WEST VIRGINIA HEALTH CARE AUTHORITY
RADIATION THERAPY SERVICES
CON STANDARDS MEETING
11/5/2008 – 1:00 pm EST
Conference ID # 137202
Ms. Sonia Chambers: I want to welcome everybody to today’s meeting. My name is Sonia Chambers. I’m Chair of the West Virginia Health Care Authority. We have the entirety of the Board here today, Sam Kapourales and Marilyn White. For those of you who do not know, the legislature has been examining whether to continue or make changes to, or keep as is, the Certificate of Need law in West Virginia and has asked the Authority to conduct a series of meetings allowing people to have input into whether various services, each of the services, ought to remain reviewable or not. We have conducted five or six of these meetings to date and today’s meeting is on radiation therapy services. What I would like to do is to have Dayle Stepp briefly outline that standards…well, actually first we’ll go around the room here in Charleston and tell you who’s here, find out who’s on the phone, we’ll have Dayle outline the standards, and then we will open up the floor for comments and discussion. We are recording these meetings and there will be a transcript, so if you’re going to make a comment, please identify yourself so that your comments can accurately be reflected in the record. Also we would welcome anyone to submit written comments to use after today’s meeting. We would ask that you do that 30 days from today and then we will forward all of the comments from today’s meeting and any written comments to the legislative staff and leadership and members of the select committee looking at the issue. So with that, why don’t we start with those who are on the phone, please identify yourself.
Mr. David Jarrett: This is David Jarrett from CAMC.
Ms. Pat Woods: This is Pat Woods and Stacy Hanshaw from the Bureau for Medical Services.
Ms. Jill McDaniel: This is Jill McDaniel with the Hospital Association.
Ms. Sonia Chambers: Anybody else on the phone? Anybody else who might have had the phone muted and is having trouble finding the mute button? It happens to me sometimes. All right, as I mentioned we have Marilyn White, Sonia Chambers, and Sam Kapourales.
Mr. Dayle Stepp: Dayle Stepp, CON.
Mr. Tim Adkins: Tim Adkins, CON.
Ms. Sheila Kelly: Sheila Kelly, CON.
Mr. Ed Hamilton: Ed Hamilton, Mountain State Blue Cross Blue Shield.
Mr. Bill Wright: Bill Wright with Radiology, Incorporated in Huntington.
Mr. Gary Murdoch: Mr. Gary Murdoch, WVU Hospitals.
Mr. Bob O’Neil: Bob O’Neil with Dinsmore & Shohl.
Dr. Lewis Whaley: Lew Whaley with Charleston Radiation.
Ms. Kay Myers: Kay Myers, Health Care Authority
Ms. Raymona Kinneberg: Raymona Kinneberg representing Logan Regional Medical Center.
Ms. Amy Tolliver: Amy Tolliver, West Virginia State Medical Associates.
Ms. Martha Morris: Martha Morris with the Consumer Advocate’s Office and Insurance Commission.
Ms. Cindy Dellinger: Cindy Dellinger, the West Virginia Health Care Authority.
Ms. Marianne Kapinos: Marianne Kapinos, General Counsel, Health Care Authority.
Ms. Sonia Chambers: Okay, anybody else that’s on the phone? All right, Dayle.
Mr. Dayle Stepp: Okay, on the standards I’m just going to jump to the need methodology. It says a new facility was half served with population of 350 patients using the methodology in the standards. The service area is the 2510 service area for acute care services. The need methodology is the projected population for the third year of the project using the number of new cancer cases for the last five years from the West Virginia Cancer Registry, calculated accrued rate for the incidents of cancer, apply to the service area of population to get the estimated number of cancer patients, calculate 60% of that number for the people who would be expected to use radiation therapy, subtract the number of patients being treated within the service area if it’s more than 350, and it shows the need for an additional unit. The Authority may consider an application for a new facility if the applicant can demonstrate, using this methodology, that the unit would create a population of 200 patients, not within 60 minutes, normal driving time, of an existing provider. If they want to replace it, they have to show that it is doing at least 6,000 treatments per year or because of age or maintenance costs or wear, it can’t be used. They can request that an existing unit be declared obsolete and used as a backup, but it can only be used when the main unit is down. If an applicant wants to develop a comprehensive cancer center, they can present alternative need methodologies and there’s a list of services that they have to be able to provide and a quality, they have to have a certified radiation physicist available for calibration, they have to have an on-site licensed physician who is Board certified and who must be on site when all the services are provided, they have to have qualified, trained staff, a radiation therapist, physicist, treatment planning staff and such. These people must also be on site when services are being provided. They have to have a quality assurance program, policies and procedures for equipment malfunction that’s provided directly through contractual arrangements, diagnostic services, consultative services, social services, rehabilitative and supportive services, treatment services, and they have to be affiliated with the West Virginia Cancer Registry, they have to show that it’s financially feasible, and for accessibility they have to have clinical criteria on who’s eligible. Patient selection and policies that show no discrimination on ability to pay; race, age, sex, and so on. They have to be accessible to the disabled. That’s a brief overlook of the standards.
Ms. Sonia Chambers: Then these are available on our website and this other document you’re going to reference either already is or soon will be on our website.
Mr. Dayle Stepp: It’s on the website.
Ms. Sonia Chambers: It’s on the website. Is it on the front page there with the list of the meetings and the documents?
Mr. Dayle Stepp: Right. It’s just an inventory of units within the state right now.
Ms. Sonia Chambers: 22 perhaps different sites.
Mr. Dayle Stepp: Correct.
Ms. Sonia Chambers: But there may be more than one unit at some of those, right? Because I see some of them…
Mr. Dayle Stepp: Correct.
Ms. Sonia Chambers: All right. Well, we’ll just open it up for comments, discussion. And the question is whether you feel the service should continue to be subject to Certificate of Need review or not. Gary, you haven’t been shy in any of these meetings. Jill, I was going to call on you, but I happened to look at Gary first.
Mr. Gary Murdoch: That shouldn’t stop you. Jill can go.
Ms. Sonia Chambers: And please come sit at the table guys, the peanut gallery there. I forgot to ask you to do that earlier, sorry. It’s kind of like church. Everybody chooses to sit in the back.
Mr. Gary Murdoch: A little different than church.
Mr. Dayle Stepp: We don’t have the choir.
Ms. Sonia Chambers: Oh, I don’t know.
Mr. Gary Murdoch: [inaudible] view is that CON is needed for this type of technology and I guess I would offer maybe a few other comments that look at the list of 22 sites or how many units there are. Just as we do need methodology in trying to figure these things out, there’s two or three things emerging. The stereotactic radiosurgery, CyberKnife, Gamma Knife versus basic linear accelerators beneath for all three of those and the cost of all three of these things. I think there needs to be some sort of oversight to make sure that we disburse these appropriately throughout the state. This technology…we were just talking about changing…every two years we look at it. the needs of this thing keeps changing and so I’m not sure how we’d deal with the needs methodology, but I think there does need to be some other…
Ms. Sonia Chambers: So what you’re saying is that we might need to look at the need methodology for those more highly-specialized types of radiation therapy differently than a regular linear accelerator?
Mr. Gary Murdoch: One way or another you’re going to have to look at it, but yes, I think there some differentiation between some of these technologies whether it’s a Cobalt 60 200 sources to the brain or radiosurgery to the prostate or basic linear accelerated six-week treatments of radiation. I’m not physician and I’m not a clinician, but there are differences in these types of things.
Ms. Sonia Chambers: Okay. Dr. Whaley?
Dr. Lewis Whaley: Well, I would certainly agree with what the University Hospital, [unintelligible] in Morgantown. I think that the methodology, to look at the methodology from my perspective, I think there’s some flaws that crept into the methodology from when we first…the last time we looked at it, which was about four or five years ago. While is has not been discussed in depth, one of the issues was that, and I would need to sit down and look at it closely, but out of that came the perception that actually the more machine…there was a perception that the more machines you had the greater the need that would actually be created, when in reality the reverse, in my opinion, that they looked at as far as what was the actual utilization on current machines prior to approval of a new facility. With that to the side and I would certainly agree with him that the issue of newer technologies that are emerging probably need to be addressed. He touched on three things that seem to be…that are here and have been on the horizon for awhile, Gamma Knife for treatment of brain lesions, CyberKnife for treatment of brain lesions versus stereotactic radiosurgery with the conventional linear accelerator. Our group has been doing stereotactic radiosurgery of the brain longer than anyone in the state. We go back six or seven years, even before Morgantown got a Gamma Knife. Our clinicians in the group, who are five doctors in the group, are from varied aspects all over the country. All of us trained at different locations. All of us have experience with one of the modalities, if not multiple modalities, and the bottom line is that clinically the results are essentially the same. The real issue is cost in producing the product and what’s necessary in order to secure, maintain, and provide staffing for different types of machines. The linear accelerator versus the Gamma Knife versus the CyberKnife, so those are all issues and I think the idea of revisiting standards perhaps for more technical modalities that have begun to emerge may be worth prowling. I certainly wouldn’t dispute that at all. The overall issue, the bigger issue here, the question was should Certificate of Need services continue for radiation services in general in West Virginia and certainly I take the position that they do, but this is, as you’re well aware, a very costly venture to put forth and provide these services. It’s costly to set them in place, it’s costly to maintain the services from a staffing standpoint. They’re very specialized and the people that need to be involved…we need to have a medical physicist, as was mentioned by Mr. Stepp, ideally to have those symmetry people on site and specialized technologists that are trained to operate the machines. What has happened over the last five to six years is that there has been a shortage of qualified people in all of those fields, not just here but across the country, and that has resulted in almost a musical chairs every six months with respect to salaries that are paid necessary to keep these people employed. To give you an example, when the Capital Huntington facility went online it set off a movement that effected five or six centers here throughout the state because one person left to go to Capital Huntington, people went up there from St. Mary’s to go to Capital Huntington. As a result, someone came from across the river in Ohio to St. Mary’s and we lost a couple of people to them and the only way to keep up with that was an escalating salary scale. The technologists and the physicists are aware of that. I read a study about three months ago that the average physicist every six months gets a new offer for a new facility and every time they change jobs their salary increases about 15%. Well it’s impossible to keep up with that kind of demand. You have to become resourceful and try to provide some other perks or prerequisites of the job. Our chief physicist, on a salary basis, hires in the new physicians that start out in our group. Many students that come through our department, if you’re smart, that’s the direction you’ll go in, but the bigger issue is that, as I see it, is that we’re in a state that’s rural in nature. I know in our own practice we have a higher than normal percentage of patients that don’t have the ability to pay for services or Medicaid or if they have anything, a higher percentage of patients that are Medicaid and what becomes necessary in order to provide a high level of services is the ability…the benefits have to come from somewhere and my concern is that if the CON went away for radiation services, you would find groups that would move in. For instance in Indiana, I don’t know if Indiana is a CON state, Indiana, Kentucky, one of the states is not a CON state. The urologists have gotten together and said look, we’re going to form our own radiation centers and we’re going to send all of our prostate patients there. Urologists own this center, which has raised [unintelligible] issues by the state, but apparently they tiptoe through the tulips irregardless of that. What that has resulted in is that community hospitals that are in a setting of providing healthcare for patients for other modalities that don’t pay the bills, that are lost leaders…for instance, if pediatric services or women with cervical cancer, which we didn’t have a higher incidence of in West Virginia…did I hear someone was here from the Cancer Registry or…I know typically they’ve been at some of these meetings, but you see where I’m going is that what happens is it removes revenue that’s necessary to provide services to those that don’t have the ability in order to pick those services up. That would be my big concern that if CON went away here that we would have groups who would try and cherry pick certain services, much like we had with lithotripsy [unintelligible] lithotripsy was an issue within the cost, so in summation, I pretty much know that it’s warranted in that regard. The issue of looking at the standards may not be something that’s out of bounds or something that surely that we shouldn’t look at and try to update with what’s going on now. Any questions?
Ms. Sonia Chambers: Okay.
Mr. Dayle Stepp: Do you treat your brain tumors with just a linear accelerator that’s…
Dr. Lewis Whaley: We have some patients that require…that are treated with linear accelerators…
Ms. Sonia Chambers: Before you get into that, I actually have some similar questions while we have you here, but what I’d like to do first, before we get to that specialized area, is let everybody have their say about CON or not and then whoever would like to stay and have some of that discussion, because I was very interested in that whole concept of how you treat these brain lesions and the difference between…the different technologies. I think those of us before whom some of these applications have kind of come would like to be a little more educated, by why don’t we let everybody have their say about CON generally first for the radiation therapy and then I would like to pursue some of that. Bill, want to make any comment?
Mr. Bill Wright: At a high level or conceptual level, Radiology, Incorporated would favor the continuation of CON oversight for this area.
Ms. Sonia Chambers: Favors continuing?
Mr. Bill Wright: Yes.
Ms. Sonia Chambers: For this area, okay. David Jarrett? He’s got to find the un-mute button.
Mr. David Jarrett: We don’t have any comments today. I’m just listening in.
Ms. Sonia Chambers: Okay. Jill?
Ms. Jill McDaniel: Hello. I represent the West Virginia Hospital Association representing 74 hospitals and health systems and we do have a position in support of continued CON review for radiation therapy services. I think Dr. Whaley and also Gary Murdoch very well articulated the reasons, some of the reasons why we support CON, and obviously assuring adequate volume of this expensive technology is critical for reasons to maintain high quality services, as well as to keep healthcare costs low.
Ms. Sonia Chambers: Okay. Bob O’Neil?
Mr. Bob O’Neil: I don’t have any comments.
Ms. Sonia Chambers: Ed?
Mr. Ed Hamilton: CON should continue, the reason being essentially what you just heard from the Hospital Association. It makes no sense to take the revenue stream that’s available to pay for these services when some of them may be just kind of limping along anyway and split that revenue stream and send part of it in another direction. The long and the short of it is the additional investment in equipment sometimes will never be recovered. Therefore, in a rate-regulated state for institutions, it goes straight to the bottom line in higher cost per day at that institution and we can’t support that. They can’t afford it either, can’t support it first.
Ms. Sonia Chambers: Raymona?
Ms. Raymona Kinneberg: You skipped Amy?
Ms. Sonia Chambers: I thought I’d do you and then Amy. I’m just skipping around. It keeps you on your toes.
Ms. Raymona Kinneberg: On behalf of Logan Regional Medical Center and RTSI Radiation and Therapy Services, Inc., which has one facility here and has CON approval for two others in terms of acquisition, so in terms of developing them…
Ms. Sonia Chambers: And in what locations?
Ms. Raymona Kinneberg: Greenbrier County and Logan County. Their existing facilities…
Ms. Sonia Chambers: Okay.
Ms. Raymona Kinneberg: For all the reasons that have been said…there’s a volume issue that’s related to quality and it’s important that there be sufficient volume so that you can maintain quality at a facility and the comments made by Dr. Whaley, in particular, on resources, which are limited. Additional facilities would further divide those resources and make it even more difficult to maintain the staffing level, specialized staffing levels that are needed, and for all of those reasons we support continued CON for this area. It’s a really specialized service and we want to make sure that the quality is there for people that have to receive it.
Ms. Sonia Chambers: Amy, do you have any comments?
Ms. Amy Tolliver: We don’t have a specific position on this service at this time and I’m just here to listen.
Ms. Sonia Chambers: That’s why I went to you, Raymona, before Amy. I thought that’s what she might say.
Ms. Amy Tolliver: But we’re going to hold out. We’ll surprise you later.
Ms. Sonia Chambers: There you go. Martha, just happy to be here?
Ms. Martha Morris: Taking notes.
Ms. Sonia Chambers: Pat or Stacy from Medicaid?
Ms. Pat Woods: We agree with continuing the CON.
Ms. Sonia Chambers: Okay. Anybody I skipped who wishes to make a comment? No? Okay. Questions of anybody’s who has spoken? I probably have a general question that I thought Marilyn…following on some of the questions Marilyn has made in the past, unless you have the very same question.
Ms. Marilyn White: No, go ahead.
Ms. Sonia Chambers: A lot of, I think, what has been mentioned in terms of keeping CON has revolved around revenue and being able to support the service and I guess my question relates to are there certain thresholds that are really crucial for quality in terms of volume or is it all just about money?
Dr. Lewis Whaley: Well, I can speak for our department. We’ve always held that full-time physics support, full-time dosimetry, and full-time technology support is essential to operate a facility as opposed to someone being a part-time advocate or a participant in what goes on in that facility and I know that in our facilities in the state they have part-time people who come through, possibly because they can’t afford the volume, but I cannot imagine, if you’re not familiar with nearly all the facilities in the state, I cannot imagine that the ability, with possibly the exception of Logan, [noise-inaudible] does not exist. The physics component is essential to make sure that there are no errors [unintelligible] that take place in these pockets of treatments. It’s also essential to make sure that the treatment that you’re giving is giving them the most optimal manner possible and by using those terms I mean in a manner to minimize the side effects that go along with radiation. Certainly when you…and one of the differences we’re going to talk about a little bit later…you asked me about stereotactic. Stereotactic involves giving them large doses of radiation in one setting, much more so over a conventional series of treatments. As a result of that, with a large dose the damage from a catastrophic error, or damage from an error in calculations, would be catastrophic and the only way to minimize that is to have a full-time physicist. The American Association of Physicists in Medicine recommend a full-time physicist be available on a day-to-day basis for calculation and treatment of stereotactic procedures. The broader the range of services that you have to provide, whether it’s pediatric care, whether it’s brachytherapy care and brachytherapy is the process that’s used frequently in treating cervical cancer, from brain cancer lesions, anything over and above the routine things that we see on a day-to-day basis for common things such as prostate and lung cancer, breast cancer, requires some level of specialized expertise, certainly from the standpoint of for instance in treating children, pediatric cases, we don’t have that many, we [unintelligible], but it’s essential that those patients have the ability to be treated there or in Morgantown. In and of itself, the revenue from treating those patients does not support those services. The level of complication in delivering the radiation to those patients is much higher than what it would be, say from someone with a simple lung cancer and as a result, the manpower from that ancillary support staff, the need for that is much greater. Does that make sense? Do you follow me? So I don’t think it’s purely a matter…it’s not…I’ve heard somebody say it’s always about the money, but in the vernacular, but it’s not really, at least in our profession and the people that I’ve been exposed to in the state of West Virginia. It’s about the quality of patient care that most people look at.
Ms. Sonia Chambers: So it has to do…let me make sure I understand this. You have to have an adequate volume in order to support staff, full-time staff.
Dr. Lewis Whaley: Absolutely.
Ms. Sonia Chambers: And full-time staff equate to…I don’t know equate…full-time staff are highly correlated with quality because you have that and is that because with the physicist and the dosimetrist, every time the patient comes in that physicist or dosimetrist is involved in determining the radiation and making sure the machine does only what it’s supposed to do? I’m not a clinician, so I’m…
Dr. Lewis Whaley: I think I know where you’re going. On a day-to-day basis, the patient is getting a series of radiation treatments and it may go three weeks, it may go six weeks. There are issues every day of the week that come up with respect to something that has changed about that patient’s treatment, whether the patient has lost weight, something, the dose that was calculated is going to be a little bit different, whether it’s an issue with calibrating the machine each morning, calibrating at the end of the day. We calibrate our machines in our department three times a day. They’re calibrated in the morning, they’re calibrated during the lunch hour, and they’re calibrated again at the end of the day, late afternoon. If someone’s not there full time, those things don’t get picked up and if they don’t get picked up for three or four days, then that’s an issue that impacts on patient care. There was a facility here in the state that I’m aware of that 15 years ago had a part-time physicist that was there day a week. One of the energies on the electrons, energies had not been calibrated properly and it was not picked up for a year. That was not a catastrophic event in and of itself because the electrons weren’t something that are used as intently as some of the other modalities in radiation, but it serves to highlight what can go wrong in the absence of someone full-time on staff and you do have to have an adequate volume on a daily basis to support the presence of someone there. If you don’t, then financially you’re not going to be able to do it.
Ms. Marilyn White: On that, can I just ask a question? The incident that you’re referring to, how was that discovered? What governing board, because I was sitting here thinking I don’t think the CON had anything to do or didn’t find this out. I mean it’s a quasi issue, but who discovered that and who took care of it? Who was responsible?
Dr. Lewis Whaley: Well, are we still on the record?
Ms. Sonia Chambers: Yes.
Dr. Lewis Whaley: I realize that. Let me say this, it was discovered indirectly on our part, it came to us. It had nothing to do with the facility where we treated or didn’t treat. Our physicist at the time was asked by an out-of-state facility, across the river in Ohio, to consult on a project that they had going on and the physicist that was the part-time physicist for that facility was also the part-time physicist for the facility here in the state of West Virginia. At that time we became aware of it.
Ms. Sonia Chambers: But the issue is not that…
Dr. Lewis Whaley: There were no patients harmed to our knowledge by that, but it was less than adequate treatment and the potential for someone to be harmed if…I mean someone could get harmed with electrons, but the whole reason I brought it up is that there are checks and balances that need to go on constantly as part of this process.
Ms. Marilyn White: Were most of these located in a hospital? I think I counted three maybe that I think aren’t [noise-inaudible] the monitoring, the making sure, that all of these things that we’ve addressed here under quality are carried out. Do the hospitals take that responsibility? Do they make sure that all of this is going on, because I know we don’t? Who…
Dr. Lewis Whaley: Well I can speak for our own facility. Now we’re based at CAMC. We’re a separate entity from the hospital, but we have a contract with the hospital to provide services for the hospital. We are actually subject to JCHA inspections because of our alliance with the hospital and their inspectors come to our department and they do all of our data and we also make that data available to the hospital on an ongoing basis. I can’t speak for other facilities, but most, even the facilities that aren’t operated directly by a hospital, I think all of them are pretty much, if not on campus at the hospital, are close to a facility in the hospital. [Unintelligible] those clinicians constantly do backups [noise-inaudible].
Ms. Sonia Chambers: But your point about quality is not…I guess, to tie Marilyn’s question, the other part of her question and your comment together, the Certificate of Need process in and of itself would not insure or catch quality issues like the calibration of equipment, but I guess your point was that you’re much more likely to have those kind of issues taken care of if you have the volume to support a full time physicist and dosimetrist? Is that correct?
Dr. Lewis Whaley: Absolutely, correct.
Ms. Sonia Chambers: So it’s an indirect relationship as opposed to a direct one.
Dr. Lewis Whaley: That’s correct.
Ms. Sonia Chambers: Other questions along the general line before we get into Gamma Knife, stereotactic radiosurgery and CyberKnife?
Mr. Dayle Stepp: I was just going to ask the doctor, you treat brain tumors with your linear accelerator, right? You don’t have to have a Gamma Knife or a CyberKnife or…
Dr. Lewis Whaley: We have the XKnife and…
Ms. Sonia Chambers: XKnife…okay.
Dr. Lewis Whaley: And I will explain when everyone’s ready…if I had known I was going to be put on the spot I would have called around and made sure we showed up with an army, but…
Ms. Sonia Chambers: Well, I am sure there will be lots of opportunities to have more specific discussions about this, but we thought while we had you here we could ask you. Any other general questions about anything, any of the commenters have said?
Ms. Sheila Kelly: I have a question. I’m wondering if the need methodology that we use, which is the 60%, 350 patients from the region that the patients are drawn from, in your view, your guys that are in the field, is that a reasonable need methodology or does that need to be different?
Dr. Lewis Whaley: I think possibly that needs to be looked at. Now with the point I made earlier, there are newer machines coming out that have the ability to treat much faster, but that’s on the horizon…
Ms. Sonia Chambers: But in the garden variety linear accelerator?
Dr. Lewis Whaley: I’m of the opinion that the methodology was flawed when it was put together the last time.
Ms. Sonia Chambers: No, but I guess I’m asking you, you are talking specifically about linear accelerators, not Gamma Knife, CyberKnife, XKnife?
Dr. Lewis Whaley: That’s correct.
Ms. Sonia Chambers: So the technology is evolving such that the newer linear accelerators are faster?
Dr. Lewis Whaley: They will be faster by…some of the products are just now making it to the market. What that means, potentially and if we calculated a machine, not have 25 or 30 patients a day to be operational. You may be done in four hours treating 25 or 30 patients and so suddenly you can treat 50 or 60 patients. That’s coming.
Ms. Sheila Kelly: And the number of patients that you’re treating a day now per machine tends to be 25 or 30?
Dr. Lewis Whaley: It averages somewhere between that, 25 or 35 patients per day.
Ms. Sheila Kelly: Do you have waiting lists or is there a problem with patients backing up or machines running over eight, ten hours a day or…
Dr. Lewis Whaley: In our facility there has not been, because we…cancer treatments are cyclical. Right now we’re in the down period. Typically before the holidays we see something of that nature. In the spring things tend to pop up.
Ms. Sonia Chambers: Why? People don’t want to admit they have cancer before the holidays?
Dr. Lewis Whaley: Nobody wants to go in and…
Ms. Sheila Kelly: I’ll wait to get sick till after Christmas?
Ms. Sonia Chambers: I’ll wait to acknowledge that I’m sick till after Christmas.
Dr. Lewis Whaley: Yes, absolutely, but to answer your question at our facility what we’ve done, we just start earlier and finish later in the day and right now the day starts about 8:00 in the morning and we’re done by 4:00. In the summertime we find gentlemen with prostate cancer, they want to go play golf, they want their life to continue and they say if you’ll open at 6:00 I’ll be here for treatment and we do that.
Ms. Sheila Kelly: So they can have their treatment and then go get their rounds of golf in?
Dr. Lewis Whaley: If that’s what they want to do and I’ve got patients that play every day during treatment for prostate cancer.
Ms. Sheila Kelly: So if the linear accelerators then developed new technology to become more rapid, then the 350 is going to have to go up logically.
Dr. Lewis Whaley: In my opinion, but as I said, they need to be reevaluated.
Dr. Marilyn White: But we almost have to have two sets of standards, because it’s going to depend on the type of machine.
Ms. Sheila Kelly: And every hospital’s not going to have that best choice to start with.
Dr. Lewis Whaley: Not to start with, but I think down the road. The other advantage to that is, one of the issues I mentioned earlier was the huge cost of maintaining technologists and support personnel. For every machine you’ve got to have more people that…we currently employ 13 radiation therapy technologists and there’s a shortage. We hold on to more people than what we need because we know that we could go from having two or three more than what we need to being two or three short in just a matter of days. The advantage to that is obvious, but it’s a cost issue. If we had a machine that ran quicker and would use the same number of techs, but treat twice as many patients, that would help reduce those issues.
Ms. Sheila Kelly: So are you saying at some point there’s going to be a Darwinian survival of the fittest here of who can sustain the staff and the number of patients?
Dr. Lewis Whaley: I don’t think that, but I think it’s constantly an evolution. We have a program in Morgantown that graduates four graduates a year. Two years ago we went…the University of Alabama has a program that graduates about 16 a year. Two years ago we went to the University of Alabama and hired four of their graduates. We hired three people that same year out of a program in Georgia simply because we knew that we were going to lose some along the way. We have historically carried two dosimetrists. That’s all we need to operate our department and a dosimetrist is sort of in between a technologist and the physicist. A couple of years ago I had the opportunity to hire a third because I had some concern that we might lose a dosimetrist. I knew we needed two and I thought well, we’ll bite the bullet and pay for an extra dosimetrist. The average mean dosimetry salary was $82,000, so it’s an expected proposition to hold on to somebody like that. Well, in one week’s time, Capital Huntington hired one of my dosimetrists, okay? I went from paying someone who was making $82,000 a year, which was the mean for this area, and paying them $105,000 a year, okay? The following day…I’m down to two dosimetrists. The following day my second dosimetrist that’s left got a job offer for $95,000 from a hospital in Columbus. The only thing that saved me, that I was able to hold on to him by was sitting down with him and said look, you need to look at what the cost of living issues are going to be in Columbus versus Charleston, West Virginia, but the bottom line is that there was this escalation that really is still going on. This was back in the summer with the dosimetry issue. I would like to see some kind of leveling out of personnel and playing fields. Back to your original question about the faster machines and if there’s going to be a Darwinian situation, I think that there will be a balance that’s ultimately obtained, but as she pointed out not everyone’s going to be able to afford a machine that runs twice as fast. The price tags of the machines are about twice what the regular radiation machines are, but you sit down and you factor up am I going to need this many technologists and it’s not a matter of well we’re going to lay these technologists off, we know we’re going to lose them by attrition sooner or later.
Ms. Sheila Kelly: I guess what I’m saying is that we have to come up with some kind of methodology to look at how are we going to justify approving more sophisticated machinery that is going to add cost burden to the system, but at the same time treat more patients more expeditiously and that’s going to be a discussion about different kinds of need methodologies, I would assume.
Dr. Lewis Whaley: I agree. Those are valid concerns and when the time comes, I think you’ll need some expert input in this to be dealing with standards.
Ms. Sheila Kelly: And you’re saying that this methodology will probably come to the market in the next five years for sure or much faster than that?
Dr. Lewis Whaley: It’s being advertised now. The machine is kind of like an automobile. It’s got an accelerator on it as to how fast you can run it and the newer machines are more like Ferrari’s compared to a Volkswagen.
Ms. Sheila Kelly: And the cost is proportionately equivalent.
Dr. Lewis Whaley: Yes.
Ms. Sonia Chambers: Other general questions? All right, let’s move on to the more specialty… Anybody who’s not interested in the discussion can either hang up on the phone or leave and do other things. So I guess my general question while we have you here is can you educate at least me, and I think probably the Board generally, from the non-clinician standpoint about treating, I guess, treating brain lesions, brain cancers, whatever, with the different modalities, Gamma Knife versus CyberKnife versus XKnife versus…we just need a little education if you don’t mind.
Dr. Lewis Whaley: Does this think work?
Ms. Sonia Chambers: No, you can’t write on it. Do we have…I think there’s one in the small conference room. That’s a smart board and you can only write on it with certain things and our techy guys will come busting through the door if you start drawing on it.
Dr. Lewis Whaley: All right, well let’s…and I don’t want to put anybody to sleep and I want to try to make this as simple as possible. We have medical students rotate through our department all the time and from a lecture standpoint, medical students have very little exposure to radiation oncology services, so I’ll start out by just giving you some basic descriptions of what takes place.
Ms. Sonia Chambers: Well I guess, Dr Whaley, some of our questions, as you know, we have had before…well, Morgantown has the Gamma Knife. St. Mary’s came through and told us that they absolutely had to have a CyberKnife and so now Cabell tells us they need a Gamma Knife and so we’re sort of faced with a little bit of this dilemma.
Dr. Lewis Whaley: And Pittsburgh has a Gamma Knife long before Morgantown had one and the University of Virginia in Charlottesville was the second facility. They have a Gamma Knife also.
Ms. Sonia Chambers: Well I have no idea what you may come through and ask for, although you have an XKnife, which I don’t if that’s something new or different or what, so…
Dr. Lewis Whaley: Well we’ll explain it. But in a nutshell, let’s take just a minute or two to talk about what radiation is because I’m going to tell you what the similarities are. The smokescreen that’s generated as far as the differences, the sexy names, CyberKnife, XKnife, Gamma Knife, is a result of marketing on the part of people that manufacture these machines that want to sell somebody something, okay? The bottom line is that radiation is radiation, okay? It’s a high energy…when the medical students are with me we use a symbol that kind of looks like this. It’s a high energy x-ray beam that’s directed…it’s got to come out of a machine whether it’s CyberKnife, whether it’s a linear accelerator, or the XKnife, or whether it’s a Gamma Knife, okay? The end product that comes out of all three of these machines is a radiation beam and the beam has an energy. Right now in this room there’s radiation coming out of the lights, there’s radiation from FM radio station 99.9, it’s all around us. There’s radiation in our cell phones, cell phone signals. They all travel in this sign wave [noise-inaudible] arrangement. The bulk of the radiation has no damage at all. The wave lengths are such a long wave length that they don’t do anything, but when the radiation gets so small on the wave length that they’re pressing one peak to the other, it adds the ability to penetrate through the tissues and actually penetrate cancer cells and damage the genetic information of the cancer cell to the point that the cancer cell dies. Ironically, on all three of these modalities that we’ve talked about; XKnife, CyberKnife, Gamma Knife, the radiation is…basically it’s generic radiation. There’s no real differences in what’s coming out of the machine. There are minor differences in the energies. What is different is the way that the radiation is twisted and turned, okay? To put this in perspective for a brain tumor that required treatment with a conventional linear accelerator, the daily dose may be in the order of something called 200 centigrade. A centigrade is the measurement that we use to describe the quantity of radiation. Just like you go to the store and get a loaf of…get a pound of bologna. You know if you’re from Fayette County you’re used to going…a dozen eggs or a gallon of milk, two pounds of butter, there’s a quantity involved with radiation. To successfully treat cancer cells, for each different type of cancer that occurs within the body, there is a known quantity that appears to be the most effective and the goal is to deliver that quantity of radiation while at the same time minimizing damage to normal tissues around it. Now fortunately, normal tissue has the ability to repair radiation damage to some extent, not completely. That’s why we give patients a break every so often in their treatment, so that the normal tissues can catch up and it just so happens that the break works out nicely to do it on Saturday and Sunday, but it doesn’t have to be. So radiation coming out of a machine is pretty much always the same. It’s the quantities that are different. For routine, conventional courses of treatment the typical dose is about 200 centigrade a day. I hear about 15 or 20 years ago, the idea came up with taking what we refer to as collimators for taking the beam and sharpening it, making it real sharp. For instance, making it pencil thin. They started out with the Gamma Knife and they wanted a pencil thin beam and they thought well, if the beam is pencil thin then we can pass it through tissues to deep seated tumor and because the beam is not real wide we’re going to minimize damage as we go through…am I making sense here? And therefore we can give a much higher dose than that 200 centigrade dose that I spoke about earlier. And if we can give a much higher dose in one setting, then we can reduce the total number of treatments. The precision that was required in order to accomplish that is how the Gamma Knife was developed. Now the Gamma Knife produces the radiation by radioactive decay of a Cobalt source, but as compared to a linear accelerator, which produces the radiation artificially…but guess what? If you’re standing across the room, the radiation is the same. What makes it different is how the beam is kind of squeezed together to make it pencil point so that we can give a high dose in one setting. We can give a high dose in one setting, to answer your question, with a conventional linear accelerator by collimating or shaping the beam into a nice fine pencil arrangement. The advantage to that over the Gamma Knife is that you’re able to take an accelerator that’s already in existence, you’re able to take a piece of equipment that’s being used to provide other services for one cancer, prostate cancer, cervical cancer, to treat pediatric cases in the pediatric department, you’re able to spread your resources out further and what happens is if we take a linear accelerator in that setting and buy it some special equipment, which is relatively low cost…I think the XKnife package was about $400,000 or $500,000, but 99% of what was done with the Gamma Knife can be accomplished with a linear accelerator with an XKnife-type of package on at a minute amount as far as cost investment. On top of that, you’re not going out and hiring a physicist just to cover the Gamma Knife and to provide the services to keep it up and running as an extra piece of equipment on a day-to-day basis. The CyberKnife…again, I want to emphasize that what comes out of the CyberKnife is the same thing. It uses just a little bit different method to shape that beam down into a pencil point beam where can bump the dose up from 200 centigrade on a daily basis to in order of 1000 centigrade. All that’s well and good and we were doing it before they were ever treating with Gamma Knife in Morgantown. We were treating with the XKnife here in Charleston. There are XKnife’s or XKnife-type packages available at other facilities around the state. I think they may have one in Clarksburg. I know they were looking at getting one. The people at Parkersburg, they have one, but my point being that it’s a relatively non-expensive arrangement to essentially provide the same type of service. With respect to the CyberKnife versus the Gamma Knife, there is no clinical advantage of one machine over the other, other than you may make the statement that the CyberKnife may have a wider use outside of treating brain tumors than what the Gamma Knife does. Everything the Gamma Knife does, the CyberKnife can do. Don’t let somebody fool you into thinking that it’s different and the vendors, the people that manufacture the machines will throw up a smokescreen, but their goal is obvious. Now what’s happened here in our part of the state is that the CyberKnife people, and I’ll throw down on everybody. What we have now is the CyberKnife people are going…they’ve approached us and we’re like we can’t justify spending four million dollars on a piece of equipment, so what they’ve done is they’ve gone to the surgeons, they’ve gone to the neurosurgeons, and the chest surgeons and saying look, look at what these advantages would be to you. Here are special codes that if your patient was treated on a CyberKnife that you would be able to bill and receive reimbursement for, so in turn they come back to us and put pressure on us, wanting us to move in that direction, so there are a lot of moving parts to this equation, but the bottom line is radiation is radiation. The only thing that makes it different is how well it’s collimated and all three modalities have the ability to collimate the radiation down and once it’s collimated down, then you’re able to bump the dose up and escalate the dose. We’ve had that capability and we’ve been doing it, we’ve been treating patients with the XKnife for the last six or seven years. Patients get treatment in a single setting, they get one treatment, and then they go home. The major problem, potential problem is that if something goes wrong, you’re going to have a catastrophic injury on the part of a patient and that’s why it’s so critical to have adequate support, full time support in the form of a physicist, a technician who’s not being cross-trained, that morning that treats somebody on the pediatric machine and come in that afternoon and treats somebody’s brain. That’s totally different, so the complications can be different. Any questions?
Ms. Sheila Kelly: Is it any more catastrophic if something goes wrong with an XKnife, it being a linear accelerator, than it would a Gamma Knife being non-linear accelerator?
Dr. Lewis Whaley: The rate typically is given a little bit slower with the linear accelerator, but the newer accelerators that are treating quicker, the differences may be, and I’m going to answer you question here in just a minute, is there any difference between the catastrophic damages, the patient may be on the table, I’m going to point this out, a little bit longer with the conventional linear accelerator. They may be on the table for 30 minutes as opposed to 20 minutes with the Gamma Knife, but the end result is the same. Now you’re question to me again, was…
Ms. Sheila Kelly: Is it any more catastrophic if something goes wrong with the linear accelerator, XKnife, than it is with the…
Dr. Lewis Whaley: No, the same potential…
Ms. Sheila Kelly: Catastrophe is catastrophe.
Dr. Lewis Whaley: The same potential for something to go wrong exists. That’s why it’s important to have people that are adequately trained.
Ms. Sonia Chambers: Can you un or de, I’m not sure which is correct, prefix, collimate the radiation from a CyberKnife? What you were saying is you take your regular linear accelerator and with this four or five thousand dollar software package…
Dr. Lewis Whaley: It’s a four or five hundred thousand…
Ms. Sonia Chambers: Hundred thousand, sorry, package…
Ms. Sheila Kelly: A 1200 to two million dollar threshold…
Ms. Sonia Chambers: I noted that. You can collimate it down and do essentially the same thing by decreasing the width of the radiation, you can bump up the dosage. With a CyberKnife can you do the opposite so that you can use it for…so it could have both applications?
Dr. Lewis Whaley: Not as readily. Now let me explain one thing that’s different about the CyberKnife. I’ve stressed the point that the radiation that comes out of all three machines is the same. The CyberKnife has this big robotic arm, that the actual unit that produces the radiation is on the arm and it moves symmetrically with the patient, okay, and the radiation beam shoots out at them, so it’s less optimal for things that require conventional treatment and some things are more important to treat conventionally because the side effect profile from certain types of tissue damages tend to increase as you give a higher daily dose and I’ve told you certainly that’s a problem with some things in the air, if something is not perfect about the way the machine is set up. CyberKnife is neat in that if a patient moves or breathes, you can do everything in the hands of the CyberKnife that you could do with a Gamma Knife. Anybody that will tell you different, it just ain’t so. The CyberKnife can treat lesions outside the head, in addition to the brain, and it can treat lung lesions, okay? As the patient inspires and a lung lesion may move around, then the CyberKnife is calibrated to move up and down to stay matched to that lesion, that cancerous lesion in the lung. Now there’s newer technology, which we have, that’s not very expensive in relative terms. It’s certainly not four million dollars worth of expense. This is about a 50 or 60 thousand dollar add on, I didn’t say a hundred thousand dollars, I said 50 or 60 thousand, that allows us to track patient movement via the patient’s respiration in order to treat lung cancer lesions, but we have the capability here in Charleston, to do what the CyberKnife does to other parts of the body without spending four million dollars. That is the bottom line in the avenue that we have taken in order to try to overcome that cost factor. If we had a large benefactor, somebody willing to donate money to us and throw it at us, then we could go out and buy equipment on a yearly basis. The problem with that is that the next thing I know is that my dosimetrist, who is an essential part of operating my practice and who is paid well, is coming to me and saying look, I’m in a bidding war. What are you going to do to keep me? They’ve offered me $105,000 down the road and if you want to hold on to me, that’s what you’re going to have to do. I can’t keep up with that. My costs are tied to what comes into the practice and what comes into the practice is necessary in order to treat the pediatric cases, treat the woman with cervical cancer from McDowell County, to treat the patient from up…I get patients from Welch, that drive from Welch and for some reason that seems to be the one spot in the state that…where it’s the most difficult for transportation to get their radiation facility in a timely fashion, but there’s not enough of a population base there to support…did I say Welch? I don’t mean Welch, I mean Webster Springs. I know it starts with a W. The people from Welch go down to Bluefield. Webster Springs is the facility I meant. But my point being, not to wander, is that in order to adequately treat everyone in the state, and I’m going to come back to this point again, the patient with lung cancer or whatever it is, they may or may not have the resources to cover those treatments, but ultimately it’s the mix and the total patients that come through that provide for everyone’s care and I would hate to see the state in a situation where they’ve changed.
Mr. Dayle Stepp: I’ve got a question. Is the CyberKnife and the Gamma Knife, because they are so focused, are they better for contained tumors than a linear accelerator where the cancer might be spread over an area?
Dr. Lewis Whaley: No, we can take a linear accelerator and pinpoint our beam just the same way that a Gamma Knife…
Mr. Dayle Stepp: The same focus width…
Dr. Lewis Whaley: We bring that down the same way. The technology’s a little different. The neurosurgeon may put a head frame on a patient to immobilize them because we can’t take a chance on someone even moving a millimeter. If the lesions are around the part of the brain where the optic chiasm or where the nerves are that go from the back of the eye all the way back, someone can…there have been well documented cases where people were blinded from just a single fraction of radiation. Your original question started out really was about treating brain lesions with…
Mr. Dayle Stepp: Right and you answered that question because of how you focused the linear accelerator.
Dr. Lewis Whaley: Well I want to point out that not every brain lesion is appropriately treated with a Gamma Knife or a CyberKnife or an XKnife. Some brain lesions require treatment of the entire brain volume, which means that you’ve got to be able to open the field up. The reason for that, patients that have metastatic disease from some other site, they may have one or two small lesions in the brain, okay, and we can take stereotactic radiosurgery procedure, XKnife, CyberKnife, or Gamma Knife, and treat those lesions, but we know that the fact that there are cancer cells in that part of the brain means that there are other cancer cells there also that have spread from a breast, from a lung, or whatever, and what good does it do to treat just those two lesions knowing that in two or three months down the road, that they’ll be two or three more. It’s like somebody walking out with a handful of seed in the wintertime and throwing it out on the grass. Well the fast growing weeds show up in the spring, but as the summer goes on you start to see more growth, so in those patients it becomes beneficial, in addition to giving them a CyberKnife or a Gamma Knife or an XKnife treatment, to give them a conventional course of radiation using the linear accelerator, treating the whole brain, not just a specific place.
Mr. [??] [??]: If Cyber or X knives for brains have a halo, how do you immobilize the patient and make sure you deliver…
Dr. Lewis Whaley: There are a couple of different devices depending on which generation. Some of them are halo bolted in, some them are an immobilization device in a bolt, the…
Mr. [??] [??]: Some patients you use currently now bolt-in, some you don’t?
Dr. Lewis Whaley: That’s correct. Now I’m speaking about our linear accelerator XKnife facility in Charleston.
Mr. [??] [??]: Yeah.
Ms. Marilyn White: I’ve got another question for you. All of these facilities listed here have got a linear accelerator, right? And listening to you I’m thinking hmm, if they all have this five million dollars it’s staffing that would be the problem, isn’t it, because if you can do basically…treat the same thing with your linear, maybe just a little bit fine tune it, so why couldn’t all of them have both…all three if they wanted, if they could afford it?
Dr. Lewis Whaley: That’s a good question, a very good question.
Ms. Sonia Chambers: Aren’t you glad you came today.
Dr. Lewis Whaley: The broad answer to that is yes. Now I don’t want to mislead you, because some linear accelerators that are older and have had a lot of use and wear on them, the mechanics are not precise enough to deliver the accuracy that’s needed and so not every facility…when Logan opened up, I think a CON was awarded to Logan almost 15, 18 years ago, the facility down there. They went out and bought a used piece of equipment that had been discarded out of a hospital in Atlanta and put it in place. It sat there for five or ten years. The hospital, at one point, or a group of physicians, spoke to our group about coming down and looking at it and one of our physicists and engineers went down to look at it. He said that the movement and the accuracy of the mechanics within the machine were so far off that there would never…that it would be impossible to upgrade the machine short of putting a new one in to do something like what we just spoke of.
Ms. Sonia Chambers: Amy you had had a question. Has it been answered?
Ms. Amy Tolliver: You had said that by upgrading the linear accelerator to the XKnife that it can do 95% of what the Gamma Knife can do and I was just wondering what the 5% is.
Dr. Lewis Whaley: Well for the XKnife package, there are some things such as arteriovenous malformations that are not treated as well with an XKnife, depending on what the size issues are, but they represent a fairly small proportion of the overall tumor picture and our experience here in Charleston has been that those patients have been referred up to Morgantown, which only makes sense. We don’t need a Gamma Knife on every corner. We don’t need a CyberKnife on every corner. In my opinion, if the price came down on a CyberKnife it certainly make it more feasible for at least some of the facilities around the state to offer those services, but it’s a relatively small proportion of things that can be treated with all three that can’t be treated at least on the linear accelerator. Am I making sense?
Ms. Amy Tolliver: Yes and in the new linear accelerators that are faster, the [unintelligible] that you talked about, like what are those prices?
Dr. Lewis Whaley: They’re priced at about…what’s the price of those? They’re going to go somewhere, fully equipped, between three and four million. The CyberKnife’s about four, I think, either 4 or 4.4. A conventional linear accelerator runs about just under two, depending on what’s available [unintelligible]. But the big issue is not, in my opinion, is not just acquiring a piece of equipment. As I stressed earlier, you’ve got to have people to run it right and do it right. It’s the same way with…there are a lot of services like that in healthcare. You can’t adequately do the job right by cross-training somebody to be here in the morning, be here at lunchtime, and be somewhere else at 3:00 in the afternoon to do a completely different procedure.
Mr. Dayle Stepp: I have one last question. Tell me what proton beam therapy is.
Dr. Lewis Whaley: Oh boy
Mr. [??] [??]: That’s twenty nine…
Ms. Sonia Chambers: He already knows how much it is.
Dr. Lewis Whaley: It’s much more than that.
Mr. [??] [??]: Well it was seventy-seven twenty five.
Dr. Lewis Whaley: We looked at that awhile back. Proton beam therapy…remember how I told you this…I don’t know if I told you this was an electromagnetic wave, it’s traveling through space. Remember I told you it’s the same thing as an FM radio wave, cell phone, the light coming on in a light bulb? The only difference is the difference between the wave length. An x-ray is so small that it can travel in between, but the energy is different in each of these waves and the smaller the wave length, the more energy. I tell my medical students, if you’ve got a guy with big, long legs and you’ve got a little short guy, and they both have got to get from here, where we’re standing together at one end of the hall, to the far end of the hall at the same time, the guy with the long legs is just kind of loping along. The guy with the little short legs is pouring it on and he’s burning up a lot more energy. Well these small wave lengths have a lot more energy in them and that energy is what’s giving up to the cancer cells that passes through to break apart the genetic material in the cell and kill it, keeping in mind this sign wave, this electromagnetic wave. A proton is a particle. This is something that’s invisible that translates E=mc2.
Ms. Marilyn White: Dayle, do you understand that?
Dr. Lewis Whaley: I have decided the equation E=mc2 factors greatly into this because it’s not a particle. With something that’s invisible, however it can be converted into mass, something you can hold in your hand. A particle is a speck of dust, it’s subatomic. It’s got physical mass to it. One of the advantages to it is that because it has a physical property, when it’s used, and it’s got energy and remember I said it’s energy that’s used to break apart the genetic material in a cancer cell, the particle has this energy and as it hits your skin it travels into the body, but the densities within the body just flat out stop it, so we can control that energy to such a point that I can say well I want to treat something that’s 10 cm below the skin and I don’t want the radiation to go on past it in any way, shape, or form. Whereas the top one, photon radiation, not proton radiation, we send a beam in, even with an XKnife, CyberKnife, Gamma Knife, what comes in the front, some of it’s going to go out the back side. It’s just the nature of how it works. There’s no particle there. You can understand if it’s a speck of dust or a piece of dirt or a rock, there’s going to be something that’s going to stop it and that’s what proton is. There are advantages to proton therapy. However, the clinical result comes out to be the same. I don’t care what…you know there are some minor differences. Parotid gland tumors were shown a few years back to be advantageous. Up until the advent of the former radiation called IMRT, and this is an educated crowd…
Ms. Sonia Chambers: We don’t have a choice…
Dr. Lewis Whaley: Proton therapy looked like it was going to be a great thing, but IMRT now has the ability to bend and shape external radiation or the photon beam in such a way that we can minimize the side effects. For instance, if we’re treating a prostate cancer with IMRT, I can bend the radiation beam around the rectum so that the amount of radiation the rectum is getting is very small compared to what it used to be. The advantage before IMRT, people said well we can take a proton beam, that particle, that speck of dust, and we can use it to precisely hit just the prostate and we’ll avoid the rectum. Well now some radiation was going to get in the rectum, but not nearly enough. Well guess what? The IMRT has essentially done, almost the same thing the proton beam was doing. The only advantage would be in the form of side effects, okay? But with IMRT, that advantage is very small. The major disadvantage on proton beams is that the facilities…you’re looking at 75 to 150 million dollars to build a facility. Ohio State University contracted to build one about six years ago and after about two years they withdrew the bid and cancelled it, because there’s no way that healthcare can afford to support those facilities. I don’t care even if they go to 20 million dollars a copy, there is no way. I got called in by the administration of CAMC and they said guess what? We went out west and looked at a proton beam facility, we think we can build one here, and then everybody’s going to want to come here, because they don’t have one in Virginia, they don’t have one at Ohio State, and of course I knew they’d already cancelled the one at Ohio State, and everybody’s going to want to come in and we’re going to have an industry. We’re going to build a motel bigger than what we have and we’re going to treat people from all over the east coast and I said well who told you this? Number one, the reimbursement for proton therapy is only like three times what it is for radiation. There’s no way that you can even come close. Have you sat down and looked at the numbers? Well, we went out west with some people from Wall Street that came here. Actually it was some people from Merrill Lynch and it’s very appropriate that they…they were looking to put together partnerships around the country with some technology that originated out of M. D. Anderson Center in Loma Linda in California and go around the country and build these facilities, suck the revenue off back to Wall Street, and put these things in places for hospitals and the hospital was going to be able to pull out ancillary services to make it worth the hospital’s while to get involved. Well guess what? Where does the money come from that goes to Wall Street? From the state, from Medicaid, from Medicare. There is no way, in its current form, that proton therapy…that this country can support the cost associated with proton therapy when the benefit is so low. Does that help to answer your question? You got my editorial along with it.
Mr. Dayle Stepp: There’s already five of them up operating, the new PMC’s work together. I know hospitals in Michigan have formed a consortium to do this because of the hundred and sixty million dollar project. Why are they spending this money when the outcome is not going to be measurably different?
Ms. Sonia Chambers: Because the Wall Street guys have convinced them.
Mr. [??] [??]: If I may, having a slightly different perspective, I’m in basic agreement with everything you’re saying. I had flashbacks to when we had our physicists, neurosurgeons, and radiation therapists talking about the Gamma Knife and there is some other space, some other things that I’m in basic agreement with everything you’re saying, but the proton beam…whenever the country had a lot of venture capital, there was a lot of things…this is the next best thing and you could have 10,000 people a year come in and pay $10,000 per episode and it’s going to be great and there’s a lot of energy on it. Why I think we have five or six in the country right now, my understanding is the Federal government decided to do demonstration projects for four or five sites and that was some of the seed money. We actually got approached a little differently than you, but we convinced ourselves that if somebody gives us about fifty million dollars this might make sense, but until we get that fifty million dollars, it makes no sense at all. That was basically our position in Morgantown and I think that was when we thought that it was eighty to a hundred million to get in the game. Now I do believe it’s down to forty to sixty because it’s just [unintelligible] are changed, but I think the entire country probably only needs a half dozen of these and then there’s still a debate whether that’s even needed and you might take the other side of that.
Dr. Lewis Whaley: The support personnel go up logrhythmically.
Mr. [??] [??]: Well it’s three to five million just to keep the lights on before you get anything going, but you need a revenue stream just to keep it going, but it goes back to the same thing whether you need physicists and whether they’ve got stereotactic radiosurgery and such like that, the same issues…you need a critical map to have a quality program, unlike hearts. There’s not like a 200 number that makes, that has a census around it. You need a physicist and then you need some collegiality. You some internal debate between your surgeons and radiation therapists as to maybe this is a surgical candidate, maybe this is a radiation therapy candidate, maybe this is a stereotactic surgery and that’s what the quality in my mind looks like, getting a program, and this thing is changing every two or three years. I think we would agree on that with this thing looks like its two to four years now, but two to four years ago it was significantly different.
Dr. Lewis Whaley: But you know what? The bottom line is what comes out of the machine is still the same as it was 30 years ago when the project…it’s still radiation.
Ms. [??] [??]: The question is what to do with it…
Mr. [??] [??]: We can bend it around to get to the prostate. How your software reconstructs the dosing and how a physicist plans dosing, that is what’s changed. The basic, how you deliver, the energy delivered to the brain from…again, that was the debate that we had internally and that doesn’t change a bit. [Unintelligible] delivered it and then the noise out there from vendors, that changes every two years, but there is some…the way you can bend something around to get to the prostate now is a lot different than it was four or five years ago, you would agree with that one absolutely and what it will be five years from now.
Dr. Lewis Whaley: That’s IMRT…has really kind of filled that void and taken the wind out of that argument that everybody needs protons.
Mr. [??] [??]: Yeah, how you basically protect the tissue around the site by either bending or shaping or getting this delivered this way or that way, that’s what just…I had to [unintelligible] I had an hour discussion with our physicist, our Gamma Knife people, our neurosurgery, and they all had a slightly different take on it, but the standard thing is the way this thing is getting, evolving, delivering the energy is [noise-inaudible] changing and how we plan this to get there, but the actual delivery mechanism itself isn’t changing much.
Ms. Sonia Chambers: Can I ask a…I want to switch gears for just a minute and anybody who needs to leave, please go ahead. This has been very interesting. Thank you for indulging us. You had no idea you were going to get to do a lecture today, but it was very informational.
Mr. Dayle Stepp: We ought to have a guest lecturer at least once a month.
Ms. Sonia Chambers: There you go. We should.
Mr. Dayle Stepp: On each specialty that we’re supposed to regulate.
Ms. Sonia Chambers: There you go.
Dr. Lewis Whaley: I will be happy to speak to the facts. I’m not an economist, sure, but I know the basic issues and I know human nature. I know when I see a patient that struggles to get in a CB from McDowell County or from Webster Springs or whatever that worries about the cost of gas, they worry about paying for their treatments, and I know that the system we have in place is working. If something would change dramatically that’s when I become concerned that it may not work if those, we the people who fall through the cracks.
Ms. Sonia Chambers: I had one slightly different question and Gary or anybody else, please, when we get to looking, re-looking at the standards I’m sure that there are other clinicians who might have slightly different opinions than Dr. Whaley does about…not that he’s not always right, but they might have slightly different opinions about the efficacy of a Gamma Knife or a CyberKnife or why one needs them and we will certainly want to hear all of those. One other thing occurred to me as we’re sitting here, which is we’ve talked about surgeons being part of this equation, we’ve talked about radiation therapists being part of this equation, obviously the radiologists have some skin in this game or you wouldn’t be here, so can you explain to me, and I’m guessing that this might be different from institution to institution, as to who actually participates in the various types of care for patients?
Mr. [??] [??]: Well let me clarify. Our organization does have diagnostic and interventional radiologists. We also have radiation oncologists and medical physicists, so…
Ms. Sonia Chambers: Oh okay, all right.
Mr. [??] [??]: Now if they can get [unintelligible]. His doctors are at St. Francis or St. Mary’s and his doctors have an alliance, but he’s not going to go out on a limb in either direction, which I admire. That’s fine.
Ms. Sonia Chambers: But you have radiation oncologists and physicists and dosimetrists?
Mr. [??] [??]: No, the dosimetrists are actually the hospital employees.
Ms. Sonia Chambers: But you have those, as well? Okay, I didn’t understand that. Okay, that explains it a little better, but I’m still guessing that there might be some issues since that all of a sudden, particularly, I would guess in brain issues, because with the CyberKnives, at least for St. Mary’s, it was a joint venture between the neurosurgeons and the facility as opposed to the radiation oncologists and the facility.
Dr. Lewis Whaley: Well see, there’s a little pearl that I was unaware of.
Ms. Sonia Chambers: Right? That was the case, right?
Mr. [??] [??]: Yeah, it’s a joint venture.
Dr. Lewis Whaley: You’ve never heard me come up here and say look, we want a CyberKnife or we want a Gamma Knife.
Ms. Sonia Chambers: I’m just curious. This is just my curiosity about, because I know particularly…I know in other areas of practice there are differences from facility to facility in terms of who is credentialed to do different kinds of services.
Ms. [??] [??]: So it’s a scope of practice question.
Ms. Sonia Chambers: It’s kind of a scope of practice question.
Dr. Lewis Whaley: Well the radiation oncologist is the physician component. He is ultimately responsible for evaluating the patient, determining what the problem is, what type of radiation needs to be applied, and how much radiation will be delivered, he writes the prescription just like [snaps fingers]. You show up at your doctor with a sore throat, he gives you a prescription of penicillin, the radiation doctor writes a prescription for a set amount of radiation. The physicist, who should be board certified and if he’s not board certified he should at least have a senior board certified physicist on staff providing services, the physicist’s job is [unintelligible]. He is there to maintain the quality of the machine, to make sure what’s coming out of the machine is adequate, and that the machine doing what it’s supposed to do. He is also an integral part of helping to plan the dose and how the dose is going to be delivered. Directly under the physicist we have the dosimetrist. The dosimetrist is usually a radiation therapy technologist that has gone on for special training for a year or two and has taken an exam called a Certified Medical Dosimetry Exam, to show their expertise. Their job is to sit down initially with that patient, after the physician has outlined to determine what the area is that needs to be focused on, they sit down and try to create radiation beam arrangements that will minimize the damage to normal tissue as part of that treatment delivery. The physicist is ultimately responsible for what the dosimetrist does and he checks their work to make sure. Now sometimes they get stumped, they get a particular problem that’s a little more difficult and the physicist may have a broader background as far as just training in physics that will enable him to make suggestions that will work better.
Ms. Sonia Chambers: I understand that type of arrangement. My question relates more to the M.D. to M.D. The neurosurgeon, because Gary up at Morgantown, who operates…who actually operates the Gamma Knife or not operates it, but makes decisions about the course of radiation?
Mr. Gary Murdoch: In a media fashion, a physicist, a neurosurgeon, and a radiation oncologist are all physically there today as that dose is administered to that patient.
Ms. Sonia Chambers: So it is a collegial relationship between the neurosurgeon…
Mr. Gary Murdoch: [crosstalk] better than others
Ms. Sonia Chambers: And Dr. Fukishima is a neurosurgeon or a radiation oncologist?
Mr. Gary Murdoch: The fact that Fukishima is a neurosurgeon has nothing to do with the Gamma Knife. When Fukishima brings the patient in, he’ll say often times there is… he doesn’t [noise-inaudible] but he says I can’t get it all, this needs Gamma Knife, go to Dr. Carlton [unintelligible] Gamma Knife that’s four or five hundred a year and so…
Ms. Sonia Chambers: Dr. Carlton is the radiation…
Mr. Gary Murdoch: No, he’s the neurosurgeon.
Ms. Sonia Chambers: Neurosurgeon, as well.
Mr. Gary Murdoch: And then the physicist and the radiation oncologist. What I have seen when we did this, there is the way a neurosurgeon would say a Gamma Knife should be used, the way a radiation oncologist would say it should be used and the way a physicist would say it should be used is sometimes a little different and that’s why we’re trying to get some…sometimes a lot different.
Dr. Lewis Whaley: Tell her what Federal law says.
Mr. Gary Murdoch: What, the radiation…that’s why…
Dr. Lewis Whaley: The radiation oncologist has the final say. He is ultimately responsible.
Ms. Sonia Chambers: So we take the Huntington example where the CyberKnife is a joint venture between St. Mary’s and the neurosurgeon, not the radiation oncologist, correct, as I recall?
Mr. Dayle Stepp: Right, it was the neurosurgeons.
Mr. [??] [??]: Truth be told, late in the game the two radiation oncologists got involved in that acquisition, as well.
Ms. Sonia Chambers: Okay, so it’s all of them.
Ms. [??] [??]: How collegial.
Mr. [??] [??]: But what we discovered at the eleventh hour when we did our Gamma Knife was that…well, we definitely would have Dr. Carlson, but the European model will have a difference in what the Federal law here versus the Federal law…a neurosurgeon and a physicist in an appropriate licensed organization in Europe do this without a radiation oncologist for Gamma Knife, but that’s not the case in the United States and at that point we had, at the eleventh hour, realized wait, we need three people and then you get into three professional groups and you get what about this, what about…and it’s a gigantic pain in the whatever, but that’s…and whether 1 or 15 or 20% benefit from the differentiation of Gamma Knife to the CyberKnife, but…if you want to be educated, I don’t know if that addresses your question, but that anecdote probably helped addressed it.
Ms. Sonia Chambers: Yes, leave it to me to open up a can of worms.
Ms. [??] [??]: So you would say it would be fair to say that a neurosurgeon cannot direct a radiology/oncology program in isolation of a radiological oncologist?
Mr. [??] [??]: Well, I think I agree, yes.
Ms. [??] [??]: You can’t do it without one of Dr. Whaley’s people…
Mr. [??] [??]: Right and you a rad/on can’t do it without a certified, or should be, a certified physicist. There is a…and again, do that without somebody making sure radiation’s…
Dr. Lewis Whaley: They can do it without a certified physicist, but they should not be able to. There’s no way they should be doing that.
Mr. [??] [??]: Yeah, actually I thought that was right, I thought we had to have a…well you are right, because you got to have a physicist somewhere in the mix, whether it’s part-time or full-time that’s available, but there is a collegial team effort and how well you get along is a really important aspect.
Dr. Lewis Whaley: Well this has been educational for me.
Ms. Sonia Chambers: Aren’t you glad you came today????
Dr. Lewis Whaley: Suddenly I realize why the CyberKnife people are roaming all about town behind our back trying to…
Ms. Sonia Chambers: They want the neurosurgeons, all three of them you’ve got.
Mr. [??] [??]: They’re going after the prostate, actually.
Dr. Lewis Whaley: They’re trying to sell…they want to sell a machine.
Ms. [??] [??]: Well let me ask you a question with regard to the prostate. Is the prostate like endoscopy and colonoscopy, is it a moneymaker relative to other radiological procedures?
Mr. [??] [??]: Well it’s a disease state that’s growing and there is a market…this is a mercenary…[crosstalk]
Dr. Lewis Whaley: It’s bad [unintelligible] cover the things that need to be treated that don’t pay.
Mr. [??] [??]: Twenty to forty percent growth in this market just due to the aging demographics. I mean prostate and brain tumors, to some degree, and how this gets treated, they’re still…who knows in five or tens years, but that’s why there’s so much emphasis on it…
Ms. [??] [??]: And is it more common now to treat prostate cancer with radiological therapy than had been happening in the past because you can direct the mechanism more carefully?
Dr. Lewis Whaley: Your chances of being cured of prostate cancer are the same whether you have surgery or whether you get radiation, okay? Now there are different types of radiation. There’s the type where you put little radioactive seeds in the prostate gland, there’s the type where you use external beam radiation that we’ve been essentially talking about. There are advantages to both of those two types of radiation modalities, but for all intents and purposes your chances of being cured are the same.
Ms. [??] [??]: In the past, men would choose not to have any procedure at all because of the side effects and the quality of life issues.
Dr. Lewis Whaley: Well people typically wanted to be treated, but the side effect profile is probably 5 to 10% of what it was say seven or eight years ago.
Ms. [??] [??]: Okay, I get it, that was my question.
Mr. [??] [??]: If you look, I know exactly where to go. You go to Ohio State because they have an aggressive surgical group. They do 400…they do a bunch of stuff that you go somewhere else, that procedure percent use rate is radically different. There is no standard, if that’s what…I think that’s what you’re looking at, but the way we look at it…we’re trying to figure it out, too, and we get into planning and I talk to discipline A then I talk to surgeon B, I’m getting…even in our own internal place I get two significantly, interestingly different physicians at times, again according to the education. I’m not taking a position, so…
Ms. Sonia Chambers: Well, we’re about out of time.
Mr. Ed Hamilton: I have a question and this is more a general question as it relates to Certificate of Needs standards first and then oversight second. We’ve got the MRT standard. If we change it to an MRT SRS standard and then go from there, where does, particularly where we say we need to have this mix of professionals and quality standards involved in the CON standard, I see that as being the initial hurdle. What about ongoing oversight. Two years from now is anybody going to go in and look at a program and say you’re up to snuff, you’re not up to snuff? Things go on from here, is the Department of Health charged with doing that? Is it the Health Care Authority that’s supposed to do that? Where do we go after the initial hurdle?
Ms. [??] [??]: Related to that, is there a JCA specialty in radiation oncology? A special accreditation process?
Mr. [??] [??]: Well there are special things they look at. They have a section in their manual.
Ms. [??] [??]: So part of the Certificate of Need could be a requirement that you be accredited by JCH? Would that…
Mr. ]??] [??]: JCH only applies to hospitals, but if still we have the contract with the hospital they should be in sync…they shouldn’t be too far out of bounds from that.
Mr. [??] [??]: Could there be another standard such as…
Ms. [??] [??]: Yeah, that’s what I was…
Dr. Lewis Whaley: Oh absolutely. The American College of Radiation Oncology, the American Board of Physicists, [unintelligible] all have standards. The American Association of Physicists in Medicine, AAPM, have standards published that are well accepted and documented as these are of the minimum standards that we feel are necessary in order to provide quality care.
Ms. Sonia Chambers: Do you have a credentialing or a crediting designation from those bodies for your facility?
Dr. Lewis Whaley: We do. Our facility is accredited by the…we’ve had an inspection not just the JCH, but from the American College of Radiation Oncology. They’ve come through and credentialed our department.
Mr. Ed Hamilton: If you lose your credentialing what happens?
Dr. Lewis Whaley: You know, I don’t know the answer to that.
Ms. [??] [??]: Would Medicare require you be deemed accredited by somebody in particular?
Dr. Lewis Whaley: Not at this point, but personally I don’t have a problem with it. I think it’s probably a good idea ultimately.
Ms. Sonia Chambers: And the short answer to your question is well, the Health Care Authority can condition a Certificate of Need for three years and the Health Care Authority has not traditionally taken the position that they are going to go out and inspect, show up, surprise, and take a look at things. We have recently been looking at some issues like cardiac cath labs to see if they are meeting their numbers as they say they are going to, but other than that, we have not traditionally done that.
Ms. [??] [??]: Ed, just a thought. For third party payers, don’t you all require that they either are InterQual or what’s the other one?
Mr. Ed Hamilton: Well there’s a variety of different credentialing guidelines that apply to particular specialties, but…
Ms. [??] [??]: So you’re going to be participating with all these facilities, so wouldn’t you require that they be approved by InterQual or one of the other agencies?
Mr. Ed Hamilton: A lot of the credentialing guidelines apply to individuals and not…particularly if a group of individuals gets together under the shelter of an LLC or something and decides to go into business and do this particular thing, so there’s some gaps there, quite frankly. I think the Feds have a better model for enforcement than anybody else and that’s probably because that that’s the realm I’m most immediately out of before moving to this one and they have particular standards and they reserve the right to go in on a periodic basis, or a regular basis or whatever they feel, and check to see if standards are up to snuff, so you’ve got your initial hurdle that you clear, but you’ve also got the inevitable enforcement that of somebody from OIG looking over your shoulder, so therein lies the question on a state basis if we set a guideline to say you have to do this, this, this, this, and this to qualify, what comes after that, because I’m used to seeing that and saying okay, what do we have to do to stay in line?
Ms. Raymona Kinneberg: There are different…I think there’s one or two different kind of, I don’t know whether it’s credentialing or…but I know UHC and St. Mary’s both have designations under, qualifying as a cancer…I think that St. Mary’s is educational and UHC is comprehensive and you probably have the WVU that is somewhat and I think that there are…I can send you some information.
Ms. Sonia Chambers: There are lots of accreditations.
Ms. Raymona Kinneberg: Yeah, there are lots of…yeah.
Mr. [??] [??]: If you’re not accredited, you just go out and create your own board and accredit yourself.
Ms. [??] [??]: Get it on the Internet.
Ms. Sonia Chambers: Well we’re running past the time. I appreciate everybody’s time, interest, and attention. It was an informational session today. I appreciate that. All right, if you’d like to submit written comments we’d love to have them within 30 days and otherwise we appreciate it. Thank you.
END OF AUDIO.