Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis

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 introduction of new medical technology from our members. MDMA believes that Medicare coverage for new medical technologies which satisfy the requirements of the 510(k) or PMA process of the Food and Drug Administration, should have coverage established either through local Medicare Contractor policy discretion or through coverage with evidence development (CED). Our members understand the importance of relevant clinical evidence supporting the efficacy of their product and are continuously collecting evidence to improve patient care by conducting clinical research that adds value and knowledge to the current body of evidence. Our members partner with trained physicians and other healthcare practitioners to develop appropriate data collection and patient selection criteria.

We understand that CMS maintains the authority to use different approaches to cover a device requiring further development of evidence. We also understand that CMS can determine under what criteria a patient can have access to a technology. We encourage CMS to continue to evaluate new technologies for select patient populations and pre-determined conditions. However, we encourage CMS to continue to cover procedures associated with emerging technologies either through local Contractor discretion or through CED. The establishment of national non-coverage decisions under most circumstance for new technologies could impact companies from developing technologies that may offer tremendous advances in medical science and life-saving technologies.

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

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

The North American Spine Society (NASS) is a multidisciplinary medical organization dedicated to fostering the highest quality, evidence-based and value-based, ethical spine care by promoting education, research and advocacy. NASS is comprised of more than 8,000 spine care providers from several disciplines including orthopedic surgery, neurosurgery, physiatry, neurology, radiology, anesthesiology, research and physical therapy.

NASS appreciates the opportunity to comment on CMS’s proposed decision memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (PILD), and this is an updated comment following our prior response dated May 3, 2013. Our comment is based on updated studies for percutaneous image-guided lumbar decompression (PILD), a minimally invasive laminotomy/laminectomy procedure (interlaminar approach) for decompression of the lumbar spine for lumbar spinal stenosis (LSS) under indirect image guidance (e.g. fluoroscopic, CT) with or without the use of an endoscope. This is a technique is not an open surgical approach and is currently described by CPT codes 0274T.

Previously, the North American Spine Society recommended further study of this promising procedure but did not recommend coverage for this as an alternative to ESIs or as an alternative to open laminectomy. However, given the number of new studies and publications noting the safety and efficacy of the procedure, we would like to revise our recommendation. With this new technology, strict indications must be set and observed. Until better comparative data is available, we recommend coverage on a case-by-case basis where indications are met and value may be predicted. We are submitting our change in position for a number of reasons as noted below.

First, the approval or denial of a procedure should be based solely on the merits of the procedure. The decision to rationalize the effectiveness of the procedure based on the diagnosis is somewhat puzzling. While there may be some ambiguity to what defines lumbar stenosis on an imaging study, the fact is, as physicians we treat patients and not imaging studies. The imaging studies are used only as confirmatory procedures once we have seen and examined the patient. At NASS, many hours have been spent developing guidelines related to lumbar stenosis and we suggest the definition we have provided in these documents is appropriate: Degenerative lumbar spinal stenosis describes a condition in which there is diminished space available for the neural and vascular elements in the lumbar spine secondary to degenerative changes in the spinal canal. When symptomatic, this causes a variable clinical syndrome of gluteal and/or lower extremity pain and/or fatigue which may occur with or without back pain. Symptomatic lumbar spinal stenosis has certain characteristic provocative and palliative features. Provocative features include upright exercise such as walking or positionally-induced neurogenic claudication. Palliative features commonly include symptomatic relief with forward flexion, sitting and/or recumbency.

Secondly, determination that there is a “lack of consensus on the treatment of LSS,” somehow influences the determination of whether PILD is effective does not seem to make much sense. For the most part, all spine conditions “lack a consensus on the treatment,” the reasons for this are typically because of the varying degree of symptoms related to the pathology, the overall health of the patient, and the treatments and technology available to us to treat the condition. We practice as physicians, not as robots or computers where diagnosis A always gets treatment A, and diagnosis B gets treatment B. Patient’s whom we treat present with varying degrees of impairment based on their diagnosis and need individualized treatment based on their symptoms. A patient with moderate low back and leg pain and no weakness related to a lumbar disc herniation may be an excellent candidate for a lumbar epidural steroid injection, while another patient with a lumbar disc herniation may require more urgent surgery because of substantial weakness and the presence of bowel or bladder changes. The diagnosis is the same, but the treatments we may choose vary. The same is true with lumbar spinal stenosis.

The next argument against PILD is that there is not sufficient data to support that decompression of the canal occurs on imaging studies. This seems to contradict the first argument, that there is no consistent diagnosis of lumbar stenosis based on the degree of radiographic narrowing. We believe that your assessment is correct, there is not sufficient evidence showing adequate or inadequate decompression of the canal. Further, the imaging requirement should be irrelevant. While one would expect to see evidence that the procedure has opened the canal to some degree, the real interest in any study is how is the patient clinically doing? Expecting authors to obtain cross-sectional imaging following a study is needlessly expensive, particularly if the patient’s symptoms have improved.

The final argument against PILD is the most relevant and in our estimation, the one that should or should not justify the procedure. We agree that the current body of evidence addressing the PILD procedure is of low quality. The PILD procedure does appear to be a relatively safe procedure for the treatment of symptomatic lumbar spinal stenosis. Outcome data suggest that the procedure provides statistically significant reductions in pain intensity and statistically significant improvements in function, but the data, which are continuous rather than categorical, suggest that these improvements do not meet some definitions of a minimally acceptable outcome in all patients.

Our recommendation at this time is that CMS refrain from making a final decision regarding the utility of this technology, which is potentially promising in a select group of patients. Our hope is that future studies will be conducted which will provide categorical data that will clarify the proportions and characteristics of patients who are most likely to benefit from the PILD procedure, and the degree to which these patients benefit. Additional studies, independent of industry funding and involvement, are needed. Data at time frames greater than one year, which are clearly lacking, and additional data at up to two years, would be beneficial in determining the overall utility of the procedure. Ideally, predictive factors could be identified to help differentiate which patients are most likely to have a positive or negative response to this procedure.

NASS believes that it is premature to deny the coverage of PILD based on limited research and would like to request CMS to consider including this procedure for further discussion under “Coverage for Evidence Development” category until more data is collected and have sufficient evidence available to determine the utility of this procedure.

We hope that this information will assist in formation of a reasonable coverage policy.

Sincerely,

William Watters III, MD
President, North American Spine Society

References:

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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. ASIPP does not support the draft analysis and urges CMS to issue a favorable National Coverage Decision. There are several concerns raised in the NCA draft that relate to pain studies in general, the data for the mild procedure, and LSS treatments that we would like to address.

Lack of consensus on diagnostic criteria

The NCA expressed a concern over diagnostic criteria for LSS treatments in general and applied that concern to the studies conducted on mild. The NCA cited studies such as Sandella, et al. which stated that “There is no “gold standard” for diagnosis and treatment of stenosis because of variable signs and symptoms, physicians’ history-taking and physical methods and diagnostic tests” and concluded that “Given the many conditions that lead to complaints of back pain, the consistent application of explicit and reproducible diagnostic criteria are needed to assure that patients in clinical trials are comparable to patients in community settings who may be labeled with the same diagnosis but who may have other causes of back pain.” (1)

We disagree with this characterization as it applies to PILD and also disagree with the foundation used to arrive at this conclusion. The NCA’s conclusions and cited studies refer to general categories of “back pain” and “LSS” and it is unclear from these studies whether the researchers were referring to all LSS or LSS with neurogenic claudication and hypertrophic ligamentum flavum, which is what PILD treats. This is important because neurogenic claudication has a clearly understood symptomatic diagnosis. The symptoms are a limitation in the ability to stand or walk for extended periods of time due to pain/numbness in the back or legs and the discomfort is relieved with flexion. The same source listed by the NCA (Sandella) actually indicated that a physician can become “almost 90% certain a person has clinical spinal stenosis” within 5 questions. The top 3 questions were “leg pain while walking” (66%), “must sit down” (66%), and “flex forward while walking” (49%). It is not clear whether the other studies cited by the NCA specifically looked for neurogenic claudication symptoms. For example, Haig et al. identified patients that experienced back pain after a 15 minute ambulatory test but it is unclear whether the test included a measure to determine whether pain was relieved upon flexion or sitting, which is a key component on neurogenic claudication identification (2). Kurd analyzed patients from the SPORT study, whose enrollment criteria included patients with neurogenic claudication AND radicular pain (3). De Graaf, et al. did not restrict their systematic review to studies that looked at neurogenic claudication (4). As a matter of fact the de Graaf study looked at publications that included central, lateral, and foraminal stenosis with no limitation to the causes of the stenosis. This is not comparable to the PILD group, which requires a defined symptomatic diagnosis of neurogenic claudication followed by a confirmation of hypertrophic ligamentum flavum through imaging. The experience of the treating physicians and the clinical studies on mild indicate there are clear diagnostic criteria for the PILD patient group.

Lack of consensus on the treatment of LSS

The NCA cites a lack of consensus on the treatment of LSS as a reason for the non-coverage recommendation on PILD and then goes on to state that “For patients with more severe symptoms surgery is an option. In addition to open techniques, there are minimally invasive techniques for laminectomy.” We are perplexed by this statement for several reasons. First, citing therapies like “minimally invasive techniques for laminectomy” as options seems contrary to the fact that the published record on these therapies does not meet the clinical evidence standards set forth in the NCA. Secondly, the statement ignores the treatment gap that exists between conservative treatments (including pharmacological intervention) and surgery. There are many patients that are not suitable surgery candidates and/or cannot tolerate anesthesia due to comorbidities and advanced age. The majority of these patients have no other treatment options besides PILD. Lastly, it seems contrary to best practices in patient care and optimal use of health care resources to advocate an escalation from conservative treatments to surgery without consideration of more minimally invasive options like PILD, especially when the efficacy evidence for these more invasive therapies does not exceed that of PILD and the risk factors are greater.

The required standard for pain procedures

The NCA asserts that there are numerous uncertainties to treating lumbar spinal stenosis and pain that consequently require a high evidence standard in order to properly evaluate efficacy. The main reasons cited are: lack of consensus on LSS diagnosis criteria and the susceptibility of the placebo effect for pain procedures. This has led CMS to conclude that “The general reliance on case series rather than robust randomized sham controlled clinical trials with explicit protocol driven criteria further limits the persuasiveness of the evidence.”

We disagree with the foundation for the standard of evidence, the requirement of “randomized sham controlled trials”, and the characterization of the mild data as “case series” and would like to address each in turn:

1. The foundation for the standard of evidence: lack of consensus on LSS diagnosis criteria, & the susceptibility of the placebo effect for pain procedures

Our comment has previously addressed the concern over the lack of consensus on LSS diagnosis criteria. The issue of the placebo effect has been discussed in the peer reviewed literature but a thorough systematic review of long term placebo effects on interventional pain studies has not been done to our knowledge. The JAMA article by Beecher is often cited to indicate that 35% of patients may experience therapeutic benefit as a result of the placebo effect (5). A limitation of this article is that it does not address the issue of long term placebo effect or demonstrate that these “therapeutic benefits” have achieved a clinically meaningful difference (CMD) threshold so the 35% number can be considered to be a high number. Given this information, it is hard to attribute the therapeutic benefits seen with the mild procedure to a placebo since, according to Levy, et al., “One hundred and thirty-four patients comprise the Year One population, 81% of which were considered responders. In these patients, baseline VAS was 7.4 and Year One VAS was 3.5, yielding a mean pain improvement of 3.9 (+/- 0.42, 95% CI). Likewise, their mobility at 1 year was significantly better than at baseline, improving from 46.6 to a Year One mean of 30.6, a 16.0-point improvement” (6). These high responder rates and statistically significant / clinically relevant results were achieved in studies that were specifically designed to reduce bias. Almost all of them had multiple, validated outcomes measures such as ZCQ, SF-12, VAS, ODI, PDI, & Roland-Morris Questionaire. All studies showed statistically-significant improvements and clinical relevance using multiple instruments. In addition, the studies were conducted over multiple study sites (14 centers in the MiDAS I study) so it seems difficult to conceive that outcomes measure bias could have been repeated across multiple sites using multiple validated outcomes measures. Finally, the results seen in the Brown RCT should be of particular interest to the issue of bias. In this blinded study, pain reduction at 6-week follow-up was statistically significantly better for patients treated with mild versus those treated with ESI. Further, 100% of the control group (ESI treatment) crossed over to the PILD procedure after study’s end and their pain reduction at 6 weeks was very similar to that experienced by the originally assigned mild–randomized cohort (7). This result is hard to explain on the basis of placebo effect.

In summary, attributing the benefits seen in the mild procedure data to placebo effect or some other bias seems to be difficult to explain given the high responder rates and clinically relevant / statistically significant results over multiple long term studies and multiple study sites, including a randomized control trial.

2. The requirement of “randomized sham controlled trials”

We agree that randomized control trials are desirable in many circumstances but we also want to point out that they are not appropriate in certain circumstances. When considering the options for conducting a Randomized Controlled Trial (RCT) with PILD, there are no study design options that could be conducted successfully. The three types of RCTs that could be considered are an Active Intervention Control study, a Sham study, and No Intervention Control study.

The possibilities for an Active Intervention Control RCT include conservative therapy or decompression surgery. Conservative therapies, including ESI, have been shown to provide only temporary pain relief for LSS patients suffering from painful neurogenic claudication. Offering patients a randomization design with temporary therapy in one arm and permanent therapy in the other is not practical, and patients would not agree to be randomized into this study design. Further, the large majority of patients seeking treatment from interventional pain physicians have already failed conservative therapy, including ESIs. This results in an immediate bias if patients actually agree to be randomized since they have already failed ESI therapy. Alternatively, identifying patients prior to ESI treatment is also impractical because patients are generally referred to interventional pain physicians after failing conservative therapy, including treatment with ESIs. And finally, ESIs are most often administered as a series of injections over six to eight weeks, which eliminates the possibility of blinding.

Alternatively, surgical decompression procedures including laminotomy, laminectomy and fusion are performed by completely different physician specialties—generally orthopedic surgeons and neurosurgeons. The impediments to randomizing patients into a study where different physicians perform each of the treatment arms are numerous and extremely difficult to overcome. By definition, the results would be confounded by the fact that different physicians would be performing each treatment. Further, there would be no possibility of blinding, and the difficulty of identifying an adequate number of sites offering collaborative physician groups in the two treating specialties would be next to impossible. Lastly, as part of the informed consent process and IRB approval, the patient would have to be notified of the two treatment options and their significantly different safety profile. It is difficult to envision a situation where a patient would agree to randomization in a study with therapies that have such different safety profiles if they are a candidate for both procedures. These obstacles are significant, and together with the certain difficulty of convincing patients to agree to this type of randomization, renders this option unfeasible.

A sham study design, conducted for the purpose of eliminating placebo effect and maintaining patient blinding, would require all patients to undergo preliminary access steps of the PILD procedure, including placement of the access port. Actual PILD treatment, whereby small amounts of lamina and ligament are removed through the portal, would only be performed on patients randomized to the PILD treatment arm. While the PILD port is very small, any intervention exposes the patient to risk of infection, and other minor complications. Ethically, it is difficult to justify placing the PILD port in the lumbar spine, and then not treating the patient. Further, patients would be very opposed to undergoing a minimally-invasive lumbar spine procedure, while potentially not receiving therapy that could relieve their pain symptoms and staying in a “no therapy” cohort for an extended period of time.

And finally, a No Intervention Control RCT design would require patients randomized to the control group to receive no treatment. Since these patients have already failed conservative therapy, it would be a step backwards for them to then receive no treatment at all. It is difficult to imagine that patients would agree to this type of randomization, except for the very short-term.

There are no viable options for an RCT design comparing PILD to a concurrent control group.

3. The characterization of the mild data as “case series” and “weak”

The NCA has classified the data available for the mild procedure as “case series”, which based on Appendix A “General Methodological Principles of Study Design” provided with the NCA, places it 7th out of 8th place on the ranking of research design, which is below retrospective case control series and surveillance studies. This appears to be inconsistent with the fact that the studies were prospective and used multiple validated outcomes measures to reduce bias. This also seems very inconsistent with Levels of Evidence guidelines for AMA’s CPT process (which is based on AHCPR 1992). The table below shows this scale:

Based on this categorization, the mild body of evidence would consist of one “1b”, six “IIb”, and three “IV” studies (see table below). While CMS may have its own method of evaluating clinical evidence, it is relevant to note that the CPT Category I code application requires that at least one publication must meet or exceed the criteria for Level lII. Clearly, PILD exceeds these criteria as there are currently seven studies and eight publications rated higher than Level III. That two different evaluation systems used to establish coverage can yield such different conclusions on the strength of the evidence is striking. Furthermore, it is difficult to categorize the appraisal conducted by CMS in the Proposed Decision Memo as a systematic review since no methodology was described and a well-accepted Level of Evidence grading scale was not applied. This creates issues with the interpretation of the evidence and characterizations that the evidence is “weak”. Specifically, characterizing multiple well-designed, prospective, multi-center, non-randomized studies with one to two-year follow-up as employing less rigor than “retrospective case control studies” and “surveillance studies (registries or surveys)” seems to be illogical. As such, we disagree with CMS’s characterization of the studies and the subsequent conclusion that the studies are “weak”.

Level of Evidence Type of Evidence:
As Defined and Utilized by American Medical Association, Current Procedural Terminology (CPT)
Ib
Randomized Controlled-Trial:
1. Double-blind, Randomized, Prospective Study of ESI vs. mild (One Center / 38 Patients)

IIb
Well-designed prospective, multi-center, quasi-experimental study:
1. MiDAS I (14 Centers / 78 Patients)
2. MiDAS II (8 Centers / 55 Patients)
3. MiDAS III (22 Centers / 122 Patients)

Well-designed prospective, single-center, quasi-experimental study:
4. Mid-Ohio Neurosurgical Care, Mansfield, OH / Chopko (One Center / 14 Patients)
5. The Center for Pain Relief, Charleston, WV / Deer (One Center / 46 Patients)
6. Cleveland Clinic, Cleveland, OH / Mekhail (One Center / 40 Patients)
IV Prospective, multi-center, pilot case series:
1. Procedure Description and Case Series / Wong (Five Centers / 17 Patients)

As a final point, we would like to comment on items that the NCA did not mention but should be part of an evaluation of this therapy. We discussed earlier in this comment how this therapy filled a treatment gap between conservative treatments and surgery. This view has been echoed in numerous comments to the NCA but not acknowledged by CMS in its analysis. Additionally, we would like to bring to CMS’s attention the reduction in health care resources that this therapy offers. In our comment in April we indicated that a “recently-published article by Wang et al. in April 2013 in the peer-reviewed journal, Pain Medicine, titled “Decrease in Health Care Resource Utilization with MILD” reported a 45% reduction in time spent in specialty care and an almost fourfold decrease in number of interventional pain procedures performed on patients with lumbar spinal stenosis. Further, over half of the patients who had undergone the mild procedure no longer required chronic pain management to treat LSS symptoms. These authors conclude that mild is not only a reliable method to treat LSS, it also appears to reduce the consumption of limited health care resources (8).” It appears that this was not considered in the NCA but it is an important potential benefit based on the numerous comments and experiences of our physicians.

In conclusion, we would like to reiterate our stated support of this procedure. We do not believe that NCA presents an accurate depiction of the clear diagnostic criteria in use for evaluating PILD patients, sets an appropriate standard of evidence for interventional pain procedures, accurately reflects the evidence on the mild procedure, addresses the treatment gap that exists in LSS treatments (and is filled by mild), or considers the lower use of health care resources this procedure provides. We, therefore, urge CMS to reconsider its position.

References

Frank Falco, MD
Immediate Past President
American Society of Interventional Pain Physicians

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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, safe, and long lasting.

I identify lumbar spinal stenosis and most importantly neurogenic claudication patients easily by history, physical exam and MRI evidence. I routinely offer conservative care first including NSAIDS, pain medication, physical therapy and epidural steroid injections. Many people improve with the aforementioned treatment options. However if they do not, they are offered a surgical referral or a discussion on PILD. If the patient has sever symptoms or many other anatomical problems I will not offer PILD.

I see many patients that have failed spine surgery. Many times the patients that I see are suffering worse than they were prior to corrective surgery. These patients end up receiving very expensive care including narcotic medications and implantable devices such as spinal cord stimulators and intrathecal pain pumps. Appropriate patients should be given access to the PILD before embarking on open laminectomies and instrumentation.

The patients that I have performed this procedure over the last 2 years follow up with me at 2 weeks, 12 weeks and 12 months. More than 75% are reporting significant improvements in ability to walk further, stand up straighter and have less pain. My personal experience is that the procedure works and has durability.

I have not had any adverse outcomes or problems related to this procedure. There are also studies in pain literature that show rare if any untoward effects. The beauty of the procedure is that there is built in safety and margins that you can see with the epidurogram. As long as you don't push into the contrast area you are in a safe zone.

The comment on placebo effect and interventional pain procedures as a whole does not belong in this discussion and is deeply offensive. It clearly shows the BIAS of the author against my profession as a whole. Obviously there is an underlying agenda to discredit all that we do to help patients with chronic pain and suffering. I demand an unbiased and fair evaluation of this new treatment that improves quality of life, is minimally invasive, and does not preclude the patient from going on to spine surgery if needed. My practice works with spine surgeons that recommend the PILD first if the patients is too sick with comorbid issues to sustain under anesthesia for 4-6 hours.

There is a plausible mechanism of action and more than 15 studies that show positive outcomes. Many of these were done in hospitals that have excellent reputations i.e. Cleveland Clinic. Placebo effects have been found to account for 7-35% positive effects based on Cochrane review articles. That doesn't explain the overall 75% success rate of PILD. I have walking proof of its success every day. One of my nurses had it done with me and she is eternally grateful for the relief she enjoys.

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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 done. In other words, they no longer need repeated lumbar epidurals to control their neurogenic claudication symptoms.

The process involved in doing the MILD procedure involves techniques that make it very safe to do. The application of contrast in the epidural space makes visualization of the location of the dura easy and prevents the provider from doing any harm to neural structures with the instruments used in MILD.

I think one of the major advantages to the MILD is that it can be a very cost effective alternative for patients who are not good candidates (because of other health conditions) for general anesthesia. MILD requires only moderate IV sedation and eliminates the need for general anesthesia. I have been approached by our local neurosurgeon who has referred patients to me who have severe back pain associated with their lumbar spinal stenosis and are not good candidates for general anesthesia. These patients would otherwise have no other alternative and would require a combination of multiple epidurals and chronic medication management.

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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, emotional, and financial hardships placed on patients secondary to LSS which can be a debilitating painful disease. I am writing to extend my thoughts on the unfavorable coverage decision memo CMS has posted on its website.

CMS states that there exists an absence of diagnostic consensus constrains any significant consensus on treatment, according to CMS, there is no consensus in the treatment of lumbar spinal stenosis (LSS) due to the clinical heterogeneity of the disease state, I would dispute this general statement and offer the following; For patients with spinal stenosis there lies a subgroup of patients with neurogenic claudication (leg pain with walking and standing upright) secondary to LSS and ligamentum flavum hypertrophy in which there is a defined treatment option. Please note a recent article by Deyo et al , a study of 12,154 patients were selected based on the primary diagnosis of lumbar stenosis and further categorized by using the CPT codes (Current Procedural Terminology) indicating lumbar discectomy, laminectomy, or fusion. This suggests that there is a modicum of consensus in the treatment of lumbar spinal stenosis (LSS) that’s recognized by CMS. Complication rates reported in this study included a rate for wound complications (3.2%) and life-threatening complications (2.4%).
Standard posterior decompressive laminectomy of patients with LSS in the SPORT trial was based on the diagnosis of neurogenic claudication or radicular claudication and spinal stenosis demonstrated on cross-sectional imaging. Overall complication rates ranged from 9.9% for intraoperative complications to 12.3% for postoperative complications.

In bilateral microsurgical decompression of the lumbar spine using a unilateral approach, patient selection is based on claudication attributable to degenerative LSS and confirmatory imaging of one or more levels of spinal stenosis.

According to a published report by Deyo et al, primary diagnosis of lumbar spinal stenosis was found in 98.2% of patients selected. Trends in surgery associated with LSS noted a reduction in decompression surgery and simple fusion cases in the study period but an increase of a factor of 15 in complex fusion surgery. Life-threatening complications increased with more complex surgical procedures, 5.6% in patients with complex fusions compared to 2.3% in patients with decompression alone.

In 2012, Levy and Deer reported on 373 patients in a safety review and meta-analysis and found that there were zero (0) reports of device or procedure-related adverse events. They also reported one-year efficacy data that demonstrated statistically significant improvement in the patient’s pain and mobility. To date there have been 7 reported complications in 15,000 procedures for an overall complication rate of 0.05% as reported in the MAUDE database.

It is critical to understand that the PILD procedure offers a great service to the Medicare beneficiaries as well as their treating providers in offering an unmet need.

This procedure is absolutely mandatory for a certain patient population. Without access to PILD, these patients may undergo much more aggressive treatments such as laminectomy or fusion that have huge biophysical effects on the stability of the spine and are much more invasive. There also exists a subpopulation of severe central canal stenosis patients with significant medical co-morbidities that cannot undergo more invasive surgical options due to risk of complications. These patients are going to suffer with pain, immobility, and likely will be required to become opiate dependent for pain control without access to PILD. I urge CMS to reconsider its unfavorable decision.

I can personally attest to the success of the procedure in every patient that I have performed it for. With proper patient selection the procedure can be unbelievable effective with little effect on stability. Given the minimally invasive nature of the procedure, the safety, and efficacy that I have personally seen, I can unequivocally state I would recommend this procedure (given the appropriate pathology) to my patients, my family, or myself if I required it.

Thank you for your consideration.

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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 patients in to seeing a spine surgeon, which more times than not, that is not the case. At that point we are left palliating their pain with powerful opiod pain medications, which in the elderly lead to multiple side effects including severe mental status changes which often leads to a costly admission to the hospital.

Along comes the MILD procedure, and now I have much less invasive, safe and effective outpatient procedure which I can offer as an alternative to classical open surgical decompression surgery. Our practice results shadows that of the published literature, in that we have had great success without any costly untoward side effects for the patients we have treated with the MILD procedure. Certainly, it is not 100%, but neither is surgical decompression.

There were many reasons given to why the committee didn't feel that this procedure warranted CMS approval. First, there was discrepancy in how spinal canal stenosis is defined. In our community, spinal canal stenosis is defined clinically as patients, typically elderly, who have back or leg pain which is brought on with standing and or walking. Their quality of life is markedly altered by their complaints. They markedly alter their life style based on their intolerance of standing or walking. Radiographically, a CT scan or MRI will demonstrate narrowing of the central spinal canal secondary to disc bulging, facet hypertrophy and ligamentum flavum thickening. In our practice, these patients are very easily identifiable.

Next, there was criticism of the published studies because many of them had industry involvement. In this day and age of tight health care dollars, if industry WASN"T involved it would be very difficult to find the financial support needed to perform these studies. I agree that their involvement certainly opens the door for bias, however but again without their help many of these studies wouldn't have happened.

Finally, there was comment that there were no double blinded- placebo controlled studies available for review. Again, it is very difficult, if not unethical, to perform sham procedures on PEOPLE, who are in pain who need and deserve real help. Would you enroll your parents or grandparents in a double blinded placebo controlled study using regarding an invasive procedure when there was a 50% chance that could end up having a SHAM procedure. Most people would say no.

Finally, if every invasive or surgical procedure was put through this type of criteria, most new procedures would not be approved and many EXISTING procedures would no longer be paid for. How many patients would sign up for a study where they potentially could have a sham surgical procedure which wasn't helpful?

In closing, so instead of shutting the door on this breakthrough procedure that has benefitted thousands of patients across the nation, including many of those in our practice, I would suggest that CMS do the following.

1. Set up selection criteria for the procedure as described in the literature. This should include failure of more conservative measures, and radiographic evidence of ligamentum flavum thickening greater than 6mm at the level of stenosis in patients with neurogenic claudication.
2. Monitor the results of the patients who have been treated over a 2 year period .
3. Consider comparing the results to patients who have undergone surgical decompression.

I think this is a mistake. Perhaps if the physicians involved with this decision were involved with managing these patients daily, they would see why this is not the right thing to do.

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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 Criteria, and 5) Input from specialty societies. Based on these points and others raised by pain management specialists, treating physician specialty societies, and thought leaders in the comments submitted, we request that CMS approve coverage for PILD.

Diagnosis and Treatment of LSS
To support its proposed non-coverage decision, CMS asserts that there is no overall consensus regarding the diagnosis of LSS, and therefore states that since “there is no consensus diagnostic definition for LSS, there is a corresponding lack of consensus on treatment.” We respectfully disagree with this statement, as there are very clear diagnostic criteria for identifying patients appropriate for the PILD procedure, that are described below. In addition, we are concerned that the implications of CMS’s position regarding the lack of consensus on diagnosis and treatment of LSS have significance beyond the PILD procedure.

The diagnostic criteria for LSS are well-established (Katz 2008). Moreover, many of the commenters, including faculty members at two medical schools as well as the treating physician society (American Society of Interventional Pain Physicians (ASIPP)), had little difficulty explaining these criteria. In any event, the position taken in the proposed decision memo overlooks the fact that the investigators in the PILD studies used reasonable diagnostic criteria to assure themselves that their subjects had LSS with neurogenic claudication. CMS also commented that “hypertrophy of the ligamentum flavum” is among the accepted qualitative criteria for the diagnosis of LSS; this is an inclusion criterion spelled out in the MILD studies. Further, the majority of the MILD studies, including the double-blind randomized controlled trial (RCT), used explicit exclusion criteria to ensure that patients who had predominant other causes of LSS were excluded.

Moreover, CMS’s concern on this point overlooks the fact that the Medicare program currently covers many types of procedures for the treatment of LSS, ranging from non-operative treatment such as physical therapy, adhesiolysis, analgesics and ESIs, to invasive decompression surgeries, all of which can be based on the diagnosis criteria discussed in the comments.

The general progression of decompression surgery as a treatment both in terms of cost and complexity is laminotomy, laminectomy, and decompression with fusion. On this point, the American Academy of Pain Medicine properly notes that notwithstanding CMS’s concerns, open decompression procedures are used widely for refractory LSS, even though the risks to Medicare beneficiaries are greater than with a minimally invasive procedure such as PILD. As a result, CMS’s concerns over LSS treatment criteria are already addressed and should not become an obstacle for this one treatment option for LSS.

Level of Evidence on PILD
CMS asserts that the body of published evidence on PILD does not support a conclusion of improved health outcomes for Medicare beneficiaries. CMS has characterized the published studies on PILD as a “case series”. Further, CMS has criticized the PILD double-blind, randomized, prospective study comparing PILD to ESI for a variety of reasons including inadequacy of comparator and low enrollment. All studies were criticized by CMS for not clearly defining LSS diagnosis, not describing conservative care, not defining co-interventions, and not adequately controlling for placebo bias and confounding.

Vertos respectfully disagrees with the characterization of the clinical evidence. The MILD evidence contains multi-center, prospective clinical studies that used multiple, validated scales to assess patient outcomes—some with as long as one to two year follow-up. These studies, the level of evidence, and the concerns raised in the draft are fully addressed through the comments by publication authors (Benyamin, Brown, Chopko, Deer, Grider, Lingreen, Wong), over 150 treating physicians, key institutions like the Mayo Clinic and Cleveland Clinic, and treating physician societies like AAPM and ASIPP. With respect to the supposed placebo effect, the PILD literature and the comments rebut the suggestion that any improvement in functionality is caused by a placebo. As stated by ASIPP in their comment “All studies showed statistically-significant improvements and clinical relevance using multiple instruments. In addition, the studies were conducted over multiple study sites (14 centers in the MiDAS I study) so it seems difficult to conceive that outcomes measure bias could have been repeated across multiple sites using multiple validated outcomes measures. Finally, the results seen in the Brown RCT should be of particular interest to the issue of bias. In this blinded study, pain reduction at 6-week follow-up was statistically-significantly better for patients treated with MILD versus those treated with ESI. Further, 100% of the control group (ESI treatment) crossed over to the PILD procedure after study’s end and their pain reduction at 6 weeks was very similar to that experienced by the originally assigned MILD–randomized cohort. This result is hard to explain on the basis of placebo effect.” A thorough comment was also submitted by Dr. Zubieta from the University of Michigan who is a researcher in the area of placebo effect. He stated: “I have performed an extensive review of the pertinent literature using PubMed and examining all published data on surgical approaches to back pain...This literature review indicates the absence of exact estimates of the effects of placebo, natural history and regression to the mean in persistent back pain. However, based on the information available from the limited number of randomized trials in this disorder, these effects appear low, even when a potentially active condition (e.g., epidural steroid injection, Brown 2012; standard physical therapy, Fritzell et al., 2001) is compared against an intervention. On the contrary, the data available for PILD suggests significant improvements in both pain report and disability ratings which exceed the expected cumulative rate of placebo response, regression to the mean and changes due to natural history expected in persistent low back pain.” The conclusion of these submissions (and others) is that a placebo effect cannot account for the consistency of the data across multiple studies, multiple sites, and long periods of time.

Moreover, the strength of the evidence on PILD scores in the top two tiers of the widely-accepted Level of Evidence hierarchy used by AMA in the CPT coding process (Ib and IIb), and should not be ignored; if anything, the standard of evidence discussed in the proposed decision memo raises the question of a consistent application of the level of evidence requirements for all covered therapies treating the same patient population—in this case symptomatic LSS patients. A closer look at the medical literature fully supports coverage for PILD.

Given that surgical decompression and ESIs are both covered by Medicare for the treatment of LSS, we conducted literature searches for the purpose of characterizing the level of evidence for these procedures to help determine if they would meet the criteria discussed in the proposed decision memo. First, on November 12, 2013 a decompression surgery literature review was conducted by searching the PubMed database for the following key phrases: "Lumbar decompression for symptomatic lumbar spinal stenosis,” “Lumbar laminotomy for symptomatic lumbar spinal stenosis,” “Lumbar laminectomy for symptomatic lumbar spinal stenosis,” “Microendoscopic decompression laminotomy,” “Surgical treatment for lumbar spinal stenosis,” and “Neurogenic claudication and lumbar decompression.” The search results were limited to reports published in English during the last ten years, and included studies conducted in all countries. All reports were specific to the human population, and were screened to include only those with more than ten patients per treatment arm. A total of 41 studies met these parameters and were retrieved for review. Of these, six were RCTs, one was a prospective two-center case series, 15 were prospective single-center case series, 18 were retrospective observational studies and one was a systematic review with meta-analysis. Throughout all 41 reports of surgical decompression, descriptions of LSS diagnosis prior to surgical intervention, failed conservative care treatments, LSS co-factors, patient co-morbidities upon presentation and co-interventions including analgesic usage are inconsistent, variable and frequently excluded altogether. This body of evidence, therefore, would not meet the standard the NCA proposed on reporting these elements. Of the six RCTs, only two studies had a nonsurgical comparator (SPORT and Malmivaara, et al.). Neither of these remaining studies was blinded. The Malmivaara study only reported MCID on one outcome measure (ODI) and as mentioned before, this study did not report on analgesic use, cofactors, etc. The landmark SPORT study began as an RCT comparing surgical decompression with “usual nonsurgical care,” and subsequently added observational arms for both treatment groups due to difficulty finding patients willing to be randomized into this study. The SPORT study is also notable for illustrating the difficulty of protocol adherence for long term studies in LSS. At one year, only 63% of the randomized patients assigned to the surgery cohort had undergone surgery and 42% of the randomized patients assigned to the no-surgery cohort had crossed over to get surgery. Based on CMS’s requirement in the NCA, these two well-designed studies would have not met the criteria for adequate RCTs.

On November 13, 2013 an ESI literature review was conducted by searching the PubMed database for the terms "Lumbar Spinal Stenosis" and "Epidural Steroid Injection.” Literature search results were limited to reports published in English during the last ten years, and included studies conducted in all countries. All reports are specific to the human population, and were screened to include only those with more than ten patients per treatment arm. Post lumbar surgery study populations were excluded. A total of 40 studies met these parameters and were retrieved for review. Of these, eight were RCTs, one was a prospective multi-center case series, eight were prospective single-center case series, twelve were retrospective observational studies and eleven were systematic reviews. Throughout all 40 ESI reports, there is no consistent reporting of LSS diagnostic criteria, definition of conservative therapy, or reporting of co-interventions as required by CMS in this NCA. This body of evidence, therefore, would not meet the standard the NCA proposed on reporting these elements. Discussions of placebo bias and confounding are also rare. All eight ESI RCTs were conducted with active comparators. Two of eight RCTs were not double blinded. Six of eight RCTs demonstrated no statistical significance between the two treatment groups. One RCT that did show statistical significance (Brown 2012) showed better results for the non-ESI treatment arm. Despite this, it is well-established by treating physicians that ESIs provide significant benefit for the right patient. However, the published literature on ESI would not meet the requirements for coverage set forth by CMS in the NCA.

Given this discussion on ESI and surgery, one is left to wonder about important related considerations: 1) How realistic and legitimate is the evidence standard set by CMS if two very well established and beneficial therapies like ESI and surgery do not meet the criteria? 2) How do almost twenty PILD reports of statistically-significant improvement in multiple validated outcome scales for hundreds of LSS patients at follow-up as long as one and two years not meet a coverage standard when other therapies with comparable levels of evidence do?

Finally, the safety profile for PILD as reported in the peer-reviewed literature is excellent when compared to other interventions, which is further supported by the comments submitted by multiple experienced practitioners and pain management professional societies. On this point, Vertos questions CMS’s reliance on the statements in 2012 by Tumialan. This report was a letter and so is missing much vital information that the real circumstances under which these adverse events occurred are not described. Moreover, this letter was not peer reviewed. These are important considerations because they contrast so sharply with the published clinical data of more than 500 patients and the wide range of physicians who have posted comments to this NCA.

PILD Mechanism of Action
Regarding the mechanism of action, PILD is performed by percutaneously removing fragments of laminar bone and ligamentous tissue. Adequate decompression is visually confirmed intra-procedurally through specific changes in the epidurogram using multiple images and various fluoroscopic views. CMS asserts that “[w]e cannot be certain that removing a few tiny segments of connective tissue with the PILD tool makes any real structural difference despite the fluoroscopy image of the patient bent forward during the procedure.” Further, CMS goes on to say that “[a]s with any invasive procedure where tissue is altered, changes from the preoperative radiographic evaluation should correlate with outcomes after decompression.” Importantly, the association between extent of spinal canal narrowing and clinical symptoms has not been established, and has been reported to have poor correlation. Mattei (Mattei 2013) in his well-researched Letter to the Editor, which is used as a reference by CMS, concludes that “the correlation between lumbar canal dimensions and clinical symptoms in patients with neurogenic claudication is very poor.” Further, Haig et al. (Haig 2009) report that they were “unable to find a useful association between MRI findings and symptoms.” Amundsen and colleagues (Amundsen 1995) examined 100 consecutive LSS patients clinically and radiologically. These authors concluded that “the degree of narrowing did not correspond to the degree of clinical affliction.” This view is supported by numerous other publications including Siebert et al. (Siebert 2009) and Suri et al. (Suri 2010). Kreiner, et al. also commented in an evidence based guideline that “[t]here is insufficient evidence to make a recommendation for or against a correlation between clinical symptoms or function with the presence of anatomic narrowing of the spinal canal on MRI” (Kreiner 2013).

These observations are addressed in the comment filed by Dr. Wong, the chief of interventional spinal radiology at the University of California – San Diego School of Medicine who framed the appropriate question to be answered by every pain management physician: given the lack of “established evidence that a difference in pre to post-op MRI is correlated to positive outcomes,” “why would one consider change in fluoroscopic imaging as less relevant than an MRI? After all, fluoroscopy has many relevant advantages. First, the patient’s position does not change during the procedure, so it is fair to state that the change in the fluoroscopic image pre and post procedure is as a result of the procedure itself. Secondly, fluoroscopy allows for dynamic view of the area currently under treatment. This is particularly useful since the goal of the procedure is to reduce pressure sources on the central canal. An improvement in flow of contrast dye happens when restriction to that flow have been removed. All of this leads to an existential question on the treatment of LSS. If CMS requires correlation between outcomes and radiographic imaging for the approval despite the fact that the published literature does not support this correlation and CMS uses this as a basis for denial of PILD then what does CMS propose for ALL LSS treatments? After all, existing treatments may be able to show changes in an MRI but that doesn’t necessarily translate to a successful outcome.”

PILD Patient Selection and Diagnostic Criteria
In general, candidates for PILD treatment have failed conservative treatments for a specified time period. This is entirely consistent with the clinical guideline cited in the proposed decision memo. The PILD procedure treats LSS patients suffering from neurogenic claudication with hypertrophic ligamentum flavum as a main contributing factor. Neurogenic claudication has a widely accepted diagnostic protocol, and is defined as patient presentation with low back pain, buttock and/or leg pain associated with prolonged standing and walking that eases with flexion, sitting or lying down. Sandella, et al. (Sandella 2013) (cited by CMS in the proposed decision memo) concluded that “[w]ithin 5 questions, clinicians become almost 90% certain that a person has clinical spinal stenosis.” Kreiner, et al. also indicated that diagnosis for LSS was backed by evidence and stated that “[i]n patients with history and physical examination findings consistent with degenerative lumbar spinal stenosis, magnetic resonance imaging (MRI) is suggested as the most appropriate noninvasive test to confirm the presence of anatomic narrowing of the spinal canal or the presence of nerve root impingement. Grade of Recommendation: B”. The PILD diagnostic criteria are clearly defined as diagnosis of neurogenic claudication followed by radiographic confirmation of ligamentum flavum hypertrophy as a main contributor to stenosis. We recommend that CMS incorporate these criteria into a final determination.

Input from Specialty Societies
Finally, although the draft decision memo includes references to statements by surgical specialty societies, we must note that these references came from organizations that have little or no experience with the PILD procedure, and whose members are not the treating physician group for this therapy. A CMS longitudinal database review of treating physicians billing for procedures using the current CPT code for PILD, 0275T, for the year 2012 determined that less than 1% of procedures were done by surgeons. In clinical practice, our experience has been that the PILD technique is better suited to the training and practice of individuals that use real-time fluoroscopy (epidurogram) on a regular basis as part of a treatment, which is not prevalent in the surgical community. This explains why approximately 96% of treating physicians were classified as interventional pain management, anesthesiology, pain management, and physical medicine and rehabilitation specialists. Almost all of the research studies and publications were done by non-surgeons. These facts make it especially perplexing that the societies that represent interventional pain specialties (ASIPP, AAPM, etc.) appear not to have been consulted during the NCA process. We urge CMS not to rely on the opinions of organizations with no significant demonstrated use of the therapy.

All of the published and peer-reviewed evidence demonstrates that PILD is an efficacious, safe, outpatient procedure that uses very few health care resources. Vertos has also been very clear in stating that PILD is not a remedy for all forms of LSS. However, if a patient is a PILD candidate, it is consistent with accepted medical practice to have PILD as a treatment option. The problem was summarized in a comment filed by nine physicians at the Mayo Clinic, including the chair of its pain medicine practice: “If you or a loved one suffered from severe spinal stenosis that greatly affected your ability to ambulate and was unresponsive to conservative treatments what treatment would you pursue? Would you go directly to an open surgery with general anesthesia, a hospitalization and its known complication rate or would you seriously consider the MILD procedure as an outpatient with minimal sedation? Based on a review of the cited studies and the experience of the Mayo Clinic we would certainly pursue the MILD procedure.”

On behalf of Vertos Medical, I would like to reiterate our strong commitment to scientific evidence, as well as proper patient selection and diagnostic criteria. The preliminary CMS assessment of insufficient evidence to support coverage of the PILD procedure is more than offset by the excellent efficacy and safety results that have been peer-reviewed and reported, as well as the overwhelmingly supportive comments by pain medicine specialists, thought leaders in pain medicine, and pain specialty societies received during both NCA comment periods. It cannot be disputed that this procedure has the potential to safely provide pain relief to certain LSS patients facing more invasive surgery or NO alternative treatment options. A non-coverage decision would certainly eliminate all viable alternatives for addressing the concerns expressed by CMS and would remove a promising treatment for patients that have few other choices. As can be seen from the comments, there is a great need for a therapy like PILD. We ask that CMS reconsider its proposed decision and approve Medicare coverage for PILD.

Bibliography:

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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 I have performed that if I removed that large ligamentum flavum from patients, they get better blood flow from less compression on the nerves when they stand up, and therefore are able to walk. Without this procedure, they would have needed to get help with daily activities. They were frustrated and now they are better. I followed the criteria that makes sense for this procedure and picked patients I thought would benefit AND THEY DID!. Now you want to take away the ability for me to use this as a procedure to improve they're pain and have them not be able to ambulate? There is no lack of consensus on what causes spinal stenosis, what there is is lack of treatments that work. I have a patient that is in a medicare HMO that was not given authorization to have the PILD procedure. The surgeon offered him a multilevel decompression and fusion (which would cost tens of thousands of dollars) and then his medical doctor said he can not have hours of general anesthesia, so the surgeon cancelled. He has an AICD and cardiac issues. He would benefit from the PILD and tolerate it well. It is medically necessary, but it will not happen if you do not reverse this decision. The PILD procedure takes a half hour under minimal if no sedation, and my patients had less if no pain afterward. I had NO adverse events. How can you have a placebo effect of being able to walk. They either can or can't walk without pain. I know that the mechanism of action is that pressure on the nerves and that this procedure is efficacious from seeing the dye spread where it once could not due to the enlarged ligament. I think you are doing a disservice to the medicare/elderly population by not allowing them to have a minimally invasive, low risk procedure to allow them to walk. As long as the strict criteria are met and I have already as a clinician proved to myself that it works, why prevent a patient from having this treatment. Makes no sense.

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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 surgical intervention and debility post-op compared to a minnimaly invasve technique.

These are but a few of the attributes of this procedure and I am hopeful we will be able to continue to provide this therapy to our patients.

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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 significant procedural morbidity, including dural tears, epidural hematoma, nerve root injury, and substantial operative blood loss requiring transfusion. Considering there are patients that fail multiple conservative measures, I am unclear as to why CMS would not consider the mild procedure as a minimally invasive option to open decompression. At what point does CMS consider the set population of elderly patients that are ruled out as surgical candidates due to co-morbidities? What treatment options are available to them? Mild provides significantly less cost, shorter hospital stays, and no adverse effects post operatively. These facts should compel you to consider this option for coverage. I have read the clinical data surrounding this procedure along with being trained to perform this minimally invasive procedure. I find this technology a critical step in the care of patients in an attempt to relieve their symptomatic pain as well as restore them to a reasonable level or functionally. I am strongly encouraged by the mild procedure outcomes and the opportunity to offer a minimally invasive option to my patients who would otherwise live in pain. I consider it not only unethical but a failure of my fiduciary responsibility to my patients to exclude a minimally invasive treatment option.

CMS states that there is a lack of consensus on diagnostic criteria for LSS. Although there are many conditions that lead to back pain I would pose the question that if Medicare does not believe there is a consensus in the treatment of lumbar stenosis how would you explain the current covered treatment established for its Medicare beneficiaries? To address CMS statement that there is no consensus in the treatment of lumbar stenosis due to clinical heterogeneity of the disease state I present a common sense conclusion. The PILD procedure is the best clinical option for a subgroup of patients with neurogenic claudication secondary to spinal stenosis and ligamentum flavum hypertrophy. I believe providing general patient “standards” of diagnosis and treatment for any condition falls short of providing quality individualized patient care. The human body is a complex machine full of mystery. Each patient’s genetic makeup is so varied it becomes impossible to treat with bulk standardized care. The PILD procedure is a minimally invasive approach to reduce pain and improve mobility in lumbar spinal stenosis (LSS) patients. Thousands of patients have been treated by mild, which is enabled by an innovative technology. The MILD® procedure (minimally invasive lumbar decompression), allows for paring down the thickened ligament, taking pressure off the nerves and relieving pain. I am disappointed that CMS did not consider these outcomes when making its decision. I would urge CMS to further consider this treatment option for it Medicare beneficiaries and appreciate the opportunity to provide feedback.

Sincerely,

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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, including increased standing time and walking distance. While the results vary from patient to patient, the common theme is that they have improved quality of life. Some wanted to walk one mile a day while others wanted to simply be able to wash their dishes and clean their kitchen after dinner without having to sit down every few minutes due to severe leg cramping. None are worse off than before the procedure. If any patient is unsatisfied with the outcome, which I have not heard at this point, that person can consider surgery and be referred accordingly. I understand that my findings are anecdotal and not related to any formal study.

There are a few things CMS should consider when making their decision about PILD, in particular the MILD Procedure. Since there are no specific diagnostic criteria nor any gold-standard diagnostic tool for LSS, and patients with severe lumbar spinal stenosis may have no symptoms or only mild symptoms of neurogenic claudication, why does CMS feel that open surgical decompression can be considered in these patients but MILD cannot? Do spine surgeons know more than spine interventionalists? Are they keeping their diagnostic criteria secret from the rest of the world? Or do they just have lobbyists with deeper pockets? Or do the companies that benefit from the surgeons, often time, unnecessary surgeries, have better connections at CMS? Why does CMS assume that surgery for LSS is an acceptable treatment simply because it has been around for so long despite studies showing poor outcomes? Many studies show no improvement after surgery. Lumbar postlaminectomy syndrome is so common, practically expected, that it is no longer a complication but an illness with its own ICD-9 code. I wonder who convinced the AMA that that was a good idea? Why is CMS not looking, nor hav they looked, at surgery for LSS for non-coverage? CMS is considering MILD, which may cost CMS a few thousand dollars for non-coverage, but has not looked at surgery, which costs considerably more, not considering all of the even higher "downstream" costs after surgery, for non-converage. This doesn't even stand up to the sniff test. If a patient has MILD, which we already know is a significanly cheaper and safer procedure than open surgery, and does not get acceptable relief, they can always consider surgery. If they have surgery first and do not do well, they cannot consider MILD. Period. The damage has already been done.

Another thing to consider is why the spinal instrumentation companies have been so vocal in trying to convince CMS to not cover MILD. Do they consider MILD a threat to their business? They would only consider it a threat if it was an effective treatment for LSS.

For symptomatic LSS patients who do not want surgery or who are not candidates for surgery, MILD is a safe, effective and inexpensive option. It falls in the continuum of treatment for LSS between conservative management (physical therapy and epidural steroid injections) and open surgical decompression. To take this treatment option away from patients would border on unethical.

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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 unreasonably restrictive of the ability of a pain management physician to provide meaningful improvement in the life of a Medicare patient.

To this end, we believe that CMS should consider the large and growing elderly population who are either unwilling or unable to tolerate general anesthesia and the potential adverse effects associated with open decompression procedures. It is necessary to introduce less-invasive therapy options that treat the underlying cause of the condition to provide long term relief. Conservative medical management is not a long term treatment option for this subset of lumbar spinal stenosis patients that have neurogenic claudication. To suggest that medical management is a treatment option for these patients will only contribute to the prescription drug abuse problem in America.

The MILD procedure offers this subset of patients, those with lumbar spinal stenosis with neurogenic claudication, a viable treatment option that can improve their quality of life. Patients with neurogenic claudication are easy to diagnose- their ability to walk or even stand upright is severely limited by the pain and discomfort in the lower back, legs or buttocks during activity. This pain and discomfort is relieved with flexion, when they bend forward or sit down. An MRI can confirm the clinical symptoms to show the level and severity of the stenosis. This same diagnostic process, including clinical symptoms and MRI confirmation, is how surgeons are diagnosing LSS and performing laminotomies, laminectomies and fusion. This begs the question: why would the MILD procedure need to have a more strict diagnosis requirement than the already covered and broadly used CMS surgical procedures that treat the same condition? To quote the SPORT study, “all patients had neurogenic claudication and/or radicular leg symptoms; confirmatory cross-sectional imaging showing lumbar spinal stenosis at one or more levels; and were judged to be surgical candidates.” (New Engl J Med, 2008)

Rarely do elderly patients present with hypertrophic ligamentum flavum only. This is a degenerative condition, so the stenosis can also be caused by disc bulge, osteophyte formation, etc. which also impinge upon the canal. If the hypertrophic ligamentum flavum is a predominant factor of the stenosis then MILD can help these patients. In the article on Cleveland Clinic study, it stated “review of these patient MRIs usually reveals that the cause of symptomatic LSS is multifactorial in nature. Disk bulge, facet hypertrophy, and invariably, ligamentum flavum (LF) hypertrophy, which compromises the central canal, are commonly found. Clearly, it is not necessary to correct every casual factor in a large population of LSS patients. It has been reported that the majority of LSS patients have hypertrophy of the LF and that its thickness may account for 85% of lumbar spinal canal narrowing.” (Pain Practice, 2012)

We believe that the MILD procedure has proven that we can treat one causal factor of LSS with a minimally invasive approach that is safe and effective. By treating the underlying cause of the condition we can provide improved quality of life for a large and growing elderly population that do not consider open decompression procedures as viable treatment option. For these patients who feel they have no options, we strongly suggest a positive National Coverage Determination for PILD, or MILD.

I am a PA that works in a pain management office, and I believe that PILD or MILD is very beneficial to the patient's that have been treated by my supervising physician.

Respectfully,

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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 unreasonably restrictive of the ability of a pain management physician to provide meaningful improvement in the life of a Medicare patient.

To this end, we believe that CMS should consider the large and growing elderly population who are either unwilling or unable to tolerate general anesthesia and the potential adverse effects associated with open decompression procedures. It is necessary to introduce less-invasive therapy options that treat the underlying cause of the condition to provide long term relief. Conservative medical management is not a long term treatment option for this subset of lumbar spinal stenosis patients that have neurogenic claudication. To suggest that medical management is a treatment option for these patients will only contribute to the prescription drug abuse problem in America.

The MILD procedure offers this subset of patients, those with lumbar spinal stenosis with neurogenic claudication, a viable treatment option that can improve their quality of life. Patients with neurogenic claudication are easy to diagnose- their ability to walk or even stand upright is severely limited by the pain and discomfort in the lower back, legs or buttocks during activity. This pain and discomfort is relieved with flexion, when they bend forward or sit down. An MRI can confirm the clinical symptoms to show the level and severity of the stenosis. This same diagnostic process, including clinical symptoms and MRI confirmation, is how surgeons are diagnosing LSS and performing laminotomies, laminectomies and fusion. This begs the question: why would the MILD procedure need to have a more strict diagnosis requirement than the already covered and broadly used CMS surgical procedures that treat the same condition? To quote the SPORT study, “all patients had neurogenic claudication and/or radicular leg symptoms; confirmatory cross-sectional imaging showing lumbar spinal stenosis at one or more levels; and were judged to be surgical candidates.” (New Engl J Med, 2008)

Rarely do elderly patients present with hypertrophic ligamentum flavum only. This is a degenerative condition, so the stenosis can also be caused by disc bulge, osteophyte formation, etc. which also impinge upon the canal. If the hypertrophic ligamentum flavum is a predominant factor of the stenosis then MILD can help these patients. In the article on Cleveland Clinic study, it stated “review of these patient MRIs usually reveals that the cause of symptomatic LSS is multifactorial in nature. Disk bulge, facet hypertrophy, and invariably, ligamentum flavum (LF) hypertrophy, which compromises the central canal, are commonly found. Clearly, it is not necessary to correct every casual factor in a large population of LSS patients. It has been reported that the majority of LSS patients have hypertrophy of the LF and that its thickness may account for 85% of lumbar spinal canal narrowing.” (Pain Practice, 2012)

We believe that the MILD procedure has proven that we can treat one causal factor of LSS with a minimally invasive approach that is safe and effective. By treating the underlying cause of the condition we can provide improved quality of life for a large and growing elderly population that do not consider open decompression procedures as viable treatment option. For these patients who feel they have no options, we strongly suggest a positive National Coverage Determination for PILD, or MILD.

Respectfully,

Interventional Pain Management Physicians of Southern Nevada

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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 and Radiology at the University of Michigan, faculty member since 1995, and I currently serve as the Associate Chair for Research in its Department of Psychiatry. I have authored over 135 peer-reviewed articles, most of them in premier journals in the neurosciences, and serve as reviewer to over 60 journals in the field. One of the lines of work in our laboratory is the study of mechanisms associated with the formation of placebo effects (placebo analgesia), with 14 original manuscripts and 35 invited presentations in national and international conferences on the topic. This work, together with other lines of research in the laboratory, is funded exclusively through federal sources, primarily the National Institutes of Health. Our laboratory, here at the University of Michigan, has pioneered the study of the neurobiology of placebo effect formation (primarily as it relates to pain) and therefore I am objectively considered an expert in the area of potential confounds that can be present in clinical trials. In the context of this letter, I have performed an extensive review of the pertinent literature using PubMed and examining all published data on surgical approaches to back pain.

At the present time, there are no placebo-controlled trials for surgical interventions for back pain. It is therefore not possible to precisely estimate the exact placebo response rate in this condition. Placebo responses have been best documented in experimental settings under controlled conditions where expectations and non-specific effects can be manipulated and evaluated (Zubieta and Stohler 2009, Finniss, Kaptchuk et al. 2010). There is a general consensus, however, that placebo responses vary substantially between pain conditions (e.g., high in functional bowel disorders, moderate in fibromyalgia, low in osteoarthritis) and are further influenced (diminished) by disease chronicity. A recent meta analysis of randomized studies examining the effects of placebo in all pain conditions across 60 studies involving 4154 patients worldwide showed small effect sizes in controlled trials, with standardized mean differences in pain report ranging from 19-36% (mean 28%) across all painful conditions (Hrobjartsson and Gotzsche 2010).

In the only randomized study specifically studying PILD (Brown 2012), this procedure was compared against epidural steroid injection. The latter procedure could then be considered an “active” control, with effects that would include both a placebo response as well as the potential benefit of the steroid administration, and it was associated with an average improvement in pain report of 10% from baseline to week 6, a small effect size. PILD was associated with a 25% improvement in pain report during the same period.

In terms of comparability to other invention studies, six trials have examined the effectiveness of surgical treatments against non-surgical treatment (indication trials): Various forms of lumbar fusion (Fritzell, Hagg et al. 2001, Brox, Sorensen et al. 2003, Fairbank, Frost et al. 2005, Brox, Reikeras et al. 2006, Ohtori, Koshi et al. 2011), or surgery with disc prosthesis (Hellum, Johnsen et al. 2011). In Fritzell et al. (2001), it was reported on a sample of 294 patients across 19 centers. This study documented a 7% reduction in pain report in the nonsurgical group (standard forms of physical therapy), and a 33% improvement in the surgical group. Disability (Oswestry Low Back Pain Questionnaire) was reduced by 6% in the physical therapy group and 25% in the surgical group. Brox et al. 2003 and 2006 (64 and 60 patients, respectively) reported no differences between lumbar fusion and an active control group of cognitive therapy and structured exercise. Fairbank et al. (2005) reported on 349 participants who were randomized between spinal fusion surgery and an intensive rehabilitation program and found minimal differences between the two treatments. In Hellum et al. (2011), 173 patients were randomized to surgery with disc prosthesis or outpatient multidisciplinary rehabilitation with significantly greater improvements in the surgical group in the Oswestry index compared to the rehabilitation group at 2 years, with a 12% difference in pain report in favor of this surgical procedure. In a small study that included a minimal treatment control, this was compared to two different forms of spinal fusion. While superiority of the active treatment groups was reported, changes in pain report in the control group were not described in the Ohtori et al. (2011) article.

The above information, primarily based on the only large intervention study that did not utilize an active control group beyond standard physical therapy (Fritzell et al., 2001), indicates that recovery in persistent low back pain is very low (average of 6-7% reduction in pain report and disability) in the absence of an active treatment condition beyond physical therapy.

This literature review indicates the absence of exact estimates of the effects of placebo, natural history and regression to the mean in persistent back pain. However, based on the information available from the limited number of randomized trials in this disorder, these effects appear low, even when a potentially active condition (e.g., epidural steroid injection, Brown 2012; standard physical therapy, Fritzell et al., 2001) is compared against an intervention. On the contrary, the data available for PILD suggests significant improvements in both pain report and disability ratings which exceed the expected cumulative rate of placebo response, regression to the mean and changes due to natural history expected in persistent low back pain.

Thank you for allowing me to comment on this decision.

Jon-Kar Zubieta, MD, PhD
Phil F. Jenkins Professor
Professor,
Departments of Psychiatry, Radiology and Neurosciences Program
Research Professor, Molecular and Behavioral Neuroscience Institute
The University of Michigan

References:

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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. Results of this survey by our medical executive committee are quite good and at 6 months or greater interval the data revealed 79.7% of patients had improved functionality, 71% showed decrease in pain meds, and 89% had a decrease in pain scores. In addition none of the patients surveyed went on to have more invasive spinal surgery.

All procedures were performed in an outpatient setting. All patients went home on the same day. No patients required general anesthesia. There were no adverse events – i.e. no nerve injuries reported, no bleeding requiring transfusions occurred, and no infections.
The majority of these patients had comorbidities that made them poor candidates for general anesthesia, so this treatment was there only option for pain relief. Beside retirees being able to quickly have a better quality of life (due to the pain reduction), several professionals including MDs, attorneys, dentists, pharmacists... were able to return to work within a week.

Based upon my extensive experience with this procedure and the independent follow-up by the hospital’s medical executive committee, it is my professional opinion that the mild procedure is:

I suspect that after your research on LSS for this NCA, you have realized that you may have a family member or have seen people that exhibit LSS symptoms that could potentially benefit from this procedure. I encourage you not to deny those individuals (our elderly population) this treatment.

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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™ Direct Decompression System, a new technology indicated to perform minimally invasive direct decompression of the lumbar spine.¹ A clinical study to evaluate the health outcomes of the Totalis™ Direct Decompression System is under development, and we believe it will answer the Center for Medicare & Medicaid Services evidence-based questions as to whether PILD surgeries can be reasonable and necessary. Therefore, we respectively request that CMS establish a process for Coverage with Evidence Development (CED) to allow for the opportunity to collect robust data on this new technology.

The Preliminary Decision Memorandum includes a review of a new technique for the treatment of LSS, which uses percutaneous image-guided lumbar decompression without direct visualization of the surgical area. The memorandum states that the procedure that most closely falls under the description of the new technique is known commercially as the mild® procedure (Vertos Medical). However, the mild® procedure does not appropriately represent the range of clinical procedures that are classified under the broad heading of PILD for LSS, such as the Totalis™ system. The Totalis™ procedure is quite different than mild® although it still falls in the same PILD category. The Totalis™ procedure offers a broader decompression of the offending tissue which generates the symptoms of spinal stenosis. Therefore, we urge caution in finalizing a coverage decision for the whole class of procedures based upon the data of mild® alone.

Preliminary clinical experience with Totalis™ Direct Decompression System is promising, and early results warrant a robust clinical study appropriate for CED. VertiFlex Inc. has developed a draft protocol that we believe will meet CMS’s requirements for CED. We are committed to engage in a multi-stakeholder process to finalize the study design. Therefore, we request that CMS state in the Final Decision Memorandum for CAG #00433N that the Agency is open to CED for appropriate clinical studies of PILD systems for LSS meeting criteria consistent with the CED draft guidance.

CED is designed to address coverage of items and services that are believed to be promising, but whose ultimate impact on Medicare beneficiary health outcomes remain unconfirmed. It is appropriate to establish coverage under CED for clinical studies of PILD systems for LSS, such as the Totalis™ Direct Decompression System. Early clinical experiences of Totalis™ are promising, but assessments of the impact on Medicare beneficiaries have yet to be conducted.

In a recent Decision Memo that established CED for autologous blood-derived products for chronic non-healing wounds, CMS stated that it determines the appropriateness of a CED coverage determination based on three factors:

1. Basic safety of the proposed item or service
2. Potential to benefit Medicare beneficiaries
3. Difficulty of conducting adequate trials

The basic safety of the Totalis™ system has been established through the FDA clearance process and through early clinical experiences. Medicare beneficiaries may benefit, as demonstrated by the early clinical experience of PILD procedures, including Totalis. Additionally, Medicare patients who are unable or unwilling to undertake the risk and trauma of larger decompression surgery may also benefit from this less invasive option. We recognize evidence is yet insufficient, but further study is warranted given the preliminary experience. Finally, in terms of the effort and expense required to conduct an adequate trial, it is difficult for a small company to organize and fund a robust clinical study comparing newer innovations with more-established procedures for lumbar spinal decompression.

Without less invasive options, patients will continue to be driven to more open, invasive and risky surgeries.

We appreciate your consideration of this request. We will be meeting with the Coverage and Analysis Group to discuss the possibility of CED in greater detail. Please do not hesitate to contact me if you have any questions or comments. I can be reached at (949) 940-1433 or efender@vertiflexspine.com.

Sincerely,

1. Totalis™ Direct Decompression System was cleared by the Food and Drug Administration (FDA) on November 13, 2012 under a 510(K). The system utilizes VertiFlex' proprietary interspinous access platform and includes both reusable and disposable instruments to remove bone and soft tissue. Key Features of the Totalis™ System Include: (1) single midline cannula access; (2) bilateral access to the posterior lumbar spine through the interspinous space; (3) ability to remove ligament, bone, facet joint, and cyst, and (4) MIS instruments designed for precision and safety.

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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 technique on our patients. The results have been significant and reproducible. This procedure has been able to bring back functionality to our patients at a fraction of the cost and morbidity of alternative and more invasive procedures.

I implore CMS to do the right thing and continue to support this procedure.

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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 spectrum. Many of these patients are poor anesthetic and surgical risks.

Percutaneous image guided lumbar decompression offers patients a safe, effective option for the permanent treatment of lumbar spinal stenosis, without the risk of major surgery. In my practice, I have performed 85 such procedures, with excellent results, and literally zero complications. Of these 85 patients, roughly 80% of them have experienced a significant reduction (75% to 100%) in pain, and a global improvement in overall function. Patients are able to walk longer distances, with less symptoms of claudication, and are able to perform many of your activities of daily living without pain.

The five most recent patients that I performed minimally invasive lumbar decompression/PILD on have responded with disgust when I explain to them that CMS would potentially no longer be funding the procedure. I also explained to them that part of the rationale behind potentially discontinuing funding was the high likelihood / high probability of the placebo effect in this and all interventional pain management procedures (as asserted by CMS). Most patients responded to that notion with laughter.

If cost containment played a role in this (potential)decision, there is no better example of a governmental body being penny wise but pound foolish. The overwhelming majority of patients that I have performed this procedure on no longer return for lumbar epidural steroid injections 3 to 4 times a year. The same patients no longer require medical management with neuropathic agents, or opiate pain medications. Further, they do not require physical therapy. I would argue that with PILD, CMS would actually realize a cost savings for these patients.

At the end of the day, if the decision is upheld to no longer fund this procedure, the true losers are the patients in need of this therapy; the same group of patients that CMS purports to protect.

Please reconsider this draft decision.

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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 commitment to participation in public programs.

General Comments

AHIP and our member health plans encourage CMS to ensure that all patients receive safe, effective and evidence-based healthcare services. The current evidence for use of percutaneous image-guided lumbar decompression for lumbar spinal stenosis emphasizes that the clinical criteria for establishing the diagnosis of lumbar spinal stenosis are not standardized and thus could potentially lead to misuse. There is only one prospective randomized controlled clinical trial which compares the procedure to injection of corticosteroids. Although the results of this single study show a benefit for the procedure vs. corticosteroid injections, there are no direct studies comparing image-guided minimally invasive lumbar decompression to other surgical modalities, including the standard intervention of laminectomy and fusion.

In 2010 the American Association of Neurological Surgeons completed a technology assessment of percutaneous image-guided minimally invasive lumbar decompression procedure. While it did not make recommendations for or against the use of this procedure, the Association indicated at that time, only two non-randomized publications (level III evidence, retrospective studies) were available and that no definitive statements could be made concerning indications, efficacy, outcomes, or complications. Further studies with sufficient sample size and follow-up are needed to establish the safety and effectiveness of percutaneous image-guided minimally invasive lumbar decompression.

Therefore, our member health plans support the proposed decision of CMS not to cover this procedure. Thank you for the opportunity to comment on this important issue.

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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 the safety, efficacy, and relative affordability of this procedure.

The safety of any interventional spine procedure is of paramount importance. The mild procedure is safe due to the effective design of the equipment that minimizes the chance of a dural tear, the use of fluoroscopy to again minimize the chance of a tear, and the training for this procedure that reduces the chance of an adverse outcome. The numerous studies related to mild confirm the excellent safety profile for this procedure.

The mild procedure is effective for the properly-selected patient. In my experience, patients who have not wanted to undergo a laminectomy for one of a variety of reasons and who may be poor candidates for general anesthetic may benefit greatly from the mild procedure. In particular, this is if they have clear symptoms of spinal stenosis that correlates with overgrowth of the ligamentum flavum in their spinal canal as can be seen in a lumbar MRI. These patients frequently obtain temporary benefit from epidural steroid injections and then obtain significantly longer duration of pain relief from the mild procedure that targets the structural cause of their spinal stenosis.

My patients appreciate how minimally invasive the mild procedure is, how they can stand without discomfort and how they can walk longer distances after this procedure. They also do not incur the cost of a laminectomy, the intraoperative blood loss, or the general anesthetic risk associated with such a surgery.

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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 were not candidates for the open procedure. Obviously this is meant to either save money or satisfy political interests of the surgeons; the elderly, apparently will be left to fend for themselves. This makes no sense from a scientific point of view, based on my reading of the literature.

Sincerely,

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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 within days the patients are able functional.

this procedure passes the YO Momma test. I would have my momma have the PIGDL done before a major decompression laminectomy with months of recovery.

This is a common sense approach to cutting cost.

Sincerely

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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 LSS I have a very clear algorithm. After a thorough H&P, and hearing of classic neurogenic claudication symptoms like standing and walking difficulties that improve upon bending forward or resting I look for at least moderate ligamentum flavum thickening on MRI. I have found this procedure to be extremely helpful in those patients who are otherwise not good surgical candidates for open laminectomy (especially the elderly) and question why, in an environment where healthcare dollars are at a premium, we continue to stifle proven, cost-saving innovations. Please consider coverage of this truly medically necessary, reasonable procedure.

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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% responder rates in my practice. All of which note improved standing/walking time, further emphasizing the ability to treat neurogenic claudication by way of the MILD procedure.

I believe that MILD serves a critical role to fill the gap in the treatment algorithm for patients with symptomatic lumbar stenosis secondary to ligamentum hypertrophy. These are often elderly patients that respond to conservative therapies, such as epidural steroid injections, but see limited duration of their effects. Additionally, the MILD procedure opens up treatment options for a significant number of patients experiencing neurogenic claudication, in which open laminectomy is not an option.

The body of evidence, both from my personal practice and the published peer-reviewed literature, strongly supports the continuation of coverage for this procedure. MILD has been well-documented as safe, with far less of a complication rate when compared to open laminectomy. In my personal practice, I have had no adverse events related to the MILD procedure. It affords the appropriate candidates the opportunity to see almost immediate results with little, if any, recovery time. The durability of the procedure has also been demonstrated in the literature out to two years post-procedure.

From my perspective, the mechanism of action is quite clear. Ligamentum flavum hypertrophy has long been understood as a major complicating factor in LSS and neurogenic claudication and is simple to diagnose utilizing patient symptoms and imaging. The MILD procedure targets a very specific, but debilitating cause of LSS with considerable precision and efficacy.

I would urge CMS to reconsider the coverage of the MILD on the basis of the patient outcomes and the medical community’s demand (as seen by the comments provided by supporting physicians and their treating societies). To date, thousands have been treated, many of whom continuing to show durable long term results. Medicare beneficiaries deserve access to MILD- it is a safe, durable and cost-effective solution for LSS patients with neurogenic claudication.

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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 our patients. This will often require questioning the norm to ensure technology has every opportunity to grow within our industry. To admit we do not know everything is worth the sacrifice for new treatment opportunities. I have performed six PILD procedures and am impressed by my patient outcomes. Although, CMS may consider this a small number, I see it as six patient lives have been restored to some form of normal function that of which these patients lacked prior to the PILD. I am perplexed and disappointed that CMS is considering removing this technology.

In an article written by Deyo (2010) Researchers conducted a retrospective analysis. He states “It seems implausible that the number of patients with the most complex spinal pathology increased 15-fold in just 6 years.” In 2007 Consumer Reports rated spinal surgery as the number 1 on its list of overused tests and treatments. At what point will this be reviewed and addressed? CMS has no National Coverage Determination open for open decompressive or spinal fusion procedures, why is the PILD procedure subject to such scrutiny with far fewer complications, impressive outcomes, and cost efficiencies? Can you not consider why the Physician community along with the Medicare beneficiary population would not question this? I question what CMS would consider best possible outcome for this growing patient population. With unrealistic controls on new technology and no controls on existing technology CMS will continue to spend considerably and at the cost of the Medicare beneficiary.

1. Deyo R., Complex Operations for Spinal Stenosis Increasing Despite Complications, Journal of American Medicine 2010; 303:1259-1265.

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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. ASIPP does not support the draft analysis and urges CMS to issue a favorable National Coverage Decision. There are several concerns raised in the NCA draft that relate to pain studies in general, the data for the mild procedure, and LSS treatments that we would like to address.

Lack of consensus on diagnostic criteria

The NCA expressed a concern over diagnostic criteria for LSS treatments in general and applied that concern to the studies conducted on mild. The NCA cited studies such as Sandella, et al. which stated that “There is no “gold standard” for diagnosis and treatment of stenosis because of variable signs and symptoms, physicians’ history-taking and physical methods and diagnostic tests” and concluded that “Given the many conditions that lead to complaints of back pain, the consistent application of explicit and reproducible diagnostic criteria are needed to assure that patients in clinical trials are comparable to patients in community settings who may be labeled with the same diagnosis but who may have other causes of back pain.” (1)

We disagree with this characterization as it applies to PILD and also disagree with the foundation used to arrive at this conclusion. The NCA’s conclusions and cited studies refer to general categories of “back pain” and “LSS” and it is unclear from these studies whether the researchers were referring to all LSS or LSS with neurogenic claudication and hypertrophic ligamentum flavum, which is what PILD treats. This is important because neurogenic claudication has a clearly understood symptomatic diagnosis. The symptoms are a limitation in the ability to stand or walk for extended periods of time due to pain/numbness in the back or legs and the discomfort is relieved with flexion. The same source listed by the NCA (Sandella) actually indicated that a physician can become “almost 90% certain a person has clinical spinal stenosis” within 5 questions. The top 3 questions were “leg pain while walking” (66%), “must sit down” (66%), and “flex forward while walking” (49%). It is not clear whether the other studies cited by the NCA specifically looked for neurogenic claudication symptoms. For example, Haig et al. identified patients that experienced back pain after a 15 minute ambulatory test but it is unclear whether the test included a measure to determine whether pain was relieved upon flexion or sitting, which is a key component on neurogenic claudication identification (2). Kurd analyzed patients from the SPORT study, whose enrollment criteria included patients with neurogenic claudication AND radicular pain (3). De Graaf, et al. did not restrict their systematic review to studies that looked at neurogenic claudication (4). As a matter of fact the de Graaf study looked at publications that included central, lateral, and foraminal stenosis with no limitation to the causes of the stenosis. This is not comparable to the PILD group, which requires a defined symptomatic diagnosis of neurogenic claudication followed by a confirmation of hypertrophic ligamentum flavum through imaging. The experience of the treating physicians and the clinical studies on mild indicate there are clear diagnostic criteria for the PILD patient group.

Lack of consensus on the treatment of LSS

The NCA cites a lack of consensus on the treatment of LSS as a reason for the non-coverage recommendation on PILD and then goes on to state that “For patients with more severe symptoms surgery is an option. In addition to open techniques, there are minimally invasive techniques for laminectomy.” We are perplexed by this statement for several reasons. First, citing therapies like “minimally invasive techniques for laminectomy” as options seems contrary to the fact that the published record on these therapies does not meet the clinical evidence standards set forth in the NCA. Secondly, the statement ignores the treatment gap that exists between conservative treatments (including pharmacological intervention) and surgery. There are many patients that are not suitable surgery candidates and/or cannot tolerate anesthesia due to comorbidities and advanced age. The majority of these patients have no other treatment options besides PILD. Lastly, it seems contrary to best practices in patient care and optimal use of health care resources to advocate an escalation from conservative treatments to surgery without consideration of more minimally invasive options like PILD, especially when the efficacy evidence for these more invasive therapies does not exceed that of PILD and the risk factors are greater.

The required standard for pain procedures

The NCA asserts that there are numerous uncertainties to treating lumbar spinal stenosis and pain that consequently require a high evidence standard in order to properly evaluate efficacy. The main reasons cited are: lack of consensus on LSS diagnosis criteria and the susceptibility of the placebo effect for pain procedures. This has led CMS to conclude that “The general reliance on case series rather than robust randomized sham controlled clinical trials with explicit protocol driven criteria further limits the persuasiveness of the evidence.”

We disagree with the foundation for the standard of evidence, the requirement of “randomized sham controlled trials”, and the characterization of the mild data as “case series” and would like to address each in turn:

1. The foundation for the standard of evidence: lack of consensus on LSS diagnosis criteria, & the susceptibility of the placebo effect for pain procedures

Our comment has previously addressed the concern over the lack of consensus on LSS diagnosis criteria. The issue of the placebo effect has been discussed in the peer reviewed literature but a thorough systematic review of long term placebo effects on interventional pain studies has not been done to our knowledge. The JAMA article by Beecher is often cited to indicate that 35% of patients may experience therapeutic benefit as a result of the placebo effect (5). A limitation of this article is that it does not address the issue of long term placebo effect or demonstrate that these “therapeutic benefits” have achieved a clinically meaningful difference (CMD) threshold so the 35% number can be considered to be a high number. Given this information, it is hard to attribute the therapeutic benefits seen with the mild procedure to a placebo since, according to Levy, et al., “One hundred and thirty-four patients comprise the Year One population, 81% of which were considered responders. In these patients, baseline VAS was 7.4 and Year One VAS was 3.5, yielding a mean pain improvement of 3.9 (+/- 0.42, 95% CI). Likewise, their mobility at 1 year was significantly better than at baseline, improving from 46.6 to a Year One mean of 30.6, a 16.0-point improvement” (6). These high responder rates and statistically significant / clinically relevant results were achieved in studies that were specifically designed to reduce bias. Almost all of them had multiple, validated outcomes measures such as ZCQ, SF-12, VAS, ODI, PDI, & Roland-Morris Questionaire. All studies showed statistically-significant improvements and clinical relevance using multiple instruments. In addition, the studies were conducted over multiple study sites (14 centers in the MiDAS I study) so it seems difficult to conceive that outcomes measure bias could have been repeated across multiple sites using multiple validated outcomes measures. Finally, the results seen in the Brown RCT should be of particular interest to the issue of bias. In this blinded study, pain reduction at 6-week follow-up was statistically significantly better for patients treated with mild versus those treated with ESI. Further, 100% of the control group (ESI treatment) crossed over to the PILD procedure after study’s end and their pain reduction at 6 weeks was very similar to that experienced by the originally assigned mild–randomized cohort (7). This result is hard to explain on the basis of placebo effect.

In summary, attributing the benefits seen in the mild procedure data to placebo effect or some other bias seems to be difficult to explain given the high responder rates and clinically relevant / statistically significant results over multiple long term studies and multiple study sites, including a randomized control trial.

2. The requirement of “randomized sham controlled trials”

We agree that randomized control trials are desirable in many circumstances but we also want to point out that they are not appropriate in certain circumstances. When considering the options for conducting a Randomized Controlled Trial (RCT) with PILD, there are no study design options that could be conducted successfully. The three types of RCTs that could be considered are an Active Intervention Control study, a Sham study, and No Intervention Control study.

The possibilities for an Active Intervention Control RCT include conservative therapy or decompression surgery. Conservative therapies, including ESI, have been shown to provide only temporary pain relief for LSS patients suffering from painful neurogenic claudication. Offering patients a randomization design with temporary therapy in one arm and permanent therapy in the other is not practical, and patients would not agree to be randomized into this study design. Further, the large majority of patients seeking treatment from interventional pain physicians have already failed conservative therapy, including ESIs. This results in an immediate bias if patients actually agree to be randomized since they have already failed ESI therapy. Alternatively, identifying patients prior to ESI treatment is also impractical because patients are generally referred to interventional pain physicians after failing conservative therapy, including treatment with ESIs. And finally, ESIs are most often administered as a series of injections over six to eight weeks, which eliminates the possibility of blinding.

Alternatively, surgical decompression procedures including laminotomy, laminectomy and fusion are performed by completely different physician specialties—generally orthopedic surgeons and neurosurgeons. The impediments to randomizing patients into a study where different physicians perform each of the treatment arms are numerous and extremely difficult to overcome. By definition, the results would be confounded by the fact that different physicians would be performing each treatment. Further, there would be no possibility of blinding, and the difficulty of identifying an adequate number of sites offering collaborative physician groups in the two treating specialties would be next to impossible. Lastly, as part of the informed consent process and IRB approval, the patient would have to be notified of the two treatment options and their significantly different safety profile. It is difficult to envision a situation where a patient would agree to randomization in a study with therapies that have such different safety profiles if they are a candidate for both procedures. These obstacles are significant, and together with the certain difficulty of convincing patients to agree to this type of randomization, renders this option unfeasible.

A sham study design, conducted for the purpose of eliminating placebo effect and maintaining patient blinding, would require all patients to undergo preliminary access steps of the PILD procedure, including placement of the access port. Actual PILD treatment, whereby small amounts of lamina and ligament are removed through the portal, would only be performed on patients randomized to the PILD treatment arm. While the PILD port is very small, any intervention exposes the patient to risk of infection, and other minor complications. Ethically, it is difficult to justify placing the PILD port in the lumbar spine, and then not treating the patient. Further, patients would be very opposed to undergoing a minimally-invasive lumbar spine procedure, while potentially not receiving therapy that could relieve their pain symptoms and staying in a “no therapy” cohort for an extended period of time. And finally, a No Intervention Control RCT design would require patients randomized to the control group to receive no treatment. Since these patients have already failed conservative therapy, it would be a step backwards for them to then receive no treatment at all. It is difficult to imagine that patients would agree to this type of randomization, except for the very short-term.

There are no viable options for an RCT design comparing PILD to a concurrent control group.

3. The characterization of the mild data as “case series” and “weak”

The NCA has classified the data available for the mild procedure as “case series”, which based on Appendix A “General Methodological Principles of Study Design” provided with the NCA, places it 7th out of 8th place on the ranking of research design, which is below retrospective case control series and surveillance studies. This appears to be inconsistent with the fact that the studies were prospective and used multiple validated outcomes measures to reduce bias. This also seems very inconsistent with Levels of Evidence guidelines for AMA’s CPT process (which is based on AHCPR 1992). The table below shows this scale:

Based on this categorization, the mild body of evidence would consist of one “1b”, six “IIb”, and three “IV” studies (see table below). While CMS may have its own method of evaluating clinical evidence, it is relevant to note that the CPT Category I code application requires that at least one publication must meet or exceed the criteria for Level lII. Clearly, PILD exceeds these criteria as there are currently seven studies and eight publications rated higher than Level III. That two different evaluation systems used to establish coverage can yield such different conclusions on the strength of the evidence is striking. Furthermore, it is difficult to categorize the appraisal conducted by CMS in the Proposed Decision Memo as a systematic review since no methodology was described and a well-accepted Level of Evidence grading scale was not applied. This creates issues with the interpretation of the evidence and characterizations that the evidence is “weak”. Specifically, characterizing multiple well-designed, prospective, multi-center, non-randomized studies with one to two-year follow-up as employing less rigor than “retrospective case control studies” and “surveillance studies (registries or surveys)” seems to be illogical. As such, we disagree with CMS’s characterization of the studies and the subsequent conclusion that the studies are “weak”.

Level of Evidence Type of Evidence:

1. Double-blind, Randomized, Prospective Study of ESI vs. mild (One Center / 38 Patients)

IIb
Well-designed prospective, multi-center, quasi-experimental study:
1. MiDAS I (14 Centers / 78 Patients)
2. MiDAS II (8 Centers / 55 Patients)
3. MiDAS III (22 Centers / 122 Patients)

Well-designed prospective, single-center, quasi-experimental study:
4. Mid-Ohio Neurosurgical Care, Mansfield, OH / Chopko (One Center / 14 Patients)
5. The Center for Pain Relief, Charleston, WV / Deer (One Center / 46 Patients)
6. Cleveland Clinic, Cleveland, OH / Mekhail (One Center / 40 Patients)
IV Prospective, multi-center, pilot case series:
1. Procedure Description and Case Series / Wong (Five Centers / 17 Patients)

As a final point, we would like to comment on items that the NCA did not mention but should be part of an evaluation of this therapy. We discussed earlier in this comment how this therapy filled a treatment gap between conservative treatments and surgery. This view has been echoed in numerous comments to the NCA but not acknowledged by CMS in its analysis. Additionally, we would like to bring to CMS’s attention the reduction in health care resources that this therapy offers. In our comment in April we indicated that a “recently-published article by Wang et al. in April 2013 in the peer-reviewed journal, Pain Medicine, titled “Decrease in Health Care Resource Utilization with MILD” reported a 45% reduction in time spent in specialty care and an almost fourfold decrease in number of interventional pain procedures performed on patients with lumbar spinal stenosis. Further, over half of the patients who had undergone the mild procedure no longer required chronic pain management to treat LSS symptoms. These authors conclude that mild is not only a reliable method to treat LSS, it also appears to reduce the consumption of limited health care resources (8).” It appears that this was not considered in the NCA but it is an important potential benefit based on the numerous comments and experiences of our physicians.

In conclusion, we would like to reiterate our stated support of this procedure. We do not believe that NCA presents an accurate depiction of the clear diagnostic criteria in use for evaluating PILD patients, sets an appropriate standard of evidence for interventional pain procedures, accurately reflects the evidence on the mild procedure, addresses the treatment gap that exists in LSS treatments (and is filled by mild), or considers the lower use of health care resources this procedure provides. We, therefore, urge CMS to reconsider its position.

References

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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 life of patients.

To this end, we believe that CMS should consider the large and growing elderly population who are either unwilling or unable to tolerate general anesthesia and the potential adverse effects associated with open decompression procedures. It is necessary to introduce less-invasive therapy options that treat the underlying cause of the condition to provide long term relief. Conservative medical management is not a long term treatment option for this subset of lumbar spinal stenosis patients that have neurogenic claudication. To suggest that medical management is a treatment option for these patients will only contribute to the prescription drug abuse problem in America.

The MILD procedure offers this subset of patients, those with lumbar spinal stenosis with neurogenic claudication, a viable treatment option that can improve their quality of life. Patients with neurogenic claudication presents with distinct clinical symptoms. An MRI can confirm the clinical symptoms to show the level and severity of the stenosis. This same diagnostic process, including clinical symptoms and MRI confirmation, is how surgeons are diagnosing LSS and performing laminotomies, laminectomies and fusion. This begs the question: why would the MILD procedure need to have a more strict diagnosis requirement than the already covered and broadly used CMS surgical procedures that treat the same condition? To quote the SPORT study, “all patients had neurogenic claudication and/or radicular leg symptoms; confirmatory cross-sectional imaging showing lumbar spinal stenosis at one or more levels; and were judged to be surgical candidates.” (New Engl J Med, 2008)

Rarely do elderly patients present with hypertrophic ligamentum flavum only. This is a degenerative condition, so the stenosis can also be caused by disc bulge, osteophyte formation, etc. which also impinge upon the canal. If the hypertrophic ligamentum flavum is a predominant factor of the stenosis then MILD can help these patients. In the article on Cleveland Clinic study, it stated “review of these patient MRIs usually reveals that the cause of symptomatic LSS is multifactorial in nature. Disk bulge, facet hypertrophy, and invariably, ligamentum flavum (LF) hypertrophy, which compromises the central canal, are commonly found. Clearly, it is not necessary to correct every casual factor in a large population of LSS patients. It has been reported that the majority of LSS patients have hypertrophy of the LF and that its thickness may account for 85% of lumbar spinal canal narrowing.” (Pain Practice, 2012)

We believe that the MILD procedure has proven that we can treat one causal factor of LSS with a minimally invasive approach that is safe and effective. By treating the underlying cause of the condition we can provide improved quality of life for a large and growing elderly population that do not consider open decompression procedures as viable treatment option. For these patients who feel they have no options, we strongly suggest a positive National Coverage Determination for PILD, or MILD.

Respectfully,

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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 preserve coverage for interventional pain management procedures and patient access to these procedures we need to ensure that mild and other procedures like it that are well studied with proven safety records gain positive CMS national coverage. mild should be an available treatment option for the subset of lumbar spinal stenosis (LSS) patients with neurogenic claudication that have hypertrophic ligamentum flavum as a predominant cause of their symptoms. These patients need a safe alternative treatment option to open decompression surgery and mild is the alternative.

This procedure is perfect for the skillset of the interventional pain physician with the minimally invasive and fluoroscopically guided approach, which also makes it an ideal treatment option for the elderly patient population that cannot or does not want to undergo general anesthesia or major invasive open surgery. mild has been established to treat a condition, neurogenic claudication, that affects millions of Americans and severely limits function and ability to conduct activities of daily living.

Cumulatively Dr. Buenaventura and I have treated over 100 patients with mild. I, Dr. Soin, have been treating since 2010 and I have firsthand account of patients that have experienced durable pain relief and mobility improvement lasting two years. These results cannot be attributed to a placebo effect. When a patient that could not walk 10 feet with the aid of a walker prior to the mild procedure can now walk over a mile without the assistance of a walker it is not a placebo effect. For over 500 patients included in the clinical studies on mild that have experienced safe and efficacious outcomes that have lasted one year and two years post procedure, this cannot be questioned as a placebo effect. In Dr. Lora Brown’s 38-patient study comparing epidural steroid injections (ESI) with the mild procedure for treatment of back pain caused by LSS, mild was shown to be more effective and safe. The average VAS improvement for patients receiving mild was a statistically significant 2.5, while the average VAS improvement for the ESI group was not statistically significant 0.1. (Pain Practice, 2012) This direct comparison rules out any possibility of a placebo effect.

It seems that CMS would like there to be a direct comparison study of mild vs. open decompression surgery, one that is blinded and randomized. No Institutional Review Board would find this to be an ethical comparison due to the risks of the open decompression compared to the minimal risk of the mild procedure. No patient would choose to be randomized to the open decompression surgery once the risks are explained.

Although treatment of LSS has historically been reserved for the ortho or neurosurgeons there is now a new minimally invasive (interventional) approach that inherently makes the procedure, safe, cost-effective and easy to recover from. I urge you not to make this coverage policy based on which physician should be treating this condition for this patient population but rather on the proven safety and efficacy of the mild procedure.

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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, questions about adverse events and conflicts of interest. Your conclusion; that the evidence does not support a conclusion of improved health outcomes for our Medicare beneficiaries. I am astounded at the sheer ignorance in your conclusion and call to question CMS’ understanding and ability to execute decisions for its Medicare population.

CMS states “It appears consensus as to the definition of spinal stenosis has not been reached among experts. There is no “gold standard” for diagnosis and treatment of stenosis because of variable signs and symptoms, physicians’ history-taking and physical methods and diagnostic tests. (Sandella et al. 2013). What CMS fails to identify in this same report, Sandella et al. state “Although narrowing of the spinal canal is considered the hallmark of stenosis, the diameter of the spinal canal varies so greatly among patients that no acceptable point of demarcation exists between asymptomatic and symptomatic persons. The report further goes on to say that “Syndromes are sets of rules. In the past, the development of rules for syndromes largely has been conducted by expert panels. Although these panels often are well informed by previous literature and personal experience, it is presumptive to believe that such panels have a better perspective than the collective wisdom of hundreds or thousands of clinicians or, that they represent common beliefs”. I stand firm in my belief that the PILD procedure is safe and effective. As a treating Physician, I see many patients who suffer ailments such as spinal stenosis. Each patient presents with different signs and symptoms, complaints, and therefore their treatment plan is varied based on their tolerance to treatment. I additionally stand firm in my belief that the best treatment algorithm is best left up to the clinicians treating these patients every day and not a panel of individuals who have had limited exposure to patient care.

With the above-mentioned noted, I refer to the article written by Deyo et al. “Trends, Major Medical Complications, and Charges Associated With Surgery for Lumbar Spinal Stenosis in Older Adults”. The author states “In planning spine operations, surgeons have wide discretion. For pain-related surgery, consensus on indications for specific procedures e.g. decompression alone or decompression plus fusion is generally lacking despite randomized trials for some condition and procedure combinations. Additionally, individuals surgeon preferences may outweigh patient and disease characteristics in choosing procedures”. As I began to read this article, I came to question why CMS would find it necessary to put a significant choke hold on the clinical studies, patient outcomes, and overall performance of the PILD procedure, yet this article points to a very lax approach to laminectomy and/or spinal fusion. In the midst of this proposed debacle, a conscience effort was made to identify the limitations and guidelines for spinal laminectomy and laminectomy with fusion. To my astonishment, there is no National Coverage Determination and only one Local Coverage Determination setting parameters and guidelines for open decompression surgery. The PILD procedure is less invasive, more cost effective, and by far is light years away in its safety and efficacy than an open laminectomy/fusion.

I cannot help but question what this panels intentions were when presenting this proposal. I therefore reviewed the only LCD from Florida and found that the parameters for coverage for laminectomy/fusion is as follows; Spinal fusion is indicated for Spinal stenosis for a single level (for example, L4-L5) with associated spondylolisthesis (see classifications below in section III) or other documented evidence of instability (for example, facet joint instability [iatrogenic] related to decompression), AND symptoms of spinal claudication and radicular pain. The pain must represent a significant functional impairment despite a history of 3 months of conservative therapy (non-surgical medical management) as clinically appropriate addressing the following:

• Activity lifestyle modification
• Daily exercise
• Supervised physical therapy (PT) (activities of daily living [ADLs] diminished despite completing a plan of care)
• Anti-inflammatory medications, oral or injection therapy as appropriate, and analgesics

I cannot help but wonder why the PILD procedure is held to a standard higher than a more invasive procedure with limited criteria. Further, your CMS Medicare Integrity Manual states the following with regards to the creation of coverage determinations;

Contractor LCDs shall be based on the strongest evidence available. The extent and quality of supporting evidence is key to defending challenges to LCDs. The initial action in gathering evidence to support LCDs shall always be a search of published scientific literature for any available evidence pertaining to the item or service in question. In order of preference, LCDs should be based on:

Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and General acceptance by the medical community (standard of practice), as supported by sound medical evidence based on:

• Scientific data or research studies published in peer-reviewed medical journals;
• Consensus of expert medical opinion (i.e., recognized authorities in the field); or
• Medical opinion derived from consultations with medical associations or other health care experts.

Acceptance by individual health care providers, or even a limited group of health care providers, normally does not indicate general acceptance by the medical community. Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with financial interest in the outcome, are not sufficient evidence of general acceptance by the medical community. The broad range of available evidence must be considered and its quality shall be evaluated before a conclusion is reached.

LCDs which challenge the standard of practice in a community and specify that an item or service is never reasonable and necessary shall be based on sufficient evidence to convincingly refute evidence presented in support of coverage. Less stringent evidence is needed when allowing for individual consideration.

It is my opinion that CMS has filed to follow the standards of excellence expected in making the proposed decision on the PILD procedure. I am disappointed that an agency in which sets the precedence for coverage and care, that are sought out by other insurance companies in the treatment and care of patients would fall short of expectations. I further call on CMS to review and reverse its non-coverage proposal in an effort to repair the damage done by this panel.

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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 treatment of spinal stenosis with neurogenic claudication…particularly for patients that are high risk surgical candidates or prefer an outpatient procedure to a much more invasive open procedure. This is therapy is not perfect for everyone with stenosis, but does work well in a carefully selected population.

As a physician who cares for a large number of seniors, I review the available evidence, try synthesize this with my clinical experience and try to come up with the most appropriate strategy for each and every patient who I care for. I try to give each patient the mother test, or what would I do for my own mother in this situation. I can unequivocally say that based on the literature on efficacy, and particularly safety and the rapidity that one can return to a relatively normal functional status, when I compare an open laminectomy or possible fusion compared to a MILD procedure, I would definitely offer the MILD procedure for the right patient.

I find it troublesome that CMS would demand nothing less than a blinded, randomized, controlled long term study before extending coverage; particularly when it already covers many procedures that do not meet this standard of evidence. Moreover the predicate therapy of an open surgical approach clearly caries a higher risk than the MILD procedure. The standard of a blinded, randomized, control study has not been held to open surgical approaches. Moreover there are ethical and other problems when one requires this standard for an invasive approach. Open surgery as a control introduces the problem that the two procedures are performed by different specialties (interventional pain physician vs. surgeon) and patient enrollment would not be possible (i.e. if a patient is truly a viable candidate for both, few would agree to be randomized into a study with such significant differences in safety profiles). “No Treatment” or a “sham” also has problems in pain studies since it is difficult to imagine that patients would enroll in a study where they could be assigned to a cohort that received no pain treatment for extended periods of time. Putting these issues aside, though, I feel that the biggest opportunity of PILD hasn’t even been addressed by the NCA; namely the potential savings to the health care system that this procedure offers.

If one were to do a conservative comparison of a decompression laminectomy costs to mild, one could easily see this. Let’s assume that the direct procedure cost for a mild procedure is $4,527 ($974 professional fee based on 63030 (the most similar procedure) and $3,553 average facility fee based on APC 0208). A total mild procedure treatment cost can be computed by taking the mean published responder rate of 75% as a reoperation rate proxy, an initial mild procedure cost of $4,527, a revision (decompressive laminectomy) cost range of $9,649 to $14,221 (1 - 3) and the formula: COST_total = COST_initial + [(COST_revision) x (1 – Responder Rate)]. This yields a cost range for the mild procedure of $6,939 - $8,082. This assumes that all mild non-responders go on to get a laminectomy, which is a very conservative assumption since not all non-responders necessarily go on to get surgery. This cost would even be less in the ASC setting where the facility reimbursement is less than 60% the facility reimbursement used for this calculation.

Modhia et al found the reported reoperation rate for patients treated with decompressive laminectomy was 6 – 7.9% (4). A total open direct surgery treatment cost range of $11,178 - $16,382 can be computed using a mean reoperation rate of 7%, an initial decompression procedure cost range of $9,649 to $14,221, a revision (fusion) cost range of $21,839 - $30,872 and the formula: COSTtotal = COSTinitial + [(COSTrevision) x (Reoperation Rate)] The resulting cost impact of the mild procedure is 42 – 73% of a standard decompression laminectomy.

There are some that might dispute these numbers but it is important to realize that the comparison is based only on the procedure cost itself and not to any related charges such as diagnostic imaging, medications, medical supplies, physician visits, physical therapy or other rehabilitation costs that can otherwise be found for a decompression laminectomy. Inclusion of these costs for the decompression laminectomy procedure adds at least 50% to the direct surgery costs and results in a cost range of $14,593 - $23,652 (2, 3), the high end of which is similar to the $26,201 cost reported by Deyo et al (adjusted to 2012 US dollars) (5). The impact on the mild procedure cost from inclusion of these additional charges is currently unknown, but with a shorter procedure time (60 min v. 129 min), shorter hospital stay (< 24 hours outpatient v. 2.7 days mean inpatient) (5, 6, 7), fewer transfusions (0% v. 9.5%) and fewer dural tears (0% v. 9%) (8, 9), any additional charges for the mild procedure can be expected to be less than for a decompression laminectomy.

Based on Medicare reimbursement for direct procedure and surgery charges, the cost of the mild procedure is less than half that of standard decompression laminectomy. This cost advantage is in addition to an improved safety profile and similar patient outcomes and responder rates when compared to standard decompression laminectomy. Inclusion of other costs directly associated with the procedures will likely improve the relative cost advantage for the mild procedure. As such, it is in CMS’s best interest to have a procedure like mild to treat LSS with neurogenic claudication.

As a society we need to search for lower cost therapies that provide equal or superior efficacy and improved safety over the predicate therapy. The MILD procedure is exactly the type of procedure we need to embrace as a society to improve pain control, safety and cost efficacy. Denying our seniors this therapy is likely to INCREASE the costs to society while relegating this select population to a much more invasive approach with no evidence of improved outcome over this relatively safe approach.

References:

1. Burnett MG, Stein SC, Bartels RH. Cost-effectiveness of current treatment strategies for lumbar spinal stenosis: nonsurgical care, laminectomy, and X-STOP. J Neurosurg Spine 2010; 13:39-46.

2. Parker SL, Adogwa O, Davis BJ, Fulchiero E, Aaronson O, Cheng J, Devin CJ, McGirt MJ. Cost-utility analysis of minimally invasive versus open multilevel hemilaminectomy for lumbar stenosis. J Spinal Disord Tech 2013; 26:42-47.

3. Tosteson AN, Lurie JD, Tosteson TD, Skinner JS, Herkowitz H, Albert T, Boden SD, Bridwell K, Longley M, Andersson GB, Blood EA, Grove MR, Weinstein JN. Surgical treatment of spinal stenosis with and without degenerative spondylolisthesis: cost-effectiveness after 2 years. Ann Intern Med 2008; 149:845-853.

4. Modhia U, Takemoto S, Braid-Forbes MJ, Weber M, Berven SH. Readmission rates after decompression surgery in patients with lumbar spinal stenosis among Medicare beneficiaries. Spine (Phila Pa 1976) 2013; 38:591-596.

5. Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA 2010; 303:1259-1265.

6. Mekhail N, Vallejo R, Coleman MH, Benyamin RM. Long-term results of percutaneous lumbar decompression mild(®) for spinal stenosis. Pain Pract 2012; 12:184-193.

7. Schomer DF, Solsberg D, Wong W, Chopko BW. mild(®) Lumbar Decompression for the Treatment of Lumbar Spinal Stenosis. Neuroradiol J 2011; 24:620-626.

8. Chen H, Kelling J. Mild procedure for lumbar decompression: a review. Pain Pract 2013; 13:146-153.

9. Weinstein JN, Tosteson TD, Lurie JD, Tosteson A, Blood E, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H. Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research Trial. Spine (Phila Pa 1976) 2010; 35:1329-1338.

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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 claudication. Combining patients’ symptoms with MRI findings of central canal stenosis due to ligamentum flavum hypertrophy directs me, as a clinician to the PILD (aka MILD) procedure. This minimally invasive procedure allows me to mechanically “debulk” the central spinal canal without the need for a large incision, without the need for adding instrumentation, without the need for hospitalization, and without the risks of an open spinal procedure.

As a neurologist, I am concerned with mitigating risk. With the reported complication of dural puncture (treated the next day with epidural blood patch), the PILD is certainly less traumatic and carries a much safer risk profile than open surgery. In my experience, I have had zero complications in 20 cases over the past four months. This parallels the reported statistics: in a safety meta-analysis of 373 patients that were treated with percutaneous lumbar decompression (mild), there were no major device or procedure-related adverse events reported and there were no mortalities.¹

Weighing the proposed benefits as seen in the studies, the PILD certainly ‘makes sense.’ In my experience of over 20 cases in 4 months, 18 out of 20 patients have reported significant improvement in their quality of life. One was a treatment failure as he achieved no meaningful improvement, and one is still premature.

I have not had 18 out of 20 patients, who had open decompression and fusion, have similar results in a short time frame. The recovery time has been up to 12 months, and requires extensive rehabilitation. This is not the same with the PILD.

When weighing the possible risks and potential benefits of PILD, the procedure is clearly a procedure worth performing.

When we have patients who are not surgical candidates secondary to comorbidities preventing them from general anesthesia, but suffer from neurogenic claudication with ligamentum flavum hypertrophy, PILD is the only option available to provide them with a meaningful quality of life.

As a board certified physician I strongly suggest a positive National Coverage Determination for PILD so that patients who suffer with spinal stenosis may have a safe, effective, and minimally invasive treatment option, and has the potential to provide benefit to a otherwise disabled population of patients.

1 Levy, Robert, et al. (2012), Systematic Safety Review and Meta-Analysis of Procedural Experience Using Percutaneous Access to Treat Symptomatic Lumbar Spinal Stenosis. Pain Medicine, 13(12): 1554-1561. doi: 10.1111/j.1526-4637.2012.01504.x

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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, significantly reduced or eliminated need for analgesic medication or epidural injections.

I was hoping to be able to provide this option to the large amount of patients I see with this condition. I don’t think there is a lack of consensus on diagnostic criteria for LSS, otherwise no other treatment would be indicated for this purpose. There are many conditions that lead to back pain, this is true, and our role as clinicians is to utilize the available history, diagnostic tests and physical examination to define spinal stenosis patients. Laminectomies and nonsurgical treatment options already exist to treat the condition but both with its own limitations and complications, the more therapeutic options we available the more likely it is that we are going to find the correct one for each individual patient. There are still questions about adverse events related to the procedure as with any other surgical procedure but, to my knowledge, no significant adverse effects have been reported in the published series. The placebo effect is not a significant risk but a confounding factor that can be considered when analyzing the data statistically , and this does not only apply to Interventional pain procedures but to any therapy. There needs to be a plausible mechanism of action to deem a treatment as efficacious, yes! and this one is clear particularly for the MILD. Change from preoperative radiographic evaluation should correlate with outcomes after decompression, this is true and this fails to result in up to 70% of surgical (open) laminectomies, this is know as “post-laminectomy syndrome” and is well documented in the scientific literature .

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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 for spinal stenosis and have seen the debilitating and expensive consequences of these surgeries.

This proposal is myopic. If a similar rationale was applied to Cardiovascular disease, Interventional Cardiology would not exist as it does today and patients would continue to be subject to the considerable morbidity and mortality of open surgical procedures. Interventional Pain medicine is at a similar crossroads and this proposal will discourage further innovation and advances in this nascent field.

In clinical medicine, we are taught to weigh the risks and benefits of any intervention. I suggest that CMS should operate in a similar fashion and reconsider this proposal and allow this modality for their constituents.

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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 common for treating pain physicians. Among this Medicare population lies the forgotten patient that have exhausted all conservative options, yet have no surgical options due to surgery-related morbidity and mortality. These patients are often referred by Orthopedic and Neurosurgeon’s to pain Physician’s in an effort to gain some form of relief. This is why it is important to recognize that the mild procedure is a reasonable minimally invasive option to pursue for patients who have failed conservative measures prior to considering an open laminectomy. CMS has identified the lack of consensus of diagnostic and treatment measures for spinal stenosis. This statement shows a lack of understanding for the diagnostic process and treatment algorithm for spinal stenosis. Historically, the most common conservative measures such as NSAID treatment, physical therapy, and steroid injections fail to show long-term results. Because each patient is different in reporting their symptoms, it makes sense that treatment would vary. After all “No two men are alike”.

In an article written by Mekhail et al., “Functional and Patient-Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression” showed that the mild procedure demonstrated a significant functional improvement as well as decreased disability secondary to neurogenic claudication. This article ties into my point that as a physician, it is my duty to seek measures and focus care on the relief of patient pain, and the restoration of the patient quality of life in the treatment of spinal stenosis. As a treating Physician, I urge CMS to take into consideration the devastating impact on the Medicare population should this procedure not be made available.

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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 patients are also not candidate for lumbar decompression or fusion due to other medical problems, in this circumstances the MILD procedure offer a great alternative when indicated.

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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 expensive operation. There are many patients who do NOT want to have a laminectomy and the mild fits in nicely after injection therapy no longer works. I believe the studies supporting the mild are numerous, extensive and more importantly show an improvent in functional status and quality of life measures for these unfortunate patients. It is safe and it is effective in our experience. Please don't help propagate the over-prescribing of opiates in an elderly population. Leave PILD as a tool to help us help our patients. Thanks.

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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 professional medical association for physicians practicing the specialty of Pain Medicine in the United States. On May 2, 2013, on behalf of AAPM, Dr. Webster submitted a letter summarizing the published clinical evidence and strongly supporting broad Medicare coverage for PILD for Lumbar Spinal Stenosis (LSS).

We were disappointed to see that subsequently in its proposed decision memo of October 17, 2013, CMS concluded “that PILD for LSS is not reasonable and necessary… [and] that PILD for LSS is non-covered by Medicare.” The draft prepared by CMS setting forth the proposed rationale for this decision was thorough but in its totality, raises barriers to innovative procedural therapies in general, not only the PILD procedure. Because some of these barriers indicate what may be seen by clinicians as well as the elderly and their advocates as an overly restrictive application of evidence-based methodology, we feel it imperative to comment upon this draft. Our goal is to initiate broader-based dialog concerning CMS’s approach to coverage for procedures whose evaluation may better be accomplished by effectiveness research rather than the efficacy model relied upon by CMS, as described in Appendix A of that draft. The comments below address points made in this draft decision that, if applied to other procedures, would have a dampening effect upon innovation in general. They include an observation on the limits of the efficacy-driven approach set forth in Appendix A of that draft, and conclude by emphasizing the importance of developing safe therapies for conditions predominantly affecting the elderly.

First, CMS identifies “lack of consensus on diagnostic criteria” for LSS as a negative factor in accepting the evidence accumulated to date. The same point may be made for many conditions in pain medicine, starting with the definition of “pain.” Yet, as the draft decision itself points out, “Based on the totality of the evidence reviewed a few common attributes are agreed upon. When we think of LSS we think of some type of connective tissue structural impingement. Accepted qualitative criteria for the diagnosis of lumbar spinal stenosis are the presence of disk protrusion, lack of perineural intraforaminal fat, presence of hypertrophic facet joint degeneration, absence of fluid around the cauda equina, and hypertrophy of the ligamentum flavum.” Therefore instead of focusing upon slight differences in the definition of LSS across clinical reports, it would appear more constructive for CMS to prepare an operational consensus definition based upon agreed-upon criteria and then indicate for each study which of these criteria are explicitly met.

Second, CMS identifies a lack of consensus on the treatment of LSS and goes on to state that “Because there is no consensus diagnostic definition for LSS, there is a corresponding lack of consensus on treatment.” In addition to being a non sequitur, this statement overlooks the fact, well-documented elsewhere in the draft, that open surgery is currently employed widely in the (generally elderly) population with refractory LSS. Common sense would dictate that a minimally invasive procedure with substantial evidence for its safety would benefit patients with LSS when open surgery, with its attendant risks and instances of failure, is the alternative.

Third, the draft document states that “recognition of a plausible mechanism of action is necessary if a treatment is to be deemed efficacious. Uncertainty leads to reasonable doubt that a witnessed event is causally related to any specific intervention. For invasive treatments there is generally a well-defined structural target. One does not operate on pain per se, but on the pain generator.” However, the document itself proceeds, “The stated goal of PILD is to reduce the thickness of the ligamentum flavum and thereby reduce the connective tissue impingement that is believed to cause the pain. The procedure relies upon removing various types and amounts of connective tissue to conform to a radiographic picture of intraoperative fluoroscopy (with epidural contrast) to reduce the functional stenosis.”

Fourth, in its “Analysis of evidence for PILD as a treatment” the draft proposal acknowledges that case series may indeed have merit, but ignores the growing importance placed upon assessment of real-world, comparative effectiveness through procedures such as patient registries and data mining. Complex conditions are common throughout medical practice, including pain medicine where several potential pain generators often co-exist in the elderly. It is therefore likely that large numbers of patients will need to be assessed in order to analyze which subgroups are likely to respond to procedures. Doing so will take considerable time and effort, and will be precluded if the resources required to accumulate such data exceed the capacity of any sponsor interested to so advance the state of medical practice.

Lastly, we believe that it is insufficient to state under “B. Disparities” that “the current PILD literature does not address disparities, with the exception that gender is reported in some studies.” LSS is a condition of middle-aged and older persons. A large literature documents that pain complaints are often taken less seriously, and dealt with less aggressively, in older persons than in younger persons. It is hard not to view the high – essentially insurmountable – hurdles set forth in the proposed draft as evidence of indifference to the urgent, unmet need for innovative, safer therapies than those currently available for the elderly – a rapidly growing segment of our population.

AAPM would be delighted to discuss the above at greater length. In an editorial in AAPM’s journal, Pain Medicine, the distinguished pain physician Professor Michel Dubois provided a balanced appraisal of the limited evidence to date regarding the PILD procedure [Pain Medicine 2012; 13: 1529-30]. He concluded: “A new, minimally invasive treatment modality with minimal risk is badly needed for the treatment of lumbar spinal stenosis, an increasingly prevalent condition due to our aging population and one for which we have very little to offer, except surgery with its limitations.” The above points have implications not only for the PILD procedure, but for others in which a placebo control may not be practical or ethical. We have conveyed them in very concise fashion because of the format of the comments allowed upon the proposed draft memo, as well as the short time window to provide them.

Sincerely,

Lynn R. Webster, MD
President

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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 patient.

To this end, I believe that CMS should consider the large and growing elderly population who are either unwilling or unable to tolerate general anesthesia and the potential adverse effects associated with open decompression procedures. It is necessary to introduce less-invasive therapy options that treat the underlying cause of the condition to provide long term relief. Conservative medical management is not a long term treatment option for this subset of lumbar spinal stenosis patients that have neurogenic claudication. To suggest that medical management is a treatment option for these patients will only contribute to the prescription drug abuse problem in America.

The MILD procedure offers this subset of patients, those with lumbar spinal stenosis with neurogenic claudication, a viable treatment option that can improve their quality of life. Patients with neurogenic claudication are easy to diagnose- their ability to walk or even stand upright is severely limited by the pain and discomfort in the lower back, legs or buttocks during activity. This pain and discomfort is relieved with flexion, when they bend forward or sit down. An MRI can confirm the clinical symptoms to show the level and severity of the stenosis. This same diagnostic process, including clinical symptoms and MRI confirmation, is how surgeons are diagnosing lumbar spinal stenosis and performing laminotomies, laminectomies and fusion. This begs the question: why would the MILD procedure need to have a more strict diagnosis requirement than the already covered and broadly used CMS surgical procedures that treat the same condition? To quote the SPORT study, “all patients had neurogenic claudication and/or radicular leg symptoms; confirmatory cross-sectional imaging showing lumbar spinal stenosis at one or more levels; and were judged to be surgical candidates.” (New Engl J Med, 2008)

Rarely do elderly patients present with hypertrophic ligamentum flavum only. This is a degenerative condition, so the stenosis can also be caused by disc bulge, osteophyte formation, etc. which also impinge upon the canal. If the hypertrophic ligamentum flavum is a predominant factor of the stenosis then MILD can help these patients. In the article on Cleveland Clinic study, it stated “review of these patient MRIs usually reveals that the cause of symptomatic lumbar spinal stenosis is multifactorial in nature. Disk bulge, facet hypertrophy, and invariably, ligamentum flavum (LF) hypertrophy, which compromises the central canal, are commonly found. Clearly, it is not necessary to correct every causal factor in a large population of spinal stenosis patients. It has been reported that the majority of spinal stenosis patients have hypertrophy of the LF and that its thickness may account for 85% of lumbar spinal canal narrowing.” (Pain Practice, 2012)

I believe that the MILD procedure has proven that we can treat one causal factor of lumbar spinal stenosis with a minimally invasive approach that is safe and effective. By treating the underlying cause of the condition we can provide improved quality of life for a large and growing elderly population that do not consider open decompression procedures as viable treatment option. For these patients who feel they have no options, I strongly suggest a positive National Coverage Determination for PILD,or MILD.

Respectfully,

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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 comments made by physicians who actually treat patients with spinal stenosis, I would like to address some concerns posed in the draft policy.

According to CMS, there are questions about adverse events related to the procedure. I find this to be an extremely perplexing concern given the vast amount of evidence that has been presented on this therapy over the last three years. The NCA cites a paper by Dr. Chopko as support for this concern but the publication itself indicated that the complications were most likely related to the general health of the patient and not the procedure itself. I see that this is actually confirmed by Dr. Chopko himself in the November 5 comment he posted to this NCA. The second source cited was the Tumialan Letter to the Editor. Several things are important to note with this. First, “refractory neurogenic claudication” should be considered a response failure and not an adverse event. This leaves the two alleged cases. In my response to the Tumialan letter (which the NCA did not reference), I clearly stated that “Regarding the author’s view on safety, given the clear procedural instructions, safe instrument design, and creation of an epidurogram safety barrier for performing the percutaneous procedure, the number of postprocedural issues mentioned is surprising. To suggest that a procedure as inherently safe as mild is ‘‘as susceptible to complications as simple decompression or fusion surgery’’ simply makes no sense to us. As is the case at Cleveland Clinic, the incidence of serious side effects noted by Dr. Tumialan is unheard of at centers currently providing percutaneous decompression treatment on a routine basis. It would be of interest to know the specifics of the two alleged adverse events to attempt reconciliation with the positive safety data reported in all clinical studies to date.” To date, I have not seen any additional information on these incidents. This, then, leaves us with the peer publication record of a couple of dozen articles that all show an extremely low rate of adverse events. A safety review and meta-analysis of PILD was published in Pain Medicine 2012 which reported “of the 373 patients included in this safety review, there were no reports of major device- or procedure-related adverse events, and there were no mortalities. Major complications were defined as any device- or procedure-related event that required intervention, including events such as incidental durotomy, epidural hematoma, infection, or bleeding that required transfusion.” No procedure has zero risk of adverse events, which is why a perfect safety record can be subject to scrutiny but the safety of PILD (mild) is ensured by the design of the instruments and the design of the procedural approach. The use of an epidurogram provides continuous visualization before during and after the decompression with the epidural contrast layer providing a visual barrier that the devices do not cross during the procedure. The devices are only used posterior to the epidural space and have blunt tips, which also greatly minimize the risk of an adverse event during the procedure. Interestingly, among the very few comments made in support of your non-coverage policy, not even the neurosurgical organizations are challenging the safety profile of this procedure.

Regarding the efficacy of procedure: I have noticed that a large number of my colleagues have posted comments supporting the strength of the efficacy data and the significant role this therapy plays in the treatment of lumbar spinal stenosis with neurogenic claudication for the large number of patients who have no other viable options. These comments are made by physicians from major academic centers and also private practitioners. I would like to voice my support for these positions. Some have suggested that we should perform an RCT against surgery but I would refer you to my Letter to the Editor in Response to Dr. Tumialan where I stated “The suggestion that mild be compared to any decompression procedure that requires general anesthesia, larger incision, longer recovery, and based on current literature, has an increased risk of adverse events, is likely not going to bode well with most IRBs. Also, for informed patients considering surgery to relieve neurogenic claudication, once presented with these facts, it is questionable whether such a study could even be enrolled at any research facility.” It is striking to me that CMS would have such a high standard of evidence compared to already approved therapies when mild has such a favorable safety profile, uses very few health care resources, fills an LSS treatment gap, and has such a large amount of data across multiple studies. I urge CMS to consider the benefit this procedure provides to CMS in terms of reduced health care dollars and to its beneficiaries in terms of a procedure that is safe and can dramatically improve the quality of their lives. I respectfully recommend that you reverse your decision and issue a favorable national coverage determination.

Chopko, B., (2013), Long-term results of percutaneous lumbar decompression for LSS: Two-year outcomes. Clinical Journal of Pain. doi: 10.1097/AJP.0b013e31827fb803 [Epub ahead of print].

Tumialan L. Regarding: Long-Term Results of Percutaneous Lumbar Decompression MILD for Spinal Stenosis. Pain Practice 2012; Volume 12, Issue 3: 252–253.

Benyamin R. Regarding: Dr. Tumialan et al. In Response to Long-Term Results of Percutaneous Lumbar Decompression MILD for Spinal Stenosis.

Levy, R., et al. (2012), Systematic safety review and meta-analysis of procedural experience using percutaneous access to treat symptomatic lumbar spinal stenosis. Pain Medicine. 13(12), 1554-1561. doi: 10.1111/j.1526-4637.2012.01504.x

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

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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 can tell you that this procedure has been a positive difference maker in peoples lives. Compared to surgery and narcotic pain medication, it is significantly more effective and safer. Most people who are good candidates for this procedure are poor candidates for surgery and narcotic treatment. What then is left to offer these suffering patients? Take this procedure away and there will be nothing but a withering miserable life. In my opinion, before you offer major spine surgery and its associated risks of hemmorhage, infection and intraoperative complications to patients, they should be required to undergo the percutaneous procedure first. Can you imagine how you might feel undergoing major surgery yourself, only to find out later that there was a minimally invasive procedure that is just as, if not more effective than surgery, takes about an hour to do as an outpatient and has very few risks? If you had any complications or unsuccessful surgery, I believe you would be very upset. Why would you agree to pay for spine surgery when the costs are 10x what a mild procedure is and studies have shown that the minimally invasive procedure is just as, if not more effective. Multiple studies have proven that statement. Please give every consideration to allow this procedure to remain available to patients

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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 stenosis which challenges the persuasiveness of the available evidence that might otherwise support the MILD procedures efficacy. "Neurogenic claudication due to LSS is a connom problem that can be due to hypertrophic ligamentum flavum, facet hypertrophy, disc and osteophyte herniation, malalignment, or a combination of these factors." (CHOPKO2011) This article reported an initial experience in the application of the mild procedure as a new technology. The article states the mild procedure had potential as an additional option beyond failed conservative measures. Each patient identified for this study were deemed to be at too great a risk for complications due to co-morbidities. It is important to note that these complications were not related to the mild procedure or device.

CMS also noted a reported statistically significant VAS change, but no change in ODI. VAS measures the amount of back/leg pain a patient feels on an 11 point scale (0-10), whereas the ODI measures permanent functional disability with a series of questions on activities of daily living. Patients reporting back/leg pain reported a statically significant improvement at the post-operative follow up. The lack of ODI scores can be attributed to the fact that many of these patients had physiologically limiting coexistent issues, such as oxygen-dependent pulmonary fibrosis, prior stroke and systemic malignancies.

The mild procedure addresses the vulnerable hypertrophic ligament flava that becomes inflamed as we age and begins to ossify. Neurogenic claudication is accompanied by pain in the back, buttocks, and legs that is relieved by stooping, caused by mechanical disturbances due to posture or by ischemia of the cauda equina. As we continue to age, the anatomical components of the spine becomes vulnerable to degenerative conditions that can lead to painful spinal nerve compression. I would like to point out the clinical data available regarding the mild procedure documents a clear alternative to a growing need among our elderly population. The aging population in our country has been called our fastest growing community. Chronic low back pain (CLBP) is one of the most disabling and therapeutically challenging pain conditions afflicting the elderly. The mild procedure provides a lower cost alternative coupled with a significantly shorter facility stay, and it makes sense to offer this minimally invasive option to patients who have been designated appropriate for this procedure. I encourage CMS to consider not only the aforementioned data but the unspoken effect on an elderly patient population that would otherwise suffer the consequences of this decision.

1. Chopko B. A novel method for treatment of lumbar spinal stenosis in high-risk surgical candidates: pilot study experience with percutaneous remodeling of ligamentum flavum and lamina. J Neurosurg Spine 2011;14:46–50.

The MILD procedure offers a minimally invacive procedure treatment option which is economical, and offers minimalmorbidity and rapid recovery to complete recovery if function and activity level. I offer this treatment only to appropriate patients who would otherwise not have an option for relief of their neurogenic claudication symptoms.

The MILD offers a continium of care for patients suffering neurogenic claudication from spinal stenosis. It is an ideal treatment option to the patient who initially responded to lumbar epidural steroid treatment, and now fails to get long lasting relief form epidural injection therapy, and is not a surgical candidate due to their under lying medical condition. This is an ideal procedure, as well, for the patient who chooses not to have surgery due to the cost, prolonged recovery, or risk of the open surgical procedure, and provides a safe and economical alternative to open lumbar surgery in the patient wiht neurogenic claudication from spinal stenosis.

This is a letter a patient of mine wrote to appeal the denial of the MILD procedure to his insurance carrier. It was approved and patient did have the MILD procedure performed. He was recently seen in followup 6 weeks after his MILD procedure. He reported no pain postoperatively from the procedure, or his preoperative leg pain. Within two weeks of the procedure he was hiking 2 hours on uneven ground without pain in his low back or legs. Prior to the MILD procedure this patient could not stand greater than 3 to 5 minutes, or ambulate 50 yards without severe pain which required him to sit for 5 minutes to get relief. This is a treatment option that must be available to treat this patient population.

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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’ coverage decision.

I have performed the PILD procedure on 150 patients. Of these patients, I have referred 9 patients for surgical decompression. The remaining patients have had a success rate of either 100% pain relief or pain relief to the extent that only further conservative treatment was needed which had failed them in the past.

My treatment criteria for PILD patients consist of patients with mild encroachment on the spinal canal, a level of encroachment in which most surgeons do not consider surgical intervention as option. Although there seems to be quite a bit of controversy over specific diagnostic criteria for spinal stenosis, I can say with certainty that my patient outcomes have been as a result of proper patient selection.

The PILD procedure is a critical step in the treatment of spinal stenosis. Removing this critical component further exacerbates Physician’s ability to properly treat patients. Once again, I urge CMS to reconsider it decision.

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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 following the procedure. Many of these patients were diagnosed by my neurosurgical colleagues to have neurogenic claudication, but were felt to be unfit for more invasive surgery due to comorbidities. This is certainly a void that needs to be filled, and one that the 'mild' procedure does nicely. 'Mild' provides a minimally invasive alternative, that is sufficient in select patients to relieve their neurogenic claudication symptoms so that they can return to more normal activities.

I can appreciate that more concrete diagnostic criteria would help with patient selection, but again, many more invasive surgical procedures such as laminectomy/fusions have similar criteria, with much greater risk as well as cost. One of the strengths of this procedure is that it does not interfere with future intervention if it were to not be successful or sufficient in relief of the patients issues. On a daily basis, my schedule is scattered with patients who have had multiple lumbar surgeries to treat various spinal disorders, and I have yet to see one that would warrant the diagnosis of "post minimally invasive lumbar decompression syndrome".

With regard to the effectiveness of the procedure, again I will agree that the studies may not be perfect, but this is inherent in any study evaluating pain interventions due to the lack of a possible sham treatment, as well as the difficulty quantifying pain. With 'mild', the practitioner is at least able to gain visible evidence of increased contrast flow during the procedure at the symptomatic levels.

Minimally invasive lumbar decompression provides a safe, cost effective, and truly life changing treatment alternative for a debilitating condition. If CMS is not in the business of facilitating these things, I'm unsure as to what their goals are.

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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 the country. It is also very cost effective and safe. It should be approved procedure for medicare beneficiary.

Thanks

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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 want to have the MILD procedure done on myself before an open surgical decompression laminectomy. My surgical partners also see the value of the MILD procedure and are routinely referring for the procedure in patients that are poor candidates for general anesthesia. I am having trouble understanding why CMS is having such a hard time defining spinal stenosis. This has always been a diagnosis made based on history, physical examination, and MRI. Patient's with symptomatic central spinal have clear symptoms of neurogenic claudication which when correlated to an MRI showing severe stenosis makes the diagnosis. This is the way the diagnosis has been made since the advent of the MRI and this is the way surgeons currently make the diagnosis when deciding to offer an operation for a patient. With the MILD procedure patients finally had an option between the extremes of doing nothing (continuing to suffer the extreme mobility limitation of spinal stenosis) and taking the inherent risks of an open operation. To state that the MILD procedure does not add to the available options in the treatment of spinal stenosis is to equate cardiac catheterisation with CABG surgery. How many people will suffer with prolonged surgeries and recoveries with this decision? How many people will need mobility devises as a result of this decision? I can assure you as a conscientious physician who cares about outcomes for his patients this decision is the wrong one and patient's will needlessly suffer as a consequence. I hope that CMS reconsiders this decision for the benefit of an aging population who desperately needs some other option besides a major operation for the treatment of spinal stenosis. Thank you for taking the time to review my comment.

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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 trained to perform the PILD procedure, known as MILD, in 2009 and in the last 4 years have personally treated over 100 patients with the MILD procedure. I disagree with points made in the proposed decision memo and request coverage of this procedure.

The durability of the MILD procedure is questioned in the draft memo and it states that there is uncertainty on the durable benefit, as well as, no persuasive evidence on the ultimate outcome of the mild procedure. In my practice, I have treated numerous patients that experienced significant pain reduction and improvement in mobility 1 week after the MILD procedure and are currently 2 years post-mild with sustained pain relief and mobility improvements. I realize that CMS may view my practice experience as anecdotal but they should not dispute the published peer-reviewed data that exists to support the durability of mild. The Clinical Journal of Pain published a long-term, 2-year prospective study of the mild procedure LSS where 45 patients experienced statistically significant mean decreases in pain (VAS improvement of 3.8 points) and improvements in functional mobility (ODI improvement of 11.6 points). The positive outcomes achieved with the minimally invasive mild lumbar decompression were found to be stable and maintained throughout the 2-year study period. No major device- or procedure-related adverse events were recorded during the procedure or study term.¹

There is an obvious gap in the treatment algorithm that can be filled with the mild procedure. Nonsurgical treatments can include physical therapy, back brace, bed rest, walking aids, ESI, chiropractic, acupuncture, and the use of anti-inflammatory drugs and opioid analgesics. All of these have short term pain management benefits for patients with symptomatic neurogenic claudication but none of these treatments have been proven to provide sustained decrease in pain or improved function.

The memo also states that laminectomies and nonsurgical treatment options already exist to treat lumbar spinal stenosis. This statement is true. These treatments do exist. These treatments also have a proven failure rate of over 20% at 2 years & a significant complication rate of over 18% including significant bleeding requiring transfusion, permanent nerve injury, unresolved pain & of MOST significance NO long term data to prove improved function. MILD has been demonstrated to be efficacious in improving function as demonstrated by improvement in ODI & reducing pain long term at 2 years & in my practice nearly 4 years. NO presently available surgical option has been scientifically proven so.

The treatment algorithm suggested by CMS indicates that patients who fail conservative therapy should then be offered an open surgical decompression where they must undergo general anesthesia, face major risks of complications such as dural tear, blood loss requiring transfusion and death, and potentially face 1 year of recovery to resume normal activity.² It cannot be denied that a safe, efficacious and minimally invasive option must be added to the treatment algorithm.

MILD is the treatment option to fill this gap and has the data to prove its efficacy as demonstrated in many publications and recently in the systematic safety review and meta-analysis conducted by Levy, et al. and published in Pain Medicine. In this meta-analysis efficacy data on 134 patients treated with MILD at a year showed a responder rate of 81%, a VAS improvement of 3.9 points, and a 16 point improvement on the ODI scale.³

The MILD procedure provides LSS patients with a safe, efficacious, cost effective and durable solution to fill the gap between current palliative nonsurgical solutions and invasive open surgical treatments. I believe that it is absolutely reasonable and necessary for Medicare beneficiaries. Please consider a favorable National Coverage Determination for this procedure. The is NO reasonable clinical reason to expose elderly Medicare beneficiaries to significant risk of surgery when a safe effective treatment option is now available for treatment of LSS. An additionally, just as with other treatment options, if MILD fails to relieve the pain & restore function, the patient always has the option of considering open laminectomy & its associated risk.

There is an epidemic of OVER utilization of surgical laminectomy as a treatment option in this country with the significant negative outcome of increasing numbers of PERMANENTLY disabled citizens that cost us all. You have the opportunity to significantly decrease cost of care for many LSS patients, improve safety & the quality of life for millions of Medicare beneficiaries while decreasing patient risk factors. IF MILD were to become unavailable, these patients would be left to suffer in pain with exposure to all the other associated comorbidity of inactivity i.e. falls(hip fractures, DVT, decubiti, worsening osteoporosis) or consider laminectomy with its poor long term outcomes for LSS & associated risk.

MILD should be available as a treatment option for those that fail conservative treatment prior to considering open laminectomy for Medicare beneficiaries. I have over 100 patients in my practice that thank me for offering them a better choice.

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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 little efficacy with very high complication rates (SPORT Trial).

The cause of neurogenic claudication is multifactorial. It begins with disc degeneration and follows with significant associated joint dysfunction and hypertrophy. This leads to significant narrowing of the central canal from ligament impingement. The hypertrophy of the ligament is but one aspect of this debilitating disease. It affects a vast swath of our population, and a very large degree of those patients are Medicare beneficiaries. Previous to this innovative technique, all that was available to patients were epidural steroid injections, which work well for nerve root irritation, but not central stenosis, and offering patients dubious open back surgeries that lead to significant complications including death, or committing them to dangerous narcotic medications with equally little evidence of long term benefit.
PILD was not associated with a single death or hospitalization in over 12,000 performed procedures.

My personal experience involves more than 250 of these procedures. At least 70% of my patients received at least a 50% improvement lasting at least a year. Their quality of life was improved, they were able to rejoin activities of daily living, and more important were able to avoid a potentially life threatening surgery. These patients did not want open back surgery. In fact, AARP lists spinal stenosis surgery and laminectomy as one of four surgeries seniors should avoid.

PILD was never intended to be the end-all and be-all for spinal stenosis. Rather, it provides a palliative treatment that improves quality of life. My patients were extremely satisfied, and continue to be so. It is striking at the very core mission of Medicare by removing this efficacious treatment. By holding PILD up to a standard of proof of benefit that no other interventional spine procedure has ever been held to (and frankly could not muster) is nonsensical. Rather, if this methodological approach is being taken by CMS, then no interventional back surgical procedure that is invasive, including instrumentation and fusion should be considered medically necessary. This wrongheaded decision by CMS dooms our most vulnerable population to either no treatment or unproven, expensive, extremely invasive and life-threatening surgery, which leads invariably to blood transfusion, hospital readmission, and ultimate failure. All of which are exceedingly more expensive than offering PILD.

I urge CMS to strongly reconsider and reverse its initial decision on PILD. I will also share this concern directly with my patients and peers, through local, state, and national channels.

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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 define spinal stenosis patients.”
Though it is true that many conditions cause low back pain, the Pain Practitioner who performs PILD is an expert in identifying pain generators/causes and treating them as required. In fact, one of the criteria for pain physician board certification is the identification of spine pain generators and their appropriate management. The patient’s historical data, physical exam findings, and radiology evaluation serve as tools for determining a diagnosis. PILD does not treat nonspecific “back pain” but on the contrary, treats one very specific condition- lumbar spinal stenosis with neurogenic claudication. Patients with this condition are easily identified. Starting with symptoms, they experience worsening pain with duration of walking time and standing time. With concomitant MRI findings of narrowed spinal canal space (usually less than 10 mm in AP diameter) the symptoms strongly suggest neurogenic pain pathology as a consequence of a spinal canal restriction. Some spine pain syndromes may present with a component of the aforementioned clinical signs, but not all.

One of the confounding factors of diagnosing spinal canal stenosis is that it can, and often does, coexist with other spinal pathologies that cause pain. It is important for the practitioner to decipher which spine pathology is the predominant symptom generator. In the case of lumbar spinal canal stenosis, if the patient describes pain with walking and with standing as the most significant limitation of their quality of life it is reasonable to place spinal canal stenosis on the forefront of a differential diagnosis.

Point 2: “A lack of consensus on treatment of LSS & existence of other treatments: A lack of consensus on diagnostic criteria for LSS also means there is a lack of consensus on the treatment of lumbar spinal stenosis. That being said, laminectomies and nonsurgical treatment options already exist to treat the condition.”
This argument against PILD is a logical fallacy. The first sentence suggests that a lack of consensus on spinal canal stenosis means that this condition does not exist; however, the next statement claim that there are treatments for this pathology. Thus, if the condition does not exist then it cannot be true that treatments exist for this condition.

The assumption that PILD should not be an approved procedure because other treatments exist is not commensurate with basic philosophical and financial pillars of modern science. Fundamentally, clinical research is performed to create new strategies, or improve on old ones, to solve a medical problem; PILD is a novel procedure that has evidence based data which demonstrates resolve of a clinical condition with less morbidity and similar patient satisfaction compared to predecessor techniques. Research is also conducted to minimize the economic burden of medical treatments on society; PILD can be performed at a cost significantly lower than most conventional treatments and has received national praise for its ability to substantially reduce the cost of pain management.

Nonsurgical options do exist to treat pain from canal compromise; however, many of these treatments have not demonstrated good efficacy or produce risk to the patient that outweigh initiation or continuation of the medicine. Most oral medications are known to produce mental status changes in the elderly (ie: antiepileptics , opiates, and tricyclic antidepressants—all off label use). The risk of medication side effects are compounded in the elderly, mainly due to impaired drug metabolism and excretion. Considering that more than 95% of patients with spinal stenosis are over the age of 60 a non medicinal minimally invasive spinal stenosis treatment like PILD fills a necessary clinical gap

Point 3: “Durability of the mild procedure is questionable: There is uncertainty on the durable benefit and no persuasive evidence on the ultimate outcome of the mild procedure.”
There are several peer reviewed, investigator initiated trials which have demonstrated long term pain and functional benefit from PILD. Personally, I have performed over 30 cases, using functional status, refraction to physical therapy, oral medications, epidural injections, facet injections, pain intensity, and radiology as inclusion criteria for choosing my candidates.

I started PILD more than 2 years ago and have been following my patients since the inception date of PILD in my practice. More than 80% of the patients who I have performed this procedure on have reported marked improvement in walking and standing tolerance, mood, decrease in pain medicine dosing and frequency, and an overall improvement in her quality of life. Prior to performing PILD in my patients they required an average of 3 spinal injections per year. Afterward, on average, most patients have required less than one injection per year. In order to make this service available to more patients my PILD-treated patients are willing to testify on behalf of this procedure. They allow me to share their clinical histories with the governing bodies in charge of the appeal to overturn PILD as a minimally invasive alternative to surgery. This speaks to the power of the patient satisfaction levels as well as the demand for the procedure. The patients are experiencing an improvement in their quality of life and PILD is reducing the overall healthcare costs by avoiding major surgery and decreasing conservative therapies (ESI, PT, medications, etc.) post-procedure.

Point 4: “There are still questions about adverse events related to the procedure.”
There is a paucity of evidence in the clinical literature and the Maude database reporting supporting safety concerns. Of the approximate 500+ patients enrolled in the clinical studies, there have been no adverse outcomes; I have not had any in my practice. Early in 2013, the procedure was also approved to be performed in the ambulatory surgery center setting which further demonstrates its safety.

I am a Pain Medicine Program Director at one of the largest academic institutions in the country and have taught my resident physicians this procedure. I have allowed some residents to perform it with my direct supervision.

Point 5: “The placebo effect is a significant risk, particularly for interventional pain procedures: Interventional pain procedure studies must, therefore, have strong randomization, blinding, and controls before one can draw conclusions on efficacy.”
The placebo effect is ubiquitous in clinical practice and does not only affect Pain Practioners. Double blinded, randomized control trials can limit this effect, or at least, create parity among groups but cannot eliminate it. To that end, it is possible to perform randomized double blinded studies for medical treatments because of the ease of placebo administration and relatively limited ethical struggle with administering a pharmacologically inactive compound. On the other hand, placebos and blinding are nearly impossible with surgical interventions: placebo for intervention would entail risking a patient’s well being by exposing the patient to the potential pitfalls of surgery without providing a beneficial treatment. Clearly the risk to benefit profile weighs heavily in favor of medical placebo research. For this reason an IRB rarely allows initiation of placebo controlled studies.

Point 6: “There needs to be a plausible mechanism of action to deem a treatment as efficacious: CMS cannot be sure removing small segments of connective tissue makes a difference despite flurorscopy images. Change from preoperative radiographic evaluation should correlate with outcomes after decompression.”
Mechanisms of action do not need to be apparent to deem a treatment as efficacious. This comment is inaccurate, and does not reflect what is seen in spine surgery treatment today. Surgical microdiscectomy is performed nationwide and there is often minimal change in post operative radiography. In addition, these changes do not seem to correlate with patient improvement. Furthermore, hemilaminotomies and hemilaminectomies are performed regularly without any appreciable post radiographic spinal decompression with similar patient outcomes.

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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 open decompression, with no hospital stays and improtantly, no prolonged hospital stays that occur in 5-7 % of open decompression procedures.

Image guided decompression allows the oporator to judge the degree of decompression as the procedure progresses. When watching these images, one can see the marke dchange in stenosis from releasing some of the dorsal attachments of the yellow ligament. This is the 'plausable mechanism of action' that results in symptom relief.

Compared to open decompression, image guided decompression has dramatically fewer complications, multiple trials demonstrating efficacy and much lower cost. It does tread on the practice of neurosurgeons, and for that reason, the American SOciety of Neurological SUrgery has opposed it. That opposition is simular to the cardiac surgeons opposition to angioplasty in the 1990s. Ration evaluation of the data clearly demonstrates efficacy and safety of this therapy. CMS should serve to make decisions on the data, not the will of spine surgeons.

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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 percutaneous image-guided lumbar decompression for lumbar spinal stenosis (CAG-00433N). This proposed decision memo also includes the proprietary minimally invasive lumbar decompression mild procedure. The Mayo Clinic has experience with this new procedure and we respectfully ask that CMS reconsider coverage of the mild procedure for the reasons stated below.

Spinal stenosis is a common condition among our aging population. To date conservative treatment options have been limited and in many instances ineffective. As a result many patients require open surgical decompression to obtain relief. While open surgical decompression has been time tested it is far from a perfect treatment and has been shown to fail in 30-40% of patients (1). In addition, it requires general anesthesia, an open incision, hospitalization, and has known complications that can be severe in nature (1). In regards to mild some have questioned why the medical community and more importantly our patients need a new treatment option when we have a long-standing (open) procedure. We would address that question by drawing an analogy to the fields of cardiology and cardiac surgery. Not long ago the only option for a patient with occlusive coronary artery disease was open by-pass surgery with all of its known risks and complications. Thankfully, the options have progressed and newer much less invasive techniques (angioplasty, bare metal stents, and DES) have developed. These techniques were far from perfect when they were first introduced but with time have been refined greatly. As a result millions of patients have benefited from a much less invasive treatment to their clogged arteries. Of note, there are still many patients who undergo an open technique for a variety of reasons. In our opinion the mild procedure will likely follow the path of PCTA.

To date there have been over 12 peer-reviewed studies published representing over 400 unique patients (2-13). These studies have held up to the strictest of scientific rigor and have shown that the mild procedure is as effective as the traditional open procedure. Furthermore, a safety profile that far exceeds the open procedure has been demonstrated. An ongoing study is being conducted and its results will certainly shed more light on the topic. While these initial studies may not represent a large volume they are not insignificant and should not be ignored.

At the Mayo Clinic we have performed the mild procedure on more than 50 patients with over 100 treated stenotic areas. We have meticulously kept records that have included assessment of pain and symptom improvement (VAS, ODI, ZQC) with a hope to add to the medical literature on this topic. Our results have been very similar to the previously mentioned studies. Importantly, we have not experienced a single complication and no patients have required a hospital stay. We look forward to publishing results in the future.

Based on the already published studies and our experience here at Mayo we would propose the following selection criteria for the mild procedure.

• A patient with symptomatic neuroclaudication that interferes with activities of daily living.
• Pain that originates in the low back and radiates to the buttocks and legs.
• Is worse with walking and prolonged standing.
• Is relieved by sitting or assuming a flexed position such as leaning on a shopping cart or walker (this is classic for neurogenic claudication and helps to rule-out other etiologies such as facet disease or disk pain).
• No signs of vascular claudication.
• Unresponsive to conservative measures including medications, physical therapy and epidural steroid injections.
• MRI evidence of central canal stenosis at one or two lumbar levels with ligamentum flavum thickening > 4.0 mm (the original studies used >2.5 mm but this stricter criteria may tend to better outcomes and will decrease the chances of a patient getting this procedure if they are not a good candidate).

Furthermore, we feel it would be a mistake to reserve this procedure for patients too sick to undergo the traditional open surgery. By limiting the availability to the sickest population outcomes will be unfairly biased towards failure because the procedure will only be offered to patients that have been refused surgery. If this happens we may never know just how beneficial mild can be to our aging population. In addition, any potential cost savings this procedure offers could be lost.

In conclusion, we would like to propose a personal question to you. If you or a loved one suffered from severe spinal stenosis that greatly affected your ability to ambulate and was unresponsive to conservative treatments what treatment would you pursue? Would you go directly to an open surgery with general anesthesia, a hospitalization and its known complication rate or would you seriously consider the mild procedure as an outpatient with minimal sedation? Based on a review the cited studies and the experience of the Mayo Clinic we would certainly pursue the mild procedure.

Should you have any questions and wish to talk to me directly, I can be reached at the following 507-284-9696. Thank you for your consideration of this request.

Sincerely,

References

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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 Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N).

I am a Diplomate of the American Board of Anesthesiology with Fellowships (Research & Clinical) and Board Certification in Pain Medicine and have been performing the PILD procedure in a large medically-underserved county in the State of Delaware.

Before deciding to perform the procedure in my community, the evidence was reviewed by the local hospital multidisciplinary committee and concluded that would be safe to offer this procedure in selected patients with symptomatic lumbar spinal stenosis. We then performed the first series of PILD over 6 months. After reviewing the local outcome data with the local hospital committee again (we were able to replicate, at a small scale, the positive outcomes reported in the medical literature); we then decided to continue to offer this procedure to the community.

I am hereby expressing my disappointment with the CMS proposed decision of non-coverage for the PILD procedure.

Upon reviewing the decision, I came to question several points brought up by CMS as the key factors for non-coverage. CMS states the scope of this NCA includes a review of the evidence on whether percutaneous image-guided lumbar decompression for LSS provides improved health outcomes in Medicare beneficiaries. I would have to disagree with CMS identification or purpose as I as well as many of my colleagues agree that had this been simply a review of the evidence, the proposed decision would be in favor of coverage. I have spent a significant amount of my training and career mentoring residents in an effort to improve the field of interventional pain. This procedure inspired many physicians in training to pursue a career this medical discipline after observing the results in their interventional spine rotation. I firmly believe in the PILD procedure and find it disturbing that the overwhelming evidence as well as outstanding patient outcomes have been overlooked.

CMS states 'It appears consensus as to the definition of spinal stenosis has not yet been reached among experts. Indeed, I believe there is no “gold standard” for diagnosis and treatment of stenosis because of variability of signs and symptoms, physicians’ history-taking and physical methods and diagnostic tests (Sandella et al. 2013). This conclusion dangerously presumes that since spinal stenosis is not a "diagnosable" medical disorder because the lack of strict criteria, the decision to offer a specific treatment would be erroneous . CMS further states: “There are several fundamental limitations of the evidence that cause us to reach conclusions that disagree with the conclusions of the studies that have been used to support claims of clinical benefit. The absence of diagnostic consensus leads us to question whether the enrolled study subjects indeed have LSS, and if so to what degree. The absence of diagnostic consensus constrains any significant consensus on treatment." " The general reliance on case series rather than robust randomized sham controlled clinical trials with explicit protocol driven criteria further limits the persuasiveness of the evidence. "

This brings to light some points to consider:

1) If there is no clear cut diagnosis for spinal stenosis, why then does CMS has treatment options available? How could CMS come to a conclusion, that an image-guided, percutaneous lumbar decompression with statistically significant positive patient outcomes on studies with patient selection met 'impossible criteria', yet offer coverage for a spinal laminectomy with or without fusion with absolutely no similar controls to the elderly population?

2) How feasible is it that CMS makes an effort to put all patient criterion in one category when the human pain experience is extremely complex and variable? For us that deal with symptomatic LSS (neuroclaudication), we know that each patient diagnosis and treatment is best defined by a physician with subspecialty training in spinal disorders. It appears the studies reviewed were not done so in an efficient manner.

3) A "robust randomized sham controlled clinical trial" (Efficacy study) for any painful medical condition disorder would be particularly challenging in light of subjective nature of patients’ symptoms and the failure to adequately account for the biases and confounding that arise from placebo effects and spontaneous symptom improvement in the natural history of the condition. Efficacy studies can provide positive results in a controlled experimental research trial, in an almost mathematical paradigm that does not consider the human-psyche. What we found in clinical practice is that such studies do not represent what happens in 'nature' (clinical practice). Effectiveness studies use real-world clinicians and patients mimicking what happens in daily medical practice, thus pragmatic and less costly to perform and can also be done in a blinded randomized-controlled fashion, just like the numerous published PILD data. Isn't a wasteful approach, to study human pain, to require all new interventions to undergo laboratory conditions of sham vs. treatment? When it can be done in a more valid, realistic fashion? How reliably can be predicted that such Efficacy studies are applicable to modern healthcare?

I have made every effort to understand CMS’ proposed decision and considered the documented analysis presented. It continues to lead me to one conclusion, this decision makes no sense. I urge CMS to reanalyze the PILD procedure and conclude what hundreds, perhaps thousands of clinicians already have; this is a safe, effective treatment option for Medicare beneficiaries. The U.S. is a world leader in medical innovation and this decision will have a negative impact in future medical technology development. In light of the current opioid prescription abuse crisis, we don't have the luxury to deny better alternatives to our chronic back pain patients.

Alan Gonzalez-Cota, M.D.
President-Elect,Delaware Society of Interventional Pain Physicians (DSIPP)

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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 done, the safety profile is very high. Most importantly, disabling this modality, would limit the potential treatment options for patients that would otherwise have no options.

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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 effective treatments for this patient group. It seems odd to me that CMS would advocate surgery or “nothing” for these high risk patients. I have performed around 80 of these procedures and have seen great results for the right patient. I am also the co-author of a peer reviewed publication with Dr. Lingreen titled “Retrospective Review of Patient Self-Reported Improvement and Post-Procedure Findings for mild® (Minimally Invasive Lumbar Decompression)”, which was published in 2010. There are a few key items in the NCA that troubled me and I would like to address them in this comment. The first item is the NCA’s discussion about concerns around reporting of adverse events. In particular the statement that, “It is unclear why only a few studies reported adverse events of significance.” This comment seems to be at sharp odds with the article we published as well as articles published by Chopko, Wong, Levy, Mekhail, Deer, and Brown which all clearly indicated that no major adverse events or device related complications occurred. So, it is unclear what the NCA meant by this comment. If the implication is that adverse events were underreported than this is a very serious allegation against the study sites. One that, I believe, is not substantiated. Furthermore, I’m struck by why CMS is concerned about adverse events when CMS has already deemed this procedure to be safe enough for the ASC setting. If CMS is not satisfied with more than 20 published on mild (all of them which affirm the safety of the device) then I’m not sure what the standard is they are looking for. Quite simply this procedure has demonstrated itself to be safe because it is minimally invasive and to imply otherwise suggests a conspiracy of silence that as an independent investigator I can assure you is inaccurate. In my experience (and I think Dr. Lingreen would concur, the MILD procedure has demonstrated itself to be safe.

The second item I wanted to comment on was the statement “Clearly prospective, randomized trials comparing safety and efficacy of mild to other established treatments for spinal stenosis will be necessary” in our 2010 paper. This is a standard statement placed in most papers concerning new procedures and is in point of fact rhetorical in nature. Of course any new technology (which MILD was in 2010 would need other outside studies to confirm the results. It is important to know that it has been three years since we published this paper and a lot has been defined around the right patient selection criteria, efficacy, and safety since that time. The well selected patient for this therapy is a patient with spinal stenosis and ligamentum flavum as a dominant feature of the canal narrowing. The presence of neurogenic claudication in combination with these anatomic features suggests a high likelihood of success. This group often has few treatment options available to them which makes the CMS denial troublesome. In the opinion on criticism of the inexpensive and minimally invasive MILD procedure is that spinal stenosis is poorly defined as a clinical entity. This is in fact false, spinal stenosis is well defined clinically but less well defined by radiologic standards. If it is poorly defined with regards to candidate selection for MILD then conversely it is also poorly defined for open laminectomy. The acceptance of surgical decompression (laminectomy) suggest not debated. The clinical criteria for patient selection would be identical with establishment of ligamentum flavum hypertrophy on MRI review. I believe that this creates an unfair standard for minimally invasive procedure (compared with the highly invasive surgical alternative) leaving few treatment options for patients with neurogenic claudication who do not want or not deemed acceptable candidates for surgery. As noted this group of patients have few treatment options available that are as effective as MILD in my opinion. Both in our peer-reviewed research which is completely independent (not industry sponsored) and in my clinical practice significant numbers of patients enter our center unable to ambulate more than a few feet without claudicatory symptoms. Significant numbers (< 50% by our estimation) have significant functional improvement and improved pain control after a 45 minute procedure that does not even require sedation (in our hands). Rather than be a subject of review for non-coverage I would think this type of breakthrough would be hailed as an impressive step forward.

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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 higher-risk open surgical options.

I am double board certified in pain management and anesthesiology and a member of the American Society of Anesthesiologists, International Spinal Injection Society, Florida Society of Anesthesiologists, American Pain Society, American Academy of Pain Management, American Society of Regional Anesthesia and the North American Neuromodulation Society. I offer MILD to my patients because I feel that it provides them a proven LSS with neurogenic claudication treatment alternative to surgery. I have treated ~100 patients to date and have experienced significantly positive patient outcomes. I personally have had zero adverse events in my practice and according to the MAUDE database; the total adverse event rate for all commercial and clinical cases is extremely low (less than 0.1% in over 15k cases).

As a MILD course leader and proctor, I have the privilege of working with my peers to teach the MILD technique and establish patient selection criteria methods in their practices. Physicians from all over the U.S. have been trained to perform MILD, and have expressed interest in offering the procedure after reviewing the extensive research, joining discussions at relevant society meetings and learning of their peers’ impressive patient outcomes. Most LSS patients are between treatment options—conservative therapy has failed and they aren’t willing or aren’t candidates for open decompression surgery. The MILD procedure is cost effective, has comparable efficacy to the more invasive surgical approach, and is equally as safe as the available conservative, short-term therapies. Patients demand this treatment and denying them access to this care would be extremely disappointing and unfair to the Medicare patient population. Denying MILD as a treatment option would be taking a step back in the advancement of treatment options for LSS.

To conclude, I thought I should address an important point made in the draft memo- the need for “randomized sham controlled clinical trials”. Although these types of trials can be very effective and valuable in comparing treatment options, it would be illogical and unethical to enroll this patient population in this type of trial. A sham trial of MILD would result in:

A. Patients being denied treatment: The sham group of this trial would be denied care they are in desperate need of. MILD and open decompression candidates would have failed conservative, temporary treatments so if they were assigned to the control group, they would actually experience a reduction in care (i.e. going from conservative treatments to no treatment from a sham).
B. Extremely difficult patient enrollment: Asking patients to enroll in a sham study would be asking them to be randomly assigned to receive treatment or to receive NO treatment AND you can’t get additional treatments for a very long time. My opinion as a pain physician is that no patient would sign up for this and adhere to the protocol. Patients who do not experience pain relief in the sham arm would abandon the study and ask for a different pain treatment.
C. Unnecessary access/risk to sham group: The non-treatment group would be at risk for surgical infection and blood loss. Since the access portal would still have to be advanced to the sham group, patients would be exposed to a treatment setting, the stresses of having a procedure performed, and an open wound from the procedure site. Performing unnecessary access would not be in the best interest of this elderly patient population.

Sincerely,

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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 procedure and still continued to have severe pain symptoms. None of the cases were operated on due to any complications from the procedure. A large number of these patients have since stopped coming to see me as they do not have any pain issues and do not need any pain medications. It is important to note that I made every attempt to have a spinal surgical consultation for my patients before surgery. In addition all these patients did have all the conservative measures and simpler pain interventions performed before they were offered MILD.

Given the complicated nature of this patient base, some of these patients have needed further interventions for pain related to facet hypertrophy. This has been an issue in about 10% of patients. Sacroiliac joint pain has also been addressed in a small number of patients.

3 of my patients needed to be kept overnight mainly for logistical issues.

The procedure has been very well tolerated by all patients and they have had no postoperative complications from either anesthesia or surgery.

All my patients have received physical therapy after the surgical procedure and that has been extremely beneficial.

I feel very strongly that this procedure has been very beneficial and there is a lot of evidence indicating that the results are long lasting and can be done with minimal complications. It also costs significantly less than an open procedure. As our goal in health care is to try and improve the quality of life of patients, and decrease the cost of health care, MILD answers both the issues very well. I would make a strong case for continued coverage for the procedure.

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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 be reimbursed by CMS for chronic interventional pain procedures. CRNA's are non physicians, have no formal training in chronic pain management, have no evidence of outcomes and yet you have allowed that group of non-physician providers to perform these interventional procedures and collect payments. I am fully aware of CRNAs lack of training and expertise in this field as I was formally trained as a CRNA before spending nine years in medical school, internship, residency and fellowship in pain medicine. How can the same CMS organization have such a double standard regarding evidenced based outcomes?

In the past 18 months, I have performed in excess of 40 of these procedures. This procedure is not for everyone, but only those with spinal stenosis with neurogenic claudication and an overgrowth of ligamentum flavum in the posterior element of the spine. It benefits those elderly patients who are not generally considered surgical candidates for open lumbar operations. They are not candidates for open lumbar operations due to their age, co-morbidity or their desire to avoid a bigger lumbar operation. By not covering this procedure, I will be limited in what I have to offer this group of patients. This group of my elderly patient population will be less functional and less active leading to more health problems overall and incur more ongoing expenses to the healthcare system with repeated injections providing only temporary benefit.

I have tracked financial data of the first nine patients I performed this procedure on that I had a history with them in my clinic for at least 6 months. During those nine patient’s time with me, I had performed different interventional injections all with non-sustained benefits over the long term. Also, this group of patients was being prescribed narcotic pain medications and in this elderly group leads to more side effects and less activity. In these nine patients before the PILD procedure, CMS paid me $24263.51 to manage their pain patterns with procedures and office visits. Since the PILD procedure, CMS has paid me $4,281.32 for follow-up care for these same nine individuals. In other words, I simply either don’t need to see them anymore because they don’t have pain or the follow-up injections now work better and for a longer period of time. There is no other procedure I perform that allows my patients such good outcomes where I simply don't need to see these patients as often or at all because many of them simply don't have pain anymore.

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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 minimal.

I compare this to other currently available techniques that are far more invasive, have much higher complication rates, and recovery times can be a year. Furthermore only healthier patients can tolerate such procedures, leaving sicker patients without safe alternatives (minimally invasive alternatives). It is this patient population, those that are sicker and not surgical candidates that are the bulk of my patients, and without the MILD procedure they would be without effective care.

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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 the technique of percutaneous image-guided lumbar decompression (PILD) for the treatment of symptomatic Lumbar Spinal Stenosis (LSS), overall our field of neurosurgery has not embraced the use of this procedure due to concerns regarding its effectiveness as compared to our current surgical options. The present literature, which is predominantly industry funded, regarding the PILD is of low quality and demonstrates that this technique is not indicated in patients with a significant element of bony stenosis, lateral recess stenosis, or foraminal stenosis. While the literature suggests that the PILD procedure appears relatively safe, the improvements in the patients did not meet a minimally acceptable outcome based on the definitions. We have concerns about the characteristics of patients who would benefit from this procedure and the degree to which these patients would benefit as compared to current treatment options.

Thank you for the thorough analysis of the existing literature for the PILD procedure. We concur with the CMS conclusion and support the decision not to cover at this time.

William T. Couldwell, MD, PhD, President
American Association of Neurological Surgeons

Daniel K. Resnick, MD, President
Congress of Neurological Surgeons

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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 my opinion the "non coverage decision" will prevent a huge number of our elderly patients from getting the relief and the quality of life they deserve. In addition lumbar laminectomy surgery and repeated ESI are much more costly than the mild procedure.

Ideal patient selection is the key to success.

My suggestion is to continue coverage while collecting data on the efficacy, complications, and number of patients who fail and undergo lumbar laminectomy surgery. At the same time I would recommend to have strick patient selection chriteria:

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November 11, 2013

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

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 decompression a non-covered procedure for the treatment of lumbar spinal stenosis. We urge CMS to refrain from finalizing a non-coverage decision at this time.

As noted in the proposed decision memo, the core question is, “Is the evidence sufficient to conclude that PILD improves health outcomes in Medicare beneficiaries with lumbar spinal stenosis?” CMS reviewed a great deal of information and literature - most of which indicated that the answer to that core question could be yes. Comments received in response to CMS’s initial analysis supported coverage. However, in this proposed decision, CMS takes a different view because it believes the studies leave some important questions unanswered. These include, lack of consensus on diagnostic criteria, lack of consensus on the treatment of LSS, and specifically on PILD as a form of treatment. CMS also expresses some concerns about industry financial support for some of the studies.

A non-coverage decision at this time is premature and could deny care and relief to patients who may benefit from the procedure. We understand that PILD is not necessarily appropriate for all patients with LSS and that there must be clear guidelines in place to determine patient selection for this procedure. We ask that CMS allow opportunity for interested stakeholders to address the concerns raised in the decision memo so that the core question can be fully considered and definitively answered.

Thank you for consideration of our comments,

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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 ANOTHER.

CENTRAL STENOSIS CAUSES PAIN THROUGH THE BUCKLING OF THE LIG. FLAVUM WHICH IN IT'S TERM CAUSES COMPRESSION OF EPIDURAL AND SPINAL COLUMN BLOOD VESSELS. INSUFFICIENT BLOOD FLOW CREATES CLINICAL CONDITION NEUROGENIC CLAUDICATION( PAIN DURING WALKING, STANDING AND PROLONG EXTENSION OF THE LUMBAR SPINE.

FOR 20 YEARS OF MY PRACTICE I HAVE NEVER SEEN NEUROGENIC CLAUDICATION(NOT LOW BACK PAIN) IN PATIENT WHO DO NOT HAVE CENTRAL LUMBAR SPINAL STENOSIS CAUSED BY THICK LIGAMENTUM FLAVUM.
FROM THE STUDYING ANATOMY I KNOW THAT BECAUSE THE WAY HOW IT ATTACH TO THE SUPERIOR AND INFERIOR LAMINA IT CAN BUCKLE ONLY FORWARD MEANS ANTERIOR CAUSING LUMBAR COMPRESSION. BY CUTTING THE LIGAMENT ATTACHMENT AND REDUCING THICKNESS OF THE LIGAMENT BY UTILIZING MILD PROCEDURE LIG FLAVUM NOW IS ABLE DURING MOVEMENT TO BEND TOWARDS LOWEST PRESSURE GRADIENT WHICH OUTSIDE OF THE SPINAL CANAL THUS DECREASE INTRASPINAL PRESSURE AND REDUCE NEUROGENIC CLAUDICATION.

I HAVE FOUR CASES SO FAR. ALL PATIENTS HAS ONLY NEUROGENIC CLAUDICATION PAIN IN THE LOW EXTREMITIES. WITHOUT WALKING NONE OF THE PATIENT HAS LOW BACK OR LOW EXTREMITY PAIN. TO VERIFY THAT FACET ARTHROPATHY IS NOT AN ISSUE I DID DIAGNOSTIC FACET BLOCK WHICH FAILED TO IMPROVE PAIN, NEITHER LUMBAR EPIDURAL HAS ANY RESULTS MORE THE 3-4 DAYS

THE FIRST PT WAS DONE 6 MO AGO. HE STILL DOES NOT HAVE ANY LOW EXTREMITY PAIN DURING ANY DISTANCE OF WALKING. TIGHTNESS IN THE LOW BACK IS STILL PRESENT WITH AMBULATION THE SECOND PATIENT 4 MO AFTER THE PROCEDURE REPORTED COMPLETE RELIEF LEFT THIGH PAIN DURING WALKING WHICH WAS THE WORSE PRIOR Sx.BUT LOW BACK PAIN REMAINS UNCHANGED. PATIENT IS WILLING TO HAVE THE SAME PROCEDURE AGAIN IF IT HELPS FOR THE LOW BACK PAIN, BUT DOES NOT WANT EVEN CONSIDER CONVENTIONAL SURGERY.
CASE #3 DONE 2.5 MO AGO. WOMAN WITH SEVERE NEUROGENIC CLAUDICATION IN UNDERWENT MILD PROCEDURE.SHE HAD SEVERE LUMBAR SPINAL STENOSIS WITH SPONDYLOLISTHESIS BUT ABSOLUTELY REFUSED TO HAVE LAMINECTOMY. MILD PROCEDURE WAS SUCCESSFULLY DONE ON THE RIGHT SIDE, BUT IT WAS IMPOSSIBLE DUE TO TECHNICAL REASON TO DO IT ON THE RIGHT SIDE. AS A RESULT SHE REPORTED COMPLETE PAIN RELIEF ON THE LEFT SIDE ONLY CASE # 4 WAS DONE 5 DAYS AGO. PHONE FOLLOW UP IS REMARKABLE FOR NO LOW EXTREMITY PAIN

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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 geriatric population. Untill recently conservative modalities and possible neuraxial injections were the only option before ultimately presenting the more definite options to such patients that would be suregery. Obviously that involved the associated risks and time for the rehabilitation even for the most conservative surgery. Geriatic population with and without significant medical comorbidities were left with either take the more aggressive approach some times leading to placement of hardware versus living a life with much declined quality of life and at times with no quality of life. MILD was percieved as an approach less aggresive than surgery but with the potential of real results. Obviosly just like with any procedure or surgery it is not associated with 100% success but over the course of past few months we have seen significant improvement in quality of patients including every day activities in majority of patinets who underwent this procedure. All of them on outpatient basis with minimal anxiolysis and sedation and none of them with any major complications.

We as providers understand that just like any other procedure there should be comprehensive trial of non invasive treatment options and a decision for any kind intervetion be taken keeping all perspective in minds including success and failures. This stands ture for any treatemnt including comprehensive and open spinal decompressions with and without spinal fixation. However MILD has the advantage of percutenous approach with much shorter reovery time without having to go through long anesthesia times.

It is understandable that radiological findings in patients with LSS not always corerelate with symptoms. This is consistent with many other conditions like Osteoarthiritis of major weight bearing joints. It does not meant that treatment options be limited for those conditions ALSO.

If there is no consenus on traetment alogorithim for LSS , would other form of treatments like surgery or physical therapy be also reconsidered for coverage under CMS?.
Long term outcome are still unknown since the procedure has not been around for much long. What if over the next five years favorable outcome matches open decompression.
Many disciplines in medicine are favoring for less invasive or minimally invasive approaches tackling challenges which in past took a lot of resources and toll on patients, treatment of the most common cause of back pain in eledrly patients should not be an exception. For several of qualified patients this was a life changer. Many others should not be denied of this opportunity. An opportunity which is less expensive, shortens hospital stays or for that matter eliminates hospital stays and may help improve the quality of life enough so that they may participate in essential activities in their lives without having to think several times.

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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 painful lower limb neurogenic claudication (NC) and hypertrophic ligamentum flavum as a contributing factor. The following are responses and clarifications related to specific concerns mentioned in the NCA proposed decision memorandum.

I. The study was designed to have 20 subjects per group but ended up having 21 in the experimental group and 17 in the control group without explanation as to why it was different than the trial design.
Trial imbalances in arms are common in randomized studies and are often due to use of blocked designs, as described in the study report itself. This is not an uncommon occurrence and was explained. The following is a quote from the peer-reviewed publication of this study: “A total of 38 patients were randomized into the 2 treatment groups, with 21 patients in the mild group and 17 patients in the ESI group. As patients were sequentially randomized and assigned randomization numbers were not replaced in the event a patient was randomized but not treated, the number of patients in each treatment group is not precisely the same.” (1)

II. Blinding was not adequate or confirmed.
Not only was blinding perfectly adequate, but the adequate concealment allocation practice was achieved, which has a much larger effect than blinding (2), a fact that appears not to have been acknowledged in the NCA. To reiterate the blinding protocol, neither the enrolling physician nor the patient was aware of the patient’s ultimate treatment group. Upon enrollment, a patient enrollment form was completed and each patient was assigned an identifier number applicable to each study arm. At the beginning of the procedure, the assigned enrolling independent physician was unblinded and the procedure was carried out. Conscious sedation was used for all patients during the procedure to make sure that they were unaware of the specific procedure. The patients, as well as the pre- and postoperative staff, remained blinded throughout. After the procedures were performed, all patients were followed postoperatively by an independent third party, and only at six weeks, were all patients unblinded to their treatment group, and cross-over was offered.

III. Patients in the mild group underwent procedures bilaterally and at different levels, whereas patients in the ESI group had only one injection.
All patients, whether randomized to ESI or the treatment group, had an epidural needle placed within the epidural space and had the mild procedure portal placed at each spinal level and side that had pathology. The post-operative wounds were the same. There was no way for a patient to know their treatment arm.

To maintain the integrity of the double-blind, randomized trial, the ESI cohort could not receive more than one ESI or the patients would become unblinded to their randomized cohort. In general practice, multiple epidural steroid injections are administered at various intervals, yet the efficacy of ESI as a treatment option can be observed after the initial injection. If the initial injection fails to provide the patient relief subsequent injections will not provide a different outcome.
ESI was used as a comparator because it is often performed in the treatment of LSS patients prior to surgery, and it allowed the patients to be blinded

IV. Short-term outcome of 6 weeks with only the experimental group reported at 12 weeks.
Patients were excluded from the study if they had previously been treated with ESI within 6 weeks of the study procedure date. This timeframe was determined for the exclusion criteria as sufficient amount of time for the effects of the epidural steroid to wear off and be out of the patients’ system. This same amount of time, 6 weeks, was determined appropriate to unblind the patients to their treatment group and offer cross-over to the other treatment since the short-term outcome experienced by patients in the ESI cohort had been recorded.

The data shows that patients in the ESI treatment group mean VAS was 6.4 (95% CI + 1.0) at baseline, compared with 6.3 (95% CI + 1.4) at 6-week follow-up, a negligible improvement of 0.1 points (95% CI + 1.0), which was not statistically significant (Tukey HSD test P > 0.05). Patients in the mild treatment group experienced a statistically significant improvement in VAS from baseline to 6-week follow-up (Tukey HSD te st, P < 0.01). In this group, the average VAS baseline score of 6.3 (95% CI ± 0.7) improved to a mean of 3.8 (95% CI ± 1.3) at 6-week follow-up, an improvement of 2.5 points (95% CI ± 1.5). (1)

At 6 weeks patients were unblinded and 15 of the 17 ESI patients chose to cross-over to mild and went on to experience similar improvements as the original mild cohort. Reporting the remaining 2 ESI patient’s outcome results at 12 weeks would not have been representative of the group as a whole and of little statistical value. After 12 weeks, the remaining 2 patients from the ESI group did cross over to mild. The drastically different outcomes experienced by the two treatment groups at 6 weeks strongly support the adequacy of the blinding and cancels out any possible placebo effect.

V. The change in VAS and ODI in the mild group from week six to week 12 was not significant.
PILD patients in our study experienced immediate relief of symptoms, and this significant improvement in VAS and ODI was sustained through all follow-up time periods versus baseline. Therefore, and importantly, this durable improvement means that we would not expect a change in VAS or ODI values between follow-up periods. The durability of treatment with PILD experienced in our study is supported by the Cleveland Clinic study on the mild procedure which reports: “the Tukey HSD test demonstrated that dramatic improvement occurred by the first postoperative visit and showed a lack of difference between each subsequent postoperative visit, indicating a high degree of consistency of the initial result over time.”(3) Also in regard to open surgical decompressions surgery, as noted in the SPORT article, by week 6, the significant improvements in pain and function from baseline have been achieved, and each follow-up visit data point, although still significant as compared to baseline, are not statistically significant between the follow-up visits (4). Therefore, it is difficult to appreciate NCA’s concern regarding this point.

VI. The ZCQ difference between groups was not significant at week six.
As indicated in the publication (and supported by the literature, see references (5)-(7)), treatment is considered successful if the average ZCQ score is less than or equal to 2.5. In the case of the mild treatment group, a ZCQ Mean Patient Satisfaction score of 2.2 was achieved at 6-week follow-up (compared to 2.8 for ESI). Even though a statistically significant difference was not achieved at week 6, it is important to recognize that those receiving the mild treatment continued to improve to a ZCQ mean score of 1.8 at 12 weeks, which is well within the guidance for successful treatment. Additionally, it is clear that the ESI cohort had greater dissatisfaction with their treatment as evidenced by the fact that 15 out of 17 chose to crossover at week 6.

VII. Did not clearly define which definition of conservative care was used and lacked details of co-interventions.
There was no statistical difference in the baseline demographics and clinical characteristics of the treatment groups. The comorbidities, pain medication, and failed conservative therapies were similar in each group. The standard of care would have included, but not limited to, physical therapy, back brace, bed rest, walking aids, ESI, chiropractic, acupuncture, the use of anti-inflammatory drugs and opioid analgesics. The study protocol included use of narcotic and/or non-narcotic analgesics as needed by patients in the study group according to standard of care.

I stand behind the findings of my double-blind, randomized, prospective study of ESI vs. the mild procedure in the treatment of LSS patients suffering from symptomatic neurogenic claudication; mild provides statistically significantly better pain reduction and improved functional mobility vs. treatment with ESI. The results of our study are supported by Fukusaki et al. (8), who conducted a randomized study and also concluded that ESIs have no beneficial effect on neurogenic claudication. These authors state that “symptoms of pseudoclaudication [neurogenic claudication] are clearly not inflammatory” and “Epidural steroid did not produce a beneficial effect on the pseudoclaudication.” With an established understanding that conservative therapies including ESIs will not provide long-term relief to patients suffering from neurogenic claudication because a mechanical decompression procedure is required, I urge you to consider mild as a safe, effective, and minimally invasive alternative for these patients. The high standards that have been demanded by CMS in the proposed draft, unfortunately have not been consistently applied to other CMS covered procedures, including treatments for LSS such as laminotomy and laminectomy. It is stated in the memo that interventional pain procedure studies must have strong randomization, blinding, and controls before one can draw conclusions on efficacy, which I believe I have provided in my mild vs. ESI study. I strongly suggest a positive National Coverage Determination for mild so patients have a choice when choosing a decompression procedure to treat neurogenic claudication.

In closing, I would like to emphasize my dismay regarding the unique and unprecedented hurdles to which this procedure has been subject. It would be a disservice to the citizens of this country to deny access to a nonsurgical, safe, and efficacious procedure that has been shown to decrease pain and suffering while restoring function.

Respectfully yours,

Lora L. Brown, MD

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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 soon realized that there is a definite learning curve to be able to do PILD effectively. Also I learned very quickly that patient selection is the most important criteria to obtain good to exceptional results.

Mrs H was wheelchair bound when she was referred to me. She had a several serious comorbidities including severe Diabetes and CAD. She had severe spinal stenosis mostly secondary to ligamental hypertrophy. Multiple surgeons evaluated her and no one wanted to operate on her because of her comorbidities. I knew the fist time I saw her that she was the going to do well based on her imaging. Now she walks unassisted. I have not seen in my office for over a year only because she is doing so well but always sends me cards on every holiday.

I don’t want to make my letter about patient examples but I have seen way too many good stories that made me a believer in PILD for the treatment of spinal stenosis.

This procedure fills a huge gap that we have in the treatment of spinal stenosis. In clinical practice, I see patients with so many different needs. After failing conservative treatments, the only options left is PLD or open surgery. Some are too sick to have open surgeries, some are too young and active to have major back surgeries and some are completely against having surgery. The MILD procedure fitted perfectly for those patients. The outcome was remarkable. The safety profile is even more impressive.

I have read carefully the NCA. The arguments mostly revolve around the diagnostic criteria, the consensus for treatment and the clinical evidence for efficacy for the MILD procedure.

In regards to the diagnostic criteria and consensus for treating spinal stenosis, the same can be said for any available treatment specially surgery. I can only ask why is spinal stenosis an acceptable diagnosis for a major surgery like a fusion but not for PLD??

In regards to the efficacy, I agree that larger studies with longer follow up are needed. However the evidence is there to a certain extent. Anecdotally, after doing many of these procedure, I can testify that I have seen great success with it many times. I stand strongly in favor of allowing coverage for this procedure and against the NCA.

If this NCA succeeds in taking the coverage away, this procedure will vanish. I can comfortably say that in the past 10 years, this procedure is the most innovative and avant-garde spinal treatment that was offered. It is simple and extremely safe. I always compare it to the time when angioplasty started taking away from bypass surgery. This is what spinal surgery needs, this is why surgeons are fighting against this procedure.

PLD is in its infancy and we learning about it every day, more with every single case that I do. What we need to work on is have a better patient selection criteria. We cannot just stop doing it. It is absurd to stop doing it because it is so safe and so effective when patient are picked right. What we also need, is to help developing newer tools and instruments to make the procedure more effective.

Americans are living much longer. They have many comorbidities but they want to stay active and pain free. Moderate to severe spinal stenosis is the number one cause of their back problems. You will never see a 90 year old lady undergo spinal surgery. I have personally done the PLD on a couple of dozen patients beyond the age of 90 with amazing results. This is what our patients want, this is what the patients need.
I would be more than happy to provide more clinical insights and patient testimonial if needed. Please do not hesitate to contact me.

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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, transfusions, nerve injury, dural tears, prolonged hospitalizations and recovery. "PILD" pocedures avoid the higher risks of these major surgeries yet helps the patient resume more normal activities of daily living(AOL's).

I implore you to support and even promote this important pain procedure modality as it is a critical tool in helping our elderly patient population who have severe neurogenic claudication and cannot risk undergoing major surgical decompression.

This is one treatment modality that can have lasting and dramatic effects on mobilizing our severly diabled patients who are high risk for becoming more deconditioned and disabled.

Again this is one treatment modality that deserves to be supported and even promoted to be provided to our aging population of patients as they develop acquired lumbar spinal stenosis that disables them. Thank you.

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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 patients with an option for treatment, when surgical intervention was too risky or denied due to medical risk.

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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 mind. He is a World War II Veteran who had extensive treatment for his spinal stenosis and neurogenic claudication. He presented in my office and shared that he wanted to attend a WWII Veteran Memorial back east, however he felt he was unable to attend due to his symptomatic pain. I performed the PILD procedure on this patient, and am happy to report not only a favorable outcome, but this patient was able to attend his memorial. It is astounding that CMS would ignore such facts. CMS proposed decision states; Symptomatic patients typically present with symptoms of radicular leg pain or with neurogenic claudication (pain in the buttocks or legs on walking or standing that resolves with sitting down or lumbar flexion). Indications for surgery appear to vary widely, and rates of procedures vary five-fold or more across geographic areas. (Weinstein et al. 2008). This statement should be understood with further clarification that medicine cannot be practiced in such a way that each patient is treated the same. Each patient treated presents with a history unique only to them. This is why conservative measures vary.

CMS further states that the evidence does not support a conclusion of improved health outcomes for our Medicare beneficiaries. Has CMS taken into consideration the number of Physician’s performing the PILD procedure in Medicare jurisdictions that currently cover it? In California, Palmetto GBA has deemed the PILD procedure medically appropriate. LCD L28248 states “Section 1862(a)(1)(A) of the Social Security Act states that Medicare may NOT pay for care this is not reasonable and necessary for the diagnosis and treatment of illness (or for malformed body part). Additional guidance as to “reasonable and necessary” care under Medicare is found under the Medicare Program Integrity Manual (Pub. 100-08, Section 13.5.1) and in HCFA Ruling 95-1 (Section V). In review of Medicare Integrity Manual, Section 13.5.1 it states; A service may be covered by a contractor if: It is reasonable and necessary under 1862(a)(1)(A) of the Act. Only reasonable and necessary provisions are considered part of the LCD. Reasonable and Necessary; In order to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is; Safe and effective; Not experimental or investigational; Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is (a) Furnished in accordance with accepted standard of medical practice for the diagnosis and treatment of the patient’s condition or to improve the function of a malformed body member (b) Furnished in a setting appropriate to the patients’ medical needs and conditions (c) Ordered and furnished by qualified personnel (d) One that meets, but does not exceed the patients’ medical need, and (d) at least as beneficial as an existing and available medically appropriate alternative.

With regards to the Medicare criteria notes above, the PILD procedure far exceeds your expectations. The requirement to be furnished in accordance with accepted standard of medical practice for the diagnosis and treatment of the patient’s condition or to improve the function of a malformed body member I offer my insight above in regards to my WWII Veteran, this patient was unable to in such a manner to be honored as a Veteran however by performing the PILD procedure I was able to restore that right and honor. I am certain there are hundreds if not more similar outcomes my fellow colleagues could offer to support that PILD far surpasses this criteria.

In order to be deemed medical appropriate CMS states that the procedure must be furnished in a setting appropriate to the patients’ medical needs and conditions. Please take note that in 2013 CMS deemed the PILD procedure appropriate in an Ambulatory Surgery Center setting. This can be located under the Federal Register Volume 77, No, 221 Dated, Thursday November 12, 2012 from the Department of Health and Human Services. Additionally, CMS had in the past deemed a reimbursement rate for the PILD procedure in a OPPS setting. This was a documented “News Flash” from July 2011. It is safe to assume that PILD had met the criteria to be appropriate when performed in an OPPS or ASC setting.

CMS further indicates the procedure should be ordered and furnished by qualified personnel. Over 450 Physicians have been identified, trained and are subsequently performing the PILD procedure. It makes sense to one could deduce that with favorable outcomes as well as no adverse events that these treating Physicians are qualified. Finally, CMS requires the procedure to be one that meets, but does not exceed the patients’ medical need, and is at least as beneficial as an existing and available medically appropriate alternative. PILD procedure by far exceeds a patients need whom is properly qualified for this procedure, further it is far MORE beneficial than the existing alternative(s) e.g. Laminectomy and/or spinal fusion.

Further reviewing the Medicare Integrity Manual it was noted Chapter 13.7 – LCD Development Process. Under Chapter 13.7, please note 13.7.1 in which clearly states when reviewing a procedure for coverage “Less stringent evidence is needed when allowing for individual consideration or when reducing to the least costly alternate”. I question, in fact if CMS applied this rule when considering the PILD procedure. One would presume not considering there exists no NCD for spinal laminectomy and/or fusion, and one LCD regarding the same which exists in Florida. It begs the question why CMS would apply such high standards that it currently and obviously does not apply to its covered procedures?

These are only few of the many questions surrounding this proposed CMS decision. I strongly urge CMS to reevaluate its decision and come back with the right decision for all involved. More importantly, please consider you Medicare population and the damaging impact this would have on their health outcomes.

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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 MRI evidence of central spinal canal stenosis of less than or equal to 1cm due do posterior canal thickening secondary to hypertrophic ligamentum flavum whose symptoms are relieved with lumbar flexion. Current treatment for LSS is limited to epidural steroid injections, which provides relief for a limited period of time and becomes less effective as the stenosis progresses, or surgical decompression which is associated with greater morbidity than PILD.

Many patients who are appropriate candidates for PILD are not appropriate for surgical decompression due to medical conditions which limit their being appropriate for anesthesia. While no treatment is 100% successful my experience with PILD is that it is more effective and durable than epidural steroid injections and for most patients, provides them with enough pain relief to avoid full surgical decompression with anesthesia. This procedure is not a substitute for full surgical decompression, but instead is a valuable, less invasive, less expensive option for patients who wish to avoid or are not candidates for anesthesia or surgical decompression. PILD avoids the epidural scarring and spinal instability associated with surgical decompression. With respect to duration of benefit, I have seen patients receive benefit for more than two years who have resumed their normal activities and avoided the complications associated with more invasive surgical decompression. Both my experience, and published literature suggests that many patients receive extended (>2 years) duration of benefit which is well beyond what one would expect from a placebo response.

In my practice, fewer patients have required to proceed with advancement to full surgical decompression since the availability of the PILD procedure. It would seem that a reduction of the number of patients requiring surgical decompression for LSS is beneficial to both the patient and to CMS. With respect to the question of plausible mechanisms of action, it is clear that patients with LSS that are able to control their symptoms with conservative care (epidural steroid injections) may progress to being less responsive to conservative care and epidural steroid injections over time. During this time where patients progress from being responsive to conservative care to being unresponsive to conservative care is often not associated with a significant change in the MRI findings. This observation suggests that the degree of increased pathology that caused a patient to progress from being responsive to conservative care and not being responsive is not necessarily appreciated by changes in the MRI. Thus, the amount of decompression needed to provide symptom benefit, as provided by PILD, may also minimal.

Finally, I have not encountered any serious complications with the use of PILD but I have taken care of many patients who have persistent complications after surgical decompression. The PILD procedure fills a specific and unique void in the treatment continuum for LSS and is not only beneficial for patients, but for CMS as well as it is less expensive than surgical decompression with fewer complications.

I strongly urge you to reconsider your proposed decision and recommend PILD continue to be a covered Medicare procedure.

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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, the options include medications, epidural steroid injections or surgery. In elderly patients, all of these procedures carry significant risks that must be weighed against potential benefit. In the vast majority of cases percutaneous lumbar decompression has a favorable risk to benefit profile compared to any of these options.

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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 established that procedures such as laminectomies or spinal fusions are eligible for coverage with the full knowledge that these procedures treat spinal stenosis. Thus, it seems contradictory that a lack of consensus on LSS treatment should form the basis of a non-coverage decision. Similarly, the perceived lack of consensus on diagnosing LSS does not appear to be a barrier for these procedures as well. CMS's coverage policies make it clear that CMS will extend coverage for a therapy even when they believe there is no consensus on treatment and diagnosis of LSS.

A diagnosis of LSS can include a broad range of subgroups of patients and this does not appear to be uncommon for published data on procedures already approved by CMS. The following studies illustrate examples of a wide range of diagnoses for procedures that CMS has made eligible for coverage:

These diagnoses and treatments are recognized by CMS as being acceptable and eligible for coverage. The patient selection criteria for the PILD, by contrast, seem extremely restrictive. All patients need to have a diagnosis of LSS with neurogenic claudication, have failed conservative treatment, and have hypertrophic ligamentum flavum as the main contributor. Many of the studies have even specified the symptomatic diagnostic tests (pain when walking or standing that is relieved with flexion) and ligamentum flavum thickness (>2.5 mm). In 2012, Levy and Deer [7] reported on 373 patients in a safety review and meta-analysis and established that all patients presented with neurogenic claudication in addition to failing conservative treatment such as physical therapy, analgesic and anti-inflammatory medications, and epidural steroid injections. Following these criteria, the paper reported one-year efficacy data that demonstrated statistically significant improvement in the patient's pain and mobility. I am left with the paradox that CMS plans to deny coverage for PILD but will continue to approve lumbar discetomies, laminectomies, and spinal fusions despite the fact that PILD has more restrictive selection criteria. This makes very little sense to me especially when one considers the low complication rates, cost-effectiveness, statistically significant pain reduction results, and overall success rates of the PILD. I urge CMS to reconsider its position.

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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 stenosis poses a significant challenge to the persuasiveness of the available evidence that might be used to support PILD coverage.” Spinal stenosis is a complex condition. It is also a very common condition, and millions of patients are diagnosed and in treatment each year. Spinal stenosis can be defined as “a narrowing of the spinal canal with encroachment on the neural structures by surrounding bone and soft tissue. Patients typically present with radicular leg pain or with neurogenic claudication (pain in the buttocks or legs on walking or standing that resolves with sitting down or lumbar flexion).¹” It is typically caused by degeneration, so as the spine loses height and patients become weaker/less stable, things shift and there are often multiple cofactors contributing to the stenosis, or narrowing. These contributing factors lead to a variety of symptoms. Decompression procedures are often recommended for these patients because the canal requires a mechanical change to address the stenosis. Current decompression treatments (such as Laminectomy/Laminotomy, fusion) take a broad approach, attempting to treat multiple causes of the canal impingement at once.

To be very clear, MILD does not approach stenosis as a whole. MILD treats Lumbar Spinal Stenosis (LSS) with neurogenic claudication and addresses just one causal factor- the hypertrophic ligamentum flavum. I have found that these patients are not hard to find if you pay close attention to the symptoms. This truly is a condition where you “treat the story”. In this case, “the story” is a patient that is unable to stand for long periods of time or walk for very long distances because they feel pain or weakness in their lower back, buttocks, or legs. The discomfort is relieved when the patient sits or bends forward at the waist. This has been clearly defined and outlined in the 10 clinical trials conducted on MILD and in the 16+ published clinical journal articles. MILD is not a fix all and treats a specific condition and very specific patient population. As physicians, it is our responsibility to do right by the patient. For example, we should elect for conservative treatment before more dangerous options and always clearly define and diagnose the patient condition prior to recommending treatment. Unlike what was suggested in the CMS draft policy, patients presenting with “back pain” are not treated based on a broad generalization of their symptoms. Extensive symptomatic and imaging reviews are completed prior to offering a treatment plan. For MILD specifically, there has been clearly established and reproducible diagnostic criteria to identity LSS with neurogenic claudication:

A. Review of patient symptoms. Neurogenic claudication is easy to identify via patient symptoms: Patient has difficulty standing or walking for long periods of time. When ambulating, patient experiences pain, weakness, tingling, or numbness in the low back, legs and buttocks and reduces with flexion (sitting, bending forward at the waist, lying down). In practice, these symptoms are self reported through patient questionnaires as well as discussed and filtered through by the treating physician.

B. Review of patient imaging. MRI (preferred) or CT scans allow the treating physician to identify the level of stenosis, and correlate the patient symptoms to the imaging. Once the level has been identified, the causal factors can be determined using measuring tools and canal space/shape. If the hypertrophic ligamentum flavum is a main contributing factor, causing a trefoil shaped canal and the patient does not have any access limitations, they are considered as a candidate for MILD.

MILD patient selection criteria has been reproduced and applied to several studies, which have provided durable safety and efficacy outcomes:

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 money. Medicare should be thinking more about the patient and how much money they could save by using this procedure instead of more invasive procedures which are not always successful and at times leave the patient worse than when they started. Even if this procedure did not always help at least it didn't make things worse which cannot be said of more invasive procedures. At the very least it is a place to start before going to the costly and more invasive procedures. [PHI Redacted] As a lay person, I can understand why hospitals and surgeons don't want this procedure approved. It would take money out of their pockets. Please consider the patients [PHI Redacted] who could be helped without having to go through extensive surgery.

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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 after the MILD procedure.

The response has been very significant and a large number of these patients have stopped coming to our practice. This is extremely encouraging. They have also indicated to me that it would have been so much nicer to have had this procedure available 10 or 15 years earlier as it would have allowed him to enjoy their senior years so much better.

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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 glance, they do not stand up to the data published on the procedure and my personal experience of over 150 patients treated over the last three years. If one takes the body of evidence for this procedure it includes around 20 publications with multiple patient outcome measures over multiple time periods. Mekhail, et. al, Deer, et al., and Levy, et. al. all used multiple validated outcomes measures such as ODI, ZCQ, Roland Morris Questionnaire, and VAS. There are three important items of note in these studies: 1) All showed clinically relevant and statistically significant results over a long period of time, 2) All showed improvement over multiple outcomes measures, and 3) All showed significant responder rates (81% in the Levy publication). To my knowledge, no study on long term placebo effects has been able to demonstrate significant improvements in outcomes sustained over a year or responder rates that are in the 80% range. Add on top of this the fact that these studies were conducted over at least 15 sites and the probability of an “across the board” placebo effect becomes very doubtful. In case CMS is still not convinced, I urge you to relook at the Brown publication. This was a study that was blinded and randomized with a crossover option. You can clearly see that there was a difference in response in the two cohorts. All individuals in the ESI cohort crossed over (15 out of 17 did so at 6 weeks) and their response to the mild procedure was very similar to the mild cohort. How can placebo effect explain this? I can’t think of a logical argument.

The NCA then goes on to recommend a standard of a randomized controlled trial to demonstrate long term efficacy. I believe this recommendation does not take into account the nature of pain treatment and this procedure. Pain treatment is about relieving someone who is often in great pain. In other words…relieving the symptom is often the main consideration for treatment. So…designing an RCT where the comparator is no treatment or a sham is out of the question. How can you ask a patient that has usually been on analgesics and has failed multiple conservative treatments to enroll in a study where they get NO treatment and have to stay in that cohort for at least a year? I can’t think of any well designed long term RCT in interventional pain that has been successful at doing this. If this is the standard, you are actually asking the patient to go BACKWARDS in their treatment protocol (i.e. going from trying multiple conservative treatments, analgesics, etc. to going to no treatment). The next option may be an alternative treatment option such as surgery or a non-surgical treatment. The non-surgical treatment is not an option since these patients, by patient selection criteria, must have failed conservative therapies to be a PILD candidate. Even if this was not a criterion, pain studies have had difficulties running randomized clinical studies with non-surgical treatments as a cohort. All one has to do is look at the failure of randomization of the SPORT study where only 63% of the “surgical” cohort had surgery at a year and 42% of the “non-surgical” cohort had surgery at a year. When it comes to pain treatments, it is just extremely difficult to prevent cross-overs since patients will tend to do anything they can to seek an alternate pain relief treatment if the one they are on is ineffective. This leaves surgery as a comparator. This has countless challenges but let me focus on two main ones. It is impossible to conduct a blinded study and eliminate bias associated with having two different specialties provide treatment for only one of the cohorts. This is the case here. A surgeon performs the surgery and an interventional pain physician performs the mild procedure. This means it is impossible to blind this study. Secondly, I can’t conceive of the possibility of IRB approval or patients actually enrolling in a study with such dramatically different safety profiles. How can we expect to run a study comparing an outpatient procedure with extremely low complication rates to one that requires 2-3 days in the hospital, lengthy recovery, and higher risk of complications? If a patient is truly a candidate for both procedures (which is required for eligibility of a comparative study) then who in their right mind would ever pick a surgery over a mild procedure?!

So…in summary, I would like to point out that CMS’s concern over study bias seems to be an improbable concern and the recommendation to do a study is an impossible standard for this procedure. In all of this CMS seems to have missed the fact that this therapy fits a treatment gap between conservative therapy and surgery. There are many patients that I have seen that have failed conservative therapies and are really high risk surgical candidates. What options do we have for these patients if mild goes away? These are the very patients who, due to their stenosis are likely to fall resulting in hip fractures and other injuries far more costly than the MILD procedure. I have been practicing chronic pain management for 35 years and have rarely seen a new therapy as effective as MILD. Parenthetically, I just saw two of these patients in my clinic that I did this procedure on last week who for the first time in many years are completely pain free and can stand erect without their walkers. They are two of over 200 that I have done with similar results. I urge you to reconsider your non-coverage decision.

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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 (LSS) and painful neurogenic claudication (NC) caused by hypertophic ligamentum flavum. Currently there are no minimally invasive treatment options for these NC patients that are suffering from pain and limited mobility. Conservative nonsurgical treatment options do not treat the underlying cause of the condition, therefore, only provide short term relief. The thecal sac compression in the central canal cannot be treated with conservative treatments including oral medications or epidural steroid injections because a mechanical decompression is required. A double-blind, randomized, prospective study by Brown examined the effects of the mild procedure versus epidural steroid injection (ESI) in patients with symptomatic LSS with neurogenic claudication and hypertrophic ligamentum flavum (>2.5mm on preoperative MRI or CT) as a contributing factor. The patients in the mild group had a baseline VAS score of 6.3, which improved to a mean of 3.8 at 6-week follow-up, an improvement of 2.5 points. The patients in the ESI group had a baseline VAS of 6.4, compared with 6.3 at 6-week follow-up, a negligible improvement of 0.1 points. For CMS to state that nonsurgical treatments already exist to treat LSS is inaccurate because these conservative treatments including ESIs will not provide long term relief of neurogenic claudication symptoms.

In my practice, I see patients that have failed to obtain pain relief and functional improvement from conservative treatments and are seeking the next treatment option in hopes to experience some long term relief of their symptoms. Historically, the only decompression procedure available that can offer long term relief is open decompression surgery (laminotomy, laminectomy, fusion). I have seen these patients faced with the prospect of open surgery and in my opinion they all fall into one of 3 categories. The first category is “too early”; the LSS has not progressed to the point where risk/benefit of undergoing open surgery is favorable. The second is an “ideal surgical candidate”; a patient that is otherwise healthy, can tolerate anesthesia, is willing to accept the risk of surgery, and has multiple severe issues that need to be corrected (e.g. foraminal stenosis, facet hypertrophy, disc bulge, etc.). The third is “high surgical risk”; the patient falls into a high surgical risk category because of co-morbidities (diabetes, obesity, etc.) and/or advancing age. mild provides a safe and efficacious alternative to open surgery in all 3 of these categories but there are no existing viable minimally invasive decompression options for the first and last category.

Dr. Chopko conducted a study where he treated “14 patients deemed to be at high risk for complications related to open spine surgery and general anesthesia” with mild. He concludes that “A statistically significant improvement in VAS scores was observed, with a reduction in pain of 53% compared with preoperative levels. The average 53% reduction in pain can be seen as a meaningful improvement in quality of life, with overall small risk. In addition, more than half of the patients exposed to long-term narcotic therapy were able to reduce or discontinue these drugs after the PRLL (mild) procedure.” There did appear to be two complications but upon closer reading, it appears that these were not related to the procedure itself but to the general health of the patients (the patient with the PE had a hypercoagulable state secondary to lymphoma and the patient with bowel incarceration was morbidly obese and had a long-standing history of intraabdominal issues). This study illustrates the options argument clearly. All 14 of these patients were deemed to be extremely high surgery risks and had no other decompression options other than mild.

In conclusion, I have to disagree that the current treatment options that already exist to treat LSS including laminectomies and nonsurgical options are sufficient for this large patient population. mild is a procedure that bridges the gap between conservative nonsurgical treatments and invasive open decompression surgery to provide a minimally invasive option to patients with lumbar spinal stenosis with debilitating neurogenic claudication. We cannot force Medicare patients to undergo high risk, invasive open surgery as the only means of relief, I strongly suggest a favorable National Coverage Determination of mild.

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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 successful long term outcomes (1 year) for 17 patients in our paper titled “mild interlaminar decompression for the treatment of lumbar spinal stenosis, procedure description and case series with 1-year follow-up”

As a radiologist, it was with great interest that I read your commentary on imaging relative to the mild procedure. The NCA states that “We cannot be certain that removing a few tiny segments of connective tissue with the PILD tool makes any real structural difference despite the fluoroscopy image of the patient bent forward during the procedure. As with any invasive procedure where tissue is altered, changes from the preoperative radiographic evaluation should correlate with outcomes after decompression. (Mattei 2013).” As an initial point, we should not ignore the fact that the Mattei reference is a “Letter to the Editor” and that the conclusions have not gone through a peer review process. Nevertheless, it is quite clear that Mattei spent significant time researching the issue of imaging and has come up with some interesting findings. First, Mattei states that “it has been demonstrated that there is a poor correlation between walking distance, Oswestry Disability Index (ODI), the 36-ItemShort Form Health Survey, EQ-5D, and the Visual Analog Scale for leg and back pain levels, on the one hand, and the dural sac cross sectional area as measured by MRI on the other”. Additionally, Mattei states that “All these results support the conclusion that, up to now, the correlation between lumbar canal dimensions and clinical symptoms in patients with neurogenic claudication is very poor, so that MRI by itself is not capable to differentiate between individuals with clinically meaningful spinal canal stenosis and asymptomatic control subjects with incidental finding of spinal canal measurements below the average expected levels for the normal population at that age.” This speaks to the issue that a correlation between MRI and spinal stenosis is far from established. Mattei then addresses the issue that CMS raised, namely “The most important question that each neurosurgeon should ask before indicating a surgical procedure for decompression of lumbar canal stenosis is how does the preoperative radiographic evaluation of the severity of lumbar canal stenosis correlate with outcomes after surgical decompression. A thorough search in the current literature as an attempt to answer this last question yielded only 1 result: a weak study with a very limited number of patients (27) in which the authors were only able to suggest in their conclusions that "there appears to be a relationship between severity of stenosis and outcomes of decompressive surgery such that patients with a greater than 50% reduction in cross-sectional area are more likely to have a successful outcome."” This seems to indicate that there is no established evidence that a difference in pre to post-op MRI is correlated to positive outcomes. This is further confirmed by the NCA report itself which cited the study by Haig. This casts doubt on CMS’s assertion that a measure of success should be a correlation between altered tissue and changes from the preoperative radiographic evaluation. Given this lack of standard, why would one consider change in fluoroscopic imaging as less relevant than an MRI? After all, fluoroscopy has many relevant advantages. First, the patient’s position does not change during the procedure, so it is fair to state that the change in the fluoroscopic image pre and post procedure is as a result of the procedure itself. Secondly, fluoroscopy allows for dynamic view of the area currently under treatment. This is particularly useful since the goal of the procedure is to reduce pressure sources on the central canal. An improvement in flow of contrast dye happens when restrictions to that flow have been removed.

All of this leads to an existential question on the treatment of LSS. If CMS requires correlation between outcomes and radiographic imaging for approval despite the fact that the published literature does not support this correlation and CMS uses this as a basis for denial of PILD then what does CMS propose for ALL LSS treatments? After all, existing treatments may be able to show changes in an MRI but that doesn’t necessarily translate to a successful outcome.

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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, so as to know who would benefit the most and who would not. Furthermore, I would agree that this modality should be offered by a very limited number of well trained experts in the field of interventional pain management. People who would treat the intervention as a true effort to improve the patients condition and not as one more financially beneficial step, which they hope will fail, before they proceed proceed with a more extensive and more expensive surgical intervention. At the same time, poorly trained individuals should allowed to offer this treatment either. Having said that, CMS is about to throw away the baby along with the placenta. Do not allow yourselves to be influenced by special interests groups and politicians.

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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 decompression)” in 2010. I have reviewed the National Coverage Analysis on PILD and urge CMS to reconsider its non-coverage proposal.

I have provided extensive information on the success of this procedure in my practice during the April 2013 comment period where I mentioned that I have seen 70% of patients improve. I will, therefore, simply reiterate my support of the efficacy of this procedure and refer you to my April 9, 2013 NCA comment for more detail. I would like to instead address the characterization of the article I co-authored. The NCA states: “The authors noted, “At present there are no clear-cut standards as to what constitutes radiologic spinal stenosis, much less ligamentum flavum hypertrophy.” While ligamentum hypertrophy is one of two inclusion criteria, the authors noted, “The lack of documented ligamentum flavum thickening for each patient is a drawback to the current study. Future studies could attempt to standardize the selection criteria of patients for this procedure with vigorous determination of ligamentum flavum thickness perhaps better predicting who will benefit from the procedure.”” The first thing to note is that this article was written in the early stages of commercialization of this procedure (2010) when clear patient criteria were still being established. Hypertrophic ligamentum flavum (for the purposes of this procedure) has been subsequently clearly defined in selection criteria in studies by Mekhail et al., Deer et al., Levy et al., Chopko, and Brown (1-6). In addition, the statement about lack of standards for radiological spinal stenosis have also been addressed by subsequent study selection criteria where strict inclusion criteria required a symptomatic diagnosis of neurogenic claudication followed by MRI confirmation of ligamentum flavum. The study that was cited by CMS (Sandella) actually echoes the best practices that we have seen in patient selection, namely that a physician can be very certain of diagnosing a clinical spinal stenosis patient (90% according to Sandella) by asking the right questions around pain/weakness when standing or walking followed by relief of symptoms when sitting or bending forward (7). Finally, most publications feature a commentary on potential weaknesses of a study. This analysis does not mean that the reader should dismiss the findings. If this were the case, almost all studies would be dismissed! The NCA does not appear to acknowledge the conclusion of the publication, which stated that “The mild procedure appears to be a safe and likely effective option for treatment of neurogenic claudication in patients who have failed conservative therapy and have ligamentum flavum hypertrophy as the primary distinguishing component of the stenosis.” That should be the main “take away” from the paper. Further comment for the overall “take away” is made that the call for ‘ligament flavium thickening’ selection criteria was meet as noted above as confirmation of the Sandella clinical criteria for neurogenic claudication, and in my experience of over 400 cases, the outcome has remained within a small percentage variant of 70 percent of the selected patients improving function, decreasing disability and pain scores with a minimally invasive outpatient procedure.

The continued study for lumbar stenosis as well as any other potential debilitating condition warrants more research to ensure clinicians continue to provide superior treatment options to human kind. This does not mean that we should stop using the best proven treatments at our disposal. The mild procedure is such a procedure that provides an important treatment to a large section of patients who have failed conservative therapy and are not candidates for open surgery. In addition, CMS cannot ignore that a treatment like this can provide a significant savings and lower safety risk. Once again, I urge you to reconsider and extend coverage.

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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 patients , due to their co-morbidities and anesthesia risk.

I think, we need to select patients with significant spinal stenosis with neurogenic claudiation, thereby obtaining excellent results.

As a pain physician, I treat on a regular basis innumerable patients who have failed open surgical procedure with wider laminectomies, with or without fusion, with or without instrumentation.
Diagnosis of lumbar spinal stenosis is essentially made by good history taking, and targeted physical exam. Conventional treatments, including physical therapy and epidural injection, after a series, if not giving improvements in functional status, minimally invasive procedure will be of great benefit. Why subject very old patients to extensive surgery, when MILD can be performed at a fraction the cost of surgery and post op Rehabilitation.
There are enough studies done to prove the efficacy of MILD procedure.Moreover ,MILD can be performed with intravenous sedation and local anesthesia.
The best case was a 92 year old lady ,who received complete relief of pain and improved functional status.

I hope the CMS will approve this procedure for the benefit of elderly mankind.

Sincerely,

Joey Thomas, M.D.

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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 general, LSS candidates for surgery have failed conservative measures or treatments for a specified period of time. The evidence-based guideline published by Kreiner et al. (1) recommends that patients who have failed conservative measures and exhibit mild, moderate, or severe LSS symptoms should undergo surgery unless contra-indicated. Although many procedures are covered by CMS, in general the progression both in terms of costs and complexity is decompression, decompression with mild arthrodesis, or decompression with complex arthrodesis.

A “real world” picture of surgery, however, has begun to emerge that portrays disturbing issues regarding a significant increase in complex fusions performed in the US. In 2010, Deyo et al (2) published in JAMA a retrospective cohort analysis of Medicare claims from 2002 to 2007, and found that in 2007 there were 37,598 operations that CMS approved for LSS patients at a cost of $1.65 billion for hospital costs alone. During the years analyzed, the authors reported that while surgical rates for decompression with or without simple arthodesis slightly declined, these rates increased for decompression with complex arthrodesis from 1% of all operations to a staggering 14.6% of operations over a six-year period. For operations involving complex fusion the rate of major medical complications was 5.2% versus 2.1% for decompression alone. Hospital stays were also longer for patients who had complex arthrodesis.

Many of the same authors listed on the JAMA publication also published a retrospective analysis of 2008 CMS claims in the Journal of Bone and Joint Surgery the following year (3). The researchers reported an overall reoperation rate at 4 years of 10.7% for surgical decompression with or without simple arthrodesis compared to 13.5% for patients who had complex spinal fusion procedures. Reoperation rates were slightly lower than those reported in the SPORT study (4), with the researchers speculating that because the SPORT cohort was about 10 years younger, surgical risks were less. An accompanying editorial (5) to this paper by two surgeons blasted the study methodology in a thinly disguised rant at researchers who question the use of complex spinal fusion: “The attempt at ‘science’ by the pure use of statistics, as done in this paper, hopefully will not be our future.” A very recent study conducted by Kim et al (6), however, corroborates these findings, reporting a 14.2% reoperation rate for both fusion surgery patients and those receiving decompression alone at 5 years.

In summary, CMS pays a considerable sum of money for surgical interventions to decrease pain, improve neurogenic claudication, and other quality of life issues but for many patients outcomes are not satisfactory. The disturbing trend of increasing use of complex spinal fusion adds enormous cost for very little benefit.

In their Proposed Decision Memo, CMS characterizes this situation very differently: “Because there is no consensus diagnostic definition for LSS, there is a corresponding lack of consensus on treatment. ‘Given the considerable pathological and clinical heterogeneity of LSS, the lack of therapeutic recommendations and the large number of distinct therapies, the selection of an appropriate procedure is difficult.’ (Siebert et al. 2009) ‘Class I evidence-based recommendations cannot be made for any conservative or surgical therapy in relation to mid-term and long-term patient outcomes.’ (Siebert et al. 2009) In LSS patients without objective neurologic findings such as cauda equina syndrome, it is important to understand which patients will benefit from true structural decompression.” If this line of thinking was actually followed by CMS, no patients would ever be treated for their lumbar spinal stenosis complaints.

The surgical community has already presented its evidence for the outcomes of spinal surgery and these operations are expensive with many troubling issues, especially for complex arthrodesis. By continuing to approve payments for almost 40,000 of these types of operations every year for LSS patients, CMS continues to endorse the status quo, and disregards alternatives that could improve patient outcomes, reduce surgical complications, and lower re-operation rates at vastly lower cost.

The excellent safety profile and efficacy of the PILD procedure has been reported in sixteen peer-reviewed publications. The claim by CMS that “The case series for PILD did not report patient follow-up data” is puzzling and disturbing since nearly all reported case series reported follow-up data—many as long as one or two years (7-11).

I have been a long-time user of the PILD and have been committed to participating in studies, educating the medical industry, and battling insurance companies to get this procedure covered for my patients. Unlike more invasive surgeries such as surgical decompression and spinal fusion, the PILD is an outpatient procedure where no general anesthesia is required, the complication risks are extremely low, and the incision length is smaller than a baby aspirin, requiring no sutures. Reoperation rates at one year have been reported to be less than five percent. This procedure has been shown to be safe and effective in numerous high-quality, well-designed, prospective studies.

I respectfully ask CMS to provide a positive coverage decision for PILD.

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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 surgery.

Prior to MILD, I had only medication management (typically poorly tolerated in this elderly population), epidural injections (sucessful transiently in approximately 50% of patients and requiring repeated treatments with the risk of steroid overexposure), referral to open surgical decompression (high risk, difficult recovery for this population) or living with pain (unacceptable and inhumane).

It is important to note that MILD is performed on an outpatient basis with local anesthesia and minimal sedation. Most patients with lumbar spinal stenosis and neuroclaudication are elderly and have multiple comorbid conditions that make them relatively poor candidates for major surgery and required general anesthsia.

Furthermore, MILD is relatively inexpensive, costing about 10% of the cost of surgical decompression. If half the MILD cases represent successes, then the medical cost savings are tremendous.

In my practice, we take great care to ensure that the patient's pain is indeed neuroclaudicative in nature (pain with standing or walking, worse with extension) and that the patient's pain is no primarily mechanical (from discs or facets) or radicular (from nerve root irriation within a foramen). We only offer MILD in patients where the predominate pain in neuroclaudication and there is identifiable central canal stenosis with a component caused by ligamentum flavum hypertrophy.

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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 procedure fulfills a niche for patients with neurogenic claudication. I feel that the safety has been adequately demonstrated and that this is a comparatively cost effective treatment option.

Thank you.

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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, spinal injuries, blood transfusions), increased risk of death in the elderly population or conservative management with opioid medications. We are subjecting these patients now to choose possibly harmful and fatal surgeries or chronic dependence on opioids to try and function day to day - THIS IS WRONG. Would you want your aging mother and father or grandparents told their ONLY option is spinal fusion at the age of 70 or 80?

Why CMS cannot be sure that this procedure works, our patients can surely tell you that it does. They have had great results with longer periods of time walking and doing activities that before were very difficult to do.

Unfortunately, randomized control trials with this form of treatment would be quite difficult considering that alternative treatment carries with it greater risk (ie anesthetic and surgical risks). Patients woudl want to be in the less invasive group if they had a choice. The risk of the PILD is by far less and the recovery time shorter with improvement in pain symptoms and functional symptoms and still at the same time allows patients greater time to consider other for invasive surgeries down the road. If the patient receives a more invasive lumbar fusion, then they cannot have the PILD and therefore lose out on the ability to try an less painful and less invasive surgery to help them with their pain symptoms. The questions about adverse events is by far much less than more traditional back surgeries and with several studies indicating its great safety.

As with all new procedures, their needs to be greater time periods to utilze this new techonology before long term effects can be realized. I think this is very true for the PILD.

I hope you will reconsider your opinion on this procedure and its place in the treatment plan for physicians helping patients in pain, especially our elderly population. I have seen, as well as many o of my colleagues, the benefits of this procedure in pain relief.

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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 have several patients that are interested in this procedure, but unfortuetly reimbursement issues have restricted this service for the patient. I would like to see a change in this to continue to provide this service to patients in need.

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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 proposal.

Specifically, I would like to address the comments by CMS that adverse events associated with PILD have been underreported. Throughout the entire body of evidence, including 16 peer-reviewed articles, PILD has been shown to be safe with no reports of serious device or procedure-related complications. It is perplexing that CMS chose to focused on the following in the NCD draft instead of this large body of evidence:

“Several articles reported a good safety profile, however there have also been serious adverse events reported. Chopko (2011) reported two very serious post-op complications. Tumialan reported on 10 patients with persistent symptoms after the PILD procedure, including eight with refractory neurogenic claudication, two patients with cerebrospinal fluid leak, and one with a dural tear and transected nerve roots identified during revision surgery (Tumialan et al. 2012) He added that all of these patients required additional surgery with exploration. Although Levy and Deer reported on 373 patients, the data sources were unclear and we cannot be assured of consistent and reliable reporting when data collection methods are not reported in detail (Levy Deer 2012). We cannot exclude the duplication of subjects as well as lack of systematic adverse event collection, including failure to report serious complications arising post-op such as the ones in Chopko 2011. It is unclear why only a few studies reported adverse events of significance. With any invasive procedure, particularly in the complex area of the spinal cord with direct CSF and nerve connection to the brain, risk is not insignificant and should be realistically accessed and communicated to the patient.”

First, the two complications reported in my study were serious, but were not related to the PILD procedure. As indicated in the title of this peer-reviewed report, these patients were deemed to be at high risk for complications related to open spine surgery. Of 14 patients included in this pilot study, only two experienced complications, neither of which was directly related to the PILD devices or procedure. This level of safety is remarkable given the significant number of comorbidities suffered by this high-risk group of patients. Importantly and as reported, all patients had exhausted or refused further conventional conservative measures, and were not surgical candidates. These patients had no other decompressive options besides PILD.

Further, the referenced Tumialan report was a letter. It is missing much vital information and was not peer-reviewed. I find it strange that CMS would place credibility on a non-peer-reviewed letter by Tumialan and yet question the reliability of a peer-reviewed safety review of nearly 400 patients by Levy and Deer. In addition, CMS itself deemed the procedure safe enough to do in an ASC when it stated “… we agree with commenters that the procedures described by CPT code 0275T meets the criteria under § 416.166 and would be safely performed in the ASC setting and would not require overnight stays.” The conclusions in the NCA, therefore, seem highly inconsistent to me. Further, CMS appears to imply that authors did not report adverse events and that the reviewers of the publications allowed this to happen. This seems to be a very troubling assertion, especially for the Deer and Levy publication whose stated purpose was a “systematic safety review”. It appears that the NCA is calling into question the integrity of the articles themselves and the peer review process, which is a very serious allegation.

Regarding efficacy in our study, these high-risk surgery patients experienced a significant improvement in pain as measured by VAS, but ODI change was not statistically significant. The lack of ODI improvement the NCA pointed out was not surprising and we addressed this issue in the Discussion section of the publication: “The lack of improvement in ODI scores is not surprising, given the fact that many of the patients had physiologically limiting coexistent issues, such as oxygen-dependent pulmonary fibrosis, prior stroke, and systemic malignancies.” For this patient population, we were very pleased to significantly reduce their high level of pain.

In addition to a better safety profile with equivalent efficacy, the PILD procedure offers a lower cost alternative than surgery with significantly shorter facility stays, less anesthesia and shorter patient recovery times. Having treated over 100 patients with PILD, I strongly encourage CMS to offer coverage of PILD to the elderly Medicare population.

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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 extremely disappointed to read CMS’s non-coverage proposal for the mild procedure. It seems astonishing to me that CMS would come to this decision given the wide breadth of peer reviewed publications on mild, the potential benefits to the health care system, and the large number of treating physicians expressing support for the therapy.

As I mentioned in my comment on 4/28/13, I have done around 80 of these procedures and conservatively estimate that 80+% of MILD patients in our practice experience relief.

There are several items in the NCA proposal that I find to be at sharp odds with the practice of interventional pain medicine. The first has to do with the NCA’s desire to get long term data from “robust randomized sham controlled clinical trials”. Pain medicine, at its core, is about easing the suffering of our patients who experience symptoms of pain. The idea of conducting a long term study where the control group gets no treatment at all (i.e. a “sham”) seems greatly at odds with the mission of our specialty. Trying to conduct a study on pain patients where no palliative or therapeutic treatment is provided to a control group for an extended period of time is destined for failure. Even published trials where the control group received an alternative treatment were difficult to conduct over long periods of time. This is evidenced in the Brown trial (where 100% of patients crossed over to mild when given the opportunity) as well as the SPORT trial where 437 out of 1091 eligible patients refused to participate in the study, 365 patients refused to be randomized, 42% of patients assigned to the nonsurgical treatment arm of the randomized cohort underwent surgery at 1 year, and only 63% of the surgical treatment arm of the randomized cohort had underwent surgery at 1 year. It is very clear that it is extremely difficult to randomize and control patients in pain studies and even more so when you are asking them to enroll in a long term study where no pain therapy (i.e. “sham”) is an arm of the study that they can be randomized into. Who would sign up for a study where they could possibly get no treatment for a year or more? No one. The CMS recommendation on study design is just impractical for pain treatments.

The NCA’s contention that LSS is difficult to diagnose and, therefore, mild should not be covered is extremely perplexing. When we look at using mild we actually have a very specific process for selecting patients. We don’t just look for “LSS” or “back pain patients”. We look for patients that have trouble standing/walking, who experience back/leg numbness/pain when they try to stand/walk for long periods, whose symptoms are relieved when bending forward or sitting, and who have a hypertrophic ligamentum flavum as the main contributor to their stenosis. This therapy actually has very specific patient selection criteria. This is not something that we offer to anyone that has “back pain”. Secondly, the fact that the NCA uses the perceived difficulty of diagnosing LSS as a justification for non-coverage of mild while at the same time extending coverage to other treatments such as surgery is completely inconsistent; especially when these treatments use more healthcare resources and have higher risk profiles.

In summary, I’m very disappointed that CMS did not consider the clinical experiences of interventional pain physicians such as me. If CMS had done so, it would have recognized that its justifications for non-coverage are at odds with the practice and practicalities of interventional pain medicine. This therapy fits an important unmet need between conservative treatments and surgery…especially for patients who need a decompression but aren’t good surgical candidates.

I urge you to reconsider.

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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 spine can be reduced significantly to displace and compress the spinal cord or roots. Disc protrusion, facet hypertrophy, and ligamentous hypertrophy are generally present. While many conditions can lead to low back pain, spinal stenosis symptoms are generally somewhat more unique. Inability to stand erect, and difficulty walking due to progressive leg weakness and pain, in the presence of anatomical stenosis represents the syndrome of the specific back and lower extremity pain.

#2 , a lack of consensus on treatment of spinal stenosis and existence of other treatments. Until recently, it has been a well accepted practice to exhaust nonsurgical treatment options, such as epidural steroid injections, physical therapy, and various medication to palliate the symptoms. is well accepted that conservative management has demonstrated quite dismal statistics for long-term management of severe spinal stenosis. Anatomically, decompression of the stenosis through laminectomies has apparently been widely accepted as therapy for patient who fail conservative measures. Unfortunately, in the elderly and frail, surgery may be contraindicated due to risk. Often, these patients are left with no hope of adequate pain control. With the advent of a percutaneous approach (MILD) that does not require incision, muscle and bone dissection, many of these people do have hope of pain reduction with considerably less risk. Several clinical studies published to date document the effectiveness of the MILD procedure in patients with specific types of spinal stenosis. It is a consensus among physicians who perform MILD procedures that a significant amount of the stenosis is caused by ligamentous hypertrophy, rather than disc or facet mediated spinal compression.

#3, since this is a relatively new procedure, long-term data is being collected as patients progress through the therapy. How can one expect long-term data when such data is only now accruing since the advent of the procedure. This same argument could be used on newer medications that have been only recently passed by the FDA.

#4 Due to the nature of the procedure,as well as the significant number of patients who have already undergone the procedure, the nature of potential adverse events has been addressed, and found to be minimal. This is why it is safer for the elderly and frail patients who are not candidates for the higher risk of complications of seen in laminectomies.

#5 The placebo effect can play the same role in patients undergoing laminectomies or any other treatment approach for spinal stenosis. It would be extremely difficult to do randomized, double blind-placebo-controlled studies on surgical procedures. The same argument could be made for parachutes.

#6 Removal of hypertrophied ligamentous material from the spinal canal would be expected to reduce mass with in the cross section of that canal to allow expansion of thereserved for neural contents. If an epidurogram documents such increased space, and improved flow through the spinal canal, there appears to be that correlation that would suggest significant reduction in nerve root compression. A laminectomy is no guarantee of effective, of addressing all aspects of spinal stenosis either. Additionally, in those patient felt to be too ill for surgical decompression, there are no other options to reduce the pressure/compression on the spinal contents.

In summary, ongoing studies do document the benefits of this newer form of therapy that can be used on those patients who are not candidates for the more aggressive surgical procedures. I have had many patients in my own practice would have been turned down for open surgical laminectomies, who has had significant benefit with pain reduction, mobility, and quality of life as a result of the MILD procedure. If this procedure would be discontinued, the elderly and frail would be the most impacted because they would have no other options for therapy. Moreover, They are also the most likely to have that specific type of spinal stenosis that arises primarily from ligamentous hypertrophy. I urge you to consider the importance of effective and less invasive therapies for this major community health problem.

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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 injections, laminectomies, or fusions, we decided to add MILD to our paradigm of care. The surgeons/ interventionalists and medical providers agreedthat MILD is a safe procedure with good long-term (2 year) efficacy data, and it made sense to incorporate it. At my center, we monitor all of our outcomes (SF36, EQ5D, standing/walking tolerance), including baseline, 1, 3, and 6 month data-points on all patients undergoing MILD. Surgeons who feel that patients are not candidates or don’t need/want more invasive decompressive laminectomies for lumbar spinal stenosis (LSS), refer patients to me for MILD.

I have been performing the minimally invasive lumbar decompression (MILD) procedure for approximately 6 months. A total of 12 patients have been treated, with 8 demonstrating significant clinical and functional improvement. These patients were carefully selected and all had MRIs which showed significant central canal narrowing based on thickening of the ligamentum flavum, in conjunction with clinical symptoms consistent with neurogenic claudication from LSS.

This subgroup of patients had failed comprehensive and conservative management options including epidural steroid injections, medication management, and physical therapy. These patients did not pursue more invasive surgical decompression for stenosis because of patient preference for less invasive and less risky options, such as MILD, or based upon careful consideration of medical comorbidities, age, and associated risk factors. All patients had realistic goals of improved walking and standing tolerance after MILD.

I disagree with the commentary suggesting that there is no clinical consensus on the diagnosis of LSS, as this is one of the most common and frequently diagnosed conditions seen by back specialists. There are clear radiographic signs such as canal diameter and clinical symptoms consistent with neurogenic claudication. Common treatment paradigm is well accepted and includes trial of conservative measures such as medication management, exercise through physical therapy, epidural steroid injections, alternative approaches, and once these fail to give sustained improvement in pain control and functional capacity, consideration of decompressive laminectomy. MILD offers patients a new option when conservative measures fail. It does not preclude patients from undergoing decompressive laminectomy at some point in the future if needed.

My experience thus far suggests that the MILD procedure can lead to significant reduction of neurogenic claudication symptoms, reduced requirement for adjuvant and opioid medications, reduced need for epidural injections, improved functional capacity as measured by walking and standing tolerance, and improved patient satisfaction. Minimally invasive options are and will continue to be important for patients as well as the healthcare industry and MILD should remain an option for patients with LSS.

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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 be statistically significant at 80% recovery of their activities of daily living. What I do not understand is the lack of attention or credit given to the large Physician base who report these overwhelming favorable outcomes.

CMS states there is no “gold standard” for treatment of spinal stenosis, and no defined conservative treatment for this condition. In treating spinal stenosis it is important to identify the subset of the patient’s condition. Hypertrophic Ligamentum Flavum is a subset of spinal stenosis and when identified can be treated by the mild procedure in an effort to alleviate symptomatic pain and restoring activities of daily living. Identifying a “gold standard” for spinal stenosis would be difficult as each patient’s condition varies. Conservative treatment algorithms vary per patient as well. They are best identified by the treating Physician and the patient’s tolerance to treatment. Common practice begins with NSAID’S/Pain Management, Physical Therapy, and Steroid Injections. Other treatment options cold include back bracing, TENS units, Chiropractic treatment and HEP.

Having read CMS statement and its strict assessment, I question why there is no National Coverage Decision for Spinal Fusion, a more invasive, costly, covered benefit be Medicare. In an article written by the Washington Post “Spinal fusions serve as case study for debate over when certain surgeries are necessary” Richard Deyo a researcher at Oregon Health and Science University was quoted that “my hunch is that as many as half of the spine fusions in the U.S. are unnecessary” It was also reported that lumbar fusions to treat stenosis rose the fastest from 292 in the year 2000 to 2,565 in 2012. Several patients interviewed in this article interviewed reported they were advised they would be “crippled” should they not have spinal fusion. One patient suffered from Carpel Tunnel Syndrome. When she sought outside treatment from another Physician an $18.00 wrist brace relieved her symptoms. The only coverage determination found was located in Florida which set minimal criteria for spinal fusion (to include the diagnosis of spinal stenosis) of conservative treatment of three months. I can report that the treatment algorithm for my patients identified for mild procedure exceed more than three months of conservative treatment before I consider a minimally invasive option, let alone a significant invasive open procedure.

Additionally, your CMS Integrity Manual clearly defines when creating a coverage determination, that less stringent evidence is needed when comparing a procedure that is less costly that a currently covered procedure – e.g. Mild vs. Open decompression.

In an article written by Bernard Lo and Marilyn J. Field, Editors; “Committee on Conflict of Interest in Medical Research, Education, and Practice; Institute of Medicine’ the author states “Relationships between physicians and biomedical researchers on the one hand and pharmaceutical, medical device, and biotechnology companies on the other hand are widespread and have produced important benefits, particularly in the development of new tests and treatments. At the same time, these relationships have also created significant risks that the financial goals of industry may conflict with the professional goals of medicine. The goals of for-profit medical companies are to produce products that improve health and, at the same time, to ensure a financial return to shareholders. The primary goals of medicine include improving health by providing beneficial care to patients, conducting valid research, and offering excellent medical education. In pursuing those goals, individual professionals, health care institutions, and research organizations have obligations to put patient interests first, carry out unbiased research, critically appraise information, and serve as role models of professional behavior for students.” This article identifies possible motives that present conflict of interests, however should you review the clinical data you would see that advancement of outcomes from the earlier articles that suggest certainly further trials are necessary to the most recent articles that prove the efficacy of the this procedure. I highly question the intention to suggest these well-educated, honored, and trained published authors would consider anything other than their patients’ best interest as their primary focus. This is my primary focus as I treat each of my patients.

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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 treatment of Spinal Stenosis and the existance of other treatment options, not every patient responds to the treatments currently available. PILD was developed to treat a patient population not currently or effectively served by the currently available treatment options.
CMS also raised questions about adverse effects of this treatment. Many PILD procedures have been performed over the last several years; data does not demonstrate frequent, severe adverse effects. Any interventional procedure, whether for the treatment of pain or any medical condition, carries risk; yet we are not seeing concerning rates of adverse events with this procedure.

Please reconsider providing coverage for Percutaneous Image-guided Lumbar Decompression.

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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 patients. I have performed 27; and, 23 of them have had exceptional improvement in pain score and functional outcome. For example, one individual was able to walk less than 10 steps prior to procedure; but, able to walk great than a mile on a daily basis now. Mine you, this patient is "an ideal candidate for a 4-level anterior-posterior laminectomies, foraminotomies, interbody cages fusion. The case would have cost upwards of $250,000 to Medicare. This example is NOT an isolated case; rather, it is the NORM for those 27 cases that I have performed.

This move by Medicare is obviously political, and, NOT evidence-based. To say that modalities, ie, open surgeries already exist; therefore, the MILD is not a necessary modality is preposterous. Nothing against the spine surgeons and neurosurgeons, but, what have the outcomes of those back surgeries? At best, they have been fair to mediocre! In fact, as a fellowship trained interventional pain specialist, I see lots of failed back surgical syndromes. My waiting room is full of them! For a modality that purportedly has "insufficient" evidence, my patients are getting better. So, I don't know what evidences CMS are using.

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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 of cases be excluded. Furthermore, lumbar stenosis has a very characteristic clinical presentation of limitation in standing and walking.

Present treatments do not address the full needs of elderly patients with spinal stenosis. Medications, physcial therapy and epidural steroid injections help a fraction of patients. Similarly only a fraction of patients qualify for surgery based on age and co-existing disease. That said, many elderly patients take a risk with open surgery and suffer both short-term and long-term complications. This fact drives up costs. Minimally invasive options such as percutaneous lumbar decompression help another fraction of patients that are too sick for surgery but a the same time do not benefit from any other mode of therapy.

Long-term follow up on the MILD suggest durable benefits up to two years. Most of the data on open surgery or epidural injections only follow patients out to one year. The MILD has proven safe so far with very few adverse events reports.

We have begun a MILD program this year and have been impressed with the results thus far. When patients have failed multiple treatments and improve with the MILD, it is hard to believe that a placebo is working here. Walking distances and standing times are markedly improved. The MILD goes beyond a pain treatment, it is a functional treatment. A small amount of tissue removal that decompresses the canal has an amplfied effect as the resistance is related to the radius to the 4th power. The MILD has the added benefit of preserving the back muscles over open procedues. This allows for functional rehabilitation and preservation of lumbar lordosis which is necessary for optimal posture. In summary, the MILD has been used for only a brief period of time compared to other treatments, but has gained evidence favoring it's effecitveness. Other nations have embraced the technology such as India. I am fearful that the US will be stuck with open surgey while developing countries will haved advanced to minimally invasive options. This is the case already for thermal discal treatments.

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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 hospitalization and risks involved with blood loss and associated risks of going through general anesthesia certainly do not justify the patient going through laminotomy and laminectomy when a minimally invasive procedure can do the same benefit with far less risk and morbidity for the patient.

When I heard that the coverage is going to be discontinued for such a good procedure I am terribly saddened and shocked by the news.
100 % of the patients that had the surgery done by me have had their pain go away and their functional capacity increase 3-400 %
I dont what other procedure is out there that can have such an effect with so little expense.

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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 get they still return for more procedures. As a 4-6 weeks releive of pain for some patients is a live time of relief, beside they maintain their independence. Now So far the same patients are now been refer for mild procedure and they inital comment is that they didn ot remember the time that they were pain free and able to move around the grocery store w/o the need to stop every 10 steps or so. Also those who maintain the medications seems to have their does decreased. A good example is a patient who works full time as a sale person driving more than 500milles aweek and in pain all the time. Huusband and wife both agree that since the procedure their live ais much better as he comes home in a better mood and able to do more making their time much better.

Furthermore, one of the questions is that we do not know how often we would be repeating this procedure if need be? My coment in relation to this is that we perform epidurals year after year w/o any evidence of affecting the natural history of the condition, here we have a change to do just that with minimal conflict in relation to the patient well being. Considering the side effects of steroids when done for many years, like osteoporosis, I beleive that instead of hanging this procedure we should embrace it. If this means making protocols to protect the path and to keep the procedure to those who really need it well let it be done. I beleived that the algorythms are in fact needed in the feel of medicine so we can replicate outcomes and improve quality of life for our patients.

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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 less chance of problems. The tools remain posterior to the epidural space!

The placebo effect is a significant risk, particularly for interventional pain procedures: my personal experience is that function including distance of walking has improved. I do not solely look at pain scores to judge the outcome of any procedure. And I would rather have a patient experience the placebo effect from the MILD versus rampant narcotic use.

CMS has to support this procedure as well as others; otherwise, the nation will towards becoming prescription drug addicts, which is not the goal of pain medicine. Compared to so many other procedures, this carries far less risk. Restrict the procedures to only ACGME trained individuals if necessary and worried about overuse.

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[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 costs down and helps patients immensely. This is the kind of stuff you want more of, not more surgery.

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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 evidence, and I am aware of the limitations of such evidence, nevertheless, it cannot be ignored that patients with neurogenic claudication caused by lumbar spinal stenosis with ligamentum flavum hypertrophy, for whom I have performed the MILD procedure have had universal excellent results with resolution of their symptoms of claudication and significant improvement in their functional capacity.

I agree that there is a lack of diagnostic criteria for lumbar spinal stenosis (LSS) but if the clinician evaluates a patient with classic symptoms of neurogenic claudication in the lower extremities that is exacerbated by walking and relieved with rest and lumbar flexion, and whose MRI study shows findings of central canal stenosis with trefoil shaped central canal, anterior clustering of the nerve roots, and ligamentum flavum hypertrophy, the physician should include the MILD procedure in the medical armamentarium for treatment of the patient. Alternatives to MILD include medical management of the patient's somatic and neuropathic pain, oral antiinlammatory regimens or epidural corticosteroid injection. These measure do not address the nerve root ischemia that is known to occur when the pressure within the spinal canal exceeds capillary pressure. Surgical decompression is currently available to patients with LSS, but at significantly greater cost and morbidity than the MILD procedure.

PILD, or MILD, is an indispensable part of appropriate conservative care of patient with LSS. The procedure effectively ameliorates neurogenic claudication and improves function and quality of life in patients with ligamentum flavum thickening, and this de-bulking of the thickened ligament can readily be demonstrated with pre and post procedure epidurogram or MRI scan. It is imperative that patients continue to have access to this important treatment option.

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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 are multiple discrepancies in the surgical management of LSS without convincing evidence that one is better than the other. And yet they are generally approved by CMS. As opposed to a non-coverage determination, it would seem to make much more sense to allow for a period of further review. This procedure has provided excellent pain and functional improvements to patients who are not candidates for surgery due to other medical issues, or not interested in surgery due to the hospital stay and prolonged recovery required. Medicare recipients should be allowed to make their own decisions in terms of their management of LSS. Without this procedure we are limiting patients to either going for conservative management, which has minimal long term benefits, or open surgery that is invasive, has a higher complication rate, is more expensive, and places a higher burden of medical care both in the hospital and patient/family post-operatively. A head to head comparison, as recommended by the reviewers, would be an excellent idea, but will never happen without ongoing CMS coverage. It does not seem to make sense that CMS role in this is to limit coverage. Instead it would make sense that CMS would be more concerned with protection of patients. There are at least 3 studies sited to attest to the immediate safety of the procedure. CMS covering an additional treatment option for LSS that is dramatically less invasive and inherently safer to provide patients with an additional choice for management of a debilitating and progressive problem seems like common sense. Limiting coverage because we do not have perfectly designed studies in a randomized, controlled fashion does not makes sense. I would hope to be able to continue to offer this procedure to my LSS patients with quality of life limiting neurogenic claudication.

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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 anesthesia.There has not been one complication.

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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 for an elderly patient with severe spinal stenosis causing significant impairment of their functional ability manifested as either wheelchair and bed existence and at best, walker and wheelchair activity. These restrictions impose rather severe cuts in these patients quality of life. They may be 709 or 80 or even 90 years old; but they are still very functional human beings.

When these patients come to us with severe claudication of less than a city block or worse; cant stand or walk any distance without having to sit down, an MRI scan identifies if there is a stenosis and the anatomic pathologic cause of the stenosis. A selective nerve root injection will then verify IF the stenosis seen on the MRI is causing the patient their pain. If not, there i little reason to pursue the stenosis. If it does relieve the pain, then the diagnosis is secure and efforts at decompressing this stenosis is therapeutically assured.

Of the three things that can cause a spinal stenosis, often it is the degeneration and resultant thickening of the ligamentum flavum causing the compression of the nerve roots. If most of the patient's stenosis is from this thickening, their therapeutic options include:

1. wheelchairs and walkers
2. formal decompression with resection of lamina and facet joints requiring orthopedic stabilization and fusion
3. MILD

Since most of these patients are elderly and have concominant health problems that would increase their morbidity and mortality of these surgical procedures, ANY minimally invasive procedure to help relieve their pain is a God send.

The minimally invasive lumbar decompression is just that type or therapy that has shown itself to be very helpful in allowing these patients to be much more functional with considerably less pain. Its morbidity to date has proven itself to be very minimal allowing for outpatient application and very little recovery time and discomfort. Considering their alternatives, the MILD procedure is an easy decision.

I have been performing these procedures for only 6 months (16 to date) and 12 of these have had marked improvement of their ability to walk and stand allowing them to be more independent and not have to resort to mind altering narcotics. Of those who did not respond, all were happy they did it and felt they had some response that was favorable. There were no complications and all went home an hour after the procedure.

For a practitioner whose job and mission it is to get these poor folks through day by day, this is a therapeutic option that really plugs that hole in what we can do for these elderly patients.

We really need all the help we can in helping these patients.PLEASE, do not restrict us from using this great technique. With all the cutbacks, pain physicians are left with bandaids and aspirin to relieve all this suffering out there; dont take another modality away from us again!!

Thomas G Johans,MD

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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 option greatly benefitted from this low risk, minimally invasive technique.

It will be a disservice to the US population to not allow this procedure to continue its evolution and to not allow us to continue to study this technique.

I agree that perhaps some guidelines should be in place for appropriate pre-approval such as failure of physical therapy, NSAIDs (if applicable) and confirmatory imaging of spinal stenosis.

Additionally it would be difficult to have non-industry sponsored studies if the procedure was not convered by CMS. How can independent physicians study a procedure that will not be covered for re-imbursement?

I understand CMS frustration with the lack of consensus for diagnosis and treatment of lumbar spinal stenosis. This arrises from the fact LSS is related to a condition thats primary manifestation is pain. However similar arthritic conditions are accepted by CMC without stringent diagnostic guidelines. i.e.: degenerative arthritis of the KNEE and HIP have no definitive diagnostic criteria other than imaging criteria. Nor is there any strict accepted guidelines for TKA/THA. Orthopaedic surgeons understand that although imaging findings may be severe, the clinical condition does not always manifest, therefor we have to put a constellation of parameters together to obtain a diagnosis.

Not all things in medicine can be firmly defined, this is were the art of medicine comes in play. Spinal stenosis with neurogenic claudication encompasses a variety of symptoms that need to be verified by exam and imaging as the most plausible cause of patients symptoms. As well as ruling out other causitive factors.

Please contact me should you have any other questions regarding my comments.

Sincerely

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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 following the procedure. The medical studies also show the procedure to be durable.

PILD is for patients with symptomatic spinal stenosis. They must meet radiological and clinical criteria. I do not believe there is a lack of consensus on the diagnosis of spinal stenosis.

This is a procedure which is performed as an out-patient with IV sedation. It does not require a general anesthetic. My patients have tolerated the procedure very well. There is virtually no recovery time. I see a lot of patients with spinal stenosis both elderly and not so elderly. This is condition which takes a terrible toll on the patient’s ability to take care of themselves and to have a good quality of life. It takes away their mobility and as they ambulate less, their overall health deteriorates. Their options are usually severely limited. Their options include an open decompression which has a much higher complication rate, a long recovery period and may have a poor outcome. Many of my patients are simply not in good enough health to undergo such a procedure. I have not personally seen any complication arising from the PILD procedure. I have on the other hand seen the unfortunate adverse sequel from open decompressions.

As for many complex medical issues, there are a number of possible treatments and opinions as to which treatments are the best. I believe the most effective treatments that are the least invasive are the in the best interest of my patients. PILD fills this need.

For some, a spinal cord stimulator may be an option. This requires the patient to be able to use the device and maintain it. This is a very expensive option for them. The PILD procedure fills the treatment gap in the algorithm for the treatment of lumbar spinal stenosis.

While the placebo response can confound studies on pain procedures, I don’t believe my elderly population is very susceptible to it on a long term basis. I do not believe the long term benefits I have seen with the PILD procedure can be written off as a placebo response. It is hard to imagine that someone who could only stand 2-3 minutes and walk a few feet, who can now walk a mile and stand for 45 minutes, is experiencing a placebo response.

Radiological studies poorly predict pain. The correlation between what we see on X-ray, MRI, CT or Myelogram and a person’s pain do not correlate well. To say that it should is to ignore the reality of the current understanding of pain mechanisms. Spine surgeons operate daily on patients with abnormal anatomy to make their anatomy “look better.” Unfortunately, we see patients everyday who are still in pain, but who have “normal alignment” and “good placement of hardware.”

There are many published, peer reviewed articles which show the PILD procedure to be both safe and effective. They have shown the PILD procedure to have long term efficacy. Most have used such measures as the Oswestry Disability Index, Visual Analog Scales, and the Zurich Claudication Questionnaire. While I believe these measures are very important, the two measures that have the most meaning to my patients are how long they can stand and how far they can walk. It is very gratifying to treat a patient that can stand for only a few minutes or walk only a few feet without extreme pain and get them back to functioning where they can stand and prepare their meals and walk through the grocery. This greatly enhances their quality of life.

There have already been several comments by qualified experts concerning the details of the procedure as well as the available literature on the PILD procedure. I will not belabor the point here. I strongly suggest a positive National Coverage Determination for PILD so that patients who suffer with spinal stenosis may have a safe, effective, and minimally invasive treatment option.

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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. Non surgical options some times work and sometimes they do not. In between these modalities, the MILD procedure exists.

After having performed about 30 cases of the mild, about 20 patients had received more than 50% benefit and avoided risky surgery. About 5 had received some benefit (less than 50%) and about 5 no benefit. The evidence is there. The procedure works for the right patient candidate.

The procedure is much safer than surgery. I have not had any complications. The patients go home the same day and resume normal activities the following day.

The spinal canal is a very small space normally. When we are able to remove just a few mm's of calcified ligamentum flavum, the patient may notice significant relief.

My neurosurgeon colleaques have noticed their patients improving with this procedure. Recently, I had performed the mild procedure on one of their aunts- 100% pain relief the next day.

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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 comparable treatment. The Institute of Medicine stated that "relieiving pain should be a national priority". Presently, the options include medications, epidural steroid injections or surgery. In elderly patients, all of these procedures carry significant risks that must be weighed against potential benefit. In the vast majority of cases percutaneous lumbar decompression has a favorable risk to benefit profile compared to any of these options.

The current default in most cases of neurogenic claudication is medication management. The cost of medication management is increased falls with fracture secondary to opioids and centrally acting medications, gastrointestinal bleeds secondary to non-steroidal anti-inflammatory medications and hospital admissions and occasionally surgery for severe constipation secondary to opioids. Each of these issues is very costly to the patient and to the system. These costs are not currently captured but they do exist. Percutaneous lumbar decompression is a tool that pain medicine physicians could use to improve patient health and decrease adverse outcomes.

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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 is a pretty accurate estimate in our patient populations as well. This is the perfect option for those thousands of patients who have symptoms associated with LSS but are not a surgical candidate (i.e. either because of lack of stenosis that warrents a decompression or those too ill for a spinal surgery). This procedure fill a necessary void for back and leg pain.

I hope that determination for eliminating this treatment modality is quickly reversed. It would be a terrible waste to eliminate such a safe and effective treatment option!!!!!

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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 other treatments. If other treatments exist and are approved by CMS, than the LSS is a real problem and one cannot deny it's existence due to supposed lack of diagnostic criteria. Mere existence of other treatment modalities does not preclude the fact that a new, superior treatment is a viable and good alternative. Following that mentality coronary angioplasty would have never gotten hold as an alternative treatment to coronary artery bypass graft for the ischemic heart disease. With regards to the durability of the procedure, it's been performed for about 3 years now and there have not been any cases reported of a need to have the procedure reported.The procedure has excellent safety track record, vastly superior to the open surgery alternatives.

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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 specialists.

In brief, there are patients with debilitating lumbar spinal stenosis that for specific reasons are not surgical candidates. They need a treatment for relieving the stenosis and thus their back and leg pain with accompanying weakness (neurogenic claudication). When the stenosis is caused by ligamentum flavium hypertrophy, a debulking procedure such as MILD (minimally invasive lumbar decompression) absolutely makes sense. There is the possibility for inappropriate patient selection, but when thoughtfully and carefully applied, PILD/MILD procedures can be immediately and immensely successful at relieving pain and restoring functionality to an otherwise debilitated large population of patients.

Please consider keeping and supporting this as a treatment option.

Thank you.

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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 morbidity.

The MILD procedure has a significant efficacy for extended duration of time, as evidenced by patient's I've treated so far.

There is NO placebo effect - when a patient comes back a week later and tells me that they were able to go out and walk all over the mall, where as prior to the procedure, they could barely walk from the car to the office.... that is NOT placebo.

The mechanism of action is decompressing the spine at the critical part of the curve where the stenotic effect occurs. Not only do we see radiographic evidence but we see obvious tissue removal.

This is one of the most effective procedure for our medicare population.

This procedure should be available to our seniors.

james rho, md

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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 minutes resolves the pain and weakness. These patients are often elderly with multiple medical issues that make surgery in the form of laminectomy in the simplest occasion with some risk, not only for surgery but general anesthesia. The PILD procedure is done with only local anesthesia and minimal sedation as an outpatient procedure. The results in part depend on experience but have been good and will likely improve with more experienced physicians. It is much safer than for laminectomy.

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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 measures such as medication, PT, and injections, what then is their option? Currently, these patients are offered open decompression and/or fusion at a high level of risk, costs, and it is well known that adjacent level disease/failure occurs in many patients requiring reoperation accumulating greater risk and cost.

Stating that outcomes should be correlated with radiographic findings is not valid. Functional outcomes tracked on intervals and showing progress is a very strong correlation to success and pild has been shown to do so with regards to standing time and walking distance.

As with any new procedure, studies are initially funded by the parent company. At least the company spent the time and effort to fund trials.

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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 results exceed those of laminectomy at 90% for approximately 3 years. The long-term results patients have experienced have been durable, including in my practice also. There is clear diagnostic criteria for LSS and MILD candidates with 3mm of HLF and a positive response to epidural injections. MILD does not treat "back pain" but it treats symptoms of neurogenic claudication in patients that respond to epidural injections, so these patients are easily defined. The pain in this condition goes into the legs with ambulation and is very specific and also easy to define in spinal stenosis patients. LSS with neurogenic claudication responds to decompression. Laminectomies and nonsurgical treatment options already exist to treat the condition, and MILD offers a minimally invasive technique to spare some patients the morbidity and mortality associated with more invasive procedures and associated adjacent segment disease and spinal instability that accompanies laminectomies. 90% of my patients that have had MILD have had relief of their neurogneic cluadication that has lasted more than 3 years. My complicaton rate is extremely low. The placebo effect is a significant risk,in all of medicine and is not specific for minimally invasive surgical procedures or interventional pain procedures.There are no blind, randomized, controlled studies of the alternatives to MILD including laminectomy, so to with hold treatment upon this basis is a disservice to the patients that Medicare insures. There is a cleat mechanism of action with removal of laminar bone and hypertrophied ligamentum flavum to reduce spinal stenosis. There are many studies that show the effectiveness of epidural steroid injections which help improve neurogenic claudication and in my hands patients require many less epidural injections for neurogneic claudication following MILD.

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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 procedure, and no patients suffered any complications from the procedure. The remaining 10 patients were very much improved, in terms of VAS scores, levels of activity, and reduction in use of medication. This effect has persisted to date in 9 of the patients. Although there is no accounting for placebo effect in my personal series, one of the patients has severe Alzheimer's disease, and was unable to walk prior to the procedure, without significant complaint and disability. After the procedure, she had no memory of having had any difficulties with ambulation, and the pain behavior stopped. I do not believe that this could be a placebo effect in this particular patient since she has no memory of the procedure.

I am aware that CMS prefers evidence-driven data in making decisions regarding approving a particular treatment/device. The problem with having a strict definition for LSS and for ligamentum flavum hypertrophy, is that there is so much individual variation in anatomy and symptomatology that strict definitions may have no meaning in this case. This same conundrum applies to other spinal pathologies, such as neural foraminal stenosis, degenerated and herniated discs, sacroiliac joint disease, etc. However, there are numerous approved procedures which we perform for these diagnoses. Clinical judgment, patient presentation, and patient preference need to be the driving decision-makers when it comes to choosing a therapy. In my limited series of patients I have treated, I feel that my success has been at least as good as the patients who undergo open procedures, and the recovery time and complications are superior. My patients and I would hate to see this taken away as a viable choice.

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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 symptoms. Majority of the patients, about 75-80%, have reported greater than 50% pain reduction and improvement on their functional status, and enhanced their quality of life.

The long term outcome study while is still not conclusive, it is certainly very promising and superior to epidural steroid injection and close to corrective surgery without the high risk associated with the surgery when it is performed by a qualified trained interventional pain specialist.

I urge the committee to vote in support of this latest advancement in medical technology that will help millions of Americans suffering from neurogenic claudication.

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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 two years of my practice our group has employed an orthopedic spine surgeon. Now most of our patients receive open decompression. In cases where patients are not considered healthy enough to receive general anesthesia or do not want open decompression I perform the MILD procedure.

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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 components (disc bulge,facet joint hypertrophy & ligament hypertrophic calcification) and all 3 components have to be addressed by open decompression for patient to get symptom & functional improvement.It is time to reconsider this age old concept just like we changed our thinking on hard wired CNS.

One & two year outcome studies have shown that the functional improvement seen at 2 weeks post procedure is maintained at 2 years.

Adverse effects in properly trained hands have beemn minimal.

70-75 % successful outcome as shown in most well conducted trials & studies canot be attributed to placebo effect.A patient who cannot walk more than a block cannot maintain walking through 9-18 holes of golf game !!

As stated above,we need to challenge the age old concept about LSS.This procedure has shown that decompressing the ligament component can result in improvement of stenotic symptoms.

Finally:

At the present time there are no non open surgical options to treat LSS in classic neurogenic claudication,MILD fills this void.It has several advantages over open surgical decompression.

1. It is performed in outpatient settings with minimal sedation.
2. Patients are ready to resume work in 1-2 weeks.
3. Minimal complications.
4. Lumbar architecture is preserved.
5. The beneficial effects are maintained at 2 years according to a major study.
6. Does not preclude open surgery should the procedure fail to improve patient's symptoms .

In summary I can see every reason our senior citizens who may be poor surgical risks have a chance to improve their quality of life,ability to stay active,improve fitness & diminish their risk for heart/lung problems.

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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, and should be adhered to. They are clear and not ambiguous: no spondylolisthesis, LSS should be from the hyperthrophied LF mostly, and symptoms should be neurogenic claudication more than low back pain. This is after they have failed ESI's and more conservative measures.

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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 anesthesia. Many of these patients have been denied surgical therapy for these reasons. The published risks for complications from conventional surgical therapy in this grou[p of patients approaches 25%. The MILD procedure has been shown to have less than 1% complication rate in the same patient cohort. In my experience, greater than 80% of the patients who have undergone MILD in my practice have had dramatic improvement in their ability to stand and walk without pain.

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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 radiographic imaging.

It is very clear when discussing symptoms and imaging findings with patients what is going on. The treatment for LSS, also pretty clear in my opinion, has been epidurals, with mixed results, and laminectomy. Laminectomies do help, but sometimes patients have continued pain and some patients with significant comorbidities or fear of surgery cannot get the treatment they need. The percutaneous lumbar decompression fills this gap of treatment for these patients who need it. There are several long-term studies demonstrating efficacy over a 2 year period for the percutaneous lumbar decompression and this is very encouraging. Two years is a good indication of response to treatment and I think shows this treatment is effective. There are some mild adverse events reported with the decompression procedure, but I have not encountered these.

Any procedure is going to have risks, but these are minimized with the percutaneous decompression, especially when you compare them with open surgery. Placebo effects are seen with some pain management procedures, but placebo effects are not of long duration and exist across the board, including traditional laminectomies and medications. I don't think this accounts for documented improvement over a 2 year span as reported in the literature for the percutaneous decompression procedure. The mechanism of action is very clear in the percutaneous decompression and easily visible while performing the procedure itself.

The epidurogram becomes a full column after decompression and it is very easy to see that the ligament or bone that was causing the stenosis, also seen on the epidurogram, has been removed. Location is very important in this procedure and a small bit of ligament obstructing the nerves can have a very big clinical effect. I think this is grossly underestimated by most clinicians but from my experience and my patients' experiences, they have benefited from this procedure. I strongly urge the committee to reconsider this procedure as it has become a large part of my practice with more and more patients experiencing benefit and allowing me to offer patients a truly minimally invasive treatment for their painful condition.

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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. Patient selection is the most important factor in predicting this kind of success. Obviously every patient that has stenosis will not be a candidate for PILD. When I have selected out those patients that have stenosis STRICTLY from ligamentum flavum hypertrophy, and have true radicular pain, not simply axial back pain, the outcome has been life changing for the patient. I have a gentleman in his upper 70's that still acts, dances and sings on stage and screen and he has been able to continue doing this due the PILD procedure I performed for him 2 years ago. He has had no radicular pain since. I have about ten more patients just like him.

It is thus my belief that PILD is a medically necessary procedural option for patients with spinal stenosis. Outcome studies show that as does my anecdotal experience. Patients invariably prefer a percutaneous procedure to an open one for obvious reasons (less cost, less hospital time, less pain, less blood loss). They are invariably disappointed when I tell them that they are not a candidate for various reasons (previous surgery, preponderance of axial back pain, severe degenerative disc disease, preponderance of bony stenosis). But when done for the right patient for the right reasons the results are overwhelmingly positive.

I hope that the procedure will continue to be available to all patients including the Medicare population. Not all will be candidates and I will continue to be vigilant about screening patients appropriately. I hope the NCD can be reconsidered.

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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:

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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 secect group of patients. The long-term results patients have experienced have been durable.

There is clear diagnostic criteria for LSS and MILD candidates with 3mm of HLF and a positive response to epidural injections. MILD does not treat "back pain" but it treats symptoms of neurogenic claudication in patients that respond to epidural injections, so these patients are easily defined. The pain in this condition goes into the legs with ambulation and is very specific and also easy to define in spinal stenosis patients.

LSS with neurogenic claudication responds to decompression. Laminectomies and nonsurgical treatment options already exist to treat the condition, and MILD offers a minimally invasive technique to spare some patients the morbidity and mortality associated with more invasive procedures and associated adjacent segment disease and spinal instability that accompanies laminectomies. 80% of my patients that have had MILD have had relief of their neurogneic cluadication that has lasted more than 18 months. My complicaton rate is extremely low. The placebo effect is a significant risk,in all of medicine and is not specific for minimally invasive surgical procedures or interventional pain procedures.There are no blind, randomized, controlled studies of the alternatives to MILD including laminectomy, so to with hold treatment upon this basis is a disservice to the patients that Medicare insures.

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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 not felt to be surgical candidate based on medical comorbidities, age, patient preference and risk factors.

I would disagree with the comment that there is no clinical consensus on the diagnosis of spinal stenosis. LSS is what of the most frequently diagnosed conditions and spine centers and correlates well with outcomes from a variety of treatment including epidural injections and surgical decompression.I think to conclude otherwise should lead to a similar review of diagnostic criteria for any decompressive procedure of the spine. If the concern over specific diagnostic criteria is raised then it would be more appropriate to refine those criteria specifically based on canal measurement, ligament measurement and signs and symptoms of neurogenic claudication. Current treatments for LSS leave a significant gap in that many patients do not respond to conservative therapy such as exercise or epidurals and are not yet ready or able to undergo surgical treatment. This unmet need is often addressed using opioid medications, prolonged ineffective conservative management or lack of treatment.

Our experience to date is that the procedure has resulted in durable relief i.e. greater than one year, reduced opioid and adjunct of treatment such as epidural injections, improved functions such as walking and standing tolerance and significant patient satisfaction.

The placebo effect cannot be discounted and is likely similar to that of any surgical procedure including laminectomy and decompression. I would argue that the durability that the procedure has demonstrated so far would make a placebo response less likely.

With regard to the mechanism of action, the treatment effect is correlated to the improvement in epidural flow patterns after debulking of the enlarged ligaments. This mechanism is clearly visualized fluoroscopically and correlates with diminished intracanal pressure,improved epidural vascular flow and radically different pressure flow patterns above and below the stenotic level.

it is my opinion that to discount the mild procedure limits patients options traumatically to either conservative care or full surgical treatment.The future of spine care is minimally invasive, outpatient treatments such as mild.

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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 my practice who no longer have pain and have many others that I see less frequently than prior to the procedure because of reduced pain.

To date, after approximately 35 patients, there have been no adverse events related to the procedure.

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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, clinically and cost wise.

Using the cited the reasoning for not covering PILD, CMS should not cover any of the current the treatment optins for LSS.

I urge reconsideration of the decision.

Regards,

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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 avoid low back surgery which is usually a death sentence for an individual's quality of life.

Vertos Medical has done a good job of ensuring against the misuse of this procedure. Thus with limited number of physicians able to offer this treatment, the patient selection has also resulted in good outcomes. Perhaps the most important aspect of any procedure/ surgery is patient selection.

The incomprehensible aspect of this decision is that when compared to options currently offered for patients with LSS, this is the most effective and least invasive. The assumption for the previous statement is that we are limiting this procedure to mild- moderate LSS with claudication. Of the invasive options that are available, low back surgeries including laminectomy and fusion, mostly result in disability and the long term outcomes are unjustifiable when compared to conservative measures. The other minimally invasive procedure of X Stop has literature that is more inconclusive than that of the MILD.

Ultimately this is a disservice to the individuals that suffer from LSS and either they do not want open back surgery or may not be good candidates for general anesthesia. The other factor in all of this is that this decision is much to the delight of the spine surgery community. They will continue to perform invasive procedures resulting in disabiltiy and a complete devastation of the QOL for these patients. The unfortunate part is that patients will never know what they lost and the surgeons will continue to contribute to the disability epidemic in this country.

I urge you to reconsider your decision and perhaps allow more time to gather more data.

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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 if they had this affliction? There is substantial data showing benefits for patients, with a good safety record for this procedure. The denial of Medicare coverage would effectively block our seniors from getting this needed therapy, or would force them to consider much more costly and resource-consuming open procedures. I urge that this therapy be kept available for our seniors.

Sincerely,
Dr. William Baumgartl, MD

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