Cover Story

A Roadmap to Building a Community HCV Center

The pathway to a truly successful career in any kind of medicine, including hepatitis C virus, traditionally carried a clinician through a major academic health center. To put it bluntly, this is where the money is. With money comes the opportunity to participate in comprehensive and groundbreaking clinical trials, work in the best facilities with the best clinicians and, often, achieve the best patient outcomes.

But at the Liver Meeting last year, Mitchell L. Shiffman, MD, of the Liver Institute of Virginia and Bon Secours Health System, put together a symposium on community-based medicine that highlighted the risks and benefits of breaking away from academia. In short, it is feasible. In fact, according to most of the experts on the panel, it can lead to all of the types of success traditionally enjoyed by practitioners in the major academic health centers, and then some.

The session covered a broad range of topics, from incorporating the business to participating in clinical trials. “When I left academic practice, one thing that was important was providing transplant care locally,” Shiffman said. “This requires desire and commitment and dedication from you and your staff, but it has been incredibly rewarding.”

Many of the experts, including Kimberly L. Beavers, MD, MPH, assistant professor of Gastroenterology and Hepatology at the Medical University of South Carolina, spoke honestly about the ups and downs of stepping away from the system. “You have the opportunity to carve out what you want the practice to be,” she said. “You can do inpatient care, outpatient, transplant. There is so much variability. You can choose when you want to participate in clinical trials. Yes, the work-life balance can be a downside. The nights and weekends are a drawback. But these things are negotiable with planning.”

The symposium was long on the hardboiled practicalities involved in building a community program from the ground up. There was talk of budgets and staff, building relationships with patients and academic centers, and the nuts and bolts of the clinic and the lab. The experts addressed various types of ventures, from solo practice to partnering with a larger center to building a transplant program.

There are huge obstacles. According to Kent Benner, MD, a gastroenterologist with the Oregon Clinic, however, it is entirely possible. “The key to developing programs is collaboration,” he said. “We as members of liver care teams have considerable experience in collaborating with experts in many fields. Managing complex patients with our transplant experience puts us in good stead to set up these community-based programs.”

Taking the Plunge

Paul J. Thuluvath, MD, medical director of The Institute for Digestive Health and Liver Disease at Mercy in Baltimore, was entrenched in academia, first as a lecturer at the University of London and then at Johns Hopkins as chief of hepatology. “One day I decided that I had had enough of mainstream academia,” he said. “I thought about it for some time and ultimately decided that I may be able to do the same thing that I did at Hopkins in a community teaching hospital affiliated to the University of Maryland.”

Thuluvath did research on the hospital he was going to and sought advice from others who had left the system for that particular hospital. “I wanted to know whether they had been able to continue what they were doing,” he said. “After doing the initial research, I deliberated on the topic and had many discussions with the hospital before moving to a center like that.”

He stressed the importance of having a detailed plan before moving. “It’s a culture shock when you move to another hospital without all the infrastructure of a major teaching institution,” he said, and added that it is important to set up short-term and long-term goals and reassess them regularly. “You have to decide on your objectives. You also need to have a timeline for expansion and check whether the hospital shares your vision.”

Mitchell L. Shiffman

Perhaps most important is negotiation with the participating hospital, Thuluvath said. “We had to have the minimal requirements clearly spelled out in the beginning. Give it in writing, budget items, support staff, everything. If it’s not written, it is very difficult to go back and say, ‘Look, you haven’t followed through on what you promised.’”

Thuluvath said that three senior clinicians he had worked with, including the clinical director of inflammatory bowel disease, director of therapeutic endoscopy and director of pancreatic diseases, joined him in his move. They joined six other gastroenterologists, and the group has grown to include three hepatologists, three physician assistants, a transplant coordinator and many research coordinators. “I wanted to establish a credible hepatology practice, including a hepatitis C and liver transplant clinic,” he said. “We collaborated with a transplant program, we’ve got joint appointments for the surgeons in our hospital, as well as appointments for us at the University of Maryland School of Medicine. We now have an active transplant clinic, and the transplant surgery is done at the university hospital. We handle pre- and post-transplant care. This year we established a state of the art endoscopy unit and started our ACGME-accredited gastroenterology fellowship program.”

Going Solo

Robert W. Reindollar, MD, of Piedmont Health Care, is a solo practitioner. He discussed day-to-day strategies for remaining economically viable over time. “A key to remaining viable is having a competent office staff, office manager and research department,” he said. “You should always think about growing your practice. In order to do this, you have to have an office manager who keeps office hours filled with new patients and knows how to navigate the health care laws.”

Another key component is visibility in community, according to Reindollar. He appeared on public TV doing spots about hepatitis awareness, trained residents at the Carolina Medical Center, delivered lectures for pharma and contributed in various capacities to local transplant centers. “I also initiated community projects to help train local clinicians in the community to be aware of and diagnose fatty liver,” he said. “This will comprise my patient population in the future.”

Keeping up with technology can pay dividends in landing research projects. “We bought a FibroScan machine,” Reindollar said. “We know that reimbursement is not good, but we have done over 800 scans, and it has proven to be a tool to get more research. A lot of companies conducting trials want someone to have access to a FibroScan.”

Reindollar added that conducting clinical trials has the dual benefit of generating revenue and maintaining visibility in the community.

Finally, any clinician going solo should keep in mind the reason many people avoid larger health care systems in the first place. “Never underestimate the power of the patient,” Reindollar said. “They will see the doctor they want to see, no matter who their primary care doctor refers them to. And today they can use social media to find you, help you, or, if they want, to hurt you.”

Partnering with a GI Practice

Using his experience as professor of medicine and hepatologist/gastroenterologist at the University of Minnesota and hepatologist/gastroenterologist at Minnesota Gastroenterology, a large, single practice gastroenterology group in the Minneapolis/St. Paul area, Coleman Smith, MD, offered insight into working as part of a gastroenterology practice. Smith is currently professor of medicine at Georgetown University and a hepatologist at MedStar Georgetown University Hospital Transplant Institute.

“Before a hepatologist joins a gastroenterology group, a number of questions need to be addressed,” he said. “Will you have to do any general gastroenterology? And if so, how much gastroenterology will you have to do? Will you have other physicians in the group who have an interest in hepatology? Will they do some of the liver clinics as well, or will you be the only one?”

He added that practical concerns like call schedule should be considered, as should nurse practitioner and PA availability. “Will you have the same access to these mid-level providers as the others in the group?” he said. “You may have to convince some of the gastroenterologists that perhaps hepatologists have a greater need for these nurse practitioners and PAs, given the chronic nature of most liver diseases and the amount of laboratory and radiologic data that needs to be reviewed.”

Smith discussed the amount of hospital coverage involved, and whether or not the group should undertake more difficult consultations. “Also, how much endoscopy would you do? Would you just do endoscopy on your own patients?” he said.

Smith stressed the importance of discussing the amount of hospital coverage that would be required. “Would this coverage include general gastroenterology or only hepatology? The hepatologist should ask whether or not the group would undertake any liver consultations or only the straightforward ones. How much procedural work would be required? Would you just do endoscopy on your own patients, or be part of the general rotation?” he said. Gastroenterologists in the practice may need to be reminded that the hepatologist would be able to see liver patients, thus freeing up the gastroenterologists in the practice to spend more time with procedural work. This should be factored into discussions of salary for the hepatologist, he added.

Before joining a community gastroenterology practice, if the hepatologist has an interest in clinical research he/she should find out if coordinators, budget managers and nurses will be provided for research purposes, according to Smith. “You should ask whether there will be the physical space to conduct clinical trials,” he said. “Will the infrastructure that you need to do trials be supported by the practice?”

Smith emphasized the fact that most liver diseases, including HCV, are chronic diseases that require ongoing and regular follow-up, which makes it necessary for regular clinic visits. “We have to review the laboratory results and imaging results. Nurse practitioners and PAs are necessary to participate in this process, as well as seeing patients in clinic and supervising their medications,” he said.

Paul J. Thuluvath

Various practices have different approaches to compensation, Smith explained. “Will everybody in the practice get an equal amount or will it be a mixed model based in part on productivity?” he said. The question of compensation has to be looked at up front.

“Before anyone joins any group, these questions need to be addressed. The hepatologist should decide what he/she wants and what is available,” he said.

Like anyone who works outside the system, Smith faced challenges. “During my stay in Minnesota, it took a while, but we could finally convince the gastroenterologists and the ‘bean counters’ that hepatology is part of gastroenterology and one can have a very successful, enjoyable and productive time in that sort of setting,” he said.

Working as Part of a Larger Health System

For Shiffman, who works for a health system, the care of patients with liver disease requires a lot of laboratory and radiologic testing. This creates significant down-stream revenue for the health system’s hospitals and is what makes having a hepatology practice within the health system attractive, he said. “Although our health system does not perform liver transplantation, we have been able to establish special relationships with several liver transplant programs in our area. This allows patients the ability to undergo all liver transplant testing, all pre-transplant care and all post-transplant care locally within our health system and hepatology practice,” he said.

Patients travel to the liver transplant program for only a few selected visits, in addition to the transplant operation. By keeping patients locally, the patient, the health system and Shiffman’s hepatology practice all benefit. “We are now caring for so many pre- and post-liver transplant patients that we have added specialized nurse navigators who coordinate all aspects of the pre- and post-transplant medical care and interact with the various liver transplant teams we work with on a daily basis,” he said.

Full commitment by personnel to follow up and contact patients with results to maintain the database is important, according to Benner. “There is some integration between the EMR and our database, but it’s not perfect,” he said. “Working across several health care systems makes it challenging. It is hard to keep everything up to date.”

Thuluvath raised even more practical concerns. “What are we going to do about the space, the number of dollies, the support staff, research coordinators?” he said. “It’s almost impossible to replicate a major academic center in a community hospital.”

Doing Research

In terms of conducting trials, Kris V. Kowdley, MD, from Swedish Medical Center in Seattle, first said that enrollment targets should be realistic. “I can’t understate the importance of a research manager with experience,” he said.

Every institution has a feasibility process, according to Kowdley. “It is very important to institute a clinical trials management system as soon as possible, and to inform your research manager to understand the cost of doing research at your particular facility,” he said, and reminded clinicians of institutional review board charges. He added that finding potential patients is something else to think about.

Despite these real concerns, Kowdley stressed that community centers have a lot to offer the clinical trials arena. “Sponsors are interested in a high enrollment and a short startup time,” he said. “That sometimes gives a non-university site an advantage.”

Beavers underscored Kowdley’s suggestion. “We have seen the benefits of community practice research,” she said. “In my time in private practice, turnaround for contracting and IRB routinely took 2 to 3 weeks. In my current position in an academic medical center, contracting and IRB routinely takes several months. Fast advances in therapies have made the drug companies want a faster turnaround time for research. Because of this, we have seen a big shift for savvy, pharma-driven research to turn to the community centers to carry out studies.”

The site qualification visit is also critical, according to Kowdley. “That’s where you really have the ability to engage whoever is the clinical operations person for that pharmaceutical company,” he said. “You should demonstrate to them that you have a system in place for being able to see the patients, process the laboratory samples, to have a good chain of custody for the samples — which is now more and more important as far as FDA inspectors are concerned — and confirm site selection early on so you’re not behind the eight ball.”

Familiarity with the financial and legal language of the business can lead to successful trials, according to Kowdley. Clinicians in charge of research should attend the investigator meetings and, most importantly, the site investigation meeting. “That is the visit that convinces your monitor that you are a hands-on supervising investigator who is not delegating key tasks,” he said.

Details, too, are critical, everything down to consent forms being signed by patients. And these details, ultimately, can have a big payoff. “Sponsors are willing to subsidize your studies,” Kowdley said. “There is the opportunity to participate in a study that has a potentially very high impact and could lead to a substantially impactful paper that would bring notoriety, fame or luster to your institution.”

Clinical Concerns

Most of the panel noted that positive clinical outcomes should be the focus, and that this is an achievable goal. They offered insight on everything from screening to liver cancer to building a transplant program.

Regular meetings are also part of the clinical approach for Thuluvath. “We started regular pathology meetings just like any academic center,” he said. “We wanted to consolidate our efforts. We started a satellite clinic and then we asked for a package appointment with the university.

In the long-term, we wanted to expand the practice and we wanted to start a training program, a fellowship in GI. We also wanted long-term commitment from the hospital.”

At Bon Secours, Shiffman and his partners offer a full range of transplant-related services. “We offer pre-transplant management, where we identify patients in need of transplant,” he said. “We initiate their evaluation, which can include cardiopulmonary tests, cardiac catheterization, we do all of their dental work, we recognize when patients need drug and alcohol counseling. This is initiated weeks or months before they go to the transplant center so that when they go, these issues have been taken care of locally.”

Follow-up care includes monitoring as needed and a number of clinical services. “We will do a biopsy for abnormal liver enzymes, we can stent bile duct strictures, adjust immunosuppression,” he said. “We monitor for recurring cancer.”

Gaining the trust of and ultimately working with a transplant program is essential, according to Shiffman. “We collaborate with four programs,” he said. “You have to make sure your care is up to snuff.”

There are advantages to being a free agent who deals with transplantation, according to Shiffman. “If someone turns down your patient, you can try to find another program to transplant,” he said.

With regard to liver cancer, Benner said that screening is an important component of his center. “We are encouraging primary care to take a larger role in screening in the future,” he said. “Resource commitment is key to a successful screening program and can yield early stage diagnosis and reduce mortality.”

The next step is diagnosis, which, at his center, is done by a multidisciplinary tumor board in the community. “Our board is well attended by hepatologists, surgeons, diagnostic radiologists, and we have links to the community and region,” he said, and added that a patient navigator is also involved. “Specific diagnoses are imaging based. Treatment is predicated on findings from the tumor board. We have medical radiation and oncology working with the hepatologist.”

Relationships with Patients

Beavers raised some practical points about clinical approaches and patient outcomes. “Community practice and academic clinical practice seem to be growing more similar in terms of approach to patient care and expectations,” she said. “Hospitals are consolidating, eating up practices. Academic centers are allying with community providers, and this levels the playing field. Innovative payment and delivery models are becoming a reality. We are seeing more and more price transparency.”

She added that increased public scrutiny and social media monitoring have proven beneficial for community centers. “There is a greater demand for patients and providers to provide coordinated, patient-centered care,” she said. “To accomplish this, you need to create models to provide the care you want to provide. Collaborative care has become the norm. Patients don’t necessarily feel the need to go to an academic center to get care anymore.”

Benner said that education in the community is an important component to building relationships with patients. “We are getting buy-in and support by using state epidemiology to educate people about the scope of HCC,” he said. “In Oregon, we have seen a fourfold increase in HCC over the last few years. About half is related to HCV. The mortality rate is about double the national average for HCV.”

Money Matters

All of this, of course, requires resources, from start-up costs to daily operations. “It is very important to recognize that the initial budget is a starting point,” Kowdley said. “Those of us that have been doing this for a long time know that you just have to work your way up the food chain, and that substantial effort goes into the startup cost.”

Finding the time and money to travel to investigator meetings can be challenging, as can finding ways to incentivize colleagues to go to those investigator meetings. “They are frequently on a weekend,” Kowdley said. “Are you going to pay them? Are you going to reward them by taking them out of call? These are the challenges that are not that obvious when you are in a university setting.”

Understanding the system and the numbers can go a long way in keeping projects alive. “Recognizing that budgets are negotiable and bringing in the sponsor when negotiations hit a roadblock can sometimes be helpful,” Kowdley said.

He concluded by saying that a benefit of incorporated research is that it can be a source of referrals that can differentiate the practice and diversify funding sources. But Beavers warned that the realities of the business can prove problematic.

“There is more risk these days, because lately professional fees have become stagnant,” she said. “Procedure income is declining. This means more pressure and longer hours.”

Making an Impact

“So what did I learn through all of this?” Thuluvath said. “One of the important things to understand is that your colleagues may not share your vision because they come from different fields. Sometimes there is pushback. They might say, ‘This is not a major teaching hospital. Why do you want to do it in a community hospital setting?’”

Beavers spoke to this point. “Our approach is very different from an academic center,” she said. “But when you work with people who have the same goals as you, you can align with them.”

“This is a commitment,” Shiffman added. “It does require additional time and personal investment.”

Reindollar built on this point. “Continue to invest in yourself and your practice,” he said. “As HCV trials are winding down, we are already looking ahead, doing extensive research in nutrition in patients with metabolic syndrome and NASH.”

For Kowdley, it is a matter of blending personal and professional satisfaction in a challenging environment. “The good old days when we had large grants from pharmaceutical companies and then we used the leftover funds to pay for our projects are completely over,” he said. “But at the same time, this can still be a source of intellectual satisfaction while you diversify your practice and keep going to work a little bit more fun or a little bit less painful.”

Kowdley added that investigators from community sites are making an impact in research, as well. “We are seeing them as first authors on major papers,” he said. “So you will have a seat at the table.”

The overwhelming number of patients seeking care for HCV is a strong argument for Benner. “We estimate that there are 95,000 patients with HCV in the state of Oregon,” he said. “We are treating between 1,000 and 1,500 per year in Oregon. At this rate, it will take 15 to 20 years to treat them all. If we want to substantially reduce the number of new cases of HCV-related HCC, we’re going to have to greatly expand our access to care.”

Disclosures: HCV Next could not determine if Benner had any financial disclosures at the time of publication. Kowdley reports associations with companies including AbbVie, Boehringer Ingelheim, Gilead and Ikaria. Beavers, Reindollar, Shiffman, Smith and Thuluvath report no relevant financial disclosures.

The pathway to a truly successful career in any kind of medicine, including hepatitis C virus, traditionally carried a clinician through a major academic health center. To put it bluntly, this is where the money is. With money comes the opportunity to participate in comprehensive and groundbreaking clinical trials, work in the best facilities with the best clinicians and, often, achieve the best patient outcomes.

But at the Liver Meeting last year, Mitchell L. Shiffman, MD, of the Liver Institute of Virginia and Bon Secours Health System, put together a symposium on community-based medicine that highlighted the risks and benefits of breaking away from academia. In short, it is feasible. In fact, according to most of the experts on the panel, it can lead to all of the types of success traditionally enjoyed by practitioners in the major academic health centers, and then some.

The session covered a broad range of topics, from incorporating the business to participating in clinical trials. “When I left academic practice, one thing that was important was providing transplant care locally,” Shiffman said. “This requires desire and commitment and dedication from you and your staff, but it has been incredibly rewarding.”

Many of the experts, including Kimberly L. Beavers, MD, MPH, assistant professor of Gastroenterology and Hepatology at the Medical University of South Carolina, spoke honestly about the ups and downs of stepping away from the system. “You have the opportunity to carve out what you want the practice to be,” she said. “You can do inpatient care, outpatient, transplant. There is so much variability. You can choose when you want to participate in clinical trials. Yes, the work-life balance can be a downside. The nights and weekends are a drawback. But these things are negotiable with planning.”

The symposium was long on the hardboiled practicalities involved in building a community program from the ground up. There was talk of budgets and staff, building relationships with patients and academic centers, and the nuts and bolts of the clinic and the lab. The experts addressed various types of ventures, from solo practice to partnering with a larger center to building a transplant program.

There are huge obstacles. According to Kent Benner, MD, a gastroenterologist with the Oregon Clinic, however, it is entirely possible. “The key to developing programs is collaboration,” he said. “We as members of liver care teams have considerable experience in collaborating with experts in many fields. Managing complex patients with our transplant experience puts us in good stead to set up these community-based programs.”

Taking the Plunge

Paul J. Thuluvath, MD, medical director of The Institute for Digestive Health and Liver Disease at Mercy in Baltimore, was entrenched in academia, first as a lecturer at the University of London and then at Johns Hopkins as chief of hepatology. “One day I decided that I had had enough of mainstream academia,” he said. “I thought about it for some time and ultimately decided that I may be able to do the same thing that I did at Hopkins in a community teaching hospital affiliated to the University of Maryland.”

Thuluvath did research on the hospital he was going to and sought advice from others who had left the system for that particular hospital. “I wanted to know whether they had been able to continue what they were doing,” he said. “After doing the initial research, I deliberated on the topic and had many discussions with the hospital before moving to a center like that.”

He stressed the importance of having a detailed plan before moving. “It’s a culture shock when you move to another hospital without all the infrastructure of a major teaching institution,” he said, and added that it is important to set up short-term and long-term goals and reassess them regularly. “You have to decide on your objectives. You also need to have a timeline for expansion and check whether the hospital shares your vision.”

PAGE BREAK
Mitchell L. Shiffman

Perhaps most important is negotiation with the participating hospital, Thuluvath said. “We had to have the minimal requirements clearly spelled out in the beginning. Give it in writing, budget items, support staff, everything. If it’s not written, it is very difficult to go back and say, ‘Look, you haven’t followed through on what you promised.’”

Thuluvath said that three senior clinicians he had worked with, including the clinical director of inflammatory bowel disease, director of therapeutic endoscopy and director of pancreatic diseases, joined him in his move. They joined six other gastroenterologists, and the group has grown to include three hepatologists, three physician assistants, a transplant coordinator and many research coordinators. “I wanted to establish a credible hepatology practice, including a hepatitis C and liver transplant clinic,” he said. “We collaborated with a transplant program, we’ve got joint appointments for the surgeons in our hospital, as well as appointments for us at the University of Maryland School of Medicine. We now have an active transplant clinic, and the transplant surgery is done at the university hospital. We handle pre- and post-transplant care. This year we established a state of the art endoscopy unit and started our ACGME-accredited gastroenterology fellowship program.”

Going Solo

Robert W. Reindollar, MD, of Piedmont Health Care, is a solo practitioner. He discussed day-to-day strategies for remaining economically viable over time. “A key to remaining viable is having a competent office staff, office manager and research department,” he said. “You should always think about growing your practice. In order to do this, you have to have an office manager who keeps office hours filled with new patients and knows how to navigate the health care laws.”

Another key component is visibility in community, according to Reindollar. He appeared on public TV doing spots about hepatitis awareness, trained residents at the Carolina Medical Center, delivered lectures for pharma and contributed in various capacities to local transplant centers. “I also initiated community projects to help train local clinicians in the community to be aware of and diagnose fatty liver,” he said. “This will comprise my patient population in the future.”

Keeping up with technology can pay dividends in landing research projects. “We bought a FibroScan machine,” Reindollar said. “We know that reimbursement is not good, but we have done over 800 scans, and it has proven to be a tool to get more research. A lot of companies conducting trials want someone to have access to a FibroScan.”

Reindollar added that conducting clinical trials has the dual benefit of generating revenue and maintaining visibility in the community.

Finally, any clinician going solo should keep in mind the reason many people avoid larger health care systems in the first place. “Never underestimate the power of the patient,” Reindollar said. “They will see the doctor they want to see, no matter who their primary care doctor refers them to. And today they can use social media to find you, help you, or, if they want, to hurt you.”

Partnering with a GI Practice

Using his experience as professor of medicine and hepatologist/gastroenterologist at the University of Minnesota and hepatologist/gastroenterologist at Minnesota Gastroenterology, a large, single practice gastroenterology group in the Minneapolis/St. Paul area, Coleman Smith, MD, offered insight into working as part of a gastroenterology practice. Smith is currently professor of medicine at Georgetown University and a hepatologist at MedStar Georgetown University Hospital Transplant Institute.

“Before a hepatologist joins a gastroenterology group, a number of questions need to be addressed,” he said. “Will you have to do any general gastroenterology? And if so, how much gastroenterology will you have to do? Will you have other physicians in the group who have an interest in hepatology? Will they do some of the liver clinics as well, or will you be the only one?”

PAGE BREAK

He added that practical concerns like call schedule should be considered, as should nurse practitioner and PA availability. “Will you have the same access to these mid-level providers as the others in the group?” he said. “You may have to convince some of the gastroenterologists that perhaps hepatologists have a greater need for these nurse practitioners and PAs, given the chronic nature of most liver diseases and the amount of laboratory and radiologic data that needs to be reviewed.”

Smith discussed the amount of hospital coverage involved, and whether or not the group should undertake more difficult consultations. “Also, how much endoscopy would you do? Would you just do endoscopy on your own patients?” he said.

Smith stressed the importance of discussing the amount of hospital coverage that would be required. “Would this coverage include general gastroenterology or only hepatology? The hepatologist should ask whether or not the group would undertake any liver consultations or only the straightforward ones. How much procedural work would be required? Would you just do endoscopy on your own patients, or be part of the general rotation?” he said. Gastroenterologists in the practice may need to be reminded that the hepatologist would be able to see liver patients, thus freeing up the gastroenterologists in the practice to spend more time with procedural work. This should be factored into discussions of salary for the hepatologist, he added.

Before joining a community gastroenterology practice, if the hepatologist has an interest in clinical research he/she should find out if coordinators, budget managers and nurses will be provided for research purposes, according to Smith. “You should ask whether there will be the physical space to conduct clinical trials,” he said. “Will the infrastructure that you need to do trials be supported by the practice?”

Smith emphasized the fact that most liver diseases, including HCV, are chronic diseases that require ongoing and regular follow-up, which makes it necessary for regular clinic visits. “We have to review the laboratory results and imaging results. Nurse practitioners and PAs are necessary to participate in this process, as well as seeing patients in clinic and supervising their medications,” he said.

Paul J. Thuluvath

Various practices have different approaches to compensation, Smith explained. “Will everybody in the practice get an equal amount or will it be a mixed model based in part on productivity?” he said. The question of compensation has to be looked at up front.

“Before anyone joins any group, these questions need to be addressed. The hepatologist should decide what he/she wants and what is available,” he said.

Like anyone who works outside the system, Smith faced challenges. “During my stay in Minnesota, it took a while, but we could finally convince the gastroenterologists and the ‘bean counters’ that hepatology is part of gastroenterology and one can have a very successful, enjoyable and productive time in that sort of setting,” he said.

Working as Part of a Larger Health System

For Shiffman, who works for a health system, the care of patients with liver disease requires a lot of laboratory and radiologic testing. This creates significant down-stream revenue for the health system’s hospitals and is what makes having a hepatology practice within the health system attractive, he said. “Although our health system does not perform liver transplantation, we have been able to establish special relationships with several liver transplant programs in our area. This allows patients the ability to undergo all liver transplant testing, all pre-transplant care and all post-transplant care locally within our health system and hepatology practice,” he said.

Patients travel to the liver transplant program for only a few selected visits, in addition to the transplant operation. By keeping patients locally, the patient, the health system and Shiffman’s hepatology practice all benefit. “We are now caring for so many pre- and post-liver transplant patients that we have added specialized nurse navigators who coordinate all aspects of the pre- and post-transplant medical care and interact with the various liver transplant teams we work with on a daily basis,” he said.

PAGE BREAK

Full commitment by personnel to follow up and contact patients with results to maintain the database is important, according to Benner. “There is some integration between the EMR and our database, but it’s not perfect,” he said. “Working across several health care systems makes it challenging. It is hard to keep everything up to date.”

Thuluvath raised even more practical concerns. “What are we going to do about the space, the number of dollies, the support staff, research coordinators?” he said. “It’s almost impossible to replicate a major academic center in a community hospital.”

Doing Research

In terms of conducting trials, Kris V. Kowdley, MD, from Swedish Medical Center in Seattle, first said that enrollment targets should be realistic. “I can’t understate the importance of a research manager with experience,” he said.

Every institution has a feasibility process, according to Kowdley. “It is very important to institute a clinical trials management system as soon as possible, and to inform your research manager to understand the cost of doing research at your particular facility,” he said, and reminded clinicians of institutional review board charges. He added that finding potential patients is something else to think about.

Despite these real concerns, Kowdley stressed that community centers have a lot to offer the clinical trials arena. “Sponsors are interested in a high enrollment and a short startup time,” he said. “That sometimes gives a non-university site an advantage.”

Beavers underscored Kowdley’s suggestion. “We have seen the benefits of community practice research,” she said. “In my time in private practice, turnaround for contracting and IRB routinely took 2 to 3 weeks. In my current position in an academic medical center, contracting and IRB routinely takes several months. Fast advances in therapies have made the drug companies want a faster turnaround time for research. Because of this, we have seen a big shift for savvy, pharma-driven research to turn to the community centers to carry out studies.”

The site qualification visit is also critical, according to Kowdley. “That’s where you really have the ability to engage whoever is the clinical operations person for that pharmaceutical company,” he said. “You should demonstrate to them that you have a system in place for being able to see the patients, process the laboratory samples, to have a good chain of custody for the samples — which is now more and more important as far as FDA inspectors are concerned — and confirm site selection early on so you’re not behind the eight ball.”

Familiarity with the financial and legal language of the business can lead to successful trials, according to Kowdley. Clinicians in charge of research should attend the investigator meetings and, most importantly, the site investigation meeting. “That is the visit that convinces your monitor that you are a hands-on supervising investigator who is not delegating key tasks,” he said.

Details, too, are critical, everything down to consent forms being signed by patients. And these details, ultimately, can have a big payoff. “Sponsors are willing to subsidize your studies,” Kowdley said. “There is the opportunity to participate in a study that has a potentially very high impact and could lead to a substantially impactful paper that would bring notoriety, fame or luster to your institution.”

Clinical Concerns

Most of the panel noted that positive clinical outcomes should be the focus, and that this is an achievable goal. They offered insight on everything from screening to liver cancer to building a transplant program.

Regular meetings are also part of the clinical approach for Thuluvath. “We started regular pathology meetings just like any academic center,” he said. “We wanted to consolidate our efforts. We started a satellite clinic and then we asked for a package appointment with the university.

PAGE BREAK

In the long-term, we wanted to expand the practice and we wanted to start a training program, a fellowship in GI. We also wanted long-term commitment from the hospital.”

At Bon Secours, Shiffman and his partners offer a full range of transplant-related services. “We offer pre-transplant management, where we identify patients in need of transplant,” he said. “We initiate their evaluation, which can include cardiopulmonary tests, cardiac catheterization, we do all of their dental work, we recognize when patients need drug and alcohol counseling. This is initiated weeks or months before they go to the transplant center so that when they go, these issues have been taken care of locally.”

Follow-up care includes monitoring as needed and a number of clinical services. “We will do a biopsy for abnormal liver enzymes, we can stent bile duct strictures, adjust immunosuppression,” he said. “We monitor for recurring cancer.”

Gaining the trust of and ultimately working with a transplant program is essential, according to Shiffman. “We collaborate with four programs,” he said. “You have to make sure your care is up to snuff.”

There are advantages to being a free agent who deals with transplantation, according to Shiffman. “If someone turns down your patient, you can try to find another program to transplant,” he said.

With regard to liver cancer, Benner said that screening is an important component of his center. “We are encouraging primary care to take a larger role in screening in the future,” he said. “Resource commitment is key to a successful screening program and can yield early stage diagnosis and reduce mortality.”

The next step is diagnosis, which, at his center, is done by a multidisciplinary tumor board in the community. “Our board is well attended by hepatologists, surgeons, diagnostic radiologists, and we have links to the community and region,” he said, and added that a patient navigator is also involved. “Specific diagnoses are imaging based. Treatment is predicated on findings from the tumor board. We have medical radiation and oncology working with the hepatologist.”

Relationships with Patients

Beavers raised some practical points about clinical approaches and patient outcomes. “Community practice and academic clinical practice seem to be growing more similar in terms of approach to patient care and expectations,” she said. “Hospitals are consolidating, eating up practices. Academic centers are allying with community providers, and this levels the playing field. Innovative payment and delivery models are becoming a reality. We are seeing more and more price transparency.”

She added that increased public scrutiny and social media monitoring have proven beneficial for community centers. “There is a greater demand for patients and providers to provide coordinated, patient-centered care,” she said. “To accomplish this, you need to create models to provide the care you want to provide. Collaborative care has become the norm. Patients don’t necessarily feel the need to go to an academic center to get care anymore.”

Benner said that education in the community is an important component to building relationships with patients. “We are getting buy-in and support by using state epidemiology to educate people about the scope of HCC,” he said. “In Oregon, we have seen a fourfold increase in HCC over the last few years. About half is related to HCV. The mortality rate is about double the national average for HCV.”

Money Matters

All of this, of course, requires resources, from start-up costs to daily operations. “It is very important to recognize that the initial budget is a starting point,” Kowdley said. “Those of us that have been doing this for a long time know that you just have to work your way up the food chain, and that substantial effort goes into the startup cost.”

Finding the time and money to travel to investigator meetings can be challenging, as can finding ways to incentivize colleagues to go to those investigator meetings. “They are frequently on a weekend,” Kowdley said. “Are you going to pay them? Are you going to reward them by taking them out of call? These are the challenges that are not that obvious when you are in a university setting.”

PAGE BREAK

Understanding the system and the numbers can go a long way in keeping projects alive. “Recognizing that budgets are negotiable and bringing in the sponsor when negotiations hit a roadblock can sometimes be helpful,” Kowdley said.

He concluded by saying that a benefit of incorporated research is that it can be a source of referrals that can differentiate the practice and diversify funding sources. But Beavers warned that the realities of the business can prove problematic.

“There is more risk these days, because lately professional fees have become stagnant,” she said. “Procedure income is declining. This means more pressure and longer hours.”

Making an Impact

“So what did I learn through all of this?” Thuluvath said. “One of the important things to understand is that your colleagues may not share your vision because they come from different fields. Sometimes there is pushback. They might say, ‘This is not a major teaching hospital. Why do you want to do it in a community hospital setting?’”

Beavers spoke to this point. “Our approach is very different from an academic center,” she said. “But when you work with people who have the same goals as you, you can align with them.”

“This is a commitment,” Shiffman added. “It does require additional time and personal investment.”

Reindollar built on this point. “Continue to invest in yourself and your practice,” he said. “As HCV trials are winding down, we are already looking ahead, doing extensive research in nutrition in patients with metabolic syndrome and NASH.”

For Kowdley, it is a matter of blending personal and professional satisfaction in a challenging environment. “The good old days when we had large grants from pharmaceutical companies and then we used the leftover funds to pay for our projects are completely over,” he said. “But at the same time, this can still be a source of intellectual satisfaction while you diversify your practice and keep going to work a little bit more fun or a little bit less painful.”

Kowdley added that investigators from community sites are making an impact in research, as well. “We are seeing them as first authors on major papers,” he said. “So you will have a seat at the table.”

The overwhelming number of patients seeking care for HCV is a strong argument for Benner. “We estimate that there are 95,000 patients with HCV in the state of Oregon,” he said. “We are treating between 1,000 and 1,500 per year in Oregon. At this rate, it will take 15 to 20 years to treat them all. If we want to substantially reduce the number of new cases of HCV-related HCC, we’re going to have to greatly expand our access to care.”

Disclosures: HCV Next could not determine if Benner had any financial disclosures at the time of publication. Kowdley reports associations with companies including AbbVie, Boehringer Ingelheim, Gilead and Ikaria. Beavers, Reindollar, Shiffman, Smith and Thuluvath report no relevant financial disclosures.