MILD CMS coverage determination expected today

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Interesting to read some of the comments: https://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx?NCAId=284

Commenter: Desai, SK
Title:Neurosurgeon
Organization:University of Texas
Date: 04/23/2016

Percutaneous image-guided lumbar decompression for lumbar spinal stenosis does not work. This is an example of pain practices trying to expand their scope of practice and bill for a laminectomy code to counter declining reimbursements.
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If it does not work, then the neurosurgeon is correct. However- if there is sufficient evidence to support its use, then there is nothing preventing the neurosurgeon from employing MILD in their own practice.
 
algosdoc said:
If it does not work, then the neurosurgeon is correct. However- if there is sufficient evidence to support its use, then there is nothing preventing the neurosurgeon from employing MILD in their own practice.
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Yes except:

1) Increase competition from Pain Physicians/Interventional Radiologists/Interventional PMR who can perform the procedure in office
2) Decrease utilization of laminectomy/fusion
3) Decreased reimbursement level compared to fusion/conventional laminectomy

Huge financial incentives to avoid usage of this procedure compared to conventional procedures.
 
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The only reasonable indication for MILD is isolated ligamentum hypertrophy as the sole etiology of spinal stenosis. The next time I see a patient with that pathophysiology will be the first time I see a patient with that pathophysiology. This is a procedure in search of a legitimate indication.

In 2013, Centers for Medicare & Medicaid Services issued a Proposed Decision Memo rejecting coverage for image-guided lumbar decompression surgery in treatment of lumbar spinal stenosis.

Medicare regulators largely questioned the available evidence for the efficacy of the minimally invasive procedure, saying that most of the clinical studies supporting the treatment come from Vertos itself or from physicians with financial ties to the company.

"In reviewing the evidence on [Percutaneous Image-guided Lumbar Decompression] we are confronted with weak studies, questions about missing information, questions about adverse events and conflicts of interest," according to the CMS memo. "After thoroughly reviewing the evidence for PILD for [Lumbar Spinal Stenosis], we have determined the evidence does not support a conclusion of improved health outcomes for our Medicare beneficiaries."

CMS issued a Medicare National Coverage Determination on January 9, 2014 which allows coverage of PILD for LSS under Coverage with Evidence Development (CED) with certain conditions. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=269
 
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ampaphb said:
The only reasonable indication for MILD is isolated ligamentum hypertrophy as the sole etiology of spinal stenosis. The next time I see a patient with that pathophysiology will be the first time I see a patient with that pathophysiology. This is a procedure in search of a legitimate indication.

In 2013, Centers for Medicare & Medicaid Services issued a Proposed Decision Memo rejecting coverage for image-guided lumbar decompression surgery in treatment of lumbar spinal stenosis.

Medicare regulators largely questioned the available evidence for the efficacy of the minimally invasive procedure, saying that most of the clinical studies supporting the treatment come from Vertos itself or from physicians with financial ties to the company.

"In reviewing the evidence on [Percutaneous Image-guided Lumbar Decompression] we are confronted with weak studies, questions about missing information, questions about adverse events and conflicts of interest," according to the CMS memo. "After thoroughly reviewing the evidence for PILD for [Lumbar Spinal Stenosis], we have determined the evidence does not support a conclusion of improved health outcomes for our Medicare beneficiaries."

CMS issued a Medicare National Coverage Determination on January 9, 2014 which allows coverage of PILD for LSS under Coverage with Evidence Development (CED) with certain conditions. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=269
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Well what did we learn from the trial designed by CMS and paid by CMS for mild? (By the way - this new thing that CMS is doing - designing and paying for trials - mild was the first procedure to undergo this process)

We learned that epidural steroids do work for spinal stenosis (cool!).

We learned that mild works way better than ESI for lumbar spinal stenosis (even cooler!) - and for much longer.

As for the neurosurgeon saying it doesn't work - isn't that a little fishy?

Think about it - if you really didn't believe a procedure worked for a condition that you fixed with surgery - why would you say anything? Why would you care? Because if it doesn't work - all those patients are eventually coming to you. You would truly only fear the procedure that kept the patient out of your office.
 
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lobelsteve said:
https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0064076/

http://www.beckersspine.com/orthope...sheds-more-light-on-fda-approval-process.html
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Since you linked this, I have some questions for you.

When CMS decided not to fund MILD, what was this based on? (Hint: your link)

Now that CMS funded a study, what was the outcome of that newer and presumably higher quality data?

With newer, higher quality data, what should one do when comparing this data to older, industry funded data? How should the clinician treat the two data sets? How should one treat comments from neurosurgeons (who clearly have a significant and passionate bias) that are based on the old data?
 
You mean the neurosurgeon who's study was funded by the manufacturer?

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epidural man said:
Well what did we learn from the trial designed by CMS and paid by CMS for mild? (By the way - this new thing that CMS is doing - designing and paying for trials - mild was the first procedure to undergo this process)

We learned that epidural steroids do work for spinal stenosis (cool!).

We learned that mild works way better than ESI for lumbar spinal stenosis (even cooler!) - and for much longer.

As for the neurosurgeon saying it doesn't work - isn't that a little fishy?

Think about it - if you really didn't believe a procedure worked for a condition that you fixed with surgery - why would you say anything? Why would you care? Because if it doesn't work - all those patients are eventually coming to you. You would truly only fear the procedure that kept the patient out of your office.
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epidural man, where are you getting this info? Can you post the link? Did they approve it?
 
Who is paying for studies for devices or drugs that are not sponsored in some way by industry?
 
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lobelsteve said:
Sponsor is Vertos.
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They paid for the equipment. They didn't design the study. They didn't oversee the data. They paid for the analysts as required by CMS.

By the way, the reason we care about industry funded studies is because if the company controls the design and controls the data, it can be designed and analyzed in a way as to create a positive effect when one perhaps didn't exist right? (bias).

Please explain to me how purchasing kits for the physicians introduces bias?
 
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epidural man said:
They paid for the equipment. They didn't design the study. They didn't oversee the data. They paid for the analysts as required by CMS.

By the way, the reason we care about industry funded studies is because if the company controls the design and controls the data, it can be designed and analyzed in a way as to create a positive effect when one perhaps didn't exist right? (bias).

Please explain to me how purchasing kits for the physicians introduces bias?
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You must not do research. I found most interesting that 45% of the epidural patients had moderate sedation. More telling on the practices than on the procedure, but another flag goes up.
 
lobelsteve said:
You must not do research. I found most interesting that 45% of the epidural patients had moderate sedation. More telling on the practices than on the procedure, but another flag goes up.
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Steve.

Explain how a company buying the materials introduced bias (more than investigator initiated studies)?

Also, please give specific and clear details on how the sedated epidural would add bias to the outcome of the study.

By the way, I do research, just not well.
 
epidural man said:
Steve.

Explain how a company buying the materials introduced bias (more than investigator initiated studies)?

Also, please give specific and clear details on how the sedated epidural would add bias to the outcome of the study.

By the way, I do research, just not well.
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Research is not just supplying materials. Exams and evaluations and looking at paperwork all pays very well. Bias introduced. I used to get $1500 cash for injecting knees on a research study for a large company.

Routine use of sedation for epidurals makes me thinks these guys play loose, and care more about profit than patient.
 
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Lobel,

I know your bias is against mild.

However, I suspect you don't do research based on your understanding of how this happens.

Of course people have bias - that is why patients are randomized. Even if the physician is getting reimbursed for the procedure, he was randomized to either the mild or ESI. This helps minimize whatever bias you think is introduced. The same bias is washed out with the sedation.

Walk a mile in someone's shoes - right? So let's do that.

You now have a company for a product/procedure that your really believe in - but you are having trouble convincing people that it works - especially this particular physician in North Georgia. CMS just started a new program where they design the study and ask you to complete it. Your hope is (since they said so) that if you meet endpoints, they will cover it. Also, this is new territory - you are the first company asked by CMS to do this.

Since CMS won't pay for it - no one else will pay for it - you have to get physicians to participate in the study - how would you carry out, design, and finish a study that would convince physicians of minimal bias - especially the brilliant pain physician in northern Georgia? Is it possible? Can a company ever support such a study that would convince physicians that significant bias was reduced enough to believe the data?
 
From my not updated CV:

A Phase IIa, Double-Blind, Randomized, Parallel-Group One Dose Escalation, Multi-Center Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of XXXX Compared to Placebo in Peripheral Neuropathic Patients with Mechanical Hypersensitivity. Principal Investigator


A Multi-Center, Randomized, Double- Blind, Placebo Controlled Trial of the Safety of XXXX for the Prophylaxis of Gout Flares in Patients on Urate Lowering Therapy. Sub- Investigator


A 2- year, Double-Blind, Randomized, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of XXXX (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy. Sub- Investigator.


A Phase I, Double-Blind, Randomized, Single Dose Escalation Safety Study of XXXX in Subjects with Osteoarthritis of the Knee. Sub-Investigator.


2 more as PI and 3 more as sub-I since this was updated.


From last review of MILD: http://painmedicine.oxfordjournals.org/content/15/2/196.long

Only Brown et al was of high quality at that time.
 
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lobelsteve said:
From my not updated CV:

A Phase IIa, Double-Blind, Randomized, Parallel-Group One Dose Escalation, Multi-Center Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of XXXX Compared to Placebo in Peripheral Neuropathic Patients with Mechanical Hypersensitivity. Principal Investigator


A Multi-Center, Randomized, Double- Blind, Placebo Controlled Trial of the Safety of XXXX for the Prophylaxis of Gout Flares in Patients on Urate Lowering Therapy. Sub- Investigator


A 2- year, Double-Blind, Randomized, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of XXXX (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy. Sub- Investigator.


A Phase I, Double-Blind, Randomized, Single Dose Escalation Safety Study of XXXX in Subjects with Osteoarthritis of the Knee. Sub-Investigator.


2 more as PI and 3 more as sub-I since this was updated.


From last review of MILD: http://painmedicine.oxfordjournals.org/content/15/2/196.long

Only Brown et al was of high quality at that time.
Click to expand...
Impressive! That really is. I have no idea how you are able to do that without industry funding. I assumed you were in private practice. I don't know very many people, in fact I can't think of a anyone in private practice that has done phase studies on their own (on a product they didn't develop or help create). Really really cool.

I knew you where a genius.

With that experience, you should be able to answer my question about how you would do the study then.
 
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epidural man said:
Impressive! That really is. I have no idea how you are able to do that without industry funding. I assumed you were in private practice. I don't know very many people, in fact I can't think of a anyone in private practice that has done phase studies on their own (on a product they didn't develop or help create). Really really cool.

I knew you where a genius.

With that experience, you should be able to answer my question about how you would do the study then.
Click to expand...

He didn't.

He just thinks its "cool" to be a contrarian. Kind've like his strawman argument in favor of Elizabeth Warren lying about the Native American thing and attempting to get around it on semantics.
 
lobelsteve said:
From my not updated CV:

A Phase IIa, Double-Blind, Randomized, Parallel-Group One Dose Escalation, Multi-Center Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of XXXX Compared to Placebo in Peripheral Neuropathic Patients with Mechanical Hypersensitivity. Principal Investigator


A Multi-Center, Randomized, Double- Blind, Placebo Controlled Trial of the Safety of XXXX for the Prophylaxis of Gout Flares in Patients on Urate Lowering Therapy. Sub- Investigator


A 2- year, Double-Blind, Randomized, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of XXXX (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy. Sub- Investigator.


A Phase I, Double-Blind, Randomized, Single Dose Escalation Safety Study of XXXX in Subjects with Osteoarthritis of the Knee. Sub-Investigator.


2 more as PI and 3 more as sub-I since this was updated.


From last review of MILD: http://painmedicine.oxfordjournals.org/content/15/2/196.long

Only Brown et al was of high quality at that time.
Click to expand...

How can an independent study setup as a randomized control study exclusively overseen by CMS be "biased"?

I don't see a more independent study design than that.

Clearly, the stuff you "studied" were paid off by big pharma companies who probably did your stats and were far from independent. Who did the stats in your "studies" and who funded them?
 
The one study I did where I got $1,500 for injecting every me was before my current gig. I'm not sure who funds the research we do now but I am paid at a rate of $125 per hour. When I do research currently it costs me money by not seeing the patient I would otherwise be seeing. That is why I'm doing this research at this point in time. I have too many patients I'm trying to help and I only do research patience when I think it's going to be really helpful for them. Even though half the time they're getting a placebo. How about we flipped this topic on its lid and say I'm very much for mild in everybody. We should skip spine surgery and epidurals and go right to mild for anybody with stenosis. What harm would be done? What good would come of it. I believe the standard of care is spinal surgery is decompression without Fusion for spinal stenosis that is symptomatic with neurogenic claudication. I think physical therapy is fairly useless for this and epidurals are effective for a subset of patients. Determining which subset of patients is quite difficult and everybody should undergo a trial of epidural before decompressive surgery. I would not allow this surgery to be performed on anyone in my family because I think this mild surgery is too new and not well enough study to be useful without a known risk benefit ratio. I would gladly recommend simple decompression surgery for anyone in my family had the symptoms and failed epidural injections. I see a huge problem is that if a new procedure that is going to pay very well gets thrown out to the masses of pain Physicians we're going to see a huge number of complications then we're going to ca cause a huge increase in the number of doctors performing the procedures and number of patients who have the procedure done. This will lead to sub optimal outcomes because patients election will go out the window.
 
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lobelsteve said:
The one study I did where I got $1,500 for injecting every me was before my current gig. I'm not sure who funds the research we do now but I am paid at a rate of $125 per hour. When I do research currently it costs me money by not seeing the patient I would otherwise be seeing. That is why I'm doing this research at this point in time. I have too many patients I'm trying to help and I only do research patience when I think it's going to be really helpful for them. Even though half the time they're getting a placebo. How about we flipped this topic on its lid and say I'm very much for mild in everybody. We should skip spine surgery and epidurals and go right to mild for anybody with stenosis. What harm would be done? What good would come of it. I believe the standard of care is spinal surgery is decompression without Fusion for spinal stenosis that is symptomatic with neurogenic claudication. I think physical therapy is fairly useless for this and epidurals are effective for a subset of patients. Determining which subset of patients is quite difficult and everybody should undergo a trial of epidural before decompressive surgery. I would not allow this surgery to be performed on anyone in my family because I think this mild surgery is too new and not well enough study to be useful without a known risk benefit ratio. I would gladly recommend simple decompression surgery for anyone in my family had the symptoms and failed epidural injections. I see a huge problem is that if a new procedure that is going to pay very well gets thrown out to the masses of pain Physicians we're going to see a huge number of complications then we're going to ca cause a huge increase in the number of doctors performing the procedures and number of patients who have the procedure done. This will lead to sub optimal outcomes because patients election will go out the window.
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What you say is true - and likely why mild got killed - people billing way to match for it - and getting paid way to much.
 
lobelsteve said:
The one study I did where I got $1,500 for injecting every me was before my current gig. I'm not sure who funds the research we do now but I am paid at a rate of $125 per hour. When I do research currently it costs me money by not seeing the patient I would otherwise be seeing. That is why I'm doing this research at this point in time. I have too many patients I'm trying to help and I only do research patience when I think it's going to be really helpful for them. Even though half the time they're getting a placebo. How about we flipped this topic on its lid and say I'm very much for mild in everybody. We should skip spine surgery and epidurals and go right to mild for anybody with stenosis. What harm would be done? What good would come of it. I believe the standard of care is spinal surgery is decompression without Fusion for spinal stenosis that is symptomatic with neurogenic claudication. I think physical therapy is fairly useless for this and epidurals are effective for a subset of patients. Determining which subset of patients is quite difficult and everybody should undergo a trial of epidural before decompressive surgery. I would not allow this surgery to be performed on anyone in my family because I think this mild surgery is too new and not well enough study to be useful without a known risk benefit ratio. I would gladly recommend simple decompression surgery for anyone in my family had the symptoms and failed epidural injections. I see a huge problem is that if a new procedure that is going to pay very well gets thrown out to the masses of pain Physicians we're going to see a huge number of complications then we're going to ca cause a huge increase in the number of doctors performing the procedures and number of patients who have the procedure done. This will lead to sub optimal outcomes because patients election will go out the window.
Click to expand...

Once again, the questions were:

1) Who did the statistics on your "studies"?
2) Who paid you the money to "inject" knees or doing the other "payment of 125/hour" on those "studies"?

I suspect you were paid by a big pharma company that did these "studies" at multiple centers where you sent the "data" to their statistician that did a post hoc analysis that found which statistical test gave the highest "clinical significance" for the drugs you were "studying". They hyped up the most marginal of effects to prove "clinical significance" (ex. Lyrica nonsense studies on "Fibro")

I know this for a fact since I see Pfizer doing this for a new "study" on a pain drug they are pushing where they are basically excluding 99.9% of patients they would give the drug to and have their own stats guys doing the analysis of the "data" they collect from many different sites they "pay" to do their "study".
 
lobelsteve said:
Paid only by Medical Associates of North Georgia. as an employee. no outside interest, investment, or holdings.
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Oh ok, sounds legit if true.

I find at least 95+% of "research" on pharmaceuticals being funded by and managed statistically by the company that produces the medication.
 
DrCommonSense said:
Oh ok, sounds legit if true.

I find at least 95+% of "research" on pharmaceuticals being funded by and managed statistically by the company that produces the medication.
Click to expand...

Agree completely. currently doing an oral drug study for crps. fair inclusion criteria, lenient exclusion criteria. No takers yet. everyone wants LSB, PT, and Lyrica.gabapentin.
 
Sounds like your medical association is making money off clinical trials and paying you for the work you do for it. It's nice to try and turn a blind eye but don't post those things from your CV when you are trying to make a point about the opposite
 
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Jigsaw said:
Sounds like your medical association is making money off clinical trials and paying you for the work you do for it. It's nice to try and turn a blind eye but don't post those things from your CV when you are trying to make a point about the opposite
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Interesting point and confirms the argument I was making before.

Who is paying their medical association to conduct these "studies"? Also, who are doing the "stats" for these "studies"?

By the logic of people who are "purists" about funding sources for medical studies, they should FIRST take their own names off any medical studies that obtain funding from sources that have a "conflict of interest" in the treatment/medication.

Funny how these "purists" will hypocritically conduct "research" when they get paid by the company conducting the "research" while at the same time questioning other research done by other companies in the SAME manner or even less biased manner.
 
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DrCommonSense said:
Interesting point and confirms the argument I was making before.

Who is paying their medical association to conduct these "studies"? Also, who are doing the "stats" for these "studies"?

By the logic of people who are "purists" about funding sources for medical studies, they should FIRST take their own names off any medical studies that obtain funding from sources that have a "conflict of interest" in the treatment/medication.

Funny how these "purists" will hypocritically conduct "research" when they get paid by the company conducting the "research" while at the same time questioning other research done by other companies in the SAME manner or even less biased manner.
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I am not an owner, nor am I paid per anything other than per hour. I have no joy in research.
 
Appreciate that Steve is contributing to research in our field.
 
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lobelsteve said:
I am not an owner, nor am I paid per anything other than per hour. I have no joy in research.
Click to expand...

Yes but when you obtain the data from your research, who does the statistical analysis of such "data"?

Also, are there multiple centers involved in the same protocol or just yourself?

That is the real determination as to the integrity of the study.

Look at Lyrica for "Fibro" pain. It shows approximately a 2--5% benefit over placebo for "fibro" on VAS scores under their most aggressive analysis and have somehow convinced people that paying 700/month for a "disease" that is impossible to actually diagnose objectively is a prudent usage of resources.

Interesting how that works.
 
Agree that I don't see lyrica helping that many FMS patients. I saw more improvement with SNRIs and/or qhs TCAs.

But I don't see fibro anymore at least not as the sole diagnosis.
 
lobelsteve said:
Paid only by Medical Associates of North Georgia. as an employee. no outside interest, investment, or holdings.
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Who is paying Medical Associates of North Georgia?

Sent from my SAMSUNG-SM-N930A using SDN mobile
 
parenthetically -

The mild patient I did two weeks ago - seen in the clinic this week, is pain free, except has a lot of muscle pain from doing too much on the treadmill.
 
ampaphb said:
Who is paying Medical Associates of North Georgia?

Sent from my SAMSUNG-SM-N930A using SDN mobile
Click to expand...

Northside bought us 3 yrs ago. they get paid by the sponsor. but before that, there was a research department here. they negotiated contracts and kept the records, labs, schedule, etc.
 
lobelsteve said:
Northside bought us 3 yrs ago. they get paid by the sponsor. but before that, there was a research department here. they negotiated contracts and kept the records, labs, schedule, etc.
Click to expand...
So SOMEONE at NGMA is getting rich on these studies; it's just not you
 
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So there is no such thing as non indrusty funded studies in some way
 
Jigsaw said:
So there is no such thing as non indrusty funded studies in some way
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Correct.

Same thing goes for the NEJM and big pharma articles. Here's the former editor in chief of the NEJM admitting the corruption between NEJM and big pharma:

https://ethicalnag.org/2009/11/09/nejm-editor/

Most of the big pharma studies are conducted by physicians who are "consultants" for big pharma.
 
Maxfli said:
Anyone got any updates on this. We just got word from the rep saying we can start using again in Medicare patients using CED (Coverage with Evidence Development). I'm not sure I'm buying it, it says we have to submit it with a clinical trial identifier that he gave us.


https://www.cms.gov/Regulations-and...smittals/2014-Transmittals-Items/R2959CP.html
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I just spend some time reading stuff on the CMS website.

I think government generally misses the point most of the time - and usually are very corrupt and tend to help money interests (think FDA) - but in this case, they seem to have got it right.

First, they made Vertos perform a RCT. Now after the RCT, they are allowing coverage, but only in a longitudinal fashion in a study...meaning..now they want to track patient outcomes for a long time. That is a brilliant idea, and the right way to do medicine.


This also helps VERTOS, because the document says they will only allow devices that have completed the CMS approved RCT, to get funded for the longitudinal study. I am only aware of one company that has completed the CMS approved RCT.

https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=284
 
epidural man said:
I just spend some time reading stuff on the CMS website.

I think government generally misses the point most of the time - and usually are very corrupt and tend to help money interests (think FDA) - but in this case, they seem to have got it right.

First, they made Vertos perform a RCT. Now after the RCT, they are allowing coverage, but only in a longitudinal fashion in a study...meaning..now they want to track patient outcomes for a long time. That is a brilliant idea, and the right way to do medicine.


This also helps VERTOS, because the document says they will only allow devices that have completed the CMS approved RCT, to get funded for the longitudinal study. I am only aware of one company that has completed the CMS approved RCT.

https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=284
Click to expand...

ALL devices covered by Medicare should have the SAME standards applied in the future! Same for big pharma

Problem is the corruption will never allow this.

Imagine if the fusion devices required the same level of scrutiny before Medicare paid for fusion surgery.
 
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