State-by-state COVID-19 Vaccination Rollout Guide Helps Pharmacies Navigate States’ Vaccination Efforts
Pharmacy Times® interviewed Lee Rosebush, JD, PharmD, MS, MBA, partner at Baker & Hostetler, on an interactive state-by-state vaccination rollout guide his law firm created to help pharmacies and providers navigate the various state approaches to coronavirus disease 2019 (COVID-19) vaccination efforts.
Alana Hippensteele: So Lee, what is the guide that Baker & Hostetler created, and how can it help pharmacists and pharmacies navigate state guidances around COVID-19 vaccination?
Lee Rosebush: Sure, thanks for having me. In essence, it's a free resource that we actually host on our website and it comes down to a breakdown of each of the state plans and what pharmacies and those in the pharmacy industry can look forward to as to an understanding of where things are heading with the vaccination program. One of the things that we often get is questions from pharmacies and pharmacists saying ‘What can we do, and what can't we do, and who's eligible to receive this,’ and we tried to break it down into an easy resource for those in the industry.
Alana Hippensteele: Right, and where can pharmacists find this guide, and how can they expect to be able to use the information in practice?
Lee Rosebush: We actually have a website bakerlaw.com, and on that website we actually have a resource strictly for COVID-19, and underneath that we have a pharmacy reimbursement team that also has some pharmacy resources, things along the lines of reimbursement aspects, pharmacy doctrine, state law aspects, and one of those is this web page. Actually we tried to make it as interactive as possible for pharmacists who wanted to go in and click on their individual states, or for individuals who are licensed in multiple states from pharmacy to multiple states like myself. You actually could go in and click on different states to see where the plans have changed.
Alana Hippensteele: Right. What are some of the ways that state guidance around COVID-19 vaccination can change state-by-state?
Lee Rosebush: It's interesting, it's one of the things that we're seeing rapidly change. Honestly, there's a couple of areas that we often point to and get questions to on the pharmacy program. Just being who's eligible, I mean honestly we've heard multiple times is it those who are elderly, is it those who are healthcare workers, or is it those who are teachers, and so one of the things that we often point to for those in the pharmacy industry is to take a look at the prioritization schedules. We often get the question, is it the Biden administration, is it HHS who controls that, and HHS and CDC really puts forward recommendations—it really is controlled by the state. So, to understand who's eligible and who's up next, you really do need to keep track of that plan.
The other thing that we often get too is who can actually give the vaccination. So there have been questions, for example, on in our industry, pharmacy interns, pharmacy clerks, those who have graduated but don't have laws on licenses yet, technicians, and we've tried to narrow it down just for a resource again for those in the pharmacy industry to say who can actually give the shot.
Alana Hippensteele: Right, and what are some of the unique regulatory and compliance issues facing pharmacies under the emergency use authorization?
Lee Rosebush: The interesting thing is this is an authorization that means it's not FDA-approved. And let's be honest, COVID in the emergency authorization will likely be around for a while next year that doesn’t mean it's not FDA-approved if the emergency authorization goes away, that means it's no longer eligible to be given. And so, one of the things that we're monitoring is where's FDA on the actual quote-unquote approval of this because, hopefully, as things move forward, they actually obtain the FDA approval.
The other thing that's interesting for those in the pharmacy space is what does that mean for payment. Obviously, we've all dealt with things like [drug efficacy study implementation] drugs and compounding, and those that are unapproved, and this is technically unapproved. So, what does that mean: As we move forward, for those who are trying to get reimbursement for these shots.
And then the last obviously is the PR that goes around this. We've all heard of those who have traveled to other areas, or for lack of a better term, lied on the applications to get the vaccine to say that they're eligible when they're not, and there are obviously some PR ramifications, and some things along those lines that we need to be aware of as we move forward.
So again, we've tried to provide those types of resources on the website so individuals who, as they move forward, have some other areas of concerns they might be able to point to and things they need to keep in the back of their mind.
Alana Hippensteele: How might these regulatory and compliance issues affect administration, costs, and record keeping?
Lee Rosebush: The big one is—you hit the nail on the head at the end—the record keeping. You know, one of our biggest concerns obviously in the pharmacy space is compliance. So there's a question of: Do we give it 2 weeks out, do we give it 3 weeks out, do we give it 4 weeks out. You have to keep track of who had Pfizer versus the Moderna vaccination, for example, and what that means as to moving forward. So, we have an awful lot of questions that we get on the pharmacy industry side of ‘What does this mean for record keeping, how do we report it, and when do we report it.’
Another thing that those in the pharmacy space really need to make sure they monitor is if you look at the CDC plan, the HHS plan, the discussion was around a 24- to a 72-hour time period as to when you have to report it. So, if I walk in to get the shot today, it's supposed to be reported within 3 days. Well not every state follows that, and if you've got a broad spectrum IT program that keeps track of all your reporting for you, is it honestly following the proper state plan that 24 hours or 48 hours as compared to the federal 72 hours? Again, areas that you need to keep into consideration.
Again, I'm not pointing fingers at any specific state, but I'll give you a perfect example: If you look at Governor Cuomo's early statements in the state of New York, there was a threat of potentially jail time if you actually administered a vaccine to those who were ineligible, and if you didn't follow the plan on the reporting program, you wouldn't receive additional vaccine moving forward. They would, in other words, cut how much you received. So, these are real life concerns, especially for those who are wanting to move forward to want to administer, to make sure it's done to the right individuals, and that you are properly reporting as required.
Alana Hippensteele: Right. Is there anything else pharmacies should consider as they prepare for or continue to provide COVID-19 vaccinations?
Lee Rosebush: It's a big one. Obviously, as we move forward, independent pharmacies, I think, have a great opportunity here to be able to show their need and the ability that they can respond in these types of emergencies. A great example—we just talked about New York—is West Virginia. In this situation, if you look at what the governor of West Virginia has stated in the ability to vaccinate basically every resident in a long-term care facility using independent pharmacies, it shows higher need for any ability for those in the pharmacies to move forward, and the access they can have, and the impact they can have. So, as we as a pharmacy industry move forward in this, I think it's really, really important that we continue to show just how much of an impact we can have for this pandemic.
Alana Hippensteele: Right, right. Do you have any closing thoughts?
Lee Rosebush: I would applaud all of our health care workers. Obviously, it's been a hectic last year, a hard last year, and they continuously push of masks, push for vaccines, and they continuously emphasize treating this, as it is as a pandemic. We as a pharmacy industry have come a long way, and I would continue to applaud those who continue to push forward in this industry.
Alana Hippensteele: Thank you so much for taking the time to speak with me today, Lee. Now let’s hear from some of our other MJH Life Sciences brands on their latest headlines.