Pending Policies - Surgery


Interspinous Fixation (Fusion) Devices

Number:SUR712.040

Effective Date:11-15-2018

Coverage:

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

Interspinous fixation (fusion) devices, are considered experimental, investigational and/or unproven for any indication, including but not limited to use:

In combination with interbody fusion, or

Alone for decompression in patients with spinal stenosis.

EXCEPTION: Clinical input has identified potential exceptions where the devices might be considered medically necessary, such as patients with small pedicles where pedicle screws could not be safely placed.

NOTE 1: The coflex Interlaminar Stabilization Device, referred to in SUR712.029 (Interspinous Distraction (Spacers) and Interlaminar Stabilization Device), is different from the coflex-IF® device addressed in this policy.

NOTE 2: The name of the specific fixation device used for the procedure should be included in the clinical documentation.

Description:

Interspinous fixation (fusion) devices are being developed to aid in the stabilization of the spine. They are evaluated as alternatives to pedicle screw and rod constructs in combination with interbody fusion. Interspinous fixation devices (IFDs) are also being evaluated for stand-alone use in patients with spinal stenosis and/or spondylolisthesis.

Contemporary models of IFDs have evolved from spinous process wiring with bone blocks and early device designs (e.g., Wilson plate, Meurig-Williams system, Daab plate). The newer devices range from paired plates with teeth to U-shaped devices with wings that are attached to the spinous process. They are intended as an alternative to pedicle screw and rod constructs to aid in the stabilization of the spine with interbody fusion. IFDs are placed under direct visualization, while screw and rod systems may be placed under direct visualization or percutaneously. Use of an IFD in combination with a unilateral pedicle screw system has also been proposed. IFDs are not intended for stand-alone use.

For use in combination with fusion, it has been proposed that IFDs are less invasive and present fewer risks than pedicle or facet screws. While biomechanics studies have indicated that IFDs may be similar to pedicle screw-rod constructs in limiting the range of flexion and extension, they may be less effective than bilateral pedicle screw-rod fixation for limiting axial rotation and lateral bending. (1) There is a potential for a negative impact on the interbody cage and bone graft due to focal kyphosis resulting from the IFD. There is also a potential for spinous process fracture.

Unlike IFDs, interspinous distraction devices (spacers) are used alone for decompression and are typically not fixed to the spinous process. In addition, interspinous distraction devices have been designed for dynamic stabilization, whereas IFDs are rigid. However, IFDs might also be used to distract the spinous processes and decrease lordosis. Thus, IFDs could be used off-label without interbody fusion as decompression (distraction) devices in patients with spinal stenosis. If IFDs are used alone as a spacer, there is a risk of spinous process fracture.

Regulatory Status

The following IFDs have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process. This list may not be exhaustive.

Affix™ (NuVasive)

Aileron™ (Life Spine)

Aspen™ (Lanx, acquired by BioMet)

Axle™ (X-Spine)

BacFuse® (Pioneer Surgical)

BridgePoint™ (Alphatec Spine)

coflex-IF® (Paradigm Spine)

Inspan™ (Spine Frontier)

InterBRIDGE® Interspinous Posterior Fixation System (LDR Spine)

Minuteman™ (Spinal Simplicity)

PrimaLOK™ (OsteoMed Spine)

Octave™ (Life Spine)

Spire™ (Medtronic)

SP-Fix™ (Globus)

ZIP® MIS Interspinous Fusion System (Aurora Spine).

Food and Drug Administration product code: PEK.

IFDs are intended for use as an adjunct to interbody fusion. For example, the indication for the coflex-IF® implant is as: “a posterior, nonpedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies – with up to Grade 1 spondylolisthesis.”

A number of interspinous plate systems have also been cleared for marketing by the Food and Drug Administration.

Use of an IFD for a stand-alone procedure is considered off-label.

Rationale:

This policy was originally created in February 2016 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed though 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 uses 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.

Interspinous Fixation Device with Fusion

A systematic review by Lopez et al. (2017) evaluated the literature on lumbar spinous process fixation and fusion devices. (2) Reviewers included both interspinous plates and fixation devices, and excluded dynamic devices such as the X-Stop. Fifteen articles met inclusion and exclusion criteria, including 4 comparative studies (level III evidence), 2 case series (level IV evidence), and 9 in vitro biomechanics studies (level V evidence). Two of the nonrandomized studies compared interspinous fixation devices (IFDs) with pedicle screws in patients undergoing interbody fusion and 2 included IFD alone or pedicle screws plus an IFD in patients undergoing interbody fusion. Use of an IFD decreased surgical time and blood loss compared with pedicle screws. No study showed that IFDs reduced the hospital length of stay compared with pedicle screw implantation.

Included in the systematic review was a nonrandomized retrospective study by Kim et al. (2012) that compared the SPIRE IFD with pedicle screw implantation in patients who underwent posterior lumbar interbody fusion. (3) In this study, 40 patients underwent IFD with posterior lumbar interbody fusion and 36 underwent pedicle screw fixation with posterior lumbar interbody fusion during the same time period. The 2 groups were comparable at baseline, but the treatment selection criteria were not described. At a minimum 1-year follow-up, scores on the visual analog scale (VAS) for pain and on the Korean version of the Oswestry Disability Index improved to a similar extent in both 2 groups. For example, VAS scores in the IFD group improved from 7.16 to 1.3 while VAS scores in the pedicle screw group improved from 8.03 to 1.2. Range of motion at the adjacent segment was increased in the pedicle screw group but not in the IFD group, and adjacent segment degeneration was more prevalent in the pedicle screw group (36.1%) than in the IFD group (12.5%; p=0.029), Other adverse events, such as deep infection and cerebrospinal fluid leakage, were higher in the pedicle screw group.

A study by Vokshoor et al. (2014), also included in the systematic review, reported on a retrospective series of 86 patients who had a spinous process device implanted. (4) Some patients received IFD with interbody fusion and some received an IFD plus pedicle screws and interbody fusion. After adjusting for age and sex, there was a 3.6-point decrease in VAS scores for pain that was maintained over the 12-month follow-up. In the 50 patients who had computed tomography scans, interspinous process fusion was observed in 94%. Presence of an interbody cage did not affect the fusion rate. Two (2.3%) patients had devices removed due to pain secondary to spinous process and/or lamina fracture.

Section Summary: Interspinous Fixation Device With Fusion

The evidence for use of IFD with interbody fusion for those undergoing spinal fusion consists of a systematic review of nonrandomized comparative studies and case series. There is a lack of evidence on the efficacy of IFDs in combination with interbody fusion. One risk is spinous process fracture, while a potential benefit is a reduction in adjacent segment degeneration. Randomized trials with longer follow-up are needed to evaluate the risks and benefits following use of IFDs compared with the established standard (pedicle screw with rod fixation).

IFD as a Stand-Alone

Sclafani et al. (2014) reported on an industry-sponsored, retrospective series of the polyaxial PrimaLOK interspinous fusion device. (5) Thirty-four patients were implanted with the IFD alone, 16 patients received the PrimaLOK plus an interbody cage, and 3 patients received the PrimaLOK plus pedicle screw instrumentation and an interbody cage. Evaluation at 6 weeks found no cases of fracture or device migration, although there were 4 cases of hardware removal and 2 cases of reoperation for adjacent-level disease during follow-up. At a mean 22 months after the index surgery, the average pain score had improved from 7.2 to 4.5 on a 10-point scale (method of collection, e.g., VAS, were not specified). There was a statistically significant improvement in pain score for patients with degenerative disc disease with lumbar stenosis (2.8, n=25, p<0.001) and spondylolisthesis (4.6, n=6, p=0.01), but not for patients with lumbar disc herniation (2.2, n=10, p>0.05).

Section Summary: IFD as a Stand-Alone

There is a lack of evidence (only a retrospective series) on the efficacy of IFDs as a stand-alone procedure for those who have spinal stenosis and/or spondylolisthesis. Randomized controlled trials are needed that evaluate health outcomes following use of IFDs as a stand-alone for decompression.

Summary of Evidence

For individuals who are undergoing spinal fusion who receive an interspinous fixation device (IFD) with interbody fusion, the evidence includes a systematic review of nonrandomized comparative studies and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, resource utilization, and treatment-related morbidity. There is a lack of evidence on the efficacy of IFDs in combination with interbody fusion. One risk is spinous process fracture, while a potential benefit is a reduction in adjacent segment degeneration. Randomized trials with longer follow-up are needed to evaluate the risks and benefits following use of IFDs compared with the established standard (pedicle screw with rod fixation). The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have spinal stenosis and/or spondylolisthesis who receive an IFD alone, the evidence includes a retrospective series. Relevant outcomes are symptoms, functional outcomes, quality of life, resource utilization, and treatment-related morbidity. There is a lack of evidence on the efficacy of IFDs as a stand-alone procedure. Randomized controlled trials are needed that evaluate health outcomes following use of IFDs as a stand-alone for decompression. The evidence is insufficient to determine the effects of the technology on health outcomes.

Clinical Input Received From Physician Specialty Societies and Academic Medical Centers

In response to Blue Cross Blue Shield Association (BCBSA) requests, input was received from 3 physician specialty societies (2 reviewers) and 2 academic medical centers while this policy was under review in 2012. The input was mixed. Some indications where the devices might be medically necessary were noted, such as patients with small pedicles where pedicle screws could not be safely placed.

Practice Guidelines and Position Statements

The North American Spine Society issued a coverage position in 2004 on the use of interspinous devices with lumbar fusion. (6) The society noted that interspinous fixation with fusion for stabilization was currently not indicated as an alternative to pedicle screw fixation with lumbar fusion procedures.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this medical policy are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT01455805a

Efficacy and Quality of Life Following Treatment of Lumbar Spinal Stenosis, Spondylolisthesis or Degenerative Disc Disease With the Minuteman Interspinous Interlaminar Fusion Implant Versus Surgical Decompression

50

Dec 2020

Unpublished

NCT01560273a

A Multi-Center Prospective Study Evaluation Aspen Spinous Process Fixation System for Use in Posterolateral Fusion (PLF) in Patients With Spondylolisthesis

25

Sep 2015

(terminated)

NCT01016314a

A Multi-Center Prospective Randomized Study to Evaluate the Efficacy of the Aspen Spinous Process System for Use in Anterior Lumbar Interbody Fusion (ALIF)

39

Jan 2016 (completed)

NCT01549366a

A Multi-Center Prospective Randomized Study Comparing Supplemental Posterior Instrumentation, Aspen™ Spinous Process System Versus Pedicle Screw Fixation, in Lateral Lumbar interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)

64

Jan 2016 (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:

There are no specific CPT codes for insertion of these devices. The following add-on codes might be used: 22840, 22853, 22854 and 22859.

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

22840, 22853, 22854, 22859, 22899

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. Wu JC, Mummaneni PV. Using lumbar interspinous anchor with transforaminal lumbar interbody fixation. World Neurosurg. May 2010; 73(5):471-472. PMID 20920928

2. Lopez AJ, Scheer JK, Dahdaleh NS, et al. Lumbar spinous process fixation and fusion: a systematic review and critical analysis of an emerging spinal technology. Clin Spine Surg. Nov 2017; 30(9):E1279-E1288. PMID 27438402

3. Kim HJ, Bak KH, Chun HJ, et al. Posterior interspinous fusion device for one-level fusion in degenerative lumbar spine disease: comparison with pedicle screw fixation - preliminary report of at least one year follow up. J Korean Neurosurg Soc. Oct 2012; 52(4):359-364. PMID 23133725

4. Vokshoor A, Khurana S, Wilson D, et al. Clinical and radiographic outcomes after spinous process fixation and posterior fusion in an elderly cohort. Surg Technol Int. Nov 2014; 25:271-276. PMID 25433267

5. Sclafani JA, Liang K, Ohnmeiss DD, et al. Clinical outcomes of a polyaxial interspinous fusion system. Int J Spine Surg. Feb 2014; 8. PMID 25694912

6. North American Spine Society (NASS). NASS coverage policy recommendations: Interspinous fixation with fusion. 2004; Available at <https://www.spine.org> (accessed March 6, 2017).

7. Interspinous Fixation (Fusion) Devices. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2018 April) Surgery 7.01.138.

Policy History:

DateReason
11/15/2018 Document updated with literature review. Coverage unchanged
9/1/2017 Document updated with literature review. Coverage unchanged.
2/1/2017 Coverage section changed to include the following: NOTE: Clinical input has identified potential exceptions where the devices might be considered medically necessary, such as patients with small pedicles where pedicle screws could not be safely placed. NOTE: The name of the specific fixation device used for the procedure should be included in the clinical documentation.
9/1/2016 Reviewed. No changes.
2/1/2016 New medical Document. Interspinous fixation (fusion) devices are considered experimental, investigational and/or unproven for any indication, including but not limited to use: In combination with interbody fusion, or alone for decompression in patients with spinal stenosis.

Archived Document(s):

Title:Effective Date:End Date:
Interspinous Fixation (Fusion) Devices09-01-201711-14-2018
Interspinous Fixation (Fusion) Devices02-01-201708-31-2017
Interspinous Fixation (Fusion) Devices09-01-201601-31-2017
Interspinous Fixation (Fusion) Devices02-01-201608-31-2016
Back to Top