vaccine as applicable to the individual’s role.

Storage and Handling

Review the storage and handling guidance for Pfizer-BioNTech COVID-19 vaccine (gray cap, single-dose vial) for persons 12 years of age and older.
Determine where the vaccine will be stored. There are 2 options:
- Option 1: At the partnering pharmacy until transported to the LTCF for immediate administration.
  Create a process with your pharmacy partner for obtaining:
  Initial supply of vaccine and CDC COVID-19 vaccination record cards.
  Additional doses of vaccine and record cards as needed.
  Follow the manufacturer’s and CDC’s guidance on transporting the vaccine.
  Identify staff who will:
  Contact your pharmacy partner and order COVID-19 vaccine.
  Accept the vaccine delivery from the pharmacy, check for the correct number of doses, and monitor applicable beyond-use times.
  Pfizer-Bio-NTech COVID-19 vaccine (gray-capped single-dose vials) can be stored between 8°C to 25°C (46°F to 77°F) for up to 12 hours. If not administered within 12 hours, the vaccine must be discarded.
- Option 2. At the Long Term Care Facility.
  Follow the manufacturer’s and CDC’s guidance on storing the vaccine.
  Create a process with your pharmacy partner for obtaining:
  
  Initial supply of vaccine and CDC COVID-19 vaccination record cards.
  Additional doses of vaccine and record cards as needed.
  Assess for storage equipment needs.
  Pfizer-BioNTech COVID-19 vaccine (gray-capped single-dose vials) may be stored between 2°C and 8°C
  (36°F and 46°F) for up to 10 weeks. If not administered within 10 weeks, the vaccine must be discarded.
  Identify staff who will:
  Read and record storage unit temperatures each workday.
  Monitor inventory weekly.
  Order more vaccine, as needed.
Establish a process for training appropriate staff on vaccine storage and handling practices.
COVID-19 Vaccine Training Modules (cdc.gov)
Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov)
Pfizer-BioNTech COVID-19 Vaccine: Transporting Vaccine for Vaccination Clinics Held at Satellite, Temporary, or Off-Site Locations Procedure (cdc.gov)
Determine a process to identify, manage, and report vaccines exposed to out-of-range temperatures.
Determine 3-year record retention protocols for vaccine storage documentation including expired or wasted vaccine.

Vaccine storage unit must be able to maintain the appropriate temperatures.
A “dormitory-style” unit CANNOT be used – even for temporary storage. These units have a single exterior door and an evaporator plate/cooling coil, usually located in an icemaker/freezer compartment and are a significant risk for out-of-range storage temperatures.
Food or drink cannot be stored in the vaccine storage unit.
A digital data logger (DDL) must be used to monitor the storage unit temperature.
Storage unit temperatures must be read and recorded at least once each workday.
Store the vaccine at the appropriate temperatures and monitor beyond-use times/dates if applicable.
Vaccine must be transported following the manufacturer’s and CDC’s guidance
Document and report expired or wasted vaccine.
All temperature excursions must be documented, and appropriate actions taken.

Vaccine Administration

Review Pfizer-BioNTech COVID-19 Vaccine clinical materials including modules, videos, and job aids.
Establish a process for training appropriate staff on vaccine administration practices.
- Vaccine Administration: Intramuscular (IM) injections: Adults 19 years of age and older (cdc.gov)
Establish standing orders, if applicable.
Assess for needed injection supplies.
Establish a process to remind staff administering vaccine when a resident’s dose is due.
- COVID-19 Vaccine Interim COVID-19 Immunization Schedule for 6 Months of Age and Older (cdc.gov)
Develop emergency protocols and assess for any needed emergency supplies.
Determine a process to provide the appropriate FDA Recipient Vaccine Information Fact Sheet to vaccine recipients or designated guardian.
Use the prevaccination checklist and guidance to screen for contraindications and precautions.
Identify a designated area to prepare the vaccine.
Establish a process to monitor beyond-use times (12 hours) for vaccine stored between 8°C to 25°C (46°F to 77°F).
Document the vaccine in the recipient’s medical record and CDC COVID-19 vaccination record card.
Determine how vaccine adverse events and vaccine administration errors will be reported to the Vaccine Adverse Event Reporting System.

Vaccine must be prepared and administered following the manufacturer’s and CDC’s guidance.
COVID-19 vaccine must be administered regardless of an individual’s ability to pay and regardless of their insurance coverage status, and do not seek any reimbursement from the recipient or recipient’s family. May seek appropriate reimbursement from a program or insurer that covers COVID-19 vaccine administration fees for the vaccine recipient.
Distribute the current, corresponding Recipient/Caregiver FDA Vaccine Information Fact Sheet(s) (hard copy or electronically) prior to each COVID-19 vaccine dose administered.
Document administered doses on a CDC COVID-19 vaccination record card and in the recipient’s medical record within 24 hours of administration.
Vaccine administration errors must be reported to the Vaccine Adverse Event Reporting System (VAERS).

Frequently Asked Questions

Can a facility select, via the website, a pharmacy with which it does not already have an existing contractual relationship? If so, is the pharmacy obligated to follow the reporting requirement within the CDC Provider Agreement signed by pharmacies via the GPOs?

The Long-term Care Facility (LTCF) 90-day COVID-19 Vaccination Initiative is intended to create more channels, not alter existing channels, for vaccine administration to those most at risk from death or severe illness from COVID-19. The sub-provider agreement will allow flexibility for the distribution of COVID-19 vaccine doses to LTCFs that are (1) not currently directly enrolled as COVID-19 vaccination providers or (2) not currently working as a contractor under the auspices of an enrolled pharmacy provider where the contractor LTCF is already administering COVID-19 vaccines on behalf of the pharmacy.

The initiative is not intended to obviate existing reporting to Immunization Information Systems (IISs) by enrolled pharmacy providers either conducting on-site COVID-19 vaccination at a LTCF or using contractor staff (including LTCF staff as contractors of the pharmacy) to vaccinate on-site at a LTCF. Under those situations, the pharmacies retain the obligation to report to the applicable IIS COVID-19 vaccine administration data for doses administered by the pharmacy or on their behalf.

The initiative allows pharmacies that will not conduct on-site COVID-19 vaccination (through pharmacy or contractor staff) to have a role of only being responsible for transferring COVID-19 vaccine doses to an LTCF enrolled as a sub-provider. In that instance, the enrolled LTCF sub-provider will not be considered a contractor of the pharmacy. Additionally, the LTCF sub-provider will directly vaccinate its residents and staff and will also be responsible for fulfilling all of the terms of the sub-provider agreement upon receipt of doses from the pharmacy. The pharmacy will have no responsibilities for any actions beyond transferring COVID-19 vaccine doses to the sub-provider. Also, where the sub-provider is not currently registered with an IIS or is not required under state law to report vaccine administration data to an IIS, the sub-provider agreement allows such LTCF to not report to the IIS during the 90 days of the sub-provider initiative.

Does the sub-provider agreement allow the long-term care pharmacy to charge a delivery service fee for shipping the vaccine?

The provider agreement does not prohibit or restrict pharmacies from charging fees to LTCFs for the logistical costs of transporting vaccines to them, as long as nothing comes out of pocket (directly or indirectly) from the vaccine recipient. Pharmacies should check with their legal counsel to make sure that no such logistical fee arrangements conflict with Medicare or Medicaid requirements.

Does the reporting waiver mean that after 90 days LTCFs need to report all the vaccinations administered in the prior 90 days, or does it mean that any vaccines administered during the waiver period will never be reported?

LTCFs are not required under the sub-provider agreement to report administrations to the IIS during the 90-day period, unless they are otherwise required to do so under state law. While reporting of administrative data to IIS remains important and is encouraged, this temporary waiver may help remove barriers to vaccination, and thus assist in increasing vaccine access in these specific facilities. It is expected that following this 90-day initiative, reporting will likely revert back to initial provider requirements.

Will single-dose vials of the bivalent Moderna COVID-19 vaccine become available in time for use in this initiative?

At this time, there are no expectations of Moderna single dose vials being available during the 90-day duration of this initiative.

On March 15th, or once this agreement ends, is it expected that COVID-19 vaccines will be commercialized?

The 90-day long-term care facility vaccination initiative is a short-term action intended to increase administrations in a targeted population. The transition of COVID-19 medical countermeasures to the commercial marketplace is an independent process and this initiative has no bearing on that timeline.

Is waste reporting no longer a requirement once the doses are transferred to the LTCF? If so, whose responsibility is it to report wasted/expired doses once it leaves the pharmacy? What is the process?

Section 8 of the sub-provider agreement requires preservation of all records related to COVID-19 vaccine management for a minimum of 3 years, including documentation regarding expired or wasted vaccine.

Is inventory reporting by pharmacies still required? Once doses are transferred to LTCFs participating in this initiative, should pharmacies reduce the counts from inventory regardless of whether doses will be administered, wasted, or kept in storage for future use onsite at the LTCF?

Pharmacies sending COVID-19 vaccine doses to sub-provider LTCFs must adjust their inventory supply levels to account for those transfers. The sub-provider LTCF becomes accountable for the doses at that point.