Facet Joint Interventions for Pain Management Open Public Meeting - October 21, 2020 - JE Part B

Jocelyn Fernandez:
Good afternoon and welcome members of the public to the open meeting for the proposed LCD: Facet Joint Interventions for Pain Management, LCD number: DL38801 for Jurisdiction E, and DL38803 for Jurisdiction F.

The meeting will be recorded.

The audio recording and written transcript will be posted on our website following today's meeting. All lines are currently being muted by our system and will remain muted throughout the meeting. Only registered commenters will be allowed to comment during today's meeting.

For the commenters, each of 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 comments 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 in your verbal comments. We ask that any comments made today also be submitted in writing. While only registered speakers will be commenting today, anyone in attendance may submit written comments. I will now turn the meeting over to Dr. Eileen Moynihan for comments on this proposed LCD.

Let's give her a moment to connect, I think we lost Dr. Moynihan.

Sorry about that, everyone. Give us a few more minutes, we're trying to connect with Dr. Moynihan.

Hold on.

Dr. Eileen Moynihan:
So, are you hearing me now?

Jocelyn Fernandez:
Yes, Dr. Moynihan, loud and clear.

Dr. Eileen Moynihan:
OK, do you have the slides or do you want me to go back to my email with the slides?

OK, you have to the slides great, thank you. Welcome everybody. Sorry about this. I've been having a little connectivity trouble today. It only started about 15 minutes before the meeting started, otherwise we would have had it worked out, so I apologize. I know your time is valuable.

What you have to comment on today, is the draft that multi-contractors have come up with for Facet Joint Intervention for Pain Management. The entire LCD has been revised, and based on updated evidence review, the multi-jurisdictional CAC meeting that was withheld on May 28th, 2020 via teleconference hosted by CGS Administrators, First Coast Service Options, National Government Services, Noridian Healthcare Solutions, Palmetto GBA, and Wisconsin Physician Service Insurance Corporation.

Next slide, please.

The Facet procedures are a challenging area due to the variability in the literature, the lack of consensus among experts differences in societal guidelines, historical pattern that demonstrates a high risk for overutilization. When there's lack of consensus on best practices, careful evaluation of the medical literature and utilization of the best available evidence serves as the basis for our determinations in coverage and guidelines.

The LCD coverage and guidelines were supplemented with the knowledge shared from our subject matter expert panel.

Next slide, please.

Next.

OK good. These are just some acronyms, which I'm sure you're all familiar with, but in case there's anybody on the call that doesn't know, these are the interpretations of those and by spinal region, we have a cervical slash thoracic and lumbar slash sacral region.

Next slide, please.

We have divided the facet injections into diagnostic, facet joint procedures.

Intra-articular or MBB. The procedure objective is confirm the diagnosis of that syndrome in the policy. If positive, radiofrequency ablation procedure is considered the primary treatment goal at the diagnosed level.

And we have some qualifications to fit here to be a consistent, positive response.

There has to be 80% relief of primary index pain with a duration of relief, consistent with the agent used, or at least 50% consistent objective improvement in the ability to perform previously painful movement and activities of daily living.

Next slide, please.

A second diagnostic facet procedure is considered medically necessary to confirm the validity of the initial diagnostic facet procedure when administered at the same level and the initial procedure had a consistent positive response.

In most cases, there will be two initial diagnostic injections.

The policy allows a maximum of four injections for rolling 12 months. In case, the pain generator is not identified by an initial injection.

Billing with modifier KX is used to distinguish the diagnostic injection. Next slide, please.

The therapeutic facet joint procedures.

The procedures are limited because the facet injection intent is to proceed with radio frequency ablation.

In cases where RFA cannot be performed, then a therapeutic facet joint injection may be covered.

It must be documented, why the patient is not a candidate for RFA, such as established spinal pseudoarthrosis or an implanted electrical device as an example.

There are frequency limitations for each covered spinal region.

No more than four therapeutic facet joint either Intra-Articular or MBB sessions unilateral or bilateral will be reimbursed per rolling 12 months.

Next slide please.

After the patient has had at least two medically reasonable and necessary diagnostic facet joint procedures meeting the criteria in the LCD, an initial RFA may be performed.

Repeat thermal facet joint RFA requires minimum of consistent 50% improvement in pain for at least six months.

There is a frequency limitation for each covered spinal region.

No more than two radio-frequency sessions will be reimbursed per rolling 12 months.

Next slide, please.

For facet cyst aspiration and rupture the intra-articular facet cyst injection requires advanced diagnostic imaging by MRI, CT, or myelogram to confirm compression or displacement of the corresponding nerve root by a facet joint synovial cyst, and clinical and physical symptoms related to the synovial facet cyst must be documented.

There is a frequency limitation here. Cyst aspiration and rupture that may be repeated once and only if there's 50% or more consistent improvement in pain for at least three months.

Next slide please.

There are some limitations to the policy. The imaging required is CT or MRI.

It does not allow for general anesthesia or sedation on a routine basis.

One or two levels, either unilateral or bilateral are allowed per session per spinal region.

Repeat medically necessary and reasonable therapeutic injections or RFA at the same site of a previously treated facet joint may be done without additional diagnostic MBBs if a prior treatment was within the past 24 months.

Therapeutic intra-articular facet injections are not covered unless there is justification in the medical documentation on why RFA cannot be performed.

Next slide, please.

Facet joint procedures in patients with generalized pain conditions, such as fibromyalgia or chronic centralized pain syndromes, is considered not reasonable and necessary. But may be considered on appeal. It’s not expected that patients will routinely present with pain in both the cervical and thoracic lumbar spinal region at the same time routinely. Need for multiple blocks on the same day as facet is not expected to be routine. The need for three level procedures and the routine performance of these may trigger a focus medical review.

Next slide, please.

So there are many, many similarities to the policy we’ve had. The literature had to be updated in the new 21st Century format and process and limitations are somewhat similar but there are a few differences. And I’m sure that you folks commenting are going to tell me about those.

I'm joined by two of my colleagues, Dr. Lurvey who’s on a listen only mode and Dr. Capehart.

So, I would like to welcome Dr. Amanda Crawford and Jocelyn, I don’t know if you have anything to add. Would you like, Dr. Crawford to start?

Jocelyn Fernandez:
Sure.

Dr. Amanda Crawford:
Thank you for having me.

I don't have many comments or questions, just a few here, of concern.

I was, curious, under the first portion, where are we talked about the covered new indications for facet joint interventions.

The draft I looked at described that you had to have the absence of untreated radiculopathy or neurogenic claudication.

And I wanted to confirm that that was, you know, at the same level because I know, for example, the patients with instrumentation of the spine will have radiculopathy at one end then facet disease at the other. And I would hate for a patient with all 3 or 4 facet disease to be denied because of their L5, S1 untreated radiculopathy and intervention, I think, would be sped up if you were allowed to go ahead and proceed with intervening on those processes separately or as soon as possible without having to wait for one to be performed before the other.

The other thing in that scene sub-category would be I'm concerned that sometimes Anatomy precludes you from getting radiculopathy or facet arthropathy intervened upon with one modality. So if we have a rural patient who has access to fluoroscopic guidance, but not CT guidance. I would hate for half of their treatment to be delayed in order to get the referral if we’re waiting for radiculopathy that's anatomically difficult to be treated.

So that's my concern is just that reliance on that having the untreated radiculopathy, that phrase to me, is a little bit concerning. So, I'd love to hear about that.

Then, when we go down to the indications for the therapeutic facet joint procedures. When we ask that there be 80% relief of primary index pain, I wanted to clarify whether or not that was from a VAS score or how we quantify 85, or 80% relief just for my own learning.

And then, my last comment, that was gonna be quick, was that when we're documenting why a patient is not a candidate for radiofrequency ablation, I am curious about, again, the rural patient, who doesn't have access to radiofrequency ablation. Would they be excluded or is there a way to document that they could get inter-articular steroids or, or some other intervention, rather than, especially in the time of COVID. Travels from Montana, down to Utah, or vice versa, if there's the capacity to do a fluoroscopically guided procedure, a facet injection for no temporizing facetogenic pain. So those are my, I think the only comments I have and hopefully what you were looking for. So thank you.

Dr. Eileen Moynihan:
Dr. Crawford. This is Dr. Moynihan, so at the open meeting, generally, we don't answer questions about the policy. But I think, I think you could turn your questions very easily into comments of your concerns, and then supply them, if you haven't already in a written form because I think they're very appropriate and things that the committee needs to think about.

So if you think about the formulation of the policy and taking all the data and different people's opinions and going through all the literature, etc, because things are not consistent on this topic.

It's difficult to have so many people with so many opinions come together so this is our initial pass at the whole thing but not the final pass at it. So, these fine points that you have pointed out, it will be helpful to submit them for consideration, so that we can go through and see where potential holes or points of confusion might be refined better.

So I appreciate these and certainly understand, but have a mind like us to have been, might forgot them by the time we get together. Could you please put them in writing. But I think there are quite able can be turned into comments.

Dr. Amanda Crawford:
Absolutely. Thank you.

Dr. Eileen Moynihan:
Thank you for your time.

Jocelyn

Jocelyn Fernandez:
Thank you Dr. Moynihan for that.

Our second commenter is Dr. Joshua Rittenberg.

Dr. Rittenberg, your line is open.

Dr. Joshua Rittenberg:
OK, thank you. You hear me OK now?

Dr. Eileen Moynihan:
Yes.

Dr. Joshua Rittenberg:
OK, great, thank you. So, yeah, thanks again for having me on, you have my slides too. Great.

So Go to the to the next slide. So I have a few comments, and again, no disclosures.

So the first one relates to the diagnostic facet joint procedures, so the requirement for the second diagnostic facet joint procedure, considered medically necessary to confirm validity of the first one. Yes, we completely agree with that. The comment comes to the second one where the second diagnostic procedure may only be performed a minimum of two weeks after the initial diagnostic procedure. 48 hours seems more reasonable. There isn't a medical rationale for requiring a two week wait.

It is simply requires that the patient's symptoms have returned so that the effect of the local anesthetic has worn off, and that their index pain that we're assessing has returned to baseline. So that duration is really what we need. Not necessarily the two weeks and this can be important for patients traveling a distance. But in general can present delays in care that seem unnecessary for a patient who may go on to have the therapeutic radiofrequency procedure or has been ruled out and needs to look at other treatments.

Go to the next slide.

And diagnostic for sexual procedure. So, the second procedure is considered medically necessary confirmed validity of the initial diagnostic procedure, when administered at the same level. So, we agree with that.

And then the patient meets criteria for this first diagnostic procedure, yes. Then after the first procedure, there must be a consistent positive response of at least 80% and consistent with duration of relief. So, we agree with that.

The comment comes to the next one of them, at least 50%, consistent objective improvement in the ability to perform previously painful movements and ADL, so that I'm not really too clear on how we measure that. If there's a consistent measurement that we're looking for with that I think without a consistent way of measuring it, then then we could risk, you know, overutilization. So I think that part needs to be defined better.

Go to the next slide. Again and this is to the therapeutic facet joint procedures. So required to diagnostic medial branch blocks prior to a therapeutic intraarticular injection that seems unreasonable. You know, generally, when we do an intraarticular injection with local anesthetic and steroids, that can be both diagnostic and therapeutic, there is a percentage of patients who will obtain relief from a single intraarticular injection with the steroids. So in select patients, this may result in significant cost savings over the three steps that would be needed to perform radiofrequency neurotomy.

Go to the next slide.

And then therapeutic medical branch blocks. So medial branch blocks really are diagnostic procedures only using local anesthetic. They're not therapeutic procedures and would not provide extended relief for facet mediated pain. So, the proposed new criteria of at least 50% consistent prevented in the ability to perform ADLs are painful movements. Again, the same thing here, just knowing how to quantify or measure that reliably.

Go to the next slide.

Again, therapeutic facet joint procedures. So, if a patient obtains at least 50% relief from the therapeutic facet joint injection, why require documentation that they are not a candidate for radiofrequency neurotomy. Therapeutic facet injections may be appropriate to perform as the initial intervention and appropriate to repeat in patients that have at least 50% of relief for at least three months. So if a patient doesn't obtain at least three months of improvement from a therapeutic facet injection then it would be appropriate to then perform the diagnostic medial branch blocks to evaluate if they have facet pain that may be amendable to Radiofrequency neurotomy.

Next slide.

And now to facet joint denervation or radiofrequency ablation.

So if we agree the patient has had at least two medically reasonable and necessary diagnostic medial branch blocks with more than 80% relief. Yes, we agree with that. And again the same concern or at least 50% improvement in the ability to perform previously painful movements and ADLs. So again, just how do we measure that, because we really don't have anything consistent.

Most of the outcome measurements aren't really designed for this type of purpose.

The next slide.

OK, and then the next one, so other Limitations.

So there's the recommendation to repeating medical branch blocks after 24 months of pain relief.

So this isn't really necessary if they've had more than 24 months of relief, then a repeat procedure should be permitted at the same level.

These patients, we shouldn't require an extra set of media branch blocks because this would prolong their pain and put them through additional unnecessary procedures, in someone who's responded, you know, for an extended period of time. And then, again, this is inconsistent with the statement six in the list of procedures considered not reasonable or necessary. And that will be denied such as a diagnostic injections or medical branch blocks at the same level as the previously successful RFN procedure.

Go to the next slide.

Then requiring documentation of why radiofrequencies should not be performed in patients being treated with therapeutic intraarticular facet injections than that creates an unnecessary work for the physician that will not necessarily result in improved patient care. So, there may be patients who are good candidates for intraarticular facet procedures, such as someone with, like edematous inflamed joint with surrounding bone edema or whiplash injury.

Go to the next slide.

Provider qualifications. So, consider replacing healthcare professionals with physicians. Physicians have the requisite training for this, for accurate patient selection to safely perform these technically demanding procedures, and to be able to immediately recognize, evaluate, address and a potentially serious, or life altering complications.

That's it. Thank you.

Dr. Eileen Moynihan:
Thank you for those comments. I appreciate your time.

Jocelyn Fernandez:
Our final commenter is Dr. Tyler Ptacek. Dr. Ptacek your line is open.

Dr. Tyler Ptacek:
Yes, thanks for today and the privilege to speak during this local coverage determination.

See my first slide.

So I will state a lot of things that Dr. Rittenberg already stated, particularly the first one is about medial branch blocks.

They are meant to be diagnostic only. There should be a statement that say steroids should be excluded from medial branch blocks because steroids can be, could be particularly therapeutic in a facet joint. There's a little bit of vascular uptake around there, and then the block should not last any longer then the duration of anesthetic, so lidocaine one hour or less, bupivacaine four hours or less.

You can go to the next slide.

There should not be a long waiting period between diagnostic blocks, because the diagnostic blocks are just that. They last for one hour or four hours depending on the local anesthetic used.

Prior to the medial branch blocks, the patients are suffering, suffering from this severe and disabling low back pain, and they've already failed three months of unsuccessful, Conservative cares.

So, we should not put them through another two week period to wait, when we know that the first diagnostic block will not last more than four hours. Oftentimes, I'll have the patient call back to the clinic, literally the same [inaudible].

[Inaudible] talk about the pain score, we talk about their activities of daily living and then a decision is made at that point. The policy should not have a minimum time interval between the diagnostic blocks.

Next slide.

Then this is my last slide. It's very wordy, but essentially basically says that there's an exclusion for three level procedures. In my experience, the patients with Medicare, age 65 and older. We get a CT or MRI of the back and the entire spine is lit up with facet disease. There's no good way to determine whether the pain is coming from each individual facet. And oftentimes, patients who fail a certain level or two level block will ultimately go on to another treatment. And 80% measure of relief from a diagnostic block is a very tall measure to achieve if they're hurting from every facet level in the lumbar spine.

The policy should state a maximum of four levels unilaterally, in cases of scoliosis or three levels bilaterally that may be treated per session. This will minimize the number of patients who do not respond to a facet rhizotomy and, therefore, prevent further utilization of the health care system, such as basivertebral nerve ablations, interspinous process spacer fusions, and pedicle fusions.

It will prevent unnecessary lumbar surgery and opioid prescriptions.

Then my final comment, I actually did not include a slide in here, but just to echo Dr. Rittenberg, consensus that there should be a physician statement and not health care provider.

These are very technically challenging procedures and there are a lot of nuances that require reading MRIs and reading CT scans.

And to prevent overutilization and to increase quality of care there should be a physician who is performing and making the decision for these procedures.

Thank you for your time.

Dr. Eileen Moynihan:
Thank you.

Jocelyn.

Jocelyn Fernandez:
Thank you, Dr, Ptacek and Dr. Moynihan.

This concludes today's open meeting.

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 November 7th, 2020. As noted earlier, all comments to be considered by our medical directors for the proposed LCD must be submitted in writing. Written comments can be e-mailed to policydraft@noridian.com, or mail 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. Please monitor our website or register for listserv notifications to be informed when actions are taken to implement or retire our proposed LCDs, I will now ask if Dr. Moynihan has any final comments.

Dr. Eileen Moynihan:
No, no final comments, Jocelyn. I just would like to thank everyone for their time.

Jocelyn Fernandez:
All right, thank you, everyone. This concludes our meeting for today. Have a wonderful day.