Outcomes Rocket Podcast_Chip Moebus: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Saul Marquez:
Hey everybody! Saul Marquez with the Outcomes Rocket. I want to welcome you back to this incredible series we’re doing on chronic low back pain solutions and new ways of thinking about how to address this very common problem in our country. Today I’m privileged to have Chip Moebus on the podcast. He is the Vice President of Reimbursement and Market Access for Mainstay Medical. Chip has been in the healthcare industry for 23 years, serving in multiple roles ranging from field sales leadership to leading teams focused on managed markets and health economics at Medtronic, Senseonics, and Mainstay Medical. Currently, he’s focused on driving coverage with Medicare and commercial insurers for a novel Neuromodulation device for the medical management of chronic low back pain called ReActiv8. If you’ve been tuning in to our series, you’ve been steeped into it, but if you haven’t, make sure you check the show notes of today’s podcast for all the previous episodes we’ve done on this amazing therapy. Previous to Mainstay Medical, Chip has led the development of LCDs and national payment for Category Three CPT Code, as well as driving commercial insurer coverage for implantable devices. With that introduction, I want to welcome you to the podcast, Chip, so glad that you could join us today.
Chip Moebus:
Hey, thanks Saul, I appreciate you having me on today.
Saul Marquez:
Absolutely, and so today what we’re going to do, folks, is give a landscape overview. Chip, Chip’s been doing this for quite some time now, and we want to better understand what is the landscape of chronic low back pain. What are some of the existing treatments? What are some of the opportunities we have, the challenges currently faced by clinicians and patients? So Chip, help us understand what challenges are existing today with bringing innovation forward and chronic low back pain.
Chip Moebus:
Yeah, thanks, Saul. I’ll focus more on the reimbursement elements as it relates to bringing innovation forward. That’s one of the bigger challenges when you’re trying to drive a new solution into a very complicated and complex disease state like chronic low back pain. I guess I’ll start with payers and their understanding of chronic low back pain as a disease. Payers in general have a reasonably good idea of the different types of chronic low back pain that are out there. And this is born out of a lot of the policy development that they’ve done to support earlier treatment options in chronic low back pain that can range from anywhere relating to physical therapy, medication management, creating policy that supports certain surgical interventions, or even spinal cord stimulation. And the payers are fairly adept at understanding the treatments that are available for chronic low back pain. But in terms of getting new information into this audience, that can be a little bit of a challenge because there is so much out there to be absorbed, and getting the message out there into the payer community really requires a lot of groundwork with our clinicians in the marketplace, it requires a lot of publication of data and clinical evidence, and it requires a team approach where folks like myself and my colleagues can go and meet directly with the payer community, including their medical directors, to educate them not only on the ecosystem of chronic low back pain in terms of an array of therapies, but also what is it specifically that we’re bringing to the table that fits into our current continuum, and then how is it going to potentially disrupt their current landscape. So we have our work cut out for payers. This is a challenging space and that’s really because there’s a lot of treatments out there. It’s a disease with a lot of different manifestations to it, and frankly, payers are wanting to ensure that if a treatment is going to be brought forward, that it’s durable and lasting, it’s efficacious and it’s meaningful to the patient, and it’s something that can actually take root in the marketplace and be considered a standard of care somewhere down the line in the future. So those are the things we’re really focused on here at Mainstay Medical in terms of creating that awareness with the payer community and meeting some of their needs.
Saul Marquez:
Yeah, thank you for that, Chip. And one of the things that comes up is, you know, new treatment modalities and an environment where, you know, payer community is working to not introduce as many new things. Can you share with us what could be done to help the payer community get more comfortable with bringing access to innovation like this?
Chip Moebus:
Yeah, sure, so it will always start with evidence, and they look to evidence as the first stake, if you will, in any type of consideration of adoption. And the evidence has to be robust, it has to have good scientific rigor behind it, such that folks within the insurance plan are comfortable expanding access to actually, in some cases, millions of patients. So it always starts with good evidence to support what it is that you’re trying to do in terms of an intervention, particularly in chronic low back pain. But you also have to be very clear about who are the patients that you’re targeting. Is this the right therapy at the right time in their continuum of care? And is that clinical benefit going to be derived consistently? So those are a lot of the things that Mainstay Medical and my colleagues here have been focused on, is evidence generation and patient selection criteria so that the payers do understand, hey, this does work for this group of patients. I can craft and create medical policy that creates clear lines on the road for who is an appropriate candidate for therapy, like ReActiv8, or perhaps who might not be an appropriate candidate for therapy. And through that work, you ultimately get to an understanding of economic value. I would say that’s the third pillar that the insurance industry is going to look for, is, Okay, you’ve proven to me that you work, you’ve proven to me that you’re safe, and you’ve proven to me that you can find the right patients and identify them for this treatment. But then what are the trade-offs that are going to occur by enacting this therapy? And those types of things are say, well, if I’m no longer using injections to palliate this patient’s pain, because we’re going to use restorative neurostimulation to resolve the underlying cause, immediately, the payer assumes, Okay, what are the economic trade-offs over a period of time that tell me investing in this is going to return some form of economic value back to my stakeholder, which is often an employer group, a patient, or a government. And those are important pieces of healthcare today, as we know, economic value is part of the decision-making process. I will say it’s not the sole determinant, but it is one of the larger determinants in whether or not a health plan chooses to go forward and open up broad access to a new therapy like ReActiv8. And again, that’s where a lot of our work is being directed to here at Mainstay Medical, is to already establish efficacy and safety in patient selection, but now how do we drive those economic understandings.
Saul Marquez:
Yeah, thank you for that, Chip, and I had a chance to talk to one of the physicians and even one of your patients that received the therapy. And I’ve got to tell you, I was like, I mean, I just got goosebumps. I was touched by the story and it’s just like the positive impact that a technology like this could have is really impressive, and really the onus is sort of on the frameworks that you shared. Now, like talk to us about ReActiv8, like how does ReActiv8 fit into all of this?
Chip Moebus:
Yeah, so that educational path is critical, right? Patients should be well selected and identified and we’ve got a great approach to establishing that understanding and then helping not only patients but clinicians and others understand some of these underlying causes of chronic low back pain that we now understand. Historically, perhaps we didn’t have a deep understanding, is partly because we didn’t have a solution for it, but maybe at one point or another, the audience that we’re now engaging didn’t have a reason to go looking for this understanding. So those are the first pieces that we have to create not only with patients and clinicians but also, as I mentioned earlier, the payer community. Then, in terms of the diagnostic pathway, what has to have happened first before you could get to something like ReActiv8, that too has to be well understood. This therapy, while it has wonderful outcomes associated with it, and you heard Dr. Gilligan talk about it, ideally we want to ensure patients have exhausted all of the conservative treatment measures that would include physical therapy sessions and good quality physical therapy. Have they used different medications to ensure that perhaps they are not able to resolve their pains purely with medications? And then maybe patients respond to some other type of minor interventions. If those can actually resolve the underlying issues or the pain that they’re, the patient is suffering from, then by all means, those are the first therapies to be engaged in terms of an algorithmic approach to how you get to ReActiv8. And frankly, that’s how the payer community will see it. They want to see that the lower cost, lower risk interventions have been tried first before you step into something that is slightly more invasive and that this is an active implantable device, it’s sort of like a pacemaker with a couple of leads that are percutaneously placed in a fairly straightforward procedure performed in an outpatient department or an ambulatory surgical center, but we have to show that these patients have exhausted all of their conservative treatment options first. And that’s, again, part of our education path, not only working with patients and our clinicians but also getting insurers comfortable with the idea of ReActiv8 being a treatment solution.
Saul Marquez:
Well, thank you, Chip. And you know, this solution is very unique, you know, and it’s, because it’s, it restores, right? So do you want to, just for the folks that haven’t had a chance to listen to the previous interviews, what exactly it does?
Chip Moebus:
Yeah, sure, so this is a 14-year journey for this organization in terms of understanding the details of chronic low back pain and some of the underlying contributors to mechanical or axial chronic low back pain. So first, we need to talk about what kind of back pain are we focused on. We are focused on back pain that does not have some type of neuropathic component to it, meaning there’s not some neural structure that’s being clearly imposed upon by another structure that creates a pain generator, right? Some of those treatments have either surgical indications or perhaps a spinal cord stimulator might be appropriate for some of those patients. This is not the cohort of patients we think ReActiv8 is most fit for. We are looking that those patients that have this artherogenic inhibition of their multifidus, which is the primary stabilizer of the lumbar spine. And fundamentally, what this therapy is designed to do is reestablish the neuromuscular control of the lumbar spine or, excuse me, the multifidus muscle, which again stabilizes the lumbar spine. So, in essence, once we place those electrodes strategically by a medial branch of the dorsal nerve, which innervates the multifidus, we can then start to reawaken those muscles, if you will, and the brain will then know to recruit those muscles for better stabilization of the spine. What the data shows us is after a progressive period of time, we do start to see a reduction in pain and improvement in function, and an improvement of overall healthcare-related quality of life. And we’ve now demonstrated the durability of this treatment up to three years from our pivotal study that we started several years ago. So it’s an exciting time in terms of identifying how this therapy actually works, who the patients are that can benefit, and then seeing a progressive, consistent improvement in pain over time that appears to be durable and lasting for our patients.
Saul Marquez:
Thank you, Chip. I appreciate the succinct summary of what it does. And you know, the one thing that blew my mind was that 71% percent of patients that were using opioids didn’t have to use it anymore. Like that’s just mind-blowing to me.
Chip Moebus:
Yeah, so that’s an important observation in our clinical work. Many of these patients just don’t have good treatment options. And many times, unfortunately, they’re going to have to resort to some pretty, pretty strong narcotics and/or opioids that are required to manage pain. That is really a result of just not having a good treatment solution that fixes the underlying cause of pain. And that’s what frankly gets us excited, gets us out of bed every day, is we know that there are patients out there that need a solution. They don’t have to resort to therapies that require continual revisiting of their physician, does not require the use of opioids and heavier drugs that confound a lot of other issues in our lives. Moreover, our clinicians are desperate for treatment options that allow them to put their prescription pad away. There is not a clinician out there that is excited about having to use opioids to palliate pain. It is purely as a measure of last resort. Now that we bring forward something that is proven to reduce opioid utilization, whether it’s the dosing or the actual cessation of use is exciting, but it’s really about fixing the underlying cause of mechanical, chronic, low back pain for this small cohort of patients that have lost neuromuscular control of the multifidus is really what gets us excited to get into the marketplace and help people better understand, all the way from the doctors to the patients. And for my role, it’s about educating the insurance industry about what this really means in terms of opportunity.
Saul Marquez:
Yeah, no, that’s fantastic, Chip. And I’m glad that you’re doing this work because it’s certainly work that requires attention to detail and it requires a view of both clinical and economic impacts. And when I think of, before COVID was even a thing, the opioid pandemic was real and it still is real. It’s gotten worse, and so it’s exciting to hear that this solution can be an answer to something that a lot of Americans struggle with today, and so thank you for that. You know, the benefits are obviously there. You know, give us a summary here. You know, what should we be looking forward to in the coming months and even years with this technology?
Chip Moebus:
As we continue to make progress in commercializing ReActiv8 in the US market, what we’ll find is that increasing payer adoption and coverage will ensue. It’s our obligation not only to the clinical trial investigators and the patients that can benefit from this therapy to open up that coverage door, which is so challenging in this market. So we know that the payer community will have to ultimately observe the data we have published and have to start to make some changes to certain coverage policies, and no longer will they be able to hold the door shut on innovation that’s well supported by the clinical evidence that you heard Dr. Gilligan talk about, but we know there’s challenges for the payer community right there. They’ve seen historical treatments come and go. That’s one challenge, right? That kind of creates some barriers. Also, there’s a whole new array of treatments that are coming to them that come in the form of other minimally invasive types of options. And I think really what the payer struggles with is, well, who are the right patients for which therapy and how do I know who to go create policy for? We have to be engaged with that payer committee. We have to help them understand who exactly we’re talking about, who generates the most benefit, and how do we ensure that there is a responsible focus on driving net health outcomes in terms of improving people’s lives with these types of therapies. So it is incumbent on us as Mainstay Medical to go lead in that space and drive payer coverage and payer acceptance and understanding. So I think that’s something that we can look forward to in the future. I think another piece of this is the expansion of indications. We’ve only started to scratch the surface on engaging this therapy in chronic low back pain, but are there other pain conditions potentially that we could resolve the underlying cause for? That’s to be determined through our additional clinical work that we need to do. We know currently today ReActiv8 is not an MRI conditional device, that too can have some payer concern because they do not like paying for devices that get implanted, and then they’re explanted for reasons that might not be justified. So we know the payer community as we drive towards MRI conditional labeling with ReActiv8, which we hope to see in the future, that will expand indications for this therapy. It will expand adoption from the payer community. I think also just a general better understanding of neurostimulation for chronic low back pain by the payer community is needed. They apply a lot of their basic awareness in the spinal cord stimulation space in using palliative strategies. They understand those therapies because frankly, they’ve been around 20-plus years. We’re a disrupter in the market. We’re a peripheral nerve stimulator with a completely different mechanism of action that supports how our therapy works. We’ll see better payer understanding, yield to better adoption and policy development as that time is forward. So those are some of the things I see coming our way over time. None of this, in my view, happens overnight. It’s a continued cadence of evidence generation, awareness campaigns, clinicians weighing in, society stepping up, and creating position statements and guidelines that are supportive of appropriate patient selection that get us to the point of more broad adoption across the US market.
Saul Marquez:
Thank you for that, Chip. And you know, there’s a lot of innovators in health tech that are in a similar spot. Where do you find your inspiration to stay with the game, you know? Because it is like you said, right? It doesn’t happen overnight. Where do you get your inspiration for that?
Chip Moebus:
It’s, I tell you this, this can be a slog. I’ve been very fortunate to work with people in this organization that have been here for ten-plus years, like Jason Shroff, JP Himmelstein, and Burnside. These folks have been a part of this journey of evidence development for this therapy for ten-plus years. It’s the patients. When you talk to a patient that’s had the opportunity to get access to ReActiv8 and use it the way that it’s been designed to use, and you hear about the outcomes with these patients. While some would argue that’s just anecdotal understanding, it really isn’t. These are people that were part of our pivotal trial, that was part of the FDA approval for this therapy. And our inspiration comes from helping people that truly don’t have treatment options and knowing what we’ve seen other patients do with this therapy, that’s our driving force. It is all about the patients. That’s the culture of this organization. We’re a patient-centric focused organization led by science. We continue to invest in science to better understand this population and how we can be better helping them. But those are our drivers, Saul, right now, is really about the patients that we’re able to help, because it’s remarkable when you talk to some of these patients.
Saul Marquez:
That’s amazing, Chip, I appreciate you sharing that. And, you know, and chatting with a lot of the team from Jason at the helm, to yourself, and some, and even your customers and patients like, it is evident to me that patients are your North star, so I appreciate you sharing that. And for anybody listening to this looking for inspiration, man, I mean, it gets no clearer than what Chip shared. Make patients your North Star, you cannot go wrong with that. Chip, I can’t thank you enough for spending time with me today. I certainly am a fan of the technology, of the team and the work that you guys are doing. So wishing you guys all the best here in the coming months.
Chip Moebus:
Saul, thanks so much for the opportunity. It’s great to be with you today.
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