Open Public Meeting: Multiple LCDs - October 30, 2025 - JF Part B

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 following LCDs: Temporary Nontherapeutic Ambulatory Cardiac Monitoring Devices and Peripheral Nerve Blocks and Procedures for Chronic Pain.

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 LCDs today. If closed captions are needed, please click the closed caption icon in the bottom right-hand corner of your screen.

For the presenters, you are being allotted four minutes to make comments. Your line will be opened when it is your turn to speak. Make sure you are not on mute within your system or we will not be able to hear your comments. You should be prepared to begin your presentation immediately when called upon and will hear the moderator's voice when one-minute remains. If you submitted a PowerPoint presentation, please tell the moderator when to advance to the next slide. Given the volume of speakers today, there may be a delay when transitioning to the next slide. Please be patient and proceed with your comments as normal. If you reach the end of your four-minute time limit, your line will be muted, and we will move to the next speaker to allow all registered commenters time for their presentation. 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. Luke Barre for the Temporary Nontherapeutic Ambulatory Cardiac Monitoring Devices LCD. Dr. Barre, you may begin.

Dr. Luke Barre:
Thank you, Kari.

Welcome everyone to this section of the Open Meeting which is focused on the Temporary Nontherapeutic Ambulatory Cardiac Monitoring Devices, or TNACMD for short, proposed LCD. My name is Dr. Luke Barre and I'm one of the Contractor Medical Directors here at Noridian.

We do have a full agenda today so as there are several registered speakers and I'll try to keep my opening remarks brief.

This policy addresses the use of temporary nontherapeutic ambulatory cardiac monitoring devices which include several devices including Holter monitors, vent recorders, patch recorders, external loop monitors, mobile cardiovascular telemetry and mobile cardiovascular outpatient telemetry for the detection and management of cardiac arrhythmias.

The covered indications and limitations are detailed in the proposed policy which is posted to the Medicare Coverage Database. I do want to highlight that TNACMDs are considered medically necessary and reasonable only for patients who meet the specific criteria which are set out in the policy. And that includes those who have symptoms suggestive of arrhythmias, those requiring medication management, or those with cryptogenic stroke, among others.

I do want to thank all of those who registered to speak on this proposed LCD and those who've already written with their comments. We do recognize that there's a lot of time and effort required to engage with proposed policies. Our process for writing policy is evidence-based and also relies on input from subject matter experts as well as feedback from all stakeholders. Your feedback is essential to craft the best possible policy.

I also want to reiterate a key point which is that all comments made today should be submitted in writing before the close of the period. All written comments will be recorded in the Response to Comment article. With that, if we can move to the next slide and we'll begin introducing our speakers for the TNACMD policy.

Okay. So I believe that I saw Dr. Mintu Turakhia here, even though I don't think she was on the mic checks, but Dr. Turakhia, your line should be open.

Dr. Mintu Turakhia:
Okay. I am here.

Dr. Luke Barre:
Please go ahead.

Dr. Mintu Turakhia:
Are you ready for me? Okay, all right, go ahead to the next slide. So keep going, we only have four minutes. So we're gonna be brief.

I'm only gonna focus on the first few slides and then highlight the others for evidence.

I'm the chief medical and scientific officer and a professor of medicine at Stanford as a cardiac electrophysiologist.

We applied the changes we believe this is necessary for modernization. The concerns we have are the following. There's uniform device requirements in the stated proposal. I don't think this was the intent, but the 24-hour monitoring stations for things like Holter don't even transmit during wear. What that cascades down to is some misaligned responsibilities between device and service. And the device requirements currently as written include criteria that should apply to the providers in IDTF.

Because of this, there's also some safety language contradictions which we believe need to be reconciled. For example, requiring devices to notify patients or emergency services is outside the intended use and labeling of most of these, actually all of these devices.

And there's inconsistent definitions that align to the new product codes.

Next slide. Can you advance to the next slide?

So again, not all -

Krista Babbitt:
It has.

Dr. Mintu Turakhia:
Okay, thanks. There's just a little bit of a delay.

So again, the proposal impact hits these four areas, but the misalignment is that this 24-hour service requirement, emergency notifications in real time do not apply to all of these.

And so there's an opportunity that we're happy to help with to clarify the language.

Next slide.

We're gonna go through all of these and just these are, you can just keep scrolling until I tell you to stop until the slide, until the second to last slide or the third to last slide. So just keep going ahead until you get to the journal of American Heart Association.

These are all slides that we want to show and will include in our response and provide you the documents or the papers that were not included that really explain the rationale behind the evidence, as well as modernization about the FDA. And so there's no time to go through all these. We will provide those.

You can go ahead and keep going.

We are committed to sort of low, high-value care at low cost. And one of the key determinants is that mobile cardiac telemetry could be unintentionally overused in the way that the current guidelines are stated. And because of that, there's actually data to show that it doesn't improve or expedite care.

So we want to partner with you, thanks, you can leave it on this slide, to really go for what's fit for purpose and avoid overuse of MCT and event recorders.

And I'll close out with the next slide.

So again, our recommendations are that we differentiate device requirements, clarify device versus service responsibilities, resolve the safety language contradictions, align with FDA classifications of the new product code of MCT in particular, and then use this as an opportunity and incorporate much of the clinical evidence that was not, was missed as part of the GRADE review and assessment.

If we do these, I think this will modernize, serve Medicare to be fit for purpose and enable high value care at low cost.

Thank you.

Dr. Luke Barre:
Thank you so much, Dr. Turakhia.

And thank you all for being patient because of, I believe it's the number of slides that we have, there is a brief lag as you've all seen between us advancing the slides and the actual display. So I appreciate your patience.

Dr. Turakhia, I appreciate your comments and looking forward to receiving the written ones as those will be very important to us.

We'll move on to our next speaker, which is Lindsay Silver, who's the Director of Reimbursement for Philips Cardionet. Your line should be open, and you may begin.

Lindsay Silver:
Thank you and thank you for the opportunity to present.

Next slide, please.

So, Philips is providing comment on six sections.

Next slide, please.

Some of which overlap with what was just shared. So, these are the six areas.

Next slide, please.

From a coverage criteria perspective, Philips is strongly recommending alignment of the coverage criteria based on FDA-approved indications aligned to cardiac monitoring as well as what's seen in the Novitas existing LCD that governs these services. We will provide the clinical evidence to substantiate the expansion recommendations.

Also noted here is the recommendation to incorporate additional notations, supporting providers ordering and utilizing the most appropriate type of ambulatory ECG based on product, or excuse me, patient needs, symptoms, and device label instructions.

Next slide, please.

In correspondence with expanding the coverage criteria, there is also a recommendation by Philips to expand the supporting ICD-10 codes that would substantiate the medical necessity. And these are exhibited in the Novitas existing LCD that governs services. Again, we will note and provide the clinical evidence to substantiate here.

One in particular is the stroke code I63.9, often used for cryptogenic stroke, which is denoted as a covered indication, but does not substantiate it in the medical necessity ICD-10 codes.

Next slide, please.

What was previously recognized was the device requirements section, again, aligning with what was previously shared, specifically around the 24-hour monitoring station requirements and the receiving station definitions that do not align to all ambulatory ECGs monitors.

Next slide, please.

Comment number four is specific to the section regarding limitations, two in particular, and this theme was carried on from the previous slide.

So noting here the 24-hour monitoring station, how that's defined and supported by both the NCD and Novitas' LCD, Philips recommends to eliminate confusion and pull that common language forward in the Noridian LCD.

And in limitation number twelve, providing additional clarity is recommended as this reads that potentially two cardiac event monitors may not be utilized within a 30-day period. Based on how Novitas has clarified language, we have provided a recommendation specifying the CPT codes that potentially apply to that.

Next slide, please.

Comment number five is specific to device types, which was noted previously as well. The intent here, recommendation here, is to remove some of the technology nomenclature and align it with CPT language and code descriptions.

And final slide.

Kari Dupreez:
One-minute remaining.

Lindsay Silver:
Is for, comment number six is specific to the documentation requirements. And in this area, providing additional clarity would be Philip's recommendation. And so we've provided the suggested recommendation on the right, basically providing clearer guidance on what is required and who's providing that level of documentation specifically regarding the signed, excuse me, signed documentation as because each, some of these services have multiple reports and so if the expectation is that that signature is carried over.

With that I will conclude the Philips comment section. We will be providing a formal letter and supporting evidence.

Thank you so much for your consideration and time.

Dr. Luke Barre:
Thank you so much for the comments and we're looking forward to receiving the written comments.

We'll move to our next speaker who is Dr. Jane Chen from Boston Scientific. Dr. Chen, your line should be open, and you may begin.

Dr. Jane Chen:
Thank you. Thank you for the opportunity to comment today.

Boston Scientific operates an independent diagnostic testing facility located in California, and therefore, this proposed policy will have a direct impact on patient access for these important services and technologies.

We urge Noridian to consider revisions to a few important topics, which, if not addressed, will prevent access to appropriate diagnostic testing for patients and create excessive administrative burden for clinicians.

We recommend the Novitas Ambulatory ECG Monitoring LCD as a good reference from which to consider alternative policy language for the following topics.

First, the coverage indications should be comprehensive and include medically reasonable and necessary diagnosis in the coverage language consistent with the billing and coding article list of ICD-10 diagnostic codes. We have identified 98 specific diagnostic codes which are supported by clinical literature but are omitted from the proposed Noridian policy.

In addition, the list of covered diagnostic codes should include appropriate unspecified ICD-10 codes to represent situations where additional clinical details are unknown at the time of ambulatory ECG prescription. For example, monitoring after cryptogenic stroke is medically indicated and is described in the proposed policy. However, the diagnostic code assigned for cryptogenic stroke, which is cerebral infarction unspecified, is not listed in the covered diagnostic code list.

Second, descriptions for device types as currently written in the proposed policy are inaccurate. For example, the mobile cardiac telemetry devices are described as real-time transmission, which is inconsistent with FDA clearance for any device included in the covered CPT codes. We recommend replacing the language in the device type section with the descriptions consistent with CPT code definitions and with the Novitas Ambulatory ECG Monitoring LCD.

Third, in the section entitled device requirements, there is a mandate that all monitors provide 24-hour monitoring capability. This is inaccurate because not all monitors require 24-hour surveillance.

The device requirements section also includes language mandating monitoring stations to be staffed by personnel such as critical care nurses and paramedics and to direct patients for management of life-threatening arrhythmias. The language is inaccurate since cardiac monitoring stations are not staffed by critical care nurses or paramedics, but rather by trained ECG technicians. Moreover, monitoring technicians notify the patient's physician, who then has the responsibility to direct the patient for management of emergencies.

We recommend referring to the Novitas Ambulatory ECG Monitoring LCD for a definition of a 24-hour monitoring station, which is more accurate and appropriate.

Lastly, the limitation as to the frequency of repeat monitoring is concerning. In clinical practice, the timing of and need for additional testing may vary by device type and patient diagnosis, even in the absence of new symptoms. We recommend removing the frequency limitations to allow for physician discretion in determining the type of device and frequency of monitoring.

We plan to send the formal -

Kari Dupreez:
One-minute remains.

Dr. Jane Chen:
- through the Noridian open comment process.

We also recommend revising the proposed policy language to better reflect description of the technology and removal of language restricting physicians' ability to prescribe monitoring.

Thank you for the opportunity to submit comments verbally and through the formal open submission process.

Dr. Luke Barre:
Thank you, Dr. Chen. And just a reminder, along with comments to please submit any relevant literature that you'd like us to consider if it wasn't included.

Moving to our next speaker, it is Dr. Kenny Civello from Louisiana Cardiology.

Your line should be open, and you may begin.

Kari Dupreez:
Dr. Barre, I think we might have lost him. I don't see him on any longer.

Dr. Luke Barre:
Okay, do we want to move to our next speaker and if he comes back, we can highlight him again or?

Kari Dupreez:
Yeah, let's go to our next speaker and we'll just keep an eye out for him to return hopefully.

Dr. Luke Barre:
Okay so our next speaker is Dr. Colleen Johnson from Tulane University School of Medicine. Dr. Johnson, your line should be open, and you may begin.

Kari Dupreez:
Well, I apologize, Dr. Barre, it does not look like Colleen is present either.

Dr. Luke Barre:
Oh, no. Okay. Do we have any other speakers for TNACMD?

Kari Dupreez:
We do not. So, I think, you know, at this point, we'll just have to conserve time and move forward on to the next.

Dr. Luke Barre:
Okay. Thank you.

Dr. Eileen Moynihan:
Good afternoon, everyone. I'm Eileen Moynihan, one of the Medical Directors for Noridian, and I'm listening on the Peripheral Nerve Blocks and Procedures for Chronic Pain, the proposed LCD.

Kari Dupreez:
Dr. Moynihan, I think you got muted.

Can you unmute yourself? Thank you.

Dr. Eileen Moynihan:
Yep. Sometimes the laptop just does that.

Where did you hear me? Right at the beginning?

Kari Dupreez:
Basically.

Dr. Eileen Moynihan:
Okay. So, I want to make a few comments about this proposed LCD.

First is that you have four minutes to speak and we'll alert you at the one-minute mark. Second is that please be sure that not only comments get sent in by written method, but also that if you have any new evidence, you please send that as well.

About the evidence. This LCD reviews the evidence for peripheral nerve blocks by condition and establishes limited coverage or non-coverage based on the evidence. The evidence was synthesized with GRADE approach and summarized in the overall conclusion section, as well as in the tables for each condition within the LCD.

This is a multi-MAC collaborative proposed LCD that includes CGS, NGS, Palmetto, Noridian, and WPS.

Overall, the review findings indicate the use of minimally invasive interventions, for example, nerve blocks, RFA, and cryoneurolysis, for the treatment of chronic non-cancer pain is currently not supported by the evidence. The LCD uses a threshold of at least moderate certainty evidence for coverage consideration.

The very low certainty ratings across comparisons indicate substantial uncertainty about the true effectiveness of these minimally invasive interventions. As a result, any observed effects may not translate into meaningful benefits for patients.

Peripheral nerve blocks, RFA, and cryoneurolysis, when compared to standard of care therapies, did not demonstrate consistent sustained improvements in pain, function, patient experience measures, and medication usages by the clinically important margin.

With that, I would like to move on to our distinguished speakers, and that is where the evidence will be important for any future potential changes.

I'd like to start with John Hsieh.

Dr. John Hsieh:
Yeah.

Dr. Eileen Moynihan:
Sorry if I mispronounce anybody's name. Please state your correct name.

Dr. John Hsieh:
Okay, my name is John Hsieh. I'm the treasurer for the California Society of Anesthesiologists, and I'm also in private practice in Newport Beach, California. So thank you for the opportunity for speaking. And I will submit all the study that's been published and through the comment format.

I'm gonna use this opportunity to talk about from patient's perspective and physician treating the pain patient. As most of you have known that pain patient can be the most difficult patient to treat, especially the chronic pain. And they have a very unique situation and require a physician that has a multiple different type of tool or medication to treat them and to get them into a functional status.

Therefore, by denying the nerve block as it's being told as being ineffective, it's a little bit outstretched of the reality.

It's when I treat my pain patient, nerve block can be a bridging solution and also avoid taking some of the narcotic pain medication which causes tremendous amount of side effects. And those nerve block is used potentially to bridging the gap while they having to do extra activities.

I have a patient, a Medicare patient, that need to go on a trip, go on a cruise, and by performing epidural injections or any other nerve block that potentially could help them during that period of time. And that help, it cannot be measured because that increases their functional status.

However, it's true that it doesn't take care of their pain problem permanently, but it help them to become more functional and realize the quality of life.

And at the same time by denying their benefit, it's going to have an untoward burden towards them, towards their financial well-being because the nerve block, if they've been done, it's going to get done anyway because they get tremendous amount of effect and they're going to have an out-of-pocket expense.

And that out-of-pocket expense gonna affect our beneficiary and I would think that the Noridian and all the other contractor for the Medicare will consider that the evidence base, it's nice to have it but at the same time is that also have to consider our beneficiary. What kind of situation they could cause and a lot of time this may not be totally measured based on the study out there, because most study having difficulty measuring the pain level. The pain level cannot be just measure the pain level, have to also look into the issue of quality of life and the lifestyle changes. And that's very important for our Medicare beneficiary.

And that's my two cents, and I will certainly put that in my comment in the formal written letter to both Noridian and through the online portal. Thank you very much for the opportunity.

Dr. Eileen Moynihan:
Thank you for your comments and for your upcoming written responses.

Next, I'd like to move on to Dr. Zachary McCormick.

Dr. Zachary McCormick:
Can you hear me?

Dr. Eileen Moynihan:
Yes, I can.

Dr. Zachary McCormick:
Thank you. Yeah. Good afternoon, everyone. I'm Zach McCormick. I'm a Professor and Vice Chair at the University of Utah School of Medicine, also ambulatory Chief Value Officer. I'm speaking today in my role as Vice President of IPSIS.

Next slide, please.

So I think that we're all quite aware that this is an incredibly broad sweeping policy change that frankly is going to have highly detrimental effects across numerous fields of medicine. They're listed here on this slide.

Next slide, please.

This policy is in direct conflict with guidelines from the CDC, these are from 2024, that recommend and promote a multimodal, multidisciplinary approach to pain management. And also reducing disparities, which the last speaker actually alluded to, that these policies would in fact end up resulting in.

Next slide, please.

This also is in direct conflict with the recommendations of the Department of Health and Human Services that were published over five years ago, and which specifically actually recommend neural blockade and radiofrequency ablation as non-opioid therapies to help with chronic pain management.

Next slide, please.

So we, IPSIS, has drafted a letter. This is an incredibly dense, twelve-page long letter that is currently circulating for sign-on. It'll be signed on by the entire MPW. As a reminder, that's the Multi-Society Pain Workgroup that was established in 2013 with the specific task of essentially helping the CMDs ensure the development of appropriate LCDs. The multi-society, excuse me, the MPW, is well aligned that these LCDs are not appropriate.

This letter is also going to be signed on by multiple other medical societies that are affected, physicians and patients who are affected, totaling over 100,000 physicians in the United States. This includes societies like AAOS, American Academy of Orthopedic Surgery, American Academy of Neurology, and many more.

So the specific ask is we are asking Noridian and the other MACs who propose this LCD to rescind it. And if the decision is to still move forward with an LCD of some sort, we're asking that you please sit down with us, the MPW, to discuss what would actually be appropriate criteria.

We do not believe that everyone under the sun should necessarily have these blocks or RFA procedures. But there are very critical situations where numerous patients do need these. And it would be a terrible situation to take this away from all of our Medicare beneficiaries and ultimately the entire American public, because we know that's what will happen based on what happened with sacroiliac joint interventions three years ago.

Next slide please.

Kari Dupreez:
One-minute remains.

Dr. Zachary McCormick:
Next slide please, thank you.

So, because I really don't have time to go into the specific details, I would say that what's most important that I can say is there is a critical evidence appraisal that will be forthcoming in this letter.

The methods that were used by the MAC and the subject matter experts that you alluded to were critically flawed. There are 10 systematic reviews, for example, on genicular nerve radiofrequency ablation. Nine of them are positive, one was negative, yet the LCD focuses on the one that was negative, which was actually inappropriate in its structure and design, did not appropriately stratify by procedure, by selection, by indication for the RFA, nor by lesion size and procedure type, which are really quite critical to a successful procedure when it comes to that one in particular.

I would also note that with the -

Kari Dupreez:
Thank you for your comments, but your time is up, and your line has been muted. We will have to move on to the next speaker.

Dr. Eileen Moynihan:
Thank you very much.

I would like to hear from Mark Malinowski.

Dr. Mark Malinowski:
Can I be heard?

Dr. Eileen Moynihan:
Yes.

Dr. Mark Malinowski:
Can I be heard? Okay, great. Thank you.

All right. Greetings, everyone.

I am Mark Malinowski, I'm chair of the Office of Reimbursement Policy and Advocacy Committee regarding the American Society of Pain and Neuroscience. I have no immediate conflicts of interest, and I do perform all 19 procedures as I am 100% clinical, and these procedures that I perform are considered apparently investigational as discussed in this policy.

Today I'm speaking on behalf of the American Society of Pain and Neuroscience. We have more than 3,000 members in our society, including but not limited to interventional pain management, anesthesiology, physiatry, interventional radiology, neurology, and neurosurgery among engineers and others.

At this time, we vehemently oppose the proposed LCD as the flavors of our dissent will be exhibited in this presentation.

We all know that CMS was founded on one unshakable principle, that every Medicare beneficiary deserves equal access to medically necessary care, no matter their zip code. If these policies are finalized, then these policies will divide the nation in a two-tiered Medicare system, One, where patients with chronic pain have access to evidence-based treatments, like in Florida, where First Coast allows these. But the other, such as patients in California, Noridian will not allow.

This kind of arbitrary, geography-based discrimination has no place in a federal program. It really undermines the very integrity of Medicare as replaces the fairness with the simple randomness and essentially punishes patients based solely on their address and zip code.

I would like to reference chapter 13 of the Medicare Integrity Manual requiring that LCDs define medically reasonable and effective care in addition to clarifying appropriateness, which is furnished in accordance with accepted standards of medical practice.

The MACs, including Noridian, the proposals do neither. They instead ignore both professional society guidelines and real-world outcomes that define modern interventional pain management. And worse, most of these policies, the proposed language was finalized while knowing that major meta-analyses, which was performed and published by Dr. Boreto and others, the new guidelines were recently done, but yet the LCD was ultimately rushed through.

So please skip to the last slide.

What is our ask? American Society of Pain and Neuroscience strongly urges the multi-jurisdictional MACs, especially Noridian, to immediately withdraw the proposed LCD.

We request that CMS possibly convene a Medicare Evidence Development and Coverage Advisory Committee, which is known as a MEDCAC, to review this science and develop a unified evidence-informed National Coverage Determination as opposed to the proposed LCD.

This is not a radical demand. It is a plea for standardization and for equity and for integrity of the coverage process and national policy would ensure that whether patients live in one area of the country or another that equal access is there.

CMS has a mandate to be both evidence-driven and patient-centered. It cannot claim the former while abandoning the latter by disregarding professional consensus and violating the statutory requirements and fostering geographical inequality among the MACs.

The path forward is clear. We request the LCDs reconsider the evidence-based – excuse me – reconsider the evidence transparently and work collaboratively with pain societies like ASPN who would be willing to be a part of an NCD development.

We would like to work with our stakeholders to develop standardized policies to continue to offer these safe and effective treatments for Medicare beneficiaries.

And finally, because pain does discriminate by state lines, neither should Medicare. We strongly urge that Noridian withdraw and rescind the current proposed LCD. And we have written letters accordingly, as well as supplied our entire presentation to the MAC.

Thank you, I yield my time.

Dr. Eileen Moynihan:
Thank you very much. I'd like to move on to Damoon Rejaei. Sorry if I mispronounce the name.

Dr. Damoon Rejaei:
No, that's fine. Can you hear me?

Dr. Eileen Moynihan:
Yes, I can.

Dr. Damoon Rejaei:
All right. My name is Damoon Rejaei. I'm an anesthesiologist and interventional pain doctor up here in Northern California. Thank you for the opportunity to speak here.

We get referrals in our practice from a variety of medical specialties, primary care physicians, neurologists refer to us for headaches, orthopedists and rheumatologists refer to us for a variety of musculoskeletal complaints, spine surgeons refer patients to us.

You know, before we do any interventions or nerve blocks, I can confidently say that 100% of our patients have exhausted a variety of conservative treatments before any interventions are done. And a large number of these patients, if not a majority, have had quite invasive surgeries done before, much more invasive than these nerve blocks that we're discussing here. Many of those patients respond to those surgeries, thankfully, but many of them don't. And so, people have, for example, knee replacement surgeries. Often, they have revisions of these surgeries. They have one, two, three, four spine surgeries. And unfortunately, these patients continue to have debilitating chronic pain.

And so then the question becomes, what do we do for them? What do we do for these patients who have had conservative treatments done in the form of physical therapy, a variety of medications with various costs associated with this? Some of these medications are very expensive, have side effects, have invasive surgeries done to them and they continue to have pain.

What do we do? So their primary care doctor can tell them to go home and just silently suffer, you know, that's an option. Of course, nobody wants to do that and nor should we. We can start them on different pain medications, at times more potent pain medications, opioids or otherwise. I think opioids, rightfully so, have gotten a lot of attention, but many other medications have side effects as well. We can increase the dose of those medications, and we've seen what that's done to our society in the last 30 years. And so what's left is they refer to our practices, our pain clinics, to see what we can offer these patients as part of a multidisciplinary approach to see what treatments can be offered.

And you know, I must say it's quite concerning and disheartening to see that these nerve blocks, these tools, are being taken away from our armamentarium and as part of the patient's toolbox to help address their pain.

We have a large number of patients who benefit from these minimally invasive, much less invasive than many other treatments out there, safe, cost-effective procedures. We don't have time to review each one of these nerve blocks nor is this the place for that.

But just a quick example, and I do not do a lot of these nerve blocks. I do a handful of these, but when it comes to, let's say for example, occipital nerve blocks for headaches, I get a few referrals every month from neurologists, headache specialists for these nerve blocks. These patients have tried medications, they continue to have headaches, and I probably have a panel of maybe 40 or 50 patients who two to three times a year, every three to six months, something like that, they come to our practice, and they really request these occipital nerve blocks.

All it involves is a 5-cc plastic syringe, a 27-gauge needle, and some lidocaine. That's all it requires. There's no cortisone. There's no, you know, other medications that have long-term side effects. That's pretty much the entire setup on our tray is what I just explained.

I can't think of a more cost-effective treatment really, you know, beyond over the counter Tylenol.

Kari Dupreez:
One-minute remains.

Dr. Damoon Rejaei:
And so these patients come to our practices two to three times a year. If it didn't help them, they wouldn't be coming back. You know, they're really exhausted. Many other treatments I've had patients endorse improvement in their sleep, improvement in their range of motion and just overall much satisfaction with these.

I hope we get some patients on the line today so they can express their personal journeys to you guys and to the review committee as well.

Thanks to you for the opportunity to share these concerns. I strongly ask that Noridian rescind this proposal and allow these tools to remain as part of our multidisciplinary approach to taking care of these patients who have really exhausted a variety of options and treatments before they come to our clinics.

Thank you for your time.

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

The next speaker is Dr. Gene Tekmyster. Please proceed.

Dr. Gene Tekmyster:
Hi. Thank you for having me. My name is Gene Tekmyster. I'm an Interventional Spine and Pain Physician at Keck Medicine of USC. I'm also here partially as my role as a voting member for the Advocacy and Policy Committee of the Pacific Spine and Pain Society, PSPS, which has generated quite a bit of volume of comments that we hope to address here for this proposed LCD.

Next please.

I'd like to start by really looking at how the LCD was established and some of my questions when reading it as to why the decision was made in the order to limit some of these where there is positive evidence for effectiveness of these procedures.

For example, occipital nerve blocks, which is recently mentioned by the previous speaker, it is noted in the LCD that this does provide effectiveness. There is evidence for temporary but immediate pain relief, which can be both therapeutic and diagnostic, with or without corticosteroids for reduction in headache and intensity. Multiple studies list the effectiveness and the benefit of occipital nerve blocks as quoted here directly from the proposed LCD publication.

Next please.

And we see the same for others but one other thing that I want to note is when you're defining nerve blocks and procedures we really want to be as specific as possible.

So what is a thoracic nerve block? It's a question that I had reading the proposal LCD and it's a question that I hope that the medical directors revisit when they're looking at potentially hopefully editing this to be in line with what medicine and anatomy actually dictates.

Now, a thoracic nerve block, are we talking about a thoracic epidural, a selective nerve root block? Are we talking a intercostal nerve block? Are we talking a erector spinae block? There are, I don't even know how many nerves in the thoracic spine, but which nerves are we really talking about? You can't list generalized evidence for nonspecific diagnoses because as we know, nonspecific diagnosis equates to nonspecific treatment.

So without really defining what a thoracic nerve block is and proposing evidence, it'd be hard for me to conclude that it's not effective even when, for example, selective nerve root blocks have a role for efficacy and so do intercostal nerve blocks for those with pleuritic and non-pleuritic chest pain after interventions.

So if we are gonna look at editing or as some past speakers have alluded to, which I do support, which is rescinding this LCD and maybe starting from scratch, because there's certainly a variety of evidence that has not been included into it, is really better definition of terms. So we have a better identification of a pathology and etiology and a particular algorithm of treatment for such diseases.

Next please.

Kari Dupreez:
One-minute remains.

Dr. Gene Tekmyster:
Daniel Imparse, for example, also have been shown for efficacy, and some of the listed studies here were not included in the evaluation. And as, again, other speakers have alluded to, there's a very selective group of publications that were included, but others that were not. And the ones that were included show low efficacy, whereas the ones that were not show greater efficacy.

Next, please.

Again, more showing that if you look at the very last line, you know, the author of a systemic review, which was not quoted by the LCD, found that there was more of an 85% success rate of treatment.

Next, please.

Kari Dupreez:
Thank you for your comments, but your time is up, and your line will be muted.

We will move on to the next speaker.

Dr. Eileen Moynihan:
Thank you very much.

The next speaker is Dr. J. David Prologo.

Dr. J. David Prologo:
Hi, is this okay? This is not me.

My name is David Prologo. I'm a Professor of Radiology and Vice Chair at Emory University and Emory Health Care in Atlanta.

That's me, thank you.

And I appreciate the opportunity to speak, and I also appreciate the comments of the previous speakers and will echo some of them. The primary point that I think should be made regarding this proposal is the context in which it has arisen.

Ten years ago, all of us on this line and across the country were charged with developing alternatives for opioid and medication therapy in order to address a worldwide and national crisis, an opioid crisis. And guidelines are provided by the societies and by the other speakers that outline this call for specifically ablations and blocks and the things that are listed in this very proposal, which, with all due respect, makes the proposal quite outrageous.

I would also like to echo what the previous speaker pointed out, that we are including an intervention that has bupivacaine in a plastic syringe with interventions that involve technology that imparts a very specific cold mediated injury to a nerve and subsequent Wallerian degeneration and regeneration and repair, two things at two very ends of the spectrum which make it look very much like the proposal was not only designed by selection of evidence but inclusion of procedures to fail from the outcome.

I want to also mention some sort of on the ground real life issues plain speak and that is that many of us including myself and my partners and many across the country are salaried academic positions. And so our motivation for commenting here and the society's motivations for submitting the comments are not necessarily for personal gain.

This isn't gonna take money out of our pockets. What this is gonna do is take 10 years of work of development, of alternatives for opioids, away from Medicare beneficiaries for what doesn't seem to be a well-defined targeting or a well-defined reason.

And in my remaining time, I'd like to share a few anecdotes because I'm not sure if patients are here, but we also see patients who are at the end of the line, desperate, have exhausted their other opportunities for care, conservative measures, and are oftentimes being admitted for refractory pain.

An example I can give, the great occipital nerve has come up here. Oftentimes that nerve is damaged during interventions and directed cryoneurolysis can induce not only interruption of signal transduction, but also degeneration and regeneration and repair.

Another example, iatrogenic damage of the femoral nerve, for example, in a desperate patient who spent 129 days in the hospital prior to having their image-guided cryoneurolysis performed, which interrupted their signal and stopped their return to the hospital.

And lastly, most importantly, those patients who have pudendal nerve damage related to either gynecologic intervention or traumatic vaginal birth or other who are great examples, probably the prime example of patients who don't have good options to manage their pains.

Kari Dupreez:
One-minute remains.

Dr. J. David Prologo:
These are young mothers often who are relegated to a lifetime of opioid therapy with all of its downstream side effects and horrible complications or a lifetime of pain without these innovative or standard therapies.

And my ask would be that we rescind the proposal in its entirety for the good of our beneficiaries and the care and relief that all of these physicians are offering these human beings. Thank you for the opportunity to speak.

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

I'd like to move on to Dr. Buvanendran. Sorry if I've messed that up.

Dr. Asokumar Buvanendran:
No, thank you very much.

Good afternoon, everyone. Can you hear me?

Dr. Eileen Moynihan:
Yes, I can. Thank you.

Dr. Asokumar Buvanendran:
Thank you.

Can you advance the slides, please?

And I'm a physician practicing in Illinois and speaking on behalf of the American Society of Regional Anesthesia, which has 5,000 members. I'm also speaking on behalf of the American Society of Anesthesiologists, which has 55,000 members.

Next slide. Next slide, please.

Obviously, chronic pain is a very increasing problem, and as previous speakers have mentioned, it affects about 50 million people, and the opioid crisis was an epidemic a few years ago.

Next slide.

As this has increased, we have done extremely well in controlling this epidemic and the number of deaths. The point of contention is that several nerve blocks which have been in practice for decades.

I personally have been in practice in chronic pain for 25 years and I should mention I do not have any conflicts. What I have done is, I have done research in chronic pain, and I am federally funded by NIH for the studying of chronic pain.

These are the various conditions with various indications, with various studies that are being funded across the country for the study of chronic pain.

Next slide.

I want to focus on two disease conditions.

Next slide, please. Next slide.

On stellate ganglion blocks for complex regional pain syndrome.

Complex regional pain syndrome does not have a single drug that is approved by the FDA for its treatment. As such, we use a combination of medications in addition to nerve blocks, such as the stellate ganglion blocks in addition to various neuromodulation techniques. This is pretty much the only possible treatment options for this debilitating disease with catastrophic consequences if not treated.

Several of the patients that I treat rather have the treatment of the injections or would commit suicide because of the extreme pain these patients have. So, it is very critical that we maintain these treatment modalities for this set of patients.

Next slide.

The other group of patients that I would like to touch base on is the utilization of genicular nerve blocks for radiofrequency of the nerve of the knee.

Next slide.

I personally was one of the early investigators who did cadaver studies on the genicular nerves of the knee to understand anatomy. Once we finished doing the genicular nerves anatomy, we would further went on to study randomized controlled trials demonstrating benefit of radiofrequency over other modalities of treatment.

Since then, there have been various clinical trials with various number of patients with multiple meta-analysis demonstrating efficacy of genicular nerve blocks radiofrequency for particular patients.

The reason why this is important is that if the genicular nerve blocks are not performed, the alternative is no different than opioids.

Next slide.

Kari Dupreez:
One-minute remains.

Dr. Asokumar Buvanendran:
You can keep proceeding through the slides.

The alternative to all these treatment modalities is opioids, and opioids have been shown to have significant mortality and morbidity. It's for this reason that we have done a very good job in covering back from the opioid epidemic and I urge Noridian to reconsider this LCD proposal.

Thank you for allowing me to speak. Thank you.

Dr. Eileen Moynihan:
Thank you for your comments.

Ashley Elsberry hasn't joined the call, or she has?

Kari Dupreez:
We do not see her on yet, so we'll have to try and come back to her later.

Dr. Eileen Moynihan:
Yes, okay.

Dr. Jennifer Hah?

Dr. Jennifer Hah:
Yes, hi, I'm here. Thank you for the opportunity. I think I'll dive right in. I'm a professor at Stanford University, pain management specialist, as well as representing the American Academy of Pain Medicine as secretary.

I definitely want to echo all of the commenters with my request to rescind the proposed LCD.

We want to maintain coverage for our patients. We do also feel that this will not create uniform pain care across the country but rather step care and prohibited access to some of the most basic procedures that we have fundamental to our pain practice.

One of the things that I want to emphasize today is that peripheral nerve blocks provide an extremely important foundation for the diagnosis of multiple pain conditions throughout the entire body without the ability to perform peripheral nerve blocks.

We don't have any other reliable indicator of where a pain generator is located in the body. At this point in time, there is no other diagnostic test biomarker, imaging study, X-ray, MRI, that is going to help us specifically localize the area of pain in a person's body.

And so this is very fundamental to our pain practice. We see that the proposed LCD states that for therapeutic peripheral nerve blocks, that they are not reasonable or necessary.

However, I would advocate that diagnostic peripheral nerve blocks must absolutely still be allowed without any limitations to the number performed in a given year. Again, because this is fundamental to diagnosis of pain conditions.

We see in many different studies, both perioperative and otherwise, that peripheral nerve blocks do provide the intended effect of anesthesia in the distribution of an affected nerve. There is no question that performing a peripheral nerve block will numb up the area that is intended where we think the pain is coming from.

The one important note, and the reason why there shouldn't be any limitation in terms of the number of these nerve blocks performed is that anatomy is not identical from person to person. There is extremely a lot of overlap in terms of peripheral innervation, and it often requires one or more or a combination of nerve blocks to adequately cover the area of a pain generator.

The other issue is that if we are to block patients from getting peripheral nerve blocks, this is also a fundamental to diagnosis of certain conditions.

Over the past one and a half decades, I've dedicated myself to treating women's health conditions. One of the blocks that's pointed out in the LCD is pudendal nerve blocks specifically. But the criteria for diagnosing pudendal neuralgia also rests on the principle of pain relief from a pudendal nerve block. This is part of the five essential criteria of diagnosis for pudendal neuralgia.

So here in and of itself, without the ability to perform peripheral nerve blocks for diagnostic purposes in these patients, we will not even be able to diagnose conditions and be able to provide patient specific care.

Kari Dupreez:
One-minute remains.

Dr. Jennifer Hah:
So it would be important to formally diagnose patients with certain chronic pain conditions.

So the one thing I want to leave with is I would like to emphasize that diagnostic peripheral nerve blocks should be allowed without limitation, that we should also retain access to important procedures like radiofrequency ablation.

Otherwise, patients will be forced to have higher levels of care. They will be forced towards more expensive operations, increased healthcare utilization.

The reality without peripheral nerve blocks is that patients will become more medication reliant. And this is the opposite of the goals of the last decade in pain medicine to increase access to non-opioid interventions, non-opioid medications. We really do need to maintain access.

Thank you very much.

Dr. Eileen Moynihan:
Hold on one second, Dr. Hah.

When you say unlimited diagnostic blocks, are you saying per block? So for instance, on the pudendal nerve, you would want unlimited diagnostic blocks of the pudendal nerve, or are you saying unlimited use of the code because they may be different blocks?

Dr. Jennifer Hah:
Unlimited use of the code because they may be different blocks. Thank you for the distinction.

And as I said, for pelvis, for example, there's a lot of overlapping innervation. So we typically have to do several blocks, ilioimmunol, genital femoral, pudendal, because it's going to be different from person to person in terms of where the pain is coming from. And it's very difficult for patients to be able to tell.

Dr. Eileen Moynihan:
Okay, thank you. I just wanted to clarify that point.

Dr. Jennifer Hah:
Thanks, thank you very much.

Dr. Eileen Moynihan:
Appreciate it. All right, let me move on.

Oh, I'm sorry.

Dr. Anna Woodbury:
You have me up and I'm unmuted, so I wasn't sure if it was time for me to go.

Dr. Eileen Moynihan:
Hold on, I've lost my place.

I think it's Dr. Woodbury next, yes, thank you.

Dr. Anna Woodbury:
Yep, that's me.

Hi, my name is Anna Woodbury. I'm an anesthesiologist and interventional pain physician from Georgia speaking on behalf of the American Society of Anesthesiologists regarding the draft LCD for peripheral nerve block procedures. There's strong evidence that supports the use of many peripheral nerve blocks including occipital cell, ganglion and genicular like you've already heard. Peripheral nerve blocks are essential for diagnostic purposes and have been used for many decades with a long track history of safety. Multiple systematic reviews and randomized controlled trials support the use of these blocks when appropriate clinical guidance is followed. For example, several of the reviews in the LCD documenting lack of efficacy for occipital nerve blocks evaluated only migraines rather than occipital neuralgia headaches, for which the occipital nerve blocks are not only diagnostic but part of the standard of care.

Headache types cannot all be lumped together, and neither can the pain syndromes. We need specificity, and it appears that those reviewing the evidence lack that background knowledge.

Further, there are at least two new systematic reviews published in 2025 that were not included in the evidence synthesis, one on genicular nerve radiofrequency ablation, and another on pudendal nerve blocks.

Despite the lack of published randomized controlled trials in some other cases, this does not represent a lack of efficacy. Functional and real-world data are more relevant for our pain patients, and as an example I'll give you two.

I had a patient who was raped more than a decade prior to seeing me, and due to the traumatic injury to her pudendal area, suffered from chronic pain and couldn't sit through a church service, which was a functional goal of hers. The pudendal nerve blocks offered her relief for about three months at a time so she could attend church, sit through the service, and help both her mental and physical well-being. These blocks also help patients participate in standard of care therapy, such as physical therapy, or in this patient's case, pelvic physical therapy, which they would not otherwise be able to tolerate.

Another patient of mine had multiple traumatic injuries to the foot, including a tank running him over, and was being treated for osteoarthritis of the foot with repeated steroid injections that would last only about a month. He had failed NSAIDs, Tylenol, physical therapy, he was taking Oxycodone, Dilaudid, and Gabapentin without relief. I suspected he had CRPS based on his clinical signs, performed a lumbar sympathetic plexus block that confirmed the diagnosis, leading to a successful spinal cord stimulator trial and permanent implant, after which he weaned off all opioids, returned to work, and no longer needed any injections. He would have continued to be treated inappropriately for osteoarthritis of the foot, if not for the diagnostic peripheral nerve block. This also resulted in overall cost savings to the healthcare system and decreased disability by him returning to work.

So, peripheral nerve blocks are opioid saving, as they provide patients with other non-opioid therapies. NSAIDs have significant side effects and a lack of efficacy for most pain syndromes. And ASA is supportive of patient access to appropriate use of peripheral nerve blocks and encourages strict clinical parameters for indications, repeat injections, and frequency.

The ASA will be submitting a formal comment letter that will provide more detailed information supporting the use of peripheral nerve block procedures and their importance. Thank you for your time and consideration.

Dr. Eileen Moynihan:
Thank you very much.

It's my understanding that the next three speakers are not on yet. That would be Dr. Shalini Shah, Dr. Forte, and Dr. Zachary Fisk. Did any of you join the call yet? If not, I will just move you to the end to see if you do join the call at some point.

Next speaker would be Dr. Hilton Kaplan from Avanos.

Dr. Hilton Kaplan:
Can you hear me?

Dr. Eileen Moynihan:
Yes, now I can, thank you.

Dr. Hilton Kaplan:
Thank you.

If we can go to the title slide, please.

I'm Hilton Kaplan. I'm the Chief Medical Officer at Avanos. And I'm speaking to you today on behalf of the Coalition for Interventional Pain Treatment, which represents seven industry partners who produce RFA and cryoneurolysis equipment. That's Abbott, Avanos, Boston Scientific, Medtronic, Pacira, Stratus, and Stryker.

And we ask that the proposed LCD be rescinded as new evidence has sort of made its conclusions invalid.

Next slide, please.

The LCD was drafted in February, but since then, Kanjanapanang and Madrid, with McCormick and others, reviewed 28 studies, including eleven RCTs and over 2,200 patients. And they found 61% and 54% responder rates at six and twelve months with moderate certainty evidence. So a clear and sustained benefit, but not the minimal effect that the LCD claims.

Next slide, please.

Eliminating coverage forces patients back to opioids or NSAIDs or forwards onto surgery, directly contradicting HHS, the No Pain Act, and other federal initiatives. Specifically older adults will need access to non-opioid, non-surgical options even more than the general public.

Next slide, please.

CMS data from 2024 shows that genicular RFA and cryo make up 6.6% of peripheral nerve procedures, a small fraction and not so-called overuse. The LCD also combines therapeutic and diagnostic blocks, even though diagnostic blocks are on steps towards ablation, and including them inflates the numbers artificially.

Next slide, please.

There are a lot of guidelines that already support RFA, including Aspen with level one, Grade A evidence, NICE in the UK, good evidence and no major safety concerns, and AAOS in the U.S. supports patient preference and driving use. And there are also two new guidelines that are imminent, the multi-society guideline, you see there, and the CRNA one. So this is mainstream evidence-based meds and not fringe care.

Next slide, please.

CGS relied on Almeda, which rated evidence very low and showed no lasting benefits, but it excluded 17 observational studies and lumped all RFA together. [inaudible] monopolar pulse, were all considered equivalent. It's like lumping a lot of surgeries together and judging them by the worst one.

And it also drew from older trials that predated large lesioning and multi-target techniques that have developed with new knee neuroanatomy.

So the paper in August that Kanjanapanang and Madrid published is a systematic review which shows clinically meaningful responses still at 12 to 24 months with moderate certainty. This reflects current real-world practice.

Kari Dupreez:
One-minute remains.

Dr. Hilton Kaplan:
Next slide, please.

The LCD applies a stricter evidentiary bar than other covered pain interventions like SI joint fusion or MR-guided focused ultrasound. And this risks inconsistent and unequal Medicare access, which was spoken about earlier.

Next slide, please.

So, in closing, we asked you to rescind the proposed LCD because, one, it contradicts federal non-opioid mandates. Two, it could create gaps in care for treatments that are reasonable and necessary. And three, it omits current high-quality evidence with new guidelines and studies eminent.

Thank you.

Dr. Eileen Moynihan:
Oh, thank you very much.

The next speaker, Dr. Samir Sheth.

Dr. Samir Sheth:
Hi, I'd like to take this opportunity to thank everyone who has spoken on this call as well.

I think a lot of the highlights of the literature, as well as a lot of the guidelines that have been stated, we can't overstate the importance of those. I'd like to, you know, I'm speaking on behalf of the Pacific Spine and Pain Society, as well as I'm on the Advocacy Committee for NANS and work closely with many of the people on this call.

I think the evidence is pretty clear and what we've seen with the proposed LCD evidence that was given was really kind of hand selected and hand-picked. I think what we've seen from our own evidence is contradicts what we've seen in the LCD.

More importantly, I think the, what we forget and what I think people have alluded to is the impact on our patients and I really would like to take a couple minutes to focus on that. Specifically, just calling out our Medicare beneficiaries who have worked their whole life to really get the care that they deserve, and including these disabled patients on Medicare as well.

I specifically can think of two patients I saw just this week, an 83-year-old gentleman with occipital neuralgia who comes in every three months for an occipital nerve block, but this allows him to not only function at a higher level, but this gentleman likes to ride dirt bikes still and he importantly has another function of being a social worker and volunteers at a hospice to take care of other patients who are Medicare patients perhaps.

My other patient is another 67-year-old female who is coming in again every three to four months for occipital nerve blocks and she comes in she gets these blocks in order to go and take care of her grandchildren back in New Hampshire. So she comes to me every three months to do this, to provide, for me to provide this service. I think what we are neglecting to see, while the studies are incredible and while we see some incredible evidence there, I think we're neglecting to see the impact that this will have on the quality of life for our patients in addition to increasing expenditure in healthcare.

I think this is a short-sighted, with all due respect, a short-sighted LCD, and I think it will have a huge impact on all the progress that we've made, especially with reduction of opioid use and really focusing on non-opioid measures for these patients.

I'm hopeful that with the with the support of everyone and the guidance that has been brought before us that Noridian and the other MACs will reconsider this proposal and rescind it completely, if not or allow for us to work together as Dr. McCormick said earlier to propose a new LCD that would be patient-centric.

I yield the rest of my time, thank you.

Dr. Eileen Moynihan:
Thank you very much.

I'd like to move on to Dr. Anthony Poggio.

Dr. Rodney Gabriel:
You mean Rodney Gabriel?

Dr. Eileen Moynihan:
Oh.

Dr. Rodney Gabriel:
Hello, is it okay, should I go?

Dr. Eileen Moynihan:
Yes, I'm sorry.

Dr. Rodney Gabriel:
Okay, you can advance the slide to the introduction.

My name is Rodney Gabriel. I am Associate Professor and Vice Chair in the Department of Anesthesiology at the University of California San Diego. I hold a lot of committee membership and leadership in major societies, including a founding board member of the International Society of Ultrasound Guided Cryoneurolysis, where I speak internationally and nationally for cryoneurolysis. I'm a funded researcher in opioid addiction and pain medicine from Foundation, Federal, and Industry, and I've been doing this procedure for about 10 years.

Next slide.

I'm talking specifically about cryoneurolysis, but this applies to other nerve blocks, specifically the Iovera system, which is a device indicated to use cryo to relieve pain and symptoms associated with knee osteoarthritis for up to 10 days.

The device on the right is FDA cleared for the specific indication for this. It's important to call out that iovera is currently recognized by Medicare as qualifying non-opioid pain management treatment under the No Pain Act, based on its proven ability to manage pain and reduce patient opioid use, and that's one reason why it's so important to maintain coverage and patient access for cryoneurolysis for chronic pain.

And so, we were requesting that Noridian withdraw the proposed LCD that would deny coverage for cryo and other pain management treatments and start fresh in collaboration with our clinical societies on a policy that recognizes treatments in their proper roles in management of chronic pain.

Next slide.

There is plenty of clinical support for cryoneurolysis as an opioid-sparing option for –

Next slide, please. Yeah, thank you.

For pain relief, given its mechanism, safety profile, published efficacy, and alignment with CMS, coverage for cryo is medically reasonable and necessary for appropriately selected patients.

Next slide.

The concern that we had is that evidence standard used to deny coverage for all of these pain treatments, it seems to be higher than the MACs applied to other treatments.

And so a key question for me is why are MACs holding treatments for pain to a higher standard than other treatments?

Next slide.

For example, here is a high-quality evidence evaluating cryoneurolysis for knee pain and symptoms associated with osteoarthritis.

This is from the Radnovich study design. It's a study of multiple institutions, 180 patients, randomized controlled trial. They looked at pain for knee osteoarthritis for cryo versus sham.

Next slide.

And you can see here that there were statistically and clinically significant reductions in pain and improvements in functions out to 90 days from this clinical trial.

Next slide.

And then in this year, recently October, there was a published systematic review and meta-analysis that confirms efficacy of genicular neurolysis, including cryo.

And the key takeaway here is that the systematic review and meta-analysis applies to the same grade methodology referenced in the LCD and concludes that there is moderate certainty evidence that genicular neurolysis provides clinically meaningful pain results.

So you're hearing a real concern from practitioners that even interventions that have high quality RCTs, systematic reviews, and meta-analyses as shown here as an example are seen as experimental or investigational for every potential use in chronic pain.

That just doesn't make sense.

Kari Dupreez:
One-minute remains.

Dr. Rodney Gabriel:
Noridian withdraws are non-coverage decisions.

This just summarizes that cryoneurolysis has been recognized in government reports and society guidelines, including AAOS, American Society of Anesthesiology, and the HHS itself.

This policy will reduce safe and effective alternative treatment options for patients and healthcare providers, and it conflicts with long-standing policy goals to reduce opioid use to treat chronic pain.

Next slide.

And so essentially what you've heard, we would like to echo the other presenters in urging that MACs to withdraw the current LCD and restart with a framework developed in collaboration with the clinical societies.

Thank you very much to you and to all the other speakers.

Dr. Eileen Moynihan:
Thank you, and I am sorry that I missed you. Thanks for being there.

All right, I'd like to move on to Dr. Poggio.

Dr. Anthony Poggio:
Hi, thank you for your time to present this.

Can you hear me okay?

Dr. Eileen Moynihan:
I'm getting an echo.

Do you have two devices on by any chance, maybe?

Dr. Anthony Poggio:
No, just the one.

Is this any better if I stand back?

Dr. Eileen Moynihan:
Speak some more and let's see how it goes.

Dr. Anthony Poggio:
Okay, is it better now?

Dr. Eileen Moynihan:
A little better, but we're still catching an echo. I'm not sure why that's happening.

Dr. Anthony Poggio:
How about now?

Dr. Eileen Moynihan:
We're getting it. I can understand what you're saying. We're just getting reverberations after you talk.

So try it. And if not, then maybe would it help, team, if he calls back in possibly? And we take the next speaker in the meantime. Kari, anybody?

Kari Dupreez:
Yeah, I think, Dr. Poggio, are you maybe able to try and go back in and, oh, speak again?

Dr. Anthony Poggio:
Is it any better now?

Dr. Eileen Moynihan:
Right now, it seems okay. Try again.

Dr. Anthony Poggio:
Okay, we'll try it this way. So I sort of lost the video too, So I'm just gonna skip the slides if it's okay.

Our concern is that the tarsal tunnel injections were not included in the allowance under the LCD and that neuromas, Morton's neuromas, are being limited to two injections per a lifetime.

The studies show that corticosteroid injections are safe and effective in the treatment of both of these conditions.

I've submitted some studies, which we'll submit again as part of our written report, that there is no documentation or evidence in the literature that for any restriction in the number of injections. Neuromas especially can be difficult to diagnose. There was the one example of the foot being run over. And if we try a couple of injections to try to diagnose the problem in the neuroma, we've pretty much used up our therapeutic aspect as well.

So we have nothing really to offer our patients if we've used our diagnostic tools up. So then we're only left with surgical options primarily, surgeries we try to clearly put off. A lot of patients can't have the surgery for medical reasons. With foot surgery more so than maybe other parts of the body. It requires significant non-weight-bearing and depending on if you have family, you're a caregiver of some sort, you may not be able to commit to that time, in which case we have no other options to offer the patient.

Many of the long-term complications which require pain management, nerve blocks, et cetera, are from the result of surgery where there's residual scar tissue or incomplete decompression. And these patients are in chronic pain. Most of the tarsal tunnel and neuromas we see are more acute, which we fortunately are able to treat rather well.

So the other part is with the restriction in numbers is how do we keep this straight? Patients move around, they see different doctors, they move jurisdictions and how do we know whether these services are covered or not and the patient may be left to foot a bill that they're not expecting, which is not fair to them beyond the fact that we are severely limited in our treatment options for those patients.

We will submit articles that show that injections are beneficial for both.

They avoid surgery. And in avoiding surgery, we also avoid possible complications. So our request is that the arbitrary two injections a lifetime for neuromas be removed as and allow tarsal tunnel injections as a legitimate treatment option.

Thank you for your time.

Dr. Eileen Moynihan:
Thank you. I am getting a message that the next speaker is not on. I'm sorry, Nathaniel Schuster, did you join?

Okay. Can I ask my team if anyone else has joined?

Dr. Nathaniel Schuster:
Hi, I'm here. I'm here.

Dr. Eileen Moynihan:
Oh, you are here. Okay, good.

Kari Dupreez:
Yep, he came back.

Dr. Nathaniel Schuster:
Excellent. Thank you. Thank you so much for having me.

So my name is Nat Schuster from American Academy of Pain Medicine, where I serve on the board of directors. I'm a practicing pain and headache neurologist, Professor and Medical Director at UC San Diego Center for Pain Management.

Next slide, please. Okay. Next slide, please. And next slide, please.

Okay, so at this point we've heard from so many wonderful speakers, International Pain and Spine Intervention Society, American Society of Pain and Neuroscience, many other societies, and we are all in agreement about the importance of rescinding this, having a pause, having a dialogue with the providers who treat patients.

And I want to share a couple of stories. One of them is my own story. I am both a clinician as well as I'm a father of children ages 5, 3, and 1. And my hands are full, and I have carpal tunnel syndrome, and I've treated myself with carpal tunnel steroid injections. I've done these injections on myself, and I know they work well, and I've not needed to have a surgery because of carpal tunnel injections. And I know that this is true as well for so many of my patients.

And what we saw with the SIJ denervation is that when CMS stopped covering that, providers started doing more of more expensive, more invasive treatments. And I have no doubt that with so many of these things that this is not, if it goes through will not be cost saving, it will lead to more invasive things.

For myself, I do not have the time to take away from my family, from my patients, to be having a surgery. And with some very quick injections, I have not needed to go on to a surgery.

A few days ago, changing to a patient, I have a patient of mine who had a horrible head and neck cancer. He's lost an eye. He's lost part of his palate. And once a month, just doing a local anesthetic block of his trigeminal nerve, that he has wonderful pain control. And this guy is going through something so horrible, worse than any of us could imagine. And that is all he needs is for me to do quick injections once a month for his pain control, no opioids, no medications. That is all he needs. And see this with so many patients.

Next slide, please.

So, this is what our job's all about.

I do placebo-controlled RCTs. I love doing placebo-controlled RCTs, but they don't give us everything. Part of this is individualized care for our patients. It's what we have to do every day.

Kari Dupreez:
One-minute remains.

Dr. Nathaniel Schuster:
And this is what we are advocating for.

Next slide, please.

So, so many have spoken about methodology, methodological problems, for example, this APM systematic review and meta-analysis, we concluded that, and I was one of the authors, that there is weak evidence in support because this was research done by academics for cheap injections, occipital nerve blocks.

We want academics to be doing and delivering some of these treatments because what's going to come in its place are going to be more expensive things.

In the case of headache, it's going to be more use of CGRPs. I have no doubt about that as a headache neurologist, let alone botulinum toxin, neuromodulation.

This is really for our patients going to drive up healthcare costs if we are unable to give them occipital nerve blocks, which we've heard so much about today.

Next slide, please.

So yes, utilization of so many expensive things. I care about the sustainability. AAPM cares about the sustainability of our healthcare system. This will have to happen.

Kari Dupreez:
Thank you for your comments, but your time is up, and your line has been muted.

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

Did any of the missing speakers for peripheral nerve block join the call?

Kari Dupreez:
We're not seeing any of the missing commenters for Peripheral Nerve Block.

We do have Colleen Johnson for our Temporary Nontherapeutic policy. She is present now.

Dr. Eileen Moynihan:
All right, I'll go back to her in a second.

I just want to tell those folks who are still on for Peripheral Nerve Block to be sure to send your comments in writing. And I would also ask you for the evidence that you submit, please be sure to submit the full articles because if they aren't publicly available, we may not be able to get them to review.

Thank you very much for all of your time.

And now let's move back to Dr. Johnson for our first topic, Remote Monitoring.

Dr. Colleen Johnson:
I hope you can hear me now. Sorry, I was on earlier, but on a different channel.

Thank you so much for giving me the opportunity to talk today on monitoring, especially cardiac monitoring as you're reviewing changes to its coding and other limitations.

One of the big things that I noticed, I'm although an academic physician and also a clinically active physician, and I read monitors every single day. One of the biggest concerns I had was on ICD code limitations. For monitors we have to understand that they're essential for screening to establish a diagnosis. And that screening is usually not done by the expert.

So, although cardiac electrophysiologists, which is what I am, end up evaluating and managing these arrhythmias, the people that actually screen for these arrhythmias are people like our OBGYNs or our general practitioners. And for many of those people, they are going to need those generic codes. They are going to need codes that are just for abnormal electrogram or cardiac arrhythmia unspecified because simply their specialties don't lie in these arrhythmias, but they are the route for our patients to get screened and for sometimes very dangerous arrhythmias to be diagnosed.

The other one that was mentioned by all three of the prior speakers was near and dear to most of our hearts, which is the diagnosis of atrial fibrillation, the setting of cryptogenic stroke. Although you have put it as a indication for these monitors by removing the ICD-10 code we use for cryptogenic stroke, you can see where the disconnect occurs there.

The other thing I wanted to comment quickly on, understanding the time limitations, is also the frequency of repeat monitoring. As a clinician, we use these monitors, and as a specialist, I should say, in arrhythmias, we use these monitors to help us not only diagnose arrhythmias but also to assess whether or not our treatment for arrhythmias is effective. And we need to use monitors for that.

Some people do not feel their arrhythmias and in arrhythmias, like atrial fibrillation, which can lead to stroke. We need to see whether or not our treatments are working in order to understand whether or not the patient is still at risk. Therefore, we may repeat the monitor in the same year using the same diagnosis code, which would be like atrial fibrillation.

So I really think that the ability to repeat a monitor should be at the discretion of treating physicians rather than outlined in a document.

Those are my feedback. I'm happy to provide those in writing. And I wanted to thank you again for coming back to me and apologize for not being heard at the beginning of this talk. Thanks again.

Dr. Luke Barre:
Thank you so much, Dr. Johnson. Appreciate your comments and absolutely looking forward to reading the written comments and appreciate Dr. Moynihan for allowing us to go back to our speaker.

And I believe that's it for the TNACMD speakers unless we had any of the other ones who have returned.

Dr. Eileen Moynihan:
Right, did any others for Peripheral Nerve Block come on in the interim?

Kari Dupreez:
No, I'm not seeing anybody else having joined since.

Dr. Eileen Moynihan:
Okay, thank you.

Kari Dupreez:
Yes, you're welcome.

All right, in closing, we would like to communicate the next steps in the policy development process. The comment period for the proposed LCDs will remain open until November 8th, 2025. All comments to be considered by our Medical Directors for the proposed LCDs 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 LCDs is located on our website at noiridianmedicare.com.

Upon review of the comments, our Medical Directors will either finalize or retire the proposed LCDs. Responses to comments will be viewable in the Response to Comments article. Please monitor our website or register for listserv notifications to be informed on actions taken on our proposed LCDs.

Medical Directors, do you have anything else you'd like to say before we end the meeting?

Dr. Luke Barre:
Nothing for me. Thank you, Kari.

Kari Dupreez:
Perfect, all right. All right, perfect.

So this does conclude our meeting. We want to thank you for attending the Noridian Open Public Meeting today.

Dr. Eileen Moynihan:
Thank you guys for all your work.