mp-006
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Thoracic-Lumbo-Sacral Orthosis with Pneumatics

Policy Number: MP-006

Latest Review Date:  December 2020

Category:  DME                                            

Policy Grade:  Effective June 1, 2015: Active Policy but no longer scheduled for regular literature reviews and updates

POLICY:

A thoracic-lumbo-sacral orthosis incorporating pneumatic inflation is considered investigational.

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 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 dysfunctions. 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. 

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, specifically off the lumbar spine. The orthotic is designed to be worn intermittently throughout the day.

KEY POINTS:

Literature review completed December 2020. No new literature noted in 2020.

Summary of Evidence:

The absence of controlled studies of thoracic-lumbar-sacral orthosis with pneumatics precludes any conclusions regarding effectiveness for the treatment of low back pain.

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

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: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

HCPCS   

 E0830

  Ambulatory traction device, all types, each

 

REFERENCES:

  1. Dallolio V. Lumbar spinal decompression with a pneumatic orthesis (Orthotrac): Preliminary study, Acta Neurochir Suppl 2005; 92: 133-7.Accessed December 2020.

  2. Loguidice, V. et al. Clinical experience with the Orthotrac™ Pneumatic Vest providing ambulatory spinal decompression, Orthotrac™ Corporation, April 2000. 

  3. 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. 

  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. 

  5. Triano J.  A randomized, controlled trial of treatment for disc herniation with radiating leg pain.  Available online at: //www.clinicaltrials.gov/ct/show/NCT00220935.

  6. 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)

Key Points updated, added new equipment to key words as not covered, February 2008 (1)

Medical Policy Group, February 2009 (1)

Medical Policy Group, February 2010 (1) No new studies identified

Medical Policy Group, February 2011 (1) Update to Key Points and References

Medical Policy Panel, November 2012

Medical Policy Group, November 2012 (2): Added thoracic pneumatic orthoses to non-covered indications to policy. Title, Descriptions, Key Points, Key Words, and References updated to support policy statement

Medical Policy Administration, December 2012

Available for comment December 12, 2012 through January 26, 2013

Medical Policy Panel, November 2013

Medical Policy Group, January 2014 (2) Policy statement unchanged.   No new studies identified in literature search.

Medical Policy Group, June 2015 (6): Policy statement unchanged. Active policy but no longer scheduled for regular reviews and updates.

Medical Policy Group, June 2019 (6). Literature review completed. No change in policy statement, remains investigational.

Medical Policy Group, December 2020 (6): Literature review completed. No change in policy statement, remains investigational.

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.