Thoracic-Lumbo- Sacral Orthosis with Pneumatics Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 03|01|2012 POLICY LAST REVIEWED: 02/05/2025 OVERVIEW Thoracic-lumbo-sacral orthosis (TLSO) with pneumatics consists of a vest with inflatable inserts. Inflation of these expandable inserts and pressure are controlled by the patient. The device is used to unload body weight from the spine onto the iliac crests. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans Thoracic-lumbo-sacral orthosis incorporating pneumatic inflation is not covered as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Commercial Products Thoracic-lumbo-sacral orthosis incorporating pneumatic inflation is considered not medically necessary as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. COVERAGE Benefits may vary between groups/contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage. BACKGROUND A variety of back supports or braces are designed to offer stabilization and decompression as a conservative treatment for pain related to spinal disc disease and/or joint dysfunction. An orthotic that includes a pneumatic component has become commercially available, the Orthotrac Pneumatic Vest™ (manufactured by Kinesis Medical, Minneapolis, MN). Orthofix, Inc. acquired Kinesis Medical in 2000.
The pneumatic component is inflated by the patient and is designed to lift the patient’s body weight off the spine and relieve intervertebral compression. The orthotic is designed to be worn intermittently throughout the day. As with any therapy for pain, placebo-controlled trials are particularly important to document the extent of the expected placebo effect and to determine the independent contribution of the therapy itself. While the lack of published studies does not permit scientific conclusions about a pneumatic lumbar orthosis alone or in comparison to other types of back orthoses, it should be noted that the literature regarding back braces and supports is, in general, of poor quality. A meta-analysis of lumbar support devices reported that there was limited evidence that lumbar supports are more effective than no treatment of low back pain and that it was unclear if lumbar supports are more effective than other interventions for treatment of low back pain.
The absence of controlled studies of TLSO with pneumatics precludes any conclusions regarding effectiveness for the treatment of low back pain; the device is considered not medically necessary as there is no proven efficacy. Medical Coverage Policy | Thoracic-Lumbo- Sacral Orthosis with Pneumatics

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

CODING The following HCPCS code is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: E0830 Ambulatory traction device, all types, each

RELATED POLICIES None

PUBLISHED Provider Update, April 2025 Provider Update, April 2024 Provider Update, May 2023 Provider Update, July 2022 Provider Update, December 2021

REFERENCES 1.Van Tulder M, Jellema P, van Poppel M et al. Lumbar supports for prevention and treatment of low back pain. Cochrane Database Syst Rev 2000; (3):CD001823.

2. Triano J. A randomized, controlled trial of treatment for disc herniation with radiating leg pain. Available online at: http://www.clinicaltrials.gov/ct/show/NCT00220935. Last accessed September, 2011.
3. Triano J, Rogers C, Diederich J. Discopathy with leg pain: a randomized controlled trial of Orthotrac vs EZ brace. Spine J 2003; 3(5):105-6.

4. Dallolio V. Lumbar spinal decompression with a pneumatic orthosis (Orthotrac): preliminary study. Acta Neurochir Suppl 2005; 92:133-7.

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   This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS