Multiple Local Coverage Determinations (LCDs) Open Public Meeting - July 13, 2023 - JF Part B

Kari Dupreez:
Good afternoon. Welcome to the Open Public Meeting for four (4) proposed LCDs, Amniotic and Placental Derived Product Injections and/or Applications of Musculoskeletal Indications, Non-Wound DL39116 for JE, and DL39118 for JF.

Respiratory Care DL34149 for JE and DL37293 for JF.

Transurethral Water Jet Ablation of the Prostate DL38705 for JE and DL38707 for JF.

Micro-Invasive Glaucoma Surgery, or MIGS, DL38299 for JE and DL38301 for JF.

Before we begin the meeting, I would like to make the following announcements: This meeting will be recorded. The recording and written transcript will be posted on our website following today's meeting.

All lines are currently being muted and will remain muted throughout the meeting.

Only those who registered to present will be allowed to comment on the proposed LCD's today.

For the presenters, you are being allotted 10 minutes to make your comments.

Your line will be opened when it is your turn to speak.

Make sure you are not on mute within your system, or we will not be able to hear your comments.

You should be prepared to begin your presentation immediately when called upon and will hear the moderators voice when one-minute remains.

By signing in today, you are giving consent to the use of your recorded voice and your comments.

Please be mindful of sharing any personal health information during your presentation.

In addition to comments that are made today, all comments should also be submitted in writing.

All written comments received will be recorded in the response to comments articles.

I will now turn the meeting over to Dr. Janet Lawrence. Dr. Lawrence, you may begin.

Dr. Janet Lawrence:
Good afternoon, everyone, and my time will be very brief. I am just speaking to Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Wound. You see or have the JE and the JF draft numbers.

I do not have any registered speakers, so I will simply, at this time, invite anyone who has comments to follow the instructions given by Kari for written comments. The comment period is open, and we would be happy to accept those as instructed.

Thanks, everyone.

That is all for me.

Dr. Larry Clark:
Kari am I ready to go?

Kari Dupreez:
Yes, you are up, and ready Dr. Clark, you can go ahead.

Dr. Larry Clark:
I just don't want Dr. Lawrence to feel badly in that I have two policies, and nobody showed up.

But, but actually, the truth is this is a little bit of, uh, we could call it the triumph of the 21st Century Cures or transparency of the 21st Century Cures.

What we're doing today is introducing those of you that were kind enough to come, to something that I think you're going to be seeing a little more of in the future, and that will be multi-policy meetings.

The two policies that I'm going to be presenting, and you can see the Respiratory Care and the DL, the draft 34149 and DL37293, which will change to the designation L on their future effectuation. These are future effective policies.

Um, what we are doing here is essentially revising a policy that was a little bit different in both jurisdictions.

There have been, by our intent, no changes in the extent of coverage.

What we felt was that in terms of the community of practitioners using these services, primarily respiratory therapy services, and the different aspects of pulmonary function testing, spirometry, lung volume, compliance, diffusion capacity, et cetera, that rather than having them separate with a confusing overlap of codes, we would integrate this into one policy and have consistent policies as CMS expects across our jurisdictions.

In the past, we would not have brought this to your attention, the Cures mandates that when you are making relatively significant changes, we present it to you in an open forum, draw it to your attention.

You will have the same comment period as the other newer policies that you are hearing today, and our intent is not to change coverage on anything.

We do not, we did not expect a significant turnout of speakers but if you find that, we missed a code or something in the synergizing of these two policies into one, please let us know and I appreciate your attention here.

And the second policy, Kari, if you would for me, please, is an evolving collaborative policy, again, something a little bit different.

Noridian is exercising its or demonstrating its responsibility as one of the collaborating MACs that we're going to, uh, open this policy to your comment in our jurisdictions in JE DL38705, in JF DL38707.

This is a collaborative response to appropriate and thoughtful comments.

Revising and expanding this policy for coverage of the continuance of the water trials showed that this technology was favorably safe in a group of patients, even exceeding 80 years of age.

Something that wasn't clear until the trial was extended, and patient safely derive a clear benefit from this technology, with no added risk, over existing technologies, and, in fact, even a more favorable profile in some. Also, the continuance of the trial demonstrated that larger glands, such as 150 grams, were favorably handled without adverse complication, even in the senior population, and so the contractors participating in this collaborative process are all expanding, this was favorably looked upon by the AUA, in other neurologic organizations. We did not anticipate any controversy.

I think everybody was happy with the direction of this decision, but, again, the requirements of transparency and present presentation in a public facing manner are being fulfilled today for this contractor, and, again, we welcome any comments, although we, we do not think there will be many, if any, at all, because I think we've received significant favorable commentary from everybody involved. And, with that, I'm going to wrap it up and turn it back to Kari for Dr. Moynihan's introduction. Thank you.

Dr. Eileen Moynihan:
Kari, I can just start speaking.

Hi, I'm Eileen Moynihan, thank you all for joining today.

I think that I have the most comments for this meeting and I'm chairing this section on Micro-Invasive Glaucoma Surgery.

You have the draft numbers before you for JE and JF, but I'll repeat them for any of you cannot see this slide. It's DL38299, for JE, and DL38301 for JF.

The reason that we have this before you today is because the original MIGS policy was needing some updates based on new technology and techniques.

We have seven speakers, I believe, today, each having 10 minutes, so I am going to ask the first speaker to begin.

Thank you.

Dr. Craig Kliger:
Thank you, Dr. Moynihan, unless I need to wait for someone else.

My name is Craig Kliger, I'm with the California Academy of Eye Physicians and Surgeons. I had a slide deck.

Thank you.

I do want to say that my comments are mostly introductory, and I will be leaving the science and study comments for people that follow. Next slide.

I don't have conflicts except my employment. Next slide.

I do want to make a generalized comment, because I, as an executive for a state society, field a lot of comments from people.

There is a feeling out there that there is some level of, of impetus for this related to problems billing certain ones of these.

However, we as a society, strongly support the idea that these things, every service provided to a Medicare beneficiary must be medically necessary and we welcome the LCD as an opportunity to talk about these things.

We do believe, however, that, hopefully when you've heard all the comments that will follow, that you will find that, that essentially all the procedures that are being classified as experimental will hopefully be viewed as medically necessary, in at least some circumstances, but probably generally. Next slide, please.

I just, you know, there's a terminology, some people use lumpers versus splitters.

I just wanted to sort of reframe the discussion as the kind of surgery your experiencing.

I'm not gonna talk about all of these and you can see that the ones that are yellow are the ones that are listed in the LCD and the others are, I take it back, the Xen and the ones on the left are in the LCD, but they're not being classified as experimental.

The, you know basically, for Goniotomy and Trabecular, if you're doing a Trabecular meshwork bypass surgery, and that includes AbInterno trabeculostomy and all these terms, that sound different but, they're actually, essentially, the same in a lot of ways. And the question of, you know, for example, Goniotomy, all of these are ways to do Goniotomy, they are just different techniques. And, the question becomes, if you do a Goniotomy in a different way with a different tool, do you get a different result?

And, that's hard to prove, a lot of times, a lot of some of these procedures because they involve instruments that are made by industry had the advantage of, they tend to have an incentive to do studies on them, whereas you can do a Goniotomy with a bent needle, if you so desire, if that's your technique, and that can legitimately produce a good result and the same outcome, which is, again, bypassing the trabecular meshwork, and essentially creating access to Schlemm Canal, and, and possibly the, you know, the collector channels and things like that indirectly.

So, you can't always expect that there's going to be a study of every single technique.

We really are just looking at the key thing with goniotomy or all these procedures do, they lower eye interocular pressure, which is the, essentially, the gold standard of how glaucoma is treated. That is even medications. That is the gold standard.

Do we get an effect on interocular pressure and hopefully the, the, whichever technique a surgeon might choose, this is a surgical decision, they would then, you know, be able to reduce the medication burden, which would then reduce the cost to the patient, which is ideally, what comes out of these processes. Again, I don't wanna go through this entire list, but they're all, they all sort of share that common denominator.

Next slide, please.

Ah, sorry, have to move around the little thing.

I'm going to raise an issue that is more related to billing.

But I do think it's very important, conceptually, if you use the technique that's been used to, to restrict some of the services, essentially, all the services in this new LCD actually make them experimental or non-medically necessary, because that is the case, the service becomes non- covered under Medicare.

Therefore, it can still be performed and billed for with a beneficiary notice of non-coverage.

The surgeon must have, of course, legitimate evidence that they believe the surgery works in their hands and, you know, studies that they believe would support that.

But the point is that they can then because you don't have control over it anymore, they bill with an AG, GA modifier excuse me and an ABN, and then the patient pays the full, agreed upon rate. Next slide please.

This was an issue that Dr. Oakes, who I don't believe is on the call, but I worked with him on a concern that before we had the new codes, the combined cataract and MIGS codes that I listed, we could bill 0191T and 0376T.

At the time, 0376T was a code that only that was labeled, not medically necessary, and so, next slide please.

You know, there were more than just this one example, but this was an example of a claim that, you know, we, we, we're aware of and I'm guessing the allowed on 0191T is an approximation, I couldn't remember but it's close to that. You would bill the first one, it would be paid under the Medicare rate and then if you billed the second one and the patient agrees, you can have, whatever you want, $1800 would be paid because the system will tell the patient that you were told, this wasn't necessarily covered by Medicare and you're responsible for it. And we're const, you know that that raises a concern of what I like to call a Wild West Scenario.

I mean, again, we will trust that surgeons will do something they think is medically necessary, but again, there will be a difference between what Noridian thinks or nationally as this is a national MIGS national LCD, or at least a collaborative LCD, you know, that they will, you know, Noridian may think differently than the MAC or practicing surgeon, and the surgeon has studies that they think are adequate then they, you know, there, there may be a difference of opinion, but the patient may be may suffer somewhat, if this is, if this isn't deemed medically experimental. Next slide, please.

Lastly, I would like to just comment briefly on the language issue that Dr. Moynihan, thank you very much, I'm going to praise you for this when the, when we discussed the prior MIGS um, situation, it's a LCD prior MIGS LCD.

We were, we discussed, and you agreed to simplify the language so, that it only basically said maximally tolerated Medicare medical therapy, the part greater than 20 greater than four classes of IOP, lowering medications, or fewer in the case of tolerability basically means you can have zero.

And it's it was those were those were the criteria for the study they did to approve the device, but that's not real-world practice.

We're talking about refractory glaucoma. People know what refractory glaucoma is if they practice ophthalmology and that's reasonably well accepted.

So, we would request that because of Dr. Moynihan's understanding and consideration that you would consider removing at least in the Noridian version which keeping the language that's in the current LCD about this that doesn't create what I call a chilling effect. People think, oh, my gosh, if I don't have the person on four medications, you know that that's the kind of machinations they're gonna go through if they read that.

So, we really think they know what Refractory Glaucoma is, maximum tolerated medication therapy that's well understood and we would appreciate you returning to that, if you, if you would.

And that is my last slide, except for the if you do have questions, I'm happy to answer them and I apparently didn't use the 10 minutes.

Therefore, who's next?

Dr. Eileen Moynihan:
Thank you very much.

Doctor Kliger, thank you very much for your time and effort.

I think that we're just going to move on to the next speaker, but I've certainly noted everything you've said and as you have pointed out, this is a multi-jurisdictional effort so, sometimes I win, and sometimes I don't. But that's all I'm going to say right now we'll see how it turns out, but thanks for the comments and make sure we have everything written if there are additional ones.

Next speaker is Dr. Turalba

Dr. Angela Turalba:
Yes.

Yes, thank you. I also have slides prepared if those could be pulled up. Thank you.

Good afternoon, everybody. I'm Angela Turalba. I'm a practicing glaucoma specialist and Associate Chair of Visual Services at Atrius Health.

I want to thank Dr. Moynihan and organizers for the opportunity to present on this impactful proposal to limit coverage for some of our surgical treatment options for glaucoma.

I'm here on behalf of American Glaucoma Society, the American Academy of Ophthalmology and American Society of Cataract and Refractive Surgery as we make a case that this determination would impair our ability to care for patients with glaucoma. A chronic progressive, vision threatening family of diseases. Next slide, please.

I have no conflicts to disclose. Next slide, please.

So, glaucoma patients require continual often escalating therapy from diagnosis to the end of their lives. This can occur over decades and eye drops are often used as first line therapy, but many patients have difficulty using them. And using multiple drops markedly decreases adherence.

So, for each patient, a target pressure below which progression of vision loss is not expected, defines the goal of their care.

Refractory glaucoma refers to intraocular pressure or IOP, remaining above target despite the use of multiple medications or fewer medications when tolerability or effectiveness limit the use of certain drugs.

Note that this definition does not include an arbitrary eye pressure cutoff as patients progress at varying pressures.

For patients who are progressing, or likely to progress at their current eye pressure, a carefully tailored surgical treatment approach is often the next step in saving your vision.

Next slide, please.

I know that previous, the previous speaker had already gone over some definitions, but a brief review of the surgical approaches being discussed might help frame the discussion. Goniotomy refers to the incision, excision or cleavage of the trabecular meshwork, which, overlies Schlemm's canal, the eyes natural outflow pathway.

Techniques in this class include what we've previously called AbInterno trabeculectomy, AbInterno trabeculotomy, using gonioscopy assisted transluminal trabeculectomy or other devices and other techniques included those listed here.

Canaloplasty refers to direct relation of Schlemm's canal by cannulation or injection of a Viscoelastic agent in a technique known as AbInterno canaloplasty. The listed devices are among those used in this way.

It feels appropriate at this moment to note coverage of trabecular bypass stents which also addressed this anatomical point of outflow resistance in the drainage angle.

Given mention of cyclophotocoagulation or application of laser energy to the ciliary body, in the language as a draft determination, as well as the CPT code for eridoplasty or application of energy to the peripheral Iris, those definitions also feel relevant.

Next slide, please.

Since the 1960's and 70's, Goniotomy has been a mainstay in the management of glaucoma in young people in whom eye, high eye pressure, often results from outflow resistance at the angle.

The goniotomy is also a necessary treatment for adults with glaucoma. Subconjunctival blood forming and external filtering surgeries, such as Trabeculectomy, Tube Shunt implantation, Xen Gel sent insertion are effective for dramatic IOP lowering but come with attendant morbidity and long-term risk of infection and other complications.

Patients with glaucoma refractory to medical management who may require only modest IOP reduction need safer options.

Among which angle surgery's like Goniotomy and Canaloplasty have become standard of care.

Moreover, many patients are poor candidates for filtering surgery and for the Trabecular bypass stents currently covered.

Surgically, Goniotomy does not require dissection of punch in Tyba, which may be damaged or scarred from chronic topical medications, systemic disease, or prior surgery.

Lastly, angle surgeries often performed at the time of cataract removal, which on its own cataract surgery provides inadequate IOP reduction in the majority of glaucoma patients may even cause transient eye pressure spikes and may also lower the success rate of simultaneously performed external filtering surgery.

Next slide, please.

I'm highlighting here high-quality evidence underpinning they use the Goniotomy in adults as standard of care. A prospective randomized clinical trial comparing cataract removal by phaco/emulsification, plus Goniotomy to phaco/trabecular bypass stenting was published in August 2020.

More phaco/goniotomy eyes than phaco/stent eyes met the clinically significant primary outcome of greater than 20% IOP reduction or reduction of medication burden by greater than or equal to one drug at 12 months. This result was statistically significant.

Next slide, please.

You can see that this trend held at all post-operative time points demonstrating that Goniotomy combined with cataract surgery, is at least as effective as trabecular bypass stenting.

Next slide, please.

The literature supporting Goniotomy in adults with glaucoma stretches back to the early 1990's, and we briefly present results from a review and meta-analysis of outcomes of Goniotomy or AbInterno Trabeculectomy published between 2008 and 14.

From this first forest plot, you can appreciate that the weighted mean difference of the reduction in eye pressure between baseline and final measurements was significant for both standalone and combined cases.

Next slide, please.

The same meta-analysis also supports the fact that Goniotomy reduces medication burden in adult patients with glaucoma.

Next slide, please.

Canaloplasty has also been extensively studied in adults, and here we briefly touch on 12-month results of a study of AbInterno canaloplasty or ABiC and combined phaco/ABiC.

Here, blue bars represent pre-operative eye pressure and orange bars, eye pressure at 12 months after surgery.

The asterisks indicate that this change was statistically significant for all eyes, both those undergoing standalone ABiC and those undergoing combined surgery.

Next slide please.

Lastly, Cyclophotocoagulation or application of laser energy to the ciliary body to reduce aqueous production and IOP is a necessary tool in our armamentarium to treat glaucoma.

We were somewhat puzzled by its inclusion in the draft LCD, because this approach has been saving vision since the 1930's and its efficacy and applicability only improved with the introduction of endoscopic cyclophotocoagulation and micro pulse delivery. While it is used judiciously, typically as a treatment of last resort for patients who are poor candidates for incisional surgery or have limited visual potential, it is an effective and important piece of our standard of care for glaucoma.

Next and last slide, please.

In summary, patients with glaucoma, which disproportionately affects Black and Hispanic persons, need access to a range of surgical procedures reflecting individual anatomical and disease features.

For many patients when medical treatment is inadequate, their glaucoma condition may not be severe enough to merit higher risk filtering procedures.

For these patients, minimally Invasive Glaucoma surgery, like the angle-based procedures discussed today, preserve quality of life, and may reduce total costs to the health care system.

We urge you to ensure that Medicare beneficiaries with glaucoma continue to have meaningful access to these transformative procedures by providing coverage for minimally invasive glaucoma surgeries, including goniotomy, canaloplasty and cyclophotocoagulation.

Thank you very much for your time and attention.

Dr. Eileen Moynihan:
Thank you, Dr. Turalba, and I appreciate the time that you've spent putting this together, as I'm sure our attendees do, as well.

Any further written comments that you may have, be sure to send them, and, again, I appreciate your time.

Dr. Nakatsuka.

Dr. Austin Nakatsuka:
Yes, hello, can hear me? Yes, you can hear me, OK?

OK, I apologize. This will be fairly shortened, because I'm in the middle of the clinic, but I also don't have a whole lot more to add to what my colleague previously stated.

So, I'm also speaking on behalf of the proposed LCD that discusses Minimally Invasive Glaucoma Surgery, specifically, canaloplasty and cytophotocoagulation, which I do not happen to mention in this particular slide set, but I do feel is just as important, if not more important, in terms of coverage and trabeculotomy and goniotomy.

Next slide, please.

One more click.

So, I'm the Assistant Professor in the glaucoma division at the Moran Eye Center, which is located in Salt Lake City, Utah. We are ranked as a top 10 eye institute in the country by the US News & World Report, are over 40 ophthalmologists offering full range of care and procedures.

We currently have in our division eight providers, including Dr. Iqbal Ahmed, who is very well known in the glaucoma community, and he has actually been considered by some to be number one ophthalmologist in the world, which can mean many different things, but that was listed to me.

[unable to hear] is a very well-respected colleague. He actually happens to be here today, and he is actually one of the, he is credited with coining the term MIGS or Minimally Invasive Glaucoma Surgeries and also supports most of the statements here.

We are the largest Eye Center in the Mountain West and we cover a large catchment area, which includes the listed states even though we are predominantly, we are located in Utah we have patients, patients every single day that come from the surrounding states, We also have a very prominent Global Outreach Division that is funded through fund raising efforts and we serve the nearby Navajo Nation, which I also take part in and do both cataracts and glaucoma surgeries, and over 25 other countries abroad as well, and they do trips at least monthly to those locations. We have had a fair number, we have a large number of glaucoma patients, and we offer glaucoma care coverage on all Medicare plans.

Next slide.

OK, so I'm sorry, I did not include a disclosure slide. I do have one disclosure, I have spoken for a company, New World Medical, which does create, which does have a device that does, is one of many that does canaloplasty.

However, I mention, I am familiar with using and use utilize at least three different four different devices and if you want to add a needle technique as well, five different ways to do canaloplasty and goniotomy.

Just very briefly, just repeat what my colleagues spoke about, Minimally Invasive Glaucoma Surgeries in terms of the paradigm of glaucoma treatment, traditionally it was drops, laser, and then larger filtration surgeries, the insurgents of Minimally Invasive Glaucoma Surgeries offered us an amazing option to control glaucoma earlier and at perhaps more mild stages before they get to more severe stages, with much less risk involved, as we know, drops can cause a significant side effects both systemically and topically as well. We have poor compliance related to that as well. Lasers also have some side effects, as well, I find them to be not quite as effective as well as MIGS procedures and explicit filtration surgery.

Dr. Eileen Moynihan:
Doctor,

Dr. Austin Nakatsuka:
Yes,

Dr. Eileen Moynihan:
Could I ask, is there any, I'm assuming that noise, is background noise, where you are.

Dr. Austin Nakatsuka:
Oh, should I move?

Dr. Eileen Moynihan:
I'm just, I'm just saying, there's a lot of competition for hearing you.

Dr. Austin Nakatsuka:
OK, give me just a second, let me just move here, exit door here.

Is that better?

Dr. Eileen Moynihan:
Definitely.

Dr. Austin Nakatsuka:
OK, I'm currently at work right now, and they're very busy.

Sorry about that. So, OK, filtration surgeries. We know that these can be very difficult to handle.

Can we next slide, please.

Yeah, so, you know, we've already gone into depth about this there is actually a fair amount of data out there that is not currently being considered. In terms of trabeculotomy/goniotomy data, including data that, yes, is built upon, what is considered to be a slightly different disease process congenital glaucoma since the 1950's, but we have personally found, and we have data to show, as you can see, that this, these procedures also work effectively in primary open angle glaucoma in adults, and a particular population that is known amongst glaucoma specialist that this these procedures work, especially well with steroid response glaucoma, which often occurs in much younger patients. We have a uveitis department here that specializes in ocular inflammation, and I share many patients with these providers who have secondary glaucoma related to the steroids that they need to be on to control their inflammation, and these particular, these particular interventions are extremely good for controlling steroid response glaucoma, which we feel, and there's some data to show that most of the pathology occurs at the trabecular meshwork, therefore, creating an automy, or even a canaloplasty, does a whole lot of good, just from experience.

I have numerous patients who are on full medical treatment, including oral, carbonic, and hydrous inhibitors with pressures that are extremely high and dangerous and we do one procedure, and all of a sudden, they are off drops with pressures down below even down below 10.

The canaloplasty, trabeculotomy, AbInterno procedure is also an accepted practice in the organizations that my previous colleague had mentioned.

So, this currently is part of my glaucoma treatment paradigm in terms of treating mild, moderate, or sometimes even severe glaucoma, and I've mentioned here eye tracking OMNI, but I also use streamline and Kahook dual blade and I have also used a needle as well.

Next slide.

So, we kind of stated some of these, but why is it necessary? Next slide.

So, these are just some pictures to represent, some of the complications that can occur with larger filtration surgeries, such as we see here up in the upper left-hand corner issues with the tubes that we put in people's eyes. I, myself, have experienced a number of exposures that I have had to repair, and including some that have led to devastating infection inside the eye, pictures on the right indicate a trebulectomy, a blood related trebulectomy surgery, which can cause issues such as the top one is infected, in the bottom one, is a large blood that can sometimes cause significant pain, or irritation and the picture in the middles depicts a very large defect in the iris that is actually surgically created, sometimes for these types of procedures and can cause some debilitating dystopias, or issues with glare.

And then we talk about the glaucoma stents, so these are pictures of that I experienced myself, so the left one is actually a Zen stent, gel stent that has migrated into the anterior chamber and had to be removed to do that myself. The one on the right is a hydrous that is obviously sticking out and not in the position that it needs to be.

Just yesterday I was hoping to show a video of this, but just yesterday I placed and Istent and during the irrigation aspiration phase or when I was removing the jelly from the ISO after the state had been well placed, one of the stents came loose and was flying about in the eye and for a while we had difficulty finding it because it is a tiny small little stent, but we cannot leave it in the eye and finally, we were able to find it and remove it, and that can happen for any of these stents, I've had a number of stents that I've had to remove or adjust, because they were causing some rubbing on the Iris or some other problems in their case their reports and studies showing some infection risks related to the stents.

Next slide.

So, the Canaloplasty procedure, basically is to dilate not just the Schlemms Canal, but also downstream channels, which are not accessible really with the bypass stents, like the Hydrus or the Istent, and there's data that show that that can further, um, increase pressure, even beyond sometimes what the stents can provide.

Next slide.

I'm not gonna go over this literature anymore and belabor that point, but just to show that these are some of the same studies, but that, there are, there is data that may not have been taken into account.

Next slide.

So, my final recommendation is that providers in Utah and throughout Noridian's other regions have continued coverage of proven standard care treatments we used preserve our patients' vision, which includes the MIGS procedures, but that also includes canaloplasty and trabeculotomy procedures such as OMNI, Itract or Dual Blade or any of the other devices that are used utilized to do these procedures, and that would help, at least here, for us, us to serve our large catchment area of the Mountain West, including those underserved populations.

Just as a really quick aside, I have many patients that come from 4 or 5 or even more hours away, Montana, Wyoming, Idaho, and for a number of them, these particular procedures are much more are much safer because one we're not leaving a stent in the eye that we have to worry about and two I can't do certain procedures like a trabeculectomy in order because I just can't do the post-op care safely with these patients because they just can't stay in town that long, so these types of procedures are particularly useful for those types of patients in that population, which I have many of.

Thank you for your time.

Dr. Eileen Moynihan:
Thank you very much, and thank you for your presentation, especially since you're in the middle of work hours, we appreciate it.

Um, I'm gonna move on to Dr. Matthew Trayner.

Doctor Trayner, are you ready?

Dr. Matthew Trayner:
Yes, I'm ready.

Can you go to the next slide, please?

I'm also discussing this Minimally Invasive Glaucoma Surgery LCD, I'm an Ophthalmologist and Glaucoma specialist located in Eastern Idaho, next slide please.

Our practice, we provide subspecialty care for Eastern Idaho and surrounding states, we have seven doctors, multiple clinics, we provide a full suite of vision care services, including MIGS and other glaucoma procedures and other eye surgeries, caring for a patient population with many, many Medicare age beneficiaries, and this would impact them dramatically. Next slide please.

So, MIGS procedures how are they used by surgeons?

So, in years past, we had a much more limited armamentarium of procedures whereby we could treat patients with glaucoma. Thankfully, in the past 10 plus years, there has been an increase in the number of options available. Not all patients have the same needs, and not all patients respond the same way, and so having a variety of options is, has been a great blessing and being able to treat patients with varying needs. MIGS can benefit patients in all stages of glaucoma, but it's most commonly utilized in patients with mild to moderate glaucoma, and it also has a great benefit of hopefully avoiding, postponing more invasive surgical procedures such as trabeculectomy or tube shunts. Next slide please.

So, MIGS procedures as the aqueous outflow of the eye decreases, then the intraocular pressure may increase, resulting in an increased risk of glaucomatous damage.

MIGS procedures target the area of the outflow, the trabecular meshwork, and then Schlemm's canal trying to improve the flow into Schlemm's canal, which can then help reduce glaucomatous damaged by lowering the intraocular pressure.

As has been discussed, there's a variety of different ways, different approaches to MIGS, including trabecular bypass with stent placement, excision of tissue, or enhancing aqueous outflow through Schlemm's Canal as listed here. Next slide please.

So, I'm gonna address specifically canaloplasty via the internal approach, which is a variety of different companies, the OMNI surgical system, the ABiC or AbInterno Canaloplasty and there are others as well. These target the drain of the eye or the Schlemm's canal through the trabecular meshwork, and as you can see here in this, in this diagram, we can see the area of drainage from inside of the eye and this is the area targeted by MIGS. Again, there's a variety of different ways of doing this whether you're putting a stent in it, you're excising some of the tissue or you're trying to enhance the flow through there.

Um, but they're all targeting the same area of drainage of the eye. Canaloplasty in particular, tries to wash out Schlemm's canal and distal collector channels and thereby, lower the pressure and reduce the risk of glaucomatous damage. Next slide please.

So, what evidence is there for this procedure? Well, there's a variety of studies that show that there is evidence supporting these procedures to help patients have lower pressure and reduce their risk of glaucomatous damage and not all of these studies were referenced in the LCD discussion it could have been in the previous study, but I just wanted to call attention to, in the, in this LCD discussion, the proposed LCD, it references here, it's hard to say which page, because it depends on how you print it, but, um, it shows, when comparing different MIGS procedures, a 2020 systemic review and meta-analysis, including 77 articles, including 28 comparative studies and 12 randomized controlled trials on the available MIGS procedures, the authors report weighted mean intraocular pressure reductions from all analyzed studies where a 15.3% reduction with the Istent, compared to a 36.2% reduction with canaloplasty, and, and yet the Istent is covered by the LCD and canaloplasty is not. And while they're not head-to-head studies showing these compared to each other, the meta-analysis would show that the canaloplasty procedures are non-inferior to the Istent procedures which are covered by the LCD, so it would seem that the science doesn't support this proposed LCD change.

Next slide, please.

So, these are some additional studies that show the impact of, on the canaloplasty on, on patients, and the pressure reduction, resulting from this procedure.

Also, I found that, to help contribute to this area of, uh, information or data, that I published my own results just wanting to increase the amount of data out there. I should say that, in terms of conflicts, I'm not a consultant for any of these companies, I did have a research grant support from Site Sciences which makes the OMNI device when I initiated the, this study.

Again, just to put more information out there for glaucoma practitioners and ophthalmologists who might be using this procedure.

Could we go to the next slide? I think it addresses that study.

Yeah, so this was a study that that, that I published in 2020 and it showed that the mean pressure reduction was 36% with this procedure, again, if we compare that to the Istent in the review published in the LCD, the Istent had a 15.3% reduction, and the OMNI has greater than 30% reduction.

And it just baffles me why the OMNI would not, would be considered investigational when it's being performed roughly 50,000 times a year, and has been for many years and has better outcomes than the Istent, which is which is being covered. Not to say that we shouldn't include the Istent, just that we should not exclude this procedure, which is helping and benefiting so many patients.

Next study please.

Or next slide.

So, in conclusion, the, the OMNI and, I'm sorry, canaloplasty was assigned a Category I code on January 1, 2011, and so there was sufficient evidence at that time to justify a dedicated Category I code, rather than the investigational Category III code, and since then, hundreds of thousands of these procedures have been performed.

And there are a substantial number of studies showing that patients treated with the OMNI canaloplasty procedure, as well as other procedures that perform canaloplasty that it helps reduce pressure, reduce the number of medications that are needed, and is a very effective option when considered with the AAO and AGS Consensus treatment guidelines, the weight of evidence supports Medicare coverage of these procedures to ensure that patients have a variety of alternatives that their surgeon can then help choose what works out best for them. And the other thing that I'd like to point out from the proposed LCD is that I think there's a misunderstanding when comparing the canaloplasty procedure that it is often being compared in the LCD discussion to trabeculectomy, and instead of being compared to other MIGS procedures.

So, so, for example, in the subcategory visco where it says viscocanalostomy, they go phacoviscocanalostomy and ABiC, it says, Trabeculectomy was associated with a significantly lower mean intraocular pressure at 6, 12 and 24 months when compared to viscocanalostomy, and there's no argument there I mean, definitely you know canaloplasty and MIGS procedures in general, do not lower the pressure as much as trabeculectomy or aqueous shunt surgery.

But as some of my colleagues have shown, including those photos, just shown by Dr. Nakatsuka, the, we need a variety of different options, and MIGS are minimally invasive whereas trabeculectomy and aqueous shunt surgery are more invasive and have a higher risk of complications.

And so, we need to have access to these less invasive options, and we're not anticipating that they're going to lower the pressure as much as the more invasive surgeries, on the other hand, we're also not anticipating that they're going to have the level of complications that we see with more invasive surgeries.

And so, I would ask that you please ensure that our Medicare beneficiaries and clinicians in Noridian's jurisdictions continue to have access to all of these effective MIGS options. They help improve patient outcomes. They have created a, an improved toolset in which we can treat patients rather than subjecting them to the higher risk of complications from the filtration surgeries of decades past.

Thank you.

Dr. Eileen Moynihan:
Thank you, Dr. Trayner, and thank you for your time, and also thank you for putting your conflicts in their midway through, because I was going to have to ask you now and that's already taken care of.

So, thank you.

Let's move on to our next speaker, Dr. Mansour.

Khalid Mansour:
Can you hear me?

Dr. Eileen Moynihan:
Yes.

Khalid Mansour:
By the way, I'm not a doctor as much as I'd like to be called one.

Dr. Eileen Moynihan:
We have an MD on there, OK.

Khalid Mansour:
OK. Well, thank you for the time to present, I really appreciate the opportunity.

Also appreciate the prior presentations as a lot of what I wanted to cover was covered very well, but just to re-iterate my name is Khalid Mansour and I'm the President and Chief Operating Officer for the New World Medical. We're a glaucoma Surgical Device Company in Southern California, our flagship products are the Kahook Dual Blade (KDB), OMNI glaucoma valve and OMNI clear path.

Today I would like to share our perspective on the proposed MIGS draft LCD.

I know we have other presenters covering other aspects of the LCD proposal so my presentation will focus on the goniotomy procedure specifically with a Kahook Dual Blade and I'm going to refer to it as KDB moving forward in my slide deck. Next slide, please.

Actually, we can go ahead and skip this slide it's just basic anatomy, stuff that, you know, we can save time on so next slide, please.

I wanted to share a quick overview of the KDB device before getting into the clinical data. Over the past 10 years, we've seen significant innovations to give options and better serve patients and KDB is one of these well studied and well adopted options. Designed to perform a complete excision of the disease trabecular meshwork tissue, providing access from the anterior chamber to the Canal Schlemm and distill collective channels.

This is unlike goniotomies described using an NPR blade or other unsophisticated instruments like bent needles used in some of the studies reference in the proposal.

Next slide, please.

I feel like Dr. Turalba you know, she's stole a lot of my thunder because she made excellent points and covered a lot of the data that I wanted to discuss, but, you know, I'll just re-iterate and expand a little bit on what she said. The draft LCD cited an incomplete evidence for goniotomy which is neither experimental nor investigational.

Goniotomy has been performed to treat glaucoma patients for over 80 years. For KDB, there are over 90 peer reviewed publications in adults on excisional goniotomy, including a level one RCT study that was also referenced. This was not considered in the proposal.

The draft LCD sites only a sliver of the clinical evidence related to goniotomy. The citations include a listing of multiple studies with different goniotomy procedures and devices, the listing shows both the commingling of different procedures and devices also the ages of the references were dated, and this certainly impacted the conclusion drawn by the LCD.

The age of these references are critical considering the KDP device, which is the leading of the segment, was launched in 2015. The body of evidence continues to grow even as we speak today.

The LCD also refers to the lack of RCTs which I will address in the next slide in more detail, and I'll go over this quickly, because after all Dr. Turalba did such a wonderful job discussing it.

But there is the existence of a prospective multi-center, randomized controlled level one evidence study exist and it compares goniotomy with the KDB and Istent implantation at the time of cataract surgery in mild to moderate glaucoma.

I would like to emphasize that the comparator in the study, a trabecular meshwork stents, is covered in the proposed LCD. Results of this level one study were published in one of Oh, I'm sorry. I think we need to advance the slides, yes, please advance.

Yeah, so, to just re-iterate, we were discussing the data on this.

Let me get caught up.

And so, this is a perspective level one study. Results of this study was published were published in one of the most prestigious Journals in one of the most prestigious journals in ophthalmology, the Journal of Cataract and Refractive Surgery.

The study includes 82 open angle glaucoma eyes at each arm, or 164 in total. Procedures were performed across nine clinical practices. The study success definition was, was IOP reduction greater than 20% or medication reduction greater than one. Next slide, please.

Next slide.

There we go.

So, you can see from the results from this study, that investigators found that at 12 months, 94% of the eyes with goniotomy with KDB met the success criteria versus 83% of the Istent arm, the difference in outcome was statistically significant in favor of the KDB. So, in short, the repeated claim and the proposal of the study limitations due to a retrospective nature, lack of randomization, or controls, sample size, et cetera, are simply not correct.

And this error in the analysis is significance. It does exist and the wealth of data in support of goniotomy is significant.

It's also worth mentioning that the KDB has a higher level of evidence data than a stent that would be covered in the proposed LCD, the Istent infinite. There's no RCT data exist for that device.

As mentioned, there are multiple peer reviewed, retrospective publications as well, confirming this conclusion in real-world settings. Next slide, please.

Actually, if you don't mind, we can skip to slide 11. We just put, you know, just to show that the studies that exist, that, we reference the over 92 studies in over 2,000 eyes. So, if you can go to slide 11. That would be appreciated.

One more.

Perfect. Next point is that goniotomy is a well-accepted procedure amongst ophthalmic surgeons and treating adult patients. Looking at the most recent data from Market Scope, a Well Recognized Market research firm in ophthalmology, you see that nearly half of all procedures performed for these patients are non-stent procedures such as goniotomy and canaloplasty, and they have been gaining market share over the years.

An investigational procedure would not have this level of adoption from our respective surgeons who serve the best interests of their patients.

Next slide, please.

And as you've heard from some of the representatives, from some of the societies, there is broad adoption and real-world use at a society level, goniotomy has also received broadly support.

The World Glaucoma Associations, Levitt's Consensus Report on Glaucoma Surgeries recognizes goniotomy with the KDB as an acceptable procedure and states, "KDB can be used stand alone or combined with cataract surgery in early, moderate, or severe open or closed angle glaucoma triggers, IOP, hypertensive medication burden, or both.

You can see that the KDB goniotomy is also accepted by the American Academy of Ophthalmology. I also just wanted to point out that in the Palmetto multi-jurisdictional CAC meeting, that happened in January that the that that was referenced in the LCD, the members were very clear about the need for not only goniotomy but for multiple options to be able to treat this terrible disease. You can see some of those comments here.

Next slide, please.

So, in summary, goniotomy is neither experimental, nor investigational, as demonstrated by the numerous peer reviewed publications.

There is extensive evidence, including a favorable level one RCT study versus the procedure covered by the MAC demonstrating the safety and efficacy of goniotomy with KDB.

This pertinent piece of information was not included in the analysis in the proposed LCD and needs to be considered.

Goniotomy with KDB is performed in accordance with accepted standards for medical practice and supported by the major following societies.

Finally, it's worth to note, a non-coverage decision would actually increase CMS expenditure and the financial burden on Medicare beneficiaries. Not only will this limit doctors and treating their patients but would force them to switch to stents for said patients, which have significantly higher associated fees.

In conclusion, I strongly urge the directors to review the evidence and revise the proposed LCD to include goniotomy in adult patients given the procedures thoroughly documented track record for enhancing the lives of glaucoma patients. Thank you again for this opportunity to present.

And that's it. Thank you.

Dr. Eileen Moynihan:
Thank you very much.

Next speaker, Paul Badawi, are you ready?

Paul Badawi:
Yes, can you hear me?

Dr. Eileen Moynihan:
Yes, I can. Please proceed.

Paul Badawi:
Great, Thank you.

Well, thanks to all of you in the Noridian Medical Policy Unit, for taking the time out of your busy schedules to learn about Site Sciences and our OMNI surgical system glaucoma technology.

My name is Paul Badawi and I'm a co-founder, President and CEO of Site Sciences, therefore, I am an employee and a shareholder.

I started Site Sciences in 2006 with my brother Dr. David Badawi who's an ophthalmologist. Our goal was to develop better treatments for glaucoma.

We wanted to make sure that patients never go blind from this disease.

Over the past decade, we painstakingly researched, developed and created a new technology, the OMNI technology, to facilitate the safest and most effective, minimally invasive surgical procedure for the treatment of glaucoma.

And it has all been worth it.

With OMNI, we have equipped glaucoma surgeons across the country with a better, safer, more comprehensive and more effective surgical glaucoma technology and in so doing, we've made a real impact on the treatment of glaucoma.

Next slide, please.

We've been able to transform how glaucoma is treated by developing technology that is implant free and allows surgeons for the first time to access the entire 360-degree diseased aqueous outflow pathway via an AB Interno approach.

The technology allows surgeons to perform what has been referred to as two sequential and comprehensive outflow procedures, canaloplasty, followed by trabeculotomy. But OMNI does more.

It allows surgeons to address all three sources of resistance in the aqueous outflow pathway.

Surgeons can thereby reduce intraocular pressure and reliance on IOP lowering eye drops, which are difficult to administer and have characteristic peak trough effects that can lead to patients IOP varying significantly over a 24-hour period, which can also affect disease progression.

OMNI is a more complex procedure. It's harder to master and requires training and practice, but it's worth it for the differentiated efficacy it provides.

Next slide, please.

As an innovation and teaching partner to thousands of glaucoma surgeons who use our technology, we're extremely disturbed to see OMNI listed as investigational. We fear this could lead to beneficiaries' and surgeons losing access to this procedure in the Medicare jurisdictions you oversee and disproportionately impact patients with limited financial resources.

OMNI is now a standard of care.

I think that the proposed policy mistakenly discounts OMNI, perhaps because the proposed LCD overlooks several important peer reviewed studies demonstrating OMNIs efficacy.

I expect that when you do a full review of the clinical evidence, your LCD will change and indicate that OMNI is as effective as the stents that are covered under the draft LCD.

Next slide, please.

This slide intends to illustrate where MIGS fits into glaucoma treatment paradigm between daily eyedrops that have their various limitations on the left and more risky and invasive surgery on the right.

For some time, MIGS involves stents and goniotomy and these treatments work for some. But these surgeries target just one of the three sources of outflow resistance, the trabecular meshwork.

Stents and goniotomy do not target Schlemm's canal and the distal collector channels, which are also implicated in glaucoma.

OMNI is the first, and the only technology that enables a procedure that comprehensively treats all three sources of outflow resistance and does so without leaving an implant behind.

For these and other reasons that I will address, the MAC should not eliminate coverage for OMNI Doing so would create a significant treatment gap for patients seeking to avoid permanent implants and more risky glaucoma surgery.

Next slide, please.

Regarding regulatory and medical specialty societies support, the FDA cleared indication for use for OMNI is to lower Intraocular pressure and adults with primary open angle glaucoma.

The FDA expanded OMNIs indication in March of 2021, based on its evaluation of clinical results from our Romeo Multi Center Pivotal Trial.

The American Academy of Ophthalmology identifies OMNI as a MIGS treatment in its preferred practice patterns.

The AAO has never hinted that more evidence was needed to demonstrate the clinical value of OMNI.

Next slide please.

While I appreciate your efforts to assess the clinical evidence for the various MIGS procedures, however, in OMNIs case important, clinical evidence was overlooked in the draft policy.

For example, the one-year results from the Gemini study.

The key point regarding the Gemini study is we model the study protocol, patient criteria, and success endpoints after the three implantable MIGS stents studies that have been used to support coverage for those stents.

Also, only three studies of OMNI were cited in the draft policy, but at least 18 additional peer reviewed papers with 1-to-2-year outcome information have been published. I expect that these additional peer reviewed publications will fill the need for longer term data.

Next slide, please.

Briefly, here, you can see the compelling clinical outcomes from the landmark Gemini trial, in almost 150 patients at 15 sites in the US.

As I mentioned, the prospective multi-center medication washout Gemini Study was modeled after the prospective multi-center, medication washouts stent trials.

The Gemini trial had a pre-specified endpoint and success criteria based on the consistency of the cataract historical control.

The results from Gemini show that OMNI met its success endpoints at 12 months and showed a clinically and statistically significant improvement in IOP lowering and medication reduction beyond that of the cataract surgery alone historical control.

The data is clear. OMNI delivers consistent positive clinical outcomes, lowers IOP 24/7 and reduces the need for IOP lowering medications.

Next slide, please.

I want to highlight here that we see remarkably consistent clinical outcomes with the OMNI technology across all these studies and in everyday practice, similar to the Gemini results.

We believe the comprehensive nature of the OMNI technology is what enables it to perform as good or better than the MIGS implants you intend to cover. Next slide, please.

We've provided a brief summaries of some additional peer reviewed studies involving over 630 patient eyes. Here, within these publications are a variety of clinical data that capture OMNIs broad effectiveness and broad indications for use. Next slide, please.

Here's the continuation of our peer reviewed publications on over 630 eyes treated, and again I would just highlight both the number of studies and the consistency with which positive treatment effects have been identified.

Before closing, I do want to point out that many private insurers cover MIGS and OMNI procedures. For example, CIGNA very recently updated its MIGS policy to cover a canaloplasty to both ABinterno and ABexterno reported with CPT 66174. I don't understand why Medicare is heading in the opposite direction, denying coverage for MIGS.

Medicare beneficiaries should not be deprived of these minimally invasive procedures, especially OMNI and canaloplasty.

I would expect beneficiaries will be outraged if the MACs deny coverage for procedures like OMNI when the majority of private insurers are paying for this procedure. It certainly seems to create a significant disparity in access for Medicare beneficiaries.

Next slide, please.

I'm honored to work with surgeons' that are working to better treat glaucoma and improve the lives of patients who suffer from this blinding disease. From my perspective, there's no greater joy than being in a clinic when a patient returns for his or her post-op checkup. Patients are so relieved when the surgeon tells them that the post-op IOP reductions and medication reductions are even better than expected.

It's so rewarding to see the joy and relief on the patient's face.

It is that feeling that keeps me and everyone at Sight Sciences motivated to continue to provide patients and surgeons with the best technology they need to keep this disease from progressing, and to help them avoid blindness.

Next slide, please.

In closing, we believe the full scope of the clinical evidence and expert input supports the efficacy of the procedure labeled as OMNI.

To ensure Medicare beneficiaries suffering from glaucoma have access to OMNI, we request that the proposed LCD be revised, to recognize that the procedure performed with OMNI.

For example, canaloplasty followed by trabeculotomy is reasonable and necessary to reduce IOP in adults with primary open angle glaucoma.

We intend to continue our discussions with the AAO and CMS involving coding for OMNI.

Thank you all for your time, your interest, and your consideration of our mission and purpose at Site Sciences. Thank you.

Dr. Eileen Moynihan:
Thank you, Mr. Badawi, can I have, oh, is there another speaker, Kari?

Kari DuPreez:
No, there is not, that was all the speakers.

Dr. Eileen Moynihan:
Oh, OK, fine, thank you. Thanks, everybody, for your time.

Um, and please be sure we get, particularly the studies that you want considered, that we get copies of those. If you check the Medicare Program Integrity Manual, Chapter 13, tells you the level of evidence that we have to consider.

So, if you're, if you are going to send those types of studies, we would love to have them, um, case reports, not so much, just individual case reports.

So, because that will be below that level of evidence, we are allowed to consider under 21st Century but, it seems like you have some additional studies for us to consider, and we will be doing that, particularly, after all of the contractors hold their Open Meeting.

So, thanks, again, for your time.

Go ahead, Kari, I'm sorry.

Kari DuPreez:
Alright, in closing, we would like to communicate the next steps in the policy development process. The comment period for the proposed LCDs will remain open until July 29th, 2023. All comments to be considered by our medical directors for the proposed LCDs must be submitted in writing. Written comments can be e-mailed to policydraft@noridian.com, or mailed to the address on your screen. Comment information for our proposed LCDs are located on our website at noridianmedicare.com. Upon review of the comments, our medical directors will either finalize or retire the proposed LCDs. Responses to comments will be viewable in the response to comments articles.

Please monitor our website or register for listserv notifications to be informed of actions taken on our proposed LCDs.

Do any of the CMDs have anything else they would like to say before we end today's meeting?

All right. Hearing none, this does conclude our meeting. Thank you for attending the Noridian Open Public Meeting.