Reimbursement Issues in Clinical Trials

M. D. Anderson Cancer Center
Date: 1/31/2008
Duration: 0 / 47:58

Ron Walters, MD, MS, MBA, VP, Medical Operations and Informatics

Ron Walters:

I have number of roles of M. D. Anderson, one of them, I think that's pertinent today is on the Medical Director for Managed Care Programs which is a job that I've always liked doing. It's fun wrestling with all of these different payers and we know we're doing it for all the right reasons. I wish I could say exactly where we want to be but we're still probably a few years away from that. There is progress being made and I think the world, a few years from now probably would be a little different than an even is right now. So here is kinda what I set up as n agenda, one is talk develop. The problem is the terminology related to that Medicare's standards and coverage policies, private payers, how informed consenters into the process, some state legislative initiatives that are going on, federal legislative initiatives, patient advocacy initiatives and then what community to help with all that. So if anybody wants to talk about anything else we can, I can certainly ad lib without most things but I thought this might be a little bit relevant to the group. So here is basically what I called a problem statement and how on earth are we supposed to conduct high quality clinical research and complete important clinical studies, complete meaning to finish 'em without placing the patient at financial risk and within the guidelines of good informed consent so what I try to cover in that statement was kind of the interests of the parties involved; certainly one of them is the patient that's why they come to us, that's why they seek our advice and they want to achieve hopefully the best outcome as possible and many times that does relate to participating in a clinical trial. The research, of course, we have our own particular motivations for making this happen. Of course, we wanna do the most good for our patients certainly tie him to our academic careers in the futures. Certainly, impacts our ability to get arrangements with various sponsors and so on. Compliance office enters into the picture and we'll show how they come up in just a little bit but we have to do this in a way that certainly does not violate the code of federal regulations. There are very few things that will shut you down quicker than that and to make sure that the research that is done is done in a way that meets the guidelines of the law. Pharma, of course, and I purposely; these are ranked actually in some intended order. Pharma is those nice people sometimes end up contributing in all for a lot of money to contribute to drug studies and finding out different pieces of information. Obviously, their motivation eventually and one form another is to have a marketable product that they can then recruit a lot of there money from. Pharma has been very much our friends and our enemies in this process all along. We've had certainly shared motivations and shared good goals and then sometimes we have to be aware of the extent to which those goals conflict. And then payers who still ranked below Pharma on the on the list and the payers are still caught in the mode of trying to cause you up as much as they can. They know that this is a political windmill that's accumulating strength that they probably not gonna get away with it for too much longer but certainly digging their hills and as long as they can because that's I learned the term a long time ago in the insurance world, the medical loss ratio. You have to realize that that's exactly how they think of it. Payers are more than happy to take the premiums that we pay them as covered beneficiaries but if they have to pay any money out that's called a medical loss and many ACEO, COO, CFO and medical CMO, medical director has been fired because their medical loss ratio has gotten too high. We would consider that a reinvestment back into the patient but that's our unique perspective. The payers, obviously, are something we all have to wrestle with then we'll talk about them in just a little bit. So another problem is, and I've been involved in this for 29 years now, we still kinda trapped in the way we were trained. There's some classical terms which we know the meaning of, but the outside world sometimes uses those terms against us in this context and those again are classically the phase 1, 2, and 3 type terminology. We all know kinda what those terms mean but putting the wrong hands, they can be interpreted in ways like or phase 1 means non-beneficial. Phase 1 means you're only doing pharmacology studies and of not therapeutic intent. Well Dr. Chris Rock's institution has published that will change about seven or eight years ago. Actually, given certain diseases and certain stages, the response rate to phase 1 trial, many times exceeds the response rate to more standard FDA-approved agents. Phase 1 can mean a true non-therapeutic in tip pharmacology study but the number of those trials that we have and certainly that this group has to deal with is not very large. Most of the time as physicians, we advise treatment to patients because we believe it's going to help them. Also, phase 1 over the years has formed the high breed of take a few standard commercially-available agents throw in something you're trying to determine the toxicity of the so called combined modality treatments or combined type treatments especially with things like targeted therapies and all of the sudden you can see you're really not talking about the classical phase 1 world anymore either the response rate to many of those programs certainly is expected to be no less than the response rate to maybe the standard agents administered individually. But, another group of terms that these ears on the other end of the phones just love to catch us on are the investigation, experimental, clinical trial, clinical research study and even protocol. There are some payers that if you even use the term protocol to, it's click buzz and we know that protocol can mean just a tracking mechanism of keeping track of how we do with different stage and treatment of patients on very standard agents but protocol is another one of those words patients don't understand what the protocol is. Many of the payers still don't understand what quite protocol means. Certainly, investigation or experimental, those again are probably terms that we should be very, very careful about how we use those in our conversations with the people that we deal with. We know internally, we have to and so in all of our consent forms, what have been like the third or fourth term after the title in it self as a problem. The third or fourth term in the next paragraph has always been an issue for us. What do you call it? Is it investigational? Is it experimental? Do we go ahead and put phase 1, 2, and 3 and there rest to that. So who actually has at the most right? Well, believe it or not it's actually Medicare. Medicare is our friends in this regard. Medicare in 2000, of course, President Clinton issued his executive memorandum directing the secretary of HHS to explicitly authorize medicare payment for routine patient care cost and cost to the medical complications associated with participation in clinical trials and so they did that with a national coverage decision issued on September 19th, 2000. We don't have problems with medicare patients anymore. Now, I realize that doesn't necessarily apply to where we have different problems. Sometimes the reimbursement isn't too hot but we don't have any problems getting them on clinical trials as long as they meet certain criteria but the criteria are those that really are not to its owners. So this is actually, over the years, one of our best friends and this is actually kind of the model we would like to have for our dealings with all of the other payers. So the routine costs of a clinical trial again are, first of all, there has to be an anticipation of benefit to the patient. That's good again, because we are usually quite clear about what we are doing for pure early stage, really true pharmacology studies versus those that have therapeutic intent. We have to, of course, be treating something that's not statutorily excluded. So, if I wanted to do a clinical trial of, say a given type of plastic surgery for a certain condition, plastic surgery would necessarily qualify in the clinical trial and NICD wouldn't protect us on that situation. We know that what is not covered of course is the investigational item or service. That doesn't matter. That's usually provided for us by the sponsor. That's exactly what all of these is about. Certainly, the data collection piece which is why we have to build all the cost analysis into our studies to make sure that those are appropriately covered by the sponsor and then any other items in service is provided by the sponsors free of charge for [unintelligible]. Medicare just doesn't want you double dipping or profiting from all of these which is the purpose of the whole NCD and so the routine class included in the clinical trial of the service that are typically provided absent in clinical trial which again is what really does us the most benefit in those combined modality type treatments. I understand services required solely for the provision of the investigational item so again the chemotherapy administration charges and et cetera et cetera and then most importantly, items are services needed for the reasonable and necessary care arising form the provision of investigational item or service like the treatment of complications and the bottom bullet is a huge fighting grounds still with the managed care companies and that's one of the ones that we need to make continued progress on. It is absolutely silly that if we would admit a person for say neutropenic fever or thrombocytopenia or whatever particular, say a tumor lysis syndrome as part of their standard care just because that occurs as resolved of the clinical trial all of the sudden it's click buzzing, were not covering it. But that doesn't make any sense, whatsoever, and yet only Medicare was able to recognize that. So again, number 1, here again is the three requirements is it has to fall within the Medicare benefit category and be not statutorily excluded. It cannot be just when they say designed exclusively to test toxicity again, that's the very early phase 1 stuff; it must have therapeutic intent and I really wanna stress that wording there because when we get to talking about our dealings with managed care companies and payers, we need to make sure we stress to them that we are giving this for therapeutic intent that it's expected to benefit the patient. We may not know the exact magnitude of that benefit but this is not "totally experimental investigation" all those other terms. And of course, we don't yet have Medicare providing coverage for healthy volunteer trials. They have to have a "real disease". So these are also some desirable characteristics and obviously, again, from a pure scientific experimentation point of view, that purpose of the trial should be to try to figure out whether the treatment improves the patient's health outcomes and usually we have no problems about that. There has to be adequate available scientific and medical information to justify the trial. This one is, it shouldn't be unduly duplicative of preexisting studies. It should be appropriately designed to answer the research question and then the sponsorship has to be true from a credible organization; again, certainly NCI and that's where the category fits into that and I think those are very reasonable criteria to have as reasonable expectations. Now, we almost got in trouble last year because that policy was brought for review, that NCD and there was a lot of nationwide comments that went on about it and for a while there it looked like the NCD might undergo significant redoing perhaps in a negative way and a way that would threaten our further ability to conduct clinical trials. So in July, CMS began that reconsideration and sent it out for a national comment. Fortunately, the comments in our input and many other institution's input where such that in October CMS closed the reconsideration and the policy as it was written was retained so we're still good in the Medicare world. Now, private players. Unfortunately, they are still for the most part way behind Medicare guidelines and continue to deny coverage for any cost associated with the clinical trial especially earlier phases and usually for any complications suffered from patient in a clinical trial. I just met with our melanoma service this morning. We discussed this very issue. Last year in the breast service that I worked on, we noticed a 76 percent decrease in registrations on our adjuvant and neoadjuvant study and guess what, that study is five commercially available FDA-approved drugs with treatment of breast cancer not a drug experimental in them. But, because there are some things that were going on the payer world and because of some processes internal M. D. Anderson, we would use one of those words like study, clinical trial, investigational result and it would be a prompt quick buzz. That doesn't do anybody any good. We've got some performance improvement projects going on internally to try to get a standardized way that we talk to payers about clinical trials, Dr. Chris Rock's group, ironically Dr. Chris Rock's group, was the phase 1 area has a very high success rate at giving clinical trial coverage and you would think that that is exactly who should have one of the highest success rates but the reason they do it is because they have scripted what they say. We cannot lie to the payers, that one comes back to haunt us. We cannot provide them any false information and they're getting smarter about the information they asked for but the scripting has to be such that we stress the therapeutic intent, the published data and what they wanna hear mostly is what bills might we get stuck with. And so to the extent those are the same those who get stuck with if you didn't approve this clinical trial to the extent we can show them we put a lot of thought into it that conversation sometimes goes a little better than it goes other times. The other thing I've learned over the years, it's one of my recommendations later on, direct medical to medical review is a key part of that process. Remember, payers have processes in place to take a paper-based authorization form or a call from say someone in the business center and say no. I think they thought that the first day of training to say no. They're counting on you not calling him back. They're counting on the doctor not wanting to speak to the medical director and say, "Can I discuss this with you"? There are some payers still and we still run into were after a lot of times spent like business centers and there's a lot of time spent by our doctors talking to the medical director, they are still turned down. I can't say it that that does not occur but it is certainly much easier to get something improved if there is that positional interaction. Because again, if we portray where rationale is and are sympathetic to their concerns but somehow we've taking care of them that's really what their primary concern is. Now a reason why when you'll get one to say something like still well I can't make that determination because it's a benefit's thing. Our purchaser has decided they're not going to cover for that. That's nonsense. They have a lot of latitude in the decisions that they make and the purchaser you can better bet doesn't go through line item by line item. We will cover this trial, we will not cover this trial, we'll cover this trial, we're not gonna cover this trial. So when they use that story on you, that's usually again they're trying to get you to say, "Okay, how you feel that way I won't bug anymore" but that's exactly the point to say, "Now who can I talk to"? Now the other thing that works very good on this is remember that each of us has an employer and employers come in a various sizes. So to the extent that it's a small employer, you might have troubles. But to the extent, and we have this happen about 18 months ago, a lady with Continental Airlines really wanted to take part in the clinical trial, got the usual click browse from an unnamed insurance company. Boy, she went straight to her VP, benefits and HR and it took him up three to four days but they eventually said, "Yup we agree it's in your best interest, that's why we sent you to M. D. Anderson". So sometimes, it's just a matter of different pass we have to go to. Sometimes it's learning how to express the issue but this is a battle that we can win and need to continue to win. So I said, "It's hurry up"!

Audience Member:

[Inaudible] to have a designated sort of snake charmers plus bulldog to have some conversation and has had the...

Ron Walters:

Yeah.

Audience Member:

Win the battle or we have Dr. X say this is my patient then I'm gonna try it TP goal and make that a...

Ron Walters:

Who is this snake charmer, an MD or a businessman?

Audience Member:

I come in their office. The patients are snake charmers but if people like you do really understand them and everyone is into this versus asking the primary physician to go ahead and make this...

Ron Walters:

Yeah. It's usually about a good idea too maybe because I'm not a count tip expert in each disease that occurs. I'm a low level expert to each disease but when they get down to saying something like what's been the response rate with standard agents or what's been the response rate with 2 out of the 3 and why do you wanna add this 3rd one to it and so on. That's where the true expertise can come in and quite frankly our docs can smell 'em. I mean they can explain exactly the rationale of the trial, what they're trying to accomplish and at that point, the poor doc on the other end who's got about a 100 other things to do just said, "Oh okay, you know, I'll tell my UM department or you have to build it". So I'm in full agreement, again, there is no replacement for the direct PI preferably to medical director conversation but I also know they don't want that to be the first step. They don't want all the calls coming through the medical director. They want them routed through the proper mechanism. Why do they want them out routed through the proper mechanism? Because they want to make sure that the reading out occurs that the people that won't challenge them on that, they get denied and nobody pushes it anymore. If they know everybody picks up the phone and calls the medical director without going through the UM process first, they're gonna eventually lose. So again, Rosella [phonetic] has actual experience about this; heavily dependent on the words we use when we call. Try not to use experimental investigation. Try to even get around phase 1, 2, 3. Those are just about losing words. We are doing these things for therapeutic and tip. Here's the rationale, here's what's proving, here is what we're trying to prove and by the way here's what the sponsor and that's a more honest and I think a more effective strategy heavily dependent upon position involvement. Again, I've heard from some of our services who refused to call and some of them are very involved and generally speaking, the more involved the physicians are the better the success rate is. Heavily dependent on the size and influence of the employer or purchaser so that's usually my ace in the whole then that I go to after the doctor talked to the medical director as it worked then will say, "All right, who you work for" and if they say you know Halley Burton, you now continental you know or something our eyes just light up and would say okay let's live with a call into your benefits and Human Resource Department and see what they can do because again a lot of times these payers do not want to jeopardize their relationships with their very large purchasers. This is very much a tricky world of, yes they don't want the cost going up but they don't want these fast five members who are at M. D. Anderson sitting in the clinic waiting to get approval for a clinical trial. The payers hold the power of retrospective review which is always true so all of our pre-search say something like we've all seen them. This is not a guarantee of payment, we all review the charges later on so you just have to take that in face value. Actually the number of retrospective denials is not that high. We don't see it. We seem to think the bigger problem is the front-end stuff not the back-end stuff and I really don't have one favorite payer yet. I just was at MCCM yesterday and Vilma Gibme [phonetic] said they had lot discussions with United about a lot of things. United has been in the news about small things lately but one of the things they're trying to push is to get clinical trials at an NCCN Institution to be perceived much more favorably by a payer like United. Just not quite there yet. All right here is what I call the collision with informed consent that causes us all a great deal of problem. For most of my career here this was about paragraph 8 and then it slowly has made its way down to about paragraph 17 of what now is about usually a third year 40-page document. Basically it says if you skimmed down there just a little bit, my insurance provider or I maybe financially responsible for the cause of supportive care and treatment of any complications resolving from standard medical care that I received. One of these research studies will be built to my insurance provider and or mainly in ordinary manner. I should learn before taking part of the study which parts of the research-related care will be provided without charge which cause my insurance provider will pay for and which cause will be my responsibility. Now I called this the ambulatory surgery center class and unfortunately, we've not operated like an ambulatory surgery center for many, many, many years. There's not one of us who goes in to an outpatient surgery center that we don't know before they do anything what our insurance is gonna cover. How much we're expected to pay for and what the risk is involved with that and how much we might have to end up paying. In the days of rich oil here, we didn't wrestle with those sorts of issue starting about until 5 or 6 years ago this is causing a great deal of problem and it's probably the number 1 source of tension between the researchers and the business centers. How much do we tell them? How much do we scare them? If you got a disease like acute leukemia where we say your counts are 120,000 you gotta come in the emergency room, you gotta come in tonight. We gotta start treatment tonight or you might be dead tomorrow but there might be a little bite of about a 200,000 dollar risk associated with that. I mean that's a very uncomfortable situation to put the patient in under those sorts of circumstances and yet we can get into serious trouble with the code of federal regulations if we don't do that. And so somewhere in there is the balance point. Somewhere in there is the statements light. Well believe it's a very likely this is gonna be covered, we will be your advocate, we will fight for that, we will appeal if we need to but like anything we cannot guarantee you that things will be covered or won't be covered. We can't give you that guarantee because they can always review it on the back end anyway. I have a lot to talks about with Carrie King Lions about this and what she won't let us do which really is hard to do and she won't let us make statements like there's a 3o percent chance that your insurance company won't pay it because in actual fact we don't really have that solid of data. We have feelings from talking to the insurance company. We have retrospective denial data but none of that's hard enough to really back like in a court of law where you said it was only 30 percent and it really looks 50 percent or something like that. The concept is still there. The patient like all of us would want to, in many other situations in life, we would like to know what our exposure might be and the best we could do is to give any estimate with that, the best we can be. So whereas continuing to work on this, how I am working with the business centers on this is we're trying to move into what I recall a protocol classification type system which I've arbitrarily called green, yellow and red and the red are the ones that are very high risk and we're certain are gonna post problems. We have to call about those. The green ones are kinda like the one I alluded to earlier where gee it was 5 standard drugs all approved for the treatment of breast cancer. The odds and it sure is gonna come back retrospective, deny anything for that are extremely low from a clients' perspective and yet it was us calling asking mother may I that led to a dramatic reduction in registrations on the protocol and affected our ability to do research in the breast section. Then there is that big yellow group in the middle and the yellow group we kinda talked about might be something that was kinda high-breed of different therapies or where its out-patient treatment maybe the drugs sponsored. There's a relatively low chance that person whatever have to come into the hospital but it's not completely zero and from an institutional perspective we might be willing to take that chance. That's still an evolution on meeting with all the departments to classify their protocols under that course of the system so that I can try to relieve this tension, really it is between some business centers we have and some of the MDs involved in different departments. But you know that's what the code says and that's what our informed consent says that we have to do. Well as you know well one of the states just come along and mandate that everything can be covered, well the blue ones are other ones that have any sort of law whatsoever. The laws vary; some are must, some are should, they have different clauses attached to 'em. You'll see the big gap in these. One of the gaps is Texas. We've not have any sort of state legislation that mandates the routine cause of care. Of course why is it state governed? Because it's the State Department of Insurance that regulates insurance plans. Well now there is, after working with a couple of different legislatures for a couple of years now and presenting different data like that behind and what the different states have their policies, we got a Senate bill number 674 proposed. Don't quite know what's gonna happen to it yet but it's the coverage for the routine patient care cost for always participating in certain clinical trials and you can see that it's written basically to model the Medicare NCD. So we're hoping that this goes through. We're very confident it's to, certainly it's gonna run into some push back from the managed care companies but at least we have a bill in the House or in the Senate actually to be enacted upon and hopefully that will get done within the next session or two. But, the problem here is at least in our institution about half of all the non-Medicare patients that we see who wanted to take part clinical trials are self insured. By the way, we are all employees on the self-insured institution. If you or I wanted to take part in a clinical trial our administrative insure is Blue Cross Blue Shield of Texas but we fall under ERISA because we are self insured. This sort of legislation, state legislation cannot override Federal ERISA laws. So changing ERISA which is a very broad-spending piece of legislation, one of the things at which is covered in there is health insurance coverage and retirement plans. That requires going to the Federal level and having them looked at ERISA. Now if I had to guess how long that was going to take that's not a one year or two-year deal because ERISA is very wide-sweeping legislation. That's what we would have to do, for example regardless of what the state does, if we as M. D. Anderson employees wanted to have the right to take part of a clinical trial, ERISA would have to change. Well, stay tuned to that because actually next week or the week after I've heard that a certain well-known Senator of the East Coast of the United States may well propose some sort of legislation at the Federal level to help us with the coverage of clinical trials outside the Medicare so that will maybe changing. Well who probably is one of the best people to go to and again these patient advocacy groups? The ultimate power I think still does reside with the patients, hopefully and preferably, if there are patients and employees of rather large employer groups but that's where the real power is. That's what employers don't like to here from. That's what member services department and the out plans don't like to hear from and that's what congressman don't like to hear from. So there are hundreds of advocacy groups. The last one was pretty successful about lobbying against changes in the clinical trial policy, changes that were proposed. They're usually very disease-specific. They're sometimes organized around more general purposes but that's where it really boils down to and that's gonna be the ultimately effective tool. Well what can you do? Finally, one certainly be an advocate for your patient. By all means, if you're asked to talk to a payer take the time to do it. It's probably the single most important thing to do. Direct medical review usually does work. A doctor on the other end does not like being in the uncomfortable position of saying no to a doctor on this end; some of them will do it, some of them will hide behind like I said the statement well it's not my authority to do that. I can't do it. The purchaser is only the one who can do that, so on. Someone of them will do that but more often than not, if you present a cogent, valid argument for why you wanna propose this particular clinical trial, they'll listen and if not, one of the most powerful advocates again is the employees HR benefits office especially if they're self funded. I think we are slowly winning the battle. This has been a very slow battle, though and I think, both on a state-wide perspective and on a Federal perspective, you are gonna see some changes in these as time goes on to make this a lot easier for everybody involved and certainly a lot easier for our patients. Remember the more we give you a note, their job is to drag it out as long as possible and we have to just show them we have as much patients as they do when you call back, when you call back, when you call back, when you call back. So any question at that after all? Yes!

Audience Member:

Is there a difference that you came for the proposed randomized than working on non-randomized trial?

Ron Walters:

You know randomized to give, I think is that you know, I haven't seen that difference. I think it's because it's the clinical trial part of the phrase that the antennae already goes up about. The randomized, non-randomized piece is important from a scientific perspective but really not as big from a payer perspective or from the medical directors or so on. Now if you wanted to use that sort of an argument, when the doctor was having the direct medical review, that be the kind...well standard therapy has done this but we're doing this to see if it really makes a difference and by the way the incremental thing is being provided by the sponsor and so on. That's the kind of way I would use that. Anything else? Yes, hi!

Audience Member:

Especially NCI-sponsored trials, does that have especial magic?

Ron Walters:

Gives you the Medicare world easier but yeah it's one of the criteria for Medicare coverage of a clinical trial but at this point in time, not in the payer world. Now I alluded too, you may start to see some changes and unite its policy that reflect exactly that, that if it is closer to the Medicare wording, if it's an NCI-sponsored trial, it's okay we'll let it go through. I think there still gonna probably exclude some things like some early pharmacology study though.

Audience Member:

It's not Medicare though. As you say, NCI you start at the other phrase that go with there, phrases that kill you.

Ron Walters:

I guess the other phrases. I think I've always been in the impression that if it's not so much whether or not NCI is in there, it's the other words that follow that I think. This my is my opinion but...Yes!

Audience Member:

Optimum procedures were in the protocol it states that this may not be received too at all by your participation but they have two on them [inaudible] that if you can count on any problems medically or whatever the thing that you brought up. Whether they give complications, I'll say a procedure is optional?

Ron Walters:

Well those are usually blood drawn in biopsies though and so fortunately in the payer world, what they see on the back in is just a CPT code for a given procedure like a biopsy that almost always is gonna covered if it's a blood draw, that's one of the things that is usually written into the protocol anyway. So sponsored, non-sponsored comes into play there and then what exactly the procedure is but they can't tell on breast biopsy really being done to establish diagnosis from being done for the clinical trial. Now, we obviously have reasons internally why we need to properly allocate those costs to the study if they're only being done for research purposes.

Audience Member:

Usually you have some blog that came out about some modifiers and are now supposed to be used in q 0 and q 1?

Ron Walters:

Yeah.

Audience Member:

When billers put that down in their coding things.

Ron Walters:

Yeah.

Audience Member:

How will they suppose to?

Ron Walters:

I didn't actually see what happens there, that's right. I know. I don't have any data yet to tell whether that negatively impacts our reimbursement on the back end, obviously you can see the wheels turning that LG we see this codes, click buzz again, kicks out of the system and so on goes to medical review. We'll just have to see. I mean that's kind of like the G-codes that came along a couple of years ago as far as their trying to get now stage specific, indication specific, information above and beyond, ICD-9 and CPT codes and potentially using that and quality improvement program of course against us. I suspect there's a hidden agenda behind that but we haven't seen a negative impact yet. Good! Yeah.

Audience Member:

[Inaudible] with their vitals and the same things like we agree that if your insurance doesn't cover it, let us know because there is quality covered for that which.

Ron Walters:

Yeah.

Audience Member:

Went rounds with their I or B because they don't feel that that something that really should. Now if there is an insurance company that denies something do you take that step further if your promissory is already saying that is already covered and it's a denial?

Ron Walters:

Yeah! So usually in my experience has been when they put statements like that into the trial or into the protocol agreement, it usually means like on in outpatient basis or for the few days of therapy administration or defying time period, you don't see that many right now that have and we'll cover infertility everything that happens down the road due to complications of care or some treatment related side effects. So I think what those do is those cause us a certain amount of trouble internally ascribing cost-allocation to this different things. That's really what are really problem is. Our financial system is to be able to handle a proper cost allocation but I think I would push them in what do you really mean, you know because that's a very broad statement and if again if you think of the leukemia patient or something, that could mean, now BMTs are a whole different world but two or three months later at 200,000 dollar bill or you really mean in that the insurance doesn't cover that, you're gonna pick up 200,000 or 300,000? I can guarantee if that just about erodes there are reasons for doing the study right away. So now I'm a little skeptical of words like that. I think again Racelle's world might be a possible world for something like that and meaning like if it's a three-day administration of the intravenous chemotherapy in the hospital and you're insurance doesn't cover it might, right, I mean, yeah. Because the next thing they don't like is our room rates and we have pretty steep charges that we incur that they usually mean like yeah but like300,000 dollars a day total in cost indeed, that's not even our opening the doors you know.

Audience Member:

An institution, a large company about the payments, they seem that part of the new resolution of how much they will pay on clinical trial?

Ron Walters:

Yeah. So it's like anything else. We've gotten it successfully written into two managed care contracts when they came up for renewal. Those two managed care contracts were very small contracts and they really wanted their patients to come here so we said, "Okay, how much do you really want it because on of the things we wanna put in the contract is you allow us to do clinical trials on your patients and we won't give any sort of you and I hustle about it. They said okay. We have not won that world with the [unintelligible] as the Blue Crosses, Uniteds, et cetera, et cetera, et cetera. We are sure tryin' but it's elephants pushing elephants at that point and they say, "No way. We're not gonna ride there, you know. Every contract comes up for renewal although we do asked about that and so it's on our points of give and take right somewhere along physician rates, room charges, you know, drug charges and by the way clinical trials you know. They really do historically they hide behind. Well, we can't agree to that because we don't know if our purchasers will pay for that you know. I've been really impressed at what I call the impotence of the medical director sometimes when they want to be. They have the authority to do overrides on a lot of things but when they want to, they can hide behind things and say, "Will the purchaser really has the ultimate say about that" you know and you know that's not true, you know that they do have the authority to make decisions like that but they just choose not to do it. The plans do the same way. They say, "Well, you know, the purchaser didn't wanna purchase our product that allowed for clinical trial participation? Well how do you know? I mean when the patient's come here we're here on the other hand they do so it's still a very confrontational world. It is. And we know what they're about. They're about as high of a medical loss ratio as possible. Hey other questions? Yeah.

[Inaudible]

Ron Walters:

That's fine. I consider them one of the biggest content experts are also usually that's nurse to nurse staff because the reviewer that the insurance company is gonna usually a nurse and so a research nurse and some of our research nurses build up pretty successful relationships with reviewing nurses and insurance companies and that's been a successful strategy. I think, in general though, it's not to hit the medical review level that anything really happens? I haven't heard of a lot of successful stories of less than medical review being successful intermittently. Tell me about their needs? Make you mad? We're working on it, I think there are gonna lose this battle eventually whether it's legislatively, politically, costumer service or contractually or all of them. I think it's a battle we're going to win but you just have to get keep after it. Meet your needs? Well thanks a lot.

[Applause]