ModifiedUnitedHealthcarePolicy CS009LA.Q

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

Policy governing coverage and medical necessity of bone grafts, biologics, and implantable bone-healing enhancement products used to augment spinal fusion for UnitedHealthcare Community Plan in Louisiana.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS009LA.Q

Change TypeClarification and additions to coverage rationale, documentation, and definitions

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionProvide complete medical record documentation (history, exam, and pertinent diagnostic test results) upon request to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Added language to clarify Ceramic-Based Products (e.g., beta tricalcium phosphate (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.

Added language indicating that medical records documentation may be required to assess whether the member meets the clinical criteria for coverage and that documentation must fully support medical necessity.

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

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

State-specificApplies to

Includes rhBMP-2Named covered biologic

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Multiple allografts listedUnproven categories

Many productsEvidence limited

5 codesCoding provided

Coverage and Medical Necessity Criteria

Medically necessary coverage criteria

Covered when ALL criteria below are met for the specified products and indications:

InFUSE (rhBMP-2) — lumbar interbody fusion: Use of recombinant human bone morphogenetic protein-2 (InFUSE) for lumbar interbody fusion is covered when ALL of the following are met: the surgical approach is anterior or oblique and the product is used in conjunction with an FDA‑approved interbody fusion device; the patient is skeletally mature (≥18 years of age or radiographic evidence of epiphyseal closure) with degenerative disc disease (DDD); the fusion involves vertebral bodies L2–S1 with spondylolisthesis of no more than grade 1 at the involved level; and the fusion is single‑level.

From policy proven/medically necessary listing (InFUSE lumbar spine).

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

Per FDA HDE indication and policy listing.

Proven alternatives and adjuncts: The following graft materials and implantable systems are considered proven/medically necessary when used appropriately for spinal fusion augmentation: autograft (including bone marrow aspirate), demineralized bone matrix (DBM) when not combined with products listed as unproven, allograft‑based products that are not separately designated as unproven, ceramic‑based products (e.g., b‑TCP, calcium phosphate, calcium sulfate) and bioactive glass when used alone or in combination with grafts (including BMA), and expandable interbody fusion systems when used consistent with device labeling and clinical justification.

Reflects policy listing of proven/medically necessary materials and devices.

Unproven / Not medically necessary

The following products and uses are considered unproven and not medically necessary due to insufficient evidence of efficacy and/or safety:

Allograft cell‑based and related products: Allograft‑based cell‑containing products (for example, products containing mesenchymal stem cells or other preserved bone‑forming cells) and human amniotic tissue materials (including amniotic fluid stem cell substitutes) are unproven and not medically necessary because available clinical evidence is limited, of very low quality, and insufficient to determine comparative effectiveness and safety.

Per ECRI and policy statements on cell‑based allografts.

Ceramic‑based products (policy clarification): 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 considered unproven and not medically necessary per this policy revision.

Per material policy clarification added to Coverage Rationale (01/01/2026).

Specific products lacking evidence: Named products lacking sufficient published clinical evidence (e.g., PrimaGen Advanced Allograft, OsteoAMP as assessed by ECRI) are considered unproven and not medically necessary until adequate comparative evidence is available.

Evidence summaries informing coverage

Key evidence assessments and gaps that informed coverage decisions:

ECRI assessments of specific allograft products: ECRI clinical evidence assessments (e.g., PrimaGen, OsteoAMP) identified little or no comparative clinical evidence to establish safety and effectiveness; conclusions emphasize the need for large prospective trials.

See ECRI assessments summarized in policy.

rhBMP‑2 evidence and safety concerns: Systematic reviews and larger studies demonstrate higher fusion rates with rhBMP‑2 in some contexts but also identify increased adverse events with cervical use; evidence quality and follow‑up limitations tempered recommendations for off‑label indications.

SRs and FDA warnings inform cautious use of rhBMP‑2, especially cervical fusion.

Ceramic‑based products evidence heterogeneity: Systematic reviews/meta‑analyses report mixed results for ceramic substitutes with heterogeneity across compositions and study designs; while some RCTs show noninferior fusion rates to autograft, limitations include intra‑patient designs, small samples, sponsorship concerns, and limited PROM attribution.

Policy cites multiple RCTs and systematic reviews highlighting limitations.

Evidence summaries relevant to coverage decisions

Summarized trial and synthesis findings most relevant to coverage decisions for ceramic/bioactive glass grafts and interbody implants:

iFactor/ABM/P‑15 (small studies/systematic review): Systematic review of five small studies (388 patients) found iFactor/ABM/P‑15 facilitated faster radiographic fusion versus traditional grafts and maintained similar patient‑reported outcomes, but studies were heterogeneous, often sponsored, and limited in size—requiring larger multicenter RCTs for confirmation.

See systematic review summary (chunks 36).

MagnetOs / biphasic calcium phosphate RCT evidence: Randomized intra‑patient noninferiority trials (for example MagnetOs, AttraX Putty) reported noninferiority or comparable fusion rates to autograft in instrumented posterolateral fusion, but intra‑patient design limits attribution of PROMs and longer‑term, larger RCTs are needed.

See chunks 37, 44 and related trial follow‑up (chunk 46).

SiCaP pooled outcomes: A systematic review/meta‑analysis of silicate‑substituted calcium phosphate (SiCaP) across heterogeneous studies reported a pooled mean fusion rate of approximately 93% with improvements in VAS and ODI, though high heterogeneity was noted and higher‑quality trials are recommended.

Expandable interbody fusion systems — evidence-based criteria

Evidence‑based considerations and the policy stance on expandable interbody fusion systems:

Evidence quality consideration: High‑quality randomized controlled trials with adequate sample size and long‑term follow‑up are lacking for many expandable interbody systems; most available data are retrospective or single‑center and at risk of bias, limiting certainty about patient‑centered benefits.

Policy notes lack of prospective RCTs and very low‑quality data for some systems (chunk 54).

Reported radiographic benefits: Observational studies report improvements in radiographic parameters (disc height, foraminal height, segmental lordosis) and in some cohorts improved patient‑reported outcomes up to two years, but these findings are not consistently confirmed in meta‑analyses.

See chunks 56 and 58 describing radiographic and PROM findings.

Meta‑analysis findings: Systematic reviews/meta‑analyses indicate expandable cages increase anterior disc height and segmental lordosis versus static cages, but they do not consistently demonstrate superior pain or ODI outcomes.

See chunks 55 and 57 summarizing meta‑analyses.

Osteobiologics and graft substitute guidance

Contextual guideline statements to inform appropriate use of osteobiologics and graft substitutes:

AANS guidance on DBM and b‑TCP: Per AANS guidance, demineralized bone matrix (DBM) may be used as a bone graft extender for 1–2 level instrumented posterolateral fusions; b‑TCP/local autograft can be an option as a substitute for iliac crest bone graft (AICB) in single‑level instrumented posterolateral fusion due to comparable fusion rates and outcomes.

See AANS guideline statements (chunk 59).

Hydroxyapatite and calcium extenders: Hydroxyapatite (HA) with local autograft/BMA may be an option as a substitute or graft extender for instrumented posterolateral fusion; evidence varies by composite and long‑term recommendations are limited.

See hydroxyapatite guidance (chunk 60).

Interbody fusion considerations: Use of substitutes for AICB in ALIF/PLIF/TLIF may be considered an option in certain settings (for example single‑level procedures) but evidence is insufficient to recommend rhBMP‑2 as a supplement for some standalone procedures; heterotopic bone formation has been observed with certain substitutes.

Regulatory considerations

Regulatory context affecting coverage and prior authorization expectations:

FDA device clearances and De Novo classifications: Several interbody devices and biologic grafts have received FDA 510(k) clearances or De Novo classifications (for example, i‑FACTOR, Duo Expandable Interbody Fusion System, OptiMesh) for specified lumbar indications; device labeling and cleared indications should be reviewed when considering coverage and prior authorization requirements.

See FDA premarket summaries and De Novo/510(k) references (chunks 69, 70).

Coverage Rationale (clarification)

Coverage rationale, material policy change, and required documentation for reviews:

Ceramic‑based products — policy clarification: Policy revision (01/01/2026) clarifies that Ceramic‑Based Products (for example, beta‑tricalcium phosphate, calcium phosphate, calcium sulfate) used alone or combined with other grafts and/or graft components including Bone Marrow Aspirate (BMA) are considered unproven and not medically necessary under this policy.

Material change recorded in Policy History/Revision Information (chunk 78) and coverage lists (chunks 3 and 4).

Documentation requirement for medical necessity: Medical records documentation must fully support medical necessity for requested services and may be requested for review; documentation should include relevant medical history, physical examination, diagnostic test results, and any prior treatments considered or tried.

Policy requires accessible, legible documentation and notes that documentation may be required (chunk 78 and authorization/documentation guidance).

Codes in the policy list are provided for reference only. Codes labeled with an asterisk (*) are not on the State of Louisiana Medicaid Fee Schedule and therefore are not covered by the State of Louisiana Medicaid Program. Inclusion of a code in this policy does not imply coverage or guarantee payment; benefit coverage is determined by federal, state, or contractual requirements.

Use of recombinant human bone morphogenetic protein-2 (rhBMP-2, InFUSE) for cervical fusion has been associated with a higher rate of adverse events compared with other bone substitutes and carries explicit FDA warnings for off‑label cervical use. Off-label cervical use may result in life‑threatening complications (for example, airway or neurologic compression) and requires strong justification or may be excluded.

Expandable interbody fusion systems are considered unproven for routine use because available evidence lacks adequately powered prospective randomized controlled trials and is generally of very low quality. Systematic reviews and device assessments report primarily retrospective cohorts and heterogeneous study designs, limiting confidence in claims of clinical efficacy.

Much of the evidence for expandable interbody systems is retrospective, single‑center, or observational, with short- to mid-term follow-up. These designs are prone to selection bias, confounding, and inconsistently reported patient‑oriented outcomes (pain, function), which limits ability to draw causal conclusions about safety or effectiveness.

Ceramic‑based products (for example, beta‑tricalcium phosphate, calcium phosphate, calcium sulfate) used alone or combined with other grafts or graft components, including Bone Marrow Aspirate (BMA), are stated in this policy revision as unproven and not medically necessary due to insufficient evidence of safety and efficacy.

Cell‑based allograft products (including products that preserve or deliver viable cells such as MSCs) and human amniotic tissue materials are designated unproven and not medically necessary because published clinical literature is limited, of very low quality, and does not establish comparative safety or effectiveness versus autograft or other established graft options.

Certain marketed products lack sufficient published clinical data to determine safety and effectiveness. Examples cited in evidence assessments include PrimaGen Advanced Allograft and OsteoAMP, where reviews found few or no comparative studies and existing reports were limited, retrospective, or at high risk of bias.

Specific novel or patient‑specific titanium implants (for example, the Aprevo system) have been assessed and found to have very low‑quality evidence, often limited to a single retrospective cohort; such devices may be considered not medically necessary when requested without higher‑quality comparative data demonstrating patient‑oriented benefit.

Available systematic reviews comparing expandable versus static interbody cages report improvements in radiographic measures (e.g., anterior disc height, segmental lordosis) but do not demonstrate consistent advantages in patient‑reported outcomes (pain, ODI). Superiority of expandable cages over static cages is not established.

For clarity, ceramic‑based products referenced throughout this policy include materials such as beta‑tricalcium phosphate (b‑TCP), calcium phosphate, and calcium sulfate. These materials vary by composition and manufacturing, and current evidence is insufficient to support routine use when used alone or combined with other graft components.

Procedure Codes and Billing

Applicable procedure 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.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Coding Note — Prior authorization required

Prior authorization is required for certain osteobiologic implants and adjuncts. Inclusion of a product in this policy or on a code list does not guarantee coverage; benefit determination is subject to federal, state, and contractual requirements.

Verify benefits and obtain prior authorization before scheduling procedures.
Listing of a code in the policy does not imply coverage or guarantee payment.

Prior Authorization

Prior Authorization for Off‑Label Osteobiologics — Caution for rhBMP-2 cervical use

Requests for off‑label cervical use of recombinant human BMP-2 (rhBMP-2/InFUSE) require special caution. Off‑label cervical application has been associated with life‑threatening adverse events (eg, airway or neurologic compression) and may be denied.

Document FDA‑approved indication and surgical approach when requesting rhBMP-2.
Off‑label cervical use: provide detailed justification and informed consent documentation.

Clinical Background and Evidence Context

Autologous iliac crest bone graft (ICBG) remains the clinical gold standard for spinal fusion because it provides combined osteoconductive, osteoinductive, and osteogenic properties. ICBG's biologic profile supports new bone formation, but its use is balanced against donor‑site morbidity; many synthetic and biologic substitutes are evaluated as alternatives to reduce that morbidity.

Definitions and Terms

inv-41: Definition — Allograft

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

Common examplesIncludes demineralized bone matrix (DBM) and structural/nonstructural allograft bone used in spinal fusion.

Clinical contextUsed as a nonautogenous bone graft material to avoid iliac crest harvest morbidity; indicated for structural and nonstructural applications per guidance.

Evidence noteEvidence for cell-containing allograft products (e.g., PrimaGen, Osteocel) is limited and comparative effectiveness versus autograft is generally insufficient.

inv-42: Definition — Autograft

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

Policy Revision History

2026-01-01policy_revisionLatest

Added coverage rationale clarifying that 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; added detailed medical records documentation requirements; added definitions for osseointegration, osteoconduction, and osteoinduction; updated Allograft, Autograft, and Bone Marrow Aspiration definitions; updated Clinical Evidence, FDA, and References sections.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS009LA.Q

Change TypeClarification and additions to coverage rationale, documentation, and definitions

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionProvide complete medical record documentation (history, exam, and pertinent diagnostic test results) upon request to support medical necessity.

SourceLink

On This Page

ECRI assessments indicate insufficient data for these products.

Expandable interbody systems without high‑quality evidence: Specific novel or patient‑specific expandable interbody implants (for example, Aprevo or other patient‑specific titanium implants) are considered investigational/unproven and not medically necessary when requested without high‑quality comparative evidence demonstrating patient‑oriented benefits and sustained safety.

Policy cites very low‑quality evidence and lack of RCTs for some expandable systems.

Overall evidence gap: Across osteobiologics and synthetic grafts, many product classes lack large, well‑conducted randomized controlled trials with patient‑oriented outcomes and adequate long‑term follow‑up, limiting definitive conclusions about comparative effectiveness and safety.

Recurring theme in evidence summaries and assessments.

Bioactive glass evidence: Retrospective and small prospective studies report favorable radiographic and clinical outcomes for bioactive glass putty/granules, but overall evidence quality is very low and RCTs comparing bioactive glass to ICBG are lacking.

See chunk 49 and ECRI summary.

Expandable interbody systems evidence synthesis: Systematic reviews and meta‑analyses of expandable versus static cages report improved anterior disc height and segmental lordosis with expandable devices but no consistent superiority for pain or ODI; available primary data are predominantly retrospective and heterogeneous.

See chunks 55 and 57.

Aprevo and patient‑specific implants: ECRI assessment for Aprevo patient‑specific titanium interbody implants found very low‑quality evidence (primarily retrospective cohort data) that did not report patient‑oriented outcomes—insufficient to establish effectiveness.

See chunk 54.

Coverage recommendation: Given the low level of evidence, heterogeneity among studies, and limited patient‑oriented outcome data, routine, unrestricted coverage for novel expandable interbody systems should be limited; requests should include device FDA indication, clinical rationale, and supporting documentation. Consideration of established alternatives (static cages, standard graft materials) is advised prior to approving novel devices.

Reflects policy recommendation to limit routine coverage and require justification (chunks 54, 57).

See interbody fusion guidance (chunk 62).

NASS‑aligned rhBMP‑2 guidance and limitations: Professional society guidance (NASS) supports rhBMP‑2 as an adjunct or substitute in select indications (ALIF, high‑risk nonunion, select PLIF/TLIF) but advises against routine use in anterior/posterior cervical fusion and routine single‑level posterolateral fusions in healthy adults; rhBMP‑2 has unique complication risks that must be considered.

See NASS recommendations (chunks 66, 67).

Prior Authorization

Prior Authorization for Novel Implants — Limited evidence may trigger prior auth

Novel or less‑established implantable systems (for example certain expandable or patient‑specific interbody implants) may require prior authorization due to limited prospective randomized evidence and small sample sizes.

Provide comparative evidence, procedure rationale, and device FDA clearance/labeling when requesting coverage.
Requests relying solely on small retrospective series may be denied.

Note

Device Clearance and Indications — Note on FDA 510(k)/De Novo implications

Device clearance pathway and labeled indications affect coverage determinations. 510(k) and De Novo clearances allow marketing but do not by themselves establish clinical effectiveness; include FDA decision and intended indication in requests.

Include FDA 510(k)/De Novo/K number and current labeled indication in prior authorization submissions.
If device use falls outside cleared/approved indications, provide supporting evidence and rationale.

Prior Authorization

Prior Authorization and Benefit Verification — Check federal/state/contractual requirements

Always verify member benefits and applicable legal requirements before performing services. Federal, state, and contractual benefit provisions may mandate different coverage rules than those summarized here.

Check for state‑specific mandates and plan exclusions prior to authorization.
Authorization does not guarantee payment — final determination depends on the member's benefit plan.

Step Therapy

Step Therapy — Not specified in this section

Step therapy requirements are not specified in this portion of the document. Refer to the member's benefit plan or utilization management tools for any applicable step therapy rules.

If step therapy is imposed by the plan, documentation of failure or contraindication to required prior therapies must be provided.

Step Therapy

Step Therapy Considerations — Consider requiring standard alternatives first

When high‑quality comparative evidence exists for standard grafts or devices, prior authorization may require documentation that standard alternatives were considered or tried first.

For requests involving newer biologics or devices, include rationale why standard options (eg, ICBG/autograft, static cages) are unsuitable.
Provide prior treatment history and objective reasons for selecting the investigational or less‑established option.

Prior Authorization

Consideration of Standard Grafts First — Require documentation that standard grafts were considered

Documentation should demonstrate that standard graft options, such as autologous iliac crest bone graft (ICBG) or other accepted grafts, were considered or are not feasible before approving newer or unproven products.

Include prior surgical history, graft availability assessment, and surgeon rationale if autograft is not feasible.
If bone marrow aspirate (BMA) or autograft was not used, document the clinical reason.

Step Therapy

Consider Established Alternatives First — Stepwise use of static cages before newer expandable systems

When proposing newer expandable interbody systems, documentation should show that established alternatives (eg, static cages) were considered and explain why an expandable device is clinically indicated.

Provide comparison of expected clinical benefit versus static cages and supporting literature.
Include device specifics, surgical approach, and anticipated impact on fusion or alignment.

Documentation Required

Required Medical Record Documentation — Documentation must fully support medical necessity

Medical records and operative documentation must fully support medical necessity. Insufficient or illegible records may lead to denial of the request.

Include relevant medical history, physical exam findings, diagnostic imaging, prior conservative treatments, and surgeon’s operative notes.
Maintain legible records and make them available upon request.

Documentation Required

Evidence and Fusion Assessment Documentation — RCTs, systematic reviews, and imaging-based assessments

Evidence supporting fusion and outcomes should be provided when available. Randomized controlled trials, systematic reviews, and imaging-based fusion assessments (eg, thin-slice CT) strengthen the case for coverage.

Include citations to RCTs or systematic reviews if used to support the request.
Provide radiographic fusion assessment (CT thin-slice) timing consistent with published studies when claiming fusion success.

Documentation Required

Radiographic Fusion Documentation — CT imaging and timing

Radiographic fusion documentation should reference appropriate imaging modality and timing. Thin-slice CT imaging used in clinical trials is preferred for fusion assessment when available.

Provide CT imaging reports (thin-slice) and date of imaging relative to index surgery.
When trial-based timing is cited, include the study reference and how the patient’s imaging aligns with that timing.

Documentation Required

Outcome and Radiographic Documentation — Include 2‑year radiographic and PROM data where available

When outcome data are available, include both radiographic results and patient‑reported outcomes (eg, ODI, VAS) up to two years where possible to support clinical benefit.

Include 1‑ and 2‑year PROMs and radiographic fusion data when available.
If long‑term outcomes are unavailable, explain why shorter‑term data are sufficient for the clinical decision.

Documentation Required

Medical Records Documentation Requirements — Records must fully support medical necessity

Medical records may be requested and must fully support medical necessity. Failure to provide requested records or incomplete documentation increases the risk of denial.

Respond promptly to medical records requests and include all pertinent documents.
Insufficient records are grounds for coverage denial.

Denial Risk

Denial Risk for Ceramic‑Based Products — Requests for ceramics alone or with BMA may be denied

Requests for ceramic‑based products used alone or combined only with BMA may be treated as unproven and carry a higher denial risk when evidence is insufficient to demonstrate clinical benefit.

If requesting ceramic materials as standalone therapy, provide high‑quality comparative evidence and clinical justification.
Be aware that some ceramic products were recently reclassified in the policy as unproven and not medically necessary in certain contexts.

Gold standardIliac crest bone autograft (ICBG) remains the 'gold standard' for spinal fusion due to osteoconductive, osteoinductive, and osteogenic properties.

Clinical considerationAutograft harvest is associated with donor-site morbidity (pain, infection, fracture, neurologic injury), which motivates alternative graft options.

inv-43: Definition — Bone Marrow Aspiration (BMA)

DefinitionBone Marrow Aspiration (BMA): removal of a small amount of bone marrow in liquid form for examination or use in grafting.

UseBMA may be combined with graft materials (e.g., ceramics, allograft) as a source of osteogenic cells or growth factors.

DocumentationWhen BMA is used in grafting, medical records should document the procedure and rationale for its use as part of the fusion strategy.

inv-44: Definition — InFUSE (rhBMP-2)

DefinitionInFUSE (InFUSE™ Bone Graft): a bone graft product that contains recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered on an absorbable collagen sponge to stimulate bone formation; approved for specified spine indications (e.g., select lumbosacral fusion).

Formulation & deliveryrhBMP-2 is provided via an absorbable collagen sponge (Infuse) and used in conjunction with an interbody fusion device for approved lumbar indications (L2–S1).

Clinical evidenceSystematic reviews and RCTs report Infuse offers comparable results to iliac crest bone graft with benefits of avoiding graft harvest and reduced surgical time/blood loss, within the limitations of available studies.

inv-45: Definition — Ceramic-Based Products / Bioactive Glass

DefinitionCeramic-Based Products / Bioactive Glass: mineral- or silicate-based synthetic materials (e.g., hydroxyapatite, calcium phosphate, beta-tricalcium phosphate, calcium sulfate, and bioactive glass) with osteoconductive properties; some bioactive glass formulations report osteoinductive activity.

ExamplesIncludes b-TCP, calcium phosphate, calcium sulfate, silicate-substituted calcium phosphate (SiCaP), and glass-ceramic spacers (e.g., BGS-7).

Evidence summaryRCTs and systematic reviews show mixed results: some trials demonstrate noninferior fusion rates to autograft (limitations: intra-patient designs, heterogeneity); SiCaP pooled fusion ~93% in systematic review; longer-term and higher-quality trials needed.

inv-46: Definition — rhBMP-2 / Infuse (additional context)

DefinitionrhBMP-2 (recombinant human bone morphogenetic protein‑2): an osteoinductive growth factor that promotes differentiation of host mesenchymal stem cells into osteoblasts; when delivered via Infuse it is intended to achieve vertebral fusion and avoid autograft harvest.

Regulatory/indication noteInfuse is FDA-approved for specific lumbar (L2–S1) fusion indications when used with an appropriate interbody device; off‑label use (e.g., cervical fusion) has been associated with serious adverse events.

Evidence noteSystematic reviews include RCTs showing Infuse comparable to iliac crest bone graft for select lumbar fusions but overall trials have methodological limitations and variable follow-up.

inv-47: Definition — allograft / cell-based allograft

DefinitionAllograft / cell-based allograft: grafts derived from donated human bone that may be minimally processed to preserve cells (for example, PrimaGen, Osteocel) intended to provide bone-forming potential beyond standard allograft.

Evidence statusPublished evidence on cell‑containing allograft products is limited; ECRI assessments and small retrospective series do not establish comparative effectiveness versus autograft.

Policy stanceCell‑based allograft products and human amniotic tissue materials are considered unproven and not medically necessary due to insufficient evidence.

inv-48: Definition — Intra-patient (paired-side) design

DefinitionIntra-patient (paired-side) design: a clinical study design where each patient receives the experimental graft on one side/trajectory and the control (e.g., autograft) on the contralateral side, allowing paired comparison of radiographic fusion per side.

LimitationsThis design permits side-by-side fusion assessment but limits attribution of patient‑reported outcomes and adverse events to a specific graft because outcomes are measured at the patient level.

ImplicationResults demonstrating noninferiority in intra-patient trials may not translate directly to patient‑level clinical benefit without larger, patient‑oriented trials.

inv-49: Definition — SiCaP (silicate-substituted calcium phosphate)

DefinitionSiCaP (silicate-substituted calcium phosphate): a ceramic bone graft substitute in which calcium phosphate is substituted with silicate, reported across studies with a pooled mean fusion rate of approximately 93%.

Clinical findingsSystematic review (10 studies, 694 patients) reported mean fusion rate ~93% and improvements in VAS/ODI, but high heterogeneity limits certainty.

Use considerationsSiCaP has been evaluated as standalone and in combination with BMA/autograft across interbody and posterolateral procedures; further high‑quality trials are needed.

inv-50: Definition — Expandable interbody fusion system

DefinitionExpandable interbody fusion system: an interbody implant that can be expanded in situ to restore disc height and alignment and may include porous cavities for graft containment; designs vary and some systems have FDA 510(k) clearance or De Novo classification for lumbar indications.

Device examplesExamples in policy include Duo™ Ti, OptiMesh®, and other expandable devices; device-specific labeling and intended use should be confirmed.

Evidence stanceEvidence for many expandable systems is limited (predominantly retrospective, single‑center) and prospective RCTs with adequate sample size and patient‑oriented outcomes are lacking; policy considers many expandable systems unproven.

inv-51: Definition — rhBMP-2 general

DefinitionrhBMP-2 general: recombinant human bone morphogenetic protein‑2 is an osteoinductive protein used to stimulate bone formation and differentiation of host mesenchymal cells into osteoblasts when applied with an osteoconductive scaffold.

Therapeutic roleUsed as an adjunct or substitute for autograft in selected spinal fusion procedures; evidence includes RCTs in lumbar fusion showing comparable fusion to ICBG in some settings.

Safety/regulatory noterhBMP-2 has unique complication risks and is FDA‑approved for specified lumbar indications (Infuse); off‑label uses, notably cervical, have been associated with serious adverse events and warrant caution.

inv-52: Definition — Osseointegration (new)

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

RelevanceOsseointegration is a desired outcome for implants used in fusion procedures and is influenced by implant surface, design, and host bone biology.

Policy noteDefinition was added to the policy glossary in the recent revision to clarify implant‑bone integration terminology.

inv-53: Definition — Osteoconduction (new)

DefinitionOsteoconduction: the process by which bone grows on a surface (providing a scaffold for new bone formation).

MaterialsMany ceramic-based products and bioactive glass act primarily via osteoconduction as the scaffold for bone ingrowth.

Policy noteOsteoconduction definition was added to the policy glossary in the recent revision.

inv-54: Definition — Osteoinduction (new)

DefinitionOsteoinduction: the process by which osteogenesis is induced, recruiting immature cells and stimulating them to develop into preosteoblasts; a key mechanism in bone healing.

AgentsGrowth factors such as BMPs (including rhBMP-2) provide osteoinductive activity; some DBMs retain osteoinductive growth factors.

Policy noteOsteoinduction definition was added to the policy glossary in the recent revision.

inv-55: Definition updates — Allograft / Autograft / Bone Marrow Aspiration updated definitions referenced

Summary of updatesDefinitions for Allograft, Autograft, and Bone Marrow Aspiration were updated in the policy glossary per the 01/01/2026 revision.

Allograft updateClarified as transplant between individuals of same species with different genotype and noted examples such as DBM and structural allograft.

Autograft/BMA updateAutograft definition reaffirmed and Bone Marrow Aspiration definition clarified as removal of liquid marrow for examination or grafting; documentation expectations were added to policy.