Humana Dynamic Spinal Stabilization Devices - Medicare Advantage Form

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Description

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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 is fixed or attached to the lumbar or sacral spine and for when the device is 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. 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 Dynamic Spinal Stabilization Devices Page: 3 of 4 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.

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:

Dynamic Spinal Stabilization Devices

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider MCG Guidelines.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage