Subject:
Facet Arthroplasty
Description:
_______________________________________________________________________________________
IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
__________________________________________________________________________________________________________________________
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 patients with facet arthrosis, spinal stenosis, and spondylolisthesis.
| Populations | Interventions | Comparators | Outcomes |
Individuals:
- With lumbar spinal stenosis
| Interventions of interest are:
- Lumbar spinal decompression with facet arthroplasty
| Comparators of interest are:
- Lumbar spinal decompression with spinal fusion
| Relevant outcomes include:
- Symptoms
- Functional outcomes
- Quality of life
- Treatment-related morbidity
|
BACKGROUND
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.
Regulatory Status
No facet arthroplasty devices have been approved by the U.S. Food and Drug Administration (FDA). 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 but has not been published. A phase 3 trial of the Total Facet Arthroplasty System® (TFAS®; Archus Orthopedics) was discontinued. (Facet Solutions acquired Archus Orthopedics in 2009. In 2011, Globus Medical acquired Facet Solutions.)
Another implant design, the Total Posterior-element System (TOPS™; Premia Spine), is currently available in Europe.
Related Policies
- Artificial Intervertebral Disc: Lumbar Spine (Policy #051 in the Surgery Section)
- Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers) (Policy #065 in the Surgery Section)
Policy:
(For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
Total facet arthroplasty is considered investigational.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
[RATIONALE: This policy was created in 2009 and has been updated regularly with searches of the PubMed database. The most recent update was performed through February 18, 2020.
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function- including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.
To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.
Clinical Context and Therapy Purpose
The purpose of facet arthroplasty in patients who have lumbar spinal stenosis is to provide a treatment option that is an alternative to or an improvement on existing therapies.
The question addressed in this policy is: Does facet arthroplasty improve the net health outcome in patients with lumbar spinal stenosis?
The following PICO was used to select literature to inform this policy.
Patients
The relevant population of interest is individuals with lumbar spinal stenosis.
Intervention
The therapy being considered is facet arthroplasty. 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. Facet replacement is a surgical procedure requiring inpatient hospitalization.
Comparators
The following therapies/tools/rules/practices are currently being used to make decisions about facet arthroplasty.
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. Facet arthropathy may also be treated with nerve ablation techniques.
Outcomes
The general outcomes of interest are pain, function, quality of life, and adverse events related to the surgical procedure. These outcomes should be measured over months to years.
A report by Palmer et al (2011) indicated the U.S. Food and Drug Administration regulated multicenter investigational device exemption trial (NCT00418197) of the Total Facet Arthroplasty System was discontinued due to financial reasons.1, Two of 10 Total Facet Arthroplasty System implants performed at the authors’ institution experienced stem fracture after total facet replacement.
A phase 3 multicenter randomized trial of the ACADIA® Facet Replacement System (NCT00401518) was completed in October 2017 but results have not yet been fully published. The trial enrolled 390 subjects with lumbar spinal stenosis, and compared facet arthroplasty with the ACADIA® system to spinal fusion. An abstract reported by Myer et al (2014) in conference proceedings provided interim 2- and 4-year results for 243 patients.2, According to a 2018 case report, 2 of 5 patients at 1 institution who received the ACADIA® Facet Replacement System as part of the trial experienced a return of neurological symptoms, local tissue reaction, and development of cobalt allergy.3,
For the TOPS™ device, Smorgick et al (2020) reported 11-year outcomes of 10 individuals from a single center in Israel who received the TOPS™ device as an adjunct to decompression to treat neurogenic claudication of at least 12 weeks' duration due to spinal stenosis with single-level grade 1 L4-5 degenerative spondylolisthesis.4, In this study, 6-week improvements in leg pain, back pain, disability and quality of life were generally maintained at 11 years. In terms of adverse events, there was 1 case of implant failure at 12 weeks that involved damaged polycarbonate urethane component that led to internal locking of the device. But, no other instances of screw loosenings or breakages, spontaneous fusion, or progression of the spondylolisthesis were observed. Although these findings are encouraging, more rigorous evaluation of the TOPS™ device in large randomized controlled trials is still needed to determine its effects on health outcomes.
Summary of Evidence
For individuals who have lumbar spinal stenosis who receive spinal decompression with facet arthroplasty, the evidence includes a preliminary report of a randomized controlled trial 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 expected to be completed October 2015, have been identified to date. In addition to the lack of evidence on clinical outcomes with facet arthroplasty, no device has received U.S. Food and Drug Administration approval. The evidence is insufficient to determine the effects of the technology on health outcomes.
SUPPLEMENTAL INFORMATION
Practice Guidelines and Position Statements
No guidelines or statements were identified.
U.S. Preventive Services Task Force Recommendations
Not applicable.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1.
Table 1. Summary of Key Trials
| NCT No. | Trial Name | Planned Enrollment | Completion Date |
| Ongoing |  | | |
| NCT03012776a | A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System | 266 | September 2023 |
| Unpublished | | | |
| NCT01933607a | Post-market Study of the TOPS™ System (TOPS) | 10 | Dec 2016 |
| NCT02234154a | Post-market Study of the TOPS™ System (TOPS) | 10 | May 2017 |
| NCT00401518a | A Pivotal Study of a Facet Replacement System (ACADIA®) to Treat Spinal Stenosis | 390 (actual) | Oct 2017(completed) |
NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial..]
________________________________________________________________________________________
Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
___________________________________________________________________________________________________________________________
Index:
Facet Arthroplasty
Total Facet Arthroplasty
Facet Arthroplasty, Total
Total Facet Arthroplasty System
TFAS
Archus Total Facet Arthroplasty System
References:
1. 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. Jul 2011;11(7):e15-19. PMID 21703940
2. Myer J, Youssef JA, Rahn KA, et al. ACADIA facet replacement system IDE clinical trial: Preliminary outcomes at two- and four-years postoperative [abstract]. Spine J. 2014;11(Suppl. 1):S160-161.
3. Goodwin, MM, Spiker, WW, Brodke, DD, Lawrence, BB. Failure of facet replacement system with metal-on-metal bearing surface and subsequent discovery of cobalt allergy: report of 2 cases.. J Neurosurg Spine, 2018 Apr 14;29(1). PMID 29652237
4. 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. 2019 Oct;1-6:1-6. PMID 31585417
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
_________________________________________________________________________________________
Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
____________________________________________________________________________________________________________________________ |