View Public Comments for Lumbar Artificial Disc Replacement

The North American Spine Society (NASS) is the leading multidisciplinary medical society advancing quality spine care through education, research, and advocacy. NASS membership comprises 21 specialties providing spine care including: orthopedic surgeons, neurosurgeons, physiatrists, neurologists, radiologists, anesthesiologists and other spine care specialists. Our unique membership provides us with a vast base of expertise and is particularly beneficial in responding to issues relating to new technology. We appreciate the opportunity to review and comment upon the National Coverage Decision (NCD) for lumbar artificial disc replacement.

The field of spine care has experienced marked growth and development during the past decade. New methods of non operative care, new diagnostic capabilities and new techniques in surgery are being developed at an ever increasing pace. The vigorous assessment of new technology using evidenced based research is critical to assure efficacy and safety of new procedures. In addition the assessment of new technology must also include study of the magnitude of the health effect and a cost benefit analysis to help plan the spending of increasingly scarce health care dollars.

CMS has opened an NCD request to review the coverage of the lumbar artificial intervertebral disc made by Dr. Richard Deyo on August 5, 2005. In his letter, Dr. Deyo correctly points out there have not been any published studies assessing the utilization of TDA in the elderly population. We share this same concern and have raised it to both CMS and AMA-CPT in public statements. Dr. Deyo’s concerns regarding implantation of TDA in osteoporotic patients and the relatively short follow-up in American based studies are also logical. It is appropriate to point out, however, that osteoporosis and osteopenia are direct contraindications for this device as per the FDA labeling. Dr. Deyo also states that he is “worried about the misuse of Charite until better data is available”. NASS also is equally concerned about patient safety and steadfastly supports proper implementation of the Charite device as well as any other emerging technology It is for this reason that our recommendation to CMS is that a national coverage decision should not be made until better data are available. It was the lack of sufficient clinical evidence, particularly in the Medicare population, that led CMS to not approve TDA for new technology Add-on payment. We believe a consistent and logical extension of that determination would be to delay decision on this NCD.

Based on current science and clinical information we simply cannot determine whether or not TDA would be indicated in elderly patients. However, a negative NCD could potentially stop current and future clinical trials and make it extremely difficult to gather relevant data on the efficacy of TDA. It would also encourage other third party payers to deny reimbursement for TDA, thus limiting physicians’ capability to utilize this treatment option in appropriately selected patients, understanding that these patients may experience significant benefit from the device (as the clinical evidence suggests).

As with any emerging technology, it is essential that new data be collected in order to make a rigorous assessment of efficacy. By delaying the NCD and thereby keeping the road open for future data collection, CMS can play a positive role in the development of effective treatment for all patients, including possibly Medicare patients. This is particularly poignant since Medicare coverage is not strictly limited to frail osteoporotic individuals.

In conclusion, we would urge the coverage analysis group to delay any decision on this NCD until sufficient data is available to allow a determination of the usefulness of this technology (and not simply one name brand device) for all Medicare beneficiaries. Finally, we would encourage CMS to avoid being placed in the role of policing medical decision making by way of instituting coverage policy. We respect and fully support the role CMS plays in the provision of high quality, effective health care, not only to Medicare beneficiaries, but to the entire American population. In this case, it is in everyone’s best interest to delay decision and allow more research to be developed and more data to be collected.

Sincerely,

Jean-Jacques Abitbol
President
North American Spine Society

I am a Board Certified Orthopaedic Spine
Surgeon. I have reviewed Dr Deyo's letter, and
have extensive experience with artificial disc
replacement(ADR). While Dr Deyo's point
regarding ADR and osteoporosis is valid,
Osteoporosis is a relative contraindication to
many spinal implants. However, CMS has not
issued a negative NCD on such implants. In
addition ADR does play a smaller role in the over
60 population. However, such factors need to be
evaluated on a case by case basis by the surgeon .
In addition not every medicare patient is over 60.

To issue a NCD would be depriving a subset of
Medicare patients from a useful procedure.
Irrationally rationing healthcare goes against
the basis of what our society has been based on.

I am shocked by Dr. Richard Deyo’s letter of August 5, 2005. The CHARITE-Lumbar Artificial Disc Replacement and the Pro Disc Lumbar Artificial Disc Replacement (of which I was an investigator) were one of the very few studies on any spinal implant or indeed spinal procedure that has been studied in a prospective randomized manner with two year follow up. Not only were the patients blinded but also the surgeons were blinded at the beginning of the study as to which treatment the patient would have at the time of their operation. These studies were performed under strict FDA auspices, and I do not know how they could have been more rigorous.

The majority of studies from Europe are indeed case studies. However, we know that in the majority of cases these prostheses may have a longevity of at least 15 years. The Van Ooij study that Dr. Deyo cites is also a case series of patients who had complication after disc replacement. The claim, “although theoretically appealing especially in younger patients there is currently insufficient data to assess the performance of the intervertebral disc arthroplasty adequately.” is totally unsubstantiated by the manuscript in light of
these studies from the U.S.

Dr. Deyo takes issue with the restoration of spine motion. Of course, this criticism has nothing to do with the pain relief and efficacy of the operation. Finally, in summary, Dr. Deyo quotes The Wall Street Journal. Such a strategy of consulting the popular lay press in a poorly executed article makes absolutely no sense when judging the scientific merit of a particular device. Of course, there are issues that prospective patients may ask of their surgeon but to indicate that an operative procedure should be judged on the basis of what a biased non-medical business reporter writes is truly outlandish and well beneath the dignity of the author and the governing body who should determine the efficacy of any medical intervention.

I am strongly opposed to the request by Dr. Deyo to institute a non coverage policy for all medicare beneficiaries for lumbar spine arthroplasty. I was a Charite` IDE investigator and I have been implanting these devices for 5 years. It is obvious to me from my own cohort of patients as well as the recently published FDA IDE data that if we carefully select our patients and abide by the inclusion/exclusion criteria outlined in the IDE study that spinal athroplasty is a safe and effective means of treating single level DDD in the lower lumbar spine. This robust, prospective 2 year multi center data is an excellent beginning to more fully understanding the long term effects of spinal arthroplasty.

Continued prudent utilization of motion preservation devices and careful data collection will help us answer the questions we currently are asking about this technology. If CMS issues a non coverage policy for lumbar spine arthroplasty, I fear that further advancements in this arena will be severely restricted.

All surgeons who are currently implanting the Charite` disc are very much aware of the indications and contraindications as well as the inclusion/exclusion criteria. This is a result of the mandatory high level training course surgeons receive from DePuy Spine before they begin implanting these devices.

The applicability for the Charite in the elderly
Medicare population is limited. Dr. Deyo's
comments in regards to the contraindications of
osteoporosis and arthritis are correct. However,
there is a large number of individuals who are
disabled by their pain and still could be helped
by surgical intervention. A significant
improvement in function and employability occur
once the pain from a degenerated segment has been
eliminated. A negative decision will affect the
ability to care for these patients as well.

The request by Dr. Deyo is an inappropriate and untimely request for the use of CMS resources to make a national coverage decision. The reasons for this are as follows:

1) There are at least three FDA IDE lumbar disk studies that have completed enrollment and are pending FDA panel review, more than tripling the data set available for review of the information. This data volume will allow for a more appropriate scientific review.

2) The current use of the "T" codes is designed to  collect data and allow appropriate analysis of the current clinical use of lumbar disk arthroplasty. This has only been ongoing for 10 months. Therefore Dr. Deyo's request again seems premature.

3) Dr. Deyo's use of the "lumping" term of disk arthroplasty will result in imprecise review and later confusion on a national scale. This could then be misapplied to cervical disks. Here the first two FDA  IDE studies should present to panel in the next 12-18 months. This would be akin to making coverage decisions for total joint arthroplasty looking only at data for total knees and applying it to total hips.

4) At most, an extremely small minority of patients indicated for total disk arthroplasty fall within the CMS purview. It is probably not appropriate at this time for CMS to set national policy on this topic if it does not apply to the CMS covered population.

5) Finally Dr. Deyo is asking for a level of evidence supporting a new technology, that has never previously been applied. In fact, the device met the FDA specified criteria at the initiation of the protocol and has been determined through class 1 evidence to be safe and efficacious. This has been appropriately reviewed through the rigorous FDA IDE process. His request for longer term follow-up as a precondition for a coverage decision is without precedent. Two year data has been the standard for orthopaedic devices for at least several decades. Subsequent 5 year surveillance of the IDE has been established by the FDA as a condition for their approval for the Charite. Asking for longer term data is like asking for longer term reliability data on new automobiles. This is great information, but to have5 year data on cars would mean that in 2005 we would only have access to the technology available in the manufacturing of cars in 2000. A similar analogy for computers would suggest that perhaps Dr. Deyo is still advocating for use of computers with 486 chips because they were more reliable.

Thank you for the opportunity to provide additional input on this topic. If the Coverage and Analysis Group has any further questions on this topic, I would be glad to provide additional input.

Dr.Deyo has made a case for not providing
reimbursement for the implantation of an
artificial disc in "elderly Medicare patients."
He bases this on his observation of studies
having been limited to patients under 60 years of
age. The FDA approved the Depuy device based on
these data. It does not follow that
reimbursement for all Medicare patients should be
disallowed. The logical conclusion to Dr. Deyo's
argument is to restrict reimbursement to
individuals who are less than 60. It should also
be pointed out to Dr. Deyo that the word "data"
is a plural expression and should have been
followed by "are" instead of "is" in the second
paragraph of his letter.
It appears to me that there is a subset of
patients who benefit from this technology. In my
own experience, all the patients in whom I have
implanted the Depuy disc are please with the
outcome.

I am a Board Certified Orthopaedic Spine Surgeon
and Director of The Emory Spine Center. Although
Disc Replacement technology is exciting and has
reasonable short term results, it is true that we
do not know the long term success (>10 years)
compared to fusions nor the long term
complications.

It is valid to be concerned about patients with
osteoporosis and those over age 60 and whether
they are appropriate candidates for motion
preservation. As Dr. Polly states, more data are
being collected every day as part of the FDA
trials.

Perhaps a reasonable interim solution until more
data are available would be to not issue a
national coverage policy at this time or to limit
coverage based on age and/or the presence of
osteoporosis rather than a blanket non-coverage
decisions.

I have reviewed a recent letter sent to CMS by Dr Deyo requesting an NCD on the Charite lumbar disc replacement. Although I support the role that CMS plays in the health care of Medicare beneficiaries, I do not feel that there is sufficient data available to properly determine a role if any for this device in this particular patient population. In fact the studies to date (IDE Clinical Trials) have not included this patient population. Furthermore, this age group is not the target population for vertebral disc replacement. A negative decision could prove harmful in the acceptance of this technology for coverage from private payors in the non-medicare population. There may indeed be a few patients over 60 - 65 age group that could benefit from this device or similar ones under development. Therefore a win-win situation could be that of requiring a coverage-with-evidence development (CDE), the establishment of registry, or requiring Medicare beneficiaries to enroll in a CMS - sponsored clinical trail to gather additional evidence.

A blanket denial at this time by CMS I am afraid as mentioned could cause private payors to reassess their current coverage as well as other such devices currently in clinical trials, therefore possibly shutting down this technology evolution which we and others feel under the right circumstances is indeed beneficial to our patients.

David S. Bradford, Professor Orthopedic Surgery., UCSF School of Medicine.

I am a board certified neurosurgeron who does a large number of spine procedures, including medicare patients. Artificial disc replacement is a great concept in (previously) active people who want to remain active. To deny this procedure to the appropriate medicare population (simply because of age) is an injustice. For someone to decide to exclude patients simply by age makes no sense. Patients should be offered medical and surgical options depending on their individual situation.

Abbott appreciates the opportunity to submit comments on the request for a national coverage decision on lumbar artificial disc replacement. Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products. Abbott Spine, a division of the company, is engaged in the development of future next generation cervical and lumbar disc replacement technologies. Abbott Spine is concurrently developing other novel products, such as those intended to provide spinal stabilization without fusion and others to replace the degenerated nucleus pulposus.

Abbott urges CMS to limit the focus of this coverage analysis and decision to lumbar artificial disc replacement technologies that currently are FDA approved, are under active FDA review for marketing approval or are subject to an IDE. We urge the agency not to expand the scope of the decision in a way that would exclude coverage for future next generation technologies. Next generation lumbar artificial disc replacement technologies differ significantly from CHARITE and other similar first generation systems, which are all reliant on articulating bearing surfaces. Abbott Spine is striving to provide surgeons and patients with arthroplasty solutions which are less invasive, are more physiological and do not involve such radical removal of the disc, are not susceptible to articulating wear and can be more safely revised. Abbott Spine is confident that these differentiating features will ultimately improve patient outcomes beyond current arthroplasty or fusion options.

In addition, such next generation technologies are unlikely to receive FDA approval for at least another 5 years and major U.S. clinical trials have yet to begin. At this time there is no clinical data available for use in assessing therapy outcomes. CMS will be unable to effectively assess these early stage technologies because there is insufficient evidence to form an opinion one way or the other. We do not believe it would be appropriate for CMS to make a coverage decision for these technologies, either positive or negative, based on an absence of data.

Given the absence of clinical evidence to assess outcomes and the likelihood that future next generation technologies could differ significantly from the currently available technologies, we believe it premature to include such technologies in a national coverage decision at this time. We are concerned that a national non-coverage or limited coverage decision would stifle the flow of funding for research and development in this important area of unmet clinical need for Medicare beneficiaries. We believe that future products will significantly improve patient outcomes by being less invasive and safer.

At this time, it may be more appropriate for CMS to leave Medicare coverage policy on future next generation lumbar artificial disc replacement technologies to local contractor determinations. CMS may want to consider examining next generation technologies in the context of agency horizon scanning activities, once clinical evidence becomes available.

Abbott also urges CMS to specify in the coverage decision that Category B IDE clinical trials can be covered at local contractor discretion. While current IDE trials for lumbar artificial disc replacement are designated as Category A, it is possible that future IDE trials could be designated as Category B. Coverage of future Category B IDE trials will greatly facilitate continued research and access to care for Medicare beneficiaries. We note that in a number of recent national coverage decisions, CMS has specified that Category B IDE clinical trials could be covered at local contractor discretion.

We look forward to working constructively with CMS on this coverage decision and other coverage issues related to spine technologies and treatments.

Thank you very much for your consideration.

Sincerely, Barbara J. Calvert Director, Medical Products Reimbursement

I read with great interest Dr. Deyo's comments and recommendations to CMS concerning TDA. It should be noted that Dr. Deyo has neither spinal nor surgical background. Dr. Deyo is an internist who does not treat or care for patients with spinal disorders. His knowledge of the technology and its applications are limited and therefore his comments and recommendations are beyond the scope of his expertise.

The results of total disc arthroplasty in a prospective randomized double-blind study to date have shown equivalent results to spinal fusion in some areas, and superiority in most other categories. As a member of the IDE group that investigated the Charite, I am comfortable that when indicated appropriately for use in the lumbar spine, the patient outcomes will far exceed those of spinal fusion and already have in the short term in the USA. Long term results in Europe have already documented the benefits of arthroplasty, and I believe that Dr. Deyo's recommendation should be vacated in light of the fact that long term clinical analysis is not yet available in the United States.

I would concur with Dr.Deyo that this technology may not be appropriate for elderly or osteoporotic patients; but that in and of itself is not a reason for CMS to fail to evaluate the technology appropriately over a satisfactory time period. Based on the European experience, we predict that in the hands of well-trained dedicated spinal surgeons, this technology can be extended to use throughout the lumbar spine with favorable results.

As physician scientists, it is incumbent upon us to continue to diligently search for new innovative technologies which can help to ease the pain and suffering of our patients with chronic back disease not amenable to conservative management. Our decision-making process should not be influenced by the pecuniary interests of the insurance industry, or medical device manufacturers. Ultimately, only long term outcome analysis will determine the benefit of this and other technologies, and I believe that CMS should await the retrieval of this appropriate data. Anecdotal comments and personal opinions from practioners such as Dr. Deyo and Dr. Leone, with no experience with this procedure are dangerous to progress in the care and treatment of spinal injured patients, as well as to health care in general.

I would whole-heartedly urge CMS to evaluate this technology through appropriate analysis based purely on the science and merits of this technology, and avoid a final decision until all such data are available.

Andrew Cappuccino, MD

Disc arthroplasty surgery is a relatively new option for patients with degenerative disc problems. The major advantage of arthroplasty is motion preservation. While disc arthroplasty is not an option for all patients, it is important to be able to offer this procedure to those patients for whom it is indicated. I support the use of this product in the medicare/disability population.