Expanded CMS Coverage and Guidelines: Interview with Bruce L. Wilkoff, MD

First of all, explain the new ICD coverage provided by CMS. On January 27, CMS reaffirmed the coverage for secondary prevention for people who have had a cardiac arrest and for people who have had a previous sustained tachycardia either inducible in an EP study or spontaneous. These are the secondary prevention indications and these patients do not need to go into a registry; however, all other patients need to go into a registry for primary prevention. Primary prevention is when the patient has not had a previous spontaneous arrhythmia. In a lot of the patients, there is overlap to what was covered before, but there is also a lot of simplification now. On the ischemic side, where there was previous coverage, now the rule says if you have an ejection fraction of 35% or less, are at least 40 days out from a myocardial infarction, and are at least three months out from revascularization, you can get a defibrillator. It is slightly more complicated. If your ejection fraction is less than 30, you don t have to have any heart failure symptoms; however, if your ejection fraction is between 31 and 35, then you have to have some limitation in activities from heart failure described as functional class 2 or 3. The major thing that happened was that we got coverage for non-ischemic cardiomyopathy. Therefore, for these patients who do not have coronary disease, have never had a myocardial infarction, but have functional class 2 or 3 heart failure and their ejection fraction is less than 35%, they can receive coverage for a defibrillator. This is completely new. There was also another group that was previously covered for people with inherited and/or familial causes of ventricular fibrillation. They were covered before and although there is information that needs to be entered into the registry, there is not new coverage. These guidelines have made it much simpler, from the standpoint of talking to patients, in terms of talking to other doctors, in terms of triaging your thought process. You still have to know people s ejection fraction, what their heart failure class is, and how long it has been going on. What they didn t prescribe although it is the right thing to do was that these patients should also be on medications such as ACE inhibitors and beta blockers, for example. The one other thing that happened with the non-ischemics is that there are two timeframes that were prescribed for duration: one was three months, and the other was for nine months. It is clear that they want to cover all patients from nine months out from the diagnosis of heart failure, but ultimately the decision the way it is written will be that all patients three months out from their diagnosis will be covered. The difference is that in the short run we are setting up a temporary registry, and while it is in place you ll have to wait nine months in order for an implant. However, hopefully within a year there will be a more permanent registry, and at that time it will drop back to three months. There are exceptions, though. For example, you can receive one if you are in a FDA clinical trial, which is an exemption, so at this point you can still do it in three months, but you have to be one of the small subset of patients enrolled in a clinical trial. The other thing is that in three separate times in their statement, CMS talked about the qualifications of people that are putting in devices, and they strongly suggested that these physicians be qualified. They strongly encouraged the credentialing of these physicians. They didn t require credentialing in order to pay for it, but in the short-term registry and I m sure it will also be in the long-term registry it will matter whether someone is credentialed or not. Therefore, there is a strong message coming from CMS. At this year s American College of Cardiology (ACC) meeting, I listened to a presentation by Steve E. Phurrough, who is one of the main people from CMS, and they were really strongly urging the society to provide ways to make sure people are credentialed adequately. What are the current training guidelines for device implantation and therapy? How do you think being "formally certified" will affect those interested in device training? Two things. It is clear that if you are certified by the American Board of Internal Medicine after going through a standard cardiology fellowship, then through an electrophysiology fellowship, and then pass the certifying examination that this would be adequate enough in terms of credentials. However, it turns out that not everyone that does that performs defibrillator implants or is even skilled in that. On the other hand, there are quite a number of people who have implanted pacemakers in the past and/or who have been putting in defibrillators for quite some time some of which are skilled and some of which don t know what they are doing. Therefore, the Heart Rhythm Society has put together a document on clinical training for alternate pathways. This was reviewed and approved by the board of trustees of both the Heart Rhythm Society and the American College of Cardiology. That document suggested that: 1) you are an experienced implanter; 2) you are proctored in putting in 10 defibrillators, five ICD revisions, and five CRT implantations; 3) you also went through a training process; and 4) you took a significant examination (and the only significant examination of this type is the NASPExAM, which is the special examination in competency examination in cardiac pacing and defibrillation). The NASPExAM examination does test device knowledge, although not necessarily device implantation skills, but it does test the cognitive part of what goes on and is a pretty good indication of your skills. So all of those forms of evidence for credentials would meet the criteria that CMS has been talking about. CMS has been working quite closely with the Heart Rhythm Society to make sure there is opportunity for that kind of credentialing to go into place. Do you think there will be a need for more qualified practitioners to meet the expected demand for more device implants? It always works that way if there is more demand, more people will be interested in doing it. Some of them will do the traditional electrophysiology training program, and some of them will do it in an alternative pathway. Clearly, if there is a demand, there will be people that will move toward that, and the question is how quickly will that happen. It is going to depend on the motivation and how things develop. I also expect that there will be some profit motive in all of this too. People will see a billable procedure, so it will become more interesting for them to learn how to do it. There has been talk about developing a subspecialty of cardiology that would cover the management of devices. Are you in support of such a program? Who do you think should be putting in implantable devices? Well, you know that is very controversial. I think the reason that the document about alternative pathways went into place was because there are probably about 4,000 physicians half surgeons, half cardiologists, approximately who are actually doing it but who are not necessarily skilled in doing so. Nor is there any evidence as to who are the better implanters and who are not good implanters. My personal feeling is that anybody who has the skills to do it right should do it. On the other hand, people who are not trained to do it should not be doing it. I do see the possibility that there will come a day when a clinical cardiologist will have a lot of these patients in his practice because a lot of patients are going to be indicated for defibrillators. A good cardiology fellowship might someday include a pacemaker/defibrillator implantation. I mean, for all I know we may see the changing of training requirements for being a general cardiologist. At this point in time, it is going to take awhile to get there, because there is turf involved here and it is just not going to happen overnight. Each of the societies has a hard time seeing beyond their own constituency to the general need. Therefore, it s not going to happen easily, either. Certainly the manufacturers want to see more implanters, because the more implanters, the easier the access. However, I think it is the responsibility of the physician community to make sure that we maintain quality at the same time. I personally believe that there is plenty of room and plenty of devices to be implanted, and that we instead need to increase our vision of how to train our physicians. However, there is no clear pathway on how that is going to happen and certainly there is no society who is picking it up. The Heart Rhythm Society has tried to be realistic about this, acknowledging that people were already going out and doing the implants, and so they came out with their alternative pathways document. The reason for that is to recognize that the cow is out of the barn already people are doing implanting the problem is that some of the people who are doing it are doing it badly, and that is not helping anybody. We have to stand for quality, because you can get in trouble with these devices as well. What do you think would be the best long-term outcome? I think you just need to have qualified people that know how to do the implants. The long-term history is almost kind of funny, in that pacemakers were originally implanted by surgeons. Then surgeons became uninterested in pacemakers because they were doing bypass surgery, and so they sort of abrogated the whole field to cardiologists. Then, for a long time, cardiologists were uninterested because they were taking care of coronary disease and all sorts of other cases. Only when defibrillators became transvenous and started getting this outcome have people started to pick up their ears and think about it. Of course the surgeons, who are losing all sorts of procedures because people are doing more angioplasties and stents are getting back into it, and the general cardiologists are doing so as well. There is a lot of self-interest and political maneuvering that is going on here. I think what the Heart Rhythm Society has to do is go for qualified people doing implants; that doesn t mean that they have to be trained to do ablation or other techniques in electrophysiology (which electrophysiologists can do just as well). I think there is going to be a conglomeration in 5-10 years, you are going to see a large segment of general cardiologists that will be experts in several things: echo, imaging with CT scanning, heart failure therapy, and implantable devices. I think you are going to see general cardiologists doing this in the long run, and they are going to be a new breed of cardiologists they are going to have had specific training and are going to be specially trained. Also, in the long term, I think the government is going to require it. However, it s not going to happen overnight it is going to take years. Is there anything else you'd like to add? The only other important thing to mention here is the overlap with biventricular pacing is enormous. There was another big study that came out this last week the CARE-HF study to which there was a long-term follow-up of patients who had biventricular pacing or just medical therapy. It showed that biventricular pacing by itself had a 36% reduction in total mortality without a defibrillator, just by biventricular pacing. Therefore, with the overlap of biventricular pacing and defibrillation, I think the interest of being an implanter is just going to skyrocket, and because of that, we are going to have to wrap up the training requirements in this area. Some of that is going to happen from EP, but I am just as certain that some of it is going to come from other segments in the cardiology community. The information on this trial was presented simultaneously at the American College of Cardiology meeting and also was published in the New England Journal of Medicine.