CurrentColorado Rocky Mountain Health PlansPolicy CS009.V

Spinal Fusion and Bone Healing Enhancement Products

Defines medical necessity and exclusions for autografts, allografts, demineralized bone matrix (DBM), recombinant human bone morphogenetic protein-2 (rhBMP-2 / InFUSE), InFUSE/MASTERGRAFT system, and various allograft/cell-based/ceramic/bioactive glass products for spinal fusion procedures; includes applicable CPT/HCPCS procedure codes for reference.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySpinal Fusion and Bone Healing Enhancement Products

Policy CodePolicy CS009.V

Change TypeCoverage Rationale update (12/01/2025) + template edits

Effective DateDec 1, 2025

Next Review Date

Key ActionDocument indication, levels fused, device/product used, and provide clinical justification and supporting literature; medical records may be required and prior authorization is recommended for off-label or novel products.

POLICY UPDATE CHANGES

Template update removed content/language pertaining to the state of Louisiana.

Added language clarifying Ceramic-Based Products used alone or in combination with other grafts and/or BMA are unproven and not medically necessary.

Added medical records documentation language clarifying benefit coverage is determined by federal/state/contractual requirements and that documentation may be required for review.

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

1Policy Part Number (this part)

>6Product categories discussed

mixedDefinitive Superiority to ICBG

Coverage summary

Policy CS009.V (effective December 1, 2025) defines medical necessity and exclusions for a range of spinal fusion and bone‑healing enhancement products, including autografts, allografts, DBM, rhBMP‑2 (InFUSE), InFUSE/MASTERGRAFT, and various allograft/cell‑based, ceramic, bioactive glass, and expandable interbody systems. The policy stance is mixed: specific products and indications are designated as proven and medically necessary when listed clinical criteria are met, while several product classes are listed as unproven and not medically necessary due to insufficient evidence of efficacy and/or safety. Covered product classes include autografts (including BMA), DBM (when not combined with products designated unproven), and certain allograft‑based products and FDA‑indicated uses of InFUSE/InFUSE‑MASTERGRAFT per the stated criteria; not‑covered classes include various allograft cell‑based products, human amniotic tissue materials, most uses of rhBMP‑2/InFUSE outside the covered indications, Ceramic‑Based Products used alone or in combination with other grafts and/or BMA, bioactive glass used alone or with BMA, and expandable interbody fusion systems. The policy summarizes evidence limitations and guidance for documentation and prior authorization.

Key clinical thresholds

Spondylolisthesis displacement limitNo more than grade 1 (25% displacement) at the involved level

Patient age for InFUSE (lumbar)Skeletally mature: 18 years or older or radiographic evidence of epiphyseal closure

Patient age for InFUSE/MASTERGRAFT posterolateral revisionSkeletally mature: older than 21 years or radiographic evidence of epiphyseal closure

Proven / medically necessary criteria

Unproven and not medically necessary

Coverage rationale and evidence summary

Autologous iliac crest bone graft (ICBG) is described as the historical gold standard for spinal fusion because it provides osteoconductive, osteoinductive, and osteogenic properties, though it carries donor‑site morbidity. The brief notes that biologic products (BMA, rhBMP‑2, DBM) may improve fusion, but overall the quality of evidence for many alternate products (including many cell‑based, amniotic, ceramic, synthetic, and bioactive glass products) is limited or low and constrained by small trials, single‑center designs, sponsorship bias, and short follow‑up.

Highlighted evidence summaries

rhBMP-2 fusion successMeta-analysis reported ~5.5x higher fusion success versus ICBG

rhBMP-2 reoperation rateReoperation rates ~60% of ICBG (i.e., lower than ICBG) per meta-analysis

MagnetOs Granules trialMulticenter intra-patient RCT showed noninferiority and per-segment superiority vs autograft for PLF (Stempels et al. 2024)

Expandable vs static cages meta-analysisExpandable cages increased anterior disc height and segmental lordosis but no consistent clinical benefit vs static cages (Lee et al. 2023)

Relevant procedure codes and referenced devices

Reference procedure codes (provided for reference only)CPT

0814T	Percutaneous injection of calcium-based biodegradable osteoconductive material, proximal femur, including imaging guidance, unilateral.
20930	Allograft, morselized, or placement of osteopromotive material, for spine surgery only (List separately in addition to code for primary procedure).
20931	Allograft, structural, for spine surgery only (List separately in addition to code for primary procedure).
20939	Bone marrow aspiration for bone grafting, spine surgery only, through separate skin or fascial incision (List separately in addition to code for primary procedure).
22899	Unlisted procedure, spine

FDA-cleared/approved devices referencedmixed

OptiMesh K014200 / De Novo DEN200010	OptiMesh Expandable Interbody Fusion System (510k 2003; De Novo 2020) - informational
InFUSE P000058 / HDE 375525	InFUSE Bone Graft/LT-CAGE (510k 2002; HDE supplement 2008) - informational
i-FACTOR PMA ID 320591	i-FACTOR peptide enhanced bone graft (PMA/510k 2015) - informational
Bicera K172237	Bicera Resorbable Bone Substitute (501k 2018) - informational
Duo K210155	Duo Expandable Interbody Fusion System (510k Feb 2021) - informational

Prior authorization and documentation requirements

Documentation Required

Medical records documentation may be required

Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage; documentation does not guarantee coverage.

Prior Authorization

Coverage limited to FDA-indicated approaches/devices for InFUSE

InFUSE for lumbar spine is covered only when used via an anterior or oblique approach and in conjunction with an FDA‑approved interbody fusion device, and when all other listed clinical criteria are met (skeletally mature individual, L2–S1 fusion, single level, etc.).

Anterior or oblique approach required
Use with an FDA‑approved interbody fusion device required

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 (MedicineNet, 2022).
Autograft
Tissue grafted into a new position in the body of the same individual (Elsevier, 2022).
Bioactive Glass
Silicate glass-based materials with osteoconductive and osteoinductive properties (Gomez, 2021).
Bone Marrow Aspiration
Removal of a small amount of bone marrow tissue in liquid form for examination (A.D.A.M., 2024).
DBM
DBM (Demineralized Bone Matrix): an allograft produced by dissolving the mineralized portion of bone leaving the collagen matrix and growth factors; the collagen matrix provides weak osteoconductive capacity while retained growth factors are osteoinductive; DBM must be combined with a carrier. (Pinter, 2022).
InFUSE
InFUSE Bone Graft: an absorbable collagen sponge coated in rhBMP-2 used for certain spine indications; approved for lumbosacral spine (L2–S1). (Medtronic, 2018).
Osteoconduction
Process where bone grows on a surface (scaffold). (Albrektsson, 2001).
Osteoinduction
Process by which osteogenesis is induced via recruitment and stimulation of immature cells to develop into pre-osteoblasts. (Albrektsson, 2001).
ICBG
Iliac crest bone graft (autograft harvested from the patient's iliac crest).
PLF
Posterolateral fusion.
ALIF/PLIF/TLIF/XLIF
Anterior/Posterior/Transforaminal/Extreme lateral interbody fusion approaches.
rhBMP-2
Recombinant human bone morphogenetic protein-2. (Definition included under BMPs/rhBMPs).
AICB
Autogenous iliac crest bone. (Autograft source from the iliac crest).
BMA
Bone marrow aspirate. (See Bone Marrow Aspiration).

Evidence and key studies

Selected evidence summaries

Systematic review for InFUSE (rhBMP-2)A1 evidence supports use in adults L2-S1 interbody fusion; comparable to ICBG with less operative time/blood loss (Fitzgerald et al., 2025)

ECRI assessmentsMultiple ECRI Clinical Evidence Assessments (2016-2024) conclude evidence for many cell-based/allograft and some synthetics is inconclusive or very low quality

rhBMP-2 meta-analysis outcomesLiu et al. 2020: fusion success ~5.5x ICBG; reoperation rates ~60% of ICBG; adverse events not significantly different but long-term risks uncertain

AttraX Putty trialIntra-patient randomized noninferiority trial (Lehr et al. 2020): AttraX fusion 55% vs autograft 52% at 1 year; noninferiority margin met

MagnetOs Granules trialMulticenter RCT (Stempels et al. 2024): intra-patient PLF trial showed noninferiority and superiority per-segment vs autograft with noted limitations

Expandable cages meta-analyses

Policy revision history

04/01/2026revised

Template update removed content/language pertaining to the state of Louisiana.

12/01/2025added

Added language clarifying Ceramic-Based Products used alone or in combination with other grafts and/or BMA are unproven and not medically necessary.

12/01/2025added

Added medical records documentation language clarifying benefit coverage is determined by federal/state/contractual requirements and that documentation may be required for review.