CurrentUnitedHealthcarePolicy CSOOILAP

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

UnitedHealthcare Community Plan medical policy governing use of bone grafts, bone healing enhancement products, and osteobiologics for spinal fusion for Louisiana members only.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSOOILAP

Change TypeCode updateevidence/reference updatesarchival

Effective DateDec 1, 2024

Next Review Date

Key ActionVerify that product use and documentation meet FDA labeling and policy criteria and follow applicable state or contractual benefit requirements before seeking coverage.

SourceLink

POLICY UPDATE CHANGES

Applicable Codes Added notation to indicate CPT code 0814T is not on the State of Louisiana Medicaid Fee Schedule and therefore are not covered by the State of Louisiana Medicaid Program.

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

Archived previous policy version CSOOILA.0.

Louisianajurisdiction

Multipleosteobiologic categories addressed

Severalexplicitly covered examples

Cell-based/amniotic

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explicitly not medically necessary

93%mean SiCaP fusion rate reported

0814TCPT code noted as not on LA Medicaid fee schedule

Medically Necessary and Not Medically Necessary Criteria

Proven and medically necessary spinal fusion enhancement

Covered when ALL of the following are met:

ALL of the following

Demineralized Bone Matrix (DBM) without added products listed below as unproven and not medically necessary
Autografts (including Bone Marrow Aspirate used for bone grafting)
Allograft-based products not listed below as unproven and not medically necessary
applicability tied to interbody fusion procedures
Approach is anterior or oblique and used in conjunction with an FDA-approved interbody fusion device
Approach requirement: anterior or oblique with FDA-approved interbody device

InFUSE (rhBMP-2) for lumbar spine — covered when ALL criteria met

InFUSE (rhBMP-2) of the lumbar spine is covered when ALL of the following are met:

ALL of the following

Skeletally mature individual (18 years of age or older or radiographic evidence of epiphyseal closure)>= 18 years (or radiographic epiphyseal closure)
Diagnosis of degenerative disc disease (DDD)
Fusion is single levelsingle level
- ONE of

InFUSE + MASTERGRAFT Posterolateral Revision Device System — covered when ALL criteria met

InFUSE/Mastergraft Posterolateral Revision Device System is covered when ALL of the following are met and used per FDA labeling:

ALL of the following

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

Proven and medically necessary additional products/uses (Instructions for Use section)

Other proven and medically necessary items (per Instructions for Use):

ANY of the following

rhBMP-2 (InFUSE) and InFUSE/Mastergraft for indications not separately listed above when used per FDA instructions
Bioactive Glass used alone or in combination with other grafts including Bone Marrow Aspirate
Ceramic-Based Products (beta-TCP, calcium phosphate, calcium sulfate) used alone or in combination with other grafts including Bone Marrow Aspirate
Expandable Interbody Fusion System

Unproven and not medically necessary

The following are considered unproven and not medically necessary:

ANY of the following

Cell-based products (e.g., mesenchymal stem cells, Osteocel, other living cell-containing allografts)
Allograft-based products composed of human amniotic tissue materials, including amniotic fluid stem cell substitutes

General conclusions from evidence summaries

Coverage/clinical-use considerations based on the available evidence summaries:

ALL of the following

Ceramic-based bone graft substitutes: Evidence is mixed — some RCTs and case series support use as a standalone or extender in specific procedures (e.g., XLIF, PLF) but high-quality, large RCTs are lacking to demonstrate superiority to iliac crest bone graft (ICBG).
Bioactive glass: Preliminary studies (retrospective, small prospective) suggest safety and efficacy in some cervical and lumbar fusion contexts, but insufficient high-quality evidence to determine equivalence to ICBG.
rhBMP-2: Produces higher fusion rates in some contexts but associated with unique complications; evidence supports selective use (e.g., high risk for nonunion) and not for routine use in single-level posterior/posterolateral fusions or routine cervical fusions.
Expandable interbody fusion systems: Evidence is limited (mostly retrospective and low-level); radiographic improvements reported but no clear clinical superiority over static cages; unproven without larger RCTs and longer follow-up.

Specific evidence-based position summaries (guideline excerpts)

Guideline-derived indications and cautions (AANS, NASS):

ANY of the following

AANS: DBM may be used as a bone extender for 1- and 2-level instrumented posterolateral fusions.
AANS: b-TCP with local autograft is an option as substitute for ICBG for single-level instrumented posterolateral fusion.
AANS: HA with local autograft/BMA is an option as substitute for ICBG in instrumented posterolateral fusion; HA can be extender when mixed with ICBG.
AANS: Calcium sulfate mixed with local autograft is an option as substitute for ICBG in instrumented posterolateral fusions.
AANS: rhBMP-2 associated with unique complications—surgeons should be aware; insufficient evidence for some standalone uses.

Relevant Procedure and Regulatory Codes

Referenced procedure codesCPT|ICD-10

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

Regulatory / Device approvals mentionedmixed

510(k)	FDA premarket notification pathway referenced for Bicera, InFUSE, i-FACTOR and others
HDE	Humanitarian Device Exemption referenced for InFUSE MASTERGRAFT
De Novo	De novo classification referenced for OptiMesh expanded indications

CPT codes with special LA Medicaid noteCPTNot Covered

0814T

Not on the State of Louisiana Medicaid Fee Schedule and therefore not covered by the State of Louisiana Medicaid Program (per policy history).

Documentation, Prior Authorization, and Billing Guidance

Documentation Required

Adhere to FDA indications and labeling

Products such as InFUSE and InFUSE/Mastergraft must be used according to FDA indications, contraindications, warnings, and precautions; document that the patient meets policy age, diagnosis, level, and approach criteria (e.g., age ≥18 for lumbar InFUSE or >21 for InFUSE/Mastergraft posterolateral revision, diagnosis of degenerative disc disease, single-level L2–S1 with allowed spondylolisthesis ≤ grade 1, and anterior/oblique vs posterolateral approach as applicable).

Document patient age or radiographic evidence of epiphyseal closure.
Document specific diagnosis (e.g., degenerative disc disease) and fusion level(s).
Document surgical approach (anterior/oblique vs posterolateral) and that device use follows FDA labeling.

Documentation Required

Document reason autograft not feasible for posterolateral revision

When seeking coverage for InFUSE/Mastergraft used for posterolateral revision, include clinical documentation that autologous bone and/or bone marrow harvest is not feasible or is not expected to promote fusion, consistent with the policy’s posterolateral revision criteria.

Clinical and Administrative Background

Autologous iliac crest bone graft (ICBG) is described as the historical gold standard for spinal fusion because it provides osteoconductive, osteoinductive, and osteogenic properties, but its use is limited by donor site morbidity associated with harvest (e.g., pain, infection, fracture) and is therefore a frequent reason clinicians and researchers evaluate alternative osteobiologics. (See description of autograft and ICBG and donor site morbidity.)

A broad range of osteobiologic product classes are used or under investigation to improve fusion rates and/or avoid autograft harvest. These include recombinant human bone morphogenetic protein-2 (rhBMP-2, e.g., InFUSE), demineralized bone matrix (DBM), structural and morselized allografts, ceramic-based products (for example beta-tricalcium phosphate, calcium phosphate, calcium sulfate), bioactive glass, and newer cell-based products and human amniotic tissue derivatives. The policy lists additional device classes such as expandable interbody fusion systems used to contain graft material. (Definitions and product lists provided.)

The quality and quantity of clinical evidence vary substantially across these classes. Moderate-quality systematic reviews and randomized trials support selective uses of rhBMP-2 (with known unique complication profiles) and many allograft/DBM and some ceramic and bioactive glass products as extenders or substitutes in specific procedures, but evidence is heterogeneous. By contrast, the literature for cell-based products and human amniotic tissue is limited, biased, and of low quality (small cohorts, short follow-up, manufacturer sponsorship), and the policy identifies these classes as lacking sufficient high-quality evidence to support effectiveness and safety and therefore considers them unproven and not medically necessary. (Evidence summaries and conclusions cited.)

This document is the UnitedHealthcare Community Plan medical policy governing the use of bone grafts, bone healing enhancement products, and osteobiologics for spinal fusion procedures for Louisiana members only. The policy includes coverage criteria, applicable codes (with state-specific fee-schedule notes), definitions, clinical evidence summaries, and instructions for use and is effective 12/01/2024.

Key Terms and Definitions

Definitions

AllograftTransplant of tissue from one individual to another of the same species with a different genotype.

AutograftTissue transplanted from one part of the body to another in the same individual.

Bioactive GlassSilicate glass-based materials with osteoconductive and osteoinductive properties.

Bone Marrow AspirateLiquid bone marrow aspirated through a needle used for grafting.

BMP / rhBMP-2Bone morphogenetic proteins: osteoinductive proteins; recombinant forms (rhBMP) are produced via recombinant DNA technology.

Ceramic-Based ProductsMineral salts (e.g., hydroxyapatite, calcium phosphate, tricalcium phosphate, calcium sulfate, bioactive glass) produced to provide osteoconductive scaffolds.

Age, Level, and Spondylolisthesis Thresholds

Policy Thresholds

Age for InFUSE lumbar indication>= 18 years (or radiographic epiphyseal closure)

Age for InFUSE/Mastergraft posterolateral revision> 21 years (or radiographic epiphyseal closure)

Spondylolisthesis allowance<= grade 1 (<= 25% displacement)

Fusion level limitationSingle level, between L2 and S1

93%Mean fusion rate reported for SiCaP across studies

86.4%Overall fusion rate for ceramic products as bone extender in lumbar spine (systematic review)

Policy Changes and Version Notes

2024-12-01code update (Louisiana Medicaid)Latest

Added notation that CPT code 0814T is not on the State of Louisiana Medicaid Fee Schedule and therefore is not covered by the State of Louisiana Medicaid Program.

2024-12-01bibliography/evidence update

Updated Clinical Evidence and References sections to reflect the most current information; this change did not by itself alter coverage criteria.

2024-12-01archival

Archived previous Louisiana-specific policy version CSOOILA.0.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSOOILAP

Change TypeCode updateevidence/reference updatesarchival

Effective DateDec 1, 2024

Next Review Date

Key ActionVerify that product use and documentation meet FDA labeling and policy criteria and follow applicable state or contractual benefit requirements before seeking coverage.

SourceLink

On This Page

Without spondylolisthesis at the involved level

With spondylolisthesis of no more than grade 1 (<= 25% displacement) at the involved level<= grade 1 (<= 25% displacement)

NASS: Structural allograft indicated for a range of anterior cervical reconstruction scenarios and posterior cervical fusion in specified situations.

NASS: DBM may be indicated in anterior cervical reconstruction/fusion and in thoracolumbar and interbody fusions (often with autograft); limited evidence for DBM as standalone in non-instrumented anterior fusions.

NASS: ICBG remains the gold standard; allograft used frequently due to morbidity of ICBG harvest.

NASS on rhBMP-2: May be considered adjunct in selected diagnoses (high risk for nonunion, stand-alone ALIF except certain male patients, pediatric very high risk, posterior cervical/thoracic fusions), and should not be used routinely for single-level posterolateral fusions in healthy adults or routine cervical/pediatric fusions.

State why autologous bone or bone marrow harvest is infeasible or unlikely to promote fusion in the specific patient chart note.
Include that the indication is symptomatic posterolateral lumbar pseudoarthrosis and that implantation is via a posterolateral approach.

Documentation Required

Be aware of unique complications and document indications

When using rhBMP-2 or novel bone substitutes, document the specific clinical indication (for example, high risk for nonunion or inadequate/poor-quality autograft), the procedure type, and that the patient was counseled about unique complication risks associated with rhBMP-2.

Record rationale for use (e.g., high risk for nonunion, revision surgery, inadequate autograft).
Document counseling about rhBMP-2–specific complications (e.g., inflammation, ectopic bone, osteolysis) and informed consent discussion.
Include procedure type (e.g., ALIF, PLIF, TLIF, posterolateral fusion) and level(s) in the operative note.

Prior Authorization

Prior authorization / utilization review may be required for novel grafts/devices

Expect that utilization management or prior authorization may be required for many ceramic, bioactive glass, expandable interbody systems, and other novel grafts/devices; be prepared to justify medical necessity with clinical risk factors, procedure type, and supporting evidence.

Provide documentation of patient-specific risk factors for nonunion or rationale for using the novel product instead of standard options.
Specify the planned procedure type and level(s) and reference relevant evidence or FDA indications in the authorization request.
Follow any plan-specific prior authorization process and supply requested clinical records.

Denial Risk

Risk of non-coverage for routine use

Guidelines identify rhBMP-2 as inappropriate for routine use in certain settings; routine use for single‑level posterolateral fusions in healthy adults and routine cervical fusion uses are considered inappropriate and may be denied.

Do not expect coverage for routine single‑level posterolateral fusions in healthy adults using rhBMP-2.
Do not expect routine coverage for cervical fusion uses of rhBMP-2 unless guideline‑supported indications are met (e.g., high risk for nonunion).

Documentation Required

Check state/contractual requirements

Verify federal, state, or contractual plan requirements prior to using products covered by this policy because those requirements govern in the event of a conflict with the policy.

Check the member’s plan and applicable state (Louisiana) fee schedule and coverage rules before scheduling the procedure.
Note that CPT code 0814T is not on the State of Louisiana Medicaid Fee Schedule and therefore is not covered for Louisiana Medicaid members.

Prior Authorization

Adhere to plan utilization tools

Follow UnitedHealthcare’s utilization management and prior authorization processes; the plan may use third‑party tools (such as InterQual) to assist in administering benefits, so comply with applicable tool criteria and submission requirements.

Submit required prior authorization forms and clinical documentation per plan instructions.
If InterQual or other criteria are referenced, ensure the request aligns with those tool criteria where applicable.

Providers should note the state-specific operational coding clarification: CPT code 0814T is explicitly called out in the policy history as not on the State of Louisiana Medicaid Fee Schedule and therefore not covered by the Louisiana Medicaid Program; verify plan and state/contractual requirements prior to submitting claims.

Expandable Interbody Fusion SystemInterbody implant designed to expand in situ to provide mechanical support and contain graft material (examples: Duo Ti, OptiMesh).

Human Amniotic Tissue MembraneMultilayer tissue from the innermost amniotic sac layer; composed of epithelial, basement membrane, compact, fibroblast, and spongy layers.

ICBGIliac crest bone graft — autologous bone graft harvested from the patient's iliac crest (considered gold standard).

rhBMP-2 (recombinant human BMP-2)Recombinant human bone morphogenetic protein-2 — an osteoinductive protein used to promote spinal fusion; associated with specific complication profile.

DBM (repeat)Demineralized bone matrix — processed allograft bone used as bone graft extender or adjunct.

SiCaPSilicate-substituted calcium phosphate — a ceramic bone graft substitute reported to have high fusion rates in pooled studies.

Medical PolicyDocument to assist in interpreting UnitedHealthcare standard benefit plans; federal, state, or contractual requirements govern if they differ from the policy.

Two-year fusion rate reported for Luna 3D expandable device

55%1-year fusion rate for AttraX Putty (intra-patient RCT) vs autograft 52%