National Coverage Analysis (NCA) View Public Comments

Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis

Public Comments

Commenter Comment Information
Thacker, M.D., James Title: President
Organization: Huntsville Pain Management, Inc
Date: 10/08/2016
Comment:

I have treated many patients with the mild procedure with successful outcomes. This procedure gives patients an opportunity to improve their quality of life and functionality while minimizing the economic expense of open surgery. I have had a patient arrive in a wheel chair and walk out of the hospital following the a mild procedure with reduced pain. The proposed cohort study would not provide new information as the recent CED study, MiDAS ENCORE, produced level 1 data which supports the

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Ryan, John Title: Partner
Organization: ONSET Ventures
Date: 10/08/2016
Comment:

Thank you for your consideration of my comment. I have worked with medical innovation and emerging medical technology companies for over 20 years primarily as a venture capitalist, but also as an advisor, guest lecturer, board member of a large integrated health care delivery system, founding member of an angel investment group, etc. My venture capital firm is an investor in Vertos Medical and I am on the board of directors of the company.

The comments posted so far have focused

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Klagges, Brian Title: Director, Interventional Spine Center
Organization: Elliot Hospital
Date: 10/08/2016
Comment:

CMS stands to lose credibility.

PILD should not be subject to any further study as a prerequisite for medicare coverage. Mild has been shown- over and over again - to be safe and effective.

Lumbar spinal stenosis is a condition that affects many patients in our clinic; a clinic that sees over of 12,000 patient-visits annually. The condition can place a very heavy burden on both the patient as well as supporting family members - as well as a financial burden on

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Proano, Fabian Title: MD
Organization: Pain & Rehabilitation Medical Group
Date: 10/08/2016
Comment:

CMS needs to approve the Percutaneous Image-guided Lumbar Decompression procedure. The outcome study demonstrating safety and efficacy has been met via the Midas Encore study. There is no justification for further costly and unnecessary research to be performed prior to approving the procedure. I have already had to defer countless patients who would have benefitted from this procedure, and further delays will only deny access to many, many more patients who suffer from spinal stenosis

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McNeil, Chad Title: MD
Organization: Azalea Orthopedics
Date: 10/08/2016
Comment:

I write you today as a concerned physician hoping to make available a proven and effective treatment for my patients. I had the opportunity to use Image guided lumbar decompression for lumbar spinal stenosis in my practice and the results I saw in clinical practice mirrored those proven in the MIDAS study. Unfortunately this safe and effective treatment has not been available to patients as CMS established the CED process and approved the ENCORE study to render a coverage decision. Once

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von Kaenel, William Title: M.D.
Organization: Spine Intervention Medical Practice
Date: 10/08/2016
Comment:

I am a interventional pain physician and Anesthesiology and Pain Boarded physician, writing in support of MILD.

I have performed >100 mild cases, and 18 as part of the MiDAS ENCORE Study. I've found clinically that it is effective, which is of course what MIDAS study found too.

The procedure serves a specific need of Medicare patients. There are many with stenosis that is significant, with limitations that are not lumbar decompression surgery candidates.

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Ams, Mary Kay Title: Program Manager
Organization: American Academy of Pain Medicine
Date: 10/08/2016
Comment:

October 8, 2016

Tamara Syrek-Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Mailstop S3-02-01
Baltimore, MD 21244
tamara.syrekjensen@cms.hhs.gov

Re: National Coverage Analysis (NCA) for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R)

Dear Ms. Syrek-Jensen:

The American Academy of Pain Medicine (AAPM) is

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Casasola, MD, Oscar de Leon Title: President
Organization: American Society of Regional Anesthesia and Pain Medicine
Date: 10/08/2016
Comment:

October 5, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd., Mailstop S3-02-01
Baltimore, MD 21244

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

Dear Ms. Syrek Jensen:

The American Society of Regional Anesthesia and Pain Medicine (ASRA), on behalf of its 4500 members,

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Hill, Catherine Jeakle Title: Senior Manager, Regulatory Affairs
Organization: American Association of Neurological Surgeons/Congress of Neurological Surgeons
Date: 10/08/2016
Comment:

October 6, 2016

Tamara Syrek Jensen, JD, 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

Subject: Proposed National Coverage Determination (NCD) for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R)

Dear Ms. Jensen,

On behalf of

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Wichems, Eric Title: President & CEO
Organization: Vertos Medical, Inc.
Date: 10/08/2016
Comment:

October 8, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Vertos Medical Comments to Medicare Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R)

Dear Ms. Syrek Jensen:

Thank you for the opportunity to comment on the Proposed

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Spivey, David Title: MD
Date: 10/07/2016
Comment:
I performed over twenty mild procedures on patients with spinal stenosis and neurogenic claudication. Some were unable to undergo decompressive laminectomy due to comorbidities and some preferred to avoid surgical intervention. All patients had some improvement in pain level and function, some dramatic improvement. There were no complications. In my opinion, the mild procedure should be available to these older patients, to improve their quality of life without the attendant risk and recovery

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Hackbarth, Mark Title: M.D.
Organization: Precision Spine Care
Date: 10/07/2016
Comment:
MILD or PILD procedure research has already proven to be effective and safe in multiple studies. For a time when this procedure was approved, I had personally performed several MILD procedures with excellent results. Most importantly this is a procedure that is less invasive and safer than conventional surgical decompression for lumbar spinal stenosis. As you may be aware stenosis becomes more common in advancing age. Also with advancing age so do many co-morbidities that make classical

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Syed, Mubin Date: 10/07/2016
Comment:

Mubin Syed, M.D.
Dayton Interventional Radiology

Dear CMS

Please consider reimbursement for the MILD procedure without the proposed prospective cohort study. I believe that the proposed prospective cohort study is not needed because there is already level one data through the recent CED study, the MiDAS encore study. Furthermore, there have been 20,000 patients that have been treated to date with over 12 studies that have been published to date. I believe

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Bearer, Ryan Title: DO, MPH, MS
Organization: Comprehensive Pain Specialists, PLLC
Date: 10/07/2016
Comment:
I am writing in support of coverage for the percutaneous image guided lumbar decompression for lumbar spinal stenosis. I have treated many patients in my practice over the past few years and have seen great improvements in the lives of my patients and the lives of 20,000 other patients treated by my colleagues. Furthermore, 12 published studies have been done on 668 MILD patients, and the recent CED, MIDAS ENCORE study produced level 1 data. In this study all primary and secondary endpoints

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DuRapau, Krista Title: Executive Director
Organization: Texas Pain Society
Date: 10/07/2016
Comment:

Texas Pain Society (TPS) is a 501c6 nonprofit organization that represents over 350 pain specialists in Texas. Our mission is to improve the quality of life of patients in Texas who suffer from pain.

We appreciate the opportunity to submit comments related to the NCA for Percutaneous Image-guided Minimally Invasive Lumbar Decompression (mild) for Lumbar Spinal Stenosis.

TPS is a stakeholder with our Texas local carrier, Novitas, we have members who serve as CAC

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Frankoski DO DABPM, Edward Title: Physician
Date: 10/07/2016
Comment:
I have performed a number of minimally invasive lumbar decompression procedures (MILD) and have found the results to be superior to that of epidural steroid injections. Furthermore, this is a safe procedure that can be performed on individuals who are older with excellent success in markedly reducing their pain and and increasing activities of daily living. I have seen absolutely no "post laminectomy syndrome" occurrences after the MILD procedure.
Mild has been scientifically studied

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Verdolin, Michael Organization: Pain Consultants of San Diego
Date: 10/07/2016
Comment:

It is with great disappointment I read CMS negative decision with respect to percutaneous image-guided lumbar decompression (PILD) procedure coverage. CMS promised in its deliberations during the previous request for national coverage determination (NCD) that CMS itself would co-design a study and based on the results of that mutually agreed study, should it meet the endpoints, offer coverage of PILD to Medicare beneficiaries as an NCD. It is beyond the pale that despite meeting all

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May, Donald Title: Exec VP, Payment & Health Care Delivery Policy
Organization: Advanced Medical Technology Association (AdvaMed)
Date: 10/07/2016
Comment:

October 7, 2016

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd
Baltimore MD 21244

RE: Proposed Medicare Coverage Decision Memorandum for Percutaneous Image-Guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) (CAG-00433R)

Dear Ms. Syrek Jensen:

The Advanced Medical Technology

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Cole, Daniel Title: Dr.
Organization: American Society of Anesthesiologists
Date: 10/07/2016
Comment:

October 7, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Mailstop S3-02-01
Baltimore, MD 21244

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

Dear Ms. Syrek Jensen:

The American Society of Anesthesiologists (ASA), on behalf of its 52,000 members, appreciates the

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Firnhaber, Juan Title: MD
Organization: ECPC Pain Specialist
Date: 10/07/2016
Comment:
MILD it is an excellent procedure for selected patients, when use in the right patient it can make a big difference in their quality of life. It is also very safe in the right hands.
I will like to see this procedure available for the patients suffering from lumbar spinal stenosis (due to ligamentum flavum thickening)that are not a very good surgical candidates.
Carayannopoulos, Alexios Title: Medical Director Spine, Pain, and Rehabilitation
Organization: Rhode Island Hospital, Comprehensive Spine Center
Date: 10/07/2016
Comment:
This procedure helped many of my patients who were not candidates for more invasive lumbar decompression or who did not want to pursue this option. When performed properly, this procedure is important in the continuum of interventional/surgical spine care for spinal stenosis.
Manchikanti, MD, Laxmaiah Organization: American Society of Interventional Pain Physicians®
Date: 10/07/2016
Comment:

October 7, 2016

Tamara Syrek-Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Mailstop S3-02-01
Baltimore, MD 21244

Cheryl Gilbreath, PharmD, MBA, RPh
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244
Cheryl.gilbreath@cms.hhs.gov

Re: National Coverage Analysis (NCA) for Percutaneous Image-guided Lumbar Decompression for

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Todd, Laurel L. Title: Vice President
Organization: The Biotechnology Innovation Organization (BIO)
Date: 10/07/2016
Comment:

October 7, 2016

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, M.D. 21244

BY ELECTRONIC DELIVERY

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

Dear Director Syrek Jensen:

The Biotechnology Innovation Organization (BIO) appreciates this opportunity to

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Byers-Robson, Michelle Title: Executive Director
Organization: FSIPP
Date: 10/06/2016
Comment:

Once again, on behalf of all the active members of the Florida Society of Interventional Pain Physicians (FSIPP), I would like to thank you for the opportunity to provide feedback on your recent “Proposed Decision Memo for PILD for LSS (CAG-00433R)”. As FSIPP has publically stated in previous open comment periods (05/04/2013 and 05/12/2016) we strongly support full, unrestricted access to the MILD procedure. Based on the extensive published outcome data available for MILD, and successful

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vascello, luis Title: md
Organization: baptist health lexington
Date: 10/06/2016
Comment:
Lumbar spinal stenosis (LSS) is one of the most common and devastating degenerative disorders of the elderly. The mild procedure has been indicated for a very specific group of patients: Patients who experience neurogenic claudication as a result of LSS where hypertrophy of the ligamentum flavum is a clear contributor of central canal stenosis. Patient selection for this procedure is not only based on physical examination and patient's history but must be supported by MRI findings (measurement

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Rosenberg, Jason Title: MD
Organization: President Crescent Moon Research, President SC Pain and Spine Sp
Date: 10/06/2016
Comment:
I would like to add my comments in support of coverage for the PILD procedure. I was fortunate to participate in the most recent clinical trials for both MILD and Totalis.
Using basic medical school criteria - if the risks outweigh the benefits, the proposed intervention would not be considered. If the intervention has minimal risk (after thousands of PILD procedures), and has benefit (one year data from MILD study), the decision to proceed is clearer. Since MILD and Totalis are

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Gupta, Pragya Title: MD, FRCS, DABPM, CPI
Organization: Advanced Pain Treatment Center
Date: 10/06/2016
Comment:

Image guided Lumbar decomression procedure has helped Significant number of patients of mine who otherwise would have undergone more extensive surgery for restoring their quality of life. This procedure is indicated for patients who have single segmental Central canal spinal stenosis interfering with their activities of daily living and enjoyment of life. The procedure is easily performed in a clinic setting and patients can be discharged Within two hours of the procedure. Typically

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Malinky, Chris Title: MD
Organization: interventional pain management
Date: 10/06/2016
Comment:
The study for MILD met all end points and the results were statistically significant. Another study would be redundant and unnecessary. Thousands of patients have been treated with MILD successfully. Another study would also limit the availability of the procedure for Medicare patients. I have patients that have been waiting for over a year for this procedure. I am not sure why another study of lesser quality is needed to provide positive results of the MILD procedure. I have treated around 50

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Celebrezze, Nicholas Title: State Representative
Organization: Ohio House of Representatives
Date: 10/06/2016
Comment:

On behalf of the more than two million Medicare beneficiaries in my state I am writing to challenge the current draft proposal for the PILD procedure. (Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R). Through my interviews and review of the available data is seems apparent that a preponderance of evidence exists to support coverage for this procedure. Furthermore, the CED process itself seems to be less than well-defined

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Rogers, Eleanor Title: Executive Assistant
Organization: PRECISION SPINE CARE
Date: 10/06/2016
Comment:

September 27, 2016

Tamara Syrek-Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Mailstop S3-02-01
Baltimore, MD 21244

Re: National Coverage Analysis (NCA) for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R)

Dear Ms. Syrek-Jensen:

As healthcare providers in an established interventional pain practice we are writing

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Sirianni, Peter Date: 10/05/2016
Comment:
MILD Is ABSOLUTELY the most effective pain relieving,minimally invasive procedure for patients suffering from spinal stenosis. It is a SAFE efficacious option for those patients who are not surgical candidates or do not desire surgical intervention. Why CMS has not come to this conclusion is completely beyond me given the results in pain relief these patients report. Let's get these patients the treatment they need. Now.
MENKIN, SERGE Title: Medical Director
Organization: Interventional Pain Solutions, PLLC
Date: 10/04/2016
Comment:
Lumbar spinal stenosis due to buckling/hypertrophy of the ligamentum flavum is a very common and disabling problem of the aging. Although majority of patients respond to more conservative treatments, such as PTx and LESI, some require surgical intervention. The conventional surgical technique of removing the ligament and lamina, at times destabilizes the segment, leading to further disability and pain in the future. MILD technique allows for removal of hypertrophied ligamentum flavum

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Brown, Scott Title: Owner
Organization: Altair Biostatistics LLC
Date: 10/04/2016
Comment:

Dear Ms. Syrek Jensen,

As a biostatistician with 15 years of experience in medical device clinical trials, I have had the opportunity to participate in the design, analysis and interpretation of many regulated clinical studies including those in cardiovascular applications, neurology, orthopedics and surgical urology. I have made seven appearances before FDA Advisory Panels representing medical device applications, and am published as a co-author of clinical trial results in

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Li, Sean Title: Medical Director
Organization: Premier Pain Center
Date: 10/04/2016
Comment:

Dear Madam or Sir,

I writing this letter on half of millions of Americans who suffer from chronic pain due to lumbar spinal stenosis.

As a board certified interventional pain medicine physician, I would admit that the treatment for neurogenic claudication due to lumbar spinal stenosis has been challenging due to lack of available treatment options. The development of percutaneous image guided lumbar decompression (PILD) has allowed me and my colleagues to provide new

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Wright, Peter Title: Medical Director
Organization: The Pain Treatment Center of the Bluegrass
Date: 10/04/2016
Comment:
I understand that the ENCORE CED Study for the MILD procedure has completed with the MILD procedure meeting all endpoints at 12 months.
It has been my experience, as well, that the MILD procedure significantly benefited my patients beyond 1 year out. I have many patients that I think to this date would benefit from the procedure.
I therefore respectfully request that the MILD procedure be approved as a Medicare Covered procedure, thereby allowing patients with spinal stenosis

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Harum, Kirk Title: MD
Organization: Crystal Coast Pain Management
Date: 10/04/2016
Comment:
I have performed approximately 50 of the PILD cases. This procedure is very helpful in patient with lumbar stenosis and claudication due to ligamentum flavum hypertrophy. In many cases I was able to treat the patient, who then avoided invasive laminectomy surgery. Overall, the procedure works very well and has improved the quality of life in most of the patients who underwent the PILD procedure. The recent 1-year Outcome data for the ENCORE CED (Coverage with Evidence Development) Study

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Umanoff, Michael Title: MD Director of Pain Medicine
Organization: Total Pain Care
Date: 10/04/2016
Comment:

I have taken this opportunity to express my concern regarding the handling of the MILD procedure by CMS. CMS has chosen not to follow its own policy and instead is subjecting MILD to repetitive and burdensome studies when the data they required has been submitted already. MILD has been extensively studied and the data exists to support full coverage.

Many of my patients are needlessly experiencing a diminished quality of life because there is a gap in treatment options for lumbar

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Coughtry, Brendon Title: Interventional Pain Physician
Organization: Pikeville Medical Center
Date: 10/04/2016
Comment:
I performed greater than 50 MILD procedures and found the results longer lasting and more impressive than any epidural steroid injection or radiofrequency ablation procedure. I would love to have this therapy available again and frequently have patients asking for it.
Woska, Scott Title: Executive Director, NJSIPP
Organization: NJ Society of Interventional Pain Physicians
Date: 10/03/2016
Comment:

The New Jersey Society of Interventional Pain Physicians (NJSIPP) is the New Jersey chapter of the American Society of Interventional Pain Physicians (ASIPP). NJSIPP is an organization that strives to educate physicians about safe, cost effective, high quality interventional pain management techniques and to advocate for and facilitate legislation which will promote access to high quality care for New Jersey citizens. While we have been disappointed in the continued lack of patient access

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Wong, Wade Organization: UCSD
Date: 10/03/2016
Comment:

Comments on CED process for PILD

The recent MIDAS ENCORE study has been completed according to CMS guidelines and the outcomes demonstrate the high level of efficacy and safety that are consistent with 12 previously published studies as well as over 20,000 performed patients, and my own personal experience of over 200 mild patients and my two authored/coauthored studies (Wong W, Clin J Pain 2012 and Schomer D, etal, The Neuroradiological J 2011).

The MIDAS ENCORE study

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Latimore, Martha Date: 10/02/2016
Comment:

I am so glad I found this website and am able to voice my opinion here. [PHI Redacted]

[PHI Redacted] I was made aware of the mild procedure. After learning more about it, I was very hopeful that there was another safe and simple treatment that may help. Those hopes were crushed when I discovered mild was not covered by Medicare.

After further researching your current proposal and this CED process, I have a few questions for your

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Chatas, John Title: MD
Organization: Michigan Pain Specialists
Date: 10/02/2016
Comment:

The MILD procedure should not be subject to further study. It has been shown to be safe and effective. I have performed many of these procedures and it has provided excellent relief to my patients with central canal stenosis with HLF. It greatly improves my patients quality of life, mobility, ability to ambulate, and reduces symptoms of neurogenic claudication. It allows them to walk with less pain, and reduces the use of medications for pain that cause many side effects in the elderly

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Papenfuse, Michael Title: Medical Director and Member
Organization: Comprehensive Pain Specialists, PLLC and Matrix Surgery Center
Date: 10/01/2016
Comment:
I have had extensive experience providing the lumbar decompression procedure for lumbar spinal stenosis and have seen a remarkable positive result for my patients. CMS established the CED process, approved the MiDAS ENCORE CED study, endpoints and outcome measures, and should now follow their own process to render a coverage decision. This therapy provides excellent outcomes for the common debilitating diagnosis, lumbar spinal stenosis, most common in elderly patients. It also provides a

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Bolash, Robert Title: Assistant Professor
Organization: Cleveland Clinic
Date: 10/01/2016
Comment:

Dear Sir or Madam,

I am writing in support of reconsidering coverage adoption for Percutaneous Image-guided Lumbar Decompression, a proven technique for the treatment of back and leg pain in elderly patients with lumbar spinal stenosis arising from hypertrophy of the ligamentum flavum.

In a well-designed 2012 study [Mekhail N, Vallejo R, Coleman MH, Benyamin RM. Pain Pract. 2012 Mar;12(3):184-93.], percutaneous Image-guided Lumbar Decompression demonstrated a reduction

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Hoff, Jeremy Title: Physician
Organization: Hampton Roads Ortho & Sports Med
Date: 09/30/2016
Comment:
It is extremely disappointing to hear that the percutaneous lumbar decompression procedure may have to undergo yet another round of research prior to being approved for commercial/medicare use. I have personally performed many of these when it was initially approved and had excellent outcomes with very minimal recovery time. I also saved medicare tens of thousands of dollars per patient by performing this instead of having the patient undergo a traditional open lumbar decompression. In

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Hawkins, Frank E Title: MD
Organization: Cedar Valley Medical Specialists, Pain Management
Date: 09/30/2016
Comment:

I was fortunate to perform the MILD procedure on several patients prior to it being pulled from the market for further testing. In my experience and our patients outcomes, it provided significant improvements in quality of life measures for individuals who met the criteria to be exposed to the procedure. Many of these individuals require narcotic based analgesic agents but still suffered and had no significant improvement in their ability to perform some basic functions such as walking,

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Boggs, Michael Title: Managing Partner
Organization: Institutional Investor
Date: 09/30/2016
Comment:

I am a venture capital investor and we typically invest $20 - $40 million a year in companies like Vertiflex and Vertos that expect to commercialize FDA approved and cleared products.

We only invest in companies that produce procedures and products that benefit the ecosystem of patients, payors and physicians as that allows for a commercially successful enterprise.

MILD is one of those procedures.

However, a critical aspect of commercialization is unrestricted

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Reitzler, Steve Title: Vice President, Clinical & Regulatory Affairs
Organization: VertiFlex, Inc.
Date: 09/30/2016
Comment:

September 30, 20 16

VIA Electronic Submission

Cheryl Gilbreath, PharmD, MBA, RPh
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850

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

Dear Dr. Gilbreath:

On behalf of Vertiflex, the

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Sills, Shawn Title: Medical Director
Organization: Pain Relief Institute
Date: 09/29/2016
Comment:
The MILD procedure has been effective in treating my patients and many others across the nation. Delaying coverage with further research will only delay important care for patients. Currently, the existing studies are sufficient to recommend coverage. Please reconsider the proposal for further studies.
budnick, linda Date: 09/29/2016
Comment:
[PHI Redacted] I urge CMS to do all it can to expedite access to this procedure for the Medicare population.
Willoughby, Channing Title: M.D.
Organization: Next Step Pain Management
Date: 09/29/2016
Comment:
I am writing to urge the prompt establishment of coverage for the MILD procedure. Having been an early adopter of this therapy, I have seen first hand the positive impact it has offered to those with neurogenic claudication.
The MIDAS study has provided convincing evidence and provides quality level 1 data to show efficacy of this procedure. It is my belief that the proposed cohort study will only yield a lower quality of evidence and further delay this valuable treatment option from

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Datta, Samyadev Title: M.D.
Organization: Center for Pain Management
Date: 09/29/2016
Comment:
As a board certified Pain Specialist, Board Certified Aneshtesiologist, and a Fellow of the Royal College of Anaesthesiology of England, I am writing to express my displeasure with the proposed decision on MILD. I was an early adopter of the minimally invasion lumbar decompression (MILD) procedure and performed about 120 cases on patients with neurogenic claudication from hypertrophic ligamentum flavum. I was very satisfied with the outcome in those cases with nearly 80% having positive

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Kaufman, Andrew Title: M.D.
Date: 09/29/2016
Comment:
This procedure, MILD is an important tool in the ability to provide patients who maybe non surgical candidates relief from pain associated with spinal stenosis.
The current study information clearly shows efficacy as well as safety.
As one who had performed MILD procedures previously, on patients who's average age was 79, I saw first hand the profound relief that occurs after.
All of the cases were vetted by nuerosurgeons who had stated that due to multiple issues they were

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Jiha, Jihad George Title: MD
Date: 09/29/2016
Comment:
CMS should follow its own policy of the CED study. By not doing so, it is losing its credibility and and is stifling innovation which made this country the leader in medical and technological advances that lead to finding cures and improving people's lives.
Guernelli, John Title: MD
Organization: MidCoast Hospital
Date: 09/29/2016
Comment:
Minimally invasive lumbar decompression has been well studied and was the only option for patients not considered surgical candidates suffering from back and leg pain due to spinal stenosis. These patients now receive endless epidural injections, therapy and opioid medications....does this make any sense? Further study is welcome but the procedure is highly effective in well selected patients now. Outcomes in my practice noted about 60% excellent response with NO FURTHER TREATMENT NEEDED.

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Hoelzer, Bryan Date: 09/28/2016
Comment:

I am writing this comment in response to the CMS proposal that minimally invasive lumbar decompression (MILD) be covered only within another study environment. In 2014 CMS mandated a multisite, randomized control trial to compare MILD to lumbar epidural steroid injections for spinal stenosis. With input from CMS this trial was conducted in a thoughtful, scientific, and controlled manner. All primary and secondary endpoints were met and showed MILD to be superior to a treatment commonly

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Anitescu, Magdalena Title: MD, PhD, Associate Professor
Organization: University of Chicago Medicine, Departmemtof Anesthesia
Date: 09/27/2016
Comment:
I have used the MILD procedure and had very good success with it.
there are a significant number of patients, primarily older, with significant co-morbidities who have calcified ligamentum flavum, DDD and DJD and are severely debilitated by neurogenic claudication, pain in legs, posterior aspects of thighs especially with movement; those patients are not candidates for surgery and have significant side effects from opioids; MILD is the perfect procedure for these patients; offers a viable

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Leahey, Mark Title: President & CEO
Organization: Medical Device Manufacturers Association (MDMA)
Date: 09/27/2016
Comment:

Dear Ms. Syrek Jensen,

On behalf of the Medical Device Manufacturers Association (MDMA), I would like to thank you for the opportunity to comment on this draft policy. The Medical Device Manufacturers Association (MDMA) is a national trade association based in Washington, DC providing educational and advocacy assistance to innovative and entrepreneurial medical technology companies. Since 1992, MDMA has been the voice for smaller companies, playing a proactive role in helping to

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Bosscher, Hemmo Title: MD
Organization: Hemmo Bosscher Painmanagement MD Grace Health System
Date: 09/27/2016
Comment:
Having treated over 100 patients using PILD it is obvious that this procure is a rest of life changing intervention of much higher proportion than let say spinal cord stimulation or open surgical decompression. And it is much much cheaper.
How am I going to tell my many patients, disabled with spinal stenosis, that I can help but they must wait longer? They already have waited three years! Some will never benefit from it. Maybe your mom or dad.
McRoberts, William Title: Medical Director, Neurosurgery, Spine and Pain Med
Organization: Holy Cross Hospital, Fort Lauderdale, FL
Date: 09/27/2016
Comment:

As you know, most patients facing lumbar spinal stenosis LSS face a compendium of options which are either largely ineffective or fraught with great risk. Most patients in this age category understand their options quite well. Living with the pain and disability is extremely dangerous as disability and the inability to walk portends an early death and increased morbidity shown by literally hundreds of studies over decades of research . Simply stoning this aging group with opioids is

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Laub, Ronald Title: MD
Organization: Colorado Springs Interventional Pain Management
Date: 09/25/2016
Comment:

Ronald M. Laub, MD
Interventional Pain Management
3030 N. Circle Dr. #210
Colorado Springs, CO 80909

September 25, 2016

Re: MILD/PILD decision

To Whom It May Concern:

As an Interventional Pain Physician with over 40 years of experience treating patients who have Lumbar Spinal Stenosis (LSS) with neurogenic claudication, I appreciate this opportunity to express my dismay over the recent CMS draft decision regarding coverage for

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Mekhail, Nagy Title: Director, Evidence-Based Pain Management Research
Organization: Cleveland Clinic, Cleveland, Ohio
Date: 09/24/2016
Comment:

Dear Ms. Syrek Jensen

Thank you for the opportunity to comment on the recently posted draft NCD. I currently hold a joint appointment at the Cleveland Clinic Pain Management Department and the Cleveland Clinic Center for Spine Health . I am also Professor of Anesthesiology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve and the director of Evidence-Based pain management research at Cleveland Clinic. I am also the former Chairman of the Pain Management

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Benyamin, Ramsin Title: Medical Director
Organization: Millennium Pain Center
Date: 09/22/2016
Comment:

Thank you for the opportunity to comment. I am the MiDAS ENCORE principal investigator and paper author along with my colleague Dr. Peter Staats. I am shocked by this decision and ask CMS to change their position to a coverage decision without the need to do a prospective cohort study. The CED process is intended to develop evidence to support a coverage decision. This was done with MiDAS ENCORE…a protocol that was approved by CMS. Success should be determined by achievement of a priori

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Dragovich, Anthony Title: Partner Blue Ridge Pain Management
Date: 09/22/2016
Comment:
Percutaneous image guided lumbar decompression for lumbar spinal stenosis is a valuable and needed tool for physicians. We currently do not have any comparable procedure. Epidural steroid injections provide short-term relief and have a downside of side effects of steroids. Lumbar decompression has potential surgical complications and is a much more invasive procedure. I performed percutaneous image guided lumbar decompressions while I was in the army. The procedure was very effective wit

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Garcia, Eduardo Title: MD
Organization: Space City Pain Specialists
Date: 09/22/2016
Comment:

Many of my current patients are CMS beneficiaries that are suffering from Lumbar Spinal Stenosis with Neurogenic Claudication symptoms caused by Hypertrophic Ligamentum Flavum. Having performed multiple mild procedures in the past, I knew PILD was the most effective, least invasive and a very cost friendly treatment option for these patients. Many of these patients have been waiting 3+ years for an effective treatment option other than surgery to be made available to them.

When

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Deer, Timothy Title: President
Organization: West Virginia Society of Interventional Pain Physicians (WVSIPP)
Date: 09/21/2016
Comment:

The West Virginia Society of Interventional Pain Physicians (WVSIPP) is dedicated to providing cutting edge education, information and support to physicians and clinicians treating patients in pain. We are a West Virginia society with national and international reach and we are a certified and sanctioned branch of the American Society of Interventional Pain Physicians (ASIPP). Our board members include international thought leaders in interventional pain management and physical medicine and

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Winkley, James Title: Dr
Organization: Firsthealth Back and Neck Center
Date: 09/21/2016
Comment:

The mild procedure is an effective treatment for elderly patients with neurogenic claudication. I have personally performed more than 50 procedures and had excellent improvement in more than 70% of my patients and moderate improvement in the other 20%. No complications. This is an excellent modality that needs medicare coverage to care for our patients.

There is no need for another study. There have already been 12 studies all showing efficacy and the ENCOre study met all the

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Dunteman, Edwin Title: M.D.
Organization: A&A Pain Institute of St. Louis, Elpis Pain Management Center
Date: 09/21/2016
Comment:

I am a Board Certified, Fellowship Trained Pain Management specialist with approximately 25 years of experience, with significant experience treating low back pain. I am writing to give support for CMS to cover for the MILD procedure, rather than mandating a redundant RCT, which will not add significantly to the published body of knowledge regarding the efficacy of MILD procedures for patients with painful spinal stenosis. The prior study mandated by CMS supported multiple previously

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Cosgrove, Michael Title: Pain Specialist
Organization: TOC Huntsville
Date: 09/21/2016
Comment:
I performed about a dozen cases without complication. some progressed to open decompression for only transient improvement of symptoms, but 75% had good immediate relief which was enduring. A valuable therapy.
Parker, Edson Title: MD
Organization: Veterans Administration Healthcare System
Date: 09/21/2016
Comment:
I have been using the Vertos MILD Percutaneous Lumbar Decompression Device to treat my patients, all military Veterans, with spinal stenosis since 2011, having performed the procedure on over 80 patients. It is a very safe and effective procedure, I have had excellent results and no complications. It is especially useful for elderly patients or those with significant medical problems who should not undergo general anesthesia for an open spine surgery procedure. It should have been approved

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Paquette, Brian Title: DO, MPH
Organization: Indiana Polyclinic and JWM Neurology
Date: 09/20/2016
Comment:
In the right hands, this procedure improves LSS patient function considerably. I have performed this procedure extensively and it far exceeds lumbar epidural steroid injections and has obviated the need for surgery in all cases. The outcome of the MiDAS ENCORE is not surprising (positive with regard to all endpoints). What is surprising is the committee's decision to continue to withhold reimbursement for PILD. Let's stop withholding important treatments for our population, this needs to

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Burfeind, Rebecca Title: Dr
Organization: Pain Management Associates
Date: 09/20/2016
Comment:
I have performed this procedure on many patients with lumbar spinal stenosis, that was considered non-operative due to age or co-morbidities. My patients have done extremely well with this procedure, affording them reduced pain and improvement in level of functioning. I ask CMS to reconsider approving Percutaneous Image-guided Lumbar Decompression for your Medicare beneficiaries.
Singh, Amit Date: 09/20/2016
Comment:

The studies have shown time and again that MILD can be safe and effective. Regarding the lack of concensus for diagnostic criteria as it relates to LSS and neurogenic claudication, this reservation can be applied to the current approved treatments.

IN contrast to decompression surgeries, Mild can be effective and surgery is still an option if not effective.

It should be covered to provide safe and effective care for patients.

Bassam, Deeni Title: Director of Non-Operative Spine Services
Organization: The Spine Care Center
Date: 09/19/2016
Comment:

Patients with severe spinal stenosis caused by ligamentum flavum hypertrophy have woefully few options to relieve their pain and disability. The neurogenic claudication symptoms of SS significantly limits mobility leading to increased utilization of mobility devices such as canes, walkers, and wheelchairs. Currently these patients suffer a slow and painful course leading many to opt for major surgery which is replete with risk. I have performed the MILD procedure on over 25 patients and

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Gharibo, Christopher Organization: NY State Society of Interventional Pain Physicians
Date: 09/19/2016
Comment:

As stated in our previous comment, our Society of Interventional Pain Physicians supports the process of researching and validating novel technologies to provide the safest, most clinically effective, least invasive, and most cost effective procedures and treatments for our patients. We appreciate the opportunity to comment on the proposed decision memo, or draft coverage policy for the MILD Procedure. The mild procedure has a large body of high quality research that demonstrates the

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Choi, Daniel Title: MD
Organization: Valley Pain Consultants
Date: 09/19/2016
Comment:
I am writing in response to the recent decision regarding the above procedure. I am an interventional pain specialist who has been using the therapy to help patients in the past and who also participated in the recent study as a principal investigator. I feel the decision to limit the use of the procedure within the context of another study needs to be reconsidered. The current study was well conducted, meeting all the requirements stipulated by CMS. The results are favorable and

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Lipman, zachary Title: MD
Organization: Interventional Pain Solutions
Date: 09/19/2016
Comment:
I performed 20 or so of these procedures and I found the procedure to be 100% safe. The procedure was very effective at relieving pain in patients who had severe pain while walking or standing (neurogenic claudication). I only performed this procedure in patients who were not good surgical candidates. I was very disappointed that the procedure was taken away from this patient population.
Cano, William Title: MD
Organization: Director, Pain Medicine Service, PMSI
Date: 09/19/2016
Comment:
I have performed the MILD procedure on many of my patients in the past and I have found it to be extremely helpful in relieving the leg pain associated with ligamentum flavum hypertrophy-caused spinal stenosis. It would be very helpful if Medicare allowed me to get reimbursement for this procedure since a large portion of my patients suffer from spinal stenosis secondary to ligamentum flavum hypertrophy.
Thank you.
Rutledge, John Title: MD
Organization: Austin Radiological Association
Date: 09/19/2016
Comment:
MILD used appropriately, significantly moderates stenosis pain and has been very useful in my patients who were not candidates for open lumbar decompression and fusion. In our series, we have had no complications.
Lippert, William Title: MD
Date: 09/19/2016
Comment:
I have done many Mild procedures and the outcomes have been largely positive. Many patients have had dramatic outcomes and have had no need to proceed to surgical decompression and have enjoyed a much improved functional status. The Encore Study mirrors my experience with Mild and given the positive results of several other studies as well, I would highly encourage allowing the procedure back into mainstream pain care. Many of our elderly or ill patient's who are not candidates for open

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Bojrab, Louis Title: Physician
Organization: Michigan Pain Specialists
Date: 09/18/2016
Comment:
PILD is a procedure that is more safe than our existing treatments for spinal stenosis, while providing equal or better results than the existing treatment. It is imperative that you please allow this to be covered for all Medicare recipients now.
The research has been done with all primary and secondary endpoints met, that was requested by CMS.
The "Prospective Cohort Study" that you have requested is unnecessary, and is delaying this valuable treatment for my patients. Please

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Seitzman, Howard Title: Medical Director Atrium Pain Department
Date: 09/18/2016
Comment:

I am writing in support of the MILD procedure for patients with spinal stenosis and neurogenic claudication. This has been a very well-studied procedure with good out-comes. Others writing in support of this procedure have quoted the literature, which is impressive. I will not repeat that here.

I am not an academic, but a regular, everyday practitioner who sees these patients every day.

While the MILD procedure had coverage, I performed about 75 MILD procedures

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Moss, John Title: Physician
Date: 09/18/2016
Comment:
I have found this procedure to be of benefit in the appropriate patient population. I have had several patients who have benefited from the procedure and avoider more invasive operations.
Giroux, Guy Title: MD
Organization: St Francis Health Center
Date: 09/18/2016
Comment:
The MILD procedure was very helpful for many of my patients. Some of these patients had several other conditions, heart disease, COPD, that made them poor candidates for conventional open back operations. I'm hoping that the procedure will become available for my patients in the near future again.
Kloc, Ronald Title: Pain Physician
Organization: Mason City Clinic
Date: 09/17/2016
Comment:
I performed the MILD procedure in 44 patients when it was initially approved. My patients had at least 50% improvement in their pain approximately 80% of the time. My patients were relieved that something could be done for their debilitating spinal stenosis when they were otherwise too old or had too many co-morbidities for surgery.
lichota, lisa Title: DO
Date: 09/17/2016
Comment:
MILD was a GREAT procedure for the right patients. Patient selection is quite important. I cared for many patients with this when it was an option and it covered a need NOT met otherwise, Many older patients with spinal stenosis are not good operative candidates due to co-morbidities. I think it would be a great benefit to patients to allow for this procedure
Kloth, David Title: President
Organization: Connecticut Pain Care
Date: 09/17/2016
Comment:

I am providing comments regarding CMS’s recent draft coverage proposal for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R). This procedure has recently been studied through the CMS CED process as outlined by CMS and agreed to by CMS. Despite excellent study results CMS has not granted coverage (or even coverage with specific restrictions) delaying and denying access to this important minimally invasive treatment for patients. Candidates for less

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Ky, Paul Title: D.O.
Organization: Advanced Pain Solutions
Date: 09/17/2016
Comment:

Dear CMS Committee Evaluators:

It is my opinion that patients have tremendously benefited from the MILD procedure. Patients who are afflicted with neurogenic claudication from central & lateral recess lumbar spinal stenosis have received very good to complete pain relief from this technology. Greater than 90% of those patients still continued to benefit from the procedure in terms of pain score as well as improved ADLs.

I implore you to make appropriate & sensible

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Wu, Thomas Date: 09/17/2016
Comment:
More tools available for patients = net patient benefit. Having seen patients benefit directly from this procedure, it was somewhat unexpected to see it being pulled from the commercial marketplace. There is a definite subset of patients who will benefit from this much less invasive procedure instead of being forced into the laminectomy/fusion option. At the very least, it deserves more research to prove its efficacy and per cost benefit for patients and the healthcare system overall.
Weiss, Howard Title: MD
Organization: Medical Pain Management Services
Date: 09/16/2016
Comment:
This procedure offers a significant chance of quality of life changing improvement in the elderly population with ligamentum flavum hypertrophy and neurogenic claudication. They usually have no other surgical option. MILD is inexpensive and low risk. It is criminal to deprive our seniors of the oportunity to benefit from this procedure.
Nieves-Ramos, Ricardo Title: M.D.
Date: 09/16/2016
Comment:
The MILD procedure was a very effective one for select patients that had spinal stenosis secondarily due to ligament flavum hypertrophy and were not candidates for surgery. I had great success with my past patients that had this procedure and have found many patients that would benefit from this procedure unfortunately you have not allowed it to be covered by insurance and so they are unable to afford this helpful procedure.
Bhaskara, Sri Title: MD
Date: 09/16/2016
Comment:

MILD is an inexpensive, safe, effective alternative to spine surgery.

Procedure has been effectively performed on medicare recipients with immediate relief of pain and weakness o the legs.

Government operations are usually delayed, biased, ineffective, inefficient and expensive. I am not surprised that it has taken so long for CMS to take a stand regarding MILD procedure.

Lobbying by spine surgical companies is the only reason I believe that MILD procedure is

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Tsao, George Date: 09/16/2016
Comment:
this procedure is a very effective lower back pain reducing procedure on multiple co-morbidities patients who has spinal stenosis with neurogenic claudication and ligamentum flavum thickening.
Johans, Thomas G Title: MD
Organization: WAAI
Date: 09/16/2016
Comment:

To whom it may concern:

I am writing to show my support in allowing Medicare payment for the MILD procedure. I was one of the early physicians trained and used this modality in my practice for those patients suffering from radicular leg pain secondary to spinal stenosis formed from a hypertrophied ligamentum flavum. For this indication, the MILD procedure was outstanding! I was very disappointed that Medicare refused to support and allow payment for the MILD.

This

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Luh, George Title: MD
Date: 09/16/2016
Comment:
Percutaneous Image-guided Lumbar Decompression aka MILD procedure is in my opinion a great alternative for patients with severe low back pain and lower extremity pain. I have performed approximately 50 of these procedures and the majority of my patients have improved. Importantly, most of my patients had no other alternative. They were not surgical candidates. None of my procedures had any complications. There are numerous published trials demonstrating the safety and efficacy of this

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Hayek, Salim Title: MD, PhD
Organization: University Hospitals Cleveland Medical Center
Date: 09/16/2016
Comment:
PILD is an effective modality for managing patients with lumbar spinal stenosis, mostly due to hypertrophy of the ligamentum flavum, not only in clinical practice but also based on a randomized control trial that recently evaluated the therapy compared to epidural steroid injections. The study (Benyamin, R., et al. (2016), mild® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial, Pain Physician, 19: 229-242, ISSN

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Simopoulos, Thomas Title: Director of Pain management
Organization: Beth Israel Deaconess Medical School
Date: 09/16/2016
Comment:
The treatment of spinal stenosis remains a very challenging entity in the elderly especially with advanced medical comorbidities. Medications can be with significant side-effects and complications. At the same time, the pain of this condition does not respond well to any particular class of medications. Physical therapy may lead to unsatisfactory results in many patients. Though many patients can find relief with epidural steroid injections, there are an equal number that do not respond in a

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Konen, Andrew Title: M.D.
Organization: Baylor University Medical Center
Date: 09/16/2016
Comment:
The MILD brand of percutaneous lumbar decompression was the only minimally invasive method that was successful, reliable, and available for any patient that qualified for spine injection procedures.
It saved several dozen of my personal patients from invasive and destructive lumbar surgery. I am disappointed and appalled that it was abruptly dropped as a reimbursable code.
Grigsby MD, Eric Title: CEO
Organization: Neurovations Clinical Research
Date: 09/16/2016
Comment:
I'm writing in support of national coverage for minimally invasive lumbar decompression for spinal stenosis. This technique has been studied extensively with excellent safety data, and efficacy data better than the current clinical alternatives. The recent CED study apparently met its safety and efficacy endpoints, demonstrating superiority to the clinical comparator. We are all trying to find alternatives to back surgery and to continued use of opiates, and badly need this sort of safe,

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Mazloomdoost, Danesh Title: Medical Director
Organization: Pain Management Medicine
Date: 09/16/2016
Comment:
I am writing to advocate for mild coverage. From an interventional standpoint, we have a spectrum of sustainable options for the varied causes of low back except when it comes to spinal stenosis and neurogenic claudication. In my experience ESI are effective acute interventions with transient effects but the long-term impact is marginal if any. This condition affects primarily my geriatric population for which few options exist: opioid management increases the risk of falls, fractures, altered

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Harned, Michael Title: MD
Date: 09/15/2016
Comment:

mild is a minimally invasive interventional pain procedure which has helped thousands of patients will very minimal risk. To date there have been several studies documenting its safety. In 2016, a study was published documenting its superiority to epidural steroid injections for lumbar spinal stenosis. Epidural steroid injections are performed every single day for stenosis but we need additional treatment options. I have personally performed mild prior to the CMS ruling and had

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Cabaret, MD, Joseph A. Title: President
Organization: California Society of Interventional Pain Physicians
Date: 09/15/2016
Comment:

I’m writing on behalf of the California Society of Interventional Pain Physicians (CASIPP) and asking that CMS reconsider its recently posted draft decision on the mild® procedure. As an active participant throughout the CED process I’ve read the draft and find myself wondering what exactly CMS is doing. I’ll admit that while disappointed in the initial decision to put mild into the CED process, as I’ve seen first-hand the positive effects that the procedure can have a patient’s

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Anderson, Anthony Title: MD
Date: 09/14/2016
Comment:

My name is Dr. Anthony Anderson. I Johns Hopkins fellowship trained pain physician with over 25 years of experience in treating spine patients.

I have treated over 100 patients with MILD and have seen the benefits of this therapy in my patients. I am writing to request that you change this policy to a positive coverage policy without the requirement for a prospective cohort study. Your proposed prospective cohort study is limited to investigators from the CMS RCT study, which

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Fotopoulos, Constantine Title: MD
Date: 09/14/2016
Comment:

I am concerned about the prospects for future innovation and advances in patient care, in light of a decision like this.

MILD has been studied for nearly 10 years – most recently in the context of a CMS prescribed and approved NCD. Over 20,000 patients have been treated, with myself having preformed over 200 of these procedures. The procedure has broad support from the societies representing the treating physicians.

This decision is deeply concerning. It is

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Wahezi, Sayed Emal Title: Program Director, Pain Medicine Fellowship
Organization: Montefiore Medical Center
Date: 09/13/2016
Comment:

Thank you for the opportunity to comment. After participating in CMS-designed MiDAS ENCORE Study, reviewing the recently published study data and reflecting on my personal experience with the MILD Procedure, I am shocked and in complete disagreement with the suggested coverage policy.1-3 The outlined policy will further limit patient access and produce lower quality, replicative data to what already exists. As providers, we strive to provide optimal care to our patients; limiting new and

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Staats, Peter Title: MD MBA
Organization: Premier Pain Centers
Date: 09/13/2016
Comment:

Dear Ms. Syrek Jensen,

My name is Peter Staats and I am a board-certified physician specializing in pain medicine. I also serve as an Adjunct Associate Professor at Johns Hopkins University School of Medicine where I was the founder of the division of pain medicine. I am the author of over 200 articles, book chapters and abstracts on the science of pain medicine. I have authored or edited 7 books on pain management. I am one of the principal investigators for the CMS Study

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Lingreen, Richard Title: MD
Organization: Commonwealth Pain Specialists
Date: 09/13/2016
Comment:

Dear CMS,

As an investigator that has done well over 44o PLID procedures I was underwhelmed at your proposed response for the multi-year investigation that we undertook at your request and with your instruction. I humbly ask that you revisit your response and make the procedure more accessible to the general patient population. We have proven that PLID meets the criteria for public good and exceeds the standard in comparison to the chosen procedure of epidural injection as well

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Grider, Jay Title: DO, PhD, MBA Professor
Organization: University of Kentucky
Date: 09/13/2016
Comment:

My name is Jay S. Grider DO, PhD, MBA and I am a Professor of Anesthesiology and Medical Director of the Pain Services at UKHealthCare. I’m writing to express my disappointment and disagreement with CMS’ proposed ruling on MILD. As an author of one of the early studies on MILD (non-industry sponsored by the way) I am very familiar with the safety and efficacy of the procedure in clinical and investigational settings. Quite frankly, I’m having a difficult time reconciling the decision

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Haladjian, Razmig Title: MD
Organization: Michigan Interventional Pain Center
Date: 09/13/2016
Comment:

September 13, 2016

Razmig Haladjian, MD
Director; Michigan Interventional Pain Center – 2006-present
19725 Allen Road – Bldg. 1 – Ste A
Brownstown, MI  48183
American Board of Anesthesiology - 2006
Diplomate Pain Medicine - 2007
American Board of Addiction Medicine - 2012
Director: Pain Management Fellowship; Wayne State University School of Medicine
Clinical Assistant Professor; Wayne State University School of Medicine

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Yousaf, Muhammad Title: MD
Organization: CAVHS
Date: 09/13/2016
Comment:

Dear Ms. Syrek Jensen

As an interventional neuroradiologist based at the VA in Little Rock, Arkansas, I have personally witnessed the significant benefits of MILD for hundreds of our Veterans. Having performed over 300 MILD procedures, I am one of the most experienced users of the MILD procedure. These benefits have been consistently observed and reported in over 20 published articles and 12 clinical studies. Most recently, Benyamin and Staats published one-year follow-up for

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Richardson, William Title: MD
Organization: Southeastern Spine Institute
Date: 09/13/2016
Comment:

Dear Ms. Jensen,

Thank you for the opportunity to comment. I participated in the MILD Encore Randomized Control Study as one of the site principle investigator. The randomized study has provided the strongest clinical efficacy and proof of benefit for patients that suffer from Lumbar Decompression for Lumbar Spinal Stenosis (LSS) thus far. There has been many other studies conducted with similar results. I believe there is more than sufficient evidence that this therapy

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Chartier, Gavin Title: MD
Date: 09/13/2016
Comment:

My name is Dr. Gavin Chartier and I am an Interventional Pain Physician from Vincennes, IN. I am commenting to express my concern and resistance to the draft policy on the mild® Procedure.

I was an investigator in the MiDAS ENCORE CED Study and have been performing the mild procedure since 2011. To date, I have treated approximately 125 patients with the mild procedure. The outcomes for patients treated with mild in my practice have mirrored the clinical data

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Golovac, Stanley Title: Medical Durector of Surgery Partners
Organization: Surgery Partners
Date: 09/13/2016
Comment:

My is Stanley Golovac, I am a senior instructor and very experienced physician. I have personally performed over 285 MILD cases with an improvement rate of over 85 % I have personally participated in 3 of the clinical trials proving the efficacy of this unique procedure. I appreciate CMS opening PILD up for reconsideration. This is a well-established therapy and I have many patients that fit the criteria and would clearly benefit from this procedure. I have reviewed your posted draft

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Waling, Joseph Organization: Joseph F Waling MD PC
Date: 09/12/2016
Comment:

Dear Ms. Jensen,
I am writing on behalf of all my colleagues at Deaconess Comprehensive Pain Center. We are extremely disappointed in the proposed draft decision for the PILD procedure. I participated as an investigator in the MIDAS ENCORE Randomized study, which was approved by CMS with specific study endpoints designed to provide the necessary information needed to make a coverage decision. Study sample size was powered to test for superiority. the data generated in this study met

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chafin, timothy Title: md
Organization: Vidant Roanoake Chowan Hospital
Date: 09/12/2016
Comment:

Thank you for the opportunity to provide a comment on the National Coverage Analysis for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R). I began performing PILD, specifically the MILD Procedure, in 2011 and have treated over 900 patients. I strongly disagree with the proposed decision memo and urge CMS to revise the policy to provide unrestricted patient access to the MILD Procedure. The level of scrutiny the MILD procedure has been under is

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Paicius, Richard Title: MD
Organization: Newport Beach Headache and Pain
Date: 09/12/2016
Comment:

As a principal investigator in the MiDAS ENCORE randomized controlled CED study, I was astonished by CMS’s proposed decision to require yet another CED study. Over the last 2 years, my colleagues and I have made a substantial commitment of time and resources for the purpose of completing the CMS-approved ENCORE Level 1 CED study. The ENCORE study was completed successfully, and the statistical superiority of MILD was demonstrated for all primary and secondary endpoints as reported by

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