Latest Review Date:  November 2024

POLICY:

DESCRIPTION OF PROCEDURE OR SERVICE:

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 individual. 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 dysfunctions. HCPCS codes L0450 through L0492 describe a variety of thoracic-lumbo-sacral orthoses (TLSO). 

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 Orthofix, Inc.).

The pneumatic component is inflated by the individual and is designed to lift the individual’s body weight off the spine and relieve intervertebral compression, specifically off the lumbar spine. The orthotic is designed to be worn intermittently throughout the day.

KEY POINTS:

This evidence review has been updated regularly with searches of the PubMed database. The most recent literature update was performed through November 4, 2024.

Summary of Evidence:

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 evidence is insufficient to determine the effects of the technology on health outcomes.

KEY WORDS:

Orthotrac™; pneumatic vest; ambulatory traction device, lumbo-sacral orthosis, pneumatics, Saunders Lumbar HomeTrac, Saunders Stx, ComforTrac, thoracic-lumbo-sacral orthosis with pneumatics, pneumatic orthosis

PRACTICE GUIDELINES AND POSITION STATEMENTS:

None identified.

US PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS:

Not applicable.

APPROVED BY GOVERNING BODIES:

On March 20, 1998, the FDA listed the Orthotrac™ Pneumatic Vest as a class 1 device.  This classification does not require submission of clinical data regarding efficacy but only notification of the FDA prior to marketing

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

HCPCS:        

REFERENCES:

1. Bhattacharyya M, Mcneil S, Sakka S. Non-Surgical Method of Lumbar Spinal Decompression with a Pneumatic Orthosis:Pilot Study.. Orthop Procs. 2008;90-B(SUPP_II):225-225. 
2. Dallolio V. Lumbar spinal decompression with a pneumatic orthesis (Orthotrac): preliminary study. Acta Neurochir Suppl. 2005;92:133-137.
3. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
4. Loguidice, V. et al. Clinical experience with the Orthotrac™ Pneumatic Vest providing ambulatory spinal decompression, Orthotrac™ Corporation, April 2000.
5. Orthotrac™ Corporation. Comparative case study of six orthopedic products for low back pain, using MRI to assess ambulatory spinal decompression, March 1999, pp. 1-4. Triano JJ, Rogers C, Diederich J. Discopathy with leg pain: a randomized controlled trial of Orthotrac vs EZ brace. Spine J 2003; 3(5):105-6.
6. Triano J.  A randomized, controlled trial of treatment for disc herniation with radiating leg pain.  Available online at: //www.clinicaltrials.gov/ct/show/NCT00220935. 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.
7. 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.
8. 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.

POLICY HISTORY:

Medical Review Committee, May 2001

Medical Policy Group, January 2003

Medical Policy Group, February 2004

Medical Policy Group, February 2006 (1)

Medical Policy Group, February 2007 (1)

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.