thank you good morning and may it please the court i'm pleased to be with you this morning in this unusual or mats we're here today your honour's because the decision below leaves my client with no determination so that the device would be covered by medicare and other insurance i got the st two and it made every effort to pursue the rd including formally request day in and cd as it is entitled to do but the agency said without even being willing to start the proper process a single official simply announced that the device would not be covered now our brief points out a number of problems with the district court's decision and we stand by them all but i'd like to focus my time today on the issue that seems to most dramatically separate parties before this court which is the question whether sensory had any avenue available to it or here at the end the administrative agency or under section four hundred and five g through waiver of the exhaustion requirement the government points to two possible avenues for review the problem is the those avenues are both available only to beneficiaries and not to manufacturers like sensory and either one of them could provide the relief that sensory needs which is a positive national coverage determination good case that this you say that this device should have a national coverage determination that you know should be covered for large numbers of people but there isn't one person who's been willing to bring your coverage use it as a manufacturer in order to even produce and distribute this device they needed a national coverage determination or else d it's not able to get funding and access to the systems of distribution that distribute medical devices  to have a manufacturer whether they can do that in advance of actually being prescribed the treatment i'm not sure but but yes that this right for review can be assigned but that the issue of court review remains the individual benefits determines this avenue for review could not produce a national coverage determination if the results of that review would only be that that particular person is entitled to coverage and as the  courts as both the district of d c explained in the baxter case and the district of event it explained in no doubt it would be entirely impractical for a supplier like sensory to expect to have to litigate individual presents an entire job ca of information and it is exactly what the regulations provide it should initiate the process of a formal national coverage determination instead of following its own process with the agency did is is simply issue a letter saying we're not going to do this it's not common it didn't follow the regulations that are also set forth in the excerpts of record beginning at excerpt of record eighteen or seventeen which provide the process that is supposed to ensue once a manufacturer provides a formal request for a national coverage determination so it was a formal process process i understand that but we took what kind of records we have about this actually works on an individual so that we can understand difference between exactly what this device is exactly how it works and provides all the kinds of information that the agency requires in order to consider and national coverage determination and under the regulations what the agency should and in fact there were several different steps that sensory went through it asked for a billing the billing purpose denied it sought an informal benefit category determination that would have been the informal process but the official found that the device didn't qualify as durable medical equipment then get applying it formally for a national coverage determination which is this submission i was referring to but the same official issued a letter saying how it's not covered and the secretary concedes that that was a formal request for a national average determination that the bridge on page nineteen and then because sensory would still frustrated it actually pursued an additional meeting with the deputy director of the centers and heard nothing for six months and ultimately filed this lawsuit it was only the filing of this lawsuit that yielded finally a response to that informal meeting which was a letter saying no we're not be considering it's not copper so there was nothing informal about this there was a different process the agency should have followed but it can't of the fact that it didn't follow that process doesn't make that doesn't make this an informal result in fact under the regulations it is deemed to be the fact that no process was in what's followed means that the there is a deed and national non american association of american medical colleges so that would be one way to get there another way to get there would be to follow the process that the district of nevada followed which is to actually apply for a five g the  the the regulations say that that kind of review can't be a sometimes so even if you could assign review of an individual benefits determination you can't assign review of a national coverage you know is it the a p a is it four or five years it's you know non statutory review what your actual cause of action the a p a your honor this is a lawsuit for admitted for arbitrary action or the administer procedure and but if we conclude that it's a kind of rises under the medicare statute does the bar four or five age preclude invoking the a p a never your honor because of the illinois counsel exception building counsel exception is an exception recognized by the supreme court to the channeling requirements of and it that exception applies when the the claim that the person is assert a trip attempting to assert under the a p a hasn't the opportunity for review at all at the agency it had to do with reimbursement of recoveries it the crib said because this attorney is not a medicare beneficiary he did not have the opportunity to present his challenge to the same administrative chair channel as the beneficiar so there's no review at all available to sensory so does that mean that i'm that there's a denial on the grounds that this is not a medical treatment that it's a final decision under the a p a and it goes to court snakeoil or no no no no but why but there needs to be a there needs to be a process which is the fundamental problem we have here is that the agency has not it has given manufacturers the ability to seek international coverage germination but it has not provided manufacturers with any ability to see it in a straight of a view within the agency so if there is an arbitrary denial of a national coverage determination then there has to be some opportunity for review of that and we get there through the illinois council exception the agency could solve this problem by creating an administrative avenue for review that is available to suppliers but a supplier cannot challenge the denial of a national coverage determination and a supplier can't even take assignments of the beneficiaries realty to challenge the national coverage determination and even if that if a better fishery challenges a national of its nial of a national coverage determination the results of that review does not  a positive national coverage determination it simply means that that person's claim for benefits needs to be assessed on its own so none of these avenues your time is over yes i'm apologize or used a lot of your time or a question so i'll but that's kind of a sort of coincidence that he happens you know to be a potential user in many situations to be a company in this situation and if it is it correct that the company itself cannot invoke the two methods that you referred to yes so congress determined that in forty eight why doesn't the illinois counsel exception apply two in the supreme court case heckler versus rain or the supreme court specifically stated that congress clearly foreclose the possibility of not teaming advisory opinion from secretary herself requiring instead of a clean could be filed for her scrutiny only after the medical service for recipient is sought has been furnished in that case whether the claimants who had not yet undergone the surgery but with seeking coverage determination request and complaint in order to obtain i judicially revealed will final decision that was congress's determination that it needed a real life medicare beneficiary with an actual need for decision and in fact an illinois council it was an association of nursing homes that made the precise argument that sensory of making here that itself did not have standing to pursue the medicare and mistreated review rights were at stake and those members could get adequate opportunity to review their claims in the and minister process here this case is unique and dr burbank was the statute and regulation in the medicare statute is a routine process through which suppliers like sensory have submitted claims and the teams in ministry to beneficiaries who are in need of this device clearly there is no question among the five million and among censoring own c e o s they cannot mean assignment of a claim and your censori prayer for relief specifically requests medicare reimbursement even fashions a th amendment to profit taking claim for medicare reimbursement which it is sir it is its property to participate in the medicare program is its own choice is a voluntary it's not an entitlement if that's the risk business risk that sensory basis then it can pursue th national purpose of terminations request through an aggrieved party like it c e o but it's certainly not entitled to a specific hearing on that contention where national coverage determination and  determine a benefit category in which the device should be a national coverage determination basically mandates nationwide coverage of a device here one needs at least one medicare beneficiary in need of that device to get to the entire nation it made perfect sense for the agency not to have to go through and jump past individual censoring would be able to obtain meaningful review of the questions of whether it's durable medical equipment whether it's reasonable and necessary or whether should be fluid from tunbridge at the personal comfort  there are qualified independent contractors who are required to have scientific and medical expertise who would then provide another layer of independent review and then on top of that an administrative law judge who can bend decided her advice and the decisions could evidence conduct hearings and then beyond not the medicare appeals trial can then mine whether this was in fact should be covered or agency is not required to issue it by three opinions and the district court is also not required to that except a flood of claims from all kinds of potential claimants rd party manufacturers entities that have never submitted a claim for be embarrassment what counsel may i ask you what is your understanding of the nature of the record in this case and would you explain why it is deficient  this case essentially constitutes informal correspondence between a rd party manufacturer and the agency officials who responded to their request for a billing  censorious requests for national coverage of terminations and under the federal review register from august two thousand and thirteen that sent the agency's response to that they could not open an evaluation process for the requests also constitutes informal correspondence and advice so there's no concrete administrator record reflecting any independent findings from any of the layers of expert review that would normally constitute an administrative record for an entity seeking coverage and reimbursement them ok all right so ok pocket two minutes from his company thank you sir your honor it can't be that the power of the federal courts over a case involving the corporation turns on the personal medical condition of the cooperation c e o that would be a very bizarre result and there's another case very similar to this that's going to be argued next month i wonder whether the government is going to require the c e o of that corporation to present evidence about his personal medical condition to determine whether he could have filed and if that individual claim it is true that mr dr burbank originally filed this law suit in his own name but he was proposed say at the time and it was not dr burbank but his company that had formally requested a formal national coverage determination only to be denied so once counsel got well as as as counsel pointed out a moment ago the supreme court has held that you can't get an advance determination that's what frankly that's what the court held in in the ranger case where someone wanted to try to get to determine a particular treatment but hadn't got to and didn't have a claim for reimbursement to submit the supreme court said no you have to wait until you get the treatment what we're pursuing is a different thing we're not seeking a claim for reimbursement because the person this product is not being prescribed it's not being used there are no claims to reimburse and if there's any question about that based on our prayer for relief in the district court i can clear it up right now we are not