Medical Policy

 

Subject: Facet Joint Allograft Implants for Facet Disease
Document #: SURG.00114 Publish Date:    12/27/2017
Status: Reviewed Last Review Date:    11/02/2017

Description/Scope

This document addresses surgically implanted allografts as a stand-alone procedure to treat facet joint pain. Facet joint pain can be caused by trauma or degenerative changes resulting in structural misalignment and instability of the vertebral column.

Note: Please see the following related document(s) for additional information:

Position Statement

Investigational and Not Medically Necessary:

Allograft facet implants are considered investigational and not medically necessary for all indications.

Rationale

Facet joint pain is treated initially with conservative measures such as medication, immobilization of the affected spinal area and physical therapy. When conservative therapy fails, intermittent anesthetic injections or neurolytic techniques can be used to alleviate pain. Surgical fusion is reserved for those individuals for whom less invasive treatments have failed.

Use of facet allografts as a stand-alone procedure for facet pain has been proposed for symptomatic pain relief and possibly long-term fusion. This technique involves a minimally invasive procedure with fluoroscopic guidance. The affected facet surfaces are prepped for placement of an allograft dowel with instrumentation for expansion and stabilization of the facet joint space.

The allograft is made from bone obtained from both the femur and tibia. The allograft is processed by licensed tissue banks which are required to be fully compliant with all U.S. Food and Drug Administration (FDA) requirements for tissue processing in the United States. Therefore, the allografts are not subject to FDA 510k clearance and can be marketed.

Although the allografts have been implanted in many individuals, no clinical trials were conducted. Without well-designed clinical trials, it is not possible to assess this technology for clinical efficacy and safety.

At this time, no major authoritative body has published a document supporting the use of facet allografting, including the current version of the American Pain Society’s Clinical Guideline for the Evaluation and Management of Low Back Pain (Chou, 2009).

An updated literature search based on the MEDLINE database through September 2017 did not identify any new literature to support the use of facet allografts as a stand-alone procedure for facet pain.

Background/Overview

Spinal fusion remains the gold standard for treatment of refractory back pain. However, this procedure is difficult and requires extended recovery time. Newer techniques are being developed using surgical approaches and instrumentation that will result in pain relief and less recovery time. Areas of concern are instrumentation, implant performance and possible migration.

Definitions

510k Clearance: The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976). The 510(k) submitter compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable. Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. The FDA does not “approve” 510(k) submissions. It “clears” them.

Allograft: A graft of tissue obtained from a donor of the same species as, but with a different genetic make-up from, the recipient, as a tissue transplant between two humans.

Facet joints: Joints of the spine that connect the vertebrae and allow coordinated movement of the vertebral column.

Fluoroscopic guidance: Use of radiologic imaging to assist in the placement of instrumentation for invasive diagnostic and surgical procedures.

Neurolytic: Substance or procedure that destroys nerves.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:

CPT

 

0219T

Placement of a posterior intrafacet implant(s), unilateral or bilateral, including imaging and placement of bone graft(s) or synthetic device(s), single level; cervical

0220T

Placement of a posterior intrafacet implant(s), unilateral or bilateral, including imaging and placement of bone graft(s) or synthetic device(s), single level; thoracic

0221T

Placement of a posterior intrafacet implant(s), unilateral or bilateral, including imaging and placement of bone graft(s) or synthetic device(s), single level; lumbar

0222T

Placement of a posterior intrafacet implant(s), unilateral or bilateral, including imaging and placement of bone graft(s) or synthetic device(s), single level; each additional vertebral segment

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Chou R, Baisden J, Carragee EJ, et al. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine (Phila Pa 1976). 2009; 34(10):1094-1109.
  2. Harris EB, Massey P, Lawrence J, et al. Percutaneous techniques for minimally invasive posterior lumbar fusion. Neurosurg Focus. 2008; 25(2):E12.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Chou R., Huffman LH. American Pain Society. APS Clinical Guideline for the Evaluation and Management of Low Back Pain. 2009. Available at: http://americanpainsociety.org/uploads/education/guidelines/evaluation-management-lowback-pain.pdf. Accessed on September 5, 2017.
  2. U.S. Food and Drug Administration (FDA). Overview of Device Regulation. Available at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/default.htm. Accessed on September 5, 2017.
Index

NuFix™
TruFUSE® Allograft

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. 

Document History

Status

Date

Action

Reviewed

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” References updated.

Reviewed

11/03/2016

MPTAC review. Updated Description, Rationale and References sections.

Reviewed

11/05/2015

MPTAC review. Updated Rationale and Reference sections. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review. Updated Description and References.

Reviewed

11/14/2013

MPTAC review. Updated Rationale, References and Websites.

Reviewed

11/08/2012

MPTAC review. References updated

Reviewed

11/17/2011

MPTAC review. References updated.

Reviewed

11/18/2010

MPTAC review. Rationale and References updated.

New

11/19/2009

MPTAC review. Initial document development.