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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 04/01/2013 Title: Pre-Sacral Arthrodesis
Revision Date: 01/01/2019 Document: BI397:00
CPT Code(s): 0195T, 0196T, 22586,22899
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

 

1.    Pre-sacral arthrodesis (AxiaLIF) is the use of a minimally invasive system for fusion of lower vertebrae.

2.    AxiaLIF is considered Experimental/ Investigational and is not a covered benefit.


Medical Statement

Axial lumbar interbody fusion (AxiaLIF), a percutaneous pre-sacral access route to the L4 – S1 vertebral bodies for spinal fusion, is considered experimental and investigational because of insufficient evidence of its effectiveness.

Codes Used In This BI:

0195T

 

0196T

 Arthrodesis, pre-sacral interbody tech, disc spc prep, discectomy, w/out

 instrmnt, w/img guid, incl bone graft when perf; L5 – S1 intrspc (code deleted 1/1/19)

 Arthrodesis, pre-sacral interbody tech, disc spc prep, discectomy, w/out  

 instrmnt, w/img guid, incl bone graft when perf; L4 – L5 intrspc (code deleted 1/1/19)

22586   Arthrodesis, pre-sacral interbody technique, incl disc spc prep, discectomy, 

             w/posterior instrmnt, w/img guid, incl bone graft when perf, L5 – S1 intrspc

22899   Unlisted procedure of spine (i.e. Arthrodesis, pre-sacral interbody tech, disc spc

             prep, discectomy, w/out instrmnt, w/img guid, incl bone graft when perf; L4 – L5

             and/or L5 – S1 intrspc)


Background

Interbody fusion (arthrodesis) in the lumbar spine is performed to treat painful symptoms caused by instability of the vertebrae, such as spondylolisthesis, spinal stenosis, or degenerative disc disease. Methods of spinal fusion include bone grafts or metal implants placed either anteriorly, posteriorly, or laterally; however, insertion of these implants is not without surgical risk. Numerous open and minimally invasive techniques have been developed but all of these approaches experience the same shortcomings related to biomechanics or inherent iatrogenic destabilization.

In an attempt to alleviate many of the limitations of previous techniques, a pre-sacral approach to the lumbosacral junction has been investigated. Transaxial anterior lumbar interbody fusion is an emerging minimally invasive spinal fusion procedure used to treat patients with chronic lower back pain (Ollendorf, et al., 2011). This procedure is an alternative to traditional fusion techniques that utilize anterior or posterior approaches to directly expose the lumbosacral spine. In the case of transaxial anterior lumbar interbody fusion the spine is accessed percutaneously via the anterior surface of the sacrum.

Percutaneous AxiaLIF (also called anterior para-axial, trans-sacral or paracoccygeal interbody fusion, performed with the AxiaLIF® and AxiaLIF 2 Level systems) is a minimally invasive technique that uses axial access to the L5-S1 disc spaces. Under fluoroscopic monitoring, a guide pin is passed through a small (15- to 20-mm) incision lateral to the coccyx and advanced along the midline of the anterior surface of the sacrum. A series of graduated dilators is passed along the guide pin, which serves as a working channel for the passage of instruments. Under fluoroscopic guidance, the nucleus pulposus is debulked and bone graft material is injected through a threaded rod to fill the disc space. Percutaneous pedicle or facet screws are also used. Although the procedure may minimize damage to adjacent tissue, it is performed entirely under indirect visualization with fluoroscopy and is not able to address posterior element pathology.


Reference
  1. DeVine JG, Gloystein D, Singh N. A novel alternative for removal of the AxiaLif (TranS1) in the setting of pseudarthrosis of L5-S1. Spine J. 2009;9(11):910-915.
  2. Bohinski RJ, Jain VV, Tobler WD. Presacral retroperitoneal approach to axial lumbar interbody fusion: A new, minimally invasive technique at L5-S1: Clinical outcomes, complications, and fusion rates in 50 patients at 1-year follow-up. SAS J. 2010;4(54-62.
  3. Leopardi D. Transaxial lumbar interbody fusion. Horizon Scanning Technology Prioritising Study. Canberra, ACT: Australia and New Zealand Horizon Scanning Network; April 2010.
  4. National Institute for Health and Clinical Excellence (NICE). Transaxial interbody lumbosacral fusion. Interventional Procedure Guidance 387. London, UK: NICE; March 2011.
  5. Andersson GB , Mekhail NA , Block JE . Treatment of intractable discogenic low back pain. A systematic review of spinal fusion and intradiscal electrothermal therapy (IDET). Pain Physician. 2006;9(3):237-248.
  6. Ollendorf DA, Silverstein MD, Andry A, Pearson SD. Management options for patients with low back disorders. Final Appraisal Document. Boston, MA; Institute for Clincial and Economic Review (ICER); June 24, 2011.
  7. Tobler WD, Ferrara LA. The presacral retroperitoneal approach for axial lumbar interbody fusion: A prospective study of clinical outcomes, complications and fusion rates at a follow-up of two years in 26 patients. J Bone Joint Surg Br. 2011;93(7):955-960.
  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). 2011;36(20):E1296-E1301.
  9. Gundanna MI, Miller LE, Block JE. Complications with axial presacral lumbar interbody fusion: A 5-year postmarketing surveillance experience. SAS Journal. 2011;5(3):90-94.
  10. Lindley EM, McCullough MA, Burger EL, Brown CW, Patel VV. Complications of axial lumbar interbody fusion. J Neurosurg Spine. 2011;15(3):273-279.
  11. Gerszten PC, Tobler WD, Nasca RJ. Retrospective analysis of L5-S1 axial lumbar interbody fusion (AxiaLIF): A comparison with and without the use of recombinant human bone morphogenetic protein-2. Spine J. 2011;11(11):1027-1032.
  12. 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. 2012;25(2):E36-E40.
  13. Marchi L, Oliveira L, Coutinho E, Pimenta L. Results and complications after 2-level axial lumbar interbody fusion with a minimum 2-year follow-up. J Neurosurg Spine. 2012;17(3):187-192.
  14. Patil SS, Lindley EM, Patel VV, Burger EL. Clinical and radiological outcomes of axial lumbar interbody fusion. Orthopedics. 2010;33(12):883.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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