Lumbar Artificial Disc Replacement

To Whom It May Concern:

I have read the proposed CMS coverage decision memorandum proposing a national non-coverage determination for lumbar artificial disc replacement dated February 15, 2006. I respectfully yet strongly object to such a determination for several reasons which I will explain below.

While CMS is particularly interested in public comments that include evidence that CMS did not review, they are quick to dismiss any unpublished evidence as well as results of individual practitioners as less rigorous and therefore less useful for making a coverage determination. Nonetheless, I will provide this information purely for purposes of establishing my level of experience with the Charité artificial disc. On 16 February 2006 I separated from the US Navy, where I served as the Director of Spine Surgery at Naval Medical Center, Portsmouth, Virginia from August 1998 through February 2006. During the past year, I had the opportunity to implant 35 Charité disc prostheses on active duty service members, retirees and dependents. During that period, Naval Medical Center ranked among the top 25 volume producers nationally using this technology. I am not going to provide specific patient outcomes, as CMS has made it clear they are not interested in that kind of evidence, but I will tell you that I returned active duty sailors and marines to full duty with 0/10 VAS scores at three months post-op. I have never been able to do that with any fusion patient, and I perform all of my fusions using minimally invasive surgical techniques.

There are several major problems I see with the proposed national non-coverage determination. CMS appears to have concern over three main issues: patient selection, adverse events and long-term outcomes. Not surprisingly, these are the issues that surgeons are concerned about with every surgical procedure that they perform.

With regard to the patient selection criteria for the Charité artificial disc, I believe the indications are very clear and are so stated in the FDA study inclusion criteria. Some of the early case series (less rigorous evidence), reported on in the CMS Proposed Decision Memo, were published much earlier than the Charité FDA study and hence the patient selection criteria had not been firmly established at that time. These early case series were used to help establish more the rigid patient selection criteria used for the FDA study. Nothing takes the place of experience in helping to more firmly establish the correct patient selection criteria in surgery. While most of the patients that I have performed this procedure on have done incredibly well; a few have not done quite as well as the others. Looking back, one may identify a common feature of patients that do well versus those who do less well. This kind of experience and improvement in patient care can only come if the surgeon is allowed to perform the procedure in the first place. As a final note on patient selection, it is the single most important determinant of the patient’s long-term outcome. The right operation performed on the wrong patient will yield a poor outcome. Surgeons pay particularly close attention to patient selection and believe that we are uniquely qualified by our training and experience to determine who is and who is not a good candidate for a particular surgical procedure. We are ultimately responsible for the patient’s care. We will be the ones that they will cry to if the surgery fails. We do not expect it to appear to be straight forward to those who are not surgeons and who have not been in the position to have to make the decision.

The Proposed Decision Memo notes adverse events related to the anterior spinal approach. While there are potential risks associated with the anterior approach to the spine, it must be remembered that this is exactly the same approach that is used for anterior lumber interbody fusion (ALIF) which was the control procedure used for the Charité FDA study. ALIF is the fusion procedure of choice for a large number of spine surgeons, so limiting a patient’s access to disc replacement is not going to protect them from potential adverse events, as they may have an ALIF instead. Additionally, one must remember that the posterior approach to the lumbar spine has its own unique list of potential adverse events. Review of the Medical Device Report data from 26 October 2004 through 15 October 2005 reveals an adverse event rate of only 2.1% compared to 7.2% reported from the FDA study. This adverse event data compares very favorably to complication rates reported for spinal fusions performed through a variety of approaches. Any surgery has associated risks including death. Every patient is given full informed consent for any surgical procedure, no matter how big or small the procedure may be. Presumably the patient is going to weigh all of the risks and benefits prior to making a decision to have any surgery. Surgery for the treatment for back pain is generally elective, as back pain is generally not a life-threatening condition, although it may make the patient miserable. I believe that most surgeons are very careful to ensure that the patient fully recognizes the potential risks of elective procedures prior to consent. This again is an area that the by means of his training and experience, the surgeon is uniquely positioned to counsel the patient on and allow the patient to make an informed decision. Any interference by the government into this decision-making process, not only interferes with the doctor-patient relationship, but is paternalistic. Who, but the patient has the right to decide whether the potential adverse events associated with a particular surgery outweigh the benefits?

There is a lack of long-term prospective randomized controlled studies available in the medical literature regarding the Charité artificial disc prosthesis. van Ooij reported on 27 patients with an unsatisfactory outcome from an original cohort of 500 patients. They reported to him at a mean of 53 months post-operatively. That represents only 5.4% unsatisfactory results at 4 ½ years follow-up. Of the 26 patients presenting with late complications, 12 had degenerative disc disease already apparent at another level prior to the artificial disc replacement. In these 12 patients, provocative discography determined those other affected levels not to be painful at the time of the index procedure. In an additional seven patients, degenerative disc disease developed adjacent to the disc prosthesis at levels thought to be within normal limits at the time of the index procedure. One must remember that the degenerative process of the human spine is an ongoing process. The implantation of an artificial disc at one level of the spine will not stop or reverse the degenerative disease process that is taking place at the other disc levels any more than implantation of a total knee will stop or reverse the degenerative process taking place in the contralateral knee. Certainly if those same 19 patients had fusions instead of artificial disc replacements the fate of those adjacent disc levels would be no better at 53 months post-op and in all likelihood would be much worse. In 10 of the 18 cases of subsidence described by van Ooij the size of the prosthesis was “definitely too small.” Facet joint arthrosis at the operative or neighboring levels was identified in 11 patients. Significant facet joint arthrosis is considered a contraindication for artificial disc replacement and surgeons performing this procedure are aware of that. Anterior migration of the prosthesis is generally due to technical errors, such as incomplete discectomy or incorrect sizing of the prosthesis. Problems with breakdown of the polyethylene have been traced to gamma sterilization in air and have been resolved. The van Ooij study provided valuable information for surgeons performing this new surgical procedure. As the technology continues to develop more long-term data will become available. Sufficient long-term data on patients over the age of 65 will only become available however, if these patients have access to this new and promising technology.

While I have not performed this procedure on a patient over the age of 65, the decision should be left to the patient and his physician. CMS has no business engaging in the practice of medicine, which is essentially what they are doing by proposing a national non-coverage determination. This proposed decision limits access to an FDA-Approved medical technology by the largest growing segment of the population. There are also approximately 6,079,981 people in the United States under the age of 65, who receive Social Security cash payments due to disability who will also be affected by this decision. CMS claims that there is insufficient evidence to conclude that the Charité lumbar artificial disc is reasonable and necessary. It is my observation that CMS applies inconsistent handling of the medical literature and I offer the following example:

Effective January 2006, CMS increased reimbursement for Intradiscal Electrothermal Annuloplasty (IDET), a minimally invasive outpatient procedure that treats discs in patients with chronic discogenic lower back pain. CMS will reimburse $1424.50 for the procedure in 2006, in place of the 2005 payment level of $622.43. That represents an increase of 129%. IDET has been in widespread use for several years, but until publication of the first randomized, placebo-controlled trial by Pauza et al in The Spine Journal in early 2004 there was no prospective data in the medical literature. Up until that time, CMS coverage of the IDET procedure was based on several case series of a few hundred patients, including those of the inventors of the procedure. The most important of these case series include: Karasek & Bogduk, Spine 2000, Saal & Saal, Spine 2000, and Saal & Saal, Spine 2002. From these three case series a total of 156 patients received IDET after failing a trial of 3 to 6 months of conservative treatment. It is interesting to note that the mean age of the patients receiving IDET was 40 and the age range was 20 to 59. There were no patients 65 or older enrolled in any of the case series. Also of interest is the fact that every patient in the intervention group as well as the control group in these studies underwent provocative lumbar discography as an indication for inclusion in the study.

Now granted, IDET is a significantly less invasive procedure than artificial disc replacement, but should medical evidence not be handled equitably when making coverage decisions? CMS has criticized the use of provocative lumbar discography as a diagnostic aid in patient selection for lumbar artificial disc replacement, yet it is applied in every case of IDET. The fact that there is no data available on long-term or short-term outcome of IDET in patients over the age of 65 did not result in CMS proposing a national non-coverage determination for it. In fact, as I have stated above, CMS saw fit to increase the reimbursement for IDET in 2006, even in the face of evidence that it is ineffective. The randomized, placebo-controlled, prospective trial conducted by Pauza, et al studied 64 patients, average age 42 years (32-52 years). 37 patients were randomized to the IDET group and 27 to the sham group. The results showed modest overall benefit, although many patients did not seem to improve at all. A retrospective study of 60 consecutive patients, average age 40 years (25-64 years), published in Spine (Davis, Delamarter, et al 2004) reported nearly all patients (97%) continued to have back pain, with 58% reporting the same amount or more pain at follow-up than pre-IDET. Finally, a prospective, randomized, double-blind, placebo-controlled trial of IDET (Freeman, Fraser, et al 2005) published in Spine reported on a total of 57 patients. There were 38 patients in the treatment arm, mean age 37.5 years (20-54.5 years). No subject in either arm showed clinically significant improvements at 6 months following treatment. They concluded that IDET is no more effective than placebo for the treatment of chronic discogenic low back pain. In an editorial that followed, Timothy S. Carey, MD, MPH commented: “Given the additional results reported in this issue, caution should be advised to patients and providers considering IDET treatment.”

I recognize that the purpose of this comment period is not to discuss IDET. However, my point is to illustrate that CMS appears to ignore very rigorous medical and scientific data in their decision-making processes. I could understand CMS proposing a national non-coverage determination for a procedure like IDET, based on the data that I presented above. However, this type of rigid data is not currently available for the Charité lumbar artificial disc. The only way that surgeons, patients, and healthcare agencies in the United States are ever going to have availability of good quality scientific medical research regarding this device is if we generate it in the United States. It is not the responsibility of CMS to determine if the Charité lumbar artificial disc is a safe and effective medical device. This is the responsibility of the Food and Drug Administration and the FDA has already made its decision by approving the device.

In consideration of this apparent lack of consistency in the handling of medical evidence by CMS, particularly with regard to procedures for the treatment of degenerative disc diseases in persons 65 years and older, I would request that CMS reconsider its position on the Charité lumbar artificial disc. Evidence generated in the United States to date suggests that motion preservation in the treatment of degenerative disease of the lumbar spine is the correct direction we should be moving in. A national non-coverage determination will not only interfere with the doctor-patient relationship, but it sets a dangerous precedent if the federal government rather than physicians determine who is eligible for a particular treatment based on their age. Where will it end? It is a dangerous "Slippery Slope."

Additionally, CMS is fully aware of the impact that its policy has on the decision-making of the insurance industry as a whole. As such, it is my strong conviction that a national non-coverage determination has significant implications for restraint of trade. Any blanket decision that is going to essentially affect the entire healthcare market place in such a way as to restrict access to an otherwise approved medical device is nothing less than abuse of state power.

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I am an Orthopaedic Spine Fellowship trained surgeon with a medical practice limited to spine surgery. I have implanted a total of 15 patients with Charite disc implants (21 total implants). The majority of the patients are happy that they have had the operation. The operation has allowed injured police officers to return to work. One patient implanted early in the series required reoperation for implant subluxation, she underwent a revision to a solid arthrodesis and has subsequently returned to work as a realestate agent. Overall, patient satisfaction seems to equal or exceed that of similar patients treated with standard fusion technology. Regarding hospitalization, the artificial disc surgery requires shorter operative time, less blood loss, shortened hospitalization, and earlier return to work than comparable patients treated with standard fusion. I will be happy to provide additional information if so desired. I am not a consultant for Johnson & Johnson. I do not own J&J stock. I do not recieve royalties or compensation for the use of these products.

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I would like to comment opposing CMS' decision for non-coverage for the FDA approved total disc replacement procedure for the lumbar spine. I have implanted approximately 30 of the Charite disks in appropriate patients since FDA approval. We have tracked the results of those patients very closely, and the results mirror those seen in the now published IDE study which resulted in FDA approval. Specifically, following the total disc patients with a VAS pain scale, as well as an Oswestry Disability Index, I have seen the same dramatic improvement that was seen in the IDE study in my patients in the early months after surgery. Our longest follow-up is just over one year, with over 20 in the six month to one year follow-up (we use these follow-up scales at 6 weeks post op, at 3 months post op, at 6 months post op, at one year post op, and at 2 years post op). The dramatic improvement comes much quicker with these patients than had been my experience with fusion patients. Also, I don't seem to have the common post op complications that come with fusion, such as sacro-iliac symptomatology, symptomatic screws and rods in the back, pseudarthrosis (failed fusion), and the long slow painful recovery that even successful fusion patients have to endure.

Just to give you a snapshot of my practice, I am an orthopedic surgeion in private practice (now for 15 years). My practice is limited to spine. Although placing a total disc prosthesis is technically demanding, it can be accomplished reliably using the Centerline instruments designed by DePuy. I do not practice in an academic institution, and yet have been very satisfied at my ability to place the prosthesis accurately within the center of the disk space.

The device seems safe, and is definitely effective at improving symptomatology and returning function to patients struggling with sypmtomatic degenterative disc disease in the lumbar spine.

With regard to CMS' decision, although osteopenia and/or osteoporosis is a contraindication, there are many patients over 65 who have been historically very active, have excellent bone quality, and are struggling with severe debilitating pain from degenerative disc disease. Given that the greatest growth in our age population is those people over 100, we have to change our thinking about how to treat the active 65 to 70+ year old patients who are limited by unmanageable pain due to a single degenerated disc disease in the lumbar spine and have excellent bone quality. These patients could be ideal candidates for total disc replacement. In addition, there are a significant number of younger patients who are disabled for reasons unrelated to their spine and thus have Medicare as their insurance carrier. Invariably, some of these patients will develop severely symptomatic degenerative disc disease that further limits their life and function. Provided they do not have contraindications, many of these patients could similarly be helped by total disc replacement surgery.

With regard to longer term studies, I was just at a medical meeting a couple of weeks ago where Mathew Scott Young, MD (from Australia where he has been performing the operation for about 15 years) presented 10 year follow up data on Charite total disc replacement patients. He was able to get follow-up on 85% of his patients, and showed that the early favorable results seen do not seem to deteriorate with time.

Given the above, I implore you will reverse your non-coverage decision regarding lumbar total disc replacement. In the appropriate patients that have Medicare as their insurance carrier, this would allow these deserving patients to have access to this new promising technology, which has been proven (by the most rigorous of studies) to be a safe and effective treatment.

Thank you for considering the above comments.
P Schwaegler

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The following comments are a duplicate of comments previously submitted by email.

On behalf of our client, Stryker Corporation (“Stryker”), Hogan & Hartson, L.L.P. appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (“CMS”) draft coverage decision memorandum for lumbar artificial disc replacement (CAG-00292N) (hereinafter “Decision Memorandum”).¹ Stryker is developing the FlexiCore® Lumbar Intervertebral Disc Replacement (“FlexiCore”), which is currently being investigated in a U.S. IDE study. The FlexiCore’s all metal design may have potential advantages over fusion devices and over other artificial disc bearing designs.

We are greatly concerned by CMS’ proposed decision to issue a national non-coverage determination for the Charité lumbar artificial disc “Charité”), and we urge the agency not to finalize this proposal. As we explain in detail below, we believe CMS’ interpretation of the clinical evidence does not give adequate weight to the potential benefits of the Charité. Contrary to CMS’ conclusions, Stryker believes there is ample evidence to support a finding that lumbar artificial discs are a reasonable and necessary treatment for Degenerative Disc Disease (“DDD”). Given the known limitations of the alternative treatment option, spinal fusion, availability of other options such as artificial discs is necessary to provide physicians with the flexibility to choose the optimal surgical intervention for each patient.

Furthermore, CMS reached this proposed decision using an undefined standard for evaluating whether an item or service is reasonable and necessary. The “adequate evidence of net health benefit” standard used in this draft decision has never been defined in regulation or a guidance document and thus is an unfair basis for any decision to deny coverage of a medical technology. Making a national non-coverage determination based on this vague standard would unfairly deny beneficiaries access to an appropriate treatment option and would risk stifling further innovation.

Instead, we recommend that the agency refrain from issuing a decision at this time and continue to allow local contractors to decide whether to cover this technology. If CMS nonetheless decides to issue a non-coverage decision, we urge the agency to limit it to beneficiaries over the age of 65 and to the Charité device. The former limitation is consistent with CMS’ focus in the Decision Memorandum on patients over 65. The latter limitation is appropriate in light of the substantial differences in both device design and study design of other artificial discs that are under investigation, several of which are expected to be approved by FDA in the next one to two years. To apply the decision more broadly could deny appropriate patients access to an important treatment option.

I. BACK PAIN AND ARTIFICIAL DISCS

As CMS notes in its proposed Decision Memorandum, as many as 80% of U.S. adults suffer from low back pain at some point during their life. For a significant number of U.S. patients, the cause of low back pain is DDD.² A natural consequence of the aging process, studies indicate that by age 50, up to 90% of subjects show some evidence of disc degeneration.³ Although the majority of these subjects may not demonstrate symptoms of DDD, progressive deterioration of intervertebral discs can cause significant pain and lead to quality of life limitations. Low back pain associated with DDD is one of the leading causes of lost work time. Although most patients with DDD respond well to nonsurgical treatments, a subgroup with chronic, disabling pain do not respond to conservative therapies.⁴

For many years, the only option for patients who did not respond to conservative treatment was fusion. Although fusion is successful in many patients, it is not the right treatment for every patient. Fusion is associated with significant rates of pseudoarthrosis. In addition, fusion procedures typically involve the use of bone graft, which itself is associated with significant adverse effects. Iliac crest autograft, the traditional method of bone-grafting, is associated, in a significant percentage of patients, with graft site adverse events, including pain and other complications such as hematoma and fracture.⁵ Allograft may be used to avoid donor site complications, but may be associated with a small but significant risk of transmissible disease and rejection reactions.⁶ Finally, there is significant concern that spinal fusion not only effectively eliminates the motion of the vertebrae at the treated level, but also results in increased stress on adjacent spinal segments, potentially leading to adjacent segment degeneration.⁷

Because of these limitations, which have been recognized for decades in the medical literature, efforts began in the 1960s to identify a suitable replacement for the native disc. After many years, the resulting advances in technology are now becoming available to U.S. patients. The Food and Drug Administration “FDA”) approved the Charité in 2004. In addition, the Agency issued an approvable letter for Synthes’ ProDisc-L Total Disc Replacement on January 5, 2006. Furthermore, several new artificial discs are currently at various stages of development. Although none has yet been approved by the FDA, they represent additional potential future options for patients suffering from DDD. Differing in physical characteristics from the Charité, these devices bring the possibility of even more promising results for patients.

Artificial discs seek to relieve pain resulting from DDD while preserving motion, potentially avoiding adjacent segment degeneration, reconstituting disc height and spinal alignment, decreasing surgical morbidity compared with fusion, avoiding complications from instrumentation or postoperative immobilization, and allowing an early return to function.⁸ If CMS chooses to move forward with the proposed non-coverage decision, patients in need of a surgical approach to treatment of low back pain will be left only with the option of lumbar spinal fusion, and physicians will effectively be constrained from choosing the treatment that they believe is most appropriate for the individual patient.

II. CMS SHOULD ISSUE NO NCD NOW AND CONTINUE TO ALLOW LOCAL MEDICARE CONTRACTORS TO MAKE COVERAGE DECISIONS

The DePuy Spine Charité artificial disc has been in clinical use for more than 20 years. The Charité disc has been shown in clinical studies, both domestically and abroad, to be safe and effective in treating DDD and alleviating associated low back pain. Results of the U.S. IDE clinical study, discussed below, demonstrate the safety and effectiveness of the Charité for clinical use in the treatment of DDD, as well as a number of benefits of treatment as compared to traditional fusion treatment. Specifically, the Charité was shown to provide advantages in function, pain, speed of pain relief, patient satisfaction, lower incidence of post-surgery narcotic use, range of motion, and maintenance of disc height, while simultaneously exhibiting similar rates of complications to fusion surgery. Accordingly, we strongly believe that the Charité offers both a reasonable and necessary treatment alternative to traditional spinal fusion.

CMS, in its proposed Decision Memorandum, uses the term “net health benefit” as a proxy for “reasonable and necessary.” It would be unfair and contrary to Congressional intent to deny coverage on the grounds that there is “insufficient evidence for a net health benefit” when CMS has not promulgated a clear definition of that standard, however. As CMS acknowledges in the draft Decision Memorandum, the statute requires that Medicare exclude from coverage any item and service that is “not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”⁹ The term “reasonable and necessary” has never been defined by statute or regulation. After CMS decided not to promulgate regulations defining the criteria for making coverage determinations,¹⁰ Congress instructed CMS to “make available to the public the factors considered in making national coverage determinations “NCD”) of whether an item or service is reasonable and necessary.” 11/ CMS has not yet issued a guidance document explaining the evidence required to make a positive coverage determination. Instead, CMS has used various forms of a “net health benefit” or “net health outcome” standard in draft guidance documents,¹² several NCDs,¹³ and Medicare Coverage Advisory Committee reviews¹⁴ without developing a clear and consistent definition of this standard or the type of evidence that is required to meet it. Until CMS has issued a final guidance document explaining this standard, CMS’ coverage determination process will remain unpredictable and opaque, and any non-coverage decision based on a failure to meet this standard would be fundamentally unfair.

Additionally, issuing a national non-coverage decision using this standard would impede beneficiary access to important and appropriate treatment options. Under the proposed decision, beneficiaries would be denied the option of using the Charité disc or any other lumbar artificial discs, regardless of whether their condition meets the device’s labeled indication. Beneficiaries also could be denied future treatment options if CMS’ unclear and unpredictable standards for making coverage determinations discourage investment in new medical technologies.

At the same time, although a precise definition of “net health benefit” has not been articulated by statute or in regulations, CMS appears to interpret this criterion to require balancing the risks and benefits of a new device.¹⁵ FDA similarly applies risk/benefit balancing in determining whether a new product has sufficient “clinical utility” to merit approval. Where FDA has concluded, based on its scientific expertise and in consultation with an advisory panel of medical experts, that a new medical technology has sufficient clinical utility to support premarket approval, based on weighing of risks and benefits, CMS should give this determination substantial weight in assessing “net health benefit.” Not only has the FDA found that the Charité demonstrates clinical utility, but there is also an extensive body of evidence to show that the device does provide a net health benefit. In situations where CMS differs from FDA’s conclusions with respect to the risk/benefit balance presented by the device, this conclusion should be based on comprehensive review, including consultation with medical experts of equivalent specialized expertise to those who serve on the reviewing FDA advisory committee.

It should be noted that although the Decision Memorandum does not expressly state that superiority to the control must be established for a new device to be found “reasonable and necessary,” the Memorandum does state: “Importantly, the major premise of spine segmental motion preservation is that adjacent level disease is increased by fusion surgery, and therefore that motion preservation will prevent this. However, there is no good evidence yet to support this premise, and there is some indication motion preservation with the Charité disc may not have an improved net health benefit.” (Decision Memorandum, p. 12). We believe that, to the extent this comment suggests that superiority to the control must be established to demonstrate a new device is “reasonable and necessary,” this is inappropriate for a medical device such as a lumbar artificial disc. Rather, particularly in cases such as this where the existing standard of care, fusion, does not yield optimal outcomes in all cases, it is useful and necessary to allow physicians flexibility to choose alternative surgical interventions. As indicated in the Decision Memorandum, the success rate in the control group, the BAK cage, was only 46%. Although CMS suggests that this control may no longer be considered optimal, even more recently approved fusion devices, such as Medtronic’s InFuse®, demonstrated only a 57% success rate in a similarly designed clinical trial.¹⁶ Thus, this is not a case in which the existing standard of care, fusion, provides an optimal result in all cases. Factors that may decrease the likelihood of bony fusion and, therefore, make fusion a less optimal intervention for some patients include smoking, diabetes, and chronic use of medications such as steroids that suppress bone formation.

For surgical implants, many investigations to support FDA approval are designed to demonstrate non-inferiority, not superiority. This differs from drugs, for which many studies are placebo- controlled, and thus designed to demonstrate superiority. Non-inferiority is an accepted statistical design for a clinical trial of an implant because the study compares the investigational device to the established standard of care, that is, safe and effective treatment for the condition in question. In addition, in many cases, no one implant or surgical intervention will prove optimal for all patients. Thus, it is desirable to have a range of surgical options available if they are of comparable safety and efficacy. For these reasons, although the results of the Charité study do demonstrate advantages over the control, as discussed below, demonstrating non-inferiority versus an active control treatment should be sufficient to establish that the device is “reasonable and necessary.”

Although we do not believe it is appropriate for CMS to apply an undefined “sufficient evidence of net health benefit” standard, we believe Charité would meet such a standard based on balancing of risks and benefits, regardless of how it is specifically defined. It should be noted that some private insurers have weighed the evidence and determined that treatment with the Charité should be covered. For example, Aetna issued an affirmative coverage notice of the Charité device stating that it was “medically necessary for spinal arthroplasty” for certain patients with DDD.¹⁷ Nevertheless, we understand that CMS does not believe the data are sufficient to warrant a positive coverage decision. Therefore, we recommend that CMS issue no national decision at this time and continue to allow local contractors to make coverage decisions for this technology. This would protect beneficiaries’ access to the Charité device or other lumbar artificial disc replacements when their physicians determine that it would be an appropriate treatment. Leaving coverage decisions to the contractors also would help to ensure that Medicare coverage continues to adjust with changes in the standard of care, rather than freezing access to new technology until CMS reconsiders this NCD. Moreover, it would encourage continued innovation by reassuring manufacturers that Medicare beneficiaries would be able to obtain coverage of their new technologies through the local coverage process until sufficient evidence is available to support a positive NCD. We believe that the evidence summarized below convincingly demonstrates that a national non-coverage decision would not be appropriate.

A. The Charité Data Demonstrate that it is Reasonable and Necessary for Some Patients with DDD

The Charité IDE study was a prospective, randomized, multicenter investigation comparing lumbar total disc replacement, using the Charité, to anterior lumbar interbody fusion in 304 patients for the treatment of single-level DDD from L4 to S1 that was unresponsive to six months of prior conservative management. Although CMS questions the choice of the BAK Cage as the control for this study, the BAK Cage was chosen because this was the only type of fusion device that was FDA approved for anterior surgical implantation in treatment of DDD at the time the study began.¹⁸ It should be noted that although other fusion procedures were available, the selection of a control using an anterior surgical approach was desirable because it permitted direct comparison of surgical risks to the Charité, which is also implanted using an anterior procedure.¹⁹ The study was designed to demonstrate noninferiority, with the statistical analysis of noninferiority based on a delta of 15% and the sample size determined based on an expected 70% success rate. The primary endpoint was individual patient success, defined as a patient meeting four criteria at 24 months: (1) greater than 25% improvement on the Oswestry Disability Index (“ODI”) compared to baseline; (2) no device failure requiring revision, reoperation, or removal; and no pseudoarthrosis in the control group; (3) absence of major complication, defined as vessel injury, neurologic damage, or nerve root injury; and (4) maintenance or improvement in neurologic status at 24 months, with no permanent neurologic deficits compared to baseline. Study results demonstrated overall success rates for the Charité and fusion groups of 57% and 47%, respectively, for the intent-to-treat population (p < 0.0001).²⁰ It should also be noted that covariate statistical analysis of the Charité data indicated that across the broad age range included in the study, age was not a significant covariate. The study, and other studies which have been conducted, demonstrate that the Charité is a device that is reasonable and necessary for certain patients.

1. Improvement In Function and Relief of Pain

Published study results have shown that the Charité provides patients with an improvement in both function and pain. Generally, studies of spinal implants utilize the Oswestry Disability Index (“ODI”) to measure the extent to which a person’s function is restricted by pain and the visual analogue scale (“VAS”) to measure pain intensity. In 2005, Blumenthal, et al. published results from the Charité IDE study.²¹ Results showed that both the Charité and control groups demonstrated significant improvement in the ODI and VAS scores compared to preoperative scores at all follow-up time points. Moreover, the investigational group had a statistically greater improvement in ODI and VAS scores than the control group at 3-, 6- and 12-month follow-up, and numerically greater improvement at 24-month follow-up, although this difference did not reach statistical significance. Thus, at all time points, greater improvement in ODI scores was demonstrated in the Charité group compared to the fusion group.²²

Additionally, Regan reported a single-site experience with the Charité in 100 consecutive patients with a minimum of 6 months follow-up, which similarly showed an improvement in both ODI and VAS scores.²³ The first 13 patients were part of the IDE study, and the following 88 patients were part of the continued access study. The mean preoperative VAS of 73.2 improved to 39.2 at 6 weeks, and this improvement was maintained at 3, 6, 12, and 24 months. The mean preoperative ODI score of 53.4 improved to 37.6 at 6 weeks, and this improvement was sustained at 3, 6, 12, and 24 months. The improvement in both pain and function reported in the Blumenthal and Regan publications demonstrates a clear benefit to patients.

2. Faster Relief of Pain Symptoms

Available data show that Charité patients report greater pain relief at earlier follow-up periods than do fusion patients. In the Charité IDE study, the Charité group demonstrated significantly greater improvement than the fusion group in VAS pain and ODI scores from 6 weeks to 1 year follow-up.²⁴ Commenting on this outcome, Dr. Regan noted that the Charité device allows for faster relief of symptoms as compared to fusion. Commenting during the FDA Advisory Panel meeting on the Charité, Dr. Blumenthal observed that the Charité Artificial Disc provided advantages over anterior lumbar interbody fusion in early clinical improvement, function, pain and quality of life, shorter mean hospitalization, higher patient satisfaction, and maintenance of range of motion through 24 months.²⁵

CMS attempts to discount these results, stating that at 24 months the Charité and fusion groups were equivalent with respect to VAS and ODI scores (Decision Memorandum, p. 9). However, this eventual equivalence does not diminish the importance of the earlier positive results achieved with the Charité. The faster relief of symptoms with the Charité supports the conclusion that it is reasonable and necessary as an option for treating DDD.

3. Greater Patient Satisfaction

Although CMS discounts satisfaction self-reporting as subjective and responsive to the placebo effect, the value of patient satisfaction should not be disregarded. The results of the Charité IDE study showed that at 12 months patients in the investigational group had a higher rate of satisfaction (71.3%) than those in the control group (59%). ²⁶ At 24 months, patients in the investigational group continued to demonstrate a significantly higher rate of satisfaction (73.7%) than did the control patients (53.1%). At the end of two years, 13% of the fusion patients were very dissatisfied with the procedure, compared to only 2% of the disc replacement patients.²⁷

Patient self-reporting is in fact a crucial means of determining improvement, as relief of pain is the primary objective of DDD treatment. Although potentially subjective in nature, patient satisfaction cannot be overlooked as an important benefit.

4. Lower Incidence of Narcotic Pain Medication Usage

Charité patients have also demonstrated a lower incidence of narcotic pain medication usage postoperatively as compared to fusion patients. According to Blumenthal, et al., a higher proportion of fusion patients (85.9%) in the IDE study reported use of narcotics to control pain during follow-up, as compared to Charité patients (72.2%). Among patients demonstrating clinical success, there was a significantly lower rate of narcotic use for pain at 24 months in the Charité group (64%) than in the fusion group (80.4%).²⁸ At 24 months, narcotic use in the fusion group remained above 80%.

Particularly given the potential complications and side effects that can result from the extended use of narcotic medication, Charité patients clearly benefit from the lower probability of requiring long-term medication usage as compared to fusion patients. Thus, this finding clearly contributes to the conclusion that the Charité disc is reasonable and necessary for certain patients.

5. Range of Motion

According to McAfee et al., radiographic outcomes showed that patients in the investigational group had a 13.6% mean increase in flexion/extension ROM at 24 months compared to baseline, while the control group demonstrated a mean decrease of 82.5%.²⁹ Mean ROM as measured on lateral flexion/extension films was equivalent between the two groups before surgery.

In 2005, SariAli, et al. reported on a study of motion in axial rotation at the L4-L5 level in 17 patients who had been implanted with the Charité disc, as compared to 6 healthy volunteers, with an average follow-up period of 12.4 years.³⁰ Five of these patients had one- level implantation at L4-L5, while 12 patients had two-level implantation at L4-L5 and L5-S1. Analysis was performed using dynamic radiographs. Eleven (65%) patients had normal mobility in torsion that was identical to that of the healthy controls, as well as that reported in the literature. Notably, all five of the patients who had only one-level implantation of the Charité disc experienced normal mobility in torsion. Among the patients who experienced normal mobility, mechanical coupling was also found to be identical to that of the volunteers. The investigators concluded that implantation of the Charité device at one level achieves axial rotation mobility equivalent to that of healthy controls and equivalent to that reported in the literature for normal functioning. The ability to regain motion at the operative level after surgery is a unique benefit of artificial disc replacement.

6. Disc Space Height and Subsidence

According to McAfee, et al., radiographic data showed that the Charité device was significantly more effective than fusion in restoring the height of the collapsed disc space.³¹ In addition, significantly less subsidence was identified in the investigational group as compared to the control group at all postoperative follow-up periods. Accordingly, investigators concluded that the Charité artificial disc successfully functioned as an intervertebral spacer, achieving and maintaining disc space height more effectively than the fusion control during the first two years of follow-up. These findings further contribute to the reasonableness of the Charité device as a treatment for patients with DDD.

7. Similar Complication Rates to Fusion

In 2004, Geisler, et al. reported on the rate of neurological complications of Charité disc replacement as compared with fusion, based on data obtained during the IDE study.³² The investigators found that neurological status was equivalent between the two groups at 6, 12, and 24 months postoperatively. Investigators also found that the number of patients with major, minor, or other neurological complications was extremely low, and was statistically equivalent between the investigational and control groups.
Moreover, investigators found a greater incidence of both major and minor complications in the fusion group at 0 to 42 days postoperatively. Accordingly, the investigators concluded that the Charité results in no higher incidence of neurological complications compared with fusion. Indeed, at the June 2, 2004 FDA Orthopedic and Rehabilitation Devices Panel meeting on the Charité device, a voting panelist, Dr. Choll Kim (Assistant Professor Spine Surgery, Department of Orthopaedic Surgery, University of California, San Diego), commented, “I do want to echo also that the complication rate is surprisingly low and I'm impressed at how low they both are.”³³

Additionally, CMS’ presentation of the data clearly shows that the percentage of device failures in the fusion group was more than twice that of the control group. No cases of prosthetic dislodgement, significant subsidence, or prosthetic loosening were reported by either of the two largest centers in the Charité IDE study at 24 months follow-up.³⁴ Similarly, Guyer, et al. noted that there had been no published reports of device failure or displacement from the spinal column. Dr. Sanjiv Naidu (Associate Professor of Orthopaedic Surgery, Department of Orthopaedics and Rehabilitation, Pennsylvania State University, Hershey Medical Center), a voting panel member, commented on the Charité complication rates during the Orthopedic and Rehabilitation Devices panel meeting on the results of the Charité IDE study. Dr. Naidu noted: “[i]t appears as if device related complications including anterior/posterior migration is less than 1 percent. In addition, the sponsor has conducted an excellent study where they have shown a significant improvement in objective outcomes, including the ODI and the VAS.” Thus, similar complication rates, combined with improvements in function and pain, demonstrate that the Charité is reasonable and necessary for certain patients.

8. Durability and Longevity

Thus far, the Charité has exhibited an excellent record of durability, with 10 to 17 year follow- up data available. In addition, members of the orthopedic community stress the potential for the Charité disc to reduce the risk of future surgery necessitated by adjacent segment degeneration after fusion. For example, Dr. Paul McAfee noted that over the course of 10 years, there is a 25% chance that the patient will require fusion at an adjacent segment vertebral level.³⁵ As follow-up data have shown the longevity of the Charité for at least 10 years, Dr. McAfee noted that avoiding the need for fusion for at least this long by treatment with the Charité disc would be considered a success by most patients. Panel member Dr. Fernando Diaz (Professor of Neurosurgery, Wayne State University) concurred with this assessment, stating: “Even if we gain 10 years of extension on the function of a disc, I think we have provided a sufficient opportunity for the individual not to have a fusion that perhaps would occur spontaneously or that may be induced by the introduction of mechanical devices, which we have already approved.” Thus, the Charité provides patients with the benefit of a device that has shown good results with respect to wear and longevity, as well as the potential for a decreased likelihood of future surgery due to adjacent segment degeneration.

B. Extensive European Clinical Data Support the Safety and Effectiveness of the Charité Implant

In addition to the IDE results, long-term results for the Charité have been published based on the European experience with the device. In 2005, Lemaire, et al. reported on the clinical and radiographic outcomes for 100 patients implanted with the Charité disc and followed for a minimum of 10 years.³⁶ A total of 147 prostheses were implanted with 54 one- level and 45 two-level procedures, and 1 three- level procedure. Clinically, 90% had an excellent or good outcome. 91.5% of patients eligible to return to work did so, including 63.2% of those working in heavy labor returning to the same job. Results also demonstrated excellent flexion/extension and lateral range of motion with no significant complications. Lemaire reported no device failures in this or an earlier series. David reported excellent to good clinical outcome in 75% of his series of 92 patients with a 5-year follow-up.³⁷ Zeegers, et al. discussed the results for 50 patients in a Dutch series with a 2-year follow-up, reporting good results in 70% of patients.³⁸ Similarly, Cinotti, et al. reported excellent or good clinical outcomes in 70% of cases in an Italian study of 46 patients.³⁹

At its June 2, 2004 meeting several members of the Orthopedic and Rehabilitation Devices Panel stressed the utility of the European clinical data in providing longer-term data to support the demonstrated benefits of the Charité device. For example, as Dr. Diaz noted: “[t] here is significant clinical data available in the world literature that indicates the longevity and the effectiveness of this device in the treatment of discogenic disease . . . .” Dr. Diaz continued: “There has been 17 years of use of these devices throughout the world. We are the only country in the industrialized world that does not approve its use yet.”

C. FDA and Orthopedic Surgery Community Support for the Charité

Both FDA and the orthopedic community have expressed clear support for the availability of the Charité device as an effective, beneficial, and innovative alternative for patients suffering from DDD. The Orthopedic and Rehabilitation Devices Panel determined that not only was the Charité device safe and effective for clinical use, but that it offered an important technological innovation. The panelists expressed overwhelming support for the Charité as an alternative to fusion. Further, the panel praised the Charité study. One panelist, Dr. Jay Mabrey (Chief, Department of Orthopaedics, Baylor University Medical Center), stated, “I felt that the company went far and above what it had to do to prove that this was a safe and effective device . . . .” ⁴⁰ The Charité trial was a well-organized, randomized, controlled study with a complex four-prong endpoint, which was clearly defined and met. Thus, the available data show very clearly that the Charité represents a technological innovation that brings clear benefits to patients suffering from DDD. Not only have the observed complications been comparable to fusion, but the Charité also provides additional advantages in function, pain, speed of pain relief, patient satisfaction, lower incidence of post-surgery narcotic use, range of motion, and maintenance of disc height. Taken together these factors demonstrate the importance of having the Charité available as a treatment for patients with DDD. Therefore, we recommend that CMS not issue an NCD at the present time and continue to allow local Medicare contractors to make coverage decisions. We believe the data clearly demonstrate that the Charité disc is a reasonable and necessary treatment option for some patients with DDD.

III. IF CMS ISSUES A NON-COVERAGE DECISION, IT SHOULD APPLY ONLY TO CHARITÉ’S USE IN THE ELDERLY

A. Any CMS Non-Coverage Decision Should Be Limited Only to Charité.

We disagree strongly with CMS’s proposed non- coverage decision regarding the Charité lumbar artificial disc. In the event that CMS decides to move forward with this non-coverage decision, however, the scope of non-coverage must be limited to the Charité. A number of devices that fall into the category of lumbar artificial discs are currently under development. These devices involve substantial and important differences, both in device design and clinical study design, which may potentially decrease the incidence of certain adverse events, improve patient outcomes, and provide even stronger evidence of clinical benefit. In light of the substantial differences presented by completed and ongoing studies of these other artificial disc products, the scope of CMS’ non-coverage decision must be limited. To functionally exclude these devices from coverage without reviewing and considering the data for these new devices would do a serious disservice to many patients covered by Medicare. We recognize that CMS references these future devices in its proposed decision. Specifically, CMS notes that “we anticipate that when other lumbar spinal disc implants receive approval from the FDA that CMS will, by external request or internal direction, open this NCD for reconsideration with a thorough review of the evidence for each new disc implant.” We strongly urge CMS to reconsider the adverse impact on patient care that will result by approaching the issue of coverage in this manner. A non-coverage decision that functionally would exclude all new devices until reconsideration would mean even more delay before patients are able to take advantage of these advances in technology. Rather than forcing patients to wait until the potentially lengthy process of reconsideration is concluded, CMS should recognize the benefit to patients that stems from allowing physicians to use newly developed technology in an appropriately selected patient.

In fact, should CMS issue a final non-coverage decision, it will soon face the need for reconsideration. As mentioned above, one of the new devices, the ProDisc artificial disc, received an approvable letter from the FDA in January 2006. The ProDisc uses two cobalt chromium molybdenum alloy endplates with a ultra high molecular weight polyethylene core. Published data concerning the use of this artificial disc are quite promising. Due to the fact that this device has been used for many years in other parts of the world, long term data now are becoming available. Tropiano et al. provided an assessment of the clinical and radiographic results for 64 patients who underwent an artificial disc replacement with the ProDisc. ⁴¹ The results, assessed 7 to 11 years after surgery, showed that 41 of the 55 patients with sufficient follow up had excellent or good results.

In 2005, investigators reported interim results for the first 78 randomized IDE study patients (56 ProDisc II and 22 fusion) with 18- to 24- month follow-up. ⁴² Twenty-six patients were treated for one-level disc disease, and 52 patients were treated for two-level disc disease. Disc replacement patients demonstrated significantly greater reduction in VAS pain and disability, at 3 months, as compared to fusion patients. ODI scores were significantly reduced from preoperative in both ProDisc and control groups at all follow-up intervals from 6 months to 24 months. Patients in the investigational group showed a significant decrease in pain, as measured by the VAS, as early as 6 weeks after surgery. This significant reduction in pain was maintained at approximately a 50% decrease from preoperative levels at the 3-, 6-, 12-, 18- and 24-month intervals. The investigational group also reported more rabid increase in functional ability as compared to the control group. A significant improvement generally was not observed in fusion patients until 6 months. An analysis of the sagittal angular motion revealed an increase in motion from preoperative to the 6- month follow-up for the L4-L5 segment in patients treated with disc replacement at this level. This motion was maintained at 12 months. Results for patients treated at the L5- S1 segment were similar. The demonstrated post- operative pain reduction results, functional improvement demonstrated by ODI results, and shorter post-operative time period before observation of improvement, provide further evidence that artificial discs offer the potential for improved patient care and treatment.

Stryker’s FlexiCore® Lumbar Intervertebral Disk Replacement (“FlexiCore”), is currently being investigated in a U.S. IDE study and also is expected to receive approval within the next one to two years. Unlike the Charité, which is made from a UHMWPE core and metal endplates, the FlexiCore is entirely metal. This innovation is expected to increase the long-term durability of the device. Additionally, while the Charité study involved a control with the BAK cage alone, the ongoing FlexiCore study uses a control of 360° fusion, i.e., requiring both anterior and posterior intervention. While, as discussed in section II above, the Charité study clearly demonstrated benefit, the differently designed FlexiCore study is expected to provide even stronger evidence of benefit to patients who suffer from DDD.

Another lumbar artificial disc undergoing an IDE study is Medtronic’s Maverick. The Maverick is also a metal-on-metal design. Le Huec et al. reported results from a prospective study of 64 subjects who underwent artificial disc replacement with the Maverick. ⁴³ Patients were required to have symptomatic degenerative lumbar discopathy as evidenced by radiography and MRI. According to FDA criteria for ODI scores, the study showed a 75% success rate. Additionally, the mean VAS score for low back pain improved from 7.6±1.7 to 3.2±1.8 at two years. These preliminary results suggest that the Maverick disc also will provide significant benefits to patients.

Clearly the data for these approvable and not- yet-approved devices are quite promising. If CMS were to decide that no artificial lumbar disc should be covered, then once these devices are approved by the FDA, patients will be required to wait even longer to receive the benefits of this new technology. Numerous patients have already submitted comments on this proposed decision. Those comments make clear the difference in quality of life that these devices can make. Once a new device is approved, patients will be faced with choosing between waiting until CMS reconsiders its previous coverage decision, and undergoing fusion. For many patients, fusion may not be the optimal treatment, and once performed, it is irreversible and will foreclose other future treatment options. On the other hand, the time which CMS takes to reconsider its previous non-coverage decision, could represent a long period of pain and loss of function for many patients. Those patients should be allowed to benefit from the development in new technology as soon as the FDA determines that the new device is safe and effective. Until such time as CMS chooses to evaluate evidence for a new disc, the decision should be left to local contractors.

Additionally, forcing developers of these new devices to wait until CMS reconsiders the NCD represents a serious disincentive for development of new artificial disc technology. This disincentive, in turn, seriously disfavors patients. As CMS is well aware, the NCD will impact not only the local Medicare contractors, but is also likely to be implemented by most private insurers. Thus, in practice, this means that these new devices must go through the rigorous FDA approval process and then wait an additional, quite possibly lengthy, time period before physicians will be able to use the devices in appropriate patients. Of course, there will be a few patients who will be able to pay for such a procedure out-of-pocket, but the vast majority of people in need of a surgical approach to relief from DDD will not be able to benefit from total disc replacement technology. Thus, not only will manufacturers be discouraged from developing new artificial lumbar discs, leading to less advances in treatment for DDD, but patients without the means for out-of-pocket payment will be forced to either opt for an irreversible fusion procedure, or to wait even longer before treatment with a new device will be available.

For these reasons, we strongly urge CMS to limit the scope of the proposed decision to the Charité device and allow patients to benefit from advances in artificial disc technology as they become available through the FDA approval process.

B. CMS’s Non-Coverage Decision Should Be Limited to Use in the Elderly.

In the event CMS decides to move forward with the non-coverage decision, the decision must also be limited to use in elderly patients. As CMS notes in the proposed Decision Memorandum, Very few patients over the age of 65 have been treated with the Charité disc technology. Therefore, there is insufficient evidence for those over age 65 to determine net health benefit, with the suggestion that the Charité disc is not indicated in this population for a variety of reasons.

Although there is little data regarding use of the Charité device in patients over 65, there is a great deal of data regarding the use of lumbar artificial discs in patients under 65. As discussed above, in section II, the data do demonstrate that the Charité device is a reasonable and necessary treatment option for certain patients. Questions concerning the device’s efficacy and safety in patients over 65 should not prevent younger patients’ access to this technology.

CMS’s April 2005 Draft Guidance on “Factors CMS Considers in Making a Determination of Coverage with Evidence Development” notes that “CMS is committed to ensuring that advances in medical technology are available for its beneficiaries . . .” We urge CMS to consider that commitment in light of this particular issue. The majority of the concerns expressed in CMS’ proposed Decision Memorandum concern use in the elderly. Indeed, CMS’ conclusions appear to be based primarily on consideration of the device’s use in the elderly. Although the studies completed to date did not focus on the elderly, the robust data concerning use in patients under 65 demonstrate that it is a reasonable and necessary treatment for certain patients.

For these reasons, if, against our strong recommendations, the agency decides to move forward with a national non-coverage determination, we strongly urge CMS to limit the scope of the proposed decision to use in patients over 65 and allow other patients to benefit from use of lumbar artificial discs.

IV. CONCLUSION

In closing, the available data support the conclusion that use of lumbar artificial discs is reasonable and necessary for treatment of some patients suffering from DDD. Nonetheless, we understand that CMS does not find the data sufficient to support a positive coverage decision. Thus, we request that CMS refrain from issuing a national decision at all and allow local contractors to make coverage decisions. Given the limitations and complications associated with spinal fusion, patient care is significantly enhanced by having alternative treatments available to the greatest extent possible. If CMS intends to move forward with the proposed Decision Memorandum, we alternatively urge CMS to limit the scope of the non-coverage decision to the Charité specifically and/or use of the device in patients over age 65.

Thank you for your attention to this very important matter. We appreciate this opportunity to comment on this draft decision and we look forward to working with CMS on future coverage issues.

Sincerely,
Janice M. Hogan, Esq.

ENDNOTES:

1. http://www.cms.hhs.gov/mcd/viewdraft decisionmemo.asp?id=170.
2. Denozière, G., Ku, D.N. (2006) Biomechanical comparison between fusion of two vertebrae and implantation of an artificial intervertebral disc. J Biomechanics 39: 766-75.
3. Baldwin, N.G. (2002) Lumbar disc disease: the natural history. Neurosurg Focus 13(2):1-4.
4. Moore, K.R., Pinto, M.R., Butler, L.M. (2002) Degenerative disc disease treated with combined anterior and posterior arthrodesis and posterior instrumentation. Spine 27(15):1680- 86.
5. Hacker, R.J., Cauthen J.C., Gilbert T.J., et al. (2000). A prospective randomized multicenter clinical evaluation of an anterior cervical fusion cage. Spine 25(20):2646-55.
6. Guyer, R.D., Ohnmeiss, D.D. (2003) Intervertebral disc prostheses. Spine 28:S15- S23.
7. Anderson, P.A., Rouleau, J.P. (2004) Intervertebral disc arthroplasty. Spine 29 (23):2779-86.
8. Id.
9. SSA § 1862(a)(1).
10. 68 Fed. Reg. 55634, 55635 (Sept. 26, 2003) (stating that CMS does not plan to develop a proposed rule based on the May 16, 2000 notice of intent regarding criteria for making coverage decisions.)
11. SSA § 1862(l)(1).
12. See Draft Guidance for the Public, Industry and CMS Staff: Factors CMS Considers in Opening a National Coverage Determination, March 9, 2005 (“the agency has generally interpreted "reasonable and necessary" to include the meaning that the item or service should improve health outcomes overall for Medicare beneficiaries”).
13. See, e.g., Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG- 00250R), Feb. 21, 2006, http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp? id=160.
14. See, e.g., MCAC Meeting, Treatments for Vertebral Body Compression Fractures, May 24, 2005, available at http://www.cms.hhs.gov/mcd/viewmcac.asp? where=index&mid=29.
15. See Proposed Decision Memo for Lumbar Artificial Disc Replacement, Appendix A: General Methodological Principles of Study Design, at 3 (“Generally, an intervention is not reasonable and necessary if its risks outweigh its benefits.”).
16. See PMA Summary of Safety and Effectiveness for InFuse™, page 36, http://www.fda.gov/cdrh/pdf/P000058b.pdf. The 57.1% success rate is for the posterior open surgical implantation group that received InFuse. In this study, success was defined to require Oswestry improvement, radiographic evidence of fusion, maintenance or improvement in neurological status, and freedom from reoperation or serious device-related or procedure-related complications.
17. Aetna, Intervertebral Disc Prostheses Clinical Policy Bulletin (No. 0591), January 13, 2006, available at http://www.aetna.com/cpb/data/CPBA0591.html.
18. Transcript, FDA Orthopedic and Rehabilitation Devices Panel Meeting (June 2, 2004), available at http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4049t1.htm.
19. It should also be noted that while CMS’ Decision Memorandum criticizes the selection of a control in this study, it does not appear that CMS has issued any national non-coverage decision with respect to stand-alone interbody fusion cages. Thus, this Decision, if issued, would lead to the paradoxical result that the Charité would not be covered, but the control that is criticized as suboptimal and no longer consistent with the standard of care apparently could continue to be covered.
20. Blumenthal, S., McAfee, P., Guyer, R., Hochschuler, S.H., Geisler, F.H., Holt, R.T., Garcia, R., Regan, J.J., Ohnmeiss, D.D. (2005) A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the Charité artificial disc versus lumbar fusion. Part I: evaluation of clinical outcomes. Spine 30(14):1565-1575.
21. Id.
22. Id.
23. Regan, JJ (2005) Clinical Results of Charité Lumbar Total Disc Replacement. Orthop 24. Id. 25. Transcri
pt. June 2, 2004 Panel Meeting.
26. Blumenthal, S., McAf ee, P., Guyer, R., Hochschuler, S.H., Geisler, F.H., Holt, R.T., Garcia, R., Regan, J.J., Ohnmeiss, D.D. (2005) A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the Charité artificial disc versus lumbar fusion. Part I: evaluation of clinical outcomes. Spine 30(14):1565-1575.
27. Regan, J.J. (2005) Clinical Results of Charité Lumbar Total Disc Replacement. Orthop Clin N Am 36:323-340.
28. Blumenthal, S., McAfee, P., Guyer, R., Hochschuler, S.H., Geisler, F.H., Holt, R.T., Garcia, R., Regan, J.J., Ohnmeiss, D.D. (2005) A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the Charité artificial disc versus lumbar fusion. Part I: evaluation of clinical outcomes. Spine 30(14):1565-1575.
29. McAfee, P.C., Cunningham, B., Eng, M., Holsapple, G., Adams, K., Blumenthal, S., Guyer, R.D., Dmietriev, A., Maxwell, J.H., Gegan, J.J., Isaza, J. (2005) A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the Charité artificial disc versus lumbar fusion. Part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with Clinical outcomes. Spine 30(14):1576-1583.
30. SariAli, E, Lemaire, JP, Pascal- Mousselard, H, Carrier, H, Skalli, W (2005) In vivo study of the kinematics in axial rotation of the lumbar spine after total i intervertebral disc replacement: long-term results: a 10-14 year follow up evaluation. Eur Spine J 21:1-10.
31. McAfee, P.C., Cunningham, B., Eng, M., Holsapple, G., Adams, K., Blumenthal, S., Guyer, R.D., Dmietriev, A., Maxwell, J.H., Gegan, J.J., Isaza, J. (2005) A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the Charité artificial disc versus lumbar fusion. Part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine 30(14):1576-1583.
32. Geisler, FH, Blumenthal, SL, Guyer, RD, McAfee, PC, Regan, JJ, Johnson, JP, Mullin, B (2004) Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc. J Neurosurg (Spine 2) 1:143-154.
33. Transcript. June 2, 2004 Panel Meeting.
34. Guyer RD, McAfee PC, Hochschuler SH, et al. Prospective randomized study of the Charité artificial disc : data from two investigational centers. Spine Journal 4 :252S-259S, 2004.
35. Id.
36. Lemaire, J-P., Carrier, H., Ali, E-H S., Skalli, W., Lavaste, F. (2005) Clinical and radiological outcomes with the Charité artificial disc: a 10-year minimum follow-up. Spinal Disord Tech 18(4):353-359.
37. David, T (2000). Lumbar disc prosthesis: five year follow-up study on 96 patients. Presented at the 15th Annual Meeting of the North American Spine Society (NASS). New Orleans, Louisiana.
38. Zeegers, WS, Bohnen, LM, Laaper, M, et al. (1999) Artificial disc replacement with the modular type SB Charité III: 2-year results in 50 prospectively studied patients. Eur Spine J 8:210-217.
39. Cinotti, G, David, T, Postacchini, F (1996) Results of disc prosthesis after a minimum follow up of 2 years. Spine 21:995- 1000.
40. Transcript. June 2, 2004 Panel Meeting.
41. Tropiano, P., Huang, R.C., Girardi, F.P., Cammisa, F.P., Marnay, T. (2006) Lumbar total disc replacement. J Bone & Joint Surg 88:50-64.
42. Delamarter, R.B., Bae, H.W., Pradhan, B.B. (2005) Clinical results of ProDisc-II lumbar total disc replacement: report from the United States Clinical Trial. Orthop Clin N Am 36:301-313.
43. Le Huec, J.C., Mathews, H., Basso, Y., Aunoble, S., Hoste, D., Bley, B., Friesem, T. (2005) Clinical results of Maverick lumbar total disc replacement: two year prospective follow-up. Orthop Clin N Am 36:315-322.

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Artificial disc technology has been very beneficial for the younger population as it preserves motion of the spine and decreases adjacent level disease. Patients are able to return to work and activities of daily living faster than lumbar fusion. Fusion and disc replacement are not for the same patients as candidates come from different subsets based on pre-op testing for the spine pain generator. Disc replacement is not for the elderly but many private insurances are linked to Medicare approval and hence, the younger patients will fail to benefit from disc replacement technology if non-coverage of this procedure is chosen.

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Dear Sir or Madam, The recent CMS decision to deny coverage for the Charite artificial lumbar disc is quite unfortunate. As a spine surgeon working in an academic medical center, I have found that the application of artificial disc technology has produced, in select patients, superior clinical results when compared to traditional fusion surgeries. While disc replacement may not be appropriate for all patients, the global decision to deny coverage will restrict access for certain patients who could benefit in a substantive manner. Furthermore, it does not appear that US surgeons have attempetd to apply artificial disc technology with loose indications or in a manner that will result in excessive Charite implantations. I would strongly urge you to reconsider this decision and instead render no decision at this time until further data can be obtained on the efficacy of artificial disc technology in the medicare population. Respectfully,

Michael Y Wang, MD
Spine Director
The University of Southern California
Los Angeles, California

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I AM AN ORTHOPAEDIC SPINE SURGEON WHO HAS PERFORMED QUITE A FEW ARTFICIAL DISC REPLACEMENTS WITH EXCELLENT CLINICAL RESULTS AND VERY FEW COMPLICATIONS. THESE PROCEDURES WERE DONE IN YOUNG PATIENTS. THIS PROCEDURE IS NOT INDICATED FOR THE MAJORITY OF MEDICARE PATIENTS. THE EXCEPTION IS YOUNGER DISABLED PATIENTS ON MEDICARE. I HAVE DONE ONE OF THESE PATIENTS WITH SIGNIFICANT IMPROVEMENT OF HIS PAIN AND INCREASE IN HIS ACTIVITY LEVEL. THE FDA CRITERIA CLEARLY OUTLINE THE APPROPRIATE PATIENTS FOR THIS PROCEDURE. THIS TECHNOLOGY IS DESIGNED TO PRESERVE MOTION AND IS AN ALTERNATIVE TO FUSION. JUST LIKE IN HIP AND KNEE REPLACEMENTS, ARTIFICIAL DISC REPLACEMENTS WILL IMPROVE WITH TIME, BUT ONLY IF WE HAVE CONTINUED ACESS TO PATIENTS. THE EFFORT BY CMS REPRESENTS A SERIOUS THREAT TO MOTION SPARING TECHNOLOGY.

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The American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), the AANS/CNS Section on Spine and Peripheral Nerves and the North American Spine Society (NASS), representing physicians and other health care providers caring for patients with spine disease, appreciate the opportunity to comment on the Proposed Decision Memorandum regarding lumbar artificial disc replacement posted on the Centers for Medicare and Medicaid Services' (CMS) Coverage website on February 15, 2006. Our organizations believe that it is premature for CMS to render a definitive national coverage determination for this procedure and we therefore urge you to reverse your decision.

We fear that if the agency does implement a non-coverage decision, many patients - both Medicare beneficiaries and others who would benefit from this treatment, may suffer unnecessarily if this surgical option is not available to them. There are a number of reasons why a non-coverage determination is premature and therefore inappropriate at this time.

We have reviewed the material listed in the NCD for Lumbar Artificial Disc Replacement with the Charite device. As President of Coastal Neurosciences, d/b/a Coastal Physicians & Surgeons, PC, I am expresssing the opinion of Dr. Andrew Glass, Dr. Robert Sabo, and myself, all Board Certified Neurosurgeons with expertise in spinal neurosurgery. We disagree strongly with the recommendation of the panel regarding non-coverage. In our experience, with what we believe to be a significant number of implants, strict adherence to selection criteria is critical to obtaining good results. We have had no adverse events with the implants thus far, and no patients have required re-operation. Admittedly, none of our patients are above age 65, as this population is generally excluded from the procedure by any of a number of anatomic criteria. A national NCD by CMS on this procedure will have extensive effect on the non-Medicare population who are candidates for this surgery, as many of the third party payors will then choose to follow the CMS determination and this technology will be denied to the population that is most suited for it in appropriate cirumstances. In addition CMS has already stated in the material that it expects to re-open the NCD when additional devieces are available on the market. We believe that a non-coverage determination at the present time is inappropriate, and potentially prejudicial to the patient population this procedure will benefit.

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The American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), the AANS/CNS Section on Spine and Peripheral Nerves and the North American Spine Society (NASS), representing physicians and other health care providers caring for patients with spine disease, appreciate the opportunity to comment on the Proposed Decision Memorandum regarding lumbar artificial disc replacement posted on the Centers for Medicare and Medicaid Services' (CMS) Coverage website on February 15, 2006. Our organizations believe that it is premature for CMS to render a definitive national coverage determination for this procedure and we therefore urge you to reverse your decision.

We fear that if the agency does implement a non- coverage decision, many patients both Medicare beneficiaries and others who would benefit from this treatment, may suffer unnecessarily if this surgical option is not available to them. There are a number of reasons why a non-coverage determination is premature and therefore inappropriate at this time.

The American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), the AANS/CNS Section on Spine and Peripheral Nerves and the North American Spine Society (NASS), representing physicians and other health care providers caring for patients with spine disease, appreciate the opportunity to comment on the Proposed Decision Memorandum regarding lumbar artificial disc replacement posted on the Centers for Medicare and Medicaid Services' (CMS) Coverage website on February 15, 2006. Our organizations believe that it is premature for CMS to render a definitive national coverage determination for this procedure and we therefore urge you to reverse your decision.

We fear that if the agency does implement a non-coverage decision, many patients - both Medicare beneficiaries and others who would benefit from this treatment, may suffer unnecessarily if this surgical option is not available to them. There are a number of reasons why a non-coverage determination is premature and therefore inappropriate at this time.

The American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), the AANS/CNS Section on Spine and Peripheral Nerves and the North American Spine Society (NASS), representing physicians and other health care providers caring for patients with spine disease, appreciate the opportunity to comment on the Proposed Decision Memorandum regarding lumbar artificial disc replacement posted on the Centers for Medicare and Medicaid Services' (CMS) Coverage website on February 15, 2006. Our organizations believe that it is premature for CMS to render a definitive national coverage determination for this procedure and we therefore urge you to reverse your decision.

We fear that if the agency does implement a non- coverage decision, many patients both Medicare beneficiaries and others who would benefit from this treatment, may suffer unnecessarily if this surgical option is not available to them. There are a number of reasons why a non-coverage determination is premature and therefore inappropriate at this time.

Citizen’s Health Care Association (CHCA) is responding to the request by the Centers for Medicare and Medicaid (CMS) for public comments on its Proposed Decision Memo (PDM) calling for a national non-coverage determination for the CHARITÉ™ Artificial Disc.

Knowing that CMS is specifically interested in comments that include evidence that was not reviewed by CMS in the PDM or how CMS assessed the evidence that was included in the PDM, our comments will focus primarily on such issues.

Initially, CHCA wants to point out that the CHARITÉ™ Artificial Disc (CAD) is a technology designed to preserve motion. It is an alternative to lumbar fusion. In order to preserve the value of this technology, patients must have continued access to the CAD. CMS could preserve access to the CAD while protecting patients by allowing coverage with evidence. Indications for Use and Qualifying Criteria that address contraindications will limit utilization in the elderly Medicare population. Regardless, CMS should undertake continued efforts to obtain additional data on this technology. For example, there are at least three Food and Drug Administration (FDA) Investigational Device Exemption (IDE) lumbar disk studies which have completed enrollment and are pending FDA panel review. This will more than triple the data set available for review and in turn allow for more appropriate scientific review. The effort by CMS to bar coverage to the CAD seems a bit premature and perhaps inappropriate (considering a small minority of patients who meet the criteria for the CAD fall within the purview of CMS) and poses a serious threat to the continued development and implementation of motion preserving technology.

There are patients both younger and older than 65 who would make good candidates for this device. There are disabled people under 65 enrolled in Medicare who would be well-suited candidates for the CAD. Often one of the main reasons people under 65 are on Medicare is because of back pain. The cost-savings for just one patient who gets off disability because of the CAD is not something to ignore. While the CAD is not indicated for the vast majority of patients over 65 years old, some of those patients may benefit. It is impossible to determine that this device is inappropriate for an entire population based on age alone. Further, it is inappropriate to deny coverage to qualified disabled patients under the age of 65 simply because they are in the Medicare population. The key is to focus on proper patient selection. The FDA criteria detail proper patient selection. Many patients who meet the FDA criteria must remain active and need to work to provide for dependents. A positive coverage decision by CMS for this device will increase the employability and mobility of qualified patients and have a positive impact on the lives of countless people.

CHCA has questions about the evidence that CMS used in the evaluation. First, CMS concludes that patient indications are not well defined. CMS uses the inconsistencies of the case series to make its point. However, it is important to note that the IDE study was commenced to address this concern. With FDA approval, those indications were defined. Second, the risks of anterior approach surgery are noted, without acknowledging that this approach is routinely used for anterior lumbar interbody fusion surgery. Third, the risks of vascular injury in revision surgery are cited, without acknowledging that primary revision strategy is a posterior approach.

Further, there are problems with some of the case series cited in the CMS PDM. Among those cited are Griffith et al (1994), Cinotti et al (1996), Zeegers et al (1999), and Caspi et al (2003). The Griffith paper does not separate SB I and SB II data from SB III data. Further, it reports outcomes that include 58 prototype devices of different design and of different materials that were never made commercially available. The Zeegers paper reported on 50 patients with 2-year follow-up. As admitted in the conclusion, the indications for total disc replacement in the late 1990’s were still widely variable and did not represent the relatively narrow on-label FDA indications for the CAD. Finally, the Cinotti and Caspi papers (as did the Zeegers and Griffith papers) reported results from a time when indications were highly variable, a limited number of device component sizes were available, and basic, rudimentary instrumentation was utilized.

A review paper by de Kleuver et al (2003) is cited. This literature review was performed in 2002 and published in 2003, over a year before the results of the prospective, randomized, controlled IDE trial of the CAD were made public, and over two years before the results were published in the peer-reviewed literature, Spine. The de Kleuver article is outdated.

The paper by van Ooij et al (2003) reporting complications in 27 patients is cited along with the fact that the 27 patients are from an original cohort of 500 patients. However, it is not mentioned that this yields a known complication rate in these patients of 5.4%. This is a lower complication rate than in the IDE study. Also, not fully taken into account is the fact that these cases took place when the indications for lumbar disc replacement were highly variable, with a limited number of device sizes and with basic first generation instrumentation. Times have changed and none of these circumstances remain today.

It is important to note that all of the papers named above were published prior to the completion of the IDE study and publication of the results in Spine.

The paper by Putzier et al (in the 2005 online publication European Spine) is given significant attention in the PDM because it represents the longest published follow-up of patients implanted with the CAD. Tables in the memo show a distinction between SB I, II, and III models of the device but the PDM fails to take into account that this is the earliest clinical use of the SB III device. Indications, sizing, and instrumentation are all important distinctive issues compared to what is known and in use in 2005. Dr. Karin Büttner-Janz disputes the accuracy of these data from the Charité hospital as it does not match with her data and these were her patients.

The Lemaire et al (1997) and David (2002) pieces are criticized for reporting clinical results without the use of the Owestry Disability Index (ODI), visual analogue scale (VAS), or the SF-36 Health Survey scores. At the time data collection began on these patients in 1989, none of these clinical outcome instruments was validated or in widespread use to measure pain and function in low back pain patients.

No formal training was available at the time these early studies were conducted. Since the FDA approved the CAD, all spine surgeons who implant the device in the U.S. must undergo a training course sponsored by DePuy Spine at the Center for Spine Arthroplasty in Cincinnati. This comprehensive course includes didactic and hands-on training.

Throughout the PDM, revision rates from various studies are cited. However, revision rates for lumbar fusion are equally high as reported by McAfee (North American Spine Society, 2005) and as reported by Medtronic Sofamor Danek (INFUSE® SS&E, Federal Register, a 10.4% re-operation rate for patients receiving LT-Cages and INFUSE for lumbar fusion, Federal Register, May 26, 2004).

The IDE study of the CAD is a landmark study in the history of spine surgery and represents the only prospective, multi-center, randomized, controlled study to date of two different surgical treatments for low back pain. The Orthopedics & Rehabilitation Panel of the Center for Devices and Radiological Health (CDRH) performed an exhaustive review of the results of the study and unanimously recommended approval of the CAD.

In closing, CHCA asks CMS to tread carefully here. While we do not advocate approving CAD coverage for all Medicare patients, we do believe coverage should be provided for certain patients. This technology is too important to summarily deny coverage when certain criteria can be relied upon to rule out inappropriate candidates.

Thank you for the opportunity to participate in this process. CHCA is willing to answer any questions and provide additional input.

Nathan Adams
Executive Director
Citizens Health Care Association

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Medicare and Medicaid should cover the procedure for lumbar disc arthroplasty.

1. Other artificial installations such as hip and knee are similar and are covered

2. The approval of such a procedure will lessen later claims because of the lessening of adjacent disc problems associated with the alternative

3. The success rate of the operation will increase with it's application which approval will spawn

4. With increased success disability claims will decrease and with it claims against Social Security for Disability

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AdvaMed appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) draft National Coverage Decision (NCD) on lumbar artificial disc replacement. Our comments will not be focused on the technology of artificial discs per se. Rather, we will focus on the proposal to non-cover a new technology on the basis that there is insufficient evidence to conclude that the technology is reasonable and necessary.

As you know, we follow Medicare coverage activity very closely because of the impact it has on beneficiary access to state-of-the-art medical care. AdvaMed’s goals are for a coverage process that is timely, open, and predictable. CMS has made progress in recent years in improving the coverage process. The web postings, solicitation of public comments on draft decisions, and open meetings have made the process more transparent. However, we believe more work is needed to make the national coverage process more predictable and to allow Medicare beneficiaries access to important new technologies.

We have noted that national non-coverage determinations are increasingly being made where CMS declares the evidence to be inadequate, insufficient, or unavailable to conclude that the technology is reasonable and necessary. We recognize that for new technologies and procedures, early evidence that fully satisfies safety and efficacy standards is not always as broad as CMS might like. There may be no consensus in the literature or among medical experts concerning the care that may be best in every individual situation and circumstance. However, Medicare coverage processes that force early assessment should bear in mind that the absence of broad, conclusive evidence does not equate to the absence of clinical value. CMS should not make national non-coverage decisions unless it has definitive clinical information that a product or service is not effective or that it causes patient harm. Deciding not to cover promising technologies due to “insufficient” evidence undercuts beneficiary access to appropriate care by limiting patient and physician choice of procedure, technology, and medicine. Such coverage decisions actually make it more difficult for Medicare beneficiaries to benefit from these technologies, more difficult for real world studies to be conducted, and more difficult for evidence to be gathered.

CMS has been assuring patients, providers and manufacturers that its “coverage with evidence” initiative will be used principally to advance coverage more quickly for promising technologies. CMS’s most recent proposed non-coverage decision suggests that rather than making strides to improve access, CMS may use evidence requirements to create hurdles to access. We believe that national non-coverage determinations are not an appropriate approach where the early evidence is not as complete as CMS might want with respect to new technologies. Rather than denying beneficiary access to promising new technologies where the evidence is not yet broad, CMS should allow local medical directors to weigh the evidence, factor in local circumstances, and allow patients access to services and procedures.

In short, AdvaMed recommends that CMS reconsider its approach to coverage of new technologies that provide benefits for seniors and disabled Americans but have evidence that is still evolving. We look forward to working with CMS to ensure patient access to such important medical technologies.

Sincerely,

Ann-Marie Lynch

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Medtronic Sofamor Danek (MSD) appreciates the opportunity to comment on the proposed National Coverage Determination (NCD) for lumbar artificial disc replacement. Our comments reflect the belief that lumbar disc arthroplasty is a viable clinical option for well-selected Medicare patients and that denying access to this technology would unduly influence commercial payers.

In his original request to CMS, Dr. Deyo expressed his concern about the use of the CHARITE„ Artificial Disc Replacement in the lderly Medicare beneficiary given that the disc is contraindicated for osteoporosis, was not studied in patients over the age of 60, and that the primary indicated population is a young, active patient. We agreed in our comment letter dated September 16, 2005 that the primary population for disc arthroplasty is not the elderly Medicare members. However, there are clinically-appropriate individuals within this population who meet the indications for the technology and who would receive its resulting clinical benefits.

Patient-specific condition(s) should be the most important factor in determining which treatments are appropriate and most likely to provide the greatest clinical benefit. Therefore, we believe that CMS should continue to allow local Medicare contractors the authority to cover these procedures on a case-by-case basis when the beneficiary meets the indications for use based on the judgment of trained physicians.

A negative coverage decision by CMS would not only deny access to this technology for its members who meet the appropriate clinical indications, but would also have a negative effect on commercial payer coverage decisions. Disc arthroplasty is not, and probably never will be, a significant issue for CMS. Still, by enacting a NCD for these procedures, CMS will exert an undue influence on the commercial payers when Medicare beneficiaries will account for so few of the recipients of the technology. As you know, these payers look to Medicare as the "bell weather" and will find it much easier to deny access to their members if Medicare is also not covering the technology.

Again, we encourage CMS to thoughtfully consider the overwhelming response received in September from practicing spine surgeons and their professional societies regarding the procedural value and patient care impact of disc arthroplasty. We look forward to continued dialogue with CMS on the value of this and similar technologies and appropriate patient access to them.

Sincerely,

Michael K. McCormack
Senior Manager, Reimbursement Planning
Medtronic Sofamor Danek

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I was one of the principal investigators in the US for the Pivotal charite lumbar disc study, so I have patients who are over 5 years out. I have been able to see first hand what a good device this is in the "correctly" chosen patient. The problem I see in my practice is that of the surgical treatment of young patients with low back pain with mild degenerative changes on radiographic imaging. Fusion surgeries in my hands do not offer good results in my hands for these types of patients. I am in the process of looking into the results of disc replacement in these patients with low back pain and minimal findings, I know that in some of my patients in the initial study that they are pain free 5 years post op. I feel that a non coverage decision for this device or surgery would be a big mistake and would deny care for certain patients with severe low back pain. Please take this into consideration,

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On October 26, 2004, the FDA approved the world’s first lumbar artificial disc, the CHARITÉ™ Artificial Disc (DePuy Spine, Raynham, MA) for use in the United States(FDA 2004). In doing so, the FDA followed the recommendation of its expert Orthopaedic and Rehabilitation Devices Panel which on June 2, 2004, unanimously recommended approval(Register 2004). The FDA decision was based on the results of a prospective, randomized, controlled clinical trial comparing lumbar artificial disc replacement to a fusion procedure; and 20 years of world-wide experience. The FDA approval meant that the manufacturer could market the device as safe and effective for the treatment of one-level lumbar DDD in indicated patients at either the L4-5 or L5-S1 level.

This clinical trial was the first in the history of spine surgery to compare two different surgical treatments for lumbar DDD using a multi-center, prospective, randomized, controlled study design – Level I Medical Evidence. The results the study were published in peer-reviewed journals including Journal of Neurosurgery in September 2004(Geisler, Blumenthal et al. 2004), and Spine in July 2005(Blumenthal, McAfee et al. 2005; McAfee, Cunningham et al. 2005). Because of the prospectively specified non-inferiority design of the study and the FDA required a complex success/failure criteria, the primary conclusion of the study for FDA labeling purposes was that clinically, treatment with artificial disc replacement (disc arthroplasty) was at least as good as a fusion procedure.

On February 15, 2006, the Centers for Medicare and Medicaid Services (CMS) issued a proposed non-coverage decision for lumbar artificial disc replacement based on their perception of insufficient evidence that the procedure is safe and effective, beyond the FDA-required evidence and pre-approved FDA study protocol(CMS).

The proposed non-coverage decision by CMS is not only inconsistent with the published FDA analysis, but also contains multiple non-scientific interpretations and logical errors.

A detailed analysis of the clinical measurement variables used in this study, the Oswestery Disability Index (ODI) and Visual analog scale (VAS) scores had almost identical initial mean values. Thus, the randomization worked in this study and no baseline corrections were necessary or used in the analysis of this data reviewed below.

The non-parametric analysis of ODI and VAS scores demonstrated that subjects enrolled in both treatment groups (CHARITÉ™ Artificial Disc and lumbar fusion) had highly significantly lower scores at all follow-up time points compared to baseline, including the two year follow-up (p< 0.001). the improved scores in both groups are: 1) sustained over the two year period; 2) monotonically decreasing; and 3) over twice the difference considered to be of minimum clinical significance(Hagg, Fritzell et al. 2003). This triad makes a placebo effect of surgery for the observed improvement unlikely. Further, inspection of the recovery curves demonstrates significant improvement at six weeks with maintenance out to two years with the treatment group obtaining a greater proportion of the total 2 year recovery obtained in this early phase of the postoperative period in both clinical indexes. Additionally, statistically significant lower scores occurred in the CHARITÉ Artificial Disc group compared to the control fusion group at all postoperative time points, including the two year follow-up (p < 0.05). these results demonstrate superiority of disc arthroplasty over fusion in indicated patients using these two key clinica measures and a major improvement from baseline in both treatment groups. The control group scores closely followed the results of the BAK cage IDE study described by Kuslich et al in 1998(Kuslich, Ulstrom et al. 1998).

Critics of lumbar disc arthroplasty cite mixed short-term(Griffith, Shelokov et al. 1994; Cinotti, David et al. 1996; Zeegers, Bohnen et al. 1999; van Ooij, Oner et al. 2003) and long-term(Putzier, Funk et al. 2005) results, with the CHARITÉ Artificial Disc and review articles written prior to publication of the US trial(de Kleuver, Oner et al. 2003; Gamradt and Wang 2005) as the primary reason why disc arthroplasty is not a reasonable treatment for discogenic low back pain (Level IV Medical Evidence). Yet other more favorable long-term results in large patient cohorts are often only offhandedly considered(Lemaire, Skalli et al. 1997; David 2000; David 2004; Lemaire, Carrier et al. 2005)(Level IV Medical Evidence).

Disc arthroplasty with the CHARITÉ Artificial Disc has been performed outside the United States for over 20 years and as McAfee(McAfee 2005) eloquently points out, the overwhelming majority of the early disc arthroplasty cases were performed with widely variable indications, basic, rudimentary instrumentation, different sizing options, non-existent diagnostic testing, and a lack of fundamental understanding of lumbar spine biomechanics. These early issues and failures were well known to the clinical trial investigators at the time the FDA IDE study protocol was developed. In fact it was with this knowledge of the prior successes and failures that lead to the inclusion/exclusion criteria and surgical technique used in the FDA IDE study. Thus, the FDA IDE study was designed to provide Class I Medical Evidence on the efficacy and safety of treatment with lumbar disc arthroplasty that was learned from the earlier experience; to better define the appropriate patient selection, surgical technique and implant sizing. The prior artificial lumbar disc clinical information has been analyzed and clinical and surgical techniques have been refined through the 18 year history of the device. If this historical review of the prior series had not occurred, then the clinically superior results presented in this paper would not have been possible.

I would suggest that a "Coverage with Restrictions" recommendation be issued to verify that only the appropriate candidates receive the CHARITÉ Artificial Disc. This could be determined by requiring: 1) a DEXA scan to verify bone quality and eliminate osteopenic/osteoporosis patients; 2) Flexion/Extension radiographic with the standard radiographic of the lumbar spine (obliques, AP, lateral); and 3) a CT of the lumbar spine with contiguous fine cuts to assess the facets and pars bony anatomy in detail. By requiring adherence to the study inclusion/exclusion criteria, there are a decreasing number of patients over forty years of age that would qualify for the CHARITÉ Artificial Disc. In fact few patients were screened and admitted to the FDA IDE study in the 55 to 60 years age range. Thus, this recommendation could ensure that only the right patients are implanted with CHARITE without discriminating by age.

In conclusion, if the proposed CMS rule becomes final, patients will be denied an FDA-approved treatment with superior (Level I Medical Evidence) pain and level of disability outcomes; both directly with respect to indicated Medicare patients under the age of 65, and indirectly since many private payers base coverage decisions on CMS rulings.

Fred H. Geisler, MD, PhD
CHARITÉ™ FDA IDE Surgeon
Founder, Illinois Neuro-Spine Center at Rush-Copley Medical Center
2020 Ogden Ave, Suite 335
Aurora, IL 60504
Phone: (630) 236-4303
E-mail: fgeisler@concentric.net

REFERENCES

Blumenthal, S. L., P. C. McAfee, et al. (2005). "A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement with the CHARITÉ™ Artificial Disc Versus Lumbar Fusion Part I: Evaluation of Clinical Outcomes." Spine 30(14): 1565-75.
Cinotti, G., T. David, et al. (1996). "Results of disc prosthesis after a minimum follow-up period of 2 years." Spine 21(8): 995-1000. CMS "Proposed Decision Memo for Lumbar Artificial Disc Replacement (CAG-00292N), published February 15, 2005."
David, T. (2000). Lumbar Disc Prosthesis: Five Years Follow-up Study on 96 Patients. Presented at the 15th Annual Meeting of the North American Spine Society (NASS), New Orleans, Louisiana. David, T. (2004). "Lumbar Disc Prosthesis: An Analysis of Long-Term Complications for 272 CHARITÉ Artificial Disc Prostheses with Minimum 10 Year Follow-up." Spine J 4: S50-1.
de Kleuver, M., F. C. Oner, et al. (2003). "Total disc replacement for chronic low back pain: background and a systematic review of the literature." Eur Spine J 12(2): 108-16.
FDA (2004). "CHARITÉ Artificial Disc summary of safety and effectiveness. PMA number P040006. October 26, 2004."
Gamradt, S. C. and J. C. Wang (2005). "Lumbar disc arthroplasty." Spine J 5(1): 95-103.
Geisler, F. H., S. L. Blumenthal, et al. (2004). "Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charite intervertebral disc. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004." J Neurosurg Spine 1(2): 143-54.
Griffith, S. L., A. P. Shelokov, et al. (1994). "A multicenter retrospective study of the clinical results of the LINK SB Charite intervertebral prosthesis. The initial European experience." Spine 19(16): 1842-9.
Hagg, O., P. Fritzell, et al. (2003). "Predictors of outcome in fusion surgery for chronic low back pain. A report from the Swedish Lumbar Spine Study." Eur Spine J 12(1): 22-33.
Kuslich, S. D., C. L. Ulstrom, et al. (1998). "The Bagby and Kuslich method of lumbar interbody fusion. History, techniques, and 2-year follow-up results of a United States prospective, multicenter trial." Spine 23(11): 1267-78; discussion 1279.
Lemaire, J. P., H. Carrier, et al. (2005). "Clinical and Radiological Outcomes With the CHARITÉ™ Artificial Disc: A 10-Year Minimum Follow-Up." J Spinal Disord 18(4): 353-59.
Lemaire, J. P., W. Skalli, et al. (1997). "Intervertebral disc prosthesis. Results and prospects for the year 2000." Clin Orthop(337): 64-76.
McAfee, P. C. (2005). "Comments on the van Ooij article." J Spinal Disord Tech 18(1): 116-7.
McAfee, P. C., B. Cunningham, et al. (2005). "A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement with the CHARITÉ™ Artificial Disc Versus Lumbar Fusion Part II: Evaluation of Radiographic Outcomes and Correlation of Surgical Technique Accuracy with Clinical Outcomes." Spine 30(14): 1576-83.
Putzier, M., J. F. Funk, et al. (2005). "Charité total disc replacement—clinical and radiographical results after an average follow-up of 17 years." Eur Spine J: published online October 28, 2005. Register, F. (2004). Panel Transcript: Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee.
van Ooij, A., F. C. Oner, et al. (2003). "Complications of artificial disc replacement: a report of 27 patients with the SB Charite disc." J Spinal Disord Tech 16(4): 369-83.
Zeegers, W. S., L. M. Bohnen, et al. (1999). "Artificial disc replacement with the modular type SB Charite III: 2-year results in 50 prospectively studied patients." Eur Spine J 8(3): 210-7.

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I am a fellowship trained orthopedic spine surgeon, board certified by the American Board of Orthopedic Surgery.

I am in private practice in Gillette, Wyoming. I have been in practice for approximately 8 years and my practice is limited to surgery of the spine.

To date, I have implanted 9 Charite lumbar disc replacements. I wish to speak in support of a favorable decision to approve coverage for lumbar disc replacement.

The argument has been made that very few Medicare patients will be candidates for the artificial lumbar disc. It is true that most Medicare patients are elderly and for several reasons will not be candidates for this technology. However, this does not apply to all Medicare patients. There are at least 6 million disabled Americans under the age of 65 who may be candidates for this technology. They should not be deprived of this potentially pain relieving and function restoring device just because the majority of Medicare patients may not be candidates.

There have been assertions made that the indications are not clear. This is entirely false. The results of the Level 1 data generated by the IDE study, and accepted by the FDA, give us very clear and carefully defined indications. These indications are very well defined and all surgeons trained to implant these devices are carefully and thoroughly trained in the indications and contraindications. In follow up scientific meetings of spine surgeons, the message is constantly hammered home that the indications must be followed carefully.

These carefully defined and thoroughly taught indications and contraindications rule out most Medicare patients. Surgeons thus trained, will not, in general, use this device inappropriately in the Medicare population. On the other hand, these same surgeons should have this option for those minority members of the Medicare population who do meet the strict criteria.

The issue has been raised of the risks of anterior spinal surgery. This is a deliberately misleading argument. I am dismayed that people writing on behalf of an agency of the United States government would take such a partisan stance and deliberately mislead policy makers. The fact is, anterior spinal surgery has been a common procedure used for spinal fusions for many years. This anterior surgical approach to the lumbar spine is the same approach used for lumbar disc replacement. Thousands of spine surgeons and their general and vascular surgical colleagues are intimately familiar and very experienced with these anterior procedures. I myself have performed several hundred anterior spinal surgeries before I ever performed a lumbar disc replacement. In fact, the FDA and corporate rules for training surgeons for lumbar disc replacement require that surgeons must already be experienced in anterior spinal surgery before implanting these devices. The objective truth of the matter is, that the risks of this procedure are much less than other new surgical procedures PRECISELY because the surgeons doing it are already experienced in anterior spinal surgery.

Another dismaying and deliberately misleading objection raised was that anterior revision surgery is very risky. This statement deliberately ignored and concealed two very important pieces of data. Firstly, the FDA guidelines and corporate training states clearly that for the most common forms of implant failure, which in fact are rare, the remedy is POSTERIOR fusion, NOT an anterior revision. Secondly, the large published series of European and Australian revisons show that anterior revisions can and are safely performed by experienced surgeons with few or no complications.

My next point is another that falls in the category of supposed experts giving biased and partisan opinion to a policy making agency of the United States government. The studies cited in the CMS memorandum recommending non coverage, were summarized in a biased and incomplete manner. Firstly, the memorandum citing the Griffith paper deliberately concealed from policy makers the the series included data from all three prototypes of the Charite disc, SB I, II and III, and also concealed that fact the the paper included prototypes and construction materials that were not released for use beyond research applications.

The memorandum further concealed critical facts from policy makers by not disclosing that the Zeegers paper reported results from the 1990's when the indications now established by the FDA were neither available nor followed. Thus the patient outcomes reported in the Zeegers paper cannot be honestly, accurately nor ethically compared to the results of the FDA approved IDE study here in the USA. Further deliberate obfuscation of the facts were indulged in by the authors of the memorandum in their recitation of the paper by Cinotti and Caspi. Like the Zeegers paper, the patient outcomes reported in this study were from an era when the strict and carefully taught indications established by the FDA were not available. Further, the FDA approved IDE study here in the USA established the need for using the correct size implant and placing it accurately. The device and surgical technique as it exists today gives surgeons several more sizes of implant to provide an ideal implant choice for individual patients. These implant sizes were not available when the above mentioned studies were done. In addition, the current technique uses highly developed instrumentation to assure accurate implant placement. At the time of the above mentioned papers, this instrumentation was not available. The memorandum concealed this fact from policy makers.

Similar objections can be made to the references cited in the memorandum for the papers by de Kleuver and the paper by Putzier. They were outdated by the time the FDA approved, rigorous and carefully controlled IDE study was underway. Of particular concern is that the authors of the memorandum may have cited inaccurate evidence reported by Putzier et al. Dr. Karin Buttner-Janz, the highly respected inventor of the Charite disc and a gold medal winning Olympic athlete, disputes the accuracy of this paper's reported data from the Charite hospital where she did her ground breaking work.

In all these cases, the silent fact is that all these authors report on patients whose surgeons were not trained in lumbar disc replacement to the level of today's surgeons, the surgeons did not have the implant designs and choices available today, nor did they have the intrumentation of today to ensure accurate placement of the implant.

The FDA IDE study represents a rare and infinitely valuable piece of scientific endeavor. It represents true Class I data, a very rare assest in today's medicolegal climate. To ignore, denigrate and misrepresent these data, causes irreparable harm to the policy makers and the American public.

My last point is that it is well know that the decision of the CMS will be used by private third party payers across the United States to approve or deny this technology to ordinary Americans across the span of this country, regardless of the fact that most Americans with private health insurance are demographically very different from the Medicare population. Thus, a negative coverage decision by CMS, based on faulty and misleading information, will have little impact on the majority of Americans for whose care they are responsible. It will, however, have an unfair and unfortunate effect on the millions of Americans with private insurance whose lives may be postively impacted by this new and promising technology.

Thank you.
Nathan S. Simpson, M.D.

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I cannot comprehend how CMS can make a decision regarding ADR technology, specifically the Charite without: (1) providing a public disclosure of its “relationship” with Dr. Deyo and detailing why CMS invited him to write the request for a national ban on ADR, (2) acknowledge the downfalls of each and all fusion approaches and instrumentation/devices and then acknowledge the fact that ADR was developed to try and solve these fusion problems, and/or (3) why CMS hasn’t demanded a full review and analysis of various fusion techniques BEFORE attempting to make full and fair comparison to ADR, let alone crippling such a huge medical advance in DDD by banning ADR when it has had such a documented long-term success rate in Europe!

CMS cannot possibly make a fair and ethical decision regarding the future of ADR without a much-needed comprehensive published review of existing fusion techniques, their failure rates, revision surgery rates, and incidences of adjacent level second and third surgeries. In this comment, I will be citing a number of relevant published medical studies regarding fusion approaches, instrumentation, and devices which discuss the downfalls and failures of fusion. I respectfully demand these publications be fully read, evaluated, and considered before making a formal decision against ADR.

I. Who exactly is Dr. Deyo, and why did CMS invite him to write a letter requesting a national ban on ADR?

The public needs to know who is providing supplemental income to Dr. Deyo? Has CMS ever paid Dr. Deyo for any of his research and/or opinions? Is Dr. Deyo funded at all by any insurance companies? If CMS does not have these answers, it should investigate Dr. Deyo’s background and funding and publicly and fully disclose this information before it can ethically cite to him as the instigator of this request for a national ban on ADR! Especially since he has zero surgical training or experience.

I’d like to identify an interview given by Dr. Deyo regarding his request for a national ban on ADR. In an interview by Orthopaedics This Week, Dr. Deyo made some revealing comments that cannot be ignored. See CMS, the FDA, a Professor and Civics Lessons, By Walter Eisner, Orthopaedics This Week, Vol. 2: Issue 8, this interview is also referenced at http://www.adrsupport.org/private-cgi-bin/ultimatebb.cgi?ubb=get_topic;f=3;t=000734#000005.

Dr. Deyo was asked: “Did CMS contact you and ask you to comment on this?”

Dr. Deyo replied: “No, actually I had concerns about this and had spoken in off-hand conversations with people at CMS and they said, well, would you be willing to write a letter and I said sure.” Id.

If CMS is asking Dr. Deyo whether he would be willing to write a letter, then CMS is in fact asking Dr. Deyo to comment! Let’s call a spade a spade!

Dr. Deyo was also asked: “… [I]t almost looks like [CMS was] waiting for somebody to give them an opportunity to comment on this. Where is all this going to go? How are the FDA and CMS going to learn to play nice together?

Dr. Deyo replied: “I don’t think they are opposed to each other in any way. I think CMS would say the FDA just doesn’t go far enough in their evaluation of new drugs or devices. I actually think the FDA should set a higher bar, especially for implantable devices. Obviously I don’t want to see a requirement for randomized trials for rubber gloves and contact lenses every time one of those comes along, but when it comes to surgical implants I think it might be reasonable to require randomized trials routinely. In this case they were required, but of course for most spinal implants, especially those for fusion, no randomized trials were ever required and that’s one of the missing links in the evidence chain here also. Again, we’ve compared the new technology to an old technology that itself was never subject to clinical trials. Id.

This last quote from the interview raises a very important concern! If fusion was not subject to the rigors of randomized clinical trials as ADR, then how can CMS say that fusion is the gold standard, and is proven safe and effective?

Even in one of Dr. Deyo’s co-authored articles, the article implies that the skyrocketing increase in lumbar fusion surgeries for DDD after 1996 was attributed to the introduction and marketing of fusion cages rather than any empirical evidence to prove the safety and efficacy of these new devices in the long-term. SEE United States trends in lumbar fusion surgery for degenerative conditions. PMID: 15959375. Spine. 2005 Jun 15;30(12):1441-5; discussion 1446-7. Deyo RA, Gray DT, Kreuter W, Mirza S, Martin BI. Department of Medicine, University of Washington, Seattle, Washington, USA. deyo@u.washington.edu (A Retrospective cohort study Healthcare Cost and Utilization Project Nationwide Inpatient Sample data from 1988 through 2001 to examine trends to determine if lumbar fusion rates increased in the 1990s. It found that in 2001, over 122,000 lumbar fusions were performed nationwide for degenerative conditions, which represented a 220% increase from 1990 in fusions per 100,000. The increase accelerated after 1996, when fusion cages were approved. From 1996 to 2001, the number of lumbar fusions increased 113%, compared with 13 to 15% for hip replacement and knee arthroplasty. Rates of lumbar fusion rose most rapidly among patients aged 60 and above. It concluded that these increases were not associated with reports of clarified indications or improved efficacy, suggesting a need for better data on the efficacy of various fusion techniques for various indications.)

SEE also: Trends and Variations in the Use of Spine Surgery. PMID: 16462438. Clin Orthop Relat Res. 2006 Feb;443:139-146. Deyo RA, Mirza SK. From the Department of Medicine, the Department of Health Services, the Department of Orthopaedics and Sports Medicine, and the section Center for Cost and Outcomes Research, University of Washington, Seattle, WA. Examining trends and geographic variations in clinical care offers insights into changes in clinical decision-making. We summarized data on spine surgical rates, trends, and variations in the United States to highlight areas of professional uncertainty and questions for future research. The United States has the highest rate of spine surgery in the world, but spine surgery shows wider geographic variations than most other procedures. For example, Medicare data for 2001 showed six fold variations in spine surgery rates among United States cities, and 10-fold variations in spine fusion rates. United States spine surgery rates rose 55% in the 1980s. In the 1990s, studies of surgical rates became more difficult because 20% of discectomies shifted to an outpatient setting. Extrapolations from states with ambulatory surgery data suggest overall lumbar surgery rates continued to rise throughout the 1990s. The most rapid increase was for spinal fusion, which tripled during the 1990s and accounted for an increasing proportion of all spine procedures. Some increases coincided with the introduction of new surgical implants. Despite new technologies, rates of repeat surgery after fusion were no lower than the rates after decompression alone. As new technology for spine surgery is introduced at an accelerating pace, we anticipate substantial changes in surgery patterns. Analysis of population-based data may be useful for surveillance of changes and their impacts.

These studies make one wonder whether Dr. Deyo and CMS are just afraid of an increase of demand (i.e.: costs) for spine surgery because of this new ADR technology. Well, why is that necessarily a problem? Dr. Deyo, CMS and insurance companies complain there is no long-term data to PROVE the long-term efficacy of motion preserving technology. They imply this is only a theoretical and unproven technology. But I ask, where is the long-term data to PROVE fusion really solving our back problems? And which fusion approach is the best for DDD and/or trauma induced internal disc disruption problems?

How can CMS possibly say that ADR is not substantially more safe and effective when ADR has been subjected to stronger tests and standards? If you’re going to compare ADR to fusion than get the fusion data together before criticizing the more rigorously tested ADR data! As a layperson, I am submitting some published medical studies regarding various fusion techniques. I invite CMS as well as other surgeons to find, identify and submit more data so that CMS may make a more informed decision comparing ADR to fusion.

II. Shouldn’t we be comparing the cost of 1 ADR to every 2 fusion surgeries since it seems inevitable that the majority of primary fusion patients will need a revision surgery or a second and possibly even third adjacent level fusion surgery due to the failure or stress on the spine from the primary fusion surgery?

In the previously mentioned interview with Dr. Deyo, he was asked about CMS’ preliminary report…“CMS in its preliminary report didn’t touch on the issue of cost and limited resources.”

Dr. Deyo replied: “They’re not allowed to. That’s not supposed to be part of their consideration. Though I think they are focused appropriately on efficacy and safety. But, let’s be realistic. If these devices were priced at $1.50 they probably wouldn’t be subject to the same level of scrutiny. But if they’re at $15,000 the level of scrutiny goes up. I suspect that’s true for any purchaser of any product, anywhere. The higher the cost, the more carefully you look at it.”

**** “FDA approval is no longer going to allow companies to market at will. It means that the evidence bar has been raised and is being raised by insurance carriers. It’s not going to be enough to say that this more expensive new product is at least as good. People are going to say if it’s more expensive, prove to me it’s better.”

Dr. Deyo raises an interesting point about whether financial concerns are in fact the underlying reason why CMS wants to ban ADR coverage, and if it were proven cheaper than fusion, would they be more willing to cover it?

Well I have a couple of arguments to make on the “cost/benefit” side of things. It is inaccurate and should be improper to compare the cost of one fusion surgery to one ADR surgery. The costs of these surgeries should include the costs of revision surgeries due to failure rates as well as secondary and third surgeries due to adjacent level instability created by the stress from a primary fusion surgery.

For example, in at least one published study, the incidence rate for a second fusion surgery due to adjacent level instability increased over time. At 2.4 years after a primary lumbar fusion surgery, 7% of the patients required another fusion at an adjacent level. By 33 years after a primary fusion, 45% required another fusion at an adjacent level. The average interval between surgeries was 5.2 years and 12.8 % had to undergo a 3rd lumbar fusion surgery at an adjacent level. See Surgical treatment of adjacent instability after lumbar spine fusion. PMID: 11707723, Spine. 2001 Nov 15;26(22):E519-24, Chen WJ, Lai PL, Niu CC, Chen LH, Fu TS, Wong CB.Department of Orthopaedic Surgery, Chang Gung Memorial Hospital, Taoyuan, Taiwan. chenwenj@adm.cgmh.org.tw Chen WJ, Lai PL, (a retrospective review of 39 patients who underwent a secondary spine fusion surgery for lumbar adjacent instability.)

These figures are significant for those of us patients in our 20’s and 30’s disabled by back pain who demand ADR. We do not want continuing levels of fusion surgery throughout the rest of our lives, likely creating a “flat back” problem. We want to preserve as much motion as possible to alleviate any unnecessary stress from fusion on adjacent spine segments, thereby avoiding future expensive and painful surgeries. Throughout published medical articles discussing various fusion approaches, a common complaint is that either the surgery failed due to non-union, adjacent level instability, and/or recurrent pain symptoms due to instrumentation or migration of fusion devices. Failed back syndrome after lumbar fusion surgery in not something CMS can gloss over.

In the conclusion of at least one published study it states, “Despite extensive work in recent years, FBS (failed back syndrome) remains a challenging and costly disorder.” SEE: Failed back syndrome. PMID: 15335443, Neurologist. 2004 Sep;10(5):259-64, Onesti ST. Department of Neurosurgery, SUNY Downstate Medical Center, Brooklyn, New York 11203, USA. Stephen.Onesti@downstate.edu. Failed back syndrome (FBS) is a well-recognized complication of surgery of the lumbar spine. It can result in chronic pain and disability, often with disastrous emotional and financial consequences to the patient. Many patients have traditionally been classified as "spinal cripples" and are consigned to a life of long-term narcotic treatment with little chance of recovery. Recent progress in our understanding of this complex condition, as well as advances in surgical and medical treatment, have offered hope for improved outcomes and quality of life for these patients.
REVIEW SUMMARY: This study explores the complex and multifactorial etiology of FBS, including reasons for surgical failure, indications for surgical revision, and adjunctive treatments such as pain management procedures.

SEE also: Failed degenerative lumbar spine surgery. PMID: 12914270, Orthop Clin North Am. 2003 Apr;34(2):309-24, Diwan AD, Parvartaneni H, Cammisa F. University of New South Wales, Saint George Hospital Campus, Department of Orthopaedic Surgery, Level 2, 4-10 South Street, Sydney 2217, Australia. a.diwan@unsw.edu.au. Significant back and leg symptoms develop in approximately …15%-20% of patients who have had a spinal fusion procedure for degenerative disease of the lumbar spine during the ensuing 3-5 year so that they require revision lumbar surgery. The process of evaluation and surgical management for failed lumbar degeneration is a science and an art that requires a great deal of understanding and commitment on the part of the surgeon. The temporal trend of improving outcomes is aided in part by emerging technologies, however, one has to be constantly aware of simple factors that influence outcome. The use of published literature and experiences of peers helps one offer appropriate surgical intervention while improving the long-term results of revision surgery of the lumbar spine.

SEE also: Adjacent instability after instrumented lumbar fusion. PMID: 14765748, Chang Gung Med J. 2003 Nov;26(11):792-8, Chen WJ, Lai PL, Chen LH. Department of Orthopedic Surgery, Chang Gung Memorial Hospital, Taipei. chenwenj@cgmh.org.tw\ The invention of pedicle screw instrumentation has greatly improved outcomes of spinal fusion, which has become the treatment of choice for lumbar spondylolisthesis. As researchers accumulate experience, both theoretical and clinical advances are continually being reported. A review of the literature and the experience of the authors show that the development of adjacent instability, as in the breakdown of a neighboring unfixed motion segment, is a common consequence of an instrumented lumbar spine. This article reviews the risk factors and surgical treatment of adjacent instability. The authors believe that proper preoperative planning and complete surgical procedures are imperative to prevent adjacent instability. For those who need revision surgery, meticulous surgical techniques can achieve satisfactory results.

If CMS is not permitted to look at the costs of ADR in making this decision, it must prove that it is not looking at costs. In the alternative, if cost is a legitimate factor, then let’s make a proper cost comparison of fusion to ADR surgery.

III. Risks associated with ADR no worse than fusion.

CMS/Dr. Deyo’s argument that there is no revision strategy for Charite or other ADR products is invalid argument to justify a ban on ADR. Similarly, their argument that the anterior approach for ADR is not safe, because major veins must be moved out of the way to access lower lumbar segments, is also an invalid argument. The reason why these are invalid arguments to support a ban on ADR is because the anterior approach for fusion (AILF) has the same risks as ADR and the revision strategy for both can be the same.

It is my understanding that AILF is the preferred approach to fusion since the disk space is better accessed from the front, and surgeons can avoid cutting through major muscles. My understanding of the major problem with a posterior approach to fusion (PILF) is that major muscles and major nerves must be moved. Furthermore, if an AILF fails, the revision strategy can be a PILF or combination of fusion approaches.

In published study comparing different fusion approaches, it acknowledged that while a posterior approach historically was more common, the current trend is to use an anterior approach, but nevertheless, the superiority of these approaches varies in the scientific literature. This study also goes on to state that some of the advantages to an anterior approach to lumbar spine fusion are that you can avoid damage to the posterior supporting muscles and ligaments, as well as damage to the spinal cord and nerve roots. See, Single-level lumbar spine fusion: a comparison of anterior and posterior approaches. PMID: 12394658, J Spinal Disord Tech. 2002 Oct;15(5):355-61. Pradhan BB, Nassar JA, Delamarter RB, Wang JC. Department of Orthopaedic Surgery, UCLA School of Medicine, Los Angeles 90095-6902, USA. (A retrospective review of 122 patients who underwent single-level lumbar spine fusion to compare perioperative morbidity and early results of single-level anterior interbody posterolateral intertransverse process lumbar spine fusion and to provide objective findings that may be useful in selecting surgical method. There was significantly less blood loss, need for transfusion, amount of blood transfused, operative time, and hospital stay for patients with anterior fusion procedures (p < 0.01). Clinical results were significantly worse for those undergoing revision primary fusion (p < 0.01). The anterior approach to single-level lumbar fusion is associated with less morbidity than the posterolateral approach. This may in turn affect surgical outcome and hospital cost. However, both approaches to single-level lumbar fusion produce similar early fusion rates and clinical results. Revision fusions had poor early results regardless of approach.

The revision strategies for failed union or adjacent level instability can require many of the same approaches as a primary fusion. The revision problems for ADR due to scar tissue are the same as revision surgeries after a primary fusion surgery. Revision surgeries after either an AILF or PILF have increased risks due to scarring and other issues.

SEE: Revision strategies for lumbar pseudarthrosis. PMID: 15347227, Neurosurg Focus. 2003 Sep 15;15(3):E9, Ondra SL, Marzouk S. Department o f Neurosurgery, Northwestern University, Chicago, Illinois 60611, USA. songra@nmff.org. Management and avoidance of lumbar pseudarthrosis are among the most common and challenging tasks faced by reconstructive spine surgeons. The risks of pseudarthrosis can be broadly divided into two categories: those within a surgeon's control and those not within his/her control. These include biological factors, graft choices, site preparation, and surgical design. The authors review the biological factors that affect fusion and how they can be manipulated to avoid or manage lumbar pseudarthrosis. Surgical planning and construct design to prevent or treat pseudarthrosis will also be discussed. Additionally, the importance of restoring sagittal balance will be reviewed.

SEE also: Revision of failed lumbar fusions. A comparison of anterior autograft and allograft. PMID: 9431609, Spine. 1997 Dec 1;22(23):2748-55. Buttermann GR, Glazer PA, Hu SS, Bradford DS. Department of Orthopaedic Surgery, University of California-San Francisco, California. The radiographic and clinical results of two different anterior structural grafts were compared in 38 patients who had combined anterior-posterior revision surgery for failed lumbar fusion.
OBJECTIVES: Failed lumbar fusion surgery, such as pseudarthrosis or flatback deformity, may result in disabling pain. The optimum revision technique has yet to be defined. The authors of the current study sought to determine which of two different types of anterior graft yields the best results.
SUMMARY OF BACKGROUND DATA: Posterior procedures for revision of a failed lumbar fusion have not yielded reliably successful results. A combined anterior-posterior approach may be effective in restoring sagittal balance and enhancing fusion rates. Recent studies have shown femoral ring allografts to be effective in lumbar fusion revision, but no studies have compared these with other types of structural grafts.
METHODS: Thirty-eight patients with pseudarthrosis were treated with combined anterior-posterior lumbar spine fusion using either femoral ring allografts (26 patients) or tricortical iliac autografts (12 patients). Radiographic follow-up examination and retrospective patient self-assessment questionnaires were used to evaluate outcomes. Results were assessed by independent reviewers after a mean follow-up period of 35 months.
RESULTS: Radiographic follow-up examination revealed acceptably low pseudarthrosis rates for structural autografts (0%) and allografts (6%). The questionnaires revealed significant improvement in pain for both groups. Allograft patients showed greater improvement in function, less pain medication usage, and higher overall success rates (83%) than autograft patients (64%).
CONCLUSIONS: Femoral ring allografts are as effective, clinically and radiographically, as tricortical iliac autografts when used as an anterior structural element in revision lumbar spine fusion in patients who have undergone multiple surgical procedures for pseudarthrosis or flatback deformity. The slightly greater improvement for the allograft group needs to be confirmed in a larger study.

SEE also: Revision strategies for lumbar pseudarthrosis. PMID: 12389284, Orthop Clin North Am. 2002 Apr;33(2):381-92., Etminan M, Girardi FP, Khan SN, Cammisa FP Jr. Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021, USA.This study reveals that revision surgery for pseudarthrosis remains costly and complicated. Local and systemic factors should be corrected or improved before further surgery is performed. Careful evaluation is mandatory, and patients' expectations should be addressed fully by the surgeon before undertaking any surgical procedure. The single most important factor in achieving a successful clinical outcome in revision spine surgery is patient selection. Pseudarthrosis is still one of the most difficult conditions to assess as a source of symptoms, and not surprisingly the outcome from repair of pseudarthrosis is the most difficult to predict. Posterior procedures for revision of a failed lumbar fusion have not yielded reliably successful results; however, this approach does have a significant role in the appropriately selected candidate. A combined anteroposterior approach may be more effective in restoring sagittal balance and enhancing fusion rates. The use of posterior instrumentation in light of an anterior pseudarthrosis or anterior support in light of a posterior pseudarthrosis is a viable option for treatment in these circumstances. Several osteoinductive growth factors, referred to as bone morphogenetic proteins, have been shown to induce transformation of undifferentiated mesenchymal cells into chondroblasts and osteoblasts, which results in the formation of de novo bone. Numerous animal studies have demonstrated the superiority of bone morphogenetic proteins over autogenous bone grafts in various orthopedic settings. Bone morphogenetic protein (by itself or in conjunction with autogenous bone) has been shown repeatedly to produce a better quality of spine fusion in a decreased interval of time when compared with the use of autogenous bone alone. These materials, however, remain investigational and currently are not widely used. Prevention of pseudarthrosis is the most successful treatment, although this is not always possible. Appropriate patient selection, surgical techniques, and the use of biologic implants and gene therapy in the near future will make spinal fusion a more predictable procedure to perform. Undoubtedly there is great difficulty in performing satisfactory and statistically verifiable conclusions from the available published studies. Better prospective outcomes studies are needed to improve our knowledge regarding overall patient satisfaction, function, residual pain, and health impact of the treatment of lumbar spine pseudarthrosis.

SEE also: Functional outcome after posterolateral spinal fusion using pedicle screws: comparison between primary and salvage procedure. PMID: 9765041, Eur Spine J. 1998;7(4):321-7. Christensen FB, Thomsen K, Eiskjaer SP, Gelinick J, Bunger CE. Biomechanics Laboratory, Aarhus University Hospital, Denmark. It states that while lumbar spinal fusion is a commonly performed surgical procedure, both the indications for its performance and its results remain controversial. It is generally believed that apart from situations where obvious measurable instability exists, a repeat surgical procedure such as spinal fusion does not improve the functional outcome in more than an average of 50% of cases. The study was designed as a prospective case/referent study with a 2-year follow-up. A total of 39 patients underwent a short posterior fusion with Cotrel-Dubousset (CD) pedicle screw fixation after earlier surgery of the lumbar spine. Two patients were erroneously omitted from the study at the index, so 37 patients were included in the salvage group. In the same period, 69 patients underwent lumbar fusion with pedicle screw fixation (CD) as primary surgery (referent group). Functional outcome was assessed by means of the Dallas Pain Questionnaire preoperatively and 1 and 2 years postoperatively. Fusion rates were determined by ordinary X-ray evaluation by two independent observers. Patients who had undergone previous spinal surgery had a significant improvement in functional outcome in terms of daily activity, work and leisure-time activities and anxiety/depression. With regard to social functioning, a significantly inferior outcome was found after the salvage procedure. The return-to-work rates at 2 years after surgery were 50% in the salvage group and 53% in the referent group. There was a significant correlation between radiological evaluation of the fusion mass and the functional outcome. The fusion rate was 76% in the salvage group and 72% in the referent group. This study demonstrates that a posterolateral spinal fusion can be effectively used as a salvage procedure. The functional and radiological outcome of the patients with revision surgery did not differ from those of the group of patients who underwent primary surgery. There was, however a clear indication of inferior social functioning after revision surgery.
SEE also: Management of symptomatic lumbar pseudarthrosis with anteroposterior fusion. A functional and radiographic outcome study, PMID: 10647170, Spine. 2000 Jan;25(1):123-9; discussion 130, Albert TJ, Pinto M, Denis F. Rothman Institute, Philadelphia, Pennsylvania, USA. This was an independent retrospective review of 37 patients undergoing 39 anteroposterior lumbar fusions for lumbar pseudarthrosis repair between 1984 and 1990. Most reported techniques of pseudarthrosis repair involve posterior fusion with no instrumentation, posterior fusion with instrumentation, or anterior fusion alone. The results of lumbar pseudarthrosis repair are poor. Fusion rates range from 30% to 70%, with only a 30% to 50% rate of functional success. Pseudarthrosis was defined when one or more levels were involved and when it occurred anteriorly and posteriorly. In 12 patients (35%), the outcome was rated as functional failure.

SEE also: Patient satisfaction after circumferential lumbar fusion. PMID: 10752105, Spine. 2000 Mar 15;25(6):722-6, Slosar PJ, Reynolds JB, Schofferman J, Goldthwaite N, White AH, Keaney D. SpineCare Medical Group, San Francisco Spine Institute, Daly City, California, USA. pslosar4@ix.netcom.com. A review of 141 consecutive patients who underwent instrumented circumferential lumbar fusions, minimum follow-up of 2 years.
OBJECTIVES: To evaluate clinical outcomes and assess patient satisfaction with circumferential lumbar fusions.
SUMMARY OF BACKGROUND DATA: Circumferential lumbar fusion has been used as a salvage procedure for revision spine surgery.
RESULTS: There were follow-up data in 133 of the 141 patients (92%). Mean duration of follow-up was 37.2 months. There were 41 (31%) primary and 92 (69%) revision surgeries. There were 73 (55%) workers' compensation and 60 (45%) non-workers' compensation patients. There were radiographs available at 12-month follow-up in 86 patients (65%). There was solid radiographic fusion in 85 (99%) of the 86 patients. The overall complication rate was 20%. Clinical outcome was determined by the patient satisfaction questionnaire. There were 14 (11%) who chose the statement, "surgery met my expectations"; 68 (51%) who chose, "surgery improved my condition enough that I would go through it again for the same outcome"; 26 (20%) who chose, "surgery helped me but I would not go through it again for the same outcome"; and 25 (19%) who chose, "I am the same or worse compared with before surgery." There was no statistical difference in patient satisfaction between primary and revision surgeries or between workers' compensation versus non-workers' compensation groups.
CONCLUSIONS: Circumferential lumbar fusion is a useful procedure for a patient with difficult reconstructive disease. There is a very high fusion rate. Overall, 62% of patients are satisfied with the result, especially those with a diagnosis of pseudarthrosis or spondylolisthesis with stenosis. Patients who are working before surgery and patients who are not injured workers also tended to progress well.

As we all know, the Charite is still the only FDA approved ADR device. There is a promising published study discussing the success of a revision Charite surgery. SEE: Revision of a Charite artificial disc 9.5 years in vivo to a new Charite artificial disc: case report and explant analysis. PMID: 15672241, Eur Spine J. 2005 Jun;14(5):507-11. Epub 2005 Jan 26, David T. Polyclinique de Bois-Bernard, Route De Neuvireuil Bois/Benard, 62320 Bois-Bernard, France. t.david@voila.fr. This report describes a case of one-level total disc replacement (TDR) of L5-S1 requiring revision at 9.5 years following the index surgery due to polyethylene failure caused by high oxidation. Primary revision strategies for TDR include instrumented posterolateral fusion, or 360 degrees fusion with replacement of the prosthesis with cages or allograft bone. A revision of a TDR with a similar prosthesis has not been described in the literature. An active 42-year-old female underwent TDR with a Charite artificial disc. She remained active and pain free for 9.5 years before presenting with moderate low-back pain and sciatica. Radiographic studies confirmed a fragmented polyethylene core. The failed prosthesis was revised to a new Charite disc with the patient again active and pain free for 6 months following surgery. Chemical and physical analysis of the core indicated high oxidation due to gamma sterilization in air; a process changed to gamma sterilization in nitrogen in 1998 to meet industry standards. No evidence of wear debris was noted. Revision of an artificial disc with an artificial disc can be performed safely and adequately with the Charite disc prosthesis as an alternative to fusion necessitated by a device failure. An anterior revision approach carries significant risk and should only be performed by surgeons experienced in anterior lumbar surgery.

IV. How can CMS be allowed to discredit and ignore the FDA’s findings that Charite has been proven safe and effective?

The FDA (not CMS) is the government agency appointed to test, evaluate, and determine the safety and efficacy of new medical devices. If you are lucky enough to be a federal employee, the federal government is forcing private insurance companies to cover Charite devices. Why can’t all citizens benefit from the FDA’s findings??? CMS is a federal agency providing federal funds for healthcare, therefore CMS should not be allowed to ignore or disagree with the FDA’s decision. Only one agency should be appointed with the authority to make safety and efficacy decisions! CMS must be forced to follow and accept the FDA’s decision and cover this procedure for Medicare patients who meet the criteria for use of this device. There are plenty of contraindications, so if most of the Medicare elderly population falls into one or more of the contraindication categories, then just those patients should not receive the device. What’s the big deal here? Why do you NEED to implement a national ban? Isn’t there a pre-authorization process for all fusion and/or ADR surgeries? Why not just flag those that fall into the contraindication categories and deny coverage based on certain contraindications?Furthermore, how can CMS disregard the hundreds of surgeons with hands-on experience implanting ADR, who have submitted public comments in support of ADR. How can CMS discount the years of European data showing the success of Charite claiming they have not gone though the rigorous US clinical trial standard, yet accept and cover fusion techniques as the “gold standard” when fusion techniques have also not undergone current rigorous US clinical trial standards and studies show fusion is still a problematic and costly surgical option?

And yet, somehow, CMS seems content to grossly favor the opinion of Dr. Deyo who is not a surgeon, and who is biased and pre-disposed to discourage surgery claims, and encourage non-surgical treatment. Ironically, ADR is not recommended until a patient has attempted and exhausted all non-surgical options! I’ve been a pin cushion to pain management injections, I have esophagus problems due to years of pain medications, and every year for the past 3 years I have exhausted my insurance benefits for physical therapy treatments. I need surgery and I am too young to be forced to have fusion instead of ADR.

V. It is grossly unethical for CMS, a government agency, to ignore the impact its decision will have on private insurance companies and whether these insurance companies will cover ADR surgery for their insureds.

CMS must be aware of the fact that private insurance companies look to CMS for guidance in whether to cover new medical procedures. In my own denial letter from my insurance company, it cited to CMS’ failure to support ADR as justification to deny coverage to me. This awareness must affect CMS’ decision-making process. CMS should not ban a new device that can help hundreds of thousands of private insureds, especially since CMS could implement other control methods to deny coverage to it’s own Medicare population. CMS can publish the same contraindications provided by the manufacturer and limit a ban on ADR to people who fall within those contraindications.

CMS’ proposed ban is also outrageous because CMS uses private insurance companies to administer health care plans to a large part of the Medicare population. There is a very real financial & medical coverage relationship between CMS and private insurance companies. Both CMS and private insurance companies have a bias against covering new technology that will benefit a new part of the population to whom fusion was not recommended, because it will in turn, increase the number of surgery claims. The federal government must not let CMS to be influenced by private insurance company monies and contracts to institute a national ban on ADR.

In conclusion, I am still dumbfounded how this data collecting MD, (Dr. Deyo) with no hands-on orthopedic surgical experience, let alone zero experience implanting ADRs, can assist CMS in justifying a ban on this technology. If CMS is going to ask an MD to help give it a reason to ban ADR, can it at least pick a surgeon who has implanted ADRs. That would give CMS a little more credibility!

There are other ways to control costs. If CMS agrees to cover ADR but only pay “X” amount for the disk…put the burden on manufacturers to lower its costs. If CMS wants to make sure that certain Medicare patients with contraindications for ADR do not receive ADR than make that your policy. There is no need for a national ban for everyone. A National ban only hurts those that would otherwise qualify and benefit from this new FDA approved technology.

Less

CMS should consider

The disabled population who may benefit http://www.cms.hhs.gov/MedicareEnRpts/Downloads/HI-SMI.pdf§ Number of people currently enrolled in the Medicare program – 41,086,981

The elderly population

Refute the evidence that was used in the evaluation

Case series cited in the CMS memorandum include Griffith et al (1994), Cinotti et al (1996), Zeegers (1999), and Caspi (2003).

A review paper by de Kleuver et al is cited. This literature review was performed in 2002 and published in 2003, over a year before the results of the prospective, randomized, controlled IDE trial of the CHARITÉ. Artificial Disc were made public, and over two years before the results were published in the peer-reviewed literature (Spine, 2005). Therefore, this article is outdated.

The paper by van Ooij reporting complications in 27 patients is cited as is the fact that these patients are from an original cohort of 500 patients. This yields a known complication rate in these patients of 5.4% (which is not cited in the memo). This is a lower complication rate than in the IDE study. Also, not fully taken into account is the fact that again, these cases took place when the indications for lumbar disc replacement were highly variable (unlike today), with a limited number of device sizes (unlike today), and with basic first generation instrumentation (unlike today).

All of the papers named above were published prior to the completion of the IDE study and publication of the results in Spine.

The paper by Putzier et al (European Spine Journal, published online, 2005) is given significant attention in the memo because it represents the longest published follow-up of patients implanted with a CHARITÉ Artificial Disc. Tables in the memo show a distinction between SB I, II, and III models of the device but the memo fails to take into account that this is the earliest clinical use of the SB III device. Indications, sizing, and instrumentation are all important distinctive issues compared to what is known and in use in 2005. Prof. Dr. Karin Büttner-Janz disputes the accuracy of these data from the Charité hospital as it does not match with her data and these were her patients. Note: A letter to the editor from Dr. Büttner-Janz will be published in the March, 2006 issue of European Spine Journal.

Lemaire and David are criticized for reporting clinical results without the use of ODI, VAS, or SF-36 scores. At the time data collection began on these patients in 1989, none of these clinical outcome instruments were validated or in widespread use to measure pain and function in low back pain patients.

No formal training was available at the time these early studies were conducted. Since FDA approval of the CHARITÉ. Artificial Disc, all spine surgeons who implant the device in the US must undergo a training course sponsored by DePuy Spine at the Center for Spine Arthroplasty in Cincinnati. This comprehensive course includes didactic and hands-on training.

Throughout the memo, revision rates from various studies are cited. However, revision rates for lumbar fusion are equally high as reported by McAfee (2005, NASS) and as reported by Medtronic Sofamor Danek (INFUSE® SS&E, Federal Register, 10.4% reoperation rate for patients receiving LT-Cages and INFUSE for lumbar fusion). Federal Register, May 26, 2004. http://www.fda.gov/cdrh/PDF4/p000054b.pdf

The IDE study of the CHARITÉ Artificial Disc is a landmark study in the history of spine surgery and represents the only prospective, multi-center, randomized, controlled study to date of two different surgical treatments for the treatment of low back pain. The Orthopaedics & Rehabilitation Panel of CDRH performed an exhaustive review of the results of the study and unanimously recommended approval of the device.

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I appreciate the thoroughness of this website. However as a health care provider and one who treats difficult spinal patients on a daily basis, I would ask to reconsider the non-coverage decision re:"artificial discs" or "disc arthroplasty. I have performed this procedure and again I feel the key to the success of disc arthroplasty is "patient selection". The criteria for surgery in this regard is very strict. Only a small percentage of patients with discogenic back pain are even a candidate under the criteria. These patients would now be relegated to a chronic pain clinic which I have never been impressed with success of either the patients clinical outcome or even a return to work status. The other option is a surgical fusion with the very high risk of future surgery for adjacent level disease. With the appropriate training including patient selection, the disc arthroplasty is very needed treatment option for these otherwise miserable chronic patients. Each of my patients without exception who have had arthroplasy have been pleased, reduced narcotic load, and returned to work. I realize this is a skewed population but in my opinion, "it works".

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March 15, 2006

To Whom It May Concern:

I am writing an appeal response to the recent ruling of CMS not to support reimbursement of the Charite artificial intervertebral disk replacement. I believe this decision is an error for many reasons.

The surgical intervention for the management of symptomatic degenerative disk disease often portends a less than satisfactory outcome compared to radicular disease or leg pain and spinal stenosis. It has been found to be highly effective in a select group of patients with a single, or rarely, a two level pain generator (disk) unresponsive to a minimum of six months of nonoperative treatment. A small percentage of patients covered through CMS under the age of 65 may benefit greatly from surgical intervention and should be allowed, like the general population with private insurance, to have the opportunity to be treated with a device intended to allow controlled motion rather that stiffness as with a surgical fusion.

It is well known that a device such as the Charite intervertebral disk would not be an optimal implant in a patient with evidence of osteopenia or osteoporosis due to implant subsidence or migration. It would be highly effective in patients who are disabled and on Medicare below the age of 65 who have mechanical low back pain without significant posterior facet disease. As such, I would recommend the approval of this device in carefully selected Medicare beneficiaries.

Restrictions on its use should be clearly outlined such as in the presence of osteopenia or osteoporosis identified through DEXA screening. Patients with a score less than 1 standard deviation below the norm would be candidates for this device. Patients with advanced or symptomatic posterior facet disease also would not be candidates for this treatment. By not allowing this form of treatment for patients covered through CMS, patients who are younger than 65 with significant disability due to mechanical back pain indicated for surgical intervention would be relegated to a fusion procedure which may predispose to junctional degenerative disease above and below their fusion.

It is clear from the study of Blumenthal et. al. Spine, 2005, a prospective, controlled, randomized study (Level 1 evidence) that the Charite device demonstrated equivalency to the fusion group. Only 5.4% of Charite patients required a revision procedure compared to 9.1% of the fusion group. Seventy-eight percent of patients receiving the Charite artificial disk had at least a 10 point improvement in their ODI. A recent MDR submitted by DePuy to the United States Government following approximately 4000 implantations noted a complication rate lower than the IDE study and initial training cases which were performed by carefully selected surgeons with an interest in the development of this technology.

The general safety of this technology was also illustrated in the paper by Geisler, Journal of Neurosurgical Spine, 2004 where he looked at the neurologic complications of lumbar artificial disk replacements compared to lumbar arthrodesis. The authors of this study examined 25 papers with 29 separate data sheets and found that the Charite artificial disk compared similarly in terms of ODI score improvement from baseline to 24 months with the fusion groups. A long term outcome analysis by Lemaire et al. in the Journal of Spinal Disorders, 2005 noted that at ten years, patient satisfaction after implantation of the Charite device was approximately 90% and patients demonstrated approximately 10.3 degrees of flexion/extension and 5.4 degrees in lateral bending at follow up. Ninety-two percent of patients were eventually able to return to work. Finally the paper by Scott-Young in Spine, 2004, looking at revision strategies for lumbar disk replacement, noted a revision rate of only 2.7% in their patient population at follow up.

In summary, it would be an extreme disservice for patients on disability due to low back pain receiving insurance through CMS not to have the opportunity of receiving a surgical implant intended to spare and restore controlled motion rather than a fusion procedure. This technology may significantly limit the consequences of a stiffing procedure and its potential consequences such as loss of motion, junctional degenerative disease and loss of spinal balance. Like fusion procedures, the intervertebral disk prosethesis is finding a role as an optimal device for select patients with symptomatic lumbar degerative disk disease.

Sincerely,

Alexander R. Vaccaro, M.D.AV/lmy

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To Whom It May Concern:

As a spine surgeon, I fully agree with the CMS decision to recommend non-coverage of total disc replacement. Dr. Deyo's comments on the Charite device are balanced and appropriate.

Depuy Spine, the manufacturer of the Charite artificial disc, is currently orchestrating an aggressive "letter writing" campaign asking surgeons to write CMS and request that coverage be granted. After receiving an e-mail from the company, I felt compelled to write and voice my strong support for non-coverage. I believe that the Depuy strategy is self-serving and is clearly intended to bolster the device's stagnant sales figures.

Respectfully submitted,
Samy Abdou, M.D.

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I am absolutely bewildered by the recent noncoverage proposal by CMS for disc replacement technology! Cited were three papers all from the 1990's when the technology and instrumentation were less refined and completely inferior to what is available currently. First the reviewers should completely ignore all of the cited studies and begin by reviewing the IDE study that our own government designed and reviewed and based on this study gave full approval for disc use!!! Secondly they should review articles by Lemaire, Bloomenfeld and MacAffee all published in the last two years in peer reviewed journals that discuss and answer with scientific support all criticism of disc replacement technology.

In the proposal for noncoverage there is cited a lack of evidence for indications for the technology. Incredible read the IDE study which clearly defines the patient population the device should be used in. Also in the proposal for noncoverage issues of anterior approach and revision were brought up and the author completely ignores that ALIF is performed in tens of thousands of patients safely in our country yearly, and with minimal complications as for any surgical approach. The author also completely ignores that the primary revision strategy for a failed disc replacement is a posterior fusion with instrumentation THE SAME as the revision strategy for a failed ALIF which I remind you again is performed in many thousands of patients each year.

Current data on the use of disc arthroplasty in the US do not show a "Cage Rage" as what occurred in the 1990's with Ray and BAK cages but rather judicious use and less complications than were observed in the IDE study!! Five year follow-up data on the IDE patients is just now becoming available and it demonstrates that the patients are doing even better than they were at two years!! I strongly urge the CMS committee to hear data from the IDE surgeons before making a horribly uninformed decision.

Lastly, I ask the CMS committee and in particular the author of the noncoverage proposal, are you looking out for the needs of the beneficiaries that you are charged for caring for???? There are more than SIX MILLION AMERICANS who are covered by medicare and are under the age of 65. Many of these are on disability for LBP. You may be taking away a FANTASTIC TOOL in our "bag" for caring for these patients who you represent!! How do you think they would respond if they were there to hear you make a decision such as this based on inadequate and noncurrent information. I guess that one could understand if coverage was not extended at this time (until more studies could be performed) on Medicare beneficiaries over the age of 65 but not for those below that age which the IDE study clearly defined as excellent candiates for this technology if they meet the indications.

I have performed a disc replacement on a 69 year old female who had normal bone density by dexa scan. She has had an extraordinary result and credits this technology for giving her a "new lease on life". She will undoubtedly be writing you a letter trying to convince you to reverse this proposal just as I have. I pray you wake up and take a look at recent, relevent data and realize that you are there to represent millions of people who depend on you not to make hasty, incorrect decisions.

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I read with interest your review of total disc arthroplasty. I was concerned about some of the data cited in your review. Several of the papers used in the determination of coverage were published prior to the completion of the IDE study. As a surgeon who has used the device, I can say that the indications are very well defined in the IDE study and the manufacturer has been aggressive in making sure that those are adhered to. In addition, the anterior approach is a common approach in similar spine fusion proceedures. In regards to the concerns about revision surgery, the primary revision approach is posterior, thus eliminating the vascular concerns of a repeat anterior approach.

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It is very disappointing to know that CMS is considering a national non-coverage determination for the Charite' artificial disc. As a spinal surgeon who performs total disc replacement surgery I have seen many patients benefit greatly from this procedure. One such patient is a 38 year old woman who was diabled for 3+ years due to chronic low back pain and a damaged L5-S1 disc, out of work, taking narcotic medication on a daily basis, and failed mutiple other expensive therapies. After I performed a total disc replacement for her she is no longer physically disabled and is weaning off narcotic medication. It has been a life-changing surgery for her. The vast majority of CMS patients are not 38 years old and are not candidates for total disc replacement (TDR) surgery. However, there are certainly patients with medicaid or disabled and on medicare with the right indications for TDR. A non-coverage policy by CMS on TDR would deny these patients an important treatment alternative for chronic low back pain. Just imagine the cost savings for a successfully treated patient who come off of disability!. A non-converage policy by CMS may prompt other insurance carriers to follow suit and deny coverage as well for many more patients. This will also make it difficult for other artificial discs coming to the market to be covered by insurance carriers.

CMS should consider the fact that the Charite' artificial disc clinical trial was one of the most rigorous scientific studies ever perfomed for a medical device and surgical procedure. The Orthopaedics and Rehabilitation Panel of CDRH unanimously recommended approval of the device based on the data from the FDA trial.

In the Proposed Decision Memo (PDM)on the Charite' CMS cites the review paper by Kleuver published in 2003. However, this paper was based on the literature up to 2002 which was more than a year before the results of the first prospective, randomized, controlled FDA IDE trial of the Charite'disc. The paper by Van Ooij is referenced to cast a negative light on the Charite' disc. This paper only mentioned a series of complications in 27 patients with the Charite'. It fails to mention that these patients were part of a larger cohort of 500 patients which would make the rate of complications in this cohort about 5.4%. The Van Ooij study as well as many others cited in the PDM were published when the indications for TDR were still being establihed and the surgeries were done with first or second generation implants with limited implant sizes. The surgical technique and instrumentation for implanting the device has also evolved.

The PDM also mentions surgical revision rates from several studies on Charite' but fails to mention the fact that published revision rates for lumbar fusion (the alternative to TDR) are as high or higher than TDR. The revison rate in the FDA IDE trial was 5.4% for the Charite' and 9.1% for the fusion group.

Scientific evidence aboutthe Charite' disc continues to be published. In February 2006 Geisler reported clinically superior results in Charite' treated patients with improved VAS and ODI scores when compared to patients with fusions. At the same meeting McAfee performed a Kaplan-Meier regression analysis on 359 patients with Charite' compared to those with fusion and found 92.4% survivorship in Charite' compared to 80.1% for fusion. The reoperation rate was 4.6% for Charite' and 13% for fusion and adjacent level disease requiring surgery was 0.6% for Charite' and 5.6% for fusion.

CMS should not issue a national non-coverage policy on the Charite' total disc arthroplasty procedure. Such a decision will deny many patients an excellent alternative to fusion in the treatment of disabling low back pain. CMS should allow coverage for this procedure for patients with appropriate indications as cited in the FDA IDE clinical trial and assure that the surgery is performed only by qualified surgeons trained in the technique. CMS should continue to monitor clinical results as they become available in the literature and amend policy in the future if necessary.

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Dear Mr. Secretary:

I am an Associate Professor at the University of Wisconsin and an academic orthopedic spine surgeon with a background in Chemical Engineering. I have been president of several organizations and have published over 100 articles. I am writing this letter to help give CMS perspective regarding lumbar disc arthroplasty including the Charite device. I have not performed this procedure and have no relationship with Johnson and Johnson.

At this time CMS stands as the second regulatory door for technology such as arthroplasty. Although CMS looks primarily at Medicare patients, it has a great influence on the decisions made by other third party carriers for other populations. Should CMS begin to reject treatments simply because they are inappropriate for patients over the age of 65 the implications may be devastating. For instance, if CMS were to deny approval for a drug or procedure that is only used in pediatric patients because it doesn’t apply to Medicare patients you could be withholding important treatments from children. A similar argument exists for adults younger than 65 years of age who have back pain and may be candidates for spine arthroplasty. If you set a precedent like this the result may be that you will be encouraging enrollment into clinical trials of products that are not intended for use in older patients just to obtain CMS approval. This could potentially harm such Medicare patients.

Specifically regarding spine arthroplasty in the lumbar spine, the device will rarely if ever be used for patients in the Medicare population because of their age (older than 65 years). However, Medicare patients in younger age groups may fit into inclusion and exclusion criteria and therefore this surgical treatment may become a covered benefit. The testing of the device in my view was rigorous and assures safety and efficacy. Although the investigational studies demonstrated functional results which are similar to fusion, additionally, maintenance of motion was observed. It is hoped that this will result in fewer re-operations for adjacent segment degeneration. Unfortunately, it will take 5-10 years before that could be determined. Another benefit that is shown is a lower re-operation rate in the short-term. This could have significant financial benefits that offset some of the additional costs for spinal arthroplasty.

In regard to Dr. Deyo's comments, he is correct that little evidence is available that lumbar arthroplasty is safe and effective in Medicare patients and that it should not be used therein. This is self-evident since this patient cohort was not part of any of the studies. Dr. Deyo is a researcher and not a practicing physician and does not have clinical experience to gain insight. He does not understand the difficulties in treating individual patients who are suffering nor the needs of these unfortunate individuals. Also, in his analysis and in your synthesis, the importance of maintaining range of motion is ignored.

I believe the Charite device has been reviewed and approved by the FDA. Given the evidence that the device is safe and as effective compared to fusion, CMS should not take steps that would result in withholding the device from all patients. It is unfair and would negatively impact patient care for CMS to look only at the Medicare population and formulate an adverse opinion that may affect patients of all ages and multiple payment sources.

Sincerely
Paul A Anderson MD

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I believe the artificial disc technology has a definite role in spine treatment. It certainly is not for everybody, and it may be a small population that can actually benefit from this surgery. Younger patients with incapacitating back pain, without instability, I believe will be better with a motion sparing device rather than a fusion. In order to prove the value of this technology, we must have continued access to patients. We can get more data with more procedures. Surgeons need to stick to the indications and contraindications to have good outcomes. These have been well outlined and defined.

The CMS should not promote a non-coverage decision, as this will limit patient and surgeon options. I believe it is wrong for the CMS to dictate surgery options. We as surgeons should be able to offer the best treatment for our patients. A negative decision by the CMS will set a precedence for any new technology, and will eventually halt medical progress.

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Lumbar total disc arthroplasty is an essential option for the care and treatment for patients with disabling low back pain and degenerative disc disease. The Charite disc prosthesis has been proven to be as safe as lumbar interbody fusion using BAK cages. The Charite disc prosthesis provides the added long-term benefit of allowing motion at the surgery site and a potential reduction in adjacent segment degeneration and the potential need for additional spinal surgery.

I strongly recommend coverage and payment for all Medicare beneficiaries.

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I believe this technology revolutionizes the treatment of Degenerative Disc Disease of the lumbar spine, especially in young and active patients. Lumbar fusion can elimate the pain and discomfort in this group of patients. It can also decrease future cost for lumbar spine fusion. Since 2000, I have been doing lumbar Disc Arthroplasty and have followed my patients more than five years. More tha 80% of patients are happy and very satisfied with the procedure, and none of them have undergone surgical intervention for the adjacent level. My patients can participate in athletic activity and most of them are working and have returned to a normal function of life. A few number of those patients have Medicaid. One in particular was a truck driver who had been off for two years prior to surgery. He returned to work two months post op. As a Surgeon I believe we should have the technique in our hands for a selective group of patients which would benefit from this surgery.

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THe vast majority of the medicare polulation is not a candidate for this procedure. One of the contra-indications for total disc replacement is degeneration of the facet. this is present in nearly all medicare age patients.

The most conerning aspect of your decision that like it or not commercial insurance companies use medicare to guide coverage for their enrolees. Motion preservation is a revolutionary advancement in the treatment of spinal disorders and the conern is that commercial insurance companies will use the CMS's decision as a chance to not provide this treatment as a covered benfit.

I believe that some of the conclusion of CMS's review were in error. The design of the IDE clearly defined which patients were candidates for this procedure. This is contrary to CMS conclusions.

It is my opinion that CMS should reverse its decion as total disc replacement offers a real alternative to lumbar spinal fusion.

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Disc replacement surgery, as compared to lumbar fusion, offers preservation of motion segment and prevents adjacent level degeneration, thus obviating future surgery at the adjecent level. This, in itself, save millions of dollars of direct costs and more in indirect and opportunity costs. As a spine surgeon, I am morally obligated to inform my patients of the best treatment options. CMS decision denies patients of having this best option since most insurance companies will follow CMS guidelines. Please don't do this to your own people.

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I am an orthopaedic spine surgeon trained in Charite ADR. To date, I have performed the procedure on 6 patients. Longest follow-up is 1 year. So far, there have been no complications or device related failures. Altough the follow-up is short my patients are happy with their results to date.

As with any new device, the key is proper patient selection and meticulous technique.Charite ADR has in my opinion a definite place in the spine surgeon's armamentarium.It would be unfortunate and unfair to the consumer if this procedure is categorically denied by CMS.

On the other hand, if strict inclusion and exclusion criteria are developed along with an ongoing database and follow-up measures, ADR will find its useful place in the realm of spinal surgery.

Motion is always preferable to fusion wherever applicable and in the case of painful degenerative disc disease this is certainly the case. it is important that we as spine surgeons do not give up on this sound concept but continue to improve the products safety, reliability and longevity.

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Dear CMS:

I am an orthpaedic spine surgeon that has a sizeable population of patients that have received the Charite artificial disc arthroplasty. Of this population, I have performed this surgery on two (2) patients in the Medicare population.

The first patient was 68 years of age and did extremely well. He was unable to perform daily activities without severe pain prior to the surgery. He now is able to golf, farm and perform all daily activities without pain or restriction of motion.

The second patient was 45 years of age and on Medicare secondary to an unrealted disability. This patient suffered additional daily pain from degenerative disc disease. She underwent the Charite artificial disc arthroplasty and has done extremely well and has had no complaints of pain since surgery. She has even weaned off all narcotic pain medication she was taking prior to the surgery.

Although these are only two of my patients, I have similar results in the other 100 patients I have performed this surgery.

To determine that the artificial disc is not reasonable and necessary is an oversight in the finest technology available to spine patients in years.

In my limited experience, these surgeries take less time, cost less, and have far less rehabilitation times than other surgeries for the same etiologies (i.e. fusions). The return to work times are much less and the patients are much happier than the other surgical population.

This surgery is not for everyone. It has strict indications/limitation, however, if these guidelines are followed closely, the patients recover better than any other modality we currently have available.

I would ask that you reconsider your initial decision as it bears no merit and is short-sighted.

I am available for questions or any further comments.

Thank you for your consideration.

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I have reviewed the entire scope of literature regarding spinal arthroplasty and been involved in the IDE study for the Charite Disc as well as other IDE studies for cervical disc arthroplasty and feel that I speak from a position of being well informed as are many of the other respondents. The denial if the Charite disc as authored by Dr Richard A. Deyo on behalf of the CMS on August 16, 2005 is unfortunately fraught with a number of innaccuracies and errors. This is admittedly coincidental with the potential inaccuracies of the Charite study, however the lack of objectivity in the CMS report is unfortunate. Dr. Deyo had a concern that, “the Charite disc is a new technology whose real place in spine therapy remains to be determined,” and that important scientific evidence generalizing safety and effectiveness is not available.This statement is indeed true for a number of reasons. First is that lumbar ADR is not indicated for patients in the Medicare age group due to concerns of bone density. Other important factors revolve largely around the facts that 'evidence based medicine' in the spine is really in its infancy and obtaining objective data for this extremely diverse disorder is very difficult. The FDA IDE study was a good attempt at creating an accurate lumbar spine study but obviously has a great deal to be improved. Lastly the outcomes of these devices will not be resolved in a few short years and many years of followup will answer many more questions. In summary I feel the CMS denial was innappropriately overbroad and could have been summarized to deny the selected group of Medicare patients who the device was not intended and simply defer the recommendation for further study on the population for which it was intended.

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Why would CMS render a decision about a technology that has not been fully investigated in the medicare population? Particularly if that decision will impact adoption by commercial carriers for populations of patients for which there is more than adequate evidence for it's safety and efficacy. CMS should not be unduly influenced by a select few with a bias against surgery in general. Why is it that those with the loudest voice against certain technologies, far more often than not, have no direct experience with the surgery, the patients or their outcomes from these interventions?

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I read with interest Dr. Deyo's recent letter to CMS regarding the use of artificial disc replacements (ADR) in the medicare population. I have been performimg artifical disc replacements for 3.5 years in the USA. In addition, As a result of a close cooperation with a leading European ADR facility, I have performed ADR surgery in pts over the age of 65. I recently published this prospective work on pts over 65 in the Journal of Neurosurgery (Lumbar total disc arthroplasty in patients older than 60 years of age: a prospective study of the ProDisc prosthesis with 2-year minimum follow-up period.J Neurosurg Spine. 2006 Feb;4(2):85-90. PMID: 16506473. We found statistical improvement in outcomes in these patients. We had a single case of subsidence in one of our early patients which has been asymptomatic. I also care for medicare and medicaid pts that are under the age of 65. Often, the primary reason they are on medicare is because of their back pain. ADR surgery is a very effective method of reducing LBP in this age group as well as evidenced by the recent approval of both the Charite ADR as well as the recent approval of the Prodisc ADR. I have also published prospective work on this topic as well The treatment of disabling single-level lumbar discogenic low back pain with total disc arthroplasty utilizing the Prodisc prosthesis: a prospective study with 2-year minimum follow-up.Spine. 2005 Oct 1;30(19):2230-6. PMID: 16205353. In summary, ADR surgery has completely changed the landscape of lumbar surgery in my practice in an extremely positive way. I am not asking to perform ADR surgery in all medicare pts. Only in those pts who meet all physiologic and biologic criteria as is the case in any surgical procedure for any human being in need of comfort and pain relief. There are many patients older than 65 who must work to provide for their families and who have excellent bone density values whose lives could be positively effected by a positive coverage CMS decision for ADR surgery. I hope you strongly consider my first hand experience and publications over the opinions of individuals who may have neither. I would be happy to personally discuss this issue in more detail with you.
Sincerely,
James J Yue, M.D.
Chief Spine Surgery
Yale University
New Haven, CT 06520 USA

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I am an Orthopedic Surgeon practicing in Los Angeles California since 1984. My practice is limited to the evaluation and treatment of patients with spinal disorders. I am the director of a spine fellowship program, and teach young surgeons how to effectively treat spinal disorders.

In your decision making analysis regarding the Charite III total disc replacement, I think you are overlooking a very significant issue regarding the appropriateness, safety, and effectiveness of this implant. All of the discussions I have seen relate to the use of this implant in an individual with degenerative disc disease but otherwise normal anatomy. In this setting, most practitioners would agree that a single level fusion is equal to or better than a total disc arthroplasty, and can be done with a posterior approach, avoiding risk of injury to the great vessels from an anterior approach.

There are many individuals, however, of all age groups that have had prior spinal surgeries, including spinal fusions that limit lumbar flexibility. In those instances, additional level fusions are likely to produce far greater functional limitations than the total disc replacement would in those circumstances. In other words, if someone has already had a lumbar fusion from prior trauma (spinal fracture) or scoliosis surgery, the preservation of lumbar mobility from the total disc replacement could mean the difference between someone who can perform his or her own toilet care and one one who cannot.

For these (and other) reasons, I recommend that Medicare pay for the Charite III total disc replacement when used within the FDA established guidelines while additional clinical experience with this device (and its competitors) is accumulated in the scientific literature.

Thank you for your consideration.

Sincerely,

Todd D. Moldawer MD

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As a clinical IDE investigator for the Charite, and a busy fellowship-trained, doubly-boarded spinal surgeon, I read with great concern, the proposed NCD by the CMS for the Charite Artificial Disc Device. It appears from the CMS release that their decision is largely based on the opinions of Doctor Deyo, who is NOT a practicing orthopedic or neurological spine surgeon. In his self-proclaimed role as protector of the unsuspecting and the taxpayers, he did not take into account any of the peer reviewed literature or could not understand the results of study which showed valid Class 1 evidence of the safety and efficacy of the Charite device. In carefully reviewing papers written by Blumenthal and McAfee, already published in the Journal of Spine, the improvements in pain and function, patient satisfaction, maintained motion, extremely low incidence of revision and low complication rates compared to spinal fusion, are well-documented at 24 months post-surgical, and trending better at five years follow-up.

The aforementioned, as well as new data set forth by Dr. Fred Geisler, by Dr. Richard Guyer, and by Dr. Paul McAfee, have shown superiority statistically significant to a p value less than 0.5 especially in patients between the ages of 45 and 60. Doctor McAfee provides an elegant predicted five year survivorship artificial lumbar disc vs. ALIF with a survivorship analysis using Kaplan Meier regression of 92.4% when compared to a fusion group at 80.1%, statistically significant to a p value of 0.003. The survivorship in the Charite group predicted at long term is even higher approaching 95-96% where other arthroplasties, at the same period of time, show survivorship of less than 80%. When reviewing the adverse event profile, in the IDE study of the Charite, a total of 2.1% device related AEs were noted vs. 7.2% for the fusion group.

Clearly if one is not cognizant enough to comprehend this Class 1 peer-reviewed USA data, it may be prudent to consider the European experience where many centers have large numbers of Charites closely followed for greater than 10 years. The safety and efficacy of this product is confirmed in the works of Dr. J.P. Lemaire, published in the Journal of Spinal Disorders (an American journal), as well as the works of Dr. Matthew Scott Young , published in the Journal of Spine 2004 (another American journal). Even the work of Dr. Andre Van Ooij who is a detractor of the Charite confirmed only 45 complications in Charite disc replacements in a single surgeon series of greater than 1000 implants. This generically is a 4.5% complication rate, which still remains significantly lower than reported complication rates for other spinal procedures.

Having had the good fortune of treating several younger disabled patients who were covered by Medicare (because of their disability) the use of disc replacement has been life-altering for these patients in a positive way. It is my belief that even for this small segment of your covered population, this technology can not only improve quality of life, but has returned many previously disabled patients back to work, thus lowering the long term expense for these patients, who are no longer disabled.

This is an impassioned plea for the CMS not to make a knee-jerk decision while continued long-term studies (five year outcomes at present with ongoing studies to ten years in the IDE group) are still underway. Time is our ally in this endeavor. Please act carefully and judiciously for the benefit of all spine disabled patients.

Sincerely,

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I urge CMS to cover the Charite artificial disc. Charite offers a new avenue of treatment for patients with degenerative disc disease. It has proven itself in FDA run trials. If CMS chooses not to cover Charite, it will limit all patient's access to this device since other insurers are likely to follow suit. Furthermore, a noncoverage will have a chilling effect on clinicians running class I FDA approved studies if the results of those studies are going to be questioned by and disapproved of CMS.

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The Charite artificial disc is not appropriate for the majority of the Medicare population. However, for the younger, disabled Medicare patient who meets the defined criteria for artificial disc, this may be their only reasonable option. I have implanted a large number of the Charite discs with fantastic results. My operative group includes patients that were not good candidates for fusion due to their young age and multilevel degenerative spine disease that would have required multilevel fusion. But, when treated with the artificial disc at the most severe level responded very well. The decision to deny access to artificial disc technology to this population closes the door on their most hopeful prospect for relief of their chronic pain.

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Dear Sirs: I am writing as a member of the Executive Board of both the North Carolina Spine Society as well as Carolina Neurosurgery and Spine Associates, one of the largest neurosurgical practices in the country. CMS has done an exhaustive review of the literature related to the Charite Artificial Disc Replacement. There is no question that the Class I evidence from the Charite FDA IDE study dominates this body of literature in terms of its scientific validity. All the other published literature, both positive and negative, cited in CMS' noncoverage recommendation pale in comparison to this prospective, randomized, controlled trial. The strength of this data led to the FDA approval of the Charite Disc. A central tenet in CMS' noncoverage recommendation is the applicability of the scientific data to the Medicare population. The question is whether this novel surgical treatment for mechanical low back pain is 'reasonable and necessary' for CMS beneficiaries. There is legitimate concern surrounding the paucity of data in the elderly population. Certainly, the role of total disc replacement in the elderly will remain relatively limited. But, it is important to recognize that in this increasingly healthy and vibrant age sector of over 35 million, there will surely be some applicability. CMS' disabled population (over 6 million) represents an entirely different population. The results of the IDE study are directly applicable to this population. In regard to the reasonable and necessary criteria, disc arthroplasty with the Charite Disc represents an innovative treatment modality. There is no surgical treatment alternative for lumbar spondylosis/degenerative disc disease with mechanical low back that maintains motion. By making the decision to deny coverage to the disabled population of an FDA-approved device, CMS is, in effect, rationing health care resources to this specific population. Although CMS' primary obligation is to its coverage population, it would be disingenuous to discount the negative effect a CMS noncoverage decision would have on private insurer coverage of the Charite Disc and total disc replacement in general. One basic philosophical question that cannot be ignored is that if a device/treatment is found to be safe and effective by the FDA, who decides whether that device/treatment should be used in an appropriate patient population? Should that decision be made in the confines of the physician/patient relationship or should it be made by insurance carriers, either the government or private insurers? CMS should not underestimate the negative impact of a noncoverage decision on physician autonomy in patient care decisions as well as patient access to novel technologies, unless, of course, that is the intended effect of such a decision. Certainly more scientific data on the Charite Disc is forthcoming. The data from the IDE study supports coverage of the Charite Disc, at least in CMS' disabled population, until more conclusive data is available. This would allow for medically reasonable and necessary coverage while continued scientific scrunity ultimately determines the long-term efficacy of lumbar total disc replacement. Thank you for your consideration.

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The decision of CMS to consider "a national noncoverage determination" on the basis of Dr. Deyo's letter and ignoring the strongly positive public comments is truly irresponsible. The indications for spinal disc arthroplasty exclude patients with osteopenia, instability,and facet arthropathy. These exclusion criteria are for patients of any age and would be used in Medicare and Medicaid patients. One could argue that most Medicare patients will be excluded from receiving a total disc using these criteria, but those who do meet the "labeled" indications should not be denied this important technology. A denial of this specific device would likely have an effect on the introduction of other total disc devices and will also effect the willingness of the private insurance market to provide payment.The Charite Total Disc has been shown to be both safe and effective in a Class 1 FDA study and if Medicare or Medicaid patients have the correct indications coverage should be provided.

Richard Salib, M.D.
Institute for Low Back and Neck Care
Minneapolis, MN

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While I agree with you assessment and data review specifically that these discs have limited utilization in the 65 age plus population. The difficulty with this decision to not cover this technology is that clinically the options to the axial pain population is limited. Patients can be disabled and covered with Medicaid insurance. The artificial disc provides another device and treatment modality is a difficult patient population. In addition the prospective designed study illustrated that it decreases pain again in a patient population with limited options. I therefore believe that further review of your decision is necessary
Thank you
Jim Harrop MD

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I am a neurosurgeon in private practice. I have been in FDA investigator for two artificial disk devices in the cervical spine. I have also been involved as an FDA investigator with two fusion cage devices, one in the low back and the other in the cervical spine. I have taken the Charite training course.

I am opposed to Medicare of artificial disk technology for low back pain at this time.

My opposition is based on the expense that this will incur and the failure to achieve results that are dramatically better than what we currently are achieving without the new technology.

I worry that our finite medical care dollars will be squandered not on treating life threatening conditions like cancer and heart disease but instead will go to making people with complaints of back pain marginally better.

None of the people treated with lumbar artificial discs are at risk of paralysis nor death, yet the tens of thousands of dollars are incurred in each case treated.

As my old professor used to say, "each year, thousands of patients die with low back pain, and in each case they also had a serious medical condition"

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Because of the trend towards nationalized healthcare that is being pushed by the insurance carriers, ALL insurance carriers look to CMS regarding administrative practices. Because artificial disk replacement has a usefull niche in younger patients with limited disk degeneration, this won't impact CMS to any significant degree, HOWEVER, if CMS chooses not to cover this procedure, it will significantly impact the young people who could benefit from this procedure. All I can say regarding the efficacy of the procedure is that I have done it in a selected few patients who had no evidence of arthritis (only disk disease) and I have had very good outcomes.

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I am a neurosurgeon in Baltimore and operate predominantly on patients with complex lumbar and cervical problems.

I welcome the decision of CMS to withdraw funding for the artificial disk. I participated in the surgeon training offered by the Charite disk manufacturer and feel strongly that the technique of anterior lumbar disk prosthetic replacement is not currently safe enough to be widely used by a large number of surgeons.

I believe that there are extremely few patients who may potentially benefit from such a risky implant and that further study of the long-term efficacy of these devices should be undertaken prior to adoption of this method nationwide.

At the same time I would advocate that a compassionate use exception clause be instated and payment be provided by CMS for the few cases (I would estimate less than 200/year nationwide) that would meet strict criteria and only if superiority of this experimental technique over proven surgical methods can be clearly demonstrated.

Please e-mail me if you wish for me to comment further.

Thanks

Bernhard Zunkeler, M.D., F.A.C.S.

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CMS decision seems appropriate for the elderly. Certainly, with growing costs to Medicare, only technologies proven to improve care should be advanced. I am not sure this is the case, even in young individuals. Furthermore, a vanishingly small percentage of the Medicare population might be appropriate candidates. Based on previous experience with new technologies, these devices are likely to be implanted in many individuals who should not be considered good candidates.

However, I am concerned that at CMS denial will negatively impact other payors who cover more of the population who MIGHT truly benefit.

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As a neurosurgeon with advanced fellowship training in spinal surgery, I treat a wide spectrum of spinal disorders. I believe that artificial lumbar disc replacement is a valuable tool for a subset of patients that meet the eligibility criteria as outlined in the FDA-approved trial. To exclude coverage for a Medicare patient that meets these criteria is to limit patient and surgeon choice of an effective treatment. I personally have utilized the Charite disc for a Medicare covered patient who was 44 years old. She was on Medicare disability. She met the stringent criteria for implantation and did very well from a clinical perspective. I believe if the data are compiled that the findings nationwide would support this. Please do not limit patients options with a non-coverage decision.

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I do not agree with your conclusion to not cover artificial disc. The data does show that in "CAREFULLY SELECTED PATIENTS" that total disc is a safe AND efficacious procedure. Although the Medicare utilization will not be high with this device there is a subset of the population that will be denied the benefit of this procedure. The exposure to Medicare is low and in fact the surgery may generate less costs and complications than a 360 fusion which many surgeons choose over disc replacement. The benefit to a few patients may be great.

Please reconsider this decision.

Sincerely,

Pierce D Nunley MD
Director,
Spine Institute of Louisiana
Shreveport, LA

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While I agree that there may be a minority of Medicare age patients for whom this disc would be appropriate, I believe it should be approved in a limited manner for selected patients.

The implications of Medicare giving a blanket denial of coverage for this implant are that insurance companies, who cover the patients for whom an artificial disc would be appropriate, have a supposed justification for denial of this treatment, in essence withholding care from the patients most suited to this arthroplasty.

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I am a spinal surgeon in Portland oregon uring you to reconsider non coverage for total lumbar disc replacements. This is a viable alternative to fusion that is studied and FDA approved. It has evidence based proof that is at least as good as fusion in the short term. The resistance by the payor community for the introduction of this option is in my opinion unprecendented and is ushering in a new era of innovative oppression.

I am concerned about the countries ability to lead in medical advancement given the current US working environment. Although the over 65 age population is not in general a common candidate for this procedure they should not be discriminated against based on age. To believe that this will not have an impact on coverage by other carriers is naive. This is an excellent example how the government through medicare is a price setter and policy setter in a payor industry whose goal is to limit access to care for financial reasons. This is unique and un-american.

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IN SUMMARY, ARTIFICIAL DISC REPLACEMENT IN THE LUMBAR SPINE APPEARS TO BE EQUIVALENT TO STAND-ALONE ANTERIOR LUMBAR INTERBODY FUSION AS A TREATMENT OPTION FOR LOW BACK PAIN BELIEVED TO BE SECONDARY TO (PAINFUL) DISC DEGENERATION. These were the findings of the IDE study. A second study comparing ADR to anterior posterior fusion demonstrated similar results. SEVERAL CONCERNS REMAIN. First, stand-alone interbody fusions are rarely performed anymore. Second, considerable debate remains over the nature of low back pain and its relationship with disc degeneration, i.e. does disc degeneration cause pain, and if so, can it be treated surgically? Third, several non-structural, psychosocial factors appear to significantly affect/modify the experience of low back pain, and these are not treatable surgically. Forth, the overall success rate of the IDE study was 58% for disc replacement vs. 54% for fusion, both results were far from excellent. Fifth, pain improvement was not included as an outcome measure, and pain "unresponsive to conservative measures" is the primary indication for these procedures. I believe that a large number of the patients with "successful" results in the IDE study continued to require pain management with narcotic medications two years post-operatively. The question at hand is should this procedure be covered. I BELIEVE THAT ARTIFICIAL DISC REPLACEMENT SHOULD BE COVERED. Despite all of the above concerns, many carefully selected patients have good or excellent results from fusion procedures as a treatment for low back pain. Even those who consider themselves quite conservative or even "anti-surgery" whether they are surgeons, physiatrists, pain specialists, chiropractors, etc. will acknowledge that they know patients who have done well with surgery (fusions). Artificial disc replacement results will likely parallel the results of fusion. Those who did well with a fusion would also likely have done well with a disc replacement. THE PROBLEM WITH FAIR AND POOR OUTCOMES IS NOT WITH THE PROCEDURE, BUT WITH THE INDICATIONS AND PATIENT SELECTION. LIMITATION OF THE COVERAGE, AND THUS THE AVAILABILITY, OF A PROCEDURE (DISC REPLACEMENT) DOES NOT SOLVE THE PROBLEM OF FAIR AND POOR OUTCOMES; IT ONLY LIMITS THE AVAILABILITY OF THE PROCEDURE TO THOSE WHO MIGHT BENEFIT FROM IT. Those poorly selected patients will likely still be offered surgerical intervention in the form of a fusion by someone, and unfortunately get it. While there are added risks unique to disc replacement over fusion such as dislodgement, wear, and few revision options, there remains a significant POTENTIAL benefit of disc replacement over a fusion in that load sharing and motion preservation MIGHT slow or prevent adjacent level degeneration. If fusions are covered, and thus available, as a treatment option for low back pain believed to be secondary to disc degeneration, then artificial disc replacement should also be covered, and thus available as a treatment option. Restriction of trade issues aside, an alternative would be continued access to those with the FDA trial experience with long-term follow-up. Nonetheless, a system to track all of these patients should be instituted to ensure systematic problems do not occur over the next several years and decades.

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I am a neurosurgeon, with an orthopedic spine fellowship training, and have been in practice for 16 years in Portland, Oregon. I've been involved with complex spine problem management extensively throughout these years, including all aspects of spine surgery. Regarding the Artificial Disc replacement, as with all new technologies, it is important to proceed cautiously, and avoid the "bandwagon" rush to start using anything new.

However, I strongly believe there is a subset of patients that may be better served by artificial disc technology for their respective situation. We are living longer, and the concept of "Dynamic Stabilization" potentially helps prevent the acceleration of degenerative change that occurs with traditional fusion, that is a common sequelae requiring more surgery. Therefore, I think it is wrong to uniformly deny this technology option to patients. The real challenge is more with determining indications, that subset of patients who may benefit and proper surgical technique.

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Dear CMS, please don't restrict access to such new and innovative (and well researched/founded/tested) technologies as Artificial/Total disk replacement for the cervical or lumbar spine. As a practicing surgeon for 9 years, i am already seeing failure of Disks and joints above my own fusions done as little as 3-4 years ago. As an engineer in my previous life, the ablility to maintain motion at a "vertebral motion segment" just makes practical sense. More and more data is coming out that bears this out in the lab and clinical applications, including the 5 year followup on the USA FDA clearance trial for the Charite Disk. PLEASE don't make a purely financial dcision, even though the Charite and others like it will MORE than "pay off" in the short term with decreased morbidity. thanks

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I am an employee of DePuy Spine, Inc., maker of the CHARITE(tm) Artificial Disc. My comment is not directed or influenced by my employer, it is my personal opinion.

I appreciate the concerns CMS has regarding the payment of claims for the use of CHARITE(tm)Artificial Disc. It has been noted that this device is not indicated for use in patients over the age of 60 years and the vast majority of patients within the scope of CMS's concern are older than 60 years.

CMS also has concern with a smaller number of patients less than 60 years of age. Many of whom are disabled by low back pain and the judicious use of CHARITE(tm) Artificial Disc within this younger, disabled population is appropriate (as has been determined by the FDA). A significant number of this younger, disabled population would, in fact, become able-bodied again after receiving treatment that included CHARITE(tm) Artificial Disc. It seems unfair, and economically short-sighted, to deny these otherwise able-bodied citizens the opportunity to return to their active lives of work, family and leisure.

CMS needs to be reminded that they set the standard for most private insurance payors. By denying payment for this device, CMS is, unwittingly I sure, usurping the careful and exhaustive regulatory function of the FDA and denying access to a medical device which can restore function and reduce, or alleviate, disabling pain even to those who are not part of a CMS benefit plan.

I urge CMS to reconsider its decision regarding the CHARITE(tm) Artificial Disc.

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I would like to echo the comments of Dr. Herkowitz. Although it is true, and I agree, that the initial FDA studies have their flaws, it would be fair of the CMS to offer this NCD at this time.

Individual surgeons need to have access to this technology to be able to offer their individual patients an alternative to fusion, if this is a reasonable option.

Do I currently intend to begin placing TDRs in elderly patients? Of course not. Dr. Deyo's comments are quite accurate regarding this. However, I have a number of patients who are SSI and Medicare that are in their 40's. Certainly one of the patients may be a reasonable candidate. Or someone with Tricare, etc.

My point is that government payors provide coverage for 50% of people in the United States. By taking this NCD step, it will greatly negatively impact the availablity of this technology not just for the Medicare Elderly (who really aren't going to be receiveing these devices anyway) but the rest of the patients in the U.S., given the ripple effect that other NGO payors are sure to follow.

If there is any other way I may be of assistance, please contact me.

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I am amazed that the CMS has proposed to deny payment for an FDA approved device such as the artificial lumbar disc replacement. As your memo states low back pain is common and can be a disabling condition. Quite frankly, evidence based data analysis concludes no conclusion on effective treatment for back pain. It makes no logical sense for CMS to deny the most exciting treatment option for appropriately selected patients when CMS covers other treatment options including medications, physical therapy, spinal injections and spinal fusion for back pain with no better evidence of efficacy. In fact, it is exactly this conundrum that demands coverage for the artificial disc for now. I am a Board Certified Neurosurgeon with special experience in spinal surgery and I can supply many patients who have benefited from spinal fusion for there back pain. Clearly, every patient that received a spinal fusion is NOT an appropriate candidate for the artificial disc, but equally clearly there are patients that can benefit from a motion preserving device stabilization as opposed to a spinal fusion. Ironically, the artificial disc replaecement has the potential to alter the present state of long term outcomes that often lead to multiple surgeries and chronic permanent disability. If this turns out to be the case, the CMS will actually save a staggering amount of money. The present state of affairs are expensive with many poor outcomes. A change with promise should be embraced. Also, from a cost stand point a fusion operation with cages, infuse and spinal instrumentation is about the same cost as the artificial disc replacement.

When all is said and done, non-medicare patients will receive the artificial lumbar disc replacement and in my opinion will show a distinct improvement over the medicare population receiving spinal fusion. I can only see a public resentment of this withholding of medical treatment in the United States of America.

Again, does the FDA mean anything? If not, get rid of it. If yes, support its decisions.

Sincerely,

Donald D. Dietze, M.D.
Assistant Clinical Professor of Neurological Surgery at Tulane
University in New Orleans, LA

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To Whom it May Concern,

I have several concerns about the proposed ruling that you have laid out. First, you have a proposed non-coverage decision for the Medicare population when your proposal openly states "there is a lack of sufficient data." How can CMS propose a non coverage when there is, admittedly, not enough data. The non-coverage should be reserved for areas when there is data that shows a significant concern in the patient popluation. Clearly that is not the case here so the non-coverage decision is premature.

Second, the data that does exist is promising. There is one Level 1 data set, the Charite IDE study. Even the most critical eye shows that the technology is promising. The case reports that you site as concerns such as Van Oij should NOT overule the one piece of Level 1 data that is available. Based on this your ruling should be a limited coverage of a coverage with evidence development.

Finally, the technology and field of Arthroplasty is encouraging. The coverage decision should be positive and encompass all technologies so that we can gather more clinical experience with the appropriate patients, especially considering that the major concern you point to is insufficient data.

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Dr. Polly presented a meta-analysis of recent class I randomized controlled trials supporting the efficacy of surical treatment of degenerative disc disease using both quality of life and cost parameters (North American Spine Society 2005). His analysis makes the Cochrane review look quite poorly done. The Cochrane review used old studies and painted with very broad strokes on "spondylosis" instead of a more focused analysis of degenrative disk disease.

While I agree that the Charite may not be indicated for the over age 65 population, I am concerned that your decision will afect younger (disabled) patients on medicare and may also incorrectly influence other insurance carriers.

MR

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I have been implanting the Charite` Artificial Disc for 5 years. I have implanted about 40 of these devices. In carefully selected patients, this device has an excellent 5 year track record in my hands. I have had no device failures, no dislocations and exemplary patient outcomes. In addition, my patients have returned to work and their normal activities of daily living far quicker than my demographically matched fusion patients. In addition, these patients have a shorter length of hospital stay. I would be glad to refer you to a number of my patients to speak to them personally.

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after reviewing both dr. deyo's letter as well as all of the comments posted prior to today, I am discouraged that what appears to be a very efficacious procedure may continue to be denied, not only to appropriate medicare beneficiaries but also to myriad other deserving and disabled individuals who are covered under private insurance programs, should the proposed negative ncd bocome policy. rather than repeat all of the pro-arthroplasty statements already enterred into the record, please assume that my point of view is that of all of the others who have already written in support of disc arthroplasty.

although i can not disagree with dr. deyo with regard to the majority of medicare beneficiaries, who are not disc arthroplasty candidates based on age, bone density, levels of involvement, etc., there clearly are other, far younger and healthier medicare beneficiaries who meet criteria for disc arthroplasty. To deny this surgical treatment option to these individuals, solely based on their being included in the medicare population, is not only unfair but also inappropriate. I believe that there are disabled individuals whom, when treated with disc arthroplasty, will no longer be considered as disabled, will be able to return to a more productive lifestyle, and will be able to once again contribute to not only their own welfare but to that of others in their families and their communities. In my experience, treating this type of individual in the traditional manner (i.e. arthrodesis) results in an extension of the disability rather than a more rapid return to being active. Although arthrodesis may alleviate symptoms in these individuals, it may not allow them to return to work, which has not been my experience with disc arthroplasty.

i am hopeful that the proposed non-coverage determination will not be finalized; disc arthroplasty in the appropriate patient is a far better treatment than any available at present, and should not be denied in a blanket fashion. the additional supportive data requested in the negative reviews of disc arthroplasty will only become available as larger patient groups are studied; the proposed ncd will result in smaller numbers of individuals being available for study, and will further inhibit disc arthroplasty research.

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I am a Spine Surgeon with a busy clinical practice and am well versed in the literature pertaining to both Lumbar fusion and the Charite Disc.I have read Dr. Deyo's recommendations for a CMS noncoverage decision for the Charite Disc Replacement. In many regards I feel that his concerns and views are appropriate and reasonable. However, I want to share concerns about his recomendations.

Dr. Deyo has strong, justifiable concerns about the overuse of spinal surgery in general and specifically spinal fusion. I agree with his basic premise that spinal fusion is an overutilized treatment. However, it is a well founded and appropriate treatment that is very effective in selected cases. A non-coverage decision by CMS for spinal fusion would certainly curtail the overuse of spinal fusion in the CMS population. However, it would also prohibit the use of spinal fusion for patients in whom it is the most appropriate, and effective treatment, condemning these patients to a miserable existence when an effective treatment is available.

I know that we are discussing the Charite Disc and not Spinal fusion, but the same reasoning applies to the Charite Disc. The differences that Dr. Deyo points out are real and significant, that is that it is untested in patients over the age of 60, and that long term studies of it's effects are not avalilable and that there are some significant concerns about it's long term safety and effectiveness. However, there are also similar concerns about spinal fusion operations that remain as the only other option currently available for selected problems.

To address the most significant concerns:

1) Loosening or Wear and failure of the implant due to long term stresses - In other joint arthroplasty models such as hip and knee these issues are actually much more significant in the younger age population that tends to be more active and thus put exponentially greater stresses on the implant and interface. Older, less active patients tend to have fewer problems with wear and loosening.

2) Migration of the implant- these can be expected to arise from initial malposition and in the case of osteoporotic bone in which there is bony failure. There are strict recommendations by the Depuy company which specifically address these issues, and they have been very careful to provide excellent training to assure education and experience to prevent initial malpositioning, and strong recommendations about avoiding it's use in the presence of osteoporosis. Despite these precautions there are still cases in which migration and revision or removal procedures will be necessary. The FDA's approval of the device would seem to indicate that they felt the incidence of these problems was of sufficiently low level to warrant approval.

3) Migration due to loosening and wear would theoretically be more of a problem long-term in younger, more active patients than in the typical CMS patients.

4) Migration and failure due to bone quality issues (osteoporosis) should theoretically be avoided if very strict adherence to protocol were mandatory in regards to Osteoporosis testing preoperatively, and are not strictly related to age. Many older patients have excellent bone quality, wheras many younger patients are already osteoporotic.

Another concern is the fact that CMS regulations may effect not just patients over the age of 60 ("medicare age") but also patients whose insurance coverage is Medicaid, and other Federal Insurance programs. Also that CMS non-coverage decisions tend to be followed by the general commercial insurance industry whether or not they are logically applicable to their population as it is financially in their interest to do so.

The issue of the extrodinary cost of this technology, particularly for a condition that is so common in the medicare population and the population in general is obviously of great concern. However, CMS and the Hospital and physician community is facing a similar problem in many areas of medicine. Unfortunately CMS and society in general are not making any attempt to openly discuss or tackle this problem, which vastly overwhelms the problems of the CHARITE DISC. If CMS does not tackle the bigger issues of the exploding costs of our advanced medical technology, and whether we can really afford to spend hundreds of thousands of dollars on every patient with any routine medical problem, the system is going to explode. When physicians are forced to follow the "standard of care", for fear of malpractice, when the cost of such care is clearly outrageous, there is little hope for controlling the costs.

Sorry about the diatribe. Good luck in making an appropriate decison and I would be willing to discuss the larger issue with CMS at any time.

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While the age of the average medicare patient is often above the age where this device is recommended (though not necessarily so), the real implication for this decision is that a negative decision will be used as an excuse for private health ins. companies to deny coverage for the people who benefit the most from this device, the 20- and 30-somethings with single level degenerative disk disease. Thus their only real surgical option will be the first in (almost certainly) a series of fusions. That is not what I would want for myself (if I were still that young) or my family member. I strongly recommend approval for the medicare population, just with very narrow guidelines, such that it will be an (appropriately) uncommon procedure for the medicare group, and yet not relegate the rest of the US population to care that is not only clearly less than ideal, but also behind other parts of the world.

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I understand that the CMS is considering placing the lumbar total disk arthroplasty onto a list of non-coverage. As a spine surgeon, I wanted to write and state my objection to this decision. Generally speaking, I am not a surgeon who includes back pain as an indication for surgery. Furthermore, back pain surgery is rarely indicated in the average Medicare patient. There are a subset of individuals who have Medicare coverage who might benefit from lumbar arthroplasty. This group would include the younger patient whom has been deemed disabled and is covered by Medicare and the physiologically young 65 or so individual who has just been placed on the Medicare roles.

I understand that these are tough financial times for Medicare. I also understand that the prospect for a much higher number of individuals from the 'Baby Boomer'generation with further stress the system. Having said that, I hope that this decision will be carefully considered and that a decision can be made in the best interest of the patients and not based entirely on financial concerns.
Sincerely,
David Wimberley MD

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Reimbursement for artificial disc replacement should be considered strongly. The alternative to this is simply fusion of two vertebral segments, not restoration of the diseased segment. This alternative is not ideal because it is changing one abnormal condition(diseased disc) for another abnormal condition (fused segment). Without reimbursement, economics will drive the surgical solutions toward fusion, impede progress in the development of this new technology, and, ultimately, not able to achieve the ideal goal of restoration to pre-diseased conditions.

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As a spinal surgeon well familier with both anterior and posterior approaches and as a graduate of the Charite training program. I find the indications for this procedure very limited. In particular, the procedure is not indicated in the elderly medicare population. In younger individuals on medicare, the vast number of patient's I am familier with in this catagory have one or more contra-indications to disc replacement and thus I find that the denial of disc replacement surgery to the group of patients insured by medicare is not likely, in all medical probability, to represent even a minor constriction in surgeon decision making abilites nor a significant denial of patient care.

wcw

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I have been trained in total disk replacement surgery and have implanted this device in my patients. This is a tremendous advancement of spine technology that gives spine surgeons a motion sparing option for our patients. I have had an excellent experience with Artificial Disc Replacement and consider the CMS decision a major step back in the advancement of modern medicine. The data is well documented with regard to safety and results. The data is very similar to single level lumbar fusion. However, there are specific circumstances where a motion preserving option is by far the best choice for the patient, and this option should be available to the surgeon. I am extremely disappointed in this decision and would respectfully request reconsideration. In my experience, the primary critics of this new techology usually have dubious motives or are poorly informed and are not forward thinking type individuals. This technology is akin to the development of peripheral joint arthroplasty in decades past...Knee and hip fusion definately relieved pain, but obviously, the development of motion preservation devices was by far the best option and is now the gold standard...joint replacement also had their critics as well, but look how foolish this was. Many similarities exsist with disk arthroplasty...please reconsider. Thank you.

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As lead investigator for the Charite IDE and the largest clinical site in the US, I would like to comment and strongly protest a potential non-coverage decision. We now have data past 5 years that continue to support the safety and efficacy proven in the trial. While I would agree that this technology has limited use in the over 65 Medicare population, the indications for the 60 and under age group I believe are quite sound. As a viable alternative to fusion and a safety profile comparable to established anterior fusion techniques a negative coverage decision could potentially deprive the public of this promising technology. This would not be limited to the under 65 Medicare population alone but could be used by private carriers as an excuse to deny coverage to this FDA-approved device.

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I have implanted approximately 10 Charite patients, age ranging from 26 to 45. One of these patients was in her early 40's and she was disabled, on medicare. She did quite well.

It is my personal belief that the CMS determination is wrong because although the majority of the medicare patients would not be candidates for an artificial disc because of age and medical condition, the determination would:

1. Preclude the 10 - 15% of patients who are under medicare because of disability and are under 50. They may be legitimate candidates.
2. Preclude legitimate candidates under other health plans who will deny authorization using the CMS determination as a blanket statement of non-coverage.

The determination is another blatant attempt at removing the autonomy of Physicians. It essentially implies that surgeons do not know the indications for athroplasty and that we can not be trusted to do so.

It is interesting to note that the public statements that are in favor of non-coverage are insurance plans and non-surgical MD's who are perhaps serving their best interests. People who really care, the patients themselves and the surgeons who have to somehow improve a truly horrible condition, do not support the CMS determination.

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I have been working with the Charite aftificial disc for years. I am a practicing neurosurgeon in New Bedford, Massachussetts. In the same period of time I have also performed a number of lumbar spinal fusions.

There is no comparison between the two procedures. In the appropriate patient, the hospital recovery, return to full activity, postoperative pain, and overall outcome of artifical disc is much much better than spinal fusion.

I still find it hard to believe that after all the trials, health insurance providers, and CMS do not cover the artificial disc. Be covering the artificial disc, CMS would be SAVING MONEY. Shorter hospital stay, less rehabilitation, fewer medications, and faster return to work. It seems like easy decision to make.

Thank you very much
Alvin Marcovici

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BlueCross BlueShield of Tennessee supports the CMS proposal that the evidence is not adequate to conclude that lumbar artificial disc replacement with the Charite artificial disc is reasonable and necessary. We wish to submit comments from two well respected medical technology assessment sources that further support your findings on this topic. Of note, neither of the two assessment centers located information on whether or not the prosthetic intervertebral disc affects adjacent discs or information regarding long-term durability of the prosthetic intervertebral disc itself. Available studies are insufficient to recommend coverage for this technology.

The Technology Evaluation Center. (2005, April). Artificial vertebral disc replacement. (Vol. 20, No. 1). Retrieved April 6, 2005 from http://www.bcbs.com/tec/vol20/20_01.html.

Current evidence supporting the effectiveness of artificial vertebral disc is insufficient. Case series evidence is inadequate to establish efficacy. There is only one completed randomized, clinical trial that evaluates the Charité artificial disc compared to BAK fusion cage. No other disc replacements have better or more rigorous evidence of efficacy.

The only randomized, controlled trial has several methodologic issues that make it difficult to interpret the results. The Charité artificial disc had a success rate of 63%, compared to a success rate of 53% for BAK fusion, using a composite measure of outcome that incorporated improvement of symptoms and absence of complications. The first concern is that the analysis showed noninferiority compared to BAK fusion using the composite measure of success, but did not show statistically significant superiority in most outcome measures. A noninferiority trial design implies that there is a trade-off between efficacy outcomes and some other advantage of a new technology, for example, morbidity or invasiveness, such that a less-stringent threshold for efficacy is acceptable. However, at this time, no such advantage has been demonstrated for the Charité artificial disc. So the reported success rate shows that the artificial disc is not inferior to the BAK procedure, not that it is better.

The second concern is that the lack of a prespecified analysis plan, unexplained closure of the database before all patients reached completion, and lack of intent-to-treat analysis may cast some doubt on the analysis. Although the sponsor provided TEC with additional analysis that included patients that were excluded from the analysis presented to the FDA, it was unclear how many additional patients actually provided 24-month outcome data and what imputation was performed for missing or discontinued data.Finally, although fusion is considered a standard surgical treatment for back pain due to DDD, doubts remain about its effectiveness, as clinical trials comparing fusion to nonsurgical alternatives show conflicting results. Moreover, substantial variation in frequency, success, reoperations, and complications has recently been reported for spinal fusion procedures. The use of the BAK procedure as a comparator to the Charité disc highlights the problem, as no randomized, controlled trials exist comparing the BAK to other spinal fusion techniques or to conservative management. Given the broader clinical context, and the concerns with the sole randomized, controlled trial, the evidence is not sufficient to conclude that the use of artificial vertebral disc improves health outcomes. Low back pain is a common condition. Given the population affected, additional and more rigorous trials of the outcomes of the use of artificial disc in the treatment of DDD are needed.

Health Technology Assessment Information Service. TARGET database. (2004, March). Artificial intervertebral disc replacement for degenerative disc disease. Retrieved March 1, 2005 from ECRI HTAIS. “…only limited evidence is available on the safety and efficacy of the procedure for treating DDD, which prevents drawing firm conclusions about efficacy at this time. Study designs are weak and examine different implants, dissimilar generations of the same implant, varying surgical techniques, mixed patient populations, and lack of long-term (more than two years) follow-up.”

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Evidence for Superiority of Charite TDR versus Lumbar Fusion

There are four areas of evidence that show superiority of Charite TDR versus Lumbar Fusion—1) Primary Outcomes Success on Level 1 FDA prospective randomized study (at every follow up interval); 2) Safety ; 3) Lower Reoperation Rate at Index Level; and 4) Lower Reoperation Rate at Adjacent Level compared to fusion.

1. The highest form of research is prospective RCT’s and Meta analyses derived from them— Level I studies. Two are published already reporting the results of the US FDA study of the Charité artificial disc, Part I (3) is the clinical outcomes and Part II (4) is the radiographic analysis. A common criticism is that the study required “Training Cases” as the surgeon investigators were experienced “fusion surgeons” but by necessity did not have as much technical expertise with lumbar TDR. Geisler et al (5) have completed another Level I analysis, “Alternative Statistical Testing Demonstrates Superiority of Lumbar Arthroplasty Clinical Outcomes at 2 Years vs. Fusion for the Treatment of One-Level Degenerative Disc Disease”. With the “training cases” added the conclusions of the new analysis using the Wilcoxin Rank Sum Test are even more convincing—Significantly Superior Clinical Outcomes at all time intervals through 2 year follow up. The Charité Five Year Follow Up Study is underway with some of the patients approaching 6 years in March—the superiority of TDR over Fusions remains. With the “approvability” FDA letter for ProDisc-L taken in combination with the data presented at NASS by Delemater et al (6), it is expected that another Level I study has shown favorable results for lumbar arthroplasty in comparison to an alternative Fusion Control Group, 360 degree arthrodesis.

2. SAFETY. The most comprehensive review of complications for TDR is a CME approved roundtable discussion by internationally experienced spinal surgeons (7), “Roundtables in Spine Surgery. Complications and Revision Strategies in Lumbar Spine Arthroplasty”, a 213 page monograph available through Quality Medical Publishing. Since it’s release at NASS 2005, there have been 6500 copies distributed. So surgeons are interested in the safe adoption of this new technology (8). In fact the majority of the 2,800 surgeons who have attended the Cincinnati Charité Training Courses have actually not performed a procedure yet. Furthermore, DePuy Spine has compared the complication rates from Medical Device Reports (MDR’s) required for FDA surveillance on the first 4000 Charité procedures in the first year after FDA release they are actually lower than the incidence in the FDA randomized portion of the trial. An independent CRO has also monitored the 4000 cases and this also documents a responsible adoption of lumbar arthroplasty—NOT a repeat of the “cage rage.”

3. In the Charite IDE from the randomized study of 375 to 688 (CA1 + CA2 )patients the reoperation rate went from 4.9 % up to 8.1% (Compared to 12.1 % for Fusion Control). This is what happens when second, third, and fourth co-investigators at the same site become involved in any procedure as it evolves through the Continued Access portion of an FDA study. The secondary investigators and access surgeons simply haven’t spent the time visiting experienced surgeons overseas, attending cadaver labs, and the CA portion of the study tends to be the phase of the study when the company tries out modifications in the instrumentation, in preparation for the eventual widespread approval.

For a Level I Study reference point for the 4.9 and 8.1% numbers above, we can use one of the least reproduced and least publicized facts in the Spine Literature (9)—it is the reoperation rate of the INFUSE FDA study, which is directly from the Summary of Safety and Effectiveness FDA report ( PMA number P000058) (page 9 of 40)—“The number of subjects requiring a second surgical intervention was 10.4 % (30/288) in the investigational group (Infuse/LT) and 13.7 % (19/139) in the Control group. The majority were supplemental fixation due to painful non-union.” This is a great revelation to most spinal surgeons who criticize the Charite FDA study and the ProDisc-L study because they did not use the Gold Standard, BMP. Unfortunately BMP was not FDA approved in time for either lumbar arthroplasty to use as a Control Group—but 10.4 % is still a higher reoperation rate than 4.9 % at comparable two year follow up or even 8.1 % at up to 5 year Charite follow up. What about clinical outcomes – look at page 37 of 40—“For a future patient receiving the Infuse/LT via open anterior surgical approach the chance (the predictive probability) of overall success at 24 months would be 57.1 %... whereas the Control Treatment (Same Control as Charité, interbody fusion cage and iliac bone graft) was 56.7 %. Where’s the Superiority here? 57.1 % versus 56.7%.

4. Lumbar TDR FDA studies are done on a very challenging population patients disabled for a minimum of 6 months, many for over two years and minimum ODI of 30 or 40. What happens if you study the same technology, same biomaterials, same bearing surfaces, same ingrowth surfaces, in a purer population with a more objective indication like presenting with a neurological deficit? Essentially this is cervical arthroplasty. Anderson et al (10) showed a higher reoperation rate, 2.59 %(15/580) at the adjacent level in the Fusion Control Group versus 0.77 % (5/649) reoperation rate at the adjacent level in Cervical Arthroplasty (p < 0.05).This is the first study in the world’s literature showing a lower incidence of adjacent segment disease with arthroplasty but it required a sample size of over 1000 patients.

For the Charite the four highest enrolling FDA IDE sites (Baltimore, Dallas, LA, and Chicago) combined their most up to date follow up data from the 5-Year Charite Study (Reference 11). A total of 359 patients were enrolled at the four sites, yielding 52.1% of the total cohort. Of these patients, 305 (51.8%) received total disc replacement (TDR) and 54 (54.5%) received the control. The mean follow-up was 25.4 months (1-68 mos). In the TDR group 14 (4.6%) required reoperation while 7 (13.0%) required reoperation in the fusion group. The Kaplan-Meier analysis predicted a significant difference in survivorship in the TDR group (92.4%), compared to the fusion group (80.1%) at 5 years (p=0.0030). The rate of adjacent-level disease requiring reoperation was significantly less in the Charité group (2/305, 0.6%) compared to the fusion group (3/54, 5.6%) (p=0.0259).

The science (Level I prospective IDE’s) already show superiority of TDR’s versus Fusion. Still to come is the Maverick IDE (metal-on-metal), the Charité 5 Year Follow Up Study, and Survivorship Analysis proving durability at longer term follow up for TDR. It is reasonable to have healthy skepticism and move cautiously to adopt the new technology of Motion Preservation. But it is not advisible for an economic group applicable to patients over age 65 to render an opinion on a Product and technology with PUBLISHED INCLUSION CRITERIA AGES 18 to 60 ONLY.

It is not scientifically valid for CMS to criticize European studies performed in capturing 5 to 10 year follow up outcomes the ODI, VAS, SF-36,Odoms, and other recommneded clinical outcome measures had not been validated at the time David, LeMaire, Ross, Buttner-Janz, and Zeegers performed the Charite Procedures in the late 1980's and 1990's Of course they could not use modern clinical outcome measures. Their valuble "case studies" are consistent with the scientific standards at the time of the patient's surgical procedures.

REFERENCES

1. van Ooij A, Oner FC, Verbout AJ. Complications of artificial disc replacement: a report of 27 patients with the SB Charite disc. J Spinal Disord Tech 2003;16:369-83.

2. Putzier, M, Funk, JF; Schneider, SV: Charité Total Disk replacement – Clinical and radiographic results after an average follow up of 17 years. Eur. Spine J. 6: 586-591, 2005.

3. Blumenthal SL, McAfee PC, Guyer RD, et al. A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement with the CHARITÉ™ Artificial Disc Versus Lumbar Fusion Part I: Evaluation of Clinical Outcomes. Spine 2005;30(14):1565-75.

4. McAfee PC, Cunningham B, Holsapple GA, et al. A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement with the CHARITÉ™ Artificial Disc Versus Lumbar Fusion Part II: Evaluation of Radiographic Outcomes and Correlation of Surgical Technique Accuracy with Clinical Outcomes. Spine 2005;30:1576-83.

5. Geisler, FH; Blumenthal, SL; Guyer, RD: Alternative Statistical Testing Demonstrates Superiority of Lumbar Arthroplasty at 2 Years vs. Fusion for the Treatment of One-Level Lumbar Degenerative Disc Disease at L4-5 or L5-S1. Spine 2006; 31: (in Press)

6. Delemarter, RD; Zigler, J: Ohnmeiss, D: Lumbar Total Disc Replacement: a 2 to 3 year report from 2 centers in the US Clinical trial for Prodisc-II prosthesis. The Spine Journal 5: 157 S- 158 S, 2005.

7. McAfee PC, Geisler FH, Scott-Young M; eds. Roundtables in Spine Surgery: Complications and Revision Strategies in Lumbar Spine Arthroplasty , Pub. St. Louis: Quality Medical Publishing, 2005.

8. McAfee, PC; Geisler, FH; Saiedy, SS: Revisability of the CHARITE™ Artificial Disc Replacement—Analysis of 688 Patients Enrolled in the US IDE Study of the CHARITÉ™ Artificial Disc , Spine 2006: 31 (in Press).

9. ”Summary of Safety and Effectiveness Data” Infuse bone graft/LT Cage Lumbar Tapered Fusion Device, Premarket Approval Application (PMA) number, P000058, Approved July 2, 2002. www.fda.gov/cdrh/pdf/p000058b.doc

10. Anderson, PS; Sasso, RC; Metcalf, N: Reoperation Rates for Cervical Arthroplasty versus Arthrodesis. Presented at the Annual Meeeting of the Cervical Spine Research Society, December 1, 2005, San Diego, California. Paper # 2.

11. McAfee, PC; Geisler, FH; Blumenthal, SB; Guyer, RD; Regan, JJ; Stadlan, N; Dabbah, M; Siddiqi,F; Hayes, VH; and Ohnmeiss, D: Predicted 5-year Survivorship of the CHARITÉ Artificial Disc vs. Anterior Lumbar Interbody Fusion: A Kaplan-Meier Analysis, IMAST and Scoliosis Research Society Meeting 2006.

By Paul C. McAfee, MD
Chief of Spinal Reconstructive Surgery
t Josephs Hospital
Baltimore, Maryland

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I am confounded and dissappointed with the CMS provisional recommendation regarding lumbar artificial disc replacement. The medical profession and industry have worked diligently and with only the best intentions of the patient to responsibly evaluate and introduce a superior treatment alternative for carefully selected patients. The FDA has approved now two such devices for use in the United States. To have CMS and certain thrid party payors attempt to build substantial roadblocks and hurdles or even complete dead end streets for the consuming public and for the providers is enormously unfair. I believe the recommendation must be reconsidered.

The lumbar artificial disc is not only non-inferior with regards to patient outcome, reduction in percieved pain and patient satisfaction as compared to fusion, but what is less understood by those that would be nay sayers is that lumbar disc replacement is superior to fusion in several arenas. It leads to a faster return to work, it is less costly (all things considered), it requires no bone grafting or bracing thereby reducing patient pain and inconvience and it does not unnaturally stiffen the spine.

Additionally, I have always had grave concern that I not worsen the potential for adjacent segment degeneration with our fusions done in the past. It is a undeniable aspect of doing fusions in my opinion, however, particularly long fusions. To be able to eliminate this effect for one level fusions is very attractive. You should not take this away for us as providers and patients.

Lastly, I believe that state funds, workmans compensation and industrial boards will have less long term liability and treatment costs associated with adjacent segment disease when their covered lives, when appropriate, are treated with motion sparing techniques. In their absence, they are burdened with the responsibility of caring for a lifelime of adjacent segment degenerative conditions when fusions are employed. This could be a hugh cost savings for this part of our health care costs that employers must bear.

Please reconsider your recommendation. It is ill-advised.

Sincerely,

Gregory S. McDowell MD
Orthopedic Surgeons and Sports Medicine
Co-founder of the Northern Rockies Spinal Injury Program
Regional Board Member of St. Vincents Hospital
and Health Care System
Board Member Rocky Mountain Health Network
Billings MT
sixnmt@aol.com

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The TDR is a revolutionary implant that could bring pain relief to a group of patients that are desperate for help. All conventional treatment methods have failed in these patietns. These patients are left with ineffective costly pain management programs, instead of having the option to undergo a definitive treatment which could make them productive members of society again. To withhold this treatment option form this selected group of patients would be as CRUEL as refusing new generation antibiotics for chronic infections... leading to a permanent state of chronic impairment wich is a life altering event for these patients.

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Dear CMS

The Spine surgeons of America have worked extremely hard to prove our research, That artificial disc replacement is a proven safe effective manner to treat discogenic low back pain (Mcafee spine 03). The procedure has low complication rates and a decreased hospital length of stay. This saves money with rising hospital cost. In addition alot of American workers are not working because of discogenic low back pain. This increases the cost of workers compensation for struggling American companies. Help us to get the people back to work to control workers compensation cost by approving reimbursement for the Artificial disc.

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The total disc replacement is an important new technology that has passed a rigorous FDA trial. The clinical results are significantly better at each evaluation period over the two years follow-up. In my opinion, it is not appropriate to compare the FDA trial to less rigorous retrospective trials from the past. This technology should be approved for use by CMS or decide to continue clinical review for another period of time. The total disc technology is our future and should not be censured by a governmental agency.

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Advocacy for Patients with Chronic Illness, Inc. opposes issuance of a national coverage decision for three main reasons.

First, there may be a patient who, if evaluated on her individual circumstances, ought to have access to Charite artificial disc replacement. These decisions must be made on a case-by-case basis.

Second, a Medicare noncoverage determination will echo in the world of commercial insurance, so your decision will affect more patients than you intend. For that reason, you should be especially reluctant to issue a decision that may make this device unavailable to any and all patients who cannot afford to pay for it themselves.

Third, you cite to public comments addressing the limited need for this device in the elderly population, but that ignores the population who are on Social Security disability and are eligible for Medicare as a result. This device might render one or more of those patients able to work and stop receiving Social Security disability.

Advocacy for Patients has two pending commercial health insurance appeals dealing with the Charite artificial disc. Based on the medical records submitted by these patients, we contend that Charite is their only remaining option to avoid disabling pain and/or a lifetime of narcotic addiction. We contend that it would be best to allow those patients to have an individualized medical necessity determination, whether they were Medicare eligible or private pay, so that the merits of their cases can be evaluated based on the specifics of the case. Your proposed decision would foreclose such an option.

Advocacy for Patients is a tax exempt, 501(c)(3) organization representing patients with chronic illnesses, including chronic pain. As part of our work, we conduct many trainings for medical offices on how to conduct health insurance prior authorizations and appeals. It is appropriate for us to disclose here that we have submitted a proposal to the manufacturer of Charite offering to provide trainings to medical offices to assist them to present their cases in favor of coverage of Charite to insurers. However, at all times, our clients are the patients. When we train medical offices, it is because that is one of the most direct and efficient ways of reaching large numbers of patients. To date, we have received no compensation whatsoever from the manufacturer of Charite, nor are we certain that we ever will. We simply disclose the fact that we have submitted this proposal so as to avoid any appearance of impropriety. Advocacy for Patients does not accept any compensation from any source when it advocates on behalf of a patient, whether in the health insurance context or otherwise, even when payment is offered.

In sum, we strongly believe that patients with chronic illnesses, including chronic pain especially patients on Social Security disability who are eligible for Medicare must have access to every available weapon in the arsenal in order to combat their condition. Medicare should leave open the possibility that Charite will be better for some patients than a lifetime on narcotic pain medications and disability. We strongly urge against issuance of this NCD.

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