Is there a cost to providers to receive and administer the vaccine?
There is no cost for the vaccine or ancillary kits. The U.S. Centers for Medicare and Medicaid Services (CMS) has approved reimbursement for the administration of the vaccine. While vaccine providers may not bill for the COVID-19 vaccine itself, many vaccine providers in the state have contracted with outside entities, such as Commonwealth Medicine, to assist with insurance billing for the costs of administering the vaccine. The Department is not a party to these agreements, but if your site has such an agreement you may wish to familiarize yourself with its terms.
Does the Massachusetts COVID-19 Vaccine Program provide up-front funding to administer COVID-19 vaccine?
At this time, there is no up-front funding for administration-related costs through the federal government or from the state. Vaccine and some related supplies (syringes, needles) are being supplied by the federal government. Providers may bill Medicare, Medicaid, and private insurers for the cost of administering COVID-19 vaccine. For more information, please see COVID-19 Vaccine Coverage and Reimbursement Update from the Massachusetts Medical Society.
Does FEMA provide funding to cover vaccination costs?
Yes, eligible Applicants under the FEMA Public Assistance (PA) Program may seek 100% reimbursement for uncovered vaccination costs. Eligible Applicants include state, local, and tribal governments along with not-for-profit healthcare providers, Boards of Health, and other quasi-governmental agencies. The PA Program is administered through the Massachusetts Emergency Management Agency (MEMA). For more information you can visit MEMA’s website, or email your questions to email@example.com.
Is there a cost to vaccine recipients?
Providers must administer COVID-19 Vaccine regardless of the vaccine recipient’s ability to pay administration fees or the recipient’s insurance coverage status. Providers may seek appropriate reimbursement from a program or plan that covers COVID-19 Vaccine administration fees for the vaccine recipient. Providers may not seek co-payment, reimbursement or any form of cost sharing, including through balance billing, from the vaccine recipient.
Is the COVID-19 vaccine mandated by DPH?
No, the COVID-19 vaccine is not mandated by DPH. It is a voluntary vaccination program. The COVID-19 vaccine has been shown to be highly effective at preventing illness and it is an important tool in the fight against the pandemic.
Is consent needed for COVID-19 vaccination? (Updated 4/15/21)
Informed consent is a vital process prior to the administration of a vaccine. Vaccine providers should consult with their legal counsel regarding an appropriate informed consent process and what documentation may be recommended or required by their particular organization. Information regarding informed consent for minors is provided below.
What procedure should a vaccine provider follow to obtain consent to administer a COVID-19 vaccine to someone who is under 18? (New 4/15/21)
It is the responsibility of vaccine providers to obtain appropriate consent from patients before administering a vaccination. The expectation is that every vaccine provider in the Commonwealth will establish appropriate procedures which minimize hurdles to vaccination for minors, and make those requirements, including any required forms, easy to understand and accessible.
For minors, consent is obtained from a legally authorized representative on behalf of the child (usually a parent or guardian). The legally authorized representative does not need to accompany the minor to the vaccination appointment in order to provide consent for a vaccination. Vaccine providers are strongly encouraged to request written consent from the appropriate legally authorized representative, such as a written consent form, that the minor may then bring to their vaccine appointment. A model consent form is available here for providers to utilize for this purpose.
What information do we need to provide vaccine recipients about the US FDA Emergency Use Authorization (EUA) of the COVID-19 Vaccines?
The Moderna, Pfizer, and Janssen (Johnson & Johnson) COVID-19 Vaccine Letters of Authorization (Letters) which describe the terms of the EUA, Fact Sheet for Healthcare Providers Administering Vaccine (provider fact sheet), and Fact Sheet for Recipients and Caregivers (recipient fact sheet) in addition to other related documents and translations of the fact sheet are available here:
- Moderna COVID-19 Vaccine | FDA
- Pfizer-BioNTech COVID-19 Vaccine | FDA
- Janssen COVID-19 Vaccine | FDA
The Letters, fact sheets, and other related documents and translations of the fact sheet should be carefully reviewed. The Letters also place obligations on vaccine providers. It is important to review the documents from the linked FDA site so that you have access to any updates or amendments.
Facilities, organizations, and healthcare providers holding vaccination clinics, as vaccination providers, should carefully review the Letter of Authorization and the provider and recipient fact sheets for the particular vaccine they will be administering. The Letter places obligations on vaccination providers including administering the vaccine in accordance with the EUA, making the recipient fact sheets available to each individual receiving the vaccine, and reporting certain information to the Vaccine Adverse Event Reporting System (VAERS).
Do we need a standing order for COVID-19 vaccine clinics? (Updated 4/28/21)
Yes, you need to obtain a standing order for your program from a medical professional, such as a physician.
- State law, M.G.L. c. 94C, section 8 (7), requires a licensed provider with prescribing authority to issue an order for administration of a vaccine such as the COVID-19 vaccine.
- Authorized ordering providers include, a: physician, chiropractor, surgeon, podiatrist, osteopath, nurse practitioner, dentist, or physician’s assistant. See MGL Ch. 94C; 105 CMR 700.00.
- A standing order is an order issued by a licensed provider, which is not specific to one person, and enables assessment and vaccination of patients without the need for clinician examination or direct order from the attending provider at the time of the interaction.
- Model standing orders developed by CDC can be found here for the Moderna COVID-19 vaccine, here for the Pfizer COVID-19 vaccine, and here for the Janssen COVID-19 vaccine.
- Other Emergency Treatment Standing order templates are available from the Immunization Action Coalition:
What liability protections do COVID-19 vaccinators have?
People or entities with liability or other legal questions should consult with their legal counsel. You and your legal counsel may wish to review the federal Public Readiness and Emergency Preparedness Act (PREP Act) and/or the Massachusetts Act to Provide Liability Protections for Health Care Workers and Facilities During the COVID-19 Pandemic.
Can healthcare providers submit claims for uninsured individuals who are undocumented?
Health care providers are not required to confirm immigration status prior to submitting claims for reimbursement. Health care providers who have conducted COVID-19 testing of any uninsured individual, provided treatment to any uninsured individual with a COVID-19 primary diagnosis, or administered a licensed or authorized COVID-19 vaccine to an uninsured individual for dates of service or admittance on or after February 4, 2020, may be eligible for claims reimbursement through the program as long as the service(s) provided meet the coverage and billing requirements established as part of the program. (source: FAQs for COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment and Vaccine Administration, hrsa.gov)
Can people who live in Massachusetts but work in another state receive vaccine in Massachusetts? How about those who work in Massachusetts but live in another state?
Yes. The Massachusetts COVID-19 Vaccination program is intended for individuals who live, work or study in the state.
Who can administer vaccine?
This COVID-19 Vaccinators chart lists the different groups of individuals who can possess and administer COVID-19 vaccines.
DPH strongly encourages the primary and back-up vaccine coordinators at each site and providers administering COVID-19 vaccine to complete the trainings in vaccine storage and handling and administration found at Massachusetts COVID-19 Vaccine Program (MCVP) Overview | Mass.gov.
How will patients know which vaccine they receive and, if applicable, when they need the second dose?
The vaccine ancillary supply kits will come with vaccine record cards that can be given to the patients indicating what vaccine they received and, if applicable, that they need a second dose. Vaccine record cards may be reproduced, if necessary. In addition, there will be electronic reminder/recall systems in the MIIS that providers could use in addition to their own EHR systems to send reminders to patients about their second dose. More information about the v-safe app, which also includes a patient reminder recall, can be found at V-safe After Vaccination Health Checker | CDC. Providers should schedule the 2nd dose at the time the 1st dose is administered.
What should a site do if a vaccine recipient has lost or misplaced their COVID-19 Vaccination Record Card?
Vaccine recipients should be encouraged to obtain a record of their immunization record directly from the administering provider or site.
Administering providers and vaccination sites can create a new record card for the recipient. They can order blank COVID-19 Vaccination Record Cards in English and Spanish from the Massachusetts Clearing House at no cost and use the recipient’s vaccine records (either the electronic health record or MIIS) to fill out a replacement card.
If a provider or site does not have access to the patient’s electronic health record, they may access the patient’s immunization record in the MIIS. This Mini Guide provides step-by-step instructions for providers to access and print a patient’s immunization record in the MIIS. Please note that the MIIS cannot provide patients with COVID-19 Vaccination Record Cards.
Providers and vaccination sites can also advise vaccine recipients on the following options:
- They may be able to print their electronic health record directly from their provider’s health care portal.
- They can access their record in v-safe, if they enrolled in the program.
Both the Pfizer and Moderna COVID-19 vaccine require 2 doses.
- Pfizer-BioNTech (30 µg, 0.3 ml each): at least three weeks (21 days) apart
- Moderna (100 µg, 0.5 ml): at least one month (28 days) apart
Second doses administered within a grace period of 4 days earlier than the recommended date for the second dose are still considered valid. If it is not feasible to adhere to the recommended interval and a delay in vaccination is unavoidable, the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines may be administered up to 6 weeks (42 days) after the first dose. Currently, only limited data are available on efficacy of mRNA COVID-19 vaccines administered beyond this window.
For COVID-19 vaccines requiring 2 doses, the 2nd dose must be the same vaccine product as the first dose. If two doses of different mRNA COVID-19 vaccine products are inadvertently administered, no additional doses of either vaccine are recommended at this time
Recommendations may be updated as further information becomes available or additional vaccine types authorized.
What role should long-term care/skilled nursing and correctional facilities play in ensuring access to second doses for individuals who leave their facilities?
Anyone receiving their first dose of vaccine in a LTCF/SNF or correctional facility is eligible for a second dose after they leave. LTCF/SNFs and correctional facilities should make every effort to support individuals to plan for their second dose before they leave the facility. This can include making an appointment at a publicly available clinic (see vaxfinder.mass.gov) or directing the individual to other options the facility manages. Individuals should always be given a vaccination card indicating the manufacturer, lot, date administered, and the date the second dose is due. It is best practice that the administrator of the first dose actively supports individuals to receive the second, even if they cannot administer it directly.
What should a site do with extra vaccine?
Vaccine can be transferred to sites that have completed an MCVP Agreement. Please note that this does not apply to temporary off-site clinics. Such a transfer must be done in consultation with the Vaccine Unit. Visit Massachusetts COVID-19 Vaccine Program (MCVP) – Guidance for Vaccine Providers and Organizations | Mass.gov for more guidance on redistribution.
Vaccinators should withdraw only the authorized number of doses from each vial of COVID-19 vaccine. The number of authorized doses is indicated on the vaccine packaging in the provider EUA fact sheet for each vaccine. The actual number of doses that a vaccinator can get from each vial may be affected by the type of needle and syringe used. If less than the number of authorized doses is used by the Beyond Use Date (BUD), the vial and remaining vaccine must be discarded in a sharps container. With Pfizer and Janssen (J&J) vaccine, any doses not used must be reported as wasted. For Moderna vaccine, an unextracted 15th dose in a maximum-15 dose vial does not count as waste.
What is our obligation to follow the Emergency Use Authorization (EUA) terms and principles of non-discrimination in administration?
Providers must follow the EUA. Decisions about which eligible patients receive the COVID Vaccine should be based on the clinical judgment of hospitals and providers, consistent with the terms of the EUAs and with this guidance. Provider criteria for the COVID Vaccine use should be as clear, transparent, and objective as possible, and be based on biological factors related only to the likelihood and magnitude of benefit from the medical resources and should at all times minimize inequitable outcomes. Factors that have no bearing on the likelihood or magnitude of immunization benefit, include but are not limited to, race, disability, gender, sexual orientation, gender identity, ethnicity, ability to pay or insurance status, socioeconomic status, English language proficiency, perceived social worth, perceived quality of life, immigration status, incarceration status, homelessness, or past or future use of resources.
What happens if a vaccine recipient does not receive a full dose or the dose is given subcutaneously (SC), not intramuscularly (IM)?
- If a lower-than-authorized dose volume was administered (e.g., leaked out, equipment failure, recipient pulled away):
- If more than half of the dose was administered do not repeat the dose.
- If less than half of the dose was administered or the proportion of the dose cannot be estimated, administer the authorized dose immediately (no minimum interval) in the opposite arm. If the dose given in error is the first dose of a two-dose series, the second dose should be administered at the recommended interval (21 days [Pfizer-BioNTech] or 28 days [Moderna]) from the date of receipt of the valid dose (not the date of receipt of the erroneous dose).
- If a dose is given by an incorrect route, e.g., subcutaneously, do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.
- Report all COVID-19 vaccination errors to VAERS.hhs.gov.
Will a person test positive for COVID-19 after getting the vaccine?
None of the recently authorized and recommended vaccines nor the other COVID-19 vaccines currently in clinical trials in the United States can cause you to test positive on viral tests, which are used to see if you have a current infection. Viral tests (molecular [e.g., PCR] or antigen) to detect current infection will still be accurate if you have been vaccinated.
If your body develops an immune response—the goal of vaccination—there is a possibility you may test positive on some antibody tests. Antibody tests look for evidence of a previous infection and that you may have some level of immunity to the virus. Experts are currently looking at how COVID-19 vaccination may affect antibody testing results.
Should someone who is COVID-19-positive receive the vaccine?
Vaccination of persons with known current SARS-CoV-2 infection should be deferred until their isolation period has ended, usually 10 days after their symptoms began or their test was positive (if asymptomatic) While there is otherwise no recommended minimum interval between infection and vaccination, current evidence suggests that reinfection is uncommon in the 90 days after initial infection.
Is it safe for people to get a COVID-19 vaccine if they would like to have a baby one day?
Yes. People who want to get pregnant in the future may receive any of the COVID-19 vaccines. Based on current knowledge, experts believe that COVID-19 vaccines are very unlikely to pose a risk to a person trying to become pregnant in the short or long term. Scientists study every vaccine carefully for side effects immediately and for years afterward. The COVID-19 vaccines are being studied carefully now and will continue to be studied for many years, similar to other vaccines.
The COVID-19 vaccine, like other vaccines, works by training our bodies to develop antibodies to fight against the virus that causes COVID-19, to prevent future illness. There is currently no evidence that antibodies formed from COVID-19 vaccination cause any problems with pregnancy, including the development of the placenta. In addition, there is no evidence suggesting that fertility problems are a side effect of ANY vaccine. People who are trying to become pregnant now or who plan to try in the future may receive the COVID-19 vaccine when it becomes available to them.
Can the COVID-19 vaccines be given to people who are pregnant? (Updated 6/1/21)
- Yes. Any of the currently authorized COVID-19 vaccines can be administered to pregnant or lactating people; ACIP does not state a product preference.
- There are limited data on the safety of COVID-19 vaccines in people who are pregnant. Early data from v-safe and VAERS did not identify any safety concerns for pregnant people who were vaccinated or for their babies. There were no vaccine-related adverse events reported on female fertility, fetal development or postnatal development from animal studies with all 3 vaccines.
- COVID-19 infection during pregnancy can result in an increased risk of severe illness (ICU admission, mechanical ventilation and death) and might result in an increased risk of adverse pregnancy outcomes, such as preterm birth.
- Consider the following when discussing COVID-19 vaccination with people who are pregnant:
- Level of COVID-19 community transmission (risk of acquisition)
- Personal risk of contracting COVID-19
- The risks of COVID-19 to the person who is pregnant and potential risks to the fetus
- The efficacy of the vaccine
- The known side effects of the vaccine
- The limited but growing data about the vaccine during pregnancy
- Pregnant people who experience fever following vaccination should be counseled to take acetaminophen as fever has been associated with adverse pregnancy outcomes.
- Routine testing for pregnancy prior to receipt of a COVID-19 vaccine is not recommended.
- For more information, visit Interim Clinical Considerations for Use of COVID-19 Vaccines.
How can we balance potential side effects of the vaccine with healthcare providers needing to be available to work?
Systemic signs and symptoms, such as fever, fatigue, headache, chills, myalgia, and arthralgia, can occur following COVID-19 vaccination. Preliminary data from COVID-19 vaccine trials indicate that most systemic post-vaccination signs and symptoms are mild to moderate in severity, occur within the first three days of vaccination (the day of vaccination and following two days, with most occurring the day after vaccination), resolve within 1-2 days of onset, and are more frequent and severe following the second dose and among younger persons compared to those who are older (>55 years). Cough, shortness of breath, rhinorrhea, sore throat, or loss of taste or smell are not consistent with post-vaccination symptoms, and instead may be symptoms of COVID-19 or another infection.
DPH guidance about Considerations for Health Care Personnel After COVID-19 Vaccination can be found here.
If we obtain capacity for storing at ultra-cold temperatures after we have submitted information to MIIS that we did not have capacity, what is the best way to update the system?
If there is any change in your storage capacity, please email the DPH Vaccine Unit at firstname.lastname@example.org to update your information.
We are planning as a system and exploring central storage for our entities. How should we fill out the DPH and CDC forms regarding capacity within each type of storage (i.e. ultra-cold)? Will it be possible for us to receive all at one storage location?
You must enroll each location and note “ultra-cold” storage capacity at each location. DPH can work with you to have all of your site’s supply forwarded to the central ultra-cold storage location.
Should vaccination sites have security for vaccine inventory?
Vaccination sites are responsible for maintaining vaccine inventory delivered to the site secure. However, armed security guards or special security details are not required.
What credentials are required of individuals responsible for receiving vaccine shipment, managing inventory, and serving as vaccine coordinators and backup coordinators?
No credentials are required, but the individual must participate in required trainings (see question 32). The vaccine coordinator and back-up coordinator should be employees or contractors of the entity that is enrolled in the MCVP and receiving the vaccine.
Pharmaceutical and purpose-built refrigerators are a vaccine storage and handling best practice but are not required for the storage of COVID-19 vaccine. Standalone freezers are strongly recommended, as the freezer portion of a household combination unit may not reliably maintain temperatures. If that is not possible for your site, please contact the Vaccine Unit at DPH-Vaccine-Management@massmail.state.ma.us for further guidance to ensure maintenance of appropriate temperatures. All storage units must be monitored continuously. The best practice for monitoring temperatures is to use a digital data logger available from DPH.
MIIS registration, enrollment, and training
Should we ask our sites to update their information stored in MIIS Vaccines module to be that of our central depot or will this be something we can address separately?
No, please do not ask sites to update their vaccine information in the vaccine module as that will result in all routine vaccines now being shipped to the new location. We will develop a separate mechanism to capture the necessary information we need for hospital networks that will be using a central depot model.
Can the MIIS be used for pulling patient lists for defined prioritization based on age and higher risk diagnoses, for ease of outreach?
Providers can use the MIIS to run two reports that list patients by age - the Practice Population Report and the Patients Vaccinated Report. The Practice Population Report allows you to enter an age range. You can sort by birthdate on the report output. On the Patients Vaccinated Report you can also enter an age range, or leave it blank to run it by administration date or by vaccines the patients have received, and then sort by birthdate on the output.
My site administers immunizations directly. Am I required to register with and report data to the MIIS?
Yes. Reporting of immunization data to the MIIS is required by state law for all MA health care provider practices. You should register with the MIIS at the following website: www.miisresourcecenter.com. Registration with the MIIS also requires an onboarding process to ensure capacity to complete the required reporting and place vaccine orders directly through the MIIS. In order to receive COVID-19 vaccine, your site should:
- Confirm that your facility is fully registered and on-boarded to submit vaccine-administered data to the Massachusetts Immunization Information System (MIIS): email@example.com
- Confirm that your facility has signed and electronically submitted the Massachusetts COVID-19 Program (MCVP) Enrollment Form: DPH Vaccine Unit, firstname.lastname@example.org
How can my facility confirm that we are listed as a vaccine provider with DPH and are able to receive vaccine once it is available?
Confirm that your facility is fully registered and on-boarded to submit data about administered vaccine to the MIIS by contacting the MIIS team MIIShelpdesk@state.ma.us. Confirm that your facility has signed and electronically submitted the Massachusetts COVID-19 Provider (MCVP) Enrollment Form in the MIIS by contacting the DPH Vaccine Unit at email@example.com.
If a hospital has an urgent care center, should each site enroll separately or just the hospital?
All individual locations will need to enroll separately but sites will be receiving invitations directly as MCVP enrollment rolls out to additional provider locations.