Interspinous And Interlaminar Stabilization/Distraction .
Interspinous and Interlaminar Stabilization/DistractionDevices (Spacers)Policy Number: PG0213Last Review: 05/25/2021ADVANTAGE ELITE HMOINDIVIDUAL MARKETPLACE PROMEDICA MEDICAREPLAN PPOGUIDELINESThis policy does not certify benefits or authorization of benefits, which is designated by each individualpolicyholder contract. Paramount applies coding edits to all medical claims through coding logic softwareto evaluate the accuracy and adherence to accepted national standards. This guideline is solely forexplaining correct procedure reporting and does not imply coverage and reimbursement.SCOPEX ProfessionalX FacilityDESCRIPTIONLumbar spinal stenosis (LSS) is a narrowing of the spinal canal that compresses the neural elements in the lowerback. The resulting pain, weakness, and/or numbness in the legs is known as neurogenic intermittent claudication.Symptoms are relieved by postural flexion, such as by sitting, squatting, or lying with bent legs. Symptoms canrange from mild to severe, and can affect patient mobility and quality of life. The incidence of LSS in the UnitedStates is approximately 10% of the population. LSS is mainly related to degenerative changes, and it is estimatedthat approximately 400,000 Americans, most aged 60 years or older, are afflicted. First-line treatment forsymptomatic LSS includes conservative treatments such as rest, nonsteroidal anti-inflammatory drugs, musclerelaxants, corset use, physical therapy, and epidural steroid injections. If symptoms do not respond adequately toconservative treatments, open surgical treatments such as laminectomy or spinal fusion may be required, whichcan have serious complications and can be particularly risky for elderly patients.Interspinous and interlaminar implants (spacers) stabilize or distract the adjacent lamina and/or spinous processesand restrict extension to reduce pain in patients with lumbar spinal stenosis and neurogenic claudication. Interspinous spacers are small devices implanted between the vertebral spinous processes. After theimplantation, the device is opened or expanded to distract (open) the neural foramina and decompress thenerves. Interspinous implants are intended to restrict painful motion while otherwise enabling normalmotion. Interlaminar spacers are implanted midline between adjacent lamina and spinous processes to providedynamic stabilization either following decompression surgery or as an alternative to decompression surgery.A number of Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers) have been approved by theU.S Food and Drug Administration (FDA)Interspinous Fixation Devices (not an all-inclusive list) Affix II and Affix II Mini Spinous Process Plating System (NuVasive) Aileron Interspinous Fixation System (Life Spine) Aspen MIS Fusion System (Biomet) Aspen Spinous Process Fixation System (Lanx) Axle (X-Spine) BacFuse (Pioneer Surgical) Benefix Interspinous Fixation System Biomet Aspen fusion system BridgePoint (Alphatec) CD Horizon Spire Fixation System (Medtronic Sofamor Danek)PG0213 – 05/25/2021
Coflex-F (Paradigm Spine)Inspan (Spine Frontier)Minuteman Interspinous Interlaminar Fusion Device (Spinal Simplicity)PrimaLOK SP (OsteoMed)Octave (Life Spine)StabiLink MIS Interspinous Fixation Device (Southern Spine)SP-Fix Spinous Process Fixation System (Globus Medical)Interspinous and Interlaminar Distraction Devices (not an all-inclusive list) Aperius PercLID System (Kyphon/ Medtronic Spine) Coflex Interlaminar Technology Implant (Paradigm Spine) CoRoent Extensure (Nuvasive) DIAM Spinal Stabilization System (Medtronic Sofamor Danek) ExtenSure (Nuvasive) FLEXUS (Globus Medical) Falena Interspinous Decompression Device (Mikai Spine) Helifix Interspinous Spacer System (Alphatec Spine) In-Space (Synthes) NL-Prow Interspinous Spacer (Non-Linear Technologies) Stenofix (Synthes) Superion ISS Interspinous Spacer System (VertiFlex) Wallis System (Abbott Spine/ Zimmer Spine) X-STOP Interspinous Process Decompression (IPD) System (Kyphon/ Medtronic Spine) X-STOP PEEK Interspinous Process Decompression (IPD) System (Kyphon/ Medtronic Spine)POLICYHMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, AdvantageEffective 4/1/2021Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers) (22867-22870, C1821)require a prior authorization.COVERAGE CRITERIA:HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, AdvantageInterspinous Distraction DevicesInterspinous distraction devices (including but not limited to Coflex Interlaminar Technology Implant/CoflexIntralaminar Stabalization Devices, X-STOP Interspinous Process Decompression (IPD ) System Vertiflexinterspinous decompression spacer/Superion InterSpinous Spacer) are considered covered when the followingcoverage criteria is meet.Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers) Treatment reviewed forindications include ALL of the following: Symptomatic spinal stenosis affecting lumbar segments L1 through L5 A complete history and physical, including neurologic exam, documenting spinal stenosis clinically, andradiologically (diagnostic image(s))o Diagnostic imaging indication spinal stenosis as defined as any narrowing less than normal of theneuroforamina, lateral recess or central canalo Symptomatic spinal stenosis with demonstrated relief with lumbar spine flexion Significant mechanical back pain is present (in addition to those symptoms associated with neuralcompression) at rest and/or with movements while standing and does not have characteristics consistentwith neurogenic claudicationo Central Stenosis: Pain, cramping, weakness, tingling affecting back, buttocks and or legs unilateral or bilateral Neurogenic claudication (NIC): symptoms present with standing and activity with reliefcoming only with spine flexion or sitting (not just standing)PG0213 – 05/25/2021
Standing less than 15min Walking less than 350fto Lateral Recess stenosis Neurogenic claudication (NIC): symptoms present with standing and activity with reliefcoming only with spine flexion or sitting (not just standing) Radicular pain Acute or chronic pain Rarely weaknesso Foraminal Stenosis Radicular pain, dermatomalFailed conservative treatment with no improvement in symptoms after 12 weeks:o Oral medication, steroids and non-steroidal anti-inflammatory drugs (NSAIDs)o Epidural steroid injectionso Physical therapy, spinal manipulation therapy, cognitive behavioral therapy (CBT) or otherinterventions based on the individual’s specific presentationo Modification of activities of daily lifeContinued worsening of symptomso Symptoms present for greater than three monthso Functional impairment that is interfering with activities of daily living (meals, walking, gettingdressed, driving)Exclusionary criteria: Prior laminectomy at targeted level Prior spinal fusion/instrumentation at targeted level Medical conditions acute or chronic that would preclude safe delivery of service Morbid Obesity Failure to relieve symptoms with spine flexion. (sitting, bending forward, leaning on countertop, grocery cart) At the targeted segment(s) Spondylolisthesis greater than grade 1 Instability on flexion and extension films ( 3mm axial translation or 5degree angulation) Ankylosed segment Spinous process, pars interarticularis or lamina fracture Scoliosis with Cobb angle greater than 10% Service Osteoporosis (DEXA T-score less than 2.5)Interspinous Fixation DevicesInterspinous fixation devices (including but not limited to: Affix , Axle , BacFuse , Coflex-F , Inspan ,Screwless Fusion Devise, Spire , Lanx SFS, TOPS (Total Posterior – element System) Spinal System) areconsidered investigational for any indication, including but not limited to use: In combination with interbody fusion, or Alone for decompression in patients with spinal stenosis and or spondylolisthesisCODING/BILLING INFORMATIONThe appearance of a code in this section does not necessarily indicate coverage. Codes that are covered mayhave selection criteria that must be met. Payment for supplies may be included in payment for other servicesrendered.CPT CODESInsertion of interlaminar/interspinous process stabilization/distraction device, without fusion,22867including image guidance when performed, with open decompression, lumbar; single levelInsertion of interlaminar/interspinous process stabilization/distraction device, without fusion,22868including image guidance when performed, with open decompression, lumbar; second level (Listseparately in addition to code for primary procedure)Insertion of interlaminar/interspinous process stabilization/distraction device, without open22869decompression or fusion, including image guidance when performed, lumbar; single levelPG0213 – 05/25/2021
Insertion of interlaminar/interspinous process stabilization/distraction device, without opendecompression or fusion, including image guidance when performed, lumbar; second level (Listseparately in addition to code for primary procedure)Unlisted procedure, spine [when specified as insertion of a non-pedicle interspinous process22899fixation device]HCPCS CODEC1821Interspinous process distraction device (implantable)22870REVISION HISTORY EXPLANATIONORIGINAL EFFECTIVE DATE: 03/01/2009DateExplanation & Changes03/15/10 Updated references05/01/11 No changes Policy reviewed and updated to reflect most current clinical evidence per The Technology01/22/16Assessment Working Group (TAWG). Per Medical Director’s review of CMS A52693, the Coflex Interlaminar StabilizationDevice is non-covered.04/22/16 Policy reviewed and updated to reflect most current clinical evidence per The TechnologyAssessment Working Group (TAWG). Codes 0171T & 0172T deleted effective 12/31/16. New effective 01/01/17 codes added 22867-22870 as covered for Elite and Advantage only01/27/17with prior authorization. Policy reviewed and updated to reflect most current clinical evidence per The TechnologyAssessment Working Group (TAWG). Policy reviewed and updated to reflect most current clinical evidence per The Technology01/25/18Assessment Working Group (TAWG).12/16/2020 Medical policy placed on the new Paramount Medical Policy Format Medical policy name changed from Interspinous Process Decompression Devices, toInterspinous and Interlaminar Stabilization/Distraction Devices (Spacers) Policy updated to reflect the most current Industry Standardso HMO, PPO, Individual Marketplace Effective 4/1/2021Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers) (22867-22870,C1821) are non-covered.02/01/2021o Elite/ProMedica Medicare Plan Effective 4/1/2021Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers) (22867-22870,C1821) are non-covered.o Advantage Effective 4/1/2021Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers) (22867-22870,C1821) require a prior authorization. Criteria established for Advantage medical necessity review Medical Policy updated to support specific coverage criteria05/25/2021 Effective 04/01/2021 a prior authorization is required for procedures 22867, 22868, 22869,22870, for all product linesREFERENCES/RESOURCESCenters for Medicare and Medicaid Services, CMS Manual System and other CMS publications andservicesOhio Department of MedicaidAmerican Medical Association, Current Procedural Terminology (CPT ) and associated publications andservicesPG0213 – 05/25/2021
Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCSRelease and Code SetsHayes, Inc.Industry Standard ReviewPG0213 – 05/25/2021
May 01, 2011 · PG0213 – 05/25/2021 Coflex-F (Paradigm Spine) Inspan (Spine Frontier) Minuteman Interspinous Interlaminar Fusion Device (Spinal Simplicity) PrimaLOK SP (OsteoMed) Octave (Life Spine) StabiLink MIS Interspinous Fixation Device (Southern Spine) SP-Fix Spinous Process Fixation System (Globus Medical) Interspinous and Interlaminar Distraction Devices
Page 1 of 19 Superion InterSpinous Spacer. Caution: Federal Law restricts this device to sale by or on the order of a physician. This brochure will provide you with information about the Superion InterSpinous Spacer, a new
in whom the X STOP interspinous device was implanted Ken Y. Hsu, J Neurosurg Spine , 2006 A lti t ti d i d t i l l ti 3 A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication:
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