Latest Review Date: April 2024

Category: Surgery                                                                

POLICY:

Total facet arthroplasty is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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.

KEY POINTS:

This policy has been updated regularly with searches of the PubMed database. The most recent literature update was performed through March 5, 2024.

Summary of Evidence

For individuals who have lumbar spinal stenosis who receive spinal decompression with facet arthroplasty, the evidence includes a preliminary report of an otherwise unpublished randomized controlled trial (RCT), 2 planned interim analyses of an ongoing RCT, and a few case series studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Interim results from a pivotal trial of the ACADIA Facet Replacement System were reported in 2012. No additional publications from this trial, which was completed in October 2017, have been identified to date. Interim results from a pivotal randomized trial of the Total Posterior Spine System (TOPS) indicated substantial improvement compared to baseline at 1 year and over transforaminal lumbar interbody fusion (TLIF) in multiple patient-reported outcomes related to functional status and symptoms up to 2 years post-operatively; the results further suggested relatively preserved range of motion at the treated vertebral level with TOPS versus TLIF, without increased risk of adverse events. Based on 24-month results, the TOPS System received U.S. Food and Drug Administration approval in June 2023; the final trial results have not yet been published. While the interim results are promising, clarity is needed on the final results of the trial to determine if adjustments for increased risk of type 1error were made and to evaluate other strengths and limitations of the trial. Additionally, continued follow-up of the TOPS trial is ongoing, which will shed light on longer-term safety profiles of TOPS versus TILF with lumbar spinal decompression. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

No guidelines or statements were identified as of March 2024.

U.S. Preventative Services Task Force Recommendations

Not applicable.

KEY WORDS:

Total facet arthroplasty, facet arthroplasty, TFAS, ACADIA® Facet Replacement System, Total Posterior Spine System (TOPS)

APPROVED BY GOVERNING BODIES:

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 amotion-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 80years 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 an 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.

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.

CURRENT CODING: 

CPT Codes:

REFERENCES:

1. ClinicalTrials.gov. A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis (NCT00401518). Updated September 10, 2020.
2. Coric D, Nassr A, Kim PK, et al. Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis. J Neurosurg Spine. Jan 01 2023; 38(1): 115-125.
3. Goodwin ML, Spiker WR, Brodke DS, et al. Failure of facet replacement system with metal-on-metal bearing surface and subsequent discovery of cobalt allergy: report of 2 cases. J Neurosurg Spine. Jul 2018; 29(1): 81-84.
4. Gu BJ, Blue R, Yoon J, et al. Posterior Lumbar Facet Replacement and Arthroplasty. Neurosurg Clin N Am. Oct 2021; 32(4): 521-526. 
5. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
6. Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. Jan 04 2016; 352: h6234. 
7. Myer J, Youssef JA, Rahn KA, et al. ACADIA facet replacement system IDE clinical trial: Preliminary outcomes at two-and four-years postoperative. Spine J. 2014; 11(SUPPL. 1):S160-161.
8. Palmer DK, Inceoglu S, Cheng WK. Stem fracture after total facet replacement in the lumbar spine: a report of two cases and review of the literature. Spine J. July 2011; 11(7):e15-9.
9. Pinter ZW, Freedman BA, Nassr A, et al. A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of DegenerativeSpondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study. Clin Spine Surg. Mar 01 2023; 36(2):E59-E69.
10. Smorgick Y, Mirovsky Y, Floman Y et al. Long-term results for total lumbar facet joint replacement in the management of lumbar degenerative spondylolisthesis. J Neurosurg Spine. Oct 04 2019: 1-6.
11. U.S. Food and Drug Administration. Premarket Approval (PMA): TOPS System. June 15, 2023. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220002.
12. U.S. Food and Drug Administration. Summary of safety and effectiveness data (SSED): TOPS System. June 15, 2023. www.accessdata.fda.gov/cdrh_docs/pdf22/P220002B.pdf.

POLICY HISTORY:

Medical Policy Group, July 2009 (1)

Medical Policy Administration Committee, August 2009

Available for comment August 10-September 23, 2009

Medical Policy Group, July 2010 (1) Updated Key Points and Governing Bodies information

Medical Policy Group, July 2011 (1) Updated Key Points, Approved by Governing Bodies, References

Medical Policy Group, July 2012 (1) Update to Key Points, Approved by Governing Bodies, and References related to MPP update; no change in policy statement.

Medical Policy Panel, July 2013

Medical Policy Group, September 2013 (2) Policy updated with literature review through June 2013.  Policy statement unchanged.  Minor wording changed to Key Points.

Medical Policy Panel July, 2014

Medical Policy Group July, 2014 (4): Updated Key Points, added USPSTF section.  There are no changes to the policy statement at this time.

Medical Policy Panel, July 2015

Medical Policy Group, July 2015 (2): 2015 Updates to Key Points and Key Words, no change to policy statement.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (7): 2017 Updates to Key Points & References; no change to policy statement.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (7): 2018 Updates to Key Points; no change to policy statement.

Medical Policy Panel, April 2019

Medical Policy Group, April 2019 (7): 2019 Updates to Key Points & References. No change to policy statement.

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (7): Updates to Key Points and References.  No change to policy statement.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (7): Updates to Key Points and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, April 2022

Medical Policy Group, April 2022 (7): Minor updates to Key Points. No literature added. No change to policy statement.

Medical Policy Panel, April 2023

Medical Policy Group, April 2023 (7): Updates to Key Points, Approved By Governing Bodies, Benefit Application, Current Coding- code description for code 0202T was updated, and References. No change to policy statement.

Medical Policy Panel, April 2024

Medical Policy Group, April 2024 (7): Updates to Key Points, Approved By Governing Bodies, and References. Added Key Words: “Total Posterior Spine System (TOPS).” No change to Policy Statement.

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.