Facet Arthroplasty

POLICY NUMBER

A.7.01.120

DESCRIPTION

Facet arthroplasty refers to the implantation of a spinal prosthesis to restore posterior element structure and function as an adjunct to neural decompression. This procedure is proposed as an alternative to posterior spinal fusion for individuals with facet arthrosis, spinal stenosis, and spondylolisthesis.

Spinal fusion is a common surgical treatment following surgical decompression when conservative treatment fails. However, spinal fusion alters the normal biomechanics of the back, which may potentially lead to premature disc degeneration at adjacent levels. A variety of implants have been investigated as alternatives to rigid interbody or posterolateral intertransverse spinal fusion. This policy addresses the implantation of prostheses intended to replace the facet joints and excised posterior elements, termed facet arthroplasty.

The objective of facet arthroplasty is to stabilize the spine while retaining normal intervertebral motion of the surgically removed segment following neural decompression. It is proposed that facet arthroplasty should also maintain the normal biomechanics of the adjacent vertebrae. If normal motion patterns are achieved by artificial joints in the spine, the risk of adjacent-level degeneration thought to be associated with fusion may be mitigated.

In June 2023, the Total Posterior Spine (TOPS™; Premia Spine) System was approved by the U.S. Food and Drug Administration (FDA) via the premarket approval (PMA) process (PMA: P220002). Per the approval order statement, "the TOPS System is a motion-preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The TOPS system is intended to stabilize the spine following a lumbar decompression without rigid fixation. The TOPS System is indicated for patients between 35 and 80 years of age with symptomatic degenerative spondylolisthesis up to Grade 1, with moderate to severe lumbar spinal stenosis and either the thickening of the ligamentum flavum and/or of the scarring facet joint capsule at one level from L3 to L5."

TOPS System was previously granted breakthrough device status through the FDA in October 2020. The TOPS System has been marketed outside of the U.S. since 2012, and is commercially available in several European Union countries, in Australia, and in several Asian countries. FDA Product Code: QWK.

Other products are currently under review. The ACADIA® Facet Replacement System (Facet Solutions, acquired by Globus Medical in 2011) was being evaluated in a FDA regulated investigational device exemption phase 3 trial, which was completed in October 2017; results without statistical analysis were posted on ClinicalTrials.gov but have not been published in the peer-reviewed literature. ACADIA Facet Replacement System is currently only available outside of the U.S.

Related medical policies are Artificial Intervertebral Disc: Lumbar Spine and Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers) .

POLICY

Total facet arthroplasty in individuals with lumbar spinal stenosis undergoing spinal decompression is considered investigational.

POLICY EXCEPTIONS

None 

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

11/11/2010: Approved by Medical Policy Advisory Committee.

08/03/2011: Policy reviewed; no changes.

09/25/2012: Policy reviewed; no changes.

10/17/2013: Policy reviewed; no changes to policy statement. Added ICD-9 procedure codes 84.84 and 84.85 to the Code Reference section.

08/18/2014: Policy reviewed; description updated regarding devices. Policy statement unchanged.

08/31/2015: Medical policy revised to add ICD-10 codes.

10/20/2015: Policy reviewed. Investigative definition updated in the policy guidelines section.

05/31/2016: Policy number A.7.01.120 added.

01/30/2017: Policy description updated. Policy statement unchanged.

05/08/2018: Policy reviewed; no changes.

05/10/2019: Policy description updated regarding devices. Policy statement unchanged.

05/28/2020: Policy description updated regarding spinal fusion and facet arthroplasty. Policy statement unchanged.

07/14/2021: Policy reviewed; no changes.

05/27/2022: Policy reviewed; no changes.

06/27/2022: Code Reference section updated to add new CPT code 0719T, effective 07/01/2022.

05/11/2023: Policy description updated with minor changes. Policy statement unchanged.

05/16/2024: Policy description updated regarding devices. Policy statement updated to state that total facet arthroplasty in individuals with lumbar spinal stenosis undergoing spinal decompression is considered investigational.

05/08/2025: Policy description updated. Policy statement unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.120 

CODE REFERENCE

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

Investigational Codes

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