Information for Louisiana Pharmacies
Covid Vaccine Updates
Please Bookmark The LDH COVID 19 Vaccine Provider Updates Page
LDH has created a webpage for important provider updates and documents pertinent to COVID vaccines.
This reporting is in addition to the requirement that providers report all COVID-19 vaccination related adverse events/reactions to the Vaccine Adverse Event Reporting System (VAERS) managed by the CDC and FDA.
Be sure to sign up for LINKS immediately if you have not done so. All COVID vaccine administration requires LINKS to interface with the federal system.
LDH COVID Vaccine Ordering & Storage: Critical Updates
In their Thursday (7/29) COVID Vaccine Summary, LDH provided the following information regarding COVID vaccine ordering and storage:
It is critical that vaccination providers continue to plan ahead to help ensure vaccines are available well in-advance of when they are needed for administration to patients. The delivery of COVID-19 vaccinations, after order placement in LINKS, can take 3-5 business days. The Immunization Program is currently experiencing an influx of COVID-19 vaccine orders.
The minimum available Pfizer COVID-19 vaccine order for direct shipment from the manufacturer is now 450 doses. Previously, the direct minimum order of the Pfizer vaccine was 1,170 doses. The 450-dose Pfizer shipments are delivered ultra-cold and include three trays, with 25 vials of vaccine within each tray.
The extension of Johnson & Johnson vaccine shelf-life has been extended from 4.5 months to 6 months (+45 days). This expiration date change applies to all non-expired J&J vaccines currently in Louisiana. The LDH Immunization Program will automatically update the J&J expiration dates in LINKS to reflect this new extended expiration date so no additional provider action is required in LINKS.
COVID Testing Updates
We have seen an uptick in interest in COVID testing by our member pharmacies as focus is increasingly being placed on COVID testing—including not only for folks who suspect they could have the virus but also those who choose not to get the vaccine.
Ordering/performing COVID tests is something you may wish to consider if you are not already doing so.
Important things to know about COVID testing:
All Louisiana-licensed pharmacists have the authority to order and perform FDA-authorized COVID tests, per an April 15, 2020 Emergency Order from the State Health Officer. Special certification or training is not required. A collaborative agreement with a doctor is not needed to order and perform tests.
A CLIA Certificate of Waiver must first be obtained by the pharmacy, which “waives” the more stringent requirements for complex lab tests. LIPA’s updated information on obtaining a CLIA Certificate of Waiver—which costs $180 and is good for two years-- can be viewed here.
The FDA specifies which tests can be performed under a waiver, and COVID diagnostic testing is including.
To be reimbursed by Medicare or HRSA for the uninsured, you will need to be enrolled in Medicare Part B as a laboratory. You can enroll at no cost (if we were not in a public health emergency it would cost $595!) and enrollment is being expedited during the public health emergency). The enrollment will be good for five years.
COVID Provider Education & CEUs
PREVIOUS CE ACTIVITY DOCUMENTS & INFORMATION:
COVID Vaccine Administration for Louisiana Pharmacies
LIPA hosted a Zoom meeting on January 3rd to prepare members for the vaccine rollout.
Click Here to watch the video
Click Here for a PDF of the presentation
COVID-19 Vaccination CPE Activity:
LIPA hosted a one hour continuing education activity designed for pharmacists and pharmacy technicians interested in COVID-19 Vaccine Administration. Click Here to view a copy of the slides from this CE Activity.
COVID Vaccine Provider Updates
"Booster" 3rd Shot Information
Moderate to Severely Immunocompromised Persons: People can self-attest that they meet this criterion and one of the choices on the attestation form is “Other conditions which cause moderate or severe immunosuppression similar to the above conditions” which do not have to be specified. LDH’s “ask” of vaccine providers is that you print copies of the said form and have it available for patients to complete (check a box and sign/date). They add “widespread vaccination is a critical tool to help stop the pandemic.” Vaccine providers should retain a paper or electronic copy of completed and signed forms for a period of six months, after which they may be destroyed. Forms should be stored and destroyed in a HIPAA-compliant fashion. People who attest to moderate to severe immunosuppression can get a third (booster) dose as long as it has been 28 or more days since their second dose of one of the mRNA vaccines.
Everybody Else: Wednesday, the White House announced that third (booster) doses are recommended for everyone who has gotten the COVID mRNA (Pfizer or Moderna) vaccine, beginning eight months after their second dose. They should receive the same vaccine they originally got to the extent possible. Some pharmacies gave second doses as early as the first week of February, meaning the eight- month mark will be the first week in October. The good news is that you can anticipate being able to get all the vaccine you need to give third doses. While we know pharmacies administered primarily Moderna vaccine, you can expect to have patients who received Pfizer at hospitals or mass vaccine events, With Pfizer shelf life now 45 days (14 days in regular freezer and then 31 days in refrigerator), it is much more feasible to stock both of the mRNA vaccines than it was in January!
Vaccine Provider Enrollment Information
While we have nearly 250 independent pharmacies in Louisiana who have already enrolled as COVID Vaccine providers, we have many others that have not yet completed the enrollment process. It is not too late. LDH updated the process for enrolling Vaccine providers, with four important improvements that will reduce provider uncertainty as to whether the Immunization Program has received the completed Agreement and the status of their application:
LDH Enrollment Hotline: (855) 453-0774
A new e-mail address has been established exclusively for enrollment purposes: EnrollLA.LINKS@la.gov . This email will only be monitored for enrollment and no other purposes.
NEW A confirmation email will be sent within 24 hours after submission. Be sure to check your spam inbox.
If you do not receive this confirmation, your form has not been received [and you know to go ahead and e-mail it again]
Instructions and a list of frequent provider errors in completing the form are on Page 1 of the pdf rather than having to go to two separate documents for this information.
LIPA receives a list of all Ready to Receive and In Progress providers and can check your status if you are not certain whether you are enrolled. E-mail your inquiry to firstname.lastname@example.org
Common Provider Vaccine Questions
Click Here for this useful information page on the LDH website
Click Here for tips on minimizing audit liability for COVID vaccinations
Vaccinate Your Employee “Vaccinators” First
Louisiana Immunization Program Manager Stacy Hall advised that pharmacies receiving the vaccine should first administer it to their employee-vaccinators, but not all their employees, and then to patients.
Reminders for Pharmacies Receiving the Vaccine
Moderna vaccine should be immediately refrigerated upon receipt. Receipt of vaccine should be promptly entered in LINKS.
Pfizer vaccine Instructions for storage of Pfizer vaccine in the thermal shipping cooler (975 doses per container) can be found here. Receipt of vaccine should be promptly entered into links
Pharmacies with Approved Redistribution Agreements Accept all the vaccine in LINKS. When vaccine is transferred to another location that is Ready to Receive, update LINKS to show vaccine was transferred so that the receiving location can go in LINKS and add it to their inventory.
Fact Sheets for Recipients and Caregivers Vaccine fact sheets differ depending on whether it is Moderna or Pfizer.
Vaccine Expiration Dates: To determine the expiration date of COVID vaccine, scan the QR Code located on the vial or carton. The QR code will bring up a website; then choose the lookup option and enter the lot number. The expiration date will then be displayed. You may also access the LINKS Website directly or use the CDC Expiration Date Tracking Tool to help with documentation.
Priority Processing of Vaccine Provider Enrollments for Pharmacies
LDH has agreed to LIPA’s request for priority processing for independent pharmacies that submit provider applications. Roughly 145 independent pharmacies are “Ready to Receive” the vaccine. The applications for several members are: 1) In Progress; 2) Sent Corrections; or 3) Not Received. LDH hopes to complete all “In Progress” applications this week.
Email laLINKS.@la.gov to request confirmation that your enrollment information was received.
See this CDC Website for information about the Moderna vaccine, including how to store, handle, and administer it.
COVID Vaccine Reimbursement
Louisiana Medicaid published its COVID-19 Vaccine and Treatment Fee Schedule. It includes billing information.
CMS published a document for Medicare Vaccine Shot Payment Information.
LIPA published a document for Vaccine Administration Reimbursement for Uninsured Individuals.
COVID Vaccine Fact Sheet that Must be Made Available to Recipients
Here is the link to Moderna’s COVID vaccine website which is a good resource for information about the Moderna vaccine. You can use the “pink buttons” at the top to download the very latest version of the Fact Sheet for Recipients and Caregivers that must be made available to patients prior to giving them the Moderna vaccine. [There’s a different Fact Sheet for the Pfizer vaccine] It is six pages but you do not have to print copies and give to everyone. OPH suggested posting the pages on a wall, having several laminated copies or copies in sheet protectors (wiping them down after use) for folks to review, or providing the information electronically. The fact sheet contains a QR code that can be scanned to download the Fact Sheet information to a smart phone. Here is the link to the CDC’s webpage for Moderna vaccine.
Avoiding COVID Vaccine Spoilage
OPH has posted a new document on their COVID 19 Vaccine Information for Health Care Providers webpage with written guidance detailing steps that should be taken by providers to avoid spoilage of COVID vaccine. As a reminder, while Pfizer’s vaccine is more time sensitive and must be used within 120 hours after being removed from the ultra-cold shipping container (which happens before it leaves Morris and Dickson in Shreveport), Moderna vaccine can be stored in the refrigerator for up to 30 days prior to first use, after which the vial, which contains a total of ten doses, should be discarded after six hours, per this Moderna fact sheet.
Notably, if COVID-19 Vaccine Product is set to expire within six hours, OPH guidance stipulates the following sequence for getting the vaccine into an arm rather than allowing it to spoil:
· Identify and administer vaccine to persons that are eligible in Phase 1a;
· Administer vaccine to outpatient health personnel and health-related support personnel in the community;
· Administer vaccine to persons aged 70 years and older;
· Administer vaccine to other persons not identified above.
In the event that the vaccine does expire--despite your best efforts to avoid vaccine loss--the loss should be reported to the Immunization Consultant for your region. Contact information for your region’s Immunization Consultant can be found on the LINKS home page. LDH’s Immunization Program leadership states their intent is not to take punitive action but to assess what if any steps can be taken to reduce vaccine loss going forward.
PREP Act Permits Pharmacy Techs To Administer COVID Vaccine
Provided they meet certain conditions and receive the required training, Louisiana pharmacy technicians are allowed under the PREP Act to administer the COVID 19 vaccine and COVID tests as well as vaccines to children ages 3 and older. During the current public health emergency, the federal law allowing this supersedes any more restrictive state regulations by the Louisiana Board of Pharmacy.
In anticipation of the availability of the COVID vaccine to LIPA member pharmacies in early 2021, now is the time to get pharmacy technicians on board and “qualified” to administer the COVID vaccine as soon as it becomes available to you. Here are three prerequisites to “qualify” that we want to call to your attention since they take some planning [the complete list can be found here]
Complete a practical training program that is approved by ACPE. This training program must include a hands-on injection technique and the recognition and treatment of emergency reactions to vaccines.
Have a current certificate in basic CPR.
Have completed a minimum of two hours of ACPE-approved, immunization-related CPE during the current State licensing period(s).
COVID-19 Provider Document Links & Updates
LDH issued Health Alert Network Memo # 66-21 that included the following instructions for post-storm vaccine wastage:
"If you have lost/wasted vaccine (COVID-19 or VFC) due to Hurricane Ida, please fill out the vaccine loss report and send to you Regional Immunization Consultant by email. Regional Consultant contact information (including email) is located on the bottom of the LINKS homepage. Please discard of all lost/wasted vaccines in the same manner you do your other biologicals."
If you intend to be a COVID vaccine provider, have you completed all of the necessary paperwork? Should you need to access Louisiana COVID 19 Vaccine forms, you can use the links below:
CDC COVID-19 Vaccination Program Provider Agreement - 11/2020
CDC Supplemental COVID-19 Vaccine Redistribution Agreement - 10/2020
COVID-19 Provider Agreement FQA’s
Provider Enrollment Common Mistakes
LDH COVID-19 Vaccine Provider Webpage