National Coverage Analysis (NCA) View Public Comments

Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis

Public Comments

Commenter Comment Information
Novelli, Thomas Date: 11/16/2013
Comment:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (“CMS”) proposed decision memorandum for Percutaneous Image-Guided Lumbar Decompression (PILD) for Spinal Stenosis (CAG-00433N). MDMA represents hundreds of innovative medical technology companies that improve the health of millions of Americans, including a significant number of Medicare beneficiaries.

MDMA is concerned about the recent proposed decision memo and its implication on the

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Robinson, Wendy Date: 11/16/2013
Comment:
[PHI Redacted] is a 70 yr old man recently had the MILD procedure, before this he was hardly able to even walk to the mailbox without having extreme pain. [PHI Redacted] had always been a very active father and grandfather and is inability to walk distances and attend family functions had taken its toll on him. Since having this procedure done he is able to grocery shop for his family, take walks with his grandchildren and actually spend quaility time with his

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Paquette, Brian Organization: Indiana Polyclinic, Indianapolis, IN
Date: 11/16/2013
Comment:
This initial decision by CMS appears to be irresponsible at best, given the available data supporting this procedure. MILD has positively impacted 100% of my patients. These patients, two years post procedure, have not warranted further surgical intervention of any kind. I have been well trained in this procedure. My patients have been well selected for MILD. 100% of the patients, to whom I have delivered this care, have had clinical evidence of neurogenic claudication and radiographic

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Wright, MD, Ballard Title: Physician
Organization: Ballard Wright, MD, PSC aka The Pain Treatment Center
Date: 11/16/2013
Comment:
I am disappointed that CMS has proposed to eliminate coverage of the MILD procedure for the following reasons:
1) the procedure is being eliminated in the population of patients who most need an alternative to open surgery for Lumbar Spinal Stenosis
2) this procedure allows those patients quick recovery and mobilization
3) this is a cost effective procedure, as compared to the open surgery, as it requires no hospitalization or general anesthesia
4) as a 76 year old

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Trivedi, Shweta Title: Manager, Health Policy and Practice
Organization: North American Spine Society
Date: 11/16/2013
Comment:
CMS’s Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N)

http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=269

NASS Response:

Commenter:
Scott Kreiner, MD
Organization:
North American Spine Society
Date:
11/16/2013

The North American Spine Society (NASS) is a multidisciplinary medical

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Coleman, Neal Date: 11/16/2013
Comment:
My experience as a physician is quite positive and in line with the published studies on MILD. Over 75% of my patients improve substantially. None of them have had to be admitted for the post operative care. I have no complications of infection, bleeding, nerve dammage, dural tear, nor spinal headach post procedure with the Vertos method of MILD. Less than 20 percent have failed to improve and or needed to have open surgery. Many of these patients were unable to walk 50 feet and after the

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Falco, Frank Title: Immediate Past President
Organization: American Society of Interventional Pain Physicians
Date: 11/16/2013
Comment:

The American Society of Interventional Pain Physicians (ASIPP) welcomes the opportunity to comment on the draft National Coverage Analysis (NCA) for Percutaneous Image-Guided Lumbar Decompression (mild) for Lumbar Spinal Stenosis (LSS). According to the NCA comment posted by Vertos Medical on May 5, 2013 over 90% of physicians using the mild procedure are Interventional Pain Physicians so we feel compelled to provide CMS with the perspective of the treating physician on this decision.

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Ko, MD, Timothy Title: Interventional Pain Specialist
Organization: Pinnacle Interventional Pain and Spine Consultants
Date: 11/16/2013
Comment:

I have been performing this procedure on my patients for the last two years. I am a interventional pain management physician that performs advanced spine procedures that include implantable pain devices. I enter the spine 50-60 times a week with the procedures that I do to help control pain and suffering.

Of all the options available to me I find the PILD to be the most innovative and minimally invasive means to deliver relief to my patients. This procedure is cost effective,

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Meyer, J Title: President
Organization: MED-CARE, INC
Date: 11/16/2013
Comment:

I have done 21 image-guided lumbar decompression procedures for my patients who have lumbar spinal stenosis and associated neurogenic claudication. 13 of those 21 patients have reported excellent pain relief and 4 of them have been pain free since I did their procedures. One of the pain free patients had his procedure done 15 months ago.

I looked at the other patients on my MILD list and 12 of the 21 patients have had significantly reduced office visits since having their procedure

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Schnedier, Jeffrey Title: Medical Director
Organization: National Spine and Pain Centers
Date: 11/15/2013
Comment:

Jeffrey Schneider – CMS Comment
I am a former Interventional Pain Fellow, and Chief Resident for the Department of Anesthesiology for Robert Wood Johnson University Hospital. I have been honored with the distinguished service award for the department of Anesthesiology at Robert Wood Johnson Medical School. I treat patients with chronic spinal pathology in my private practice on a daily basis, and have performed PILD procedures for many patients. I have also witnessed the psychosocial,

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Griffith, Patrick Organization: Pain Source Solutions
Date: 11/15/2013
Comment:

As a practicing pain management physician for the last 20 years, treating patients with lumbar spinal canal stenosis has always been a challenge. Conservative therapies including physical therapy, medications and epidural steroid injections are helpful but at times only short term. These patients are then referred to a neuro or orthopedic surgeon who, based multiple variables, may or may not deem the patient a reasonable candidate for surgery. Now, this assumes that I am able to talk my

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Davis, Karen Title: Vice President of Clinical Research
Organization: Vertos Medical, Inc.
Date: 11/15/2013
Comment:

Vertos Medical appreciates the opportunity to comment on the NCA Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (PILD). CMS has proposed a non-coverage decision based on a number of factors. Our comment will respond to five fundamental concerns raised by the Coverage and Analysis group in the draft NCD: 1) Diagnosis and treatment of LSS, 2) Level of Evidence on PILD, 3) PILD mechanism of action, 4) PILD Patient Selection and Diagnostic

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Cha, Daniel Date: 11/15/2013
Comment:
I have performed at least 15 mild procedures and have seen a significant change in functional capacity in at least 90 percent of my patients. I find it hard to believe that cms has not see this as a beneficial procedure for patients. Many of these patients were not surgical candidates and have not responded to all other conservative measures. It would be a major disservice to the people of this nation for the mild procedure to be considered not effective in treating stenosis
Stilwell, M.D., Anne Marie Title: Doctor
Organization: Anne Marie Stilwell, M.D., P.C.
Date: 11/15/2013
Comment:

I am an interventional pain medicine specialist who has performed this procedure. Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis has improved all of my patients lives by allowing them to walk again. Lumbar spinal stenosis symptoms of back pain and pain down the legs with standing and walking comes from pressure on the neural contents of the lumbar spine. One of these contents that enlarges with age is the ligamentum flavum. I have found in the procedures that

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Fallows, Mark Title: President/Owner
Organization: Pain Institute of Central Florida
Date: 11/15/2013
Comment:
This procedure has significant evidence supporting it's efficacy and safety. Objection to approval of the procedure is mainly from members of NASS that feel this procedure encroaches upon their turf. This is not true. This procedure benefits precisely the patients that have either failed other therapies or are too unstable to undergo a more invasive procedure. The potential to help many people, most of them elderly, is important as it does so in a very cost-efficient manner and with minimal

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Goldstein, MD, Robert Title: Associate Professor, Director Pain Management Cent
Organization: University of Virginia
Date: 11/15/2013
Comment:

I strongly request that the Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis Procedure, otherwise known as mild procedure, be fully and unconditionally authorized, certified and reimbursed. As a practicing Pain Medicine Specialist and Medical Director of the Pain Medicine Division at the University of Virgina, I feel this technique has great value, significant safety and cost savings for pateints and the health care system.

Please consider the risks of

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Chapman, Kenneth Organization: The Spine and Pain Institute of New York
Date: 11/15/2013
Comment:
The MILD procedure is a procedure that has provided numerous patients of mine good long term relief. The data for this procedure is well documented and we as pain physicians do not want to lose this procedure from our list of available options for our patients with spinal stenosis. Please reconsider your decision on this procedure.
Tune, Adam Date: 11/15/2013
Comment:

I am a pain management Physician board certified in Anesthesiology with a subspecialty in Pain Medicine. I have been practicing medicine for seven years. I am genuinely disappointed with the CMS proposed outcome for the PILD procedure.

While surgical decompression patient series have reported better outcomes than conservative treatment the success is temporary by higher complication rates related to invasive surgery. Decompression surgery as an option is often associated with

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Luh, George Title: MD
Date: 11/15/2013
Comment:
I am an Interventional Neuroradiologist working in a community practice. Our practice has performed approximately 70 percutaneous image-guided lumbar decompression procedures. We have not had any complications at all. Zero. Not because we are special, but because the procedure is inherently safe. We follow all of our patients long term and have collected data using validated outcome measures such as VAS, ODI, ZCQ, SF-12v2. What we are finding is that patients get great pain relief for the

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Wright, Heather Title: CEO
Organization: Ballard Wright, MD, PSC aka The Pain Treatment Center
Date: 11/15/2013
Comment:
I am very disappointed to hear the CMS is proposing to not cover the MILD procedure. As the CEO of a large pain practice in Kentucky, the procedure gave a viable option for treating patients with Lumbar Spinal Stenosis. Although we have just begun performing the procedure, our outcomes were positive. Specifically, two of our patients [PHI Redacted] have reported being able to perform activities that they previously were not able to do, and with lessened pain. Specifically,

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Chowdhury, Tajul Title: M.D.
Organization: Center For Interventional Pain Management
Date: 11/15/2013
Comment:
I have been doing MILD procedure since 2010, most of my patients are older patient age 50+ have been suffering from spinal stenosis with neurogenic claudication to lower extremity. Almost 75% have responded with excellant results. Their actvities of daily living increased tremendously. They have decreased the intake of oral pain medications and increased sleep. They have almost zero complications and it is an Outpatient procedure, lot less invasive and less expensive. At least 50% of these

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Bernardini, Donald J. Title: MD
Organization: Bons Secours Neuroscience Center for Pain Management
Date: 11/15/2013
Comment:

I have performed the MILD Procedure on 30 patients suffering from lumbar spinal stenosis (LSS). Approximately 20 of those patients did not want open lumbar decompression and the remaining patients were not offered surgery due to existing medical comorbidities. Many of my patients did very well follwoing the procedure. All had a quick recovery time and no complications. Nearly all have reported excellent relief of their lower extremity symptoms and have improved functional abilities,

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Butcher, PA-C, Aaron Date: 11/15/2013
Comment:

This letter serves as a consensus statement involving a majority of the board-certified and/or fellowship-trained pain management physicians in the Southern Nevada region. This statement is in regards to the proposed National Coverage Determinations (NCDs) regarding PILD or MILD.

The participants in this statement are in agreement that certain set standards must be implemented within the specialty of Pain Management. However, these national coverage determinations would be

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Burkhead, Daniel Date: 11/15/2013
Comment:

This letter serves as a consensus statement involving a majority of the board-certified and/or fellowship-trained pain management physicians in the Southern Nevada region. This statement is in regards to the proposed National Coverage Determinations (NCDs) regarding PILD or MILD.

The participants in this statement are in agreement that certain set standards must be implemented within the specialty of Pain Management. However, these national coverage determinations would be

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Zubieta, MD, PhD, Jon-Kar Title: Professor
Organization: The University of Michigan
Date: 11/15/2013
Comment:

I would like to comment on the proposed decision memo for the Percutaneous Image-Guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS), which concluded that PILD is not reasonable and necessary. Specifically, I would like to address to what degree the findings of the studies presented to the Board could represent non-specific effects, such as placebo responses, regression to the mean or changes in the natural history of disease. I am a tenured, endowed Professor in Psychiatry

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Chafin, Timothy Brent Title: Medical Director
Organization: Vidant
Date: 11/15/2013
Comment:

I wish to further expand upon my initial posting asking CMS to reconsider its draft decision. I have performed more than 590 MILD procedures over the past 3 years. As an anesthesiologist I am under a great deal of scrutiny by my surgical colleagues. As such, our hospital Medical Executive Committee has been extremely vigilant to verify that this procedure is safe and effective. Patients are randomly selected for questioning at 2 week, 6 week and 6 month intervals post-procedure.

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malinky, chris Title: physician
Organization: interventional pain management
Date: 11/15/2013
Comment:
I would like to express my disappointment with the CMS denial of coverage related to the MILD procedure. My practice has over 3 years of experience with this procedure and has treated nearly a 100 patients with this technique. On average our patients have received a 70% reduction in their symptoms following a Mild procedure. There is a treatment gap for Medicare patients with central canal stenosis between oral meds and epidural injections and a traditional laminectomy. There are many patients

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algendy, sherif Date: 11/15/2013
Comment:
Pain and spine as a speciality is lacking strong double blinded studies in general,Percutaneous lumbar decompression is a low risk procedure that has been very effective in selected patients,the key word is good ptient selection, I think that there should be strict selection criteria and vigorous auditing process to prevent performing the procedure when it is not indicated rather than completely taking the option of performing the procedure from physicians and patients.
Fender, Earl Title: President & CEO
Organization: VertiFlex, Inc.
Date: 11/15/2013
Comment:

Dear Administrator Tavenner,

On behalf of VertiFlex Inc., I am submitting comments in response to the October 17, 2013 publication of the Preliminary Decision Memorandum (CAG #00433N) titled “Percutaneous Image-Guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS).”

VertiFlex Inc. is a medical device company dedicated to the advancement of minimally invasive solutions for the treatment of LSS. We are the developer and manufacturer of the Totalis™

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Eubanks, Kimber Date: 11/15/2013
Comment:

I would hope that the per cutaneous decompression would continue to be reimbursed under CMS. This is the ONLY procedure used for pain management of spinal stenosis that has been effective in our practice. Although I was initially very skeptical of what I perceived as just another new procedure which was "cool", but ineffective, this procedure has been remarkably effective in the proper patient population.

We measured pain and disability indexes prior to, and after, using this

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Klagges, M.D., Brian Title: Director, Interventional Spine Center
Organization: Amoskeag Anesthesia
Date: 11/15/2013
Comment:

I read with great disappointment the draft coverage proposal for percutaneous image guided lumbar decompression.

The medical community has a great tool in percutaneous lumbar decompression to treat thousands of patients who suffer from symptoms of neurogenic claudication secondary to lumbar spinal stenosis. Prior to the advent of mild, patients were left only with epidural steroid injections on one end of the spectrum, and major surgery (laminectomy)on the other end of the

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Bocchino, Carmella Organization: America's Health Insurance Plans
Date: 11/15/2013
Comment:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong

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Vrooman, Bruce Title: Anesthesiologist / Pain Medicine Specialist
Organization: Cleveland Clinic
Date: 11/15/2013
Comment:

I am writing in support of the mild procedure as an anesthesiologist who is fellowship-trained in pain medicine and has performed the mild procedure for properly-selected patients.

As an anesthesiologist, I appreciate how mild may be performed with monitored anesthetic care (MAC) rather than a general anesthetic that is required for highly interventional spinal surgeries such as laminectomies.

As a pain medicine specialist performing the mild procedure, I appreciate

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prince, robert Title: Spine Specialist
Organization: St Francis Spine Specialists
Date: 11/15/2013
Comment:

I am a board certified ABA Pain Management and board certified anesthesiologist who residencey trained at Johns Hopkins, has 30 years of experience, and was recently featured in the Top Docs issue of Indianapolis Magazine. I have publications and patents myself.

The decision to stop coverage of the MILD procedure, percutaneous lumbar decompression, is a terrible mistake. It has been a life changing procedure for many of my patients with symptomatic neurogenic claudication who

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Rupert, Steven A Date: 11/15/2013
Comment:

Dear CMS

I have done about 16 patients using the MILD procedure, which you referr to as the PIGLD. Of those going through the procedure I would 60-70% are able to walk through Walmart again. Those that failed usually have other issues in combination with the spinal stenosis.

There is about 40% of the patients who get 90-100% results giving them complete pain relief. This is a good procedure that prevents major surgery, decreases the cost, is safer for the patient, and

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Syed, Mubin Title: President
Organization: Dayton Interventional Radiology
Date: 11/15/2013
Comment:
Dear CMS

I am an interventional radiologist and neuroradiologist who has been performing the MILD procedure since Aug 2011. I have performed a large number of these procedures. The MILD procedure is helpful in the vast majority of patients who lack many options. It has significantly improved the VAS score and Oswestry Back Pain Disability Index longterm (list actually results) and has remained durable for more than 2 years. Despite CMS’ assertion that there is no clear diagnosis for

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Willoughby, Channing Title: Pain Physician
Organization: Next Step Pain Management
Date: 11/15/2013
Comment:

I am a practicing pain physician in South Carolina with extensive exposure to the MILD procedure. I have utilized this valuable treatment modality to help several patients in my practice over the past 2 years. Just this week, a previous MILD procedure patient returned for follow up, stating he felt the best he had in over 4 years. Numerous patients that have previously underwent the MILD procedure in my office can attest to much of the same. Overall, I have seen approximately 75%

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Roig, Jorge Organization: Weirton Medical Center
Date: 11/15/2013
Comment:

Jorge W Roig, CMS Comment

As an Anesthesiologist and Pain Management Physician it is my professional goal to look past the daily challenges and evolve into the most knowledgeable and conscientious physician that provides excellent patient care. For this reason, I am submitting my utter disappointment with the CMS decision for non-coverage for PILD.

With several appointments and certifications it is important as Physician’s to find the best treatment options available to

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Caraway, MD,PhD, David Title: Executive Vice President
Organization: American Society of Interventional Pain Physicians
Date: 11/15/2013
Comment:

The American Society of Interventional Pain Physicians (ASIPP) welcomes the opportunity to comment on the draft National Coverage Analysis (NCA) for Percutaneous Image-Guided Lumbar Decompression (mild) for Lumbar Spinal Stenosis (LSS). According to the NCA comment posted by Vertos Medical on May 5, 2013 over 90% of physicians using the mild procedure are Interventional Pain Physicians so we feel compelled to provide CMS with the perspective of the treating physician on this decision.

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Le, Brian Title: Interventional Pain Physician
Organization: Las Vegas Spine & Pain Center
Date: 11/14/2013
Comment:

I am a board-certified and fellowship-trained pain management physicians in the Southern Nevada region. This statement is in regards to the proposed National Coverage Determinations (NCDs) regarding PILD or MILD.

I agree that certain set standards must be implemented within the specialty of Pain Management. However, these national coverage determinations would be unreasonably restrictive of the ability of a pain management physician to provide meaningful improvement in the

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soin, amol Date: 11/14/2013
Comment:

As the President and Vice President of the Ohio Society of Interventional Pain Physicians (OSIPP), we would like to respond to the negative CMS draft policy for national coverage of PILD or mild. OSIPP was formed in 2000 with the goal of promoting the development and practice of safe, high quality yet cost effective interventional pain management techniques for the diagnosis and treatment of pain and related disorders, and to ensure patient access to these interventions. In order to

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Huntley, Michael Date: 11/14/2013
Comment:

I am a pain management Physician, Diplomate of the American Board of Anesthesiology and certified in the subspecialty of Pain Medicine. I have been practicing medicine since 1986 and performed well over 40 PILD procedures. I am writing to express my discontent regarding the CMS proposal for non-coverage of the PILD procedure.

CMS explains its decision for non-coverage in reviewing the evidence on PILD were confronted with weak studies, questions about missing information,

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Staats, Peter Organization: Premier Pain Centers
Date: 11/14/2013
Comment:

I would like to urge you to reconsider your draft NCA proposal and issue a final positive national coverage determination. I gave a thorough analysis of the available data in my comment posted on April 29, 2013 and I would like to reaffirm my conviction in the strength of the evidence available on the mild procedure. I agree with the large number of my interventional pain physician colleagues who have posted comments when they state that this procedure fits a critical unmet need in the

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Rosenberg, MD, Jason Title: President
Organization: SC Pain and Spine Specialists
Date: 11/14/2013
Comment:

Jason Rosenberg MD

I am a board certified physician in Neurology and completed a one year interventional Pain Management fellowship at Wake Forest University leading to board certification in Pain Management.

I am writing comments to support the PILD procedure.

After reading the feedback from CMS, I have pointed comments and concerns:

With regard to diagnosis of “back pain” – this is not clear cut. The PILD procedure treats symptomatic neurogenic

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Attias, Miguel Title: MD
Organization: Tampa Pain Relief Center
Date: 11/14/2013
Comment:

As an interventional pain specialist I have had the opportunity to treat several patients with the Percutaneous Image-guided Lumbar Decompression (MILD PROCEDURE) and I am very disappointed to hear about the recent CMS coverage determination. For the patients I selected (following the recommended criteria) the patient outcomes were excellent with no complications or associated morbidity, in my practice approximately 80% of these patients now have a better functional capacity,

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Chen, Hsiupei Title: MD
Organization: Carolina Pain Consultants, a division of AANC
Date: 11/14/2013
Comment:
I am a pain physician with Carolina Pain Consultants. I have been treating patients with spinal stenosis for the past 9 years, and the minimally invasive lumbar decompression device is the first exciting new technology that I have come across during that time. Considering the comorbidities of the elderly population afflicted with this disease, and the paucity of complications, the MILD procedure can often be preferable to spinal decompression surgery. There is also mounting evidence that

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AASEN, MARK Date: 11/14/2013
Comment:

I am disappointed and bewildered by the CMS proposal that PILD for LSS in not reasonable and medically necessary and should not be covered by Medicare.

I have been practicing Interventional Pain medicine for almost 20 years. I have done 26 PILD cases. I have found that, in carefully selected patients, PILD is both safe and effective for people with symptomatic central spinal stenosis.

I have also cared for patients who have undergone traditional open surgical approaches

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rentz, jack Title: MD Physician
Organization: Rocky Mountain Pain Solutions
Date: 11/14/2013
Comment:

Jack Rentz, M.D. comment in favor of coverage.

I am Pain Management Physician having just begun to perform the mild (PILD) procedure in 2013. It is the only conservative options for patients with Spinal Stenosis with neurogenic claudication. I firmly believe CMS’ decision to propose non-coverage for this procedure is a grave loss to Medicare beneficiary’s as well as the treating Physician community.

Having a significant patient population of Medicare beneficiary’s is

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Firnhaber, Juan Title: Clinical Professor. Attending Physicians
Organization: East Carolina University. East Carolina Pain Consultants
Date: 11/14/2013
Comment:

As a Pain Medicine physician I have treated patients with lumbar spinal stenosis for the last 10 years, a significant number of patients are not candidate for surgery and are treated with more conservative treatment such as PT, medications and also minimal intervention such as epidural steroid injection, although this are very helpful in some patients, there are patients where these procedures or other conservative treatment do not give significant or long rem relief.

These

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Kowal, Andrew Title: Director, Pain Management
Organization: Lahey Hospital & Medical Center
Date: 11/14/2013
Comment:

As a pain managemnent physican with 20 years experience and always a skeptic of new, expensive technologies that tend to be over-utilized by many for "pain management" I had to comment on the PILD issue. In an era when our nation is in a crisis of opioid abuse and over-prescribing and as our population ages we will need all tools necesaary to treat Lumbar Stenosis pain and dysfunction. The mild procedure is effective in well selected patients and allows us an alternative to narcoctic or an

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Lipman, Zachary Title: MD/Medical director
Organization: Interventional Pain Solutions
Date: 11/14/2013
Comment:
I have performed about 20 MILD cases on patients with Lumbar spinal stenosis, ligamentum flavum infolding and neurogenic claudication and I have to say that most of these patients have had favorable outcomes and are able to stand/walk for longer than before the procedure. These patients are extremely happy with the outcomes. I have not seen any complications such as worsening symptoms after the procedure. This procedure must be approved by CMS because it offers a solution to these patients

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Webster, MD, Lynn R. Title: President
Organization: The American Academy of Pain Medicine (AAPM)
Date: 11/14/2013
Comment:

November 14, 2013

Louis Jacques, M.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
7500 Security Blvd.
Mailstop S3-02-01
Baltimore, MD 21244

Re: National Coverage Analysis (NCA) for Percutaneous Image-Guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (CAG-00433N)

Dear Dr. Jacques:

The American Academy of Pain Medicine (AAPM) is the primary

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Muir, Jeffery Title: Physician
Organization: Spine & Sports of Summerlin
Date: 11/13/2013
Comment:

This statement is in regards to the proposed National Coverage Determinations (NCDs) regarding PILD or MILD. I strongly suggest a positive National Coverage Determination for PILD,or MILD.

I agree that certain set standards must be implemented within the specialty of Pain Management. However, these national coverage determinations would be unreasonably restrictive of the ability of a pain management physician to provide meaningful improvement in the life of a Medicare

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Parker, MD, Edson Title: Director, Interventional Pain Medicine
Organization: Veterans' Administration Medical Center, Las Vegas, NV
Date: 11/13/2013
Comment:
The PILD (or MILD) procedure is one of most useful procedures to be created in the past decade. I am a physician and perform the procedure. It allows me to treat patients definitively for symptomatic lumbar spinal stenosis without the patient having to received general anesthesia or have a more invasive laminectomy procedure, both of which have more risk than the PILD (MILD) procedure. Thus, many older and/or sicker patients who cannot have a laminectomy can still have their spinal stenosis

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Benyamin, Ramsin Title: President
Organization: Millennium Pain Center- Illinois
Date: 11/13/2013
Comment:

I wish to thank you for the opportunity to comment on the draft national policy on PILD. As the Past-President of the American and Illinois Society of Interventional Pain Physicians and the President-Elect of the American Society of Interventional Pain Physicians, I respectfully disagree with the negative proposed national coverage decision for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (PILD or mild). In addition to more than one hundred thirty public

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Stewart, MD, Brent Date: 11/13/2013
Comment:

I SUPPORT the use of percutaneous image-guided lumbar decompression for lumbar spinal stenosis. This is an effective therapy.

- spinal stenosis related to ligamentum flavum hypertrophy is relatively straightforward to diagnose; decompressing the ligament is far easier on the patient than surgically removing a lamina
- it is minimally invasive with a very short recovery
- in properly selected patients, it has a very high success rate, which markedly reduces the costs

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Knox, Thomas Title: President
Organization: Integrative Pain Management
Date: 11/13/2013
Comment:

Please do not deny coverage of this remarkable procedure. Nothing in medicine is a 100% success and this procedure is no exception. What makes it exceptional is the simplicity, the safety and the efficacy. I have been performing this procedure for over 2 years and have performed the procedure on nearly 50 patients. This procedure has allowed people who could not walk from their kitchen to the bath or stand and cook dinner or do dishes recapture their life. I am not a researcher, but I

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Brown, Robert Title: Consultant in Pain Mangement
Organization: Rocky Mountain Pain Solutions
Date: 11/13/2013
Comment:

I am a Diplomate of the National Board of Medical Examiners, Board Certified by the American Board of Anesthesiology, American Board of Anesthesiology with subspecialty Board Certified in Pain Medicine, and the American Academy of Pain Medicine. I have been practicing pain medicine for 25 years. I am writing as to my concerns of the non-coverage proposal from CMS for the MILD procedure.

CMS concludes that based on review there is a lack of consensus of the definition of spinal

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Fotopoulos, M.D., C. Lan Title: Interventional Spine & Sports Medicine
Organization: Dickson-Diveley Midwest Orthopaedic Clinic
Date: 11/13/2013
Comment:

Constantine Lan Fotopoulos – CMS Comment

I am board certified in Physical Medicine and Rehabilitation, Pain Medicine, Undersea and Hyperbaric Medicine, and Sports Medicine. I have been performing the PILD procedure for over two years. I appreciate the opportunity to express my concerns with regards to the proposed decision from CMS for non-coverage. In light of my successful experience with the treating patients with the PILD procedure, I am requesting the CMS reevaluate its’

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Evans, MD, William Martin Title: MD, Medical Director, SEPC, Blueridge Healthcare
Organization: Southeast Pain Care
Date: 11/13/2013
Comment:
I am the medical director of Southeast Pain Care with Blueridge Healthcare in western NC. I have been following the development of the MILD procedure for the last few years and have recently become credentialled in performing the procedure. I am confused and disturbed by the recent decision by CMS to withhold reimbursement for this procedure. The studies are very positive, the complication rate is very low, and many of these patients have no other good options for treatment of spinal

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Krafft, Ryan Title: Double Board Certified in Pain Management and PMR
Date: 11/13/2013
Comment:

Although my experience may not be as extensive as many of other practitioners commenting, my outcomes thus far have been quite profound and I would disagree with any movement toward not supporting the continued use of minimally invasive lumbar decompression. I have participated in greater than 30 minimally invasive lumbar decompression or 'mild' cases through fellowship and in private practice with a large percentage of them substantially improving, and have yet to see a patient worse off

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shrestha, ajit Title: M.D.
Organization: SUSSEX PAIN RELIEF CENTER
Date: 11/13/2013
Comment:
I believe this procedure has very good role in alleviating chronic back and leg pain in select group of patients with ligamentum flavum hypertrophy contributing to significant spinal canal stenosis. I think it will help some of these patients to avoid extensive back surgery and to lead a meaningful life.
Netherton, Mark Title: Dr.
Organization: Southeastern Spine Institute
Date: 11/13/2013
Comment:
I have performed MILD procedures for the past four years. My results with this procedure have been excellent. Obviously the results have not been 100%, but much better than epidurals or open procedures and the post op course. Obviously I was suprised with the decision to not cover this effective minimally invasive procedure. I understand there is no good consensus on stenonis criteria, but do think clinical exam, symptoms, and radiologic evidence is important. We obviously need better outcome

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shah, bharat Title: M.D.
Organization: Comprehensive pain care center and Lorain Surgery center.
Date: 11/12/2013
Comment:

I am an interventional pain management physician for more than 20 years. I have treated many patients with lumbar spinal stenosis.These patient are very limited to what they can do because their spinal stenosis. Many of these patients are old and have many other co-morbid medical conditions and are not good candidate for invasive spinal surgery . MILD procedure is one of the best option they have. Outcome of this procedure is very successful and has been shown in many studies all across

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Bassam, Deeni Title: Interventional Pain Management
Organization: The Spine Care Center
Date: 11/12/2013
Comment:

This would be the wrong decision for medicare patients. As a physician who works in a multi-specialty practice dedicated to the treatment of spinal disorders I can tell you that you will be taking away a significant, unique, and meaningful option for medicare patients suffering from spinal stenosis. I have performed over 50 MILD procedures over the past 18 months and I can say without reservation that if I were unlucky enough to suffer from severe spinal stenosis I would most certainly

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Anderson, Anthony Date: 11/12/2013
Comment:

I would like to take this opportunity to respond to the proposed decision memo for the Percutaneous Image-Guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS), which concluded that PILD is not reasonable and necessary. I am a board certified anesthesiologist and pain management physician licensed in Missouri and Illinois. I have over 25 years of experience in treating pain patients following a comprehensive fellowship training at Johns Hopkins University Hospital. I was

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Verdolin, Michael Title: Medical Director
Organization: Verdolin Pain Specialists
Date: 11/12/2013
Comment:

It is with dismay and significant disappointment I read the draft decision on PILD. I have been performing this procedure since March 2010. As an interventional pain management physician, I see many patients with debilitating spine disease. Equally so, I see many patients who have failed large spinal operations, including open laminectomy and instrumentation with fusion. Interestingly, a very large study performed by the surgery community with respect to open laminectomy demonstrated very

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James, MD, William Date: 11/12/2013
Comment:
Percutaneous Image-guided Lumbar decompression for spinal stenosis (MILD) is an effective, low risk and useful tool for treating patients with central stenosis when a contributing factor is ligamentum flavum hypertrophy. Key, of course, is proper patient selection. In our practice we have utilized MILD with very good results and high patient satisfaction without a single complication. This is a valuable option for patients suffering from stenosis and in properly selected patients preferable

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Wahezi, Sayed Emal Title: Asst. Program Director, Pain Medicine Fellowship
Organization: Montefiore Medical Center/Albert Einstein College of Medicine
Date: 11/12/2013
Comment:

Below are my comments in response to the draft decision memo to suspend PILD reimbursement. There were several points included in the analysis that aren’t factual and/or I do not agree with. I believe strongly that PILD should be available as a treatment option for Medicare beneficiaries suffering from lumbar spinal stenosis with neurogenic claudication.

Point 1: “A lack of consensus on diagnostic criteria for LSS: There are many conditions that lead to back pain so it is hard to

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kosek, peter Title: MD
Organization: Pain Consultants of Oregon
Date: 11/12/2013
Comment:

Image guided lumbar decompression has a critical place in the care of elderly patients with spinal stenosis who are poor surgical candidates for open decompression. Many elderly patients with heart and lung disease suffer significant morbidity from laminectomy as demonstrated in the SPORT trial. Multiple studies have demonstrated both the safety and efficacy of this therapy in exactly this population.

Image guided decompression also represents a significant cost savings over

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Hoelzer M.D., Bryan Title: Department of Anesthesiology - Fellowship Director
Organization: Mayo Clinic
Date: 11/12/2013
Comment:

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

Re: Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N)

Dear Dr. Jacques:

Mayo Clinic appreciates the opportunity to share our comments on the Centers for Medicare & Medicaid Services (CMS) proposed decision memo for

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Gonzalez-Cota, Alan Title: Staff Physician, Pain Medicine Department
Organization: Beebe Healthcare
Date: 11/12/2013
Comment:
Commenter: Gonzalez-Cota, Alan
Organization: Delaware Society of Interventional Pain Physicians

November 11, 2013

Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
7500 Security Blvd.
Mailstop S3-02-01
Baltimore, MD 21244

As President-elect for the Delaware Society of Interventional Pain Physicians (DSIPP) would like to comment on the recent national coverage analysis (NCA)decision on the Percutaneous

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Birthi, Pravardhan Organization: Saint Francis Medical center
Date: 11/12/2013
Comment:
I have doing minimally invasive lumbar decompression on patients who have clinical diagnosis of neurogenic cluadication which is confirmed by imaging who are not candidate for surgical intervention due to age and other contraindication. My patient are having great benefits and able to ADLs with out any pain. I have not had any complication after surgery.Based on efficacey,low risk profile and low cost I would hope CMS would reconsider there draft proposal and make the MILD procedure avialble

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Aner, Musa Title: Attending Physician
Organization: Beth Israel Deaconess Medical Center
Date: 11/12/2013
Comment:

Minimally invasive lumbar decompression (mild) is designed and has been serving a distinct segment of patients with spinal stenosis who are otherwise not helped with injections or not candidates for surgical intervention. This procedure has created a functional improvement opportunity for this particular segment of patients.

Working in an academic environment, we have reviewed the existing data that shows favorable outcomes for the appropriately selected patients. When proficiently

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Grider, Jay Date: 11/12/2013
Comment:

I would like to offer a comment on CMS’s proposed decision to not cover the mild procedure. I believe this decision is an incorrect evaluation of the available data. Many of my colleagues have already posted comments expressing how this therapy serves an important role of treating patients who have failed conservative therapies but who are not surgical candidates due to health issues and age. These patients have no viable options and this decision by CMS takes away one of the more

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Raso, Louis Date: 11/12/2013
Comment:

November 12, 2013

Dear Sirs:

I strongly disagree with the initial draft policy for Percutaneous Image-guided Lumbar Decompression (PILD or MILD) for Lumbar Spinal Stenosis. The treatment has been widely adopted across the country, and the demand for an outpatient, minimally invasive option for lumbar spinal stenosis (LSS) patients is high. MILD fills an important void in the treatment algorithm, providing patients a choice between palliative conservative treatments and

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Datta, Samyadev Title: Director
Organization: Center for Pain Management
Date: 11/12/2013
Comment:

As a Board Certified Pain Specialist and a Board Certified Anesthesiologist, as well as a Fellow of the Royal College of Anaesthesiology of England, I have been performing minimally invasive lumbar decompression over the last 22 months and have performed about 120 cases. I have been very satisfied with the outcomes in these cases. The results have been about 80-85% positive outcome, without any complications.

Of all the patients, 3 have needed surgery as they did not respond to the

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Tonkin,M.D., David Date: 11/11/2013
Comment:
I have personally performed many MILD procedures with "significant" improvement of each patient's ability to stand upright and ambulate for a substantial increased amount of time. Properly trained, these procedures are safe and allow patients to undergo treatment for neurogenic claudication in a minimally invasive manner and under minimal sedation. I encourage CMS to reconsider approving reimbursement for this beneficial procedure.
Sinotte, Lisa Marie Title: RN
Organization: Elliot Hospital
Date: 11/11/2013
Comment:
I was disappointed to hear that the MILD procedure would not be covered for medicare patients next year. I work with a doctor that started the procedure at our hospital and have seen many satisfied patients that literally leave our outpatient clinic standing straighter and having less pain. This procedure is a proactive approach to treating back pain. It is a cost effective approach. This prevents patients from having a long hospital stay and high medical bills from surgery and an inpatient

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Wilson, Robert Title: Medical Director
Organization: Piedmont Interventional Pain Care
Date: 11/11/2013
Comment:

I am responding to the Centers for Medicare and Medicaid Services (CMS) draft coverage regarding the Percutaneous Image-Guided Lumbar Decompression (PILD) released on October 17, 2013. The draft that you released indicated that there was insufficient evidence proving the PILD procedure was reasonable and necessary for coverage by CMS. What I find ironic is this is the same CMS that in November of 2012 allowed Certified Registered Nurse Anesthetists (CRNAs) to be allowed to perform, bill and

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Voscopoulos, Christopher Title: Division Chief and Director of Pain Management
Organization: Norwood Hospital, Steward Healthcare
Date: 11/11/2013
Comment:

I have performed this procedure on two patients having recently learned the technique. I have several more patients awaiting this procedure if Medicare will continue to cover it. Both of the two patients I performed the MILD on have done exceptionally well (1 patient with no further pain and dramatically increase walking and standing ability, with the other having a 80% decrease in pain and dramatic walking and standing ability). There where absolutely no complications and recovery time is

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Hill, Catherine Date: 11/11/2013
Comment:

On behalf of the American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), and the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves, we appreciate the opportunity to comment on the National Coverage Analysis (NCA) for Percutaneous Image-Guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS). We agree with the proposed decision not to cover the procedure.

Although some Neurosurgeons have been trained in

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Mekhail, MD, PhD., Nagy Title: Director, Evidence based Pain Management Research
Organization: Cleveland Clinic
Date: 11/11/2013
Comment:

We conducted a health economics study, looking at the cost of quality adjusted life year (QALY) between three stategies to treat neurogenic claudication secondary to lumbar spinal stenosis.Two years follow up data and beyond showed that the minimally invasive lumbar decompression(mild) is superior to both lumbar laminectomy surgery and repeated epidural steroid injections (ESI).

Full paper as well as the acceptance letter are e-mailed to "mailto:CAGinquiries@cms.hhs.gov"

In

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Fitch, M.D., Jane CK Title: President
Organization: American Society of Anesthesiologists
Date: 11/11/2013
Comment:

November 11, 2013

Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD, 21244

Re: CAG-00433N: Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis

To Whom It May Concern:

The American Society of Anesthesiologists (ASA) appreciates the opportunity to comment on the Center for Medicare and Medicaid Services (CMS) proposed decision to consider percutaneous image-guide lumbar

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Arber, Anatol Date: 11/10/2013
Comment:

THERE ARE 2 TYPES OF THE SPINAL STENOSIS: CENTRAL, CAUSED BY THICKENING OF LIGAMENTUM FLAVUM AS A RESULT EITHER WEAR AND TEAR OF THE LIGAMENTUM AND IT'S ATTACHMENT TO THE BONES DURING LIFE TIME, THICKENING OF THE LIG. IN THE CONDITION LIKE SPONDYLOLISTHESIS AS A MECHANISM FOR REINFORCEMENT AND STABILITY OF THE SPINE, AND DUE TO VARIOUS CHEMICAL REACTION AND IRRITATION, AND LATERAL STENOSIS FROM THICKENING OF THE JOINT CAPSULE IN IT ANTERIOR PORTION ON ONE SIDE AND DISC PROTRUSION ON

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Afzal, Ashar Title: Medical Director
Organization: Cedar Valley Medical Specialsts
Date: 11/10/2013
Comment:

It is disappointing to know that CMS is considering to reverse it coverage for the above mentioned procedure. Comments posted here reflect my experinece as a pain medicine physician practicing more than ten years and providing services in all facets of such including conservative modalities.

Spinal stenosis and Neurogenic caludication is very frequently encountered im my practice and probably one of the most common reasons for a visit to the pain maedicine clinic especially in

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Grudinskas sr, Benjamin J. Date: 11/09/2013
Comment:

I am extending my support for the MILD procedure for Lumbar Spinal Stenosis.

[PHI Redacted]

MILD is the face of the future for relief from this type of problem . In this type of situation, open surgery is archaic, costly, possibly dangerous to the patient, and un-necessary.
Please re-consider the decision to stop funding this operation after 1-15-14.
Brown, Lora Title: Physician/Owner
Organization: TruWell
Date: 11/09/2013
Comment:

Dear Sir/Madam,

I would like to take this opportunity to address the concerns expressed by the NCA about my double-blind, randomized, prospective study of epidural steroid injection (ESI) versus the mild procedure in patients with symptomatic lumbar spinal stenosis (LSS). I served as the sponsor investigator of this study that was approved by an institutional review board and registered on www.clinicaltrials.gov. The study population consisted of symptomatic LSS patients with

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Haladjian, Razmig Title: Medical Director
Organization: Michigan Interventional Pain Center
Date: 11/09/2013
Comment:

It is with a great surprise and disappointment that I came to find out about CMS coverage proposal for PILD.
I am a fellowship trained Interventional pain physician. I have been doing PILDs for around 5 years and have performed around 350 cases to date. What I have to say about PILD for spinal stenosis comes from first hand observation of outcomes.

I want to start by saying that PILD for spinal stenosis is effective. I had doubts about it when I first started doing them but I

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Erlendson, MD, Lee Title: Medical Director
Organization: Rancho Mirage Pain Center
Date: 11/09/2013
Comment:

Percutaneous Image-guided Lumbar Decompression for certain forms of severe lumbar spinal stenosis is a critical and important tool for Physicians and Surgeons to enable severely diabled patients who have multifactorial lumbar spinal stenosis. Many of these patients cannot undergo major lumbar spine surgery to correct their disabling spinal stenosis. They are high risk for such procedures. Major surgical decompression results in much higher rates of major complications such as bleeding,

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Aydin, Steve Title: D.O.
Organization: Manhattan Spine and Pain.
Date: 11/09/2013
Comment:

In a climate of medical change, and a population that is aging and remaining functional, this can only make sense. To place these patients in the hands of only surgical options, and no other symptomatic relief is risky. Surgery has a high complication rate, and is extremely more taxing on society, the patient, and medical system.

A procedure that may be less invasive than a complex surgery and prolonged hospital stays, needs to be considered. This procedure has offered several

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Paicius, Richard Title: Physician
Organization: Newport Beach Headache & Pain
Date: 11/08/2013
Comment:

I am a Diplomate of the American Academy of Pain Medicine, American Academy of Pain Management, and American Board of Anesthesiology with Extended Qualification in Pain Management.I would like to express my dissatisfaction with the CMS decision of non-coverage for the PILD procedure.

It seems clear that CMS based its decision for non-coverage on anything other than the clinical facts; patients are experiencing favorable outcomes post-operatively. One patent in particular comes to

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Poree, Lawrence Title: Associate Professor-Department of Anesthesia
Organization: University of California at San Francisco
Date: 11/08/2013
Comment:

I am writing in support of Percutaneous Image-guided Lumbar Decompression (PILD) for the treatment of lumbar spinal stenosis as a reasonable and necessary procedure that should be covered by Medicare.

PILD is not a procedure that is used for ill-defined back pain. Instead it is a procedure that is appropriate for patients that meet very specific diagnostic criteria including buttock and leg pain with standing for less than 5 minutes, walking erect for less than 100 yards with

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Baylor, Monty Date: 11/08/2013
Comment:

I am a private practice pain management physician with 20 years experience and have performed many of these procedures my patients who had neurogenic claudication secondary to ligamentum flavum hypertrophy and lumbar spinal stenosis. The results were excellent and patients were able to improve there ability to walk and reduce painful neurogenic claudication.There is not a comparable treatment. The Institute of Medicine stated that "relieiving pain should be a national priority". Presently,

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Golovac MD, Stanley Date: 11/08/2013
Comment:

I am a board certified Anesthesiology and Pain Management physician with almost 30 years of experience. I have personally performed almost 100 mild procedures and can attest to the excellent results I have achieved in my patient population. I disagree with the National Coverage Analysis recommendation for non-coverage. In reviewing the CMS Proposed Decision for coverage of PILD, it appears that a primary concern is the ability to have a consensus on treatment and diagnosis of LSS. CMS has

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Johnson, Vance Title: Director
Organization: University Spine Institute
Date: 11/07/2013
Comment:

Thank you for the opportunity to provide a comment on the proposed decision memo for PILD (Percutaneous Image-Guided Lumbar Decompression). I have been performing PILD, or MILD, for over three years and have treated close to 150 patients.

I disagree with the proposed decision memo and would like to address a couple of the main concerns presented in CMS’ draft analysis:

The draft states that CMS is, “concerned that the lack of consensus on the definition of spinal

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Rhodes, Larry Date: 11/07/2013
Comment:

This procedure is GREAT. [PHI Redacted] This procedure is minimally invasive which means no hospitalization. It can be repeated if necessary without incurring excessive and debilitating recovery time. To deprive people of this medical procedure would be criminal when it it so helpful and does not require prolonged recovery periods and hospitalization. The only people who gain from not covering this procedure are the thousands of doctors and hospitals who will lose

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Adkins, RN, Carol Title: RN
Organization: Center for Pain Management
Date: 11/07/2013
Comment:

My name is Carol Atkins. I am a registered nurse working at the Center for Pain Management in Hackensack New Jersey. In the last 2 years we have treated many patients with severe spinal stenosis. We have been able to perform about 100 minimally invasive lumbar decompression procedures.

To me it has been a great joy to see how many of these patients have had significant reduction in the pain and it has helped them. It has made a significant improvement in there quality of life

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Witt, MD, William Title: Medical Director, Professor and Chairman Emeritus
Organization: Cardinal Hill Rehabilition Hospital
Date: 11/07/2013
Comment:

I am writing to express my concern at CMS’s proposal to not cover MILD. I believe that this decision does not accurately reflect what is known about the mild therapy both in “real world” practice and the clinical data. I would like to specifically address some of the concerns in the NCA that served as the foundation for the decision. The NCA made frequent mention of the placebo effect, regression to the mean, and other biases. Whereas these concerns may be understandable on initial

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Hayek, Salim Title: Professor, Dept of Anesth; Chief, Pain Medicine
Organization: University Hospitals, Case Western Reserve University
Date: 11/07/2013
Comment:
the mild procedure fulfills a small niche for treatment of lumbar canal stenosis, albeit an important one. Patients with a central canal stenosis that is isolated to one or 2 levels without significant foraminal stenosis are optimal candidate for this procedure.the procedure acts as a bridge between this and the invasive intervention such as injections and more invasive interventions such as lumbar spine surgeries. It is a relatively simple procedure performed that can produce major

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Annello, Patrick Title: Director Interventional Pain Management
Date: 11/07/2013
Comment:

I am a Board Certified Anesthesiologist and Pain Management physician at St. Francis Hospital in Roslyn, NY. I have treated over 60 patients with the mild procedure. I do not agree with the draft National Coverage Determination on the mild procedure and believe it would be a disservice to Medicare patients to deny them this important treatment option.

Mild is a minimally invasive procedure that provides a treatment option for a subset of patients with lumbar spinal stenosis

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Wong, Wade Title: Emeritus Professor of Radiology
Organization: whwong@ucsd.edu
Date: 11/07/2013
Comment:

I am a Board Certified physician in Diagnostic Radiology/Interventional Neuroradiology and also a Board Certified Physician in Pain Medicine with over 40 years of practicing medicine. I have been a firm proponent of the mild procedure since 2009. Since the start of implementing the PILD procedure into our facility, University of California, San Diego and its affiliate the San Diego VA Medical Center; we have completed over 40 procedures, with very positive outcomes. We have published

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Naveira, Francisco Title: Medical Director
Organization: NC Pain Management Services PA
Date: 11/07/2013
Comment:

For those of us that have referred patients to be successfully treated by the MILD procedure when the Orthopedic Surgeons and Neurosurgeons have refused to treat them based on their age and medical risk factors for undergoing general anesthesia, there is no other alternative treatments. To state otherwise is not to be in touch with clinical reality. There is no question that as with all other medical modalities, it is imperative that we continue collecting data and refining the guidelines,

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Lingreen, Richard Title: Physcian/Owner
Organization: Commonwealth Pain Specialists, PLLC
Date: 11/06/2013
Comment:

I am a mild treating physician with Board Certification with the American Board of Anesthesiology, American Board of Anesthesiology with Subspecialty Certification in Pain Medicine, American Board of Pain Medicine, American Academy of Pain Management, and American Board of Addiction Medicine. I have performed over 400 mild procedures and co-authored a publication titled “Retrospective Review of Patient Self-Reported Improvement and Post-Procedure Findings for mild (minimally invasive lumbar

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MALIK, TARIQ Organization: University of Chicago Hospitals
Date: 11/06/2013
Comment:
Its an important procedure for select few patients who really meet the necessary criteria. Even though there are no true randomized controlled studies to prove its effectiveness, the physiological approach of the procedure to the problem of spinal stenosis is unquestionably scientific. If the procedure is withdrawn the last hope of pain relief for such patients will be lost. All the cases I have done so far have resulted in at least 50% improvement in walking ability post procedure.
Thomas, Joey Title: physician
Organization: Roanoke Valley pain Center
Date: 11/06/2013
Comment:

Great results from minimally invasive lumbar spine decompression. I have done 25 cases this year, for patients impaired by spinal stenosis with neurogenic claudication. About 70 % experienced excellent benefit, with doubling of their standing time and walking distance. Many have been able to stop taking their pain medications. T date , I haven't had any complications, whatsoever. Most had complete relief of leg pains. Majority of these patients were considered surgically not feasible

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Deer, M.D., Timothy R. Title: President and CEO
Organization: The Center for Pain Relief, Inc.
Date: 11/06/2013
Comment:

As a practicing physician for over 23 years, and an early adopter of this new technology (PILD), I am shocked that CMS would consider denying coverage for this safe and effective LSS procedure, while covering highly-invasive LSS procedures that CMS has not held to the same evidence standard. After treating over 80 patients in the last four years, I have first-hand knowledge of PILD and its exceptionally positive effect on treatment for LSS patients, as well as healthcare costs.

In

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McKenna, Michael Title: Medical Director
Organization: Mckenna, Ruggeroli and Helmi Pain Specialists
Date: 11/06/2013
Comment:

I am a pain medicine specialist. I have performed 37 MILD (minimally invasive lumbar decompression) procedures, resulting in approximately 50% of patients (17) with complete or near complete resolution of their neuroclaudication symptoms. This represents the single most effective treatment I offer. I have had NO complications and those patients that do not improve have the option to continue with a nonsurgical care plan (injections, medications, therapy) or may opt for open decompression

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McKeag, Burt Date: 11/06/2013
Comment:

To whom it may concern,

I have been performing the MILD procedure for the past 2 years. I have never had a complication related to this procedure. All of my patients have had good symptomatic pain relief. For most of my patients the duration has been more than a year. Prior to the MILD they were generally being treated with LESI's every 3 months. These patients either refused surgery or were not candidates for spine surgery due to coexisting morbidity. In my opinion this

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Kabbara, M.D., Abdallah Title: Medical Director, Division of Pain Mediicine
Organization: University Hospitals - St. John Medical Center
Date: 11/06/2013
Comment:
I have been doing the mild procedure for selected patients for spinal stenosis for the last year with very good results. When I evaluate any new technique I look at efficacy , safety and cost effectiveness . I believe that this procedure has established an excellent record track for safety and efficacy in patient with spinal stenosis know to have Ligamentum flavum hypertrophy.It is improving quality of life for a population of patient that either surgical solution is not an option , too risky

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Shrimanker, Nevin Title: MD
Organization: Carolina Pain Consultants
Date: 11/06/2013
Comment:

The PILD procedure has been of great benefit to my patients this past year that suffer from spinal stenosis. These patients have TRUE radiographic imaging studies that indicate their pain generators and the PILD can be of great benefit to them.

Right now, the only treatment afforded them to help with their pain symptoms are invasive surigical procedures that are very painful, require prolonged hospitalizations and post hospitalization costs (ie. rehab, post operative infections,

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Sheehan, Daniel Organization: Palmetto Bone and Joint
Date: 11/05/2013
Comment:
I have treated 15 patients with Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis with excellent results. This is a reasonable and medically necessary procedure for select patients. These patients, for various reasons, are not candidates for major spine surgery and they have failed conservative treatments such as exercise, medications and spine injections.
If this procedure is not available, patients will have less treatment options. Potentially, patients and

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Suthar, Bhavin Date: 11/05/2013
Comment:
Greetings. I am a fellowship trained, board certified pain management physician.
I have experience with the MILD procedure while working in conjunction with an orthopaedic spine surgeon. In any treatment continuum there are valid steps beginning with no intervention to open surgery. MILD fulfills a material unmet "need" in LSS patient care for patients that are not candidates for open surgery due to comorbidities, and satisfies an unmet "want" with a low cost, high quality non-surgical

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Yakovlev, Alexander Title: Medical Director
Organization: Comprehensive Pain Management of FV
Date: 11/05/2013
Comment:

I have performed 7 MILD cases to date. I began performing the procedure 2/27/13. All 7 of these patients have been followed closely as I implemented this. All patients have had outstanding results. Patient selection is very important. The patients selected opted not to undergo a more invasive surgery with a longer recovery period. All these patients have stopped opioid use and they have improved function. Walking times went from 2-3 minutes pre-procedure to 10-15+ minutes.

I

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Chopko, Bohdan Title: Neurourgeon
Organization: Stanford University
Date: 11/05/2013
Comment:

I am a Neurosurgeon and a former Medical Director at MedCentral Health Systems in Mansfield Ohio. I am currently an Associate Professor of the Department of Neurosurgery at Stanford University in Henderson, NV and have been board certified by the American Board of Neurological Surgery since 2005. Thank you for the opportunity to address the CMS proposed non-coverage decision for the PILD procedure, in an effort to bring to light many important concerns with this

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Laub, Ronald Title: Physician:Interventional Pain Mgmt of Colo Springs
Organization: Interventional Pain Management of Colorado Springs
Date: 11/04/2013
Comment:

Ronald M. Laub, MD
Interventional Pain Management
3010 N. Circle Dr. #202
Colorado Springs, CO 80909

November 4, 2013
To CMS via email link:

To Whom It May Concern:

I have been practicing Interventional Pain Medicine and Surgery (full time) since 1992. I have an independent practice in this specialty in Colorado Springs since 2000. I have performed over 80 MILD procedures since the procedure became available (see below).

I was

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Dunteman, Edwin Date: 11/04/2013
Comment:

There are several issues that have been raised regarding her concerns raised a percutaneous image guided lumbar decompression of spinal stenosis. Each of these should be addressed.

#1 A lack of consensus on diagnostic criteria for lumbar spinal stenosis. In actuality, anatomical stenosis can be clearly defined with MRI or CT imaging. While multiple admissions lead to back pain, spinal stenosis given anatomical and physical exam, based diagnosis. The cross-sectional area of the

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Budnick, Linda Title: RN Practice Administrator
Organization: Interventional Pain Management
Date: 11/04/2013
Comment:
I am a medical practice manager and RN by background. [PHI Redacted] I happen to be the practice manager for an interventional pain practice that was one of the early adopters of mild. I am frequently called upon to share my experience, the cost, and outcome with patients who are considering this option. I also share the fact that not everyone will find certain relief from all or any of their stenosis/claudication. Nevertheless the vast majority opt for the procedure rather

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MANCHANDA, VIVEK Title: MD
Organization: ELPIS PAIN MANAGEMENT CENTER
Date: 11/04/2013
Comment:
The Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (PILD) procedure is is a safe and effective treatment for lumbar spinal stenosis for patients who are poor surgical candidates with multiple medical problems. On review of multiple studies, Patients experience a durable reduction in pain and improvement in functional mobility with no adverse events. Patients have reported decreased pain scores and increased walking distance after the procedure for up to 1.5 years

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Carayannopoulos, Alexios Title: Medical Director
Organization: Lahey Hospital and Medical Center, Department of Neurosurgery
Date: 11/04/2013
Comment:

I am a physiatrist with fellowship training in pain medicine, practicing for 8 years. I am dual board certified in PM&R and Pain Medicine. I am the Medical Director of a hospital-based multi-disciplinary spine center, within a department of Neurosurgery. My department did extensive research about the MILD procedure prior to adopting it into our practice. Based upon good data, which is not even available for many of the interventional or surgical treatments we offer, such as spinal

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Zaffarkhan, Khyber Title: Physician
Organization: Fullerton Orthopaedic
Date: 11/03/2013
Comment:

As a board certified Physician in physical medicine and rehabilitation I am beyond disappointed with CMS’ decision for non-coverage of the mild (pild) procedure. CMS has made many miscalculated assumptions in its proposed decision those of which I wish to address.

Having performed this procedure on 40 patients, I can attest to the fact the mild procedure is safe, efficacious, and a necessary treatment for patients with lumbar spinal stenosis. My patient success rate continues to

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Burfeind, Rebecca Title: Physician
Date: 11/03/2013
Comment:

I strongly encourage CMS to reconsider coverage for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis. This procedure helps to fill an unmet patient need in that it is indicated for patients unable or unwilling to undergo open lumbar decompression. I have performed this procedure since it's origination, and have been impressed with the pain relief it provides to patient with no other options.

While CMS points out that there is a lack of consensus on

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Mitry, Ragai Title: M.D.
Organization: Sarah Bush Lincoln Health Center, Mattoon, IL
Date: 11/03/2013
Comment:
I have used the MILD procedure in 5 patients. All were elderly, frail, and had significant spinal stenosis, with real difficulty walking. Every single one of them improved TREMENDOUSLY after MILD. Two of the were using canes/walker, and both of them were able to go shopping for over an hour without cane or walker. One of them agreed to write a letter, and it was forwarded to Vertos Medical earlier. Given the high benefit/low risk profile of MILD, I find it unbelievable that you oppose it.

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Ky, Paul Title: Doctor of Osteopathic Medicine
Organization: Advanced Pain Solutions
Date: 11/03/2013
Comment:

Disclosure: I have NO financial ties to Vertos except to earn the fees as a physician, which is about $841 from Medicare per case for a Medicare-Medical case, which is barely enough to cover the cost of doing the case because I have workers in the office that must be paid while I'm away doing the case (But, that's another issue).

I am astonished and sadden to hear that the MILD procedure will no longer be covered by Medicare especially, in light of such EXCELLENT outcome for my

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Vaisman, Julien Title: Instructor of Physical Medicine
Organization: Harvard Medical School
Date: 11/02/2013
Comment:
I have performed a total of 16 MILD procedures over the past 2 years for patients with severe to moderate spinal stenosis who essentially were facing surgery. A total of 4 patients had complete relief of the pain, 9 patients had 50% pain relief and they were happy with the outcome. The remaining 3 patients had only short term relief and the pain returned to baseline. There were no complications. I believe that in expert hands, the procedure is safe and has a significant role for patients who

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KEHAYES, ALEXANDER Date: 11/02/2013
Comment:

I am a retired anesthesiologist. In my professional career I administered anesthesia for hundreds of lumbar surgical interventions. Also, I probably administered, myself, at least one hundred epidural steroid injections. Familiar with those modalities for treatment of back pain, radiculopathies and spinal stenosis, [PHI Redacted] the MILD procedure was effective and of sixteen months duration and counting.

Respectfully,

ALEXANDER R. KEHAYES, M.D.
Anitescu, Magdalena Date: 11/01/2013
Comment:
I have been using this procedure several times.
While it is not a magic bullet, I do stringly believe that it is allowing us, pain physicians, to better serve our patients.
the situations I have been using it were in general quite desperate where 70+ year olds with severe spinal stenosis due to ligamentum flavum hypertrophy were unable to walk more that 5 steps due to severe pain in the legs; the procedure I performed in thos epatienst improved their ability to walk to 1-2 blocks and

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Simopoulos, Thomas Date: 11/01/2013
Comment:

I writing to comment of the treatement option of minimally invasive lumbar decompression for lumbar spinal stenosis. The diagnosis of lumbar spinal stenosis is the leading cause of benign low back pain leading to functional disability in our aging population. Imaging modalities such as magnetic resonance imaging or CT readily establish the presence of this condition. Through patient history, physcial exam and diagnostic nerve blocks other sources of low back pain can in the vast majority

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Penhollow, Tammy Title: Medical Director
Date: 10/31/2013
Comment:
MILD is one of the interventional pain management procedures we can actually monitor for change/effect while we're performing it. The epidurogram changes from very little to no flow prior to removal of the ligamentum flavum to free flow of contrast. The patient response to decompression of central canal stenosis is also measurable - about 4 point reduction on the VAS and a significant decrease in the disability score. These are sustainable results. Whereas an epidural steroid may or may

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Harmer, Jon Title: Medical Director
Organization: Lone Star Pain Medicine
Date: 10/31/2013
Comment:
PLease reconsider your position of the percutaneous Image-Guided Lumbar Decompression for lumbar spinal stenosis. This procedure is perfect for those patients who do not want general anesthesia and are scared of lumbar spinal surgery. I have found great results with this procedure with over 70% saying they would have it again or tell a friend to have it. It has helped them walk farther and really with lumbar spinal stenosis it is the only other option other than open laminectomy. Please

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madhipatla, venu Title: MD= pain physician and anesthesiologist
Organization: Colquitt regional medical center. Moultrie , Ga
Date: 10/31/2013
Comment:
It is a very good procedure for the spinal stenosis. It is a blessing for old and morbid patients who cannot stand anesthesia and surgery. I am hopeful that this procedure is going to serve the community so that they don't have to go for avoidable surgeries. We can improve the quality of life of the patient with this procedure.
Venu
Krishnan, Suresh Title: MD
Organization: INTERVENTIONAL PAIN CARE
Date: 10/31/2013
Comment:

I am a pain management physician with board certification in anesthesia and pain management.

I have a fair amount of experience in doing the PILD procedure. I have nothing but success in treating and helping the patients with this procedure. The elderly and frail people especially would do very well with this minor simple procedure rather than go through a more extensive and more complicated procedure which does not guarantee the results also for a long time. The added

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Thwaites, Brian Date: 10/31/2013
Comment:
Lumbar spinal stenosis is a debilitating condition of the elderly which eventually limits or eliminates the ability to walk. Many of the patients who experience spinal stenosis have other chronic illnesses which preclude open lumbar decompressive surgery under general anesthesia. The PILD procedure has proven to be a safe and effective alternative to open decompressive surgery. I believe the scientific literature supports the efficacy of PILD and the morbidity will certainly be lower(hospital

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Dragovich, Anthony Date: 10/31/2013
Comment:
Yesterday I saw a 71 year old elderly female with l3/4 central stenosis secondary to ligamentum flavum hypertrophy. She isn't a surgical candidate and has severe, life style limiting pain. She can't walk more than 50 feet without severe pain. An epidural provide 2 weeks of pain relief. Her options at this point are limited to either suffering or opioids. Opioids carry the risk of significant constipation and increased risk of falls especially in an elderly female who lives alone. She

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melendez, john Title: Director Pain Management West Palm Beach VAMC
Organization: Veterans Administration
Date: 10/30/2013
Comment:

I currently identify patients who are been refered to Dr Rasso in Palm Beach Gardens Florida. The crriteris we use is stricck as not everyone should be getting this king of treatments Now for example our ccriteris is Spinal Cord Stenosi who have significant functional related pain and have thickening or the posterior aspect ofthe canal ( ligamentum of Flavum) In our experience this patients had been treated w translaminar epidurals with very minimal help but inview of the little help they

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Patel, Adarsh Date: 10/30/2013
Comment:

A lack of consensus on treatment of LSS & existence of other treatments: invasive spinal surgery resulting in permanent anatomical changes already exists. These procedures do not guarantee (as any other medical procedure) positive outcomes. The MILD has no permanent consequences based on the technique.

There are still questions about adverse events related to the procedure: if performed by a ACGME trained and course certified person who has been proctored with real cases, there is

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Ring, Kevin Organization: Trinity Development Company
Date: 10/30/2013
Comment:

[PHI Redacted] used this procedure rather than back surgery for a problem that was very debilitating for him. It worked beautifully, had a very fast recovering, and saved Medicare a lot of money vs. back surgery. He could hardly walk before and now walks normally without pain.

I would STRONGLY recommend that you reconsider dropping this procedure. It will end up costing you more money if you do. Also, this is the kind of non-invasive technology that brings

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Ring, Gail Title: A VERY CONCERNED AMERICAN!!!
Organization: AMERICA ~ LAND OF THE FREE, HOME OF THE BRAVE!
Date: 10/30/2013
Comment:

Lumbar Spinal Stenosis (CAG-00433N) also known as MILD procedure was done on my [PHI Redacted] to correct extreme back pain. This was a perfect solution to years of back pain. It worked beautifully and was far less intrusive and less expensive that full back surgery. He walked out of the minor surgery just one hour later and had very small incision - of less that an inch!

PLEASE PLEASE PLEASE keep this procedure within the allowable guidelines of Medicare!
udwadia, jamie Title: physician
Organization: Vidant Oupatient rehabilitation medicine
Date: 10/29/2013
Comment:
I just wanted to share my thoughts on the MILD procedure. As a physiatrist, a have a medical management pain clinic. I have had a good number of patients who have had this procedure performed with fairly good results. Before sending a patient for a much more invasive procedure such as a lumbar fusion, I feel that this is much less risky and a reasonable option for certain diagnosis.
Petalcorin, Joan Date: 10/29/2013
Comment:
I understand why Medicare would not support PILD/MILD. However, IF we were to be patient-oriented, this procedure SHOULD be given as an option to the patient especially those who do not want the big open lumbar surgeries. NOT all spinal stenosis patients will need this BUT for those who will benefit from this because of neurogenic claudication symptoms from the spinal stenosis, this shoulder be offered by the physician, and therefore should be covered by Medicare. WE all know that spinal

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Brocks, John Date: 10/29/2013
Comment:
[PHI Redacted] In my opinion your prospective action on this procedure is penny foolish and foolish.
Kramer, Sten Title: physician
Organization: Kramer Orthopedics
Date: 10/29/2013
Comment:

Regarding the draft coverage proposal for Percutaneous Image-Guided Lumbar Decompression (PILD), also known as Minimally Invasive Lumbar Decompression (MILD), it is my understanding that the CMS draft policy indicates that there is insufficient evidence proving that the MILD procedure is reasonable and necessary, and the therapy should, therefore, not be covered by Medicare. I would like to share my personal experience with the MILD procedure. I understand that I can only give anecdotal

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Neleson, Craig Title: Craig Neleson, MD
Organization: North Texas Precision Pain Care, PA
Date: 10/29/2013
Comment:
I believe this procedure should be covered as logically, in properly selected patients, it should relieve stenosis. I am under the impression that Cleveland Clinic has been doing these procedure with good results. This procedure should save a lot of money from typical open laminectomies. If your research is counter to this I would appreciate receiving this.
Hoff, Jeremy Title: physician
Organization: Hampton Roads Ortho and Pain Management
Date: 10/28/2013
Comment:

Having performed only 25-30 of these procedures I find them to be clean, safe, and really a common sense procedure. It is unfortunate that a procedure potentially offering relief of a complex problem in the setting of improved quality of life and pain control is being burdened in its infancy with proof that is not required of it's competing procedures. Epidurals for LSS have been shown to be ineffective in an article published last month in Pain. Yet this treatment is not under fire. There

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Spivey, David L Title: Medical Director
Organization: Preferred Pain Management and Spine Care, PA
Date: 10/28/2013
Comment:

I have performed over fifty MILD procedures for lumbar spinal stenosis and neurogenic claudication. The vast majority of these patients are elderly with comorbidities or were other wise unsuitable for more invasive (traditional) decompression surgical procedures. All patients have enjoyed improvement in standing time and walking distance. Many view the procedure as a "miracle" in regards to the regained function in their lives. The procedure requires minimal sedation and local

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Johans, Thomas Title: MD
Organization: WAAI
Date: 10/27/2013
Comment:

I have been practicing pain management for over 30 years through the discipline of the American Board of Anesthesiology. Whereas pain management started officially in 1957 in Seattle WA, it has matured into a very important academic medical specialty as we have something to bring to the therapeutic table for patients that no other practitioner has to offer.

There are many holes in our armamentarium to treat chronic spinal pain. One of those is the clinical canundrum of what to do

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PATEL, nilesh Title: Orthopaedic Spine Surgeon
Organization: Michigan Orthopedic Specialists and Wayne State University
Date: 10/27/2013
Comment:

As a practicing Orthopaedic Spine Surgeon I am disappointed with the decision by CMS. I have performed this procedure over the last three years and have had success with the procedure that is equal to my success with lumbar microdecompression and laminectomy. Additionally this procedure can be performed in patients who are not eligible for other surgical intervention due to their poor medical history and medical comorbidities.

Many of my patients that did not have an alternative

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Tucker, Anhtony Date: 10/27/2013
Comment:
MILD is a cost effective lower risk alternative to much more expensive and riskier procedures to treat spinal stenosis. I beleive in this era where value in healthcare is paramount, MILD is exactly the type of procedure that should be supported. Chronic pain has a huge healthcare cost burden in the US. Coupled with the this country's epidemic of prescription opioid misuse due to over reliance on opioids for the treatment of chronic pain, CMS should be going out of its way to advocate for

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Seitzman, Howard Title: Medical Director of Atrium Pain Center
Date: 10/26/2013
Comment:

I appreciate the opportunity to comment on the National Coverage Analysis for Percutaneous Image-Guided Lumbar Decompression. I am a practicing Board certified pain physician with 28 years of experience. I have been doing the PILD procedure for over 2 years during which time I have performed over 150 of these procedures. I have found the procedure to be safe and effective. The effects have shown to be durable in my patients. They have utilized my services much less or not at all

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Debiec, Jozef Title: MD- PHYSICIAN; Interventional Pain Management
Organization: Phelps Memorial Hospital, Sleepy Hollow, NY
Date: 10/26/2013
Comment:

As patients continue to age, there will be an increase in the diagnosis of lumbar spinal stenosis. Patients are living longer and are sicker today than they were in the past. Many of these patients have serious co-morbidities which excludes them from undergoing general anesthesia. The MILD procedure offers these patients a good chance to improve their pain and quality of life.

The current treatment of lumbar spinal stenosis if its severe enough, would be an open laminectomy.

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Dragovich, Anthony Title: Physician
Organization: Blue Ridge Pain Management
Date: 10/26/2013
Comment:

I served in many duties while an active duty Army pain medicine physician including pain medicine consultant to the Surgeon General of the Army.

I performed many of these procedures on active duty soldiers who had neurogenic claudication secondary to ligamentum flavum hypertrophy while I was a pain medicine physician in the army. The results were excellent and soldiers were able to remain on active duty who otherwise would have required a medical board.

There is not a

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Richardson, William Title: MD
Organization: Southeastern Spine Institute
Date: 10/25/2013
Comment:

I am deeply disturbed by the potential loss of MILD as a treatment option for patients. I have had excellent success with this procedure. I have regularly been utilizing the MILD over the last 3 years with amazing success. I have patients off all medications, back to normal activities without limitations and extremely happy with their outcome.

This is an amazing treatment modality with fast recovery and great results. Vertos claims "70% relief in 70% of the patients" and that

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Gauthier, Michael Date: 10/25/2013
Comment:
I am an active pain management physician. I provide many different procedures for my patients. I do not currently offer the MILD procedure but I have followed its developement and have discussed its success with other providers. This is a valuable tool to treating specific patients with spinal stenosis and I urge CMS to approve this procedure.
Murphy MD, Charles William Title: President, CEO, Medical Director
Organization: Hill Country Pain Associates
Date: 10/24/2013
Comment:
I am a pain specialist in San Antonio Texas. I am trained to perform the PILD or MILD procedure and have performed the procedure on 9 patients. The detail that is missed in your analysis of the procedure is that it is indicated in a particular group of patients for which there is no other acceptable treatment. The patients with central LSS that is primarily due to ligamentum flavum thickening of greater than 3 mm, and symptoms that correlate with narrowing at that specific level. In

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Shwartzman, Boris Title: physician
Organization: Park Anesthesia, inc.
Date: 10/24/2013
Comment:

I have reviewed the CMS draft coverage proposal for Percutaneous Image-Guided Lumbar decompression and am uphold by the findings. The decision seems to be motivated by something other than scientific facts. Specifically, issues listed, like lack of consensus of diagnostic criteria for LSS is as for from reality as possible. There are clear clinical and radiographic criteria for the diagnosis. Second finding contradicts the first one, lack of consensus of treatment of LSS and existence of

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Yousaf, Muhammad Date: 10/24/2013
Comment:
I am an interventional radiologist and neuro interventional radiologist doing pain management as well. I have done MILD (PILD) fair number of cases in VA system and so far proven very helpful for reduction of pain and improvement in walking. Procedure is also an option for patients who are not candidate of surgery for spinal canal stenosis or not interested in surgery.
kim, philip Date: 10/24/2013
Comment:
I strongly suggest change in the determination for this procedure. The evidence is certainly much more than other procedures that CMS covers such as kyphoplasty and other minimal invasive spine and surgical procedures. The studies are solid compared to other studies. I have seen this work in the selected group of patients that is beyond placebo effect. The criticisms are overwhelming by spine surgeons who feel it threatens their practice. The explanation of not receiving a change in

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Quave, Brett Title: Physician (Medical Director)
Organization: THE HAVEN Pain and Spine Center
Date: 10/24/2013
Comment:

This message is from my perspective as a pain medicine physician who provides full spectrum pain care utilizing 4 pillars of pain management -medicine/interventional care, rehabilitative approach, psychological approach, and lifestyle approach. I am an interventionalist that has worked very closely in a multidisciplinary setting for spine care along with neuro and orthopedic spine surgeons, PT, psychologists, radiologists, physiatrists, nurses, and other anesthesiology pain

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rho, james Title: MD
Organization: inland interventional med. assoc, inc
Date: 10/23/2013
Comment:

CMS,

MILD procedure is a highly efficacious procedure that is minimally invasive with low risk to the patient.

Diagnostic criteria for lumbar stenosis is quite well establishied in terms of symptoms , signs and imaging studies.

Currently, the surgical treatment of open spinal decompression carries significantly higher risks with significant portion of patients who simply can not under go such procedures due to anesthetic risks 2nd to concurrent

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Kloc, Ronald Title: Physician
Organization: Illinois Valley Community Hospital
Date: 10/23/2013
Comment:
I was trained to do the MILD procedure by Vertos Medical in October 2020, and subsequently performed the procedure on 44 patients until the Medicare provider for the State of Illinois stopped covering it. I had excellent results in 35 patients with greater than 50% pain relief, good results in 3 patients with 25-50% pain relief and no improvement in 6 patients. I've found the MILD procedure to be an excellent procedure in patients suffering from lumbar central spinal stenosis due to

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Botelho, MD, Ronald Title: Ronald J. Botelho, MD
Organization: Interventional Pain Management
Date: 10/23/2013
Comment:

I am disappointed in the decision to not allow PILD/MILD procedures for those in need. First, it is a diagnosis that can be made with some certainty unlike generalized low back pain as stated. Patients have progressive pain on walking or sometimes even standing, often ameliorated by a flexed posture, and severe to the point of finally having to stop due to severe pain or weakness. Many of my patients cannot make it from their car to the office without stopping to sit. Sitting for a few

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Richardson, Donald Title: Professor Emeritus Neurological Surgery
Organization: Tulane University Health Science Center
Date: 10/23/2013
Comment:
This procedure is ideal for elderly patients who are poor risk, do not have an expected long life, are refractory to the usual pain management and will not well tolerate a major procedure requiring general anesthesia. Spinal stenosis is not a benign disease, it produces marked limitation of physical activity, intractable pain and eventually cauda equina syndrome with loss of use of the lower extremities and bowel and bladder control.
Gu, Yaoming Date: 10/23/2013
Comment:

The clinical diagnosis of LSS is well established. Diagnosis of LSS is not based solely on radiological findings, but primarily on sound history and physical. Patients selected for PILD should have documented symptomatic neurogenic claudication and decreased function with respect to standing time of less than 15 minutes and walking distances under 350 feet. Radiological findings should then be used to validate the H/P. For patients in this condition and having failed conservative

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Bojrab, Louis Title: Pain Physician
Organization: Michigan Pain Specialists
Date: 10/23/2013
Comment:

MILD is an large advancement of spine treatment for patients with symptomatic lumbar stenosis with hypertrophied ligamentum flavum that respond to epidural injections but do not desire or require a laminectomy, or when a laminectomy would necessitate an instrumented lumbar fusion. It spares these patients significant morbidity in decreased risk of dural tear, infection, hardware failure, nonunion, and general anesthesia. The patient outcomes in my practice have been tabulated and the

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Bosscher, Hemmo Date: 10/23/2013
Comment:
I have performed close to a hundred MILD procedures.
The number of positive outcomes multiplied by the degree of improvement minus the number of negative outcomes multiplied by the severity of the negative outcomes must beat the alternatives by a land slide (surgery or palliative care) To deny the procedure to a patient with severe spinal stenosis becomes now an ethical problem. The members of the reviewing board will have to take personal responsibility for their decision. Meanwhile I

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Harlin, Daniel Title: Interventional Neuroradiologist
Date: 10/23/2013
Comment:

I have performed the MILD procedure on 14 patients, and EVERY PATIENT had greater that a 70% reduction in VAS pain scores to 3 years out. The procedure works, it is cheaper than traditional fusion with less risks, and it is extremely safe to perform.

Please reassess your coverage of this game-changing procedure.
GHAURI, MAJID Date: 10/23/2013
Comment:
Ask the Physicians and the patients before you make you reject MILD.
Chakerian, Maia Title: Sole Proprietor
Organization: Silicon Valley Pain Center
Date: 10/22/2013
Comment:

I am a practicing physician in CA, and have been performing the mild procedure for about 2 years. This has been done in the course of clinical practice, not in the context of a controlled clinical trial. I have performed this procedure on approximately 12 patients, whom I have considered to be non-surgical candidates, who were suffering significantly from neurogenic claudication, and for whom other measures were not effective. Out of these 12 patients, two did not improve with the mild

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Chiu, Paul Title: President
Organization: Vanguard Interventional Pain Specialists
Date: 10/22/2013
Comment:

I am a full time practicing board certified interventional pain specialist who has done over 50 MILD procedures over the last year.
This is an excellent therapy option for patient with lumbar spinal stenosis or neurogenic claudication problem who are either not a candidate for corrective spine surgery or failed conservative lumbar epidural corticosteroid injection.

Of the 50 plus patients that I have treated, none of them have complained of any neurologic damage or worsening

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Bevard, Brent Title: Doctor of Osteopathy
Organization: ABQ Health Partners
Date: 10/22/2013
Comment:

It would be a shame if MILD procedure were to be denied as a viable treatment option for my patients and your members who suffer from lumbar central stenosis. I have performed this procedure on approximately 70 patients. I have not had one complication or adverse affect. We have not perform specific outcomes research but I would estimate that greater than 50% of these patients received functional improvement as well as reduction in low back and lower extremity pain.

In the last

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Hancock, MD, Dan Date: 10/22/2013
Comment:
I am well-acquainted with the Vertos MILD precedure and it is my medical opinion that this is a dangerous procedure and should not be covered under CMS reimbursement guidelines. The procedure, in general practice, is not perforomed only on those individuals with lumbar ligamentous hypertrophy contributing to lumbar spinal stenosis, but is often done on individuals with facet arthropathy and disc bulging contributing to the stenosis. Also, contrary to the current VERTOS recommendations, this

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Bhaskara, Sri Organization: Advanced pain care clinic
Date: 10/22/2013
Comment:

This is an effective, inexpensive, safe, outpatient therapy for patients with lumbar spinal stenosis. Results are readily verifiable. CMS should offer MILD procedure before open surgical decompressions. Surgical decompressions are expensive, time consuming, risky hospital based procedures that offer only limited relief of symptoms for upto 2 years.

Cost saving procedures like MILD should be available to all medicare and medicaid recipients.
Krishnan, Kalyan s. Title: Senior Consultant,Dept. of Pain Medicine
Organization: Geisinger Health System
Date: 10/22/2013
Comment:

The indications for MILD are classic neurogenic claudiation involving lower extremities . Patients with low back pain brought on standing/walking & relieved by sitting/forward flexion & who have documented spinal stenosis as per their MRI.These patients with low back pain are usually treated with facet nerve blocks & facet denervations.If they do not respond to these 2 modalities they may be considered for MILD or PILD.
MILD challenges the age old concept that spinal stenosis has 3

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jiha, jihad Date: 10/22/2013
Comment:

I am disappointed to see the opinion of CMS regarding MILD. I was very pleased to do this procedure on patients who have spinal stenosis caused mostly by ligamentum flavum hypertrophy, and causing neurogenic claudication. It helped several patients a lot. Unlike epidural steroid injections, the effects were not temporary, and the relief was long-lasting. They were able to walk, stand, and do their ADL with significantly less limitation.
The criteria for doing MILD are well established,

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Reddy, Subash Title: President
Organization: Reddy&Associates,P.C
Date: 10/22/2013
Comment:

I have done several percutaneous decompression procedures. Some patients had excellent results with improved ambulation and reduction in pain. Activities of daily living has improved. Other patients had moderate relief in pain and improved function. Few patients had minimal relief. No major complications encountered.

I believe the MILD Procedure is an option that can be offered for spinal stenosis as an alternate to surgical intervention.
Abraham, Benjamin Date: 10/22/2013
Comment:

I agree that the coverage of Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis is not warranted based on the available evidence.

The large number of industry-funded trials, and lack of non-industry funded randomized controlled trials demonstrating durable long-lasting improvement in function do not exist.

More study is needed.

Willis, James Title: MD
Organization: James A. Willis MD. Pain Management Consultant
Date: 10/22/2013
Comment:

The proposed Medicare non-coverage for percutaneous minimally invasive lumbar decompression should not be adopted. This procedure provides relief for elderly patients with severe neurogenic claudication without exposing the patient to the risks attendent to a lumbar laminectomy ond fusion. Many of the patients who have benefited from MILD have severe activity limitations due to their stenosis, and also have significant co-morbidities which place them at high risk for spine surgery and

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Guglani, Pankaj Title: M.D.
Organization: Prizm Pain Specialists LLC
Date: 10/22/2013
Comment:
I am writing to regarding the recent CMS withdrawal of coverage for MILD procedure as the result of an NCA process from April of 2013. I strongly believe the procedure needs to be supported and covered for patients. This procedure provides meaningful and significant reduction of pain related to lumbar spinal stenosis. This is a diagnosis with CLEAR and MEASURED criteria, as well as having clear and measured outcomes. Treatment options for this diagnosis are very limited and the results of

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Burns, Jonathan Title: Physician
Organization: SpineNevada
Date: 10/22/2013
Comment:

I have only done a few of these cases, but the outcomes have been very good. Patients sometimes feel benefits from the procedure right away and it is pretty dramatic. I think it is a very valuable tool for pain management providers to have, especially in patients who are not traditional surgery candidates or do not wish to undergo more invasive surgery. Regarding the concerns raised by CMS, it is my opinion that there is clear diagnostic criteria for LSS both clinically and with

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Moghal, Nadeemm Title: MD
Organization: Toledo Pain Services
Date: 10/22/2013
Comment:

I am writing in response to the NCD re: PILD. I am a ABA board-certified Anesthesiologist with ABA Subspecialty Certification in Pain Medicine since 2007. I did my residency and pain fellowship training at the Cleveland Clinic Foundation, finishing in 2005. I have been performing the PILD procedure since 2010. I have seen it be extraordinarily successful for the patients I have performed it on. They have gone from having severe radicular pain in the leg or legs to having none at all.

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Cabrera-Bonet, Pedro Title: MD
Organization: Centro de Medicina del Dolor
Date: 10/22/2013
Comment:
I have performed MILD procedure on several patients with excellent results. This is a life changing procedure for all the patients I have taken care. The data is there to prove the efficacy, safety and simplicity. Please the following video I made of one of my patients, is the best proof of the efficacy of the procedure. This the link: http://youtu.be/mOHENLoXuY0
Mazloomdoost, Danesh Organization: Pain Management Medicine
Date: 10/22/2013
Comment:

I would like to comment advocating for the continued funding of the MILD procedure. My comments are directed to the rationale provided against the technique:

1. A lack of consensus on diagnostic criteria for LSS: A large part of what a well-trained pain physician does is identify the etiology of pain. Historically this has been a great challenge for all physicians involved in spine care (neurosurgeons, orthopedic surgeons, pain specialists, etc). Nonetheless, with modern approaches

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Chatas, John Date: 10/22/2013
Comment:

MILD meets an unmet patient need for patients with symptomatic lumbar stenosis with HLF that respond to epidural injections but do not desire or require a laminectomy, or when a laminectomy would necessitate an instrumented lumbar fusion. It spares these patients significant morbidity in decreased risk of dural tear, infection, hardware failure, nonunion, and general anesthesia. The patient outcomes in my practice have been tabulated and the results exceed those of laminectomy for these

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Guthmiller, Kevin Date: 10/22/2013
Comment:
From a Pain Physician perspective, there appears to be probable benefit in patients who suffer from spinal stenosis with neurogenic claudication specifically from ligamentum flavum hypertrophy. The mild procedure is likely very safe to perform, can be done in an office-based setting, and in a select patient population, could serve as an effective minimally invasive treatment option to lumbar decompression surgery.
Guernelli MD, John Title: MD Physical medicine and rehabilitation
Organization: Spectrum medical Group
Date: 10/22/2013
Comment:

I have been performing a minimally invasive lumbar decompression's for approximately 2 years. A total of 19 patients treated 18 of demonstrated significant clinical and functional improvement. These patients were well selected as having clearly demonstrated central canal narrowing based on thickening of the ligament and flavum as well as clinical symptoms of neurogenic claudication. This subgroup of patients had failed extensive conservative management including epidural injections and/or

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Harum, Kirk Title: Physician
Organization: Crystal Coast Pain Management
Date: 10/22/2013
Comment:

I have been performing the Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis for over 2 years.

The procedure has a place in patients that have lumbar spinal stenosis due in part to ligamentum flavum hypertrophy and are too sick to undergo a surgical laminectomy.

It also has a place in those patients that choose not to have surgical laminectomy.

In my experience, my patients have long term results. I have discharged many patients from

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Pease, MD, Sonya Title: CMO TeamHealth Anesthesia
Organization: TeamHealth
Date: 10/21/2013
Comment:
I have many Chronic pain ,management docs who do this procedure across the country. There is definately a sub-set of patients that benefit from this procedure and i know i speak for many in saying this should not be non-covered across the board. Perhaps a better discription of which patients benefit most and circumstances that would be covered should be defined.
Memon, Rehan Organization: Cabell Huntington Hospital
Date: 10/21/2013
Comment:
It's really sad. As a physician performing MILD procedure, I can see a real benefit of this technique in patients who are either 'high risk' to undergo surgery or do not want to undergo open surgery for symptomatic lumbar spinal stenosis. Generally, Medicare population is considered a high risk patient population with other concurrent comorbidities. Refusing to cover PILD procedure ensures that these patients only get one treatment only, open surgical laminectomy or fusion. Medical management

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Homberg, MD, Eric Title: MD, Board Certified Anesthesiologist
Organization: Jackson Interventional Pain Center
Date: 10/18/2013
Comment:

I am saddened for the patients that will not benefit from this great alternative to the already limited, effective, treatment options for LSS.

The incidence, of functional limitations, from LSS in the population is greatly underestimated.

The subgroup of patients that cannot undergo traditional open decompression is very large.

The option for PILD is desperately needed.

My personal experience with performing the procedure is that it is extremely effective,

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Singh, Amit Title: Physician
Organization: Pain Specialists of South Carolina
Date: 10/18/2013
Comment:

I am writing to state that I strongly disagree with this proposed decision of non- coverage.

My experience with the MILD procedure began in 2011. In the last 2 years I have performed this procedure for 18 patients. Of these patients, all but two have had improvement in their pain as well as their general activity level. After failure of conservative measures, this procedure allowed these patients to maintain if not improve their quality of life. Also, these patients were able to

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Schultz MD, David Date: 10/18/2013
Comment:
I have performed the MILD procedure on well selected patients over the past 2 years with good results. I have had no complications and approximately 70% of my patients have experienced good resolution of neurogenic claudication symptoms. This is the success rate predicted by multiple studies published on the MILD procedure. I believe this procedure is a viable alternative to more aggressive and high risk spine surgery especially in the elderly Medicare population of patients with spinal

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Lendado, Tegga Organization: OASIS Language Services (Medical Interpreter)
Date: 10/17/2013
Comment:
From a lay man point of view this is a scientific conclusion. I do not totally understand the procedure and its outcome. However, I would like to suggest that while further research is continuing, other para-medical, traditional, psycho-physical, valid alternative medicine and therapeutic remedies should also be sought and accorded to patients.
Baumgartl, MD, William Title: MD
Date: 10/17/2013
Comment:

I have been performing this procedure and have seen the success first hand. There are otherwise no reasonable options for many of the elderly patients who receive this therapy. I have seen many patients come in barely able to walk 50 feet, who later can walk a quarter mile a few weeks later. In deciding on this procedure, the reviewers should consider what therapy they would want if there were elderly, frail, and suffering from severe stenosis. What would they want their parents to do

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Uraine, Shawn Date: 10/17/2013
Comment:
I have seen the result of this procedure in several patients and the benefits are great and obvious. The biggest naysayers of this technique are spine surgeons who feel that they will lose money due to increased competition in treating patients with lumbar spinal stenosis and neurogenic claudication. Spine surgeons are protecting their turf. My personal observations are that people who receive spine surgery do not demonstrate the great and obvious benefit that MILD offers. I maintain that used

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Davis, John Organization: Retired student & Vietnam-era veteran; therefore simply Retired
Date: 10/17/2013
Comment:
Concur.
chafin, timothy Title: director pain care
Organization: vidant roanoke chowan hospital
Date: 10/17/2013
Comment:
I have personaaly performed over 560 of these procedures. This procedure should be approved. Results of my procedures have been recorded over the past 8 months. I would encourage members of the committee to vsit my facility, observe both pre and post surgical outcomes.
Fetters, Mary Date: 10/17/2013
Comment:
With back problems so common with older people and sometimes younger ones too, seems like the diagnosis and treatment for the suffering it causes should be covered by most peoples ability to receive the care they need. The pain from a back problem can be devastating and debilitating.