Category: Videos

06 Oct 2020

Interview with Dr. Joe Rubinsztain, CEO & Co-Founder of ChronWell: “[Be] with patients in their lives, not in your office

Joe Rubinsztain, M.D is the CEO and Co-Founder at ChronWell. The company provides technology-enabled solutions such as Chronic Care Management (CCM) and Remote Physiologic Monitoring (RPM). Previously, he was the President at gMed, which was acquired by Modernizing Medicine in 2015.
In this future-oriented interview, Dr. Rubinsztain walks us through how ChronWell works and their progress during COVID-19. He provides interesting insights into how technology will play a bigger but quieter role in the future.
Watch this insightful interview (18+min) to glimpse into the future of gastroenterology.
“Taking technology from being archival into actionable technology was critical for us”
◘  What does ChronWell do?
◘  How can patients and practices engage with ChronWell?
◘  “We can marry great people with great technology”
◘  Effect of COVID-19 on ChronWell’s business
◘  We can manage three birds with one stone – 1) stay connected with technology 2) manage chronic conditions and 3) recover lost revenue
◘  Will there be a decline in telemedicine?
◘  “This is a different world”
◘  “We see technology playing a bigger role, but a much quieter role”
◘  “Think of technology as an augmentor”
◘  Connecting the dots for GI
◘  In a technology-driven future, does the role of a gastroenterologist increase or decrease?
◘  Will doctors see patients differently in the future?
◘  People who want to be more efficient want to touch lives – from one-to-many
◘  “You have to think beyond the one-to-one intervention that is limited in the scope of time or place”
◘  “You have to live with the patient in their lives, not in your office”
◘  “Influence has to happen outside the boundaries of the office itself, outside time”
◘  How can GI practices use ChronWell?
“This goes way beyond those CPT codes”



The Transcribed Interview:
Praveen Suthrum: Joe Rubinsztain, CEO of ChronWell, thank you so much for joining me today on this conversation. I’m really looking forward to learning more about your company and how you got started. But first, I wanted to welcome you.
Dr. Joe Rubinsztain: Thank you Praveen, it’s a privilege to be here and I just love your work.
Praveen Suthrum: Thank you. Let’s start Joe, by finding out why you started ChronWell? What was the underlying idea? And what prompted you to start in this line of work?
Dr. Joe Rubinsztain: I was always passionate about computers and while I was going to medical school, we had created an early-stage Electronic Health Record. We brought that to the United States, created gMed and that became very successful. And we detected toward the end of it that the market was becoming saturated and heavily regulated. And innovation did not play such a central role anymore on the EMR. But there was a lot more to innovate beyond the EMR. Taking technology from being archival into actionable technology was critical for us. And so we figured that why not take the next step and create a new iteration of the technology that has measurable results and influences people to be at their best health.
Praveen Suthrum: What is this next iteration? What does ChronWell do?
Dr. Joe Rubinsztain: ChronWell keeps patients and doctors connected well beyond the office visit. It helps patients with chronic conditions stay at their best possible health in connection with their doctors. And it allows doctors to better play in the value-based ecosystem.
Praveen Suthrum: How does the patient engage and how does the practice engage?
Dr. Joe Rubinsztain: Imagine you have a patient that attends your medical practice and has IBD. And you’ve diagnosed that IBD and you now know that patient needs to take a special diet, needs a test regime, needs to have questions answered, you need to track their weight, and you need to make sure that you’re providing guidance for how to take the medications and things like that. So, as a doctor, you’ve issued a set of orders. We can understand those orders, we can prepare an intervention plan, we can marry great people with great technology to help the patient navigate the care for IBD. And we can connect with other players in the industry to make sure that they’re receiving the right diet such as Modify Health or to measure their vital signs with connected scales and other devices. And then keep the doctor informed with very little friction. So, imagine a patient has a care navigator or a concierge per se that is helping them navigate the condition, answer the questions, measuring the results, and that is constantly keeping the doctor apprised of everything that is going on but powered by technology to make sure that no stone is unturned and that every single detail is accounted for.
Praveen Suthrum: COVID would actually have accelerated a business model such as this did that happen in what way did it influence your business?
Dr. Joe Rubinsztain: COVID was a fast accelerator for us. Doctors were really concerned. They were no longer able to see patients. Some of the elective procedures couldn’t be performed anymore and telemedicine wasn’t enough. The practice wasn’t geared to allow that patient to establish that connection. Plus the doctors needed to reactivate the revenue stream and while they lost some of it, they discovered that Medicare had already approved a set of codes that allowed for them to take care of chronic patients. You could essentially manage three birds with one stone – you could stay connected using technology, you could manage chronic conditions, and at the same time, you could recover some of the lost revenue.
Praveen Suthrum: A lot of practices feel that COVID is going to now come and go and then in the post-COVID period we’re all going to revert back to an older form of care so, there’s going to be a decline in telemedicine. I’d wonder you know what you would say to something like that?
Dr. Joe Rubinsztain: The world has changed and in some areas, this has changed and become a little bit more divisive but in other areas, it has changed for good. Patients no longer fear interacting with doctors over remote platforms. Technology has already become our main lifeline of communication more than person to person. Social distancing is going to prevail until not only do we have a vaccine, but we have distributed that vaccine and we’ve developed herd immunity and who knows if we’re going to get another mutation. This is a different world and it has definitely changed.
Praveen Suthrum: Very interesting. Let’s fast forward the conversation to a point of time in the future. So, what role do you see technology playing in GI in healthcare and for a business like yours?
Dr. Joe Rubinsztain: We see technology playing a much bigger role but a much quieter role. Right now we as consumers are full of noise every day. We have social media platforms that push a lot of information to us a fraction of it could be useful a lot of it is ads. But what if you could have some technology that is really analyzing on the back end those things that matter to you and are able to generate an adequate intervention without getting too deep or disruptive into your life. For example, you already have smartphones and you do texting and doctors already have EMRs. Imagine if you had a very smart brain on the back end that is constantly churning information from previous claims or information from other EMRs, laboratory values, social media trends with permissions and within the boundaries of the law. Imagine that we now understand also the patient’s environments and social-economic factors and behavioral parameters. And you turn all that into an AI model or into a machine learning model that can come up with the right interventions for that patient in a personalized way.
So, personalized medicine is not just a genetic analysis it’s also a behavioral analysis. If you put all that together and if you have a very smart brain on the back end that is connected with people who are well trained and capable of empathizing with a patient, you can really deliver a great experience. It’s going to utilize some of the things that you already use such as texting and maybe social media and other communication channels to drive positive influence to help you become better. To help doctors consume a lot of information in very little time so that they can make the best decisions possible. Because those decisions were well-curated and summarized from multiple angles that only a machine can do. And so think of technology as an augmenter that is not constantly in your face but on the back end constantly analyzing and feeding you the relevant information that allows you as a doctor to be more effective, to be very efficient, and to not have to work too much and make those little changes in the patient that truly have a difference with respect to their outcomes and the cost of care.
Praveen Suthrum: I love your response on this. Help us understand from a gastroenterology standpoint if you can connect these dots for GI in particular. What does the future look like from you know this lens that you’re seeing?
Dr. Joe Rubinsztain: Imagine that you now have the ability to not only take information from a company like Echosens who is great at diagnosing the liver non-intrusively or non-invasively. And imagine that you can now compile also laboratory data, socio-economic data, and you then partner with a company like Modify Health to deliver a diet. And then you deliver an internet-connected scale that all feeds into a central database that analyzes trends, and analyzes the patients and suggests, for example, the message that is the most effective for this person to deliver. And instead of having that message at first being delivered by a human, you send a text.
Now you’re measuring how that patient actually took that info. And if that info didn’t nudge the scale, then you now have a person that picks up the phone, that has been very well trained, and has consumed very quickly the information necessary to help that patient nudge along. If that still doesn’t move the needle imagine now that we’ve generated a report for that patient automatically, that goes in, to the provider, who is very friendly with respect to the risk of that patient not following diets or potentially not moving in the right direction. So, that the doctor can make the right medical decisions and then we can go again through that cycle of the computer in the back end generating the interventional strategies, interpreting the data, and coming up with actionable items that are well distributed between the automatic side of the story, and the assistant side of the story, and the provider side of the story. And if you really know how to distribute those, you can make changes at a low cost that are going to have a big impact on the cost of care. So, that’s one example.
The example gets much more interesting when you’re going to IBD. IBD has a very complex outcomes framework. We’re working uh very hard into building a very intelligent outcomes framework in our platform that takes information from multiple sources. Not just from laboratories or EHRs but other data as well. That allows us to truly use for example machine learning to understand the difference in interventional patterns or the difference in behaviors that happen when you do an A/B test of two different types of approaches. And see if that patient actually had in the right direction or if you can use AI or you know neural network analysis to understand early trends for complications can you intervene sooner? That technology is only working transparently on the back end in only sending the signals that make sense and through channels you already know. So, you don’t have to download apps, you don’t have to install new systems, you can just come into the physician practice and with very little friction, you can tell them – “look, we’re going to work together. Give us a plan we’ll take it from there. We’ll consume it. We will send you regular reports into your EMR; you don’t even have to learn new technology. And MR. Patient, you don’t have to download our app. You’re welcome to. It’s great, it’s very useful but if you don’t want it, we’re capable of communicating with you through several channels.”
In the end, as you start looking deeper and deeper and deeper into all these chronic conditions and you start coming out with outcomes frameworks, interventional patterns, best practices, data-driven behavioral analysis, A/B tests, and machine learning that comes together into – “hey what do I need to tell this nurse to tell the patient in order to have the maximum possibility of them getting better?” That’s when it gets really interesting.
Praveen Suthrum: Excellent. So, in this world, Joe would the role of a gastroenterologist in these conditions, let’s take those two specific examples that you narrated, and it was fantastic to listen to you frame it the way you did. So, in that world would the role of a gastroenterologist increase or decrease?
Dr. Joe Rubinsztain: It increases. Look, we as physicians have been trained to care for patients. Along the way, we discovered that we needed to do a lot of regulatory work, and a lot of documentation work, and administrative work. And we needed to cater for the fee-for-service crowd, and we needed to spend less time with patients. And you know the practice of medicine quickly became the business of medicine. And a lot of people had that conflict of you know ‘What did I train for? To help or to or to be just a worker?’ Imagine if you very intelligently took a lot of that administrative work and regulatory compliance and put it into an automated process. And you could treat patients more with less time. You could make those interventional changes that make the biggest difference.
There are two things that could happen there – one is you can see more patients in less time because you had to use a lot less time interpreting information. You can look at it distilled. And the second thing that would happen is that you would have technology that augments you. That allows you to click a button and connect with a patient without really having to be synchronous. It can be asynchronous communications. Or you can have a well-trained nurse that really knows how to work together with you, who is certainly following your treatment patterns because technology understands your treatment patterns and she’s constantly monitored to make sure they comply with the treatment patterns that you’ve set. And you can take a look at everything that they’ve done.
Praveen Suthrum: You know when I interact with physicians and gastroenterologists in particular, and I take a step back and observe these interactions, a lot of the doctors are thinking – ‘If I become a technologist also or move a little bit into that world then I don’t touch lives one-on-one, I touch lives one-to-many.’ So, I’m just wondering is the healthcare world in transition? So, in the future would there be a hybrid model between private practice hospitals and a completely new world where doctors are seeing patients but just differently, not how they see today?
Dr. Joe Rubinsztain:  That’s a great question. Yes, there are some of us who like to touch more people with less effort and we’re focused on efficiency. But there are also people that thrive on connecting with others and helping others one-on-one. I don’t think there is one answer to that question. I think that people that want to be very efficient and build a great business, and a great practice can and they need technology to do that. But also there are people that want to connect with their patients and want to help them the most and want to prove that they’ve made a difference in their life and they also need to use technology there. So, either way, technology is going to help them achieve that goal. The interesting thing is that we’re going to be shifting from a fee-for-service to a value-based model who knows when but it’s certainly slowly moving in that direction. And in that case, you just don’t have a choice. You have to think beyond the one-on-one intervention that’s limited in the scope of time or place. You have to live with the patient in their lives, not in your office. Influence has to happen outside the boundaries of the office itself and outside the boundaries of time. And the only way to erase time is to automate the burden.
Praveen Suthrum: Brilliant. So, how exactly can GI practices use ChronWell today?
Dr. Joe Rubinsztain: You would contact us. You would contact our sales team. We would make a presentation for you. It’s funny because when we talk to a practice we basically tell them – “Look you need to do very little we’re going to be working with your EHR. So, it’s embedded in your workflow and then we tell them, and oh, by the way, we will collaborate with you on chronic care management and you don’t have to invest anything. We will come in and we will build this new revenue line with you and we will partner on it. And this initiative requires very little work and it requires no capital investment on your side.” And so it’s easy for them to come back, talk to our sales team, we go through the process. It’s much easier than selling an EHR for sure. And as they get deeper and deeper into the program they discover that it has many dimensions that they didn’t think of, and they start collaborating more and more in understanding a broader outcomes framework than just the interactivity perspective of it.
Praveen Suthrum: So, how do they get paid?
Dr. Joe Rubinsztain:  So, Medicare has already approved a set of CPT codes that are related to chronic care management, principal care management, and remote physiological monitoring. And some private payors are already joining in the fray. Essentially what happens is that we partner with the practices, once the patient is a good candidate for it, they notify us. We work with the patients to make sure that the program is a good match for them. And we report to the practice the activities that we’ve performed. The practice invoices the activities and pays a subcontractor fee for those services.
Praveen Suthrum: Was there anything else that you wish to share before we close?
Dr. Joe Rubinsztain: We need to start thinking differently about how we interact with patients. We know we’re busy as providers seeing, many patients over and over every day or doing many procedures over and over. It is true that some of these procedures are going to be disrupted with DNA technologies and the like. And the sources of revenue for the provider are going to change over time. In any iteration of that change, a deeper relationship with the patient is going to be critical. And a better relationship with the payor is going to be critical. And payors only want two things – They want to know you’ve delivered great care and that they didn’t pay too much for it, right? And patients only want to know of one thing that they trust you to make them better. The only way to do that is to truly be in touch with them. So, think of the experience beyond the fee-for-service and beyond your practice as a full experience, not a limited experience. This goes way beyond those CPT codes. And it goes into the new model of healthcare which is much more pervasive than an interaction that you get paid for.
Praveen Suthrum: Joe, thank you so much for sharing all your views. It was a very educational experience for me and I’m sure everybody who’s watching this will feel the same.
Dr. Joe Rubinsztain: Thank you, Praveen. It was my privilege. Your questions were great and I’m glad to be working again with the GI community. It’s a privilege.
Praveen Suthrum: Thank you.



By Praveen Suthrum, President & Co-Founder, NextServices. 

COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
22 Sep 2020

Interview with Dr. John Allen (Michigan): “[Expect] pretty stiff headwinds for many years to come”

John Allen, M.D is the Chief Clinical Officer of the University of Michigan Medical Group and is also on the board of Allina Health. In 2019, AGA presented its highest honor, the Julius Friedenwald Medal for his contributions to gastroenterology. Previously, he was the chief of Digestive Diseases at Yale and helped build Minnesota Gastroenterology (now MNGI), one of the largest GI practices in the country.
This interview is so insightful that it’ll help you make several business and personal decisions for the long haul. Here’s specifically what you’ll take away:
1)  What does it take to lead calmly and steadily through a crisis? Especially a large health system like Michigan
2)  Planning for another pandemic (or another wave) should it occur
3)  Fundamental shifts in GI and US healthcare economics that we are not yet recognizing
4)  Weighing pros and cons of private equity
5)  Future of gastroenterology – technology, consolidation, ethics and morals
Watch this thought-provoking interview (45+min).
Do not miss this one – watch it end to end.
◘  Dr. Allen’s professional journey so far
◘  The complexity of handling COVID in a large health system: “It was brutal”
◘ “We were mandated to reduce costs by $400M (laying off over 500 people)”
◘  As a leader, how to navigate emotions and views calmly?
“This is a time to come together and show the most empathy we can”
“This is the chronic phase. We’ll have to adapt our care to exist with this monster virus”
◘  Are you planning for another pandemic?
◘  How do you disseminate learnings from the large system level to smaller practices?
“When you have high fixed costs, it’s like 80% of your home mortgaged”
“We are going to see Medicaid enrollees go up from 70 million to 80 million”
◘  “At Michigan, every 1% switch from commercial to government payors is $8 million less in revenue for the same service. Multiply that with what’s coming up with the payor-mix shift.”
◘  “[Expect] pretty stiff headwinds for many years to come”
◘  What’s the future of gastroenterology?
◘  Risks of private equity
◘  How do you put checks and balances in a way that doesn’t hurt patient care?
“Academic centers that don’t morph into a true integrated healthcare systems are going to have a tough time”
◘  “You aren’t going to be able to fight Humanas, CVSes, Aetnas, Optums in primary care”
◘  How do you re-imagine healthcare truly into a force for good? (“inequities are intolerable, immoral, and unethical”)
◘  The future of GI has to reflect that (“We have to re-establish our credentials as physicians”)
◘  “At some point, we have to level the playing field. We have an obligation to take care of people”
“It’s a time of reflection, a pandemic that hits like this really brings out how weak our safety net in this country was. A lot of people are interested in changing that”


The Transcribed Interview:
Praveen Suthrum: Dr. John Allen, I welcome you to our conversation. Thank you so much for joining me today.
Dr. John Allen: Well, thank you very much. I appreciate it.
Praveen Suthrum: So, I want to begin by asking you Dr. Allen, on what your role entails in a large system as Michigan Medicine?
Dr. John Allen: Let me give a little background on my journey first. I’m a trained gastroenterologist obviously and I think I’ve worked in almost every practice setting there is from the VA to a hospital setting to a small practice to a mega practice which was Minnesota Gastroenterology and now to academic healthcare systems first at Yale as Clinical Chief there and now at Michigan first as Clinical Chief of gastroenterology and now as Chief Clinical Officer and I also sit on the board of directors and chair the quality and population health committee for Allina Health which is a large integrated healthcare system in Minnesota. I’ve gained a lot of perspective on academics non-academics and other aspects of GI practice which has been really quite interesting. And so now I go back and forth between Michigan and Allina and can compare a non-academic, consumer-oriented healthcare system with an academic system like Michigan. It’s fascinating.
What I actually do at Michigan. So, I’m the Chief Clinical Officer of the University of Michigan medical group. And so that entails all of the faculty and all of the professionals that basically bill. All of those revenues come up through the UMMG – the medical group. We also manage the facilities for all ambulatory services. We have 40 different clinical sites. We have radiology, pathology, laboratory services, outpatient ORs. We have about 23 ambulatory ORs and an equal number of ambulatory endoscopy centers. And all those roll up to the executive leadership, which is the person I report to Dr. Mulholland who was the ex-chief of surgery and he’s the executive director and I’m the Chief Clinical Officer. I work directly with the Chief Operating Officer and Chief Nursing Officer. So, we basically manage the operations of the ambulatory part of Michigan. What’s interesting is that Michigan Medicine and Allina Health are about the same size. About 4.3 to 4.4 billion dollars in annual revenue. And so, again it’s really quite interesting to go back and forth between those two systems.
Praveen Suthrum: So, on a day-to-day basis what does your role look like is it more clinical, or is it more on the business side of medicine?
Dr. John Allen: No it’s completely administration now. I stopped scoping last September, a year ago, and have been staffing fellows clinics and things like that. But it’s really completely administration. So, I’ve switched into the administrative role completely. And on a day-to-day basis like for example this week we’re figuring out where, how often, and how to give flu vaccines to the 230,000 patients that are within our primary care catchment. And how to deliver those, and safely within COVID and social distancing and things like that. So, the operations of the clinics are our main focus. And I directly oversee 22 physician leaders and then they oversee another probably 60 physician leaders paired with administrative and nursing leaders as well. So, it’s basically that type of day-to-day activity.
Praveen Suthrum: Which world is more fun? The clinical side or the administrative side of medicine?
Dr. John Allen: They’re both fun. I practiced for 40 years and at that point, I felt I had completed that phase of my life and I was fine getting out of direct clinical care. When I was 50 actually I went back and got my MBA. Got into the business side of medicine and health economics and payors and negotiation and organization. And I find that just fascinating and in some ways, you can really make an impact on many people. When you’re providing clinical care it’s really one on one whereas if you’re really doing an administration coming from a patient-centric viewpoint you can really make a difference in terms of how we deliver care in a lot of people’s lives.
Praveen Suthrum:  Was that transition easy for you moving over from the clinical side to the administrative side?
Dr. John Allen: Well it was slow and iterative. It was not sudden. I started out at Minnesota Gastroenterology in the mid-90s and got into a leadership position there in the late 90s and began to take on more of an administrative role and it was a learning process. This is not easy and it’s not something you can learn from a book. It’s learning by experience and sitting through innumerable meetings and having to deal with all the different aspects of practice, in different practice settings. So, it’s a slow process. But, you know, I’m now toward the end of my career and you know I’ve gained a lot of knowledge there and so it’s a lot easier to make those kinds of system connections and I find that very interesting. So, it was a long process, a long learning process basically.
Praveen Suthrum: Even though we are several months into COVID now you know, I want to revisit the complexity of handling COVID you know in a system like Michigan. There were several months that you spent in handling it doing different things as its leader. So, I want to ask you how was it? How did you go about you and your team how did you go about handling the situation you know in the health system?
Dr. John Allen: Well, I mean frankly it was brutal. It’s brutal for the entire world it’s brutal for Americans and it’s brutal for healthcare workers. As you know January 20th was the first diagnosis of COVID in the United States in Seattle. In early March basically, we began to shut down elected procedures. And so, we had to shut down an ambulatory operation that sees two and a half million people a year (visits a year) within literally 72 to 96 hours. So, we had to consolidate clinics, we had to figure out what patients could have deferred care, what patients needed to come in still for an emergency, how to handle them. Everybody was short of personal protective equipment. So, it was a disaster frankly for a while. But the way we handled it in Michigan was very rapidly ramp up our infrastructure which had been there before. So, we have tiered huddles that started the unit and go all the way up to the health system in the first two hours of every day. So, we developed a command center that handled every aspect of the healthcare system. Met twice a day with the top-most leaders and the frontline workers as well. And really managed it that way in terms of communication.
We instantly converted many of the rooms in the hospital into a respiratory isolation floor with negative pressure. We got to the point where we could turn a hospital room into a negative pressure room in four hours. And we expanded in anticipation of hospitalizations, intensive care units, ventilators, and ECMO. So, we had to create an admitting officer the day that had complete control over transfers, and admissions. He was a transplant surgeon who was just superb. We identified two ex-military physicians to develop plans for a field hospital. So, we were ready to open up a 500-bed field hospital in the Michigan indoor tennis courts basically. So, we had all of these things and it really showed just the phenomenal preparation for the unknown that we had here. And I’m sure other systems had the same thing. But it was just incredible, the infrastructure that we could and the expertise that we could rely on to ramp up that quickly.
So, we basically ramped down and over the first three and a half months we obviously closed down elective procedures and ended up going from a projected operating margin of 175 million dollars per year to a little bit over 300 million dollar loss just in that period of time. And interestingly, the ramping back up has been even more difficult with the unknowns that we’re dealing with, and with all the different clinical service lines that had to go from a consolidated delivery to expanded delivery.
So, it’s just been really challenging. The second or third week of the ramp down the regents of the university and the financial people at the university level basically mandated that we reduce costs on a long-term basis by 400 million dollars. Reflecting an anticipated 300 million dollar loss plus the 100 million dollars that we send to the medical school each year we had to buffer that. Reduction in overhead basically. Which of course means personnel. So, we had to go through a very complex system of reduction in force and ended up laying off over 500 people in selected areas much less in direct patient care and more in support and administration. That on top of the COVID itself and what we’re having to do in terms of our own family was just emotionally brutal.
Praveen Suthrum: A large system like Michigan is like a mini-country. Wide variety of opinions, a lot of diversity, and many emotions that you have to navigate. Not just yours or your immediate team, but of staff, of patients at different levels. How did you go about handling all that as a leader?
Dr. John Allen: Well as a leader you don’t do it by yourself obviously. You have a lot of people around. Before 2019 we did not have the structured leadership, the infrastructure that we have now. It was very thin. So, Dr. Mulholland and I and our administrative and nursing partners have basically hired an infrastructure for leadership, tiered leadership over the last year and a half and that had nothing to do with COVID but had we not had that it would have been a disaster. So, from our standpoint as the top leadership, we have to convey a sense of calm and planning to that next layer of leadership. And also teach them how to convey that to the next layer of leadership down and then the frontline staff. But the anxiety about catching COVID, the anxiety about what to do with family, and now with schools being virtual and how do you handle home-care has been very tough.
But as a leader you just you have to not react. You have to not react from an emotional standpoint and really try to empathize and understand what other people are going through when you get those brutal emails in the middle of the night, and you basically have to learn to live with that, step back, take a couple of deep breaths, and then engage them as best you can.
We’ve been going around to the departments and answering questions from faculty, and then from staff that are you know, really quite angry and upset. Sometimes there are no answers. I mean we’re having a terrible problem hiring at the medical assistant level or the call center level for a lot of different reasons, it’s a low-paying job, and it’s very difficult to hire. So, our call centers right now are really in difficult shape. And we get emails daily about you know what are you doing about this and you just really have to present the calmest face that you can and keep trying to think through this and anticipate what’s needed.
Praveen Suthrum: At an individual level what steps do you take on a daily basis or what your routine looks like that helps you present yourself calmly as a leader to your staff and patients and the wider community?
Dr. John Allen:  Well, you have to realize that you’re on 24/7. You just cannot let down. So, the first thing is those of us in administration or in non-clinical areas, the President of the university basically said do not come on campus and don’t come on campus until the end of the year. So, I’m actually in Minnesota and I’m managing Michigan. Minnesota is my home I’ve been commuting back and forth for many years, but you know I came home to Minnesota and it’s basically eight-plus hours of zoom conferencing and managing. But it’s really a day-to-day interaction, making sure that you’re touching base with the correct people, reassuring them that they have your back or you have their back, and going on like that. So, it’s completely changed how we manage them. Most of the top leaders that again don’t have day-to-day staff interactions or face-to-face interactions are working remotely and that’s really changed things a lot. We expect to continue that well into the first quarter of the next year.
From myself personally, daily exercise, making sure I get some sleep, taking care of myself and family my kids are grown so, it’s my wife and our three dogs. Basically, you know focusing on what we need is a foundation and then again being able to project that to other people and trying to help them. This is a time when we have to come together and show the most empathy we can and a giving spirit and the more you can do that, really the better it feels internally.
Praveen Suthrum: Thank you for sharing that. I want to go back to a point that you made earlier about last week or this week you know where you are discussing internally about how do you administer 200,000 plus flu vaccines across the board in the system. I’m interested to know what kind of tools do you use? How do you go about making these decisions? How do you ensure that it gets done? What kind of a rhythm or project planning do you have in place that you see it rolls out in the coming weeks and months?
Dr. John Allen: We have a really incredible Chief Operating Officer and Chief Nursing Officer. We have project managers assigned specifically to this. Flu is very interesting. We manage the same problems every year. If you look at flu vaccinations from a straight revenue standpoint it’s really a money-losing operation. We get about three dollars in net revenue for administering a flu vaccine but that doesn’t really count all the back stuff that you have to do to prepare it. So, it’s really you know not something that you make revenue off of. However, it is an incredible emotional tie for primary care and their patients they really want to provide this to their patients. So, we have tried to say you know utilize Walgreens, CVS, and retail pharmacies to administer flu. And we have gotten pushback – they don’t administer flu for kids under eight for example so our pediatricians absolutely insist on providing that. So, then what you say is how do you do that and socially distance.
You can’t have a lot of people coming in for just flu shots to our big clinics because that literally takes the place of somebody that’s coming in for you know, care of their diabetes or hypertension because of social distancing, because of PPE restrictions. So, then we’ve popped up tents which we of course did for COVID but you know come November or October that’s not a viable option in Michigan. So, we’re now scrambling to find other areas where we can administer flu vaccines and testing in an indoor basis. And you’d be surprised at the pushback from a lot of landlords they simply don’t want that there. So, it’s been a real challenge we have people scanning the facilities that are available in our county and state to try to identify this. But it’s a process of identifying facilities, identifying staff, and identifying the cadence of bringing people in the midst of COVID that has been challenging but really incredibly interesting. And we will succeed that’s the other thing we will make it happen and I’m quite confident with that.
Praveen Suthrum: In which wave of COVID are we in? You know are we still in the first wave? Have we rolled into the second or you know is this an ongoing thing? The reason I’m asking is how do you account for it internally, when you have internal planning meetings saying are you expecting things to return? I’m curious to know about your planning process actually.
Dr. John Allen:  Sure yeah it’s really fascinating. Well first of all the wave that we’re in now whether it’s the first or second wave or whatever this is the chronic phase. This is the wave where we have to adapt our lives and adapt our care to exist with this monster virus for quite some time. Whether we get a vaccine in the next month or two, there won’t be mass vaccinations, and there won’t be enough immunity within the community to really dampen this down for a long time. I mean we’re really anticipating a year to 18 months. That being said when COVID first hit, nobody knew what to do. We didn’t quite know what personal protective equipment we needed, we didn’t have enough supplies, we didn’t really know about the aerosol transmission, and the importance of crowds and masking and all of that.
So, that initial wave hit us very hard. A lot of times it hit vulnerable people like nursing homes or people in some sort of community living. Those are vulnerable people with multiple co-morbidities and they got very sick. So, they had to be hospitalized, they had to have ICU beds, they had to have ventilators, a few had to have ECMO. And the death rate was just incredible. Now the increase in COVID is in people that don’t necessarily need those you know end-stage resources. It’s more in young people who don’t get quite as sick they obviously do get sick but the demand for beds, ICUs, and ventilators is not as much.
That being said we’ve got a four-tier program depending on the wave of COVID. You get about a two-week notice when COVID infection starts and when the need for hospitalizations occur. So, we are ready at a moment’s notice to reconvert rooms that we sent back to general medicine and surgery. We have everything ready depending on what COVID is in the community. We can predict incredibly accurately how many beds are needed what ICU beds are needed. So, we’re ready for that. And it turns out that there’s a big difference between summer and winter because negative pressure rooms require incredible demand on your HVAC system. So, in summer where you’re running air conditioning and you add negative pressure rooms, you are limited with the number that you can do because of your HVAC requirements. In winter that’s a little bit different. So, we actually have seasonally targeted plans for expansion to 15 beds to 30 beds to 60 beds. And of course, we always have the field hospital in our back pocket. I don’t see that happening. And in fact, we’re learning to live with this, and we do not anticipate ramping down ambulatory care at all. No matter what happens in the community. And I think we’ll see isolated hot spots that come up you know, around parties, or sororities or things like that but I don’t think we’re going to see the mass that we did originally frankly. But we’re not going to ramp down ambulatory short of an executive order from the governor.
Praveen Suthrum: In your internal discussions are you planning for another pandemic? You know not COVID but in the future, in case something else strikes?
Dr. John Allen:  Some of it depends on the infection routes for example Ebola is quite different from an aerosolized route like Influenza and COVID. But we went through Ebola planning and we did all the things necessary in case Ebola hit. We went through for MERS and SARS and things like that. And obviously, we did this through COVID. We’ve documented everything, we have a very specific playbook that we could activate really on a dime. So, whatever hits and whatever in infection source that pandemic rests on, we would be ready for it because we’ve done this kind of planning.
Praveen Suthrum: Now you’ve held, and continued to hold leadership roles in societies and which are at the national level. What kind of learning can you take from what you already do at the large health systems and enable that and what kind of learning can be disseminated to the smaller practices you know that are spread across the country who may not have the kind of resources that you may have at Michigan?
Dr. John Allen:  It’s a really interesting question and it particularly hits gastroenterology and some it relates to the history of gastroenterology. Traditionally in the late 70s and early 80s, you had small practices or solo practices where a gastroenterologist would have a clinic and then go to the hospital to use their equipment to scope. So, those practices had a very low fixed overhead, right? They’re asset-based, that they needed to support was relatively small. In the mid-early 80s, leaders like Gene Overholt and Cecil Chally, and Mike Weinstein realized that we could develop ambulatory endoscopy centers. Then it became infusion centers, and anesthesia, and radiology. And we were able to do that to provide a much better patient experience, much cheaper. But the downside of that is it put a tremendously high fixed cost within practices. Obviously, you know this you’re a Ross School of Business graduate. So, when you have those high fixed costs it’s like having a mortgage, where 80 percent of your home is mortgaged. If you have a down-turning monthly cash flow it can be annihilating and that’s what’s happened during COVID.
Practices depend on monthly cash flow from colonoscopy and seeing patients and when that’s cut off, you have to turn around and say ‘where’s my capital coming from?’ and there are only a limited number of capital sources – you can borrow from the bank, you can connect with a health system that has deep pockets, you can connect with a private equity group, or you can connect with a strategic partner like Physicians Endoscopy for example or Optum. You need somebody that can carry cash year to year which practices don’t do because of tax consequences. So, practices now are in the position where their cash flow is devastated and they need capital infusion. And so we’re seeing a tremendous shift in practices with consolidation, with sales to private equity, with sales to health systems all you know all based on the fact that the monthly cash flow due to COVID has stopped and the fact that the median age of gastroenterologists like a lot of other specialists is pretty high, it’s in the high 50s. So, there are a lot of people that are approaching retirement and saying “I’m out this is too much.” So, those things are going to really change the face of GI coming up.
And that’s not even thinking about the economic impact on the United States. We’re going to see Medicaid rolls go from about 70 million to over 80 million which is going to stress state budgets like we have not seen ever. We’re going to have a lot of people out of work and of course, half the country gets insurance by their employer. So, even if the economy recovers fairly well on a day-to-day basis or the equity markets recover that infrastructure is going to drive patients into either government payors or being uninsured. And that for a health system or practice is a real problem that we’re not going to see resolution for two or three years. At Michigan, every one percent switch from commercial to government payors is eight million dollars less in revenue for doing the same service. So, you multiply that times what’s coming up in terms of the payor mix shift that’s going to be really difficult to handle frankly.
Praveen Suthrum: Yeah it’s going to be a very complicated and interesting problem to solve. You know one thing that I wonder about you know, the big entities and the small entities not just in medicine but you know, we saw through COVID that large companies which we would have never thought you know would file for Chapter 11 file like Hertz or J. C. Penney or and there was an ophthalmology private equity platform that also filed for Chapter 11. So, there must be some determining factor here that might drive this. Though, I agree with what you’re saying that the smaller practices for them to handle the impact is more difficult than for larger entities which may have a cash position like you know they may have money in the bank more than smaller practices do. But I’m wondering if you know even a large entity is safe anymore and I’m talking purely from an economic standpoint.
Dr. John Allen: I don’t think it is without changing their business practice and I’m particularly worried about academic centers that have very high fixed overhead and are much less efficient than non-academic health systems for example. It is very difficult to turn the ship in a big academic center like this. You know, typically health systems carry anywhere from 230 to 290 days cash on hand that’s their bank account, right? Well, that has really diminished. If you look at the annual revenue for an organization like ours it’s about 11 million dollars so everyday cash on hand times 11 million dollars is what we have in the piggy bank.
And most of that is in liquid money but a lot of the endowments, a lot of the cash that we have, is in illiquid funds or it’s in dedicated funds for professorships or things like that. So, again from a cash flow problem, it becomes really acute. So, we’ve really had to scale back. We’ve canceled planned facility expansion of two very big multi-specialty clinics, we’ve delayed a planned new hospital build and those all have ramifications. We have you know, canceled the retirement match for all the clinical faculty for example. The leadership has taken pay cuts and I mean those are temporary things to help in cash flow but they’re not sustainable. And I still don’t think that we have fully appreciated the change in economics for the United States in healthcare because of things that I talked about a few moments ago so this is going to be pretty stiff headwinds for many years to come
Praveen Suthrum: So, that naturally takes us to my next question which is on the future of gastroenterology and healthcare in general actually. And I want to thank you first for giving a testimonial for my book Scope Forward which is on the future of GI. My question is you know what aspects of the book resonated you know, with you like what do you think is likely to happen and what then? And in your own view what is the future of gastroenterology?
Dr. John Allen: So, I appreciate both of your books actually and the Scope Forward book was very good and the things that resonated with me is your continued warning about being dependent on a single service line which is screening colonoscopy and surveillance colonoscopy. And you know we’re seeing the results of that in COVID as well, right? You perceived very well the increased dependence on technology at many levels. Whether it’s remote patient monitoring, artificial intelligence, and screening colonoscopy, all the different types of programs like SonarMD to monitor inflammatory bowel disease patients. There will be more and more of that. And we’re going to separate and I think you were right on that. And the danger of that is that those all cost practices. And the ability to handle what’s going to become routine gastroenterology or cardiology or neurology care it’s going to be more and more expensive and regulations as well.
Those expenses have reached a point in a small practice or medium-sized practices for sure that are really tough. If you’re a very small practice in a rural community, for example, I actually think you’re in pretty good shape because your overhead is low and you have a patient base that is dedicated to you and the ability to hand to deliver really high-quality GI care. I think we’ll continue with that model. We’re seeing consolidation and it’s sort of that middle spot where you have a mid-sized practice that is going to be really stressed to have the capital to handle these innovations. And I think you hit that really well in your book. You also have a lot of emphasis on private equity, both in your first book and some in this book as well. And I’d just like to speak a moment if you wouldn’t mind about some of the risks that I see in private equity.
The basic business model of private equity is to do a leveraged buyout where you basically accumulate whatever you’re accumulating, whether it’s a manufacturing plant or a practice. Strip out costs as best you can consolidate to achieve some sort of economies of scale but you have to hit about a 20 percent annual return and correct me if I’m wrong but you know if you’re an investor in a private equity company you expect that it’s high risk but otherwise you just put your com your money in mutual funds. You expect that kind of annual return. And private equity goes in with the cash influx at first, which is good if you’re a more senior partner and you know are thinking about retiring in the next few years. But it’s really that second bite when the private equity sells to a bigger private equity where the second cash infusion comes in, where you get that much of a return. Because in between that you’re basically discounting your salary because you’re investing in the private equity whether it’s a management company or whatever it is. So, it’s a little bit tough, and private equity does not come in to really improve healthcare as their primary goal. You know, they are very much in it for profit.
A side effect can be better patient care, accumulation of big data, things like negotiating power. But I’m skeptical that this is going to really play out and maybe a repeat of the 1990s where you know we saw those kind of management companies come and then get really stressed in terms of assets down the road. That’s different than hooking up with a company whose business is delivering care and again I go back to Physicians Endoscopy and Capital Digestive as an example. That’s a long-term strategic play they’re not bound by a three to five-year window. So, I think practices have to be very careful about who they’re going to give their autonomy and particularly their financial autonomy to.
Praveen Suthrum: So, how does one balance whether at an individual level we agree or disagree with private equity but this is a wave and it seems to be happening. Regardless of what a practice might opine or feel, right? How do you make it better if it is going to happen anyways you know how do you put you know checks and balances in place in such a way that it doesn’t hurt patient care?
Dr. John Allen: I think there are ways. And first of all, as you know better than I there are probably 200 private equity companies that are targeting medical practices GI things like that and there are a lot of differences between those companies. If you have a company that’s going in with a really financial dent that’s just absolutely brutal I would be a little bit hesitant. But there are some really good private equity companies that are coming in and taking practices that have multiple EMRs for example and combining them into one and then planning to use those big data to give real patient outcomes. And you can almost accumulate enough patients to target a big payor and say “We will look at your patients and show that we can deliver better care.” When you go in with that dent whether it’s private equity or a strategic partner I think managing populations again whether it’s gastroenterology, or cardiology or what can improve care a lot. There are a lot of inefficiencies and those inefficiencies are going to be definitely stripped out.
Praveen Suthrum: What kind of advice do you have for an early stage gastroenterologist who might be watching this? How should they plan their career over the next five-ten years?
Dr. John Allen: Well, I think there’s a great opportunity I think you have to be very careful about where you end up being employed whether it’s a health system or a practice. It goes back to the very basics. If the primary purpose of that practice or health system is to deliver good patient care then that’s going to come out in your interviews, it’s going to come out and how the contracts are structured, it’s going to come out in talking with the partners of the health system. You’re going to be able to tell the difference between that and a practice or health system that is financially driven. Obviously, I would choose the former. I do think that the consolidation trend will definitely continue I think that going into a small practice right now except in some of those niche areas that I mentioned is very difficult and challenging. But you want a practice that is well run, that is patient-focused, and also is embracing the new technologies that we have – AI, remote patient monitoring, basically using technology to get rid of all of the routine stuff and strip out costs from what we do. Whether it’s colonoscopy preps delivered by bots or anything like that. You have to be thinking along those lines to really be successful.
I do think you have to have a more consolidated large practice whether it’s multi-state or single state depends on the region. You also have to have a capital partner and professional management that is really good and can anticipate changes. But I do see the practice of gastroenterology really consolidating like that. I think in the academic realm, it’s going to be very tough. And academic centers that don’t morph into a true integrated healthcare system are going to have a very tough time competing with the integrated healthcare systems that are out there. And there are some really good ones. You cannot live on high tertiary quaternary care alone you have to be able to deliver that secondary care and primary care. And then also, you know, offloading the most routine care. I think at the primary care level, a health system that can partner with some of the retail pharmacies or some of the, now technology companies that are coming into you know, the lowest level routine care. I think you’ve got to partner with them. We’re not going to be able to fight you know the Humanas, the CVSs the Aetnas the Optums in terms of routine primary care so let’s partner with them and use that as a win-win and really deliver the care that we need to.
Praveen Suthrum: My final question Dr. Allen, I want to go back to this whole COVID period right. Like so to a lot of people especially in healthcare it’s also been a time for reflection. And people have reflected on their own careers at an individual level but also overall at a larger healthcare industry or at a systemic level. Now if you go back to our healthcare system, whichever part of the world, to a pre-COVID world there’s been increasing patient and physician distrust like you know with each other, then there is this whole business of healthcare aspect. The fact that there have been several articles about the evils of the corporatization of medicine and so on. Now this reflective period of this lockdown, COVID, and everything else surrounding it presents also an opportunity to re-imagine a newer healthcare system you know, that’s more geared toward doing good and being really a force for good for patient care. So, I want to ask you if you were to reflect on something like that. What would a healthcare system look like in your view?
Dr. John Allen: Well, the first thing is we have to acknowledge that this is not only COVID but the racial and economic inequities in this country are I think, simply intolerable, immoral, and unethical. When George Floyd was murdered in Minneapolis I was sitting about nine miles from that corner. And what happened in Minneapolis and now is spread across the country, has demonstrated that we still have some really tough problems to solve. With COVID coming along no matter what your politics, all you have to do is look at the statistics of who is most affected by this and it is people that have that are suffering from health disparities. So, the future in terms of healthcare or gastroenterology really has to reflect that. We can’t be in this for profit. We have to re-establish our credentials as the physician who not only says “do no harm” but feels a responsibility for the individual patient for our community and for society at large. And I think that means moving toward an infrastructure where we have healthcare for everybody however that’s delivered remains to be seen.
But to have uninsured Americans or to have Americans that simply cannot access healthcare at a fundamental level again I just think is an immoral place for this country to be. And I think we have to step up with that and decide how we want to use our resources. It gets into the whole wealth redistribution it gets into the entire economy and tax situation but at some point, we have to level the playing field and I think we have an obligation to take care of people. So, we go on from this I think really reflecting on what our individual and what our society responsibilities are is going to be very important.
Praveen Suthrum: You know we know being inside the system that preventative care will probably result in fewer procedures but then the system gets compensated by more procedures because that’s what we’ve built so far. And we keep talking about you know value-based care, but you know the evolution of that is very slow in what whatever we can see. So, how does one balance that? Because if a hospital does not do procedures then it can’t survive at you know, at an economic level? But if it goes and invests in say getting people in shape for example, right like you know, reversing their conditions that’s probably the right thing to do because then they don’t end up you know needing the procedures but then if they end up doing who pays for that? And how does one balance in both these worlds?
Dr. John Allen: Well, you’re right we’re paid a lot for the complications that we cause. I mean that’s basically what you’re saying and for illness. I do see a movement. So, for example, a line of health just signed a six-year contract with Blue Cross Blue Shield of Minnesota that switches to a value-based system with a basically a ten percent, two-sided risk in terms of reimbursement. But coming with a partnership around the reduction in pre-authorization and administrative costs, and opening up of data systems. So, Michigan is doing a similar program not quite that robust with Blue Cross Blue Shield of Michigan. So, I think both the payors and health systems are realizing that we have to put real money on the table to partner and not be at odds with each other. So, I see that movement actually happening faster. And that will have some tremendous benefits. I think there’s going to have to be an investment in health disparities because that’s where a lot of these costs come from and that’s going to have to come at either a state or federal level. We have to admit that there is a role for both the state and federal governments in supporting those kinds of health disparities.
You’re talking really hard economics we can get into a discussion about wealth consolidation in this country and what it means, but I think this is a time of reflection and a pandemic that hits like this really brings out how weak our safety net in this country was. I think there are a lot of people that are interested in changing that. So, we’ll see what happens but I mean there is no way I mean, I remember hearing Uwe Reinhardt many years ago saying, “Look however it works people that are earning more than 75,000 dollars have to shift some of their wealth to those that are earning less than 75,000 dollars to provide healthcare there’s just no other way to do it.” There are some hard questions that we have simply kicked down the road that I don’t think we can do that anymore. I know that’s not a great answer to your question but it’s you know it’s the best that I can do.
Praveen Suthrum: I don’t think I was even looking for an answer because there is really no straight answer here. Just a reflection which I was seeking and you know which you gave and I really appreciate that. Dr. Allen, thank you so much for sharing all your perspective. It was very insightful. And yeah thank you also for being so candid with everything. I really appreciate that. Was there anything else that you wish to share before we close?
Dr. John Allen: No I don’t think so I think these forums that you put together are really interesting and keep doing them basically. I really appreciate the opportunity to talk with you and to reflect on this and to really think about the future.
Praveen Suthrum: Thank you.

By Praveen Suthrum, President & Co-Founder, NextServices. 

COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
11 Sep 2020

Interview with Dr. Fourment, CEO of Precision Research: “Clinical research will be very different in five years”

Christopher Fourment, M.D is the President and CEO of Clinical Research Strategy Group and Precision Research (Texas).
In this interview, you’ll learn why Dr. Fourment chose to focus on clinical research as a career path. Dr. Fourment also walks us through the various aspects involved in clinical research and how CRSG and Precision Research are helping GI physicians build a sustainable ancillary for their practice. He also reflects on the role of the future of clinical research in a digital world.
Watch this insightful interview in full to learn what it takes to create a clinical trials ancillary in gastroenterology (14+min). 
◘  The difference between CRSG and Precision Research
◘ “We do a lot of the heavy-lifting which allows the sites to do what they do best”
◘  How and why Dr. Fourment built a career focused on research
◘  “Doing research as an ancillary helps everyone”
◘  “…an average patient visit generating $1,700 to $1,800 per visit”
◘  Profitability in clinical research
◘  Steps practices can take to engage with CRSG and Precision Research
◘  Playing the role of a co-director
◘ “The end goal is that I want to build research in their practice that is sustainable for them (the practice)”
◘  What GI research is getting sponsored right now
◘  “The research landscape in five years is going to be very different”

The Transcribed Interview:
Praveen Suthrum: Dr. Chris Fourment, thank you so much for joining me in today for this conversation on clinical research. You are the President and CEO of Clinical Research Strategy Group as well as Precision Research. So glad that we’re speaking finally and happy to get started.
Dr. Chris Fourment: Thanks for having me on, Praveen.
Praveen Suthrum: I wanted to start by asking you that what is the difference between the two companies that you run, CRSG and Precision Research?
Dr. Chris Fourment: It’s kind of how they conduct business is the main difference. So, for Clinical Research Strategy Group, the customers for CRSG are – one site that really wants to build research but doesn’t know how to get started. Doesn’t want to take the time to build or to figure out how to build infrastructure. The second customer for CRSG is the site that is already built and already running research but maybe wants to take it to the next level whether it’s just increasing profitability, increasing the geographic size, and scalability. But the key with that group is to really provide to groups that want to do good research the tools to build the infrastructure and allow them to be sustainable long-term on their own.
With Precision research, it is called a Centrally Integrated Research Network or CIRN and what this is… it is a network of really good GI clinical research sites around the country, who have shown a lot of performance in the past, who already do good research, and what Precision does is… it contracts with pharmaceutical companies to bring studies and once we bring the study to the research network, then we handle a lot of the pain points for the sites. We handle a lot of things like the startup, we handle the contracting, and all the budgeting, the regulatory for instance is all done for them. We build out the source documentation we build out the study in the CTMS – Clinical Trials Management System. So, we do a lot of the heavy-lifting, which allows the sites that are part of Precision to do what they do the best… which is to identify patients for trials, and get them in and see the patients.
Praveen Suthrum: How did you personally choose to focus on clinical research versus doing what everybody does – either going into private practice or academic medicine?
Dr. Chris Fourment: Yeah. Great question. So, after medical school, I got an offer from a pharmaceutical company to come into their medical affairs division. And I worked there for seven years in IBD at the pharmaceutical level as a medical science liaison and then a liaison between clinical operations and medical affairs. One of the things that it allowed me to do is see a bunch of clinical research happening across the country. And I saw sites both academic and community practice and worked with those sites in clinical trials. And what I noticed was there were a lot of sites that were probably destined for failure in the next five years. In other words, the burden of doing research at their site was becoming so much that they weren’t going to be able to kind of keep it going. And because of the burden and because of the pull of their regular practice, the doctors were probably at some point going to have to make a choice and decide whether or not they wanted to devote more time to this research effort. Or whether they just wanted to continue their practice.
I then went to work for TDDC in the GI Alliance and worked with a great partner, Dr. Tim Ritter over there. Where we for five years, built that program to one of the premier clinical research programs in the US. And after that, I really decided to continue to do what I think I love doing which is helping sites become really good. Whether or not it is going to be a true ancillary for the practice or whether they just want to improve the clinical resource or be able to offer clinical research to patients.
Praveen Suthrum: Why should GI practices consider research as an ancillary?
Dr. Chris Fourment: Reasons to… I think to do research as an ancillary or to create an ancillary out of it is that it helps everyone. You look at it from the patient’s standpoint, the patients have access to those therapeutic advancements that most won’t have access to for the next 10 years and they have access to them today through clinical research. So, it is a great way to bring those things to the patient sooner. It is a great way to be able to see the patient more. You take IBD as an example; I think all of us believe that in the ideal world we would be able to see our patients sooner than let’s say six months for a visit. And with clinical research, you are able to do that. You are able to see your patience on a graduated scale to make sure that their disease is being aided by the approach that you’re using.
To the practice, to our point, it can certainly be an ancillary. We look at these research visits, and I think ideal to me in my mind is an average patient visit in research generating around $1700 to $1800 per visit. And a coordinator… when I look at how many visits a coordinator ought to have over the course of a month generally speaking what rate looks like to me is somewhere between 20 to 30. So, if you multiply, let’s say 20 visits by about $1800 per visit you can see that if you have the patients in your practice, and you bring research into the practice, it doesn’t take long to really grow into a point where it can become a good ancillary.
So, that’s the direct value for the practice. The indirect value is that not every practice has research going on. And so the way you’re viewed in the community if you have a research program going on at your clinic may be much different than the gastroenterology practice down the street and that could impact things like referrals. As you get referrals from the primary care. That could impact the way the patients sort of view your practice (if you have research). And then the last part is profit. So, if it helps the patient, if it helps the practice, does it help the bottom line? And you know the way that research runs in a lot of cases in practice is it is kind of a break-even type of prospect. But there’s a way to… And a method to really make research become profitable. So, if you like the first two pieces, if you believe that it helps the patient, if you believe that it helps both, directly and indirectly, the practice, there is a way to get profitability.
Praveen Suthrum:  Now, when a practice decides to engage you or work with you, what are the exact steps that they can take?
Dr. Chris Fourment: Well, it depends. In Clinical Research Strategy Group, I mean the best thing to do is reach out. And then, what Clinical Research Strategy Group will do is take a look at where the research is currently in the practice. So, in other words, do they already have a foundation for research? Or are we building a research from scratch? And either one is okay but there are different strategies that go into both of those. One of the things that we rely on heavily is a Clinical Trials Management System. It is sort of like an EMR for research and it allows a lot of transparency into the program. It also allows us to draw metrics on the program.
The other things that we do to get started are – we create as SOPs – standard operating procedures that represent what our sponsors want to see out of the research, and what the FDA wants to see out of the research. We create a corrective and preventative action plan or a CAPA plan. A CAPA plan is what we use when something goes wrong in research and we have a protocol deviation to make sure it doesn’t happen again. The other thing we do is start to establish a budget for the sites based on upon the actual value of the time that they will spend in studies. And we put together the justification letter so that when the sponsor comes back, and says “Well we can’t really give you X number for this particular procedure” you say, “Hey look that’s my policy here at the site.”
With Precision, again we’re looking for sites that already have good research programs going on; they are already doing fantastic research. And what they can do is getting contact, if they have it already and we can look at sort of what that model would look like for them. And the types of studies and studies that we have to offer, that we could bring in, with full Precision services. And we do that at no charge with Precision. So, the sponsor pays us. The site does not. But again, they need to have the CTMS system in place. That is the most important piece because that allows us in the Precision model to be able to build the regulatory file for them, and manage that regulatory file. It allows us to build the source documentation so that they don’t have to (that’s about a 10-hour job for a coordinator). It allows us to build the study into the CTMS system properly to make sure that they are able to run the reports and go through the financial aspects that they need.
Praveen Suthrum: What is your business model in both these companies? How do they pay you? Like, the way you have narrated CRSG seems to be more of a consulting angle, and Precision maybe a little bit different. If you can clarify that, I think it will be helpful for practices to know.
Dr. Chris Fourment: You’re exactly right. So, CRSG is more of a consulting model. The role that we play at the site is more of a co-directorship, right? So, we really partner with that site. And I’m on calls multiple times a week with each of the sites that we work with to make sure that things are going in the right direction. Once you are in the Precision network, short of the cost of the CTMS system, which is nominal…, it is a few $100 a month or something. So, that is the only cost to the site.
Praveen Suthrum: What kind of a budget should they outline? And when they work with you, does it involve costs associated with building a site, if they don’t have one because it requires space.
Dr. Chris Fourment: It’s a great question. So, there is a cost involved obviously, as with any other ancillary. If you build an infusion center, you are going to have to buy infusion pumps, you’re going to have to buy chairs, and you’re going to have to do all that. So, the equipment cost…  what you need to do research – refrigerators, freezers, the centrifuge, things like that. The cost for all those is around $15,000 per site. If you want to do multiple sites, it is going to be sort of amplified there. Again, the cost of the CTMS system is nominal. And it is important to do it individually. So, rather than having just… sort of one-size-fits-all program, we’re able to look at what the site’s needs are, and what the site’s desires are.
Praveen Suthrum: So, I’m guessing it depends on contract to contract?
Dr. Chris Fourment:  Absolutely it does. But you know, the end result or the end goal is that I want to build research in their practice that is sustainable for them. There are a lot of other models and things like that… that would build research in the practice and continue to take it and give the practice a little bit. I want to be able to have this be a sustainable ancillary for the practice.
Praveen Suthrum: What kind of research in GI is going on with the sponsors that you are connected with?
Dr. Chris Fourment: So, there’s a lot of IBD research. Crohn’s and Ulcerative colitis in both phase two and phase three. Phase two is the shorter-term studies and phase three are the longer-term studies. There’s also work on the luminal side in Eosinophilic esophagitis (EoE) and celiac disease and many others. On the hepatology side, there are NASH trials. I think it is a great idea to sort of broaden out our scope and take on IBD studies and also NASH trials. There’s a lot of work going on in both of those spaces and should one sort of ebb and flow, the other one will perhaps be the opposite. In other words, if we cure Inflammatory Bowel Disease, which would be wonderful, then you still have a productive NASH program going on.
Praveen Suthrum: One final question Chris on technology and clinical research. There seems to be a big role for artificial intelligence and more advanced technology in clinical research. Could you share your thoughts on that?
Dr. Chris Fourment:  So, one of the things that COVID has taught us and it was actually a conversation going on prior to COVID was – could we sort of build virtual clinical research? So, could we reach more patients by having a virtual clinical research platform so that we can do informed consents online or via telemedicine, something like that? Could we conduct a visit virtually? So, that’s one side of that. A company that does a great job of that is Rx.Health, with the trial-engage platform they are working on exactly that. Another piece of that puzzle – How do we get patients for our studies easier? So, how do we identify those patients that already exist in our EMR system, without having to do it completely manually? And a company called DAYCAP is invested in that space and really working hard as is Rx.Health. So, I think there are a number of different options that if we look at the research landscape in five years, I think it’s going to be very different. I think all of the aspects of clinical research are not going to be held in a brick and mortar office, I think many of them will be done virtually.
Praveen Suthrum: Thank you very much for all the insights and perspectives. It’s definitely very educational for me and I’m sure it’ll be the same for everybody who’s watching it.
Dr. Chris Fourment:  It was a great discussion this morning. So, I appreciate you for having me on and I appreciate all that you’re doing.
Praveen Suthrum: Thank you so much.

By Praveen Suthrum, President & Co-Founder, NextServices. 

COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
03 Sep 2020

Interview with GB Pratt, CEO of ModifyHealth: We are a 100% aligned to where healthcare is heading


George “G.B.” Pratt is the Founder and CEO of ModifyHealth. The company recently raised $2 million in Series A funding – right in the middle of the pandemic. 
As a “food as medicine” company, ModifyHealth provides fresh, Low-FODMAP and Gluten-free meals to patients suffering from GI conditions. GI practices partner with the company to benefit from a dietary ancillary. 
In this interview, you’ll learn more about ModifyHealth’s business model. A big question GB reflects on is whether ModifyHealth goes against the grain of today’s healthcare model. 
Watch this thought-provoking interview in full (15min.47sec).
◘  GB’s background
◘  How ModifyHealth raised $2M in Series A funding in the middle of COVID-19
◘  “It was probably one of the first ‘zoom only’ fund-raising events”
◘ “We make it simple, effective and profitable for GI practices”
◘  The big picture that VCs are looking for
◘  Operating model of ModifyHealth
◘  Benefits patients get after using ModifyHealth
◘  “79% of patients report life-changing relief”
◘  The economic model of ModifyHealth
◘  “For most of our patients it’s cost-neutral” 
◘  Benefit for GI practices referring to ModifyHealth
◘ “We’re a 100% aligned to where healthcare is heading”



By Praveen Suthrum, President & Co-Founder, NextServices. 

COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
19 Aug 2020

Want to be a physician-entrepreneur? Get these insights from Dr. Don Lazas


In this video, Dr. Don Lazas shares his insights on how GI physicians can take the spirit of entrepreneurship beyond private practice. 


The Transcribed Interview:
Praveen Suthrum: You are a physician entrepreneur involved in many different companies. And there are a lot of physicians out there, gastroenterologists particularly, who want to go through perhaps what you’ve gone through. So, I have a twofold question here – What has been your journey like? And what advice do you have for physicians who want to follow your path?
Dr. Don Lazas: Well, a very interesting question and you know, I don’t really think of myself as a pioneer, but I guess in some ways I have been as a gastroenterologist. I look at great innovative thinking inside of practices around the country and there are some really smart, business-oriented gastroenterologists. I met a lot of them that are really leveraging their business knowledge and their calculated risk tolerance to develop important new ventures inside their practice and I think that’s spectacular. I really applaud that and love that entrepreneurial spirit. But I think, the same spirit can extend beyond the practice, you know.
One of the things that I’ve learned, when we started our investment company several years ago, I knew what I brought to the table. So, I knew clinical medicine, I knew gastroenterology, I knew the doctor-patient relationship and I had a sense where technology was going to take the field of healthcare in terms of digital health. And all that excited me a lot. But what I didn’t know, I made a very calculated decision, to partner with other individuals who brought other skills to the table. So, those could be business skills, healthcare operator skills, banking and legal skills, deal skills – how do you construct a deal? How do you negotiate with an entrepreneur to invest in their company? People who had been in venture capital learned a lot through partnering with smart individuals.
So, I think the most important thing that I could share is – If you’re interested, start reaching out to folks in the community that you know and respect. And begin talking to them about your interests and entrepreneurial activities. There’s two ways to go. You starting your own venture. I think there are a lot of resources out there that can help healthcare entrepreneurs learn about the mechanics of how to start a company. Then there is investing in early-stage companies which I’ve done quite a bit as well and it’s not for the faint of heart. Don’t make it a large part of your portfolio, right? 10% or less. But it’s very exciting, invigorating and I think you win some and you lose some. But I think what you learn is – you learn how to have a mindset of innovation.
You have to take risk. If you’re going to learn anything in life but specifically in entrepreneurial endeavors, you have to be in it. You have to have your hands in it. You have to be doing it. You have to be writing cheques. You have to be investing your time and resources. And until you have your skin in the game, it is really hard to create opportunities and success. I think those are just some general themes that hopefully will be helpful. I always enjoy talking to the entrepreneurs about their interests and I have been quite busy these days with ObjectiveGI, growing the company. So, yeah, that’s just some of my insights.

By Praveen Suthrum, President & Co-Founder, NextServices. 

COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
07 Aug 2020

How to start clinical trials/research as an ancillary in gastroenterology


Over the past few weeks, I spoke to not one, but three physicians who are deeply involved with clinical trials in gastroenterology. 
Dr. Narayanachar MuraliGastroenterology Associates of Orangeburg (South Carolina)
Dr. Don LazasFounder and Chief Medical Officer, ObjectiveGI (Tennessee)
Dr. Chris Fourment, President and CEO of Clinical Research Strategy Group and Precision Research (Texas)
In this interview, you’ll learn three different perspectives on clinical trials/research as an ancillary in a GI practice. We’ll explore the pros/cons, costs, risks, and operating models.
Consider this interview as a primer on starting up with clinical trials/research. In the coming weeks, we’ll release more detailed interviews on the topic.



The Transcribed Interview:
Praveen Suthrum: Hi, my name is Praveen Suthrum and I am the President of NextServices. Thank you for joining me. What you’re about to see are three interviews with the GI leaders involved with clinical research. Like many of you, I have been very interested to learn about what is the right way to go about building a clinical research ancillary in gastroenterology. In this interview, you will meet three people. The first is Dr. Murali who is a gastroenterologist based in South Carolina and he has done clinical research for the last 25 years and you will learn how the field has evolved over the years. The second interview is with Dr. Don Lazas, a gastroenterologist from Tennessee and he’s also the co-founder of a company called ObjectiveGI. ObjectiveGI helps GI practices get started with research initiatives. And you will learn about why he began his company and how to work with them. The third interview is with Dr. Chris Fourment. From the beginning of his career, he has been focused on clinical research as an ancillary. He has worked with large groups such as Texas Digestive and helped them develop their program. He is today the President and CEO of Clinical Research Strategy Group and Precision Research. Like me, I’m sure all of you will find these interviews very insightful. If you have any comments or questions please feel free to leave them and I’ll be sure to get back. Thank you.
Part 1:
Dr. Murali: So, when I was in training, I used to be very closely aligned with the clinical trials manager at the University of Kentucky where I came from and professor McClain who has so much foresight and is an amazing mentor encouraged us to be deeply involved in these trials. You know, we were not just hanging around doing sundry work but he made us understand what trials involve, how it is done, what is the ethics. We got a good grounding in it. So, when I started my practice it naturally came to me to seek out clinical trials. Of course, everything has changed. We used to do these trials quite easily in those days because there was less paperwork. So, I started my first clinical trial in the first year of my practice. For some reason, I was very busy from the first day I started. So, by the third month, I was seeing a lot of patients and initially, there were a lot of drugs that were being tested for… reflux, for ulcers, for heartburn, for Hepatitis C. We got involved in almost all of the trials and for some reason sponsors also tended to gravitate towards my practice. So, I’ve always had a steady interest both from patients and especially from the sponsors.
Until about 10 years ago the paperwork was manageable. Today they have created multiple layers so you not only have the same or more paperwork but you have more scrutiny. And the need for a very accurate paper trial to support your electronic documentation it’s the other way around. So, we have to have three systems one is the study binder which has to be still and it’s around five with all kinds of information. And every paper in that has to match what is in the electronic case report form which is there in the EMR version of the whole thing. And third, as you know in my case, I maintain records through chronological PDF files so it has to match that as well. You have to establish SOPs for everything you do i.e. Standard Operating Procedures. So, that you have a uniform policy of distributing information, authenticating your papers, and being able to account for what you do. It is very hard. If you just have some EMR, you can’t just do that. It’s very hard.
So, you would think an EMR would make your life easy but it can make it very complicated. So, now what the trial designers have done is… they have replicated the paper version using the electronic version. So, we’re supposed to keep all these records for many years. Come to think of it the amount of storage space that I need has become a big problem for me. But as many trials as we have done over the years, I have these boxes which contain all these materials, we send samples and they all take up a lot of space. Everything is sent frozen. So, you know these are bulky containers, I can’t squeeze them I can’t compact them. So, all these things have to be thought of. So, it takes up usable space in my office.
I do these trials for only one reason which is to stay ahead of the game and to offer my patients the very best of options for treatment. You know, today my focus is completely on Inflammatory Bowel Disease. So, I have concurrently about eight or nine clinical trials going on in my practice at this time. So, there is a steady flow of patients, very busy. And as you know my wife, Anu, who is a scientist. She gave up her job to help me. Today, she is the Trials Director and she’s also the sub-investigator on all of the trials with me. She wears so many hats without her I would be doing nothing. So, she really helps me do all the trials correctly and she understands all the regulatory matters very well because she’s an MScR. (Masters by Research)
Advice for starting clinical trials:
It depends on the size of the practice. In a large practice, you can afford to hire a full-time staff to direct the trials, then you can hire subordinate staff to do the blood draws, to handle specimens, to do the ECR of entries, all these things and you can delegate the work. Remember that all comes with payroll, right? So, you’re increasing the payroll. Clinical trials are not a way to make a lot of money. Although, it may seem like that, you know if you just look at the raw numbers you might say “Oh my gosh! You got paid a hundred thousand dollars” or more but then how much of it is going towards other expenses? So, it is a labor-intensive task, and if your motive is to make a lot of money look elsewhere.
Key Considerations:
Number one is to have a very good Trials Manager who is willing to do a lot of other things early on in the business. Because initially, you will not be very busy. So, when you’re having only one or two trials you can’t afford to have the level of staffing that big organizations have. So, the person should really work closely with you and there must be a clear understanding between the PI (which is me) and my staff as to what their delegated duties are. They have to put the patients first. We need to have the patient volume to support the trials. For example, because of my focus on IBD, I have a very large IBD practice. So, I see a lot of patience with Inflammatory Bowel Disease and many of them come from the three-state area to my practice. So, if I want to recruit it is very easy for me to recruit patients.
I don’t usually advertise, I don’t go through other routes, I don’t try to call doctors to refer patients to me, I don’t do any of those things. Fortunately, we have a steady stream of patients some of them very sick, some of them are not responding to current drugs. So, there is a huge need and this has really helped these patients. So, what you do… is at the beginning, even before you do anything, you sign the non-disclosure agreements, you look at the trial design. They’ll send you great detail about what it is all about. You will usually get a floor sheet that will tell you what is the order of things that have to be done.
You should have good cost accounting knowledge in order to budget correctly. Everything is negotiable. So, you have to know your operational costs over and above your cost per unit time of operating your business. So, in my case, I have an integrated practice with both endoscopic services, clinical trials, and clinical practice all in one roof. So, I understand my cost pretty well. You must account for this time that is wasted and time that is taken up with the trials. It is not as simple as – I see a patient, I write a note, and I’m done. There will be so many queries back and forth no matter how meticulous you are. You are going to have queries coming back to you. Each one of those involves logging onto the computer, answering questions, referencing your source documents, clarifying things, repeating labs if necessary. It is very involved. It is not easy; honestly, it is not easy at all. Somebody has to be there to help you.
Risks involved:
Of course, with clinical trials you’re exposing yourself to litigation as well, right? So, you have to be aware of that. You have to know where your comfort level is, what is your knowledge is, how do you manage complications? You need to have a standard operating procedure. So, you need to have a policy and procedure manual in place much as the hospital does. You have been to my practice and you have seen how in-depth everything is, right? So, that is how it has to be. Without that level of connectivity to information and the patients, you can’t do these things.
Part: 2
Why ObjectiveGI?
Dr. Lazas: Well, I think we’ll start with the ‘Why’ first. Gastroenterologists traditionally have understood the value of ancillary services and with consolidation efforts to stay fiercely independent. Whatever your track is with your practice as a gastroenterologist, we all realized the value of ancillaries and sophisticated practices have really built their businesses around extending services around new ancillary lines. The biggest one of the bigger challenges in the ancillary world has been – research. And there’s a reason why only 5% of practices have clinical research and you can talk about some of these challenges. But there’s tremendous upside for research and we see it as a transformational ancillary service in gastroenterology that can really transform patient care that’s part of our tagline at ObjectiveGI. There’s also a tremendous need in the research community in terms of Pharma, a tremendous shortage of qualified sites to conduct clinical trials in most areas of research.
So, really a tremendous opportunity but there are challenges and we stepped into that void to really address the need we felt… that a platform for conducting clinical trials and in the busy workflow of practice wasn’t in order. So, we set out and created ObjectiveGI. We built this at the point of care. My Co-founder and our COO, Colleen Hoke, and I started this company really with a few premises in mind. First of all, we knew that clinical research was most effective, and most valuable when inserted at the point of care in an integrated way where the clinical research literally runs alongside of the clinical team in terms of the day-to-day patient care.
We learned that patients were endeared to this model, they were seeing their physicians more often as an investigator, they were getting education about chronic silent diseases like NASH and their patient engagement experience was really tremendous. So, it really added value to the care paradigm. Second, when we built ObjectiveGI we knew that we had to build a research platform that could be integrated into the workflow of the gastroenterologist. We’re busy transactional doctors, we’re thinking procedures, were thinking how can I get out of the clinic to my ASC to do my scopes, And I understand that having done it for almost 25 years now. So, we knew if we were going to conduct research it had to be done in a workflow friendly way.
The future is Chronic disease management.
We also wanted to select diseases and disease states that really were the future of GI. So, as we know it now, we’re being encouraged and directed to take care of the metabolic syndrome as gastroenterologists and bariatric care, and really the future is chronic disease management. And so, as we started thinking about our focus and interests, we knew that we wanted to be around the management of chronic diseases and oriented towards metabolism disorders and fatty liver disease of course fits that mark quite well.
We now have 14 sites across the U.S. involving approximately 150 providers we started with NASH, I’m sure we will talk about disease states and why in a moment but we have been involved in over 25 NASH trials so this is rather complex research. There’s a tremendous need for this work. There are over 100 NASH trials currently underway. And, five large phase-three trials that will be starting in the coming quarters. So, there’s a tremendous opportunity here for us to do this work across our site network. For instance, if you think about the bariatric care program in a GI practice, it’s easy to start slinging balloons down but if you don’t have a foundation on which to build a sustainable program in bariatric care then you are kind of stuck. But research really foundationally is the most credible way to lay the foundation for other and additional ancillary services.
Traditional joint venture model:
So, it’s a traditional joint venture model. Gastroenterologists are very familiar with this model in terms of the ASC structure. It is far less capital intensive than say starting an ambulatory surgery center or even a pathology lab. Of course, the capitalization is based on ownership in the joint venture partnership. We establish a separate LOC. We have separate banking. Finances are completely transparent, there is no skimming off the top, and it’s not an MSO model. Of course, there are expenses to the joint venture which include fair market value payments to physicians which is the clinical side of research so physical exams, interpreting EKGs, laboratory testing, and some of the training that’s involved. And we have a Medical Director in all of our programs. So, there’s fair market value payments to physicians, there are stipends to patients, there are occupancy costs. On the expense side, we really love to lease space either in the footprint of the GI partner or very close to or in proximity to them. That helps with the workflow. We talk about streamlining and workflow efficiencies, right? It’s good to be embedded or near the practice.
We typically require about 1200 square feet to build our research centers of excellence. And additional expenses will be, of course, employee expense. It is important to note that we hire, train, and manage and then lease back the employees to the joint venture. So, that’s another really critical aspect. And then finally there may be other expenses in terms of leasing. For instance, if we need to lease a fiber scan, our NASH research really requires a fiber scan for all our programs. So, we can lease them through that joint venture. But all of those would be expenses.
The profit-split is based on ownership. We typically like to partner with groups that are five to 30 providers in size. It is important from the standpoint of having a few people. We start with one principal investigator and we like to have two to three sub investigators. When it comes to investment it is typically going to be less than $100,000 on the practice site. We put in our money first. Our partners can invest their money incrementally as needed and we’re very flexible there. And the capital really is spent on standing up the site and getting it going. It takes about $20,000 to outfit a research center in terms of laboratory equipment, and we have to hire and train the employees, we have to lease the space, and then we have to court our sponsors, clients in terms of notifying them that we have a research center. Identifying the trials that we think would be best suited for that new study. Then getting the pre-site selection visit where they sort of review the site, and qualify the site and then awarding the trial and then having a site initiation visit and then subsequently having your first screen and that’s the first revenue event. So, that whole trajectory takes about four months. Most of our research now is in NASH and those trials are very competitive in terms of not enough sites for sponsors and as we’ve developed a network, we have been able to command a premium.
Three parties sign the contract:
So, three parties sign the agreement – the Sponsor, ObjectiveGI, and Principal Investigator at our site – in as a representative for the site. So, the principal investigator has clear responsibilities that are well known and well established in clinical research. They are responsible for oversight of the trial. They’re responsible for doing the clinical work, the clinical aspects of the trial, the record-keeping, reviewing labs, and regulatory and compliance issues, which we support very significantly through our platform.
Working with ObjectiveGI:
Now, what does ObjectiveGI bring? We bring the sponsor relationships. We have very deep relationships at the top of the scientific and clinical teams in the largest Bio-Pharma companies in the world down to very small Biotechs in the NASH space. We bring those relationships, contracting, negotiating the contracts, and budgeting. We have a Quality Assurance team that oversees and monitors and provides training and quality. Of course, we hire and manage the employees as I mentioned earlier and they’re leased back to the joint venture. We do revenue cycle management for clinical trials. We do a lot of internal training for our staff and our sites through our platform. And then our technology platform really is exceptional in helping to refine our processes and scale our processes across our sites and provide technology applications that create the efficiencies in our system, that create better capabilities for pre-screening, for identifying patients for clinical trials.
Part 3:
Dr. Fourment: So, Clinical Research Strategy Group (CRSG), the customers for CRSG are 1) the site that only wants to build research but doesn’t know how to get started, doesn’t want to take the time to build or figure out how to build the infrastructure. The second, customer in CRSG is the site that is already built and already running research but maybe wants to take it to the next level whether it is just increasing the profitability, increasing the geographic size, and scalability. But the key with that group is… to really provide for groups that want to do good research, the tools to build the infrastructure and allow them to be sustainable long-term on their own.
With Precision Research, Precision is called a centrally integrated research network or CERN and what this – it is a network of really good GI clinical research sites around the country who have shown a lot of performance in the past and who already do good research. And what Precision does is, it contracts with pharmaceutical companies who bring studies. And once we bring the study to the research network, then we handle a lot of the pain points for the sites. We handle a lot of things like the startup, we handle the contract, and we handle the budgeting, the regulatory (for instance) is all done for them. We build out the source documentation; we build out the study in the CTMS system or the Clinical Trials Management System. So, we do a lot of the heavy-lifting which allows the sites that are a part of Precision to do what they do the best, which is to identify patients for trials, and get them in, and see the patients.
Dr. Fourment’s background:
So, after medical school, I got an offer from a pharmaceutical company to come into their medical affairs division and I worked for seven years in IBD at the pharmaceutical level as a medical science liaison and liaison between clinical operations and medical affairs in the U.S. So, one of the things that, that allowed me to do is to see a bunch of clinical research happening across the country. And I saw sites both in academic and community practice and worked with those sites in clinical trials.
And what I noticed was that there were a lot of sites that were probably destined for failure in the next five years. In other words, the burden of doing research at their site was becoming so much that they weren’t going to be able to, kind of keep it going. And because of the burden and because of the pull of their regular practice the doctors probably at some point were going to have to make a choice, to decide whether or not they wanted to devote more time to this research effort or whether they just wanted to continue their practice.
I then went to work for TDDC, in the GI alliance and worked with a great partner, Dr. Tim Ritter over there. Where we, for five years built that program, to one of the premier GI clinical research programs in the U.S. And after that, I decided to really continue to do what I think I love doing which is helping sites become really good.
Research as an ancillary:
So, basic reasons I think to do research as an ancillary in the practice and to create an ancillary out of it are that it sort-of helps everyone. If you look at it from the patient standpoint, the patients have access to those therapeutic advancements that most won’t have access to for the next 10 years and they have access to them today through clinical research. So, it’s a great way to bring those things to patients sooner. What it does for patients who don’t have insurance, for instance, is a great option. It is a great way to be able to see patients more.
If you take IBD as an example you know, I think all of us believe that in the ideal world we would be able to see our patients sooner then, let’s say six months for a visit and with research you are able to do that. You are able to see your patience on a graduated scale to make sure that their disease is being aided by the approach that you’re using. It’s a better patient touch. So, that’s what it does for the patient. For the practice, you know, I think to our point it can certainly be an ancillary. You know we look at these research visits, and I think ideal to me in my mind is an average patient visit in research generating around $1700 to $1800 per visit. And when I look at how many visits a coordinator is ought to have over the course of a month generally speaking what a grade looks like for me somewhere between 20 to 30. So, if you multiply let’s say 20 visits by $1800 per visit you can see that if you have the patient in your practice, and you bring research into your practice, it doesn’t take long to really grow to a point where it can become a good ancillary. That’s the direct value for the practice.
The indirect value is that – not every practice has research and so the way you’re viewed in the community if you have a research program going on in your clinic may be much different than the gastroenterology practice down the street. And that could impact things like referrals as you get referrals in from the primary care. That could impact the way that the patient sort of views your practice if you have research. So, there’s both a direct and indirect value to having research in practice.
And then there’s the last part which is profit. So, if it helps the patient, and it helps the practice, does it help the bottom line? And you know, the way that research runs in a lot of cases in practice it’s kind of a break-even type of a prospect. But there’s a way to…in a method to really making research become profitable. So, if you like the first two pieces, if you believe that it helps the patient, if you believe that it helps both directly and indirectly to the practice, there is a way to get profitability.
Clinical Trials Management System:
One of the things that we rely on heavily is a Clinical Trials Management System it is sort of like an EMR for research and it allows a lot of transparency into the program. It also allows us to draw metrics from the program. One of the things that I see often in clinical research programs is if you ask the site how they’re doing in research. They’d say, “Oh we are doing phenomenally well!” Okay. So, how many visits are your coordinators having per month? “Uh…I don’t know, but they’re busy” is the answer that you will get. What we can do with the Clinical Trials Management System is to start to put some metrics in place so that the entire practice has an idea of how we really doing. So, in other words, how many visits are we conducting over the course of a month, how much per average visit are we getting? And that allows us to be able to go month over month, start to see trends. And so, in the practices that I work with, if we don’t have a CTM system in place, we would work to get one in place. So that, we can kind of draw on some of those metrics. That’s an important step. The other things that we do to get started are – we create SOPs (Standard Operating Procedures) that represent what the sponsors want to see out of research, and what the FDA wants to see out of the research. We create a corrective and preventative action plan or a CAPA plan. A CAPA plan is what we use whenever something goes wrong in research and we have a protocol deviation to make sure it doesn’t happen again.
Establishing a budget:
To establish a budget for the sites again based upon the actual value of the time that they’ll spend in studies and we put together justification letters so that when the sponsor comes back and says well we can’t give you X number for this particular procedure you say, ‘ Hey look that’s my policy here at the site’. It’s a holding type to some of the things that you know, are reasonable value for the practice is important. Not taking less than what you’re worth.
The role that we play at the site is more of a Co-directorship, right? So, we really partner with that site and I’m on calls multiple times a week with each of the sites that we work with to make sure that things are going in the right direction.
Costs involved:
So, it is a cost involved, obviously. As with any ancillary, if you build an infusion center you’re going to have to buy infusion pumps, you are going to have to buy chairs, you are going to have to do all of that. For the equipment costs for what you need to do research – refrigerators, freezers, centrifuge, and things like that. The cost for all of those is around $15,000 per site so if you want to do multiple sites it’s going to be sort of amplified there. Again, the cost of the CTM system is nominal. And then CRSG can work in many different models. Either to help identify staff that practice could hire and or we are considering models where we could actually find the staff ourselves and so, depending upon what the practice wants to do, depending on what level of risk they are looking for, we can work within those constructs. And it is important to do it individually so rather than having just a sort of one-size-fits-all kind of a program, we’re able to look at what the site’s needs are and what the site’s desires are.
Now obviously, if they take on a lot of risks, they’re going to keep the majority of the profits in that case. We are taking on a lot of the risks, then the profit shifts to this side.
Types of trials:
So, there is a lot of IBD research, Crohn’s and Ulcerative Colitis, in both phase two and phase three. Phase two trials are the shorter-term studies and phase three are the longer-term studies sometimes out to seven years. So, there is a lot of work that really needs to be done that is on offer right now. There is also work going on the luminal side, and eosinophilic esophagitis, celiac disease, and many others. On the hepatology side, there are NASH trials. And I always recommend that sites should consider broadening out their scope.

By Praveen Suthrum, President & Co-Founder, NextServices. 

COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
27 Jul 2020

Interview with Dr. Alaparthi: Gastroenterology Center of Connecticut joins Hartford HealthCare


Dr. Latha Alaparthi is from Physician Alliance of Connecticut (PACT) and Gastroenterology Center of Connecticut (GCC). She’s also the Vice President at Digestive Health Physicians Association (DHPA). As of July 1st, 2020, PACT GI Center joined Hartford HealthCare Medical Group.
In this interview, learn how a multispecialty GI group made a decision to ally with a regional hospital. Understand what steps PACT GCC took to navigate COVID-19 and what they are doing now to continue endoscopies safely. More importantly, Dr. Alaparthi reflected on how there could be more women in leadership positions in gastroenterology. And how physicians must take care of themselves first.
Watch this fantastic interview that’s soaked with unique insights you won’t get to hear anywhere else.
◘ Dr. Alaparthi’s journey with GCC
◘ The relationship between GCC and PACT
◘ “One of the things we wanted to do was make sure we stabilized our referral base”
◘ The pros and cons of being in a multi-specialty environment
◘ Insights on the big decision to join Hartford Health
◘ What became clear for PACT was to align with an entity that would allow us to remain independent
◘ Does life look the same or does it look different?
◘ How PACT navigated through this competitive landscape?
◘ “We will do what’s best for our patients”
◘ Navigating through the pandemic
◘ “The first few weeks were surreal”
◘ “One of the things that we did early on was to switch to telehealth”
◘ “We were one of the few ASCs that didn’t completely shutdown”
◘ Changes from the patient standpoint
◘  Testing thousands of COVID patients
◘ Staff challenges during COVID
◘ On physicians: “We need to make sure that we take care of ourselves to be able to take care of our patients”
◘ On why there are fewer women leaders in gastroenterology
“It’s basically like running a house”
◘ The future of GI post-COVID


The Transcribed Interview:
Praveen Suthrum: Hi Dr. Latha Alaparthi. Thank you so much for joining me today and I welcome you to our conversation.
Dr. Latha Alaparthi: Thank you. Thanks for having me.
Praveen Suthrum: You are part of the Gastroenterology Center of Connecticut and also the Vice President of DHPA (Digestive Health Physicians Association). So, I want to begin by asking you to share a little bit about your practice.
Dr. Latha Alaparthi: Thank you again Praveen for having me. I have listened to some of the other speakers on this and it’s very informative. So, I hope I can be useful to whoever is tapping into this. So, I joined the group in 2001, I actually met the then program director as part of my program at Yale-New Haven who was actually one of the three physician groups that founded this company – Gastroenterology Center of Connecticut. So, he recruited me to the group and I’ve been with the group since 2001.
The group is grown from a three-member group. By the time I joined it was a seven-member group. I was the seventh person. And now it is at 13 and soon to have three new physicians to be joining us from different parts of the country, including one of them being a Yale-fellow (New York) and one that’s transitioning from California to us. We’ve had some physicians who have joined us and then moved to different parts of the country. But we are 13 at this point and have three more joining us in Connecticut.
Praveen Suthrum: Okay. So, I know that there is a relationship between GCC (Gastroenterology Center of Connecticut) and the group called PACT (Physicians Alliance of Connecticut). Can you clarify what the relationship is?
Dr. Latha Alaparthi: Sure. Gastroenterology Center of Connecticut was an independent PC since founding until 2013 when it became part of the multi-specialty group. We’ve had a close affiliation with the Yale hospitals in terms of admitting our patients, taking care of our patients, teaching obligations, and appointments. In 2012, around that time it became clear that many hospitals, including Yale, were acquiring primary care groups in the area… which was troubling to us. It was troubling because that’s how we get our referrals. And one of the things we wanted to do is to make sure we stabilized our referral base. And one of the founding members along with a few in the community decided to brainstorm forming a group, that allows us to remain independent and secure at least part of our referral base, not all of it, but at least a good part of our referral base so that we don’t feel so threatened.
Praveen Suthrum: Did that happen? Did you secure your referral base?
Dr. Latha Alaparthi: Definitely. It has made us feel more secure. As I said before, it is not that all the referrals are coming from this group but majority do. And it definitely helps us in terms of feeling more secure.
Praveen Suthrum: So, this is a multi-specialty group versus a single-specialty group. What are the pros and cons of being in a multi-specialty environment as a gastroenterologist versus being in a large single-specialty group?
Dr. Latha Alaparthi: So, when PACT formed, it had internal medicine, gastroenterology, nephrology group in the beginning, and then its surgical group joined our group and more recently orthopedics. Majority of the physicians were for internal medicine. The way the group was formed was to make sure that the primary care physicians were always given enough of a voice to impact the long-term process of the company. Because that was really our main intention, to make sure that they were stabilized in order to help us stay secure with our referral base. So, initial issues with the company were just really learning to work with multiple physicians rather than running our own company.
So, if you can think of running a GI group versus a primary care group, they’re completely different. When you’re forming an MSO, a billing group that now has to cater to not only colonoscopy codes but also nursing home codes, that becomes a challenge. So, there was a significant amount of learning in that perspective. Plus, the electronic medical record system had to be catered to different types of visits. So, all that posed its own challenges. So, those I would say are the main challenges, learning to work with other physicians but in general, we learned a lot definitely in the first four-five years. Everything from day-to-day visits to navigating through HR, to billing, EMR, we had to almost start from scratch and build it up.
Praveen Suthrum: How did you manage to divide the cost and responsibilities because, like you said it’s two different worlds, and GI as a specialty is procedure-driven, primary care as a specialty is not as procedure-driven, so the earnings are different. How did you figure out how to work on the costs of the MSO?
Dr. Latha Alaparthi: So, MSO is based on the fee structure and the fee is the same. Our endoscopy center is not part of PACT. It’s actually completely separate from the medical practice. It is still a very much physician-owned entity. We have currently a four-room ASC in two different locations of our practice. So, in terms of cost allocation in the beginning there was a little bit of a give and take. Some units needed more help in certain areas and not others and vice-versa. So, in the end, I think it was a trade-off. For example, some primary care groups were on paper charts and they had to convert to EHR completely so that took a significant amount of time in the beginning. But in terms of this individual cost allocations, it’s all completely kept separate.
Praveen Suthrum: You’ve recently made a big decision to join Hartford HealthCare Medical Group. So, that’s a sea change from probably the existing structure or any of your previous structures. So, I was curious to know how you went about with your decision and the story behind that.
Dr. Latha Alaparthi: That’s a very good question and a tough one to answer in a small-time format but I’ll do my best. We, historically as you can think of are in the greater New Haven area catering to Milford New Haven suburbs and into the Guilford, Branford area along the shoreline. So, historically our practice has always been at the Yale-New Haven entities. We still are very much affiliated we have teaching affiliations; we have leadership positions at Yale-New Haven Hospital. What became clear for PACT is for it to align with an entity that would allow us to remain independent. And what PACT has been able to secure at this point is an ability to continue to remain independent with our structure and MSO intact. So, what we have done is to create a professional service agreement that allows us to remain independent and I’m really hoping that this will be a structure that will be alive for many years to come because I think it is very important for a group like ourselves who fiercely protect their independence to remain so.
Praveen Suthrum: Did Hartford have similar agreements with any other group in the region?
Dr. Latha Alaparthi: Well, as I understand, there are PSAs with groups but this is their first and only MSA.
Praveen Suthrum: The reason that I asked that question was because I wondered if you had a template or they had a template that they followed or are you familiar with similar arrangements in other parts of the country that you’ve said, ‘Oh they’ve done it this way, we can follow them’
Dr. Latha Alaparthi: Apparently not for the MSA. There have been templates within the state for PSAs and they followed that to a large degree but the MSA was unique.
Praveen Suthrum: Practically speaking how does this all work? Does life look the same or does it look different?
Dr. Latha Alaparthi: As of right now not much of a difference except for the change in the way we address ourselves when we pick up the phone. That has been one of the major changes. We have changed our name effectively from the 1st of July from PACT gastroenterology center part of Hartford HealthCare Medical Group. Obviously, that becomes a long introduction so we introduced ourselves as PACT gastroenterology center. In terms of the day-to-day work not much has changed but there’s a significant amount of work ongoing to see where we need to make changes and one of the big things that any company venturing into something like this looks for is to make their footprint known. And I believe Hartford Healthcare is no different and understandably so. There will definitely be more of a presence in terms of logos and signs and signage that will change in the next few weeks.
Praveen Suthrum: How did you navigate through the competitive landscape while making this decision with respect to other hospitals that I’m sure you’re close to and so on.
Dr. Latha Alaparthi: It’s a tough one and I’ve said this to many of my colleagues and as a physician that’s very passionate about what I do and the care I provide for my patients and really respecting my independence and wanting to practice the way we feel is best it has been a tough one to navigate and make sure that we are allowed that freedom as we go forward. And to that end, we’ve had to be very open and discuss this clearly with all sides. So, historically as I mentioned, and I trained at Yale so it’s my fellowship mentor and I know many people from that area and we work very closely at the same time we decided what’s best for us is to align ourselves with Hartford healthcare Medical Group for the prior reasons mentioned.
And so, we’ve been very open both sides stating that we will do what’s best for our patients and we will send our patients where their best cared for and where they feel comfortable. And so, to that end, I really don’t care for feeling like a pawn in territorial situations in states and I’m really hoping that both sides will respect that and we will continue to. I mean it is early stages, but we are led to believe at this time from the conversations we have had, I don’t believe they will really force us to change anything. Both sides have been very accepting, and very open in allowing us to be who we are and actually respect us for who we are.
Praveen Suthrum: Would this arrangement be restrictive for you to go see patients at Yale or there’s nothing like that?
Dr. Latha Alaparthi: No. In fact, in one of the smaller hospitals in Milford where are the only GI group and we have very much of a presence it’s a small hospital and I used to be the President of medical staff before it became part of the Yale healthcare system and now it is part of a Bridgeport hospital which is Yale healthcare system and I’m still the chief of GI there. My colleague David Hass who is the chief of GI at St. Raphael campus. We have leadership positions, I’m on the medical executive board of Yale-New Haven medical practice. So, we have a presence at Yale and I do not believe it will change the way we practice And I really hope it doesn’t come down to that because then I would have to fight for what’s right for my patients.
Praveen Suthrum: Okay. I’ll get to COVID now. Connecticut was one of the earliest affected states when COVID hit. How did you navigate the pandemic and how are things going now?
Dr. Latha Alaparthi: When COVID was sort of erupting in the New York region, we were wrapping up our DHPA meeting in DC. The last day of our meeting was very interesting. We had several meetings. I had I believe 12 meetings at the congressional offices and senate offices and it dwindled down to about three meetings and at the end of the day, we weren’t even sure if we would take our train back because of the New Rochelle shut down because the train Amtrak goes through New Rochelle. It was very interesting, the whole evolution of that. One of the people that was first diagnosed with COVID in Bridgeport hospital was a New Rochelle physician. A physician that lived in New Rochelle but practiced in Bridgeport who unfortunately has since passed; he was a pulmonologist.
So, that’s how things began for us and the first few weeks were surreal and I went from having a normal office day or at least seemingly normal office day that Monday after we returned to within two days to go into a complete shutdown and having to change all of our patients that were on schedule for endoscopies telling them that we don’t know when we will open again. One of the things that we did early on is to try and switch to telehealth. We had been doing telehealth in terms of telemedicine phone calls prior to this I was one of the first few physicians that was using it in my office. But we soon transitioned to telehealth and at that point, the biggest crunch was trying to find the right platform to offer telehealth to our patients that was easy to understand and was reliable in terms of connectivity. And then the endoscopy center. That was a huge issue there was so much unknown. What we could only fall back on were the experiences from Wuhan because we didn’t have any in our country at that time.
We were one of the few ASCs that didn’t completely shut down. We had about 5% of patients coming in per week. Those that absolutely needed their procedures and could not or should not be done in the hospitals for the reasons of COVID. We took extreme precautions like an hour in between patients and such just to make sure that those individuals were able to get through their procedures and since the opening, it has been a whole new paradigm. While we were in the first two weeks of the shutdown, I quickly got thinking that we will need to open our ASC at some point down the road when COVID is still here. We can’t be shut down forever. And we have an obligation to offer these procedures and diagnose patients in a timely manner. So, I came up with a format that I thought at that time made sense because I was very excited about the antibody testing which obviously has not panned out as we expected and I presented it to a few people at DHPA, the exec team and to one of the physicians who’s also a DHPA member and also on the AGA leadership and there was a significant amount of interest and that led us to work with AGA and DHPA and in developing that joint guidance along with all of us involved which was a very relevant practical step for us and still to this day is being used.
Praveen Suthrum: From the patient’s standpoint what kind of change did you notice? Like were they as open to come to the ASC? I know you’ve restarted but what is the sentiment right now?
Dr. Latha Alaparthi: Since we’ve reopened in the last three or four weeks it has been a whole different paradigm shift and now because of the guidances and the increased number of cases, one of the major steps that we take is testing everyone. We have developed a ten-day symptom log not just temperature but other symptoms that can affect gastroenterology in specific including bowel changes etc. We expect our patients to fill that symptom log and also have PCR testing within 72 hours of the procedure. So, testing, tracking, and reminding patients to keep their symptom log and making sure the results are in the chart before they arrive or the procedure or actually before they prep for the procedure has been a task of its own.
It has really put a strain on our staffing which is suffering, which is a whole discussion in itself, added complexity to what we do every day. This is in addition to what we have already done in the endoscopy center which is a significant amount of cleaning in between procedures and PPE that everyone is recommended to wear.
Praveen Suthrum: Are you contact tracing post-procedure? And how are you doing that?
Dr. Latha Alaparthi: So, fortunately to date we have not had anyone that has tested positive after the procedure. So, we have not had to elicit that but we do have a process thought through in place as to how we would contact trace if that were the case. So, what we do now is call patients a week to 10 days out and make sure that they have not had any new symptoms that are suspicious with COVID and also instruct them to call us back if they develop any symptoms within the few weeks after the procedure. Fortunately, we have not had any cases.
Praveen Suthrum: Okay. That’s good to know. How has your staff taken all this and how are you managing that?
Dr. Latha Alaparthi: Yeah. I think it’s a good question and a tough one as well. Well, before I get on to that I want to let you know that between our group and CTGI which is another major group in the state we have tested a thousand patients and we have only a handful of patients who have turned positive. That was at the beginning of the pandemic when the cases were still high so it makes sense. And I believe our case rate was 0.02% or so at the time of positive rate. So, it has been very low in terms of the risk and we continue to test everyone. Our staffing, due to the shutdown of business before furloughed for a couple of weeks until the loans became reality and we were able to bring back our staff. Few staff members went on FMLA or took unemployment because they just could not afford to come back because of young children. Because unlike many other companies that can work remotely. We cannot work remotely. We did stagger our staff when the social distancing was still a significant issue in Connecticut and we quickly created HIPAA reliable home access to some of our patients that could room a patient for me to do telehealth.
So, we had to do a significant amount of workaround to make sure that everything was in place. As many people have said, among my colleagues, we put on a significantly higher number of hours as administrators to take care of fewer people in the pandemic time because of the number of workaround and processes, that we had to recreate as we took care of our patients. As of right now we still have a shortage both on the practice side and the endoscopy side or in the hospitals and in our endoscopy centers because many nurses that were on the borderline, thinking about retiring have decided to retire and many with health issues have decided not to work for the right reasons and many with childcare issues and other obligations have decided not to return. So, it is significantly straining ones that are in the mix and having to absorb work for other staff members that are not in the mix. And this is something that I am trying to navigate through every single day including yesterday. Making sure that nothing that is fully associated with our patient care is compromised because of shortages.
Praveen Suthrum: As a physician, you are putting yourself in risky situations and you are taking care of your patients and then you come home, and then you have to take care of yourself and your family. So, how do you navigate these two worlds of taking care of your patients versus taking care of yourselves and I’m asking on behalf of all physicians.
Dr. Latha Alaparthi: So, like any other first responder or physician out there that is interfacing with patients, I think many don’t realize that we perform procedures that are aerosol-generating. And that’s one of the reasons why our societies have come up with such stringent guidelines. For example, recently restarting the manometry or motility study that we perform in our office we had to come up with clear stringent steps in terms of a precaution we take not just for the patient but for the nurse that performs the testing and for everyone that uses that room subsequently. So, yes, it is a real risk that we take every single day in terms of exposure.
One of the things we should always remember is to make sure that you think about yourself because it is apparent from the statistics and the deficits that we are seeing, we are a very valuable commodity and we need to make sure that we take care of ourselves to be able to continue to take care of our patients. So, in that sense, we use the appropriate PPE and we make sure that we don’t compromise on the steps we’ve put in place to make sure that the patients that are coming in are not high-risk patients. The other aspects are to make sure that there are things that we have in place to relax. Whatever it is that takes your mind off and really takes you to a different sphere. Physical health and of course, my pet peeve is ergonomics. Don’t forget that despite the PPE, to ensure that you’re taking care of all the things that you need to establish your endoscopy rooms to not physically strain yourself or hurt yourself.
Praveen Suthrum: So, Dr. Alaparthi, you are one of the few women physician leaders that I know of in GI. I have a twofold question here. One is that how did you reach the role that you currently have, you play multiple roles. So, how did that happen? The second more important question is why is that the case? Why are there so few women leaders in gastroenterology and medicine as a whole?
Dr. Latha Alaparthi: Thanks for that question. I’ll answer it the best I can with my own experience and maybe the second one I can’t answer fully but I’ll do my best. The first was really… working with my office staff and really handling some of the challenges that became known to some of my peers and my senior physicians and administrators, ‘Oh she is good at this!’ and most of the times it was out of necessity. For example, I was extremely efficient with my schedules because of necessity. I had two young children at home and I had to navigate through hospital rotations, seeing patients in the office, making sure my results resulted back to the patients, etc. When they saw that the billings were at the same as some full-time physicians, and they asked ‘How do you manage this?’
So, I went into looking at everyone’s schedule, I started involving myself in making schedules efficient. Sitting down with the physicians, and telling them how they can navigate through schedules. And some of the issues that came up on a day-to-day basis and how I could handle them diplomatically with the patient and the staff. That became known to some of my staff members who then asked me to take on some leadership roles which like any female physician I said no in the beginning because my children were still younger and in schools. One of my administrators waited until I dropped off my younger daughter at college and met me the next day. And that’s when I took over as a managing partner of our company.
It’s basically like running a house. You look at every aspect of what you’re doing on a day-to-day basis and also the business aspect of it. Making sure that it is efficient and every employee is taken care of. Financial aspects are met with and staying accountable to yourself and your company. One of the things that will engulf you is the number of hours you have to put into the company. So, my involvement was a slow trajectory and before I became a managing partner, I was a president of medical staff, just being involved in with the medical staff at the local hospital, Chief of GI at the same local hospital. So, I had been doing more leadership roles in the community and small leadership roles involved in the executive committee of my company just to help.
In terms of why there are fewer female physicians, especially in private practice, I can’t ask for the past but I do see many women rising into the rolls at this point. And I’m hoping that they’re able to see themselves as leaders just as good at understanding the business aspect of the companies. I believe that is the part that many of us, men and women don’t really get a significant amount of exposure during training. But early on in the group, it is important to pay attention and really get into the details and realize that it’s not difficult to understand once you put your mind to do it. And I’m hoping that… that will change going forward. As we know the double AMCs data and my own daughter’s med school class shows that there are more female positions and medical students now than in the past and I believe that this is a number that will continue to increase and it is important to engage everyone into the leadership mix.
Praveen Suthrum: So, my final question Dr. Alaparthi is, what is the future of GI post COVID?
Dr. Latha Alaparthi: I was thinking through, And I think it is going to be technology. Patients still rely on us and the stress increased recently has definitely worsened functional bowel diseases. I do think that we will focus a lot more on putting technology so that we can take care of patients remotely. And coming up with treatment algorithms that are slightly different from what they are at this point. And hopefully adapt some of the technology that’s available whether it’s social media platforms or along the lines, where we can address patients individually but yet in a group through platforms that are secure and are accessible to patients. I think that this is going to be a new paradigm in the future in trying to keep the social distancing which I believe will be in place for at least the rest of the year if not into the next year.
Praveen Suthrum: What do you see to happen if we fast forward four or five years from now?
Dr. Latha Alaparthi: So, I was about to read a pill cam right before this [interview] and I’m probably going to go back to reading it. So, I think we’re going to try and look for platforms like that for diagnostic purposes which are more wireless and remote that can give us the view that we need and for diagnostic purposes or therapeutic purposes that we can intervene and be therapeutic in terms of interventions or procedures we perform and actually fix things. Home-based testing to some degree, of the things that we do including the pill cam-type testing, will probably increase. In terms of technology, we really need to focus on the platforms that we have and one of the things, for example, even today when I have to take care of patients, I sometimes have to have three EHRs open, which to me, is so detrimental in terms of patient care. I really wish there was interoperability and a lofty goal would be to have a single platform. But interoperability or ease of transitioning from one to the other instead of having to print, scan or import information from one to the other two just so I have information in one place I think is really affecting patient care.
The last would be to make sure that we have patients that have access to the platforms that we are putting in place. I was working with the fellows two days ago in one of the Yale GI clinics and it was clear that several patients that otherwise would have had to take public transportation to come to clinics have really embraced the telehealth platform and they really appreciate the fact that the doctor will call them, go over the treatment options and make sure that they’ve done their testing, that is a very time-sensitive one especially for inflammatory bowel disease, cirrhosis, Hepatitis C, along the lines. And that’s the population that oftentimes has the least access to many of these platforms. So, I feel we need to really keep our minds and eyes open to ensure that while we are innovating that we are also making sure that people have access to them.
Praveen Suthrum: Dr. Alaparthi, thank you so much for all the insights. It has been tremendously educational for me and I’m sure people who are watching this will feel the same. Was there anything that you wanted to share before we close?
Dr. Latha Alaparthi: I think the challenges that we’re facing as people. I really want people to know that each one of us are going through the same things about COVID and the transition. But with the whole challenge, has come the thought process and it almost makes you feel you can innovate because you have a challenge in front of you. And I’m hoping that we all embrace it and bring new ideas to the forefront and make them work.
Thank you for having me.
Praveen Suthrum: Thank you.

By Praveen Suthrum, President & Co-Founder, NextServices. 

COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
14 Jul 2020

Dr. Weinstein (Part 2): “Adapt or die…standing still is not a zero risk option”


Dr. Michael Weinstein is the President & CEO of Capital Digestive Care. As the largest gastroenterology group in the Mid-Atlantic states, Capital Digestive Care cares for 70,000 patients every year. 
In the interview’s second part, Dr. Weinstein talks about how many aspects of the medical practice can be done remotely. He reflects on the future of GI post COVID, his experiences with the giants of gastroenterology (e.g. Dr. Gene Overholt, the father of endoscopy) and what must fellows in GI must focus on. More importantly, he deeply contemplates on social disparity in gastroenterology.
Don’t miss this deeply reflective interview
◘ Two learnings: Telehealth really works…staff can function well remotely”
◘ What’s the future of GI post-COVID?
◘ 30-40% of our visits will be in telehealth
◘ Profitability of ASCs may lag
◘ We’ll get into more chronic care, remote management (obesity, NASH, NAFL)
◘ Clinical research may be more complicated
◘ There were aspects of Scope Forward that predict our need to adapt to COVID
◘ “The last thing I’d like to see is a second wave – it would be a financial disaster”
◘ “Adapt or die…standing still is not a zero risk option”
◘ Doing nothing is not strategy
◘ Reflecting back when Dr. Weinstein was an early career gastroenterologist
◘ Learning from the giants of gastroenterology
◘ Learning from Minnesota GI
◘ “Listen twice as often as you speak. You have two ears and one mouth”
◘ The question early stage GIs shouldn’t ask first…
◘ Reflection on social disparity in gastroenterology
◘ How did we only end up with such a small percentage of African Americans [in Capital Digestive]?
◘ “George Floyd aside…COVID really increased our awareness how healthcare disparities influences outcomes”
◘ “AGA Governing Board – there’s certainly recognition…how did we end up here?”

The Transcribed Interview:
Dr. Michael Weinstein: Most physicians within a month figured out a couple of things that they didn’t realize, one is that telehealth really works! You can actually do telehealth effectively. You can actually take care of patients; you can continue to provide healthcare and you can do it remotely. And the second thing that they have learned is those staff that were working in their offices, doing all that work in their offices, can actually function pretty well remotely. Their staff can work from home, a lot of that back-office services can be done remotely – scheduling, registration, claims, billing all this stuff can happen remotely and it doesn’t have to be under your direct vision. And if it can happen remotely with your staff, well then actually, maybe it can happen remotely in a platform where you do not have to worry about people working from home but somebody else can worry about the people who are working remotely.
Praveen Suthrum: What you just said naturally takes me to my next question, what do you see as the future of GI, post the pandemic?
Dr. Michael Weinstein: Certainly, what we see is that we’re probably going to continue to do telehealth. 30 to 40% of our visits will probably stay in telehealth. It may take a little bit of lobbying with the payors and Medicare although I think Ms. Seema Verma recently said “Oh we’re definitely going to have telehealth after COVID”. So, she still certainly feels it is an absolute necessity. The profitability of our surgery centers may lag. I’m not sure whether we will ever get back to the same profitability, at least not for a few years. I think some of the things that we will have to put in place – some of the provisions, some of the PPEs, some of the scheduling modifications to clean rooms, and things like that. I am not sure if we will ever achieve the same profit margins unless we can get a higher payment.
Praveen Suthrum: Don’t you see more cases coming from the hospital to the surgery centers?
Dr. Michael Weinstein: Yeah. But you know, our centers were relatively busy before. Does that mean we’re going to have to expand our surgery center with space and staff and open another room? Most groups probably have a backlog of three or four months of procedures. So, how do we catch up? Assuming that the patients still want to come in, how do we catch up? At some point, we will have to start doing six days a week. But that means hiring extra staff. I think roughly half of the ambulatory procedures in the country are still performed in hospital outpatient departments. So, there are certainly quite a few patients that might shift to ASC locations.
I think we will get into more chronic care remote management. You know it was already starting to happen before COVID. Looking at how do we manage the epidemic of Obesity and NASH and NAFLD and weight management, that’s more chronic disease management. We learned that our clinical research maybe more complicated at least for a few more months of getting patients enrolled into trials because of the number of visits. We are trying to avoid all the face to face contact. That may require some changes in how the sponsors want protocols to take place. And the standard paper binders for clinical research, there needs to be some change to make those electronic.
I have read most of your Scope Forward book, and there are aspects of it that almost predict the need to adapt to COVID. You didn’t know about COVID but the whole concept of innovation and adapting that you have written about, and talk to people about, it’s like… How did he know that we would have to actually meet and discuss and figure out how to adapt to our workflow? I’m certainly very nervous about what I see in Florida and Arizona and Texas. The last thing I would like to see here is a second wave. That would be a financial disaster if we had to close down again. So, I’m hoping we avoid that. I think most of my partners, certainly my older partners, who are in the high-risk groups for COVID, people who don’t do as well when they get infections; most of them are going to wait for a vaccine before they get comfortable. And that’s probably going to be February or March of 2021.
Praveen Suthrum: It is really a precarious time and whichever way I look at it, you know I read all the reports, from clinical to economic, the thing that I really come back to is that nobody really knows. And there are different estimates that keep changing by the week. Yeah so, the way I see it is you have to go with the flow and you figure it as you go along. You have a distant view; and you fold that future in; and you work in that direction but the situation can be very dynamic and it can change quite quickly.
Dr. Michael Weinstein: Adapt or die… adapt or die and that’s it. So, when we did our strategic planning, and some of the partners were very happy where we were, and their comment was ‘Why do we need to change anything?’ ‘We’re doing so well’ ‘Why don’t we keep doing what we’re doing?’ and the consultant said doing nothing is not a strategy. Standing still is risky. Standing still is not a zero-risk option, it is actually a very risky option. Stand still in the middle of a busy street, you’re going to get run over.
So, you have to constantly adapt. That doesn’t mean you have to get it right every time, you may sort of make a maneuver or make a change that doesn’t work out. You need to measure all of the changes that you make and determine whether or not the adaptation is moving you in the right direction. One of the best talks that I ever gave at one of the meetings was, ‘The 10 things I wish I hadn’t done.’ And it was hard to get to 10. I had to cut down from a list of 15 or 20, to get to the top 10 that I wish I had not done! On the other hand, I probably have that list and longer of the things I think, we did correctly. So, so far so good.
Praveen Suthrum: Dr. Weinstein, reflecting back on your own career, going back all the way when you were an early career gastroenterologist. I’m sure you had certain visions about healthcare and where GI would be at this point of time. So, where does that stand? Based on what all you’re seeing going on right now.
Dr. Michael Weinstein: What we’re able to do right now technologically in healthcare is amazing. But then you get a pandemic and you realize how fragile things are. When I first went into practice, I came out of my fellowship and I joined two gastroenterologists. They went from a group of two to a group of three and they had some close friends I could mention some names but, everybody knew this. So, one of my partners trained with Gene Overholt, one of them was close friends with Jim Frakes. You know, I was able to learn from the giants. Because my two older partners made me go spend time with these soothsayers. You know, Gene Overholt, the father of endoscopy, and Jim Frakes who was really this healthcare business savant.
I went up to Minneapolis to meet the leadership of the Minnesota GI group, and looking at how they saw gastroenterologists, and then just paying attention to what was happening in the Mid-Atlantic area, which was a lot of mergers of insurance companies and mergers of hospitals. So, I think within a few years of going into practice I already sort of had the notion that the only way we’re going to be successful is that we have to be more relevant and we need to have our own endoscopy centers. And with the support of my two partners, I built an endoscopy center in 1985 which was very early almost following the floor plan which Gene Overholt had built in Knoxville. So, lucky to do that.
I don’t think I could have foreseen the need to get this big but along the way that seemed to be an obvious change. And it’s not just GI practice, it’s healthcare delivery. I have a partner that likes to say that when he grew up, his father told him that he had two ears and one mouth, that he should listen twice as often as he speaks. So, the idea is to go listen to people who have been through the trenches and have figured out the good parts and the bad parts. Follow the good parts, avoid the bad parts, and pick and choose. So, I feel very fortunate to have been around a lot of those people over a 30-plus year career. It has been a privilege to lead and hopefully lead things a little better. I have three sons and I sort of pass on some wisdom as I said, you get along as you go through life. None of them went into healthcare, but the advice I gave them was, you know, as you go through life, try to pick up after yourself, don’t leave a mess, and try to leave the world a little better off than you found it. That’s the goal.
Praveen Suthrum: What advice do you have for early-stage gastroenterologists?
Dr. Michael Weinstein: Yeah. I love talking to young fellows, maybe because my kids are sort of around that same age. I think if you’re a fellow and you’re looking for a career, that you get to choose your career, you get to choose what you’re interested in and when you go talk to a group, probably the first thing you should ask is – firstly you should say what you’re interested in, what sort of career you see for yourself. Do you want to be an interventionalist? Do you want a career in IBD? Do you want to do liver? Or do you want to do esophagus work? What’s really your passion? Figure out what your passion is and if you’re talking to a group, does your ability to continue to follow your passion fit with the strategic goals of the practice that you’re talking with? The question that you shouldn’t ask first is – How much are you going to pay me? That’s not the first question to ask. First, explain what you love to do and why you want to do that and that’s what I would do.
I think an independent practice has the best of both worlds now. I think independent practice allows with the advent of larger groups. It allows the ability of somebody to subspecialize, to follow a passion within a big group, and to be fully supported in doing that. So, if you want a different equipment, if you want a different schedule to accommodate that kind of patient care, then it is probably easier to get that done in a bigger group then it is in an academic center. You know, they are coming out of their fellowship, they’ve got 30 years to practice. Again, you have to find something you like to do so that you can get up every morning and then do what you like to do. because if you like what you’re getting up to do it doesn’t feel like work.
Praveen Suthrum: Dr. Weinstein, I want to get to a final question and reflect on that a little bit. It is to do with the social disparity in healthcare. Now, whichever way you slice healthcare it’s quite apparent and all these years and probably decades, we’ve probably pushed this under the rug and it’s come to the floor now. So, I wanted to reflect that with you a little bit and read your thoughts.
Dr. Michael Weinstein: Yeah. I have sort of always considered myself very socially conscious but I was obviously been made apparent more so that as much as I thought that I was we weren’t. We got to a situation, and how we got there I’m not exactly sure but, I know that when I went on our website and I looked at all the photographs of all the physicians in Capital Digestive Care, we seem pretty diverse until you sort of start figuring out the ratios and the numbers and you go ‘How did we only end up with you know, such a small percentage of African-American partners?’ In Washington DC this doesn’t make any sense and I’m not sure how we ended up there. We did. And I don’t feel particularly good about it, I mean we have a lot of women partners, and there is certainly an obvious recognition that is in this Washington DC community, that the healthcare disparities led to some very bad consequences for COVID. And that’s the thing.
I think, George Floyd aside I think COVID really increased our awareness of just how much healthcare disparities can affect health outcomes. Because it is very clear that the percentage of deaths is so much higher amongst the communities who don’t have accessible healthcare, who have comorbid conditions that are poorly managed, obesity, hypertension… Their healthcare disparities, their inability to access healthcare, contributed to their deaths. And their inability to access health care has to be on all of us. We may not be able to fix the financing situation, Medicare, Medicaid coverage, fair payment, but that doesn’t mean that we should ignore the fact that health care disparities exist and that if we care about our communities then we need to provide that care.
I’m on the AGA governing board right now. There’s certainly a recognition. I think for everybody, the light went off and we went ‘How did we end up here?’ This is terrible. This was unintended to end up in this situation and we all want to do something; we all want to make it better because we see the problems but the first thing is that we need to understand why it happened. And one of the things I know in gastroenterology is for whatever reason unintended bias or unintentional bias or whatever it is, the African-American contingents in GI fellowship is 25% of what it should be based upon the population distribution. If 18 to 20% of the population is African-American and if 15 to 18% is Hispanic Latino, then how come the fellows are not equally distributed that way and they’re not, it’s terrible, it’s 10% of GI fellows that are ethnically diverse. We need to study that. We need to figure out why that happened and we need to do something to fix it. And it may take a generation, but if we don’t start on that road, we’re never going to get there.
Praveen Suthrum: Yeah and I’m so glad that you’re recognizing it at an industry level. So, what needs to happen that is not happening not just from the physician disparity standpoint but also the patient population, right? A lot of the problems that we see in healthcare don’t really originate in healthcare they go back to the community so it is more upstream. But then insurances don’t pay for going back and fixing problems upstream and where we are, we have created a system that pays for certain things and that doesn’t pay for preventing those things. So, what must happen if you had to freely reflect on ending this?
Dr. Michael Weinstein: There’s no doubt that we have to go upstream. Obviously, we’re a big group in the Mid-Atlantic area in Washington DC, Metropolitan Area, I am not saying that I have any ability to fix the problems in the country but I live in this community, I am a neighbor in this community, I am an employer in this community, and there are things that I can do for my employees, the children of my employees, the communities of my employees, and I may not be able to fix the whole region, but I can start fixing what I can actually affect.
I have to go upstream. I have already talked about providing internships for high school students, for college students spend time in our practice not from all over the country but just locally, that’s the local high schools, the local colleges. We’re going to have a paid summer internship and we’re going to try to increase the interest in healthcare and do things to promote healthier lifestyles in our community. If everybody would look just in their own communities, and if everybody did that there would be a huge change. So, I don’t have a solution for the whole country, I don’t have a solution for Maryland, but we’ve already decided what we are going to do at least in the community that we can touch.
Praveen Suthrum: Excellent. Thank you very much, Dr. Weinstein. Was there anything else that you wanted to talk about?
Dr. Michael Weinstein: No. Love talking to you, love listening to you, love to keep hearing about innovations and things that are on the horizon, new technologies, stuff like that, that will make it easier for physicians to provide healthcare. So, thank you for all you do.
Praveen Suthrum: Thank you so much for saying that and I really enjoyed our conversation and I’m sure that people who are watching this will also do. Plenty of insights right here. Thank you so much, doctor.
Dr. Michael Weinstein: You’re welcome.


By Praveen Suthrum, President & Co-Founder, NextServices. 

COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
09 Jul 2020

Interview with Dr. Weinstein (Part 1): “This is about what you want to be in 2030”


Dr. Michael Weinstein is the President & CEO of Capital Digestive Care the largest gastroenterology group in the Mid-Atlantic states. He’s also the past President of DHPA (Digestive Health Physicians Association) and member of the governing board at the AGA Institute
Dr. Weinstein’s interview is loaded with so many insights that I’ll be releasing it in two parts. Each part deserves to be watched in full
How Capital Digestive Care grew to be 60+ providers is a story that’s relevant to many groups looking to consolidate regionally. In 2018, they went on a strategy planning retreat to decide what they’d like to be in 2030. That led to the partnership with Physicians Endoscopy.
Dr. Weinstein outlines the benefits of their MSO to private GI practices. Is there going to be a cash payout during transaction? How does it differ from private equity?
Don’t miss this one.
◘ February had 29 days and March had 300!
◘ How CDC ramped up telehealth?
◘  “Now we’re in phase 3. We have opened up our surgery centers”
◘ “So far, we’ve done over 2,000 COVID tests”
◘ Is this going to be the new norm? 
◘ “If we don’t give them [the staff] enough time, I’m afraid they’ll burn out”
◘ Are patients hesitating to come for endoscopy procedures?
◘ How Capital Digestive Care made the decision of partnering with Physicians Endoscopy
◘ “We started building a culture as Capital Digestive Care, different from the individual cultures”
◘ “We were getting all the private equity phone calls”
◘ What did Capital Digestive Care want to be by 2030?
◘ What doctors say: I want to be independent; I want to be in charge of my own life
◘ “To be successful we needed growth”
◘ “Everything in life is timing”
◘  The pros and cons a private GI practice should look at while weighing their options
◘ Is there money upfront in the CDC MSO model?
◘ “The one thing we tell everybody”
◘ “COVID certainly pulled back the blankets on few of the private equity deals”

The Transcribed Interview:
Praveen Suthrum: Dr. Michael Weinstein, you’re the President and CEO of Capital Digestive Care also the past President of DHPA (Digestive Health Physicians Association). Thank you so much for joining me today and I welcome you to our conversation.
Dr. Michael Weinstein: Praveen, it’s a pleasure. I have been looking forward to this. As we get a little older it is always nice to be able to impart a little wisdom.
Praveen Suthrum: So, I want to start by asking how are things going on with you and your practice in Maryland and DC, you’re in the thick of things. So, I’m wondering how are things there?
Dr. Michael Weinstein: Yeah. We say, it has been a very long year you know, very unusual year. February had 29 days and then March had 300! It certainly felt like that. It’s hard to believe that just four months ago, we were in a totally different world. Maryland started to peak with COVID-19 several weeks after New York and then we got very active, we were in the same boat as most of the practices in our country. Closing down our endoscopy centers, only doing emergency procedures, closing down our offices. I think in the first few weeks, we had two main goals. One was ‘How fast can we ramp up telehealth’ which I think everybody did and I think everybody did it with variable success. And the other was ‘How do we keep our inflammatory bowel disease (IBD) patients treated?’ ‘How do we keep our infusion centers open?’ because those patients are so desperately in need of regular infusions. Those were probably the two priorities. Then, the third priority was who can we partake of the Federal support dollars that were available. So, applying for SBA PPP money, making sure we got our HHS money, the first tranche the second tranche. Then making sure we had the legal counsel to advise us as to what we could qualify for.
We are a big group. So, we were having board meetings three times a week to review everything that was going on. Normally, our practice was to do board meetings once a month. We also furloughed 70/80 employees. Our endoscopy centers furloughed employees. It was scary. Now we’re in phase 3, we opened up our surgery centers a few weeks ago. And we were able to do that while we were doing COVID testing for everybody. COVID testing for patients, staff, doctors, everybody! All the staff and doctors get tested regularly. All the patients are tested two-three days before their procedure so that at least when everybody walks in the room, we can be very confident that everybody is negative. So far, we’ve done over 2000 COVID tests. We have only one asymptomatic patient that was positive, we have one staff member who turned positive. So, so far so good. And on follow-up phone calls, seven days and 14 days after the procedure, nobody who was COVID- positive. So far so good (fingers crossed).
Praveen Suthrum: Is this going to be the ‘new norm’ for the better part of this year and even leading up to next year?
Dr. Michael Weinstein: I think we are certainly going to maintain this testing, I’m sure for the next two or three months. It’s interesting, when we reopened our surgery centers, again, following examples of other regions, we opened at 30-35% of our typical volumes. Next week we will go to about 50% of our typical volumes and not until we get into August where we would be up at 75% to 80% of our normal volumes. So, the cases are stretched out a little bit, I think there’s more downtime. I think the staff needs a little bit more time to rest between cases. You know, they’re wearing full PPE so, all that masks, all that gloving, all that doffing and donning of the equipment is very tiring for the staff. If we don’t give them enough time, I’m afraid they’ll burn out. So, we’re going slowly. The day is about an hour and a half longer. And at this point, we’re obviously trying to catch up with the elective priority cases i.e. cases that we should have done two or three months ago or four months ago. We’re still not scheduling routine cases generally so the true routines cases are probably going to end up being delayed till September or later.
Praveen Suthrum: Is there any hesitation on behalf of the patients to come for the elective cases? Are there delays or cancellations? Or have they adjusted to the new norm?
Dr. Michael Weinstein: I think there is one group of patients who are just terrified of catching COVID and even though they’re due for procedure, they should have their procedure, they’re hesitating now saying well can I wait another month? Is it okay if I wait? And obviously, at this point trying to juggle as much as we are, is four weeks really going to make a difference? Probably not, then we’re letting those patients wait.
But then there’s another group of patients, who are so anxious whether or not they have colon cancer or esophagus cancer or they are so nervous about the fact that their procedure was due in April and now it’s July. So, they’re saying ‘oh I’m very overdue!’. So, there are two groups of patients – those who want to come in right away and those who are willing to wait. So, there’s a different fear factor for different patients. At this point, we can accommodate the patient’s wishes.
Praveen Suthrum: Okay. So, I want to go back in time a little bit. I wanted you to reflect on the growth of Capital Digestive Care and what led up to the size it is right now and how you went about your decisions to build a strategic partnership with Physicians Endoscopy.
Dr. Michael Weinstein: So, now let me spin a story. Capital Digestive Care is now a 74/75 physicians’ group but it was obviously not always that way. We did not grow organically to that size. 2007 there was a Gut Club formed and it was a meeting of about nine practices and some solo physicians and we started discussing the pros and cons of mergers of whether or not being a single large practice would be beneficial to the whole group. It took us a while to work through those issues, to figure how we would govern ourselves, what things we would do centrally, what things we would do as the legacy practices within those old offices.
We did work with the legal counsel quite a bit to try and make sure we met the definition of a group practice which for us meant centralizing certain things that define whether or not you’re a group practice. So, centralized billing and collection, finances, HR, policies and procedures, and every aspect that could be centralized and physicians were willing to give up we centralized. And that let us delve into the opportunities for providing ancillary services, particularly laboratory services.
We went live in 2009 as a single group. Everybody who was in the Gut Club did not stay in the single group. The solo doctors didn’t like the idea of not having complete control. They thought it’d be fair if they had a veto power and obviously that doesn’t work when a group of (at that time) 52/53 physicians. So, we did form a governed structure that everybody was in and formed a new group on January 1st 2009. That is so that the old entities could continue to collect their accounts receivable, they continue to own their assets, they leased any assets to the new corporation, and started as a new company on January 1st 2009. Probably one of the most interesting things we did is we went to all insurance companies before we went live and told the insurance companies what we were going to do. That on January 1st all these groups are going to be one new Tax ID number and how were they going to handle the billing and collection under the one Tax ID number for all these physicians who used to have contracts but had 8 different contracts. So, we settled that up with the insurance companies even before we went live.
Over the course of the next 10 years, did a lot of things as one company. We implemented a new EMR, converted three or four practices that had paper charts and converted those to electronic medical records in 2012, built an infrastructure network so that all the offices were connected, all the marketing was centralized and sort of started building a culture as Capital Digestive Care, different from the individual cultures that the separate practices had in their legacy years. That takes time. You know, you get married, but you have to sort of understand your spouse. And all your partners are now your partners while they used to be your competitors. So, it took us a while to work through those issues. Each of the original practices gradually grew.
We looked back in 2018 and we looked at the goals we had when we started, by the time we were in 2018, we had realized that we had pretty much achieved all those goals except the part about continuing to grow. And we were getting all the private equity phone calls, calls from the bankers and the brokers, I know Jim Leavitt very well, I know Jim Weber very well, we were sort of seeing some of the other things that were happening in the country and it was time for a change. We took a weekend, we listened to an Economics consultant from Carnegie Mellon and her main question to us was (it was 2018 at that time) she said, ‘What do you want to be in 2030?’ ‘What does your practice want to look like in 2030 or 10 to 12 years from now?’ ‘What do you want to be?’. What you have to consider is what’s going to happen to healthcare economics over the next few years that you will have to deal with in order to get to 2030. It was a good exercise. I don’t know if you have ever done any strategic planning or participating in any other strategic planning like that.
Praveen Suthrum: I have actually. And it is very interesting because a lot of times you don’t want to extrapolate the present but you want to do away with the present and come up with a different future. For Scope Forward actually, I tried doing that on behalf of the industry. So instead of taking the past to the future, re-imagined the future like you want it to be. So, I’m curious to know what was the outcome of the strategic planning exercise? What did you want to be by 2030?
Dr. Michael Weinstein: You know, if you ask most of the partners, independent and autonomous were probably the two main words that everybody used. ‘I want to be independent; I want to be in charge of my own life’. When they say they are in charge of their own life, they want to be able to manage the surroundings that they see with their own two eyes. How their staff works in their offices, what kind of scheduling they want to do. I have some partners who want to see at least four patients an hour and there are other partners who go ‘No, I only want to see a patient every 30 minutes.’ We wanted to be flexible enough to allow each doctor to kind of choose their own career. If they want to work four days, if they want to work five days a week, or they want to take off 10 or 12 weeks a year or whether they want to work 48 weeks a year. We wanted to maintain that flexibility, that independence, and that autonomy at the same time as being successful.
In our region, we looked at labor markets, what is going to happen in labor markets, how are we going to compete for our employees, how are we going to compete for associates, how are we going to find the next generation of partners. We looked at technology disruption, I know you’re obviously quite an expert on that. What’s going to happen in technology, artificial intelligence, maybe standard endoscopy may not exist. What could happen technologically that could change? We looked at service lines, what things are coming along that we might want to get involved with as far as clinical research, NASH and NAFLD, chronic disease management, imaging, and other things that are coming along that we should add to our care delivery. And we decided that the one common factor amongst all of these things, to be successful was that we needed growth. We needed size, in order to have an employee benefit plan and opportunities for employees that would be attractive. We needed size to be involved in other service lines that require much larger patient volumes to become cost-effective. We needed size to be able to compete against the big hospital systems and the payors which were obviously continuing to consolidate.
So, if size was the common denominator, the next question that she said was, ‘Now that you know what you want to be in 2030, we have to work backward.’ How do we achieve that growth, what are the ways that we can grow as a practice so that we can accomplish the things that we have as our new strategic goals. You know, we had options. We said we don’t need any help we can do this by ourselves. We can just go borrow money from the bank in order to grow our infrastructure, to attract other practices, we’ll just go borrow money. That was not particularly anything that most of the partners wanted to do because as you probably know doctors are generally a little bit risk-averse and the idea of borrowing money did not appeal to too many people. We said, well we could sell ourselves to the hospital. That was the group of doctors who basically wanted to throw their hands up and say ‘I give up’ ‘Let’s just go to the hospital system.’ if you’re familiar with the Mid-Atlantic area Hopkins is very powerful here. I think they have seven or eight hospitals now in the Mid-Atlantic area. MedStar is the other major hospital system in Maryland, they have 10 hospitals. And Innova Health systems in Northern Virginia have five or six hospitals as well. So, some people just thought the hospitals are going to win the game, we should just sell ourselves to the hospital. That seemed to be, you know, the ‘throw in the white towel.’
We looked at the option of private equity and what the typical private equity looks like. It looked a lot like selling yourself to the hospital. it looked a lot like taking a job not with the hospital but taking a job with the private equity company where you definitely lose a lot of control and you give up a lot of your future income for a payday. It seemed to us to be more of an exit strategy. Private equity didn’t sit very well with us, there were too many negatives and the last option was to find a strategic partner. Somebody who had similar goals for 2030. Somebody who was also looking to be successful for a decade or more.
And you know, everything in life is timing. Barry Tanner and I happened to be in a meeting together. We started chatting, he started talking about Physicians Endoscopy, we were talking about Capital Digestive Care. Physicians Endoscopy was trying to figure out how they could help all of their smaller practices. You know it is interesting, when we look at the private equity companies, they have resources but their definition of resources is money. That’s what they bring to the table, they bring money. They bring cash. They’re like a bank but it’s easier to get the money from a private equity company than it is to get it from a bank. Physicians Endoscopy had money but they were an ASC management company. So, they have a substantial team of personnel with 600 employees, with expertise in all of the same areas that we had, practice management expertise. So, we basically merged two teams of people and formed a new MSO.
Now we think we have had conversations with groups in the and the region that people are understanding of the goal, which is to take away the aggregation of the back office, run that as efficiently as possible, develop new service lines, new sources of revenue, and let the physicians do what they do the best which is to take care of patients and set their own schedules and have their autonomy and independence. That’s more or less it. It was interesting. In 2018 we were doing very well. In 2018 everybody was happy, everyone’s income was good, endoscopy centers were busy, we had a very busy anatomy laboratory pathology option, we had eight surgery centers, anesthesia ventures which most big groups in the country have. But the question is what are we going to need in 2030 because those four main areas are not going to be sufficient in 2030, we need to find other avenues.
Praveen Suthrum: From the point of view of the private practice GI group, how does the model look? Like if someone wants to come on-board, and they want to weigh this option versus a private equity option and versus doing it on their own. What are the pros and cons that they would look at?
Dr. Michael Weinstein: The main things that I heard, when I talked to the private equity bankers and brokers was, you can get a big payday upfront, in multiple of 30 or 35% of your income, you know which means you are going to give up 30 to 35% of your income forever but we are going to give you a big multiple upfront. So, it’s basically taking most of your money off the table and agreeing to work for some number of years in exchange for a payday and the way we are going to make things better in the future is that we are going to have “the second bite of the apple”. There’s going to be a flip. Three years, four years, five years, we’re going to get really big and we are going to flip it and then there’s going to be another big payday.
There is not a lot of discussion about how you re-acquire the income that you have given up, how do you repair the 30 or 35% of your income that you sold. Is there any opportunity to repair your income? I don’t think I have ever heard very good arguments about how a private equity company was going to do that. So, with a typical private equity deal, the pro is that you get a lot of money at the beginning and there is a tax advantage because you get that money as a capital gain…If you get that money as a regular income over the next several years, you are paying regular income taxes today is a tax arbitrage on the transaction. But it’s the exit strategy for everybody who is currently there. And it basically brings all the new associates into your practice at roughly 60% or 70% of what the old partners used to earn. Now the new partners will only earn 60 or 70% of what the old partners used to make. So, see that is the attraction for private equity. If you’re thinking you’re going to work only for five years or seven years, it makes perfectly good sense.
Our model is different. There is a transaction upfront, but not giving up 30 or 35%. We have created a management fee of 15%. A very small amount of your income which is placed into the MSO company to help the MSO growth. So, it’s an investment in a new ancillary. The new ancillary company is practice management services, you are investing in that company, you get to own a part of that company, and that becomes a new ancillary source of revenue. Particularly, again part of the alignment with Physicians Endoscopy, is that there are many small practices outside the region, that need practice management services that can just buy practice management services. They don’t need to join the platform group; they don’t need to join Capital Digestive Care. But within the region, the idea is to grow Capital Digestive Care into a much larger practice, into a more relevant practice when it comes to negotiating with hospitals, with payors, with employers, with value-based purchasing, is to become a relevant player for digestive disease management.
Praveen Suthrum: Well, one question that I have on this is, that you said there is a small transaction in the beginning and that’s 15%. Does that mean they are getting money upfront? Or there is no money upfront?
Dr. Michael Weinstein: Oh no, there is money at the beginning. You know in a typical private equity deal you are selling a 30 to 35% at a multiple and the way we have modeled our MSO is that you’re selling 15% but you’re selling it at a similar multiple. So, there is a cash and equity transaction and asset purchase in our model as well. It just leaves you with 85% or more of your typical income. So, you’re not taking that huge drop in the annual income but there is only a small drop in the annual income and there is much more likelihood that, that income can be repaired just by negotiating and having everybody up to the best contract, having everybody be able to participate in a very functional profitable laboratory. It is very easy for most groups to recapture the 15% that they are getting a transaction for. We have already had one group that gave up 15% of its pre-transaction income and after the transaction based on new contracts and pathology and other services, they’re actually going to make more money than they were in their practice. So, no decrease in income and they got a transaction.
Praveen Suthrum: So, let’s take the number 100. So, the value is 100, they get to retain the 85% and you have the 15% left and that, part of it they get cash, and part of it gets converted into equity into the new MSO. Is my understanding correct?
Dr. Michael Weinstein: Correct. So, it’s up to the group. They have an option. If they want to take it all as cash, depending upon the size they could take it all as cash. Or they could roll some of the cash into equity in the MSO as an investment. There is a tax arbitrage on that as well. The cash part of all these private equity transactions is capital gains. So, depending upon where you live you are paying 21 to 27% federal and state capital gains as opposed to regular income taxes which are probably 42 to 47% depending upon where you live, you’re paying regular income taxes. If you roll some of the transaction proceeds into equity, you further delay the tax. So, it almost becomes like another pension plan. You are taking some of your income and you’re putting it into this MSO, which you own a piece of. So, with the money you’re putting in, you’re basically improving the wealth of the value of the MSO. So, when the day comes when you want to sell your equity, in the model that we have it is much easier to move the equity around between partners at market value and when you sell the equity that’s when the tax is realized. So, you basically get taxed to further growth as well.
These are just the financial aspects. One of the things that we say in all of the groups that we talk to as far as joining Capital Digestive Care is that there are certainly some transactional benefits. There’s cash upfront, there’s an equity component, there is a tax arbitrage that sounds very interesting in the first year but after the first month, most physicians want to know how they’re going to recapture the income that they’re giving up. And for us, it was not about the transaction. We tell everybody that this is not about the transaction, this is about the strategy. This is about what do you want to be in 2030. And if you are 50 years old or 45 years old and you’re thinking you’re going to work 10 or 15 years or more then, a typical private equity deal is kind of risky. You’re giving up a lot of income forever and there’s not a lot of ways you’re going to repair that income and I’m not sure how they will recruit in the future.
I don’t think that they have had any trouble yet although COVID certainly pulled back the blankets on a few of the private equity deals. I think that there is an ophthalmology private equity deal that went bankrupt probably because of COVID but also probably because they were already overleveraged. They had already overleveraged the business. The largest private equity platforms were not able to partake in Small Business Administration loans. I think that there may be some other opportunities for federal support for healthcare companies that will hopefully get them through this terrible gully. It is interesting, most of my partners when COVID hit, said, “Mike, you did the most amazing thing, the timing was incredible”. The timing to do this with Physicians Endoscopy. And I’m going “I don’t think we did this because of COVID!” we had no idea that this pandemic was coming and now we feel that we’re actually probably a good position and that we did what we did!


By Praveen Suthrum, President & Co-Founder, NextServices. 

COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
23 Jun 2020

Interview with Dr. Byrne (AI in GI): “There’s a tidal wave of AI coming and we should prepare for that now”

Dr. Michael Byrne is CEO & Founder of Satisfai Health, an artificial intelligence company that aims to deliver the future of gastroenterology. Dr. Byrne is also the founder of ai4gi, a joint venture with Olympus that focuses on AI solutions for colon polyp detection and differentiation. He’s also an interventional endoscopist at Vancouver General Hospital.
I spoke to Dr. Byrne to understand where exactly AI is in gastroenterology. What must private practice gastroenterologists do now? What does the world of GI look like post-COVID? Stay on top of GI trends by watching this thought provoking interview in full.
◘ Dr. Byrne’s various roles in artificial intelligence in gastroenterology
“Will endoscopists who use AI replace those who don’t?”
◘ Patients will ask, “Is that group using the latest technology?”
What if we are mandated to reach an ADR of 40% to get paid
◘ Remember EUS? Lot of people said it would be niche and it won’t take off
◘ Remember NBI? Initially, people thought it was a gimmick
◘ Would DNA testing or liquid biopsy replace endoscopists who use AI for detection?
◘ How many AI initiatives are underway in GI?
◘ Medtronic GI Genius. Which other companies are making progress?
◘ EndoBRAIN received approval in Japan 18 months ago
◘ How far are we before we start  using AI in GI private practice?
◘ What would GI look like post-COVID?
◘ AI can help with clinical trial recruitment in IBD
◘ Can AI do a stand-alone diagnostic in optical biopsy?
◘ How can private practices pivot and take advantage of these technology trends?
◘ Whether you like it or not, it’ll be there in the not too distant future
◘ AI in GI space is beyond endoscopy. Lots of algorithms in IBD, liver disease, patient meta data, predicting cirrhosis and the various -omics.
◘ Scope Forward encompasses a lot of things GI physicians need to know


The Transcribed Interview:
Praveen Suthrum: Dr. Michael Byrne, I want to welcome you. Thank you so much for joining me today. You’re an expert in Artificial Intelligence (AI) in Gastroenterology (GI). You’re the CEO & Founder of Satisfai Health, a company that’s in the AI in GI space. You’re also the founder of ai4gi and an interventional endoscopist. I’m sure I am missing a few hats that you wear. So, it will be great if we start with you telling us about all the different roles that you play as far as AI in gastroenterology is concerned.
Dr. Michael Byrne: Yeah. Thank you, Praveen. I appreciate this invitation and the opportunity to talk about AI and endoscopy. So, as you said, we all wear many hats. So, my hats include being the CEO and Founder of Satisfai Health and I have also founded a joint-venture which we have named ai4gi that I think is reasonably well-known in the GI world of endoscopy. Our vision at Satisfai Health is to become the leading group in AI solutions for detection, diagnosis, and treatment of GI disease, particularly in endoscopy and that’s really where we are putting most of our attention.
So, I am involved in AI at an academic level as you know, I write a lot of leading articles in the GI Journals. I present at the symposia, DDW (Digestive Disease Week), UEGW (United European Gastroenterology Week), all the main GI conferences. Our group and I, we are working at the research and development level for providing solutions in the AI space and also at a commercial level where we are trying to forge increasing relation with the industry. So, I guess that’s a reasonable summary of where I am right now.
Praveen Suthrum: I came across a recent editorial that you had written talking about whether AI in GI particularly in optical biopsy is a hype or reality. You ended that piece by saying that “endoscopists who use AI will replace those who don’t”. So, you know I wanted to take you up on that and ask you to explain what you meant there.
Dr. Michael Byrne: Yeah. I guess you have to be careful with the statements that you make so that you don’t make too many enemies in this space talking about replacing endoscopists! But you know tongue and cheek, there’s a lot in that statement. I do believe that people have to embrace new technology. There are several layers to this answer. There’s a competitive spirit among professionals so, we all want to use hopefully the latest and the greatest technology. There’s curiosity from the public who know all about AI now and it’s benefits and maybe the pitfalls of what AI can bring. And I think going forward, we will probably have mandated performance metrics from the various payors and the regulatory bodies, to look at how we are performing on a day to day basis.
If you use CADe or Computer-Aided Detection as an example, there are several studies that show that this AI-type tool improves the ADR or the Adenoma Detection Rate or in other words looking for precancerous polyps. And several groups in the US, a few years ago, I think it was what was advertising in a competitive fashion, that their group was using the “FUscope”. If you may remember in your previous coverage that the FUscope is the one that had some side lens as well as a forward lens and the idea was that it increased the field of vision of the scope so that you could see more. And, there were some studies that showed that it can out the regular forward-viewing scope from the competitors that could increase the ADR or the Adenoma Detection Rate. So, there were some groups that were advertising to the public: ‘Our group uses the FUscope, this has been shown in studies to improve the pickup rates of polyps, you should come and have your procedure with us’ or in other words, it brought on a competition between groups. So, I think the same will happen with AI. Public who have been availing these services and particularly in healthcare systems like the US will look and see, ‘Okay is that groups using the latest technology? I have heard that AI can help improve the human mysteries’
As I hope and as I expect in the next few years, it is mandated that we reach a certain minimum threshold for performance. So, again I have used the example of the obvious one, colon polyps. That’s the one that most people can relate to. If we are mandated to reach an ADR of say, 40%, I’m going to pick a figure. If you are not reaching that level, by whatever means maybe you won’t be reimbursed and/or your privileges for that procedure will not be renewed by your healthcare institution. And that is maybe the way to drive increasingly better performance. To the naysayers, I’d say remember EUS or endoscopic ultrasound? When that first came out, properly 15-20 years ago, a lot of people said, ‘oh it’s black and white’ ‘it’s going to be niche groups’, ‘it’s going to be very hard to interpret’, ‘we’re not radiologists’ and ‘it won’t take off’. Now you can see it is in every major healthcare institution, driving lots of interventional endoscopy.
Remember the same with the NBI or the narrow-band imaging, the blue light on the endoscope that Olympus got initially and all the other companies like FUJI and Pentax have developed a version of virtual chromoendoscopy since. Initially, NBI was almost felt to be, how can I put it politely…a gimmick or something that most people wouldn’t use because they didn’t know how to interpret what they’re looking at. That’s not the case now. It is driving this visualization of pathology. So, back to your question, will people who don’t use AI get replaced with those who do? Maybe not replaced, but I think, people need to realize that very quickly they have to adopt, get on the train. It’s moving, right? It’s leaving the station.
Praveen Suthrum: Would DNA testing replace or liquid biopsy replace even endoscopists who use AI for detection or for screening? You know, it could be, because if a blood sample is going to tell you whether the patient has cancer, does not have cancer and it’s not doing just for GI-related cancers but say we get to the point where it does for 15 different types of cancers. Then, would they even do an endoscopy on such a patient? And where would that leave some of the AI initiatives which are underway right now?
Dr. Michael Byrne: Now, I think it is a very good point. I think that the scenario that you mentioned that the liquid biopsy, the blood test being very accurate and predictable of certain types of cancers is quite a way away. I mean, I know we are getting lots of biomarkers now for cancer, but I think expecting that next year we are going to have (for example), a blood test that is very accurate for determining your colon cancer risk is aspirational at this point. That doesn’t mean we’re not going to have better and better non-invasive ways to look, whether it’s with imaging, capsule endoscopy, blood tests, or the genetic tests looking for your own risk of colon cancer for example and that, that’s not going to come. I’m sure it is. And maybe that will also help to streamline endoscopy.
So, endoscopy becomes more therapeutical, almost as if you have assessed that somebody has the risk, you’ve assessed that somebody has non-invasive imaging to have polyps, (again for example) on a capsule and then you chase it with your endoscopic procedure to remove those polyps. So, yeah it may take away some of the excessive volumes of screening in endoscopy. It may promote even more appropriate intervention and therapeutic endoscopy or colonoscopy. Will AI play a role there? We still need to see these things when we’re looking for them so, humans still need help. And I feel that the thing we haven’t touched on it in this talk so far is the field of optical biopsy or doing a virtual or real-time pathology evaluation with your eyes or the AI. That will be needed to be aided by technology. Once we find the lesion, we need to know what we’re looking at. So, yeah, very good point but none of these things should be threats. These could all be cooperative interventions, right?
Praveen Suthrum: Okay. So, last year when we spoke for my book, Scope Forward I had asked you how many AI initiatives are underway in GI and you had mentioned that at least a hundred. So, I wanted to ask you how accurate have you been on that prediction?
Dr. Michael Byrne: Well if you look at the publishing, those who are publishing or trying to publish in the main GI journals, then the number must be way more than a hundred. If that’s how we define a group. In the last month alone, I think I have reviewed maybe ten articles to do with AI in endoscopy for the main GI journals and I’m just one reviewer. So, if I’m reviewing ten papers in the last month on AI alone, and they’re all from different groups! You can imagine the number of groups globally who are actively working in this space. I would say probably several hundred groups, looking at this from an R&D or at least from an academic perspective. How many of those are true companies or groups with all the facets, that’s a little hard to define.
Praveen Suthrum: I saw the announcement from Medtronic related to GI Genius. They launched in Europe and they were supposed to launch in the US this year. I’m curious to know if there are other companies that are ready for primetime. Have things been launched already? Can private practices particularly take advantage of any of the AI solutions which are available out there?
Dr. Michael Byrne: So, you correctly mentioned about some approvals for AI in endoscopy in Europe. With the FDA, it’s still a little slow but we’re getting there for sure. There was a thing… I think it was called the ‘First Global Proceedings for AI meeting’, it was in Washington DC in September last year I believe and there were representatives from the FDA, and from the NIH and global thought leaders in this space were there. A lot of these big tech companies – Amazon, Google, and Microsoft people were at this meeting. So, it only got some attention (there) and with the FDA I think things are going to move quite quickly going forward. But as you said, there are some groups that got their CE mark in Europe for detection. So, CADe or Computer-Aided Detection, again in colon polyps, that’s a disease where lots of efforts have been made so far.
So, they include Medtronic with GI Genius, FUJI recently announced that their CAD EYE or their REiLI system has also got CE approval for colon polyp detection or CADe. As have Pentax with their discovery system. I know that Olympus is working incredibly hard in this space too and with optical biopsy or rather CADx but for confidentiality reasons, with my own involvement as I mentioned maybe at the beginning that ai4gi has a co-development agreement with Olympus in polyp and AI. So, I do know Olympus’s plans to a large degree, but I can’t really say any much more right now. But it’s definitely moving very quickly. For CADx or Computer-Aided Differentiation or doing a virtual biopsy or virtual pathology, there is no FDA approval yet to my knowledge. Other than this group by the name of NinePoint Medical, I’m sure you know them. They are doing some great work with VLE or Volumetric Laser Endomicroscopy, mainly in the esophagus (for example) and they have an FDA approval for using an AI tool, the image feature segmentation. But it’s not true optical biopsy. So, more advanced CADx or optical biopsy is still awaited emulation for an FDA approval actually even for a CE as well.
There’s a group in Japan, called EndoBRAIN, who have done a lot of work in the last number of years on CADx or optical biopsy and they did receive an approval from the Japanese version of the FDA called the PMDA (Pharmaceuticals and Medical Devices Agency) about 18 months ago for AI support, for optical diagnosis of colon polyps. So, hopefully, that also sets the scene for other jurisdictions. I think it is important Praveen, to point out that many of these tools, CADe, CADx, detection, differentiation… at the beginning appropriately they should be and will be clinical decisions support tools to help the physician, rather than standalone diagnostics. Because right now we’re not in the space where we can say for certain that, that’s what AI can do. It needs to be an aide to the physician right now. But I think things will change quite quickly.
Praveen Suthrum: So, just to clarify, can a private practice gastroenterologist in the US play with some of these tools as of today or no?
Dr. Michael Byrne: Not right now, because there’s no AI tool in the endoscopy space other than the one that I mentioned with NinePoint Medical for this very sophisticated technology, this VLE device where the AI allows looking for certain features, other than that for colon polyp detection or colon polyp differentiation, there is no FDA approved device as it stands.
Praveen Suthrum: How far are we before the day where they can start using it or at least testing things out?
Dr. Michael Byrne: You know, I’m sure I don’t have an inside track to the FDA processes and what all the groups are doing in terms of their regulatory pathways. But I think, given what has happened in Europe and looking at the huge amount of work that is being published in the journals and the clinical trials that are listed on the website, I think it’s only a matter of short time that the FDA will approve some of these AI devices. So, my best guess is that AI guided detection for polyps will probably be on the market for physicians to use sometime next year.
Praveen Suthrum: Okay. So, as you know we’re in the middle of a pandemic that’s not over yet. And what I have noticed since the beginning of COVID is that a lot of trends that were already underway have accelerated. And these could be business trends or technology trends, be it the number of AI initiatives. So, I want to ask you what kind of a GI world do you see post-COVID?
Dr. Michael Byrne: Well, the very obvious one is what you and I are doing today, we’re having a zoom meeting. And I think with respect to many of my colleagues in my group here in Vancouver, probably didn’t even know what zoom was three months ago. So, you know many physicians are not particularly tech-savvy but it’s very incredible to see how quickly endoscopy for large meetings have gone virtual. So, people are getting more familiar with technology.
As you said, COVID had a lot of significant downsides, a lot of heartache, and disease burden which is very sad, and hopefully, we’re coming out of it now. But a lot of groups focus as you say, in GI, on the COVID effects from the clinical standpoint, to name a few – ‘How COVID impacts patients with Inflammatory Bowel Disease (IBD)’ ‘should we stop or start new biologics?’. ‘The PPE use in endoscopy’ you know, it became fairly quickly clear that endoscopy was a risky procedure for transmission of COVID because of aerosolization for example. ‘How do we triage patients after lockdown?’ So, all of this came out of the recent pandemic. Can AI help in these COVID related situations? I’m sure the answer is yes. We have now huge backlogs for colon cancer screening. There are several papers coming out now showing that the burden of disease in the last three months is really quite alarming. We have to know how best to come out of that. How do we triage these patients? Who gets done first based on urgency and disease likelihood? I’m certain that AI can help to decipher some of that for us. It can see patterns that are hard to see from a traditional regression type model.
Live endoscopy causes which used to be of course mostly people at that facility but transmitted globally that’s all virtual now and is going very well. So, I think this is just going to increase the appetite. We need help with improving clinical trial recruitment overall, in IBD, in other disease states. We need to maybe rely less on human interaction all the time. So, we talked in the last few minutes about CADx or optical biopsy, if in time AI can do a truly standalone diagnostic in an optical biopsy, maybe we can take away the need for an expert pathologist to do some of that very high-volume but very low-hanging fruit work and leave them to do the more difficult work and more important work for cancer diagnosis.
This is more of your expertise than mine in the venture capital and the private equity world. Of course, there has been a huge economic downturn in the last few months and is likely for the foreseeable future and my impression, I’m not sure of yours, is that there is an appetite from such VC and PE groups to look for safe havens or growth havens for their investments. And healthcare has often been a safe haven even in crisis and I think now, groups are seeing that healthcare technology including AI is a safe haven and actually almost certainly a growth haven. So, I think all of these factors will just help promote a quick adoption of AI into our practice (hopefully).
Praveen Suthrum: My final question Dr. Byrne to you is – So, for practices who understand these shifts, they’re seeing that AI is coming, they see these technology shifts coming but then they are currently tied to an older business model where they are doing a lot of endoscopic procedures, seeing patients in the office, but they also see a shift saying all this is going digital. Now, based on everything that you know, what advice do you have for them, how do you pivot and take advantage of what’s happening?
Dr. Michael Byrne: So, again that is a very insightful question. It is tough. There are naysayers out there or there are other people who are slow adopters or may seem to some degree threatened or that they don’t need to pivot their practice quickly to technology such as AI. And we do need to get physician acceptance, physician familiarity with AI so that we can feel comfortable and pass on that message to our patients, right? So, do people need to pivot straight away? Probably not, I mean it will take leaders in the field to have clinical experience in the field in the next year or two or three with all of these tools that will be coming to our hands quite quickly. Beyond that, do people need to prepare right now? I’ve used a phrase in one of my editorials that there’s a tidal wave of AI coming, and we should prepare for that now.
I do believe that’s the case. AI is pervasive in all aspects of our life. Every time you pick up your phone or use Siri or Alexa, every time you search for a flight it is all AI guided as you very well know. AI in genomics, what used to take humans months or longer to find, an AI model can decipher in minutes or hours. If you read any GI journal in the last 18 months or any medical journal in the last 18 months, I would challenge you to find an issue without an article on AI. So, it all shows that this is all coming very quickly. Look in particular at the Pharma and the device medical industry, they are all focusing on better optics, better visualization, new light technology, better resolution, knowing fully that the human eye cannot appreciate all that new data being thrown at them and so that you will need some sort of intelligence built into their endoscopes. So, the OEM’s, the device manufacturers, know this is coming and they’re investing heavily in this space. So, if you’re looking from the outside in, and you are feeling threatened and you feel like you don’t need to bring AI into your practice, maybe that’s okay for now, but in the not-too-distant future, in the next year or two or three, it’ll be there whether you like it or not.
Praveen Suthrum: I wanted to ask you if there was anything else that you wanted to share?
Dr. Michael Byrne: No, I think we touched upon all the main points. Of course, you know, AI is beyond just endoscopy. AI in our GI space for my GI colleagues listening or he medical colleagues, there are lots of predictive algorithms for re-bleeding risk in patients with peptic ulcer disease, for who will respond to certain biologics, in IBD, in liver disease, without using invasive technology looking at bio-data and looking at patient metadata, clinical data, predicting with great accuracy how likely is somebody with viral hepatitis is to get cirrhosis in 12 months’ time. Lots of AI models are showing huge potential in these spaces and we could spend the next half an hour Praveen, if we had that time today, talking about the various omics – the genomics, the transcriptomics, the proteomics, the metabolomics, and the microbiome and the effect of that on GI disease and how AI can help us decipher all those interlacing signals. But again, that would be a very separate and long conversation.
Praveen Suthrum: Yeah. That would make a good part 2 of this interview. But thank you so much for taking the time today.
Dr. Michael Byrne: Praveen, I would just like to say that I have been following many of your publications and your writings in the last couple of years. Your blogs which have been really helpful to show the business side of GI but also where technology is going. Scope Forward which I know is coming out this summer 2020, seems to encompass a lot of things that we as GI physicians need to know. What is the business angle in GI, how does the current crisis that we have come through affect our practice, where’s technology going? All of these things are very important to know and I think you’re doing a great job to encompass it in one space for busy physicians like me to digest it quickly.
Praveen Suthrum: Thank you so much, Dr. Byrne. Thank you for saying so and for taking out the time today.
Dr. Michael Byrne: You’re very welcome. Thank you.


By Praveen Suthrum, President & Co-Founder, NextServices. 

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