ModifiedUnitedHealthcarePolicy CSNCT0410.05

Spinal Fusion and Bone Healing Enhancement Products (for North Carolina Only)

Defines medical necessity and noncoverage determinations for spinal fusion bone grafts and adjunctive products used to enhance fusion in North Carolina members covered by UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

PolicySpinal Fusion and Bone Healing Enhancement Products (for North Carolina Only)

Policy CodePolicy CSNCT0410.05

Change TypeCoverage rationale updatedceramic-based products classified as unproven/not medically necessary

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionDocument and submit medical records that fully support medical necessity when requesting coverage for osteobiologic products; note some products may be denied.

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 notation that CPT codes 0814T, 20930, and 22899 are not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program.

Added medical records documentation language describing documentation that may be required to assess medical necessity.

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

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

NCApplies to

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.

Coverage Criteria and Policy Rationale

InFUSE (rhBMP-2) lumbar interbody — covered indications

Proven and medically necessary when ALL applicable conditions are met

InFUSE lumbar interbody indications: InFUSE Bone Graft (rhBMP-2) is covered for lumbar spine when: the approach is anterior or oblique and used in conjunction with an FDA‑approved interbody fusion device; the patient is skeletally mature (18 years of age or older or radiographic evidence of epiphyseal closure) with degenerative disc disease (DDD); the 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 — covered indications

Proven and medically necessary when ALL applicable conditions are met

InFUSE/MASTERGRAFT Posterolateral Revision Device System: Covered when used according to FDA indications, contraindications, warnings, and precautions in patients who meet all of the following: implanted via a posterolateral approach; presence of symptomatic posterolateral lumbar pseudoarthrosis; skeletally mature (older than 21 years or radiographic evidence of epiphyseal closure); and autologous bone and/or bone marrow harvest is not feasible or is not expected to promote fusion.

Autograft, DBM, and other allografts

Proven and medically necessary (general)

Other proven grafts: Autografts, including bone marrow aspirate (BMA), are considered the standard and are proven/medically necessary for spinal fusion. Demineralized bone matrix (DBM) products without added items listed as unproven are considered medically necessary. Structural and nonstructural allograft products not specifically listed as unproven are considered medically necessary when used consistent with accepted indications (for example, structural allograft for anterior cervical reconstruction and other scenarios per specialty guidance).

Evidence-based coverage considerations

Coverage stance and evidence summaries by product class

Allograft and cell-based products: Evidence is limited in quality and quantity for many marketed allograft and cell-based products (e.g., PrimaGen, OsteoAMP, OsteoCel); published studies are often single-arm or retrospective and generally do not provide comparative data to autograft. Further large prospective, randomized studies are needed.

Human amniotic tissue: Limited evidence exists in human models that amniotic tissue improves outcomes in lumbar fusion; long-term safety and efficacy have not been established.

rhBMP-2 / recombinant BMPs: rhBMP-2 (InFUSE) increases fusion rates in lumbar fusion but is associated with higher adverse event rates in some settings; Infuse is FDA‑approved only for L2–S1 lumbar fusion. Off‑label cervical use has documented life‑threatening adverse events and FDA warnings. High‑quality comparative trials are limited and risks and benefits must be balanced.

Ceramic-based and other synthetic products:

Evidence-based coverage considerations

Coverage considerations based on available evidence and study limitations

General evidentiary requirements

Current evidence limitations: Existing studies are often single‑center, small sample sizes, heterogeneous procedures, industry‑sponsored, use intra‑patient designs limiting attribution of clinical outcomes, and rely on CT/imaging assessments with variable reliability.

Products with some supportive but limited evidence: Some products (for example, iFactor/P‑15, SiCaP, AttraX Putty, MagnetOs Granules, CBGS, BGS‑7, BioSphere/bioactive glass) have studies reporting comparable or favorable fusion rates versus autograft or controls, but limitations in study design and consistency mean equivalence or broad superiority is not established.

Coverage-relevant evidence summaries and society recommendations

Coverage-relevant findings and society guidance present in the document excerpts:

Bioactive glass clinical evidence: Small studies and case series (e.g., BGS‑7 spacer comparisons, BioSphere Putty retrospective series) report similar fusion rates and clinical outcomes to autograft in selected procedures, but limitations include retrospective design, small samples, short follow‑up, and risk of bias; further high‑quality research is needed.

Expandable interbody fusion systems evidence: Systematic reviews and observational studies show mixed results: expandable cages may improve certain radiographic parameters (disc height, segmental lordosis) but do not demonstrate consistent clinical benefit over static cages; evidence quality is low and prospective RCTs are needed.

ECRI rated very low‑quality evidence for some patient‑specific implants (Aprevo).

Hydroxyapatite and calcium extenders: Hydroxyapatite (HA) used with local autograft/BMA can be an option as a graft extender or substitute in certain single‑level instrumented posterolateral fusions; evidence is insufficient for HA‑glass/BMA composites.

Unproven / Not Medically Necessary - Ceramic-Based Products

Policy-level coverage stance added for ceramic-based products

Ceramic-based products: Ceramic‑Based Products (for example, 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 to Coverage Rationale on 12/01/2025

Allograft-based cell products (for example, products that include viable mesenchymal stem cells or other native bone cells) and related human amniotic tissue materials are classified as unproven and not medically necessary due to insufficient high-quality clinical evidence to determine safety and efficacy. The literature is limited to small cohort trials, often with short follow-up, risk of sponsor bias, and lacks adequate comparative data versus autograft; therefore larger prospective randomized studies are needed to substantiate clinical benefit.

Off-label use of recombinant human bone morphogenetic protein-2 (rhBMP-2, e.g., InFUSE) in the cervical spine has been associated with life‑threatening adverse events (including airway and neurologic compression) and has prompted FDA warnings. Although rhBMP-2 increases fusion rates in some settings, the balance of higher adverse event rates reported for cervical applications means safety and effectiveness are not established for off‑label cervical indications; such use requires careful risk–benefit justification and may be denied.

The ECRI assessment identified no published clinical data to inform the safety or effectiveness of MagnetOs EasyPack Putty for lumbar fusion. Because relevant clinical studies published as full articles were not found, MagnetOs EasyPack Putty is considered unproven for lumbar fusion until higher‑quality evidence is available.

Several specific products and product classes are considered experimental or investigational due to inadequate clinical evidence. This includes cell‑based allograft products, certain ceramic‑based products, MagnetOs EasyPack Putty per the ECRI assessment, bioactive glass formulations without robust comparative data, and expandable interbody fusion systems when evidence is insufficient to determine clinical benefit. Use of these products may be excluded from coverage until stronger, comparative clinical data are available.

The North American Spine Society (NASS) guidance advises against routine use of rhBMP‑2 for anterior and posterior cervical fusion procedures and for routine pediatric spine fusions; it recommends rhBMP‑2 as an adjunct only in selected high‑risk situations. NASS emphasizes limiting rhBMP‑2 use to indications and patient groups in which benefits outweigh known risks.

Per the Coverage Rationale, 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 explicitly classified as unproven and not medically necessary because current evidence does not establish safety and efficacy for these uses.

Cell‑based allograft products and many recently introduced allograft or synthetic bone graft products lack sufficient high‑quality clinical evidence to establish comparative effectiveness versus autograft. Published studies are commonly single‑arm or retrospective, frequently manufacturer‑sponsored, and do not provide robust comparative outcomes; therefore these products are considered not medically necessary for routine fusion indications until better evidence is available.

The policy lists multiple products and indications for which human clinical evidence is insufficient to determine improved health outcomes. This encompasses many ceramic‑based products and some bioactive glass formulations where heterogeneity of composition and a lack of well‑designed comparative trials prevent generalization of results; use of these materials may be considered investigational or not medically necessary.

Where the policy explicitly states that evidence is insufficient (for example, many ceramic‑based substitutes and certain bioactive glass products), those products are treated as not medically necessary or investigational. The document calls for well‑designed randomized trials, standardized fusion assessment (e.g., CT at defined timepoints), and longer‑term safety data to change these determinations.

Expandable interbody fusion systems are described as unproven because the available evidence is low quality: prospective randomized controlled trials with adequate sample sizes and longer follow‑up are lacking. Systematic reviews and cohort studies report mixed radiographic findings and inconsistent clinical benefit versus static cages, and some device‑specific assessments (e.g., Aprevo) were judged to have very low‑quality data.

Ceramic‑based products used alone or in combination with other graft materials (including with BMA) are classified in the policy as unproven and not medically necessary. The policy highlights wide product heterogeneity and insufficient comparative clinical data as the basis for this coverage stance.

Procedure and Billing Codes

Reference 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

Applicable Codes - NC Medicaid fee schedule noteCPT

0814T	CPT code noted as not on the State of North Carolina Medicaid Fee Schedule
20930	CPT code noted as not on the State of North Carolina Medicaid Fee Schedule
22899	CPT code noted as not on the State of North Carolina Medicaid Fee Schedule

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required — Off‑Label rhBMP-2 (Cervical)

Prior authorization required for off-label cervical use of rhBMP-2 (InFUSE) due to safety concerns and FDA warnings; documentation must justify off-label indication and risk/benefit assessment.

Prior authorization required for InFUSE (rhBMP-2) when used for cervical fusion (off‑label).
Include clinical rationale, prior treatments, and why autograft/other alternatives are not suitable.
Document informed consent discussing airway/neurologic compression and other potential life‑threatening AEs.

Denial Risk

Safety Concern — rhBMP-2 Cervical Use

rhBMP-2 (InFUSE) cervical use has documented higher rates of adverse events and has prompted FDA warnings; off‑label cervical application may result in denial absent strong clinical justification and complete documentation.

Clinical Background and Rationale

Autologous iliac crest bone graft (ICBG) has historically been considered the gold standard for spinal fusion because it provides osteoconductive, osteoinductive, and osteogenic properties. Although effective, ICBG harvest is associated with donor‑site morbidity, which has driven interest in biologic adjuncts and graft substitutes; however, many newer products do not yet have sufficient high‑quality evidence to replace autograft routinely.

Definitions and Regulatory Context

Allograft definition

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).

Typical useDonor-derived bone used as morselized, structural, or processed products (e.g., DBM) in spinal fusion procedures.

Regulatory noteWhen combined with other materials the resulting product may be regulated by the FDA as a device; minimally manipulated human bone is considered an HCT/P.

Autograft definition

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

Common sourceIliac crest bone graft (autologous iliac crest bone) historically considered the gold standard for spinal fusion due to osteoconductive, osteoinductive, and osteogenic properties.

Clinical Evidence, Systematic Reviews and References

21Studies in Fitzgerald 2025 review

3Infuse RCTs cited in Fitzgerald review

20RCTs in Liu et al. meta-analysis

1Material policy change effective 12/01/2025

Evidence summaries and society recommendations cited in the policy emphasize mixed and generally limited quality data across osteobiologic classes. Small comparative studies and retrospective series report promising fusion rates for some products (bioactive glass, certain ceramics, or expandable devices), but systematic reviews repeatedly call for adequately powered randomized trials, standardized radiographic fusion assessment, and longer follow‑up. Specialty society guidance (AANS, NASS) supports selective use of alternatives to autograft in defined scenarios but cautions against routine use of some agents (for example, routine cervical rhBMP‑2).

Policy Revision History

2025-12-01coverage_rationale_updateLatest

Added language classifying ceramic-based products (e.g., b-TCP, calcium phosphate, calcium sulfate) used alone or with other grafts and/or graft components, including bone marrow aspirate (BMA), as unproven and not medically necessary.

2025-12-01documentation_update

Added medical records documentation language clarifying that records may be required to assess clinical criteria for coverage and listing required elements (history, exam, diagnostic tests) but do not guarantee coverage.

2025-12-01definitions_update

Policy Summary

PayerUnitedHealthcare

PolicySpinal Fusion and Bone Healing Enhancement Products (for North Carolina Only)

Policy CodePolicy CSNCT0410.05

Change TypeCoverage rationale updatedceramic-based products classified as unproven/not medically necessary

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionDocument and submit medical records that fully support medical necessity when requesting coverage for osteobiologic products; note some products may be denied.

SourceLink

On This Page

Denial Risk

Denial Risk — Ceramic‑Based Products

Ceramic‑based products (e.g., b‑TCP, calcium phosphate, calcium sulfate) are considered unproven and not medically necessary for spinal fusion when used alone or combined with graft components; use may be denied without clear, supporting evidence.

Denial likely for use of ceramic-based products as standalone graft substitutes or in combination with BMA unless high‑quality, procedure-specific evidence is provided.
If requesting coverage, submit clinical justification and comparative evidence versus autograft/standard of care.

Documentation Required

Documentation Required — Medical Records and Justification

Medical records must fully support medical necessity for requests that deviate from FDA‑approved indications (including off‑label rhBMP-2 cervical use) or seek coverage for unproven products; documentation does not guarantee approval.

Include relevant history, physical exam, diagnostic tests, prior conservative treatments, and prior graft attempts if applicable.
For off‑label rhBMP-2 cervical requests, include informed consent discussion, alternative options considered (e.g., autograft), and explicit risk/benefit rationale.
For ceramic-based or other unproven products, include procedure‑specific evidence and justification comparing expected outcomes to standard therapies.

BMP / rhBMP definition

DefinitionBMP / rhBMP: Bone Morphogenetic Proteins are naturally occurring osteoinductive proteins that stimulate differentiation of local mesenchymal stem cells into osteoblasts; recombinant human BMP (rhBMP) is produced via recombinant DNA techniques.

MechanismOsteoinductive growth factors applied to osteoconductive implants to promote vertebral fusion by stimulating natural bone formation.

Clinical cautionrhBMP-2 (Infuse) is associated with increased fusion rates in some settings but also higher adverse event rates in others; risks and benefits must be balanced.

BMP / rhBMP definition

DefinitionInFUSE (Infuse) Bone Graft: A bone graft product that contains rhBMP-2 delivered on an absorbable collagen sponge; approved for specified spine, dental, and trauma indications and FDA-approved for lumbosacral fusion (L2–S1).

Intended useUsed instead of autologous bone graft alongside an interbody fusion cage for approved lumbar indications to promote vertebral fusion.

Regulatory historyInFUSE/LT-CAGE received FDA approvals and supplements (PMA/510(k) history cited); Infuse is the only FDA-approved spinal fusion product containing rhBMP-2 for L2–S1 use in the U.S.

InFUSE definition

Device/ProductInFUSE (Infuse) Bone Graft: contains rhBMP-2 on an absorbable collagen sponge and is approved for certain spine, dental, and trauma indications.

Specific approvalFDA granted clearance/approval for InFUSE/LT-CAGE (multiple supplements) and InFUSE/MASTERGRAFT was granted a Humanitarian Device Exemption in 2008 for specific posterolateral revision use.

Clinical noteInfuse is approved only for specified lumbar indications; off-label use (e.g., cervical fusion) has been associated with life‑threatening adverse events and FDA warnings.

Expandable Interbody Fusion Systems definition

DefinitionExpandable Interbody Fusion Systems: Implants designed to provide mechanical support of the intradiscal space and to contain graft material, expanding in situ to create an anatomy-conforming interbody implant (examples: Duo Ti, OptiMesh, Duo™ Expandable systems).

Intended functionProvide graft containment, restore disc height and segmental lordosis, and act as adjuncts to fusion with porous cavities for graft material.

Evidence statusEvidence is limited; systematic reviews report mixed results and a lack of high-quality RCTs to demonstrate consistent clinical benefit over static cages.

rhBMP-2 / Infuse note

NoterhBMP-2 (Infuse) is FDA‑approved for lumbar lumbosacral fusion (L2–S1) and can increase fusion rates, but its use is associated with higher adverse event rates in some settings; off-label cervical use has documented life‑threatening adverse events and FDA warnings.

Coverage contextInfuse is covered for single-level L2–S1 anterior/oblique interbody fusion with an FDA‑approved device when all criteria are met; other uses may be unproven or not medically necessary.

Provider actionOff‑label cervical use may require prior authorization and clear risk–benefit justification due to safety concerns and FDA warnings.

Allograft / cell-based allograft note

NoteAllograft and cell‑based allograft products (e.g., PrimaGen, OsteoAMP, Osteocel) are derived from donor bone and may be minimally processed or include viable cells; published evidence is limited in quality and quantity and often lacks comparative data to autograft.

Evidence implicationMany studies are single‑arm or retrospective; larger prospective randomized studies comparing these products to autograft are needed to establish comparative effectiveness.

Coverage impactSome allograft products not specifically listed as unproven are considered proven/medically necessary when used per policy; cell‑based/allograft products listed as unproven may be excluded.

Ceramic-based products definition

DefinitionCeramic-based products: Mineral salts (e.g., hydroxyapatite, calcium phosphate, tricalcium phosphate, calcium sulfate) produced at high temperatures to create osteoconductive structures used as synthetic bone graft substitutes.

CharacteristicsProduct heterogeneity in composition, manufacturing, porosity, and structure affects clinical outcomes and limits generalization across products.

Policy stanceThe policy classifies many ceramic‑based products as unproven due to insufficient evidence; MagnetOs EasyPack Putty had no identified clinical data for lumbar fusion per ECRI.

Bioactive glass definition

DefinitionBioactive glass: Synthetic silica‑based materials (typical oxides: SiO2, CaO, Na2O, P2O5) introduced as bone graft substitutes that bond to bone and are claimed to promote hydroxyl carbonated apatite (HCA) formation and high osteoconductivity.

Evidence statusSmall studies and case series report similar fusion rates to autograft in limited cohorts, but overall high‑quality evidence is insufficient to draw firm conclusions on safety and efficacy.

Clinical claimManufacturers claim faster HCA and bone bonding formation compared with other synthetic ceramics, but comparative effectiveness remains unestablished.

Allograft / HCT/P note

NoteAllografts are regulated as human cells, tissues, and cellular and tissue‑based products (HCT/P) when minimally manipulated human bone is used for transplantation; if combined with other materials the resulting product may be regulated by the FDA as a device.

Regulatory implicationProviders and payers should reference FDA guidance for specific product classification and regulatory status when assessing products for coverage.

ReferenceFDA resources and device listings (PMN/510(k)/PMA/HDE databases) may be used to verify regulatory designations for specific graft products.