Intervertebral Disc Repair Open Public Meeting - October 7, 2024 - JE Part B

Taylor Canova:

Good afternoon everyone and welcome to Noridian’s Open Public Meeting. My name is Taylor Canova, and I am one of the Medical Policy Specialists here at Noridian Healthcare Solutions. We will be presenting the Intervertebral Disc Repair LCD.

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. Those registered to present will be allowed to comment on the proposed LCD today.

For the presenters, you are being allotted 10 minutes to make comments. Your line will opened when it is your turn to speak. Make sure you are not on mute within your system, or we will not be able to hear your comments. You should be prepared to begin your presentation immediately when called upon and will hear the moderator's voice when one-minute remains. If you reach the end of your 10-minute time limit, your line will be muted, and we will  move on to the next speaker to allow all registered commenters time for their presentations.

We have added a closed caption feature in real time for today's call. Please speak clearly to ensure 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 this meeting over to Dr. Eileen Moynihan. Dr. Moynihan, you may begin.

Dr. Eileen Moynihan:

Good afternoon or whatever time of day it is for any of you. Thank you so much for coming to give comment on this LCD or for just even listening. We value your time, and we value your input.

This is an LCD that is a multi-contractor LCD. However, not all contractors are taking it at this time. I wanted to point that out because some people were trying to register but missed the deadline for Noridian and for Palmetto, and CGS will still be having an Open Meeting in the next week or two.

So, if you know of colleagues who were unable to make the deadline to comment at an Open Meeting, just remember that for a multi-contractor LCD, you really only have to speak to one of the contractors in order to get your comments in the Open Meeting. We still require written comments to come in after the LCD, before the LCD comment period closes.

This particular LCD, we began to look at the subject matter and found that there were several interesting substances being injected into the spine that may or may not have a lot of scientific evidence backing them. So that is the reason that this LCD appears before you.

And I think at this point in time, we can move on to our first speaker. Are the slides supposed to advance here? Okay. Dr. Lorio, would you like to start now?

Dr. Morgan Lorio:

Yes. Yes, please. Thank you.

So I'm Morgan Lorio, president of ISASS, and I'd like to address this. We submitted a letter. It's rather lengthy. I could break it down, but I think probably just because of time limitations and clarity, I think we can boil it down and then kind of rehash it just a bit.

The most egregious problem with Noridian’s argument for non-coverage is their failure to provide specific evidence or analysis related to VIA Disc NP, despite proposing non-coverage for all intradiscal injections, including VIA Disc NP. This violates Medicare Program Integrity Manual, which mandates non-coverage determination must be based on a thorough review of evidence for a particular product in question.

Noridian’s proposed LCD conflates VIA Disc with VIA Disc NP, two distinct products, and bases its coverage decision on outdated data regarding a product that has not been on the market since 2021. That is the distillation of the problem and why I've chosen to talk or speak to this format, these folks here, and I appreciate you listening to me.

I'll go into some more specifics. The proposed LCD discusses nine different items or classes of items, and again, conflates VIA Disc matrix with VIA Disc NP. They're different products. The data has been presented for VIA Disc NP, three specific studies. The results presented are significant.

Probably one of the last things I'd like to get to, because our letter was rather self-explanatory, is the fact that items such as platelet-derived plasma has its own code, and yet it's included within this coverage rationale as well. Again, now we're conflating codes 0232T with 0627T. So the entire thought process behind this is rather confused, and that's why ISASS has chosen to speak to you in this regard.

So I'll reiterate, the proposed LCD does not meet legal requirements, as it fails to discuss evidence specific to VIA Disc NP. Two, VIA Disc NP is incorrectly included in the proposed LCD, as it is not an intervertebral disc repair product. Three, any final LCD must be based on the evidence specific to VIA Disc NP which currently supports its coverage. Number four, there is inconsistency between the proposed LCD and the draft article, with the latter only identifying non-covered codes for certain therapies. And number five, the proposed LCD's blanket non-coverage for all intradiscal injections is unsupported by a thorough evidence review for all individual therapies.

Thank you.

Dr. Eileen Moynihan:

Thank you, Dr. Lorio. And so now we'll move on to Dr. Naidu.

Dr. Ramana Naidu:

Yes, thank you so much for allowing me to speak today. My name is Raman Naidu, full name is Ramana, and I work in the San Francisco Bay area within the Noridian jurisdiction.

I am the co-founder of the Pacific Spine and Pain Society, which is a regional society that is really focused on bringing spine surgeons from an orthopedic or neurosurgical background with interventional pain physicians, whether they're from anesthesia, PMNR, neurology, family practice, et cetera.

And I think one of the challenges for everybody, whether you're sitting at the desk at Noridian or you're a patient or you're a doctor, is seeing this burgeoning field of interventional spine coming into play in the last five to 10 years and trying to sort this all out. So I can totally understand your frustration in seeing a lot of these various products and wondering what is right and what is wrong.

What I'd like to go over today, if you can switch to the next slide, is sort of what Dr. Lorio said. Grouping all of these intradiscal therapeutics and proposing non-coverage would be a massive failure for our patients. There's no question a number of these products unfortunately have not panned out as far as their efficacy and with some safety risks. But to say we need to avoid the disc entirely again would be a failure. It would be like saying we would never do an intra-articular knee injection of any type. Yes, there are pros and cons to certain substances as we've all known, but we're continuing to study and continuing to get better at that.

Similarly, the lumbar intervertebral disc is a joint, just like your knee or your shoulder is just a very different joint than what we're accustomed to as laypeople.

It's gone through trials and tribulations, but what's been really gratifying is to see the work and effort in trying to justify intradiscal therapeutics such as VIA Disc NP.

The reason I'm speaking about it is because I was involved in the six-month and 12-month VIA Disc NP study. And we have the data, which Dr. Lorio pointed out, demonstrating efficacy, safety, and long-term benefit for our patients.

The problem I have with this proposed LCD is that if it could potentially affect access to care throughout the country, especially as you have multi-MACs being involved, we already know Noridian does not cover this procedure, so I can't even do it right now through Medicare. But nonetheless, if this proposal of non-coverage goes across the country, this is really gonna limit our ability to even do the research to really understand what is right and what is wrong.

So again, I'm not saying I condone specific intradiscal therapeutics, even though there's promising data to support VIA Disc NP, non-coverage would really limit our ability to see what this does for our patients. So I really strongly urge you not to have non-coverage for intradiscal therapeutics in specifically this one and whatever potentially might come out as we're early in the process of looking at intradiscal condoliase, an enzyme that's been used in thousands of Japanese patients with good effect.

So again, this is a massive problem in a lumbar discogenic pain, and we need solutions. If we don't have those solutions, frankly, as you already know, patients are either gonna be left with medications or surgery. And surgery is only effective for very specific discogenic situations, not all of them. Medications, even though yes, of course we're trying to avoid opioids, it's not just opioids. I mean, just think about the gabapentinoids, which have their impacts on falls risk, NSAIDs, then cardiovascular risks, renal risks, et cetera.

So really the future of interventional spine is really trying to obviate really risky procedures and really risky medications. And so that's why, you know, I want to see access to care maintained.

As Dr. Lorio already mentioned, everything was kind of grouped in, PRP, mesenchymal stem cells, whatever else was all grouped in for the intradiscals. Unfortunately, you can't be that general. You have to look at the specifics and look at the data. Of course there's some failures. There's some things that I would never ever introduce into a patient.

However, I do have that confidence with VIA Disc NP just based on my own experience, and that's why I don't want to see this fall to non-coverage nationally. Dr. Lorio already mentioned that a lot of the data has been missing from the review, and so we'll be happy to provide that for you.

And then last but not least, you know, Pacific Spine and Pain Society, which I already mentioned, a unique regional society bringing in spine surgeons, interventional pain, supports not allowing this non-coverage policy to go through.

You also have, in addition, ISASS, the American Society of Pain and Neuroscience, and several radiological societies, which are, again, all in unison saying we can't lose our access to care for intradiscal therapies, especially, obviously, those that have good data and evidence to support their use.
So with that, I thank you so much for this time, and I hope you'll take our comments seriously. Thank you.

Dr. Eileen Moynihan:

Thank you for your comments. And again, everybody, please be sure that if you have comments, we receive them in writing. And now I'm going to turn it back over to Taylor or Kari to go over the closing and next steps.

Taylor Canova:

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

The comment period for the proposed LCDs will remain open until October 12th, 2024. All comments to be considered by our Medical Directors for the proposed LCD must be submitted in writing.

Written comments can be mailed to policydraft@noridianmedicare.com or mailed to the address on your screen. Comment information for our proposed LCD is located on our website at noridianmedicare.com.

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

Dr. Moynihan, do you have anything else you would like to say before we end the meeting?

Dr. Eileen Moynihan:

Just want to thank everyone again for their comments and for their time. We really appreciate it. Thank you.

Taylor Canova:

Thank you for attending the Noridian Open Public Meeting. Have a great day.