Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) Open Public Meeting - June 10, 2020 - JF Part A

JOCELYN FERNANDEZ
Good afternoon and welcome members of the public to the Open Meeting for the proposed LCD, Percutaneous Vertebral Augmentation for Osteoporotic Vertebral Compression Fractures. LCD number DL34228 for Jurisdiction E and DL34106 for Jurisdiction F.

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I will now turn the meeting over to Dr. Eileen Moynihan for an overview of the Proposed LCD.

DR. EILEEN MOYNIHAN
Good afternoon, everyone and thank you very much for your time, especially during these crazy periods of COVID and everything else that has hit our Nation.

I want to point out that this version of vertebral augmentation for osteoporotic vertebral compression has three changes from the previous.

I'm sure that you've noticed it and that there is a lengthening of the timeframe by including a subacute period of 6 to 12 weeks after the fracture.

There is also a change in the requirement for a multi-disciplinary team and what we were really trying to get at here is that the underlying disease gets attention as well as a vertebral fracture, and the third change has really been the change in language for coagulopathy and to uncorrect it - coagulopathy. So, with that, I'm sure you're quite familiar with the rest of the document and I think we can turn it over to our speakers, Jocelyn.

JOCELYN FERNANDEZ
Thank you, Dr. Moynihan. Our first commenter is Doctor Jason Levy.

Dr. Levy, your line is open.

DR. JASON LEVY
Yes. Thank you very much.

Can you go to my first slide?

So, I want to first thank Noridian and for the opportunity to speak here, and I do appreciate those changes that are certainly in the right direction. I think that it speaks a lot to the procedure, and really the mortality benefits of the procedure. If you could go to the next slide.

Having said that, I do think that we are still too restrictive and I'm going to discuss things four things. Number one: The timing or the fractures. We still have a challenge with older fractures to have edema. Number two: The location of the fractures, this is excluding fractures that occur from T1 to T4. Number three: The exclusion on more than three fractures and number four: I have a recommendation that we include in the inclusion criteria, the number, I'm sorry, the negative effects of narcotics. Next slide, please.

So, I'll start with the timing of the fracture. We do appreciate the increase up to 12 weeks. However, I have two issues with this. one is it's a little bit unclear and unrealistic to expect the ability to get an exact timing of a fracture.

Sometimes there is no definitive time that the patient can rely on reliably give to us as the fracture and this is obviously unrealistic from an MRI or other advanced imaging standpoint to give an exact date of the fracture.

Having said that, one of the things that the rand study discussed was we really should focus on the edema. And keep in mind, that we know that these fractures are not always stable in time Vertos II, Vertos IV, Dr. Bealll’s Evolve Study have all shown that these fractures can go on to continue to worsen over time. So, timing of this is very challenging.

Next slide.

In addition, the literature's that was listed as references do not support this exclusion.

Let's go to Barr in the first place does not support it, does not recommend it. Hirsch, which is the Rand Study in 2018. Again, same thing does not recommend it. In fact, it says quite the contrary, I put this in, highlighted in red, the recommendations on kyphoplasty or vertebral augmentation did not really vary substantially with time. In fact, we should be focusing on advanced imaging and edema, again, because it's challenging to tell when the fracture occurred, did a second fracture occur? So, we need to focus on advanced imaging, not a data point in time.

Next slide.

The other four references, three of them were a no as well, the McConnell, the Clark was a yes, and I'll go over that in a second. DeLeacy, Clarke was, yes. Having said that, though, this was not a study. It was simply a response to an ill-informed Cochrane database suggestion, and really the suggestion was more towards why there were failures in Invest and in Virtuous IV and in the Buchbinder Trials suggesting, and we will have to remember that Invest didn't even do MRIs on all patients, and then finally, in Tsoumakidou guidelines, that actually on the contrary supports chronic treatment for non-union fractures, which is something that all three of the speakers, I'm sure have done numerous times with excellent results.

Next slide.

And in fact, there is evidence to the contrary and I'll just show you these three studies. Two of them are randomized control trials to the actual alternative, which is non-surgical management, not Lidocaine on the pedicle, and the third one is a single arm prospective trial. All of them showing safety and effectiveness in more chronic fractures, subacute fractures, again, focusing on the edema.

Next slide, please.

The second thing I want to address is the location of the fracture, OK, Excluding T1 through TIV. Again, the difference is, unanimously, do not support this, and although it is infrequent to have an osteoporotic compression fracture at these locations, they can occur and when they occur, they occur in the group that is at the highest risk for alternative, which is non-surgical management such as patients with COPD and on steroids. So, let's go to the next slide.

And the six references listed for this, that at 0%, so 0 for 6 recommended excluding T1 through TIV, and in fact, the CIRCI guidelines go in and discuss a procedural approach for the Upper T spine.

Next slide.

The third thing I want to discuss is the number of fractures. Currently, this is listed as an absolute contraindication to have greater than three fractures. There are two problems with this. One is it is very unclear and two, I don't believe that there is significant literature to support this as an exclusion. But let's go over the unclear part, which is probably more important.

This wording does not talk about chronic acute, and I believe the intent here is to for treatment of three vertebral bodies at a single time. But I will give you an example of an MRI. A patient has a quote chronic T5, 6, and 7, and acute T12 fracture, this patient, even though we're planning on treating one level lands as an exclusion, since it simply says three fractures this patient has four.

Next slide.

I'm assuming the risks are about safety with cardiopulmonary risks, and that may be in part related to that the most the vast majority of prospective studies have limited the patient levels to 3 or 2. Although there are some with more, But we really need to balance those risks with each alternative. So the alternative and the negative effects that Dr. Beall has done very well have showing on prior speeches of the risks of non-surgical management and the deep conditioning and the worsening of osteoporosis that occurs with that as well as the opioid use versus the cardiopulmonary risks of treating multiple levels. Again, this is a medical decision and should not be an absolute contraindication.

Next slide.

Again, over five. References listed, there were five of them, and not a single one of them suggested, or reference that there should be an exclusion at more than three.

The Clark study did used to as inclusion for the randomized controlled trial, but none of the 4 used 3. And in fact, there was a reference in one of these references, in the Tsoumakidou and the CIRI guidelines suggesting five or less not three.

So, what is the source of this exclusion as well?

Next slide.

We don't have great data for multiple levels, but there is some data that suggests both effectiveness and safety.

Obviously, two of these are retrospective, one of them is a prospective showing really no significant differences on the number of levels in this study, in the middle study mainly.

Can I go to the next slide?

So, my ask here is that first starters, at a minimum, we have to clear up the language. This leaves a large population of patients untreated. This is data from that the SIR presented to me, from CMS data showing a significant lack of coverage for patients.

I would ask that we have Number 1:Either change it to a relative contraindication, Number 2: allow stage procedures. There are multiple other ways to accommodate this, but again, in the absence of true data, to suggest it in all five references going against that, I would argue that this needs to be removed as an absolute contraindications and allow us to really look at the negative effects of non-surgical management versus treating these patients, especially in an opioid epidemic.

And, then, the next slide, please.

JOCELYN FERNANDEZ
You have one-minute remaining.

DR. JASON LEVY
So, I would also ask that we consider the negative effects of narcotics. This is in nearly every single society guideline that is out there and referenced in the LCD.

So, we have to take into account, and I would ask that we add this as an inclusion, for any patient. This is the warning I gave you with unacceptable side effects. So, this should be added to the inclusion for patients with less than five pain that a stable to improve. The negative effects of narcotics.

So, that is the summary of my discussion. I do have slides at the bottom of this that I asked the doctors who are making this LCD to review that supports this is a low-cost intervention on our society and high benefits. Thank you very much.

DR. EILEEN MOYNIHAN
Thank you, Doctor.

JOCELYN FERNANDEZ
Thank you, Dr. Levy for your comments.

Our second commenter is Dr. Neal Shonnard

DR. NEAL SHONNARD
Running these slides could you, I'm going to go over data that is familiar to Noridian. So, I'm going to travel at a faster pace.

So, my presentation is about data that is intimately familiar to Noridian because the collaborations between Bernice Hecker. Next slide, please, myself, and Justine Norwitz of benchmarking.

What I'm going to show you is comprehensible data, it is your data from Noridian. It's the world's largest BCF registry. It's validated by the source, the Surgical Outcome Research Team at the University of Washington, who Bernice asked to initially develop this when we were building spine scope, and it has clarity on two levels.

Next slide, please.

Clarity on outcomes, and clarity on healthcare utilization. So, when you look at the effect of the exercise of the intended data gathering, it was authorization criteria. The acuity was 4 to 6 months. You mentioned earlier that you thought you had increased the qualification time for authorization. You will in fact shrunk it to three months, it was 4 to 6 months. Originally based on Bernice's recommendation and our concurrence, that MRI edema was the determining factor, that was mentioned earlier, and that's what the original LCD used. We did patient reported outcomes up to three levels because the concern was, women at this age are undergoing more than three level procedure would be difficult, and the recommendation that you have been given to do it as a staged procedure based on the clinician’s determination of when to do the next levels is the wiser approach. There is a conservative treatment part of it and the deleted Pain Management Repulse Bone were part of the original LCD, were deleted.

Next slide, please.

So, it was intended for coverage with evidence development and the insights around the controversy around Percutaneous Vertebral Augmentation. That controversy has not been resolved.

Next slide, please.

There is clear and obvious data that it's a beneficial and impactful treatment, and what happens with the LCD is you immediately restrict access to care, and these women are denied care. In the State of Washington in the first quarter, the LCD in 2014, 6 out of 310 submissions for authorization were authorized. Montana had 0 out of 100 and so, the treatment of these painfully disabled women plummeted.

The health care utilization data came from a $10 million claw back, from one of our local hospitals, and they asked us to help them enroll in the registry and we got the Healthcare Utilization data from them.

Next slide, please.

It's the largest registry. It shows that this is the safest form of treatment, and it has the greatest functional improvement.

Next slide, please.

That data is being published this year in pain position.

Next slide

This is your data.

These are 754 patients, and what you see, a dramatic improvement of severe pain, The average pain score was nine out of ten, you see the minimally, clinically important difference at the top of each graph, it's the color change, the change in pain is two, so going from nine to seven is clinically important to notice . There's a fivefold increase in the minimum clinically important change for both pain and function. What that means is percutaneous vertebral augmentation is profoundly beneficial.

Next slide, please.

This is the world's largest vertebral, compress refractory, and it's almost entirely Noridian data.

So, the healthcare utilization taken from patients enrolled in the vertebral compression fracture registry and came from all charges linked to the indexed ICD-9 for the vertebral compression fracture and there were tracked for six months.

Next slide, please.

And what you see, is there are three tiers. Early treatment of a vertebral compression fracture gives dramatically lower costs, and remarkably high outcomes.

Delayed treatment of six months gives a tripling of the Noridian costs, and they still have beneficial recovery and outcomes. However, they go through six months of pain destitution debilitation and, in some cases, death.

Next slide, please.

These are the two early and late categories. Notice that the early category is treatment within one month, and the cost is lowest. Notice, when you look at the impacts, the Roland Morris is very high. These are functionally disenabling fractures with high pain scores. The pain score on this person was eight. And immediately, after treatment or dropped to one, and over six months, it stayed at one, showing that it is a sustained, beneficial effect. Notice that the cost triples when their care is delayed 171 days and six months. Notice that it is ER visits, re-admissions and imaging costs, and noticed that with the six-month delay, their disability remained high, and their pain remains high. These fractures don't get better, they get worse. Notice, when you look at the recovery of function, the Roland Morris score, they were severely disabled at 20, they went to turn that still a twofold to threefold Improvement in their minimally clinically important difference, so this is hugely beneficial. But notice, it's not the same as the early treatment, which goes from 20 to 3.

So, the delay caused by the LCD harms the patient and diminishes their overall outcome. 3

Next slide please.

So, the intended and unintended consequences. The registry proves that this is the safest and most beneficial form of treatment for every single fracture up to three levels and more than three level fractures that remain untreated will be in the delay treatment category. So, you do not want to limit to three levels. Your own data tells you that you must not do that.

Prompt treatment is the greatest benefit. The lowest cost and delayed treatment causes misery destitution, debility and death and the costs the payer more money.

Next slide, please.

So, remember that the LCD will restrict access, will delay treatment, and the notion of Periosteal Infiltration violates all Orthopedic principles of practical fracture care. We do that for no other fracture and we never do that in the spine, so that is an unproven treatment and should be deleted.

Next slide please.

Your notion of multi-specialty for the management of osteoporosis is thoughtful on your part but there are other ways that we are already doing that. If you want to know about that, I'm glad to tell you.

The summary is you have great list risk of liability because it is proven by your own registry data that this is a highly beneficial treatment, and if treatment is delayed, it's disruptive. It's debilitating and it causes death, about 5300 women die with the original LCD because of delay in treatment. Now, none of us can be blamed for that because we didn't know, but now we do and there is very little gain. Look at the registry data, profound improvement in pain, profound improvement in function and you're not going to be able to improve that or increase that with an LCD. You will only delay.

Thank you. I'm done.

JOCELYN FERNANDEZ
Thank you, Dr. Shonnard, for your comments.

Our last commenter is Dr. Douglas Beall.

Dr. Beall your line is open.

DR. DOUGLAS BEALL
Thank you very much.

Just go into the first slide. Appreciate the time to talk. Let's go onto the next slide. It will hopefully nicely dovetail with the two previous presenters. Next slide please and go forward one place.

So, the two primary issues really for Inclusion Exclusion criteria were the greater than three fractures to the exclusion and inclusion criteria was a consideration of Periosteal Infiltration, and so we have the consideration of Periosteal Infiltration, came from the summary of evidence. So, I'll talk about in a sec and this was the primary reference. This one for VERTOS IV referred the Senior Authors is Dlr. Paul Lohle and Dr. Firanescu the one that we referenced from and this is where the LCD requirements for/or option for Periosteal Infiltration came from and so I would like to make the point is there's no trial at all in this or any of the other the sham trials where Periosteal infiltration alone was used as a sham or a type of treatment option. So, for this trial and I confirm this with doctor Lohle, I corresponded with him this morning. He's a European doctor out of Holland.

That the skin was infiltrated the needles were docked on the outside of the particles, mechanical neurotomy and the, the pedicle was infiltrated, so that was only 1 of 3 and if you add in the patient was I had a sham form of treatment that was 1 of 4 type of the treatments that were offered.

Next slide.

In addition, the other sham trials, none of them had periosteal Infiltration as an isolated treatment and I've listed the other trials, and I won't go over these you can see them as listed. But there is no trial at all in any of the sham trials that had periosteal infiltration as a treatment, including the VERTOS IV trial

Next slide.

In all of the literature, there are some that have infiltration of the posterior elements. But none had infiltration of the Pedicle. The Trials and David Wilson from Professors Wang all injected, and kind of a summary statement of this is very low response for a short period of time. But there's no credible evidence to support the inclusion option for periosteal Infiltration, and I think this is deceptive because there's no literature support whatsoever supporting this inclusion criteria option.

Next slide.

So, as I mentioned, this is one of four different maneuvers, the pedicle docking on the outside of the pedicle, which was confirmed with the authors of VERTOS IV this morning, and they reported all of these maneuvers not just pair pedicle infiltration, as that was part of one in four maneuvers that were taken, and this was political docking on the outside of the Pedicle has been shown to be one of the techniques for mechanical neurotomy.

Next slide.

In terms of the exclusion criteria, the greater than three, you've heard talk about, both by Dr. Shonnard and Levy.

Next slide.

And this is listed as an absolute contraindication, and I think this is nothing more than a simple error. Going back to the UCLA rand Appropriateness Methodology criteria, and this was published by Josh Hirsch last year, it's not even listed as a as a counterindication, much less than absolute contraindication.

Next slide.

So, here's a full listing of the absolute relative contraindications and no more than three vertebral body levels done at one time is not eaten enlisted as a contraindication. In fact, this is really not a contraindication. This is a relative safety limitation, and all of us are aware it was not doing more than three, because the risk of marrow in line to the lungs, especially in people pulmonary compromised. But again,

Next slide.

This is a relative safety limitation is and it's listed as number four under the absolute contraindications. So, what this will do if this is adopted is this will prohibit treatment of some of the most severe patients the patient's severe osteoporosis steroid induced osteoporosis patients with myeloma. There are some trials are greatest et al had 3.36 levels per patient in this trial. Average number of virtual compression fractures in Myeloma is 5.4. and half the patients on steroids induced osteoporosis will have fractures and most of them will have greater than three.

Next slide.

So, what this is similar to do is, it's similar to saying: if you have one hip fracture, you can no longer have another hip fracture in your lifetime, and this is kind of, it's a non-sequitur. And so, the only thing that I can assume that this should have stated as a relative contraindication, at most, that there should be no greater than three vertebral compression fractures levels treated at one time. This should not be an absolute contraindication, as I mentioned it, because it will prevent treatment for the most vulnerable patient populations.

Next slide.

So, the requirement or the option for periosteal infiltration of anesthetic is a treatment for fracture, as we've heard from Dr. Shonnard, is, violates all orthopedic principles, there's no other analogous, supportive treatment for this whatsoever in all of orthopedics. I've mentioned, to you that there's no support for this and the data, in the literature, not a single sham trial nor posterior element infiltration was done with pedicle infiltration is an isolated treatment and I've confirmed in the summary of evidence that this refers to that the Senior Author and the Authors of VIRTOS IV say that this was not done in isolation this was done in one of four treatment methods done for the sham. Again, treating more than three vertebral levels, should be listed, at best, if at all, it best, for relative contraindication. Because this is not even a contraindication, as we've seen, this was nothing more than a relative safety limitation, and what it will do if adopted, as it will prevent the treatment for the most vulnerable patient populations.

With that, I'd like to say I appreciate your attention. Thank you very much.

DR. EILEEN MOYNIHAN
Thank you.

Jocelyn, just one thing.

I know that you know where to find me, but if you would be good enough to send in any article that show that you're not increasing the risk of collapse above and below the repaired Sites. I know I've seen them, but somebody please send that.

DR. DOUGLAS BEALL
Sure.

So, I have a whole book chapter on that. So I'd be happy to send that over and I have PowerPoints, collection of data, and data stating exactly the opposite, including the Sakos trial that says, you can prevent an adjacent level fractures and the top and meta-analysis - It says, you take the adjacent or additional fractures from 22% to 11% when you go from nonsurgical management to vertebral augmentation. So, I'd be happy to send that on.

DR. EILEEN MOYNIHAN
Perfect. I think that could possibly help.

I'm not saying for sure, but I think it might,

DR. DOUGLAS BEALL
You bet.

DR. EILEEN MOYNIHAN
Sorry, Jocelyn, go ahead.

JOCELYN FERNANDEZ
OK, 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 July 13th, 2020.

As noted earlier, all comments to be considered by our Medical Director for the proposed LCD must be submitted in writing. Written comments can be e-mailed to policy draft at Noridian.com or mailed to the address on your screen.

Comment information for our proposed LCDs are located on our website at Noridianmedicare.com and upon review of the comments, our medical directors will either finalize or retire the proposed LCD.

Please monitor our website or register for our listserv notification to be in form of action taken to implement or retire our proposed LCD. Dr. Moynihan do you have any final comments?

DR. EILEEN MOYNIHAN
No, other than, just, again, thank you for your time, especially. It's a crazy time.

JOCELYN FERNANDEZ
OK, this concludes our meeting for today. Enjoy the rest of your day.

Thank you.