to reserve five minutes of time for ribot in this case the district court erred by holding that and a local coverage determination or an l c d is covered under coverage determination it is issued by a private contractor and is a determination with respect to a particular item or service that applies soley or why it is not a an that i don't think that it could be covered however the court does not need to decide that because there are other aspects of this which distinguish it from the what is covered by only one physical intermediary decision even though the services were rendered throughout the country i mean the plaintiff in this case contends that basically for them where they serve lots of different places this is sort of like the death penalty for their business but i could imagine a circumstance where it's like the only provider would it make any difference to the government in that situation no your honor because then that would just be a unique factual circumstances of that local coverage determination as we pointed out in our brief i mean if you have a test that as the buyer or provider develops somewhere else in the country even if they say there was the situation you described there could be a provider as the buyer had developed a different test that would be covered by a different where you could have another or another five provider located in a different contractors but it's all the other key point is that even what your honor is referring to would not be binding at higher levels of administrative review the contractor determination is not binding even on all if i had independent contractors would have been next level above reconsideration by the same contract regulations also make clear that all of those levels of review that the adjudicators may disregard be l c d so long as they give  same issue different results that like number one says yes and number two when it comes back on another time it's like the exact same circumstance says no is there anything in the record as to how often  different claim is there anything in the records about how often there are different results on the same issue your honor i think the fact that there's not a it's not that i don't know that there's anything in the record on that i do know that agenda b is cited in a report that discussed inconsistency is among l c d s and the need for the secretary to do war with respect to the statutory process outlined by congress which we also think supports our position that a local coverage determination i supposed to be preclearance a national coverage determinations and congress has directed the secretary to develop a plan to evaluate new level coverage determinations to determine which should be adopted nationally it also stated that the contractors themselves should consult and so there there is an understanding with the thousands over deals nationwide not just providers  beneficiaries just all the way and officially it's sinister the medicare program there is going to be some inconsistency at the outs and that may not be with respect to every service or of policy other than a national coverage determination that it would be we think that quickly supports her position as well because the l c d has the determination  secretary or the agency or the medicare program as a whole but you can have the statute itself defined as an l c d is something entirely different and also has a group least separate notice in common binding on anyone but that contractor and it's up to the individual whether or not they want to challenge ahead and in the absence of an l c d it would be just as binding on the provider or beneficiary if the contractor would still be required to determine and this court said there's an error ensure the thomson that what the contractors are doing is just interpreted in the statutory  necessary standard which is the substantive standard here it's a statutory standard which the contractors inter breeding and the l c d just allows the contractor to be more  and counsel the argument that was an argument that the government chose not to make in the case as the supreme court's opinion points out saying that the result might have been different had the government made that that argument is that correct yes i mean there are different there are different statutory standards that were at issue there was in a reasonable not you do we would win either way i mean because for all the reasons i've given so you know i've not taken a position on that in this but i think we think even if fairly major admission a bell why we contend this is too much power being given to medicare contractors this is a very significant policy and the fact that the secretary doesn't issue it triggers the delegation issue that we've identified recognize that's always an uphill battle as you're now in our cross appeal we thought if ever there's a case where a private party has too much already it's this situation and if count so if the secretary had actually actually this case and then national in scope then that would have if you are a beneficiaries in the united states if your doctor your breast cancer patient and your doctor orders these very important test to be done the only provider in the country that can provide these particular test is agenda and wherever you are in the country it will perform the test and it will be unfortunately denied coverage because of this local coverage  so i don't know how you could be and i don't know how there could be any more of a national impact than this kind of the situation so looking at the statute as it was yes that's the get i get that your honor i think when your honor looks at the coverage looks at the promulgated process for national coverage determination i think it is virtually the same or maybe a thirty day as opposed to a sixty day notice period but the national coverage determination is coming out of the government with government folks doing here and there is the in the pending process  through the process in the statute and they would have to go through the normal federal register the agency would have to do the normal federal registration see in common is that right that's what the court the court said that's get certain audience to put in gold but then they get the public input i would think the you'd have to go through the traditional room and the answer is plausible that that's what the congress intended and that no matter what the l c d s do or promulgated the only substantive legal standard governing these issues are reasonable and necessary so they couldn't possibly these l c d s couldn't possibly change it and if that's right you lose on this issue why are they wrong well your honor i think that was addressed by the court change a subset of legal standards because the statute required itself to count our patients in the medicare fraction and here the government's argument is the statute itself requires reasonable and necessary and that's the only substantive legal standards you're not whether one test that mr smith or mr yoshi mora got was reasonable or necessary well this policy that we're looking at fact much more than agendas molecular diagnostic testing this in this particular case and that point might be applicable if we were dealing with a very very important bill it was a clue that some council is your argument that some l c d s have to go through notice and comment and some don't yeah i think i think i would agree with that and in this applying to a case now but what this policy did was establish didn't change the have a new policy for all molecular diagnostic tests you can read and read more necessary or you want your honor and i don't think anybody can say one way or another whether congress dealt with that issue this is one of those classic very very broad delegation and i ask you this i'm a little confused you know with one view of this is that the standard is reasonable and necessary and this has to be changed to what unreasonable and unnecessary i don't understand what that needs i think that it could be changes in terms of how you go through the process for the death and just do a not do the agencies had to rubber stamp them but i think in this particular case though that you did not have to have reached that particular point and i've asked you i wasn't understanding i don't think from your brief that you were arguing that some l c d s needed no it is in common but not others could you explain which one is needed and which ones don't well you know i honestly cannot explain  that in this particular case the the l c d was binding on the initial determinations and that's why we made that's why we one laboratory provides these particular towns there are other kinds of breast cancer testing that are provided by other laboratories but these are unique to us and there's only one in the country that does it and process because they know all of these molecular diagnostic tests are run by different companies and they expect each company to come through this process and prove the medical necessity i don't mean this to be a flip question so it may sound that way but i don't mean it to be that way but so are you suggesting that our ruling in this case should be that this particular l c d needed notic bright line but all i know is this one which the whole molecular diagnostic testing none of it is covered until we approve it that to me is brother mouth and change and establishes a standard that in this case the court can say this one should have been promulgated as a regulation i'm not certain the contractor would even know what the administrative procedure act is you're that's one of our problems here these are not government people the is this is the medical director at the private insurance who decided the fate of all these molecular diagnostic that's why we're so troubled by the delegation and  not only put it on its website but on the medicare internet website at least forty five days before the event to date the public as a chance to comment but i would just direct your honor to that provisions about national coverage determinations which formalized in the structured way i don't see the difference between before and now maybe you can explain to me what we're talking about now i think to some extent congress was in its provisions about l c d s formalizing what w standard or only the particular item in service for that claim and these are very into it's called age of fermentation not a rule requirement or policy it's an individual determination shows that i'm sure you're not relegating form over substance here comes yes i am sure because of the fact that it would make no sense to have national coverage determinations excluded both national and local coverage of terminations that interpret the reasonable and necessary standard they do have to go through notice and comment but it's a different type of notice and common procedure that safety amendment that added the sort of less formal notice and common procedure for l c d s it sounds like you as bob might know about the history more than i do so was that happening informally already the posting on the website honor i don't know and i'm sorry i don't i mean there but i assume that before that happened there was an l c d some type of process that contractors were doing i do not know if they were doing and maybe the purpose of this was make sure it was provision so there is no need to expressly exclude l c d s then and then it was already implicit because congress in two thousand and three included the provisions about the secretary