COVID-19: General Guidance for Vaccinators

General billing guidelines and requirements

The COVID-19 vaccine is provided to Wisconsin by the Federal Government and therefore must be administered at no cost to recipients. By signing the CDC COVID-19 Vaccination Program Provider Agreement to receive and dispense vaccines, providers are committing to being accountable for the conditions specified in the agreement.

In addition to the terms specified in the Provider Agreement, all organizations and providers participating in the CDC COVID-19 Vaccination Program are expected to adhere to the following CDC guidelines. COVID-19 vaccine providers:

• 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
• May not seek any reimbursement, including through balance billing, from the vaccine recipient
• 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

DHS is collaborating with our federal and state partners to closely monitor provider program compliance and billing practices. This includes investigating all instances of inappropriate billing and fraud reported by Wisconsinites, conducting analyses of COVID-19 vaccine administration data, and initiating CDC-required on-site visits.

Getting paid for COVID-19 vaccine administration

Each COVID-19 vaccine product and dose has its own Current Procedural Terminology (CPT®) code. Use these codes when requesting reimbursement from patients' private insurance or Medicare.

See the American Academy of Pediatrics’ COVID-19 Vaccine Administration: Getting Paid webpage for a list of all COVID-19 vaccine billing codes and more information.

Medicare COVID-19 vaccination for residents of small long-term care facilities

See information on Medicare payment for COVID-19 vaccine administration – including a list of billing codes, payment allowances and effective dates.

Report inappropriate billing practices and denied access to COVID-19 vaccine

Individuals aware of any potential violations of these requirements are encouraged to report them to the Wisconsin Department of Health Services (DHS).

• The public can file a complaint by calling 844-684-1064 (toll-free). The public can also report fraud, waste, and abuse of all other public funds to DHS through the fraud hotline at 877-865-3432 or through the fraud reporting website.
• Vaccinators can email DHSCovidVaccinator@dhs.wisconsin.gov to file a complaint.

Vaccination sites must maintain their Vaccines.gov profile. DHS strongly recommends that vaccinators ensure their profiles are publicly viewable on Vaccines.gov so that the public can use this resource to find COVID-19 vaccines.

Vaccinators need to provide public-facing information. Effective August 2, 2023, vaccinators must report inventory data from Wisconsin Immunization Registry (WIR) to Vaccines.gov as well as provide vaccine type and in-stock inventory data. DHS will continue to report site address information on behalf of vaccinators. It is very important for all vaccinators to keep their inventory up to date in WIR so the public has current information when choosing a vaccinator. Please note, Vaccines.gov only displays whether the vaccine is in-stock, it does not display inventory numbers.

Ensuring your profile is viewable

After enrolling as a COVID-19 vaccinator, the organization email account listed under Part A of your Provider Agreement should have received an email from vaccinefinder@auth.castlighthealth.com inviting you to create a COVID Locating Health Provider Portal Account on Vaccines.gov. This invitation expired after seven days.

To request an email invitation be resent to your organization, please email cars_helpdesk@cdc.gov from your organization email account listed under Part A of your Provider Agreement or by calling 1-833-748-1979.

If your organization email needs to be changed, you must fully complete and resubmit a Form A by logging into the COVID-19 Vaccinator Enrollment Tool.

Once your organization is registered with Vaccines.gov, you can set up the reporting structure for your organization. There are two options:

1. Under the organizational-level maintenance setup, the Part A contact (Organization contact) would be required to manage the details for the public profiles of all locations and only the Part A contact.
2. If the organization wishes to delegate the control of profile information to each location, they should set site-level maintenance. If the organization contact designates site-level reporting, this triggers registration emails to be sent to the site-level vaccine coordinators listed in section B of the Provider Agreement (primary and backup contacts). After registration is completed, the coordinators for each location would be able to log in independently and manage details for that specific location.

The CDC and Vaccines.gov provides resources for vaccinators. For password resets or general account/login-related questions, contact the CDC’s Vaccines.gov team at CARS_HelpDesk@cdc.gov.

Your location will be findable on Vaccines.gov if your location has vaccines in stock and you have set the location to be publicly viewable.

Note: only the first 50 results are shown so larger cities may not show all possible locations that match.

Support

The CDC and Vaccines.gov offer several resources for vaccinators. Reviewing the Vaccines.gov COVID-19 Vaccine Provider Process Overview webpage is recommended.

Please email DHSCovidVaccinator@wi.gov with the subject Vaccines.gov. A DHS representative will respond within one to three business days. If your location is no longer administering COVID-19 vaccines, please contact DHSCovidVaccinator@wi.gov to request inactivation.

For all other support including password resets, or general account/login-related questions, please contact the Vaccines.gov help desk at 833-748-1979 or email at CARS_HelpDesk@cdc.gov.

Call 608-266-9691 or email dhswirhelp@dhs.wisconsin.gov for additional assistance from the WIR Help Desk.

Reminder/recall notices in WIR

Reminder/recall report functions assist providers with outreach to their patients. Providers can send reminder notices to clients who have an immunization due soon to remind them to call and schedule an appointment. Recall notices are used for those clients who are overdue for a vaccine.

You can review this information in a video about the WIR reminder recall/report feature.

Vaccinators should consider connecting with their local and tribal health department about how to reach key community-based organizations in their area or reach out directly to organizations.

For more information and guidance for community-based and at-home vaccination visit: COVID-19: Vaccine Partner and Vaccinator Resources.

DHS recommends that everyone 6 months and older stay up to date with COVID-19 vaccines.

Wisconsin Immunization Registry verification

Vaccinators are encouraged to check the Wisconsin Immunization Registry (WIR) and/or a patient’s CDC vaccination card before administering a vaccine to verify that individuals are receiving the correct vaccine based on the specific vaccination schedule for their age group and/or medical history.

Vaccine cards are not required to get a COVID-19 vaccine dose. DHS urges vaccinators to administer a COVID-19 vaccine even if a patient does not have a COVID-19 vaccine card with them. DHS cannot issue COVID-19 vaccination cards.

For more information on vaccination record cards, visit: Your CDC COVID-19 Vaccination Record and Vaccination Card.

Resources

• CDC Interim Clinical Considerations
• Emergency Use Authorization (EUA) fact sheets
  • Pfizer-BioNTech COVID-19 vaccine EUA fact sheets
  • Moderna COVID-19 Vaccine EUA fact sheets
  • Novavax COVID-19 Vaccine EUA fact sheets

Observation period

Individuals receiving any vaccine, including COVID-19, need to be monitored for allergic reactions for 15-30 minutes after vaccination. Non-reactions to previous vaccinations are not a guarantee that a reaction will not occur. When administering doses, please make sure people wait before they leave your site.

COVID-19, influenza, and other vaccines may be administered without regard to timing. This includes simultaneous administration of COVID-19 vaccines and other vaccines on the same day, as well as co-administration within 14 days.

Giving all vaccines for which an individual is eligible at the same visit is considered a best practice as it increases the probability that individual will be up to date on recommended vaccines. It also is an important part of immunization practice, especially if a health care provider is uncertain that a patient will return for additional doses of vaccine.

Please reference CDC's clinical considerations for more details. CDC's short, recorded webinar on Administering More Than One Vaccine on the Same Day reviews the clinical considerations, best practices and clinical resources for simultaneous administration.

You can also print out Immunize.org's job aid, How to Administer Multiple Intramuscular Vaccines to Adults During One Visit.

Vaccinators need to ensure that emergency equipment is available regardless of the vaccine being administered. This includes epinephrine auto-injectors or epinephrine. If an ampule of epinephrine and needle/syringe is to be used, it is important that the provider be proficient in drawing up and administering the proper dosage.

ACIP General Best Practice Guidelines read, “Epinephrine and equipment for managing an airway should be available for immediate use.”

According to the CDC, state laws establish vaccination requirements for school-aged children. In Wisconsin, the age of majority is 18 years of age, unless emancipated. Therefore, all unemancipated individuals under 18 years of age require parent or guardian consent to receive the COVID-19 vaccine.

In Wisconsin, vaccinators can accept written or verbal (such as via telephone) consent to administer the COVID-19 vaccine from a minor’s legal parent or guardian who cannot be present at the time of vaccination. Vaccinators are not required to accept written or verbal consent but are permitted to accept these forms of consent should they choose to do so. DHS does not have a sample written consent form for vaccinators to use. Vaccinators are encouraged to work with their own legal counsel regarding methods of consent for vaccinating minors in their clinic.

Vaccine providers are responsible for adhering to all requirements outlined in the CDC COVID-19 Vaccination Program Provider Agreement. This applies to COVID-19 vaccines either authorized or approved by the FDA. Accordingly, use of these products outside of those that have been approved and authorized by FDA (off-label use) is not recommended.

People who are pregnant or recently pregnant should take steps to protect themselves from getting sick with COVID-19. COVID-19 vaccination is recommended for everyone aged 6 months and older, including people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future. If you are pregnant and have questions about getting a vaccination, find more information by visiting Pregnant and Recently Pregnant People.

Increased cases of myocarditis and pericarditis have been reported in the United States after mRNA COVID-19 vaccination, particularly in adolescents and young adults.

CDC continues to recommend COVID-19 vaccination for everyone 6 months and older, given the risk of COVID-19 illness and related, possibly severe complications, such as long-term health problems, hospitalization, and even death.

Vaccination is important because the risk of myocarditis or pericarditis associated with SARS-CoV-2 infection is greater than the risk of myocarditis or pericarditis occurring after receipt of an mRNA COVID-19 vaccine in adolescents and adults. However, people who develop myocarditis or pericarditis after a dose of an mRNA COVID-19 vaccine generally should not receive a subsequent dose of any COVID-19 vaccine. For more information see COVID-19 vaccination and myocarditis and pericarditis.

Health care providers should consider myocarditis in an evaluation of chest pain after vaccination and report all cases to the Vaccine Adverse Event Reporting System (VAERS) in a timely manner.

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program that has been used to detect possible safety issues with vaccines for many decades. Anyone can, but medical providers must, report adverse events (possible side effects or health problems) that occur after vaccination using VAERS.

It is a requirement that you submit all vaccine administration errors and adverse events to VAERS. Be sure to familiarize yourself with the specific EUA reporting requirements including:

• Vaccine administration errors whether or not associated with an adverse event
• Serious adverse events (irrespective of attribution to vaccination)
• Cases of Multisystem Inflammatory Syndrome (MIS) in adults
• Cases of COVID-19 that result in hospitalization or death.

Health care personnel or health departments in the U.S. can request a consultation from the Clinical Immunization Safety Assessment (CISA) COVIDVax project for a complex COVID-19 vaccine safety question about an individual patient residing in the U.S. not readily addressed by CDC guidance.

Request a consultation from CISA by:

For more information about vaccine safety, review What Every Clinician Should Know about COVID-19 Vaccine Safety. You can also read more about current data on adverse events, local and system reactions to Moderna and Pfizer COVID-19 vaccines.

Email us if you have more questions about vaccine safety or reporting adverse events.

Step 1: Check the Wisconsin COVID-19 Vaccine Exchange to see if another provider has COVID-19 vaccine to redistribute to you.

1. Please check and use this tool prior to ordering COVID-19 vaccine through the COVID-19 Vaccine Ordering Survey.
   • All providers are encouraged to offer and accept redistributed doses, regardless of the probability of wastage.
   • Requesting vaccine through the Wisconsin COVID-19 Vaccine Exchange is the only way you can order doses in smaller increments than those provided by manufacturers.
   • The recorded webinar from June 8, 2021 includes an overview and background information about the Wisconsin COVID-19 Vaccine Exchange, starting at minute 16:00.
2. Using the Request Vaccine form on the bottom right of the Vaccine Exchange page, identify the row ID of the offering vaccinator you would like to match with.
3. Once a match is made, both vaccinators will receive an email with contact information to take next steps.
   • Vaccinators are responsible for working together to redistribute the COVID-19 vaccine. This includes ensuring both entities have approved Redistribution Forms, arranging the transportation according to storage and handling guidelines, and completing the transfer in WIR.
   • If you need to remove your listing, please request the vaccine using the Request Vaccine Form, fill out the appropriate fields, enter in your row ID, and ask for zero doses. Click submit, then refresh the page. This will remove your listing.

Step 2: For additional vaccine, order COVID-19 vaccine through the COVID-19 Vaccine Ordering Survey.

Note for Vaccines for Children (VFC) and Vaccines for Adults providers: this process is different than ordering vaccine for those two programs.

1. Click on the link to the COVID-19 Vaccine Ordering Survey. You may also bookmark the direct link as it will not change.
2. Order a monthly supply of COVID-19 vaccine.
3. After completion and submission of a request through the COVID-19 Vaccine Ordering Survey, a “Download” button message will appear near the bottom of the screen. DHS is encouraging vaccinators to click on the “Download” button to save a PDF of the submission for their records.
4. If you have questions, issues, or the need to change or cancel an order, email DHSCovidVaccinator@wi.gov. The request to change or cancel an order must be received no later than noon on Tuesdays. Changes cannot be made after this time. Orders submitted after noon on Tuesdays will be held and processed the following week.

Order delivery timelines

Orders are processed weekly on Wednesdays. Vaccine orders submitted after 12 p.m. on Tuesdays will be held and processed the following Wednesday.

Please allow three to four business days to receive your order.

Take every opportunity to vaccinate

When faced with situations in which the choice is between opening a vial for a few individuals and assuming waste or asking that individuals return another day, DHS encourages all vaccinators to prioritize vaccination. Every individual counts, and we need to leverage every opportunity to vaccinate to the fullest.

Vaccine wastage reporting process

Only report COVID-19 vaccine wastage to the Wastage Form, F-02768 if the doses expired per the actual expiration date.

1. Check posted manufacturer information for the most up to date expiration/extension information for Pfizer-BioNTech, Moderna, and Novavax COVID-19 vaccines. Manage your vaccine inventory and update the expiration dates accordingly in WIR when there is an extension.
2. If the doses are expired per the expiration date, fill out the Wastage Form, F-02768 for the COVID-19 vaccine that has passed its expiration date. These expired doses should not be reported in WIR.
3. Email the Wastage form to the DHSCovidVaccinator@wi.gov and put “EXPIRED” in the subject line of the email.

Report all other COVID-19 vaccine wastage to WIR (but do not fill out a wastage form) if doses are:

• Gone past the beyond-use date (BUD).
  • BUD is different from the expiration date and is defined as the amount of time allowed by the manufacturer for a vaccine to be used after being punctured, reconstituted, or moved from a freezer to a refrigerator.
    • Vial punctured, but not used in appropriate timeframe per manufacturer instructions
      • Enter as Doses Wasted in WIR with the Reason: Open Vial, Not all Doses Administered.
    • Unpunctured vial past its BUD
      • Enter these as Doses Wasted in WIR. Use the Reason: “Other” code and enter "BUD" in the description.
  • Do not replace the expiration date in WIR with the BUD.
    • Mark the BUD on the package or vial when changing storage temperature and note the beyond-use date and time once the vial is first punctured.
    • When vaccine expires per the BUD, it is entered as wastage in WIR.
    • See the COVID-19 Vaccine: Quick Reference Guide for more information about BUDs.
• Unable to be drawn from a vial.
  • Enter these as Doses Wasted in WIR. Use the Reason: “Other” code and enter "only able to administer 'x' doses from vial" in the description.
  • Calculate waste by counting the total number of doses administered, regardless of volume or series, and subtracting this from the total number of identified doses in the vial. Standard doses per vial – number of vaccines administered = waste
    • Always report wastage in full doses based on the volume identified on the label. Never report wastage in half doses.
• Spoiled due to temperature excursions.
  • The vaccines that were exposed to out-of-range temperatures must be labeled “do not use” and stored at the required temperature until further information on usability can be gathered or further instruction on disposition or recovery is received.
  • The temperature excursions must also be reported to the manufacturers.
  • Never use the “Doses spoiled” code in WIR for COVID-19 vaccines as that data does not get reported to CDC. If doses are spoiled (exposed to temperature excursions), enter them as Doses Wasted in WIR. Use the Reason: Other code and enter “temperature excursion” in the description.
• Not able to be used for any other reason.
  • If vaccine doses are left unused for any other reason, enter them as Doses Wasted in WIR. Use the Reason: “Other” code and write a brief description in the free text box.

COVID-19 vaccine never gets returned to the state regardless of expiration date or wastage reason. It should always be disposed of per the facility’s policy.

Refer to CDC's Identifying, Disposing, and Reporting COVID-19 Vaccine Wastage webpage for additional guidance. This waste management guidance should not be used for non-COVID-19 vaccines, which are covered under other CDC vaccination programs.

Please remember to:

• Promptly add administered doses to WIR.
• Update inventory daily in WIR.
• Check inventory for accurate expiration dates and update in WIR.
• Do not stockpile; order only what you need.
• Use the Wisconsin COVID-19 Vaccine Exchange to reduce wastage and to assist DHS in monitoring statewide vaccine availability and supply.

Inventory management

To better maintain vaccine storage space, providers are encouraged to:

• Inventory status must be reconciled daily in accordance with your COVID-19 provider agreement. Update your inventory in WIR at the close of each business day to ensure that your physical inventory count matches your WIR inventory. This ensures the publicly posted amount on Vaccines.gov reflects actual inventory on hand. This will help to reduce confusion and assist the public in identifying a location where they can receive a vaccine.
• Stay aware of expiration dates and plan ahead to redistribute vaccine, if needed.
  • Mark the beyond-use date on the package or vial when changing storage temperature and note the beyond-use date and time once the vial is first punctured.
  • Monitor expiration dates weekly, rotate stock as needed, and follow a “first in, first out” strategy to manage inventory.
  • If nearing expiration, check posted manufacturer information for the most up to date expiration/extension information for Pfizer-BioNTech,Moderna, and Novavax COVID-19 vaccine lots.
  • Redistribute vaccine to other providers by posting COVID-19 vaccine on the Wisconsin COVID-19 Vaccine Exchange. Vaccine supply cannot be returned to DHS. It can only be redistributed to other enrolled providers.
• Reduce vaccine ordering, reduce inventory, and place orders on an “as-needed” basis.
  • In most instances, vaccine orders of existing COVID-19 vaccines can be delivered within 48 hours.
  • Assess storage space to determine freezer and refrigerator capacity before placing orders for vaccine, considering anticipated flu vaccine inventory as appropriate.
• Remove expired vaccine from the storage unit immediately, based on the latest expiration information. Do not give staff the opportunity to administer expired vaccine.
  • If expired vaccine is inadvertently administered, it is considered a vaccine administration error and requires remediation including a Vaccine Adverse Event Reporting System (VAERS) report, contacting the recipient to inform them of the error, and may or may not require revaccination based on the manufacturers’ guidance. See CDC's guidance on vaccine administration errors and deviations.
  • Vaccine disposal: dispose of the vaccine vial (with any remaining vaccine) and packaging as medical waste according to your facility’s policy. COVID-19 vaccine does not get returned to the state. Do not return vaccine in the thermal shipping container.

The printed information on COVID-19 vaccine packaging may be different from what will be stated on the EUA fact sheets. Always follow the information in the latest EUA fact sheet over the printed vial label.

Vaccinators are encouraged to immediately report any issues with equipment in the ancillary kits that are shipped with their federal vaccine orders. Please be prepared to provide photos, lot number, order number, date ordered, and dates received when filing a report for a deficient ancillary kit.

1. Report ancillary kit issues and deficiencies to McKesson. Their customer service desk is charged with responding to problems and identifying trends.
   • For Pfizer COVID-19 vaccine ancillary kit problems, email McKesson MedSurg: snssupport@mckesson.com.
   • For Moderna or Novavax COVID-19 vaccine ancillary kit problems, contact McKesson Specialty by phone 833-343-2703 or email: covidvaccinesupport@mckesson.com.
2. If an error or injury occurs during vaccine administration, enter the information into Vaccine Adverse Event Reporting System (VAERS).
3. Because syringes are a medical device, complete FDA form 3500.

Useful tools and resources for vaccine redistribution

• COVID-19 Vaccinator Enrollment Tool
• Guide to filling out the COVID-19 vaccine Redistribution Form (PDF)
• Provider Registration Scenarios: When to Submit a Form B (PDF)
• Managing Transfers in WIR training video
• Wisconsin COVID-19 Vaccine Exchange and overview and background information about the tool starting at minute 16:00 of the recorded webinar from June 8, 2021.

Steps to redistribute vaccine

Note: Organization refers to the provider listed on Form A, and location or site refer to the provider listed on Form B.

1. Ensure a provider agreement (Form A and Form B) is on file and approved for your location.
   • If your location has a Pandemic PIN and has been ordering vaccine, this can serve as confirmation.
   • Otherwise, email DHSCovidVaccinator@dhs.wisconsin.gov for confirmation.
2. Ensure a Redistribution Form is on file and approved for your organization.
   • A COVID-19 vaccine provider organization only needs to fill out one Redistribution Form. Once the Redistribution Form is approved and on file, the organization can redistribute vaccine to other approved entities and locations. Check to see if you received an approval email from DHSCovidVaccinator@wi.gov or email DHSCovidVaccinator@wi.gov for confirmation.
   • Make sure your Redistribution Form includes the current Chief Medical Officer’s (CMO) and Chief Executive Officer’s (CEO) e-signature and matches your organization's Form A.
     • If you need to update the information on your Provider Enrollment forms, please submit an email request to change information to your forms to DHSCovidVaccinator@wi.gov. You must include the location or organization name listed on your original forms in the subject line. Then include what information you need changed in the body of the email.
   • If your organization does not have a Redistribution Form on file, generate and submit a Redistribution Form on the COVID-19 Vaccinator Enrollment Tool. See the guide to filling out the COVID-19 vaccine Redistribution Form, P-03015.
     1. Login to the enrollment tool using your Department of Administration (DOA)/Wisconsin Logon credentials.
     2. Locate the Redistribution Form at the bottom of the enrollment tool and complete it.
     3. Submit the Redistribution Form and wait for provider enrollment staff to reach out for corrections or with your approval email.
3. While waiting for the approval of your Redistribution Form, find an enrolled COVID-19 vaccine provider to redistribute vaccine to using the Wisconsin COVID-19 Vaccine Exchange.
   • Complete the Offer Vaccine Form on the bottom right of the Vaccine Exchange page and click submit.
   • Refresh the page after submitting to see your entry placed.
   • If another vaccinator requests to use your vaccine, you will receive an email with contact information for next steps.
   • If you need to remove your listing, please request the vaccine using the Request Vaccine Form, fill out the appropriate fields, enter in your row ID, and ask for zero doses. Click submit, then refresh the page. This will remove your listing.
4. Once you have identified an enrolled COVID-19 vaccine provider to accept your vaccine, ensure the receiving location also has an approved provider agreement (Form A and Form B). Email the receiving location or DHSCovidVaccinator@dhs.wisconsin.gov for confirmation.
5. Once you have received approval for redistribution and partnered with a receiving provider, initiate an electronic transfer in WIR between your two organizations.
   • When setting up a transfer, the initiating provider chooses the organization the vaccine is going to, not the site. It is the responsibility of the receiving provider to make sure that the vaccine gets accepted into the correct COVID-19 configured site. For more guidance, see the Managing Transfers WIR training video.
6. If you are receiving the transfer, make sure to accept the electronic transfer in WIR upon receipt of the shipment. This step will automatically add the vaccine to your inventory. Do not add the inventory manually.
7. Redistribute any unused COVID-19 vaccine.
   • Vaccinators are responsible for arranging the transportation of doses according to storage and handling guidelines.
8. If additional support is needed, please contact DHSCovidVaccinator@dhs.wisconsin.gov.

COVID-19 vaccination cards have been stolen, fraudulently reproduced, and illegally sold to reflect full vaccination for someone who has not received a COVID-19 vaccine. There have also been reported incidents of stolen and lost vaccine vials.

Report suspected fraud and theft incidences to your local law enforcement agencies, the HHS Office of Inspector General, and/or the FBI as listed below:

• HHS Office of Inspector General (1-800-HHS-TIPS or oig.hhs.gov)
• Federal Bureau of Investigation Electronic Tip Form (tips.fbi.gov)