Multiple LCDs: Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease, Cataract Surgery in Adults, Transcranial Magnetic Stimulation (TMS) Open Public Meeting - March 9, 2023 - JF Part B

Kari DuPreez:
Welcome to the Open Public Meeting for 3 Proposed LCDs: Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease, DL37729 for JE and DL37738 for JF, Cataract Surgery in Adults DL34203 for JE and DL37027 for JF, Transcranial Magnetic Stimulation: DL37086 for JE, and DL37088 for JF.

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 to 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 for sharing any personal health information during the 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. Janet Lawrence. Dr. Lawrence, you may begin.

Dr. Janet Lawrence:
Thank you, Kari. Good Afternoon everyone and I have the easy job. I am presenting MRgFUS or Magnetic Resonance Guided Focused Ultrasound.

The original LCD was only for benign essential tremors. Upon receiving a valid reconsideration, and reviewing literature, we extend the LCD to include Tremor Dominant Parkinson's Disease.

So as there are no speakers and no commenters today, this will begin our official comment period. Thank you.

Kari?

Kari DuPreez:
Thank you, Dr. Lawrence. I will now turn this meeting over to Dr. Gary Oakes. Dr. Oakes, you may begin.

Dr. Gary Oakes:
Oh, thank you.

This is Gary Oakes, one of the Medical Directors here at Noridian.

We have the proposed LCD for Cataract Surgery in Adults.

This is not a change in coverage.

But it is a change in the verbiage of the LCD so we wanted to bring it for review and comments.

There was some concern about the use of the words attestation that has caused some angst amongst our colleagues.

So we were able to remove that and remove a lot of the verbiage that should have been in a Billing and Coding article, it was just that we haven't been around to updating this policy.

So that's all been moved to the Billing and Coding article, and I think you'll find this to be a refreshing update.

With that, we have Dr. Craig Kliger who has joined us to provide comments.

Dr. Craig Kliger:
Thank You, Dr. Oakes. And I just want you to know, I did wear a tie for this although there is no video. Anyway, I appreciate the opportunity to present. I will make this short. We strongly support the revisions to the LCD and Dr. Oakes pointed out that it's verbiage that probably should have been in the Coding article in the first place. But that's just a historical issue. And we are very supportive of that.

And we're generally supportive of the changes to the Coding article. There are, as Dr. Oakes pointed out, the term attestation has been, I guess, problematic for some people. People don't know what that really means. Some of the auditors may not know what that really means.

And so, the changes are to support the idea that the chart will defend the basic things that the LCD is looking for, which is a functional complaint and a certain degree of cataract and as long as those things are properly documented and you can find them, that should be sufficient. And we, we appreciate that. There were a few edits to some of the verbiage that we believe is unintentional, but the code for complex cataract surgery uses the term special tools and instruments or something close to that. And the problem is that it has a parenthetical that lists a couple of special tools but over time, we've come to agree with carriers, including Noridian, that certain ones deserve to be explicitly stated.

The one that we're particularly concerned about is something called Trypan blue, or indocyanine green for the use and when a mature cataract is treated because the amount of, will essentially liquify material in the lens makes the capsule that you're trying to create an opening in, almost impossible to see and the dye allows you to do that.

But you would only qualify for the code by using the special tool, which is the dye.

So if you could somehow do it without the dye, then you wouldn't qualify for a complex cataract, but most surgeons think this decreases the risk of a problem. So, we would like to see that the list of things that most ophthalmologists might know but most people reviewing charts might not like Malyugian ring, and there's a few others listed that we would like to see that list maintained so that it's clear to everyone that those special tools do qualify and we hope we will submit a proposed modification to the worded, wording that was published, but we recognize you have the final authority. So, I'd be happy to answer any questions. But we, we appreciate the effort here to simplify this for, for providers, and thank you for the opportunity.

Dr. Gary Oakes:
Thank you, Dr. Kliger. Are there any other comments?

Hearing none, I'll turn it back to you Krista. Thank you.

Kari DuPreez:
Thank you, Dr. Oakes. I will now turn this meeting over to Dr. Raeann Capehart. Dr. Capehart, you may begin.

Dr. Raeann Capehart:
Sorry, having trouble getting off of mute. Can you hear me?

Kari DuPreez:
Yes, we can.

Dr. Raeann Capehart:
This proposed LCD is actually a national contribution, and, oh, we are, it's not, it's not new. It's not a novel but follows along with the other MACs through the country as far as the approval of this particular service.

I believe we have several individuals that would like to comment.

Dr. Blackman.

Mr. Scott Blackman:
Hi, thank you.

My name is Scott Blackman and I'm the Director of Market Access with BrainsWay. Next slide, please.

Although I'm a paid employee, I'm also a member of the Clinical TMS Societies Insurance committee. Next slide, please.

I'd like to just briefly go over the policy or the LCD and some of the limitations that Noridian's analysis conveyed in their summary.

I'd also like to go over briefly the evidence that was supporting Deep TMS or OCD, the relevance for treating OCD in the Medicare population.

I'd like to go over the specific patient that we're discussing and OCD coverage that's occurring throughout the country and other payers.

Finally, the comment on what practitioners should be able to not only order TMS but administer TMS should also be considered. Next slide, please.

The main limitations of the TMS OCD evidence analysis, was that many studies of TMS from the past 20 years plus have been included and combined in order to make a general summary of all studies of TMS for OCD.

But by combining TMS studies which don't use the FDA cleared protocol, is really inappropriate since only one, one TMS system is actually use that protocol and that was the Deep TMS system, which actually gained clearance because of the studies they produced. So, by combining other studies which use different protocols and mixed results, it's not only irrelevant, it's inappropriate.

Of all the information that was sent to all the MACs back in March of 2021, Noridian only references two of them, in their review. And none of the other seven studies were included.

Many other studies to date have been sent to all the MACs and yet those are still not included.

Figure 8 coils, which is the other TMS systems, have not had any studies using the FDA cleared protocol.

So, therefore, by looking at the mixed results and the mixed information and the outcomes and adding that to the only protocol that was approved in those studies is really irrelevant.

Next slide, please.

Because all the protocols were different, and all the studies were different, then the analyses and the summaries that were done by both the CAC when they had the review and also many of the meta-analyses. When looking at all these different studies of different sample sizes, various brain regions that were stimulated at low or high frequency, different numbers of sessions, the outcomes were mixed from either non effective to moderately effective.

And many of the meta-analyses didn't even include Deep TMS studies in their analysis.

So, again, the summaries of all the many little studies that had mixed protocols to come up with a summary, instead of looking at the only one that use the Deep TMS or use the FDA cleared protocol and showed positive effectiveness outcomes. Next slide, please.

I won't go into the study but this is everything that you looked at and the ones in yellow are the ones that you had summaries about.

The top three on the left meta-analyses only two of them, excuse me, two of them didn't even use any Deep TMS and one only used an interim analysis of our initial pilot trial.

The other studies have no Deep TMS. They all have mixed outcomes, mixed brain regions, mixed number of sessions.

So it's hard to look at that and it's easy to get confused. Next slide, please.

A protocol does exist and was cleared by the FDA. And this is the one that was used by Deep TMS. Specific brain regions included the medial pre-frontal cortex and the anterior cingulate cortex at a high frequency of 20 hertz with 29 treatments over six weeks, for about an 18-minute session. Next slide, please.

The point about being relevant to Medicare is, is very important.

Nine. About 62 million beneficiaries are covered by Medicare, with nine million members with disabilities that are under age 65. 34% of those qualify due to mental disorders and 65% of either cognitive or mental impairment.

We're not looking at every patient for OCD. It's a very small number. Of the 12 million Noridian members, only about 27,000 would probably be appropriate to be considered for TMS.

And specifically, those are the patients that fail or fail to respond to their initial treatments. Next slide, please.

Those initial treatments that exist for OCD are either psychotherapy or medications. In the last 30 years, only five anti-depressants have been approved.

The reality is, only 40 to 60% actually get a response. So 50% respond, 50% don't.

If you look at the treatment continuum, you know where they go after that? More of the same.

They just go on to more intense, a partial hospitalization, or intensive outpatient, or else they go to residential facilities. And they're just getting more of the same and probably things that are not approved by the FDA to treat. Next slide, please.

The challenge is that none of them have been shown to be durable.

Studies in psychotherapy showed there's no durability after four weeks, after it stops. Medication has very limited evidence to document sustained effectiveness for continued treatments. Next slide, please.

The point I'd like to reference on this slide is the area that's focused on for the Deep TMS protocol that was approved by the FDA is stimulating the medial pre-frontal cortex and deeper into the brain, into the cortex, to the anterior cingulate cortex, which is about three centimeters subdural. Since it is a circuit disorder, that's what the protocol is trying to do is to stimulate deeper and to stimulate these circuits. Next slide, please.

The point I'd like to make on this slide is that the coils are different. The H7 Coil for OCD goes significantly deeper and broader than some of the other traditional Figure-8 Coils. Next slide, please.

As this electric field diagram demonstrates, if you look at bench top modeling of electric field stimulation, the red indicates the depth and breadth of the stimulation of the TMS stimulation deeper into the brain.

You can see the H7 coil with the red goes much deeper and broader into the brain than the other two coils. And that's significant just so that you can stimulate the anterior cingulate cortex. Next slide, please.

Specifically, the blue region on this slide shows the anterior cingulate cortex. From left to right, you've got the Figure-8 Coils, and on the right top, you've got the H7 coil.

You can see the red area shows a much deeper and broader stimulation and being able to penetrate, stimulate the neurons of the circuitry within the anterior cingulate cortex. Next slide, please.

Of the 16 plus studies that have been conducted on Deep TMS and the treatment of OCD, only two of those were even referenced in the Noridian review.

Next slide, please.

The initial randomized controlled trial, which was our pilot trial of 41 subjects, showed that the low frequency was not really effective like that, and neither was the sham. So they continued to look at the high frequency, which showed efficacy. Next slide, please.

In the large study, almost 100 patients, they showed that 38% of the patients using the Deep TMS protocol actually had a full response, a response being a 30% improvement from their baseline.

You remember, most of these patients have either failed one or more anti-depressants and many even failed psychotherapy.

In the real world, in over 200 patients in the real world, they saw that almost 58% of patients actually achieved a response.

Again, this in the real world, almost six out of every 10 patients achieved a response, and that's really significant compared to patients who did not achieve an initial response on their, you know first line treatments of psychotherapy and meds. Next, next slide, please.

The point I'd like to make is about extending treatment.

If they got a 35% improvement after 29 sessions, giving them 10 more sessions, they got them down to a 50% improvement.

That's significant, because you can take a patient with this chronic disorder from severe to moderate and from moderate to mild where they're actually functioning normal. Next slide.

Speaking of functioning, after looking at patients for over two years in the real world, we saw that their functioning really improved.

In terms of functional disability, patients who are unproductive about five and a half days a week were only unproductive, 1.8 days.

They had a 67% improvement in their productivity.

And in terms of improvement, as far as days that they might have taken off for work because they couldn't function, they only took off no days per week.

There was two years durability and almost 90% of patients had durability to be a year longer. Next slide, please.

Deep TMS we've shown to be the best strategy after they fail SRIs. Next slide, please.

There is a protocol and a criteria and guidelines and CTMS which is for two failed therapies, either two meds or one med and psychotherapy.

Next slide please.

It was shown to be cost effective versus everything the treatment continuum and should be placed after anti-depressants and psychotherapy fails and before they go on to further care in hospitals or residential. Next slide, please.

And finally, you've got over 90 million patients that are being covered members of different health plans and payers from the Blues, Centene, Cigna, Highmark Health Care Services. Palmetto is covering OCD and Premera and Tricare. Next slide please.

In summary, for the treatment continuum when patients fail their first line treatments, before they go on to further other treatments of the same, just more intense and more costly, Deep TMS would be appropriate, and since guidelines haven't come out from the APA, NICE hasn't updated theirs since 2020, Deep TMS would be medically reasonable and appropriate, Next slide.

My final comment on this last slide is many payers are now covering nurse practitioners, non-physician practitioners, other specialties like neurologists, pain specialists, and the point that we're saying is that COVID, we know has identified a shortage of mental health professionals, including psychiatrists. 50 counties in the country do not have psychiatrists. 80% of the primary care write anti-depressants.

The training references, one is by Rossi, which is included in Noridian's references actually, in the guidelines it specifically states that nurse practitioners and other specialists that are treating depression that are trained on TMS should be authorized to not only order TMS if they're already treating depression, but if they so choose, they should, and are trained they also should be able to administer. And last both NGS, First Coast and Novitas are MACs that are actually allowing and covering nurse practitioners, APRNs, and other types of practitioners on the specific verbiage that was in the Rossi guidelines.

And same thing with commercial payers, whether it's many of the Blues, Magellan, I can go on, Cigna, et cetera.

That's all I have.

I appreciate the opportunity to voice these comments for your consideration of coverage of Deep TMS for OCD and other specialists like nurse practitioners and other special physicians. Thank you.

Dr. Raeann Capehart:
Thank you, Dr. Blackman. Now, we appreciate that. And I believe we already have your presentation. If there was anything else that you would like to add to it, if you would, please submit it to us in writing.

But, again, your, your presentation is, is quite thorough, and we appreciate it.

Mr. Scott Blackman:
Thank you again.

Dr. Raeann Capehart:
Dr. Rodriguez?

Mr. Rodriquez:
Hi, hafa adai. I am from Guam. I'm Dennis Rodriguez, the Executive Director for Todu Guam Foundation which operates a health and wellness center.

The Todu Guam Foundation is recognized locally and nationally as a 501(c)(3) non-profit organization. Next slide, please.

We provide healthcare, education support, and services to our people. We have recently expanded our programs to include Deep TMS.

It's fairly new. We have the machine that was just installed last month.

And so now we are focusing on mental health care in our community.

We're hoping with this presentation to seek parody with other states and jurisdictions who allow non psychiatric practitioners to prescribe and order Deep TMS.

Next slide, please.

So Guam is currently an active healthcare provider shortage area, not just with mental health, but across the different healthcare disciplines.

We do have extreme shortages in our physicians. We're a very small community, about 150,000 residents.

For Guam, we only have one full-time psychiatrist that serves the private community.

We have one state run mental health, The Guam Behavioral Health and Wellness Center, which also has one psychiatrist, but only is there for half the time.

Next slide, please.

And, so, in the current solutions are being utilized for rural US territory and other jurisdictions with psychiatric shortages and allowing medical professionals to be able to prescribe and order different types of services from other types of practitioners. Over 80% of anti-depressants are prescribed by primary care physicians and this is no different for Guam. In our, as I mentioned earlier, in our state run Health Guam Behavioral Health and Wellness Center, the medical director is a family practice physician.

They have one, one medical director, they have one clinician who is a nurse practitioner with a support of a psychiatrist, which is only there point five of his time. Certain insurance payers allow alternate prescribers for shortage areas.

And you see a statement here, that, if, due to geographical concerns or in accordance with state practice laws and regulations, a psychiatrist is not readily available, then a provider that has been trained in the use of the specific FDA cleared device may prescribe and/or administer treatment using best practice guidelines.

Next slide, please.

With NGS, you know, we have here a statement that the order for treatment or pretreatment is written by a psychiatrist who has examined the patient and reviewed the record. The physician will have experience in administering TMS Therapy.

The treatment shall be given under direct supervision of this physician present in the area but does not necessarily personally provide the treatment.

With First Coast and Novitas, they allowed NPs and other practitioners to order TMS.

Next slide, please.

So there are other organizations and state and federal programs who recognize studies done by Rossi and Fried and we have those here.

Next slide, please.

So, in closing, in the absence of a psychiatrist, we are requesting that Noridian expand coverage to alternative providers to place TMS orders at equal reimbursements.

We, of course, will practice best use best practice guidelines in ensuring that these practitioners are fully trained in our partnership with a device that we have with BrainsWay.

And by helping us cover this, this gaps in coverage, we can provide TMS treatments to Medicare residents and which really is a lot in our population.

The last report we received from The Guam Behavioral Health and Wellness Center is that of the nearly 800 patients that come through their, that come through their doors in servicing the past 12 months, most of them are, well, all of them are diagnosed with major depressive disorders, all seen by their primary care physicians who are family practice who are, who are prescribing anti-depressants and already are seeing these patients.

And so, we're hoping that, you know, with that and with the shortages that we do have that, they are also allowed to prescribe and order an alternative therapy, which is noninvasive in which we believe with the evidence and data before us, that can be very effective in treating the disorders that our Deep TMS devices could, could treat.

Next slide.

So these are some of the references that we, we, we identify in our presentation this morning.

Thank you very much.

Dr. Raeann Capehart:
Thank you, Mr. Rodriguez. We appreciate your comments.

And, as I just said, if you would either send your slides or a written commentary supporting your viewpoints to us, again, we have to have anything submitted for reconsideration in written form.

Mr. Dennis Rodriguez:
Yes, ma'am. We will be doing that.

Dr. Raeann Capehart:
Thank you.

Mr. Dennis Rodriguez:
Thank you.

Dr. Raeann Capehart:
Ok, Dr. MacMillan?

Are you able to….

Good, thank you.

Dr. Carlene MacMillan:
Yes, yes I am. Alright, hello. Hi. My name is Dr. Carlene MacMilllan. I'm the co-chair of the Clinical TMS Society Insurance Committee as well as a practicing board certified psychiatrist who accepts Medicare in California and several other states. I'm also the Chief Medical Officer of Osmind, which is an electronic health record platform serving almost one thousand independent mental health practitioners across 45 states. I really came here today to emphasize that TMS for OCD can be lifesaving and life changing.

It should be considered medically necessary for treatment resistant OCD patients.

Patients with severe OCD are at an increased risk for going on psychiatric disability, experiencing suicidal ideation, and having suicide attempts.

One thing that I find very striking is that study estimate rates of suicide in OCD patients are 10 times higher than the general population.

Furthermore, without effective treatment, many have somatic obsessions and end up seeking unnecessary, medically unnecessary consultations from medical specialists, as well as many different tests for reassurance seeking behaviors.

In my own practice, Deep TMS using the BrainsWay coil for OCD has allowed many of my commercially insured, as well as well resourced patients to avoid psychiatric hospitalizations for suicidality and very costly specialized, partial hospitalization, intensive, outpatient and residential programs for OCD treatment. Many are able to return to work and to school.

Unfortunately, at this time, our patients with Noridian are unable to access TMS for OCD and as more and more commercial payers and Medicare payers are covering it, this accessibility gap is hard to understand and accept.

As Scott Blackman discussed, the high-quality studies using the FDA cleared protocol clearly support the use of TMS for OCD.

Thank you for considering the point of view of myself and the many clinicians across the country working with individuals with severe psychiatric disability, of which OCD certainly can be.

CTMS will be submitting a formal letter with our recommended guidelines that Mr. Blackman referenced in his presentation.

Thank you so much.

Dr. Raeann Capehart:
Thank you. Dr. MacMillan.

Is there anyone else that would like to comment?

OK, apparently not. I will turn this back over to Krista.

Kari DuPreez:
All right.

Dr. Raeann Capehart:
I'm sorry.

Kari DuPreez:
In closing. Oh, that's fine. 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 March 25th, 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 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 LCDs. Response 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.

Do any of the CMDs have anything else they would like to say before we end this meeting?

Dr. Raeann Capehart:
I do not.

Dr. Gary Oakes:
Nor I.

Kari DuPreez:
All right.

Oh. All right. If not, then this does conclude our meeting. Thank you for attending the Noridian Open Public Meeting today.