good morning planet misstep and webster i represent the plaintiffs in their challenge to the coding decision or realize or even according to the government the coding process under the health insurance portability and accountability a supposed to entail a grouping of like items to facilitate the efficient processing of medical care but the clothing determination at issue group the new enzyme have a medical device decision for two thousand and eighteen right yes but in that case the case is now changed pretty significantly in my view because we have a decision we just got a decision a continues your honor is correct that the original determination challenge was it was made in late two thousand and seventeen and since that time the agency has made a series of changes to but i mean assuming that this recent decision will now govern and you know there's a loose and they haven't technically applied this to the two thousand and eighteen years yet but assuming that all shakes out indicator but there are the in this eries of indicators are all part of the determination as to how to treat the problem there were there was a four zero three five code for hipaa purpose and long supplies together and he treated your clients product as a supply and you said that makes no sense this device or whatever it is that mimics pancreatic function it's just crazy to treat that like tape and syringes and stuff and that has a lot of force to it but the agency ultimately agreed problem in the sense that it seems like the parties are talking past one another let's say they got rid of the d and and the double zero but as a substantive mommer the agency it still understands lies or to be part of and terrell in camp and therefore take those codes away the action that they're going to take as a substantive matter would still put it under the umbrella of internal supply  and if that's true so it seems like i mean i don't think you just get this what you're really trying to get act is the substantive pressing determination and the question is have you shot a false target by indicator i think one thing that highlights the problem we have here is that the code that was issued just monday evening actually designates our product as a nutri rather than a supply but at the same time still tries to connect us to previously price competitively supply kit can you can you tell it's a neutrino says because it's in the forty one hundred is a building code that is an income by indicators that you dislike and that i totally understand why you want that i'm not sure it's what you asked for but it may be what you want the question i have is if this new building code works in the way that the government says which is to say that it enables appeals through the administrative through the normal administrative process that would allow you to attack the underlying substantive determination that relies or should be part of the bundle then there is that opportunity to make the argument that ultimately really matters both to you and i think to the government  is treated as part of the same bundle for which there is the daily cap if it's not treated as part of the same model for which there's a daily cap then it creates the possibility that there's going to be a greater reimbursement it doesn't create uncertainty but it creates the possibility that there's going to be greater reimbursement so what really matters to you is the opportunity to decouple relies or from the bundle and if that opportunity exists through the administrative appeals process and we can confirm that with the government but if that opportunity does exist through the government's changed what do you think they are doing when they attach the indicate indicator as opposed to the hip a code are they making a legally binding judgment under medicare or is this just the hipaa team giving some ultra virus advice about what might happen on the  their views on coverage and payment and then claiming that we cannot dispute that coding determination because what we're really disputing is going to get coverage when they're all intertwined what you just read makes it sound like they're saying that government that but if that's what that says then it sounds like that's exactly the kind of challenge that you want to bring which is to say this shouldn't been treated it shouldn't have been treated as duplicative because it shouldn't be treated as part of the same bundle it should be treated as something different purposes your honor the only reason there is there are other provisions of the regulations that the government has not engaged on that would that provide to the extent that there is a challenge ability to raise the kind of challenge that you want to raise which is through the minister process which is that we don't think realize or should be treated as part of the same bundle it should be given its own code and also all the accoutrements that come along with given its own with  code which is to say it's separate reimbursement let's suppose that that's true i know you just look suppose that's true if that's true does that satisfy you or do you think that there's something different about this other way that you could get a could has any ability to pursue the administrative claims process is because this work issued an emergency injunction in advance of the issuance of the injunction there was no right to appeal because all with the new but with the i thought the point of the new code that we got on monday because that equates it with the code that because of her it's definitely true that even about as a result of what we what we said but it equates of with that code in the sense that it gives rise to an appeal possibility through the administrative process well that's what the government's twenty eight j letter suggests but the only needs to which appeal rights were accomplished was through a special understood that it would not is it your position that but for that word or the ordinary operation of a test would bar yes that's my position in that order there would be no stop or something like it will kick again as to that potential for i don't believe that whatever explanation the government determination it could get give back to the question just so i make sure i understand your position before the government if i know you dispute whether the beneficiary can take the kind of appeal that seems to me that matters which is the kind of appeal that allows your give it to be made that relies or should not be treated as part of the bundle for reimbursement purposes i know you just keep that but let's just assume that the government says no in the administrative appeal process the beneficiary argument and then someone's going to have to make a determination eight he's going to have to decide whether they realize it was part of the bundle it does that satisfy you or do you think that there's still a problem there is still a problem from our perspective because it is very challenging for a beneficiary to even get to the point of being able to appeal we have a coding determination that  indicates to the whole industry that medicare is not going to pay for this product therefore suppliers don't want to furnish products that patients physicians don't want to prescribe the product because they don't expect that it will be covered in soot and they don't want to leave these vulnerable patients not the crap of trying to get a product that they're never going to be able to afford so the point is of that you may never have a beneficiary who's in a position to you to make use of determination and appeal at that disagrees with the price in determining what is that process the manufacturer doesn't ever have a right to pursue that it claims that right the one that they're referring to is the one for i'm not getting the coverage i should get what i'm saying is there if they hadn't sort of funneled everything into this coding determination to have a new product and it's not even susceptible of being grouped under something that's decision a coding just in europe as i understand it we've seen a pricing decision masquerading as a coding decision and that creates a whole level of complication so i'm trying to give you a hypothetical in which the pricing decision is not m me i thought the whole get your argument about gap filling was this other route i thought that was over the that was your argument is that there's this gap filling mechanism under which you know manufacturing can raise this claim and that's a different route from the administrative appeals process to the government for them to correct the gap filling to clarify in that situation the medicare contractor would be making a determination of price using the gap filling process because there had been no price previously set through that through that be schedule of a competitive bidding process as a new product relies more if treated properly will be priced by the medicare not argue it be it should not be priced this way it should go through that that contractor process always the three or and it's called gap filling and it seems like it's kind of backing into and provisional but if if your product came on line at a time when it wasn't made here it's i mean as i understood the work group does the coding and c m s does the pricing so there actually are two separate and i wrong two s comprised of people outside the agency and people within the agency and of those people within the agency there are pricing experts who are of the work rate and so i i think there is interplay between the pricing folks at the where or who would make the pricing decision and how what what would we look to in terms of if there were no doubt telling us provision well i think if there were with regard to this kind of in and enteral nutrients equipment and supplies are supposed to be competitive bidding and then based on that bidding the secretary determines payment amounts hurts so why so putting aside the gap filling if you now have a code is there and it doesn't have a price associated with it right so if is there another cycle when competitive bidding is going to happen and how do we know that this will not be competitively bid at that time we know because of the double o codes very well there is supposed to be another site i don't have particularly have been tejas to a firm in your position and it might be because it's kind of like they take the pricing that you're asking them trying to stem the ordinary regulatory process as opposed to the provisional council and process and whether there is if you were teed up to be priced in that regular process that's competitive what would be the appeal rights resulting so what do you do with again on under that statute there seems to be an obligation to do competitive bidding for nutrients equipment supplies right so once you get this separate code to follow down judge pillars decision tree right there should now in theory be an obligation on the secretary to do competitive bidding with respect to this new product that has its new code and as far as i can tell under the five that gets done and the price gets established the secretary stablish is a reimbursement amount based on that bidding and then on the question of review there's this b twelve provision which says no administrative or judicial review of the establishment of payments under b five which is the competitive bidding provision so i would think your answer is precluded once the competitive bid pricing is in place you're precluded from challenging back under this thirteen question and we do so so what do we how does that impact you know i can think of an argument that that just underscores the ridiculous aided nature of all of the medicare review scheme and the fact that you should be proceeding under it i can think of an argument that well if you can't get you're going to be precluded from review anyway you should be able to do this thirty thirty one and run right now well the problem is that even if even assuming that the agencies at some point in the future are going to do competitive bidding on the code that they just issued on earlier what is the legal status of an indicator determination that's associated with the code and i frankly don't know the answer to that but let me ask you one more question which is we don't have the competitive bidding at so presumably the preclusion of review provision won't yet have kicked in so what happens in the interim contractor are an administrative contractor so ok what do we do with this someone makes a claim for payment how did they i'm lost there's no competitive being in place yet but they're saying the code how do they in allies it itself would do that's not something that's dependent on the beneficiary or a provider that that process that would take place with respect to a beneficiary of that fishery would have to get a prescription for the product and the supplier would furnish the without the indicator everything work on your theory everything works fine right you can someone can go through the medicare scheme and make it an argument that you think will be successful based on gap filling at least until competitive is that the agency is sort of smuggling a magic here determination into the hc but coding decision that's exactly  fair characterization that is that is the crux of the problem that we have back to and but but isn't the upshot of that that we just we have to treat you know the hc for a piece of the case is this claim arising under the medicare act isn't it well i get a president can't make such a claim and the beneficiaries of the suppliers could only make such claims as a result of this court's injunction case that's an argument that that piece of big case arises under the medicare act but you can circumvent the medicare scheme because you can't you can't i'm sorry can't exhaust and there are practical difficulties with because this is treated as a do play right and then there's a question of whether that factor duplications can be challenging one thing very technical question which is with the indicators the letters the d's of the eyes and those things so one of the letters is a c yes if the indicator were a c that would be ok that would solve the problem we have here just so it's not a huge up not not that you need a code that doesn't have any indicator at all it's that you need a code that doesn't have the wrong indicator pricing and that would solve our problem yes ok we'll hear from the government than putting it putting aside the concession that you made in the you know walk atory litigation on appeal why wouldn't review be barred by not nine twenty six see which says that you are underpaid in the context of a claim that you then present to the agency and receive appeals process but in the context of presenting a claim which is what you usually have to do you can attack not just the outlook cation of the regulation but the correctness you can attack the underlying regulation which says this device will be classified in this way and produced this amount here i don't think there's a regulation directly obviously speaking to real agency would itself decide it could be raise them and i guess it just seems like there's not a clear answer because it's here's here's the concern that i have is that if the claim is raised and then the answer that the agency gives is there was no underpayment and the question is why wasn't there not a payment but because it's part of the bundle this is sort of like well you have to you have to miss the ball at all and if that's the answer that there is no underpayment claim is rejected because it's part of the bundle then there is no meaningful opportunity to raise the argument that they want to be able to raise it seems like it ought to be able to air the air in some fashion which is that it's just wrong to think of it as part of the bundle to refunds that you are first of all if you're statute does provide a process for e the authority of the agent to decide i don't think we're at the point of questioning the authority of the agency i think it's has the agency in a reviewable way exercised its authority to decide yes this is part of the bundle gor over it's not and the grounds on which it decided yes this is part of the bundle even though a whole list of other things relating to internal feeling aren't why do this and is that decision something that can be access has sort of subliminally made order sort of behind the scenes made a determination and that is making playing a bit of a shell game because i think this is their time with how to get back to that decision and i'm just trying to get your name that kind of initial benefit category a termination is something they'd buy again relevant to vision at c m s and part of those items here was the division of durable medical equipment and so this isn't something that's happening behind the scenes in the shell game your honor and again the medicare act so let's say hypothetically that black now has occurred and is denied reimbursement on the ground that if that an effort to recover their current code is a recovery under v or zero three five as i understand the medicare claims processing manual in chapter twenty section thirty seven dive to one ten about five says to be sorry it's duplicative you reach the daily have what are you complaining about or is it going to be actually this should be part of the same bundle you know why should we part of the same wonder because it's just like the other things that are part of the same bundle even though you say is just about time so at some vision or is your ultimate response that at some point it goes to court and then just gets raised and litigated before a court whether it should be part of the same bundle it could be your own or if it's an if the then the individual tries to do it to seek or hero and under the regulation which our special panel suspended the payment amount of program reimbursement according to regulation the payment amount of program reimbursement for which c m s for a carrier has sole responsibility under part b is not an appealable determination so there's no administrative appeal of that your honor again i think that the regulation that you're setting and schedule now or and i apologize if i'm being imprecise it's not my understanding that someone would be precluded by that regulating from saying i shouldn't be considered a supply in this bundle in the first place so the upshot of where we are the following that everybody agrees that the relevant issue at root is whether realized or should be considered part of the bundle i think everybody agrees that and then the upshot from the government acted now is there's a requirement that you have to seek relief from under pain before the agency whether you're going to be able to raise that thing that everybody agrees is that there are no maybe maybe not i'm not sure what you have to do is at least try to see whether we're going to give you the answer to that through the government process through the industry process you know where we are made and that may be where we are and it may be that you're right that we have to be there i have to say it's not terribly satisfying that the government can't tell us whether the issue that the government thinks is that will congress specify how how is it that all these other things that are going to you know be forty one fifty the forty one fifty one doc coded even though they also half to do with medicare does not meet again these are these are simply administrative mechanisms to help the efficient processing of medicare feeling and the fact that we're here partly about feeling good when in reality we're talking about coverage and payment issues or the difficulties correct that their suit is fundamentally disconnected from what they want and so you're the expert are some of these things that have a different america from the forty thirty five none the less also like as al christo was treated as part of the daily be forty thirty five allowed i know that some other codes are not separately priced but they have the same zero zero pricing indicator with the same d indicator i obviously can't go cold by code and i will be getting out way too far what would be your dept one and making a case to someone in the agency about the price that should be reimbursed for that you honor i guess in terms of how people might come to the agency it's quite commonly it's my understanding that as companies are developing products they come to the agency to see how are we going to become going to care how we make it again there's not a lot of the record here but there is a reference to the fact that the rest in fact did that with the agency that was the division of durable medical equipment policy that said he we think you're a supply and what is there is there a formal way to to make a rocker and submit an application for a price or anything like that that you're aware of i personally can't speak anyway i don't i don't know and i think again your honor of the way these things usually go all the ordinary course of business is that in the context of a country clean group you know when you think you know  guidance i've developed a prop a product and i'm not even going to know whether medicaid is going to cover it until somebody buys it at some market price i've set and tries to get coverage or that can't be that that that the whole pricing starts  simply having a new hole is not going to entitle you my itself to additional reimbursement and that is the crux essentially point is argument here and that's again why everyone has this kind of thing ever come up before it just seems odd and it seems like almost what's happened is that in every other situation if something is in fact a separate product it just gets a separate code and then nothing ever arises this is it like this kind of crazy situation in which something that seems in a lot of respects like it might you know have this must come up so what what happens in those situations when someone wants to say a word and i don't like the fact that i'm being grouped with a bunch of other things because it's compromising the extent to which i'm getting an economic return amount determination and our a panel of our corps said as a matter of provisional relief based on that representation perhaps it was by  that that would not bar administrative appeal is that is does that still apply to the new code or was that just a kind of provisional for purposes of that temporary potential effect going to benefits and the twenty nine to six regulation that you say age or honor would not preclude that again i think that's where i think the regulation is referring you are to things like appealing to direct publication of a fee schedule or things about that nature your honor not in the context of putting a concrete claim for benefits and saying that you are underpaid so do you just do you have authority to represent two was that if if  we accept your position and then the inevitable challenge is for all through the medicare scheme that the government will not assert that nine twenty was for claims that hadn't even attempted to be because it was i mean it's it's not all that hypothetical where the last part of your brief tells us not to worry about any of this because all of this can be here  way then just play it out so let's suppose that there's no preclusion because of use available and that the beneficiary has access to that and it practically is available for the beneficiary to do it and then the beneficiary seeks review of the no life under payment and then the agency says there's no under payment because it's stupid and then the beneficiary tries to say well it shouldn't be duplicated because it should be segregated out there should be separate reimbursement of the agency says that's not what this process is all about we've said it's duplicative that's it and then it goes up then what happens where and if that's the way things unfold because we don't know that that's not the way things are going to unfold so that's the way things do unfold we're at some point is there an actual conjoining of the issues such that the agency is making a review board assessment of whether realized or should be considered part of the year i don't know merits is the question of whether it should be part of the bundle and what they're saying is it shouldn't be part of the bundle therefore you have to give us a separate building code that kind of manifests that underlying merits determination  every is it does it just be indicator have independent legal significance to bind the contractors or is it simply presumably we're all looking at the same coverage well i'm just saying it did it may be a function of maybe a function of this indicator determination which i'm just having a hard time understanding i don't see any statutory or regulatory authority for it seems to be seems to be a medicare payment decision that's somehow mysteriously appearing in the context of a hit know what the answer will be from the medicare contract or if a claim to submit it because we have one and the answer was that the benefit for this service is included in the payment allowance for another service procedure that has already government on the one hand we're getting the indicator code which seems to say that for reimbursement purposes they still regard they still regard this device as part of the supply bungle on the other hand we're getting a coding decision that seems to suggest that someone in c m s for some purpose or another now thinks but it might highlight the difficulty of our trying to jump in here at this stage and figure out what is going on with these indicator codes in an arguably abstract context where we know how something that feels like a concrete payment happens normally and normally if there is a new product manufacturer goes it gets a code and the code is seen as an act to reimburse them what has happened that is very unique here is that happened other times too and then the and then someone would have had a dispute about whether it was appropriate to code it so that it's part of the preexisting reverse make up well i think that as you might imagine i mean if actors are reluctant to sue the agency especially when the agency is consistently taking the position that what it's doing is not reviewable and this is for the reason i just stated a rather anomalous situation but the national definitions of codes and it's an indicator code they get tax codes and it's in that language that really that sole responsibility is the language that is used in the in the regulation for a five ninety six that we've been discussing we're talking that four or five to six talks about the inability to challenge a payment determination for which stand us has sole responsibility after that as an example of how this would play out if the appeal  allowed to progress under the regulations are rejection of a claim because it's a claim would not progress and there is no expert in judicial review and this is in a situation where that claims are they want the reality is that medicare is believing it is leading the charge is setting codes of the rest of the industry is looking back and so i think that i think this means if you want to know how it's going to be covered  medicaid contact medicaid but in reality most medicaid programs are following medicare and so there is an answer out there in the market that answers your question