Clinical UM Guideline


Subject:  Spinal Orthoses: Thoracic-Lumbar-Sacral (TLSO), Lumbar-Sacral (LSO), and Lumbar
Guideline #:  CG-OR-PR-06Current Effective Date:  06/28/2016
Status:RevisedLast Review Date:  05/05/2016

Description

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 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.

Note: 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:

Clinical Indications

Medically Necessary:

The use of prefabricated thoracic-lumbar-sacral orthoses (TLSO), lumbar-sacral orthoses (LSO) and lumbar orthoses is considered medically necessary when any of the following conditions are met:

  1. To reduce pain by restricting mobility of the trunk; or
  2. To facilitate healing following an injury to the spine or related soft tissues; or
  3. To facilitate healing following a surgical procedure on the spine or related soft tissue; or
  4. To otherwise support weak spinal muscles.

Custom fitted prefabricated spinal orthoses are considered medically necessary for the following indications:

  1. Any of the conditions listed above for prefabricated devices; and
  2. The treatment of spinal deformity, including but not limited to scoliosis and kyphosis.

Custom fabricated or custom molded spinal orthoses are considered medically necessary when all the criteria below are met:

  1. The brace is prescribed for the treatment of a spinal deformity in a skeletally immature individual (for example, scoliosis); and
  2. The criteria above for custom fitted devices have been met; and
  3. The individual has an underlying deformity or body somatotype which would preclude the use of a prefabricated device.

Not Medically Necessary: 

The use of any type of thoracic-lumbar-sacral orthoses (TLSO), lumbar-sacral orthoses (LSO) or lumbar orthoses is considered not medically necessary when the medical necessity criteria above have not been met, including but not limited to all other conditions.

An upgrade would be considered a deluxe Durable Medical Equipment (DME) item and considered not medically necessary 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.

Coding

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. 

HCPCS 
 Orthoses
L0450-L0492Thoracic-lumbar-sacral-orthoses (TLSO) [includes codes L0450, L0452, L0454, L0455, L0456, L0457, L0458, L0460, L0462, L0464, L0466, L0467, L0468, L0469, L0470, L0472, L0480, L0482, L0484, L0486, L0488, L0490, L0491, L0492]
L0625-L0627Lumbar orthoses [includes codes L0625, L0626, L0627]
L0628-L0640Lumbar-sacral orthoses (LSO) [includes codes L0628, L0629, L0630, L0631, L0632, L0633, L0634, L0635, L0636, L0637, L0638, L0639, L0640]
L0641-L0642Lumbar orthoses [includes codes L0641, L0642]
L0643-L0651Lumbar-sacral orthoses (LSO) [includes codes L0643, L0648, L0649, L0650, L0651]
L1000-L1005Scoliosis procedures; cervical-thoracic-lumbar-sacral (CTLSO) orthotic devices [includes codes L1000, L1001, L1005]
L1200Scoliosis procedures, thoracic-lumbar-sacral (TLSO) orthosis (low profile), inclusive of furnishing initial orthosis only
L1300Other scoliosis procedure, body jacket molded to patient model
L1310Other scoliosis procedure, postoperative body jacket
L1499Spinal orthosis, not otherwise specified
 Additions/Accessories
L0970-L0982Additions to spinal orthoses [includes codes L0970, L0972, L0974, L0976, L0978, L0980, L0982]
L0999Addition to spinal orthosis, NOS
L1010-L1120Additions to scoliosis CTLSO [includes codes L1010, L1020, L1025, L1030, L1040, L1050, L1060, L1070, L1080, L1085, L1090, L1100, L1110, L1120]
L1210-L1290Additions to scoliosis TLSO (low profile) [includes codes L1210, L1220, L1230, L1240, L1250, L1260, L1270, L1280, L1290]
  
ICD-10 Diagnosis 
 All diagnoses
  
Discussion/General Information

Thoracic-lumbar-sacral orthoses (TLSO) and lumbar-sacral orthoses (LSO) have the following characteristics:

  1. Used to immobilize the specified areas of the spine
  2. Intimate fit and generally designed to be worn under clothing
  3. Not specifically designed for individuals in wheelchairs

For an item to be classified as a TLSO, the posterior portion of the brace must extend from the sacrococcygeal junction to just inferior of 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. Some TLSO's may require the anterior portion to extend up to the sternal notch.

A spinal orthosis can be designed to control gross movement of the trunk and intersegmental motion of the vertebrae in one of 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:

The documentation must show that the brace will immobilize the specific areas of the spine that is being treated.

A prefabricated orthosis is one which 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.  

A custom fitted 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 appropriate licensed and trained medical professional subsequent to the taking of appropriate body measurements. An orthosis that is assembled from prefabricated components is considered prefabricated.  

A preformed orthosis 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.

A custom fabricated or custom molded 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.

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.

References

Peer Reviewed Publications:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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. 
  8. 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.
  9. Rowe DE. Results of Charleston Bracing in skeletally immature patients with idiopathic scoliosis. J Pediatr Orthop. 2002; 22(4):555.
  10. Shindle MK, Khanna AJ, Bhatnagar R, Sponseller PD. Adolescent idiopathic scoliosis: modern management guidelines. J Surg Orthop Adv. 2006; 15(1):43-52.
  11. 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.
  12. 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. 

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Centers for Medicare and Medicaid Services. National Coverage Determination for Durable Medical Equipment Reference List. NCD #280.1. Effective May 5, 2005. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on February 24, 2016.
Index

Body Socks
Boston Braces
Charleston Braces
Copes Scoliosis Brace
Lumbar Orthoses
Lumbar-Sacral Orthoses (LSO)
Milwaukee Braces
Providence Scoliosis System
Scoliosis Braces
SpineCor Dynamic Corrective Brace
Thoracic-Lumbar-Sacral Orthoses (TLSO)
Trunk Support Devices
Wilmington Braces

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.

History
StatusDateAction
Revised05/05/2016Medical Policy & Technology Assessment Committee (MPTAC) review. Clarified the medically necessary statement to address the specific types of devices available. Clarified the necessary statement for custom fitted prefabricated braces to state that criteria for a prefabricated brace must also be met in addition to the criteria requiring underlying deformity or body somatotype which would preclude the use of a prefabricated brace. Added criteria to custom fabricated or custom molded spinal orthoses to require that the brace is prescribed for the treatment of a spinal deformity in a skeletally immature individual (for example, scoliosis). Updated Background section.
Reviewed02/04/2016MPTAC review. Updated Discussion section. Removed ICD-9 codes from Coding section.
Reviewed02/05/2015MPTAC review.
Reviewed02/13/2014MPTAC review. Changed document # from CG-DME-11 to CG-OR-PR-06. Updated Reference section.
 01/01/2014Updated Coding section with 01/01/2014 HCPCS changes.
Reviewed02/14/2013MPTAC review. 
Reviewed02/16/2012MPTAC review. 
Reviewed02/17/2011MPTAC review. 
Reviewed02/25/2010MPTAC review. 
Reviewed02/26/2009MPTAC review. Coding updated.
Reviewed02/21/2008MPTAC review. 
Reviewed03/08/2007MPTAC review. Updated reference section. No change to clinical indications. Coding updated; removed HCPCS K0618, K0619, K0634-K0636, K0637-K0649 deleted 12/31/2005.
New03/23/2006MPTAC review. Initial document development. 
Pre-Merger Organizations

Last Review Date

Document Number

Title

 

Anthem Connecticut

10/01/2004

 CT Durable Medical Equipment Coverage Criteria Guidelines: Spinal Orthoses: Thoracic-Lumbar-Sacral Orthoses (TLSO) and Lumbar-Sacral Orthorses (LSO) (Section J)
Anthem West

10/29/2004

DME.705West regional MDE Policy: Spinal Orthotics, TLSO and LSO
Anthem MidWest

04/05/2005

DME.013Midwest Medical Review and Utilization Management Criteria: Spinal Othoses: Thoracic-Lumbar-Sacral Orthoses (TLSO) and Lumbar-Sacral Orthorses (LSO)
WellPoint Health Networks, Inc.

 

 None