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Ann Thorac Surg 2001;71:S202-S203
© 2001 The Society of Thoracic Surgeons
Presented at the Fifth International Conference on Circulatory Support Devices for Severe Cardiac Failure, New York, NY, Sept 15–17, 2000.
DR WILLIAM L. HOLMAN (Birmingham, AL):
One thing that Dr Moskowitz mentioned during his talk was the concept of a quality-adjusted life year, which I think is a potentially powerful way of expressing to people in the business world and government the merit and value of mechanical circulatory support. A good example is in the Institute of Medicine report in which the investigators examined percutaneous transluminal coronary angioplasty (PTCA) and the cost of inappropriately used PTCA. In fact, the cost of an inappropriate angioplasty in a patient with single-vessel disease that is otherwise medically manageable, rivals the course of an appropriately used left ventricular assist device (LVAD). If you think about the economics, however, an inappropriately used LVAD is leveraged out of sight in terms of the cost per quality-adjusted life year, which makes the appropriate use and dispersal of the technology really crucial.
In the United States we have a "crazy quilt" of state-based certificate of need to determine which hospitals will use or be able to have the technology. In Europe, Dr Beyersdorf, how do they decide, or at least in your country, which hospitals are going to be able to implant LVADs?
DR FRIEDHELM BEYERSDORF (Freiburg, Germany):
Just a few months ago there was a joint effort from the Social Ministry and the insurance companies, and they actually decided on which medical centers would be allowed to use the technology. The driving force behind this decision was that there were, too many transplant centers, and some of them were doing only one or two or three transplants, which is completely ridiculous.
DR MICHAEL A. ACKER (Philadelphia, PA):
Two questions. I guess we are going to have several new Food and Drug Administration (FDA) studies in this second generation of VADs, whether it is LionHeart or the new axial flow pumps. The first question is directed to Ms Dolak. What are the chances of this new directive to the Health Care Financing Administration (HCFA) actually resulting in them, paying for these new clinical studies, for which several companies have submitted investigational device exemptions? Are they going to pay for these studies or not? Will it be that each company will have to negotiate with HCFA separately, or can we assume that this reimbursement policy will actually be followed for VADs, unlike drug studies?
MS JEANNE FITZGERALD DOLAK (New York, NY):
HCFA has established a New Technology Committee to review these kinds of requests. I cannot imagine that they would address multiple requests on the same type of device. So probably, it is much more likely to happen as a unit than separately.
DR ACKER:
From that answer, the next part of the question is to Dr Portner. Given the likelihood that HCFA will not pay a substantial portion of the routine costs for this new technology in FDA I and II, what do you feel is the company’s responsibility of paying more than just the VAD? Let us say it is $100,000 for the implant and $100,000 in hospital costs, not counting physician fees. In the past, VAD companies have not come to the plate to pick up the implant costs, let alone anything more. Do you think that will fly in this environment? Are these studies going to fly in most institutions without increased support per patient by the companies themselves to decrease the risk to the hospital?
DR PEER M. PORTNER (Stanford, CA):
That is not an easy question to answer. The issue is basically economic. Traditionally, in clinical trials, companies have provided devices or drugs without charge. And the point I was trying to make earlier is that mature products such as grafts, valves, and pacemakers are between two and three orders of magnitude less costly than this very expensive technology. Typically, such products have costs 10% or 15% of the price, and so giving them away is not nearly as big an issue as it is with these circulatory support technologies. Obviously, to carry out trials, you have to use all the mechanisms you can. And that includes providing the product at no charge. As I said earlier, the economics for this industry are not that healthy today. Until there are significant revenues or a base from which to pay for these expenses, it is just not a realistic option. So the only alternative is government funding.
DR ACKER:
Right. The problem is that now, unlike 10 years ago, the economics of hospital reimbursement are much poorer, and there are many health systems that will not take on that risk, based on the prestige of having this trial. The problem is the economics of the companies and the hospitals, both of which are going to have problems taking on $100,000 unreimbursed cost without some help. Obviously, we had hoped the funding would come from HCFA, but that may not be forthcoming.
DR HOLMAN:
There is an update available on the Medicare web site.
MR ED BERGER (Woburn, MA):
I just want to clarify the status of the HCFA initiative. HCFA did publish a notice, essentially a notice of intent to establish a new national coverage policy for clinical trials, and accepted public comments until September 5, 2000. If you read the notice, which is on the HCFA Web site, HCFA’s intent—and it seems fairly clear that they will implement this—is to pay all of the costs of the trial except for the cost of the experimental device and protocol-induced costs. We’ve got explicit confirmation that that means they will pay for the cost of the operation for the implantation, and all preoperative and all postoperative care.
What we do not know at this point is how they are going to manage that and what the actual cost will be. But clearly their intention is to take care of the concern that was just expressed, and we ought to know more details by the middle of October.
DR ERIC A. ROSE (New York, NY):
Maybe I could comment on the HCFA issue, too. I have been there enough times to try to get them to pay for a bona fide clinical trial that I think I have some insight into HCFA thinking.
There are a lot of serious reimbursement issues that I think they legitimately have. First and foremost is how do you define a clinical trial. Their point to me, when I first went to talk to them about REMATCH, was if a company comes in and says it wants to do a clinical trial of a new wheelchair, and the company calls it a clinical trial, if we’re going to reimburse you, why shouldn’t we reimburse for that clinical trial as well?
It might seem at first glance that it’s easy to differentiate trial devices. But you start looking at orthopedic devices, new casts, new nails, just about anything, new forms of dialysis, you realize that there is an enormous Pandora’s box that this could still open up.
I think that is exactly what they are grappling with now, looking to clarify the language. I think this industry is relatively primitive in its ability to unite and present a unified case. If there are a group of IDEs in place at this point, I do not know if the manufacturers are working together or either through some new organization or through the Health Industry Manufacturers Association (HIMA) (now called AdvaMet). But there are lobbying opportunities for people to put together coherent language essentially to work with the agency to figure out specific ways to target resources toward a very legitimate need. It is not easy to do, but the level of receptiveness now on the part of the agency, I believe is as high as it has ever been.
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