Bone Grafts and Stabilization Devices for Spinal Defects Form

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Bone Grafts and Stabilization Devices for Spinal Defects - Medical Policy
Updated Revision Effective: October 1, 2025 Policy Number:

UM429POL

Approval Date: 8/5/2025

Line(s) of Business:

Commercial
Medicare Advantage
Medicaid (BeHealthy)

Description

After spinal reconstruction and fusion procedures, solid bone healing is desired to reduce pain and improve function and quality of life. However, solid bone healing may not always occur. Bone grafting is one of the most common procedures to augment bone healing. More than 2 million bone grafting procedures are performed annually worldwide. Autologous bone is considered the gold standard since it possesses all of the properties needed for bone regeneration (i.e., osteoconduction, osteoinduction, and osteogenesis) (Wang et al., 2017). Bone grafts can also be obtained from bone banks (cadaver allograft) or composed of synthetic material (Wang et al., 2017).

Bone morphogenetic proteins (BMPs) are members of the family of transforming growth factors. At present, some 20 different BMPs have been identified, all with varying degrees of tissue-stimulating properties.
Recombinant human bone morphogenetic proteins (rhBMPs) are delivered to the bone grafting site as part of a surgical procedure; a variety of carrier and delivery systems have been investigated. Carrier systems, which are absorbed over time, function to maintain the concentration of the rhBMP at the treatment site; provide temporary scaffolding for osteogenesis; and prevent extraneous bone formation. Carrier systems have included inorganic material, synthetic polymers, natural polymers, and bone allograft.

The rhBMP and carrier may be inserted via a delivery system, which may also function to provide mechanical support. The carrier and delivery systems are important variables in the clinical use of rhBMPs, and different clinical applications, such as long-bone nonunion, or interbody or intertransverse fusion, have been evaluated with different carriers and delivery systems. For example, rhBMP putty with pedicle and screw devices are used for instrumented intertransverse fusion (posterolateral fusion; PLF), while rhBMP in a collagen sponge with bone dowels or interbody cages are used for interbody spinal fusion. In addition, interbody fusion of the lumbar spine can be approached from an anterior (anterior lumbar interbody fusion; ALIF), lateral (XLIF), or posterior direction (PLIF or TLIF). Surgical procedures may include decompression of the spinal canal and insertion of pedicle screws and rods to increase stability of the spine. Posterior approaches (PLIF and TLIF) allow decompression (via laminotomies and facetectomies) for treatment of spinal canal pathology (e.g., spinal stenosis, lateral recess and foraminal stenosis, synovial cysts, hypertrophic ligamentum flavum) along with stabilization of the spine and are differentiated from instrumented or noninstrumented posterolateral intertransverse fusion (PLF), which involves the transverse processes. Due to the proximity of these procedures to the spinal canal, risks associated with ectopic bone formation are increased (e.g., radiculopathies). Increased risk of bone resorption around rhBMP grafts, heterotopic bone formation, epidural cyst formation, and seromas have also been postulated.

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 Line of Business

Commercial:

• Refer to criteria under the Policy section in this medical policy.

Medicaid – BeHealthy:

• Refer to criteria under the Policy section in this medical policy.

Medicare:

• Refer to criteria under the Policy section in this medical policy.

Policy

I. HNE considers Spinal Bone Grafting (cadaveric allograft, demineralized bone allograft) MEDICALLY NECESSARY for spinal fusions.

II. Spinal Bone Grafting with recombinant human bone morphogenic protein 2 (rhBMP 2, InFUSE) is considered MEDICALLY NECESSARY for 18 years old or more individuals undergoing spinal fusions when ALL of the following are met:

A. Single level degenerative disc disease from the fourth lumbar vertebra (L4) to the first sacral vertebra (S1) leading to discogenic back pain; AND

B. Member does not have greater than grade I Spondylolisthesis (25% displacement) at the involved level; AND

C. The approach is anterior or oblique and used in conjunction with an FDA-approved interbody fusion device; AND

D. Member is not known or suspected to have malignancy and is not known or suspected to have an active infection at operative site.

III. Recombinant human bone morphogenic protein 2 (rhBMP 2, InFUSE) is considered EXPERIMENTAL AND INVESTIGATIONAL for ALL other spinal bone grafting indications or approaches other than those listed above, or when used for non-FDA approved indications (i.e., “off label”).

IV. The following bone graft substitutes for the enhancement of bone healing are considered EXPERIMENTAL, INVESTIGATIONAL OR UNPROVEN (this is not an all-inclusive list):

A. rhBMP-7. B. INFUSE/MASTERGRAFT Posterolateral Revision Device. C. Human amniotic membrane bone graft substitute. D. Cell-based substitutes other than bone marrow aspirate for enhancing of bone healing E. Ceramic-based products. F. Human growth factors substitute (e.g., fibroblast growth factor, insulin-like growth factor) for enhancing bone healing.
G. Platelet-rich plasma for enhancing bone healing.

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H. OptiMesh deployable grafting system. I. Bone graft substitutes when used to reduce donor site morbidity (e.g., iliac crest donor site reconstruction).
J. Allograft bone graft substitutes that are used only as stand-alone stabilization devices for fusion. K. i-FACTOR Bone Graft for single level anterior cervical discectomy and fusion. L. Mesenchymal stem cell therapy (e.g., AlloStem, Osteocel, Osteocel Plus, Ovation, Regenexx, and Trinity Evolution) and/or the use of progenitor cells for spinal fusions.

Policy Guidelines and Definitions

Policy Guidelines:

I. Required Documentation

A. Clinical notes from treating provider referencing above criteria

B. CPT codes and disc level for planned surgery

C. Relevant radiograph imaging

II. List of FDA -APPROVED INFUSE Bone Graft Devices:

A. INFUSE™ Bone Graft/Medtronic Interbody Fusion Device

B. Divergence-L Anterior/Oblique Lumbar Fusion System

C. Pivox™ Oblique Lateral Spinal System

D. Perimeter Interbody Fusion Device implanted via retroperitoneal ALIF L2 to S1 or OLIF L5 to S1

E. Clydesdale Spinal System implanted via OLIF at single level from L2-S5

F. INFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device

G. Anterior open or anterior laparoscopic approach

H. Infuse™ Bone Graft/Inter Fix™ Threaded Fusion Device

I. Infuse™ Bone Graft/Inter Fix™ RP Threaded Fusion Device

III. Interlaminar Stabilization Devices (22867, 22868) due to a low quality evidence are considered EXPERIMENTAL and INVESTIGATIONAL, including but not limited to:

• Coflex Interlaminar Stabilization Device • Dynesys Stabilization System • LimiFlex Dynamic Sagittal Tether
• Zimmer DTO Implant • BioFlex,
• CD Horizon Agile Dynamic Stabilization Device,
• DSS Dynamic Soft Stabilization System,
• Dynabolt Dynamic Stabilization System,

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• Graf ligamentoplasty/Graf artificial ligament,
• Isobar Spinal System,
• NFix, • Satellite Spinal System,
• Stabilimax NZ Dynamic Spine Stabilization System, • Zodiak DynaMo System.

IV. Interspinous Process Spacer, i.e. Superion Interspinous Spacer, (22869, 22870) due to a low quality evidence is considered EXPERIMENTAL and INVESTIGATIONAL.

Definitions:

Autograft is considered a Gold standard for bone grafting and is taken from the individual. The usual site for an autograft harvest is the posterior iliac crest. When autograft material is of insufficient volume, of poor quality or cannot be used for any other reason, another type of material must be used for the bone graft. NOTE: Blood products (including platelets) and bone marrow aspirate (including mesenchymal stem cells) are NOT considered autograft materials.

Allograft is obtained from cadaveric bone and/or tissue from a bone bank and may be used alone or in combination with another material. Even when used alone, allograft must be processed to decrease the likelihood of disease transmission and immunogenic response. An example of allograft bone product is Cornerstone. NOTE:
Amniotic membrane/placental membrane, blood products (including platelets) and bone marrow aspirate (including mesenchymal stem cells) are NOT considered allograft materials.

Demineralized Bone Matrix (DBM) is a type of allograft that is produced by acid extraction of allograft bone (known as decalcification). Based on manufacturing techniques, DBM may be a freeze-dried powder, granules, gel, putty or strips.

Ceramic/Bone Fillers are synthetically produced bone void fillers. As a conductive technology, ceramics are synthetic materials resulting from heating up chemically formed compounds that consequently bond together.
There are many different methods to produce ceramics and numerous chemical compounds that can be combined, including calcium phosphate, calcium sulfate-calcium composite, beta tricalcium phosphate or nanocrystalline hydroxyapatite.

Combination Bone Graft Substitutes: A newer practice in bone graft substitutes is the combination of different materials to produce a completely different product, with the theory that each different property working together will aid in the healing and grafting process. Example: Grafton is a DBM product commonly used with autograft as a bone graft extender. It is a soft non-structural product often used in conjunction with instrumentation.

Interspinous Process Spacer: Device is proposed to create space between the spinous processes and limit extension, thereby enlarging the neural foramen to reduce symptoms of neural claudication.

Interlaminar spinal stabilization device (i.e., Coflex): Device is proposed to provide benefits over fusion (i.e., durable pain relief, maintenance of spinal motion, decreased hypermobility).

Discogenic back pain is caused by intervertebral disc that is externally intact versus disc herniation or prolapse that causes pressure on nearby nerve roots. Discogenic back pain does not radiate down legs and is confined to the back.

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Spondylolisthesis is slipping of vertebra forward over another vertebrae. Generally, symptoms consist of back and/or leg pain. Cause is most likely from underlying conditions of spondylolysis. Types of spondylolisthesis include degenerative, isthmic, dysplastic, pathogenic or traumatic.

Spondylolysis is a defect or stress fracture in the vertebral arch often occurring in lower lumbar vertebrae (L5) but may occur in cervical region also.

Infuse Bone Graft is a recombinant human bone morphogenetic protein-2 (rhBMP-2) that is applied to an absorbable collagen sponge carrier (ACS). This protein is used to stimulate natural bone formation. This type of bone graft has high osteoinductivity.

Coding Guidance

CPT Codes
Description
PA/No PA E&I 20930 Allograft, morselized, or placement of osteopromotive material, for spine surgery only. PA Commercial Only*

20931 Allograft, structural, for spine surgery only. PA

20936 Autograft for spine surgery only (includes harvesting the graft); local (e.g., ribs, spinous process, or laminar fragments) obtained from same incision. NO PA

20937 Autograft for spine surgery only (includes harvesting the graft); morselized (through separate skin or fascial incision). NO PA

20938 Structural, bicortical or tricortical (through separate skin or fascial incision).
NO PA

20939 Bone marrow aspiration for bone grafting, spine surgery only, through separate skin or fascial incision (List separately in addition to code for primary procedure). NO PA

22853 Insertion of interbody biomechanical device(s) (e.g., synthetic cage, mesh) with integral anterior instrumentation for device anchoring (e.g., screws, flanges), when performed , to intervertebral disc space in conjunction with interbody arthrodesis, each interspace (List separately in addition to code for primary procedure).
NO PA

22867
Insertion of interlaminar/interspinous process stabilization device, without fusion, including image guidance when performed, with open decompression, lumbar; single level.
NO PA E&I 22868 Insertion of interlaminar/interspinous process stabilization device, without fusion, including image guidance when performed, with open decompression, lumbar second level. NO PA E&I 22869 Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level NO PA E&I

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CPT Codes
Description
PA/No PA E&I 22870 Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level (List separately in addition to code for primary procedure) NO PA E&I L8699 Prosthetic implant, not otherwise specified NO PA Not covered if used for any bone graft substitute product.

*20930 is not payable for MassHealth or Medicare

CPT® Copyright 2025 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

Bone grafts and biomaterials substitutes for bone defect repair: A review. Published online 2017 Jun 7. doi:

10.1016/j.bioactmat.2017.05.007

Bone grafts and biomaterials substitutes for bone defect repair: A review - PMC (nih.gov)

Muchow RD, Hsu WK, Anderson PA. Histopathologic inflammatory response induced by recombinant bone morphogenetic protein-2 causing radiculopathy after transforaminal lumbar interbody fusion. Spine J 2010 Sep; 10(9): e 1-6

https://www.thespinejournalonline.com/article/S1529-9430(10)00495-X/fulltext

Hayes Medical Technology Site: Coflex Interlaminar Stabilization Device (Surgalign Spine Technologies Inc.) for Treatment of Lumbar Spinal Stenosis

https://evidence.hayesinc.com/report/htb.coflex2708

Simmonds, M. C., Brown, J. V. E., Heirs, M. K., Higgins, J. P. T., Mannion, R. J., Rodgers, M. A., & Stewart, L. A. (2013, June 18). Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data.

https://annals.org/aim/fullarticle/1696645/safety-effectiveness-recombinant-human-bone-morphogenetic- protein-2-spinal-fusion

Fu, R., Selph, S., McDonagh, M., Peterson, K., Tiwari, A., Chou, R., & Helfand, M. (2013, June 18). Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta- analysis.

https://www.ncbi.nlm.nih.gov/pubmed/23778906

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Infuse Bone Graft - Alternatives, Controversy & Complications. (2020, February 27)

https://www.drugwatch.com/infuse/

Park, D, Jenis, L, Bone Grafts in Spine Surgery (Last reviewed October 2021) https://orthoinfo.aaos.org/en/treatment/bone-grafts-in-spine-surgery/

Anderson MD, D. G., The Role of Bone Graft in Spinal Surgery (Updated 9/10/2019)

https://www.spineuniverse.com/treatments/surgery/role-bone-graft-spinal-fusion-surgery

Corenman MD, D, Bone Graft Types for Spinal Fusion Surgery, (Updated 5/15/2019) Retrieved March 1, 2022, from

https://www.spineuniverse.com/treatments/surgery/bone-graft-types-spinal-fusion-surgery

Infuse Bone Graft | Medtronic

Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 11/12/2013 Initial Policy Date. 08/2023 New template, criteria re-written. Added criteria and codes for interlaminar/interspinous process stabilization/distraction device, no change to coverage. 10/2023 Removed PA from 20930 for MassHealth and Medicare (non-payable codes). 1/2024 Line of Business section added. 06/2025 Minor Criteria Changes. Experimental and Investigational bone graft substitutes list reviewed and updated. Experimental and Investigational Interlaminar Stabilization Devices list reviewed and updated.

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this

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service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.