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Jurisdiction

• Type: LCD
• Title: Percutaneous Minimally Invasive Fusion/Stabilization of the Sacroiliac Joint for the Treatment of Back Pain
• ID Number: L36000
• Medicare Administrative Contractors (MACs): J5 - Wisconsin, J8 - Wisconsin . Physicians Service Insurance Corporation
• Applicable States/Territories: IA, KS, MO, NE | IN, MI

• Type: LCA
• Title: Lumbar Spinal Fusion for Instability and Degenerative Disc as Conditions
• ID Number: L33382, A57654 —
• Medicare Administrative Contractors (MACs): JJ-PalmettoGBA | (Part A/B MAC) JM- Palmetto GBA (Part A/B MAC), IN - First Coast Service Options, Inc. (Part A/B MAC)
• Applicable States/Territories: AL, GA, TN | NC, SC, VA, WV | FL, PR, U.S. VI

Description

Spinal fusion, also known as spinal arthrodesis, is a surgical treatment for cervical (neck) or lumbar or thoracic (back) pain that fuses (unites) two or more vertebral bodies in the spinal column. The most common goal of spinal fusion surgery is to restrict spinal motion in order to relieve painful symptoms. Spinal fusion surgery is generally performed to treat degenerative disc disease (DDD), spondylolisthesis, trauma resulting in spinal nerve compression, scoliosis or kyphosis (abnormal spinal curvatures) and vertebral instability caused by infections or tumors. Spinal fusion may be performed using a minimally invasive or open approach. All fusion surgeries involve the placement of a bone graft between the vertebrae. The bone graft may be taken either autograft (from another bone in the individual) or allograft (bone from a bone bank). Bone graft substitute products may be used instead of an autograft or allograft. These products may be composed of synthetic materials, bone morphogenetic protein or recombinant human bone morphogenetic protein, and are designed to facilitate growth of bone to accomplish the fusion. Spinal fusion surgeries may also be performed in conjunction with a laminectomy, laminotomy, foraminectomy, foraminotomy, laminoplasty, corpectomy or facetectomy procedure. The spine may be approached and the graft placed from either an anterior (front of the body), posterior (back of the body), lateral (from the side) or by a combination anterior/posterior approach. A fusion can be performed with or without the use of supplemental hardware such as plates, screws or cages that serve as an internal splint while the bone graft heals. However, current practice most commonly employs hardware in addition to the grafts.

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Interlaminar lumbar instrumented fusion (ILIF), utilizing an interspinous process fusion device, has been proposed as an alternative to traditional fusion procedures. Devices used for ILIF are interlaminar or interspinous fixation devices, rather than traditional hardware (ie, plates, screws or cages). These devices are described as non-pedicle supplemental fixation systems and are attached to the spinous processes of adjoining vertebrae.

They differ from interspinous process decompression spacers and nonrigid spinal stabilization devices in that they are intended to be used as an adjunct to interbody vertebral fusion and allow the use of a bone graft (or bone graft substitute), rather than stand-alone procedures. Examples of these devices include, but may not be limited to, the Alpine XC System, Aspen MIS Fusion System, Aurora Zip MIS Interspinous Fusion System, Aurora Zip Ultra Interlaminar Fixation Implant, BacFus, coflex-F, InSpan Spinous Process Plate System, PrimaLOK SP, SP-Fix and StabiLink MIS Spinal Fixation System.

A proposed minimally invasive approach to spinal fusion uses a laparoscope (endoscope) and purports to decrease injury to surrounding tissues and promote a quicker recovery time. There are several types of these procedures/techniques including, but may not be limited to, direct lateral interbody fusion (DLIF), extreme lateral interbody fusion (XLIF), laparoscopic anterior lumbar interbody fusion (LALIF) and minimally invasive transforaminal lumbar interbody fusion (MITLIF).

Alternative, minimally invasive (percutaneous) approaches have been proposed for lumbar fusion. One such procedure utilizes a percutaneous axial or presacral lumbar interbody fusion including, but may not be limited to, the AxiaLIF+ (Axial Lumbar Interbody Fusion System). Another procedure proposed as an alternative to traditional spinal fusion is the OptiLIF procedure, which is a percutaneous transforaminal lumbar interbody fusion (TLIF). It utilizes the OptiMesh expandable interbody fusion system, which consists of an expandable interbody mesh cage to hold bone graft material, and instruments for implanting the cage.

Facet joint replacement/implant is a relatively new device/procedure for facet joint degeneration, which has been proposed to be used in conjunction with a spinal fusion or as a stand-alone procedure. When performed as a stand-alone procedure, it is purported as a system for facet joint reconstruction, matching the joint shape and size in order to provide pain relief, normal motion and stability. Examples include, but may not be limited to, the Acadia Facet Replacement System (which is not US Food & Drug Administration [FDA] approved) and the TOPS Spinal Arthroplasty System (currently limited to investigational use).

Sacroiliac joint (SIJ) fusion has been suggested as a possible treatment option for an individual with low back pain due to sacroiliac joint dysfunction or syndrome. This procedure may be performed by an open surgical approach or as a minimally invasive procedure in order to place plates and/or screws to develop a bony fusion across the SIJ for stabilization. The iFUSE Implant System consists of small triangular titanium implants placed across the sacroiliac joint (may be referred to as a lateral transiliac approach) to stabilize and fuse it via a percutaneous, minimally invasive approach with use of fluoroscopy to visualize placement of the implants.

The triangular shape of the implants helps minimize rotation while also maximizing surface area contact across the SIJ. Other minimally invasive systems used for SIJ fusion include, but may not be limited to, the following:

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• Firebird SI Fusion System
• Genesys Sacroiliac Joint Fusion System
• LinQ
• Prolix SI Fusion System
• Rialto SI Fusion System
• Sacrofuse
• SIJFuse Sacroiliac Joint Fusion Device System
• SI-DESIS
• Siconus SI Joint Fixation System
• SIFix
• SIJoin
• Silex Sacroiliac Joint System
• SILO TFX MIS Sacroiliac Joint Fixation System
• SImmetry Sacroiliac Joint Fusion System
• SIros Lateral 3D Printed SI Joint System
• TransLoc 3D
• Triton Sacroiliac Joint Fixation System

The LigaPass 2.0 Ligament Augmentation System has been proposed as an alternative to pedicle screws, hooks or as an adjunct to other posterior spinal instrumentation in spinal surgeries where ligament augmentation is needed. It consists of a polyester band and titanium connectors that lace around the vertebra to purportedly mimic muscle and ligament functionality and stability.

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:

Spinal Fusion Surgery

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

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