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DESCRIPTIONAxial lumbosacral interbody fusion (also called pre-sacral, trans-sacral or paracoccygeal interbody fusion) is a minimally invasive technique designed to provide anterior access to the L4-S1 disc spaces for interbody fusion while minimizing damage to muscular, ligamentous, neural, and vascular structures. It is performed under fluoroscopic guidance.
The procedure for one level axial lumbosacral interbody fusion (axial LIF) is as follows. Under fluoroscopic monitoring, a blunt guide pin introducer is passed through a 15- to 20-mm incision lateral to the coccyx and advanced along the midline of the anterior surface of the sacrum. A guide pin is introduced and tapped into the sacrum. A series of graduated dilators are advanced over the guide pin, and a dilator sheath attached to the last dilator is left in place to serve as a working channel for the passage of instruments. A cannulated drill is passed over the guide pin into the L5-S1 disc space to rest on the inferior endplate of L5. It is followed by cutters alternating with tissue extractors, and the nucleus pulposus is debulked under fluoroscopic guidance. Next, bone graft material is injected to fill the disc space. The threaded rod is placed over the guide pin and advanced through the sacrum into L5. The implant is designed to distract the vertebral bodies and to restore disc and neural foramen height. Additional graft material is injected into the rod, where it enters into the disc space through holes in the axial rod. A rod plug is then inserted to fill the cannulation of the axial rod. Percutaneous placement of pedicle or facet screws may be used to provide supplemental fixation. An advantage of axial LIF is that it allows preservation of the annulus and all paraspinous soft tissue structures. However, there is an increased need for fluoroscopy, and an inability to address intracanal pathology or visualize the discectomy procedure directly. Complications of the axial approach may include perforation of the bowel and injury to blood vessels and/or nerves.
The AxiaLIF® and AxiaLIF II Level systems were developed by TranS1 and consist of techniques and surgical instruments for creating a pre-sacral access route to perform percutaneous fusion of the L5-S1 or L4–S1 vertebral bodies. (In 2013, TranS1 acquired Baxano and changed the company name to Baxano Surgical.) The U. S. Food and Drug Administration (FDA) marketing clearance (510[k]) summaries indicates that the procedures are intended to provide anterior stabilization of the spinal segments as an adjunct to spinal fusion and to assist in the treatment of degeneration of the lumbar disc; to perform lumbar discectomy; or to assist in the performance of interbody fusion. The AxiaLIF® systems are indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. They are not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor, or trauma. The devices are not meant to be used in patients with vertebral compression fractures or any other condition in which the mechanical integrity of the vertebral body is compromised. Their usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 or L4-S1 in conjunction with legally marketed facet or pedicle screw systems.
Related medical policies are –
POLICYAxial lumbosacral interbody fusion (axial LIF) 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.
POLICY GUIDELINESInvestigative 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 HISTORY03/22/2012: Approved by Medical Policy Advisory Committee.
01/07/2013: Added the following new 2013 CPT codes to the Code Reference section: 22586 and 0309T. Revised the descriptions of CPT codes 0195T and 0196T.
03/13/2013: Policy reviewed; no changes.
03/10/2014: Policy reviewed; description updated. Policy statement unchanged.
12/22/2014: Policy reviewed; description updated. Policy statement unchanged.
07/08/2015: Code Reference section updated for ICD-10.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.130
This may not be a comprehensive list of procedure codes applicable to this policy.