ModifiedUnitedHealthcarePolicy CS009KS.02

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

Medical policy governing coverage and medical necessity of autografts, allografts, bone graft substitutes, and specific bone healing enhancement products for spinal fusion in Kansas members and providers.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS009KS.02

Change TypeMaterial clinical coverage updates

Effective DateDec 1, 2025

Next Review Date

Key ActionRequire documentation of medical history, physical exam and relevant diagnostic tests to support medical necessity; maintain legible records and make available upon request.

SourceLink

POLICY UPDATE CHANGES

Added language to clarify Ceramic-Based Products 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 medical records documentation may be required to assess whether the member meets clinical criteria and listing examples of required documentation.

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 most current information.

Kansas-onlyjurisdiction

A1 evidenceInfuse (rhBMP-2)

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Coverage Criteria and Policy Positions

Covered products and specific covered indications

Covered when ALL of the following are met for the listed products or indications:

General covered products: Autografts (including Bone Marrow Aspirate [BMA] used for bone grafting); Demineralized Bone Matrix (DBM) without added products listed as unproven; Allograft-based products not listed as unproven are considered proven and medically necessary.

InFUSE (rhBMP-2) — lumbar interbody fusion (L2–S1): InFUSE (rhBMP-2) is covered for lumbar spine when all of the following are met: approach is anterior or oblique and used with an FDA-approved interbody fusion device; patient is skeletally mature (≥18 years or radiographic epiphyseal closure) with degenerative disc disease (DDD); fusion involves vertebral bodies L2–S1 with spondylolisthesis ≤ grade 1; and fusion is single-level.on-label use L2–S1

InFUSE/MASTERGRAFT Posterolateral Revision Device System (or InFUSE BMP used with MASTERGRAFT) is covered when used per FDA labeling and all of the following are met: implanted via posterolateral approach; presence of symptomatic posterolateral lumbar spine 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 not expected to promote fusion.

Use limited to FDA-indicated posterolateral pseudoarthrosis population.

Not medically necessary / unproven products

Not covered (unproven and not medically necessary) due to insufficient evidence of efficacy and/or safety:

Unproven allograft-based products: Allograft-based cell-based products (e.g., mesenchymal stem cells [MSC]); human amniotic tissue materials including amniotic fluid stem cell substitutes.

Recombinant BMP and related devices — off-label uses: 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 indications not included in the covered criteria are considered unproven and not medically necessary.

Ceramic-based products and combinations: 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.

Bioactive glass used alone or in combination with other grafts including Bone Marrow Aspirate (BMA) is unproven and not medically necessary.

Evidence-based coverage considerations

Summary of coverage-relevant evidence and clinical guidance derived from cited studies

rhBMP-2 (Infuse) — lumbar interbody fusion evidence: Systematic reviews and RCTs provide A1-level evidence supporting Infuse (rhBMP-2) for lumbar interbody fusion in L2–S1, showing comparable or improved fusion rates versus iliac crest autograft and benefits such as reduced operative time and blood loss; however heterogeneity of studies and limited long-term data temper conclusions.on-label use L2–S1

Evidence base includes Fitzgerald et al. (2025) systematic review and others; strength limited by variability in study design and follow-up.

rhBMP-2 (Infuse) — cervical fusion safety concerns: Available evidence demonstrates higher fusion rates but a higher rate of adverse events with rhBMP-2 used in cervical fusion; systematic reviews and FDA warnings note life‑threatening complications with off-label cervical use and risks may outweigh benefits.off-label cervical use requires strong justification

Authorization should require documentation of contraindications to alternatives and informed consent about risks.

Overall evidence summary

Evidence-based stance and summarized findings

Ceramic-based products — trial results and limitations: Randomized intra-patient noninferiority trials and systematic reviews report similar or noninferior fusion rates for some ceramic products (e.g., MagnetOs Granules, AttraX Putty, SiCaP) versus autograft in instrumented posterolateral fusion and some interbody procedures, but these studies have limitations including intra-patient design, small sample sizes, heterogeneous methodologies, limited patient‑reported outcome attribution, and short-term follow-up.

Bioactive glass — limited evidence: Evidence for bioactive glass is limited and generally low quality; case series and small prospective studies report radiographic fusion and clinical improvements, but randomized trials comparing bioactive glass to ICBG/autograft are lacking.

Expandable interbody fusion systems — insufficient data: Expandable interbody fusion systems lack prospective randomized controlled trials with adequate sample size and long-term follow-up; existing data are very low quality and often do not report patient‑oriented outcomes, leaving clinical efficacy unproven.

Ceramic-Based Products (and BMA) — Not Medically Necessary

Policy position added in revision

Ceramic-Based Products Not Medically Necessary: 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 12/01/2025

Use of the InFUSE/MASTERGRAFT Posterolateral Revision Device (including InFUSE BMP used with MASTERGRAFT or MASTERGRAFT alone) is limited to the FDA-labeled posterolateral pseudoarthrosis indication. Use of these products for posterolateral indications not included in the covered criteria is considered unproven and not medically necessary due to insufficient evidence of efficacy and safety.

Human amniotic tissue products and related cell-based allografts lack sufficient high-quality human data to establish safety and effectiveness for lumbar spinal fusion. The literature search shows only limited evidence in human models, and long-term safety and efficacy have not been established; therefore these products are considered unproven and not medically necessary for spinal fusion.

Published clinical evidence does not demonstrate that ceramic bone graft substitutes are superior to iliac crest bone graft (ICBG) or autograft. Existing trials are heterogeneous, frequently small or intra‑patient in design, and limited by short follow-up and assessment challenges (for example, CT reliability and radiologic similarity between ceramics and bone). Large, well‑designed randomized controlled trials comparing specific ceramic or ceramic+bony graft combinations to ICBG/autograft are needed before superiority can be concluded.

Recombinant human BMP‑2 (rhBMP‑2, InFUSE) has specific use limitations. Evidence supports its use for lumbar interbody fusion in L2–S1 on‑label, but routine use in cervical fusion is not recommended because of higher rates of adverse events and society guidance advising against routine anterior/posterior cervical use and routine single‑level posterior/posterolateral fusions in healthy adults. Off‑label cervical use has documented life‑threatening complications and requires strong justification and careful authorization review.

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. This policy revision explicitly operationalizes that stance based on insufficient evidence of clinical benefit when used alone or combined.

Human amniotic tissue materials and cell‑based allograft products (e.g., MSC‑based preparations) are considered unproven and not medically necessary for spinal fusion due to lack of robust evidence demonstrating safety and efficacy.

Use of human amniotic tissue membrane specifically for lumbar spine fusion is unsupported by sufficient human evidence; long‑term safety and efficacy have not been established, and therefore this application is considered unproven and not medically necessary.

Expandable interbody fusion systems are considered unproven. The evidence base lacks prospective randomized controlled trials with adequate sample size and long‑term follow‑up to determine clinical efficacy, and available studies often do not report patient‑oriented outcomes; use may therefore be considered not medically necessary pending stronger evidence.

Ceramic‑based products used alone or in combination with other grafts and/or graft components, including BMA, remain classified as unproven and not medically necessary. This position is reflected in the policy revision effective 12/01/2025 and reiterates that such combinations do not currently meet the evidence threshold for coverage.

Procedure and Billing Codes

Applicable procedure codes (reference)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

Prior Authorization, Documentation, and Provider Guidance

Prior Authorization

Prior Authorization Required for rhBMP-2

Prior authorization is required for use of recombinant human BMP-2 (rhBMP-2; InFUSE ™) — verify that the requested use matches a covered indication and spinal level. Covered lumbar indications are limited to skeletally mature individuals (≥18 years or radiographic epiphyseal closure) with degenerative disc disease (DDD) undergoing a single-level anterior or oblique interbody fusion (ALIF/OLIF) at L2–S1 (with ≤ Grade 1 spondylolisthesis) using an FDA‑approved interbody fusion device. For posterolateral revision use, confirm adherence to the MASTERGRAFT/InFUSE labeling and FDA indications (posterolateral approach, symptomatic pseudoarthrosis, skeletally mature >21 years, and autologous bone/marrow harvest not feasible or unlikely to promote fusion).

Confirm surgical approach, level(s), and single‑level status
Document age/epiphyseal closure and diagnosis of DDD
Confirm use with an FDA‑approved interbody device for ALIF/OLIF
For posterolateral revision, document pseudoarthrosis and rationale why autograft/BMA is not feasible

Note

Coverage Decision References and Criteria Sources

Clinical Background and Evidence Context

Autologous iliac crest bone graft (ICBG) has historically been the reference standard for spinal fusion because it provides osteoconductive, osteoinductive, and osteogenic properties. While ICBG is associated with donor‑site morbidity, comparative evidence for many biologic and synthetic substitutes remains limited; clinical trials frequently use ICBG or autograft as the comparator, underscoring its role as the established standard in fusion studies.

Definitions and Key Terms

Autograft — definition and notes

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

Common sourceIliac crest bone graft (autologous iliac crest bone) is the historical gold standard for spinal fusion (provides osteoconductive, osteoinductive, and osteogenic properties).

Clinical noteAvoids immunologic rejection because donor and recipient are the same person; associated with donor-site morbidity.

Allograft — definition and regulatory note

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

Regulatory note

Policy Revision History

2025-12-01policy_revisionLatest

Added coverage rationale clarifying that ceramic-based products (e.g., b-TCP, calcium phosphate, calcium sulfate) used alone or in combination with other grafts or graft components, including bone marrow aspirate (BMA), are unproven and not medically necessary; added detailed medical records documentation requirements and new/updated definitions; updated clinical evidence, FDA, and references sections.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS009KS.02

Change TypeMaterial clinical coverage updates

Effective DateDec 1, 2025

Next Review Date

Key ActionRequire documentation of medical history, physical exam and relevant diagnostic tests to support medical necessity; maintain legible records and make available upon request.

SourceLink

On This Page

Expandable interbody fusion systems are considered unproven and not medically necessary due to insufficient high-quality evidence.

Alternative osteobiologics and synthetics: The literature for other osteobiologics (allograft variants, DBM, ceramic substitutes, bioactive glass, cell-based matrices) is heterogeneous; some single studies or small trials report promising fusion rates (e.g., MagnetOs, SiCaP, AttraX Putty), but overall high-quality comparative evidence demonstrating superiority to autograft/ICBG is lacking.insufficient high-quality comparative evidence to declare superiority

Consider product-specific evidence strength and study limitations when assessing coverage.

The coverage determination for bone graft materials and implants is governed by federal, state, or contractual benefit terms and applicable laws. UnitedHealthcare uses InterQual® as the primary medical/surgical criteria; when InterQual® is not applicable, UnitedHealthcare Medical Policies approved by the Kansas Department of Health and Environment may be used. FDA clearance/510(k) or PMA status is informational only and does not by itself establish coverage.

Verify plan/federal/state/contractual coverage requirements prior to authorization
InterQual® may be applied for medical necessity review
FDA clearance is not equivalent to coverage

Denial Risk

rhBMP-2 Cervical Use — Safety Risk

Documented safety concerns exist for rhBMP-2 when used in the cervical spine. The FDA has warned that off‑label cervical use can cause life‑threatening adverse events (e.g., airway compression, neurologic compromise). Systematic reviews report higher adverse event rates for cervical fusion with rhBMP-2; weigh risks versus benefits and document alternative options considered.

Do not request cervical rhBMP-2 without explicit justification and documentation of anticipated benefit over risk
Document discussion of FDA warnings and informed consent addressing potential airway/neurologic risks

Documentation Required

Medical Records Requirements and Denial Triggers

Medical records must fully support the medical necessity for the requested service. Benefit coverage is determined by federal, state, or contractual requirements and applicable law; documentation may be requested to assess whether clinical criteria are met but does not guarantee coverage. Missing, illegible, or incomplete documentation may result in denial or delayed authorization.

Include relevant medical history, focused physical exam, and results of diagnostic tests
Ensure records are legible, retained in the patient chart, and available upon request
Note that documentation insufficiency is a frequent cause for denial

Documentation Required

Imaging and PROM Documentation

Provide preoperative imaging and patient‑reported outcome measures (PROMs) to support the request. Imaging such as CT (for fusion assessment) and relevant radiographs should document the pathology and planned level(s). Include baseline PROMs (e.g., Oswestry Disability Index [ODI], Visual Analog Scale [VAS]) and other objective measures when available.

Attach preoperative CT or high‑quality radiographs showing level(s) and pathology
Include baseline ODI and VAS scores and indicate expected follow‑up PROM schedule
If prior conservative management applied, include documentation of nonoperative treatments and response

Documentation Required

Imaging and PRO Reporting Expectations

When imaging or outcomes are referenced from studies or device reports, provide study‑relevant details (modality, timing, score changes) and how these relate to the member’s anticipated benefit. For authorization of fusion‑enhancing implants, document radiographic fusion intent and planned follow‑up imaging schedule.

State planned postoperative imaging timeline (e.g., CT at 12 months when indicated)
Relate expected fusion endpoints to published PROM and radiographic outcomes

Note

Device Clearance and Product Documentation

For devices and implants, include device identifiers and clearance information. Specify the device name, model, and whether the device has FDA 510(k) clearance or PMA for the proposed indication. Note: FDA clearance is informational and does not assure coverage; HCT/P classification for allografts is regulated separately.

Provide device name/model and 510(k)/PMA reference if available
If using an HCT/P product or allograft, indicate minimally manipulated status and any combinations that change regulatory classification

Prior Authorization

Graft and Device Selection — Consider Established Options First

Clinical sequencing expectations: consider autograft (iliac crest bone graft or local autograft/BMA) before rhBMP-2 where feasible, and prefer established graft materials (autograft, allograft, DBM) over novel or unproven substitutes or expandable/novel interbody systems unless compelling, documented rationale exists.

Document why autograft is not feasible or appropriate if bypassing autograft
Provide literature or device‑specific rationale when requesting novel implants or substitutes
Requests for expandable interbody systems or other unproven devices require robust justification and supporting evidence

Note

Additional Provider Actions / Unspecified Guidance

Not all provider actions are specified in this segment of the policy. For questions about authorization requirements, coding, or documentation expectations not detailed here, contact UnitedHealthcare provider services or reference the applicable InterQual® criteria and the member’s plan documents.

Use payer/provider helpdesk for case‑specific inquiries
Attach InterQual® documentation when used to support medical necessity

Allografts are considered tissues for transplantation and regulated as HCT/P; if combined with other materials the resulting product may be regulated as a device.

Clinical noteMay be used as structural or morselized graft material; immunologic and processing considerations differ from autograft.

Demineralized Bone Matrix (DBM)

DefinitionDemineralized Bone Matrix (DBM): an allograft produced by dissolving the mineralized portion of bone and leaving the collagen matrix and retained growth factors.

PropertiesCollagen matrix provides weak osteoconductive capacity; retained growth factors are osteoinductive.

Clinical useDBM requires combination with a carrier or scaffold to serve as a more potent osteoconductive scaffold for grafting.

InFUSE (rhBMP-2) — key definition

Product classInFUSE (rhBMP-2): a bone graft product that contains recombinant human bone morphogenetic protein-2 (rhBMP-2) applied on an absorbable collagen sponge to stimulate bone formation.

MechanismRhBMP-2 is an osteoinductive growth factor that promotes differentiation of local mesenchymal stem cells into osteoblasts to achieve vertebral fusion.

Intended effectUsed to promote fusion and obviate the need for autologous bone harvest by stimulating natural bone growth when used with an interbody device.

Infuse (rhBMP-2) — product brief and regulatory status

FDA-approved productInFUSE Bone Graft: the only FDA‑approved spinal fusion product containing rhBMP-2; an absorbable collagen sponge coated in rhBMP-2 used with an interbody fusion device for lumbosacral fusion (L2 to S1).

Regulatory historyFDA granted 510(k) premarket approval and supplements for the InFUSE Bone Graft/LT‑CAGE; Infuse is approved in the U.S. only for lumbosacral spine fusion L2–S1.

Clinical considerationInfuse is intended to achieve vertebral fusion by promoting natural bone growth and eliminate the need for iliac crest autograft in approved indications.

Bioactive glass — definition and evidence note

DefinitionBioactive glass: a class of synthetic silica‑based materials typically composed of SiO2, CaO, Na2O, and P2O5 with claimed rapid hydroxyl carbonated apatite formation and osteoconductivity.

PropertiesClaimed to promote faster HCA and bone bonding formation and higher osteoconductivity than some other synthetic ceramics.

Evidence noteThere is insufficient high-quality evidence to draw definitive conclusions on efficacy and safety compared with established grafts.

Biphasic calcium phosphate (BCP)

DefinitionBiphasic calcium phosphate (BCP): a ceramic bone substitute combining phases of calcium phosphate designed to be resorbable and osteoconductive.

ExamplesExamples include products such as MagnetOs Granules and AttraX Putty evaluated in instrumented posterolateral fusion trials.

Clinical evidenceRandomized intra‑patient trials report noninferior or variable fusion rates versus autograft, but studies have design limitations and limited long‑term outcome data.

Allograft — HCT/P regulatory note

Regulatory classificationAllografts are regulated as human cells, tissues, and cellular and tissue‑based products (HCT/P) when minimally manipulated for transplantation.

Combined productsIf an allograft is combined with other materials, the resulting product is considered a device and regulated by the FDA as a medical device.

ReferenceSee FDA tissue/HCT/P guidance and device databases for product‑specific regulatory status.

Device regulatory status — 510(k), De Novo, PMA (definitions/examples)

510(k) clearance510(k): FDA premarket notification demonstrating substantial equivalence to a legally marketed device (examples: i‑FACTOR peptide enhanced bone graft 510(k in 2015; Duo™ Expandable Interbody Fusion System 510(k in 2021 for L2–L5).).

De Novo classificationDe Novo: a pathway for novel low‑to‑moderate risk devices without a predicate (example: OptiMesh® received De Novo for expanded indications in 2020).

PMA/HDE/otherPMA (premarket approval) is required for high‑risk devices; the InFUSE/MASTERGRAFT Humanitarian Device Exemption and PMA/510(k) actions are listed in FDA device records.

Osseointegration, Osteoconduction, Osteoinduction — definitions

OsseointegrationOsseointegration: the stable anchorage of an implant achieved by direct bone‑to‑implant contact.

OsteoconductionOsteoconduction: process in which new bone grows on a surface or scaffold (bone grows on the surface).

OsteoinductionOsteoinduction: the recruitment and stimulation of immature cells to develop into preosteoblasts, inducing osteogenesis.

Updated definitions: Allograft; Autograft; Bone Marrow Aspiration

Allograft (updated)Updated definition: Allograft—transplant of tissue from one individual to another of the same species with a different genotype; regulatory note that minimally manipulated bone is an HCT/P and combinations may be devices.

Autograft (updated)Updated definition: Autograft—tissue grafted into a new position in the body of the same individual; remains the historical standard for spinal fusion due to combined osteoconductive, osteoinductive, and osteogenic properties.

Bone Marrow Aspiration (updated)Updated definition: Bone Marrow Aspiration—removal of a small amount of bone marrow (liquid form) from the hollow part of bones for use in grafting or examination.