clearly written policy surance coverage for state employees in this every health health care to state employees but the primary agency during that period of time was the part time children and family services and health care in two thousand and six the defendant the state defense c m s which made the primary contractor also happily and this involves what is sometimes referred to as the health link  y they are the venue in the state of missouri and although they deny having written the summary  plan descriptions that are talked about very often in briefs and also in the record i think it was best explain choke when this case was filed circuit court we were trying to put together a record after the decision that was made by yes we were only allowed not to present evidence but it's met under the statute the illinois statute to peer review articles written prior to that time we had no opportunity to present every evidence one of the important things i think to the court should be that we did not because of the condition of the client and because of his protection that appeared to be in the summary provisions that we were provided they said quite clearly that what they would do is what they were told to do by the non state defendants who were acting he said ministry program so it was important to us to either get a final decision here or to get a definitive decision where we were allowed the and other words things went into this record after the decisions were made after both decisions there wasn't even a solicitation of an expert witness until after the september seventeenth decision in two thousand and eight so our whole thrust at that time was to get to sign off the time and sets we believe that we had been not den the opportunity for a hearing and since we believe this to be contested case our release that we sought based upon the cases that are cited and are preferred is that those proceedings were anality the they should not be remanded but they should be told to comply with their own recommendation of their consulting physician  the problem that the court is confronted with now and that we were confronted with three or more years ago was that the s statute health wing did not it minister a plan that we do about or that any state employee that opted for their plan could understand because it was not in this record and it was not in their hands in the period between two thousand and six and two thousand and eight was a huge gaping change as far as what was going on with respect to coverage for state employees eight we were not given an opportunity although we requested for it for hearing repeatedly and repeatedly tried to expedite this matter so we would not dated on or before the date of the original hearing which was september seventeenth two thousand and eight we did that and what the trial court decided w well in their words really did recommend now there is a difference in these peer reviewed medi their purpose is to initiate a dialogue with creating an apology so they understand what's happening in these ongoing clinical tr this all happened a couple of years down the road we were sent back to the same place from whence we had come we did what we were asked to submit at those journals th considered the first time around when we came back the decision that the trial short judge reached was that these did not really recommend expensive treatment and the judge comments upon and the result that he had which is you quibbling to what was being reported in these medical and his finding was i'm not allowed to take that into consideration i guess what we're saying with respect to these the doctor is required to make that pay so the recommendation doesn't go to the court it doesn't go to the providers it goes to the treating physicians who are dealing with the cost and i think the record reflects that he did benefit i was never administered to him subsequently over the next two years he died two years later none of these pharmaceuticals are magic pills that guarantee a result many of them just extend life maybe a half a year maybe two years maybe three years residence th wasn't medically necessary because its investigation investigational is not a term that is found in the because these health care issues are not moved simply because this patient god is widow was substituted there are still things that need to be cleaned up as far as doctors and what we're asking that the trial court where it's whether the illinois employees group insurance it ministration are required to provide notice and due process hearings or deny determine narrow legal issues and statutory interpretation contract exclusion none of this is required none of this is c m s and required  witness report and put it in the record and you don't have an opportunity either cross examine a present any evidence on the other side it's a foregone conclusion they pre determined that this would not keep you that's why the doctor went back to them and said look this is necessary medical care for this patient we want an expe either under section four of the group insurance act which sets forth the standards under which such coverage must be provided or under the medical benefits plan that was obtained from the health link  it ministry or among various selections for state employees that has a specific solution that will vote for experimental investigative procedures well i think we understand the process of how those decisions for such a long period of time i think the c m s procedure i just want to clarify went by quickly there was an initial processing back and forth at the administrator stage which is subject to appeal  i think part of the the the misunderstanding here is that the plaintiffs treated this issue as being one of a medical necessity determination and in essence it was an administrative determination contract interpretations are not subject to an expedited review procedure the medical necessity ones are subject to an exploiter seizure but this wasn't you know essence a medical necessity cision  you know it's perhaps a truism that something that is experimental work best a good if cannot be also deemed medically necessary but the two are to a certain extent distinct even though the category of experimental procedures creates a curve out for medical necessity and i don't think anybody is unsympathetic to that to the human circumstances here but the characterization i believe in the pla completely that chronology but there was prompt response the difficulty here is not so much that there was a disagreement it was about the diagnosis malignant  four cancer that nobody disputed that that was the case health link it provided coverage when there was the first diagnosis of melanoma the operation the subsequent procedures then went after the remission when the cancer returned there was a n coverage provided for all the standard recognize protocols in the medical field for the treatment of that unfortunately those treatments don't have a great track record prolonging life much less a is missed one in during the disease and when the the ones that have been proved to be effective under established medical research standards have run their course  the planers doctor dr lynette was at the time running a clinical trial for this very regular avastin with these two other chemotherapy agents had run out of options and said now and i think this is important clarified because players it shown a clear response but that's well short of establishing the standard of fact yes that both the statute and the plan make a condition for treatment to be covered we live in a is a universe of treatment that is practiced and is generally accepted practice by a college just consists of off label three you know let me just briefly defined it case a member of work doesn't understand it that's a drug that's been approved or a treatment approved by the f d a for some disease or condition but it doctor is liberty legally to prescribe it for another condition for which it hasn't been quite yet safe and effective doctors do this on a regular basis so just because it's not f d a approved for certain conditions doesn't mean they're just average but the flip side is also true just because a doctor prescribes an off label treatment doesn't mean that it is and really we're in this this middle zone where i think section six point four to be sure a sack has established a set of standards that are clear that can be articulated and can be applied and leads you know to the side much of  about whether a particular prescription of an off label drug will be covered and there are three ways to satisfy section six point four either it is a view in which case it's got or it's one of the listed treatments on their the treatment that he was describing and then finally the legislature is sad but even if you don't meet either of those standards you can still get coverage and it has to be provided under one of the state plans if it has been recommended  clinical studies the results of which have been published in peer reviewed medical journals in this country or in great britain and i understand that the word recommended isn't perhaps the term that these studies use their medical research they're not legislators recommend i think it's fairly understood to mean that the that the results of the studies show that the treatment is effective for what it was intended to do it's better than a placebo it's at least as good as the alternative treatments that means you  survival extension life extension those are the standards that are used in the study to determine whether a particular treatment is a factor and that was the that was the that was the what we were looking for here was any stu that was peer reviewed of a formal clinical study that showed that that was the case but you weren't allowed to consider studies that were done after the theory or after a certain point in time well the decision was made the decision was made based upon if there was a study a month ago why why should we consider it today you know i suppose that's a good question but it sort of that was presented at the time decision was made and i want to i want to you know sort of tread on this issue very delicately c m s is job is not to predict the future of medical research their job is not to say we predict that future research will show that this friedman is a fact they have to make a decision on whether the risk coverage or not based on the standard and it's not whether they predict that the treatment will be effective it's whether the established research shows that it is  not just showed the pricing by simple mary studies and the plaintiffs disregarded that limitation they added all sorts of post decisions settees and i will point out that it's significant that they omitted to include dr lynette's own study that he was wearing at the same time that the plaintiff put that get into i assume it's because that study was closed they had more than two hundred patients in a randomized double blind control placebo walk under versus the actual treatment system and that study which they didn't submit position of saying well we'll submit post decision information that favors us although it still didn't get them over the hurdle but what will exclude information that shows the opposite of what we're trying to prove ok can we consider the fact the medicine that offended  patient in this case i don't think that's been established by the record i think the doctor showed clear response but there's no indication that the medicine prolonged his survival showed a progression free  doctor did say that he had seen that there appears to be no new nose during this that i guess two week period or three week period when they were ministering to disease but but a single person with anecdotal evidence of that  prolong your life under the scientific standards that apply to this type of medical treatment otherwise we would be in the situation where contrary to the public policy prescribe by the legislature that medical benefits plans are paying for status treatments as part of their coverage they're paying to fund research for all sorts of things that aren't established and i think that's sort of heart breaking wind for a lot of people to accept but it's one of the alternately the tax payers and their legislators acting through their responsive agencies have said that that is what the state's responsibility gives them let me let me take a somewhat absurd example we all laugh about doctors prescrib shows that it's effective for that type of treatment that's what we have here we have a doctor saying this is the best option but there are no good options the heartbreaking for a visit there are no good options for malignant melanoma it is one of the least treatable forms of cancer and we can't change that the court can change and if the decision was made based upon the record that was submitted that the standards under section six point four to publish you know peer reviewed clinical studies showing that it's a fact that wasn't mad and the provision of the plan which they have discretion to you know to to make determinations on her it's it's an experimental treatment but then it's their responsibility to apply those provisions and say that there was no such thing and the fact that back the one that at the same time was doing this regimen in a clinical study that he was conducting that is in the record that tends to establish that it was experimental as opposed to being confirmed to be proven safe and effective and i do want to respond to the comment there was no opportunity to submit evidence to c m s m s as soon as the appeal was taken to c m s c m s said the administrative review is the exclusive remedy was inappropriate we responded february of last year so i think many of the same cases including embassy know in the us those case which explained very clearly that it ministry of there is no right to a pre determination open exclusion under the plan this is a page thirty eight of the record in order to seek an appeal but that they were denied clay the first time there was the night claim that was submitted t of this program they were to apply eleanore law they merely have an obligation to make a recommendation to the state of illinois and if you take the time later to look at what that initial denial said was that we were denying this because we were told to  this was indeed the administrator there was no one to my knowledge c m s who have the knowledge of children and family services health care and with a help and assistance of the attorney general  they made the decision and they're responsible for the way we pleaded with him over and over again to put this in the lamp or in the lap of the ultimate decider they did not saying we're conducting an investigation here we'll let you know later and then we get a stylised or rubber stamp signature we got four of those during the period of time we were asking for  in this but we were given summary plant descriptions to go to your doctor that we provided he will do everything for you don't you won't even have to do anything sell well what happened is the doctor understood what this program and he understood he was entitled to an expedited appeal if he was representing a client that program thought that they were going to receive with respect to the contract exclusion they're relying on in one term this isn't an experiment language throughout that five city here is investigation and that's found only in their medical policy and other words their internal acting as an term they used it was investigation that's not in the s p d so we were given it's not in the record the term that used in the exclusion is investigate and that's why we get into the whole at any level this was a pre determination that they were not going to pay for this expensive drug to anybody however it's not only been approved as a cancer drug it's approved for eleven other