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Medical Policy: 07.01.35
Original Effective Date: January 2007
Reviewed: June 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Interspinous implants are intended to restrict painful motion while otherwise enabling normal motion. The devices, also known as spacers, distract the spinous processes and restrict extension. Theoretically, this enlarges the neural foramen in patients with spinal stenosis and neurogenic claudication. The spacer is inserted between the spinous processes through a small incision. The supraspinous ligament is maintained and assists in holding the implant in place.
In November 2005, the X-STOP® Interspinous Process Decompression System was approved by the Food and Drug Administration (FDA) for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. It is approved for those who have had a regimen of at least six months of non-operative treatment and who have relief of their pain when in flexion. The device is approved for implantation at one or two lumbar levels in patients whose condition warrants surgery at no more than two levels.
There is insufficient evidence in the peer-reviewed medical literature to demonstrate the long-term safety and efficacy of interspinous distraction devices and the durability of the devices. Randomized controlled trials are needed that compare the use of this device with traditional medical and surgical treatment of lumbar spinal stenosis.
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Prior Approval:
Not applicable
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Policy:
Interspinous distraction devices are considered investigational.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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CPT 0171T Insertion of posterior spinous process distraction device (including necessary removal of bone or ligament for insertion and imaging guidance), lumbar; single level
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CPT 0172T Insertion of posterior spinous process distraction device (including necessary removal of bone or ligament for insertion and imaging guidance), lumbar; each additional level (List separately in addition to code for primary procedure)
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Selected References:
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Zucherman JR, Hsu KY, Hartjen CA et al. A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine. 2005;30(12):1351-8.
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Talwar V, Lindsey DP, Fredrick A et al. Insertion loads of the X STOP interspinous process distraction system designed to treat neurogenic intermittent claudication. Eur Spine J. 2005 May 31.
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Sengupta DK. Dynamic stabilization devices in the treatment of lower back pain. Orthop Clin North Am. 2004 Jan; 35(1):43-56.
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Lee J, Hida K, Seki T et al. An interspinous process distractor (X STOP) for lumbar spinal stenosis in elderly patients: preliminary experiences in 10 consecutive cases. J Spinal Disord Tech. 2004 Feb; 17(1):72-7.
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Richards JC, Majumdar S, Lindsey DP et al. The treatment mechanism os an interspinous process implant for lumbar neurogenic intermittent claudication. Spine. 2005;30(7): 744-49.
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Kondrashov DG, Hannibal M, Hsu KY et al. Interspinous process decompression with the X-STOP device for lumbar spinal stenosis: a 4-year follow-up study. J Spinal Disord Tech. 2006 Jul;19(5):323-7.
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AndersonPA, Tribus CB, Kitchel SH. Treatment of neurogenic claudication by interspinous decompression: application of the X STOP device in patients with lumbar degenerative spondylolisthesis. J Neurosurg Spine. 2006 Jun;4(6):463-71.
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National Institute for Clinical Excellence (NICE). Interventional procedure overview of interspinous distraction procedures for spinal stenosis causing neurogenic claudication in the lumbar spine. London, UK: NICE; 2005 Nov. Available at www.nice.org.uk.
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North American Spine Society. Evidence-based clinical guidelines for multidisciplinary spine care: Diagnosis and treatment of degenerative lumbar spinal stenosis. January 2007 Available at: http//www.spine.org/publications.cfm
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Verhoof OJ, Bron JL, Wapstra FH, van Royen BJ. High failure rate of the interspinous distraction device (X-STOP) for the treatment of lumbar spinal stenosis caused by degenerative spondylolisthesis. Eur Spine J, 2008 Feb;17(2):188-92.
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ECRI. Interspinous Process Decompression to Treat Spinal Stenosis. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2007 August 14. (ECRI Hotline Response) Also available: http://www.ecri.org.
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ECRI Institute. Interspinous process decompression to treat spinal stenosis. Plymouth Meeting (PA): ECRI Institute; 2009 Oct. 7. 11 p. [ECRI hotline response]. Also available: http://www.ecri.org.
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ECRI Institute. Interspinous process decompression to treat spinal stenosis. Plymouth Meeting (PA): ECRI Institure; 2011 Mar 17 p. 11 [ECRI hotline response]. Also available: http://www.ecri.org.
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Policy History:
Date Reason Action
June 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark 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 Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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