Subject:
Thoracic-Lumbo-Sacral Orthosis with Pneumatics
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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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.
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. For example, HCPCS codes L0450 through L0492 describe a variety of thoracic-lumbo-sacral orthoses (TLSO). 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.
Regulatory Status
According to the manufacturer, the device is considered a Class I device by the U.S. Food and Drug Administration (FDA). This classification does not require submission of clinical data regarding efficacy but only notification of the FDA prior to marketing.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
All uses of a thoracic-lumbar-sacral orthosis incorporating pneumatic inflation are considered investigational including, but not limited to, its use for intervertebral decompression therapy or as an ambulatory traction device.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for thoracic-lumbar-sacral orthosis incorporating pneumatic inflation. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
Lumbar Sacral Orthoses (LSO) and Thoracic Lumbar Sacral Orthoses (TLSO) are covered under the Medicare Braces Benefit (Social Security Act §1861(s). Spinal Orthoses: TLSO and LSO are covered when LCD L33790 and Policy Article A52500 criteria are met. For additional information and eligibility, refer to Local Coverage Determination (LCD): Spinal Orthoses: TLSO and LSO (L33790) and Policy Article A52500. Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE-SNP Coverage:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[RATIONALE: The most recent literature search was performed for the period through August 19, 2020 Following is a summary of the key literature to date.
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.(1)
Orthofix, Inc. sponsored a randomized controlled trial comparing the Orthotrac Pneumatic Vest with an EZ form brace.(2) The target enrollment was 150 patients who had been recently diagnosed with radiating leg pain from disc bulge, protrusion, or herniation. The study is listed as completed as of October 2006. A preliminary report of patients (number unreported) completing the 12-week follow-up was presented in 2003.(3) The patients, who were carefully selected to show relief from spine unloading, showed subjective improvements in lower back and leg pain that were 6- to 8-fold greater (5 to 7 points on a visual analogue scale) than observed in the group treated with the EZ brace. No further reports of this trial were found in literature searches through December 1, 2014.
In 2005, Dallolio reported on a case series of 41 patients with radicular back pain who were treated with an Orthotrac pneumatic lumbar vest, worn for 60 minutes, 3 times a day, for 5 weeks.(4) A total of 72% of patients reported symptom improvement. However, the lack of a control group limits scientific interpretation.
Summary
The absence of controlled studies of thoracic-lumbo-sacral orthosis with pneumatics precludes any conclusions regarding effectiveness for the treatment of low back pain; the device is considered investigational.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Thoracic-Lumbo-Sacral Orthosis with Pneumatics
Ambulatory Traction Device
Back Brace, Pneumatic Orthosis
Orthotrac Pneumatic Vest
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.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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