Episode 22: Partnering with the Federal Government to Fight COVID-19 with Laura Kemper and Nate Elias
Laura Kemper, Head of Federal Government Affairs, and Nate Elias, Head of U.S. State Government Affairs, join Field Notes to give a behind-the-scenes look at the efforts to forge a one-of-a-kind partnership with the federal government to procure and distribute the Pfizer-BioNTech COVID-19 vaccine to dialysis centers across the country.

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Brad Puffer: Welcome, everyone, to this episode of Field Notes. I'm Brad Puffer, on the Medical Office Communications Team at Fresenius Medical Care North America, and your host for this discussion today. Here, we interview the experts, researchers, physicians, and caregivers who bring experience, compassion, and insight into the work we do every day. 

As we all know, a successful rollout of the COVID-19 vaccines is critical to our ability to end the pandemic in the United States, and also, to protect our patients with kidney failure who are at high risk of complications from the virus. Initially, many dialysis patients found it difficult to get access to the vaccine on their own. Our company has long understood that direct allocation of vaccines to our patients in our dialysis centers was essential. 

It was both a state by state, and then federal advocacy effort that eventually led to a national agreement and rapid vaccination of thousands of patients in often under-served communities. We're grateful to be joined today by Laura Kemper, Head of Federal Government Affairs, and Nate Elias, Head of State Government Affairs. Both Laura and Nate helped lead efforts to educate and inform policymakers about the risk of COVID to our patients, and our ability to help the most vulnerable get access to the vaccine. Laura and Nate, welcome to Field Notes. 

Laura Kemper: Thanks so much, Brad. 

Nate Elias: Thanks for having us. 

Brad Puffer: Perhaps, we can start with you, Laura. Why was direct allocation to vaccine so important for us, and why were we in such a great position to have a successful rollout? 

Laura Kemper: Early on, we really knew the disproportionate impact that COVID was having on patients with ESRD. And also, how important it was to ensure our patients and front-line health workers were vaccinated. I think because we're such a large company with a national footprint, it really made sense to pursue a federal allocation, so that we didn't have to try and navigate the state by state. 

We felt that we could deliver for the federal government by helping to quickly vaccinate a large population of vulnerable patients, and frontline workers. But really, our strategy was always to pursue this dual track, so state and federal in an effort to leave no stone unturned. And in terms of our positioning for a successful rollout, we've had such high success rates I think with other vaccine administration in the past, such as with seasonal flu vaccine, it really seemed natural that our patients and workers should receive the vaccine from us. 

And given that we see our patients so often, we were ideally suited to handle this with minimal effort from the federal government. And really, the only thing that was missing was the vaccine allocation. I think the other important point was with Pfizer and Moderna vaccines that require two doses, we were able to ensure uptake of the second dose, since we see our patients so often. And this assurance I think was something that the pharmacies and the other sites of administration couldn't offer. 

Brad Puffer: Turning to you, Nate, it seems like our patients getting the vaccine was really the biggest priority for Fresenius Medical Care North America for a while. Was the mandate loud and clear from the top down? 

Nate Elias: Yeah, absolutely. Throughout the pandemic, even before the vaccines were available, much of the decision making authority around treatment protocols, PPE requirements, medical transportation, you name the issue, were really ceded to the states and the territories. So some of the states pushed some of those decision making authorities even further down to the counties. So throughout the course of the pandemic, for a year plus, we've been dealing with the state by state dynamic. 

When the vaccines came out, it was very clear that it was once again, going to be a state by state process until we were able to get a national vaccination program with the CDC. So there was no doubt that this became priority number one once the vaccines became available, is to do everything that we could within our power to make sure that our front-line health care workers and our patients got access to the vaccines as quickly as possible. 

Brad Puffer: And Laura, how soon did that planning and advocacy begin talking to policymakers, for example. Were they receptive to our concerns about patients with kidney failure, and getting access to this vaccine as soon as possible? 

Laura Kemper: We actually started our advocacy before even the first dose of vaccine was officially administered in the United States, which was about mid-December. We first approached Vice President Pence's Chief of Staff in early December explaining our capabilities as a company to be able to execute on a national vaccine allocation for the entire community of kidney patients. And we were lucky that actually, the very same day we met with Pence's Chief of Staff, Seema Verma, who was then the Head of the Centers for Medicare and Medicaid Services, she actually held a call that evening with dialysis providers where she agreed about the importance of vaccinating our patient population, I think, because they were seeing the same data that we were and she agreed in one of the meetings with the governors to explain the impact that COVID was having on our patients, and try to encourage them, as Nate mentioned, on the state level to consider moving our patients higher up on the list. Apart from those meetings, we also got connected with the CDC directly on December 17, and started a number of conversations related to our capabilities to vaccinate patients in our centers. I think that was something that we had to overcome in helping to educate people about why our patient population was so vulnerable to COVID, and needed to be addressed at the same time as these other patient populations. 

Brad Puffer: Well, as you mentioned Laura, it seems we recognize that back in December, this really was going to be at least for a while a state by state effort. And so I want to ask you, Nate, what it was like when you first heard that we would have two vaccines with use authorization in December and January, and how hard was it to get the attention of the state health departments to get allocation of this vaccine for both our employees and then patients. 

Nate Elias: There frankly, was a lot of confusion and ambiguity amongst the states. And I think they were the first to make recognition of this as we did outreach to the states. If you'll recall, there were issues with the manufacturing and distribution process. And pretty much every state in the nation was saying that they weren't getting enough vaccine to treat front-line health care workers. And just the entire logistics process of how the states ordered the vaccines, how they received it, how they distributed internally, - bit of a learn as you go process for the states as well. 

So again, recall very early on the priority and the mandate from the federal government to the states was, get front line health care workers vaccinated. But it was a very hospital focused effort at first, and the vaccines were flowing straight to hospitals. So if you were not a hospital based health care provider, it did at the beginning put you in a little bit of a strange position as to how you got your front line health care workers vaccinated. 

So our outreach was, we have a built in infrastructure, and access to our patients more than any other setting in health care. We have experience with vaccination, and we can very quickly, and safely, and efficiently vaccinate all of our staff, all of our patients. And you can sort of cross us off your list. 

And the response we got in the very beginning was, A, we don't have enough vaccine to even do our front-line health care workers right now, let alone patients. And B, we don't have enough vaccine to just give you your own allotment. So for the time being, you're going to have to work within the system that's has been set up. So it was a little slow going at first, but it was for everybody, because there was a lot of just learning as you go with state governments, local county health departments, and the federal government. 

Brad Puffer: And I know you couldn't do that all alone. So it's really impressive to think about how we did that advocacy in 50 different states. And my understanding is you identified essentially a state champion in every state who could try to navigate with the local health departments. Is that correct? 

Nate Elias: The state champions program was really the brainchild of our clinical operations team. And the dynamic we were seeing was really twofold. Number one, this did become a very local, very granular process in a lot of different areas where the state further pushed things down to county health department, and sometimes, even down to just very local hospital systems to administer the vaccine and make decisions about who could and couldn't get them. 

So we realized that our quickest path at the beginning was through some very local contacts. Our clinics all over the country already had existing relationships with their local county health departments for various reasons. The other thing that we needed to ensure was that every single one of our clinics was registered with whatever state immunization registry, or reporting registry, that that state required for us to be a vaccine administrator. 

So we did go to basically, a 50 state by state champion team, where every state had a senior level clinical manager operations person that was that state's vaccine champion. It was their responsibility to make sure all that local outreach was going on from the clinic level to the county health department, and then also making sure that every clinic in that state had the proper registrations on file with the state, so that when we did have an opportunity to get the vaccine, we were ready to go, and there wasn't any delays in accepting vaccine and providing vaccines. 

Brad Puffer: And Nate, I know eventually, we did have some breakthroughs and success statewide. States like Louisiana led the way, and Massachusetts and Minnesota. How successful were those early state wins? And did they help convince other states to come along? 

Nate Elias: Yeah, absolutely. So we have to give a big shout out to Louisiana. Louisiana was the first early adapter to the model. I recall being on a call with the chief health officer, the state of Louisiana, and Mike Asselta, the President of Fresenius Kidney Care, and we laid out the opportunity that we provided, again, with the infrastructure that we had built into place, the frequency at which we saw our patients, highly trained staff that had experience with vaccines, and this physician, the chief health officer in Louisiana, he got it. 

He and his team, they got it. And they said yes. We see the opportunity here. Let's do it. So they provided us a direct distribution of the vaccine for any remaining staff that hadn't yet been vaccinated, and our entire patient population who wanted the vaccine, and who were accepting the vaccine. And within the matter of a few weeks, we very safely and efficiently with basically zero wastage of any doses, vaccinated everybody in the state of Louisiana in our system that wanted the vaccine. 

And it really bore a lot of fruit down the line. And as you said, we started getting state by state here and there, other states recognizing the opportunity that this type of system bore out. 

Brad Puffer: Well, Laura, as Nate was in the trenches getting momentum with other states coming along for federal allocation, there were still a lot of states that weren't providing direct allocation yet. As you were talking to the federal agencies in the White House, it suddenly changed with a new administration and inauguration. Did you feel like you had to start over in some respects? 

Laura Kemper: Really, the good thing is, is that actually the majority of government functions with long term career officials who have been there for years, and who don't change when the administration changes. So we were really lucky in that everybody that we had been meeting with at CDC from those earliest meetings in mid-December, they were still there once President Biden took office. 

I think the issue for us certainly was that at the highest levels of the White House, there were newly installed political officials, especially with the White House COVID task force. So we definitely had to spend time educating them about our patient population, and the importance of a potential federal allocation to us. We did feel that the transition actually offered us a bit of an opportunity, because it presented I think, a shift in thinking. 

The Biden administration we felt was going to be more interested in potentially using federal programs as a means to reach broader populations, and target those most at risk So the transition opened the door for us we felt to make a renewed push for the importance of a federal allocation. 

Brad Puffer: And how big a factor was the administration's focus, for example, on health equity on their decision to ultimately give us a federal allocation? 

Laura Kemper: We did spend a lot of time early on meeting with some of the new staff at the White House helping them understand who our patient population is. And that was really key, I think, for them. Because when they came in, and inherited this program of vaccine distribution, I think there was some criticism that minorities who were being disproportionately impacted by COVID, were also being vaccinated at a slower rate. 

So we really spent a lot of time trying to help them understand who our patient population is, even the makeup of our 1A front-line health workers, and that was definitely key, I think, to helping us move across the finish line with getting a federal allocation. 

Brad Puffer: Nate, so how important was that federal allocation then for the state by state efforts. Because some of our states are now up to 60% or 70% of patients vaccinated, while other states, we're still only around 15%. This national rollout must have been hugely important to level the playing field. 

Nate Elias: As much as we try to educate everybody around the country, there are still some people that just weren't quite understanding, for example, some of the challenges that our patients sometimes have with transportation. And we get responses back from the states saying, well, most of your patients should be eligible by now, because of our age based protocols for vaccines. And we have mobile drive-through vaccine sites set up all over the state, so they can just hop in their car and drive-through, and get a vaccine. 

Well, in a lot of cases with our patient population, it doesn't work. And that's why we were pushing so hard to be able to get the vaccine directly into our clinics, so that we could vaccinate our patients while they were in receiving their dialysis. So we were continuing to push on this extremely hard on a state by state basis. 

But when the federal allocation was finally approved, it was a great relief to everybody, because we knew that at that point, that we didn't have to deal with these differentials in protocols for the vaccine state by state, and we could just get everybody vaccinated. And it was just a huge sigh of relief for everybody. 

Brad Puffer: And Laura, take us to that week. I mean, that must have been a huge week when we learned that we would actually get a direct allocation. What was the emotion behind that for you, and how quickly did we have to jump into action to really capitalize on this opportunity? 

Laura Kemper: It was honestly, a relief I think for all of us who had been working on this since mid-December. 

We felt that we had the experience. We knew how to execute this. So it was just a relief that they had finally seen the value that we could bring in hoping to vaccinate our patients. Because we just kept having to keep up the drumbeat explaining why our patients weren't able to access those sites. Nate mentioned transportation. We also have some digital literacy issues. And frankly, early on, patients were lining up in long queues at these federal sites to be able to receive vaccines. And that's just something that our patients aren't able to do. So what we really learned through all of this, and helped to educate the White House on, is that our patients view us as their primary care provider. And they ultimately expect to receive their vaccines from us. So it felt like a real win for the entire team to be able to actually finally deliver on something that we had been working on for so long.

Brad Puffer: Laura, how important was it that we cooperated so much with smaller providers as well. I know a lot of efforts have gone into training, educating, and distributing to smaller providers, because this was not just Fresenius Medical Care North America issue. This was an industry issue for all dialysis patients. 

Laura Kemper: Bill Valle, the Head of Fresenius Medical Care North America always said in every meeting that this was about the nationwide community of dialysis patients, and all of our front-line workers. So pretty early on into it, we realized that it really needed to be broader than just the providers. So along the way, and I hesitate to call people out, because there were so many involved, but for instance, the American Kidney Fund, the American Society of Nephrology, and some of the patient groups were involved. And we approached CDC and the White House with a solution for the entire industry. 

And basically, we presented ourselves as willing to play whatever role that we needed to ensure that the entirety of the ESRD community, and workers were vaccinated. We also really spent a lot of time talking with members of Congress about this, who did get involved, and help to weigh in with the White House. We even had a few members ask questions about a dialysis federal allocation during a public hearing with the CDC director, all in an effort to just continue the drumbeat. 

It took a lot of meetings amongst the community. But I think the eventual unanimity of the industry, and in agreeing that this federal allocation was really important, and a key to solving this disproportionate impact COVID was having on the patient population, that was key to our ultimate success in this. 

Brad Puffer: And Nate, how has it been going so far? How is it state by state now? Are we seeing that playing field being leveled? And how successful has the rollout been within our centers? 

Nate Elias: Nationally, we have just really fantastic vaccination rates, both with the states had provided this vaccine already, and then layering on the federal allocation on top of that, I think we're really starting to get to a critical mass of vaccinated patients. And we've been working very well with the states on the vaccination program now, turning some vaccine that we've gotten from some states back to them, talking now about how are we going to get small batches of doses of the vaccine to some remote clinics. 

And really, and I think you've heard it loud and clear from our medical office, from Bill Valle, our CEO, and everybody else, I think probably just one of the biggest issues that we're facing right now is just vaccine hesitancy, and we're just encouraging everybody who can get the vaccine to get the vaccine. We now have access to the vaccine for all of our patients, all of our staff. And we want to make sure that everybody who's willing to get the vaccine is utilizing it. 

Brad Puffer: Patients certainly trust our nurses, and our providers, and their advice, as well as their nephrologist. So everybody working together to make sure that we overcome any vaccine hesitancy that might be lingering out there. Laura, any final words from you on seeing this finally come to fruition and this be successful with patients, and our staff getting the vaccine they need. 

Laura Kemper: I was just so impressed. You know, even every time we were faced with a challenge, people just said, yes, and then I think went off to figure out how to make it happen. So everybody had a very positive attitude, and were willing to pull together to make sure that we were able to make this a reality for our patients. 

Brad Puffer: Well, Laura and Nate, this has been a great discussion. Thank you both for joining us, and giving a little behind the scenes look at our work to get our patients vaccinated as soon as possible, and to help end the pandemic. Thank you. 

Laura Kemper: Thanks so much. 

Nate Elias: Pleasure being here. 

Brad Puffer: And to our audience, thank you for joining us. Please know that your feedback is always welcome. If you have comments on today's episode, topics of interest to you, or speakers you want to hear from, let us know by clicking the feedback link featured on the Field Notes website on FMCNA.com. Don't forget, you can find Field Notes on the Apple Store, or Google Podcasts, or right here at FMCNA.com, where you can also find our annual medical report, and other featured articles. We hope you'll come back and join us. We have many more topics to discuss in the weeks ahead. Until next time, I'm Brad Puffer. You've been listening to Field Notes by Fresenius Medical Care. Take care everyone.