HHS Announces HIPAA Enforcement Discretion for Scheduling of COVID-19 Vaccination Appointments |
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The Office for Civil Rights (OCR) at the U.S Department of Health and Human Services (HHS) announced last week that it will exercise its enforcement discretion and will not impose penalties for violations of the Health Insurance Portability and Accountability Act (HIPAA) Rules on covered health care providers or their business associates in connection with the good faith use of online or web-based scheduling applications (collectively, “WBSAs”) for the scheduling of individual appointments for COVID-19 vaccinations during the COVID-19 nationwide public health emergency. According to a recent HHS press release, this exercise of enforcement discretion is effective immediately, but has retroactive effect to Dec. 11, 2020.
The notification explains that the exercise of enforcement discretion applies to covered health care providers and their business associates, including WBSA vendors, when the WBSA is used in good faith and only for the limited purpose of scheduling individual appointments for COVID-19 vaccinations during the COVID-19 nationwide public health emergency. Although OCR is exercising enforcement discretion, the notification encourages the use of reasonable safeguards to protect the privacy and security of individuals’ protected health information (PHI), such as using only the minimum necessary PHI, encryption technology, and enabling all available privacy settings.
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Preliminary Timeline for Receiving COVID-19 Vaccine
Everyone should begin to plan how they will receive the vaccine, but for many it will likely be several months before they are eligible. In the meantime, everyone is encouraged to start having conversations with their health care provider about getting vaccinated, according to the Michigan Department of Health and Human Services (MDHHS).
The timing of the start of a vaccination phase is dependent on the guidance from the Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP), supply of vaccine from the manufacturer, how vaccine is allocated from the federal level to Michigan, and capacity to administer vaccinations. For more detailed information, review the COVID-19 Vaccine Prioritization Guidance.
Based on information currently available, Michiganders can expect to become eligible to receive vaccine based on the Prelimary COVID-19 Vaccination Timeline, below.
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Monoclonal Antibody Therapies Available For Treating Mild to Moderate COVID-19 |
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While the safety and effectiveness of these investigational therapies appear promising, the data are still very limited. Clinical trials are ongoing to collect additional data on their safety and effectiveness.
To date, more than 2,000 Michiganders have received monoclonal antibodies in their course of treatment for COVID-19. A physician’s order is required, though it may vary from site to site as each hospital/system is running things a little differently. Some are infusing at their emergency department after consult with an emergency physician, while others are partnering with internal and/or external partners for delivery of the drug.
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A Message from Dr. Khaldun and Dr. Fales
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CDC COVID-19 Considerations: 2nd Dose & Interchangeability |
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Updated recommendations on intervals between the first and second dose
- Language has been added to clarify that doses inadvertently administered earlier than the grace period should not be repeated.
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Language has also been added that states “The second dose should be administered as close to the recommended interval as possible. However, if it is not feasible to adhere to the recommended interval, the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose. There are currently limited data on efficacy of mRNA COVID-19 vaccines administered beyond this window. If the second dose is administered beyond these intervals, there is no need to restart the series.”
Updated recommendations on interchangeability of vaccine products
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mRNA COVID-19 vaccines are not interchangeable. Language has been added to provide suggested strategies to help ensure patients receive the second dose with the appropriate product and interval between doses including:
- “Providing COVID-19 vaccination record cards to vaccine recipients, asking recipients to bring their card to their appointment for the second dose, and encouraging recipients to make a backup copy (e.g., by taking a picture of the card on their phone).
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Encouraging vaccine recipients to enroll in VaxText, a free text message-based platform to receive COVID-19 vaccination second-dose reminders.
- Recording each recipient’s vaccination in the immunization information system (IIS).
- Recording vaccine administration information in the patient’s medical record.
- Making an appointment for the second dose before the vaccine recipient leaves, to increase the likelihood that patients will present at the same vaccination site for the second dose.
Using the above strategies, every effort should be made to determine which vaccine product was received as the first dose, in order to ensure completion of the vaccine series with the same product. In exceptional situations in which the first-dose vaccine product cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimal interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time.
Updated language on vaccination of persons with a history of SARS-CoV-2 infection
Updated language includes:
- “Data from clinical trials indicate that mRNA COVID-19 vaccines can safely be given to persons with evidence of a prior SARS-CoV-2 infection.”
- “Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection for the purposes of vaccine decision-making is not recommended.”
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“While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Thus, while vaccine supply remains limited, persons with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination, if desired, recognizing that the risk of reinfection, and therefore the need for vaccination, may increase with time following initial infection.”
New vaccination recommendations with a history of dermal fillers
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Added language states “Infrequently, persons who have received dermal fillers may develop swelling at or near the site of filler injection (usually face or lips) following administration of a dose of an mRNA COVID-19 vaccine. This appears to be temporary and can resolve with medical treatment, including corticosteroid therapy. mRNA COVID-19 vaccines may be administered to persons who have received injectable dermal fillers who have no contraindications to vaccination. No additional precautions are needed. However, these persons should be advised to contact their healthcare provider for evaluation if they develop swelling at or near the site of dermal filler following vaccination.”
Additional resources on vaccine excipients (Appendix B)
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“The language added in Appendix B is “As of January 21, 2021, mRNA COVID-19 vaccines are the only currently available vaccines in the United States that contain PEG, though several vaccines contain polysorbate (more information can be found in CDC’s vaccine excipient summary).”
Source: CDC, Jan. 22, 2021
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Guidance on Handling of Moderna Vaccine |
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The Michigan Department of Health and Human Services (MDHHS) would like to further clarify Moderna’s COVID-19 vaccine shipment, transport and redistribution guidance. The Moderna COVID-19 vaccine may be shipped directly to sites in volumes of 100 doses per carton. Given the smaller shipment size compared to other vaccines, CDC recommends that each site administering vaccine receive a direct shipment. However, CDC recognizes that redistribution of vaccine may be required in some instances by jurisdictions, federal and pharmacy partners. Below is some transport guidance for Moderna COVID-19 vaccine.
Based on current guidance for the Moderna COVID-19 vaccine from the manufacturer and from the CDC, immunization planners should consider the following general principles for vaccine redistribution to avoid not transporting a punctured open MDV:
- Once a vial of vaccine has been thawed, it may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 30 days, prior to first use.
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Once thawed, the vaccine CANNOT be re-frozen.
- When thawed, the vaccine should be handled with care and protected from shocks, drops, vibration, etc.
- Vaccine being transported at temperatures other than frozen -25°C and -15°C (-13°F and 5°F), should begin with the vaccine in the frozen state if possible.
- A digital data logger (DDL) is required to be used to monitor temperatures whenever vaccine is being transported.
If you must transport vaccine that has already been thawed, follow these general principles:
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Do NOT transport punctured vials.
- Care must be taken to ensure vaccine does not re-freeze during transport.
- Vaccine must be protected as much as possible from drops, shocks and vibration whether in the carton, vial, case or cooler.
- Vaccine should be transported in the carton whenever possible.
- If transport must be conducted at the vial level, the vial should be placed with dunnage (padding material like bubble wrap or similar padding) to minimize movement during transport.
- The vaccine should always be transported in insulated containers qualified to maintain temperatures between 2°C and 8°C (36°F and 46°F) for the duration of transport.
- The transport containers must be secured when being transported to prevent unnecessary movement.
- After completion of transport, vaccine should immediately be placed into a vaccine storage unit at temperatures between 2°C and 8°C (36°F and 46°F).
- Vaccine should only be transported one time and should not be transported back to the point of origin or to a new location.
- Allowable timelines for transport of thawed vaccine are shown below. Total transport time should not exceed 12 hours in total.
- Transport while walking or using hand cart: not to exceed 1 hour.
- Vehicle transport: not to exceed 12 hours.
- Airplane transport (rotary wing aircraft not allowed): not to exceed 3 hours.
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Click here for additional guidance.
It is NOT recommended to predraw vaccine or to transport vaccine predrawn into the syringe by providers.
- Any pre-drawing of the vaccine should be done only after arriving at the clinic site or mass vaccination event.
- Each person administering vaccine should draw up no more than one MDV at a time.
- Monitor patient flow to avoid drawing up unnecessary doses.
- Never transfer predrawn vaccine back into a vial for storage.
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CDC’s Storage and Handling Toolkit has additional information on this subject.
Ensuring that COVID-19 vaccine is properly stored and transported is essential to vaccine safety and efficacy. For further information and guidance on Moderna vaccine and on vaccine storage and handling:
Looking for inventory guidance on redistribution? Use the following tip sheets to support inventory transactions for redistribution of COVID-19 vaccine:
As a reminder, before a site can redistribute COVID-19 vaccine to another location, the site conducting the redistribution must sign, submit and comply with the CDC COVID-19 Vaccine Redistribution Agreement. Both the redistributing site and the recipient site MUST be enrolled as COVID-19 Vaccine Providers with Outbreak inventories activated.
Lastly, reminders on ways to prevent waste of vaccine:
- When preparing for the off-site clinic, and in order to reduce any chance of vaccine being wasted, be sure to verify clinic date, time and location.
- Determine how many people are scheduled to show up to the clinic and verify this number.
- Pull only the amount of vaccine that you will need at this clinic and prepare it for transport.
- Create a list of people to have as a back-up in case someone does not show up or an extra dose is able to be pulled from a vial. Take that list with you to the clinic in order for you to call someone from the wait list to see if they could come in on short notice.
- It is important to do our due diligence in order to reduce any possibility of COVID-19 vaccine waste.
Additionally, the U.S Pharmacopeia (USP) has released a USP COVID-19 Vaccine Handling Toolkit to provide critical information to pharmacists, doctors, nurses, nurse practitioners, physician assistants, health profession students and others who are involved in handling COVID-19 vaccines.
Please direct Coronavirus (COVID-19) related inquiries to the DHHS COVID-19 hotline at 1-888-535-6136. For the most up-to-date information, facts and FAQs, go to www.michigan.gov/Coronavirus.
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MDHHS:
'Noontime Knowledge'
The Michigan Department of Health and Human Services (MDHHS) is hosting web-based COVID-19 updates every other week on specific hot topics with a question-and-answer session.
The next update will be held Thursday, Jan. 28, at noon. This discussion will cover prioritization guidance and allocation. This will be a 15- to 20-minute update with 10-15 minutes for questions.
Prior to this week’s update, feel free to review www.michigan.gov/COVIDvaccine and click "COVID-19 Vaccine Prioritization Guidance," which outlines the strategy for vaccine prioritization for the State of Michigan and will be used by MDHHS, as well as public health and health care, to allocate and administer vaccines. This guidance may change as information evolves and more vaccine types become available.
We will be using Zoom. To obtain meeting information, click the "REGISTER NOW" button below.
- At the registration page enter your name and email, and then click register.
- You will receive an email that states you are registered. In that email you will receive the information needed to attend the 'Noontime Knowledge' session.
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CDC TRAIN:
COVID-19 Vaccination Training
Many healthcare professionals administering COVID-19 vaccinations have extensive experience with immunization practices, but for others, this may be their first clinical experience with vaccination.
The Public Health Foundation has compiled a list of trainings provided in the Center for Disease Control and Prevention’s COVID-19 Vaccination Training Programs for Healthcare Professionals. These trainings provide basic, as well as COVID-19-vaccine-specific information.
FREE continuing education credit is available!
Learning Objectives:
After completing these trainings, participants will be able to:
- Outline general vaccine storage, handling and administration best practices.
- Explain safe vaccination injection techniques.
- Communicate clear vaccine recommendations and address questions from patients.
- Explain the vaccine safety, development and Emergency Use Authorization (EUA) mechanism.
- Describe characteristics of the vaccines used to prevent COVID-19 infection.
- Identify the storage and handling requirements for COVID-19 vaccines.
- Describe vaccine preparation, administration, documentation and reporting procedures for COVID-19 vaccines.
- Identify vaccination tools, checklists and other resources.
Additional COVID-19 resources and materials are provided from CDC to supplement these trainings as well.
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Do you want to know at any given time how many vaccines have been distributed and how many administered?
Do you want to find out if you are eligible for a COVID-19 vaccination and which Local Health Departments are scheduling vaccinations?
In addition to health care employees and staff and residents of long-term care facilities, older adults (ages 65+) and essential workers are now eligible to receive the vaccine, as supplies are available, according to the Michigan Department of Health and Human Services (MDHHS).
If supplies are unavailable through local health care providers, local health departments may be able to provide vaccines to some older adults and essential workers, although supplies are limited at this time. Individuals can check the website of their local health department to learn more about this option.
To identify the local health department and the services they may have available, visit Michigan.gov/COVIDvaccine and click How to Get a Vaccine. Individuals who do not have access to the internet can call 888-535-6136 and press option “5” for help finding information about vaccination in your area and to schedule an appointment, if available.
For all information on COVID-19 vaccines including FAQ’s, prioritization guidance, and more visit the vaccine home page here: COVID-19 Vaccine.
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Pharmacists Critical to Vaccination Efforts |
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MPA member Sarah Mahoney received both doses and had this to say:
"I trust science and genuinely care about other humans. I chose to be vaccinated because I trust in the process used to develop the COVID-19 vaccines. The science has been around for many years and now has a great place to be used.
"I chose to be vaccinated because I don’t want to risk passing along a potentially deadly virus. In October, I was exposed and was on a mild immunosuppressant at the time. That was enough for me to test positive, and I don’t want to have that fear of potentially passing on the virus again if I can help it. I was lucky to only have a very mild illness but fear brought me to tears more than once.
"I chose to be vaccinated because I miss sharing a theater space with my students. Anything that can bring us closer to experiencing theater again is worth the sore arm.
"My experience with the vaccine was a good one. My only side effects, both times, were a sore arm. Obviously each person will have to make their choice for their own reasons and these were mine."
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Share Your Photos With Us! |
In light of the critical role pharmacy professionals are playing in the nationwide vaccination efforts getting underway, the Michigan Pharmacists Association (MPA) would like to invite you to share your photos with us. Whether you are preparing, administering or receiving the vaccine, help us promote the safety and efficacy of vaccinations in ending this pandemic, and pharmacy professionals' role in doing it!
Share your photos with us on social media, or email communication@MichiganPharmacists.org. We would love to feature the incredible work you are doing on the frontlines. Thanks for your dedication and hard work as we enter what we hope will be the last phase of our battle with COVID-19. |
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