i had a chance to mostly generally speaking to read the whole record before we come in here so if you can give us records site will appreciate it and we will also appreciate your taking note of the  time schedule on our clock a yellow light means you have two minutes left in your argument when the red light comes on please conclude on last quickly unless you're answering one of the court questions so with that i'll call the first case number sixteen five zero three nine eight max mad health care versus price miss terrell it work out of a particular hospital or you know this is standalone home health agency office address i'm not i don't have in front of me ok and they send nurses out from there i'm from i'm from san antonio so i calculate an overpayment assessed against the health care provider who or where the see a mask is to rewrite the rules of statistical mathematics or second issue is whether this record aired including the u s department of health and human services violated their own rule of thumb which is a prohibition of using screening tools for home health been a fisheries because the beneficiary must qualify for the services under t o individual lives reasons they must be homebound which isn't a natural inability to leave the home without incident without assistance they must require assistance to do that and it's a taxing effort for them to do that otherwise they could go get medical services etc see them at their home they also must require the medical services and c m s has a rule of thumb which will which of which requires that the home have been fishery be regarded only for its own his or her own situation because those two requirements make a matrix could be an amputation of thousands makes them home and it could be other order right yes plus at ten point three five percent interest i believe my heavens ok and what percentage of the patients of the company does that involve i do not know at the moment what percentage of the patients that involves i can find out for you if that is something that you would like to know well as i'm sure i'm sure this background is in the record somewhere i was just sort of trying as it is the the  beneficiaries it can be permitted for durable medical equipment suppliers it could be berated for hospitals it could be permitted for lots of other providers however c m s put in their guidelines which are their interpretation of the regulations is that you should govern them that medicare recognizes that determinations of whether home health services are reasonable and necessary must be based on an assessment of each beneficiary's individual care needs therefore the denial of service is based on numerical utilization screens which would be statistical sampling dynastic screens diagnosis or specific treatment norms is not appropriate because each been officia homebound in these medical necessities on their own basis not on anyone's comparable basis there are any cases where that provision that you just read has been held to be over and above the statistical sampling in other words there when there is a conflict or even if there is no conflict in the rule of should be used over the statistical sampling as a as a matter of priority or is it simply are you saying that it's better to have done it with the rule allowed to sample but you can't sample these folks because of the uniqueness of their qualifying for the home health services benefit and this is only about the home health service has been for their provision is in their medical i'm sorry the and so when you're talking about one hundred thirty claims a claim for each visit or a series of visits after the person is certified it will be a series of visits after this person is certified home health works on a sixty da episode right an episode can have a few visits home health food could be required for after a person leaves an institution a hospital or nursing home for training and education on n medication they must take or wound care or things like that which would be a few visits for education typically or for someone who needs more care such as a wound care patient who needs a dressing change every day in a room that they can't get tickle sampling parameters are written in the program integrity manual section eight be section three you see that references now section eight they track pretty much the same a are contained in approximately twenty two pages of program integrity manual in the sampling is just mess you take a small number say you want to know the links and weight of a thousand footballs  both are all about the same how many do you have to measure to figure out how what the link the weight will be for footballs are fairly homogenous it would take a whole lot so you may have a small sample size there for other things like fish in it a bunch of fish from the bay then wait in length of one thousand fish would be much more difficult to calculate in statistics in mans has certain formulas in programs that you follow to determine what you're looking in to see how you need to measure it measure it for the same goal and then extrapolate well let me i mean i think i followed what was written did did judge has run not even have an oral are over all hearing on this case no he cancelled  s i understood it the board with that the m a c said oh yes well dr hall are the plaintiffs a doctor which is not accurate relied too much on textbooks and treatises and under our guidelines you don't really have to do that but they didn't did their opinion which i haven't read explain how the methodology for the forced to sticks which statistics is just an estimate of the in result anyway and if you follow the proper parameters you get a reasonable miss of the accuracy of the estimate but the program integrity the academic accuracy that the techs in the tones do require in mathematics they have written a different set of requirements thus the gating the accuracy foundations for the in result now you're challenging the program integrity manual as being not accurate for the way in which the sampling was done in this case it was challenged on on the way the sampling was done in this case the initial sample that was taken did not have enough independent variables for the individual claim lines they took forty claims out of one hundred thirty and the experts the two experts the at the hearing off for the expert in the petitioners expert both said that there were flaws in this sample if you have a sample that's not representative of the universe or is in some way adversely weighted one where the other for or against the in the end result is not within the parameters required for an accuracy confidence level and that's basically what the expert said today on dr howard oliver and dr whitman now there was a there were an expert that the health integrity used i believe the underlying contractor that calculated this on statistical sampling and that expert this statistician said we follow the program integrity manual got lines and so what she emissions saying is that as long as you follow our guidelines even if we don't do it by the academic textbooks by the rules of man you can't contest the village with the limits of our extrapolation number is so they've written the rules of math to allow them to win every time and there's a due process issue with it if nothing you know about i ask you about that when was this first raised the questioning of the methodology first praised at the initial evaluation or at the a l j in initially it was raised it was raised at the two prior levels of appeal we have a request for redetermination and their requests for reconsideration and there we go to the a l j level we complained about their accuracy of their statistical extrapolation at each level we received their their documentation of how they did the statistics just before the ails a hearing thousand overcharge it's just the extrapolation in this in this case that is true so the government still has a large overpayment that they've recovered and that the the recovered they've recovered the two hundred fifty eight thousand they've also recovered the seven hundred seventy five thousand at the time to still paying the interest off and him point three five percent interest i think every seven years that doubles so he's got a ways to go to pay that however and i may have misspoken he may have paid almost all of it off i don't know how close he is to that payment i didn't calculate it before i got here do you say that the record was complete at the time the l j got the matter i did not say that the week we were able to get an expert dr wimmer to testify we did not know until we showed up at the hearing that the they tell the parties right well there are no parties this the appeal and is are the providers the only party right c m s unless they unless they announce that they are going to be a party  a participant they can give clarification or their contractors can give clarification christian issues and explain to the a l j but they don't actually have the rights of a party and if see a minister is not participate as a party we are deprived of discover there no discovery if they do participate as a party there is discovery so i take it they did not participate as a party here i've been doing this ten years they've never participated is a party in any case i've been involved misty to do the math wrong and win every time do they get to withhold the man if you want to summarize for us what are your strongest points about the an accuracy of the sampling here it would be the points of the statistical experts that testified for the end of the petitioner in that the sample was not calculated it was not the the sampling was not perform probably to give a reasonably certain accurate estimate at the end and therefore that the well let me say i think i think this i dragged i put this down from the district court's opinion he listed four things that the ail j found deficient and one of them was a failure to keep the actual random numbers so that you didn't have that data but you haven't mentioned that  argument failure to define the sample unit failure to demonstrate that the sample units were independent of each other which i personally think is pretty important and a failure to demonstrate that there was a normal distribution of average overpayment and i take it he got those from you or got those from the ale he got those from the from a decision ok that's what they all they found on the merits of the statistics is that they didn't the program integrity manual require that the estimation be replicable and you have to give us more documentation than program integrity manual tells says that you have to give it is an odd system and when that big if i may continue yes thank you when a when a contractor request review in the contract or requested that the council look at th statistical sampling issue on its own motion because they didn't project because they were the party in the the in the a l j hearing they can't make an appeal but they can request that the council look at this on their own motion when the council takes something on their own motion they are limited to a glaring error of law that had a bearing on the decision or public policy and so what they do is they  when they would otherwise if you're going to allow that the sample page to be destroyed by bad selection of numbers at the beginning by a non random sample by sample is not representative of the universe that it's representing then you say well they didn't apply a six point one you make all issues of fact an issue of law and therefore i council can review it and overturn his facts even though they wouldn't normally be able to do that without seeming as having been a pretty amazing well you have time for a bo reimbursement as a government health care provider who receive government reimbursement people are made aware that there is often a post payment review of claims that have been submitted and paid by the and the secretary of state often what triggers this post payment review is there some type of suspicion that there's an inaccuracy or overbilling correct and sophistication and this has what happened is the contractor who is hired to ensure program integrity did a c m clean of peanuts that were going out and home health care in this region and found the maps methods payments to be an outlier and what's meant by that could be many things that basically means it showed up as outside the norm or what would be expected that is within generated the review of the claims that have been submitted so they've been selected a time period about a year and a half and in that time when you say error rate is that charging for services not rendered charging for services not certified charging for services not necessary what it is not the first the services there's no allegation that the services were mended the allegation is that the services were not appropriate and should not have been that the claim should not have been paid there but as issues of home bound status the need for skilled nursing care and a combination of those two factors in this case pertaining to the nurse practitioner go to the doctor who do issued the certification i don't think that they do as a matter of course it in the record who the doctor was it would be in the medical records that are before the court so basically the nurse practitioners second guessing the doctor's orders this is a home health care payments is designed so that there would be more than simply a doctor certification a need for services but also certification a homebound thirty as opposed to five hundred or six hundred or forty but we have now close in forty of those tros and randomly out of the hundred thirty those are selected randomly yes the i don't know and actually there's no allegation in the record that there was an attempt to bias the sample of the forty that was selected i understand and the process for reviewing these is to have a nurse practitioner at the i think you said to go through and look at the file and make certain calls about even necessity or appropriate documentation or appropriate charging at what point is it decided to use this to testicle sample in other words just the forty that are randomly chosen as opposed to doing the whole one hundred thirty that doesn't sound like to me and i've never done it before i'm learning a lot about this but one hundred thirty doesn't sound like a lot more than forty i mean if you were talking about several thousand and you chose forty that might have  reason to the rhyme but i'm not quite sure i understand why we would do forty instead of one hundred thirty that's all that's about my math real quickly maybe a third thirty thirty three percent yes in this case it about a third there were actually reviewed there are cases particularly with regards to hospitals or very large providers where we would be talking about thousands or paid attention to tens of thousands of one hundred thousand of claims at issue that is not the case here and admittedly one hundred thirty claims is a sizable universe but the secretary in charge with the administration of this enormous government program has made clear determination for policy reasons that sampling and shop ablation are necessary so while it would only be one third of of one hundred thirty that could theoretically in this specific case be refuted that would be more than double the resources required more than double the time required in order to effectively go through all of those files and make a determination and in other cases it would be are really up to the secretary whether sampling is going to be used as opposed to an actual accounting well i would not say entirely in that there is a statute that says that statistical extrapolation sampling are permissible for the secretary to engage in where you have one of two conditions one is  reeducation means in this context your honor but i know that the reason in this specific sound good sounds like a warning yes you're on it ok in this case it was not be education is it issues the high outlay or status that's what generated the review and that's why i would say statutorily of the secretary was was doing more than simply harm your discretion in applying the sampling and the extra and after the thirty eight thirty nine planes were found to be paid in air and the error rate of almost ninety eight percent it's ended go to the l j who individually did go through each of the forty claims again and found a different outcome as to one so the number that we're dealing with for purposes of appeal is thirty eight claims to be well with for the sample over the whole purpose of the appeal here is not the independent from one another it within skew the extrapolation that is done so you reach a valid region ninety five percent error rate you then can properly extrapolate that to what it would be on a hundred and thirty claims but the real debate here between i think the experts and what was raised by shell or below in his expert report is how now frame up the confidence interval and how correct you are about your estimate so in this how there's actual report it is a cd which my understanding is the court has access to because it was something the district court judge reviewed but it would have to be requested page six of our public record references the fact that these c d s are with their district  mason we think is relevant is seventy four to eighty ninety two and also in in rebuttal to something that was said earlier there was a specific report issued by mason that's it five ten to five eighteen for the court  to the opinions that were provided by dr hale and so there was a rebuttal to the points that he was making but the argument in this case is not so much about where the number comes out if you were to estimate it extrapolation but it's how wide of a margin you should put on either side in your confidence in that number so in this case it's the why you have no confidence correct at some point you would have no confidence or you would get to a point where if you could not say that i one hundred thirty claims not just correct but you would get to a point where you would say ninety of those claims we know could not have been payments because we've already looked at forty and we know that thirty eight of those we are claiming are in error so that would be the point at which the margins stop because we now know that this is no longer possible but in this case what the government repayment in favor of the provider actually so i didn't i didn't read it that way but you have to explain that the ninety percent confidence and all rate is  percent likely that the true amount due would have been a higher amount so i thought the difference was something about two point five percent on an eight point five percent i think that is the margins on either side of the us event that you have should it be a two point five percent to eight point five percent but in this case where the government apply is that ninety percent confidence interval rate it airs in favor of the provider so it says that we're going to go to the outer limit on one side the provider side and then make that calculation from there and that is done to favor the provider because of the nature of these extrapolations and so my argument to this court would be  the question is whether or not the second choice final decision and that is the math decision which is the decision that is applied review is supported by substantial evidence and on this issue of extrapolation and i think the judge likely did that analysis which was to go in a very detailed fashion through the record and determine if there was substantial evidence in favor of what the second i mean with all due respect judge is a very very smart fellow but it looked to me as if he basically did what courts retain lee do in the social security cases who would say well the doctor says you know the claimant's doctor says this  secure the social security doctor says that we treat we take the social security doctor at his word and we anyway whatever whatever the a credited is substantial evidence in other words he ticked all the bases saw and he ticked off all the points but then he said well they say something here so it's stansell evidence in other words it seems sort of conclusory to me and that's why i'm asking was asking all these questions about the statistics you're right i think if you look he didn't even have an oral argument hearing right he did not he did counseling i mean that amazing i think if you look to the record and administrative record that he was revealing one can find that there is substantial evidence to support the secretary's conclusion and i would argue process so i would not know the frequency of how often they hire their independent i do know in this case we would point to the record that has evidence that refutes what dr taylor sighed as a basis to show that there is substantial evidence on the record to affirm the secretary's decision as to the extrapolation of overpayment calculation but like to touch on rule of thumb is that was an argument that was also presented today the rule of thumb argument in the government's view is misconstrued in this case the rule of thumb provision is part of a manual there's t was that are at issue here the n p i am which is the medicare program integrity immuno and the m p b m medicare benefit policy manual and so there is a huge chapter on the integrity manual that deals with  statistical sampling extrapolation which is what was done in this case and has the procedures that it's a chapter of that manual there is then this medicare plan a benefit policy manual which applies in a ride range of circumstances and max min is arguing that one provision of the policy manual should basically trump the provisions of the integrity manual the chopper of the integrity manual that would allow for a stop elation and sampling i would also argue that because as statutorily we know that there is congress has now added a statute which says that operation sampling can be done in the two instances i discussed before that of high outlier or statutory authority for doing that in this case what was done on the forty files that was reviewed individual was not a rule of thumb analysis at all or rule of thumb analysis would say every time i see claims for injection of insulin i'm going to say that those were improper what was done in this case was a review of each of the forty five miles and a determination based on each individual beneficiar status and need as to whether or not the claim was appropriate and i think that that distinction is important when reading those provisions also i'd like to point the court to want to of the cases that was cited in our brief which is sound as county home health care that is a d c circuit opinion from ninety one it was before the statute was implemented that i have discussed here today with the two situations in which extrapolation and sampling were permitted but in that case i would argue that the court did confront something very similar an argument about whether or not you can have a rule of thumb provision in one place and statistically sampling in another and the analysis that they provided highlights to the court why it is possible  exactly what was requested at the first two levels of review but certainly i think there's no dispute that by the time of the third review by the a l j all the materials had been provided they were request and each of the experts who testified the independent expert from the court the expert formats met and the experts in health integrity all were able to recreate the sample talk about the sample and knew which claims were more  on that and i would suggest the court that in some sense the process of the administrative proceeding is to reach a singular decision it's to reach the singular decision of the secretary so in this case the administrative process occurred the balco made its ruling and that is the final singular decision of the secretary that's upon me i don't think anybody is hearing  c gives the standard of review when a referral by a c m s after participation is is made in c a measure which contractor participated in the appeal and the council exercises its own motion of authority that is where the limitation is it as review either broad public policy broad policy or procedural issue that may affect the general population or  currently is undisputed was that a calculation obviously on your side to your client side there was a calculation made and you believe that to be the correct number as opposed to the seven hundred something thousand out of that number column that number came all certified by the physicians so often what you'll find is a paperwork issue often see a mention looks for physicians notes in home health records in for home health notes in physician's records and so it makes it very difficult for a provider to know what to do the rules have changed as of late to for the home health agency to obtain the physician's records and to get tests at to stations from physicians to help in those reviews to just to support the certification more but again for purposes of your or your client's purposes the two hundred fifty eight thousand is a number that is generated by your client's examination of the forty files that i understand you correctly identified by the sample brand including waiver of liability where medical necessity or custodial care is it here and did you take the latter tack at all that is what we appealed on the on that  we prevail on those which we did prevail on one but but ok but the with the citizen call sampling you don't even know i mean of about if you were actually going to challenge that you could bring in the ninety additional case files i suppose and dump them in front of that here's what this proves that the a l j has it no at that level no jurisdiction here those are the ninety of us i have to be brought through the process those are the only ones reviewed we say in order to reduce the overpayment on the sample claim side we can win on those individual claims and on each claim that is reversed such as the algebra first one that way actually make a difference change the sample and they trample ation should be done a new as a thank you very cute thank you