ModifiedUnitedHealthcarePolicy CS009KS.02

Spinal Fusion and Bone Healing Enhancement Products (for Kansas Only)

Defines medical necessity and not-medically-necessary determinations for autografts, allografts, DBM, rhBMP-2 (InFUSE) and other bone graft substitutes for spinal fusion in members covered in Kansas.

Policy Summary

PayerUnitedHealthcare

PolicySpinal Fusion and Bone Healing Enhancement Products (for Kansas Only)

Policy CodePolicy CS009KS.02

Change TypeMaterial: clarified ceramic-based products as unprovenadditional definitional and documentation updates

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionObtain and make available complete medical records documenting history, exam, imaging and fusion assessment when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added language to clarify Ceramic-Based Products used alone or in combination with other grafts and/or graft components, including Bone Marrow Aspirate (BMA), are unproven and not medically necessary.

Added language describing required medical records documentation to assess clinical criteria for coverage and that documentation does not guarantee coverage.

Added definitions for Osseointegration, Osteoconduction, and Osteoinduction.

Updated definitions of Allograft, Autograft, and Bone Marrow Aspiration.

Updated Clinical Evidence, FDA, and References sections to reflect most current information.

Kansas-onlyjurisdiction

L2-S1InFUSE indication

single level

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unprovenceramic graft stance

Coverage Criteria for Spinal Fusion and Osteobiologics

Covered indications / medically necessary

Proven and medically necessary products for spinal fusion when criteria are met

Autografts (including Bone Marrow Aspirate used for bone grafting) are considered proven and medically necessary.

Demineralized Bone Matrix (DBM) is considered proven and medically necessary when not combined with products listed as unproven and not medically necessary.

Allograft-based products are considered proven and medically necessary unless specifically listed as unproven and not medically necessary.

InFUSE Bone Graft (rhBMP-2) — lumbar: InFUSE Bone Graft (recombinant human BMP-2) is medically necessary for lumbar spine fusion when ALL of the following are met: the approach is anterior or oblique and used in conjunction with an FDA‑approved interbody fusion device; the patient is skeletally mature (≥18 years or radiographic epiphyseal closure) with degenerative disc disease; fusion involves vertebral bodies L2–S1 with spondylolisthesis no greater than Grade 1 (≤25% displacement) at the involved level; and the fusion is single level.

InFUSE/MASTERGRAFT Posterolateral Revision Device (or InFUSE BMP used with MASTERGRAFT) is medically necessary when used per FDA indications and ALL of the following are met: implanted via a posterolateral approach; presence of symptomatic posterolateral lumbar spine pseudoarthrosis; patient is skeletally mature (>21 years or radiographic epiphyseal closure); and autologous bone and/or bone marrow harvest is not feasible or is not expected to promote fusion.

Must be used according to FDA indications, contraindications, warnings, and precautions.

Not medically necessary / unproven

Products considered unproven and not medically necessary due to insufficient evidence

Cell-based allograft products (e.g., products containing mesenchymal stem cells or other living-cell allografts) are unproven and not medically necessary due to insufficient and very-low-quality evidence regarding safety and efficacy.

Evidence assessments (ECRI, Hayes) report very-low-quality or inconclusive data.

Human amniotic tissue materials, including amniotic fluid stem cell substitutes, are unproven and not medically necessary due to limited human evidence and unestablished long-term safety and efficacy.

Recombinant BMP/InFUSE for non-covered indications: Recombinant human BMP-2 (e.g., InFUSE) and InFUSE/MASTERGRAFT Posterolateral Revision Device are considered unproven and not medically necessary for all indications not specifically listed as medically necessary in this policy.

Off-label uses require strong justification and may be denied.

Ceramic-based products (e.g., beta tricalcium phosphate, calcium phosphate, calcium sulfate) used alone or in combination with other grafts and/or graft components, including Bone Marrow Aspirate (BMA), are unproven and not medically necessary.

Evidence-based coverage considerations

Coverage considerations based on available evidence:

rhBMP-2 for lumbar ALIF (L2–S1): Systematic reviews and randomized trials provide the highest-quality evidence supporting rhBMP-2 (InFUSE) for lumbar interbody fusion (ALIF/OLIF) at levels L2–S1, showing comparable or improved fusion rates versus iliac crest bone graft and advantages of avoiding graft harvest; evidence grade reported as A1 in a recent systematic review.A1 evidence reported for Infuse

Clinical benefit in pain/disability is not consistently demonstrated; long-term risks remain incompletely characterized.

rhBMP-2 for cervical fusion: Systematic reviews and FDA communications indicate higher adverse event rates, including life‑threatening complications, when rhBMP-2 is used for cervical fusion; the risks may outweigh benefits for routine cervical use.FDA off-label concern

Off-label cervical use may trigger denial or require compelling justification and supporting evidence.

Human amniotic tissue:

Coverage considerations

Evidence-based coverage considerations from reviewed literature

Ceramic and bioactive glass substitutes — trial evidence requirements: Use of ceramic substitutes or bioactive glass may be considered when evidence demonstrates fusion rates and patient outcomes comparable to autograft in adequately powered, well‑designed randomized controlled trials with appropriate follow-up (≥2 years) and patient‑oriented outcomes.evidence: adequately powered RCTs with patient-oriented outcomes and >=2 year follow-up

Existing studies include intra-patient RCTs and observational series with limitations (small size, potential imaging bias, short follow-up).

Silicate‑substituted calcium phosphate (SiCaP): SiCaP materials have reported pooled fusion rates around 93% across heterogeneous studies, but high heterogeneity and study limitations restrict definitive conclusions about superiority or broad generalizability.pooled fusion ~93%

Further high‑quality research is required.

Expandable interbody fusion systems — evidence gap:

Society-guided conditional coverage options

Society recommendations and conditional uses summarized (these reflect options rather than absolute coverage mandates):

AANS guidance on DBM and b-TCP: AANS guideline statements note DBM can be used as a bone graft extender for 1‑ and 2‑level instrumented posterolateral fusions, and b‑TCP/local autograft can be an option as a substitute for autologous iliac crest bone (AICB) for single‑level instrumented posterolateral fusion due to comparable fusion rates and outcomes.

Guideline reference: Kaiser et al., 2014.

Hydroxyapatite and calcium extenders: Hydroxyapatite (HA) with local autograft or BMA can be used as a substitute for AICB or as a graft extender; calcium sulfate mixed with local autograft is an option for instrumented posterolateral fusions though evidence for some composites remains insufficient.

rhBMP-2 conditional uses (NASS/AANS summaries): Society guidance indicates rhBMP‑2 may be considered as an adjunct in select scenarios (e.g., ALIF stand‑alone, high risk of nonunion, inadequate autograft) but should not be used routinely for anterior/posterior cervical fusion, single‑level posterolateral fusions in healthy adults, or routine pediatric spine fusions.

These are conditional recommendations and not absolute coverage directives.

Unproven / Not Medically Necessary: Ceramic-Based Products

Not medically necessary statement for specific product types

Ceramic-Based Products NMN: Ceramic‑based products (for example, beta tricalcium phosphate, calcium phosphate, calcium sulfate) used alone or in combination with other grafts and/or graft components, including Bone Marrow Aspirate (BMA), are unproven and not medically necessary.

Clarification added to policy Summary of Changes (12/01/2025).

Specific products and classes listed in the policy's unproven and not medically necessary section are excluded from being considered medically necessary. This list explicitly includes cell-based allografts (e.g., MSC-containing products), human amniotic tissue materials, recombinant human BMP-2/InFUSE for indications not otherwise covered, ceramic-based products (such as beta tricalcium phosphate, calcium phosphate, calcium sulfate) used alone or combined with other grafts or Bone Marrow Aspirate (BMA), bioactive glass, and Expandable Interbody Fusion Systems.

Off-label use of rhBMP-2 (InFUSE) for cervical fusion is associated with increased adverse events and has been the subject of FDA warnings; these reports indicate potential life‑threatening complications (for example, airway or neurologic compression). Because of these safety concerns, rhBMP-2 used for cervical fusion is effectively excluded from routine coverage and will be subject to heightened scrutiny or denial absent compelling justification and supporting documentation.

The policy further clarifies that recombinant BMP-2 products and InFUSE/MASTERGRAFT Posterolateral Revision Device are considered unproven and not medically necessary for indications not specifically listed as medically necessary in the policy.

Expandable interbody fusion systems are considered unproven due to a lack of prospective randomized controlled trials with larger sample sizes and longer-term follow-up demonstrating patient-oriented benefits. The available systematic reviews and meta-analyses of mainly retrospective studies do not show clear clinical advantages over static cages and have important limitations (selection bias, heterogeneity), so such devices may be excluded from coverage or require prior authorization and device-specific justification.

When expandable systems are proposed, documentation should include the specific device, indication, and any FDA clearance/approval information; absent robust evidence of superior patient outcomes, these systems are treated as investigational in this policy.

The policy states that rhBMP-2 should not be used routinely for anterior and posterior cervical fusion procedures. Society guidance summarized in the policy also recommends against routine use of rhBMP-2 for single-level posterior/posterolateral fusions in healthy adults and for routine pediatric spine fusion procedures. Given additional evidence of higher adverse event rates with cervical use, these routine cervical applications are excluded from coverage.

For covered lumbar indications, rhBMP-2 (InFUSE) is limited to the specific FDA-approved lumbar uses noted elsewhere in the policy; any use outside those specified indications is considered unproven and not medically necessary.

Ceramic-based products (examples include beta tricalcium phosphate [b‑TCP], calcium phosphate, and calcium sulfate) when used alone or combined with other grafts or graft components — including Bone Marrow Aspirate (BMA) — are designated as unproven and not medically necessary. The policy's Summary of Changes explicitly added language clarifying that such ceramic-based products used alone or with BMA are excluded from being considered medically necessary.

Cell-based allografts (for example, products containing mesenchymal stem cells), human amniotic tissue materials, certain recombinant BMP uses outside defined indications, and the specified synthetic graft classes (including ceramics and bioactive glass) are considered unproven and not medically necessary because current published clinical literature is insufficient to determine safety and efficacy.

Available evidence assessments (ECRI, systematic reviews) report very-low-quality or inconclusive data for many cell-based and amniotic-tissue products, supporting the policy's not‑medically‑necessary stance for these classes when used for spinal fusion.

Human amniotic tissue products have limited human evidence for efficacy in lumbar fusion and lack established long-term safety data; accordingly these products should be considered unproven and not medically necessary for spinal fusion outside of well‑designed research settings.

Similarly, ceramic-based products without adequate product‑specific clinical evidence (including trials with appropriate comparators and meaningful follow-up) are considered unproven and not medically necessary until higher-quality evidence is available.

Bioactive glass products, a class of synthetic silica‑based materials (e.g., 45S5), are claimed to promote rapid hydroxycarbonate apatite formation and osteoconductivity, but there is insufficient high-quality evidence to determine their efficacy and safety compared with iliac crest bone graft (ICBG). These products are therefore considered investigational or not medically necessary in the absence of robust randomized trials.

Evidence comparing expandable cages to static cages comes primarily from retrospective studies and systematic reviews of low-quality data; pooled analyses show improvements in some radiographic parameters (e.g., anterior disc height, segmental lordosis) but no clear differences in patient-reported pain or disability. Given the low quality of evidence and lack of prospective RCTs demonstrating superior patient outcomes, expandable cages do not currently demonstrate clear clinical benefit over static cages and are treated as unproven for routine coverage decisions.

Examples of ceramic‑based products include beta tricalcium phosphate (b‑TCP), calcium phosphate, and calcium sulfate. The policy explicitly lists these materials and states that when they are used alone or in combination with other grafts and/or graft components (including BMA), they are considered unproven and not medically necessary. This clarification was added to the policy history to emphasize the exclusion.

Procedure Codes and Device Identifiers

Applicable procedure codes (reference)CPT

0814T	Percutaneous injection of calcium-based biodegradable osteoconductive material, proximal femur, including imaging guidance, unilateral.
20930	Allograft, morselized, or placement of osteopromotive material, for spine surgery only (List separately in addition to code for primary procedure).
20931	Allograft, structural, for spine surgery only (List separately in addition to code for primary procedure).
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).
22899	Unlisted procedure, spine

Not explicit CPT/HCPCS codes in this segment — product identifiersmixed

Infuse™ (rhBMP-2)

Product name — FDA-approved spinal fusion product containing rhBMP-2 (Absorbable collagen sponge coated in rhBMP-2) for L2–S1

FDA-cleared/approved devices referencedmixed

Duo (K210155 / 510(k))	Duo™ Expandable Interbody Fusion System — 510(k) for L2–L5 one- or two-level lumbar intervertebral body fusion
OptiMesh (K014200 / 510(k) and DEN200010 De Novo)	OptiMesh® Expandable Interbody Fusion System — 510(k) and later De Novo for expanded indications
i-FACTOR (PMA id=320591 / 510(k) noted)	i-FACTOR® peptide enhanced bone graft — referenced FDA action
InFUSE (PMA id=P000058 / HDE/Mastergraft referenced)	InFUSE™ Bone Graft / LT-CAGE™ — PMA and HDE references

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Advised for Off‑Label or Higher‑Risk Osteobiologics

Prior authorization may be required for off‑label or higher‑risk uses of osteobiologics (for example, rhBMP‑2 in cervical fusion, novel or experimental biologic products, or expandable systems). When seeking prior authorization for these uses, submit supporting clinical evidence that justifies the off‑label indication and documents why standard grafting options (including autograft) are not appropriate or feasible.

Submit relevant peer‑reviewed literature, prior surgical reports, and risk/benefit rationale.
If the request is for rhBMP‑2 in the cervical spine, note FDA warnings regarding life‑threatening adverse events (e.g., airway or neurologic compression). Off‑label cervical use may be denied based on safety concerns.

Prior Authorization

Prior Authorization: Device and Indication Documentation

When requesting prior authorization for a device or osteobiologic, clearly identify the specific product (model/name/manufacturer) and the intended anatomic indication, and state the product's FDA clearance/approval status. Provide the operative plan, the implant approach, and whether use aligns with FDA‑cleared indications.

Background and Clinical Context

Autologous iliac crest bone graft (ICBG) is the historical gold standard for spinal fusion because it provides osteoconductive, osteoinductive, and osteogenic properties that support bone formation. Although ICBG is associated with donor‑site morbidity, it remains the benchmark against which substitutes and extenders are compared in clinical trials and evidence assessments.

Definitions and Terminology

Allograft — Transplant of tissue from one individual to another of same species

DefinitionTransplant of tissue from one individual to another of the same species with a different genotype (allogeneic graft or homograft).

SynonymsAllogeneic graft; homograft.

Policy contextConsidered a proven graft option for spinal fusion unless specifically listed as unproven/not medically necessary.

Autograft — Tissue grafted into a new position in the body of the same individual

DefinitionTissue grafted into a new position in the body of the same individual.

Common useAutograft (e.g., iliac crest bone graft) is the historical gold standard for spinal fusion due to osteoconductive, osteoinductive and osteogenic properties.

Policy Revision History

2025-12-01policy_revisionLatest

Added coverage rationale clarifying that Ceramic‑Based Products (e.g., b‑TCP, calcium phosphate, calcium sulfate) used alone or in combination with other grafts or graft components, including Bone Marrow Aspirate (BMA), are unproven and not medically necessary; updated medical records documentation requirements and added definitions (Osseointegration, Osteoconduction, Osteoinduction); updated Clinical Evidence, FDA, and References sections.

Policy Summary

PayerUnitedHealthcare

PolicySpinal Fusion and Bone Healing Enhancement Products (for Kansas Only)

Policy CodePolicy CS009KS.02

Change TypeMaterial: clarified ceramic-based products as unprovenadditional definitional and documentation updates

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionObtain and make available complete medical records documenting history, exam, imaging and fusion assessment when requesting prior authorization.

SourceLink

On This Page

Bioactive glass products used alone or in combination with other grafts (including BMA) are unproven and not medically necessary due to insufficient high-quality comparative evidence.

Expandable interbody fusion systems are unproven and not medically necessary due to lack of prospective randomized controlled trials with adequate size and follow-up demonstrating patient‑oriented benefit.

Available human evidence for amniotic tissue in lumbar fusion is limited and long-term safety/efficacy are not established; use should be considered investigational pending further research.

insufficient evidence

Ceramic-based products and heterogeneity of evidence: Evidence for ceramic-based products is heterogeneous; while some product-specific trials report noninferiority or favorable fusion rates, concerns about generalizability, study design (intra-patient models), imaging assessment methods, and limited follow-up preclude broad coverage without robust, product-specific data from adequately powered RCTs with patient‑oriented outcomes.product-dependent

Further large, long-term, multi-center RCTs are needed.

Expandable interbody fusion systems are considered unproven because of very low‑quality evidence and a lack of prospective RCTs reporting patient‑oriented outcomes; use may require prior authorization or be considered investigational.

lack of RCTs with patient-oriented outcomes

Product‑specific titanium implants and patient‑specific implants have very low‑quality evidence.

Document device model/name and manufacturer.

State FDA status (e.g., 510(k), PMA, De Novo, HDE) and cite the relevant FDA summary or clearance number if available.

Describe the surgical approach (anterior/oblique/posterolateral) and the planned use (e.g., interbody with an FDA‑approved interbody fusion device).

Denial Risk

Off‑Label rhBMP‑2 Cervical Use: High Risk; May Be Denied

Off‑label use of rhBMP‑2 in the cervical spine is associated with increased risk of serious, potentially life‑threatening adverse events. The FDA has warned that off‑label cervical application can cause airway or neurologic structure compression. Such requests require strong justification and may be denied.

Explicitly document why alternatives (including autograft and approved approaches) are unsuitable.
Include informed‑consent discussion of increased risks and supporting literature.
Requests for cervical rhBMP‑2 should reference FDA safety communications.

Denial Risk

Evidence Limitations May Affect Coverage Determination

Evidence limitations — including small sample sizes, short follow‑up, heterogeneous devices/products, and selection bias — may affect coverage determinations. If the submitted evidence is low quality or not generalizable, coverage may be denied as not meeting medical‑necessity standards.

Provide high‑quality comparative evidence when available (RCTs, systematic reviews, long‑term follow‑up).
If evidence is limited, include rationale for why the member is an appropriate candidate despite gaps in the literature.

Denial Risk

Denial Risk for Ceramic‑Based Products (Used Alone or with BMA)

Ceramic‑based products used alone or combined with bone marrow aspirate (BMA) are considered unproven and may be denied as not medically necessary unless strong, product‑specific evidence is provided.

If requesting coverage for a ceramic‑based product, submit product‑specific clinical studies demonstrating safety and effectiveness for the intended spinal application.
Document prior use or trial of established graft options and why they are unsuitable for this patient.

Documentation Required

Medical Records Required for Reviews

Medical records may be requested to assess whether clinical criteria for coverage are met. Records must fully support the medical necessity of the requested service; their provision does not guarantee coverage.

Include relevant medical history, physical examination findings, and results of pertinent diagnostic tests or imaging.
Provide prior surgical records if the request is for revision procedures or pseudoarthrosis treatment.
Ensure documentation is legible and available on request.

Documentation Required

Document Fusion Assessment Methods, Timepoints, and Outcomes

When osteobiologics such as rhBMP‑2 or alternatives are used, document objective fusion assessment methods, timing, and outcomes. Include how fusion was assessed (e.g., CT, thin‑slice CT, radiographs), specific timepoints (e.g., 6, 12 months), and patient‑reported outcomes or functional scores when available.

Report fusion success rates and imaging modality used for assessment (CT preferred for fusion confirmation).
Provide perioperative and follow‑up functional measures (ODI, VAS) and note any reoperations or adverse events.
Describe the expected timeline for fusion and the actual follow‑up schedule.

Documentation Required

Imaging and Follow‑Up Documentation

Document imaging modalities and follow‑up schedule used to evaluate fusion and device performance. Include modality details (e.g., thin‑slice CT, reconstructed views, periodic radiographs), dates of imaging, and comparative readouts over time.

Provide preoperative and serial postoperative imaging reports with dates.
If CT imaging was used, include slice thickness and whether fusion was assessed with multiplanar reconstructions.
Include clinician interpretation of imaging relative to fusion status and any adjunctive imaging‑based quantification if available.

Step Therapy

Prefer Autograft Before Osteobiologics

Prefer autograft (e.g., iliac crest bone graft or local autograft with bone marrow aspirate) as first‑line graft material when feasible. Osteobiologics and substitutes should generally be considered after autograft has been determined unsuitable or unavailable.

Document attempts or contraindications to autograft harvesting (e.g., prior harvest, infection risk, insufficient quantity).
If autograft is not used, explain rationale and document why established graft options are not appropriate for this patient.

Step Therapy

Prefer Established Graft Options First

Prefer established graft options (autograft, standard allograft, DBM) before using newer or less‑proven substitutes. Evidence does not consistently establish superiority of many substitutes over autograft.

Document prior use, failure, or contraindication to established graft options when requesting newer substitutes.
Provide comparative evidence supporting the alternative product for the specific clinical scenario.

Step Therapy

Stepwise Graft Selection Rationale

When using graft extenders or substitutes, follow a stepwise rationale: show prior consideration of autograft, describe why autograft is unsuitable or inadequate, and provide product‑specific evidence for the proposed substitute or extender.

Include documentation of graft quantity requirements and why autograft volume would be insufficient.
If using a graft extender, document combination strategy (e.g., extender + local bone or BMA) and expected clinical benefit.

Policy contextConsidered a proven and medically necessary graft option when criteria are met.

InFUSE Bone Graft — rhBMP-2 product definition and approved indications

ProductInFUSE™ Bone Graft contains recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered on an absorbable collagen sponge.

Approved indications (policy excerpt)FDA-approved for certain spine indications; policy specifies InFUSE is medically necessary for lumbar interbody fusion when all criteria met (anterior/oblique approach with an FDA-approved interbody device; skeletally mature ≥18 years; degenerative disc disease L2–S1; single-level fusion).

Regulatory noteFDA PMA for InFUSE Bone Graft/LT-CAGE referenced (P000058); FDA approval information provided for reference only — approval alone is not a basis for coverage.

DBM (Demineralized Bone Matrix) — Definition and carrier requirement

DefinitionDemineralized Bone Matrix (DBM) is an allograft produced by dissolving the mineralized portion of bone and leaving the collagen matrix and retained growth factors.

Scaffold/carrier requirementDBM must be combined with a carrier that serves as a more potent osteoconductive scaffold — DBM alone provides weak osteoconductive capacity.

Policy contextDBM is considered proven and medically necessary when not combined with products listed as unproven/not medically necessary.

rhBMP-2 (Infuse) — Recombinant human BMP-2 and approved use details

DefinitionRecombinant human bone morphogenetic protein-2 (rhBMP-2) is an osteoinductive protein produced by recombinant DNA technology used to stimulate bone formation, commonly delivered on an absorbable collagen sponge (InFUSE).

Efficacy evidenceSystematic reviews and RCTs support use of rhBMP-2 (InFUSE) for select lumbar interbody fusion (L2–S1) with improved or comparable fusion rates versus iliac crest bone graft in some trials; one systematic review reported A1 evidence for Infuse in L2–S1 ALIF.

Safety considerationsAssociated with unique complications; FDA warnings and systematic reviews indicate increased adverse events with cervical use — off-label cervical application can cause life‑threatening events and is discouraged without strong justification.

Ceramic-based products (BCP, HA/β-TCP) — Description as synthetic osteoconductive scaffolds

DescriptionCeramic-based products (e.g., biphasic calcium phosphate, hydroxyapatite, β-tricalcium phosphate, calcium sulfate) are synthetic mineral salts produced at high temperatures that function as osteoconductive scaffolds varying by composition, porosity and resorption characteristics.

Clinical evidenceEvidence is heterogeneous; some products show noninferiority or favorable fusion rates in select trials (e.g., MagnetOs Granules), but overall high-quality, long-term evidence is insufficient to support broad coverage without product-specific data.

Policy stanceCeramic-based products used alone or in combination with other grafts and/or Bone Marrow Aspirate (BMA) are listed as unproven and not medically necessary in the policy unless product-specific evidence supports coverage.

Human amniotic tissue — Definition and limited evidence for spinal fusion efficacy

DefinitionHuman amniotic tissue refers to allogeneic placental membrane/tissue products (amniotic membrane) investigated for orthopedic applications.

Evidence summaryLimited evidence in human models shows inadequate support that amniotic tissue membrane improves outcomes in lumbar spine fusion; long-term safety and efficacy have not been established.

Policy implicationConsidered unproven and not medically necessary for spinal fusion pending further research and supportive clinical data.

SiCaP — silicate-substituted calcium phosphate material and aggregate fusion rate reporting

MaterialSilicate-substituted calcium phosphate (SiCaP) is a synthetic bone graft material evaluated across multiple studies.

Reported outcomesPooled evidence across studies reports a mean fusion rate of approximately 93% for SiCaP in spinal fusion series, though heterogeneity limits definitive conclusions.

Evidence limitationsHigh heterogeneity among studies and need for higher-quality trials limit generalizability despite promising radiographic fusion rates.

bioactive glass — synthetic silica-based materials and claims regarding HCA formation and osteoconductivity

DefinitionBioactive glass are synthetic silica-based materials typically composed of SiO2, CaO, Na2O, and P2O5 that are claimed to promote rapid hydroxyl carbonated apatite (HCA) formation and bone bonding.

Claims vs evidenceAlthough claimed to enhance HCA formation and osteoconductivity, there is insufficient high-quality evidence to determine efficacy and safety compared with established grafts.

Policy positionBioactive glass is considered investigational/unproven for spinal fusion in absence of robust comparative RCT data.

Allograft (structural) — Structural cortical or corticocancellous bone definitions

DefinitionStructural allograft refers to cortical or corticocancellous bone (fresh-frozen or freeze-dried) used to provide mechanical support in spinal fusion procedures.

Regulatory noteAllografts are considered human tissue/HCT/P when minimally manipulated; if combined with other materials the product may be regulated as a device by FDA.

Policy contextUsed with or without autograft; considered a proven option unless specifically listed as unproven in the policy.

rhBMP-2 — recombinant human BMP-2 associated with unique complications and conditional recommendations

DefinitionRecombinant human BMP-2 (rhBMP-2) is an osteoinductive protein used as a bone graft adjunct to stimulate bone formation; InFUSE is a commonly referenced rhBMP-2 product.

Safety considerationsrhBMP-2 use is associated with unique complications; systematic reviews and FDA communications identify increased adverse events with cervical use and other safety signals that require surgeon awareness.

Policy recommendationsrhBMP-2 (InFUSE) is recommended only for specified indications (e.g., L2–S1 single-level lumbar interbody fusion per policy) and is unproven/not medically necessary for indications outside those specified.

Osseointegration — Definition added to the policy

DefinitionOsseointegration is the stable anchorage of an implant achieved by direct bone-to-implant contact.

Policy noteDefinition added to the policy glossary to clarify implant-bone interface outcomes.

Clinical relevanceUsed to describe implant fixation and long-term stability in fusion procedures and device assessments.

Osteoconduction — Definition added to the policy

DefinitionOsteoconduction: bone grows on the surface; a process seen with bone implants where the scaffold permits new bone in-growth.

Clinical relevanceDescribes scaffold property of many synthetics and allografts used in fusion to enable bone formation along surfaces.

Policy noteDefinition added to the policy glossary to standardize terminology across coverage decisions.

Osteoinduction — Definition added to the policy

DefinitionOsteoinduction is the process by which osteogenesis is induced via recruitment and stimulation of immature cells to develop into preosteoblasts.

Clinical relevanceGrowth factors (e.g., BMPs) provide osteoinductive signals that drive bone formation beyond mere scaffolding.

Policy noteDefinition added to the policy glossary to align with clinical evidence discussions of biologic grafts.

Allograft / Autograft / Bone Marrow Aspiration — Updated definitions in the policy

Summary of updatesDefinitions for Allograft, Autograft, and Bone Marrow Aspiration were updated in the policy; new definitions for Osseointegration, Osteoconduction, and Osteoinduction were added.

ImplicationUpdated definitions clarify terminology used throughout the policy and support consistent application of coverage criteria.

Documentation noteSee Policy History/Revision Information for the 12/01/2025 updates to definitions and supporting sections.