Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia CAC Meeting - November 12, 2019 - JE Part B

LINDA MEYER
Thank you. Um I am Linda Meyer. As I said, I am the Medical Policy Manager for Noridian Healthcare Solutions across all four of our contracts. And today we welcome you all to the Contractor Advisory Committee Meeting for Fluid Jet System in Treatment of Benign Prostate Hyperplasia, um the LCD. I will be the initial facilitator, handing it over to Dr. Larry Clark, our Medical Director, leading the policy development for this medical policy. Um as some of the protocols, that maybe if you tuned in early um some of the process that was discussed is that um I'll hand it over to Larry, he'll do introductions so CAC Members can introduce themselves, give their background and then indicate individually so we have a record if there is serious conflict of interest. Then we'll go through a series of key questions, and they will have a phenomenal discussion on each of those questions, and then we will conclude the meeting after those discussions. Um knowing that process is forthcoming, I now will turn it over to Dr. Clark.

LAURENCE CLARK, MD, FACP
Hey, thank you Linda. And um you are right; this is going to be phenomenal. And, you know, I always feel you can never know too much about BPH. So, um I want to thank the people who have stepped forward to help out with this. Um Dr. Rob Lurvey, if you recognize the name, his only conflict is that his uncle is um my career long mentor and friend, Dr. Art Lurvey. He is uh an independent thinker who helped me recruit some real talent both from our jurisdiction and from the National AUA and is faculty member at U. C. Davis. I believe also on the call is Dr. Joel Funk from the University of Arizona. Uh Joel, are you there? He may not be in yet. Dr. Thomas Chi from UCSF, University of California, San Francisco. Dr. Chi? Hello? Any luck confirming these folks are on the call?

LINDA MEYER
We will do that, Dr. Clark.

LAURENCE CLARK, MD, FACP
Super, just do that on the background as I introduce others. Dr. uh Tutu Falk of exceptional contribution at the national level of the American Urologic Association. Um Dr. Lane Childs, who I believe is with the Grainger Medical Clinic, Intermountain Health System, and um a significant leadership position with the AUA. And uh Dr. Jonathan Rubinstein, who I believe who is now called United Urology, but holds several key positions with the American, current American Urologic Association Board and management. Dr. Childs, are you there?

LANE CHILDS, MD
Yeah, I'm here.

LAURENCE CLARK, MD, FACP
And your Achilles is doing okay, right? Or is that Jon?

LANE CHILDS, MD
That was Jonathan, sorry. I stepped in a little too early.

LAURENCE CLARK, MD, FACP
Okay, we are trying to get - no, that's quite alright. Trying to get our other panelists onboard. I heard someone.

LINDA MEYER
This is Linda, we are working to get Dr. Chi.

LAURENCE CLARK, MD, FACP
Okay.

LINDA MEYER
Has any other CAC Member joined um that has not been announced?

UNIDENTIFIED CAC MEMBER
I think Dr. Funk is uh on the line. I think it's just a microphone issue.

LINDA MEYER
Thank you. Dr. Funk, are you able to hear us yet? We've un-muted your line.

JOEL FUNK, MD
Can you guys hear me now?

LINDA MEYER
We can. There is a bit of an echo, so as long as your um, just a verification that your phone is not on along with your um media electronics feed through a computer, otherwise we can hear you.

JOEL FUNK, MD
I think I've got it fixed now.

LINDA MEYER
Great. And I believe we have everyone. If all the CAC members can show that they are un-muted, if not we will un-mute you so that you can do some discussions. And um we are working to get um Dr. Chi. So, if you want to continue.

LAURENCE CLARK, MD, FACP
Okay, super. So, we have now Drs. Lurvey, Funk, Childs and Rubenstein onboard right now?

LINDA MEYER
That is correct.

LAURENCE CLARK, MD, FACP
Super. Thank you, Linda, and let's begin. And for the first time that each of you speaks would you please just give a two-sentence conflict of interest. All of our panelists have already um filed formal conflict of interest statements, uh and they all know that they will be recorded as part of today's deliberations. Um I want to thank again Dr. Rob Lurvey for helping me uh get uh the panel assembled. And, Rob, in our preliminary discussions uh I think it was you who led me to a paper, Roehrborn, uh Teplitsky and Das in August 29, which kind of categorically stated "critically, in head to head comparison with TURP, Aquablation has equivalent objective results with much shorter resection times and significantly fewer sexual side effects." And I think this was one of the things that sort of predicated our taking another look at this um. You know this was an August 2019 reference, and several of the contractors had come to a position of noncoverage because the literature was not really mature. And I think this might be pivotal in kind of opening a new discussion. So, would you, Rob, you know, just give a brief intro, uh a two sentence COI, and start us off on what you think of that paper, uh and do you think I characterized a change in opinion well?

ROBERT LURVEY, MD
Yeah, sure. Um I just want to pull up my notes here to make sure I'm most on point. Um Rob Lurvey, I have no conflicts of interest regarding this, as of what Dr. Clark previously mentioned. Um and to date I mostly treat BPH both in the operating room and the clinic. Um bear with me while I just pull up the Roehrborn paper though. Um but from the other WATER I and WATER II trials, I think that we see that uh there is uh no statistically significant difference in the uh patient quality of life outcomes or in the um patient ICSS scores uh between TURP and the Aquablation procedure. Um and we do see uh some uh improvement over retrograde ejaculation with the Aquablation. And of course, we uh are still not sure as to why that is.

LAURENCE CLARK, MD, FACP
Could you repeat that last point about what you are not sure of, Rob?

ROBERT LURVEY, MD
The mechanism of action for why the Aquablation procedure does not uh lead to the same amount of retrograde ejaculation, or dry ejaculation, as the TURP did in the head to head trials.

LAURENCE CLARK, MD, FACP
Right, okay, yeah absolutely, I have that written down. But it is a uh statistically significant benefit that that side effect is definitely lower, right? So, so I have the right understanding of it?

ROBERT LURVEY, MD
That is correct. Within this trial that side effect was uh statistically significantly better.

LAURENCE CLARK, MD, FACP
Great, okay. Um Joel, Lane or Jon, anything to amplify that? Do you think you agree with that characterization? Is there anything else you can talk about resection times and sexual side effects?

JONATHAN RUBENSTEIN, MD
Dr. Clark?

LAURENCE CLARK, MD, FACP
Yeah?

JONATHAN RUBENSTEIN, MD
Oh, hey, it's Jonathan Rubenstein. I can, I might be able to give a little insight into that, into the mechanism of action. So, when you are doing a TURP and you are scraping out prostate tissue you are a little, you are looking, you are just trying to scrape whatever prostate tissue you can. And you end up taking away down a lot of the bladder neck. What's interesting about the Aquablation technology is you actually do a transfer to ultrasound; you sort of map out the tissue that's going to be resected by actually using the ultrasound itself. So, you can actually outline the amount of tissue that you want to get rid of. Therefore, you end up sparing the bladder neck. Whereas when you are doing a TURP you don't really know exactly where the capsule is, and you are just sort of cutting and saying hey, there is some tissues, you know, just kind of chop it away. You know, it's the difference between, you know, being in the inside of an orange and just trying to chop away at the pulp of the orange, versus having an ultrasound that's mapped out where exactly the pulp is, and then having the computer and the robot automatically take away just the pulp, leaving the rind intact. So that's the difference, because you actually then get a better understanding of where the capsule is of prostate, and you are able to spare that and the bladder neck. That's the difference between the Aquablation and the TURP, and that is why most likely is the mechanism that, or the antegrade ejaculation is spared from Aquablation uh compared to a TURP.

LAURENCE CLARK, MD, FACP
Well that's very interesting. Um if you don't mind while you are talking about this, I'm going to jump to sort of another question that I noted. This technology is kind of different in that it has a computer-defined surgical field. It's also ultrasound guided, and the actual performance is robotic. I mean I thought that was uh particularly unique. And uh do you think this confers any surgical improvement in outcome?

JONATHAN RUBENSTEIN, MD
Yeah, and those are personal opinions, I think it does. I think it does. I mean you can imagine, again, a situation where you're you're you are trying to use some visual cues during surgery, and you are just cutting into some tissue; versus having pre-planned out, you know, the areas of resection. Uh I mean I really think um that this is a real disruptive technology, and I think that it's very unique that it can happen, you know, from the prostate. You can imagine if you are doing a partial nephrectomy and you can, you know, do a, uh you know, have a computer in a 3-D map out what part of the kidney is going to be resected and what part is not; versus you just taking a scissors and trying to actually cut it yourself, you know, and with your own just visual cues. And visual cues are fine, but I think that when it's automatic and done by a robot, I think that's pretty cool. So, in this, you are actually, again, finding the capsule, and you are not relying on internal visual cues when you are doing a TURP. And let's say you've got some bleeding and you are not quite sure exactly where the capsule is, well this has been predefined by a radiological exam, real time radiological examination of the area of the tissues that need to be resected away. So, like I said, I think this is, it's cool because it's, it is disruptive. It is a, in my opinion, a step forward for technology-wise because it allows, it takes away some of the human elements and actually uses actual patient individualized um markings. And um it's individualized for the patient's individual prostate.

LAURENCE CLARK, MD, FACP
Uh, so a great answer. Let me ask any of the other panelists if they want to add to that?

LINDA MEYER
Larry, if I may, um because we have so many members, um many of you have been introducing yourself before you speak. If each time you speak if you could, you know, say who is speaking, so we can have that for a record of who is on the call. I apologize.

LAURENCE CLARK, MD, FACP
And that was Dr. Jonathan Rubenstein.

LINDA MEYER
He did introduce. I should have said that earlier, so I apologize for stating that now. Thank you.

JONATHAN RUBENSTEIN, MD
No, thank you. And both, the last two comments were made by me, Jonathan Rubenstein. I have no conflicts.

LAURENCE CLARK, MD, FACP
Thank you, Jon.

ROBERT LURVEY, MD
This is Rob Lurvey, and hopefully -

JONATHAN RUBENSTEIN, MD
Go ahead, Rob.

ROBERT LURVEY, MD
Oh thanks. Uh I just was going to second what Dr. Rubenstein said, only to say it a little different. I think it changes the game, uh but uh like anything, the rules may change but the game is probably still just as hard um in that you go from visual cue to ultrasound-guided cue. I do think it is interesting, though, in the very large prostate they did in the WATER II trial, and I think that Desai, et al um from BJUI, and I think that was just published uh, I'd have to look at the dates here. Um but they note that the uh, you know, average number of cases per uh surgeon was four. I think, or the median was four and the uh, the average number of cases per surgeon in the trial was half a case. Um so certainly this is something that uh really reduces the learning curve for very large prostates. Uh whether that improves outcomes or makes it more accessible um to um other people to perform uh outside of maybe a large uh center or a large hospital, um I don't know.

LAURENCE CLARK, MD, FACP
Another great comment and appreciated. Oh, all right, um let me - go ahead.

JOEL FUNK, MD
Larry, It's Joel Funk, uh University of Arizona. And I too have no conflicts like Jonathan. Um I did want to make a couple of comments both on what he mentioned and what Rob mentioned. I think that, I think that Jonathan is correct that you know when we, particularly when we look at, you know, the traditional sized gland or a TURP, you know, in general probably that sub-80 cc gland, like in the WATER I trial, which is a good, good cutoff point and well-designed study to look at those size glands. Um you know, a traditional TURP tends to be uh a plumbing operation. You know, it's, uh you know, as he described, you are making a small tube bigger. Um it's not an anatomic procedure. And um, you know, I do think that that's one of the disruptive aspects of this technology is, is that when you are defining the extent of the the automated procedure with a live ultrasound, and truly are defining where that, you know, the true surgical capsule is, um you've taken it from a plumbing operation to an anatomic procedure. And as he alludes to, um you are essentially, you know, customizing what you need to remove to a particular patient that's in the operating room at that time. Um and that's, that has always been one of the arguments, you know, as a HoLAP practitioner um for large glands is that it is, you know, it's an anatomic procedure, it's an anatomic layer that is defining what we need to remove. So I do agree with him very much that, you know, it has the potential to be a disruptive technology, um and I think that the unanswered question, because a lot of this data, my criticism is is it's short term data in the greater scheme of things. But um if we extrapolate that anatomic approach to, you know, the sub-80 cc gland um I'm fairly confident that we'll see the same durability with, um with a technique that does an anatomic resection on small glands that we see with large glands that undergo an anatomic resection, which is a much lower reintervention rate in the future.

LAURENCE CLARK, MD, FACP
Great comments. Uh and if I could have just sort of jump a little bit out of line here, and because you opened the door to to a couple of the big questions and big issues that we wrestle with in the background here. I think my colleagues' concerns that led to the original position of complete non-coverage had to do with durability issues and with lack of maturity, if you want to use a general comment, of the evidence. Can you and fellow panelists talk about are we there yet? And what makes you think that now the evidence is there? Is it now the ongoing WATER trial which I think is Gilling, I think that's the big one that everybody talks about? Um do you also feel, I think Rob had said this to me in suggesting an article, is there a target size of gland where this technology is evolving to be superior to the others? I mean I hope you think these are reasonable questions, and if not, correct me. But um I think you opened the door to those really key questions, so you know please go ahead and um just work on it together, if you would.

JOEL FUNK, MD
Yeah, it's Joel here. I'll just jump in first. I think that um, you know, I think that my gut reply as a clinician is, is I think that we are nearing the cusp of durability. Um you know, in my mind if we are, if we are showing three to five-year um similar efficacy, you know, if we look at the analogs of, you know, Rezum or UroLift, that's pretty comparable durability for coverage. Um and uh in reference to your second point, the question of gland size, it kind of goes back to Rob's point that um, uh you know, for the smaller glands, the let's say the glands that are too small to HoLAP, and Rob and I have had those conversations before. Um uh I fall back on the statement of it's an anatomic resection, which you are not going to have with any other modality. And if we look at those large glands that may be best served by a HoLAP or an open prostatectomy, or a robotic simple, um I think that you go to that question of learning curve. Um you know, uh certainly 120 or 150 cc prostate where you can define your resection based on an ultrasound, uh and then automate it, um the learning curve there is as evidenced in, you know, in WATER II, significantly shorter than we are going to see even with a robotic simple. It may be 12 to 15 cases for an experienced robotic surgeon, or uh 25 to 45, maybe even 50 cases for someone adopting HoLAP. So, um I think that that goes to Rob's point is is that it may expand access and management to those large gland patients, uh outside of um you know centers of excellence. So that, you know, a patient may not have to travel two, three or four hours um to receive the ideal procedure, because they could um receive something like uh, you know, Aquablation locally. And I'll stop talking there, because I've been talking too much.

JONATHAN RUBENSTEIN, MD
No, Joel, It's Jonathan Rubenstein, your comments your comments are great. Every single one of your comments is, is uh very important in helping everyone learn, um you know, how this technology works and about BPH. But no, please, please keep talking. You are doing a great job. It's Jonathan Rubenstein, again. I was just going to sort of piggyback on that. You know, just as Joel was saying, you know, HoLAP is a, is an excellent procedure but it does have a learning curve that's associated with this. Um you know, this I think is like HoLAP going to be less invasive and more tolerable on a patient compared to like a laparoscopic or open simple prostatectomy for the larger gland. And it's a really nice option rather than somebody getting, let's say, either an inadequate PVP green light laser, uh somebody who isn't experienced in doing HoLAP, um and who doesn't want the morbidity of an open prostatectomy. Um I think especially for patients with a somewhat larger gland size, with a shorter learning curve and it is, it would be available probably to more people, and more people would be able to benefit from that, just like as Joel was saying, in a local area. You know, on a quick side note, one of the criticisms have about, you know, someone talked about oh what about the, uh you know, retreatment rate. You know, in I think it was WATER I or WATER II, you know, the retreatment rate was a little bit higher than TURP. You know, these were some of the first ever Aquablations performed in the United States, obviously people's first experience; and was going head to head against people that probably had been doing hundreds or thousands of TURPS during their lifetime. So, I think it's sort of a little bit of an unfair comparison about somebody with initial experience versus somebody who is very experienced. So just if it comes to retreatment rates, early on I would imagine the retreatment rates would go down with more experience, and the learning curve being very short.

JOEL FUNK, MD
I agree. It's Joel again. I agree 100% that with that we are not comparing apples to apples, we are, we are comparing people who have significant expertise in one surgical modality to another modality that is, that is new to them. And for that reason alone, I think that when you look at retreatment rate, I think you have to ignore retreatment rate. Um and I do also think that you have to, you know, even in comparing WATER I to WATER II, if you look at complications and management of those. You know, one of, one of the discussions that I have with other HoLAP practitioners is always the concern about postoperative bleeding and transfusion in both WATER I and WATER II. Um and I think that there's we see an evolution in regards to management and prevention of that postoperative hemorrhage. Um so again, I think that we are at this, I feel like we are at this place, where it's an odd place where we've got data that is semi-mature, semi-long term, yet we're also that's data that is compiled in essentially not so much a learning curve but an understanding of how to optimize the perioperative care of these patients. And uh, and I think that we'll see both of those continue to evolve, both the retreatment rate and um postoperative hemorrhage.

LAURENCE CLARK, MD, FACP
Thank you.

ROBERT LURVEY, MD
This is uh Rob Lurvey. I can just jump on one more thing here, which is um the idea of the procedure itself um, it seems that we talk about this with the HoLAPs too, in the learning curve everyone who is a urologist mostly knows how to do a TURP. And it seems that at least in WATER I, that was their outlet for controlling bleeding is to basically go in with the Aquablation and then uh a few times it seemed that a couple of practitioners, surgeons, ended up doing button vaporization or some type of electrocautery. So, um I would say that probably uh it's not uh necessarily greatly novel from the procedural point of view at the end of the case that you, you'll use your ultrasound to start that resection. Um as people get better at the ultrasound and understanding those planes, we are going to get better and better results. Um but as people may be on a learning curve, um it's you are already setup to do what you know, and to fall back on that. Now from a payer perspective, I guess the question would be how would that be defined um for you if someone broke out their, you know, electrovaporization.

LANE CHILDS, MD
Dr. Lane Childs here. Can you hear me?

LAURENCE CLARK, MD, FACP
Yes, we can. And thank you.

LANE CHILDS, MD
Great. My phone has been giving me a little fit here. Just a couple of comments on past things that were mentioned. I mean I, I agree with Dr. Rubenstein's ideas about the uh, you know, apples to apples and oranges and whatnot. There is no doubt that this technology has its own learning curve, but it definitely is different. Um and part of the beauty of that is, you know, the robotics and the application of that. So, I, you know, and you could look at people choosing procedures for patients, um you know, hopefully people are doing things which they are comfortable with. And sometimes there are patients that come along, especially in, you know, less served areas and more rural areas and whatnot that have needs for, you know, a certain amount of procedure that that individual might not either have the, you know, capacity to do, the technology to do, or the knowledge or, you know, experience to do. And this may be one of those equalizing factors, to try to help that. So, I think that point is actually interesting. Um you know, certainly it doesn't mean that every little nook and cranny urology shop in the country is going to be able to have and afford, you know, Aquablation services available. But just the idea of making, you know, what we think is a good technology available to a wider group of practitioners is actually pretty, pretty interesting. Um the idea Dr. Lurvey is talking about with, you know, comparing in the WATER trials, there certainly are some very experienced resectionists working. And to compare retreatment rates immediately, I agree that that's really probably not a very fair comparison. Yet that said, the results are pretty impressively similar in that, especially when you take into consideration the size of these glands. I mean I'm still astounded by the results of those two studies in particular. When I compare and think of what the average TURP is that I do, and how large those glands are, and what I feel like after I've resected, you know, 40 grams of tissue or 50 grams of tissue. When they start having mean gland sizes with triple digits it's amazing that they can have that kind of results anywhere near that. So, it's that to me is what's extremely impressive. Um I think that's pretty uh, you know, goes without saying that that is a game changer potentially in this particular field of BPH management.

LAURENCE CLARK, MD, FACP
Lane, while you are on, and first of all, would you um, I believe you have participated in some trials. You have actually used some of the, I think all of you have some direct familiarity with this technology. But would you identify any conflict of interest? And then I have a couple of questions for you. If your phone is now secure, I'm going to pick on you for a little bit, if that's okay. So, if you'd just give your um, yeah, any conflicts?

LANE CHILDS, MD
Yeah, thanks. Well I have no conflicts. Uh I am Dr. Lane Childs. I am in Salt Lake City, Utah. I've been a member of the Coding and Reimbursement uh Committee for the AUA now for over 20 years and currently serve as the National Insurance Advisory Work Group Chair, uh which is a work group that looks especially for payment policies and economic issues related to some of the procedures that come to us for uh AUA evaluations. So, it's been a real pleasure to be able to help out with those kind of services. And Dr. Clark was uh involved in a National Insurance Committee Meeting that we were, we held just this past week and it was a pleasure to get to at least hear him. I unfortunately could not attend in person due to a Achilles tendon injury, which I'm nursing along. But nevertheless, that's been my evaluation, or been my participation in this so far. I have no conflict of interest with it. I certain have done uh you know training and that kind of thing with the uh system. So, go ahead and you can quiz away, Dr. Clark.

LAURENCE CLARK, MD, FACP
I am just trying to be fair actually. I tried to look back at the work because there is an antecedent policy that you were aware of at that meeting that um several other fellow contractors had put out an earlier policy that defined complete noncoverage. And I think it was a general lack of maturity of the evidence, but two things that stuck out, and then I'll get you some help from your colleagues. But two questions. How do you rank the evidence regarding the large prostate? Because you just brought that up, that you find, I thought you found it to be remarkably useful in that population. How do you weigh that evidence?

LANE CHILDS, MD
Yeah, I personally give that a lot of weight. To me that is, to me that is probably the most uh significant factor in my evaluation of a patient that I think would be appropriate for this technology. I don't know that I know yet, maybe others can chime in their opinions, but is this technology going to be so much faster and safer and efficient and durable? You know all the key things we want to know, that it can be applied to all prostates across the board. And you know just make it almost cookie cutter simple. Because when I think of how my TURPs go, my TURPs do great; I'm proud of my TURPs. I have a lot of urologists that send me TURPs to do, and I'm proud of that. I mean it's kind of what I do. I mean I don't do robotic prostatectomies, I send them to my partners that are young guys that have learned it, and they have they have surmounted the learning curves, and they have phenomenal results. It's silly for me to try to do it. So, you know we kind of trade and do what we are good at. TURPs are a thing that, you know, everyone sort of anticipates and expects that all urologists do well, but I don't think that's true. And I think, I mean I've been in practice for 28 years. I grew up in the TURP world. Um I don't know that, you know, how many TURPs, you know, residents who come out of training right now how many they do. But I have done a ton of them, and when I think do I want to apply this Aquablation technology to, you know, every gland I don't know that I can beat how well I do with my TURPs, because those guys do great. So, I'm personally not out there trying to shove this technology down every TURPs throat, shall we say. To me where it's got, I think, a very profound advantage is going to be in those large glands, Dr. Clark. I think that's where it's going to be really potentially outstanding if we can make certain it's safe and, you know, properly applied. So how I weigh that is number one. I mean as I'm keeping track of a list of my patients that come through my office that I think are potentially good candidates for, you know, something, the guys with the big glands, that I verify have the big glands are the guys that go on the Aquablation list. And so, to me that's absolutely the number one thing.

LAURENCE CLARK, MD, FACP
Super. Let me then just go on to, unless anybody else on the panel want to add to that one?

JOEL FUNK, MD
It's Joel Funk here. As a big gland guy, I mean I'm kind of at the opposite end of the spectrum. You know, I don't remember the last sub-80 cc gland that I saw. Um and and similar practice patterns in that, you know, I I don't see those patients because the patients come to me for enucleation. Um and so I think that, you know, in trying to wrap my head around how does this fit into the management, and how does gland size play a role, I kind of go back to my prior statement that I think that yes, I think that we all recognize that there is a learning curve associated with enucleation. Um and I think that if, if we can expand the availability of a endourologic management for those large glands, you know, not every place is going to be able to afford this technology. But if we can get this technology into the, you know, the medium-sized and smaller, you know, 60,000 - 100,000 population metropolitan areas I think that a lot more patients will be able to be treated locally with that 100 cc gland as opposed to, you know, traveling, you know, four to six hours to see someone who can do enucleation. Um so I agree that that um, the appeal really is for expansion of uh local as opposed to regional management for those large glands.

Now the other side of that coin is is that, is the durability and safety question. Um you know, I think that those are very much unanswered questions. When we when we look at the WATER trials and we look at, you know, the initial reports I mean we are talking data that is essentially less than four years old. Um and I think that there is a very high bar already set by enucleation in regards to safety profile, you know, going on 20 years. And that does give me some pause that, you know, are we really, again, to use Jonathan's analogy, are we really comparing apples to apples? Um so I admit I am somewhat conflicted around that topic.

LAURENCE CLARK, MD, FACP
Thank you. All right, well, you know, again you brought something up and maybe I will pass the picking onto you, if it's okay, and again your colleagues can help you out. If you really look at WATER II, which um I think it was multi-centered, uh 100, 101 men, I think it really focused on the 80 to 150 cc prostate, or ml prostate. Um there was no comparative arm, it was kind of an open enrollment. I mean I think you would agree, honestly, that it was really not a randomized. It wasn't a gold standard trial. Um I think you would put it down at the low-quality evidence. And yet it seems to be sort of whenever you get into these conversations, and I've had an opportunity to speak to a couple of you in advance, just to kind of make sure I had, I was on the right track, um how do you respond to that? I mean I think that is the fundamental difference, and why we are asking you for help here is sort of, you know, we can go down the line on this. Is this the point for us to um, for Noridian to reopen this discussion by taking on a policy that defines limited coverage rather than uh complete noncoverage? And I know that's a difficult one, that's the policy one that, you know, we have to deliberate on, as medical directors. And I know Dr. Lurvey, and you heard one of my colleagues from Novitas who has been very interested in this field, you know, listening in and talking and talking with each other. Um if you were to offer an opinion at this point on the state of the literature, and I'll even throw out there, there is one thing that concerns me, the NICE paper, the European Consortium, talked about special considerations. And I believe Dr. Funk and Dr. Lurvey have already mentioned postoperative, postprocedural bleeding. Um you know, are we at a point where we should be relooking at some limited coverage? And if you could guide us in that direction please do so. I mean maybe this is the $60,000 question, or whatever it is. So, Rob, if you want to start, Lane, Joel, we will just work down the line. Rob, how do you feel about that?

ROBERT LURVEY, MD
Sure. Um well, that's really the $60 million question, um because that's what this boils out to, isn't it? Um so I break it down like this, um the goal of any uh prostate/bladder outlet surgery is to open up a channel. Um however you open it up, you open it up. This happens to use a jet of water, uh does it fulfill that purpose? It does. So, if the question is does it do the surgery it claims to do? It does. Um there are particular uh aspects of it that make it uh perhaps conceptually more dangerous. Uh I noticed in the NICE paper they discussed with their physician specialist panel um some, though they did not occur, theoretical or hypothetical um adverse outcomes such as what if you set the ultrasound in the wrong place? There is nothing to keep you from doing that if you don't know how to read an ultrasound. Um there is uh, there is more bleeding because, you know, if you don't get down to capsule, which this does not automatically do, and again, you don't set your ultrasound properly, uh then you have open venous sinuses or open arterial vessels. Um so these I think are the disadvantages that increase risk, but as we discussed there are also advantages, which is that if you do know how to read an ultrasound properly, um you can define anatomy that you could protect better with this than you could possibly with a standard TURP. And so, the question is, uh should Noridian consider a reopen discussion of uh covering it? The answer is it might be worth reopening considering for limited coverage if the question Noridian asks about coverage is does it serve its purpose? And uh on balance is it uh offering as many benefits as risks? But there is no, there is no great red flag that says this is not going to do what it promises to do, which is open up a channel. And in this case, there is no greater, you know, unforeseen risk than there would be in any other type of procedure uh that opens up a channel. And again, personal opinion.

LAURENCE CLARK, MD, FACP
Great, thank you. Lane, you are next.

LANE CHILDS, MD
Rob, Lane Childs. Yeah, well I would agree with everything that Rob just said. The one, the one thing though that I think the biggest uh cat in the bag is bleeding. I think that's the biggest issue to be, you know, that anyone has concern about. Uh it opens it, I think it's fast, I think people can learn it fast, I mean all of these kind of things are good; but um, you know, making certain that hemostasis is satisfactory is is the question. And as I, you know, consider that question in some of these patients with big glands, you know, you used the terminology, Dr. Clark, about, you know, quality of the study and talking about it being, you know, randomized and that. Well, you know, what we, unfortunately we still don't need another randomized study, what we need is a focused, biased study. We need to treat a bunch of guys with huge prostates and see what the hemostasis is, you know. And if you want to I guess throw in a randomized arm of TURPs and, you know, of HoLAPs and all of that, I mean, you know, that could be worked out. But to me, as Dr. Lurvey has said, it is answering the question. And so, some kind of limited coverage I think the answer is yes. But I think it's with an eye of being cautious with this whole hemostasis question, because at the end of the day everything about this issue, that's the one issue that in my mind is still, I'm still gaining comfort levels with it shall we say. Um and I think experience and time is what, what you know, helps helps that be overcome. Um and how do you get there? Again, it's the chicken and the egg thing that we were talking a little bit about on Friday. You know, procedures and these kind of experiences and numbers don't build up if there is no coverage base. It's very difficult to do. So how that gets started is the question. And that's always been a difficult thing for any new technology.

LAURENCE CLARK, MD, FACP
Thank you. And Dr. Joel Funk?

JOEL FUNK, MD
Yeah. I agree with Lane uh wholeheartedly that um, you know, Larry, to get back to your question, you know, is this something that needs to be looked at in regards to, you know, limited coverage? I think that my gut and interpretation is is yes. The question is, is that unlimited size? And I have the same pause, um you know, I think that we've mentioned it clearly, this is a potential tool for those large glands where enucleation is not available or a robotic simple is not available. Um but my concern centers around hemostasis. Um you know, the McGill Group just published, you know, we are looking at August articles in regards to Aquablation. You know, we can look at October articles in regards to the McGill Group 18-year experience with enucleation, and their transfusion rate was under 1%. Um and uh, you know, I think that both from a medical standpoint we all know the need for transfusion is a profound increase in risk for a particular patient. And I think conceptually for patients that's always one of the um, you know, one of their pauses is, is do I need, is there a potential chance that I'm going to need a blood transfusion? And you know I can say confidently to patients, no, you are not going to need a blood transfusion with HoLAP, you know, the vast majority, you know, 99.2% of the time. Um and when we have, when we look at WATER II, we are looking at a very select group of large prostates um that essentially hemostasis is tamponade. You know there is no, there is no hemostasis mechanism built into the system, you know. And I know that Peter in the initial prototype series looked at using a laser, and WATER I looked at using some, you know, spot coagulation. Um but I think that Lane is 100% correct that until we have a whole bunch of cases done, and maybe there is a control arm that's a combination of robotic, simple and HoLAP, um I have pause about whether this is something that really can meet that, that high bar of safety.

LAURENCE CLARK, MD, FACP
Thank you. Uh that's a great opinion and a thoughtful one, and Jonathan?

JONATHAN RUBENSTEIN, MD
Yep. So, yeah, Jonathan Rubenstein again. Um you know, it's one of those things that uh sometimes the market market figures it out. I mean if the technology pans out, and it's good technology, people are going to use it, and people are going to want it if patients do well. If patients don't do well the market is going to phase it out, and that's just how it works. If people don't get good outcomes, don't get long term, you know, long term outcomes, there is bleeding issues that go on they are going to look, doctors are going to look for something else and patients are going to look for something else. I want to say the hope and the possibility of the right patient selection and the right procedure done by uh, by opening it up, I think there are advantages in certain, you know, certain situations on certain patients. You've got a patient with a gland that's large enough that they will probably get an inadequate laser therapy, or may need two or three of them over their lifetime, versus the possibility that this gland is large enough you get one Aquablation it might last you 25 years, or maybe longer, because of the completeness of the resection if done appropriately. I just think the hope and the potential is there, and yes, I do understand there just is two-year outcome. Um but you know you can sort of extrapolate that out, it's pretty good two-year outcome. Um but again, if there is coverage and if people do well, it will fly. If there is coverage and people don't do well and long term it doesn't pan out, people aren't going to use it.

LANE CHILDS, MD
Yeah. Hey, Dr. Lane Childs here again. Uh Jonathan, I agree. You know, market, surgeons we are all victims of our last three cases. You can have had a lot of success doing whatever, and if all of a sudden for whatever serendipitous reasons the last three people, you know, it went south for some reason, you are not real excited to ramp up and do the fourth guy. And you know, if you had a significant hemostasis issue over and over and over again, uh word gets out, the surgeon won't do it, patients find out. I mean I couldn't agree more that market forces are very powerful. And uh they help guide and direct part of what happens. But uh, you know, like Chin was saying that we've got to, you know, have a large N. It just takes a lot of people to, I think, get comfort in knowing exactly what, uh what performance level this can achieve and what it cannot. And I mean these are I think very good starts on these, on these papers and time would improve that over the experience.

LAURENCE CLARK, MD, FACP
If we had weighted. Okay, Sunil?

SUNIL LALA, MD
Thank you so much. Uh I'm the Medical Director with the uh systematic company, Novitas Solutions, and Larry was kind enough to invite me to listen in on this discussion, and I thank you for that. And I am a surgeon by trade as well, so we get the concept that everything works well until it doesn't. Uh I believe someone alluded to four-year data, uh but then Jonathan alluded to two-year data. I'm aware of the two-year data for WATER II. Do we have an anticipated data publication for uh WATER uh II at three-year data?

JONATHAN RUBENSTEIN, MD
It's Jonathan Rubenstein. I do not know any um, I have not heard anything. I have never asked the question, but I don't know of any particular um time if or when that data may be released.

LANE CHILDS, MD
Yeah, Dr. Childs here. I also am not certain of what the status is of ongoing data collection and reporting.

LAURENCE CLARK, MD, FACP
I was going to ask a question and just, just to think about if anybody wants to opine on this one. If we were to uniformly as contractors wait until three years uh for literature kind of across the board, would we be making the world easier for people?

ROBERT LURVEY, MD
Rob Lurvey here. So, you - go ahead.

UNIDENTIFIED CAC MEMBER
No, please, go ahead.

ROBERT LURVEY, MD
Well, I was going to ask is your question then, Larry, whether the extra year of data is going to make us make a bigger decision or change our minds?

LAURENCE CLARK, MD, FACP
And not just in the context here, it's in the context of policymaking. If we have a defined expectation and, you know, this is really just kind of philosophical stuff. I'm going to get back down to the basic questions and wrap it up shortly because, you know, you guys have just been a real resource here. Um just you know would the world, would academics and industry like it better if we had a defined threshold for consideration? Would that make things easier?

JONATHAN RUBENSTEIN, MD
So, it's Jonathan Rubenstein here. You know it it it's a great question because it's come up at, you know, things like CPT in the past. You know my, my personal opinion is based upon the mechanism of how this uh, this device works, and how this procedure is performed. To me, that along with two-year data, has convinced me that I think it's worthwhile covering. And it's convinced me that this is a good option for patients, especially those patients who are not perfect candidates for a laser therapy or a lot, you know, well especially the UroLift and the steams, you know, because the prostates are just of a large size. I think patients would potentially really benefit from this over the more invasive, you know, laparoscopic simple prostatectomy. I just think that there is an advantage, more outpatient rather than, or at least overnight rather than such a big abdominal incision. And the two-year data in my mind has convinced me. There are probably some people that want to see three-year data. My personal opinion, Jonathan Rubenstein, I do not need to see three-year data. It would not help me out as a practicing urologist.

LANE CHILDS, MD
Yeah. So, Dr. Childs here. I would agree with that. I mean I feel the same way. I think the mechanism, the way it works and that kind of thing, I think it's, I truly do, and I don't use this word lightly, but I think this is a game changer for dealing with some prostate issues, for these big glands. And so, to me uh three-year versus two-year data is not the, is not the difference maker. Specifically, Dr. Clark, would it make it easier? It would actually make it more difficult, because the biggest issue I'm dealing with right now, out of the main hospital I work out of, we have gone back and forth in the hospital making a decision about whether to even trial, bring in this technology. And you know coverage and their analysis, their version of how they think the numbers work out have brought to their conclusion that they don't want to even bring it in. So, I'm stuck. You know, I'm in no-man's land right now. I don't even know if it said it was covered where I would do it right now. I'm kind of back to square one. But that's my personal problem in my practice locale. Um I think those type of decisions, however, make it that much more difficult for technology to go forward and be utilized. And then for the numbers to get up to a point where we start having more confidence in what results are reported. So, you know, from two versus three, I wouldn't, it wouldn't change my mind. And frankly, without coverage, it makes it almost undoable in my personal world anyhow.

LAURENCE CLARK, MD, FACP
That was a philosophic diversion. Anybody else on that?

JOEL FUNK, MD
Yeah, it's Joel here. Let me just riff on that and say that um two-year versus three-year, I don't think that it makes uh any difference really at all. I think that my question is what does the 10- and 15-year data look like? Um you know, I think that as we had at the outset of the discussion this is much more of an anatomic approach to uh, you know, benign prostatic obstruction. And several people have commented, and we've touched on the anatomic nature of it, the um defining your resection to the surgical capsule. I think that it's important that we also um recognize that we are treating, you know, 210 degrees of the gland, um we are not treating circumferentially with this technology. And so, does that, you know, does that other 150 degrees of anterior prostate um over time cause recurrent obstruction in the future? You know, the old teaching always was well there is not very much tissue up there and it doesn't cause obstruction. And you know, practicing HoLAP for more than a decade I can tell you that there is oftentimes a lot of tissue up there and um, you know, I think that that's a question that's not going to be answered at three years as opposed to two. So, um I don't think that that really changes the, my thought process, like Lane and Jonathan mentioned.

LAURENCE CLARK, MD, FACP
Super. Um coming back and starting to try and return you to your other responsibilities, I do want to say one thing, I had an approval process question, which Jonathan and the FDA helped me answer. I was interested in the fact that um, you know, how this device was FDA cleared in terms of the computer-defined area of resection, robotic execution, the concept of the Waterjet, etc. And it is, I learned, that it is a de novo device. It is essentially its own predicate. And it is, I think, defined as relatively low risk. So anyway, that question of mine was answered. I do share eight questions, which we are going to blow through really quickly. These are questions, in fairness to you, that were actually kind of used by colleagues in terms of, I think, working around to the noncoverage position. And I'm just trying to repeat them with your help and see whether or not there is a difference. I mean we do try to collaborate. You just heard that there is colleagues from other contractors listening in and seeing how we are handling this challenge of a new carrier advisory process. And then I'll wrap up with about a minute or two on, on where we go from here, and how we rate your recorded comments, which I am absolutely going to listen to again because I think this has been a really great discussion, and with a lot of depth. Considering, you know, that none of you has particular proprietary interest, many times we find a significant proprietary interest which we understand and mitigate for with the conflict of interest process. But to have folks like yourself who, who are devoid of that and yet have such, you know, kind of in-depth knowledge is really appreciated.

Anyway, this is a typical question with evidence analysis, with an evidence rating of 1 to 5 where 1 means the lack of evidence, uh lack of supporting evidence, and better evidence is likely to change your confidence; 3 is kind of better evidence could change your confidence; and 5 means there is strong evidence, further research is unlikely to change your confidence. And that was very interesting when I heard Joel's remarks about, you know, the 15 years, the real look back, you know. Anyway, we'll go in order, sort of the way we've been going with Rob first, Lane, then Joel, then Jonathan. And we'll just - I'm just going to blow through these. The first one is how would you rate the evidence on Waterjet technology in terms of reduction of lower urinary tract symptoms due to the BPH with prostates less than 80 grams? Rob.

ROBERT LURVEY, MD
I'd give it a 5. It reduces the lower urinary tract symptoms at the time of surgery.

LAURENCE CLARK, MD, FACP
Outstanding. Lane?

LANE CHILDS, MD
Yeah, I agree, I'd give it a 5.

LAURENCE CLARK, MD, FACP
Okay. Joel?

JOEL FUNK, MD
4.

LAURENCE CLARK, MD, FACP
4? Jonathan?

JONATHAN RUBENSTEIN, MD
Uh 5.

LAURENCE CLARK, MD, FACP
5. Okay, next question. Rate the evidence on Waterjet technology in terms of safety with prostates less than 80 grams? Rob?

ROBERT LURVEY, MD
I'd give it a 3, and it's not years of follow-up. I need to see more patients.

LAURENCE CLARK, MD, FACP
Super. Lane?

LANE CHILDS, MD
Yeah, I would agree wholeheartedly. That's exactly what I was going to think of there too. Good.

LAURENCE CLARK, MD, FACP
Got it. Joel?

JOEL FUNK, MD
3.

LAURENCE CLARK, MD, FACP
Okay. And Jonathan?

JONATHAN RUBENSTEIN, MD
I'll keep it 3 also.

LAURENCE CLARK, MD, FACP
Okay. Question 3, rate the evidence on Waterjet technology in terms of reduction of sexual side effects. Rob?

ROBERT LURVEY, MD
Probably a 4. I'd say 4, same idea, more patients.

LAURENCE CLARK, MD, FACP
Got it. Lane?

LANE CHILDS, MD
Yeah, I would agree, 4. I mean there is clearly a distinct advantage. You know, back at the beginning of this discussion uh Dr. Rubenstein was mentioning about, about details on bladder neck preservation and the anatomical change and stuff. It's, and that's when my phone was being a fuss here, so I was going to mention at that moment. You know, it's interesting to me that, I agree that that's what happens, but visually, and I know we have been taught with TURPs and all of these procedures that you sometimes cannot really base outcome and whatnot just on the visual uh appearance of the prostate and the outlet. Um man, those prostates certainly look like a lot of that tissue is missing post-Aquablation. It just doesn't look that different from some of the TURPs. And, and it doesn't really make perfect sense in my head that that's the mechanism of that sexual function preservation. Is it just the heat thing? Maybe. But honestly the answer about why is it different? We really don't know right now. I don't think we do. I think we have some good scientific guesses, but I don't really think we know. It's a nice surprise but nobody knows. So anyway 4 for this answer.

LAURENCE CLARK, MD, FACP
Super. Joel?

JOEL FUNK, MD
I agree with Lane, a 4. And I agree with his uh editorial on the mechanism of post-treatment ejaculatory preservation. We don't know.

LAURENCE CLARK, MD, FACP
And Jonathan?

JONATHAN RUBENSTEIN, MD
4.

LAURENCE CLARK, MD, FACP
Great. Okay, question number 4, is rate the evidence on retreatment needs with this technology. Rob?

ROBERT LURVEY, MD
Uh yeah, incidentally I think Tom Chi is on this call, but I think he's having some technical difficulties. Um I would say uh it's going to be a low 3. Um we just, that study is actually taking more time.

LAURENCE CLARK, MD, FACP
Okay, Lane?

LANE CHILDS, MD
Yes, I agree. I couldn't give it above a 3 either, just because it just takes more time for data to mature.

LAURENCE CLARK, MD, FACP
Okay. Joel?

JOEL FUNK, MD
I agree with the other two, a soft 3.

LAURENCE CLARK, MD, FACP
A soft 3. And Jonathan?

JONATHAN RUBENSTEIN, MD
3.

LAURENCE CLARK, MD, FACP
Okay. Tom, were you able to join us? And if not or if you are just listening you are going to have an opportunity to submit your thoughts in writing, and we'll work with you to get that. Okay, um question number 5. We are more than halfway there now. Rate the evidence on Waterjet technology being non-inferior to TURP. Rob?

ROBERT LURVEY, MD
Uh it's going to be a 4, only because non-inferior is loaded in terms of so many things. It certainly treats well and probably not any worse.

LAURENCE CLARK, MD, FACP
Okay, Lane?

LANE CHILDS, MD
Yeah, I would give it a 4. I would say a 4.

LAURENCE CLARK, MD, FACP
Okay. Joel?

JOEL FUNK, MD
Uh 3.

LAURENCE CLARK, MD, FACP
Okay. And Jonathan?

JONATHAN RUBENSTEIN, MD
4.

LAURENCE CLARK, MD, FACP
4. All right and we are onto question number 6, 6 of 8. Rate the evidence on Waterjet technology in terms of reduction of uh LUTS uh due to BPH with prostates greater than 80 grams. I'm interested in this. Rob?

ROBERT LURVEY, MD
Again, uh 4 from the uh Water II did show a reduction in uh the IPSS scores at the big glands, at least immediately after surgery.

LAURENCE CLARK, MD, FACP
Lane?

LANE CHILDS, MD
Yeah, the symptom comparison, I would give it a 4 as well.

LAURENCE CLARK, MD, FACP
Okay. Joel?

JOEL FUNK, MD
Uh 3 again.

LAURENCE CLARK, MD, FACP
3 again, okay. And Jonathan?

JONATHAN RUBENSTEIN, MD
Well, I'd say 5 for short term, 4 for long term. And I don't know if I can split it like that. But if I can, that would be my answer.

LAURENCE CLARK, MD, FACP
I'll take it because I mean we are not scoring here, we are trying to get your opinions and see if even time, maturity or familiarity with some of the newer literatures changing people's thinking. Um Question 7, rate the evidence on Waterjet technology in terms of safety for prostates 80 to 150 grams.

ROBERT LURVEY, MD
I'm going to actually say probably 2. I think uh 25 surgeons uh in the study, um if you count them up, uh I think that there is probably a lot more that can go wrong that we will learn about. And uh so I think more data will be helpful with more patients.

LAURENCE CLARK, MD, FACP
Lane?

LANE CHILDS, MD
Yeah, I would, I mean I'd give it a 3. I mean I think uh all considered for the variability and numbers of individuals involved I agree with his comment, but I would, I would give it at least a 3 though.

LAURENCE CLARK, MD, FACP
Okay, Joel?

JOEL FUNK, MD
I agree with Robert too.

LAURENCE CLARK, MD, FACP
Okay. And Jonathan?

JONATHAN RUBENSTEIN, MD
3.

LAURENCE CLARK, MD, FACP
Okay. And the last question, Uh rate the evidence on Waterjet technology compared to non-TURP procedures for prostates less than 80 grams. And this is another split answer, and then 80 to 150 grams. So, the evidence on Waterjet technology compared to non-TURP procedures for prostates less than 80 gram. And then 80 to 150 grams. So, I'll look for a split answer from each. Rob?

ROBERT LURVEY, MD
You are using communicative property here. To be clear, this is not a minimally invasive procedure. I think you asked that earlier. Um I would say that probably more evidence for both small and large glands will, will uh change an opinion. But otherwise I approach it as any other procedure.

LAURENCE CLARK, MD, FACP
Okay, so the evidence you would say?

ROBERT LURVEY, MD
I would say that the head to head comparison against TURP allows me to then extrapolate to other non-TURP procedures in the same way. Uh I routinely compare procedures uh in this field. Um it's always communicative.

LAURENCE CLARK, MD, FACP
So, you are declining to put it into a number?

ROBERT LURVEY, MD
Uh 3 for both.

LAURENCE CLARK, MD, FACP
3 for both?

LANE CHILDS, MD
Yeah, well, you know, I don't know how, I've read and I'm looking at that question here on the email you sent previously, you know anticipating this question. And I don't how else to give any other number besides about a 3 as well, because for certain things I feel better and for certain things I feel less confident. Um I mean, you know, in terms of its efficacy and, you know, speed and, you know, it's great. In terms of safety, I think the question is a little bit still out there to be uh answered, as we have already discussed. So, I mean I'm going to split the difference and say 3. I think there is good evidence, it could be better; but it definitely is accomplishing what its purpose is so far.

LAURENCE CLARK, MD, FACP
Okay, Joel?

JOEL FUNK, MD
Yeah, I guess I tend to be a little bit more dogmatic maybe than Rob. I mean, you know, in my mind there really, I don't think that I can fault extrapolation, you know when we say well TURP is equivalent to, you know, PVP, so therefore Aquablation should be equivalent to PVP. Um but there is really is no evidence. You know, there is no direct comparison trial. Um you know, so, you know, at best if we want to extrapolate other um non-massive modalities like PVP um, you know, I would say a 2. Um and for those large glands, you know, there isn't any data. Um and I think that that's an entirely different ball of wax. And unfortunately, you know, I think that that's probably a 2 as well, maybe a 1.

LAURENCE CLARK, MD, FACP
Okay, great. And Jonathan?

JONATHAN RUBENSTEIN, MD
3 and 3.

LAURENCE CLARK, MD, FACP
3 and 3, okay. I am going to just explain in two minutes what we do next, and if Tom can get on, please do, and if not, we'll make sure we get his comments in writing. Um and any, I do know some -

UNIDENTIFIED CAC MEMBER
Larry?

LAURENCE CLARK, MD, FACP
Yeah, yes.

CRAIG
That's correct. Yes, I am the Medical Director in JK, and my background is surgery as well. Can I just ask a few questions?

LAURENCE CLARK, MD, FACP
If you guys have the time, go right ahead.

CRAIG
Yeah. You said, just to sort of take it in order, you started out by saying that um we can change our opinion based on new data. You brought up that uh that one paper, that Roehrborn paper, which looks like a review. Was that a systematic review, or metaanalysis? I couldn't get the actual paper; it says review in its title, but I wanted to ask that.

LAURENCE CLARK, MD, FACP
I think it was a systematic review. Um Rob, I think you had mentioned looking at that. Can any of the four of you?

JOEL FUNK, MD
Yeah, let me pull it up. I don't think that I've got it up in front, it's not really, it's not a rigorous systematic review. The only really rigorous systematic review that I'm aware of was um actually is newer, um was published in September um by another group, um where they actually looked at all the published literature in regards to Aquablation. That's uh, it looks like it's uh, I'm not familiar with the uh authors myself, but there was a, there was a systematic review in September from World Journal of Urology. Now take that with a grain of salt that this was an invited review, um but um they, they systematically look through all of the um, you know, the randomized trials, kind of the Level I evidence. And that's actually a little bit newer than Clause's article. Um but that might be something worthwhile pulling, Larry, to look at. And I will say that I actually have to drop off the call, because I have uh an appointment myself uh here in about ten minutes. So, if there is anything else critical that we need to go over, um I've got about two minutes before I've got to go.

LAURENCE CLARK, MD, FACP
Um I don't, I thank you for the time you've taken and the work you've done even prior to today. So uh, thank you and, you know, please get onto what you need to do. And then, Craig, if you have the other questions we'll go on to the rest of the panel.

CRAIG
Hey Larry.

LAURENCE CLARK, MD, FACP
Go ahead, Craig. If the remaining panelists can handle it, go ahead.

CRAIG
Larry, I keep getting muted.

LAURENCE CLARK, MD, FACP
Okay, you are on now?

CRAIG
Right. I keep getting muted over and over though, so hopefully it won't happen again. It was hard to get back enough to even say anything to you. So, I missed a lot of that because also when it's saying I'm being muted and un-muting it, I can't hear what is being said. So, um my point there was that, you know, if it's just a review and not a regular systematic it really doesn't add to the body of data. Um, so that was one point. I did hear that there may be another one out there, World Journal of Surgery, um so I'd have to look into that. But the um, there was some discussion about the durability information which we know sometimes isn't available until over three years, even five years or more. But we didn't mention the specifics about that. The one year showed the Aquablation uh having the surgical, the operation at 2% versus 1.5 for TURP, and at two years it was actually worse, it was up to 4.3 versus 1.5. So, the trend there is getting worse so, you know, from my perspective it definitely makes sense. I mean I have a bias towards waiting for real midterm data, which would be three-year data, anyway but especially in the setting of uh two-year data that seems to be trending in a bad direction. You know, I heard this conversation about why that should be discounted, but that's the data. Um you know, and that's what we should go on, I think. The um, let me see what else?

ROBERT LURVEY, MD
I could jump in your review question. Um so that particular review that's mentioned is an overview, that's not a systematic review in that Roehrborn paper. Um the papers that have, this is Rob Lurvey, the papers that have sort of the robust data is going to be that randomized control trial through the WATER I and WATER II. Um there is the side paper from BJU International. And that I can't speak for Dr. Child's or Rubenstein or Joel now, uh but that's where I would uh derive most of my confidence in the uh reliability of the procedure and just an understanding of, you know, the general nature of what it does and what we are talking about here in terms of just opening a channel.

JONATHAN RUBENSTEIN
This is Jonathan Rubenstein. I just want to make a couple of comments about the reoperation rate. First of all, you are talking about like 170 patients, and so the reoperation you are looking like, it was like three or five patients. You know, it's really hard to extrapolate much else. And so, I know that you said the percentages were higher, but these are, these are very few patients um overall. And if you actually, if I remember correctly, if you extrapolate to the large glands there was a 0% reoperation rate in people with glands between 80 and 150 grams if I remember correctly, which would be lower than TURP uh even at a certain amount of time out. So, it's hard to use a percentage, let's look at actual numbers, it was like four or five. And these are the first ever Aquablations that were performed in the United States of America, compared to people that have done thousands of TURPs. So, you can't really compare apples to oranges there. So, let's, I just want to make sure that we understand what that number, not the percentage but let's just look at what that actually means.

CRAIG
Yeah, no, I understand and I, you know, hear the apple to oranges argument earlier. And like I said, I understand that; but we just should take, take that into account and recognize that that's the data. Um the other thing I was going to mention, there was a discussion about the two-year data and people were talking about applying that. It seemed like the large glands, but the two-year data is specifically to normal size glands, there is only one-year data and that's uncontrolled uh on the large glands. So, I just wanted to make that point that, you know, you can't necessarily I don't think use the two year uh regular size gland data to apply to the large glands. Um the, as far as the mechanism for decreased sexual dysfunction, um I don't think we can take it to the bank yet that there is a real difference between the two in sexual dysfunction. So, while we can talk about mechanism, I think that there is still questions about whether there is a real difference because there are several layers of potential bias in the original study. So, I just want to make that point. And also, Larry, I just wanted to ask you, I thought that the panel was going to be balanced in terms of um for and against, but I didn't hear a whole lot of balance.

LAURENCE CLARK, MD, FACP
Um I think that the panel was balanced in terms of not having conflicts of interest and being selected without, you know, my prior knowledge of their positions in terms of who was brought on. So, you know, we were devoid of proprietary experts, um and I actually did not know any of their prior opinions. As I said, I did learn something about Rob actually sort of coming around to some of these opinions um as we talked them through. So um, you know, I think we also have a number of other urologists from our states on the line, but we couldn't process and accommodate everybody. So, I'm hoping to have additional written comments from our urologic constituents speaking as Noridian uh following today's call.

CRAIG
Okay, thanks. That's all I had.

LAURENCE CLARK, MD, FACP
Well thank you. Again, so, you know, I think this is great to show that, you know, colleagues from other contractors, we are trying to have an element of collaboration and consistency in what we are doing. So -

JONATHAN RUBENSTEIN, MD
Dr. Clark, this is Jonathan Rubenstein, can I make one more quick comment?

LAURENCE CLARK, MD, FACP
Absolutely. In fact, I'm going to go down the line for the remaining folks, so go right ahead.

JONATHAN RUBENSTEIN, MD
Good. So, I think it ultimately comes down to this, as a practicing physician, and I want to take good care of my individual patients who have individual needs, individual, you know, individual health and what is the best for them. Based upon the data that currently exists, I would have no concerns in not only offering this to my patients. But I think I have a lot of patients that would benefit from having this technology available to them because in certain patients, whether it's the size gland, whether it's their health, what needs to be done I think that this potentially confers significant advantage to an actual human being over some of our current technologies, especially in glands that are larger than 80 glands that aren't going to do well with the UroLift, or the Rezum, or even a laser is incomplete. So, would I offer this to my patients it were available to me? Absolutely, without hesitation. So, I just want to make sure you understand that. We can talk about the nuances and the large size gland and the small size gland and the percentages and the numbers and the learning curve, da, da, da; but ultimately I think it's an advantage to the patients, uh both non-Medicare and Medicare patients, in the properly, in patients who are actually who I see, who I treat as a practicing physician. Thanks.

LAURENCE CLARK, MD, FACP
Thank you. Lane?

LANE CHILDS, MD
Yeah, I mean I could not agree more wholeheartedly. If I am able to offer, if I have some man come into my office who's got a, you know, 200 cc prostate, you know, it's I could take him and do TURPs on him over three or four times and finally get it out and it would still be incomplete. And it would be unfair to him when there is technology which exists that could take care of it in a matter of minutes. And that's literally what this can do. His alternative is to have one of my, is to have me do an open incision suprapubic prostatectomy, which, you know, for years has been, frankly, one of the my favorite operations to do. It's really fun to do that operation, guys. Let's face it, I love doing that case. I never do that case anymore because my robotic partners can do it, you know, that way but they are still in the hospital, it's a big deal to go through all of that. And you compare that to this potential technology, Dr. Rubenstein said it perfectly, of course you want to offer this to them. With these kind of numbers the nuances, the details, the reoperation, yada, yada, yada, that's going to, I think it's still going to fall far into the safe I choose that approach rather than I have hesitation. So totally I agree 100% with what he said.

LAURENCE CLARK, MD, FACP
Lane, can I ask one question here? Are most of these cases done under general anesthesia and therefore technically not a minimally invasive procedure? Would that be a fair statement?

LANE CHILDS, MD
Absolutely. That would be a fair statement. I would not consider this a minimally invasive procedure. I just would not, even though it's quick and whatnot, you have to have anesthesia. So uh, you know when we think of these missed sort of things, a UroLift or some, you know, smaller thing in the office uh, this is an operation. It's uh, I think to characterize it as a minimally invasive is misleading and not fair nomenclature for this procedure.

LAURENCE CLARK, MD, FACP
Okay, thank you. And Rob? Thank you in getting this together and you get the last word.

ROBERT LURVEY, MD
Yeah. Thank you. I think as I get the last word here I should probably uh just balance some points. Um the first is yes, with the large glands we have short term data and that was misconstrued. I apologize. Um I will uh go a different direction from Dr. Childs and Dr. Rubenstein on the question that was presented at the end of this, which is would you give this to your patient? Previously, the question presented was is this non-inferior to TURP? The answer is, it is not, it is not inferior. Um but uh I would probably not offer this to my patients. I do do HoLAPs and I do have colleagues uncomfortable with doing robotic simples, and for very large glands uh I think that the benefits that we've previously spoken of are outweighed by the risks we've previously spoken of, plus uh elements of uh OR time and setup. So, I think at this point I would not offer this uh to my patients, uh in any strong way. If they came to me, I would not say no, but I don't think I would offer this. You currently do cover alternatives uh for what this treats. Um where the value is here, and I think we all agree, is that there is a role um that's very practitioner-dependent and gland-dependent, and that may be its room. Um and again thanks for letting us contribute and offer our opinion as providers uh to give data sets that you as medical directors can decide how to proceed.

LAURENCE CLARK, MD, FACP
Super. And thank you for uh helping engineer this. Let me say a couple of things what I'm going to do. Um some of my Noridian colleagues are at a conflicting meeting. We are actually going to listen to this, and I thank you for the brevity and conciseness of the comments too. And, you know, hopefully we are on target. Um you know, this is not a single person decision, we will talk about um where do we um, do we write a draft policy, do we um adopt existing policies? You know, what is our direction here in terms of the literature? And um if we decide to um, to develop a draft we will certainly let you know. And I ask all of the uh, the colleagues on the phone and particularly urologic colleagues, we couldn't get everybody on but that doesn't mean we don't value your opinions. And that's why I know Dr. Art Lurvey uh talked at Western State Urology. I think we have a number of you on the call today. Even if it's in an email, please look at our website or when Linda concludes the meeting. You know we will tell you how to get those comments to us, and we'll think about it; um but really I appreciate the panel in distilling the issues, and we will look at um what was said today and decide whether or not um to um proceed with a formal draft. So that being said, also please anybody wants to send in uh comments about this carrier advisory process. Did you feel like we covered the issues well? Were our key questions good? Um please just let us know how we are doing interpreting the new law and the new process. And with that, I thank everybody. Linda, if you want to wrap it up?

LINDA MEYER
Thanks, Dr. Clark. Yes, as um Dr. Clark says, first and foremost, we want to thank all of our CAC members. Um as this is one of our first formal CAC members under the new process, you've seen that there is a lot of effort that goes into it, and uh we've been making notes on how to improve upon it for going forward. Uh the discussion was phenomenal and we have um documented in addition to this meeting being recorded, and it will be posted to our website um approximately 30 to 45 days after today's meeting so that you can go back and listen if you want to hear. Or if there were colleagues not able to attend, this will be available to the public to hear and to share with um your former colleagues, or fellow colleagues. Additionally, as Larry talked about, the next process would be um potentially a draft policy that is generally notified through our list serve, and also published on our website. Um we are working to better communicate that um with banners and different types of information so that you are made aware when our, our draft comment period begins. Most importantly, we will have an open meeting for you to verbally share any comments on that. But the key to any um policy development is the written comments so that we can formally address those, and um properly provide a response to any comments. As uh Dr. Clark said, we are working through this new process. We've learned a lot and again, want to thank those who were in attendance, those who shared their comments um externally. And um most importantly, like I said, the CAC members there is a lot of information that goes into um their preparing for this meeting, and so we do thank them for their time. Um We do have some comments. If you have comments on this process um, we will allow them to be submitted to our email address. That comes directly to our policy team and that email address is policyb@Noridian.com. Although it says policy b, we will accept anything uh for the AB medical policy that we are in process of considering. Um again, thank you all for your time and um safe travels if anyone is traveling um today. Thank you for your time.