Kari Dupreez:
Good afternoon, everyone, and welcome to Noridian's Open Public Meeting. My name is Kari Dupreez, and I am one of the Medical Policy Specialists here at Noridian Healthcare Solutions.

We will be presenting the Botulinum Toxin Injections LCD today. 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 today. 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.

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 you will hear the moderator's voice when one-minute remains. If you submitted a PowerPoint presentation, please tell the moderator when to advance to the next slide. Please speak clearly to ensure that the system will be able to translate into captions for display. 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 article.

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

Dr. Eileen Moynihan:
Hi, welcome. I know your time is valuable, so thank you for choosing to spend some of it with us.

We're in the middle of a comment period, so there can be no questions asked by stakeholders nor answered by the contractor. This is a listening session by the contractor, although I may ask for some clarification on an item presented.

The current LCD was finalized almost a year after its initially proposed draft. A lot had to be clarified even since that draft was published. CMS asked contractors to have an open meeting on the clarifications. Contractors decided that instead of restricting comments to the clarified sections only, they would open the whole LCD for comments again.

This topic is the subject of CMS prior authorization projects. When that is the case, contractors will look to have the same LCD across the country.

LCDs prior to the current active LCD on the topic were different among contractors and often not produced by the methodology required by the 21st Century Cures Act. Therefore, an effort was made by the contractors to create a uniform LCD in line with the requirements of that 21st Century Cures Act.

Medicare generally pays for FDA-approved indications of a substance or drug when reasonable and necessary. Anything that is off-label must be supported in a generally accepted compendium or by moderate-level evidence in today's environment.

Contractors have to use publicly available evidence and decision making. When you are submitting articles that are not publicly accessible to support your position, you will need to submit full articles, or we may not be able to access them. In short, we are often looking for moderate level peer-reviewed evidence to support what is being done off label and how it is being done.

Finally, whether you speak today or not, all comments to be considered must be submitted in writing by the deadline of the comment period. If you miss our comment period deadline, you may submit to another contractor whose comment period is still open. We really only need to receive it at one contractor in order

for it to be considered by the group.

With that, I'm going to move into our first presenter. Abbey Linton, are you able to speak?

Abbey Linton:
Yes, I'm here. Can you hear me?

Dr. Eileen Moynihan:
Take it away.

Abbey Linton:
Okay, so our key concerns regarding the Medicare policies that are impacting patient care, one we have is disruption to, a disruption of effective long-term therapy. Patients who have been stable for years on botulinum toxin therapies are now experiencing denials, which are interrupting reverse previously well-controlled conditions, reducing quality of life. Things like barriers discouraging medically effective treatment, such as increasing complex prior authorization requirements and burdensome documentation standards discouraging providers to actually use Botox even when clinically appropriate, which means our providers are starting to have to push pursuing a CGRP instead of moving straight into Botox after two medications are tried and failed for at least two months.

The administrative burden is impacting patient care, meaning we're having to consistently bring patients back for follow-ups before we can submit so we make sure we're getting the appropriate information this time, which can take time for the patients to schedule. Some patients can come from further away, some may have, you know, mobility issues for us that they can't always come in or, you know, drop a dime and be able to be there when we need them, along with taking providers' time to do extra documentation for those patients to satisfy payer requirements.

Another one is the blepharospasm treatment limitations. The dose caps are below clinically effective levels, and we're experiencing denials despite long-term stability on already established dosing.

Symptoms are worsening, significantly impairs the function, including for our patients to be able to drive or independently function along with having safety concerns, which jumps into the sialorrhea moving from 12 weeks to 16 weeks.

That creates severe concern for our patients that have increased saliva production, which can actually increase the risk of aspiration, posing those serious health risks for those patients. So it's not ideal to move to 16 weeks.

Restrictions on injection techniques, such as no longer using follow the pain technique. These are specific muscles that need to be injected, limiting physician discretion, leading to suboptimal outcomes for patients.

The inefficiency in the denial process when we request information, we get an initial denial, say, for migraine. We then submit what the missing documentation was needed in the first place. We resubmit that, and then we get a denial letter requesting additional information that was not requested on the original denial letter. So that takes time out of our days to get that re-appended for the patient, along with delaying their patient care by having to reschedule them.

Dystonia, G24.8 and G24.9, were previously medically necessary and we're seeing those being denied on the back end as not medically necessary, even though we provide all of your, quote unquote, "robust clinical evidence" to support the toxin use. Undermines the evidence-based care and creates confusion for not only our physicians but our patients.

And lastly, the inappropriate diagnostic requirements for oromandibular dystonia (OMD). This is new on the LCD. You can no longer have OMD without the presentation of blepharospasms. That's a big thing for us. We have many patients that have one or the other. Some have both, but now we're not able to do OMD because it's not on the LCD and it's not approved for Botox use alone, even though the conditions can very much occur independently.

So I think that's it.

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

Amandeep Mann. Dr. Mann, would you proceed?

Dr. Amandeep Mann:
Thank you. Just confirming you can hear me.

Dr. Eileen Moynihan:
Yes, I can.

Dr. Amandeep Mann:
Perfect. I am Amandeep Mann and I'm representing Ipsen Biopharmaceuticals. We are the manufacturer and provider of DYSPORT or also known as abobotulinum neurotoxin.

Next slide, please.

My disclosures are that I am a full-time employee of Ipsen and hold shares of Ipsen stock.

Next slide.

This presentation is in response to MAC request for feedback on the updated MAC draft LCD policy consistent with the FDA approved uses of BoNT-A for Medicare population. Ipsen does not recommend the use of its products or any other products in any manner other than that described in the FDA approved prescribing information.

Ipsen Bio- [inaudible]

Dr. Eileen Moynihan:
We're not hearing you now. Dr. Mann, did you accidentally self-mute?

Dr. Amandeep Mann:
Hi there, can you hear me?

Dr. Eileen Moynihan:
Yes.

Dr. Amandeep Mann:
Sorry, my internet just disconnected from my laptop. I'm having some internet issues, so just do let me know if you cannot hear me, or I'll have to maybe push my presentation.

Dr. Eileen Moynihan:
I will.

Dr. Amandeep Mann:
Okay, perfect. Thank you.

So as I was saying, I will walk you through some key sections of the draft LCD policy that we feel need clarification and/or updates to ensure that the policy is reflective of the FDA approved labeling for DYSPORT or abobotulinum neurotoxin. We will follow up with a detailed response letter, including all relevant supporting references to be considered for the final LCD policy.

Next slide, please.

DYSPORT or abobotulinum neurotoxin, I may refer to this as Abo or AboBoNT-A throughout the presentation, is FDA approved for therapeutic indications including the treatment of cervical dystonia in adults and the treatment of spasticity in patients two years of age and older. Please refer to the approved DYSPORT prescribing information for complete details on the box warning for distance spread of toxin effect and other details.

Next slide, please.

AboBoNT-A has been available in Europe since 1990 and was first approved in the US in 2009 for cervical dystonia. AboBoNT-A has been marketed globally for over 40 years with over 5 million treatment years of patient experience and over 1300 peer-reviewed publications globally across multiple indications, including but not limited to cervical dystonia and spasticity.

Next slide, please.

Our first request is to correct the language for DYSPORT for initial dosing guidance for adult lower limb spasticity to align with the FDA approved label dosing. In the FDA approved label for DYSPORT or AboBoNT-A, the guidance is that dosing can be up to 1500 units for adult lower limb spasticity. And this is as per our registrational trial that showed that only 1500 units versus placebo showed a significant difference in MAS score in adult lower limb spasticity patients.

Next slide, please.

Our second request is to correct the language of AboBoNT-A dosing limits in the subsequent dosing guidelines to 1000 units for adult upper limb spasticity, 1500 units for lower limb spasticity, and the total body dose should not exceed 1500 units as per the FDA approved label. And this is consistent with our registrational trials that supported the FDA label indications in relation to upper limb and lower limb spasticity.

Next slide, please.

Our third request is to clarify the dosing limits described in the subsequent dosing guidelines and making sure that they are applied to the pediatric beneficiary. In addition, we would like to request the correction of the weight-based dosing to 16 units/kg as described in the FDA label for adult, I'm sorry, pediatric upper limb spasticity, and also noting that the max total body dose allowed for pediatric population is 30 units/kg or 1000 units.

Next slide, please.

Our last request is to clarify the use of EMG and ultrasound relative to the indication of cervical dystonia. When injecting AboBoNT-A, the FDA label actually suggests the use of guidance techniques, in addition to published literature that does show the support of using guidance techniques that can assist or may assist in mitigating adverse events by helping to visualize the target sites. In addition, we have a recent phase IV study in adult lower limb spasticity with abobotulinum neurotoxin showing that there is improved patient goal attainment in those that were injected with Abo using ultrasound when compared to those that were treated without

the use of guidance.

Next slide, please.

I want to thank you for the opportunity to be on the agenda and speak. As mentioned, you will receive a written detailed response from Ipsen with the feedback on the corrections requested for AboBoNT-A and the PI for you to review for the policy update. Thank you.

Dr. Eileen Moynihan:
Thank you and thank you for posting your conflicts of interest. Appreciate it.

Dr. Shprecher.

Dr. David Shprecher:
Hi, thank you for the opportunity to provide my public comments about the recent Noridian botulinum toxin updates.

I'm a director of a movement disorder program that serves the Phoenix metropolitan area. We are the only movement disorder program in the western Phoenix metro and serve a population of nearly 2 million people.

I'm very concerned that the current policies could put pressure on our institution to preclude us from the buy-and-bill model of buying botulinum toxin and then getting reimbursed from the Medicare plans after the fact. We're one of the only remaining programs in this western Phoenix metro area that still does follow buy-and-bill model, and most clinics will only allow patients to be treated if they order toxin through the specialty pharmacy under their insurance. However, Medicare patients don't have that luxury. And so most of the patients in the Phoenix metro area would lose access to care if we continue, if we, like some of our colleagues we've heard from earlier, start to see a large volume of denials of coverage and become unable to afford to treat these patients.

One important concern that I have, it wasn't clear in the current Noridian policies, that for patients who were treated prior to February 23 of this year where these objective scales were not part of our routine practice in our clinic or in many other movement disorder clinics in the country, it wasn't clear that their response to prior therapy based on their overall subjective improvement and impact on everyday activities, on pain, on social disfigurement of their movement disorder condition or spasticity, that that overall improvement compared to baseline will be sufficient to justify continued treatment. Some of these patients have been treated for five, 10, even 20 years with botulinum toxin, and we just don't have sufficient records or documentation to go back and try to generate an objective scale based on prior notes.

Appropriate approach to this would be for patients who have previously shown improvement compared to baseline with a subjective and objective measures documented previously by the clinician for that to be accepted as sufficient to document response and appropriate use.

I share the concern that was raised earlier that oromandibular dystonia should be considered an appropriate use of botulinum toxin, even if not comorbid with blepharospasm.

Another important challenge that we face is when treating blepharospasm or hemifacial spasm, many of these patients have a duration that is shorter than 10 weeks. Increase in the dose only results in ptosis and does not improve the duration of response of blepharospasm or hemifacial spasm to botulinum toxin. Therefore, on a case-by-case basis, it is standard of care and should continue to be standard of care to allow on a case-by-case basis for patients with blepharospasm or hemifacial spasm to be treated every 10 or even every eight weeks. So this is standard and covered by the European Agency, which is a corollary to Medicare here in the United States.

Among the requirements for failure of oral agents, I do have serious concerns that patients with sialorrhea need to fail oral agents before they can be treated with botulinum toxin. Almost all of our patients treated for sialorrhea and movement disorder clinics have severe constipation and are very prone to psychosis. Therefore, glycopyrrolate is contraindicated, and atropine drops, which are off label, are also contraindicated. I think it should be sufficient that Medicare patients be allowed to receive botulinum toxin first-line for sialorrhea, as long as we can document that these agents are considered contraindicated as they almost always are.

Similarly for spasticity patients, patients who have fist in palm spasticity, where they can't open the fingers to clean the palm, are at severe risk of skin breakdown, and this is a severe impact on safety and quality of life. This does not respond to oral muscle relaxants. Patients who have severe excessive ankle inversion or ankle plantar flexion when they attempt to ambulate, this also does not respond to oral muscle relaxants. It should be permissible for patients to forego oral muscle relaxants if, in the opinion of the treating clinician, muscle relaxants are not appropriate and not expected to be effective for the target symptoms.

Finally, I share the concern that was raised by Ipsen about dosing restrictions. Certainly, upper limb, we should be allowed to treat with at least 1000 units; lower limb, at least 1500; and we should be allowed to treat with those full doses if we're treating upper and lower limb.

Similarly, when it comes to DAXXIFY, daxibotulinumtoxinA, while the label does indicate 125 to 250 units is approved as a starting dose, we have clear clinical trial evidence, which I will submit in my further comments after this talk, showing that doses as high as 570 units can sometimes show continued further benefit with further titration beyond the initial couple of treatments for cervical dystonia.

This was seen in the phase two dose escalation study, which was part of the submission leading to FDA approval of daxibotulinumtoxinA, and an additional open label case series, which was recently published April 2025 in Neurology.

The dose of DAXXIFY should be left to the treating neurologist's discretion as with other type A botulinum toxins such as Botox or XEOMIN, a maximum of up to 600 units covered with appropriate documentation of having failed lower doses. And if the patient is being switched from a similar type A toxin, like Botox or XEOMIN, we should not be forced to undertreat the patient with 1/2 or even 1/3 of their original dose just to satisfy new Noridian criteria. We should be allowed to switch to a comparable dose if we're switching to a patient to DAXXIFY due to a short duration of efficacy.

So that concludes my public comments. And I want to just reiterate; I share all of the concerns that were raised by my colleagues from Evergreen earlier today. Thank you.

Dr. Eileen Moynihan:
Thank you very much.

Dr. Wong on, or do we need to move forward?

Kari Dupreez:
Dr. Wong is not on. However Dr. Meyers is. He is with her, and so he is able to speak on her behalf.

Dr. Eileen Moynihan:
So he will be doing this speaking.

Kari Dupreez:
Yes.

Dr. Eileen Moynihan:
Okay, Dr. Meyers, please proceed.

Kari Dupreez:
Are you self-muted, Dr. Meyers?

Dr. Benjamin Meyers:
Now, it just took a second to allow me to unmute myself.

Kari Dupreez:
Oh, there we go. Okay, sounds good. Thank you.

Dr. Benjamin Meyers:
Thanks for including us. If Dr. Wong joins us, I will hand off to her, but I will get us started on behalf of the Movement Disorders Division at USC in Los Angeles. Thank you.

We can go to the next slide.

Just as a summary, I think even some of our colleagues have introduced the types of patients we see in movement disorders, including patients who have blepharospasm, hemifacial spasm, and various types of dystonia that don't necessarily follow singular patterns. And so they may be a facial dystonia, cranial dystonia, oromandibular,

or a focal dystonia of other means. We also see patients for spasticity and sialorrhea in addition to our other patients who may not be getting botulinum toxin injections like Parkinson's disease patients, although a handful of those patients will also have dystonia due to their Parkinson's.

In the transition of these new requirements, similar to our colleagues, we have seen several patients weekly get denials for the same injections that have kept them stable on maintenance therapy for a chronic condition that gets worse if you don't maintain that consistency, and have had to bring some patients back for additional visits with delays of anywhere from weeks to months while their quality of life and their activities of daily living are impaired. The additional visits are also an extra cost to the patient and to the medical system, and the visits have needed to become longer so that fewer patients can be seen and more documentation time is spent. You know, I can say personally that it's much harder to look at and interact with my patient because I am having to keep the LCD up next to me and comb through it of what I'm going to need to document. And that additional documentation has made the actual care of following a patient from a previous note to the next much more hard to follow because there's insurance related documentation that is bloating away the medical takeaways that that we tried to use our documentation for.

We can go to the next slide. This may be small, so I apologize if somewhere on a smaller screen like a mobile device.

But I think overall what we're seeing is that when you don't see patients, it's very hard to make something hyper-specific and make it accurate. And so I think we feel that there are knowledge gaps in both the terminology and the conditions included and the doses that are non-medical. The patients we see and treat and help just don't fit this mold that feels to have been made. And so when things try to get so specific, there are infinite ways that mistakes can be made compared to when they are more general and broad. So some examples of that are, like our colleagues have said, the lack of other facial dystonias that don't follow those two singular patterns of blepharospasm or hemifacial spasm. Some have focal partial dystonias of the face, and the muscle is a muscle. I don't think we have such similar specificities for using a muscle relaxant for one muscle in the hand, but it not being approved for the extensors when it is approved for the flexors.

It has made following the documentation requests and requirements very challenging to know where they actually fit, and some of the conditions listed in addition to the face elsewhere in the body are not comprehensive. So the name for focal dystonia gives a writer's cramp, but it doesn't list any other focal dystonias that can occur for things like Parkinson's disease, where patients get foot cramping dystonia, or other types of musician's dystonias, or just idiopathic focal dystonias.

So, within those rules that we've been trying to follow, we have had numerous denials for patients who had their dates of service before the policies changed, and yet that visit was later not being paid for when billing was completed after the visit. So it has been challenging when it feels like the insurer is not following that own timing rule. And there have been other mistakes where we have gotten a reply of the denial based on certain dosing limits, and we have been following the limits that were cited. For example, you know, we were cited that we had a dosing limit on 10 units per site for a blepharospasm patient and our note clearly documented only using 8 units.

To be more specific of some of the gaps that have been hurting our patients, some muscles of the face that are not included in the LCD. Again, I don't think the point is to include specific muscles. I think it's to be more general, but for sake of example, the zygomaticus nasalis, levator labii, certain depressors are not listed. And we're having a lot of trouble with patients who functionally, medically require contralateral injections that are both humane, kind, and functional. So for patients who get high doses on one side, they may have double vision, dysphagia, biting of their lip, injuries, dental problems, as a result of the asymmetry, and we have not been able to find wiggle room on doing any sort of contralateral injection.

On the next slide, I think we can talk about some suggestions.

I think I've alluded to this, but that it would be helpful to have a more generalizable paradigm. So even having a different scale for essentially every different condition of dystonia has been very challenging. I think there are some scales that are more universal, for example, the global dystonia rating scale, the GDS. It does partition even parts of the face, the proximal and distal lower, proximal and distal limb, the trunk, the neck. So if we are required to use a scale, which also is not clinically based, even that scale is a research-based scale based on research time and not

clinical time parameters, having one scale would still streamline the process, both I think for the insurer checking the claim and for the patient and the doctors, nurse practitioners, and PAs performing these procedures. I think that would make things more in line with the patients we're seeing who don't fit in the very specific boxes based on their dose or specific muscles that are included. And even without scales, you know, every visit we document in an exam that can display the patient's dystonia. So I don't necessarily think a scale is even required, but if one needs to be, then I think a single generalizable scale would be helpful. If we need to have an actual disability scale as well, I also think choosing one scale that is more generalizable would be helpful. We do also mention that impaired quality of life, pain, or ADLs are affected in our history taking as well, even without a scale.

Our solution to potential timing problems would be for the transition period. So the first injection after the new requirements are made, I believe, should be a gimme. And at the very least, allowing for the transition period that notifies for the next visit what needs to be required. So that way, actually at the initial visit, you can make that change. Like many of our colleagues have said, we have seen patients three months ago, and so we don't have some of the documentation or quality scales that are requested, because that visit was three months ago. So it would make more sense to me to make that scale now at the first visit.

I think some of our questions relate to those exact problems, like why did the rules change? Was there a certain prompt? I can think of when there were some increased specifics of requirements when chronic migraine was improved, but I'm not aware of a specific condition that achieved additional approval now that prompted the change, and we're curious who the consultants and stakeholders were for the changes.

I think we are curious how to bill for our time now that the visits take longer and whether the modifier 22 can be applied now that work is, you know, more extensive than the previously usual services that had to be applied.

Kari Dupreez:
Dr. Meyers, one-minute remains.

Dr. Benjamin Meyers:
Thank you. And our last question would be just really how to code patients who have been getting Botox and have dystonia but don't fit into the box listed, like patients who have focal dystonia that is not writer's cramp or the other facial dystonias. Overall, I'm very happy with how communicative this process has been to join this meeting, and I look forward to that continued communication. Thanks, everyone.

Dr. Eileen Moynihan:
Thank you.

Dr. Stuart Seiff.

Kari Dupreez:
Dr. Seiff, can you hear us? Are you self-muted?

Dr. Eileen Moynihan:
We may put you back behind the other speakers, Dr. Seiff. If you have problems right now, come back on and we'll pick you up after the last scheduled speaker.

Could I move on? Oh, is he on?

Kari Dupreez:
I think we just moved him up, so let's see. Can you hear us now, Dr. Seiff, and speak?

Okay, I guess not. We will try and come back to him then and we can move on to the next one. Thank you.

Dr. Eileen Moynihan:
Amy Hornig, would you like to speak?

Amy Hornig:
Hello, hello, good afternoon, everyone. I am a medical outcomes and science liaison and pharmacist with AbbVie Medical Affairs, and I am here on behalf of AbbVie to comment on the proposed LCD for botulinum toxins, specifically for onabotulinum toxin A., which I will refer to as Botox today.

So on behalf of AbbVie and the patients we serve, we'd like to thank the committee for the diligent work that was done to develop this comprehensive Botox toxin injection policy, and also just for allowing us to comment on the reconsidered LCD. Additionally, everything that I say today will also be provided in the written comments that I will send after the meeting.

So you can go ahead and move forward to the next slide. And as a disclosure, I'm a full-time employee and shareholder with AbbVie.

Today, really, I want to focus specifically on areas within the reconsidered policy that impact patient access and clinical decision-making for Botox across three key indications, chronic migraine, cervical dystonia, and overactive bladder. So our goal is really to ensure the policy aligns with clinical evidence, guideline recommendations, and real-world practice while preserving appropriate provider flexibility as well as patient access.

So the first key area today, you can see on the screen, I want to discuss is chronic migraine with the goal of removing unnecessary step edits. So right now, the draft policy requires two separate two-month trials across multiple classes of oral medications prior to accessing onabotulinum toxin A. We are respectfully requesting the removal of this requirement as it's not supported by current clinical guidelines. So per the American Headache Society consensus and global recommendations, both CGRPs and Botox are appropriate first line preventative treatment options and are not strictly step-dependent. So this proposed requirement in the LCD actually introduces delays in care, particularly for patients who have contraindications to therapy, cannot tolerate oral options, or may have adverse events with agents listed in these classes, or may have already failed prior therapy. So additionally, it does not adequately account for combination therapy, which is increasingly used in clinical practice today when mono-therapy for chronic migraine is insufficient.

You can move to the next slide.

And so continuing in the chronic migraine indication, the next area we're requesting consideration of editing is to simplify and standardize outcome measures in chronic migraine. And so the policy currently requires tracking both a greater than or equal to 50% reduction in migraine headache days and a greater than or 50% reduction in migraine headache episodes. So we would recommend consolidating to a single clinically meaningful endpoint of greater than or equal to 50% reduction in monthly headache days, as this aligns with the clinical trial endpoints for Botox in the PREEMPT studies, as well as supports real world clinical practice. And tracking multiple redundant measures can create administrative burden without adding any clinical value.

And additionally, there is language in provision number three, which discusses reduction in functional disability, however, there are no scales offered to track this improvement over time. So we do support inclusion of measurement of functional outcomes but recommend flexibility in the tool selection rather than mandating specific thresholds. So this approach maintains rigor while also improving provider usability of the LCD.

So next slide, please.

And the second key area we're requesting modification of is in the indication of cervical dystonia. So we would request that the moderate to severe restriction from this policy be removed and allow providers use of clinical judgment in this area. So the draft policy requires classification of cervical dystonia as moderate to severe, and neither of the American Academy of Neurology guidelines nor our FDA labeling requires severity stratification of disease for the use of Botox. And cervical dystonia, as mentioned by several of the other providers, is a heterogeneous condition and patients with mild posturing may still experience significant pain and have a high degree of functional impairment. So these severity thresholds may disproportionately limit access to this treatment, especially for patients with limited specialist access and those in underserved populations.

And then the second request for cervical dystonia is to allow the use of additional objective assessments for flexibility and clinical practice. So we do support the use of objective assessments. However, tools like the TWSTRS Score are not designed for routine clinical use as they were developed and used specifically in clinical trials. And this is a cumbersome scale to use and integrate into clinical practice, and the scale also does not reliably distinguish the severity categories in cervical dystonia. So as a result, we are requesting to allow for diagnosis using provider clinical evaluation and differential diagnosis with allowing flexibility in the assessment tools used.

Next slide, please.

And then the third key area I want to address is for the indication of overactive bladder. So the current draft policy specifies using 100 units for initial dosing with 100 units for subsequent dosing. And we would request that the policy be revised to allow dosing up to 200 units, which is consistent with both clinical evidence and guidelines from the American Urology Association. And in the written comments you're going to receive after the presentation today, I'm going to be providing those guidelines from the AUA, which support dose escalation to 200 units in patients with inadequate response to 100 units, as well as I'll be providing information from the NIH-funded ROSETTA trial, which also demonstrates safety and efficacy at higher doses above 100 units. So restricting the dose to 100 units may result in suboptimal symptom control and limits the physician's ability to individualize treatment for the patient.

So I do want to reiterate that this is not about exceeding the labeled guidance. It's about ensuring the policy does not unintentionally function as a hard dosing limit, which could clinically impact patient care for this indication.

Next slide, please.

So in summary, I just, reiterating the three key considerations to this proposed LCD. First is to remove the step therapy requirements in chronic migraine that are not guideline aligned. Second would be to simplify outcome measures for both chronic migraine and cervical dystonia in order to both reduce burden while also maintaining clinical validity. And third is to preserve provider flexibility in both the cervical dystonia severity assessment as well as the dosing for the overactive bladder indication. So these refinements will help ensure that the Botulinum Toxins LCD reflects both current evidence and guidelines, as well as supports individualized patient care and avoids any unintended barriers to access for patients.

And as mentioned previously, I will be providing a written response of all of this information as well. So thank you for your time and consideration of these requests.

Dr. Eileen Moynihan:
Thank you.

Is Dorlyne Brchan on by any chance? We don't see you, but could you raise your hand, if you're on?

Are we getting any response?

Kari Dupreez:
No, we are not, so she must not be present, unfortunately.

Dr. Eileen Moynihan:
All right, then we're going to move on to Ginny Krumrie.

Ginny Krumrie:
Hi, I'm here from UCSD Health, representing several different departments. Can you guys hear me?

Dr. Eileen Moynihan:
Yes, we can.

Ginny Krumrie:
Okay, perfect.

So first I want to start with just the general section at the beginning, that general indications and limitations of coverage with regards to number five, which states that the botulinum toxin must not be given more frequently than every 12 weeks. We agree that most patients need a BTI roughly every three months. However, many patients are in cycles that are slightly shorter, like 10 or 11 weeks, which we have heard other presenters talk about that. And we recommend allowing us to provide robust clinical published evidence to support a different frequency that could be taken into consideration because that doesn't seem to be allowed in the policy when you want to deviate from that schedule.

Also in that general indication section with regards to number 18 in the same section where it says off label use of the serotypes for various indications and or dosing are intended to be evaluated and covered under the policy only in unique circumstances with robust published clinical evidence such as medical society guidelines. We recommend that we see full transparency on what robust published clinical evidence

will be accepted, how the submitted documentation will be reviewed and approved. We'd like to ensure that there's just consistency in what's approved for coverage across all patients, organizations, and what is denied. And we would appreciate if there are any specifics of what is, what you're looking for in those publications to gain approval that those guidelines would be made public.

Now I want to talk about some different conditions. When it comes to the condition of anal fissures, we have concerns that the initial dosage is low with the 20 units, and that's going to require a subsequent dose to achieve full results.

Currently, our colorectal specialists would like to recommend that the initial dose be increased to the same dosage as the subsequent dose of 60 units, because we're currently using this higher dose for initial treatments and our patients are not requiring a subsequent injection. So this would decrease the patient's need to come back in for additional treatment.

In regards to the hemifacial spasms and the facial dystonia, we have concerns that the policy does not allow for contralateral BTIs on the healthy side, although this is rigorously supported in a number of clinical situations. For example, a patient with flaccid facial paralysis from cancer or other brain tumors or injury or facial symmetry.

This was well presented by Dr. Meyers from the UC of Southern California, so thank you for that.

It also appears that the policy is using the term secondary hemifacial spasm to capture all sequelae of facial nerve injuries with synkinetic recovery. For example, like Bell's palsy, Ramsey Hunt, and this, and we're getting that language based on the resource that was provided by the policy from the paper by Yaltho in 2011 that was cited. So normally we would use other diagnosis codes, such as like the code for Bell's palsy, to represent these conditions that are specific for that condition, but those are not covered in the policy, even though they're referenced in this paper. It appears that based on this literature, these conditions would be approved, but we are being recommended to use the ICD-10 G51.8, which is the other disorders of facial nerves, which would capture that hemifacial spasm, but is not correct coding. So we'd like to just recommend that there would be a code increase for what is approved for those conditions.

When it comes to laryngeal dystonia, with regards to payment for only unilateral injections, the laryngeal dystonia section says bilateral TA and LCA injections for ADSD will not be considered reasonable and necessary when administered concurrently. However, we'd like to note that most patients require bilateral injections, and this should be taken into consideration. Also with the laryngeal dystonia, dosing for this condition varies quite a bit between the patients and it's based on clinical response. The policy currently sets standards around this dose, which seems odd because there's no actual FDA approval for dosing this condition.

Many of our patients are actually using less, are being prescribed less than the 1.5 units, which is the low end of the range of this policy. And we would like to not have denials just because we are giving less when there's no FDA approved dosing for this condition.

Then when it comes to abductor dystonia injections, ABSD, it's currently not covered in this policy, only the ADSD is. However, aside from medialization, BTI is the only other treatment option for ABSD. BTIs do have a variable outcome for this condition but are successful with some patients for ABSD, and we would like to advocate that BTIs for ADSD should also be covered.

We have some journal articles that I will submit with the written comments that can outline some of those things.

I'm going to move on to urology conditions. We agree with the presenter from AbbVie who just spoke that there should be an increase of allowable dosage for the overactive bladder to be up to 200 units when appropriate for subsequent injections.

Also, we would like to advocate for flexibility in objective outcome measurements. The proposed policy requires the use of standardized questionnaires such as OABSS, IPSS-S, USS, and PUF as a primary method of objective assessment. And while these tools can be valuable, reliance on questionnaires alone presents some practical limitations. Many validated questionnaires are not available in all languages, which limits equitability access for diverse patient populations. Also, patients with low health literacy, cognitive impairment, or physical limitations may struggle to complete these tools accurately. Questionnaires results may not fully reflect functional bladder capacity or the physiological abnormalities. In addition, some validated questionnaires are not included, such as the UDI 6 and the IIQ 7. We also recommend adding the PGIS, the Patient Global Impression of Severity, as a reasonable quantitative measure that's easy for patients to complete.

So we also recommend that we allow additional forms of objective assessment to meet coverage criteria, including bladder diaries that are demonstrating reduced functional bladder capacity, urinary frequency, and or incontinence episodes, and also to include urodynamic studies demonstrating detrusor overactivity, poor bladder compliance, and reduced bladder capacity. We also like to allow additional validated questionnaires, including the single question PGIS to be used as an objective measurement of severity. These measurements, or these measures, are widely used in clinical practice. They provide objective physiological data and are more accessible and reliable in certain patient populations.

When it comes to the IC and the BPS treatment pathway, the proposed requirement is that patients must fail extensive therapies, including bladder installations and hydrodistensions prior to a BTI, and that may unintentionally delay appropriate care.

The AUA guidelines for IC/BPS do not require stepwise therapy as an approach to treatment, but rather encourage shared decision making and individualized approach to therapies. In the guidelines, the BTI injections and the hydrodistension are considered in the same category of procedures for IC/BPS and to be not considered stepwise therapies.

IC/BPS is a heterogeneous and complex condition. The patients present with varying symptom profiles, including predominantly pain-driven symptoms or predominantly urgency and urgency urinary incontinence. Patients with urgency predominant IC/BPS may respond to therapy similar to OAB including a BTI and may benefit from earlier intervention. Additionally, hydrodistension requires anesthesia in an operating room and resources, introducing an increased procedural risk, higher costs, and delays in care. Our recommendations is to allow clinical discretion in sequencing therapies for IC and BPS, particularly for urgency predominant presentations, remove the requirement for a mandatory hydrodistension prior to the BTI, permit earlier use of BTI in appropriately selected patients who have failed conservative and pharmaceutical management.

Kari Dupreez:
One-minute remains.

Krumrie, Ginny:
Okay. When it comes to neurogenic bladder and dosing, the importance, the proposed limitation of dosing maximum 200 units for neurogenic bladder does not fully reflect the available or evidence in the real-world clinical practice. A common cited phase three randomized controlled trial comparing 200 units versus 300 units of Botox in patients with multiple sclerosis and spinal cord injuries, evaluated endpoint of reduction in urge urinary incontinence episodes, and the second endpoint of urodynamic detrusor overactivity and maximum system metric capacity. And so we, I've more to say about that, but we're just going to recommend that the limitation be, the dosage be, we allow the dosage to be increased from 200 units when appropriate.

Yep, I think I'm at time, so I'll just submit the rest as written, for written comments. Thank you.

Dr. Eileen Moynihan:
Thanks very much. Is Nathaniel Schuster on?

Kari Dupreez:
I am not seeing him on as of yet, but if you are, can you please raise your hand in case we're just not seeing you?

All right, I'm not seeing anything. I do see that Dr. Seiff is back on. We'll try to go back to him and see if we can hear him this time. Krista, he is slide 24. Perfect.

Dr. Seiff, are you able to hear us and speak?

It looks like you might be self-muted. We've unmuted it on our end, but we can't unmute on your end.

Okay, well, okay. Let's go back to Nathaniel Schuster. It does look like he is here. He's raised his hand. Can you move back to him, Krista? Thank you.

Dr. Nathaniel Schuster:
Yes, thank you so much for giving me the opportunity to present on behalf of APM. I am a headache and pain neurologist at UCSD, Treasurer for American Academy of Pain Medicine, which represents both pain physicians, pain psychologists, and other practitioners and patients who treat and suffer from chronic pain conditions, including chronic migraine.

So what we find in clinical practice, unfortunately, is many patients with chronic migraine receiving preemptive protocol, botulinum toxin injections, have gaps in their care. They end up being late in getting their next treatment because of the burdensome Noridian practices in botulinum toxin approvals. We see patients who are well controlled on botulinum toxin injections, and that when they're unable to get approved in time, that they do decompensate clinically, unfortunately, have recurrence of chronic migraine. They can be very well controlled. They can end up going to emergency rooms, needing, or just simply suffering, undertreated. There are so many obstacles facing our patients with chronic migraine who are Medicare patients, as they are typically ages greater than 65. There are patients on hemodialysis. There are medical concerns with them receiving tricyclic antidepressants and indeed most of them, you know, before there was botulinum toxin, that they indeed had tried tricyclic antidepressants and often without adequate benefit. Many of them are already on antihypertensives, including beta blockers, and they are at risk of cognitive side effects with topiramate and indeed patients on hemodialysis is readily clear, and it's not a good choice for them.

Furthermore, the CGRPs, unfortunately, are unaffordable for most of our patients who have chronic migraine who are Medicare recipients. As members of AAPM, we often treat these patients for multiple pain conditions in one visit, might be a 30, 20-minute visit. We might be treating them for their knees, for their back, for chronic migraine. We have a lot of conditions to cover for these patients. We have limited time, and the documentation barriers often make it impossible for us to address everything that these patients need us to address for them. So we might not be able to, you know, adequately discuss acute migraine treatments, for example, or adding additional preventive migraine treatments. We may not be able to really discuss adequately pain psychology, which we believe in and we advocate for, physical therapy, everything else that we want to be able to cover for these patients. And there's just not enough time when our focus is, and the patient's focus is, how can we document everything that is needed to get their botulinum toxin injections approved.

Furthermore, representing our pain psychologists, the behavioral health requirement, it limits access to those for some people with chronic migraine. And I published about this, that pain psychology can be the most effective thing for certain select patients, but there's not enough pain psychologists. There's not enough pain psychologists who understand chronic migraine treatment. There's just simply not enough pain psychologists to meet this behavioral health requirement, and it's going to, from a systems level, limit care to those who need it the most.

So suggestions, I think the practice of most American payers of approving botulinum toxin injections for one year, rather than requiring every treatment to have its own prior authorization, will prevent the gaps in care that are so horrible to these patients. I agree with prior speakers about allowing Q10 or Q11 a week injections that for some patients, this is what they need clinically. For some, you know, they might be traveling. A lot of my Medicare recipients that they are, you know, they travel at times and if they cannot get it within before they travel, that then they will clinically decompensate. I agree with the removal of step edits as previously mentioned. The 50% requirement is excessive; 30% reduction is clinically meaningful in the literature.

The requirement to document two-month trials, many of our patients who are ages greater than 65, they do not remember anymore. When they try these treatments, many of them have been on botulinum toxin injections for many, many years. They do not remember how many months their trials were of different oral pharmacotherapies.

And recommend removing the requirement for scales. When it comes to in the real world, you give these scales to patients, very often they do not complete them. If the physician needs to walk the patients through them, this is very time intensive. It takes away from being able to do other things, you know, providing comprehensive care for the patients. It can be hard to interpret these scales depending if the patient fills them out when they are late on their Botox, when they are on their Botox and they are doing well. And many patients they've been on botulinum toxin injections for years and they do not have baseline data. So I agree with the prior speaker who talks about having, for example, PGIC as a validated tool that often provides really the information needed for a condition such as chronic migraine that has symptoms such as, for example, increasing recognition of the cognitive effects of chronic migraine that can be captured in a PGIC in a way that cannot by some of these scales.

And I wanted to share a true story from one of my patients who I was speaking to yesterday. And he was late on his botulinum toxin injections, and in addition to chronic migraine, I'd also been injecting him at per instruction from his dentist. He'd broken multiple teeth because of his bruxism. This was a gentleman, a former football player, wrestler, very strong masseter muscles, had broken multiple teeth. He's late on his botulinum toxin injections. He breaks another tooth and he's showing me where this gap is in his mouth, where the tooth had been removed. He's shaking a pill bottle containing broken teeth in it, showing this to me, and he does not have the resources at this time to have this tooth replaced.

So these delays in the care have very tangible effects on our patients. And so I hope that these recommendations can be incorporated and can help prevent the sequela of the delays in patient care that we see.

Dr. Eileen Moynihan:
Thank you. Can we go back and see if anyone else came back on the line?

Kari Dupreez:
We do see Dr. Seiff on. We'll give that a try one more time.

Can you hear us and speak now?

Dr. Stuart Seiff:
Can you hear me now?

Kari Dupreez:
Yes, we can.

Dr. Stuart Seiff:
[inaudible]

Dr. Eileen Moynihan:
You're breaking up. Can you get a little closer to the mic, maybe, or?

Dr. Stuart Seiff:
How about, how about now? Can you hear me now?

Dr. Eileen Moynihan:
Yes. Stay, do-

Dr. Stuart Seiff:
Yeah.

Dr. Eileen Moynihan:
Yes, continue whatever you're doing, because it's currently working.

Dr. Stuart Seiff:
I represent the American Academy of Ophthalmology, the American Society of Ophthalmic Plastic and Reconstruction Surgery, and the North American Neuro Ophthalmologic Society. I have no disclosures.

Can we go to the next slide, if you can hear me? Thank you.

Dr. Eileen Moynihan:
Yep, we can still hear you.

Dr. Stuart Seiff:
Excellent, excellent. There is a God.

I just want to, first of all, I want to thank Noridian and all of you guys for basically being good partners and providing healthcare and cooperative services over the years to us physicians. And, you know, in the area of the botulinum toxin issue [inaudible]

Dr. Eileen Moynihan:
And now we don't hear you.

Dr. Stuart Seiff:
Actually, now you don't hear me? Can you hear me now?

Dr. Eileen Moynihan:
Okay, right now we do. Right now, we do. After you told me we were wonderful, then we lost you.

Dr. Stuart Seiff:
Alright, I will. Okay, well, you're wonderful, and we will continue from there.

I just wanted to point out that the Noridian current policies actually work fine. And I also want to remind everybody, and I know a lot of this concern about botulinum toxin use has been to try and prevent abuse in the cosmetic-sphere. But botulinum toxins were developed for functional use, and they only developed aesthetic uses secondarily. And we actually have a 40-year track record of the standard of care and clinical applications for the botulinum toxins. And I also want to point out that although CMS has encouraged payers, the MACs, to use the package inserts as guidelines as to dosing, I would point out that the package inserts for DYSPORT, XEOMIN, and Botox go back years and years, and there's a lot of clinical experience under the bridge here. And physicians were never limited to exact package insert treatment protocols. We always were able to use standard of care judgment in the best treatment of our patients. And this LCD, these LCDs, are really a regression in that regard. So I ask caution in working just off package insert when we have clinical experience.

So let me go through a few slides here.

First of all, we recommend revising number 16 in the general notes of the LCD. For a Medicare will allow payment for one injection per site, regardless of the number of injections made into the site. And it says a site is defined as an area. We'd like it to be changed to an applicable CPT code, which is for us basically 67412 most of the time, is reported once per eye or side of the face without regard to how many injections are performed. And the codes are reported once for a series of injections.

Next, please. Thank you.

And for blepharospasm, I would point out that I was actually, I'm old enough, I was one of the authors of one of the original papers defining under Alan Scott studies close to 40 years ago. The actual determining the dosing, and we looked at 1.25 to 2.5 units per injection site. And here in this initial dosing recommendation, 1.25 was wholly inadequate in every old study. So where this resurfaced as a basic tenant of guideline is kind of ignoring the literature that is out there, and for three injection sites, for onabotulinumtoxin A, Botox is clinically insufficient in these doses and number of injections. The typical treatment requires 5 to 9 per eye, totally around 25 units to effectively manage symptoms, and this is a 40-year experience. This total dose of 25 units is consistent with initial dosing guidelines for XEOMIN, which has a similar efficacy and safety profile as Botox. So we recommend the initial dosing regimen for Botox should be revised so that Botox and XEOMIN be allowed for as many injection sites as necessary up to 25 units per eye.

Next slide, please. There we go. Thank you.

So now let's talk about Meige syndrome and blepharoplasty and, excuse me, and blepharospasm. Within, there's a lot of inconsistencies in the LCD. And one of them, we're limiting the number of injections and dosage for blepharospasm. But within the LCD, you all state that more than 50% of blepharospasm patients progress to Meige syndrome, and Meige syndrome doesn't have these limitations. So you've imposed really artificial limitations on blepharospasm that are not consistent with the standard of care. And progression requires increasing doses as more facial muscles need to be injected for symptom relief. The LCD should be revised so that Botox is allowed up to 50 units per eye, aligning with XEOMIN. And then a blepharospasm with orofacial dystonia, no clinical rationale to exclude XEOMIN from coverage. It works fine. We have, you know, 30 years of experience with, 25 years of experience, with XEOMIN, and Botox and XEOMIN are really used interchangeably in the standard of care and in the practice for these conditions. And actually, XEOMIN has a lower cost to the insurance providers.

Next slide. There we go.

So flipping up, your hemifacial spasm. There's no clinical, this is actually important, was brought up by the other speakers. There is no justification for waiting one year, basically three or more treatment sessions, to increase the dose and or number of sites of injection for patient relief. Hemifacial spasm is a very difficult condition to treat. There's often underlying weakness and then hyperactivity, and each patient needs to be closely monitored and their dosing titrated closely. Increased dosing based on clinical response should be performed at the discretion of the physician at the next treatment session, based on inadequate response to the prior treatment dose, and basically this is you adapting the treatment to the individual patient, which is the standard of care.

For strabismus, initial dosing of Botox in one muscle is appropriate only for comitant, typical strabismus. Paralytic and large angle strabismus often require doses up to 10 units. Drug vial size and waste are unchanged, resulting at no cost difference because you're going to use a bottle per patient anyway.

Next slide, please. I think we're about done. Next side. Here we go.

Finally, the AAO, ASOPRS, and NANOS encourage policy revisions to support physician discretion and patient access to medically necessary care. We should reconsider restrictive dosing limits and escalation timelines, align the policy with real world of ophthalmic practice. That is to say, the standard of care that evolved over decades, reduce administrative barriers while preserving safe, effective care, and our organizations will follow up with detailed recommendations in our submission of written comments and supporting literature.

I thank you very much for your attention and for your indulgence in getting the speaker to work.

Dr. Eileen Moynihan:
Very much for hanging in.

Do we have Dorlyne Brchan by any chance at this point?

Kari Dupreez:
We do not.

Dr. Eileen Moynihan:
All right, my list says that we have had all the speakers that were present speak. Is that correct?

Kari Dupreez:
Yes, that is correct. So we can go ahead and at this point move into the closing and next steps.

Dr. Eileen Moynihan:
One thing I wanted to remind everyone, which I said in the beginning, but for those who missed it, we are asking for GRADE evidence, moderate, to support things that you feel should be covered in as much as you have evidence, please be sure you submit it with your comments and that you submit your comments in writing, and we're going to tell you when they have to be submitted by.

Okay, Kari, go ahead.

Kari Dupreez:
Perfect, 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 May 16, 2026. All comments to be considered by our medical directors for the proposed LCD must be submitted in writing.

Written comments can be 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 the comments, our medical directors will either finalize or retire the proposed LCD. Responses 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:
Only that I'd like to thank everyone for their time.

Kari Dupreez:
Perfect. Thank you. And this does conclude our meeting. Thank you for attending the Noridian Open Public Meeting today.