Hello, good afternoon. This is Dr. Piers Mofrad. Thank you for joining our conversation presentation today. We'll be talking about the CMS mandated shared decision-making. I'm Dr. Piers Mofrad. I'm the director of cardiac electrophysiology at Adventist White Oak Medical Center and the vice president of cardiology at the same institution, but thank you for joining us today. I look forward to the little talk today about shared decision-making. Hello there. In our discussion today, our objectives are going to include defining what the CMS mandate regarding shared decision-making includes and define some of the essential elements of shared decision-making. And then we can go through some of the procedures that are actually recommended or required to have shared decision-making performed. Some of these for reimbursement purposes as well. And we'll talk about how that can be done, explore techniques, talk about future directions, and ways to facilitate that for patients in this very important topic. Just to discuss a little quick definition of national cover determination, these decisions are made through a kind of evidence-based process. So when new procedures come about, even old ones, at some point coverage had to be defined by CMS. And this is performed via national cover determination where they use an evidence-based process. They go through, they look at the coverage of these items, these services, and see what is medically necessary either for treatment or diagnosis of an illness. This process covers, again, older procedures and is available for new technologies. And some services, as you know, are new. So therefore, local coverage can be provided by your local Medicare contractors until a national cover determination has been performed. Typically, it's performed within six months of application and does allow for public input to the decision. Now, what's important about this is that national coverage determination in the last several years has really incorporated and mandated that shared decision-making be performed for certain procedures as a prerequisite for reimbursement. That's both for physicians and for hospitals. And some of these key procedures involve, obviously, in the electrophysiology procedures and in-realm. And we'll be speaking a little bit more about that as well in a moment. So what is shared decision-making? Well, shared decision-making was born out of a concern by CMS to have a more equitable way of discussion of the risk and benefits and the long-term goals for the patients during procedures. It's a concern they had that patient autonomy be recognized and kind of have a two-way street where both physicians and patients can engage with each other with the use of different decision aids and discussions in the office and the hospital to help make a better decision for the patient's long-term procedure based on the outcomes and their history and their wishes. Shared decision-making was proposed for several arrhythmia situations or treatments and it's been mandated for certain procedures, again, as a condition for reimbursement. It goes above and beyond what you typically consider the informed consent process where patients just get this quick discussion about the physician, whether it be in the office or in the hospital, with then the applicable signatures being performed. It's envisioned to be more of an equitable exchange of free discussion of information so these treatment options can be better tailored towards the patients and they can make a better educated decision as far as what they want to go forward with. And again, the principle driving thought for this is patient autonomy. That's one of the big big pushes for this shared decision-making. So again, there are several procedures we'll go into about that have been recommended, mandated, that is, that shared decision-making be performed in addition for their reimbursement requirements. So as far as with shared decision-making, how can we measure their benefit, their efficacy, essentially their outcome? There are different ways we can do that. There have been patient reported surveys that have been developed. These include also provider reports that providers can then also fill out to see and measure their reported outcomes with shared decision-making, as well as observers who can be present during discussion with patients. They're also able to provide some outcome measurements. So for patients, there has been a set of surveys that have been developed. Those include the SDM Q9 as a set of nine questions that patients kind of self-report their impression of their involvement in the shared decision-making process, how they felt their outcomes can be influenced as well throughout the process. The provider-reported versions of the same SDM Q9 can be applied in research programs as well, and it's very similar to the patient-reported surveys. And the same thing for outcome measurements based by observers. They're typically present at the time of the decision-making encounter, and they can provide their input and their impression on how the outcome has been met and how the shared decision-making process has been performed. Now as far as looking at the outcome trials that have been developed and have been performed, that is for shared decision-making, a lot of these really take a look at the decision aids that have been developed for shared decision-making and try to come to some outcome measurements of how the decision-making process, whether those decision ailments and decision aids were easy to use, were they likable by the patients, are they easy to find, did they go through the treatment intent, and discuss the health care outcomes as well. So there's a lot of vital information. So what are these decision aids that we keep on alluding to? Well, these decision aids are used as a component that are designed to improve the quality communication between the provider and the patient on the health care system. They go above and beyond what you typically consider, again, informed consent, and they provide a lot of informational materials that can be given to the patient regarding their treatment decisions and options. And it also helps to, again, provide that patient autonomy we've been speaking of alluding to, helping to kind of clarify the patient's values and goals in this whole process, and providing a two-way street where patients and physicians can really meet together to go through their options, and provide an honest value-based and risk-to-benefit-based discussion. So it provides a lot of baseline information to promote clinical discussion of the treatment options for patients, that is decision aids. So as far as decision aids, what they can include, there are clearly defined decision aids that are like traditional handouts that you can print off the internet. You can print them out for your institutions. They can have some of these available. Some of these are actually incorporated in the electronic medical records system as well. Others can be websites that you can refer patients to after discussion in the office, allow them to have more time off out of the office discussion to get a better grasp of their treatment options. And also apps included as a decision aid have been developed as well. So again, these decision aids, as we call it, can be used at a time of either the outpatient or inpatient discussion, an initial encounter or follow-ups, or sequent encounters with the patients prior to the official decision-making process that the patient then undergoes, or has to undergo, that is. There is a national quality forum that did get certified, began in 2016, that tried to serve as a certifier of shared decision-making tools and process. However, their outcome and their input has been somewhat limited, unfortunately, since that time. But there is a formal mechanism by this nonpartisan organization that is available. What you see here are some decision aids that I just printed out and put together on a slide. There are ICD implants, defibrillator implants. These are handouts that can be easily given to the patient at time of discussion. They can take home with them as well. Again, some images here of the shared decision-making tools for left atrial appendage occlusion devices. There are handouts from the ACC, web-based handouts that have been designed to help patients during this process of their decision-making, as well in this electrophysiology procedure. Decision- making aids as well have been developed for anticoagulation atrial fibrillation to help patients go through their decision-making process as far as whether they want to initiate anticoagulation. If so, what agents they think are best for them and the benefits and risks that are associated with them. And it is quite valuable, again, as our population is aging, there's a lot of risk-to-benefit ratio that must be discussed at the time of initiation of these medications, especially some that are irreversible, some that may have increased bleeding risk with people with age and comorbidities, including diabetes and renal disease. So, one of the electrophysiology procedures that we do perform are defibrillator implants. Now, back in 2017, the ACC and American Heart Association, in conjunction with Heart Rhythm Society, actually listed shared decision-making as a class one recommendation in their guidelines for sudden cardiac death. And since that time, CMS has actually mandated this use of decision aids for patients considering ICD implants to their reimbursement. That is, these shared decision-making aids must be used and must be documented in order to allow for CMS to reimburse physicians and hospitals for defibrillator implants. Now, again, defibrillator implants are meant for patients, either for primary or secondary prevention of sudden cardiac arrest in selected populations, typically people with dysfunction, heart failure, or those people who actually survived the sudden cardiac arrest. And again, these shared decision-making tools that have been developed really try to incorporate and highlight the risks and benefits for patients, not just during the procedure, but long-term. There's a lot of downstream topics of discussion, including future lead fractures, infections, time of generator changes, concern for lead revisions, and even discussions, again, of end-of-life deactivations and device recalls, lead recalls. So there's a lot of discussion that needs to be entailed prior to implant of these devices. Cardiac resynchronization therapy is a component of either defibrillators or pacemakers. Those are devices that are meant to be able to pace the heart for patients who have heart failure, symptomatic heart failure, who have some conduction system disease. So it's been shown to improve the outcomes, both on the heart failure class and even improve the heart function of selected patients. So CRT, as we call it, is a complex decision-making process. And again, given it can involve pacemakers or defibrillators, shared decision-making is clearly recommended for those patients who can be eligible for these implants. And again, it's another complex discussion that can be formed in the office with the help of these decision aids. As well, in pacemaker therapy, the 2018 American College of Cardiology, American Heart Association, and Heart Rhythm Society guidelines at that point also recommended shared decision-making be evolved in the process of discussion of risk and benefits of pacemaker therapy for patients with symptomatic bradycardia. Now, shared decision-making can become quite important for those patients, especially with advancing age, frailty, comorbidities, issues with access, end-stage renal, recurring infections. And as technology improves and evolves, new procedures such as TAVRs have increased risk of pacemaker implantation, and discussions definitely need to be performed at the time or prior to implant. And with newer technology, those discussions also include discussion of options, not just lead pacemakers or leads, but also leadless pacemakers that have been developed for patients who are not great candidates for lead pacers due to either vascular issues or recurring infections. In 2014, the American College of Cardiology and Heart Rhythm Society again also recommended that shared decision-making be performed in discussion of anticoagulation therapy, so having a more individualized discussion with patients, because no two patients are the same. Every patient has a different set of risk factors for bleeding, different set of risk factors for thrombosis and stroke in the setting of atrial fibrillation. So this kind of two-way street discussion, where it's individualized care, a discussion of the risks of blood thinners and the benefits, was recommended to be performed for patients with atrial fibrillation at the time of discussion of anticoagulation. And more importantly, as we see a lot of patients, at least about 50% of patients who are prescribed anticoagulants, no longer take them at the one-year mark. And that is important to try to improve upon, and the hope is that with shared decision-making discussion, that patients feel more involved in their care, have a better understanding of why they need to be on anticoagulation, and the risk and benefits of discontinuation or missing doses, not taking their doses. So by hoping to get patients more engaged, improving that communication and discussion, hoping that the penetrance of anticoagulation, a long-term adherence, can be improved over time. So as far as lepidatrial occlusion devices, those are devices that can be implanted in the heart for patients, in the left atrium that is, in the appendage, for patients who are not good candidates for long-term blood thinners. There can be various reasons for that. Patients who have prior bleeding, patients with poor adherence, patients who just can't tolerate, due to side effects, different multiple anticoagulation regimens. This has been a treatment option that's been developed, and CMS actually mandates that shared decision-making be documented, just like they mandate it be documented in a setting of defibrillator implants, as part of its coverage decision for these procedures. So not only is it vital for hospitals and physicians to incorporate that in their preoperative assessment and documentation, but also it's vital, given the complexity of the procedure, to have these discussions with patients prior to the implant, so they have better understanding of not only the risk and benefits, but the downstream side effects or implications of these implants down the road. As far as in the setting of arrhythmias and ablation, shared decision-making has been noted to be included in 2019 ACC AHA consensus statement on ventricular arrhythmias, where it's mentioned that shared decision-making skills be developed and recommended in order to effectively communicate and counsel patients on the risk and benefits of catheter ablation. These discussions are recommended to take place, obviously, at the time of the outpatient or inpatient consultation. It can incorporate, again, patients' long-term wishes, their overall health goals, their values, their overall risks based on their past medical history, and a clear-cut understanding of the long-term efficacy of these procedures for patients. It's quite vital, given that patients have different substrates and different comorbidities that may make them higher risk for certain procedures and perhaps even a lower efficacy of these procedures as well. So, multidisciplinary teams have typically been involved in many of the complex cardiac procedures and care at hospitals, including those for structural heart disease, left atrial appendage closures, and device therapy. A lot of times, physicians have been, in the past, heavily relied upon as a primary vector of discussion for patients in the setting of these implants or these procedures, and, of course, in the shared decision-making process. But as the diversity of caregivers in the outpatient and inpatient setting continue to evolve, it's the hope that these multidisciplinary teams can help educate and facilitate further discussion with shared decision-making with other components of the healthcare team. That would include nurses, nurse practitioners, physician assistants, and extenders to make this a more ubiquitous process and an easier process to perform. As far as shared decision-making and its role in reimbursement, I alluded to this earlier, that shared decision-making clearly has been mandated as a coverage determination and a requirement for reimbursement in certain procedures. And those procedures, again, include that shared decision-making and its aid be documented and demonstrated in the discussion and process for left atrial occlusion devices. And that's been developed since 2016, been mandated since 2016 by CMS, and since 2018 by CMS for a prerequisite for reimbursement of defibrillator implants. So this is nothing new. This has been there for a while and is definitely not going anywhere. The hope is that in the future, in order to make shared decision-making more ubiquitous and easier to institute, there are institutions and healthcare systems that have championed what you call site-specific champions, that is, whether it be a physician group, physician extenders, they help implement shared decision-making within those institutions. They help develop the decision aids and incorporate them into the EMR systems to help benefit a more systematic approach and system-wide approach so that shared decision-making documentation and implementation is performed in an easier fashion and more complete fashion. And again, as I had said, consideration of incorporation into electronic EMR systems has been performed and is performed at various institutions. Education of physicians and physician extenders as a team approach is vital as well. And in the future, there are decision aids that have been developed for family members as well. There are certain patients that have decision surrogates, and it's important that these family members that are involved in those situations where patients are either cognitive or physical impairment does not allow them to be fully consensual, that we have these decision aids developed for them as well. As far as future direction to help facilitate implementation of shared decision-making, there is a hope that CMS will consider reimbursement of the time spent by either physician or physician extenders and the process of shared decision-making as a component of reimbursement. So that may help to further the adoption process of shared decision-making and the compliance that is. And now adoption also can be improved and will be improved by societies further reinforcing their recommendation for adoption and their future guidelines. And we see this occurring every day. And they can help discuss concrete pathways for implementation of shared decision-making. And again, these discussion includes cultural, religious, and socioeconomic status that can impact the adoption of shared decision-making at different institutions. And there are future studies that are ongoing and being proposed to help determine if this shared decision-making process improves patient outcomes and adherence as a therapy. And we are looking forward to getting more of that information in the future to help further facilitate implementation of the shared decision- making process. So at our institution, Adventist White Oak Medical Center, we have implemented a team approach to our structural heart disease program that includes left atrial occlusion devices and TAVRs and ICD implants. And we have a team of physicians, physician extenders, nurse practitioners, registry team members that help us to ensure that every patient has been exposed to and has had that discussion regarding shared decision-making that has been implemented and documented well within records prior to their procedure, whether that be as an inpatient or an outpatient. These aids are easily available in our institutions. There are sites within the cath lab and electrophysiology lab where we make available our site-specific decision aids. And some of these aids have been incorporated into our electronic medical records system as well, including we use the Colorado form as a decision aid in our patients for defibrillator implants. So we make it as easy as possible to provide that information to patients to allow that discussion for physicians, physician extenders to occur. So in summary, decision-making, shared decision-making that is, is definitely here to stay. We expect more societies to implement guidelines, more concrete guidelines on how to implement that and develop more decision aids to help patients across the cardiovascular spectrum of procedures. Further trials are expected also to perform again, be performed again to look at the objective outcomes and look at the cost-effective nature of shared decision-making and how it impacts patient outcomes. And as these continue to evolve and decision aids become more prevalent and societies take a more active role, we also expect CMS to also likely provide further mandates for shared decision-making as a requirement for reimbursement, other procedures as well. I wanted to provide some of the list of some of the decision aids that we use in the electrophysiology realm for not just defibrillator implants, but also for Watchman or the left atrial occlusion devices. Some decision aids for anticoagulation, stroke prevention and defibrillator implants are listed here for your benefit. Please by all means take a look. It may benefit your institutions as well. It's been a pleasure speaking with you today and thank you for your time. Have a great afternoon.

shared decision-making

healthcare

patient autonomy

medical procedures

reimbursement

decision aids