Cervical Fusion CAC Meeting - August 16, 2023 - JE Part B

Kari Dupreez:
Good morning, or afternoon, depending on where you may be joining from today. My name is Kari Dupreez, one of the Medical Policy Specialists for Noridian.

I would like to welcome you all to the Multi-Jurisdictional Contractor Advisory Committee or CAC meeting for Cervical Fusion. We would like to thank our CAC panel members, who have taken time out of their very busy day to join our meeting, to share their expertise on today's topic. We also welcome those attending in listen only mode and sharing interest on this discussion. As mentioned, this is a multi-jurisdictional CAC meeting, meaning a group of partnering MACs are working collaboratively to potentially develop an LCD. While Noridian CMDs lead these efforts, they are joined by a group of CMDs from partnering MACs.

The meeting will start with a few housekeeping items. I will then turn the meeting over to Dr. Eileen Moynihan and co-facilitator Dr. David Somners from Novitas who will be leading the CAC panel evidentiary discussions on behalf of all participating MACs.

All lines are muted except for the CAC panelists, the meeting facilitators, and the MAC CMDs.

The chat feature within the meeting is to be used for technical issues only and questions specific to topics discussed here will not receive a response.

The meeting is being recorded as required by CMS.

The recording and written transcript will be available after the call on the participating MAC websites.

For the panel members, we have tested your microphones, and all appear to be working correctly. When not speaking, we ask you to place yourself on mute to minimize background noise that may impact the quality of the recording and attendees to hear comments.

The timeframes we assigned were for ballpark allotments to gauge how the meeting is going.

If the evidence is not there, it is okay to make a short statement about the evidence and the rating of it, answer the question, if it can be answered, and end.

You do not have to take the time allotted if it is not needed.

We will conduct introductions shortly.

Please indicate for the meeting record any conflicts of interest.

Throughout the call, we ask that you announce yourself prior to speaking, so it is clear for the audience and the record who is providing each comment.

As part of this meeting, you are asked to respond to key questions on the confidence of evidence on today's topic.

To ensure we are able to discuss each topic today, we have set an estimated timeframe for each topic discussion.

When nearing the end of that time, the facilitator will interject to communicate we are low on time. We mean no disrespect to any expert speaking at that time.

This is only to ensure all topics get attention in the three hours today.

Lastly, for those CAC members that would like to provide comments to the discussion questions, please send them to your local MACs with a completed Conflict of Interest form. We will conclude with a brief summary on the next steps in our LCD development process.

I will now turn the meeting over to Dr. Eileen Moynihan.

Dr. Eileen Moynihan:
Thank you, Kari.

Could you advance the slides, please?

The purpose of the CAC meeting has changed.

Currently, the new rules became effective January 8th, 2019.

The CAC meetings are to discuss evidence and the literature on a topic.

Chapter 13 of the Program Integrity Manual advises that Medicare Administrative Contractors shall use available evidence of general acceptance by the medical community, such as published original research and peer reviewed medical journals, systematic reviews and meta analyzes, evidenced based consensus statements, and clinical guidelines to help form an opinion.

The meetings are not held to discuss already written or proposed draft local coverage determinations, as they were, done in the past. CAC members' role is advisory in nature, and comments, opinions on the evidence and literature are made to assist Contractor Medical Directors in determining if a proposed LCD should be developed and its potential content.

This function supplements the Medicare Administrative Contractors internal expertise and ensures an unbiased and contemporary consideration of the state of the art, technology, and science.

I'd like to take a moment to introduce the Contractors and the Medical Directors who are working on this.

As I mentioned, I am the facilitator along with Dr. David Somners from Novitas/First Coast.

And I'm from Noridian. Meredith Loveless and Neil Sandler are from CGS Administrators.

Dr. Mark Duerden is from National Government Services.

Dr. Judy Volkar and Jason Stroud are from Palmetto GBA and Dr. Robert Kettler from WPS.

The Subject Matter Experts or CAC members are listed in alphabetical order.

Would you please introduce yourselves by stating your name, your area of specialty, your location of work or practice, and any conflicts of interests starting with Dr. Kellogg?

Dr. Jordi Kellogg:
I'm Jordi Kellogg, I am a private practice Neurosurgeon in Portland, Oregon and I do predominantly just spine surgery, at least for the last half of my career and I have no conflicts of interest.

Dr. Eileen Moynihan:
Thank you. Dr. Kellogg.

Dr. Mende.

Dr. Mende:
Hello, I'm Kristin Mende. I am a licensed physical therapist and a Board Certified Orthopedic Clinical Specialist. I primarily now work in the academic setting in the Doctor of Physical Therapy program at Marist College and I have no conflicts of interests.

Dr. Eileen Moynihan:
Thank you. Dr. Ratliff, have you joined yet?

Ok, Dr. Ratliff, are you unmuted?

I'm gonna just move down to Dr. Rundell, Dr. Rundell?

Dr. Sean Rundell:
Hi, my name is Sean Rundell, I'm a physical therapist and an epidemiologist.

I'm an Associate Professor in Rehab Medicine at the University of Washington in Seattle. I have no conflicts of interest.

Dr. Eileen Moynihan:
Thank you.

Dr. Selph

Dr. Shelley Selph:
I am Shelley Selph.

I'm a family physician by training, but one of the core investigators with the Pacific Northwest Evidence-Based Practice Center located in Portland, Oregon and I have no conflicts of interests.

Dr. Eileen Moynihan:
Thank you. Dr. Shivers.

Dr. Joseph Shivers:
Hi, my name is Joe Shivers, I'm a Physical Medicine and Rehabilitation Physician associated with the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania and I have no conflicts of interests.

Dr. Eileen Moynihan:
Thank you, Dr. Slavin.

Dr. Konstantin Slavin:
Hi, this is Konstantine Slavin, I'm a practicing Neurosurgeon in University of Illinois at Chicago.

I have no relevant conflicts to today's discussion.

Dr. Eileen Moynihan:
Thank you. Dr. Traynelis.

Dr. Vincent Traynelis:
My name is Vincent Traynelis. I'm a practicing neurosurgeon focused on cervical spine surgery. I am at Rush University Medical Center in Chicago. I have no conflicts.

Dr. Eileen Moynihan:
Thank you and I'm circling back to Dr. Ratliff, that audio pin will get you every time.

Is he still unable to speak?

OK.

OK, well, Dr. Ratliff is a Professor of Neurosurgery and I'm gonna just say he's at Stanford University.

He has a lot of titles here.

He's Program Director of the Department of Quality and he does have a few conflicts of interest that we'll circle back to when he is answering a question because we're still having trouble getting him on audio.

So, I'm going to move on to a report from the Agency of Healthcare Research and Quality.

Dr. Shelley Self is principal investigator of the current evidence-based practice center report that you're about to hear about. Please hold all your questions until the end of her presentation. Dr. Selph has already incorporated some questions that I have given her from the medical directors into her talk and other questions can be asked at the end, but they should focus on the work done on this report. Anyone who's not speaking, please mute yourself.

Thank you. Dr. Selph.

Dr. Shelley Selph:
Yes.

So, next slide.

So, I'm Shelley Selph, and I've been doing systematic reviews on a variety of topics for over 13 years with the Pacific Northwest Evidence-Based Practice Center.

Next slide.

So, some guidelines Eileen just talked about, please hold your questions to the end and limit your questions to the material presented.

I want to point out to this is a high-level summary only because of time constraints and the individual study details and outcome details will be in the evidence report but are not included in this presentation.

Next slide.

Here's our review team.

We do include an individual who is a neurosurgeon, or spine surgeon, pain individuals, as well as physical therapy, statisticians, and epidemiologists.

Next slide.

None of us on our team have any conflicts of interest.

Next slide.

So, this report was based on research that we did at the EPC.

It was paid for by ARC, the Agency for Healthcare Research and Quality.

But the findings are, and conclusions are those of the authors, not, it may not represent necessarily the views of ARC.

Next slide.

So, the purpose of the, the review was looking primarily at treatments for cervical degenerative disease. This review was nominated by the Congress of Neurological Surgeons, and they published prior guidelines on the management of CDD in 2009, and it is the hope that our review will provide the evidence base for updated guidelines from CMS or others and the final report will be posted in the coming months.

Next slide.

So, we had 13 key questions and I'm not going to go over them all here or read them all here because I'm going to talk about them as we get to the results of these key questions. Next slide.

Next slide.

Next slide.

They're mostly here for reference. Next slide.

So, part of our methods we did look at multiple databases, mbase, Cochran, and Medline. We've looked at studies published since 2006.

That's because that was the search date end for the prior guidelines, and this is for operative studies only.

The prior guidelines did not address non operative approaches to CDD, so we went back to 1980 for those studies. We did do dual review of abstract and full text level and assessed each included study for risk of bias or their study quality.

We also assessed for each key question the body of evidence for that key question by using the domains that are listed there.

And just a comment about what strength of evidence for us means, and essentially the strength of evidence reflects our confidence in the truth of the findings.

So low strength evidence applies that we have low confidence that future research will not change the findings.

Strength of evidence could also be rated moderate high, or in some cases, insufficient.

We use insufficient when we have too little, we have some evidence, but too little evidence to really draw any conclusions, or the evidence is too conflicting to draw a conclusion.

Next slide. So, we reviewed almost 4,500 abstracts and of those, we pulled about 1,500 full texts to review. We wound up including 106 studies.

The key question with the most evidence was for key question eight, which looked at the comparison of arthroplasty versus ACDF.

And for that key question, we had 33 studies. And then again, the draft and then the final report coming up will be, will have all the specifics. Next slide.

So, the first key question looked at individuals where you have, you do an MRI and you have this incidental finding of spinal cord compression, but the patient essentially has no myelopathy.

Should the patient go to surgery or should there be other ways to manage the patient, either no surgery or some other conservative treatment, like exercise or collar, or physical therapy.

Unfortunately, though, no studies addressed this question in that population.

Next slide.

So as key question two is very similar only in this, in this case, you do have individuals who have either mild, anywhere from mild to severe myelopathy. Again, should, should they go to surgery or should they have some other treatment. We did find a little bit of evidence on collar or medication in bed rest but not enough to be able to say whether surgery or no surgery would be preferred.

Next slide.

The next question is looking at all comer's radiculopathy and myelopathy patients.

What's the evidence in surgery, the benefits, and harms of surgery versus no surgery.

We did find a little bit of evidence for physiotherapy and a collar but not enough to make, to draw a conclusion from.

Next slide.

So, the next slide is looking at surgery versus the same surgery, plus an add-on treatment.

For instance, collar, electromagnetic stimulation, or exercise. We didn't care if the, if the treatment was pre-op or post-op.

However, all we were able to find were studies that looked at post-op treatment.

The first comparison of ACDF versus ACDF plus a collar, a little bit of evidence but not enough to say anything.

ACDF versus ACDF plus electromagnetic simulation. We did find a small effect that favors the use of adding on electromagnetic stimulation when the outcome is fusion.

So, slightly more likely to be fused if you use electromagnetic stimulation.

But again, not a, not a great body of evidence.

So, so, our strength, our strength of the evidence is low, meaning we have low confidence that future research will not affect that conclusion.

With regards to pain and function, with the use of electromagnetic stimulation in addition to ACDF, we had similar findings regardless of whether or not you use the electromagnetic stimulation or not, again, but low confidence in those findings.

Looking at laminoplasty versus laminoplasty plus a collar, similar findings on pain and function.

But again, low confidence for those findings.

For laminoplasty versus laminoplasty plus exercise, we felt we had insufficient evidence to, to draw conclusions and in that comparison.

Next slide.

So, the next one is looking at anterior versus posterior surgery at 1 to 2 levels.

In this case, anterior surgery for this group of studies was anterior cervical foraminotomy, anterior cervical decompression without fusion and ACDF, and in all comparisons, the posterior surgery was posterior cervical foraminotomy.

Basically, the results on arm pain, reoperation rate, neck pain, neurologic deficits they were similar, but low strength.

Evidence are low.

Confidence in those findings.

I do want to point out there is a concern for selection bias and making this anterior versus posterior comparison, because often different people receive, could you go back, please?

So often different people receive the two different types of surgery.

For instance, a posterior surgery may be more likely to be found in older individuals with higher comorbidities. In order to help mitigate the selection bias there, we did focus on RCTs. However, most of the evidence was not good quality.

And we looked at nonrandomized studies, but we required that the study control for at least one potential confounder, for instance, something like age or comorbidities going in.

That meant that we did not include a fair amount of studies because they did not control for anything.

And in some cases, concluded that, for instance, anterior surgery is better because the outcomes are better.

But, you know, they were really operating on two different populations. So those studies are not included.

Next slide.

So, for Key Question 6, it's the same question only we're looking at greater than or equal to three level disease.

We have low confidence that there are similar results with regards to neck pain function reoperation rates, mortality, and dysphagia.

There was a moderate to large effect favoring anterior surgery with regards to serious adverse events, so you had fewer serious adverse events with anterior surgery.

Same with neurologic adverse events, and our confidence is still low.

And the same concern for selection bias is Key Question 5, and we handled it the same way.

Next slide.

Key Question 7 is looking at patients with myelopathy, what are the benefits and harms of laminoplasty versus laminectomy and fusion.

A little bit stronger evidence here.

With the, we have moderate confidence that function and reoperation rates are similar with the two procedures in that population.

There was moderate to large effect favoring laminoplasty with regards to adverse events, but our confidence in that finding is low.

Next slide.

So Key Question 8 is the key question that we had the most evidence in. It was looking at the comparison of cervical arthroplasty versus ACDF.

We had moderate confidence, moderate strength evidence that pain and function are similar with regards to those two procedures. It was a moderate to large effect favoring arthroplasty as in fewer reoperation rates with arthroplasty at one level, strength of the evidence is high there, and but at two levels it drops to low.

There is a concern here that, in ACDF reoperation rates at the index level may be affected by the need to remove a plate in adjacent segment disease.

Unfortunately, a lot of the studies that reported reoperation rates did not report the indication for the reoperation rates and when we were able to, we parsed that out but oftentimes, we were not able to.

So that is a concern with this body of evidence.

With regards to serious adverse events, it was a small effect that favored arthroplasty.

But we have low confidence in that though, similar with, similar effects with, on neurologic adverse events.

Also wanted to point out that many of these studies were funded by industry, and they were written by authors with ties to industry, which may have introduced some bias also.

Next slide.

So Key Question 9 has several parts. The first part had the most evidence and that's looking at a standalone cage and for ACDF versus a plate and cage.

Essentially, we found the results to be quite similar between the two approaches. In fusion, we were moderately confident that the fusion rates are similar with neck pain function, quality of life and adjacent level ossification. We weren't quite as confident that those are similar.

Next slide.

Still Key Question 9: we looked at again also in ACDF we looked at PEEK cages versus titanium or titanium coated cages.

Essentially found a small benefit favoring the PEEK cage on fusion and function, but there wasn't really a lot of evidence there.

So, we, we have low confidence that that would stand up in the face of additional research. Key question, or next slide rather.

And then we looked at in ACDF the use of autograph or allograft or other osteogenic materials.

Unfortunately, there was pretty much only one study that looked at each of these comparisons. So not a lot of evidence for any given comparison.

Of the findings that we were able to say is that there was a large increase in adverse events if you use BMP-2. So, it favored the nonuse of BMP-2 but due to the quality of the studies of that evidence or strength of the evidence, we rate it as low.

Next slide.

So, for Key Question 10 in the, in the case of pseudoarthrosis. Pseudoarthrosis after anterior fusion surgery, should you use a posterior approach versus revision anterior arthrodesis. What are the benefits and harms for each of those approaches? Unfortunately, no studies addressed that.

Next slide.

Key Question 11- "In the instance of myelopathy, what's the prognostic utility of an MRI for neurologic recovery?"

There was a moderate benefit if there was no signal, less sharp signal, or decreased signal intensity that you could predict neurologic recovery but the strength of the evidence for that was low, given the, the number and quality of the studies.

The other issue with this body of evidence is that the question was in myelopathy unfortunately the studies included radiculopathy only patients or, in some cases, did not specify patient's symptoms.

So, not, not the best evidence based for that question, and we, we rated it low.

Next slide.

Key Question 12 can you use imaging to predict pseudarthrosis. Pseudoarthrosis, basically found. Yes, somewhat with dynamic radiography.

Either in asymptomatic or a symptomatic population, but low confidence, and that, that would hold up with additional research.

Next slide.

The next slide looks at intraoperative neuromonitoring versus no intraoperative neuromonitoring.

With regards to the neurologic complications, they had similar findings, but we rated that low, low strength of evidence or low confidence that that would hold up with additional studies.

One of the issues with this literature is that it's based on two database studies, where neuromonitoring or no neuromonitoring is determined by billing codes, and not all the time is neuromonitoring is used.

Is it billed for…

So, we think that the utilization would have been the preferred method of determining who got neuromonitoring and who did not.

And because billing codes were used, that may, may actually significantly undercount intraoperative neuromonitoring and that could potentially bias those results. Additionally, the studies were limited to ACDF and no other surgical approaches, so we rated that low strength.

Next slide.

So, overall, the highlights for the strengths and limitations are that we used the best evidence approach relying on RCTs.

When possible, and looking at, only looking at nonrandomized studies it controlled for at least one potential confounder for efficacy.

For limitations, there was often low-quality evidence, too little evidence, or no evidence for some of the key questions, and we did limit studies to the English language.

Next slide.

So, our conclusions were that there were a few differences in benefits between compared surgical approaches and techniques. There were some differences and frequency of adverse events. However, we are limited by what is reported in the studies, and there is concern for bias in much of this evidence.

Next slide.

So, this is just a link for your reference about where to go when the final report comes out.

Next slide.

So, some of the questions that you had, were any studies focused on the typical Medicare beneficiary age 65 and older?

So, when you look at each of the key questions, the mean age of the participants by studies, the mean age was in the forties, fifties, or sixties.

When you're looking at key questions as a whole, for no key question, was the average study mean age greater than or equal to 65.

And that's looking at the body of evidence.

But now, if you look down at individual studies, we found 11 studies with the mean age greater than 60, four with a mean age greater than 65, and two studies with a mean age greater than 70.

Additionally, there were numerous other studies that included individuals with ages greater than or equal to 65.

Unfortunately, for these studies that had a broad range of ages enrolled, they did not report the results by participant age.

So, I think the Medicare beneficiaries you know, that that population are in, you know are in the body of evidence, but not always parsed out as to the specific results for those individuals except perhaps in those studies that, that pretty much only enrolled older folks.

Next slide.

So, were there any studies that focused on diversity and not generally? In fact, very few studies reported race or ethnicity even.

Some studies did report, the percentage of their population enrolled who smoked, used alcohol, or had diabetes, but typically, you know, they did not report the results by these patient characteristics.

So, diversity focus was not found in the literature.

Next slide.

And did the Medicare age group tolerate general anesthesia and was mental status permanently affected? So, these were not reported.

I did go back and look at specifically in those, those studies that enrolled an older population and none of them reported issues with general anesthesia or mental, mental status changes.

Sometimes all we have for those studies are a statement saying there were no serious adverse events or there were no complications noted, or they may have listed some complications but never met it, never mentioned anesthesia or mental status changes.

Next slide.

So, I open it up to your comments or questions.

Dr. Eileen Moynihan:
Are there any questions from the Contractor Medical Directors, or from the panelists, for Dr. Selph?

OK.

Thank you very much. We are going to move on to the discussion questions that we have.

I just want to point out, on our final agenda, that question six has been moved to the end to allow more time for discussion, and that there have been some bibliography changes to the original bibliography that you were sent. At this time, try to remember to say your name before you give a response. And I am going to turn this over to my co-facilitator, Dr. Somners.

Dr. Somners:
Thank you, Dr. Moynihan, I assume everyone can hear me.

We're now going to go through the questions that were developed for the cervical fusion Subject Matter Experts. Certainly, appreciate everyone that's here today.

Again, we, we ask that, you base your opinion on the clinical literature, and certainly, with the consideration of the quality of evidence to support your answer.

Question Number 1, "What is the evidence and/or society guidelines concerning the provision of nonsurgical (conservative) care prior to proceeding with cervical spinal fusion surgery?" And there are two subparts that I will interject as well, Dr. Rundell and Dr. Mende. We would ask you to comment on these. We have about 10 minutes to do that and as I said, we'll talk about A and B, or if you want to raise those yourself, you certainly can. Please go ahead. Thank you.

Dr. Sean Rundell:
Sure, I can start.

This is Sean Rundell, so generally in the broad topic, I think there's a, there's a lot of uncertainty, non-surgical care for, you know, conditions before, sort of conditions before proceeding with spine fusion surgery specifically cervical radiculopathy and cervical myelopathy.

Starting with cervical myelopathy, there's really a lot of uncertainty, I think there's minimal to one clinical trial out there.

So, the evidence, really, is low quality or, or inconclusive.

The other literature out there besides that trial that I could see, is, are basically observational studies comparing non-surgical interventions to surgical interventions or fusion for people with myelopathy.

There's a lot of variability and who's selected as far as severity myelopathy too.

So, I think, regarding non-surgical care, for people with myelopathies it's fairly inconclusive.

Moving on to think about cervical radiculopathy.

There's a little bit more evidence and a lot of the evidence I'd say, is low strength of evidence or low certainty.

So, there's some evidence that sort of multimodal. We have approaches involving specific exercises, education, and maybe some cognitive behavioral components for people with more chronic cervical radiculopathy may provide some benefits for people, but that same body evidence doesn't really suggest that, that multimodal intervention provides greater benefit then surgery or fusion for, for people in cervical radiculopathy and does not provide greater benefits as a Neuro surgeon injections.

But again, that's based on very few trials and probably low strength of evidence.

When you look at the physical therapy clinical practice guidelines and there's some and again it's probably low quality of evidence or low strength of evidence that you know interventions, such as strengthening and stretching exercises, and manual therapies.

[inaudible]provide benefit to people with cervical radiculopathy or they [inaudible] cervical neck pain with radiating symptoms into the arm.

You think about it just neck pain in general. Maybe not specific to cervical radiculopathy or myelopathy.

The evidence comes a little bit better, and they have a server review guidelines, which I think is included in the reference section.

And there's moderate strength evidence for general neck pain, interventions such as exercise, and manual therapy combined with exercise, provide benefit for people, then there's a little bit weaker evidence.

So, probably lower, very low strength of evidence that things like reassurance, education, recommendations to remain active, use of various types of analgesics, some psychological interventions, and multi-disciplinary care may provide benefit for people as well.

Generally, my take on the whole non-surgical interventions for people with these conditions is that lot of literature is not only limited by the lack of quantity and then even quality, but there's just of what's there, there's a lot of variability, and the study samples for radiculopathy, for example, a lot of times the literature is a mix of people with, mix of ages, but also mix of people with radiculopathy due to disc herniations, combined with people with radiculopathy due to cell shifts from degenerative changes and similar with myelopathy there's often a mix of severity or how they grade severity, determine severity is really very variable. So, there's lots of uncertainty there.

A lot of the interventions, non-surgical interventions tend to be multimodal so it's really hard to tease out what specific non-surgical interventions provide benefit over other surgical and non-surgical interventions.

Because so often they're comparing multimodal interventions to some comparator and there's really not a lot of standardization and comparators, outcomes used, follow-up at times they are looking at, in general.

I can just parse A and B briefly, too, you know, part A, you know, there's really not a lot of strong evidence.

It's just that the minimum timeframe is recommended or number the minimum number of visits, so I'd say that's pretty inconclusive.

And also, when you go through their prognosis for Part B, percentage of patients that resolve without surgery.

I think for cervical radiculopathy there's a little bit more evidence suggesting that a lot of people have a fairly favorable prognosis.

Some reviews just yet, somewhere between 75 and 90%, see improvements, in symptoms, especially over the first six weeks.

But even with that, a sizable portions of people still have persistent symptoms or have recurrent symptoms.

The studies I looked at, that generally ranges from 20 low 20% to low 30%.

People have persistent or recurring symptoms after cervical radiculopathy, and then cervical myelopathy that prognosis, especially without surgery, is much less clear, literature is very old, and low quality.

The general consensus is that [inaudible], may be a progressive condition, but maybe a slowly progressing condition. But to be able to put a percentage on it, I think it's, you can't conclusively say that. So.

This is my summary thank you.

Dr. David Somners:
Dr. Mende, do you have some comments?

Dr. Kristen Mende:
Yes, this is Kristen Mende. I think Dr. Rundell actually summarized it pretty nicely. For the most part it really is, there's no strong evidence, necessarily. It seems to be, there's a relatively low level of evidence out there concerning conservative care, more specifically looking at like physical therapy and some of the other conservative options, and one of the limitations in the studies that are out there, as was just mentioned, is that variability in the interventions, they range from just putting someone into a cervical collar, to doing several hours of traction a day. So, it's very hard to really get conclusive evidence when the interventions that are being assessed and kind of all pulled together are so variable.

So, kind of looking into both parts A and B, similar to what was just said, there's really so much variability with respect to, what you might see in the evidence to support a specific timeframe.

And even in looking at some of the systematic reviews that were on the reference lists, some of them don't even indicate the length of time for the studies that were examined for the patients to have received the conservative therapy. Some range from a few weeks up to three months. So, it's just quite variable.

And then the percentage of patient's symptoms resolve again, Just, the numbers are kind of all over the place, and so it would be hard to have a definitive answer there. It does seem to be, also, as was mentioned, with a radiculopathy versus a myelopathy, a little bit better outcomes with conservative care. Some of the systematic reviews, I think it was the first article, the Failings article, was looking pretty specifically at cervical myelopathy and they had pretty strong evidence to support surgery for moderate and severe myelopathy. And then there was just really a lack of evidence.

And the evidence that was available was not the best quality evidence discussing conservative care versus surgery for more mild levels of myelopathy.

What is interesting is despite kind of the lack of evidence, several of the studies that were on that reference list that pertain to this question did still recommend, whether it be related to radiculopathy or a mild myelopathy, a trial of conservative care before moving into surgery. But not necessarily a recommendation backed by the evidence my thought is, they were thinking, it's, obviously. They weren't necessarily at risk of doing harm by doing a conservative trial before moving on to surgery. So, they thought it might be warranted in those cases to see if it might make some improvement and then go from there.

But otherwise, I think Dr. Rundell summarized it really nicely, so.

Dr. David Somners:
Ok, thank you both, appreciate that.

With that, I think we've, we've dealt with A and B, as well. I think we'll move on to question two. You sort of hit on it a little bit.

But I'd like a little more discussion and it reads, "Is there evidence or society guidance regarding the use of alternative procedural treatment modalities prior to the use of cervical fusion such as (laminoplasty, arthroplasty, foraminotomy etc.)?" And we'd ask Dr. Shivers and then Dr. Mende also comment about this too. Please.

Dr. Joseph Shivers:
Dr. Mende, you're on a roll, do you want to go first?

Or I'm happy, too, as well.

Dr. Kristen Mende:
I can, sorry just to state my name again for the recording, Dr. Kristin Mende. So, I do think that Dr. Shivers might have a little bit more specific to add to this from the medical standpoint, but I can kind of resummarize, again, from the physical therapy piece of it.

That, again, there's not really any strong evidence regarding the use of that level of conservative care prior to fusion. But it does seem to be the studies that do exist, that seem to be in favor of it, are relatively low quality.

But there seems to be consensus from the authors, regardless that if it is a condition that, I hate to use the term more mild, because to the patient, it probably doesn't seem mild. But something that is a radiculopathy, or maybe a mild myelopathy, it might be worth a trial of more conservative care prior to moving on to surgical intervention.

And interestingly, one of the studies that compared surgery to conservative care, the individuals that were classified into the conservative care, were given the option after the trial ended to go ahead and proceed to surgery. And actually, a relatively low number of them opted to actually undergo surgery.

So, again, not strong evidence, relatively low numbers, but the authors felt that that might suggest it, while the relief received from physical therapy was not as significant as that from surgery.

Perhaps it was functionally enough to satisfy the patients to decide to forego surgery, and I will hand it over to Dr. Shivers for the rest.

Dr. Joseph Shivers:
Thank you very much. Dr. Mende well said. I again am Joe Shivers, I do not have any conflicts of interest.

So, the short answer is, as, as Dr. Mende said, nothing, nothing great.

The, the 20th reference by Bono and colleagues made reference to epidural steroid injections as having some level of weak evidence, suggesting that it maybe, provides relief for about 60% of patients based on their, six, based on their systematic review, and that, maybe, maybe the 25% of people with, who would otherwise have surgical indications for cervical radiculopathy are able to get relief.

I should of sign posted that a little bit better and made it clear that I'm referring specifically to cervical radiculopathy there that, that epidural steroid injections maybe help with kinda buying people time for cervical radiculopathy to get better on its own.

From that same paper by Bono and colleagues, the 20th reference on the list.

They say on the bottom of page 66, quote, "It is likely that for most patients with cervical radiculopathy from degenerative disorders, signs and symptoms will be self-limited and will resolve spontaneously over a variable length of time without specific treatment."

And so, for cervical radiculopathy, there's not as, there's not nearly as much data on cervical radiculopathy relative to lumbar radiculopathy. But the data on lumbar radiculopathy are pretty favorable, in that the vast majority of people will have good motor recovery and significant improvement in pain over the course of weeks to months.

And so, I think of conservative care in cervical radiculopathy largely as just sort of buying time, for the natural history to take effect.

The natural history usually being favorable, and then that part of conservative care is monitoring to make sure that people don't have progressive neurological deficit or pain that is just so intractable that, that they need the surgery from the perspective of pain relief.

For cervical myelopathy, I do not understand epidural steroid injections or really any other sort of procedural treatment to be indicated and tend to think that the role of conservative management is simply to monitor.

As Dr. Rundell said, the course of an anticipated decline in myelopathy is not necessarily clear for the population as a whole let alone for an individual patient.

And so, I think of the role of conservative care and myelopathy again as, as essentially being watchful waiting with the only real treatment option being surgery.

Dr. David Somners:
OK, thank you very much for excellent, both of you are excellent summary. I think question three we talked a little bit about, but Dr. Rundell, I would just ask if you have any other comments. In this regard, "Are there circumstances where conservative treatment may not be appropriate?"

And again, I know Dr. Shiver's just mentioned some of those, but perhaps you could opine on some other instances as well.

Dr. Sean Rundell
Yeah, certainly, so this is Sean Rundell. Traditionally I think people feel coming out with surgical conditions, especially if they have symptoms consistent with radiculopathy or myelopathy.

We look for, basically, look for red flags, so we're looking for people that may have a fracture or trauma that resulted in a fracture.

We're looking for signs and symptoms consistent with malignancy, or spinal metastasis to the spine, infections, and then the specific to myelopathy I guess we're also, that's just not looking, [inaudible] myelopathy but do they have pretty significant and concerning neurological impairments where they may need a, they may be having more rapid deterioration and be, need more urgent surgery, so things as a spinal cord injury or a bit more significant spinal cord compression.

So those scenarios or traditionally I think that either additional investigation needs to be done before conservative care could be decided if it was appropriate or not.

And things such as MRI [inaudible] for medical, medical evaluation, or they may be more appropriate for surgery based on those presence of those conditions.

My impression is a lot of the evidence are those fairly standard clinical practice.

There is not a lot of strong evidence and clinical trials is more based on, awareness of the potential risks, and then try to minimize those risks in consensus around that.

Dr. David Somners:
OK, excellent, thank you for that summary as well, Dr. Rundell. We'll move on then to the next question, number four, Dr. Shivers. This would be your question, "What is the evidence and/or society guidelines concerning factors likely to influence surgical outcomes?" And here, we're kind of, for example, behavioral risk factors such as smoking, opioid use, things like that, if you would care to comment on that. Thank you.

Dr. Joseph Shiver:
Sure. Thank you.

This is Joe Shiver's again. So, the two papers in the bibliography that most spoke to these questions, I thought were the 10 and 11 the Harrop and Kang and I'll talk about the number eight, the Enquist one a bit as well.

In the Harrop study they talked about hemoglobin A1C, obviously, as a continuous variable that reflects diabetes control, the worst diabetes control tends to pose a higher risk of adverse outcomes.

They noted 7.5% as the A1C, where there's sort of an inflection point in that curve, but it didn't sound like that was a hard and fast or a cutoff so much as a, if they had to pick a cutoff that was, that was the one where it made the most sense.

BMIs seems more relevant from the perspective of risk of deep tissue infection, wound infection, and posterior surgery than anterior surgery in the Harrop paper. But then Kang and colleagues cited a study in which BMI was associated with a higher overall rate of perioperative complications.

Smoking seems to be a very well accepted risk factor for pseudoarthrosis as referenced in both the Harrop and Kang papers. I was surprised to learn in the course of this review that there is not great evidence that smoking cessation is of any benefit.

The surgeons that I work with, or that I, that I know of I guess I don't work with surgeons so much as refer to them sometimes, the surgeons whose notes I see seem to insist on smoking cessation anyway before fusion surgeries that are elective. In terms of, in terms of the Engquist paper, which I guess there were two Engquist papers, references eight or nine, eight and nine.

There were a couple aspects of them that made me skeptical of their utility.

One was the relatively small sample size.

One was the fairly loose definition of radiculopathy where people basically just had to have arm pain and sort of neuro frame lost stenosis somewhere on the, on the radiology, which sort of everyone does.

They didn't necessarily need to have kind of correlating weakness or sensory deficits, which I think raises the question on the part of the reader of, you know, what exactly these people did have.

And then, there were a couple other aspects of their conclusions that sort of went against the conventional wisdom, one of them being that anxiety was a positive prognostic factor.

For surgical outcomes and another was the neck pain responded more to the cervical fusion than arm pain did.

So, so I, by contrast was sort of trained to think that anxiety, depression tend to be negative prognostic factors.

Just looking last night, I found a paper by a Strom, S-T-R-O with a diagonal line through it, -M, Bjerrum and Nielsen and colleagues and from the Spine Journal in 2018 that sort of spoke to the adverse prognostic effects of anxiety and depression prior to surgery and talked a bit about how information and expectation management can be, can sort of mitigate those risks a bit.

I think that there's a much larger body of literature there and I'm sorry, not to be more specifically familiar with it.

But sort of on a related note, I think, also from my training and clinical experience that patient's understanding of what they're getting into is important. And so, if the, if the purpose of the surgery is really to prevent deterioration of mild myelopathic symptoms and not to address neck pain.

But the patient thinks that the purpose of the surgery is to address neck pain and then their neck pain doesn't get better after the surgery that, that bodes ill for their satisfaction.

And so, I think that the expectation management and stress management and helping people to make decisions about their care from a place of rational analysis, rather than desperation, is an important point of conservative care whether it's explicitly, pre-operative, or assertive alternatives to operation, or helping people to make that decision. With regard to opiate use, that didn't seem to be addressed, head on in the, in the, the references that were highlighted for this question.

And again, I just found a couple, I think there's a larger body of literature on this and lumbar surgery, but for cervical, I found a paper called, "Pre-operative Opiate Use Leads to Increase Post-Operative Opiate Use and Re-Admissions After Anterior Cervical Diskectomy Infusion" by Chung, C-H-U-N-G and colleagues, it was published in The Journal of Spine Surgery in 2022. This was a single center, retrospective cohort study from Loma Linda with 102 excuse me, 198 patients, 102 of whom were opiate naïve, 66 with opiates less than six months and 30 with opiates more than six months.

And the folks who were on opiates for longer periods had a much higher re-admission rate in the 90-to-365-day post-op period.

And they also had a much higher rate of opiate use over that same period suggesting A) that surgery doesn't necessarily help people wean off opiates and, B) that for people who have been on opiates for more than six months that, that they might do worse post operatively.

And then there was another recent paper by Samuel and colleagues in the journal that's just called Spine, from 2021 which was, "Association of Duration of Preoperative Opiate Use with Reoperation After One-level Anterior Cerebral Discectomy and Fusion in Non-myelopathic Patients."

And so, this was an analysis of a private insurance database. They had 445 patients undergoing single level ACDF. The patients were not my myelopathic.

Two thirds of them were taking opiate meds before surgery.

For, for the, for the one third of patients who are opioid naive, their five year reoperation rate was 4.7% and then for patients who were on opiates chronically beforehand, the reoperation rate at five years range from 15% to 25% depending on that, the opiate agent in question.

So, so, you know, seeing surgeon's notes and occasionally talking to them about this stuff or shadowing during my fellowship year, it seems like, surgeons really try to wean people down who are on high opiate use. Which is sort of a separate question aside from the duration.

But it seems like perioperative pain control tends to be harder when people are already on a very high chronic opiate load.

So that, that doesn't necessarily change the decision of whether to operate but sort of influences the decisions around when, I think.

Dr. David Somners
OK, thank you, Dr. Shivers, so thank you also for summarizing those opioid studies.

We'll move on to the next question then, "What criteria do you consider before offering cervical fusion surgery?" It looks like you're up again, Dr. Shivers. There are sub parts to this as well and I'll read those for ratification.

Part A- "What degree of pain or functional disability are you looking at and how do you measure that?" and then, "What sort of radiographic imaging would be consistent in, that you would want, or the literature would support to be consistent with a surgical candidate?" Thank you.

Dr. Joseph Shiver:
Sure, thank you.

To, to my surgical colleagues on the call, I want to make it clear that I am not so hubristic as to presume, to offer surgical fusion, since I do not do surgery.

But I certainly do sometimes recommend my patients to, to speak with surgeons and try to facilitate a warm handoff and can certainly speak to my decision making around that.

So, so, the first question for me is, you know, do they have a diagnosis and, you know clinical presentation that's sort of amenable to surgery.

And I think we've all so far, all of us, non-operative folks have been speaking mainly about radiculopathy and myelopathy.

I know I'm a non-operative, not really, particularly interventional physical medicine and rehabilitation physician.

And I'm mostly seeing people in chronic pain, so it is vanishingly rare that I see traumatic instability, or multi-level cervical [inaudible] fusion, like in the few [inaudible] ankylosing spondylitis or malignancy.

And so, once again, I'm, I'm really, within this answer, sticking with cervical myelopathy, cervical radiculopathy and that what we're calling central spinal stenosis, this sort of incidental radiological note made of spinal cord compression without any symptoms or signs of that, as yet.

So, for myelopathy, you know clinic, clinically myelopathy, just to, to sort of frame how I think of that clinical presentation, that's symptomatic, usually, you know, some, some level of symptoms in terms of fine motor deficit or even if it's subtle sort of gait and balance, feeling less steady on your feet, tripping, slipping.

In terms of the fine motor, I ask about difficulty with knots and buttons, you know, if they're dropping things, bladder changes, in terms of their perception there, numbness, [inaudible], receptive deficits.

And then in the signs I would look for on physical exam include gait imbalance. And I try to increase my sensitivity by having people walk heel toe to sort of tandem gait.

Looking for weakness, which I would say is usually relatively late sign hyperreflexia, including Hoffman sign, deep tendon reflexes at the upper and lower extremities looking for that the Babinski response.

I'll check vibration and/or appropriate reception if I'm concerned about myelopathy.

The, I don't, for me and my clinical practice is honestly a bit more of a sort of [inaudible] and, you know probably like many physicians, there's some variability from the day to day in terms of how I approach it and some variability based on, you know the, the other patient specific factors.

That said the modified Japanese Orthopedic Association score is, it seems like a pretty good one in terms of classifying the severity as myelopathic symptoms.

I would say, and then in terms of the imaging, I would certainly get a cervical MRI or if that were contraindicated for some reason than a CT myelography.

Electrodiagnostics don't help you, or an EMG, nerve conduction studies at least don't really help you with cervical myelopathy because it's an upper motor neuron lesion.

So, if the MRI shows severe cord, severe canal stenosis, severe spinal canal stenosis with or without cord signal change, and there are, there's a clinical picture like I described.

I have a pretty low threshold to refer, to refer patients, at least to speak with the surgeon and sort of learn what their options are and, and put a face to a name and sort of know who they're going to call if they get worse.

If people are clearly, deteriorating, or more symptomatic than or if, I had one patient who did have a recent onset of myelopathic and radiculopathic symptoms after a traumatic injury and I referred her very quickly to surgery with a strong recommendation that she consider surgery, which she ended up getting. You know, many patients are more in that sort of gray area where you try, like the, like the Fehlings paper that reference number five talks about you try to sort of educate people as to the potential risks and the benefits and the uncertainty and the idea that surgery is largely a resting decline, more so than more so than fixing things.

Or at least in terms of like the purpose of it and that it's not without risks.

But, but, you know, I think, depending on how risk averse people are, or what needs they have to preserve their function and, and how clear the picture is.

I have a pretty low threshold to refer to a surgeon if the patient does have cervical myelopathy, or at least if I think they do. For surgical radiculopathy, the, the Engquist papers, like I mentioned in the Bono guideline, which is reference 20 both, have fairly loose definitions of what surgical radiculopathy is for me and my own practice.

I try to, I try to get the ducks in a row in order for myself to call it a cervical radiculopathy.

I like to see a pretty clear dermatomal pain pattern with at least some degree of correlating sensory and/or motor signs.

If the MRI is, shows a big disc herniation at the relevant nerve root level, then that's helpful.

If they're sort of mild neural foraminal stenosis everywhere that, doesn't help me as much, or if there's, you know, or if the foraminal and are wide open, if there's truly no impingement of the nerve root, that would steer me away, obviously.

If it's sort of intermediate than sometimes I'll order an EMG nerve conduction study to try to characterize that.

Or I supposed I would, I don't know that I've necessarily been in that situation. But certainly, there's other entities that can cause arm pain, shoulder, gleno-humeral pathology can radiate a little ways down the arm.

Median mononeuropathy, ulnar mononeuropathy, brachial plexopathies can, can be mistaken clinically for cervical radiculopathy so I don't, I don't think an EMG is always required.

I think an MRI once again, is sort of, is sort of mandatory, or CT myelogram, if the MRI is not an option. EMG I think kind of helps you on edge cases.

But I wouldn't, I wouldn't say that it's a, it's a must have for the majority of patients, certainly.

And then, so based on we talked a little bit earlier about this sort of consensus, that the natural history of radiculopathy is usually pretty favorable.

And so, within that understanding, the way I was trained to think about the indications for surgery are really that it's either intractable pain, or a progressive neurologic deficit. So, so weakness is not necessarily an indication for surgery but weakness that is worsening I would say is.

And, you know what is intractable pain to me, that's in the eye of the, of the patient I think, again, there's a role for shared decision making and helping people understand that, you know, better days are usually ahead and that there are options in terms of analgesic medications whether that's [inaudible] said sometimes for, for acute radiculopathies I will prescribe opiates, I don't really do that otherwise. But because the natural history is favorable if I have a patient who I think is a low risk of addiction and I just am trying to get them over the hump for those few weeks while the pain is really bad. I think opiates are a reasonable consideration.

I think the epidural steroid injections are a reasonable consideration.

But, if, the pain isn't getting better with the, with that non operative care or if the patient is just in so much agony and really, really wants to see a surgeon or, again, if they have a progressive neurologic deficit, those are all circumstances where I would refer to, refer to surgery. With regard to the central spinal stenosis without radiculopathy or myelopathy, I wouldn't typically send those patients to a surgeon, unless the patient really wanted to have that conversation, or I thought they were of unusually high risk of progression.

I think you know this one of the things highlighted in this literature review was that ossification of the posterior longitudinal ligament, which is a radiologic finding on a TTR x-ray scan is a is a worst prognostic factor in terms of the progression of asymptomatic cord compression to clinical myelopathy.

In general, my training and my clinical practice agrees with the Fehlings kind of recommendations, which aren't particularly evidence based, but almost more philosophical, which is that the risk of somebody developing myelopathy is a bit uncertain and the risk of intervention is small but non-zero.

And you don't really know whether somebody's going to progress or how fast they're going to progress.

And so, so for that central stenosis again, I would, I would tend to think that watchful waiting is, is best but would, would certainly, you know, have the conversation with the patient and kind of try to engage them in that shared decision making and if they you know if they really wanted to talk to a surgeon and I would facilitate the referral.

Dr. David Somners:
OK, thank you very much. Dr. Shivers. I'm going to hand it over to Dr. Moynihan in just a moment here.

Dr. Ratliff, I believe you might have had a question or comment about one of the questions. I'm sorry, I didn't see it before. I apologize. We have a couple minutes if you would like to ask that or direct, address that before we move on to the surgical questions.

Dr. John Ratliff:
Hi this is John Ratliff one of the spine surgeons from Stanford, can you guys hear me OK?

Dr. David Somners:
Yes, we can.

Dr. John Ratliff:
Fantastic. Sorry about the trouble with the audio PIN before, but I was able to get in. Just a couple of quick comments. So, this is a great discussion, and very thorough review of the literature.

And I think a very thoughtful approach to discussing these focused questions.

With regards to smoking use from the last question, I would hesitate to adopt that as a hard restriction, with regards to coverage policy or anything that incorporate into an LCD or NCD approach.

We have patients with severe myelopathy with severe cord compression who are smokers who simply can't quit, and where withholding surgery for their cord compression based on their smoking, would not be optimal treatment for the patient. Well obviously, smoking and nicotine use is likely an independent predictor of poor fusion and impaired surgical outcomes. With regards to the criteria for offering cervical fusion surgery that Dr. Shivers just did fantastic job of reviewing. I'd only offer that CT scan in conjunction with MRI, maybe not CT myelogram, but a CT scan in isolation. Oftentimes will give us very useful clinical information with regards to a surgical planning. We can see facet arthropathy and degrees of foraminal stenosis on a CT scanning, that we may not see on an MRI, or a CT scan just gives us, or at least, as I tell my patients, it's just another piece of the puzzle. It's another way to understand fully what's going on with the patient's spine, and I've certainly changed my operative strategy based on a CT scan in multiple patients, not only in patients with OPLL but also in some patients with just more basic cervical radiculopathy or more basic cervical pathologies.

The only other note I'd make from question five would be the value of an EMG in patients with myelopathy. Certainly, any spine surgeon will have surgically treated people with myelopathy who previously had a carpal tunnel release and previously had an ulnar nerve release and finally, they had imaging of their cervical spine. And they were found to have cervical stenosis and they were referred for treatment of their primary condition, which is their cord compression or cervical spondylite and myelopathy. However, having an EMG and having an understanding in a myelopathic patient if they had coincidence carpel tunnel, or coincident ulnar neuropathy is extremely helpful, and it's extremely helpful for a global approach to patient symptom complex.

And certainly, those conditions are not an either/or. Sometimes we'll be able to demonstrate the severity of a patient's myelopathy by ruling out of peripheral nerve compression, or ruling out an entrapment neuropathy, which sometimes EMG can do. So, all EMG I think is more helpful, more diagnostic, and more confirmatory in cervical radiculopathy patients.

[inaudible] myelopathy a place to role and sometimes we will learn in our myelopathic patients, important clinical information with an EMG.

And thank you again for that great review.

It's a good coverage of two very broad questions and a lot of content. Great job, Dr. Shivers.

Dr. Joseph Shivers:
Thank you for your kind words.

Dr. David Somners:
Thank you, Dr. Ratliff.

Dr. Joseph Shivers:
I would, I would, I would agree a 100% with what he said, about the, the non-contrast CT scan, that has, I think, in terms of advising patients on whether to get surgery, the CT scan, isn't necessarily that helpful for me as a non-surgeon. But I, I agree that the, that the surgeons that I am aware of, will routinely order CT scans and, and know that that is an important factor in terms of their operative planning, if not the binary of whether or not to operate.

Dr. David Somners:
Well, thank you both, for your comments. I really appreciate it. I'm going to turn it back over to Dr. Moynihan.

Dr. Moynihan:
Thank you. Before we get started on the surgical questions, Dr. Ratliff, because you had some issues with your audio PIN which I have often had myself, could you please just announce yourself, and where your field of specialty is. Where you practice and whether you have any conflicts because we need that for the record.

Dr. John Ratliff:
I'd be happy to and apologies for the difficulties to the audio PIN before. My name is John Ratliff. I'm a neurosurgeon, specializing in spine surgery. My practice is probably over 90% spine, mostly adults and mostly degenerative with both cervical and lumbar procedures.

And things to the entirety of the spine, I practice at Stanford University. I had conflicts that I shared before, none of which are material for the discussion we're having today about cervical fusion.

Dr. Moynihan:
OK, then we are going to proceed to question number seven, because as I previously stated, we moved number six to the end of the discussion.

"Does anterior cervical decompression with fusion (ACDF) result in better outcomes (clinical or radiographic) than anterior cervical decompression (ACD) alone?" Dr. Kellogg.

Dr. Kellogg, are you having trouble unmuting?

Dr. Jordi Kellogg:
Yes. Thank you. This is Jordi Kellogg. The citations, or citation that was most relevant to this question was by Dr. Bono at Brigham, which was a summary of the NASS Evidence Based Guidelines.

And the study that was the strongest study, answering this question was by Dr. Xie, X-I-E, pardon the enunciation, if I got that wrong. And that was a level two evidence that demonstrated that anterior cervical discectomy and anterior cervical discectomy fusion, had similar clinical outcomes.

And the second portion within the same question is, radiologically is there a difference and radiologically the ACDF was found to have improved lordosis with the anterior cervical discectomy frequently developed a kyphosis and what I found surprising in reading this was or not so surprising I guess, that the part of the desire I suppose for anterior cervical discectomy is preservation of motion, that 70% of them go on to fuse on their own anyway, with the kyphotic deformity and there's really no studies that I found demonstrating changes as far as the adjacent level disease with the ACD versus ACDF. Revisions were higher but not part of this study.

There were other studies that were weaker, level three studies. The level. The two citations in Dr. Bono's Paper were from Dr. Xie and Dr. Barloker which was a class Level three study and both of those demonstrated improvement in the lack of not developing kyphosis with an ACDF versus an ACD.

Thank you.

Dr. Eileen Moynihan:
Thank you, Dr. Kellogg. Are there any questions from the panel members, or comments, or from the Contractor Medical Directors and please state your name before you speak.

None? Okay.

Dr. John Ratliff:
Hey, it's John Ratliff, sorry about that. I raised my hand. I don't think this raising hand thing is working.

Dr. Eileen Moynihan:
I'm not sure that I'm seeing it, but I'm relying on folks to tell me that somebody's hand is up.

Dr. John Ratliff:
I like to quickly say that there is some very like over 20 year, 25 year old papers looking at anterior cervical discectomy versus anterior cervical discectomy and fusion.

And papers that note similar clinical outcomes in the anterior cervical discectomy group.

Compared to an ACDF without an anterior cervical plate.

Again, these papers are from over 20 years ago.

Happy to share them if it will be a benefit for the CAC.

It's definitely something over the history of medicine.

What was seen in the anterior cervical discectomy alone group is the patient would generally proceed to a fusion, but they proceed to a fusioning kyphosis like developing a mild deformity at the side of the discectomy as the two vertebral bodies would collapse into each other and then proceed to arthrodesis.

We've learned the hard way that leaving patients in kyphosis clinically can produce suboptimal results. Hence, the interest in fusion technology and implants that decrease subsidence, that decrease the risk of kyphosis and to maintain cervical alignment in the pain population.

Dr. Eileen Moynihan:
Thank you. Any other comments?

All right.

Then I'm going to move on to question eight, "What is the evidence and/or society guidelines concerning the efficacy of cervical total disk arthroplasty (disk replacement) compared to anterior cervical decompression with fusion (ACDF)?" This is Dr. Slavin and anybody who's not speaking, please go on mute.

Are you having trouble unmuting, Dr. Slavin?

Is he on at the moment?

Dr. Kontantin Slavin:
Can you hear me?

Hello.

Dr. Eileen Moynihan:
There you go.

You must have unmuted yourself. Thank you.

Question eight.

Dr. Konstantin Slavin:
Thank you very much for waiting for me. I apologize for the microphone issues.

Can you hear me well now?

Dr. Eileen Moynihan:
Yes.

Dr. Konstantine Slavin:
Excellent, excellent. So, so the question was about the evidence, or society guidelines, concerning efficacy of cervical disc arthroplasty requests, I'm just reading from the screen, right now.

And I gotta tell you that the cervical disc arthroplasty has been introduced about 20 years ago or so, as an essentially, an alternative treatment for cervical disk degenerative diseases.

With a mobile device between two vertebral bones, the mobility of operated segments can be preserved, and that may potentially decrease the incidence of adjacent segment disease.

Moreover, the arthroplasty was reported to show better improvement in clinical functions compared to fusion surgery, because the normal kinematics of the involved segments. The numerous studies have compared clinical results and complications, but the conclusions unfortunately are not completely consistent, but nevertheless they're very positive overall.

So, if you look at the references that were provided with this request, they reference 32, which is Dr. Mummaneni's paper from 2012.

A summary of systematic review of two FDA trials that were reporting outcomes following cervical disk replacement with Bryan and Prestige disks versus, and anterior cervical discectomy infusion, and 4 and 5 years.

They clearly establish that arthroplasty is a viable treatment option for cervical herniated disc and spondylosis with radiculopathy resulting in improved clinical outcomes, maintenance of normal segmental motion, and low rates of subsequent surgical procedures.

Subsequent to that, there were several other papers, including paper by Dr. Hisey which is mentioned here as reference 21, and two other papers by Dr. Jackson and Dr. Ratcliff.

They were not included in the summary, but I'll be happy to send them if needed.

And all of this paper is analyzed for 5- and 7- year results of randomized prospective comparison of cervical arthroplasty with [inaudible] disc versus ACDF and the papers were published in 2015, 16, and 17, respectively.

They discovered that, although both interventions, the cervical disk arthroplasty and cervical discectomy and fusion result in significant improvement in neck disability index scores and pain measured by visual analog scores.

The arthroplasty patients maintain motion and had significantly lower rates of reoperations and adjacent segment degeneration compared to ACDF.

In addition to this, the last study from 2017 showed that two level arthroplasty demonstrated clinical superiority over anterior cervical discectomy and fusion where a single level arthroplasty was non inferior to ACDF.

Of note, the 88% of patients with ACDF in more than 95% of patients with arthroplasty where inputs are very satisfied at seven years after surgery.

There was meta-analysis by Dr. Zhang listed here as reference 24, which was published in BMC Neurology, and this meta-analysis summarized 13 randomized controlled trial studies with more than 60 months of follow-up.

The poll results indicated that cervical arthroplasty group exhibited significantly better outcomes and clinical scores and preservation of range of motion than ACDF group.

Meanwhile, the incidence of adjacent segment disease and occurrence of reoperation were lower in the arthroplasty group compared to ACDF.

There was a recent paper by Dr. Zhang in Frontiers of Surgery, published in 2023, it's not included. I'll have to send it over, it's an open access.

That reviewed eight randomized controlled study that focused on very specific cervical disc. Discover, and they show that both arthroplasty and ACDF have similar results in terms of neck disability index scores, pain scores, quality of life scores, and dysphasia.

In addition, arthroplasty could reduce risk of adjacent segment disease but increase risk of reoperation.

Similarly, the 2023 systematic review and meta-analysis of randomized clinical trials were more than a minimum follow-up of 7 years, which is here listed as reference 23.

Compared cervical arthroplasty and anterior cervical arthrodesis, it was published by Dr. Nunez and colleagues and they analyzed results of 2664 patients found significant improvements in both groups with higher emotion rate, higher overall success rate, higher improvements in neck disability index and less VAS arm pain in arthroplasty patients compared to ACDF.

There was no significant difference in neck pain scale or adverse events, and finally the 2021 the randomized clinical trial, which is here under reference 22, by Dr. Johansen in Norway that was published in JAMA, compared a total of 136 patients with five years follow-up in 84%

The authors conclude that patients treated with arthroplasty and fusion, have similar and substantial clinical improvements in five years.

So, in preparation for today's conversation, I looked at the guidelines from the societies and I didn't see any specific mention of arthroplasty versus cervical discectomy and fusion as a treatment option, but there's plenty of recommendations for anterior approach for treatment of a variety of surgical pathology and I think we'll talk briefly about this later when we discuss cervical myelopathy.

So, I believe there's plenty of evidence to suggest that both of these modalities are effective.

There, there's some controversy which one is effective in terms of one parameter or the other.

But they are definitely not inferior to each other in the cervical disk replacement for specific indications in the specific patient cohorts is definitely valid option which is on par with discectomy and fusion. That's it for this round.

Dr. Eileen Moynihan:
Thank you.

Are there any comments or questions from the CMDs or panelists?

Dr. Vincent Traynelis:
This is Dr. Traynelis from RUSH, that was an excellent review.

I just want to make two comments.

The first is, if we look at the data at two year, there's not much difference. And, really, the break point comes at 5 to 7 years where arthroplasty pulls ahead in terms of the need for less surgery.

The second is, it looks good. But all patients do not qualify for arthroplasty. This is a subset of patients that, that need anterior decompression it's a select subset. So, we can't generalize arthroplasty to all patients presenting and with anterior pathology.

Dr. Konstantin Slavin:
These are wonderful comments. Thank you very much, Dr. Traynelis I mean, I don't think anybody on this call has as much expertise as you in these areas, so, so I fully agree with you, and I think it makes perfect sense.

Dr. Eileen Moynihan:
OK, thank you.

Moving on to question number nine.

"What are the indications for single versus multi-level fusion, and what are the limitations for the number of levels fused?" Dr. Traynelis.

Dr. Vincent Traynelis:
Well, let me, let me start by saying that the indications for single versus multi levels are a little bit based on the pathology.

It is possible, but unusual, to have three levels of disk creation causing radiculopathy. This is a usually a 1 or 2 level problem whereas, with myelopathy in the setting of congenital stenosis is more frequently a multi-level disease.

So, the type of pathology being treated will impact the number of levels in which surgery is required.

If we look at the anterior data, and, and now focus on myelopathy because these are patients that are going to have multiple levels, there is a trend of surgeons to limit the number of levels they do anteriorly, a number of studies two maybe three, and if patients required more than three levels, they chose posterior approach, and the reason was twofold.

One is concern for dysphagia. The dysphagia data, and it's listed, it was touched upon with complications is, is really a little muggy, because when we look at studies of anterior surgery and dysphagia rates, post operatively, no study details, how many patients had dysphagia prior to surgery.

And almost no study uses a validated measure of dysphagia. It's simply a question, how do you swallow so, so, we don't really know what is the actual rate. There's no question. There is there is some problem early on.

How serious, how long it lasts, it's not fully defined. The other is the fusion rate, though, from the articles supplied in the review, as well as multiple other articles, it is clear that the more levels addressed anteriorly, the lower the fusion rate.

In fact, four and five level anterior surgeries, probably if we're honest have a fusion rate of 50%. And so, this is another concern with the anterior approach. If we look posteriorly, certainly it is mostly a multi-level disease that requires a fusion.

There is a historical body of literature, laminectomy alone, and probably at least a 20% kyphosis rate. Post laminectomy membrane syndrome is probably a sign of some sort of subtle instability, and all of these things can be eliminated with a fusion. So, multi-level posterior cases will frequently require fusion.

Not listed here was a posterior strategy laminoplasty, it's a non-fusion strategy, and, and it is very beneficial in select patients. These patients cannot have instability. They cannot have a number of factors, including facet arthropathy. But, in, in select patients, the, it is an excellent treatment just as arthroplasty a non-fusion technology for anterior surgery is an excellent, excellent strategy.

And so, the considerations are how many levels and, and, and whether the pathology is anterior or posterior. OPLL primarily anterior pathology can be treated with posterior decompression if the OPLL is not extending into the center of the spinal canal.

But most other degenerative anterior pathologies or at least many of them if they are, if there is significant anterior cord compression would require an anterior approach. Finally, not mentioned in here, there are there are combined strategies where an individual may get a 1 or 2 level anterior decompression. And then, this is for myelopathy, and then in a delayed fashion, if improvement is not noted and there's persistent dorsal compression, a dorsal procedure.

And, as I see it, these, these are the factors, and so, one approach is not superior to others, it will depend on the patient presentation and also some surgical surgeon experience, and in terms of what they have to offer.

Dr. Eileen Moynihan:
Thank you, Dr. Traynelis. Are there any comments or questions from the CMDs or panel members?

OK, moving on to Question 10. "What are the considerations for determining surgical approach (anterior, posterior, and combined)? Does evidence support one surgical approach as superior to others? If so, what evidence?"

I think we heard a little bit about this, but I don't know if you want to comment further, Dr. Ratliff.

Dr. John Ratliff:
Yes, I'd like to make a few comments on this. I think it dovetails very well with the other comments Dr. Traynelis just made.

I would say, just at the outset, there is not a one size fits all approach to cervical degenerative disk disease and a variety of pathologies in the cervical spine.

So, there's not, answering the question and really, evidence that there's one approach, that's superior to every other approach in every patient.

Each of these clinical decisions has to be predicated and based on the pattern of cervical degenerative disease and a pattern of pathology in a given patient, as Dr. Traynelis pointed that out.

For one- and two-level disease or one and two motion segments of cervical stenosis, cervical degenerative changes. Surgical bias is usually towards the anterior approach, because we classically we see fewer complications and quicker recovery with less pain. Utilizing any anterior approach.

As you get to three levels of disease, you see the fusion rate drop off. You do not have any three level cervical arthroplasty procedures that are FDA approved, and you start worrying about your approach related complications with an anterior approach in patients with kyphosis though, meaning of cervical deformity. Sometimes, a multi-level anterior approach is necessary, and in that subset of patients you may choose to do a combined approach, meaning both an anterior and a posterior stabilization out of fear of pseudoarthrosis or a failure of your fusion. Or, if you were to do a corpectomy or more extensive anterior decompression, fear of dislodgment, or migration of your corpectomy reconstructive, start grabbed or reconstructive cage.

So, looking through the articles, there's some very good literature that's reviewed in the bibliography. Probably one of the most interesting is, I think, citation 33 from the Bibliography which is Ghogawala's study from JAMA published in 2021.

He randomized patients with cervical spondolytic myelopathy who could be treated either ventrally, or dorsally, meaning either an anterior approach or a posterior approach, where he actually had surgeons review the studies, make sure the patient was a good candidate for either an anterior approach or posterior approach.

And he found in that study, essentially, no difference in overall outcomes. Of clinical recovery in the patients were comparable between either an anterior approach or a posterior approach.

Now, that's in a subset of patients who could be treated anteriorly, so, the most were, I believe, two and three level surgeries. He did see a higher number of complications with the anterior approach, with the most common complication being dysphagia. And here you run into the same issue that Dr. Traynelis pointed out that quantifying dysphagia is difficult and essentially everyone having an anterior approach the cervical spine will have some degree of dysphagia in the early post-operative setting, that may not have meaningful clinical impact, though.

Sattari's article, which is, I think, citation number 31, with a meta-analysis, looking at multiple studies, and again, trying to compare anterior and posterior approaches.

Here, again, the number of procedures were relatively low around an average level of three segments being fused in this meta-analysis, he managed to find 19 studies with over 8,000 patients. And a pretty even split between anterior cervical approaches and posterior cervical approaches.

His meta-analysis showed the clinical results are essentially similar. Both groups of patients had improvement with comparable outcomes. His conclusion was, quote, "The authors recommend individualized treatment, decision making." closed quote. A similar recommendation was made by Lee's study, which is citation 30, another meta-analysis.

And then the spine sections, recommendations, which are summarized in Dr. Hadley's articles, from neurosurgery from 2002, looking at spinal fractures which I know we'll get to in a later question. Again, notice that the operative technique depends on the patient pathology.

So, a long-winded answer to the question. I don't think there's a one size fits all approach, and either anterior approaches, posterior approaches, or combined approaches, is going to have good clinical outcomes, and the surgical approach needs to be tailored to the individual patient's pathology.

Dr. Eileen Moynihan:
Thank you.

Does anyone from the panel have any more comments or questions and/or the CMDs comments or questions?

OK, I'm going to move on to question 11. "What is the anticipated relief period following a cervical fusion and how often are surgical revisions necessary?" Dr. Kellogg.

Dr. Jordi Kellogg:
Yes. Thank you, Jordi Kellogg.

The citation, again, was Dr. Bonos paper, from The NASS Guidelines. And the study that was in the guidelines was rated a C, was at level three, was a Dr. Worth study. And it was 60 months follow up, that surgical or ACDF was, did provide long term treatment.

Two other articles that were added on. One is a Swedish study that had from a randomized trial that they performed a 20-year phone follow up, which had similar results of 88% favorable outcomes.

The, you know, I would say that most of us that do fusion, you know, once they are fused that that segment is static and doesn't become a problem in the future it's the adjacent level that becomes a problem. Regarding revision, the paper by Dr. Buyuk, B-U-Y-U-K, in the Journal of Spine Surgery, looked at revision for pseudoarthrosis, of course they could be a revision for a number of things. But in this paper, it was for pseudoarthrosis and it was comparing using a PEEK cage versus a Cloward technique. And what they found was results of pseudoarthrosis requiring revision of 8% for the allograft patients and 14% for the PEEK patients.

And, you know, in preparing for today, it was interesting to me that, you know many studies just because there's a pseudoarthrosis doesn't necessarily mean they're overly symptomatic or require a revision.

Not necessarily, that's how I do my practice, but it is, it is an interesting thought for me to consider. And so that's, that's what the three papers that were cited. That's, that's what I got out of that 18 to 14, 8 to 14% need for revision for pseudoarthrosis. Thank you.

Dr. Eileen Moynihan:
Are there other comments or questions from panel members or CMDs?

Dr. Vincent Traynelis:
This is Vincent Traynelis from Chicago, I just want to make a general comment on the Bono paper. This is a paper looking at the diagnosis and treatment of cervical radiculopathy, so this is focused not on myelopathy by radiculopathy.

And we should keep that in mind because I would suspect at least half if not more of the Medicare population are going to be treated for myelopathy. So, I just want to make that point.

Dr. Eileen Moynihan:
Thank you. Are there any other comments?

OK, and we are going to move on to question 12, which I think has been partially or somewhat covered before. "What surgical techniques are best for cervical spondylotic myelopathy?" Dr. Slavin.

Dr. Konstantin Slavin:
Thank you very much. And, yes, you're right. I would like to thank Dr. Ratliff for covering most of my answer for this question. But he did remarkably well. And if you don't mind, I'll just, I'll just briefly explain what's going on with myelopathies and what we are trying to treat. So, they, in general, the myelopathy is cervical spondylotic myelopathies and the most common problem with spinal cord dysfunction worldwide. It presents insidiously with clinical symptoms, which could be gait instability, bladder dysfunction, fine finger motor difficulties, as well as [inaudible].

Dr. Eileen Moynihan:
Excuse me doctor. Could anybody, could everybody who's not speaking, please mute. It's hard to hear him. Go ahead, doctor.

Dr. Konstantin Slavin:
Thank you very much. Yes, you're right. It's much nicer now.

So, the cervical myelopathy has both symptoms and signs, and signs could be hyperreflexia, weakness, alteration of appropriate reception affecting both motor sensory pathways, so neurological dysfunction results from, essentially dynamic repeated spinal cord compression from cervical spine degenerative arthritis, resulting in external stretch injury and spinal cord ischemia.

The surgery to decompress spinal cord, usually is fusion, is frequently performed for severe progressive symptoms, and the optimal surgical approach for cervical myelopathy essentially remains unknown. Clinical equipoise exists for randomized studies.

In the United States surgical practice, both ventral and dorsal decompression and fusion dominate in laminoplasty which was briefly mentioned earlier, remains lesser extent.

So back in 2009, the Institute of Medicine designated cervical myelopathy as one of the top 100 National Health Priorities for comparative effectiveness research because of this severity and importance.

The ventral fusion surgery, the surgery from the front has been associated with significantly better health related quality of life and less neck pain. And some inpatient databases showed a lower five-year adjusted reoperation rate for ventral fusion compared to dorsal fusions.

But in general, the answers is still open. As a matter of fact, there are some published guidelines from AO Spine North America and Cervical Spine Research Society that came out in 2017, and Global Spine Journal by Dr. Fehlings and colleagues.

There's also guidelines from World Federation of Neurosurgical Society as well as Italian Society of Neurosurgery in the neurospine this year, by Costa and colleagues. And those Japanese Orthopedic Association guidelines by Dr. Watanabe and colleagues in 2023, published in Journal of Orthopedic Sciences.

All of them recognize value of both anterior and posterior surgical interventions in patients with cervical spondylotic myelopathy. But they do not answer the question, which one is better.

So, in the United States the, the Journal of Neurosurgery Spine in 2009, published a series of papers covering each of these procedures separately. There was a paper on Cervical Laminectomy Without Fusion. There was paper on Cervical Laminoplasty, Cervical Laminectomy with Fusion, as well as Anterior Cervical Discectomy and Fusion Multiple Levels.

The summarizing paper by Dr. Mummaneni analyzed different surgical techniques for treatment of cervical spondylotic myelopathy specifically. And the overall conclusion was that multiple existing approaches result in similar, near-term improvements, but laminectomy, which is decompression without fusion, appears to have late deterioration rates that may need to be considered when appropriate.

The meta-analysis by Montana that was published in World Neurosurgery in 2019. I'll be happy to provide it. Suggested that ACDF should be preferred to laminoplasty for treatment of multi-level, cervical myelopathy but they noticed that there were no properly designed randomized controlled trials.

So, in order to determine whether ventral surgical approach, compared to dorsal surgical approach, for treatment of myelopathy improved patient reported physical functioning of the year. There was a study that was already mentioned by Dr. Ratliff. It was Cervical Spondylotic Myelopathy Surgical trial, CSMS. That was put together in multi center format. There were 15 centers in North America, 14 in US, one in Canada, with patients enrolled between 2014 and 18.

In the two-year data collection was completed in 2020 and the paper was published in JAMA in 2021. That's reference 33. With 458 patients screened, there were 269 enrolled and 163 been randomized, and they were randomized to three different options.

And they, after discovered that both ventral surgery was anterior cervical disk removal, and dorsal surgery was laminectomy and instrumented fusion, or open door laminoplasty resulted in significant improvements in both physical component of short-term SF 36.

Physical component summary score improved by 5 to 10 points at one and two years, and that was their primary outcome. The neck disability index scores improved by 10 to 17 points at one year, and 12 to 16 points, at two years, with all these interventions. That was their secondary outcome. And there was no significant differences between ventral and dorsal surgery.

Finally, the most recent meta-analysis, by Dr. Sattari and colleagues, that was published in 2023 is here as reference 31, which was also mentioned by Dr. Ratliff was focused specifically on comparison between anterior cervical discectomy and fusion versus posterior decompression.

It includes 19 studies and comprised of 8,340 patients. It found that cervical, anterior cervical discectomy and fusion and posterior decompression were similar regarding functional outcomes.

They both were very beneficial in terms of improvement by all available indicators. The anterior cervical discectomy and fusion was beneficial in terms of less bleeding, shorter lengths of stay, and lower odds of surgical site infection and C5 policy.

While, at the same time, it carried higher odds of dysphagia. This prompted the authors to recommend individualized treatment decision making.

So, I guess to briefly answer, the, which surgical techniques are best, I think what has already been mentioned previously makes sense.

It's said we individually tailor based on patient's anatomy and the radiographic findings. And the combination of MRIs and CTs seems to be the best guide in terms of choice of intervention. Because whenever it comes to kyphotic deformity which, they need to be addressed from ventral procedure or certain interventions that really need to be done in combined approach with both anterior and posterior stabilization. Those things have to be decided individually. The only thing that's, there's full consensus is that surgery definitely improves the patient's disability, their functioning and quality of life, as well as their pain levels. Thank you.

Dr. Eileen Moynihan:
Thank you, Doctor. Are there any comments or questions from CMDs or panelists?

Hearing none, move on to Question 13. "Does ACDF with instrumentation result in better outcomes (clinical or radiographic) than ACDF without instrumentation?" Dr. Traynelis.

Dr. Traynelis:
If we start with reference 20, which is the Bono paper, was there a conclusion that both ACDF with and without a plate were comparable producing similar clinical outcomes and fusion rates in the treatment of single level cervical radiculopathy.

They also stated that the addition of the plate was suggested to improve satchel alignment. And the greater recommendation for both of these was a B, the conclusion was that, although it may be indicated in some patients who are undergoing multi-level ACDF, there's insufficient evidence to practice results in significant improvement in clinical outcomes.

So, it's a little bit mixed in this paper, in that, with a single level. They don't see any difference, and they don't present much data with the multi-level.

And, the plate, there's a strong body of literature dating back decades, when plates first came out, debating this very issue and it is clear, especially with a single level the edition of a plate, does not add a great deal.

It does improve fusion rate with allograft and if there is a two-level fusion, then, fusion results unplated with autograft, iliac crest autograft versus Allograft are significantly different.

The addition of the plate brought the fusion rates in line. So, the plate allows us to perform multi-level fusions without subjecting the patient to harvesting their own iliac crest which has its own moderately high short-term morbidity.

And so, the plate does improve fusion rates. We can debate whether fusion improves clinical outcome overall.

But I would subject one to the position that if, if part of the procedure is to perform a fusion, then all should be done possible to make that fusion successful.

Not touched upon in this question but a related question is the standalone. So standalone devices are simply inter-body devices fixated to the adjoining vertebral bodies with screws but there's no plate.

There's robust literature that shows the dysphagia rate with the stand alone, is less than that with the plate. So even though the plates are only 2 to 3 mm in thickness, it's enough that will increase overall dysphagia rates.

The price of lowering dysphagia rates with an inner body though is subsidence. These devices are much more prone to subside and produce some kyphosis. The fusion rates between the two are similar.

And so, it is another type of instrumented anterior fusion, although not specifically with the plate.

So, in summary, today, most patients are treated with allograft, or they use inert spacers with a variety of bone products that, that, promote bone, growth, and fusion. And the plate clearly, at least with the allograft, improves our fusion rates when it's more than one level and decrease the subsidence rates as well if it's more than one level. And then that has led to the adoption of plating these anterior cases. And that's, that's my report.

Dr. Eileen Moynihan:
Thank you. Are there comments or questions from the CMDs or at the panelists?

All right. I'm gonna move on to question…

Dr. Konstantin Slavin:
This is. This is Dr. Slavin. I just wanted to make sure that people understand that this, this question about using instrumentation during anterior cervical fusion was much more relevant in the past when people did not use plates routinely.

These days, this is rarely done.

I haven't heard of cervical fusion done without plates. The standalone devices, Dr. Traynelis referred to, they have integrated plate and cage and some screws pull through this.

Back in the day during Cloward's time when this fusions were done without plates, that was a very relevant thing, these days I don't think it's relevant anymore.

Just my 2 cents.

Dr. Vincent Traynelis:
This is Traynelis. I completely agree a plated anterior case is, should be, I think it's considered the standard of care.

Dr. Eileen Moynihan:
OK, thank you for that additional information.

I like to move on to Question 14.

Some of this has been covered before, too. "Are their materials or methods that are superior to others, such as corpectomy vs discectomy, types of materials, use of plates, etc? Is there evidence to support the role for artificial disc?" Dr. Ratliff?

Dr. John Ratliff:
Thank you. I think I'm going to be much more succinct with this answer.

For the artificial disc I think we've actually already discussed that. Multiple commenters have already spoken to the studies, outlining artificial disc. I'd only say adding on to the comments that have previously been made on total disc arthroplasty that the key there is really patient selection and making sure that the patient is an optimal candidate for a total disc arthroplasty. The studies in that space are generally a relatively young patients.

The summary that Dr. Mummaneni has is one of the citations from 2012 has a very young patient population with an average age of 44 years.

So perhaps not relevant to Medicare beneficiaries, that'll be affected by the LCDs and NCDs that come out of this discussion.

We've also discussed at length the difference between corpectomy versus multi-level discectomies and Dr. Traynelis just spoke to the anterior cervical plating. So not a lot that I need to add there. I'd only offer like two additional articles. One is, I think, citation 31 from your guys' bibliography. I'm sorry, to citation 28, from your guy's bibliography, Hermansen's article published in 2023. It's a really interesting article on the 20 year follow up. In a small group of patients undergoing anterior cervical discectomy with two different techniques, either the Cloward technique that was mentioned, which is again, kind of a history of medicine technique utilizing a bone graft harvested via a circular reaming device from the iliac crest versus a more classic Smith Robinson. Which is, I think a surgical technique, that's probably a more commonly used today, than it was 20 years ago.

And here, autographed, meaning harvested from the patient's iliac crest versus a carbon fiber cage via a Smith Robinson technique, or compared. It's a very small patient population, but they showed good clinical outcomes. And essentially no clinical difference between the two techniques. I don't know that there is. Literature supports, certainly not from the bibliography that would support one technique over another. For cervical anterior, excuse me, anterior cervical discectomies and fusions.

It's very hard to find recent literature reviewing uninstrumented anterior cervical approaches. And because, as Dr. Slavin and Dr. Traynelis have pointed out the standard of care and kind of standard operating procedures for spine surgeons have really migrated towards utilizing routine anterior cervical fixation when doing anterior cervical reconstructions. I did find an article when I was looking around last night, which I can share. It is one where I would have to pull up the PDF, it's not an open access article. But it's from India, published in the Journal of Neurosurgery in 2002 Dr. Radshankar. And again, I can share this if desired.

But in this paper, they looked at around 90 patients undergoing cervical corpectomies either 1 or 2 level corpectomy. So, not just a discectomy but an actual cervical corpectomy where they did those in an uninstrumented fashion meaning they didn't augment that anterior cervical reconstruction with an anterior cervical plate.

And the study shows, and kind of illustrates why I believe you as spine surgeons have migrated towards anterior plates fixation and that's because the rate of kyphosis or development of an abnormal, or what most surgeon would consider a pathologic spinal alignment was approximately 35% in these patients. Meaning the loss of cervical lordosis and the development of a cervical malalignment was very common in these uninstrumented cervical corpectomies.

I think that it fits with the rationale or the reasoning behind the spine surgery community, moving towards, routinely using an anterior cervical fixation in this space. And I'll stop there. I know we have a big question six to tackle next.

Dr. Eileen Moynihan:
Are there any comments or questions from the CMDs or other panelists?

OK, thank you all for those answers and for moving us along. We are two hours into this call, and it is scheduled for another hour, not that I want you to take that time.

I'm going to turn this over to Dr. Somners to begin question six, which is sort of our lightning round.

Dr. Somners

Dr. David Somners:
Yes. Thank you and thank you to our wonderful panelists, and the experts today really have done an excellent job, I think, in summarizing the literature in this area.

Question 6 has a number of subparts, as you see there. I'm going to handle the first three A, B, and C and then Dr. Moynihan will bring it home with D and E.

Question 6 reads, "Is there evidence to support the efficacy and safety of cervical fusion surgery compared to non-fusion surgical procedures and/or conservative management for the following patients?" Starting with subsection A, the patient with unstable spine, cervical instability in the context of a cervical spine fracture or dislocation, trauma, or spinal cord injuries, or traumatic spondylolisthesis. And this is open to all the panelists. If you don't mind, please opine about on this topic, and then we'll move on to the other two or other segments. Thank you. Anyone can start.

Dr. Traynelis:
This is Traynelis. I could start. In terms of subgroup A, you, you mention instability. So, there are spine fractures, cervical spinal fractures that are not unstable or that are so unstable, they could be managed just with orthosis. And, and we all recognize what those are and treat them non operatively.

If there is true instability in the presence of a fracture, dislocation, injury, any of these things in spondylolisthesis then, then is unequivocally, this patient's candidate for, for surgery, and how the surgery is performed. Excuse me, would be based on the pathology, where the fracture is, where the dislocation is.

There's clear evidence that in the presence of spinal cord injury and compression of the spinal cord, that decompressing the cord is of value and decompressing the cord as rapidly as possible is of value. And these procedures invariably, then require fusion because there is injury, the decompression creates more instability, and so these, these are combined with fusions.

I'll just start with those comments.

Dr. John Ratliff:
I would echo those comments. This is John Ratliff from Stanford. I think for cervical instability, I mean, the definition of instability is lack, or the inability of the spine to serve, to protect the spinal cord and to protect vital neural elements.

Many of us become in the majority of patients a clear indication for surgical stabilization, surgical reconstruction, cervical, excuse me, surgical stabilization of that unstable fracture. Now there are subsets of patients where utilization of the halo, or utilization of that rigid, external, orthosis may be considered.

There are patients where I'm sure each of the surgeons on this this call maybe have started out utilizing a halo and then had to transition to a cervical fixation or cervical fusion surgery.

So, there's considerable heterogeneity in patients presenting with cervical fractures, both regards to the bony morphology of the fracture, but also, the presenting neurologic exam.

Whereas Dr. Traynelis notes a patient presenting with a cervical spinal cord injury, and focal cord compression are generally going to be of a much higher acuity and much greater need for timely operative intervention. Although sometimes we'll see patients with isolated facet fractures and more limited but still unstable, potentially, injuries who present with severe radiculopathy or [inaudible] motor deficits where the facet fractures producing foraminal compromise, each of which may mandate operative intervention.

Central cord syndromes, which are another population of patients. So, we haven't really discussed, here, are also a pathologic condition, relatively common in patients of a Medicare beneficiary age where surgical therapy and cervical fusion surgery is quite often considered a standard of care and quite often utilized.

Dr. David Somners:
Any other comments regarding unstable spine or cervical instability from the panelist, or the CMDs, or anyone else?

Hearing none. Any comments about this question with respect to cervical radiculopathy?

Dr. Vincent Traynelis:
Think, I think the Bono paper does address it, and we've discussed it in the context of all these other subgroups previously.

Not all radiculopathy requires a fusion. Some patients who are candidates for arthroplasty and a lateral soft disk herniation could be removed from a posterior approach without a fusion.

But many of these patients have a bony [inaudible] anteriorly and anterior pathology in addition to their radiculopathy, and they will require anterior fusion.

Dr. John Ratliff:
I would agree. I think, we, John Ratliff from Stanford.

I think, we have kind of discussed radiculopathy in the variety of different operative treatments relevant to radiculopathy where fusions are routine, tool, and kind of the toolbox that spine surgeons use for cervical radiculopathies recalcitrant to conservative treatment.

Dr. David Somners:
Yes, OK, excellent, thank you.

Sub, subpart C deals with cervical myelopathy in the context of spondylotic myelopathy, cervical myeloradiculopathy with sort of a mixed picture, and then mild myelopathic symptoms and signs. We may have covered some of that as well, previously. But any other comments about under this subsection C?

Dr. Shivers:
Just, I don't know that this is germane to the writing of the policy.

But it kind of, kind of in the, in with the myelopathy and in with the central spinal stenosis we've been talking about all these situations, like the diagnoses, is sort of clear.

And I think there are a lot of instances clinically, where somebody's walking a little bit funny, and maybe their reflexes are a little bit briskier than you expect them to be. But the imaging isn't totally impressive, and you're wondering if something else is going on, and there are certainly other neurological conditions that can cause deteriorations that could be mistaken for, or could overlap with, with myelopathy.

And so, I think that it's, you know, incumbent on all of us to, to, to make that diagnosis.

But you know, you can't, you can't do, you know testing for Parkinson's disease in everybody and you can't do an EMG to rule out ALS in everybody it's, it's more just, just sort of a side note comment on, you know, the importance of the clinical and radiographic picture, sort of fitting that diagnostic impression.

Dr. Eileen Moynihan:
Dr. Shivers, is that you speaking?

Dr. Shivers:
Oh, yes, I apologize, that was, that was Shivers.

Dr. Eileen Moynihan:
Ok, thanks.

Dr. David Somners:
Alright. If there are no other comments or questions, I'm going to turn it over to Dr. Moynihan for the final sub section.

Dr. Eileen Moynihan:
All right. We're on central spinal stenosis.

Are there comments about central spinal stenosis in the same question.

Dr. Vincent Traynelis:
Vince Traynelis from RUSH. So, central stenosis, in the absence of myelopathic symptoms or signs, is a topic of interest in our literature.

There are fairly clear evidence that surgery is not indicated in these patients. The risk of catastrophic deterioration is very small, and when compared to maybe the risk of surgical complication, the margin is more narrow.

So, these patients if they have severe stenosis, do concern us. And, and there may be times that SEP testing may help us. If there's electro physiological posterior cord dysfunction, despite our exam being normal, may push us to act.

But in general, if we took all comers with central stenosis and essentially no symptoms, these people are not usually surgical candidates.

Dr. Eileen Moynihan:
Are there any…

Dr. John Ratliff:
John Ratliff from Stanford. The only pushback I would offer on that is that all of these patients are getting imaged for some reason, meaning that we're not doing MRI screenings for people.

So, generally people are having some kind of complaint or some kind of problem that's leading to them undergoing cervical imaging either cervical MRI, CT, or some advanced imaging that's producing the radiographic diagnosis of central spinal stenosis.

And then the key becomes a thorough neurologic exam and assessment. And then, in my own population of patients, really following these people over time, I agree completely with Dr. Traynelis is saying that these patients with minimally symptomatic central spinal stenosis generally can be safely followed, but I would hesitate to try to set up an NCD or LCD what clinical findings warrant operative intervention in that subset of patients.

I have patients who may develop, C7 patterns of motor deficit and they won't even notice it. Because it's not, not that big a deal, for not being able to push away with your triceps, unless you're doing push-ups or physically active, or doing either demanding, demanding physical activities.

Where a C8 pattern where you start developing even mild weakness in your hand intrinsics for artists, for craftsmen, for people that are working with their hands or doing any kind of fine motor tasks. A mild pattern of deficits can be functionally very limiting.

So, even early, findings of myelopathy in this subset of patients in specific patients may be indications for intervention. And again, it's something where the heterogeneity of presentation of these patients, you're gonna make it difficult to mandate a coverage determination that will cover all of them, or you had to a certain degree, trust the patients, and allow the treating physicians to help guide the different treatment options that are available.

Dr. Eileen Moynihan:
Thank you. Are there any other comments?

Dr. Shivers:
Yes, this is Shivers again. I think that was really well said by both Dr. Traynelis and by Dr. Ratliff.

You know, I think a common theme of, of the, of the discussion today has been that for a lot of these situations, especially in terms of the surgical planning, there just isn't a one size fits all answer, and that there's a lot of heterogeneity and clinical judgement required. And I really agree with that, as a nonsurgeon. I agree that, you know, in terms of figuring out the best operative approach, that's something I, a question I, you know can, you know opine on, but certainly end up guilding to the surgeon.

I think this central spinal stenosis question is, is, is interesting and germane, and I agree, I think that trying to like, write in a bunch of guidelines around it, it has the potential to be cumbersome.

I also think that in terms of unscrupulous people kind of like slipping things in that this is, this is a big, sort of gray area in that regard insofar as some degree of central spinal stenosis is extremely common. And so, we've been talking about it as though it is you know frank, cord compression without symptoms, but radiologists will often call mild to moderate spinal stenosis just out of the sort of compulsive way you know, we're all supposed to comment on these things when we're, when we're looking at the radiology reports.

So, you can end up in a situation where somebody got the MRI because they have severe axial cervical pain. And you know, whoever was ordering the MRI was, you know, looking to rule out a tumor or just not necessarily following the guidelines in terms of imaging and certainly I will order MRIs on patients with intractable axial pain just to sort of clear the board in that regard.

But I think that there is some nuance to directing patients and kind of potentially having conversations with surgeons or reviewing the documentation to understand that the purpose of a potential surgery in that case is really to arrest or reverse neurologic decline and not as an excuse to do a multi-level fusion on somebody who has axial pain and otherwise based on their symptoms and signs wouldn't qualify for it for the fusion surgery. And I do that with the utmost respect to everybody on the call. Certainly, in terms of, in terms of all of the discussion and judgement here. But I do think that that is a case where I sometimes see people who are operated on for pain of the neck than there. You know, it's unfortunate, and I don't know that it's the job of Medicare to police that, but I think that it's, it's something to sort of be aware of, at least.

Dr. Eileen Moynihan:
Thank you, other comments?

Hearing none, I'll move on to the final category. Others, such as ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, malignancy, and tumors. Same question.

Dr. John Ratliff:
I guess this is more, John Ratliff at Stanford.

So, for a traumatic patient with you a DISH or ankylosing spondylitis. Those are patients that most commonly, are going to be routed towards stabilization or fusion procedures. Ankylosing spondylitis as a diagnosis in isolation, meaning a non-traumatic AS patient, they're fusing their spine already, not necessarily an indication for surgery, but when those patients will be presenting, that should only be a Medicare beneficiary who's been involved in a motor vehicle accident or a fall with a head strike. Who's going to have a fracture on top of their DISH, or on top of their ankles and spondylitis DISH meaning the diffuse idiopathic [inaudible] Going to be routed towards operative intervention.

Dr. Eileen Moynihan:
Excuse me, excuse me, Doctor. Could you please mute your line if you're not speaking? Please mute your line if you are not speaking. Go ahead Doctor, sorry.

Dr. John Ratliff:
Alright. And the final question was the one about malignancies and tumors.

For malignancies where there's structural deformation or structural destruction of a highly mobile spinal element, such as the cervical spine, generally that it is something where operative intervention is going to prove necessary. There are certainly cases like isolated plasmacytomas or multiple myeloma involving the spine where radiation may be functional and radiation may be all that you need. But it's quite common that we see patients with pathologic fractures and vertebral body involvement from neoplasms where surgical reconstruction is necessary.

For spinal cord tumors, for tumors intrinsic to the neural elements in the cervical spine, the risk of kyphosis or development of a worsening cervical alignment in surgical treatment of those patients is quite high. So, it's also quite common that in arthrodesis or a stabilization procedure being incorporated when patients are presenting with an intramedullary meaning inside their spinal cord, neoplasm, necessitating operative treatment. So, in each of these cases an arthrodesis or stabilization procedures relatively commonly used.

Dr. Vincent Traynelis:
Vince Traynelis from RUSH. I agree.

I think if you look at ankylosing spondylitis and DISH, those patients requiring cervical fusion are all going to be in the trauma category.

If these entities cause a deformity, usually the correction may be done more caudal the cervical thoracic junction or thoracic spine depending on where it is, it's less likely to be in the sub axial cervical spine. So, these are trauma patients that have highly unstable fractures and would require fusion.

Another subset of the tumor would be a large neurofibromas and Schwannomas. If removal of the tumor requires complete facet resection and that creates instability. So, although these are benign tumors and may not require radiation depending on the bony exposure, required to safely remove them, fusion could be indicated.

Dr. John Shivers:
Shivers from Pittsburgh again.

I would just nominate to, to, to solicit opinions from the, one or more of the surgeons on the call about the role of fusion surgery and infection as well as osteomyelitis of epidural abscess, those sorts of entities.

Dr. John Ratliff:
That's a great question. John Ratliff from Stanford, a set of patients, that we haven't covered.

The way the spine heals from a discitis is by fusion. So, if you have let's say a discitis develop in, your C5, C6 disk space, and generally that disk is going to be completely consumed by the infectious process and then you'll have this spine heal to be arthrodesis across the involves segment. So, your end result here is a fusion. But without cervical stabilization and without surgical treatment, you certainly worry about, epidural abscess. You worry about catastrophic neurologic compromise. You really worry about these patients deteriorating and perhaps, deteriorating in a very dramatic fashion.

So quite often, these patients are treated surgically. And your surgical strategy usually involves both debridement, the involved infected bone, treatment of the patient's osteomyelitis with debridement of the involved vertebral bodies, and then reconstruction of the spine either bone graft, or by use of titanium cages to restore structural alignment. And a lot of times in my hands, at least, those patients are treated with both the anterior and posterior approaches is because of the severity of the bony destruction and the severity of pathology in infection patients who end up needing surgical treatment.

Now, you can also have patients that you can treat successfully with antibiotics. And, purely medically, if you, in my clinical experience at least, pick up the infection very early in its course and begin an aggressive course of IV antibiotics before the patient goes ahead to develop a severe destruction of a disk, or, epidural abscess, or other evidence of worsening structural deformity of their spine.

Dr. Eileen Moynihan:
Any other comments? OK, I think that concludes our questions at this point.

So, we'd like to thank the CAC panel for this information, and the discussions, and for taking time out of your day to be here and share your expertise.

We'd like to thank all that those who are listening, and also the other CMDs.

The MAC CMDs will take the information from today's meeting and continue discussions on the topic.

Please monitor the MAC websites and listservs where the publishing of a proposed LCD for public comment will be communicated once it's done.

We thank you all again for your time today.

I would like to say that we do need to have articles that you referred to that were not on the list sent in.

And anyone who has written comments, please be sure to send them in. And other than that, have a wonderful day. Stay safe and you finished ahead of time in a project I never thought you would. Thanks again.

Dr. John Ratliff:
Not to belabor things, but who should we send the articles to or who's the point of contact for any citations that we discussed on the call?

Dr. Eileen Moynihan:
Kari did you say that in the beginning of where of where they send?

Jocelyn Fernandez:
Dr. Moynihan, this is Jocelyn. You can e-mail them to CACmeeting@noridian.com.

Dr. Eileen Moynihan:
Did you get that? Wanna repeat that one more time, Jocelyn.

Jocelyn Fernandez:
E-mail is CACmeeting@noridian.com. So, it's (spelled out) CACmeeting@noridian.com

Dr. Eileen Moynihan:
Thank you. Thanks everybody.