Spinal Orthoses: Thoracic-Lumbar-Sacral (TLSO), Lumbar-Sacral (LSO), and Lumbar Form
<!DOCTYPE html> <body><h4></h4> <h4>Subject:</h4> <h4>Description</h4><p>This document addresses the use of thoracic-lumbar-sacral (TLSO), lumbar-sacral (LSO), and lumbar spinal orthoses. These types of devices are back braces, which are used for many different purposes, including the treatment of spinal column deformities, trauma, and back pain due to a variety of etiologies. This document addresses the use of back braces that are designed to immobilize or support various levels of the spine to treat back conditions.</p><p><strong>Note:</strong> For information regarding the use of self-operated spinal unloading devices, including, but not limited to, gravity-dependent and pneumatic devices for the treatment of back pain, please see:</p><ul> <li><span> DME.00025 Self-Operated Spinal Unloading Devices</span></li></ul><h4>Clinical Indications</h4><p><strong>Medically Necessary:</strong></p><p>The use of <em>prefabricated</em> thoracic-lumbar-sacral orthoses (TLSO), lumbar-sacral orthoses (LSO) and lumbar orthoses is considered <strong>medically necessary</strong> when <strong>any </strong>of the following conditions are met:</p><ol> <li>To reduce pain by restricting mobility of the trunk; <strong>or</strong></li> <li>To facilitate healing following an injury to the spine or related soft tissues; <strong>or</strong></li> <li>To facilitate healing following a surgical procedure on the spine or related soft tissue; <strong>or</strong></li> <li>To otherwise support weak spinal muscles.</li></ol><p><em>Custom fitted prefabricated</em> spinal orthoses are considered <strong>medically necessary </strong>for the following indications:</p><ol> <li>Any of the conditions listed above for prefabricated devices; <strong>and</strong></li> <li>The treatment of spinal deformity, including but not limited to scoliosis and kyphosis.</li></ol><p class="MsoPlainText"><em>Custom fabricated or custom molded</em> spinal orthoses are considered <strong>medically necessary</strong> when all the criteria below are met:</p><ol> <li class="MsoPlainText">The brace is prescribed for the treatment of a spinal deformity in a skeletally immature individual (for example, scoliosis); <strong>and</strong></li> <li class="MsoPlainText">The criteria above for custom fitted devices have been met; <strong>and</strong></li> <li class="MsoPlainText">The individual has an underlying deformity or body somatotype which would preclude the use of a prefabricated device.</li></ol><p class="MsoPlainText"><strong>Not Medically Necessary: </strong></p><p style="text-align:justify">The use of any type of thoracic-lumbar-sacral orthoses (TLSO), lumbar-sacral orthoses (LSO) or lumbar orthoses is considered <strong>not medically necessary</strong> when the medical necessity criteria above have not been met, including but not limited to all other conditions.</p><p style="text-align:justify">An upgrade would be considered a deluxe Durable Medical Equipment (DME) item and considered <strong>not medically necessary</strong> when its primary purpose is to allow the individual to perform leisure or recreational activities or includes comfort, luxury, or convenience features, or a feature which exceeds that which is considered medically necessary to treat the individual’s condition.</p><h4>Coding</h4><p class="MsoBodyText2"><em>The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.</em></p><p><strong>When services may be Medically Necessary when criteria are met:</strong></p><h4>HCPCS</h4><p><strong>When services are Not Medically Necessary:</strong><br/>For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.</p><h4>Discussion/General Information</h4><p>Thoracic-lumbar-sacral orthoses (TLSO) and lumbar-sacral orthoses (LSO) have the following characteristics:</p><ol> <li>Used to immobilize the specified areas of the spine;</li> <li>Intimate fit and generally designed to be worn under clothing;</li> <li>Not specifically designed for individuals in wheelchairs.</li></ol><p style="text-align:justify">For an item to be classified as a TLSO, the posterior portion of the brace must extend from the sacrococcygeal junction to just inferior to the scapular spine. This excludes elastic or equal shoulder straps or other strapping. The anterior must, at a minimum, extend from the symphysis pubis to the xiphoid process. Some TLSOs may require the anterior portion to extend up to the sternal notch.</p><p style="text-align:justify">A spinal orthosis can be designed to control gross movement of the trunk and intersegmental motion of the vertebrae in one or more planes of motion: lateral/flexion (side bending) in the coronal/frontal plane, flexion (forward bending) or extension (backward bending) in the sagittal plane, and axial rotation (twisting) in the transverse plane. Each type of movement is controlled by a placement of specific types of brace sections:</p><ul> <li>Sagittal control is achieved by a rigid posterior panel.</li> <li>Coronal control is achieved by a rigid panel in the mid-axillary line which is either an integral part of a posterior or anterior panel or a separate panel.</li> <li>Transverse control is achieved by one of several possible structural features: <ul> <li>A rigid panel in the upper sternal area which is an integral part of an anterior shell; or</li> <li>A rigid panel in the upper sternal area which is rigidly attached to a rigid abdominal or posterior panel; or</li> <li>Rigid extensions from a rigid posterior panel to the upper anterior chest bilaterally.</li> </ul> </li></ul><p style="text-align:justify">The documentation must show that the brace will immobilize the specific areas of the spine that are being treated. If the product does not provide control of motion in one or more planes or does not provide intracavitary pressure, then the item is not considered a spinal orthosis.</p><p style="text-align:justify">A <em>prefabricated</em> orthosis is one that is manufactured in quantity without a specific individual in mind. Prefabricated spinal braces may not require the placement or adjustment by a trained orthotist. Examples of prefabricated orthoses include lumbosacral corsets, Knight spinal braces, and the CASH (cruciform anterior spinal hyperextension) brace.</p><p>A <em>custom</em> <em>fitted</em> orthosis is a particular type of prefabricated orthosis which is manufactured in quantity without a specific individual in mind, typically as a plastic torso shell, which has been trimmed, bent, molded (with or without heat), or otherwise modified for use by an appropriately licensed and trained medical professional subsequent to the taking of appropriate body measurements. An orthosis that is assembled from prefabricated components is considered prefabricated. </p><p style="text-align:justify"><em>A preformed orthosis</em> is considered prefabricated even if it requires the attachment of straps and/or the addition of a lining and/or other finishing work. Multiple measurements of the body part may be taken to determine which stock size of a prefabricated orthosis will provide the best fit. An orthosis that is assembled from prefabricated components is considered prefabricated. Examples include the Milwaukee scoliosis brace, the Boston scoliosis brace, the Charleston scoliosis brace, and the Wilmington brace. Any orthosis that does not meet the definition of a custom fabricated orthosis is considered prefabricated.</p><p>A <em>custom fabricated</em> or <em>custom molded</em> orthosis is one which is individually made for a specific individual by a trained medical professional starting with basic materials including, but not limited to plastic, metal, leather, or cloth. It involves substantial work, such as vacuum forming, cutting, molding, sewing, etc. It involves more than trimming, bending, or making other modifications to a substantially prefabricated plastic shell. A molded-to-individual orthosis is a specific type of custom fabricated or molded orthosis in which an impression of the specific body part is made by a trained medical professional using one of several methods, including plaster casting, anthropometric measurements, or computerized modeling. These methods are all used to create a model of the individual that is used to make a positive model of the body part being fitted with an orthosis. This positive model is used to custom fit a prefabricated orthosis.</p><p>In a guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis that was last revised in 2011, the North American Spine Society (NASS) stated, “The use of a lumbosacral corset is suggested to increase walking distance and decrease pain in patients with lumbar spinal stenosis. There is no evidence that results are sustained once the brace is removed.” A 2020 NASS guideline on the diagnosis and treatment of low back pain stated that, “There is conflicting evidence that bracing results in improvements in pain and function in patients with subacute low back pain.”</p><p>A systematic review of literature performed by McAviney and colleagues (2020) assessed research regarding the use of spinal orthoses by adults with idiopathic or degenerative scoliosis. Their search identified 10 studies that had outcomes relating to these forms of scoliosis, 4 case reports and 6 cohort studies. They found no randomized or other controlled trials. Of those that included an assessment for pain, all reported either modest or significant pain reduction after the application of a spinal orthosis. The use of a variety of brace designs in this study limits the ability to draw conclusions about the benefits of any one design compared to others.</p><p>Two systematic reviews published in 2020 assessed studies on the use of spinal orthoses for osteoporotic fractures (Hofler, 2020; Kweh, 2020). Of the seven studies that met criteria for review by Kweh and colleagues, four were randomized controlled trials. The studies they reviewed found the use of spinal orthoses benefited individuals diagnosed with osteoporotic fractures. Hofler and colleagues included 16 studies in their review, five of which were randomized controlled trials (RCT). Of the RCTs, three overlapped with those reviewed by Kweh and colleagues, and two demonstrated that the use of spinal orthoses benefited individuals diagnosed with osteoporotic fractures.</p><h4>References</h4><p style="text-align:justify"><strong>Peer Reviewed Publications:</strong></p><ol> <li class="NUMBEREDBULLET">Anthony A, Zeller R, Evans C, Dermott JA. Adolescent idiopathic scoliosis detection and referral trends: impact treatment options. Spine Deform. 2021; (9):75–84.</li> <li class="NUMBEREDBULLET">Climent JM, Sanchez J. Impact of the type of brace on the quality of life of adolescents with spine deformities. Spine (Phila Pa 1976). 1999; 24(18):1903-1908.</li> <li>Coillard C, Leroux MA, Zabjek KF, Rivard CH. SpineCor-a non-rigid brace for the treatment of idiopathic scoliosis: post-treatment results. Eur Spine J. 2003; 12(2):141-148.</li> <li class="MsoHeader">Corradin M, Canavese F, Dimeglio A, Dubousset J. Cervical sagittal alignment variations in adolescent idiopathic scoliosis patients treated with thoraco-lumbo-sacral orthosis. Eur Spine J. 2017; 26(4):1217-1224.</li> <li class="MsoHeader">Gabos PG, Bojescul JA, Bowen JR, et al. Long-term follow-up of female patients with idiopathic scoliosis treated with the Wilmington orthosis. J Bone Joint Surg Am. 2004; 86-A(9):1891-1899.</li> <li>Gepstein R, Leitner Y, Zohar E, et al. Effectiveness of the Charleston bending brace in the treatment of single-curve idiopathic scoliosis. J Pediatr Orthop. 2002; 22(1):84-87.</li> <li>Guo J, Lam TP, Wong MS, et al. A prospective randomized controlled study on the treatment outcome of SpineCor brace versus rigid brace for adolescent idiopathic scoliosis with follow-up according to the SRS standardized criteria. Eur Spine J. 2014; 23(12):2650-2657.</li> <li>Gutman G, Benoit M, Joncas J, et al. The effectiveness of the SpineCor brace for the conservative treatment of adolescent idiopathic scoliosis. Comparison with the Boston brace. Spine J. 2016; 16(5):626-631.</li> <li>Hofler RC, Jones GA. Bracing for acute and subacute osteoporotic compression fractures: a systematic review of the literature. World Neurosurg. 2020; 141: e453-e460</li> <li>Howard A, Wright JG, Hedden D. A comparative study of TLSO, Charleston, and Milwaukee braces for idiopathic scoliosis. Spine (Phila Pa 1976). 1998; 23(22):2404-2411.</li> <li>Janicki JA, Poe-Kochert C, Armstrong DG, et al. A comparison of the thoracolumbosacral orthoses and providence orthosis in the treatment of adolescent idiopathic scoliosis: results using the new SRS inclusion and assessment criteria for bracing studies. J Pediatr Orthop. 2007; 27(4): 369-374.</li> <li>Katz DE, Richards BS, Browne RH, Herring JA. A comparison between the Boston brace and the Charleston bending brace in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 1997; 22(12):1302-1312.</li> <li>Kweh BTS, Lee HQ, Tan T, et al. The role of spinal orthoses in osteoporotic vertebral fractures of the elderly population (age 60 years or older): systematic review. Global Spine J. 2021; 11(6):975-987.</li> <li>Lou E, Hill D, Raso J, et al. Smart brace versus standard rigid brace for the treatment of scoliosis: a pilot study. Stud Health Technol Inform. 2012; 176: 338-341.</li> <li>McAviney J, Mee J, Fazalbhoy A, et al. A systematic literature review of spinal brace/orthosis treatment for adults with scoliosis between 1967 and 2018: clinical outcomes and harms data. BMC Musculoskelet Disord. 2020; 21(1):87.</li> <li class="MsoHeader">Palazzo C, Montigny JP, Barbot F, et al. Effects of bracing in adult with scoliosis: a retrospective study. Arch Phys Med Rehabil. 2017; 98(1):187-190.</li> <li class="MsoHeader">Plewka B, Sibinski M, Synder M, et al. Clinical assessment of the efficacy of SpineCor brace in the correction of postural deformities in the course of idiopathic scoliosis. Pol Orthop Traumatol. 2013; 78: 85-89.</li> <li class="MsoHeader">Resnick DK, Choudhri TF, Dailey AT, et al.; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 14: brace therapy as an adjunct to or substitute for lumbar fusion. J Neurosurg Spine. 2005; 2(6):716-724. </li> <li>Rowe DE, Bernstein SM, Riddic MF, et al. A meta-analysis of the efficacy of non-operative treatments for idiopathic scoliosis. J Bone Joint Surg Am. 1997; 79(5):664-674.</li> <li>Rowe DE. Results of Charleston Bracing in skeletally immature patients with idiopathic scoliosis. J Pediatr Orthop. 2002; 22(4):555.</li> <li>Shindle MK, Khanna AJ, Bhatnagar R, Sponseller PD. Adolescent idiopathic scoliosis: modern management guidelines. J Surg Orthop Adv. 2006; 15(1):43-52.</li> <li>Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013; 369(16):1512-1521.</li> <li>Wong MS, Cheng JC, Lam TP, et al. The effect of rigid versus flexible spinal orthosis on the clinical efficacy and acceptance of the patients with adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2008; 33(12):1360-1365.</li> <li>Yee AJ, Yoo JU, Marsolais EB, et al. Use of a postoperative lumbar corset after lumbar spinal arthrodesis for degenerative conditions of the spine. A prospective randomized trial. J Bone Joint Surg Am. 2008; 90(10):2062-2068.</li></ol><p style="text-align:justify"><strong>Government Agency, Medical Society, and Other Authoritative Publications:</strong></p><ol> <li class="MsoHeader">American Academy of Orthopedic Surgeons (AAOS). Idiopathic scoliosis in children and adolescents. 2015; last reviewed April 2021. Available at: <span>https://orthoinfo.aaos.org/en/diseases--conditions/idiopathic-scoliosis-in-children-and-adolescents/</span>. Accessed on February 11, 2023.</li> <li class="MsoHeader">Centers for Medicare and Medicaid Services. National Coverage Determination for Durable Medical Equipment Reference List. NCD #280.1. Effective May 5, 2005. Available at: <span>https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=190&ncdver=2&bc=0</span>. Accessed on February 11, 2023.</li> <li>North American Spine Society (NASS). Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care. Available at: <span>https://www.spine.org/Research-Clinical-Care/Quality-Improvement/Clinical-Guidelines</span>. Accessed on February 11, 2023. <ul style="list-style-type:disc"> <li>Diagnosis and Treatment of Low Back Pain. Revised 2020.</li> <li>Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis. Revised 2011.</li> </ul> </li> <li class="MsoHeader">Qaseem A, Wilt TJ, McLean RM, Forciea MA.; Clinical guidelines Committee of the American College of Physicians. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017; 166(7):514-530.</li></ol><h4>Index</h4><p class="MsoPlainText">Body Socks<br/>Boston Braces<br/>Charleston Braces<br/>Copes Scoliosis Brace<br/>Lumbar Orthoses<br/>Lumbar-Sacral Orthoses (LSO)<br/>Milwaukee Braces<br/>Providence Scoliosis System<br/>Scoliosis Braces<br/>SpineCor Dynamic Corrective Brace<br/>Thoracic-Lumbar-Sacral Orthoses (TLSO)<br/>Trunk Support Devices<br/>Wilmington Braces</p><p style="text-align:justify"><strong>The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.</strong></p><h4>History</h4><h4>Status</h4><h4>Pre-Merger Organizations</h4><p> </p><hr/><p>Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card.</p><p>Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan’s or line of business’s members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner.</p><p>No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.</p><p>© CPT Only - American Medical Association</p></body>