Spinal fusion, lumbar These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required for lumbar spine fusion for degenerative spine conditions for members age 18 and older.

Prior authorization is not required for lumbar fusion surgery for members under the age of 18.

Prior authorization is not required for fusion surgery of the cervical and thoracic areas of the spine for members of any age.

Prior authorization is generally not required for the type of access and associated instrumentation. Exceptions to this are noted in the Indications Not Covered Section.

The Designated Medical Spine Center (MSC) requirement will be applied to patients residing in regions where patients have access to a medical spine specialist. Patients residing outside of those regions will be exempt from seeing a designated medical spine specialist.

Coverage

Lumbar spinal fusion surgery is covered per the indications listed below. For the purpose of this policy, anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion and minimally invasive transforaminal lumbar interbody fusion (TLIF/MI-TLIF) and posterolateral gutter fusion, via open incision, are considered standard approaches. The following lateral approaches are considered equivalent to standard approaches: oblique lateral interbody fusion (OLIF), extreme lateral interbody fusion (XLIF) and direct lateral fusion (DLIF)

Standard spinal instrumentation or visualization technology is considered covered when all coverage criteria are met.

The patient is to be offered patient decision support.

Indications that are covered without prior authorization

Lumbar fusions are considered medically necessary for spinal instability associated with any of the following conditions, see also a partial list of ICD-10-CM codes that do not require prior authorization at the end of this document: • Epidural compression or vertebral destruction from tumor • Idiopathic scoliosis • Instability after debridement for infection • Neural compression after spinal fracture • Pseudarthrosis • Spinal infections (including tuberculosis, osteomyelitis, discitis) • Acute cauda equine OR acute spinal cord compression syndrome • Acute spinal fracture from documented trauma. • Intra-operative spinal instability

Indications that require prior authorization

Lumbar fusions for patients with one or more of the following: • Chronic low back • Radicular pain • Progressive objective neurological deficit

Coverage Criteria

Non-emergent lumbar spinal fusion is covered when the following criteria are met: 1. Member must have an evaluation at a Designated Medical Spine Center (MSC) prior to an orthopedic spine surgeon and neurosurgeon office consultation visit for specified lumbar spine surgery conditions; and 2. The visit summary notes from the MSC must be submitted with the request; and 3. Documentation by the operating surgeon demonstrating compliance with all the following criteria: A. Severe pain and disability limiting activities of daily living despite at least 8 weeks of intensive conservative treatments (such as exercise, activity modification or chiropractic care). Documentation of conservative treatments must correspond to the current episode of pain (within 6 months). o Conservative treatments must include physical therapy (PT), at least 4 visits over a course of 6 weeks or less. Active muscle conditioning is required as part of physical therapy. o Physical therapist’s notes must be submitted, or there must be a physician’s statement in the clinical documents that explains why physical therapy is contraindicated. o If a member is unable to complete physical therapy due to progressively worsening pain and disability, documentation in the physical therapists notes demonstrating this is required. The requirement for physical therapy will not be met if there is a failure to complete prescribed physical therapy for non-clinical reasons. B. A preoperative ODI that is greater than 40% or FOTO Status Score that is 21 – 60; C. A statement documenting the absence of untreated, underlying mental health conditions (including but not limited to psychological conditions or drug or alcohol abuse) that may be a contributor to the individual’s chronic , D. For only the clinical situations listed in i. -iii. below, a preoperative psychiatric/psychological evaluation conducted by a licensed psychiatrist, psychologist or other licensed mental health professional who has a working knowledge of the psychological issues involved in chronic pain syndromes. The intent of the evaluation is to include assessment such as the ability of the individual to understand the risks and realistic outcomes for the procedure and to comply with any behavioral changes as needed post-surgery, and also to document the absence of untreated mental illness contributing to chronic pain. The evaluation is required only in the following situations: i. Preoperative ODI score is 80% or higher, or a FOTO score less than 2; or ii. Lumbar fusion for treatment of chronic discogenic pain alone (degenerative disc disease without instability or deformity) or iii. Lumbar fusion for post-laminectomy/failed back surgery syndrome and 4. Fusion surgery is for treatment of chronic (defined as lasting equal to or longer than one year) discogenic back pain alone (degenerative disc disease without instability or deformity) with documented unremitting, discogenic pain and disability for at least 1 year; or 5. Fusion surgery is for treatment of a degenerative condition with spinal instability or spinal stenosis with documented unremitting pain and disability for at least 3 months associated with one or more of the following diagnoses: A. Spondylolisthesis; B. Spinal stenosis; C. Spinal stenosis when planned decompressive laminectomy surgery is likely to result in iatrogenic instability (greater than 50% facet joint excision bilaterally or entire facet on one side) D. Scoliosis (degenerative); E. Post laminectomy syndrome; or F. Progressive objective neurological deficit. 6. Confirmatory radiographic documentation (plain radiographs, advanced imaging studies), supporting the indication for the fusion surgery. Lumbar fusion for degenerative conditions, as listed under criterion 5 above, must provide documentation of spinal instability.

The use of recombinant human bone morphogenetic protein (rhBMP) 2 for lumbar fusion in adult patients is covered when criteria for the fusion are met and use is not outside of the following guidelines: 1. Performed for treatment of degenerative disc disease; 2. No more than Grade I spondylolisthesis at the involved level; 3. Fusion is for one level only from L2-S1 via open anterior approach; 4. Member has had inadequate response to at least 6 months of prior nonoperative treatment; 5. 1Member has inadequate autograft or contraindications to harvesting of bone autograft, provided that the member is skeletally mature; 6. There are no contraindications to rhBMP. Indications that are not covered

Lumbar fusions are not considered medically necessary or covered for the management of the following situations: 1. With initial primary laminectomy/ for nerve root decompression without documented instability; 2. Degenerative disc disease without documented spinal instability or spinal deformity, when involving three or more levels. 3. Absence of an evaluation at a Designated Medical Spine Center (MSC), when a MSC visit is required per the Spine surgical practice - low back pain office visits policy; and 4. All other conditions not listed under “Indications that are covered”

Lumbar fusions with any of the following devices or techniques are not covered because the following are considered experimental or investigational: 1. Anterior interbody fusion or implantation of intervertebral body fusion devices using a laparoscopic approach (LALIF) or (lap-ALIF) 2. Axial interbody approach (AxiaLif) 3. Dynamic spine stabilization device systems (Including but not limited to Dynesys Stabilization System, Zimmer DTO implant, Coflex Interlaminar stabilization device) 4. Interlaminar lumbar instrumented fusion (ILIF) 5. Interspinous fixation device (IFD) (examples include, but are not limited to, Aspen™, Coflex-F®, Minuteman® fusion plate, Medtronic CD Horizon Spire ™) as adjunct to fusion or as stand-alone procedure. 6. Minimally invasive fusion approaches using only indirect visualization (surgeon does not have visualization of the surgical site with the naked eye). This would include endoscopic fusion and percutaneous fusion techniques using video or fluoroscopic imaging alone. An example includes, but is not limited to, Oblique Lateral Lumbar Interbody Fusion (OLLIF). 7. The requested procedure includes the combined use of an artificial and spinal fusion surgery (i.e. hybrid surgery)

Definitions

Cauda equina syndrome – The cauda equina is a bundle of spinal nerve roots which spread out from the bottom of the spinal cord. Cauda equina syndrome is a group of symptoms that may happen if the cauda equina gets squeezed or damaged. The symptoms may include pain, numbness and weakness in the lower back and legs, foot drop, and problems controlling the bowels or bladder.

Designated Medical Spine Center – is a clinic with medical spine specialists whose focus is on the management of spine, neck and back problems using a variety of non-surgical treatment options.

Designated Medical Spine Specialist – is a provider with a specialty in Physical Medicine, providing care at a Designated Medical Spine Center.

Discogenic back pain – Back pain believed to be caused by the intervertebral discs, which are rubbery disc-shaped tissues located between each spinal bone (vertebrae).

Focus On Therapeutic Outcomes (FOTO) score - a physical functional status score. The patient answers questions regarding back pain and the ways it impairs daily activity. The answers are assigned numbers and used to calculate the FOTO score. A lower score indicates that more disability is affecting a person’s activities.

Iatrogenic instability – Vertebral bone movement and instability created during a surgery.

Lumbar spinal fusion - Surgery to permanently connect two or more vertebrae (spinal bones) in the lower spine, with the goal of stopping movement between them to create stability. Fusion surgery includes the placement of bone or bonelike materials between the vertebrae, and may also use metal rods, plates or screws to help heal the unstable vertebrae into one unit. Anterior lumbar spinal fusion (ALIF) surgery is performed by reaching the spine from the front of the body using a frontal incision or by approaching from the side of the body (e.g., eXtreme lateral interbody fusion [XLIF]; direct interbody fusion [DLIF]; oblique interbody fusion [OLIF]). Posterior lumbar spine (PLIF) surgery is performed by approaching the spine through a back incision or transforaminally through the opening between two spinal vertebrae (i.e. the foramen) where the nerves leave the spinal canal to enter the body (i.e.,transforaminal lumbar interbody fusion [TLIF]).

Neurogenic claudication – Sensations of pain, tingling, weakness or cramping in the back or legs that might be caused by pinching or inflammation of the nerves coming out from the spinal cord. The pain usually gets worse with standing or walking. Oswestry Disability Index (ODI) - a commonly used series of questions that measures back pain and how much the pain the limits a person’s ability to function in life activities. Each answer is given a score of 0-5, and used to calculate an ODI score. A higher score indicates that more disability is affecting a person’s activities.

Post laminectomy syndrome – also called failed back surgery syndrome, is a term used to describe a group of symptoms, such as pain, numbness, weakness which occur following a surgery on the spine, and may cause difficulty with daily activities.

Progressive objective neurological deficit – Symptoms such as back or leg numbness and weakness which have gotten worse over time.

Pseudoarthrosis – A non-joining or incomplete joining of the bones of the spine. It is sometimes the result of an attempted spinal fusion surgery.

Radiculopathy – pain felt going down the back and the leg or legs along with numbness, tingling or weakness. It may be caused when a nerve coming out of the spine is pinched or squeezed.

Recombinant human bone morphogenetic protein (rhBMP) 2 - a surgical material that may be placed between the vertebrae (spinal bones) during lumbar fusion surgery to promote growth and improve bone joining. It contains a protein found in human bone tissue, and may be used instead of or in addition to a bone autograft (bone taken from elsewhere in the patient’s own skeleton).

Scoliosis (degenerative) – is a condition caused when the bones in the spine start to degenerate (weaken, break down), creating an abnormal side-to-side curve in the spine. Sometimes this condition causes pain and difficulties with walking or standing, and sometimes there are no symptoms. This condition primarily affects older adults.

Scoliosis (idiopathic) - is an abnormal side-to-side curve in the spine with no known cause.

Spinal Stenosis – A narrowing of the central spinal cord canal or a narrowing of the spaces between the vertebrae (bones of the spine) where nerves pass through to join the spinal cord. Abnormal narrowing of the central spinal canal is often called central stenosis and narrowing of the smaller spaces where the spinal nerves enter the canal may be called foraminal stenosis. The narrowing is often caused by wear-and-tear changes related to arthritis or less commonly, is present at birth or caused by injury. The narrowing can cause bumps called bone spurs in the vertebral bones. It can also cause the rubbery discs between the vertebrae to shrink, making the space between the vertebrae tighter, which might pinch nerves. Spinal stenosis may result in symptoms such as pain and numbness in the back or legs. Most often, symptoms can be improved with non-surgical treatment, while some people may need surgery such as a laminectomy or spinal fusion.

Spondylolisthesis - A condition in which two spinal vertebral bones no longer line up with each other. One of the vertebrae “slips” forward in relation to another one. This condition can cause low back or leg pain, or cause no symptoms at all.

Codes

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The following CPT codes require prior authorization, except for the ICD-10-CM diagnosis codes listed below: Codes Description 22533 Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar 22534 Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression); thoracic or lumbar, each additional vertebral segment (List separately in addition to code for primary procedure) 22558 Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar 22585 Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); each additional interspace (List separately in addition to code for primary procedure) 22612 Arthrodesis, posterior or posterolateral technique, single level; lumbar (with or without lateral transverse technique) 22614 Arthrodesis, posterior or posterolateral technique, single level; each additional vertebral segment (List separately in addition to code for primary procedure) 22630 Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar 22632 Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; each additional interspace (List separately in addition to code for primary procedure) 22633 Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and segment; lumbar 22634 Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and segment; each additional interspace and segment (List separately in addition to code for primary procedure) 22800 Arthrodesis, posterior, for spinal deformity, with or without cast; up to 6 vertebral segments 22802 Arthrodesis, posterior, for spinal deformity, with or without cast; 7 to 12 vertebral segments 22804 Arthrodesis, posterior, for spinal deformity, with or without cast; 13 or more vertebral segments 22808 Arthrodesis, anterior, for spinal deformity, with or without cast; 2 to 3 vertebral segments 22810 Arthrodesis, anterior, for spinal deformity, with or without cast; 4 to 7 vertebral segments 22812 Arthrodesis, anterior, for spinal deformity, with or without cast; 8 or more vertebral segments 22840 Posterior non-segmental instrumentation (e.g., Harrington rod technique, pedicle fixation across one interspace, atlantoaxial transarticular screw fixation, sublaminar wiring at C1, facet screw fixation) 22841 Internal spinal fixation by wiring of spinous processes (List separately in addition to code for primary - procedure) 22842 Posterior segmental instrumentation (e.g., pedicle screw fixation, dual rods with multiple hooks and sublaminar wires); 3 to 6 vertebral segments 22843 Posterior segmental instrumentation (e.g., pedicle fixation, dual rods with multiple hooks and sublaminar wires); 7 to 12 vertebral segments 22844 Posterior segmental instrumentation (e.g., pedicle fixation, dual rods with multiple hooks and sublaminar wires); 13 or more vertebral segments 22853 Insertion of interbody biomechanical device(s) (eg, synthetic cage, mesh) with integral anterior instrumentation for device anchoring (eg, screws, flanges), when performed, to intervertebral disc space in conjunction with interbody arthrodesis, each interspace (List separately in addition to code for primary procedure) 22854 Insertion of intervertebral biomechanical device(s) (eg, synthetic cage, mesh) with integral anterior instrumentation for device anchoring (eg, screws, flanges), when performed, to vertebral corpectomy(ies) (vertebral body resection, partial or complete) defect, in conjunction with interbody arthrodesis, each contiguous defect (List separately in addition to code for primary procedure) 22899 Unlisted procedure, spine, when used to describe a service listed under Indications that are not covered on this policy

The following ICD-10-CM Codes do not require prior authorization: Codes Description A17.81 Tuberculoma of brain and spinal cord A18.01 Tuberculosis of spine B90.2 Sequelae of tuberculosis of bones and joints C41.2 Malignant neoplasm of C70.1 Malignant neoplasm of spinal meninges C79.31, Secondary malignant neoplasm of brain and cerebral meninges C79.32 C79.40, Secondary malignant neoplasm of other and unspecified parts of nervous system C79.49 C79.51, Secondary malignant neoplasm of bone and bone marrow C79.52 D33.4 Benign neoplasm of spinal cord D32.1 Benign neoplasm of spinal meninges D43.0-D43.2, Neoplasm of uncertain behavior of brain and central nervous system D43.4 D42.0-D42.9 Neoplasm of uncertain behavior of meninges D48.0 Neoplasm of uncertain behavior of bone and articular cartilage G83.4 Cauda equina syndrome G83.9 Paralytic syndrome, unspecified M08.08, M45.0- Rheumatoid arthritis/ankylosing spondylitis M45.9, M48.8X1- M48.8X9 M24.80 Other specific joint derangements of unspecified joint, not elsewhere classified M25.28 Flail joint, other site M53.2X1- Spinal instabilities M53.2X9 M51.9 Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder M51.06 Intervertebral disc disorders with myelopathy, lumbar region M43.27, Fusion of spine, lumbosacral & sacrococcygeal regions M43.28 M46.2 -M46.28 Osteomyelitis of vertebrae M46.41- Discitis, unspecified M46.45 M53.2X7, Spinal instabilities, lumbar, sacral & sacrococcygeal regions M53.2X8 M53.3 Sacrococcygeal disorders, not elsewhere classified M53.86- Other specified dorsopathies, lumbar, lumbosacral, sacral & sacrococcygeal regions M53.88 M48.50XA- Pathologic fracture of vertebrae M48.58XS, M80.08XA- M80.08XS, M80.88XA- M80.88XS, M84.58XA- M84.58XS M80.00XP, Malunion of fracture M80.08XP, M80.80XP, M80.88XP, M84.30XP, M84.40XP, M84.48XP, M84.50XP, M84.58XP, M84.60XP, M84.68XP M80.00XK, Nonunion of fracture M80.08XK, M80.80XK, M80.88XK, M84.30XK, M84.40XK, M84.48XK, M84.50XK, M84.58XK, M84.60XK, M84.68XK M40.00- Postural kyphosis M40.05 M41.00- Kyphoscoliosis and scoliosis M41.35, M96.5 M96.0 Pseudarthrosis after fusion or arthrodesis S12.000A- Fracture of vertebral column without mention of spinal cord injury S12.691B, S12.9XXA- S12.9XXD, S22.000A- S22.089B, S32.000A- S32.059B, S32.10XA- S32.19XB, S32.2XXA- S32.2XXB S32.009A, Closed fracture of lumbar spine with spinal cord injury S32.019A, S32.029A, S32.039A, S32.049A, S32.059A, S34.101A- S34.129S S32.009B, Open fracture of lumbar spine with spinal cord injury S32.019B, S32.029B, S32.039B, S32.049B, S32.059B, S34.101A- S34.129S S33.101A - Open dislocation, lumbar 33.101S

The following ICD-10-CM Diagnoses codes do require prior authorization. This list is not all inclusive. Codes Description M47.20, Spondylosis of unspecified site without mention of myelopathy M47.819, M47.899, M47.9 M51.26, Other intervertebral disc displacement, lumbar & lumbosacral regions M51.27 M51.36, Other intervertebral disc degeneration, lumbar & lumbosacral regions M51.37 M96.1 Postlaminectomy syndrome, not elsewhere classified M48.061, Spinal stenosis of lumbar region M48.062, M48.07, M99.23, M99.33, M99.43, M99.53, M99.63, M99.73 M54.5 Low back pain (lumbago) M41.80, Other forms of scoliosis, lumbar, lumbosacral regions M41.86, M41.87, M41.9 M43.8X9 Other specified deforming dorsopathies, site unspecified M40.10- Other secondary kyphosis M40.15 M40.50- Lordosis, unspecified M40.57 M41.40- Neuromuscular scoliosis & Other secondary scoliosis M41.57 M43.00- Spondylosis and spondylolisthesis M43.19 Q76.2 Congenital spondylolisthesis Q76.411- Other congenital malformations of spine, not associated with scoliosis Q76.419, Q76.49 S33.100A - Closed dislocation, lumbar vertebra S33.100S S33.141S

Diagnosis Codes that are not associated with the scope of this policy & do not require prior authorization, include but is not limited to: Codes Description M41. 82- Other forms of scoliosis, cervical, cervicothoracic, thoracic, thoracolumbar M41.85 M47.21- Cervical spondylosis without myelopathy M47.23, M47.811- M47.813, M47.891- M47.893 M47.011- Cervical spondylosis with myelopathy M47.029, M47.11- M47.13 M47.24, Thoracic spondylosis without myelopathy M47.25, M47.814, M47.815, M47.894, M47.895 M47.14, Thoracic spondylosis with myelopathy M47.15 M50.20- Other cervical disc displacement M50.23 M51.24, Other intervertebral disc displacement, thoracic & thoracolumbar regions M51.25 M50.30- Other cervical disc degeneration M50.33 M51.34, Other intervertebral disc degeneration, thoracic & thoracolumbar regions M51.35 M50.00- Cervical disc disorder with myelopathy M50.03 M51.04, Intervertebral disc disorders with myelopathy, thoracic & thoracolumbar regions M51.05 M99.12, Subluxation and dislocation of thoracic vertebra S23.100A- S23.171S S23.101A- Dislocation of unspecified thoracic vertebra, initial encounter S23.101S S14.0XXA- Cervical spinal cord injury without evidence of spinal bone injury S14.108S, S14.111A- S14.118S, S14.121A- S14.128S, S14.131A- S14.138S, S14.141A- S14.148S, S14.151A- S14.158S S24.0XXA- Thoracic spinal cord injury without evidence of spinal bone injury S24.104S, S24.111A- S24.114S, S24.131A- S24.134S, S24.141A- S24.144S, S24.151A- S24.154S CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

Approved Medical Director Committee 9/9/08, 9/25/09; Revised 10/15/08, 9/25/09; 5/5/11, 8/18/11, 10/20/11, 12/20/11, 4/18/12, 10/06/17; 7/25/19, 9/15/2021 Annual Review 9/25/09, 9/1/10, 5/2011, 8/2011, 10/2011, 12/2011, 4/2012, 4/2013, 4/2014, 4/2015, 4/2016, 4/2017, 4/2018, 4/2019, 4/2020, 4/2021

References

1. Acosta, F. L., Liu, J., Slimack, N., Moller, D., Fessler, R., & Koski, T. (2011). Changes in coronal and sagittal plane alignment following minimally invasive direct lateral interbody fusion for the treatment of degenerative lumbar disease in adults: a radiographic study. Journal of Neurosurgery: Spine, 15(1), 92-96. doi:10.3171/2011.3.spine10425 2. Chou R, Qaseem A, Snow V, Casey D, Cross JT, Shekelle P, et al. Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147:478-491. doi: 10.7326/0003-4819-147-7-200710020-00006 3. Chou, R. Subacute and chronic low back pain: Surgical treatment. In: UpToDate, Atlas, SJ (Ed), UpToDate, Waltham, MA. (Accessed onJuly 2, 2021) 4. Eck JC, Sharan A, Ghogawala Z, Resnick DK, Watters WC 3rd, Mummaneni PV, Dailey AT, Choudhri TF, Groff MW, Wang JC, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 7: lumbar fusion for intractable low-back pain without stenosis or spondylolisthesis. JNeurosurg Spine. 2014 Jul;21(1):42-7. 5. ECRI Institute. (2013). Hotline Response: Best Practices for Performing Lumbar Spinal Fusion. Plymouth Meeting, PA: ECRI Institute. 6. ECRI Institute. Spinal fusion and discography for chronic low back pain and uncomplicated lumbar degenerative disc disease (Washington HTA). Plymouth Meeting (PA): ECRI Institute Health Technology Assessment Information Service; 2007 October 19. (Evidence Report). Available at URL address: http://www.ecri.org. 7. .ECRI Institute. (2018). AxiaLIF Plus (TranS1, Inc.) for Axial Lumbar Interbody Fusion. Plymouth Meeting, PA: ECRI Institute. 8. Falowski, S. M., Mangal, V., Pope, J., Patel, A., Coleman, M., Kendall, D., ... & Fishman, M. A. (2021). Multicenter Retrospective Review of Safety and Efficacy of a Novel Minimally Invasive Lumbar Interspinous Fusion Device. Journal of Pain Research, 14, 1525. 9. Guyer, R., Patterson, M., Ohnmeiss, D., 2006, Failed Back Surgery Syndrome: Diagnostic Evaluation, Journal of the American Academy of Orthopaedic Surgeons, Volume 14, pg 534-543. 10. Hayes, Inc. Hayes Health Technology Brief. AxiaLIF (Axial Lumbar Interbody Fusion) System (TranS1 Inc.) for Percutaneous Lumbosacral Surgery. Lansdale, PA: Hayes, Inc.; June, 2012, Reviewed June 2014. Archived July 2015. 11. Hayes, Inc. Hayes Health Technology Brief. Dynesys® Dynamic Stabilization System (Zimmer Inc.) for Degenerative Spondylolisthesis. Lansdale, PA: Hayes, Inc.; December, 2007. Reviewed December 2009. Archived January, 2011. 12. Hayes, Inc. Hayes Health Technology Brief. eXtreme Lateral Interbody Fusion (XLIF; NuVasive Inc.) for Treatment of Chronic Low Back Pain. Lansdale, PA: Hayes, Inc.; November, 2012. Reviewed October, 2014, Archived December, 2015. 13. Hayes, Inc. Hayes Health Technology Brief. Extreme Lateral Interbody Fusion (XLIF;NuVasive Inc.) for Treatment of Degenerative Spinal Disorders. Lansdale, PA: Hayes, Inc.; June, 2017, reviewed July 2019 , Archived July 2020 14. Hayes, Inc. Hayes Medical Technology Directory Report. Laparoscopic Anterior Lumbar Interbody Fusion for Treatment of Low Back Pain. Lansdale, PA: Hayes, Inc.; June, 2002. Reviewed June, 2007.Archived January, 2008. 15. Hayes, Inc. Hayes Medical Technology Directory Report. Minimally Invasive Transforaminal Lumbar Interbody Fusion (MITLIF) Versus Open Transforaminal Lumbar Interbody Fusion (OTLIF) for Treatment of Lumbar Disc Disease: A Review of Reviews. Lansdale, PA: Hayes, Inc.; September, 2016, Reviewed January 2021 16. Hayes, Inc. Hayes Medical Technology Directory Report. Recombinant Human Bone Morphogenetic Protein rhBMP( ) for Use in Spinal Fusion. Lansdale, PA: Hayes, Inc.; April, 2014. Reviewed March, 2017. 17. Hayes, Inc. Hayes Medical Technology Directory Report. Comparative Effectiveness Review of Recombinant Human Bone Morphogenetic Protein (rhBMP) for Use in Spinal Fusion. Lansdale, PA: Hayes, Inc.; September, 2018, Reviewed January 2021 18. International Society for the Advancement of Spine Surgery (ISASS), Policy Statement on Lumbar Spinal Fusion Surgery (2011). Accessed May, 2017. 19. Johnson, RG. (2014). Bone marrow concentrate with allograft equivalent to autograft in lumbar fusions. Spine, 39(9), 695- 700. 20. Levin, K., : Treatment and prognosis. In: UpToDate, Aminoff, M., Atlas, S. (Ed), UpToDate, Waltham, MA. (Accessed onJuly 27, 2021) 21. Lopez, A. J., Scheer, J. K., Dahdaleh, N. S., Patel, A. A., & Smith, Z. A. (2017). Lumbar Spinous Process Fixation and Fusion. Clinical spine surgery, 30(9), E1279-E1288 22. Mobbs RJ, Phan K, Malham G, Seex K, Rao PJ. Lumbar interbody fusion: techniques, indications and comparison of interbody fusion options including PLIF, TLIF, MI-TLIF, OLIF/ATP, LLIF and ALIF. J Spine Surg 2015;1(1):2-18.doi : 10.3978/j.issn.2414-469X.2015.10.05 23. North American Spine Society (NASS). Clinical Guidelines for diagnosis and treatment of lumbar disc herniation with radiculopathy. (2012). 24. North American Spine Society (NASS) - Degenerative Lumbar Spondylolisthesis, Appropriate Use Criteria, 2020 25. North American Spine Society (NASS). Diagnosis and treatment of adult isthmic spondylolisthesis. (2014). 26. Nwosu, K, Hershman, S., Cha, T. (2018) Shared decision-making in spine surgery , Seminars in Spine Surgery, Vol. 30, 99- 103 27. Panchal, R., Denhaese, R., Hill, C., Strenge, K., De Moura, A., Passias, P. …..Kim, K. (2018), Anterior and Lateral Lumbar Interbody Fusion With Supplemental Interspinous Process Fixation: Outcomes from a Multicenter, Prospective, Randomized, Controlled Study, International Journal of Spine Surgery, 2018 Apr 12 (2) 28. Schroeder GD, Kepler CK, Mba MD, Vaccaro AR. Axial interbody arthrodesis of the L5-S1 segment: A systematic review of the literature. J Neurosurg Spine. 2015;23(3):314-319. 29. Sembrano, J. N., Tohmeh, A., Isaacs, R., & SOLAS Degenerative Study Group. (2016). Two-year comparative outcomes of MIS lateral and MIS transforaminal interbody fusion in the treatment of degenerative spondylolisthesis: part I: clinical findings. Spine, 41, S123-S132 30. Simpson, A. K., Lightsey IV, H. M., Xiong, G. X., Crawford, A. M., Minamide, A., & Schoenfeld, A. J. (2021). Spinal endoscopy: Evidence, techniques, global trends, and future projections. The Spine Journal. 31. Washington State Health Care Authority. Health technology Assessment. Lumbar Fusion for patients with degenerative disc disease- re –review. October 16, 2015. Accessed October 31, 2016. 32. Woods, K. R., Billys, J. B., & Hynes, R. A. (2017). Technical description of oblique lateral interbody fusion at L1–L5 (OLIF25) and at L5–S1 (OLIF51) and evaluation of complication and fusion rates. The Spine Journal, 17(4), 545-553.