ModifiedCignaPolicy 0118

Bone Graft Substitutes

This policy governs coverage and coding for bone graft substitutes used to enhance bone healing for Cigna-administered health plans, describing which materials are considered medically necessary versus experimental/investigational and specifying coding guidance. It applies to providers submitting claims for bone graft materials and related procedures.

Policy Summary

PayerCigna

PolicyBone Graft Substitutes

Policy CodePolicy 0118

Change TypeAnnual revisionspine delegation

Effective DateFeb 15, 2026

Next Review DateFeb 15, 2027

Key ActionObtain prior authorization confirming product-specific FDA indication (e.g., rhBMP-2 for open tibial shaft fractures with IM nail) and document compliance with coding guidance.

SourceLink

POLICY UPDATE CHANGES

Revised policy statement for the medically necessary statement bone graft materials and/or substitutes, used alone or in combination.

Removed policy statements for spine-related content, which is delegated to EviCore as of 11/01/2024.

Revised policy statement for bone graft materials and/or substitutes.

rhBMP-2 limitedrhBMP-2 indication

rhBMP-7 not coveredrhBMP-7 status

not coveredAmniotic & cell-based

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Policy review cadence

EviCoreSpine delegation

Refs 25-29FDA references

Coverage Criteria for Bone Graft Materials

Medically necessary bone graft materials

Considered medically necessary for enhancement of bone healing when used alone or in combination:

Medically necessary materials: allograft-based, including demineralized bone matrix (DBM); ceramic or polymer-based synthetic bone graft substitutes; bone graft substitutes containing inorganic bone material (e.g., bovine, coral) when used alone or combined with another covered bone graft substitute.

From policy list of covered materials

rhBMP-2 (INFUSE) specific criteria

rhBMP-2 (INFUSE) is considered medically necessary only when BOTH criteria are met:

rhBMP-2 (INFUSE) acute open tibial shaft fracture: Fracture is stabilized with intramedullary (IM) nail fixation; rhBMP-2 is applied within 14 days of the fracture.application within 14 days

Per FDA-approved labeling and policy statement

Device/product-specific covered indications

Covered when ALL of the following are met for product-specific FDA approvals

rhBMP-2 (INFUSE) for open tibial fractures: The fracture is stabilized with intramedullary (IM) nail fixation; rhBMP-2 is applied within 14 days after initial fracture; patient is skeletally mature.

Per FDA-approved labeling

rhBMP-2 for sinus augmentation/alveolar ridge augmentation: Use limited to FDA-approved indications for sinus augmentations and localized alveolar ridge augmentations associated with extraction sockets.

Per FDA-approved labeling

rhBMP-7 (OP-1) HDE for long bone nonunion: Autograft is not feasible AND alternative treatments have failed.

HDE approval; product withdrawn from market per Gillman et al.

Use of rhBMP-2 (INFUSE) for indications other than the limited FDA‑approved uses described in this policy is not covered. Specifically, rhBMP-2 is not medically necessary for sinus augmentation or localized alveolar ridge augmentation when billed as an alternative or adjunct treatment for those indications. Documentation and coding for these dental/oral procedures (for example, codes such as 21208, 21210, 21499, 31299, L8699) should reflect that these uses are excluded from medical coverage in many benefit plans.

Human amniotic membrane products, amniotic fluid‑derived stem cell substitutes, and cell‑based bone graft substitutes (including mesenchymal stem/stromal cell [MSC] therapies and concentrated bone marrow aspirate used alone) are considered experimental, investigational, or unproven for enhancement of bone healing. The clinical evidence is limited, consisting largely of preclinical studies, small or heterogeneous human cohorts, and early‑phase clinical trials, and therefore does not establish sufficient safety and efficacy to support routine coverage.

Recombinant human bone morphogenetic protein‑7 (rhBMP‑7, OP‑1) is considered experimental, investigational, or unproven for all indications. When billed, rhBMP‑7 use is not supported for routine coverage and is included in the policy’s list of non‑covered or investigational interventions.

Ceramic‑based bone graft substitutes are indicated to fill non‑load‑bearing bone voids or gaps and are generally not intended for load‑bearing applications unless used with internal fixation. These materials are typically regulated through the FDA 510(k) pathway (Class II) though some products may require PMA (Class III). For oral, craniofacial, and orthopedic uses, contraindications for adjunctive biologic products (e.g., rhBMPs) include pregnancy, active infection at the operative site, hypersensitivity to product components, and prior or current tumor at the site of use; these clinical limitations should be considered when selecting ceramic substitutes.

Spine‑related coverage statements have been removed from this policy and spine indications are delegated to EviCore effective 11/01/2024. Providers seeking prior authorization or coverage determinations for bone graft substitutes used in spine surgery must follow EviCore Spine Surgery Guidelines and route requests through EviCore as required.

Consistent with FDA‑labeled indications and this policy, rhBMP‑2 is not medically necessary for sinus augmentation or localized alveolar ridge augmentation as an alternative or adjunct except where explicitly covered by the FDA labeling and local plan terms. When these oral/dental procedures are excluded under a member’s benefits, associated bone grafting in support of dental implants (including sinus or alveolar ridge augmentation) is similarly not covered.

Human amniotic membrane and amniotic fluid‑derived products, as well as many mesenchymal stem cell‑based therapies for bone healing, remain experimental or investigational because available human clinical trials are limited in size, heterogeneous in design, and do not provide sufficient high‑quality evidence of safety and efficacy. Until more robust, controlled clinical data are available, these products are not considered standard, medically necessary treatment for bone healing.

Coding and Regulatory Identifiers

Mixed referenced procedure/HCPCS codesmixed

20999	Unlisted procedure, musculoskeletal system, general
27899	Unlisted procedure, leg or ankle
C1734	Orthopedic/device/drug matrix for opposing bone-to-bone or soft tissue-to bone (implantable)
C9359	Porous purified collagen matrix bone void filler (Integra Mozaik Osteoconductive Scaffold Putty), per 0.5 cc
C9362	Porous purified collagen matrix bone void filler (Integra Mozaik Osteoconductive Scaffold Strip), per 0.5 cc
L8699	Prosthetic implant, not otherwise specified
27299	Unlisted procedure, pelvis or hip joint
27599	Unlisted procedure, femur or knee
29999	Unlisted procedure, arthroscopy
38232	Bone marrow harvesting for transplantation; autologous

1–10 of 20

1/2

Regulatory/classification notesmixed

No codes listed

Referenced FDA submissions and device identifiersmixed

P000054	INFUSE BONE GRAFT PMA identifier (Premarket Approval for acute, open tibial shaft fractures)
H010002	OP-1 IMPLANT HDE identifier (rhBMP-7)
K043420	Osteofil Allograft Paste 510(k) Summary
K231716	OsteoFlo HydroPutty 510(k) Summary
K231556	SPECTRUM GV Bone Cement 510(k) Summary
DEN210044	CERAMENT G de novo decision (gentamicin-eluting ceramic bone void filler)
K234008	Associated FDA documentation referenced for DEN210044 (2024)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Coding

Prior authorization is required when the requested bone graft material or substitute is subject to a coverage determination under this policy. Follow the policy clinical criteria and coding guidance when submitting requests. Use the most appropriate CPT/HCPCS/ICD-10 codes as of the date of service; many bone graft materials are reported with unlisted procedure codes (e.g., 20999, 27899, 27299, 27599, 29999) or miscellaneous HCPCS (e.g., L8699, C1734, C9359, C9362, C9359). Claims submitted without covered codes referenced in the applicable Coverage Policy will be denied as not covered.

Prior authorization required when policy criteria apply and for materials billed with unlisted codes
Use most-appropriate codes as of date of service; unlisted CPT/HCPCS codes may be necessary
Claims lacking covered codes under this policy will be denied as not covered

Prior Authorization

Prior Authorization Routing for Spine

Spine-related bone graft and substitute requests are no longer handled under this policy. As of 11/01/2024, authorization and medical necessity determinations for spine procedures and related bone graft materials have been delegated to EviCore. Providers should route all spine-related prior authorization requests to EviCore per the delegated guideline.

Background on Bone Graft Substitutes

Bone graft substitutes include multiple material classes — allograft, synthetic (ceramic/polymer), inorganic, factor‑based, and cell‑based products — that are used to enhance bone healing for fractures, bone defects, and reconstructive procedures. Autograft remains the reference standard but substitutes provide osteoconductive scaffolding and, for some products, osteoinductive or osteogenic properties. Clinical evidence and regulatory pathways vary by product class; selection should align with FDA‑approved indications and the clinical situation.

Definitions and Regulatory Notes

Implant vs surgical supply

Policy distinctionMaterials that are resorbed into the body (e.g., many allograft materials, bone void fillers, synthetic materials, recombinant BMPs) are considered surgical supplies rather than implants.

Implant definitionImplants are devices or materials placed into a surgically or naturally formed cavity to continuously assist, restore, or replace function throughout their useful life (examples: stents, artificial joints, plates, screws).

Resorbable materials noteFDA-defined resorbable materials (e.g., resorbable calcium salt bone void filler) are not considered implants because they dissolve and are replaced by bone tissue over time.

Reimbursement implicationBecause resorbed bone graft substitutes are classified as surgical supplies, they are treated differently than implants for coverage and reporting purposes.

FDA classification notes

Policy Revision History

2026-02-15Annual review - revised policy statementLatest

Annual review revised the medically necessary policy statement for bone graft materials and/or substitutes used alone or in combination.

2025-02-15Annual review - no clinical policy statement changes

Annual review noted no clinical policy statement changes.

2024-11-01Focused review - delegation of spine content

Policy Summary

PayerCigna

PolicyBone Graft Substitutes

Policy CodePolicy 0118

Change TypeAnnual revisionspine delegation

Effective DateFeb 15, 2026

Next Review DateFeb 15, 2027

Key ActionObtain prior authorization confirming product-specific FDA indication (e.g., rhBMP-2 for open tibial shaft fractures with IM nail) and document compliance with coding guidance.

SourceLink

On This Page

Delegation to EviCore effective 11/01/2024 — do not submit spine-related graft requests via this policy routing
See EviCore Spine Surgery Guidelines for spine-related bone graft use

Denial Risk

Claims and Coding Compliance

Services billed without codes covered by this policy or billed with codes that do not align with the clinical indication in the documentation may be denied. Ensure billing and claim submissions follow coding guidance in this policy and reflect the clinical scenario (e.g., open tibial fracture with IM nail when billing for rhBMP-2 under its FDA indication).

Services without covered codes under this policy will be denied as not covered
Ensure documentation supports the diagnosis and procedure codes billed
Unlisted procedure codes should be accompanied by clinical documentation that justifies use and describes the material

Denial Risk

Use of rhBMP-2 Outside FDA-Approved Labeling

Use of rhBMP-2 (INFUSE®) outside of the FDA-approved labeling may result in denial. The policy limits use of rhBMP-2 to FDA-labeled indications; off‑label applications (including many spine uses not covered by the labeled indications) are subject to noncoverage unless otherwise supported by an applicable benefit plan or delegated guideline.

rhBMP-2 use should be limited to FDA-approved labeling (e.g., acute open tibial shaft fractures with IM nail fixation; specific dental indications)
Off-label use may be denied unless plan language or delegated vendor guidelines authorize coverage

Note

Delegation May Affect Authorization Routing

Delegation of spine content to EviCore may change authorization routing and decision authority. Requests for spine procedures or devices that previously might have been reviewed under this policy should be submitted to the delegated vendor per their submission requirements; failure to do so may delay or result in denial of authorization.

Removal of spine content from this policy redirects spine-related authorization requests to EviCore
Confirm delegated vendor requirements and submission process to avoid delays or denials

Billing Rule

Coding Guidance and Documentation

Coding guidance: when specific CPT/HCPCS codes exist, use them. For many bone graft substitutes there is no specific CPT; unlisted musculoskeletal procedure codes (e.g., 20999, 27899, 27299, 27599, 29999) or miscellaneous HCPCS (e.g., L8699, C1734, C9359, C9362, C9362) may be appropriate. Include product identifiers, quantity/volume, and manufacturer/device name on the claim and in the prior authorization request to facilitate adjudication.

Use specific CPT/HCPCS when available; otherwise report the most appropriate unlisted code
Include product name, HCPCS (if applicable), NDC or manufacturer, and volume/quantity in documentation and claim
Code lists in the policy may not be exhaustive; code updates may occur more frequently than policy updates

Documentation Required

Documentation to Support rhBMP Requests

Documentation submitted with prior authorization or claims should specifically support any rhBMP-2 request that meets FDA-labeled criteria (for example, for open tibial shaft fractures: documentation of IM nail fixation, timing of application within 14 days of initial fracture, and skeletal maturity). For rhBMP-7 (OP-1) under its HDE approval, documentation must demonstrate autograft infeasibility and prior failure of alternative treatments.

For rhBMP-2 (INFUSE®): document IM nail fixation, application within 14 days of fracture, skeletal maturity, and absence of contraindications
For rhBMP-7 (OP-1 HDE): document that autograft is not feasible and that alternative treatments have failed (historical HDE requirement)

Note

Regulatory Documentation References

Regulatory and supporting references for product indications and approvals are available and should be cited in complex or exceptional coverage reviews. FDA PMA and HDE decision documents are relevant for rhBMP-2 (INFUSE®) and rhBMP-7 (OP-1) respectively; manufacturers' 510(k)/PMA/De Novo summaries for ceramic and other bone graft substitutes are also referenced in this policy.

INFUSE® PMA (P000054) — open tibial shaft fractures (2004) and subsequent dental indications (2007)
OP-1 HDE (H010002) — rhBMP-7 humanitarian device exemption (2001)
FDA 510(k)/De Novo summaries for ceramic and other bone graft substitutes (see policy references)

Regulatory categories

FDA classifies products as drugs, devices, biological products, or combination products; classification depends on composition (drug, biologic, device) and intended use.

Class II devicesBone grafts intended to fill bony voids or gaps (not intrinsic to structural stability) or to fill/augment oral/maxillofacial defects are generally Class II devices subject to 510(k).

Class III / PMA requirementBone grafts containing drugs are considered therapeutic biologics and are regulated as Class III devices that require Premarket Approval (PMA).

Combination products and cellular materialsCultured cells combined with other materials are considered combination products and may be regulated as devices or biological products; nonstructural and cellular allografts are HCT/P and may not require preclinical/clinical data per FDA rules.

Osteoconduction

DefinitionOsteoconduction = provides a scaffold for bone growth; supports ingrowth of capillaries and osteoprogenitor cells.

Typical materialsExamples include calcium sulfate, ceramics (calcium phosphate), bone cements, and collagen-based scaffolds.

Role in substitutesOsteoconductive properties are common to ceramic- and polymer-based synthetic substitutes and bone void fillers used to provide structural support for new bone formation.

Osteoinduction

DefinitionOsteoinduction = provides growth factors or signals that induce undifferentiated cells to become bone-forming cells.

Example materialsExamples include demineralized bone matrix (DBM) and recombinant bone morphogenetic proteins (rhBMPs).

Functional noteOsteoinductive components are intended to stimulate new bone formation beyond serving as a scaffold.

Osteogenesis

DefinitionOsteogenesis = provides living cells capable of forming bone (osteogenic cells/progenitors).

Example materialsExamples include bone marrow aspirate which contains progenitor cells that can contribute to new bone formation.

Composite roleSome graft substitutes are composites combining osteoconductive scaffolds with osteogenic cells to provide multiple mechanisms for healing.

Premarket Approval (PMA)

DefinitionPremarket Approval (PMA) = FDA approval pathway for higher-risk (Class III) devices requiring demonstration of safety and effectiveness prior to marketing.

INFUSE PMA citationINFUSE BONE GRAFT (rhBMP-2) received PMA with decision date 04/30/2004 for acute, open tibial shaft fractures (IM nail fixation).

Provider implicationCoverage and documentation should align with PMA-labeled indications (e.g., stabilization with IM nail and application within specified timeframe).

Humanitarian Device Exemption (HDE)

DefinitionHumanitarian Device Exemption (HDE) = FDA pathway to market for devices intended to treat or diagnose conditions affecting a small number of patients; exempt from effectiveness requirements but must demonstrate probable benefit and safety.

OP-1 HDE citationOP-1 IMPLANT (rhBMP-7) HDE number H010002 decision date 10/17/2001 is cited as the HDE approval for rhBMP-7.

Coverage stanceDespite prior HDE approval, rhBMP-7 (OP-1) is considered experimental/investigational/unproven for all indications in this policy.

Focused review removed spine-related policy statements and delegated spine indications to EviCore effective 11/01/2024.

2024-02-15Annual review - revised policy statement

Annual review revised the policy statement for bone graft materials and/or substitutes.