Welcome to selecting persons with diabetes who are eligible for C. G. M. Reimbursement in the managed care setting. What are the criteria for obtaining who can benefit and how is it implemented? Hello I'm dr Eden miller. I'm the director of diabetes and obesity care in bend Oregon. I am a board certified family medicine specialist and the diabetes ologists and I am a diplomat of obesity medicine. So here are my disclosures. So what are today's learning objectives? We're going to review the glycemic and or clinical criteria necessary to ensure access to C. G. M. We're going to discuss the benefits of C. G. M. To patients and how to select those individuals will also review the necessary steps to ensure wide access, reduce barriers to adoption and maximize benefits to both prescriber and person utilizing C. G. M. And then finally we're going to develop a C. G. M. Implementation strategy in the primary care setting. I want to begin with some of the misconceptions surrounding C. G. M. As I have traveled throughout the last few years introducing and discussing continuous glucose monitoring. I've heard a lot of misconceptions and so I'm going to discuss a few of them here and kind of try and debunk some of those. I think I hear the most oh my person with diabetes, my patient, they're not going to benefit from C. G. M. And they really don't need it. That misconception is really tied to how you as a prescriber view continuous glucose monitoring if you place it in a box If you only utilize it for people with insulin or type one diabetes, you're gonna limit its scope utility and implementation and after this program, I hope it will expand your knowledge of how C. G. M. Can touch all persons with diabetes. The second is that C G M is inaccessible to persons with diabetes. There's a difference between affordable and accessible, affordable is different for every person but accessible is something that we're going to help you understand and learn how to navigate that so we can bring that to persons with diabetes. I also hear that the information see GM will provide us too much. It's going to cause distress. My patients don't want to know what their blood sugars are all the time. And I would say have you asked them rather what I believe is distresses when you don't know where you're going, you don't have anything to guide you or to give you feedback to me. It's exceedingly hard to manage a disease where one time a day you take your glucose blindfold off you do a finger stick and you try to make meaning of where you've been, how you got there and where are you going? The next is as C. G. M. Is too time consuming to implement in clinical practice. That's one of my expertise, how to manage the workflow, how to take time to create that and we will go through some of the highlights of that in this discussion and then finally it reimbursement for C. G. M. Implementation and interpretation is challenging. We do EKGs in the office, we have the machine we set it up, we can put the paper in the medical assistant or nursing staff will administer the E K. G. You get it, you interpret it, you dictate it and you bill for it. It's because it's a tool. It's a diagnostic or therapeutic tool. C. G. M. Is the same and there are specific codes that are reimbursed on all levels. And so we will also equip you to utilize that in your practice. So C. G. M. Systems are way more than a new monitor. They really are that movement beyond point of care. It's what we had in the past. There were times when we used to test urine for glucose prior to that taste it. I'm so glad we had better innovations with that. But point of care, glucose management with glue commoners are probably about 30 or so years old but that's very momentary and limited by how many times you can do it. There's also no predictive or retrospective analysis in self monitoring blood glucose where C. G. M. Provides that it gives you that trend that heading that course and then that data that it archives both for the person with diabetes and the healthcare provider gives us deep individual insights into personal glycemic management. However, you can't manage what you don't monitor. And so we're here today to discuss how to begin monitoring and managing diabetes at such a higher level We know there are challenges and outpatient management of type two diabetes. I am not unaware of those I struggle with those just like you do. There's a high level of what we call clinical inertia and inertia is both sides of the aisle, the person with diabetes, the provider with with the diabetes management and intervention. And I hate to say even those entities that touch the patient, the payer and the policymakers we have quite a bit of challenges to overcome. But the fact of the matter is is that this disease requires a progressive plan of treatment and intensification that keeps pace with the patient and their disease evolution as well as engagement for a lifelong of treatment. Inertia in the field of diabetes is probably highest than any other chronic disease, especially when it comes to initiation of insulin. And it's tight rations because surrounding the whole target of diabetes management is the sphere of hypoglycemia mobile sides. In fact, we erroneously would raise the A. One C to try and prevent hypoglycemia. Uh we know that that's not the way we do it. It's not the destination A one C that confers hypoglycemia. It's how you get there with what agents and it's how you monitor and manage the disease. We see increasing diabetes distress, in my opinion, lack of engagement is directly tied to levels of diabetes distress. The more distressed you are, the more you distance yourself because you do not know how to cope with it. And so C. G. M. In my opinion awakens that engagement equips that individual for improved in lifestyle management treatment persistence as well as the elimination of all the things that happens in their day to day life. Healthcare resource. Utilization is only going to increase. It is estimated in the next 10 years. We'll have 60 million people with diabetes because 98 million people currently have prayer early diabetes and then there's the unawareness of asymptomatic or silent or middle of the night hypoglycemia. Many of our patients don't report it, many of them aren't even aware of it, those symptoms that they experience. In addition we have a high level of mortality and morbidity associated with this. So why is A one C. And self monitoring blood glucose really not enough. A one C. is still the universally accepted standard for the diagnosis and monitoring of diabetes but it has limitation. There's this ongoing debate about what the optimal A. One C. Is. Are you the american College of Physicians say keep it less than eight. Are you the american diabetes association? Less than seven? The american College of Endocrinology 6.5 or even those early diabetes interventional goals of normalization of glucose management to a normal A one C. I rather propose that we should standardize the A. One C. And validated by time and range because you n CS are individualized targets. They're vastly different and they don't represent what the glycemic levels are. We need to base that time and range and risk of hyperglycemia on the patient's age and their life expectancies and comorbidities and time and range targets through the consensus panel. They encapsulate that that is missed by the a. one c. We're also learning that glycemic variability, right? That highs and lows the peaks and troughs is where the complications come from. And A one CS don't capture glucose variability. Neither does self monitoring blood glucose and we can't see that individual variations and how all the components that we do in life and intervention affected. If you are an individual who prescribes a once daily self monitoring blood glucose by this little orange block box that that first in the morning glucose test. Which is interesting how that came about. Why would we check a glucose when the engine the metabolism is resting? That's not where the problem occurs. But it's kind of what we do. If you were to expand upon that and do the four gray boxes of the sMB G. You would get more data right. And this is kind of the maximum amount of testing we can do often in Medicaid and Medicare. But by the connect the dot lines that C. G. M. Provides through the green time and range the orange out of range in the gray hypoglycemia. You can see that you get a very different story from a point of care once daily on blindfold, four times a day, look around or continuous streaming real time glucose monitoring because all of this gets missed and all of the treatment intensification opportunities, the learning for food and those issues they get lost. We cannot see that. And so imagine we had a person who was on basal insulin. Right. That was one of the things that they were doing for their glycemic intervention. Imagine we had this one patient, both of them in a one c. By the way of 7.8, both of them within a one c. 78. And each of them had their own unique glycemic profile that A one C. Is not gonna directionally tell you what to do. The one patient with the A one c. of 78 and the brighter color has pretty good glycemic variability, albeit their higher they can actually benefit from thai tradition of their long acting insulin. Yet the under other individual in the darker color same A one C. Has morning hypoglycemia significant and postprandial highs. So the glucose variability that we see illuminated by continuous glucose monitoring is the directional change. We need to go. It's a safety thing after all. And so A one C. Doesn't equip you with enough metrics for tight rations recommendations. So let's transition to who could benefit from continuous glucose monitoring. As I said, A one C. Is just an average, it's an average B. That doesn't tell you that whole glycemic story. If you have individuals that have that A one C. And it just doesn't seem to make sense because they're telling you I have this A one C. But my morning blood sugar is awesome or I'm having lows in the morning. Well why is your A one C. Not on target. And so even a baseline C. G. M. To look at all the different glucose is they visit will help make sense. Well to the patient and the provider. I also believe C. G. M. Is in a massive awakening engagement tool because those people who don't engage it's not that they have a death wish. It's not that they don't care. They just don't know what to do or where to go. And so in order to cope with that they detach from it. So imagine you give them a tool that helps them with ownership lessens the burden of diabetes but gives you the information and the direction and you got to make sure that you don't encapsulate it and shame and blame right? These this is information, glucose levels are not your self worth. They're just places you visit. It's also essential. We know that that safety component of C. G. M. Is there those that are in danger of hypoglycemic through their treatment plan or their disease state or their other comorbidities. Or if we just want additional insight the person wants to know what foods bother me. What happens when I'm stressed? What happens when I don't get enough sleep or I exercise or I forget to take my medications. It's data and it gives the power or the information to both the person who suffers and lives with diabetes every day. And those providers who have ongoing care it's an amazing tool because we don't have very many tools that are both forwarding and beneficial to the patient and forwarding and beneficial to the provider in different ways. There are not a lot of things like that. So if you look at C. G. M and its two classifications we have both the professional and the personal and there are some subtle differences most of the time the professional is blinded but not all of them are blinded. Several different varieties have that un blinded effect. But professional C. G. M. Is that which you as a prescriber can get immediately. Yes you'd have to have a workflow, you'd have to purchase the reader, you would have to purchase sensors through your different medical suppliers, learn how to apply it how to download it. But in terms of its building barriers and its application and and and and coding it's that low hanging fruit. It's the thing that anyone listening to this presentation could start and you would get a great deal of data with the least amount of barriers and inertia but you don't always get all of the benefits of C. G. M. Depending on the model. In addition there's a bit of a workflow of bringing them in, putting it on taking the components. But it's not insurmountable by any means. The device and professionals owned by the health care provider. It is loan to the patient. It can be reused in some cases not the sensor, sometimes transmitter batteries or the application or different things most of the time it's very unique to the person. It collects real time glucose data. Either a blinded or blinded, it can be worn for several days but generally it's about 710 or 14 days and then it's all downloadable and retrospectively reviewed at an appointment. Now if we go from professional C. G. M. Two personal CGM it's that owned by the person and it can be utilized on a daily basis or intermittent basis. It can have a standalone reader linked to a phone or linked to other compatible devices including biometric watches as well as loved ones. They're viewable. Actionable and retrospective and prospective. So they're real time and many of the different models are 7 10 14 days or even implantable at 90 and 180 days where they're either real time, real time streaming or flash or what we call scannable type of versions what do we get both from the person and the clinician to utilize C. G. M. Every person is going to benefit differently but here's some of the things that we see. I like to say it brings diabetes out of the past into the present and helps the person anticipate the future. Very much individually driven. I'm empowering the patient to own their own disease. Guess what? I'm lessening the burden of that responsibility is me as a health care provider. It's a time saver. I'm equipping the patient to manage it. I'm bringing awareness to trend hours up a down stable rate of change. Are you gonna have a hypo are you gonna have a hyperglycemia? Is that predictive If you have the patient journal they'll see the effects of food and activity levels and illness. It also gives people ease of mind especially if you have individuals who may not be as aware of hypoglycemia or aware of their glycemic or need assistance or just that loved one who wants to be able to track the person that they care for with diabetes. What about on the clinician side we get increased engagement, increased responsibility in their own disease. We get protection against hypoglycemia and hyperglycemia. That's a major guarantee it reveals to you as a prescriber the clinical therapeutic impact on glucose what you do what you prescribe what you intensify what you d intensify. Remember it's not all about intensification. In some cases it's de intensification because of hypoglycemia helps you overcome that inertia. It gives you compile a ble printable data to share with the patient to look at patterns through that time and range where we get from the A. G. P. Ambulatory glucose profile and here's the A. G. P. The A. G. P. Is a display. It's not a report card and I want it to be a grade. It's standardized. We have through the International diabetes center. We have the consensus on time and range for the individual for the people who want intensive control, those who need less intense, those who are pregnant and type one. Those who have gestational diabetes and those targets are on all of those reports are standardized. Then we get the subjects time and range value on the right hand side through the graphic of that red, green, yellow and orange. We also get the number of hours that they spent in the percentage. Then we get the actual ambulatory glucose profile picture. It's a great picture to look at that 12 AM to 12 AM. What do you see? What's all of your average data? It's like looking at a snapshot and being able to make some meaning out of it. Then we also get the daily glucose profiles on the bottom to look at those individual days. What happened when you went out for your birthday? What happened when you forgot to take your medication or you overdosed on a medication? Too much insulin. Now we have the new A. G. P. Report coming that glucose patterns insight which you will learn about how it gives you those suggestions to look and say wait a minute. What are the patterns here? How can I match those coded areas and what are the interventions that they suggest. But when it really comes down to it, Besides just all the data and all the individual benefit of C G. M. Right now there really is the right person for C. G. M based on coverage not based on utility and who's going to have the benefit of coverage. So some of the recommendations and requirements is it's a person in the US greater than or equal to two years of age who has diabetes doesn't matter which kind who either wants or needs more engagement outside the US. Unfortunately we can only use C. G. M. And persons with type one in the US. But outside they can use it for gestational diabetes seems a little frustrating but I think we'll eventually get there. It also should be applied to those people who are experiencing hypoglycemia. Those on cell phone areas. It happens hypoglycemia from a cell phone area is the same as that from insulin. They're no different and they're dangerous. And it can occur with basal insulin as you saw in the graphic earlier or definitely mealtime insulin or insulin delivery devices such as connected pins, patch pumps or standalone pumps. What about advanced age risk of hypoglycemia and detection complex patients or those with chronic diseases such as heart failure, kidney failure or mental impairment and the inability to care for themselves or what about people who said you know what I really want to engage. I want to know what happens to me on the individual based on my glucose levels and all the different places I go in a day. So we looked at those individuals who were on either long acting insulin, basal insulin or no insulin therapy is all know insulin therapy at all. I wanted to show you one of the studies that I published with my colleagues and to kind of illuminate a little bit of the misconceptions regarding who benefits from C. G. M. Several of you may say well unless you're on insulin multiple daily injections you're not going to benefit. Well really basil insulin. Okay I suppose basil insulin. But I'm here to tell you that. We looked at those on one basil shot today or those who are taking no basal insulin or no insulin at all. Injectable GLP ones or oral anti diabetic agents. We looked at the retrospective data, we looked at Liberty View, we looked at quest diagnostics as well as the R. G. Looking at medications as well as I. C. D. 10 diagnosis is we looked at the baseline A one C. Had to be greater than 6.5 6 months prior and we looked at the six month and 12 month data and I published this in the 2028 scientific session of the american diabetes association. And here's what we saw here is the A one C reduction after the initiation of the freestyle library system in persons with type two diabetes who either had one long acting insulin or no insulin whatsoever. At the first six months all of the compiled data was on the left hand side. There a one C reduction was 10.8%. That was a whole group at 12 months. It was still fairly persistent but it was at 120.6%. But I want to show you the greatest reduction on the right hand side. Those individuals didn't take insulin at all. They were on oral anti diabetic agents or injectable GLP once. Yet they had the largest A one C reduction at six months at 60.9 and continuation at 0.7% at the 12 month level. Why was that? It's because it illuminated their own glitchy mia. It probably illuminated to the prescriber who typically says oh my patients not gonna benefit from C. G. M. Because they're on oral anti diabetic agents. Really. I think this is one of the most compelling studies for its utility and all persons with diabetes but it's important that you create a workflow because that I don't have time. I can't put it in there. It's not really the case. This is not rocket science. It's not flying the space shuttle. You gotta pause and be purposeful about how to do workflow in your clinic. You have to bring those representatives in. You have to talk to your I. T. It might be just you doing it it might be you talking to your whole team of diabetes who deal with the desktop software for download the workflow the codeine and it could definitely be accomplished if you get all of the team members together. So how do I start? I start by overcoming some of those barriers by my front office staff for schedule. Er I do diabetes only appointments. I know some of you are like you don't understand dr miller I'm a primary care provider. Well so am I and I say to them I want to prioritize your disease that's going to be there tomorrow and the next day yes we're going to get to your other things but we need to cover the diabetes. And I'm going to schedule it in my template as a diabetes only appointment. I'm going to do a reminder call if they happen to have diabetes related technology or connected devices to bring it at that check in. I'm going to begin the process of getting that diabetes related technology. I want to make sure that that app and computer data platforms are updated there on a desktop a dedicated desktop in your particular you know EMR or electronic health record system and that might be requiring the I. T. Guy to do that and I want those persons that interface with it in my office to understand how to access that technology, how to download it, how to either plug it in or how to to go into that viewer and get that data because if you don't download the data you're not getting the full benefit of it. And there's also this chain of command that passes on the necessary task members to other team or other diabetes champions. Now my medical assistant who I have won many of you have several my back office staff. She has an intimate familiarity with the CGM system. She is my diabetes champion. And you need to identify that person who understands the utility and gets how these systems work. There are not that many of them. They need to know the components, they need to know how to set it up. Again this is at a 5th grade level For the patient and it can be also utilized by your staff how to apply it. I apply them all in my office. It takes 3-5 minutes at the very most to do this. How to get the application on the phone, send and share the code for data sharing, approve it all at the visit before the patient leaves. To overcome those barriers. You get it done right the first time you create that workflow and troubleshooting of what to do. That's that initiation. You're the provider, you identify those who need C. G. M. And can benefit you then pass that task off to your medical assistant who goes into the office, applies the system. You can as well, but it's also in their wheelhouse sets up the app gets the reader gets the individual in starting this process, knows how to do it And then gets ready for the data later. Then when they come back in, always bring them in 2-3 weeks after that first initiation or ongoing. And that's where my friend staff communicates with my back staff and I have that data already in the chart. In fact I'm going to work tomorrow and I can tell you right now my staff are are downloading those a gps from the site and it's already in the chart in the documents ready for me to review it with the patient to go through those different components to make that either in person or virtual visit a success. And I often can share this data either virtually or in person or through secure websites with the patients. So you need a champion, you need a workflow, you need the steps as it walks through the office and you can absolutely do that in an hour in your setting at a lunch time. You know, what do they say? A job begun is half done. So let's talk about the Medicare criteria when prescribing CGM. Why why did I do Medicare criteria? Because those are the most challenging. I'll pause for a minute to talk about Medicaid Medicaid is it's either covered or it's not. And in many cases all persons with type one diabetes irrespective of the way they deliver insulin is covered. Type two persons on insulin, it depends it depends on where you're at your region, whether it's with pumps or just with injectables and in some cases it's covered across the board in those persons with Type two and Medicaid now commercial has pretty good coverage. Commercial is generally sent to pharmacy. Medicaid is sometimes sent to pharmacy. Medicaid and sometimes sent to durable medical equipment. Pharmacy and DME are usually commercial. But Medicare is special. Medicare is where you tend to get the most barriers because when you as a prescriber think oh I want to try to get C. G. M. You often make some important missteps along the way. First of all all see GM. For Medicare goes to durable medical equipment. Do not be tempted to send it to a pharmacy that says yes we process part B. As in boy. Don't don't take the bait. Just send it on to durable medical equipment. You must provide supporting clinical indications hypoglycemia, episodes of admission, episodes of transport, unawareness, severe glycemic excursions ability to utilize the technology and that they are doing self monitoring blood glucose but you do not need to document the evidence of self monitoring blood glucose greater than or equal to four times a day. Even though some of the durable medical equipment people are sending that back, it got removed removed in january of 2022. But for Medicare, the current recommendations are that patients are insulin treated greater than or equal to three injections or using a pump occasionally I can get it with basil insulin so don't be afraid to try. I usually say that my treatment regimen requires frequent monitoring that the results I need to see. GM. And that you need to see this patient every six months. You need to document it. You need to download it. You need to address it. You need to say I'm utilizing it and that we're having that either in person or virtual visit. And again I can't stress it enough. Don't send it to pharmacy. You're gonna get a rejection and you're gonna think it's not covered. You need to go to durable medical equipment. So what are some of the essential things for effective C. G. M. Engagement? You've you've I had an awareness of C. G. M. You've identified those individuals. You have applied it in the office. How do we keep it an ongoing part of their control? The person needs to feel in control of it. They need to feel a part of the shared decision that you need to match the C. G. M. And its features to the person their current needs. That's what you do. You're you're pairing it with the appropriate patient and what their desires are. You need to establish those personal and HCP goals with utilization. What do you want to get out of it right Or just want to get hypoglycemic protection that's too narrow. I have the patient journal. I say I'm gonna put a C. G. M. On you. I want you to have an awareness of how food affects you. Not a good or bad. It's like tell me what happens when you eat oatmeal, tell me what happens when you get in an argument with your wife, when you when you're caring for your elderly mother, when when you're exercising when you forget to take your Metformin at bedtime at dinner time. It's a story. It's a narrative. Bring it back in and we'll share that and I'll ask you what did you learn because you gotta download that information. You got to take that information and that data and see it from the patient's perspective and then provide your insight as a provider. So you can illuminate it. Now you need to determine whether this is going to be ongoing as a daily thing episodically or maybe intermittent use by the person. It's okay to do that. You know sometimes affordability and accessibility is overcome by doing intermittent C. G. M. Where an individual could pay cash for it in a very affordable way and accessible way and they do it intermittently. So it doesn't become a burden or whether you do get it covered and you do fight for different reasons for it to be under a personal benefit but but there there is accessible ways for this. So here are some of the codes for application and interpretation. I'm gonna go back to what I started to at the beginning this is your clinical decision and your tool and this is helping guide the patient's therapy. You should be reimbursed for it and it is highly reimbursed. You need to take these three codes. Three that's it there's only three and give them to your builder and say hey we're going to be incorporating C. G. M. I want to put these cpt codes as modifiers to my E. N. M. Codes. That means you bring them in for a visit. I don't care if it's in person or virtually you can still build for them. You have any mm visit and you do those cPT modifiers depending on what you're doing. Let's say you're putting on a personal see. Gm. Just like I told you the medical assistant putting on that C. G. M. Training them downloading the app, setting up the reader setting up the data sharing applications for later. That's a 95249 and that's done at the visit when it's placed. Okay Don't build that more than one time a month. Why? Because you know what you assume is that you're setting it up. You know you're putting on the personal if you need to repeat later because they they're not comfortable with it do that But generally we build up maybe one time maybe twice in a year. Professional C. G. M. You own it as the as the prescriber. It's a different reimbursement because you've already purchased the sensor still your medical assistant or back office staff are going to be applying it but that code 295,250. We want to make sure that you have a minimum of 72 hours. That's what Medicare says. You gotta have it on for 72 hours because you can't make decisions with that. Also don't put it on more than one time a month. Now what about when you bring them back and you interpret that data? I don't care if it's a personal C. G. M. A professional C. G. M. You just got one code to remember 95251. It doesn't matter it's interpretation code it doesn't matter what type and that is done with a minimum of 72 hour where why you need to have data 72 hours is the minimum I like to do 2 to 3 weeks and I can build this every month. All of these codes are covered. You can build these Cpt codes If you are a prescriber who is reviewing the data let's say I decided to review the C. G. M's. Today before tomorrow's appointment. I could build it as a standalone. C. P. T. I don't generally usually always pair it with the visit that way the patient knows that way I can keep track of it and that's just how I do it with my particular workflow. You gotta ask yourself who owns the equipment. How often am I doing it? What's the minimum amount of wear? Please do not neglect the downloading. You need to put it in the chart either through a dictated version, a image document. That's how I do it. As a pdf I cited. I have macros I discussed the interpretation. I say additional time was spent analyzing the A. G. P. Which can be found in the image portion of the documents. My P. A. Does a macro showing all the time in range and how it affected her decision making anybody who can prescribe C. G. M. Ken bill for C. G. M. So C. G. M. Is the future for all persons with diabetes. It is based on its utility, its clinical and scientific benefit. It provides us that continuous data that permits us for precise real time understanding. It's the new gps of diabetes. It empowers the patient and empowers you as the prescriber for all of those directional care. It helps them engage, it helps them stay safe, manage their current glyphs. E. Mia their future headings and retrospectively looking at their patterns. We have very specific recommendations through time and range targets and what we're trying to shoot for when your patients say what fletcher am I trying to get? We have emerging evidence that link lower time and range variability to increase benefit and we see that lower time and ranges has more long term complication and terribly adverse outcomes in pregnancy. It also means the ends of the painful finger sticks. I think we forget it's like a harpoon at the tip of your finger and you want to do it every day. Now. C. G. M. Really to me is painless. It's that painless way to provide more information. It is an essential tool. Once you take that first step to utilizing it and incorporating it, you're you're gonna look back and say, how did I ever live without it. It really is. It's such a unique tool that benefits the person and the health care provider. And whenever both of us benefit from that, we all end up winners in trying to take back the life that diabetes tries to steal. Thank you so much for joining today's program. I hope you found it informative as well as inspiring.
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