Coverage Policy Manual
Policy #: 2003017
Category: DME
Initiated: June 2003
Last Review: November 2023
  Spinal Unloading Devices For Treatment Of Low Back Pain (Orthotrac Pneumatic Vest)
Description:
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.
 
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/
Coverage:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Spinal unloading devices, including but not limited to gravity dependent and pneumatic devices do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, spinal unloading devices, including but not limited to gravity dependent and pneumatic devices are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
A MEDLINE literature search focusing on pneumatic lumbar orthoses did not identify published articles. 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.
 
2003 Update
A review of the peer-reviewed literature on MEDLINE from the period of 2002 through June 2003 found no published articles on pneumatic lumbar orthoses. Therefore, the policy is unchanged.
 
2009 Update
A search of the Medline database for the time period of August 2005 through February 2009 revealed one study on the Orthotrac Pneumatic Vest.  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. A total of 72% of patients reported symptom improvement.  However, the lack of a control group limits scientific interpretation.
 
No other published literature on pneumatic lumbar devices was found. The policy is unchanged.
 
2011 Update
A search of the MEDLINE database was conducted through January 2011.  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 coverage statement is unchanged.
 
2012 Update
A search of the MEDLINE database was conducted through September 2012.  There was no new information identified that would prompt a change in the coverage statement.
 
2013 Update
A search of the MEDLINE database through September 2013 did not reveal any new information that would prompt a change in the coverage statement.
 
2013 Update
A search of the MEDLINE database through September 2013 did not reveal any new information that would prompt a change in the coverage statement.
   
2014 Update
A literature search conducted through October 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2016 Update
A literature search conducted through October 2016 did not reveal any new information that would prompt a change in the coverage statement.
  
November 2017
A literature search using the MEDLINE database through October 2017 did not reveal any new literature that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through October 2018.  There was no new information identified that would prompt a change in the coverage statement.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
L0450Tlso, flexible, provides trunk support, upper thoracic region, produces intracavitary pressure to reduce load on the intervertebral disks with rigid stays or panel(s), includes shoulder straps and closures, prefabricated, off the shelf
L0452Tlso, flexible, provides trunk support, upper thoracic region, produces intracavitary pressure to reduce load on the intervertebral disks with rigid stays or panel(s), includes shoulder straps and closures, custom fabricated
L0454Tlso flexible, provides trunk support, extends from sacrococcygeal junction to above t 9 vertebra, restricts gross trunk motion in the sagittal plane, produces intracavitary pressure to reduce load on the intervertebral disks with rigid stays or panel(s), includes shoulder straps and closures, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise
References: Dallolio V.(2005) Lumbar spinal decompression with a pneumatic orthesis (Orthotrac): preliminary study. Acta Neurochir Suppl. 2005;92: 133-137.

Janke AAW, Kerkow TA, Griffiths HG, et al.(1997) The biomechanics of gravity-dependent traction of the lumber spine. Spine 1997; 22:253-60.
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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