please the court my name is howard sure and i represent the secretary of health and human services in this matter this is a case that involves the post payment audit of claims submitted by maximum comfort on behalf of medicare benefi for power wheelchairs i'd like to address essentially three three parts to the argument the documentation requirement which is the key issue whether maximum comfort is entitle to a waiver of liability under the statute and last whether they've actually preserved any other issues if there is a remain and by virtue of a single footnote at the end of their brief as you the court is well aware the first issue the documentation issue has been decided at least by one court of appeals the gulf coast case in the eleventh circuit in which the court adopting much of the analysis we presented in this case held that the provision relied on by the district court in this case did not accomplish what the district court claims secretary can use in determining whether or not to reimburse a claim for a power wheelchair and in the eleventh circuit decision the court said that that provision does not state that the certificated medical  sity is the single or sole or only documentation in fact all that is a definition that defines what is it if you get a medical necessity is for purposes of noting suppliers the limitations suppliers in what they can fill out on a certificate of medical necessity otherwise the statute according to the eleventh circuit adopting our analysis here clearly and unambiguously provides the secretary with authority or have a and thirteen ninety five l e and other provisions all flied the secretary with authority to seek other documentation in fact under the district court's determination in this case the only area of the medicare statute that the secretary would be unable to request other documentation in order to determine whether a physician's certification is accurate is in the power wheelchair area under the district court's determination this is issuance that would have the final word as to whether or not the power wheelchair ought to be reimbursed and we think that stands the statute on its head and that's the position that the court in fact excepted in the eleventh circuit decision i may be jumping ahead and to do you think you're going to redress in the future but i it seems to me that one of the things  motivating the district court from one from what the district court said was that if more is required then the supplier really has to ask for that more to protect   i mean not if i'm making delivering wheelchairs i get a certificate of medical necessity and that may not be enough to protect me if i go ahead and give the wheelchair just on the basis of that so that means i would have to ask for more and then i have to become kind of a medical specialist to look at it and decide whether it's really medically necessary and i'm just a wheelchair builder just a wheelchair builder but you are the entity that submitting the claim and you are the entity that's getting the reimbursement and through the carrier issuances and in this case you are also informed that because you are the submitter of the claim wheelchairs and i've got to decide whether the doctor had adequate medical support for the opinion erosion of that certificate well you don't have to actually take an assignment in one of the the assignment which is what in fact maximum comfort did in this case is one way of making a claim the other way to do it and there's nothing that compels a supplier to make take an assignment and take the risk that maximum comfort  take the risk the maximum comfort took in this case under the hypothetical the opposing judge candy they could have to simply had the beneficiary make the application first based on medical records and then if in fact it was approved by medicare then there would have been reimbursement but they chose that the assignment issue for someone they take that assignment route as the eleventh circuit rule then in fact you have to assure yourself because the stat the records to support the certification when this audit was done some of the instances where there was only answer to if you could of medical necessity are there were in other words reimbursement approved in some cases where there was only a medical certificate i'm not aware that there were there were many cases at the yale j saw remember that this was  from the dishonest or fraudulent doctor and that's on the one hand and that's why one of the reasons why the post payment on its exist but on the other hand you just as a practical matter it seems like an odd all what function does it serve then given it's limited information and it's limited reliability the effort was to streamline the process in order to allow prompt reimbursement as an initial matter subject to post payment audit so you have the cases we cite for example that make that statement of the american ambulance case out of the eastern district of pennsylvania i think which goes through a nice analysis relying in part on the second circuit's case in the bogner decision but the real question in the case is what does because this is where the district court looks his whole opinion what does thirteen ninety five and j to the mean and in context all it is is a definition for purposes o this paragraph meaning the certificate of necessity paragraph and the purpose of that definition is because in one thousand nine hundred four in which this provision is introduced congress was for the first time after a four year saying suppliers can all fill out the certificate of medical necessity but only referring back to j to read a only the provisions that deal with the administrative aspects but not the medical part roman numer medical information when they shouldn't have been so now four years go by in the one thousand nine hundred form amendment comes into place but what did it do it you would have expected if congress moves really adopting a substantive provision in it it would have done something more then just make this a definitional statement limited to the pair purposes of this paragraph it would have said with respect to durable medical quitman unlike every other provision item in service in the medicare statute we are going to use the certificate of medical necessity as the documentation for that the secretary can use and no water you would have expected that kind of language somewhere in the statute whether it was in one of the auden provisions were in actually thirteen ninety five x and the provision which defines it talks about the fact that your little medical equipment is a covered item in the statute but nowhere a two thousand and three amendment to the statute and the secretary and that's that that amendment required physicians to have a face to face meeting with a doctor with their patients that are going to jets power wheelchairs has now moved through the four ten point thirty eight regulation to a process for power wheelchairs alone where the secretary requires the following and the brief summary of  sure and those are the ones in the excerpts of record at page sixty eighty those issuances made all this clear as far as we're concerned we cite to the particulars in those particular provisions for example i'm just not understanding how the this wheelchair maker is supposed to know what if anything it needs beyond that until after it's too late because it's being on it yeah well you know what the coverage criteria are namely that the individual must be better wheelchair or chair bound that's one of the criteria for totally non ambulatory upper extremity weakness in the body and be able to have to get use the wheelchair in the home for one thing and not be able to it's a checklist and the doctor's checklist it is very brief and it's just seven questions doctor checks those questions and that's always sort of fine to  we hope that he has the records to support that evidence like from the certificate of medical necessity that's a form it's a form it's a it's the supplemental excerpts of the record page won it's put out by it's one that's produced exam excellent example of an analogy i would have drawn also that that you get your reimbursement a refund under the tax code or by submitting the ten forty but subject to audit and in this case only point i suppose that the recent regulations you are reading are directors by a secretary am not a problem we have here namely that most of the doctors just wouldn't respond and give additional information so the suppliers were stuck they didn't have a they couldn't get it i just knew the last part is well if they didn't have the if they didn't have most of the doctors just wouldn't answer the mail or something write it and then the question would be after a very long administrative process where the secretary consulted with every major medical group over a multi year period to determine which questions the doctor should answer so that when the doctor answer yes or no the doctor could then sort of pie under pain of perjury that the bait patient had a medically necessary reason to get the power device in our supplemental excerpts of record at page one we set out the form so that you can see in which questions the doctor has to answer now in an acting than one nine hundred ninety four amendments congress made it clear that it did not want to supply or attempting to make any medical judgment at all the purpose of those ninety four amendments was to put the onus of making medical judgments on the doctor and leaving to the supplier the business of a procuring the device making sure that it was at the right code administrative flee that it was at the right price that the secretary had approved all of the medical decision be made by the doctor and so this form which took two years to develop has very particular eyes questions and if the doctor answers those questions affirmatively and then signs a part  the pressure on the supplier to try to second guess the judgments of the doctor so that the doctor can do what the doctor supposed to do which is to to look at the patient and say can the patient survive without having this device in is that something that the patient absolutely has to half the supplier isn't part of that decision making process at all but the whole idea behind it i mean for act was to bifurcate the responsibilities between the supplier hundred ninety four there was a piano plea of confusing forms and means by which suppliers would attempt to submit information to get reimbursement and what congress was attempting to do here but it wasn't going to engage in a completely radical overhaul because some supplier said it's easier for us because of the relationships we have with doctors hospitals etc to provide the well form of information so congress  he can't fill out the medical information the doctor has to do that but then in defining what the c n n provides and this is further down at the definition section congress specifically provided that for purpose paragraph the term certificate of medical necessity means a form or other document containing information required by the carrier for purposes of getting reimbursement the carrier litigation and post reimbursement audits how can we best ensure that the patient gets the device the supplier gets reimbursed we're going to decide what the questions are and they spent two years doing let me explain that the audit process has to ensure that the supplier has the original of the c n n and the original is the original signed statement by the doctor and that the audit would ensure that the administrative parts of the scene and form have been properly adhere to by the supplier that's what the statute says the suppliers are responsible for is this the right product code is it the right price has it been done according to the administrative to provide the administrative information but he doesn't have access to the very private medical records that the patient has has provided to the doctor and that the doctor is filled out so you would say the tax analogy is all wrong because circumstance chicha try to would be the doctor if you want to audit the doctor to determine doctor did you have a medical basis for signing to this year and then under pain of perjury go look at the doctor's records whe fill out if i'm the government contractor check i got that but the government has the right to come back and put on the government contract or in this case the supplier to be able to provide that information to make sure that audit what is the underlying documentation for the check mark is that what we're really getting to but the whole point is second guessing the medical judgments of a doctor if you're a supplier in your own business and i would like to point out that my client was put into bankruptcy because of this very practice by the medicare agency to take back what they had been promised there was no question there was no question of of medical necessity there was no question of the proper price there was no question that the doctor had signed the cmin it was simply because doctors failed to respond when the government audited and my clients left holding the bag for what the doctor failed to propel what how is the situation going to change  establish the principle that it can engage in arbitrary audits and put the supplier on the hook when the supplier doesn't have backup medical information now because the process took its time winding its way up to this court the secretary decided we can't wait we're just going to launch ahead so they launched ahead gauged in a legislative modify modification of regulatory changes so now as a test case the only test guinea pig here is my client which is left holding the bag and in for prospect of reasons this case probably doesn't have the significance that the government thought three years ago when it decided to appeal judge knows yet beginning in two system are having to come up with medical information they're having to hire doctors they're having to get other relationships with doctor so that they can try to verify after the fact in ways that congress we submit didn't medicare reimbursements is simply doing reimbursements at this time and the other cases that the government size the mckinsey case in the gulf coast medical case those clients are out of business they're in bankruptcy because their only asset is the claims that they have in litigation for trying to we claw back the amount of money that the government took from them after claiming they didn't have sufficient documentation so what we have here is a situation where the definition so as it's information required by the carrier they get to decide whatever that information is they can write the cmin however they want they can put whatever questions on that form they want they just have to get the doctor to sort of fight to the answers to those questions but if the doctor does that it's not appropriate it is not what congress intended to put the supplier on the hook for that doctor's failure to but it thirteen ninety five p congress provided that if there was a reasonable basis for the supplier to think that it would be entitled to reimbursement and something happens that would cause there to be a change in that the supplier shouldn't be on the hook for determining it its failure to get reimbursement should be entitled to it we submit this is the perfect and classic case for application of that waiver that predated the important statutory and regulatory changes that was subject to my client then they are suggesting that the supplementary documentation that was five virtue of guidance issued after the claims  ed in this case should nonetheless have a retroactive appeal we've we've noted that in a footnote in our brief i think it's footnote twenty five but the bottom line here is that my client which has done nothing wrong except an able to persuade the doctors to prescribe these devices for their patients to cough up the relevant documentation to support their claims that's it and that isn't a sufficient basis under the statute to do neither and there we embarrassment that they in terms of the notice and waiver issue you cited i think up to page seventy seven the government relies on excerpts of record seventy nine which is another age in the manual that has to do with supporting documentation is that the page that you're saying was and after this dispute or is that a page that was in effect during that is neither ok it was what you're saying though is that the seventy nine whatever we may or may not make of it that was on the table and in existence before this certificate was issued correct it was and what i think you know we have multiple arguments for this judgment for one thing these are not entitle to any kind of deference these are not initiated by notice and comment will making they are simply a private insurers guidance to what information they care the supplier may have tried to take into account and i would submit that if you read through this whole thing they point in opposite directions and they point in opposite directions because they're reflecting of the old regime if they aren't entitled to provision i think the waiver provision is entitle to is it is intended to protect suppliers who are making a good faith effort to comply with the wolves in the statute as they are mandatorily imposed on the suppl when did this case go to mediation in the ninth circuit it did well it was rejected because the government basically said this is a test case if they got secretary wants to bring the circumstances of now changed on the testing part of it anyway correct i won't speak for the government or our perspective from our perspective this case is about our the money that's being held up that's all that's left is the money from our perspective that's certificates are from january one ninety eight through january fourteen or so ninety nine i point out that the c n n needed to be uniform because if there wasn't a uniform submission and these these things are also done with tronic lee and most of these form government of mexico i actually thought the court will last us no this case was in mediation and i didn't ask if it was a mediation i asked if it had gone through the mediation process and you know there was no so my question now is is the money the only thing that's in dispute here or will be something more decision will affect the other cases and high point if you will from the district court then i think what the secretary did