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To: Maine Immunization Program Providers
From: Maine Immunization Program
Subject: COVID-19 Vaccine Transition to Commercialization
Date: July 18, 2023
COVID-19 Vaccine Transition to Commercialization
In preparation for commercialization and with a new presentation of COVID-19 vaccine becoming available this Fall, it is important for providers to stay informed. Here are some key points:
Commercialization
A monovalent XBB.1.5 composition vaccine will be available directly from the manufacturers as part of the commercial market, rather than through the United States Government (USG).
Timeline for Commercialization (All subject to change)
The transition of vaccines to more traditional pathways for procurement, distribution, and payment is expected to occur in early fall. The exact dates for COVID-19 vaccines are being determined and more information will be shared when available.
Guidance on Inventory and Disposal
Providers should maintain their inventories of EUA and/or BLA vaccines until the vaccine exceeds its shelf life, OR the FDA announces a change to EUAs and/or BLA vaccine, whichever occurs first.
Any vial of vaccine that has exceeded the shelf-life indicated by the manufacturer should be disposed of in your facility’s medical waste. Providers must also report any wastage, including doses disposed of due to expiration to the Vaccine Tracking System (VTrckS).
Ancillary Kits
Ancillary kits will continue to be provided for vaccine orders placed following the August 2, 2023, cutoff date. Providers should maintain inventory of ancillary kits to continue administration to anyone who is eligible and interested in receiving an authorized vaccine.
Providers may opt out of receiving ancillary kits in Immpact. As a reminder, the expiration date printed on the exterior box of the ancillary kit does not apply to all of the items contained in the kit.
Please, do not discard the entire kit based on the date printed on the exterior label. The date on the exterior box of the ancillary kit reflects the expiry date for the surgical masks and the face shields. The expiration date for other supplies (needles, syringes, alcohol prep pads, etc.) are printed on the individual packaging on these products.
Please check the expiration dates of each individually packaged product in the ancillary kit to determine whether it remains good-dated and may be used. Never use expired equipment. Any expired products should be disposed of using normal means.
CDC Programs for Uninsured Individuals
Efforts are underway to provide support for the uninsured and underinsured populations. CDC will provide access to COVID-19 vaccines for uninsured individuals once COVID-19 vaccines become commercially available.
The Vaccines for Children Program will provide access for COVID-19 to children up through age 18 as part of routine vaccination.
Uninsured adults will be able to receive COVID-19 vaccines through the temporary Bridge Access Program. This program will consist of two components: the first component utilizes existing public health infrastructure including state immunization programs, local health departments, and HRSA-supported health centers to provide COVID-19 vaccines to uninsured adults. The second component will be implemented through contracts with pharmacy chains that will enable them to continue offering free COVID-19 vaccinations to the uninsured through their network or retail locations as has been done during the COVID-19 public health emergency.
More information about the Bridge Access Program for COVID-19 Vaccines and Treatments can be found online at: Fact Sheet: HHS Announces ‘Bridge Access Program For COVID-19 Vaccines and Treatments’ to Maintain Access to COVID-19 Care for the Uninsured.
COVID-19 Vaccination Program Provider Agreement
As a reminder, at this time providers are still required to adhere to their current CDC COVID-19 Vaccination Program Provider Agreement, which requires that all organizations and providers participating in the CDC COVID-19 Vaccination Program:
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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
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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
- may not seek any reimbursement, including through balance billing, from the vaccine recipient
Please note that once COVID-19 vaccines have transitioned to the commercial market, the Maine Immunization Program will require that providers wishing to administer COVID-19 vaccines to VFC eligible children and uninsured/underinsured adults, must be fully enrolled in our state vaccination program.
For further information on reimbursement requirements, as well as general information and provider support for the COVID-19 Vaccination Program, please see the CDC COVID-19 Vaccination Program Provider Requirements and Support webpage. For a list of provider frequently asked questions about the COVID-19 Vaccination Program, please see the FAQs About Implementing COVID-19 Vaccination Program in Provider Practices.
Thank you for all you do to keep Mainers free from vaccine preventable disease. We will continue to keep you updated as we receive further guidance.
Should you have any questions, please contact the Maine Immunization Program at (207) 287-3746 or email: ImmunizeME.DHHS@maine.gov.
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