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DESCRIPTIONInterspinous fixation (fusion) devices are being developed to aid in the stabilization of the spine. They are being evaluated as alternatives to pedicle screw and rod constructs in combination with interbody fusion. Interspinous fixation devices are also being evaluated for stand-alone use in patients with spinal stenosis and/or spondylolisthesis.
Contemporary models of interspinous fixation devices have evolved from spinous process wiring with bone blocks and early device designs (e.g., Wilson plate, Meurig-Williams system, Daab plate). The newer devices range from paired plates with teeth to U-shaped devices with wings that are attached to the spinous process. They are intended to be an alternative to pedicle screw and rod constructs to aid in the stabilization of the spine with interbody fusion. Interspinous fixation devices are placed under direct visualization, while screw and rod systems may be placed either under direct visualization or percutaneously. Use of an interspinous fixation device in combination with a unilateral pedicle screw system has also been proposed. Interspinous fixation devices are not intended for stand-alone use.
Interspinous fixation (fusion) devices contrast with interspinous distraction devices (spacers), which are used alone for decompression and are typically not fixed to the spinous process. In addition, whereas interspinous distraction devices may use dynamic stabilization, interspinous fixation devices are rigid. However, the fixation devices might also be used to distract the spinous processes and decrease lordosis. Thus, the fixation devices might be used off-label without interbody fusion as decompression (distraction) devices in patients with spinal stenosis. If fixation devices are used alone as a spacer, there is a risk of spinous process fracture.
For use in combination with fusion, it is proposed that interspinous fixation systems are less invasive and present fewer risks than pedicle or facet screws. However, while biomechanical studies indicate that interspinous fixation devices may be similar to pedicle screw-rod constructs in limiting the range of flexion-extension, they may be less effective than bilateral pedicle screw-rod fixation for limiting axial rotation and lateral bending. There is a potential for a negative impact on the interbody cage and bone graft due to focal kyphosis resulting from the interspinous device. There is also a potential for spinous process fracture. Given these uncertainties, studies are needed that compare health outcomes between interspinous fixation devices and pedicle screw-rod fixation.
The following interspinous fixation devices have received clearance to market by the U.S. Food and Drug Administration (FDA). This may not be an exhaustive list.
Interspinous fixation devices are intended to be used as an adjunct to interbody fusion. For example, the indication for use of the coflex-F implant:
“is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies – with up to Grade 1 spondylolisthesis.”
Use of an interspinous fixation device for a stand-alone procedure would be considered off-label.
A related medical policy is Interspinous Distraction Devices (Spacers).
POLICYInterspinous fixation (fusion) devices are considered investigational for any indication, including but not limited to use:
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.
POLICY GUIDELINESClinical input has identified potential exceptions where the devices might be considered medically necessary, such as patients with small pedicles where pedicle screws could not be safely placed.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY03/21/2013: Approved by Medical Policy Advisory Committee.
11/15/2013: Policy reviewed; no changes.
10/16/2014: Policy reviewed; description updated regarding devices. Policy statement unchanged.
07/30/2015: Code Reference section updated for ICD-10.
11/09/2015: Policy description updated regarding devices. Policy statement unchanged. Investigative definition updated in policy guidelines section.
05/31/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.138
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.