Pending Policies - Surgery


Facet Arthroplasty

Number:SUR712.034

Effective Date:11-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Facet arthroplasty, by any method, including but not limited to the Total Facet Arthroplasty System®, whether performed inpatient or outpatient, or as part of another procedure, is considered experimental, investigational and/or unproven.

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 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 medical 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) is currently being evaluated as part of an ongoing Food and Drug Administration-regulated investigational device exemption phase 3 trial. 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.

Rationale:

This medical policy was created in July 2011 and has been updated regularly with searches of the MEDLINE database. The most recent update was performed through February 5, 2018.

Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are 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 a technology, 2 domains are examined: the relevance and the 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.

Facet Arthroplasty

A report by Palmer et al. (2011) indicated that 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.

An abstract reported by Myer et al. (2014) in conference proceedings provided interim 2- and 4-year results for 243 patients from a phase 3 multicenter randomized trial of the ACADIA Facet Replacement System (NCT00401518; see Table 1). (2) The study, which was completed in late 2017, enrolled 390 subjects with lumbar spinal stenosis, and compared facet arthroplasty with the ACADIA system to spinal fusion. Submission of trial data to the U.S. Food and Drug Administration is expected.

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. 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.

Practice Guidelines and Position Statements

No guidelines or statements were identified.

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

NCT01933607a

Post-market Study of the TOPS™ System (TOPS)

10

Dec 2016 (ongoing)

NCT02234154a

Post-market Study of the TOPS™ System (TOPS)

10

May 2017

(ongoing)

Unpublished

NCT00401518a

A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis (2)

390

Oct 2017 (completed)

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0202T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

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. Facet Arthroplasty. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2018 April) Surgery 7.01.120.

Policy History:

DateReason
11/15/2018 Document updated with literature review. Coverage unchanged. Reference 2 added, one reference removed.
6/1/2017 Reviewed. No changes.
9/15/5016 Document updated with literature review. Coverage unchanged.
10/1/2015 Reviewed. No changes.
4/1/2014 Document updated with literature review. Coverage unchanged.
7/1/2011 New medical document. Facet arthroplasty, by any method, including but not limited to the Total Facet Arthroplasty System, whether performed inpatient or outpatient, or as part of another procedure, is considered experimental, investigational and unproven.

Archived Document(s):

Title:Effective Date:End Date:
Facet Arthroplasty06-01-201711-14-2018
Facet Arthroplasty09-15-201605-31-2017
Facet Arthroplasty10-01-201509-14-2016
Facet Arthroplasty04-01-201409-30-2015
Facet Arthroplasty07-01-201103-31-2014
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