mp-182
print Print Back Back

Axial Lumbar Interbody Fusion

Policy Number: MP-182

Latest Review Date: May 2022

Category: Surgery                                                                  

 

POLICY:

 

Axial lumbosacral interbody fusion is considered investigational, including, but not limited to axial anterior lumbar fusion (AxiaLIF).

 

Laparoscopic anterior lumbar fusion (ALIF) is considered investigational.

 

DESCRIPTION OF PROCEDURE OR SERVICE:

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.

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 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 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.

 

 

 

KEY POINTS:

The most recent literature update was performed through January 17, 2022.

 

Summary of Evidence

 

For individuals who have degenerative spine disease at the L4-S1 disc spaces who receive axial lumbosacral interbody fusion, the evidence includes a comparative systematic review of case series and a retrospective comparative study. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The systematic review found that fusion rates were higher following transforaminal lumbosacral interbody fusion than following axial lumbosacral interbody fusion, although this difference decreased with use of bone morphogenetic protein or pedicle screws. The findings of this systematic review were limited by the lack of prospective comparative studies and differences in how fusion rates were determined. Studies have suggested that complication rates may be increased with 2-level axial lumbosacral interbody fusion. Controlled trials with clinical outcome measures are needed to better define the benefits and risks of this procedure compared with treatment alternatives. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

 

Practice Guidelines and Position Statements

North American Spine Society

The North American Spine Society (NASS) published guidelines on the treatment of degenerative spondylolisthesis in 2014. NASS gave a grade B recommendation for surgical decompression with fusion in patients with spinal stenosis and spondylolisthesis. The guidelines discussed posterolateral fusion, 360º fusion, and minimally invasive fusion; it did not address axial lumbosacral interbody fusion.

 

National Institute for Health and Care Excellence

In July 2018, the NICE guidance was updated and replaced by evidence-based recommendations on transaxial interbody lumbosacral fusion for low back pain in adults. The recommendation, based on a literature review conducted in December 2017, states, "Evidence on the safety of transaxial interbody lumbosacral fusion for severe chronic low back pain shows that there are serious but well-recognised complications. Evidence on efficacy is adequate in quality and quantity. Therefore, this procedure may be used provided that standard arrangements are in place for clinical governance, consent and audit. This procedure should only be done by a surgeon with specific training in the procedure, who should carry out their initial procedures with an experienced mentor."

 

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force has not addressed axial lumbosacral interbody fusion.

 

 

KEY WORDS:

Axial anterior lumbar fusion, AxiaLIF, axial lumbar interbody fusion, para-axial, pre-sacral interbody fusion, trans-sacral interbody fusion or paracoccygeal interbody fusion, axial LIF, AxiaLIF® system, AxiaLIF II Level system

 

 

APPROVED BY GOVERNING BODIES:

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 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.  

 

Select Anterior Spinal Intervertebral Body Fixation Orthoses Cleared by U.S. Food and Drug Administration

Orthotic

Manufacturer

Date Cleared

510(k) No.

TranS1® AxiaLIF™ System

  • For patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis,

spondylolisthesis (grade 1 or 2), or degenerative disc

disease limited to anterior supplemental fixation of L5-S1 in conjunction with legally marketed pedicle screws

TranS1

12/04

K040426

TranS1® AxiaLIF™ System

  • Indication modified to include facet screw

TranS1

06/05

K050965

TranS1® AxiaLIF® II System

  • For patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (grade 1 or 2), or degenerative disc disease limited to anterior supplemental fixation of L4-S1 in conjunction with legally marketed facet and pedicle screws

TranS1

04/08

K073643

TranS1® AxiaLIF® 2L System

  • Indication unchanged, marketed with branded bone morphogenetic protein

TranS1

01/10

K092124

TranS1® AxiaLIF® Plus System

  • Intended to provide anterior stabilization of the L5-SI or L4-Sl spinal segment (s) as an adjunct to spinal fusion
  • This device’s instruments are used for independently distracting the L5-S1 or L4-S1 vertebral bodies and inserting bone graft material (Dt3M, autograft or autologous blood) into the disc space.
  • Use limited to anterior supplemental fixation of the lumbar spine at L5-SI or L4-S1 in conjunction with use of legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF

TranS1

03/11

K102334

 

 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

 

 

CURRENT CODING:

CPT Codes:

22586

Arthrodesis, pre-sacral interbody technique, including disc space preparation, discectomy, with posterior instrumentation, with image guidance, includes bone graft when performed, L5-S1 interspace

22899

unlisted procedure, spine

 

 

 

REFERENCES:

 

  1. Gerszten PC, Tobler W, Raley TJ, et al. Axial presacral lumbar interbody fusion and percutaneous posterior fixation for stabilization of lumbosacral isthmic spondylolisthesis. J Spinal Disord Tech. Apr 2012; 25(2): E36-40.
  2. Gundanna MI, Miller LE, Block JE. Complications with axial presacral lumbar interbody fusion: A 5-year postmarketing surveillance experience. SAS J. 2011; 5(3): 90-4.
  3. Lindley EM, McCullough MA, Burger EL, et al. Complications of axial lumbar interbody fusion. J Neurosurg Spine. Sep 2011; 15(3): 273-9.
  4. Marchi L, Oliveira L, Coutinho E, et al. Results and complications after 2-level axial lumbar interbody fusion with a minimum 2-year follow-up. J Neurosurg Spine. Sep 2012; 17(3): 187-92.
  5. National Institute for Health and Care Excellence (NICE). Transaxial interbody lumbosacral fusion for severe chronic low back pain IPG620 2018; https://www.nice.org.uk/guidance/ipg620
  6. North American Spine Society. Diagnosis and treatment of degenerative lumbar spondylolisthesis. 2nd Ed. 2014; https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/Spondylolisthesis.pdf
  7. Shen FH, Samartzis D, Khanna AJ, et al. Minimally invasive techniques for lumbar interbody fusions. Orthop Clin North Am. Jul 2007; 38(3): 373-86; abstract vi. Schroeder GD, Kepler CK, Millhouse PW, et al. L5/S1 Fusion Rates in Degenerative Spine Surgery: A Systematic Review Comparing ALIF, TLIF, and Axial Interbody Arthrodesis. Clin Spine Surg. May 2016; 29(4): 150-5.
  8. Tobler WD, Gerszten PC, Bradley WD, et al. Minimally invasive axial presacral L5-S1 interbody fusion: two-year clinical and radiographic outcomes. Spine (Phila Pa 1976). Sep 15 2011; 36(20): E1296-301.
  9. U.S. Food and Drug Administration. Premarket Notification [510(K)] Summary. TranS1 AxiaLIF Fixation System. 2007; https://www.accessdata.fda.gov/cdrh_docs/pdf7/K073514.pdf.
  10. U.S. Food and Drug Administration. Premarket Notification [510(K)] Summary. TranS1 AxiaLIF II System. 2008; https://www.accessdata.fda.gov/cdrh_docs/pdf7/K073643.pdf.
  11. Whang PG, Sasso RC, Patel VV, et al. Comparison of axial and anterior interbody fusions of the L5-S1 segment: a retrospective cohort analysis. J Spinal Disord Tech. Dec 2013; 26(8): 437-43.
  12. Zeilstra DJ, Miller LE, Block JE. Axial lumbar interbody fusion: a 6-year single-center experience. Clin Interv Aging. 2013; 8: 1063-9.

 

POLICY HISTORY:

Medical Policy Group, April 2011 (1)

Medical Policy Administration Committee May 2011

Available for comment May 25 – July 11, 2011

Medical Policy Panel, November 2011

Medical Policy Group, March 2012 (2): Updated Description, Key Points, Key Words, References pertaining to axial lumbosacral interbody fusion

Medical Policy Group, November 2012: 2013 Coding Update – added Code 22586 & 0309T and updated verbiage on 0195T & 0196T

Medical Policy Panel, November 2013

Medical Policy Group, November 2013(4): Updated Key Points and References.  No changes to the policy statement at the time.

Medical Policy Group, April 2014 (4): Updated Approved by Governing Bodies to include name change for Baxano. No changes to the policy statement.

Medical Policy Group, February 2015 (2): Updated Key Points and References; no change to policy statement.

Medical Policy Panel, April 2017

Medical Policy Group, May 2017 (7): Updates to Key Points and References; added description to CPT 0309T. Policy Statement updated to include coverage for lateral interbody fusion.

Medical Policy Administration Committee, July 2017

Available for comment July 11 through August 24, 2017

Medical Policy Group, December 2018: Annual Coding Update 2018.  Created previous coding section and moved 0309T to this section and added existing code 22899 to current coding.

Medical Policy Panel, April 2018

Medical Policy Group, June 2018 (7): Annual review completed. No new literature to add. No change in Policy Statement.

Medical Policy Group, December 2018:  2019 Annual Coding Update. Moved CPT codes from Current coding section to Previous coding.  Updated Previous coding section to include codes 0195T and 0196T.

Medical Policy Panel, April 2019

Medical Policy Group, April 2019 (7): 2019 Updates to Key Points and References. No change to Policy Statement.

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (7): Minor updates to Key Points. No new references added. No change to Policy Statement.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (7):  Updates to References.  Policy updated to remove “not medically necessary”.  No change to policy intent. Removed policy statements effective for dates of service prior to May 31, 2017.

Medical Policy Panel, April 2022

Medical Policy Group, May 2022 (7): Updates to Title, Key Points and References. Removed Previous Coding Section. CPT 0195T, 0196T, 0309T deleted effective 12/31/18. Removed Key Words: “anterior lumbar interbody fusion, ALIF, posterior lumbar interbody fusion, PLIF, transforaminal lumbar interbody fusion, TLIF, laparoscopic ALIF, lateral interbody fusion, extreme lateral interbody fusion, XLIF, direct lateral interbody fusion, DLIF.” Clarification to Policy Statement: Removed coverage statement, “Minimally invasive interbody fusion of the lumbar spine may be considered medically necessary when using the following approaches: Anterior lumbar interbody fusion (ALIF), Posterior lumbar interbody fusion (PLIF), Transforaminal lumbar interbody fusion (TLIF) or Lateral interbody fusion (e.g., XLIF, DLIF).” These techniques are addressed per MP# 517 Lumbar Spinal Fusion. No change in policy intent.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

  1. The technology must have final approval from the appropriate government regulatory bodies;
  2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
  3. The technology must improve the net health outcome;
  4. The technology must be as beneficial as any established alternatives;
  5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

  1.  In accordance with generally accepted standards of medical practice; and
  2.  Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
  3.  Not primarily for the convenience of the patient, physician or other health care provider; and
  4.  Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.