Nuzat, welcome, and I know you are also busy taking care of patients today, but thanks for joining us and such a great pleasure to have you here. So thank you, Vivek, and thank you to the ASG for asking me to speak today. So I am going to talk about, I have two back-to-back talks, hopefully I'll stay within the 40 minute allotted time, otherwise feel free to turn off my mic, Vivek. The first talk is about how to set up an EUS practice. So this is really a nuts and bolts talk about how to set up a new EUS practice. This is most relevant to people who are planning on setting up a practice, but I hope that those of you who have established practices will also find something useful in this. So I have no relevant financial disclosures. So essentially, whenever you start a new program, you have to go through four stages. There's the planning and strategy phase, there's implementation of the strategy, then you stop at a certain point and evaluate where your program is and where the kinks are, and then obviously you enter the maintenance phase. In my opinion, the two most important stages are the planning and strategy phase, because as someone said, measure 10 times and cut once. And the second important phase is the maintenance phase, because that is when things tend to slide back. So let's go through these one by one. So the planning and strategy, I'm sure business schools have allocated entire semesters to this, but essentially, it's the why, where, and how. Why are you starting this program? How are you going to start it? Who's going to do the work? How are you going to pay for it? How are you going to recoup your costs? And how are you going to get the word out? That's really essentially the pillars of your strategy for starting up a new EUS program, and for that matter, any other program. So let's break these down. So the first one is the program objectives. This is extremely important that you have a really good understanding of why do you want to start a new EUS program. Most commonly, it's because you are really well trained in EUS and you've just joined a practice that doesn't have EUS, or it may be that you want to train somebody within your practice to start an EUS program. But there are other reasons for starting it as well, which is you want to diversify your offerings, or you are part of a practice which has a target population that would benefit from this offering. This can include you being part of a regional cancer network, or you notice there are a lot of out-of-network referrals going out. I know that there's a program, there's a practice in Philadelphia that started a program precisely based off their out-of-network referral volume. The next one is volume, right? So you need to have a sense of what your volume will be when you start the program. Really, this is not a shot in the dark. There are surrogate markers that you can use to anticipate the volume, and these can include the number of pancreatic protocol CTs that you're doing, the MRCPs, the IOCs, how much radiology-guided biopsies are being done at your institution or in your practice. ERCP volume, if you have ERCP, because ERCP and EUS often go hand-in-hand. And then obviously, like I said, out-of-network referrals, or even within network, what referrals are you doing? What's the volume of referrals? And then if you're part of a tumor registry, you already have a patient population that you could serve by offering EUS. Now, geography matters. It matters a lot. If you have a practice in an area where you're going to be within stones through five established EUS practices, then you have to really have a rock-solid reason for starting another practice. But I'll tell you, it also depends on the population of where your practice is. So for instance, in Philadelphia, where I practice, within two miles, we have a peer academic institution with a robust advanced practice. And then within five miles, we have two other institutions. But because we're in a busy metro area, each one has enough business. So you really need to look at the population of where you're going to be opening this up, and what catchment area will you serve, and what's the competition in that area. And this is, again, it's not a one-size-fits-all. You really have to look at your own practice. And then I highly and strongly recommend a formal needs analysis, which is typically done by your business office. This is typically financially driven. And they really have the tools to look at return on investment, any downstream revenue that this will generate. Because what happens is if you have this starting out, later on when you want to go back to the hospital or the leadership and ask for more resources, you can always refer back to it. And I strongly recommend that this should be done, especially when you don't negotiate for capital costs. And then establish metrics for successful implementation. They could be anything. I mean, but there are some common themes. You want to say that you're going to increase the referral volume. You're going to look at downstream revenue. You're going to look at, for instance, breaking even. That might be your first metric. But regardless of what it is, establish it right at the beginning. Go back to these when you're evaluating the program at any point in time. And then obviously, once you have met them, this will be your negotiating card for expanded growth. So the second part of strategy is really who will be the team. You need champions and you need stakeholders. So champions are typically the GI leadership. It could be the chief or whoever the leadership is at your institution or your practice. It's typically the endocrinographer. And then you can actually lean on surgery and oncology to champion this as well, because that is the patient population that you will be serving. And they can actually really go up and speak for you on your behalf if needed. Then there are stakeholders. You need to get nursing involved because they will be nursing and or teching, depending on what the setup is at your practice. Pathology needs to be on board because they will be doing the cytoprocessing. And especially if you're going to be doing on-site cytology, then you really need to talk to them about that. You have to look at instrument reprocessing. EOS scopes are different. If you already do ERCP, then instrument reprocessing will have experience working with scopes with elevators. If not, you really need to talk to the vendors, have a formal training, and bring them on board for this change. And on the administrative side, it's typically the CFO, because they hold the purse strings. The CMO, who are very interested in new offerings, because clearly you're diversifying what you're offering to the community and to the referring physicians. And then capital costs or materials procurement. Every institution has sort of a silo that runs this. And depending on where you are, this might be under the CFO, CMO, or even within your own practice. Now, where to do EOS or set up an EOS practice. Now, when EOS started, this was hospital-based. And then it slowly moved into the outpatient hospital-based practices. And over the last five years or so, it's increasingly moved out into ASCs. And again, this is not a one-size-fits-all answer here. You really have to look at your practice and see where it will work best. And the things you have to really take into account is economics, because ASC is more cost-effective than hospital-based. Efficiency, because if you want a return on investment, you have to have a very efficient practice. And an efficient practice can only be if you are able to move volume through fairly quickly. So ASCs are traditionally more efficient than hospital-based practices. Access also, patients should be able to get in on a timely fashion. And ASCs tend to provide more access, typically, than hospital-based practices. And then if you really matter to the idea of on-site cytology, then that ASC might not be a good fit for you, because at least I don't know of any sites where there's rows in an ASC. So again, you really need to figure out what your metrics will be and what you're hoping to achieve with your program. And based on that, you will decide where you want to embrace this. Now, capital cost is the big thing. This is really the main obstacle sometimes to starting EOS. The second one is training. So the equipment, you have to buy processors, you have to buy scopes, and you have to buy accessories. There are the big three, at least in the US. And I think I can take the names, because I don't have a preference for one over the other. There are the three main processors. There's the ALOCA, which actually is compatible with scopes from all the three big industry partners. There's the Olympus EU-ME2, which is compatible only with Olympus scopes. But the plus side of this is that if you also plan on embracing endobronchial ultrasound, you can use the same processor. And then there's the Fujifilm SU-1, which is compatible with the Fujifilm scopes. So I think, essentially, you'll have industrial partners or vendors that you're already working with. And depending on that, you'll lean towards one system versus another. The next question comes up, what kind of scopes do you need? Do you need radial, linear, one, both? I'll tell you that our ratio of using linear to radial is perhaps 25 to 1. We mostly use linear, but we also use radial. And we exclusively use radial for esophageal cancer staging and for rectal cancer staging. I know other institutions where they do rectal and esophageal cancer staging with linear scopes, but we don't. We feel more comfortable with radial scopes. If you were to buy only one scope, I would say buy a linear, but ideally, you want both. How many scopes really depends on how many endoscenographers you have. If you're going to be more than one with two rooms running, then it's going to be a different number of scopes versus one endoscenographer and one room throughout the day. Expected number of procedures will play a role in this. And obviously, the scope turnover time. And one other added issue to think about when you think about the number of scopes is whether you're going to be varying your scopes between a hospital and an ASC. We are actually looking to do this at one of our hospitals. And we are thinking of increasing the scope number there just because the scopes are going to be going back and forth. You also can look at new versus refurbished scopes because refurbished scopes are cheaper. There are certain vendors that do a lease-to-own model. And obviously, for accessories, the F&A needles are cheaper than F&B, but they are pricing models and bundles for accessories. The list prices are just that. They're list prices. There's always negotiation power. And you essentially have that with the people that you work with currently. So just to give you some idea of what the capital costs for your program will be, these are list prices again. And I've just put down company one, company two, company three. These are from last year. And there's actually variation across the country as well in the list price. So and these prices are not what you'll pay, but they give you a ballpark figure. So if you look at a high-end processor with two linear and one radial scope, the cost of your program will be between $400,000 to $600,000. And that's, again, just a ballpark figure. And depending on how you finagle the number of scopes, these costs can be different. So how much work do you have to pay for all of this? So this is the 2023 Medicare National Average Payment data. And you can see here, I've highlighted this, the RVU for an EGD with an US F&A is about four RVUs. And if the RVUs for a diagnostic endoscopy around 2 to 0.1. So it's really a lot of work that you have to do. It's just a step up from an upper endoscopy. And if you look at the cost of the equipment and the training requirements that goes in, you really have to go back to your program objectives to see why you're starting this. And just as an aside, you can see over here the cost difference between having it in the hospital and an ASC. The ASC is less than half the cost of running it in a hospital outpatient. At Penn, we do it in a hospital outpatient, but it runs very, very efficiently. We schedule US F&As in half an hour slots. And if you're doing an ERCP and US F&A, we'll schedule the whole procedure in one hour. I don't think it's ideal because we almost always run over for the ERCP US F&A combined, but US F&As in practice hands, you can easily do in half an hour. So what about training? So there are variations around the country. So there are people who come out of fully advanced programs and are fully trained in EUS. And I'll tell you one thing, as somebody who does both diagnostic and therapeutic EUS, I can tell you diagnostic EUS is sometimes harder than therapeutic EUS. So the ideal is having somebody who's fully trained in a supervised setting with EUS, but you see variations. It can include like short courses. It can include just learning on the job. I recommend that if that's going to happen, you have somebody who's there to supervise the teaching. Because like I said, mistakes can happen. And especially in staging of cancers, you can really can have ramifications on patient management. So the competency, endosynographer competency, the ASGE recommends 150 supervised procedures before competence can be evaluated. And this includes 75 pancreatic capillary and 75 mucosal cancer staging. And this is, again, this is the bare minimum that you need to do before we can even evaluate how competent you are. And there was a study, actually, the references sort of slipped off the slide, which demonstrated that 150 is not enough and that you'd need to do 225 supervised for comprehensive competency assessment. And I think this is true. I see fellows routinely, we train two fellows a year, and a lot of fellows are not really ready even after a year of diagnostic EUS imaging. Now, training of staff, you have to take that into account, whether they be technicians and nurses. If you already have technicians or nurses trained in doing ERCP, then it's a very natural transition. If you don't, then it's a little bit of time. And then obviously training the reprocessing personnel, like I spoke about earlier. You have to have a conversation with your lab. If you're going to be doing cytopathology, whether on-site or off-site, it needs to be a conversation. You need to keep on going back to the board about, a drawing board about adequate cellularity, what you're doing, whether you're going through the stomach, through the duodenal wall. You really have to learn to speak the same language. What does atypia mean? And trust me, it took us a while to get there. Atypia to cytology means something different than it means to you. And again, something different to the surgeon. So this is important that you speak the same language and it takes time. Also speak to your lab, your general lab, because if you're going to be doing cyst aspirations, you'll be sending off fluid. And there can be a lot of confusion about, hey, where the heck did this fluid come from? What do you mean cyst fluid? So just let them know in advance. And if you're going to be doing molecular markers, then you need to set up a relationship with one of the commercial vendors that are out there doing molecular markers. And there's a specific workflow around that, that you need to talk to your lab about as well. But they come and train you, so that's fairly easy. So how do you spread the word once you start? So obviously you're going to spread the word to the public. If you have social media, YouTube, Twitter, obviously use that, use local media. But I think the more important implementation or spreading the word is to your colleagues, because that's where your business is going to come from. So you can do newsletters and mailers. I actually don't even know who reads those anymore, but you can try that. Medical staff meetings, lectures, and outreach, obviously. But I still think the good old-fashioned way of picking up the phone at the end of a case, calling your referring physician and saying, hey, this is what I found, this is what it looks like, is really the way to go. This is how you build up a practice when referring physicians will equate your name with a very, very high-quality EUS. So don't underestimate the power of the phone call. And then finally, the very important parts of program evaluation and maintenance. And so in order to do that, you really need to have an oversight team. Now, this doesn't need to be an expansive team. It can be you, the endocrinographer, plus one, or whatever you want, however many people you want. The ideal state would be one person who's objective and can look at it in an unbiased fashion. And they basically meet every so often to go back and see if your metrics are being met or where the kinks are, where the obstacles are, where things are falling through. I strongly recommend that you focus on quality. This is very important to really embed in your DNA when you start a new program. Adopt some quality metrics and stick to them. So for EUS, the ones that are recommended are that every cancer that you stage should be staged using an AJCC-TNM classification. And if for some reason you can't, if there's an obstruction, then use a modifier. That way, when you go back, you know that you're sticking to that one quality metric. Look at your diagnostic rates and sensitivity for malignancy in patients who are undergoing EUS FNA for pancreatic masses. This is very important. Your numbers, even though there's no real standard benchmark, but you should be over 90, 95%. Also look at the incidence of adverse events after EUS-guided FNA and make sure that you're not an outlier. And if you are, you need to go back and figure out what's going on. Go back to the metrics. And I think I recommend that if possible, you capture your metrics as structured data so that you can go back and look at it. And like I said, whatever they may be, you can set a timeline that in three months, we're going to go back and look at where we are. But try and capture that as structured data because it helps you really go back and drill down into granular details if needed. Look at the return on investment because I'm telling you somebody else is going to be looking at that. Make sure that if you're setting up this program, the equipment is just not sitting around. You're using it every day and really trying to break, even if not turning a profit. And then look at growth projections finally. You don't want to be stagnant with your EUS volume. You want it to grow. So think about how you're going to grow this program. Where are the pockets that you need to grow into? Are there new uses that you want to embrace with the EUS equipment that you have? So in conclusion, I think EUS programs have rapidly expanded across the country. I would say that when you set up a new program, detailed planning is key. Spend as much time as you need to on this. Have well-defined metrics for a successful program so that you can go back and doubt these when you are looking for more capital for growth. Adopt quality indicators because you really want to be a top-notch EUS practice. Anticipate challenges. Actually, you will have challenges. They can be because of training of personnel. You might run into capital costs. Reimbursement is always an issue. Project for growth and then always keep an eye on the landscape because we are in an environment where things change almost on a monthly, if not weekly basis. So keep an eye on what's going on around you because that can sometimes have an effect on how you're going to grow or how you're going to pivot in your EUS practice. So with that, I am going to stop. Thank you very much.

endoscopic ultrasound

EUS practice

planning and strategy

implementation

evaluation

maintenance