 Welcome to Texas Heart Institute Educational Programs featuring cardiology in the time of COVID-19 pandemic. The title of today's presentation is Digital Medicine. My name is Van Rikrazier. I'm an international cardiologist at Texas Heart Institute and CHI Health Baylor St. Luke's Medical Center. Joining me as a moderator is my associate Eduardo Hernandez. He is an international cardiologist at Texas Heart Institute and CHI Health Baylor St. Luke's Medical Center and also Medical Director Diagnostic Heart Center of St. Luke's Hospital. Our special guests today are Dr. Tony Doss and Dr. William Kahn. Dr. Doss is well known to us. He trained at Texas Heart many years ago and gained expertise in the field of endovascular interventions, particularly related to peripheral vascular interventions. He combined two great experiences, one from being trained at Harvard Medical School in medicine and also in one of the leading institutions as far as cardiology is concerned, Texas Heart Institute and used his educational experience to his best ability and became internationally known in the field of endovascular interventions and particularly in peripheral vascular disease and education in cardiology. Welcome, Tony. Zvonko, thank you very much for that kind introduction. Our other guest is Dr. William Kahn. He's a good friend of ours and cardiovascular surgeon, cardiothoracic surgeon at Texas Heart Institute for many years. He's an inventor. He's a scientist. He's an experienced cardiovascular surgeon and heart transplant surgeon as well as an innovator in cardiac devices are concerned. He's currently a vice president of Johnson & Johnson Medical Device Companies and executive director for Center for Devices Innovation at the Texas Medical Center. He's also professor of surgery at Baylor College of Medicine. Billy, welcome to our program. Thanks, Zvonko. Glad to be here and looking forward to the session. So we are experiencing great pandemic with COVID-19 and significant destruction as far as health care services are concerned. This new pandemic is causing a major impact on all the segments of our society and also in medicine, particularly related to the hospitals, different specialties, the use of our intensive care units and also our staff and equipment. It is now the time where we must change our mindset how to offer safe and better patient care considering this COVID-19 pandemic. Virtual patient visits via telemedicine exist for decades and has become a necessity during COVID-19 pandemic. Technology is rapidly evolving with new wearables and new implantable devices to offer our patient good quality of care. We have true experts in the field of telemedicine such as Donnie Doss who has pioneered many aspects of this particular way of approaching our patient care and we would like to ask Dr. Doss to give us an insight on this particular issue. One of the important things that we have to consider and this information is very important and very pertinent. A national survey in proximity was carried on on a physician's view on the coronavirus pandemic and the review of this experience from us interventional cardiologists is very meaningful and very important. Here is the information on this particular review as far as coronavirus is concerned and how we have altered our patient care and how we have implemented telemedicine technologies in our clinical practice. This pie-shaped chart shows clearly that a great majority of us have embraced this technology and are using it on a regular basis to improve our patient care. However, there is a significant segment of our cardiology community that is still not embracing and including this technology in patient care as we can see roughly 19% have not initiated yet and 28% are moving in that direction. So, Donnie, if you don't mind, can you explain to us a little bit more in detail what is digital health? That's a great question. People often take the terminology of digital health and telemedicine, artificial intelligence they sort of jumble them all into one. The bottom line is that telehealth is the overall encompassing strategy for using digital technologies to deliver health care. So digital health specifically is taking physiologic parameters that you can get when the patient is not in front of you, whether they're untethered from the office or from the hospital and those physiologic parameters may be blood pressure, weight other physiologic parameters like oxygen saturation or EKG or rhythm disturbances and putting those into the connection of their care. So digital health is really taking those pieces of information and then using them for patients. So Dr. Doss, thank you for joining us. Please tell us what's the history of digital health and what were the obstacles to its development? First, I think it's important to recognize why I think that telehealth in general has really gained such popularity because if you look over the last several years, really from about 2013 on, there's been a decrease in the overall patient loyalty. The idea that a computer or an app would take over the idea of seeing a patient instead of coming in to see you, the patients would be more likely to prefer even being seen by someone over an application. And that started being a real thing and when you ask physicians, hey, do you think that a patient is going to come in and see you or rather use an app, people would say, no, for sure I have a great relationship with my patients. But we started seeing back in 2013, 2014, that there was a migration and companies like Teladoc and others really started making a big impact. In addition to the decrease in patient loyalty, two other things were happening along the way, which is one, there was a lot of investment going into the digital space. There were multiple companies that were creating first consumer-based products and now more kind of medical-grade products which were untethering that care and getting physiologic parameters for people. Then the third thing that happened, which was part of the perfect storm, was that CMS created codes called remote physiologic monitoring codes and Medicare and the services to pay for these devices became implemented in 2019 and then improved in 2020. But in addition, the FDA also created a pathway for approval for these devices. So the decrease in patient loyalty and increase in investment of technology and then the regulators basically being involved led to all of these things being more likely to be used. The big limitation prior to COVID-19 was the site of origination of telemedicine specifically had to be another physician's office or a nursing home or a regional hospital. A rural area had to be designated to qualify for telemedicine. Those rules are all gone right now and although there is a requirement for audio and or visual communication, the originating site, at least during this pandemic, has shifted from the requirement of being in a location other than the patient's home to allowing it to be in the patient's home. And I think that's kind of changed the game completely. Now the question is how do you implement these devices and some of the technologies that companies like those that Billy works with and that we work with to really make a difference? You can see on the slides here that the wearable technology investments have gone up dramatically. In the next slide, you'll see that CMS and Medicare have also created digital health action plans over the last few years, particularly adding these codes for remote physiologic monitoring. So the combination of these changes really all occurred prior to COVID and now the site of service has immediately changed. And so now people are able to implement all of this activity that's been happening literally since 2012. So Tony, if you don't mind, can you mention to us available telemedicine programs that are HIPAA compliant? Of course, we can communicate with our patients in many different ways, but some of those programs such as FaceTime and many other ones might not be HIPAA compliant. So how do we overcome this obstacle and what is the appropriate way how to communicate in a safe, reliable and protective way with our patients? Right, so that's a super important question. First of all, many electronic health records have an embedded telemedicine program that may or may not be turned on. So we use e-clinical works, Athena, others, that private practices and others use. They already have these embedded programs and in those, they're already HIPAA compliant. There are also the ability to use things like Zoom or Skype and those are HIPAA compliant if you have a business arrangement with those companies that you agree that you're going to use them as they're intended to be used. FaceTime, as you mentioned, is not HIPAA compliant. In fact, interestingly, you may not know this if you call a patient on FaceTime, even if you block your number, they're going to see your number if it's coming from your cell phone and they also get some information about your Apple ID. Hangouts is not a HIPAA compliant. We use a variety of things. We really try to use our internal electronic health record, number one, which is ECW. If the patients can't figure out how to use that because you know the different ages of patients and different abilities, then many people have gone to a free service called DoxyMe, which is HIPAA compliant because it's only able to be accessed by physicians using their NPI numbers and their license numbers. There are a bunch. There are over 120 telemedicine products that are out there right now, and they include things like UpDocs and TeleMed and Intouch and 75 Health. The number goes on and on, but the key here is that there are many avenues for using it, and the requirement is audio and visual up until some states have gone to telephone only, and that's now become almost every state. Greg Abbott here in Texas made the declaration that telephone alone would be used at this time, and in fact, one of the most compliant organizations anywhere, which is the Veterans Administration, has also adopted the telephone-only compliance for the use of telemedicine. So I think that people are just right now scrambling to be able to communicate with the patients and to be able to make sure that they have access to their physicians and try to keep them out of hospitals. There's probably no better time than to have a reliable form, but to your question, Eduardo and Zvanko, there are over 100 plus platforms. Many of them are embedded in your EHR, and some of them are just typical things they're using like Google Duo, Zoom, and Skype, and those are HIPAA compliant if you have a business associates agreement with those companies. Can I ask you a question? What are you, what are we using, and how do you see this being implemented? Are there any obstacles or difficulties that we have encountered? So we had conversations with a few companies. Some of them were pretty expensive for small private practice groups, or I'd say private practice groups of less than 15 doctors, and are more applicable for larger enterprises like hospital systems. Doxy.me seemed to be a very simple to use platform for us. For one, it doesn't involve having an application for the patient or a download. So it simply involves the ability for the patient to download email and click on a link which automatically allows the patient just to put their name in and it shows up on your dashboard as a patient waiting on Q to be seen. So it's very easy to use as an initial startup. I did notice the issues with FaceTime because I had some patients call me back when I couldn't communicate with Doxy.me, and that's one of the issues I think a lot of these companies may be struggling with, which is how much bandwidth they have or ability to absorb all the people that are currently using them. So you do have issues at times with loss of video or loss of audio that you have to work through. And my discussion with other physicians in our vicinity is that they are also starting to use these platforms with some degree of success. And then I have other physicians that I've talked to around the country that are using just telephone as it's been approved for them just because it's easy, seamless and secure. Thank you very much for this information. So Tony, let's talk a little bit about technology that is needed or essential to initiate good quality digital communication with our patients. What is available and what are you using? So that's a really good question. I think the thing is to try to tailor the technology that exists that's out there for each individual patient. So this is the biggest limitation that we have right now is to have reliable physiologic monitors for things like heart rate, blood pressure, listening to heart sounds, et cetera. And this has evolved in relative. We have instituted a variety of different techniques including wearable technology which is essentially a watch. I'm wearing one right now and this watch can monitor and evaluate for atrial fibrillation and goes through a patient portal and a physician portal that we can tell whether the patient has atrial fibrillation or not. It's also coupled with things like a Bluetooth blood pressure cuff and a weight scale for heart failure patients. And we were really poised to be able to do this as we started this practice called Connected Cardiovascular Care back in November of 19 before any of this happened. And the goal was to enroll patients specifically that had either atrial fibrillation or heart failure or even certain forms of vascular disease where some technologies could be used to assess wounds, et cetera, into a remote monitoring program. But really that's the limitation right now is to have accurate, secure, and reliable medical grade devices that will actually give us that information. So we're working with a couple of companies right now on developing accessories to this type of system. So we have the heart rhythm issues. We have the blood pressure issues. We have the weight, but we're also working to try to create more robust digital stethoscopes that are much less expensive than what's out there right now and also potentially, there's sensors out there like rings that can monitor oxygen saturation, et cetera. And ultimately there will be some form of a suite of devices that patients will get in an office visit and they'll ultimately go home with those devices and then we'll be able to touch base with them and be able to communicate with them in an untethered way. And that's kind of where this field is going and there's a tremendous amount of technology being initiated right now. So just wait and see. I think it's going to be a lot. Dr. Cohn, you were going to mention something. Yeah, I was just going to put in a plug for our ecosystem here in Houston, Texas at the Texas Medical Center, which for those of you watching is the largest medical center in the world. But there's a big innovation facility, TMCX, which is like an incubator where companies come to have access to the Texas Medical Center and the Texas Medical Center leaders. And every six months, a new cohort comes in and the old cohort goes back to wherever they live. And so we're on the 10th group and every other group is digital health. And to echo what Tony said, the number of companies that are working on HIPAA-compliant communication tools is mind-boggling. Half of every cohort have unique solutions for that. But also the number of companies that are coming up with unique sensor modalities, ways of gathering data to give you a more complete picture than maybe you could do historically by visiting with the patient. For example, as you alluded to, having what their blood pressure and weight and cardiac rhythm. But activity over the previous week, how much did they stay in bed? How many times did they go to the refrigerator? How many times did they urinate? We have digitally intelligent toilets that monitor how often you go to the bathroom and what the volume is. So the amount of data you have to analyze the patient may become much richer with this huge wave of new sensors that are being developed that are very unobtrusive, that make the smart home that you're living in that when you log on to that patient, you now have so much more to go on than you did when they sat in the waiting room for two hours and came in and spent 15 minutes with you. And so this COVID-19 pandemic has been a horrible crisis, but it may be the enabling thing that allows us to realize that this digitally rich interactions aren't just adequate to replace the traditional approach, but may be richer and may be the new normal. So, Billy, you are on the forefront of innovation. This is your primary job at the present time, I believe, or one of the jobs, among many jobs that you have. So are there things that you might be considering, or Johnson and Johnson, many other companies considering that, for instance, leaders like Tony are desperately needing to move forward with this technology? Well, so let me be clear. I'm here as a physician and as an innovator and I'm not representing Johnson and Johnson on this conference. I can tell you, because it's public knowledge that Johnson and Johnson feels the next big age is the digital age of digitally enhanced procedures, digitally enhanced surgery, digitally enhanced patient care, and that's something that we're looking at very seriously. As you know, we just acquired the ARIS RoboBroncoscope, the robotic platform, working with Google. We have the VRB robot, so we think digital care is the next big wave. Intelligent devices, intelligent implants, and closer patient monitoring. I personally totally agree. I think Johnson and Johnson, as is usually the case, totally has it right. If you look at any specialty, there are ways to leverage new advanced sensors to enrich the information that the physician has to make a decision, and sensors have the ability to look over periods of time with multiple measurements, which is much richer than any data you would get at one instant point of care in a clinical visit. So I think the way we analyze patients and the way we leverage sensor data is going to change and usher in the new norm for taking care of our patients. Thank you. So, Dr. Doss, this is probably one of the hurdles that has limited the adoption of telemedicine and it's been reimbursement. These hurdles have suddenly been removed with the current crisis, and we expect that the hurdles will be reinstated, but hopefully not as strictly as they have been in the past. And one confusing thing for physicians has been what exactly they can do, how they implement it. You've mentioned already the combined use of video and audio as a prerequisite that maybe is being lifted right now to allow better adoption. Can you tell us about coding and billing for telemedicine? Sure. So when it comes to coding and billing, there really is essentially what you're doing now is establish patients and new patients even can be billed through telemedicine. The codes are identical, so the 99211 through 215 for level of visit for established and the 99201 to 205 for the new patient. What's different here is depending on the type of interaction that you have with them, whether it's synchronous and real-time using audio-visual from the patient's portal, in other words, your own EHR, that just adds a modifier, 95. So it's exactly the same code, but with the 95 modifier. If you're doing something that's interactive, that's not through their actual patient portal where you have an embedded electronic health record-based televisit plan, then that's a GT modifier. So that is relatively straightforward. There's also an additional set of codes which are for online digital visits. The difference between these and the other visits are that the patient has to initiate an online digital visit potentially through a question that they ask through the portal. So if a patient says, hey, I need to ask you about my blood pressure medications or I want to review something with you, it's not necessarily a full visit. And these can only be billed by the MD calling back or the NP or the physician extender calling back. The codes are slightly different. They're listed there at 99421 to 423, depending on time, 5 to 10 minutes, out to 21 to 30 minutes, depending on how long you're on the phone and whether the patient was called by the MD or by the physician extender. So those codes exist for patient-initiated questions, which you can turn into an online digital visit. The other codes are the same established or new patient codes with the additional modifiers depending on how you did your real-time audio-visual interaction. So it's relatively straightforward with these two listed out this way. I think you can probably navigate the waters right now. I think your other question was the more important one, which is we don't know the answer to is when will these change and how will they change? So once audio-visual changes or the site of service potentially goes back to someplace other than the home, which I can't imagine that's going to happen now, then I'm sure there'll be a whole new set of codes that will be implemented that will really help, hopefully, to maintain access, reduce the risk, and to continue the telemedicine as we see it. I think the cat's kind of out of the bag right now, Eduardo, for going back to where we were before. Let me just echo that. Now that I'm with Johnson & Johnson, we have a lot of meetings and to get on an airplane and fly to someplace and stay at a cheap hotel for a day for a one-hour meeting, now all these things are online like we're doing now and we're realizing, man, you give up absolutely nothing. I think it's the new normal and I think some of the changes we're seeing now will be the new normal in medicine and I think it'll supercharge the efforts of all these digital companies by lowering hurdles for them, either reimbursement or regulatory, and I think this will be a tipping point for digital health. I agree with you. Tony, let me ask you about your personal experience in implementing digital cardiology. You obviously started before the COVID-19 pandemic, so tell me, when did you start and why did you start in digital cardiology in your practice? Yeah, so as you previously mentioned, my interest was in cardiac and vascular care and I've been doing that through VIVA and educational programs like that for many years. About 2013, I started realizing that there were so many reasons why untethering of care was about to happen and it was becoming more and more obvious that patients were less willing to come in to office visits. They wanted to do things like tele-doc and other things like that. I started working with a company that had a wearable technology, the watch I just showed you, that was going to be FDA approved for a very highly sensitive and specific assessment for atrial fibrillation and since 2013, I've been working with this group to try to improve the algorithms and the process by which this could be used. So I was interested in it for a long time and ultimately after working with them for several years realized that this is where things were going and in November of 2019, I actually made the leap to just go back into a private practice out of an employed situation and launch what I would think is almost the first really dedicated private practice to cardiovascular care using digital health as one of the main cornerstones. Continuing the coronary, the vascular, all the other things that we were doing, but integrate digital into a really strong portion of the practice and that was the birth of connected cardiovascular care and so now we're working with companies that have these devices and being able to tailor them and as Billy was saying, you want to have devices that have good, solid, accurate quantifiable medical grade conditions that you can actually use, not so much data that most clinicians are basically turned off. So we have a vendor that we like for atrial fibrillation and these issues we have good ones for blood pressure and weight scales. What you see in the middle on that slide is there are now sensor technologies that will assess the heat and sensors that will tell us whether patients are developing tropic ulcers. So we have a large vascular practice and if you have a clinical condition that's cardiac there's a set of sensors that might make sense but if your vascular practice requires evaluation either through sensors like this or others, I think that's where the tailoring really becomes important. So that's what we're doing now is trying to identify reasonable accurate HIPAA compliant addressable technologies that we can use for different conditions including someone with vascular disease or someone with cardiac condition that require specific technologies and that's kind of what we started doing when we launched the practice in November. Tony, what is missing on this particular slide is a stethoscope. So are there any things on the horizon where we might be able to also have a digital stethoscope that's relative and expensive and the patient can put on the areas of interest whether it's hard or whether it's carotids or whatever else is needed. Absolutely. I think that this technology is evolving it's pretty expensive right now. You can see a couple of examples of digital stethoscopes out there that are really pretty well made. There's some less expensive ones where you can work with physicians that are maybe at the bedside or maybe a home health agency that's monitoring the patient and that's uploaded through Bluetooth or Wi-Fi. But I think ultimately what's going to need to happen is that patients will get an inexpensive relatively reliable audio based stethoscope that either the insurance companies or honestly the practices will just give to the patients for their in-between care and the price will come down on these technologies because honestly if we had the ability to listen to the heart, listen to the lungs, listen to a carotid and understand what the vascular system looked like and the patient could use sensor technology to figure that out and that could upload into their EHR we would get most of what we get in the office for sure. I think the only thing that's going to be lacking is on the vascular side at some point we're going to probably need a little bit more robust assessment of vascular chur, like for instance Pocas or point of care ultrasound things like that where we might want to get more than just a simple diagnostic. But honestly when I tell the companies that are developing these and said we don't need Ferraris right now we literally need some very simplistic devices that will be able to tell us whether the patient has valvular heart disease, whether they have problems with irregular heart rhythms, whether their breathing is right or whether they have fluid that we can listen to or they have other conditions that we would otherwise pick up in the clinic. I think that's where we've got to start not with a really high fidelity issue right now. That's one thing that could be incorporated into home health. You maybe are looking at a new technologist that is able to visit the patient at the home we have vascular devices now like a butterfly for example. It is basically a cell phone and a probe and you can do imaging and that's possibly something you could send out to the patient to visit if you want to look at pulmonary pressure or you want to assess ankle brachial index or do a limited vascular study. It's a great great point. Dr. Cohn do you have insights on that question? Yeah I just wanted to say you talk about Ferraris. One Ferrari that I just recently saw and this is another plug for our ecosystem Johnson & Johnson again I'm not here representing Johnson & Johnson but Johnson & Johnson has a series of facilities called JLabs which are very fertile incubators for startup technology to come and develop their play and have access to major medical centers and a guy here in Houston at the Houston JLabs Jason Bang has a company that is a small implantable microphone using advances in digital wizardry and digital sensors that listens to every heartbeat and determines how many of them have an S3 how many of them have an S4 it aggregates all that data puts it to the cloud and plots your course and heart failure and whether you're ready to detune and anticipate long before a weight gain or a change in lung compliance or any of those things when you look at technology like that that's where the world is headed not just wearables but implantables or even non-touch a chair furniture that has sensors in it toilets that have sensors in it as we more people are aging in place and trying not to go into the hospital that's what the future is going to be and in select patients it'll be something like the pulmonary artery sensor that's been so successful that Abbott has or implantable microphones that anticipate decompensation and heart failure and are monitoring your rhythm and sending it up to the cloud and doing big data analytics to help us take care of our patients better and these things are happening right now and as we've all been saying perhaps this COVID-19 pandemic crisis is going to accelerate those efforts because now we see how palatable and how usable health can be applied and this would be the natural extension of that and I think we will look back on this period right now as a tipping point in all that technology well this is very interesting and exciting on a little bit lighter note Billy can you move your head a little bit closer I wanted to make sure that your hair is blue and I have to congratulate you because it matches well our Texas Heart Institute background on the PowerPoint presentations so well this color is called Cooley Blue and no I have four sons as you may know and we decided solidarity to show our commitment to staying at home and not going out in public and so when the five of us stand together we look like a pack of M&M's well thank you very much I really admire all of you guys Tony I really appreciate your leadership your expertise and your willingness to work with us on our educational programs Eduardo thank you very much as well thank all of you for your very valuable contribution to the THI program on digital medicine in the time of COVID-19 and beyond now for those of you that have tuned in to this program please join us for the next program on cardiology in the COVID-19 that will be coming soon so for all of you guys that participated in this program stay healthy thank you very much can I say one more thing I also have a daughter but she didn't dye her hair because it would take too long for it to change I didn't leave you out thank you bye