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  #1  
Old 01-14-2005, 06:33 PM
cervie queen cervie  queen is offline
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At Dr. Regans talk last Sunday many of the ADR patients talked about their insurance paying for the surgery. All that I was aware of were PPO or HMO. Several had problems with their insurance, and are still in the process. I did not hear of even one Medicare patient. Dr. Regan said that there was a new code effective this month, so that maybe Medicare would pay. Some of us are on disability, ie: medicare, and is anyone aware of an ADR patient either accomplished or in the pipeline for Medicare as the first payer?
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Old 01-14-2005, 06:39 PM
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Harrison Harrison is offline
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Cervie, in all seriousness, I think you know more about this than anyone here (sorry). There were a few responses to the earlier thread, but you already know that. Any new members out there have more light to shed on crappy medicare coverage?!

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Old 01-14-2005, 07:14 PM
Mariaa Mariaa is offline
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Hilary,
I heard the same thing you did which was that Medicare was going to start approving this surgery. At least this is what I thought I heard!
My insurance is WC so even tho I have Medicare it doesn't matter as it won't cover the lumbar area that is a WC injury. However, it will cover the cervical area so I'm hoping that Medicare is soon going to start picking up the bill for both lumbar and cervical disc replacement..
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Old 01-14-2005, 11:30 PM
Justin Justin is offline
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This does not pertain directly to Medicare, but I thought it was worthy to post.

Aetna ADR Policy (10/12/04)

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Clinical Policy Bulletins

Number: 0591
Subject: Intervertebral Disc Prostheses


Important Note

This Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Aetna) for a particular member. The member's benefit plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Issues Manual can be found on the following website: http://cms.hhs.gov/manuals/pub06pdf/pub06pdf.asp.


Policy


Aetna considers implantation of artificial prosthetic intervertebral discs experimental and investigational for degenerative disc disease or post-laminectomy syndrome.


Note: Examples of prosthetic intervertebral discs are the Bryan cervical disc prosthesis the Maverick artificial disc prosthesis, the ProDisc, and the Charite artificial disc.


See also CPB 016 - Back Pain - Invasive Procedures.


Background


Since the 1970s, investigators have been working on developing an artificial prosthetic intervertebral disc (IVD) that can be used to replace degenerated intervertebral discs (Diwan, 3t al., 1997). Most of the published clinical evidence for artificial prosthetic intervertebral discs has been of those that replace the entire disc.


The major potential advantage of a prosthetic intervertebral disc over current therapies for degenerated disks (such as spinal fusion or diskectomy) is that the prosthetic intervertebral disk is intended to restore or preserve the natural biomechanics of the intervertebral segment and to reduce further degeneration of adjacent levels. Investigators have found, however, that creation of an intervertebral disc prosthesis poses significant challenges with respect to prosthetic design and materials:


The biomechanics of the intervertebral segment are difficult to replicate
It is a challenge to find materials that are both biocompatible and effective
The prosthetic disc should achieve long-term mechanical fixation.


A number of different intervertebral disc prostheses have been developed. The most widely studied intervertebral disc prosthesis is the Charite prosthesis (Waldemar Link GmbH & Co, Hamburg, Germany). This prosthesis was initially developed in 1984 but has undergone several design modifications. The latest modification, the SB Charite III, has been implanted in the largest series of patients with IVD replacement to date. Lemaire, et al. (2000) reviewed a series of 105 patients who all had SB Charite III prostheses implanted in the lumbar spine. Good results in terms of improvement in back or leg pain, return to work, and complication rates were described. Several other reviews also reported fair-to-good results. Published studies of prosthetic intervertebral discs, however, have been limited to retrospective case series and small, short-term uncontrolled prospective studies. These studies have focused on establishing the technical feasibility and safety of the prosthetic intervertebral disc.


Diwan, et al. (1997) concluded that intervertebral disc prostheses are �in their infancy.� Carefully controlled prospective studies are needed to establish the effectiveness of the prosthetic intervertebral disc and compare the safety and effectiveness of disc replacement with spinal fusion. Therefore, intervertebral disc prostheses are considered experimental and investigational.


In a review of the literature on total disc replacement for chronic low back pain, de Kleuveret al (2003) stated that there are currently insufficient data to evaluate the performance of total disc replacement adequately. There is no evidence that disc replacement reliably, reproducibly, and over longer periods of time fulfills the three primary objectives of clinical efficacy, continued motion, and few adjacent segment degenerative problems. Total disc replacement appears to be associated with a high rate of re-operations, and the potential problems that may occur with longer follow-up have not been addressed. Thus, total disc replacements should be considered experimental procedures and should only be used in strict clinical trials.


van Ooij et al (2003) stated that disc prosthesis surgery is rapidly becoming an option in treating patients with symptomatic degenerative disc disease. Only short-term and mid-term results are described in the literature. Most operated patients belong to the age group of 30 to 50 years. In these active patients, complications can be expected to increase with longer follow-up, similar to total joint replacements in the extremities. The authors reported a series of 27 patients who presented with unsatisfactory results or complications after Charite disc replacement. Most patients were operated on at the L4 - L5 and/or the L5 - S1 vertebral levels. The patients were evaluated with plain radiography, some with flexion-extension x-rays, and most of them with computed tomography scans. The group consisted of 15 women and 12 men. Their mean age was 40 years (range, 30 - 67 years) at the time of operation. The patients presented to the investigators a mean of 53 months (range 11 - 127 months) following disc replacement surgery. In two patients, an early removal of a prosthesis was required and in two patients a late removal. In 11 patients, a second spinal reconstructive salvage procedure was performed. Mean follow-up for 26 patients with mid- and long-term evaluation was 91 months (range 15 - 157 months). Early complications were the following: In one patient, an anterior luxation of the prosthesis after 1 week necessitated removal and cage insertion, which failed to unite. In another patient with prostheses at L4 - L5 and L5 - S1, the prosthesis at L5 - S1 dislocated anteriorly after 3 months and was removed after 12 months. Abdominal wall hematoma occurred in four cases. Retrograde ejaculation with loss of libido was seen in one case and erection weakness in another case. A temporary benefit was experienced by 12 patients, while 14 patients reported no benefit at all. Main causes of persistent complaints were degeneration at another level in 14, subsidence of the prosthesis in 16, and facet joint arthrosis in 11. A combination of pathologies was often present. Slow anterior migration was present in two cases, with compression on the iliac vessels in one case. Polyethylene wear was obvious in one patient 12 years after operation. In eight cases, posterior fusion with pedicle screws was required. In two cases, the prosthesis was removed and the segment was circumferentially fused. These procedures resulted in suboptimal long-term results. In this relatively small group of patients operated on with a Charite disc prosthesis, most problems arose from degeneration of other lumbar discs, facet joint arthrosis at the same or other levels, and subsidence of the prosthesis. It is to be expected that many more patients will be seen with late problems some years after this operation as the survivorship will decrease with time.


On the other hand, Caspi et al (2003) reported results of lumbar disk prosthesis (Charite) after a follow-up period of 48 months. These investigators found that 80 % of patients reported satisfactory to very good results. Poor results were reported by four patients, one of whom underwent postero-lateral fusion and another is waiting for the same operation. There were two dislocations of the prosthesis followed by immediate revision surgery. The authors concluded that contraindications for surgery appear to be the principal cause of failure rather than the prosthesis itself.


In a multicenter, prospective, randomized investigational device exemption study of the Charite intervertebral disc, Geisler et al (2004) compared the Charite artificial disc with lumbar fusion using the BAK cages in patients with lumbar degenerative disc disease (n = 304). The authors found that the neurological status was equivalent between the two groups at 6, 12, and 24 months, post-operatively. They concluded that the Charite intervertebral disc is safe and effective for the treatment of single-level degenerative disc disease, resulting in no higher incidence of neurological complications compared with BAK-assisted fusion, and leading to equivalent or better outcomes (as indicated by visual analog scale and Oswestry Disability Index scores) compared with fusion with those obtained in the control group and those reported in the lumbar fusion literature. The finding of this study is promising. However, longer follow-up is needed to determine the durability of the Charite artificial disc and its long-term safety and effectiveness.


Furthermore, Huang and Sandhu (2004) stated that total disc replacement is an exciting technology that may one day replace fusion as the gold standard treatment for degenerative disc diseases, but it is currently an experimental procedure in the United States. Promising short- and mid-term results have been reported for total disc replacement, but longer follow-up and randomized trials comparing total disc replacement to fusion and non-surgical treatment are needed to fully define the role of total disc replacement in the spine surgeon's armamentarium. This is in agreement with the observation of Guyer and Ohnmeiss (2003) who concluded that although still in the early phases of development, functional disc replacement will become a part of the spine surgeon's armamentarium for the treatment of patients with disc-related pain unresponsive to non-operative care. However, as with any new technology, there must be careful consideration of the safety of the devices, and their effectiveness will only be determined in long-term follow-up studies.


A consultation document prepared for the National Institute for Clinical Excellence (NICE, 2003) concluded that �[c]urrent evidence on the safety and efficacy of prosthetic intervertebral disc replacement does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research.� The report states that, in reaching this conclusion, the specialist advisors expressed concern about the lack of good quality long-term evidence. Although this procedure has potential advantages over alternative treatments, it also has the potential for serious complications.


Based on an assessment of the evidence, the Ontario Health Technology Advisory Committee (OHTAC) concluded that �evidence of improved outcomes of artificial discs � in spinal surgery for [degenerative disc disease] is insufficient at present to warrant widespread adoption of these technologies� (Ontario Ministry of Health and Long-Term Care, 2004; OHTAC, 2004).


The above policy is based on the following references:


Diwan AD, Parvataneni HK, Khan SN, et al. Current concepts in intervertebral disc restoration. Orthop Clin North Am. 2000;31(3):453-464.
Buttner-Janz K, Schellnack K, Zippel H. An alternative treatment strategy for lumbar disc damage using the SB Charite Modular Disc Prosthesis. Z Orthop. 1987;125:1-6.
Benini A. Indications for single-segment intervertebral prosthesis implantation. Revista Di Neuroradiologia. 1999;12(Suppl):171-173.
Buttner-Janz K, Schellnack K, Zippel H. Biomechanics of SB Charite intervertebral disc endoprosthesis. Int Orthop. 1989;13(3):173-176.
Kostuik JP. Intervertebral disc replacement. Experimental study. Clin Orthop Relat Res. 1991;337:256-260.
Lemaire JP, Skalli W, Lavaste F, et al. Intervertebral disc prosthesis. Results and prospects for the year 2000. Clin Orthop. 1997;337:64-76.
Cinotti G, David T, Postachini F. Results of disc prosthesis after a minimum follow-up period of 2 years. Spine. 1996;21:995-1000.
Griffith SL, Shelokov AP, Buttner-Janz K, et al. A multicenter retrospective study of the clinical results of the LINK SB Charite intervertebral prosthesis: The initial European experience. Spine. 1994;19(16):1842-1849.
David T. Lumbar disc prosthesis: Surgical technique, indications and clinical results in 22 patients with a minimum of 12 months follow up. Eur Spine J. 1993;1:254-259.
Buttner-Janz K, Schellnack K. Principle and initial results with the Charite Modular type SB cartilage disk endoprosthesis. Magy Traumatol Orthop Helyreallito Seb. 1988;31(2):136-140.
Sott AH, Harrison DJ. Increasing age does not affect good outcome after lumbar disc replacement. Int Orthop. 2000;24(1):50-53.
Zeegers WS, Bohnen LM, Laaper M, et al. Artificial disc replacement with the modular type SB Charite III: 2-year results in 50 prospectively studied patients. Eur Spine J. 1999;8(3):210-217.
Kostuik JP. Intervertebral disc replacement. Experimental study. Clin Orthop. 1997;337:27-41.
Leong JC, Chow SP, Yau AC. Titanium-mesh block replacement of the intervertebral disk. Clin Orthop. 1994;300:52-63.
Enker P, Steffee A, Mcmillin C, et al. Artificial disc replacement. Preliminary report with a 3-year minimum follow-up. Spine. 1993;18(8):1061-1070.
Hou TS, Tu KY, Xu YK, et al. Lumbar intervertebral disc prosthesis. An experimental study. Chin Med J. 1991;104(5):381-386.
Schneider PG, Oyen R. Surgical replacement of the intervertebral disc. First communication: Replacement of lumbar discs with silicon-rubber. Theoretical and experimental investigations. Z Orthop Ihre Grenzgeb. 1974;112(5):1078-1086.
Urbaniak JR, Bright DS, Hopkins JE. Replacement of intervertebral discs in chimpanzees by silicone-dacron implants: A preliminary report. J Biomed Res. 1973;7(3):165-186.
Pointillart V. Cervical disc prosthesis in humans: First failure. Spine. 2001;26(5):E90-E92.
Agence Nationale d'Accre'ditation et d'Evaluation en Sante' (ANAES). Disc prostheses and arthrodesis in degenerative disease of the lumbar spine. Summary. Paris, France; ANAES; May 2000.
Mayer HM, Korge A. Non-fusion technology in degenerative lumbar spinal disorders: Facts, questions, challenges. Eur Spine J. 2002;11 Suppl 2:S85-S91.
de Kleuver M, Oner FC, Jacobs WC. Total disc replacement for chronic low back pain: Background and a systematic review of the literature. Eur Spine J. 2003;12(2):108-116.
National Institute for Clinical Excellence (NICE). Interventional procedures consultation document - prosthetic intervertebral disc replacement. London, UK: NICE; October 2003. Available at: http://www.nice.org.uk/article.asp?a=87530. Accessed October 20, 2003.
Zigler JE, Burd TA, Vialle EN, et al. Lumbar spine arthroplasty: Early results using the ProDisc II: A prospective randomized trial of arthroplasty versus fusion. J Spinal Disord Tech. 2003;16(4):352-361.
Guyer RD, Ohnmeiss DD. Intervertebral disc prostheses. Spine. 2003;28(15 Suppl):S15-S23.
van Ooij A, Oner FC, Verbout AJ. Complications of artificial disc replacement: A report of 27 patients with the SB Charite disc. J Spinal Disord Tech. 2003;16(4):369-383.
Caspi I, Levinkopf M, Nerubay J. Results of lumbar disk prosthesis after a follow-up period of 48 months. Isr Med Assoc J. 2003;5(1):9-11.
Geisler FH, Blumenthal SL, Guyer Rd, et al. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: Results of a multicenter, prospective, randomized investigational device exemption study of Charite intervertebral disc. J Neurosurg (Spine 2). 2004;1:143-154.
Huang RC, Sandhu HS. The current status of lumbar total disc replacement. Orthop Clin North Am. 2004;35(1):33-42.
Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat. Artificial discs: Applications to cervical and lumbar spinal surgery for degenerative disc disease. Health Technology Scientific Literature Review. Toronto, ON: Ontario Ministry of Health and Long-Term Care; March 2004.
Ontario Health Technology Advisory Committee (OHTAC). Bone morphogenetic proteins (BMP) and artificial disc use in spinal surgery for degenerative disc disease (DDD). OHTAC Recommendation. Toronto, ON: Ontario Ministry of Health and Long-Term Care; March 24, 2004.





Property of Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 12, 2004
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  #5  
Old 01-14-2005, 11:41 PM
Justin Justin is offline
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The information below was obtained from the Centers for Medicare & Medicaid Services


Look on Page 4 for ADR Codes

ADR Procedure Codes

Justin
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Old 01-15-2005, 11:26 AM
lisa lisa is offline
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The study coordinater I talked to for the flexicore clinical trials I was looking into said that they had done the operation on Medicare patients so it seems possible.
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Old 03-08-2005, 03:25 PM
ans ans is offline
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My primary insurance Empire Health Choice of NY ok'd a two-level disc replacement; however, there's a small-print caveat in their authorization that they reserve the right not to pay. Confusing yes, and Regan's office asked for money up-front b/c of this.

I'm not clear if Blue Cross pays or not. I read that ADR is considered experimental via a Google search but Regan's office says sometimes they will kick in as a secondary. (Who knows how Uitilization Review thinks?). Delamarter's partner said the Blue Cross w/probably be the last holdout in paying for ADR surgery.

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Severe, extensive DDD, considered inoperable by Dr. Regan, Lauressen, & some guy at UCLA. Severe foraminal stenosis (guess they can't operate!) and some spinal cord compression that Lauryssen would fix if gets outta hand.
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