when it's your time and i'll try to help you as well thank you your honour's this case is about what protection a company is entitle to when medicare makes varying coverage determinations about a device based on the same evidence and medicare regulations and the social security act state that if a supplier cannot reasonably poor see that specific claims will be denied the medicare will make payment in this case are us medical provided advice to medicare beneficiaries and when presented claims for that device to medicare the vast majority of claims are paid and when there are periodic denials most of those denials reversed reversed through the appeals process the question before this court is whether the specific denials in this case were clearly foreseeable to r s medical and i think that our us medicals position and its entitle ment to that protection and limitation of liability can be appreciated by looking a single document in the record the spreadsheet at exhibit number two thirty six and that is a payment variation spreadsheet and each line represents the claims for a particular medicare beneficiary and if you drop down to about line sixteen and you put yourself in the shoes of that medicare beneficiary you go in and you say to your doctor my knee is hurting me and your doctor says well i reviewed that peer reviewed literature and there's this device which has been cleared by the f d a as safe and effective for the treatment of osteoarthritis for symptoms and other pain but medicare has not yet announced its coverage policy how bad your need has to be for medicare to want to pay for this that orissa medical should have foreseen that these specific claims were denied then yes that would be for the secretary what effect does it have at all that we had this previous case in two thousand and two where there was substantial evidence  support the appeals council denial of coverage for this need in that case you're on the question was was there evidence did the secretary provide substantial was there substantial evidence to adequately explain why she denied it but explaining why a claim might ultimately be denied two years later does not address the issue of foreseeability so into it why not in terms of the whole issue that was on the table back then is essentially the same issue in many ways you know would be because this court looked at did the secretary adequately explain why it denied those claims later on in two thousand and eight but the claims pending before your honor in two thousand and six so how could a company you know in two thousand and six then in two thousand and eight you would find that the secretary adequately explain why those claims were denied well what if anything changed i mean in terms of in terms of this for c ability i mean you're argument so at the time as i stated when arsenic was presenting these claims the vast majority of them were paid so like if you look at that example in line sixteen you went into your doctor they prescribed it and the first four months the so the first claim goes in and so you sign that form saying if medicare doesn't pay for i will i will pay for it that's what i've been a fishery notices and then the first claim goes then and it gets paid and you go who's ah i'm not going to have to pay for medicare is going to pay for said that why doesn't that demonstrate that our us medical knew or at least had could reasonably be expected to know that these claims would be denied because because because according to the claims process in manual those notices don't get sent out unless there is doubt that there will be coverage in the first place that is correct your arm but also in the medicare claims processing manual chapter thirty section thirty point one point one it states if you give an advance beneficiary notice and there is subsequent in fact in two thousand and six our us medical stop sending out ab ins to anybody because it's experience was the vast majority claims or anything if you stop sending out the advance about two thousand and six year on  denied it's tonight on the basis that there are insufficient studies that show this device works there's not sufficient evidence to show that this device has been accepted by the medical community well your honor you would expect that it would be denied based on studies because you just had four months of claims the not i mean paid your honor on those exact same studies and so are us medical appealed those denials thinking they must be erroneous in my example on the six month when your claim went in it was paid by medicare and the seventh identify why one specific claim would be paid and why one would not and so therefore it would not have been foreseeable there was nothing that was distinguishable about the paid claims from the claims that were not pa by insurance companies workers compensation plans but more importantly the vast majority planes were being paid by medicare itself which necessarily meant that there had been determination that the studies did show it was effective i thought that a slate as the summer bases some claims were knives saying that they were not sufficient studies but even claims that were denied on that basis routinely were overturned through the appeal process your honor and in fact when i say a large majority claims are paid less than one percent of the claims were denied on the basis that this device was experimental and investigational so yes denials did occur but they were routinely being overturned in the senate the last issue that the current the secretary raises this it well arse medical should have known this device was not covered based upon denials that accrued in two thousand and four and two thousand and five well your honor those are claims that were denied when the cup when this device was billed under miscellaneous code and almost every device and service in our country when it's first offered to medicare beneficiaries  under miscellaneous code he used that code to acquire the evidence to show substantial adoption at the end of two thousand and five record support for the proposition that the denials were overturned on appeal that the yes your honor if you look at the second of this decisions that issued in two thousand and six there were seven decisions issued partially for i'm sorry in two thousand and six there were five fully favorable decisions finding this device was was work was generally worked and was effective for those beneficiaries and it's also so in two thousand and five there were five i'm sorry two thousand six there are five fully favorable decisions and there are two partially fable decisions and in two thousand and seven there were one hundred in one thousand final fully favorable decisions that this device generally worked and worked for those medicare beneficiaries you may want to say the same time i do have one question that has to do with the ceiling of the record if you would stay and answer that because my note says that the entire excerpt of record was filed under seal but the briefs are not filed under seal correct so why is the entire record filed under seal yes ok well i just just as a caution everybody you know we get these records as a matter of course people try to file the whole thing under seal it impedes our ability to even write a decision in a case so it's best not to file the whole record under seal for future reference thank you your honor may it please the court i'd like to start by addressing section four eleven point four zero six d one which is the provision in the regulation that states as a matter of law that a supplier is considered to have known that services were not covered if the supplier informed the beneficiary that the services were not covered in this case for the claims issue r s medical supplied the beneficiary with an advance notice that stated we expect medicare will not pay for the items or services that are described below in each of those claims so that should in the case right there that is a basis for for affirming the agency's decision for affirming the district court's decision which were affirmed the agency's decision that r s medical knew or should have known that the devices would not be covered and again to focus on the standard of review counsel says slightly misstated that the standard is whether substantial evidence supports the agency's determination that arse medical knew or should have known and under d one there is no requirement that that they had to clearly know and we think that under  one it is clear though because they issued a b ends for each of the claims that issues that specifically stated that they believe expected the device would not be covered doesn't matter that these notices stop being sent out in december or in mid two thousand and six i think opposing counsel said what first of all you are that's factually incorrect for each of the claims that are at issue here there was an advance beneficiary notice that was issued including one that was issued its latest september of two thousand and six so it's just factually incorrect to say that they were stopping issued and in mid two thousand and six but more importantly in our brief has citations of the particular notices that are at issue for the claims that are continued to be at issue in this case and for each one of those claims there is a notice so i don't think that that impacts it in addition there are four other district court case ending that have been officially notices that were issued many in the latter half of two thousand and six and even some in two thousand seven so we think as a factual matter that's just incorrect next i wanted to clarify a little bit about the timing of the decisions that are at issue here there were four appeals councils decisions in two of those the appeals council found that the beneficiary was liable because the notices shifted liability to the beneficiary so those are no longer at issue in this appeal because in those two cases the beneficiaries been held liable so it's irrelevant whether or not our as medical also knew that the device wouldn't be covered so for the two remaining decisions that are at issue and that's the five thirty five decision and the four sixteen decision there are nine beneficiaries with claims they were held to have in effect it ineffective advance beneficiary notices and just to be clear of those i believe sorry almost eighty percent of those were issued the claims that issue were for the first half of two thousand and six and so when they're talking about a number  of decisions that happened in august and later of two thousand and six that's after these claims were that the services were provided for these claims in addition the two thousand and seven l j decisions that they're relying on again those are after the time period which these services were provided so they're really not relevant to the question of what are its medical knew or should have known at the time that it provided these services and again just to you know they make a lot about the sort of  the tide turning in what was happening in terms of coverage at the lower lowest level of the city by the contractors you know in two thousand and six and later and you know this court can affirm under four eleven point four of sixty one without even addressing that but if the court does you know want to address that i would just like to point out that there are their statements aren't supported by the record they rely on four pieces of evidence one is the charts that counsel said was the most important piece of evidence  that are at two thirty six to forty four those charts are are of by on a care claims not are as medical claims so they're not the claims that are at issue in this case next in their brief they rely on e r three seventeen through thirty six as claims that were paid in two thousand and six if you look at those those are actually claims that were paid under the easy one three nine nine code in two thousand and five and then one claim that was paid in two thousand and six says we are not quite as vers is or where they where the record site is sure it's in their brief they cite are three seventeen through thirty six as establishing that the vast majority of claims were paid in two thousand and six and actually those are those are evidence of five claims that medicare paid four of which were from two thousand and five and one of which was from two thousand and six so again that doesn't support their broad statement that the vast majority of claims were paid in two thousand and six and they rely heavily on a an a the rest of which were issued after august of two thousand and six and so they're they're really not relevant for the claims that are still at issue on this appeal which again almost eighty percent of were from the first half of two thousand and six and so i just wanted to clarify that about the timing of what's going on in the broad statements that they're making about what was happening you know even in later years it's really not relevant to the question before this court and we think again that there are three independent bases as we laid out in our brief for why this court  affirm the agency's decision on substantial evidence grounds used all your time i give you a minute in rebuttal of course thank your eyes again i commend you to chapter thirty section thirty point one point one which they said if a subsequent claim is paid that negates the effectiveness of an a b n is imputing knowledge  i claims your honor when the secretary exercise extraordinary flexibility in making coverage terminations out on a claim by claim basis revisits not only whether device is appropriate for an individual but whether device works at all no no provider can reasonably foresee that a clay specific claim would be denied and in this case the vast majority of claims presented were paid and nothing distinguished the pay claims from the unpaid claims nothing and so therefore i believe are as medical a protection of the limitation of liability act your honor thank you thank you both for your argument this morning international rehabilitative sciences versus leavitt is submit