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Axial 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 (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 preserves 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 (TranS1) 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. Quandry Medical acquired the TranS1 technology in 2014 and re-established distribution of AxiaLIF in 2015). 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.
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 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.
05/31/2016: Policy number A.7.01.130 added. Investigative definition updated in Policy Guidelines section.
06/20/2016: Policy description updated. Policy statement unchanged.
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.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.