Minimally Invasive Arthrodesis of the Sacroiliac Joint (SIJ) Open Public Meeting - April 18, 2024 - JE Part B

Kari Dupreez:
All right, good afternoon, everyone. My name is Kari Dupreez, and I am one of the medical policy specialists here at Noridian Healthcare Solutions.

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

All lines are currently being muted and will remain muted throughout the meeting. Only those who registered to present will be allowed to comment on the proposed LCDs today.

For the presenters, you are being allotted 10 minutes to make comments. Your line will be opened when it is your turn to speak. Make sure you are not on mute within your system, or we will not be able to hear your comments. You should be prepared to begin your presentation immediately when called upon and will hear the moderator's voice when one-minute remains.

We have added a closed caption feature in real time for today's call. Please speak clearly to ensure that the system will be able to translate into captions for display.

As I have mentioned, the recording and transcript will be posted to our website. By signing in today, you are giving consent to the use of your recorded voice and your comments. Please be mindful of sharing any personal health information during your presentation.

In addition to comments that are made today, all comments should also be submitted in writing. All written comments received will be recorded in the response to comments article.

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

Dr. Eileen Moynihan:
Thank you, Kari.

Welcome everybody to our Open meeting on Minimally Invasive Arthrodesis for the Sacroiliac Joint.

We look forward to any evidence you can bring and for your comments regarding this proposed LCD, and we definitely appreciate the time that you have spent and put aside for this meeting.

I think we can move ahead with our first speaker, Karin Bolinger. Karin.

Karin Bolinger:
Hi, good afternoon. Thank you, Dr. Moynihan.

My name is Karin Bolinger. I'm a consultant within the medical device industry. I've worked in medical device for the last 28 years, primarily in health economics, research, medicine, and also in market access and health policy.

Next slide, please.

What we'd like to address here today is just a couple of items. One is looking at clarification on one of the required medical necessity requirements for the current and the proposed LCD, and then looking at proposed language on coverage on approach in transfixing versus non-transfixing devices.

Next slide, please.

And so what we were specifically looking for clarification on, and this has been something that has created confusion for many physicians in light of the ongoing ADR requests and audits, not just with Noridian, but elsewhere across the country. And that is specifically looking at number five that talks about clinical findings and imaging studies that don't suggest other diagnosis or obvious causes of lumbar sacral pain.

As we know here when we're looking at SI joint dysfunction, we can have pain that mimics each other from a lumbar involvement. And so when we see these patients, many times they've had prior lumbar surgery and upwards of 40% of the patients have had prior lumbar surgery, and so there might be things such as central canal stenosis, foraminal stenosis, disc herniation.

And so what the clarification that we're asking for is if you took the scenario of a patient, for example, that had a post-laminectomy or failed back syndrome of post-fusion and their pain is controlled within that region, whether it was due through a series of conservative management or injections looking at lumbar epidural steroids, medial blocks, PT, and medications, and the patient is now considered stable within their lumbar involvement. Is it appropriate to move forward now and treat their SI issues when we've confirmed that there are SI generator, pain generators here?

And so it's looking for clarification on that, because we do have, again, 40% of our patients that wind up with concomitant symptoms and/or have had prior lumbar treatment and may still be aggravating certain conditions, but we keep that stable.

So that's one thing that we're asking for, and we'll ask for in the written comments.

Next slide.

So looking at the proposed language, there's one thing that we've seen with Noridian and Palmetto that we would like to make note of clarification, and that's talking about what qualifies as a non-transfixing or non-transfixation approaches and/or dorsal posterior approaches and the dorsa-lateral approach.

In summation here, it states that anything that would be dorsal posterior or a dorsa-lateral approach cannot be transfixing, that they utilize distraction arthrodesis, and that's actually clinically not correct. And I'll talk a little bit to that today, but I think others are going to speak more eloquently on that topic and clinically how that applies.

But from the standpoint of looking at posterior approaches, these are some of the devices, these are not allografts, these are devices that have been approved as of recent, I would say, the last 18 months, through the 510(K) process that required ASTM standards for standalone posterior devices for transfixing, as delineated by the FDA or an equivalent testing.

And all these devices were shown to transfix in their approach, again, some of these being posterior, some of them being oblique, which is a lateral, what you're referring to here is a dorsa-lateral approach. And so to note, all of these devices have been deemed by the FDA and others that they clearly transfixed the joint.

And so that needs to be made note that it's not really about the approach, it's about the device itself, whether or not it actually penetrates through the bone and holds that motionless across the joint and through the two bones.

Next slide.

And I think where the confusion came into is looking at where distraction arthrodesis happened. Most of the allografts do utilize distraction arthrodesis.

There is one device that has two-year data out there. And this is important to note that just because they're not a transfixing device, that this is a distraction arthrodesis device, it still had a high level of fusion with this device. And this was a very well-designed study that was done in Germany and throughout Europe. I believe it- I'm going to say 20 centers, and I could be wrong about that. We'll submit that publication, but it's worth noting to look at that paper as well, because, just because the device isn't transfixing does not mean that you don't have fusion.

Next slide.

And I wanted to provide a little bit of editorial panel history here from the CPT meetings. I've been in this part of industry for the last five years. I've been at every single CPT meeting that was related to these devices for every type of configuration you can imagine.

And just for some understanding, this initially, this code of 27279, which is the transfixing code, was brought into inception in 2015. Prior to that, it was a category III code. The code has not been changed through these recent reviews through the CPT editorial panel. What was one modification was the definition of transfixing, but that did not change the code itself. None of the language changed. And so somewhere along the line, somebody introduced directionality into this code.

There's never been a directionality in regards to approach with the code. So, in other words, if you're transfixing the joint, it doesn't matter if you're coming in lateral, posterior lateral, oblique, medial to lateral is even a consideration that can be performed with some of these devices. And so, all of those would fall under 27279 as long as the procedure or the device actually transfixed the joint. And so, that's important to know, it's not about the approach.

27278 was split off after it had gone to CPT review. It went through a series of one whole year where CPT did not think that it was important enough, or relevant enough, to make a distinction between allograft or the types of intra-articular approaches on transfixing versus non-transfixing devices.

That did not come out 'til May of 2022 when, through pressure from some of the societies, a code was split off, and that is where we wound up with 0775T, which turned to immediately a Category I code of 27278 that was effective January 1, 2024 of this year.

So, subsequently, just to note that when the 0775T code was assigned, we had gone to OPPS to get assignment for outpatient hospital and ASC on that 0775T code, and CMS and CPT both recognized that machined allograft that was utilized to be put in specifically for an SI fusion. They determined that from a payment standpoint, the payment was looked at the same as a titanium device.

And thus, if when you look at the 27278 code, and it talks about allograft implants that, you know, are non-transfixing, that there was no distinction between a machined allograft and a titanium or synthetic metal is how CPT made that determination to say that there was not a distinction between the two.

Next slide.

And then just real briefly in the time that I have remaining, I did want to bring up a couple of issues about data, and specifically looking at one of the papers that was cited, and that was on the third citation on the POLI paper. I believe it's two-year outcomes from randomized controlled trials, minimally invasive SI joint fusion, non-surgical management for SI joint dysfunction.

There's a couple of important points to note here. Clearly, lateral has been the gold standard. I think as we've gone through the last 10 to 14 years, we've learned there's better and safer approaches. You know, that can be seen even throughout this paper.

The paper had very good pain score outcomes, as well as ODI outcomes, but it's worth mentioning, you know, the safety profile on laterals is not perfect by any means. You have vasculature, you have nerve bundles that you have to avoid, and with that, on this single paper, there was a 23% complication rate. And arguably, some of those complications were pretty significant in having vascular injury as well as nerve injury, long-standing nerve injury.

The other thing I wanted to point out about the data is, as we present data to Medicare, we're always supposed to be representative of the Medicare age patient population. This study specifically that was cited excluded any patient on disability, and what that resulted in is that we had an average mean age of 50.2 aged year-old in the treatment group. And when they broke that down further to look at what percent of the patient population was 65 years and older, only 9.8% of the patients that had a fusion are representative of a Medicare aged patient population.

And again, just being the health economist that I am, one of the things that was interesting to me is this is a minimally invasive approach as a lateral approach, but when you look at the hospital length of stay, we didn't really do much to decrease the hospital length of stay compared to an open procedure.

In this study specifically, we had 41% of the patients were discharged the same day, but greater than 55% of the patient populations actually stayed in the hospital one to two days. So with these newer approaches, the majority of them are done in the ambulatory surgery center, and upwards of 85% of them, patients are obviously discharged the same day. And again, that has to do with the safety profile of these new devices.

So I thank you all for letting me speak here today. I really want to compliment the organizers of the meeting. Having gone through this last week, I can say this was a much smoother process with Noridian, and I compliment you on having this so well organized in the communication.

Thank you.

Dr. Eileen Moynihan:
Thank you. I'll take that as a great comment for the folks that support me. I agree with you.

Dr. Donner, would you like to start?

Dr. Jeff Donner:
Yes. Can you hear me?

Dr. Eileen Moynihan:
I can.

Dr. Jeff Donner:
Good. Well, again, thank you; and thank you, Karin, for your presentation.

Some of it overlaps with my slide presentation, so I will not go into the detail and try to keep it mostly about patient care, and I just want to start off by giving some background which I think is important.

I was first diagnosed with SI joint pain and problems by the chief of orthopedics at Temple University Hospital, who was also the chief at Shriner's Hospital in Philadelphia 50 years ago, after a sports injury, and I was treated conservatively, and I still have symptoms but not bad enough to have surgical intervention, fortunately. But obviously this goes back 50 years of my history and as time evolved, I ended up in medical school at Temple University and also have my orthopedic training at Temple University Hospital. So very interesting how I got into this space, and so I had my eye open for even though I wasn't trained in SI joint treatment as an orthopedic or spine fellowship trained surgeon.

So with that, I looked for this problem and it evolved in time, and I want to emphasize that this is really a problem where the solution is in evolution, and what we don't want to do is be forced into certain, you know, areas where we have to treat patients that don't necessarily fit the problem they have. And they need to have the ability, meaning the surgeons and the patients, to adjust to their specific problems, whether it's their anatomy, their own density, their prior surgeries, their age, all those things have to be considered. So I'd like to make sure we understand where I'm coming from. Also, since that time, I have been treating surgical - I've been treating SI joint pain surgically when they fail to serve treatment, and I've done several hundred of these procedures over the past 30 years.

With that, I became more involved in research and working with other groups that have similar interests, one of which is the Sacroiliac Medical Expert Group that was originated in Germany with some European surgeons from a variety of countries, and I was invited to join them over time, and we've had many international meetings. And I've also been president of that society for about two years, and now I am vice president. And I only mention this is that a lot of what we are learning in the United States, at least, is through industry. But there are other societies out there, the one I'm speaking to specifically, that are addressing it from a broader sense. Like, we're not - we may have some conflicts, which I do as well, but we want to make sure that we represent all the other possibilities on how to treat SI joint pain in our patients.

So, when I first started doing this surgery, I did it through the Smith-Peterson lateral approach. I didn't like that, it wasn't working. I went to an anterior approach to revise it, and in my opinion that was even more challenging and got into a bleed that was - basically gave me the energy to find a better way to do it after you see that bleed in the pelvis.

So then I went to the dorsal posterior approach, and I found that that was very effective and safe. And that was more of an open approach at that time, using orthopedic principles to remove the tissue, including the degenerative papal cartilage, and then performing a fusion with fixation using the transiliosacral technique. I found that very effective, and over the years, when it became more accepted, we reduced this to less invasive procedures through the posterior inferior approach, with and without fixation.

So, with that background, I just want to make sure that the panel recognizes that the surgeon needs to have the ability to treat the patient that's in front of them, depending on many factors that aren't always understood by people who are not of the experience that I am, and several others who have been doing this for many years.

And with that, I do need to make some disclosures. I am the president of a company called SI Technology, where we have several devices in the process of being cleared by the FDA, and these have gone through rigorous finite element modeling testing, cadaveric testing, which, you know, is way more involved than when you're trying to get an allograft cleared to be used in the patients that you've seen.

And with that, I do want to make sure that I'm not opposed to allograft, and I'm not opposed whether you have fixation or non-fixation. We just want to make sure the patient ends up with a safe, effective, and durable outcome.

With that, we have to recognize these anatomic variants and have the ability to move to whatever device, whether it's fixation with the iliosacral or sacroiliac direction or within the joint itself. So that's what I'll summarize at the end of this presentation.

May I have the next slide, please?

So again, without getting into all the history, we know that the SI joint can be a pain generator. We know that the lumbosacral spine has a lot of potential sources of pain that could make you think your SI joint is in pain and make the provider think it is and actually over-treat the SI joint. So we want to make sure that we always work up the lumbar spine, but realize that patients can have both. And you have to do a good workup, but not ignore the fact that not everything is pure lumbar and not everything is pure SI joint. And the patient should be able to have both treated individually, just like you would treat a left knee and a right knee and not say the patient is not a candidate because they have both.

Next slide.

There are a lot of ways to work up the pain generators, and I won't go into that, but again, there's a lot of biomechanical variation in patients' SI joints, and we know it doesn't move very much, and that's a kind of a stumbling block for some people in that it doesn't have to move to be in pain. A very small amount of movement can make a joint hurt, especially if you have a lumbar fusion that adds extra stress to those areas. So we want to be able to pivot depending on that problem.

So one of the things to look into is the Sacroiliac Medical Expert Group has a website, and on there we have a variety of presentations that we have given, and these can be researched as you can see here on the bottom of the screen. So I encourage people to look at that for some more information on the biomechanics and other related topics related to the SI joint treatment.

Next slide.

Again, which direction you go. I do believe the laterals have viability, but they also do not really create a true fusion almost all the cases. Not that they can't, but that's not what's actually happening the majority of the time.

They do also have a high incidence of neurologic and vascular injuries, and the Mod Data Bank will pull, if you pull that up, you'll be able to see that there's quite a bit of complications. And that's, as we know, it's not reported to the percentage of patients that actually have it, but only maybe 10% or less actually reported.

So I think we need to keep looking for a better solution. And I do believe the dorsal posterior approach or like-approach can provide that for our patients. And we want to have our patients safe. That's the number one thing that we want, and then obviously effective and durable would follow that.

So how we do that depends on a lot of factors and the way these devices are developed, how they're actually placed, and what type of underlying pathology the patient has. So again, these are the references at the bottom that you can use for this.

Next slide.

These are examples of dorsal approach where you can see there is transfixation, that you can provide this by designing the device, such on the left side you can see the X device that we are actually developing, but not cleared yet, as well as a Catamaran device on the right side that crosses the joint in a similar fashion, just a different design. So, these are posterior transfixating devices that we have to prove with not only FDA, but also cadaveric biomechanical studies.

Next slide.

So when we select these devices, we just can't mix and match everything. They really should be, by FDA criteria, a complete system. So you can't just put an allograft in and then put a screw across and say that you're providing that type of a hybrid type of system. They have to be fully tested to be sure that they are doing what we say they're gonna do. But we need to the belt and suspenders a lot of time. In other words, we need a dorsal approach and supplement it with a transfixation device within the dorsal approach or even separately through a separate incision and transiliosacral or sacroiliac.

Next slide.

This is an example of the kind of patients we're faced with, and this is my patient that had a prior L4 to S1 [inaudible] fusion, very solid in the woman in advanced age, and she had a successful lumbar surgery but developed SI pain. She was treated on the left side with these iFuse rods, and because of the long fusion and her bone quality, they had loosening.

So we were able to salvage this through a minimally invasive posterior inferior approach, as you can see on the picture that has the L, it's at the left side, but it's on the right side of your screen, and those little dots are the metallic markers within peak, which is a translucent device and bone grafting. You can see on the left screen, where it looks like under CT, there's a halo around that rod at the very bottom of the screen on your right-hand side, and we were able to get a bone fusion underneath it and save this patient a very complicated anterior or revision lateral surgery. So we want to have that tool in our toolbox.

Even in some cases you need more rigid fixation, and you can obtain that, as you can see by placing pedicle screw in S1 and in the ilium and doing a direct posterior fusion, and look at the solid arthrodesis you can see on the left side. So that's another unique type of approach, and we can use, and we have to be able to have that in our toolbox as well.

Next one.

Again I want to emphasize, it's not so much the approach, it's what you're trying to achieve. And we want to have that ability to get fixation, stability, and fusion.

I do have a problem with just allograft alone that's not placed in the right place, it's not prepared, the joint is not prepared adequately, and some of these studies that are being presented don't show that the device is actually in the joint, nor do they show it's fusing. So, I get to wonder why we aren't requiring a higher level of cadaveric testing and x-ray CT to make sure that they're achieving what we need them to achieve for our patient's long-term benefit.

Next slide.

So, with that, I'd like to conclude that's not one size fits all. We have to have the ability to adjust as surgeons. We don't want the coding to be an issue or the reimbursement, we need to figure out a way to make sure our patients get what they need and not get hung up by some of the semantics and details of transfixation versus non-transfixation, as we've mentioned and Karin has also outlined.

So with that, I thank you for the time, and I'm available if you have questions. And I, again, suggest that the Sacroiliac Medical Expert Group and their website is a good source, and I hope others will join us.

Dr. Eileen Moynihan:
Well, thank you very much, and thank you for your clinical insights.

I will comment that I went to Temple but went the rheumatologic route. So I must ask, why are people not trying to keep the joint from fusing like I am?

I'm just teasing. That's what -

Dr. Jeff Donner:
That's right, so you're trying to prevent it from fusing with ankylosing spondylitis, I got it.

Dr. Eileen Moynihan:
Yeah. Anyway thanks. Thank you very much and be sure we have your comments in writing as well.

Dr. Kalia, do you want to begin?

Dr. Hemant Kalia:
Yes, good afternoon everyone. Can you guys hear me?

Dr. Eileen Moynihan:
Yes.

Dr. Hemant Kalia:
Perfect. So thank you so much for giving me the opportunity to present.

I really appreciate this, and I'm currently presenting more than 4,000 physicians who are part of American Society of Pain and Neuroscience across all disciplines ranging from neurosurgery, orthopedic spine surgery, interventional pain medicine, physiatry, anesthesiology, and interventional radiology. I'm the current chair of the Advocacy and Policy Committee.

And over the next 10, 15 minutes, my goal would be to present some of the data, and also hopefully make a case for asserting the facts and convincing the esteemed group of the Medical Directors here of Noridian group to change their proposed language on the LCD where they have deemed, or proposed, the minimally invasive sacroiliac joint arthrodesis through a non-transfixation device, experimental and investigational, primarily focusing on the 27278 CPT code.

Next slide, please.

These are some of my disclosures, nothing pertaining to the presentation today.

Next slide.

So before we move on, I think it's important to kind of understand the overall burden of this disease. I know the previous presenter kind of gave a really nice overview, but it behooves us to kind of understand what we are dealing with. You know, all the chronic low back pain patients, there is about 30% probability, so in simple words, one out of those three patients will have SI joint as their pain generator. So we're dealing with a very specific pain generator which leads to chronic low back pain, which has been the source of most commonly presented chronic pain presentation in the United States. And it has a huge burden on the society, both in terms of the costs of health economics and also the disability.

Next slide.

When it comes to sacroiliac joint dysfunction management, a majority of these patients would benefit from a good comprehensive interdisciplinary model of care. They would benefit from a good structured physical therapy program, some exercises, and conservative treatment options, which can range from few injection therapies to some other comprehensive approaches. But there will be a small subset of patients who will stop responding to these conservative treatment options, and that's where the role of these minimally invasive approach to fuse that SI joint is gonna come into play.

Historically, we used to do these surgeries open with huge morbidity associated with them, but over the years, now we have more minimally invasive approaches available to us where we can achieve the same results with almost negligible or least morbidity.

Next slide.

About one and a half years ago, one of the treatment options, despite being really effective, which is known as radiofrequency ablation of the nerves, which carry the pain signal from the SI joint, this specific therapy was deemed experimental and investigational by the regional MACs. Now what has happened over the years is that because the lack of access to this evidence-based therapy, patients will be moving towards an approach to fuse the SI joint. And that's exactly why it's important for Medicare beneficiaries to have access to all options for fusing the SI joint, not only the open approach and the lateral approach, which is very nicely covered in the current proposed LCD, but also the posterior or posterior lateral approach to minimally fuse the SI joint without a transfixation device.

Next slide.

So, when we talk about, you know, SI joint pathologies, it's really important to kind of make a diagnosis first, and I really commend the wiseness and also the earnest efforts of the Medical Directors of Noridian who came together and put this nice algorithm to identify the patients who would justify the medical necessity for this approach. So as you can see, you know, we have the diagnostic imaging modalities, we also have the clinical tests, and also the importance of the response to diagnostic interventional blocks. So I think it's really important to have all these three factors to identify a true patient who would benefit from minimally invasive sacroiliac joint fusion.

Next slide.

So when it comes to minimally invasive fusion, I think, again, credit has to be given to the Medical Directors to include both the approaches, which is using a transfixation device and the other approach, which is posterior or posterior lateral, of not using a transfixation device included in the proposed LCD. Hopefully, in the next five minutes, we'll be able to present the recent literature and also some of the associated things, and help convince our Medical Directors of Noridian to change their stand on the minimally invasive approach for SI joint arthrodesis, not utilizing the transfixation device.

Next slide.

So these are some of the studies which have been published in the posterior approach for SI joint fusion, and you can see there are a slew of case series, case reports. We have retrospective studies. We also have the biomechanical studies of a specific allograft link system, comparing it to the standard of care, which is the gold standard, which is the lateral approach where most of the biomechanical literature is available, and most recently published a 12-month data on a prospective study for posterior approach to fuse SI joint.

Next slide.

This nicely summarizes the biomechanical studies done by Dr. Sayed and his group. They initially looked at the strength of the fusion which happens across the joint using a specific link allograft, and then they decided to compare their results with the industry standard, which is lateral approach, to fuse the joint in a trans-articular fixation and they compared the strength and the efficacy of that fusion, which is obtained through this second study, which you can see in the bottom part of the slide.

Next slide.

This slide nicely summarizes the importance of the posterior approach to even salvage some of these patients. As mentioned in the presentation of the first presenter, that these patients can have overlapping symptoms with other pain generators, and these patients can have other advanced neurostimulator devices or other interspinous spacer devices used to manage other pain presentations. So this study nicely summarizes the importance of using the posterior minimally invasive approach to even salvage these patients.

Next slide.

I want to quickly go into the most recently published prospective study. This was a single-arm, multi-center prospective study which was done to evaluate the efficacy and the safety of this novel posterior approach to fuse SI joint. And they followed these patients for 12 months, which is the first in the field of posterior approach to fuse SI joint. Obviously, the primary outcome was based on the pain improvement, the VAS scores, but they also had the secondary outcomes looking at the ODI scores.

Next slide.

And I really like this specific slide. You know, this is - the tornado graphs are really near and dear to my heart, because it gives you a snapshot of every single patient who actually participated in this study. And as you can see very clearly in these tornado graphs, you know, more than 70% of the patients continued to report significant improvement in their overall pain by the end of 12 months. In fact, about 30% of the patients had a mean improvement from their baseline, which was statistically significant, and it persisted right from three months to all the way to 12 months, which is really impressive.

Another, from a safety standpoint, the researchers also concluded and reported that there was no implant related, serious adverse event noted in this specific study. So which is, which again goes back to the comments mentioned by some of the other presenters so far, that this specific approach is not only effective but safe as compared to the industry standard to fuse the SI joint.

Next slide.

In addition to pain, I think we also want to focus on the functional improvement of our therapies, and this slide nicely summarizes the statistical significance of functional improvement with this specific novel approach to fuse SI joint. You can see by the end of 12 months, about 21% of the patients continue to report significant improvement in their functional scales through the ODI scores.

Next slide.

Finally, I want to quickly jump on to some of the best practice guidelines. I can proudly state here that our current best practice guidelines on the SI joint have been accepted for publication. There's a very strict methodology which we use to come up with these best practice guidelines.

Next slide.

And based on the current studies which we reviewed, our first recommendation from ASPN is that minimally invasive posterior SI joint stabilization with allograft is considered medically necessary when appropriate clinical criterias have been met.

Next slide.

Our second recommendation is the use of implants composed of human cells and tissue products for SI joint fusion is considered medically necessary only if the set forth criterias by the FDA have been followed rigorously.

Next slide.

And finally, you know, last time I checked, there are about 32 products available to us to fuse SI joint from different approaches. I think from an ASPN standpoint, we support the utilization of sacroiliac joint fusion and stabilization devices, provided these devices have published their efficacy and safety data through a prospective multi-center study for at least six months.

Next slide.

So finally, to conclude, I do want to also comment on the health economic aspect of the both 27278 code and 27279 code. You know, 27278 is the only code which has the site of service differential for office-based procedure. And if this specific code is deemed experimental and investigational, we will be moving or pushing Medicare beneficiaries to a code or a procedure which will increase the overall cost of delivery of care in our community.

Next slide.

So to summarize, I think posterior fusion implants are safe and effective, which have been proven through multiple studies. It has comparative efficacy to the benchmark lateral approach of all fusion devices. It's a very safe approach to fuse SI joint with least traumatic procedure, which supports the smoother post-op recovery for Medicare beneficiaries.

Next slide.

So, finally, our recommendation would be to potentially delete the statement from the proposed LCD of minimally invasive arthrodesis of the SI joint without placement of a transfixation device is not considered medically reasonable and necessary, or we would suggest considering an amendment to the proposed language to retain access for the safe, equally effective, and opioid sparing treatment options by focusing on meeting the medical necessity criteria as established and delineated by the Medical Directors in the proposed LCD.

Finally, consideration can also be given to introducing prior-authorization process for both 27278 and 27279 CPT codes to a certain utilization management.

Next slide.

So, with that, I would like to finish my presentation here and happy to take any questions at this point, or we will also submit all our comments through a written opinion letter.

Thank you.

Dr. Eileen Moynihan:
Dr. Kalia, do you have any guess or idea when your guidelines might be published?

Dr. Hemant Kalia:
The guidelines have been accepted, so hopefully it's an open access journal, so hopefully we should have something come out in the next two to four weeks' time frame. I can certainly reach out to the editor in chief of the journal and report back to you guys.

Dr. Eileen Moynihan:
Yes, thank you.

I'm not- I think there are other contractors who have to go through the Open Meeting process, so I'm not sure what the time frame of those are, so it may work out just fine. Just when you do get it, I'm sure we would all be interested in knowing that it's out there.

Dr. Hemant Kalia:
Absolutely. Thank you.

Dr. Eileen Moynihan:
Okay, thanks very much and thanks for your presentation.

Dr. Sanapati.

Dr. Mahendra Sanapati:
Yes. Next slide, please.

I'm the current President-Elect of the American Society of Interventional Pain Physicians. Most of you might know this represents about more than 4,000 physicians from multiple specialties, including neurosurgeons, orthopedic surgeons, interventional radiologists, physiotherapists, and anesthesiologists, and a lot of other physicians doing pain management procedures. And historically, ASIPP has been very strong in advocacy and instrumental in establishing several guidelines for interventional pain procedures and also non-interventional pain management options, and ASIPP is also very strong with the CAC committee presences in all the states. And also ASIPP has separate state chapters individually all over the country.

So completing that, I would take this opportunity to thank you very much on behalf of ASIPP for allowing us to express our concerns regarding the current proposed LCDs from Noridian, especially DL39810 and 39812.

The main issues concerning in the current proposed LCD are a statement on behalf of NASS, that's North American Spine Society included in the evidence analysis. And also, the second point is a summation that all intra-articular allograft implants are not transfixing devices. And the third issue is a review of data not addressed in your literature research. And the fourth point is clarification regarding statement of non-coverage LCDs mentioned in the Noridian analysis of evidence. And the fifth one is a statement by CPT for procedural description.

So CPT committee has basically decided on this new code 27278, which is now category I code, which is intra-articular non-transfixing. So basically, these codes are determined by whether they are transfixing or non-transfixing. They are non-directional.

Next slide, please.

Coming to the analysis of evidence, and especially from NASS was included in that, according to NASS, there's a statement that there's moderate quality evidence that minimally invasive arthrodesis with placement of transfixation device for SI joint fusion is an acceptable option for patients with chronic SI joint dysfunction due to degenerative sacroiliitis and SI joint disruptions unresponsive to non-surgical treatments. And NASS agrees that these are consistently associated with improved pain and disability from baseline without substantial safety concerns, and this benefit is sustained in the long-term. But there's a statement which says, because diagnostic techniques for SI joint dysfunction can be unreliable, this may be a potential confounding factor in analysis of treatment protocols.

So basically, NASS reports there is insufficient evidence to make a recommendation for or against SI joint fusion compared with medical treatment for the treatment of low back pain due to SI joint dysfunction. But this was stated as opinion of NASS, but there were no citations or context of where this statement originated.

But if we look at the NASS coverage policy recommendations from September '21, published in September 2021, NASS says, this coverage recommendation is limited to the insertion of usually more than one structural device traversing the SI joint intended to fuse to the bone or lead to the fusion of the joint itself. So the coverage recommendation for NASS is coverage for minimally invasive SI joint fusions when all the criteria established by them have been met. Minimally invasive SI joint fusions have been shown to be relatively safe, with a minimal estimated blood loss, low infection rate, low complication rate, and low revision surgery rates. So much of the literature is subjected to potential bias since there is a high rate of industry-sponsored data. However, multiple SIJ fusion devices have shown similar results when we are talking about either posterior, the distractor arthrodesis, or lateral, or oblique lateral approach transfixing devices. The clinical efficacy for SIJ fusion in appropriately selected patients has been shown to be more effective than non-operative care and more cost effective.

Next slide, please.

We are moving on to the second issue, talking about distraction arthrodesis of an intra-articular approach, as stated in the proposed LCD, is not typical of all mechanisms of action and varies by manufacturer. So, it's portrayed in the proposed LCD as if the posterior approach arthrodesis is not transfixing, and if you look at the table here, the devices on the left, they are more consistent with the distraction arthrodesis. And the devices and the manufacturers on the right, they also allow transfixation along with distraction arthrodesis. And on the right, you can also include the Rialto from Medtronic.

Next slide, please.

And there are several studies here. They were not represented on the proposed LCD. But if you look at the devices, and these are studies including particularly these devices, the first column shows the devices, especially Omnia intra-articular allograft and Aurora SiLO intra-articular allograft, and then the next three are from Foundation Solution, CornerLoc intra-articular dual locking allograft, and the last one is NADIA/DIANA posterior distraction approach.

And if you look at the study design in the second column, there are multiple centers involved in these studies with very strong data, anywhere from one center to 20 hospitals were included in the studies, each study, and they were published in very strong peer review publishing journals. And if you look at the number of subjects in the fourth column, they have included anywhere from 10 subjects to 171 patients in these studies. That is pretty strong. And the duration of the study and outcomes data spans from anywhere from six months to 24 months, so we have two-year data. And if you look at the improvement in the pain in sixth column, there's significant improvement in the VAS scores, anywhere from 44% to 79.2%.

And if you look at the functional improvement, they're looking at several parameters. Pain tolerated walking, pain tolerated standing time, and also improvements in ODI and activities of daily living, and patients' global impression change, and also opioid sparing effects. And finally, satisfaction surveys were done and there was significant improvement up to 73%. And also social functioning parameters are looked at, and there is significant improvement in all these parameters. And looking at the last column, if you're looking at side effects, there were no serious adverse events noted in these studies.

Let's go to the next page, please.

So coming to the issue of this rationale for non-coverage LCDs. So according to the current proposed LCD, there is a statement which says a query of other paired LCDs reveals that for those that have an LCD on minimally invasive surgery of SI joint minimally invasive posterior dorsa-lat approach to access the SI joint, including use of implants other than those which are placed across the SI joint that's transfixing to promote fusion is considered experimental investigation, or unproven. Basically, this is excluding anything that is considered non-transfixing. But when we looked at some of the current MAC LCDs and policies for WPS, CGS, NGS especially, there is no negative coverage policy for minimally invasive surgery of SI joint regardless of the approach, either transfixing or non-transfixing.

If Noridian is referencing CIGNA, BCBS of Massachusetts, UnitedHealthcare, and BCBS of Louisiana, Coverage Guidance and Policies as an LCD, we have concerns based on criteria for a MAC utilizing the same investigational experimental criteria as a for-profit insurance company and how that would follow Title 18 of the Social Security Act. And many commercial for-profit payers utilize cost-effectiveness as a criteria for decision-making, which would not follow CMS guidelines for coverage decision making. So this is one of our concerns.

Next slide, please. Next slide, please.

Again, a reliance on commercial payers is a criteria, as stated, for establishing the proposed LCD requirements. And there are some plans here that cover SIJ fusion, regardless of approach and include coverage for both transfixing and non-transfixing devices. If you look at policies and guidelines from BCBS of Alabama, they cover 27278 and 27279, all approaches of transfixing and non-transfixing devices without any differentiation.

Next slide, please.

So, in summary, summarizing everything we have discussed so far, we have brought up some additional evidence and present it to you, and also we will deliver the written formal comments before the final decision.

And also we want to make sure that not all posterior implants are considered distraction arthrodesis and some posterior devices are actually, they can be transfixing. And the CPT deemed these two codes as non-directional. So, the difference in the codes is only transfixing and non-transfixing. And also, CPT concluded that both codes were sufficient in evidence for a Category I CPT code. And the North American Spine Society has not excluded non-transfixing devices from their coverage policy recommendations, so their statement should not be misconstrued.

So given the summary of evidence and the review of the mechanisms of action and approach, we request you to consider removing the non-coverage of posterior intra-articular lateral dorsal implants as stated, including that of allograft and synthetic materials, slash metals, transfixing and non-transfixing devices.

Next slide, please.

This concludes my presentation and thank you again for giving us this opportunity to express our comments and concerns. And I'll be happy to answer anybody's questions, and we'll also be submitting written formal comments.

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

Dr. Naidu?

Dr. Ramana Naidu:
Thank you so much, Dr. Moynihan. We're getting to know each other very well over the last several months and thank you to Jocelyn.

Dr. Eileen Moynihan:
I don't think I'd let that get out if I were you.

Dr. Ramana Naidu:
What was that? I'm sorry.

Dr. Eileen Moynihan:
I said, I don't think I'd let that get out if I were you.

Dr. Ramana Naidu:
No, no, just we've been talking about a lot of different things, so I apologize. So thank you for the opportunity to comment on the LCD, particularly, like, joint fusion.

Next slide. Whoops.

Krista Babbitt:
We don't have a presentation for you.

Dr. Ramana Naidu:
I sent it in to Jocelyn, and she said she would put it up yesterday.

Dr. Eileen Moynihan:
Do you folks want to look to see if you have anything and let him know whether you have anything, and we can let Dr. Foster speak while we do that? Would that be okay or do you have an appointment?

Dr. Naidu?

Dr. Ramana Naidu:
Yeah, I'd prefer to do it with the presentation, so why don't we go ahead and let Dr. Foster go. Thank you.

Dr. Eileen Moynihan:
You just want to go?

Dr. Ramana Naidu:
No, no, I prefer to do it with the presentation, so we can let Dr. Foster go ahead. Thank you.

Dr. Eileen Moynihan:
Okay. Let us look, and you know this had to happen because our first speaker commended us for being organized. So something had to happen, right?

All right, Dr. Foster - I mean, Mr. Foster, will you please proceed? Thank you.

Steven Foster:
I will, thank you very much and good day to everyone. Thank you to Noridian and the panel here for the opportunity to speak. I'm Steven Foster. I'm CEO and president of Tenon Medical and decidedly not a doctor, so I want to make that very, very clear.

The purpose of the presentation is to focus on classification questions specific to the SI joint and the various technologies there.

If we go to the next slide, please.

We'll focus just on some granularity here as we go through this to make sure there's clear understanding. I think, as the previous speakers have made it very clear, that posterior or inferior posterior approaches can clearly transfix the joint. Simply wanted to give an example of those and provide some granularity on the issue.

Next slide, please.

The proposed LCD has directional implications that should be clarified. While many intra-articular devices utilize posterior or dorsal approaches of the anatomy, several others utilize posterior and or inferior posterior approaches to transfix the joint, as determined by FDA testing and 510(K) clearance.

Codes 27278 and 27279 are non-directional and defined only by whether the device transfixes or not. The term transfix was introduced and defined as part of the 2022 CPT May editorial meeting, which I believe has already been referenced.

Next slide, please.

Looking at these codes, the only distinction between 27278 and 27279 is whether a transfixing device is placed or not. All other components of the procedural descriptions are the same.

We could do the next click, please.

27278 is new in 2024 as a Category I code, as we've all heard previously.

Next slide.

These terms, transfix and intra-articular, are very different, with transfixed referring to piercing, spanning, or holding motionless, while intraarticular refers to being within the joint.

Next click, please.

It's critical to understand that AMA has discussed this on several occasions and confirmed that transfixed is not a directional guide, nor is direction contained within procedural descriptions or clinical vignette for these codes. I think that's a very, very important point here.

Next slide, please.

So quickly, examples of intra-articular devices are shown here. These are technologies that are placed such that the vast majority of the implant volume is placed within the joint for the purposes primarily of distraction.

Next click, please.

These are clearly not transfixing in nature. By contrast, we look at an example of an inferior posterior technology. In this example, a full 90% of the implant is anchored in sacral or ileum bone, with a small 10% bridging in between the two anchoring components. This format, with the vast majority of the implant placed in bone outside the joint, combined with defect creation, joint prep, and grafting, meets any reasonable definition of "transfix" for the purposes of arthrodesis.

Next slide.

Of course, perhaps more important, with the established principles of arthrodesis followed throughout the procedure, this transfixing technology produces a radiographic proof of bridging bone fusion, which reinforces the transfixing nature of the technology. You'll note the various slices from the distal tip of the implant through the proximal components from a post-op CT at 12 months via an interim analysis from our ongoing study.

And with that, I'd like to thank again, and I'll echo what Ms. Bolinger said in the beginning. The administration of this has been very nice, very efficient. The communication is great, and I'm very appreciative of that.

Thank you for the chance to speak.

Dr. Eileen Moynihan:
Thank you for your points.

I think our team has it together, and so we hope we have restored ourselves to the very excellent level that you pointed out in the beginning by being able to pull this up.

Steven Foster:
Yes ma'am, thank you.

Dr. Eileen Moynihan:
Are we gonna- thank you very much.

Are we going to the presenter seven now, folks, and then back to the slides that we just pulled up?

Kari Dupreez:
Correct. Yep.

But we'll go ahead with Dr. Pico, and then we'll go back to Dr. Naidu.

Dr. Eileen Moynihan:

Go back to Dr. Pico?

Kari Dupreez:

Yep.

Dr. Eileen Moynihan:
Okay. All right. I wasn't sure how you were going to do that. All right. Thank you.

Dr. Pico, would you like to?

Dr. Tristan Pico:
Yes. Thank you very much for giving me the opportunity to present to everyone here.

I am the secretary of the Arizona Chapter of the American Society of Interventional Pain Physicians, and everyone so far has done such an excellent job of summarizing data and other things that our main reason for being here today is to support what the National Society has said, and also to try to give maybe just a little bit more granular view of how this will affect the average pain physician and the patients that he or she serves. The Arizona Chapter has roughly 90 members, all of whom are in strong support of not proceeding with the 27278 code as it currently stands.

When I started my practice back in 2010, it was in the middle of the opioid epidemic, and the physicians that I worked with were strongly trying to turn the tide to more conservative care and interventional therapies in an effort to provide better pain control more safely and with longer durability. The kind of devices that would be controlled by the LCD are the kinds of devices that provide this very type of pain control. And so the Arizona Chapter is concerned that these, if the LCD stands as is currently written, that we will have patients who will not have access to adequate long-term pain control and from SI joint be due to the pain, and the concern would be that they would possibly be put back on higher doses of opioids.

In my clinic with seven physicians, we performed approximately 64 posterior approach, almost all using the link device. And of those, only three patients haven't achieved over 50% benefit. All the rest have, and all of our patients have been able to either be reduced or have reduced or eliminated doses of opioids. So I appreciate you hearing us out, and that's all I have to say.

Dr. Eileen Moynihan:
Thank you very much for those points.

Are we ready for the next one? Do you have it, folks?

Krista Babbitt:
Just a quick second, and I will get that going.

Dr. Eileen Moynihan:
I'm very glad we're not depending on me doing it. Okay, here we go.

Dr. Ramana Naidu:
All right. Well, thanks again, everybody.

My name is Ramana Naidu. I'm an anesthesiologist pain physician in the San Francisco Bay area. I'm the Medical Director of Pain Management at Marin Health Medical Center, which is affiliated with UCSF Health, and I'm the Medical Director of an ambulatory surgery center.

I'm the past President of the Pacific Spine and Pain Society. The Pacific Spine and Pain Society is truly a multidisciplinary society that does bridge together spine surgeons from neurosurgery and orthopedic spine surgery with interventional pain physicians from an anesthesia, PMNR, neurology, internal medicine or ER background, and inclusive of interventional radiology.

And the spectrum of care as you see at the bottom of the slide, I think everybody who's on this call has really seen that throughout the presentation so far today, starting with really conservative care with over-the-counter medications, going all the way to open lateral transfixation of the SI joints. And really this continuum of care is really important, because a number of the speakers on this call may do one, or two, or three, or four of these things. I have the advantage of being involved with all of them. So, I'm not speaking on behalf of one specific therapy, but as one who does all of these therapies.

And my key point today is that we are running out of access to options for our patients. And especially in the geriatric Medicare population, it's really important that we maintain options for the appropriate therapy for the appropriate patient.

Next slide.

Now, as past president of Pacific Spine and Pain Society, one of the things we did was once we heard about the LCD draft proposal, we sent a survey to our membership. We wanted to know about whether our membership was actually doing SI fusion, and if they've had any issues with specifically difficulty with denials or delays in reimbursement from Noridian. This is not meant to be a dagger specifically towards Noridian, but simply that PSPS encompasses the entire west coast of the United States, which of course is the same general jurisdiction of Noridian, and so we just wanted to hear from them what the responses were like.

So out of the 70 respondents, 51 said that they actually performed the procedure. 37 out of 51, 73% of those performing SI fusion stated yes, we had difficulty with Noridian as far as coverage and reimbursements. 9% stated they were unsure, and 18% said no, there were no issues. So again, this is not meant to be, you know, hypercritical or anything like that. It's just to inform you of some of the challenges we as physicians have had with this particular procedure within the Noridian MAC.

Next slide.

Now, all of my colleagues so far have really done a great job going into the epidemiology, the patient selection, the coding, which has become much more straightforward after the AMA RUC here, and then the cost-effectiveness, which we certainly have proven with the lateral approach and certainly will see with the posterior non-transfixating approach over time, I am sure. Dr. Kalia did a wonderful job with evidence, and you've seen the recent prospect of data, the 12-month outcomes with the posterior allograft approach, and all of that is great. However, what I want to focus on for my few minutes are the Medicare Administrative Contractor decisions on sacroiliac dysfunction therapies just in the last couple years.

Next slide.

So going back to that entire spectrum of care, and Dr. Kalia actually mentioned this himself, is that a year and a half ago - next slide, or next animation, if you will - a year and a half ago, we lost the ability to do lateral branch radiofrequency ablation, despite actually having very good evidence for its use specific to cooled radiofrequency ablation.

And now - you can hit next slide - we're at risk for losing post-year sacroiliac joint fusion, or stabilization that's non-transfixating based on the proposed LCD, and that could be a potentially huge risk to our patient population.

So at this point, if you have a patient goes to the usual conservative care, they have an injection, my only option at that point, if their improvement is transient, is to go on to putting in two or three screws across their SI joint. And while that's a very effective evidence-proven therapy for a number of our patients, as already alluded to, the complications related to that procedure is such that, do I really want to do that for an 86-year-old woman who has osteopenia going on to osteoporosis. Or what about the patient who underwent an L4 through S1 fusion, he's 52 years old, and basically when you bring up the idea of adding two or three screws to the SI joint, he says, no way, I don't want another fusion, that recovery was brutal for me, I want another option.

So I think, you know, the major loss is access to different options for our patients, and it could be more important than the geriatric Noridian population in having the ability to do these other therapies.

Next slide.

If we look at this entire spectrum of care, the evidence is very clear. We have now very effective therapies, and as we become more invasive, yes, the complication risk does increase.

Lateral branch radiofrequency ablation was very effective in my practice. I had 92-year-old women who really had no other option other than to have lateral branch radiofrequency ablation because of their osteoporosis. They couldn't have steroid injections because of the osteoporosis, and they certainly couldn't have screws across their SI joints. So what was their choice? Radiofrequency ablation.

Well, today, because no MAC covers it, those women are frankly just undergoing conservative care and dealing with it, which is not ideal for their quality of life. What I would hate to have happen is the exact same thing for posterior SI fusion.

Dr. Pico just mentioned his great success. I, too, have had great success with this procedure.

You have Dr. Calodney's prospective one-year data now just published in March of 2024 in JPR.

Yes, we're a little bit behind the lateral fusion approaches as far as evidence development, but it's going to happen. It would be a huge detriment to the evidence development if we lost the ability to have access to this procedure.

So, again, I want to thank you for hearing me out. I truly think we just need to have access to this therapy, and the evidence certainly proves that it's substantiated and will only get better.

Thank you.

Dr. Eileen Moynihan:
Thank you. So, let me say that I want to thank you all for devoting your time to give us this information today. Your articles and evidence will be very important, so be sure that we have those, particularly your longer-term evidence, very important.

I also want to thank you for your courteousness today. That was appreciated, and since this does involve other MACs, what our usual procedure is, is to wait until everyone is done and then have meetings to discuss the evidence and where we will wind up.

I thought it was interesting that several of you made similar points, but that several of you also made additional different points that added to fill out the pictures. So, thanks for your ability to see what's already been said and add additional important points and just for your time today.

So, Kari, do you wanna take it away?

Kari Dupreez:
Yes, thank you, Dr. Moynihan.

All right, in closing, we would like to communicate the next steps in the policy development process.

The comment period for the proposed LCD will remain open until May 11, 2024. All comments to be considered by our Medical Directors for the proposed LCD must be submitted in writing. Written comments can be emailed to policydraft@noridian.com or mailed to the address on your screen. Comment information for our proposed LCDs are located on our website at noridianmedicare.com

Upon review of the comments, our Medical Directors will either finalize or retire the proposed LCD. Responses to comments will be viewable in the response to comments article.

Please monitor our website or register for listserv notifications to be informed of actions taken on our proposed LCDs. Thank you for attending the Noridian Open Public Meeting today.