Taylor Canova:
Good afternoon, everyone, and welcome to Noridian's Open Public Meeting. My name is Taylor Canova, and I am one of the medical policy specialists here at Noridian Healthcare Solutions.

We will be presenting the Anterior Segment Intraocular Non-biodegradable Drug-eluting System LCD.

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 to comment on the proposed LCD today. If the comment, if closed captions are needed, please click the more button at the top of your screen, then go to language and speech and show live captions. Also, a visual of these steps is located on this slide.

For presenters, you are being allotted 10 minutes to make comments. Your line will be open 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 moderator's voice when one-minute remains. If you reach the end of your 10-minute time limit, your line will be muted, and we will move on to the next speaker in order to allow all registered commenters time for their presentations. Please speak clearly to ensure the system will be able to translate into captions for display.

And as I have mentioned, the recording and transcript will be posted to our website. So 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 be submitted in writing, and all written comments received will be recorded in the Response to Comments article. And I see everyone has a slideshow presentation, and if you could just let the moderator also know when it is time to advance the slide.

I will now turn this meeting over to Dr. Eileen Moynihan. Dr. Moynihan, you may begin.

Dr. Eileen Moynihan:
Hi, everybody. I'm Eileen Moynihan, one of the Medical Directors for Noridian Healthcare Solutions. Thank you all for coming today, those of you who are speaking and those of you who are listening. To echo what Taylor already said, we would like everything in writing after speaking, that would be great. And for those of you online, definitely remember that peer-reviewed articles are welcomed.

Also, if you do not make this meeting, as long as you make your comments to one of the contractors who still has a comment period beyond ours, you can also do that as well. Only one contractor needs to receive them since this is a multi-contractor effort. Okay, with that, let's move on to the first speaker. Dr. Steve Mansberger, would you like to go ahead, please?

Dr. Steven Mansberger:
Can you hear me okay?

Dr. Eileen Moynihan:
I can.

Dr. Steven Mansberger:
Yes, I'm glad it worked. Okay, I had to re-log in just using the web browser.

Well, first of all, thank you for allowing us to talk about this anterior chamber sustained delivery system. As you know, sustained delivery is used in many fields of medicine, such as OB-GYN and psychiatric treatment and they've really revolutionized how they treat those conditions, and we think it has a lot of promise for glaucoma as well.

We can go to the next slide.

I have no conflicts.

We can go to the next slide. And we can go to the next slide.

So just from a broad perspective, we wanted to kind of talk about a couple things about the LCD and we appreciate that the FDA has approved this system, but we think that the provisions right now might exceed the evidence base. This technology is very, very new. It has not been used in that many patients, and so we're still trying to understand where it fits within the armamentarium. And so we think that several provisions in the proposed LCD may go beyond the currently available evidence and could unintentionally limit our flexibility and patient access. And, you know, it has a risk of unintended, you know, barriers to trying this treatment out. See how it works in the marketplace and then refining how we use it.

Next slide.

So just kind of going along with what I already said, there's limited long-term outcomes and experience with this medicine. And without that clinical experience, we risk that the policy will outpace the evolving evidence. And we think it's premature to develop an LCD yet for this device, which is currently the only product in the market to this LCD would apply. And we do need long-term data on glaucoma progression and monitoring, especially for some safety endpoints with the corneal endothelium. And ophthalmologists are still trying to decide how best to use this treatment. And there are some studies that are in process to help with answering these questions about safety and efficacy. In the meantime, we recommend that we rescind or postpone the proposed LCD and pause that until clinical data is available and then adjudicate claims on a case-by-case basis. If we don't rescind it, we think that there's going to be significant revisions needed.

Next slide.

So one of the provisions in the LCD is about Step Therapy, and we believe it's too restrictive. Currently, I think it says that you need to have failure of two agents, but there's really no rationale for that description in the literature. It's not possible for all patients to be on two medicines, and it may not really reflect real-world care. There's also the requirement for selective laser trabeculoplasty, or SLT. And SLT is not feasible for all patients, and there's some reasons listed there. So we think that the current requirements are too restrictive.

Next slide.

So a patient has failed two drops and an SLT is less likely also to benefit from an anterior segment sustained delivery system. If we are going to change the LCD, we would recommend that it goes from two drops to one drop. We also recommend the change of criteria from both needing two drops "and" SLT to just "or" for one drop or SLT. And there's also some issues with preservatives with using two drops. SLT is known to not work as well when patients have had multiple different drops on board. So there is a scientific rationale for using this device in an earlier way.

Next slide.

There also is a limitation in the LCD with using this at the time of cataract surgery, but it's expected that the that the iDose TR would be complementary. They work in different ways in which they lower pressure. And so when you're already going in there to do cataract surgery, providing the iDose TR could be a benefit to the patient and ease the burden that they would have with chronic eye drop treatment. And right now, there's only three-month data, and we understand that additional data will be available in 2027. And we recommend, you know, removing that limitation about not doing it at the time of cataract surgery and consider it on a case-by-case basis, and then revisit the policy as more literature becomes available.

Next slide.

Reference 14 states that it's, you know, not recommended to re-administer an iDose more than once a year. We believe that there might be a potential typo in the time requirement that states that two years must elapse prior to re-implantation. The reference for this limitation is number 14. And we agree not once, not more than once per year. So we recommend a correction to limitation 3 to clarify the frequency limitation to one, not two years.

Next slide.

Any intercameral medicine for sustained delivery has a possible effect on endothelial cell count. And right now, the recommendation is use specular microscopy. This tool is a special camera for taking images of the endothelial cells. It's not widely available. It's mostly used in corneal practices or in research. So that creates a little bit of a, creates a barrier for usage of this medicine. So it's a more strict requirement than we think is required. And we could also assess corneal health using a slit lamp exam or corneal thickness measurements via pachymetry. So we recommend that revise limitation 4 to allow slit lamp examination and corneal pachymetry. And we think endothelial cell density, you know, is important, but is not available and could be used in which these first tests seem like they're showing that there might be an issue with the endothelial cells.

Next slide.

So when these requirements are taken together, they create a high threshold for access for patients for this technology, and they really limit our ability to understand how this will affect clinical care. And it will delay treatment and limit access to care for some patients. And this is particularly important for glaucoma that requires chronic care over many years, sometimes a decade or more. So we feel like this is a large impact.

Next slide.

Taylor Canova:
One minute.

Dr. Steven Mansberger:
So our recommended path forward is to rescind the proposed LCD and pause development until more outcome data are available and adjudicate claims for this technology on a case-by-case basis. We want to increase the flexibility in the Step Therapy from instead of two drops, just one drop, and changing from both requiring drops "and" laser to "or".

We want to remove, we recommend removing the limitation for not performing it at the time of cataract surgery because it's a time that you're already in there doing surgery and they work in different ways, and we should have some more data about this in the future. And we consider revising limitation number 4 to allow clinically approached assessment methods of corneal health and correct limitation number 3 to reflect a one year reimplementation limit.

Thank you.

Eileen Moynihan:
Thank you very much for your comments. I'd like to move on to Dr. Nguyen.

Dr. Quang Nguyen:
Good afternoon, Doctor Moynihan. Can you hear me?

Eileen Moynihan:
I can hear you.

Dr. Quang Nguyen:
Perfect.

Good afternoon. My name is Dr. Quang Nguyen, thank you for the opportunity to speak to you today. I'm an ophthalmologist in San Diego, California, with clinical and surgical practice focusing on glaucoma and anterior segment surgery, which includes cataract and glaucoma surgery. My expertise lies in the fact that I have been treating thousands of ocular hypertension patients and open-angle glaucoma patients over the past 27 years. I care for Medicare beneficiaries with glaucoma every day. Patients with ocular hypertension to early glaucoma, to advanced glaucoma, and patients already losing functional vision from a disease that is chronic, progressive, and irreversible.

My request is not unrestricted use of the travoprost intracameral implant for every patient. My request is that the LCD preserve physician-directed flexibility when topical therapy, selective laser trabeculoplasty, or stage surgery is not the right pathway for an individual Medicare beneficiary.

Next slide, please.

My disclosure, I've worked with numerous companies throughout my career in the eye care space, those I believe that technology and how it can benefit my patients in glaucoma and preserve their vision.

Next slide, please.

So I'm here because the proposed LCD as written risks restricting access to a therapy that addresses one of the central failure in glaucoma care. Not whether medication can lower intraocal pressure under ideal conditions, but whether that therapy is actually delivered reliably in real life.

Slide four, please. Next slide.

So, this slide focuses on topical drop reliability and adherence, and I think this is the heart of the problem. The proposed LCD requires failed medical management with at least two topical medications unless the patient meets narrow exceptions, but the real-world problem is not limited to a patient who is physically incapable of placing any drops. There's a much larger group who can technically place a drop, but cannot do so reliably enough, consistently enough, and comfortably enough over the years to preserve vision.

The collaborative initial glaucoma treatment study, the CIGTS study, adherence analysis highlight this relevancy. The CIGTS study was a landmark glaucoma clinical trial and later analysis connected medication adherence with functional vision outcome. First report, patients who reported never missing doses had only modest visual field loss over time. Patient who misses dose more frequently had much greater loss, including more than two decibels of mean deviation loss in the least adherent group. So for those non-ophthalmologists in the audience, mean deviation is a standard measure of visual field damage. More loss in DB means more functional peripheral vision loss. In glaucoma, mistreatment does not simply cause temporary symptoms. It can mean permanent ganglion cell loss, permanent optic neuropathy, and permanent visual field loss.

That is why I'm concerned about the forced sequential failure. If a patient pressure is above gold on a prescribed topical prostaglandin, why did this happen? Well, it may be true that the pharmacologic is non-responsive, but it also may be missed doses, poor installations, pharmacy access, side effects, cost, confusion, or wash out from placing multiple drops back-to-back. In that circumstance, requiring a second topical failure may not produce better evidence. It may simply repeat the same flawed experiments while the optic nerve remains at risk for damage. A patient who cannot reliably use topical prostaglandin therapy has not proven that prostaglandin therapy is inappropriate; that patient has proven that topical delivery is unreliable.

Next slide, slide 5, please.

Topical medication and Selective Laser Trabeculoplasty, or SLT, or established first-line treatment. SLT is an office-based laser procedure intended to improve aqueous fluid outflow through the eye's natural drainage tissue, the trabecular meshwork. I use both drops and SLT every day. I recommend SLT, just like a lot of my colleagues on this call, frequently. I prescribe topical medication constantly. This is not an argument against drops or against SLT, but accepted first-line options should not become a rigid sequence that every patient must fail before another reasonable and necessary therapy can be covered.

SLT is an excellent therapy. It is supported by the LiGHT trial, which stands for the Laser in Glaucoma and Ocular Hypertension. LiGHT was a major randomized trial supporting SLT as an effective first-line option. SLT is also supported by the 2024 American Academy of Ophthalmology Ophthalmic Technology Assessment, which review the evidence and describe SLT as a primary replacement or adjunctive therapy. That language supports flexibility. It does not support converting SLT into a compulsory gait before a therapy with a different mechanism and a different clinical purposes.

Drops, SLT, and sustained release intracameral travoprosts are not interchangeable. Drops provide pharmacologic IOP reduction, but dependent on patient's behavior. SLT provides adherence independent intraocular pressure reduction, but depends on biological response to the trabecular meshwork outflow pathway and has variable durability due to the individual biology. The travoprost intracameral implant provides sustained prostaglandin therapy without administrations. Those therapies solve different problems. The proposed LCD appears to ask, has the patient failed drops, then failed SLT? I believe the better Medicare question is, is this therapy reasonable and necessary for this patient, given disease severity, adherence, risk for adherence, ocular surface status, target pressure, and physician's judgment?

Slide six, please.

I also want to address the proposed restriction on combining iDose with other glaucoma procedures, including MIGS. MIGS stands for Minimally Invasive Glaucoma Surgery. These are procedures intended to lower eye pressure by improving aqueous fluid outflow, often to the trabecular meshwork or other drainage pathways.

I believe the combination restriction. iDose is not a MIG procedure. It is a procedure of pharmaceutical delivery system. It delivers sustained prostaglandin therapy. A MIGS procedure, by contrast, is intended to improve aqueous outflow through a surgical or device-based modification of the outflow pathway. Treating these as stacked, duplicative, or unnecessary procedures misunderstands the clinical strategy. They are not redundant. They are complementary. In glaucoma care, we often need to address more than one mechanism at the same time. Medication delivery, trabecular outflow, medication burden, and patients' ability to maintain treatment over time.

Combining a sustained-release prostaglandin implants with MIGS may be clinically rational precisely because the mechanism are different and potentially synergistic. MIGS may improve outflow of the patient's daily adherence and independent of whether the MIGS response is robust. That distinction is critical, in my opinion. If a patient undergoes a MIGS procedure and the physiologic response is inadequate, a combined iDose approach means that the patient has still received sustained prostaglandin therapy at the same surgical setting. Without that flexibility by the clinician, the patient may need to return for a second procedure with additional anesthesia exposure, additional recovery, additional claims, additional burdens on the family, and additional time before reliable intraocular pressure control is achievable.

So the combination argument is not about doing more procedure for its own sake. It is about avoiding fragmented care. It is about using one surgical encounter to address complementary mechanism and reduce the chance of the patient leaves the operating room dependent on a single physiologic response that may not be sufficient. I'm not asking for indiscriminate combination surgery. I'm asking that the LCD not categorically prohibit physician judgment when combining iDose with MIGS is medically reasonable for an individual patient. Glaucoma is a lifelong treatment. A patient may require therapy for years or decades. If our policy framework assumes that chronic topical therapy is always the required starting point, and that non-topical frequency therapy should only come after repeated failure, we may be prioritizing historical sequence over real-world outcome.

Taylor Canova:
One minute.

Dr. Quang Nguyen:
Next slide, please. Slide seven.

I recognize that this is an intraocular procedure. It has risk, endothelial safety has been addressed by a recent HORIZON trial, which shows the phaco group, cataract surgery group combined with the [inaudible] but this is modern cataract surgery. So for that reason, I'm not asking Medicare to ignore these safeguards. I'm asking the safeguard to be clinically grounded and not convert it into a premature restriction.

Slide eight, please. We can skip this one, I think, Doctor.

So summary of key concerns, Step Therapy. We're asking "and" "or". We talked about combination surgery, follow-up reality, specular microscopy, and re-administration.

And the last slide, please.

So my request today is practical. Please revise the LCD so that the coverage is not limited to patients who have failed multiple drops and failed SLT in a rigid sequence. Broaden the topical medication criterion to recognize adherence risk, medication burden, ocular surface disease, intolerance, and cost barrier. Do not make failed SLT mandatory in every case, and do not categorically prohibit combination with MIGS when the physician determines that the complementary mechanisms are appropriate for the patients.

Thank you for your time and for the opportunity to comment.

Dr. Eileen Moynihan:
Thank you very much, too.

I'd like to move on to Dr. Kramer. Dr. Kramer, are you able to speak?

Dr. Brent Kramer:
There you go. Can you hear me now?

Dr. Eileen Moynihan:
I can, yes.

Dr. Brent Kramer:
Awesome. Hey, thanks for having me. Thanks for hopping on everybody.

My name is Brent Kramer. I'm an ophthalmologist with Vance Thompson Vision. I primarily practice in Sioux Falls, South Dakota. My clinical practice primarily focuses on cataract and intersegment surgery. I'm actually fellowship trained in cornea, but I care for, you know, lots of Medicare beneficiaries, and a lot of those patients have glaucoma. And so I address glaucoma even as a cornea doctor every week in the clinic and in the OR.

And so I want to begin by saying that I share the goal for this draft LCD. We all want patients treated safely. We want sound evidence with appropriate stewardship to Medicare resources. My comments today are offered in that spirit. My focus is narrow but important. I'm going to stay in my lane and talk mostly about the cornea recommendations.

You can go to the next slide.

I do have some disclosures here. Glaukos being one, I know we're talking about the iDose today.

Next up, or next slide. Awesome.

So there's four reasons I believe the draft needs to be revised before finalized. First, the evidence in the space is still maturing. The iDose TR is a relatively new therapy and the post-market literature is actively evolving. A coverage policy written tightly around today's data might not age well, and it may foreclose patient access in ways that the evidence does not actually require.

Second, the draft is inconsistent [inaudible] pattern. A requiring documented failure of medication and then failure of SLT before iDose can be offered is not supported by the academy's PPP and is not clinically warranted for every patient. Third, restrictive step therapy widens health disparities. It is disproportionately affects elderly patients, lower income patients, black and Hispanic patients, and patients who simply can't reliably self-administer drops. These are the patients we're trying to take care of with iDose. The patients who have progressive glaucoma can't put their drops in and, you know, need this device and this drug. You know, whether that's because of arthritis, a tremor, cognitive impairment, limited caregiver support. In rural states like South Dakota, where I'm from, those aren't educations, that's every day. Those are the patients I see every day. And fourth, several specific elements of the draft apart from the FDA prescribing information and from the randomized control trials that support that evidence. So that is what I want to focus on.

Next slide. Great.

So taken together, my recommendation is respectful but clear. I would ask the committee to decline to finalize the draft in its current form. The clinical inequity concerns are substantial. Step therapy interferes with individualized care. The evidence cited does not support the level of restriction proposed prohibiting concomitant procedures overlooks the real benefit of combination therapy at a single surgical encounter, and the re-administration restrictions are inconsistent with prescribing information.

All right. I'm going to focus a little bit more on the cell density requirement. In my judgment, the ECD language as written will impede patient access without corresponding safety gain. It misclassifies iDose TR as a device when the FDA label frames ECD in the context of re-administration safety. It does not account for the documented inability of many patients to instill drops reliably, and it diminishes clinician flexibility in exactly the situations where flexibility matters most. We're just trying to take care of folks and preserve vision from one of the leading thieves of vision, which is glaucoma.

Next slide. Great.

The draft language reads, quote, pre-implementation, the patient's central corneal endothelial cell density must be at or above the FDA label recommended minimum. The problem with this is that the FDA label does not establish a universal pre-implanted, pre-implantation ECD gait. It describes endothelial cell density in the context of re-administration safety. So converting that into a hard pre-implant requirement for every patient creates confusion at the point of care. It impedes access, and it does so without a demonstrated safety benefit.

Next slide. Next slide. Good.

There are four specific reasons why I would recommend changing this specular microscopy requirement.

First, the label intent does not equal a universal gait. The FDA described ECD in the context of safe re-administration. It does not require specular microscopy before every initial implant.

Second, specular microscopy is not universally available. This is really important to understand. It is not common for most ophthalmologists or glaucoma specialists even to have specular microscopy. I have one in my practice and it's not even because I'm a cornea specialist. It is because we participated in FDA clinical trials. And so honestly, as a cornea specialist, I do not utilize this in my clinic day to day. And so even someone practicing at the very tip of the spear in cornea, without my involvement in clinical trials, I don't even know if I'd have this device. And it's also tough to get your hands on. We have sites right now that are trying to become more involved with clinical trials, and they are unable to get specular microscopy just because it's a device that's not widely available. So even doctors who want to get this are having a hard time getting it. So it is not common in community practices. And so you're mostly finding this at, you know, academic centers or places that are doing clinical trials. And so that will widen the healthcare disparity here to patients that are, you know, able to go to these tertiary care centers.

So, third, mandating specular microscopy widens inequity, like I was saying. If access to a covered therapy depends on access to a piece of equipment that many practices don't even own, we've effectively limited the iDose to patients who can travel to a tertiary care center. And that's not a neutral policy. That's going to limit care to probably, and frankly, the people who need this the most.

Fourth, corneal health has many invalid measures. Specular necroscopy is one method. And so I'm the cornea guy. We absolutely need to be looking at the cornea when we're making these clinical decisions. But oftentimes it's just that, it's a clinical observation made by the doctor. We are looking for things like guttata on exam every time.

We can easily get something called a pachymetry, or the thickness of a cornea to assess corneal health. But frankly, it's mostly just a slit lamp exam by someone who had trained for four years to look at corneas, which is every ophthalmologist, so I think that limiting this to, you know, just saying that the cornea needs to be in health, which is what the FDA label has, is going to be the most important part here.

Next slide.

So I would respectfully ask that the committee to delete the current draft language on ECD and replace it with the following: re-administration requires physician documentation of corneal health consistent with parameters supporting continued safe use as determined by the treating ophthalmologist using clinically appropriate methods, specular microscopy being one accepted method, but other methods providing equal information are also available. This language is faithful to the FDA label. It preserves the safety check where the label actually places it at re-administration, and it allows that treating physician to use the tools available in their practice to best suit them and best suit their patients.

Next slide.

A couple other issues. We've talked about this a little bit, but the two years versus one year. The FDA label says one year after reimplementation the iDose can be reimplanted. I would recommend that we stick with FDA's, the agency's recommendation on that.

Next slide.

And I would, yes, this is just the implant cannot be re-administered within one year of previous insertion, consistent again with the agency's prescribing information.

Next slide.

So in closing, three points that I hope the committee takes into consideration. First, and, you know, the part that I talked about the most is the endothelial cell density is a re-administration safety check, not needing to be done prior to the initial surgery. And it is also important to not require the specular microscopy. So second, not requiring specular microscopy. That's just going to create a lot of barriers to care and really prevent the people that need this the most from getting it. And third, we recommend that we preserve physician judgment and clinical flexibility on this. You know, as doctors and surgeons, we are just trying to take the best care of our patients. And so this creates a huge barrier and ultimately, these barriers are handed down and really affect the people that need treatments like this the most.

So I appreciate the work that has gone into this draft. I really appreciate the committee's willingness to consider revisions. My request is practical. Align the ECD language with the FDA label, align the re-administration interval with the FDA label, and then protect access for Medicare beneficiaries who depend on this therapy the most.

Thanks everybody. And again, thanks for taking the time. I really appreciate it.

Dr. Eileen Moynihan:
Thank you very much for your comments.

Dr. Bacharach.

Dr. Jason Bacharach:
Well, good afternoon. Thank you for allowing me to provide input on this very important draft that has significant ramifications for many of my patients.

I'm a fellowship-trained glaucoma specialist. I think I'm the senior guy here on this call. I've been in practice 33 years caring for geriatrics, and these are primarily Medicare beneficiaries with glaucoma. I train residents. I run the glaucoma division at a teaching hospital in San Francisco, providing care to underserved communities, and we're primarily funded through the Lion's Eye Foundation. My private practice is in rural Sonoma County. It's an important agricultural hub of California and our country. Out of disclosure, for disclosure, I do conduct clinical research for the past 30 years. I've been an investigator for most of the drops on the US market, as well as all of the drug delivery technologies, including the travoprost intracameral implant. Academically, I'm an active member of the Glaucoma Subcommittee of the American Society of Cataract and Refractive Surgery, and I'm the past chair of the Glaucoma Section of the American Academy of Ophthalmology Knowledge-Based Assessment Panel.

And I'm really here to talk about two specific parts of the LCD that affects my patients and how I practice. And that's the two medication and prior SLT prerequisite for patients to get the intracameral implant.

Slide two.

When I started Practice 33 [inaudible] we had ultimately the MIGS, minimally invasive surgery. As I tell my residents, this is a great time right now to [inaudible] risk of blindness or functional vision loss. And just a reminder that glaucoma doesn't only affect vision, it has other ramifications, higher hip fraction rates, clinical depression, and these are all considerations in the management.

Slide three.

This population tends to be on multiple medications for multiple systemic conditions and getting them to take just one drop a day is a challenge. And multiple studies, as you heard earlier, demonstrate a business. The glaucoma adherence persistency study, called the GAP study, that was published by Riordan in the American Journal of Ophthalmology showed that 50% of patients only in the first year fall off therapy. And the worst part, doctors had no better than, were no better than chance at identifying who those patients were. Why is this? You heard some of the reasons: costs. My patients can't even afford generics these days sometimes. The asymptomatic disease that this is in many cases, the denial. Comorbidities, as you heard earlier, Parkinson, Alzheimer's, arthritis. Look at YouTube. You'll see people putting drops in on their cheeks, et cetera. It's kind of funny, but really it's not. Adherence issues are really common with chronic diseases. As many of you know, as primary care physicians and other subspecialists, hypertension, diabetes, just like the disease we manage.

Next slide.

Management [inaudible] changing. Adding medications can be bad. It can be a dangerous cycle. Studies by, really legends in our field like George Spaeth at Wills Eye Hospital in Philadelphia and many others, clearly demonstrate that adherence issues occur the more drops that are applied. They get worse. And the worse the cycle gets, the more irreversible vision occurs. I heard my colleague Quang Nguyen talk about one study that clearly demonstrated that. The cost of the system rises as the disease progresses, as we do more invasive procedures that are needed and managing low vision needs. Very expensive. So this new paradigm of MIDS, I coined that word or term, minimal installation drop strategy, it improves compliance, it reduces side effects from the benzalkonium chloride that nearly 80% of drops and almost all generics have, the cumulative negative effects on not only the ocular surface, but the trabecular meshwork itself. It also increases cataract progression using drops. We saw that in the ocular hypertensive treatment trial. And by far, the second most common class is the beta blocker. Many patients on systemic beta blockers, or asthma, or chronic obstructive pulmonary disease, or even cardiac issues still end up on it as a second drop. It can even worsen the disease in people with normal tension glaucoma. It can reduce perfusion, and that makes up one in five people with open angle glaucoma. And as we heard from Dr. Nguyen, the collaborative initial glaucoma treatment study by Paul Lichter and colleagues, a non-industry sponsored study, one of our landmark studies. They compared drops to surgical procedures and management, while in that drop swing, the direct correlation between adherence and vision loss was clear. The more patients missed the drops, the more visual field damage occurred.

Next slide.

Adding a third or fourth drop. It's really not even taught. Nobody offers that to patients anymore. Adding medicines has a law of diminishing returns. That's why in the United States, we don't have a fixed combination with a beta blocker and a prostaglandin. The combinations were not able to meet superiority over the individual components alone. So, I'm really happy to be able to have the option of linking drug delivery to SLT. That dual effect by improving the conventional outflow with the laser, and then that 24-hour control with a prostaglandin being delivered in the anterior chamber affecting the uveoscleral outflow. It's been a game changer. We know that. We have the data. Professor Weinrab from UCST clearly demonstrated that both prostaglandins and SLT lower the pressure over 24 hours.

Slide six. Next slide, please.

So, if you're a baseball fan [inaudible]. We can't get the great [inaudible] approximately half the [inaudible] therapy but adding drops hasn't been a good strategy. These are just some of the data points that you see here of landmark trials supporting that contention.

Think about this in your decision-making process.

In the travoprost intracameral implant trial, the control wing had timel [inaudible]. Over the course of 36 months, in just one eye, a patient got 2 [inaudible] 190 [inaudible]. That is impossible for any one of us on this call to do, let alone my 80- and 90-year-old patients that are taking five or six oral medicines a day.

Next slide.

So we have better tools now. We're one of the last subspecialties, as Dr. Mansberger, who spoke earlier said, that has drug delivery, cataract, corneal management, especially our retinal colleagues, which manage a very analogous disease. Drug delivery is in full blossom in our space and outside of our space.

And our final slide, next slide, please.

So in conclusion, I really do urge you to allow us the flexibility to do our job caring for these seniors. It would be so much easier and honestly so much more cost effective to the system to make this minor adjustment to the LCD draft: A trial of one medicine or a failure of SLT. It makes total sense. Try a prostaglandin drop. If it works, great. If there's compliance issues, consider SLT or consider drug delivery. If a patient has SLT and it wears off, or they're not a candidate for SLT and they're not a candidate for drops due to, let's say, arthritis, consider the intracameral travoprost implant.

Thank you so much for allowing me to speak. I appreciate being on this call with all of you as well as my esteemed colleagues.

Dr. Eileen Moynihan:
Thank you very much for your time.

Dr. Simpson.

Dr. Rachel Simpson:
Hi, everyone. It's morning where I am. I'm actually logging in from Hawaii. I'm here with my two kids. So thank you so much. I do feel like this issue is important enough to me and more specifically to my patients that it is worth logging in on vacation and being able to advocate for my patients and on their behalf.

Just some background, I am a fellowship trained glaucoma specialist at the Moran Eye Center, where I also serve as our residency program director and the vice chair of education. I'm going to focus specifically my comments more on the mandatory SLT first requirement, but I also, I'm going to start really, you know, the last four speakers have done such an amazing job of talking about the science behind what we're asking. I want to take a few minutes and just talk about how this actually will impact me and my ability to treat my patients.

Next slide, please.

These are my disclosures.

Next slide, please.

So I think most importantly, I think it's important that we recognize that really Step Therapy with glaucoma is an antiquated paradigm. It is applying 20th century medical practices to the practice of medicine in the 21st century, where we have dramatically improved tools to be able to treat our patients. And it's essentially saying the way we were doing things 30 or 40 years ago is still the best way, and I think fundamentally as doctors, we all just know that is not the truth. We are not saying everyone has to get a CABG before they can then get a stent. Intuitively, we all know that the development of these drug-eluting stents in cardiovascular disease is a huge step forward. With biologics, you know, we're not saying you have to treat everyone with steroids, and if the steroids don't work, you have to treat everyone with stronger dose steroids before we can move on to the biologics. We're recognizing that these are dramatic improvements in how we treat patients and that patient outcomes are so much better because of it.

We also have to recognize that Step Therapy delays treatment, just fundamentally for my patients. I have patients who drive, you know, I'm based in Salt Lake City, but I see patients from Wyoming, Idaho, Montana, Nevada, Arizona, New Mexico. Patients are routinely driving at least six hours to come and see me for every appointment.

And so if I'm adding and taking off medication after medication to try and find one that works and try and figure out, you know, are you having, is this a bad reaction? Is this your dry eye? And then we move on to SLT, that potentially for my patients is almost a year of going back and forth between me and Salt Lake City and their home in Montana.

And all of the money that they are spending to try and kind of be able to come in and take care of their disease, that is a huge burden that we're placing on these patients. And then you have to remember these patients already have vision loss. They're elderly. They are almost always lower income. They're limited with mobility. They often have mentation limitations. Glaucoma just disproportionately impacts these people who are already lower, higher vulnerability to bad things happening from their disease, who have a harder time getting to appointments, have a harder time driving. And then we're placing these increasing burdens on them, being able to get the care they need to stop their vision loss.

Next slide, please.

I think it's also important to remember that this technology really does represent a transformative breakthrough in how we treat glaucoma. This is the first device of its kind that allows us to deliver medication that we know works directly to the tissue that needs it. We are now bypassing the surface of the eye, which means all of these side effects that my patients experience from the administration of drops and preservatives that are in that drops that make those drops toxic acutely and also over time. We can eliminate that.

I also spend time at the VA, and I have to tell you, the number of patients that this has been a godsend for is tremendous because we do have so many patients with mentation and mobility limitations that really makes the administration of drops difficult.

I live in Utah, a state that is afflicted by tremendous amounts of dry eye, where these drops make it significantly worse. And even though dry eye might sound benign, I have patients who are 2100 or 2200 because their cornea is so destroyed by chronic administration of drops. I'm not talking about, you know, over six months, but they've been on these drops for 20, 30, 40 years, and they just don't have the ability to lubricate their corneas anymore. There are long-term implications to being on these drops for a long period of time that we're not able to really see in just, you know, a year or two years. So this really does represent a massive step backward in our ability to treat glaucoma.

Next slide, please.

Again, we've talked a little bit about why mandated medical sequencing is an old-world approach to a new technology and our ability to treat glaucoma. Specifically, the delay in care that can result in irreversible nerve damage and vision loss. We have to remember that once those nerve fibers are dead, we cannot get them back. And so time really is, you know, time is brain, if you're having a stroke. Time is nerve, and when we're talking about glaucoma. And these delays that are going to be added to the treatment of glaucoma are really going to have significant outcomes in our patients' functional vision. And I think it's really important to keep that in mind and again, that we're most impacting the people who can least afford to be impacted when we're talking about these restrictions.

Next slide, please.

Specifically, with SLT, SLT is a laser treatment that is done in clinic that is designed to improve the outflow of fluid through the trabecular meshwork inside the eye. It has traditionally, you know, last century was thought of as a last line device, and what we're learning, of course, is that we really need to revise our treatment models. And so SLT is being done sooner and is hopefully moving more and more to a first-line treatment.

But not every patient is eligible for SLT. There are many, many types of glaucoma where SLT is contraindicated. Uveitic glaucoma, inflammatory glaucoma, neovascular glaucoma, traumatic glaucoma, just to name a few off the top of my head. And then once you get beyond that, there are a number of patients who simply can't tolerate or are unwilling to have a laser treatment done to their eye. We also have to keep in mind that patients can have successful SLT and still need better IOP control. SLT gets us part of the way there, but it is frequently not the only thing needed. They need SLT and something else.

And of course, the definition of success is arbitrary and subjective. How long do we have to prove success? Some people are successful on SLT for six months. Some people are successful for 10 years. You know, what are we defining success as clinically is going to change based on the patient because glaucoma is such a subjective patient dependent disease. There is not one treatment algorithm that we can apply to every patient. Every single patient requires a tailored approach.

And then of course, the time and travel burden for SLT is very real. For me just to have the SLT, it is four separate individual appointments and at least three months per eye to access success rate. So then you count that these are people who have trouble getting rides. These are people who are visually impaired already. They might be coming from 12 hours away to come and see me. And I tell them, we have to do this before I can give you a device that I actually know is going to help you immediately, but these are the boxes and the hurdles that we have to overcome to be able to get you there. It does become a huge burden to being able to treat the patients.

Next slide, please.

Again, as we talked about, SLT is contraindicated, inappropriate, or infeasible for so many different types of glaucoma. And we know that the results really are highly variable. The failure rates are as high as 72% or 77%, depending on the studies that you're looking at. So as much as we like SLT as a first or second line treatment, it is also still not going to be enough for the vast majority, specifically my patients who have severe glaucoma and also my patients who, at least in Utah where nobody has any vices, are living to be 99 or 100. And I have to keep them seeing from, you know, age 60 to age 100, I need every single tool that I have in the toolbox to be able to do that.

Next slide, please.

We also are increasingly gaining knowledge that SLT and the travoprost in the device have a complementary mechanism of action. So if you think about how we know SLT works on the trabecular meshwork, which we consider the conventional outflow pathway, and then we consider that the travoprost in the iDose TR functions on an entirely separate pathway. We know that the whole is greater than the sum of its parts when we're able to access both of those pathways. There is an additive effect of being able to optimize outflow through the conventional pathway and optimize outflow through the uveoscleral pathway. So the IOP lowering effect that I could potentially get from treating someone as a targeted combination therapy of giving them SLT and then placing an iDose as a planned treatment for their glaucoma is synergistic. And we think that that dual mechanism approach is actually going to get us better results than when we do them separated or isolated and so it really is kind of missing an opportunity to have even more impact when we're treating our patients. And really, we should be deciding to use iDose independent of SLT success or failure, but there is an opportunity for us to maximize the success of both by using them targeted and strategically.

Next slide, please.

Taylor Canova:
One minute.

Dr. Rachel Simpson:
Finally, AAO practice patterns prefer an individualized approach. And we've already established glaucoma is an individualized disease. How it varies from patient to patient and their very specific conditions, what you know, how much money they have, whether they can afford their drops, their mobility, their mentation. First of all, none of that is static. It's all changing over their lifetime, and this is a lifelong disease. So it is important that we are able to tailor our treatment to the individualized patient.

Next slide, please.

So what we are asking is some recommended changes to the language. There are actually several that would probably be improvement over what we have currently, which is the failed history of SLT as mandated. So option one would be trying at least one topical medication or SLT, one or the other and not both. Option two would be trying one medication or previous document of SLT, but they don't have to necessarily have failed SLT. And then even better would be to try at least one topical medication with evidence of further non-compliance and take the SLT out of it. We love SLT, but it should not be mandated for any patient. That is really a patient-doctor decision. And so we should take the SLT requirement completely off the board if possible.

Next slide, please.

And that's all I have. Thank you so much for letting me be here.

Dr. Eileen Moynihan:
Well, thank you very much for your time, especially taking time out of your vacation in Hawaii. I'm not sure I would have done that but thank you. Thank you very much for your comments. I'll move on to Dr. Funke.

Dr. Rachel Simpson:
My pleasure.

Dr. Christine Funke:
Good morning. Oh, I'm morning too. Yeah, like Rachel, I'm actually in Australia calling in, so it's 5 A.M. here.

Dr. Eileen Moynihan:
I need to improve my lifestyle here. Do you mind sending me some brochures of where you're all going?

Dr. Christine Funke:
Sure. You ready for me?

Dr. Eileen Moynihan:
I am, sorry for that.

Dr. Christine Funke:
Oh, no, no, it's great. It's always nice. We're all humans and always in need of a trip somewhere else.

So I'm Christine Funke. I am a cataract and glaucoma specialist out of the Arizona area, and I also do teaching for Creighton. And I'm here to talk about this LCD proposal and obviously my concerns along with my colleagues, mainly because glaucoma is a really challenging disease and we really want to do our best that we can to try and preserve and optimize quality of life for our patients.

So with that, next slide.

Financial disclosures here. Like many of my colleagues on these calls, we work with a lot of companies and that's because we really care about trying to be better with what we do in terms of glaucoma care. When I was a fellow, we only had very few options, and the amount of change that we've seen over the last decade has been a massive improvement in how we do with treating this chronic, progressive, and challenging disease.

Next slide, please.

So some things to talk about glaucoma is, one, you know, this is a disease that is lifelong. As we've all said, it is chronic, it's progressive, and it can be really devastating and as a clinician, we care about our patients' quality of life and quality of vision and that is our whole goal of what we do as ophthalmologists and glaucoma is a disease that can be really tough to see some of the negative impacts of. And we as a community want to do better to try and keep people's vision around as long as we can.

What's interesting about glaucoma is that we talk about pressure and pressure response, and that's one of the LCD discussions, is that talking about us successful if we see an IOP reduction of 20 to 30%. But what's interesting is when we check pressure, you can think about it like somebody who's getting their glucose checked who's a diabetic. If I check it once in a while, it's really not giving me a very good picture of what's happening. And that's because these pressures go up and down throughout day and night. And we are finding that that up and down is actually just as important as lowering it when we see them occasionally.

This disease also ravages certain subcategories of patients, such as African American patients and Hispanic who are higher risk generally, and I don't want that to be another limiting factor of people who already have challenges in getting treatment and care.

The other thing about glaucoma that is interesting is that a lot of our diagnostics are woefully under-helpful when it comes to understanding the location of the disease, where we need to treat. And so a lot of my colleagues have talked about trying to hit multiple mechanisms, and that's just it. We don't know where blockages are. We don't know where we need to go and try therapy. So doing multiple therapies at the same time, we're doing because we're trying to benefit patients and one surgical procedure as opposed to stacking multiple.

Next slide.

So again, just remember when we're talking about this disease, we're all so passionate about it because we see the devastation that can happen, including slow permanent vision loss.

Next slide.

One of the biggest issues with glaucoma that we see, and I think personally, as a clinician that I see daily is people just do not take their medication. We're asking somebody to take topical therapy for the rest of their life. It is a challenge. It's a challenge usually within six months, about half people will not be taking their medication. And within a year, the majority don't. We know this is an issue. It's an issue for most patients. And so we have to figure out a solution around that massive issue. And one of the biggest revelations for me and my practice has been using iDose because we know the medications work. We just know that the human component is the biggest issue. And so having that available has just been game changing for me and for my patients.

Interestingly, too, is that we have not only the issue around compliance to therapy, but we have a problem with compliance to follow up. And for a chronic progressive vision altering disease that the patient doesn't feel and doesn't initially see worsening of damage, we need them to follow up. And so we have found through research that patients who are managed topically have about a 70% chance of not returning to clinic within a year or more. That's really scary because we need to be seeing these patients much more often than that. And then we found that procedurally managed patients did better where they were seeing us more often, but still had a rate of 36% of patients still not coming back in to see me, which again is scary. But if we're doing something physically that's working inside the eye 24 hours a day and is going with the patient, they don't have to remember it. I at least feel better that when they're, you know, not following up, which happens very frequently, at least there's something always going.

Next slide.

How that impacts the amount of vision loss that we see. So patients who lapse for three plus years of follow up has been found through IOS registry data to have double the likeliness of going blind in an eye. That is also a scary statistic that we have to remember when we give topical medication because those patients are less likely to follow up with us.

Next slide.

On top of the issues around compliance, even if somebody is perfect with topical medication, we know that unfortunately, topical medication doesn't do a great job at looking at decreasing the amount of fluctuation in IOP, which is really important. So we know that bringing the pressure down 20 to 30% is usually a goal for a lot of our studies. But more importantly, we also know that we need to decrease the ups and downs of the eye pressure. Again, consider it kind of like with diabetes. We're trying to keep a very stable pressure, and that just doesn't happen with topical medication. So I fear if we are pushing people into a place where they have to do topical treatment first, we're already putting them in subpar care.

Next slide.

We've talked about, and I think Dr. Simpson did a great job discussing outflow pathways, but here's just a little picture to remind us how complex this disease pathway is, and treatment is just as complex. And so when we talk about outflow, there's two different outflow passageways. There's the conventional pathway, that's where we're talking mostly about MIGS, and then the unconventional pathway, which we're talking about prostaglandin analogs, like what's in an iDose. These pathways, we really don't know, again, where the resistance lies in a lot of patients, it's probably multifactorial in multiple areas. So it's nice to be able to work on multiple areas at the same time.

Next slide.

So considering all the things we have available, we consider these different modalities of treatment as symbiotic because each of them does something very separate from the other. So we're not trying to stack therapies that are doing the same things but actually doing different things with different mechanisms of action. And the reason for wanting to do them at the same time is because honestly, we don't like going into the eye multiple times in short bursts, because ultimately the eye is a small organ and it really can't handle as many procedures as maybe some other parts of the body does.

Next slide.

I think what's most important when we're talking about a new device is obviously data. This is my recently published retrospective analysis of my iDose plus MIGS with or without phaco patients. In this group, I had 107 patients that were looked at, both those who are getting phacoemulsification or cataract surgery and those who are not. These patients, a lot of them were on multiple medications to start. This is not uncommon to see in practice that people get to us and they're already on all these different medications and struggling usually with them. And these patients had true disease. So the visual field is kind of giving us an idea of how much loss we're already talking about.

Next slide.

The results of this was that, one, we saw a very large rate in medication free post these combined procedures. And why this was surprising in a good way is because these were probably my sicker patients that I'm doing multiple procedures on at the same time, and still their rate of becoming medication free was about 60% which is excellent, because then I'm not worried about the compliance issue. They are doing better that way. We also have seen throughout the LiGHT trial and the HORIZON trial that those who are getting something done physically to the eye tend to show less progression on visual field loss compared to those who had topical therapy.

Also within these subcategories, we looked at the amount of pressure drop. And with each type of procedure done in conjunction with iDose, we were seeing a nice decrease in the IOP as well as a decrease in medication burden.

Next slide.

This slide further breaks down the different categories of patients. And I always like to highlight, look at the patients who literally had just an iDose plus an iStent infinite by themselves. They went from 22.7 millimeters of mercury down to 13.1. That is so significant and such a big deal for patients. And so I can't emphasize enough how excited I was to realize that these combinations were working as well as they were for me and for my patients. And I don't want to lose that opportunity for them because I think as we continue to follow these patients, especially looking at their field progression or hopefully lack thereof, we're going to see better stabilization than we could have initially hoped for.

Next slide.

I just want to also walk you through a typical patient of mine, because I think it's important to understand that while we all on this call agree that SLT is a great option, it's not always the best option for patients and topical therapy works well, but again, more often doesn't work as well when the patient is involved and responsible for actually placing the medication itself. So this is a patient of mine who had, who came in to me, multiple medical drops had been used, but a poor compliance, known poor compliance. And yet the medications just kept getting prescribed over and over when I started to review the chart. The patient had a caretaker, but the caretaker was unable to give the medications because the patient was combative towards them. SLT was then performed multiple times to try and delay any surgical care. And all of that while you could see the visual fields just getting worse and worse and worse.

Taylor Canova:
One minute.

Dr. Christine Funke:
And in my opinion, thank you, if this patient had bypassed the topical therapy rounds and the SLT rounds and had just gone straight into the operating room, we would have had much better success. And we have those patients every day where we know that the best option is going in and hitting multiple mechanisms of action at the same time in the operating room. This patient got an iDose with MIGS and is now well controlled and independent of medication.

Next slide.

So my ask here is just to hopefully, based on all of the things that we're telling you, to really highly consider removing this proposed LCD because of its limitation to the care of patients with really challenging to treat blinding disease and instead decide that this just may not be the best course of action for patients and to give us as providers the option to understand what would be best for each individual that we treat.

If that's not possible, consider removing certain things, such as, because we know of the multitudes of studies of poor compliance, looking at not forcing patients to first go through drop therapy. I'm concerned that a lot of people won't follow up, because we know that that's an issue, and instead will just fall off of care and lose more vision. And then also the SLT is a similar issue, which is, it's an excellent option, but we want to make it just an option. It should be an "or" and not an "and." And finally, remember that we shouldn't define our success based on IOP alone, because truly, it can be a red herring for a lot of patients and we need to think more broadly than that.

With that, I just want to say thank you so much for listening to all of us and allowing us to speak. And I hope that this really helps to understand more about the challenges that we have in terms of taking care of glaucoma.

Dr. Eileen Moynihan:
Thank you for taking time from your trip to be with us today and give comment. I appreciate it.

Dr. Christine Funke:
My pleasure.

Dr. Eileen Moynihan:
Remember, many of you have sent citations. If they're not publicly available or we can't get them, we can't use them. So be sure to think about that. You may want to be sure that we have citations, and I think I have seen in the slide or full articles about some of these other points you're making all of that helps us to weigh everything as we're required to do. So again, whatever you can do to assist with that would be helpful. I know you've already given your time to speaking on the call, but just something to think about.

And if you don't make our deadline, if there are other contractors that are going beyond us with the comment period, you can always submit them there. But I do want to thank everybody again. And don't forget those brochures because my life is very boring according to what I'm gathering from this call.

So with that, I'd like to turn it back over to my team members for closing.

Taylor Canova:
Thank you. In closing, we would like to communicate the next steps in the policy development process.

The comment period for the proposed LCD will remain open until July 4th, 2026. All comments to be considered by our Medical Directors for the proposed LCD must be submitted in writing, as Dr. Moynihan said. Written comments can be mailed or emailed to policydraft@noridian.com or mailed to the address on your screen. Comment information for our proposed LCD is located on our website at noridianmedicare.com. Upon review of comments, our Medical Directors will either finalize or retire the proposed LCD. Response to comments will be viewable in the response to comments article. Please monitor our website or register for listserv notifications to be informed of actions taken on our proposed LCDs.

Dr. Moynihan, do you have anything else you'd like to say before we end the meeting?

Dr. Eileen Moynihan:
No, just thank you again for all your work.

Taylor Canova:
All right, thank you. Thank you. This concludes our meeting and have a great day.