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DESCRIPTIONA 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 L0300 through L0620 describe a variety of thoracic-lumbo-sacral orthoses (TLSO). Recently, an orthotic that includes a pneumatic component has become commercially available, the Orthotrac Pneumatic Vest™ (manufactured by Kinesis Medical, Minneapolis, Minn.). 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. 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.
POLICYA thoracic-lumbo-sacral orthosis incorporating pneumatic inflation is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/2001: Approved by Medical Policy Advisory Committee (MPAC)
2/14/2002: Investigational definition added
2/25/2002: Sources and Place of Service sections updated
5/2/2002: Type of Service and Place of Service deleted
5/29/2002: Code Reference section completed
8/26/2005: Code Reference section updated, HCPCS K0112, K0113 deleted, HCPCS L1499 added
1/22/2007: Policy reviewed, description rewritten for clarity
12/17/2008: Policy reviewed, no changes in policy statement.
04/14/2010: Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
05/17/2011: Policy description and statement unchanged. The Sources section was updated to add the new Blue Cross Blue Shield Association policy number and to remove outdated references.
01/17/2012: Policy reviewed; no changes.
03/13/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy # 1.03.03
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.