Hello, everyone, and welcome to today's webinar, entitled Advancing Diabetes Care, Policy Perspectives on Technology Access. I wanted to introduce myself, firstly, my name is Estella Everett, I'm an adult endocrinologist and health services researcher at UCLA, and I am the moderator for today's session. I'm also on the leadership of the Diabetes Technology Interest Group. So I wanted to first review our agenda. We'll start with some introductions and announcements, and then we have our two speakers who will give their presentation, and then we'll end the session with the question and answer segment. So the presenters will be taking questions from the audience at the end of the event. Please don't wait until the end of the session to send your questions, instead, go ahead and type it into the Q&A box in the control panel. Please be sure to use the Q&A box and not the chat function for questions. During this announcement segment, we will use the chat box to send your important links, and you can also use this place to chat with other attendees. I also wanted to pitch our next month's diabetes technology webinar, entitled Integrating the Use of CGMs in Clinical Practice, the Interpretation and Documentation of Personal and Professional CGM. This webinar will be taking place February 20th, 4 p.m. to 5 p.m. Eastern Time. And please use the QR code or the link in the chat to register for this webinar. I wanted to also mention another benefit of being a part of the ADA membership is connecting with members of interest groups on the Diabetes Pro membership forum. So continue the conversation about the topics covered in this webinar by checking out the Diabetes Pro forum, and there's a link in the chat on how to access the forum. Now I'd like to introduce our panelists. First we have Dr. Ananta Adala. She's a pediatric endocrinologist and physician scientist focused on reducing disparities in type 1 diabetes care and outcomes among underserved youth. With expertise in pediatric endocrinology, epidemiology, and behavioral health, she examines barriers to optimal type 1 diabetes care at the youth, family, provider, and system levels. Her research highlights worsening socioeconomic disparities in pediatric type 1 diabetes provider bias against public insurance and negative impact of insurance-related interruptions on diabetes technology use. Dr. Adala also champions justice, equity, diversity, and inclusion in research through her leadership roles at Stanford University and as a co-chair of the TrialNet's Underrepresented Minorities Outreach Committee. Our second speaker is Aaron Turner-Pfeiffer. He is a senior director of health policy at Breakthrough Type 1 Diabetes. He brings over a decade of experience in public policy development at the federal, state, and local levels. He is a seasoned political and policy analyst with deep expertise in health care policy, including prescription drug benefits, commercial insurance markets, Medicare, Medicaid, and health insurance marketplaces. Throughout his career, Aaron has worked to positively influence the national and state policies related to health care quality, cost, access, and utilization. His expertise extends to public and private health plans, specialty pharmacy, pharmacy benefit, workers' comp, managed care, and provider network adequacy. Aaron holds a master in health administration from George Washington University and is dedicated to shaping policies that improve health care outcomes and affordability. So now we'll start with our first lecture or talk from Dr. Adala. Thank you so much for that great introduction, and what a team dynamic duo we're here together today, Aaron and Dr. Everett. So today I'll really be sharing on policy perspectives on technology access, but from the standpoint of a clinician and researcher, because that's really where I can best lay eyes on what my work has been and what it entails. I have no relevant disclosures. I do have funding support that I'd like to acknowledge here. And I'm really going to have the majority of this conversation that I'm going to do today. It's really focused around identifying areas of action. That really is what it means to take a policy perspective. And for me, the simpler things are, the better. They tend to resonate for me. So I really have focused on trying to identify that area of action as the intersection of where we know things work well, and we know it's not reaching everyone. And for me, as I started my career and really dove in, this is actually a very recent paper out of the Type 1 Diabetes Exchange published in 2023. And what this is, this essentially is looking at characteristics that put a person living with Type 1 diabetes, the likelihood that they're going to be in target, slightly above target or well above target A1C. And what you can see is there are quite a few sociodemographic factors, meaning the age of an individual. And this is a youth study as a pediatric endocrinologist. That's sort of what I focused parts of my career on. But policy implications go well beyond the pediatric population. And you can see that the duration of Type 1 diabetes, for example, is a risk factor, along with the type of insurance and the race and ethnicity. But as I looked at this, what has been really exciting is very few things, particularly when you look at things from a public health or a policy perspective, very few things can we modify. And for me, I was excited when I saw a modifiable risk factor emerge. That's a common concept we talk about in public health, modifiable versus non-modifiable risk factors. And whether someone has access and has the ability to use diabetes technology clearly emerges as a modifiable risk factor. Now many in the audience will know that really it's in the last decade that we've seen the flourish through formerly JDRF breakthrough T1D CGM studies and all of the innovations that have come out in general. And one of the questions that was asked in 2020 was, are we healthier with diabetes technology and the way that we've rolled this out? Many of you may know this curve on the y-axis is the hemoglobin A1C, and on the x-axis is the lifespan. It's age. So I'm stepping out of my pediatric-centered life here to really consider the lifespan. And in the orange line are the hemoglobin A1Cs that were documented in 2010 to 2012. And the blue line is the A1Cs from 2016 to 2018. Now by that point, we've had early automated insulin delivery. We've had continuous glucose monitors monitoring devices that were reliable. We've had increases in pump use. And I think this was a moment of reckoning for the diabetes community because it was clear that despite having technology and technology rollout, we weren't actually healthier as an entire population when it came to our A1C, and particularly our adolescents and our youth. And this is the question of why, right? And one of the reasons could be that there's this old adage, right? A rising tide lifts all boats, which having not really grown up by the sea or done much boating, I'm surprised how much I think about this saying. But this was a study that was done out of the SEARCH study. And what they did was they said, let's try to understand what is the propensity that someone might get an insulin pump. Now these are slightly older data sets, so really more continuous glucose monitoring wasn't common at the time. And so I'm using insulin pumps here as a proxy for diabetes technology use. And in this study, they chose to compare non-white individuals to white individuals. But you can sort of infer this to any version of marginalization. And in the red are those individuals who identified as non-white, and in the blue are those who identified as white, which you can hopefully see on your screen is that the likelihood, the probability of receiving an insulin pump was much greater if you identified as white than non-white. And because this was pre-CGM time, primarily, self-monitoring blood glucose was a really reliable proxy for engagement with somebody's diabetes care. And what you can see here is that the engagement probability didn't really change, meaning that no matter where you belonged, you tended to engage just as much with the actual finger stick blood glucose. And on the y-axis is frequency, it's not sort of rates, it's just the counts that they had. And what they did really interestingly, and this is sort of math to the rescue of humanity and altruism, is they said, what if the individuals in red got their rates of pump use as just like the individuals in blue? And what they found was it wasn't just the individuals that are in the red here that they benefited, but it's really that the entire populations mean A1C increased 0.33%. Sorry, decreased, it improved, my apologies. And so what you can see is perhaps the way that we're getting technology into the hands of individuals, and the fact that some are able to get it due to policy considerations and some are not, might actually be driving that rise that we saw. And I'm going to present another set of data here, where this was a study that we did with our German colleagues, really kind of comparing CGM use. And now the light blue bars are that same 2010, 2012, if you remember that was that orange curve. And then the 2016, 2018 is this darker curve. And what you can appreciate is that first off, everybody has started using continuous glucose monitoring a lot more in 2016 than 2018. And those of you who live with diabetes or have cared for individuals with type 1 diabetes know why, right? The sensors were only modestly reliable back in 2010, 2012, and really the user-friendliness and capability really grew in 2016, 2018 time period. But what you can hopefully also appreciate is that there was a preferential, really a preferential uptake of this innovative technology in those individuals who have the highest socioeconomic status, which is a proxy for policy level access. Now the way Germany delivers their healthcare is a little bit different. And so what you can see is that they had the same robust increase in continuous glucose monitoring, but this cut across socioeconomic strata. That's what SES stands for here. That really didn't matter where they sat because of their care delivery. And so in America, it does seem like it has to do with our policy or our system level factors that have brought us to the way that people have taken up diabetes technology. And now coming back to that kind of greater good, the sum is, and what you can see here is the A1C at that same time period. A couple of take homes is that certainly there is a socioeconomic relationship, higher A1Cs or lower socioeconomic strata, but what you can hopefully appreciate is it's again, coming back to that same concept that that search study showed, that when we don't equitably distribute or equally, or kind of make sure that everybody has an opportunity to access diabetes technology when they have type one diabetes, you can hopefully appreciate that even the highest socioeconomic strata, those youth also had a rise in their A1C. And what you'll also notice is that we see the same pattern of some, it's not as robust, it's the A1Cs are lower, but we do still see a pattern of A1C and socioeconomic relationship in Germany. And that's because poverty and the burden of poverty tends to go outside of a single solution like utilizing diabetes technology. And so the cost doesn't sit just in being able to access and utilize technology. And there was a very large, almost 284 participants, which is very large for a qualitative study that was done in the United States and the United Kingdom, where really families, so it was sort of four groups, it was individuals living with type one diabetes, their spouses, their parents or caregivers, and now a fourth group that I'm forgetting, but there was sort of four groups that came together and they really gave their perspectives on what does it mean to really, what is the cost of diabetes technology use? And this is a really important consideration because there's sort of the obvious, the literal monetary costs, out-of-pocket costs, but many of these individuals got to a more existential almost understanding that there is a cost to society when everyone doesn't have access, a consideration that preventing costs, preventing chronic conditions, sequelae of chronic conditions costs less than treating whatever happens. And so I present these data just to kind of let people know that when we're talking about policy changes, often we're talking about the direct monetary costs, we're talking about insurance level coverage, but for many individuals living with diabetes, the cost is multifaceted and sometimes that cost isn't in money. It's in a lot of the youth expressed guilt that they were feeling like their diabetes technology costs their family, money, time spent, et cetera. And the other piece that I try to do when considering policy and what that means is what I call the moving gears of diabetes innovation. And we have really in the last decade have been just witness to what innovation can look like. And the way that it broadly does is basic science concepts, things like the oxidation reaction that occurs on a continuous glucose monitoring wire to the immunology of type one diabetes. Some of those innovations lead us to clinical trials that help us understand how to use a sensor, how to use a longer duration insulin, longer acting insulin, or disease modifying agents like some of the new immunotherapies we've had. And the information from these clinical trials really informs what health policy we choose. If the study is ineffective, that is not going to be part of our health policy solutions. And the health policy is really what drives our clinical care. What do we get to do as clinicians? And then that clinical care through real world data, through learnings that we've had, oh my gosh, we thought this worked really well in the clinical setting, but once we come into clinical care, we have these issues. And so it's this very dynamic relationship. Hopefully my basic scientists colleagues will forgive me that I haven't fully looped them into the whole thing, but they really are the genesis of where innovation starts. And so when any one of these arms are not considering the entirety of the population living with diabetes, we can inadvertently have differences in care and differences in policy generation. And so I'm going to pick on continuous glucose monitoring a little bit more. And what we noticed at Stanford, and it was kind of the impetus for this rather large retrospective study where we did a lot of record reviews, was we went in and we said, okay, for our kids who have public insurance, which is a very specific policy rules at the time that the data were abstracted. If you had public insurance in California and you were a kiddo living with type one diabetes and you wanted a sensor, you needed to present that 30 day, four checks per day or more blood sugar log in order for you to get coverage. And then we had to resubmit it every six months in order to maintain coverage. And what we were finding was that many kids would end up having breaks and interruptions in their continuous glucose monitoring access, frankly, because of paperwork, because of how, just how cumbersome it was. So we looked at our kids, there were about 264 kids and 149 of them, they never had to use CGM because they could never quite make that mark of all the checks that they needed to do. And then you had about 115 that were used, that use continuous glucose monitoring. And you had a large portion that had discontinuation or interruptions because of insurance around 75%. And then you had about another 25% that discontinued because they didn't want their friends seeing it. They had skin irritation. It just kept falling off. They didn't like the beeps. But a majority were because of insurance mediated interruptions. And what you can see is that there is definitely a difference, a statistically significant difference between the never users and those who consistently use CGM. But we were really interested thinking from a policy perspective, how can we ask policy relevant clinical questions, clinical research questions? We were interested in this group because really an A1C change of 0.3% is pretty exciting and anything above 0.5 is associated with changes in micro and macrovascular outcomes. So this seemed relevant, even though it wasn't statistically significant. So we reset up the entire analysis or sort of, you know, we looked at each one of these youth and said, okay, can we look at the change in hemoglobin A1C from before they started their continuous glucose monitor to right after, which is that first column. And then we paired all of the visits and said, okay, if you had CGM at your prior visit and you have it now, that's uninterrupted CGM use. If you had CGM at your prior visit, but you don't now, that's the initial loss. If you didn't have one at either, that's a continued loss. And then if you didn't have a CGM, but got it again, then that would be CGM regained after loss. We only did this analysis for those who had any exposure to continuous glucose monitoring. So that group I showed you earlier, where it was the never users, they weren't included in this section of the analysis. And what you can see is something that is really impressive and really telling about what health policy can really do. Keeping in mind that the majority of the interruptions were because of insurance-mediated interruptions. When youth had consistent access to their sensor, they had very similar improvements in their glucoses to those kids with private insurance. But the moment they lost reliable access to their continuous glucose monitor, they didn't just go back to where they were before they had started their CGM, their A1C actually worsened and it worsened as much as 0.5%, which again can really change your long-term outcomes. So this is a study to really show what some of what can be considered a little boring, paperwork, prior authorizations, is this a DME benefit or a pharmacy benefit? Some of these things that can feel very granular that end up determining some of these outcomes for these kids because of how the care itself is delivered. And as we know, as we look across, this is a figure that's somewhat regularly updated from our friends at Diatribe. And what you can see is there is a great amount of heterogeneity in how coverage is done across the state, across the country. And even within a state, there's some state by state variation on how exactly the coverage happens. So for me here, I'm currently in taking clinic in Alameda County, that's slightly different than how Monterey County covers. And so you also have a ton of granularity. And unfortunately, the sum result of all of this type of health policy is that you have interruptions, which we've just shown, and that inconsistent access really results in that rise of A1C of at least 0.3 to 0.5%. It makes it really challenging to deliver care because clinicians end up spending a lot of time on prior authorizations. And there's also this sort of lack of trust. Oh, what's the point of putting that paperwork in? Because I know it's gonna get to be problematic. And when we don't even have statewide reliable coverage, it makes it even more challenging to divide nationwide solutions whether I have families and kids that are in California, but they're gonna go to college somewhere else and to know that they can reliably, no matter where they are, get their technologies is a really important component. And then the last piece that I think is perhaps the most challenging for me to take on is clearly automated insulin delivery is the future of and is the current, it's the standard of care for diabetes technology. But when it is so challenging just to onboard a continuous glucose monitor, there is a data that there's hesitancy towards onboarding a second device. So health policy and policy orientation really does matter. And so really what can we do, right? Because I try not just to list all the problems, but there is definitely a solution. And the very first portion is that technology access is a first step. And it's something that as a clinician I can do, I can make sure everyone sees it. So as an example, the 4T study, which is what these data are gonna report on, the long and short of it is it aims to get every single youth with newly diagnosed type 1 diabetes who shows up at Stanford, continuous glucose monitors within 30 days. We've been batting at about 10 days or so, less than 10 days on average. And what you can see is insurance status, which is a real reliable proxy for how policy is rolled out. I'm gonna orient you to this. So this is the proportion of our participants who have the target A1C of less than 7%. And we went with A1C rather than time and range because we compared to a historical cohort that's here in gray. And you can see that those individuals with public insurance are in the lighter bars. And those individuals with private insurance are in the darker bars. And at month three, since diagnosis, you can see the historical and 4T cohorts are all about the same. But by month 12, you really do see this kind of improvement, right? Where those kids with public insurance and the 4T cohort do better than their historical counterparts. Now you can still see there's a gap, but that gap maintains, it doesn't get worse. Like we saw in that other study that I showed you where we compared with Germany. The second piece in trying to understand what we should be doing is it's how you benchmark really does matter. So I showed you some pilot data from 4T. This is now the study one data. And what we realized is it really mattered how we stratified our data. Now, if we looked across race and ethnicity, if you identified as Hispanic in our cohort, the A1C was 7.9, which is a vast improvement from where it used to be. And if you identified as non-Hispanic white, the A1C was 6.5 and you had a delta of about 1.5. Whereas if you compared in the next study phase by insurance status, that difference changed by about 0.6. And then there are some individuals who are trying to understand, there's some studies that are looking at area deprivation, which is really a neighborhood level factor that's meant to get at social determinants. And there you can see the difference is almost negligible in the case of this kind of Bay Area study. So it really is kind of how you look at things and how we choose to benchmark really lets us know where our policy angles should be. And much of our focus to date has been just around that. And for the researchers in the audience or those people who just love data like myself, I think I would make the pitch that it's really helpful to take a deeper dive into the data. Now, this is the table one from that study that I told you that we looked at. And I'm gonna highlight here is CGM wear time. Hopefully you can see that pretty well on your screen. And the banner is covering it, but the very first column is the overall use, 92% wear time for the entire cohort. But then if you identified as Hispanic, you wore it at about 52% of the time. And if you have public insurance, you were at 62% of the time, which is vastly different than what we were seeing on a clinic day-to-day basis. So after lots of back and forth and talks with our biostatisticians, we realized it's actually not the insurance status and it's not the ethnicity, which is for kind of where we are, that's really the better racial ethnic minoritized determiner. It was really whether somebody had a connected cloud-based device, which was an iPod or an iPad, something that really talks directly versus if they had those receivers that you get with Dexcom and Libre devices. And so what we saw was if you had a cloud-connected device, you artificially, you had a higher wear time than if you had a receiver. And as we thought about this, what we realized is it actually had more to do with the receiver than the person's sociodemographic. We would pull the data at set times. And if it happened to fall within those two weeks and you had to put in a receiver download because you happened to be in clinic, then you would get credit. But if you didn't, then you wouldn't get credit for wearing your CGM. And we realized it was just a process issue on our part and it was artificially making it seem like folks wore it lower. So I kind of gave you three examples of how, the reason why I pause on this is because much of these data are what are used to inform future health policy. All of these studies that we're publishing as researchers truly inform, that's why we say, why the 30 days of blood sugar log came. It's because some of the early CGM studies showed that if you wore your sensor 10 days or more or 70% or more, the sensor was more effective. And then they said, well, who's likely to wear it more? Those people who checked four times a day and then voila, it became health policy. And so I think really understanding and giving context to a deeper dive into data is really helpful. And then I'll close with this, which is sort of, I gave you just a couple of examples. How do you measure the data? How do you analyze the data? As a clinician, how do you make sure you get technology into the hands of people? But there's many roles we all have. And this is out of a commentary that I wrote around automated insulin delivery and how efficacious it is for youth. And so this happens to be focused at automated insulin delivery, but truly these are evidence-based strategies to try to think about what we can do in order to make some changes. So in my case, I do it at the clinic level, both in where I do clinic and how I do clinic. It's in the type of research questions I ask. It's in the fact that I will journey with the ADA in March and go to the call to Congress and start helping disseminate what the best evidence base for future health policy are. And so these are some other solutions that we really have because as we understand what our roles can be and where our time is best spent and those places where we can say, ah, I see where the misconnection was, let's help fix it. Let's help fix it. We really can get to a place where our health policy is really reflective of excellent care delivery, which is what we're looking for. So I'd like to take a moment to acknowledge the behemoth of support that, and people who have worked together on all the work that I presented. And I will go ahead and hand it off to Aaron so that we can continue this journey on health policy and what that looks like. Thank you, Dr. Renata. And I'm excited to follow. I'm gonna build off of some of what you have talked about here, but first I'm gonna try not to embarrass myself and pull up some slides. Let's see here. All right. So hopefully everyone can see this in the chat. Please let me know. Okay, I saw a thumbs up. All right, we're cooking now. We're cooking now. So I'm gonna talk about Breakthrough TUND's policy perspectives here as it relates to technology access, but I wanna highlight and underscore, and we'll highlight this throughout the presentation. I'm a stickler for verbiage, and I think we're gonna talk about policy here, at least as we think about it on the Breakthrough TUND side. But access is really much larger and it really is kind of an effort and partnership, not just between kind of folks focused on policy and maybe government policies, but also as a collaboration with the clinical community. And these two areas have to work in tandem for us to make sure that folks have access to the devices care and therapies that they need to be as healthy and happy as possible. And so I was excited to hear in Dr. Inaba's presentation, those themes as well, because that's what I'm gonna highlight here. I'm gonna start with just an overview of our advocacy work at Breakthrough TUND. And I'll start with health policy, which is the team that I'm a part of, but we work with health policy here on the policy team, a shocking twist, but it really is a group effort, right? And so our government relations team works directly with elected officials in Congress and the White House on government actions and government efforts that can expand access. Our regulatory affairs team works with FDA, EMA, making sure that there are pathways available for important devices and therapies to get to the T1D community. I should mention our grassroots advocacy team works hand in glove with our government relations team. They work directly with our national network of advocacy volunteers, and they're primarily engaged with their members of Congress advancing T1D care and therapies. And then one of our newer teams here, part of the advocacy team at Breakthrough T1D is our global responsibility team. And this is expanding and elevating care for folks with type 1 diabetes in low and middle income countries. And so a lot of the work this team is doing is building off a lot of the earlier efforts to elevate care in the US and Europe and making sure that folks in other countries have the resources they need to live the happiest lives possible. So that's advocacy here at Breakthrough T1D. And I just wanna just highlight when we're talking about access and when I'm talking about policy today, I'm gonna largely be talking about insurance policy, be it government or commercial insurance. And we know that access has really two components, how we talk about it, on the insurance dynamics and insurance policies, but also the clinical elements that have to do with adoption. And I think when we say access, we're really talking about is we want folks to have use of, especially in this case, devices, be using the devices themselves that we know can lead to better health outcomes for folks. And so, we are just now at Breakthrough T1D kind of building out our medical affairs team to enhance our work with the clinical community, have for a long time been working directly with the ADA and you all on standard of care related issues. And we know these elements have to marry together on the policy side to truly have an impact. And so how we've approached making sure that everyone has an opportunity to get access to a device that works best for them is to tackle this by major insurance segments. Couple of reasons of there, happy to go into the background if folks have questions about that. But we just published not too long ago, a paper in concert with the Milliman Consulting Group, looking at claims-based data in the type one community to identify where folks with type one tend to get their insurance. As you can see here, vast majority of folks get their insurance through the private sector and then Medicare following and Medicaid. And I think, to celebrate small victories, I think this Medicare number was larger than we were expecting. And it was certainly a testament to the improved health outcomes folks with type one have been using over the last decade with their devices. And before I talk about kind of where we're at today and where we wanna go with device access from a policy perspective, I wanna highlight the work that Breakthrough T1D has done over the years in concert with likely many of you and certainly the ADA to advance, we call it the pipeline to advance device access throughout the pipeline, starting with making sure there are pathways at the FDA available. So all the way back in 1999, getting the first CGM approved by the FDA, the first AID system coming 13 years after that in 2012 took a while after that first approval to get Medicare to move coverage policies for CGMs in 2017. But then we're here today in 2025 with CMS now covering all available CGMs and pumps and by proxy AID systems that are available and on the market. And so tremendous progress over this 25, 26 year period now. I wanna highlight that there's a lot of work that folks have put in to get us where we are today. So I wanna make sure we celebrate the work that's been done, the victories that have been done as we talk about maybe some of the looming and current policy challenges. So I wanna be specific, there are many things to celebrate here looking back on how far we've come. And when we look at kind of where things stand from a coverage perspective, there are some significant victories here. So on the commercial insurance side, there's broad coverage for CGMs and insulin pumps, AID systems, automated insulin delivery systems. Although I think the lexicon now is closed loop systems as well. CMS has been using some of that terminology. We use AID systems still. The top 50 health plans, commercial health plans now have pathways to cover both pumps and CGMs. And that's a tremendous victory. It's certainly been one of our goals here on the advocacy side for the last few years. Medicare, slow, true to its form in many respects, was slow to cover CGMs in 2017, officially finalized their initial coverage policies. And this was after a lot of work, not just by Breakthrough T1D, but by others in the community to advocate that Medicare expand on their coverage in this way, Breakthrough T1D and others had to publish reams of data and research to convince Medicare to move in this way. But once we had movement in 2017, saw them modernize and simplify the requirements to get access to a CGM in 2021. And then by the end of 2021, saw CMS finalize coverage policies that expanded access to all CGMs on the market. And so a lot of work went into there, maybe not satisfied with where we are in the Medicare space, but certainly like the directions and positive signs coming out of CMS as it relates to coverage on CGMs and AID systems. Medicaid, leading states cover CGMs and AID systems for children. That's certainly a positive step. The Medicaid tends to lag, sadly tends to lag Medicare and certainly commercial insurance and it's written policy documents. And so there are some states that may be covering CGMs and AID systems in a routine way that's in compliance with standard of care now, but only a handful of those leading states today or have published policies. And if it's not written down, as you all know, if it's not written down, it's hard to really hang your hat on this as a guaranteed policy. And so significant work to be done in Medicaid, but certainly victories here as it relates to coverage pathways on the commercial insurance and Medicare side. What are the emerging issues that we're tracking on the commercial insurance side? You know, and this is true of Medicare as well as the technology evolves and gets more sophisticated as the reliance on the digital component, particularly the phone becomes more important, how to coverage policies and reimbursement policies for the practitioners who are prescribing these, do these keep pace with the evolution of technology? As I describe it, the sign of success all too often in the insurance system is if you see, if you have multiple options available and insurers are no longer challenging the utility of the drug or the technology, but they're picking their favorite, and it's a sign that you've kind of crossed that hurdle of acceptance. The challenge is here that we run into situations where not every device works for every person the exact same. And so you have insurers picking winners and losers for folks in their enrollment plan that may not be the best option for them. And so that's certainly what we're seeing on the commercial insurance side. We know plans are picking their preferred pumps and CGMs, placing restrictions around getting access to others, some outright refusing to cover other CGMs and devices, and some throwing up restrictions like prior auth or more increased costs for out-of-pocket spending to get access to a non-preferred device. So this is something certainly that we hear a lot about. I would say next to insulin affordability. This issue is what we hear the most about. And we're watching pretty closely. We know through both data and anecdotally that there's a migration in some respects to the drug formulary from the DME benefit. We know that once you move over to the formulary, there's an option for you to get a rebate. Certainly assume that that is some incentive in the change, but we're not sure of the impact. We've not seen any clear published data on the impact on access. Candidly, we hear anecdotally from folks in the community, both good things and bad things. Some folks love the move to the drug formulary and have good experiences. Some really prefer the experience on the DME side. And so many of these same components are true on the Medicare side with the added wrinkle of, it's not a hundred different health plan policies. It's Medicare, slow behemoth moving its policies but they're confronting many of the same considerations on their side as the technology evolves. And as you know, we've got users now who have been, who are familiar and have had devices as part of their routine care for, in some cases, many, many years. So this is something that, you know, the Medicare policies are already starting to grapple with, particularly as we think about tubeless pumps, the Omnipod being covered by Part D, but not by Part B, how that interacts with someone's benefits, and if nothing else, the burden on the person with diabetes to have to navigate all this. And Medicaid's in a much different spot. You know, coverage right now varies by state. You know, the coverage around pumps seems to be reasonably okay. Coverage around CGM certainly lags in a significant way to the extent that in some states, there's no written policy that someone with type 1 diabetes gets the standard of care as it relates to a CGM if they happen to be enrolled in Medicaid. And so just getting Medicaid up to where Medicare and the commercial insurance plans are now is an important and significant task that we are focused on. I should highlight, nowhere here have I mentioned affordability and cost. It goes without saying that, you know, it is the insurance pathways are the most relevant pathways to ensure that folks have access to these devices. Very expensive without insurance to get. And, you know, we know that simple benefit design changes or the inclusion of a prior auth or a higher tier of out-of-pocket cost can really impact someone's ability to maintain their care plan. It certainly influences their decisions. And this is something that we're paying a lot of attention to, you know, and it is in some respects caught in kind of the ability of us to derive from the different data sets. What's going on, is it benefit designers or something else happening at a macro level within the market? And so we know that out-of-pocket costs are a concern. We know there are concern in general around insurance design, but we know in particular folks have real concerns about the changes in benefit structure that are emerging as it relates to their devices. So, but if anyone has any ideas or solutions, we are reviewing those now. So we will certainly take those. Hopefully folks will follow up afterward. And I just wanna make a call out here. What are we working on big picture wise? Depending on when you're watching this, the new Congress is just kicking off. You know, we are constantly working on a range of topics, be it insulin affordability, device access with our partners on the Hill. On the time sensitive issue that we're working on today that really is a top priority for us is the renewal of the special diabetes program. And you know, it's been critical. It's a part, it's funding that goes directly to the NIH. It's been critical for type one diabetes research now for the better part of 26 years. Was critical to funding and continuing to advance technology on the, on CGMs and AID systems. This played a critical role in the first ever disease modifying therapy for type one and continues to advance care related to cell therapies and potential cures for type one. And so we are looking for an extension of the SDP. It expires in March. Our folks are already meeting with new members of Congress. They'll be here in Washington, DC at the end of February, early March to try and advance the special diabetes program. It really is critical tool here for us to advance care for the type one community. And so if you're interested, it wouldn't be an advocacy presentation if there wasn't a call to action. So if you've got the time and you're interested, your voice matters. There's a code here where you can go and sign up. You can be as involved as going to meet with your member of Congress to talk about this or simply, you know, sending an email, letting them know that this issue is important to you. So we'd love to have your voice on this important issue. Here's a code for more information. And with that, I think I'm on time. I will open and ready for questions. And I have some of my own just in case. All right. Well, thank you, Dr. Adala and Erin, for your great talks. And I think it really gave a great perspective on the clinical standpoint and how policy, you know, impacts access as well as, you know, options for advocacy and how policy and how Breakthrough T1D has kind of led some of the efforts to kind of ensure that our populations with type one diabetes have the most access that they can. So I wanted to open it up now to questions and I don't believe there are any questions in the chat. So I encourage the audience to add any questions you have, but I can maybe start with a question slash comment that I had and maybe this, I think it fits within both of your talks. And so it's really about Medicaid policy surrounding diabetes technology. So I definitely lucky to be in California where I think our Medicaid policy is quite generous and especially after 2022, where there was like a huge policy change. And I've, as a researcher, I've done a few studies looking at the impact of that change. And in one of our, when we did an evaluation of patients at UCLA and one of our safety net hospitals, we saw like a 66% increase in CGM use. And when we looked at that policy, Dr. Dollar, you mentioned about having to check your blood sugars four times a day, the amount of patients who were unable to meet that criteria and then were able to, you know, now get CGM was huge. And their change in A1C was about one and a half percent change in the first three months after using CGM versus the group that, you know, met that criteria was much less. And so that really, you know, pressed upon us like the important, the big impact that policy has on access and as well as glycemic control, especially in these populations. And so my question, obviously as a researcher, I think from a researcher's lens, you know, we submitted that paper. It was recently accepted in diabetes care, but I wonder like that is, I guess, in one way that I think of like, let's show this data so that other states can see, wow, this has a huge clinical impact and maybe cost savings and really maybe inform that policy change in other states. What are your thoughts on how, specifically in the Medicaid population, because there's huge variability across states and I have colleagues that like, even in their type of ones, it's a really hard to get CGMs or pumps. How do you think we can better influence policy on the other states that are much more restrictive? If, Erin, I'll take a first stop because it's really exciting to see, to hear others recognize the same thing and it's no surprise that you have. So I'll actually pull the curtain back on how that 2022 policy change occurred. And it occurred through not legislative changes, which is, you know, kind of you're going to your lawmakers and you're saying, hey, this needs to be a law. It was those changes actually occurred through a regulatory standpoint. So the coverage actually didn't change, but the number letter, which is how is the coverage going to be applied? That's the piece that got changed. And that's why in 2022, it was easier. And part of how that change came around is California and California Medicaid and California covered children's services, CCS, which is the body that funds individuals who have type one and their coverage. There is a group of pediatric endocrinologists that represent across the state. And I'm lucky enough to sit on this panel of the technical advisory committee. And so there's sort of a unique joining of things. And I want people to know what are the competent factors that went into this. So you can identify those in your world. And so it required a medical director who was willing to hear us clinicians who were the boots on the ground. It required us clinicians to sit down at this technical advisory committee and say, hey, you know what really sucks? Those prior authorizations and those 30 days of blood sugar logs. It also took that paper that I shared where we showed that the paperwork was actually worsening glycemic outcomes was a key component of the data that drove the medical director and then the policy they're in to remove those from the number letter. And it took also the change from continuous glucose monitoring being a durable medical equipment which required communications with suppliers to a pharmacy benefit, which allowed for it to be directly dispensed. So it's sort of these multiple component parts that came into now you have actually not even type one, insulin requiring diabetes is actually the change that we made in that number letter. And again, none of that is actual legislative changes. There was also legislative changes that occurred but these specific changes that we've witnessed day to day those are all regulatory. Those are all how the law is interpreted and how it's applied. And so I couldn't, I was thinking about things that I'd missed in thinking about policy. And I think we act on the legislative component but I think thinking about where the regulatory changes can happen and who's making those decisions. Cause once they realized that glycemia was worsening because of the 30 day blood sugar log it was a no brainer to pull it. And then now the last piece I'll add is in order for national advocacy and for legislative changes, there is a line now in the ADA standards of care that says we should not have interruptions because it worsens glycemic outcomes for people. And so now people can go to that line which is our national standards and use that as a lobbying and kind of leveraging technique to say this is actually the medical standard of care. Wow, thank you, Dr. Adala for that. I definitely, it was great to hear some of that background of how those changes have been made. And hopefully there's some like gems there maybe that could be applied to some other states to kind of get a similar result in their states as well. And I agree that change making it even broad even are the patients with type two diabetes have really benefit. Cause I have another study at FQHC and the impact like the rise in CGM use was so dramatic. And so I think it's important for type one but there's really great benefit in type two as well. So I'll maybe ask Erin, what are your, although you're from breakthrough team 1D, what are your thoughts on how this could be applied to some of the policies related to type two diabetes? Yeah, no, and I think what's so interesting here and what's so important for this community. And I think Dr. Ananta just mentioned on how important not only data is but the voice of the practicing clinician. I think that's true as access to devices for the type two communities now the standard of care as well. And many of the challenges that we experienced on the type one side, close questioning the utility of these devices in this community and then having to go get data and bring data. We're kind of in that phase now. And then the other phase is once you've got the data you've got to really wave it in front of the faces of the decision makers, right? Because everyone says that what they're advocating for is we'll improve care, we'll improve quality, we'll reduce costs over time and getting those folks' attention and ensuring that there's broad alignment on this not just from the clinical side but from the community's perspective. So they're aware of what's going on. I think it's so important. I think this, us as a larger diabetes community, as we're working toward expanding access for what, I'm not a clinician, I am an advocate and a policy person. So I can say what I know makes sense. Like if you just describe it to me, what you all are saying is like, okay, I guess we'll go get data to prove to you what logically we know to be true I think is an important piece but the data alone is never enough, right? You've got to not be knocking on doors and making sure folks who are making those decisions are aware of what's going on. And so I think that's so important as we ramp up here to expand access to the type two community as well. All right, thank you for that. We do have a question in the chat. The question is, do you have any comments or any vision on policy changes on insurance coverage on CGM use for those who have no insulin treatment? Increasing evidence has shown the impact of CGM use on glucose control for individuals with type two even the shorter term use. However, many type twos do not receive insulin use. Do either of you have a comment on that? Well, I'll give a non-expert opinion here which is always a dangerous place to be. I think there are, I think logic would tell you that it makes sense for someone who, maybe a screen positive for two auto antibodies and we know is heading toward a stage three type one T1D diagnosis to put a screen positive put a CGM on them maybe periodically to monitor and get them maybe comfortable with CGM. I know those are clinical conversations that are happening if that makes sense, is that worthwhile? Is that a conversation that makes sense as well as for someone who's not insulin dependent on the type two side but there might be concerns around that. And I think on the insurance side, obviously they wanna see data on this before they do anything. But if we're focused on the person what makes the most sense for the person, these are all kind of logical expanded uses of the technology, especially we now know we now have data that shows showing someone their time and range meaningfully impacts how they live their life and make decisions. So it's really compelling. So the more we can get data in the hands of the person we saw our position has been the better. Yeah, and I think that's certainly true. And that sounded like an expert opinion to me, Aaron. So I think you should- They let me hang around the room enough that I can't pick it up. I'll add a sort of a policy level nuance, which is, and I'm certainly gonna be biased as a pediatric endocrinologist, but I think there's a pretty, the evidence base is extremely compelling that pediatric type two behaves and progresses quite differently than adult type two where you don't have the likelihood of someone being sort of a long-term latent sixes or so and their long-term cardiovascular outcomes and microvascular, there is a clear difference, I guess, is the take-home message that the TODAY study shows that, RISE shows that. So, and when you think about the expenditure of Medicaid, Medi-Cal, all these public payers on pediatric, like sort of the dollar spent versus non-pediatric populations, I think there is actually very reasonable justification now from a cost standpoint to give individuals who have pediatric type two diabetes, CGM as standard policy, when you really play out the cost effectiveness, the fact that within 10 years of having a pediatric type two diabetes diagnosis, I think that actually technically the year is nine, 50% have micro and macrovascular changes that are recognizable, and I'm diagnosing kids at 12, I'm diagnosing them at nine, at eight, you're talking about a lifelong impact so that if you can curb that rise earlier, I think there is always a hesitancy to increase coverage. And I understand that the pot is limited. And if we could, we would give everyone everything that they'd ever wanted. And I understand the sort of practical limitations. And I think there's a unique difference that is pediatric type two. I don't think it's just because I'm biased. I really think the data are there that you're talking about preventing. You don't wanna have a 20 year old who has micro and macrovascular changes. That's only going to worsen as our arteries resilience goes down, right? Like I'm not, my blood vessels aren't as resilient as they used to be. So in any case, I think there is some attention that could be given to that before saying, oh, well, we can't give it to everyone with type two is too much. And therefore we're gonna make a blanket statement for individuals living with type two. I think that's a reasonable sort of what is the policy I envision is one that allows at least ready access at pediatric type two. But I agree, I think that anyone who has an elevated A1C and has type two diabetes, whether they're on insulin or not, particularly with the efficacy of GLP-1s, I think it's helpful to know. And many of these communities don't have, they don't realize the glycemic index of some of the foods that they're eating because it's hidden. You don't realize how much fructose corn syrup is in there and how much that glucose was gonna spike. So I think that's also another tool for helping people make the right decision. All right, we have one more question desk into the chat, although we only have one minute. So I'll see if we can get a brief and a quick answer and then we'll close the session out. The question is in your opinion, how do you think the new Medicare prescription payment option will affect access to CGM? Alternative insulin delivery systems and some AID systems for some Medicare patients? I don't know if we can do a quick response. We'll see. I think the only thing new we'll see, I think we aren't expecting significant impact, but we are in regular communication with CMS and have an open line to them, but we aren't expecting any disruptions. We're optimistic, at least for the type one side. I don't know about type two, cause that's the new space, but type one side we're hoping it's maybe smoother than it's been in the past. Yeah, and hopefully those ramifications, if there are any are quickly turned right back around with the advocacy of both the organizations that are at play, but also individuals like the folks here, the folks who will be listening later and then all the clinicians kind of, and sort of troops across the board to help make sure there's access. All right, with that, thank you both Dr. Adala and Erin for your great presentations and really those thoughtful answers to the questions. And thank you everyone for attending this webinar. And I hope to see everyone at our next Diabetes Technology Interest Group webinar, which will take place February 20th. All right, have a great evening, everyone. Thanks everyone. Bye.

Diabetes Care

Health Policy

Technology Access

Dr. Estella Everett

Dr. Ananta Adala

Aaron Turner-Pfeiffer

Disparities

Continuous Glucose Monitoring

Insurance Coverage

Data-Driven Policy

Medicare Changes