National Coverage Analysis (NCA) View Public Comments

Lumbar Artificial Disc Replacement

Public Comments

Commenter Comment Information
Sukovich, William Title: Director
Organization: Spinal Surgery Associates, PLC
Date: 03/17/2006
Comment:

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particularly interested in public comments that include evidence that CMS did not review, they are quick to dismiss any unpublished evidence as well as results of

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Carlson, Greg Title: Orthopaedic Spine Surgeon
Organization: Orthopaedic Specialty Institute
Date: 03/17/2006
Comment:

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

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Schwaegler, MD, Paul Title: MD (orthopedic spine surgeon)
Organization: Orthopedics International
Date: 03/17/2006
Comment:

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

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Lasen, John Title: Ortho Surgeon
Organization: Downey Orthopedic Medical Group
Date: 03/17/2006
Comment:

I have used this technology a number of times for my patients and have had favorable results. 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.

Hogan, Janice Title: Partner
Organization: Hogan & Hartson L.L.P.
Date: 03/17/2006
Comment:

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®

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Krzeminski M.D., Joseph Title: Neurosurgeon
Organization: York Neurosurgical Asso.
Date: 03/17/2006
Comment:

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

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Wang, Michael Title: Spine Director
Organization: University of Southern California
Date: 03/17/2006
Comment:

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

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TRIANTAFYLLOU M.D., STEVEN Title: ORTHOPEDIC SPINE SURGEON
Organization: ORTHOPEADIC & SPINE SPECIALISTS
Date: 03/17/2006
Comment:

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

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Press, Joel Title: President
Organization: North American Spine Society
Date: 03/17/2006
Comment:

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

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Strenger, MD, Scott Title: MMM, FACS, CPE; President
Organization: Coastal Neurosciences, d/b/a Coastal Physicians & Surgeons, PC
Date: 03/17/2006
Comment:

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

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Heary, Robert Title: Chairman
Organization: AANS/CNS Section on Spine and Peripheral Nerves
Date: 03/17/2006
Comment:

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

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Ellenbogen, Richard Title: President
Organization: Congress of Neurological Surgeons
Date: 03/17/2006
Comment:

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

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Wirth, Fremont Title: President
Organization: American Association of Neurological Surgeons
Date: 03/17/2006
Comment:

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

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Adams, Nathan Title: Executive Director
Organization: Citizens Health Care Association
Date: 03/17/2006
Comment:

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

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Mutterer, Daniel Date: 03/17/2006
Comment:

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

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Lynch, Ann-Marie Title: Executive Vice President
Organization: Advanced Medical Technology Association (AdvaMed)
Date: 03/17/2006
Comment:

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

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McCormack, Michael Title: Senior Manager, Reimbursement Planning
Organization: Medtronic Sofamor Danek
Date: 03/17/2006
Comment:

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

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Toselli, Richard Title: Worldwide Vice President, Research & Development
Organization: DePuy Spine
Date: 03/17/2006
Comment:
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Wong, Douglas Title: Chief of Orthpedic Spinal Trauma St, Anthony Cen.
Organization: Panorama Orthopedics & Spine Center
Date: 03/17/2006
Comment:

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

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Geisler, MD, PhD, Fred H. Title: CHARITÉ™ FDA IDE Surgeon
Organization: Illinois Neuro-Spine Center at Rush-Copley Medical Center
Date: 03/17/2006
Comment:

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

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Gonzalez, Marc Title: Corporal
Organization: USMC
Date: 03/17/2006
Comment:

I can see no reason why you have stopped the coverage for artificial disk replacement, for qualified patients. This leaves plenty of people with unnecessary, and defintely unwanted, pain. I strongly urge you to reconsider.

Simpson, M.D., Nathan Title: Orthopedic Surgeon
Organization: Powder River Orthopedics and Spine
Date: 03/16/2006
Comment:

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

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Tusing, Jacob Date: 03/16/2006
Comment:

please allow the artificial disc replacement for qualified patients

Sies, Esq., Amy Date: 03/16/2006
Comment:

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

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Gooch, Hubert Title: Surgeon
Organization: Piedmont Spine Associates
Date: 03/16/2006
Comment:

CMS should consider

§ This is a technology designed to preserve motion and is an alternative to lumbar fusion
§ In order to prove the value of this technology, we must have continued access to patients – a coverage with evidence decision would be appropriate.
§ Indications for Use and qualifying criteria that address contraindications will limit utilization in the elderly Medicare population.
§ Ongoing efforts to secure

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Gardner, Paul Title: Neurological Surgeon
Organization: Utah Neurological Clinic
Date: 03/16/2006
Comment:

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

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Vaccaro, Alexander Organization: Rothman Institute, Thomas Jefferson University
Date: 03/16/2006
Comment:

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

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Abdou, Samy Date: 03/16/2006
Comment:

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

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Park, Andrew Title: Director, Baylor Spine Center
Organization: Baylor University Medical Center, Dallas
Date: 03/15/2006
Comment:

It is my opinion that there is enough clinical evidence to support the use of lumbar artificial disc replacement in select patients with lumbar disc degenerative disease. The disc replacement may offer some significant advantages to fusion in the near and long term for patients.

Harbach, Todd Title: Orthopaedic/Spine surgeon
Organization: St Johns Clinic
Date: 03/15/2006
Comment:

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

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Kalamchi, MD, Ali Title: Doctor of Spine Surgery
Organization: Dr. Ali Kalamchi MD, P.A.
Date: 03/15/2006
Comment:

The Total Disc replacement when used for the correct indications will maintain painless mobility and function of an intervetebral disc level. This in turn will decrease the likelihood that adjacent levels will have progressive deterioration, thus giving physiologic benifit to the patient and financial benifit to the healthcare system by decreasing subsequent surgeries.

Bellotte, Jonathan Title: Neurosurgeon, Director of Neurotrauma
Organization: Allegheny General Hospital Neurosurgery
Date: 03/15/2006
Comment:

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

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RALEY, THOMAS Title: orthopaedic spine surgeon
Organization: hanover orthopaedic associates
Date: 03/15/2006
Comment:

total disc arthroplasty- when done on the appropriate patient this procedrue has excellant results. This procedure not only gets people back to their ADLs faster but also saves money in the long run. I believe that this procedure has definite indications in the 30-65 yoa population and denying this to the medicare population would definitely affect some people on medicare and unfortunately other private insurances would follow suite and then it would be denied for everyone.

Dzioba, M.D., Robert Title: Associate Professor of Clinical Orthopaedic Surger
Organization: The University of Arizona Health Sciences Center
Date: 03/15/2006
Comment:

Motion preservation of the lumbar spine is highly desirable as an option in preventing significant additional degenerative disease even in successful spinal fusions. The positive effect of total hip/knee arthroplasty on the quality of life of Americans over the last 40 years speaks volumes on behalf of motion preservation for major joints.

McConnell, MD, Jeffrey R. Organization: Orthopaedic Associates of Allentown
Date: 03/15/2006
Comment:

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

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Anderson MD, Paul Title: Associate Professor
Organization: University of Wisconsin
Date: 03/14/2006
Comment:

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

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Deukmedjian, Ara Title: MD
Date: 03/14/2006
Comment:

This is a necessary technology that should be approved by CMS for patients that qualify surgically.

Wolf M.D., Steven Title: Orthopedic Spine Surgeon
Organization: Orthopedic Institute of Pennsylvania
Date: 03/14/2006
Comment:

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

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Burkus, John Title: M.D., Spine Surgeon
Organization: The Hughston Clinic, P.C.
Date: 03/14/2006
Comment:

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

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Majd, Mohammad Title: MD
Organization: Spine Surgery
Date: 03/14/2006
Comment:

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

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Houle, Paul Date: 03/14/2006
Comment:

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

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Dinh, Dzung Date: 03/13/2006
Comment:

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

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Mudiyam M.D., Ram Title: Ram Mudiyam M.D.,MBA
Date: 03/13/2006
Comment:

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

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James, Stephen Title: Orthopaedic Spine Surgeon
Organization: Resurgens Orthopaedics
Date: 03/13/2006
Comment:

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

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deshmukh, vinay Title: Attending Physician
Date: 03/13/2006
Comment:

To whom it may concern,

I feel the CMS should strongly reconsider its negative judgement on disc arthroplasty. The future of spinal surgery lies in arthroplasty and joint preservation and I feel, as a fellowship trained spinal surgeon, that this decision by CMS will have a chilling effect on the development of treatment for back and neck pain.

Thank you,

Vinay Deshmukh, M.D.

Johnson, J. Patrick Title: Director
Organization: Institute for Spinal Disorders Cedars Sinai Medical Center
Date: 03/13/2006
Comment:

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

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Tromanhauser, Scott Title: Orthopaedic Spine Surgeon
Organization: Boston Spine Group
Date: 03/13/2006
Comment:

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

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MALCOLM, JAMES Title: MD
Date: 03/12/2006
Comment:

LUMBAR ARTIFICAL DISC REPLACEMENT IS EMERGINGTECHNOLOGY THAT SHOULD NOT BE PUSHED ASIDE. WEMAY ALL WANT THIS OPTION IN THE FUTURE, SO ITSHOULD BE SUPPORTED & ALLOWED TO DEVELOP FURTHER,NOT CRUSHED BY CMS.

Yue, James Title: Chief Spine Surgery
Organization: Yale University
Date: 03/12/2006
Comment:

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

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Moldawer MD, Todd Title: Partner
Organization: Southern CA. Orthopedic Institute
Date: 03/11/2006
Comment:

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

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Thompson, Jason Title: Orthopedic Spine Surgeon
Organization: Valley Orthopedic Associates, Division of Proliance Surgeons
Date: 03/11/2006
Comment:

Lumbar artificial disc replacement seems to be a good treatment option for a small segment of the population with select criteria. I would hope that the CMS would allow properly qualified physicians to make that determination and provide this treatment option to their patients. I also believe that surgeons should be subject to an audit by a panel of their peers/contemporaries to review the indications for this procedure.

Cappuccino, Andrew Title: Director
Organization: Buffalo Spine Surgery
Date: 03/11/2006
Comment:

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

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Mummaneni, Praveen Title: M.D.
Organization: Emory University Spine Center
Date: 03/11/2006
Comment:

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

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Moore, Tim Title: Attending Orthopaedic Spine Surgeon
Date: 03/11/2006
Comment:

I commend the people who have come to this difficult decision. I am truly frustrated with spine professionals not acting in the best interest of their patients. Most of the literature about the TDA comes from investigators who have a financial interest in the companies. I refuse to follow a "standard of care" that is determined by spine surgeons who are in the pockets of big business.

Wiles, David Title: Neurosurgeon
Organization: East Tennessee Brain & Spine Center
Date: 03/11/2006
Comment:

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

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Coric, Domagoj Title: President-elect
Organization: North Carolina Spine Society
Date: 03/11/2006
Comment:

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

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Salib, Richard Date: 03/10/2006
Comment:

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

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Harrop, james Title: Assistant Professor Dept of Neurosurgery
Organization: Jefferson Med College
Date: 03/10/2006
Comment:

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

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hacker, robert Date: 03/10/2006
Comment:

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

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Berliner, Kenneth Title: President
Organization: Lone Star Orthopedics
Date: 03/10/2006
Comment:

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

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Zunkeler, Bernhard Date: 03/10/2006
Comment:

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

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Babat, Brett Title: Spine Surgeon
Organization: Premier Orthopaedics
Date: 03/10/2006
Comment:

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

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Holt, Richard Title: Spine surgeon
Organization: Spine Surgery PSC
Date: 03/10/2006
Comment:

The artificial disc technology is here to stay. A randomized study with two year follow-up has demonstrated superiority to fusion surgery. Multiple less rigorous published papers have documented anecdotal success. In our practice which participated in the IDE study the outcomes have consistently compared favorably to fusion patients. I urge CMS to reconsider the noncoverage decision.

Kager, Christopher Title: MD
Organization: Lancaster NeuroScience and Spine Associates
Date: 03/10/2006
Comment:

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

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Nunley, Pierce Title: Director
Organization: Spine Institute of Louisiana
Date: 03/10/2006
Comment:

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

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Wolgin, Mark Title: Orthopedic Surgeon
Organization: Girard Orthopedic Surgeons
Date: 03/10/2006
Comment:

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

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mark, weston Date: 03/10/2006
Comment:

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

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Williams, Jay Date: 03/10/2006
Comment:

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

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Grewe, MD, Kent Title: neurosurgeon
Organization: Northwestern Neurological Associates, PC
Date: 03/10/2006
Comment:

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

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Shuster MD, john Title: MD ortho spine
Organization: northwest orthopedic specialist
Date: 03/10/2006
Comment:

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

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Woods, Michael Date: 03/10/2006
Comment:

It's my understanding that CMS is going to disallow payment for Charite discs. This is wrong and should be readdressed. Many patients will benefit from this new technology and should be allowed to return to functioning members of society.

Hobert, Michael Title: Sales Education Manager
Organization: DePuy Spine, Inc.
Date: 03/09/2006
Comment:

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

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Zakeri, Ahmad Title: Neurosurgeon
Organization: Toledo Clinic
Date: 03/09/2006
Comment:

I strongly disagree with the noncoverage decision. There is clearly a patient population that has pure discogenic pain and if properly selected would benefit from TDA. I believe TDA in the long run would help diminish adjacent level degeneration that we see after spinal fusion and would also preserve more motion, hence more function. Ahmad Zakeri, MD. Neurosurgeon, Toledo, OH.

Bassewitz, M.D., Hugh Title: Attending Spine Surgeon, Desert Orthopaedic Center
Organization: Chief of Surgery, Desert Springs Hospital
Date: 03/09/2006
Comment:

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

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Dietze, Donald Title: Medical Doctor
Organization: The NORTH Institute
Date: 03/08/2006
Comment:

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,

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Shapiro, MD, Michael Date: 03/08/2006
Comment:

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

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Reiter, Mitchell Title: Assistant Professor of Orthopaedic Surgery
Organization: The New Jersey Meidcal School
Date: 03/07/2006
Comment:

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

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Oakley, John Title: Medical Director
Organization: Northern Rockies Regional Pain Center
Date: 03/07/2006
Comment:

I have implanted two Medicare recipients with the Charite' proathesis. One is on medicare disability and under age 65, the other is 67 but with isolated disease at a single level and an otherwise rather young appearing spine. Both have had an excellent outcome with follow-up of 11 months and 3 months respectively.I believe each case should be taken on its individual merits. Age alone is not a contraindication to the implant and in fact de-facto restricts access to care.

Roady, Mark Date: 03/07/2006
Comment:

This technology has the power to change lives. I have seen patients with the devices that can LIVE again and they are so grateful for a second chance to feel outstanding again.

Banco, Robert Title: Chief, Spine Section
Organization: New England Baptist Hospital
Date: 03/06/2006
Comment:

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

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Anson, Philip Date: 03/05/2006
Comment:

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

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Krengel MD, Wally Title: Physician
Organization: Proliance Surgeons
Date: 03/05/2006
Comment:

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

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Copeland, Michael Title: President
Organization: Northern Rockies Neurosurgeons
Date: 03/05/2006
Comment:

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

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Wimberley, David Title: MD
Organization: Fondren Orthopedic Group
Date: 03/05/2006
Comment:

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

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Yeh, Peter Date: 03/04/2006
Comment:

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

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Watters MD, William Date: 03/04/2006
Comment:

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

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Moore, Jeffrey Title: Orthopedic Spine Surgeon
Organization: Tidewater Physicians Multispecialty Group
Date: 03/03/2006
Comment:

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

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Blumenthal, Scott Date: 03/01/2006
Comment:

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

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Gill, Kevin Title: Professor-Orthopaedic Surgery
Organization: UT Southwestern-Dallas
Date: 02/28/2006
Comment:

I have personally performed this procedure on a number of patients with excellent results; often better than fusion results. I find if you pick the correct patient that prefers to receive the latest technology delivered in a technically excellent manner that the results are better than fusion with less co-morbidity. I would request re-review of the noncoverage status on this exceptional technological advance for the spine patient.

Shiau, John Title: Neurosurgeon
Organization: Healthcare Associates
Date: 02/26/2006
Comment:

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

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Marcovici, Alvin Title: MD
Date: 02/25/2006
Comment:

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

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Martin, Steven Title: Sr. Medical Policy Research Scientist
Organization: BlueCross BlueShield of Tennessee
Date: 02/24/2006
Comment:

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

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Sartre, Lana Date: 02/24/2006
Comment:

How can you not cover such an advancement in spine surgery. This would be life changing surgery for those individuals that would qualify for this surgery. I am truley disapointed and ashamed. This is the United States of America. Americans should have the best Technology that is available to them.

Taffel, Bruce Organization: BlueCross BlueShield of Tennessee
Date: 02/20/2006
Comment:

I endorse the noncoverage position as this technology does not demonstrate a long term safety and efficacy profile.

McAfee, Paul Title: Chief of Spine Surgery
Organization: St Josephs Hospital Baltimore
Date: 02/19/2006
Comment:

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

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McDowell, Dr. Gregory S. Title: MD
Organization: OSSM
Date: 02/18/2006
Comment:

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

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Burger, Evalina Title: MD
Date: 02/17/2006
Comment:

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 generatio

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mummaneni, praveen Date: 02/17/2006
Comment:

Artificial discs will offer mobility instead of fusion to potentially thousands of patients. In the long term, this may avoid further fusion surgery.I strongly urge coverage of these implants which have proven themselves in FDA approved trials.

vessa, paul Title: Spinal surgeon
Organization: Somerset Orthopaedic Associates
Date: 02/17/2006
Comment:

indications for tdr parallel those present indications for lumbar fusion except in the case of lumbar instability; most published series of lumbar fusions breakout their indications and by a significant majority painful lumbar degenerative disc disease is the most common indication. the approach is a standard for spinal surgeons accustomed to treating patients with lumbar painful degenerative disc disease

Radden, Louis Title: spine surgeon
Organization: Michigan Spine Institute
Date: 02/17/2006
Comment:

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

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Fogel, Guy Title: MD
Organization: South Texas Orthopedics and Spinal Surgery Associates
Date: 02/17/2006
Comment:

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

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Jaff, Jennifer Title: Executive Director
Organization: Advocacy for Patients with Chronic Illness, Inc.
Date: 02/16/2006
Comment:

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

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