Axial Lumbosacral Interbody Fusion

POLICY NUMBER

A.7.01.130

DESCRIPTION

Axial lumbosacral interbody fusion (also called presacral, transsacral, 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.

Interbody Fusion

Interbody fusion is a surgical procedure that fuses two adjacent vertebral bodies of the spine. Lumbar interbody fusion may be performed in patients with spinal stenosis and instability, spondylolisthesis, scoliosis, following a discectomy, or for adjacent-level disc disease.

Axial Lumbosacral Interbody Fusion

An advantage of axial lumbosacral interbody fusion 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 U.S. Food and Drug Administration (FDA) has cleared for marketing multiple anterior spinal intervertebral body fixation device systems through the 510(k) pathway (See the table below). The systems are not intended to treat severe scoliosis, severe spondylolisthesis (grades 3 and 4), tumor, or trauma. The devices are also not meant for 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 the L5-S1 or L4-S1 disc spaces in conjunction with a legally marketed facet or pedicle screw systems. Food and Drug Administration product code: KWQ.

Select Anterior Spinal Intervertebral Body Fixation Orthoses Cleared by the FDA

Related medical policies are –

• Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)

• Facet Arthroplasty

POLICY

Axial lumbosacral interbody fusion is considered investigational.

POLICY EXCEPTIONS

Federal 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 GUIDELINES

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 HISTORY

03/22/2012: 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.

07/06/2017: Policy description updated regarding interbody fusion. Policy statement unchanged.

12/22/2017: Code Reference section updated to make note of deleted CPT code 0309T.

05/09/2018: Policy description updated regarding devices. Policy statement unchanged.

12/27/2018: Code Reference section updated to make note of deleted CPT codes 0195T and 0196T, effective 12/31/2018.

05/10/2019: Policy description updated regarding axial lumbosacral interbody fusion. Policy statement unchanged. Code Reference section updated to remove deleted CPT code 0309T.

06/10/2020: Policy reviewed. Policy statement unchanged. Code Reference section updated to remove deleted CPT codes 0195T and 0196T.

07/15/2021: Policy reviewed; no changes.

05/31/2022: Policy reviewed; no changes.

05/11/2023: Policy reviewed; no changes.

05/17/2024: Policy reviewed; no changes.

05/08/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.130 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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