mp-367 - Medical Policies - Alabama
Policy Number: MP-367
Latest Review Date: April 2022
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 patients 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.
This policy has been updated regularly with searches of the MEDLINE database. The most recent update was performed through January 17, 2022.
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 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 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 that the technology results in an improvement in the net health outcome.
Practice Guidelines and Position Statements
No guidelines were identified.
U.S. Preventative Services Task Force Recommendations
Total facet arthroplasty, facet arthroplasty, TFAS, ACADIA® Facet Replacement System.
APPROVED BY GOVERNING BODIES:
No facet arthroplasty devices have been approved by the U.S. Food and Drug Administration (FDA) at this time. 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 III trial of the Total Facet Arthroplasty System® (TFAS®, Archus Orthopedics) has been 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.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Posterior vertebral joint(s) arthroplasty (e.g. facet joint[s] replacement) including facetectomy, laminectomy, foraminectomy and vertebral with or without injection of bone cement, including fluoroscopy, single level, lumbar spine
- Goodwin, MM, Spiker, WW, Brodke, DD, Lawrence, BB. Failure of facet replacement system with metalon-metal bearing surface and subsequent discovery of cobalt allergy: report of 2 cases. J Neurosurg Spine, 2018 Apr 14;29(1).
- 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.
- 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 2011; 11(7):e15-9.
- 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.
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.
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.