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Insurance Hell All insurance-related matters are here: Medicare, worker's compensation, appeals, denials, insights, wins, losses. PRICING is here too. Note: This forum has posts from 2006 forward. Older ones are in the Big File.


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  #11  
Old 02-11-2009, 02:53 PM
JasonR JasonR is offline
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Quote:
Originally Posted by Robert G View Post
You state that the denial was based on the assertion that ADR is unproven long term. But how does that assertion relate to the specific provision of the insurance contract (the policy, the document setting forth the benefits terms and exclusions). What I need to know is how the insurance contract somehow allows the insurer to deny coverage because the long term effects of ADRs are unknown.

Does the policy indicate that the lack of long term clincal data renders ADR experimental and/or investigational, and therefore uncovered or excluded?

Does your contract contain a provision that states that even if a service or device is investigational or experimental, it is nevertheless covered if it is deemed medically necessary? If so then you need to make an end run around the experimental/investgational hurdle by demonstrating Medical Necessity as that term is used in the policy.

Look at your policy and post the provisions here.

Regards
Oddly enough that's the exact same argument I just made to my insurance company. That nothing in my statement of benefits limited procedures based on the lack of long term data. FDA approval was specifically mentioned, but the prestige disc is FDA approved. I'm still waiting on a reply. Below is a paste of what I sent my HR department to forward on to my insurance company.

******, it may also be worth asking Allied to clarify the "General
Limitations" listed in our plan, specifically item 25 on page 18.

Item 25 states:
for experimental or investigational services; or, for treatment
not deemed clinically acceptable by (1) the National Institute
of Health; or (2) the FDA; or (3) the Centers for Medicare
and Medicaid Services (CMS); or (4) the AMA; or a similar
national medical organization of the United States;

This item seems to be the focus of the denials to date. The procedure/device is specifically not experimental nor investigational as it has received FDA approval. It has also not been deemed clinically unacceptable by any national medical organization so I'd like them to detail why the procedure would not be covered if nothing in our plan specifically excludes it. I don't see how this item applies to my situation and I did not find any other items under the general limitations which would apply to my case.

Another question I'd like answered is this; Is precertification
necessary if this is done as an outpatient procedure? Barring complications
there will be no overnight stay at a hospital and in fact the stay should
be less than 12 hours. My understanding is that outpatient procedures do not
require a precert. I was informed of this by an Allied employee I
called when trying to get an answer on one of the appeals. However, the
nature of the procedure and the fact that it will be done at a hospital on an
outpatient basis may affect how the procedure is viewed.

Now I do understand that part of the precertification process is to
review medical necessity but the denials have relied almost completely on the
argument that the procedure is experimental and unsafe. Both of those
statements are countered by the FDA's approval. Their claims of
long-term safety as a reason in my opinion are not justified because there is no
clause in our plan that limits benefits based on the lack of long
term data for an FDA approved procedure(which there is long term data
available as the procedure has been performed in Europe for many years) and because
Allied does cover the procedure based on separate phone
conversations that both myself and my Dr's nurse had with Allied prior to submitting the
precertification request.

As far as medical necessity goes the FDA has determined that
artificial disc replacement is as effective as fusion for the treatment of
degerative disc disease. I have neck pain and radiating pain through both
arms. The arm pain has become quite severe lately along with numbness in my
right hand. With these symptoms I would have been considered an ideal
candidate of a clinical study a few years ago so I fit the "profile" for disc
replacement.
__________________
DDD C5/6. Incorrectly diagnosed as tension headaches in September 1997.
Nearly continuous headache since.
Began having pain in wrists in 2000, believed it was onset of carpal tunnel.
In 2005 pain began getting worse.
Diagnosed as DDD in July 2007.
Surgery recommended after 6weeks of PT made the pain worse.
ADR scheduled for Jan 26, 2009. Rescheduled for August 5!
Bryan disc finally FDA approved, and just in time too.
Neck was all jacked up and had to be fused unfortunately.
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  #12  
Old 02-12-2009, 09:36 PM
gclc1457 gclc1457 is offline
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Join Date: Oct 2008
Posts: 7
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Ok, with the help of my human resources dept i was able to obtain a member handbook which shows the glossary of terms in the handbook. The following is uhc definition in my handbook of an experimental,investigational, and unproven service:

Medical,surgical,diagnostic,psychiatric,substance abuse or other healthcare services, technologies, supplies, treatments, procedures, drug therapies or devices that , at the time the company makes a determination regarding coverage in a particular case are dtermined to be:

* not approved by the u.s. Food and drug administration (fda) to be lawfully marketed for the proposed use and not identified in the american hospital formulary service, or the united states pharmacopoeia dispensing information, as appropriate for the use; or

* subject to review and approval by any institutional review board for the proposed use; or

* the subject of an ongoing clinical trial that meets the definition of a phase 1,2 or 3 clinical trial set forth in the fda regulations, regardless of whether the trial is actually subject to fda oversight; or

* not demonstrated through prevailing peer-reviewed medical literature to be safe and effective for treating or diagnosing the condition or illness for which its use is proposed.

As i have mentioned, i have had 2 appeals denied by uhc for adr surgery. They claim the surgery is an unproven service. I could really use some help. Thanks everyone gary
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  #13  
Old 02-13-2009, 02:36 PM
kimmers kimmers is offline
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Join Date: Jan 2008
Posts: 554
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My suggestion is to contact the Insurance Warrior. Harrison has her website on this forum. She gave me some good ideas for the appeal.
I can tell you insurance companies will argue two things at the minimum to state something is "experimental" or "investigational", although it isn't. Medicare in their CMS? report did not approve disc replacement for patients over 60. Now most patients under medicare are 60 or more but not all. So as I understand it if you are insured under medicare and less than 60 they will cover it.

The second thing they argue is that the FDA requested further studies for the lumbar disc ProDisc and therefore they (the insurance co) consider it investigational/experimental. Now I don't remember if that applies to the Prestige disc but they wanted five years after FDA-approval to approve the disc. So going on that assumption, ProDisc will be viable for them in 2011.

You really have to get at them by finding the evidence they have approved the Prestige and pester them to death. Cervical ADR is proving to be very effective with a high percentage of successful surgeries.

Good luck,

Kimmers
__________________
hurt back lifting, herniated disc at L4/L5. DDD
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  #14  
Old 02-15-2009, 10:59 AM
curly4552 curly4552 is offline
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Join Date: Feb 2009
Posts: 8
Default here is Oxfords ADR policy, any suggestions???

Oxford Health Plans > Medical and Administrative Policies > Artificial Disc Replacement for Degenerative Disease

Title of Policy
Artificial Disc Replacement for Degenerative Disease
The services described in Oxford policies are subject to the terms, conditions and limitations of the Member's contract or certificate. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage enrollees. Oxford reserves the right, in its sole discretion, to modify policies as necessary without prior written notice unless otherwise required by Oxford's administrative procedures. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies as well as SecureHorizons and Evercare. Certain policies may not be applicable to Self-Funded Members and certain insured products. Refer to the Member's plan of benefits or Certificate of Coverage to determine whether coverage is provided or if there are any exclusions or benefit limitations applicable to any of these policies. If there is a difference between any policy and the Member’s plan of benefits or Certificate of Coverage, the plan of benefits or Certificate of Coverage will govern.

Policy #: DME 021.9 T3 Non-Coverage Statement:
Policy is applicable to:

Commercial plans AARP MedicareComplete, Evercare Plan DH and SecureHorizons MedicareComplete, including Group Retiree Plans underwritten by Oxford Health Plans (NY/NJ/CT), Inc. (CMS Contract Numbers: H0752, H3107 and H3307)

Policy and Rationale:
Oxford does not reimburse Members or providers for the Charite™ Artificial Disc or ProDisc-L for medical or surgical services related to its implantation. There are no conclusive data from controlled scientific studies showing that, in the short term (less than 24 months), the Charite Artificial Disc or ProDisc-L is superior to the techniques of standard disc surgery and spinal fusion. There is no data from any controlled long term studies demonstrating the efficacy and durability of the Charite artificial disc or ProDisc-L, or proving that it does in fact provide increased spinal mobility and a reduction in degenerative changes of adjacent intervertebral spaces. The Charite artificial disc and ProDisc-L are therefore considered to be not medically necessary for one spinal level (L4-S1). Due to insufficient clinical evidence to support medical efficacy, Artificial Disc Replacement for the treatment of Degenerative Disc Disease with the Charite artificial disc or ProDisc-L will not be reimbursed by Oxford. This service and/or device is not proven to be clinically effective and, therefore, is considered experimental/investigational for more than one spinal level. Oxford does not reimburse Members or providers for the ProDisc-C Total Disc Replacement, or for medical or surgical services related to its implantation. There are no conclusive data from controlled scientific studies showing that, in the short term (less than 24 months), the ProDisc-C Total Disc Replacement is superior to the techniques of standard disc surgery and spinal fusion. There are no data from any controlled long term studies demonstrating the efficacy and durability of the ProDisc-C Total Disc Replacement, or proving that it does in fact provide increased spinal mobility and a reduction in degenerative changes of adjacent intervertebral spaces. The ProDisc-C Total Disc Replacement is therefore considered to be not medically necessary for spinal levels C3-C-7. Due to insufficient clinical evidence to support medical efficacy, Artificial Disc Replacement with the ProDisc-C Total Disc Replacement for the treatment of Degenerative Disc Disease will not be reimbursed by Oxford. This service and/or device is not proven to be clinically effective and, therefore, is considered to be not medically necessary. Please refer to the following policies: Experimental/Investigational Treatment for Commercial Plans and Experimental/Investigational for Medicare . Description of Service/Assessment/Background Information:
Degenerative disc disease (DDD) is a common condition occurring in many Americans; incidence increases with age. It can occur at any level of the spine. The disease process often involves a fissure and herniation of one of the gelatinous discs that separates the vertebrae. In some cases, a protruded disc or herniated disc material compresses a spinal nerve root, causing numbness and pain along the neural pathway. Symptoms of lumbar disc disease can include acute or chronic back pain, referred leg pain, sensory changes, leg weakness, reflex changes, or a combination of these symptoms. The extent of disc disease is determined with diagnostic tools such as plain radiography, myelography, electrodiagnosis, discography, computed tomography (CT) scanning with and without contrast medium, magnetic resonance imaging (MRI) with and without contrast medium, and bone scintigraphy. Standard therapy for disc disease involves a period of conservative treatment, consisting of physical therapy and reduced activity, followed by gradually increasing mobilization and exercise. Surgical treatment is undertaken only for those patients who have not improved with conservative treatment or who have a severe neurological impairment such as cauda equina syndrome. Although minimally invasive procedures such as microdiscectomy and laparoscopic discectomy are available, approximately 200,000 disc excision surgeries are performed in the United States each year and the standard approach has been the open laminectomy with discectomy, in which portions of the vertebra and disc are removed. Patients may also undergo fusion of the vertebrae adjacent to the affected disc using bone grafting. However, problems may arise after spinal fusion including nonunion and loss of spinal curvature and flexibility. A new technique has been developed in which the diseased spinal disc is removed surgically and replaced with an artificial disc. Artificial discs for the cervical and lumbar sections of the spine are available. These devices are composed of two cobalt-chromium endplates that are attached to the vertebrae and a polyethylene disk that is inserted between the metal endplates. The goal of this procedure is to reduce or eliminate back pain while maintaining spinal curvature, flexibility and load bearing. Discs are implanted through an anterior approach and are attached to vertebrae with screws, teeth, ridges, or fins. Several models have a rough or porous coating to encourage bone in growth around the disc. Current models use metal alloys, ultra-high molecular weight polyethylene, and ceramics. As of August 2006, two artificial lumbar discs, the Charite and the ProDisc-L, have received FDA approval. The Prodisc-C Total Disc Replacement has recently received FDA approval for use in cervical levels C3-C-7. Presently, there are no long term controlled studies demonstrating the efficacy, safety, and durability of this product. Therefore, conclusions supporting long term clinical efficacy, continued motion, and adjacent segment degenerative problems cannot be made due to insufficient data. Due to the prevalence of cervical disc disease, and the progressive degenerative nature of spine problems, Oxford has determined that longer follow up, as well as better quality evidence, is needed to determine the durability of the ProDisc-C Total Disc Replacement and its long term safety and efficacy. Please note that this decision means that the all surgical and hospital services for a disc implantation, including the surgeons' fees and the inpatient facility stay, are not covered for a technology that Oxford considers unproven or experimental. Research Evidence:
The largest study selected for detailed review was conducted by Lemaire et al., who implanted 154 SB CharitIII in 105 patients with lumbar disc disease. These patients (mean age, 39 years) had low back and radicular pain that had progressed for a mean of 6 years. After disc replacement, Lemaire et al. calculated the relative gains that these patients made on the Stauffer-Coventry inventory and found that they increased from a mean of 48% at 3 months to 73% at 12 months and 82% at 51 months. Poor results were attributed to osteoporosis, osteoarthritis, thoracolumbar kyphosis, or secondary progression of facet joint syndrome. At the final follow-up, 60% of patients had returned to the same type of work, 27% had changed work, and 13% were unemployed. For the patients who were able to return to work, the mean time to return was 9 months.5 Cinotti et al. reported a retrospective case series of 22 patients with lumbar disc degeneration and 24 patients with failed disc excision surgery who received SB CharitIII. After a mean 3.2-year follow-up, the general clinical improvement was excellent for 24% of patients, good for 39%, fair for 30%, and poor for 7%. As a secondary outcome measure, Cinotti et al. measured vertebral motion for the 50% of patients who underwent disc replacement at L5/S1. In these patients, mean vertebral motion was 9° at L5/S1 and 16° at L4/5. Overall, 19% of the patients required spinal fusion or a second disc replacement surgery due to poor outcomes or migration, dislocation, or failure of the prosthetic disc.4 Two other small, uncontrolled studies evaluated the SB CharitIII. Caspi et al. implanted 23 of these devices in 20 patients6 and Sott and Harrison implanted 15 prostheses in 14 patients.7 The latter study involved somewhat older patients whose ages ranged from 31 to 61 years versus the 24- to 50-year age range in the study by Caspi et al. Caspi et al. included only patients who had low back pain with or without radicular pain for at least 5 years; Sott and Harrison did not report symptom duration. Sott and Harrison used the Stauffer-Coventry inventory and found that outcomes were good for 71% of patients, fair for 14%, and poor for 14%. Caspi et al. relied on the Oswestry Disability questionnaire combined with a visual analog scale for pain and reported that outcomes were excellent for 50% of patients, good for 18%, fair for 14%, and poor for 18%. Despite their somewhat older age, patients in the Sott and Harrison study fared better in returning to work, with 86% of them returning to the same type of occupation in a mean of 5 months and 14% of them being retrained to perform less physically demanding work. In contrast, 5% of patients in the Caspi et al. study resumed physical labor, 75% returned to light or sedentary work, and 20% claimed to be too disabled to work. In 2002, Lemaire reported on 100 patients 10 to 13.4 years after SB CharitIII implantation.17 In this group, 147 discs were implanted at 1 level in 54 cases, at 2 levels in 45 cases, and at 3 levels in 1 case. The clinical results were analyzed using a modified Beaujon score. The results were expressed as relative gain, defined as post-operative score minus pre-operative score divided by maximum score minus pre-operative score. Overall, 90% of the patients had Beaujon scores of excellent or good after more than 10 years. There was no significant difference in results between patients who had been implanted with one or two prostheses. Complications were present in 9% of the patients. They included neurological, vascular, mechanical problems, many of which resolved. At the time of publication, the morbidity of the series was 2%. Complications of the SB CharitIII disc in 27 patients 11 to 127 months after implantation were analyzed by van Ooij et al. They concluded that most problems were related to degeneration of other lumbar discs, facet joint arthrosis at the same or other levels, and subsidence of the prosthesis.16 In 2004, Geisler et al. reported a randomized, controlled study of surgical treatment methods in 304 patients with degenerative disc disease.12 205 patients underwent treatment with the Charite and 99 patients underwent spinal fusion. The two groups had equivalent neurological status postoperatively at 6, 12, and 24 months. The patients who had fusions had a greater incidence of both major and minor complications postoperatively at 0 to 42 days. In the two year followup, treatment was classified as a success for more disc replacement patients than fusion patients. There was also a higher level of satisfaction with treatment in the group that had disc replacement as compared to the group that had fusion. A subset of this group was analyzed by Guyer et al.13 Results of the mean Oswestry Disability Index score for the BAK fusion group was 69.6 +/- 12.8 preoperatively and 27.5+/- 26.4 at 24 month followup. The corresponding mean Oswestry score for the Charite disc patients was 70.9 preoperatively and 30.0 at 24 month follow-up. Blumenthal et al. and McAfee et al. reported new data in 2005 on what appears to be the same group of patients reported on earlier by Geisler et al. In a prospective, multicenter study, 304 patients were randomized 2:1 to treatment with the Charite artificial disc or an instrumented anterior lumbar interbody fusion, with the fusion acting as a control group. Patients were followed for 24 months. Outcomes were measured with the Oswestry Disability Index questionnaire, a Visual Analog Scale, and the SF-36 Health Survey. Both groups improved following surgery, although patients who received the artificial disc recovered more quickly than the control group. Patients in the artificial disc group had lower levels of disability than the control group at every time interval post surgery, had a shorter hospitalization, and had a lower rate of reoperations (5.4% vs. 9.1%).1 At 24 months post surgery, the artificial disc recipients had a satisfaction rate of 73.7% and an increase in employment of 9.1%. The control group had a satisfaction rate of 3.1% and an increase in employment of 7.2%. Flexion/extension range of motion in the artificial disc group increased by 13.6%, but in the control group decreased by 82.5% at 24 months post surgery as compared to the baseline.2 The artificial disc group had better restoration of disc height than the control group and there was less subsidence in the artificial disc group than the control group. In 2005, Lemaire et al. reported additional results on what appears to be the same subset of 100 patients implanted with the Charite prosthesis.3 Fifty-four 1-level, forty-five 2-level, and one 3-level procedures were performed for a total of 147 prosthetic implants in 107 total patients. Seven patients were unavailable for long-term follow-up. Of the 95 patients eligible to return to work, 88 (91.5%) returned to work and 12 of these patients worked in heavy labor and returned to the same job. Mean flexion/extension motion was 10.3 degrees for all levels. Mean lateral motion was 5.4 degrees. Two patients experienced slight subsidence, although they did not require further surgery. No subluxation of the prostheses and no cases of spontaneous arthrodesis were identified. A good or excellent clinical outcome rate of 90% was obtained. As a condition of FDA approval, the manufacturer of Charite must conduct a postapproval study of a maximum of 366 subjects (201 randomized investigational subjects, 67 training investigational subjects, and 98 control subjects) to be evaluated for a total of 5 years post-implantation.9 Zigler reported on results of the ProDisc artificial disc with at least six months follow-up. 55 patients were randomized to receive the ProDisc II implant and 23 patients were randomized for a lumbar spinal fusion.14 The ProDisc II patients had shorter hospital stays, tended to have higher satisfaction rates, experienced more improvement in flexion and lateral bend range of motion, and faster improvement in ambulation and recreational activity than the fusion patients. Both groups had reduced scores in the Oswestry Low Back Pain Disability Questionnaire and the visual analog scale as compared to preoperative values. Delamarter et al. reported on 53 patients with at least six months followup. In this sample, 35 patients received the ProDisc II implant and 18 patients had lumbar spinal fusion.15 Disc replacement patients reported less pain and disability than fusion patients in the early period following surgery, however there was no difference after 6 months. Tropiano et al. reported on 64 patients who had single or multiple-level implantation with a Prodisc total lumbar disc replacement.26 The follow-up period was 7 to 11 years with a mean of 8.7 years. There were significant improvements in back pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Radiographs did not identify loosening, migration, or mechanical failure in any patient. A patient age of less than 45 years and a history of prior lumbar surgery had small but significant negative effects on outcome. Five patients had approach-related complications. The relatively small number of patients and lack of randomization and a control group are weaknesses of this study. In 3 case series (n=22, 25, 104 patients) of ProDisc implants, Bertagnoli reported statistically significant improvements in pain and disability at 2 to 4 year follow-up.23-25 The relatively small number of patients, lack of control groups and short-term follow-up are weaknesses of these studies. The safety and efficacy of the MAVERICK artificial disc will be compared with spinal fusion surgery in patients with degenerative disc disease at one level between L4-S1 (inclusive). In this study, patients will be randomly assigned either an artificial lumbar disc, or spinal fusion surgery. The clinical trial will be used to help support an application to the FDA that could allow the approved future use of the device. Results from studies of artificial lumbar discs are promising. There is not a high incidence of serious complications, patients have slightly shorter recovery times and good percentages of returning to work as compared to fusion surgery. [However at the time of this document, the only large, randomized study supporting the Charite was funded in whole or part by the manufacturer. Although there are a number of studies of the Charite artificial disc, Lemaire (2002) and Lemaire et al. (2005) appear to be derived from the same group of patients and the same group of investigators and Geisler et al. (2004), Guyer et al. (2004), Blumenthal et al. (2005), and McAfee et al. (2005) also appear to be derived from the same group of patients and the same group of investigators.] Furthermore, Putzier et al. reported on 53 patients implanted with the Charite disc at 1 or 2 levels with an average follow-up of 17 years. Segmental fusion or instrumented spondylodesis was required in 23% as a result of pain, implant failure or fracture, or implant subsidence or dislocation. The artificial disc factured in 13% of the patients. Spontaneous ankylosis occurred in 60% of the patients.18 In a prospective randomized multicenter trial, safety and efficacy of the Bryan cervical artificial disc was compared to fusion in 33 patients with single-level DDD. At 24 month follow-up, no device-related complications had occurred and patients with the Bryan disc had clinical outcomes similar to the patients who had undergone spinal fusion.19 An analysis of 10 patients who received the Bryan cervical disc suggested that segmental kyphosis and reduced vertebral body height can result from asymmetrical end plate preparation and intraoperative lordotic distraction.20 In a comparative analysis of two independent studies, 158 patients who underwent cage fusion had a higher incidence of adjacent-segment disease and required more treatments for pain than did 74 patients implanted with the Bryan disc.21 Heterotopic ossification was reported in approximately 18% of a subset of 90 patients from the European Bryan disc study.22 A prospective pilot study of 15 patients implanted with the Prestige I artificial disc reported improvements in pain scores, physical functioning, and quality of life in all 14 patients at 2 years follow-up. Radiographic evaluation at 2 years indicated that all artificial discs were stable in the intervertebral space, and in all cases, flexion, extension, and translational motion were preserved.27 Four-year follow-up of the 14 patients in the study showed that improvements in pain scores, physical functioning, and quality of life were maintained. There was no evidence of adjacent segment cervical degenerative disc disease upon radiographic evaluation.28 Complications and postprocedural adverse events associated with the Prestige I disc included pain on neck extension, transient hoarseness, progressive myelopathy, and recurrent brachialgia. Early results from a prospective, randomized controlled trial of 55 patients comparing the efficacy and safety of treatment with the Prestige II artificial disc with anterior cervical fusion were reported by Porchet.29 Outcomes at 1 year for 37 patients and at 2 years for 9 patients suggest that artificial cervical disc replacement with the Prestige II is comparable to or better than fusion in relieving pain and other cervical degenerative disc disease symptoms while preserving motion at the treated disc level. In those patients receiving fusion, 19 adverse events were reported, and in those patients receiving artificial disc replacement, 17 adverse events were reported. Adverse events associated with the Prestige II disc included residual neck and shoulder pain, transient recurrent palsy, and temporary dysphagia. The Bryan cervical disc system has been in clinical use in Europe for more than 5 years, but no randomized controlled trials have been published and clinical results from fewer than 200 patients have been reported as small prospective studies and case series. The Prestige cervical disc has been in clinical use in Europe for more than 10 years, but clinical results from fewer than 100 patients have been reported in only one small prospective pilot study and one randomized controlled trial. Preliminary evidence suggests that artificial disc replacement at the cervical level relieves pain, improves functioning, and preserves cervical spine mobility in follow-up studies of 1 to 4 years. Studies evaluating the long term effectiveness and durability are necessary. Payment Guidelines:
CPT Code Description
0092T Total disc arthroplasty (artificial disc), anterior approach, including diskectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), each additional interspace, cervical (List separately in addition to code for primary procedure)
0095T Removal of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical (List separately in addition to code for primary procedure)
0098T Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical (List separately in addition to code for primary procedure)
0163T Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), each additional interspace, lumbar (List separately in addition to code for primary procedure)
0164T Removal of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, lumbar (List separately in addition to code for primary procedure)
0165T Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, lumbar (List separately in addition to code for primary procedure)
22856 Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), single interspace, cervical
22857 Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), single interspace, lumbar
22861 Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace, cervical
22862 Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace, lumbar
22864 Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace, cervical
22865 Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace, lumbar
HCPCS Code Description
L8699 Prosthetic implant, not otherwise specified
References:

1. American Medical Association. Healthcare Common Procedure Coding System. Medicare's National Level II Codes HCPCS 2009. AMA Press, 2008.
2. ECRI Health Technology Forecast, Artificial Intervertebral Disc Replacement for Degenerative Disc Disease, November 18, 2004.
3. FDA Approval http://www.fda.gov/bbs/topics/ANSWER.../ANS01320.html
4. Medicare Legal Review, April 15, 2004.
5. Guyer, R, McAffe P, Hochschuler S, Blumenthal S, Fedder I. 2004. Prospective randomized study of the Charite artificial disc: data from two investigational centers. The Spine Journal, 4 (6): 252S-259S.
6. Geisler, F, Blumenthal S, Guyer R, McAfee P, Regan J et al. 2004. Journal of Neurosurgery. (Spine 2) 1: 143-154.
7. Huang R, Sandhu H. 2004. The current status of lumbar total disc replacement. Orthopedic Clinics of North America, 35: 33-42.
8. Caspi I, Levinkopf M, Nerubay J. 2003. Results of lumbar disk prosthesis after a follow-up period of 48 months. The Israel Medical Association Journal, 5(1): 9-11.
9. 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.
10. 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.
11. National Institute for Clinical Excellence (NICE). Interventional procedures consultation document-prosthetic intervertebral disc replacement. London, UK: NICE; October 2003.
12. American Medical Association. Current Procedural Terminology: CPT 2009, Professional Edition. AMA Press, 2008.
13. Empire Medicare Services - Medicare Information Resource (Part A & B Combined). "Lumbar Artificial Disc Replacement (LADR)." MIR-2006-8AB, August 2006. Retrieved August 1, 2007.
14. Empire Medicare Services - Medicare Information Resource - (Part B). "Coding Change for Lumbar Artificial Disc Replacement (LADR)." MIR-2007-3AB, March 2007. Retrieved August 1, 2007.
15. Medicare Learning Network (MLN) Matters. "Coding Change for Lumbar Artificial Disc Replacement (LADR)." MLN Matters Number MM5462. Effective January 1, 2007. Retrieved August 1, 2007.
16. U.S. Food and Drug Administration. CDRH Consumer Information. New Device Approval. ProDisc-C Total Disc Replacement - P070001. December 21, 2007. Retrieved March 3, 2008.
17. Blumenthal S, McAfee PC, Guyer RD, et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the ChariteTM artificial disc versus lumbar fusion. Part I: Evaluation of clinical outcome. Spine July 2005;30(14):1565-1575
18. McAfee P, Cunningham B, Holsapple G, et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the ChariteTM artificial disc versus lumbar fusion. Part II: Evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine July 2005;30(14):1576-1583.
19. Lemaire JP, Carrier H, Ali EHS, et al. Clinical and radiological outcomes with the ChariteTM artificial disc: a 10-year minimum follow-up. J Spinal Disord Tech August 2005:18(4);353-359.
20. Cinotti G, David T, Postacchini F. Results of disc prosthesis after a minimum follow-up period of 2 years. Spine. 1996;21(8):995-1000.
21. Lemaire JP, Skalli W, Lavaste F, et al. Intervertebral disc prosthesis. Results and prospects for the year 2000. Clin Orthop. 1997;337:64-76.
22. 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.
23. Sott AH, Harrison DJ. Increasing age does not affect good outcome after lumbar disc replacement. Int Orthop. 2000;24(1):50-53.
24. Mayer HM, Wiechert K. Microsurgical anterior approaches to the lumbar spine for interbody fusion and total disc replacement. Neurosurgery. 2002;51(5 Suppl):159-165.
25. Food and Drug Administration (FDA) [Web site]. Center for devices and radiological health. Available at: http://www.fda.gov/cdrh/pdf4/p040006a.pdf. Accessed August 15, 2006.
26. Food and Drug Administration (FDA) [Web site]. Center for devices and radiological health. Available at: http://www.fda.gov/cdrh/mda/docs/p050010. html Accessed August 16, 2006.
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Resources:

HAYES, Inc. Medical Technology DirectoryTM. Laser Discectomy. July 2002. HAYES, Inc. Technology Assessment. Artificial Total Disc Replacement for the Lumbar Spine. September 2003. ECRI TARGET Report #852: Artificial intervertebral disc replacement for lumbar degenerative disc disease. February 2006. McAfee PC. Comments on the van Ooij article, Letter to the editor. J Spinal Disord Tech. 2004;00(0):1-2. Hayes, Inc. ChariteTM Artificial disc (DePuy Spine Inc.) for degenerative disc disease. April 3, 2006. Hayes, Inc. Bryan® cervical disc system (Medtronic Sofamor Danek) for degenerative disc disease. June 13, 2005. Hayes, Inc. ProDisc®artificial lumbar disc for single-level and multiple-level degenerative disc disease (DDD). May 18, 2006. Hayes, Inc. PrestigeTM cervical disc system (Medtronic Sofamor Danek) for degenerative disc disease. August 19, 2005. ECRI. Artificial intervertebral disc replacement for cervical degenerative disc disease. June 15, 2006.

Effective Date: January 1, 2009





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