Hello, my name is Brett Fortune, and I'm the co-moderator for the program today of the Public Health Healthcare Delivery SIG-sponsored program entitled Patient-Centered Care, an Evolving Paradigm for Chronic Liver Diseases at the Liver Meeting Digital Experience. I'm excited to introduce my co-chairperson, Manisha Verma, who will be joining me on this excellent presentation and wonderful list of panelists. We'll start off with Dr. Verma discussing non-hospice palliative care, a key component of patient-centered care, followed by Dr. Miho Vermana, innovative care models in liver disease care coordination and multi-display teams, followed by Michael Fuchs, who will discuss NASH-specific models for screening and linkage to care. And then moving on to the second half of our program, we'll have Dr. Lynn Gerber start with the role of patient-reported outcomes in clinical practice, followed by Dr. Sumit Azrani, who will discuss the role of telehealth in improving patient-centered care for advanced liver diseases, and then conclude with Dr. Michael Volk, who will discuss value-based payments linked with patient-centered care. Hopefully by the end of this program, you'll have achieved the following learning objectives. Review the key components of patient-centered care for the chronic liver disease population and strategies to bring these components to routine hepatology practice. Discuss necessary changes to enhance patient-centeredness within routine practice. Describe ways that the emerging domains of patient-centered care can bring out positive changes not only in clinical services, but also patient outcomes. And as a reminder, for those that have questions during the program, our speakers will be able to address those questions if you place them into the chat area. We thank you again for joining us on this wonderful program. Hope you enjoy, and I will now hand over to Dr. Verma to start our first lecture. Thank you. Welcome, everyone, to the session on patient-centered care, and thank you, Brett, for such a warm welcome. The title of my presentation is Non-Hospice Palliative Care, a Key Component of Patient-Centered Care. I'm the Director of Research in the Department of GI and Hepatology at Einstein, and I'm highly interested in patient-centered outcomes research and innovative healthcare delivery models. So this is my disclosure slide, an overview of what we will talk today. Today we'll discuss briefly about the key elements of patient-centered care and focusing on non-hospice palliative care, the unmet needs of end-stage liver disease population, the role of non-hospice palliative care in the care of end-stage liver disease patients, and the ongoing PAL liver study, which is being funded by the Patient-Centered Outcomes Research Institute. So as we all know, the Institute of Medicine has laid down six key aims for delivery of care, and patient-centered care is one of the key aims. It really reflects the providing care which is respectful of and responsive to individual patients' preferences, needs, and values, and these three are key domains of palliative care, most recently actually called as the non-hospice palliative care, and ensuring that patients' values guide all clinical decisions. So this figure just shows the key domains of patient-centered care, where we have mission and values aligned with patient goals as one of the key aims. The care should be collaborative, coordinated, and accessible, focusing on physical comfort and emotional well-being involving patients and families, right from the beginning till the end, and being fully transparent with a faster delivery of information. So this slide shows the burden of end-stage liver disease patients. So the symptom burden in patients with end-stage liver disease is often underappreciated. As we see from the recent systematic review by Peng et al. that patients with end-stage liver disease suffer equally or sometimes more than patients with cancer or congestive heart failure. Not only the patients are affected because of their symptom burden, but also this impacts their quality of life, their economic well-being, their work productivity, and also adds to the caregiver burden. So discussing about the key domains of palliative care and why it is important for patients with liver disease. So given the high burden, there is an additional need for palliative care, which is also termed by supportive care or non-hospice palliative care, the early palliative care. The key domains included are physical symptoms, psychological aspects, advanced care planning, social and cultural issues, spiritual, religious values, and end-of-life care. So the disease understanding and prognosis is one of the key elements of palliative care, which is integrated early on. The traditional palliative care used to be only towards end-of-life, but now more recently palliative care has become an evolving specialty, which has gained more importance and has progressively grown over time. This early palliative care is also called the non-hospice palliative care. So in this table, you will see the key definitions of non-hospice palliative care, which have been more recently defined by the Center to Advance Palliative Care, or CAPC, and by the National Consensus Project Clinical Practice Guidelines. So this is actually specialized medical care for people with serious illnesses that is focused on providing relief from symptoms and stress from a serious illness. So the myths and facts about palliative care, which we all want to know and have been recently published by me and my colleague in the current treatment options in gastro, that palliative care, or for now, actually called non-hospice palliative care, can be applied to any patients with advanced serious chronic illness. On the other hand, hospice care is for patients with terminal illness and projected survival of less than six months. The goal is to really convey the information that palliative care can be conveyed to patients, can be delivered to patients who are already on treatment therapies as well. The fear among providers that if they refer a new patient to palliative care, the patient may think they are giving up is a myth. On the other hand, palliative care can be a benefit at any stage. It has a potential to improve symptoms, disease, prognosis, understanding, and even have advanced care planning early on. But historically, in the past five years, actually, many retrospective reviews have looked at the underutilization of palliative care for end-stage liver disease. I have highlighted two of them here, that palliative care is involved very late and has limited involvement in case of care for patients with end-stage liver disease. Most recently, actually, Bounds et al found that only 19% of decompensated patients received palliative care with hospitalization costs significantly reduced in those with early palliative care because of a lower number of endoscopies and blood transfusions. The literature has also focused on barriers to clinical integration of palliative care, particularly non-hospice palliative care. For example, providers and patients both have preconceived notions of equating palliative care to end-of-life care. There is preferential focus on treatment and not on the other quality-of-life burden. There is discomfort to discuss among the providers due to lack of training on such communications. There are other competing demands in clinical settings. There is limited access to palliative care services given the limited workforce, limited reimbursements for providing palliative care, and inadequate communication about goals of care. So certain key steps which we think can help integrate non-hospice palliative care within end-stage liver disease care includes provider education as one of the key components and the first component which needs to be addressed. All the hepatology providers need to be fully familiarized with certain primary basic skills of palliative care so that they can integrate those within their routine clinical practice. Universal use of prognostic tools and screening instruments for symptoms, depression, and distress can serve as their toolkit. We need to develop some clear criteria for palliative care referrals and include goals of care and advanced care planning discussions within routine care, including transplant evaluation, since the outcome of transplant evaluation is either cure or no cure, so which we do not know up front. So it's important to integrate these kinds of discussions to begin with and support caregivers during their journey with patient sufferings. So now I'm going to discuss the PAL liver study, which is the palliative care for end-stage liver disease patients, a multi-center study funded by the Patient-Centered Outcomes Research Organization Institute. It's a multi-center cluster randomized controlled trial comparing two models to offer palliative care to improve quality of life for patients with end-stage liver disease. We randomized VA sites versus non-VA sites into two models within their each cluster. Model one is the consultative palliative care arm and model two is the hepatologist-led palliative care arm. In model one, the patients are able to receive palliative care from the palliative care providers who are both certified. And in model two, the hepatologists who have undergone certain training to deliver primary palliative care, they are the ones who are delivering palliative care over time. The study involves four intervention visits and is currently in the recruitment phase. The primary outcome is quality of life as assessed by FACT-TEP. Secondary outcomes include symptom burden, depression, distress, satisfaction with care, caregiver burden, caregiver quality of life, goal-concordant care, and healthcare utilization. The protocol has been published for more details into that. So as a part of the study, the intervention, the good part is that both models are delivering palliative care, so any patient who is participating in the study has the benefit to receive these additional services. Both models receive this palliative care based on the ASCO ambulatory palliative care guidelines. Intervention applies to patients and caregivers as a dyad. The ESAS, which is Advent and Symptom Score, Depression Score, and the Distress Thermometer are used as the intervention toolkits in the hepatologist-led model. The key components include patient's caregiver understanding of diagnosis, illness, and prognosis so that the providers are discussing these things in more detail and making sure the patients understand it, symptom assessment, psychosocial assessment, distress screening and management, discussions of goals of care, and advanced directives. These are the key elements of the intervention. So this figure, the map of America, shows the network for palliative care. We have currently 18 recruiting sites. Duke Clinical Research Institute is our data coordinating center, and Einstein is the main hub for putting all the grants together. And we are looking forward to the results. They are still under recruitment. So this table shows the palliative care always hepatology's key modules, which were developed in collaboration with Stanford's online learning platform and the people at Stanford who are palliative care experts. So these key domains. Each module has its own, you would say, lectures and assignments, and currently the abstract is being presented at AASLD's poster presentation, where we have described more details. Given the sake of time, I will move on quickly and complete my discussion with key takeaways that non-hospice palliative care is really about aligning treatment with the patient's goals and values, and can potentially improve symptoms and quality of life. It does not equate hospice care, it is relatively independent of prognosis and can be offered concurrently with curative treatments, such as transplant evaluation. Educating hepatology providers on non-hospice palliative care principles can help overcome the access and limited workforce barriers. Ongoing research will find some evidence which can improve practice, further research must continue to evolve this field. Thank you so much, and I hope you enjoy the rest of our session on palliative care and other key elements of patient-centered care. Good afternoon, fellow AASLD attendees. My name is Mayor Bermania. I've been asked by the organizing committee, and I'd like to thank the organizing committee to talk about innovative care models in chronic liver disease. Currently an assistant professor of medicine at Western University in London, Ontario, Canada, and after attaining a master's in public health from the Harvard School of Public Health, I will also hold advanced certification in quality improvement of patient safety. Currently focus my research around quality improvement initiatives to advance and standardize quality of care in patients living with liver disease. Here are my financial interest disclosures over the past 24 months. I've had grants and research support from Merck and Allergan, and then received speaking fees from Roche, Merck, EyeSight, as well as AbbVie. None of these companies had any input in the current talk that I will be giving to you today. So first, before we talk about innovative care models, we really need to ask if we really need specialty care access for chronic liver disease patients. Our patients are unique and very complex, and we know that it's very costly. In terms of the burden of liver disease, we know that it's increasing globally due to NASH as well as alcohol-related liver disease incidents rising. We also know that HSE is increasing at a rapid pace, along with these other etiologies of liver disease. We know that chronic liver disease is associated with high mortality, if not eligible for curative therapies, and even if you are eligible for curative therapies, we know that these can be expensive endeavors. Chronic liver disease often have high admission rates, as well as readmission rates up to 70% in the papers that I've shown below. And then we also know that chronic liver disease affects other health-related quality of life domains that are very important to patients. And so yes, we do need specialty access to GI and hepatology, but does it improve any outcomes? And this paper from Dr. Mellinger actually shows that if you have access to GI and hepatology care, it's actually associated with improved survival, as well as adherence to quality metrics. So what are the current barriers or unmet needs about specialty access? Well, we know that a lot of the clinical models for predicting mortality, such as our MELD score, can be inaccurate in terms of defining mortality and have poor discriminant function. We know that there's a dearth of hepatologists across North America, and this is especially pronounced in rural and underserved communities. Our patients are unique in that their social determinants of health are affected more than the general populations. And really, we know that our patients need a multimodal and multidisciplinary team to care for their unique needs. And so what are some of the models that we can adapt and institute in patients that we're taking care of on a day-to-day basis? One of these models are the multidisciplinary team models, which you may have heard of already. So MDT, or multidisciplinary teams, require at least two healthcare workers from different professions working together with patients and caregivers to achieve coordinated care. MDTs are really standard of care for a lot of cancers, such as breast cancer and gyne cancers, and also used in chronic care models, such as COPD and heart failure. We know that MDTs in liver care, when you look at these specific domains, when you look at hepatocellular carcinoma, we know that it can lead to improved survival as well as shorter wait time for treatment. For alcohol-related liver disease, we know that involving an MDT team prior to transplant, involving them peritransplant as well as post-transplant, we can reduce the rate of post-liver transplant recidivism. We know in chronic liver disease, we can reduce hospital readmissions as well as mortality. And then NAFLD, which is a growing public health problem, these MDT clinics can help integrate endocrinologists, bariatric surgery team members, as well as metabolic endoscopy to provide this well-rounded care for patients. We know that there's benefits to the patients. So there's reduced testing, there's improved communication, and it allows the patient to come away with an integrated plan or a so-called one-stop shop for their treatment. To the physician, there's shared decision-making and access to best available treatments in a field that you may not be familiar with. You have access to evidence-based medicine. And to the system, there's obviously cost savings due to streamlined care that we're providing these patients. So what are some other models of care that we can adapt? Well, there's also chronic care models, which are slightly different than the MDT models that I just talked about. And again, these are used in COPD, heart failure, diabetes, as well as inflammatory bowel disease, and starting to come about more in liver care. And what the chronic care model is, is to aim to provide a multimodal treatment aspect of a patient's care. And I'll get to that in a second. But again, it does meet the triple aim. It improves individuals' experience of healthcare. And we know this by looking at patient-reported outcomes. We know that it improves the health of population, and we know that it also reduces the cost of care in these patients. And so what does a chronic care model mean? Well, really, when you look at traditional care models of what we have right now, we have a center of excellence that's built around the healthcare team. So we have a patient that comes to us to get their healthcare addressed. Whereas in the chronic care model, the patient stays at the home, and we surround the patient with the necessary infrastructure. The traditional center of excellence, we have the hepatology as the consultant with the referral from a primary care physician. Whereas in the patient-centered care model, we're working with the healthcare, and we're looking at a holistic view of the patient. With that being said, the focus becomes wider. We're providing better quality. We're engaging in preventive medicine, and then we're also using other resources that are at our disposal, such as telemedicine. And the hope that is that the remuneration changes as well, too, as insurance companies realize that you're providing higher value care for these patients at a reduced cost. But what are some challenges with these models? Well, the optimal patient population is not yet defined. Are we going to involve a patient with F1 fibrosis who has NAFL in these models, or are we going to select two more complex patients who are compensated cirrhotics who we know are high hospitalizers? What are the payment models that are going to come out of this is yet to be determined. And then preventing team burnout. Right now, we take an individual care of the patient, but now as we involve the whole team, how can we prevent team burnout? And then also longitudinal care. So if a patient moves from one city to another city or across states, how can we adapt these models to different areas of the patient's living conditions? And so with MDT rounds, chronic care models, we also have telemedicine. And a lot of this has been propulsed into action because of COVID-19, but really what telemedicine, broadly speaking, is the delivery of healthcare services from a distance by the use of telecommunications and virtual technology. And telemedicine can occur in three ways. Teleconsultation, so we know about the ScanEcho project that Dr. Arora led in New Mexico with his hepatitis C patients. We can have televisits, so the patient has contact with physicians in another location. And then telemonitoring, where the provider-to-provider consultation with the patient in the room. So we have three patients, three people in the room virtually. And so does it work in chronic liver disease? Well, yes, it does. So in HCC, we know that surveillance patterns are better. We know variceal screening patterns are better in telemedicine. We know that telemedicine can improve access, and especially for transplant wait times, we can reduce the time for assessments. We're providing value-based care, and then we're, of course, alleviating hospital visits, especially during COVID-19. But what are some barriers to telemedicine? Well, of course, we lose that patient-physician relation. We have the touch, the feeling, the simple greeting of a handshake has profound interaction with your patient. We are still struggling with infrastructure, especially those patients that are unable to access or use technology, such as our elderly patients, or those that are socially disadvantaged. And then federal and state regulatory and reimbursement limitations. This was prior to COVID-19, where less than 20% of people were using telemedicine, but due to CMS lifting certain restrictions, we know that telehepatology has greatly expanded, and Dr. Estradi will talk about that on his talk. We also know that there are some candidates that are not optimal for telemedicine. So if you had recent decompensation, or if there's some worrying signs or symptoms, you may require an in-person visit. The liver transplant evaluation can get complex. There's multiple meetings with social worker, dietitians, frailty indexes that you may be using. And then of course, building rapport, as we know that liver transplantation can be a rollercoaster. And so establishing that rapport early on could be missed with telemedicine. And then of course, end of life discussion may not be best done over the phone or telemedicine. And so future directions are, how are we gonna upscale this and integrate telemedicine and routine care? And I think about the airline industry, where we have hub cities where all major airlines are flying in, and then subsequently they fly off to smaller cities or other airports in the vicinity. We talk about education and development of skills, of trainees, of staff for conducting telemedicine. We haven't gotten really much expertise in this. We've been put into a situation with COVID-19, but there's still a lot to learn on how to conduct a history and physical proper etiquette on telemedicine. And then we need to determine who the right population is gonna be to study and optimize patient-centric care. So I wanna conclude this talk by saying that our patients really require a village to improve their outcomes. They're very sick, they're multimodal, they're high utilizers of care. But COVID-19 has really mobilized us to utilize, establish ways of how we deliver care to our patients, specifically tele-hepatology. And I should mention that MDT rounds, chronic care models, tele-hepatology, they've been in practice for quite some time, but now we've really been thrust into action by COVID-19. And we must remember that it improves care costs as well as outcomes in our patients. So thank you for listening. I'd be happy to take any questions that you may have. I want to thank ASLD for giving me the opportunity to talk about NASH-specific models for screening and linkage to care, a veteran-centered perspective. This is my disclosure and disclaimer slide. Non-alcoholic fatty liver disease, or NAFLD, is an umbrella term for steatosis or non-alcoholic fatty liver, NAFL. And non-alcoholic hepatitis, NASH, a liver disease with histologic features of steatosis, ballooning, and lobular inflammation as displayed, and which can progress to cirrhosis and liver cancer. NAFLD certainly has become the most common chronic liver disease. The NAFLD disease burden is enormous. 25% of the general population, as shown on the left, has fatty liver disease, and 4% have NASH. Of note, one of two patients with type 2 diabetes has NAFLD, and NASH is almost 10 times as common in diabetics compared with the general population, making diabetes the main player in accelerating liver fibrosis and associated mortality. Looking at the U.S. veteran population, an estimated three million in care have NAFLD, and more than 500,000 have NASH with advanced liver fibrosis, including liver cirrhosis. It is thus not surprising that NAFLD poses a large economic burden for the Veterans Health Administration as one of the largest healthcare systems in the United States. Earlier this year, WorkFromNashNet, a consortium of U.S. centers of excellence for NAFLD care, including my own institution, has demonstrated that screening patients with type 2 diabetes is cost-effective. This underscores the updated guidelines of the American Diabetes Association that recommended to screen diabetics for NAFLD. Updated ASLD guidance should revise current screening recommendations with new evidence available. When we talk about screening, we need to remember liver biopsy is currently the only modality to distinguish between steatosis and NASH, but several non-invasive tests have been evaluated. Please note, screening tests must facilitate the distinction between presence or absence of advanced liver fibrosis. This slide illustrates our current toolbox of non-invasive tests or NITs to detect liver fibrosis. The tests can be broadly categorized into blood and imaging biomarkers. Blood tests are either commercially available, patented tests, or cheap and widely available. The best validated non-patented test is FIB4. It can be calculated using an app or automatically by the electronic medical record system. FIB4 is calculated using ALT, AST, platelet count, and age. Contrary, imaging tests evaluate for steatosis and liver stiffness as a surrogate marker for liver fibrosis. Transient elastography or FibroScan is the best studied imaging modality next to MR elastography. However, there is limited availability of these tests in the primary care setting. This slide displays the NAFLD care goal as shown on the right, and as a complex disorder involving multiple organs. Our care plan has to be inclusive, not only of the liver disease, but also of comorbidities and the individual needs of a patient. In an optimal setting, this will be done with a NAFLD care team composed of a hepatologist, nurse practitioner, nurse, dietitian, and a clinical pharmacy specialist addressing medications for diabetes, dyslipidemia, hypertension, and weight loss. Now let's move from the ideal to the real world setting. This slide displays the strengths, weaknesses, opportunities, and threats of our current fragmented NAFLD care we provide to veterans and NAFLD patients in general. Of note, VA has gained great experience with population health management to almost achieve hepatitis C elimination, and has broad availability of noninvasive fibrosis tests such as elastography. On the other hand, access to specialty care is often limited and integration with other subspecialties is absent. Let's have a closer look how we currently deliver NAFLD care. The four major areas of NAFLD care delivery limitations are shown on this slide. First, patient awareness. Education is paramount for a disease silently progressing, and patients need to understand the roles of different providers in their care. Second, primary care. There's a large number of patients at risk and undiagnosed with liver disease being dwarfed by other chronic disease management mandates. Third, access to specialty care. There is not only a limited number of specialists, but they are also concentrated in urban areas. Finally, care coordination. There's poor coordination and communication among primary and specialty care and among specialties, as well as a lack of proper tracking of patients. Why should we improve on those deficiencies in NAFLD care? Establishing a NAFLD care referral pathway will benefit the patient by minimizing the risk to silently progress to advanced liver disease, getting access to emerging therapies, receiving targeted screening for complications of advanced liver disease, and avoiding unnecessary inconvenience and anxiety. Specialty care benefits will reduce unnecessary referrals and allows us to focus on those with clinically irrelevant disease. And finally, there is an economic benefit as unwarranted costs will be reduced. Now let's look at the present primary care engagement in NAFLD. This is characterized by minimal provider and patient education, large number of patients, but limited available time. PCPs not being incentivized to look for a NAFLD. If primary cares are looking, they do not see. Lack of best clinical practice guidance and limited resources to support NAFLD. This clearly highlights that we need to train PCPs to the task as displayed on the right. NAFLD must be recognized as population health priority that no longer can be devolved by other chronic disease management mandates. We need ongoing provider and patient education and risk-based case finding in high risk groups. Have PCPs perform appropriate fibrosis risk assessment and establish locally adopted referral pathways to specialty care. Now let's look next closer how we can become better with regards to linkage of care to the specialist. One possibility is a one-step referral pathway in which the PCP utilizes a single non-invasive test or NIT with a defined cutoff that triggers referral to specialty care. An alternative is to have the PCP utilize two tests to decide if a referral to specialty care is appropriate. One also can use a two-step referral pathway in which a first NIT is done to rule out a larger portion of patients that do not need specialty care, followed by a second NIT chosen based on local availability and that determines the necessity for a specialty care referral of those patients not excluded by the first test. A variation of sequential NIT use is displayed at the bottom. In this scenario, a provider from specialty care serves as a gatekeeper to determine the need for a second NIT and subsequent referral to specialty care for further workup. Such a scenario is applied at my own center and illustrated on the next slide. Primary care utilizes FIP4 as a first NIT. FIP4 is automatically calculated and reported by the laboratory. An e-consult for chart review is placed for those that warrant further exploration, in this case, if the FIP4 is greater than 1.3. After chart review, the patient is scheduled for vibration-controlled transient elastography or VCTE FibroScan as a second NIT. Only those with a liver stiffness above eight kilopascal would be referred to the liver clinic for further workup and management. In implementing a better care model for an FLD, we also need to address limited resources available to a healthcare system. This slide lists some examples how we can address settings with limited resources. We need to expand and train the current workforce, establish a specialty care access network for an FLD similar to that one created for hepatitis C, increase the utilization of internet-based video conferencing with patients and providers, and develop regional centers of excellence for an FLD. This then leads us to a more widely applicable patient-centered and FLD care model. In this model, a comprehensive patient assessment is performed first. Following collection of all relevant information, an interdisciplinary group of providers is developing an intervention plan that addresses not only the liver disease, but also all comorbid conditions. Following the intervention phase, the patient then is reassessed and the intervention either continued without changes or a new intervention plan is put together. In closing, I want you to remember the following take-home messages. First, an FLD must become a population health priority for primary care. Second, optimal risk stratification in primary care is essential to deal with the large FLD population. Third, access to specialty care must be improved. And fourth, establishing interdisciplinary care models are desperately needed to provide better care for our patients with an FLD. It is up to us to make a real difference in the lives of our patients. Let's start and get this done. I know we can do it. Thank you for your attention. Hello, everyone. I'm Lynn Gerber, and I will be presenting a talk today on patient-reported outcomes, links to objective measures. I want to thank the organizers for inviting me and offering me this opportunity to discuss this topic. This is my conflict of interest statement. And I want to introduce my biases, which are that the goals of healthcare are certainly longevity, mortality, but also happiness, wellness, low levels of morbidity and function. And patient-reported outcomes will be addressing issues of function particularly today. ICD-11 is coming down the pike, and they will be requiring that we include as part of our routine medical evaluation measures of PROs and functional outcomes. What we mean by that is that one takes a history and identifies the patient's situation in terms of risk factors, which contribute to health conditions, but also the impact of the health conditions and its treatment on person's functioning, impact on their personal goals in terms of what they need and what they wish to do in their lives. Here, I'm identifying the list of things that are likely to be included in the ICD-11. And here you'll see associated features and comorbidities as known and relevant, specifically the associated physical symptoms and medical conditions, and those things that may, in fact, have functional limitations and restrictions on activity. Very important that we are aware of these and we'll include them in our evaluations going forward. What do we mean by patient-centered outcomes? Well, patient-centered outcomes research has defined its content in terms of the benefits and harms of interventions to inform decision-making and highlighting outcomes that matter to people. One needs to include the preferences of autonomy and patient preferences, focusing on outcomes that people really care about, certainly survival, but function, symptom burden, and quality of life. There are a wide variety of settings and diversity of participants who need to be included in these evaluations, including outpatient, post-acute care, acute care settings, all of which are part of patient-centered outcomes. And while addressing burdens to individuals, one has to also include information about the availability of services and their accessibility, technology and personnel, and other stakeholder perspectives. Function is usually a patient-centered outcome. It's defined as a dynamic interaction between health conditions, environmental conditions, and personal factors. It's usually a mixture of both objective and patient self-reports. The World Health Organization defines it in terms of an interactive model that includes important information about structure and function in the body, anatomy, physiology, the activities of the individual, participation in society, including work, school, and other social interactions. And these are all influenced by health conditions, environmental factors, and personal factors, all of which are taken into account in evaluating the impact of illness on an individual's general activity. The general characteristics of patient-centered outcomes or patient-reported outcomes is that we are trying to add a modicum of order and reproducibility to these instruments. Adding rigor and data to anecdote is one of the outcomes sought, and getting beyond expert opinion to evidence-based outcomes, which has necessitated making sure that the psychometric properties of these tests are really very reliable. They must be reliable and sensitive, valid and new kid on the block, contextually relevant. The desirable features of PROs are low burden of test in terms of time, privacy, and morbidity, that they utilize domain-specific measures, including the ones I've just outlined. Physical activity might be one, social participation, attendance at work and school might be others, and utilizing specific measures so they are relevant to outpatient home and community settings, and that they are stage-specific in terms of whether or not they're addressing issues pertaining to mortality, disease activity, disability, or overall health, and use culturally sensitive measures. Most patients who are completing PROs will have some communication about the following symptoms. Frequently, these are the things that drive patients to seek medical advice, pain, fatigue, stiffness, weakness, sleep disruption, functional decline, vocational and school difficulties, avocational difficulties, personal and social factors, cosmesis, appearance, and then mood and psychological impact. Some of these things can be objectively measured, but others really do require the individual to report them to you via questionnaire or through an observed assessment. The direct measures that are likely to meet the PCOR definition include activities of daily living or instrumental ADLs, that is, the ability to complete a check, make your appointments, attend your appointments, and require a higher level of cognitive ability and mobility and activity. These are usually objectively measured, but they certainly can be self-reports and they're very reliable. Functional capacity evaluations and cognitive performance are often observed or objective measures as well, and these are clearly relevant to people's functional and general activity. However, we infer from a number of objective measures what is likely to influence an activity. For example, if your walking speed is high, you're very likely to be a community ambulator. If you're walking at less than 150 yards per minute, you are likely to be homebound or perhaps just outside of your house. These other measures, grip strength, timed up and go, functional reach, cognitive performance, often correlate very, very closely to the patient-reported outcomes. So that's why we call them indirect measures, but they have great value in part because they're relatively easy to administer and they are objective. Patient-reported outcome measurement information systems was funded by the federal government in an effort to take the myriad of questionnaires, reduce them using a computer-assisted technique to those kinds of questions that could be used in a widespread application across multiple domains of function and patient reporting. They're highly reliable, they are precise, and they are very valuable in terms of identifying self-reported health status for physical, mental, and social well-being. The good news is that you can often use just a few questions, and so you lower the burden of assessment even more than standard questionnaire batteries asking multiples of 10 kinds of questions. They have been validated and they have been demonstrated to have very strong psychometric properties. The CLDQ, CLDQ-NAFLD, or CLDQ-HEP-C is one such patient-reported outcome that has been used very widely internationally for the evaluation of patients with chronic liver disease. Happy anniversary. It's been in business for 20 years and it is alive and well translated into multiple, multiple languages. It was constructed using a multi-domain model very similar to the SF36, and it was an effort mounted by Dr. Zobair Younassi with the assistance of Dr. Gordon Guyatt at McMaster University. Its psychometric properties are extremely strong and it has been used widely. The six major factors in the CLDQ are abdominal symptoms, fatigue, systemic symptoms such as weakness, fever, etc., physical activity level, emotional status, and worry. Of course, this is a self-report, but interestingly enough, if one were to look at the domains that have been used for CLDQ and also SF36, fatigue, systemic symptoms, emotional health, activity, worry, and abdominal symptoms, they are highly correlated with objective, in fact physiological, and blood levels. Activity level is highly correlated with fibrosis, and so I'm making the case here that even though there are self-reports, these are correlated with objective measures that could be used as a biosignature and a potential physiological outcome that you could define and associate with physical activity, for example, level of worry, or emotional health. The red demonstrates the most impaired patients, the orange the patients who are impaired, and the least impaired are those in blue. This was published by Yamamora in 2020. Other examples of relating self-reports to physiological or objective measures are shown here in this slide. If you look at the bottom two lines, CLDQ fatigue measure and CLDQ systemic symptoms, they correlate very well with the presence or absence of a normal baseline diastolic, so fatigue indicates a difference between a normal diastolic resting blood pressure versus a hypertensive diastolic blood pressure, as does systemic symptoms, so a self-report of symptom correlates with a defined difference between normal and abnormal blood pressure. Grip strength is another example of an objective measure that can be used to help understand relationships between function and performance. Grip strength is an objective measure. It's been standardized for gender and age by decade, very easy to administer, and the dynamometer itself is really quite reasonable in price. How has grip strength been used? It's been used in a variety of settings, but a recent one, which was performed in an epidemiological study called the Prospective Urban Rural Epidemiology Study, large longitudinal population in 17 countries enrolled people age 35 to 70 and basically did repeated measures of grip strength over four years. They found it had predictive value for all-cause mortality, for hospital admissions and readmits, for pneumonia or chronic obstructive pulmonary disease, or an acute respiratory disease, and predictive for injury due to fall and fracture, so a grip strength had predictive value for all-cause mortality plus other hospital-related or frailty-related findings. In a study looking at correlation between grip strength and NAFLD, Meng et al. demonstrated a study of a large cohort of adults in which they assessed grip strength with respect to the prevalence of NAFLD. They used three models. Model one here demonstrates the crude odds ratio of the relationship between the lowest level of grip strength to the highest level of grip strength. Model two looked at the same question but adjusted for age, sex, and BMI, and model three looked at the same question of prevalence adjusted for alcohol consumption, diet, education, and work status. They looked at the group that had normal ALT and abnormal ALT, and in both groups they demonstrated a lower prevalence of NAFLD by ultrasound was associated with higher grip strength, and that was quite statistically significant. Snead et al. took a slightly different view of whether or not grip strength could give important self-reported information, and the answer to that is yes. They looked at the relationship between grip strength and self-rated physical attractiveness and sexual history in a population of 145 male university students, and hand grip was genetically associated with height and weight but also with a variety of self-perceived views of happiness, health, social confidence, as well as physical fitness. Additionally, self-report of activity correlates very well with objective measures of metabolic equivalence of energy expended, diastolic blood pressure, activity monitoring using any of the commercial brands, and VO2 max, so self-report plus physiological determination of activity correlate very well. I hope I've made the case that there is value in using PROs to assess your patients and also that this correlates well with objective measures, the properly selected ones, and I believe PROs and functional measures are very important parts of health care, both in terms of their predictive value but also in terms of identifying what is important and valuable to patients. The ICD-11 is coming in January 2022. It will require functional and PRO assessments, so act now and learn about what's useful to patients. These assessments can be either self-reports or even objective measures correlating with the self-report may be substituted when you want specific quantitative information, probably not substituted but certainly can be used adjunctively and also relate to the value of using an objective measure for repeated measure as a patient outcome. Grip strength is an excellent surrogate for function and mortality, and self-reports of activity can be converted into quantitative measures that correlate very well with physiological parameters of fitness. Thank you very much for your attention. Thank you again for this kind invitation to discuss the role of telehealth in improving patient-centered care for advanced liver diseases. My name is Sumit Asrani, and I'm a hepatologist at Baylor University Medical Center in Dallas, Texas. I want to discuss three different aspects of telehealth. One, can it help us reach the rural and underserved? Two, can it help us individualize care? And three, can we effectively integrate telehealth in cirrhosis care? We tend to use the words telehealth and telemedicine interchangeably, but these are more umbrella terms to describe different ways of providing care. On one hand, there's televisits, which all of us are familiar with in 2020, where it's a physician with a patient. Two is tele-supervise, where it might be a provider helping another provider. Three is tele-monitoring, as may be seen in management remotely of ICU patients. Four is tele-consultation, which historically is a specialist providing care to multiple primary care providers. And then finally, tele-interpretation, which is services such as pathology and radiology that we're used to. Now, 2020 was a difficult year and continues to be a difficult year. What we initially saw was a rapid decline in patients with cirrhosis coming to the inpatient setting as compared to 2019. We also changed the way we provided care, as shown in the right panel. In blue, the in-person visits decreased, and there was a rapid uptake in tele-visits in 2020. With these new tools, the question is, can we improve access to care? Can we reach populations that we were not able to effectively in the past? Project ECHO sort of led the way with regards to treating the underserved. In its seminal study, this showed that it was effective to treat hepatitis C through our primary care providers, and that was with more difficult treatment in the past. This is an example from Baylor in Houston and St. Luke's, where Dr. Kaderi and Dr. Sussman have treated over 2700 patients through 300 clinic visits for hepatitis C. The target is rural and underserved. The different aspects of treatment include case-based coaching, because what we're trying to do is democratize knowledge across partner providers, whether it's MDs or PAs or NPs, expand access to care, keep care local, improve overall outcomes, and also have a mechanism built in for appropriate and early referral for the high-risk patient. Even in the VA setting, virtual consultations through the VA Scan ECHO project have been found to be useful. In this one study, looking at those patients that were seen virtually through a mechanism through the VA Scan ECHO project, there was improved survival and higher use of preventive services in the rural and underserved. Even in the prison system, this is an example of providing telemedicine for hep C therapy in the Department of Corrections, and across a variety of treatment regimens, there was high achievement of SVR in over 800 patients. Co-managing with the community program. In this example, led by the University of Pennsylvania group, and sort of defining tele-hepatology, where you had a community-based GI practice, which in concert with the hepatologist, allows for taking care of patients remotely that have decompensated cirrhosis, liver-related hospitalization, or those that need a second opinion for advanced liver disease. And in this pilot study, it was felt to be feasible for referring patients being scheduled to proceed with video visits. Clinical recommendations were incorporated with regards to testing order, medication changes, transplant referral. This was accepted by patients as well as by providers, and there were some barriers that were identified that we will discuss in a little bit. Even in the hospital setting, there was the sicker patient, the decompensated cirrhosis patient, looking at red, which shows tele-health, and black, which shows the usual care. Tele-health, as compared to standard of care, was associated with a shorter time to evaluation, shorter time to listing, and a non-significantly shorter time to referral to transplant. And the benefit was felt to be seen in patients that were low melt. With those broad strokes, the question is, can we also add a second element to individualized care through remote monitoring? And there's been some fantastic work that has been done over the last few years in this. Remote monitoring may be helpful at various aspects in the natural history of patients with cirrhosis, whether it's cirrhosis and surveillance, whether it's preventing alcohol relapse, in identifying the high-risk patient for decompensation, in decreasing readmissions, in improving candidacy for liver transplantation, and also finally managing the high-risk population. Surveillance may be as simple as simple text for reminders, and many studies have shown that this may be effective in selected patients. Apps to detect covert HE. This is an example of the encephalopathy, where this can be used to either detect covert HE, as well as potentially follow patients over time for development. In these two proof of principle figures showing that covert HE changes, and the response time, so the response to the test changes in association with changes with hepatic encephalopathy, a hepatic encephalopathy, both before and after tips, as well as the other way, before and after a correction of hyponatremia. In management of compensated cirrhosis, can we in the future predict patients that may end up doing poorly? In this example, there's the use of remote wireless heart rate variation monitoring, where less variation suggests autonomic system dysfunction and advanced disease. What one can see is that as compared to healthy subjects, stable heart patients have less variation, and those with acute decompensation have even less variation, and in patients with ACLF versus no ACLF, variation was lower. So could one use this to identify a future risk of decompensation? In management of decompensated cirrhosis, and looking at patient reported outcomes, in this study by Dr. Thompson and Dr. Volk, they looked at a script and an automated telephone monitoring system where patients would be called, and they would press different buttons depending on what they felt. For example, have you felt more confused in your thinking compared to last week? Press one or press two. Have you noticed swelling? Press one or press two. And patient reported weakness was associated with time to first hospitalization, and hospitalization rate was associated with patient reported jaundice, weakness, or patient reported five-pound weight change. So again, one more way to engage with our patients. What about Bluetooth-enabled scales? Dr. Bloom and colleagues looked at this in a single center where could integrating this weight changes through an app into the EMR allow for better management. What we saw that there were about three alerts per patient. In about 70% of days, weight was transmitted to the EMR. 84% of alerts were responded by physicians, leading to about 60% with some kind of active intervention, whether this was setting up for a paracentesis or changing a dose of medication. What about providing therapy? Dr. Duarte-Rojo and colleagues have developed the LFIT, which is a series of videos on fitness literacy, as well as exercise training videos, which span the entire spectrum, from education to strength and mobility, to low intensity training, to coordination and balance, could this help our wait-listed patient, where you can not only look at your performance, but sort of compete with other leaders and also receive some validation through steps, through videos, through badges, to show how you are progressing and hopefully improve the fitness on the wait list. Post-transplant, this study by Dr. Xia and Li looked at standard of care as compared to adding an element of telemed-based home management program, which was a combination of vital sign measurement, video education, video communication, and text messages, and again, integrating pulse ox monitoring, blood pressure monitoring, and blood glucose monitoring. And this monitoring, as compared to standard of care, was associated with lower readmissions and higher scores on physical function. The caveats are, is that a significant number of patients required assistance in setting this up. And about after 90 days, only about one out of four responded to any kind of prompts. And with regard to using video, only about 6% used videos. This sort of sets up the final part, which is, can we effectively integrate some of these telemedicine, telemonitoring technologies that have been proposed in the last few years? There remain several barriers to telehealth. Will patients use app? In this study, looking at the use of Encephalab, predictors associated with use of app included patients that had less computer anxiety. And think about our patients. You know, are our patients comfortable with technology? How many of our patients are single? And so caregiver presence was also associated with increased use of app. And in this single center study of the 140 patients that were approached to use the app, 65% said, you know what, we will download it and use it. But at the end of the day, only 10% of the initial population used the app. Overall barriers exist at every single level. At the patient level, access to technology, disease progression, and does the performance change over time? Lack of caregiver support to use this technology. At the provider level, telehealth, telemedicine takes time. What about being reimbursed for many of these efforts? And at the system level, you know, can a system build a reliable infrastructure? Do all systems have the same incentive to integrate if they don't or cannot capture downstream revenue? And could you use this across borders? And many of these things still remain to be seen. As we change the way we provide care in 2020 and 2021 and beyond, where we're dealing more with emergent decompensations, patients dropping out, dealing with the backlog of deferred visits and tests, as well as loss to follow-up, potentially leading to misdiagnoses, incomplete cancer screening, and progressive disease, a reminder that telehealth is only one part of the redesign as we provide care. There are many other aspects that we need to work on. Telemedicine, teleconsultation definitely has potential. An example is HCC management, or as we highlighted, decompensated cirrhosis management with co-management evaluation, treatment of viral hepatitis through teleconsultation, and expanding services, services that we were not historically providing, such as social services or nutrition or mental health services. However, a reminder that telehealth favors systems with infrastructure in place. It favors patients with resources. We need to link intervention to show improvement in relevant outcomes across large sets of populations. And from a public health standpoint, it still remains to be seen if it can help early identification and truly impact care for the underserved. Thank you so much for your time and listening about telemedicine. Hi, my name is Michael Volk, and I'm going to talk to you about value-based payments linked with patient-centered care. This is my bio. I work at Loma Linda, and I'm a health services researcher, focuses on improving healthcare delivery for patients with chronic liver disease. Here are my disclosures. So you may be wondering, what do value-based payments have to do with patient-centeredness? Well, value is simply cost divided by quality. And quality care is patient-centered care because it's not enough for us to recommend all the proper evidence-based treatments. We have to make sure our system is well set up for patients to actually receive them. And when properly structured, value-based payment contracts support wraparound services for patients that are currently difficult to get. So a nurse educator, dietitian, pharmacist, PT, OT, behavioral health. We'll talk about the details of those contracts later. The problems with the current financing system are that the fee-for-service structure limits autonomy and imposes administrative hassles. So the solution to get us back to really focusing on patients is population-less, where we can have a multidisciplinary team or the captain of the ship, and we can focus on delivering all the care that patients need. But the devil is in the details, and we know that capitation doesn't work well because it incentivizes physicians to limit the total amount of care patients receive. So we really need a value-based reimbursement system where physicians are paid for good quality care, not just less care. Cirrhosis is an ideal target for value-based care. It's a well-defined disease. About almost 0.3% of the US population kills 60,000 per year in the US, which is equivalent to diabetes or kidney disease. And the direct costs are over 20 billion per year, which is similar to heart failure. It's also a classic high beta condition, meaning that a small proportion of the patients account for the vast majority of the costs. And so this is important because these patients can be targeted to reduce costs. Now, how well are we doing in terms of quality of care? Just looking at some process metrics, so remember, quality metrics are divided into structure, process, and outcome. This shows the percentage of patients who are receiving prophylaxis against variceal bleeding, HCC screening, secondary prophylaxis against SPP, antibiotics in setting up GI bleeding, antibiotics within six hours of diagnosis of SPP. This is from a variety of different publications. So you can see that we have a ways to go in terms of improving our process metrics. So as I mentioned, the multidisciplinary team, the structure that we envision is that of a cirrhosis medical home. And not that we're gonna become patients' primary care doctors, but that we have a multidisciplinary team with wraparound services to care for every aspect of their liver care. And patients at the center, we have care navigation, we have integration of mental health, and rapid access to urgent care, including paracentesis. In order to deliver that care, we need to be able to know what patients we have with cirrhosis in our clinics, in our hospital, our health systems, and be able to track those patients and monitor their quality measures. So this is why we created the Cirrhosis Quality Collaborative, or CQC. This is a multi-year project, currently involving 10 sites across the country, hopefully eventually more. And this is the structure. Data gets centered at all the various sites, via web forums, including patient-reported outcomes, as well as electronic data transfer from an electronic medical record. The idea being that we want most of the data to come in either directly from the patients or via automated interface with the EMR, because it's not sustainable to pay study coordinators or clinic staff to enter in a bunch of data. So data enters in and goes to a centralized location where that data is converted into usable quality measures and other things, and spits out monthly QI data quality reports, allows us to engage in population management by looking at our cohort of patients and identifying their needs. It sets us up for pre-visit planning, so we maximize that face-to-face time, and then additional outputs in progress, eventually to include costs and other things. Before setting up the software registry infrastructure, we had to create quality measures. And so this is one of the publications from the Practice Metrics Committee, where we engaged in, first of all, literature review, and then created a multidisciplinary expert panel to review and rate quality measures on the basis of the importance, the quality of the data, the reach in terms of the number of patients affected, the gap, so the gap between ideal care and current care, and also feasibility of implementation and measurement. This included creation of patient-reported outcomes, PROs, and we had patients themselves review and rate these measures. So this shows some of the items. You can see that the majority of patients found most importance would be things like fluid in the belly, confusion, itching, and stigma were things that were quite important to them. So once we have identified quality measures, we start collecting them, we have the infrastructure for monitoring, how about interventions? Because it's not gonna do us any good if we collect all this data and there's no good interventions. Well, it's still too early to know for sure, but there's a number of interventions we think we could deliver. So for example, decreasing rehospitalizations, a number of people have done work on this. We know that we can decrease rehospitalizations if we improve the discharge process, give clear instructions to patients on discharge. We educate patients on how to titrate lactulose. We have urgent clinic and paracentesis slots. We get them in the clinic soon after discharge. We keep them out of the hospital by getting them in for paracentesis, et cetera. We know that there's a lot of duplicative testing going on. Patients are seen in different health systems that don't share records, and so there are ways to improve communication between providers so that we don't have duplicates of the same test. We know there's a lot of unnecessary testing going on, and so we can identify and reduce variation by sharing best practices and disseminating choosing wisely topics. I don't know how many of you are aware of this, but if you just Google choosing wisely, you'll find that there's ASLD-supported topics such as not continuing to do surveillance EGDs if a patient's already on non-selective beta blocker, et cetera. And then finally, you recall the slide regarding cirrhosis being a high beta condition, and we can target these high-utilization patients with intensive case management and palliative care, and we're currently working on identifying the best way to do that through the multicenter PCORI-supported palliative care study. So how do we implement value-based care? Well, first, as I mentioned, we have to capture the population, and so we do that via disease registry. Then we measure quality and cost, and we monitor that. Then we set up these interventions to improve value, and we do that one at a time with small changes using PDSA cycles, so Plan, Do, Study, Act. It's a classic quality improvement intervention structure. But then finally, we have to set up a reimbursement structure to pay for all this, and that's what I'll talk about next. So how do we do that? Well, first of all, we have to clearly define what the structure would look like. We have to establish inclusion and exclusion criteria, so which patients are going to be included and which patients are going to be excluded. We have to define entry and exit triggers, so when do patients enter the reimbursement structure, and when do they exit? So for example, you might have a reimbursement structure that's only focused on decompensated cirrhosis, and so patients enter when they become decompensated. They may exit when they get a liver transplant or perhaps when they go on the transplant list, or if they die, if they go into hospice. And then there has to be a financial model. And so here are potential options for financial models based on varying levels of risk. So the simplest and kind of the first step for many people would be level zero. So this is essentially a fee-for-service with a per-member, per-month overlay. So in other words, you convince an insurance company to do a pilot, and they agree to pay per-member, per-month fee for all these services and pilot test for a year, and see if this program is able to reduce their costs. Then next step would be fee-for-service with upside risk only, so this is shared savings. Instead of a fixed per-member, per-month, the hospital health system or practice shares the upside risk. Upside risk is that the provider shares in the cost savings of the insurer. So in other words, if we're able to reduce costs for these patients, this population, then we get a part of those savings. If we don't reduce costs, then we don't get any savings. So you can see that level one is a little bit riskier because you could end up not getting any payment for all these services, if you hire a nurse manager, an extra dietician, et cetera. Level two is even more risk, so this has upside and downside risk. So if we save money, we share in some of the savings. If the costs end up being higher than before, than whatever the agreed-upon baseline is, then we actually not only don't get paid for the extra services we're providing, but we actually have to pay the insurance company. And then level three would be population-based payment or global budget. So this is essentially capitation with adjustments based on value. So in other words, if one saves a ton of money, one makes a ton of money, but those payments are deducted based on value. So if one does not deliver quality care, then one makes less money. So these are the various levels of risks that one can set up with one's local insurance company. So here are some examples. So we have a permanent clinic in Las Vegas, and we're the major transplant program for Southern Nevada. And we work very closely with the Health Plan of Nevada, which is a large HMO. And what they have done is essentially a variant of level zero, which is we have a fee-for-service contract with them, but instead of actually giving us money, they have given us resources. So they have embedded a case manager in our clinic. They've provided 24-7 behavioral hotline because they believe, and hopefully this will pan out to be true, that we can help save them money by keeping their patients out of the hospital. Case example number two. I've been in a series of meetings with Inland Empire Health Plan, which is a large managed Medicaid plan in Southern California. So we don't yet have a final agreement with them, but my pitch to them is that if we assume that their population is 700,000 large and 0.27% of the adults have cirrhosis, that's about 2,000 members with cirrhosis. And we know that on average, cirrhosis members cost them about 20,000 per year. That's based on their own data. And so that means 40 million per year in spending. So if we're able to realize a 10% reduction in spending, we can save them 4 million per year. So my pitch to them is give us 500,000 of this per year and we'll save you 3.5 million. So we'll see. We're still in discussion. Now, final example is currently implemented at many centers across the country. Many of you don't realize, but liver transplantation is reimbursed in a bundled way. So most of the care, sometimes pre, but usually a lot of the post-care is bundled and in-hospital care. And so there has to be an internal structure to funnel that money, and there usually is, to support the transplant optologist, for example. But it's not just financial. It's also quality adjusted because insurance contracts are dependent on, in many cases, getting Certificate of Excellence status or Center of Excellence. And those are based on quality measures on outcomes, the CRTR outcomes, things like that. And the structure pays for the wraparound services. So many of you in your transplant programs have social workers, have dieticians. They don't bill. So those wraparound services are covered by this bundled reimbursement. So this is essentially value-based care. So moving forward, next steps. Nationally, we're continuing to expand the CQC, validate the QI measures, start collecting cost data. We are planning an ASLB industry colloquium, and probably now push to 2022 because of COVID. And I would encourage many of you to partner with your local insurance company and start having discussions with them, build a relationship, and then this could eventually lead to some type of value-based contract with them. And feel free to contact me if you have any questions on how to do that. Thanks very much and look forward to your questions.

patient-centered care

chronic liver diseases

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patient-centered outcomes

value-based payments

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