Category: Covid19

15 Oct 2020

~3 weeks left to apply: $20B HHS Provider Relief Fund

~3 weeks left to apply: $20B HHS Provider Relief Fund
Last week, The US Department of Health and Human Services (HHS) announced $20 billion in new funding for healthcare providers. This is additional funding.
Three things you need to know:
◘ You have until November 6th, 2020 to apply for this funding.
You can apply for additional funding, even if you received funding earlier.
◘ HHS wants you to receive at least 2% of your patient care revenues from earlier distributions.
– If you didn’t receive that, you can get it now.
– If you got that earlier, then HHS will calculate add-on payments based on what’s left of the $20B + changes in a provider’s operating numbers.


Additional Information:
◘ Providers who began practicing between January and March 2020 can apply for additional funding.
◘ The Phase 3 application is different from the Phase 2, requiring additional revenue and expense data entries in order to calculate payment based on assessed financial impact of COVID-19.
◘ All provider submissions will be reviewed to confirm they have received a Provider Relief Fund payment equal to approximately 2% of patient care revenue from prior general distributions.
◘ Applicants that have not yet received Provider Relief Fund payments of 2% of patient revenue will receive a payment that, when combined with prior payments (if any), equals 2% of patient care revenue.
◘ HRSA has stated that the payments will not be made until it can review applications from all providers.


Action required:
Step 1: Determine Eligibility – All providers eligible for a previous PRF distribution plus new 2020 providers and behavioral health providers may apply.
Step 2: Validate Tax ID Number (TIN) – Recognized TINs will be automatically validated and provider may re-enter portal to complete application. Unrecognized TINs will go through a three-step validation process.
Step 3: Apply for Funding – Documentation required to submit:
– Most recent federal income tax return
– Revenue worksheet (if required by Field 15)
– Operating revenues and expenses
◘ Application should be submitted to the Provider Relief Fund Application and Attestation Portal before Nov. 6, 2020 (11:59 p.m. ET) to be considered for Phase 3 funding.
HHS is urging providers to apply early.


HHS Distributes Another $20B in Provider Relief Funds (RevCycle Intelligence)
Phase 3 General Distribution ( – Learn about the Provider Relief Fund)
CARES Act Provider Relief Fund: For Providers ( – How to apply)
HHS announces $20 billion in new phase 3 provider relief funding (California Medical Association)
COVID-19: Provider Relief Fund General Distribution – Phase 3 (The National Law Review)
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 Oct 2020

AGA talk: What must you know when considering PE (8 factors, 4 risks)

AGA talk: What must you know when considering PE (8 factors, 4 risks)
Here’s a recording of the presentation at the AGA Town Hall (that was held in collaboration with DHPA).
This is what you’ll take away from this talk:
1) State of PE in gastroenterology
2) How exactly does PE operate and make money?
3) The PPM debacle of the 1990s
4) The four forces influencing GI consolidation
5) 8 considerations and 4 risks
6) How to stay relevant independent of your decision
Listen to this full presentation (30+ min) now. Do not miss this one.
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 Oct 2020

Curated GI articles Oct 8th, 2020: Colonoscopy screening numbers starting to rebound

Curated GI articles Oct 8th, 2020:
Colonoscopy screening numbers starting to rebound
Leaders in GI need to be ‘part of the solution not the problem’ (Healio)
Charles M. Nunn, Jr., MD, CPE, MMM, FACPE, from Lynchburg, Virginia, offered six pearls for GIs on how to be the best leader at their practice or institution.
Video: Interview with Dr. Joe Rubinsztain, CEO & Co-Founder of ChronWell: “[Be] with patients in their lives, not in your office (NextServices)
Joe Rubinsztain, MD provides interesting insights on how technology will play a bigger but quieter role in the future.
Colonoscopy screening numbers starting to rebound (Becker’s GI & Endoscopy)
COVID-19 severely affected colonoscopies because of the high risk of transmission, but Pittsburgh-based Allegheny Health Network said screening numbers were beginning to rebound.
AI appears headed for the endoscopy suite (AI in Healthcare)
Nearly 90% of U.S. gastroenterologists are open to using AI for help performing high quality colonoscopies.
Satisfai Health partners with largest Asian GI hospital on artificial intelligence (WSC)
Satisfai Health signed a data licensing with AIG Hospitals, paving the way for global collaboration in AI in GI.
Exact Sciences extends profitable Pfizer marketing agreement (Becker’s GI & Endoscopy)
Since partnering with Pfizer in 2018, Exact Sciences has screened more than 3 million people, and more than 90,000 providers ordered Cologuard for the first time.
Illinois hospital opens endoscopy center as part of $50M+ expansion (Becker’s GI & Endoscopy)
Rockford, Ill.-based Mercyhealth’s Javon Bea Hospital in Rockton, Ill., opened the Rockton Campus Endoscopy Center.
Gastroenterologists Among the Most Likely to Adopt Telemedicine  (Medscape)
GI is one of the top specialties to adopt telemedicine, ranking third behind endocrinology and rheumatology, and that should come as no surprise.
Gastro Health begins offering CapsoCam at home (Becker’s GI & Endoscopy)
Following the FDA’s labeling change, Miami-based Gastro Health now offers patients access to CapsoCam Plus treatments at home.
Endoscopy Insights With Dr. Prateek Sharma (Gastroenterology & Endoscopy News)
Dr. Sharma, discusses two abstracts submitted to the Digestive Disease Week 2020, and a recently published article examining the role of AI in the endoscopy suite.
AI in GI ‘will have durable impact on the practice of medicine’ (Healio)
Sidhartha Sinha, MD, from the division of gastroenterology and hepatology at Stanford Medicine, highlighted advances in technology that will transform the way physicians practice medicine.
AMSURG Reports Nearly 200,000 Patients Have Missed Colonoscopies Since Start of Pandemic  (
Additionally, AMSURG’s analysis found that if this trend continues, it expects to screen almost 32,000 fewer patients for the remainder of 2020 — potentially another 140 undiagnosed cases.
Proton Pump Inhibitors Tied to COVID-19 Risk (Medscape)
In light of this finding, physicians should consider which patients truly need these powerful acid-lowering drugs, said Brennan Spiegel, MD, MSHS.
Noteworthy: 2 surgery centers that have closed in 2020 + 1 on the brink (Becker’s ASC Review)
Here are three noteworthy surgery center closures — both temporary and permanent.
Florida Digestive Health Specialists expands presence (Becker’s GI & Endoscopy)
Bradenton-based Florida Digestive Health Specialists recently opened a new location in Brandon, Fla.
Video: GIs ‘can play a crucial role’ in post-pandemic vaccinations (Healio)
In this video, Freddy Caldera, DO, MS, discusses his paper on reducing the risk for vaccine preventable disease during the COVID-19 pandemic.Video:
Ulcerative Colitis: Adopting the AGA’s Guidelines (Medscape)
Three expert gastroenterologists discuss how this latest update reshapes the management of moderate to severe ulcerative colitis.
The Regueiro Report: Going Digital With IBD (Gastroenterology & Endoscopy News)
According to co-principal investigator Ashish Atreja, MD, at Mount Sinai, patients who have IBD like using digital tools.

Headlines for GI

Opinion: It’s OK for Physicians Not to Go by the Book (MedPage Today)
The future of gastroenterology and other excerpts on industry-changing trends (Becker’s GI & Endoscopy)
CMS soon to cover a new colon cancer DNA test. Plus, 10 takeaways on the first and only FDA approved liquid biopsy test (Nextservices)
New Uses for Telehealth: How Virtual Care Has Extended Its Reach (HealthTech)
FDA grants orphan drug designation to CAR T-cell therapy for advanced gastric cancers (Healio)
AGA releases largest real-world report on safety and effectiveness of fecal microbiota transplantation (FMT) (AGA)
Register Now: Gastroenterology & Artificial Intelligence Global Summit (ASGE)
Interview: Trends Influencing Gastroenterology and all of Healthcare  (RamaOnHealthcare)
Cleveland Clinic: Top 10 medical innovations for 2021 (Becker’s Health IT)
5 ways medical practices can restore patient visit volumes amid a pandemic: report (Fierce Healthcare)
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.
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.
01 Oct 2020

Curated GI articles Sept 30th, 2020: Now a blood test for celiac disease. 95% accuracy. Removes need for biopsy + more

Curated GI articles Sept 30th, 2020:
Now a blood test for celiac disease. 95% accuracy.
Removes need for biopsy + more
AGA Virtual Town Hall: Adapting to Changing Practice Paradigms (AGA)
Upcoming Praveen Suthrum’s (President, NextServices) talk: ‘Things to Consider When Evaluating Whether Private Equity is an Option for You’ – Webinar: October 10, 2020, at 9 a.m. – 4 p.m. EDT
When will the COVID-19 pandemic end? (McKinsey & Company)
Normalcy by spring, herd immunity by fall? Assessing the prospects for an end in 2021.
FDA Launches the Digital Health Center of Excellence (PR Newswire)
“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” said FDA Commissioner Stephen M. Hahn, M.D
Video: Interview with Dr. John Allen (Michigan): “[Expect] pretty stiff headwinds for many years to come” (NextServices)
How do you lead in crisis? Don’t miss this superbly insightful interview.
A short guide for medical professionals in the era of artificial intelligence (NPJ)
A short guide for medical professionals in the era of artificial intelligence – This paper aims to serve as a short, visual and digestible repository of information and details every physician might need to know in the age of A.I.
Device company creates endoscopic measuring device to improve colonoscopies (Becker’s GI & Endoscopy)
Micro-Tech Endoscopy released its Napoleon measuring device, a ruler that sits next to a lesion during a colonoscopy to allow for more accurate polyp measurements, business reports.
FDA authorizes new IND to evaluate impact of multi-strain probiotic DS-01™ on gut microbiota of patients with IBS (PR Newswire)
Seed Health will assemble a comprehensive taxonomic and functional dataset to investigate the role of gut metabolites in IBS.
Blood test can diagnose celiac disease without biopsy with 95% accuracy  (Becker’s GI & Endoscopy)
A new blood test can detect celiac disease with 95 percent accuracy without requiring a biopsy, in what could be a breakthrough for diagnostic testing.
Ascension Seton, UT Health Austin open GI practice (Becker’s GI & Endoscopy)
Austin, Texas-based providers Ascension Seton and UT Health Austin created a clinical partnership to offer gastrointestinal care, UT Health announced Sept. 24.
Some alternative therapies may be beneficial in IBS (Healio)
Some complimentary alternative therapies, including herbal and dietary supplements, may help ease abdominal pain and benefit overall response in patients with irritable bowel syndrome, according to study results.
GI Outlook to focus on how practices adapt, evolve during COVID-19 (Healio)
This year the American Society for Gastrointestinal Endoscopy GI Outlook 2020: GI Practice Intelligence, Innovation and the Patient Care Experience will be held virtually on Oct. 3.
The Sound (If Not the Fury) May Identify IBS (Gastroenterology & Endoscopy News)
Researchers at the Marshall Centre, have used modern technology and big data to decode the rumblings of the gut and predict the likelihood of irritable bowel syndrome.
AGA partners with DIGID to expand GI nutrition education (AGA)
AGA recognizes the importance of nutrition education for digestive conditions.
Breaking the glass ceiling in interventional endoscopy: Practical considerations for women (GI & Hepatology News)
Subspecialty training in advanced endoscopy has become increasingly appealing to GI fellows.
Podcast: Dr. Ellen Scherl on the Art of the Televisit (Gastroenterology & Endoscopy News)
Dr. Ellen Scherl, the Jill Roberts Professor of Inflammatory Bowel Disease at Weill Cornell Medicine talks about telemedicine and the GI consultation in the COVID-19 era and beyond. Interesting perspectives.
Video: The Future of Hepatitis B Treatment (HCP Live)
Man Fung Yuen, MD, PhD, Chief of the Division of Gastroenterology and Hepatology at the University of Hong Kong discusses some new treatments in the pipeline and how personalized medicine could make an impact in HBV treatment.

Headlines for GI

100 things to know about ASCs | 2020 (Becker’s ASC Review)

The future of gastroenterology and other excerpts on industry-changing trends (Becker’s GI & Endoscopy)

CMS soon to cover a new colon cancer DNA test. Plus, 10 takeaways on the first and only FDA approved liquid biopsy test (Nextservices)

Medical historian compares the coronavirus to the 1918 flu pandemic: Both were highly political (CNBC)

Fauci Pushes Back on Herd Immunity at Senate Hearing (Medscape)

ICYMI: Staying financially well in the time of COVID-19 (GI & Hepatology News)

Baseline features may predict more severe symptoms in gastroparesis (Healio)

Interview: Trends Influencing Gastroenterology and all of Healthcare  (RamaOnHealthcare)

Dietary Inflammatory Potential and Risk of Crohn’s Disease and Ulcerative Colitis (AGA)

Fellowship procedure logs: A word of advice for fellows and a call to action for fellowship programs (GI & Hepatology News)

2020 CRC case projections for 50 states, DC (Becker’s GI & Endoscopy)

Close Encounters In the Third Space (Gastroenterology & Endoscopy)

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.
26 Sep 2020

Curated GI articles Sept 24th, 2020: FDA allowing at-home use of CapsoCam Plus + more

Curated GI articles Sept 24th, 2020: FDA allowing at-home use of CapsoCam Plus + more
Verma: CMS will mull which COVID-19 flexibilities may stick around post-pandemic (Fierce Healthcare)
“I think the reviews have been that the plans have really appreciated the flexibility, especially around telehealth and being able to have those midyear benefit changes,” Verma said.
Video: Interview with Dr. John Allen (Michigan): “[Expect] pretty stiff headwinds for many years to come” (NextServices)
Watch this deeply thought-provoking interview that will help you make several business and personal decisions for the long haul.
FDA allowing at-home use of CapsoCam Plus (Becker’s GI & Endoscopy)
The FDA applied a labeling addendum for CapsoVision’s CapsoCam Plus, which will allow for at-home administration of the devices.
Gastro Health 1st in US to use new endoscopic gastroscope (Becker’s GI & Endoscopy)
Miami-based Gastro Health gastroenterologist Daniel Gelrud, MD, was the first gastroenterologist in the U.S. to use the J10 Series Ultrasound Video Gastroscope.
Fujifilm launches AI GI product in Europe (Becker’s GI & Endoscopy)
Fujifilm has made its artificial intelligence colon polyp device the CAD Eye commercially available in Europe.
Biomarker Test Accurately Predicts High-Risk Barrett’s Esophagus  (Gastroenterology & Endoscopy News)
A precision test that combines image analysis and biomarkers might change how clinicians monitor cancer risk in patients with Barrett’s esophagus.
Physician Reimbursement 2021: Who Are the Big Winners? (Medscape)
The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.
A primer on artificial intelligence and its application to endoscopy (GIE Journal)
This article provides a brief overview of AI and its emerging uses in the field of Gastroenterology. Article by Daljeet Chahal, MD and Michael F. Byrne, MA, MD, MRCP, FRCPC.
Liquid Biopsy Might Help Detect, Manage Liver Cancer in the Future  (Medscape)
Liquid biopsy could someday be useful for the early detection and clinical management of hepatocellular carcinoma (HCC).
Screening a rural population for CRC & more: GI specialist Dr. Michael Green on the challenges of rural healthcare & COVID-19 (Becker’s GI & Endoscopy)
Access to healthcare is limited in a rural population, which is concerning when managing colorectal cancer.
Medscape Female Physician Compensation Report 2020 (Medscape)
A survey report by Medscape where more than 4,500 female physicians told their incentive bonus, hours worked, challenges faced, income etc.
Women more likely to have noncirrhotic HCC, underlying NAFLD (Healio)
Compared with men, women had a significantly higher frequency of underlying nonalcoholic fatty liver disease and noncirrhotic hepatocellular carcinoma.
High-risk colon cancer patients don’t know they need screening, study says (Becker’s GI & Endoscopy)
Patients at high risk for colon cancer were unaware of screening protocols, according to the Journal of Gastroenterology and Digestive Systems.
GI Contract Negotiations and Future Projections (ASGE)
Learn from a panel of experts on contracting tips along with projections forward on GI opportunities. Date: September 24, 2020 7:00 PM – 8:15 PM (Central Daylight Time).
Gastroenterology & Artificial Intelligence Global Summit (ASGE)
This year’s Summit will showcase: the basics of AI, the current state of computer vision in GI and Endoscopy, etc. Date: October 17, 2020 – 9:00 AM – 2:00 PM (Central Daylight Time).
Healthcare AI Deals a Tonic for Private Equity Investors (JDSupra)
Healthcare artificial intelligence is a promising sector for PE investors that requires careful navigation, particularly given divergent regulatory approaches.
Video: 7 Takeaways From the AGA’s New Iron-Deficiency Anemia Guidelines (Medscape)
Commentary by David A. Johnson, MD highlighting some of the key take-home messages from the well-written guidelines by AGA.
Video: What if you had a crystal ball to navigate to the future? (Scope Forward)
See this presentation/talk based on the book Scope Forward: The Future of Gastroenterology Is Now in Your Hands. Originally presented at DHPA.

Headlines for GI

Capital Digestive Care grows network & more: 7 GI industry key notes (Becker’s GI & Endoscopy)

The future of gastroenterology and other excerpts on industry-changing trends (Becker’s GI & Endoscopy)

CMS soon to cover a new colon cancer DNA test. Plus, 10 takeaways on the first and only FDA approved liquid biopsy test (Nextservices)

Black, Hispanic COVID-19 patients likely to develop acute pancreatitis (Healio)

New First-Line Standard of Care for Esophageal Cancer? (Medscape)

ICYMI: How COVID-19 has affected gastroenterology practices (MDLinx)

Ambulatory Surgery Centers: How to Prepare for Your First Survey (Gastroenterology & Endoscopy News)

Interview: Trends Influencing Gastroenterology and all of Healthcare  (RamaOnHealthcare)

Inflammatory bowel disease course in liver transplant vs non-liver transplant patients for primary sclerosing cholangitis: LIVIBD, an IG-IBD study (MDLinx)

Tennessee hospital opens endoscopy center (Becker’s GI & Endoscopy)

7 recent reports on gastrointestinal cancer (Healio)

Noninvasive Test May Predict Outcomes in Liver Patients (Gastroenterology & Endoscopy)

Anemia Tied to Higher Risk of Crohn’s Disease, but Not Ulcerative Colitis (Medpage Today)

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.
18 Sep 2020

Curated GI articles Sept 17th, 2020: CMS to cover new colon cancer test. 10 Takeaways on first and only FDA approved liquid biopsy test + more

Curated GI articles Sept 17th, 2020: CMS to cover new colon cancer test. 10 Takeaways on first and only FDA approved liquid biopsy test + more
PE-backed GI procedure documentation software company makes acquisition (Becker’s GI & Endoscopy)
GI software company Provation acquired ePreop, a perioperative software as a service solution.
Video: Interview with Dr. Fourment, CEO of Precision Research: “Clinical research will be very different in five years”  (NextServices)
Watch this insightful interview in full to learn what it takes to create a clinical trials ancillary in gastroenterology.
CMS soon to cover new colon cancer DNA test. 10 takeaways on the first and only FDA approved liquid biopsy test (NextServices)
Epi proColon detects colon cancer through a specific DNA called Septin9. The company expects CMS approval anytime now and is due to launch nationwide.
Capital Digestive Care partners with Peninsula Gastroenterology Associates (Becker’s GI & Endoscopy)
Silver Spring, Md.-based Capital Digestive Care partnered with Delmar, Md.-based Peninsula Gastroenterology Associates.
The great acceleration in healthcare: Six trends to heed (McKinsey & Company)
Next generation care management, health for all, consolidated care delivery, and reform efforts are among the trends that may shape healthcare in the years ahead.
Video: What if you had a crystal ball to navigate to the future? (Scope Forward)
See this presentation/talk based on the book Scope Forward: The Future of Gastroenterology Is Now in Your Hands. Originally presented at DHPA.
Asian, lean patients with NAFLD have lower prevalence of cirrhosis, CVD  (Healio)
Lean Asian patients with nonalcoholic fatty liver disease had significantly lower prevalence of cirrhosis, cardiovascular disease and metabolic abnormalities than lean non-Asian patients.
Googling for Gut Symptoms Predicts Covid Hot Spots, Study Finds  (Bloomberg)
Using Google Trends online tool, they found the volume of searches correlated most strongly with cases in states with high disease burden — three to four weeks later.
Medscape US and International Physicians’ COVID-19 Experience Report: Risk, Burnout, Loneliness  (Medscape)
“More than half of US physicians have personally treated patients with COVID-19.” This survey from Medscape includes over 5,000 US physicians.
Screening delays due to SARS-CoV-2 could increase advanced CRC cases  (Healio)
Delays in colorectal cancer screening due to the cessation of colonoscopies during the COVID-19 pandemic could increase advanced cases and even mortality if the delay stretches beyond 1 year, according to study results.
Can Machine Learning Make Fecal Testing Part of CVD Screening? (MedPage Today)
Early study suggests role for initial routine cardiovascular health monitoring.
Video: ASGE campaign highlights ‘The Value of Colonoscopy’ (Healio)
In this exclusive video, Jennifer Christie, MD, and Douglas K. Rex, MD, discuss “The Value of Colonoscopy,” a new campaign from the ASGE.
Benefit from a tax-savvy investment portfolio (Healio)
Physicians of all specialties want to reduce taxes wherever possible. While most doctors typically focus on active professional income, spending some time and effort on how one’s investments are taxed is also crucial.
Readers Predict Biggest Medical Breakthroughs by 2045 (Medscape)
When Medscape’s readers were asked to predict medical breakthroughs in the next quarter century, the most common responses zeroed in on the human genome.

Headlines for GI

See Gastroenterology’s curated colorectal cancer research collection (AGA)
The future of gastroenterology and other excerpts on industry-changing trends (Becker’s GI & Endoscopy)
Newsletter: Telehealth and the new choreography of ‘anywhere care’  (RamaOnHealthcare)
5 most-read stories in GI this week — Independent practice consolidates & more (Becker’s GI & Endoscopy News)
Sinusitis Linked to Later IBD, Study Finds (Gastroenterology & Endoscopy News)
ICYMI: Nonalcoholic Fatty Liver Disease and Fibrosis Associated With Increased Risk of Cardiovascular Events in a Prospective Study (AGA)
Food Delivery Startup Helps Physicians Treat IBS Patients (Gastroenterology & Endoscopy News)
Interview: Trends Influencing Gastroenterology and all of Healthcare (NextServices)
Infectious COVID-19 Can Persist in Gut for Weeks (Medscape)
5 recent studies exploring AI in healthcare (Becker’s Health IT)
A gastroenterologist’s COVID musings from behind the mask (KevinMD)
How Coronavirus Is Helping Drive The Digitalization Of Healthcare (Forbes)
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.
17 Sep 2020

CMS soon to cover a new colon cancer DNA test. Plus, 10 takeaways on the first and only FDA approved liquid biopsy test.

Epigenomics is a liquid biopsy company listed on the Frankfurt Stock Exchange. Epi proColon detects colon cancer through a specific DNA called Septin9 (altered in colorectal cancer tumor cells). The company expects CMS approval anytime now and is due to launch nationwide in US this year.
These takeaways are based on their Q2 2020 Earnings Call. Frederic Hilke, the Investor Relations Manager for Epigenomics, and Greg Hamilton, the CEO of Epigenomics AG made these remarks.
1. The operational highlights for Epigenomics include:
◘ CMS’ initiation of the National Coverage Determination (NDC) process for Epi proColon in late February.
◘ Inclusion of Epi proColon in the 2020 NCCN guidelines.
◘ Publication in the Journal of the National Cancer Institute (JNCI) which concludes that Epi proColon is the test of choice for patients who are not willing to participate in FIT or colonoscopy screening.
2. Epigenomics believe that the test is necessary as there are an estimated 9 million Medicare beneficiaries who are not willing to participate in FIT or colonoscopy screening.
3. They believe that as the only FDA-approved blood-based test available, Epi proColon has the opportunity to save over 225,000 Medicare lives.
4. Epigenomics also reckoned that the annual Epi proColon testing was found to be clinically more effective than Cologuard (every 3 years) and (annual) FIT testing.
5. The company indicated that it is interesting to note the clinical benefits of Septin9 (Epi proColon) testing vs. an annual stool DNA test.
◘ Despite 92% sensitivity versus 68% sensitivity, the incidence of Colorectal Cancer is nearly identical, and the mortality is equivalent between the two tests.
◘ The implication of this is that even if future blood tests have increased sensitivity, their impact to clinical outcomes will be negligible.
6. The company feels that nearly all future blood-based test and development are going to be next-generation sequencing-based.
7. The company reckoned that annual stool DNA testing is extremely cost-ineffective. Which is why Epigenomics believes that Epi proColon is well-positioned to be the test of choice for an extended period of time.
8. The revenue for Epigenomics in the first half of 2020 was EUR 322,000. According to the company, the decrease between the first half of 2019 and 2020 was due to the effects of COVID-19 during Q2.
9. They feel that there is significant growth potential in 2021. Gregory Hamilton, Epigenomics AG – CEO & Member of the Executive Board commented, “I mean if you just think of the unscreened market alone, there’s 35 million patients who haven’t been screened.”
10. Post reimbursement, one of the key projects that the company is set to work on is expanding the label of Epi proColon from 50 to 75.
Note: The company feels that CMS will issue a positive coverage determination. As Epi proColon has met the required standards and now with the publication in JNCI, there is a published peer-reviewed evidence that Epi proColon is cost-effective and the test of choice for patients unwilling to participate in FIT or colonoscopy screening.
Edited Transcript of ECXn.DE earnings conference call or presentation
Epigenomics Annual Report 2019
Epigenomics AG: CMS Still Actively Working On Proposed Decision Memo with Goal to Publish As Soon As Possible
Related Links:
1) What has colon cancer screening got to do with self-driving cars?
2) Exact Sciences: COVID-19 will accelerate the adoption of Cologuard by one to two years toward ‘40% market share’ goal
3) 20 Takeaways from Exact Sciences call: “Cologuard fits seamlessly into a permanently changed healthcare environment”
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. 

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