that afternoon we have two cases scheduled for the south though that looks like a lot of moving parts on on down so let's get unnecessary cardiac surgery simply the closure of a hole in the heart called the phaeton for a mineral valley and he said cardiac surgery could you explain a little better i thought it was just they don't open to the chest for this right stent i think the process is similar i'm not entirely familiar with stent procedure so i don't want to oversell the comparison but the way this works is that a closure usually a medical device a closure device is inserted via the catheter and then the hole is found now  there are different ways this is sometimes done to get the right imaging to find where the hole is sometimes patients are placed under general anesthesia this stuff is not in the complaint and so i don't want to talk about it too much but just for the courts you know information  ication the procedure sometimes on with local anesthetic sometimes with a general and sometimes can be more involved than others the question is whether these procedures were medically necessary in the circumstances in which they were performed the complain alleges repeatedly and emphatically that they were not and to show that those allegations are plausible the complaint explain that there is been a debate in the medical community about whether you can perform these procedures for patients who already had a stroke and it is a stroke where you can't explain the cause and where they are not responding to drug therapy there has been no real debate in the medical community at all about whether you can perform in the circumstances alleged here that is before a patient ever he even has a first stroke and that is because to do this is frankly far beyond the bounds of anything contemplated by the general medical community and what's planted here is enough for the court to see that you have  medical history and each of the patients in question so your honor are doesn't get that detailed our client did personally observe certain procedures being for performed on patients who did not have the indications that would support th procedure and the understanding based on conversations had with other doctors at the hospitals where these procedures were being performed sometimes sixteen times a week eight times a day two days a week was that many cardiologists raise many concerns that patients for whom this was not necessary were getting the surgeries there's also the fact the intermountain hospital in two thousand and eleven suspended dr sorenson and then he's surrendered his privileges precisely because he was performing surgeries that were not indicated by the time i was that i thought that was part of the problem that the district court had was that there were there was not enough connection or information for the defendants to know really what  time with what diagnosis and what outcomes oh i was it was not medically necessary i do not think that that is what the district court held at the start i think the district court held as a blanket matter that unless s issues either a regulation or a national coverage determination barring the use of a medical procedure in purpose to clear indication then a claim for reimbursement can never be false that is the blanket holding of the district court and we think that that is plainly wrong for the reasons described in the brief most coverage decisions are not made by national coverage determination they're made by case by case adjudication and to say that you can never have a procedure there are patients for whom this procedure is medically necessary yes that's correct your honor and as we said there is ongoing debate in the medical community about this but there are situations for example if you had multiple tr are not a good candidate for drug therapy things like blood thinners then this surgery is generally regarded as a good idea well if in your complaint is you lump in all surgeries or did you exclude from the complaint allegations ones that were medically necessary so our complaint does not say here are some that were medically necessary the allegation in the complaint is that the identified surgeries were not medically necessary whether that is true or not is of course a matter of fact that can be proved a summary judgment or a trial what we know is that a great many of medical of the surgeries performed by dr sorenson surely were not medically necessary and when doing down the identified surgeries figuring out which ones were actually necessary or not that's a matter of the proofs are going to be a mini trial then on each each of these surgeries on whether it was or was not medically necessary ports are managing this issue in different ways because  arise with some frequency you have a hospital or pharmaceutical manufacturers or health care provider who provide services on a massive scale and they're alleged not to be medically necessary but there may be exceptions to that and courts are dealing with this in different ways what most courts conclude that this ultimately comes down to a question of the damages and they can do it either through statistical methods through an audit where some experts will go through the various claims procedures and decide which ones are necessary which ones are not necessary in some cases bellwether trials this was a good thing for his patients and that was enough and there's no way that can be a false claim when the physician thinks this is the right thing to do so where do you get an objective standard for the term medically necessary for the clearest place it's been written down is then the c m s medicare program integrity manual the relevant provisions are reproduced pretty much verbatim on pages three and four of our reply brief and i can show you  authoritative evidence derived from definitive randomized clinical trials or other definitive studies there are no such trials or studies supporting the surgeries here and i don't take the defendants even to dispute the second possibility is general acceptance by the medical community as supported by sound medical evidence based on and there are three possibilities scientific data research studies published in peer reviewed medical journals consensus of expert medical opinion i recognize authorities in the field or medical opinion derives from consultations with medical associations or other health care experts the manual specifically says and here i'm quoting again acceptance by individual health care providers or even a limited  described with respect to sorenson more interested in with respect to the hospitals how they certify so the hospital sorensen's form the form fifteen hundred had an explicit nation about this and it's very clear but i would say more broadly and this applies to all of the defendant medical necessity is a core requirement for reimburse ability you cannot get to reimbursement for unnecessary medical services outside a very very very narrow very very well defined circumstance or mental certain experimental procedures exactly  these would not qualify of that under any logical part in archery and so there is because it is so fundamental to the reimbursement decision it is implicit in every claim for reimbursement that the services were medically necessary is not how did the hospitals certify in your case because they weren't charging for his services that's correct the hospitals charge for their own services so when the surgeries are performed there performed at the hospital in their catheterization lab the usually and so lab technicians and esteems the ologists other support staff the services of those people the materials that they provide all of that gets charged to the government as well and now under medicare part a and part be the sort of different reimbursement procedures but for medicare part a which is hospital services the way this works is there are interim reimbursement riposte sought and at the end of the year there's a cost report and the two numbers are compared but the certifications are implicit in the interim reimbursement plus pressure to find that the surgery was necessary as opposed to the work of the nurses and then this just and so on so the defendants in this case haven't attempted to desegregate those two things because obviously i think you know if you have a surgical also facilitated the surgeries the allegations in the complaint say that both intermountain and st mark's hospital rolled out the red carpet for dr sorenson he kept their catheterization lab hopping and they were well aware that he was performing a large large number of surgeries there they courted his business actively when he threatened to move it to other hospitals and they were certainly involved they had an agreement he was going to perform these surgeries at their hospitals and i think that that conspiracy places him on the hook also for nia please the court sarah carol on behalf of the united states government has addressed both constitutional and statutory ins in this case and of course i want to be very careful to answer any questions the court might have about the constitutional issues but if the court doesn't have concerns on those i'm this court in the supreme court has said repeatedly that it applies to all fraudulent attempts to get the government to part with its money and in essence the bar just a couple years ago the supreme court reiterated that to the extent the courts are concerned about decide the question whether a clean for reimbursement from medicare was for a reasonable and necessary service is an objective one that you know a judge or a jury can and where did we get that objective standard so i would look that what you're relying on its decisions so the manual does not have the force of law so i'm i do not want to say that someone would submit a false claim simply by not not obeying the manual people's medical claim if they violate the necessary depends on whether there is published authoritative evidence supporting its use or whether it's generally accepted in the medical community i hear the relator has at least stated a plausible claim that those standards were not satisfied and the real leader has also at doesn't help you with the claims in the hospital i think that it goes most directly to the doctor's conduct in the doctor's answer yes but we also have you know these allegations that other physicians were expressing concern that one of the hospitals at least eventually saw fit to take action against us against this doctor because he was performing procedures that in the hospitals you endangered patients this doctor was performing these procedures allegedly inference if it's such a good claim why don't you intervene there are a number of reasons why the government might decide not to intervene in a given case and they some of those reasons are not there on the merits of the case i don't know exactly why the government didn't intervene in this case but we certainly think that the district court was wrong to dismiss the claim as a matter of law on the on the theory that it was that it was that it could not be a fall in the little time i have remaining i guess i would like to extend their pertinence i think it's important to just start by reviewing the bidding here i understood relator is opening brief to the arguing that these medical articles attached to the complaint would show the court that what dr sorenson was doing was outside the b factor for first drug and expressively the clients make any recommendation about appropriate treatment meaning appropriate treatment up to the clinical judgment of individual cardiologists and i think it's really important to understand the sleight of hand that they're doing here with the medicare program integrity issuing a local coverage determination like to the world here's what we're going to cover and here's what we're not and that is a relatively high standard but that is not the standard for evaluation of an individual claims in fact if you read thirteen point that standard is consistent with accepted medical practice now it is incredibly common for accepted medical practice to embrace debate uncertainty and a variety of different approaches to medical treatment what do we do with the guidelines that were promulgated by these hospitals were there guidelines within the hospitals your client said this is something that we don't approve no your honor the allegation is that in august of two thousand and  things should be performed and when they should and can we can we look to these internal procedures to determine whether or not these procedures that were performed by the doctor were medically necessary your honor i suppose it's one data point but the adoption of  an internal guideline by one hospital does not immediately make every other approach the practice across the country in ten thousand different hospitals outside the range of generally accepted medical i ask you a question in this way  is there any evidence that it is medically acceptable to perform this procedure for treatment of migraines your honor there's there's nothing of ads in the complaint about that they are resting their complaint on the allegation that read that they want to make is that if the h a n a s a are saying we are not sure about appropriate treatment for patients who have had one or two strokes then therefore it must simply must as a matter of logic be the case that  facts giving rise to a reasonable inference of liability in this context that means they have to plead facts giving rise to a reasonable inference that what dr sorenson did was outside the range of the accepted medical practice and they simply have not done and the district court correctly identified that the law in this circuit and every other as far as i'm aware is that you can't have either falsity or knowing falsity allege in a false claims act case unless there is some objectively clear standard if reasonable people can disagree it's not false or knowingly false and that's all this is about well let me let me pursue the little bit because even if a specific doctor who is wiser than other physicians surgeon thinks that this is a good surgery my conformant with very low risk and a host of prevent a lot of  stroke that still be not compensable under medicare because it's not generally accepted it was not generally accepted there was evidence that it was not generally accepted in the medical community and you just have one outlier doctor then no that would not be ok dr sorenson did was even inconsistent with these ha it's a guideline these guidelines never say that we recommend against the performance of these procedures in a circumstance where the patient hasn't had  so maybe my initial question was based on i'm sure it's based on ignorance to some extent but if there's a pursuit your there were debate whether this is a good thing to do even after a stroke and nobody's really thinking about doing it before strokes except perhaps dr sorenson then wouldn't they have written these guidelines the same way and doesn't the absence of something suggesting that there are doctors who agree with sorenson there's a substantial like your own doctors that agreed that there should be done essentially prophylactic lee possibility of this not being journalists i do think that the articles fairly read and read in conjunction with the separate gardens for pretty stroke patients demonstrate that there is a robust medical debate and  doctors and you know i think it's incredibly important to recognise that it is very very common for the range of accepted medical treatment for which you can build medicare to be very broad think about back surgery prostate cancer there are a lot of things about which the medical community is not wholly in agreement that does not mean that every bill submitted to medicare for prostate cancer treatment or for back surgery is a fraud and that is the relat how these arguments fit together before i turn to their substance if the court adopts the theories that any of the defendants have raised as to why the claim against dr sorenson fails the case is over the court he'd go no further and that's true whether the court reason with the district court's ruling that expressions of opinion scientific judgments can't be false under the false claims act or at the very least dr sorenson's approach comports with a reasonable understanding a reasonable interpretation of the law and therefore can't be a knowing or reckless violator there can't be false claims liability affirming on those bases and the case as to all the defendants but if the court were to reverse as to dr sorenson there remain important grounds to affirm the decision dismissing hospital defendants in a mountain and st marks only if the court were to reverse on all these issues would it need to reach the constitutional argument we raised we raised in our brief i'd like to begin though with the claim against dr sorenson and what is played in the complaint the central failure in the complaint is the failure to allege and objectively false claim the complaint please that p f o's closed that g f o's cause strokes that dr sorenson believed it was medically stroke before doing as relatively minor procedure to prevent that stroke from happening let me make sure i understand you said the complaint alleges that he believes this was generally accepted practice the complaint alleges  it was necessary medically necessary to close p f o's and high risk patients it doesn't address what dr sorenson's belief or knowledge was as to a generally accepted practices nor is that the test at least some of the framework the district court adopted which is extent dr sorenson actions comport with a reasonable understanding of the law he can't be a knowing and reckless violator that's the lesson of the supreme court's decision in safeco or says that where a statutory tax allows for more than one interpretation as to the relevant court guidelines someone who follows or acts in acts consistent with one of those reasonable interpretations can be unwilling and reckless violate or not the standard for liability under the false claims act so as long as cases law that medical necessity calls for him to make a judgment as a doctor as to what's medically necessary in an environment where the government hasn't weighed down and said you can't do this if there are two strokes in a national coverage determination in a local coverage determination or any of those kinds of decisions that were established a solid rule an objective standard that would balance the medical necessity of physicians and to be clear we're not suggesting there there has to be some of this will decision that this is not medically necessary for there for him to violate it if it's if there isn't any announcement maybe he's the only person doing what so the complaint violating the false claims act you're not filing the false claims act even if the government through its medicare contractors disagree and rejects that claim using the term polices medically necessary a doctor can think it's the right thing to do and it wouldn't be dead it would be malpractise to do it but that doesn't mean medicare has to reimburse so when you say medically necessary it seems to me you're using it three different ways here and i want to make sure you're distinguish ing between what the doctor thinks is good treatment and what is generally accepted in the medical community it doesn't mean that the government has to reimburse the government can decide after the claims emitted that it disagrees it thinks the treatment is not medically once supported by scientific studies or generally accepted in the community the c m s manual says that is one factor as the government conceded a few moments ago that manual does not have the force of law nearly violating that you dispute that that's the thing there i dispute that there are any adjudication any snow about not i'm sorry not about this particular procedure but about how you determine whether something is medically necessary do  short on time i'd like to briefly address the claimant that seems to be absolutely central to the case i'm sorry to pursue it now the question but you're saying that the the standard that's in the manual has certified medical necessity of store and since procedure that's in pages thirty nine and forty of our brief intermountain certified that what it did was medically necessary that if a patient under anesthesia you need a specialized nurse the in with other cardiac conditions as things that may contribute to stroke the specific language he was giving you about how individual doctors should make their own decisions is nowhere in the recommendations in fact there is no recommendation at all given after it talks about other cardiac conditions as recommending on that would be beyond the scope of this guidance what we have left is what i said before there is a little bit of a debate in the medical community about once you had a stroke and you have these procedures there is no debate about whether you should do it before you have a stroke because that idea is widely regarded by most people as wacky it is not an idea that it has been taken seriously and they have not been able to muster in evidence that it is and this is it this is an important point about the big picture here as well because what they say if you over and is that the authorities do not conclusively reject this an ambiguity in the authorities is not tantamount to rejection even if you accept that proposition is true we win decidedly because in order to seek federal funds in order to make a claim on the public this it is their burden to establish necessity our job is not to show this procedure has been generally rejected by the medical community we think it has been but we don't have to show that what we have to show is that  not been generally accepted that is we have pointing to the absence of evidence is good enough on our side and that is exactly what our complaint another small thing to clean up about whether the local coverage determination standards contractors make either a local coverage determination or an individualized determination under sections thirteen point three thirteen point five and thirteen point seven of the manual they apply the exact same standards the standards are not different they say that the complaint to silence about migraines the last thing that i want to talk about is sort of the big picture here and i want to reemphasize this is a case of the pleading stage so much of what they're talking about are factual questions did we know did we have a reasonable belief all of that is only we can only really ha out after there has been discovery into things like there's the enter at the pleading stage our obligation is merely to plausibly allege that these services were unnecessary and that they knew or should have known that the complaint makes th allegations quite clearly and repeatedly and the only real response that they've come up with so far is well there is nothing clearly prohibiting this they have not been able to cite a single shape guidance document from c m s or other authority in the context of a medical necessity determination other than the opinion below that makes the holding there are plenty of cases saying you need objective falsity but for the reasons your charts that you explained this is a pretty objective standard oh  and one thing i'll say about that just wrapped up so you know page three we quote in detail the adjudications that they claim does not exist which say this is how you would do to keep this precise question it is an objective standard or it has been met in this case and so the judgement