RetiredUnitedHealthcarePolicy CS009LA.Q

Bone grafts and biologic adjuncts for spinal fusion

Policy governs coverage and medical necessity of autografts, allograft-based products, DBM, BMP (InFUSE), cell-based allografts, ceramic and synthetic bone graft substitutes, and related devices for spinal fusion in Louisiana members.

Policy Summary

PayerUnitedHealthcare

PolicyBone grafts and biologic adjuncts for spinal fusion

Policy CodePolicy CS009LA.Q

Change TypeRetired for Louisiana membershipmaterial coverage updates

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionProvide complete medical records and imaging (including fusion assessment at 6 and 12 months) to support medical necessity and prior authorization reviews.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying Ceramic-Based Products (e.g., b-TCP, 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.

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

Added medical records documentation language describing required content to support medical necessity determinations.

Added definitions for Osseointegration, Osteoconduction, and Osteoinduction and updated definitions for Allograft, Autograft, and Bone Marrow Aspiration.

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

InFUSE L2-S1Specific covered indication

InFUSE/MASTERGRAFT posterolateralCovered device/indication

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Coverage Criteria and Policy Determinations

InFUSE (rhBMP-2) — lumbar interbody

Covered when ALL of the following are met for InFUSE (rhBMP-2) lumbar interbody:

InFUSE lumbar interbody coverage: Approach is anterior or oblique AND used in conjunction with an FDA-approved interbody fusion device; patient is skeletally mature (18 years of age or older or radiographic evidence of epiphyseal closure) with degenerative disc disease (DDD); fusion involves vertebral bodies L2–S1, with or without spondylolisthesis of no more than grade 1 (<=25% displacement) at the involved level; single-level fusion only.

From coverage rationale (InFUSE approved L2–S1).

InFUSE/MASTERGRAFT — posterolateral revision

Covered when ALL of the following are met for InFUSE/MASTERGRAFT Posterolateral Revision Device System:

InFUSE/MASTERGRAFT posterolateral revision coverage: Device is implanted via a posterolateral approach; presence of symptomatic posterolateral lumbar spine pseudoarthrosis; patient is skeletally mature (older than 21 years of age or radiographic evidence of epiphyseal closure); autologous bone and/or bone marrow harvest is not feasible or is not expected to promote fusion; device and use are consistent with FDA indications, contraindications, warnings, and precautions.

From coverage rationale for InFUSE/MASTERGRAFT posterolateral revision.

Unproven / Not Medically Necessary

Unproven and not medically necessary due to insufficient evidence of efficacy and/or safety:

Unproven allograft-based and adjunct products: Allograft-based cell-based products (e.g., mesenchymal stem cell preparations), human amniotic tissue materials (including amniotic fluid stem cell substitutes), recombinant human BMP-2 (InFUSE) and InFUSE/MASTERGRAFT when used for indications other than those explicitly listed as covered, 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), bioactive glass used alone or in combination with grafts/BMA, and Expandable Interbody Fusion Systems.

Listed as unproven and not medically necessary per coverage rationale and exclusions.

Evidence-based coverage considerations

Coverage considerations based on available evidence and safety signals:

rhBMP-2 lumbar (L2–S1): Randomized trials and systematic reviews report higher fusion rates with rhBMP-2/Infuse versus iliac crest bone graft for lumbosacral (L2–S1) interbody fusion, with benefits such as reduced surgical time and blood loss; use should be limited to FDA-approved L2–S1 indications.FDA-approved L2–S1

Supports coverage when criteria met; see systematic review evidence.

rhBMP-2 off-label cervical: Systematic reviews and ECRI assessments report higher rates of adverse events with rhBMP-2 in cervical fusion and FDA warnings note life‑threatening events (e.g., airway/neurologic compression); off-label cervical use carries heightened safety concern and requires strong justification or may be excluded.avoid or require strong justification/prior auth

Safety signal warrants restrictive approach to off-label cervical use.

Allograft and cell-based products:

Evidence summary findings from RCTs, prospective, retrospective series, and systematic reviews

Findings summarized from randomized trials, prospective studies, retrospective series, and systematic reviews:

General evidence summary: Multiple products (including i-FACTOR/ABM/P-15, MagnetOs, AttraX Putty, CBGS, SiCaP, Bicera, SINTLife, and bioactive glass products such as BGS-7 and BioSphere) have published studies reporting fusion rates and improvements in patient-reported outcomes, but study quality, sample size, and follow-up durations vary widely; larger multicenter RCTs and longer-term data are frequently recommended.

Evidence heterogeneous; see systematic reviews and ECRI assessments.

Intra-patient randomized noninferiority trials: Some intra-patient randomized noninferiority trials (e.g., MagnetOs Granules, AttraX Putty) reported noninferiority and in some analyses apparent superiority versus autograft for posterolateral fusion, but limitations include intra-patient design and questions about outcome measures and long-term material behavior.

Promising but limited by design and follow-up.

Limited RCTs and prospective data: Several products have small RCTs, pilot studies, or single-center prospective series (e.g., CBGS in XLIF, SINTLife pilot, BGS-7 4-year follow-up) showing favorable fusion metrics and PROs but constrained by small sample sizes and heterogeneity.

Guideline-based Indications and Considerations

Guideline-based recommendations and indications summarized from specialty societies:

Society recommendations summary: Society guidance (AANS, NASS) supports DBM as a graft extender for 1–2 level instrumented posterolateral fusions; hydroxyapatite/b-TCP and calcium sulfate mixed with autograft are options as substitutes or extenders in certain posterolateral and interbody settings; rhBMP-2 may be considered as an adjunct in selected high-risk fusion scenarios (e.g., high risk for nonunion or revision surgery) but is not recommended for routine anterior/posterior cervical fusions or routine single-level posterolateral fusions in healthy adults; rhBMP-2 use is associated with unique complications clinicians should consider.

Summarizes AANS/NASS guidance and indications/contraindications.

Expandable Interbody Systems — Evidence

Evidence summaries regarding expandable interbody fusion systems and comparison to static cages:

Evidence for expandable devices: Current evidence for expandable interbody fusion systems is low-quality and predominantly retrospective; some studies report improved radiographic parameters (disc height, foraminal height, segmental lordosis) and favorable patient-reported outcomes, while meta-analyses show increased anterior disc height and segmental lordosis but no clear clinical benefit over static cages; prospective randomized trials with larger sample sizes and longer follow-up are lacking.

Expandable devices considered unproven pending higher-quality evidence.

Not medically necessary: Ceramic-based products and BMA

Coverage rationale and criteria summary

Ceramic-based products not medically necessary: 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 considered unproven and not medically necessary.

Operational basis for noncoverage decisions for ceramic-based products and BMA.

Benefit determination and policy application

Benefit determination and policy use

Benefit determination governs coverage: Benefit coverage for health services is determined by federal, state, or contractual requirements; in the event of conflict, those requirements govern. UnitedHealthcare may modify policies and may use third-party tools (e.g., InterQual) to assist in administering benefits; medical records documentation may be required to assess whether a member meets clinical criteria for coverage.

Operational guidance for application of the policy.

This policy designates several classes of grafts, biologic materials, and interbody devices as unproven and not medically necessary when used alone or in specified combinations because the available clinical evidence is insufficient to establish safety and effectiveness. Specifically, the scope includes: expandable interbody fusion systems; cell-based allograft products (e.g., mesenchymal stem cell–containing allografts); human amniotic tissue materials; ceramic-based products (for example, beta tricalcium phosphate, calcium phosphate, calcium sulfate) used alone or in combination with other grafts or graft components including bone marrow aspirate (BMA); and bioactive glass used alone or with other grafts. The policy applies these investigational or not medically necessary determinations to these product classes except where coverage is explicitly stated elsewhere in the policy (for example, InFUSE for specified lumbar indications and InFUSE/MASTERGRAFT for specified posterolateral revisions).

UnitedHealthcare highlights important safety concerns for off‑label cervical use of recombinant human BMP‑2 (InFUSE). Published assessments and systematic reviews report higher rates of adverse events with rhBMP‑2 in cervical fusion compared with other bone substitutes, and the FDA has issued warnings that off‑label cervical use can cause life‑threatening complications (for example, airway compression and neurologic compromise). For these reasons, rhBMP‑2 is restricted to its FDA‑approved lumbosacral indication (L2–S1) in this policy, and off‑label cervical application requires strong justification and may be subject to denial or heightened review.

Ceramic-based products and bioactive glass encompass a heterogeneous group of synthetic graft materials (e.g., hydroxyapatite, biphasic calcium phosphate, b‑TCP, and silica‑based bioactive glasses). The literature contains limited, variable‑quality clinical data and substantial heterogeneity in product composition and outcomes. Because of insufficient high‑quality evidence demonstrating safety and efficacy or comparative benefit to autograft/ICBG, these products are considered investigational or not medically necessary when used alone or in combination with other grafts (including BMA) until robust comparative trials and longer‑term outcome data are available.

Expandable interbody fusion systems lack adequate prospective randomized trial data with sufficiently large sample sizes and long‑term follow‑up to demonstrate a clear clinical benefit. Systematic reviews and meta‑analyses report improved radiographic parameters (for example, anterior disc height and segmental lordosis) but no consistent improvement in patient‑reported outcomes compared with static cages. In the absence of robust RCT evidence demonstrating improved clinical outcomes, expandable interbody systems are considered unproven by this policy.

This policy has been retired for Louisiana plan membership; UnitedHealthcare disenrolled Louisiana membership under this policy effective April 1, 2026. Operational and plan‑specific benefit determinations for Louisiana members are no longer governed by this policy as of that date.

Policy scope addresses a range of biologic grafts and adjuncts. Cell‑based allografts and human amniotic tissue materials are listed as investigational due to limited human clinical evidence. Ceramic and synthetic products (including beta‑tricalcium phosphate, calcium phosphate, calcium sulfate) and bioactive glass are considered unproven when used alone or combined with other grafts or BMA because available studies are heterogeneous and insufficient to establish clinical benefit. Separately, InFUSE (rhBMP‑2) is covered only for the specified lumbar interbody indications (L2–S1) meeting the policy’s criteria, and the InFUSE/MASTERGRAFT posterolateral revision system is covered only when used per FDA indications and the policy’s listed criteria.

Specific products and product families cited in the evidence review lack sufficient high‑quality clinical data to support routine coverage. Examples called out in the clinical assessments include PrimaGen and OsteoAMP, where ECRI found few or no comparative studies versus autograft and limited data overall. Human amniotic tissue materials similarly have sparse human evidence with uncertain long‑term safety and effectiveness for lumbar fusion.

Several named ceramic and bioactive glass products are noted in the evidence reviews as having inadequate clinical evidence (few or no randomized controlled trials or high‑quality comparative data). Examples include newer resorbable biphasic calcium phosphate putties and certain bioactive glass formulations; ECRI and systematic reviews found insufficient published clinical studies to determine comparative safety or effectiveness for lumbar fusion indications.

A recent meta‑analysis of studies comparing expandable versus static interbody cages included 13 studies with approximately 1,700 patients and found that expandable cages increased anterior disc height and segmental lordosis but produced no clear clinical benefit in terms of pain or disability (no differences in back pain, leg pain, or Oswestry Disability Index). The authors concluded that expandable cages do not demonstrate clear superiority over static cages based on available data and that higher‑quality RCTs are needed.

Consistent with the policy’s not medically necessary determinations, ceramic‑based products such as beta‑tricalcium phosphate, calcium phosphate, and calcium sulfate — whether used alone or combined with other grafts or with bone marrow aspirate (BMA) — are considered unproven and not medically necessary for enhancement of spinal fusion until robust comparative evidence demonstrates clinically meaningful benefit.

Coding and Regulatory References

Applicable/Referenced CPT CodesCPT

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

No explicit codes in this excerptmixed

No codes listed

Regulatory statuses citedmixed

510(k)	FDA premarket notification clearance referenced for multiple devices (Bicera, InFUSE, OptiMesh, Duo).
De Novo	OptiMesh expanded indications via De Novo classification (2020).
HDE	Humanitarian Device Exemption referenced for InFUSE/MASTERGRAFT (2008).

FDA-cleared/approved devices referencedmixed

FDA device references

i-FACTOR (510k), InFUSE/MASTERGRAFT (HDE), OptiMesh (510k and De Novo), Duo (510k)

Imaging follow-up — typical fusion assessment timepoints used in studies

Typical post-op imaging timepointsStudies assessing fusion commonly report imaging-based fusion assessment at ~6 months and 12 months postoperatively (CT or serial radiographs).

Imaging modalities usedComputed tomography (CT) and serial radiographs were used in studies to determine fusion status at these timepoints.

Purpose of serial imagingSerial imaging at 6 and 12 months documents progression to solid arthrodesis and supports clinical outcome reporting (ODI, VAS).

Provider Requirements, Prior Authorization, and Documentation

Billing Rule

Coding and documentation for review

Coding and billing codes relevant to bone grafting and related procedures may be requested during review to determine coverage and payment. Providers should include the applicable CPT/HCPCS/ICD-10 codes on the prior authorization and claim, plus operative reports and device/product names. Absence of appropriate coding or documentation may delay review or result in denial.

Include procedure codes and product/device names on requests and claims
List bone marrow aspiration (20939) and allograft codes (20930, 20931) when performed
Unlisted spine procedures (22899) should be accompanied by full operative documentation

Prior Authorization

Prior authorization required for off‑label cervical rhBMP‑2

Background and Clinical Context

Autologous iliac crest bone graft (ICBG) remains the clinical reference standard for spinal fusion because it provides the three key biologic mechanisms necessary for bone healing: osteoconduction (a scaffold for new bone growth), osteoinduction (stimulation of progenitor cells to become bone‑forming cells), and osteogenesis (transfer of living osteogenic cells). Although effective, ICBG is associated with donor‑site morbidity, which is why alternatives and adjunctive products are studied, but many alternatives have not yet demonstrated equivalent, high‑quality evidence of efficacy and safety.

Key Definitions and Terminology

Allograft (allogeneic graft/homograft)

DefinitionAllograft: transplant of an organ or tissue from one individual to another of the same species with a different genotype; also called allogeneic graft or homograft.

Regulatory noteAllografts are considered tissues for transplantation; minimally manipulated human bone is regulated as HCT/P by the FDA.

SynonymsAlso referred to as allogeneic graft or homograft (MedicineNet, 2022).

Autograft

DefinitionAutograft: tissue grafted into a new position in the body of the same individual.

Clinical contextIliac crest bone autograft (ICBG) remains the gold standard for many spinal fusion indications despite donor-site morbidity.

Policy Revision History

2026-04-01policy_retirementLatest

Policy retired for Louisiana plan membership; Louisiana members disenrolled from this policy.

2026-01-01coverage_rationale_revision

Added coverage rationale clarifying that ceramic-based products (e.g., b-TCP, calcium phosphate, calcium sulfate) used alone or with other grafts and/or Bone Marrow Aspirate (BMA) are unproven and not medically necessary.

2026-01-01

Policy Summary

PayerUnitedHealthcare

PolicyBone grafts and biologic adjuncts for spinal fusion

Policy CodePolicy CS009LA.Q

Change TypeRetired for Louisiana membershipmaterial coverage updates

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionProvide complete medical records and imaging (including fusion assessment at 6 and 12 months) to support medical necessity and prior authorization reviews.

SourceLink

On This Page

Prior Authorization

Prior authorization for novel ceramic/bioactive grafts and expandable devices

Prior authorization is likely required for novel ceramic, bioactive glass, or other newer synthetic grafts and expandable interbody systems given limited high‑quality evidence. Submit clinical rationale, prior treatments attempted, and any supporting published evidence or device FDA status.

Include prior conservative and surgical treatments and why autograft/established allograft/DBM are unsuitable
Provide device/product name, manufacturer, and FDA 510(k)/De Novo/HDE/PMA status when available
Attach peer‑reviewed evidence or registries supporting the specific product's use

Prior Authorization

Prior authorization and benefit determination

Benefit determination is governed by federal, state, and contract requirements; submission of medical records may be required to assess whether the member meets coverage criteria. Prior authorization approvals are not guarantees of payment; final benefit determination occurs at claims adjudication.

Provide complete medical records, operative reports, imaging, and device documentation upon request
Note: state Medicaid fee schedules may exclude certain codes (see Applicable Codes)
Prior authorization decisions do not override contractual exclusions or state rules

Denial Risk

Off‑label cervical rhBMP‑2 risk

Off‑label cervical use of rhBMP‑2 carries specific life‑threatening risks (e.g., airway compression, neurologic compromise) documented by the FDA and systematic reviews. Requests for this use will be reviewed with heightened scrutiny and require detailed informed consent and risk mitigation plans.

Include specific documentation of the anticipated anatomic risk and steps to mitigate airway/neurologic compromise
Provide multidisciplinary consultation notes if applicable (ENT/anesthesia)

Denial Risk

Use of ceramic‑based products and BMA — documentation and denial risk

Ceramic‑based products used alone or combined with bone marrow aspirate (BMA) have insufficient/ mixed evidence; use of these products without established autograft or proven allograft/DBM alternatives may be considered not medically necessary. Submissions relying on ceramic products as the sole graft material should include strong supporting evidence and rationale for not using autograft.

Document why iliac crest autograft (ICBG) or established allograft/DBM cannot be used
If reporting use with BMA, provide technique and rationale; standalone ceramic + BMA may be denied

Denial Risk

Devices/implants lacking high‑quality evidence

Devices or implants that lack high‑quality prospective randomized evidence (e.g., certain expandable interbody systems, novel bioactive implants) may be considered investigational or not covered. Provide long‑term clinical and radiographic follow‑up data when available to support effectiveness.

Submit available prospective data, registry results, and CT/serial radiograph outcomes up to 1–2 years when possible
If device lacks RCT evidence, state this explicitly and include rationale for use over established alternatives

Denial Risk

Denial risk for ceramic‑based products and BMA

There is an increased denial risk when ceramic‑based products or use of BMA alone are the sole grafting strategy for standard fusion indications. Documentation must justify deviation from accepted graft hierarchy (autograft → established allograft/DBM → novel substitutes).

Explain why autograft (iliac crest) or established allograft/DBM are not feasible or were unsuccessful
Provide prior operative reports if previous harvest or graft failure is asserted

Documentation Required

Long‑term radiographic and clinical follow‑up documentation

Long‑term radiographic (CT and serial radiographs) and clinical follow‑up (PROMs, ODI, VAS) used in trials are often requested to document fusion status and outcomes. Trials frequently used CT at 1–2 years to assess fusion; include these imaging studies when available to support medical necessity.

Provide CT scans or radiographic reports at 12 and/or 24 months when available
Include objective outcome measures (ODI, VAS) and documentation of fusion status from imaging

Documentation Required

FDA clearance/510(k)/De Novo or HDE status — include in submission

Document FDA clearance status for devices and implants (510(k), De Novo, PMA, HDE) when submitting requests. FDA status is informational but supports assessment of the device's intended use and regulatory indications.

Include links or FDA 510(k)/De Novo/PMA/HDE identification where available
Examples: InFUSE LT‑CAGE PMA supplements, OptiMesh and Duo expandable systems 510(k)/De Novo/HDE references

Documentation Required

Medical records documentation requirements

Medical records must fully support medical necessity and may be requested for review. Required documentation includes but is not limited to: relevant medical history, physical exam, diagnostic test results, prior treatment attempts, operative reports, device/product name and manufacturer, informed consent, and pre/post‑operative imaging. Lack of adequate records may lead to denial.

Provide legible, contemporaneous documentation of symptoms, prior conservative management, and failed prior treatments
Include operative notes describing graft materials used, volumes, and harvest sites if autograft was obtained (iliac crest)
Attach informed consent and multidisciplinary consult notes if relevant

Step Therapy

Comparative results are mixed — consider autograft (iliac crest) first

Comparative evidence across graft materials is mixed; many reviews report comparable outcomes between rhBMP‑2 and iliac crest bone graft for approved lumbar indications but insufficient evidence to conclude superiority of novel substitutes. Providers should generally consider autograft (iliac crest) or established allograft/DBM before novel products unless contraindicated.

Document reasons autograft (iliac crest) is not an option (e.g., prior harvest, medical contraindication)
If using rhBMP‑2 outside lumbar labeled indications, provide explicit justification and safety monitoring plans

Demineralized Bone Matrix (DBM)

DefinitionDemineralized Bone Matrix (DBM): an allograft produced by dissolving the mineralized portion of bone, leaving the collagen matrix and retained growth factors; must be combined with a carrier to serve as an osteoconductive scaffold.

Clinical useDBM combined with autograft may be indicated for posterior instrumented fusion; limited evidence for stand-alone use in non-instrumented anterior fusions.

Composition/functionCollagen matrix provides weak osteoconductive capacity while retained growth factors are osteoinductive; requires a carrier for scaffold function.

rhBMP-2 / Infuse (delivery form and approved indications)

DefinitionrhBMP-2 / Infuse: recombinant human bone morphogenetic protein-2 delivered in an absorbable collagen sponge (Infuse Bone Graft); intended to promote vertebral fusion by inducing bone formation.

FDA-approved spinal indicationIn the U.S., Infuse is approved for lumbosacral spine fusion (L2–S1) only; off-label cervical use has been associated with life‑threatening adverse events and FDA warnings.

Intended benefitDesigned to achieve vertebral fusion without the need for autologous bone graft harvest (iliac crest).

Allograft / cell-based allograft (examples: OsteoCel, PrimaGen)

DefinitionAllograft / cell-based allograft: products derived from donated human bone sometimes processed to preserve cells (examples include OsteoCel and PrimaGen).

Evidence summaryEvidence for cell‑based allografts is limited in quantity and quality; comparative effectiveness versus autograft is not well established.

Processing noteThese products are minimally processed to preserve bone-forming cells in some formulations; product-specific data are sparse or absent for some brands.

Ceramic-based products (materials and examples)

Definition/materialsCeramic-based products: synthetic bone graft substitutes composed of mineral salts (e.g., hydroxyapatite, beta‑tricalcium phosphate, biphasic calcium phosphate, SiCaP, magnesium-doped HA) produced at high temperatures to create osteoconductive structures.

ExamplesRepresentative products cited include AttraX Putty, MagnetOs Granules, Bicera, SINTLife, and other calcium phosphate/tricalcium formulations.

Typical useUsed as standalone grafts or combined with autograft/allograft in spinal fusion procedures; clinical outcomes vary by composition and product.

Structural allograft (cortical/corticocancellous, uses)

DefinitionStructural allograft: cortical or corticocancellous allograft bone (fresh‑frozen or freeze‑dried) used with or without autograft for structural support in spinal reconstruction.

IndicationsIndicated for anterior cervical reconstruction (ACDF, corpectomy) and posterior cervical/occipitocervical instrumented fusion and other specified fusion scenarios.

FormsMay be used as structural cortical grafts or corticocancellous grafts, often combined with instrumentation or synthetic cages for interbody fusion.

Graft source definitions updated — Allograft, Autograft, Bone Marrow Aspiration

AllograftUpdated definition: transplant of tissue from one individual to another of the same species with different genotype (allogeneic/homograft).

AutograftUpdated definition: tissue grafted into a new position in the body of the same individual; ICBG remains the clinical gold standard for many fusions.

Bone Marrow Aspiration (BMA)Updated definition: removal of a small amount of bone marrow in liquid form for use as graft material or for examination; BMA may be combined with other grafts but use with certain ceramics/BMA is designated unproven in this policy.