Description

Dynamic spinal stabilization devices are proposed as a way to immobilize and stabilize spinal segments in a skeletally mature individual as an adjunct to fusion in the treatment of chronic instabilities or deformities of the thoracic, lumbar and sacral spine including, but not limited to, degenerative spondylolisthesis (with objective evidence of neurologic impairment) or previous failed spinal fusion. These devices are also approved by the US Food & Drug Administration (FDA) for spinal fusion with autogenous graft only, when the device fixed or attached to the lumbar or sacral spine and for when the device removed after the development of a solid fusion mass.

These devices attach to the spine via the implantation of two titanium alloy screws per vertebra. The protruding ends of the screws, which have been implanted into two or three adjacent vertebrae, are attached to polyethylene-terephthalate cords.

Dynamic Spinal Stabilization Devices Effective Date: 06/22/2023

Revision Date: 06/22/2023

Review Date: 06/22/2023

Policy Number: HUM-0393-017

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

These cords are surrounded by a set of solid polycarbonate urethane spacers. The system is designed to stabilize the spine by the cords pulling against the spinal motions that separate the vertebrae. At the same time, the spacers push against the spinal motions that compress the vertebrae. These devices differ from traditional instrumentation used during spinal fusion, as they are nonrigid and allow some movement of the spine segments. An example of dynamic spinal stabilization devices includes, but may not be limited to, the Dynesys Stabilization System.

The Dynesys Stabilization System has also been proposed for immobilization and stabilization of spinal segments without a spinal fusion procedure; at this time, the FDA has not approved this application.

The Zimmer DTO Implant, considered a hybrid device, combines the Dynesys Dynamic Stabilization System with the rigid stabilization of the OPTIMA ZS Spinal System. This device is an attempt to offer a new segmental solution for treating degenerative lumbar spine pathologies with different stages of degeneration at contiguous levels.

Dynamic spinal stabilization devices may also be semi-rigid in design. These devices purportedly allow less spinal movement than the nonrigid, but more than traditional spinal fusion instrumentation.

The FDA granted its Breakthrough Device Designation for the LimiFlex Dynamic Sagittal Tether (also referred to as the Paraspinous Tension Band). It consists of two titanium coil springs attached to each other by polyethylene straps, which form a loop; the loop is wrapped around the spinal processes and applies force to maintain lordosis and stabilize the spine. The LimiFlex is implanted in conjunction with a decompression procedure via a minimally invasive approach and has been proposed as an alternative to spinal fusion.

The coflex Interlaminar Stabilization Device, while it does provide dynamic spinal stabilization, differs somewhat from the other devices in that it does not use cords to help with motion preservation. The coflex device is positioned between two adjacent spinous processes after a decompression of spinal stenosis has been performed (during the same surgical procedure). It purportedly provides stability while also still allowing some functional spinal motion and is proposed as an alternative to spinal fusion.

Vertebral body tethering, similar to dynamic spinal stabilization, has been proposed as a treatment for scoliosis. In this procedure, as in dynamic spinal stabilization, the screws are implanted into each side of the vertebra, which are then attached to polyethylene-terephthalate cords. Where the procedures differ, however is the theory of growth modulation – partially restraining one side of the spine (pulling one cord tighter than the other) to purportedly allow growth on the other side, to reverse the abnormal scoliosis growth pattern in the anterior thoracic (upper) spine. Examples of devices used for this procedure include, but may not be limited to, the MIScoli System and The Tether Vertebral Body Tethering System. A variation of these devices is the Auctus VBT system, which was granted an FDA Breakthrough Device Designation; it utilizes an external magnet controller for nonsurgical adjustment of the spinal curvature over time.

For information regarding spinal fusion, please refer to Spinal Fusion Surgery Medical Coverage Policy.

For information regarding interspinous decompression, please refer to Interspinous Process Decompression Spacers Medical Coverage Policy.

Coverage Determination

Humana members may NOT be eligible under the Plan for dynamic spinal stabilization devices including, but not limited to, the following, for any indication:

• coflex Interlaminar Stabilization Device
• Dynesys Stabilization System
• LimiFlex Dynamic Sagittal Tether
• Zimmer DTO Implant

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Dynamic Spinal Stabilization Devices Effective Date: 06/22/2023

Revision Date: 06/22/2023

Review Date: 06/22/2023

Policy Number: HUM-0393-017 Page: 4 of 8

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for vertebral body tethering for scoliosis or any other indication, with any device including, but may not be limited to:

• Auctus VBT system
• MIScoli system
• The Tether

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about back pain, scoliosis and spondylolisthesis may be found from the following websites:

Background

• American Academy of Orthopaedic Surgeons
• National Institute of Arthritis and Musculoskeletal and Skin Diseases
• National Library of Medicine

Medical Alternatives

Alternatives to dynamic spinal stabilization devices include, but may not be limited to, the following:

• Back rest (no vigorous activity, lifting, etc.)
• Physical therapy (please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)
• Prescription drug therapy
• Spinal fusion (please refer to Spinal Fusion Surgery Medical Coverage Policy)
• Transcutaneous electrical nerve stimulation (TENS) (please refer to Electrical Stimulators for Pain and Nausea/Vomiting Medical Coverage Policy)

Dynamic Spinal Stabilization Devices Effective Date: 06/22/2023

Revision Date: 06/22/2023

Review Date: 06/22/2023

Policy Number: HUM-0393-017 Page: 5 of 8

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Alternatives to vertebral body tethering include, but may not be limited to, the following:

• Bracing (please refer to Orthotics Medical Coverage Policy)
• Physical therapy (please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)
• Spinal fusion (please refer to Spinal Fusion Surgery Medical Coverage Policy)
• TENS devices (please refer to Electrical Stimulators for Pain and Nausea/Vomiting Medical Coverage Policy)

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.