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Old 09-22-2005, 09:38 PM
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Harrison Harrison is offline
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(My thanks to Amy for creating this thread; Crystal and Paulette for editing it for repost)

THANKS TO ALL OF YOU WHO POSTED YOUR STORIES AND COMMENTS WITH CMS.GOV! And thanks to any of you who contacted your surgeon's office to get them involved too! Hopefully our efforts will help convince Medicare to take the lead in supporting ADR technology or at minimum hold off making any more adverse decisions until after more ADR devices are approved by the FDA.

We need those of you who have had successful ADR surgery, those fighting insurance companies, fighting the workers' compensation system, and of course, those receiving Medicare and those filing for disability benefits!

**** also if you've been denied ADR by your insurance...look to see if they referred to CMS's
lack of policy or non support as part of the justification to deny you coverage....if so Please specifically state this information in your comment! They need to know how much their decision affects the coverage decison of our private insurers!

The problem: A very influential gov't organization called CMS (Center for Medicare and Medicaid) is considering a national policy to ban coverage for ADR. There could be a serious backlash on the rest of the ADR community. Private insurers look to CMS to determine their own policy on covering ADR. WE don't need any more obstacles.

A general internist out of the University of Washington, Dr Dayo is spear-heading this
request for a national ban. What can you do?

(1) Post your own public comment at http://www.cms.hhs.gov/coverage/ then click on "submit a comment" and you should be able to find the rest of the way. The CMS website for posting a comment is frequently "down" so please be persistent. There are already a number of surgeons who have posted comments opposing Dr. Dayo's letterbut we need to send a message to CMS with anoverwhelming response against Dr. Dayo! If you continually cannot get though please email Corbin, Niccole L. (CMS/OCSQ) [Niccole.Corbin@cms.hhs.gov] and let her know that you are trying to post but keep getting error messages. Send her your comments as a last resort.

(2) call or email your surgeon's office to make sure they know about this and get involved and
post their own comment.

I learned about this problem with an online article from Healthpoint Capital (pls search their site, as the URL is too long too post)

Which states in part:

"CMS (Medicare) has opened a National Coverage Determination (NCD) request to review coverage of the lumbar artificial intervertebral disc. CMS opened this review because of a request from Richard A. Deyo, MD, MPH, University of Washington, School of Medicine. Dr. Deyo's letter requested CMS not cover total discs due to of alack of data in patients over the age of 60. Whyshould this be a concern for the spinal market? If CMS issues a national non-coverage decision, artificial lumbar discs will not be covered or reimbursed for any Medicare aged patients.

Not only will Medicare aged patients be affected by this NCD, but non-Medicare payers tend to
follow CMS decisions. So, if CMS does issue a non-coverage decision, device companies will have an uphill battle to get all payers to cover and pay or artificial discs. Overturning a national non-coverage decision requires an enormous effort, published data, and years to succeed.

Physicians should be the ones making the final treatment choice for their patients and should be able to use a device if the patient is an appropriate candidate for the treatment. How can the orthopedic and physician community become involved and impact this decision? Medicare is currently accepting public comments to determine if there is adequate evidence for evaluating health outcomes of lumbar artificial intervertebral disc surgery in the Medicare
population. Physicians, professional societies, and industry need to submit comments by September 16, 2005 to CMS with evidence related to this evaluation and request that no national coverage decision be made until further data is collected."

The link for the "letter" by dr. Deyo is here:
here.

I have this information posted under Big Bucket too because I am trying to get everyone's
attention to this important issue.

This is time sensitive...deadline 9/16/05

[ September 16, 2005, 04:23 PM: Message edited by: Amy ]

--------------------
L4-5 & L5-S1
injury 9/01

From: Wisconsin | Registered: Aug 2005 | IP: Logged
Amy
Member
Member # 501 posted 09-08-2005 12:54 PMSeptember 08, 2005 03:54 PM

As of today, here are the public comments posted. If your surgeon is not on this list please contact them. Also please go to the CMS.gov website and post your own comment about a successful ADR that has given your life back, or how you are a Medicare person because of your disability and need ADR, or tell your story of how long and how many non-surgical options you've tried before considering ADR surgery, tell CMS how much research you've done on your own before deciding on ADR over fusion!

Commenter: Araghi D.O., Ali
Date: 08/31/2005
Comment:
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.


Commenter: Armstrong, Larry
Title: Neurosurgeon
Date: 08/30/2005
Comment:
I have great concern regarding a recommendation made to deny all Medicare patients from benefitting from lumbar disc replacement. It seems not only irrational but also impetuous to make a blanket policy concerning so many patientswhen many persons should not be condemned to lumbar fusion and it's potential complications which can be avoided with disk arthroplasty. It is my request that the government further investigate the possible benefits of disk replacement as an alternative to lumbar fusion and it's beneficial outcomes relative to that
procedure.


Commenter: Bauer, R. David
Title: ordinary physician caring for patients
Organization: Garland Spine Center
Date: 08/30/2005
Comment:
The applicability for the Charite in the elderly Medicare population is limited. Dr. Deyo'scomments 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.


Commenter: Brodke, Darrel
Title: Associate Professor
Organization: Department of Orthopaedics, University of Utah
Date: 09/02/2005
Comment:
I have some concerns regarding the NCA and Dr. Deyo's letter delineating his position on Artificial Disc Replacement. While there are significant concerns regarding this technology (as with many technologies that are approved already) in the osteoporotic individual, it is quite clear that not all patients covered under CMS are osteoporotic, or sedentary, or even over the age of 65, for that matter. Our understanding of this new technology (as with all new technologies) is not near what it will be in 10 years. That does not make this experimental or untested. This treatment may in fact be superior to our current treatment options in some patients covered under CMS. As with the many other CMS approved medical devices and treatments, the decision to use or avoid this technology should lie in the hands of the knowledgeable and studied medical professional and the informed patient.


Commenter: Cach, Robert
Title: MD
Organization: Idaho Neurosurgical Center
Date: 08/31/2005
Comment:
I suggest using a stringent list of selection criteria in order to screen patients, particularly the elderly for whom it may be contraindicative. I have implemented this in my practice and it has worked well.


Commenter: Carl, Allen
Title: Professor Ortho Surgery
Organization: Albany Medical College
Date: 08/30/2005
Comment:
I have not used the disc replacement yet but the reported results are generally not different when compared to fusion patients. I am concerned that a physician who is not a spine surgeon is making a statement to deter support of this technology. There has been a concern by this same group about the efficacy of fusion. Since it is not the device alone but the right
patient, right surgery and right surgeon that makes the outcome, denying a technology outright
is unhelpful to the masses.


Commenter: Coric, Domagoj
Title: Neurosurgeon
Organization: Carolina Neurosurgery & Spine Associates
Date: 09/05/2005
Comment:
Dear Ms. Corbin,
I am writing in response to Dr. Richard Deyo's request for a NCD on the CHARITE lumbar artificial disc. I am a practicing neurosurgeon, specializing in spine surgery, at Carolina Neurosurgery & Spine Associates, a fifteen surgeon group in Charlotte, NC. I was not involved in the FDA IDE study for the CHARITE disc. I do have personal experience with total
disc replacement (TDR). I have placed 14 CHARITE artificial discs in patients with mechanical low back pain with lumbar spondylosis/degenerative disc disease. I also have experience with the Kineflex lumbar artificial disc system (Spinal Motion) as a principal investigator in that FDA IDE study which utilizes the CHARITE disc as its control. I am also a principal investigator in both the FDA IDE studies for the cervical Bryan Artificial Disc (Medtronic Sofamor Danek)which is currently closed and in follow-up as well as the ongoing Kineflex cervical artificial disc system (Spinal Motion).

I would like to begin by addressing the applicability of the CHARITE disc to the Medicare beneficiary population. Certainly, osteoporosis is a concern in this patient population. Osteoporosis is a relative contraindication for artificial disc placement, as it is for spinal fusion procedures. Equally as self-evident is the fact that not every person over 65 years of age has osteoporosis. It is unconscionable to discriminate against healthy, active elderly patients without osteoporosis by denying coverage to this entire patient population. As an active spine surgeon who routinely operates on patients aged 65-90 years, I am mystified by the criticism that patients over 60 years old were not included in the CHARITE IDE study. When controlled for osteoporosis, which can be easily and accurately diagnosed, there is no scientific reason that the CHARITE IDE data shouldn't be directly applicable to the elderly population. In fact, the vast majority of pharmaceutical and spinal implant studies are conducted on younger patients and subsequently extrapolated to the elderly population.

Artificial disc replacement, like spinal fusion, is a major surgical procedure with significant risks including potentially life-threatening complications. Most of these risks are related to the surgical exposure, not the device itself, and are shared with spinal fusion procedures. Therefore, artificial disc replacement, like spinal fusions, should be reserved for when a patient's symptoms have become intolerable. At that juncture, Medicare beneficiaries, like all patients, should be allowed access to state-of-the-art FDA approved procedures/implants.

The CHARITE FDA approval came largely on the strength of a prospective, randomized study initiated in 1999. The scientific community regularly bemoans the paucity of prospective, randomized Class I evidence available in the spine literature. The CHARITE IDE study represents this most credible form of scientific data. Inexplicably, after appropriately criticizing the scientific validity of the European case series data supporting the CHARITE disc, Dr. Deyo cites the Van Ooij et al. European case series (Class III evidence) as evidence of the CHARITE's faults. Dr. Deyo goes on to cite the popular press and undocumented heresy from "some surgeons" concerning the durability and effectiveness of the CHARITE prosthesis. Conversely, several recent peer-reviewed, scientific journals (SPINE, Journal of Neurosurgery-Spine)have reported on the safety and efficacy of total disc replacement.

In closing, as a novel and innovative technology, artificial disc replacement deserves scientific scrutiny. The ultimate efficacy of the CHARITE prosthesis will not be be fully known until long-term follow-up is achieved. But, based on current, objective medical evidence, total disc replacement deserves to play an increasingly prominent role in the treatment paradigm of symptomatic spondylosis and degenerative disc disease. The Medicare population should not be denied access to this medical advance by a national non-coverage decision. The applicability of this technology to the Medicare population should be determined by individual spine surgeons in consultation with each unique patient.

Thank you for your consideration. Please contact me if I can provide any further information.

Sincerely,
Dom Coric, M.D.


Commenter: Gill, Kevin
Title: Professor, Department of Orthopaedic Surgery
Organization: UT Southwestern Medical Center-Dallas, TX
Date: 08/29/2005
Comment:
I am concerned about the decision CMS has made to possibly undertake a National Coverage Analysis of the Charite. As an investigator of Synthes ProDisc Artificial Disc and a physician who has treated DDD for several years, I am concerned that enough data does not exist to make this decision. All the work in the world does not include patients age 65+ and those with Osteoporosis. The fact the CMS would not approve an add-on payment for Charite states the obvious. The studies to date do not include an over 60 population. My thanks for your consideration of this important topic where a NCA is not warranted in my opinion. Kevin Gill, MD


Commenter: Gross, Elliot
Date: 08/31/2005
Comment:
I believe that the artificial disc replacement should be approved by Medicare. Patients who need relief from lower back pain will have a much faster recovery from the artificial disc than with traditional fusion methods. Most of the elderly with still require fusion since they have arthritic facet joints. However, those patients who have worn out disc and good facets joints would benefit. Thank you
Elliot Gross MD


Commenter: jaikumar, sivakumar
Date: 08/30/2005
Comment:
I am concerned about the decision CMS has made to possibly undertake a National Coverage
Analysis of the Charite. As a spine surgeon a who treats DDD, I am concerned that enough data does not exist to make this decision. The artificial disc is not used in patients over 65+ or people who have osteopenia for reasons of subsidence of graft. The studies to date do not include an over 60 population.


Commenter: Lehman, Richard
Title: Prof of Surgery,Div. of Neurosurgery
Organization: Robert Wood Johnson Med. School
Date: 08/30/2005
Comment:
There are patients on Medicare Disability for non-spinal reasons that maay require an
artificial disc.


Commenter: Leone, Anthony
Title: MD
Date: 09/07/2005
Comment:
The lumbar artificial disc replacement is already being heinously misused in the Buffalo area. There is a surgeon here putting implants in at levels NOT approved by the FDA and placing implants at multiple levels (also not approved by the FDA). By deviating from the FDA recommendations, it is more than likely we are not going to see good outcomes for this
procedure. As such, physicians and patients alike are unlikely to consider this option in the future. THANK YOU


Commenter: Lockstadt, Harry
Title: Private citizen, M.D.
Date: 08/30/2005
Comment:
The procedure should be available to patients to find in medically necessary. Denial for use of
this medical device on the basis that it may be misused is discriminatory. This scrutiny, has not been used to deny treatment for other medical devices.

The device should be available for people who medically need it and have the appropriate
indicators for it.

Denial should be based on appropriate medical indicators, as I am having pain, and have the
appropriate indicators for its use, and the device will allow me to regain my improvement in pain and function, I would expect to have coverage for the device.

Quality-control, FDA studies, indeed have demonstrated that this is the case, and therefore
should be covered.

Thank you


Commenter: Martin, George
Title: Neurological Surgeon
Date: 08/30/2005
Comment:
I have been performing fusion surgery on my patients for the last six years and, at last an
option exists to preserve motion. If Dr. Dayo's methodology was used to approve every new instrumentation or drug then I would be prescribing alot of aspirin. Most ethicists look down on trials with placebo surgeries. Granted this device has not been thoroughly investigated in patients with osteoporosis neither has many of our current instrumentation systems. To categorically deny coverage would discriminate against the non-elderly Medicare population and prevent any further trials in the above 60 age group.


Commenter: McDonnell, Mark
Title: Spine Surgeon
Date: 08/30/2005
Comment:
Medicare does not need to repeat the excellent job done by the FDA last year in approving
lumbar disc replacement. Any objection to the approval for Medicare patients because of a
contraindication of osteoporosis is absurd. This is a poorly concealed effort by the health insurance industry to avoid payment for the device and for the procedure


Commenter: Pashman, Robert
Title: Director of Scoliosis
Organization: Cedars Sinai Institute for Spinal Disorders
Date: 08/30/2005
Comment:


Artificial disc replacement in its current form (Charite) will never be applicable
to the over 65 year old Medicare population. This demographic was not included in the
clinical trial because of bone density issues and multilevel pathology indicating that its manufacturer was skeptical about its indication for this population.
Moreover, the European data has been at most equivacal for efficacy and safety based on longterm followup. Even Artifical Disc Replacement advocates are worried about its longterm success.My opinion is that Medicare coverage for Artificial Disc Replacement in its current form
would be an ill advised diversion of precious taxpayer resourses for an unproven, and potentially unsafe medical procedure.

Robert S Pashman, MD
Director of Scoliosis and Spinal DeformityCedars Sinai Institute for Spinal Disorders
310 423 9983


Commenter: Pledger, Stephen
Title: Orthopedic Spine Surgeon
Organization: Pledger Orthopedic & Spine Center
Date: 08/30/2005
Comment:
I am of the belief that alternatives to spine care are a good thing. Motion preservation surgery is the next wave of the future of spine surgery. Is the 1st generation of Total Disk Replacements(Charite') the right TDR? Probably not. I don't think that preventing this technology from occuring, is not the right answer either. If noncoverage of this technology occurs, I am afraid that the advancements in TDR surgery will be hampered. The initial study of the Charite' for the FDA, did not show great results. It did help 60% of the people. Unfortunately medicine is not an exact science. I would like the coverage for Total Disk Replacements occur.


Commenter: Polly, David
Title: Professor and Chief of Spine Surgery
Organization: University of Minnesota
Date: 09/06/2005
Comment:
To: Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd (Mailstop C1-09-06)
Baltimore, MD 21244

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 have 5 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.

David W. Polly, Jr.,MD
Professor and Chief of Spine Surgery
Department of Orthopaedic Surgery
University of Minnesota
2450 Riverside Ave S R200
Minneapolis, MN 55454
612 273-7951 fax: 612-273-7959


Commenter: Ryken, MD, Timothy
Title: Associate Professor
Organization: University of Iowa
Date: 08/30/2005
Comment:
Re: Witholding Medicare Coverage of Lumbar Artificial Disc Replacement

I am surprised that consideration is even being given to witholding the possibility of lumbar arthroplasty from the Medicare population. All of the effort expended by the FDA in reviewing and rendering opinions on instrumentation and procedures would seem to be disregarded by such an action. Certainly consideration needs to be given to appropriate patient selection but there would seem to be much more appropriate means of monitoring useage than simply prohibiting the entire procedure from a large and important segment of the United States population.
T Ryken, MD
Neurosurgery
University of Iowa


Commenter: seybold, eric
Date: 08/30/2005
Comment:
As a spine surgeon I have implanted more than 30 TDR since December. I perform many anterior fusions as well and the results are significantly better with the TDR. Removing the TDR reimbursement would be a huge error and set a very poor precedent to the other insurers. Be progressive, not regressive. Remember the issues with the pedicle screws years ago ? Now pedicle screws are probably the most powerful tool we have for spine stabilization.Medicare has a code for BMP(bone morphogenetic protein), why not for the TDR. The TDR is cheaper than an anterior fusion ! Please reconsider.
Thank you Eric
Seybold, M.D.


Commenter: Shiau, John
Title: Neurosurgeon
Organization: Healthcare Associates
Date: 08/30/2005
Comment:
I appreciate Dr. Richard Deyo's concern regarding the misuse of the Charite disc. However, as a
neurosurgeon who performs the operation, I am also concerned that the issuance of a NCD would severely limit the patients who would benefit from the arthroplasty.

The treatment options that are available to a patient should not be legislated. Instead, like all treatments, clear indications and patient selection should be left to the doctor and patient. Osteoporotic patients and patients with severely degenerated facets are not candidates for the surgery and should not be offered to those patients. This does not need to be legislated.

I had a young patient who was on medicare who did well with the Charite. Should she be denied arthroplasty because the government assumes that surgeons will not be judicial and prudent on their own?

It is time that surgeons accept responsibility and the government stop trying to be big brother
all the time.


Commenter: Amy
Date: 09/07/2005
Comment:
I am a 36 year old 2-level ADR candidate who is fighting hard for insurance coverage while also applying for disability benefits. ADR, aka TDR, should not be a treatment limited to the independently wealthy who can pay out-of-pocket. My career and life has been devastated by a trauma-induced back injury. I've paid a lot of money each month to keep my insurance under Federal and State COBRA laws, only tobe denied a medically necessary surgery. My insurer cites to the lack of support and policy by CMS to justify not covering my surgery! If CMS encourage ADR coverage, CMS may be able to prevent me and other "young" people from going on long-term disability!

There are many of us "young" people with back/lumber disc problems demandingADR because we KNOW fusion will absolutely cause immediate range of motion problems and necessarily long-term problems on adjacent vertebrae levels.

We know this because we do our research and get first, second, and maybe more opinions with
orthopedic and/or neuro-surgeons, but only after exhausting lesser invasive treatments from pain management physicians, physical the

Commenter: Singer, M.D., Phillip
Organization: Western Kentucky Orthopedics
Date: 08/31/2005
Comment:
In regards to the artificial disc replacement surgery, I too am concernedabout its uses in the general population. I have only limited experience with this device in private practice (3 patients) but I have extensive experience in performing lumbar fusions. I believew that in the right patient who meets the strict criteria for candidacy for this procedure,it can be a true blessing. Compared to the alternative of fusion surgery, the artificial disc implantation surgery is better tolerated and relatively simpler to perform. The hospital stay is less, and recovery time short. In my area (Kentucky) were the majority of patients are smokers and subsequently the failure of fusion is high, the advantage of arthroplasty with its non-dependence on bone healing is a great advance for my patients. Its use in the medicare population will be limited but there are a few circumstances in which it may be warranted. I currently am seeing a 48 yr old female with Medicare and Medicaid who has been symptomatic now for 7 years with an isolated degenerated lumbar disc. She meets all the necessary criteria for the procedure and she is a heavy smoker. She has already failed to heal a cervical fusion. Obviously I am reluctant to offer a lumbar fusion for this patient, but a disc replacement may help her greatly. Also one should note that the report by Oiij referred to in the letter my Dr. Deyo included complications from quite early in the disc replacemet era. These complications led to many changes in this procedure which will have (as demonstrated with the experience of the IDE) significant impact on the complication rate. The majority of those complications were obatained with a more crude set of instruments with which to perform the surgery as well as a
less refined set of indications and appropriate patient profiles.Caution is warrented with this procedure but I do believe it is a great advance in the treatment of some patients with highly symptomatic disc disease who would otherwise be facing a fusion which is a road from which there is no return.


Commenter: Smith, Michael
Title: Admin Assistant
Organization: Private Practice Physical Therapy
Date: 08/23/2005
Comment:
I myself was included in the FDA Trial for the CHARITE Disc Replacement on April 20, 2001 that took place in Texas. I was 38 when I had this procedure done and I currently work in Physical Therapy. I have seen great strides made in this field over the last 11 years that have concerned me.

I won't begin to pretend I know all the ins and outs of what is at stake here, tho I know it is of concern for many people. I read Allison Widmanns letter and I see what she says has truthful, heartfelt concern.

I too see many elderly patients that come to our clinic daily. I see their pain because I have shared that type of pain for many years of my life. I also read with great interest the letter from Dr. Richard A. Deyo MD, MPH. I am sure the points he raises are of great concern to him that may of may not be valid points. Again, I cannot speak of what I do not know.

I can however, take exception to excluding a sect or certain population of people that may benefit greatly from this area of the medical profession. Having all the problems I had in the past, it still took me almost a year to accept the risk and or unwanted outcomes that this "risky" surgery came with. I did not take it lightly. Having had back surgery 3 times prior to this also came with those same "risks" but I took them then, so I agreed to take them again.

We all know that "ALL" surgery comes with certain risks. Some groups have higher risks than others, some not so many, but the fact is I did it at a time that it was labeled "Trial" and now the FDA is allowing a 3 level trial at this same location where just 3 years ago, they only allowed 1 level. The main difference is that now it is accepted as practice. With the FDA giving their go-ahead, and I know that does not hold a lot of weight for some, but this fact allows the private insurance establishment to "opt" for this, to those that will cover it.

It would truly be a last stop for so many folks that are in their Medicare years now, giving that all applicable guidelines that are set in place have been met.


The fact that CMS has taken this stand and included it says great things for those of us looking over the the elder youth. Having had this done myself, I was glad to have seen these changes come down some months ago when I read it. I now feel concerned enough to reply.

Again, I hold no weight in the Medical Community, but feel that the CHARITE disc replacement should be allowed.

Thank you for this chance,

Michael A. Smith


Commenter: Sullivan,M.D,J.D., Daniel J.
Date: 08/30/2005
Comment:
I am a fellowship-trained spinal surgeon, as well as a member of the Ohio bar. After reviewing the comments of Dr.Deyo, a non-spinal trained ,non-surgeon, I would make the following comments: 1.The device in question is no more likely to pose a 'threat" to elderly Medicare patients than any number of other spinal implants presently approved for use by Medicare. Indeed it is less likely than any number of devices that are presently authorized for use in the surgical treatment of elderly spines, given the fact that use in the setting of osteoporosis is listed as a contra-indication. (in contradisdiction to the present overuse of Medicare approved pedical screw constructs in osteopenic spines!!) 2.If the TDR is not certified by Medicare virtually all third party payers will attempt to use Medicare's position to refuse to authorize payment for the device.This will be done for business, not medical treatment related reasons. 3.Not all Medicare patients are elderly. Patients who qualify for Medicare due to disability(e.g. SSI) are often not elderly, and have spines like others in their age cohort. These people would be denied treatment allowed for, and paid by other ins. carriers, for the same spinal conditions,only because of the Medicare noncert.
4. The concern expressed for the problems of revision of TDR are overblown in Dr. Deyo's letter. In all cases short of anterior migration of the TDR, revision is done thru a posterior appraoch by way of a posterior fusion with pedical screw fixation, not by the anterior route. As for the rare case of migration anteriorly, this should be handled in the same manner as anterior migration of any one of the several interbody devices presently approved for use in the Medicare population. Anterior revision is equally problematic in both settings. In my view, total disc replacement is
a potentially useful addition to the surgical treatment of intractable pain, refractory to non-operative treatment,in a patient who is not osteopenic, who has a single level of pain-generating pathology in the lumbar spine. It should only be implanted by a specialist of adequate training(not a one day session in a calf lab)who is prepared to address not only routine insertion, but also the potential complications attendant in major spinal surgery. By the way, I do not believe the hype in the WSJ, or elsewhere, re the impact of the TDR.The "big money" will turn out to be wishful thinking on the part of the manufacturer, and shareholders The indications for this implant are appropriately narrow on the present FDA release,and the device is challenging to implant even for those of us who can do it correctly. The "market"for this device is small. Especially so in the Medicare group, for the reasons noted
above. It is disconcerting ,however, as a surgeon ,to once again have to justify the use of a devise to a medical provider who is by experience and training not qualified to have his opinion taken seriously. DJS MD,JD


Commenter: Taddonio MD, Rodolph F
Title: Professor of Orthopaedics & Neuresurgery
Organization: New York Medical College, Valhalla, NY
Date: 09/02/2005
Comment:
Although Dr. Deyo's comments have theoretical merit, they are from a physician with no surgical experiernce in caring for spine surgery patients. To remove artificial disc replacement from the approved proceedures for Medicare benificiaries, would limit care options for many patients who would qualify under the reccommended strict indication guidlines. This would have a trickle down effect from private insurers, whose prime motivation is monetary. Certain patients would seek care out of the country leaving their post operative management as well as their complications to USA doctors. This is not the way medical care should be administrated and provided in the country.. His request should be denied.


Commenter: Tromanhauser, MD, MBA, Scott G
Title: Assistant Clinical Professor Orthopaedic Surgery
Organization: Tufts University School of Medicine
Date: 09/06/2005
Comment:
I am a Board-Certified Orthopaedic Surgeon with a practice limited to surgery of the adult degenerative spine. I am also one of the investigators involved with the original FDA IDE trial of the Charite device. In addition I am an instructor for Depuy Spine, teaching the technique of disc replacement to surgeons from across the country. I and my colleagues have now done approx. 60 cases of disc replacement and have had generally outstanding results compared to spinal fusion. We have had very few complications.

In general disc replacement surgery will not apply to Medicare patients unless they are younger disabled patients covered through social security disabilty insurance.

I must urge this panel to keep in mind that Dr. Richard Deyo, although well meaning, has had a clearly stated public agenda against most forms of spinal surgery. Furthermore he has no direct experience with selecting, operating upon or follwing up patients who have had disc replacement. His opinion is one of an "outsider"
without the appropriate experience to comment.
For the same reasons, most of us don't make
comments about treatments we don't have direct
experience with.

There is extensive experience in Europe with disc replacement, with over 15 years follow-up in some patients. There have not been any catastrophic failures that are known (in all likelihood they would be known at this point)

Depuy Spine has put together an impressive educational program to teach orthopaedic and neurosurgical spine surgeons how and to whom this technology should be applied. I am proud to be associated with the program and believe that they have created the "gold standard" for companies involved in safely introducing new technology to the market place.

I think this disc replacement technology is an important addition to our treatment choices for this devastating problem of chronic, disabling, painful degenerative disc disease.


Commenter: van Dam, Bruce
Title: M.D., Clinical Associate Prof. of Ortho., UCSD
Organization: Spondylos Medical Group, Inc.
Date: 08/31/2005
Comment:
1. Dr. Deyo is well known nemesis of spinal surgery. Therefore, his remarks should be received in that light. It's a good thing someone like him didn't prevail in the late 1960's and early 1970's. Otherwise there might not have been progress in the field of total hip replacement. And how many thousands of individuals have benefited from that procedure over time?
2. Osteoporosis presents challenges in the care of many orthopaedic conditions. Will CMMS now deny coverage for the internal fixation of hip fractures in persons older than 60 years because it can be associated with complications? I trust not.
3.It's very simple. If a person is osteoporotic an artificial disk replacement is not an option, at least with present technology. If he is not osteoporotic, despite his chronologic age, he is potentially a candidate. Why deny this treatment option to a person just because of his age? That is what Medicare will do if a non-coverage
decision is made.


Commenter: varnavas, GUS
Date: 08/30/2005
Comment:
I am troubled by the consideration for NCA status for the Charite lumbar disc. This is an ill advised, mis-informed and premature consideration. I have treated patients with a variety of spinal pathology both surgical and non-surgical. Lumbar arthroplasty has had in my experience excellent results-you can talk to as many of my patients as you wish. We must bear in mind that arthroplasty is a very specific surgical therapeutic option for a very narrow clinical situation. It is not for every one and in no way should be viewed as a " new substitute" for arthrodesis. It is a further option for a small subset of patients who must meet strict criteria. Please do not throw the baby out with the bath water. There are going to be certain patients who happen to be on medicare who will and should have this option available to them. please do not close the door.
Thank you


Commenter: Widmann, Allison
Title: Social Worker
Date: 08/19/2005
Comment:
As a social worker who works with patients prone to bone/spine disorders (End Stage Renal Disease patients whose lack of kidney function brings about calcium/phosphorous imbalances leading to the possibility of extensive bone disease including spine disease), I sincerely hope CMS will base its coverage decision on timely, up-to-date research and not on a letter crafted by a physician whose university receives extensive funding from spinal product manufacturers who incidentally are not affiliated with the CHARITE. The CHARITE is FDA approved, it is tested with 10-year follow up studies, it has proven to enhance patient outcome greatly, and is probably the last hope for my patients with chronic back problems. I was sufficiently upset by Dr. Deyo's letter that I drafted a response letter which will be sent to the email as indicated at the bottom of this page. Maybe Medicare's population is primarily elderly, but my Medicare patients are very definitely following the issue of Medicare coverage of the CHARITE and we were all stunned that the NCD that was opened was for no-coverage, Take my word for it, there are ESRD (and I'm sure disabled, too) patients who know exactly what is at stake and are counting on CMS to take care of their non-dialysis health care needs in the same way that CMS takes care of their dialysis needs so reliably.

Thank you, on behalf of the ESRD population who want back pain relief like everyone else.

Allison Widmann, LCSW-C, LICSW


Commenter: Williams, Brian
Date: 09/01/2005
Comment:
We have had very succesful results with our patient's. Patient selection is very important. This is a technology and treatment option that should be allowed for use by Medicare recipients.


Commenter: Williams, M.D., Keith
Title: Spine Fellowship Director
Organization: University of Tennessee Campbell Foundation
Date: 09/08/2005
Comment:
To: Coverage Analysis Group
Center for Medicare & Medicaid Services
7500 Security Blvd (Mailstop C1-09-06)
Baltimore MD 21244

I am writing this to ask CMS to give a positive coverage decision to lumbar artificial disc replacement. This procedure has been evaluated by prospective randomized trials with stringent data collection for the FDA IDE trial. The two year results were found to be essentially equivalent to fusion in a select group of patients with regard to safety and efficacy.

This procedure is indicated for treatment of single level degenerative disc disease at the L4 or L5 disc level in patients with normal facet anatomy.Many Medicare beneficiaries will not meet these criteria. However there certainly are many younger patients with debilitating back pain who do meet these requirements and are Medicare beneficiaries.

To suggest that this procedure should be categorically denied to these patients is unacceptably biased and prejudicial, not to mention not supported by scientific evidence. To be certain additional data is needed, and will be collected as the "T" code for this procedure will facilitate patient tracking and data base construction. Also the idea that a procedure should not be allowed if there is a "risk" of misuse or abuse is an impossible standard since this possibility exists for each and every CPT code currently available.

I appreciate this opportunity for comment, if I can provide any additional information please contact me.


Commenter: Yalamanchili, Kennedy
Date: 08/30/2005
Comment:
Approval for arthroplasty is essential for themedicare/medicaid population. THis portion of thepopulation should not be restricted access tomedical care available to other insurers who havealready approved this technologic advance orpatients in EUrope and other countries who havebeen undergoing treatment with this technology forfifteen+ years. Judicious implementation of thistechnology will be key in outcomes, however, the recertainly is a subset of patients in the medicare/medicaid population who need this form of
treatment.


Commenter: Young, Robin
Title: President
Organization: Robin Young Consulting
Date: 09/05/2005
Comment:
I am writing in opposition to Dr. Deyo's letter and to encourage CMS to approve as soon as possible reimbursement for non-fusion, implant devices like the Charite. Agreeing with Dr. Deyo's assertions and denying reimbursement for such non-fusion, implant devices like Charite would unfairly hurt a very large number of Medicare patients.

Spinal fusion is a final resort treatment. Non-fusion implants, of which Charite was the first to be approved by the FDA and which cost about the same as fusion, demonstrated superiority over fusion in a prospective, radomized clinical trial for certain, non-osteoporotic patients with severe DDD.

While Medicare patients have higher rates of osteoporosis than the general population, the number afflicted is still in the minority. Approximately 15% of Medicare's beneficiaries are under 65 years and of those who are over 65, nearly 29 million do not have osteoporosis if the standard incidence rates ((NHANES III Phases 1 and 2: Prevalence estimates of osteopenia and osteoporosis for men and women, the National Health Survey and studies at the National Osteoporosis Foundation) are to be believed.

But the greater issue is, frankly, the need to expand the continuum of care for patients with severe DDD. Presently, the therapeutic transition from non-fusion non-implant (discectomy, facetectomy) to fusion is much too short. Medicare patients require more therapeutic choices than simple non fusion(non-implant) or Fusion to treat severe DDD.

The trend to more therapeutic choices but without an appreciable increase over other implant costs (i.e. Fusion) should be supported by CMS if for no other reason than to better serve the approximately 35 million non osteoporotic Medicare beneficiaries.

I have over 27 years of experience in the medical technology arena and I have seen a wide range of new medical technologies come to market. The controversies surrounding Charite are not any more excessive than other technologies and, frankly, has been healthy for all concerned. But Dr. Deyo's focus on the debate obscures the larger issue of improved choice for both patient and surgeon.

Thank you,
Robin R. Young

--------------------
L4-5 & L5-S1
injury 9/01

From: Wisconsin | Registered: Aug 2005 | IP: Logged
Amy
Member
Member # 501 posted 09-08-2005 12:56 PMSeptember 08, 2005 03:56 PM

FYI..I spoke to someone in "reimbursement" at Depuy (Charite) and she informed me that yes they are doing what they can to inform CMS and their trained surgeons about this situation.

Just because Charite may have contacted your Charite surgeon...please follow up. They might be too busy to see one email or notice one call but if you follow up too...maybe they will take action and get involved!

--------------------
L4-5 & L5-S1
injury 9/01

From: Wisconsin | Registered: Aug 2005 | IP: Logged
Amy
Member
Member # 501 posted 09-08-2005 01:26 PMSeptember 08, 2005 04:26 PM

just got another call back from depuy...they agree that it is very important for us as well as surgeons to post public comments with CMS.

It is particularly important for us to spell out to CMS how influential CMS policy can be with private insurers deciding whether to cover adr or not. If you've been denied coverage and are appealing this decision...request from your insurer everything they've used to justify their decision... in my denial info ...my insurer cited CMS as not yet covering ADR!


It is also particularly important to spell out whether or not you are part of the disability population of Medicare beneficiaries...remind them that not all Medicare recipients are over 60! Or whether you will fil
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Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
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  #2  
Old 09-26-2005, 05:42 PM
Kim Kim is offline
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Join Date: Apr 2005
Posts: 267
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Awww Geez Amy give it a break would ya???? This is too silly and most of us are in so much pain as I am that we dont have time for this type of stuff.
Bickering and petty arguments do nothing but tear down what this board was intended to do for all of us be a SUPPORT PLACE that we could come to in times of need.
Maybe its time to take 3 deep breaths and think before we type????
__________________
Kim
Herniated disc L5/S1 2000 Discectomy 10/2003 Rhizotomy 8/2004 and 3/2005Discogram 11/04 grade 7 tear L5/S1
L4/L5 Grade 5 tear with herniation and stenosis
Evaluated by Dr Blumenthal at TBI
2/2005 ADR 2 level recommended
2 level lumbar fusion
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  #3  
Old 09-26-2005, 08:46 PM
luvmysibe luvmysibe is offline
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Join Date: May 2005
Posts: 556
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As a forum member who volunteered to assist with writing, editing, reading, or whatever else needed to be done for the betterment of the site; it was never my intent to take control of someone else's thread. The sole purpose of editing was to streamline the format into a more user friendly manner. None of the statements, names, references, etc. were altered. My reasons for assisting were and are only to serve those who use this forum. Rather than accusing other members, let's redirect that energy to helping those in need.

Graciously,
__________________
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L5/SI Charite
7/18/05 Dr. Howard
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  #4  
Old 09-28-2005, 09:17 PM
jf110 jf110 is offline
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Join Date: Mar 2005
Posts: 93
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Kim, Im with you on this one!. Just read what Kim wrote, Its about helping each other as much as possible. Thx, JF110
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