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Humana Spinal Fusion Surgery Form


Spinal Fusion Surgery

Notes: General criteria must be met for coverage. In the case of cervical spinal fusion, additional criteria, including radiographic evidence, must also be met.

Indications

(509942) Has the patient abstained from nicotine use for at least 6 weeks prior to the anticipated surgery date? 
(509943) Can the patient provide documentation of nicotine cessation via a negative lab test report for cotinine within 30 days of the planned surgical procedure? 
(509944) Will spinal instrumentation devices be used according to FDA-approved indications effective on the date of service? 

Effective Date

12/14/2023

Last Reviewed

NA

Original Document

  Reference



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 Surgery Effective Date: 12/14/2023

Revision Date: 12/14/2023
Review Date: 12/14/2023

Policy Number: HUM-0477-026

Page: 1 of 50

Note: 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.

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Humana's Documents

For information regarding bone graft substitute products, please refer to Bone Graft Substitutes Medical Coverage Policy.

Spinal fusion surgeries may also be performed in conjunction with a laminectomy, laminotomy, foraminectomy, foraminotomy, laminoplasty, corpectomy or facetectomy procedure. For information regarding these spinal surgeries, please refer to Spinal Decompression Surgery Medical Coverage Policy.

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.

Alternative Procedures and Approaches

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 (i.e., 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. (Refer to Coverage Limitations section)

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), Spinal Fusion Surgery Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0477-026 Page: 3 of 50Note: 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.and minimally invasive transforaminal lumbar interbody fusion (MITLIF). (Refer to Coverage Limitations section)

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. (Refer to Coverage Limitations section)

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), ION Facet Screw Spinal Fixation Implant and the TOPS Spinal Arthroplasty System. (Refer to Coverage Limitations section)

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:Spinal Fusion Surgery Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0477-026 Page: 4 of 50Note: 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.

  • 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
  • Siber Ti 3D
  • Siconus SI Joint Fixation System
  • SIFix
  • SIJoin
  • Silex Sacroiliac Joint System
  • SILO TFX MIS Sacroiliac Joint Fixation System
  • SImmetry Sacroiliac Joint Fusion System
  • SIros 3D Printed SI Joint System (lateral, oblique, posterior, hybrid)
  • TiLink-L
  • TiLink-P
  • TransLoc 3D
  • Triton Sacroiliac Joint Fixation System (Refer to Coverage Limitations section)

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. (Refer to Coverage Limitations section)

For information regarding spinal procedures other than fusion, please refer to:

  • Related Procedure: Artificial intervertebral disc replacement
  • Medical Coverage Policy: Artificial Intervertebral Disc Replacement
  • Related Procedure: Interspinous process decompression spacers
  • Medical Coverage Policy: Interspinous Process Decompression Spacers
  • Related Procedure: Nonrigid spinal stabilization devices
  • Medical Coverage Policy: Dynamic Spinal Stabilization Devices

Spinal Fusion Surgery Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0477-026 Page: 5 of 50

Note: 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.

Coverage Determination

Services provided by a psychiatrist, psychologist or other behavioral health professionals are subject to the provisions of the applicable behavioral health benefit.

General Criteria for Spinal Fusion

Humana members may be eligible under the Plan for spinal fusion surgery when the following criteria are met:

  1. Individual must be nicotine-free for 6 weeks prior to the date of the anticipated surgery (unless the surgical procedure is emergent); AND
  2. Individual who has been a nicotine user prior to the anticipated surgery must provide documentation of nicotine cessation, as evidenced by negative lab test report for cotinine, to have been performed within 30 days of the planned surgical procedure; AND
  3. The use of spinal instrumentation devices (eg, cages, pedicle screws, plates, rods) when the medical necessity criteria for the procedures are met AND the device is used according to the FDA-approved indications effective on the date of service (refer to Coverage Limitations section regarding custom [personalized] implants/cages)
Cervical Fusion

Humana members may be eligible under the Plan for cervical spinal fusion when the general criteria for spinal fusion AND the following criteria are met, as confirmed by radiographic evidence (computed tomography [CT] scan or magnetic resonance imaging [MRI]):

  • Acute instability with ONE of the following:
    • Acute disc herniation; OR
    • Acute radicular weakness or numbness; OR
  • As a concurrent stabilization procedure with a corpectomy or laminectomy; OR

Spinal Fusion Surgery Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0477-026 Page: 6 of 50

Note: 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.

  • Cervical instability in skeletal dysplasia or connective tissue disorders (eg, severe kyphosis with head-drop syndrome); OR
  • Cervical instability with Down syndrome; OR
  • Degenerative spinal segment adjacent to a previously decompressed or fused spinal segment with ONE of the following:
    • Symptomatic myelopathy corresponding to the adjacent level, as evidenced by the following:
      • Clinical symptoms including, but may not be limited to, bowel or bladder incontinence, clumsiness of the hands, frequent falls, urinary urgency; AND
      • Objective neurologic signs including, but may not be limited to, hyperreflexia, Hoffmann sign, increased tone or spasticity; OR
    • Symptomatic radiculopathy* corresponding to the adjacent level that has persisted despite 12 consecutive weeks of conservative treatment under the direction of a healthcare professional within the past 12 months, including all of the following:
      • Activity/lifestyle modification; AND
      • Epidural steroid injections or facet joint/medial branch nerve blocks if medically appropriate and not contraindicated (for information regarding coverage determination/limitations, please refer to Injections for Chronic Pain Conditions Medical Coverage Policy); AND
      • Medications (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], non- narcotic analgesics) if medically appropriate and not contraindicated; AND
      • Physical therapy (PT), including home exercise program (HEP) (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); OR
  • Spinal Fusion Surgery Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0477-026 Page: 7 of 50
  • 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.
  • Degenerative spondylosis with kyphosis that is causing spinal cord compression; OR
  • Disc herniation with radiculopathy* and BOTH of the following:
    • Failure of 12 consecutive weeks of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
      • Activity/lifestyle modification; AND
      • Epidural steroid injections if medically appropriate and not contraindicated (for information regarding coverage determination/limitations, please refer to Injections for Chronic Pain Conditions Medical Coverage Policy); AND
      • Medications (eg, NSAIDs, non-narcotic analgesics) if medically appropriate and not contraindicated; AND
      • PT, including HEP (for information regarding coverage determination/ limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); AND
    • Unremitting radicular pain* secondary to nerve root compression; OR
  • Iatrogenic instability is probable due to ANY of the following:
    • Multilevel facetectomy or laminectomy is anticipated to be, or is, performed; OR
    • Single-level complete facetectomy on 1 side; OR
    • Single-level facetectomy if greater than 50% of both facet joints are removed; OR
  • Klippel-Feil syndrome; OR
  • Multilevel spondylotic myelopathy, as evidenced by ONE of the following:

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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.

  • Corresponding clinical symptoms (including, but may not be limited to, bowel or bladder incontinence, clumsiness of hands, frequent falls, urinary urgency) and corresponding objective neurologic signs (including, but may not be limited to, hyperreflexia, Hoffmann sign, increased tone or spasticity); OR
  • Diagnostic imaging positive for cord compression from either a herniated disc or osteophyte; OR
  • Multilevel spondylotic radiculopathy*; OR
  • Ossification of the posterior longitudinal ligament up to and including 3 levels; OR
  • Spinal abscess/infection; OR
  • Spinal tumor (primary or metastatic) with associated cord compression, pathologic fracture or instability; OR
  • Subluxation or compression due to rheumatoid arthritis; OR
  • Symptomatic pseudoarthrosis (nonunion from a prior spinal fusion) and ALL of the following:
    • At least 12 months have elapsed since the prior fusion procedure, unless there is evidence of hardware failure (breakage or loosening); AND
    • Individual experienced improvement in pain and symptoms following the original fusion procedure; AND
    • Symptoms, corresponding to the level of the pseudoarthrosis, have persisted despite 12 consecutive weeks of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
      • Activity/lifestyle modification; AND
      • Epidural steroid injections or facet joint/medial branch nerve blocks if medically appropriate and not contraindicated (for information regarding coverage determination/limitations, please refer to Injections for Chronic Pain Conditions Medical Coverage Policy); AND
      • Medications (eg, NSAIDs, non-narcotic analgesics) if medically appropriate and not contraindicated; AND
      • PT, including HEP (for information regarding coverage determination/ limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); OR
  • Symptomatic spondylosis with instability, as evidenced radiographically by ONE of the following:
    • Greater than 4 mm of motion (subluxation) between the tips of the spinous processes on dynamic views; OR
    • Sagittal plane angulation of greater than 11 degrees between adjacent segments; OR
    • Subluxation or translation of greater than 3.5 mm on static lateral views or dynamic radiographs; OR
  • Traumatic disc herniation; OR
  • Unstable injury such as atlas and axis fracture, burst fracture or facet fracture with dislocation; OR
  • Other symptomatic instability or cord or root compression and BOTH of the following:
    • Unresponsive to 12 consecutive weeks of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
      • Activity/lifestyle modification; AND

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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.

Spinal Fusion Surgery Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0477-026 Page: 10 of 50

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.

Cervical (neck) radicular pain (radiculopathy) typically radiates down one or both arms and is associated with segmental nerve root impingement.

Lumbar Fusion

Humana members may be eligible under the Plan for lumbar fusion surgery when the general criteria for spinal fusion AND the following criteria are met, as confirmed by radiographic evidence (CT scan or MRI):

  • Axial (discogenic) low back pain secondary to degenerative disc disease and ALL of the following:
    • Body mass index (BMI) less than 40; AND
    • Chronic, unremitting back pain and radiculopathy for at least 1 year; AND
    • Failure of 6 consecutive months of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
  • Spinal Fusion Surgery Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0477-026 Page: 11 of 50
  • Activity/lifestyle modification; AND
  • Cognitive behavioral therapy (CBT); AND
  • Epidural steroid injections or facet joint/medial branch nerve blocks if medically appropriate and not contraindicated (for information regarding coverage determination/limitations, please refer to Injections for Chronic Pain Conditions Medical Coverage Policy); AND
  • Medications (eg, NSAIDs, non-narcotic analgesics) if medically appropriate and not contraindicated; AND
  • PT, including HEP and core stabilization exercises (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); OR
  • Iatrogenic instability is probable due to ANY of the following:
    • Multilevel facetectomy or laminectomy is anticipated to be, or is, performed; OR
    • Resection of 1 of the following anterior structures:
      • Intervertebral disc (complete/total discectomy); OR
      • Ligament (resection or transection through the anterior longitudinal ligament); OR
      • Vertebral body (one-third or more of a vertebral body is resected); OR
    • Single-level complete facetectomy on 1 side; OR
    • Single-level facetectomy if greater than 50% of both facet joints are removed; OR
  • Early-onset scoliosis in an individual less than 10 years of age and ALL of the following:
  • Spinal Fusion Surgery Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0477-026 Page: 12 of 50
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  • Spinal curvature 40 degrees or greater; AND
  • Deterioration in level of function (eg, pulmonary compromise) that has persisted despite 6 consecutive months of conservative treatment under the direction of a healthcare professional within the past 12 months including, but not limited to, bracing; OR

Idiopathic adolescent scoliosis in an individual 10 years of age or older and ALL of the following:

  • Signs and symptoms (eg, shoulder height asymmetry, uneven leg length, uneven waist) that have persisted despite 6 consecutive months of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
  • Bracing; AND
  • Medication (eg, NSAIDs, non-narcotic analgesics) if medically appropriate and not contraindicated; AND
  • PT, including HEP (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); AND
  • Spinal curvature 45 degrees or greater; OR

Severe degenerative scoliosis with ANY of the following:

  • Spinal curvature (Cobb angle) 45 degrees or greater, with persistent neurogenic claudication that has persisted despite 6 consecutive months of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
  • Activity/lifestyle modification; AND
  • Bracing; AND
  • Medication (eg, NSAIDs, non-narcotic analgesics) if medically appropriate and not contraindicated; AND
  • PT, including HEP (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); OR
  • Persistent significant radicular** pain or weakness that has persisted despite 6 consecutive months of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
  • Activity/lifestyle modification; AND
  • Bracing; AND
  • Medications (eg, NSAIDs, non-narcotic analgesics) if medically appropriate and not contraindicated; AND
  • PT, including HEP (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); OR
  • Progression of deformity to greater than 50 degrees with loss of function; OR
  • Spinal abscess/infection; OR
  • Spinal dislocation; OR
  • Spinal fracture with instability or neural compression; OR
  • Spinal stenosis associated with spondylolisthesis in an individual with a BMI of less than 40, with ONE of the following:
  • Progressive or severe symptoms of neurogenic claudication; OR

Spinal Fusion Surgery Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0477-026 Page: 13 of 50

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.

Spinal Fusion Surgery Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0477-026 Page: 14 of 50

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.

  • Back pain, neurogenic claudication symptoms or radicular pain** associated with ALL of the following:
    • Significant functional impairment; AND
    • Listhesis demonstrated on plain X-rays; AND
    • Central, lateral recess or foraminal stenosis demonstrated on imaging (eg, MRI, CT scan, myelography); AND
    • Failure of 12 consecutive weeks of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
  • Spinal tuberculosis; OR
  • Spinal tumor; OR
  • Spondylolysis (pars interarticular fracture) or isthmic spondylolisthesis in an individual with a BMI of less than 40, with ONE of the following:
    • Multilevel spondylolysis; OR
  • Progressive deformity with neurologic compromise; OR
  • Symptomatic high-grade (50% or greater anterior slippage) spondylolisthesis demonstrated on plain X-rays; OR
  • Symptomatic low-grade spondylolisthesis after 6 to 12 consecutive months of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
    • Activity/lifestyle modification; AND
    • Cognitive behavioral therapy (CBT); AND
    • Medications (eg, NSAIDs, non-narcotic analgesics) if medically indicated and not contraindicated; AND
    • PT, including HEP and core stabilization exercises (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); OR
  • Symptomatic pseudoarthrosis (nonunion from a prior spinal fusion) and ALL of the following:
    • At least 12 months have elapsed since the prior fusion procedure, unless there is evidence of hardware failure (breakage or loosening); AND
    • Individual experienced improvement in pain and symptoms following the original fusion procedure; AND
    • Symptoms, corresponding to the level of the pseudoarthrosis, have persisted despite 12 consecutive weeks of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
      • Activity/lifestyle modification; AND
      • Spinal Fusion Surgery Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0477-026 Page: 16 of 50

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.

Lumbar (low back) radicular pain (radiculopathy) typically radiates to the level of the knee or more distally and is associated with segmental nerve root impingement.

Percutaneous Minimally Invasive Sacroiliac Joint Fusion

Humana members may be eligible under the Plan for percutaneous minimally invasive SIJ fusion using triangular titanium implants (iFuse Implant System), via a lateral transiliac approach with placement of the implant across the SIJ, when the general criteria for spinal fusion AND ALL of the following criteria are met:

  • Absence of contraindications; AND
  • Chronic low back pain due to sacroiliac joint dysfunction; AND
  • Failure of 6 consecutive months of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
    • Activity/lifestyle modification; AND
    • Bracing; AND
    • Medications (eg, NSAIDs, non-narcotic analgesics) if medically appropriate and not contraindicated; AND
    • PT, including HEP and core stabilization exercises (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); AND
  • Imaging studies exclude the presence of other causes for SIJ dysfunction/pain including, but not limited to:
    • Acute fracture
    • Concomitant hip osteoarthritis
    • Destructive SIJ lesions (infection, tumors)
    • Inflammatory arthropathy
    • Lumbar spine degenerative conditions or neural compression; AND
  • Positive response (reproduction of individual’s typical SIJ pain) to at least 3 of the following provocative tests/maneuvers:
    • Compression test
    • Distraction test
    • FABER test (also referred to as Patrick test)
    • Gaenslen’s test
    • Thigh thrust test (also referred to as posterior pelvic pain provocation); AND
  • Positive response to 2 diagnostic, image-guided SIJ injections, at intervals of no sooner than 2 weeks (a positive response is defined as at least an 80% reduction in pain and/or symptoms)

Sacroiliac Joint Fusion (Open Surgical Approach)

Humana members may be eligible under the Plan for open sacroiliac joint fusion surgery when the general criteria for spinal fusion are met AND for the following indications, as confirmed by radiographic evidence (CT scan or MRI):

  • Fractures (eg, pelvic ring fracture, sacral fracture); OR
  • Pelvic instability (eg, dislocation); OR
  • Primary sacral tumors; OR
  • Sacroiliac joint infection (eg, osteomyelitis); OR

Spinal Fusion Surgery Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0477-026 Page: 17 of 50

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.

Spinal Fusion Surgery Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0477-026 Page: 18 of 50

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.

  • When performed as part of a multisegmental long fusion for correction of spinal deformity (eg, scoliosis, spondylolysis)

Thoracic Fusion

Humana members may be eligible under the Plan for thoracic fusion surgery when the general criteria for spinal fusion AND the following criteria are met, as confirmed by radiographic evidence (CT scan or MRI):

  • Degenerative spondylosis with kyphosis that is causing spinal cord compression; OR
  • Early-onset scoliosis in an individual less than 10 years of age and ALL of the following:
    • Spinal curvature 40 degrees or greater; AND
    • Deterioration in level of function (eg, pulmonary compromise) that have persisted despite 6 consecutive months of conservative treatment under the direction of a healthcare professional within the past 12 months including, but not limited to, bracing; OR
  • Idiopathic adolescent scoliosis in an individual 10 years of age or older and ALL of the following:
    • Signs and symptoms (eg, shoulder height asymmetry, uneven leg length, uneven waist) that have persisted despite 6 consecutive months of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
      • Bracing; AND
      • Medication (eg, NSAIDs, non-narcotic analgesics) if medically appropriate and not contraindicated; AND
      • PT, including HEP (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); AND
    • Spinal curvature 45 degrees or greater; OR
  • Severe degenerative scoliosis with ANY of the following:
    • Spinal curvature (Cobb angle) 45 degrees or greater, with persistent neurogenic claudication that has persisted despite 6 consecutive months of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
      • Activity/lifestyle modification; AND
      • Bracing; AND
      • Medication (eg, NSAIDs, non-narcotic analgesics) if medically appropriate and not contraindicated; AND
      • PT, including HEP (for information regarding coverage determination/ limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); OR
    • Persistent significant radicular** pain or weakness that has persisted despite 6 consecutive months of conservative treatment under the direction of a healthcare professional within the past 12 months, including ALL of the following:
      • Activity/lifestyle modification; AND
      • Bracing; AND
      • Medications (eg, NSAIDs, non-narcotic analgesics) if medically appropriate and not contraindicated; AND
      • PT, including HEP (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); AND

Spinal Fusion Surgery Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0477-026 Page: 19 of 50

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.

Spinal Fusion Surgery Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0477-026 Page: 20 of 50

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.

  • PT, including HEP (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); OR
  • Progression of deformity to greater than 50 degrees with loss of function; OR
  • Spinal abscess or infection; OR
  • Spinal fracture with instability or neural compression; OR
  • Spinal tumor

Coverage Limitations

A minimally invasive (laparoscopic or endoscopic) approach to spinal fusion at the cervical, thoracic or lumbar level is considered integral to the primary procedure and not separately reimbursable on the part of the surgeon or the facility. This would include, but may not be limited to, DLIF, LALIF, MITLIF and/or XLIF.

Humana members may NOT be eligible under the Plan for spinal fusion surgery (cervical, lumbar or thoracic levels) for any indications other than those listed above. All other indications are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for percutaneous minimally invasive sacroiliac joint fusion using triangular titanium implants (iFuse Implant System) for any indications other than those listed above, including the following contraindications:

  • Acute, traumatic instability of the SIJ; OR
  • Fractures (including sacral insufficiency fractures); OR
  • Generalized pain behavior (eg, somatoform disorder); OR
  • Generalized pain disorder (eg, fibromyalgia); OR
  • Infection (localized or systemic [sepsis]); OR
  • Osteoporosis or osteopenia; OR
  • Systemic arthropathy (eg, ankylosing spondylitis, rheumatoid arthritis); OR
  • Tumor involving the sacrum or SIJ

Spinal Fusion Surgery Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0477-026 Page: 21 of 50

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 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.

Humana members may NOT be eligible under the Plan for sacroiliac joint fusion via an open surgical approach for any indications other than those listed above including, but not limited to:

  • Low back pain; OR
  • Sacroiliac joint dysfunction/syndrome

All other indications are considered not medically necessary as defined in the member’s individual certificate.

Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for the following spinal fusion procedures or devices for any indication/condition:

  • 3D-printed intervertebral cages/interbody fusion devices including, but may not be limited to, the Aries interbody fusion device, Blackhawk Ti, Dexasolo-L spinal fusion system, F3D lumbar interbody system, Flux-C cervical interbody device, ImpulseAM, Inspire Porous PEEK HAFuse, Klimt expandable lumbar interbody fusion cage, Siber Ti, Stronghold C, Ti-Largo, WaveForm A Interbody system, WaveForm C Interbody system and WaveForm TA system; OR
  • Custom (personalized) anterior and lateral interbody cage (implantable) including, but may not be limited to, the Aprevo Patient-Specific Interbody Implant; OR
  • Facet joint replacement/implants including, but may not be limited to, the Acadia Facet Replacement System (AFRS), ION Facet Screw spinal fixation implant and TOPS spinal arthroplasty system; OR
  • Interlaminar lumbar instrumented fusion (ILIF); OR
  • Spinal Fusion Surgery Effective Date: 12/14/2023
  • Revision Date: 12/14/2023
  • Review Date: 12/14/2023
  • Policy Number: HUM-0477-026 Page: 22 of 50

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.

  • Isolated facet joint fusion (when performed as a stand-alone procedure [without a decompression procedure]); OR
  • Ligament augmentation with spinal deformity surgery including, but may not be limited to, the LigaPass 2.0 system; OR
  • OptiLIF procedure with use of the Optimesh Expandable Interbody Fusion System; OR
  • Percutaneous axial or presacral lumbar interbody fusion including, but may not be limited to, AxiaLIF+ (Axial Lumbar Interbody Fusion System); OR
  • Posterior vertebral joint replacement (lumbar spine); OR
  • Sacroiliac joint fusion via a minimally invasive approach other than those listed above (in Coverage Determination section) including, but may not be limited to, use of the following devices/implants:
    o Firebird SI Fusion System; OR
    o Genesys Sacroiliac Joint Fusion System; OR
    o Insertion of both a lateral transfixing and an intra-articular (nontransfixing) implant in the same operative procedure (may also be referred to as a hybrid SIJ fusion procedure); OR
    o LinQ; OR
    o Percutaneous intra-articular implant (without placement of transfixation device); OR
    o Posterior or dorsal approach/procedure (including those using only bone grafts and no internal fixation devices); OR
    o Prolix SI Fusion System; OR
    o Rialto SI Fusion System; OR
  • Spinal Fusion Surgery Effective Date: 12/14/2023
  • Revision Date: 12/14/2023
  • Review Date: 12/14/2023
  • Policy Number: HUM-0477-026 Page: 23 of 50

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.

  • Sacrofuse SIJFuse; OR
  • SI-DESIS; OR
  • Siber Ti 3D; OR
  • Siconus SI Joint Fixation System; OR
  • SIFix; OR
  • SIJoin; OR
  • Silex Sacroiliac Joint System; OR
  • SILO TFX MIS Sacroiliac Joint Fixation System; OR
  • SImmetry Sacroiliac Joint Fusion System; OR
  • SIros 3D Printed SI Joint System; OR
  • TiLink-L sacroiliac joint fusion system; OR
  • TiLink-P sacroiliac joint fusion system; OR
  • TransLoc 3D; OR
  • Triton Sacroiliac Joint Fixation System; OR

Use of interspinous fixation/non-pedicle supplemental fixation devices including, but may not be limited to, the Alpine XC, Aspen MIS, Aurora ZIP, Aurora Zip Ultra Interlaminar Fixation Implant, BacFus, coflex-F, InSpan, PrimaLOK SP, SP-Fix and StabiLink MIS

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.

Spinal Fusion Surgery Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0477-026 Page: 24 of 50
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 spinal fusion surgery procedures performed with systems using artificial intelligence or augmented reality guidance including, but not limited to, the Surgalign Holo Portal surgical guidance system or the Caduceus S augmented reality spine navigation system. 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.

Background

Additional information about degenerative disc disease (DDD), sacroiliac joint dysfunction/syndrome, scoliosis, spondylolisthesis and other spinal (back) disorders may be found from the following websites:

  • American Academy of Orthopaedics
  • National Library of Medicine
  • North American Spine Society

Medical Alternatives

Alternatives to cervical spinal fusion surgery include, but may not be limited to, the following:

Alternatives to lumbar spinal fusion surgery include, but may not be limited to, the following:

Spinal Fusion Surgery Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0477-026 Page: 25 of 50
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.

  • Radiation therapy and/or chemotherapy for a spinal tumor

Alternatives to Open Sacroiliac Joint Fusion Surgery

Alternatives to Thoracic Spinal Fusion Surgery

  • Radiation therapy and/or chemotherapy for a spinal tumor

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