CurrentUnitedHealthcarePolicy CSNCT0410.05

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

This UnitedHealthcare medical policy (North Carolina only) defines which bone grafts, biologics, and related devices are considered proven/medically necessary versus unproven/not medically necessary for spinal fusion and bone healing enhancement, and summarizes clinical evidence and applicable procedure codes referenced during utilization review.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSNCT0410.05

Change TypeMaterial and non-material edits (ceramic products declared not medically necessary; doc/definition updates)

Effective DateDec 1, 2025

Next Review Date

Key ActionMedical records must fully support medical necessity including relevant history, exam, and diagnostic test results; documentation may be required and claims may be denied if medical necessity is not supported.

POLICY UPDATE CHANGES

Added language to clarify Ceramic-Based Products (e.g., b-TCP, calcium phosphate, calcium sulfate) used alone or in combination with other grafts and/or graft components, including BMA, are unproven and not medically necessary.

Added language under Medical Records Documentation Used for Reviews specifying that benefit coverage is determined by federal/state/contractual requirements and that medical records documentation may be required and must fully support medical necessity.

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

Added notation that CPT codes 0814T, 20930, and 22899 are not on the NC Medicaid Fee Schedule and therefore may not be covered by NC Medicaid.

Updated Clinical Evidence and References sections to reflect current information.

6Unproven product categories

4Proven/medically necessary types

5Referenced CPT codes

mixedEvidence strength

limitedHigh‑quality RCTs

3NC Medicaid fee schedule notations

Coverage Summary

This UnitedHealthcare medical policy (North Carolina only) defines which bone grafts, biologics, and related devices are considered proven/medically necessary versus unproven/not medically necessary for spinal fusion and bone healing enhancement, and summarizes clinical evidence and applicable procedure codes used in utilization review.

The policy's overall coverage stance is mixed: some products and indications (e.g., autograft, selected DBM and allograft uses, InFUSE (rhBMP-2) for specified lumbar indications) are listed as proven/medically necessary when criteria are met, while other categories (including certain allograft cell-based products, bioactive glass, expandable interbody systems, and ceramic-based products) are identified as unproven and not medically necessary for the enhancement of spinal fusion.

Effective date: December 1, 2025. A material change in this revision explicitly clarifies that ceramic-based products (e.g., b-TCP, calcium phosphate, calcium sulfate) used alone or in combination with other grafts and/or graft components, including BMA, are unproven and not medically necessary.

High-level thresholds and quick facts

Age for Infuse (rhBMP-2) lumbar indication>= 18 years (or radiographic evidence of epiphyseal closure)

Age for InFUSE/MASTERGRAFT posterolateral revision device> 21 years (or radiographic evidence of epiphyseal closure)

Spondylolisthesis limit for Infuse lumbar useNo more than grade 1 (25% displacement)

Explicitly listed unproven product categories6

Material policy change (ceramic products declared not medically necessary)1

Referenced CPT codes noted as not on NC Medicaid fee schedule0814T, 20930, 22899

Medical-Necessity Criteria

Proven and Medically Necessary

Covered when ALL of the following are met:

ALL of the following

Autografts [including Bone Marrow Aspirate (BMA) used for bone grafting]
Demineralized Bone Matrix (DBM) without added products listed below as unproven and not medically necessary
Allograft-based products not listed below as unproven and not medically necessary
InFUSE Bone Graft (rhBMP-2) — Lumbar spine
- The approach is anterior or oblique and used in conjunction with an FDA-approved interbody fusion device

Evidence Summary and Policy Rationale

Evidence-based findings and implications

Summarized findings from systematic reviews, randomized controlled trials, and evidence assessments:

ALL of the following

rhBMP-2 (recombinant BMP) compared to iliac crest bone graft (ICBG) provides more rapid fusion and higher fusion rates in lumbar fusion trials but does not consistently yield improved pain, disability, or quality of life; short-term safety appears reasonable but long-term risks (including potential cancer risk) remain uncertain
rhBMP-2 evidence for cervical fusion shows increased adverse events in some studies and FDA public health notification (2008) regarding life-threatening complications for cervical use; safety and effectiveness for thoracic fusion insufficient
Ceramic-based products: evidence is mixed — several RCTs and intra-patient noninferiority trials (AttraX Putty, MagnetOs Granules, CBGS, iFactor) show noninferiority or similar fusion rates compared with autograft in certain settings (PLF, XLIF, PLIF), but heterogeneity, small samples, sponsorship bias, and limited long-term data limit certainty

Professional Society Recommendations & Regulatory Notes

AANS (2014) guidance: DBM can be used as a bone graft extender for 1- and 2-level instrumented posterolateral fusions; b-TCP/local autograft may be an option as a substitute for iliac crest autograft in single-level instrumented posterolateral fusion. Hydroxyapatite (HA) with local autograft/BMA can be considered as a substitute or extender in instrumented posterolateral fusion, with insufficient evidence for some HA combinations.

AANS notes rhBMP-2 is associated with unique complications and may be an option as an autograft substitute in certain interbody approaches (e.g., ALIF with threaded cages, single-level PLIF) and as a graft extender in TLIF with structural interbody graft, while some standalone or supplemental uses lack sufficient evidence.

NASS (2014, 2017) supports structural allograft for multiple anterior cervical reconstruction scenarios and posterior cervical fusion; DBM combined with autograft is indicated for posterior instrumented fusion but not supported as standalone in non-instrumented posterior or anterior fusions. NASS also outlines selective adjunctive roles for rhBMP-2 in high-risk nonunion scenarios and advises against routine cervical or single-level posterior/posterolateral use in healthy adults.

Allografts are regulated as HCT/Ps; if combined with other materials the resulting product may be regulated as a medical device.

Examples of FDA device/clearances noted in the policy include: Bicera (510(k) K172237), InFUSE Bone Graft/LT-CAGE (PMA P000058 and supplements), i-FACTOR (PMA, 2015), OptiMesh (510(k) K014200; de novo DEN200010 for expanded indications), and the Duo Expandable Interbody Fusion System (510(k) K210155).

Indication note: the Duo Expandable Interbody Fusion System is approved for fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 for degenerative disc disease with up to Grade I spondylolisthesis at the involved level.

Provider Actions and Utilization Management

Prior Authorization

InFUSE lumbar and InFUSE/MASTERGRAFT posterolateral revision device use

InFUSE lumbar and InFUSE/MASTERGRAFT posterolateral revision device use must conform to FDA-approved indications and the clinical criteria below. Prior authorization may be required when applicable per plan rules.

Approach: InFUSE for lumbar spine limited to anterior or oblique approach used with an FDA‑approved interbody fusion device; InFUSE/MASTERGRAFT posterolateral revision device implanted via a posterolateral approach.
Levels: InFUSE lumbar use limited to vertebral bodies L2–S1; InFUSE lumbar approved for single‑level fusion only.
Age: Skeletally mature individuals — InFUSE lumbar: ≥18 years (or radiographic evidence of epiphyseal closure); InFUSE/MASTERGRAFT posterolateral revision device: >21 years (or radiographic evidence of epiphyseal closure).
Spondylolisthesis: For InFUSE lumbar, spondylolisthesis no greater than grade 1 (≤25% displacement) at the involved level.
Other: Use must follow all FDA indications, contraindications, warnings, and precautions; documentation must demonstrate the specific device/product used and clinical rationale.

Coding

Referenced 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 - Notation / State-specific exclusionCPT

0814T	Not on the State of North Carolina Medicaid Fee Schedule (may not be covered by NC Medicaid)
20930	Not on the State of North Carolina Medicaid Fee Schedule (may not be covered by NC Medicaid)
22899	Not on the State of North Carolina Medicaid Fee Schedule (may not be covered by NC Medicaid)

The policy adds a 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 NC Medicaid. Providers should verify state-specific coverage and fee-schedule rules prior to billing or treatment authorization.

Definitions

Term	Definition
Allograft
The transplant of an organ or tissue from one individual to another of the same species with a different genotype. Also known as an allogeneic graft or a homograft; updated definition in policy (see policy for full updated text).
Autograft
Tissue grafted into a new position in the body of the same individual; updated definition in policy (see policy for full updated text).
DBM (Demineralized Bone Matrix)
An allograft produced by dissolving the mineralized portion of bone leaving the collagen matrix and retained growth factors; the collagen matrix provides weak osteoconductive capacity and DBM must be combined with a carrier that serves as an osteoconductive scaffold.
InFUSE (rhBMP-2)
Absorbable collagen sponge coated in recombinant human bone morphogenetic protein-2 approved for certain spinal fusion indications (L2-S1).
BMA (Bone Marrow Aspiration)
Removal of bone marrow in liquid form used for grafting; updated definition in policy (see policy for full updated text).
ICBG
Iliac Crest Bone Graft (autograft harvested from the patient's iliac crest).
PLF
Posterolateral fusion.
PLIF/TLIF/ALIF/XLIF
Posterior/Transforaminal/Anterior/Lateral lumbar interbody fusion approaches.
Osseointegration
The stable anchorage of an implant achieved by direct bone-to-implant contact.
Osteoconduction
Process by which bone grows on the surface (provides a scaffold for bone growth).
Osteoinduction
The process by which osteogenesis is induced by recruitment and stimulation of immature cells to develop into preosteoblasts; a key mechanism in bone healing.

Evidence & References

The evidence base cited in the policy includes systematic reviews, ECRI clinical evidence assessments, randomized controlled trials (including intra-patient noninferiority RCTs), prospective and retrospective cohort studies, and device assessments. Study quality and designs are heterogeneous across products.

Overall conclusions emphasize that high-quality randomized evidence is limited, findings are often mixed or inconsistent across outcomes (radiographic fusion versus patient-reported outcomes), and long-term safety and efficacy data are frequently lacking, leading to uncertainty for many biologic and synthetic bone graft substitutes.

Study / Source	Key finding
Fitzgerald 2025
Systematic review found A1 evidence supporting Infuse for adults with DDD L2-S1 in lumbar interbody fusion; overall lack of high-quality comparative trials for other products.
ECRI assessments (2016-2024)
Multiple ECRI reviews concluded evidence for many cellular/allograft and synthetic products is very low quality and inconclusive; specific assessments for MagnetOs and Bicera noted limited or no data.
MagnetOs RCT (Stempels et al. 2024)
Intra-patient RCT showed noninferiority and higher fusion rate for biphasic calcium phosphate granules vs autograft in PLF at 1 year; limitations include intra-patient design and uncertain long-term clinical significance.
AttraX Putty RCT (Lehr et al. 2020)
Intra-patient randomized noninferiority trial showed similar fusion rates for AttraX Putty vs autograft in thoracolumbar PLF at 1 and 2 years; intra-patient design limits attribution of PROMs and long-term conclusions.
iFactor evidence (Hasan et al. 2024; ECRI/i-Factor assessments)
Systematic reviews report faster bone development and similar PROs for iFactor/ABM/P-15 but studies are limited, often industry-sponsored, and more RCTs are ongoing or needed.
Bioactive glass evidence
Retrospective series and small RCTs report promising radiographic fusion and PRO improvements but ECRI assessment: insufficient/very-low quality evidence to determine equivalence to ICBG.
Expandable cages evidence (Lee et al. 2023)
Systematic review/meta-analysis (13 studies, 1700 patients) found increased anterior disc height and segmental lordosis with expandable vs static cages but no differences in clinical outcomes; overall low-level evidence and heterogeneity.
Lee et al. 2023 (expandable cages) - retrospective/cohort studies
Retrospective studies report radiographic and some PRO improvements with expandable devices but quality is low and larger RCTs are needed.
Kucharzyk & Miller 2020
Retrospective single-center study (50 patients) reported substantial improvements in ODI, back and leg pain and 98% fusion at 2 years with a multidimensional expandable implant; limited by lack of comparator and retrospective design.

Revision History

12/01/2025material_changeLatest

Added language clarifying 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.

12/01/2025added

12/01/2025

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSNCT0410.05

Change TypeMaterial and non-material edits (ceramic products declared not medically necessary; doc/definition updates)

Effective DateDec 1, 2025

Next Review Date

On This Page

Skeletally mature individual (18 years of age or older or radiographic evidence of epiphyseal closure) with degenerative disc disease (DDD)

The fusion involves vertebral bodies L2-S1, without or with spondylolisthesis of no more than grade 1 (25% displacement) at the involved levelL2-S1

The fusion is single levelsingle level

InFUSE/MASTERGRAFT Posterolateral Revision Device

Implanted via a posterolateral approach
Presence of symptomatic posterolateral lumbar spine pseudoarthrosis
Skeletally mature patient (older than 21 years of age or radiographic evidence of epiphyseal closure)>21 years
Autologous bone and/or bone marrow harvest is not feasible or is not expected to promote fusion

ALL of the following

Ceramic-Based Products Coverage Rationale: Policy history reflects a change clarifying that 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 considered unproven and not medically necessary due to insufficient evidence of efficacy and safety.
Evidence Summary for Expandable Interbody Fusion Systems: Current evidence, including device descriptions (e.g., Duo™ Ti, OptiMesh®, other expandable interbody systems), is limited in quality and quantity. Published studies are insufficient to demonstrate long-term clinical benefit or superiority versus standard interbody fusion devices; therefore expandable interbody fusion systems are considered unproven and not medically necessary for enhancement of spinal fusion.
Society Recommendations (AANS, NASS) — Osteobiologics and rhBMP-2: Professional society guidance notes cautious use of osteobiologics. Recommendations emphasize use of rhBMP-2 (InFUSE) only for FDA-labeled indications and patient populations, and advise against off-label posterolateral use except where specifically approved (e.g., InFUSE/MASTERGRAFT Posterolateral Revision Device under its FDA indication). Societies recommend consideration of risks (including ectopic bone formation and inflammation) and patient-specific factors when using rhBMP-2.
FDA Device Approvals / Regulatory Notes (Informational): InFUSE™ Bone Graft is FDA-approved for certain spine, dental, and trauma indications and should be used consistent with FDA-labeled indications, contraindications, warnings, and precautions. The Duo™ Ti and OptiMesh® devices have FDA regulatory summaries describing intended use as interbody fusion implants; clinicians should consult FDA 510(k)/PMA summaries and device labeling for specific indications and limitations. This section is informational and does not alter coverage criteria.

Unproven and Not Medically Necessary

Not covered (considered unproven and not medically necessary) when ALL of the following are met:

ALL of the following

Allograft-based products: Cell-based (e.g., mesenchymal stem cells [MSC])
Allograft-based products: Human amniotic tissue materials, including amniotic fluid stem cell substitutes
Recombinant human bone morphogenetic protein-2 (e.g., rhBMP-2, InFUSE) and InFUSE/MASTERGRAFT (or InFUSE BMP used with Mastergraft or Mastergraft alone) Posterolateral Revision Device for all other indications not included in the Proven and Medically Necessary criteria above
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)
Bioactive Glass used alone or in combination with other grafts including Bone Marrow Aspirate (BMA)
Expandable Interbody Fusion System

Specific ceramic products have limited or low-quality evidence (e.g., MagnetOs EasyPack Putty: no data identified by ECRI; Bicera: limited nonrandomized/case series evidence; i-Factor: limited evidence, ongoing trials expected)

Bioactive glass: preliminary studies and ECRI assessment indicate insufficient/very-low quality evidence to determine equivalence to ICBG; some single-center or retrospective series report promising radiographic fusion and PRO improvements but limited by design and sample size

Expandable interbody fusion systems: unproven due to lack of prospective RCTs with larger sample sizes and long-term follow-up; existing evidence from retrospective cohorts and systematic reviews is low-quality and heterogeneous

Autologous iliac crest bone graft (ICBG) is considered the gold standard for spinal fusion because it provides osteoconductive, osteoinductive, and osteogenic properties but is associated with donor site morbidity.

Biological products such as Bone Marrow Aspirate (BMA), recombinant human bone morphogenetic protein-2 (rhBMP-2), and Demineralized Bone Matrix (DBM) may improve fusion success; many other biologic and synthetic products (e.g., human amniotic derivatives, cell-based allografts, ceramic-based products, bioactive glass) are under investigation but supported by limited high-quality evidence.

Policy History change effective 12/01/2025: the policy was revised to state that 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 for enhancement of spinal fusion.

Key evidence highlights

Fitzgerald 2025 systematic review - Infuse evidenceA1-level evidence supports InFUSE for adults with DDD L2-S1 in lumbar interbody fusion; overall comparative evidence for other products limited

ECRI assessmentsMultiple ECRI reviews (2016–2024) conclude many cellular/allograft and synthetic bone graft products have very low-quality or inconclusive evidence

rhBMP-2 vs ICBG outcomesConsistently faster and higher fusion rates with rhBMP-2 versus ICBG, but inconsistent pain/disability benefit and uncertain long-term risks

rhBMP-2 safety signalsReported postoperative inflammation, ectopic bone, osteoclast resorption, adipogenesis; FDA 2008 warning for cervical use

MagnetOs and AttraX RCT findingsMagnetOs Granules (Stempels 2024) intra-patient RCT showed noninferiority (and higher fusion side rates) vs autograft in PLF; AttraX Putty RCT (Lehr 2020) demonstrated noninferiority vs autograft in thoracolumbar PLF

iFactor/ABM/P-15 evidenceSystematic reviews report faster bone development and similar PROs but limited studies and sponsorship bias; more trials pending

Expandable cages evidence (Lee 2023)& othersMeta-analysis (Lee 2023) of 13 studies: increased anterior disc height and segmental lordosis but no clear clinical benefit; overall evidence low-quality and heterogeneous

Documentation Required

Medical records documentation requirement

Medical records must fully support the medical necessity for the requested services. Records should be legible, maintained in the patient's medical record, and provided upon request.

History: Relevant clinical history including symptoms, conservative therapy attempted and duration, prior surgeries.
Physical examination: Findings that correlate with the surgical indication.
Diagnostics: Pertinent imaging reports (e.g., MRI, CT, X‑ray) and test results supporting the indication and targeted fusion levels.
Operative reports and implant logs: Documentation of the device/product used, levels fused, approach, and intraoperative findings.
Prior grafts: Documentation of prior autograft harvest/use or rationale for not using autograft when applicable.

Documentation Required

Use evidence‑based indication and document rationale

Document the specific product used and the clinical justification for its use. When using rhBMP‑2 (InFUSE), ceramic substitutes, bioactive glass, or expandable systems, include the rationale, fusion level(s), fusion type, and prior autograft use.

Specify exact product name and manufacturer.
State the indication and justification for using rhBMP‑2 or alternative graft substitutes (e.g., autograft infeasible, revision pseudoarthrosis).
Record fusion level(s) and type (interbody, posterolateral, etc.) and whether autologous bone or BMA was attempted or not feasible.
If using novel or less‑established products, provide supporting evidence or rationale in the medical record.

Prior Authorization

Prior authorization recommended for off‑label or higher‑risk uses

Prior authorization may be required for off‑label or higher‑risk uses. Providers should seek PA when planning thoracic or cervical rhBMP‑2 use, off‑label indications, or when proposing novel devices or techniques that lack robust randomized controlled trial data.

Off‑label rhBMP‑2 use (e.g., thoracic or cervical applications).
Use of rhBMP‑2 or InFUSE for indications outside FDA approvals or for multi‑level lumbar applications beyond single level L2–S1 authorization.
Novel devices or expandable systems without strong RCT evidence — payer may require PA and supporting clinical documentation.

Denial Risk

Potential denial for insufficient evidence uses

Claims may be denied if documentation does not support medical necessity or the product/indication is not covered under the plan or applicable law.

Insufficient or illegible medical record documentation to justify the requested service.
Use of products or indications listed as unproven and not medically necessary in this policy (e.g., ceramic‑only grafts, bioactive glass alone, cell‑based allografts for fusion, rhBMP‑2 or InFUSE/MASTERGRAFT for indications not included as proven).
Requests inconsistent with FDA‑approved indications when the plan does not cover off‑label use.

Prior Authorization

Confirm benefit coverage and contractual requirements

Confirm benefit coverage and contractual requirements prior to service. Benefit coverage is determined by federal, state, and contractual plan rules, which may vary by member. Payers may use third‑party tools or clinical review processes to adjudicate coverage.

Verify member benefits, prior authorization rules, and any state‑specific mandates before scheduling procedures.
Be aware that some CPT/HCPCS codes may be excluded from certain state Medicaid fee schedules.
Provide requested medical records promptly to facilitate timely review.

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

12/01/2025added

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 NC Medicaid.

12/01/2025revised

Updated Clinical Evidence and References sections to reflect current information (systematic reviews, ECRI assessments, and recent trials and device approvals updated).