and christopher kelly here on behalf of did many made us and we're here today because secretary of health and human services as some policies and practices that are inconsistent with federal laws and regulations that the secretary would li three to ignore these things in defer to the secretary's interpretation alternatively secretary would like for you to not consider some point because some of the matters have limits to judicial review for some points in some of the statutes however where the secretary's interpretation is clearly inconsistent with federal regulations and under the circumstances this case where the challenges we bring are not within the scope of the limits to judicial review the issues are properly raised properly before this court for consideration and the first thing i'd like to point the court's attention to you is the physician's certification stat says that a physician's order can be obtained by physician by a nurse by discharge plan and also says that that doesn't have to be done it's time to transport you can get this certification one thing that is troubling to me about that argument if you two things are actually personal if you look at the statute that how we present aside the regulations the statute still requires medical necessity for the want and don't delegate set to the secretary but it seems to me a big stretch to say that the secretary can delegate medical the medical necessity determination to a physician sixty days out from a transport and that to me seems contrary to the statute that any physician without any supervision no kind working behind it is absolutely contrary to the statute so we're not even in the deference here but when the regulation should have been enacted you're right and so is that the problem is that it is it's contrary to the statute i don't see how you can rely on it i don't think it's contrary i think i'd say it's well i think it it supplements and certainly it puts the your argument is that if any physicians have sixty days out certifies that's it you can't go behind it i think that's what look at the the history of the notification it was clear in the you know brags that what's in them publications that this was not to be in a delegation of decision no forty two physicians that that what it always was subject to oversight as to whether that that was legitimate medical necessity determination so i don't see how you can say you you just look at the letter of the record not the history certainly not the statute i think part of the history is interesting to the secretary points to a lot of sections in the federal register but most of those deals section d three with the problems about getting a physician certification statement in these non repetitive transport's where you don't really have an attending physician but that there is a section at sixty four federal a thirty six forty one that says if the ability to safely transport the beneficiary given the beneficiaries condition is at issue then the supplier may obtain from the physician the necessary documentation supporting the reason for the transport so i think the secretary has always intended to relegate this duty to that there can be a hearing or some sort of oversight sums were never side they've never said that you could delegate to physician who espouse already without any kind of oversight that the statute does not contemplate that in any set of circumstances i think the to second guess the medical judgment of the physician is problematic to say the least i can't see how an e m t could could do that again and i liken it to taking your prescription that your doctor gives you  the pharmacist looking at him and i don't think he looked at sic to me i'm going to fill this that's what we're asking these e m t used to do if we require them to get a physician certification statement and then also require them to ignore it by not transporting the patient which is fundamentally unfair the secretary has set up this system and i think the secretary should be stuck with having to deal with the ramifications i think it's an fundamentally unfair to contractor may not use extract collection unless the secretary determines that a there's a house right of air or b that documented educational intervention has failed cure their section b s never been an issue in this case the issue in this case is a whether or not there is a high rate of air that's sufficient to justify extrapolated damages no that section goes on to say that there should be no review of determinations made by the secretary of sustain for higher rates of air now in this case there was a determination made that the initial error rate they only reviewed forty claims out of a universe of over twelve thousand had that error rate on those initial claims review was considered hot and therefore they extrapolated damages across the universe of the whole twelve thousand claims we don't challenge that we cannot we don't challenge the use of extrapolation in that case we can't because they jump through the  may use extract relation when they make that final however during the appeals process at every step claims are found to be payable so the error rate was changed the secretary does not argue that any new error rate was was actually noted or that the new error rate was found to be considered still high however the secretary still allowed their contractor to extrapolate the damages that is clearly inappropriate up and remembering it seemed to me that they took the that whatever the right remaining is not hot did you were you able it might be made we made that argument but they never rule and they didn't say yes it's higher no they they said that again there shall be no administrative or judicial review determinations by about the secretary did were you able to argue that the methodology was flawed when she took the fourteen out of the forty sample or did you when we made that argument especially in regard to the cla outside the time to reopen we said that those statistical sampling said you have to pull forty planes and you pulled seven of them that you shouldn't have ever had the authority to reopen so now we've got a smaller sample and now it's not statistically valid but again they they aware of but also the secretary has said that a rate of error for one type of her glider isn't necessarily the same comparable to another type that's one of the reasons that never set hard lines you know seventy five percent fifty percent  twenty four percent low they've never done that because they say well you can't necessarily compare the rates for a service to a heart surgeon to a d m a provider what may be a high rate of error from one specialty can't be considered after another so mix that the resulting error right is not high as a matter of law in other words you have authority from apartment started proceedings courts anywhere else that that there resulting right does not come within the high year all i have is the statute that says they mean that the secretary must make that determination and here the secretary admits that they didn't is there any authority that addresses those resulting right without them you know there's not and the secretary and his is probably rightfully refused to publish something along those lines in again because there's no judicial review of that specific fact of whether or not an air raid is hot we can't really get to any case law on that point but what we can create case law what we can get to is the fact that no determination was made at all that's the important point for example if if it had dropped to ten percent and they still said it was high if they made that determination and said yes that we still think that's hot but i disagree with that wholeheartedly i think that would be unsupported to challenge that could i come here and say you know help me out ten percent is not hot i can't do that because the regs says akeelah not challenge a determination made by the secretary of a high or sustained error it but again what i'm challenging here is that the secretary fail to make that determination is a in that is an exception is not the general rule not after the medicare modernization act the the him in maine made extrapolation an exception the secretary has to jump through hoops in order to qualify they have to show that they that they may use a triple h because they may not unless there's that threshold finding and the record is silent on that threshold line because it doesn't exist the secretary admits that no  considering on the constitutional issue or the district court should have let us have bring those issues up for the first time because the administrative process is not appropriate for addressing constitutional issues let me ask you about your after the beneficiaries that exists exactly the point the been of the appellate is entitle to receive money from the beneficiaries for any claim that medicare denies the beneficiary is still responsible however when  use extrapolation again there was forty claims actually looked at herself for twelve thousand beneficiaries in this in the universe we can get the money from those forty but the other ones there are unidentified how can we get money from sixty percent of the universe we can't sing you a bill and say hey we think that you may be in this sixty percent so you know it's a money it's impossible and for that reason we do have a vested interest that the due process is completely d please the court for the secretary i'd like to begin with the colloquy that counsel had with judge owen about whether the secretary intended to delegate the medical necessity determination to doctor sixty days in advance of coverage and the secretary it certainly did not intend to do that that's not the way it positions sort of occasions generally work within medicare is the appeals counsel noted and that's certainly not what the secretary intended with the israeli actions as the secretary explained each circumstances the secretary quote added close quote the requirement of physicians sort of occasions to ensure that non emergency medical coverage was still medically necessary but when a physician certifies up to sixty days in advance that a service might be medically after the as a practical matter how does that work i understand your honor and so i think first of all it's important to note that these are not nothing and we're not talking about the emergency cases so when something happens in an acute is there the same manager comes week after week a routine basis and so i think a great example of this is on page fifty two of the record one of the claims the secretary denied is a claim or someone had a physician certification and for diabetes and people a diabetic patients have good days and bad days know if you don't have an answer you don't have an air raid siren i don't i don't have an answer to that question as a general matter i do think that not all of not every single one of the claims they were overturned were to two claims that had a physician certification i think some of them may have fallen into the  of medical necessity review and so as a general matter it will shouldn't be that unusual for medicare to audit on the back end and make a determination that in fact some of those claims were medically necessary and we did pay you for them but it's time we now realize that that was  us it's time to recover the money that's the deal of the of medicare general operations in this area so i don't think there is surely have to be a kind of fraud situation for that to for them to make sense but i do think it's important to know that this is this is the way medicare is structured that these physicians sort of occasions are not binding on the secretary it's also the way that the secretary has explained the physician should have occasional parliament that the secretary is always retain the right to review  to review the physician medical necessity terminations and the facts on the ground and i doubt i do last night your honor that to the extent that these practical problems exist that undoubtedly exist today because since the events in this case the secretary has expressed the revised the regulations to place the burden of ultimately on that ambulance company to ensure the fact that the services are medically necessary the regulations have been revised expressly stated that physicians should have occasions are not binding on the secretary and that the secretary has the right to  determine that they were not medically necessary so these practical problems that opposing counsel and dominion is pointing out about how the system can't work the way the government is describing it is in fact the way the system is working today and the way the system works in other areas another example of this your honor and the medicare peals counsel pointed out is for in patient hospital services covered under medicare part a for inpatient hospital services physicians make determinations that a service is medically required but medicare none less retains the right to review and insure that service is medically necessary before actually making it billable that simply as in most cases the way for physicians certifications work your honor the court has no further questions we asked th court affirmed the decision of the trial had a lot of oh ok ok let's say hypothetically that added the four forty samples that they looked at it wasn't fourteen or sixteen did that thirty not happen they decided were covered so you're now down to is not the kind of question that the secretary could review in administrative proceedings or that this court should just review i think in a case like that the mathematics would work out in a somewhat different way where there extrapolation i would be it's quite low and possibly work ridgeley their rights determined to be ninety five but after going through the administrative appeals process it's down to like two percent or three percent so it's clearly not high value anybody that i know of definition isn't the provider in talisay there is no you can no longer use extrapolation because although there was a determination it under one set of facts that it was high and it's now conceded the air right is one percent less the secretary's willing to say one person is high i don't see how you couldn't say that it shouldn't there be some sort of other assertion or finding by the secretary that the new right is high you know i you know i could imagine arguments being made in the fields process like that that the extrapolation is inappropriate or doesn't well like that but hypothetical what do what does a court do with that i don't think a court we have to accept it's gone from ninety five to one percent and we have to accept that that's a high rate of beer i suppose certainly that's not this case your honor but i'm not an asshole you just said well the secretary's finding is clearly no longer valid that the way congress set up the structure of this program is that the high elation was improper i don't think so your honor because the regulation the statute says that the higher rate determination isn't subject to administrative or dish or abuse so congress is trying the at that point simply review of the sample and then can't the administrative process say extrapolation is not appropriate in these circumstances is it you know i don't i think as the extrapolation is still valid side mathematically valid i think that i'm not sure that the secretary would would wears a statute say that you cannot review the application of extrapolat that congress is cleaved off from the rest of the dish review and administrative review processes so the reason the secretary couldn't pass on the question of whether there was a higher rate in the sample is because the question was placed before the frontline contractor in the because the mathematical formula requires the secretary to take a conservative estimation such that the likely amount of overpayment is there's a ninety percent likelihood that the true amount of overpayment is greater than the amount that the secretary is taking so in a case like that where there's one percent overpayment extrapolate across the twelve thousand claims and then a conservative estimate is taking yes the secretary would be intitled i think it's titled in that kind of case to take take that piece of it but that doesn't amount to nearly the kind of situation that we're in here this is a case where even after of trying to get ahead the legal piece yes and i understand your honor i don't think that the reason that someone that that's your right that that is a logical consequence of our position but i certainly have never seen a case in the course of working on this case where that those that kind of radical material change in the amount of air in the sample rate has been presented to the secretary has occurred in the course of the administrat so it's a little bit of uncharted territory here the closest case i've seen is gentiva the d c circuit case where in the course of administrator view i think the error rate dropped from eighty something percent to twenty percent and the d c circuit said in that case that it couldn't review whether or not i mean this is this particular challenge wasn't raised to be clear on or whether or not the sector had to make a new finding of error but the sec but the desert did say it couldn't review that the error rate i'm just trying to understand how this works yes of delegated to the the pick the integrity contractor the determination of whether or not there's a higher rate in the sample and then the administrative review as it was here is focused on whether or not the claims in the sample were medically challenge in this case the methodology simming that the error rate dropped to sixty five percent their body gree to the yes yes is there any challenge that's an invalid extrapolation other than the legal arguments that seven claim the sample population i think the claim i think this is in the mail day decision that their claim was that the sample needed to be pulled from different parts of the universe acclaims instead of just one random sample taken but that is the kind of claim that also is frequently brought in these kinds of proceedings but they haven't pressed any challenge like that before you their challenges before you are simply that the secretary couldn't use ixtapa lation in this case the secretary had to accept the medical necessity determinations of physicians there  series of challenges that amount to the argument that the secretary shouldn't have authority to look at their claims not to challenge to the way the sick to actually determine that they were medically necessary and the conduct of the extrapolation all of that is in line with the  the propriety of books regulation the application of particular case to the extent there's an organ by somebody like minion that that is a due process violation that's not something that a ministry of agency is going guess let me step back i think that it is wholly within the secretary's ability to say that it is dominion is correct that there needs to be more certainty for example in the in the way extrapolation is being performed in order to ensure that their due process rights are protected and so the sample size should be larger or the precision rate in the ultimate outcome should be greater those are the kinds of applications of the general principle of extrapolation in light of the process that the secretary sho better example is their challenge to whether or not whether or not beneficial or not they have a right to go after beneficiaries which we think is a is an unresolved question that the agency should have the opportunity to pass on in the first instance by application of its various policies that is that is very much in line with the heart of what the supreme court discussed in illinois council about how there isn't a distinction between constitutional and non constitutional challenges to agents in a huge government program like medicare the agency should have a right to apply its policies to a given situation and consider whatever the constitutional questions are before a court takes a first pass on it and maybe does something that is difficult to square with the way the system as a whole is operating so that applies to the entire appeals system in really any six pack that sean says pacifically sampling does not deprive due process that's our challenge so to say that the ruling doesn't apply to the specific challenge we make is nonsensical clearly that precludes meaningful review in the ministry process because they've already made the decision which is binding on everyone in the image started process that  sampling does not deprive due process now the specific argument that we make i don't think there's any case law on it he says that to be nice for the secretary to consider it well that that real issue is providers and suppliers have a right to go after beneficiaries for deny claims there's very limited circumstances where they don't those circumstances don't apply here again there's no allegation that they do the ambulance service has literally tens of thousands of claims that have been denied in this extrapolated universe they have no idea which patient they belong to there's no way to go after those individual patients that's  process challenge we make there's nothing in the ministry process that's going to change that there's nothing in the ministry or process that's going to be able to address it again that this ruling precludes it so i think it was clearly before the district court appropriately clearly i think the secretary misunderstands the substantial interest we have we're talking about that over a million dollars of claims that have been requested to be repaid that we have no idea  i'm pretty sure that the questions i appreciate the secretary's candor in saying look we believe that the initial determination that there's a higher rate supports the use for extrapolation throughout the process but that's not not was higher months ago maybe in some other probe or a view that has nothing to do with even this the cases that issue it makes no sense and we don't have to delve into the the actual error rates all they have to do is look problem is and it's this is my that's my area of practice i do primarily administrative health care law and i think it's a fundamental problem that the secretaries basically told all their contractors look you don't have to mess with it you just do that initial threshold finding understand where it is that is from a court standpoint if the government is taking a position which they appear to have done in your brief that sixty five percent is a high rate of error and that  i don't i don't think rick will me and all the way back to the to the administrative process as appropriate i think the secretary had the obligation and the opportunity to make that funny about the use of extrapolation at that time in failed to do so i don't see anything that would make remanding all the way back to the secretary at the beginning of the ministry not also at least where we were right all i'm saying is that we say ok there's a problem because the secretary didn't make a finding that sixty five percent is a high rated near you we reverse in remain to somebody eventually you get back in the administrative process and the secretary says we stand by the we stand by the sixty for the same thing that we did sixty five percent is high