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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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
07/23/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number L.1.03.401 added. Investigative definition updated in Policy Guidelines section.
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.
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