Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis

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

I strongly support the mild procedure as I have seen significant improvement in my patients following treatment using the mild procedure. I look forward to being able to provide the mild procedure again to my patients.

Thank you for your consideration.

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

The comments posted so far have focused on the significant body of evidence for the MILD procedure and so I won’t contribute more to that discussion. The data has repeatedly shown the procedure to be safe, efficacious, and low cost. These studies have been conducted across a wide range of settings and by a wide range of clinicians including some of the most prestigious medical institutions in the world. What is impressive is that all the studies show remarkable consistency in positive results. There are many therapies that are currently reimbursed that don’t have robust data demonstrating safety and efficacy but MILD is not one of them. Also, rather than deliver high priced care, this procedure has been designed specifically to provide significant efficacy and safety outcomes at a low cost and therefore to help the United States healthcare system save money. This is one of the key reasons we invested in the company.

You have received many comments from physicians and of course those are very important, but I think it is important for you to hear the investor’s perspective as well since your proposed decision has implications beyond MILD. The U.S. has long been a leader in medical innovation, which has led to better therapies for patients, highly skilled jobs, and American exports around the world. As someone who works in the medical innovation industry every day, I can tell you with certainty that the difficulty, unpredictability, time, and cost associated with gaining regulatory approvals and then reimbursement in the U.S. has had a dramatic negative impact on medical innovation in the U.S. A very large number of venture capital firms who fund medical device technologies have either gone out of business or re-focused on other industries over the last several years. Others have chosen to launch products outside the United States. This draft decision to continue CED after the original requirements of CED have been met significantly reinforces this problem.

Investors understand that investments are needed to fund clinical studies to demonstrate safety and efficacy. These investments carry substantial risks and require many years to complete, which we accept. There has to be a balance, though. In theory it would be nice to have an infinite amount of study data on all procedures and one can always come up with incrementally useful additional questions to pose about any therapy. The reality, though, is that emerging companies have to spend tens of millions of dollars and many years developing rigorous clinical development programs to prove safety and efficacy. This is certainly the case with Vertos who has spent millions of dollars before the CED and has spent 3 years and millions of dollars more to develop evidence in the MiDAS ENCORE CED study while foregoing tens of millions of dollars in revenue. There has to be a point when there is enough data collected to make a determination whether a therapy is reasonable and necessary, otherwise the company is not viable as an investment. With the significant number of clinical studies and tens of thousands of patients treated with consistent outcomes, MILD has reached that point. CMS asked for (and participated in the design of) an additional clinical study for MILD as part of the CED process. The data from the study is overwhelmingly positive and consistent with prior studies so it is reasonable to assume that the CED requirements have been met and MILD should be granted broad coverage.

I am passionate about investing in therapies that improve patients’ lives and reduce health care expenditures. It is, however, simply not a sound financial investment to fund companies that face high reimbursement risk associated with a CED process that requires an undefined amount of studies, takes many years to complete, and has no clear path to coverage. Without the support of investors to fund these types of studies, companies will be forced to forego the U.S. market, focus on non-Medicare patients, or not develop products for treating conditions suffered primarily by Medicare patients. I understand that CMS is trying to make the best decisions it can, but a CED process that does not result in coverage after successful completion of an agreed upon study severely undermines the credibility of the process. The introduced unpredictability of this draft decision provides a strong incentive for investors to not participate in future CED studies. I would ask you to reconsider your draft decision and grant broad access to the MILD therapy without the need for an additional CED study.

Thank you for your time and consideration.

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CMS stands to lose credibility.

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

Lumbar spinal stenosis is a condition that affects many patients in our clinic; a clinic that sees over of 12,000 patient-visits annually. The condition can place a very heavy burden on both the patient as well as supporting family members - as well as a financial burden on medicare. Before mild, treatment of patients with lumbar stenosis fell into two basic categories. Either they embarked on conservative management (epidural steroid injections, physical therapy, medications etc.) or chose invasive surgery. Mild fills an important step in the treatment continuum for LSS, particularly for patients that were either too frail or for those who had no desire to undergo major surgery.

CMS required level one evidence, and they got it.

The recent CED study, MiDAS ENCORE, produced level one data, supporting PILD as a therapeutic option.
For the organization to further lay another burden (in the form of requiring redundant, less valid research)on Vertos is simply inane. CMS further denying coverage of this procedure for patients in need is simply unethical. CMS should be ashamed.

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CMS needs to approve the Percutaneous Image-guided Lumbar Decompression procedure. The outcome study demonstrating safety and efficacy has been met via the Midas Encore study. There is no justification for further costly and unnecessary research to be performed prior to approving the procedure. I have already had to defer countless patients who would have benefitted from this procedure, and further delays will only deny access to many, many more patients who suffer from spinal stenosis and who are not good candidates for the more invasive, more dangerous and more costly laminectomy surgery.

Furthermore, adding more roadblocks to the process will only stifle further incentives to research and development of innovative medical technologies.

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

I am troubled to hear that once again my patients will not have access to this proven treatment as an additional cohort study is requested. An additional cohort study is contrary to CED requirements. It would provide lower quality evidence when CMS already has higher quality data in hand proving the therapy. When you request more data from a new therapy and then ignore the newer high quality data you tell all innovators that new advances will be stifled. This will surely limit further innovations if there. are no clear pathways to approval for proven new therapies. You have a proven, safe, and effective treatment for patients with symptomatic spinal stenosis. Please untie our healing hands and allow us to help our patients.

Sincerely,
Chad McNeil MD
Azalea Orthopedics
Tyler, Texas

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

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

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

There is no effective treatment short of decompressive laminectomy that often requires fusion. The Mild procedure can be offered to patients whose medical condition does not admit of open surgery or fusion.

At present, I have to inform patients that yes I could help, but CMS has ruled not to pay. CMS sponsored a study, and provided criteria for success.

CMS when presented with the data that fulfilled their requirements, created more requirements. Patients might think this is a system was set up to be fair, but then changed when they were close to receiving benefit.

In the future, the invitation from CMS to participate may appear to be a costly exercise in futility, a process that, like many treatments, lacks construct validity.

I urge CMS to adhere to it its own procedures and processes, just as CMS expects clinicians.

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October 8, 2016

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

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

Dear Ms. Syrek-Jensen:

The American Academy of Pain Medicine (AAPM) is the primary professional medical association for physicians practicing the specialty of Pain Medicine in the United States. On behalf of the Board of Directors of the American Academy of Pain Medicine (AAPM) and our nearly 2,400 physician members, we appreciate the opportunity to comment on the Proposed Decision Memorandum for Percutaneous Image-guided Lumbar Decompression (PILD) for the treatment of symptomatic lumbar spinal stenosis (LSS).

We are opposed to the proposed extension of Coverage with Evidence Development (CED) and the resulting restrictive requirements for the coverage of PILD. To date there have been at least 14 peer-reviewed studies published representing over 800 unique patients (ref. 1-14). The most recent study (13, 14) presented level-one evidence demonstrating clinical and statistical superiority over epidural steroid injections which are frequently utilized for pain relief for LSS. Furthermore, the safety profile far exceeded that of open surgical decompression. Accordingly, based upon the overwhelming body of evidence for effectiveness gathered over several years, we believe that additional studies for the purpose of determining coverage are not warranted and we respectfully support full coverage for PILD without the requirement for another study. Furthermore, the ‘Prospective Cohort Study’ proposed by CMS to gather additional data will only serve to severely restrict patient access to the therapy as most medical practices are not able to afford the staff, resources, and costs required to participate in the “Study” and many patients will not be able to participate due to follow up requirements and other administrative burdens.

Currently, patients with symptomatic lumbar stenosis who do not improve with conservative measures are faced with the choice of either major surgery or pain medications. There is an ongoing epidemic of pain medication overuse with devastating consequences in the United States. PILD represents a major advance and an important tool to help relieve pain in our elderly patients and provides our patients and their physicians with an effective alternative to the risks associated with traditional open surgery or chronic opioid therapy. It would be very difficult to justify denying the option of this less invasive therapy with lower complications and comparable efficacy for patients with symptomatic lumbar stenosis and relegating them to considering the options of open surgery vs pain medications. AAPM appreciates your thorough consideration of full coverage of the PILD procedure.

The American Academy of Pain Medicine

References:

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October 5, 2016

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

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

Dear Ms. Syrek Jensen:

The American Society of Regional Anesthesia and Pain Medicine (ASRA), on behalf of its 4500 members, appreciates the opportunity to comment on the Proposed Decision Memo captioned above.

Lumbar spinal stenosis (LSS) is a common cause of low back pain and/or leg pain. The prevalence is high and increases with age. As the elderly population continues to grow, the prevalence of LSS will also increase. The prevalence was reported to be as high as 47% in patients 60-69 years old. Unfortunately, the available therapy for this subset of patients is limited. Prescription opioids have proven ineffective and may cause unacceptable side effects in the elderly. Many elderly patients may not be good candidates for more invasive surgical options.

ASRA is supportive of a less invasive treatment option for patients with Lumbar Spinal Stenosis. The recently completed CMS-approved study (MiDAS ENCORE)¹ fulfilled the original requirements for CED as stated in the Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N). The study demonstrated statistically significant superiority of PILD versus the active control, at 1-year follow-up. Outcomes are assessed using the Oswestry Disability Index (001), Numeric Pain Rating Scale (NPRS) and Zurich Claudication Questionnaire (ZCQ).

Now that CMS has issued this new proposed decision memo, we are very concerned about the new requirements for coverage and the negative impact this will have on patient access and treatment.

CMS's decision memo states:

The decision memo goes on to state:

ASRA is concerned that these additional requirements will negatively impact patients suffering from LSS and impede patients' access to appropriate less invasive treatments. We are unaware of any other circumstance where CMS has required participation in a cohort study for coverage after completing a RCT trial.

The Agency of Health Care Research and Quality (AHRQ) classifies RCTs as level I, while prospective non-randomized trials as level II. Source: U.S. Department of Health and Human Services (http://www.ahrg.gov/).

The existing body of evidence, stemming from the CMS-approved study that fulfilled the original requirements for CED, clearly demonstrates the safety and efficacy of PILD.¹ Two published randomized controlled trials (RCTs), as well as systematic reviews provided evidence for efficacy using validated outcomes measures. The additional requirements for coverage that CMS is proposing here have no precedent and are inconsistent with coverage policies for other therapies.

ASRA appreciates this opportunity to weigh-in on this decision memo and urges CMS to reconsider these additional coverage requirements. Due to the complexity of chronic pain, clinical studies are difficult. Additionally, chronic pain and the current opioid epidemic crisis are major public health issues and are associated with significant financial and social costs. Therefore, it is essential to preserve all viable non-opioid treatment options for patients and ensure that they have access to such treatments. MILD is one such option that is less invasive and less costly than traditional surgical therapies, and society would benefit from CMS coverage.

Sincerely,

Oscar de Leon Casasola, MD
President, American Society of Regional Anesthesia and Pain Medicine

1 Benyamin RM, Staats, Mi DAS Encore I. MILD® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: Mi DAS ENCORE randomized controlled trial. Pain Physician 2016; 19:229-242.

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October 6, 2016

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

Dear Ms. Jensen,

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 recently released proposed national coverage determination (NCD) for percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis (LSS) patients experiencing neurogenic claudication. We share the agency’s dedication to patient safety, and as such, we provide the following comments.

PILD represents novel technology in the treatment of patients with lumbar stenosis who experience neurogenic claudication. As such, we agree on the need to evaluate this technology in a prospective randomized trial. The current literature on this procedure at this time appears discordant. Some industry-sponsored trials have demonstrated clinical efficacy while others have shown limited clinical efficacy requiring reoperation.^{1, 2} Mekhail and colleagues report a series of 58 patients who underwent the procedure demonstrating benefit at six weeks from the procedure. However, in another industrysponsored trial, Wilkinson and Fourney found limited efficacy at six months with 60 percent of the patients in their series of 24 requiring reoperation in that time frame. The authors hypothesize a placebo effect and increased narcotic use as a potential explanation for the short term benefit. A reoperation rate of 60 percent is concerning.

In an independent analysis of the procedure, Kreiner and colleagues surmised that the “current body of evidence addressing MILD (PILD) is of low quality. High-quality studies that are independent of industry funding and provide categorical data are needed to clarify the proportions of patients who benefit from MILD (PILD) and the degree to which these patients benefit.”³

In keeping with the need for high-quality studies, we are concerned with the current design of two prospective randomized controlled studies for which CMS is considering an NCD. One study has the investigative cohort being compared to patients undergoing a sham procedure; the second study is comparing the investigative arm patients to epidural injection therapy. The former study is designed to address the issue of a placebo effect; the latter study is to compare PILD to nonoperative measures, specifically epidural injection therapy. One of the criteria of the study design for approval established by CMS is the “study results are not anticipated to unjustifiably duplicate existing knowledge.” The study by Staats and colleagues appears to have already compared this procedure to epidural steroid therapy.⁴ The question that beckons to be answered is the efficacy of PILD compared with laminectomy. Such a study would be a meaningful contribution to the literature and further define the role of this technology.

Along with the alarming rate of reoperation with this procedure, we remain concerned with the safety profile. No device-associated complications have been reported in the industry sponsored trials. However, Tumialán and colleagues published their concern regarding the safety profile of this procedure reporting eight patients who needed additional surgery, two patients with a cerebrospinal fluid leak, one of whom had transected nerve roots from this procedure resulting in complete loss of bowel and bladder function.⁵

A thoughtful and independent analysis of data collected from a well-conceived randomized controlled trial will undoubtedly further define the role of this procedures. However, procedures that have demonstrated efficacy and a positive impact on patient care seldom await the result randomized control studies for a trend to surface showing a sustained utilization of a procedure. After all, surgeons and interventionalists migrate to procedures that achieve excellent and reliable clinical outcomes. Analysis of Medicare data for the tracking code (0275T) demonstrates that the PILD procedure peaked in 2013 with 2,623 procedures. In 2014, the procedure appeared to have been performed 187 times precipitously declining 22 procedures in 2015. It seems that as surgeons and interventionalists alike observed the efficacy of this technique over that period, enthusiasm for employing it waned. The current trend in utilization of the PILD procedure raises the question as to why CMS would want to extend coverage to this procedure when so few Medicare beneficiaries are having the procedure done in the setting of a disease state that is widely prevalent among Medicare beneficiaries — particularly if there are concerns regarding safety.

Thank you for considering our views. We appreciate the opportunity to comment on this coverage decision and look forward offering further guidance relating to the role of this technology in the treatment of lumbar stenosis with neurogenic claudication. If you have any questions or need additional information, please don’t hesitate to contact us.

Sincerely,

Frederick A. Boop, MD, President
American Association of Neurological Surgeons

Alan M. Scarrow, President
Congress of Neurological Surgeons

John J. Knightly, MD, Chairman
AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves

Footnotes

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October 8, 2016

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

Dear Ms. Syrek Jensen:

Thank you for the opportunity to comment on the Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression (PILD) (CAG-00433R). Vertos Medical writes to respectfully request that the Centers for Medicare and Medicaid Services (CMS) modify the draft decision to permit access to the well-established minimally invasive lumbar decompression (MILD) procedure for lumbar spinal stenosis (LSS) for appropriate patients under the agency's reasonable and necessary authority, while continuing Coverage with Evidence Development (CED) for distinct PILD procedures, as proposed, to allow for the completion of studies for these other PILD procedures.

Reasonable and necessary coverage is appropriate in light of the successful completion of the CMS CED-approved MiDAS ENCORE study and the full body of evidence for the MILD procedure, which includes more than 20 peer reviewed articles and 10 clinical studies in addition to MiDAS ENCORE. To date, more than 20,000 patients have been treated with MILD, in 48 states and by more than 800 physicians. Consistent with CMS's approval of the MiDAS ENCORE study's scope, size, design, and endpoints, as well as the overarching objectives of CED as articulated by CMS, the requirements for reasonable and necessary coverage have been met with respect to MILD. We urge CMS to recognize this success and to update the policy as suggested above. Consistent with this request, our comments include specific suggestions for patient selection, based on the existing body of evidence.

In addition to our scientific-oriented comments, we address larger, critically important concerns related to the disturbing policy implications of the draft decision. The Proposed Decision communicates to investigators, industry, patients, providers, and investors that the CED process and evidence analysis are unpredictable and that the commitments of time, effort, and funds to conduct and participate in these studies are not justifiable. We are deeply concerned that the draft decision, if not modified as we suggest, will undermine the integrity and viability of CED by discouraging stakeholders from conducting and participating in future CED studies. The draft decision also disincentivizes broader clinical research efforts and innovation. This set of concerns is particularly troubling because Vertos Medical cooperated with CMS in developing and conducting a randomized controlled clinical trial. Seeking to avoid these negative consequences, our comments suggest a pathway forward that both recognizes the fulfillment of the CED criteria with respect to MILD, while also continuing the CED for distinct PILD procedures.

1. The PILD For LSS CED Requirements Have Been Met With Respect To MILD.


1. CMS Established The CED Criteria And Approved MiDAS ENCORE Under Those Criteria.

The MILD procedure has been under CED for PILD since January 2014. At that time, CMS indicated that more data was needed to make a coverage decision and specified the nature of the additional study that was needed, in its view. Vertos Medical submitted a protocol in January of 2014 that met the CED requirements set out by CMS. Specifically, that protocol included:

• Prospective, randomized, controlled design using validated and reliable measurement instruments.
• Selection of a CMS-reimbursed therapy as a comparator (epidural steroid injections (ESI)), which meets the requirement of a 'clinically appropriate comparator treatment'.
• 1-Year endpoint, which meets the requirement of 'minimum length of patient follow up time'.
• A sample size and statistical plan designed to meet the threshold of 80% power in testing the primary superiority hypothesis.

The protocol also met the requirements of all three research questions identified by CMS. Specifically:

• Oswestry Disability Index (ODI) and ZCQ Function are validated measurement instruments designed to measure improvement in function. The success outcomes measure demonstrated statistical superiority to ESI, which fulfills the 'compared to other treatments' requirement.
• Numeric Pain Rating Scale (NPRS) and ZCQ Symptom are validated measurement instruments designed to measure improvement in pain. The success outcomes measure was demonstrated statistical superiority to ESI, which fulfills the 'compared to other treatments' requirement.
• The study selected a comparative clinical efficacy trial design with a CMS-reimbursed therapy as a comparator in order to provide relevant data affecting the clinical management of LSS.

CMS approved the protocol.including the sample size, duration, statistical plan, endpoints, and other trial design elements.on May 6, 2014. The approved protocol was designed with specific and significant input from CMS. Accordingly, the study design should have met the data requirements for a coverage decision; otherwise, the study serves no purpose and should not have been approved in the first instance. Financial commitments by the company and investors were made based on the understanding that CMS would approve coverage should the approved study be completed successfully.

The results of the CMS-approved CED study were published in a peer-reviewed publication in May 2016¹ and clearly demonstrate that all primary and secondary protocol endpoints had been achieved:

• Primary Endpoint: ODI Responder Rate at 1 Year (58.0% for MILD vs. 27.1 for ESI, p< 0.001).
• Secondary Endpoints:
  • NPRS Responder Rate at 1 Year (57.3% for MILD vs. 27.1% for ESI, p< 0.001).
  • ZCQ Symptom Severity Domain at 1 Year (51.7% for MILD vs. 31.8% for ESI, p=0.001).
  • ZCQ Physical Function Domain at 1 Year (44.1% for MILD vs. 17.8% for ESI, p< 0.001).
  • ZCQ Patient Satisfaction at 1 Year (61.5% for MILD vs. 33.3% for ESI, p< 0.001).

Extensive statistical sub-analyses and covariate analyses were presented to CMS on baseline factors, lumbar history, medication use, demographics, sites, and other issues identified by CMS as potential confounders in the agency's review of the protocol and approval of the trial design. All of this information conclusively demonstrated that there were no effects or confounders that could account for the significant statistical superiority demonstrated in this study. As such, using best clinical research practices, the only reasonable conclusion is that the treatment effect seen was statistically significant as a result of the difference in efficacy of the studied treatments.

2. The Proposed Decision Raises Issues Related To The Study Design That CMS Approved.

We are deeply disappointed that, notwithstanding our extensive communications and collaboration with CMS regarding the MiDAS ENCORE protocol, and the agency's approval of that protocol and involvement in its development, the Proposed Decision Memo raises several issues related to what CMS now refers to as the (approved) study's 'small sample size', 'short duration', 'high non-responder rate', waiting for 24-month data, and medication use. Sample size, duration, endpoints, responder definitions, medication use, and statistical plan were all topics addressed and worked through with CMS participation and approval during protocol development. Further, CMS did not raise these issues in its review of the six-month report from the MiDAS ENCORE data or in discussions and documented exchanges with Vertos regarding the CED reconsideration process and timeline.

Importantly, CMS provided extensive comments on the protocol prior to its approval, and discussions with CMS included specific discussions on topics now raised in the Proposed Decision Memo. For example, the timeline required to establish durability was directly discussed; 24 months was considered, but the time frame of 12 months was agreed to and expressly approved by CMS. To now require 24 months is to modify the criteria and expectations after approving the study under the previously communicated standards. Doing so redefines "adequate evidence" from a mutually agreed protocol design process, which included a priori objective outcomes measures, to a subjective standard that it seems will always impose new standards and demand more evidence after every completed study. This revising of standards renders the decision process opaque, unpredictable, capricious, and arbitrary.

As another example, the Proposed Decision Memo raises concerns around "missing post-operative data" - but it is unclear what this means. Protocol-defined data collection was accomplished for all but three out of the 274 treated patients. This is a very low dropout rate (1%). Accordingly, there should be very little missing data and impact on the overall assessment of efficacy.

Additionally, CMS expressed an interest in medication usage, but this was not defined as an endpoint or a focus of the study design. The intent of tracking medication, as discussed with CMS in the protocol approval process, was to assess whether it had a confounding effect on the observed endpoints. The study statistical analysis clearly demonstrated that medication use did not have a confounding effect and, thus, that the observed treatment effect was a result of the study treatments themselves. A narrow focus on medication usage also ignores the statistically superior outcomes achieved on primary and secondary validated outcomes measures, as well as other positive indicators such as differences in post-operative decompression procedures of 1.4% (2/143) for MILD patients compared to 13.7% (18/131) in the control arm.

Finally, the MiDAS ENCORE study was designed to be a comparative effectiveness study using a CMS approved therapy (ESI) as a comparator. The study clearly shows that MILD therapy was clinically and statistically superior to this CMS-approved therapy for the target population even once all possible confounders were analyzed. This study provides strong support for the conclusion that MILD is superior to a widely used treatment for this group of patients, and that such superiority is due to the MILD procedure itself. Therefore, the data clearly show that MILD is at least as reasonable and necessary as at least one CMS-approved active therapy comparator.²

Trials always involve trade-offs of rigor and feasibility, and every clinical trial ever completed might, in a perfect world, have had a larger sample size, longer duration, and so on. It is an inevitable reality of research that practical and statistical considerations are balanced in the protocol development process. But for CMS to point to illustrations of these realities now.retrospectively and after having explicitly approved the successfully completed protocol under the CED criteria.as part of a rationale to continue to limit coverage is unreasonable. We are gravely concerned about the transparency and validity of a CED process under which studies are approved but then later characterized as insufficient by CMS.

The Proposed Decision also mentions that CMS looks forward to seeing data from the Vertiflex trial, which focuses on a different PILD procedure, TotalisR. The Vertiflex data on Totalis should not have an impact on the coverage decision for MILD. First, as a factual matter, MILD and Totalis are distinct procedures that use different techniques and different tools, and that have vastly different bodies of evidence and rates of adoption. Significantly, and in stark contrast to MILD, there are currently no peer-reviewed publications on the Vertiflex Totalis technique, efficacy, or safety. As such, there is no scientific basis for comparing MILD and Totalis or grouping these two different procedures together in a single coverage decision. There is no accepted clinical framework that would allow one to make a conclusion on the efficacy of Totalis based on the MILD body of evidence, or vice versa.

Accordingly, MILD and Totalis should be evaluated separately, based on their respective bodies of evidence. MILD should be evaluated based on its established body of evidence, which includes more than 20 peer-reviewed publications and 11 clinical studies.including the CMS-approved, successfully completed, and published MiDAS ENCORE CED study. Totalis, on the other hand, lacks published data or peer-reviewed articles. To our knowledge, one active clinical study is underway but not yet completed.

A failure to distinguish these two different procedures for purposes of a coverage determination and evidentiary evaluation would be to penalize Vertos for having more data and more rapidly developing, completing, and publishing a CED-approved clinical trial. It would effectively make Vertos accountable for a competitor's performance in conducting a trial of the competitor's different product, and would make MILD dependent on the less well developed body of evidence and potential future results relating to a procedure that is, to date, unproven. To do so would be unfair, unscientific, and inappropriate.

Appropriate coverage criteria and appropriate limitations on coverage for MILD are available based on the criteria used in connection with the RCT successfully completed:

These criteria will limit the service to patients who are likely to benefit from the procedure.

AHRQ's CED guidance requires that the "research study is sponsored by an organization or individual capable of executing the proposed study successfully".³ The feasibility of further study is directly related to the sponsor's ability to fund it. The sponsor's access to capital for funding is greatly affected by all of the following, among other factors: the extent of access granted under the Decision; the total financial burden of the new study; and the exit timeline and clarity of the requirements for coverage on exit.

The recently completed MiDAS ENCORE study incurred more than $6 million in direct costs to design the study, obtain IRB approval, enroll and set up 26 sites, enroll 302 patients, collect baseline/6 month/1 year data, maintain and manage data, conduct independent monitoring, complete independent statistical analysis, engage in study investigator oversight, and other trial tasks. Revenue generated from sales to study patients (covered under the CMS facility fee) covered less than 5% of these direct costs, clearly demonstrating the heavy financial costs incurred by the sponsor for trials like these.

What is more problematic than the cost, though, is the extremely long period of time without reasonable coverage. The CED decision in January 2014-which was issued approximately 7 years after MILD first became available to patients-eliminated access to the procedure, cutting off availability of this treatment option for patients and leaving the company with virtually no revenue generated outside of the study for the last 3 years. The draft decision would continue to cut off access for patients and resources for Vertos to maintain this safe, effective, and proven treatment option.

As proposed, the new CED study contemplated by the draft decision would have very similar study administration and control requirements to the recently completed MiDAS ENCORE study, including IRB approval, patient consenting, study monitoring, patient data collection, data management, independent statistical analysis, study investigator oversight, and other elements undertaken with significant care, effort, and cost for MiDAS ENCORE. Based on our MiDAS ENCORE experience, it would take 4 1/2 years to design such a study, enroll 300 patients, collect data through 24 months, and publish results. It would likely take another 9 months for CMS to complete a Reconsideration. The result would be another 5 years of restricted access on top of 3 years already incurred for the original CED. MILD would be denied reasonable and necessary coverage for a total of 8 years, with corresponding burdens on patient access. There would also be an additional $5 million in direct costs to manage the study for 300 patients. Spending more than $11 million on studies with only very limited patient access for 8 years is untenable.

Even if this study were feasible, CMS may again, at the end of it, propose and potentially finalize a decision concluding that the previously established standards are no longer enough, and that yet another study would be needed. This is unreasonable as both a practical matter and a policy matter.

In addition, and equally importantly, we are concerned that core objectives identified by CMS in the proposed decision would not, in fact, be addressed by continuing CED for MILD. For example, CMS expressed a desire in the draft decision to offer broader coverage and to collect 'evidence in broader studies in less controlled settings that are more similar to real world practice.' The proposal to continue restrictive coverage for MILD under a new CMS-approved CED study would not meet this objective. The more appropriate course would be to articulate the circumstances under which MILD will be covered-consistent with the robust existing evidence-and continue evaluating the procedure as this broader coverage plays out and provides additional real-world evidence.⁴

Regarding the prospective cohort study specifically contemplated in the draft decision, this proposed study also would fail to meet CMS's stated objectives for CED, for the following reasons:

1. The proposed study would collect essentially the same data as was collected for MiDAS ENCORE, using an inferior study design. It would be duplicative of MiDAS ENCORE and the 7 completed prospective studies already conducted as part of the full body of evidence supporting MILD.⁵
2. A prospective cohort study would have significant study administrative requirements and controls that are similar to MiDAS ENCORE. To the extent CMS now has concerns that MiDAS ENCORE did not reflect or produce sufficiently "real world" outcomes, the cohort study, as described in the draft decision, also would not provide "real world" evidence. In our view, this concern is unfounded if it is asserted, given the significant body of evidence on MILD and its use.
3. The proposed prospective cohort study proposed is another controlled study that would require qualified staff and practices to administer. There are few interventional pain management practices that have the infrastructure to support controlled trials like CMS is proposing.
4. Obtaining follow-up data from practices and patients is difficult, particularly if pharmacy data is required. Collecting such data is especially challenging for LSS patients, as the current standard of care for the targeted patient population does not require long-term health data collection or follow-up visits, underscoring that the proposal does not reflect "real world practice".
5. A controlled prospective cohort study is, by definition, not conducive to enrolling more patients.

Lastly, the proposed cohort study does not provide clearly defined research objectives, objective success measures, study endpoints, or a number of other details. As such, there is no way to assess what benchmark needs to be achieved in order to establish coverage or a timeframe for exiting CED.

Continuing CED with respect to MILD is misaligned with the agency's own stated goals and policy. We are ready and eager to work with CMS on the establishment of appropriate, consensus-based criteria for coverage of MILD as reflected in our proposed coverage criteria.

As outlined in the sections that follow, the Proposed Decision improperly applies a new, heightened coverage standard to MILD that CMS has not applied to other LSS interventions, such as open surgery laminotomy and laminectomy, or to other minimally-invasive procedures or other treatments, such as ESI and neurostimulation, that have similar (or even lesser) levels of evidence. If CMS were to adopt the Proposed Decision, this would represent an arbitrary and capricious exercise of the agency's authority.

1. The Proposed Decision Unreasonably Imposes A Different Coverage Standard On MILD Than CMS Has Imposed On Other LSS Interventions Or On Other Minimally-Invasive Procedures.

MILD is a minimally-invasive laminotomy procedure that treats LSS. Laminotomy also can be performed as an open procedure; an open procedure is used, as well, to perform the more aggressive laminectomy surgery that also treats LSS.⁶ CMS consistently has provided coverage for this open surgical procedure (i.e., open surgery laminotomy), as well as coverage for open surgeries to conduct the more aggressive and invasive procedures of laminectomy and spinal fusions.⁷ Thus, MILD is a procedure that performs the same treatment as a more invasive (and already covered) reasonable and necessary service. Yet the Proposed Decision would continue to restrict coverage to MILD-a minimally-invasive approach to the same treatment (laminotomy) to achieve the same objective (spinal decompression)-absent evidence that MILD "improves health outcomes in Medicare beneficiaries with LSS," as demonstrated through a new RCT requirement, followed by a new prospective cohort study requirement with a minimum "24-month" endpoint.⁸ To do so would unreasonably impose a new, heightened standard on MILD that CMS has not imposed on other LSS interventions.

Further, CMS has not imposed these new conditions to coverage-(1) evidence of "improved health outcomes" or (2) demonstration of such evidence through an RCT and/or a prospective cohort study with a required 24-month endpoint-on other minimally-invasive procedures that, like MILD, offer a less invasive approach to an already-covered open surgical procedure that treats the same condition. In other cases of procedures that provide a minimally-invasive version of a treatment traditionally done as an open surgical procedure, CMS (having previously determined that the open surgical procedure was reasonable and necessary for treatment of the relevant disorder) did not demand evidence that the minimally-invasive method of providing essentially the same treatment as the (already-covered) open surgical procedure improved health outcomes. CMS likewise did not require completion of an RCT or prospective cohort study-let alone both-with a 24-month endpoint, nor did CMS require the attainment of any particular outcomes in such RCT and/or prospective cohort study as conditions to the coverage of other minimally-invasive methods of providing treatments already covered as reasonable and necessary when done through open surgery. Imposing these coverage requirements on MILD is fundamentally inconsistent with CMS's longstanding policy and practice, raising significant issues under the Administrative Procedure Act (APA).⁹

Moreover, imposing these new prerequisites to coverage on MILD is particularly unreasonable because each component of this proprietary procedure is well-established and previously has been covered. As noted in the draft decision, MILD requires the treating physician to make a small incision near the patient's spinal canal, through which proprietary tools are used to percutaneously remove a portion of the lamina and debulk the ligamentum flavum "under x-ray guidance (e.g. fluoroscopic, CT)."¹⁰ CMS consistently has covered other minimally-invasive procedures requiring a small incision,¹¹ and consistently has covered the use of fluoroscopy and CT in a variety of settings.¹² CMS identifies no component of the proprietary MILD procedure that requires further investigation in an RCT setting and a subsequent prospective cohort study.

2. The Proposed Decision Imposes A Different Coverage Standard On MILD Than CMS Has Imposed On Other Treatments For LSS Or Other Pain Conditions.

The coverage standard that the Proposed Decision imposes on MILD is also invalid for the independent reason that it is fundamentally inconsistent with the standard CMS has imposed on other treatments for LSS or other pain conditions. CMS routinely has covered other treatments for LSS without requiring proof of improved health outcomes or an RCT and/or additional prospective cohort study with a 24-month endpoint. For example, CMS routinely has covered treatments such as ESI and neurostimulation, among others, for patients suffering from LSS or other pain conditions without imposing these requirements.¹³ It is arbitrary and capricious, and a violation of the APA, for CMS to impose a different coverage standard on MILD than it imposes on these other treatments designed for what the agency regards as an overlapping patient population (such as in the case of ESI) or for similar patient populations experiencing pain conditions (such as in the case of neurostimulation).¹⁴

The draft decision, if finalized, would jeopardize continued patient access to MILD, a procedure that has been proven to be safe and effective, to produce positive outcomes for appropriate patients, and to be cost-effective. Moreover, and more broadly, the proposed continuation of CED for MILD even after successful and statistically significant satisfaction of all outcomes under the CMS-approved CED study sends a message to innovators and investigators that research expectations are not clear, and that studies conducted under CED will not necessarily be acceptable notwithstanding their approval by CMS. This draft decision, if finalized, would severely undermine the goals of CED, undercut parallel review programs, and fundamentally threaten future research.

We believe that we have fulfilled the CED requirements laid out in January 2014 through the successful completion of the CMS-approved MiDAS ENCORE CED study. As such, we request that CMS issue a final decision that permits coverage for MILD as reasonable and necessary for appropriate patients, without further CED study requirements, while continuing CED for distinct PILD procedures that have not yet completed a successful, CED-approved randomized clinical trial.

Thank you for your consideration.

Sincerely,

Eric Wichems
President & CEO
Vertos Medical, Inc.

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Mubin Syed, M.D.
Dayton Interventional Radiology

Dear CMS

Please consider reimbursement for the MILD procedure without the proposed prospective cohort study. I believe that the proposed prospective cohort study is not needed because there is already level one data through the recent CED study, the MiDAS encore study. Furthermore, there have been 20,000 patients that have been treated to date with over 12 studies that have been published to date. I believe that the encore study was definitive in support of the MILD procedure. There was coverage of the MILD procedure previously during 2014 wherein patients clearly benefited. I believe that my patient should deserve the Mild procedure as a treatment option. In my experience, I found that the treatment was very beneficial for patients at least 70-80% of the time. The MiDAS study gives a scientific level one data to support that this is the case. I believe that additional studies such as the proposed prospective cohort study would be expensive due to the need for extensive infrastructure in my practice. This would make performing the study cost prohibitive. Furthermore, many patients would not be willing to enroll because they would be given the false impression that the procedure is experimental. I believe that the MILD procedure is already a safe and effective interventional pain procedure. Covering the procedure only through yet another study, the prospective cohort study would be inappropriate and create a significant hardship on our practice to execute. I do not believe that an additional study should be required at all. In addition, I do not think that there is any conflict with surgeons because many of the patients that are qualified for MILD cannot tolerate surgery anyways or their symptoms are not so significant as to require surgical intervention.

Thank you for your consideration.

Sincerely,

Mubin Syed, M.D.

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

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

TPS is a stakeholder with our Texas local carrier, Novitas, we have members who serve as CAC representatives and are regularly involved with LCD reviews that pertain to the treatment of chronic pain. We have been appreciative of the transparency and processes laid out that Centers for Medicaid and Medicare (CMS) allow for organizations such as ours to be involved.

We feel that the process for determining the coverage determination for the mild procedure has not been transparent or fair. We feel that additional requirements are being asked that are not routinely asked of other procedures. TPS is disappointed by the disregard of process and objects to the additional requirements that are being asked to determine the coverage for this procedure.

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It is with great disappointment I read CMS negative decision with respect to percutaneous image-guided lumbar decompression (PILD) procedure coverage. CMS promised in its deliberations during the previous request for national coverage determination (NCD) that CMS itself would co-design a study and based on the results of that mutually agreed study, should it meet the endpoints, offer coverage of PILD to Medicare beneficiaries as an NCD. It is beyond the pale that despite meeting all endpoints regarding superiority of PILD for spinal stenosis over epidural steroid injection it is being subjected to still further requests for study. The peer reviewed literature is unequivocal in demonstrating safety, effectiveness, and cost savings of PILD over open laminectomy for treatment of spinal stenosis that is due primarily to ligamentum hypertrophy.

This negative decision will stifle any innovation within the medical device and technology sphere with regard to Medicare patients. This decision consigns millions of elderly Americans to ineffective open back surgery (see the SPORT study) or the use of deadly opiates . One can only conclude with cynicism that CMS wanted a result to demonstrate ineffectiveness of epidural steroid injections for ligamentum hypertrophy based spinal stenosis, and then purposely ignore the clear superiority and effectiveness of PILD for spinal stenosis, so that the open back surgery lobby within the AMA would be satisfied. This is a completely wrongheaded conclusion, and is an outrage.

In this day and age of evidence-based medicine, the literature to date including over 17 peer-reviewed studies including CMS's own internally designed level one evidence study that was paid for and executed, not by the taxpayer, but by VERTOS at CMS direction, all concluded that PILD is extremely effective and safe for the treatment of spinal stenosis. It appears, that the administration and CMS merely pay lip service to the concept of evidence-based medicine, and are really heading towards either a rationing-care model, or are beholden to special interests that advocate continued ineffective, unsafe, open back surgery, or use of deadly ineffective medications, on behalf of the pro-pharma lobby.

In the past 7 years, I have treated well over 450 patients with PILD, and more than 80% of my patients had greater than 70% relief of their neurogenic claudication symptoms. I have seen lives restored and diminished use of precious medical resources as a result. I only hope the combined outraged expressed here with hundreds of other responses will sway the decision makers. At the very least, I am proud to leave my dissenting voice open to public inspection.

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October 7, 2016

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

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

Dear Ms. Syrek Jensen:

The Advanced Medical Technology Association (AdvaMed) offers the following comments on the Centers for Medicare & Medicaid Services’ (CMS) Proposed Coverage Decision Memorandum for Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS). In the proposed decision memorandum, CMS proposes to continue Medicare coverage of PILD for LSS under Coverage with Evidence Development (CED).

AdvaMed’s member companies produce the life-saving and life-enhancing medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.

Our comments relate to the continuation of CED in the proposed coverage determination.

Use of CED in the Proposed Coverage Determination

AdvaMed has long supported the use of sound evidence to inform medical practice. As such, we generally believe CED can generate additional evidence in cases where the available evidence regarding a promising medical technology or procedure is not sufficient to support broad, national coverage. In appropriate circumstances, coverage contingent on the development of additional evidence can provide beneficiaries with access to innovative medical treatments when the alternative is non-coverage.

CED allows CMS to provide coverage within the context of studies that conform to standards detailed in Medicare’s Clinical Trial Policy. The research meeting these standards can include a range of research approaches.

AdvaMed has submitted comments to CMS regarding its CED guidance generally, and many of the concerns we have raised in that context are relevant with respect to this proposal with respect to the requirement for continued CED. AdvaMed strongly believes that Medicare’s coverage policies should encourage innovation, and that CED should expand, not restrict, patient access to new technologies and treatments. We also urge CMS to continue to find avenues in NCDs whereby the Agency may impose certain conditions for coverage (for example, specific provider or institutional requirements) without finding that the evidence is insufficient under §1862(a)(1)(A) of the Act and therefore placing the NCD under §1862(a)(1)(E).

CMS states in its proposed coverage determination that it proposed to continue coverage of PILD for LSS in a prospective cohort study meeting certain characteristics, because the agency was encouraged by early findings of improved function, reduction in pain and improved quality of life. When positive results are achieved, we would hope that such findings would result in broader coverage without continued CED.

When Medicare coverage is contingent on the collection of additional clinical or scientific evidence (beyond FDA requirements for safety and efficacy), we believe CMS should:

1. collaborate with stakeholders to clearly identify the data collection objectives,
2. consider the minimum data necessary to achieve those objectives, and
3. clearly identify, with input from interested stakeholders, scientifically supported study endpoints and the duration of data collection in advance.

In considering the minimum data necessary, CMS should also consider whether additional data being developed through FDA-mandated post-market studies satisfies CMS’ evidentiary needs for coverage. In addition, coverage policies should be sensitive to the practical challenges associated with generating evidence, and should support patient participation in clinical trials. Ultimately, as CED generates evidence supporting the use of a new innovation or services, Medicare’s coverage policies should reflect these outcomes and minimize additional requirements.

If you have questions regarding these comments or if you require additional information, please contact me or Chandra Branham, JD, Vice President, Payment and Health Care Delivery Policy, at (202) 434-7219 or cbranham@AdvaMed.org.

Sincerely,

/s/
Donald May
Executive Vice President
Payment and Health Care Delivery Policy

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October 7, 2016

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

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

Dear Ms. Syrek Jensen:

The American Society of Anesthesiologists (ASA), on behalf of its 52,000 members, appreciates the opportunity to comment on the Proposed Decision Memo captioned above. As many physician anesthesiologists specialize in pain medicine and treat patients suffering from chronic pain, ASA is supportive of a less invasive treatment option for patients with Lumbar Spinal Stenosis (LSS). When the Centers for Medicare and Medicaid Services (CMS) issued its initial public comment period for PILD (4/13/2016- 5/13/2016), ASA wrote in support of CMS’s decision to reevaluate its coverage determination for PILD once reliable published data was available. Now that CMS has issued this proposed decision memo, we are very concerned about the new requirements for coverage and the negative impact this will have on patient access and treatment.

CMS’s decision memo states:

The decision memo goes on to state:

ASA is concerned that these additional requirements will negatively impact patients suffering from LSS and impede patients’ access to appropriate treatments. We are unaware of any other circumstance where CMS has required participation in a cohort study for coverage after completing a randomized controlled trial (RCT). The existing body of evidence, stemming from the CMS-approved study that fulfilled the original requirements for CED, clearly demonstrates the safety and efficacy of PILD.¹ Two published RCTs, as well as systematic reviews and retrospective published studies all show statistically significant efficacy using validated outcomes measures. The additional requirements for coverage that CMS is proposing here have no precedent and are inconsistent with coverage policies for other therapies. ASA urges you to reconsider this proposal.

LSS is a degenerative condition that many patients face as they age, often resulting in back and leg pain. As the aging population continues to grow, along with the number of beneficiaries receiving Medicare, the incidence of LSS will increase. Unfortunately, the availability of treatments for this subset of patients is limited. Prescription opioids have proven ineffective and cause unacceptable side effects in the elderly, while physical therapy has helped only a small number of patients. In addition, chronic opioids for patients with LSS in the elderly have not been shown to be effective in long-term studies. Also, with the current opioid epidemic crisis, recommendation of opioids for LSS would only enhance this problem. Furthermore, surgery is not always an option for these patients either, as the risks often outweigh the benefits in elderly patients. Moreover, surgery is quite invasive, costly and studies show it has a limited lifespan.

PILD is a viable and less invasive treatment for patients with LSS. PILD can provide pain relief or reduction in pain, as well as improving patients’ function and mobility. There is minimal risk and sustained benefit for pain and function, but still may not prevent the need for subsequent surgical intervention in some patients.

ASA appreciates this opportunity to weigh-in on this decision memo and urges CMS to reconsider these additional coverage requirements. While chronic pain is being more widely recognized as a public health issue, health care is also becoming increasingly more expensive. Therefore, it is essential to preserve all viable treatment options for patients and ensure that they have access to such treatments. Thank you for your time and consideration. Please do not hesitate to contact ASA staff with any questions.

Sincerely,

Daniel Cole, M.D.
President
American Society of Anesthesiologists

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October 7, 2016

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

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

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

Dear Ms. Syrek-Jensen and Ms. Gilbreath:

On behalf of the Board of Directors of the American Society of Interventional Pain Physicians (ASIPP) and 51 state societies including Puerto Rico, and the membership of all these societies, we appreciate the opportunity to comment on the Proposed Decision Memorandum for Percutaneous Image-guided Lumbar Decompression (PILD).

We are disappointed and oppose the proposed extension of Coverage with Evidence Development (CED) and the introduction of new requirements for coverage. The recently completed CMSapproved study (MiDAS ENCORE¹) fulfilled the original requirements for CED as stated in the Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N). The results of this study and the existing body of literature clearly establish mild® as reasonable and medically necessary. Efficacy and safety are comparable or exceed currently covered surgical, interventional, and conservative therapies. As such, unrestricted coverage without the need for additional studies under CED should be granted. We therefore respectfully request that you change your draft coverage policy on PILD to a final coverage policy that grants full coverage for the mild® procedure without the requirement of doing another study. Not reversing this illogical and inappropriate decision is deleterious to patient access and investment in innovations.

Interventional pain management is defined as the discipline of medicine devoted to the diagnosis and treatment of pain-related disorders principally with the application of interventional techniques in managing subacute, chronic, persistent, and intractable pain, independently or in conjunction with other modalities of treatment.²

Interventional pain management techniques are minimally invasive procedures including percutaneous precision needle placement, with placement of drugs in targeted areas or ablation of targeted nerves; and some surgical techniques such as laser or endoscopic diskectomy, intrathecal infusion pumps and spinal cord stimulators, for the diagnosis and management of chronic, persistent, or intractable pain.³

ASIPP is a not-for-profit professional organization founded in 1998 now comprising over 4,500 interventional pain physicians and other practitioners who are dedicated to ensuring safe, appropriate, and equal access to essential pain management services for patients across the country suffering with chronic and acute pain. There are approximately 8,500 appropriately trained and qualified physicians practicing interventional pain management in the United States.

We are commenting on all relevant issues as follows:

• The mild® Procedure has Fulfilled the Original CED Requirements
  The Medicare National Coverage Determinations Manual Chapter 1, Part 2 Section 150.13 – Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) states the requirements for an approvable study under the Coverage with Evidence Policy. Specifically:
1. A clinical study must address one or more aspects in a prospective, randomized, controlled design using current validated and reliable measurement instruments and clinically appropriate comparator treatments.
2. The study protocol must specify a statistical analysis and a minimum length of patient follow-up time that evaluates the effect of beneficiary characteristics on patient health outcomes as well as the duration of benefit.
3. The study protocol must produce data that demonstrate whether PILD provides clinically meaningful improvement in function and reduction in pain as well as whether PILD affects management of LSS compared to other treatments.

The MiDAS ENCORE Study met all three requirements. Specifically:

1. The design of the study was prospective, randomized, and controlled. It used validated and reliable measurement instruments such as the Oswestry Disability Index (ODI), Numeric Pain Rating Scale (NPRS), and Zurich Claudication Questionnaire (ZCQ). These are all clinically accepted outcome measures. Epidural steroid injections (ESIs) are a widely accepted treatment for these patients and meet the definition of a clinically appropriate comparator.^4,5 The Centers for Medicare and Medicaid Services (CMS) approved the outcomes measures and comparator treatment.
2. The statistical plan and sample size were designed to power the study and were deemed to be more than adequate for the protocol-defined endpoint analysis. The statistical plan and sample size were approved by CMS. The one-year endpoint is appropriate for an interventional pain management treatment comparative efficacy study and was approved by CMS, however, follow-up continues beyond one year.
3. The study’s outcome measures address the need to collect validated outcomes in function (ODI and ZCQ Physical Function) and pain (NPRS and ZCQ Symptom Severity). The selection of an active control (ESI) and requirement to demonstrate statistical superiority on endpoints provides the necessary information to assess the effect of mild® on clinical management of LSS compared to other treatments.

The MiDAS ENCORE study clearly met the CED requirements and the CMS approval of the study protocol validates this position. The clinical results on endpoints demonstrated statistical superiority at one year for ODI responder rates (58.0% for mild® vs. 27.1% for the control, P < 0.001), NPRS responder rates (57.3% for mild® vs. 27.1% for the control, P < 0.001), ZCQ Symptom Severity (51.7% for mild® vs. 31.8% for the control, P = 0.001), ZCQ Physical Function (44.1% for mild® vs. 17.8% for the control, P < 0.001), and Patient Satisfaction (61.5% for mild® and 33.3% for the control, P < 0.001). Endpoints of a CED-approved study were successfully achieved, so it is logical to conclude that the CED data requirements are met and CED should end. If a study was not intended to provide the necessary data to make an affirmative coverage decision, then the protocol should not have been approved.

The “Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development” issued by your department provides additional support for why mild® should exit CED now that the study has been successfully completed.

• Section IV. Principles governing the application of CED stipulates three areas that are relevant to this Draft Policy:
  1. CED will not be used when less restricted coverage is justified by the available evidence.
  2. CED will generally expand access to medical technologies for beneficiaries.
  3. CED will lead to the production of evidence complementary to existing medical evidence.

Continuing CED by adding a new requirement for a prospective cohort study contradicts these principles.

1. A requirement for a new study violates the precept that CED will not be used when less restricted coverage is justified by the available evidence. The MiDAS ENCORE study was approved by CMS and statistical superiority was established on all endpoints, so less restricted coverage is
2. A requirement for a new study limits patient access since only investigators from the MiDAS ENCORE study and can enroll patients in the new study, which violates the intent of expanding access to medical technologies for beneficiaries.
3. The new study will not produce evidence complementary to the existing medical evidence since the data required will be duplicative of data already collected in the MiDAS ENCORE study and the published cohort studies conducted to date. The fact that the requested data is duplicative also goes against the NCD, which states that “The research study does not unjustifiably duplicate existing studies.”

• Section VIII. Ending CED, states “We expect that the studies conducted under a CED NCD will produce evidence that will lead to revisions to Medicare coverage policies, such as to the NCD that included CED as a component of the decision.” CMS approved the MiDAS ENCORE protocol and the study demonstrated clinically significant and statistically superior outcomes so a meaningful revision to the policy should result. The proposal to do another study does not constitute a meaningful revision.

In summary, the mild® procedure has clearly met the requirements set by CED. The study protocol was approved by CMS and the study successfully demonstrated significant statistical superiority on protocol-defined endpoints, so the therapy should be covered without needing to do another study under CED.

• The mild® Procedure Body of Evidence is Comparable to Current Medicare Covered Procedures

  The Draft Policy issued by CMS requires a level of evidence to which no other therapy in the category has ever been subjected.

  The mild® procedure now has:

  • Two published randomized controlled trials (RCTs),^1,6 with one high quality trial as designed by CMS for coverage development, providing Level I evidence (340 total patients / 164 mild® patients)
  • As shown in systematic reviews,⁷ an additional 7 prospective single-arm and 2 retrospective published studies (382 mild® patients)
  • 668 mild® patients have been studied in all mild® clinical trials
  • Five studies report 1Y follow-up of patients treated with mild® (326 patients)
  • One study reports 2Y follow-up of patients treated with mild® (45 patients)
  • All studies show statistically significant efficacy using validated outcomes measures.

  All eleven of these published studies,⁷ including two RCTs,^1,6 with one high quality trial as designed by CMS for coverage development, report that mild® provided statistically significant improvement in functional mobility and reduced pain compared to baseline. In addition, two RCTs demonstrated superiority of mild® versus the active control for all primary and secondary outcome measures. There were no reports of device-related adverse events in any of these studies.

  These reports are consistent regarding significant improvement in patient outcomes generated through high quality studies, including one high quality RCT providing Level I evidence of the effectiveness and safety of mild®. The strength of this evidence, which combines high quality study designs with significantly improved outcomes in all studies, surpasses that available for many common back treatments currently covered by CMS.

• Multiple covered therapies have similar or weaker evidence:

• A 2016 Cochrane Review by Zaina et al⁸ reviewed the evidence that compares surgery versus non-surgical treatment for lumbar spinal stenosis (LSS). After reviewing almost 13,000 citations, only three high-quality RCTs related to open surgery were identified (Amundsen 2000, Malmivaara 2007, Weinstein 2008). This review reports that there is low quality evidence from the meta-analysis performed on two trials that used ODI to compare direct decompression with or without fusion versus multi-modal non-operative care. The evidence showed no significant differences at 6 months and 1 year. At 2 years, significant differences favored decompression. Low-quality evidence from one small study revealed no difference in pain outcomes between decompression and usual conservative care at 3 months, four years and 10 years. Further, the rate of side effects ranged from 10% to 24% in surgical cases, and no side effects were reported for any conservative treatment. This Cochrane Review concluded that no clear benefits were observed with surgery versus non-surgical treatment, and that current evidence comparing surgical versus non-surgical care for LSS is of low quality.

• Phillips et al⁹ concluded that the body of literature supports fusion surgery as a viable treatment option for reducing pain and improving function in patients with chronic low back pain refractory to nonsurgical care when a diagnosis of disc degeneration can be made. Bydon et al¹⁰ concluded that despite the significant improvement in Oswestry Disability Index (ODI) scores in the lumbar fusion groups in 3 studies, pooled data revealed no significant difference when compared to the nonoperative groups. Saltychev et al¹¹ also reached similar conclusions regarding the lack of strong evidence for lumbar fusion compared to conservative treatment.

  Manchikanti et al¹² suggested fluoroscopically directed epidural injections provide longterm improvement in back and lower extremity pain for patients with lumbar discogenic pain. They showed only limited evidence for the potential effectiveness of surgical interventions compared to nonsurgical treatments.

• National coverage for spinal cord stimulation (SCS) was established in 1995. However, the first RCT was not published until 2005, with a second trial in 2006, and a third trial in 2015.¹³
• In 2016 Grider et al¹³ conducted a systematic review of RCTs of spinal cord stimulation (SCS) in chronic spinal pain. The authors identified 6 RCTs, however only 3 of those studies assessed efficacy. Of the three randomized trials evaluating SCS, all reported effectiveness for short- and long-term relief. The authors concluded that the indicated level of evidence for SCS is Level I to II based on 2 high-quality RCTs and one moderate-quality RCT.


• Additional study requirement is unjust
  Additional requirements for coverage are unprecedented and inconsistent with coverage policies for other therapies. Additionally, a prospective cohort study with an inferior design will provide weaker quality data than the MiDAS ENCORE study and won’t achieve the stated goal of collecting “real world” information since the data will be collected in a controlled study format (similar to the MiDAS ENCORE study). In fact, the MiDAS ENCORE study from multiple academic and real-world practice settings with an active-control design has provided the best possible “real world data.” In addition, the additional study requirement puts an unreasonable demand on the interventional pain management specialty to continue to produce evidence when the current evidence already is sufficient. We understand that there will always be an interest in gathering more data on a therapy, but it cannot come at the cost of eliminating broad patient access to therapies that have already demonstrated therapeutic efficacy and safety.

In summary, at a time when pain management has become a significant public health issue and strong pressures to reduce health care costs exist, it is essential to preserve options like mild® that are inexpensive and have demonstrated efficacy and safety. This is a very important interventional pain treatment that can benefit thousands of patients that currently don’t have multiple options. Establishing a policy that requires a promising therapy like this to do more studies after successful completion of a CED study is counterintuitive to innovation and patient access. Support for access to promising technologies is not enabled by this policy. It not only defies logic, but also violates ethical principles. Further, such an attitude discourages investment in innovative technologies, apart from the grave injustice done to needy patients, sending them to ineffective and expensive treatments. Further, this also creates a significant credibility issue for the CED program. We respectfully ask you to issue a final policy granting coverage for this therapy without the requirement of doing another study.

Thank you and if you have any questions, please feel free to contact us.

Sincerely,

Signers

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October 7, 2016

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

BY ELECTRONIC DELIVERY

Dear Director Syrek Jensen:

The Biotechnology Innovation Organization (BIO) appreciates this opportunity to comment on the Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R).¹ As discussed below, we have serious concerns about this draft decision's implications with respect to the use of Coverage with Evidence Development (CED) and the resulting impact on Medicare beneficiaries as well as healthcare providers, researchers, and innovators.

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO's members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members' novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

As the representative of an industry that is devoted to improving healthcare through the discovery of new therapies, BIO is committed to evidence-based medicine and the policies that promote and facilitate it. We are deeply concerned, however, that, as proposed, the Centers for Medicare and Medicaid Services (CMS) draft decision would have the opposite effect, delaying or effectively denying patient access to appropriate medicines in the short-term and injecting regulatory uncertainty into the Medicare coverage system that can have upstream, long-term effects on the innovation ecosystem. Specifically, the decision here raises significant issues with respect to how CMS appears to be carrying out its CED policy. As we have commented on a number of prior occasions,² it is important that CED have a definitive resolution in order to avoid unnecessary burdens on beneficiaries, healthcare providers, and manufacturers. Further, the research questions and criteria to achieve this definitive resolution must be transparent, well-defined, and achievable. The current draft decision does not meet these minimum criteria, as CMS proposes to impose continued CED restrictions and study requirements despite the apparent completion of the originally agreed-on CED criteria.

Just as CMS recognized when it first developed principles for applying CED, the need to provide for a predictable coverage and reimbursement environment is still critical today. We have previously cautioned that the additional costs incurred as a result of a poorly designed and vague CED policy or inappropriate application of CED may negatively impact patient access to needed medicines in the short-term. This, in turn, can led to increased short-term healthcare expenditures (e.g., additional hospitalizations, physician office visits) and negatively impact patient health outcomes over the longer term (e.g., by allowing a disease or condition to continue to progress). Further, if manufacturers are unclear about the rationale for CMS's application of CED, investment in new or improved medical technologies may be deterred or delayed in reaching the marketplace. We write regarding this draft decision because it demonstrates that these concerns, which we have previously articulated to CMS, remain relevant. We encourage CMS to address these issues and ensure that the Agency's use of CED advances evidence-based medicine without creating unpredictability, delaying or effectively denying patient access to appropriate care, or hampering future medical innovation.

We note, as well, that while beneficiaries should be encouraged to participate in clinical research, they should not be forced to participate in research under CED in order to receive care that Medicare should cover based on the available evidence. Moreover, if the study criteria under a CED policy are defined too narrowly, they risk denying access to care for many beneficiaries who have comorbidities or are otherwise unable to participate in trials due to distance from a provider who is participating in the study or their unwillingness to change providers.

In addition to presenting obstacles to care for beneficiaries, CED can impose substantial costs on providers and manufacturers. To date, the costs of performing studies required by CED policies, including maintenance of registries and collection of data, have fallen on providers and manufacturers. As we have previously suggested, if CMS continues to use CED, we urge the agency to exercise caution and work with stakeholders to ensure that any application of CED is: based on robust medical and clinical evidence; explained and justified by specific and concrete research questions; and implemented in the most economical manner possible. The current draft decision does not meet these standards.

Finally, if CMS continues to utilize CED, we believe that the benefit of CED to Medicare beneficiaries would be maximized by continuing to apply the principles established in the 2006 guidance document. In particular:

• CED should not be used when other forms of coverage are justified by the available evidence.
• CED should, in general, expand access to technologies and treatments for Medicare beneficiaries.
• CMS should use CED infrequently.
• CED should lead to the production of evidence complementary to existing medical evidence, and should not duplicate existing studies.
• CED should not duplicate or replace the Food and Drug Administration's (FDA's) authority in assuring the safety, efficacy, and security of drugs, biological products, and devices.

We continue to believe that CMS should endeavor to develop coverage policies that are flexible and that allow for innovative diagnostics and therapies to get to the right patients, at the right time. It is critical that the appropriate Medicare beneficiaries gain access to innovative technologies that have been demonstrated to improve health outcomes-particularly in cases where there has been successful completion and peer-reviewed publication of randomized controlled clinical trial data obtained through a rigorous, high-quality study conducted with CMS input and approval under a CED decision. The CED process must be transparent and well-defined, and must provide predictability for participants in order to achieve CMS's stated objectives for this policy.

Please contact me if you have any questions about these comments. Thank you for your attention to this very important matter.

Sincerely,

/s/
Laurel L. Todd
Vice President
Healthcare Policy & Research

1 Centers for Medicare and Medicaid Services, Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-0433R) (Sept. 8, 2016), available at https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=284 (last accessed October 4, 2016).
2 For example, see BIO, Comments in Response to CED Public Solicitation (January 20, 2011), available at: https://www.bio.org/sites/default/files/files/2012_01_20_BIO_CED_Comments.pdf (last accessed October 7, 2016); BIO, Request for Comments Regarding Evidentiary Characteristics of Coverage with Evidence Development (April 16, 2012), available at: https://www.bio.org/sites/default/files/files/BIO%20MEDCAC%20CED%20Comments_April%2016%20%202012.pdf (last accessed October 7, 2016); BIO, Public Statement: Medicare Evidence Development & Coverage Advisory Committee Meeting Evidentiary Characteristics for Coverage with Evidence Development (CED) (May 16, 2012), available at: https://www.bio.org/sites/default/files/files/BIO%20MEDCAC%20Statement%20May%2016%2C%202012.pdf (last accessed October 7, 2016).

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Once again, on behalf of all the active members of the Florida Society of Interventional Pain Physicians (FSIPP), I would like to thank you for the opportunity to provide feedback on your recent “Proposed Decision Memo for PILD for LSS (CAG-00433R)”. As FSIPP has publically stated in previous open comment periods (05/04/2013 and 05/12/2016) we strongly support full, unrestricted access to the MILD procedure. Based on the extensive published outcome data available for MILD, and successful completion of the recent CED study (MiDAS ENCORE) we hold fast to this opinion, and thus, disagree with your current proposal that would continue to limit this proven therapy to a very small number of Medicare beneficiaries.

The first reason we disagree with your current proposal is due to the fact that the original CED requirements have been met. The CED Study, MiDAS ENCORE, was completed and all primary and secondary outcome measures were met. This data, coupled with the existing published, peer-reviewed outcomes data provides sufficient evidence for coverage. As stated in our comment posted on 4/21/2016 (see below), the 6-month outcome data for the CMS approved, level 1 MiDAS ENCORE CED study was consistent with all previous available study data on PILD (17). Since that comment was posted, the MiDAS ENCORE CED Study was completed and the 12-month outcome was published and reviewed by CMS. The results of this study show that at 1-year follow-up, ODI, NPRS, and all 3 ZCQ domains (Symptom Severity, Physical Function and Patient Satisfaction) demonstrated statistically significant superiority of MILD versus the active control. For primary efficacy, the 58.0% ODI responder rate in the MILD group was higher than the 27.1% responder rate in the epidural steroid group (P < 0.001). The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). These 1-year results of this randomized controlled trial demonstrate MILD as statistically superior to ESIs in the treatment of LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. Primary and secondary efficacy outcome measures achieved statistical superiority in the MILD group compared to the control group. With 95% of patients in this study presenting with 5 or more LSS co-factors, it is important to note that patients with spinal co-morbidities also experienced statistically significant improved function that was durable through 1 year (18). These results show that all clearly defined, CMS approved, endpoints were met and that PILD continues to demonstrate to be a safe and effective treatment for qualified patients. This treatment option has been extensively studied and consistent, positive, long term results have been achieved in every instance. This quality data allows us to confidently state that no further investigation is needed to determine coverage for this procedure and we encourage CMS join us in this conclusion.

The second reason we disagree with your draft decision is your current proposal adds new unnecessary requirements which will continue to limit this therapy to a select number of Medicare Beneficiaries. In the CMS approved study design of the MiDAS ENCORE CED study, patient selection criteria are clearly defined (18). There is an extensive Medicare population that fit these criteria and are currently limited in their treatment options. By only allowing treatment through a , unnecessary and limited prospective cohort study, you are denying access to the majority of patients currently suffering from neurogenic claudication symptoms caused by LSS due to hypertrophic ligamentum flavum. By limiting participation to a select number of study sites also creates the possibility of discriminating patients based on geographical and economic factors. This therapy has been proven to be a superior treatment option and should not be limited to a select group of predetermined patients.

In conclusion, PILD (specifically the MILD procedure developed by Vertos Medical, Inc.) has been extensively studied and has produced consistent, safe and effective results. The MiDAS ENCORE CED study, which was approved by CMS to help formulate a coverage decision, further confirms these results. FSIPP believes that there is more than enough evidence available to make a positive decision on coverage for this proven therapy and the CED process should be exited. By not developing a full coverage policy, a large number of your beneficiaries will continue to suffer needlessly. Thank you once again for your consideration.

FSIPP Reconsideration Comment – 05/12/2016
The mission of Florida Society of Interventional Pain Physicians (FSIPP) is to promote and ensure patient access to interventional pain management therapies in our state that are proven to be safe, high quality and cost-effective for the treatment of pain disorders. With that in mind, FSIPP would like to take this opportunity to provide our comments and support on the National Coverage Analysis (NCA) for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (PILD).

FSIPP has supported a favorable Medicare coverage decision for PILD/mild® since June, 2011, when we formally submitted a request for coverage to the Medicare Administrative Contractor (MAC) for our state, First Coast Service Options. Since that time, we have continued to support favorable Medicare coverage for PILD/mild® as a reasonable and necessary procedure for patients with mild-to-moderate lumbar spinal stenosis with neurogenic claudication where hypertrophic ligamentum flavum is a contributing factor. FSIPP supports mild via continued education at local/national meetings; additionally, our members have served as investigators in the CED Study - MiDAS ENCORE.

As mentioned in our previous comment posted in the in October 2013 NCD, the body of evidence available for PILD/mild® combined with our members’ clinical experience confirms that PILD/mild® is safe and exceedingly effective for patients suffering with lumbar spinal stenosis with neurogenic claudication. PILD/mild® provides a long term solution by addressing an underlying cause of neurogenic claudication. Patients experience a significant improvement in mobility and a reduction in pain, allowing them to better perform activities of daily living (e.g. walking, standing, self-care, social engagement). The recently published data from the MiDAS ENCORE study provides further evidence of these improvements in addition to superiority to ESIs, the current standard of care for LSS with neurogenic claudication. (17)

At 6 months (17):

• The proportion of ODI responders in the PILD/mild® group was statistically significantly higher than for the ESI group (this was the primary endpoint).
• Secondary endpoints (NPRS and ZCQ) also showed statistical superiority in responder rates for PILD/mild® compared to ESI.
• There was no statistical difference in safety endpoints between PILD/mild® and ESIs.

PILD/mild® fills an important treatment gap for patients with lumbar spinal stenosis with neurogenic claudication by providing a safe, simple and effective solution to their reduced mobility and discomfort. Our patients are actively seeking treatment solutions like PILD/mild® that will allow them to improve their function and participate in life. A positive National Coverage Decision (NCD) for PILD/mild® will ensure that all appropriately selected Medicare patients will have access to a treatment that is proven to be safe and effective as well as medically necessary and reasonable. FSIPP appreciates your thoughtful consideration of our comments and our strong support for a favorable NCD.

Sincerely,

Harold L. Dalton, DO
FSIPP, President

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

These patients normally don't respond to epidural steroid injection or any other conservative treatment. Ongoing conservative treatment and intermittent other interventional treatment makes overall patient care very expensive. Properly selected patients typically does extremely well with this procedure.

This procedure is not to replace major lumbar laminectomy decompression procedure. This is for those patients who are symptomatic, needing interventional treatment, pain medication but are not candidate for white laminectomy procedure.

I think this will be a tremendous option for many patients who would prefer minimally invasive procedure instead of a more invasive procedure as well as repeated epidural steroid injection and ongoing opioid treatment.

I therefore recommend that this procedure be allowed and covered by appropriate insurance agencies for the benefit of the patients.

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

As a state representative I interact quite frequently with my constituents and increasingly the discussions center around healthcare. Whether it be the rising costs of insurance plans, the daunting task of understanding and navigating Medicare rules, or finding a way to get a procedure covered for a patient by a health plan, more and more of our populations’ concerns revolve around healthcare. As a state representative I also interact frequently with my colleagues in the Statehouse who are tasked with doing the most for the population with a static or declining budget and, again, healthcare is oftentimes the primary source of concern. Time and time again decisions come down to not what we’d like to be able to do but rather what we can actually do given the budget. It seems to me from my research that this is not one of those situations. While many times the new product or procedure with great promise also carries a significant price tag the PILD looks to actually save healthcare dollars. In the environment that I just described, we need more of these innovations not less. Assuming that the data reveals a product or procedure to be as safe and effective as those procedures currently being offered and covered we should look to find ways to institute and promote them; not perpetually block them.

On the CED process front I’m equally concerned. Given that the CED was designed to allow for data gathering that would allow CMS to make policy decisions I’m not sure why the draft proposal is for yet another study. In my readings, that include a comment from a Venture Capitalist, the overwhelming response looks to be confusion and frustration that the CED process is not being followed. Rather than being a process with a beginning and end it looks to be a continuous cycle of data gathering at the expense of innovation and patient satisfaction. Again, as an elected official, I hear the frustration that the average American has with our systems. Where they are supposed to be transparent and for the benefit of the people, decisions like this, that are contrary to both stated policy and public opinion, serve to undermine the integrity of government. Given the necessity for programs like the CED and the data that exists for PILD we cannot allow that stigma to be attached here.

Therefore on behalf of the Ohioans that I represent, I once again respectfully request that the draft decision be set aside and a full coverage decision be instituted for the PILD procedure.

If I can ever be of any assistance, please do not hesitate to contact my office at 614-466-3485 or by e-mail at Rep15@ohiohouse.gov.

Yours in Service,

Nicholas J. Celebrezze
Assistant Minority Leader
Ohio House of Representatives
Ohio House District 15

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September 27, 2016

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

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

Dear Ms. Syrek-Jensen:

As healthcare providers in an established interventional pain practice we are writing to ask CMS to reverse their draft decision regarding the mild procedure.

Each day we come to work we see the detrimental impact that neurogenic claudication has on patient lives. We hear the stories from patients and family members alike of how frustrating daily living has become. Gone are the days of socializing with friends, enjoying a grandchild's sporting event, or even preparing a simple meal. Here instead are days filled with hours of sitting because of the pain or weakness from this devastating disease. What should be the "golden years" are too many times far from that. Making things worse, is the knowledge that we have (had) something to offer these patients that has been proven to provide improvement in these symptoms but, for some reason, we cannot get approval. We are the ones who have to try and explain why a cost effective, safe and proven procedure is not available anymore. We are the ones who have to look into a patients eyes and help them understand that there is nothing more for us to offer from a system that they've worked their entire lives paying into. We are the ones who get to document the daily decline in quality of life and overall health of our elderly.

Now we come together as a group as the ones who are asking for CMS to do the right thing, to use the evidence that they have to make a decision in favor of national coverage for the mild procedure. We look forward to being the ones to deliver the great news that we can indeed help a patient better enjoy their later years. We respectfully ask CMS to reverse their decision. Thank you and if you have any questions, please feel free to contact us.

Sincerely,

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Dear Ms. Syrek Jensen,

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

During the planning and execution of the MiDAS ENCORE randomized controlled study, I provided statistical support related to all aspects of the study including protocol design, definition of the a priori statistical endpoints and superiority hypotheses, development of the statistical analysis plan, sample size and power calculations, and analysis of the data for reporting and publication.

With respect to efficacy, the MiDAS ENCORE statistical plan was designed to demonstrate superiority of MILD versus the active control at one year, and the results of this follow-up were recently published in the peer-reviewed literature. In this study, MILD was shown to be statistically superior to ESIs for all primary and secondary efficacy endpoints at both six-month and one-year follow-ups. Further, safety was similar between the randomized groups, meeting the a priori study hypotheses.

The MiDAS ENCORE study represents Level I (ref 1,2) evidence in the form of a prospective, randomized controlled clinical trial. Its one-year outcomes included statistically significant results favoring the MILD procedure over the control for its primary endpoint (Oswestry Disability Index) and secondary endpoints including the Zurich Claudication Questionnaire and a numeric pain rating scale. These results were evaluated in the context of minimal clinically important differences, with the conclusion that MILD showed clinically meaningful as well as statistically significant benefits over control for all of these endpoints.

In the Proposed Decision Memo, CMS expressed certain concerns related to the design and results of MiDAS ENCORE. I respectfully disagree with these conclusions. First, CMS has indicated that the sample size of MiDAS ENCORE is too small and “may limit quality and broader applicability of the study results” due to difficulty of interpreting the p-values. While sample size is always an element of data analysis, the p-value is specifically defined to deal with this issue. A significant p-value has the same statistical meaning regardless of sample size: that the data are substantially inconsistent with the null hypothesis (in this case, the null hypothesis is the assumption of no difference in outcomes between randomized groups, which was rejected in favor of MILD). The p-value is simply a probability, and the significant p-values observed in MiDAS ENCORE represent the same conclusion under the design of 302 enrolled patients as they would if the sample size had been 3,000.

In fact, the finding of statistical significance with a smaller sample size can be a strength: the larger the study, the smaller the effect size needed to find significance, which can lead to declaring statistical significance even when the effect is clinically negligible if the study is large enough. In MiDAS ENCORE, this does not happen the statistical significance of the findings is paired with clinical relevance of the effect sizes distinguishing results with MILD from the control group.

The concern is also raised by CMS that use of pain medications was relatively constant over time in both randomized groups, and that “this may be a potential confounder” of study results. This finding, too, is a strength and not a weakness. In pharmaceutical trials, obviously medication is of primary interest and levels of dosing and adherence to prescribed regimens is critical to interpreting the outcomes. Differences in usage of medications can be central to the design of such studies. Nevertheless, even when capturing medications is central to study conclusions, accurately tracking usage is challenging; recording prescribed medications does not correspond well to actual usage due to the persistent problem of nonadherence, a problem which is known to be time-dependent (ref 3). For non-prescription medications the problem is compounded by a lack of formal tracking, leaving the collection of data for these medications up to the memory and willingness of the patient. These issues are particularly challenging among elderly patients, who may have special issues with polypharmacy, medical literacy and simply memory in reporting use (ref 4). Additionally, as medication is necessarily a systemic treatment as opposed to targeted device therapy, it is inherently difficult to assess its effects in a randomized trial of device therapy.

Put another way, in trials of medical devices, medication is not truly an outcome but rather a potential confounder. However, the finding of constant medication usage over the course of MiDAS ENCORE is not a confounder: rather, it is the absence of confounding. As a device trial is principally concerned with the device effect, measuring such an effect is best done under constant conditions. Randomized trials help to provide balance between groups in baseline conditions which may affect study outcomes, such as age, gender and co-morbid conditions experienced by the subject. But randomization cannot control for changing conditions during the study. Medication regimens which may impact study outcomes are a potential type of such change, and medication usage that varies substantially during study follow-up, or that manifests differently between randomized groups, undermines the ability to cleanly assess device effect – because such changes introduce a second source of potential benefit or harm. Separating the confounding effect of medication from the true effect of the device can be difficult or even impossible if medications change substantially over time in a clinical study, and it is therefore preferable analytically for medications to remain relatively constant in device evaluations, as was the case in MiDAS ENCORE. For this reason, many device trials are designed such that medication regimens remain as constant as possible over time, and this expectation can be codified in regulatory guidance as well (ref 5).

CMS also raises a concern about non-responder rates and missingness of data. Any clinical study must confront the issue of data missingness, which is often caused by early withdrawal of subjects due to dissatisfaction with treatment results, and MiDAS ENCORE was specifically designed to address this issue. This was done by determining the reason for subject withdrawal and declaring subjects to be endpoint failures if they withdrew for the purpose of seeking non-study treatment. The fact that the resulting missingness is more common in the control arm than in the MILD arm is further evidence of the benefit of MILD, since fewer subjects left the study to seek alternative treatment.

Finally, CMS cites the need for additional data, both in longer-term evaluation and in a broader population. While additional data is very rarely a bad thing, it should be noted that the best evidence – Level I trial outcomes – is already available in considerable quantities, and was collected under well-controlled conditions sufficient to permit rigorous scientific evaluation. Further investigation is unlikely to alter the conclusions reached in MiDAS ENCORE and can reasonably be undertaken in a commercial setting.

Briefly, then, consideration of the above issues leads to the conclusion that the MiDAS ENCORE study represents scientifically valid and well-controlled evidence demonstrating the benefits of lumbar decompression, specifically the MILD procedure, conducted in a population consistent with CMS guidelines under the Coverage with Evidence Development process. I therefore urge CMS to revise its draft decision to allow for coverage without the requirement for further clinical studies or other additional data.

Scott Brown, Ph.D.
Owner and President
Altair Biostatistics LLC

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Dear Madam or Sir,

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

As a board certified interventional pain medicine physician, I would admit that the treatment for neurogenic claudication due to lumbar spinal stenosis has been challenging due to lack of available treatment options. The development of percutaneous image guided lumbar decompression (PILD) has allowed me and my colleagues to provide new hope and pain relief to our patients. Specifically I am urging you to allow favorable coverage for the PILD procedure as a valid treatment option for patient who do not want to undergo more invasive and risky spinal decompression surgery.

Since its inception, the PILD procedure has accumulated 12 clinical trials, 17+ peer-reviewed articles supporting its efficacy. I was an investigator in the latest MIDAS ENCORE trial let my Drs. Benyamin and Staats.

In my own practice, this procedure has helped numerous patients with spinal stenosis who either chose not to have open spine surgery or are too sick to have surgery. Many of these patients are themselves spine surgeons and their family members who chose not to undergo open laminectomy. I have personally performed over 100 of PILD procedure without complications. The results have mirrored if not surpassed the national study results.

As the nation is battling a war on prescription opioid abuse fueled by unmet treatment options for chronic pain, the PILD procedure is an excellent example of effective alternative to chronic opioids to treat lumbar spinal stenosis. The use of opioid therapy for a largely senior patient population is not only dangerous but ineffective.

The practice of modern medicine can only improve with continued innovation such as the PILD procedure. The government and medicine must embrace such innovation and nurture such ideas into successful treatment options for mankind.

Thank you for your attention!

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

Many of my patients are needlessly experiencing a diminished quality of life because there is a gap in treatment options for lumbar spinal stenosis. We previously had access to this procedure which provided a minimally invasive means of achieving relief. The majority of my patients did well with this treatment and some have returned looking for repeat to be told that it is not available. It has been in excess of 2 years that we have been waiting to offer this once again to our patients.

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The New Jersey Society of Interventional Pain Physicians (NJSIPP) is the New Jersey chapter of the American Society of Interventional Pain Physicians (ASIPP). NJSIPP is an organization that strives to educate physicians about safe, cost effective, high quality interventional pain management techniques and to advocate for and facilitate legislation which will promote access to high quality care for New Jersey citizens. While we have been disappointed in the continued lack of patient access to mild, we supported CMS’ decision to enter it into the CED process with the understanding that this specific, controlled, level I study would provide the data needed for CMS to make a definitive coverage decision. The CED study, designed and approved by CMS, aimed to answer the following questions:

1. Does PILD provide a clinically meaningful improvement of function and/or quality of life in Medicare beneficiaries with LSS compared to other treatments?
2. Does PILD provide clinically meaningful reduction in pain in Medicare beneficiaries with LSS compared to other treatments?
3. Does PILD affect the overall clinical management of LSS and decision making, including use of other medical treatments or services, compared to other treatments?

The most recently completed and published study, MiDAS ENCORE, clearly addressed these questions. The results of the study’s primary endpoint upon 1 year follow-up, were published in the June issue of Pain Physician and indicated statistical and clinically significant superiority of the mild procedure over the control (ESI) in both the primary and secondary validated outcome measurements. 1 Study patients reported improvements in both mobility and pain. The safety of the procedure was also proven to be as safe as the comparator, epidural steroid injections. The questions CMS posed have been answered through the MiDAS ENCORE study as well as through the previous research completed on mild.

NJSIPP supports the research on the mild procedure. We disagree with the recent determination to delay coverage.

To suggest another study be performed is unfair to the investigators that have followed the provided rules.

Entering yet another study would further limit patient access and delay care. The suggested coverage policy is neither rational nor scientific. As providers, it is discouraging and limits our ability to provide patients with effective, low cost, safe treatments.

mild provides Medicare beneficiaries life-altering improvements. It improves mobility and reduces pain, allowing patients to more independently perform tasks of daily living and get back to living life again. The procedure is safe and performed on an outpatient basis, allowing patients to go home the same day without the resources required for extended hospital stays or the need to treat post-procedure complications.

Interventional pain physicians can use this procedure to provide proven, safe, cost-effective, long term, meaningful relief and QOL improvement for the Medicare population. While initial skepticism of a new technique or procedure is expected and healthy, continued denial in the face of significant clinical proof that addresses specific questions regarding effects on CMS beneficiaries is not.

Therefore, on behalf of our membership, and in response to the successful completion of the CMS required CED study, I’d like to request that CMS enact a positive national coverage decision for the mild procedure.

Thank you for your reconsideration and for allowing providers and their societies to take part in this coverage decision.

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Comments on CED process for PILD

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

The MIDAS ENCORE study produced level 1 data in a randomized process, met primary and secondary endpoints, was published, and satisfied the criteria set forth by CMS. Data from the study met statistical and clinical significance with safety compared to an accepted therapy (Epidural Steroid Injections) for Neurogenic Claudication. Mild coverage existed prior to the CED process during which time patient access to the mild has been frustratingly restricted. The decision of CMS to prolong this restriction for another lengthy study is grossly redundant and troubling. It is doubtful that any further study would produce any new or different data, considering the consistency of cumulative study data thus far.

I would therefore urge CMS to reconsider its decision for a further study and open coverage for PILD so that patients can again benefit from this technology.

Wade Wong DO FACR FAOCR
Professor Emeritus of Radiology
Neurointerventional Radiology and Pain Medicine
University of California, San Diego
Past President American Society of Spine Radiology

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

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

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

1. Why are you going against the opinions of the experts in this field? I have gone back and counted approximately 300 comments that have been sent in to you. The overwhelming majority (it appears to be about 95%!!) have been demanding coverage for this procedure. These comments were written by experienced physicians and physician groups that repeat the same message time and time again: mild is safe, it works and their patients need it. Why do you even allow for comments when it appears you just ignore them and make your own conclusions? If there were conflicting views, I would better understand, but when 95% of the doctors are all saying the same thing, shouldn’t you listen to them?
2. If you won’t listen to the experts, perhaps you will listen the Medicare beneficiaries? We, your current Medicare population, worked hard our whole lives and have contributed to the Medicare system. Why are you denying us treatments and limiting our options? We have paid for this program and we deserve to have all viable options available to us
3. Shouldn’t you be spending our tax dollars reasonably? [PHI Redacted]
4. Why do you need more information before you will pay for this procedure? Through my own research and the facts written in these comments, I have found multiple studies that all have the same results: mild is safe and it helps people. Even the ENCORE study, used in this CED process, showed the same results. As many of the physicians are commenting, if you approved this study, why are the results not good enough for you now?

Are you not contradicting your own approval process?
[PHI Redacted] It is your responsibility to give your beneficiaries the best possible medical care. Countless others may not need to go down the path [PHI Redacted] was forced to take it this treatment were allowed. Please, for the reasons listed above, make this treatment available to everyone immediately.

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The MILD procedure should not be subject to further study. It has been shown to be safe and effective. I have performed many of these procedures and it has provided excellent relief to my patients with central canal stenosis with HLF. It greatly improves my patients quality of life, mobility, ability to ambulate, and reduces symptoms of neurogenic claudication. It allows them to walk with less pain, and reduces the use of medications for pain that cause many side effects in the elderly population. More over the CED process was followed, the study outcomes were published and met all primary and secondary endpoints, so full, unrestricted coverage should be granted. CMS now has what they asked for to provide unrestricted national coverage. A beneficial therapy, mild , was taken away from patients for further study, and the study was conclusive. Patients clearly benefit from the procedure and access should be given back us, as interventional pain physicians to treat our patients with symptomatic lumbar stenosis. Patient access has been restricted for over 2 years and they deserve mild as a treatment option. In terms of the proposed ‘Prospective Cohort Study’, it is not only unnecessary but it would serve to further limit patient access to the mild procedure.

Why the Proposed Prospective Cohort study is unnecessary:
Recent CED study, MiDAS ENCORE, produced level 1 data
20,000 patients have been treated to date
12 studies have been completed and published to date covering 668 mild patients
Additional data collected would be lower quality than the ENCORE study data, which was definitive
Study would result in duplicative data and would provide no new insights or data, which is counter to CMS requirements

Why the proposed study is unrealistic:
The proposed prospective cohort study is ill defined, expectations for enrollment are not clear, endpoints are not clear.
Proposed prospective cohort study would be costly to execute in a practice because they require specialized staff, staff training, time for informed consent, multiple follow ups for data collection, etc. In addition, reimbursement of the procedure does not cover these expenses or make it worth the time required.
Clinical studies are a barrier to participate – many patients are not willing to enroll and the study moniker gives them the impression that the procedure is “investigational” and not well studied, which it is untrue and limiting.
To follow this approach will stifle further innovation. CMS is limiting patient access to proven, safe, effective new therapies which will severely limit future innovation for Interventional Pain as well as all Medicare patients. Finally, it is imperative that CMS follow its own process for developing and covering new technologies for its patient base.

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Dear Sir or Madam,

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

In a well-designed 2012 study [Mekhail N, Vallejo R, Coleman MH, Benyamin RM. Pain Pract. 2012 Mar;12(3):184-93.], percutaneous Image-guided Lumbar Decompression demonstrated a reduction in pain, improvement in function and increase in mobility, while decreasing disability throughout a one year follow-up. Improvement was sustained at two year follow-up wherein the treatment proved more cost effective than surgical decompression by nearly three-fold [Udeh BL, Costandi S, Dalton JE, Ghosh R, Yousef H, Mekhail N. Pain Pract. 2015 Feb;15(2):107-16].

Patients can be evaluated for Percutaneous Image-guided Lumbar Decompression when their comorbidities preclude them from consideration for surgical decompression or their surgical risk outweighs the potential benefits. Experience at our center has yielded results which are seen as soon as post-procedural day #1, and continued improvement is realized over the month following treatment. Quite often, this one-time treatment obviates the need for other less efficacious treatments (including repeated epidurals or chronic opioids) and proves even more cost effective than other techniques for decompression [as outlined in the rigorous investigation by Udeh BL et al].

In sum, I hope you will evaluate the 2 year follow-up outcome data in addition to the recent 6-month and 1 year randomized controlled trial data which met statistical and clinical significance to reconsider coverage adoption for elderly patients with lumbar spinal stenosis resulting from ligamentum flavum hypertrophy. With over 20,000 patients successfully treated and 11 rigorous publications showing the effectiveness of Percutaneous Image-guided Lumbar Decompression, the technique is no longer experimental and represents the next step of innovation in the treatment of spinal stenosis.

I appreciate your consideration of these comments, and would invite any opportunity to discuss Percutaneous Image-guided Lumbar Decompression with you further.

Sincerely,
Robert Bolash, MD
Assistant Professor of Anesthesiology
Departments of Pain Management and Evidence Based Pain Research
Cleveland Clinic
Cleveland, Ohio

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

I feel since CMS established the criteria for the benchmarks for the study and those criteria were met that they should follow their own recommendations and approve the MILD procedure. They should not prohibit patients that are not surgical candidates to receive treatment that can improve their quality of life and possibly even avoid or significantly diminish their need for narcotic based therapy.

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

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

MILD is one of those procedures.

However, a critical aspect of commercialization is unrestricted patient access and a mechanism for payment for that procedure or product.

This decision and this decision alone blocks much needed investment that would otherwise be available to enable inexpensive, clinically validated therapies to be available to the healthcare system.

In the value based pricing and reimbursement world we now live, the world looks to CMS and CAG for leadership and smart decisions on therapies. Given rising healthcare costs, your actions and your actions alone now dictate private payors behavior as well as the access of any therapy to the public.

This decision blocks open access to the public by placing an unmovable, impassable boulder on the road to unfettered patient access via unreasonable burdens. Further, given the prior history of an agreed upon RCT and success of that RCT, the decision erodes the credibility of CAG and CED and raises moral questions about the individuals associated with CAG and CED.

Irrespective of this decision, the Coverage with Evidence Development program is intended to develop data needed for coverage for promising therapies. If CMS still denies coverage once the data has been collected through an approved study, then CED is not a viable policy. As a result, the public will advocate for elimination of the policy and defunding of the groups associated with that policy.

Lastly, I understand this is a draft decision and open to public comment. What you are hearing from the public is that a viable decision MUST include open access to patients without the costly burden of a lower grade, duplicate study as a component of that decision.

Otherwise, expect investment to cease and only expensive therapies that raise healthcare costs to be pursued.

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September 30, 20 16

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

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

Dear Dr. Gilbreath:

On behalf of Vertiflex, the manufacturer of the VertiFlex® Totalis® Decompression System (the "Totalis System"¹), I am writing in response to the publication of the above-captioned proposed decision memo. Vertiflex is the sponsor of a prospective. multi-center, double-blind, randomized controlled trial (the "STEPS Trial") evaluating the use of the Totalis System in percutaneous image-guided lumbar decompression ("PILD") versus a sham surgical procedure in patients with lumbar spinal stenosis ("LSS"). The STEPS trial has been approved by the Centers for Medicare & Medicaid Services ("CMS") for Coverage with Evidence Deve lopment ("CED").

In the Preliminary Decision Memorandum, the CMS concludes that the data submitted in support of reconsideration of the National Coverage Determination for PILD is insufficient to warrant expansion of coverage for the procedure outside of CED. Although Yertiflex believes the PILD procedure is safe and effective for its intended use and is reasonable and necessary for Medicare beneficiaries, we agree that evidence from a sham-controlled trial with a 12-month endpoint will provide stronger evidence in support of the procedure than that provided from a study with an epidural steroid injection (ESI) control.

As suggested by CMS in the Preliminary Decision Memorandum, 12-month follow up data from the STEPS trial is expected to be available by Spring 2017. We intend to submit these data to CMS under our CED protocol, and assum ing the results support an expansion in coverage, we plan to submit a subsequent request for reconsideration supported by more robust data than are currently available.

Pending the submission of these more robust data, CMS proposes to extend coverage for PILD under CED to new patients with LSS that are enrolled and followed in a CMS-approved prospective cohort study, provided the investigator(s) overseeing the study completed a randomized controlled trial approved under the current NCD (among other requirements). As the sponsor of the STEPS Trial, we appreciate CMS's willingness to extend coverage for PILD to additional patients with LSS as a way to continue access to this procedure pending a further reconsideration of the National Coverage Determination. Vertiflex understands, however, that it is not required to participate in the extended CED coverage period, and the company shall consider the balance of continued patient access with the substantial resource burden required to continue enrollment, monitoring, and analysis of the clinical trial.

We appreciate your consideration of these comments. Please do not hesitate to contact me if you have any questions or comments. I can be reached at 949.940.1434 or sreitzler@ve1tiflexspine.com.

Steve Reitzler, Vice President, Clinical & Regulatory Affairs
VertiFlex, Inc.

1 The VertiFlex, Totalis™ Decompression System is a set of specialized instruments designed to perform minimally invasive direct decompression of the lumbar spine in patients with lumbar spinal stenosis. This procedure is also known as Percutaneous Image Guided Lumbar Decompression.

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

I feel strongly that a decision to not offer full coverage for MILD is the wrong decision. It will restrict patient options, result in needless surgery for some patients that could improve with a much less invasive procedure, and contribute to more pain and suffering for our aging population.

I implore those making this decision to reconsider the cover policy.

Bryan Hoelzer MD
Assistant Professor of Anesthesiology and Pain Medicine
Mayo Clinic

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Dear Ms. Syrek Jensen,

On behalf of the Medical Device Manufacturers Association (MDMA), I would like to thank you for the opportunity to comment on this draft policy. The Medical Device Manufacturers Association (MDMA) is a national trade association based in Washington, DC providing educational and advocacy assistance to innovative and entrepreneurial medical technology companies. Since 1992, MDMA has been the voice for smaller companies, playing a proactive role in helping to shape policies that impact the medical device innovator. It is in this capacity that we feel compelled to urge CMS to reconsider its draft decision and grant coverage for PILD based on the successful completion of the CMS approved Coverage with Evidence Development (CED) randomized control trial.

Medical device innovation needs to have a clear path to reimbursement so that companies know the investments that are required and investors will continue to support small companies. CED provides a great opportunity for that by defining requirements and supporting necessary data gathering through limited reimbursement. For a program like CED to be supported by medical device manufacturers, though, there needs to be clear objective criteria and a viable exit from CED. This proposed draft policy jeopardizes these objectives and raises significant credibility issues around CED.

In 2014, CMS issued a National Coverage Determination (NCD) for PILD with clear requirements for Coverage with Evidence Development. The MiDAS ENCORE sponsor submitted a protocol to meet these data requirements with clearly defined goals and endpoints, which was approved by CMS. Critical data needed to make a coverage decision should have been part of the protocol approval process otherwise there is no point in investing in a clinical trial that doesn’t result in favorable coverage. The sponsor met all primary and secondary endpoints so there should be a reasonable expectation that the requirements of CED have been met and full coverage should be granted. The draft decision, however, imposes a new requirement for an additional study after requirements have been successfully achieved in the original CED. A policy that requires a new CED after successful completion of the original CED is not viable and a significant deterrent to innovation.

We believe that the CED framework can provide a substantial benefit to innovation but only if it is transparent, predictable, objective, and results in coverage when predefined conditions have been met. In the interest of having a viable CED framework that encourages innovation, we urge you to change your decision to full coverage based on the fact that the sponsor has fulfilled the requirements set by CMS in the original CED. Thank you for your consideration.

Mark Leahey
President & CEO
Medical Device Manufacturers Association (MDMA)

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As you know, most patients facing lumbar spinal stenosis LSS face a compendium of options which are either largely ineffective or fraught with great risk. Most patients in this age category understand their options quite well. Living with the pain and disability is extremely dangerous as disability and the inability to walk portends an early death and increased morbidity shown by literally hundreds of studies over decades of research . Simply stoning this aging group with opioids is also not a reasonable approach for obvious reasons.

The surgical options of laminectomy, fusion and the combination of the two, while potentially curative (and thus the aim of both MILD and PILD) suffer from a very significant a range of complication risk cited cross the literature as somewhere between 20 and 27% through multiple studies. The open approaches carry vastly more surgical risk to the patient and thus more economic risk to the insurer.

There exists an enormous opportunity for a minimally invasive and thus far safer and yet equally effective option and thus percutaneous, micro-invasive lumbar decompression was born: MILD/PILD.
In capable hands, both MILD and PILD are safe and effective. Medicare is aware of the numerous studies, which exist revealing the positive and long-lasting effects of PILD/MILD. Additionally some 12,000 patients join the enrollment registers of Medicare per day. This cohort is largely educated, politically savy and aware of the responsibility of their government to provide reasonable care. PILD/MILD sits on their lips in our waiting rooms, and this group are particularly interested in function. As the head of one such hospital based practice in the epicenter of the problem, South Florida, the solution which you now debate (PILD/MILD) may very well solve this impending financial (for Medicare) and medical problem for my patients.

Please allow coverage of MILD/PILD.

W. Porter McRoberts MD, ABPMR, FAAPMR, ABA
Medical Director, Division Neurosurgery, Interventional Spine and Pain Medicine
Holy Cross Hospital
Assistant Professor, University of Miami, Miller School of Medicine
Fort Lauderdale, Florida

1 Manini T et al. Daily Energy Expenditure and Mortality Among Older Adults, JAMA: Journal of the American Medical Association, 2006, 296(2):171-179. Zheng, H.; Ehrlich, F.; Amin, J. Quantifying the effect size of walking interventions to reduce the risk of coronary heart disease: meta-analysis. International Journal of Body Composition Research . 2010 Supplement, Vol. 8, p51-59. 9p.

Gregg EW. et al. Relationship of Changes in Physical Activity and Mortality Among Older Women. JAMA: Journal of the American Medical Association, 2003; 289(18)2379-2386. Atlas SJ, Deyo RA, Keller RB, Chapin AM, Patrick DL, Long JM, Singer DE. The 8. maine lumbar spine study, part III: 1- year outcomes of surgical and nonsurgical management of lumbar spinal ste- nosis. Spine 1996; 21:1787-1794.

Epstein NE. The frequency and etiology of intraoperative dural tears in 110 pre- dominantly geriatric patients undergo- ing multilevel laminectomy with non- instrumented fusions. J Spinal Disord Tech 2007; 20:380-386.

Ragab AA, Fye MA, Bohlman HH. Sur- gery of the lumbar spine for spinal ste- nosis in 118 patients 70 years of age or older. Spine 2003; 28:348-353.

Tafazal SI, Sell PH. Incidental durotomy in lumbar spine surgery: Incidence and management. Eur Spine J 2005; 14:287- 290.

Khan MH, Rihn J, Steele G, Davis R, Don- aldson WF 3rd, Kang JD, Lee JY. Post- operative management protocol for incidental dural tears during degenerative lumbar spine surgery: A review of 3,183 consecutive degenerative lumbar cases. Spine (Phila Pa 1976). 2006; 15; 31:2609-2613.

Malmivaara A, Slätis P, Heliövaara M, Sainio P, Kinnunen H, Kankare J, Da- lin-Hirvonen N, Seitsalo S, Herno A, Kortekangas P, Niinimäki T, Rönty H, Tallroth K, Turunen V, Knekt P, Härkän- en T, Hurri H; Finnish Lumbar Spinal Re- search Group.Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial. Spine (Phi- la Pa 1976). 2007; 32:1-8.

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

September 25, 2016

Re: MILD/PILD decision

To Whom It May Concern:

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

I supported the direction that CMS offered when deciding to put MILD under the CED process initially as I believed that the study, if successful, would lead to a coverage decision and patient access. Since that time, the published 6-month and 1-year data from the current CMS-approved ENCORE study showed statistical superiority and meaningful clinical improvement in MILD patients when compared to an approved therapy, ESI, and I fully expected this would result in a reversal of the Non Coverage Policy for PILD.

Now, the draft decision forgoes following your own CED procedure and instead requires another lower-quality study. The additional data requested has already been addressed in multiple previous studies with over 20,000 patients treated. Requesting additional data through the proposed prospective cohort study does not add meaningful data and limits patient access to this procedure. As far as I can tell, no other LSS therapies have required access only through a prospective cohort study as a basis for coverage.

I sincerely urge the members of CMS to reconsider national coverage of the PILD procedure without the requirement for the prospective cohort study.

Sincerely yours,

Ronald M. Laub, MD

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Dear Ms. Syrek Jensen

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

Our Interventional Pain Management group at Cleveland Clinic has participated in MILD multi-center studies, and I personally conducted and published our own single-center prospective study on patient outcomes following treatment with the MILD procedure (1,2). Also we published on the cost-effectiveness of options to treat symptomatic lumbar spinal stenosis (3).

As a practicing interventional pain physician and experienced user of MILD, I am confused about the rationale behind CMS imposing another CED study after successful completion of the CMS-approved MILD CED (4), in addition to several other peer reviewed publications on the safety, efficacy and cost-effectiveness of the procedure.
The CMS-approved ENCORE RCT was specifically-designed to provide the high level of evidence required by CMS to make a coverage decision. CMS approved the ENCORE protocol because it met the CED requirements set forth in the January 9, 2014 NCD. Given that, I can not comprehend how could more data with (i) the same selection criteria, (ii) the same follow-up periods, and (iii) the same outcome measures, but conducted in a manner supplying a lower level of evidence, provide an added value to the current level of evidence?

I would also like to point out that the characterization of the CMS-approved ENCORE RCT as having a small sample size with potential confounding factors are not accurate. The study design, including sample size, was based on a strict statistical analysis plan that provided 80% power and the fact that no confounding elements were identified during the course of extensive statistical analyses designed specifically to identify confounders. It is also important to note that the ENCORE study design and statistical analysis plan were approved beforehand by CMS. In addition, the newly suggested non controlled, non randomized cohort study follow up will not answer the issues of sample size or potential confounding elements.

MILD is an effective procedure that provides significant improvements in function and reduction in pain and disability for many patients. The MILD study conducted at Cleveland Clinic demonstrated significant functional improvement as well as decreased disability for patients treated with MILD. Mean Walking Distance increased from 246 to 3,956 feet, and mean Standing Time increased from 8 to 56 minutes (2). Regarding cost-effectiveness, Udeh et al. demonstrated that the MILD procedure is the most cost effective option to treat lumbar spinal stenosis patients in a comparison of MILD, ESIs and laminectomy surgery through two years post-procedure and beyond(3).
Finally, It is my opinion that the MILD procedure in not meant to replace the need for surgical decompression of the lumbar spines in patients with symptomatic lumbar spinal stenosis. On the contrary, It improves functionality, provides pain relief and decreases disability in lumbar spinal stenosis patients who are refusing surgery or considered high risk for surgery. It is a unique minimally invasive and cost effective option (3 & 5), that fits the concept of population management in a nation where 10,000 of us crosses the age of 65 years every day!!!!

On behalf of innovation and the credibility of the CED process, I encourage you to change this decision and offer coverage to all patients with symptomatic lumbar spinal stenosis without requiring another CED.
Thank you for considering this request.

Nagy Mekhail, MD, PhD

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Thank you for the opportunity to comment. I am the MiDAS ENCORE principal investigator and paper author along with my colleague Dr. Peter Staats. I am shocked by this decision and ask CMS to change their position to a coverage decision without the need to do a prospective cohort study. The CED process is intended to develop evidence to support a coverage decision. This was done with MiDAS ENCORE…a protocol that was approved by CMS. Success should be determined by achievement of a priori endpoints. This was clearly done for the MiDAS ENCORE study. When combined with the multiple publications and studies done prior to CED, CMS should have sufficient data to determine whether a treatment is reasonable and necessary. The significant statistical superiority on all primary and secondary endpoints are a testament to this. A policy system that sets criteria for coverage and then changes those criteria after successful achievement of endpoints creates a huge problem for innovation. Statements like “high non-responder rates”, “small sample”, etc. should be based on a standard set during protocol development. This was not done. Instead, clear definitions of success were determined and achieved. This means that based on best clinical practices, the data is sufficient.

The recommendation for only allowing patients to be treated in a prospective cohort study is a significant access limiter. The requirements for the study also appear to be exactly the same as those for MiDAS ENCORE (same patient inclusion, same endpoints, etc.). It begs the question as to what we are trying to achieve since data generated will be a duplicate of data generated during MiDAS ENCORE.

As principal investigator I was very aware of the effort it took to enroll the study. It does not appear that your proposed cohort study has any easier enrollment criteria. It would be exceedingly difficult to find practices that would be willing (and able to do this)...especially given the low reimbursement for this procedure. This study proposal is a significant barrier and will not result in improved outcomes.

Finally, it is shocking that this is the level of evidence that is required to determine “reasonable and necessary”. I am not aware of any interventional pain procedure or spine surgery that limits coverage to only patients enrolled in cohort studies after success has been determined in an RCT. Even the FDA doesn’t typically do this after a successful RCT…the most they would demand is a post approval study to study a very specific issue. The CMS position is extreme. This is especially tragic given that this procedure can benefit so many that have very limited treatment options. It has been proven to be extremely safe and efficacious. Equally important, it is inexpensive and has been demonstrated in the Wang study (which you cite) and the Udeh study (see source) as significantly saving health care dollars.

The proposal will not create more access and because of that it is difficult to contemplate that this therapy can continue to exist in the market. We may very well be in a position where a very good & proven therapy fails because of an unreasonable requirement. I urge you to create true access to this therapy by granting coverage without the need for enrollment in a study based on the strength of the CED CMS study and the other 11 studies that have been performed on this procedure. Thank you.

Source
Belinda L. Udeh, et al., “The 2-Year Cost-Effectiveness of 3 options to Treat Lumbar Spinal Stenosis Patients”, Pain Physician, 2014

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

When CMS initiated the “Reconsideration Process” for the current Non Coverage Policy for PILD on April 13, 2016, and after reviewing the published 1-year outcome data on the CMS sponsored CED ENCORE study, I fully expected that a reversal of that policy would transpire and a Full National Coverage Policy would replace it.

The current “Proposed Decision Memo” unfortunately does not meet those expectations. In the memo, you state: “We believe that the new evidence supports border coverage under CED.” However, if this draft proposal were to be approved, it would actually only further hinder qualified patients from having access to this therapy. Although prospective cohort studies may be useful for some unproven therapies, the mild procedure (PILD) does not fit in this category because it already proven to be safe and effective clinically (11 other published studies) as well as commercially (20,000 patients already treated).

In fact, the CMS sponsored ENCORE CED study is a level 1 study that clearly met all of your designed endpoints and already answered the questions which you are now proposing:

1. Does PILD provide a clinically meaningful improvement of function and/or quality of life in Medicare beneficiaries with LSS compared to other treatments?
2. Does PILD provide clinically meaningful reduction in pain in Medicare beneficiaries with LSS compared to other treatments?
3. Does PILD affect the overall clinical management of LSS and decision making, including use of other medical treatments or services, compared to other treatments?

The creation of another study/cohort/registry would only produce duplicate proven outcome data and add extra time and cost to the patient, physician, staff and the CMS healthcare system as a whole. Furthermore, the cohort study you are proposing is not only redundant, but it seems to lack any specific, clearly defined outcome endpoints.

Lastly, I have been a Board Certified Pain Management Specialist for many years. I cannot recall any therapy that has been so thoroughly studied, yet so slow to gain CMS approval. I don’t recall any of our currently approved LSS treatments having to go through a prospective cohort study as you are suggesting here.

Based on the already overwhelming evidence for PILD, I strongly recommend that this “Proposed Decision Memo” not be adapted and instead approve a policy that would allow all qualified patients be able to receive this therapy and not restrict it only a limited number involved in yet another clinical study. Many patients have been denied access to this therapy for several years and the data is there to support a policy decision that provides them access to adequate treatment. I therefore respectfully ask that CMS retracts this draft decision and instead institute a Fully Covered NCD for PILD.

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The West Virginia Society of Interventional Pain Physicians (WVSIPP) is dedicated to providing cutting edge education, information and support to physicians and clinicians treating patients in pain. We are a West Virginia society with national and international reach and we are a certified and sanctioned branch of the American Society of Interventional Pain Physicians (ASIPP). Our board members include international thought leaders in interventional pain management and physical medicine and rehabilitation. We would like to thank CMS for the opportunity to comment on this proposed coverage policy for the mild® Procedure and respectfully ask CMS to seriously reconsider their recommended coverage policy and instead provide full open national coverage for the mild® Procedure.

WVSIPP has continuously supported the mild Procedure over the last 8 years and our members have shown ongoing support throughout the CED process by posting comments during the public comment period as well as having several members participate in the recent CED study (MiDAS ENCORE). Our board and members have also served as investigators in previous studies and have served as physician trainers, educators, etc. to support the adoption, ongoing research and education of mild. This therapy is unique and powerful. We strongly believe that continuing to limit patient access is unnecessary and unreasonable.

The mild Procedure is well studied and the evidence exists to support full coverage. The therapy has been proven to work in the clinical trial setting as well as in general practice. It is extremely safe and effective. Patients are able to stand longer and walk farther with less pain. We see this demonstrated over and over in the published literature as well as in our own practices from our own patients. Patients report an improvement in the quality of life measures and it is achieved with an extremely low complication rate. (reference 1-11)

Asking for another study at this point is not necessary. The clinical data from numerous, published exists and fully supports a positive decision, but additionally, the data collection you are requesting through a Prospective Cohort Study would result in lower quality data that replicates what already exists. This sort of study would limit patient access, be very costly and would provide extremely little value to the treating community of physicians awaiting access to a therapy that can significantly improve their LSS patients’ condition.

The CED process was followed and the results of the MiDAS ENCORE study prove not only that mild works, but that it is clinically and statistically more effective than current available interventional therapies (reference 1). Halting access to proven innovations seems illogical and impractical. As providers we constantly strive to provide better, higher quality, and more cost effective care for our patients, which we believe aligns well with CMS’ mission mild is a shining example of the type of care we need to fulfill this mission. The research is there and the providers, the recognized leaders in interventional pain treatment, are in strong support of this long-scrutinized therapy. It’s appropriate now to reconsider this policy and lift the limitations you have set, providing patient access to this effective safe therapy. Thank you

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

There is no need for another study. There have already been 12 studies all showing efficacy and the ENCOre study met all the end points. Another study will not add any more information that we don't already have. No more studies!

Lets get this procedure back into providers hands so we can help our patients!

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I am a Board Certified, Fellowship Trained Pain Management specialist with approximately 25 years of experience, with significant experience treating low back pain. I am writing to give support for CMS to cover for the MILD procedure, rather than mandating a redundant RCT, which will not add significantly to the published body of knowledge regarding the efficacy of MILD procedures for patients with painful spinal stenosis. The prior study mandated by CMS supported multiple previously published studies that proved that the MILD procedure is both safe and effective. Mandating another multi-year trial will lead to a significant number of patients suffering needlessly.

Alternatives for treating this type of pain are frequently not as effective, more costly, and fraught with additional risks. Epidural steroid injections have very limited long term potential benefits, since inflammation may be only a minor component to the stenosis forces. Medications are typically with limited efficacy, and higher risks of adverse reactions. Opioids are problematic on multiple fronts, in addition to the fears of abuse, dependence, and addiction. In the population impacted most by spinal stenosis pain, there are added concerns of interaction of multiple other medications, confusion and falls. The MILD procedure offers a safe and effective approach to address the actual pathology, and allow reduction of reliance on opioids and other medications. Given the new regulatory issues on opioid use, treating chronic pain is becoming much more difficult for all causes. We have the opportunity to make a very real impact on chronic low back pain, if only allowed to use this very effective tool.

Another study would serve only to inhibit treatment to a large number of patients, without adding to the body of knowledge on the MILD procedure. Therefore, I urge that this procedure be covered by CMS, rather than mandate a redundant and relatively meaningless clinical trial.

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Patients with severe spinal stenosis caused by ligamentum flavum hypertrophy have woefully few options to relieve their pain and disability. The neurogenic claudication symptoms of SS significantly limits mobility leading to increased utilization of mobility devices such as canes, walkers, and wheelchairs. Currently these patients suffer a slow and painful course leading many to opt for major surgery which is replete with risk. I have performed the MILD procedure on over 25 patients and I can say without reservation that if I myself or any of my loved ones were unfortunate enough to suffer with SS I would elect for a MILD procedure to be done in competent hands before electing for open surgery. The only other option to surgery or MILD is to suffer. Epidural injections offer no lasting relief in severe spinal stenosis and pain medications often cause too many side effects in the elderly.

In fairness I would say that the technical skills and views involved with proper performance of the MILD procedure under fluoroscopy are not commonly used in interventional pain management. A certain number of mandated training hours should be considered for doctors interested in performing the MILD procedure.

Please reconsider your decision to require another study and allow the MILD procedure to be covered when performed by qualified practitioners. There are millions of people suffering with this condition and they deserve additional options.

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As stated in our previous comment, our Society of Interventional Pain Physicians supports the process of researching and validating novel technologies to provide the safest, most clinically effective, least invasive, and most cost effective procedures and treatments for our patients. We appreciate the opportunity to comment on the proposed decision memo, or draft coverage policy for the MILD Procedure. The mild procedure has a large body of high quality research that demonstrates the safety and effectiveness in the treatment of patients with lumbar spinal stenosis with neurogenic claudication symptoms.(1-12) As such, we would like to recommend that CMS re-evaluate their position and develop a revised policy that expands patient access in the form of national coverage for the mild procedure.

The CED process was followed and the data proved mild superiority, therefore full coverage and patient access should be granted. The latest study (MiDAS ENCORE) was required by CMS as part of the CED process and provided Level 1 clinical evidence of improvement in both physical function (as measured by ODI and ZCQ Physical Function subdomain) and pain (as measured by NPRS and ZCQ Pain subdomain). The outcomes were statistically and clinically significant and superior to the comparative therapy; ESIs.1 In addition to this high quality study, mild has been well researched in a total of 12 studies and in dozens of peer-reviewed clinical journal articles. There have been no major complications related to the device or the procedure reported within any clinical trial. The recent MiDAS ENCORE study also reported no statistical difference in safety endpoints between mild and epidural steroid injections. To have a treatment that is effective AND as safe as an ESI is encouraging and an ideal fit for this suffering patient population.

While we encourage and support ongoing research of all therapies, suggesting coverage only be available within yet another clinical trial is unnecessary and is unfounded. Allow us as physicians to provide quality care to our patients who are demanding safe, proven therapies like mild and continue the ongoing research of this therapy on our own. If your study requirement is not lifted, the data you are requesting would be low quality and repetitive of what exists—this would not be valuable to us as providers or to the patients we serve. Please reconsider your position and do not limit patient access any longer. As a specialty, we will continually study the therapy (as we do with all of our treatments) but do not limit patient access and our ability to provide high quality treatments in the meantime. It is unnecessary as providers we strongly believe this is unethical.

Medicare patients have a real need for procedures that minimize risk and provide a more than reasonable chance of reduced pain and improved quality of life. We believe there’s a robust body of evidence that supports that and, therefore, we support a positive coverage decision for the mild procedure. We thank you for giving us the opportunity to comment.

Christopher Gharibo, MD
Medical Director of Pain Medicine, NYU Hospital for Joint Diseases
President, New York Society of Interventional Pain (NYSIPP)

1. Benyamin, R., et al. (2016), mild® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial, Pain Physician, 19: 229-242, ISSN 1533-3159.
2. Staats, P., et al. (2016), MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results, Pain Physician, 19: 25-38, ISSN 1533-3159.
3. Mekhail, Nagy, et al. (2012), Functional and Patient-Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression. Pain Practice, 12(6): 417–425. doi: 10.1111/j.1533-2500.2012.00565.x
4. Mekhail, Nagy, et al. (2012), Long-Term Results of Percutaneous Lumbar Decompression mild® for Spinal Stenosis. Pain Practice, 12(3): 184–193. doi: 10.1111/j.1533-2500.2011.00481.x
5. Brown, Lora L. (2012), A Double-blind, Randomized, Prospective Study of Epidural Steroid Injection vs. The mild® Procedure in Patients with Symptomatic Lumbar Spinal Stenosis. Pain Practice, 12(5): 333–341. doi: 10.1111/j.1533-2500.2011.00518.x
6. Chopko, Bohdan (2013), Long-term Results of Percutaneous Lumbar Decompression for LSS: Two-Year Outcomes. Clinical Journal of Pain, doi: 10.1097/AJP.0b013e31827fb803.
7. 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
8. Deer, Timothy, et al. (2012), Study of Percutaneous Lumbar Decompression and Treatment Algorithm for Patients Suffering from Neurogenic Claudication. Pain Physician, 15(6): 451-460, ISSN 1533-3159.
9. Chopko, Bohdan W. (2011), 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. Journal of Neurosurgery: Spine, 14(1): 46–50.
10. Deer, Timothy, et al. (2011), Minimally Invasive Lumbar Decompression for Spinal Stenosis. Journal of Neurosurgical Review, 1(S1): 29-32.
11. Chen, Hamilton, et al. (2012), mild® Procedure for Lumbar Decompression: A Review. Pain Practice, 2013; 13(2): 146-153 doi:10.1111/j.1533-2500.2012.00574.x
12. Deer, Timothy. (2012), Minimally Invasive Lumbar Decompression for the Treatment of Spinal Stenosis of the Lumbar Spine. Pain Management, 2(5): 457-465, ISSN 1758-1869.

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

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

While the MILD procedure had coverage, I performed about 75 MILD procedures with excellent results. I still have patients who are friends of those who had the MILD procedure ask about it. I found the MILD procedure to very effective with no recovery time and no adverse effects.

While I understand the need for statistics in studies, they don’t always have much meaning to us practitioners. What is important to me is how my patients do after a procedure. They are not a statistic. I want to be able to provide the best treatments available to improve their quality of life. The MILD procedure allowed me to do this. When it became no longer available, it markedly diminished my ability to take care of these patients. I see patients everyday with ligamentous hypertrophy who would benefit from the MILD procedure.

I have read the studies, including that last one required by CMS. I don’t see how another study would help to clarify anything. All it would do would be to restrict patients from receiving this valuable procedure.
For the vast number of patients who would benefit from the MILD procedure, I would ask for a positive National Coverage Determination.

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I am providing comments regarding CMS’s recent draft coverage proposal for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R). This procedure has recently been studied through the CMS CED process as outlined by CMS and agreed to by CMS. Despite excellent study results CMS has not granted coverage (or even coverage with specific restrictions) delaying and denying access to this important minimally invasive treatment for patients. Candidates for less invasive spinal stenosis decompression will be forced to undergo more aggressive, invasive and riskier surgery. This will lead many of these individuals who do no not want or cannot have aggressive spinal surgery because of other co-morbidities to be placed on chronic opioid medications with all the inherent risks and complications especially in this elderly population.

This therapy was available prior to the CED process and helped thousands of patients but for 2 years now patients have been denied access to this important minimally invasive therapy. The manufacturer cooperated fully with the CED process and the CED Study, MiDAS ENCORE, met statistical and clinical significance compared to an approved therapy (ESI) across all endpoints. Despite complying with CMS fully, demonstrating appropriate and positive outcomes CMS has now proposed a prospective cohort study which is not only unnecessary, but unrealistic and would further limit patient access to the mild procedure. The proposed policy will instead promote opioid usage and is in contradiction to recent CDC and FDA guidelines which urge the use of non-opioid therapies as first line care for chronic pain.

Today the data exists to support national coverage of mild including the CED study, MiDAS ENCORE, which produced level 1 data and which makes a total of 12 studies completed, 17+ peer-reviewed clinical journal articles published and 20k total patients which have been treated to date. The costs of additional studies are significant and at this juncture possibly prohibitive at this point for a start-up company trying to bring a new product to market. I fear that the current decision, which seems to ignore not only the extensive evidence to date, but the proposed CED process, will stifle innovation far beyond this one procedure. Who will want to bring a new product to market if the barriers to coverage are unreasonable and the coverage bar constantly moving?

The decision to not provide coverage for mild is shortsighted and will ultimately result in greater costs to the health care system by shifting patients to more expensive and less effective therapies. The existence of another study does not lead to access for patients as the study sites are limited, geographically isolated, and many patients simply don’t want to participate in a research study even for a well-studied product such as mild because of all the extra effort and pt. time required for study participation; most patients also don’t like to participate in medical studies as it gives them the impression that the treatment is investigational and not well studied which is not the case for this therapy.

CMS recent draft coverage proposal for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R) will limit patient access to a proven, safe, and effective new therapy which will have significant negative repercussions for all innovation not just in Interventional Pain but for all new Medicare therapies. The CED process was followed, CMS approved the study protocol and endpoints, the CED study outcomes were published and all study endpoints were met, so there appears to be little rationale for CMS to not provide national coverage. CMS must follow its own process for developing and covering new technologies for its patient base, if not what hope is there of anyone being willing to try and develop new and better technologies in this market?

I would strongly urge CMS to reverse this proposal and provide coverage for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis with specific restrictions consistent with the evidence that has been developed as it relates to patient selection. This will ensure patient access to this extremely helpful minimally invasive therapy and will provide patients with an option to aggressive conventional surgery and long term opioid usage.

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Dear CMS Committee Evaluators:

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

I implore you to make appropriate & sensible decisions so that appropriate patients are NOT barred from receiving this beneficial & necessary procedure.

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

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

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

Lobbying by spine surgical companies is the only reason I believe that MILD procedure is being held up at CMS.

I am disappointed with CMS handling MILD procedure appovals, but not surprised.

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To whom it may concern:

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

This procedure is a Godsend especially for the elderly who cannot have a surgery due to concominant medical health issues destining them to narcotics and wheelchairs.

Asking for more and more proof that this procedure is worthwhile is just delaying treatment for these many thousands of patients.

Please reconsider and allow Medicare payment NOW!

Thomas G JOhans, MD

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mild is a minimally invasive interventional pain procedure which has helped thousands of patients will very minimal risk. To date there have been several studies documenting its safety. In 2016, a study was published documenting its superiority to epidural steroid injections for lumbar spinal stenosis. Epidural steroid injections are performed every single day for stenosis but we need additional treatment options. I have personally performed mild prior to the CMS ruling and had excellent results without a single complication. mild allows for improved patient outcomes vs. epidural steroids without exposure to steroids.

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I’m writing on behalf of the California Society of Interventional Pain Physicians (CASIPP) and asking that CMS reconsider its recently posted draft decision on the mild® procedure. As an active participant throughout the CED process I’ve read the draft and find myself wondering what exactly CMS is doing. I’ll admit that while disappointed in the initial decision to put mild into the CED process, as I’ve seen first-hand the positive effects that the procedure can have a patient’s quality of life, I understood the request for a comparative outcome study to supplement the other available data for CMS to make a definitive decision. Given that the CMS approved ENCORE study met clinical and statistical significance when compared to the approved therapy and the prior-approved 1-year timeline was met, it seems that CMS has what it needs to render a coverage decision. Asking now for lesser quality, “real world” patient data is repetitive as it will only result in data already available from the numerous previous studies and will serve to continue to limit access to patients suffering from the effects of neurogenic claudication due to LSS. I implore CMS to reverse this decision and grant full coverage for this proven therapy.

Joseph A. Cabaret, MD
President; California Society of Interventional Pain Physicians

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

I have treated over 100 patients with MILD and have seen the benefits of this therapy in my patients. I am writing to request that you change this policy to a positive coverage policy without the requirement for a prospective cohort study. Your proposed prospective cohort study is limited to investigators from the CMS RCT study, which greatly restricts the number of physicians that can offer the procedure. This limits patient access to a proven therapy.

I am dismayed that CMS feels that the body of evidence for MILD from multiple studies in addition to the CMS approved RCT did not provide sufficient data to make a coverage decision. Particularly given alternative much more aggressive therapies that these patients are left to consider clearly have a significant greater risk, expense with much poorer long term outcomes.

I thought the whole point of CMS approving an RCT was to answer the key questions they needed answering. Based on my reading of the article by Drs. Staats and Benyamin, the defined endpoints were met and showed significant statistical superiority over the control. Surely this demonstrates that the therapy works, is safe and should therefore be available to more patients. Add to that the fact that this procedure is very inexpensive and the Wang study you cite shows that it reduces health care costs. This should make it a procedure that CMS should want to be available to their beneficiaries!!!

There is no way that a study can answer every question…that is not how clinical studies work. Denying access because every single possible question has not been answered places an unreasonable burden of proof for this therapy that already has so much proof.

I am not aware of any similar procedure (or more expensive spine surgeries!) that requires participation in a cohort study as a condition for getting reimbursed!

There is an urgent need for a lumbar spinal stenosis treatment for the elderly that is safe, effective, and inexpensive. MILD addresses this need very well and the latest RCT clearly shows that it should be considered reasonable and medically necessary.

I urge you not to continue to restrict the access. Of the over 100 patients under my care with MILD, over 90% are functioning better & none experience any complications or unwanted negative consequences of the procedure. It’s a simple, very safe & certainly relative other available treatments, the clear choice for management of symptomatic lumbar stenosis with neuro deficit.

Don’t play politics. I urge you to do the right thing. This should be a very simple decision in favor of MILD. The data clearly speaks for it self.

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

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

This decision is deeply concerning. It is unreasonable and without precedent. It creates an impossible set of standards that either 1) unfairly apply just one procedure or 2) will apply universally to all new procedures. If it is the latter, future investment in medical technologies will diminish considerably. ( Although I believe it is most likely the former reason and CMS is allowing itself to be corrupted )There will be very little true innovation – only incremental progress that purposefully avoids any designation as “new” or “novel.”

Please consider the broader implications of a decision like this. I can’t imagine that the value of additional data outweighs the potentially dramatic cost of halting major advances in patient care.

C. Lan Fotopoulos, MD
Interventional Spine and Sports
Dickson-Diveley Midwest Orthopaedic Clinics.

Board Certified Physical Medicine & Rehabilitation
Board Certified Pain Medicine
Board Certified Undersea & Hyperbaric Medicine
Board Certified Sports Medicine

Certified and Trained in Age Management Medicine by Cenegenics

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

Weakness of a Prospective Cohort Study (PCS):
The execution of a PCS is expensive, time consuming and challenging to enroll. The MILD Procedure is not reimbursed sufficiently enough to support the absorption of the costs required to set up, enroll and manage a clinical study. IRB fees alone would discourage most sites from participating. Patient enrollment would be difficult for numerous reasons, but mainly because patients desire safe therapies that work, and when presented in this manner, the MILD Procedure would appear to be investigational, which clearly is not the case. The procedure has already been proven as safe and effective in several published peer-reviewed clinical journal articles as well as in everyday practice.

Lower Quality Data: The Midas Encore Clinical Trial provided Level 1 data that met all primary and secondary endpoints.¹ According to the CED process listed on the CMS website, CMS assisted with and approve the design of the study and since all end points were met, coverage should be provided. The suggested PCS would provide lower quality data than what exists. If the same patient selection criteria is used, as suggested, it would duplicate existing published data. In addition, the suggested study endpoints are unclear, potentially leaving providers in an endless cycle of clinical research. This is unrealistic, undesirable, and does not present clinical best practices. A PCS will not add value to the clinical data compendium that exists and will ultimately negatively impact patient care. In addition, the Encore trial results mirrored previously published outcomes from different practitioners in different institutions; thereby validating prior investigators’ work. In essence, this retrospectively increases the effective population size of MILD related subjects. Initiation of another study adds to this redundancy and prolongs the availability to ailing patients that may benefit from it.

Limiting New Technology: As I believe it is intended, the CED process should provide a clear path for new technologies to be studied, evaluated and covered. If the therapy is evaluated and proven to be safe, effective and valuable for the Medicare patient population, full access should be granted. The process suggested for the MILD Procedure does not follow the above process. Its safety, effectiveness and value has been proven in clinical trials as well as in general practice. Asking for additional, lower quality data will limit both access and the amount of new technology activity in the future. This process is discouraging for the Medicare patient population and providers. We do not want to create a culture where emerging, proven technologies are limited, leaving patients with fewer options to optimize their care.

The history of the MILD Procedure and the data available gives physicians, patients, and CMS what they need to clearly understand the role of the MILD Procedure.as a beneficial treatment option for Medicare patients suffering with LSS. The appropriate patient selection criteria has been defined, the therapy has been proven over and over to be safe and effective and we understand where it fits in the treatment of LSS. This CED and continuing research process is disruptive to our practices and is limiting access to patients who deserve the MILD Procedure as an option for treating their lumbar spinal stenosis (LSS).

Thank you reviewing my comment. I urge CMS to rethink what has been presented, and instead grant national coverage of the MILD Procedure.

1. Benyamin, R., et al. (2016), mild® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial, Pain Physician, 19: 229-242, ISSN 1533-3159.
2. Staats, P., et al. (2016), MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results, Pain Physician, 19: 25-38, ISSN 1533-3159.
3. Benyamin, R., et al. (2015), MiDAS ENCORE: Randomized Controlled Study Design and Protocol. Pain Physician, 18:307-316, ISSN 1533-3159.

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Dear Ms. Syrek Jensen,

My name is Peter Staats and I am a board-certified physician specializing in pain medicine. I also serve as an Adjunct Associate Professor at Johns Hopkins University School of Medicine where I was the founder of the division of pain medicine. I am the author of over 200 articles, book chapters and abstracts on the science of pain medicine. I have authored or edited 7 books on pain management. I am one of the principal investigators for the CMS Study for Vertos Medical (MiDAS ENCORE) and co-author of the 6 month and 1 year results for that study (1-3). I want to thank you for the opportunity to comment on the draft policy and express my strong disagreement with your decision. I would encourage you to reconsider and offer coverage without the need of a prospective cohort study.

In 2014 CMS laid out the requirements for a randomized control study (RCT) under its CED policy with the intent of developing high quality data needed to make a coverage decision. The MiDAS ENCORE protocol stipulated a sample size to enable an 80% power, which was accepted by CMS. CMS also agreed on the primary and secondary endpoints at 1 year. It is, therefore, surprising to see that your group concluded that the study “small sample size and short duration”. I strongly disagree with this statement and believe it does not reflect that the endpoint timeframes and sample size were approved by CMS. You also indicate that “we do not know whether the missing post-operative information would have altered the study results”. I do not know what missing post-operative information you are referring to but I do know that extensive statistical analysis and sub-analysis were performed to look for potential confounding elements and none were found. In the end, this was a large study, with a CMS approved protocol, that showed overwhelming statistical superiority and clinical significance on all primary and secondary endpoints (p< 0.001 for almost all endpoints). This study clearly and conclusively demonstrated efficacy using the commonly accepted clinical study guidelines.

I am very troubled by the CED process as it is relates to this procedure. The practice of medicine depends on innovation and a predictable process that sets requirements for the coverage of innovation. In this case, a study was approved with the intention of gathering the necessary data for a coverage decision. The study was completed successfully but there now appears to be new requirements with no clear path to coverage resolution. This makes it very difficult for my colleagues and I to continue to engage in research in the hopes of providing promising treatments to our patients in the future. In addition, research will be stymied by small companies, if there is no clear path to approval.

The suggestion to do a prospective cohort study is also troubling since it is not clear what it is intended to accomplish. A desire to see results in “real world” setting does not mirror the requirements laid out in the prospective cohort study. The patient selection criteria and data collection are exactly the same as the MiDAS ENCORE study so it is difficult to see how this study would add to the body of evidence. As a matter of fact, it appears that the study would violate the requirement in your Decision Memo that “All CMS-approved clinical research studies must adhere to the following standards of scientific integrity and relevance to the Medicare population: The study results are not anticipated to unjustifiably duplicate existing knowledge.” The prospective cohort study would be duplicative of the MiDAS ENCORE study and the numerous other studies that have been published (4-18).

Additionally, the prospective cohort study requirement following on the heels of a successful RCT is a higher standard of evidence requirement than any other covered lumbar spinal stenosis including fusions, endoscopic surgery, and interventional procedures, which is at odds with a therapy that is safe, effective, and inexpensive. As Wang and Udeh have demonstrated, this is a procedure that saves the health care system money…even as far out as two years (19,20). The cohort study would require a practice to conduct informed consent, get IRB approval, have research staff on hand, conduct thorough follow up visits, and track patients. The total reimbursement for this procedure is less than $3500 in the ASC setting and participating in a study cost prohibitive unless CMS dramatically increases the reimbursement amounts. I believe that the vast majority of my colleagues would not be able to participate in this study, which would restrict access to care for patients.

As an interventional pain physician I see the urgent need for this treatment for my patient population. There are many patients that aren’t candidates for surgery (by choice or by necessity) that have extremely limited options. I have treated these patients when the product was available for reimbursement in 2013 and have seen the dramatic improvements that patients experience with this therapy. I have also experienced the frustration of being unable to offer them this therapy as an option. This is an effective treatment that saves money. I am extremely concerned that the policy in its current form is untenable and would result in severe patient access issues and possibly the elimination of this therapy in the market.

Finally, in this era where we as a country are concerned with opioid abuse and addiction, your decision to not cover this outside of a study will lead a large number of patients to receive opiates for their unrelenting pain. Our goal should be to minimize the use of opiates, not force patients with uncontrolled pain to go on opiates. When we have a safe and effective procedure in the PILD, withholding this as an option will further our crisis around opiates in America.

For these reasons, I would ask you to issue a coverage decision without a cohort study requirement based on the data of the CMS approved CED Study and the body of evidence of more than 20+ peer reviewed articles on this therapy. I want to thank you for your consideration.

Peter Staats, MD MBA
Immediate Past President, American Society of Interventional Pain Physicians
Adjunct Associate Professor, Department of Anesthesiology and Critical Care Medicine
Johns Hopkins University

Sources:

1. Benyamin RM, Staats PS. MiDAS ENCORE: randomized controlled clinical trial report of 6-month results. Pain Physician 2015; 18:307-316.
2. Staats PS, Benyamin RM. MiDAS ENCORE: randomized controlled trial report of 6-month results. Pain Physician 2016; 19:25-37.
3. Benyamin RM, Staats PS. MILD is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE randomized controlled trial. Pain Physician 2016; 19:229-242.
4. Mekhail, Nagy, et al. (2012), Long-Term Results of Percutaneous Lumbar Decompression mild® for Spinal Stenosis. Pain Practice, 12(6): 184–193. doi: 10.1111/j.1533-2500.2011.00481.x
5. Chopko, Bohdan W., et. al. (2010), MiDAS I (mild® Decompression Alternative to Open Surgery): A Preliminary Report of a Prospective, Multi-Center Clinical Study. Pain Physician, 13:369-378, ISSN 1533-3159.
6. Mekhail, Nagy, et al. (2012), Functional and Patient-Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression. Pain Practice, 12(6): 417–425. doi: 10.1111/j.1533-2500.2012.00565.x
7. Brown, Lora L. (2012), A Double-blind, Randomized, Prospective Study of Epidural Steroid Injection vs. The mild® Procedure in Patients with Symptomatic Lumbar Spinal Stenosis. Pain Practice, 12: 333–341. doi: 10.1111/j.1533-2500.2011.00518.x
8. Wong, Wade H. M. (2012), mild® Interlaminar Decompression for the Treatment of Lumbar Spinal Stenosis. Procedure Description and Case Series With 1-year Follow-up. Clinical Journal of Pain, 28(6):534-538.
9. Chopko, Bohdan W. (2011) 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. Journal of Neurosurgery: Spine, 14:46–50.
10. Basu, Sanghamitra. (2012) mild® Procedure: Single-Site Experience Prospective IRB Study. Clinical Journal of Pain, 28: 254-258. doi: 10.1097/AJP.0b013e31822bb344.
11. Deer, Timothy, et al. (2012), Study of Percutaneous Lumbar Decompression and Treatment Algorithm for Patients Suffering from Neurogenic Claudication. Pain Physician, 15: 451-460, ISSN 1533-3159.
12. Lingreen, Richard, et al. (2010), Retrospective Review of Patient Self Reported Improvement and Post-Procedure Findings for mild® (Minimally Invasive Lumbar Decompression). Pain Physician, 13:555-560, ISSN 1533-3159.
13. Deer, Timothy, et al. (2010), New Image-Guided Ultra-Minimally Invasive Lumbar Decompression Method: The mild® Procedure. Pain Physician, 13:35-41, ISSN 1533-3159.
14. Chopko, Bohdan (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].
15. 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
16. Schomer, Donald, et al. (2011), mild® Lumbar Decompression for the Treatment of Lumbar Spinal Stenosis. Neuroradiology Journal, 24(4): 620-626.
17. Deer, Timothy. (2012), Minimally Invasive Lumbar Decompression for the Treatment of Spinal Stenosis of the Lumbar Spine. Pain Management, 2(5): 457-465, ISSN 1758-1869.
18. Chen, Hamilton, et al. (2012), mild® Procedure for Lumbar Decompression: A Review. Pain Practice, 2013; 13(2): 146-153 doi:10.1111/j.1533-2500.2012.00574.x
19. Udeh BL, et al. The 2-Year cost-effectiveness of 3 options to treat lumbar spinal stenosis patients. Pain Practice, 2014.
20. Wang JJ, et al. Decrease in health care resource utilization with MILD. Pain Medicine 2013; 14:657-661.

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Dear CMS,

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

As an investigator in the CMS-approved RCT comparing MILD to epidural steroid injections, I am stunned and disappointed by this decision.

The physician reimbursement and site fees paid for study participation were not enough to cover the time and expense. Despite the economics, I chose to participate because I believed I was doing the right thing for patients, my practice and for the broader health care system. I expected that MILD would be covered by Medicare if the agreed-upon study endpoints were achieved. This expectation inspired my participation in the study and justified the net expense to my practice.

The study protocol was developed with CMS input, and the final version was explicitly approved by CMS. When 12-month outcomes were assessed (the primary endpoint), MILD demonstrated superiority versus ESI – without question. Superiority was clearly defined in the study protocol, as were all other study objectives, all of which were achieved.

All hurdles set in place by CMS have been cleared. Yet, instead of unrestricted coverage, the proposed decision creates a new set of hurdles. It ignores the investment I have already made. It seems entirely unreasonable.

I strongly urge CMS to reconsider its proposed decision and provide for unrestricted coverage in the final decision. This is the only outcome consistent with the results produced by years of effort.

Richard Lingreen, MD

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My name is Jay S. Grider DO, PhD, MBA and I am a Professor of Anesthesiology and Medical Director of the Pain Services at UKHealthCare. I’m writing to express my disappointment and disagreement with CMS’ proposed ruling on MILD. As an author of one of the early studies on MILD (non-industry sponsored by the way) I am very familiar with the safety and efficacy of the procedure in clinical and investigational settings. Quite frankly, I’m having a difficult time reconciling the decision with the direction that CMS offered when deciding to put the MILD under the CED process initially. If the reason for CED was to allow CMS to gather comparative outcome data in order to make a coverage decision, and CMS approved and reimbursed the study, and the data was clinically and statistically superior versus the comparator then what is keeping CMS from making a favorable decision? Since the study was created in consultation with CMS to develop meaningful endpoints and since these endpoints were rigorously collected, evaluated and eventually, in a non-biased study, to be favorable for patients with spinal stenosis treated with MILD I am unclear as to the reasons behind the current decision to require a second less rigorous evaluation. The reasoning cannot be safety as this clearly established. To ignore your own process and subject the procedure to yet another study (of lower scientific value nonetheless) that will provide redundant data to what is currently available seems disingenuous and inconsistent with the concept of new technologies for CMS beneficiaries.

Having seen first-hand the impact that neurogenic claudication has on the quality of life for patients and also seeing the dramatic and positive improvements from the MILD procedure I ask that you reconsider your draft and afford coverage to this proven procedure to patients in need.

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September 13, 2016

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

As one of the Investigators for your approved ENCORE CED study, I am quite surprised and concerned by CMS’s response and proposed action plan for access to the mild® procedure.  I appreciate your proposal to “continue to cover mild® under CED for new patients with LSS enrolled and followed in a CMS-approved prospective cohort study” but I do not believe this is a reasonable plan for expanding coverage for this life changing procedure.

First off, we recently finalized the 1-year outcome data for the ENCORE.  We were eager participants in this study because we wanted to further develop the already substantial data on mild® and provide CMS with enough evidence to make a confident decision on providing coverage for this procedure.  The 1-year outcome data clearly met it endpoints and showed statistically significant superiority to the comparator.  The data on this study alone should provide ample information to make a qualified decision but when you couple it with the already existing evidence on the mild® procedure, you should feel totally justified in allowing coverage to all Medicare patients. 

Although we are satisfied with these results, participation in the CED study put a large burden on our patients and staff.  The proposed cohort study would only add to this burden.  When you factor in all the extra activities needed for a patient to take part in a cohort study (consent, multiple follow up appointments, randomization, inclusion/exclusion criteria, paperwork) and the extra staff hours needed to properly execute a cohort study (IRB approval, extra staff, data entry, follow up visits, training, data collection, paperwork) the reimbursement for this procedure does not remotely cover the cost.

Secondly, clinical studies can serve as a detriment to patients that would otherwise be interested to undergo the same procedure outside of a clinical study.  Oftentimes, patients are intimidated by enrolling in a study.  They may not fully understand its intent and also do not want to commit to the long term obligations.  Studies may also give the impression that the procedure is not effective and many patients may not want to take the chance of getting enrolled into the control arm.  Also, by having only a limited number of study sites, you are unjustly excluding some patients based on geographical as well as social/economic factors.

Finally, the data that you are proposing for this study is not as powerful as the data that was just collected for the already approved ENCORE CED study or for many of the other studies that have been published on the mild® procedure.  These studies have already provided statistical data on the most stringent outcome measurements and another study of lesser quality would not provide you with any meaningful information.

In conclusion, the Level 1 data that was collected in your ENCORE CED study, should provide you ample information to make a positive coverage decision for mild®.  An additional cohort study would not provide you with any additional information and would be costly and continue to prevent patients from receiving the treatment.  mild® is a proven safe and effective treatment for LSS and has shown superiority to other Medicare approved treatment options.

With all of this in mind, I am respectively asking CMS to develop a policy that would allow for immediate coverage of mild® for all qualified patients.

Sincerely,

Razmig Haladjian, MD

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Dear Ms. Syrek Jensen

As an interventional neuroradiologist based at the VA in Little Rock, Arkansas, I have personally witnessed the significant benefits of MILD for hundreds of our Veterans. Having performed over 300 MILD procedures, I am one of the most experienced users of the MILD procedure. These benefits have been consistently observed and reported in over 20 published articles and 12 clinical studies. Most recently, Benyamin and Staats published one-year follow-up for the ENCORE randomized controlled CED study which demonstrated the statistical superiority of MILD for all primary and secondary endpoints (1).

Thank you for this opportunity to voice my very serious concerns regarding your draft NCD proposing the requirement for an additional CED. I believe that this action would restrict patient access to MILD so severely that availability of the MILD devices in the market would be in serious jeopardy.

The administrative and cost requirements for a prospective cohort study would be prohibitive for most interventional pain practices. This study would require informed consent, IRB approvals, follow-ups, and data collection. All of this involves additional staff and a significant time commitment. With the low reimbursement amount for MILD of less than $3500, most interventional pain practices will not be able to justify participation. As a result, access to MILD will be severely restricted.

It is also important to acknowledge that MILD is low cost, and serves to reduce healthcare spending. Specifically, I reference the article published by Wang, et al. which compared health care resource utilization before and after the MILD procedure (2). These MILD cases were conducted within the Veteran’s Administration health care system. The authors report a nearly 45% reduction in time spent in specialty care, and an almost fourfold decrease in the number of interventional pain procedures performed on patients with lumbar spinal stenosis. Further, over half of the patients no longer required chronic pain management to treat their LSS symptoms. The authors conclude that MILD is a reliable method for treating LSS, and it also reduces the consumption of limited health care resources. This conclusion is supported by Udeh et al. that report cost savings with MILD versus both ESIs and surgery through two year follow-up (3).

The requirement for an additional prospective cohort study does not make sense for a number of reasons, but importantly it is less scientific and provides a lower level of evidence than the ENCORE RCT which was Level I. Further, the ENCORE CED was specifically-designed as a randomized controlled trial to provide the evidence needed for CMS to make a coverage decision. ENCORE was conducted per the protocol design, and the results demonstrated superiority of MILD. Multiple studies have also reported significant healthcare cost savings with MILD versus other treatment options for LSS. The costs associated with an additional CED study would be prohibitive and would restrict access. In closing, the request for further study under CED is unreasonable, and risks the loss of this important treatment option for our patients throughout the US, including the important Veteran community which I serve. I strongly urge you to cover MILD with no requirement for further CED. Thank you.

Muhammad Yousaf, MD

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Dear Ms. Jensen,

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

I am greatly disappointed in the draft decision. I believe CMS proposed additional prospective cohort study will not provide any new information. In addition this proposed cohort study would be costly to execute in practice because they require specialized resources. Most importantly clinical studies will require time to conduct and this will further delay access of this important therapy to the many patients that suffer from this condition.
I urge the agency to reconsider for full coverage. Thank you

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

I was an investigator in the MiDAS ENCORE CED Study and have been performing the mild procedure since 2011. To date, I have treated approximately 125 patients with the mild procedure. The outcomes for patients treated with mild in my practice have mirrored the clinical data available.^1-4 Patients report an improvement in mobility and pain, and their results are durable. The mild procedure is an invaluable addition to treatment options for LSS patients who deserve access to safe, effective procedures like mild. As most of my colleagues, I have been anxiously awaiting this reconsideration to be able to offer mild to my patients again and I am extremely disappointed with the suggested coverage policy for the following reasons:

• The draft policy and suggested next steps are illogical and inconsistent with the CED process as outlined by CMS. For example, Section VIII of the ‘Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development’ policy (https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27) states, “A CED cycle is considered completed when CMS completes a reconsideration of the CED coverage decision, and removes the requirement for study participation as a condition of coverage.” The draft policy is requiring study participation as a condition for coverage, which conflicts with the above statement. Since the CED cycle was completed and the reconsideration was opened, CMS should not mandate study participation as a condition of coverage. The existing data from the MiDAS ENCORE CED study achieved all endpoints and the data is sufficient to make a positive coverage decision.
• The suggested Prospective Cohort Study will limit patient access. Patients want to be treated by their physicians in a general practice setting and be offered proven, safe treatment options by their trusted provider. mild will as an appear ‘investigational’ procedure if only offered through a clinical trial setting, causing patient resistance to participation. The procedure has been well studied and the outcomes are proven and impressive. Patients deserve access in a normal routine of care - asking for multiple follow-up visits to collect low-quality data will not result in better patient care, use of resources or outcomes.
• A Prospective Cohort Study will produce less valuable data than what exists now. MiDAS ENCORE was a well-designed study that produced level 1 data.¹ The MiDAS ENCORE outcomes were statistically and clinically relevant, proving mild to be a superior treatment for LSS. The collection of additional lower quality data is not a best practice and will not help us as physicians make more informed decisions or treat our patients better. The Prospective Cohort Study is an unnecessary roadblock for patients and providers.
• The suggested coverage path is unprecedented and discouraging. No LSS therapy has been through this level of scrutiny. Requiring a prospective cohort study as a basis for coverage (including fusion, surgery, ESI, RF ablation) is unnecessary and illogical.

Please reverse this draft policy and provide positive coverage for the mild Procedure. The data exists to support this therapy and patients deserve access.

Sincerely,

Gavin D Chartier MD

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My is Stanley Golovac, I am a senior instructor and very experienced physician. I have personally performed over 285 MILD cases with an improvement rate of over 85 % I have personally participated in 3 of the clinical trials proving the efficacy of this unique procedure. I appreciate CMS opening PILD up for reconsideration. This is a well-established therapy and I have many patients that fit the criteria and would clearly benefit from this procedure. I have reviewed your posted draft policy and I am happy that you want to provide more patients the with the ability to have this treatment modality available to them. I agree with you that more patients should have MILD as a treatment option for them, but I strongly disagree with the means by which you intend to make it available.

Over the past 8 years, MILD has been extensively studied by the most respected and well known physicians and institutions in the country. The outcomes have been widely published and the results, whether at 6, 12 or 24 months have always been consistent. After reviewing the most recent 1-year data of the ENCORE study that you used to develop this proposed decision, I am quite surprised with your methodology for patient access. The ENCORE study is a robust, level 1 study that provides sufficient evidence for coverage of this procedure showing statistically significant improvement using well established measurement tools such as ODI, Zurich Claudication and VAS thus increasing mobility, decreasing pain and enhancing quality of life (see published results of ENCORE study).

As I read through your draft proposal, it seems that you are looking to recapture data that has already been established in the ENCORE study, which CMS approved as part of the CED. Also, I am perplexed by the fact that you approved the ENCORE study yet now say that measurements are not sufficient. How could they be sufficient at the time of study approval but now that they have been clearly met, they are insufficient? Did not the ENCORE meet all your clearly defined endpoints and show proven superiority to ESI?

In your draft, you also propose to continue and expand coverage by means of yet another CMS approved clinical research study. When is enough? In your approved ENCORE CED and in the other studies you reference in the draft, essentially all endpoints, inclusion/exclusion criteria and outcomes were identical. To perform yet another study using the same criteria and endpoints would only limit treatment, further delay approval, increase cost, and further burden the already exhausted healthcare system. All of this to further collect data that has already been established does not seem to be in the best interest of the CMS beneficiaries.
I urge you, for the benefit of CMS beneficiaries that have been suffering from LSS for years, to change the course of this draft and establish an open coverage policy for PILD. The safety and efficacy of PILD is already well established and proven. It is unfair to the patients to continue to study a procedure that has produced consistent outcome data time and time again. The most reasonable and ethical solution is to allow this treatment to be available to all patients that are qualified candidates.

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Dear Ms. Jensen,
I am writing on behalf of all my colleagues at Deaconess Comprehensive Pain Center. We are extremely disappointed in the proposed draft decision for the PILD procedure. I participated as an investigator in the MIDAS ENCORE Randomized study, which was approved by CMS with specific study endpoints designed to provide the necessary information needed to make a coverage decision. Study sample size was powered to test for superiority. the data generated in this study met statistical and clinical significance. Therefore it is surprising that the agency is requesting an additional study. Furthermore the randomized study should be evaluated based on established study endpoints. To consider other data such as the MIDAS ENCORE 2 year data would not be reasonable as it was not a predesignated endpoint and therefore not power for the study.

The proposed prospective cohort study will not generate any new information as it is requiring the same inclusion/exclusion criteria. To conduct another study will be costly and time consuming. We urge the agency to reconsider and grant coverage to the PILD procedure.

Your correct decisions for those suffering from Lumbar Spinal Stenosis will be most appreciated

Joseph F. Waling M.D.
4099 Gateway Blvd.
Newburgh In. 47630

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Thank you for the opportunity to provide a comment on the National Coverage Analysis for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433R). I began performing PILD, specifically the MILD Procedure, in 2011 and have treated over 900 patients. I strongly disagree with the proposed decision memo and urge CMS to revise the policy to provide unrestricted patient access to the MILD Procedure. The level of scrutiny the MILD procedure has been under is unprecedented and unjustified. The procedure has been well studied and the compendium of existing published clinical data clearly proves it is safe and effective. The recent CED study, MiDAS ENCORE, was designed to provide clarity and enable CMS to make a coverage decision. The study was completed, the data met all required endpoints, and therefore coverage should be granted. The concept of requiring the collection of additional, lower quality data is not reasonable or necessary.

There is a need and a patient demand for the MILD procedure; limiting MILD access to a clinical trial setting will limit the number of providers and therefore limit patient access. MILD is a proven therapy that patients should have access to. CMS has the required data to make a positive coverage decision.

I urge CMS to provide national coverage for the MILD Procedure.

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As a principal investigator in the MiDAS ENCORE randomized controlled CED study, I was astonished by CMS’s proposed decision to require yet another CED study. Over the last 2 years, my colleagues and I have made a substantial commitment of time and resources for the purpose of completing the CMS-approved ENCORE Level 1 CED study. The ENCORE study was completed successfully, and the statistical superiority of MILD was demonstrated for all primary and secondary endpoints as reported by Benyamin and Staats*. We all believed that successful completion of this CMS-approved CED study would provide the necessary evidence to support a coverage decision. Clearly this must be true, given that the MiDAS ENCORE protocol was reviewed and approved by CMS for this purpose!

Imposing a new study requirement at this stage calls into question both the transparency and logic of the CED process. How does conducting a lower level study with the same selection criteria and outcome measures as the Level 1 randomized controlled trial make sense? The proposed prospective cohort study will not supply any new information, and will provide lower quality data. Further, the MILD procedure is often conducted in the ASC setting by interventional pain physicians in private practice. We don’t have the administrative staff available on an ongoing basis to collect data, conduct follow-up, and administer patient reported outcome measures. In addition, the proposed prospective cohort study would require IRB approval and study patient informed consent. The costs for such a study are high, and with low reimbursement of less than $3500, it is not possible to conduct this study.

CMS must acknowledge that the criteria for coverage as defined in 2014 has been successfully achieved. The proper decision for CMS is to provide coverage of the MILD procedure with no restricted access. Thank you for considering this comment.

Richard Paicius, MD

*Benyamin RM, Staats PS, for the MiDAS ENCORE Investigators. MILD is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE randomized controlled trial. Pain Physician 2016; 19:229-242.

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