Multiple LCDs: Intraosseous Basivertebral Nerve Ablation and Trigger Point Injections (TPI) Open Public Meeting - August 31, 2023 - JF Part B

Kari DuPreez:
Hello. Welcome to the Open Public Meeting for two proposed LCDs, Trigger Point Injections and Intraosseous Basivertebral Nerve Ablation. Before we begin the meeting today, 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.

By signing in today, you are giving consent to the use of your recorded voice and your comments. Please be mindful of sharing any Personal Health Information during your presentation.

In addition to comments that are made today, all comments should also be submitted in writing. All written comments received will be recorded in the Response to Comments article. I will now turn this meeting over to Dr. Eileen Moynihan. Dr. Moynihan, you may begin.

Dr. Eileen Moynihan:
Thank you, Kari. I'm going to introduce Trigger Point Injections and point out that Noridian had a policy, but this particular policy is the Multi-Contractor Jurisdictional policy.

There are some changes to what we had before, including the addition of pain scales and activity scales to pre and post injections, the inclusion of an ongoing program of conservative treatment and the restriction of roughly three sessions per rolling 12 months. Currently, there are no speakers who want to speak at this Open Meeting, and so I'd like to thank everyone for tuning in to hearing about Trigger Points and introduce Dr. Capehart. Dr. Capehart.

Dr. Raeann Capehart:
Yes, can you hear me?

Dr. Eileen Moynihan:
Yes.

Dr. Raeann Capehart:
Good. OK, my name is Raeann Capehart and I'm a Medical Director here at Noridian. We have been asked by several insurance companies, specifically the private plans, to create a policy for Intraosseous Basivertebral Nerve Ablation.

This is a policy that could have been included under several previous pain management policies. But because of a lack of interests and a lack of collaborative effort, we have noted that one other contractor has created a similar policy at the request of the Carolina Pain Society and subsequently we are not exactly reproducing that but do have most of the clinical elements that were included by Palmetto as provisions of this policy. With that in mind, I would like to turn this over to our first presenter we have for today, two of which you have all submitted PowerPoints, and those will be displayed for the following presentations.

Dr. Tekmyster, are you...

Dr. Gene Tekmyster:
Yes, I'm here, thank you for the introduction.

Hi, everybody, I'd like to thank you, for making the time, for me to be able to speak and present. My name is Gene Tekmyster I’m a spine physiatrist, non-operative spine specialist at USC Medical Center in Los Angeles, next please.

These are disclosures, like every talk, the view expressed here are those of mine, clinical expertise and not affiliated with the institution. I'd also like to make note that I do not have any financial relationship with the organization of Relievant which makes this product, Intracept in the past or anything pending for the future, next please. Again, I'd like to appreciate Noridian for taking the time to draft an LCD which is well written, hopefully assist providers and appropriate patient selection and optimizing care delivery. I do like to advise or suggest some changes for clarity, which I will go through in the following slides. Next, please.

I think the use of Modic as an eponym should be secondary and not primary. Most radiologists are not familiar with the term or do not use it. They use more descriptive features, things like inflammatory edema, endplate changes, disruption fissuring of the endplate or any other descriptive findings that are consistent with Type 1 Modic change, which is more of an acute fibrous and inflammatory process as well as bone marrow fat replacement of and hyper intensive signals which is more of a Type 2 Modic change. Again, not using eponyms as we like to often do in medicine, but more of a descriptive factor. So, it can be clearly defined what the MRI findings should be. Again, just because Modic changes as a word, as a tool has not been universally accepted and some are still using descriptive factors, not eponyms, next please.

The absence of non-vertebral pathologist indication is difficult to ascertain. This is the wording in the LCD which I would recommend either removing or editing, next please.

The fracture, for example is for vertebral and is not non-vertebral, is more of a contraindication for the procedure not, you know, absence is an indication. You know, non-vertebral pathology is really best dealt with, like I said, is a contraindications. History, physical examination findings tend to be non-specific sometimes in terms of dealing with vague or confusing complaints. If you wish to edit it in the absence of non-vertebral pathology by clinical assessment, that is not the primary cause of the patient's symptoms including, but, not limited to, tumor deformity or trauma, just because there's a vertebral pathology does not actually mean it's an indication for the procedure as such the presence of other vertebral pathologies such as fracture infections or tumor are best placed in the contraindications setting not in the indication setting being a negative there. Next, please.

This one is what I find the most problematic going forward one of the last indications for the procedure as part of the LCD or the proposed LCD, is screening and evaluation and diagnosis by multi-disciplinary team to include psychological and physical assessment. I believe this will drive up the cost of care by unnecessarily sending every patient for a second opinion as part of multi-disciplinary team or psychological screening. This procedure is not a model to implant. It is very low complication risk in terms of ongoing pain. It is not necessarily affiliated with longstanding chronic pain. The indication is more than six months of pain.

But other procedures that have this requirements such as, for example, spinal cord stimulators are seen in a much more chronic pain population, are an implant procedure that has high rates of [inaudible] on patients. And I'm not sure how this fits into the basivertebral nerve indications. As basivertebral nerve ablation of the vertebral body is probably more closer associated with a posterior ablation, which is radiofrequency ablation with the facet joints which does not have this assessment requirement, no other ablation procedure requires a genicular ablations, cardiac ablation, or all the other ablative procedures that we do from not only a pain specialty, but also cardiology and tumor treatments.

It is difficult for some patients to obtain psychological screening. Most psychological teams, psychologists, and psychiatrists that focus on pain psychology particularly are often absent and do not take insurances. So, for those in lower socioeconomic setting to rely on medical coverage, this may not even be an option to them in more rural areas and depending on what telehealth services coverage will be in the future, this can be a significant detriment to receiving treatment for pain that may eventually lead to functional improvement for some of these patients.

So, I would like to see this removed, if possible, reserved for more invasive treatments like, spinal implants, spinal cord stimulators, and the like. Next, please.

And keeping in line with the FDA indications I think it’d be best to maintain consistency. As previously discussed, there's imaging findings that may be non-specific, don't point to a clear source of the pain. Things like spinal stenosis and neurogenic claudication's. Those are all contraindications, relative contraindications of the procedure. And in order to maintain consistency with what the FDA had stated, it would be ideal to maintain the contraindications and indications as previously written. Next, please.

There are limitations, obviously, but a limitation is not necessarily a contraindication. Contraindications or conditions that increase the potential for harm limitations are needed to assist in defining medical reasonables. I would ask the second contraindication point be removed as it is not necessarily a limitation, but more of a contraindication and evidence of suggested alternative pathology can be inadvertently misplaced by reviewers. Because even though, a patient may have lumbar spinal stenosis or radicular pain, that is not a contraindication to the procedure. It's about finding the optimal treatment for the patient. We don't treat MRIs, we treat patients, and even though spinal stenosis may be present, the patient may not have symptoms or spinal stenosis. They may have symptoms of anterior column pain, which is vertebral body pain, as such, would be amiss, and most some patients maybe not approved or coverage for the procedure where they are indicated for such. So, I ask that, that be reworded, or looked at, ideally removed. Next, please.

Again, I'd like to thank the ability to speak here. But, if there's some of the suggested changes and what are reviewed here, I think it could be more clear in allowing for patient’s access to a procedure that has been quite successfully and consistently proving the literature to be effective while it's not foolproof in a clinical setting in a post release setting. In addition to the clinical trials that were done, this procedure has shown 70 to 80% efficacy rates in appropriately indicated individuals as you have noted in our proposed LCD guidelines here, next, please.

I believe that is it.

Dr. Raeann Capehart:
Thank you, Dr. Tekmyster.

Dr. Gene Tekmyster:
Thank you for your time.

Dr. Raeann Capehart:
I'd very much appreciate these and we will take all of your suggestions into consideration.

It appears that we may need to divide our limitation sections, again, these are generally created for editing but, as you've pointed out, some of these, some of them are very, very difficult to edit as far as medical review.

And one other point I would like to make is, I appreciate your, your not mentioning the fact that our draft LCD uses hypo, hypo sensitivity as opposed to the appropriate term of hypo intensity which I think that our word check here kind of made some corrections to our typing also.

Dr. Gene Tekmyster:
No worries. Again, I appreciate you undertaking this. Overall, I just think if it's consistent with some of the FDA wording, it would be consistent with some of the other LCDs and there are other commercial payers, CIGNA for example is one that are coming out with their own recommendations, and I think consistency is key.

Dr. Raeann Capehart:
I agree. If there are no further comments, let's go on to our next presenter.

Yes, Dr. Wagner.

Dr. Graham Wagner:
Hi. My name is Graham Wagner, I am an Assistant Professor of Physical Medicine and Rehabilitation at the University of Utah and an adjunct, professor of Neurosurgery at the University of Utah, which [inaudible] physiatrist working primarily in non-operative spine treatments. I'd like to echo much with the previous presenter had said and I represent the Spine Intervention Society on this call, not my institution. I don't have any relevant disclosures or financial interest in Relievant or any other financial interest in this procedure.

So, the first thing that I would like to talk about is, that has already been discussed, is the exclusion of patients with any non-vertebral pathology, that, "could" contribute to symptoms. I think this does a great disservice to our patients, as this, Modic changes, or the previously discussed, fiber vascular, or fatty infiltrative, vertebrogenic or vertebral findings on MRI often do not occur in a vacuum. They are often part of potentially a constellation of degenerative findings, which may or may not be present, or patients with these findings, may or may not have pain related to these findings. And other things such as facet arthropathy, disk degeneration, et cetera, are also likely to be present. And so, saying that having any of these other findings that could contribute to symptoms is a contraindication. I do not think is appropriate. And we would like to see specific wording removed from the draft LCD specifically, and I'll quote, "absence of non-vertebra pathology by physical history, radiologic, or clinical assessment, including but not limited to fracture tumor infection to form the trauma, or post-surgical change, which could, could explain or contribute to symptoms or complaints". And what we'd like to see it say, is something more consistent with the NAAS coverage policy, that was heavily incorporated into this LCD, which would say "evidence on imaging, MRI, flexion extension, radiographs, CT, suggesting another obvious etiology to the patient's low back pain symptoms". And we as well as nine other interested medical societies will be submitting a letter to Noridian stating such. But I think that would allow a lot more patients to potentially benefit from this procedure, both in pain and function.

So, the second portion, which had already been, that I'd like to discuss, that was discussed by the prior presenter, was the requirement that patients undergo screening, evaluation, and diagnosis by a multi-disciplinary team to include psychologic or physical assessment. And I will echo a lot of the sentiments made. The studies that were performed that are cited by this draft LCD did not include psychological assessment. And there, I think there are a number of reasons for that. A. you do not, it's not an implanted device, and so, you do not need to, to operate said device. So, like, a deep brain stimulator, or a spinal cord stimulator, which often require some degree of capacity to, to operate the device. That's simply not a consideration here.

You know there are, there are no other similar procedures that require psychological assessments, and I don't see how that would benefit patients in, in this case.

The other issue is that a lot of patients don't have access to this, whether it's because of location, they can’t do psychologic assessments via telehealth. They don't have access, because they're not enough providers that can provide this service. It would just limit the number of patients that can benefit from this, this therapeutic intervention that can be quite helpful to people. And so, like I mentioned, we will be submitting a letter to Noridian stating these points. But thank you for considering these, these points.

Dr. Raeann Capehart:
Thank you, sir. Again, we, we do look forward, and we'll await any changes until we see your written suggestions. But very much appreciate this.

We have another presenter. I believe we do.

Yes.

Dr. Michael Marks:
Yes. Thank you very much. So, I am Dr. Michael Marks. Can you go to our next slide?

And one more, slide. And, so, yes, I'm Dr. Michael Marks. I'm the Senior Medical Director. I'm an orthopedic spine surgeon and Dr. Ray Baker, who is also on this call as our Chief Medical Officer with experience in pain management. You can see the experience that we have, and we're very much appreciative of the opportunity to comment upon this draft Noridian LCD. Each one of us has more than 30 years of experience treating spinal problems and look at coverage policies from various different perspectives. Next slide. And then, one more slide.

My comments because I think it, it's actually becoming kind of obvious that those of us who work in the field of spine that there's consistency in the issues that we have raised. And the fact of the matter is, the FDA indications for use and straightforward, and identify patients that will benefit from basivertebral nerve ablation where we know the procedure is safe and, and, and effective.

It's important that the descriptive terms describing what were originally done by Dr. Modic be included. And that was the reason that in 2019, an additional FDA clearance was obtained using these descriptive verbs that you can see on the screen at this point. Because it became quite obvious that although Dr. Modic first used the terms Modic 1 and Modic 2 in 1988, many radiologists and physicians prefer not to use proper nouns or eponyms. Next slide, please.

Again, this seems to be a clear concern from the two prior presenters and our recommendation absence of non-vertebral pathology that this should be deleted. It creates confusion. The language is currently in the Palmetto LCD and was actually added following the open comment period, and there was no opportunity to comment upon its inclusion. We have experience with appropriate patients for basivertebral nerve ablation being denied. As medical directors and some administrative law judges say, well, that radiographic finding could be the cause of the pain.

This is even after treatments for those conditions have been tried and failed or excluded by physical exam.

As a spine physician, and this was alluded to by, by Dr. Tekmyster and we do vary in age. So, it's nice to know that the training is still there, that we treat patients not MRIs.

This guidance actually comes from a study published in 1990, from my institution, George Washington University, where they demonstrated that MRIs are highly sensitive and not specific. Meaning that they may show findings that are not causing problems. In this study approximately 60% incidence of facet arthritis, spinal stenosis, and disk bulges in patients that attest that they had no history of low back pain or leg pain.

However, patients with axial low back pain and degenerative end plates consistent with those Modic degenerative changes. And multiple studies have a specificity greater than 93%. And this is the reason, the CDC added the diagnosis code vertebrogenic low back pain to the code set in 2021.

There was a regression analysis performed by doctor, Dr. McCormick, which is listed in the slide here that demonstrated that Modic end plate changes remain the most useful patient selection factor for basivertebral nerve ablation. Next slide, please.

Again, seems to be a recurring theme. Inclusion of this last indication, screening and evaluation and diagnosed by a multi-disciplinary team to include psychological and physical assessment. In our opinion, is inappropriate, given the disease process and the actual treatment. This unnecessarily restricts or delays a patient access to care, and, in many cases, has been suffering for years.

In two level 1 studies and in other studies completed, there was no requirement of a screening evaluation and diagnosis by a multi-disciplinary team to include psychological and physical assessment. It's part of what the treating physician does.

It is common in clinical studies to perform a screening of patients to make sure that they do not have conditions that may affect outcomes as they're looking in these clinical studies for an efficacy effect.

In the randomized controlled trials, 1.6% of patients screened were excluded from the studies. This is a low incidence, and therefore, it does not warrant the expense of this additional evaluation.

Again, sort of repeating what has been said as we understand, psychological assessment was being used, initially, for patients being considered for spinal cord stimulator. This is important. These patients must be evaluated to make sure that they're competent, to utilize their pulse generator. Basivertebral nerve ablation is a passive process as far as the care of the patient.

Again, this is the only spinal ablation that has this indications. The results of the psychological assessment does not impact, whether to proceed with the basivertebral nerve ablation. It's almost a check the box.

Having a psychological assessment isn't going to change the thought process and the indications for what needs to be done. It, frankly, only adds to the cost. Next slide, please.

Sort of alluded to also by Dr. Tekmyster. I want to address the list of contraindications that are there from the FDA.

Contraindications are situations where potential harm may come to the patient. The LCD should follow the contraindications that were derived from the FDA. The language around the implantable pulse generator included in the draft is acceptable as it addresses the issue of safety, using and inserting the word active. Next slide, please.

Limitations, we certainly agree that limitations are important. Because this is not a procedure to address all low back pain. Low back pain for the most part, its multi-factorial, and we should be addressing treatments targeted to what is the primary, or predominant problem for them.

That would be akin to having a cardiac patient who has coronary artery disease, valvular disease, and cardiomyopathy. Only being told there's one treatment for all of it. We know that just isn't true.

So, these limitations assist in defining who the procedure may not be medically reasonable. Again, it's not indicated to treat disc herniation, spinal or foraminal stenosis, spondylolisthesis, or facet arthritis. And in most cases, those patients have other presentation that patients with vertebrogenic pain don't have.

And in many cases, the patient has had attempts to treat those conditions, and they still have persistent low back pain. As basivertebral nerve ablation is the most appropriate next treatment.

However, if the clinical exam doesn't support one of those pathologies being the cause of the pain, it's inappropriate for the patient to have an injection procedure, again, just to check the box, it will only increase the cost of care.

Our recommendation is delete limitation number two, as it would essentially by the verbiage, prevent any patient from having the procedure. While limitation number five, ensures that the patients are only limited when the complaint is not their primary or predominant problem.

So, we encourage maintaining limitation number five, as I said, basivertebral nerve ablation is not indicated where there are other conditions that are the primary or predominant problem.

The issue of morbid obesity and in the current wording is too vague, and probably discriminatory. It's hard to exclusively diet to lose weight. It's hard to exercise if you have low back pain. A regression analysis from the clinical studies demonstrated that BMI had no effect upon outcome. Patients with BMI of 21 did just as well as those with 39. The key to outcomes is selecting the right patient and accurately targeting the basivertebral nerve ablation. Last slide, please.

So, we want to thank you for the opportunity to comment upon the draft LCD. The comments are made to ensure that appropriate patients long suffering from vertebrogenic pain obtain the relief they deserve.

Frankly, for me, this is very personal, I am or was one of those for vertebrogenic pain patients. I had to give up a surgical career more than a decade ago because there was no real treatment to resolve my pain. After having had the procedure almost two years ago, I received 90 plus percent relief of my axial low back pain. But I also have spinal stenosis on my MRI that was, at the time, mildly symptomatic. Based upon the current draft, I would've been excluded from having the procedure.

Again, recall, low back pain, is multi-factorial, And we should direct targeted treatment to the predominant problem. We need to get this correct, so that patients don't receive unnecessary treatments, get the appropriate one. And I do want to conclude by saying, I am of Medicare age, and I live in Utah, and I would and am and would be covered by Noridian.

Thank you. And I'm happy to answer any specific questions or comments.

Dr. Raeann Capehart:
Thank you, Dr. Marks. OK, I think you can hear me, my computer seems to be going in and out. Very much appreciate this, as well as your PowerPoint for reference. Are there any other comments?

Dr. Michael Marks:
The final comment is we will also submit some, some written commentary that can support what's here. I appreciate it. Thank you.

Dr. Raeann Capehart:
Thank you. If there are no other comments, I will turn this back, nope, I'm sorry, Dr. Smuck I was not trying to avoid you. You have the floor.

Dr. Matthew Smuck:
Hello, can you hear me now?

Dr. Raeann Capehart:
Yes, yes.

Dr. Matthew Smuck:
Great. All right, thank you. Yeah. My name's Matt Smuck and I appreciate the opportunity to be here on the call and present.

I am Professor and Vice Chair of Orthopedic Surgery at Stanford University where I also serve as the Chief of PM & R.

I'm double Board Certified in PM & R and in Pain Medicine, and I'm here today representing the North American Spine Society, which is a professional society of over 8000 clinicians who treat people with spine disorders and low back pain, including orthopedic surgeons, neurosurgeons, physiatrists and anesthesiologists, radiologists, chiropractors, physical therapists, and the likes.

So, I'll keep my comments relatively brief because I'll just begin by saying everything stated by Dr. Tekmyster, Dr. Wagner, and Dr. Marks, I agree with completely.

NASS, the North American Spine Society is a participant in the 10-society letter that you'll receive with specific comments that are reflected in the things that you've heard here today.

And, so, I'll just use a little bit of my time to focus a little bit more on the science side of things. You know, as an academician and spine researcher, I was also involved in one of the two randomized controlled trials on this technology, and so, Stanford did receive funding for my participation in that research study. But it also allowed me early access to technology, because I was involved in recruiting subjects and, and testing the procedure on them, measuring their outcomes prior to, it’s more widespread use. So, I've had more than six years' experience with the procedure and over 20 years' experience treating patients with a low back pain.

The inclusion and exclusion criteria of the two randomized controlled trials, and the other additional published prospective trials, all use very similar inclusion and exclusion criteria, and those criteria are reflected in the NASS coverage guidelines. And, by and large, you know, the majority of the LCD does reflect the information provided in the NASS coverage guidelines. So, I just want to say that I think, that's a nice, nice reflection of the hard work done by NASS and the and the cooperation and communication between Noridian and the NASS Payer Policy Review Committee and the work that we've put into that, because the development of those guidelines is a lengthy process that involves multiple stakeholders, extensive review of the evidence, and then a coverage guideline based on that evidence.

So, in line with what you've heard before, there are some concerns about specific issues in the criteria that conflict with what is, recommended in the NASS coverage guideline and what's based on the evidence that's been published.

And, in particular, the two points that I've heard over and over on this call on that, I agree with that, the statement about any potential causes of low back pain being an exclusion from the treatment concerns me, because not only does it conflict with what has been published on this treatment, but it would have excluded every patient I've treated while I was involved in the clinical research and while I, and then subsequently, since I've incorporated this procedure into my practice.

The average age of people that receive this procedure as upper 40's. Patients can be, you know, adults of any age, but that's the average age. And as we all know, by the time someone reaches their upper 40's, the odds of them having any type of degenerative finding, a radiologist reportable finding on their MRI is, is nearing 100%, and so that type of the that type of wording maybe wasn't intentional, but can be interpreted to exclude every patient I've treated for this procedure to date.

And second, the psychological requirements are also consistent across studies. As a, as a Board-Certified Pain Physician and as a physiatrist, I'm well aware of the psychological aspects involved in pain management and pain care and a strong proponent of those. But agree with all of the commentators thus far on the call that the way that it's worded in the LCD would be an impediment to care, not an aid to care. And, so, I would like to see that requirement eliminated from the, the LCD. The screening criteria used for the studies was to characterize patients in terms of depression. And, so, depression screening with a depression tool was used when patients were enrolled into the research studies to appropriately screen for patients that have severe depression because of the potential for depression to influence the pain experience and ensure that that gets treated before proceeding with a, with the therapy.

However, that is different than a psychological screen with psychological evaluation and physical evaluation as described in the current LCD.

So, I'm, I fear that many of the patients, especially the underrepresented patients and patients from local, lower socioeconomic status, would no longer practically be able to receive this treatment, if such criteria were, were put into place. And I would hate to see that be an unintended consequence of this LCD.

So, I just wanted to highlight the details from the research studies that I was involved in. As well as the other studies that were done in a similar fashion.

And to note, that the reason you're hearing a consistent concern about these details is that we're, we appear as a group to be approaching this from the same evidence base and the same perspective. And I appreciate the time to point that point out my perspective on it and thank you for your attention.

Dr. Raeann Capehart:
Thank you very much Dr. Smuck. I would like to pose one question to all the presenters regarding psychological evaluation. The particular interest in that for these particular pain policies and, again, this one does seem to have much more of a, a definable clinical indication than some of the others that we've dealt with in the past.

The one provision of psychological evaluation is the determination of the dependence upon let's just say opiates and other addictive medications. And I think this is the reason that those who have been concerned with these procedures have felt that some aspect of psychological opiate management dependency is recommended to be done, not so much as an exclusion to the procedure based on any amount that the patient may be consuming, but more, to, deal with potential, failure of the procedure, failure of indication, when maybe some of the other criteria are not met. If any would, if any of you would like to comment on that, I would be very much interested in, in your opinion.

Dr. Gene Tekmyster:
This is a Gene Tekmyster I didn't start off, and thanking Dr. Smuck for being here and to quote a recent article that he was actually a co-author and that was just published two days ago, which was a pooled analysis of healthcare utilization, it actually showed, that there was a significant reduction of the participants taking opioids at the one-year mark and five plus years after basivertebral nerve ablation, which is statistically significant. So, in regards to your opioid question in particular, which I think is an actually valid, very valid point, this procedure results in less use of opioids, less use of utilization of procedures after treatment, which is a testament to treatment success.

And while the patient may currently be on other methods of pain control, this is a definitive and longstanding effective method for actually reducing utilization of reliance on opioids.

Dr. Raeann Capehart:
Thank you. Are there any other comments?

Dr. Michael Marks:
So, this is Dr. Marks, and, again, I appreciate the ability to, to weigh in on this, and the fact of the matter is that, as physicians, when we see patients, we do a psychiatric or psychological assessment of them. We're checking their mood. We're seeing if they're depressed, and things like that, but, as I stated, that's not going to and should not be an impediment because if you actually and we've got, you know, some of the world's experts on this phone call with me, that when you have chronic pain, you get depressed. You have some anxiety, and because we've not had any great treatments, very frequently, these patients wind up going ahead and needing opioids, which we now know are probably not the best, but they've been taking them now for years, because we haven't had an alternative. We now have an alternative in Dr. Tekmyster just stated, a health economics paper, which we can certainly forward to you, has, has now been published, which clearly demonstrates that these patients use less healthcare resources, less use of narcotics, and at the end, is basically treating their underlying condition. I think the challenge always is when you don't have an objective treatment and you try many of the other conditions, that's appropriate. So again, I think every physician actually does some sort of psychiatric psychological. I think the challenge is, and it's not actually written anywhere, how to specify that, but since we work on behalf of patients, we’re trying to get access to this care, is being used by insurers, and by ALJ judges because of their prior experience with spinal cord stimulator, which mandated a separate screening test for this, that that is how it's being interpreted. I think every physician really does check the psychological status of the patient. Thank you.

Dr. Graham Wagner:
This is Graham Wagner again. I'd also like to say that not every patient that has for vertebrogenic back pain due to these Modic changes is on opioids. So, this doesn't necessarily apply to everyone that, that, that we're seeing. And I think that it's applying less and less as opioids are sort of falling out of favor for, for very good and obvious reasons for treating chronic low back pain. And so, to have this in there is a blanket requirement, really, is just going to add to cost, delay care, and exclude certain patients from this very effective treatment.

Dr. Matthew Smuck:
And again, this is Matt Smuck, I'll just make one additional comment. The concern you raised, I think is a valid one about opioids, and the screening for that, but at least in the areas where I practice, my practice in Michigan, and in California, the pain psychologists really don't focus on addiction and addiction treatment that's a whole different paradigm. And so, if that was the intention, then, that didn't come through to me when I read the LCD. And then, specifically in regard to that, the use of opioids, opiates prior to intraosseous basivertebral nerve ablation was in the minority of patients all of the research study they were talking about. We're talking about a minority population that were on opioids that said, the improvements that patients experience after the treatment was robust enough that, as is mentioned, we're able to demonstrate that, and the year following the procedure, and then maintain over time, they statistically reduce their opioid intake as a group. And so, directly addressing that issue allowed for the improvement that you would want to see in that with regard to that concern.

Dr. Raeann Capehart:
Well, thank you all very much.

I think that that these comments show us that the question that we're asking would most likely be considered in the standard LCD criteria of complete history and physical. Which certainly is required for any Medicare procedure. So, and I do agree that there is no, no true basis for increased cost to undergo the procedure based on a psychological assessment. True psychological exam, which can be quite costly and which Medicare ordinarily does not particularly solicit in terms of, of all of the different aspects that are included in a comprehensive exam, so. If there are no other comments, I will refer back to Kari.

Kari DuPreez:
Alright. Thank you Dr. Capehart. That does conclude the presentations for today, so, in closing, we would like to communicate the next steps in the policy development process. The comment period for the proposed LCD for Intraosseous Basivertebral Nerve Ablation will remain open until September 16th, 2023. The comment period for the proposed LCD for Trigger Point Injections will remain open until September 30th, 2023.

All comments to be considered by our medical directors for the proposed LCDs must be submitted in writing. Written comments can be e-mailed to policydraft@noridian.com or mailed to the address on your screen. Comment information for our proposal LCDs are located on our website at an www.noridianmedicare.com. Upon review of the comments, our Medical directors will either finalize or retire the proposed LCDs. Responses to comments will be viewable in the Response to Comments article. Please monitor our website or register for listserv notifications to be informed on actions taken on our proposed LCDs.

And with that to, either of the CMDs have anything else they'd like to say before we end the meeting today. All right, if not, this does conclude our meeting. We want to thank you for attending the Noridian open public meeting today.