INTERSPINOUS SPACERS IN THE LUMBAR SPINE

Transcription

1 INTERSPINOUS SPACERS IN THE LUMBAR SPINE Policy Number: 2015M0017A Effective Date: July 1, 2015 Table of Contents: Page: Cross Reference Policy: POLICY DESCRIPTION COVERAGE RATIONALE/CLINICAL CONSIDERATIONS 2 2 EPIDURAL STEROID INJECTIONS FOR LOW BACK PAIN AND SCIATICA, 2012M0014A BACKGROUND 3 ARTIFICIAL INTERVERTEBRAL DISC REGULATORY STATUS 5 REPLACEMENT, 2015M0006B CLINICAL EVIDENCE 6 APPLICABLE CODES 6 SPINAL CORD STIMULATOR, 2014M0002B REFERENCES POLICY HISTORY/REVISION INFORMATION 8 10 MEDX EXTENSION MACHINE FOR NECK OR LOW BACK PAIN, 2015M0004A RADIOFREQUENCY ABLATION FOR CHRONIC SPINAL PAIN, 2013M0019A INSTRUCTIONS: Medical Policy assists in administering UCare benefits when making coverage determinations for members under our health benefit plans. When deciding coverage, all reviewers must first identify enrollee eligibility, federal and state legislation or regulatory guidance regarding benefit mandates, and the member specific Evidence of Coverage (EOC) document must be referenced prior to using the medical policies. In the event of a conflict, the enrollee's specific benefit document and federal and state legislation and regulatory guidance supersede this Medical Policy. In the absence of benefit mandates or regulatory guidance that govern the service, procedure or treatment, or when the member s EOC document is silent or not specific, medical policies help to clarify which healthcare services may or may not be covered. This Medical Policy is provided for informational purposes and does not constitute medical advice. In addition to medical policies, UCare also uses tools developed by third parties, such as the InterQual Guidelines, to assist us in administering health benefits. The InterQual Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. Other Policies and Coverage Determination Guidelines may also apply. UCare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary and to provide benefits otherwise excluded by medical policies when necessitated by operational considerations. Page. 1 of 10

2 POLICY DESCRIPTION: This policy describes the use of inter-spinous process spacer and interlaminar distraction devices (e.g., the Coflex and X Stop System) for the treatment of lumbar spinal stenosis of the lower back. Spinal stenosis, commonly seen in an aging or degenerative spine, is a narrowing of the spinal canal that causes pressure on the spinal cord and nerve roots, low back pain, neurogenic claudication (a combination of low back and leg pain, with numbness and motor weakness when standing or walking), and reduced capacity for physical activity. These devices are intended to be used in patients with moderately impaired physical function who experience relief in flexion from their symptoms of leg/buttock/groin/back pain, and had failed conservative management. The goal is to provide symptomatic relief of pain, maintain spinal motion, and reduce spine hypermobility and degeneration of adjacent segments levels. COVERAGE RATIONALE / CLINICAL CONSIDERATIONS: Interspinous process spacer devices (e.g., X-STOP, and Coflex Interlaminar Stabilization Device) are considered experimental and/or investigational for any indication, due to inadequate clinical evidence of safety and/or efficacy in published, peer-reviewed medical literature. Clinical Considerations: The Coflex device: is intended for use in skeletally mature patients with one or two-level lumbar spinal stenosis (LSS) from L1-L5, at least moderate impairment in function, relief from their symptoms of leg/buttocks/groin pain when in flexion, and a minimum of 6 months of nonoperative treatment. Implantation of the Coflex device is contraindicated in patients who have any of the following conditions (Paradigm Spine LLC, 2013): o Prior fusion or decompressive laminectomy at any index lumbar level o Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture) o Severe facet hypertrophy that requires extensive bone removal which would cause instability o Spondylolistheses Grade II o Isthmic spondylolistheses or spondylolysis o Degenerative lumbar scoliosis (Cobb angle > 25 ) o Osteoporosis o Back or leg pain of unknown etiology o Axial back pain only, with no leg, buttock, or groin pain o Morbid obesity defined as a body mass index > 40 o Active or chronic infection systemic or local o Known allergy to titanium alloys or MRI contrast agents o Cauda equine syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction Risks associated with an interlaminar stabilization device, including the Coflex interlaminar technology, include: implant malposition or incorrect orientation; allergies to implant materials; possible wear debris, implantation at the wrong spinal level; fracture of the vertebrae, spinous process, or other damage to bony structures during or after surgery; the implant may loosen, deform, break, fatigue, or move, which may necessitate another surgery to correct the problem; and Page. 2 of 10

3 instruments also may break or malfunction in use, which may cause damage to the operative site or adjacent structures. The X Stop IPD System: is intended for the treatment of neurogenic intermittent claudication due to lumbar spinal stenosis (LSS). This device is indicated for patients older than 50 years with moderate impairment of physical function who have failed to respond adequately to 6 or more months of nonoperative treatment. The X Stop IPD System is also indicated if symptoms are aggravated by spinal extension and relieved by spinal flexion, and if operative treatment is limited to one or two levels of the lumbar spine (Kyphon Inc., 2007; Medtronic Sofamor Danek USA Inc., 2011). Implantation of the X Stop IPD System is contraindicated in patients who have any of the following conditions (Kyphon Inc., 2007; Medtronic Sofamor Danek USA Inc., 2011): o o o o o Allergy to titanium or titanium alloy. Spinal anatomy or disease that would prevent implantation of the device or cause instability of the implanted prosthesis (e.g., significant instability of the lumbar spine due to degenerative or isthmic spondylolisthesis, an ankylosed segment at the affected level(s), acute fracture of the spinous process or pars interarticularis, or significant scoliosis with a Cobb angle > 25 ). Cauda equina syndrome, which is a neural compression causing neurogenic bowel or bladder dysfunction. Diagnosis of severe osteoporosis (spine or hip bone density > 2.5 standard deviations below adult normal mean and 1 fragility fracture). Active systemic infection or infection localized to the site of implantation. X Stop system-related adverse events: implant dislodgement/migration; implant not positioned correctly; fracture of the spinous process; additional surgery, which could include removal of the X Stop implant; foreign body reaction; mechanical failure of the device; and failure of the device/procedure to improve symptoms and/or function. BACKGROUND: Lumbar spinal stenosis (LSS) is a narrowing of the spinal canal that compresses the neural elements in the lower back. It is predominately caused by degenerative changes to the spine, but may also be caused by trauma, tumor, infection, or congenital defects. Degeneration of the spine leading to LSS commonly affects the elderly, resulting in functional disability and pain, in some cases severe enough to impede mobility. It is estimated that approximately 400,000 Americans, most aged 60 years or older, are afflicted with LSS (AANS, 2011). In LSS, the dural sac and nerve roots are compressed by a combination of degenerative features, including bulging of the intervertebral discs, hypertrophy of the facet joints, and thickening/buckling of the ligamentum flavum. Clinical symptoms include leg and back pain, muscular weakness, sensory disturbances, and/or difficulty walking. Symptoms can range from mild to severe, and can affect patient mobility and quality of life. Symptomatic LSS is most often associated with neurogenic intermittent claudication, which is caused by structural narrowing of the spinal canal (Lingreen and Grider, 2010). The incidence of LSS in the United States is approximately 10% of the population. As the baby boomer generation ages, it is estimated that 2.4 million persons will be affected by LSS by 2021 (Long and Whang, 2011; Shamie, 2011; Sobottke et al., 2011). LSS is diagnosed by symptoms and imaging modalities, including X-ray, computed tomography (CT), and magnetic resonance imaging (MRI). One distinguishing characteristic of LSS is that the symptoms are Page. 3 of 10

4 relieved by postural flexion, such as by sitting, squatting, or lying with bent legs. Approximately one-third of patients with LSS achieve relief from conservative treatments such as a period of rest, nonsteroidal antiinflammatory drugs (NSAIDs), opioid analgesics, muscle relaxants, corset use, and physical therapy. Epidural steroid injections may also be effective. If lower back pain does not respond adequately to conservative treatments, surgery may be required. Surgical options range from recently developed minimally invasive decompression techniques to traditional surgical laminectomy with or without fusion, hemilaminotomy, laminotomy (laminoforaminotomy), or microendoscopic decompression laminotomy (Lingreen and Grider, 2010; AANS, 2011). However, many elderly patients with LSS are inappropriate candidates for open decompression surgery due to comorbid conditions placing the patient at a high surgical risk, including heart disease, chronic pulmonary disease, rheumatoid arthritis, and osteoarthritis (Weinstein et al., 2008; Deyo et al., 2010; Lo et al., 2010; Long and Whang, 2011; Sobottke et al., 2011). Another alternative for treatment of LSS is an interspinous process distraction device. The goal of these devices is to achieve indirect decompression by increasing the interlaminar space of the stenosed level of the spine and to limit lumbar extension, thereby relieving pain (Moojen et al., 2011). The Coflex Interlaminar Stabilization device (Paradigm Spine, LLC): is a U-shaped implant manufactured from medical-grade titanium alloy, which has been designed to withstand normal physiologic loads in the spine (Errico et al., 2009; Paradigm Spine LLC, 2013). The Coflex device is intended for use in skeletally mature patients with 1- or 2-level LSS from L1-L5, at least moderate impairment in function, relief from their symptoms of leg/buttocks/groin pain when in flexion, and a minimum of 6 months of nonoperative treatment; back pain does not have to be present (Paradigm LLC, 2013). The device is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments (see Figures 1A and 1B). Interlaminar stabilization is performed after decompression of stenosis at the affected level(s) (Paradigm Spine LLC, 2013). The device is available in heights of 8, 10, 12, 14, and 16 millimeters (mm) with 2 wings on the upper and lower ends. The device is positioned using a muscle-sparing posterior midline approach and is inserted between adjacent spinous processes of the lumbar spine. Before implantation, the interspinous ligaments and their bony attachment are removed, while mobilizing and protecting the supraspinous ligament for reconstruction. Once implanted, the lateral wings are crimped towards the spinous process to improve fixation (Errico et al., 2009; Paradigm Spine LLC, 2013). The procedure requires hospitalization. Patients are usually ambulatory the day after surgery and hospital length of stay (HLOS) is approximately 3 to 7 days. Patients should avoid heavy labor for 4 weeks postoperatively and may wear a lumbar orthosis for 3 months postoperatively to facilitate healing (Cabraja et al., 2009; Park et al., 2009). The X Stop Interspinous Process Decompression (IPD) System (Medtronic Spine LLC): was developed as a minimally invasive surgery for neurogenic intermittent claudication secondary to LSS. Use of the device is intended for patients older than 50 years with moderate impairment of physical function who have failed to respond adequately to 6 months of nonoperative treatment. The X Stop device reduces spinal extension to prevent motions that induce back pain; however, the device permits spinal flexion. The device is composed of an oval spacer that is inserted between the spinous processes at the problematic level of the lumbar spine and secured by two lateral wings. The X Stop device is implanted via a lateral or posterior approach with the use of local or general anesthesia by an orthopedic surgeon or neurosurgeon. Procedural time is typically under 1 hour, and up to 2 X Stop devices may be implanted at one time. Implantation is performed as an outpatient procedure, although in some circumstances, the physician may Page. 4 of 10

5 admit the patient for overnight observation. (Kyphon Inc., 2007; Medtronic Inc., 2008; Lo et al., 2010; Yi and McPherson, 2010; Long and Whang, 2011; Moojen et al., 2011). The titanium X Stop is available in 6-, 8-, 10-, 12-, and 14-mm sizes, and X Stop PEEK is also available in a 16- mm size. The optimal size is determined by placement of a sizing distractor into the interspinous space during the surgical procedure. Patients are placed on a radiolucent table and the operative level(s) are confirmed through fluoroscopy. Procedural time is typically under 1 hour, and up to 2 X Stop devices may be implanted at one time; proper positioning of the implant may be confirmed by fluoroscopy or direct visualization. Implantation is performed as an outpatient procedure, although in some circumstances, the physician may admit the patient for overnight observation. Patients may wear a lumbosacral corset or other immobilization appliance for pain control and to expedite the healing process. Some patients may benefit from physical therapy (Kyphon Inc., 2007; Medtronic Inc., 2008; Lo et al., 2010; Yi and McPherson, 2010; Long and Whang, 2011). Clinical Alternatives: Conservative nonsurgical treatments for LSS include NSAIDs, analgesics, muscle relaxants, epidural steroids, physical therapy, and bracing. Surgical options include decompressive procedures such as laminotomy, hemilaminotomy, laminectomy, hemilaminectomy, laminoplasty, foraminotomy, and facetectomy. Patients may undergo surgical spinal fusion in addition to or instead of decompressive procedures (Yi and McPherson, 2010; Sobottke et al., 2011). REGULATORY STATUS: 1. U.S. FOOD AND DRUG ADMINISTRATION (FDA): The Coflex Interlaminar Stabilization device (Paradigm Spine LLC): is regulated by the FDA as a spinous process spacer/plate prosthesis that received approval via the premarket approval (PMA) process, which involves the most stringent regulations enforced by the FDA. The Center for Devices and Radiological Health (CDRH) issued PMA for the Coflex Interlaminar Technology on October 17, 2012 (P110008). According to the PMA Approval Order Statement: This device is indicated for use in one- or two-level lumbar stenosis from l1- l5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 month of non-operative treatment. The Coflex is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s) The Coflex -F (Paradigm Spine LLC): received 510(k) clearance (K112595) on February 13, According to the clearance summary: The Coflex -F Implant System is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (Li-SI). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade I spondylolisthesis. The X Stop IPD System: is a modified version of the device and is regulated by the FDA as a spinous process spacer/plate prosthesis. It received approval via the premarket approval (PMA) process, which involves the most stringent regulations enforced by the FDA. The Center for Devices and Radiological Page. 5 of 10

6 Health (CDRH) has issued the following approvals for X Stop models: The X Stop IPD System received PMA approval on November 21, 2005: click here. The X-Stop PEEK IPD System received PMA approval on August 8, 2006 (search P in the P Number field, then scroll to Supplement Number S002) 2. CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS): No CMS National Coverage Determination (NCD) was identified for LSS with the Coflex Interlaminar Stabilization device or the X Stop IPD System on March 21, In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers. 3. MINNESOTA DEPARTMENT OF HUMAN SERVICES (DHS): Minnesota DHS does not have a policy statement regarding artificial spinal disc replacement in its Provider Manual or other specific provider references. CLINICAL EVIDENCE: Summary: The use of various interspinous process spacer devices has been proposed as a minimally invasive alternative for treatment of pain associated with degenerative disc disease and spinal stenosis. Evidence limited; additional well-designed comparative studies are needed to determine the long-term safety, efficacy, and durability of the device. Recent evidence indicates that interspinous process spacer surgery may be associated with a higher rate of early postoperative spinous process fracture than previously reported, further raising concerns about the long term safety of these devices. Several additional devices, including the Wallis Dynamic Posterior Stabilization System and the Diam Spinal Stabilization System are being evaluated in clinical trials but have not received U.S. Food and Drug Administration (FDA) approval. There is insufficient evidence in the published medical literature to demonstrate the safety, efficacy, and long-term outcome of interspinous process spacer devices, or to determine how the use of these devices compares to alternative medical, interventional, or surgical treatment. APPLICABLE CODES: The Current Procedural Terminology (CPT ) codes and HCPCS codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other medical policies and coverage determination guidelines may apply. HCPCS Codes C1821 ICD-9 Codes Description Interspinous process distraction device (implantable) Description Spinal stenosis, other than cervical, lumbar region ICD-10 Codes 0RH008Z 0RH038Z Description Insertion of Spacer into Occipital-cervical Joint, Open Approach Insertion of Spacer into Occipital-cervical Joint, Percutaneous Approach Page. 6 of 10

7 0RH048Z 0RH108Z 0RH138Z 0RH148Z 0RH408Z 0RH438Z 0RH448Z 0RH608Z 0RH638Z 0RH648Z 0RHA08Z 0RHA38Z 0RHA48Z 0SH008Z 0SH038Z 0SH048Z 0SH308Z 0SH338Z 0SH348Z 0RP008Z 0RP038Z 0RP048Z 0RP108Z 0RP138Z 0RP148Z 0RP408Z 0RP438Z 0RP448Z 0RP608Z 0RP638Z 0RP648Z 0RPA08Z 0RPA38Z 0RPA48Z 0SP008Z 0SP038Z 0SP048Z 0SP308Z 0SP338Z 0SP348Z CPT Codes 0171T 0172T Insertion of Spacer into Occipital-cervical Joint, Percutaneous Endoscopic Approach Insertion of Spacer into Cervical Vertebral Joint, Open Approach Insertion of Spacer into Cervical Vertebral Joint, Percutaneous Approach Insertion of Spacer into Cervical Vertebral Joint, Percutaneous Endoscopic Approach Insertion of Spacer into Cervicothoracic Vertebral Joint, Open Approach Insertion of Spacer into Cervicothoracic Vertebral Joint, Percutaneous Approach Insertion of Spacer into Cervicothoracic Vertebral Joint, Percutaneous Endoscopic Approach Insertion of Spacer into Thoracic Vertebral Joint, Open Approach Insertion of Spacer into Thoracic Vertebral Joint, Percutaneous Approach Insertion of Spacer into Thoracic Vertebral Joint, Percutaneous Endoscopic Approach Insertion of Spacer into Thoracolumbar Vertebral Joint, Open Approach Insertion of Spacer into Thoracolumbar Vertebral Joint, Percutaneous Approach Insertion of Spacer into Thoracolumbar Vertebral Joint, Percutaneous Endoscopic Approach Insertion of Spacer into Lumbar Vertebral Joint, Open Approach Insertion of Spacer into Lumbar Vertebral Joint, Percutaneous Approach Insertion of Spacer into Lumbar Vertebral Joint, Percutaneous Endoscopic Approach Insertion of Spacer into Lumbosacral Joint, Open Approach Insertion of Spacer into Lumbosacral Joint, Percutaneous Approach Insertion of Spacer into Lumbosacral Joint, Percutaneous Endoscopic Approach Removal of Spacer from Occipital-cervical Joint, Open Approach Removal of Spacer from Occipital-cervical Joint, Percutaneous Approach Removal of Spacer from Occipital-cervical Joint, Percutaneous Endoscopic Approach Removal of Spacer from Cervical Vertebral Joint, Open Approach Removal of Spacer from Cervical Vertebral Joint, Percutaneous Approach Removal of Spacer from Cervical Vertebral Joint, Percutaneous Endoscopic Approach Removal of Spacer from Cervicothoracic Vertebral Joint, Open Approach Removal of Spacer from Cervicothoracic Vertebral Joint, Percutaneous Approach Removal of Spacer from Cervicothoracic Vertebral Joint, Percutaneous Endoscopic Approach Removal of Spacer from Thoracic Vertebral Joint, Open Approach Removal of Spacer from Thoracic Vertebral Joint, Percutaneous Approach Removal of Spacer from Thoracic Vertebral Joint, Percutaneous Endoscopic Approach Removal of Spacer from Thoracolumbar Vertebral Joint, Open Approach Removal of Spacer from Thoracolumbar Vertebral Joint, Percutaneous Approach Removal of Spacer from Thoracolumbar Vertebral Joint, Percutaneous Endoscopic Approach Removal of Spacer from Lumbar Vertebral Joint, Open Approach Removal of Spacer from Lumbar Vertebral Joint, Percutaneous Approach Removal of Spacer from Lumbar Vertebral Joint, Percutaneous Endoscopic Approach Removal of Spacer from Lumbosacral Joint, Open Approach Removal of Spacer from Lumbosacral Joint, Percutaneous Approach Removal of Spacer from Lumbosacral Joint, Percutaneous Endoscopic Approach Description Insertion of posterior spinous process distraction device (including necessary removal of bone or ligament for insertion and imaging guidance), lumbar; single level 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) CPT is a registered trademark of the American Medical Association. Page. 7 of 10

8 REFERENCES: 1. Hayes, Winifred S. Directory Report. X Stop Interspinous Process Decompression System (Medtronic Spine LLC) for Lumbar Spinal Stenosis. December 14, Available at: Accessed March 22, Hayes, Winifred S. Directory Report. Coflex Interlaminar Technology (Paradigm Spine) Interlaminar Stabilization Device. November 26, Available at: Accessed January 22, American Association of Neurological Surgeons (AANS). Patient Information: Lumbar Spinal Stenosis. December Available at: aspx. Accessed March 20, Auerbach JD, Zigler JD, Davis RJ, Pettine K, Yeung A. Comparative cost-effectiveness analysis of Coflex interlaminar stabilization versus posterolateral fusion for lumbar stenosis and low-grade spondylolisthesis [abstract]. International Society for the Advancement of Spine Surgery 12 th Annual Conference, Barcelona, Spain. March 20-23, Available at: Accessed March 8, Cabraja M, Abbushi A, Woiciechowsky C, Kroppenstedt S. The short- and mid-term effect of dynamic interspinous distraction in the treatment of recurrent lumbar facet joint pain. Eur Spine J. 2009;18(11): Available at: Accessed March 7, Celik H, Derincek A, Koksal I. Surgical treatment of the spinal stenosis with an interspinous distraction device: do we really restore the foraminal height? Turk Neurosurg. 2012;22(1): Available at: Accessed March 5, Credentialing Resource Center (CRC). Orthopedic surgery. Clin Privil White Pap. 2012;(149): Credentialing Resource Center (CRC). Neurological surgery. Clin Privil White Pap. 2013;(155): Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010;303(13): Available at: Accessed March 7, Errico TJ, Kamerlink JR, Quirno M, Samani J, Chomiak RJ. Survivorship of Coflex interlaminar-interspinous implant. SAS J. 2009;3(2): Kong D, Kim E, Eoh W. One-year outcome evaluation after interspinous implantation for degenerative spinal stenosis with segmental instability. J Korean Med Sci. 2007;22: Available at: Accessed March 7, Kreiner DS, Shaffer WO, Summers J, et al.; North American Spine Society (NASS). Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis: Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care. Revised Available at: Accessed March 8, Lingreen R, Grider JS. Retrospective review of patient self-reported improvement and post-procedure findings for mild (minimally invasive lumbar decompression). Pain Physician. 2010;13(6): Available at: Accessed March 5, Lo TP Jr, Salerno SS, Colohan AR. Interlaminar spacer: a review of its mechanism, application, and efficacy. World Neurosurg. 2010;74(6): Long WD III, Whang PG. Interspinous Spacers for Lumbar Spinal Stenosis. Oper Tech Orthop. 2011;21(3): Moojen WA, Arts MP, Bartels RH, Jacobs WC, Peul WC. Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: a systematic review and meta-analysis. Eur Spine J. 2011;20(10): Available at: Accessed March 8, National Institute for Health and Clinical Excellence (NICE). Interspinous distraction procedures for lumbar spinal stenosis causing neurogenic claudication. London, UK: National Institute for Health and Clinical Excellence; Interventional Procedure Guidance No Available at: Accessed March 8, Page. 8 of 10

9 18. Paradigm Spine LLC. Instructions for Use: coflex Interlaminar Technology Accessed March 7, Park SC, Yoon SH, Hong YP, Kim KJ, Chung SK, Kim HJ. Minimum 2-year follow-up result of degenerative spinal stenosis treated with interspinous U (Coflex ). J Korean Neurosurg Soc. 2009;46(4): Available at: Accessed March 7, Richter A, Halm H, Hauck M, Quante M. 2-year follow-up after decompressive surgery with and without implantation of an interspinous device for lumbar spinal stenosis-a prospective controlled study. J Spinal Disord Tech. May 24, 2012 [Epub ahead of print]. Available at: e=abstract. Accessed March 7, Shamie AN. Lumbar spinal stenosis: The growing epidemic. AAOS Now. 2011;5(5):1-5. Available at: Accessed March 5, Sobottke R, Siewe J, Kaulhausen T, Otto C, Eysel P. Interspinous spacers as treatment for lumbar stenosis. Semin Spine Surg. 2011;23(1): Weinstein JN, Tosteson TD, Lurie JD, et al.; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008;358(8): Available at: Accessed March 5, Yi X, McPherson B. Application of X STOP device in the treatment of lumbar spinal stenosis. Pain Physician. 2010;13(5):E327-E336. Available at: E336.pdf. Accessed March 8, Abrams J, Hsu K, Kondrashov D, McDermott T, Zucherman J. Treatment of Facet Cysts Associated With Neurogenic Intermittent Claudication With X-Stop. J Spinal Disord Tech. November 29, Available at: e=abstract. Accessed March 22, Anderson PA, 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;4(6): Azzazi A, Elhawary Y. Dynamic Stabilization Using X-stop Versus Transpedicular Screw Fixation in the Treatment of Lumbar Canal Stenosis; Comparative Study of the Clinical Outcome. Neurosurg Q. 2010;20(3): Barbagallo GM, Olindo G, Corbino L, Albanese V. Analysis of complications in patients treated with the X-Stop Interspinous Process Decompression System: proposal for a novel anatomic scoring system for patient selection and review of the literature. Neurosurgery. 2009;65(1): Brussee P, Hauth J, Donk RD, Verbeek AL, Bartels RH. Self-rated evaluation of outcome of the implantation of interspinous process distraction (X-Stop) for neurogenic claudication. Eur Spine J. 2008;17(2): Available at: Accessed March 22, Burnett MG, Stein SC, Bartels RH. Cost-effectiveness of current treatment strategies for lumbar spinal stenosis: nonsurgical care, laminectomy, and X-STOP. J Neurosurg Spine. 2010;13(1): Chou R, Huffman LH. Guideline for the evaluation and management of low back pain: evidence review. American Pain Society. Updated May Available at: Accessed March 22, Hsu KY, Zucherman JF, Hartjen CA, et al. Quality of life of lumbar stenosis-treated patients in whom the X STOP interspinous device was implanted. J Neurosurg Spine. 2006;5(6): Kondrashov D, Hannibal M, Hsu K, Zucherman J. X STOP versus Decompression for Neurogenic Claudication: Economic and Clinical Analysis. The Internet Journal of Minimally Invasive Spinal Technology. 2007;1(2). Available at: number-2/x-stop-versus-decompression-for-neurogenic-claudication-economic-and-clinical-analysis.html. Accessed March 22, Page. 9 of 10

10 34. Kuchta J, Sobottke R, Eysel P, Simons P. Two-year results of interspinous spacer (X-Stop) implantation in 175 patients with neurologic intermittent claudication due to lumbar spinal stenosis. Eur Spine J. 2009;18(6): Kyphon Inc. X-STOP IPD System [package insert] Available at: STOP_sellsheet.pdf. Accessed March 22, Lo TP Jr, Salerno SS, Colohan AR. Interlaminar spacer: a review of its mechanism, application, and efficacy. World Neurosurg. 2010;74(6): Medtronic Inc. Medtronic Announces Launch of X-Stop Peek IPD System for U.S. Patients Suffering from Symptoms of Lumbar Spinal Stenosis [news release]. October 14, Available at: Accessed March 22, Medtronic Sofamor Danek USA Inc. X-STOP Interspinous spacer procedure. Reimbursement Guide Available at: e.pdf. Accessed March 22, Miller LE, Block JE. Interspinous spacer implant in patients with lumbar spinal stenosis: preliminary results of a multicenter, randomized, controlled trial. Pain Res Treat. 2012;2012: North American Spine Society (NASS). Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis Available at: Accessed March 22, Rolfe KW, Zucherman JF, Kondrashov DG, Hsu KY, Nosova E. Scoliosis and interspinous decompression with the X- STOP: prospective minimum 1-year outcomes in lumbar spinal stenosis. Spine J. 2010;10(11): Siddiqui M, Smith FW, Wardlaw D. One-year results of X Stop interspinous implant for the treatment of lumbar spinal stenosis. Spine (Phila PA 1976). 2007;32(12): Skidmore G, Ackerman SJ, Bergin C, et al. Cost-effectiveness of the X-STOP interspinous spacer for lumbar spinal stenosis. Spine (Phila PA 1976). 2011;36(5):E345-E Sobottke R, Schlüter-Brust K, Kaulhausen T, et al. Interspinous implants (X Stop, Wallis, Diam) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome? Eur Spine J. 2009;18(10): Ulivieri S, Petrini C, Oliveri G. X-Stop interspinous implant for the treatment of lumbar spinal stenosis. Our experience after 50 consecutive patients. G Chir. 2010;31(5): Zucherman JF, 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 (Phila PA 1976). 2005;30(12): Zucherman JF, Hsu KY, Hartjen CA, et al. A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results. Eur Spine J. 2004;13(1): POLICY HISTORY: DATE ACTION/DESCRIPTION 03/27/2013 New Policy 2013M0017A. Reviewed and approved by the Interim Medical Policy Committee. 04/25/2013 Approved by the Interim Medical Policy Committee (IMPC). 11/15/2013 Published to UCare.org 07/01/2015 Policy Update: Added applicable ICD-10 codes to the Coding Section. The list of codes may not be all-inclusive and does not denote coverage. Policy identification number updated to 2015M0017A. Page. 10 of 10