MoIDX Open Public Meeting - September 09, 2019 - JE Part B

DR. GARY OAKES:
Welcome to our Open meeting on this rainy September 9th evening, it is not snowing, that is a plus. It is Fargo, and it is still windy, so you know you are in the right place. Today we have a couple of policies to go through and we have seven presenters as I understand it and that will be approximately seventeen minutes each, and without much further adieu, we have Dr. Eileen Moynihan on the phone and she is more familiar with these policies than I am. So, Dr. Moynihan, do you want to take it away? And Christine will do the clicking for you.

DR. EILEEN MOYNIHAN:
O.K., Great - I hope everyone can hear me. 

DR. GARY OAKES:
We can hear you fine.

DR. EILEEN MOYNIHAN:
I am Dr. Eileen Moynihan, and I have primary responsibility for the two policies that are going to be discussed in this open meeting.  As Dr. Oakes mentioned, we have seven presenters between the two and I would like to remind everyone, that if you have comments, we need to have them in writing.

We have a few attendees from Noridian. Dr. Oakes and I, and I know Christine Burnside and Lynda Feir are with us on this project and I don’t know if there is anyone else in the room.

CHRISTINE BURNSIDE
Yes, Dr. Moynihan - Jocelyn Fernandez, and MPS is in the room and Rachel Broer is in the room and Dr. Arthur Lurvey is in the room. I could not forget Dr. Arthur Lurvey.

DR. EILEEN MOYNIHAN:
Yes, don’t do that, that would not be good.

O.K. A couple of reminders - Don’t put your line on hold, if you need to leave the call for some reason, please hang up and call back later.  Please do use mute if possible, at times, so that what people are trying to say is not overplayed by typing or eating or television or whatever else as you are multitasking in what you need to do.  Also, please turn off wireless devices as your device provides feedback during the meeting.  You received an audio pin when you signed in.  You  have the telephone number, access code and then there was an audio pin, you will need to have plugged that in to be able to speak on this call.  We have had a few times that people did not realize that they had to do that, and they have been talking and they have not been able to be heard.  So, make sure you did that if you are speaking on the conference call.

O.k., so, I am going to move into Micro-Invasive Glaucoma Surgery or otherwise called MIGS for short. We have three speakers, Dr. Greenwood, Dr. Kliger and Heather Falvey and we will take them in an order.  First, I want to say that this is a multi-contractor policy.  It is originating with multiple contracts, there was a subject matter expert meeting held a few months ago by one of the contractors that served as the basis for the formulation of this policy.  So, now we are opening this up to the open public meeting for the comments from others that may or may not have been part of that meeting. 

So, Dr. Greenwood, are you on and would you like to start?

DR. MICHAEL GREENWOOD:
Thank you, Dr. Moynihan we appreciate the opportunity, Dr. Oakes and everyone else as well to present.  If you are ready, I will get started.

DR. EILEEN MOYNIHAN:
Thank you, and the presentations were sent out, is the presentation being projected?

DR. MICHAEL GREENWOOD:
Yes, we are projecting in the room. Thank you.

Alright. Well, thank you, everybody for your attention again.  My name is Mike Greenwood, I’m a Glaucoma Specialist actually here in Fargo, Vance Thompson Vision. 

We are talking about the IStent inject delivery system and in a moment here, I will pass this around so everybody can see it.  But basically, what it is, it’s a one delivery tool that delivers to separate stamps at two different sites.

They go into the trabecular meshwork and we try and place them at least two clock hours apart, but they’re placed strategically to maximize the outflow.  I believe this is the smallest device that can go inside of a human, meaning that’s approved through the FDA and so it’s a very, very small and very, very delicate kit. The steps that are needed I will go over here shortly, but again, both stents are not placed at the same time, but rather strategically apart. 

Later we’ll go over some of the clinical data. But basically, what it looks like is a small little rivet that gets put inside the eye. It goes through the trabecular meshwork, which is the site of outflow resistance, and that’s why pressure goes up with glaucoma. 
And so, the stents go in, fluid leaves eye  and goes through the goes through the Schlemm’s canal, goes through the collector channels and then gets reabsorbed through the body.

So what you see here is the diagram of the natural outflow of the Schlemm’s canal.  So, again, fluid goes from inside the eye through that trabecular meshwork into the collector channels and then gets reabsorbed. These Collector channels are kind of like superhighways, their small little two lane road, and then you’ve got the interstates. We just don’t have a good way of identifying them yet. But by placing two stents, it gives us greater chance of hitting one of these superhighways which can lower the eye pressure, as effective as we need it to so that these patients can have their glaucoma, not stopped, but progress as slow as possible.

Positioning the stents, again, these are the smallest devices that can go inside a human, that’s very delicate, and so what we have to do, just to get ready, is we have to, for Ophthalmic surgery for those who don’t know, patients are lying flat. We’re looking through a microscope. We use both hands and both feet to do the surgery. So, normally the patient is straight up, but in order to place these stents, we have to use a special, it is called a Gonion prism, but it basically uses physics to allow us to see this angle, or where we need to place the stents. So, we turn the patient’s head 30 degrees away from us.  We tilt our microscope 30 degrees the other direction.

We have to adjust the oculars and then we have to have the patient look to their other ear so we can get a good view, and then we put a contact lens on top of the eye, and then we use our, so our left hand is holding a contact lens, the right hand is holding the stent and then our left foot controls the microscope so we can do fine focus. 

In order to replace these stents you have to have a really good view and so what you’re looking at right now is, what we’re seeing while we’re dong the surgery, the greenish part is the iris or the colored part of the eye, and then there’s a thin brown line that you can see running horizontally.  That  is the target for us, that is the trabecular meshwork, it’s a living breathing tissue, depending on your eye color, depending on your eye anatomy, it’s got different pigmentation in it and what we’ve learned is that the areas of heavy pigmentation, are where these super highways are, where the greatest outflow happens.

So, when we place the stents inside the eye, we try and target the areas of greater pigmentation, it’s kind of hard to see on the screen but on each end of the view here, there’s a little bit more pigmentation.  And so, what we do is, when  we’re placing the stent using the IStent injector, the two stents - as we place the first stent, using the steps that I described. Turning the head, etc.. and then what we have to do is move our hand to a new portion, because you can see we only get a couple, like couple mm which turns into about a clock -  hour and a half on the view there, so you rotate your hand or rotate the patient’s head or rotate the microscope. so that we can get a better view and more heavily area of pigmentation, then we can deploy the second stent. We repeat steps 4-7 so to speak from the precious slide to place the second stent. So hopefully, that makes sense to you guys and feel free to ask questions during or after. Basically, what I’m saying is we place the first stent and we have to re-adjust placing a second.

So, the request that we’re reaching for today with the LCD and the LCA is to cover and pay for all 0376T, which is the code for placement of the second stent.  We think this would be an appropriate approach to compensate based on the work that needed to be done, both, you know with the decision making in the OR work and the aftercare with placement of that second stent, and again, placing two stents is not just simply a double click on the device, but rather repeating some the work that needs to be done.  Here you can see a little bit more of the detain that we’re asking for.

Basically, for the analysis of evidence, removing the language that there there’s no additional payment for multiple devices, so-called dosing, regardless of methods, statistical benefit has not been demonstrated.  The speaker following us, we’ll talk a little bit more to that clinical data, and rather changing it to the IStent to a 2-stent system, there is additional coverage and payment for placement of the second and that again at 0376T.  Again, a little bit more detail here, but recognizing that, moving all 376T from a group II code which is not medically necessary to code, which is medically necessary when the indications of coverage are met. 

I will kind of finish with this next couple of slides here. This is data from our own clinic. Before we had two, stents we just had one, is patients would undergo cataract surgery and we’d follow them out, and this is five-year data.  This is one of the largest and longest follow-ups for a single device, the patient that undergoes cataract surgery, plus placement of one stent, which is what it was indicated at the time.  And you see, these patients did quite well, but that green bar is the number of medications that the patients were on and at the start of the surgery, they were around 1.29 meds. They had the procedure, they had one set in place and that medication dropped.  But as time went by, that number of medications are kind of crept up, and you might think, well, that’s not that big of a deal, to slowly adding on medications, that we would’ve had to stand there.  And again, the clinical data that we’ll show more of later, we’ll kind of demonstrate that putting medication and is not a benign thing that causes a lot of cost to patients, irritation to their eyes and if we can avoid going back on medications, its’ a victory for patients.

This is a patient of mine, to our right- to patients left.  He’s already had cataracts and glaucoma surgery in that left eye, is non-zero medications, and in his other eye you can see he is still on medication. That eye is very red, very irritated and you can definitely tell that there’s a reaction going on because of the medication and so on.

The additional stent requires additional work and time. The data, again, I didn’t show, but someone else will. It shows improved outcomes, keeps patients off medication longer and if there isn’t coverage for that second stent, there’s a really good change that surgeons aren’t going to use this device, because there’s additional costs, and other things that are needed for it, extra work, like I mentioned and they might not have patient’s best interest at hand, they’ll use what’s currently available instead of what might be best for them, if patients may need to go back on medications. 

My final take hope point is just that I’ve got partners in other states, in our own clinic, and they are getting reimbursed for this and they are getting coverage for it, and so, what might be the standard of care across the river with my partner in Minnesota won’t be the standard of care for me, here, and that makes it very hard for us to do what’s best for patients by having that.

Thank you, guys, for your time, and again, happy to entertain any questions.

DR. EILEEN MOYNIHAN:
Dr. Greenwood, this is Eileen Moynihan, I’m sorry, I’m hearing an echo on, right? The IStent injection device would, if it is used for both of those T-Code procedures codes would involve one, correct?

DR. MICHAEL GREENWOOD:
Yes, that is correct. One system contains two stents.

DR. EILEEN MOYNIHAN:
OK, so that these are mostly done in a non-hospital setting, correct?

DR. MICHAEL GREENWOOD:
Yeah, for the most part it’s wherever the surgeon, you know, does the surgery, whether it’s in a hospital setting or ambulatory surgery center.

DR. EILEEN MOYNIHAN:
And pretty much you would expect both stents  to be placed  although they’re quite different location.

DR. MICHAEL GREENWOOD:
Yes, that is correct. Yep.

I can think of a time, just to follow-up  I can’t think of a time where someone would just place one and not place the second.

DR. EILEEN MOYNIHAN:
Unless something unforeseen happened, I’m sure. So the issue where to place the practice expense, it would probably all be with a 1919T and there would be a physician component to the second procedure, correct?

DR. MICHAEL GREENWOOD:
Yes, I believe that’s correct.

DR. EILEEN MOYNIHAN:
O.K., O.K., I’m not sure whether confusion was caused by, maybe FDA labeling of this, or, this is something I will give some thought to.

DR. MICHAEL GREENWOOD:
Thank you, and just to follow up on that question and I think other people might be kind of current FDA labeling is placement at the time of cataract surgery for both stents.

DR. EILEEN MOYNIHAN:
Right, right. I think there is some confusion between practice expense and physician work and I’m just going to try to sort that out later with our group.

DR. MICHAEL GREENWOOD:
Very good.

DR. EILEEN MOYNIHAN:
O.k. does any of our Medical Directors from Noridian have a question?

DR. MICHAEL GREENWOOD:
They said no and thank you.

DR. EILEEN MOYNIHAN: O.k. next I think we have Dr. Craig H. Kliger

Dr. CRAIG KLIGER:
Yes, Thank You, Dr. Moynihan. Thank you all for listening, and we appreciate the opportunity to present, and I have no conflicts to my knowledge and we greatly appreciate the coverage decision that is outlined in the LCD and we think that it is a win for patients.  These are very useful devices, and we, in general , support what’s written.  We have a few issues with some of the working, but I think those things can be ironed out.

So, with regard to IStent and, and/or IStent Inject, there are someone has pointed out that it involved two stents and the indication for the device, there’s again, there’s a footnote that says the device consists of two stents, but we believed that would be clear if it weren’t in a footnote.  It would be in the body of the language and the other gentlemen pointed out, you are trying to put in two stents, that would be the normal situation. 

The other, at some point, however, let’s say you were trying to insert the first stand an it falls into the, into the angle and you can easily retrieve it.  The logical thing would be then to put the second one in because you are in the eye and you might end up with one stent that is working, and we believe that would be a covered episode.  You would probably only bill 0191T because you only actually inserted one of them. But if you were to insert both of them, then you would normally bill the 0191T and the 0376T so we would like some clarification that it, know, your intent is to put both in but there might be a situation where one day for surgical reasons, you can only get 1 and if you get none of them in, that, I guess, I would consider that a non-billable service. But that would, that would be up to coverage decision, if you want to modify the language. 

It was also pointed out that the billing article put 0376T in Group II, and, at a minimum, it would be in, we would want that in Group I, and that makes it a covered benefit. Then we would go on, to ask that, you know, hopefully, there would be some coverage.  The article didn’t indicate that there was the issue of dosing and I think I got clarification from Dr. Moynihan by email that in the case of Istent inject would mean putting in four stents or trying to put in four stents. It would be the device versus the number of stents and that’s where I think there’s some confusion in the way it’s worded, so we can hopefully work with you to tighten that language, but I think the intent would be to be able to bill both codes, because both, both are billable services if two stents are put in with one device.

Turning to the Zen 45 device. This, this gets technical and the more words you put in something that have to be interpreted by a provider or an auditor, the more complex it gets for them to decide whether they’re doing what you’re asking. And, so, yes refractory glaucoma when they did this study had to be defined so an IRB would accept the study. So, they had prior failure of this and that and pressures and but, if you look at the language, you know, greater than four classes of IOP lowering medications or fewer in the case of tolerability or efficacy issues, that basically means you can have anywhere from zero to greater than four medications and still work.

So we wouldn’t want someone to read that casually and say, well, If the patient is a not on four medicines, I can’t do it, even though it doesn’t say that you sort of have this chilling effect where if the doctor is worried that they might not qualify and suddenly I did an audit two years later, might be suspect because the auditor is reading this differently than  you are. Then that provider is, then you know, we would want clarity and we believe also that there’s some issues related to repeat procedures. Again, for them to be done as a standalone, the IStent (unrecognizable)  hydrous and only be done with cataract surgery, so currently that repeat procedure wouldn’t make sense.  But as far as, then those, if someone were to need a repeat procedure, we believe that the surgical decision and so if indeed the doctor felt, that than a repeat of them were appropriate, then that could be available to the patient.  And so, we would want language to make it clear that you’re not referring when you say one, it means one per lifetime, as opposed to one per surgical event, and we would ask if you could tighten that language a little bit, so that it would be clear.  Hopefully, you would agree that it could be repeated, if, indeed, that were the surgical decision. 

As far as the, getting to the simple answer, the FDA, although it had the pivotal trials available when it made its decision, it basically says refractory glaucoma, and it gives some examples, but the reality is that statement, the FDA indication basically says this is a device that is used to treat refractory glaucoma and you can go on to say, unresponsive to maximum tolerated medical therapy and that makes sense to an Ophthalmologist.

We know what this is. We device the essentially, create a hole in the eye that lets fluid out and if you let too much fluid out of the eye in a surgical setting the eye doesn’t respond well.  The eye gets hypogenous and the  retina becomes edematous,  the vision goes down and you don’t want that, and so this is not something just like a trabeculectomy, this is a bit more elegant way of doing a trabeculectomy and that is something that we think we understand. So, we would ask that you potentially rather than list all the pressures, and we just meant to design the study to get an answer. You basically say what the FDA said, refractory glaucoma unresponsive to maximum tolerated medical therapy.  We have no problem with your comment about an Ophthalmologist, who has blood management experience. 

Having said all of this, I will throw this out, because it is what Novitas did, which is one of your other MACs, and if you think about it, the two things you’ve done with this policy are that you have approved the devices for their FDA indications. So, if you really want to get simple, and again, we have support, what nobody thought did. They basically had language that would, they would allow for these devices to be used within their FDA indication.  I believe, that’s similar to what you do with drug therapy, but in general, the simpler you get the language and the more understandable it is to the provider, the better. 

So, this last slide.  We would, you know, I’m sorry. This, we basically, I was saying, we support the Novitas approach and it’s related to the fact that the FDA has gone through a long process to determine that the device is safe and effective, and since it is a device in that, it has to meet the standards of what its attempting to achieve.

So, there will be more of these coming down the pike, and since the FDA is doing its due diligence, it makes it reasonable for, Novitas and potentially, Noridian to accept, essentially accept what has been found, as long as it’s found to be safe and effective, and to achieve a certain amount of pressure lowering, we recognize Psypact  was withdrawn from the market for complications, they may be able to get that reintroduced in some way, we don’t know that yet, but if that was to come back to market we would hope you would provide coverage for that.

So, the simple answer is, as much as I could write it in a few words as possible for you. You intentionally, you would basically intend to cover a single insertion of a device that for its FDA approved cleared use, and I’m not going to read the whole slide, but the key here is that tit is intended to authorize future, FDA approved clear devices, and to exclude any device - if so due to an active recall, which would handle the bypass situation right now.  So, we hope you would consider this, it is similar to what we actually wrote to Novitas as well.  Although, they, this was their decision, our intent writing to. Novitas was to make the language clearer, but this is what we would hope you would consider.  But if you don’t’ want to go this far, the corrections and updates to the other language would be appreciated, and I will stop and have, if anyone has any question let me know.

DR. EILEEN MOYNIHAN
Dr. Kliger, I do know that in our overall, I now know that Novitas has handled this this way and being a member of our original group, but some are very persistent about factual scientific studies and data. So, if you have ongoing studies that are not necessarily the same as the original pivotal study, that would be helpful. 

DR. CRAIG KLIGER
Again, we’re talking to some degree about things that don’t exist yet, but that’s how we can have the studies of those things.  What we’re arguing is that the FDA evaluates the devices and approves them if they are found to be safe and effective.  And so, we believe that in the situation of glaucoma, where the typical goal is to reduce the pressure by a certain amount, the target pressure and to improve the visual loss. So, the fact that those studies had to be presented to the FDA team reasonably adequate. Now, I do understand that there’s both sides to this, and again, this isn’t  an alternative, if you, if you choose to not go that far, because you would prefer to evaluate each one as you, as it comes along, then the alternate, then we would ask is, do you would again clarify the language? So, it’s as simple as possible, but still does what you want it to do.

DR. EILEEN MOYNIHAN
O.K. Does any other Medical Director from Noridian have a question for Dr. Kliger?

DR. CRAIG KLIGER
Dr. Oakes says ‘no’.

DR. EILEEN MOYNIHAN
All right, thanks very much for your time.

DR. CRAIG KLIGER
Thank you very much for yours.

DR. EILEEN MOYNIHAN
The next speaker is Heather Falvey, welcome.

HEATHER FALVEY:
Thank you, Dr. Moynihan and Thank You for the opportunity to speak with you today.  My name is Heather Falvey, I’m a Director of Health Economics and when economists within the Glaukos team, we’d like to talk to you today about IStent technology.
First, we would like to commend Noridian for reviewing our pivotal data, and recognizing its efficacy, and IMP and med reducing efficacy.  I think it is interesting to note the study was conducted in 24 sites within the United States, and the average age of the patients was 70-years old, but I think it reflects well on the Medicare age of the population. So, there’s some relevance of the pivotal data for which the FDA based regulatory decisions on.

What we’d like to talk to you about today further is the two versus one stent data to show the incremental value of that additional stent and why it is  medically necessary, and why it’s important for coverage and payment for that second stent, the 03760T code.
O.k. I think Dr. Greenwood mentioned is the smallest known medical device implanted into the human body. It’s been clinically proven on safety and efficacy.  Istent technology is associated with over 100 peer reviewed publications and the remainder of the data we will show today, reviews the data that can help support the difference between the 1 versus 2 because obviously the bulk of the data wasn’t designed to answer that question, but there’s quite a significant amount of data that we can look to.

I won’t spend too much time here, but if glaucoma is a disease of the optic nerve and intraocular pressure is the only modifiable risk factor, and that is generally the target for primary endpoints for study.  Generally speaking, 18 mm of mercury is the target pressure for many trials and many endpoints and in many ways, if you can achieve lower than 18 mm of mercury, that is a good approach for managing a glaucoma. There are two mechanisms, generally speaking, for glaucoma is either to decrease production of aqueous humor and the other is to facilitate outflow, Istent identity technology associated with the outflow.

Glaucoma is the leading cause of irreversible blindness globally with about 80 million patients experiencing the disease and of that 80 million, 6 million will experience bilateral blindness which is a significant burden.  US figures are approximately 2.5 million and that number is expected to increase over three million next year due to an aging population.

The EMGT is a large landmark study, well know within the glaucoma community and why its important is that this study demonstrated the impact of intraocular pressure on disease progression and showed that for every 1 mm of mercury, it decreased disease progression by 10%. Every 1 mm is important. This picture here, the butterflies, shows what the patient is experiencing as their disease is progressing. The first box could be what the mild patient might be experiencing and as the disease progresses, visual field is decreased over time to a point where a patient with severe disease and the they have almost total blindness or a sort of pinpoints of vision remaining.  So, the goal of therapy is to maintain patient vision as in the first box,  preserve vision as it is an irreversible disease.
There are some treatments available, medication, laser, and more invasive surgeries.  Invasive surgeries are generally reserved for more refractory patients, and we're talking about mild to moderate patient population. Injected indicated a note about the medication.  I'm sure you're all very well versed on noncompliance for pharmacotherapy highly glaucoma. It's not a matter of opening a bottle and a patient taking the pill, there is some requirement of the patient to administer an eyedropper to get the target into their eye. And, as I mentioned, the patient population, approximately 70 years old into their eighth decade, ninth. In some cases, comorbidities start to emerge to make that more challenging, so medication burden is significant to maintain adequate treatment, getting patients off of their medication, as we saw the picture of the red eye.

There's lots of value for medication reduction. MIGS is minimally traumatic, demonstrated to be safe and efficacious and importantly, for the patients, are associated with a rapid recovery.

Arc of flow, Dr. Greenwood touched on collector channels, and what this picture with the graphic on top of demonstrating it with IStent Inject with that second event, a patient is able to achieve increased efficacy with the Arc of Flow, of 5 to 6 clock hours.

That enables some of the outflow to be facilitated out of the eye from the collector channels and let me show you a video here. This is a study done at UCLA in Imaging Study, and in contrast was introduced into the eye prior, and during implementation of IStent and Inject. You can see the increased outflow at the time of implantation, let's see. OK. Now, it's important to note is, on the Collector channel, is a description of some superhighways for more sleepy collector channels by having an arc on 5 to 6 o'clock hour with the second spent. The likelihood of hitting a faster collector channel, it is obviously increased, and that's what this image imaging, allowing us to see more clearly. It's still the same video, OK, getting into the clinical data. There are randomized controlled clinical trial is in progress, and it's planned to go for 60 months, 42-month data has been reported in the published literature. This study compared 1 versus 2 versus 3, IStent in for facilitation of our conversation today, I took up the third IStent data.

We could look at the incremental value of 1 versus 2 versus 3, the data reported in the manuscripts that we will be sharing with you and you've already seen.  OK, this study was a washout studies for patients baseline Intraocular pressure while there are no medications is 25 in both arms to send arm after 37 months, the 1% reduction that 30% followed by 2% reduction with 37% and that translates to a 1.6 mm mercury difference, which is greater than the one that we know is significant for reducing disease progression.

There was some question on the study in the policy regarding statistical significance, and it was not reported in the main manuscript. However, we went back into post hoc statistical analysis, and on the primary secondary endpoint there is the endpoints were found to be statistically significant, and that will be included in our addendum to our comment. Interestingly, the past month, 3 or 4 weeks, two new studies have been published that show the consistency of this result.

This study is conducted as a standalone procedure, meaning not at the time of cataract, point out cataract glaucoma, and this isn't a wait to see the true founding of that cataract. Two studies just published were conducted in cataract population, IStent versus IStent Inject and show similar findings and they are statistically significant between the two cohorts there. So, with I tend to inject 19.1% reduction in a 4% reduction with IStent after 12 months and that translates to a 2.4 mm mercury difference while patient's medication is being reduced by approximately zero-point three medication So, significant IOP reduction while reducing medication burden.

This is the second study that was just published, similar study design, similar results, 12 months comparing IStent versus IStent Inject 29.4.versus 22.8% reduction that translates to 1.8 mm mercury difference and the IStent Inject group has a greater medication free percentage of patients off meds than IStent.

OK, similar to doctor Greenwood’s five-year data, there’s another five-year study of IStent inject. Looking at IOP and medication reduction, the patient starting off at 20, after five years, on their mean reduction, that 2.7, they're achieving goals below 18 while having half a med difference from baseline. glaucoma is a progressive disease, so these results are robust overtime and patients are obtaining IOP goals while receiving fewer meds after five years.

A meta-analysis was conducted by an independent team in Canada, and they compared, so 28 studies met their inclusion criteria. Approximately 1700 eyes were included, and they compared many outcomes, but also included 2 versus 1 IStent and found the difference to be 1.36 mm mercury difference in favor of 2% while reducing medication by zero point two.

This is some of the selected clinical data that we can, we can refer to, to make the case that 2 versus 1 stent is statistically clinically significant and medically important for patients. Physicians at the time of cataract surgery, have one chance to treat the glaucoma. So, it, in our opinion, that treating that patient with the most reduction in medications would be the best interest of the patient. So, we randomized controlled data controlled retrospective comparative studies and data analysis, showing consistent results of 2 stents compared to 1 and the benefit of IStent Inject over the IStent.

I will stop here, and There is any question, please?

DR. EILEEN MOYNIHAN
Are there any questions from the Noridian Medical Directors? I don’t hear anything.

DR. GARY OAKES
So, maybe not you, maybe someone else in the audience, but MRI Safety. Will you get a head MRI? Is this going to suck it out?

HEATHER FALVEY
Dr. Greenwood can I refer to you for that question?

DR. MICHAEL GREENWOOD
Thank you and perfect question.  These are safe, MRI safe. So they are cleared to use and everything with that.

DR. EILEEN MOYNIHAN
Alright, thank you. I have no further questions. I’m sorry, I am still hearing an echo for me. Did someone say something?

DR. GARY OAKES
The last speaker said thank you.

DR. EILEEN MOYNIHAN
O.K., Thank You, everyone who spoke on MIGs, dedicating your time and effort, I appreciate all the additional material.

Alright let me move on to Hypoglossal Nerve Stimulation for the treatment effect of sleep apnea.

We have four speakers for this, that we will take in order of their listing on the agenda: Dr. Kirk Withrow, Dr. Kevin Faber, Dr. Ashish A. Patel and Kathy Sherwood of Global Market Access in that order. You still have a timeframe that doctor folks mentioned and let’s move forward with the presentation after I just say this is a joint multi-contractor policy. The subject matter expert testimony was a few months ago and was held by the Novitas.

So, the first speaker, please begin.

DR. KIRK WITHROW
Yes, this is Kirk Withrow, are you able to hear me?

DR. EILEEN MOYNIHAN
Yes.

DR. KIRK WITHROW
I am Associate Professor at the University of Alabama Birmingham. I've been using this device for some time and just had a few comments regarding some of the wording on draft LCD.  As you see there, participated in discussion with Novitas recently where we had pretty good dialogue regarding these measures. As for there's no disclosure as it relates to this therapy.

So, the, the main thing that I was interested in discussing was some of the language regarding sleep endoscopy training, the there's some, I feel like the way that it's worded leaves some confusion, potentially. Particularly the comment regarding validation of submissions of at least 80% agreement in at least 15 consecutive studies. As you can see on the slide there, I have some potential language change that I think might be more accurate, or rather easier to interpret. In particular, the points in that that I think are significant to consider is that the certification includes training and testing that is done prior to any surgeon becoming an implanting surgeon. So, there is sleep endoscopy training as a part of becoming an implanter, and this is done by the manufacturer.

Additionally, there are the second opinion service that is mentioned in the current wording, is, is something that is done for at least the first five cases and any others going forward, that the implanting surgeon has any concern about, or question about.

On the next slide, the main reason that I feel that that there's some need to change the language, is because, in particular, I think that the 80% wording is problematic if you're looking at the candidacy for the nerve stimulator, where I think there really shouldn't be any disagreement between the surgeon and a representative from the manufacturer. Now, that's not to say there wouldn't be disagreement in the exact grading of the sleep endoscopy, but as it relates to hypoglossal nerve stimulator, I think there really wouldn't be that much disagreement, and I think this is, has been borne out by all of the literature that is out there. Which, kind of skip ahead to my third point, where I think that that that requirement is really not necessary to ensure good patient selection, if you consider the, the high quality data and the significant improvements that are being achieved with this therapy, that would imply that the correct patients are being selected, which would then further imply that the sleeping basket be is being interpreted correctly. And, in the second point there, as I mentioned, I feel like in reading it and, and reading it with other people, there seems to be, you know, several interpretations of exactly what it means. And I think there's, I would have some concerns about how the requirement would be satisfied. And I think if, if the recommended wording is not accepted, the questions that, that I would particularly want to have more clarification on, are listed there, in particular, with the patients. The 15 patients need to be Medicare patients, or can any other patients be used? And do they have to be the submitting provider’s patients, or could they be other patients in which they have looked at sleep endoscopies and then, in particular, who would, who would keep track of this data, and then ensure that it was done? That, to me, seems like it would be kind of a burdensome thing to keep people all in a centralized database other than if you use the physician training program.

And then what if there was a situation where somebody didn't reach the 80% benchmark? Initially, would that be something that could be revisited? Or where would you go from there?

Um, the second point that I thought merited some discussion. If you move to the next slide. Is regarding the shared decision making? Um, the problem that I saw with that is where it said referring physician and that doesn't necessarily, I think a lot of times that means sleep physician. But most of the patients that I see, probably do not come from a sleep physician and, in fact, come in on their own. Or they've been untreated and sitting at home with no therapy. And then they see information about other treatments and then are motivated to see if they can become treated and having failed CPAP and, or oral appliances, in the past. So, I think there just would need to be some clarification as to, what sleep, or what the referring physician means, if that means specific sleep physician. And, also, some of the patients who would have all seen a sleep medicine person may not have seen them for some time.

And then, lastly, on my second point, there, for rationale for change, I think that there should no generally be agreement between sleep medicine and a surgeon, assuming they are different. However, I think, ultimately, the implanting surgeon, you should hopefully be competent to determine, you know, whether the patient has obstructive sleep apnea that meets the FDA criteria for the treatment and the appropriate sleep endoscopy findings, and has failed CPAP therapy. I will be glad to entertain any questions on this or, or anything else, as it relates to this therapy. Thank you.

DR. EILEEN MOYNIHAN
All good points that I'll certainly take into consideration. and when we talk to our overall group, do any of the medical directors from Noridian have any questions? O.K. I know I don’t have further questions. I know that the endoscopy testing was of concern to our group overall. So now, what we do with that, ultimately, I think we'll have to have a discussion among ourselves and review this information that you've sent in. But thank you very much for pointing out your concerns.

DR. KIRK WITHROW
Yes, Thank you.

DR. EILEEN MOYNIHAN
O.K. Moving on to the next speaker.

DR. KEVIN FABER
Yes. Good Afternoon. Are you able to hear me?

DR. EILEEN MOYNIHAN
I can.

DR. KEVIN FABER
Yes. Very Good. Thank you very much, for the time, I think there's a bit of echo, if there's any way to adjust.

DR. GARY OAKES
We’re not hearing that in the room, so I don’t know.

DR. KEVIN FABER
OK, very good, and I will just ignore it in my ear. Very good. Thank you very much for the opportunity to speak Dr. Moynihan the other medical directors. I congratulate Noridian, actually, on the policy they created so far, and a testament to how good it is, is the fact that we're only talking about a few fine points on the wording.

I wanted to echo some of the comments from Dr. Withrow regarding share decision making. You can actually go to the next slide, yeah, thank you.

So, the shared decision making, I also had some concerns about, because the patient may or may not see a sleep physician first, and if they do see a sleep physician that reviews their compliance downloads their intolerability to CPAP, failure of CPAP, that should be pretty well documented in the notes. That is then sent to the ENT, so, then that note from the sleep physician would prove in a sense the intolerability of CPAP, so the wording of making the ENT then also prove that seems redundant and unnecessary.

So, what you see on the bottom there, with the proposed change, I got thinking about this over the weekend, and the fact that, in some regions of the country, they may not be set up the way we are, where sleep medicine sees every patient first, then, refers to ENT, in appropriate cases. So, perhaps, it should be that either the sleep physician or the ENT, the implanting surgeon -  shouldn’t say ENT- the implanting surgeon documents failure of CPAP proves that. So, if either of them proves it in their notes, they seem sufficient in our area, one of our sleep providers is going to document that thoroughly. In other areas of the country, as doctor Withrow alluded to the ENT or other surgeon and might be the one to see them first and could prove it in their documentation. So, I just wanted to call attention to that piece of the LCD. And then, on the next slide, thank you.

It refers to specifically the wording of the type of surgeon. So, it refers to otolaryngologist and appropriate training, et cetera. And in most regions of the country, that's going to be the implanting surgeon is going to be an otolaryngologist, but there are and, maybe, in the future, other areas that may have an oral natural facial surgeon, a neurosurgeon, something like this, that is also equally well trained, equally good at the surgery. But, the policy for that already in the way it's word is specifically says otolaryngology. So, I just wanted to call attention to that, and recommend that there's something more generalized such as is in red, licensed, physician for HNS services.

And those are the only two specific points I wanted to bring up, but I'm happy to answer any questions.

DR. EILEEN MOYNIHAN
This is Dr. Moynihan and do you, in your experience find at the endoscopy training would be something that neurosurgery would be? Um, I don't want to say able to do, but familiar enough? Because this was, was the most challenging piece that people were worried about safety issues about.  So, do, you know, are in fact, neurosurgeons who are doing this? And whether that turning, maybe this is a question to ask manufacturer of the device, more so than what's going on in your system.  But, you know, just understanding that how that whole anatomy is working, do you think that is something that can be easily taught through the endoscopy training.

DR. KEVIN FABER
Yeah, again, I, look on the first slide. I'm a clinical neurologist at Sleep Medicine Specialist so I don’t have direct experience with it, but I know that the training that the company provides would include the endoscopy and it seems to me that the neurosurgeon, although we don't have any in our area doing this, should be able to learn that. It's pretty straightforward. If I've seen the videos, I can tell whether it's anterior poster closure or central closure. So, even a country neurologist like me can see pretty, pretty clearly in most cases
So, I would think that the neurosurgeon would be able to get that training and be not quite comfortable with it.

Same with oral maxillofacial surgery, so, it would seem to me, they would be able to, well, certainly defer to the manufacturer and others on that

DR. EILEEN MOYNIHAN
OK, thank you. And I think one of the other issues we often have, and I'm not going to say it's a matter of how your center is set up, but we do have issues I know oftentimes and say total joint replacement where all the exercise and rehab and medication and whatever that's supposed to be tried before that, never gets communicated to the contractor by the physician who referred the case to orthopedic surgeons, etc.. a and it winds up getting denied. Because the person we're looking at are the system are looking at, is the one who got paid, so the referring physician often doesn't supply the data.

I would suggest that the policy ultimately goes that way, that anybody who is doing that, would clearly get all the supporting data from the referring physician, and have it in their own record, because this doesn't work otherwise, you're already doing that, and that's why it works for you, but that's not been our experience as a contractor.

So, anyway, but I thank you for your comments and if there are no questions from any of the other medical directors, we can move on to the next speaker. Thank you.

DR. ASHISH A PATEL AND DR. ALLEN CHENG
Thanks for giving us the opportunity to present, we will be quite brief and Thank You Dr. Faber for your presentations. What we'll do is just kind of re-iterate really what doctor Favors kind of describe. We are both oral and maxillofacial surgery in Portland, Oregon. And have a pretty busy sleep surgery practice in the last year. We've started placing Inspire devices. We have actually, I think updated seven devices placed on another couple of scheduled and several, waiting pre authorizations are only proposed Change to your policy is exactly what Dr. Faber suggested, which is the inclusion of oral and maxillofacial surgery as implanters.

It seems like a no-brainer and your question now what, we forgot that? We can discuss with the group.

I just wanted to also kind of expand on one of the things that you had asked about Dr. Moynihan about neurosurgeons. Although endoscopy, upper airway endoscopy, is a central component of otolaryngology and to a degree, oral, and maxillofacial surgery as well. It's not as much in neurosurgery, but I think the skill set required is something that a neurosurgeon could very easily obtain. And the reason I say this is because we work with quite a few other, especially where it's not a part of their, especially for example, radiation, oncology, medical oncology. People who take care of patients with head and neck cancer. They routinely have all obtain the skill of doing upper. Now, that's not the same thing, is doing a Dice,  that to say, that these are, these are physicians who've not had any experience doing these types of things during their residency training, they're able to pick up the skill set, because the skill set itself of doing the business, not really that complicated. The hard part about the Dice, really, It's just the appropriate interpretation of the obstruction that Dr. Faber kind of highlighted. And I think that's something that is covered very effectively in the manufacturer's training. So, I would agree with Dr. Faber about being as broad as possible to include all the potential people that might be eventually participating as implanters of the device.

We have no disclosures.

DR. EILEEN MOYNIHAN
You are saying  and the rest of us are trainable?

DR. ASHISH A PATEL AND DR. ALLEN CHENG
Yeah That's what I am saying in terms of endoscopy, that's going to be your concern, yeah.

DR. EILEEN MOYNIHAN
I guess when we talked about this as a group, as we were putting a policy together, that was one of the things that were very concerned. Are people going to do a good job reading this, and  we haven't been making a mistake. So, hopefully, that will not like, Oh, yeah. That's a couple of months out now from, you know, when we started to look at, I'm sure there's more information that community of you feel more comfortable. I just have to get there, too.

And thank you for your comments.

Are there any questions from the other Noridian Medical Directors?

DR. GARY OAKES
Dr. Patel, this is Gary, I’m just curious, are there any residency or fellowship teaching this at this point? And this in fairly new technology.

DR. ASHISH A PATEL AND DR. ALLEN CHENG
There are several fellowships, obviously the most, you know, on the west in our Stanford. And so, I don't know. I thought my colleagues, Stanley Liu was going to be on the call, but I don't know if he is. But he is the fellowship director of the Stanford Sleep Surgery program, and this is a component of their training program both Otolaryngologist Central and Reclamation surgeons to do this. I know there's several, there's, you know, there's several other centers across the country, and that's just the one I'm familiar with, because it's in our region.

DR. GARY OAKES
Thank you.

DR. EILEEN MOYNIHAN
Any other questions? O.k., Thank You, Dr. Patel. I have to move on to Kathy, are you on or there?

DR. ASHISH A PATEL AND DR. ALLEN CHENG
Thank you.

KATHY SHERWOOD
Hi, I'm Kathy Sherwood. Doctor Moynihan we spoke in our discussion. There it is. I'm the Vice President of Global Market Access and Reimbursement for Inspire Medical Systems, and so that is a disclosure. I worked for the company and I on stock.

So, I am very pleased to be here today This is our first open meeting with the max and we've got two more this week as a matter of fact, with the First Coast and Novitas. And basically, we are very pleased, very, very pleased with the outcome and the hard work that all of the MACs have put into development of this important LCD. And we are particularly noteworthy the amount of evidence-based medicine that it's very clear. And, you know, maybe, for the first time in my career, I have no- input on the patient coverage Criteria to Perfect. So, thank you for that. It mirrors the FDA indications and the public published evidence. So, we just have two small points. And they've both been brought up already as industry, one about the implanting Physician and I'll go over our training program in my next slide, a little bit.So, maybe that can help show what actually goes into getting certified to do this implant. And then the second with the Dice training, we actually really liked the idea.

DR. GARY OAKES
This is Dr. Oakes, if you're not speaking and you're on the phone, if you could, please mute your phone.

KATHY SHERWOOD
Thank you

Yes. So, the Dice, I'll give some commentary on that we actually commend the inclusion of these enhanced dice criteria. We actually commend the inclusion of these enhanced dice criteria. We have a suggestion for, perhaps, an alternative way of performing that, so that we can still meet our FDA requirements for our manufacturing practice compliance so that we're, we're actually tracking all of the physicians and all of their day reviews. So, here's a quick overview of the training program that we have, and it looks like the font is pretty small, but hopefully, you can read this. The bottom line is, we are a single technology company. We cannot afford to have physicians doing this implant where we're going to get that outcome. It would be, it would be a disaster for the therapy. It would be a disaster for the patients, and we would probably be out of business. So, we take training and certification very, very seriously and we actually will not ship product to any account where the physician who's doing the implant does not have a formal certification and the certification takes many months to achieve. So, there is a beginning prior to them ever doing even cadaver training. There is an introductory session. There's a whole series of implant videos that the physician has to go through with our Training Director, and then there's an entire module on Dice training and we're going to get into that in just a moment. Once they've completed all of those modules, and again, these are typically live courses that the physicians take with our training group. We travel around the country. Then they go to cadaver training. And then, the first implants are actually attended by an industry trainer as well, and this can be as many as 5 to 10. So again, we've got people all around the country that go into those centers and help kind of guide the surgeon with the placement of the nerve cast, the respiratory sensor, and any in addition with making sure that those days before the implant are reviewed properly.

So, we actually collect those certifications. We track all of this and it goes into our quality system. So it's tracked and our quality database and when the FDA comes in for their annual reviews this is actually something waiver procedures that says We will do it and therefore the FDA validates that in fact, we did, um, so let's get on to our recommendation about the implant or we agree most of the time this is going to be an ENT that does this procedure or a dual boarded sleep ENT.

But in some geographies, particularly as you get into communities that are maybe further from the large cities. In some cases, there really isn't a head and neck surgeon available, but there's a great maxillofacial surgeon or there are neurosurgeons who are doing the vagus nerve stimulator which is just the next cranial nerve over. So these people are obviously very qualified to do this procedure So we actually kind of liked the language, that Palmetto put into their draft LCD, which published two weeks ago, basically, saying that a license qualified physician who has been trained and acquired the expertise within the framework of residency or fellowship program, et cetera, et cetera. Basically, be allowed to do this leaning on the fact that every one of these surgeons are going to have to go through that, that rigorous manufacturers training program. So that's point number one.

Point number two with the Dice. Again, this Dice, training is really important, and I think Dr. Withrow, which really made a great point of describing there's a difference between interpreting whether or not there's complete concentric collapse or actually having total alignment on every small perspective on that day, and we agree that the language might lead people to be a little bit confused.  So we're basically suggesting that, well, maybe I'll, I'll, I'll finish with the training here.

So, physicians are trained, and there are multiple components of that training for Dice.

So, it's a combination of actively collecting best practice techniques, and having a panel of recognize physician experts. I believe doctor Withrow himself is one of those and we need not only do the training certification. We also offer a second review service, because sometimes it is a little bit tough to tell is there concentric collapse or not and if there is, moving the tongue out of the way, is not going to open up the airway. So even our experienced physicians will sometimes send their ... For review. I think Dr. Mitchell said he just did that a couple of weeks ago and he's done many, many implants, OK, so the recommendation for the dice policy language, we had an idea that might make this meet both the max desire to enhance the training to have a specified number of 15 to allow us to do 10 of those 15 through a video clip which is in that dice training module, prior to ever going to a cadaver training. So essentially, we would have 10 prerecord a Dice, where our group of expert reviewers actually agree themselves that, in fact, there is or is not complete concentric collapse and whether or not this patient has a good candidate for ... stimulation, and that would, that first 10 would be instituted in the form of an actual test, which goes into the training record, which is, again, put in our quality system. After those that passed, if the position the potential implanted passes, then we go on to receiving five Dice that they themselves have done, or, again, I think it is a good question. Does it have to be a Dice that the implant or good, does it have to be a Medicare patient? I think all of those are pretty good questions to answer, but this is maybe one solution to still meet the idea of 15, but not have the burden for us, the manufacturer, to actually track 15, Dice video clips, and keep them in our quality system for the next 20 years. That may be a little bit Cumbersome,

OK, so, that's it, thank you, Are there any questions

DR. EILEEN MOYNIHAN
I don't have any on, do any of that, whether medical directors, questions?

KATHY SHERWOOD
No, OK, well, thank you again, we’re really, really pleased with this LCD. 

Great.

DR. EILEEN MOYNIHAN
Thank you everyone for your time and effort, and we appreciate all the comments, and we'll certainly take them into consideration.

I don't know if  there are any other comments that you think about the word feature, we get them in writing, as well.

Anything else, Gary?

Just looking around the room.

Anyone else have any comments?

DR. GARY OAKES
Let’s see, shaking of no head. So, at your leisure, Madam Chairman, we can conclude this meeting. OK, then. Thanks again, everyone

CHRISTINE BURNSIDE
I can make a note that this, Christine, for those of you, if we can disperse rather efficiently and they will be coming in to set up for a meeting bright and early tomorrow morning in this room.
But appreciate that. Thank you

DR. GARY OAKES
Well, it's time to go home or to the hotel. anywhere but outside, because it's still pouring rain, and there's a bigger for sale coming shortly, you might want to get to your car before that happens.